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APPROVED

DRUG
PRODUCTS
WITH
THERAPEUTIC
EQUIVALENCE
EVALUATIONS
34
th
EDITION
THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER
SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
OFFICE OF GENERIC DRUGS
2014




























APPROVED DRUG PRODUCTS
with
THERAPEUTIC EQUIVALENCE EVALUATIONS
The products in this list have been approved under section 505 of the
Federal Food, Drug, and Cosmetic Act. This volume is current through
December 31, 2013.
34
th
EDITION
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
OFFICE OF GENERIC DRUGS
2014













































FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
APPROVED DRUG PRODUCTS
with
Therapeutic Equivalence Evaluations
CONTENTS
PAGE
PREFACE TO THIRTY FOURTH EDITION..................iv
1 INTRODUCTION...................................................................................................................vi
1.1 Content and Exclusion......................................................................................................vi
1.2 Therapeutic Equivalence-Related Terms .........................................................................vi
1.3 Statistical Criteria for Bioequivalence............................................................................. viii
1.4 Reference Listed Drug.......................................................................................................x
1.5 General Policies and Legal Status ................................................................................... xi
1.6 Practitioner/User Responsibilities..................................................................................... xi
1.7 Therapeutic Equivalence Evaluations Codes................................................................. xiii
1.8 Description of Special Situations ..................................................................................... xx
1.9 Therapeutic Equivalence Code Change for a Drug Entity ............................................. xxii
1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product .................... xxiii
1.11 Discontinued Section .................................................................................................... xxiii
1.12 Changes to the Orange Book ....................................................................................... xxiii
1.13 Availability of the Edition ............................................................................................... xxiv
2 HOW TO USE THE DRUG PRODUCTS LISTS ..............................................................2-1
2.1 Key Sections for Using the Drug Product Lists ........2-1
2.2 Drug Product Illustration ......2-3
2.3 Therapeutic Equivalence Evaluations Illustration ....2-4
DRUG PRODUCT LISTS
Prescription Drug Product List .....3-1
OTC Drug Product List ..4-1
Drug Products with Approval under Section 505 of the Act Administered
Drug Products Which Must Demonstrate in vivo Bioavailability
by the Center for Biologics Evaluation and Research List ........5-1
Discontinued Drug Product List .......6-1
Orphan Products Designations and Approvals List .....7-1
Only if Product Fails to Achieve Adequate Dissolution ....8-1
APPENDICES
A. Product Name Index .......A-1
B. Product Name Index Listed by Applicant .....B-1
C. Uniform Terms .........C-1
PATENT AND EXCLUSIVITY INFORMATION ADDENDUM .............AD1
A. Patent and Exclusivity Lists .......ADA1
B. Patent and Exclusivity Terms ........ADB1











FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
APPROVED DRUG PRODUCTS
with
Therapeutic Equivalence Evaluations
PREFACE TO THIRTY FOURTH EDITION
The publ i cat i on, Approved Drug Products with Therapeutic Equivalence
Evaluations ( t he Li st , commonl y known as t he Or ange Book) , i dent i f i es dr ug
pr oduct s appr oved on t he basi s of saf et y and ef f ect i veness by t he Food and
Dr ug Admi ni st r at i on ( FDA) under t he Feder al Food, Dr ug, and Cosmet i c Act ( t he
Act ) . Dr ugs on t he mar ket appr oved onl y on t he basi s of saf et y ( cover ed by
t he ongoi ng Dr ug Ef f i cacy St udy I mpl ement at i on [ DESI ] r evi ew [ e. g. , Donnat al
Tabl et s and Li br ax Capsul es] or pr e- 1938 dr ugs [ e. g. , Phenobar bi t al
Tabl et s] ) ar e not i ncl uded i n t hi s publ i cat i on. The mai n cr i t er i on f or t he
i ncl usi on of any pr oduct i s t hat t he pr oduct i s t he subj ect of an appl i cat i on
wi t h an ef f ect i ve appr oval t hat has not been wi t hdr awn f or saf et y or ef f i cacy
r easons. I ncl usi on of pr oduct s on t he Li st i s i ndependent of any cur r ent
r egul at or y act i on t hr ough admi ni st r at i ve or j udi ci al means agai nst a dr ug
pr oduct . I n addi t i on, t he Li st cont ai ns t her apeut i c equi val ence eval uat i ons
f or appr oved mul t i sour ce pr escr i pt i on dr ug pr oduct s. These eval uat i ons have
been pr epar ed t o ser ve as publ i c i nf or mat i on and advi ce t o st at e heal t h
agenci es, pr escr i ber s, and phar maci st s t o pr omot e publ i c educat i on i n t he ar ea
of dr ug pr oduct sel ect i on and t o f ost er cont ai nment of heal t h car e cost s.
Ther apeut i c equi val ence eval uat i ons i n t hi s publ i cat i on ar e not of f i ci al FDA
act i ons af f ect i ng t he l egal st at us of pr oduct s under t he Act .
Background of the Publication. To cont ai n dr ug cost s, vi r t ual l y ever y
st at e has adopt ed l aws and/ or r egul at i ons t hat encour age t he subst i t ut i on of
dr ug pr oduct s. These st at e l aws gener al l y r equi r e ei t her t hat subst i t ut i on be
l i mi t ed t o dr ugs on a speci f i c l i st ( t he posi t i ve f or mul ar y appr oach) or t hat
i t be per mi t t ed f or al l dr ugs except t hose pr ohi bi t ed by a par t i cul ar l i st
( t he negat i ve f or mul ar y appr oach) . Because of t he number of r equest s i n t he
l at e 1970s f or FDA assi st ance i n pr epar i ng bot h posi t i ve and negat i ve
f or mul ar i es, i t became appar ent t hat FDA coul d not ser ve t he needs of each
st at e on an i ndi vi dual basi s. The Agency al so r ecogni zed t hat pr ovi di ng a
si ngl e l i st based on common cr i t er i a woul d be pr ef er abl e t o eval uat i ng dr ug
pr oduct s on t he basi s of di f f er i ng def i ni t i ons and cr i t er i a i n var i ous st at e
l aws. As a r esul t , on May 31, 1978, t he Commi ssi oner of t he Food and Dr ug
Admi ni st r at i on sent a l et t er t o of f i ci al s of each st at e st at i ng FDA' s i nt ent
t o pr ovi de a l i st of al l pr escr i pt i on dr ug pr oduct s t hat ar e appr oved by FDA
f or saf et y and ef f ect i veness, al ong wi t h t her apeut i c equi val ence
det er mi nat i ons f or mul t i sour ce pr escr i pt i on pr oduct s.
The Li st was di st r i but ed as a pr oposal i n J anuar y l 979. I t i ncl uded onl y
cur r ent l y mar ket ed pr escr i pt i on dr ug pr oduct s appr oved by FDA t hr ough new dr ug
appl i cat i ons ( NDAs) and abbr evi at ed new dr ug appl i cat i ons ( ANDAs) under t he
pr ovi si ons of Sect i on 505 of t he Act .
The t her apeut i c equi val ence eval uat i ons i n t he Li st r ef l ect FDA' s
appl i cat i on of speci f i c cr i t er i a t o t he mul t i sour ce pr escr i pt i on dr ug pr oduct s
on t he Li st appr oved under Sect i on 505 of t he Act . These eval uat i ons ar e
pr esent ed i n t he f or mof code l et t er s t hat i ndi cat e t he basi s f or t he
eval uat i on made. An expl anat i on of t he code appear s i n t he Introduction.
A compl et e di scussi on of t he backgr ound and basi s of FDA' s t her apeut i c
equi val ence eval uat i on pol i cy was publ i shed i n t he Federal Register on
J anuar y 12, 1979 ( 44 FR 2932) . The f i nal r ul e, whi ch i ncl udes FDA' s r esponses
t o t he publ i c comment s on t he pr oposal , was publ i shed i n t he Federal Register
iv



on Oct ober 31, 1980 ( 45 FR 72582) . The f i r st publ i cat i on, Oct ober 1980, of
t he f i nal ver si on of t he Li st i ncor por at ed appr opr i at e cor r ect i ons and
addi t i ons. Each subsequent edi t i on has i ncl uded t he new appr oval s and made
appr opr i at e changes i n dat a.
On Sept ember 24, 1984, t he Pr esi dent si gned i nt o l aw t he Dr ug Pr i ce
Compet i t i on and Pat ent Ter mRest or at i on Act ( 1984 Amendment s) . The 1984
Amendment s r equi r e t hat FDA, among ot her t hi ngs, make publ i cl y avai l abl e a
l i st of appr oved dr ug pr oduct s wi t h mont hl y suppl ement s. The Approved Drug
Products with Therapeutic Equivalence Evaluations publ i cat i on and i t s mont hl y
Cumul at i ve Suppl ement s sat i sf y t hi s r equi r ement . The Addendum t o t hi s
publ i cat i on i dent i f i es dr ugs t hat qual i f y under t he 1984 Amendment s f or
per i ods of excl usi vi t y ( dur i ng whi ch ANDAs or appl i cat i ons descr i bed i n
Sect i on 505( b) ( 2) of t he Act f or t hose dr ugs may not be submi t t ed f or a
speci f i ed per i od of t i me and, i f al l owed t o be submi t t ed, woul d be t ent at i vel y
appr oved) and pr ovi des pat ent i nf or mat i on concer ni ng t he l i st ed dr ugs whi ch
al so may del ay t he appr oval of ANDAs or Sect i on 505( b) ( 2) appl i cat i ons. The
Addendum al so pr ovi des addi t i onal i nf or mat i on t hat may be hel pf ul t o t hose
submi t t i ng a new dr ug appl i cat i on t o t he Agency.
The Agency i nt ends t o use t hi s publ i cat i on t o f ur t her i t s obj ect i ve of
obt ai ni ng i nput and comment on t he publ i cat i on i t sel f and r el at ed Agency
pr ocedur es. Ther ef or e, i f you have comment s on how t he publ i cat i on can be
i mpr oved, pl ease send t hemt o t he Di r ect or , Di vi si on of Label i ng and Pr ogr am
Suppor t , HFD- 610, Of f i ce of Gener i c Dr ugs, Cent er f or Dr ug and Eval uat i on and
Resear ch, 7620 St andi sh Pl ace, Rockvi l l e, MD 20855. Comment s r ecei ved ar e
publ i cl y avai l abl e t o t he ext ent al l owabl e under t he Fr eedomof I nf or mat i on
r egul at i ons.
v


















1. INTRODUCTION
1.1 Content and Exclusion
The Li st i s composed of f our par t s: ( 1) appr oved pr escr i pt i on dr ug
pr oduct s wi t h t her apeut i c equi val ence eval uat i ons; ( 2) appr oved
over - t he- count er ( OTC) dr ug pr oduct s f or t hose dr ugs t hat may not be mar ket ed
wi t hout NDAs or ANDAs because t hey ar e not cover ed under exi st i ng OTC
monogr aphs; ( 3) dr ug pr oduct s wi t h appr oval under Sect i on 505 of t he Act
admi ni st er ed by t he Cent er f or Bi ol ogi cs Eval uat i on and Resear ch; and ( 4) a
cumul at i ve l i st of appr oved pr oduct s t hat have never been mar ket ed, ar e f or
expor t at i on, ar e f or mi l i t ar y use, have been di scont i nued f r ommar ket i ng, or
have had t hei r appr oval s wi t hdr awn f or ot her t han saf et y or ef f i cacy r easons
subsequent t o bei ng di scont i nued f r ommar ket i ng.
1
Thi s publ i cat i on al so
i ncl udes i ndi ces of pr escr i pt i on and OTC dr ug pr oduct s by t r ade or est abl i shed
name ( i f no t r ade name exi st s) and by appl i cant name ( hol der of t he appr oved
appl i cat i on) . Al l est abl i shed names f or act i ve i ngr edi ent s gener al l y conf or m
t o of f i ci al compendi al names or United States Adopted Names ( USAN) as
pr escr i bed i n ( 21 CFR 299. 4( e) ) . The l at t er l i st i ncl udes appl i cant s names
as abbr evi at ed i n t hi s publ i cat i on; i n addi t i on, a l i st of uni f or mt er ms i s
pr ovi ded.
An Addendum cont ai ns dr ug pat ent and excl usi vi t y i nf or mat i on f or t he
Pr escr i pt i on, OTC, Di scont i nued Dr ug Pr oduct Li st s, and f or t he Dr ug Pr oduct s
wi t h Appr oval under Sect i on 505 of t he Act Admi ni st er ed by t he Cent er f or
Bi ol ogi cs Eval uat i on and Resear ch. The publ i cat i on may i ncl ude addi t i onal
i nf or mat i on t hat t he Agency deems appr opr i at e t o di ssemi nat e.
Pr i or t o t he 6t h Edi t i on, t he publ i cat i on had excl uded OTC dr ug pr oduct s
and dr ug pr oduct s wi t h appr oval under Sect i on 505 of t he Act admi ni st er ed by
t he Cent er f or Bi ol ogi cs Eval uat i on and Resear ch because t he mai n pur pose of
t he publ i cat i on was t o pr ovi de i nf or mat i on t o st at es r egar di ng FDA' s
r ecommendat i on as t o whi ch gener i c pr escr i pt i on dr ug pr oduct s wer e accept abl e
candi dat es f or dr ug pr oduct sel ect i on. The 1984 Amendment s r equi r ed t he
Agency t o begi n publ i shi ng an up- t o- dat e l i st of al l mar ket ed dr ug pr oduct s,
OTC as wel l as pr escr i pt i on, t hat have been appr oved f or saf et y and ef f i cacy
and f or whi ch new dr ug appl i cat i ons ar e r equi r ed.
Under t he 1984 Amendment s, some dr ug pr oduct s ar e gi ven t ent at i ve
appr oval s. The Agency wi l l not i ncl ude dr ug pr oduct s wi t h t ent at i ve appr oval
i n t he Li st . Tent at i ve appr oval l i st s ar e avai l abl e at ANDA ( Gener i c) Dr ug
Appr oval s. When t he t ent at i ve appr oval becomes a f ul l appr oval t hr ough a
subsequent act i on l et t er t o t he appl i cat i on hol der , t he Agency wi l l l i st t he
dr ug pr oduct and t he f i nal appr oval dat e i n t he appr opr i at e appr oved dr ug
pr oduct l i st .
Di st r i but or s or r epackager s of pr oduct s on t he Li st ar e not i dent i f i ed.
Because di st r i but or s or r epackager s ar e not r equi r ed t o not i f y FDA when t hey
shi f t t hei r sour ces of suppl y f r omone appr oved manuf act ur er t o anot her , i t i s
not possi bl e t o mai nt ai n compl et e i nf or mat i on l i nki ng pr oduct appr oval wi t h
t he di st r i but or or r epackager handl i ng t he pr oduct s.
1.2 Therapeutic Equivalence-Related Terms
Pharmaceutical Equivalents. Dr ug pr oduct s ar e consi der ed phar maceut i cal
equi val ent s i f t hey cont ai n t he same act i ve i ngr edi ent ( s) , ar e of t he same
1
Newl y appr oved pr oduct s ar e added t o par t s 1, 2, or 3, of t he Li st , dependi ng on t he di spensi ng
r equi r ement s ( pr escr i pt i on or OTC) or appr oval aut hor i t y, unl ess t he Or ange Book st af f i s
ot her wi se not i f i ed bef or e publ i cat i on.
vi






dosage f or m, r out e of admi ni st r at i on and ar e i dent i cal i n st r engt h or
concent r at i on ( e. g. , chl or di azepoxi de hydr ochl or i de, 5mg capsul es) .
Phar maceut i cal l y equi val ent dr ug pr oduct s ar e f or mul at ed t o cont ai n t he same
amount of act i ve i ngr edi ent i n t he same dosage f or mand t o meet t he same or
compendi al or ot her appl i cabl e st andar ds ( i . e. , st r engt h, qual i t y, pur i t y, and
i dent i t y) , but t hey may di f f er i n char act er i st i cs such as shape, scor i ng
conf i gur at i on, r el ease mechani sms, packagi ng, exci pi ent s ( i ncl udi ng col or s,
f l avor s, pr eser vat i ves) , expi r at i on t i me, and, wi t hi n cer t ai n l i mi t s,
l abel i ng.
Pharmaceutical Alternatives. Dr ug pr oduct s ar e consi der ed phar maceut i cal
al t er nat i ves i f t hey cont ai n t he same t her apeut i c moi et y, but ar e di f f er ent
sal t s, est er s, or compl exes of t hat moi et y, or ar e di f f er ent dosage f or ms or
st r engt hs ( e. g. , t et r acycl i ne hydr ochl or i de, 250mg capsul es vs. t et r acycl i ne
phosphat e compl ex, 250mg capsul es; qui ni di ne sul f at e, 200mg t abl et s vs.
qui ni di ne sul f at e, 200mg capsul es) . Dat a ar e gener al l y not avai l abl e f or FDA
t o make t he det er mi nat i on of t abl et t o capsul e bi oequi val ence. Di f f er ent
dosage f or ms and st r engt hs wi t hi n a pr oduct l i ne by a si ngl e manuf act ur er ar e
t hus phar maceut i cal al t er nat i ves, as ar e ext ended- r el ease pr oduct s when
compar ed wi t h i mmedi at e- r el ease or st andar d- r el ease f or mul at i ons of t he same
act i ve i ngr edi ent .
Therapeutic Equivalents. Dr ug pr oduct s ar e consi der ed t o be t her apeut i c
equi val ent s onl y i f t hey ar e phar maceut i cal equi val ent s and i f t hey can be
expect ed t o have t he same cl i ni cal ef f ect and saf et y pr of i l e when admi ni st er ed
t o pat i ent s under t he condi t i ons speci f i ed i n t he l abel i ng.
FDA cl assi f i es as t her apeut i cal l y equi val ent t hose pr oduct s t hat meet t he
f ol l owi ng gener al cr i t er i a: ( 1) t hey ar e appr oved as saf e and ef f ect i ve; ( 2)
t hey ar e phar maceut i cal equi val ent s i n t hat t hey ( a) cont ai n i dent i cal amount s
of t he same act i ve dr ug i ngr edi ent i n t he same dosage f or mand r out e of
admi ni st r at i on, and ( b) meet compendi al or ot her appl i cabl e st andar ds of
st r engt h, qual i t y, pur i t y, and i dent i t y; ( 3) t hey ar e bi oequi val ent i n t hat
( a) t hey do not pr esent a known or pot ent i al bi oequi val ence pr obl em, and t hey
meet an accept abl e in vitro st andar d, or ( b) i f t hey do pr esent such a known
or pot ent i al pr obl em, t hey ar e shown t o meet an appr opr i at e bi oequi val ence
st andar d; ( 4) t hey ar e adequat el y l abel ed; ( 5) t hey ar e manuf act ur ed i n
compl i ance wi t h Cur r ent Good Manuf act ur i ng Pr act i ce r egul at i ons. The concept
of therapeutic equivalence, as used to develop the List, applies only to drug
products containing the same active ingredient(s) and does not encompass a
comparison of different therapeutic agents used for the same condition (e.g.,
propoxyphene hydrochloride vs. pentazocine hydrochloride for the treatment of
pain). Any dr ug pr oduct i n t he Li st r epackaged and/ or di st r i but ed by ot her
t han t he appl i cat i on hol der i s consi der ed t o be t her apeut i cal l y equi val ent t o
t he appl i cat i on hol der ' s dr ug pr oduct even i f t he appl i cat i on hol der ' s dr ug
pr oduct i s si ngl e sour ce or coded as non- equi val ent ( e. g. , BN) . Al so,
di st r i but or s or r epackager s of an appl i cat i on hol der ' s dr ug pr oduct ar e
consi der ed t o have t he same code as t he appl i cat i on hol der . Ther apeut i c
equi val ence det er mi nat i ons ar e not made f or unappr oved, of f - l abel i ndi cat i ons.
FDA consi der s dr ug pr oduct s t o be t her apeut i cal l y equi val ent i f t hey meet
t he cr i t er i a out l i ned above, even t hough t hey may di f f er i n cer t ai n ot her
char act er i st i cs such as shape, scor i ng conf i gur at i on, r el ease mechani sms,
packagi ng, exci pi ent s ( i ncl udi ng col or s, f l avor s, pr eser vat i ves) , expi r at i on
dat e/ t i me and mi nor aspect s of l abel i ng ( e. g. , t he pr esence of speci f i c
phar macoki net i c i nf or mat i on) and st or age condi t i ons. When such di f f er ences
ar e i mpor t ant i n t he car e of a par t i cul ar pat i ent , i t may be appr opr i at e f or
t he pr escr i bi ng physi ci an t o r equi r e t hat a par t i cul ar br and be di spensed as a
medi cal necessi t y. Wi t h t hi s l i mi t at i on, however , FDA bel i eves t hat pr oduct s
cl assi f i ed as t her apeut i cal l y equi val ent can be subst i t ut ed wi t h t he f ul l
expect at i on t hat t he subst i t ut ed pr oduct wi l l pr oduce t he same cl i ni cal ef f ect
and saf et y pr of i l e as t he pr escr i bed pr oduct .
Bioavailability. Thi s t er mmeans t he r at e and ext ent t o whi ch t he act i ve
i ngr edi ent or act i ve moi et y i s absor bed f r oma dr ug pr oduct and becomes
vii
















avai l abl e at t he si t e of act i on. For dr ug pr oduct s t hat ar e not i nt ended t o
be absor bed i nt o t he bl oodst r eam, bi oavai l abi l i t y may be assessed by
measur ement s i nt ended t o r ef l ect t he r at e and ext ent t o whi ch t he act i ve
i ngr edi ent or act i ve moi et y becomes avai l abl e at t he si t e of act i on.
Bioequivalent Drug Products. Thi s t er mdescr i bes phar maceut i cal equi val ent
or phar maceut i cal al t er nat i ve pr oduct s t hat di spl ay compar abl e bi oavai l abi l i t y
when st udi ed under si mi l ar exper i ment al condi t i ons. Sect i on 505 ( j ) ( 8) ( B) of
t he Act descr i bes one set of condi t i ons under whi ch a t est and r ef er ence
l i st ed dr ug ( see Sect i on 1. 4) shal l be consi der ed bi oequi val ent :
t he r at e and ext ent of absor pt i on of t he t est dr ug do not show a
si gni f i cant di f f er ence f r omt he r at e and ext ent of absor pt i on of t he
r ef er ence dr ug when admi ni st er ed at t he same mol ar dose of t he
t her apeut i c i ngr edi ent under si mi l ar exper i ment al condi t i ons i n ei t her
a si ngl e dose or mul t i pl e doses; or
t he ext ent of absor pt i on of t he t est dr ug does not show a si gni f i cant
di f f er ence f r omt he ext ent of absor pt i on of t he r ef er ence dr ug when
admi ni st er ed at t he same mol ar dose of t he t her apeut i c i ngr edi ent under
si mi l ar exper i ment al condi t i ons i n ei t her a si ngl e dose or mul t i pl e
doses and t he di f f er ence f r omt he r ef er ence dr ug i n t he r at e of
absor pt i on of t he dr ug i s i nt ent i onal , i s r ef l ect ed i n i t s pr oposed
l abel i ng, i s not essent i al t o t he at t ai nment of ef f ect i ve body dr ug
concent r at i ons on chr oni c use, and i s consi der ed medi cal l y
i nsi gni f i cant f or t he dr ug.
Wher e t hese above met hods ar e not appl i cabl e ( e. g. , f or dr ug pr oduct s t hat
ar e not i nt ended t o be absor bed i nt o t he bl oodst r eam) , ot her in vivo or in
vitro t est met hods t o demonst r at e bi oequi val ence may be appr opr i at e.
Bi oequi val ence may somet i mes be demonst r at ed usi ng an in vitro
bi oequi val ence st andar d, especi al l y when such an in vitro t est has been
cor r el at ed wi t h human i n vivo bi oavai l abi l i t y dat a. I n ot her si t uat i ons,
bi oequi val ence may somet i mes be demonst r at ed t hr ough compar at i ve cl i ni cal
t r i al s or phar macodynami c st udi es.
1.3 Statistical Criteria for Bioequivalence
Under t he Dr ug Pr i ce Compet i t i on and Pat ent Ter mRest or at i on Act of 1984,
manuf act ur er s seeki ng appr oval t o mar ket a gener i c dr ug pr oduct must submi t
dat a demonst r at i ng t hat t he dr ug pr oduct i s bi oequi val ent t o t he pi oneer
( i nnovat or ) dr ug pr oduct . A maj or pr emi se under l yi ng t he 1984 l aw i s t hat
bi oequi val ent dr ug pr oduct s ar e t her apeut i cal l y equi val ent , and t her ef or e,
i nt er changeabl e.
Bi oavai l abi l i t y r ef er s t o t he r at e and ext ent t o whi ch t he act i ve
i ngr edi ent or t her apeut i c i ngr edi ent i s absor bed f r oma dr ug pr oduct and
becomes avai l abl e at t he si t e of dr ug act i on ( Feder al Food, Dr ug and Cosmet i c
Act , sect i on 505( j ) ( 8) ) . Bi oequi val ence r ef er s t o equi val ent r el ease of t he
same dr ug subst ance f r omt wo or mor e dr ug pr oduct s or f or mul at i ons. Thi s
l eads t o an equi val ent r at e and ext ent of absor pt i on f r omt hese f or mul at i ons.
Under l yi ng t he concept of bi oequi val ence i s t he t hesi s t hat , i f a dr ug pr oduct
cont ai ns a dr ug subst ance t hat i s chemi cal l y i dent i cal and i s del i ver ed t o t he
si t e of act i on at t he same r at e and ext ent as anot her dr ug pr oduct , t hen i t i s
equi val ent and can be subst i t ut ed f or t hat dr ug pr oduct . Met hods used t o
def i ne bi oequi val ence can be f ound i n 21 CFR 320. 24, and i ncl ude ( 1)
phar macoki net i c ( PK) st udi es, ( 2) phar macodynami c ( PD) st udi es, ( 3)
compar at i ve cl i ni cal t r i al s, and ( 4) i n- vi t r o st udi es. The choi ce of st udy
used i s based on t he si t e of act i on of t he dr ug and t he abi l i t y of t he st udy
desi gn t o compar e dr ug del i ver ed t o t hat si t e by t he t wo pr oduct s.
The st andar d bi oequi val ence ( PK) st udy i s conduct ed usi ng a t wo- t r eat ment
cr ossover st udy desi gn i n a l i mi t ed number of vol unt eer s, usual l y 24 t o 36
viii











adul t s. Al t er nat el y, a f our - per i od, r epl i cat e desi gn cr ossover st udy may al so
be used. Si ngl e doses of t he t est and r ef er ence dr ug pr oduct s ar e
admi ni st er ed and bl ood or pl asma l evel s of t he dr ug ar e measur ed over t i me.
Phar macoki net i c par amet er s char act er i zi ng r at e and ext ent of dr ug absor pt i on
ar e eval uat ed st at i st i cal l y. The PK par amet er s of i nt er est ar e t he r esul t i ng
ar ea under t he pl asma concent r at i on- t i me cur ve ( AUC) , cal cul at ed t o t he l ast
measur ed concent r at i on ( AUC
( 0- t )
) and ext r apol at ed t o i nf i ni t y ( AUC
( 0- i nf )
) , f or
ext ent of absor pt i on; and t he maxi mumor peak dr ug concent r at i ons ( Cmax) , f or
r at e of absor pt i on. Cr ossover st udi es may not be pr act i cal i n dr ugs wi t h a
l ong hal f - l i f e i n t he body, and a par al l el st udy desi gn may be used i nst ead.
Al t er nat e st udy met hods, such as i n- vi t r o st udi es or equi val ence st udi es wi t h
cl i ni cal or phar macodynami c endpoi nt s, ar e used f or dr ug pr oduct s wher e pl asma
concent r at i ons ar e not usef ul t o det er mi ne del i ver y of t he dr ug subst ance t o
t he si t e of act i vi t y ( such as i nhal er s, nasal spr ays and t opi cal pr oduct s
appl i ed t o t he ski n) .
The st at i st i cal met hodol ogy f or anal yzi ng t hese bi oequi val ence st udi es i s
cal l ed t he t wo one- si ded t est pr ocedur e. Two si t uat i ons ar e t est ed wi t h t hi s
st at i st i cal met hodol ogy. The f i r st of t he t wo one- si ded t est s det er mi nes
whet her a gener i c pr oduct ( t est ) , when subst i t ut ed f or a br and- name pr oduct
( r ef er ence) i s si gni f i cant l y l ess bi oavai l abl e. The second of t he t wo one-
si ded t est s det er mi nes whet her a br and- name pr oduct when subst i t ut ed f or a
gener i c pr oduct i s si gni f i cant l y l ess bi oavai l abl e. Based on t he opi ni ons of
FDA medi cal exper t s, a di f f er ence of gr eat er t han 20%f or each of t he above
t est s was det er mi ned t o be si gni f i cant , and t her ef or e, undesi r abl e f or al l
dr ug pr oduct s. Numer i cal l y, t hi s i s expr essed as a l i mi t of t est - pr oduct
aver age/ r ef er ence- pr oduct aver age of 80%f or t he f i r st st at i st i cal t est and a
l i mi t of r ef er ence- pr oduct aver age/ t est - pr oduct aver age of 80%f or t he second
st at i st i cal t est . By convent i on, al l dat a i s expr essed as a r at i o of t he
aver age r esponse ( AUC and Cmax) f or t est / r ef er ence, so t he l i mi t expr essed i n
t he second st at i st i cal t est i s 125%( r eci pr ocal of 80%) .
For st at i st i cal r easons, al l dat a i s l og- t r ansf or med pr i or t o conduct i ng
st at i st i cal t est i ng. I n pr act i ce, t hese st at i st i cal t est s ar e car r i ed out
usi ng an anal ysi s of var i ance pr ocedur e ( ANOVA) and cal cul at i ng a 90%
conf i dence i nt er val f or each phar macoki net i c par amet er ( Cmax and AUC) . The
conf i dence i nt er val f or bot h phar macoki net i c par amet er s, AUC and Cmax, must be
ent i r el y wi t hi n t he 80%t o 125%boundar i es ci t ed above. Because t he mean of
t he st udy dat a l i es i n t he cent er of t he 90%conf i dence i nt er val , t he mean of
t he dat a i s usual l y cl ose t o 100%( a t est / r ef er ence r at i o of 1) . Di f f er ent
st at i st i cal cr i t er i a ar e somet i mes used when bi oequi val ence i s demonst r at ed
t hr ough compar at i ve cl i ni cal t r i al s phar macodynami c st udi es, or compar at i ve
i n- vi t r o met hodol ogy.
The bi oequi val ence met hodol ogy and cr i t er i a descr i bed above si mul t aneousl y
cont r ol f or bot h di f f er ences i n t he aver age r esponse bet ween t est and
r ef er ence, as wel l as t he pr eci si on wi t h whi ch t he aver age r esponse i n t he
popul at i on i s est i mat ed. Thi s pr eci si on depends on t he wi t hi n- subj ect ( nor mal
vol unt eer or pat i ent ) var i abi l i t y i n t he phar macoki net i c par amet er s ( AUC and
Cmax) of t he t wo pr oduct s and on t he number of subj ect s i n t he st udy. The
wi dt h of t he 90%conf i dence i nt er val i s a r ef l ect i on i n par t of t he wi t hi n-
subj ect var i abi l i t y of t he t est and r ef er ence pr oduct s i n t he bi oequi val ence
st udy. A t est pr oduct wi t h no di f f er ences i n t he aver age r esponse when
compar ed t o t he r ef er ence mi ght st i l l f ai l t o pass t he bi oequi val ence cr i t er i a
i f t he var i abi l i t y of one or bot h pr oduct s i s hi gh and t he bi oequi val ence
st udy has i nsuf f i ci ent st at i st i cal power ( i . e. , i nsuf f i ci ent number of
subj ect s) . Li kewi se, a t est pr oduct wi t h l ow var i abi l i t y may pass t he
bi oequi val ence cr i t er i a, when t her e ar e somewhat l ar ger di f f er ences i n t he
aver age r esponse.
Thi s syst emof assessi ng bi oequi val ence of gener i c pr oduct s assur es t hat
t hese subst i t ut abl e pr oduct s do not devi at e subst ant i al l y i n i n- vi vo
per f or mance f r omt he r ef er ence pr oduct . The Of f i ce of Gener i c Dr ugs has
conduct ed t wo sur veys t o quant i f y t he di f f er ences bet ween gener i c and br and
name pr oduct s. The f i r st sur vey i ncl uded 224 bi oequi val ence st udi es submi t t ed
ix


















i n appr oved appl i cat i ons dur i ng 1985 and 1986. The obser ved aver age
di f f er ences bet ween r ef er ence and gener i c pr oduct s f or AUC was 3. 5%( J AMA,
Sept . 4, 1987, Vol . 258, No. 9) . The second sur vey i ncl uded 127
bi oequi val ence st udi es submi t t ed t o t he agency i n 273 ANDAs appr oved i n 1997.
The t hr ee measur es r evi ewed i ncl ude AUC
( 0- t ) ,
AUC
( 0- i nf )
, and Cmax. The obser ved
aver age di f f er ences bet ween t he r ef er ence and gener i c pr oduct s wer e + 3. 47%
( SD 2. 84) f or AUC
( 0- t )
, + 3. 25%( SD 2. 97) f or AUC
( 0- i nf )
, and + 4. 29%( SD 3. 72)
f or Cmax ( J AMA, Dec. 1, 1999, Vol . 282, No. 21) .
The pr i mar y concer n f r omt he r egul at or y poi nt of vi ew i s t he pr ot ect i on of
t he pat i ent agai nst appr oval of pr oduct s t hat ar e not bi oequi val ent . The
cur r ent pr act i ce of car r yi ng out t wo one- si ded t est s at t he 0. 05 l evel of
si gni f i cance ensur es t hat t her e i s no mor e t han a 5%chance t hat a gener i c
pr oduct t hat i s not t r ul y equi val ent t o t he r ef er ence wi l l be appr oved.
1.4 Reference Listed Drug
A r ef er ence l i st ed dr ug ( 21 CFR 314. 94( a) ( 3) ) means t he l i st ed dr ug
i dent i f i ed by FDA as t he dr ug pr oduct upon whi ch an appl i cant r el i es i n
seeki ng appr oval of i t s ANDA.
FDA has i dent i f i ed i n t he Pr escr i pt i on Dr ug Pr oduct and OTC Dr ug Pr oduct
Li st s t hose r ef er ence l i st ed dr ugs t o whi ch t he in vivo bi oequi val ence
( r ef er ence st andar d) and, i n some i nst ances, t he in vitro bi oequi val ence of
t he appl i cant ' s pr oduct i s compar ed. By desi gnat i ng a si ngl e r ef er ence l i st ed
dr ug as t he st andar d t o whi ch al l gener i c ver si ons must be shown t o be
bi oequi val ent , FDA hopes t o avoi d possi bl e si gni f i cant var i at i ons among
gener i c dr ugs and t hei r br and name count er par t . Such var i at i ons coul d r esul t
i f gener i c dr ugs wer e compar ed t o di f f er ent r ef er ence l i st ed dr ugs. However ,
i n some i nst ances when l i st ed dr ugs ar e appr oved f or a si ngl e dr ug pr oduct , a
pr oduct not desi gnat ed as t he r ef er ence l i st ed dr ug and not shown t o be
bi oequi val ent t o t he r ef er ence l i st ed dr ug may be shi el ded f r omgener i c
compet i t i on. A f i r mwi shi ng t o mar ket a gener i c ver si on of a l i st ed dr ug t hat
i s not desi gnat ed as t he r ef er ence l i st ed dr ug may pet i t i on t he Agency t hr ough
t he Ci t i zen Pet i t i on pr ocedur e ( see 21 CFR 10. 25( a) and CFR 10. 30) . When t he
Ci t i zen Pet i t i on i s appr oved, t he second l i st ed dr ug wi l l be desi gnat ed as an
addi t i onal r ef er ence l i st ed dr ug and t he pet i t i oner may submi t an Abbr evi at ed
New Dr ug Appl i cat i on ci t i ng t he desi gnat ed r ef er ence l i st ed dr ug. Sect i on
1. 7, Therapeutic Equivalence Evaluations Codes products meeting necessary
bioequivalence requirements expl ai ns t he (AB, AB1, AB2, AB3... codi ng syst em
f or mul t i sour ce dr ug pr oduct s l i st ed under t he same headi ng wi t h t wo r ef er ence
l i st ed dr ugs.
I n addi t i on, t her e ar e t wo si t uat i ons i n whi ch t wo l i st ed dr ugs t hat have
been shown t o be bi oequi val ent t o each ot her may bot h be desi gnat ed as
r ef er ence l i st ed dr ugs. The f i r st si t uat i on occur s when t he i n vi vo
det er mi nat i on of bi oequi val ence i s sel f - evi dent and a wai ver of t he in vivo
bi oequi val ence may be gr ant ed. The second si t uat i on occur s when t he
bi oequi val ence of t wo l i st ed pr oduct s may be det er mi ned t hr ough in vitro
met hodol ogy. The r ef er ence l i st ed dr ug i s i dent i f i ed by t he symbol " +" i n t he
Pr escr i pt i on and Over - t he- Count er ( OTC) Dr ug Pr oduct Li st s. These i dent i f i ed
r ef er ence l i st ed dr ugs r epr esent t he best j udgment of t he Di vi si on of
Bi oequi val ence at t hi s t i me. The Pr escr i pt i on and OTC Dr ug Pr oduct Li st s
i dent i f y r ef er ence dr ugs f or or al dosage f or ms, I nj ect abl es, opht hal mi cs,
ot i cs, and t opi cal pr oduct s. I t i s r ecommended t hat a f i r mpl anni ng t o
conduct an in vivo bi oequi val ence st udy, or pl anni ng t o manuf act ur e a bat ch of
a dr ug pr oduct f or whi ch an in vivo wai ver of bi oequi val ence wi l l be
r equest ed, cont act t he Di vi si on of Bi oequi val ence, Of f i ce of Gener i c Dr ugs, t o
conf i r mt he appr opr i at e r ef er ence l i st ed dr ug.
x










1.5 General Policies and Legal Status
The Li st cont ai ns publ i c i nf or mat i on and advi ce. I t does not mandat e t he
dr ug pr oduct s whi ch i s pur chased, pr escr i bed, di spensed, or subst i t ut ed f or
one anot her , nor does i t , conver sel y, mandat e t he pr oduct s t hat shoul d be
avoi ded. To t he ext ent t hat t he Li st set s f or t h FDA' s eval uat i ons of t he
t her apeut i c equi val ence of dr ug pr oduct s t hat have been appr oved, i t cont ai ns
FDA' s advi ce t o t he publ i c, t o pr act i t i oner s and t o t he st at es r egar di ng dr ug
pr oduct sel ect i on. These eval uat i ons do not const i t ut e det er mi nat i ons t hat
any pr oduct i s i n vi ol at i on of t he Act or t hat any pr oduct i s pr ef er abl e t o
any ot her . Ther apeut i c equi val ence eval uat i ons ar e a sci ent i f i c j udgment
based upon evi dence, whi l e gener i c subst i t ut i on may i nvol ve soci al and
economi c pol i cy admi ni st er ed by t he st at es, i nt ended t o r educe t he cost of
dr ugs t o consumer s. To t he ext ent t hat t he Li st i dent i f i es dr ug pr oduct s
appr oved under Sect i on 505 of t he Act , i t set s f or t h i nf or mat i on t hat t he
Agency i s r equi r ed t o publ i sh and t hat t he publ i c i s ent i t l ed t o under t he
Fr eedomof I nf or mat i on Act . Excl usi on of a dr ug pr oduct f r omt he Li st does
not necessar i l y mean t hat t he dr ug pr oduct i s ei t her i n vi ol at i on of Sect i on
505 of t he Act , or t hat such a pr oduct i s not saf e or ef f ect i ve, or t hat such
a pr oduct i s not t her apeut i cal l y equi val ent t o ot her dr ug pr oduct s. Rat her ,
t he excl usi on i s based on t he f act t hat FDA has not eval uat ed t he saf et y,
ef f ect i veness, and qual i t y of t he dr ug pr oduct .
1.6 Practitioner/User Responsibilities
Professional care and judgment should be exercised in using the List.
Eval uat i ons of t her apeut i c equi val ence f or pr escr i pt i on dr ugs ar e based on
sci ent i f i c and medi cal eval uat i ons by FDA. Pr oduct s eval uat ed as
t her apeut i cal l y equi val ent can be expect ed, i n t he j udgment of FDA, t o have
equi val ent cl i ni cal ef f ect and no di f f er ence i n t hei r pot ent i al f or adver se
ef f ect s when used under t he condi t i ons of t hei r l abel i ng. However , t hese
pr oduct s may di f f er i n ot her char act er i st i cs such as shape, scor i ng
conf i gur at i on, r el ease mechani sms, packagi ng, exci pi ent s ( i ncl udi ng col or s,
f l avor s, pr eser vat i ves) , expi r at i on dat e/ t i me, and, i n some i nst ances,
l abel i ng. I f pr oduct s wi t h such di f f er ences ar e subst i t ut ed f or each ot her ,
t her e i s a pot ent i al f or pat i ent conf usi on due t o di f f er ences i n col or or
shape of t abl et s, i nabi l i t y t o pr ovi de a gi ven dose usi ng a par t i al t abl et i f
t he pr oper scor i ng conf i gur at i on i s not avai l abl e, or decr eased pat i ent
accept ance of cer t ai n pr oduct s because of f l avor . Ther e may al so be bet t er
st abi l i t y of one pr oduct over anot her under adver se st or age condi t i ons, or
al l er gi c r eact i ons i n r ar e cases due t o a col or i ng or a pr eser vat i ve
i ngr edi ent , as wel l as di f f er ences i n cost t o t he pat i ent .
FDA eval uat i on of t her apeut i c equi val ence i n no way r el i eves pr act i t i oner s
of t hei r pr of essi onal r esponsi bi l i t i es i n pr escr i bi ng and di spensi ng such
pr oduct s wi t h due car e and wi t h appr opr i at e i nf or mat i on t o i ndi vi dual
pat i ent s. I n t hose ci r cumst ances wher e t he char act er i st i cs of a speci f i c
pr oduct , ot her t han i t s act i ve i ngr edi ent , ar e i mpor t ant i n t he t her apy of a
par t i cul ar pat i ent , t he physi ci an' s speci f i cat i on of t hat pr oduct i s
appr opr i at e. Phar maci st s must al so be f ami l i ar wi t h t he expi r at i on
dat es/ t i mes and l abel i ng di r ect i ons f or st or age of t he di f f er ent pr oduct s,
par t i cul ar l y f or r econst i t ut ed pr oduct s, t o assur e t hat pat i ent s ar e pr oper l y
advi sed when one pr oduct i s subst i t ut ed f or anot her .
Multisource and single-source drug products. FDA has eval uat ed f or
t her apeut i c equi val ence onl y mul t i sour ce pr escr i pt i on dr ug pr oduct s appr oved
under Sect i on 505 of t he Act , whi ch i n most i nst ances means t hose
phar maceut i cal equi val ent s avai l abl e f r ommor e t han one manuf act ur er . For
such pr oduct s, a t her apeut i c equi val ence code i s i ncl uded and, i n addi t i on,
pr oduct i nf or mat i on i s hi ghl i ght ed i n bol d f ace and under l i ned. Those
pr oduct s wi t h appr oved appl i cat i ons t hat ar e si ngl e- sour ce ( i . e. , t her e i s
onl y one appr oved pr oduct avai l abl e f or t hat act i ve i ngr edi ent , dosage f or m,
r out e of admi ni st r at i on, and st r engt h) ar e al so i ncl uded on t he Li st , but no
xi











t her apeut i c equi val ence code i s i ncl uded wi t h such pr oduct s. Any dr ug pr oduct
i n t he Li st r epackaged and/ or di st r i but ed by ot her t han t he appl i cat i on hol der
i s consi der ed t o be t her apeut i cal l y equi val ent t o t he appl i cat i on hol der ' s
dr ug pr oduct even i f t he appl i cat i on hol der ' s dr ug pr oduct i s si ngl e sour ce or
coded as non- equi val ent ( e. g. , BN) . Al so, al t hough not i dent i f i ed i n t he
Li st , di st r i but or s or r epackager s of an appl i cat i on hol der ' s dr ug pr oduct ar e
consi der ed t o have t he same code as t he appl i cat i on hol der . The det ai l s of
t hese codes and t he pol i ci es under l yi ng t hemar e di scussed i n Sect i on 1. 7,
Therapeutic Equivalence Evaluations Codes.
Products on the List are identified by the names of the holders of
approved applications (applicants) who may not necessarily be the manufacturer
of the product. The appl i cant may have had i t s pr oduct manuf act ur ed by a
cont r act manuf act ur er and may si mpl y be di st r i but i ng t he pr oduct f or whi ch i t
has obt ai ned appr oval . I n most i nst ances, however , t he manuf act ur er of t he
pr oduct i s al so t he appl i cant . The name of t he manuf act ur er i s per mi t t ed by
r egul at i on t o appear on t he l abel , even when t he manuf act ur er i s not t he
mar ket er .
Al t hough t he pr oduct s on t he Li st ar e i dent i f i ed by t he names of t he
appl i cant s, ci r cumst ances, such as changi ng cor por at e owner shi p, have
somet i mes made i dent i f i cat i on of t he appl i cant di f f i cul t . The Agency
bel i eves, based on cont i nui ng document r evi ew and communi cat i on wi t h f i r ms,
t hat t he appl i cant desi gnat i ons on t he Li st ar e, i n most cases, cor r ect .
To r el at e f i r mname i nf or mat i on on a pr oduct l abel t o t hat on t he Li st ,
t he f ol l owi ng shoul d be not ed: t he appl i cant ' s name al ways appear s on t he
Li st . Thi s appl i es whet her t he appl i cant ( f i r mname on t he For mFDA 356h i n
t he appl i cat i on) i s t he mar ket er ( f i r mname i n l ar gest l et t er s on t he l abel )
or not . However , t he appl i cant ' s name may not al ways appear on t he l abel of
t he pr oduct .
I f t he appl i cant i s t he mar ket er , i t s name appear s on t he Li st and on t he
l abel ; i f t he appl i cant i s not t he mar ket er , and t he Agency i s awar e of a
cor por at e r el at i onshi p ( e. g. , par ent and subsi di ar y) bet ween t he appl i cant and
t he mar ket er , t he name of t he appl i cant appear s on t he Li st and bot h f i r m
names may appear on t he l abel . Fi r ms wi t h known cor por at e r el at i onshi ps ar e
di spl ayed i n Appendi x B. I f t her e i s no known cor por at e r el at i onshi p bet ween
t he appl i cant and t he mar ket er , t he appl i cant ' s name appear s on t he Li st ;
however , unl ess t he appl i cant i s t he manuf act ur er , packager , or di st r i but or ,
t he appl i cant ' s name may not appear on t he l abel . I n t hi s case, t he
pr act i t i oner , f r oml abel i ng al one, wi l l not be abl e t o r el at e t he mar ket ed
pr oduct t o an appl i cant ci t ed i n t he Li st , and hence t o a speci f i c appr oved
dr ug pr oduct . I n such cases, t o assur e t hat t he pr oduct i n quest i on i s t he
subj ect of an appr oved appl i cat i on, t he f i r mnamed on t he l abel shoul d be
cont act ed.
To r el at e t r ade name ( pr opr i et ar y name) i nf or mat i on on a pr oduct l abel t o
t hat on t he Li st , t he f ol l owi ng shoul d be not ed: i f t he appl i cant i s t he
mar ket er , i t s name appear s on t he Li st and on t he l abel ; i f t he Agency i s
awar e of a cor por at e r el at i onshi p bet ween t he appl i cant and t he mar ket er , t he
t r ade name ( pr opr i et ar y name) of t he dr ug pr oduct ( est abl i shed dr ug name i f no
t r ade name exi st s) appear s on t he Li st . I f a cor por at e r el at i onshi p exi st s
bet ween an appl i cat i on hol der and a mar ket er and bot h f i r ms ar e di st r i but i ng
t he dr ug pr oduct , t he FDA r eser ves t he r i ght t o sel ect t he t r ade name of
ei t her t he mar ket er or t he appl i cat i on hol der t o appear on t he Li st . I f t her e
i s no known cor por at e r el at i onshi p bet ween t he appl i cant and t he mar ket er , t he
est abl i shed dr ug name appear s on t he Li st .
Every product on the List is subject at all times to regulatory action.
Fr omt i me t o t i me, appr oved pr oduct s may be f ound i n vi ol at i on of one or mor e
pr ovi si ons of t he Act . I n such ci r cumst ances, t he Agency wi l l commence
appr opr i at e enf or cement act i on t o cor r ect t he vi ol at i on, i f necessar y, by
secur i ng r emoval of t he pr oduct f r omt he mar ket by vol unt ar y r ecal l , sei zur e,
or ot her enf or cement act i ons. Such r egul at or y act i ons ar e, however ,
xii

























i ndependent of t he i ncl usi on of a pr oduct on t he Li st . The mai n cr i t er i on f or
i ncl usi on of a pr oduct i s t hat i t has an appl i cat i on wi t h an ef f ect i ve
appr oval t hat has not been wi t hdr awn f or saf et y or ef f i cacy r easons. FDA
bel i eves t hat r et ent i on of a vi ol at i ve pr oduct on t he Li st wi l l not have any
si gni f i cant adver se heal t h consequences, because ot her l egal mechani sms ar e
avai l abl e t o t he Agency t o pr event t he pr oduct ' s act ual mar ket i ng. FDA may
however , change a pr oduct ' s t her apeut i c equi val ence r at i ng i f t he
ci r cumst ances gi vi ng r i se t o t he vi ol at i on change or ot her wi se cal l i nt o
quest i on t he dat a upon whi ch t he Agency' s assessment of whet her a pr oduct
meet s t he cr i t er i a f or t her apeut i c equi val ence was made.
1.7 Therapeutic Equivalence Evaluations Codes
The codi ng syst emf or t her apeut i c equi val ence eval uat i ons i s const r uct ed
t o al l ow user s t o det er mi ne qui ckl y whet her t he Agency has eval uat ed a
par t i cul ar appr oved pr oduct as t her apeut i cal l y equi val ent t o ot her
phar maceut i cal l y equi val ent pr oduct s ( f i r st l et t er ) and t o pr ovi de addi t i onal
i nf or mat i on on t he basi s of FDA' s eval uat i ons ( second l et t er ) . Wi t h f ew
except i ons, t he t her apeut i c equi val ence eval uat i on dat e i s t he same as t he
appr oval dat e.
The t wo basi c cat egor i es i nt o whi ch mul t i sour ce dr ugs have been pl aced ar e
i ndi cat ed by t he f i r st l et t er as f ol l ows:
A Drug products that FDA considers to be therapeutically equivalent to
other pharmaceutically equivalent products, i.e., drug products for which:
( 1) t her e ar e no known or suspect ed bi oequi val ence pr obl ems. These ar e
desi gnat ed AA, AN, AO, AP, or AT, dependi ng on t he dosage f or m; or
( 2) act ual or pot ent i al bi oequi val ence pr obl ems have been r esol ved wi t h
adequat e in vivo and/ or in vitro evi dence suppor t i ng
bi oequi val ence. These ar e desi gnat ed AB.
B Drug products that FDA at this time, considers not to be
therapeutically equivalent to other pharmaceutically equivalent products,
i.e.,
dr ug pr oduct s f or whi ch act ual or pot ent i al bi oequi val ence pr obl ems
have not been r esol ved by adequat e evi dence of bi oequi val ence. Of t en
t he pr obl emi s wi t h speci f i c dosage f or ms r at her t han wi t h t he act i ve
i ngr edi ent s. These ar e desi gnat ed BC, BD, BE, BN, BP, BR, BS, BT, BX,
or B*.
I ndi vi dual dr ug pr oduct s have been eval uat ed as t her apeut i cal l y equi val ent
t o t he r ef er ence pr oduct i n accor dance wi t h t he def i ni t i ons and pol i ci es
out l i ned bel ow:
" A" CODES
Drug products that are considered to be therapeutically equivalent to other pharmaceutically
equivalent products.
" A" pr oduct s ar e t hose f or whi ch act ual or pot ent i al bi oequi val ence
pr obl ems have been r esol ved wi t h adequat e in vivo and/ or in vitro evi dence
suppor t i ng bi o- equi val ence. Dr ug pr oduct s desi gnat ed wi t h an " A" code f al l
under one of t wo mai n pol i ci es:
(1) f or t hose act i ve i ngr edi ent s or dosage f or ms f or whi ch no in vivo
bi oequi val ence i ssue i s known or suspect ed, t he i nf or mat i on necessar y t o
show bi oequi val ence bet ween phar maceut i cal l y equi val ent pr oduct s i s
pr esumed and consi der ed sel f - evi dent based on ot her dat a i n t he
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appl i cat i on f or some dosage f or ms ( e. g. , sol ut i ons) or sat i sf i ed f or
sol i d or al dosage f or ms by a showi ng t hat an accept abl e in vitro
di ssol ut i on st andar d i s met . A t her apeut i cal l y equi val ent r at i ng i s
assi gned such pr oduct s so l ong as t hey ar e manuf act ur ed i n accor dance
wi t h Cur r ent Good Manuf act ur i ng Pr act i ce r egul at i ons and meet t he ot her
r equi r ement s of t hei r appr oved appl i cat i ons ( t hese ar e desi gnat ed AA, AN,
AO, AP, or AT, dependi ng on t he dosage f or m, as descr i bed bel ow) ; or
( 2) f or t hose DESI dr ug pr oduct s cont ai ni ng act i ve i ngr edi ent s or dosage
f or ms t hat have been i dent i f i ed by FDA as havi ng act ual or pot ent i al
bi oequi val ence pr obl ems, and f or post - 1962 dr ug pr oduct s i n a dosage
f or mpr esent i ng a pot ent i al bi oequi val ence pr obl em, an eval uat i on of
t her apeut i c equi val ence i s assi gned t o phar maceut i cal equi val ent s onl y
i f t he appr oved appl i cat i on cont ai ns adequat e sci ent i f i c evi dence
est abl i shi ng t hr ough in vivo and/ or in vitro st udi es t he bi oequi val ence
of t he pr oduct t o a sel ect ed r ef er ence pr oduct ( t hese pr oduct s ar e
desi gnat ed as AB) .
Ther e ar e some gener al pr i nci pl es t hat may af f ect t he subst i t ut i on of
phar maceut i cal l y equi val ent pr oduct s i n speci f i c cases. Pr escr i ber s and
di spenser s of dr ugs shoul d be al er t t o t hese pr i nci pl es so as t o deal
appr opr i at el y wi t h si t uat i ons t hat r equi r e pr of essi onal j udgment and
di scr et i on.
Ther e may be l abel i ng di f f er ences among phar maceut i cal l y equi val ent
pr oduct s t hat r equi r e at t ent i on on t he par t of t he heal t h pr of essi onal . For
exampl e, phar maceut i cal l y equi val ent powder s t o be r econst i t ut ed f or
admi ni st r at i on as or al or i nj ect abl e l i qui ds may var y wi t h r espect t o t hei r
expi r at i on t i me or st or age condi t i ons af t er r econst i t ut i on. An FDA eval uat i on
t hat such pr oduct s ar e t her apeut i cal l y equi val ent i s appl i cabl e onl y when each
pr oduct i s r econst i t ut ed, st or ed, and used under t he condi t i ons speci f i ed i n
t he l abel i ng of t hat pr oduct .
The Agency wi l l use not es i n t hi s publ i cat i on t o poi nt out speci al
si t uat i ons such as pot ent i al di f f er ences bet ween t wo dr ug pr oduct s t hat have
been eval uat ed as bi oequi val ent and ot her wi se t her apeut i cal l y equi val ent , when
t hey shoul d be br ought t o t he at t ent i on of heal t h pr of essi onal s. These not es
ar e cont ai ned i n Sect i on 1. 8, Description of Special Situations.
For exampl e, i n r ar e i nst ances, t her e may be var i at i ons among
t her apeut i cal l y equi val ent pr oduct s i n t hei r use or i n condi t i ons of
admi ni st r at i on. Such di f f er ences may be due t o pat ent or excl usi vi t y r i ght s
associ at ed wi t h such use. When such var i at i ons may, i n t he Agency' s opi ni on,
af f ect pr escr i bi ng or subst i t ut i on deci si ons by heal t h pr of essi onal s, a not e
wi l l be added t o Sect i on 1. 8.
Al so, occasi onal l y a si t uat i on may ar i se i n whi ch changes i n a l i st ed dr ug
pr oduct af t er i t s appr oval ( f or exampl e, a change i n dosi ng i nt er val ) may have
an i mpact on t he subst i t ut abi l i t y of al r eady appr oved gener i c ver si ons of t hat
pr oduct t hat wer e r at ed by t he Agency as t her apeut i cal l y equi val ent t o t he
l i st ed pr oduct . When such changes i n t he l i st ed dr ug pr oduct ar e consi der ed
by t he Agency t o have a si gni f i cant i mpact on t her apeut i c equi val ence, t he
Agency wi l l change t he t her apeut i c equi val ence r at i ngs f or ot her ver si ons of
t he dr ug pr oduct unl ess t he manuf act ur er s of t hose ot her ver si ons of t he
pr oduct pr ovi de addi t i onal i nf or mat i on t o assur e equi val ence under t he changed
condi t i ons. Pendi ng r ecei pt of t he addi t i onal dat a, t he Agency may add a not e
t o Sect i on 1. 8, or , i n r ar e cases, may even change t he t her apeut i c equi val ence
r at i ng.
I n some cases ( e. g. , I sol yt eS w/ Dext r ose 5%i n Pl ast i c Cont ai ner and
Pl asma- Lyt e148 and Dext r ose 5%i n Pl ast i c Cont ai ner ) , cl osel y r el at ed
pr oduct s ar e l i st ed as cont ai ni ng t he same act i ve i ngr edi ent s, but i n somewhat
di f f er ent amount s. I n det er mi ni ng whi ch of t hese pr oduct s ar e
phar maceut i cal l y equi val ent , t he Agency has consi der ed pr oduct s t o be
xiv

















phar maceut i cal l y equi val ent wi t h l abel ed st r engt hs of an i ngr edi ent t hat do
not var y by mor e t han 1%.
Di f f er ent sal t s and est er s of t he same t her apeut i c moi et y ar e r egar ded as
phar maceut i cal al t er nat i ves. For t he pur pose of t hi s publ i cat i on, such
pr oduct s ar e not consi der ed t o be t her apeut i cal l y equi val ent . Ther e ar e no
i nst ances i n t hi s Li st wher e phar maceut i cal al t er nat i ves ar e eval uat ed or
coded wi t h r egar d t o t her apeut i c equi val ence. Anhydr ous and hydr at ed ent i t i es,
as wel l as di f f er ent pol ymor phs, ar e consi der ed phar maceut i cal equi val ent s and
must meet t he same st andar ds and, wher e necessar y, as i n t he case of
ampi ci l l i n/ ampi ci l l i n t r i hydr at e, t hei r equi val ence i s suppor t ed by
appr opr i at e bi oavai l abi l i t y/ bi oequi val ence st udi es.
The codes i n t hi s book ar e not i nt ended t o pr ecl ude heal t h car e
pr of essi onal s f r omconver t i ng phar maceut i cal l y di f f er ent concent r at i ons i nt o
phar maceut i cal equi val ent s usi ng accept ed pr of essi onal pr act i ce.
Wher e package si ze var i at i ons have t her apeut i c i mpl i cat i ons, pr oduct s so
packaged have not been consi der ed phar maceut i cal l y equi val ent . For exampl e,
some or al cont r acept i ves ar e suppl i ed i n 21- t abl et and 28- t abl et packet s; t he
28- t abl et packet s cont ai n 7 pl acebo or i r on t abl et s. These t wo packagi ng
conf i gur at i ons ar e not r egar ded as phar maceut i cal l y equi val ent ; t hus, t hey ar e
not desi gnat ed as t her apeut i cal l y equi val ent .
Pr eser vat i ves may di f f er among some t her apeut i cal l y equi val ent dr ug
pr oduct s. Di f f er ences i n pr eser vat i ves and ot her i nact i ve i ngr edi ent s do not
af f ect FDA' s eval uat i on of t her apeut i c equi val ence except i n cases wher e t hese
component s may i nf l uence bi oequi val ence or r out es of admi ni st r at i on.
The speci f i c sub- codes f or t hose dr ugs eval uat ed as t her apeut i cal l y
equi val ent and t he pol i ci es under l yi ng t hese sub- codes f ol l ow:
AA Products in conventional dosage forms not presenting bioequivalence problems
Pr oduct s coded as AA cont ai n act i ve i ngr edi ent s and dosage f or ms t hat ar e
not r egar ded as pr esent i ng ei t her act ual or pot ent i al bi oequi val ence
pr obl ems or dr ug qual i t y or st andar ds i ssues. However , al l or al dosage
f or ms must , nonet hel ess, meet an appr opr i at e in vitro bi oequi val ence
st andar d t hat i s accept abl e t o t he Agency i n or der t o be appr oved.
AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements
Mul t i sour ce dr ug pr oduct s l i st ed under t he same headi ng ( i . e. , i dent i cal
act i ve i ngr edi ent s( s) , dosage f or m, and r out e( s) of admi ni st r at i on) and
havi ng t he same st r engt h ( see Sect i on 1. 2, Therapeutic Equivalence-Related
Terms, Pharmaceutical Equivalents) gener al l y wi l l be coded AB i f a st udy
i s submi t t ed demonst r at i ng bi oequi val ence.
I n cer t ai n i nst ances, a number i s added t o t he end of t he AB code t o make
a t hr ee char act er code ( i . e. , AB1, AB2, AB3, etc.) . Thr ee- char act er codes
ar e assi gned onl y i n si t uat i ons when mor e t han one r ef er ence l i st ed dr ug
of t he same st r engt h has been desi gnat ed under t he same headi ng. Two or
mor e r ef er ence l i st ed dr ugs ar e gener al l y sel ect ed onl y when t her e ar e at
l east t wo pot ent i al r ef er ence dr ug pr oduct s whi ch ar e not bi oequi val ent t o
each ot her . I f a st udy i s submi t t ed t hat demonst r at es bi oequi val ence t o a
speci f i c l i st ed dr ug pr oduct , t he gener i c pr oduct wi l l be gi ven t he same
t hr ee- char act er code as t he r ef er ence l i st ed dr ug i t was compar ed agai nst .
For exampl e, Adal at CC ( Mi l es) and Pr ocar di a XL( Pf i zer ) , ext ended-
r el ease t abl et s, ar e l i st ed under t he act i ve i ngr edi ent ni f edi pi ne. These
dr ug pr oduct s, l i st ed under t he same headi ng, ar e not bi oequi val ent t o
each ot her . Gener i c dr ug pr oduct s deemed by FDA t o be bi oequi val ent t o
Adal at CC and Pr ocar di a XLhave been appr oved, Adal at CC and Pr ocar di a
XLhave been assi gned r at i ngs of AB1 and AB2, r espect i vel y. The gener i c
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dr ug pr oduct s bi oequi val ent t o Adal at CC woul d be assi gned a r at i ng of
AB1 and t hose bi oequi val ent t o Pr ocar di a XLwoul d be assi gned a r at i ng of
AB2. ( The assi gnment of an AB1 or AB2 r at i ng t o a speci f i c pr oduct does
not i mpl y pr oduct pr ef er ence. ) Even t hough dr ug pr oduct s of di st r i but or s
and/ or r epackager s ar e not i ncl uded i n t he Li st , t hey ar e consi der ed
t her apeut i cal l y equi val ent t o t he appl i cat i on hol der ' s dr ug pr oduct i f t he
appl i cat i on hol der ' s dr ug pr oduct i s r at ed ei t her wi t h an AB or t hr ee-
char act er code or i s si ngl e sour ce i n t he Li st . Dr ugs coded as AB under a
headi ng ar e consi der ed t her apeut i cal l y equi val ent onl y t o ot her dr ugs
coded as AB under t hat headi ng. Dr ugs coded wi t h a t hr ee- char act er code
under a headi ng ar e consi der ed t her apeut i cal l y equi val ent onl y t o ot her
dr ugs coded wi t h t he same t hr ee- char act er code under t hat headi ng.
AN Solutions and powders for aerosolization
Uncer t ai nt y r egar di ng t he t her apeut i c equi val ence of aer osol i zed pr oduct s
ar i ses pr i mar i l y because of di f f er ences i n t he dr ug del i ver y syst em.
Sol ut i ons and powder s i nt ended f or aer osol i zat i on t hat ar e mar ket ed f or
use i n any of sever al del i ver y syst ems ar e consi der ed t o be
phar maceut i cal l y and t her apeut i cal l y equi val ent and ar e coded AN. Those
pr oduct s t hat ar e compat i bl e onl y wi t h a speci f i c del i ver y syst emor t hose
pr oduct s t hat ar e packaged i n and wi t h a speci f i c del i ver y syst emar e
coded BN, unl ess t hey have met an appr opr i at e bi oequi val ence st andar d.
Sol ut i ons or suspensi ons i n a speci f i c del i ver y syst emwi l l be coded AN i f
t he bi oequi val ence st andar d i s based upon in vitro met hodol ogy, i f
bi oequi val ence needs t o be demonst r at ed by in vivo met hodol ogy t hen t he
dr ug pr oduct s wi l l be coded AB.
AO Injectable oil solutions
The absor pt i on of dr ugs i n i nj ect abl e ( par ent er al ) oi l sol ut i ons may var y
subst ant i al l y wi t h t he t ype of oi l empl oyed as a vehi cl e and t he
concent r at i on of t he act i ve i ngr edi ent . I nj ect abl e oi l sol ut i ons ar e
t her ef or e consi der ed t o be phar maceut i cal l y and t her apeut i cal l y equi val ent
onl y when t he act i ve i ngr edi ent , i t s concent r at i on, and t he t ype of oi l
used as a vehi cl e ar e al l i dent i cal .
AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous
solutions
I t shoul d be not ed t hat even t hough i nj ect abl e ( par ent er al ) pr oduct s under
a speci f i c l i st i ng may be eval uat ed as t her apeut i cal l y equi val ent , t her e
may be i mpor t ant di f f er ences among t he pr oduct s i n t he gener al cat egor y,
I nj ect abl e; I nj ect i on. For exampl e, some i nj ect abl e pr oduct s t hat ar e
r at ed t her apeut i cal l y equi val ent ar e l abel ed f or di f f er ent r out es of
admi ni st r at i on. I n addi t i on, some pr oduct s eval uat ed as t her apeut i cal l y
equi val ent may have di f f er ent pr eser vat i ves or no pr eser vat i ves at al l .
I nj ect abl e pr oduct s avai l abl e as dr y powder s f or r econst i t ut i on,
concent r at ed st er i l e sol ut i ons f or di l ut i on, or st er i l e sol ut i ons r eady
f or i nj ect i on ar e phar maceut i cal al t er nat i ve dr ug pr oduct s. They ar e not
r at ed as t her apeut i cal l y equi val ent ( AP) t o each ot her even i f t hese
phar maceut i cal al t er nat i ve dr ug pr oduct s ar e desi gned t o pr oduce t he same
concent r at i on pr i or t o i nj ect i on and ar e si mi l ar l y l abel ed. Consi st ent
wi t h accept ed pr of essi onal pr act i ce, i t i s t he r esponsi bi l i t y of t he
pr escr i ber , di spenser , or i ndi vi dual admi ni st er i ng t he pr oduct t o be
f ami l i ar wi t h a pr oduct ' s l abel i ng t o assur e t hat i t i s gi ven onl y by t he
r out e( s) of admi ni st r at i on st at ed i n t he l abel i ng.
Cer t ai n commonl y used l ar ge vol ume i nt r avenous pr oduct s i n gl ass
cont ai ner s ar e not i ncl uded on t he Li st ( e. g. , dext r ose i nj ect i on 5%,
xvi



















dext r ose i nj ect i on 10%, sodi umchl or i de i nj ect i on 0. 9%) si nce t hese
pr oduct s ar e on t he mar ket wi t hout FDA appr oval and t he FDA has not
publ i shed condi t i ons f or mar ket i ng such par ent er al pr oduct s under appr oved
NDAs. When packaged i n pl ast i c cont ai ner s, however , FDA r egul at i ons
r equi r e appr oved appl i cat i ons pr i or t o mar ket i ng. Appr oval t hen depends
on, among ot her t hi ngs, t he ext ent of t he avai l abl e saf et y dat a i nvol vi ng
t he speci f i c pl ast i c component of t he pr oduct . Al l l ar ge vol ume
par ent er al pr oduct s ar e manuf act ur ed under si mi l ar st andar ds, r egar dl ess
of whet her t hey ar e packaged i n gl ass or pl ast i c. Thus, FDA has no r eason
t o bel i eve t hat t he packagi ng cont ai ner of l ar ge vol ume par ent er al dr ug
pr oduct s t hat ar e phar maceut i cal l y equi val ent woul d have any ef f ect on
t hei r t her apeut i c equi val ence.
The st r engt h of par ent er al dr ugs pr oduct s i s def i ned as t he t ot al dr ug
cont ent of t he cont ai ner . Unt i l r ecent l y t he st r engt h of l i qui d
par ent er al dr ug pr oduct s i n t he Or ange Book have not been di spl ayed. The
concent r at i on of t he l i qui d par ent er al dr ug pr oduct i n t he Or ange Book has
been shown as xmg/ ml . The amount of dr y powder or f r eeze dr i ed powder i n
a cont ai ner has al ways been i dent i f i ed as t he st r engt h.
Wi t h t he f i nal i zat i on of t he Waxman- Hat ch amendment s t hat char act er i zed
each st r engt h of a dr ug pr oduct as a l i st ed dr ug, i t became evi dent t hat
t he f or mat of t he Or ange Book shoul d be changed t o r ef l ect each st r engt h
of a par ent er al sol ut i on. To t hi s end t he OGD has st ar t ed t o di spl ay t he
st r engt h of al l new appr oval s of par ent er al sol ut i ons. Pr evi ousl y we
woul d have di spl ayed onl y t he concent r at i on of an appr oved par ent er al
sol ut i on, e. g. 50mg/ ml . I f t hi s dr ug pr oduct had a 20 ml and 60 ml
cont ai ner appr oved t he t wo pr oduct s woul d be shown as 1Gm/ 20ml ( 50mg/ ml )
and 3Gm/ 60ml ( 50mg/ ml ) .
AT Topical products
Ther e ar e a var i et y of t opi cal dosage f or ms avai l abl e f or der mat ol ogi c,
opht hal mi c, ot i c, r ect al , and vagi nal admi ni st r at i on, i ncl udi ng cr eams,
gel s, l ot i ons, oi l s, oi nt ment s, past es, sol ut i ons, spr ays and
supposi t or i es. Even t hough di f f er ent t opi cal dosage f or ms may cont ai n t he
same act i ve i ngr edi ent and pot ency, t hese dosage f or ms ar e not consi der ed
phar maceut i cal l y equi val ent . Ther ef or e, t hey ar e not consi der ed
t her apeut i cal l y equi val ent . Al l sol ut i ons and DESI dr ug pr oduct s
cont ai ni ng t he same act i ve i ngr edi ent i n t he same t opi cal dosage f or mf or
whi ch a wai ver of in vivo bi oequi val ence has been gr ant ed and f or whi ch
chemi st r y and manuf act ur i ng pr ocesses ar e adequat e t o demonst r at e
bi oequi val ence, ar e consi der ed t her apeut i cal l y equi val ent and coded AT.
Phar maceut i cal l y equi val ent t opi cal pr oduct s t hat r ai se quest i ons of
bi oequi val ence, i ncl udi ng al l post - 1962 non- sol ut i on t opi cal dr ug
pr oduct s, ar e coded AB when suppor t ed by adequat e bi oequi val ence dat a, and
BT i n t he absence of such dat a.
" B" CODES
Drug products that FDA, at this time, considers not to be therapeutically equivalent to other
pharmaceutically equivalent products.
" B" pr oduct s, f or whi ch act ual or pot ent i al bi oequi val ence pr obl ems have
not been r esol ved by adequat e evi dence of bi oequi val ence, of t en have a pr obl em
wi t h speci f i c dosage f or ms r at her t han wi t h t he act i ve i ngr edi ent s. Dr ug
pr oduct s desi gnat ed wi t h a " B" code f al l under one of t hr ee mai n pol i ci es:
( 1) t he dr ug pr oduct s cont ai n act i ve i ngr edi ent s or ar e manuf act ur ed i n
dosage f or ms t hat have been i dent i f i ed by t he Agency as havi ng
document ed bi o- equi val ence pr obl ems or a si gni f i cant pot ent i al f or
xvii
























such pr obl ems and f or whi ch no adequat e st udi es demonst r at i ng
bi oequi val ence have been submi t t ed t o FDA; or
( 2) t he qual i t y st andar ds ar e i nadequat e or FDA has an i nsuf f i ci ent basi s
t o det er mi ne t her apeut i c equi val ence; or
( 3) t he dr ug pr oduct s ar e under r egul at or y r evi ew.
The speci f i c codi ng def i ni t i ons and pol i ci es f or t he " B" sub- codes ar e as
f ol l ows:
B* Drug products requiring further FDA investigation and review to determine therapeutic
equivalence
The code B* i s assi gned t o pr oduct s pr evi ousl y assi gned an A or B code
when FDA r ecei ves new i nf or mat i on t hat r ai ses a si gni f i cant quest i on
r egar di ng t her apeut i c equi val ence t hat can be r esol ved onl y t hr ough
f ur t her Agency i nvest i gat i on and/ or r evi ew of dat a and i nf or mat i on
submi t t ed by t he appl i cant . The B* code si gni f i es t hat t he Agency wi l l
t ake no posi t i on r egar di ng t he t her apeut i c equi val ence of t he pr oduct
unt i l t he Agency compl et es i t s i nvest i gat i on and r evi ew.
BC Extended-release dosage forms (capsules, injectables and tablets)
Ext ended- r el ease t abl et s ar e f or mul at ed i n such a manner as t o make t he
cont ai ned medi cament avai l abl e over an ext ended per i od of t i me f ol l owi ng
i ngest i on.
Al t hough bi oavai l abi l i t y st udi es have been conduct ed on t hese dosage
f or ms, t hey may be subj ect t o bi oavai l abi l i t y di f f er ences, pr i mar i l y
because f i r ms devel opi ng ext ended- r el ease pr oduct s f or t he same act i ve
i ngr edi ent r ar el y empl oy t he same f or mul at i on appr oach. FDA, t her ef or e,
does not consi der di f f er ent ext ended- r el ease dosage f or ms cont ai ni ng t he
same act i ve i ngr edi ent i n equal st r engt h t o be t her apeut i cal l y equi val ent
unl ess equi val ence bet ween i ndi vi dual pr oduct s i n bot h r at e and ext ent has
been speci f i cal l y demonst r at ed t hr ough appr opr i at e bi oequi val ence st udi es.
Ext ended- r el ease pr oduct s f or whi ch such bi oequi val ence dat a have not been
submi t t ed ar e coded BC, whi l e t hose f or whi ch such dat a ar e avai l abl e have
been coded AB.
BD Active ingredients and dosage forms with documented bioequivalence problems
The BD code denot es pr oduct s cont ai ni ng act i ve i ngr edi ent s wi t h known
bi oequi val ence pr obl ems and f or whi ch adequat e st udi es have not been
submi t t ed t o FDA demonst r at i ng bi oequi val ence. Wher e st udi es showi ng
bi oequi val ence have been submi t t ed, t he pr oduct has been coded AB.
BE Delayed-release oral dosage forms
Wher e t he dr ug may be dest r oyed or i nact i vat ed by t he gast r i c j ui ce or
wher e i t may i r r i t at e t he gast r i c mucosa, t he use of ent er i c coat i ngs i s
i ndi cat ed. Such coat i ngs ar e i nt ended t o del ay t he r el ease of t he
medi cat i on unt i l t he t abl et has passed t hr ough t he st omach. Dr ug pr oduct s
i n del ayed- r el ease dosage f or ms cont ai ni ng t he same act i ve i ngr edi ent s ar e
subj ect t o si gni f i cant di f f er ences i n absor pt i on. Unl ess ot her wi se
speci f i cal l y not ed, t he Agency consi der s di f f er ent del ayed- r el ease
pr oduct s cont ai ni ng t he same act i ve i ngr edi ent s as pr esent i ng a pot ent i al
bi oequi val ence pr obl emand codes t hese pr oduct s BE i n t he absence of
in vivo st udi es showi ng bi oequi val ence. I f adequat e in vivo st udi es have
xviii




















demonst r at ed t he bi oequi val ence of speci f i c del ayed- r el ease pr oduct s, such
pr oduct s ar e coded AB.
BN Products in aerosol-nebulizer drug delivery systems
Thi s code appl i es t o dr ug sol ut i ons or powder s t hat ar e mar ket ed onl y as a
component of , or as compat i bl e wi t h, a speci f i c dr ug del i ver y syst em.
Ther e may, f or exampl e, be si gni f i cant di f f er ences i n t he dose of dr ug and
par t i cl e si ze del i ver ed by di f f er ent pr oduct s of t hi s t ype. Ther ef or e,
t he Agency does not consi der di f f er ent met er ed aer osol dosage f or ms
cont ai ni ng t he same act i ve i ngr edi ent ( s) i n equal st r engt hs t o be
t her apeut i cal l y equi val ent unl ess t he dr ug pr oduct s meet an appr opr i at e
bi oequi val ence st andar d, such pr oduct s ar e coded AB.
BP Active ingredients and dosage forms with potential bioequivalence problems
FDA' s bi oequi val ence r egul at i ons ( 21 CFR 320. 33) cont ai n cr i t er i a and
pr ocedur es f or det er mi ni ng whet her a speci f i c act i ve i ngr edi ent i n a
speci f i c dosage f or mhas a pot ent i al f or causi ng a bi oequi val ence pr obl em.
I t i s FDA' s pol i cy t o consi der an i ngr edi ent meet i ng t hese cr i t er i a as
havi ng a pot ent i al bi oequi val ence pr obl emeven i n t he absence of posi t i ve
dat a demonst r at i ng i nequi val ence. Phar maceut i cal l y equi val ent pr oduct s
cont ai ni ng t hese i ngr edi ent s i n or al dosage f or ms ar e coded BP unt i l
adequat e in vivo bi oequi val ence dat a ar e submi t t ed, such pr oduct s ar e
coded AB. I nj ect abl e suspensi ons cont ai ni ng an act i ve i ngr edi ent
suspended i n an aqueous or ol eagi nous vehi cl e have al so been coded BP.
I nj ect abl e suspensi ons ar e subj ect t o bi oequi val ence pr obl ems because
di f f er ences i n par t i cl e si ze, pol ymor phi c st r uct ur e of t he suspended
act i ve i ngr edi ent , or t he suspensi on f or mul at i on can si gni f i cant l y af f ect
t he r at e of r el ease and absor pt i on. FDA does not consi der phar maceut i cal
equi val ent s of t hese pr oduct s bi oequi val ent wi t hout adequat e evi dence of
bi oequi val ence, such pr oduct s woul d be coded AB.
BR Suppositories or enemas that deliver drugs for systemic absorption
The absor pt i on of act i ve i ngr edi ent s f r omsupposi t or i es or enemas t hat ar e
i nt ended t o have a syst emi c ef f ect ( as di st i nct f r omsupposi t or i es
admi ni st er ed f or l ocal ef f ect ) can var y si gni f i cant l y f r ompr oduct t o
pr oduct . Ther ef or e, FDA consi der s phar maceut i cal l y equi val ent syst emi c
supposi t or i es or enemas bi o- equi val ent onl y i f in vivo evi dence of
bi oequi val ence i s avai l abl e. I n t hose cases wher e in vivo evi dence i s
avai l abl e, t he pr oduct i s coded AB. I f such evi dence i s not avai l abl e,
t he pr oduct s ar e coded BR.
BS Products having drug standard deficiencies
I f t he dr ug st andar ds f or an act i ve i ngr edi ent i n a par t i cul ar dosage f or m
ar e f ound by FDA t o be def i ci ent so as t o pr event an FDA eval uat i on of
ei t her phar maceut i cal or t her apeut i c equi val ence, al l dr ug pr oduct s
cont ai ni ng t hat act i ve i ngr edi ent i n t hat dosage f or mar e coded BS. For
exampl e, i f t he st andar ds per mi t a wi de var i at i on i n phar macol ogi cal l y
act i ve component s of t he act i ve i ngr edi ent such t hat phar maceut i cal
equi val ence i s i n quest i on, al l pr oduct s cont ai ni ng t hat act i ve i ngr edi ent
i n t hat dosage f or mar e coded BS.
xix



















BT Topical products with bioequivalence issues
Thi s code appl i es mai nl y t o post - 1962 der mat ol ogi c, opht hal mi c, ot i c,
r ect al , and vagi nal pr oduct s f or t opi cal admi ni st r at i on, i ncl udi ng cr eams,
oi nt ment s, gel s, l ot i ons, past es, and spr ays, as wel l as supposi t or i es not
i nt ended f or syst emi c dr ug absor pt i on. Topi cal pr oduct s eval uat ed as
havi ng accept abl e cl i ni cal per f or mance, but t hat ar e not bi oequi val ent t o
ot her phar maceut i cal l y equi val ent pr oduct s or t hat l ack suf f i ci ent
evi dence of bi oequi val ence, wi l l be coded BT.
BX Drug products for which the data are insufficient to determine therapeutic equivalence
The code BX i s assi gned t o speci f i c dr ug pr oduct s f or whi ch t he dat a t hat
have been r evi ewed by t he Agency ar e i nsuf f i ci ent t o det er mi ne t her apeut i c
equi val ence under t he pol i ci es st at ed i n t hi s document . I n t hese
si t uat i ons, t he dr ug pr oduct s ar e pr esumed t o be t her apeut i cal l y
i nequi val ent unt i l t he Agency has det er mi ned t hat t her e i s adequat e
i nf or mat i on t o make a f ul l eval uat i on of t her apeut i c equi val ence.
1.8 Description of Special Situations
Cer t ai n dr ugs l i st ed i n t he Or ange Book pr esent speci al si t uat i ons t hat
mer i t f ur t her di scussi on. Fol l owi ng i s a descr i pt i on of t hose speci al
si t uat i ons:
Amino Acid and Protein Hydrolysate Injections. These pr oduct s di f f er i n
t he amount and ki nds of ami no aci ds t hey cont ai n and, t her ef or e, ar e not
consi der ed phar maceut i cal equi val ent s. For t hi s r eason, t hese pr oduct s ar e
not consi der ed t her apeut i cal l y equi val ent . At t he same t i me, t he Agency
bel i eves t hat i t i s appr opr i at e t o poi nt out t hat wher e ni t r ogen bal ance i s
t he sol e t her apeut i c obj ect i ve and i ndi vi dual ami no aci d cont ent i s not a
consi der at i on, phar maceut i cal al t er nat i ves wi t h t he same t ot al amount of
ni t r ogen cont ent may be consi der ed t her apeut i cal l y equi val ent .
Follitropin Alfa and Beta. Based on avai l abl e dat a der i ved f r omphysi co-
chemi cal t est s and bi oassay, f ol l i t r opi n al f a and f ol l i t r opi n bet a ar e
i ndi st i ngui shabl e.
Gaviscon. Gavi sconi s an OTC pr oduct whi ch has been mar ket ed si nce
Sept ember 1970. The act i ve i ngr edi ent s i n t hi s pr oduct , al umi numhydr oxi de
and magnesi umt r i si l i cat e, wer e r evi ewed by t he Agency' s OTC Ant aci d Panel and
wer e consi der ed t o be saf e and ef f ect i ve i ngr edi ent s ( Cat egor y I ) by t hat
Panel . However , t he t abl et f ai l ed t o pass t he ant aci d t est whi ch i s r equi r ed
of al l ant aci d pr oduct s. The Agency, t her ef or e, pl aced t he t abl et i n Cat egor y
I I I f or l ack of ef f ect i veness. A f ul l NDA wi t h cl i ni cal st udi es was submi t t ed
by Mar i on Labor at or i es, I nc. , and appr oved by FDA on December 9, 1983.
Gavi scon s act i vi t y i n t r eat i ng r ef l ux aci di t y i s made possi bl e by t he
physi cal - chemi cal pr oper t i es of t he i nact i ve i ngr edi ent s, sodi umbi car bonat e
and al gi ni c aci d. Ther ef or e, all ANDAs which cite Gaviscon tablets as the
listed drug must contain the inactive ingredients sodium bicarbonate and
alginic acid. A f ul l NDA wi l l be r equi r ed t o suppor t t he ef f ect i veness of t he
dr ug pr oduct i f di f f er ent i nact i ve i ngr edi ent s ar e t o be subst i t ut ed f or
sodi umbi car bonat e or al gi ni c aci d or i f di f f er ent pr opor t i ons of t hese
i ngr edi ent s ar e t o be used.
Levothyroxine Sodium. Because t her e ar e mul t i pl e r ef er ence l i st ed dr ugs
of l evot hyr oxi ne sodi umt abl et s and some r ef er ence l i st ed dr ugs' sponsor s have
conduct ed st udi es t o est abl i sh t hei r dr ugs' t her apeut i c equi val ence t o ot her
r ef er ence l i st ed dr ugs, FDA has det er mi ned t hat i t s usual pr act i ce of
assi gni ng t wo or t hr ee char act er TE codes may be pot ent i al l y conf usi ng and
i nadequat e f or t hese dr ug pr oduct s. Accor di ngl y, FDA pr ovi des t he f ol l owi ng
expl anat i on and char t of t her apeut i c equi val ence eval uat i ons f or l evot hyr oxi ne
xx































sodi umdr ug pr oduct s.
Levot hyr oxi ne Sodi um( Myl an ANDA 76187) t abl et s have been det er mi ned t o be
t her apeut i cal l y equi val ent t o cor r espondi ng st r engt hs of Uni t hr oi d ( J er ome
St evens NDA 021210) t abl et s.
Levo- T ( Al ar a NDA 021342) , Levot hyr oxi ne Sodi um( Myl an ANDA 76187) , Uni t hr oi d
( J er ome St evens NDA 021210) , and Levot hyr oxi ne Sodi um( Mer ck KGAA ANDA
76752) t abl et s have been det er mi ned t o be t her apeut i cal l y equi val ent t o
cor r espondi ng st r engt hs of Synt hr oi d ( Abbot t NDA 021402) t abl et s.
Levo- T ( Al ar a NDA 021342) , Uni t hr oi d ( J er ome St evens NDA 021210) ,
Levot hyr oxi ne Sodi um( Myl an ANDA 076187) , and Levot hyr oxi ne Sodi um( Mer ck KGAA
ANDA 76752) t abl et s have been det er mi ned t o be t her apeut i cal l y equi val ent t o
cor r espondi ng st r engt hs of Levoxyl ( Ki ng Phar ms NDA 021301) t abl et s.
Levot hyr oxi ne Sodi um( Myl an ANDA 76187) t abl et s have been det er mi ned t o be
t her apeut i cal l y equi val ent t o cor r espondi ng st r engt hs of Levot hr oi d ( Ll oyd NDA
021116) t abl et s.
The char t out l i nes TE codes f or al l 0. 025mg pr oduct s. Ot her pr oduct st r engt hs
may be si mi l ar . Ther apeut i c equi val ence has been est abl i shed bet ween pr oduct s
t hat have t he same AB+number TE code. Mor e t han one TE code may appl y t o some
pr oduct s. One common TE code i ndi cat es t her apeut i c equi val ence bet ween
pr oduct s.
Tr ade Name Appl i cant Pot ency
TE
Code
Appl
No
Pr oduct
No
UNI THROI D STEVENS J 0. 025MG AB1 021210 001
LEVOTHYROXI NE SODI UM MYLAN 0. 025MG AB1 076187 001
LEVOXYL KI NG PHARMS 0. 025MG AB1 021301 001
SYNTHROI D ABBOTT 0. 025MG AB1 021402 001
LEVO- T ALARA PHARM 0. 025MG AB1 021342 001
SYNTHROI D ABBOTT 0. 025MG AB2 021402 001
LEVOTHYROXI NE SODI UM MYLAN 0. 025MG AB2 076187 001
LEVO- T ALARA PHARM 0. 025MG AB2 021342 001
UNI THROI D STEVENS J 0. 025MG AB2 021210 001
LEVOXYL KI NG PHARMS 0. 025MG AB3 021301 001
LEVO- T ALARA PHARM 0. 025MG AB3 021342 001
UNI THROI D STEVENS J 0. 025MG AB3 021210 001
LEVOTHYROXI NE SODI UM MYLAN 0. 025MG AB3 076187 001
LEVOTHROI D LLOYD 0. 025MG AB4 021116 001
LEVOTHYROXI NE SODI UM MYLAN 0. 025MG AB4 076187 001
Patent Certification(s) Reference Listed Drug based upon a suitability
petition. An abbr evi at ed new dr ug appl i cat i on t hat r ef er s t o a Ref er ence
Li st ed Dr ug ( RLD) appr oved pur suant t o a sui t abi l i t y pet i t i on must demonst r at e
t hat t he pr oposed pr oduct i s bi oequi val ent t o t he RLD, and i t must i ncl ude
appr opr i at e pat ent cer t i f i cat i on( s) and an excl usi vi t y st at ement wi t h r espect
t o t he l i st ed dr ug whi ch ser ved as t he basi s f or t he appr oved sui t abi l i t y
pet i t i on. Thi s concept al so appl i es t o an ANDA appl i cant t hat ci t es a RLD
t hat was based upon an NDA t hat i s st i l l cover ed by pat ent ( s) and/ or
excl usi vi t y, e. g. a second RLD t hat was sel ect ed when t he i n vi vo
det er mi nat i on of bi oequi val ence of t he or i gi nal RLD i s sel f evi dent and t he
wai ver of t he i n vi vo det er mi nat i on of bi oequi val ence may be gr ant ed.
xxi
















Waived exclusivity. I f a new dr ug appl i cat i on ( NDA) submi t t ed under
sect i on 505( b) of t he Feder al Food, Dr ug, and Cosmet i c Act ( Act ) qual i f i es f or
excl usi vi t y under sect i ons 505( c) ( 3) ( D) and 505( j ) ( 5) ( D) , t he excl usi vi t y i s
l i st ed i n t he Pat ent and Excl usi vi t y Sect i on of t he Or ange Book. I f a dr ug
pr oduct has r ecei ved t hi s excl usi vi t y, t he FDA wi l l del ay t he appr oval of a
505( b) ( 2) appl i cat i on or an abbr evi at ed new dr ug appl i cat i on ( ANDA) under
sect i on 505( j ) of t he Act unt i l t he expi r at i on of t he excl usi vi t y. I f t he
l i st ed dr ug i s al so pr ot ect ed by one or mor e pat ent s, t he appr oval dat e f or
t he 505( b) ( 2) appl i cat i on or ANDA wi l l be det er mi ned by t he l at est expi r i ng
pat ent or excl usi vi t y l i st ed i n t he Or ange Book. However , t he hol der of t he
NDA may wai ver i t s excl usi vi t y as t o any or al l 505( b) ( 2) and ANDA
appl i cat i ons r ef er enci ng t he pr ot ect ed dr ug pr oduct . I f an NDA sponsor
wai ver s i t s r i ght t o t he excl usi vi t y pr ot ect i on, qual i f i ed 505( b) ( 2) or ANDA
appl i cat i ons may be appr oved wi t hout r egar d t o t he NDA hol der ' s excl usi vi t y.
An NDA f or whi ch t he hol der has wai ved i t s excl usi vi t y as t o al l 505( b) ( 2) and
ANDA appl i cat i ons wi l l be coded wi t h a Wi n t he Pat ent and Excl usi vi t y Sect i on
of t he Or ange Book and be r ef er r ed t o t hi s sect i on. The appl i cant r ef er enci ng
t hi s l i st ed dr ug shoul d i ndi cat e i n t he excl usi vi t y st at ement t hat t he hol der
of t he l i st ed dr ug has wai ved i t s excl usi vi t y.
1.9 Therapeutic Equivalence Code Change for a Drug Entity
The Agency wi l l use t he f ol l owi ng pr ocedur es when, i n r esponse t o a
pet i t i on or on i t s own i ni t i at i ve, i t i s consi der i ng a change i n t he
t her apeut i c equi val ence code f or appr oved mul t i - sour ce dr ug pr oduct s. Such
changes wi l l gener al l y occur when t he Agency becomes awar e of new sci ent i f i c
i nf or mat i on af f ect i ng t he t her apeut i c equi val ence of an ent i r e cat egor y of
dr ug pr oduct s i n t he Li st ( e. g. , i nf or mat i on concer ni ng t he act i ve i ngr edi ent
or t he dosage f or m) , r at her t han i nf or mat i on concer ni ng a si ngl e dr ug pr oduct
wi t hi n t he cat egor y. These pr ocedur es wi l l be used when a change i n
t her apeut i c equi val ence code i s under consi der at i on f or al l dr ug pr oduct s
f ound i n t he Pr escr i pt i on Dr ug Pr oduct Li st under a speci f i c dr ug ent i t y and
dosage f or m. The change may be f r omt he code si gni f yi ng t hat t he dr ug does
not pr esent a bi oequi val ence pr obl em( e. g. , AA) t o a code si gni f yi ng a
bi oequi val ence pr obl em( e. g. , BP) , or vi ce ver sa. Thi s pr ocedur e does not
appl y t o a change of a par t i cul ar pr oduct code ( e. g. , a change f r omBP t o AB
or f r omAB t o BX) .
Bef or e maki ng a change i n a t her apeut i c equi val ence code f or an ent i r e
cat egor y of dr ugs, t he Agency wi l l announce i n t he Introduction t o t he
Cumul at i ve Suppl ement t hat i t i s consi der i ng t he change and wi l l i nvi t e
comment . Comment s, al ong wi t h sci ent i f i c dat a, may be sent t o t he Di r ect or ,
Di vi si on of Bi oequi val ence, Of f i ce of Gener i c Dr ugs, Cent er f or Dr ug
Eval uat i on and Resear ch, HFD- 650, 7620 St andi sh Pl ace, Rockvi l l e, MD 20855.
The comment per i od wi l l gener al l y be 60 days i n l engt h, and t he cl osi ng
dat e f or comment s wi l l be l i st ed i n t he descr i pt i on of t he pr oposed change f or
each dr ug ent i t y.
The most usef ul t ype of sci ent i f i c dat a submi ssi on i s an in vivo
bi oavai l abi l i t y/ bi oequi val ence st udy conduct ed on bat ches of t he subj ect dr ug
pr oduct s. These submi ssi ons shoul d pr esent a f ul l descr i pt i on of t he
anal yt i cal pr ocedur es and equi pment used, a val i dat i on of t he anal yt i cal
met hodol ogy, i ncl udi ng t he st andar d cur ve, a descr i pt i on of t he met hod of
cal cul at i ng r esul t s, and a descr i pt i on of t he phar macoki net i c and st at i st i cal
model s used i n anal yzi ng t he dat a. Anecdot al or t est i moni al i nf or mat i on i s
t he l east usef ul t o t he Agency, and such submi ssi ons ar e di scour aged. Copi es
of suppor t i ng r epor t s publ i shed i n t he sci ent i f i c l i t er at ur e or unpubl i shed
mat er i al , however , ar e wel come.
xxii





















1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product
The af or ement i oned pr ocedur e does not appl y t o a change i n a si ngl e dr ug
pr oduct code. For exampl e, a change i n a si ngl e dr ug pr oduct ' s code f r omBP
t o AB as a r esul t of t he submi ssi on of an accept abl e bi oequi val ence st udy
or di nar i l y wi l l not be t he subj ect of not i ce and comment . Li kewi se, a change
i n a si ngl e dr ug pr oduct ' s code f r omAB t o BX ( e. g. , as a r esul t of new
i nf or mat i on r ai si ng a si gni f i cant quest i on as t o bi oequi val ence) does not
r equi r e not i ce and comment . The Agency' s r esponsi bi l i t y t o pr ovi de t he publ i c
wi t h t he Agency' s most cur r ent i nf or mat i on r el at ed t o t her apeut i c equi val ence
may r equi r e a change i n a dr ug pr oduct ' s code pr i or t o any f or mal not i ce and
oppor t uni t y f or t he appl i cant t o be hear d. The publ i cat i on i n t he Federal
Register of a pr oposal t o wi t hdr aw appr oval of a dr ug pr oduct wi l l or di nar i l y
r esul t i n a change i n a pr oduct ' s code f r omAB t o BX i f t hi s act i on has not
al r eady been t aken.
1.11 Discontinued Section
Those dr ug pr oduct s i n t he Di scont i nued Sect i on of t he Or ange Book i n
whi ch a det er mi nat i on has al r eady been made t hat t he pr oduct s wer e not
wi t hdr awn f or saf et y or ef f i cacy r easons have **Feder al Regi st er
det er mi nat i on t hat pr oduct was not di scont i nued or wi t hdr awn f or saf et y or
ef f i cacy r easons** f ol l owi ng t he pr oduct st r engt h. Those dr ug pr oduct s ar e
onl y r ef l ect i ve of ci t i zen pet i t i ons det er mi nat i ons made si nce 1995. The
i dent i f i cat i on of t hese dr ug pr oduct s i n t he Di scont i nued Sect i on of t he
Or ange Book shoul d avoi d t he submi ssi on of mul t i pl e ci t i zen pet i t i ons f or t he
same dr ug pr oduct . FR not i ces no l onger appl i cabl e ar e r emoved f r omt he Annual
Edi t i on ( i . e. , t her e i s a cur r ent l y mar ket ed Ref er ence Li st ed Dr ug and no
appl i cabl e pat ent or excl usi vi t y) . FR Saf et y or Ef f ect i veness Det er mi nat i ons
Li st l i st s pr oduct s t hat have cur r ent and r emoved not i ces. The l i st i s
updat ed quar t er l y. Not i ces i ssued dur i ng t he year ar e added t o t he El ect r oni c
Or ange Book Quer y i n t he mont h t hey become ef f ect i ve.
Gener al l y, appr oved pr oduct s ar e added t o t he Di scont i nued Sect i on of t he
Or ange Book when t he appl i cant hol der not i f i es t he Or ange Book st af f of t he
pr oduct s not mar ket ed st at us. Pr oduct s may al so be added i f annual r epor t s
i ndi cat e t he pr oduct i s no l onger mar ket ed or ot her Agency admi ni st r at i ve
act i on ( e. g. , Wi t hdr awal of an Appl i cat i on) . Changes t o t he Or ange Book ar e
not af f ect ed by t he dr ug r egi st r at i on and l i st i ng r equi r ement s of Sect i on 510
of t he Act .
1.12 Changes to the Orange Book
Ever y ef f or t i s made t o ensur e t he Annual Edi t i on i s cur r ent and
accur at e. Appl i cant hol der s ar e r equest ed t o i nf or mt he FDA Or ange Book St af f
( OBS) of any changes or cor r ect i ons. Pl ease i nf or mt he OBS when pr oduct s ar e
no l onger mar ket ed. Not i f i cat i on of t he Or ange Book st af f t o i ncl ude t he
newl y appr oved pr oduct i n t he Di scont i nued Dr ug Pr oduct Li st r at her t han par t s
1, 2 or 3 of t he Li st ( as di scussed i n Sect i on 1. 1) must occur by t he end of
t he mont h i n whi ch t he pr oduct i s appr oved t o ensur e t hat t he pr oduct i s not
i ncl uded i n t he act i ve por t i ons of t he next publ i shed Or ange Book updat e
We can be cont act ed by emai l at dr ugpr oduct s@f da. hhs. gov. Send Changes by
FAX: 240- 276- 8974; mai l t o:
FDA/ CDER Or ange Book St af f
Of f i ce of Gener i c Dr ugs, HFD- 610
7620 St andi sh Pl ace
Rockvi l l e, MD 20855
xxiii





1.13 Availability of the Edition
Commenci ng wi t h t he 25
t h
edi t i on, t he Annual Edi t i on and cur r ent mont hl y
Cumul at i ve Suppl ement ar e avai l abl e i n a Por t abl e Document For mat ( PDF) at t he
EOB home page, El ect r oni c Or ange Book Quer y, by cl i cki ng on Publ i cat i ons. The
PDF annual f or mat dupl i cat es pr evi ous paper ver si ons except f or t he Or phan
Pr oduct s Desi gnat i ons and Appr oval s Li st . An annual subscr i pt i on of t he PDF
f or mat may be obt ai ned f r omt he U. S. Gover nment Pr i nt i ng Of f i ce, 866- 512- 1800.
xxiv














2. HOW TO USE THE DRUG PRODUCT LISTS
2.1 Key Sections for Using the Drug Product Lists
Thi s publ i cat i on cont ai ns i l l ust r at i ons, al ong wi t h Dr ug Pr oduct Li st s,
i ndi ces, and l i st s of abbr evi at i ons and t er ms whi ch f aci l i t at e t hei r use.
Illustrations. The annot at ed Drug Product Illustration, see Sect i on
2. 2, and t he Therapeutic Equivalence Evaluations Illustration, see
Sect i on 2. 3, ar e of f er ed t o pr ovi de f ur t her cl ar i f i cat i on. These depi ct t he
f or mat f ound i n t he Pr escr i pt i on Dr ug Pr oduct Li st ( t he onl y l i st i n whi ch
t her apeut i c equi val ence eval uat i on codes ar e di spl ayed) .
Drug Product Lists. The Pr escr i pt i on and OTC Dr ug Pr oduct Li st s,
ar r anged al phabet i cal l y by act i ve i ngr edi ent ( s) , cont ai n pr oduct
i dent i f i cat i on i nf or mat i on ( act i ve i ngr edi ent s, dosage f or ms, r out es of
admi ni st r at i on, pr oduct names, appl i cat i on hol der s, st r engt hs) f or si ngl e and
mul t i pl e i ngr edi ent dr ug pr oduct s. Al so shown ar e t he appl i cat i on number and
dr ug pr oduct number ( FDA i nt er nal comput er dat a use onl y) and appr oval dat es
f or t hose dr ug pr oduct s appr oved on or af t er J anuar y 1, 1982. Theapplication
numberprecededbyNisaNewDrugApplication(NDAorcommonlythe
innovator).TheapplicationnumberprecededbyanAisanAbbreviatedNew
DrugApplication(ANDAorcommonlythegeneric).
The Di scont i nued Pr oduct Li st , ar r anged al phabet i cal l y by act i ve
i ngr edi ent ( s) , cont ai ns pr oduct i dent i f i cat i on i nf or mat i on ( dosage f or m,
pr oduct name, st r engt h, and appl i cat i on number ) .
I f a pr escr i pt i on dr ug pr oduct i s avai l abl e f r ommor e t han one sour ce
( mul t i sour ce) , a t her apeut i c equi val ence code wi l l appear i n f r ont of t he
appl i cant ' s name. I f a pr oduct i s t her apeut i cal l y equi val ent t o one or mor e
pr oduct s or t o an appr opr i at e r ef er ence, i t wi l l be desi gnat ed wi t h a code
begi nni ng wi t h " A" and t he ent r y wi l l be under l i ned and pr i nt ed i n bol d f ont
f or emphasi s.
Act i ve i ngr edi ent headi ngs f or mul t i pl e i ngr edi ent ( combi nat i on) dr ug
pr oduct s ar e ar r anged al phabet i cal l y. For pur poses of t hi s publ i cat i on, t hi s
al phabet i cal sor t t akes pr ecedence over Uni t ed St at es Phar macopei a of f i ci al
monogr aph or der ( i . e. , Reser pi ne, Hydr al azi ne Hydr ochl or i de,
Hydr ochl or ot hi azi de) . For exampl e, pr oduct i nf or mat i on l abel ed as Reser pi ne,
Hydr ochl or ot hi azi de and Hydr al azi ne Hydr ochl or i de appear s under t he act i ve
i ngr edi ent headi ng Hydralazine Hydrochloride; Hydrochlorothiazide; Reserpine.
A cr oss- r ef er ence t o t he pr oduct i nf or mat i on ( f or pr escr i pt i on and OTC
pr oduct s) appear s f or each addi t i onal act i ve i ngr edi ent i n t he pr oduct . For
combi nat i on dr ug pr oduct s, t he i ngr edi ent st r engt hs ar e separ at ed by
semi col ons and appear i n t he same r el at i ve sequence as t he i ngr edi ent s i n t he
headi ng. Avai l abl e st r engt hs of t he dosage f or mf r oman appl i cant appear on
separ at e l i nes.
To use t he Dr ug Pr oduct Li st s, det er mi ne by al phabet i cal or der t he
i ngr edi ent under whi ch t he pr oduct i nf or mat i on i s l i st ed, usi ng t he Pr oduct
Name I ndex, i f necessar y. Then, f i nd t he i ngr edi ent i n t he appl i cabl e Dr ug
Pr oduct Li st . Pr oceed t o t he dosage f or mand r out e of admi ni st r at i on and
compar e pr oduct s wi t hi n t hat i ngr edi ent headi ng onl y. Ther apeut i c equi val ence
or i nequi val ence f or pr escr i pt i on pr oduct s i s det er mi ned on t he basi s of t he
t her apeut i c equi val ence codes pr ovi ded wi t hi n t hat speci f i c dosage f or mand
r out e headi ng. The OTC Dr ug Pr oduct Li st , Di scont i nued Dr ug Pr oduct Li st , and
2-1










Dr ug Pr oduct s wi t h Appr oval under Sect i on 505 of t he Act Admi ni st er ed by t he
Cent er f or Bi ol ogi cs Eval uat i on and Resear ch Li st have t hei r dat a ar r anged
si mi l ar l y.
The Di scont i nued Dr ug Pr oduct Li st cont ai ns appr oved pr oduct s t hat have
never been mar ket ed, have been di scont i nued f r ommar ket i ng, ar e f or mi l i t ar y
use, or have had t hei r appr oval s wi t hdr awn f or ot her t han saf et y or ef f i cacy
r easons subsequent t o bei ng di scont i nued f r ommar ket i ng. Al l pr oduct s havi ng
a " @" i n t he 12t h Cumul at i ve Suppl ement of t he 33
r d
Edi t i on Li st have been
added t o t he Di scont i nued Dr ug Pr oduct Li st appear i ng i n t he 34
t h
Edi t i on. I n
addi t i on, appr oved dr ug pr oduct s t hat ar e not i n t he commer ci al di st r i but i on
channel e. g. , appr oved dr ug pr oduct s i n appl i cat i ons f or expor t onl y ar e al so
l i st ed i n t he Di scont i nued Sect i on of t he Or ange Book.
Product Name Index (Prescription and OTC Drug Product Lists). Thi s i s an
i ndex of dr ug pr oduct s by est abl i shed or t r ade name. The second t er mof each
ent r y i ndi cat es t he act i ve i ngr edi ent name under whi ch pr oduct i nf or mat i on can
be f ound i n t he appr opr i at e Dr ug Pr oduct Li st . For t hose dr ug pr oduct s wi t h
mul t i pl e act i ve i ngr edi ent s, onl y t he f i r st act i ve i ngr edi ent ( i n al phabet i cal
or der ) wi l l appear . OTC pr oduct s ar e so desi gnat ed.
Product Name Index Listed by Applicant (Prescription and OTC Drug
Product Lists) . Thi s i s an i ndex t hat cr oss- r ef er ences appl i cant s t o dr ug
pr oduct s. The bol ded and under l i ned ent r y r epr esent s t he appl i cant name
abbr evi at i on used i n t hi s publ i cat i on. Each compl et e appl i cant name t hat i s
r epr esent ed by t he abbr evi at ed name i s mar ked wi t h an ast er i sk ( *) . Li st ed
under each compl et e appl i cant name i s t he f i r st al phabet i cal l y ar r anged
i ngr edi ent under whi ch pr oduct i nf or mat i on can be f ound i n t he appr opr i at e
Dr ug Pr oduct Li st . OTC pr oduct s ar e so desi gnat ed. To use t he Dr ug Pr oduct
Li st s, det er mi ne by al phabet i cal or der t he i ngr edi ent under whi ch t he pr oduct
i nf or mat i on i s l i st ed, usi ng t he Pr oduct Name I ndex, i f appr opr i at e.
Uniform Terms. To i mpr ove r eadabi l i t y, uni f or mt er ms ar e used t o
desi gnat e dosage f or ms, r out es of admi ni st r at i on, and abbr evi at i ons used t o
expr ess st r engt hs. These t er ms ar e l i st ed i n Appendi x C. I n some cases, t he
t er ms used may di f f er f r omt hose used i n pr oduct l abel s and ot her l abel i ng.
2-2









































2. 2 DRUG PRODUCT I LLUSTRATI ON
SINGLE INGREDIENT
ACTI VE I NGREDI ENT MEPERI DI NE HYDROCHLORI DE
DOSAGE FORM; ROUTE OF ADMI NI STRATI ON I NJ ECTABLE; I NJ ECTI ON
HEXANON
TRADE OR GENERI C NAMES
AP + PAGE PHARMA 25MG/ML N013111 001 AUG 22, 1983
AP + 50MG/ML N013111 002 AUG 22, 1983
REFERENCE LI STED DRUG AP + 75MG/ML N013111 003 AUG 22, 1983
AP + 100MG/ML N013111 004 J AN 04, 1989
MEPERIDINE HCL
AP GREENBERG PHARM 25MG/ML A064890 001 FEB 29, 1987
THERAPEUTI C EQUI VALENCE ( TE) AP 50MG/ML A064890 002 FEB 29, 1987
CODE FOR MULTI SOURCE PRODUCT AP 75MG/ML A064890 003 FEB 29, 1987
AP 100MG/ML A064890 004 MAR 08, 1992
SI NGLE SOURCE PRODUCT ( NO TE CODE) MI N LLC 10MG/ ML A099225 001 DEC 12, 1995
AP J OHNSON MED 25MG/ML A099226 001 NOV 27, 1993
KENDRA PHARM 150MG/ ML A079444 001 OCT 31, 1999
APPLI CANT
AVAI LABLE STRENGTH( S) OF A PRODUCT
APPLI CATI ON NUMBER AND PRODUCT NUMBER
PRODUCT NUMBER I S FOR FDA I NTERNAL COMPUTER DATA USE ONLY
APPROVAL DATE
MULTIPLE INGREDIENTS WITH PRODUCT INFORMATION
ALPHABETI CALLY SORTED BY
ACTI VE I NGREDI ENT HYDRALAZI NE HYDROCHLORI DE; HYDROCHLOROTHI AZI DE; RESERPI NE
TABLET; ORAL
PRODUCT I NFORMATI ON HYDROCHLOROTHI AZI DE, RESERPI NE AND HYDRALAZI NE HCL
REI NWALD 25MG; 15MG; 0. 1MG A069808 001 J AN 18, 1982
THI S EXAMPLE I S FOR PURPOSE OF I LLUSTRATI ON ONLY. I T DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE
PRESCRI PTI ON DRUG PRODUCT LI ST.












































2. 3 THERAPEUTI C EQUI VALENCE EVALUATI ONS I LLUSTRATI ON
DRUG PRODUCTS CODED AB ( OR ANY CODE BEGI NNI NG WI TH AN "A") UNDER AN I NGREDI ENT AND DOSAGE FORM HEADI NG
ARE CONSI DERED THERAPEUTI CALLY EQUI VALENT ONLY TO OTHER PRODUCTS CODED AB ( OR ANY CODE BEGI NNI NG WI TH AN
A") AND NOT TO THOSE CODED BP ( OR ANY CODE BEGI NNI NG WI TH "B") AND ANY PRODUCTS NOT LI STED. DRUG
PRODUCTS CODED BP ( OR ANY CODE BEGI NNI NG WI TH A "B") ARE NOT CONSI DERED THERAPEUTI CALLY EQUI VALENT TO
ANY OTHER PRODUCT. FOR A COMPLETE EXPLANATI ON OF THE TE CODES REFER TO SECTI ON 1. 7 OF THE INTRODUCTION.
SULFASALAZI NE
TABLET; ORAL
FAZINE
PRODUCTS CONSI DERED THERAPEUTI CALLY
EQUI VALENT TO EACH OTHER
PRODUCTS CONSI DERED NOT THERAPEUTI CALLY
EQUI VALENT TO ANY OTHER PRODUCTS LI STED
PRODUCTS CONSI DERED NOT THERAPEUTI CALLY
EQUI VALENT TO EACH OTHER
AB PARKLAND
SULAZINE
AB URSA
SULFASALAZI NE
BP BROWN
SULFASALAZI NE
TABLET; ORAL
FAZINE
AB PARKLAND
SULFASALAZI NE
BP BROWN
SOUTH
NOTE: BOLD FONT AND UNDERLI NI NG DENOTES MULTI SOURCE PRODUCTS WHI CH
EQUI VALENT.
500MG A042999 001
500MG A042222 001
500MG A041297 001
500MG A042999 001
500MG A041297 001
500MG A067627 001
ARE CONSI DERED THERAPEUTI CALLY
THI S EXAMPLE I S FOR PURPOSES OF I LLUSTRATI ON ONLY. I T DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE
PRESCRI PTI ON DRUG PRODUCT LI ST.
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
ABACAVIR SULFATE
SOLUTION;ORAL
ZIAGEN
+ VIIV HLTHCARE
TABLET;ORAL
ABACAVIR SULFATE
AB APOTEX INC
AB AUROBINDO PHARMA LTD
AB HETERO LABS LTD III
AB MYLAN PHARMS INC
ZIAGEN
AB + VIIV HLTHCARE
ABACAVIR SULFATE; LAMIVUDINE
TABLET;ORAL
EPZICOM
+ VIIV HLTHCARE
EQ 20MG BASE/ML
EQ 300MG BASE
EQ 300MG BASE
EQ 300MG BASE
EQ 300MG BASE
EQ 300MG BASE
EQ 600MG BASE;300MG
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
TABLET;ORAL
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
AB LUPIN LTD
TRIZIVIR
AB + VIIV HLTHCARE
ABIRATERONE ACETATE
TABLET;ORAL
ZYTIGA
+ JANSSEN BIOTECH
ACAMPROSATE CALCIUM
TABLET, DELAYED RELEASE;ORAL
ACAMPROSATE CALCIUM
AB BARR LABS DIV TEVA
AB GLENMARK GENERICS
CAMPRAL
AB + FOREST LABS
ACARBOSE
TABLET;ORAL
ACARBOSE
AB EMCURE PHARMS LTD
AB
AB
AB IMPAX LABS
AB
AB
AB MYLAN
AB
AB
AB ROXANE
AB
AB
AB STRIDES ARCOLAB LTD
AB
AB
AB VIRTUS PHARM
AB
AB
AB WATSON LABS
AB
AB
PRECOSE
AB + BAYER HLTHCARE
AB
AB
ACEBUTOLOL HYDROCHLORIDE
CAPSULE;ORAL
ACEBUTOLOL HYDROCHLORIDE
AB AMNEAL PHARM
AB
AB MYLAN
AB
AB WATSON LABS
EQ 300MG BASE;150MG;300MG
EQ 300MG BASE;150MG;300MG
250MG
333MG
333MG
333MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
EQ 200MG BASE
EQ 400MG BASE
EQ 200MG BASE
EQ 400MG BASE
EQ 200MG BASE
3-1( of 362)
N020978 001 Dec 17, 1998
A201570 001 Dec 17, 2012
A077844 001 Dec 17, 2012
A091560 001 Sep 13, 2013
A091294 001 Jun 18, 2012
N020977 001 Dec 17, 1998
N021652 001 Aug 02, 2004
A202912 001 Dec 05, 2013
N021205 001 Nov 14, 2000
N202379 001 Apr 28, 2011
A200143 001 Nov 18, 2013
A202229 001 Jul 16, 2013
N021431 001 Jul 29, 2004
A202271 001 Feb 07, 2012
A202271 002 Feb 07, 2012
A202271 003 Feb 07, 2012
A078441 001 May 14, 2009
A078441 002 May 14, 2009
A078441 003 May 14, 2009
A091053 001 Jan 06, 2011
A091053 002 Jan 06, 2011
A091053 003 Jan 06, 2011
A078470 001 May 07, 2008
A078470 002 May 07, 2008
A078470 003 May 07, 2008
A090912 001 Jul 27, 2011
A090912 002 Jul 27, 2011
A090912 003 Jul 27, 2011
A091343 001 Oct 17, 2013
A091343 002 Oct 17, 2013
A091343 003 Oct 17, 2013
A077532 001 May 07, 2008
A077532 002 May 07, 2008
A077532 003 May 07, 2008
N020482 004 May 29, 1997
N020482 001 Sep 06, 1995
N020482 002 Sep 06, 1995
A075047 001 Dec 30, 1999
A075047 002 Dec 30, 1999
A074288 001 Apr 24, 1995
A074288 002 Apr 24, 1995
A074007 001 Oct 18, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-2( of 362)
ACEBUTOLOL HYDROCHLORIDE
CAPSULE;ORAL
ACEBUTOLOL HYDROCHLORIDE
AB EQ 400MG BASE A074007 002 Oct 18, 1995
SECTRAL
AB PROMIUS PHARMA EQ 200MG BASE N018917 001 Dec 28, 1984
AB + EQ 400MG BASE N018917 003 Dec 28, 1984
ACETAMINOPHEN
SOLUTION;IV (INFUSION)
OFIRMEV
+ CADENCE PHARMS 1000MG/100ML (10MG/ML) N022450 001 Nov 02, 2010
ACETAMINOPHEN; BUTALBITAL
CAPSULE;ORAL
PHRENILIN FORTE
+ VALEANT 650MG;50MG A088831 001 Jun 19, 1985
TABLET;ORAL
BUTALBITAL AND ACETAMINOPHEN
+ NEXGEN PHARMA 300MG;50MG A090956 001 Aug 23, 2011
BUTAPAP
+ MIKART 325MG;50MG A089987 001 Oct 26, 1992
+ 650MG;50MG A089988 001 Oct 26, 1992
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
+ MIKART 325MG;50MG;40MG A089007 001 Mar 17, 1986
+ NEXGEN PHARMA 300MG;50MG;40MG A040885 001 Nov 16, 2009
ESGIC-PLUS
+ MIKART 500MG;50MG;40MG A040085 001 Mar 28, 1996
SOLUTION;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
+ MIKART 325MG/15ML;50MG/15ML;40MG/15ML A040387 001 Jan 31, 2003
TABLET;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
AA LANNETT HOLDINGS INC 325MG;50MG;40MG A200243 001 Sep 13, 2012
AA MALLINCKRODT 325MG;50MG;40MG A087804 001 Jan 24, 1985
AA MIKART 325MG;50MG;40MG A089175 001 Jan 21, 1987
AA MIRROR PHARMS 325MG;50MG;40MG A040864 001 Dec 01, 2008
AA VINTAGE PHARMS 325MG;50MG;40MG A040511 001 Aug 27, 2003
AA 500MG;50MG;40MG A040513 001 Aug 25, 2003
AA WATSON LABS 500MG;50MG;40MG A040267 001 Jul 30, 1998
AA WEST WARD 325MG;50MG;40MG A089718 001 Jun 12, 1995
ESGIC-PLUS
AA + MIKART 500MG;50MG;40MG A089451 001 May 23, 1988
FIORICET
AA + WATSON PHARMS 325MG;50MG;40MG A088616 001 Nov 09, 1984
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
+ MIKART 750MG;50MG;40MG A040496 001 Dec 23, 2003
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE;ORAL
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
AB NEXGEN PHARMA INC 325MG;50MG;40MG;30MG A076560 001 Jun 10, 2004
AB VINTAGE PHARMS 325MG;50MG;40MG;30MG A075929 001 Apr 22, 2002
AB WEST WARD 325MG;50MG;40MG;30MG A075618 001 Mar 23, 2001
FIORICET W/ CODEINE
AB + WATSON LABS INC 325MG;50MG;40MG;30MG N020232 001 Jul 30, 1992
PHRENILIN WITH CAFFEINE AND CODEINE
AB VALEANT 325MG;50MG;40MG;30MG A074911 001 Aug 22, 2001
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
NEXGEN PHARMA INC 300MG;50MG;40MG;30MG A076560 002 Jul 19, 2012
ACETAMINOPHEN; CODEINE PHOSPHATE
SOLUTION;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
AA HI TECH PHARMA 120MG/5ML;12MG/5ML A040119 001 Apr 26, 1996
AA MIKART 120MG/5ML;12MG/5ML A089450 001 Oct 27, 1992
AA + PHARM ASSOC 120MG/5ML;12MG/5ML A087508 001
AA VINTAGE PHARMS 120MG/5ML;12MG/5ML A091238 001 Nov 10, 2011
AA WOCKHARDT 120MG/5ML;12MG/5ML A087006 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-3( of 362)
ACETAMINOPHEN; CODEINE PHOSPHATE
SUSPENSION;ORAL
CAPITAL AND CODEINE
+ VALEANT PHARMS LLC 120MG/5ML;12MG/5ML A086024 001
TABLET;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
AA AMNEAL PHARMS NY 300MG;30MG A040779 001 May 29, 2008
AA AUROLIFE PHARMA LLC 300MG;15MG A202800 001 Apr 15, 2013
AA 300MG;30MG A202800 002 Apr 15, 2013
AA 300MG;60MG A202800 003 Apr 15, 2013
AA + MALLINCKRODT INC 300MG;15MG A040419 001 May 31, 2001
AA 300MG;30MG A040419 002 May 31, 2001
AA 300MG;60MG A040419 003 May 31, 2001
AA RANBAXY 300MG;30MG A085868 001
AA 300MG;60MG A087083 001
AA TEVA 300MG;15MG A088627 001 Mar 06, 1985
AA 300MG;30MG A088628 001 Mar 06, 1985
AA + 300MG;60MG A088629 001 Mar 06, 1985
AA VINTAGE 300MG;15MG A089990 001 Sep 30, 1988
AA 300MG;30MG A089805 001 Sep 30, 1988
AA VINTAGE PHARMS 300MG;60MG A089828 001 Sep 30, 1988
TYLENOL W/ CODEINE NO. 3
AA + JANSSEN PHARMS 300MG;30MG A085055 003
TYLENOL W/ CODEINE NO. 4
AA JANSSEN PHARMS 300MG;60MG A085055 004
ACETAMINOPHEN; HYDROCODONE BITARTRATE
SOLUTION;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AA BOCA PHARMA LLC 325MG/15ML;7.5MG/15ML A040894 001 Jul 19, 2011
AA MALLINCKRODT 500MG/15ML;7.5MG/15ML A040418 001 Jun 27, 2001
AA + MIKART 325MG/15ML;7.5MG/15ML A040482 001 Sep 25, 2003
AA + 500MG/15ML;7.5MG/15ML A081051 001 Aug 28, 1992
AA PAI 325MG/15ML;7.5MG/15ML A040838 001 May 10, 2013
AA PHARM ASSOC 500MG/15ML;7.5MG/15ML A040182 001 Mar 13, 1998
AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML A040520 001 Oct 30, 2003
AA VISTAPHARM 325MG/15ML;7.5MG/15ML A200343 001 Jan 25, 2012
+ MIKART 300MG/15ML;10MG/15ML A040881 001 Feb 25, 2010
+ PHARM ASSOC 325MG/15ML;10MG/15ML A040834 001 Apr 18, 2008
TABLET;ORAL
ANEXSIA
AA MALLINCKRODT 500MG;5MG A089160 001 Apr 23, 1987
AA 750MG;10MG A040468 001 Oct 31, 2002
ANEXSIA 5/325
AA MALLINCKRODT 325MG;5MG A040409 001 Oct 20, 2000
ANEXSIA 7.5/325
AA MALLINCKRODT 325MG;7.5MG A040405 001 Sep 08, 2000
ANEXSIA 7.5/650
AA MALLINCKRODT 650MG;7.5MG A089725 001 Sep 30, 1987
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AA AMNEAL PHARMS NY 325MG;5MG A040736 001 Aug 25, 2006
AA 325MG;10MG A040746 001 Aug 25, 2006
AA 500MG;5MG A040729 001 Aug 25, 2006
AA 500MG;7.5MG A040748 001 Aug 25, 2006
AA 500MG;10MG A040813 001 Feb 23, 2007
AA 650MG;7.5MG A040754 001 Aug 25, 2006
AA 650MG;10MG A040757 001 Aug 25, 2006
AA 750MG;7.5MG A040769 001 Aug 28, 2006
AA AUROLIFE PHARMA LLC 325MG;5MG A201013 001 Apr 11, 2012
AA 325MG;7.5MG A201013 002 Apr 11, 2012
AA 325MG;10MG A201013 003 Apr 11, 2012
AA BOCA PHARMA LLC 300MG;5MG A090415 001 Jan 24, 2011
AA 300MG;7.5MG A090415 002 Jan 24, 2011
AA 300MG;10MG A090415 003 Jan 24, 2011
AA CARACO 325MG;5MG A090118 001 Dec 23, 2008
AA 325MG;7.5MG A090118 002 Dec 23, 2008
AA 325MG;10MG A090118 003 Dec 23, 2008
AA 500MG;5MG A090265 001 Dec 23, 2008
AA 500MG;7.5MG A090265 002 Dec 23, 2008
AA 500MG;10MG A090265 003 Dec 23, 2008
AA 650MG;7.5MG A090380 001 Dec 23, 2008
AA 650MG;10MG A090380 002 Dec 23, 2008
AA 660MG;10MG A090380 003 Dec 23, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-4( of 362)
ACETAMINOPHEN; HYDROCODONE BITARTRATE
TABLET;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AA 750MG;7.5MG A090380 004 Dec 23, 2008
AA MALLINCKRODT 325MG;10MG A040400 001 Jul 26, 2000
AA 500MG;5MG A040084 002 Jun 01, 1995
AA 500MG;7.5MG A040201 001 Feb 27, 1998
AA 500MG;10MG A040201 002 Feb 27, 1998
AA 650MG;10MG A040084 004 Oct 16, 1996
AA + 660MG;10MG A040084 003 Jul 29, 1996
AA 750MG;7.5MG A040084 001 Jun 01, 1995
AA + MIKART 300MG;5MG A040658 001 Jan 19, 2006
AA + 300MG;7.5MG A040556 002 Mar 24, 2006
AA + 300MG;10MG A040556 001 Jun 23, 2004
AA 325MG;7.5MG A040432 001 Jan 22, 2003
AA + 500MG;7.5MG A089699 001 Aug 25, 1989
AA + 650MG;7.5MG A089689 001 Jun 29, 1988
AA + 650MG;10MG A081223 001 May 29, 1992
AA TRIS PHARMA INC 325MG;5MG A202214 001 Mar 27, 2013
AA 325MG;7.5MG A202214 002 Mar 27, 2013
AA 325MG;10MG A202214 003 Mar 27, 2013
AA VINTAGE PHARMS 325MG;5MG A040655 001 Jan 19, 2006
AA 325MG;7.5MG A040656 001 Jan 19, 2006
AA 325MG;10MG A040355 001 May 31, 2000
AA 500MG;2.5MG A040144 002 Apr 25, 1997
AA 500MG;5MG A089971 001 Dec 02, 1988
AA 500MG;7.5MG A040144 001 Feb 22, 1996
AA 500MG;10MG A040356 001 May 31, 2000
AA 650MG;7.5MG A040155 001 Apr 14, 1997
AA 650MG;10MG A040143 001 Feb 22, 1996
AA 660MG;10MG A040358 001 May 31, 2000
AA 750MG;7.5MG A040157 001 Apr 12, 1996
AA WATSON LABS 500MG;2.5MG A081079 001 Aug 30, 1991
AA 500MG;5MG A089883 001 Dec 01, 1988
AA 500MG;7.5MG A081080 001 Aug 30, 1991
AA 500MG;10MG A040148 002 Feb 14, 1997
AA 650MG;7.5MG A040094 001 Sep 29, 1995
AA 650MG;10MG A040094 002 Sep 29, 1995
AA 660MG;10MG A040094 003 Aug 08, 2000
AA 750MG;7.5MG A081083 001 Aug 30, 1991
AA + 750MG;10MG A040094 004 Mar 22, 1999
AA WATSON LABS FLORIDA 660MG;10MG A040495 001 May 28, 2003
LORTAB
AA UCB INC 500MG;5MG A087722 001 Jul 09, 1982
AA + 500MG;10MG A040100 001 Jan 26, 1996
NORCO
AA + WATSON LABS 325MG;5MG A040099 001 Jun 25, 1997
AA + 325MG;7.5MG A040148 003 Sep 12, 2000
AA + 325MG;10MG A040148 001 Feb 14, 1997
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
+ MIKART 325MG;2.5MG A040846 001 Jun 09, 2010
ZYDONE
+ VINTAGE PHARMS LLC 400MG;5MG A040288 001 Nov 27, 1998
+ 400MG;7.5MG A040288 002 Nov 27, 1998
+ 400MG;10MG A040288 003 Nov 27, 1998
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
CAPSULE;ORAL
OXYCODONE AND ACETAMINOPHEN
AA DURAMED PHARMS BARR 500MG;5MG A040289 001 Mar 16, 1999
AA MALLINCKRODT 500MG;5MG A040257 001 Aug 04, 1998
AA VINTAGE PHARMS 500MG;5MG A040106 001 Jul 30, 1996
AA WATSON LABS 500MG;5MG A040234 001 Oct 30, 1997
ROXILOX
AA ROXANE 500MG;5MG A040061 001 Jul 03, 1995
TYLOX
AA + JANSSEN PHARMS 500MG;5MG A088790 001 Dec 12, 1984
SOLUTION;ORAL
ROXICET
AA + ROXANE 325MG/5ML;5MG/5ML A089351 001 Dec 03, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-5( of 362)
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
TABLET;ORAL
OXYCET
AA MALLINCKRODT 325MG;5MG A087463 001 Dec 07, 1983
OXYCODONE AND ACETAMINOPHEN
AA ACTAVIS ELIZABETH 325MG;2.5MG A201447 001 Apr 12, 2013
AA 325MG;5MG A201447 002 Apr 12, 2013
AA 325MG;7.5MG A201447 003 Apr 12, 2013
AA 325MG;10MG A201447 004 Apr 12, 2013
AA ACTAVIS TOTOWA 325MG;7.5MG A040800 001 Apr 03, 2012
AA 325MG;10MG A040800 002 Apr 03, 2012
AA ALVOGEN INC 325MG;7.5MG A202677 001 Jul 26, 2012
AA 325MG;10MG A202677 002 Jul 26, 2012
AA AMNEAL PHARMS NY 325MG;5MG A040777 001 Nov 27, 2007
AA 325MG;10MG A040778 001 Nov 27, 2007
AA 500MG;7.5MG A040789 001 Nov 27, 2007
AA 650MG;10MG A040789 002 Nov 27, 2007
AA AUROLIFE PHARMA LLC 325MG;2.5MG A201972 001 Jul 15, 2013
AA 325MG;5MG A201972 002 Jul 15, 2013
AA 325MG;7.5MG A201972 003 Jul 15, 2013
AA 325MG;10MG A201972 004 Jul 15, 2013
AA CARACO 325MG;2.5MG A090535 001 Dec 26, 2013
AA 325MG;5MG A090535 002 Dec 26, 2013
AA 325MG;7.5MG A090535 003 Dec 26, 2013
AA 325MG;10MG A090535 004 Dec 26, 2013
AA COASTAL PHARMS 325MG;2.5MG A090177 001 Oct 20, 2008
AA 325MG;5MG A090177 002 Oct 20, 2008
AA 325MG;7.5MG A090177 003 Oct 20, 2008
AA 325MG;10MG A090177 004 Oct 20, 2008
AA 500MG;7.5MG A090177 005 Oct 20, 2008
AA 650MG;10MG A090177 006 Oct 20, 2008
AA MALLINCKRODT 325MG;7.5MG A040545 001 Jun 30, 2004
AA 325MG;10MG A040545 002 Jun 30, 2004
AA 500MG;7.5MG A040550 001 Jun 30, 2004
AA 650MG;10MG A040550 002 Jun 30, 2004
AA VINTAGE PHARMS 325MG;2.5MG A090733 001 Jul 11, 2013
AA 325MG;5MG A040105 001 Jul 30, 1996
AA 325MG;7.5MG A090734 001 Jul 11, 2013
AA 325MG;10MG A090734 002 Jul 11, 2013
AA WATSON LABS 325MG;5MG A040171 001 Oct 30, 1997
AA 325MG;7.5MG A040535 001 Sep 05, 2003
AA 325MG;10MG A040535 002 Sep 05, 2003
AA 500MG;7.5MG A040371 001 Dec 29, 2000
AA 650MG;10MG A040371 002 Dec 29, 2000
PERCOCET
AA + VINTAGE PHARMS LLC 325MG;2.5MG A040330 001 Jun 25, 1999
AA + 325MG;5MG A040330 002 Jun 25, 1999
AA + 325MG;7.5MG A040434 001 Nov 23, 2001
AA + 325MG;10MG A040434 002 Nov 23, 2001
AA + 500MG;7.5MG A040341 001 Jul 26, 1999
AA + 650MG;10MG A040341 002 Jul 26, 1999
ROXICET
AA ROXANE 325MG;5MG A087003 001
OXYCODONE AND ACETAMINOPHEN
+ MIKART 300MG;2.5MG A040608 001 Dec 30, 2005
+ 300MG;5MG A040608 002 Dec 30, 2005
+ 300MG;7.5MG A040608 003 Dec 30, 2005
+ 300MG;10MG A040608 004 Dec 30, 2005
+ 400MG;5MG A040687 001 Apr 27, 2006
+ 400MG;7.5MG A040698 001 Apr 27, 2006
+ 400MG;10MG A040692 001 Apr 27, 2006
500MG;10MG A040676 001 Apr 19, 2006
ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
AB GAVIS PHARMS 650MG;EQ 25MG BASE A076202 001 Aug 02, 2002
AB + WATSON LABS 650MG;EQ 25MG BASE A074699 001 Mar 24, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-6( of 362)
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
TABLET;ORAL
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
AB ALVOGEN INC 325MG;37.5MG A202076 001 Mar 30, 2012
AB AMNEAL PHARMS 325MG;37.5MG A090485 001 Dec 09, 2009
AB CARACO 325MG;37.5MG A077184 001 Dec 16, 2005
AB MICRO LABS LTD INDIA 325MG;37.5MG A201952 001 Dec 14, 2012
AB MYLAN 325MG;37.5MG A077858 001 Sep 26, 2008
AB PAR PHARM 325MG;37.5MG A076475 001 Apr 21, 2005
AB WATSON LABS 325MG;37.5MG A076914 001 Jul 26, 2006
AB ZYDUS PHARMS USA INC 325MG;37.5MG A090460 001 Sep 06, 2012
ULTRACET
AB + JANSSEN PHARMS 325MG;37.5MG N021123 001 Aug 15, 2001
ACETAZOLAMIDE
CAPSULE, EXTENDED RELEASE;ORAL
ACETAZOLAMIDE
AB HERITAGE PHARMS INC 500MG A090779 001 Jul 14, 2011
AB ZYDUS PHARMS USA INC 500MG A040904 001 Dec 10, 2008
DIAMOX
AB + DURAMED PHARMS BARR 500MG N012945 001
TABLET;ORAL
ACETAZOLAMIDE
AB LANNETT 250MG A084840 001
AB MUTUAL PHARM 125MG A089752 001 Jun 22, 1988
AB TARO 125MG A040195 001 May 28, 1997
AB + 250MG A040195 002 May 28, 1997
ACETAZOLAMIDE SODIUM
INJECTABLE;INJECTION
ACETAZOLAMIDE SODIUM
AP BEDFORD EQ 500MG BASE/VIAL A040089 001 Feb 28, 1995
AP SAGENT AGILA EQ 500MG BASE/VIAL A200880 001 May 09, 2012
AP + X GEN PHARMS EQ 500MG BASE/VIAL A040784 001 Dec 10, 2008
ACETIC ACID, GLACIAL
SOLUTION;IRRIGATION, URETHRAL
ACETIC ACID 0.25% IN PLASTIC CONTAINER
AT B BRAUN 250MG/100ML N018161 001
AT BAXTER HLTHCARE 250MG/100ML N018523 001 Feb 19, 1982
AT HOSPIRA 250MG/100ML N017656 001
SOLUTION/DROPS;OTIC
ACETIC ACID
AT TARO 2% A088638 001 Sep 06, 1984
AT VINTAGE 2% A040607 001 Feb 24, 2005
AT + WOCKHARDT 2% A040166 001 Jul 26, 1996
VOSOL
AT HI TECH PHARMA 2% N012179 001
ACETIC ACID, GLACIAL; ALUMINUM ACETATE
SOLUTION/DROPS;OTIC
ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE
+ BAUSCH AND LOMB 2%;0.79% A040063 001 Feb 25, 1994
ACETIC ACID, GLACIAL; HYDROCORTISONE
SOLUTION/DROPS;OTIC
ACETASOL HC
AT ACTAVIS MID ATLANTIC 2%;1% A087143 001 Jan 13, 1982
HYDROCORTISONE AND ACETIC ACID
AT TARO 2%;1% A088759 001 Mar 04, 1985
AT VINTAGE 2%;1% A040609 001 Feb 06, 2006
VOSOL HC
AT + HI TECH PHARMA 2%;1% N012770 001
ACETOHEXAMIDE
TABLET;ORAL
ACETOHEXAMIDE
WATSON LABS 250MG A071893 001 Nov 25, 1987
+ 500MG A071894 001 Nov 25, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-7( of 362)
ACETOHYDROXAMIC ACID
TABLET;ORAL
LITHOSTAT
+ MISSION PHARMA 250MG N018749 001 May 31, 1983
ACETYLCHOLINE CHLORIDE
FOR SOLUTION;OPHTHALMIC
MIOCHOL-E
+ BAUSCH AND LOMB 20MG/VIAL N020213 001 Sep 22, 1993
ACETYLCYSTEINE
INJECTABLE;INTRAVENOUS
ACETADOTE
AP + CUMBERLAND PHARMS 6GM/30ML (200MG/ML) N021539 001 Jan 23, 2004
ACETYLCYSTEINE
AP INNOPHARMA LICENSING 6GM/30ML (200MG/ML) A200644 001 Nov 07, 2012
SOLUTION;INHALATION, ORAL
ACETYLCYSTEINE
AN BEDFORD 10% A072323 001 Apr 30, 1992
AN 20% A072324 001 Apr 30, 1992
AN HOSPIRA 10% A073664 001 Aug 30, 1994
AN 20% A074037 001 Aug 30, 1994
AN INNOPHARMA LICENSING 20% A203853 001 Jun 21, 2012
AN + LUITPOLD 10% A072489 001 Jul 28, 1995
AN + 20% A072547 001 Jul 28, 1995
ACITRETIN
CAPSULE;ORAL
ACITRETIN
AB BARR LABS INC 10MG A091455 001 Apr 04, 2013
AB 25MG A091455 002 Apr 04, 2013
AB TEVA PHARMS USA 17.5MG A202897 001 Apr 04, 2013
AB 22.5MG A202897 002 Apr 04, 2013
SORIATANE
AB STIEFEL LABS INC 10MG N019821 001 Oct 28, 1996
AB 17.5MG N019821 003 Aug 06, 2009
AB 22.5MG N019821 004 Aug 06, 2009
AB + 25MG N019821 002 Oct 28, 1996
ACLIDINIUM BROMIDE
POWDER, METERED;INHALATION
TUDORZA PRESSAIR
+ FOREST LABS INC 0.375MG/INH N202450 001 Jul 23, 2012
ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE;ORAL
SEMPREX-D
+ ACTIENT PHARMS 8MG;60MG N019806 001 Mar 25, 1994
ACYCLOVIR
CAPSULE;ORAL
ACYCLOVIR
AB APOTEX INC 200MG A075677 001 Sep 28, 2005
AB DAVA PHARMS INC 200MG A074833 001 Apr 22, 1997
AB MYLAN 200MG A074727 001 Apr 22, 1997
AB RANBAXY 200MG A074975 001 Sep 30, 1998
AB STASON 200MG A075090 001 Jan 26, 1999
AB TEVA 200MG A074578 001 Apr 22, 1997
ZOVIRAX
AB + GLAXOSMITHKLINE 200MG N018828 001 Jan 25, 1985
CREAM;TOPICAL
ZOVIRAX
+ VALEANT BERMUDA 5% N021478 001 Dec 30, 2002
OINTMENT;TOPICAL
ACYCLOVIR
AB MYLAN PHARMS INC 5% A202459 001 Apr 03, 2013
ZOVIRAX
AB + VALEANT BERMUDA 5% N018604 001 Mar 29, 1982
SUSPENSION;ORAL
ACYCLOVIR
AB ACTAVIS MID ATLANTIC 200MG/5ML A074738 001 Apr 28, 1997
AB HI TECH PHARMA 200MG/5ML A077026 001 Jun 07, 2005
ZOVIRAX
AB + DELCOR ASSET 200MG/5ML N019909 001 Dec 22, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-8( of 362)
ACYCLOVIR
TABLET;ORAL
ACYCLOVIR
AB APOTEX INC 400MG A077309 001 Sep 29, 2005
AB 800MG A077309 002 Sep 29, 2005
AB CADILA PHARMS LTD 400MG A202168 001 Nov 15, 2013
AB 800MG A202168 002 Nov 15, 2013
AB CARLSBAD 400MG A075382 001 Apr 30, 1999
AB 800MG A075382 002 Apr 30, 1999
AB DAVA PHARMS INC 400MG A074946 001 Nov 19, 1997
AB 800MG A074946 002 Nov 19, 1997
AB HETERO LABS LTD V 400MG A203834 001 Oct 29, 2013
AB 800MG A203834 002 Oct 29, 2013
AB MYLAN 400MG A075211 001 Sep 28, 1998
AB 800MG A075211 002 Sep 28, 1998
AB RANBAXY 400MG A074980 001 Sep 30, 1998
AB 800MG A074980 002 Sep 30, 1998
AB TEVA 400MG A074556 002 Apr 22, 1997
AB 800MG A074556 003 Apr 22, 1997
ZOVIRAX
AB GLAXOSMITHKLINE 400MG N020089 001 Apr 30, 1991
AB + 800MG N020089 002 Apr 30, 1991
ACYCLOVIR SODIUM
INJECTABLE;INJECTION
ACYCLOVIR SODIUM
AP AUROBINDO PHARMA LTD EQ 50MG BASE/ML A203701 001 Oct 11, 2013
AP BEDFORD EQ 1GM BASE/VIAL A074596 001 Apr 22, 1997
AP EQ 500MG BASE/VIAL A074596 002 Apr 22, 1997
AP + FRESENIUS KABI USA EQ 50MG BASE/ML A074930 001 May 13, 1998
AP + EQ 500MG BASE/VIAL A075015 001 Apr 30, 1998
AP HIKMA MAPLE EQ 1GM BASE/VIAL A074913 002 Oct 15, 1997
AP EQ 500MG BASE/VIAL A074913 001 Oct 15, 1997
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE
HIKMA MAPLE EQ 1GM BASE/VIAL A074885 002 Dec 19, 1997
+ EQ 500MG BASE/VIAL A074885 001 Dec 19, 1997
ACYCLOVIR; HYDROCORTISONE
CREAM;TOPICAL
XERESE
+ VALEANT BERMUDA 5%;1% N022436 001 Jul 31, 2009
ADAPALENE
CREAM;TOPICAL
ADAPALENE
AB FOUGERA PHARMS 0.1% A090824 001 Jun 30, 2010
DIFFERIN
AB + GALDERMA LABS LP 0.1% N020748 001 May 26, 2000
GEL;TOPICAL
ADAPALENE
AB GLENMARK GENERICS 0.1% A091314 001 Jul 01, 2010
AB PLIVA HRVATSKA DOO 0.1% A090962 001 Jun 02, 2010
AB TOLMAR 0.3% A200298 001 Jun 14, 2012
DIFFERIN
AB + GALDERMA LABS LP 0.1% N020380 001 May 31, 1996
AB + 0.3% N021753 001 Jun 19, 2007
LOTION;TOPICAL
DIFFERIN
+ GALDERMA LABS LP 0.1% N022502 001 Mar 17, 2010
ADAPALENE; BENZOYL PEROXIDE
GEL;TOPICAL
EPIDUO
+ GALDERMA LABS LP 0.1%;2.5% N022320 001 Dec 08, 2008
ADEFOVIR DIPIVOXIL
TABLET;ORAL
ADEFOVIR DIPIVOXIL
AB SIGMAPHARM LABS LLC 10MG A202051 001 Aug 29, 2013
HEPSERA
AB + GILEAD 10MG N021449 001 Sep 20, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-9( of 362)
ADENOSINE
INJECTABLE;INJECTION
ADENOCARD
AP + ASTELLAS 3MG/ML N019937 002 Oct 30, 1989
ADENOSCAN
AP + ASTELLAS 3MG/ML N020059 001 May 18, 1995
ADENOSINE
AP AKORN 3MG/ML A078076 001 Oct 31, 2008
AP BEDFORD 3MG/ML A076404 001 Jun 16, 2004
AP FRESENIUS KABI USA 3MG/ML A077133 001 Apr 27, 2005
AP GLAND PHARMA LTD 3MG/ML A077283 001 Jun 14, 2007
AP HIKMA MAPLE 3MG/ML A076500 001 Jun 16, 2004
AP LUITPOLD 3MG/ML A090010 001 Apr 28, 2009
AP STRIDES ARCOLAB LTD 3MG/ML A078686 001 May 13, 2009
AP TEVA PHARMS USA 3MG/ML A077425 001 Aug 29, 2013
AP WOCKHARDT 3MG/ML A090220 001 Jul 20, 2009
AFATINIB DIMALEATE
TABLET;ORAL
GILOTRIF
BOEHRINGER INGELHEIM EQ 20MG BASE N201292 001 Jul 12, 2013
EQ 30MG BASE N201292 002 Jul 12, 2013
+ EQ 40MG BASE N201292 003 Jul 12, 2013
ALBENDAZOLE
TABLET;ORAL
ALBENZA
+ AMEDRA PHARMS 200MG N020666 001 Jun 11, 1996
ALBUMIN HUMAN
INJECTABLE;INJECTION
OPTISON
+ GE HEALTHCARE 10MG/ML N020899 001 Dec 31, 1997
ALBUMIN IODINATED I-125 SERUM
INJECTABLE;INJECTION
JEANATOPE
ISO TEX 100uCi/10ML (10uCi/ML) N017836 003 Jun 08, 2004
500uCi/0.5ML N017836 001
+ 1,000uCi/ML N017836 002
ALBUMIN IODINATED I-131 SERUM
INJECTABLE;INJECTION
MEGATOPE
+ ISO TEX 0.5mCi/VIAL N017837 001
+ 1mCi/VIAL N017837 002
ALBUTEROL SULFATE
AEROSOL, METERED;INHALATION
PROAIR HFA
BX + TEVA BRANDED PHARM EQ 0.09MG BASE/INH N021457 001 Oct 29, 2004
PROVENTIL-HFA
BX + 3M EQ 0.09MG BASE/INH N020503 001 Aug 15, 1996
VENTOLIN HFA
BX + GLAXO GRP LTD EQ 0.09MG BASE/INH N020983 001 Apr 19, 2001
SOLUTION;INHALATION
ACCUNEB
AN + DEY EQ 0.021% BASE N020949 002 Apr 30, 2001
AN + EQ 0.042% BASE N020949 001 Apr 30, 2001
ALBUTEROL SULFATE
AN + BAUSCH AND LOMB EQ 0.5% BASE A075050 001 Jun 18, 1998
AN HI TECH PHARMA EQ 0.083% BASE A075063 001 Feb 09, 1999
AN EQ 0.5% BASE A074543 001 Jan 15, 1998
AN LANDELA PHARM EQ 0.083% BASE A077569 001 Apr 04, 2006
AN + MYLAN SPECLT EQ 0.083% BASE A072652 001 Feb 21, 1992
AN NEPHRON EQ 0.021% BASE A076355 002 Mar 31, 2010
AN EQ 0.042% BASE A076355 001 Jun 28, 2004
AN EQ 0.083% BASE A074880 001 Sep 17, 1997
AN EQ 0.5% BASE A075664 001 Jun 26, 2001
AN RITEDOSE CORP EQ 0.083% BASE A077839 001 Dec 16, 2008
AN TEVA PHARMS EQ 0.083% BASE A075343 001 Nov 09, 1999
AN WATSON LABS EQ 0.021% BASE A077772 001 Sep 25, 2007
AN EQ 0.042% BASE A077772 002 Sep 25, 2007
AN WATSON LABS INC EQ 0.083% BASE A076370 001 Nov 24, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-10( of 362)
ALBUTEROL SULFATE
SYRUP;ORAL
ALBUTEROL SULFATE
AA ACTAVIS MID ATLANTIC EQ 2MG BASE/5ML A074454 001 Sep 25, 1995
AA AMNEAL PHARMS EQ 2MG BASE/5ML A079241 001 May 12, 2010
AA HI TECH PHARMA EQ 2MG BASE/5ML A074749 001 Jan 30, 1998
AA + TEVA EQ 2MG BASE/5ML A073419 001 Mar 30, 1992
AA VINTAGE EQ 2MG BASE/5ML A078105 001 Dec 27, 2006
AA VISTAPHARM EQ 2MG BASE/5ML A077788 001 Jun 26, 2007
TABLET;ORAL
ALBUTEROL SULFATE
AB MUTUAL PHARM EQ 2MG BASE A072637 002 Dec 05, 1989
AB EQ 4MG BASE A072637 001 Dec 05, 1989
AB MYLAN EQ 2MG BASE A072894 002 Jan 17, 1991
AB + EQ 4MG BASE A072894 001 Jan 17, 1991
AB WATSON LABS EQ 2MG BASE A072764 001 Aug 28, 1991
TABLET, EXTENDED RELEASE;ORAL
ALBUTEROL SULFATE
AB MYLAN EQ 4MG BASE A078092 002 Jan 29, 2007
AB EQ 8MG BASE A078092 001 Jan 29, 2007
VOSPIRE ER
AB DAVA PHARMS INC EQ 4MG BASE A076130 002 Sep 26, 2002
AB + EQ 8MG BASE A076130 003 Sep 26, 2002
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
AEROSOL, METERED;INHALATION
COMBIVENT
+ BOEHRINGER INGELHEIM EQ 0.09MG BASE/INH;0.018MG/INH N020291 001 Oct 24, 1996
SOLUTION;INHALATION
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
AN CIPLA LTD EQ 0.083% BASE;0.017% A077559 001 Dec 31, 2007
AN NEPHRON EQ 0.083% BASE;0.017% A076749 001 Dec 31, 2007
AN RITEDOSE CORP EQ 0.083% BASE;0.017% A202496 001 Oct 01, 2012
AN TEVA PHARMS EQ 0.083% BASE;0.017% A076724 001 Dec 31, 2007
AN WATSON LABS EQ 0.083% BASE;0.017% A077063 001 Dec 31, 2007
DUONEB
AN + DEY EQ 0.083% BASE;0.017% N020950 001 Mar 21, 2001
SPRAY, METERED;INHALATION
COMBIVENT RESPIMAT
+ BOEHRINGER INGELHEIM EQ 0.1MG BASE/INH;0.02MG/INH N021747 001 Oct 07, 2011
ALCAFTADINE
SOLUTION/DROPS;OPHTHALMIC
LASTACAFT
+ ALLERGAN 0.25% N022134 001 Jul 28, 2010
ALCLOMETASONE DIPROPIONATE
CREAM;TOPICAL
ACLOVATE
AB + FOUGERA PHARMS 0.05% N018707 001 Dec 14, 1982
ALCLOMETASONE DIPROPIONATE
AB FOUGERA PHARMS 0.05% A076973 001 Jul 12, 2005
AB GLENMARK GENERICS 0.05% A079061 001 Jun 23, 2009
AB TARO 0.05% A076587 001 Sep 15, 2005
OINTMENT;TOPICAL
ACLOVATE
AB + FOUGERA PHARMS 0.05% N018702 001 Dec 14, 1982
ALCLOMETASONE DIPROPIONATE
AB FOUGERA PHARMS 0.05% A076884 001 Jul 18, 2005
AB GLENMARK GENERICS 0.05% A079227 001 Jul 30, 2009
AB TARO 0.05% A076730 001 Jul 29, 2004
ALCOHOL; DEXTROSE
INJECTABLE;INJECTION
ALCOHOL 5% AND DEXTROSE 5%
AP + B BRAUN 5ML/100ML;5GM/100ML N004589 004
ALCOHOL 10% AND DEXTROSE 5%
+ B BRAUN 10ML/100ML;5GM/100ML N004589 006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-11( of 362)
ALENDRONATE SODIUM
SOLUTION;ORAL
ALENDRONATE SODIUM
AA ROXANE EQ 70MG BASE/75ML A090520 001 Feb 25, 2013
FOSAMAX
AA + MERCK EQ 70MG BASE/75ML N021575 001 Sep 17, 2003
TABLET;ORAL
ALENDRONATE SODIUM
AB APOTEX EQ 5MG BASE A077982 001 Aug 04, 2008
AB EQ 10MG BASE A077982 002 Aug 04, 2008
AB EQ 35MG BASE A077982 003 Aug 04, 2008
AB EQ 70MG BASE A077982 004 Aug 04, 2008
AB AUROBINDO PHARMA EQ 10MG BASE A090124 001 Aug 04, 2008
AB EQ 35MG BASE A090124 002 Aug 04, 2008
AB EQ 70MG BASE A090124 003 Aug 04, 2008
AB AUSTARPHARMA LLC EQ 5MG BASE A090258 001 Sep 24, 2009
AB EQ 10MG BASE A090258 002 Sep 24, 2009
AB EQ 35MG BASE A090258 003 Sep 24, 2009
AB EQ 70MG BASE A090258 004 Sep 24, 2009
AB CADISTA PHARMS EQ 5MG BASE A090557 001 Feb 18, 2010
AB EQ 10MG BASE A090557 002 Feb 18, 2010
AB EQ 35MG BASE A090557 003 Feb 18, 2010
AB EQ 70MG BASE A090557 004 Feb 18, 2010
AB CIPLA LTD EQ 5MG BASE A076768 001 Aug 04, 2008
AB EQ 10MG BASE A076768 002 Aug 04, 2008
AB EQ 35MG BASE A076768 003 Aug 04, 2008
AB EQ 40MG BASE A076768 004 Aug 04, 2008
AB EQ 70MG BASE A076768 005 Aug 04, 2008
AB DR REDDYS LABS LTD EQ 5MG BASE A079109 001 Aug 04, 2008
AB EQ 10MG BASE A079109 002 Aug 04, 2008
AB EQ 35MG BASE A079049 001 Aug 04, 2008
AB EQ 70MG BASE A079049 002 Aug 04, 2008
AB MYLAN EQ 5MG BASE A076584 001 Aug 04, 2008
AB EQ 10MG BASE A076584 002 Aug 04, 2008
AB EQ 35MG BASE A076584 003 Aug 04, 2008
AB EQ 70MG BASE A076584 004 Aug 04, 2008
AB SUN PHARMA GLOBAL EQ 5MG BASE A090022 001 Sep 10, 2008
AB EQ 10MG BASE A090022 002 Sep 10, 2008
AB EQ 35MG BASE A090022 003 Sep 10, 2008
AB EQ 70MG BASE A090022 004 Sep 10, 2008
AB TEVA PHARMS EQ 5MG BASE A075710 001 Feb 06, 2008
AB EQ 10MG BASE A075710 002 Feb 06, 2008
AB EQ 35MG BASE A075710 003 Feb 06, 2008
AB EQ 40MG BASE A075710 004 Feb 06, 2008
AB EQ 70MG BASE A075710 005 Feb 06, 2008
AB WATSON LABS EQ 35MG BASE A076984 001 Aug 04, 2008
AB EQ 40MG BASE A076984 002 Aug 04, 2008
AB EQ 70MG BASE A076984 003 Aug 04, 2008
FOSAMAX
AB + MERCK AND CO INC EQ 70MG BASE N020560 005 Oct 20, 2000
TABLET, EFFERVESCENT;ORAL
BINOSTO
+ MISSION PHARMA EQ 70MG BASE N202344 001 Mar 12, 2012
ALENDRONATE SODIUM; CHOLECALCIFEROL
TABLET;ORAL
FOSAMAX PLUS D
MERCK EQ 70MG BASE;2,800 IU N021762 001 Apr 07, 2005
+ EQ 70MG BASE;5,600 IU N021762 002 Apr 26, 2007
ALFENTANIL HYDROCHLORIDE
INJECTABLE;INJECTION
ALFENTA
AP + AKORN EQ 0.5MG BASE/ML N019353 001 Dec 29, 1986
ALFENTANIL
AP HOSPIRA EQ 0.5MG BASE/ML A075221 001 Oct 28, 1999
ALFUZOSIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ALFUZOSIN HYDROCHLORIDE
AB APOTEX INC 10MG A079013 001 Jul 18, 2011
AB AUROBINDO PHARMA LTD 10MG A079060 001 Aug 30, 2012
AB INVAGEN PHARMS 10MG A090284 001 Jan 17, 2012
AB MYLAN 10MG A079014 001 Jul 18, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-12( of 362)
ALFUZOSIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ALFUZOSIN HYDROCHLORIDE
AB SUN PHARMA GLOBAL 10MG A079057 001 Jul 18, 2011
AB TEVA PHARMS 10MG A079056 001 Jul 18, 2011
AB TORRENT PHARMS 10MG A079054 001 Jul 18, 2011
AB WOCKHARDT LTD 10MG A090221 001 Aug 10, 2012
UROXATRAL
AB + COVIS PHARMA SARL 10MG N021287 001 Jun 12, 2003
ALISKIREN HEMIFUMARATE
TABLET;ORAL
TEKTURNA
NOVARTIS EQ 150MG BASE N021985 001 Mar 05, 2007
+ EQ 300MG BASE N021985 002 Mar 05, 2007
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
TABLET;ORAL
TEKAMLO
NOVARTIS EQ 150MG BASE;EQ 5MG BASE N022545 001 Aug 26, 2010
EQ 150MG BASE;EQ 10MG BASE N022545 002 Aug 26, 2010
EQ 300MG BASE;EQ 5MG BASE N022545 003 Aug 26, 2010
+ EQ 300MG BASE;EQ 10MG BASE N022545 004 Aug 26, 2010
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
AMTURNIDE
NOVARTIS EQ 150MG BASE;EQ 5MG BASE;12.5MG N200045 001 Dec 21, 2010
EQ 300MG BASE;EQ 5MG BASE;12.5MG N200045 002 Dec 21, 2010
EQ 300MG BASE;EQ 5MG BASE;25MG N200045 003 Dec 21, 2010
EQ 300MG BASE;EQ 10MG BASE;12.5MG N200045 004 Dec 21, 2010
+ EQ 300MG BASE;EQ 10MG BASE;25MG N200045 005 Dec 21, 2010
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
TEKTURNA HCT
NOVARTIS EQ 150MG BASE;12.5MG N022107 001 Jan 18, 2008
EQ 150MG BASE;25MG N022107 002 Jan 18, 2008
+ EQ 300MG BASE;12.5MG N022107 003 Jan 18, 2008
+ EQ 300MG BASE;25MG N022107 004 Jan 18, 2008
ALISKIREN HEMIFUMARATE; VALSARTAN
TABLET;ORAL
VALTURNA
NOVARTIS EQ 150MG BASE;160MG N022217 001 Sep 16, 2009
+ EQ 300MG BASE;320MG N022217 002 Sep 16, 2009
ALITRETINOIN
GEL;TOPICAL
PANRETIN
+ EISAI INC EQ 0.1% BASE N020886 001 Feb 02, 1999
ALLOPURINOL
TABLET;ORAL
ALLOPURINOL
AB ACCORD HLTHCARE 100MG A203154 001 May 06, 2013
AB 300MG A203154 002 May 06, 2013
AB APOTEX INC 100MG A077353 001 Sep 08, 2005
AB 300MG A077353 002 Sep 08, 2005
AB CARACO 100MG A078390 001 Aug 30, 2007
AB 300MG A078390 002 Aug 30, 2007
AB IPCA LABS LTD 100MG A090637 001 Mar 16, 2011
AB 300MG A090637 002 Mar 16, 2011
AB MUTUAL PHARM 100MG A071449 001 Jan 09, 1987
AB 300MG A071450 001 Jan 09, 1987
AB MYLAN 100MG A018659 001 Oct 24, 1986
AB 300MG A018659 002 Oct 24, 1986
AB NORTHSTAR HLTHCARE 100MG A078253 001 Sep 11, 2007
AB 300MG A078253 002 Sep 11, 2007
AB VINTAGE PHARMS 100MG A075798 001 Jun 27, 2003
AB 300MG A075798 002 Jun 27, 2003
AB WATSON LABS 100MG N018832 002 Sep 28, 1984
AB 300MG N018877 001 Sep 28, 1984
LOPURIN
AB DR REDDYS LA 100MG A071586 001 Apr 02, 1987
AB 300MG A071587 001 Apr 02, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-13( of 362)
ALLOPURINOL
TABLET;ORAL
ZYLOPRIM
AB PROMETHEUS LABS 100MG N016084 001
AB + 300MG N016084 002
ALLOPURINOL SODIUM
INJECTABLE;INJECTION
ALLOPURINOL SODIUM
AP BEDFORD LABS EQ 500MG BASE/VIAL A076870 001 Aug 26, 2004
ALOPRIM
AP + MYLAN INSTITUTIONAL EQ 500MG BASE/VIAL N020298 001 May 17, 1996
ALMOTRIPTAN MALATE
TABLET;ORAL
AXERT
JANSSEN PHARMS EQ 6.25MG BASE N021001 001 May 07, 2001
+ EQ 12.5MG BASE N021001 002 May 07, 2001
ALOGLIPTIN BENZOATE
TABLET;ORAL
NESINA
TAKEDA PHARMS USA EQ 6.25MG BASE N022271 001 Jan 25, 2013
EQ 12.5MG BASE N022271 002 Jan 25, 2013
+ EQ 25MG BASE N022271 003 Jan 25, 2013
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
KAZANO
+ TAKEDA PHARMS USA EQ 12.5MG BASE;1GM N203414 002 Jan 25, 2013
EQ 12.5MG BASE;500MG N203414 001 Jan 25, 2013
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
TABLET;ORAL
OSENI
TAKEDA PHARMS USA EQ 12.5MG BASE;EQ 15MG BASE N022426 004 Jan 25, 2013
EQ 12.5MG BASE;EQ 30MG BASE N022426 005 Jan 25, 2013
EQ 12.5MG BASE;EQ 45MG BASE N022426 006 Jan 25, 2013
EQ 25MG BASE;EQ 15MG BASE N022426 001 Jan 25, 2013
EQ 25MG BASE;EQ 30MG BASE N022426 002 Jan 25, 2013
+ EQ 25MG BASE;EQ 45MG BASE N022426 003 Jan 25, 2013
ALOSETRON HYDROCHLORIDE
TABLET;ORAL
LOTRONEX
PROMETHEUS LABS EQ 0.5MG BASE N021107 002 Dec 23, 2003
+ EQ 1MG BASE N021107 001 Feb 09, 2000
ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL;
FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE
HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K
INJECTABLE;INJECTION
INFUVITE ADULT
+ SANDOZ 2 IU/ML;40MG/ML;12MCG/ML;40 N021163 001 May 18, 2000
IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1
.2MG/ML;0.72MG/ML;1.2MG/ML;660
IU/ML;0.03MG/ML
INJECTABLE;IV (INFUSION)
INFUVITE ADULT
+ SANDOZ 2 IU/ML;40MG/ML;12MCG/ML;40 N021559 001 Jun 16, 2003
IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1
.2MG/ML;0.72MG/ML;1.2MG/ML;660
IU/ML;30MCG/ML
ALPRAZOLAM
CONCENTRATE;ORAL
ALPRAZOLAM
+ ROXANE 1MG/ML A074312 001 Oct 31, 1993
TABLET;ORAL
ALPRAZOLAM
AB ACTAVIS ELIZABETH 0.25MG A074342 001 Oct 31, 1993
AB 0.5MG A074342 002 Oct 31, 1993
AB 1MG A074342 003 Oct 31, 1993
AB 2MG A074342 004 Oct 31, 1993
AB APOTEX INC 0.25MG A077741 001 Jan 19, 2007
AB 0.5MG A077741 002 Jan 19, 2007
AB 1MG A077741 003 Jan 19, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-14( of 362)
ALPRAZOLAM
TABLET;ORAL
ALPRAZOLAM
AB 2MG A077741 004 Jan 19, 2007
AB BOCA PHARMA LLC 0.25MG A090248 001 Sep 17, 2010
AB 0.5MG A090248 002 Sep 17, 2010
AB 1MG A090248 003 Sep 17, 2010
AB 2MG A090248 004 Sep 17, 2010
AB DAVA INTL INC 0.25MG A074174 001 Oct 19, 1993
AB 0.5MG A074174 002 Oct 19, 1993
AB 1MG A074174 003 Oct 19, 1993
AB 2MG A074174 004 Oct 19, 1993
AB MYLAN 0.25MG A074215 001 Jan 27, 1994
AB 0.5MG A074215 002 Jan 27, 1994
AB 1MG A074215 003 Jan 27, 1994
AB 2MG A074215 004 Jan 27, 1994
AB MYLAN PHARMS INC 0.25MG A074046 001 Oct 19, 1993
AB 0.5MG A074046 002 Oct 19, 1993
AB 1MG A074046 003 Oct 19, 1993
AB 2MG A074046 004 May 07, 1997
AB SANDOZ 0.25MG A074112 001 Dec 29, 1995
AB 0.5MG A074112 002 Dec 29, 1995
AB 1MG A074112 003 Dec 29, 1995
AB 2MG A074909 001 Mar 25, 1998
AB SUN PHARMA GLOBAL 0.25MG A090082 001 Jun 17, 2010
AB 0.5MG A090082 002 Jun 17, 2010
AB 1MG A090082 003 Jun 17, 2010
AB 2MG A090082 004 Jun 17, 2010
AB VINTAGE 0.25MG A078491 001 Sep 25, 2008
AB 0.5MG A078491 002 Sep 25, 2008
AB 1MG A078491 003 Sep 25, 2008
AB 2MG A078491 004 Dec 12, 2008
XANAX
AB PHARMACIA AND UPJOHN 0.25MG N018276 001
AB 0.5MG N018276 002
AB + 1MG N018276 003
AB 2MG N018276 004 Nov 27, 1985
TABLET, EXTENDED RELEASE;ORAL
ALPRAZOLAM
AB ACTAVIS ELIZABETH 0.5MG A078056 001 Feb 13, 2007
AB 1MG A078056 002 Feb 13, 2007
AB 2MG A078056 003 Feb 13, 2007
AB 3MG A078056 004 Feb 13, 2007
AB AMNEAL PHARMS NY 0.5MG A078387 001 May 30, 2008
AB 1MG A078387 002 May 30, 2008
AB 2MG A078387 003 May 30, 2008
AB 3MG A078387 004 May 30, 2008
AB ANCHEN PHARMS 0.5MG A078469 001 Sep 29, 2011
AB 1MG A078469 002 Sep 29, 2011
AB 2MG A078469 003 Sep 29, 2011
AB 3MG A078469 004 Sep 29, 2011
AB APOTEX INC 0.5MG A078449 001 Nov 12, 2008
AB 2MG A078449 002 Nov 12, 2008
AB 3MG A078449 003 Nov 12, 2008
AB AUROBINDO PHARMA USA 0.5MG A090871 001 Jun 07, 2011
AB 1MG A090871 002 Jun 07, 2011
AB 2MG A090871 003 Jun 07, 2011
AB 3MG A090871 004 Jun 07, 2011
AB BARR 0.5MG A077725 001 Jul 31, 2006
AB 1MG A077725 002 Jul 31, 2006
AB 2MG A077725 004 Jul 31, 2006
AB 3MG A077725 003 Jul 31, 2006
AB COREPHARMA 0.5MG A077996 001 Jan 31, 2007
AB 1MG A077996 002 Jan 31, 2007
AB 2MG A077996 003 Jan 31, 2007
AB 3MG A077996 004 Jan 31, 2007
AB IMPAX LABS 0.5MG A077968 004 May 24, 2007
AB 1MG A077968 003 May 24, 2007
AB 2MG A077968 002 May 24, 2007
AB 3MG A077968 001 May 24, 2007
AB MYLAN 0.5MG A077391 002 Jan 26, 2006
AB 1MG A077391 003 Jan 26, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-15( of 362)
ALPRAZOLAM
TABLET, EXTENDED RELEASE;ORAL
ALPRAZOLAM
AB 2MG A077391 004 Jan 26, 2006
AB 3MG A077391 001 Jan 26, 2006
AB WATSON LABS FLORIDA 0.5MG A077198 001 May 13, 2010
AB 1MG A077198 002 May 13, 2010
AB 2MG A077198 003 May 13, 2010
AB 3MG A077198 004 May 13, 2010
AB ZYDUS PHARMS USA INC 0.5MG A078489 001 Oct 17, 2008
AB 1MG A078489 002 Oct 17, 2008
AB 2MG A078489 003 Oct 17, 2008
AB 3MG A078489 004 Oct 17, 2008
XANAX XR
AB PHARMACIA AND UPJOHN 0.5MG N021434 001 Jan 17, 2003
AB 1MG N021434 002 Jan 17, 2003
AB 2MG N021434 003 Jan 17, 2003
AB + 3MG N021434 004 Jan 17, 2003
TABLET, ORALLY DISINTEGRATING;ORAL
ALPRAZOLAM
AB ACTAVIS ELIZABETH 0.25MG A078561 001 Mar 16, 2010
AB 0.5MG A078561 002 Mar 16, 2010
AB 1MG A078561 003 Mar 16, 2010
AB 2MG A078561 004 Mar 16, 2010
AB PAR PHARM 0.25MG A078088 001 Jan 09, 2009
AB 0.5MG A078088 002 Jan 09, 2009
AB 1MG A078088 003 Jan 09, 2009
AB 2MG A078088 004 Jan 09, 2009
NIRAVAM
AB UCB INC 0.25MG N021726 001 Jan 19, 2005
AB 0.5MG N021726 002 Jan 19, 2005
AB + 1MG N021726 003 Jan 19, 2005
AB 2MG N021726 004 Jan 19, 2005
ALPROSTADIL
INJECTABLE;INJECTION
ALPROSTADIL
AP BEDFORD 0.5MG/ML A074815 001 Jan 20, 1998
AP TEVA PHARMS USA 0.5MG/ML A075196 001 Apr 30, 1999
CAVERJECT
AP PHARMACIA AND UPJOHN 0.01MG/VIAL N020379 001 Jul 06, 1995
AP + 0.02MG/VIAL N020379 002 Jul 06, 1995
AP + 0.04MG/VIAL N020379 004 May 19, 1997
EDEX
AP ACTIENT PHARMS 0.01MG/VIAL N020649 002 Jun 12, 1997
AP 0.02MG/VIAL N020649 003 Jun 12, 1997
AP + 0.04MG/VIAL N020649 004 Jun 12, 1997
PROSTIN VR PEDIATRIC
AP + PHARMACIA AND UPJOHN 0.5MG/ML N018484 001
CAVERJECT
PHARMACIA AND UPJOHN 0.005MG/VIAL N020379 003 Jun 27, 1996
CAVERJECT IMPULSE
PHARMACIA AND UPJOHN 0.01MG/VIAL N021212 001 Jun 11, 2002
0.02MG/VIAL N021212 002 Jun 11, 2002
EDEX
+ ACTIENT PHARMS 0.01MG/VIAL N020649 005 Jul 30, 1998
+ 0.02MG/VIAL N020649 006 Jul 30, 1998
+ 0.04MG/VIAL N020649 007 Jul 30, 1998
SUPPOSITORY;URETHRAL
MUSE
MEDA PHARMS 0.125MG N020700 001 Nov 19, 1996
0.25MG N020700 002 Nov 19, 1996
0.5MG N020700 003 Nov 19, 1996
+ 1MG N020700 004 Nov 19, 1996
ALTRETAMINE
CAPSULE;ORAL
HEXALEN
+ EISAI INC 50MG N019926 001 Dec 26, 1990
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-16( of 362)
ALVIMOPAN
CAPSULE;ORAL
ENTEREG
+ CUBIST PHARMS 12MG N021775 001 May 20, 2008
AMANTADINE HYDROCHLORIDE
CAPSULE;ORAL
AMANTADINE HYDROCHLORIDE
AB BANNER PHARMACAPS 100MG A078720 001 May 29, 2008
AB SANDOZ 100MG A071293 001 Feb 18, 1987
AB + USL PHARMA 100MG A070589 001 Aug 05, 1986
SYRUP;ORAL
AMANTADINE HYDROCHLORIDE
AA + CAROLINA MEDCL 50MG/5ML A075819 001 Sep 11, 2002
AA + HI TECH PHARMA 50MG/5ML A074170 001 Oct 28, 1994
AA + MIKART 50MG/5ML A074028 001 Jun 28, 1993
AA + PHARM ASSOC 50MG/5ML A074509 001 Jul 17, 1995
AA + SILARX 50MG/5ML A076352 001 Sep 10, 2004
AA + VINTAGE 50MG/5ML A077992 001 Dec 12, 2006
AA + WOCKHARDT 50MG/5ML A075060 001 Dec 24, 1998
TABLET;ORAL
AMANTADINE HYDROCHLORIDE
+ USL PHARMA 100MG A076186 001 Dec 16, 2002
AMBENONIUM CHLORIDE
TABLET;ORAL
MYTELASE
+ SANOFI AVENTIS US 10MG N010155 002
AMBRISENTAN
TABLET;ORAL
LETAIRIS
GILEAD 5MG N022081 001 Jun 15, 2007
+ 10MG N022081 002 Jun 15, 2007
AMCINONIDE
CREAM;TOPICAL
AMCINONIDE
AB + FOUGERA PHARMS 0.1% A076065 001 May 15, 2003
AB TARO PHARM INDS 0.1% A076229 001 May 31, 2002
LOTION;TOPICAL
AMCINONIDE
+ FOUGERA PHARMS 0.1% A076329 001 Nov 06, 2002
OINTMENT;TOPICAL
AMCINONIDE
AB + FOUGERA PHARMS 0.1% A076096 001 Nov 19, 2002
AB TARO PHARM INDS 0.1% A076367 001 Mar 19, 2003
AMIFOSTINE
INJECTABLE;INJECTION
AMIFOSTINE
AP SUN PHARMA GLOBAL 500MG/VIAL A077126 001 Mar 14, 2008
ETHYOL
AP + MEDIMMUNE 500MG/VIAL N020221 001 Dec 08, 1995
AMIKACIN SULFATE
INJECTABLE;INJECTION
AMIKACIN SULFATE
AP + BEDFORD EQ 50MG BASE/ML A063313 001 Apr 11, 1994
AP + EQ 250MG BASE/ML A063315 001 Apr 11, 1994
AP EMCURE PHARMS LTD EQ 250MG BASE/ML A204040 001 Dec 12, 2013
AP TEVA PHARMS USA EQ 250MG BASE/ML A064045 002 Sep 28, 1993
AMILORIDE HYDROCHLORIDE
TABLET;ORAL
AMILORIDE HYDROCHLORIDE
AB + PAR PHARM 5MG A070346 001 Jan 22, 1986
AB SIGMAPHARM LABS LLC 5MG A079133 001 Jan 30, 2009
MIDAMOR
AB PADDOCK LLC 5MG N018200 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB BARR
AB + MYLAN
AMINO ACIDS
INJECTABLE;INJECTION
AMINO ACIDS
B BRAUN
AMINOSYN 10%
HOSPIRA
AMINOSYN 10% (PH6)
HOSPIRA
AMINOSYN 3.5%
HOSPIRA
AMINOSYN 5%
HOSPIRA
AMINOSYN 7%
HOSPIRA
AMINOSYN 7% (PH6)
HOSPIRA
AMINOSYN 8.5%
HOSPIRA
AMINOSYN 8.5% (PH6)
HOSPIRA
AMINOSYN II 10%
HOSPIRA
AMINOSYN II 10% IN PLASTIC CONTAINER
HOSPIRA 10% (10GM/100ML)
AMINOSYN II 15% IN PLASTIC CONTAINER
BRANCHAMIN 4% IN PLASTIC CONTAINER
HOSPIRA
AMINOSYN II 7%
15% (15GM/100ML)
HOSPIRA
AMINOSYN II 8.5%
7% (7GM/100ML)
HOSPIRA
AMINOSYN-HBC 7%
8.5% (8.5GM/100ML)
HOSPIRA
AMINOSYN-HF 8%
7% (7GM/100ML)
HOSPIRA
AMINOSYN-PF 10%
8% (8GM/100ML)
HOSPIRA
AMINOSYN-PF 7%
10% (10GM/100ML)
HOSPIRA
AMINOSYN-RF 5.2%
7% (7GM/100ML)
HOSPIRA 5.2% (5.2GM/100ML)
BAXTER HLTHCARE 4% (4GM/100ML)
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER
BAXTER HLTHCARE
FREAMINE HBC 6.9%
B BRAUN
FREAMINE III 10%
B BRAUN
FREAMINE III 8.5%
B BRAUN
HEPATAMINE 8%
B BRAUN
HEPATASOL 8%
BAXTER HLTHCARE
NEPHRAMINE 5.4%
B BRAUN
EQ 5MG ANHYDROUS;50MG
EQ 5MG ANHYDROUS;50MG
15%(150GM/1000ML)
15%(300GM/2000ML)
10% (10GM/100ML)
10% (10GM/100ML)
3.5% (3.5GM/100ML)
5% (5GM/100ML)
7% (7GM/100ML)
7% (7GM/100ML)
8.5% (8.5GM/100ML)
8.5% (8.5GM/100ML)
10% (10GM/100ML)
PREMASOL 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 10% (10GM/100ML)
PREMASOL 6% IN PLASTIC CONTAINER
BAXTER HLTHCARE 6% (6GM/100ML)
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 20% (20GM/100ML)
RENAMIN W/O ELECTROLYTES
BAXTER HLTHCARE 6.5% (6.5GM/100ML)
15% (15GM/100ML)
6.9% (6.9GM/100ML)
10% (10GM/100ML)
8.5% (8.5GM/100ML)
8% (8GM/100ML)
8% (8GM/100ML)
5.4% (5.4GM/100ML)
3-17( of 362)
A071111 001 May 10, 1988
A073209 001 Oct 31, 1991
A091112 001 Apr 13, 2012
A091112 002 Apr 13, 2012
N017673 003
N017673 008 Nov 18, 1985
N017789 004
N017673 001
N017673 002
N017673 006 Nov 18, 1985
N017673 004
N017673 007 Nov 18, 1985
N019438 005 Apr 03, 1986
N020015 001 Dec 19, 1991
N020041 001 Dec 19, 1991
N019438 003 Apr 03, 1986
N019438 004 Apr 03, 1986
N019374 001 Jul 12, 1985
A020345 001 Apr 04, 1996
N019492 002 Oct 17, 1986
N019398 001 Sep 06, 1985
N018429 001
N018684 001 Sep 28, 1984
A020512 001 Aug 30, 1996
N016822 006 May 17, 1983
N016822 005
N016822 004
N018676 001 Aug 03, 1982
A020360 001 Apr 04, 1996
N017766 001
A075880 002 Jun 19, 2003
A075880 001 Jun 19, 2003
N020849 001 Aug 26, 1998
N017493 007 Oct 15, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-18( of 362)
AMINO ACIDS
INJECTABLE;INJECTION
TRAVASOL 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 10% (10MG/100ML) N018931 003 Aug 23, 1984
TRAVASOL 10% W/O ELECTROLYTES
BAXTER HLTHCARE 10% (10GM/100ML) N017493 006
TRAVASOL 5.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5.5% (5.5GM/100ML) N018931 001 Aug 23, 1984
TRAVASOL 5.5% W/O ELECTROLYTES
BAXTER HLTHCARE 5.5% (5.5GM/100ML) N017493 004
TRAVASOL 8.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 8.5% (8.5GM/100ML) N018931 002 Aug 23, 1984
TRAVASOL 8.5% W/O ELECTROLYTES
BAXTER HLTHCARE 8.5% (8.5GM/100ML) N017493 005
TROPHAMINE
+ B BRAUN 6% (6GM/100ML) N019018 001 Jul 20, 1984
TROPHAMINE 10%
+ B BRAUN 10% (10GM/100ML) N019018 003 Sep 07, 1988
AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE;
SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
PROCALAMINE
B BRAUN 3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG N018582 001 May 08, 1982
/100ML;150MG/100ML;200MG/100ML;120MG/10
0ML
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM
ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 2.75%;33MG/100ML;10GM/100ML;51MG/100ML; N020678 002 Mar 26, 1997
261MG/100ML;217MG/100ML;112MG/100ML
CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 2.75%;33MG/100ML;25GM/100ML;51MG/100ML; N020678 005 Mar 26, 1997
261MG/100ML;217MG/100ML;112MG/100ML
CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 2.75%;33MG/100ML;5GM/100ML;51MG/100ML;2 N020678 001 Mar 26, 1997
61MG/100ML;217MG/100ML;112MG/100ML
CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 4.25%;33MG/100ML;10GM/100ML;51MG/100ML; N020678 009 Mar 26, 1997
261MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 4.25%;33MG/100ML;20GM/100ML;51MG/100ML; N020678 011 Mar 26, 1997
261MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 4.25%;33MG/100ML;25GM/100ML;51MG/100ML; N020678 012 Mar 26, 1997
261MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 4.25%;33MG/100ML;5GM/100ML;51MG/100ML;2 N020678 008 Mar 26, 1997
61MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 5%;33MG/100ML;10GM/100ML;51MG/100ML;261 N020678 016 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 5%;33MG/100ML;15GM/100ML;51MG/100ML;261 N020678 017 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 5%;33MG/100ML;20GM/100ML;51MG/100ML;261 N020678 018 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 5%;33MG/100ML;25GM/100ML;51MG/100ML;261 N020678 019 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 5%;33MG/100ML;35GM/100ML;51MG/100ML;261 N020678 021 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
AMINO ACIDS; DEXTROSE
INJECTABLE;INJECTION
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;10GM/100ML N020734 002 Sep 29, 1997
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;25GM/100ML N020734 005 Sep 29, 1997
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;5GM/100ML N020734 001 Sep 29, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
AMINO ACIDS; DEXTROSE
INJECTABLE;INJECTION
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;10GM/100ML
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;20GM/100ML
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;25GM/100ML
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;5GM/100ML
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5%;10GM/100ML
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5%;15GM/100ML
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5%;20GM/100ML
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5%;25GM/100ML
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5%;35GM/100ML
N020734 008
N020734 010
N020734 011
N020734 007
N020734 014
N020734 015
N020734 016
N020734 017
N020734 018
3-19( of 362)
Sep 29, 1997
Sep 29, 1997
Sep 29, 1997
Sep 29, 1997
Sep 29, 1997
Sep 29, 1997
Sep 29, 1997
Sep 29, 1997
Sep 29, 1997
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM
ACETATE
INJECTABLE;INJECTION
FREAMINE III 8.5% W/ ELECTROLYTES
B BRAUN 8.5%;110MG/100ML;230MG/100ML;10MG/100ML N016822 007 Jul 01, 1988
;440MG/100ML;690MG/100ML
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN 3.5% M
HOSPIRA 3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N017789 003
234MG/100ML
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE
INJECTABLE;INJECTION
FREAMINE III 3% W/ ELECTROLYTES
B BRAUN 3%;54MG/100ML;40MG/100ML;150MG/100ML;20 N016822 003
0MG/100ML;120MG/100ML
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN II 10% W/ ELECTROLYTES
HOSPIRA 10%;102MG/100ML;45MG/100ML;522MG/100ML; N019437 004 Apr 03, 1986
410MG/100ML
AMINOSYN II 8.5% W/ ELECTROLYTES
HOSPIRA 8.5%;102MG/100ML;45MG/100ML;522MG/100ML N019437 005 Apr 03, 1986
;410MG/100ML
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
BAXTER HLTHCARE 3.5%;51MG/100ML;131MG/100ML;218MG/100ML
;35MG/100ML
TRAVASOL 3.5% W/ ELECTROLYTES
BAXTER HLTHCARE 3.5%;51MG/100ML;131MG/100ML;218MG/100ML
;35MG/100ML
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
BAXTER HLTHCARE 5.5%;102MG/100ML;522MG/100ML;431MG/100M
L;224MG/100ML
TRAVASOL 5.5% W/ ELECTROLYTES
BAXTER HLTHCARE 5.5%;102MG/100ML;522MG/100ML;431MG/100M
L;224MG/100ML
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
BAXTER HLTHCARE 8.5%;102MG/100ML;522MG/100ML;594MG/100M
L;154MG/100ML
TRAVASOL 8.5% W/ ELECTROLYTES
BAXTER HLTHCARE 8.5%;102MG/100ML;522MG/100ML;594MG/100M
L;154MG/100ML
N020177 001 Oct 23, 1995
N017493 003
N020173 001 Oct 27, 1995
N017493 001
N020173 002 Oct 27, 1995
N017493 002
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN 7% W/ ELECTROLYTES
HOSPIRA 7%;102MG/100ML;522MG/100ML;410MG/100ML N017789 002
AMINOSYN 8.5% W/ ELECTROLYTES
HOSPIRA 8.5%;102MG/100ML;522MG/100ML;410MG/100M N017673 005
L
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-20( of 362)
AMINOCAPROIC ACID
INJECTABLE;INJECTION
AMINOCAPROIC ACID
AP LUITPOLD 250MG/ML A071192 001 Dec 01, 1987
AMINOCAPROIC ACID IN PLASTIC CONTAINER
AP + HOSPIRA 250MG/ML A070010 001 Mar 09, 1987
SYRUP;ORAL
AMICAR
AA + CLOVER PHARMS 1.25GM/5ML N015230 002
AMINOCAPROIC ACID
AA MIKART 1.25GM/5ML A074759 001 Sep 02, 1998
TABLET;ORAL
AMICAR
AB CLOVER PHARMS 500MG N015197 001
AMINOCAPROIC
AB MIKART 500MG A075602 001 May 24, 2001
AMICAR
+ CLOVER PHARMS 1GM N015197 002 Jun 24, 2004
AMINOHIPPURATE SODIUM
INJECTABLE;INJECTION
AMINOHIPPURATE SODIUM
+ MERCK 20% N005619 001
AMINOLEVULINIC ACID HYDROCHLORIDE
SOLUTION;TOPICAL
LEVULAN
+ DUSA 20% N020965 001 Dec 03, 1999
AMINOPHYLLINE
INJECTABLE;INJECTION
AMINOPHYLLINE
AP + HOSPIRA 25MG/ML A087242 001 Oct 26, 1983
AP LUITPOLD 25MG/ML A087600 001
AMINOSALICYLIC ACID
GRANULE, DELAYED RELEASE;ORAL
PASER
+ JACOBUS 4GM/PACKET A074346 001 Jun 30, 1994
AMIODARONE HYDROCHLORIDE
INJECTABLE;INJECTION
AMIODARONE HYDROCHLORIDE
AP + AKORN 50MG/ML A076232 001 Jul 05, 2006
AP + FRESENIUS KABI USA 50MG/ML A075761 001 Oct 15, 2002
AP + GLAND PHARMA LTD 50MG/ML A077161 001 Apr 20, 2005
AP HIKMA FARMACEUTICA 50MG/ML A077234 001 Feb 25, 2008
AP + HOSPIRA 50MG/ML A075955 001 Oct 18, 2002
AP HOSPIRA INC 50MG/ML A203884 001 Nov 25, 2013
AP 50MG/ML A203885 001 Nov 25, 2013
AP + MYLAN INSTITUTIONAL 50MG/ML A076217 001 Oct 15, 2002
AP WOCKHARDT 50MG/ML A077610 001 Oct 30, 2008
AP 50MG/ML A077834 001 Oct 30, 2008
NEXTERONE
AP BAXTER HLTHCARE 50MG/ML N022325 001 Dec 24, 2008
+ 150MG/100ML (1.5MG/ML) N022325 002 Nov 16, 2010
+ 360MG/200ML (1.8MG/ML) N022325 003 Nov 16, 2010
TABLET;ORAL
AMIODARONE HYDROCHLORIDE
AB APOTEX CORP 200MG A078578 001 Nov 06, 2008
AB BARR 200MG A075389 001 Jan 25, 2001
AB MURTY PHARMS 200MG A077069 001 Apr 08, 2005
AB 400MG A077069 002 Apr 08, 2005
AB MYLAN 200MG A075188 001 Feb 24, 1999
AB SANDOZ 200MG A075315 001 Dec 23, 1998
AB 400MG A075315 002 Jun 30, 2000
AB TARO 100MG A075424 002 Dec 18, 2002
AB 200MG A075424 001 Mar 30, 2001
AB 400MG A076362 001 Nov 29, 2002
AB TEVA PHARMS 200MG A074739 001 Nov 30, 1998
AB ZYDUS PHARMS USA INC 200MG A079029 001 Sep 16, 2008
CORDARONE
AB + WYETH PHARMS INC 200MG N018972 001 Dec 24, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
AMIODARONE HYDROCHLORIDE
TABLET;ORAL
PACERONE
AB UPSHER SMITH
AB
AMIODARONE HYDROCHLORIDE
TARO
AMITRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
AMITRIPTYLINE HYDROCHLORIDE
AB CARACO
AB
AB
AB
AB
AB
AB MUTUAL PHARM
AB
AB
AB
AB
AB
AB MYLAN
AB
AB
AB
AB
AB
AB SANDOZ
AB +
AB
AB
AB
AB
AB VINTAGE PHARMS
AB
AB
AB
AB
AB
100MG
200MG
300MG
10MG
25MG
50MG
75MG
100MG
150MG
10MG
25MG
50MG
75MG
100MG
150MG
10MG
25MG
50MG
75MG
100MG
150MG
10MG
25MG
50MG
75MG
100MG
150MG
10MG
25MG
50MG
75MG
100MG
150MG
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
TABLET;ORAL
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
MYLAN PHARMS INC EQ 12.5MG BASE;5MG
+ EQ 25MG BASE;10MG
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
TABLET;ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
MYLAN
+
+
+
AMLODIPINE BESYLATE
TABLET;ORAL
AMLODIPINE BESYLATE
AB ACCORD HLTHCARE
AB
AB
AB ALKEM
AB
AB
AB AMNEAL PHARMS NY
AB
AB
AB APOTEX
AB
AB
AB AUROBINDO PHARMA
AB
10MG;2MG
10MG;4MG
25MG;2MG
25MG;4MG
50MG;4MG
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
3-21( of 362)
A075135 002 Apr 12, 2005
A075135 001 Apr 30, 1998
A076362 002 Dec 02, 2003
A040816 002 Jun 27, 2008
A040816 001 Jun 27, 2008
A040816 003 Jun 27, 2008
A040816 004 Jun 27, 2008
A040816 005 Jun 27, 2008
A040816 006 Jun 27, 2008
A089398 001 Jul 14, 1987
A089399 001 Jul 14, 1987
A089400 001 Jul 14, 1987
A089401 001 Jul 14, 1987
A089402 001 Jul 14, 1987
A089403 001 Jul 14, 1987
A086009 002
A086009 003
A086009 001
A086009 004
A086009 005
A086009 006
A085969 001
A085966 001
A085968 001
A085971 001
A085967 001
A085970 001
A040218 001 Sep 11, 1997
A040218 002 Sep 11, 1997
A040218 003 Sep 11, 1997
A040218 004 Sep 11, 1997
A040218 005 Sep 11, 1997
A040218 006 Sep 11, 1997
A071297 002 Dec 10, 1986
A071297 001 Dec 10, 1986
A071443 002 Nov 10, 1988
A071443 003 Nov 10, 1988
A071443 004 Nov 10, 1988
A071443 005 Nov 10, 1988
A071443 001 Nov 10, 1988
A202553 001 Apr 29, 2013
A202553 002 Apr 29, 2013
A202553 003 Apr 29, 2013
A078925 001 May 04, 2009
A078925 002 May 04, 2009
A078925 003 May 04, 2009
A078477 001 Jan 16, 2008
A078477 002 Jan 16, 2008
A078477 003 Jan 16, 2008
A076719 001 May 23, 2007
A076719 002 May 23, 2007
A076719 003 May 23, 2007
A078021 001 Jul 17, 2007
A078021 002 Jul 17, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
AMLODIPINE BESYLATE
TABLET;ORAL
AMLODIPINE BESYLATE
AB
AB CARACO
AB
AB
AB CIPLA LTD
AB
AB
AB DR REDDYS LABS LTD
AB
AB
AB EPIC PHARMA LLC
AB
AB
AB HIKMA PHARMS
AB
AB
AB INVAGEN PHARMS
AB
AB
AB LUPIN
AB
AB
AB MACLEODS PHARMS LTD
AB
AB MATRIX LABS LTD
AB
AB
AB MYLAN
AB
AB
AB ORCHID HLTHCARE
AB
AB
AB PURACAP PHARM
AB
AB
AB RANBAXY
AB
AB
AB ROXANE
AB
AB
AB SECAN PHARMS
AB
AB TEVA
AB
AB
AB TORRENT PHARMS
AB
AB
AB UNICHEM LABS LTD
AB
AB
AB UPSHER SMITH
AB
AB
AB VINTAGE
AB
AB
AB WATSON LABS
AB
AB
AB WOCKHARDT
AB
AB
AB WORLD GEN
AB
AB
AB ZYDUS PHARMS USA
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
3-22( of 362)
A078021 003 Jul 17, 2007
A078231 001 Nov 30, 2007
A078231 002 Nov 30, 2007
A078231 003 Nov 30, 2007
A077073 001 Sep 26, 2007
A077073 002 Sep 26, 2007
A077073 003 Sep 26, 2007
A076692 001 Jul 20, 2007
A076692 002 Jul 20, 2007
A076692 003 Jul 20, 2007
A078552 001 Apr 08, 2009
A078552 002 Apr 08, 2009
A078552 003 Apr 08, 2009
A077771 001 Apr 12, 2011
A077771 002 Apr 12, 2011
A077771 003 Apr 12, 2011
A077955 001 Aug 28, 2007
A077955 002 Aug 28, 2007
A077955 003 Aug 28, 2007
A078043 001 Jul 12, 2007
A078043 002 Jul 12, 2007
A078043 003 Jul 12, 2007
A201380 001 Apr 13, 2012
A201380 002 Apr 13, 2012
A078224 001 Feb 27, 2008
A078224 002 Feb 27, 2008
A078224 003 Feb 27, 2008
A076418 001 Oct 03, 2005
A076418 002 Oct 03, 2005
A076418 003 Oct 03, 2005
A078453 001 Jul 02, 2009
A078453 002 Jul 02, 2009
A078453 003 Jul 02, 2009
A078131 001 Sep 04, 2007
A078131 002 Sep 04, 2007
A078131 003 Sep 04, 2007
A077974 001 Jul 09, 2007
A077974 002 Jul 09, 2007
A077974 003 Jul 09, 2007
A077262 001 Jul 09, 2007
A077262 002 Jul 09, 2007
A077262 003 Jul 09, 2007
A090752 001 Apr 15, 2011
A090752 002 Apr 15, 2011
A076846 001 Jun 28, 2007
A076846 002 Jun 28, 2007
A076846 003 Jun 28, 2007
A078573 001 Sep 22, 2008
A078573 002 Sep 22, 2008
A078573 003 Sep 22, 2008
A203245 001 Oct 21, 2013
A203245 002 Oct 21, 2013
A203245 003 Oct 21, 2013
A077759 001 Jul 09, 2007
A077759 002 Jul 09, 2007
A077759 003 Jul 09, 2007
A078414 001 Apr 07, 2010
A078414 002 Apr 07, 2010
A078414 003 Apr 07, 2010
A077671 001 Jul 19, 2007
A077671 002 Jul 19, 2007
A077671 003 Jul 19, 2007
A078500 001 Sep 06, 2007
A078500 002 Sep 06, 2007
A078500 003 Sep 06, 2007
A077516 001 Jul 11, 2007
A077516 002 Jul 11, 2007
A077516 003 Jul 11, 2007
A078226 001 Jul 09, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
AMLODIPINE BESYLATE
TABLET;ORAL
AMLODIPINE BESYLATE
AB
AB
NORVASC
AB PFIZER
AB
AB +
PRESCRIPTION DRUG PRODUCT LIST
EQ 5MG BASE
EQ 10MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
TABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
AB MYLAN PHARMS INC EQ 2.5MG BASE;EQ 10MG BASE
AB EQ 2.5MG BASE;EQ 20MG BASE
AB EQ 2.5MG BASE;EQ 40MG BASE
AB EQ 5MG BASE;EQ 10MG BASE
AB EQ 5MG BASE;EQ 20MG BASE
AB EQ 5MG BASE;EQ 40MG BASE
AB EQ 5MG BASE;EQ 80MG BASE
AB EQ 10MG BASE;EQ 10MG BASE
AB EQ 10MG BASE;EQ 20MG BASE
AB EQ 10MG BASE;EQ 40MG BASE
AB EQ 10MG BASE;EQ 80MG BASE
CADUET
AB PFIZER EQ 2.5MG BASE;EQ 10MG BASE
AB EQ 2.5MG BASE;EQ 20MG BASE
AB EQ 2.5MG BASE;EQ 40MG BASE
AB EQ 5MG BASE;EQ 10MG BASE
AB EQ 5MG BASE;EQ 20MG BASE
AB EQ 5MG BASE;EQ 40MG BASE
AB EQ 5MG BASE;EQ 80MG BASE
AB EQ 10MG BASE;EQ 10MG BASE
AB EQ 10MG BASE;EQ 20MG BASE
AB EQ 10MG BASE;EQ 40MG BASE
AB + EQ 10MG BASE;EQ 80MG BASE
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
CAPSULE;ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
AB APOTEX INC
AB
AB
AB
AB
AB
AB AUROBINDO PHARMA LTD
AB
AB
AB
AB
AB
AB DR REDDYS LABS INC
AB
AB
AB
AB
AB
AB LUPIN PHARMS
AB
AB
AB
AB
AB
AB MYLAN
AB
AB
AB
AB
AB
AB PAR PHARM
AB
AB
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
3-23( of 362)
A078226 002 Jul 09, 2007
A078226 003 Jul 09, 2007
N019787 001 Jul 31, 1992
N019787 002 Jul 31, 1992
N019787 003 Jul 31, 1992
A200465 001 Nov 29, 2013
A200465 002 Nov 29, 2013
A200465 003 Nov 29, 2013
A200465 004 Nov 29, 2013
A200465 005 Nov 29, 2013
A200465 006 Nov 29, 2013
A200465 007 Nov 29, 2013
A200465 008 Nov 29, 2013
A200465 009 Nov 29, 2013
A200465 010 Nov 29, 2013
A200465 011 Nov 29, 2013
N021540 009 Jul 29, 2004
N021540 010 Jul 29, 2004
N021540 011 Jul 29, 2004
N021540 001 Jan 30, 2004
N021540 002 Jan 30, 2004
N021540 003 Jan 30, 2004
N021540 004 Jan 30, 2004
N021540 005 Jan 30, 2004
N021540 006 Jan 30, 2004
N021540 007 Jan 30, 2004
N021540 008 Jan 30, 2004
A091431 001 Dec 30, 2013
A091431 002 Dec 30, 2013
A091431 003 Dec 30, 2013
A091431 004 Dec 30, 2013
A091431 005 Dec 30, 2013
A091431 006 Dec 30, 2013
A202239 001 Sep 05, 2012
A202239 002 Sep 05, 2012
A202239 003 Sep 05, 2012
A202239 004 Sep 05, 2012
A202239 005 Sep 05, 2012
A202239 006 Sep 05, 2012
A077183 001 Apr 15, 2010
A077183 002 Apr 15, 2010
A077183 003 Apr 15, 2010
A090149 001 Jul 05, 2011
A077183 004 Apr 15, 2010
A090149 002 Jul 05, 2011
A078466 001 Feb 05, 2010
A078466 002 Feb 05, 2010
A078466 003 Feb 05, 2010
A078466 005 Jul 05, 2011
A078466 004 Feb 05, 2010
A078466 006 Jul 05, 2011
A077375 001 May 21, 2010
A077375 002 May 21, 2010
A077375 003 May 21, 2010
A079047 001 Jul 05, 2011
A077375 004 May 21, 2010
A079047 002 Jul 05, 2011
A078381 001 Jul 29, 2010
A078381 002 Jul 29, 2010
A078381 003 Jul 29, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
CAPSULE;ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
AB
AB
AB
AB TEVA PHARMS
AB
AB
AB
AB
AB
AB WATSON LABS
AB
AB
AB
AB WATSON LABS INC
AB
LOTREL
AB NOVARTIS
AB
AB
AB
AB
AB +
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 10MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
TABLET;ORAL
TRIBENZOR
DAIICHI SANKYO EQ 5MG BASE;12.5MG;20MG
EQ 5MG BASE;12.5MG;40MG
EQ 5MG BASE;25MG;40MG
EQ 10MG BASE;12.5MG;40MG
+ EQ 10MG BASE;25MG;40MG
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
TABLET;ORAL
EXFORGE HCT
AB
AB
AB
AB
AB +
NOVARTIS 5MG;12.5MG;160MG
5MG;25MG;160MG
10MG;12.5MG;160MG
10MG;25MG;160MG
10MG;25MG;320MG
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
TABLET;ORAL
AZOR
DAIICHI SANKYO EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
+ EQ 10MG BASE;40MG
AMLODIPINE BESYLATE; TELMISARTAN
TABLET;ORAL
TELMISARTAN AND AMLODIPINE
AB LUPIN LTD
AB
AB
AB
AB TORRENT PHARMS LTD
AB
AB
AB
TWYNSTA
AB BOEHRINGER INGELHEIM
AB
AB
AB +
EQ 5MG BASE;40MG
EQ 5MG BASE;80MG
EQ 10MG BASE;40MG
EQ 10MG BASE;80MG
EQ 5MG BASE;40MG
EQ 5MG BASE;80MG
EQ 10MG BASE;40MG
EQ 10MG BASE;80MG
EQ 5MG BASE;40MG
EQ 5MG BASE;80MG
EQ 10MG BASE;40MG
EQ 10MG BASE;80MG
3-24( of 362)
A078381 005 Jul 29, 2010
A078381 004 Jul 29, 2010
A078381 006 Jul 29, 2010
A077179 001 May 18, 2007
A077179 002 May 18, 2007
A077179 003 May 18, 2007
A077179 005 Jul 05, 2011
A077179 004 May 18, 2007
A077179 006 Jul 05, 2011
A077890 001 Oct 14, 2010
A077890 002 Oct 14, 2010
A077890 003 Oct 14, 2010
A077890 004 Oct 14, 2010
A090364 001 Jul 05, 2011
A090364 002 Jul 05, 2011
N020364 002 Mar 03, 1995
N020364 003 Mar 03, 1995
N020364 004 Mar 03, 1995
N020364 007 Apr 11, 2006
N020364 005 Jun 20, 2002
N020364 006 Apr 11, 2006
N200175 001 Jul 23, 2010
N200175 002 Jul 23, 2010
N200175 003 Jul 23, 2010
N200175 004 Jul 23, 2010
N200175 005 Jul 23, 2010
N022314 001 Apr 30, 2009
N022314 002 Apr 30, 2009
N022314 003 Apr 30, 2009
N022314 004 Apr 30, 2009
N022314 005 Apr 30, 2009
N022100 001 Sep 26, 2007
N022100 002 Sep 26, 2007
N022100 003 Sep 26, 2007
N022100 004 Sep 26, 2007
A201586 001 Jan 08, 2014
A201586 003 Jan 08, 2014
A201586 002 Jan 08, 2014
A201586 004 Jan 08, 2014
A202517 001 Jan 08, 2014
A202517 003 Jan 08, 2014
A202517 002 Jan 08, 2014
A202517 004 Jan 08, 2014
N022401 001 Oct 16, 2009
N022401 003 Oct 16, 2009
N022401 002 Oct 16, 2009
N022401 004 Oct 16, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
AMLODIPINE BESYLATE; VALSARTAN
TABLET;ORAL
AMLODIPINE BESYLATE AND VALSARTAN
AB PAR PHARM INC EQ 5MG BASE;160MG
AB EQ 5MG BASE;320MG
AB EQ 10MG BASE;160MG
AB EQ 10MG BASE;320MG
EXFORGE
AB NOVARTIS EQ 5MG BASE;160MG
AB EQ 5MG BASE;320MG
AB + EQ 10MG BASE;160MG
AB + EQ 10MG BASE;320MG
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN
TABLET;ORAL
AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE
AB TEVA PHARMS
AB
AB
AB
AB
AMMONIA N-13
INJECTABLE;INTRAVENOUS
AMMONIA N 13
AP CARDINAL HEALTH 414
AP + FEINSTEIN
AP KREITCHMAN PET CTR
AP MCPRF
AP UCLA BIOMEDICAL
HOUSTON CYCLOTRON
AMMONIUM CHLORIDE
INJECTABLE;INJECTION
5MG;12.5MG;160MG
5MG;25MG;160MG
10MG;12.5MG;160MG
10MG;25MG;160MG
10MG;25MG;320MG
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
3.75-260mCi/ML
AMMONIUM CHLORIDE IN PLASTIC CONTAINER
+ HOSPIRA
AMMONIUM LACTATE
CREAM;TOPICAL
AMMONIUM LACTATE
AB PERRIGO NEW YORK
AB TARO
AB WATSON LABS INC
LAC-HYDRIN
AB + RANBAXY
LOTION;TOPICAL
AMMONIUM LACTATE
AB PERRIGO NEW YORK
AB TARO
AB WATSON LABS INC
LAC-HYDRIN
AB + RANBAXY
AMOXAPINE
TABLET;ORAL
AMOXAPINE
WATSON LABS
+
AMOXICILLIN
CAPSULE;ORAL
AMOXICILLIN
AB AM ANTIBIOTICS
AB
AB AUROBINDO
AB
AB DAVA PHARMS INC
AB
AB HIKMA PHARMS
AB
AB RANBAXY
AB
AB SANDOZ
5MEQ/ML
EQ 12% BASE
EQ 12% BASE
EQ 12% BASE
EQ 12% BASE
EQ 12% BASE
EQ 12% BASE
EQ 12% BASE
EQ 12% BASE
25MG
50MG
100MG
150MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
3-25( of 362)
A090011 001 Mar 28, 2013
A090144 001 Mar 28, 2013
A090011 002 Mar 28, 2013
A090011 004 Mar 28, 2013
N021990 002 Jun 20, 2007
N021990 004 Jun 20, 2007
N021990 003 Jun 20, 2007
N021990 005 Jun 20, 2007
A200435 001 Sep 25, 2012
A200435 002 Sep 25, 2012
A200435 005 Sep 25, 2012
A200435 003 Sep 25, 2012
A200435 004 Sep 25, 2012
A203700 001 Feb 25, 2013
N022119 001 Aug 23, 2007
A203938 001 Dec 09, 2013
A203321 001 Feb 25, 2013
A203812 001 Jun 27, 2013
A203543 001 Dec 14, 2012
A088366 001 Jun 13, 1984
A075774 001 May 01, 2002
A075883 001 Apr 10, 2003
A076829 001 Feb 07, 2006
N020508 001 Aug 29, 1996
A075570 001 Jun 23, 2004
A076216 001 May 28, 2004
A075575 001 Jun 11, 2002
N019155 001 Apr 24, 1985
A072688 001 Aug 28, 1992
A072689 001 Aug 28, 1992
A072690 001 Aug 28, 1992
A072691 001 Aug 28, 1992
A062058 001
A062058 002
A065271 001 Nov 09, 2005
A065271 002 Nov 09, 2005
A062884 001 Feb 25, 1988
A062881 001 Feb 25, 1988
A065291 001 Feb 05, 2007
A065291 002 Feb 05, 2007
A065016 001 Apr 08, 1999
A065016 002 Apr 08, 1999
A064076 001 Sep 30, 1994
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-26( of 362)
AMOXICILLIN
CAPSULE;ORAL
AMOXICILLIN
AB 500MG A064076 002 Sep 30, 1994
AB TEVA 250MG A061926 001
AB + 500MG A061926 003
AMOXIL
AB DR REDDYS LABS INC 250MG A062216 001
AB 500MG A062216 004
FOR SUSPENSION;ORAL
AMOXICILLIN
AB AUROBINDO 200MG/5ML A065334 001 Dec 28, 2006
AB 400MG/5ML A065334 002 Dec 28, 2006
AB DAVA PHARMS INC 125MG/5ML A062927 001 Nov 25, 1988
AB 250MG/5ML A062927 002 Nov 25, 1988
AB HIKMA 125MG/5ML A065322 002 Jun 19, 2006
AB 200MG/5ML A065325 002 Jun 19, 2006
AB 250MG/5ML A065322 001 Jun 19, 2006
AB 400MG/5ML A065325 001 Jun 19, 2006
AB SANDOZ 125MG/5ML A065387 001 Mar 26, 2007
AB 200MG/5ML A065378 001 Mar 26, 2007
AB 250MG/5ML A065387 002 Mar 26, 2007
AB 400MG/5ML A065378 002 Mar 26, 2007
AB TEVA 125MG/5ML A061931 001
AB 200MG/5ML A065119 001 Dec 04, 2002
AB + 250MG/5ML A061931 002
AB + 400MG/5ML A065119 002 Dec 04, 2002
AB WOCKHARDT 400MG/5ML A065319 002 Jun 18, 2007
AMOXICILLIN PEDIATRIC
AB TEVA 50MG/ML A061931 003 Dec 01, 1982
AMOXIL
AB DR REDDYS LABS INC 50MG/ML A062226 005
AB 125MG/5ML A062226 001
AB 200MG/5ML N050760 001 Apr 15, 1999
AB 250MG/5ML A062226 002
AB 400MG/5ML N050760 002 Apr 15, 1999
LAROTID
AB DR REDDYS LABS INC 125MG/5ML A062226 003
AB 250MG/5ML A062226 004
TABLET;ORAL
AMOXICILLIN
AB AUROBINDO 500MG A065256 001 Nov 09, 2005
AB 875MG A065256 002 Nov 09, 2005
AB HIKMA 875MG A065255 001 Mar 29, 2006
AB RANBAXY 500MG A065059 001 Nov 24, 2000
AB 875MG A065059 002 Nov 24, 2000
AB SANDOZ 500MG A065228 001 Jul 13, 2005
AB 875MG A065228 002 Jul 13, 2005
AB TEVA 500MG A065056 001 Sep 18, 2000
AB + 875MG A065056 002 Sep 18, 2000
AMOXIL
AB DR REDDYS LABS INC 500MG N050754 002 Jul 10, 1998
AB 875MG N050754 001 Jul 10, 1998
TABLET, CHEWABLE;ORAL
AMOXICILLIN
AB RANBAXY 125MG A065021 001 Dec 23, 1999
AB 250MG A065021 002 Dec 23, 1999
AB TEVA 125MG A064013 002 Sep 11, 1995
AB + 250MG A064013 001 Dec 22, 1992
AMOXIL
AB DR REDDYS LABS INC 125MG N050542 002
AB 250MG N050542 001
TABLET, EXTENDED RELEASE;ORAL
MOXATAG
+ SHIONOGI INC 775MG N050813 001 Jan 23, 2008
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN
AB TEVA PHARMS USA 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M A200218 001 Aug 30, 2013
G
PREVPAC
AB + TAKEDA PHARMS USA 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A, N050757 001 Dec 02, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-27( of 362)
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
PREVPAC
30MG
AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
CAPSULE, TABLET, CAPSULE, DELAYED RELEASE, TABLET;ORAL
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN
+ GASTROENTERO 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20M N050824 001 Feb 08, 2011
G
AMOXICILLIN; CLAVULANATE POTASSIUM
FOR SUSPENSION;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB HIKMA PHARMS 200MG/5ML;EQ 28.5MG BASE/5ML A065191 002 Jan 25, 2005
AB 400MG/5ML;EQ 57MG BASE/5ML A065191 001 Jan 25, 2005
AB 600MG/5ML;EQ 42.9MG BASE/5ML A065373 001 Nov 09, 2007
AB RANBAXY 200MG/5ML;EQ 28.5MG BASE/5ML A065132 001 Mar 19, 2003
AB 400MG/5ML;EQ 57MG BASE/5ML A065132 002 Mar 19, 2003
AB 600MG/5ML;EQ 42.9MG BASE/5ML A065207 002 Jan 30, 2007
AB SANDOZ 200MG/5ML;EQ 28.5MG BASE/5ML A065066 001 Jun 05, 2002
AB 400MG/5ML;EQ 57MG BASE/5ML A065066 002 Jun 05, 2002
AB SANDOZ INC 200MG/5ML;EQ 28.5MG BASE/5ML A065098 001 Dec 16, 2002
AB 400MG/5ML;EQ 57MG BASE/5ML A065098 002 Dec 16, 2002
AB 600MG/5ML;EQ 42.9MG BASE/5ML A065358 001 Aug 13, 2007
AB TEVA 200MG/5ML;EQ 28.5MG BASE/5ML A065089 001 May 25, 2004
AB + 400MG/5ML;EQ 57MG BASE/5ML A065089 002 May 25, 2004
AB + 600MG/5ML;EQ 42.9MG BASE/5ML A065162 001 Mar 12, 2004
AB WOCKHARDT 250MG/5ML;EQ 62.5MG BASE/5ML A065431 001 Nov 25, 2008
AB WOCKHARDT EU OPERATN 600MG/5ML;EQ 42.9MG BASE/5ML A065420 001 Dec 02, 2013
AUGMENTIN '125'
AB DR REDDYS LABS INC 125MG/5ML;EQ 31.25MG BASE/5ML N050575 001 Aug 06, 1984
AUGMENTIN '200'
AB DR REDDYS LABS INC 200MG/5ML;EQ 28.5MG BASE/5ML N050725 001 May 31, 1996
AUGMENTIN '250'
AB + DR REDDYS LABS INC 250MG/5ML;EQ 62.5MG BASE/5ML N050575 002 Aug 06, 1984
AUGMENTIN '400'
AB DR REDDYS LABS INC 400MG/5ML;EQ 57MG BASE/5ML N050725 002 May 31, 1996
AUGMENTIN ES-600
AB DR REDDYS LABS INC 600MG/5ML;EQ 42.9MG BASE/5ML N050755 001 Jun 22, 2001
SUSPENSION;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB AUROBINDO PHARMA LTD 200MG/5ML;EQ 28.5MG BASE/5ML A201090 001 Dec 20, 2011
AB 400MG/5ML;EQ 57MG BASE/5ML A201090 002 Dec 20, 2011
AB 600MG/5ML;EQ 42.9MG BASE/5ML A201091 001 Dec 20, 2011
TABLET;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB AUROBINDO PHARMA LTD 250MG;EQ 125MG BASE A091569 001 Jan 20, 2012
AB 500MG;EQ 125MG BASE A091569 002 Jan 20, 2012
AB 875MG;EQ 125MG BASE A091568 001 Jan 20, 2012
AB RANBAXY 875MG;EQ 125MG BASE A065102 001 Sep 17, 2002
AB SANDOZ 250MG;EQ 125MG BASE A065189 001 Aug 23, 2005
AB 500MG;EQ 125MG BASE A065064 001 Mar 15, 2002
AB 875MG;EQ 125MG BASE A065063 001 Mar 14, 2002
AB SANDOZ INC 500MG;EQ 125MG BASE A065117 001 Nov 27, 2002
AB 875MG;EQ 125MG BASE A065093 001 Nov 21, 2002
AB TEVA 500MG;EQ 125MG BASE A065101 001 Oct 30, 2002
AB TEVA PHARMS USA 875MG;EQ 125MG BASE A065096 001 Oct 29, 2002
AUGMENTIN '250'
AB + DR REDDYS LABS INC 250MG;EQ 125MG BASE N050564 001 Aug 06, 1984
AUGMENTIN '500'
AB + DR REDDYS LABS INC 500MG;EQ 125MG BASE N050564 002 Aug 06, 1984
AUGMENTIN '875'
AB + DR REDDYS LABS INC 875MG;EQ 125MG BASE N050720 001 Feb 13, 1996
TABLET, CHEWABLE;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB RANBAXY 200MG;EQ 28.5MG BASE A065161 001 Dec 03, 2003
AB 400MG;EQ 57MG BASE A065161 002 Dec 03, 2003
AB SANDOZ 200MG;EQ 28.5MG BASE A065065 001 Apr 18, 2002
AB 400MG;EQ 57MG BASE A065065 002 Apr 18, 2002
AB TEVA 200MG;EQ 28.5MG BASE A065205 001 Feb 09, 2005
AB + 400MG;EQ 57MG BASE A065205 002 Feb 09, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-28( of 362)
AMOXICILLIN; CLAVULANATE POTASSIUM
TABLET, CHEWABLE;ORAL
AUGMENTIN '125'
AB DR REDDYS LABS INC 125MG;EQ 31.25MG BASE N050597 001 Jul 22, 1985
AUGMENTIN '200'
AB DR REDDYS LABS INC 200MG;EQ 28.5MG BASE N050726 001 May 31, 1996
AUGMENTIN '250'
AB DR REDDYS LABS INC 250MG;EQ 62.5MG BASE N050597 002 Jul 22, 1985
AUGMENTIN '400'
AB DR REDDYS LABS INC 400MG;EQ 57MG BASE N050726 002 May 31, 1996
TABLET, EXTENDED RELEASE;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB SANDOZ 1GM;EQ 62.5MG BASE A090227 001 Apr 21, 2010
AUGMENTIN XR
AB + DR REDDYS LABS INC 1GM;EQ 62.5MG BASE N050785 001 Sep 25, 2002
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
SULFATE
CAPSULE, EXTENDED RELEASE;ORAL
ADDERALL XR 10
AB SHIRE 2.5MG;2.5MG;2.5MG;2.5MG N021303 001 Oct 11, 2001
ADDERALL XR 15
AB SHIRE 1.25MG;1.25MG;1.25MG;1.25MG N021303 005 May 22, 2002
AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF
AB TEVA 1.25MG;1.25MG;1.25MG;1.25MG A077488 001 Apr 29, 2013
AB 2.5MG;2.5MG;2.5MG;2.5MG A077488 002 Apr 29, 2013
AB 3.75MG;3.75MG;3.75MG;3.75MG A077488 003 Apr 29, 2013
AB 5MG;5MG;5MG;5MG A077488 004 Apr 29, 2013
AB 6.25MG;6.25MG;6.25MG;6.25MG A077488 005 Apr 29, 2013
AB 7.5MG;7.5MG;7.5MG;7.5MG A077488 006 Apr 29, 2013
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
AB ACTAVIS ELIZABETH 1.25MG;1.25MG;1.25MG;1.25MG A077302 001 Jun 22, 2012
AB 2.5MG;2.5MG;2.5MG;2.5MG A077302 002 Jun 22, 2012
AB 3.75MG;3.75MG;3.75MG;3.75MG A077302 003 Jun 22, 2012
AB 5MG;5MG;5MG;5MG A077302 004 Jun 22, 2012
AB 6.25MG;6.25MG;6.25MG;6.25MG A077302 005 Jun 22, 2012
AB 7.5MG;7.5MG;7.5MG;7.5MG A077302 006 Jun 22, 2012
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE
AB BARR LABS INC 1.25MG;1.25MG;1.25MG;1.25MG A076536 001 Feb 12, 2013
AB 2.5MG;2.5MG;2.5MG;2.5MG A076536 002 Feb 12, 2013
AB 3.75MG;3.75MG;3.75MG;3.75MG A076536 003 Feb 12, 2013
AB 5MG;5MG;5MG;5MG A076536 004 Feb 12, 2013
AB 6.25MG;6.25MG;6.25MG;6.25MG A076536 005 Feb 12, 2013
AB 7.5MG;7.5MG;7.5MG;7.5MG A076536 006 Feb 12, 2013
TABLET;ORAL
AB SHIRE 3.75MG;3.75MG;3.75MG;3.75MG N021303 006 May 22, 2002
ADDERALL XR 20
AB SHIRE 5MG;5MG;5MG;5MG N021303 002 Oct 11, 2001
ADDERALL XR 25
AB SHIRE 6.25MG;6.25MG;6.25MG;6.25MG N021303 004 May 22, 2002
ADDERALL XR 30
AB + SHIRE 7.5MG;7.5MG;7.5MG;7.5MG N021303 003 Oct 11, 2001
ADDERALL XR 5
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
AB AUROLIFE PHARMA LLC 1.25MG;1.25MG;1.25MG;1.25MG A202424 001 Nov 27, 2013
AB 1.875MG;1.875MG;1.875MG;1.875MG A202424 002 Nov 27, 2013
AB 2.5MG;2.5MG;2.5MG;2.5MG A202424 003 Nov 27, 2013
AB 3.125MG;3.125MG;3.125MG;3.125MG A202424 004 Nov 27, 2013
AB 3.75MG;3.75MG;3.75MG;3.75MG A202424 005 Nov 27, 2013
AB 5MG;5MG;5MG;5MG A202424 006 Nov 27, 2013
AB 7.5MG;7.5MG;7.5MG;7.5MG A202424 007 Nov 27, 2013
AB BARR 1.25MG;1.25MG;1.25MG;1.25MG A040422 001 Feb 11, 2002
AB 1.875MG;1.875MG;1.875MG;1.875MG A040422 005 Mar 19, 2003
AB 2.5MG;2.5MG;2.5MG;2.5MG A040422 002 Feb 11, 2002
AB 3.125MG;3.125MG;3.125MG;3.125MG A040422 006 Mar 19, 2003
AB 3.75MG;3.75MG;3.75MG;3.75MG A040422 007 Mar 19, 2003
AB 5MG;5MG;5MG;5MG A040422 003 Feb 11, 2002
AB + 7.5MG;7.5MG;7.5MG;7.5MG A040422 004 Feb 11, 2002
AB COREPHARMA 1.25MG;1.25MG;1.25MG;1.25MG A040444 001 Jun 19, 2002
AB 2.5MG;2.5MG;2.5MG;2.5MG A040444 002 Jun 19, 2002
AB 5MG;5MG;5MG;5MG A040444 003 Jun 19, 2002
AB 7.5MG;7.5MG;7.5MG;7.5MG A040444 004 Jun 19, 2002
AB MALLINCKRODT INC 1.25MG;1.25MG;1.25MG;1.25MG A040440 001 Oct 07, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-29( of 362)
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
SULFATE
TABLET;ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
AB 1.875MG;1.875MG;1.875MG;1.875MG A040440 002 Oct 07, 2003
AB 2.5MG;2.5MG;2.5MG;2.5MG A040440 003 Oct 07, 2003
AB 3.125MG;3.125MG;3.125MG;3.125MG A040440 004 Oct 07, 2003
AB 3.75MG;3.75MG;3.75MG;3.75MG A040440 005 Oct 07, 2003
AB 5MG;5MG;5MG;5MG A040440 006 Oct 07, 2003
AB 7.5MG;7.5MG;7.5MG;7.5MG A040440 007 Oct 07, 2003
AB MUTUAL PHARM 1.25MG;1.25MG;1.25MG;1.25MG A040480 001 Sep 09, 2003
AB 1.875MG;1.875MG;1.875MG;1.875MG A040480 002 Sep 09, 2003
AB 2.5MG;2.5MG;2.5MG;2.5MG A040480 003 Sep 09, 2003
AB 3.125MG;3.125MG;3.125MG;3.125MG A040480 004 Sep 09, 2003
AB 3.75MG;3.75MG;3.75MG;3.75MG A040480 005 Sep 09, 2003
AB 5MG;5MG;5MG;5MG A040480 006 Sep 09, 2003
AB 7.5MG;7.5MG;7.5MG;7.5MG A040480 007 Sep 09, 2003
AB SANDOZ 1.25MG;1.25MG;1.25MG;1.25MG A040439 004 Sep 27, 2002
AB 2.5MG;2.5MG;2.5MG;2.5MG A040439 001 Jun 14, 2002
AB 5MG;5MG;5MG;5MG A040439 002 Jun 14, 2002
AB 7.5MG;7.5MG;7.5MG;7.5MG A040439 003 Jun 14, 2002
AMPHETAMINE SULFATE
TABLET;ORAL
AMPHETAMINE SULFATE
ARBOR PHARMS INC 5MG A200166 001 Aug 09, 2012
+ 10MG A200166 002 Aug 09, 2012
AMPHOTERICIN B
INJECTABLE;INJECTION
AMPHOTERICIN B
+ X GEN PHARMS 50MG/VIAL A063206 001 Apr 29, 1992
INJECTABLE, LIPID COMPLEX;INJECTION
ABELCET
+ SIGMA TAU 5MG/ML N050724 001 Nov 20, 1995
AMPHOTEC
+ ALKOPHARMA USA 50MG/VIAL N050729 001 Nov 22, 1996
+ 100MG/VIAL N050729 002 Nov 22, 1996
INJECTABLE, LIPOSOMAL;INJECTION
AMBISOME
+ ASTELLAS 50MG/VIAL N050740 001 Aug 11, 1997
AMPICILLIN SODIUM
INJECTABLE;INJECTION
AMPICILLIN SODIUM
AP ACS DOBFAR SPA EQ 1GM BASE/VIAL A090884 002 Apr 03, 2013
AP EQ 2GM BASE/VIAL A090884 003 Apr 03, 2013
AP EQ 10GM BASE/VIAL A090889 001 Apr 03, 2013
AP EQ 500MG BASE/VIAL A090884 001 Apr 03, 2013
AP AUROBINDO PHARMA EQ 1GM BASE/VIAL A065499 004 Aug 17, 2010
AP EQ 2GM BASE/VIAL A065499 005 Aug 17, 2010
AP EQ 10GM BASE/VIAL A065493 001 Aug 17, 2010
AP EQ 125MG BASE/VIAL A065499 001 Aug 17, 2010
AP EQ 250MG BASE/VIAL A065499 002 Aug 17, 2010
AP EQ 500MG BASE/VIAL A065499 003 Aug 17, 2010
AP HANFORD GC EQ 1GM BASE/VIAL A062772 001 Apr 15, 1993
AP EQ 2GM BASE/VIAL A063140 001 Apr 15, 1993
AP EQ 10GM BASE/VIAL A063142 001 Apr 15, 1993
AP EQ 250MG BASE/VIAL A063145 001 Apr 15, 1993
AP EQ 500MG BASE/VIAL A063146 001 Apr 15, 1993
AP IBI EQ 1GM BASE/VIAL A062719 002 May 12, 1987
AP EQ 2GM BASE/VIAL A062797 002 Jul 12, 1993
AP EQ 125MG BASE/VIAL A062797 001 Jul 12, 1993
AP EQ 250MG BASE/VIAL A062719 001 May 12, 1987
AP EQ 500MG BASE/VIAL A062719 003 May 12, 1987
AP ISTITUTO BIO ITA SPA EQ 10MG BASE/VIAL A201404 001 Dec 20, 2013
AP + SANDOZ EQ 1GM BASE/VIAL A061395 004
AP EQ 1GM BASE/VIAL A062738 001 Feb 19, 1987
AP + EQ 2GM BASE/VIAL A061395 005
AP EQ 2GM BASE/VIAL A062738 002 Feb 19, 1987
AP + EQ 10GM BASE/VIAL A061395 006
AP + EQ 125MG BASE/VIAL A061395 001
AP + EQ 250MG BASE/VIAL A061395 002
AP + EQ 500MG BASE/VIAL A061395 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-30( of 362)
AMPICILLIN SODIUM; SULBACTAM SODIUM
INJECTABLE;INJECTION
AMPICILLIN AND SULBACTAM
AP ACS DOBFAR EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065406 001 Dec 22, 2009
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065406 002 Dec 22, 2009
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065403 001 Dec 23, 2009
AP AUROBINDO PHARMA EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A090340 001 Sep 20, 2010
AP EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A090349 001 Sep 20, 2010
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A090340 002 Sep 20, 2010
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A090349 002 Sep 20, 2010
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A090339 001 Sep 20, 2010
AP HANFORD GC EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065176 001 Nov 30, 2005
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065176 002 Nov 30, 2005
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065188 001 Nov 25, 2005
AP HIKMA MAPLE EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065074 001 Mar 19, 2002
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065074 002 Mar 19, 2002
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065076 001 Mar 19, 2002
AP HOSPIRA INC EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A090375 001 Dec 21, 2011
AP EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A090653 001 Dec 21, 2011
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A090375 002 Dec 21, 2011
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A090653 002 Dec 21, 2011
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A090646 001 Dec 21, 2011
AP IBI EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065222 001 Nov 29, 2005
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065222 002 Nov 29, 2005
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065314 001 Nov 27, 2006
AP MYLAN INSTITUTIONAL EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065316 001 Jun 29, 2007
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065316 002 Jun 29, 2007
AP SANDOZ EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065241 001 Jul 25, 2006
AP EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065310 001 Jul 25, 2006
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065241 002 Jul 25, 2006
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065310 002 Jul 25, 2006
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065240 001 Jul 25, 2006
UNASYN
AP + PFIZER EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A062901 002 Feb 27, 1992
AP + EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A062901 001 Nov 23, 1988
AP + EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL N050608 002 Dec 31, 1986
AP + EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL N050608 001 Dec 31, 1986
AP + EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL N050608 005 Dec 10, 1993
AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE;ORAL
AMPICILLIN TRIHYDRATE
AB DAVA PHARMS INC EQ 250MG BASE A062883 001 Feb 25, 1988
AB + EQ 500MG BASE A062882 001 Feb 25, 1988
AB SANDOZ EQ 250MG BASE A064082 001 Aug 29, 1995
AB EQ 500MG BASE A064082 002 Aug 29, 1995
FOR SUSPENSION;ORAL
AMPICILLIN TRIHYDRATE
DAVA PHARMS INC EQ 125MG BASE/5ML A062982 001 Feb 10, 1989
+ EQ 250MG BASE/5ML A062982 002 Feb 10, 1989
ANAGRELIDE HYDROCHLORIDE
CAPSULE;ORAL
AGRYLIN
AB SHIRE LLC EQ 0.5MG BASE N020333 001 Mar 14, 1997
ANAGRELIDE HYDROCHLORIDE
AB BARR EQ 0.5MG BASE A076530 001 Apr 18, 2005
AB EQ 1MG BASE A076530 002 Apr 18, 2005
AB IMPAX LABS EQ 0.5MG BASE A076910 001 Apr 18, 2005
AB EQ 1MG BASE A076910 002 Apr 18, 2005
AB IVAX SUB TEVA PHARMS EQ 0.5MG BASE A076468 001 Apr 18, 2005
AB + EQ 1MG BASE A076468 002 Apr 18, 2005
AB MYLAN EQ 0.5MG BASE A076811 001 Apr 18, 2005
AB EQ 1MG BASE A076811 002 Apr 18, 2005
AB MYLAN PHARMS INC EQ 0.5MG BASE A077613 001 Jun 27, 2006
AB EQ 1MG BASE A077613 002 Jun 27, 2006
ANASTROZOLE
TABLET;ORAL
ANASTROZOLE
AB ACCORD HLTHCARE 1MG A090568 001 Jun 28, 2010
AB APOTEX INC 1MG A200654 001 May 11, 2012
AB DR REDDYS LABS LTD 1MG A090732 001 Jun 28, 2010
AB FRESENIUS KABI ONCOL 1MG A090088 001 Jun 28, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-31( of 362)
ANASTROZOLE
TABLET;ORAL
ANASTROZOLE
AB MYLAN 1MG A091051 001 Jun 28, 2010
AB NATCO PHARMA LTD 1MG A079220 001 Jun 28, 2010
AB ROXANE 1MG A078485 001 Jun 28, 2010
AB SANDOZ 1MG A079007 001 Jun 28, 2010
AB SANTOS BIOTECH 1MG A078944 001 Jun 28, 2010
AB SUN PHARM INDS LTD 1MG A091177 001 Jul 15, 2011
AB TEVA PHARMS 1MG A078058 001 Jun 28, 2010
AB THREE RIVERS PHARMS 1MG A091164 001 Jun 28, 2010
AB WATSON LABS 1MG A078984 001 Jun 28, 2010
AB ZYDUS PHARMS USA INC 1MG A078921 001 Jun 28, 2010
ARIMIDEX
AB + ASTRAZENECA 1MG N020541 001 Dec 27, 1995
ANIDULAFUNGIN
INJECTABLE;IV (INFUSION)
ERAXIS
+ VICURON 50MG/VIAL N021632 001 Feb 17, 2006
+ 100MG/VIAL N021632 002 Nov 14, 2006
APIXABAN
TABLET;ORAL
ELIQUIS
BRISTOL MYERS SQUIBB 2.5MG N202155 001 Dec 28, 2012
+ 5MG N202155 002 Dec 28, 2012
APOMORPHINE HYDROCHLORIDE
INJECTABLE;SUBCUTANEOUS
APOKYN
+ US WORLDMEDS 30MG/3ML (10MG/ML) N021264 002 Apr 20, 2004
APRACLONIDINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
APRACLONIDINE HYDROCHLORIDE
AT AKORN INC EQ 0.5% BASE A077764 001 Mar 12, 2009
IOPIDINE
AT + ALCON EQ 0.5% BASE N020258 001 Jul 30, 1993
+ EQ 1% BASE N019779 001 Dec 31, 1987
APREPITANT
CAPSULE;ORAL
APREPITANT
AB SANDOZ 40MG A090999 001 Sep 24, 2012
AB 80MG A090999 002 Sep 24, 2012
AB 125MG A090999 003 Sep 24, 2012
EMEND
AB MERCK 40MG N021549 003 Jun 30, 2006
AB 80MG N021549 001 Mar 26, 2003
AB + 125MG N021549 002 Mar 26, 2003
ARFORMOTEROL TARTRATE
SOLUTION;INHALATION
BROVANA
+ SUNOVION EQ 0.015MG BASE/2ML N021912 001 Oct 06, 2006
ARGATROBAN
INJECTABLE;INJECTION
ACOVA
AP + PFIZER 250MG/2.5ML (100MG/ML) N020883 001 Jun 30, 2000
ARGATROBAN
AP HIKMA PHARM CO LTD 250MG/2.5ML (100MG/ML) N203049 001 Jan 05, 2012
INJECTABLE;IV (INFUSION)
ARGATROBAN IN SODIUM CHLORIDE
+ EAGLE PHARMS 50MG/50ML (1MG/ML) N022434 001 Jun 29, 2011
+ SANDOZ 125MG/125ML (1MG/ML) N022485 001 May 09, 2011
ARGININE HYDROCHLORIDE
INJECTABLE;INJECTION
R-GENE 10
+ PHARMACIA AND UPJOHN 10GM/100ML N016931 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-32( of 362)
ARIPIPRAZOLE
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
ABILIFY MAINTENA KIT
OTSUKA PHARM CO LTD 300MG/VIAL N202971 001 Feb 28, 2013
+ 400MG/VIAL N202971 002 Feb 28, 2013
INJECTABLE;INTRAMUSCULAR
ABILIFY
+ OTSUKA 9.75MG/1.3ML (7.5MG/ML) N021866 001 Sep 20, 2006
SOLUTION;ORAL
ABILIFY
+ OTSUKA 1MG/ML N021713 001 Dec 10, 2004
TABLET;ORAL
ABILIFY
OTSUKA 2MG N021436 006 Nov 15, 2002
+ 5MG N021436 005 Nov 15, 2002
+ 10MG N021436 001 Nov 15, 2002
15MG N021436 002 Nov 15, 2002
20MG N021436 003 Nov 15, 2002
30MG N021436 004 Nov 15, 2002
TABLET, ORALLY DISINTEGRATING;ORAL
ABILIFY
+ OTSUKA 10MG N021729 002 Jun 07, 2006
15MG N021729 003 Jun 07, 2006
ARMODAFINIL
TABLET;ORAL
ARMODAFINIL
AB MYLAN PHARMS INC 50MG A200043 001 Jun 01, 2012
AB 150MG A200043 002 Jun 01, 2012
AB 250MG A200043 003 Jun 01, 2012
NUVIGIL
AB CEPHALON 50MG N021875 001 Jun 15, 2007
AB 150MG N021875 003 Jun 15, 2007
AB + 250MG N021875 004 Jun 15, 2007
ARMODAFINIL
WATSON LABS INC 100MG A200156 002 Aug 29, 2012
200MG A200156 004 Aug 29, 2012
ARSENIC TRIOXIDE
INJECTABLE;INJECTION
TRISENOX
+ CEPHALON 1MG/ML N021248 001 Sep 25, 2000
ARTEMETHER; LUMEFANTRINE
TABLET;ORAL
COARTEM
+ NOVARTIS 20MG;120MG N022268 001 Apr 07, 2009
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
INJECTABLE;INJECTION
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
AP HOSPIRA 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG A079138 001 Jun 18, 2010
BASE/ML)
SEPTOCAINE
AP + DEPROCO 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG N020971 001 Apr 03, 2000
BASE/ML)
ORABLOC
PIERREL 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG N022466 001 Feb 26, 2010
BASE/ML)
+ 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG N022466 002 Feb 26, 2010
BASE/ML)
SEPTOCAINE
+ DEPROCO 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ N022010 001 Mar 30, 2006
0.005MG BASE/ML)
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K
INJECTABLE;IV (INFUSION)
INFUVITE PEDIATRIC
+ SANDOZ 80MG/VIAL;0.02MG/VIAL;400 N021265 001 Feb 21, 2001
IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI
AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/
VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
+ SANDOZ 80MG/VIAL;0.02MG/VIAL;400 N021646 001 Jan 29, 2004
IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI
AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-33( of 362)
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K
INJECTABLE;IV (INFUSION)
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE;
VITAMIN A; VITAMIN E
FOR SOLUTION;IV (INFUSION)
M.V.I. PEDIATRIC
+ HOSPIRA 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/ N018920 001 Sep 21, 2000
VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;
0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG
BASE/VIAL;0.7MG/VIAL;7MG/VIAL
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;
VITAMIN E
INJECTABLE;INJECTION
M.V.I.-12 (WITHOUT VITAMIN K)
+ HOSPIRA 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML; N008809 006 Sep 09, 2004
0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0
.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;
VITAMIN E; VITAMIN K
INJECTABLE;IV (INFUSION)
M.V.I. ADULT
+ HOSPIRA 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M N021625 001 Jan 30, 2004
G/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIA
L;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL
;10MG/VIAL;0.15MG/VIAL
M.V.I. ADULT (PHARMACY BULK PACKAGE)
+ HOSPIRA 200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5 N021643 001 Feb 18, 2004
ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5
ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0
.15MG/5ML
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE;
SODIUM SULFATE
FOR SOLUTION;ORAL
MOVIPREP
+ SALIX PHARMS 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM N021881 001 Aug 02, 2006
ASENAPINE MALEATE
TABLET;SUBLINGUAL
SAPHRIS
ORGANON SUB MERCK EQ 5MG BASE N022117 001 Aug 13, 2009
+ EQ 10MG BASE N022117 002 Aug 13, 2009
ASPIRIN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
FIORINAL
AA + WATSON LABS INC 325MG;50MG;40MG N017534 005 Apr 16, 1986
LANORINAL
AA LANNETT 325MG;50MG;40MG A086996 002 Oct 11, 1985
TABLET;ORAL
BUTALBITAL, ASPIRIN AND CAFFEINE
AA + WEST WARD 325MG;50MG;40MG A086162 002 Feb 16, 1984
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE;ORAL
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
AB NEXGEN PHARMA INC 325MG;50MG;40MG;30MG A075231 001 Nov 30, 2001
AB STEVENS J 325MG;50MG;40MG;30MG A074951 001 Aug 31, 1998
AB WATSON LABS 325MG;50MG;40MG;30MG A074359 001 Aug 31, 1995
FIORINAL W/CODEINE
AB + WATSON LABS INC 325MG;50MG;40MG;30MG N019429 003 Oct 26, 1990
ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE
CAPSULE;ORAL
SYNALGOS-DC
+ CARACO 356.4MG;30MG;16MG N011483 004 Sep 06, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
TABLET;ORAL
NORGESIC
AB MEDICIS
NORGESIC FORTE
385MG;30MG;25MG
AB + MEDICIS 770MG;60MG;50MG
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
AB SANDOZ
AB
AB STEVENS J
AB
ASPIRIN; CARISOPRODOL
TABLET;ORAL
CARISOPRODOL AND ASPIRIN
AB HERITAGE PHARMS INC
AB MIRROR PHARMS
AB PROSAM LABS
AB SANDOZ
SOMA COMPOUND
AB + MEDA PHARMS
ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE
TABLET;ORAL
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
AB MIRROR PHARMS 325MG;200MG;16MG
AB PROSAM LABS 325MG;200MG;16MG
AB SANDOZ 325MG;200MG;16MG
SOMA COMPOUND W/ CODEINE
AB + MEDA PHARMS 325MG;200MG;16MG
ASPIRIN; DIPYRIDAMOLE
CAPSULE, EXTENDED RELEASE;ORAL
AGGRENOX
AB + BOEHRINGER INGELHEIM
ASPIRIN AND DIPYRIDAMOLE
AB BARR
ASPIRIN; METHOCARBAMOL
TABLET;ORAL
METHOCARBAMOL AND ASPIRIN
+ STEVENS J
385MG;30MG;25MG
770MG;60MG;50MG
385MG;30MG;25MG
770MG;60MG;50MG
325MG;200MG
325MG;200MG
325MG;200MG
325MG;200MG
325MG;200MG
25MG;200MG
25MG;200MG
325MG;400MG
ASPIRIN; OXYCODONE HYDROCHLORIDE
TABLET;ORAL
OXYCODONE AND ASPIRIN
AA
AA
COASTAL PHARMS
WATSON LABS
PERCODAN
325MG;4.8355MG
325MG;4.8355MG
AA + ENDO PHARMS 325MG;4.8355MG
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
TABLET;ORAL
OXYCODONE AND ASPIRIN
WATSON LABS
ATAZANAVIR SULFATE
CAPSULE;ORAL
REYATAZ
BRISTOL MYERS SQUIBB
+
ATENOLOL
TABLET;ORAL
ATENOLOL
AB AUROBINDO PHARMA
AB
AB
AB CARACO
AB
AB
AB DAVA PHARMS INC
AB
AB
325MG;4.5MG;0.38MG
EQ 100MG BASE
EQ 150MG BASE
EQ 200MG BASE
EQ 300MG BASE
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
3-34( of 362)
N013416 003 Oct 27, 1982
N013416 004 Oct 27, 1982
A074654 001 Dec 31, 1996
A074654 002 Dec 31, 1996
A074988 001 Apr 30, 1999
A074988 002 Apr 30, 1999
A089594 001 Mar 31, 1989
A040832 001 Jan 07, 2010
A040252 001 Dec 10, 1997
A040116 001 Apr 25, 1996
N012365 005 Jul 11, 1983
A040860 001 Jan 07, 2010
A040283 001 Dec 29, 1998
A040118 001 Apr 16, 1996
N012366 002 Jul 11, 1983
N020884 001 Nov 22, 1999
A078804 001 Aug 14, 2009
A081145 001 Jan 31, 1995
A091670 001 Mar 16, 2011
A090084 001 Mar 22, 2011
N007337 007 Aug 05, 2005
A040255 001 Feb 27, 1998
N021567 001 Jun 20, 2003
N021567 002 Jun 20, 2003
N021567 003 Jun 20, 2003
N021567 004 Oct 16, 2006
A078512 001 Oct 31, 2007
A078512 002 Oct 31, 2007
A078512 003 Oct 31, 2007
A078210 001 Jul 10, 2007
A078210 002 Jul 10, 2007
A078210 003 Jul 10, 2007
A074099 001 Apr 28, 1992
A073542 001 Dec 19, 1991
A073543 001 Dec 19, 1991
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-35( of 362)
ATENOLOL
TABLET;ORAL
ATENOLOL
AB IPCA LABS LTD 25MG A077877 001 Dec 27, 2006
AB 50MG A077877 002 Dec 27, 2006
AB 100MG A077877 003 Dec 27, 2006
AB IPR 25MG A073646 001 Jul 31, 1992
AB 50MG A072303 001 Jul 15, 1988
AB 100MG A072304 001 Jul 15, 1988
AB MUTUAL PHARM 25MG A074499 001 Jul 30, 1997
AB 50MG A073475 001 Mar 30, 1993
AB 100MG A073476 001 Mar 30, 1993
AB MYLAN 25MG A073457 002 Apr 26, 1999
AB 50MG A073456 001 Jan 24, 1992
AB 100MG A073457 001 Jan 24, 1992
AB NORTHSTAR HLTHCARE 25MG A078254 001 Sep 25, 2009
AB 50MG A078254 002 Sep 25, 2009
AB 100MG A078254 003 Sep 25, 2009
AB SANDOZ 25MG A074052 001 May 01, 1992
AB 50MG A073025 001 Sep 17, 1991
AB 100MG A073026 001 Sep 17, 1991
AB TEVA 25MG A074056 003 Jul 19, 2004
AB 50MG A074056 001 Jan 18, 1995
AB 100MG A074056 002 Jan 18, 1995
AB UNIQUE PHARM LABS 25MG A077443 001 Sep 13, 2006
AB 50MG A077443 002 Sep 13, 2006
AB 100MG A077443 003 Sep 13, 2006
AB ZYDUS PHARMS USA 25MG A076900 001 Jan 28, 2005
AB 50MG A076900 002 Jan 28, 2005
AB 100MG A076900 003 Jan 28, 2005
TENORMIN
AB ASTRAZENECA 25MG N018240 004 Apr 09, 1990
AB 50MG N018240 001
AB + 100MG N018240 002
ATENOLOL; CHLORTHALIDONE
TABLET;ORAL
ATENOLOL AND CHLORTHALIDONE
AB IPR 50MG;25MG A072301 001 May 31, 1990
AB 100MG;25MG A072302 001 May 31, 1990
AB MUTUAL PHARM 50MG;25MG A073581 001 Apr 29, 1993
AB 100MG;25MG A073582 001 Apr 29, 1993
AB MYLAN 50MG;25MG A074203 001 Oct 31, 1993
AB 100MG;25MG A074203 002 Oct 31, 1993
AB WATSON LABS 50MG;25MG A073665 001 Jul 02, 1992
AB 100MG;25MG A073665 002 Jul 02, 1992
TENORETIC 100
AB + ASTRAZENECA 100MG;25MG N018760 001 Jun 08, 1984
TENORETIC 50
AB ASTRAZENECA 50MG;25MG N018760 002 Jun 08, 1984
ATOMOXETINE HYDROCHLORIDE
CAPSULE;ORAL
STRATTERA
LILLY 10MG N021411 002 Nov 26, 2002
18MG N021411 003 Nov 26, 2002
25MG N021411 004 Nov 26, 2002
40MG N021411 005 Nov 26, 2002
+ 60MG N021411 006 Nov 26, 2002
80MG N021411 007 Feb 14, 2005
100MG N021411 008 Feb 14, 2005
ATORVASTATIN CALCIUM
TABLET;ORAL
ATORVASTATIN CALCIUM
AB APOTEX INC EQ 10MG BASE A090548 001 May 29, 2012
AB EQ 20MG BASE A090548 002 May 29, 2012
AB EQ 40MG BASE A090548 003 May 29, 2012
AB EQ 80MG BASE A090548 004 May 29, 2012
AB DR REDDYS LABS LTD EQ 10MG BASE A091650 001 Jul 17, 2012
AB EQ 20MG BASE A091650 002 Jul 17, 2012
AB EQ 40MG BASE A091650 003 Jul 17, 2012
AB EQ 80MG BASE A202357 001 Jul 17, 2012
AB KUDCO IRELAND EQ 10MG BASE A091624 001 Apr 05, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-36( of 362)
ATORVASTATIN CALCIUM
TABLET;ORAL
ATORVASTATIN CALCIUM
AB EQ 20MG BASE A091624 002 Apr 05, 2013
AB EQ 40MG BASE A091624 003 Apr 05, 2013
AB EQ 80MG BASE A091624 004 Apr 05, 2013
AB MYLAN PHARMS INC EQ 10MG BASE A091226 001 May 29, 2012
AB EQ 20MG BASE A091226 002 May 29, 2012
AB EQ 40MG BASE A091226 003 May 29, 2012
AB EQ 80MG BASE A091226 004 May 29, 2012
AB RANBAXY LABS LTD EQ 10MG BASE A076477 001 Nov 30, 2011
AB EQ 20MG BASE A076477 002 Nov 30, 2011
AB EQ 40MG BASE A076477 003 Nov 30, 2011
AB EQ 80MG BASE A076477 004 Nov 30, 2011
AB SANDOZ INC EQ 10MG BASE A077575 001 May 29, 2012
AB EQ 20MG BASE A077575 002 May 29, 2012
AB EQ 40MG BASE A077575 003 May 29, 2012
AB EQ 80MG BASE A077575 004 May 29, 2012
LIPITOR
AB PFIZER EQ 10MG BASE N020702 001 Dec 17, 1996
AB EQ 20MG BASE N020702 002 Dec 17, 1996
AB EQ 40MG BASE N020702 003 Dec 17, 1996
AB + EQ 80MG BASE N020702 004 Apr 07, 2000
ATORVASTATIN CALCIUM; EZETIMIBE
TABLET;ORAL
LIPTRUZET
MERCK SHARP DOHME EQ 10MG BASE;10MG N200153 001 May 03, 2013
EQ 20MG BASE;10MG N200153 002 May 03, 2013
EQ 40MG BASE;10MG N200153 003 May 03, 2013
+ EQ 80MG BASE;10MG N200153 004 May 03, 2013
ATOVAQUONE
SUSPENSION;ORAL
MEPRON
+ GLAXOSMITHKLINE LLC 750MG/5ML N020500 001 Feb 08, 1995
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
TABLET;ORAL
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
AB GLENMARK GENERICS 250MG;100MG A091211 001 Jan 12, 2011
MALARONE
AB + GLAXOSMITHKLINE 250MG;100MG N021078 001 Jul 14, 2000
MALARONE PEDIATRIC
GLAXOSMITHKLINE 62.5MG;25MG N021078 002 Jul 14, 2000
ATRACURIUM BESYLATE
INJECTABLE;INJECTION
ATRACURIUM BESYLATE
AP + BEDFORD 10MG/ML A074901 001 Jul 18, 1997
AP HOSPIRA INC 10MG/ML A090761 001 Oct 18, 2012
AP SAGENT PHARMS 10MG/ML A091489 001 Feb 17, 2012
ATRACURIUM BESYLATE PRESERVATIVE FREE
AP + BEDFORD 10MG/ML A074900 001 Jul 18, 1997
AP HOSPIRA INC 10MG/ML A090782 001 Oct 18, 2012
AP SAGENT PHARMS 10MG/ML A091488 001 Feb 17, 2012
ATROPINE
INJECTABLE;INJECTION
ATROPEN
+ MERIDIAN MEDCL TECHN EQ 0.25MG SULFATE/0.3ML N017106 004 Sep 17, 2004
+ EQ 0.5MG SULFATE/0.7ML N017106 003 Jun 19, 2003
+ EQ 1MG SULFATE/0.7ML N017106 002 Jun 19, 2003
+ EQ 2MG SULFATE/0.7ML N017106 001
ATROPINE SULFATE
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
ATROPINE SULFATE ANSYR PLASTIC SYRINGE
HOSPIRA 0.05MG/ML N021146 002 Jul 09, 2001
+ 0.1MG/ML N021146 001 Jul 09, 2001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-37( of 362)
ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
TABLET;ORAL
MOTOFEN
+ VALEANT 0.025MG;1MG N017744 002
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
SOLUTION;ORAL
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
AA + ROXANE 0.025MG/5ML;2.5MG/5ML A087708 001 May 03, 1982
TABLET;ORAL
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
AA LANNETT 0.025MG;2.5MG A085372 001
AA MYLAN 0.025MG;2.5MG A085762 001
AA PAR PHARM 0.025MG;2.5MG A040357 001 May 02, 2000
LOMOTIL
AA + GD SEARLE LLC 0.025MG;2.5MG N012462 001
LONOX
AA SANDOZ 0.025MG;2.5MG A085311 002
ATROPINE SULFATE; EDROPHONIUM CHLORIDE
INJECTABLE;INJECTION
ENLON-PLUS
+ MYLAN INSTITUTIONAL 0.14MG/ML;10MG/ML N019678 001 Nov 06, 1991
ATROPINE; PRALIDOXIME CHLORIDE
INJECTABLE;INTRAMUSCULAR
DUODOTE
+ MERIDIAN MEDCL 2.1MG/0.7ML;600MG/2ML N021983 001 Sep 28, 2006
AURANOFIN
CAPSULE;ORAL
RIDAURA
+ PROMETHEUS LABS 3MG N018689 001 May 24, 1985
AVANAFIL
TABLET;ORAL
STENDRA
VIVUS 50MG N202276 001 Apr 27, 2012
100MG N202276 002 Apr 27, 2012
+ 200MG N202276 003 Apr 27, 2012
AXITINIB
TABLET;ORAL
INLYTA
PFIZER 1MG N202324 001 Jan 27, 2012
+ 5MG N202324 002 Jan 27, 2012
AZACITIDINE
INJECTABLE;IV-SC
AZACITIDINE
AP DR REDDYS LABS LTD 100MG/VIAL A201537 001 Sep 16, 2013
VIDAZA
AP + CELGENE 100MG/VIAL N050794 001 May 19, 2004
AZATHIOPRINE
TABLET;ORAL
AZASAN
AB AAIPHARMA LLC 25MG A075252 002 Feb 03, 2003
AB 50MG A075252 001 Jun 07, 1999
AB 75MG A075252 003 Feb 03, 2003
AB 100MG A075252 004 Feb 03, 2003
AZATHIOPRINE
AB MYLAN 50MG A075568 001 Dec 13, 1999
AB ROXANE 50MG A074069 001 Feb 16, 1996
AB ZYDUS PHARMS USA 25MG A077621 002 Sep 05, 2008
AB 50MG A077621 001 Mar 15, 2007
AB 75MG A077621 003 Sep 05, 2008
AB 100MG A077621 004 Sep 05, 2008
IMURAN
AB + PROMETHEUS LABS 50MG N016324 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-38( of 362)
AZATHIOPRINE SODIUM
INJECTABLE;INJECTION
AZATHIOPRINE SODIUM
+ BEDFORD EQ 100MG BASE/VIAL A074419 001 Mar 31, 1995
AZELAIC ACID
CREAM;TOPICAL
AZELEX
+ ALLERGAN 20% N020428 001 Sep 13, 1995
GEL;TOPICAL
FINACEA
+ BAYER HLTHCARE 15% N021470 001 Dec 24, 2002
AZELASTINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AZELASTINE HYDROCHLORIDE
AT ALCON PHARMA 0.05% A202305 001 May 31, 2012
AT APOTEX INC 0.05% A078621 001 Aug 03, 2009
AT SUN PHARMA GLOBAL 0.05% A078738 001 Jun 21, 2010
OPTIVAR
AT + MEDA PHARMS 0.05% N021127 001 May 22, 2000
SPRAY, METERED;NASAL
ASTELIN
AB + MEDA PHARMS EQ 0.125MG BASE/SPRAY N020114 001 Nov 01, 1996
ASTEPRO
AB + MEDA PHARMS EQ 0.1876MG BASE/SPRAY N022371 001 Aug 31, 2009
AZELASTINE HYDROCHLORIDE
AB APOTEX INC EQ 0.125MG BASE/SPRAY A077954 001 Apr 30, 2009
AB EQ 0.1876MG BASE/SPRAY A201846 001 Aug 31, 2012
AB SUN PHARMA GLOBAL EQ 0.125MG BASE/SPRAY A090423 001 May 23, 2012
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
SPRAY, METERED;NASAL
DYMISTA
+ MEDA PHARMS EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY N202236 001 May 01, 2012
AZILSARTAN KAMEDOXOMIL
TABLET;ORAL
EDARBI
ARBOR PHARMS LLC EQ 40MG MEDOXOMIL N200796 001 Feb 25, 2011
+ EQ 80MG MEDOXOMIL N200796 002 Feb 25, 2011
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
TABLET;ORAL
EDARBYCLOR
ARBOR PHARMS LLC EQ 40MG MEDOXOMIL;12.5MG N202331 001 Dec 20, 2011
+ EQ 40MG MEDOXOMIL;25MG N202331 002 Dec 20, 2011
AZITHROMYCIN
FOR SUSPENSION;ORAL
AZITHROMYCIN
AB PLIVA EQ 100MG BASE/5ML A065246 002 Jul 05, 2006
AB EQ 200MG BASE/5ML A065246 001 Jul 05, 2006
AB TEVA PHARMS EQ 100MG BASE/5ML A065419 001 Jun 24, 2008
AB EQ 200MG BASE/5ML A065419 002 Jun 24, 2008
ZITHROMAX
AB PFIZER EQ 100MG BASE/5ML N050710 001 Oct 19, 1995
AB + EQ 200MG BASE/5ML N050710 002 Oct 19, 1995
+ EQ 1GM BASE/PACKET N050693 001 Sep 28, 1994
FOR SUSPENSION, EXTENDED RELEASE;ORAL
ZMAX
+ PF PRISM CV EQ 2GM BASE/BOT N050797 001 Jun 10, 2005
INJECTABLE;INJECTION
AZITHROMYCIN
AP FRESENIUS KABI USA EQ 500MG BASE/VIAL A065179 001 Dec 13, 2005
AP GLAND PHARMA LTD EQ 500MG BASE/VIAL A065501 001 Nov 09, 2009
AP HOSPIRA EQ 500MG BASE/VIAL A065500 001 Jun 26, 2009
AP EQ 500MG BASE/VIAL A065511 001 Jun 26, 2009
AP SAGENT STRIDES EQ 500MG BASE/VIAL A065506 001 Mar 24, 2009
AP SUN PHARM INDS LTD EQ 500MG BASE/VIAL A090923 001 Apr 02, 2013
ZITHROMAX
AP + PFIZER EQ 500MG BASE/VIAL N050733 001 Jan 30, 1997
SOLUTION/DROPS;OPHTHALMIC
AZASITE
+ OAK PHARMS AKORN 1% N050810 001 Apr 27, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-39( of 362)
AZITHROMYCIN
TABLET;ORAL
AZITHROMYCIN
AB APOTEX CORP EQ 250MG BASE A065507 001 Jul 13, 2011
AB EQ 500MG BASE A065509 001 Jul 13, 2011
AB EQ 600MG BASE A065508 001 Jul 13, 2011
AB MYLAN EQ 250MG BASE A065365 001 May 30, 2007
AB EQ 500MG BASE A065366 001 May 30, 2007
AB EQ 600MG BASE A065360 001 Jan 08, 2007
AB PLIVA EQ 250MG BASE A065225 001 Nov 14, 2005
AB EQ 500MG BASE A065223 001 Nov 14, 2005
AB EQ 600MG BASE A065218 001 Nov 14, 2005
AB SANDOZ EQ 250MG BASE A065211 001 Nov 14, 2005
AB EQ 500MG BASE A065212 001 Nov 14, 2005
AB EQ 600MG BASE A065209 001 Nov 14, 2005
AB TEVA EQ 250MG BASE A065153 001 Nov 14, 2005
AB EQ 500MG BASE A065193 001 Nov 14, 2005
AB EQ 600MG BASE A065150 001 Nov 14, 2005
AB WOCKHARDT EQ 250MG BASE A065404 001 Feb 11, 2008
AB EQ 500MG BASE A065405 001 Feb 11, 2008
AB EQ 600MG BASE A065302 003 Feb 11, 2008
ZITHROMAX
AB PFIZER EQ 250MG BASE N050711 001 Jul 18, 1996
AB EQ 500MG BASE N050784 001 May 24, 2002
AB + EQ 600MG BASE N050730 001 Jun 12, 1996
AZTREONAM
FOR SOLUTION;INHALATION
CAYSTON
+ GILEAD 75MG/VIAL N050814 001 Feb 22, 2010
INJECTABLE;INJECTION
AZACTAM
AP + BRISTOL MYERS SQUIBB 1GM/VIAL N050580 002 Dec 31, 1986
AP + 2GM/VIAL N050580 003 Dec 31, 1986
AZTREONAM
AP BEDFORD 1GM/VIAL A065286 001 Mar 23, 2011
AP 2GM/VIAL A065286 002 Mar 23, 2011
AP FRESENIUS KABI USA 1GM/VIAL A065439 002 Jun 18, 2010
AP 2GM/VIAL A065439 003 Jun 18, 2010
AZACTAM IN PLASTIC CONTAINER
+ BRISTOL MYERS SQUIBB 20MG/ML N050632 002 May 24, 1989
+ 40MG/ML N050632 001 May 24, 1989
AZTREONAM
FRESENIUS KABI USA 500MG/VIAL A065439 001 Jun 18, 2010
BACITRACIN
INJECTABLE;INJECTION
BACIIM
AP X GEN PHARMS 50,000 UNITS/VIAL A064153 001 May 09, 1997
BACITRACIN
AP FRESENIUS KABI USA 50,000 UNITS/VIAL A065116 001 Dec 03, 2002
AP + PHARMACIA AND UPJOHN 50,000 UNITS/VIAL A060733 002
AP SAGENT STRIDES 50,000 UNITS/VIAL A090211 001 May 11, 2010
PHARMACIA AND UPJOHN 10,000 UNITS/VIAL A060733 001
OINTMENT;OPHTHALMIC
BACITRACIN
AT AKORN 500 UNITS/GM A203257 001 Dec 13, 2013
AT + PERRIGO CO TENNESSEE 500 UNITS/GM A061212 001
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
AT AKORN 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 A065213 001 Jul 25, 2012
UNITS/GM
AT + BAUSCH AND LOMB 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 A064068 001 Oct 30, 1995
UNITS/GM
OINTMENT;TOPICAL
CORTISPORIN
+ MONARCH PHARMS 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 N050168 002 May 04, 1984
UNITS/GM
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-40( of 362)
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
AT AKORN 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 A065088 001 Feb 06, 2004
UNITS/GM
AT + BAUSCH AND LOMB 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 A064064 001 Oct 30, 1995
UNITS/GM
AT PERRIGO CO TENNESSEE 400 UNITS/GM;EQ 3.5MG BASE;10,000 A060764 002
UNITS/GM
BACITRACIN ZINC; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
BACITRACIN ZINC AND POLYMYXIN B SULFATE
AT AKORN 500 UNITS/GM;10,000 UNITS/GM A064028 001 Jan 30, 1995
AT + BAUSCH AND LOMB 500 UNITS/GM;10,000 UNITS/GM A064046 001 Jan 26, 1995
AT PERRIGO CO TENNESSEE 500 UNITS/GM;10,000 UNITS/GM A065022 001 Feb 27, 2002
BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
+ PERRIGO CO TENNESSEE 400 UNITS/GM;1%;EQ 3.5MG BASE;10,000 A062166 002
UNITS/GM
BACLOFEN
INJECTABLE;INTRATHECAL
GABLOFEN
AP MALLINCKRODT INC 0.05MG/ML N022462 001 Nov 19, 2010
AP 0.5MG/ML N022462 002 Nov 19, 2010
AP 2MG/ML N022462 003 Nov 19, 2010
LIORESAL
AP + MEDTRONIC NEURO 0.05MG/ML N020075 003 Nov 07, 1996
AP + 0.5MG/ML N020075 001 Jun 17, 1992
AP + 2MG/ML N020075 002 Jun 17, 1992
GABLOFEN
MALLINCKRODT INC 1MG/ML N022462 004 Jun 22, 2012
TABLET;ORAL
BACLOFEN
AB CARACO 10MG A077984 001 Aug 14, 2006
AB 20MG A077862 002 Aug 14, 2006
AB IMPAX LABS 10MG A078146 001 Oct 26, 2007
AB 20MG A077971 002 Oct 26, 2007
AB IVAX SUB TEVA PHARMS 10MG A072234 001 Jul 21, 1988
AB + 20MG A072235 001 Jul 21, 1988
AB LANNETT 10MG A078220 001 Jul 06, 2007
AB 20MG A077241 001 Dec 20, 2005
AB MYLAN 10MG A077181 001 Jul 29, 2005
AB 20MG A077121 002 Jul 29, 2005
AB MYLAN PHARMS INC 10MG A090334 001 Feb 18, 2010
AB 20MG A090334 002 Feb 18, 2010
AB NORTHSTAR HLTHCARE 10MG A078504 001 Sep 18, 2009
AB 20MG A078401 001 Sep 18, 2009
AB PROSAM LABS 10MG A077089 001 Oct 31, 2007
AB 20MG A077088 001 Oct 31, 2007
AB USL PHARMA 10MG A074584 001 Aug 19, 1996
AB 20MG A074584 002 Aug 19, 1996
AB VINTAGE PHARMS 10MG A077156 001 Aug 30, 2005
AB 20MG A077068 001 Aug 30, 2005
AB WATSON LABS 10MG A072824 001 Sep 18, 1991
AB 20MG A072825 001 Sep 18, 1991
BALSALAZIDE DISODIUM
CAPSULE;ORAL
BALSALAZIDE DISODIUM
AB APOTEX INC 750MG A077883 001 Dec 28, 2007
AB MYLAN 750MG A077807 001 Dec 28, 2007
AB ROXANE 750MG A077806 001 Dec 28, 2007
COLAZAL
AB + SALIX PHARMS 750MG N020610 001 Jul 18, 2000
TABLET;ORAL
GIAZO
+ SALIX PHARMS 1.1GM N022205 001 Feb 03, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-41( of 362)
BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED
TABLET;ORAL
DUAVEE
+ WYETH PHARMS PFIZER EQ 20MG BASE;0.45MG N022247 001 Oct 03, 2013
BECLOMETHASONE DIPROPIONATE
AEROSOL, METERED;INHALATION
QVAR 40
+ TEVA BRANDED PHARM 0.04MG/INH N020911 002 Sep 15, 2000
QVAR 80
+ TEVA BRANDED PHARM 0.08MG/INH N020911 001 Sep 15, 2000
AEROSOL, METERED;NASAL
QNASL
+ TEVA BRANDED PHARM 0.08MG/ACTUATION N202813 001 Mar 23, 2012
BECLOMETHASONE DIPROPIONATE MONOHYDRATE
SPRAY, METERED;NASAL
BECONASE AQ
+ GLAXOSMITHKLINE EQ 0.042MG DIPROP/SPRAY N019389 001 Jul 27, 1987
BEDAQUILINE FUMARATE
TABLET;ORAL
SIRTURO
+ JANSSEN THERAP EQ 100MG BASE N204384 001 Dec 28, 2012
BENAZEPRIL HYDROCHLORIDE
TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE
AB APOTEX INC 5MG A077128 001 Mar 08, 2006
AB 10MG A077128 002 Mar 08, 2006
AB 20MG A077128 003 Mar 08, 2006
AB 40MG A077128 004 Mar 08, 2006
AB AUROBINDO PHARMA 10MG A078212 001 May 22, 2008
AB 20MG A078212 002 May 22, 2008
AB 40MG A078212 003 May 22, 2008
AB BIOKEY 5MG A076820 001 Feb 03, 2006
AB 10MG A076820 002 Feb 03, 2006
AB 20MG A076820 003 Feb 03, 2006
AB 40MG A076820 004 Feb 03, 2006
AB IVAX SUB TEVA PHARMS 5MG A076333 001 Feb 11, 2004
AB 10MG A076333 002 Feb 11, 2004
AB 20MG A076333 003 Feb 11, 2004
AB 40MG A076333 004 Feb 11, 2004
AB MYLAN 5MG A076430 001 Feb 11, 2004
AB 10MG A076430 002 Feb 11, 2004
AB 20MG A076430 003 Feb 11, 2004
AB 40MG A076430 004 Feb 11, 2004
AB PRINSTON INC 5MG A076118 001 Feb 11, 2004
AB 10MG A076118 002 Feb 11, 2004
AB 20MG A076118 003 Feb 11, 2004
AB 40MG A076118 004 Feb 11, 2004
AB RANBAXY 5MG A076344 001 Feb 11, 2004
AB 10MG A076344 002 Feb 11, 2004
AB 20MG A076344 003 Feb 11, 2004
AB 40MG A076344 004 Feb 11, 2004
AB SANDOZ 5MG A076402 001 Feb 11, 2004
AB 10MG A076402 002 Feb 11, 2004
AB 20MG A076402 003 Feb 11, 2004
AB 40MG A076402 004 Feb 11, 2004
AB TEVA 5MG A076211 001 Feb 11, 2004
AB 10MG A076211 002 Feb 11, 2004
AB 20MG A076211 003 Feb 11, 2004
AB 40MG A076211 004 Feb 11, 2004
AB WATSON LABS FLORIDA 5MG A076267 001 Feb 11, 2004
AB 10MG A076267 002 Feb 11, 2004
AB 20MG A076267 003 Feb 11, 2004
AB 40MG A076267 004 Feb 11, 2004
AB ZYDUS PHARMS USA 5MG A078848 001 May 23, 2008
AB 10MG A078848 002 May 23, 2008
AB 20MG A078848 003 May 23, 2008
AB 40MG A078848 004 May 23, 2008
LOTENSIN
AB US PHARMS HOLDINGS I 5MG N019851 001 Jun 25, 1991
AB 10MG N019851 002 Jun 25, 1991
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-42( of 362)
BENAZEPRIL HYDROCHLORIDE
TABLET;ORAL
LOTENSIN
AB 20MG N019851 003 Jun 25, 1991
AB + 40MG N019851 004 Jun 25, 1991
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB IVAX SUB TEVA PHARMS 5MG;6.25MG A076348 001 Feb 11, 2004
AB 10MG;12.5MG A076348 002 Feb 11, 2004
AB 20MG;12.5MG A076348 003 Feb 11, 2004
AB 20MG;25MG A076348 004 Feb 11, 2004
AB MYLAN 5MG;6.25MG A076688 001 Feb 11, 2004
AB 10MG;12.5MG A076688 002 Feb 11, 2004
AB 20MG;12.5MG A076688 003 Feb 11, 2004
AB 20MG;25MG A076688 004 Feb 11, 2004
AB RANBAXY 5MG;6.25MG A077483 001 Sep 08, 2005
AB 10MG;12.5MG A077483 002 Sep 08, 2005
AB 20MG;12.5MG A077483 003 Sep 08, 2005
AB 20MG;25MG A077483 004 Sep 08, 2005
AB SANDOZ 5MG;6.25MG A076631 001 Feb 11, 2004
AB 10MG;12.5MG A076631 002 Feb 11, 2004
AB 20MG;12.5MG A076631 003 Feb 11, 2004
AB 20MG;25MG A076631 004 Feb 11, 2004
AB WATSON LABS FLORIDA 5MG;6.25MG A076342 001 Feb 11, 2004
AB 10MG;12.5MG A076342 002 Feb 11, 2004
AB 20MG;12.5MG A076342 003 Feb 11, 2004
AB 20MG;25MG A076342 004 Feb 11, 2004
LOTENSIN HCT
AB US PHARMS HOLDINGS I 5MG;6.25MG N020033 001 May 19, 1992
AB 10MG;12.5MG N020033 002 May 19, 1992
AB 20MG;12.5MG N020033 004 May 19, 1992
AB + 20MG;25MG N020033 003 May 19, 1992
BENDAMUSTINE HYDROCHLORIDE
POWDER;IV (INFUSION)
TREANDA
+ CEPHALON 25MG/VIAL N022249 002 May 01, 2009
+ 100MG/VIAL N022249 001 Mar 20, 2008
SOLUTION;IV (INFUSION)
TREANDA
+ CEPHALON 45MG/0.5ML (90MG/ML) N022249 003 Sep 13, 2013
+ 180MG/2ML (90MG/ML) N022249 004 Sep 13, 2013
BENDROFLUMETHIAZIDE; NADOLOL
TABLET;ORAL
CORZIDE
AB KING PHARMS 5MG;40MG N018647 001 May 25, 1983
AB + 5MG;80MG N018647 002 May 25, 1983
NADOLOL AND BENDROFLUMETHAZIDE
AB MYLAN 5MG;40MG A078688 001 Feb 15, 2008
AB 5MG;80MG A078688 002 Feb 15, 2008
NADOLOL AND BENDROFLUMETHIAZIDE
AB IMPAX LABS 5MG;40MG A077833 001 Mar 30, 2007
AB 5MG;80MG A077833 002 Mar 30, 2007
BENZONATATE
CAPSULE;ORAL
BENZONATATE
AA BANNER PHARMACAPS 100MG A081297 001 Jan 29, 1993
AA 200MG A081297 002 Oct 30, 2007
AA CARACO 100MG A040587 001 Mar 19, 2008
AA 200MG A040587 002 Mar 19, 2008
AA MIKART 100MG A040851 001 Nov 09, 2009
AA 200MG A040851 003 Nov 09, 2009
AA ORIT LABS LLC 100MG A040682 001 Jul 30, 2007
AA 200MG A040682 002 Jul 30, 2007
AA THE PHARMA NETWORK 100MG A040627 001 Mar 30, 2007
AA 200MG A040749 001 Jul 25, 2007
AA ZYDUS PHARMS USA 100MG A040597 001 Jun 08, 2007
AA 200MG A040597 002 Jun 08, 2007
TESSALON
AA + PFIZER 100MG N011210 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-43( of 362)
BENZONATATE
CAPSULE;ORAL
TESSALON
AA + 200MG N011210 003 Jun 25, 1999
BENZONATATE
MIKART 150MG A040851 002 Nov 09, 2009
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
GEL;TOPICAL
BENZACLIN
AB VALEANT BERMUDA 5%;EQ 1% BASE N050756 001 Dec 21, 2000
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
AB MYLAN PHARMS INC 5%;EQ 1% BASE A065443 001 Aug 11, 2009
AB PERRIGO ISRAEL 5%;1.2% A090979 001 Jun 26, 2012
DUAC
AB + STIEFEL 5%;1.2% N050741 001 Aug 26, 2002
BENZACLIN
BT + VALEANT BERMUDA 5%;EQ 1% BASE N050756 002 Apr 20, 2007
ACANYA
+ DOW PHARM 2.5%;1.2% N050819 001 Oct 23, 2008
BENZOYL PEROXIDE; ERYTHROMYCIN
GEL;TOPICAL
BENZAMYCIN
AB + VALEANT INTL 5%;3% N050557 001 Oct 26, 1984
ERYTHROMYCIN AND BENZOYL PEROXIDE
AB TOLMAR 5%;3% A065112 001 Mar 29, 2004
BENZAMYCIN PAK
+ VALEANT LUXEMBOURG 5%;3% N050769 001 Nov 27, 2000
BENZPHETAMINE HYDROCHLORIDE
TABLET;ORAL
BENZPHETAMINE HYDROCHLORIDE
AA EMCURE PHARMS LTD 50MG A202061 001 Jan 27, 2012
AA IMPAX LABS 50MG A040845 001 Nov 18, 2008
AA KVK TECH 50MG A090968 001 Jul 20, 2010
AA MALLINCKRODT INC 50MG A040773 001 Apr 25, 2007
AA MIKART 25MG A090473 001 Sep 15, 2010
AA 50MG A090473 002 Sep 15, 2010
AA PADDOCK 50MG A040578 001 Apr 17, 2006
AA TEDOR PHARM 50MG A040747 001 Mar 30, 2007
DIDREX
AA + PHARMACIA AND UPJOHN 50MG N012427 002
BENZTROPINE MESYLATE
INJECTABLE;INJECTION
BENZTROPINE MESYLATE
AP FRESENIUS KABI USA 1MG/ML A090233 001 Jul 28, 2009
AP HIKMA FARMACEUTICA 1MG/ML A090287 001 Aug 31, 2009
AP LUITPOLD 1MG/ML A091152 001 Mar 29, 2010
AP NAVINTA LLC 1MG/ML A091525 001 Feb 05, 2013
COGENTIN
AP + OAK PHARMS AKORN 1MG/ML N012015 001
TABLET;ORAL
BENZTROPINE MESYLATE
AA COREPHARMA 0.5MG A072264 001 Feb 27, 1989
AA 1MG A072265 001 Feb 27, 1989
AA 2MG A072266 001 Feb 27, 1989
AA EXCELLIUM 0.5MG A090168 001 Nov 28, 2012
AA 1MG A090168 002 Nov 28, 2012
AA 2MG A090168 003 Nov 28, 2012
AA INVAGEN PHARMS 0.5MG A090294 001 Mar 29, 2010
AA 1MG A090294 002 Mar 29, 2010
AA 2MG A090294 003 Mar 29, 2010
AA PLIVA 0.5MG A089058 001 Aug 10, 1988
AA 1MG A089059 001 Aug 10, 1988
AA 2MG A089060 001 Aug 10, 1988
AA + USL PHARMA 0.5MG A040103 001 Dec 12, 1996
AA + 1MG A040103 002 Dec 12, 1996
AA + 2MG A040103 003 Dec 12, 1996
AA VINTAGE 0.5MG A040738 001 Aug 27, 2007
AA 1MG A040742 001 Aug 27, 2007
AA 2MG A040715 003 Aug 27, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-44( of 362)
BENZYL ALCOHOL
LOTION;TOPICAL
ULESFIA
+ SHIONOGI INC 5% N022129 001 Apr 09, 2009
BENZYLPENICILLOYL POLYLYSINE
INJECTABLE;INJECTION
PRE-PEN
+ ALLERQUEST 60UMOLAR N050114 001
BEPOTASTINE BESILATE
SOLUTION/DROPS;OPHTHALMIC
BEPREVE
+ ISTA PHARMS INC 1.5% N022288 001 Sep 08, 2009
BERACTANT
SUSPENSION;INTRATRACHEAL
SURVANTA
+ ABBVIE 25MG/ML N020032 001 Jul 01, 1991
BESIFLOXACIN HYDROCHLORIDE
SUSPENSION/DROPS;OPHTHALMIC
BESIVANCE
+ BAUSCH AND LOMB EQ 0.6% BASE N022308 001 May 28, 2009
BETAINE HYDROCHLORIDE
FOR SOLUTION;ORAL
CYSTADANE
+ RARE DIS THERAP 1GM/SCOOPFUL N020576 001 Oct 25, 1996
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
AB LUITPOLD 3MG/ML;EQ 3MG BASE/ML A090747 001 Jul 31, 2009
CELESTONE SOLUSPAN
AB + MERCK SHARP DOHME 3MG/ML;EQ 3MG BASE/ML N014602 001
BETAMETHASONE DIPROPIONATE
CREAM;TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A070885 001 Feb 03, 1987
AB + FOUGERA PHARMS EQ 0.05% BASE N019137 001 Jun 26, 1984
AB TARO EQ 0.05% BASE A073552 001 Apr 30, 1992
CREAM, AUGMENTED;TOPICAL
BETAMETHASONE DIPROPIONATE
AB FOUGERA PHARMS EQ 0.05% BASE A076215 001 Dec 09, 2003
AB GLENMARK GENERICS EQ 0.05% BASE A078930 001 Sep 23, 2008
AB PERRIGO NEW YORK EQ 0.05% BASE A076592 001 Dec 09, 2003
AB TARO EQ 0.05% BASE A076543 001 Dec 09, 2003
AB TOLMAR EQ 0.05% BASE A076603 001 Jan 23, 2004
DIPROLENE AF
AB + MERCK SHARP DOHME EQ 0.05% BASE N019555 001 Apr 27, 1987
GEL, AUGMENTED;TOPICAL
BETAMETHASONE DIPROPIONATE
AB + FOUGERA PHARMS EQ 0.05% BASE A075276 001 May 13, 2003
AB TARO EQ 0.05% BASE A076508 001 Dec 02, 2003
LOTION;TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A070281 001 Jul 31, 1985
AB + FOUGERA EQ 0.05% BASE A070275 001 Aug 12, 1985
AB PERRIGO NEW YORK EQ 0.05% BASE A072538 001 Jan 31, 1990
AB TEVA EQ 0.05% BASE A071467 001 Aug 10, 1987
LOTION, AUGMENTED;TOPICAL
BETAMETHASONE DIPROPIONATE
AB FOUGERA PHARMS EQ 0.05% BASE A077111 001 May 21, 2007
AB TARO EQ 0.05% BASE A077477 001 May 21, 2007
DIPROLENE
AB + MERCK SHARP DOHME EQ 0.05% BASE N019716 001 Aug 01, 1988
OINTMENT;TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A071012 001 Feb 03, 1987
AB + FOUGERA EQ 0.05% BASE N019141 001 Sep 04, 1984
AB TARO EQ 0.05% BASE A074271 001 Sep 15, 1994
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-45( of 362)
BETAMETHASONE DIPROPIONATE
OINTMENT, AUGMENTED;TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A074304 001 Aug 31, 1995
AB FOUGERA PHARMS EQ 0.05% BASE A075373 001 Jun 22, 1999
AB TARO EQ 0.05% BASE A076753 001 Oct 12, 2004
DIPROLENE
AB + MERCK SHARP DOHME EQ 0.05% BASE N018741 001 Jul 27, 1983
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE
OINTMENT;TOPICAL
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
AB TOLMAR 0.064%;0.005% A201615 001 Jan 14, 2013
TACLONEX
AB + LEO PHARMA AS 0.064%;0.005% N021852 001 Jan 09, 2006
SUSPENSION;TOPICAL
TACLONEX
+ LEO PHARMA AS 0.064%;0.005% N022185 001 May 09, 2008
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
CREAM;TOPICAL
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE;1% A076002 001 Aug 02, 2002
AB FOUGERA PHARMS EQ 0.05% BASE;1% A075502 001 Jun 05, 2001
AB TARO EQ 0.05% BASE;1% A075673 001 May 29, 2001
LOTRISONE
AB + MERCK SHARP DOHME EQ 0.05% BASE;1% N018827 001 Jul 10, 1984
LOTION;TOPICAL
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
AB FOUGERA PHARMS EQ 0.05% BASE;1% A076516 001 Jun 16, 2005
AB TARO EQ 0.05% BASE;1% A076493 001 Jul 28, 2004
LOTRISONE
AB + SCHERING CORP EQ 0.05% BASE;1% N020010 001 Dec 08, 2000
BETAMETHASONE VALERATE
AEROSOL, FOAM;TOPICAL
BETAMETHASONE VALERATE
AB PERRIGO 0.12% A078337 001 Nov 26, 2012
LUXIQ
AB + DELCOR ASSET 0.12% N020934 001 Feb 28, 1999
CREAM;TOPICAL
BETA-VAL
AB TEVA EQ 0.1% BASE N018642 001 Mar 24, 1983
BETAMETHASONE VALERATE
AB + FOUGERA EQ 0.1% BASE N018861 001 Aug 31, 1983
DERMABET
AB TARO EQ 0.1% BASE A072041 001 Jan 06, 1988
VALNAC
AB ACTAVIS MID ATLANTIC EQ 0.1% BASE A070050 001 Oct 10, 1984
LOTION;TOPICAL
BETA-VAL
AB TEVA EQ 0.1% BASE A070072 001 Jun 27, 1985
BETAMETHASONE VALERATE
AB + FOUGERA EQ 0.1% BASE N018866 001 Aug 31, 1983
AB STI PHARMA LLC EQ 0.1% BASE A070052 001 Jul 31, 1985
OINTMENT;TOPICAL
BETAMETHASONE VALERATE
AB ACTAVIS MID ATLANTIC EQ 0.1% BASE A070051 001 Oct 10, 1984
AB + FOUGERA EQ 0.1% BASE N018865 001 Aug 31, 1983
BETAXOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
BETAXOLOL HYDROCHLORIDE
AT AKORN EQ 0.5% BASE A075386 001 Jun 30, 2000
AT BAUSCH AND LOMB EQ 0.5% BASE A075630 001 Apr 12, 2001
AT WOCKHARDT EQ 0.5% BASE A078694 001 Nov 16, 2009
BETOPTIC
AT + ALCON EQ 0.5% BASE N019270 001 Aug 30, 1985
SUSPENSION/DROPS;OPHTHALMIC
BETOPTIC S
+ ALCON EQ 0.25% BASE N019845 001 Dec 29, 1989
TABLET;ORAL
BETAXOLOL HYDROCHLORIDE
AB EPIC PHARMA 10MG A075541 001 Oct 22, 1999
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-46( of 362)
BETAXOLOL HYDROCHLORIDE
TABLET;ORAL
BETAXOLOL HYDROCHLORIDE
AB + 20MG A075541 002 Oct 22, 1999
AB KVK TECH 10MG A078962 001 Jun 27, 2008
AB 20MG A078962 002 Jun 27, 2008
BETHANECHOL CHLORIDE
TABLET;ORAL
BETHANECHOL CHLORIDE
AA AMNEAL PHARM 5MG A040855 001 Nov 21, 2007
AA 10MG A040855 002 Nov 21, 2007
AA 25MG A040855 003 Nov 21, 2007
AA 50MG A040855 004 Nov 21, 2007
AA CARACO 5MG A040897 001 Apr 22, 2009
AA 10MG A040897 002 Apr 22, 2009
AA 25MG A040897 003 Apr 22, 2009
AA 50MG A040897 004 Apr 22, 2009
AA EMCURE USA 5MG A091256 001 May 04, 2010
AA 10MG A091256 002 May 04, 2010
AA 25MG A091256 003 May 04, 2010
AA 50MG A091256 004 May 04, 2010
AA IMPAX LABS 5MG A040739 001 Nov 01, 2006
AA 10MG A040741 001 Nov 01, 2006
AA 25MG A040740 001 Nov 01, 2006
AA 50MG A040721 004 Nov 01, 2006
AA LANNETT 10MG A040704 001 Mar 27, 2008
AA 25MG A040678 003 Mar 27, 2008
AA PHARMAX 5MG A040725 001 Oct 26, 2007
AA 10MG A040726 001 Oct 26, 2007
AA 25MG A040727 001 Oct 26, 2007
AA 50MG A040728 001 Oct 26, 2007
AA UPSHER SMITH 5MG A040633 001 Jun 01, 2005
AA 10MG A040634 001 Jun 01, 2005
AA 25MG A040635 001 Jun 01, 2005
AA 50MG A040636 001 Jun 01, 2005
AA WOCKHARDT 5MG A040532 001 Sep 29, 2003
AA 10MG A040533 001 Sep 29, 2003
AA 25MG A040534 001 Sep 29, 2003
AA 50MG A040518 001 Sep 29, 2003
DUVOID
AA WELLSPRING PHARM 10MG A086262 001
AA 25MG A086263 001
AA 50MG A085882 003
URECHOLINE
AA + ODYSSEY PHARMS 5MG A089095 001 Dec 19, 1985
AA + 10MG A088440 001 May 29, 1984
AA + 25MG A088441 001 May 29, 1984
AA + 50MG A089096 001 Dec 19, 1985
BEXAROTENE
CAPSULE;ORAL
TARGRETIN
+ VALEANT LUXEMBOURG 75MG N021055 001 Dec 29, 1999
GEL;TOPICAL
TARGRETIN
+ VALEANT LUXEMBOURG 1% N021056 001 Jun 28, 2000
BICALUTAMIDE
TABLET;ORAL
BICALUTAMIDE
AB ACCORD HLTHCARE 50MG A078917 001 Jul 06, 2009
AB ACTAVIS TOTOWA 50MG A078634 001 Aug 28, 2009
AB FRESENIUS KABI ONCOL 50MG A079045 001 May 13, 2010
AB MYLAN 50MG A079185 001 Jul 06, 2009
AB ROXANE 50MG A078285 001 Mar 24, 2011
AB SANDOZ 50MG A078575 001 Jul 06, 2009
AB SUN PHARMA GLOBAL 50MG A079110 001 Jul 06, 2009
AB TEVA 50MG A076932 001 Jul 06, 2009
AB ZYDUS PHARMS USA INC 50MG A079089 001 Jul 06, 2009
CASODEX
AB + ASTRAZENECA 50MG N020498 001 Oct 04, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-47( of 362)
BIMATOPROST
SOLUTION/DROPS;OPHTHALMIC
LUMIGAN
+ ALLERGAN
+
SOLUTION/DROPS;TOPICAL
LATISSE
+ ALLERGAN
BIPERIDEN HYDROCHLORIDE
TABLET;ORAL
AKINETON
+ ABBVIE
0.01%
0.03%
N022184 001
N021275 001
Aug 31, 2010
Mar 16, 2001
0.03% N022369 001 Dec 24, 2008
2MG N012003 001
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL
HALFLYTELY
+ BRAINTREE 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM
;N/A,5.6GM
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE
CAPSULE;ORAL
PYLERA
+ APTALIS PHARMA US 140MG;125MG;125MG
BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
TABLET, CHEWABLE, TABLET, CAPSULE;ORAL
HELIDAC
+ PROMETHEUS LABS 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,5
00MG
BISOPROLOL FUMARATE
TABLET;ORAL
BISOPROLOL FUMARATE
AB AUROBINDO PHARMA 5MG
AB 10MG
AB MYLAN 5MG
AB 10MG
AB SANDOZ 5MG
AB 10MG
AB TEVA PHARMS 5MG
AB 10MG
AB
AB
UNICHEM PHARMS (USA) 5MG
10MG
ZEBETA
AB TEVA WOMENS 5MG
AB + 10MG
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
AB MYLAN
AB
AB
AB SANDOZ
AB
AB
AB UNICHEM
AB
AB
AB WATSON LABS
AB
AB
ZIAC
AB TEVA WOMENS
AB
AB +
BIVALIRUDIN
INJECTABLE;INTRAVENOUS
ANGIOMAX
+ MEDICINES CO
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
250MG/VIAL
N021551 003 Jul 16, 2010
N050786 001 Sep 28, 2006
N050719 001 Aug 15, 1996
A077910 001 Dec 27, 2006
A077910 002 Dec 27, 2006
A075831 001 Dec 14, 2005
A075831 002 Dec 14, 2005
A075643 001 Nov 16, 2000
A075643 002 Nov 16, 2000
A075644 001 Jun 26, 2001
A075644 002 Jun 26, 2001
A078635 001 Aug 18, 2009
A078635 002 Aug 18, 2009
N019982 002 Jul 31, 1992
N019982 001 Jul 31, 1992
A075768 001 Sep 25, 2000
A075768 002 Sep 25, 2000
A075768 003 Sep 25, 2000
A075579 001 Sep 25, 2000
A075579 002 Sep 25, 2000
A075579 003 Sep 25, 2000
A079106 001 Jul 28, 2010
A079106 002 Jul 28, 2010
A079106 003 Jul 28, 2010
A075469 001 Sep 25, 2000
A075469 002 Sep 25, 2000
A075469 003 Sep 25, 2000
N020186 003 Mar 26, 1993
N020186 001 Mar 26, 1993
N020186 002 Mar 26, 1993
N020873 001 Dec 15, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-48( of 362)
BLEOMYCIN SULFATE
INJECTABLE;INJECTION
BLEOMYCIN SULFATE
AP BEDFORD EQ 15 UNITS BASE/VIAL A065042 002 Oct 17, 2001
AP EQ 30 UNITS BASE/VIAL A065042 001 Oct 17, 2001
AP + FRESENIUS KABI USA EQ 15 UNITS BASE/VIAL A065185 001 Jan 28, 2008
AP + EQ 30 UNITS BASE/VIAL A065185 002 Jan 28, 2008
AP HOSPIRA EQ 15 UNITS BASE/VIAL A065031 001 Mar 10, 2000
AP EQ 30 UNITS BASE/VIAL A065031 002 Mar 10, 2000
AP TEVA PHARMS USA EQ 15 UNITS BASE/VIAL A065033 001 Jun 27, 2000
AP EQ 30 UNITS BASE/VIAL A065033 002 Jun 27, 2000
BOCEPREVIR
CAPSULE;ORAL
VICTRELIS
+ MERCK SHARP DOHME 200MG N202258 001 May 13, 2011
BORTEZOMIB
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
VELCADE
+ MILLENNIUM PHARMS 3.5MG/VIAL N021602 001 May 13, 2003
BOSENTAN
TABLET;ORAL
TRACLEER
ACTELION PHARMS LTD 62.5MG N021290 001 Nov 20, 2001
+ 125MG N021290 002 Nov 20, 2001
BOSUTINIB MONOHYDRATE
TABLET;ORAL
BOSULIF
WYETH PHARMS INC EQ 100MG BASE N203341 001 Sep 04, 2012
+ EQ 500MG BASE N203341 002 Sep 04, 2012
BRETYLIUM TOSYLATE
INJECTABLE;INJECTION
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
+ B BRAUN 100MG/100ML N019121 001 Apr 29, 1986
+ 200MG/100ML N019121 002 Apr 29, 1986
+ 400MG/100ML N019121 003 Apr 29, 1986
BRIMONIDINE TARTRATE
GEL;TOPICAL
MIRVASO
+ GALDERMA LABS LP EQ 0.33% BASE N204708 001 Aug 23, 2013
SOLUTION/DROPS;OPHTHALMIC
ALPHAGAN P
AT + ALLERGAN 0.15% N021262 001 Mar 16, 2001
BRIMONIDINE TARTRATE
AT AKORN 0.2% A076439 001 Mar 14, 2006
AT ALCON PHARMS LTD 0.2% A076254 001 Sep 16, 2003
AT + BAUSCH AND LOMB 0.2% A076260 001 May 28, 2003
AT SANDOZ 0.2% A078075 001 Jan 30, 2008
QOLIANA
AT ALCON PHARMS LTD 0.15% N021764 001 May 22, 2006
ALPHAGAN P
+ ALLERGAN 0.1% N021770 001 Aug 19, 2005
BRIMONIDINE TARTRATE; BRINZOLAMIDE
SUSPENSION/DROPS;OPHTHALMIC
SIMBRINZA
+ ALCON RES LTD 0.2%;1% N204251 001 Apr 19, 2013
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC
COMBIGAN
+ ALLERGAN 0.2%;EQ 0.5% BASE N021398 001 Oct 30, 2007
BRINZOLAMIDE
SUSPENSION/DROPS;OPHTHALMIC
AZOPT
+ ALCON PHARMS LTD 1% N020816 001 Apr 01, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-49( of 362)
BROMFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC
BROMFENAC SODIUM
AT COASTAL PHARMS EQ 0.09% ACID A201211 001 May 11, 2011
AT LUITPOLD EQ 0.09% ACID A202030 001 Jan 09, 2013
BROMDAY
+ ISTA PHARMS INC EQ 0.09% ACID N021664 002 Oct 16, 2010
PROLENSA
+ BAUSCH AND LOMB EQ 0.07% ACID N203168 001 Apr 05, 2013
BROMOCRIPTINE MESYLATE
CAPSULE;ORAL
BROMOCRIPTINE MESYLATE
AB MYLAN EQ 5MG BASE A077226 001 Apr 04, 2005
AB ZYDUS PHARMS USA INC EQ 5MG BASE A078899 001 Jul 30, 2008
PARLODEL
AB + US PHARMS HOLDINGS I EQ 5MG BASE N017962 002 Mar 01, 1982
TABLET;ORAL
BROMOCRIPTINE MESYLATE
AB
AB
AB
LEK PHARMS
MYLAN
PADDOCK LLC
PARLODEL
EQ 2.5MG BASE
EQ 2.5MG BASE
EQ 2.5MG BASE
A074631 001 Jan 13, 1998
A076962 001 Sep 24, 2004
A077646 001 Oct 01, 2008
AB + US PHARMS HOLDINGS I
CYCLOSET
EQ 2.5MG BASE N017962 001
+ VEROSCIENCE EQ 0.8MG BASE N020866 001 May 05, 2009
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
SYRUP;ORAL
BROMFED-DM
+ WOCKHARDT 2MG/5ML;10MG/5ML;30MG/5ML A088811 001 Jun 07, 1985
BUDESONIDE
CAPSULE;ORAL
BUDESONIDE
AB MYLAN 3MG A090410 001 May 16, 2011
ENTOCORT EC
AB + ASTRAZENECA 3MG N021324 001 Oct 02, 2001
POWDER, METERED;INHALATION
PULMICORT FLEXHALER
ASTRAZENECA 0.08MG/INH N021949 001 Jul 12, 2006
+ 0.16MG/INH N021949 002 Jul 12, 2006
SPRAY, METERED;NASAL
RHINOCORT
+ ASTRAZENECA 0.032MG/INH N020746 001 Oct 01, 1999
SUSPENSION;INHALATION
BUDESONIDE
AN SANDOZ 0.25MG/2ML A201966 003 Sep 27, 2013
AN 0.5MG/2ML A201966 002 Sep 27, 2013
AN 1MG/2ML A201966 001 Sep 27, 2013
AN TEVA PHARMS 0.25MG/2ML A077519 001 Nov 18, 2008
AN 0.5MG/2ML A077519 002 Nov 18, 2008
AN WATSON LABS INC 0.25MG/2ML A078404 001 Jul 31, 2012
AN 0.5MG/2ML A078404 002 Jul 31, 2012
PULMICORT RESPULES
AN ASTRAZENECA 0.25MG/2ML N020929 001 Aug 08, 2000
AN 0.5MG/2ML N020929 002 Aug 08, 2000
AN + 1MG/2ML N020929 003 Aug 08, 2000
TABLET, EXTENDED RELEASE;ORAL
UCERIS
+ SANTARUS 9MG N203634 001 Jan 14, 2013
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
AEROSOL, METERED;INHALATION
SYMBICORT
+ ASTRAZENECA 0.08MG/INH;0.0045MG/INH N021929 001 Jul 21, 2006
+ 0.16MG/INH;0.0045MG/INH N021929 002 Jul 21, 2006
BUMETANIDE
INJECTABLE;INJECTION
BUMETANIDE
AP + BEDFORD 0.25MG/ML A074441 001 Jan 27, 1995
AP HIKMA MAPLE 0.25MG/ML A079196 001 Apr 30, 2008
AP HOSPIRA 0.25MG/ML A074332 001 Oct 31, 1994
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-50( of 362)
BUMETANIDE
TABLET;ORAL
BUMETANIDE
AB IVAX SUB TEVA PHARMS 0.5MG A074225 001 Apr 24, 1995
AB 1MG A074225 002 Apr 24, 1995
AB 2MG A074225 003 Apr 24, 1995
AB SANDOZ 0.5MG A074700 001 Nov 21, 1996
AB 1MG A074700 002 Nov 21, 1996
AB + 2MG A074700 003 Nov 21, 1996
BUPIVACAINE
INJECTABLE, LIPOSOMAL;INJECTION
EXPAREL
+ PACIRA PHARMS INC 266MG/20ML (13.3MG/ML) N022496 002 Oct 28, 2011
BUPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE
AP HOSPIRA 0.25% A070583 001 Feb 17, 1987
AP 0.25% A070586 001 Mar 03, 1987
AP 0.25% A070590 001 Feb 17, 1987
AP 0.25% N018053 002
AP 0.5% A070584 001 Feb 17, 1986
AP 0.5% A070597 001 Mar 03, 1987
AP 0.5% A070609 001 Mar 03, 1987
AP 0.5% N018053 001
AP 0.75% A070585 001 Mar 03, 1987
AP 0.75% A070587 001 Mar 03, 1987
AP 0.75% N018053 003
AP SAGENT AGILA 0.25% A091503 001 Oct 18, 2011
AP 0.5% A091503 002 Oct 18, 2011
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
AP AUROBINDO PHARMA LTD 0.25% A203895 001 Nov 05, 2013
AP 0.5% A203895 002 Nov 05, 2013
AP 0.75% A203895 003 Nov 05, 2013
AP SAGENT AGILA 0.25% A091487 002 Oct 18, 2011
AP 0.5% A091487 001 Oct 18, 2011
AP 0.75% A091487 003 Oct 18, 2011
MARCAINE HYDROCHLORIDE
AP + HOSPIRA 0.25% N016964 001
AP + 0.5% N016964 006
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
AP + HOSPIRA 0.25% N016964 012
AP + 0.5% N016964 005
AP + 0.75% N016964 009
SENSORCAINE
AP FRESENIUS KABI USA 0.25% A070552 001 May 21, 1986
AP 0.25% N018304 001
AP 0.5% A070553 001 May 21, 1986
AP 0.5% N018304 002
AP 0.75% A070554 001 May 21, 1986
AP 0.75% N018304 003
INJECTABLE;SPINAL
BUPIVACAINE HYDROCHLORIDE
AP HOSPIRA 0.75% A071810 001 Dec 11, 1987
MARCAINE
AP + HOSPIRA 0.75% N018692 001 May 04, 1984
SENSORCAINE
AP FRESENIUS KABI USA 0.75% A071202 001 Apr 15, 1987
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
AP + HOSPIRA 0.5%;0.005MG/ML A071168 001 Jun 16, 1988
AP 0.5%;0.005MG/ML A071170 001 Jun 16, 1988
+ 0.25%;0.005MG/ML A071165 001 Jun 16, 1988
0.25%;0.005MG/ML A071167 001 Jun 16, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-51( of 362)
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
AP SEPTODONT 0.5%;0.0091MG/ML A077250 001 Sep 27, 2006
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE
AP + HOSPIRA 0.5%;0.0091MG/ML N022046 001 Jul 13, 1983
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
AP + HOSPIRA 0.25%;0.0091MG/ML N016964 004
AP + 0.5%;0.0091MG/ML N016964 008
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
AP + HOSPIRA 0.25%;0.0091MG/ML N016964 013
AP + 0.5%;0.0091MG/ML N016964 007
AP + 0.75%;0.0091MG/ML N016964 010
SENSORCAINE
AP FRESENIUS KABI USA 0.25%;0.0091MG/ML A070966 001 Oct 13, 1987
AP 0.25%;0.0091MG/ML A070967 001 Oct 13, 1987
AP 0.5%;0.0091MG/ML A070968 001 Oct 13, 1987
AP 0.5%;0.0091MG/ML N018304 004 Sep 02, 1983
AP 0.75%;0.0091MG/ML N018304 005 Sep 02, 1983
BUPRENORPHINE
FILM, EXTENDED RELEASE;TRANSDERMAL
BUTRANS
PURDUE PHARMA LP 5MCG/HR N021306 001 Jun 30, 2010
10MCG/HR N021306 002 Jun 30, 2010
15MCG/HR N021306 004 Jul 25, 2013
+ 20MCG/HR N021306 003 Jun 30, 2010
BUPRENORPHINE HYDROCHLORIDE
INJECTABLE;INJECTION
BUPRENEX
AP + RECKITT BENCKISER EQ 0.3MG BASE/ML N018401 001
BUPRENORPHINE HYDROCHLORIDE
AP BEDFORD EQ 0.3MG BASE/ML A076931 001 Mar 02, 2005
AP HOSPIRA EQ 0.3MG BASE/ML A074137 001 Jun 03, 1996
AP LUITPOLD EQ 0.3MG BASE/ML A078331 001 Mar 27, 2007
TABLET;SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE
AB BARR EQ 2MG BASE A090360 001 May 07, 2010
AB EQ 8MG BASE A090360 002 May 07, 2010
AB ETHYPHARM EQ 2MG BASE A090622 001 Sep 24, 2010
AB EQ 8MG BASE A090622 002 Sep 24, 2010
AB ROXANE EQ 2MG BASE A078633 001 Oct 08, 2009
AB + EQ 8MG BASE A078633 002 Oct 08, 2009
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
FILM;SUBLINGUAL
SUBOXONE
RECKITT BENCKISER EQ 2MG BASE;EQ 0.5MG BASE N022410 001 Aug 30, 2010
EQ 4MG BASE;EQ 1MG BASE N022410 003 Aug 10, 2012
EQ 8MG BASE;EQ 2MG BASE N022410 002 Aug 30, 2010
+ EQ 12MG BASE;EQ 3MG BASE N022410 004 Aug 10, 2012
TABLET;SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
AB ACTAVIS ELIZABETH EQ 2MG BASE;EQ 0.5MG BASE A091422 001 Feb 22, 2013
AB + EQ 8MG BASE;EQ 2MG BASE A091422 002 Feb 22, 2013
AB AMNEAL PHARMS EQ 8MG BASE;EQ 2MG BASE A203136 002 Feb 22, 2013
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
AB AMNEAL PHARMS EQ 2MG BASE;EQ 0.5MG BASE A203136 001 Feb 22, 2013
ZUBSOLV
OREXO AB EQ 1.4MG BASE;EQ 0.36MG BASE N204242 001 Jul 03, 2013
+ EQ 5.7MG BASE;EQ 1.4MG BASE N204242 002 Jul 03, 2013
BUPROPION HYDROBROMIDE
TABLET, EXTENDED RELEASE;ORAL
APLENZIN
VALEANT BERMUDA 174MG N022108 001 Apr 23, 2008
348MG N022108 002 Apr 23, 2008
+ 522MG N022108 003 Apr 23, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
BUPROPION HYDROCHLORIDE
TABLET;ORAL
BUPROPION HYDROCHLORIDE
AB APOTEX INC
AB
AB MYLAN
AB
AB SANDOZ
AB
WELLBUTRIN
AB GLAXOSMITHKLINE
AB +
TABLET, EXTENDED RELEASE;ORAL
BUPROPION HYDROCHLORIDE
AB1 ANCHEN PHARMS
AB1
AB1
AB1 IMPAX LABS
AB1
AB1
AB1 JUBILANT LIFE
AB1
AB1
AB1 MYLAN
AB1
AB1
AB1 SANDOZ
AB1
AB1
AB1 SUN PHARMA GLOBAL
AB1
AB1
AB1 WATSON LABS FLORIDA
AB1
AB1
AB1 WATSON LABS INC
AB1
AB1
AB1 WOCKHARDT LTD
AB1
AB1
WELLBUTRIN SR
AB1 GLAXOSMITHKLINE
AB1
AB1 +
BUPROPION HYDROCHLORIDE
AB2 ACTAVIS
AB2 ANCHEN PHARMS
AB2 IMPAX LABS
AB2 JUBILANT LIFE
AB2 MYLAN
AB2 WATSON LABS FLORIDA
ZYBAN
AB2 + GLAXOSMITHKLINE
BUPROPION HYDROCHLORIDE
AB3 ANCHEN PHARMS
AB3
AB3 IMPAX LABS
AB3 MYLAN
AB3
AB3 WATSON LABS
AB3 WATSON LABS INC
AB3
AB3 WOCKHARDT LTD
WELLBUTRIN XL
AB3 VALEANT INTL
AB3 +
BUPROPION HYDROCHLORIDE
BX WATSON LABS
FORFIVO XL
EDGEMONT PHARMS LLC +
75MG
100MG
75MG
100MG
75MG
100MG
75MG
100MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
150MG
150MG
150MG
150MG
150MG
150MG
150MG
150MG
300MG
150MG
150MG
300MG
150MG
150MG
300MG
150MG
150MG
300MG
300MG
450MG
3-52( of 362)
A076143 001 Jan 17, 2006
A076143 002 Jan 17, 2006
A075491 001 Apr 17, 2000
A075491 002 Apr 17, 2000
A075584 001 Feb 07, 2000
A075584 002 Feb 07, 2000
N018644 002 Dec 30, 1985
N018644 003 Dec 30, 1985
A091459 001 Jun 09, 2011
A091459 002 Jun 09, 2011
A091459 003 Jun 09, 2011
A075913 001 Jan 28, 2004
A075913 002 Mar 22, 2004
A076711 001 Dec 03, 2004
A202774 001 Oct 11, 2013
A202774 002 Oct 11, 2013
A202774 003 Oct 11, 2013
A090325 001 Apr 08, 2010
A090325 002 Apr 08, 2010
A090325 003 Apr 08, 2010
A075932 001 Nov 25, 2003
A075932 002 Mar 22, 2004
A075932 003 Jun 22, 2005
A078866 001 Apr 06, 2010
A078866 002 Apr 06, 2010
A078866 003 Apr 06, 2010
A079095 001 Mar 24, 2009
A079095 002 Mar 24, 2009
A079095 003 Mar 24, 2009
A077455 001 Jul 19, 2010
A077455 002 Mar 12, 2008
A077455 003 Jul 19, 2010
A201331 001 Aug 30, 2012
A201331 002 Aug 30, 2012
A201331 003 Aug 30, 2012
N020358 002 Oct 04, 1996
N020358 003 Oct 04, 1996
N020358 004 Jun 14, 2002
A077475 001 Mar 12, 2008
A091520 001 Jun 09, 2011
A075914 001 May 27, 2004
A202775 001 Oct 11, 2013
A090941 001 May 03, 2010
A079094 001 Mar 24, 2009
N020711 003 May 14, 1997
A077284 001 Dec 14, 2006
A077284 002 Dec 14, 2006
A077415 001 Nov 26, 2008
A090942 001 Jul 14, 2010
A090942 002 Jul 14, 2010
A077715 001 Nov 26, 2008
A077285 001 Nov 26, 2008
A077285 002 Aug 15, 2008
A202189 001 Nov 21, 2012
N021515 001 Aug 28, 2003
N021515 002 Aug 28, 2003
A077715 002 Jun 13, 2007
N022497 001 Nov 10, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-53( of 362)
BUSPIRONE HYDROCHLORIDE
TABLET;ORAL
BUSPIRONE HYDROCHLORIDE
AB DR REDDYS LABS LTD 5MG A078246 001 Feb 27, 2009
AB 10MG A078246 002 Feb 27, 2009
AB 15MG A078246 003 Feb 27, 2009
AB 30MG A078246 004 Feb 27, 2009
AB MYLAN 5MG A075272 001 Mar 01, 2002
AB 5MG A075467 001 Feb 28, 2002
AB 7.5MG A075467 002 Mar 28, 2001
AB 10MG A075272 002 Mar 01, 2002
AB 10MG A075467 003 Feb 28, 2002
AB 15MG A075272 003 Mar 28, 2001
AB 15MG A075467 004 Feb 28, 2002
AB 30MG A076008 001 Jun 28, 2001
AB PROSAM LABS 30MG A078302 001 Dec 17, 2007
AB TEVA 5MG A075022 001 Feb 28, 2002
AB 10MG A075022 002 Feb 28, 2002
AB + 15MG A075022 003 Feb 28, 2002
AB 30MG A075022 004 Mar 25, 2004
AB WATSON LABS 5MG A074253 001 Mar 28, 2001
AB 10MG A074253 002 Mar 28, 2001
AB 15MG A074253 003 Mar 13, 2002
BUSULFAN
INJECTABLE;INJECTION
BUSULFEX
+ OTSUKA PHARM 6MG/ML N020954 001 Feb 04, 1999
TABLET;ORAL
MYLERAN
+ ASPEN GLOBAL 2MG N009386 001
BUTABARBITAL SODIUM
ELIXIR;ORAL
BUTISOL SODIUM
+ MEDA PHARMS 30MG/5ML A085380 001
TABLET;ORAL
BUTISOL SODIUM
+ MEDA PHARMS 30MG N000793 004
+ 50MG N000793 003
BUTENAFINE HYDROCHLORIDE
CREAM;TOPICAL
MENTAX
+ MYLAN 1% N020524 001 Oct 18, 1996
MENTAX-TC
+ MYLAN 1% N021408 001 Oct 17, 2002
BUTOCONAZOLE NITRATE
CREAM;VAGINAL
BUTOCONAZOLE NITRATE
+ PERRIGO ISRAEL 2% A200923 001 May 18, 2012
BUTORPHANOL TARTRATE
INJECTABLE;INJECTION
BUTORPHANOL TARTRATE
AP BEDFORD 2MG/ML A075046 001 Aug 12, 1998
AP HIKMA FARMACEUTICA 1MG/ML A078400 001 May 01, 2009
AP 2MG/ML A078247 001 Apr 29, 2009
AP 2MG/ML A078400 002 May 01, 2009
BUTORPHANOL TARTRATE PRESERVATIVE FREE
AP BEDFORD 1MG/ML A075045 001 Aug 12, 1998
AP 2MG/ML A075045 002 Aug 12, 1998
AP HOSPIRA 1MG/ML A074626 001 Jan 23, 1997
AP 2MG/ML A074626 002 Jan 23, 1997
SPRAY, METERED;NASAL
BUTORPHANOL TARTRATE
AB + MYLAN 1MG/SPRAY A075759 001 Aug 08, 2001
AB NOVEX 1MG/SPRAY A075499 001 Dec 04, 2002
AB ROXANE 1MG/SPRAY A075824 001 Mar 12, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-54( of 362)
CABAZITAXEL
SOLUTION;IV (INFUSION)
JEVTANA KIT
+ SANOFI AVENTIS US 60MG/1.5ML (40MG/ML) N201023 001 Jun 17, 2010
CABERGOLINE
TABLET;ORAL
CABERGOLINE
AB APOTEX CORP 0.5MG A201503 001 Mar 08, 2013
AB IMPAX LABS INC 0.5MG A077843 001 Jul 03, 2007
AB IVAX SUB TEVA PHARMS 0.5MG A077750 001 Mar 07, 2007
AB MYLAN PHARMS INC 0.5MG A202947 001 Dec 02, 2013
AB + PAR PHARM 0.5MG A076310 001 Dec 29, 2005
AB WATSON LABS 0.5MG A078035 001 Apr 21, 2008
CABOZANTINIB S-MALATE
CAPSULE;ORAL
COMETRIQ
EXELIXIS EQ 20MG BASE N203756 001 Nov 29, 2012
+ EQ 80MG BASE N203756 002 Nov 29, 2012
CAFFEINE CITRATE
SOLUTION;INTRAVENOUS
CAFCIT
AP + BEDFORD LABS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N020793 001 Sep 21, 1999
CAFFEINE CITRATE
AP FRESENIUS KABI USA EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077997 001 Jul 20, 2007
AP LUITPOLD EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077906 001 May 15, 2007
AP PADDOCK LLC EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077233 001 Sep 21, 2006
AP SAGENT PHARMS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090827 001 Aug 29, 2012
AP SUN PHARMA GLOBAL EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090077 001 Sep 30, 2009
SOLUTION;ORAL
CAFCIT
AA + BEDFORD LABS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N020793 002 Apr 12, 2000
CAFFEINE CITRATE
AA FRESENIUS KABI USA EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A078002 001 Jan 31, 2008
AA LUITPOLD EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090064 001 Nov 20, 2009
AA PADDOCK LLC EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077304 001 Sep 21, 2006
AA SAGENT PHARMS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A091102 001 Aug 29, 2012
AA SUN PHARMA GLOBAL EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090357 001 Sep 30, 2009
CAFFEINE; ERGOTAMINE TARTRATE
SUPPOSITORY;RECTAL
MIGERGOT
+ CREALTA PHARMS LLC 100MG;2MG A086557 001 Oct 04, 1983
TABLET;ORAL
CAFERGOT
AA + SANDOZ 100MG;1MG A084294 001
ERGOTAMINE TARTRATE AND CAFFEINE
AA MIKART 100MG;1MG A040590 001 Sep 16, 2005
AA WEST WARD 100MG;1MG A040510 001 Sep 17, 2004
CALCIPOTRIENE
AEROSOL, FOAM;TOPICAL
SORILUX
+ STIEFEL LABS INC 0.005% N022563 001 Oct 06, 2010
CREAM;TOPICAL
CALCIPOTRIENE
AB TOLMAR 0.005% A200935 001 May 30, 2012
DOVONEX
AB + LEO PHARMA AS 0.005% N020554 001 Jul 22, 1996
OINTMENT;TOPICAL
CALCIPOTRIENE
+ GLENMARK GENERICS 0.005% A090633 001 Mar 24, 2010
SOLUTION;TOPICAL
CALCIPOTRIENE
AT FOUGERA PHARMS 0.005% A078305 001 May 06, 2008
AT G AND W LABS INC 0.005% A078468 001 Mar 24, 2011
AT HI TECH PHARMA 0.005% A077579 001 Nov 19, 2009
AT TOLMAR 0.005% A077029 001 Nov 20, 2009
DOVONEX
AT + LEO PHARM 0.005% N020611 001 Mar 03, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
CALCITONIN SALMON
INJECTABLE;INJECTION
MIACALCIN
+ NOVARTIS
SPRAY, METERED;NASAL
CALCITONIN-SALMON
AB APOTEX INC
AB PAR PHARM
MIACALCIN
AB + NOVARTIS
CALCITONIN SALMON RECOMBINANT
SPRAY, METERED;NASAL
FORTICAL
+ UPSHER SMITH
CALCITRIOL
CAPSULE;ORAL
CALCITRIOL
AB BANNER PHARMACAPS
AB
AB ROXANE
AB TEVA
AB
ROCALTROL
AB VALIDUS PHARMS
AB +
INJECTABLE;INJECTION
CALCIJEX
AP + ABBVIE
AP +
CALCITRIOL
AP AKORN
AP
AP FRESENIUS KABI USA
AP
AP FRESENIUS MEDCL
AP
AP LUITPOLD
AP
AP ROCKWELL MEDCL
AP SAGENT PHARMS
AP TEVA PARENTERAL
OINTMENT;TOPICAL
VECTICAL
+ GALDERMA LABS LP
SOLUTION;ORAL
CALCITRIOL
AA ROXANE
ROCALTROL
AA + VALIDUS PHARMS
CALCIUM ACETATE
CAPSULE;ORAL
CALCIUM ACETATE
AB INVAGEN PHARMS
AB PADDOCK LLC
AB ROXANE
PHOSLO GELCAPS
AB + FRESENIUS MEDCL
SOLUTION;ORAL
PHOSLYRA
+ FRESENIUS MEDCL
TABLET;ORAL
CALCIUM ACETATE
AB INVAGEN PHARMS
AB PADDOCK LLC
ELIPHOS
AB + CYPRESS PHARM
200 IU/ML
200 IU/SPRAY
200 IU/SPRAY
200 IU/SPRAY
200 IU/SPRAY
0.25MCG
0.5MCG
0.25MCG
0.25MCG
0.5MCG
0.25MCG
0.5MCG
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.001MG/ML
0.002MG/ML
3MCG/GM
1MCG/ML
1MCG/ML
EQ 169MG CALCIUM
EQ 169MG CALCIUM
EQ 169MG CALCIUM
EQ 169MG CALCIUM
EQ 169MG CALCIUM/5ML
EQ 169MG CALCIUM
EQ 169MG CALCIUM
EQ 169MG CALCIUM
3-55( of 362)
N017808 002 Mar 29, 1991
A076396 001 Nov 17, 2008
A076979 001 Jun 08, 2009
N020313 002 Aug 17, 1995
N021406 001 Aug 12, 2005
A091174 001 May 24, 2013
A091174 002 May 24, 2013
A076917 001 Mar 27, 2006
A075765 001 Oct 12, 2001
A075765 002 Oct 12, 2001
N018044 001
N018044 002
N018874 001 Sep 25, 1986
N018874 002 Sep 25, 1986
A078066 001 Jan 29, 2008
A078066 002 Jan 29, 2008
A075836 001 Dec 31, 2002
A075836 002 Dec 31, 2002
A075766 001 Feb 20, 2003
A075766 002 Feb 20, 2003
A075746 001 Sep 26, 2003
A075746 002 Sep 26, 2003
A076206 001 Sep 17, 2003
A077102 001 Feb 08, 2006
A075823 002 Mar 31, 2003
N022087 001 Jan 23, 2009
A076242 001 Jul 18, 2003
N021068 001 Nov 20, 1998
A203135 001 Feb 07, 2013
A091312 001 Jun 01, 2012
A077728 001 Feb 26, 2008
N021160 003 Apr 02, 2001
N022581 001 Apr 18, 2011
A202420 001 Feb 05, 2013
A091561 001 Apr 13, 2011
A078502 001 Nov 25, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-56( of 362)
CALCIUM CHLORIDE
INJECTABLE;INJECTION
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER
+ HOSPIRA 100MG/ML N021117 001 Jan 28, 2000
CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM
BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
SOLUTION;IRRIGATION
BSS PLUS
AT + ALCON 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M N018469 001
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L
ENDOSOL EXTRA
AT + AKORN 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M N020079 001 Nov 27, 1991
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM
BICARBONATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0
5GM/1000ML;0.157GM/1000ML;2.21GM/1000ML
;7.07GM/1000ML
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0
5GM/1000ML;0.314GM/1000ML;2.21GM/1000ML
;7.07GM/1000ML
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
3.05GM/1000ML;0.314GM/1000ML;2.21GM/100
0ML;7.07GM/1000ML
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;
6.46GM/1000ML
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.0
3GM/1000ML;0.157GM/1000ML;3.09GM/1000ML
;6.46GM/1000ML
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;
2.03GM/1000ML;0.157GM/1000ML;3.09GM/100
0ML;6.46GM/1000ML
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.4
4GM/1000ML;0.314GM/1000ML;3.09GM/1000ML
;6.46GM/1000ML
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
3.05GM/1000ML;0.314GM/1000ML;3.09GM/100
0ML;6.46GM/1000ML
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44
GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46
GM/1000ML
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2
.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6
.46GM/1000ML
N021703 010 Oct 10, 2008
N021703 011 Oct 10, 2008
N021703 013 Oct 10, 2008
N021703 006 Oct 25, 2006
N021703 002 Oct 25, 2006
N021703 003 Oct 25, 2006
N021703 015 Oct 10, 2008
N021703 004 Oct 25, 2006
N021703 014 Oct 10, 2008
N021703 001 Oct 25, 2006
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM
BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
SOLUTION;IRRIGATION
NAVSTEL
+ ALCON PHARMS LTD 0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/M N022193 001 Jul 24, 2008
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE
INJECTABLE;INJECTION
ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER
+ B BRAUN 37MG/100ML;5GM/100ML;31MG/100ML;120MG/1 N019864 001 Jun 10, 1993
00ML;330MG/100ML;88MG/100ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-57( of 362)
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 37MG/100ML;5GM/100ML;30MG/100ML;119MG/1 N017390 001
00ML;161MG/100ML;94MG/100ML;138MG/100ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
SOLUTION;INTRAPERITONEAL
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER
+ B BRAUN 510MG/100ML;30GM/100ML;200MG/100ML;9.2G
M/100ML;9.6GM/100ML
+ 510MG/100ML;30GM/100ML;200MG/100ML;9.4G
M/100ML;11GM/100ML
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER
+ B BRAUN 510MG/100ML;50GM/100ML;200MG/100ML;9.2G
M/100ML;9.6GM/100ML
+ 510MG/100ML;50GM/100ML;200MG/100ML;9.4G
M/100ML;11GM/100ML
N018807 001 Aug 26, 1983
N018807 003 Aug 26, 1983
N018807 002 Aug 26, 1983
N018807 004 Aug 26, 1983
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
SOLUTION;INTRAPERITONEAL
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5
67MG/100ML;392MG/100ML
AT 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5
67MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020171 001 Aug 19, 1992
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N018379 003
67MG/100ML;392MG/100ML
AT 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N018883 002 Nov 30, 1984
67MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N018883 005 Nov 30, 1984
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5
67MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;
567MG/100ML;392MG/100ML
AT 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;
567MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;
538MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;
538MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;
538MG/100ML;448MG/100ML
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5
67MG/100ML;392MG/100ML
DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5
67MG/100ML;392MG/100ML
N018379 002
N018883 001 Nov 30, 1984
N018883 004 Nov 30, 1984
N020171 002 Aug 19, 1992
N018379 007 Jun 24, 1988
N018379 001
N018883 003 Nov 30, 1984
N018883 006 Nov 30, 1984
N020171 003 Aug 19, 1992
N018379 004 Jul 07, 1982
N018379 005 Jul 07, 1982
N018379 008 Jun 24, 1988
N018379 006 Jul 07, 1982
N017512 001
N017512 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-58( of 362)
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
SOLUTION;INTRAPERITONEAL
DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N017512 002
567MG/100ML;392MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020183 001 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N017512 007 Jul 09, 1984
67MG/100ML;392MG/100ML
DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N017512 008 Jul 09, 1984
67MG/100ML;392MG/100ML
DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5 N017512 010 Nov 18, 1985
67MG/100ML;392MG/100ML
DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N017512 009 Jul 09, 1984
567MG/100ML;392MG/100ML
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N017512 004
38MG/100ML;448MG/100ML
AT 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020163 001 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N017512 005
38MG/100ML;448MG/100ML
AT 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020163 002 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5 N017512 011 Nov 18, 1985
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N017512 006
538MG/100ML;448MG/100ML
AT 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N020163 003 Dec 04, 1992
538MG/100ML;448MG/100ML
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/ N018460 007 Jan 29, 1986
100ML;450MG/100ML
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/ N018460 005 Nov 02, 1983
100ML;450MG/100ML
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;4.25GM/100ML;5MG/100ML;530MG N018460 009 Jan 29, 1986
/100ML;450MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020183 002 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;5 N020183 003 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML; N020183 004 Dec 04, 1992
538MG/100ML;448MG/100ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM
CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE;INTRATHECAL
ELLIOTTS B SOLUTION
+ LUKARE MEDICAL LLC 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9 N020577 001 Sep 27, 1996
MG/ML;7.3MG/ML;0.2MG/ML
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER
+ B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;380MG/1 N018258 001
00ML;600MG/100ML
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER
AP HOSPIRA 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N018254 001
00ML
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N020000 001 Apr 17, 1992
00ML
AP BAXTER HLTHCARE 33MG/100ML;5GM/100ML;30MG/100ML; N016695 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-59( of 362)
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
860MG/100ML
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP HOSPIRA 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N017608 001
00ML;310MG/100ML
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N019634 003 Feb 24, 1988
00ML;310MG/100ML
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N016679 001
00ML;310MG/100ML
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 006 Apr 05, 1985
100ML;310MG/100ML
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 004 Apr 05, 1985
100ML;310MG/100ML
AP 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 005 Apr 05, 1985
100ML;310MG/100ML
AP HOSPIRA 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019685 002 Oct 17, 1988
100ML;310MG/100ML
AP 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 008 Oct 17, 1988
100ML;310MG/100ML
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 007 Apr 05, 1985
100ML;310MG/100ML
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 008 Apr 05, 1985
100ML;310MG/100ML
AP HOSPIRA 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 004 Oct 17, 1988
100ML;310MG/100ML
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN 10MG/100ML;2.5GM/100ML;15MG/100ML;300MG N019634 001 Feb 24, 1988
/100ML;160MG/100ML
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
BAXTER HLTHCARE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/ N019367 002 Apr 05, 1985
100ML;310MG/100ML
20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 003 Apr 05, 1985
100ML;310MG/100ML
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
BAXTER HLTHCARE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/ N019367 001 Apr 05, 1985
100ML;310MG/100ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
TPN ELECTROLYTES IN PLASTIC CONTAINER
+ HOSPIRA 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML; N018895 001 Jul 20, 1984
16.1MG/ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
CITRATE
INJECTABLE;INJECTION
ISOLYTE E IN PLASTIC CONTAINER
+ B BRAUN 35MG/100ML;30MG/100ML;74MG/100ML;640MG/ N019718 001 Sep 29, 1989
100ML;500MG/100ML;74MG/100ML
SOLUTION;IRRIGATION
BALANCED SALT
AT AKORN 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 A075503 001 Sep 27, 2006
.4MG/ML;1.7MG/ML
AT B BRAUN 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 A091387 001 Feb 03, 2010
.4MG/ML;1.7MG/ML
BSS
AT + ALCON 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 N020742 001 Dec 10, 1997
.4MG/ML;1.7MG/ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
LACTATE
INJECTABLE;INJECTION
PLASMA-LYTE R IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 36.8MG/100ML;30.5MG/100ML;74.6MG/100ML; N017438 001
640MG/100ML;496MG/100ML;89.6MG/100ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-60( of 362)
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
SOLUTION;PERFUSION, CARDIAC
CARDIOPLEGIC IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 17.6MG/100ML;325.3MG/100ML;119.3MG/100M A075323 001 Apr 21, 2000
L;643MG/100ML
PLEGISOL IN PLASTIC CONTAINER
AT + HOSPIRA 17.6MG/100ML;325.3MG/100ML;119.3MG/100M N018608 001 Feb 26, 1982
L;643MG/100ML
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML N020002 001 Apr 17, 1992
AP BAXTER HLTHCARE 33MG/100ML;30MG/100ML;860MG/100ML N016693 001
AP HOSPIRA 33MG/100ML;30MG/100ML;860MG/100ML N018251 001
SOLUTION;IRRIGATION
RINGER'S IN PLASTIC CONTAINER
AT B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML N018156 001
AT BAXTER HLTHCARE 33MG/100ML;30MG/100ML;860MG/100ML N018495 001 Feb 19, 1982
AT HOSPIRA 33MG/100ML;30MG/100ML;860MG/100ML N017635 001
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
LACTATED RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019632 001 Feb 29, 1988
/100ML
AP BAXTER HLTHCARE 20MG/100ML;30MG/100ML;600MG/100ML;310MG N016682 001
/100ML
AP HOSPIRA 20MG/100ML;30MG/100ML;600MG/100ML;310MG N017641 001
/100ML
SOLUTION;IRRIGATION
LACTATED RINGER'S IN PLASTIC CONTAINER
AT + B BRAUN 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018681 001 Dec 27, 1982
/100ML
AT BAXTER HLTHCARE 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018494 001 Feb 19, 1982
/100ML
AT + 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018921 001 Apr 03, 1984
/100ML
AT + 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019933 001 Aug 29, 1989
/100ML
AT + HOSPIRA 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019416 001 Jan 17, 1986
/100ML
CALFACTANT
SUSPENSION;INTRATRACHEAL
INFASURF PRESERVATIVE FREE
+ ONY 35MG/ML N020521 001 Jul 01, 1998
CANAGLIFLOZIN
TABLET;ORAL
INVOKANA
JANSSEN PHARMS 100MG N204042 001 Mar 29, 2013
+ 300MG N204042 002 Mar 29, 2013
CANDESARTAN CILEXETIL
TABLET;ORAL
ATACAND
AB ASTRAZENECA 4MG N020838 001 Jun 04, 1998
AB 8MG N020838 002 Jun 04, 1998
AB 16MG N020838 003 Jun 04, 1998
AB + 32MG N020838 004 Jun 04, 1998
CANDESARTAN CILEXETIL
AB APOTEX INC 4MG A202079 001 Jan 10, 2014
AB 8MG A202079 002 Jan 10, 2014
AB 16MG A202079 003 Jan 10, 2014
AB 32MG A202079 004 Jan 10, 2014
AB SANDOZ 4MG A078702 001 May 03, 2013
AB 8MG A078702 002 May 03, 2013
AB 16MG A078702 003 May 03, 2013
AB 32MG A078702 004 May 03, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-61( of 362)
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
ATACAND HCT
AB ASTRAZENECA 16MG;12.5MG N021093 001 Sep 05, 2000
AB 32MG;12.5MG N021093 002 Sep 05, 2000
AB + 32MG;25MG N021093 003 May 16, 2008
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
AB APOTEX INC 16MG;12.5MG A202884 001 Dec 04, 2012
AB 32MG;12.5MG A202884 002 Dec 04, 2012
AB 32MG;25MG A202884 003 Jun 03, 2013
AB DR REDDYS LABS LTD 16MG;12.5MG A202965 001 Jun 03, 2013
AB 32MG;12.5MG A202965 002 Jun 03, 2013
AB 32MG;25MG A202965 003 Jun 03, 2013
AB MYLAN LABS 16MG;12.5MG A090704 001 Dec 04, 2012
AB 32MG;12.5MG A090704 002 Dec 04, 2012
AB 32MG;25MG A090704 003 Dec 04, 2012
CAPECITABINE
TABLET;ORAL
CAPECITABINE
AB TEVA PHARMS USA 150MG A091649 001 Sep 16, 2013
AB 500MG A091649 002 Sep 16, 2013
XELODA
AB HOFFMANN LA ROCHE 150MG N020896 001 Apr 30, 1998
AB + 500MG N020896 002 Apr 30, 1998
CAPREOMYCIN SULFATE
INJECTABLE;INJECTION
CAPASTAT SULFATE
+ AKORN EQ 1GM BASE/VIAL N050095 001
CAPSAICIN
PATCH;TOPICAL
QUTENZA
+ ACORDA 8% N022395 001 Nov 16, 2009
CAPTOPRIL
TABLET;ORAL
CAPOTEN
AB PAR PHARM 12.5MG N018343 005 Jan 17, 1985
AB 25MG N018343 002
AB 50MG N018343 001
AB + 100MG N018343 003
CAPTOPRIL
AB APOTEX 12.5MG A074737 001 Oct 28, 1998
AB 25MG A074737 002 Oct 28, 1998
AB 50MG A074737 003 Oct 28, 1998
AB 100MG A074737 004 Oct 28, 1998
AB MYLAN 12.5MG A074434 001 Feb 13, 1996
AB 25MG A074434 002 Feb 13, 1996
AB 50MG A074434 003 Feb 13, 1996
AB 100MG A074434 004 Feb 13, 1996
AB SANDOZ 12.5MG A074363 001 Nov 09, 1995
AB 25MG A074363 002 Nov 09, 1995
AB 50MG A074363 003 Nov 09, 1995
AB 100MG A074363 004 Nov 09, 1995
AB STASON 12.5MG A074677 004 May 30, 1997
AB 25MG A074677 002 May 30, 1997
AB 50MG A074677 001 May 30, 1997
AB 100MG A074677 003 May 30, 1997
AB TEVA 12.5MG A074322 001 Feb 13, 1996
AB 25MG A074322 002 Feb 13, 1996
AB 50MG A074322 003 Feb 13, 1996
AB 100MG A074322 004 Feb 13, 1996
AB WATSON LABS 12.5MG A074386 001 May 23, 1996
AB 12.5MG A074451 001 Feb 13, 1996
AB 25MG A074386 002 May 23, 1996
AB 25MG A074451 002 Feb 13, 1996
AB 50MG A074386 003 May 23, 1996
AB 50MG A074451 003 Feb 13, 1996
AB 100MG A074386 004 May 23, 1996
AB 100MG A074451 004 Feb 13, 1996
AB WEST WARD 12.5MG A074505 001 Feb 13, 1996
AB 25MG A074505 002 Feb 13, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-62( of 362)
CAPTOPRIL
TABLET;ORAL
CAPTOPRIL
AB 50MG A074505 003 Feb 13, 1996
AB 100MG A074505 004 Feb 13, 1996
AB WOCKHARDT 12.5MG A074532 001 Mar 28, 1997
AB 25MG A074532 002 Mar 28, 1997
AB 50MG A074532 003 Mar 28, 1997
AB 100MG A074532 004 Mar 28, 1997
CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
CAPOZIDE 25/15
AB APOTHECON 25MG;15MG N018709 001 Oct 12, 1984
CAPOZIDE 25/25
AB + APOTHECON 25MG;25MG N018709 002 Oct 12, 1984
CAPOZIDE 50/15
AB + APOTHECON 50MG;15MG N018709 004 Oct 12, 1984
CAPOZIDE 50/25
AB APOTHECON 50MG;25MG N018709 003 Oct 12, 1984
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
AB MYLAN 25MG;15MG A074896 001 Dec 29, 1997
AB 25MG;25MG A074896 002 Dec 29, 1997
AB 50MG;15MG A074896 004 Dec 29, 1997
AB 50MG;25MG A074896 003 Dec 29, 1997
AB TEVA 25MG;15MG A074827 001 Dec 29, 1997
AB 25MG;25MG A074827 002 Dec 29, 1997
AB 50MG;15MG A074827 004 Dec 29, 1997
AB 50MG;25MG A074827 003 Dec 29, 1997
CARBACHOL
SOLUTION;INTRAOCULAR
MIOSTAT
+ ALCON 0.01% N016968 001
CARBAMAZEPINE
CAPSULE, EXTENDED RELEASE;ORAL
CARBAMAZEPINE
AB APOTEX INC 100MG A078986 001 Nov 25, 2011
AB 200MG A078986 002 Nov 25, 2011
AB 300MG A078986 003 Nov 25, 2011
AB NOSTRUM 100MG A076697 001 May 20, 2011
AB 200MG A076697 002 May 20, 2011
AB 300MG A076697 003 May 20, 2011
AB TARO 100MG A201106 001 Jun 21, 2013
AB 200MG A201106 002 Jun 21, 2013
AB 300MG A201106 003 Jun 21, 2013
AB TEVA PHARMS 100MG A078592 001 Sep 20, 2012
AB 200MG A078592 002 Sep 20, 2012
AB 300MG A078592 003 Sep 20, 2012
CARBATROL
AB SHIRE 100MG N020712 003 Sep 30, 1997
AB 200MG N020712 001 Sep 30, 1997
AB + 300MG N020712 002 Sep 30, 1997
EQUETRO
VALIDUS PHARMS INC 100MG N021710 001 Dec 10, 2004
200MG N021710 002 Dec 10, 2004
+ 300MG N021710 003 Dec 10, 2004
SUSPENSION;ORAL
CARBAMAZEPINE
AB WOCKHARDT 100MG/5ML A075714 001 Jun 05, 2002
TEGRETOL
AB + NOVARTIS 100MG/5ML N018927 001 Dec 18, 1987
TERIL
AB TARO 100MG/5ML A076729 001 Sep 20, 2004
TABLET;ORAL
CARBAMAZEPINE
AB APOTEX INC 200MG A075948 001 Feb 27, 2002
AB TARO 200MG A074649 001 Oct 03, 1996
AB TORRENT PHARMS 200MG A077272 002 Dec 07, 2005
EPITOL
AB TEVA 200MG A070541 001 Sep 17, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
CARBAMAZEPINE
TABLET;ORAL
TEGRETOL
AB + NOVARTIS
CARBAMAZEPINE
TORRENT PHARMS
TABLET, CHEWABLE;ORAL
CARBAMAZEPINE
AB TARO PHARM INDS
AB TORRENT PHARMS
EPITOL
AB TEVA
TEGRETOL
AB + NOVARTIS
CARBAMAZEPINE
+ TARO PHARM INDS
TABLET, EXTENDED RELEASE;ORAL
CARBAMAZEPINE
AB TARO 100MG
AB 200MG
AB 400MG
TEGRETOL-XR
AB NOVARTIS 100MG
AB 200MG
AB + 400MG
CARBIDOPA
TABLET;ORAL
LODOSYN
+ ATON 25MG
CARBIDOPA; ENTACAPONE; LEVODOPA
TABLET;ORAL
CARBIDOPA, LEVODOPA AND ENTACAPONE
AB SUN PHARMA GLOBAL
AB
AB WOCKHARDT LTD
AB
AB
AB
AB
AB
STALEVO 100
AB ORION PHARMA
STALEVO 125
AB ORION PHARMA
STALEVO 150
AB ORION PHARMA
STALEVO 200
AB + ORION PHARMA
STALEVO 50
AB + ORION PHARMA
STALEVO 75
AB ORION PHARMA
CARBIDOPA; LEVODOPA
TABLET;ORAL
CARBIDOPA AND LEVODOPA
AB ACTAVIS ELIZABETH
AB
AB
AB APOTEX INC
AB
AB
AB MYLAN
AB
AB
AB SUN PHARM INDS
AB
AB
AB TEVA
AB
200MG
100MG
300MG
400MG
100MG
100MG
100MG
100MG
200MG
25MG;200MG;100MG
37.5MG;200MG;150MG
12.5MG;200MG;50MG
18.75MG;200MG;75MG
25MG;200MG;100MG
31.25MG;200MG;125MG
37.5MG;200MG;150MG
50MG;200MG;200MG
25MG;200MG;100MG
31.25MG;200MG;125MG
37.5MG;200MG;150MG
50MG;200MG;200MG
12.5MG;200MG;50MG
18.75MG;200MG;75MG
10MG;100MG
25MG;100MG
25MG;250MG
10MG;100MG
25MG;100MG
25MG;250MG
10MG;100MG
25MG;100MG
25MG;250MG
10MG;100MG
25MG;100MG
25MG;250MG
10MG;100MG
25MG;100MG
3-63( of 362)
N016608 001
A077272 001 Dec 07, 2005
A077272 003 Dec 07, 2005
A077272 004 Dec 07, 2005
A075687 001 Oct 24, 2000
A075712 001 Jul 05, 2001
A073524 001 Jul 29, 1992
N018281 001
A075687 002 Jul 29, 2002
A078115 001 Mar 31, 2009
A078115 002 Mar 31, 2009
A078115 003 Mar 31, 2009
N020234 001 Mar 25, 1996
N020234 002 Mar 25, 1996
N020234 003 Mar 25, 1996
N017830 001
A079085 001 May 10, 2012
A079085 002 May 10, 2012
A090786 001 Nov 20, 2012
A090833 001 Nov 20, 2012
A090833 002 Nov 20, 2012
A090833 003 Nov 20, 2012
A090833 004 Nov 20, 2012
A090833 005 Nov 20, 2012
N021485 002 Jun 11, 2003
N021485 006 Aug 29, 2008
N021485 003 Jun 11, 2003
N021485 004 Aug 02, 2007
N021485 001 Jun 11, 2003
N021485 005 Aug 29, 2008
A074260 001 Sep 03, 1993
A074260 002 Sep 03, 1993
A074260 003 Sep 03, 1993
A077120 001 Jun 02, 2008
A077120 002 Jun 02, 2008
A077120 003 Jun 02, 2008
A090324 001 Sep 28, 2009
A090324 002 Sep 28, 2009
A090324 003 Sep 28, 2009
A078536 001 Oct 28, 2008
A078536 002 Oct 28, 2008
A078536 003 Oct 28, 2008
A073618 001 Aug 28, 1992
A073589 001 Aug 28, 1992
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-64( of 362)
CARBIDOPA; LEVODOPA
TABLET;ORAL
CARBIDOPA AND LEVODOPA
AB 25MG;250MG A073607 001 Aug 28, 1992
SINEMET
AB MERCK SHARP DOHME 10MG;100MG N017555 001
AB 25MG;100MG N017555 003
AB + 25MG;250MG N017555 002
TABLET, EXTENDED RELEASE;ORAL
CARBIDOPA AND LEVODOPA
AB ACCORD HLTHCARE 25MG;100MG A202323 001 Feb 08, 2013
AB 50MG;200MG A202323 002 Feb 08, 2013
AB APOTEX 25MG;100MG A076212 001 Jun 16, 2004
AB 50MG;200MG A076212 002 Jun 16, 2004
AB IMPAX LABS 25MG;100MG A076521 001 May 14, 2004
AB 50MG;200MG A076521 002 May 14, 2004
AB MYLAN 25MG;100MG A075091 002 Apr 21, 2000
AB 50MG;200MG A075091 001 Sep 30, 1999
AB SUN PHARM INDS 25MG;100MG A077828 001 Aug 23, 2007
AB 50MG;200MG A077828 002 Aug 23, 2007
SINEMET CR
AB MERCK SHARP DOHME 25MG;100MG N019856 002 Dec 24, 1992
AB + 50MG;200MG N019856 001 May 30, 1991
TABLET, ORALLY DISINTEGRATING;ORAL
CARBIDOPA AND LEVODOPA
AB IMPAX LABS 10MG;100MG A090631 001 Jun 08, 2010
AB 25MG;100MG A090631 002 Jun 08, 2010
AB 25MG;250MG A090631 003 Jun 08, 2010
AB MYLAN 10MG;100MG A078893 001 Sep 18, 2008
AB 25MG;100MG A078893 002 Sep 18, 2008
AB 25MG;250MG A078893 003 Sep 18, 2008
AB SUN PHARM INDS 10MG;100MG A078690 001 Jul 31, 2009
AB 25MG;100MG A078690 002 Jul 31, 2009
AB 25MG;250MG A078690 003 Jul 31, 2009
PARCOPA
AB UCB INC 10MG;100MG A076699 001 Aug 27, 2004
AB 25MG;100MG A076699 002 Aug 27, 2004
AB + 25MG;250MG A076699 003 Aug 27, 2004
CARBINOXAMINE MALEATE
SOLUTION;ORAL
CARBINOXAMINE MALEATE
AA BOCA PHARMA LLC 4MG/5ML A040814 001 Feb 26, 2008
AA CYPRESS PHARM 4MG/5ML A090418 001 May 04, 2010
AA + MIKART 4MG/5ML A040458 001 Apr 25, 2003
SUSPENSION, EXTENDED RELEASE;ORAL
KARBINAL ER
+ TRIS PHARMA INC 4MG/5ML N022556 001 Mar 28, 2013
TABLET;ORAL
CARBINOXAMINE MALEATE
AA BOCA PHARMA LLC 4MG A040639 002 May 30, 2008
AA CYPRESS PHARM 4MG A090417 001 Aug 23, 2010
AA INVAGEN PHARMS 4MG A090435 001 Apr 15, 2010
AA LYNROSE LABS 4MG A090756 001 May 27, 2011
AA + MIKART 4MG A040442 001 Mar 19, 2003
CARBOPLATIN
INJECTABLE;INJECTION
CARBOPLATIN
AP BEDFORD 50MG/VIAL A076099 001 Oct 14, 2004
AP 150MG/VIAL A076099 002 Oct 14, 2004
AP 450MG/VIAL A076099 003 Oct 14, 2004
AP CIPLA LTD 50MG/VIAL A077383 001 Jan 27, 2006
AP 150MG/VIAL A077383 002 Jan 27, 2006
AP 450MG/VIAL A077383 003 Jan 27, 2006
AP FRESENIUS KABI USA 50MG/VIAL A076235 001 Oct 14, 2004
AP 150MG/VIAL A076235 002 Oct 14, 2004
AP 450MG/VIAL A076235 003 Oct 14, 2004
AP ONCO THERAPIES LTD 50MG/VIAL A091510 001 May 29, 2012
AP 150MG/VIAL A091510 002 May 29, 2012
AP 450MG/VIAL A091510 003 May 29, 2012
AP SANDOZ 50MG/VIAL A076959 001 Mar 18, 2005
AP 150MG/VIAL A076959 002 Mar 18, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-65( of 362)
CARBOPLATIN
INJECTABLE;INJECTION
CARBOPLATIN
AP 450MG/VIAL A076959 003 Mar 18, 2005
AP + WATSON LABS 50MG/VIAL A076162 001 Oct 14, 2004
AP + 150MG/VIAL A076162 002 Oct 14, 2004
AP + 450MG/VIAL A076162 003 Oct 14, 2004
INJECTABLE;IV (INFUSION)
CARBOPLATIN
AP ACTAVIS TOTOWA 50MG/5ML (10MG/ML) A078732 001 Feb 06, 2012
AP 150MG/15ML (10MG/ML) A078732 002 Feb 06, 2012
AP 450MG/45ML (10MG/ML) A078732 003 Feb 06, 2012
AP 600MG/60ML (10MG/ML) A078732 004 Feb 06, 2012
AP AKORN 50MG/5ML (10MG/ML) A090475 001 Jul 29, 2009
AP 150MG/15ML (10MG/ML) A090475 002 Jul 29, 2009
AP 450MG/45ML (10MG/ML) A090475 003 Jul 29, 2009
AP 600MG/60ML (10MG/ML) A091268 002 Jul 28, 2010
AP BEDFORD LABS 50MG/5ML (10MG/ML) A077244 001 Oct 15, 2004
AP 150MG/15ML (10MG/ML) A077244 002 Oct 15, 2004
AP 450MG/45ML (10MG/ML) A077244 003 Oct 15, 2004
AP 600MG/60ML (10MG/ML) A077244 004 Jan 20, 2006
AP CIPLA LTD 50MG/5ML (10MG/ML) A077861 001 Jan 18, 2007
AP 150MG/15ML (10MG/ML) A077861 002 Jan 18, 2007
AP 450MG/45ML (10MG/ML) A077861 003 Jan 18, 2007
AP 600MG/60ML (10MG/ML) A077861 004 Jan 18, 2007
AP EBEWE PHARMA 50MG/5ML (10MG/ML) A078280 001 May 08, 2008
AP 150MG/15ML (10MG/ML) A078280 002 May 08, 2008
AP 450MG/45ML (10MG/ML) A078280 003 May 08, 2008
AP FRESENIUS KABI ONCOL 50MG/5ML (10MG/ML) A077432 001 Sep 29, 2006
AP 150MG/15ML (10MG/ML) A077432 002 Sep 29, 2006
AP 450MG/45ML (10MG/ML) A077432 003 Sep 29, 2006
AP FRESENIUS KABI USA 450MG/45ML (10MG/ML) A077247 003 Oct 21, 2004
AP 450MG/45ML (10MG/ML) A077266 003 Feb 15, 2006
AP 600MG/60ML (10MG/ML) A077266 004 Feb 15, 2006
AP HOSPIRA 50MG/5ML (10MG/ML) A076517 001 Oct 14, 2004
AP 150MG/15ML (10MG/ML) A076517 002 Oct 14, 2004
AP 450MG/45ML (10MG/ML) A076517 003 Oct 14, 2004
AP 600MG/60ML (10MG/ML) A077059 001 Nov 23, 2004
AP MYLAN INSTITUTIONAL 50MG/5ML (10MG/ML) A077998 001 Apr 24, 2007
AP 150MG/15ML (10MG/ML) A077998 002 Apr 24, 2007
AP 450MG/45ML (10MG/ML) A077998 003 Apr 24, 2007
AP ONCO THERAPIES LTD 50MG/5ML (10MG/ML) A091063 001 Nov 09, 2011
AP 150MG/15ML (10MG/ML) A091063 002 Nov 09, 2011
AP 450MG/45ML (10MG/ML) A091063 003 Nov 09, 2011
AP 600MG/60ML (10MG/ML) A091063 004 Nov 09, 2011
AP + PHARMACHEMIE 50MG/5ML (10MG/ML) A077269 001 Oct 14, 2004
AP + 150MG/15ML (10MG/ML) A077269 002 Oct 14, 2004
AP + 450MG/45ML (10MG/ML) A077269 003 Oct 14, 2004
AP + 600MG/60ML (10MG/ML) A077269 004 Dec 28, 2007
AP PLIVA LACHEMA 50MG/5ML (10MG/ML) A078631 001 Dec 02, 2008
AP 150MG/15ML (10MG/ML) A078631 002 Dec 02, 2008
AP 450MG/45ML (10MG/ML) A078631 003 Dec 02, 2008
AP 600MG/60ML (10MG/ML) A078631 004 Dec 02, 2008
AP SAGENT PHARMS 50MG/5ML (10MG/ML) A077096 001 Jun 14, 2005
AP 150MG/15ML (10MG/ML) A077096 002 Jun 14, 2005
AP 450MG/45ML (10MG/ML) A077096 003 Jun 14, 2005
AP 600MG/60ML (10MG/ML) A077096 004 Jun 03, 2013
AP SUN PHARMA GLOBAL 50MG/5ML (10MG/ML) A077926 001 Sep 19, 2008
AP 150MG/15ML (10MG/ML) A077926 002 Sep 19, 2008
AP 450MG/45ML (10MG/ML) A077926 003 Sep 19, 2008
AP + TEVA PHARMS USA 50MG/5ML (10MG/ML) A077139 001 Sep 21, 2005
AP + 150MG/15ML (10MG/ML) A077139 002 Sep 21, 2005
AP + 450MG/45ML (10MG/ML) A077139 003 Sep 21, 2005
AP + 600MG/60ML (10MG/ML) A077139 004 Sep 21, 2005
+ ONCO THERAPIES LTD 1GM/100ML (10MG/ML) A091478 001 Nov 23, 2011
CARBOPROST TROMETHAMINE
INJECTABLE;INJECTION
HEMABATE
+ PHARMACIA AND UPJOHN EQ 0.25MG BASE/ML N017989 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-66( of 362)
CARFILZOMIB
POWDER;INTRAVENOUS
KYPROLIS
+ ONYX PHARMS 60MG/VIAL N202714 001 Jul 20, 2012
CARGLUMIC ACID
TABLET;ORAL
CARBAGLU
+ ORPHAN EUROPE 200MG N022562 001 Mar 18, 2010
CARISOPRODOL
TABLET;ORAL
CARISOPRODOL
AA ACCELRX LABS 350MG A040576 001 Jun 07, 2005
AA AUROBINDO PHARMA 350MG A040792 001 Aug 06, 2009
AA MIRROR PHARMS 350MG A040823 001 Oct 22, 2008
AA MUTUAL PHARM 350MG A089346 001 Oct 17, 1991
AA SUN PHARM INDS LTD 350MG A040755 001 Feb 27, 2007
AA VINTAGE PHARMS 350MG A040245 001 Sep 08, 1997
AA WATSON LABS 350MG A087499 001 Apr 20, 1982
SOMA
AA MEDA PHARMS 350MG N011792 001
+ 250MG N011792 004 Sep 13, 2007
CARMUSTINE
IMPLANT;INTRACRANIAL
GLIADEL
+ ARBOR PHARMS LLC 7.7MG N020637 001 Sep 23, 1996
INJECTABLE;INJECTION
BICNU
+ EMCURE PHARMS LTD 100MG/VIAL N017422 001
CARTEOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CARTEOLOL HYDROCHLORIDE
AT ALCON 1% A075476 001 Jan 03, 2000
AT BAUSCH AND LOMB 1% A075546 001 Jan 20, 2000
OCUPRESS
AT + NOVARTIS 1% N019972 001 May 23, 1990
CARVEDILOL
TABLET;ORAL
CARVEDILOL
AB APOTEX INC 3.125MG A078165 001 Sep 05, 2007
AB 6.25MG A078165 002 Sep 05, 2007
AB 12.5MG A078165 003 Sep 05, 2007
AB 25MG A078165 004 Sep 05, 2007
AB AUROBINDO PHARMA 3.125MG A078332 001 Sep 05, 2007
AB 6.25MG A078332 002 Sep 05, 2007
AB 12.5MG A078332 003 Sep 05, 2007
AB 25MG A078332 004 Sep 05, 2007
AB BEXIMCO USA 3.125MG A078384 001 Sep 05, 2007
AB 6.25MG A078384 002 Sep 05, 2007
AB 12.5MG A078384 003 Sep 05, 2007
AB 25MG A078384 004 Sep 05, 2007
AB CARACO 3.125MG A077346 004 Sep 05, 2007
AB 6.25MG A077346 001 Sep 05, 2007
AB 12.5MG A077346 002 Sep 05, 2007
AB 25MG A077346 003 Sep 05, 2007
AB CIPLA LTD 3.125MG A077474 001 Sep 05, 2007
AB 6.25MG A077474 002 Sep 05, 2007
AB 12.5MG A077474 003 Sep 05, 2007
AB 25MG A077474 004 Sep 05, 2007
AB DR REDDYS LABS LTD 3.125MG A076649 001 Sep 05, 2007
AB 6.25MG A076649 002 Sep 05, 2007
AB 12.5MG A076649 003 Sep 05, 2007
AB 25MG A076649 004 Sep 05, 2007
AB GLENMARK GENERICS 3.125MG A078251 001 Sep 05, 2007
AB 6.25MG A078251 002 Sep 05, 2007
AB 12.5MG A078251 003 Sep 05, 2007
AB 25MG A078251 004 Sep 05, 2007
AB HIKMA 3.125MG A077887 001 Sep 07, 2007
AB 6.25MG A077887 002 Sep 07, 2007
AB 12.5MG A077887 003 Sep 07, 2007
AB 25MG A077887 004 Sep 07, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-67( of 362)
CARVEDILOL
TABLET;ORAL
CARVEDILOL
AB LUPIN 3.125MG A078217 001 Sep 05, 2007
AB 6.25MG A078217 002 Sep 05, 2007
AB 12.5MG A078217 003 Sep 05, 2007
AB 25MG A078217 004 Sep 05, 2007
AB MYLAN 3.125MG A077316 001 Sep 05, 2007
AB 6.25MG A077316 002 Sep 05, 2007
AB 12.5MG A077316 003 Sep 05, 2007
AB 25MG A077316 004 Sep 05, 2007
AB PLIVA HRVATSKA DOO 3.125MG A078240 001 Oct 30, 2007
AB 6.25MG A078240 002 Oct 30, 2007
AB 12.5MG A078240 003 Oct 30, 2007
AB 25MG A078240 004 Oct 30, 2007
AB RANBAXY 3.125MG A076989 001 Sep 05, 2007
AB 6.25MG A076989 002 Sep 05, 2007
AB 12.5MG A076989 003 Sep 05, 2007
AB 25MG A076989 004 Sep 05, 2007
AB SANDOZ 3.125MG A078227 001 Sep 05, 2007
AB 6.25MG A078227 002 Sep 05, 2007
AB 12.5MG A078227 003 Sep 05, 2007
AB 25MG A078227 004 Sep 05, 2007
AB TARO 3.125MG A077780 001 Sep 05, 2007
AB 6.25MG A077780 002 Sep 05, 2007
AB 12.5MG A077780 003 Sep 05, 2007
AB 25MG A077780 004 Sep 05, 2007
AB TEVA 3.125MG A076373 001 Sep 05, 2007
AB 6.25MG A076373 002 Sep 05, 2007
AB 12.5MG A076373 003 Sep 05, 2007
AB 25MG A076373 004 Sep 05, 2007
AB ZYDUS PHARMS USA INC 3.125MG A077614 004 Sep 05, 2007
AB 6.25MG A077614 001 Sep 05, 2007
AB 12.5MG A077614 002 Sep 05, 2007
AB 25MG A077614 003 Sep 05, 2007
COREG
AB SMITHKLINE BEECHAM 3.125MG N020297 004 May 29, 1997
AB 6.25MG N020297 003 Sep 14, 1995
AB + 12.5MG N020297 002 Sep 14, 1995
AB 25MG N020297 001 Sep 14, 1995
CARVEDILOL PHOSPHATE
CAPSULE, EXTENDED RELEASE;ORAL
COREG CR
SB PHARMCO 10MG N022012 001 Oct 20, 2006
20MG N022012 002 Oct 20, 2006
+ 40MG N022012 003 Oct 20, 2006
80MG N022012 004 Oct 20, 2006
CASPOFUNGIN ACETATE
INJECTABLE;IV (INFUSION)
CANCIDAS
+ MERCK 50MG/VIAL N021227 001 Jan 26, 2001
+ 70MG/VIAL N021227 002 Jan 26, 2001
CEFACLOR
CAPSULE;ORAL
CEFACLOR
AB HIKMA EQ 250MG BASE A065350 001 Apr 03, 2007
AB + EQ 500MG BASE A065350 002 Apr 03, 2007
AB YUNG SHIN PHARM EQ 250MG BASE A065146 001 Jan 22, 2004
AB EQ 500MG BASE A065146 002 Jan 22, 2004
FOR SUSPENSION;ORAL
CEFACLOR
AB YUNG SHIN PHARM EQ 125MG BASE/5ML A065412 001 Feb 17, 2012
AB EQ 187MG BASE/5ML A065412 002 Feb 17, 2012
AB EQ 250MG BASE/5ML A065412 003 Feb 17, 2012
AB EQ 375MG BASE/5ML A065412 004 Feb 17, 2012
TABLET, EXTENDED RELEASE;ORAL
CEFACLOR
TEVA EQ 375MG BASE A065058 001 Sep 04, 2002
+ EQ 500MG BASE A065058 002 Sep 04, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-68( of 362)
CEFADROXIL/CEFADROXIL HEMIHYDRATE
CAPSULE;ORAL
CEFADROXIL
AB AUROBINDO PHARMA EQ 500MG BASE A065352 001 Jan 25, 2007
AB HIKMA EQ 500MG BASE A065311 001 Feb 07, 2006
AB LUPIN EQ 500MG BASE A065392 001 May 29, 2007
AB ORCHID HLTHCARE EQ 500MG BASE A065309 001 Sep 18, 2006
AB SANDOZ EQ 500MG BASE A062291 001
AB + TEVA PHARMS EQ 500MG BASE A065282 001 Jan 20, 2006
FOR SUSPENSION;ORAL
CEFADROXIL
AB AUROBINDO EQ 250MG BASE/5ML A065349 001 Apr 25, 2013
AB EQ 500MG BASE/5ML A065349 002 Apr 25, 2013
AB HIKMA PHARMS EQ 250MG BASE/5ML A091036 001 Nov 28, 2012
AB EQ 500MG BASE/5ML A091036 002 Nov 28, 2012
AB LUPIN EQ 250MG BASE/5ML A065396 001 Feb 21, 2008
AB + EQ 500MG BASE/5ML A065396 002 Feb 21, 2008
AB ORCHID HLTHCARE EQ 250MG BASE/5ML A065307 002 Oct 16, 2006
AB EQ 500MG BASE/5ML A065307 003 Oct 16, 2006
AB RANBAXY EQ 250MG BASE/5ML A065115 002 Mar 26, 2003
AB EQ 500MG BASE/5ML A065115 003 Mar 26, 2003
EQ 125MG BASE/5ML A065115 001 Mar 26, 2003
TABLET;ORAL
CEFADROXIL
AB HIKMA EQ 1GM BASE A065260 001 Mar 30, 2006
AB ORCHID HLTHCARE EQ 1GM BASE A065301 001 Sep 18, 2006
+ TEVA PHARMS EQ 1GM BASE A062774 001 Apr 08, 1987
CEFAZOLIN SODIUM
INJECTABLE;INJECTION
CEFAZOLIN SODIUM
AP ACS DOBFAR EQ 1GM BASE/VIAL A065303 002 Oct 22, 2008
AP EQ 10GM BASE/VIAL A065306 001 Oct 22, 2008
AP EQ 500MG BASE/VIAL A065303 001 Oct 22, 2008
AP HIKMA FARMACEUTICA EQ 1GM BASE/VIAL A065047 002 Sep 18, 2001
AP EQ 10GM BASE/VIAL A065143 001 Oct 18, 2004
AP EQ 500MG BASE/VIAL A065047 001 Sep 18, 2001
AP + HOSPIRA INC EQ 1GM BASE/VIAL A065226 002 Apr 21, 2005
AP + EQ 1GM BASE/VIAL A065244 001 Aug 12, 2005
AP + EQ 10GM BASE/VIAL A065247 001 Aug 12, 2005
AP + EQ 500MG BASE/VIAL A065226 001 Apr 21, 2005
AP SANDOZ EQ 1GM BASE/VIAL A062831 002 Dec 09, 1988
AP EQ 1GM BASE/VIAL A065345 001 May 09, 2007
AP EQ 10GM BASE/VIAL A062831 003 Sep 25, 1992
AP EQ 500MG BASE/VIAL A062831 001 Dec 09, 1988
AP STERI PHARMA EQ 1GM BASE/VIAL A063207 001 Dec 27, 1991
AP EQ 1GM BASE/VIAL A063208 001 Dec 27, 1991
AP EQ 10GM BASE/VIAL A063209 001 Dec 27, 1991
AP + EQ 20GM BASE/VIAL A063209 002 Apr 30, 1999
AP EQ 500MG BASE/VIAL A063214 001 Dec 27, 1991
AP EQ 500MG BASE/VIAL A063216 001 Dec 27, 1991
KEFZOL
AP ACS DOBFAR EQ 1GM BASE/VIAL A061773 003
AP EQ 10GM BASE/VIAL A061773 004
AP EQ 500MG BASE/VIAL A061773 002
ANCEF IN PLASTIC CONTAINER
+ BAXTER HLTHCARE EQ 10MG BASE/ML A063002 001 Mar 28, 1991
+ EQ 20MG BASE/ML A063002 002 Mar 28, 1991
CEFAZOLIN AND DEXTROSE
+ B BRAUN EQ 1GM BASE/VIAL N050779 002 Jul 27, 2000
EQ 2GM BASE/VIAL N050779 003 Jan 13, 2012
CEFAZOLIN SODIUM
+ SAMSON MEDCL EQ 100GM BASE/VIAL A065141 001 Nov 29, 2006
+ EQ 300GM BASE/VIAL A065141 002 Nov 29, 2006
CEFDINIR
CAPSULE;ORAL
CEFDINIR
AB AUROBINDO PHARMA 300MG A065434 001 Jan 07, 2008
AB LUPIN 300MG A065264 001 May 19, 2006
AB ORCHID HLTHCARE 300MG A065418 001 Jul 18, 2007
AB + SANDOZ 300MG A065330 001 Apr 06, 2007
AB TEVA PHARMS 300MG A065368 001 May 09, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-69( of 362)
CEFDINIR
FOR SUSPENSION;ORAL
CEFDINIR
AB AUROBINDO PHARMA 125MG/5ML A065473 001 Dec 14, 2007
AB 250MG/5ML A065473 002 Dec 14, 2007
AB LUPIN 125MG/5ML A065259 001 May 31, 2006
AB 250MG/5ML A065259 002 May 07, 2007
AB ORCHID HLTHCARE 125MG/5ML A065429 001 Jul 18, 2007
AB 250MG/5ML A065429 002 Jul 18, 2007
AB SANDOZ 125MG/5ML A065337 001 Apr 06, 2007
AB + 250MG/5ML A065337 002 Apr 06, 2007
AB TEVA PHARMS 125MG/5ML A065332 001 May 04, 2007
AB 250MG/5ML A065332 002 May 04, 2007
CEFDITOREN PIVOXIL
TABLET;ORAL
SPECTRACEF
VANSEN PHARMA 200MG N021222 001 Aug 29, 2001
+ 400MG N021222 002 Jul 21, 2008
CEFEPIME HYDROCHLORIDE
INJECTABLE;INJECTION
CEFEPIME HYDROCHLORIDE
AP ACS DOBFAR EQ 1GM BASE/VIAL A065441 001 Mar 20, 2008
AP EQ 2GM BASE/VIAL A065441 002 Mar 20, 2008
AP HOSPIRA INC EQ 1GM BASE/VIAL A065369 002 Jun 18, 2007
AP EQ 1GM BASE/VIAL A202268 001 Jul 30, 2012
AP EQ 2GM BASE/VIAL A065369 003 Jun 18, 2007
AP EQ 2GM BASE/VIAL A202268 002 Jul 30, 2012
AP EQ 500MG BASE/VIAL A065369 001 Jun 18, 2007
MAXIPIME
AP + HOSPIRA INC EQ 1GM BASE/VIAL N050679 002 Jan 18, 1996
AP + EQ 2GM BASE/VIAL N050679 003 Jan 18, 1996
AP + EQ 500MG BASE/VIAL N050679 001 Jan 18, 1996
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
B BRAUN EQ 1GM BASE/VIAL N050821 001 May 06, 2010
EQ 2GM BASE/VIAL N050821 002 May 06, 2010
CEFEPIME IN PLASTIC CONTAINER
+ BAXTER HLTHCARE EQ 1GM BASE/50ML (EQ 20MG BASE/ML) N050817 001 Aug 05, 2008
+ EQ 2GM BASE/100ML (EQ 20MG BASE/ML) N050817 002 Aug 05, 2008
CEFIXIME
CAPSULE;ORAL
SUPRAX
+ LUPIN LTD 400MG N203195 001 Jun 01, 2012
FOR SUSPENSION;ORAL
SUPRAX
+ LUPIN LTD 500MG/5ML N202091 001 Feb 20, 2013
LUPIN PHARMS 100MG/5ML A065129 001 Feb 23, 2004
200MG/5ML A065355 001 Apr 10, 2007
TABLET;ORAL
SUPRAX
+ LUPIN PHARMS 400MG A065130 001 Feb 12, 2004
TABLET, CHEWABLE;ORAL
SUPRAX
LUPIN LTD 100MG A065380 001 Oct 25, 2010
150MG A065380 002 Oct 25, 2010
+ 200MG A065380 003 Oct 25, 2010
CEFOTAXIME SODIUM
INJECTABLE;INJECTION
CEFOTAXIME
AP HIKMA EQ 1GM BASE/VIAL A065072 002 Nov 20, 2002
AP EQ 2GM BASE/VIAL A065072 003 Nov 20, 2002
AP EQ 10GM BASE/VIAL A065071 001 Nov 20, 2002
AP EQ 500MG BASE/VIAL A065072 001 Nov 20, 2002
AP WOCKHARDT EQ 1GM BASE/VIAL A065197 001 Aug 29, 2006
CEFOTAXIME SODIUM
AP HOSPIRA INC EQ 1GM BASE/VIAL A065290 002 Aug 11, 2006
AP EQ 1GM BASE/VIAL A065293 001 Aug 10, 2006
AP EQ 2GM BASE/VIAL A065290 003 Aug 11, 2006
AP EQ 2GM BASE/VIAL A065293 002 Aug 10, 2006
AP EQ 10GM BASE/VIAL A065292 001 Aug 10, 2006
AP EQ 500MG BASE/VIAL A065290 001 Aug 11, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-70( of 362)
CEFOTAXIME SODIUM
INJECTABLE;INJECTION
CEFOTAXIME SODIUM
AP LUPIN EQ 1GM BASE/VIAL A065124 002 Sep 24, 2003
AP EQ 2GM BASE/VIAL A065124 003 Sep 24, 2003
AP EQ 500MG BASE/VIAL A065124 001 Sep 24, 2003
AP WOCKHARDT EQ 2GM BASE/VIAL A065197 003 Jun 20, 2008
AP EQ 500MG BASE/VIAL A065197 002 Jun 20, 2008
CLAFORAN
AP + SANOFI AVENTIS US EQ 1GM BASE/VIAL A062659 001 Jan 13, 1987
AP + EQ 1GM BASE/VIAL N050547 002
AP + EQ 2GM BASE/VIAL A062659 002 Jan 13, 1987
AP + EQ 2GM BASE/VIAL N050547 003
AP + EQ 10GM BASE/VIAL N050547 004 Dec 29, 1983
AP + EQ 500MG BASE/VIAL N050547 001
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
+ SANOFI AVENTIS US EQ 20MG BASE/ML N050596 002 May 20, 1985
+ EQ 40MG BASE/ML N050596 004 May 20, 1985
CEFOTETAN DISODIUM
INJECTABLE;INJECTION
CEFOTETAN
AP + FRESENIUS KABI USA EQ 1GM BASE/VIAL A065374 001 Aug 09, 2007
AP + EQ 2GM BASE/VIAL A065374 002 Aug 09, 2007
AP + EQ 10GM BASE/VIAL A065375 001 Aug 09, 2007
AP WEST-WARD PHARM CORP EQ 1GM BASE/VIAL A091031 001 Oct 26, 2011
AP EQ 2GM BASE/VIAL A091031 002 Oct 26, 2011
AP EQ 10GM BASE/VIAL A091030 001 Oct 26, 2011
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
+ B BRAUN EQ 1GM BASE/VIAL A065430 001 Aug 09, 2007
+ EQ 2GM BASE/VIAL A065430 002 Aug 09, 2007
CEFOXITIN SODIUM
INJECTABLE;INJECTION
CEFOXITIN
AP + ACS DOBFAR EQ 1GM BASE/VIAL A065414 001 Jun 12, 2009
AP + EQ 2GM BASE/VIAL A065414 002 Jun 12, 2009
AP + EQ 10GM BASE/VIAL A065415 001 May 19, 2010
AP ANTIBIOTICOS BRASIL EQ 1GM BASE/VIAL A065467 001 Aug 31, 2011
AP EQ 2GM BASE/VIAL A065467 002 Aug 31, 2011
AP EQ 10GM BASE/VIAL A065464 001 Aug 31, 2011
AP HIKMA FARMACEUTICA EQ 1GM BASE/VIAL A065238 001 Mar 12, 2010
AP EQ 2GM BASE/VIAL A065238 002 Mar 12, 2010
AP EQ 10GM BASE/VIAL A065239 001 Mar 02, 2010
AP HIKMA MAPLE EQ 1GM BASE/VIAL A065051 001 Sep 11, 2000
AP EQ 2GM BASE/VIAL A065051 002 Sep 11, 2000
AP EQ 10GM BASE/VIAL A065050 001 Sep 11, 2000
AP HOSPIRA INC EQ 1GM BASE/VIAL A065313 001 Jan 23, 2006
AP EQ 2GM BASE/VIAL A065313 002 Jan 23, 2006
AP EQ 10GM BASE/VIAL A065312 001 Feb 13, 2006
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
AP B BRAUN EQ 1GM BASE/VIAL A065214 001 Mar 10, 2006
AP EQ 2GM BASE/VIAL A065214 002 Mar 10, 2006
MEFOXIN IN PLASTIC CONTAINER
+ MYLAN INSTITUTIONAL EQ 20MG BASE/ML A063182 001 Jan 25, 1993
+ EQ 40MG BASE/ML A063182 002 Jan 25, 1993
CEFPODOXIME PROXETIL
FOR SUSPENSION;ORAL
CEFPODOXIME PROXETIL
AB AUROBINDO PHARMA LTD EQ 50MG BASE/5ML A065409 001 Jun 08, 2007
AB EQ 100MG BASE/5ML A065409 002 Jun 08, 2007
AB RANBAXY EQ 50MG BASE/5ML A065082 001 May 31, 2002
AB EQ 100MG BASE/5ML A065082 002 May 31, 2002
AB SANDOZ EQ 50MG BASE/5ML A090031 001 Jan 14, 2009
AB + EQ 100MG BASE/5ML A090031 002 Jan 14, 2009
TABLET;ORAL
CEFPODOXIME PROXETIL
AB AUROBINDO PHARMA EQ 100MG BASE A065370 001 Jun 11, 2007
AB EQ 200MG BASE A065370 002 Jun 11, 2007
AB ORCHID HLTHCARE EQ 100MG BASE A065388 001 Nov 14, 2007
AB EQ 200MG BASE A065388 002 Nov 14, 2007
AB RANBAXY EQ 100MG BASE A065083 001 Aug 20, 2003
AB EQ 200MG BASE A065083 002 Aug 20, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-71( of 362)
CEFPODOXIME PROXETIL
TABLET;ORAL
CEFPODOXIME PROXETIL
AB SANDOZ EQ 100MG BASE A065462 001 May 28, 2008
AB + EQ 200MG BASE A065462 002 May 28, 2008
CEFPROZIL
FOR SUSPENSION;ORAL
CEFPROZIL
AB APOTEX INC 125MG/5ML A065351 001 Feb 29, 2012
AB 250MG/5ML A065351 002 Feb 29, 2012
AB AUROBINDO PHARMA 125MG/5ML A065381 001 Jan 30, 2007
AB 250MG/5ML A065381 002 Jan 30, 2007
AB LUPIN 125MG/5ML A065261 001 Dec 19, 2005
AB + 250MG/5ML A065261 002 Dec 19, 2005
AB ORCHID HLTHCARE 125MG/5ML A065284 002 Dec 30, 2005
AB 250MG/5ML A065284 001 Dec 30, 2005
AB SANDOZ 125MG/5ML A065257 001 Dec 08, 2005
AB 250MG/5ML A065257 002 Dec 08, 2005
AB TEVA PHARMS 125MG/5ML A065236 001 Dec 08, 2005
AB 250MG/5ML A065236 002 Dec 08, 2005
TABLET;ORAL
CEFPROZIL
AB APOTEX INC 250MG A065327 001 Mar 26, 2008
AB 500MG A065327 002 Mar 26, 2008
AB AUROBINDO PHARMA LTD 250MG A065340 001 May 24, 2007
AB 500MG A065340 002 May 24, 2007
AB LUPIN 250MG A065276 001 Dec 08, 2005
AB + 500MG A065276 002 Dec 08, 2005
AB ORCHID HLTHCARE 250MG A065267 001 Dec 19, 2005
AB 500MG A065267 002 Dec 19, 2005
AB SANDOZ 250MG A065235 001 Nov 14, 2005
AB 500MG A065235 002 Nov 14, 2005
AB TEVA 250MG A065208 001 Dec 06, 2005
AB 500MG A065208 002 Dec 06, 2005
AB WOCKHARDT 250MG A065428 001 Jun 14, 2007
AB 500MG A065428 002 Jun 14, 2007
CEFTAROLINE FOSAMIL
POWDER;IV (INFUSION)
TEFLARO
CEREXA 400MG/VIAL N200327 001 Oct 29, 2010
+ 600MG/VIAL N200327 002 Oct 29, 2010
CEFTAZIDIME
INJECTABLE;INJECTION
CEFTAZIDIME
AP ACS DOBFAR 1GM/VIAL A062640 002 Nov 20, 1985
AP 2GM/VIAL A062640 003 Nov 20, 1985
AP 6GM/VIAL A062640 004 Feb 03, 1992
AP 500MG/VIAL A062640 001 Nov 20, 1985
AP WOCKHARDT 1GM/VIAL A065196 001 Oct 15, 2008
FORTAZ
AP + COVIS PHARMA 1GM/VIAL N050578 002 Jul 19, 1985
AP + 2GM/VIAL N050578 003 Jul 19, 1985
AP + 6GM/VIAL N050578 004 Jul 19, 1985
AP + 500MG/VIAL N050578 001 Jul 19, 1985
TAZICEF
AP HOSPIRA 1GM/VIAL A062662 002 Mar 06, 1986
AP 1GM/VIAL A064032 001 Oct 31, 1993
AP 2GM/VIAL A062662 003 Mar 06, 1986
AP 2GM/VIAL A064032 002 Oct 31, 1993
AP 6GM/VIAL A062662 004 Mar 06, 1986
AP 500MG/VIAL A062662 001 Mar 06, 1986
CEFTAZIDIME IN DEXTROSE CONTAINER
B BRAUN EQ 1GM BASE N050823 001 Jun 13, 2011
+ EQ 2GM BASE N050823 002 Jun 13, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-72( of 362)
CEFTAZIDIME SODIUM
INJECTABLE;INJECTION
FORTAZ IN PLASTIC CONTAINER
+ COVIS PHARMA EQ 20MG BASE/ML N050634 002 Apr 28, 1989
+ EQ 40MG BASE/ML N050634 003 Apr 28, 1989
CEFTIBUTEN DIHYDRATE
CAPSULE;ORAL
CEDAX
+ PERNIX THERAP EQ 400MG BASE N050685 002 Dec 20, 1995
FOR SUSPENSION;ORAL
CEDAX
+ PERNIX THERAP EQ 90MG BASE/5ML N050686 001 Dec 20, 1995
CEFTRIAXONE SODIUM
INJECTABLE;IM-IV
CEFTRIAXONE
AP AKORN INC EQ 1GM BASE/VIAL A065305 003 Jan 11, 2008
AP EQ 2GM BASE/VIAL A065305 004 Jan 11, 2008
AP EQ 250MG BASE/VIAL A065305 001 Jan 11, 2008
AP EQ 500MG BASE/VIAL A065305 002 Jan 11, 2008
AP BEDFORD EQ 1GM BASE/VIAL A065465 003 Aug 18, 2008
AP EQ 2GM BASE/VIAL A065465 004 Aug 18, 2008
AP EQ 250MG BASE/VIAL A065465 001 Aug 18, 2008
AP EQ 500MG BASE/VIAL A065465 002 Aug 18, 2008
AP FRESENIUS KABI USA EQ 250MG BASE/VIAL A065245 001 Feb 15, 2006
AP HIKMA FARMACEUTICA EQ 1GM BASE/VIAL A065342 003 Jan 10, 2008
AP EQ 2GM BASE/VIAL A065342 004 Jan 10, 2008
AP EQ 250MG BASE/VIAL A065342 001 Jan 10, 2008
AP EQ 500MG BASE/VIAL A065342 002 Jan 10, 2008
AP HOSPIRA INC EQ 1GM BASE/VIAL A065230 003 Aug 02, 2005
AP EQ 2GM BASE/VIAL A065230 004 Aug 02, 2005
AP EQ 250MG BASE/VIAL A065230 001 Aug 02, 2005
AP EQ 500MG BASE/VIAL A065230 002 Aug 02, 2005
AP LUPIN EQ 1GM BASE/VIAL A065125 003 Sep 30, 2003
AP EQ 2GM BASE/VIAL A065125 004 Sep 30, 2003
AP EQ 250MG BASE/VIAL A065125 001 Sep 30, 2003
AP EQ 500MG BASE/VIAL A065125 002 Sep 30, 2003
AP + SANDOZ EQ 1GM BASE/VIAL A065169 003 May 09, 2005
AP + EQ 2GM BASE/VIAL A065169 004 May 09, 2005
AP + EQ 250MG BASE/VIAL A065169 001 May 09, 2005
AP + EQ 500MG BASE/VIAL A065169 002 May 09, 2005
AP TEVA PHARMS USA EQ 1GM BASE/VIAL A065227 003 Mar 15, 2007
AP EQ 2GM BASE/VIAL A065227 004 Mar 15, 2007
AP EQ 250MG BASE/VIAL A065227 001 Mar 15, 2007
AP EQ 500MG BASE/VIAL A065227 002 Mar 15, 2007
AP WOCKHARDT EQ 2GM BASE/VIAL A065391 003 Apr 12, 2007
AP EQ 250MG BASE/VIAL A065391 001 Apr 12, 2007
AP EQ 500MG BASE/VIAL A065391 002 Apr 12, 2007
INJECTABLE;INJECTION
CEFTRIAXONE
AP ACS DOBFAR EQ 1GM BASE/VIAL A065329 002 Jul 24, 2008
AP EQ 2GM BASE/VIAL A065329 003 Jul 24, 2008
AP EQ 10GM BASE/VIAL A065328 001 Jul 24, 2008
AP EQ 500MG BASE/VIAL A065329 001 Jul 24, 2008
AP BEDFORD EQ 10GM BASE/VIAL A065475 001 Aug 18, 2008
AP HOSPIRA INC EQ 1GM BASE/VIAL A065231 001 Aug 02, 2005
AP EQ 1GM BASE/VIAL A202563 001 Aug 20, 2012
AP EQ 2GM BASE/VIAL A065231 002 Aug 02, 2005
AP EQ 2GM BASE/VIAL A202563 002 Aug 20, 2012
AP EQ 10GM BASE/VIAL A065232 001 Aug 02, 2005
AP LUPIN EQ 10GM BASE/VIAL A065263 001 Sep 12, 2006
AP + SANDOZ EQ 10GM BASE/VIAL A065168 001 May 17, 2005
AP + SANDOZ INC EQ 1GM BASE/VIAL A065204 001 May 03, 2005
AP + EQ 2GM BASE/VIAL A065204 002 May 03, 2005
AP STERI PHARMA EQ 10GM BASE/VIAL A065269 001 Feb 28, 2007
AP STRIDES ARCOLAB LTD EQ 10GM BASE/VIAL A091068 001 Jan 07, 2013
AP WOCKHARDT EQ 1GM BASE/VIAL A065180 001 May 12, 2006
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
AP + B BRAUN EQ 1GM BASE/VIAL N050796 001 Apr 20, 2005
AP + EQ 2GM BASE/VIAL N050796 002 Apr 20, 2005
ROCEPHIN
AP + HOFFMANN LA ROCHE EQ 1GM BASE/VIAL A063239 003 Aug 13, 1993
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-73( of 362)
CEFTRIAXONE SODIUM
INJECTABLE;INJECTION
ROCEPHIN
AP + EQ 500MG BASE/VIAL A063239 002 Aug 13, 1993
CEFTRIAXONE IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 20MG BASE/ML A065224 001 Aug 23, 2005
EQ 40MG BASE/ML A065224 002 Aug 23, 2005
CEFUROXIME AXETIL
FOR SUSPENSION;ORAL
CEFTIN
AB GLAXOSMITHKLINE EQ 125MG BASE/5ML N050672 001 Jun 30, 1994
AB + EQ 250MG BASE/5ML N050672 002 Apr 29, 1997
CEFUROXIME AXETIL
AB RANBAXY EQ 125MG BASE/5ML A065323 001 Feb 05, 2008
AB EQ 250MG BASE/5ML A065323 002 Feb 05, 2008
TABLET;ORAL
CEFTIN
AB GLAXOSMITHKLINE EQ 125MG BASE N050605 001 Dec 28, 1987
AB EQ 250MG BASE N050605 002 Dec 28, 1987
AB + EQ 500MG BASE N050605 003 Dec 28, 1987
CEFUROXIME AXETIL
AB ALKEM LABS LTD EQ 250MG BASE A065496 001 Jun 07, 2010
AB EQ 500MG BASE A065496 002 Jun 07, 2010
AB APOTEX EQ 250MG BASE A065069 001 Oct 02, 2002
AB EQ 500MG BASE A065069 002 Oct 02, 2002
AB AUROBINDO PHARMA LTD EQ 125MG BASE A065308 001 Mar 29, 2006
AB EQ 250MG BASE A065308 002 Mar 29, 2006
AB EQ 500MG BASE A065308 003 Mar 29, 2006
AB LUPIN EQ 250MG BASE A065135 001 Jul 25, 2003
AB EQ 500MG BASE A065135 002 Jul 25, 2003
AB ORCHID HLTHCARE EQ 125MG BASE A065359 001 Feb 15, 2008
AB EQ 250MG BASE A065359 002 Feb 15, 2008
AB EQ 500MG BASE A065359 003 Feb 15, 2008
AB RANBAXY EQ 125MG BASE A065118 001 Apr 25, 2003
AB EQ 250MG BASE A065118 002 Apr 25, 2003
AB EQ 500MG BASE A065118 003 Apr 25, 2003
AB TEVA EQ 250MG BASE A065190 001 Oct 18, 2004
AB EQ 500MG BASE A065190 002 Oct 18, 2004
AB WOCKHARDT EQ 125MG BASE A065166 001 Jul 29, 2005
AB EQ 250MG BASE A065166 002 Jul 29, 2005
AB EQ 500MG BASE A065166 003 Jul 29, 2005
CEFUROXIME SODIUM
INJECTABLE;IM-IV
CEFUROXIME SODIUM
AB HIKMA FARMACEUTICA EQ 750MG BASE/VIAL A065048 001 Jan 09, 2004
AB STERI PHARMA EQ 750MG BASE/VIAL A064125 001 May 30, 1997
ZINACEF
AB + COVIS PHARMA EQ 750MG BASE/VIAL N050558 002 Oct 19, 1983
CEFUROXIME SODIUM
AP HOSPIRA INC EQ 750MG BASE/VIAL A065483 001 Oct 15, 2008
INJECTABLE;INJECTION
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
AP + B BRAUN EQ 1.5GM BASE/VIAL N050780 002 Feb 21, 2001
AP + EQ 750MG BASE/VIAL N050780 001 Feb 21, 2001
CEFUROXIME SODIUM
AP HIKMA FARMACEUTICA EQ 1.5GM BASE/VIAL A065048 002 Jan 09, 2004
AP EQ 7.5GM BASE/VIAL A065046 001 Jan 09, 2004
AP HOSPIRA INC EQ 1.5GM BASE/VIAL A065483 002 Oct 15, 2008
AP EQ 1.5GM BASE/VIAL A065503 001 Oct 15, 2008
AP EQ 7.5GM BASE/VIAL A065484 001 Oct 15, 2008
AP STERI PHARMA EQ 1.5GM BASE/VIAL A064125 002 May 30, 1997
AP EQ 7.5GM BASE/VIAL A064124 001 May 30, 1997
AP TEVA PHARMS EQ 7.5GM BASE/VIAL A064191 001 Apr 16, 1998
ZINACEF
AP + COVIS PHARMA EQ 1.5GM BASE/VIAL N050558 003 Oct 19, 1983
AP + EQ 7.5GM BASE/VIAL N050558 004 Oct 23, 1986
ZINACEF IN PLASTIC CONTAINER
+ COVIS PHARMA EQ 30MG BASE/ML N050643 002 Apr 28, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
CELECOXIB
CAPSULE;ORAL
CELEBREX
GD SEARLE
+
CEPHALEXIN
CAPSULE;ORAL
CEPHALEXIN
AB ALKEM LABS LTD
AB
AB
AB AUROBINDO PHARMA LTD
AB
AB BELCHER PHARMS
AB
AB FACTA FARMA
AB
AB HIKMA
AB
AB LUPIN
AB
AB ORCHID HLTHCARE
AB
AB RANBAXY
AB
AB STEVENS J
AB SUN PHARM INDS (IN)
AB
AB TEVA
AB
AB YUNG SHIN PHARM
AB
KEFLEX
AB SHIONOGI INC
AB
AB +
CEPHALEXIN
ALKEM LABS LTD
FOR SUSPENSION;ORAL
CEPHALEXIN
AB FACTA FARMA
AB +
AB HIKMA PHARMS
AB
AB LUPIN
AB
AB ORCHID HLTHCARE
AB
AB RANBAXY
AB
AB TEVA
AB
AB YUNG SHIN PHARM
AB
TABLET;ORAL
CEPHALEXIN
TEVA
+
CETIRIZINE HYDROCHLORIDE
SYRUP;ORAL
CETIRIZINE HYDROCHLORIDE
AA AMNEAL PHARMS
AA BIO PHARM INC
AA BRECKENRIDGE PHARM
AA CARACO
AA PERRIGO R AND D
AA SILARX
AA TARO
AA TEVA PHARMS
50MG
100MG
200MG
400MG
EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
EQ 333MG BASE
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE
EQ 500MG BASE
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
3-74( of 362)
N020998 004 Dec 15, 2006
N020998 001 Dec 31, 1998
N020998 002 Dec 31, 1998
N020998 003 Aug 29, 2002
A090836 001 Dec 20, 2010
A090836 002 Dec 20, 2010
A090836 004 Mar 29, 2013
A065253 001 Nov 16, 2005
A065253 002 Nov 16, 2005
A062713 001 Jul 15, 1988
A062713 002 Jul 15, 1988
A062118 001
A062118 002
A065215 001 Jan 24, 2006
A065215 002 Jan 24, 2006
A065229 001 Nov 25, 2005
A065229 002 Nov 25, 2005
A065248 001 Jun 28, 2005
A065248 002 Jun 28, 2005
A065007 001 Sep 16, 1999
A065007 002 Sep 16, 1999
A062870 001 Mar 17, 1988
A062791 001 Jun 11, 1987
A062791 002 Jun 11, 1987
A062702 001 Feb 13, 1987
A062702 002 Feb 13, 1987
A065152 001 Feb 24, 2005
A065152 002 Feb 24, 2005
N050405 002
N050405 003
N050405 005 May 12, 2006
A090836 003 Mar 29, 2013
A062117 002
A062117 003
A065444 001 Aug 28, 2009
A065444 002 Aug 28, 2009
A065234 001 Aug 17, 2005
A065234 002 Aug 17, 2005
A065326 001 Jul 10, 2006
A065326 002 Jul 10, 2006
A065081 001 Jul 27, 2001
A065081 002 Jul 27, 2001
A062703 001 Feb 13, 1987
A062703 002 Feb 13, 1987
A065336 001 Jul 25, 2007
A065336 002 Jul 25, 2007
A063023 001 Jan 12, 1989
A063024 001 Jan 12, 1989
A090766 001 Oct 07, 2009
A078870 001 Apr 27, 2009
A078488 001 Oct 06, 2008
A090191 001 Nov 12, 2009
A078398 001 Jun 17, 2008
A078876 001 May 11, 2012
A076601 001 Jun 20, 2008
A077279 001 May 27, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-75( of 362)
CETIRIZINE HYDROCHLORIDE
SYRUP;ORAL
CETIRIZINE HYDROCHLORIDE
AA VINTAGE 5MG/5ML A078496 001 Sep 25, 2009
AA WOCKHARDT 5MG/5ML A078757 001 Aug 28, 2009
ZYRTEC
AA + MCNEIL CONSUMER 5MG/5ML N020346 001 Sep 27, 1996
CETRORELIX
INJECTABLE;INJECTION
CETROTIDE
+ EMD SERONO INC EQ 0.25MG BASE/ML N021197 001 Aug 11, 2000
CEVIMELINE HYDROCHLORIDE
CAPSULE;ORAL
CEVIMELINE
AB APOTEX INC 30MG A091260 001 Aug 25, 2011
CEVIMELINE HYDROCHLORIDE
AB ROXANE 30MG A091591 001 Jul 08, 2013
EVOXAC
AB + DAIICHI SANKYO 30MG N020989 002 Jan 11, 2000
CHENODIOL
TABLET;ORAL
CHENODIOL
+ NEXGEN PHARMA 250MG A091019 001 Oct 22, 2009
CHLORAMBUCIL
TABLET;ORAL
LEUKERAN
+ ASPEN GLOBAL INC 2MG N010669 002
CHLORAMPHENICOL SODIUM SUCCINATE
INJECTABLE;INJECTION
CHLORAMPHENICOL SODIUM SUCCINATE
+ FRESENIUS KABI USA EQ 1GM BASE/VIAL A062365 001 Aug 25, 1982
CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE;ORAL
CHLORDIAZEPOXIDE HYDROCHLORIDE
AB BARR 5MG A084768 001
AB 10MG A083116 001
AB 25MG A084769 001
AB USL PHARMA 10MG A084623 001
AB WATSON LABS 5MG A086383 001
AB 10MG A086294 001
AB 25MG A086382 001
LIBRIUM
AB VALEANT PHARM INTL 5MG A085461 001
AB 10MG A085472 001
AB + 25MG A085475 001
CHLORHEXIDINE GLUCONATE
SOLUTION;DENTAL
CHLORHEXIDINE GLUCONATE
AT HI TECH PHARMA 0.12% A074356 001 May 07, 1996
AT LYNE 0.12% A074291 001 Dec 28, 1995
AT TEVA 0.12% A074522 001 Dec 15, 1995
AT WOCKHARDT 0.12% A075006 001 Mar 03, 2004
AT XTTRIUM 0.12% A077789 001 Jun 18, 2009
PAROEX
AT SUNSTAR AMERICAS 0.12% A076434 001 Nov 29, 2005
PERIDEX
AT + 3M 0.12% N019028 001 Aug 13, 1986
PERIOGARD
AT COLGATE 0.12% A073695 001 Jan 14, 1994
TABLET;DENTAL
PERIOCHIP
+ DEXCEL PHARMA 2.5MG N020774 001 May 15, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-76( of 362)
CHLOROPROCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CHLOROPROCAINE HYDROCHLORIDE
AP BEDFORD 2% A040273 001 Sep 09, 1998
AP 3% A040273 002 Sep 09, 1998
AP HOSPIRA 2% A087447 001 Apr 16, 1982
AP 3% A087446 001 Apr 16, 1982
NESACAINE
AP FRESENIUS KABI USA 2% N009435 002
NESACAINE-MPF
AP + FRESENIUS KABI USA 2% N009435 006 May 02, 1996
AP + 3% N009435 007 May 02, 1996
NESACAINE
+ FRESENIUS KABI USA 1% N009435 001
CHLOROQUINE PHOSPHATE
TABLET;ORAL
ARALEN
AA + SANOFI AVENTIS US EQ 300MG BASE N006002 001
CHLOROQUINE PHOSPHATE
AA IMPAX LABS EQ 150MG BASE A080880 001
AA EQ 300MG BASE A040516 001 Aug 29, 2003
AA IPCA LABS LTD EQ 150MG BASE A090610 001 Dec 03, 2009
AA EQ 300MG BASE A090249 001 Dec 03, 2009
AA NATCO PHARMA LTD EQ 150MG BASE A091621 001 Jan 21, 2011
AA EQ 300MG BASE A090612 001 Jan 21, 2011
AA + WEST WARD EQ 150MG BASE A083082 001
AA EQ 300MG BASE A083082 002 Sep 17, 1999
CHLOROTHIAZIDE
SUSPENSION;ORAL
DIURIL
+ SALIX PHARMS 250MG/5ML N011870 001
TABLET;ORAL
CHLOROTHIAZIDE
+ MYLAN 250MG A084388 001
500MG A084217 001
CHLOROTHIAZIDE SODIUM
INJECTABLE;INJECTION
CHLOROTHIAZIDE SODIUM
AP FRESENIUS KABI USA EQ 500MG BASE/VIAL A090896 001 Oct 16, 2009
AP LUITPOLD EQ 500MG BASE/VIAL A202561 001 Apr 22, 2013
AP SUN PHARMA GLOBAL EQ 500MG BASE/VIAL A091546 001 Jul 26, 2011
DIURIL
AP + OAK PHARMS AKORN EQ 500MG BASE/VIAL N011145 005
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE
SOLUTION;ORAL
VITUZ
+ CYPRESS PHARM 4MG/5ML;5MG/5ML N204307 001 Feb 20, 2013
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
SOLUTION;ORAL
ZUTRIPRO
+ CYPRESS PHARM 4MG/5ML;5MG/5ML;60MG/5ML N022439 001 Jun 08, 2011
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
CAPSULE, EXTENDED RELEASE;ORAL
TUSSICAPS
HI TECH PHARMA CO EQ 4MG MALEATE;EQ 5MG BITARTRATE A077273 002 Sep 24, 2007
+ EQ 8MG MALEATE;EQ 10MG BITARTRATE A077273 001 Sep 24, 2007
SUSPENSION, EXTENDED RELEASE;ORAL
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
AB TRIS PHARMA INC EQ 8MG MALEATE/5ML;EQ 10MG A091632 001 Oct 01, 2010
BITARTRATE/5ML
HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX
AB CORNERSTONE THERAP EQ 8MG MALEATE/5ML;EQ 10MG A091671 001 Jun 29, 2012
BITARTRATE/5ML
TUSSIONEX PENNKINETIC
AB + UCB INC EQ 8MG MALEATE/5ML;EQ 10MG N019111 001 Dec 31, 1987
BITARTRATE/5ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-77( of 362)
CHLORPROMAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
CHLORPROMAZINE HYDROCHLORIDE
+ HIKMA MAPLE 25MG/ML A083329 001
TABLET;ORAL
CHLORPROMAZINE HYDROCHLORIDE
BP SANDOZ 10MG A080439 001
BP 25MG A080439 002
BP 50MG A080439 003
BP + 100MG A080439 004
BP 200MG A080439 005
BP USL PHARMA 10MG A083386 001
BP 25MG A084112 001
BP 50MG A084113 001
BP 100MG A084114 001
BP 200MG A084115 001
CHLORPROPAMIDE
TABLET;ORAL
CHLORPROPAMIDE
AB MYLAN 100MG A088549 002 Jun 01, 1984
AB 250MG A088549 001 Jun 01, 1984
AB PLIVA 100MG A088921 001 Apr 12, 1985
AB 250MG A088922 001 Apr 12, 1985
DIABINESE
AB PFIZER 100MG N011641 003
AB + 250MG N011641 006
CHLORTHALIDONE
TABLET;ORAL
CHLORTHALIDONE
MYLAN 25MG A086831 002
+ 50MG A086831 001
THALITONE
+ CITRON PHARMA LLC 15MG N019574 001 Dec 20, 1988
CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE
TABLET;ORAL
CLORPRES
MYLAN 15MG;0.1MG A071325 003 Feb 09, 1987
15MG;0.2MG A071325 002 Feb 09, 1987
+ 15MG;0.3MG A071325 001 Feb 09, 1987
CHLORZOXAZONE
TABLET;ORAL
CHLORZOXAZONE
AA BARR 500MG A089895 001 May 04, 1988
AA WATSON LABS 500MG A040137 001 Aug 09, 1996
AA 500MG A081040 001 Aug 22, 1989
AA 500MG A089859 001 May 04, 1988
PARAFON FORTE DSC
AA + JANSSEN R AND D 500MG N011529 002 Jun 15, 1987
CHLORZOXAZONE
MIKART 375MG A040861 001 Jun 01, 2010
750MG A040861 002 Jun 01, 2010
CHOLESTYRAMINE
POWDER;ORAL
CHOLESTYRAMINE
AB PAR PHARM EQ 4GM RESIN/PACKET A077204 001 Aug 26, 2005
AB EQ 4GM RESIN/SCOOPFUL A077204 002 Aug 26, 2005
AB + SANDOZ EQ 4GM RESIN/PACKET A074557 001 Aug 15, 1996
AB EQ 4GM RESIN/SCOOPFUL A074557 002 Aug 15, 1996
CHOLESTYRAMINE LIGHT
AB PAR PHARM EQ 4GM RESIN/PACKET A077203 001 Aug 26, 2005
AB EQ 4GM RESIN/SCOOPFUL A077203 002 Aug 26, 2005
AB + SANDOZ EQ 4GM RESIN/PACKET A074558 001 Aug 15, 1996
AB EQ 4GM RESIN/SCOOPFUL A074558 002 Aug 15, 1996
PREVALITE
AB UPSHER SMITH EQ 4GM RESIN/PACKET A073263 001 Feb 22, 1996
AB EQ 4GM RESIN/SCOOPFUL A073263 002 Oct 30, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-78( of 362)
CHOLINE C-11
INJECTABLE;INTRAVENOUS
CHOLINE C-11
+ MCPRF 4-33.1mCi/ML N203155 001 Sep 12, 2012
CHOLINE FENOFIBRATE
CAPSULE, DELAYED RELEASE;ORAL
FENOFIBRIC ACID
AB ANCHEN PHARMS EQ 45MG FENOFIBRIC ACID A201573 002 Jul 18, 2013
AB EQ 135MG FENOFIBRIC ACID A201573 001 Jul 18, 2013
AB LUPIN LTD EQ 45MG FENOFIBRIC ACID A200750 001 Dec 04, 2013
AB EQ 135MG FENOFIBRIC ACID A200750 002 Dec 04, 2013
AB MYLAN PHARMS INC EQ 45MG FENOFIBRIC ACID A200913 001 Mar 25, 2013
AB EQ 135MG FENOFIBRIC ACID A200913 002 Mar 25, 2013
TRILIPIX
AB ABBVIE EQ 45MG FENOFIBRIC ACID N022224 001 Dec 15, 2008
AB + EQ 135MG FENOFIBRIC ACID N022224 002 Dec 15, 2008
CHORIOGONADOTROPIN ALFA
INJECTABLE;SUBCUTANEOUS
OVIDREL
+ EMD SERONO EQ 0.25MG /0.5ML N021149 002 Oct 06, 2003
CHROMIC CHLORIDE
INJECTABLE;INJECTION
CHROMIC CHLORIDE IN PLASTIC CONTAINER
+ HOSPIRA EQ 0.004MG CHROMIUM/ML N018961 001 Jun 26, 1986
CICLESONIDE
AEROSOL, METERED;INHALATION
ALVESCO
TAKEDA GMBH 0.08MG/INH N021658 002 Jan 10, 2008
+ 0.16MG/INH N021658 003 Jan 10, 2008
AEROSOL, METERED;NASAL
ZETONNA
+ TAKEDA GMBH 0.037MG/INH N202129 001 Jan 20, 2012
SPRAY, METERED;NASAL
OMNARIS
+ TAKEDA GMBH 0.05MG/INH N022004 001 Oct 20, 2006
CICLOPIROX
CREAM;TOPICAL
CICLOPIROX
AB FOUGERA PHARMS 0.77% A076435 001 Dec 29, 2004
AB G AND W LABS INC 0.77% A078463 001 Dec 20, 2010
AB GLENMARK PHARMS 0.77% A090273 001 Nov 10, 2009
AB PERRIGO 0.77% A077364 001 Mar 03, 2006
AB TARO 0.77% A076790 001 Apr 12, 2005
LOPROX
AB + MEDIMETRIKS PHARMS 0.77% N018748 001 Dec 30, 1982
GEL;TOPICAL
CICLOPIROX
AB FOUGERA PHARMS 0.77% A077896 001 Jun 10, 2008
AB GLENMARK GENERICS 0.77% A091595 001 Feb 29, 2012
AB PADDOCK LLC 0.77% A078266 001 Jan 07, 2009
LOPROX
AB + MEDICIS 0.77% N020519 001 Jul 21, 1997
SHAMPOO;TOPICAL
CICLOPIROX
AT FOUGERA PHARMS 1% A090146 001 May 25, 2010
AT PERRIGO 1% A078594 001 Feb 16, 2010
AT TARO 1% A090269 001 Feb 23, 2011
AT WATSON LABS INC 1% A090490 001 Nov 24, 2009
LOPROX
AT + MEDICIS 1% N021159 001 Feb 28, 2003
SOLUTION;TOPICAL
CICLOPIROX
AT ACTAVIS MID ATLANTIC 8% A078046 001 Sep 18, 2007
AT CIPLA LTD 8% A078124 001 Sep 18, 2007
AT G AND W LABS 8% A078233 001 Sep 18, 2007
AT HI TECH PHARMA 8% A078270 001 Sep 18, 2007
AT PERRIGO NEW YORK 8% A077623 001 Sep 18, 2007
AT TARO PHARM INDS 8% A078144 001 Sep 18, 2007
AT TOLMAR 8% A077687 001 Sep 18, 2007
AT VERSAPHARM 8% A078975 001 Feb 17, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-79( of 362)
CICLOPIROX
SOLUTION;TOPICAL
PENLAC
AT + VALEANT BERMUDA 8% N021022 001 Dec 17, 1999
SUSPENSION;TOPICAL
CICLOPIROX
AB FOUGERA PHARMS 0.77% A076422 001 Aug 06, 2004
AB PERRIGO NEW YORK 0.77% A077676 001 Dec 15, 2006
AB TARO 0.77% A077092 001 Aug 10, 2005
LOPROX
AB + MEDIMETRIKS PHARMS 0.77% N019824 001 Dec 30, 1988
CIDOFOVIR
INJECTABLE;INJECTION
CIDOFOVIR
AP EMCURE PHARMS LTD EQ 75MG BASE/ML A202501 001 Jul 26, 2012
AP MYLAN INSTITUTIONAL EQ 75MG BASE/ML A201276 001 Jun 27, 2012
VISTIDE
AP + GILEAD SCIENCES INC EQ 75MG BASE/ML N020638 001 Jun 26, 1996
CILASTATIN SODIUM; IMIPENEM
INJECTABLE;INJECTION
IMIPENEM AND CILASTATIN
AP ACS DOBFAR EQ 250MG BASE/VIAL;250MG/VIAL A090577 001 Dec 21, 2011
AP EQ 500MG BASE/VIAL;500MG/VIAL A090577 002 Dec 21, 2011
AP HOSPIRA INC EQ 250MG BASE/VIAL;250MG/VIAL A090825 001 Nov 16, 2011
AP EQ 500MG BASE/VIAL;500MG/VIAL A090825 002 Nov 16, 2011
AP EQ 500MG BASE/VIAL;500MG/VIAL A091007 001 Nov 16, 2011
PRIMAXIN
AP MERCK EQ 250MG BASE/VIAL;250MG/VIAL A062756 001 Jan 08, 1987
AP + EQ 250MG BASE/VIAL;250MG/VIAL N050587 001 Nov 26, 1985
AP EQ 500MG BASE/VIAL;500MG/VIAL A062756 002 Jan 08, 1987
AP + EQ 500MG BASE/VIAL;500MG/VIAL N050587 002 Nov 26, 1985
AP EQ 500MG BASE/VIAL;500MG/VIAL N050630 001 Dec 14, 1990
CILOSTAZOL
TABLET;ORAL
CILOSTAZOL
AB APOTEX INC 50MG A077030 001 Dec 10, 2004
AB 100MG A077030 002 Dec 10, 2004
AB BIOKEY 50MG A077722 001 Sep 24, 2012
AB 100MG A077831 001 Sep 24, 2012
AB BRECKENRIDGE PHARM 50MG A077708 001 Sep 28, 2009
AB 100MG A077708 002 Sep 28, 2009
AB MYLAN 50MG A077323 002 Apr 20, 2006
AB 100MG A077323 001 Apr 20, 2006
AB MYLAN PHARMS INC 50MG A077019 001 Nov 23, 2004
AB 100MG A077019 002 Nov 23, 2004
AB PLIVA HRVATSKA DOO 50MG A077898 001 Oct 29, 2007
AB 100MG A077898 002 Oct 29, 2007
AB ROXANE 50MG A077024 001 May 17, 2005
AB 100MG A077024 002 May 17, 2005
AB SANDOZ 50MG A077310 001 Nov 08, 2005
AB 100MG A077021 001 Nov 23, 2004
AB TEVA 50MG A077027 001 Nov 24, 2004
AB 100MG A077027 002 Nov 24, 2004
PLETAL
AB + OTSUKA 50MG N020863 001 Jan 15, 1999
AB + 100MG N020863 002 Jan 15, 1999
CIMETIDINE
TABLET;ORAL
CIMETIDINE
AB APOTEX 200MG A074890 001 Dec 18, 1998
AB 300MG A074890 002 Dec 18, 1998
AB 400MG A074890 003 Dec 18, 1998
AB 800MG A074890 004 Dec 18, 1998
AB DAVA PHARMS INC 300MG A074340 001 Jun 23, 1995
AB 400MG A074340 002 Jun 23, 1995
AB 800MG A074339 001 Jun 23, 1995
AB IVAX SUB TEVA PHARMS 200MG A074424 001 Jul 28, 1995
AB 300MG A074424 002 Jul 28, 1995
AB 400MG A074424 003 Jul 28, 1995
AB 800MG A074424 004 Jul 28, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
CIMETIDINE
TABLET;ORAL
CIMETIDINE
AB MYLAN
AB
AB
AB
AB PLIVA
AB
AB
AB
AB TEVA
AB
AB
AB
TAGAMET
AB GLAXOSMITHKLINE
AB
AB
AB +
CIMETIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
AP + BAYER HLTHCARE
AP +
CIPROFLOXACIN
AP CLARIS LIFESCIENCES
AP
AP HIKMA FARMACEUTICA
AP
AP HOSPIRA
AP
PRESCRIPTION DRUG PRODUCT LIST
200MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
200MG/100ML
400MG/200ML
200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
AP ACS DOBFAR INFO SA
AP
AP CLARIS LIFESCIENCES
AP
AP HIKMA FARMACEUTICA
AP HOSPIRA
AP
CIPROFLOXACIN HYDROCHLORIDE
OINTMENT;OPHTHALMIC
CILOXAN
+ ALCON PHARMS LTD
SOLUTION/DROPS;OPHTHALMIC
CILOXAN
AT + ALCON PHARMS LTD
200MG/100ML
400MG/200ML
200MG/100ML
400MG/200ML
400MG/200ML
200MG/100ML
400MG/200ML
EQ 0.3% BASE
EQ 0.3% BASE
3-80( of 362)
A074246 001 May 17, 1994
A074246 002 May 17, 1994
A074246 003 May 17, 1994
A074246 004 May 17, 1994
A074568 001 Feb 27, 1997
A074568 002 Feb 27, 1997
A074568 003 Feb 27, 1997
A074566 001 Feb 27, 1997
A074151 001 May 17, 1994
A074151 002 May 17, 1994
A074151 003 May 17, 1994
A074463 001 May 17, 1994
N017920 002
N017920 003
N017920 004 Dec 14, 1983
N017920 005 Apr 30, 1986
A074428 001 Apr 25, 1996
A074664 001 Oct 28, 1997
A074553 001 Jan 27, 1997
A074610 001 Sep 26, 1996
A074757 001 Oct 17, 1997
N021688 001 Mar 08, 2004
N021688 002 Mar 08, 2004
N021688 003 Mar 08, 2004
N020780 001 Sep 26, 1997
N020780 002 Sep 26, 1997
N019847 001 Dec 26, 1990
N019847 002 Dec 26, 1990
N019857 001 Dec 26, 1990
N019857 002 Dec 26, 1990
A078062 001 Apr 29, 2008
A078062 002 Apr 29, 2008
A076717 001 Dec 22, 2009
A076717 002 Dec 22, 2009
A077245 001 Aug 28, 2006
A077245 002 Aug 28, 2006
A078252 001 Mar 18, 2008
A078252 002 Mar 18, 2008
A078024 001 Mar 18, 2008
A078024 002 Mar 18, 2008
A078431 001 Nov 18, 2009
A077753 001 Mar 18, 2008
A077753 002 Mar 18, 2008
N020369 001 Mar 30, 1998
N019992 001 Dec 31, 1990
CIMETIDINE HYDROCHLORIDE
AP DAVA PHARMS INC
SOLUTION;ORAL
CIMETIDINE HYDROCHLORIDE
AA + HI TECH PHARMA
AA PHARM ASSOC
AA TEVA
AA WOCKHARDT
CINACALCET HYDROCHLORIDE
TABLET;ORAL
SENSIPAR
AMGEN
+
CIPROFLOXACIN
FOR SUSPENSION;ORAL
CIPRO
BAYER HLTHCARE
+
INJECTABLE;INJECTION
CIPRO
AP + BAYER HLTHCARE
AP +
EQ 300MG BASE/2ML
EQ 300MG BASE/5ML
EQ 300MG BASE/5ML
EQ 300MG BASE/5ML
EQ 300MG BASE/5ML
EQ 30MG BASE
EQ 60MG BASE
EQ 90MG BASE
250MG/5ML
500MG/5ML
400MG/40ML (10MG/ML)
200MG/20ML (10MG/ML)
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-81( of 362)
CIPROFLOXACIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CIPROFLOXACIN HYDROCHLORIDE
AT AKORN INC EQ 0.3% BASE A076555 001 Dec 11, 2008
AT BAUSCH AND LOMB EQ 0.3% BASE A076754 001 Jun 09, 2004
AT FDC LTD EQ 0.3% BASE A077568 001 Jun 30, 2008
AT HITECH PHARMA EQ 0.3% BASE A076673 001 Jan 21, 2005
AT NEXUS PHARMS EQ 0.3% BASE A077689 001 Dec 13, 2006
AT PHARMAFORCE EQ 0.3% BASE A078598 001 Jan 16, 2008
SOLUTION/DROPS;OTIC
CETRAXAL
+ WRASER PHARMS EQ 0.2% BASE N021918 001 May 01, 2009
TABLET;ORAL
CIPRO
AB BAYER HLTHCARE EQ 100MG BASE N019537 001 Apr 08, 1996
AB EQ 250MG BASE N019537 002 Oct 22, 1987
AB + EQ 500MG BASE N019537 003 Oct 22, 1987
AB EQ 750MG BASE N019537 004 Oct 22, 1987
CIPROFLOXACIN HYDROCHLORIDE
AB APOTEX EQ 250MG BASE A076896 001 Nov 04, 2004
AB EQ 500MG BASE A076896 002 Nov 04, 2004
AB EQ 750MG BASE A076896 003 Nov 04, 2004
AB AUROBINDO PHARMA EQ 250MG BASE A077859 001 Apr 26, 2007
AB EQ 500MG BASE A077859 002 Apr 26, 2007
AB EQ 750MG BASE A077859 003 Apr 26, 2007
AB CARLSBAD EQ 250MG BASE A076126 002 Jun 09, 2004
AB EQ 500MG BASE A076126 003 Jun 09, 2004
AB EQ 750MG BASE A076126 004 Jun 09, 2004
AB DR REDDYS LABS LTD EQ 100MG BASE A075593 002 Jun 09, 2004
AB EQ 250MG BASE A075593 003 Jun 09, 2004
AB EQ 500MG BASE A075593 004 Jun 09, 2004
AB EQ 750MG BASE A075593 001 Jun 09, 2004
AB HIKMA EQ 250MG BASE A076558 002 Jun 09, 2004
AB EQ 500MG BASE A076558 003 Jun 09, 2004
AB EQ 750MG BASE A076558 004 Jun 09, 2004
AB IVAX SUB TEVA PHARMS EQ 250MG BASE A076089 002 Jun 09, 2004
AB EQ 500MG BASE A076089 003 Jun 09, 2004
AB EQ 750MG BASE A076089 004 Jun 09, 2004
AB MYLAN EQ 100MG BASE A075817 001 Jun 25, 2007
AB EQ 250MG BASE A075685 002 Jun 09, 2004
AB EQ 250MG BASE A075817 002 Jun 09, 2004
AB EQ 500MG BASE A075685 003 Jun 09, 2004
AB EQ 500MG BASE A075817 003 Jun 09, 2004
AB EQ 750MG BASE A075685 001 Jun 09, 2004
AB EQ 750MG BASE A075817 004 Jun 09, 2004
AB RANBAXY EQ 250MG BASE A075747 001 Jun 09, 2004
AB EQ 500MG BASE A075747 002 Jun 09, 2004
AB EQ 750MG BASE A075747 003 Jun 09, 2004
AB TARO EQ 100MG BASE A076912 001 Feb 18, 2005
AB EQ 250MG BASE A076912 002 Oct 06, 2004
AB EQ 500MG BASE A076912 003 Oct 06, 2004
AB EQ 750MG BASE A076912 004 Oct 06, 2004
AB UNIQUE PHARM LABS EQ 250MG BASE A076639 001 Sep 10, 2004
AB EQ 500MG BASE A076639 002 Sep 10, 2004
AB EQ 750MG BASE A076639 003 Sep 10, 2004
AB WATSON LABS EQ 100MG BASE A076794 001 Feb 10, 2005
AB EQ 250MG BASE A076794 002 Jun 09, 2004
AB EQ 500MG BASE A076794 003 Jun 09, 2004
AB EQ 750MG BASE A076794 004 Jun 09, 2004
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
SUSPENSION/DROPS;OTIC
CIPRO HC
+ ALCON PHARMS LTD EQ 0.2% BASE;1% N020805 001 Feb 10, 1998
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CIPROFLOXACIN EXTENDED RELEASE
AB ANCHEN PHARMS 212.6MG;EQ 287.5MG BASE A078166 002 Nov 27, 2007
AB 425.2MG;EQ 574.9MG BASE A078166 001 Nov 27, 2007
AB DR REDDYS LABS LTD 425.2MG;EQ 574.9MG BASE A077701 001 Mar 26, 2007
AB + MYLAN PHARMS INC 212.6MG;EQ 287.5MG BASE A078183 001 Mar 22, 2007
AB + 425.2MG;EQ 574.9MG BASE A078183 002 Mar 22, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-82( of 362)
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CIPROFLOXACIN EXTENDED RELEASE
AB WATSON LABS FLORIDA 212.6MG;EQ 287.5MG BASE A077417 001 Nov 30, 2010
AB 425.2MG;EQ 574.9MG BASE A077809 001 Nov 30, 2010
CIPROFLOXACIN; DEXAMETHASONE
SUSPENSION/DROPS;OTIC
CIPRODEX
+ ALCON PHARMS LTD 0.3%;0.1% N021537 001 Jul 18, 2003
CISATRACURIUM BESYLATE
INJECTABLE;INJECTION
CISATRACURIUM BESYLATE
AP SANDOZ INC EQ 2MG BASE/ML A200159 001 Feb 03, 2012
CISATRACURIUM BESYLATE PRESERVATIVE FREE
AP SANDOZ INC EQ 2MG BASE/ML A200154 001 Feb 03, 2012
AP EQ 10MG BASE/ML A200154 002 Feb 03, 2012
NIMBEX
AP + ABBVIE EQ 2MG BASE/ML N020551 001 Dec 15, 1995
NIMBEX PRESERVATIVE FREE
AP + ABBVIE EQ 2MG BASE/ML N020551 003 Dec 15, 1995
AP + EQ 10MG BASE/ML N020551 002 Dec 15, 1995
CISPLATIN
INJECTABLE;INJECTION
CISPLATIN
AP BEDFORD 1MG/ML A075036 001 Nov 07, 2000
AP + FRESENIUS KABI USA 1MG/ML A074735 001 Jul 16, 1999
AP HQ SPCLT PHARMA 1MG/ML N018057 004 Nov 08, 1988
AP ONCO THERAPIES LTD 1MG/ML A091062 001 Apr 18, 2012
AP PHARMACHEMIE 1MG/ML A074656 001 May 16, 2000
CITALOPRAM HYDROBROMIDE
CAPSULE;ORAL
CITALOPRAM HYDROBROMIDE
MYLAN PHARMS INC EQ 10MG BASE A077668 001 Feb 28, 2007
EQ 20MG BASE A077668 002 Feb 28, 2007
+ EQ 40MG BASE A077668 003 Feb 28, 2007
SOLUTION;ORAL
CITALOPRAM HYDROBROMIDE
AA AUROBINDO PHARMA LTD EQ 10MG BASE/5ML A077812 001 Aug 28, 2006
AA + ROXANE EQ 10MG BASE/5ML A077043 001 Dec 13, 2004
AA SILARX EQ 10MG BASE/5ML A077629 001 Jun 15, 2006
TABLET;ORAL
CELEXA
AB FOREST LABS EQ 10MG BASE N020822 001 Apr 27, 2000
AB EQ 20MG BASE N020822 002 Jul 17, 1998
AB + EQ 40MG BASE N020822 003 Jul 17, 1998
CITALOPRAM HYDROBROMIDE
AB AMNEAL PHARMS NY EQ 10MG BASE A077289 001 Nov 30, 2006
AB EQ 20MG BASE A077289 002 Nov 30, 2006
AB EQ 40MG BASE A077289 003 Nov 30, 2006
AB APOTEX INC EQ 10MG BASE A077046 001 Nov 24, 2004
AB EQ 20MG BASE A077046 002 Nov 24, 2004
AB EQ 40MG BASE A077046 003 Nov 24, 2004
AB AUROBINDO EQ 10MG BASE A077031 001 Oct 28, 2004
AB EQ 20MG BASE A077031 002 Oct 28, 2004
AB EQ 40MG BASE A077031 003 Oct 28, 2004
AB CARACO EQ 10MG BASE A077032 001 Nov 12, 2004
AB EQ 20MG BASE A077032 002 Nov 12, 2004
AB EQ 40MG BASE A077032 003 Nov 12, 2004
AB CIPLA LTD EQ 10MG BASE A077044 001 Nov 05, 2004
AB EQ 20MG BASE A077044 002 Nov 05, 2004
AB EQ 40MG BASE A077044 003 Nov 05, 2004
AB DR REDDYS LABS LTD EQ 10MG BASE A077038 001 Oct 28, 2004
AB EQ 20MG BASE A077038 002 Oct 28, 2004
AB EQ 40MG BASE A077038 003 Oct 28, 2004
AB EPIC PHARMA EQ 10MG BASE A077045 003 Apr 29, 2005
AB EQ 20MG BASE A077045 002 Apr 29, 2005
AB EQ 40MG BASE A077045 001 Apr 29, 2005
AB GLENMARK GENERICS EQ 10MG BASE A077654 001 Feb 27, 2009
AB EQ 20MG BASE A077654 002 Feb 27, 2009
AB EQ 40MG BASE A077654 003 Feb 27, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-83( of 362)
CITALOPRAM HYDROBROMIDE
TABLET;ORAL
CITALOPRAM HYDROBROMIDE
AB INVAGEN PHARMS EQ 10MG BASE A077534 001 Oct 03, 2006
AB EQ 20MG BASE A077534 002 Oct 03, 2006
AB EQ 40MG BASE A077534 003 Oct 03, 2006
AB MYLAN EQ 10MG BASE A077039 001 Feb 03, 2005
AB EQ 10MG BASE A077042 001 Nov 05, 2004
AB EQ 20MG BASE A077039 002 Feb 03, 2005
AB EQ 20MG BASE A077042 002 Nov 05, 2004
AB EQ 40MG BASE A077039 003 Feb 03, 2005
AB EQ 40MG BASE A077042 003 Nov 05, 2004
AB MYLAN PHARMS INC EQ 10MG BASE A077037 001 Nov 05, 2004
AB EQ 20MG BASE A077037 002 Nov 05, 2004
AB EQ 40MG BASE A077037 003 Nov 05, 2004
AB PLIVA EQ 10MG BASE A077232 001 Oct 31, 2005
AB EQ 20MG BASE A077232 002 Oct 31, 2005
AB EQ 40MG BASE A077232 003 Oct 31, 2005
AB TEVA PHARMS EQ 10MG BASE A077048 001 Nov 16, 2004
AB EQ 20MG BASE A077048 002 Nov 16, 2004
AB EQ 40MG BASE A077048 003 Nov 16, 2004
AB TORRENT PHARMS EQ 10MG BASE A078216 001 Mar 27, 2007
AB EQ 20MG BASE A078216 002 Mar 27, 2007
AB EQ 40MG BASE A078216 003 Mar 27, 2007
AB WATSON LABS EQ 10MG BASE A077034 001 Jun 30, 2005
AB EQ 20MG BASE A077034 002 Jun 30, 2005
AB EQ 40MG BASE A077034 003 Jun 30, 2005
CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE
SOLUTION;IRRIGATION
RENACIDIN
+ UNITED GUARDIAN 6.602GM/100ML;198MG/100ML;3.177GM/100ML N019481 001 Oct 02, 1990
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
FOR SOLUTION;ORAL
PREPOPIK
+ FERRING PHARMS AS 12GM/PACKET;3.5GM/PACKET;10MG/PACKET N202535 001 Jul 16, 2012
CITRIC ACID; UREA C-13
FOR SOLUTION, TABLET, FOR SOLUTION;ORAL
IDKIT:HP
+ EXALENZ BIOSCIENCE N/A,4GM;75MG,N/A N021314 001 Dec 17, 2002
CLADRIBINE
INJECTABLE;INJECTION
CLADRIBINE
AP BEDFORD 1MG/ML A075405 001 Feb 28, 2000
AP + FRESENIUS KABI USA 1MG/ML A076571 001 Apr 22, 2004
AP ONCO THERAPIES LTD 1MG/ML A200510 001 Oct 06, 2011
CLARITHROMYCIN
FOR SUSPENSION;ORAL
BIAXIN
AB ABBVIE 125MG/5ML N050698 001 Dec 23, 1993
AB + 250MG/5ML N050698 002 Dec 23, 1993
CLARITHROMYCIN
AB RANBAXY 125MG/5ML A065382 001 Aug 30, 2007
AB 250MG/5ML A065382 002 Aug 30, 2007
AB SANDOZ 125MG/5ML A065283 002 Sep 04, 2007
AB 250MG/5ML A065283 003 Sep 04, 2007
TABLET;ORAL
BIAXIN
AB + ABBVIE 250MG N050662 001 Oct 31, 1991
AB + 500MG N050662 002 Oct 31, 1991
CLARITHROMYCIN
AB ALLIED PHARMA INC 250MG A202710 001 Jun 10, 2013
AB 500MG A202710 002 Jun 10, 2013
AB APOTEX CORP 250MG A065384 001 Aug 20, 2007
AB 500MG A065384 002 Aug 20, 2007
AB AUROBINDO 250MG A065489 001 Jul 25, 2012
AB 500MG A065489 002 Jul 25, 2012
AB MYLAN 250MG A065195 001 Mar 11, 2005
AB 500MG A065195 002 Mar 11, 2005
AB RANBAXY 250MG A065174 001 Sep 24, 2004
AB 500MG A065174 002 Sep 24, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-84( of 362)
CLARITHROMYCIN
TABLET;ORAL
CLARITHROMYCIN
AB ROXANE 250MG A065178 002 May 25, 2004
AB 500MG A065178 001 May 25, 2004
AB SANDOZ 250MG A065144 001 Oct 18, 2005
AB 500MG A065136 001 Aug 25, 2005
AB TEVA 250MG A065155 001 May 31, 2005
AB 500MG A065155 002 May 31, 2005
AB WOCKHARDT 250MG A065266 001 May 31, 2006
AB 500MG A065266 002 May 31, 2006
TABLET, EXTENDED RELEASE;ORAL
BIAXIN XL
AB + ABBVIE 500MG N050775 001 Mar 03, 2000
CLARITHROMYCIN
AB TEVA 500MG A065154 001 May 18, 2005
AB WATSON LABS FLORIDA 500MG A065145 001 Jun 24, 2004
CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM
INJECTABLE;INJECTION
TIMENTIN
+ GLAXOSMITHKLINE EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL N050590 003 Aug 18, 1987
EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL A062691 001 Dec 19, 1986
+ EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL N050590 001 Apr 01, 1985
+ EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL N050590 002 Apr 01, 1985
TIMENTIN IN PLASTIC CONTAINER
+ GLAXOSMITHKLINE EQ 100MG BASE/100ML;EQ 3GM BASE/100ML N050658 001 Dec 15, 1989
CLEMASTINE FUMARATE
SYRUP;ORAL
CLEMASTINE FUMARATE
AA + TEVA EQ 0.5MG BASE/5ML A073399 001 Jun 30, 1994
AA WOCKHARDT EQ 0.5MG BASE/5ML A074863 001 Mar 13, 1998
TABLET;ORAL
CLEMASTINE FUMARATE
AB SANDOZ 2.68MG A073459 001 Oct 31, 1993
AB + TEVA 2.68MG A073283 001 Jan 31, 1992
CLEVIDIPINE
EMULSION;INTRAVENOUS
CLEVIPREX
+ MEDICINES CO 25MG/50ML (0.5MG/ML) N022156 001 Aug 01, 2008
+ 50MG/100ML (0.5MG/ML) N022156 002 Aug 01, 2008
+ 125MG/250ML (0.5MG/ML) N022156 003 Nov 08, 2013
CLINDAMYCIN HYDROCHLORIDE
CAPSULE;ORAL
CLEOCIN HYDROCHLORIDE
AB PHARMACIA AND UPJOHN EQ 75MG BASE N050162 001
AB EQ 150MG BASE N050162 002
AB + EQ 300MG BASE N050162 003 Apr 14, 1988
CLINDAMYCIN HYDROCHLORIDE
AB AUROBINDO PHARMA EQ 150MG BASE A065442 001 Aug 26, 2009
AB EQ 300MG BASE A065442 002 Aug 26, 2009
AB COREPHARMA EQ 150MG BASE A065194 001 Mar 22, 2004
AB EQ 300MG BASE A065194 002 Mar 22, 2004
AB LANNETT EQ 75MG BASE A065242 001 Aug 12, 2005
AB EQ 150MG BASE A065242 002 Aug 12, 2005
AB EQ 300MG BASE A065243 001 Aug 12, 2005
AB MYLAN PHARMS INC EQ 75MG BASE A091225 001 May 31, 2011
AB EQ 150MG BASE A091225 002 May 31, 2011
AB EQ 300MG BASE A091225 003 May 31, 2011
AB RANBAXY EQ 150MG BASE A065061 001 Feb 02, 2001
AB EQ 300MG BASE A065061 002 Feb 02, 2001
AB TEVA EQ 150MG BASE A063029 001 Sep 20, 1989
AB EQ 300MG BASE A063029 002 Aug 05, 2005
AB WATSON LABS EQ 150MG BASE A063083 001 Jul 31, 1991
AB EQ 300MG BASE A063083 002 Mar 18, 2003
AB ZYDUS PHARMS USA EQ 75MG BASE A065217 001 Jan 31, 2005
AB EQ 150MG BASE A065217 002 Jan 31, 2005
AB EQ 300MG BASE A065217 003 Jan 31, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-85( of 362)
CLINDAMYCIN PALMITATE HYDROCHLORIDE
FOR SOLUTION;ORAL
CLEOCIN
AA + PHARMACIA AND UPJOHN EQ 75MG BASE/5ML A062644 001 Apr 07, 1986
CLINDAMYCIN PALMITATE HYDROCHLORIDE
AA AUROBINDO PHARMA LTD EQ 75MG BASE/5ML A202409 001 Apr 30, 2013
AA LYNE EQ 75MG BASE/5ML A201821 001 Aug 28, 2012
AA PADDOCK LABS EQ 75MG BASE/5ML A090902 001 Jul 07, 2010
CLINDAMYCIN PHOSPHATE
AEROSOL, FOAM;TOPICAL
CLINDAMYCIN PHOSPHATE
AT PERRIGO UK FINCO 1% A090785 001 Mar 31, 2010
EVOCLIN
AT + DELCOR ASSET 1% N050801 001 Oct 22, 2004
CREAM;VAGINAL
CLEOCIN
AB + PHARMACIA AND UPJOHN EQ 2% BASE N050680 002 Mar 02, 1998
CLINDAMYCIN PHOSPHATE
AB FOUGERA PHARMS EQ 2% BASE A065139 001 Dec 27, 2004
CLINDESSE
+ KV PHARM EQ 2% BASE N050793 001 Nov 30, 2004
GEL;TOPICAL
CLEOCIN T
AB + PHARMACIA AND UPJOHN EQ 1% BASE N050615 001 Jan 07, 1987
CLINDAMYCIN PHOSPHATE
AB FOUGERA PHARMS EQ 1% BASE A064160 001 Jan 28, 2000
CLINDAGEL
BT + PRECISION DERMAT EQ 1% BASE N050782 001 Nov 27, 2000
INJECTABLE;INJECTION
CLEOCIN PHOSPHATE
AP PHARMACIA AND UPJOHN EQ 150MG BASE/ML A062803 001 Oct 16, 1987
AP + EQ 150MG BASE/ML N050441 001
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + PHARMACIA AND UPJOHN EQ 6MG BASE/ML N050639 001 Aug 30, 1989
AP + EQ 12MG BASE/ML N050639 002 Aug 30, 1989
AP + EQ 18MG BASE/ML N050639 003 Apr 10, 1991
CLINDAMYCIN PHOSPHATE
AP BEDFORD EQ 150MG BASE/ML A065206 001 Sep 24, 2004
AP FRESENIUS KABI USA EQ 150MG BASE/ML A065346 001 Mar 29, 2007
AP EQ 150MG BASE/ML A065347 001 May 09, 2007
AP HIKMA MAPLE EQ 150MG BASE/ML A062889 001 Apr 25, 1988
AP HOSPIRA EQ 150MG BASE/ML A062800 001 Jul 24, 1987
AP EQ 150MG BASE/ML A062801 001 Jul 24, 1987
AP EQ 150MG BASE/ML A062943 001 Sep 29, 1988
AP SAGENT STRIDES EQ 150MG BASE/ML A090108 001 Sep 30, 2011
AP EQ 150MG BASE/ML A090109 001 Sep 30, 2011
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
AP AKORN INC EQ 6MG BASE/ML A203048 001 Apr 04, 2013
AP EQ 12MG BASE/ML A203048 002 Apr 04, 2013
AP EQ 18MG BASE/ML A203048 003 Apr 04, 2013
AP SANDOZ INC EQ 6MG BASE/ML A201692 001 May 31, 2012
AP EQ 12MG BASE/ML A201692 002 May 31, 2012
AP EQ 18MG BASE/ML A201692 003 May 31, 2012
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
+ ABRAXIS PHARM EQ 900MG BASE/100ML N050635 001 Dec 22, 1989
LOTION;TOPICAL
CLEOCIN T
AB + PHARMACIA AND UPJOHN EQ 1% BASE N050600 001 May 31, 1989
CLINDAMYCIN PHOSPHATE
AB FOUGERA PHARMS EQ 1% BASE A065067 001 Jan 31, 2002
SOLUTION;TOPICAL
CLEOCIN T
AT + PHARMACIA AND UPJOHN EQ 1% BASE N050537 001
CLINDA-DERM
AT PADDOCK LLC EQ 1% BASE A063329 001 Sep 30, 1992
CLINDAMYCIN PHOSPHATE
AT FOUGERA EQ 1% BASE A064159 001 Jun 05, 1997
AT FOUGERA PHARMS EQ 1% BASE A065254 001 Feb 14, 2006
AT PERRIGO NEW YORK EQ 1% BASE A064050 001 Nov 30, 1995
AT TARO PHARM INDS EQ 1% BASE A065184 001 Mar 31, 2004
AT WOCKHARDT EQ 1% BASE A063304 001 Jul 15, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-86( of 362)
CLINDAMYCIN PHOSPHATE
SUPPOSITORY;VAGINAL
CLEOCIN
+ PHARMACIA AND UPJOHN 100MG N050767 001 Aug 13, 1999
SWAB;TOPICAL
CLEOCIN
AT PHARMACIA AND UPJOHN EQ 1% BASE N050537 002 Feb 22, 1994
CLINDAMYCIN PHOSPHATE
AT PERRIGO NEW YORK EQ 1% BASE A065049 001 May 25, 2000
AT VERSAPHARM EQ 1% BASE A065513 001 Jun 17, 2010
CLINDETS
AT PERRIGO EQ 1% BASE A064136 001 Sep 30, 1996
CLINDAMYCIN PHOSPHATE; TRETINOIN
GEL;TOPICAL
VELTIN
BX + STIEFEL GSK 1.2%;0.025% N050803 001 Jul 16, 2010
ZIANA
BX + MEDICIS 1.2%;0.025% N050802 001 Nov 07, 2006
CLOBAZAM
SUSPENSION;ORAL
ONFI
+ LUNDBECK LLC 2.5MG/ML N203993 001 Dec 14, 2012
TABLET;ORAL
ONFI
LUNDBECK LLC 10MG N202067 002 Oct 21, 2011
+ 20MG N202067 003 Oct 21, 2011
CLOBETASOL PROPIONATE
AEROSOL, FOAM;TOPICAL
CLOBETASOL PROPIONATE
AB1 PERRIGO ISRAEL 0.05% A077763 001 Mar 10, 2008
OLUX
AB1 + STIEFEL LABS INC 0.05% N021142 001 May 26, 2000
CLOBETASOL PROPIONATE
AB2 PERRIGO ISRAEL 0.05% A201402 001 Aug 14, 2012
OLUX E
AB2 + DELCOR ASSET 0.05% N022013 001 Jan 12, 2007
CREAM;TOPICAL
CLOBETASOL PROPIONATE
AB1 FOUGERA 0.05% A074392 001 Sep 30, 1996
AB1 TARO 0.05% A074249 001 Jul 08, 1996
CORMAX
AB1 HI TECH PHARMA 0.05% A074220 001 May 16, 1997
TEMOVATE
AB1 + FOUGERA PHARMS 0.05% N019322 001 Dec 27, 1985
CLOBETASOL PROPIONATE (EMOLLIENT)
AB2 FOUGERA PHARMS 0.05% A075430 001 May 26, 1999
AB2 TARO 0.05% A075633 001 May 17, 2000
EMBELINE E
AB2 HI TECH PHARMA 0.05% A075325 001 Dec 24, 1998
TEMOVATE E
AB2 + FOUGERA PHARMS 0.05% N020340 001 Jun 17, 1994
GEL;TOPICAL
CLOBETASOL PROPIONATE
AB FOUGERA PHARMS 0.05% A075368 001 Feb 15, 2000
AB PERRIGO 0.05% A075027 001 Oct 31, 1997
AB TARO 0.05% A075279 001 May 28, 1999
EMBELINE
AB HI TECH PHARMA 0.05% A076141 001 Apr 12, 2002
TEMOVATE
AB + FOUGERA PHARMS 0.05% N020337 001 Apr 29, 1994
LOTION;TOPICAL
CLOBETASOL PROPIONATE
AB ACTAVIS MID ATLANTIC 0.05% A078223 001 Dec 04, 2008
AB TARO 0.05% A200302 001 Jul 02, 2012
CLOBEX
AB + GALDERMA LABS LP 0.05% N021535 001 Jul 24, 2003
OINTMENT;TOPICAL
CLOBETASOL PROPIONATE
AB FOUGERA PHARMS 0.05% A074407 001 Feb 23, 1996
AB TARO 0.05% A074248 001 Jul 12, 1996
AB TEVA PHARMS 0.05% A074089 001 Feb 16, 1994
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
CLOBETASOL PROPIONATE
OINTMENT;TOPICAL
EMBELINE
AB HI TECH PHARMA
TEMOVATE
AB + FOUGERA PHARMS
SHAMPOO;TOPICAL
CLOBETASOL PROPIONATE
AB ACTAVIS MID ATLANTIC
AB PERRIGO ISRAEL
CLOBEX
AB + GALDERMA LABS
SOLUTION;TOPICAL
CLOBETASOL PROPIONATE
AT FOUGERA PHARMS
AT TARO
AT
AT TOLMAR
AT WOCKHARDT
EMBELINE
AT + HI TECH PHARMA
SPRAY;TOPICAL
CLOBETASOL PROPIONATE
AT PADDOCK LLC
CLOBEX
AT + GALDERMA LABS LP
CLOCORTOLONE PIVALATE
CREAM;TOPICAL
CLODERM
+ PROMIUS PHARMA LLC
CLOFARABINE
INJECTABLE;IV (INFUSION)
CLOLAR
+ GENZYME
CLOFAZIMINE
CAPSULE;ORAL
LAMPRENE
+ NOVARTIS
CLOMIPHENE CITRATE
TABLET;ORAL
CLOMID
AB + SANOFI AVENTIS US
CLOMIPHENE CITRATE
AB PAR PHARM
SEROPHENE
AB EMD SERONO
CLOMIPRAMINE HYDROCHLORIDE
CAPSULE;ORAL
ANAFRANIL
AB MALLINCKRODT LLC
AB +
AB
CLOMIPRAMINE HYDROCHLORIDE
AB MYLAN
AB
AB
AB SANDOZ
AB
AB
AB TARO
AB
AB
AB TEVA
AB
AB
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.1%
20MG/20ML (1MG/ML)
50MG
50MG
50MG
50MG
25MG
50MG
75MG
25MG
50MG
75MG
25MG
50MG
75MG
25MG
50MG
75MG
25MG
50MG
75MG
3-87( of 362)
A074221 001 Mar 31, 1995
N019323 001 Dec 27, 1985
A078854 001 Jun 07, 2011
A090974 001 Aug 09, 2012
N021644 001 Feb 05, 2004
A075391 001 Feb 08, 1999
A075224 001 Nov 16, 1998
A075363 001 Dec 29, 2000
A076977 001 Aug 05, 2005
A075205 001 Nov 13, 1998
A074222 001 Dec 06, 1995
A090898 001 Jun 16, 2011
N021835 001 Oct 27, 2005
N017765 001
N021673 001 Dec 28, 2004
N019500 002 Dec 15, 1986
N016131 002
A075528 001 Aug 30, 1999
N018361 001 Mar 22, 1982
N019906 001 Dec 29, 1989
N019906 002 Dec 29, 1989
N019906 003 Dec 29, 1989
A074947 001 Apr 30, 1998
A074947 002 Apr 30, 1998
A074947 003 Apr 30, 1998
A074364 001 Mar 29, 1996
A074364 002 Mar 29, 1996
A074364 003 Mar 29, 1996
A074694 001 Dec 31, 1996
A074694 002 Dec 31, 1996
A074694 003 Dec 31, 1996
A074958 001 Aug 26, 1997
A074958 002 Aug 26, 1997
A074958 003 Aug 26, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-88( of 362)
CLONAZEPAM
TABLET;ORAL
CLONAZEPAM
AB ACCORD HLTHCARE 0.5MG A077147 001 May 02, 2005
AB 1MG A077147 002 May 02, 2005
AB 2MG A077147 003 May 02, 2005
AB ACTAVIS ELIZABETH 0.5MG A074869 001 Oct 31, 1996
AB 1MG A074869 002 Oct 31, 1996
AB 2MG A074869 003 Oct 31, 1996
AB CARACO 0.5MG A075423 001 Apr 27, 2001
AB 1MG A075423 002 Apr 27, 2001
AB 2MG A075423 003 Apr 27, 2001
AB MYLAN 0.5MG A075150 001 Oct 05, 1998
AB 1MG A075150 002 Oct 05, 1998
AB 2MG A075150 003 Oct 05, 1998
AB MYLAN PHARMS INC 0.5MG A074940 001 Oct 30, 1997
AB 1MG A074940 002 Oct 30, 1997
AB 2MG A074940 003 Oct 30, 1997
AB SANDOZ 0.5MG A074979 001 Aug 29, 1997
AB 1MG A074979 002 Aug 29, 1997
AB 2MG A074979 003 Aug 29, 1997
AB TEVA 0.5MG A074569 001 Sep 10, 1996
AB 1MG A074569 002 Sep 10, 1996
AB 2MG A074569 003 Sep 10, 1996
AB VINTAGE PHARMS 0.5MG A077856 001 Jun 28, 2006
AB 1MG A077856 002 Jun 28, 2006
AB 2MG A077856 003 Jun 28, 2006
AB WATSON LABS 0.5MG A074964 001 Dec 30, 1997
AB 1MG A074964 002 Dec 30, 1997
AB 2MG A074964 003 Dec 30, 1997
KLONOPIN
AB ROCHE 0.5MG N017533 001
AB + 1MG N017533 002
AB 2MG N017533 003
TABLET, ORALLY DISINTEGRATING;ORAL
CLONAZEPAM
AB BARR 0.125MG A077194 001 Aug 10, 2005
AB 0.25MG A077194 002 Aug 10, 2005
AB 0.5MG A077194 003 Aug 10, 2005
AB 1MG A077194 004 Aug 10, 2005
AB 2MG A077194 005 Aug 10, 2005
AB PAR PHARM 0.125MG A077171 001 Aug 03, 2005
AB 0.25MG A077171 002 Aug 03, 2005
AB 0.5MG A077171 003 Aug 03, 2005
AB + 1MG A077171 004 Aug 03, 2005
AB 2MG A077171 005 Aug 03, 2005
CLONIDINE
FILM, EXTENDED RELEASE;TRANSDERMAL
CATAPRES-TTS-1
AB BOEHRINGER INGELHEIM 0.1MG/24HR N018891 001 Oct 10, 1984
CATAPRES-TTS-2
AB BOEHRINGER INGELHEIM 0.2MG/24HR N018891 002 Oct 10, 1984
CATAPRES-TTS-3
AB + BOEHRINGER INGELHEIM 0.3MG/24HR N018891 003 Oct 10, 1984
CLONIDINE
AB AVEVA 0.1MG/24HR A076157 001 Aug 18, 2009
AB 0.2MG/24HR A076157 002 Aug 18, 2009
AB 0.3MG/24HR A076157 003 Aug 18, 2009
AB BARR 0.1MG/24HR A079090 001 Aug 20, 2010
AB 0.2MG/24HR A079090 002 Aug 20, 2010
AB 0.3MG/24HR A079090 003 Aug 20, 2010
AB MYLAN TECHNOLOGIES 0.1MG/24HR A076166 001 Jul 16, 2010
AB 0.2MG/24HR A076166 002 Jul 16, 2010
AB 0.3MG/24HR A076166 003 Jul 16, 2010
CLONIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
CLONIDINE HYDROCHLORIDE
AP EXELA PHARMA SCS LLC 1MG/10ML (0.1MG/ML) A203167 001 Oct 29, 2013
AP 5MG/10ML (0.5MG/ML) A203167 002 Oct 29, 2013
AP FRESENIUS KABI USA 1MG/10ML (0.1MG/ML) A200673 001 Jul 08, 2011
AP 5MG/10ML (0.5MG/ML) A200673 002 Jul 08, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
CLONIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
CLONIDINE HYDROCHLORIDE
AP HIKMA FARMACEUTICA
AP
AP LUITPOLD
AP
DURACLON
AP MYLAN INSTITUTIONAL
AP +
TABLET;ORAL
CATAPRES
AB BOEHRINGER INGELHEIM
AB
AB +
CLONIDINE HYDROCHLORIDE
AB ACTAVIS ELIZABETH
AB
AB
AB ALEMBIC PHARMS LTD
AB
AB
AB CARLSBAD
AB
AB
AB DAVA PHARMS INC
AB
AB
AB IMPAX LABS
AB
AB
AB MUTUAL PHARM
AB
AB
AB MYLAN
AB
AB
AB UNICHEM
AB
AB
AB VINTAGE
AB
AB
AB WATSON LABS
TABLET, EXTENDED RELEASE;ORAL
CLONIDINE HYDROCHLORIDE
AB ANCHEN PHARMS
AB
KAPVAY
AB + CONCORDIA PHARMS INC
AB
CLOPIDOGREL BISULFATE
TABLET;ORAL
CLOPIDOGREL BISULFATE
AB ACCORD HLTHCARE
AB
AB ACTAVIS TOTOWA
AB APOTEX INC
AB AUROBINDO PHARMA LTD
AB DR REDDYS LABS INC
AB DR REDDYS LABS LTD
AB GATE PHARMS
AB MUTUAL PHARM
AB MYLAN PHARMS INC
AB
AB ROXANE
AB SUN PHARMA GLOBAL
AB TEVA
AB TEVA PHARMS
AB TORRENT PHARMS LTD
AB WOCKHARDT LTD
AB
1MG/10ML (0.1MG/ML)
5MG/10ML (0.5MG/ML)
1 MG/10 ML (0.1 MG/ML)
5 MG/10 ML (0.5 MG/ML)
1 MG/10 ML (0.1 MG/ML)
5 MG/10 ML (0.5 MG/ML)
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.3MG
0.1MG
0.2MG
0.1MG
0.2MG
EQ 75MG BASE
EQ 300MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 300MG BASE
EQ 300MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 300MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 300MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 300MG BASE
3-89( of 362)
A200300 001 Jan 26, 2011
A200300 002 Jan 26, 2011
A091104 001 Oct 08, 2009
A091104 002 Oct 08, 2009
N020615 001 Oct 02, 1996
N020615 002 Apr 27, 1999
N017407 001
N017407 002
N017407 003
A070974 001 Dec 16, 1986
A070975 001 Dec 16, 1986
A070976 001 Dec 16, 1986
A091368 001 Dec 06, 2011
A091368 002 Dec 06, 2011
A091368 003 Dec 06, 2011
A202297 001 Jun 13, 2013
A202297 002 Jun 13, 2013
A202297 003 Jun 13, 2013
A071783 001 Apr 05, 1988
A071784 001 Apr 05, 1988
A071785 001 Apr 05, 1988
A078099 001 Aug 27, 2009
A078099 002 Aug 27, 2009
A078099 003 Aug 27, 2009
A070925 001 Sep 04, 1987
A070924 001 Sep 04, 1987
A070923 001 Sep 04, 1987
A070317 002 Jul 09, 1987
A070317 003 Jun 09, 1987
A070317 001 Jun 09, 1987
A078895 001 Aug 26, 2009
A078895 002 Aug 26, 2009
A078895 003 Aug 26, 2009
A077901 001 Mar 09, 2007
A077901 002 Mar 09, 2007
A077901 003 Mar 09, 2007
A070963 001 Jul 08, 1986
A202984 001 Sep 30, 2013
A202984 002 Sep 30, 2013
N022331 003 Sep 28, 2010
N022331 004 Sep 28, 2010
A202925 001 Mar 27, 2013
A202925 002 Mar 27, 2013
A090307 001 May 28, 2013
A076274 001 May 17, 2012
A090540 001 May 17, 2012
A076273 001 Jan 14, 2008
A091023 001 May 17, 2012
A091216 001 May 17, 2012
A078133 001 Jun 10, 2013
A077665 001 May 17, 2012
A077665 002 May 17, 2012
A078004 001 May 17, 2012
A090494 001 May 17, 2012
A076999 001 May 17, 2012
A090625 001 May 17, 2012
A090844 001 May 17, 2012
A202266 001 Aug 14, 2012
A202266 002 Nov 20, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-90( of 362)
CLOPIDOGREL BISULFATE
TABLET;ORAL
CLOPIDOGREL BISULFATE
AB ZYDUS PHARMS USA INC EQ 75MG BASE A201686 001 Oct 10, 2012
PLAVIX
AB SANOFI AVENTIS US EQ 75MG BASE N020839 001 Nov 17, 1997
AB + EQ 300MG BASE N020839 002 Sep 20, 2007
CLORAZEPATE DIPOTASSIUM
TABLET;ORAL
CLORAZEPATE DIPOTASSIUM
AB MYLAN 3.75MG A071858 002 Jul 17, 1987
AB 7.5MG A071858 003 Jul 17, 1987
AB 15MG A071858 001 Jul 17, 1987
AB RANBAXY 3.75MG A076911 001 Sep 29, 2004
AB 7.5MG A076911 002 Sep 29, 2004
AB 15MG A076911 003 Sep 29, 2004
AB TARO 3.75MG A075731 003 Apr 27, 2000
AB 7.5MG A075731 002 Apr 27, 2000
AB 15MG A075731 001 Apr 27, 2000
AB WATSON LABS 3.75MG A071852 001 Feb 09, 1988
AB 7.5MG A071853 001 Feb 09, 1988
AB 15MG A071854 001 Feb 09, 1988
GEN-XENE
AB ALRA 3.75MG A071787 001 Apr 26, 1988
AB 7.5MG A071788 001 Apr 26, 1988
AB 15MG A071789 001 Apr 26, 1988
TRANXENE
AB RECORDATI RARE 3.75MG N017105 006
AB 7.5MG N017105 007
AB + 15MG N017105 008
CLOTRIMAZOLE
CREAM;TOPICAL
CLOTRIMAZOLE
AB FOUGERA PHARMS 1% A078338 001 Sep 02, 2008
AB GLENMARK PHARMS 1% A090219 001 Aug 03, 2010
AB + TARO 1% A072640 001 Aug 31, 1993
SOLUTION;TOPICAL
CLOTRIMAZOLE
AT + TARO 1% A074580 001 Jul 29, 1996
AT TEVA 1% A073306 001 Feb 28, 1995
TROCHE/LOZENGE;ORAL
CLOTRIMAZOLE
AB PADDOCK LLC 10MG A076763 001 Oct 28, 2005
AB + ROXANE 10MG A076387 001 Jul 29, 2004
CLOZAPINE
SUSPENSION;ORAL
VERSACLOZ
+ JAZZ PHARMS III 50MG/ML N203479 001 Feb 06, 2013
TABLET;ORAL
CLOZAPINE
AB CARACO 25MG A075713 001 Nov 15, 2002
AB 50MG A075713 003 Aug 19, 2005
AB 100MG A075713 002 Nov 15, 2002
AB IVAX SUB TEVA PHARMS 25MG A074949 001 Nov 26, 1997
AB 50MG A074949 004 Apr 25, 2005
AB 50MG A076809 003 Dec 16, 2005
AB 100MG A074949 002 Nov 26, 1997
AB 100MG A076809 002 Dec 16, 2005
AB MYLAN 25MG A075417 001 May 27, 1999
AB 100MG A075417 002 May 27, 1999
CLOZARIL
AB NOVARTIS 25MG N019758 001 Sep 26, 1989
AB + 100MG N019758 002 Sep 26, 1989
CLOZAPINE
IVAX SUB TEVA PHARMS 12.5MG A074949 003 Jul 31, 2003
200MG A076809 001 Dec 16, 2005
TABLET, ORALLY DISINTEGRATING;ORAL
FAZACLO ODT
+
JAZZ PHARMS III 12.5MG
25MG
100MG
N021590 004
N021590 001
N021590 002
May 30, 2007
Feb 10, 2004
Feb 10, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-91( of 362)
CLOZAPINE
TABLET, ORALLY DISINTEGRATING;ORAL
FAZACLO ODT
150MG N021590 005 Jul 09, 2010
200MG N021590 006 Jul 09, 2010
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
TABLET;ORAL
STRIBILD
+ GILEAD SCIENCES INC 150MG;150MG;200MG;300MG N203100 001 Aug 27, 2012
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
AA VINTAGE 10MG/5ML;5MG/5ML;6.25MG/5ML A040660 001 Dec 07, 2006
PROMETH VC W/ CODEINE
AA + ACTAVIS MID ATLANTIC 10MG/5ML;5MG/5ML;6.25MG/5ML A088764 001 Oct 31, 1984
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
AA + ACTAVIS MID ATLANTIC 10MG/5ML;6.25MG/5ML A088763 001 Oct 31, 1984
AA AMNEAL PHARMS 10MG/5ML;6.25MG/5ML A200894 001 Apr 24, 2013
AA CARACO 10MG/5ML;6.25MG/5ML A090180 001 Mar 17, 2010
AA HI TECH PHARMA 10MG/5ML;6.25MG/5ML A040151 001 Aug 26, 1997
AA TRIS PHARMA INC 10MG/5ML;6.25MG/5ML A200386 001 Jun 29, 2012
AA WOCKHARDT 10MG/5ML;6.25MG/5ML A088875 001 Dec 17, 1984
PROMETHAZINE WITH CODEINE
AA VINTAGE 10MG/5ML;6.25MG/5ML A040650 001 Jan 31, 2006
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
SYRUP;ORAL
TRIACIN-C
+ STI PHARMA LLC 10MG/5ML;30MG/5ML;1.25MG/5ML A088704 001 Mar 22, 1985
CODEINE SULFATE
SOLUTION;ORAL
CODEINE SULFATE
+ ROXANE 30MG/5ML N202245 001 Jun 30, 2011
TABLET;ORAL
CODEINE SULFATE
ROXANE 15MG N022402 001 Jul 16, 2009
30MG N022402 002 Jul 16, 2009
+ 60MG N022402 003 Jul 16, 2009
COLCHICINE
TABLET;ORAL
COLCRYS
+ TAKEDA PHARMS USA 0.6MG N022352 001 Jul 29, 2009
COLCHICINE; PROBENECID
TABLET;ORAL
COL-PROBENECID
AB + WATSON LABS 0.5MG;500MG A084279 001
PROBENECID AND COLCHICINE
AB MIRROR PHARMS 0.5MG;500MG A040618 001 May 13, 2008
COLESEVELAM HYDROCHLORIDE
FOR SUSPENSION;ORAL
WELCHOL
DAIICHI SANKYO 1.875GM/PACKET N022362 001 Oct 02, 2009
+ 3.75GM/PACKET N022362 002 Oct 02, 2009
TABLET;ORAL
WELCHOL
+ DAIICHI SANKYO 625MG N021176 001 May 26, 2000
COLESTIPOL HYDROCHLORIDE
GRANULE;ORAL
COLESTID
AB PHARMACIA AND UPJOHN 5GM/SCOOPFUL N017563 003 Sep 22, 1995
AB + 5GM/PACKET N017563 004 Sep 22, 1995
COLESTIPOL HYDROCHLORIDE
AB IMPAX LABS 5GM/SCOOPFUL A077277 001 May 02, 2006
AB 5GM/PACKET A077277 002 May 02, 2006
FLAVORED COLESTID
PHARMACIA AND UPJOHN 5GM/PACKET N017563 001
5GM/SCOOPFUL N017563 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-92( of 362)
COLESTIPOL HYDROCHLORIDE
TABLET;ORAL
COLESTID
AB + PHARMACIA AND UPJOHN
COLESTIPOL HYDROCHLORIDE
1GM N020222 001 Jul 19, 1994
AB IMPAX LABS 1GM A077510 001 Oct 24, 2006
COLISTIMETHATE SODIUM
INJECTABLE;INJECTION
COLISTIMETHATE SODIUM
AP EMCURE PHARMS LTD EQ 150MG BASE/VIAL A202359 001 Sep 28, 2012
AP FRESENIUS KABI USA EQ 150MG BASE/VIAL A065364 001 Apr 17, 2008
AP PADDOCK LLC EQ 150MG BASE/VIAL A065177 001 Mar 19, 2004
AP X GEN PHARMS EQ 150MG BASE/VIAL A064216 001 Feb 26, 1999
COLY-MYCIN M
AP + JHP PHARMS EQ 150MG BASE/VIAL N050108 002
COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE
SUSPENSION/DROPS;OTIC
COLY-MYCIN S
+ JHP PHARMS EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG N050356 001
BASE/ML;0.5MG/ML
CONIVAPTAN HYDROCHLORIDE
INJECTABLE;IV (INFUSION)
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER
+ ASTELLAS 20MG/100ML (0.2MG/ML) N021697 002 Oct 08, 2008
COPPER
INTRAUTERINE DEVICE;INTRAUTERINE
PARAGARD T 380A
+ TEVA WOMENS 309MG/COPPER N018680 001 Nov 15, 1984
CORTICORELIN OVINE TRIFLUTATE
INJECTABLE;INJECTION
ACTHREL
+ FERRING EQ 0.1MG BASE/VIAL N020162 001 May 23, 1996
CORTICOTROPIN
INJECTABLE;INJECTION
H.P. ACTHAR GEL
+ QUESTCOR PHARMS 80 UNITS/ML N008372 008
CORTISONE ACETATE
TABLET;ORAL
CORTISONE ACETATE
+ WEST WARD 25MG A080776 002
COSYNTROPIN
INJECTABLE;INJECTION
CORTROSYN
AP + AMPHASTAR PHARMS INC 0.25MG/VIAL N016750 001
COSYNTROPIN
AP MYLAN INSTITUTIONAL 0.25MG/VIAL A090574 001 Dec 17, 2009
AP SANDOZ 0.25MG/VIAL A202147 001 Jun 29, 2012
SOLUTION;INTRAVENOUS
COSYNTROPIN
SANDOZ 0.25MG/ML (0.25MG/ML) N022028 001 Feb 21, 2008
CRIZOTINIB
CAPSULE;ORAL
XALKORI
PF PRISM CV 200MG N202570 001 Aug 26, 2011
+ 250MG N202570 002 Aug 26, 2011
CROFELEMER
TABLET, DELAYED RELEASE;ORAL
FULYZAQ
+ SALIX PHARMS 125MG N202292 001 Dec 31, 2012
CROMOLYN SODIUM
CONCENTRATE;ORAL
CROMOLYN SODIUM
AA MICRO LABS LTD INDIA 100MG/5ML A202745 001 Apr 04, 2013
AA PACK PHARMS LLC 100MG/5ML A202583 001 Oct 27, 2011
GASTROCROM
AA + MEDA PHARMS 100MG/5ML N020479 001 Feb 29, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-93( of 362)
CROMOLYN SODIUM
SOLUTION;INHALATION
CROMOLYN SODIUM
AN BAUSCH AND LOMB 10MG/ML A075585 001 Dec 21, 2000
AN DEY 10MG/ML A074209 001 Apr 26, 1994
AN + TEVA PHARMS 10MG/ML A075271 001 Jan 18, 2000
AN WATSON LABS 10MG/ML A076469 001 Jun 17, 2005
AN WOCKHARDT 10MG/ML A075346 001 Oct 25, 1999
SOLUTION/DROPS;OPHTHALMIC
CROLOM
AT BAUSCH AND LOMB 4% A074443 001 Jan 30, 1995
CROMOLYN SODIUM
AT AKORN 4% A074706 001 Apr 29, 1998
AT ALCON 4% A075282 001 Jun 16, 1999
OPTICROM
AT + ALLERGAN 4% N018155 001 Oct 03, 1984
CROTAMITON
CREAM;TOPICAL
EURAX
+ RANBAXY 10% N006927 001
LOTION;TOPICAL
CROTAN
AT SUMMERS 10% A087204 001
EURAX
AT + RANBAXY 10% N009112 003
CUPRIC CHLORIDE
INJECTABLE;INJECTION
CUPRIC CHLORIDE IN PLASTIC CONTAINER
+ HOSPIRA EQ 0.4MG COPPER/ML N018960 001 Jun 26, 1986
CYANOCOBALAMIN
INJECTABLE;INJECTION
CYANOCOBALAMIN
AP + LUITPOLD 1MG/ML A080737 001
VIBISONE
AP + FRESENIUS KABI USA 1MG/ML A080557 003
SPRAY, METERED;NASAL
NASCOBAL
+ PAR PHARM 0.5MG/SPRAY N021642 001 Jan 31, 2005
CYCLOBENZAPRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
AMRIX
AB IVAX INTL 15MG N021777 001 Feb 01, 2007
AB + 30MG N021777 002 Feb 01, 2007
CYCLOBENZAPRINE HYDROCHLORIDE
AB MYLAN 15MG A090738 001 Apr 18, 2011
AB 30MG A090738 002 Apr 18, 2011
AB TWI PHARMS INC 15MG A091281 001 Jan 31, 2013
AB 30MG A091281 002 Jan 31, 2013
TABLET;ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
AB AUROBINDO PHARMA 5MG A078643 001 Sep 26, 2008
AB 10MG A078643 002 Sep 26, 2008
AB INVAGEN PHARMS 5MG A090478 001 Jul 23, 2010
AB 10MG A090478 002 Jul 23, 2010
AB JUBILANT CADISTA 5MG A077563 001 Apr 19, 2006
AB 10MG A077563 002 Apr 19, 2006
AB KVK TECH 5MG A078048 001 Feb 28, 2011
AB 10MG A078048 002 Feb 28, 2011
AB MUTUAL PHARM 5MG A073541 002 Apr 06, 2006
AB 10MG A073541 001 May 23, 1995
AB MYLAN PHARMS INC 5MG A073144 002 Feb 03, 2006
AB 7.5MG A073144 003 Mar 25, 2013
AB + 10MG A073144 001 May 30, 1991
AB ORIT LABS LLC 10MG A078218 001 Apr 18, 2008
AB PLIVA 10MG A074421 001 Sep 29, 1995
AB PROSAM LABS 10MG A077209 001 Oct 04, 2005
AB RANBAXY 5MG A078722 001 May 12, 2008
AB 7.5MG A078722 002 May 12, 2008
AB 10MG A078722 003 May 12, 2008
AB VINTAGE PHARMS 5MG A077797 001 Feb 28, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-94( of 362)
CYCLOBENZAPRINE HYDROCHLORIDE
TABLET;ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
AB 10MG A077797 002 Feb 28, 2007
AB WATSON LABS 5MG A071611 002 Feb 03, 2006
AB 7.5MG A071611 003 Feb 03, 2006
AB 10MG A071611 001 May 03, 1989
CYCLOPENTOLATE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AKPENTOLATE
AT AKORN 1% A040164 001 Jan 13, 1997
CYCLOGYL
AT + ALCON 1% A084110 001
PENTOLAIR
AT BAUSCH AND LOMB 1% A040075 001 Apr 29, 1994
CYCLOGYL
+ ALCON 0.5% A084109 001
+ ALCON LABS INC 2% A084108 001
CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CYCLOMYDRIL
+ ALCON 0.2%;1% A084300 001
CYCLOPHOSPHAMIDE
CAPSULE;ORAL
CYCLOPHOSPHAMIDE
ROXANE 25MG N203856 001 Sep 16, 2013
+ 50MG N203856 002 Sep 16, 2013
INJECTABLE;INJECTION
CYCLOPHOSPHAMIDE
AP + BAXTER HLTHCARE 1GM/VIAL A040745 002 May 21, 2008
AP + 2GM/VIAL A040745 003 May 21, 2008
AP + 500MG/VIAL A040745 001 May 21, 2008
CYTOXAN (LYOPHILIZED)
AP + BAXTER HLTHCARE 1GM/VIAL N012142 004 Aug 30, 1982
AP + 2GM/VIAL N012142 005 Aug 30, 1982
AP + 500MG/VIAL N012142 003
TABLET;ORAL
CYCLOPHOSPHAMIDE
ROXANE 25MG A040032 001 Aug 17, 1999
+ 50MG A040032 002 Aug 17, 1999
CYCLOSERINE
CAPSULE;ORAL
SEROMYCIN
+ PURDUE GMP 250MG A060593 001
CYCLOSPORINE
CAPSULE;ORAL
CYCLOSPORINE
AB1 IVAX SUB TEVA PHARMS 25MG A065110 003 Mar 29, 2005
AB1 50MG A065110 001 Mar 29, 2005
AB1 100MG A065110 002 Mar 29, 2005
AB1 SANDOZ 25MG A065017 002 Jan 13, 2000
AB1 100MG A065017 001 Jan 13, 2000
AB1 WATSON LABS INC 25MG A065044 002 Dec 20, 2000
AB1 100MG A065044 001 Dec 20, 2000
GENGRAF
AB1 ABBVIE 25MG A065003 001 May 12, 2000
AB1 50MG A065003 002 May 12, 2000
AB1 100MG A065003 003 May 12, 2000
NEORAL
AB1 NOVARTIS 25MG N050715 001 Jul 14, 1995
AB1 + 100MG N050715 002 Jul 14, 1995
CYCLOSPORINE
AB2 APOTEX 25MG A065040 001 May 09, 2002
AB2 100MG A065040 002 May 09, 2002
SANDIMMUNE
AB2 NOVARTIS 25MG N050625 001 Mar 02, 1990
AB2 + 100MG N050625 002 Mar 02, 1990
BX 50MG N050625 003 Nov 23, 1992
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-95( of 362)
CYCLOSPORINE
EMULSION;OPHTHALMIC
RESTASIS
+ ALLERGAN 0.05% N050790 001 Dec 23, 2002
INJECTABLE;INJECTION
CYCLOSPORINE
AP BEDFORD 50MG/ML A065004 001 Oct 29, 1999
AP LUITPOLD 50MG/ML A065151 001 Oct 07, 2003
SANDIMMUNE
AP + NOVARTIS 50MG/ML N050573 001 Nov 14, 1983
SOLUTION;ORAL
CYCLOSPORINE
AB1 ABBVIE 100MG/ML A065025 001 Mar 03, 2000
AB1 IVAX SUB TEVA PHARMS 100MG/ML A065078 001 Mar 25, 2005
AB1 WATSON LABS 100MG/ML A065054 001 Dec 18, 2001
NEORAL
AB1 + NOVARTIS 100MG/ML N050716 001 Jul 14, 1995
CYCLOSPORINE
AB2 WOCKHARDT 100MG/ML A065133 001 Sep 17, 2004
SANDIMMUNE
AB2 + NOVARTIS 100MG/ML N050574 001 Nov 14, 1983
CYPROHEPTADINE HYDROCHLORIDE
SYRUP;ORAL
CYPROHEPTADINE HYDROCHLORIDE
AA + LYNE 2MG/5ML A040668 001 Jun 28, 2006
AA PHARM ASSOC 2MG/5ML A091295 001 Mar 28, 2013
TABLET;ORAL
CYPROHEPTADINE HYDROCHLORIDE
AA COREPHARMA 4MG A040537 001 Sep 30, 2003
AA + IVAX SUB TEVA PHARMS 4MG A087056 001
AA PAR PHARM 4MG A087129 001
AA STASON PHARMS 4MG A040644 001 May 30, 2006
CYSTEAMINE BITARTRATE
CAPSULE;ORAL
CYSTAGON
MYLAN EQ 50MG BASE N020392 001 Aug 15, 1994
+ EQ 150MG BASE N020392 002 Aug 15, 1994
CAPSULE, DELAYED RELEASE;ORAL
PROCYSBI
RAPTOR PHARMS EQ 25MG BASE N203389 001 Apr 30, 2013
+ EQ 75MG BASE N203389 002 Apr 30, 2013
CYSTEAMINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CYSTARAN
+ SIGMA TAU EQ 0.44% BASE N200740 001 Oct 02, 2012
CYTARABINE
INJECTABLE;INJECTION
CYTARABINE
AP BEDFORD 1GM/VIAL A074245 001 Aug 31, 1994
AP 2GM/VIAL A074245 002 Aug 31, 1994
AP 100MG/VIAL A071471 001 Aug 02, 1989
AP 500MG/VIAL A071472 001 Aug 02, 1989
AP + FRESENIUS KABI USA 100MG/ML A076512 001 Jan 15, 2004
AP + HOSPIRA 20MG/ML A071868 001 Jun 04, 1990
AP + 20MG/ML A072168 001 Aug 31, 1990
AP + 20MG/ML A072945 001 Feb 28, 1994
AP 100MG/ML A075383 001 Nov 22, 1999
AP ONCO THERAPIES LTD 20MG/ML A200914 001 Dec 13, 2011
AP 20MG/ML A200915 001 Dec 13, 2011
AP 20MG/ML A200916 001 Dec 13, 2011
AP 100MG/ML A201784 001 Jan 30, 2012
CYTOSAR-U
AP + TEVA PHARMS USA 1GM/VIAL A075206 004 Dec 30, 1998
AP + 2GM/VIAL A075206 003 Dec 30, 1998
AP 100MG/VIAL A075206 001 Dec 30, 1998
AP + 500MG/VIAL A075206 002 Dec 30, 1998
INJECTABLE, LIPOSOMAL;INJECTION
DEPOCYT
+ PACIRA PHARMS INC 10MG/ML N021041 001 Apr 01, 1999
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-96( of 362)
DABIGATRAN ETEXILATE MESYLATE
CAPSULE;ORAL
PRADAXA
BOEHRINGER INGELHEIM EQ 75MG BASE N022512 001 Oct 19, 2010
+ EQ 150MG BASE N022512 002 Oct 19, 2010
DABRAFENIB MESYLATE
CAPSULE;ORAL
TAFINLAR
GLAXOSMITHKLINE EQ 50MG BASE N202806 001 May 29, 2013
+ EQ 75MG BASE N202806 002 May 29, 2013
DACARBAZINE
INJECTABLE;INJECTION
DACARBAZINE
AP BEDFORD 200MG/VIAL A075812 001 Jun 15, 2001
AP 500MG/VIAL A075812 002 Oct 31, 2002
AP FRESENIUS KABI USA 100MG/VIAL A075371 001 Aug 27, 1999
AP 200MG/VIAL A075371 002 Aug 27, 1999
AP HOSPIRA 200MG/VIAL A075940 001 Oct 18, 2001
AP TEVA PHARMS USA 200MG/VIAL A075259 002 Aug 27, 1998
AP + 500MG/VIAL A075259 001 Sep 22, 2000
DTIC-DOME
AP + BAYER HLTHCARE 100MG/VIAL N017575 001
AP + 200MG/VIAL N017575 002
DACTINOMYCIN
INJECTABLE;INJECTION
COSMEGEN
AP + RECORDATI RARE 0.5MG/VIAL N050682 001
DACTINOMYCIN
AP BEDFORD 0.5MG/VIAL A090304 001 Mar 16, 2010
AP LUITPOLD 0.5MG/VIAL A202562 001 Aug 23, 2013
DALFAMPRIDINE
TABLET, EXTENDED RELEASE;ORAL
AMPYRA
+ ACORDA 10MG N022250 001 Jan 22, 2010
DALFOPRISTIN; QUINUPRISTIN
INJECTABLE;IV (INFUSION)
SYNERCID
+ KING PHARMS 350MG/VIAL;150MG/VIAL N050748 001 Sep 21, 1999
DALTEPARIN SODIUM
INJECTABLE;SUBCUTANEOUS
FRAGMIN
EISAI INC 2,500IU/0.2ML (12,500IU/ML) N020287 001 Dec 22, 1994
5,000IU/0.2ML (25,000IU/ML) N020287 003 Mar 18, 1996
7,500IU/0.3ML (25,000IU/ML) N020287 005 Apr 04, 2002
10,000IU/ML (10,000IU/ML) N020287 004 Jan 30, 1998
12,500IU/0.5ML (25,000IU/ML) N020287 009 May 01, 2007
15,000IU/0.6ML (25,000IU/ML) N020287 010 May 01, 2007
18,000IU/0.72ML (25,000IU/ML) N020287 011 May 01, 2007
+ 95,000IU/3.8ML (25,000IU/ML) N020287 006 Apr 04, 2002
DANAZOL
CAPSULE;ORAL
DANAZOL
AB BARR 50MG A074582 003 May 29, 1998
AB 100MG A074582 002 May 29, 1998
AB + 200MG A074582 001 Aug 09, 1996
AB LANNETT 50MG A078214 001 Apr 19, 2007
AB 100MG A078214 002 Apr 19, 2007
AB 200MG A077246 001 Sep 28, 2005
DANTROLENE SODIUM
CAPSULE;ORAL
DANTRIUM
AB JHP PHARMS 25MG N017443 001
AB 50MG N017443 003
AB + 100MG N017443 002
DANTROLENE SODIUM
AB IMPAX LABS 25MG A076856 001 Mar 01, 2005
AB 50MG A076856 002 Mar 01, 2005
AB 100MG A076856 003 Mar 01, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-97( of 362)
DANTROLENE SODIUM
CAPSULE;ORAL
DANTROLENE SODIUM
AB MIKAH PHARMA 25MG A076686 001 Oct 24, 2005
AB 50MG A076686 002 Oct 24, 2005
AB 100MG A076686 003 Oct 24, 2005
INJECTABLE;INJECTION
DANTRIUM
AP + JHP PHARMS 20MG/VIAL N018264 001
DANTROLENE SODIUM
AP US WORLDMEDS 20MG/VIAL A078378 001 Jul 24, 2007
DAPSONE
GEL;TOPICAL
ACZONE
+ ALLERGAN 5% N021794 001 Jul 07, 2005
TABLET;ORAL
DAPSONE
JACOBUS 25MG A086841 001
+ 100MG A086842 001
DAPTOMYCIN
INJECTABLE;IV (INFUSION)
CUBICIN
+ CUBIST 500MG/VIAL N021572 002 Sep 12, 2003
DARIFENACIN HYDROBROMIDE
TABLET, EXTENDED RELEASE;ORAL
ENABLEX
WARNER CHILCOTT LLC EQ 7.5MG BASE N021513 001 Dec 22, 2004
+ EQ 15MG BASE N021513 002 Dec 22, 2004
DARUNAVIR ETHANOLATE
SUSPENSION;ORAL
PREZISTA
+ JANSSEN PRODS EQ 100MG BASE/ML N202895 001 Dec 16, 2011
TABLET;ORAL
PREZISTA
JANSSEN PRODS EQ 75MG BASE N021976 004 Dec 18, 2008
EQ 150MG BASE N021976 005 Dec 18, 2008
EQ 600MG BASE N021976 002 Feb 25, 2008
+ EQ 800MG BASE N021976 006 Nov 09, 2012
DASATINIB
TABLET;ORAL
SPRYCEL
BRISTOL MYERS SQUIBB 20MG N021986 001 Jun 28, 2006
50MG N021986 002 Jun 28, 2006
70MG N021986 003 Jun 28, 2006
80MG N021986 005 Oct 28, 2010
100MG N021986 004 May 30, 2008
+ 140MG N021986 006 Oct 28, 2010
DAUNORUBICIN CITRATE
INJECTABLE, LIPOSOMAL;INJECTION
DAUNOXOME
+ GALEN (UK) EQ 2MG BASE/ML N050704 002 Apr 08, 1996
DAUNORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
CERUBIDINE
AP + BEDFORD EQ 20MG BASE/VIAL A064103 001 Feb 03, 1995
DAUNORUBICIN HYDROCHLORIDE
AP + BEDFORD EQ 5MG BASE/ML N050731 001 Jan 30, 1998
AP FRESENIUS KABI USA EQ 20MG BASE/VIAL A065000 001 May 25, 1999
AP TEVA PHARMS USA EQ 5MG BASE/ML A065035 001 Jan 24, 2000
FRESENIUS KABI USA EQ 5MG BASE/VIAL A065034 001 Nov 20, 2001
DECITABINE
INJECTABLE;INTRAVENOUS
DACOGEN
AP + EISAI INC 50MG/VIAL N021790 001 May 02, 2006
DECITABINE
AP DR REDDYS LABS LTD 50MG/VIAL A203131 001 Jul 11, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
DEFERASIROX
TABLET, FOR SUSPENSION;ORAL
EXJADE
NOVARTIS
+
DEFERIPRONE
TABLET;ORAL
FERRIPROX
+ APOPHARMA INC
DEFEROXAMINE MESYLATE
INJECTABLE;INJECTION
DEFEROXAMINE MESYLATE
AP BEDFORD
AP
AP FRESENIUS KABI USA
AP
AP HOSPIRA
AP
AP WATSON LABS
AP
DESFERAL
AP + NOVARTIS
AP +
DEGARELIX ACETATE
POWDER;SUBCUTANEOUS
FIRMAGON
FERRING
+
DELAVIRDINE MESYLATE
TABLET;ORAL
RESCRIPTOR
VIIV HLTHCARE
+
DEMECLOCYCLINE HYDROCHLORIDE
TABLET;ORAL
DEMECLOCYCLINE HYDROCHLORIDE
125MG
250MG
500MG
500MG
2GM/VIAL
500MG/VIAL
2GM/VIAL
500MG/VIAL
2GM/VIAL
500MG/VIAL
2GM/VIAL
500MG/VIAL
2GM/VIAL
500MG/VIAL
EQ 80MG BASE/VIAL
EQ 120MG BASE/VIAL
100MG
200MG
AB AMNEAL PHARM
AB +
AB BARR
AB
AB IMPAX LABS
AB
AB VERSAPHARM
AB
DESFLURANE
LIQUID;INHALATION
SUPRANE
+ BAXTER HLTHCARE
DESIPRAMINE HYDROCHLORIDE
TABLET;ORAL
DESIPRAMINE HYDROCHLORIDE
AB ACTAVIS TOTOWA
AB
AB
AB
AB
AB
AB SANDOZ
AB
AB
AB
AB
AB
NORPRAMIN
AB SANOFI AVENTIS US
AB
AB
AB
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
99.9%
10MG
25MG
50MG
75MG
100MG
150MG
10MG
25MG
50MG
75MG
100MG
150MG
10MG
25MG
50MG
75MG
3-98( of 362)
N021882 001 Nov 02, 2005
N021882 002 Nov 02, 2005
N021882 003 Nov 02, 2005
N021825 001 Oct 14, 2011
A078086 002 May 30, 2007
A078086 001 May 30, 2007
A078718 002 Sep 15, 2009
A078718 001 Sep 15, 2009
A076019 002 Mar 17, 2004
A076019 001 Mar 17, 2004
A076806 002 Mar 31, 2006
A076806 001 Mar 31, 2006
N016267 002 May 25, 2000
N016267 001
N022201 001 Dec 24, 2008
N022201 002 Dec 24, 2008
N020705 001 Apr 04, 1997
N020705 002 Jul 14, 1999
A065425 001 Feb 27, 2008
A065425 002 Feb 27, 2008
A065171 001 Dec 13, 2004
A065171 002 Dec 13, 2004
A065094 001 Mar 22, 2004
A065094 002 Mar 22, 2004
A065389 001 Dec 01, 2008
A065389 002 Dec 01, 2008
N020118 001 Sep 18, 1992
A074430 001 Feb 09, 1996
A071601 001 Jun 05, 1987
A071588 001 Jun 05, 1987
A071602 001 Oct 05, 1987
A071766 001 Oct 05, 1987
A074430 002 Feb 09, 1996
A072099 001 May 24, 1988
A072100 001 May 24, 1988
A072101 001 May 24, 1988
A072102 001 Jun 20, 1988
A072103 001 Jun 20, 1988
A072104 001 Jun 20, 1988
N014399 007 Feb 11, 1982
N014399 001
N014399 003
N014399 004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-99( of 362)
DESIPRAMINE HYDROCHLORIDE
TABLET;ORAL
NORPRAMIN
AB + 100MG N014399 005
AB 150MG N014399 006
DESIRUDIN RECOMBINANT
INJECTABLE;SUBCUTANEOUS
IPRIVASK
+ MARATHON PHARMS LLC 15MG/VIAL N021271 001 Apr 04, 2003
DESLORATADINE
SYRUP;ORAL
CLARINEX
+ MERCK SHARP DOHME 0.5MG/ML N021300 001 Sep 01, 2004
TABLET;ORAL
CLARINEX
AB + MERCK SHARP DOHME 5MG N021165 001 Dec 21, 2001
DESLORATADINE
AB BELCHER PHARMS 5MG A078355 001 Apr 19, 2012
AB DR REDDYS LABS LTD 5MG A078365 001 Mar 08, 2011
AB LUPIN PHARMS 5MG A078352 001 Oct 25, 2010
AB MYLAN PHARMS INC 5MG A078351 001 Feb 10, 2012
AB ORCHID HLTHCARE 5MG A078357 001 Feb 19, 2010
AB PERRIGO R AND D 5MG A078361 001 Dec 22, 2011
AB SANDOZ 5MG A078364 001 Dec 03, 2010
AB SUN PHARM INDS 5MG A078359 001 Nov 16, 2010
TABLET, ORALLY DISINTEGRATING;ORAL
CLARINEX
AB MERCK SHARP DOHME 2.5MG N021312 002 Jul 14, 2005
AB + 5MG N021312 001 Jun 26, 2002
DESLORATADINE
AB REDDYS 2.5MG A078367 001 Jul 12, 2010
AB 5MG A078367 002 Jul 12, 2010
DESLORATADINE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
CLARINEX D 24 HOUR
AB + MERCK SHARP DOHME 5MG;240MG N021605 001 Mar 03, 2005
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR
AB DR REDDYS LABS LTD 5MG;240MG A078366 001 Apr 26, 2011
CLARINEX-D 12 HOUR
+ MERCK SHARP DOHME 2.5MG;120MG N021313 001 Feb 01, 2006
DESMOPRESSIN ACETATE
INJECTABLE;INJECTION
DDAVP
AP + SANOFI AVENTIS US 0.004MG/ML N018938 001 Mar 30, 1984
DESMOPRESSIN ACETATE
AP HOSPIRA 0.004MG/ML A075220 001 Aug 28, 2000
AP SUN PHARM INDS LTD 0.004MG/ML A091280 001 Jan 25, 2013
AP TEVA PHARMS USA 0.004MG/ML A074888 001 Oct 15, 1997
SOLUTION;NASAL
DDAVP
AB + SANOFI AVENTIS US 0.01% N017922 001
DESMOPRESSIN ACETATE
AB SUN PHARM INDS 0.01% A077212 001 Apr 12, 2012
DESMOPRESSIN ACETATE
AB SUN PHARMA GLOBAL 0.01% A078271 001 Dec 23, 2013
SPRAY, METERED;NASAL
DDAVP (NEEDS NO REFRIGERATION)
AB + SANOFI AVENTIS US 0.01MG/SPRAY N017922 003 Aug 07, 1996
DESMOPRESSIN ACETATE
AB + BAUSCH AND LOMB 0.01MG/SPRAY A074830 001 Jan 25, 1999
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
AB APOTEX INC 0.01MG/SPRAY A076703 001 Jan 27, 2005
MINIRIN
AB + FERRING 0.01MG/SPRAY N021333 001 Sep 16, 2002
STIMATE (NEEDS NO REFRIGERATION)
+ CSL BEHRING 1.5MG/SPRAY N020355 002 Oct 24, 2007
TABLET;ORAL
DDAVP
AB SANOFI AVENTIS US 0.1MG N019955 001 Sep 06, 1995
AB + 0.2MG N019955 002 Sep 06, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-100( of 362)
DESMOPRESSIN ACETATE
TABLET;ORAL
DESMOPRESSIN ACETATE
AB APOTEX INC 0.1MG A077414 001 Mar 07, 2006
AB 0.2MG A077414 002 Mar 07, 2006
AB TEVA PHARMS 0.1MG A077122 001 Jan 25, 2006
AB 0.2MG A077122 002 Jan 25, 2006
AB WATSON LABS 0.1MG A076470 001 Jul 01, 2005
AB 0.2MG A076470 002 Jul 01, 2005
FERRING 0.1MG N021795 001 May 08, 2008
+ 0.2MG N021795 002 May 08, 2008
DESOGESTREL; ETHINYL ESTRADIOL
TABLET;ORAL-28
CYCLESSA
AB + ORGANON USA INC 0.125MG;0.15MG;0.1MG;0.025MG;0.025MG;0. N021090 001 Dec 20, 2000
025MG
DESOGEN
AB ORGANON USA INC 0.15MG;0.03MG N020071 002 Dec 10, 1992
DESOGESTREL AND ETHINYL ESTRADIOL
AB DURAMED PHARMS BARR 0.15MG;0.03MG A075256 002 Aug 12, 1999
AB FAMY CARE LTD 0.15MG,N/A;0.02MG,0.01MG A202296 001 Aug 30, 2013
AB NOVAST LABS LTD 0.15MG;0.03MG A091234 001 Jul 12, 2013
AB WATSON LABS 0.15MG,N/A;0.02MG,0.01MG;0.02MG,0.01MG A076916 001 Dec 29, 2008
AB 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0. A077182 001 Jan 24, 2006
025MG
AB 0.15MG;0.03MG A076915 001 Jul 29, 2005
EMOQUETTE
AB VINTAGE PHARMS LLC 0.15MG;0.03MG A076675 001 Feb 25, 2011
ENSKYCE
AB LUPIN LTD 0.15MG;0.03MG A201887 001 Mar 07, 2013
KARIVA
AB BARR 0.15MG,N/A;0.02MG,0.01MG;0.02MG,0.01MG A075863 001 Apr 05, 2002
MIRCETTE
AB + TEVA BRANDED PHARM 0.15MG,N/A;0.02MG,0.01MG;0.02MG,0.01MG N020713 001 Apr 22, 1998
ORTHO-CEPT
AB + JANSSEN PHARMS 0.15MG;0.03MG N020301 002 Dec 14, 1992
PIMTREA
AB NOVAST LABS LTD 0.15MG,N/A;0.02MG,0.01MG A091247 001 Aug 01, 2013
VELIVET
AB DURAMED PHARMS BARR 0.125MG;0.15MG;0.1MG;0.025MG;0.025MG;0. A076455 001 Feb 24, 2004
025MG
VIORELE
AB GLENMARK GENERICS 0.15MG,N/A;0.02MG,0.01MG A091346 001 Apr 02, 2012
DESONIDE
AEROSOL, FOAM;TOPICAL
VERDESO
+ STIEFEL LABS INC 0.05% N021978 001 Sep 19, 2006
CREAM;TOPICAL
DESONIDE
AB + PERRIGO NEW YORK 0.05% N017010 001
AB TARO 0.05% A073548 001 Jun 30, 1992
DESOWEN
AB GALDERMA LABS LP 0.05% N019048 001 Dec 14, 1984
GEL;TOPICAL
DESONATE
+ BAYER HLTHCARE 0.05% N021844 001 Oct 20, 2006
LOTION;TOPICAL
DESONIDE
AB FOUGERA PHARMS 0.05% A075860 001 Mar 19, 2002
DESOWEN
AB + GALDERMA LABS LP 0.05% A072354 001 Jan 24, 1992
OINTMENT;TOPICAL
DESONIDE
AB FOUGERA PHARMS 0.05% A075751 001 Mar 12, 2001
AB + PERRIGO NEW YORK 0.05% N017426 001
AB TARO 0.05% A074254 001 Aug 03, 1994
DESOWEN
AB GALDERMA LABS LP 0.05% A071425 001 Jun 15, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-101( of 362)
DESOXIMETASONE
CREAM;TOPICAL
DESOXIMETASONE
AB FOUGERA PHARMS 0.25% A078369 001 Jun 29, 2010
AB PERRIGO NEW YORK 0.25% A076510 001 Jul 01, 2003
TOPICORT
AB + TARO 0.25% A073193 001 Nov 30, 1990
+ 0.05% A073210 001 Nov 30, 1990
GEL;TOPICAL
DESOXIMETASONE
AB PERRIGO NEW YORK 0.05% A077552 001 Jan 09, 2006
AB VERSAPHARM 0.05% A090727 001 Mar 10, 2011
TOPICORT
AB + TARO 0.05% A074904 001 Jul 14, 1998
OINTMENT;TOPICAL
DESOXIMETASONE
AB FOUGERA PHARMS 0.25% A078657 001 Sep 28, 2012
AB GLENMARK GENERICS 0.25% A202838 001 Sep 20, 2013
TOPICORT
AB + TARO 0.25% A074286 001 Jun 07, 1996
+ TARO PHARMS NORTH 0.05% N018594 001 Jan 17, 1985
SPRAY;TOPICAL
TOPICORT
+ TARO 0.25% N204141 001 Apr 11, 2013
DESVENLAFAXINE
TABLET, EXTENDED RELEASE;ORAL
DESVENLAFAXINE
BC + ALEMBIC PHARMS LTD 50MG N204150 001 Mar 04, 2013
BC + 100MG N204150 002 Mar 04, 2013
KHEDEZLA
BC OSMOTICA PHARM CORP 50MG N204683 001 Jul 10, 2013
BC 100MG N204683 002 Jul 10, 2013
DESVENLAFAXINE FUMARATE
TABLET, EXTENDED RELEASE;ORAL
DESVENLAFAXINE FUMARATE
+ TEVA PHARMS USA EQ 50MG BASE N205208 001 Oct 11, 2013
+ EQ 100MG BASE N205208 002 Oct 11, 2013
DESVENLAFAXINE SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
PRISTIQ
+ WYETH PHARMS INC EQ 50MG BASE N021992 001 Feb 29, 2008
+ EQ 100MG BASE N021992 002 Feb 29, 2008
DEXAMETHASONE
CONCENTRATE;ORAL
DEXAMETHASONE INTENSOL
+ ROXANE 1MG/ML A088252 001 Sep 01, 1983
ELIXIR;ORAL
DEXAMETHASONE
AA LYNE 0.5MG/5ML A090891 001 Jul 12, 2011
AA + STI PHARMA LLC 0.5MG/5ML A084754 001
AA VINTAGE PHARMS 0.5MG/5ML A091188 001 May 11, 2011
AA WOCKHARDT EU OPERATN 0.5MG/5ML A088254 001 Jul 27, 1983
IMPLANT;INTRAVITREAL
OZURDEX
+ ALLERGAN 0.7MG N022315 001 Jun 17, 2009
SOLUTION;ORAL
DEXAMETHASONE
+ ROXANE 0.5MG/5ML A088248 001 Sep 01, 1983
SUSPENSION/DROPS;OPHTHALMIC
MAXIDEX
+ ALCON 0.1% N013422 001
TABLET;ORAL
DEXAMETHASONE
AB ECR 1.5MG A040700 001 Aug 15, 2008
AB ROXANE 1.5MG A084610 001
BP PAR PHARM 0.5MG A088148 001 Apr 28, 1983
BP 0.75MG A088160 001 Apr 28, 1983
BP 1.5MG A088237 001 Apr 28, 1983
BP 4MG A088238 001 Apr 28, 1983
BP + 6MG A088481 001 Nov 28, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-102( of 362)
DEXAMETHASONE
TABLET;ORAL
DEXAMETHASONE
BP ROXANE 0.5MG A084611 001
BP 0.75MG A084613 001
BP 1MG A088306 001 Sep 15, 1983
BP 2MG A087916 001 Aug 26, 1982
BP 4MG A084612 001
BP + 6MG A088316 001 Sep 15, 1983
DEXAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
DEXAMETHASONE SODIUM PHOSPHATE
AP AGILA SPECLTS EQ 4MG PHOSPHATE/ML A040803 001 Aug 29, 2008
AP EQ 10MG PHOSPHATE/ML A040802 001 Aug 29, 2008
AP FRESENIUS KABI USA EQ 4MG PHOSPHATE/ML A084916 001
AP + EQ 10MG PHOSPHATE/ML A040491 001 Apr 11, 2003
AP + EQ 10MG PHOSPHATE/ML A040572 001 Apr 22, 2005
AP + HIKMA MAPLE EQ 10MG PHOSPHATE/ML A087702 001 Sep 07, 1982
AP + LUITPOLD EQ 4MG PHOSPHATE/ML A087440 001 Jul 21, 1982
SOLUTION/DROPS;OPHTHALMIC, OTIC
DEXAMETHASONE SODIUM PHOSPHATE
AT + ALCON PHARMS LTD EQ 0.1% PHOSPHATE A088771 001 Jan 16, 1985
AT BAUSCH AND LOMB EQ 0.1% PHOSPHATE A040069 001 Jul 26, 1996
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
MAXITROL
AT + FALCON PHARMS 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM N050065 002
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
AT BAUSCH AND LOMB 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM A064063 001 Jul 25, 1994
AT PERRIGO CO TENNESSEE 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM A062938 001 Jul 31, 1989
SUSPENSION/DROPS;OPHTHALMIC
DEXASPORIN
AT BAUSCH AND LOMB 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A064135 001 Sep 13, 1995
MAXITROL
AT ALCON 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062341 001 May 22, 1984
AT + FALCON PHARMS 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N050023 002
DEXAMETHASONE; TOBRAMYCIN
OINTMENT;OPHTHALMIC
TOBRADEX
+ ALCON 0.1%;0.3% N050616 001 Sep 28, 1988
SUSPENSION/DROPS;OPHTHALMIC
TOBRADEX
AB + ALCON 0.1%;0.3% N050592 001 Aug 18, 1988
TOBRAMYCIN AND DEXAMETHASONE
AB BAUSCH AND LOMB 0.1%;0.3% A064134 001 Oct 27, 1999
TOBRADEX ST
+ ALCON PHARMS LTD 0.05%;0.3% N050818 001 Feb 13, 2009
DEXCHLORPHENIRAMINE MALEATE
SYRUP;ORAL
DEXCHLORPHENIRAMINE MALEATE
+ WOCKHARDT 2MG/5ML A088251 001 Mar 23, 1984
DEXLANSOPRAZOLE
CAPSULE, DELAYED RELEASE;ORAL
DEXILANT
TAKEDA PHARMS 30MG N022287 001 Jan 30, 2009
+ 60MG N022287 002 Jan 30, 2009
DEXMEDETOMIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
PRECEDEX
+ HOSPIRA EQ 100MCG BASE/ML (EQ100MCG BASE/ML) N021038 001 Dec 17, 1999
+ EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) N021038 002 Mar 13, 2013
+ EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) N021038 003 Mar 13, 2013
DEXMETHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDE
AB INTELLIPHARMACEUTICS 15MG A078992 003 Nov 18, 2013
AB 30MG A078992 004 Nov 18, 2013
AB MYLAN PHARMS INC 30MG A202580 001 Aug 28, 2013
AB TEVA PHARMS USA 5MG A078908 001 Nov 19, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-103( of 362)
DEXMETHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDE
AB 10MG A078908 002 Nov 19, 2013
AB 20MG A078908 003 Nov 19, 2013
AB 40MG A202731 002 Nov 19, 2013
AB WATSON LABS INC 30MG A079108 005 Nov 21, 2013
FOCALIN XR
AB NOVARTIS 5MG N021802 001 May 26, 2005
AB 10MG N021802 002 May 26, 2005
AB 15MG N021802 004 Aug 01, 2006
AB 20MG N021802 003 May 26, 2005
AB 30MG N021802 005 Oct 23, 2009
AB + 40MG N021802 006 Aug 11, 2010
25MG N021802 008 Apr 21, 2011
35MG N021802 007 Apr 21, 2011
TABLET;ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDE
AB TEVA PHARMS 2.5MG A077107 003 Jan 29, 2007
AB 5MG A077107 001 Jan 29, 2007
AB 10MG A077107 002 Jan 29, 2007
FOCALIN
AB NOVARTIS 2.5MG N021278 001 Nov 13, 2001
AB 5MG N021278 002 Nov 13, 2001
AB + 10MG N021278 003 Nov 13, 2001
DEXRAZOXANE HYDROCHLORIDE
INJECTABLE;INJECTION
DEXRAZOXANE HYDROCHLORIDE
AP BEDFORD EQ 250MG BASE/VIAL A076068 001 Sep 28, 2004
AP EQ 500MG BASE/VIAL A076068 002 Sep 28, 2004
AP MYLAN INSTITUTIONAL EQ 250MG BASE/VIAL A200752 001 Oct 19, 2011
AP EQ 500MG BASE/VIAL A200752 002 Oct 19, 2011
ZINECARD
AP + PHARMACIA AND UPJOHN EQ 250MG BASE/VIAL N020212 001 May 26, 1995
AP + EQ 500MG BASE/VIAL N020212 002 May 26, 1995
TOTECT
+ BIOCODEX INC EQ 500MG BASE/VIAL N022025 001 Sep 06, 2007
DEXTROAMPHETAMINE SULFATE
CAPSULE, EXTENDED RELEASE;ORAL
DEXEDRINE
AB AMEDRA PHARMS 5MG N017078 001
AB 10MG N017078 002
AB + 15MG N017078 003
DEXTROAMPHETAMINE SULFATE
AB ACTAVIS ELIZABETH 5MG A203901 001 Nov 30, 2012
AB 10MG A203901 002 Nov 30, 2012
AB 15MG A203901 003 Nov 30, 2012
AB BARR 5MG A076137 001 Jan 18, 2002
AB 10MG A076137 002 Jan 18, 2002
AB 15MG A076137 003 Jan 18, 2002
AB MALLINCKRODT 5MG A076353 001 May 06, 2003
AB 10MG A076353 002 May 06, 2003
AB 15MG A076353 003 May 06, 2003
SOLUTION;ORAL
DEXTROAMPHETAMINE SULFATE
AA + OUTLOOK PHARMS 5MG/5ML A040776 001 Jan 29, 2008
AA TRIS PHARMA INC 5MG/5ML A203644 001 May 29, 2013
TABLET;ORAL
DEXTROAMPHETAMINE SULFATE
AA AUROLIFE PHARMA LLC 5MG A202893 001 Jul 31, 2013
AA 10MG A202893 002 Jul 31, 2013
AA BARR 5MG A040361 001 Jan 31, 2001
AA + 10MG A040361 002 Jan 31, 2001
AA MALLINCKRODT 5MG A040436 001 Jan 29, 2002
AA 10MG A040436 002 Jan 29, 2002
AA MIKART 5MG A090533 002 Oct 25, 2011
AA 10MG A090533 004 Oct 25, 2011
2.5MG A090533 001 Oct 25, 2011
7.5MG A090533 003 Oct 25, 2011
15MG A090533 005 Oct 25, 2011
20MG A090533 006 Oct 25, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-104( of 362)
DEXTROAMPHETAMINE SULFATE
TABLET;ORAL
DEXTROAMPHETAMINE SULFATE
30MG A090533 007 Oct 25, 2011
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PROMETH W/ DEXTROMETHORPHAN
AA + ACTAVIS MID ATLANTIC 15MG/5ML;6.25MG/5ML A088762 001 Oct 31, 1984
PROMETHAZINE DM
AA VINTAGE 15MG/5ML;6.25MG/5ML A040649 001 Feb 14, 2006
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
AA AMNEAL PHARMS 15MG/5ML;6.25MG/5ML A090575 001 Feb 08, 2011
AA HI TECH PHARMA 15MG/5ML;6.25MG/5ML A040027 001 Jul 31, 1996
AA TRIS PHARMA INC 15MG/5ML;6.25MG/5ML A091687 001 Jun 28, 2012
PROMETHAZINE W/ DEXTROMETHORPHAN
AA WOCKHARDT 15MG/5ML;6.25MG/5ML A088864 001 Jan 04, 1985
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
CAPSULE;ORAL
NUEDEXTA
+ AVANIR PHARMS 20MG;10MG N021879 001 Oct 29, 2010
DEXTROSE
INJECTABLE;INJECTION
DEXTROSE 10% IN PLASTIC CONTAINER
AP + B BRAUN 10GM/100ML N019626 004 Feb 02, 1988
AP + BAXTER HLTHCARE 10GM/100ML N016694 001
AP + HOSPIRA 10GM/100ML N018080 001
DEXTROSE 20% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 20GM/100ML N017521 004
AP + HOSPIRA 20GM/100ML N018564 001 Mar 23, 1982
DEXTROSE 30% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 30GM/100ML N017521 003
AP + HOSPIRA 30GM/100ML N019345 001 Jan 26, 1985
DEXTROSE 40% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 40GM/100ML N017521 002
AP + HOSPIRA 40GM/100ML N018562 001 Mar 23, 1982
DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 5GM/100ML N016730 001
AP + 5GM/100ML N019626 002 Feb 02, 1988
AP + 50MG/ML N016730 002
AP + BAXTER HLTHCARE 5GM/100ML N016673 001
AP + 5GM/100ML N020179 001 Dec 07, 1992
AP + 50MG/ML N016673 003 Oct 30, 1985
AP + 50MG/ML N020179 002 Dec 07, 1992
AP + HOSPIRA 5GM/100ML N019466 001 Jul 15, 1985
AP + 5GM/100ML N019479 001 Sep 17, 1985
AP + 50MG/ML N016367 002
AP + 50MG/ML N019222 001 Jul 13, 1984
DEXTROSE 50% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 50GM/100ML N017521 001
AP + 50GM/100ML N020047 001 Jul 02, 1991
AP + HOSPIRA 50GM/100ML N018563 001 Mar 23, 1982
AP + 50GM/100ML N019894 001 Dec 26, 1989
AP 500MG/ML N019445 001 Jun 03, 1986
DEXTROSE 60% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 60GM/100ML N017521 005 Mar 26, 1982
DEXTROSE 70% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 70GM/100ML N017521 006 Mar 26, 1982
AP + 70GM/100ML N020047 003 Jul 02, 1991
AP + HOSPIRA 70GM/100ML N018561 001 Mar 23, 1982
AP + 70GM/100ML N019893 001 Dec 26, 1989
DEXTROSE 25%
+ HOSPIRA 250MG/ML N019445 002 Nov 23, 1998
DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;32MG/100ML;128MG/100ML;234MG/ N017385 001
100ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-105( of 362)
DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;21MG/100ML;128MG/100ML;234MG/ N017610 001
100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
INJECTABLE;INJECTION
ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;31MG/100ML;130MG/100ML;26MG/1 N019873 001 Jun 10, 1993
00ML;320MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE;
SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
INJECTABLE;INJECTION
IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;53MG/100ML;100MG/100ML;100MG/ N019515 001 May 08, 1986
100ML;180MG/100ML;280MG/100ML;16MG/100M
L
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE;
SODIUM LACTATE
INJECTABLE;INJECTION
DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;31MG/100ML;141MG/100ML;20MG/1 N017484 001
00ML;12MG/100ML;260MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE;
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
INJECTABLE;INJECTION
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;30MG/100ML;141MG/100ML;15MG/1 N019513 001 May 08, 1986
00ML;260MG/100ML;25MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;30MG/100ML;97MG/100ML;220MG/1 N019844 001 Jun 10, 1993
00ML;140MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
GLUCONATE
INJECTABLE;INJECTION
ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;30MG/100ML;37MG/100ML;370MG/1
00ML;530MG/100ML;500MG/100ML
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;30MG/100ML;37MG/100ML;222MG/1
00ML;526MG/100ML;502MG/100ML
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;30MG/100ML;37MG/100ML;368MG/1
00ML;526MG/100ML;502MG/100ML
DEXTROSE; POTASSIUM CHLORIDE
INJECTABLE;INJECTION
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML
AP 5GM/100ML;150MG/100ML
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML
AP 5GM/100ML;300MG/100ML
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
AP HOSPIRA 5GM/100ML;224MG/100ML
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;149MG/100ML
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;298MG/100ML
N019843 001 Aug 09, 1993
N017609 001
N017451 001
N017634 004
N017634 001
N017634 003
N017634 002
N018744 001 Nov 09, 1982
N018744 002 Nov 09, 1982
N019699 004 Sep 29, 1989
N018744 004 Nov 09, 1982
N019699 006 Sep 29, 1989
N018371 003
N018371 001
N018371 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-106( of 362)
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;130MG/100ML;280MG N019870 001 Jun 10, 1993
/100ML;91MG/100ML
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;205MG/100ML;100MG/100ML;120MG
/100ML;220MG/100ML
N018840 001 Jun 29, 1983
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;200MG/100ML
AP 5GM/100ML;150MG/100ML;200MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;200MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;200MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;200MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;200MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;200MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;200MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;200MG/100ML
N018037 006 Apr 13, 1982
N018037 007 Apr 13, 1982
N018037 004
N018037 008 Apr 13, 1982
N018037 001
N018037 005 Apr 13, 1982
N018037 009 Apr 13, 1982
N018037 002
N018037 003
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;330MG/100ML N018629 005 Mar 23, 1982
AP 5GM/100ML;150MG/100ML;330MG/100ML N018629 002 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;330MG/100ML N018629 003 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;330MG/100ML N018629 004 Mar 23, 1982
AP 5GM/100ML;300MG/100ML;330MG/100ML N018629 006 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;330MG/100ML N018629 007 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;330MG/100ML N018629 008 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;330MG/100ML N018629 001 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 010
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;200MG/100ML N019630 008 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;330MG/100ML N019630 014 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;450MG/100ML N019630 020 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;900MG/100ML N019630 026 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;200MG/100ML N019630 010 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;330MG/100ML N019630 016 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;450MG/100ML N019630 022 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;900MG/100ML N019630 028 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;200MG/100ML N019630 012 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;330MG/100ML N019630 018 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;450MG/100ML N019630 024 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
AP
AP
B BRAUN 5GM/100ML;300MG/100ML;900MG/100ML N019630 030 Feb 17, 1988
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;75MG/100ML;450MG/100ML N018008 005 Apr 28, 1982
5GM/100ML;150MG/100ML;450MG/100ML N018008 006 Apr 28, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-107( of 362)
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP HOSPIRA 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 005 Mar 28, 1988
AP 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 009 Jul 05, 1983
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
BAXTER HLTHCARE 5GM/100ML;75MG/100ML;900MG/100ML N019308 004 Apr 05, 1985
5GM/100ML;150MG/100ML;900MG/100ML N019308 002 Apr 05, 1985
HOSPIRA 5GM/100ML;74.5MG/100ML;900MG/100ML N019691 002 Mar 24, 1988
5GM/100ML;149MG/100ML;900MG/100ML N019691 004 Mar 24, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;224MG/100ML;450MG/100ML N018362 006 Mar 28, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;224MG/100ML;900MG/100ML N019691 006 Mar 24, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;150MG/100ML;450MG/100ML N018008 007 Apr 28, 1982
HOSPIRA 5GM/100ML;149MG/100ML;450MG/100ML N018362 010 Jul 05, 1983
5GM/100ML;298MG/100ML;450MG/100ML N018362 007 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;150MG/100ML;900MG/100ML N019308 005 Apr 05, 1985
5GM/100ML;300MG/100ML;900MG/100ML N019308 003 Apr 05, 1985
HOSPIRA 5GM/100ML;149MG/100ML;900MG/100ML N019691 005 Mar 24, 1988
5GM/100ML;298MG/100ML;900MG/100ML N019691 008 Mar 24, 1988
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;224MG/100ML;450MG/100ML N018008 008 Apr 28, 1982
HOSPIRA 5GM/100ML;224MG/100ML;450MG/100ML N018362 002
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;224MG/100ML;900MG/100ML N019308 006 Apr 05, 1985
HOSPIRA 5GM/100ML;224MG/100ML;900MG/100ML N019691 007 Mar 24, 1988
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 009 Apr 28, 1982
HOSPIRA 5GM/100ML;298MG/100ML;450MG/100ML N018362 003
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;300MG/100ML;900MG/100ML N019308 007 Apr 05, 1985
HOSPIRA 5GM/100ML;298MG/100ML;900MG/100ML N019691 009 Mar 24, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;150MG/100ML;450MG/100ML N018008 004
HOSPIRA 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 008 Mar 28, 1988
5GM/100ML;149MG/100ML;450MG/100ML N018362 004 Mar 28, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;150MG/100ML;900MG/100ML N019308 001 Apr 05, 1985
HOSPIRA 5GM/100ML;74.5MG/100ML;900MG/100ML N019691 001 Mar 24, 1988
5GM/100ML;149MG/100ML;900MG/100ML N019691 003 Mar 24, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 10GM/100ML;37MG/100ML;200MG/100ML N019630 031
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 10GM/100ML;37MG/100ML;450MG/100ML N019630 037
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 10GM/100ML;37MG/100ML;900MG/100ML N019630 043
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 5GM/100ML;37MG/100ML;110MG/100ML N019630 001
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 5GM/100ML;37MG/100ML;200MG/100ML N019630 007
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 5GM/100ML;37MG/100ML;330MG/100ML N019630 013
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 5GM/100ML;37MG/100ML;450MG/100ML N019630 019
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 5GM/100ML;37MG/100ML;900MG/100ML N019630 025
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 10GM/100ML;75MG/100ML;200MG/100ML N019630 032
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 10GM/100ML;75MG/100ML;450MG/100ML N019630 038
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 10GM/100ML;75MG/100ML;900MG/100ML N019630 044
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN May 07, 1992 3.3GM/100ML;75MG/100ML;300MG/100ML N019630 049
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN Feb 17, 1988 5GM/100ML;75MG/100ML;110MG/100ML N019630 002
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;110MG/100ML;200MG/100ML N019630 033 Feb 17, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-108( of 362)
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;110MG/100ML;450MG/100ML N019630 039 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;110MG/100ML;900MG/100ML N019630 045 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 3.3GM/100ML;110MG/100ML;300MG/100ML N019630 050 May 07, 1992
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML;110MG/100ML N019630 003 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML;200MG/100ML N019630 009 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML;330MG/100ML N019630 015 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML;450MG/100ML N019630 021 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML;900MG/100ML N019630 027 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;150MG/100ML;200MG/100ML N019630 034 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;150MG/100ML;450MG/100ML N019630 040 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;150MG/100ML;900MG/100ML N019630 046 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 3.3GM/100ML;150MG/100ML;300MG/100ML N019630 051 May 07, 1992
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;110MG/100ML N019630 004 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;220MG/100ML;200MG/100ML N019630 035 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;220MG/100ML;450MG/100ML N019630 041 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;220MG/100ML;900MG/100ML N019630 047 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 3.3GM/100ML;220MG/100ML;300MG/100ML N019630 052 May 07, 1992
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;110MG/100ML N019630 005 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;200MG/100ML N019630 011 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;330MG/100ML N019630 017 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;450MG/100ML N019630 023 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;900MG/100ML N019630 029 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;300MG/100ML;200MG/100ML N019630 036 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;300MG/100ML;450MG/100ML N019630 042 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;300MG/100ML;900MG/100ML N019630 048 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 3.3GM/100ML;300MG/100ML;300MG/100ML N019630 053 May 07, 1992
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;300MG/100ML;110MG/100ML N019630 006 Feb 17, 1988
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;74.5MG/100ML;225MG/100ML N018365 002 Jul 05, 1983
5GM/100ML;149MG/100ML;225MG/100ML N018365 006 Mar 28, 1988
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;74.5MG/100ML;300MG/100ML N018876 001 Jan 17, 1986
5GM/100ML;149MG/100ML;300MG/100ML N018876 006 Mar 28, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;224MG/100ML;225MG/100ML N018365 008 Mar 28, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;224MG/100ML;300MG/100ML N018876 007 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;149MG/100ML;225MG/100ML N018365 001
5GM/100ML;298MG/100ML;225MG/100ML N018365 009 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;298MG/100ML;300MG/100ML N018876 008 Mar 28, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-109( of 362)
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;149MG/100ML;300MG/100ML N018876 002 Jan 17, 1986
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;224MG/100ML;225MG/100ML N018365 003 Jul 05, 1983
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;224MG/100ML;300MG/100ML N018876 003 Jan 17, 1986
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;298MG/100ML;225MG/100ML N018365 004 Jul 05, 1983
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;298MG/100ML;300MG/100ML N018876 004 Mar 28, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;74.5MG/100ML;225MG/100ML N018365 005 Mar 28, 1988
5GM/100ML;149MG/100ML;225MG/100ML N018365 007 Mar 28, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;74.5MG/100ML;300MG/100ML
5GM/100ML;149MG/100ML;300MG/100ML
N018876 005
N018876 009
Mar 28, 1988
Mar 28, 1988
DEXTROSE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
AP
B BRAUN 10GM/100ML;900MG/100ML
BAXTER HLTHCARE 10GM/100ML;900MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
N019631 015 Feb 24, 1988
N016696 001
AP
AP
B BRAUN 2.5GM/100ML;450MG/100ML
BAXTER HLTHCARE 2.5GM/100ML;450MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
N019631 004 Feb 24, 1988
N016697 001
AP B BRAUN 5GM/100ML;200MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
N019631 007 Feb 24, 1988
AP B BRAUN 5GM/100ML;330MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
N019631 008 Feb 24, 1988
AP
AP
B BRAUN 5GM/100ML;450MG/100ML
HOSPIRA 5GM/100ML;450MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
N019631 009 Feb 24, 1988
N017607 001
AP
AP
B BRAUN 5GM/100ML;900MG/100ML
HOSPIRA 5GM/100ML;900MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
N019631 010 Feb 24, 1988
N017585 001
AP BAXTER HLTHCARE 5GM/100ML;200MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
N016689 001
AP BAXTER HLTHCARE 5GM/100ML;330MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
N016687 001
AP BAXTER HLTHCARE 5GM/100ML;450MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
N016683 001
AP BAXTER HLTHCARE 5GM/100ML;900MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
N016678 001
B BRAUN 10GM/100ML;110MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
N019631 011 Feb 24, 1988
B BRAUN 10GM/100ML;200MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
N019631 012 Feb 24, 1988
B BRAUN 10GM/100ML;330MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
N019631 013 Feb 24, 1988
B BRAUN 10GM/100ML;450MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
N019631 014 Feb 24, 1988
B BRAUN 2.5GM/100ML;110MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
N019631 001 Feb 24, 1988
B BRAUN 2.5GM/100ML;200MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
N019631 002 Feb 24, 1988
B BRAUN 2.5GM/100ML;330MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
N019631 003 Feb 24, 1988
B BRAUN 2.5GM/100ML;900MG/100ML
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
N019631 005 Feb 24, 1988
B BRAUN 3.3GM/100ML;300MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
N019631 016 Jan 19, 1990
B BRAUN 5GM/100ML;110MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
N019631 006 Feb 24, 1988
HOSPIRA 5GM/100ML;225MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
N017606 001
HOSPIRA 5GM/100ML;300MG/100ML N017799 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-110( of 362)
DIATRIZOATE MEGLUMINE
SOLUTION;URETHRAL
CYSTOGRAFIN
BRACCO 30% N010040 018
CYSTOGRAFIN DILUTE
BRACCO 18% N010040 022 Nov 09, 1982
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
INJECTABLE;INJECTION
MD-76R
AP + MALLINCKRODT 66%;10% N019292 001 Sep 29, 1989
RENOGRAFIN-76
AP + BRACCO 66%;10% N010040 001
SOLUTION;ORAL, RECTAL
GASTROGRAFIN
AA + BRACCO 66%;10% N011245 003
MD-GASTROVIEW
AA MALLINCKRODT 66%;10% A087388 001
DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE
SOLUTION;INTRAUTERINE
SINOGRAFIN
+ BRACCO 52.7%;26.8% N011324 002
DIAZEPAM
CONCENTRATE;ORAL
DIAZEPAM INTENSOL
+ ROXANE 5MG/ML A071415 001 Apr 03, 1987
GEL;RECTAL
DIASTAT
VALEANT 2.5MG/0.5ML (5MG/ML) N020648 001 Jul 29, 1997
DIASTAT ACUDIAL
VALEANT 10MG/2ML (5MG/ML) N020648 007 Sep 15, 2005
+ 20MG/4ML (5MG/ML) N020648 006 Sep 15, 2005
INJECTABLE;INJECTION
DIAZEPAM
AP + HOSPIRA 5MG/ML A071583 001 Oct 13, 1987
AP 5MG/ML A072079 001 Dec 20, 1988
SOLUTION;ORAL
DIAZEPAM
+ ROXANE 5MG/5ML A070928 001 Apr 03, 1987
TABLET;ORAL
DIAZEPAM
AB BARR 2MG A070152 001 Nov 01, 1985
AB 10MG A070154 001 Nov 01, 1985
AB DAVA PHARMS INC 2MG A070226 001 Sep 26, 1985
AB IVAX SUB TEVA PHARMS 2MG A071307 001 Dec 10, 1986
AB 5MG A071321 001 Dec 10, 1986
AB 10MG A071322 001 Dec 10, 1986
AB MYLAN 2MG A070325 002 Sep 04, 1985
AB 5MG A070325 003 Sep 04, 1985
AB 10MG A070325 001 Sep 04, 1985
AB VINTAGE PHARMS 2MG A077749 001 Mar 31, 2006
AB 5MG A077749 002 Mar 31, 2006
AB 10MG A077749 003 Mar 31, 2006
AB WATSON LABS 2MG A071134 001 Feb 03, 1987
AB 5MG A071135 001 Feb 03, 1987
AB 10MG A071136 001 Feb 03, 1987
VALIUM
AB ROCHE 2MG N013263 002
AB 5MG N013263 004
AB + 10MG N013263 006
DIAZOXIDE
SUSPENSION;ORAL
PROGLYCEM
+ TEVA BRANDED PHARM 50MG/ML N017453 001
DICLOFENAC
CAPSULE;ORAL
ZORVOLEX
IROKO PHARMS LLC 18MG N204592 001 Oct 18, 2013
+ 35MG N204592 002 Oct 18, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-111( of 362)
DICLOFENAC EPOLAMINE
PATCH;TOPICAL
FLECTOR
+ INST BIOCHEM 1.3% N021234 001 Jan 31, 2007
DICLOFENAC POTASSIUM
CAPSULE;ORAL
ZIPSOR
+ DEPOMED INC 25MG N022202 001 Jun 16, 2009
FOR SOLUTION;ORAL
CAMBIA
+ NAUTILUS NEUROSCIENC 50MG N022165 001 Jun 17, 2009
TABLET;ORAL
CATAFLAM
AB + NOVARTIS 50MG N020142 002 Nov 24, 1993
DICLOFENAC POTASSIUM
AB APOTEX 50MG A076561 001 Mar 18, 2004
AB MYLAN 50MG A075463 001 Jul 26, 1999
AB SANDOZ 50MG A075229 001 Nov 20, 1998
AB TEVA 50MG A075219 001 Aug 06, 1998
DICLOFENAC SODIUM
GEL;TOPICAL
DICLOFENAC SODIUM
AB TOLMAR 3% A200936 001 Oct 28, 2013
SOLARAZE
AB + FOUGERA PHARMS 3% N021005 001 Oct 16, 2000
VOLTAREN
+ NOVARTIS 1% N022122 001 Oct 17, 2007
SOLUTION;TOPICAL
PENNSAID
+ MALLINCKRODT 1.5% N020947 001 Nov 04, 2009
SOLUTION/DROPS;OPHTHALMIC
DICLOFENAC SODIUM
AT AKORN 0.1% A077845 001 Apr 17, 2008
AT ALCON PHARMS LTD 0.1% A078031 001 Feb 06, 2008
AT BAUSCH AND LOMB 0.1% A078792 001 Dec 28, 2007
AT NEXUS PHARMS 0.1% A078553 001 Dec 28, 2007
VOLTAREN
AT + NOVARTIS 0.1% N020037 001 Mar 28, 1991
TABLET, DELAYED RELEASE;ORAL
DICLOFENAC SODIUM
AB ACTAVIS ELIZABETH 50MG A074514 001 Mar 26, 1996
AB 75MG A074514 002 Mar 26, 1996
AB CARLSBAD 25MG A075185 002 Nov 13, 1998
AB 50MG A075185 003 Nov 13, 1998
AB 75MG A075185 001 Nov 13, 1998
AB MYLAN PHARMS INC 50MG A075281 002 Feb 12, 2002
AB 75MG A075281 003 Feb 12, 2002
AB + SANDOZ 25MG A074376 001 Sep 28, 1995
AB + 50MG A074376 002 Sep 28, 1995
AB + 75MG A074394 001 Nov 30, 1995
AB UNIQUE PHARM LABS 25MG A090066 001 Dec 01, 2010
AB 50MG A090066 002 Dec 01, 2010
AB 75MG A077863 003 Jun 08, 2007
TABLET, EXTENDED RELEASE;ORAL
DICLOFENAC SODIUM
AB ACTAVIS ELIZABETH 100MG A075910 001 Jan 07, 2002
AB DEXCEL LTD 100MG A076201 001 Nov 06, 2002
AB MYLAN 100MG A076152 001 Dec 13, 2001
AB VALEANT INTL 100MG A075492 001 Feb 11, 2000
VOLTAREN-XR
AB + NOVARTIS 100MG N020254 001 Mar 08, 1996
DICLOFENAC SODIUM; MISOPROSTOL
TABLET, DELAYED RELEASE;ORAL
ARTHROTEC
AB GD SEARLE LLC 50MG;0.2MG N020607 001 Dec 24, 1997
AB + 75MG;0.2MG N020607 002 Dec 24, 1997
DICLOFENAC SODIUM AND MISOPROSTOL
AB SANDOZ 50MG;0.2MG A200158 001 May 09, 2013
AB 75MG;0.2MG A200158 002 May 09, 2013
AB WATSON LABS INC 50MG;0.2MG A201089 001 Jul 09, 2012
AB 75MG;0.2MG A201089 002 Jul 09, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-112( of 362)
DICLOXACILLIN SODIUM
CAPSULE;ORAL
DICLOXACILLIN SODIUM
AB SANDOZ EQ 250MG BASE A061454 001
AB + EQ 500MG BASE A061454 003
AB TEVA EQ 250MG BASE A062286 001 Jun 03, 1982
AB EQ 500MG BASE A062286 002 Jun 03, 1982
SANDOZ EQ 125MG BASE A061454 002
DICYCLOMINE HYDROCHLORIDE
CAPSULE;ORAL
BENTYL
AB + APTALIS PHARMA US 10MG N007409 003 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE
AB LANNETT 10MG A084285 001
AB MYLAN 10MG A040319 001 Sep 07, 1999
AB WATSON LABS 10MG A085082 001 Jun 19, 1986
INJECTABLE;INJECTION
BENTYL
AP + APTALIS PHARMA US 10MG/ML N008370 001 Oct 15, 1984
BENTYL PRESERVATIVE FREE
AP + APTALIS PHARMA US 10MG/ML N008370 002 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE)
AP BEDFORD 10MG/ML A040465 001 Jun 30, 2003
SYRUP;ORAL
BENTYL
AA + APTALIS PHARMA US 10MG/5ML N007961 002 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE
AA MIKART 10MG/5ML A040169 001 Mar 24, 2005
TABLET;ORAL
BENTYL
AB + APTALIS PHARMA US 20MG N007409 001 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE
AB LANNETT 20MG A040230 001 Feb 26, 1999
AB MYLAN 20MG A040317 001 Sep 07, 1999
AB WATSON LABS 20MG A085223 001 Jul 30, 1986
DIDANOSINE
CAPSULE, DELAYED REL PELLETS;ORAL
DIDANOSINE
AB AUROBINDO PHARMA 125MG A090094 001 Sep 24, 2008
AB 200MG A090094 002 Sep 24, 2008
AB 250MG A090094 003 Sep 24, 2008
AB 400MG A090094 004 Sep 24, 2008
AB BARR 200MG A077167 001 Dec 03, 2004
AB 250MG A077167 002 Dec 03, 2004
AB 400MG A077167 003 Dec 03, 2004
AB MYLAN PHARMS INC 125MG A090788 001 Apr 08, 2010
AB 200MG A090788 002 Apr 08, 2010
AB 250MG A090788 003 Apr 08, 2010
AB 400MG A090788 004 Apr 08, 2010
VIDEX EC
AB BRISTOL MYERS SQUIBB 125MG N021183 001 Oct 31, 2000
AB 200MG N021183 002 Oct 31, 2000
AB 250MG N021183 003 Oct 31, 2000
AB + 400MG N021183 004 Oct 31, 2000
FOR SOLUTION;ORAL
DIDANOSINE
AA AUROBINDO PHARMA 10MG/ML A078112 001 Mar 08, 2007
VIDEX
AA + BRISTOL MYERS SQUIBB 10MG/ML N020156 001 Oct 09, 1991
TABLET, FOR SUSPENSION;ORAL
DIDANOSINE
AUROBINDO 100MG A077275 001 Aug 14, 2012
150MG A077275 002 Aug 14, 2012
+ 200MG A077275 003 Aug 14, 2012
DIENOGEST; ESTRADIOL VALERATE
TABLET;ORAL
NATAZIA
+ BAYER HLTHCARE 2MG;3MG;N/A;1MG;2MG;2MG;3MG;N/A N022252 001 May 06, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-113( of 362)
DIETHYLPROPION HYDROCHLORIDE
TABLET;ORAL
DIETHYLPROPION HYDROCHLORIDE
AA AVANTHI INC 25MG A201212 001 Dec 22, 2010
AA COREPHARMA 25MG A040828 001 Nov 05, 2008
AA LANNETT HOLDINGS INC 25MG A200177 001 Jul 18, 2011
TENUATE
AA + WATSON PHARMS 25MG N011722 002
TABLET, EXTENDED RELEASE;ORAL
DIETHYLPROPION HYDROCHLORIDE
AB LANNETT HOLDINGS INC 75MG A091680 001 Oct 24, 2011
TENUATE DOSPAN
AB + WATSON PHARMS 75MG N012546 001
DIFLORASONE DIACETATE
CREAM;TOPICAL
DIFLORASONE DIACETATE
BX + FOUGERA PHARMS 0.05% A076263 001 Dec 20, 2002
BX + TARO 0.05% A075508 001 Apr 24, 2000
OINTMENT;TOPICAL
DIFLORASONE DIACETATE
AB FOUGERA PHARMS 0.05% A075374 001 Apr 27, 1999
AB + TARO 0.05% A075331 001 May 14, 1999
DIFLUNISAL
TABLET;ORAL
DIFLUNISAL
AB EMCURE PHARMS USA 500MG A202845 001 Mar 08, 2012
AB + TEVA 500MG A073673 001 Jul 31, 1992
DIFLUPREDNATE
EMULSION;OPHTHALMIC
DUREZOL
+ ALCON PHARMS LTD 0.05% N022212 001 Jun 23, 2008
DIGOXIN
ELIXIR;ORAL
DIGOXIN
+ ROXANE 0.05MG/ML N021648 001 Aug 26, 2004
INJECTABLE;INJECTION
DIGOXIN
AP HIKMA MAPLE 0.25MG/ML A083391 001
AP SANDOZ 0.25MG/ML A040481 001 Aug 21, 2003
LANOXIN
AP + COVIS PHARMA 0.25MG/ML N009330 002
LANOXIN PEDIATRIC
+ COVIS PHARMA 0.1MG/ML N009330 004
TABLET;ORAL
DIGOXIN
AB HIKMA PHARMS 0.125MG A077002 002 Oct 30, 2007
AB 0.25MG A077002 001 Oct 30, 2007
AB IMPAX LABS 0.125MG A078556 001 Jul 20, 2009
AB 0.25MG A078556 002 Jul 20, 2009
AB STEVENS J 0.125MG A076268 001 Jul 26, 2002
AB 0.25MG A076268 002 Jul 26, 2002
LANOXIN
AB COVIS PHARMA 0.125MG N020405 002 Sep 30, 1997
AB + 0.25MG N020405 004 Sep 30, 1997
DIHYDROERGOTAMINE MESYLATE
INJECTABLE;INJECTION
D.H.E. 45
AP + VALEANT 1MG/ML N005929 001
DIHYDROERGOTAMINE MESYLATE
AP BEDFORD LABS 1MG/ML A040453 001 Jun 09, 2003
AP PADDOCK LLC 1MG/ML A040475 001 Apr 28, 2003
SPRAY, METERED;NASAL
MIGRANAL
+ VALEANT 0.5MG/INH N020148 001 Dec 08, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
DILACOR XR
AB2 WATSON LABS
AB2
AB2 +
DILTIAZEM HYDROCHLORIDE
AB2 APOTEX
AB2
AB2
AB2 MYLAN
AB2
AB2
AB2 WATSON LABS FLORIDA
AB2
AB2
CARDIZEM CD
AB3 VALEANT INTL
AB3
AB3
AB3
AB3 +
CARTIA XT
AB3 WATSON LABS FLORIDA
AB3
AB3
AB3
DILT-CD
AB3 APOTEX
AB3
AB3
AB3
DILTIAZEM HYDROCHLORIDE
AB3 ACTAVIS INC
AB3 PAR PHARM
AB3
AB3
AB3
AB3 SUN PHARMA GLOBAL
AB3
AB3
AB3
AB3
AB3 VALEANT INTL
AB3
AB3
AB3
AB4 NESHER PHARMS
AB4
AB4
AB4
AB4
AB4
AB4 SANDOZ
AB4
AB4
AB4
AB4
AB4
AB4 SUN PHARMA GLOBAL
AB4
AB4
AB4
AB4
DILTZAC
AB4 APOTEX INC
AB4
AB4
AB4
AB4
TAZTIA XT
AB4 WATSON LABS FLORIDA
120MG
180MG
240MG
120MG
180MG
240MG
120MG
180MG
240MG
120MG
180MG
240MG
120MG
180MG
240MG
300MG
360MG
120MG
180MG
240MG
300MG
120MG
180MG
240MG
300MG
360MG
120MG
180MG
240MG
300MG
120MG
180MG
240MG
300MG
360MG
120MG
180MG
240MG
300MG
120MG
180MG
240MG
300MG
360MG
420MG
120MG
180MG
240MG
300MG
360MG
420MG
120MG
180MG
240MG
300MG
360MG
120MG
180MG
240MG
300MG
360MG
120MG
3-114( of 362)
N020092 001 May 29, 1992
N020092 002 May 29, 1992
N020092 003 May 29, 1992
A074943 003 Dec 19, 2000
A074943 002 Dec 19, 2000
A074943 001 Aug 06, 1998
A075124 002 Mar 18, 1998
A075124 003 Mar 18, 1998
A075124 001 Mar 18, 1998
A074852 001 Oct 10, 1997
A074852 002 Oct 10, 1997
A074852 003 Oct 10, 1997
N020062 001 Aug 10, 1992
N020062 002 Dec 27, 1991
N020062 003 Dec 27, 1991
N020062 004 Dec 27, 1991
N020062 005 Aug 24, 1999
A074752 002 Jul 09, 1998
A074752 001 Jul 09, 1998
A074752 003 Jul 09, 1998
A074752 004 Jul 09, 1998
A076151 001 May 20, 2004
A076151 002 May 20, 2004
A076151 003 May 20, 2004
A076151 004 May 20, 2004
A202463 001 Dec 07, 2012
A074984 001 Dec 20, 1999
A074984 002 Dec 20, 1999
A074984 003 Dec 20, 1999
A074984 004 Dec 20, 1999
A090492 001 Oct 28, 2011
A090492 002 Oct 28, 2011
A090492 003 Oct 28, 2011
A090492 004 Oct 28, 2011
A090492 005 Oct 28, 2011
A075116 001 Dec 23, 1999
A075116 002 Dec 23, 1999
A075116 003 Dec 23, 1999
A075116 004 Dec 23, 1999
A076563 002 Sep 12, 2006
A076563 003 Sep 12, 2006
A076563 004 Sep 12, 2006
A076563 005 Sep 12, 2006
A076563 006 Sep 12, 2006
A076563 001 Sep 12, 2006
A091022 001 Sep 28, 2012
A091022 002 Sep 28, 2012
A091022 003 Sep 28, 2012
A091022 004 Sep 28, 2012
A091022 005 Sep 28, 2012
A091022 006 Sep 28, 2012
A090421 001 Nov 15, 2010
A090421 002 Nov 15, 2010
A090421 003 Nov 15, 2010
A090421 004 Nov 15, 2010
A090421 005 Nov 15, 2010
A076395 001 Feb 01, 2006
A076395 002 Feb 01, 2006
A076395 003 Feb 01, 2006
A076395 004 Feb 01, 2006
A076395 005 Feb 01, 2006
A075401 001 Apr 10, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-115( of 362)
DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
TAZTIA XT
AB4 180MG A075401 002 Apr 10, 2003
AB4 240MG A075401 003 Apr 10, 2003
AB4 300MG A075401 004 Apr 10, 2003
AB4 360MG A075401 005 Apr 10, 2003
TIAZAC
AB4 VALEANT INTL 120MG N020401 001 Sep 11, 1995
AB4 180MG N020401 002 Sep 11, 1995
AB4 240MG N020401 003 Sep 11, 1995
AB4 300MG N020401 004 Sep 11, 1995
AB4 360MG N020401 005 Sep 11, 1995
AB4 + 420MG N020401 006 Oct 16, 1998
DILTIAZEM HYDROCHLORIDE
BC + MYLAN 120MG A074910 003 May 02, 1997
60MG A074910 001 May 02, 1997
90MG A074910 002 May 02, 1997
INJECTABLE;INJECTION
DILTIAZEM HYDROCHLORIDE
AP AKORN INC 5MG/ML A075086 001 Apr 09, 1998
AP + BEDFORD 5MG/ML A074617 001 Feb 28, 1996
AP HIKMA FARMACEUTICA 5MG/ML A202651 001 Aug 09, 2012
AP HIKMA MAPLE 5MG/ML A078538 001 Dec 17, 2008
AP HOSPIRA 5MG/ML A074941 001 Apr 15, 1998
AP INTL MEDICATION 5MG/ML A075749 001 Nov 21, 2001
+ HOSPIRA 100MG/VIAL A075853 001 Dec 17, 2002
+ TEVA PHARMS USA 10MG/ML A074894 002 Apr 19, 2002
TABLET;ORAL
CARDIZEM
AB VALEANT INTL 30MG N018602 001 Nov 05, 1982
AB 60MG N018602 002 Nov 05, 1982
AB 90MG N018602 003 Dec 08, 1986
AB + 120MG N018602 004 Dec 08, 1986
DILTIAZEM HYDROCHLORIDE
AB MYLAN 30MG A072838 004 Nov 05, 1992
AB 60MG A072838 003 Nov 05, 1992
AB 90MG A072838 002 Nov 05, 1992
AB 120MG A072838 001 Nov 05, 1992
AB TEVA 30MG A074185 001 May 31, 1995
AB 60MG A074185 002 May 31, 1995
AB 90MG A074185 003 May 31, 1995
AB 120MG A074185 004 May 31, 1995
TABLET, EXTENDED RELEASE;ORAL
CARDIZEM LA
AB VALEANT INTL 120MG N021392 001 Feb 06, 2003
AB 180MG N021392 002 Feb 06, 2003
AB 240MG N021392 003 Feb 06, 2003
AB 300MG N021392 004 Feb 06, 2003
AB 360MG N021392 005 Feb 06, 2003
AB + 420MG N021392 006 Feb 06, 2003
DILTIAZEM HYDROCHLORIDE
AB WATSON LABS FLORIDA 120MG A077686 006 Mar 15, 2010
AB 180MG A077686 005 Mar 15, 2010
AB 240MG A077686 004 Mar 15, 2010
AB 300MG A077686 003 Mar 15, 2010
AB 360MG A077686 002 Mar 15, 2010
AB 420MG A077686 001 Mar 15, 2010
DIMENHYDRINATE
INJECTABLE;INJECTION
DIMENHYDRINATE
+ FRESENIUS KABI USA 50MG/ML A040519 001 Jun 23, 2004
DIMERCAPROL
INJECTABLE;INJECTION
BAL
+ AKORN 10% N005939 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-116( of 362)
DIMETHYL FUMARATE
CAPSULE, DELAYED RELEASE;ORAL
TECFIDERA
BIOGEN IDEC INC 120MG N204063 001 Mar 27, 2013
+ 240MG N204063 002 Mar 27, 2013
DIMETHYL SULFOXIDE
SOLUTION;INTRAVESICAL
DIMETHYL SULFOXIDE
AT MYLAN INSTITUTIONAL 50% A076185 001 Nov 29, 2002
RIMSO-50
AT + MYLAN INSTITUTIONAL 50% N017788 001
DINOPROSTONE
GEL;ENDOCERVICAL
PREPIDIL
+ PHARMACIA AND UPJOHN 0.5MG/3GM N019617 001 Dec 09, 1992
INSERT, EXTENDED RELEASE;VAGINAL
CERVIDIL
+ FERRING CONTROLLED 10MG N020411 001 Mar 30, 1995
SUPPOSITORY;VAGINAL
PROSTIN E2
+ PHARMACIA AND UPJOHN 20MG N017810 001
DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE;ORAL
DIPHENHYDRAMINE HYDROCHLORIDE
+ BARR 50MG A080738 001
ELIXIR;ORAL
DIPHENHYDRAMINE HYDROCHLORIDE
+ PHARM ASSOC 12.5MG/5ML A087513 001 Feb 10, 1982
INJECTABLE;INJECTION
DIPHENHYDRAMINE HYDROCHLORIDE
AP APP PHARMS 50MG/ML A040466 001 May 28, 2002
AP + HIKMA MAPLE 50MG/ML A080817 002
AP HOSPIRA 50MG/ML A040140 001 Nov 20, 1998
AP MYLAN INSTITUTIONAL 50MG/ML A040498 001 Jul 12, 2005
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
AP BD RX 50MG/ML A091526 001 Mar 26, 2013
AP INTL MEDICATION 50MG/ML A084094 001
DIPIVEFRIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AKPRO
AT AKORN 0.1% A074382 001 Sep 29, 1995
DIPIVEFRIN HYDROCHLORIDE
AT FALCON PHARMS 0.1% A073636 001 Jun 30, 1994
PROPINE
AT + ALLERGAN 0.1% N018239 001
DIPYRIDAMOLE
INJECTABLE;INJECTION
DIPYRIDAMOLE
AP + BEDFORD 5MG/ML A074939 001 Apr 13, 1998
AP FRESENIUS KABI USA 5MG/ML A074956 001 Sep 30, 1998
AP HIKMA MAPLE 5MG/ML A074521 001 Oct 18, 1996
TABLET;ORAL
DIPYRIDAMOLE
AB BARR 25MG A087184 001 Oct 03, 1990
AB 50MG A087716 001 Oct 03, 1990
AB 75MG A087717 001 Oct 03, 1990
AB GLENMARK GENERICS 25MG A088999 001 Feb 05, 1991
AB 50MG A089000 001 Feb 05, 1991
AB 75MG A089001 001 Feb 05, 1991
AB IMPAX LABS 25MG A040782 001 Jul 18, 2007
AB 50MG A040782 002 Jul 18, 2007
AB 75MG A040782 003 Jul 18, 2007
AB LANNETT 25MG A040898 001 Apr 23, 2008
AB 50MG A040898 002 Apr 23, 2008
AB 75MG A040898 003 Apr 23, 2008
AB MURTY PHARMS 25MG A040733 001 Feb 13, 2007
AB 50MG A040733 002 Feb 13, 2007
AB 75MG A040733 003 Feb 13, 2007
AB PUREPAC PHARM 25MG A089425 001 Jul 12, 1990
AB WATSON LABS 50MG A087160 001 Jun 07, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-117( of 362)
DIPYRIDAMOLE
TABLET;ORAL
DIPYRIDAMOLE
AB ZYDUS PHARMS USA INC 25MG A040874 001 Jan 28, 2008
AB 50MG A040874 002 Jan 28, 2008
AB 75MG A040874 003 Jan 28, 2008
PERSANTINE
AB BOEHRINGER INGELHEIM 25MG N012836 003 Dec 22, 1986
AB 50MG N012836 004 Feb 06, 1987
AB + 75MG N012836 005 Feb 06, 1987
DISOPYRAMIDE PHOSPHATE
CAPSULE;ORAL
DISOPYRAMIDE PHOSPHATE
AB TEVA EQ 100MG BASE A070101 001 Feb 22, 1985
AB EQ 150MG BASE A070102 001 Feb 22, 1985
AB WATSON LABS EQ 100MG BASE A070173 001 May 31, 1985
AB EQ 150MG BASE A070174 001 May 31, 1985
NORPACE
AB GD SEARLE LLC EQ 100MG BASE N017447 001
AB + EQ 150MG BASE N017447 002
CAPSULE, EXTENDED RELEASE;ORAL
NORPACE CR
AB + GD SEARLE LLC EQ 150MG BASE N018655 002 Jul 20, 1982
EQ 100MG BASE N018655 001 Jul 20, 1982
DISULFIRAM
TABLET;ORAL
ANTABUSE
AB ODYSSEY PHARMS 250MG A088482 001 Dec 08, 1983
AB + 500MG A088483 001 Dec 08, 1983
DISULFIRAM
AB SIGMAPHARM LABS LLC 250MG A091619 001 Mar 28, 2011
AB 500MG A091619 002 Mar 28, 2011
AB VINTAGE PHARMS 250MG A091563 001 Dec 31, 2012
AB 500MG A091563 002 Dec 31, 2012
DISULFIRAM
AB ALVOGEN PINE BROOK 250MG A091681 001 Aug 08, 2013
DIVALPROEX SODIUM
CAPSULE, DELAYED REL PELLETS;ORAL
DEPAKOTE
AB + ABBVIE EQ 125MG VALPROIC ACID N019680 001 Sep 12, 1989
DIVALPROEX SODIUM
AB DR REDDYS LABS LTD EQ 125MG VALPROIC ACID A078979 001 Jan 23, 2009
AB MYLAN EQ 125MG VALPROIC ACID A090407 001 Mar 28, 2011
AB ZYDUS PHARMS USA INC EQ 125MG VALPROIC ACID A078919 001 Jan 27, 2009
TABLET, DELAYED RELEASE;ORAL
DEPAKOTE
AB ABBVIE EQ 125MG VALPROIC ACID N018723 003 Oct 26, 1984
AB EQ 250MG VALPROIC ACID N018723 001 Mar 10, 1983
AB + EQ 500MG VALPROIC ACID N018723 002 Mar 10, 1983
DIVALPROEX SODIUM
AB ANCHEN PHARMS EQ 500MG VALPROIC ACID A078411 001 Nov 03, 2008
AB AUROBINDO PHARMA LTD EQ 125MG VALPROIC ACID A090554 001 Apr 21, 2011
AB EQ 250MG VALPROIC ACID A090554 002 Apr 21, 2011
AB EQ 500MG VALPROIC ACID A090554 003 Apr 21, 2011
AB DR REDDYS LABS LTD EQ 125MG VALPROIC ACID A078755 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078755 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078755 003 Jul 29, 2008
AB LUPIN EQ 125MG VALPROIC ACID A078790 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078790 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078790 003 Jul 29, 2008
AB MYLAN EQ 125MG VALPROIC ACID A090062 001 Mar 17, 2009
AB EQ 250MG VALPROIC ACID A090062 002 Mar 17, 2009
AB EQ 500MG VALPROIC ACID A090062 003 Mar 17, 2009
AB NU PHARM EQ 125MG VALPROIC ACID A077615 003 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A077615 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A077615 001 Jul 29, 2008
AB ORCHID HLTHCARE EQ 125MG VALPROIC ACID A078853 001 Nov 25, 2008
AB EQ 250MG VALPROIC ACID A078853 002 Nov 25, 2008
AB EQ 500MG VALPROIC ACID A078853 003 Nov 25, 2008
AB SANDOZ EQ 125MG VALPROIC ACID A078290 003 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078290 002 Jul 29, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-118( of 362)
DIVALPROEX SODIUM
TABLET, DELAYED RELEASE;ORAL
DIVALPROEX SODIUM
AB EQ 500MG VALPROIC ACID A078290 001 Jul 29, 2008
AB SUN PHARM INDS EQ 125MG VALPROIC ACID A078597 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078597 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078597 003 Jul 29, 2008
AB TEVA EQ 125MG VALPROIC ACID A076941 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A076941 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A076941 003 Jul 29, 2008
AB UNICHEM LABS LTD EQ 125MG VALPROIC ACID A079163 001 Apr 05, 2011
AB EQ 250MG VALPROIC ACID A079163 002 Apr 05, 2011
AB EQ 500MG VALPROIC ACID A079163 003 Apr 05, 2011
AB UPSHER SMITH EQ 125MG VALPROIC ACID A078182 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078182 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078182 003 Jul 29, 2008
AB VINTAGE EQ 125MG VALPROIC ACID A090210 001 Nov 30, 2009
AB EQ 250MG VALPROIC ACID A090210 002 Nov 30, 2009
AB EQ 500MG VALPROIC ACID A090210 003 Nov 30, 2009
AB WATSON LABS FLORIDA EQ 500MG VALPROIC ACID A079080 001 Feb 25, 2011
AB WOCKHARDT EQ 125MG VALPROIC ACID A077296 001 Jul 31, 2008
AB EQ 250MG VALPROIC ACID A077296 002 Jul 31, 2008
AB EQ 500MG VALPROIC ACID A077296 003 Jul 31, 2008
AB ZYDUS PHARMS USA INC EQ 125MG VALPROIC ACID A077100 001 Mar 05, 2009
AB EQ 250MG VALPROIC ACID A077100 002 Mar 05, 2009
AB EQ 500MG VALPROIC ACID A077100 003 Mar 05, 2009
TABLET, EXTENDED RELEASE;ORAL
DEPAKOTE ER
AB ABBVIE EQ 250MG VALPROIC ACID N021168 002 May 31, 2002
AB + EQ 500MG VALPROIC ACID N021168 001 Aug 04, 2000
DIVALPROEX SODIUM
AB ANCHEN PHARMS EQ 250MG VALPROIC ACID A078445 001 Feb 26, 2009
AB EQ 500MG VALPROIC ACID A078445 002 Aug 04, 2009
AB DR REDDYS LABS LTD EQ 250MG VALPROIC ACID A090161 001 Mar 15, 2012
AB IMPAX LABS EQ 250MG VALPROIC ACID A078791 001 May 06, 2009
AB EQ 500MG VALPROIC ACID A078791 002 Aug 04, 2009
AB MYLAN EQ 250MG VALPROIC ACID A077567 001 Jan 29, 2009
AB EQ 500MG VALPROIC ACID A077567 002 Jan 29, 2009
AB REDDYS EQ 500MG VALPROIC ACID A090070 001 Mar 12, 2012
AB WOCKHARDT EQ 250MG VALPROIC ACID A078705 002 Feb 10, 2009
AB EQ 500MG VALPROIC ACID A078705 001 Aug 04, 2009
AB ZYDUS PHARMS USA INC EQ 250MG VALPROIC ACID A078239 001 Feb 27, 2009
AB EQ 500MG VALPROIC ACID A078239 002 Aug 04, 2009
DOBUTAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOBUTAMINE HYDROCHLORIDE
AP BEDFORD EQ 12.5MG BASE/ML A074277 001 Oct 31, 1994
AP HOSPIRA EQ 12.5MG BASE/ML A074086 001 Nov 29, 1993
AP + EQ 12.5MG BASE/ML A074292 001 Feb 16, 1995
AP WATSON LABS EQ 12.5MG BASE/ML A074114 001 Nov 30, 1993
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
AP + HOSPIRA EQ 50MG BASE/100ML N020269 001 Oct 19, 1993
AP + EQ 100MG BASE/100ML N020269 002 Oct 19, 1993
AP + EQ 200MG BASE/100ML N020269 003 Oct 19, 1993
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE EQ 50MG BASE/100ML N020255 001 Oct 19, 1993
AP + EQ 100MG BASE/100ML N020255 003 Oct 19, 1993
AP + EQ 200MG BASE/100ML N020255 004 Oct 19, 1993
AP + EQ 400MG BASE/100ML N020255 005 Oct 19, 1993
AP + HOSPIRA EQ 50MG BASE/100ML N020201 003 Oct 19, 1993
AP + EQ 100MG BASE/100ML N020201 002 Oct 19, 1993
AP + EQ 200MG BASE/100ML N020201 001 Oct 19, 1993
AP + EQ 400MG BASE/100ML N020201 006 Jul 07, 1994
DOCETAXEL
INJECTABLE;INJECTION
DOCETAXEL
AP ACCORD HLTHCARE 20MG/0.5ML (40MG/ML) N201195 001 Jun 08, 2011
AP 20MG/ML (20MG/ML) N201195 003 Apr 20, 2012
AP 80MG/2ML (40MG/ML) N201195 002 Jun 08, 2011
AP 80MG/4ML (20MG/ML) N201195 004 Apr 20, 2012
AP 160MG/8ML (20MG/ML) N201195 005 Apr 20, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-119( of 362)
DOCETAXEL
INJECTABLE;INJECTION
DOCETAXEL
AP ACTAVIS INC 20MG/ML (20MG/ML) N203551 001 Apr 12, 2013
AP 80MG/4ML (20MG/ML) N203551 002 Apr 12, 2013
AP + HOSPIRA INC 20MG/2ML (10MG/ML) N022234 001 Mar 08, 2011
AP + 80MG/8ML (10MG/ML) N022234 002 Mar 08, 2011
AP + 160MG/16ML (10MG/ML) N022234 003 Mar 08, 2011
AP SANDOZ 20MG/2ML (10MG/ML) N201525 001 Jun 29, 2011
AP 80MG/8ML (10MG/ML) N201525 002 Jun 29, 2011
AP 160MG/16ML (10MG/ML) N201525 003 Jun 29, 2011
TAXOTERE
AP + SANOFI AVENTIS US 20MG/ML (20MG/ML) N020449 003 Aug 03, 2010
AP + 80MG/4ML (20MG/ML) N020449 004 Aug 02, 2010
AP + 160MG/8ML (20MG/ML) N020449 005 Apr 13, 2012
DOCEFREZ
+ SUN PHARMA GLOBAL 20MG/VIAL N022534 001 May 03, 2011
+ 80MG/VIAL N022534 002 May 03, 2011
DOCETAXEL
ACTAVIS INC 140MG/7ML (20MG/ML) N203551 003 Apr 12, 2013
DOFETILIDE
CAPSULE;ORAL
TIKOSYN
PFIZER 0.125MG N020931 001 Oct 01, 1999
0.25MG N020931 002 Oct 01, 1999
+ 0.5MG N020931 003 Oct 01, 1999
DOLASETRON MESYLATE
INJECTABLE;INJECTION
ANZEMET
+ SANOFI AVENTIS US 12.5MG/0.625ML (20MG/ML) N020624 002 Sep 11, 1997
+ 100MG/5ML (20MG/ML) N020624 001 Sep 11, 1997
+ 500MG/25ML (20MG/ML) N020624 003 Dec 11, 2001
TABLET;ORAL
ANZEMET
SANOFI AVENTIS US 50MG N020623 001 Sep 11, 1997
+ 100MG N020623 002 Sep 11, 1997
DOLUTEGRAVIR SODIUM
TABLET;ORAL
TIVICAY
+ VIIV HLTHCARE EQ 50MG BASE N204790 001 Aug 12, 2013
DONEPEZIL HYDROCHLORIDE
TABLET;ORAL
ARICEPT
AB EISAI INC 5MG N020690 002 Nov 25, 1996
AB + 10MG N020690 001 Nov 25, 1996
AB + 23MG N022568 001 Jul 23, 2010
DONEPEZIL HYDROCHLORIDE
AB ALEMBIC PHARMS LTD 5MG A201724 001 Feb 25, 2013
AB 10MG A201724 002 Feb 25, 2013
AB APOTEX 5MG A078841 001 Jun 02, 2011
AB 10MG A078841 002 Jun 02, 2011
AB AUROBINDO 5MG A090056 001 May 31, 2011
AB 10MG A090056 002 May 31, 2011
AB CIPLA LTD 5MG A077518 001 May 31, 2011
AB 10MG A077518 002 May 31, 2011
AB CSPC OUYI PHARM CO 5MG A202114 001 Jul 05, 2013
AB 10MG A202114 002 Jul 05, 2013
AB DR REDDYS LABS LTD 5MG A201001 001 May 31, 2011
AB 10MG A201001 002 May 31, 2011
AB 23MG A202723 001 Jul 24, 2013
AB HIKMA PHARMS 5MG A090247 001 May 31, 2011
AB 10MG A090247 002 May 31, 2011
AB INDICUS PHARMA 5MG A201634 001 Jun 13, 2012
AB 10MG A201634 002 Jun 13, 2012
AB JUBILANT LIFE 5MG A090768 001 May 31, 2011
AB 10MG A090768 002 May 31, 2011
AB MACLEODS PHARMS LTD 5MG A201146 001 Aug 17, 2012
AB 10MG A201146 002 Aug 17, 2012
AB MYLAN PHARMS INC 5MG A090521 001 May 31, 2011
AB 10MG A090521 002 May 31, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-120( of 362)
DONEPEZIL HYDROCHLORIDE
TABLET;ORAL
DONEPEZIL HYDROCHLORIDE
AB PAR PHARM 23MG A202542 001 Jul 24, 2013
AB PLIVA HRVATSKA DOO 5MG A090425 001 May 31, 2011
AB 10MG A090425 002 May 31, 2011
AB PRINSTON INC 5MG A200292 001 May 31, 2011
AB 10MG A200292 002 May 31, 2011
AB RANBAXY 5MG A076786 001 Nov 26, 2010
AB 10MG A076786 002 Nov 26, 2010
AB ROXANE 5MG A078662 001 May 31, 2011
AB 10MG A078662 002 May 31, 2011
AB SANDOZ 5MG A090290 001 May 31, 2011
AB 10MG A090290 002 May 31, 2011
AB SUN PHARM INDS 5MG A090493 001 May 31, 2011
AB 10MG A090493 002 May 31, 2011
AB TEVA 5MG A077344 001 May 31, 2011
AB 10MG A077344 002 May 31, 2011
AB TORRENT PHARMS 5MG A090686 001 May 31, 2011
AB 10MG A090686 002 May 31, 2011
AB VIVIMED LABS 5MG A090551 001 May 31, 2011
AB 10MG A090551 002 May 31, 2011
AB WOCKHARDT 5MG A091267 001 May 31, 2011
AB 10MG A091267 002 May 31, 2011
AB ZYDUS PHARMS USA INC 5MG A090100 001 Oct 24, 2012
AB 10MG A090100 002 Oct 24, 2012
TABLET, ORALLY DISINTEGRATING;ORAL
ARICEPT ODT
AB EISAI INC 5MG N021720 001 Oct 18, 2004
AB + 10MG N021720 002 Oct 18, 2004
DONEPEZIL HYDROCHLORIDE
AB BARR 5MG A078388 002 Nov 26, 2010
AB 10MG A078388 001 Nov 26, 2010
AB MACLEODS PHARMS LTD 5MG A201787 001 Dec 14, 2012
AB 10MG A201787 002 Dec 14, 2012
AB SANDOZ 5MG A091198 001 May 10, 2011
AB 10MG A091198 002 May 10, 2011
AB ZYDUS PHARMS USA INC 5MG A090175 001 May 10, 2011
AB 10MG A090175 002 May 10, 2011
DOPAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOPAMINE HYDROCHLORIDE
AP + HOSPIRA 40MG/ML N018132 001
AP + 80MG/100ML N018132 002 Feb 04, 1982
AP + 80MG/ML N018132 004 Jul 09, 1982
AP + 160MG/100ML N018132 003 Feb 04, 1982
AP + LUITPOLD 40MG/ML A070799 001 Feb 11, 1987
AP + 80MG/ML A070820 001 Feb 11, 1987
AP + 160MG/ML A070826 001 Feb 11, 1987
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%
AP + B BRAUN 80MG/100ML N019099 002 Oct 15, 1986
AP + 320MG/100ML N019099 004 Oct 15, 1986
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 160MG/100ML N019099 003 Oct 15, 1986
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 80MG/100ML N019615 001 Mar 27, 1987
AP + 160MG/100ML N019615 002 Mar 27, 1987
AP + 320MG/100ML N019615 003 Mar 27, 1987
AP + HOSPIRA 80MG/100ML N018826 001 Sep 30, 1983
AP + 160MG/100ML N018826 002 Sep 30, 1983
AP + 320MG/100ML N018826 003 Sep 30, 1983
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
+ B BRAUN 40MG/100ML N019099 001 Oct 15, 1986
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 640MG/100ML N019615 004 Mar 27, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-121( of 362)
DORIPENEM
INJECTABLE;IV (INFUSION)
DORIBAX
SHIONOGI INC 250MG/VIAL N022106 002 Oct 05, 2010
+ 500MG/VIAL N022106 001 Oct 12, 2007
DORZOLAMIDE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
DORZOLAMIDE HYDROCHLORIDE
AT ALCON PHARMS LTD EQ 2% BASE A078981 001 Apr 13, 2009
AT BAUSCH AND LOMB EQ 2% BASE A090143 001 Jun 25, 2009
AT HI TECH PHARMA EQ 2% BASE A077846 001 Oct 28, 2008
AT LUITPOLD EQ 2% BASE A079186 001 Nov 18, 2009
AT SANDOZ EQ 2% BASE A078748 001 Nov 06, 2008
AT TEVA PHARMS EQ 2% BASE A078756 001 Dec 04, 2008
AT ZACH SYSTEMS EQ 2% BASE A091034 001 Dec 04, 2013
TRUSOPT
AT + MERCK EQ 2% BASE N020408 001 Dec 09, 1994
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC
COSOPT
AT + OAK PHARMS AKORN EQ 2% BASE;EQ 0.5% BASE N020869 001 Apr 07, 1998
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
AT ALCON RES EQ 2% BASE;EQ 0.5% BASE A090604 001 Nov 18, 2009
AT BAUSCH AND LOMB EQ 2% BASE;EQ 0.5% BASE A090037 001 Jul 14, 2009
AT HI TECH PHARMA EQ 2% BASE;EQ 0.5% BASE A077847 001 Oct 28, 2008
AT SANDOZ EQ 2% BASE;EQ 0.5% BASE A078749 001 Nov 06, 2008
AT TEVA PHARMS EQ 2% BASE;EQ 0.5% BASE A078704 001 Sep 28, 2009
AT ZACH SYSTEMS EQ 2% BASE;EQ 0.5% BASE A091180 001 Dec 04, 2013
COSOPT PF
+ OAK PHARMS AKORN EQ 2% BASE;EQ 0.5% BASE N202667 001 Feb 01, 2012
DOXAPRAM HYDROCHLORIDE
INJECTABLE;INJECTION
DOPRAM
AP + HIKMA MAPLE 20MG/ML N014879 001
DOXAPRAM HYDROCHLORIDE
AP BEDFORD 20MG/ML A076266 001 Jan 10, 2003
AP WATSON LABS 20MG/ML A073529 001 Jan 30, 1992
DOXAZOSIN MESYLATE
TABLET;ORAL
CARDURA
AB + PFIZER EQ 1MG BASE N019668 001 Nov 02, 1990
AB EQ 2MG BASE N019668 002 Nov 02, 1990
AB EQ 4MG BASE N019668 003 Nov 02, 1990
AB EQ 8MG BASE N019668 004 Nov 02, 1990
DOXAZOSIN MESYLATE
AB APOTEX EQ 1MG BASE A075580 001 Oct 18, 2000
AB EQ 2MG BASE A075580 002 Oct 18, 2000
AB EQ 4MG BASE A075580 003 Oct 18, 2000
AB EQ 8MG BASE A075580 004 Oct 18, 2000
AB DAVA PHARMS INC EQ 1MG BASE A076161 001 Jun 10, 2004
AB EQ 2MG BASE A076161 002 Jun 10, 2004
AB EQ 4MG BASE A076161 003 Jun 10, 2004
AB EQ 8MG BASE A076161 004 Jun 10, 2004
AB MYLAN EQ 1MG BASE A075509 001 Oct 19, 2000
AB EQ 2MG BASE A075509 002 Oct 19, 2000
AB EQ 4MG BASE A075509 003 Oct 19, 2000
AB EQ 8MG BASE A075509 004 Oct 19, 2000
AB PLIVA EQ 1MG BASE A075750 001 Jun 08, 2001
AB EQ 2MG BASE A075750 002 Jun 08, 2001
AB EQ 4MG BASE A075750 003 Jun 08, 2001
AB EQ 8MG BASE A075750 004 Jun 08, 2001
AB TEVA EQ 1MG BASE A075536 001 Oct 18, 2000
AB EQ 2MG BASE A075536 002 Oct 18, 2000
AB EQ 4MG BASE A075536 003 Oct 18, 2000
AB EQ 8MG BASE A075536 004 Oct 18, 2000
TABLET, EXTENDED RELEASE;ORAL
CARDURA XL
PFIZER EQ 4MG BASE N021269 001 Feb 22, 2005
+ EQ 8MG BASE N021269 002 Feb 22, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-122( of 362)
DOXEPIN HYDROCHLORIDE
CAPSULE;ORAL
DOXEPIN HYDROCHLORIDE
AB MYLAN PHARMS INC EQ 10MG BASE A070791 002 May 13, 1986
AB + EQ 25MG BASE A070791 003 May 13, 1986
AB EQ 50MG BASE A070791 001 May 13, 1986
AB EQ 75MG BASE A070791 004 May 13, 1986
AB EQ 100MG BASE A070791 005 May 13, 1986
PAR PHARM EQ 150MG BASE A071669 001 Nov 09, 1987
CONCENTRATE;ORAL
DOXEPIN HYDROCHLORIDE
AA SILARX EQ 10MG BASE/ML A074721 001 Dec 29, 1998
AA + TEVA PHARMS EQ 10MG BASE/ML A071609 001 Nov 09, 1987
AA WOCKHARDT EQ 10MG BASE/ML A071918 001 Jul 20, 1988
CREAM;TOPICAL
ZONALON
+ FOUGERA PHARMS 5% N020126 001 Apr 01, 1994
TABLET;ORAL
DOXEPIN HYDROCHLORIDE
AB ACTAVIS ELIZABETH EQ 3MG BASE A201951 001 Jul 26, 2013
AB EQ 6MG BASE A201951 002 Jul 26, 2013
SILENOR
AB PERNIX THERAPS LLC EQ 3MG BASE N022036 001 Mar 17, 2010
AB + EQ 6MG BASE N022036 002 Mar 17, 2010
DOXERCALCIFEROL
CAPSULE;ORAL
DOXERCALCIFEROL
AB ROXANE 0.5MCG A091433 001 Sep 23, 2011
AB 1MCG A091433 002 Jan 14, 2014
AB 2.5MCG A091433 003 Jan 14, 2014
HECTOROL
AB GENZYME CORP 0.5MCG N020862 002 Apr 23, 2004
AB 1MCG N020862 003 Jul 13, 2009
AB + 2.5MCG N020862 001 Jun 09, 1999
INJECTABLE;INJECTION
DOXERCALCIFEROL
AP HIKMA PHARMS LLC 4MCG/2ML (2MCG/ML) A091101 001 Aug 30, 2013
HECTOROL
AP + GENZYME CORP 4MCG/2ML (2MCG/ML) N021027 001 Apr 06, 2000
2MCG/ML (2MCG/ML) N021027 002 Apr 06, 2000
DOXORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
DOXORUBICIN HYDROCHLORIDE
AP ALVOGEN INC 2MG/ML A065515 001 Nov 08, 2012
AP + BEDFORD 2MG/ML A062975 001 Mar 17, 1989
AP + 10MG/VIAL A062921 001 Mar 17, 1989
AP + 20MG/VIAL A062921 002 Mar 17, 1989
AP + 50MG/VIAL A062921 003 Mar 17, 1989
AP + 200MG/100ML A064097 001 Sep 13, 1994
AP FRESENIUS KABI USA 2MG/ML A063277 001 Oct 26, 1995
AP ONCO THERAPIES LTD 2MG/ML A200901 001 Feb 14, 2012
AP 10MG/VIAL A200170 001 Oct 28, 2011
AP 50MG/VIAL A200170 002 Oct 28, 2011
AP PHARMACHEMIE 2MG/ML A063336 001 Feb 28, 1995
AP 10MG/VIAL A063097 001 May 21, 1990
AP 20MG/VIAL A063097 002 May 21, 1990
AP 50MG/VIAL A063097 003 May 21, 1990
AP 200MG/100ML A063336 004 Feb 28, 1995
AP SAGENT PHARMS 2MG/ML A091495 001 Mar 18, 2013
AP SANDOZ INC 2MG/ML A200146 001 Jul 18, 2012
AP SUN PHARM INDS 2MG/ML A091418 001 Feb 15, 2012
AP TEVA PHARMS USA 2MG/ML A064140 001 Jul 28, 1995
AP 200MG/100ML A064140 002 Jul 28, 1995
INJECTABLE, LIPOSOMAL;INJECTION
DOXIL (LIPOSOMAL)
AB JANSSEN RES AND DEV 20MG/10ML (2MG/ML) N050718 001 Nov 17, 1995
AB 50MG/25ML (2MG/ML) N050718 002 Jun 13, 2000
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
AB + SUN PHARMA GLOBAL 20MG/10ML (2MG/ML) A203263 001 Feb 04, 2013
AB + 50MG/25ML (2MG/ML) A203263 002 Feb 04, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-123( of 362)
DOXYCYCLINE
CAPSULE;ORAL
DOXYCYCLINE
AB IMPAX LABS INC EQ 150MG BASE A200065 001 Feb 17, 2011
AB MYLAN 40MG A090855 001 Jul 01, 2010
AB MYLAN PHARMS INC EQ 150MG BASE A202778 001 Jun 08, 2012
AB PAR PHARM EQ 50MG BASE A065055 001 Dec 01, 2000
AB EQ 100MG BASE A065055 002 Dec 01, 2000
AB + EQ 150MG BASE A065055 003 Jul 15, 2005
AB RANBAXY EQ 50MG BASE A065053 001 Nov 22, 2000
AB EQ 75MG BASE A065053 003 Sep 10, 2003
AB EQ 100MG BASE A065053 002 Nov 22, 2000
AB WATSON LABS EQ 50MG BASE A065041 001 Apr 28, 2000
AB EQ 100MG BASE A065041 002 Apr 28, 2000
MONODOX
AB AQUA PHARMS EQ 50MG BASE N050641 002 Feb 10, 1992
AB EQ 75MG BASE N050641 003 Oct 18, 2006
AB + EQ 100MG BASE N050641 001 Dec 29, 1989
ORACEA
AB + GALDERMA LABS LP 40MG N050805 001 May 26, 2006
FOR SUSPENSION;ORAL
DOXYCYCLINE
AB CHARTWELL LIFE SCI EQ 25MG BASE/5ML A065454 001 Jul 16, 2008
AB LUPIN LTD EQ 25MG BASE/5ML A201678 001 Mar 18, 2013
VIBRAMYCIN
AB + PFIZER EQ 25MG BASE/5ML N050006 001
TABLET;ORAL
DOXYCYCLINE
AB HERITAGE PHARMS INC EQ 50MG BASE A091605 001 Dec 20, 2011
AB EQ 75MG BASE A091605 002 Dec 20, 2011
AB EQ 100MG BASE A091605 003 Dec 20, 2011
AB EQ 150MG BASE A091605 004 Dec 20, 2011
AB LANNETT EQ 50MG BASE A065285 001 Dec 08, 2005
AB EQ 75MG BASE A065285 003 Jul 30, 2008
AB EQ 100MG BASE A065285 002 Dec 08, 2005
AB EQ 150MG BASE A065285 004 Jul 30, 2008
AB MYLAN EQ 50MG BASE A065377 001 Nov 07, 2006
AB EQ 75MG BASE A065377 002 Nov 07, 2006
AB EQ 100MG BASE A065377 003 Nov 07, 2006
AB EQ 150MG BASE A065427 001 Jun 07, 2007
AB PAR PHARM EQ 50MG BASE A065070 001 Dec 15, 2000
AB EQ 75MG BASE A065070 003 Dec 30, 2002
AB EQ 100MG BASE A065070 002 Dec 15, 2000
AB + EQ 150MG BASE A065070 004 Jul 14, 2005
AB RANBAXY EQ 50MG BASE A065356 001 May 31, 2006
AB EQ 75MG BASE A065356 002 May 31, 2006
AB EQ 100MG BASE A065356 003 May 31, 2006
DOXYCYCLINE CALCIUM
SUSPENSION;ORAL
VIBRAMYCIN
+ PFIZER EQ 50MG BASE/5ML N050480 001
DOXYCYCLINE HYCLATE
CAPSULE;ORAL
DOXYCYCLINE HYCLATE
AB CHARTWELL LIFE SCI EQ 50MG BASE A062500 001 Sep 11, 1984
AB EQ 100MG BASE A062500 002 Sep 11, 1984
AB HIKMA PHARMS EQ 50MG BASE A062396 002 Nov 07, 1984
AB EQ 100MG BASE A062396 001 May 07, 1984
AB MUTUAL PHARM EQ 50MG BASE A062675 001 Jul 10, 1986
AB EQ 100MG BASE A062676 001 Jul 10, 1986
AB WATSON LABS FLORIDA EQ 50MG BASE A062031 002 Oct 13, 1982
AB EQ 100MG BASE A062031 001
VIBRAMYCIN
AB PFIZER EQ 50MG BASE N050007 001
AB + EQ 100MG BASE N050007 002
DOXYCYCLINE HYCLATE
+ WEST WARD EQ 20MG BASE A065103 001 May 13, 2005
CAPSULE, DELAYED RELEASE;ORAL
DOXYCYCLINE HYCLATE
MEDICIS EQ 75MG BASE A065281 001 Dec 21, 2005
+ EQ 100MG BASE A065281 002 Dec 21, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-124( of 362)
DOXYCYCLINE HYCLATE
INJECTABLE;INJECTION
DOXY 100
AP + FRESENIUS KABI USA EQ 100MG BASE/VIAL A062475 001 Dec 09, 1983
DOXYCYCLINE
AP AGILA SPECLTS EQ 100MG BASE/VIAL A091406 001 Aug 21, 2012
AP + BEDFORD EQ 100MG BASE/VIAL A062569 001 Mar 09, 1988
DOXY 200
+ FRESENIUS KABI USA EQ 200MG BASE/VIAL A062475 002 Dec 09, 1983
SYSTEM, EXTENDED RELEASE;PERIODONTAL
ATRIDOX
+ TOLMAR 50MG N050751 001 Sep 03, 1998
TABLET;ORAL
DOXYCYCLINE HYCLATE
AB BLU CARIBE INC EQ 100MG BASE A062269 002 Nov 08, 1982
AB CHARTWELL LIFE SCI EQ 100MG BASE A062505 001 Sep 11, 1984
AB COREPHARMA EQ 20MG BASE A065182 001 May 13, 2005
AB + HIKMA PHARMS EQ 100MG BASE A065095 001 Jul 02, 2003
AB IVAX SUB TEVA PHARMS EQ 20MG BASE A065163 001 May 13, 2005
AB LANNETT EQ 20MG BASE A065277 001 Nov 10, 2005
AB LARKEN LABS EQ 20MG BASE A065287 001 Feb 28, 2006
AB MUTUAL PHARM EQ 100MG BASE A062677 001 Jul 10, 1986
AB MUTUAL PHARMA EQ 20MG BASE A065134 001 May 13, 2005
AB VINTAGE PHARMS EQ 100MG BASE A062538 001 Apr 07, 1986
AB WATSON LABS INC FL EQ 100MG BASE A062421 001 Feb 02, 1983
PERIOSTAT
AB + GALDERMA LABS LP EQ 20MG BASE N050783 001 Feb 02, 2001
TABLET, DELAYED RELEASE;ORAL
DORYX
AB MAYNE PHARMA EQ 75MG BASE N050795 001 May 06, 2005
AB EQ 100MG BASE N050795 002 May 06, 2005
AB + EQ 150MG BASE N050795 003 Jun 20, 2008
DOXYCYCLINE HYCLATE
AB ACTAVIS ELIZABETH EQ 75MG BASE A090134 001 Dec 14, 2011
AB EQ 100MG BASE A090134 002 Dec 14, 2011
AB HERITAGE PHARMS INC EQ 75MG BASE A200856 001 Apr 30, 2013
AB EQ 100MG BASE A200856 002 Apr 30, 2013
AB EQ 150MG BASE A200856 003 Apr 30, 2013
AB IMPAX LABS INC EQ 75MG BASE A090505 001 Dec 28, 2010
AB EQ 100MG BASE A090505 002 Dec 28, 2010
AB MYLAN EQ 75MG BASE A090431 001 Dec 28, 2010
AB EQ 100MG BASE A090431 002 Dec 28, 2010
AB MYLAN PHARMS INC EQ 150MG BASE A091052 001 Feb 08, 2012
DORYX
MAYNE PHARMA EQ 80MG BASE N050795 004 Apr 11, 2013
EQ 200MG BASE N050795 005 Apr 11, 2013
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
TABLET, DELAYED RELEASE;ORAL
DICLEGIS
+ DUCHESNAY 10MG;10MG N021876 001 Apr 08, 2013
DRONABINOL
CAPSULE;ORAL
DRONABINOL
AB INSYS THERAP 2.5MG A078501 001 Aug 19, 2011
AB 5MG A078501 002 Aug 19, 2011
AB 10MG A078501 003 Aug 19, 2011
AB SVC PHARMA 2.5MG A078292 001 Jun 27, 2008
AB 5MG A078292 002 Jun 27, 2008
AB 10MG A078292 003 Jun 27, 2008
MARINOL
AB ABBVIE 2.5MG N018651 001 May 31, 1985
AB + 5MG N018651 002 May 31, 1985
AB 10MG N018651 003 May 31, 1985
DRONEDARONE HYDROCHLORIDE
TABLET;ORAL
MULTAQ
+ SANOFI AVENTIS US EQ 400MG BASE N022425 001 Jul 01, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-125( of 362)
DROPERIDOL
INJECTABLE;INJECTION
DROPERIDOL
AP HOSPIRA 2.5MG/ML A071981 001 Feb 29, 1988
AP LUITPOLD 2.5MG/ML A072123 001 Oct 24, 1988
INAPSINE
AP + AKORN INC 2.5MG/ML N016796 001
DROSPIRENONE; ESTRADIOL
TABLET;ORAL
ANGELIQ
BAYER HLTHCARE 0.25MG;0.5MG N021355 001 Feb 29, 2012
+ 0.5MG;1MG N021355 002 Sep 28, 2005
DROSPIRENONE; ETHINYL ESTRADIOL
TABLET;ORAL
DROSPIRENONE AND ETHINYL ESTRADIOL
AB BARR 3MG;0.02MG A078515 001 Mar 30, 2009
AB WATSON LABS 3MG;0.02MG A078833 001 Nov 28, 2011
LORYNA
AB SANDOZ 3MG;0.02MG A079221 001 Mar 28, 2011
YAZ
AB + BAYER HLTHCARE 3MG;0.02MG N021676 001 Mar 16, 2006
TABLET;ORAL-28
DROSPIRENONE AND ETHINYL ESTRADIOL
AB BARR 3MG;0.03MG A077527 001 May 09, 2008
AB LUPIN LTD 3MG;0.03MG A201663 001 Dec 18, 2012
AB WATSON LABS 3MG;0.03MG A090081 001 Sep 07, 2010
SYEDA
AB SANDOZ 3MG;0.03MG A090114 001 Mar 28, 2011
YASMIN
AB + BAYER HLTHCARE 3MG;0.03MG N021098 001 May 11, 2001
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
TABLET;ORAL
BEYAZ
+ BAYER HLTHCARE 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG N022532 001 Sep 24, 2010
SAFYRAL
BAYER HLTHCARE 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG N022574 001 Dec 16, 2010
DULOXETINE HYDROCHLORIDE
CAPSULE, DELAYED REL PELLETS;ORAL
CYMBALTA
AB LILLY EQ 20MG BASE N021427 001 Aug 03, 2004
AB EQ 30MG BASE N021427 002 Aug 03, 2004
AB + EQ 60MG BASE N021427 004 Aug 03, 2004
DULOXETINE HYDROCHLORIDE
AB ACTAVIS ELIZABETH EQ 20MG BASE A090776 001 Dec 17, 2013
AB EQ 30MG BASE A090776 002 Dec 17, 2013
AB EQ 60MG BASE A090776 003 Dec 17, 2013
AB AUROBINDO PHARMA LTD EQ 20MG BASE A090778 001 Dec 11, 2013
AB EQ 30MG BASE A090778 002 Dec 11, 2013
AB EQ 60MG BASE A090778 003 Dec 11, 2013
AB DR REDDYS LABS LTD EQ 20MG BASE A090723 001 Dec 11, 2013
AB EQ 30MG BASE A090723 002 Dec 11, 2013
AB EQ 60MG BASE A090723 003 Dec 11, 2013
AB LUPIN LTD EQ 20MG BASE A090694 001 Dec 11, 2013
AB EQ 30MG BASE A090694 002 Dec 11, 2013
AB EQ 60MG BASE A090694 004 Dec 11, 2013
AB SUN PHARMA GLOBAL EQ 20MG BASE A090745 001 Dec 11, 2013
AB EQ 30MG BASE A090745 002 Dec 11, 2013
AB EQ 60MG BASE A090745 003 Dec 11, 2013
AB TEVA PHARMS USA EQ 20MG BASE A090783 001 Dec 11, 2013
AB EQ 30MG BASE A090783 002 Dec 11, 2013
AB EQ 60MG BASE A090783 003 Dec 11, 2013
AB TORRENT PHARMS LTD EQ 20MG BASE A090774 001 Dec 11, 2013
AB EQ 30MG BASE A090774 002 Dec 11, 2013
AB EQ 60MG BASE A090774 003 Dec 11, 2013
AB ZYDUS PHARMS USA INC EQ 20MG BASE A090728 001 Jan 08, 2014
AB EQ 20MG BASE A090739 001 Jan 08, 2014
AB EQ 30MG BASE A090728 002 Jan 08, 2014
AB EQ 30MG BASE A090739 002 Jan 08, 2014
AB EQ 60MG BASE A090728 003 Jan 08, 2014
AB EQ 60MG BASE A090739 003 Jan 08, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
DULOXETINE HYDROCHLORIDE
CAPSULE, DELAYED REL PELLETS;ORAL
DULOXETINE HYDROCHLORIDE
LUPIN LTD EQ 40MG BASE
DUTASTERIDE
CAPSULE;ORAL
AVODART
AB + GLAXOSMITHKLINE 0.5MG
DUTASTERIDE
AB BANNER PHARMACAPS 0.5MG
AB BARR 0.5MG
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
CAPSULE;ORAL
JALYN
+ GLAXOSMITHKLINE
DYPHYLLINE
TABLET;ORAL
LUFYLLIN
MEDA PHARMS
+
ECHOTHIOPHATE IODIDE
FOR SOLUTION;OPHTHALMIC
PHOSPHOLINE IODIDE
+ WYETH PHARMS INC
ECONAZOLE NITRATE
AEROSOL, FOAM;TOPICAL
ECOZA
+ AMDERMA PHARMS
CREAM;TOPICAL
ECONAZOLE NITRATE
AB + FOUGERA PHARMS
AB IGI LABS INC
AB PERRIGO NEW YORK
AB TARO
EDETATE CALCIUM DISODIUM
INJECTABLE;INJECTION
CALCIUM DISODIUM VERSENATE
+ MEDICIS
EDROPHONIUM CHLORIDE
INJECTABLE;INJECTION
ENLON
AP MYLAN INSTITUTIONAL
TENSILON
AP + VALEANT PHARMS
TENSILON PRESERVATIVE FREE
AP + VALEANT PHARMS
EFAVIRENZ
CAPSULE;ORAL
SUSTIVA
BRISTOL MYERS SQUIBB
+
TABLET;ORAL
SUSTIVA
+ BRISTOL MYERS SQUIBB
0.5MG;0.4MG
200MG
400MG
0.125%
1%
1%
1%
1%
1%
200MG/ML
10MG/ML
10MG/ML
10MG/ML
50MG
200MG
600MG
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
TABLET;ORAL
ATRIPLA
+ GILEAD
EFLORNITHINE HYDROCHLORIDE
CREAM;TOPICAL
VANIQA
+ SKINMEDICA
600MG;200MG;300MG
13.9%
3-126( of 362)
A090694 003 Dec 11, 2013
N021319 001 Nov 20, 2001
A200899 001 May 30, 2013
A090095 001 Dec 21, 2010
N022460 001 Jun 14, 2010
A084566 001
A084566 002
N011963 001
N205175 001 Oct 24, 2013
A076075 001 Nov 26, 2002
A076574 001 Dec 17, 2004
A076479 001 Jun 23, 2004
A076005 001 Nov 26, 2002
N008922 001
A088873 001 Aug 06, 1985
N007959 001
N007959 002
N020972 001 Sep 17, 1998
N020972 003 Sep 17, 1998
N021360 002 Feb 01, 2002
N021937 001 Jul 12, 2006
N021145 001 Jul 27, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
ELETRIPTAN HYDROBROMIDE
TABLET;ORAL
RELPAX
PFIZER IRELAND
+
ELTROMBOPAG OLAMINE
TABLET;ORAL
PROMACTA
GLAXOSMITHKLINE
+
EMEDASTINE DIFUMARATE
SOLUTION/DROPS;OPHTHALMIC
EMADINE
+ ALCON
EMTRICITABINE
CAPSULE;ORAL
EMTRIVA
+ GILEAD
SOLUTION;ORAL
EMTRIVA
+ GILEAD
EQ 20MG BASE
EQ 40MG BASE
EQ 12.5MG ACID
EQ 25MG ACID
EQ 50MG ACID
EQ 75MG ACID
EQ 100MG ACID
0.05%
200MG
10MG/ML
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
TABLET;ORAL
COMPLERA
+ GILEAD SCIENCES INC 200MG;EQ 25MG BASE;300MG
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
TABLET;ORAL
TRUVADA
+ GILEAD
ENALAPRIL MALEATE
FOR SOLUTION;ORAL
EPANED KIT
+ SILVERGATE PHARMS
TABLET;ORAL
ENALAPRIL MALEATE
AB APOTEX
AB
AB
AB
AB MYLAN
AB
AB
AB
AB TARO
AB
AB
AB
AB TEVA
AB
AB
AB
AB WATSON LABS
AB
AB
AB
AB WOCKHARDT USA
AB
AB
AB
VASOTEC
AB VALEANT INTL
AB
AB
AB +
200MG;300MG
1MG/ML
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
3-127( of 362)
N021016 001 Dec 26, 2002
N021016 002 Dec 26, 2002
N022291 004 Oct 20, 2011
N022291 001 Nov 20, 2008
N022291 002 Nov 20, 2008
N022291 003 Sep 08, 2009
N022291 005 Nov 16, 2012
N020706 001 Dec 29, 1997
N021500 001 Jul 02, 2003
N021896 001 Sep 28, 2005
N202123 001 Aug 10, 2011
N021752 001 Aug 02, 2004
N204308 001 Aug 13, 2013
A075178 002 Mar 23, 2001
A075178 001 Mar 23, 2001
A075178 003 Mar 23, 2001
A075178 004 Mar 23, 2001
A075480 001 Aug 22, 2000
A075480 002 Aug 22, 2000
A075480 003 Aug 22, 2000
A075480 004 Aug 22, 2000
A075657 001 Jan 23, 2001
A075657 002 Jan 23, 2001
A075657 003 Jan 23, 2001
A075657 004 Jan 23, 2001
A075479 001 Aug 22, 2000
A075479 002 Aug 22, 2000
A075479 003 Aug 22, 2000
A075479 004 Aug 22, 2000
A075501 001 Aug 22, 2000
A075501 002 Aug 22, 2000
A075501 003 Aug 22, 2000
A075501 004 Aug 22, 2000
A075483 001 Aug 22, 2000
A075483 002 Aug 22, 2000
A075483 003 Aug 22, 2000
A075483 004 Aug 22, 2000
N018998 005 Jul 26, 1988
N018998 001 Dec 24, 1985
N018998 002 Dec 24, 1985
N018998 003 Dec 24, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
AB APOTEX INC
AB
AB DR REDDYS LABS LTD
AB
AB MYLAN
AB
AB TARO PHARM INDS
AB
AB TEVA
AB
VASERETIC
AB VALEANT INTL
AB +
ENALAPRILAT
INJECTABLE;INJECTION
ENALAPRILAT
AP + BEDFORD
AP HIKMA FARMACEUTICA
AP + HOSPIRA
AP TEVA PHARMS USA
ENFLURANE
LIQUID;INHALATION
ENFLURANE
AN PIRAMAL CRITICAL
ETHRANE
AN + BAXTER HLTHCARE
ENFUVIRTIDE
INJECTABLE;SUBCUTANEOUS
FUZEON
+ ROCHE
ENOXAPARIN SODIUM
5MG;12.5MG
10MG;25MG
5MG;12.5MG
10MG;25MG
5MG;12.5MG
10MG;25MG
5MG;12.5MG
10MG;25MG
5MG;12.5MG
10MG;25MG
5MG;12.5MG
10MG;25MG
1.25MG/ML
1.25MG/ML
1.25MG/ML
1.25MG/ML
99.9%
99.9%
90MG/VIAL
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
INJECTABLE;SUBCUTANEOUS
ENOXAPARIN SODIUM
AB SANDOZ INC
LOVENOX
300MG/3ML (100MG/ML)
AB SANOFI AVENTIS US 300MG/3ML (100MG/ML)
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
AP AMPHASTAR PHARM
AP
AP
AP
AP
AP
AP
AP SANDOZ
AP
AP
AP
AP
AP
AP
AP
LOVENOX (PRESERVATIVE FREE)
SANOFI AVENTIS US
AP
AP
AP
AP +
AP
AP
ENTACAPONE
TABLET;ORAL
COMTAN
AB + ORION PHARMA
ENTACAPONE
AB MYLAN PHARMS INC
AB SUN PHARMA GLOBAL
30MG/0.3ML (100MG/ML)
40MG/0.4ML (100MG/ML)
60MG/0.6ML (100MG/ML)
80MG/0.8ML (100MG/ML)
100MG/ML (100MG/ML)
120MG/0.8ML (150MG/ML)
150MG/ML (150MG/ML)
30MG/0.3ML (100MG/ML)
40MG/0.4ML (100MG/ML)
60MG/0.6ML (100MG/ML)
80MG/0.8ML (100MG/ML)
100MG/ML (100MG/ML)
120MG/0.8ML (150MG/ML)
150MG/ML (150MG/ML)
30MG/0.3ML (100MG/ML)
40MG/0.4ML (100MG/ML)
60MG/0.6ML (100MG/ML)
80MG/0.8ML (100MG/ML)
100MG/ML (100MG/ML)
120MG/0.8ML (150MG/ML)
150MG/ML (150MG/ML)
200MG
200MG
200MG
3-128( of 362)
A076486 001 Oct 27, 2004
A076486 002 Oct 27, 2004
A075909 001 Oct 15, 2001
A075909 002 Oct 15, 2001
A075624 001 Sep 18, 2001
A075624 002 Sep 18, 2001
A075788 001 Sep 18, 2001
A075788 002 Sep 18, 2001
A075727 001 Sep 18, 2001
A075727 002 Sep 18, 2001
N019221 003 Jul 12, 1995
N019221 001 Oct 31, 1986
A075634 001 Aug 22, 2000
A078687 001 Dec 23, 2008
A075458 001 Aug 22, 2000
A075578 001 Aug 22, 2000
A074396 001 Jul 29, 1994
N017087 001
N021481 001 Mar 13, 2003
A078660 001 Nov 28, 2011
N020164 009 Jan 23, 2003
A076684 001 Sep 19, 2011
A076684 002 Sep 19, 2011
A076684 003 Sep 19, 2011
A076684 004 Sep 19, 2011
A076684 005 Sep 19, 2011
A076684 006 Sep 19, 2011
A076684 007 Sep 19, 2011
A077857 002 Jul 23, 2010
A077857 003 Jul 23, 2010
A077857 004 Jul 23, 2010
A077857 005 Jul 23, 2010
A077857 001 Jul 23, 2010
A077857 006 Jul 23, 2010
A077857 007 Jul 23, 2010
N020164 001 Mar 29, 1993
N020164 002 Jan 30, 1998
N020164 003 Mar 27, 1998
N020164 004 Mar 27, 1998
N020164 005 Mar 27, 1998
N020164 007 Jun 02, 2000
N020164 008 Jun 02, 2000
N020796 001 Oct 19, 1999
A202394 001 May 13, 2013
A090690 001 Jul 16, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-129( of 362)
ENTACAPONE
TABLET;ORAL
ENTACAPONE
AB WOCKHARDT LTD 200MG A078941 001 Aug 16, 2012
ENTECAVIR
SOLUTION;ORAL
BARACLUDE
+ BRISTOL MYERS SQUIBB 0.05MG/ML N021798 001 Mar 29, 2005
TABLET;ORAL
BARACLUDE
BRISTOL MYERS SQUIBB 0.5MG N021797 001 Mar 29, 2005
+ 1MG N021797 002 Mar 29, 2005
ENZALUTAMIDE
CAPSULE;ORAL
XTANDI
+ ASTELLAS 40MG N203415 001 Aug 31, 2012
EPINASTINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
ELESTAT
AT + ALLERGAN 0.05% N021565 001 Oct 16, 2003
EPINASTINE HYDROCHLORIDE
AT APOTEX 0.05% A090919 001 Oct 31, 2011
AT BRECKENRIDGE PHARM 0.05% A090870 001 Mar 14, 2011
AT LUITPOLD 0.05% A090951 001 Oct 31, 2011
AT SUN PHARM INDS 0.05% A091626 001 Oct 31, 2011
EPINEPHRINE
INJECTABLE;INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS
ADRENALIN
+ JHP PHARMS 1MG/ML N204200 001 Dec 07, 2012
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
ADRENACLICK
BX + AMEDRA PHARMS EQ 0.15MG/DELIVERY N020800 003 Nov 25, 2009
BX + EQ 0.3MG/DELIVERY N020800 004 Nov 25, 2009
AUVI-Q
BX + SANOFI AVENTIS US EQ 0.15MG/DELIVERY N201739 002 Aug 10, 2012
BX EQ 0.3MG/DELIVERY N201739 001 Aug 10, 2012
EPIPEN
BX + MYLAN SPECLT 0.3MG/DELIVERY N019430 001 Dec 22, 1987
EPIPEN JR.
BX + MYLAN SPECLT 0.15MG/DELIVERY N019430 002 Dec 22, 1987
TWINJECT 0.15
BX + AMEDRA PHARMS EQ 0.15MG/DELIVERY N020800 002 May 28, 2004
TWINJECT 0.3
BX + AMEDRA PHARMS EQ 0.3MG/DELIVERY N020800 001 May 30, 2003
ADRENALIN
+ JHP PHARMS LLC 30MG/30ML (1MG/ML) N204640 001 Dec 18, 2013
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
LIGNOSPAN FORTE
+ DEPROCO EQ 0.02MG BASE/ML;2% A088389 001 Jan 22, 1985
LIGNOSPAN STANDARD
+ DEPROCO EQ 0.01MG BASE/ML;2% A088390 001 Jan 22, 1985
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CITANEST FORTE DENTAL
AP + DENTSPLY PHARM 0.005MG/ML;4% N021383 001
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
AP SEPTODONT INC 0.005MG/ML;4% A078959 001 Aug 30, 2011
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
AP EASTMAN KODAK 0.01MG/ML;2% A040057 002 Feb 26, 1993
AP 0.02MG/ML;2% A040057 001 Feb 26, 1993
AP HOSPIRA 0.005MG/ML;0.5% A089635 001 Jun 21, 1988
AP 0.005MG/ML;1.5% A088571 001 Sep 13, 1985
AP 0.005MG/ML;1.5% A089645 001 Jun 21, 1988
AP 0.005MG/ML;2% A089651 001 Jun 21, 1988
AP 0.01MG/ML;1% A089644 001 Jun 21, 1988
AP 0.01MG/ML;2% A078772 001 May 12, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-130( of 362)
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
AP 0.01MG/ML;2% A089646 001 Jun 21, 1988
AP 0.02MG/ML;2% A078772 002 May 12, 2008
OCTOCAINE
AP + SEPTODONT 0.01MG/ML;2% A084048 001
AP + 0.02MG/ML;2% A084048 002
XYLOCAINE W/ EPINEPHRINE
AP + FRESENIUS KABI USA 0.005MG/ML;0.5% N006488 012
AP + 0.005MG/ML;1% N006488 018 Nov 13, 1986
AP + 0.005MG/ML;1.5% N006488 017
AP + 0.005MG/ML;2% N006488 019 Nov 13, 1986
AP + 0.01MG/ML;1% N006488 004
AP + 0.02MG/ML;2% N006488 005
EPIRUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
ELLENCE
AP + PFIZER INC 200MG/100ML (2MG/ML) N050778 001 Sep 15, 1999
AP 50MG/25ML (2MG/ML) N050778 002 Sep 15, 1999
EPIRUBICIN HYDROCHLORIDE
AP ACTAVIS TOTOWA 10MG/5ML (2MG/ML) A065445 001 Sep 18, 2008
AP 50MG/25ML (2MG/ML) A065445 002 Sep 18, 2008
AP 200MG/100ML (2MG/ML) A065445 003 Sep 18, 2008
AP AKORN INC 50MG/25ML (2MG/ML) A090163 001 Jun 24, 2009
AP BEDFORD 50MG/25ML (2MG/ML) A065289 001 Jun 27, 2007
AP 200MG/100ML (2MG/ML) A065289 002 Jun 27, 2007
AP CIPLA LTD 50MG/25ML (2MG/ML) A065361 001 Oct 22, 2007
AP 200MG/100ML (2MG/ML) A065361 002 Oct 22, 2007
AP EBEWE PHARMA 50MG/25ML (2MG/ML) A065339 001 Dec 22, 2009
AP 200MG/100ML (2MG/ML) A065339 002 Dec 22, 2009
AP FRESENIUS KABI ONCOL 200MG/100ML (2MG/ML) A065411 001 Aug 20, 2007
AP 50MG/25ML (2MG/ML) A065411 002 Aug 20, 2007
AP FRESENIUS KABI USA 10MG/5ML (2MG/ML) A065408 001 Oct 15, 2007
AP 50MG/25ML (2MG/ML) A065408 002 Oct 15, 2007
AP 150MG/75ML (2MG/ML) A065408 003 Oct 15, 2007
AP 200MG/100ML (2MG/ML) A065408 004 Oct 15, 2007
AP HISUN PHARM HANGZHOU 50MG/25ML (2MG/ML) A090075 001 Mar 25, 2010
AP 200MG/100ML (2MG/ML) A090075 002 Mar 25, 2010
AP HOSPIRA 10MG/5ML (2MG/ML) A065343 001 Apr 19, 2007
AP 50MG/25ML (2MG/ML) A065343 002 Apr 19, 2007
AP 150MG/75ML (2MG/ML) A065343 003 Apr 19, 2007
AP 200MG/100ML (2MG/ML) A065343 004 Apr 19, 2007
AP MUSTAFA NEVSAT 50MG/25ML (2MG/ML) A090266 001 Apr 15, 2011
AP 200MG/100ML (2MG/ML) A090266 002 Apr 15, 2011
AP ONCO THERAPIES LTD 50MG/25ML (2MG/ML) A091599 001 Mar 12, 2012
AP 200MG/100ML (2MG/ML) A091599 002 Mar 12, 2012
AP TEVA PHARMS USA 50MG/25ML (2MG/ML) A065331 001 Aug 09, 2007
AP 200MG/100ML (2MG/ML) A065331 002 Aug 09, 2007
INJECTABLE;IV (INFUSION)
EPIRUBICIN HYDROCHLORIDE
+ HOSPIRA 50MG/VIAL N050807 001 Sep 15, 2006
EPLERENONE
TABLET;ORAL
EPLERENONE
AB APOTEX 25MG A078482 001 Jul 30, 2008
AB 50MG A078482 002 Jul 30, 2008
AB SANDOZ 25MG A078510 001 Aug 01, 2008
AB 50MG A078510 002 Aug 01, 2008
INSPRA
AB GD SEARLE LLC 25MG N021437 001 Sep 27, 2002
AB + 50MG N021437 002 Sep 27, 2002
EPOPROSTENOL SODIUM
INJECTABLE;INJECTION
EPOPROSTENOL SODIUM
AP TEVA PHARMS USA EQ 0.5MG BASE/VIAL A078396 001 Apr 23, 2008
AP EQ 1.5MG BASE/VIAL A078396 002 Apr 23, 2008
FLOLAN
AP + GLAXOSMITHKLINE LLC EQ 0.5MG BASE/VIAL N020444 001 Sep 20, 1995
AP + EQ 1.5MG BASE/VIAL N020444 002 Sep 20, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-131( of 362)
EPOPROSTENOL SODIUM
INJECTABLE;INJECTION
VELETRI
ACTELION PHARMS LTD EQ 0.5MG BASE/VIAL N022260 002 Jun 28, 2012
+ EQ 1.5MG BASE/VIAL N022260 001 Jun 27, 2008
EPROSARTAN MESYLATE
TABLET;ORAL
EPROSARTAN MESYLATE
AB MYLAN PHARMS INC EQ 400MG BASE A202012 001 Nov 16, 2011
AB EQ 600MG BASE A202012 002 Nov 16, 2011
TEVETEN
AB ABBVIE EQ 400MG BASE N020738 005 Dec 22, 1997
AB + EQ 600MG BASE N020738 006 May 27, 1999
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
TEVETEN HCT
ABBVIE 600MG;12.5MG N021268 001 Nov 01, 2001
+ 600MG;25MG N021268 002 Nov 01, 2001
EPTIFIBATIDE
INJECTABLE;INJECTION
INTEGRILIN
+ SCHERING 2MG/ML N020718 001 May 18, 1998
+ 75MG/100ML N020718 002 May 18, 1998
ERGOCALCIFEROL
CAPSULE;ORAL
DRISDOL
AA + SANOFI AVENTIS US 50,000 IU N003444 001
ERGOCALCIFEROL
AA ORIT LABS LLC 50,000 IU A040833 001 May 20, 2009
AA SIGMAPHARM LABS LLC 50,000 IU A091004 001 Jul 14, 2010
AA STRIDES ARCOLAB LTD 50,000 IU A090455 001 Aug 03, 2010
AA SUN PHARM INDS INC 50,000 IU A040865 001 Dec 29, 2009
VITAMIN D
AA BANNER PHARMACAPS 50,000 IU A080704 001
ERGOLOID MESYLATES
TABLET;ORAL
ERGOLOID MESYLATES
AB MUTUAL PHARM 1MG A081113 001 Oct 31, 1991
HYDERGINE
AB + NOVARTIS 1MG N017993 001
TABLET;SUBLINGUAL
ERGOLOID MESYLATES
WATSON LABS 0.5MG A087233 001
ERGOTAMINE TARTRATE
TABLET;SUBLINGUAL
ERGOMAR
+ ROSEDALE THERAPEUTIC 2MG A087693 001 Feb 24, 1983
ERIBULIN MESYLATE
SOLUTION;INTRAVENOUS
HALAVEN
+ EISAI INC 1MG/2ML (0.5MG/ML) N201532 001 Nov 15, 2010
ERLOTINIB HYDROCHLORIDE
TABLET;ORAL
TARCEVA
OSI PHARMS EQ 25MG BASE N021743 001 Nov 18, 2004
EQ 100MG BASE N021743 002 Nov 18, 2004
+ EQ 150MG BASE N021743 003 Nov 18, 2004
ERTAPENEM SODIUM
INJECTABLE;INTRAMUSCULAR, IV (INFUSION)
INVANZ
+ MERCK SHARP DOHME EQ 1GM BASE/VIAL N021337 001 Nov 21, 2001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-132( of 362)
ERYTHROMYCIN
CAPSULE, DELAYED REL PELLETS;ORAL
ERYC
AB + MAYNE PHARMA 250MG N050536 001
ERYTHROMYCIN
AB ARBOR PHARMS INC 250MG A062746 001 Dec 22, 1986
GEL;TOPICAL
ERYGEL
AT + DELCOR ASSET CORP 2% N050617 001 Oct 21, 1987
ERYTHROMYCIN
AT FOUGERA PHARMS 2% A064184 001 Sep 30, 1997
AT PERRIGO 2% A063211 001 Jan 29, 1993
OINTMENT;OPHTHALMIC
ERYTHROMYCIN
AT AKORN 0.5% A064030 001 Jul 18, 1996
AT BAUSCH AND LOMB 0.5% A064067 001 Jul 29, 1994
AT + PERRIGO CO TENNESSEE 0.5% A062447 001 Sep 26, 1983
OINTMENT;TOPICAL
AKNE-MYCIN
+ DOW PHARM 2% N050584 001 Jan 10, 1985
SOLUTION;TOPICAL
C-SOLVE-2
AT FOUGERA PHARMS 2% A062468 001 Jul 03, 1985
ERYTHRA-DERM
AT PADDOCK LLC 2% A062687 001 Feb 05, 1988
ERYTHRO-STATIN
AT HI TECH PHARMA 2% A064101 001 Oct 22, 1996
ERYTHROMYCIN
AT + FOUGERA PHARMS 2% A064187 001 Sep 30, 1997
AT PERRIGO NEW YORK 2% A063038 001 Jan 11, 1991
AT WOCKHARDT 2% A062825 001 Oct 23, 1987
SWAB;TOPICAL
ERYTHROMYCIN
AT + FOUGERA PHARMS 2% A065320 001 Jul 25, 2006
AT + PERRIGO 2% A064126 001 Jul 03, 1996
AT VERSAPHARM 2% A090215 001 May 12, 2010
TABLET;ORAL
ERYTHROMYCIN
ARBOR PHARMS INC 250MG A061621 001
+ 500MG A061621 002
TABLET, COATED PARTICLES;ORAL
PCE
ARBOR PHARMS INC 333MG N050611 001 Sep 09, 1986
+ 500MG N050611 002 Aug 22, 1990
TABLET, DELAYED RELEASE;ORAL
ERY-TAB
+ ARBOR PHARMS INC 250MG A062298 001
+ 333MG A062298 003 Mar 29, 1982
+ 500MG A062298 002
ERYTHROMYCIN ETHYLSUCCINATE
GRANULE;ORAL
E.E.S.
AB ARBOR PHARMS INC EQ 200MG BASE/5ML N050207 001
ERYPED
AB ARBOR PHARMS INC EQ 200MG BASE/5ML N050207 003 Mar 30, 1987
+ EQ 400MG BASE/5ML N050207 002
SUSPENSION;ORAL
E.E.S. 200
AB ARBOR PHARMS INC EQ 200MG BASE/5ML A061639 001
E.E.S. 400
AB + ARBOR PHARMS INC EQ 400MG BASE/5ML A061639 002
PEDIAMYCIN
AB ARBOR PHARMS INC EQ 200MG BASE/5ML A062304 001
PEDIAMYCIN 400
AB ARBOR PHARMS INC EQ 400MG BASE/5ML A062304 002
TABLET;ORAL
E.E.S. 400
BX + ARBOR PHARMS INC EQ 400MG BASE A061905 002 Aug 12, 1982
ERYTHROMYCIN ETHYLSUCCINATE
BX + ARBOR PHARMS INC EQ 400MG BASE A061904 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-133( of 362)
ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL
GRANULE;ORAL
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
+ BARR EQ 200MG BASE/5ML;EQ 600MG BASE/5ML A062759 001 May 20, 1988
ERYTHROMYCIN LACTOBIONATE
INJECTABLE;INJECTION
ERYTHROCIN
AP + HOSPIRA EQ 1GM BASE/VIAL A062638 002 Oct 31, 1986
AP EQ 500MG BASE/VIAL A062638 001 Oct 31, 1986
AP + EQ 500MG BASE/VIAL N050609 001 Sep 24, 1986
ERYTHROMYCIN STEARATE
TABLET;ORAL
ERYTHROCIN STEARATE
+ ARBOR PHARMS INC EQ 250MG BASE A060359 001
ESCITALOPRAM OXALATE
SOLUTION;ORAL
ESCITALOPRAM OXALATE
AA AMNEAL PHARMS EQ 5MG BASE/5ML A202227 001 Mar 14, 2012
AA AUROBINDO PHARMA LTD EQ 5MG BASE/5ML A079062 001 Apr 02, 2012
AA HETERO LABS LTD III EQ 5MG BASE/5ML A202221 001 Jun 12, 2012
AA SILARX PHARMS INC EQ 5MG BASE/5ML A090477 001 Jun 12, 2013
AA TARO EQ 5MG BASE/5ML A079121 001 May 03, 2012
LEXAPRO
AA + FOREST LABS EQ 5MG BASE/5ML N021365 001 Nov 27, 2002
TABLET;ORAL
ESCITALOPRAM OXALATE
AB ACCORD HLTHCARE EQ 5MG BASE A202389 001 Sep 11, 2012
AB EQ 10MG BASE A202389 002 Sep 11, 2012
AB EQ 20MG BASE A202389 003 Sep 11, 2012
AB APOTEX INC EQ 5MG BASE A078777 001 Sep 11, 2012
AB EQ 10MG BASE A078777 002 Sep 11, 2012
AB EQ 20MG BASE A078777 003 Sep 11, 2012
AB AUROBINDO PHARMA LTD EQ 5MG BASE A090432 001 Sep 11, 2012
AB EQ 10MG BASE A090432 002 Sep 11, 2012
AB EQ 20MG BASE A090432 003 Sep 11, 2012
AB HIKMA PHARMS EQ 5MG BASE A078766 001 Sep 11, 2012
AB EQ 10MG BASE A078766 002 Sep 11, 2012
AB EQ 20MG BASE A078766 003 Sep 11, 2012
AB INVAGEN PHARMS EQ 5MG BASE A078604 001 Sep 11, 2012
AB EQ 10MG BASE A078604 002 Sep 11, 2012
AB EQ 20MG BASE A078604 003 Sep 11, 2012
AB IVAX SUB TEVA PHARMS EQ 5MG BASE A076765 001 Mar 14, 2012
AB EQ 10MG BASE A076765 002 Mar 14, 2012
AB EQ 20MG BASE A076765 003 Mar 14, 2012
AB JUBILANT ORGANOSYS EQ 5MG BASE A202280 001 Sep 12, 2012
AB EQ 10MG BASE A202280 002 Sep 12, 2012
AB EQ 20MG BASE A202280 003 Sep 12, 2012
AB LUPIN LTD EQ 5MG BASE A078169 001 Sep 11, 2012
AB EQ 10MG BASE A078169 002 Sep 11, 2012
AB EQ 20MG BASE A078169 003 Sep 11, 2012
AB MACLEODS PHARMS LTD EQ 5MG BASE A202210 001 Sep 11, 2012
AB EQ 10MG BASE A202210 002 Sep 11, 2012
AB EQ 20MG BASE A202210 003 Sep 11, 2012
AB STI PHARMA LLC EQ 5MG BASE A077512 001 Sep 12, 2012
AB EQ 10MG BASE A077512 002 Sep 12, 2012
AB EQ 20MG BASE A077512 003 Sep 12, 2012
AB TORRENT PHARMS LTD EQ 5MG BASE A090939 001 Sep 11, 2012
AB EQ 10MG BASE A090939 002 Sep 11, 2012
AB EQ 20MG BASE A090939 003 Sep 11, 2012
AB ZYDUS PHARMS USA INC EQ 5MG BASE A077734 001 Sep 11, 2012
AB EQ 10MG BASE A077734 002 Sep 11, 2012
AB EQ 20MG BASE A077734 003 Sep 11, 2012
LEXAPRO
AB FOREST LABS EQ 5MG BASE N021323 001 Aug 14, 2002
AB EQ 10MG BASE N021323 002 Aug 14, 2002
AB + EQ 20MG BASE N021323 003 Aug 14, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
ESLICARBAZEPINE ACETATE
TABLET;ORAL
APTIOM
SUNOVION PHARMS INC
+
ESMOLOL HYDROCHLORIDE
INJECTABLE;INJECTION
BREVIBLOC
AP + BAXTER HLTHCARE
ESMOLOL HYDROCHLORIDE
AP BEDFORD LABS
AP FRESENIUS KABI USA
AP MYLAN INSTITUTIONAL
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 2GM/100ML
BREVIBLOC IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 1GM/100ML
ESOMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED REL PELLETS;ORAL
NEXIUM
ASTRAZENECA EQ 20MG BASE
+ EQ 40MG BASE
FOR SUSPENSION, DELAYED RELEASE;ORAL
NEXIUM
ASTRAZENECA EQ 2.5MG BASE/PACKET
EQ 5MG BASE/PACKET
EQ 10MG BASE/PACKET
EQ 20MG BASE/PACKET
+ EQ 40MG BASE/PACKET
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
TABLET, DELAYED RELEASE;ORAL
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
200MG
400MG
600MG
800MG
10MG/ML
10MG/ML
10MG/ML
10MG/ML
AB DR REDDYS LABS LTD
AB
VIMOVO
AB HORIZON PHARMA
AB +
ESOMEPRAZOLE SODIUM
INJECTABLE;INTRAVENOUS
ESOMEPRAZOLE SODIUM
AP SUN PHARMA GLOBAL
AP
NEXIUM IV
AP + ASTRAZENECA
AP +
ESOMEPRAZOLE STRONTIUM
CAPSULE, DELAYED RELEASE;ORAL
ESOMEPRAZOLE STRONTIUM
HANMI PHARM CO LTD
+
ESTAZOLAM
TABLET;ORAL
ESTAZOLAM
AB PAR PHARM
AB
AB TEVA
AB +
AB WATSON LABS
AB
ESTRADIOL
CREAM;VAGINAL
ESTRACE
+ WARNER CHILCOTT US
EQ 20MG BASE;375MG
EQ 20MG BASE;500MG
EQ 20MG BASE;375MG
EQ 20MG BASE;500MG
EQ 20MG BASE/VIAL
EQ 40MG BASE/VIAL
EQ 20MG BASE/VIAL
EQ 40MG BASE/VIAL
EQ 20MG BASE
EQ 40MG BASE
1MG
2MG
1MG
2MG
1MG
2MG
0.01%
FILM, EXTENDED RELEASE;TRANSDERMAL
CLIMARA
AB BAYER HLTHCARE 0.0375MG/24HR
AB 0.06MG/24HR
3-134( of 362)
N022416 001 Nov 08, 2013
N022416 002 Nov 08, 2013
N022416 003 Nov 08, 2013
N022416 004 Nov 08, 2013
N019386 006 Feb 25, 2003
A076323 001 Aug 10, 2004
A076573 001 May 02, 2005
A076474 001 May 02, 2005
N019386 005 Jan 27, 2003
N019386 004 Feb 16, 2001
N021153 001 Feb 20, 2001
N021153 002 Feb 20, 2001
N021957 003 Dec 15, 2011
N021957 004 Dec 15, 2011
N022101 001 Feb 27, 2008
N021957 001 Oct 20, 2006
N021957 002 Oct 20, 2006
A202461 001 Sep 27, 2013
A202461 002 Sep 27, 2013
N022511 002 Apr 30, 2010
N022511 001 Apr 30, 2010
A200882 001 Mar 18, 2013
A200882 002 Mar 18, 2013
N021689 001 Mar 31, 2005
N021689 002 Mar 31, 2005
N202342 001 Aug 06, 2013
N202342 002 Aug 06, 2013
A074826 001 Jul 03, 1997
A074826 002 Jul 03, 1997
A074921 001 Jul 10, 1997
A074921 002 Jul 10, 1997
A074818 001 Aug 19, 1997
A074818 002 Aug 19, 1997
A086069 001 Jan 31, 1984
N020375 005 May 27, 2003
N020375 006 May 27, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-135( of 362)
ESTRADIOL
FILM, EXTENDED RELEASE;TRANSDERMAL
ESTRADIOL
AB MYLAN TECHNOLOGIES 0.0375MG/24HR A075182 004 Jul 20, 2006
AB 0.06MG/24HR A075182 005 Jul 20, 2006
VIVELLE
AB1 NOVARTIS 0.05MG/24HR N020323 002 Oct 28, 1994
AB1 0.1MG/24HR N020323 004 Oct 28, 1994
VIVELLE-DOT
AB1 NOVARTIS 0.05MG/24HR N020538 006 Jan 08, 1999
AB1 + 0.1MG/24HR N020538 008 Jan 08, 1999
CLIMARA
AB2 BAYER HLTHCARE 0.025MG/24HR N020375 004 Mar 05, 1999
AB2 0.05MG/24HR N020375 001 Dec 22, 1994
AB2 0.075MG/24HR N020375 003 Mar 23, 1998
AB2 + 0.1MG/24HR N020375 002 Dec 22, 1994
ESTRADIOL
AB2 MYLAN TECHNOLOGIES 0.025MG/24HR A075182 003 Jan 26, 2005
AB2 0.05MG/24HR A075182 006 Feb 24, 2000
AB2 0.075MG/24HR A075182 002 Jan 26, 2005
AB2 0.1MG/24HR A075182 001 Feb 24, 2000
ALORA
BX WATSON LABS 0.025MG/24HR N020655 004 Apr 05, 2002
BX 0.05MG/24HR N020655 001 Dec 20, 1996
BX 0.075MG/24HR N020655 002 Dec 20, 1996
BX 0.1MG/24HR N020655 003 Dec 20, 1996
ESTRADERM
BX NOVARTIS 0.05MG/24HR N019081 002 Sep 10, 1986
BX + 0.1MG/24HR N019081 003 Sep 10, 1986
VIVELLE-DOT
BX NOVARTIS 0.025MG/24HR N020538 009 May 03, 2002
BX 0.0375MG/24HR N020538 005 Jan 08, 1999
BX 0.075MG/24HR N020538 007 Jan 08, 1999
MENOSTAR
+ BAYER HLTHCARE 0.014MG/24HR N021674 001 Jun 08, 2004
MINIVELLE
NOVEN 0.0375MG/24HR N203752 001 Oct 29, 2012
0.05MG/24HR N203752 003 Oct 29, 2012
0.075MG/24HR N203752 002 Oct 29, 2012
+ 0.1MG/24HR N203752 004 Oct 29, 2012
GEL;TRANSDERMAL
DIVIGEL
UPSHER SMITH 0.1% (0.25GM/PACKET) N022038 001 Jun 04, 2007
0.1% (0.5GM/PACKET) N022038 002 Jun 04, 2007
+ 0.1% (1GM/PACKET) N022038 003 Jun 04, 2007
GEL, METERED;TRANSDERMAL
ELESTRIN
+ MEDA PHARMS 0.06% (0.87GM/ACTIVATION) N021813 001 Dec 15, 2006
ESTROGEL
+ ASCEND 0.06% (1.25GM/ACTIVATION) N021166 002 Feb 09, 2004
INSERT, EXTENDED RELEASE;VAGINAL
ESTRING
+ PHARMACIA AND UPJOHN 0.0075MG/24HR N020472 001 Apr 26, 1996
SPRAY;TRANSDERMAL
EVAMIST
+ KV PHARM 1.53MG/SPRAY N022014 001 Jul 27, 2007
TABLET;ORAL
ESTRADIOL
AB BARR LABS INC 0.5MG A040197 001 Oct 22, 1997
AB 1MG A040197 002 Oct 22, 1997
AB + 2MG A040197 003 Oct 22, 1997
AB MYLAN 0.5MG A040326 001 Apr 21, 1999
AB 1MG A040326 002 Apr 21, 1999
AB 2MG A040326 003 Apr 21, 1999
AB USL PHARMA 0.5MG A040297 001 Apr 17, 2002
AB 1MG A040297 002 Apr 17, 2002
AB 2MG A040297 003 Apr 17, 2002
AB WATSON LABS 0.5MG A040114 003 Mar 14, 1996
AB 1MG A040114 001 Mar 14, 1996
AB 2MG A040114 002 Mar 14, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
ESTRADIOL
TABLET;VAGINAL
VAGIFEM
+ NOVO NORDISK INC 10MCG
ESTRADIOL ACETATE
INSERT, EXTENDED RELEASE;VAGINAL
FEMRING
WARNER IRELAND
+
TABLET;ORAL
FEMTRACE
WARNER CHILCOTT LLC
+
ESTRADIOL CYPIONATE
INJECTABLE;INJECTION
DEPO-ESTRADIOL
AO + PHARMACIA AND UPJOHN
ESTRADIOL CYPIONATE
AO WATSON LABS
ESTRADIOL HEMIHYDRATE
EMULSION;TOPICAL
ESTRASORB
+ MEDICIS
ESTRADIOL VALERATE
INJECTABLE;INJECTION
DELESTROGEN
AO + JHP PHARMS
AO +
AO +
ESTRADIOL VALERATE
AO LUITPOLD
AO
AO SANDOZ
AO
AO
ESTRADIOL; LEVONORGESTREL
EQ 0.05MG BASE/24HR
EQ 0.1MG BASE/24HR
0.45MG
0.9MG
1.8MG
5MG/ML
5MG/ML
0.25%
10MG/ML
20MG/ML
40MG/ML
20MG/ML
40MG/ML
10MG/ML
20MG/ML
40MG/ML
FILM, EXTENDED RELEASE;TRANSDERMAL
CLIMARA PRO
+ BAYER HLTHCARE 0.045MG/24HR;0.015MG/24HR
ESTRADIOL; NORETHINDRONE ACETATE
FILM, EXTENDED RELEASE;TRANSDERMAL
COMBIPATCH
NOVARTIS
+
TABLET;ORAL
ACTIVELLA
AB NOVO NORDISK INC
AB +
ESTRADIOL AND NORETHINDRONE ACETATE
0.05MG/24HR;0.14MG/24HR
0.05MG/24HR;0.25MG/24HR
0.5MG;0.1MG
1MG;0.5MG
AB BARR
AB BRECKENRIDGE PHARM
AB
AB TEVA PHARMS USA
ESTRADIOL; NORGESTIMATE
TABLET;ORAL
ESTRADIOL AND NORGESTIMATE
AB BARR
PREFEST
AB + TEVA WOMENS
ESTRAMUSTINE PHOSPHATE SODIUM
CAPSULE;ORAL
EMCYT
+ PHARMACIA AND UPJOHN
1MG;0.5MG
0.5MG;0.1MG
1MG;0.5MG
0.5MG;0.1MG
1MG,1MG;1MG,1MG;N/A,0.09MG
1MG,1MG;1MG,1MG;N/A,0.09MG
EQ 140MG PHOSPHATE
3-136( of 362)
N020908 002 Nov 25, 2009
N021367 001 Mar 20, 2003
N021367 002 Mar 20, 2003
N021633 001 Aug 20, 2004
N021633 002 Aug 20, 2004
N021633 003 Aug 20, 2004
A085470 003
A085620 001
N021371 001 Oct 09, 2003
N009402 002
N009402 004
N009402 003
A090920 001 Jan 19, 2010
A090920 002 Jan 19, 2010
A040628 001 Oct 04, 2007
A040628 002 Oct 04, 2007
A040628 003 Oct 04, 2007
N021258 001 Nov 21, 2003
N020870 001 Aug 07, 1998
N020870 002 Aug 07, 1998
N020907 002 Dec 28, 2006
N020907 001 Nov 18, 1998
A079193 001 May 11, 2010
A078324 002 Jun 09, 2011
A078324 001 Apr 17, 2008
A200747 001 Mar 08, 2012
A076812 001 Apr 29, 2005
N021040 001 Oct 22, 1999
N018045 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-137( of 362)
ESTROGENS, CONJUGATED
CREAM;TOPICAL, VAGINAL
PREMARIN
+ WYETH PHARMS INC 0.625MG/GM N020216 001
INJECTABLE;INJECTION
PREMARIN
+ WYETH PHARMS INC 25MG/VIAL N010402 001
TABLET;ORAL
PREMARIN
WYETH PHARMS INC 0.3MG N004782 003
+
0.45MG
0.625MG
N004782 006
N004782 004
Jul 16, 2003
+
+
0.9MG
1.25MG
N004782 005
N004782 001
Jan 26, 1984
ESTROGENS, CONJUGATED SYNTHETIC A
TABLET;ORAL
CENESTIN
TEVA BRANDED PHARM 0.3MG N020992 001 Jun 21, 2002
0.45MG N020992 005 Feb 05, 2004
0.625MG N020992 002 Mar 24, 1999
0.9MG N020992 003 Mar 24, 1999
+ 1.25MG N020992 004 Mar 13, 2000
ESTROGENS, CONJUGATED SYNTHETIC B
TABLET;ORAL
ENJUVIA
TEVA WOMENS 0.3MG N021443 001 Dec 20, 2004
0.45MG N021443 002 Dec 20, 2004
0.625MG N021443 003 May 10, 2004
0.9MG N021443 005 Apr 27, 2007
+ 1.25MG N021443 004 May 10, 2004
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
TABLET;ORAL-28
PREMPHASE 14/14
+ WYETH PHARMS INC 0.625MG,0.625MG;0.625MG,0.625MG;N/A,5MG N020527 002 Nov 17, 1995
PREMPRO
+ WYETH PHARMS INC 0.3MG;1.5MG N020527 005 Jun 04, 2003
+ 0.45MG;1.5MG N020527 004 Mar 12, 2003
+ 0.625MG;0.625MG;2.5MG;2.5MG N020527 001 Nov 17, 1995
+ 0.625MG;0.625MG;5MG;5MG N020527 003 Jan 09, 1998
ESTROGENS, ESTERIFIED
TABLET;ORAL
MENEST
MONARCH PHARMS 0.3MG A084951 001
0.625MG A084948 001
1.25MG A084950 001
+ 2.5MG A084949 001
ESTROPIPATE
TABLET;ORAL
ESTROPIPATE
AB BARR 0.75MG A040135 001 Nov 27, 1996
AB 1.5MG A040135 002 Nov 27, 1996
AB 3MG A040135 003 Nov 27, 1996
AB MYLAN 0.75MG A040359 001 Aug 26, 1999
AB 1.5MG A040359 002 Aug 26, 1999
AB WATSON LABS 0.75MG A081213 001 Sep 23, 1993
AB 1.5MG A081214 001 Sep 23, 1993
AB 3MG A081215 001 Sep 23, 1993
AB 6MG A081216 001 Sep 23, 1993
OGEN .625
AB PHARMACIA AND UPJOHN 0.75MG A083220 001
OGEN 1.25
AB PHARMACIA AND UPJOHN 1.5MG A083220 002
OGEN 2.5
AB + PHARMACIA AND UPJOHN 3MG A083220 003
OGEN 5
AB PHARMACIA AND UPJOHN 6MG A083220 004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-138( of 362)
ESZOPICLONE
TABLET;ORAL
ESZOPICLONE
AB MYLAN PHARMS INC 1MG A091151 001 Mar 26, 2013
AB 2MG A091151 002 Mar 26, 2013
AB 3MG A091151 003 Mar 26, 2013
AB SUN PHARMA GLOBAL 1MG A091103 001 Apr 03, 2013
AB 2MG A091103 002 Apr 03, 2013
AB 3MG A091103 003 Apr 03, 2013
LUNESTA
AB SUNOVION PHARMS INC 1MG N021476 001 Dec 15, 2004
AB 2MG N021476 002 Dec 15, 2004
AB + 3MG N021476 003 Dec 15, 2004
ETHACRYNATE SODIUM
INJECTABLE;INJECTION
EDECRIN
+ ATON EQ 50MG BASE/VIAL N016093 001
ETHACRYNIC ACID
TABLET;ORAL
EDECRIN
+ ATON 25MG N016092 001
ETHAMBUTOL HYDROCHLORIDE
TABLET;ORAL
ETHAMBUTOL HYDROCHLORIDE
AB BARR 400MG A076057 001 Nov 26, 2001
AB LUPIN 100MG A078939 001 Jun 17, 2009
AB 400MG A078939 002 Jun 17, 2009
MYAMBUTOL
AB STI PHARMA LLC 100MG N016320 001
AB + 400MG N016320 003
ETHANOLAMINE OLEATE
INJECTABLE;INJECTION
ETHAMOLIN
+ QOL MEDCL 50MG/ML N019357 001 Dec 22, 1988
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
TABLET;ORAL-28
KELNOR
AB BARR 0.035MG;1MG A076785 001 May 23, 2005
ZOVIA 1/35E-28
AB WATSON LABS 0.035MG;1MG A072721 001 Dec 30, 1991
ZOVIA 1/50E-28
+ WATSON LABS 0.05MG;1MG A072723 001 Dec 30, 1991
ETHINYL ESTRADIOL; ETONOGESTREL
RING;VAGINAL
NUVARING
+ ORGANON USA INC 0.015MG;0.12MG N021187 001 Oct 03, 2001
ETHINYL ESTRADIOL; LEVONORGESTREL
TABLET;ORAL
DAYSEE
AB LUPIN LTD 0.03MG,0.01MG;0.15MG,N/A A091467 001 Apr 10, 2013
INTROVALE
AB SANDOZ 0.03MG;0.15MG A079064 001 Sep 27, 2010
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB LUPIN LTD 0.02MG,0.01MG;0.1MG,N/A A091674 001 Oct 26, 2011
AB 0.03MG;0.15MG A091440 001 Oct 23, 2012
AB WATSON LABS 0.02MG,0.01MG;0.1MG,N/A A200407 001 Oct 25, 2011
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
AB
AB
AB
WATSON LABS
LOSEASONIQUE
TEVA BRANDED PHARM
QUASENSE
WATSON LABS
SEASONALE
0.03MG,0.01MG;0.15MG,N/A
0.01MG;0.02MG;0.1MG
0.03MG;0.15MG
A078834 001 May 31, 2011
N022262 001 Oct 24, 2008
A077101 001 Sep 06, 2006
AB
AB
+ TEVA BRANDED PHARM 0.03MG;0.15MG
SEASONIQUE
+ TEVA BRANDED PHARM 0.03MG,0.01MG;0.03MG,0.01MG;0.15MG,N/A
LEVONORGESTREL AND ETHINYL ESTRADIOL
N021544 001 Sep 05, 2003
N021840 001 May 25, 2006
+ WATSON LABS 0.02MG;0.09MG A079218 001 Jun 06, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-139( of 362)
ETHINYL ESTRADIOL; LEVONORGESTREL
TABLET;ORAL
QUARTETTE
+ TEVA BRANDED PHARM 0.02MG;0.15MG N204061 001 Mar 28, 2013
TABLET;ORAL-28
ALTAVERA
AB SANDOZ 0.03MG;0.15MG A079102 001 Aug 03, 2010
ENPRESSE-28
AB DURAMED PHARMS BARR 0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1 A075809 002 Jul 16, 2001
25MG
KURVELO
AB LUPIN LTD 0.03MG;0.15MG A091408 001 Oct 17, 2012
LEVONEST
AB NOVAST LABS LTD 0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1 A090719 001 Dec 29, 2010
25MG
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB FAMY CARE LTD 0.03MG;0.15MG A091663 001 Dec 21, 2012
LEVORA 0.15/30-28
AB WATSON LABS 0.03MG;0.15MG A073594 001 Dec 13, 1993
MARLISSA
AB GLENMARK GENERICS 0.03MG;0.15MG A091452 001 Feb 29, 2012
MYZILRA
AB VINTAGE PHARMS LLC 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A077502 001 Nov 23, 2011
25MG
NORDETTE-28
AB + TEVA BRANDED PHARM 0.03MG;0.15MG N018782 001 Jul 21, 1982
PORTIA-28
AB BARR 0.03MG;0.15MG A075866 002 May 23, 2002
TRIVORA-28
AB + WATSON LABS 0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1 A074538 002 Dec 18, 1997
25MG
AVIANE-28
AB1 DURAMED PHARMS BARR 0.02MG;0.1MG A075796 001 Apr 30, 2001
FALMINA
AB1 NOVAST LABS LTD 0.02MG;0.1MG A090721 001 Mar 28, 2012
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB1 FAMY CARE LTD 0.02MG;0.1MG A200245 001 Oct 09, 2013
AB1 LUPIN LTD 0.02MG;0.1MG A091425 001 Jan 18, 2013
AB1 + WATSON LABS 0.02MG;0.1MG A076625 001 Nov 18, 2004
ORSYTHIA
AB1 VINTAGE PHARMS LLC 0.02MG;0.1MG A077099 001 May 11, 2011
LESSINA-28
AB2 BARR 0.02MG;0.1MG A075803 002 Mar 20, 2002
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB2 + WATSON LABS 0.02MG;0.1MG A077681 001 May 31, 2006
ETHINYL ESTRADIOL; NORELGESTROMIN
FILM, EXTENDED RELEASE;TRANSDERMAL
ORTHO EVRA
+ JANSSEN PHARMS 0.75MG;6MG N021180 001 Nov 20, 2001
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET;ORAL-21
NORETHIN 1/35E-21
AB WATSON LABS 0.035MG;1MG A071480 001 Apr 12, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL
AB WATSON LABS 0.035MG;1MG A070685 001 Jan 29, 1987
NORINYL 1+35 21-DAY
AB WATSON LABS 0.035MG;1MG N017565 001
NORTREL 1/35-21
AB BARR 0.035MG;1MG A072693 001 Feb 28, 1992
NORETHINDRONE AND ETHINYL ESTRADIOL
WATSON LABS 0.035MG;0.4MG A078379 001 Feb 23, 2010
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
WATSON LABS 0.035MG;0.035MG;0.5MG;1MG A071043 001 Apr 01, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
WATSON LABS 0.035MG;0.035MG;0.5MG;1MG A071041 001 Sep 24, 1991
NORTREL 7/7/7
BARR 0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M A075478 001 Aug 30, 2002
G
TABLET;ORAL-28
ALYACEN 1/35
AB GLENMARK GENERICS 0.035MG;1MG A091634 001 Jan 19, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-140( of 362)
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET;ORAL-28
ALYACEN 7/7/7
AB GLENMARK GENERICS 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A091636 001 Jan 19, 2012
G
ARANELLE
AB BARR 0.035MG;0.035MG;0.035MG;0.5MG;0.5MG;1MG A076783 001 Sep 29, 2004
BALZIVA-28
AB BARR 0.035MG;0.4MG A076238 001 Apr 22, 2004
BREVICON 28-DAY
AB WATSON LABS 0.035MG;0.5MG N017743 001
BRIELLYN
AB GLENMARK GENERICS 0.035MG;0.4MG A090538 001 Mar 22, 2011
CYCLAFEM 1/35
AB VINTAGE PHARMS LLC 0.035MG;1MG A076337 001 Nov 12, 2010
CYCLAFEM 7/7/7
AB VINTAGE PHARMS LLC 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A076338 001 Nov 16, 2010
G
DASETTA 1/35
AB NOVAST LABS LTD 0.035MG;1MG A090948 001 Dec 22, 2011
DASETTA 7/7/7
AB NOVAST LABS LTD 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A090946 001 Dec 22, 2011
G
GILDAGIA
AB VINTAGE PHARMS 0.035MG;0.4MG A078376 001 Nov 06, 2012
MODICON 28
AB + JANSSEN PHARMS 0.035MG;0.5MG N017735 001
NORETHIN 1/35E-28
AB WATSON LABS 0.035MG;1MG A071481 001 Apr 12, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL
AB + FAMY CARE LTD 0.05MG;1MG A203006 001 Aug 05, 2013
AB WATSON LABS 0.035MG;0.4MG A078323 001 Feb 04, 2010
AB 0.035MG;0.5MG A070686 001 Jan 29, 1987
AB 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A076393 001 Feb 04, 2010
G
AB 0.035MG;1MG A070687 001 Jan 29, 1987
NORINYL 1+35 28-DAY
AB WATSON LABS 0.035MG;1MG N017565 002
NORTREL 0.5/35-28
AB BARR 0.035MG;0.5MG A072695 001 Feb 28, 1992
NORTREL 1/35-28
AB BARR 0.035MG;1MG A072696 001 Feb 28, 1992
NORTREL 7/7/7
AB BARR 0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M A075478 002 Aug 30, 2002
G
ORTHO-NOVUM 1/35-28
AB + JANSSEN PHARMS 0.035MG;1MG N017919 002
ORTHO-NOVUM 7/7/7-28
AB + JANSSEN PHARMS 0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M N018985 002 Apr 04, 1984
G
OVCON-35
AB + WARNER CHILCOTT LLC 0.035MG;0.4MG N017716 001
PHILITH
AB NOVAST LABS LTD 0.035MG;0.4MG A090947 001 Dec 22, 2011
PIRMELLA 1/35
AB LUPIN LTD 0.035MG;1MG A201512 001 Apr 24, 2013
PIRMELLA 7/7/7
AB LUPIN LTD 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A201510 001 Apr 24, 2013
G
TRI-NORINYL 28-DAY
AB + WATSON LABS 0.035MG;0.035MG;0.035MG;0.5MG;0.5MG;1MG N018977 002 Apr 13, 1984
VYFEMLA
AB LUPIN LTD 0.035MG;0.4MG A201886 001 Sep 26, 2013
WERA
AB NOVAST LABS LTD 0.035MG;0.5MG A091204 001 Mar 27, 2012
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
WATSON LABS 0.035MG;0.035MG;0.5MG;1MG A071044 001 Apr 01, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
WATSON LABS 0.035MG,0.035MG;0.035MG,0.035MG;0.5MG,1 A071042 001 Sep 24, 1991
MG;0.5MG,1MG
TABLET, CHEWABLE;ORAL
FEMCON FE
AB + WARNER CHILCOTT LLC 0.035MG;0.4MG N021490 001 Nov 14, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-141( of 362)
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET, CHEWABLE;ORAL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
AB AMNEAL PHARMS 0.035MG;0.4MG A078892 001 Sep 26, 2011
AB BARR 0.035MG;0.4MG A078965 001 Aug 05, 2010
+ WARNER CHILCOTT 0.025MG;0.8MG N022573 001 Dec 22, 2010
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
TABLET;ORAL
LOESTRIN 24 FE
AB + WARNER CHILCOTT 0.02MG;1MG N021871 001 Feb 17, 2006
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
AB AMNEAL PHARMS 0.02MG;1MG A078267 001 Sep 01, 2009
FEMHRT
WARNER CHILCOTT LLC 0.0025MG;0.5MG N021065 001 Jan 14, 2005
LO LOESTRIN FE
+ WARNER CHILCOTT LLC 0.01MG,0.01MG;1MG,N/A N022501 001 Oct 21, 2010
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
+ BARR LABS INC 0.005MG;1MG A076221 001 Nov 06, 2009
TABLET;ORAL-21
JUNEL 1.5/30
AB BARR 0.03MG;1.5MG A076381 001 May 30, 2003
JUNEL 1/20
AB BARR 0.02MG;1MG A076380 001 May 30, 2003
LARIN 1/20
AB NOVAST LABS LTD 0.02MG;1MG A202995 001 Dec 04, 2013
LOESTRIN 21 1.5/30
AB WARNER CHILCOTT LLC 0.03MG;1.5MG N017875 001
LOESTRIN 21 1/20
AB WARNER CHILCOTT LLC 0.02MG;1MG N017876 001
MICROGESTIN 1.5/30
AB WATSON LABS 0.03MG;1.5MG A075548 002 Jul 30, 2003
MICROGESTIN 1/20
AB WATSON LABS 0.02MG;1MG A075647 002 Jul 30, 2003
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
AB FAMY CARE LTD 0.02MG;1MG A202771 001 Nov 06, 2013
TRI-LEGEST 21
BARR 0.02MG;0.035MG;0.03MG;1MG;1MG;1MG A076405 001 Oct 26, 2007
TABLET;ORAL-28
ESTROSTEP FE
AB + WARNER CHILCOTT LLC 0.02MG;0.035MG;0.03MG;1MG;1MG;1MG N020130 002 Oct 09, 1996
GILDESS FE 1.5/30
AB VINTAGE PHARMS LLC 0.03MG;1.5MG A077075 001 Apr 28, 2005
GILDESS FE 1/20
AB VINTAGE PHARMS LLC 0.02MG;1MG A077077 001 May 20, 2005
JUNEL FE 1.5/30
AB BARR 0.03MG;1.5MG A076064 001 Sep 18, 2003
JUNEL FE 1/20
AB BARR 0.02MG;1MG A076081 001 Sep 18, 2003
LARIN FE 1.5/30
AB NOVAST LABS LTD 0.03MG;1.5MG A091453 001 Aug 23, 2013
LARIN FE 1/20
AB NOVAST LABS LTD 0.02MG;1MG A091454 001 Aug 26, 2013
LOESTRIN FE 1.5/30
AB + WARNER CHILCOTT LLC 0.03MG;1.5MG N017355 001
LOESTRIN FE 1/20
AB WARNER CHILCOTT 0.02MG;1MG N017354 001
MICROGESTIN FE 1.5/30
AB WATSON LABS 0.03MG;1.5MG A075548 001 Feb 05, 2001
MICROGESTIN FE 1/20
AB WATSON LABS 0.02MG;1MG A075647 001 Feb 05, 2001
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
AB FAMY CARE LTD 0.02MG;1MG A202772 001 Nov 14, 2013
AB WATSON LABS 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG A076629 001 Mar 18, 2010
TRI-LEGEST FE
AB BARR 0.02MG;0.035MG;0.03MG;1MG;1MG;1MG A076105 001 Oct 26, 2007
TABLET, CHEWABLE;ORAL
MINASTRIN 24 FE
+ WARNER CHILCOTT LLC 0.02MG;1MG N203667 001 May 08, 2013
TABLET, CHEWABLE, TABLET;ORAL
LO MINASTRIN FE
+ WARNER CHILCOTT 0.01MG,0.01MG,N/A;1MG,N/A,N/A N204654 001 Jul 24, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-142( of 362)
ETHINYL ESTRADIOL; NORGESTIMATE
TABLET;ORAL
NORGESTIMATE AND ETHINYL ESTRADIOL
AB GLENMARK GENERICS 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A200494 001 Jun 17, 2011
0.25MG
TABLET;ORAL-28
ESTARYLLA
AB SANDOZ 0.035MG;0.25MG A090794 001 Jan 30, 2013
MONO-LINYAH
AB NOVAST LABS LTD 0.035MG;0.25MG A090523 001 May 23, 2012
NORGESTIMATE AND ETHINYL ESTRADIOL
AB GLENMARK GENERICS 0.035MG;0.25MG A200538 001 Apr 05, 2012
AB LUPIN PHARMS 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, A200541 001 Jun 25, 2012
0.25MG
AB WATSON LABS 0.025MG;0.025MG;0.025MG;0.18MG;0.215MG; A090479 001 Mar 09, 2011
0.25MG
AB 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG; A076626 001 Aug 17, 2006
0.25MG
AB 0.035MG;0.25MG A076627 001 Aug 17, 2006
ORTHO CYCLEN-28
AB + JANSSEN PHARMS 0.035MG;0.25MG N019653 002 Dec 29, 1989
ORTHO TRI-CYCLEN
AB + JANSSEN PHARMS 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG; N019697 001 Jul 03, 1992
0.25MG
ORTHO TRI-CYCLEN LO
AB + JANSSEN PHARMS 0.025MG;0.025MG;0.025MG;0.18MG;0.215MG; N021241 001 Aug 22, 2002
0.25MG
PREVIFEM
AB VINTAGE PHARMS LLC 0.035MG;0.25MG A076334 001 Jan 09, 2004
SPRINTEC
AB BARR 0.035MG;0.25MG A075804 001 Sep 25, 2002
TRI-ESTARYLLA
AB SANDOZ 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A090793 001 Jan 30, 2013
0.25MG
TRI-LINYAH
AB NOVAST LABS LTD 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A090524 001 May 30, 2012
0.25MG
TRI-PREVIFEM
AB VINTAGE PHARMS LLC 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG; A076335 001 Mar 26, 2004
0.25MG
TRI-SPRINTEC
AB BARR 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG; A075808 001 Dec 29, 2003
0.25MG
ETHINYL ESTRADIOL; NORGESTREL
TABLET;ORAL-21
CRYSELLE
AB DURAMED PHARMS BARR 0.03MG;0.3MG A075840 001 Nov 30, 2001
LOW-OGESTREL-21
AB + WATSON LABS 0.03MG;0.3MG A075288 001 Jul 28, 1999
TABLET;ORAL-28
CRYSELLE
AB DURAMED PHARMS BARR 0.03MG;0.3MG A075840 002 Nov 30, 2001
ELINEST
AB NOVAST LABS LTD 0.03MG;0.3MG A091105 001 Mar 28, 2012
LO/OVRAL-28
AB WYETH PHARMS 0.03MG;0.3MG N017802 001
LOW-OGESTREL-28
AB WATSON LABS 0.03MG;0.3MG A075288 002 Jul 28, 1999
OGESTREL 0.5/50-28
+ WATSON LABS 0.05MG;0.5MG A075406 002 Dec 15, 1999
ETHIONAMIDE
TABLET;ORAL
TRECATOR
+ WYETH PHARMS INC 250MG N013026 002
ETHOSUXIMIDE
CAPSULE;ORAL
ETHOSUXIMIDE
AB BANNER PHARMACAPS 250MG A040430 001 Oct 28, 2002
AB VERSAPHARM 250MG A040686 001 May 28, 2008
AB ZYDUS PHARMS USA INC 250MG A200892 001 Sep 25, 2012
ZARONTIN
AB + PARKE DAVIS 250MG N012380 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-143( of 362)
ETHOSUXIMIDE
SYRUP;ORAL
ETHOSUXIMIDE
AA MIKART 250MG/5ML A040506 001 Dec 22, 2003
AA PHARM ASSOC 250MG/5ML A040253 001 Nov 22, 2000
AA TEVA PHARMS 250MG/5ML A081306 001 Jul 30, 1993
ZARONTIN
AA + PARKE DAVIS 250MG/5ML A080258 001
ETHOTOIN
TABLET;ORAL
PEGANONE
+ RECORDATI RARE 250MG N010841 001
ETIDRONATE DISODIUM
TABLET;ORAL
DIDRONEL
AB PROCTER AND GAMBLE 200MG N017831 001
AB + 400MG N017831 002
ETIDRONATE DISODIUM
AB MYLAN 200MG A075800 001 Jan 24, 2003
AB 400MG A075800 002 Jan 24, 2003
ETODOLAC
CAPSULE;ORAL
ETODOLAC
AB APOTEX 200MG A075419 001 Jul 28, 2000
AB 300MG A075419 002 Jul 28, 2000
AB TARO 200MG A075078 001 Apr 30, 1998
AB + 300MG A075078 002 Apr 30, 1998
AB TEVA 300MG A075126 002 Sep 16, 1999
TABLET;ORAL
ETODOLAC
AB APOTEX INC 400MG A076004 001 Dec 03, 2002
AB 500MG A076004 002 Dec 03, 2002
AB MYLAN 400MG A075104 001 Feb 06, 1998
AB 500MG A075104 002 Nov 20, 1998
AB SANDOZ 400MG A074903 001 Apr 11, 1997
AB 500MG A074903 002 Apr 19, 1999
AB TARO PHARM INDS 400MG A075074 001 Mar 11, 1998
AB + 500MG A075074 002 Apr 25, 2000
AB TEVA 400MG A075009 001 Nov 26, 1997
AB 500MG A075009 002 Dec 28, 1999
TABLET, EXTENDED RELEASE;ORAL
ETODOLAC
AB TARO 400MG A076174 001 Mar 13, 2003
AB 500MG A076174 002 Mar 13, 2003
AB 600MG A076174 003 Mar 13, 2003
AB TEVA 400MG A075665 003 Feb 05, 2001
AB 500MG A075665 002 Jul 31, 2000
AB + 600MG A075665 001 Jul 31, 2000
ETOMIDATE
INJECTABLE;INJECTION
AMIDATE
AP + HOSPIRA 2MG/ML N018227 001 Sep 07, 1982
ETOMIDATE
AP BEDFORD 2MG/ML A074593 001 Nov 04, 1996
AP JHP PHARMS LLC 2MG/ML A091297 001 Jun 20, 2012
AP LUITPOLD 2MG/ML A078867 001 Dec 22, 2009
AP STRIDES ARCOLAB LTD 2MG/ML A078289 001 Jan 02, 2009
ETONOGESTREL
IMPLANT;IMPLANTATION
IMPLANON
+ ORGANON USA INC 68MG/IMPLANT N021529 001 Jul 17, 2006
NEXPLANON
+ ORGANON USA INC 68MG/IMPLANT N021529 002 May 31, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-144( of 362)
ETOPOSIDE
CAPSULE;ORAL
ETOPOSIDE
+ MYLAN 50MG A075635 001 Sep 19, 2001
INJECTABLE;INJECTION
ETOPOSIDE
AP ACCORD HLTHCARE 20MG/ML A074513 001 Mar 14, 1996
AP BEDFORD 20MG/ML A074290 001 Jul 17, 1995
AP + FRESENIUS KABI USA 20MG/ML A074983 001 Sep 30, 1998
AP TEVA PHARMS USA 20MG/ML A074284 001 Feb 10, 1994
AP 20MG/ML A074529 001 Jul 24, 1996
ETOPOSIDE PHOSPHATE
INJECTABLE;INJECTION
ETOPOPHOS PRESERVATIVE FREE
+ BRISTOL MYERS SQUIBB EQ 100MG BASE/VIAL N020457 001 May 17, 1996
ETRAVIRINE
TABLET;ORAL
INTELENCE
JANSSEN R AND D 25MG N022187 003 Mar 26, 2012
100MG N022187 001 Jan 18, 2008
+ 200MG N022187 002 Dec 22, 2010
EVEROLIMUS
TABLET;ORAL
AFINITOR
NOVARTIS 2.5MG N022334 003 Jul 09, 2010
5MG N022334 001 Mar 30, 2009
7.5MG N022334 004 Mar 30, 2012
+ 10MG N022334 002 Mar 30, 2009
ZORTRESS
NOVARTIS 0.25MG N021560 001 Apr 20, 2010
0.5MG N021560 002 Apr 20, 2010
+ 0.75MG N021560 003 Apr 20, 2010
TABLET, FOR SUSPENSION;ORAL
AFINITOR DISPERZ
NOVARTIS PHARM 2MG N203985 001 Aug 29, 2012
3MG N203985 002 Aug 29, 2012
+ 5MG N203985 003 Aug 29, 2012
EXEMESTANE
TABLET;ORAL
AROMASIN
AB + PHARMACIA AND UPJOHN 25MG N020753 001 Oct 21, 1999
EXEMESTANE
AB ROXANE 25MG A077431 001 Apr 01, 2011
EXENATIDE SYNTHETIC
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
BYDUREON
+ AMYLIN 2MG/VIAL N022200 001 Jan 27, 2012
INJECTABLE;SUBCUTANEOUS
BYETTA
+ AMYLIN 300MCG/1.2ML (250MCG/ML) N021773 001 Apr 28, 2005
+ 600MCG/2.4ML (250MCG/ML) N021773 002 Apr 28, 2005
EZETIMIBE
TABLET;ORAL
ZETIA
+ MSD INTL GMBH 10MG N021445 001 Oct 25, 2002
EZETIMIBE; SIMVASTATIN
TABLET;ORAL
VYTORIN
MSD INTL 10MG;10MG N021687 001 Jul 23, 2004
10MG;20MG N021687 002 Jul 23, 2004
10MG;40MG N021687 003 Jul 23, 2004
+ 10MG;80MG N021687 004 Jul 23, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-145( of 362)
EZOGABINE
TABLET;ORAL
POTIGA
GLAXOSMITHKLINE 50MG N022345 001 Jun 10, 2011
200MG N022345 002 Jun 10, 2011
300MG N022345 003 Jun 10, 2011
+ 400MG N022345 004 Jun 10, 2011
FAMCICLOVIR
TABLET;ORAL
FAMCICLOVIR
AB APOTEX 125MG A091480 001 Jul 22, 2011
AB 250MG A091480 002 Jul 22, 2011
AB 500MG A091480 003 Jul 22, 2011
AB AUROBINDO PHARMA LTD 125MG A091114 001 Mar 21, 2011
AB 250MG A091114 002 Mar 21, 2011
AB 500MG A091114 003 Mar 21, 2011
AB CIPLA LTD 125MG A078278 001 Mar 21, 2011
AB 250MG A078278 002 Mar 21, 2011
AB 500MG A078278 003 Mar 21, 2011
AB MACLEODS PHARMS LTD 125MG A201022 001 Jan 12, 2012
AB 250MG A201022 002 Jan 12, 2012
AB 500MG A201022 003 Jan 12, 2012
AB MYLAN 125MG A201333 001 Mar 24, 2011
AB 250MG A201333 002 Mar 24, 2011
AB 500MG A201333 003 Mar 24, 2011
AB ROXANE 125MG A090128 001 Mar 21, 2011
AB 250MG A090128 002 Mar 21, 2011
AB 500MG A090128 003 Mar 21, 2011
AB TEVA PHARMS 125MG A077487 001 Aug 24, 2007
AB 250MG A077487 002 Aug 24, 2007
AB 500MG A077487 003 Aug 24, 2007
FAMVIR
AB NOVARTIS 125MG N020363 003 Dec 11, 1995
AB 250MG N020363 001 Apr 26, 1996
AB + 500MG N020363 002 Jun 29, 1994
FAMOTIDINE
FOR SUSPENSION;ORAL
FAMOTIDINE
AB LUPIN LTD 40MG/5ML A090440 001 Jun 29, 2010
AB NAVINTA LLC 40MG/5ML A091020 001 May 27, 2010
PEPCID
AB + SALIX PHARMS 40MG/5ML N019527 001 Feb 02, 1987
INJECTABLE;INJECTION
FAMOTIDINE
AP AGILA SPECLTS 10MG/ML A078641 001 Jun 25, 2008
AP BEDFORD 10MG/ML A075651 001 Apr 16, 2001
AP 10MG/ML A075684 001 Apr 16, 2001
AP FRESENIUS KABI USA 10MG/ML A075709 001 Apr 16, 2001
AP + HIKMA MAPLE 10MG/ML A075488 001 Apr 16, 2001
FAMOTIDINE PRESERVATIVE FREE
AP AGILA SPECLTS 10MG/ML A078642 001 Jun 25, 2008
AP BEDFORD 10MG/ML A075622 001 Apr 16, 2001
AP BEN VENUE 10MG/ML A075825 001 Apr 17, 2001
AP FRESENIUS KABI USA 10MG/ML A075813 001 Apr 16, 2001
AP + HIKMA MAPLE 10MG/ML A075486 001 Apr 16, 2001
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 0.4MG/ML A075591 001 May 10, 2001
SUSPENSION;ORAL
FAMOTIDINE
AB NOVEL LABS INC 40MG/5ML A201695 001 Dec 17, 2012
TABLET;ORAL
FAMOTIDINE
AB ALEMBIC PHARMS LTD 20MG A078916 001 May 22, 2009
AB 40MG A078916 002 May 22, 2009
AB APOTEX 20MG A075611 001 Jul 23, 2001
AB 40MG A075611 002 Jul 23, 2001
AB CARLSBAD 20MG A075805 001 Apr 16, 2001
AB 40MG A075805 002 Apr 16, 2001
AB DR REDDYS LABS LTD 20MG A075718 001 Apr 16, 2001
AB 40MG A075718 002 Apr 16, 2001
AB IVAX SUB TEVA PHARMS 20MG A075511 001 Apr 16, 2001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-146( of 362)
FAMOTIDINE
TABLET;ORAL
FAMOTIDINE
AB 40MG A075511 002 Apr 16, 2001
AB MYLAN 20MG A075704 001 Apr 16, 2001
AB 40MG A075704 002 Apr 16, 2001
AB PERRIGO 20MG A077352 002 Jul 27, 2005
AB 40MG A077352 001 Jul 27, 2005
AB TEVA 20MG A075311 001 Apr 16, 2001
AB 40MG A075311 002 Apr 16, 2001
AB WOCKHARDT 20MG A075786 001 Apr 16, 2001
AB 40MG A075786 002 Apr 16, 2001
PEPCID
AB MARATHON PHARMS 20MG N019462 001 Oct 15, 1986
AB + 40MG N019462 002 Oct 15, 1986
FAMOTIDINE; IBUPROFEN
TABLET;ORAL
DUEXIS
+ HORIZON PHARMA 26.6MG;800MG N022519 001 Apr 23, 2011
FEBUXOSTAT
TABLET;ORAL
ULORIC
TAKEDA PHARMS USA 40MG N021856 001 Feb 13, 2009
+ 80MG N021856 002 Feb 13, 2009
FELBAMATE
SUSPENSION;ORAL
FELBAMATE
AB AMNEAL PHARMS 600MG/5ML A202385 001 Dec 16, 2011
FELBATOL
AB + MEDA PHARMS 600MG/5ML N020189 003 Jul 29, 1993
TABLET;ORAL
FELBAMATE
AB AMNEAL PHARMS 400MG A201680 001 Sep 13, 2011
AB 600MG A201680 002 Sep 13, 2011
FELBATOL
AB MEDA PHARMS 400MG N020189 001 Jul 29, 1993
AB + 600MG N020189 002 Jul 29, 1993
FELODIPINE
TABLET, EXTENDED RELEASE;ORAL
FELODIPINE
AB AUROBINDO PHARMA LTD 2.5MG A203417 001 Jan 17, 2013
AB 5MG A203417 002 Jan 17, 2013
AB 10MG A203417 003 Jan 17, 2013
AB GLENMARK GENERICS 2.5MG A090365 001 Dec 17, 2010
AB 5MG A090365 002 Dec 17, 2010
AB 10MG A090365 003 Dec 17, 2010
AB HERITAGE PHARMS INC 2.5MG A201964 001 Nov 08, 2013
AB 5MG A201964 002 Nov 08, 2013
AB 10MG A201964 003 Nov 08, 2013
AB MUTUAL PHARM 2.5MG A075896 001 Nov 02, 2004
AB 5MG A075896 002 Nov 02, 2004
AB 10MG A075896 003 Nov 02, 2004
AB MYLAN 2.5MG A078855 001 Apr 17, 2008
AB 5MG A078855 002 Apr 17, 2008
AB + 10MG A078855 003 Apr 17, 2008
AB RANBAXY LABS LTD 2.5MG A091200 001 Dec 13, 2013
AB 5MG A091200 002 Dec 13, 2013
AB 10MG A091200 003 Dec 13, 2013
AB TORRENT PHARMS LTD 2.5MG A202170 001 Nov 28, 2011
AB 5MG A202170 002 Nov 28, 2011
AB 10MG A202170 003 Nov 28, 2011
AB VINTAGE PHARMS LLC 2.5MG A200815 001 Oct 28, 2011
AB 5MG A200815 002 Oct 28, 2011
AB 10MG A200815 003 Oct 28, 2011
AB WOCKHARDT LTD 2.5MG A091484 001 Aug 15, 2012
AB 5MG A091484 002 Aug 15, 2012
AB 10MG A091484 003 Aug 15, 2012
PLENDIL
AB ASTRAZENECA 2.5MG N019834 004 Sep 22, 1994
AB 5MG N019834 001 Jul 25, 1991
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-147( of 362)
FELODIPINE
TABLET, EXTENDED RELEASE;ORAL
PLENDIL
AB 10MG N019834 002 Jul 25, 1991
FENOFIBRATE
CAPSULE;ORAL
ANTARA (MICRONIZED)
AB LUPIN ATLANTIS 43MG N021695 001 Nov 30, 2004
AB + 130MG N021695 003 Nov 30, 2004
FENOFIBRATE (MICRONIZED)
AB APOTEX INC 43MG A202252 001 Jul 26, 2013
AB 130MG A202252 002 Jul 26, 2013
AB DR REDDYS LABS SA 43MG A090859 001 Mar 01, 2012
AB 130MG A090859 002 Mar 01, 2012
AB IMPAX LABS 67MG A075868 001 Oct 27, 2003
AB 134MG A075868 002 Oct 27, 2003
AB 200MG A075868 003 Oct 27, 2003
AB MYLAN PHARMS INC 43MG A202579 001 Jan 10, 2013
AB 67MG A202676 001 Oct 23, 2012
AB 130MG A202579 002 Jan 10, 2013
AB 134MG A202676 002 Oct 23, 2012
AB 200MG A202676 003 Oct 23, 2012
AB TEVA 67MG A075753 001 Sep 03, 2002
AB 134MG A075753 002 Apr 09, 2002
AB + 200MG A075753 003 Apr 09, 2002
ANTARA (MICRONIZED)
LUPIN ATLANTIS 30MG N021695 004 Oct 18, 2013
90MG N021695 005 Oct 18, 2013
LIPOFEN
CIPHER PHARMS INC 50MG N021612 001 Jan 11, 2006
+ 150MG N021612 003 Jan 11, 2006
TABLET;ORAL
FENOFIBRATE
AB IMPAX LABS 54MG A076509 001 Mar 26, 2008
AB 160MG A076509 002 Mar 26, 2008
AB LUPIN LTD 48MG A090856 001 Dec 23, 2011
AB 145MG A090856 002 Dec 23, 2011
AB MYLAN 54MG A076520 001 Oct 25, 2007
AB 160MG A076520 003 Oct 25, 2007
AB MYLAN PHARMS INC 48MG A202856 001 Dec 07, 2012
AB 145MG A202856 002 Dec 07, 2012
AB RANBAXY 54MG A076635 001 Oct 31, 2005
AB 160MG A076635 003 Oct 31, 2005
AB TEVA 54MG A076433 001 May 13, 2005
AB + 160MG A076433 002 May 13, 2005
AB VALEANT INTL 48MG A090715 001 Apr 05, 2012
AB 145MG A090715 002 Apr 05, 2012
TRICOR
AB ABBVIE 48MG N021656 001 Nov 05, 2004
AB + 145MG N021656 002 Nov 05, 2004
TRIGLIDE
BX + SKYEPHARMA AG 160MG N021350 002 May 07, 2005
FENOFIBRATE
RANBAXY 107MG A076635 002 Oct 31, 2005
FENOGLIDE
SALIX PHARMS INC 40MG N022118 001 Aug 10, 2007
+ 120MG N022118 002 Aug 10, 2007
TRIGLIDE
SKYEPHARMA AG 50MG N021350 001 May 07, 2005
FENOFIBRIC ACID
TABLET;ORAL
FIBRICOR
MUTUAL PHARM CO INC 35MG N022418 001 Aug 14, 2009
+ 105MG N022418 002 Aug 14, 2009
FENOLDOPAM MESYLATE
INJECTABLE;INJECTION
CORLOPAM
AP + HOSPIRA EQ 10MG BASE/ML N019922 001 Sep 23, 1997
FENOLDOPAM MESYLATE
AP BEDFORD LABS EQ 10MG BASE/ML A076582 001 Oct 12, 2004
AP SANDOZ EQ 10MG BASE/ML A077155 001 Feb 15, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
FENOPROFEN CALCIUM
CAPSULE;ORAL
NALFON
+ XSPIRE
TABLET;ORAL
FENOPROFEN CALCIUM
+ MYLAN PHARMS INC
FENTANYL
FILM, EXTENDED RELEASE;TRANSDERMAL
DURAGESIC-100
AB JANSSEN PHARMS
DURAGESIC-12
AB JANSSEN PHARMS
DURAGESIC-25
AB + JANSSEN PHARMS
DURAGESIC-50
AB JANSSEN PHARMS
DURAGESIC-75
AB JANSSEN PHARMS
FENTANYL-100
AB AVEVA
AB LAVIPHARM LABS
AB MALLINCKRODT INC
AB MYLAN TECHNOLOGIES
AB NOVEN
AB PAR PHARM INC
AB WATSON LABS
FENTANYL-12
AB MYLAN TECHNOLOGIES
FENTANYL-25
AB AVEVA
AB LAVIPHARM LABS
AB MALLINCKRODT INC
AB MYLAN TECHNOLOGIES
AB NOVEN
AB PAR PHARM INC
AB WATSON LABS
FENTANYL-50
AB AVEVA
AB LAVIPHARM LABS
AB MALLINCKRODT INC
AB MYLAN TECHNOLOGIES
AB NOVEN
AB PAR PHARM INC
AB WATSON LABS
FENTANYL-75
AB AVEVA
AB LAVIPHARM LABS
AB MALLINCKRODT INC
AB MYLAN TECHNOLOGIES
AB NOVEN
AB PAR PHARM INC
AB WATSON LABS
SPRAY;SUBLINGUAL
SUBSYS
INSYS THERAP
+
FENTANYL CITRATE
INJECTABLE;INJECTION
FENTANYL CITRATE
AP HOSPIRA
EQ 200MG BASE
EQ 400MG BASE
EQ 600MG BASE
FENTANYL CITRATE PRESERVATIVE FREE
AP + HIKMA MAPLE EQ 0.05MG BASE/ML
AP HOSPIRA EQ 0.05MG BASE/ML
100MCG/HR
12.5MCG/HR
25MCG/HR
50MCG/HR
75MCG/HR
100MCG/HR
100MCG/HR
100MCG/HR
100MCG/HR
100MCG/HR
100MCG/HR
100MCG/HR
12.5MCG/HR
25MCG/HR
25MCG/HR
25MCG/HR
25MCG/HR
25MCG/HR
25MCG/HR
25MCG/HR
50MCG/HR
50MCG/HR
50MCG/HR
50MCG/HR
50MCG/HR
50MCG/HR
50MCG/HR
75MCG/HR
75MCG/HR
75MCG/HR
75MCG/HR
75MCG/HR
75MCG/HR
75MCG/HR
0.1MG
0.2MG
0.4MG
0.6MG
0.8MG
1.2MG
1.6MG
EQ 0.05MG BASE/ML
3-148( of 362)
N017604 003
N017604 004 Jul 21, 2009
A072267 001 Aug 17, 1988
N019813 001 Aug 07, 1990
N019813 005 Feb 04, 2005
N019813 004 Aug 07, 1990
N019813 003 Aug 07, 1990
N019813 002 Aug 07, 1990
A077449 004 Oct 20, 2008
A077051 004 Aug 04, 2006
A077154 004 Feb 09, 2011
A076258 004 Jan 28, 2005
A077775 004 Oct 16, 2009
A077062 004 Aug 20, 2007
A076709 004 Aug 20, 2007
A076258 005 Jan 23, 2007
A077449 001 Oct 20, 2008
A077051 001 Aug 04, 2006
A077154 001 Feb 09, 2011
A076258 001 Jan 28, 2005
A077775 001 Oct 16, 2009
A077062 001 Aug 20, 2007
A076709 001 Aug 20, 2007
A077449 002 Oct 20, 2008
A077051 002 Aug 04, 2006
A077154 002 Feb 09, 2011
A076258 002 Jan 28, 2005
A077775 002 Oct 16, 2009
A077062 002 Aug 20, 2007
A076709 002 Aug 20, 2007
A077449 003 Oct 20, 2008
A077051 003 Aug 04, 2006
A077154 003 Feb 09, 2011
A076258 003 Jan 28, 2005
A077775 003 Oct 16, 2009
A077062 003 Aug 20, 2007
A076709 003 Aug 20, 2007
N202788 001 Jan 04, 2012
N202788 002 Jan 04, 2012
N202788 003 Jan 04, 2012
N202788 004 Jan 04, 2012
N202788 005 Jan 04, 2012
N202788 006 Aug 30, 2012
N202788 007 Aug 30, 2012
N019115 001 Jan 12, 1985
N019101 001 Jul 11, 1984
A072786 001 Sep 24, 1991
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
FENTANYL CITRATE
INJECTABLE;INJECTION
SUBLIMAZE PRESERVATIVE FREE
AP + AKORN
SPRAY, METERED;NASAL
LAZANDA
DEPOMED INC
+
TABLET;BUCCAL
FENTANYL CITRATE
AB WATSON LABS
AB
AB
AB
AB
TABLET;BUCCAL, SUBLINGUAL
FENTORA
AB CEPHALON
AB
AB +
AB
AB
TABLET;SUBLINGUAL
ABSTRAL
GALENA BIOPHARMA
+
TROCHE/LOZENGE;TRANSMUCOSAL
ACTIQ
AB CEPHALON
AB +
AB
AB
AB
AB
FENTANYL CITRATE
AB MALLINCKRODT
AB
AB
AB
AB
AB
AB PAR PHARM
AB
AB
AB
AB
AB
FERRIC CARBOXYMALTOSE
INJECTABLE;INTRAVENOUS
INJECTAFER
+ LUITPOLD
FERRIC HEXACYANOFERRATE(II)
CAPSULE;ORAL
EQ 0.05MG BASE/ML
EQ 0.1MG BASE
EQ 0.4MG BASE
EQ 0.1MG BASE
EQ 0.2MG BASE
EQ 0.4MG BASE
EQ 0.6MG BASE
EQ 0.8MG BASE
EQ 0.1MG BASE
EQ 0.2MG BASE
EQ 0.4MG BASE
EQ 0.6MG BASE
EQ 0.8MG BASE
EQ 0.1MG BASE
EQ 0.2MG BASE
EQ 0.3MG BASE
EQ 0.4MG BASE
EQ 0.6MG BASE
EQ 0.8MG BASE
EQ 0.2MG BASE
EQ 0.4MG BASE
EQ 0.6MG BASE
EQ 0.8MG BASE
EQ 1.2MG BASE
EQ 1.6MG BASE
EQ 0.2MG BASE
EQ 0.4MG BASE
EQ 0.6MG BASE
EQ 0.8MG BASE
EQ 1.2MG BASE
EQ 1.6MG BASE
EQ 0.2MG BASE
EQ 0.4MG BASE
EQ 0.6MG BASE
EQ 0.8MG BASE
EQ 1.2MG BASE
EQ 1.6MG BASE
750MG IRON/15ML (50MG IRON/ML)
RADIOGARDASE (PRUSSIAN BLUE)
+ HEYL CHEMISCH 500MG
FERUMOXYTOL
SOLUTION;INTRAVENOUS
FERAHEME
+ AMAG PHARMS INC EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
FESOTERODINE FUMARATE
TABLET, EXTENDED RELEASE;ORAL
TOVIAZ
PFIZER 4MG
+ 8MG
3-149( of 362)
N016619 001
N022569 001 Jun 30, 2011
N022569 002 Jun 30, 2011
A079075 001 Jan 07, 2011
A079075 002 Jan 07, 2011
A079075 003 Jan 07, 2011
A079075 004 Jan 07, 2011
A079075 005 Jan 07, 2011
N021947 001 Sep 25, 2006
N021947 002 Sep 25, 2006
N021947 003 Sep 25, 2006
N021947 004 Sep 25, 2006
N021947 005 Sep 25, 2006
N022510 001 Jan 07, 2011
N022510 002 Jan 07, 2011
N022510 003 Jan 07, 2011
N022510 004 Jan 07, 2011
N022510 005 Jan 07, 2011
N022510 006 Jan 07, 2011
N020747 001 Nov 04, 1998
N020747 002 Nov 04, 1998
N020747 003 Nov 04, 1998
N020747 004 Nov 04, 1998
N020747 005 Nov 04, 1998
N020747 006 Nov 04, 1998
A078907 001 Oct 30, 2009
A078907 002 Oct 30, 2009
A078907 003 Oct 30, 2009
A078907 004 Oct 30, 2009
A078907 005 Oct 30, 2009
A078907 006 Oct 30, 2009
A077312 001 Oct 30, 2009
A077312 002 Oct 30, 2009
A077312 003 Oct 30, 2009
A077312 004 Oct 30, 2009
A077312 005 Oct 30, 2009
A077312 006 Oct 30, 2009
N203565 001 Jul 25, 2013
N021626 001 Oct 02, 2003
N022180 001 Jun 30, 2009
N022030 001 Oct 31, 2008
N022030 002 Oct 31, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
FEXOFENADINE HYDROCHLORIDE
SUSPENSION;ORAL
ALLEGRA
AB + SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE
AB ACTAVIS MID ATLANTIC
TABLET;ORAL
FEXOFENADINE HYDROCHLORIDE
AB BARR
AB
AB
AB DR REDDYS LABS LTD
AB
AB
AB MYLAN
AB
AB
AB TEVA
AB
AB
30MG/5ML
30MG/5ML
30MG
60MG
180MG
30MG
60MG
180MG
30MG
60MG
180MG
30MG
60MG
180MG
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
AB BARR
AB IMPAX PHARMS
FIDAXOMICIN
TABLET;ORAL
DIFICID
+ OPTIMER PHARMS
FINASTERIDE
TABLET;ORAL
FINASTERIDE
AB ACCORD HLTHCARE
AB ACCORD HLTHCARE INC
AB ACTAVIS TOTOWA
AB
AB AUROBINDO PHARMA
AB AUROBINDO PHARMA LTD
AB DR REDDYS LABS INC
AB DR REDDYS LABS LTD
AB GEDEON RICHTER USA
AB HETERO LABS LTD III
AB
AB MYLAN
AB MYLAN PHARMS INC
AB SUN PHARMA GLOBAL
AB
AB TEVA
AB
AB ZYDUS PHARMS USA INC
PROPECIA
AB + MERCK
PROSCAR
AB + MERCK
FINGOLIMOD
CAPSULE;ORAL
GILENYA
+ NOVARTIS
FLAVOXATE HYDROCHLORIDE
TABLET;ORAL
FLAVOXATE HYDROCHLORIDE
AB EPIC PHARMA
AB IMPAX PHARMS
AB + PADDOCK LLC
60MG;120MG
60MG;120MG
200MG
5MG
1MG
1MG
5MG
5MG
1MG
1MG
5MG
5MG
1MG
5MG
5MG
1MG
1MG
5MG
1MG
5MG
5MG
1MG
5MG
0.5MG
100MG
100MG
100MG
3-150( of 362)
N021963 001 Oct 16, 2006
A201311 001 Jul 25, 2012
A076191 001 Aug 31, 2005
A076191 002 Aug 31, 2005
A076191 003 Aug 31, 2005
A076502 001 Apr 11, 2006
A076502 002 Apr 11, 2006
A076502 003 Apr 11, 2006
A077081 002 Apr 11, 2008
A077081 003 Apr 11, 2008
A077081 001 Apr 16, 2007
A076447 001 Sep 01, 2005
A076447 002 Sep 01, 2005
A076447 003 Sep 01, 2005
A076236 001 Apr 14, 2005
A076298 001 Nov 12, 2010
N201699 001 May 27, 2011
A090121 001 Feb 23, 2010
A091643 001 Nov 05, 2013
A078371 001 Nov 05, 2013
A077914 001 Mar 28, 2007
A078341 001 Oct 30, 2007
A203687 001 Nov 05, 2013
A076436 001 Jul 28, 2006
A076437 001 Feb 28, 2007
A077251 001 Dec 22, 2006
A090060 001 Jul 01, 2013
A090061 001 Jun 07, 2010
A077578 001 Dec 18, 2006
A078161 001 Nov 05, 2013
A090508 001 Jul 01, 2013
A090507 001 Aug 16, 2011
A076905 001 Nov 05, 2013
A076511 001 Dec 15, 2006
A078900 001 Dec 28, 2009
N020788 001 Dec 19, 1997
N020180 001 Jun 19, 1992
N022527 001 Sep 21, 2010
A076835 001 Nov 30, 2005
A076234 001 Aug 28, 2003
A076831 001 Dec 16, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-151( of 362)
FLECAINIDE ACETATE
TABLET;ORAL
FLECAINIDE ACETATE
AB AMNEAL PHARM 50MG A075442 001 Jul 31, 2001
AB 100MG A075442 002 Jul 31, 2001
AB 150MG A075442 003 Jul 31, 2001
AB BARR 50MG A075882 001 Oct 28, 2002
AB 100MG A075882 002 Oct 28, 2002
AB 150MG A075882 003 Oct 28, 2002
AB RANBAXY 50MG A076421 001 Mar 28, 2003
AB 100MG A076421 002 Mar 28, 2003
AB 150MG A076421 003 Mar 28, 2003
AB ROXANE 50MG A076278 001 Jan 14, 2003
AB 100MG A076278 002 Jan 14, 2003
AB + 150MG A076278 003 Jan 14, 2003
FLORBETAPIR F-18
SOLUTION;INTRAVENOUS
AMYVID
+ AVID RADIOPHARMS INC 10ML (13.5-51MCI/ML) N202008 001 Apr 06, 2012
+ 10-30ML (13.5-51MCI/ML) N202008 002 Apr 06, 2012
+ 10-50ML (13.5-51MCI/ML) N202008 003 Apr 06, 2012
FLOXURIDINE
INJECTABLE;INJECTION
FLOXURIDINE
AP + BEDFORD 500MG/VIAL A075387 001 Apr 16, 2000
AP FRESENIUS KABI USA 500MG/VIAL A075837 001 Feb 22, 2001
FLUCONAZOLE
FOR SUSPENSION;ORAL
DIFLUCAN
AB PFIZER 50MG/5ML N020090 001 Dec 23, 1993
AB + 200MG/5ML N020090 002 Dec 23, 1993
FLUCONAZOLE
AB AUROBINDO PHARM 50MG/5ML A079150 001 Sep 18, 2009
AB 200MG/5ML A079150 002 Sep 18, 2009
AB IVAX SUB TEVA PHARMS 50MG/5ML A077523 001 Sep 12, 2007
AB 200MG/5ML A077523 002 Sep 12, 2007
AB RANBAXY 50MG/5ML A076332 001 Jul 29, 2004
AB 200MG/5ML A076332 002 Jul 29, 2004
AB ROXANE 50MG/5ML A076246 001 Jul 29, 2004
AB 200MG/5ML A076246 002 Jul 29, 2004
INJECTABLE;INJECTION
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + PFIZER 200MG/100ML (2MG/ML) N019950 003 Sep 29, 1992
AP + 400MG/200ML (2MG/ML) N019950 005 Jul 08, 1994
DIFLUCAN IN SODIUM CHLORIDE 0.9%
AP + PFIZER 200MG/100ML (2MG/ML) N019950 001 Jan 29, 1990
AP + 400MG/200ML (2MG/ML) N019950 006 Jan 29, 1990
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP
AP
+ PFIZER 200MG/100ML (2MG/ML)
+ 400MG/200ML (2MG/ML)
FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
N019950 002 Jan 29, 1990
N019950 004 Jan 29, 1990
AP
AP
ACS DOBFAR INFO SA 200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
A079104 001 Jul 30, 2009
A079104 002 Jul 30, 2009
AP
AP
AP
AP
AP
AP
CLARIS LIFESCIENCES 200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
HIKMA FARMACEUTICA 200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
HOSPIRA 200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
A077988 001 May 26, 2010
A077988 002 May 26, 2010
A078764 001 Jan 30, 2012
A078764 002 Jan 30, 2012
A076304 001 Jul 29, 2004
A076304 002 Jul 29, 2004
AP
AP
AP
AP
AP
AP
AP
AP
AP
BEDFORD
CLARIS LIFESCIENCES
FRESENIUS KABI USA
HIKMA FARMACEUTICA
TEVA PHARMS USA
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
200MG/100ML (2MG/ML)
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
A076087 001 Jul 29, 2004
A076087 003 Jul 29, 2004
A077947 001 May 26, 2010
A077947 002 May 26, 2010
A076145 001 Jul 29, 2004
A076145 002 Jul 29, 2004
A076736 001 Aug 23, 2005
A076653 001 Jul 29, 2004
A076653 002 Jul 29, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
FLUCONAZOLE
INJECTABLE;INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE
AP
AP BEDFORD LABS
AP
AP CLARIS LIFESCIENCES
AP
AP HIKMA FARMACEUTICA
AP
AP HOSPIRA
AP
AP TEVA PHARMS
AP
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
BEDFORD
TABLET;ORAL
DIFLUCAN
AB PFIZER
AB
AB
AB +
FLUCONAZOLE
AB APOTEX
AB
AB
AB
AB AUROBINDO PHARMA
AB
AB
AB
AB GLENMARK GENERICS
AB
AB
AB
AB IVAX SUB TEVA PHARMS
AB
AB
AB
AB MYLAN
AB
AB
AB
AB TARO
AB
AB
AB
AB TEVA
AB
AB
AB
AB
AB
UNIQUE PHARM LABS
AB
BX DR REDDYS LABS INC
BX
BX
BX
FLUCYTOSINE
CAPSULE;ORAL
ANCOBON
AB VALEANT
AB +
FLUCYTOSINE
AB SIGMAPHARM LABS LLC
AB
100MG/50ML (2MG/ML)
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
200MG
50MG
100MG
150MG
200MG
250MG
500MG
250MG
500MG
3-152( of 362)
A076766 001 Jul 29, 2004
A076766 002 Jul 29, 2004
A078107 001 Jul 30, 2008
A078107 002 Jul 30, 2008
A077909 001 May 26, 2010
A077909 002 May 26, 2010
A078698 001 Jan 30, 2012
A078698 002 Jan 30, 2012
A076303 001 Jul 29, 2004
A076303 002 Jul 29, 2004
A076837 001 Jan 13, 2005
A076837 002 Jan 13, 2005
A076087 002 Sep 26, 2008
N019949 001 Jan 29, 1990
N019949 002 Jan 29, 1990
N019949 004 Jun 30, 1994
N019949 003 Jan 29, 1990
A076665 001 Jul 29, 2004
A076665 002 Jul 29, 2004
A076665 003 Jul 29, 2004
A076665 004 Jul 29, 2004
A077731 001 Oct 07, 2008
A077731 002 Oct 07, 2008
A077731 003 Oct 07, 2008
A077731 004 Oct 07, 2008
A077253 001 Jan 25, 2006
A077253 002 Jan 25, 2006
A077253 003 Jan 25, 2006
A077253 004 Jan 25, 2006
A076077 001 Jul 29, 2004
A076077 002 Jul 29, 2004
A076077 003 Jul 29, 2004
A076077 004 Jul 29, 2004
A076351 001 Jul 29, 2004
A076351 002 Jul 29, 2004
A076351 003 Jul 29, 2004
A076351 004 Jul 29, 2004
A076507 001 Jul 29, 2004
A076507 002 Jul 29, 2004
A076507 003 Jul 29, 2004
A076507 004 Jul 29, 2004
A074681 001 Jul 29, 2004
A074681 002 Jul 29, 2004
A074681 003 Jul 29, 2004
A074681 004 Jul 29, 2004
A076957 001 Sep 28, 2005
A076957 002 Sep 28, 2005
A076957 003 Sep 28, 2005
A076658 001 Jul 29, 2004
A076658 002 Jul 29, 2004
A076658 003 Jul 29, 2004
A076658 004 Jul 29, 2004
N017001 001
N017001 002
A201566 001 Jun 28, 2011
A201566 002 Jun 28, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-153( of 362)
FLUDARABINE PHOSPHATE
INJECTABLE;INJECTION
FLUDARABINE PHOSPHATE
AP ACTAVIS TOTOWA 50MG/VIAL A078610 001 Feb 11, 2009
AP + FRESENIUS KABI USA 50MG/2ML (25MG/ML) A078393 001 Oct 15, 2007
AP 50MG/VIAL A078544 001 Oct 15, 2007
AP + HOSPIRA 50MG/VIAL A077790 001 Apr 06, 2007
AP MYLAN INSTITUTIONAL 50MG/2ML (25MG/ML) A090724 001 Sep 27, 2010
AP ONCO THERAPIES LTD 50MG/2ML (25MG/ML) A200647 001 Dec 21, 2011
AP 50MG/VIAL A200648 001 Oct 16, 2012
AP + SANDOZ 50MG/2ML (25MG/ML) N022137 001 Sep 21, 2007
AP TEVA PHARMS USA 50MG/VIAL A076349 001 Aug 28, 2003
AP 50MG/2ML (25MG/ML) A076661 001 Apr 28, 2004
FLUDEOXYGLUCOSE F-18
INJECTABLE;INTRAVENOUS
FLUDEOXYGLUCOSE F-18
AP WI MEDCL CYCLOTRON 20-500mCi/ML A203709 001 Oct 23, 2013
FLUDEOXYGLUCOSE F18
AP + FEINSTEIN 20-200mCi/ML N021870 001 Aug 19, 2005
AP + 20-300mCi/ML N021870 002 Nov 21, 2008
AP + HOUSTON CYCLOTRON 20-500mCi/ML A203665 001 Feb 14, 2013
AP PETNET 20-200mCi/ML A079086 001 Feb 25, 2011
AP UNIV TX MD ANDERSON 20-300mCi/ML A203246 002 Jan 13, 2014
MCPRF 20-240mCi/ML A203612 001 Aug 05, 2013
+ UCLA BIOMEDICAL 4-40mCi/ML A203811 001 Jun 27, 2013
UNIV TX MD ANDERSON 20-150mCi/ML A203246 001 Jan 13, 2014
+ WEILL MEDCL COLL 10-100mCi/ML N021768 001 Aug 05, 2004
FLUDROCORTISONE ACETATE
TABLET;ORAL
FLUDROCORTISONE ACETATE
AB BARR 0.1MG A040425 001 Jan 21, 2003
AB + IMPAX LABS 0.1MG A040431 001 Mar 18, 2002
AB WEST-WARD PHARM CORP 0.1MG A091302 001 Jul 22, 2011
FLUMAZENIL
INJECTABLE;INJECTION
FLUMAZENIL
AP AGILA SPECLTS 0.5MG/5ML (0.1MG/ML) A078595 001 May 13, 2008
AP + 1MG/10ML (0.1MG/ML) A078595 002 May 13, 2008
AP BEDFORD LABS 0.5MG/5ML (0.1MG/ML) A076256 002 Oct 12, 2004
AP 1MG/10ML (0.1MG/ML) A076256 001 Oct 12, 2004
AP FRESENIUS KABI USA 0.5MG/5ML (0.1MG/ML) A076955 002 Oct 12, 2004
AP 1MG/10ML (0.1MG/ML) A076955 001 Oct 12, 2004
AP HIKMA FARMACEUTICA 0.5MG/5ML (0.1MG/ML) A078527 001 Mar 23, 2009
AP 1MG/10ML (0.1MG/ML) A078527 002 Mar 23, 2009
AP HIKMA MAPLE 0.5MG/5ML (0.1MG/ML) A076787 002 Oct 12, 2004
AP 1MG/10ML (0.1MG/ML) A076787 001 Oct 12, 2004
AP SAGENT PHARMS 0.5MG/5ML (0.1MG/ML) A090584 001 Aug 28, 2012
AP 1MG/10ML (0.1MG/ML) A090584 002 Aug 28, 2012
AP SANDOZ 0.5MG/5ML (0.1MG/ML) A077071 001 May 03, 2005
AP 1MG/10ML (0.1MG/ML) A077071 002 May 03, 2005
FLUNISOLIDE
AEROSOL, METERED;INHALATION
AEROSPAN HFA
+ ACTON PHARMS EQ 78MG BASE/INH N021247 001 Jan 27, 2006
SPRAY, METERED;NASAL
FLUNISOLIDE
AB + BAUSCH AND LOMB 0.025MG/SPRAY A074805 001 Feb 20, 2002
AB HI TECH PHARMA CO 0.025MG/SPRAY A077704 001 Aug 03, 2006
+ APOTEX INC 0.029MG/SPRAY A077436 001 Aug 09, 2007
FLUOCINOLONE ACETONIDE
CREAM;TOPICAL
FLUOCINOLONE ACETONIDE
AT FOUGERA 0.01% A088170 001 Dec 16, 1982
AT 0.025% A088169 001 Dec 16, 1982
AT G AND W LABS 0.01% A089526 001 Jul 26, 1988
AT 0.025% A089525 001 Jul 26, 1988
AT TARO 0.025% A087104 001 Apr 27, 1982
SYNALAR
AT + MEDIMETRIKS PHARMS 0.01% N012787 004
AT + 0.025% N012787 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-154( of 362)
FLUOCINOLONE ACETONIDE
CREAM;TOPICAL
SYNALAR
AT + 0.025% N012787 005
IMPLANT;INTRAVITREAL
RETISERT
+ BAUSCH AND LOMB 0.59MG N021737 001 Apr 08, 2005
OIL;TOPICAL
DERMA-SMOOTHE/FS
AT + HILL DERMAC 0.01% N019452 001 Feb 03, 1988
AT + 0.01% N019452 002 Nov 09, 2005
FLUOCINOLONE ACETONIDE
AT IDENTI PHARMS INC 0.01% A201759 001 Oct 17, 2011
AT 0.01% A201764 001 Oct 17, 2011
AT PERRIGO ISRAEL 0.01% A202847 001 Aug 09, 2013
AT 0.01% A202848 001 Aug 09, 2013
OIL/DROPS;OTIC
DERMOTIC
AT + HILL DERMAC 0.01% N019452 003 Nov 09, 2005
FLUOCINOLONE ACETONIDE
AT IDENTI PHARMS INC 0.01% A091306 001 Oct 17, 2011
OINTMENT;TOPICAL
FLUOCINOLONE ACETONIDE
AT FOUGERA 0.025% A088168 001 Dec 16, 1982
AT G AND W LABS 0.025% A089524 001 Jul 26, 1988
AT TARO 0.025% A040041 001 Sep 15, 1994
SYNALAR
AT + MEDIMETRIKS PHARMS 0.025% N013960 001
SHAMPOO;TOPICAL
CAPEX
+ GALDERMA LABS LP 0.01% N020001 001 Aug 27, 1990
SOLUTION;TOPICAL
FLUOCINOLONE ACETONIDE
AT FOUGERA 0.01% A088167 001 Dec 16, 1982
AT TARO 0.01% A089124 001 Sep 11, 1985
SYNALAR
AT + MEDIMETRIKS PHARMS 0.01% N015296 001
FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
CREAM;TOPICAL
TRI-LUMA
+ GALDERMA LABS LP 0.01%;4%;0.05% N021112 001 Jan 18, 2002
FLUOCINONIDE
CREAM;TOPICAL
FLUOCINONIDE
AB PERRIGO ISRAEL 0.1% A090256 001 Jan 14, 2014
VANOS
AB + MEDICIS 0.1% N021758 001 Feb 11, 2005
FLUOCINONIDE
AB1 FOUGERA 0.05% A073030 001 Oct 17, 1994
AB1 G AND W LABS INC 0.05% A073085 001 Feb 14, 1992
AB1 + TARO 0.05% N019117 001 Jun 26, 1984
AB1 TEVA 0.05% A072488 001 Feb 06, 1989
FLUOCINONIDE EMULSIFIED BASE
AB2 FOUGERA PHARMS 0.05% A076586 001 Jun 23, 2004
AB2 + TARO 0.05% A072494 001 Jan 19, 1989
AB2 TEVA 0.05% A072490 001 Feb 07, 1989
GEL;TOPICAL
FLUOCINONIDE
AB FOUGERA 0.05% A072933 001 Dec 30, 1994
AB + TARO 0.05% A074935 001 Jul 29, 1997
AB TEVA 0.05% A072537 001 Feb 07, 1989
OINTMENT;TOPICAL
FLUOCINONIDE
AB FOUGERA PHARMS 0.05% A074905 001 Aug 26, 1997
AB + TARO 0.05% A075008 001 Jun 30, 1999
AB TEVA 0.05% A073481 001 Dec 27, 1991
SOLUTION;TOPICAL
FLUOCINONIDE
AT ACTAVIS MID ATLANTIC 0.05% A071535 001 Dec 02, 1988
AT FOUGERA 0.05% A072934 001 Feb 27, 1995
AT + TARO 0.05% A074799 001 Dec 31, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-155( of 362)
FLUOCINONIDE
SOLUTION;TOPICAL
FLUOCINONIDE
AT TEVA 0.05% A072511 001 Feb 07, 1989
FLUORESCEIN SODIUM
INJECTABLE;INTRAVENOUS
AK-FLUOR 10%
AP AKORN EQ 500MG BASE/5ML (EQ 100MG BASE/ML) N022186 001 Aug 08, 2008
FLUORESCITE
AP + ALCON PHARMS LTD EQ 500MG BASE/5ML (EQ 100MG BASE/ML) N021980 001 Mar 28, 2006
AK-FLUOR 25%
+ AKORN EQ 500MG BASE/2ML (EQ 250MG BASE/ML) N022186 002 Aug 08, 2008
FLUOROMETHOLONE
OINTMENT;OPHTHALMIC
FML
+ ALLERGAN 0.1% N017760 001 Sep 04, 1985
SUSPENSION/DROPS;OPHTHALMIC
FML
+ ALLERGAN 0.1% N016851 002 Jul 28, 1982
FML FORTE
ALLERGAN 0.25% N019216 001 Apr 23, 1986
FLUOROMETHOLONE ACETATE
SUSPENSION/DROPS;OPHTHALMIC
FLAREX
+ ALCON 0.1% N019079 001 Feb 11, 1986
FLUOROURACIL
CREAM;TOPICAL
EFUDEX
AB + VALEANT PHARM INTL 5% N016831 003
FLUOROURACIL
AB SPEAR PHARMS 5% A077524 001 Apr 11, 2008
AB TARO 5% A090368 001 Mar 05, 2010
CARAC
+ VALEANT BERMUDA 0.5% N020985 001 Oct 27, 2000
FLUOROPLEX
+ AQUA PHARMS 1% N016988 001
INJECTABLE;INJECTION
FLUOROURACIL
AP + ACCORD HLTHCARE 1GM/20ML (50MG/ML) A040743 001 Apr 26, 2007
AP + 2.5GM/50ML (50MG/ML) A040798 002 Apr 26, 2007
AP + 5GM/100ML (50MG/ML) A040798 001 Apr 26, 2007
AP + 500MG/10ML (50MG/ML) A040743 002 Apr 26, 2007
AP EBEWE PHARMA 500MG/10ML (50MG/ML) A040772 001 Aug 11, 2008
AP + FRESENIUS KABI USA 1GM/20ML (50MG/ML) A040279 001 Sep 30, 1998
AP + 2.5GM/50ML (50MG/ML) A040278 001 Sep 30, 1998
AP + 5GM/100ML (50MG/ML) A040278 002 Sep 30, 1998
AP + 500MG/10ML (50MG/ML) A040279 002 Sep 30, 1998
AP ONCO THERAPIES LTD 1GM/20ML (50MG/ML) A202668 002 Jul 17, 2012
AP 2.5GM/50ML (50MG/ML) A202669 001 Jul 17, 2012
AP 5GM/100ML (50MG/ML) A202669 002 Jul 17, 2012
AP 500MG/10ML (50MG/ML) A202668 001 Jul 17, 2012
AP SANDOZ 2.5GM/50ML (50MG/ML) A091299 001 May 02, 2011
AP 5GM/100ML (50MG/ML) A091299 002 May 02, 2011
AP + TEVA PHARMS USA 2.5GM/50ML (50MG/ML) A040334 001 Feb 25, 2000
AP + 5GM/100ML (50MG/ML) A040334 002 Feb 25, 2000
AP + 500MG/10ML (50MG/ML) A040333 001 Jan 27, 2000
SOLUTION;TOPICAL
EFUDEX
AT + VALEANT PHARM INTL 2% N016831 001
AT + 5% N016831 002
FLUOROURACIL
AT TARO 2% A076526 001 Nov 05, 2003
AT 5% A076526 002 Nov 05, 2003
FLUOXETINE HYDROCHLORIDE
CAPSULE;ORAL
FLUOXETINE HYDROCHLORIDE
AB ALEMBIC PHARMS LTD EQ 40MG BASE A090223 003 Mar 19, 2009
AB AUROBINDO PHARMA EQ 40MG BASE A078619 003 Jan 31, 2008
AB DR REDDYS LABS LTD EQ 40MG BASE A075465 003 Aug 02, 2001
AB HERITAGE PHARMS INC EQ 40MG BASE A201336 003 Oct 01, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
FLUOXETINE HYDROCHLORIDE
CAPSULE;ORAL
FLUOXETINE HYDROCHLORIDE
AB IVAX SUB TEVA PHARMS
AB MYLAN
AB PAR PHARM
AB RANBAXY
AB SANDOZ
AB TEVA
PROZAC
AB + ELI LILLY AND CO
FLUOXETINE HYDROCHLORIDE
AB1 ALEMBIC PHARMS LTD
AB1
AB1 AUROBINDO PHARMA
AB1
AB1 BARR
AB1
AB1 DR REDDYS LABS LTD
AB1
AB1 HERITAGE PHARMS INC
AB1
AB1 IVAX SUB TEVA PHARMS
AB1
AB1 LANDELA PHARM
AB1
AB1 MALLINCKRODT
AB1
AB1 MYLAN
AB1
AB1 MYLAN PHARMS INC
AB1
AB1 SANDOZ
AB1
AB1 TEVA
AB1
AB1 TEVA PHARMS USA
AB1
PROZAC
AB1 ELI LILLY AND CO
AB1
FLUOXETINE HYDROCHLORIDE
AB2 MYLAN
AB2
AB2 SANDOZ
AB2
AB2 TEVA
AB2
SARAFEM
AB2 ELI LILLY AND CO
AB2 +
CAPSULE, DELAYED REL PELLETS;ORAL
FLUOXETINE HYDROCHLORIDE
AB BARR
AB DR REDDYS LABS LTD
PROZAC WEEKLY
AB + LILLY
SOLUTION;ORAL
FLUOXETINE HYDROCHLORIDE
AA AUROBINDO PHARM
AA LANNETT
AA MALLINCKRODT
AA + PHARM ASSOC
AA SILARX
AA TEVA
AA WOCKHARDT
TABLET;ORAL
FLUOXETINE HYDROCHLORIDE
AB DR REDDYS LABS INC
AB MYLAN
AB TEVA
EDGEMONT PHARMS LLC
EQ 40MG BASE
EQ 40MG BASE
EQ 40MG BASE
EQ 40MG BASE
EQ 40MG BASE
EQ 40MG BASE
EQ 40MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 90MG BASE
EQ 90MG BASE
EQ 90MG BASE
EQ 20MG BASE/5ML
EQ 20MG BASE/5ML
EQ 20MG BASE/5ML
EQ 20MG BASE/5ML
EQ 20MG BASE/5ML
EQ 20MG BASE/5ML
EQ 20MG BASE/5ML
EQ 10MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 60MG BASE
3-156( of 362)
A075245 003 Sep 28, 2004
A075207 003 May 25, 2007
A076922 003 Dec 16, 2004
A076990 001 Dec 13, 2004
A075049 003 Jan 29, 2002
A075452 003 Jan 29, 2002
N018936 003 Jun 15, 1999
A090223 001 Mar 19, 2009
A090223 002 Mar 19, 2009
A078619 001 Jan 31, 2008
A078619 002 Jan 31, 2008
A074803 002 Jan 30, 2002
A074803 001 Aug 02, 2001
A075465 001 Jan 29, 2002
A075465 002 Jan 29, 2002
A201336 001 Oct 01, 2012
A201336 002 Oct 01, 2012
A075245 002 Jan 31, 2002
A075245 001 Jan 31, 2002
A075464 001 Jan 30, 2002
A075464 002 Jan 30, 2002
A075658 001 Jan 29, 2002
A075658 002 Jan 29, 2002
A075207 001 Jan 30, 2002
A075207 002 Jan 30, 2002
A075577 001 Jan 29, 2002
A075577 002 Jan 29, 2002
A075049 001 Aug 02, 2001
A075049 002 Jan 29, 2002
A075452 001 Jan 29, 2002
A075452 002 Jan 29, 2002
A076001 001 Jan 29, 2002
A076001 002 Jan 29, 2002
N018936 006 Dec 23, 1992
N018936 001 Dec 29, 1987
A078045 001 Nov 17, 2008
A078045 002 Nov 17, 2008
A077469 001 Nov 17, 2008
A077469 002 Nov 17, 2008
A076287 001 May 20, 2008
A076287 002 May 20, 2008
N018936 007 Jul 06, 2000
N018936 008 Jul 06, 2000
A076237 001 Mar 24, 2010
A078572 001 Mar 22, 2010
N021235 001 Feb 26, 2001
A079209 001 Mar 20, 2009
A076458 001 May 14, 2004
A075920 001 Jan 29, 2002
A076015 001 Jan 30, 2002
A077849 001 Feb 09, 2007
A075506 001 Aug 02, 2001
A075514 001 Aug 29, 2002
A076006 001 Jan 30, 2002
A075755 001 Aug 02, 2001
A075872 001 Jan 29, 2002
N202133 001 Oct 06, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
FLUOXETINE HYDROCHLORIDE
TABLET;ORAL
FLUOXETINE HYDROCHLORIDE
+ MYLAN EQ 20MG BASE
SARAFEM
WARNER CHILCOTT LLC EQ 10MG BASE
EQ 15MG BASE
+ EQ 20MG BASE
FLUOXETINE HYDROCHLORIDE; OLANZAPINE
CAPSULE;ORAL
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
AB PAR PHARM
AB
AB
AB
AB
AB SANDOZ
AB
AB
AB
AB
AB TEVA PHARMS
AB
AB
AB
AB
SYMBYAX
AB LILLY
AB
AB
AB +
AB
FLUOXYMESTERONE
TABLET;ORAL
FLUOXYMESTERONE
+ USL PHARMA
FLUPHENAZINE DECANOATE
INJECTABLE;INJECTION
FLUPHENAZINE DECANOATE
AO BEDFORD
AO + FRESENIUS KABI USA
FLUPHENAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
FLUPHENAZINE HYDROCHLORIDE
+ PHARM ASSOC
ELIXIR;ORAL
FLUPHENAZINE HYDROCHLORIDE
+ PHARM ASSOC
INJECTABLE;INJECTION
FLUPHENAZINE HYDROCHLORIDE
+ FRESENIUS KABI USA
TABLET;ORAL
FLUPHENAZINE HYDROCHLORIDE
AB LANNETT
AB
AB
AB
AB MYLAN
AB
AB
AB +
AB SANDOZ
AB
AB
AB
EQ 25MG BASE;EQ 3MG BASE
EQ 25MG BASE;EQ 6MG BASE
EQ 25MG BASE;EQ 12MG BASE
EQ 50MG BASE;EQ 6MG BASE
EQ 50MG BASE;EQ 12MG BASE
EQ 25MG BASE;EQ 3MG BASE
EQ 25MG BASE;EQ 6MG BASE
EQ 25MG BASE;EQ 12MG BASE
EQ 50MG BASE;EQ 6MG BASE
EQ 50MG BASE;EQ 12MG BASE
EQ 25MG BASE;EQ 3MG BASE
EQ 25MG BASE;EQ 6MG BASE
EQ 25MG BASE;EQ 12MG BASE
EQ 50MG BASE;EQ 6MG BASE
EQ 50MG BASE;EQ 12MG BASE
EQ 25MG BASE;EQ 3MG BASE
EQ 25MG BASE;EQ 6MG BASE
EQ 25MG BASE;EQ 12MG BASE
EQ 50MG BASE;EQ 6MG BASE
EQ 50MG BASE;EQ 12MG BASE
10MG
25MG/ML
25MG/ML
5MG/ML
2.5MG/5ML
2.5MG/ML
1MG
2.5MG
5MG
10MG
1MG
2.5MG
5MG
10MG
1MG
2.5MG
5MG
10MG
3-157( of 362)
A075755 002 Aug 02, 2001
N021860 001 May 19, 2006
N021860 002 May 19, 2006
N021860 003 May 19, 2006
A077742 001 Nov 02, 2012
A077742 002 Nov 02, 2012
A077742 003 Nov 02, 2012
A077742 004 Nov 02, 2012
A077742 005 Nov 02, 2012
A078901 005 Nov 16, 2012
A078901 001 Nov 16, 2012
A078901 003 Nov 16, 2012
A078901 002 Nov 16, 2012
A078901 004 Nov 16, 2012
A202074 001 Mar 25, 2013
A077528 001 Jun 19, 2012
A077528 002 Jun 19, 2012
A077528 003 Jun 19, 2012
A077528 004 Jun 19, 2012
N021520 001 Apr 09, 2007
N021520 002 Dec 24, 2003
N021520 004 Dec 24, 2003
N021520 003 Dec 24, 2003
N021520 005 Dec 24, 2003
A088342 001 Oct 21, 1983
A074531 001 Aug 30, 1996
A071413 001 Jul 14, 1987
A074725 001 Sep 16, 1996
A040146 001 Aug 21, 1996
A089556 001 Apr 16, 1987
A089740 001 Aug 25, 1988
A089741 001 Aug 25, 1988
A089742 001 Aug 25, 1988
A089743 001 Aug 25, 1988
A089804 002 Aug 12, 1988
A089804 003 Aug 12, 1988
A089804 004 Aug 12, 1988
A089804 001 Aug 12, 1988
A089583 001 Oct 16, 1987
A089584 001 Oct 16, 1987
A089585 001 Oct 16, 1987
A089586 001 Oct 16, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-158( of 362)
FLURANDRENOLIDE
CREAM;TOPICAL
CORDRAN SP
+ AQUA PHARMS 0.025% N012806 003
+ 0.05% N012806 002
LOTION;TOPICAL
CORDRAN
+ AQUA PHARMS 0.05% N013790 001
TAPE;TOPICAL
CORDRAN
+ WATSON PHARMS 0.004MG/SQ CM N016455 001
FLURAZEPAM HYDROCHLORIDE
CAPSULE;ORAL
FLURAZEPAM HYDROCHLORIDE
AB MYLAN PHARMS INC 15MG A070345 002 Nov 27, 1985
AB + 30MG A070345 001 Nov 27, 1985
AB WATSON LABS 15MG A071205 001 Nov 25, 1986
AB 30MG A071068 001 Nov 25, 1986
AB 30MG A072369 001 Mar 30, 1989
FLURBIPROFEN
TABLET;ORAL
ANSAID
AB PHARMACIA AND UPJOHN 50MG N018766 002 Oct 31, 1988
AB + 100MG N018766 003 Oct 31, 1988
FLURBIPROFEN
AB CARACO 50MG A075058 001 Apr 27, 2001
AB 100MG A075058 002 Apr 27, 2001
AB MYLAN 50MG A074358 001 Jun 20, 1994
AB 100MG A074358 002 Jun 20, 1994
AB TEVA 100MG A074431 001 May 31, 1995
FLURBIPROFEN SODIUM
SOLUTION/DROPS;OPHTHALMIC
FLURBIPROFEN SODIUM
AT BAUSCH AND LOMB 0.03% A074447 001 Jan 04, 1995
OCUFEN
AT + ALLERGAN 0.03% N019404 001 Dec 31, 1986
FLUTAMIDE
CAPSULE;ORAL
FLUTAMIDE
AB + IVAX SUB TEVA PHARMS 125MG A075780 001 Sep 19, 2001
AB MYLAN 125MG A076224 001 May 09, 2003
AB PAR PHARM 125MG A075298 001 Sep 18, 2001
AB WATSON LABS INC FL 125MG A075820 001 Sep 18, 2001
FLUTEMETAMOL F-18
INJECTABLE;INTRAVENOUS
VIZAMYL
+ GE HEALTHCARE 40.5mCi/10ML (4.05mCi/ML) N203137 001 Oct 25, 2013
+ 121.5mCi/30ML (4.05mCi/ML) N203137 002 Oct 25, 2013
FLUTICASONE FUROATE
SPRAY, METERED;NASAL
VERAMYST
+ GLAXOSMITHKLINE 0.0275MG/INH N022051 001 Apr 27, 2007
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
POWDER;INHALATION
BREO ELLIPTA
+ GLAXO GRP LTD 0.1MG/INH;EQ 0.025MG BASE/INH N204275 001 May 10, 2013
FLUTICASONE PROPIONATE
AEROSOL, METERED;INHALATION
FLOVENT HFA
+ GLAXO GRP LTD 0.044MG/INH N021433 003 May 14, 2004
+ 0.11MG/INH N021433 002 May 14, 2004
+ 0.22MG/INH N021433 001 May 14, 2004
CREAM;TOPICAL
FLUTICASONE PROPIONATE
AB FOUGERA PHARMS 0.05% A076451 001 May 14, 2004
AB G AND W LABS 0.05% A077055 001 Jun 30, 2006
AB PERRIGO NEW YORK 0.05% A076793 001 May 14, 2004
AB TOLMAR 0.05% A076633 001 May 14, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-159( of 362)
FLUTICASONE PROPIONATE
LOTION;TOPICAL
CUTIVATE
AB + FOUGERA PHARMS 0.05% N021152 001 Mar 31, 2005
FLUTICASONE PROPIONATE
AB GLENMARK GENERICS 0.05% A090759 001 May 02, 2011
AB PERRIGO ISRAEL 0.05% A091553 001 Jul 30, 2013
OINTMENT;TOPICAL
CUTIVATE
AB + FOUGERA PHARMS 0.005% N019957 001 Dec 14, 1990
FLUTICASONE PROPIONATE
AB FOUGERA PHARMS 0.005% A076300 001 May 14, 2004
AB G AND W LABS 0.005% A077168 001 Mar 03, 2006
AB PERRIGO NEW YORK 0.005% A076668 001 May 14, 2004
POWDER;INHALATION
FLOVENT DISKUS 100
+ GLAXO GRP LTD 0.1MG/INH N020833 002 Sep 29, 2000
FLOVENT DISKUS 250
+ GLAXO GRP LTD 0.25MG/INH N020833 003 Sep 29, 2000
FLOVENT DISKUS 50
+ GLAXO GRP LTD 0.05MG/INH N020833 001 Sep 29, 2000
SPRAY, METERED;NASAL
FLONASE
AB + GLAXOSMITHKLINE 0.05MG/SPRAY N020121 001 Oct 19, 1994
FLUTICASONE PROPIONATE
AB APOTEX INC 0.05MG/SPRAY A077538 001 Sep 12, 2007
AB HI TECH PHARMA 0.05MG/SPRAY A077570 001 Jan 16, 2008
AB ROXANE 0.05MG/SPRAY A076504 001 Feb 22, 2006
AB WOCKHARDT 0.05MG/SPRAY A078492 001 Jan 09, 2012
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
AEROSOL, METERED;INHALATION
ADVAIR HFA
+ GLAXO GRP LTD 0.045MG/INH;EQ 0.021MG BASE/INH N021254 001 Jun 08, 2006
+ 0.115MG/INH;EQ 0.021MG BASE/INH N021254 002 Jun 08, 2006
+ 0.23MG/INH;EQ 0.021MG BASE/INH N021254 003 Jun 08, 2006
POWDER;INHALATION
ADVAIR DISKUS 100/50
+ GLAXO GRP LTD 0.1MG/INH;EQ 0.05MG BASE/INH N021077 001 Aug 24, 2000
ADVAIR DISKUS 250/50
+ GLAXO GRP LTD 0.25MG/INH;EQ 0.05MG BASE/INH N021077 002 Aug 24, 2000
ADVAIR DISKUS 500/50
+ GLAXO GRP LTD 0.5MG/INH;EQ 0.05MG BASE/INH N021077 003 Aug 24, 2000
FLUVASTATIN SODIUM
CAPSULE;ORAL
FLUVASTATIN SODIUM
AB MYLAN PHARMS INC EQ 20MG BASE A090595 001 Apr 11, 2012
AB EQ 40MG BASE A090595 002 Apr 11, 2012
AB TEVA PHARMS EQ 20MG BASE A078407 001 Jun 12, 2012
AB EQ 40MG BASE A078407 002 Jun 12, 2012
LESCOL
AB NOVARTIS EQ 20MG BASE N020261 001 Dec 31, 1993
AB + EQ 40MG BASE N020261 002 Dec 31, 1993
TABLET, EXTENDED RELEASE;ORAL
LESCOL XL
+ NOVARTIS 80MG N021192 001 Oct 06, 2000
FLUVOXAMINE MALEATE
CAPSULE, EXTENDED RELEASE;ORAL
FLUVOXAMINE MALEATE
AB ACTAVIS ELIZABETH 100MG A091482 001 Apr 23, 2013
AB 150MG A091482 002 Nov 18, 2013
AB ANCHEN PHARMS 100MG A091476 001 Mar 13, 2013
AB 150MG A091476 002 Mar 13, 2013
LUVOX CR
AB JAZZ PHARMS 100MG N022033 001 Feb 28, 2008
AB + 150MG N022033 002 Feb 28, 2008
TABLET;ORAL
FLUVOXAMINE MALEATE
AB APOTEX 25MG A075902 001 May 07, 2001
AB 50MG A075902 002 May 07, 2001
AB 100MG A075902 003 May 07, 2001
AB BARR 25MG A075897 001 Jan 25, 2001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-160( of 362)
FLUVOXAMINE MALEATE
TABLET;ORAL
FLUVOXAMINE MALEATE
AB 50MG A075897 002 Jan 25, 2001
AB 100MG A075897 003 Jan 25, 2001
AB MYLAN 25MG A075889 001 Nov 29, 2000
AB 50MG A075889 002 Nov 29, 2000
AB 100MG A075889 003 Nov 29, 2000
AB SANDOZ 25MG A075888 001 Nov 29, 2000
AB 50MG A075888 002 Nov 29, 2000
AB + 100MG A075888 003 Nov 29, 2000
AB TEVA 25MG A075893 001 Sep 10, 2002
AB 50MG A075893 002 Sep 10, 2002
AB 100MG A075893 003 Sep 10, 2002
LUVOX
AB ANI PHARMS 25MG N021519 001 Dec 20, 2007
AB 50MG N021519 002 Dec 20, 2007
AB 100MG N021519 003 Dec 20, 2007
FOLIC ACID
INJECTABLE;INJECTION
FOLIC ACID
+ FRESENIUS KABI USA 5MG/ML A089202 001 Feb 18, 1986
TABLET;ORAL
FOLIC ACID
AA + AMNEAL PHARM 1MG A040625 001 Jul 21, 2005
AA BICON PHARM 1MG A091145 001 Jul 12, 2013
AA CONTRACT PHARMACAL 1MG A085061 001
AA EXCELLIUM 1MG A040796 001 Jan 12, 2009
AA INVAGEN PHARMS 1MG A090035 001 Jun 09, 2009
AA JUBILANT CADISTA 1MG A040514 001 Jun 14, 2005
AA VINTAGE 1MG A040756 001 Jun 04, 2010
AA + WATSON LABS 1MG A080680 001
AA WEST WARD 1MG A080600 001
FOLLITROPIN ALFA/BETA
INJECTABLE;SUBCUTANEOUS
FOLLISTIM AQ
+ ORGANON USA INC 75 IU/0.5ML N021273 001 Aug 26, 2005
+ 150 IU/0.5ML N021273 002 Aug 26, 2005
+ 300 IU/0.36ML N021211 001 Mar 23, 2004
+ 600 IU/0.72ML N021211 002 Mar 23, 2004
+ 900 IU/1.08ML N021211 004 Feb 11, 2005
GONAL-F
+ EMD SERONO 450 IU/VIAL N020378 005 Mar 26, 2004
1,050 IU/VIAL N020378 004 Feb 28, 2001
GONAL-F RFF
+ EMD SERONO 75 IU/VIAL N021765 002 Mar 25, 2004
GONAL-F RFF PEN
+ EMD SERONO 300 IU/0.5ML N021684 001 May 25, 2004
+ 450 IU/0.75ML N021684 002 May 25, 2004
+ 900 IU/1.5ML N021684 003 May 25, 2004
FOMEPIZOLE
INJECTABLE;INJECTION
ANTIZOL
AP + PALADIN LABS 1.5GM/1.5ML (1GM/ML) N020696 001 Dec 04, 1997
FOMEPIZOLE
AP LUITPOLD 1.5GM/1.5ML (1GM/ML) A078368 001 Dec 14, 2007
AP MYLAN INSTITUTIONAL 1.5GM/1.5ML (1GM/ML) A079033 001 Apr 07, 2009
AP 1.5GM/1.5ML (1GM/ML) A078639 001 Mar 03, 2008
AP NAVINTA LLC 1.5GM/1.5ML (1GM/ML) A078537 001 Mar 06, 2008
FONDAPARINUX SODIUM
INJECTABLE;SUBCUTANEOUS
ARIXTRA
AP + GLAXOSMITHKLINE 2.5MG/0.5ML N021345 001 Dec 07, 2001
AP + 5MG/0.4ML N021345 002 May 28, 2004
AP + 7.5MG/0.6ML N021345 003 May 28, 2004
AP + 10MG/0.8ML N021345 004 May 28, 2004
FONDAPARINUX SODIUM
AP DR REDDYS LABS LTD 2.5MG/0.5ML A091316 001 Jul 11, 2011
AP 5MG/0.4ML A091316 002 Jul 11, 2011
AP 7.5MG/0.6ML A091316 003 Jul 11, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
FONDAPARINUX SODIUM
INJECTABLE;SUBCUTANEOUS
FONDAPARINUX SODIUM
AP
FORMOTEROL FUMARATE
POWDER;INHALATION
FORADIL
+ NOVARTIS
SOLUTION;INHALATION
PERFOROMIST
+ MYLAN SPECLT
PRESCRIPTION DRUG PRODUCT LIST
10MG/0.8ML
0.012MG/INH
0.02MG/2ML
FORMOTEROL FUMARATE; MOMETASONE FUROATE
AEROSOL, METERED;INHALATION
DULERA
+ MERCK SHARP DOHME
+
FOSAMPRENAVIR CALCIUM
SUSPENSION;ORAL
LEXIVA
+ VIIV HLTHCARE
TABLET;ORAL
LEXIVA
+ VIIV HLTHCARE
FOSAPREPITANT DIMEGLUMINE
POWDER;INTRAVENOUS
EMEND
+ MERCK AND CO INC
FOSCARNET SODIUM
INJECTABLE;INJECTION
FOSCARNET SODIUM
AP HOSPIRA
FOSCAVIR
AP + CLINIGEN HLTHCARE
FOSFOMYCIN TROMETHAMINE
FOR SUSPENSION;ORAL
MONUROL
+ ZAMBON SPA
FOSINOPRIL SODIUM
TABLET;ORAL
FOSINOPRIL SODIUM
AB APOTEX INC
AB
AB
AB AUROBINDO PHARMA LTD
AB
AB
AB INVAGEN PHARMS
AB
AB
AB SANDOZ
AB
AB
AB TEVA
AB
AB +
AB WATSON LABS
AB
AB
AB WATSON LABS FLORIDA
AB
AB
0.005MG/INH;0.1MG/INH
0.005MG/INH;0.2MG/INH
EQ 50MG BASE/ML
EQ 700MG BASE
EQ 150MG BASE/VIAL
2.4GM/100ML
2.4GM/100ML
EQ 3GM BASE/PACKET
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
3-161( of 362)
A091316 004 Jul 11, 2011
N020831 001 Feb 16, 2001
N022007 001 May 11, 2007
N022518 001 Jun 22, 2010
N022518 002 Jun 22, 2010
N022116 001 Jun 14, 2007
N021548 001 Oct 20, 2003
N022023 002 Nov 12, 2010
A077174 001 May 31, 2005
N020068 001 Sep 27, 1991
N050717 001 Dec 19, 1996
A076906 001 May 17, 2005
A076906 002 May 17, 2005
A076906 003 May 17, 2005
A091163 001 Mar 30, 2011
A091163 002 Mar 30, 2011
A091163 003 Mar 30, 2011
A077222 001 Apr 20, 2005
A077222 002 Apr 20, 2005
A077222 003 Apr 20, 2005
A076483 001 Apr 23, 2004
A076483 002 Apr 23, 2004
A076483 003 Apr 23, 2004
A076139 001 Nov 25, 2003
A076139 002 Nov 25, 2003
A076139 003 Nov 25, 2003
A077531 001 Aug 31, 2006
A077531 002 Aug 31, 2006
A077531 003 Aug 31, 2006
A076620 001 Oct 15, 2004
A076620 002 Oct 15, 2004
A076620 003 Oct 15, 2004
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
TABLET;ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
AB AUROBINDO PHARMA 10MG;12.5MG A079245 001 Jul 09, 2009
AB 20MG;12.5MG A079245 002 Jul 09, 2009
AB INVAGEN PHARMS 10MG;12.5MG A090228 001 Jul 09, 2009
AB 20MG;12.5MG A090228 002 Jul 09, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-162( of 362)
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
TABLET;ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
AB RANBAXY 10MG;12.5MG A076739 001 Dec 17, 2004
AB 20MG;12.5MG A076739 002 Dec 17, 2004
AB SANDOZ 10MG;12.5MG A076961 001 Sep 28, 2005
AB 20MG;12.5MG A076961 002 Sep 28, 2005
AB WATSON LABS FLORIDA 10MG;12.5MG A076608 001 Dec 03, 2004
AB 20MG;12.5MG A076608 002 Dec 03, 2004
FOSINOPRIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
AB EMCURE PHARMS INDIA 10MG;12.5MG A079025 001 Sep 17, 2010
AB 20MG;12.5MG A079025 002 Sep 17, 2010
FOSPHENYTOIN SODIUM
INJECTABLE;INJECTION
FOSPHENYTOIN SODIUM
AP AMNEAL PHARMS EQ 50MG PNENYTOIN NA/ML A078476 001 Mar 18, 2008
AP BEDFORD EQ 50MG PHENYTOIN NA/ML A077481 001 Aug 06, 2007
AP + FRESENIUS KABI USA EQ 50MG PHENYTOIN NA/ML A078052 001 Aug 06, 2007
AP HIKMA FARMACEUTICA EQ 50MG PHENYTOIN NA/ML A078765 001 Dec 02, 2009
AP HIKMA MAPLE EQ 50MG PHENYTOIN NA/ML A077989 001 Aug 06, 2007
AP HOSPIRA EQ 50MG PHENYTOIN NA/ML A078158 001 Aug 06, 2007
AP LUITPOLD EQ 50MG PHENYTOIN NA/ML A078277 001 Aug 06, 2007
AP EQ 50MG PHENYTOIN NA/ML A090099 001 May 13, 2010
AP STRIDES ARCOLAB EQ 50MG PHENYTOIN NA/ML A078736 001 Jun 08, 2010
AP SUN PHARMA GLOBAL EQ 50MG PHENYTOIN NA/ML A078417 001 Mar 18, 2008
AP WOCKHARDT EQ 50MG PHENYTOIN NA/ML A078137 001 Aug 06, 2007
FROVATRIPTAN SUCCINATE
TABLET;ORAL
FROVA
+ ENDO PHARMS EQ 2.5MG BASE N021006 001 Nov 08, 2001
FULVESTRANT
INJECTABLE;INTRAMUSCULAR
FASLODEX
+ ASTRAZENECA 50MG/ML N021344 001 Apr 25, 2002
FUROSEMIDE
INJECTABLE;INJECTION
FUROSEMIDE
AP FRESENIUS KABI USA 10MG/ML N018902 001 May 22, 1984
AP HOSPIRA 10MG/ML A075241 001 May 28, 1999
AP 10MG/ML N018667 001 May 28, 1982
AP + LUITPOLD 10MG/ML N018579 001 Nov 30, 1983
AP WOCKHARDT 10MG/ML A077941 001 Mar 22, 2007
SOLUTION;ORAL
FUROSEMIDE
AA + ROXANE 10MG/ML A070434 001 Apr 22, 1987
AA WOCKHARDT 10MG/ML A070655 001 Oct 02, 1987
ROXANE 40MG/5ML A070433 001 Apr 22, 1987
TABLET;ORAL
FUROSEMIDE
AB EXCELLIUM 20MG A077293 001 Nov 09, 2005
AB 40MG A077293 002 Nov 09, 2005
AB 80MG A077293 003 Nov 09, 2005
AB IPCA LABS LTD 20MG A078010 001 Sep 18, 2006
AB 40MG A078010 002 Sep 18, 2006
AB 80MG A078010 003 Sep 18, 2006
AB IVAX SUB TEVA PHARMS 20MG N018413 001 Nov 30, 1983
AB 40MG N018413 002 Nov 30, 1983
AB MYLAN 20MG N018487 001
AB 40MG N018487 002
AB 80MG A070082 001 Oct 29, 1986
AB ROXANE 20MG N018823 001 Nov 10, 1983
AB 40MG N018823 002 Nov 10, 1983
AB 80MG A070086 001 Jan 24, 1986
AB SANDOZ 20MG N018569 002
AB 40MG N018569 001
AB 80MG N018569 005 Aug 14, 1984
AB VINTAGE PHARMS 20MG A076796 001 Mar 26, 2004
AB 40MG A076796 002 Mar 26, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
FUROSEMIDE
TABLET;ORAL
FUROSEMIDE
AB 80MG
AB WATSON LABS 20MG
AB 20MG
AB 20MG
AB 40MG
AB 80MG
AB 80MG
LASIX
AB SANOFI AVENTIS US 20MG
AB 40MG
AB + 80MG
GABAPENTIN
CAPSULE;ORAL
GABAPENTIN
AB ACTAVIS ELIZABETH 100MG
AB 300MG
AB 400MG
AB ALKEM 100MG
AB 300MG
AB 400MG
AB AMNEAL PHARMS NY 100MG
AB 300MG
AB 400MG
AB APOTEX INC 100MG
AB 300MG
AB 400MG
AB AUROBINDO PHARM 100MG
AB 300MG
AB 400MG
AB HIKMA 100MG
AB 300MG
AB 400MG
AB INVAGEN PHARMS 100MG
AB 300MG
AB 400MG
AB MARKSANS PHARMA 100MG
AB 300MG
AB 400MG
AB MYLAN 100MG
AB 300MG
AB 400MG
AB RANBAXY 100MG
AB 300MG
AB 400MG
AB SUN PHARM INDS LTD 100MG
AB 300MG
AB 400MG
AB TARO 100MG
AB 300MG
AB 400MG
AB TEVA PHARMS 100MG
AB 300MG
AB 400MG
AB WATSON LABS 100MG
AB 300MG
AB 400MG
NEURONTIN
AB PFIZER PHARMS 100MG
AB 300MG
AB + 400MG
SOLUTION;ORAL
GABAPENTIN
AA ACELLA PHARMS LLC 250MG/5ML
AA AMNEAL PHARMS 250MG/5ML
AA HI TECH PHARMA 250MG/5ML
AA TARO 250MG/5ML
NEURONTIN
AA + PARKE DAVIS 250MG/5ML
3-163( of 362)
A076796 003 Mar 26, 2004
A070412 001 Feb 26, 1986
A070449 001 Nov 22, 1985
A071379 001 Jan 02, 1987
A070450 001 Nov 22, 1985
A070528 001 Jan 07, 1986
A071594 001 Feb 09, 1988
N016273 002
N016273 001
N016273 003
A075350 001 Sep 12, 2003
A075350 002 Sep 12, 2003
A075350 003 Sep 12, 2003
A090858 001 Dec 17, 2010
A090858 002 Dec 17, 2010
A090858 003 Dec 17, 2010
A078428 001 Jul 25, 2007
A078428 002 Jul 25, 2007
A078428 003 Jul 25, 2007
A075360 001 Apr 06, 2005
A075360 002 Apr 06, 2005
A075360 003 Apr 06, 2005
A078787 001 Jan 31, 2008
A078787 002 Jan 31, 2008
A078787 003 Jan 31, 2008
A078150 001 Sep 25, 2007
A078150 002 Sep 25, 2007
A078150 003 Sep 25, 2007
A090705 001 Dec 30, 2009
A090705 002 Dec 30, 2009
A090705 003 Dec 30, 2009
A090007 001 Jul 21, 2011
A090007 002 Jul 21, 2011
A090007 003 Jul 21, 2011
A090158 001 Feb 14, 2011
A090158 002 Feb 14, 2011
A090158 003 Feb 14, 2011
A076606 001 Oct 07, 2005
A076606 002 Oct 07, 2005
A076606 003 Oct 07, 2005
A077242 001 Aug 24, 2006
A077242 002 Aug 24, 2006
A077242 003 Aug 24, 2006
A077261 001 Aug 02, 2013
A077261 002 Aug 02, 2013
A077261 003 Aug 02, 2013
A075435 001 Oct 08, 2004
A075435 002 Oct 08, 2004
A075435 003 Oct 08, 2004
A075485 003 May 11, 2007
A075485 002 May 11, 2007
A075485 001 May 11, 2007
N020235 001 Dec 30, 1993
N020235 002 Dec 30, 1993
N020235 003 Dec 30, 1993
A076403 001 May 01, 2012
A202024 001 Mar 23, 2012
A078974 001 Feb 18, 2011
A076672 001 Jul 03, 2013
N021129 001 Mar 02, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-164( of 362)
GABAPENTIN
TABLET;ORAL
GABAPENTIN
AB ACTAVIS ELIZABETH 600MG A075694 001 Oct 21, 2004
AB 800MG A075694 002 Oct 21, 2004
AB ALLIED PHARMA INC 600MG A203244 002 Jul 12, 2013
AB 800MG A203244 001 Jul 12, 2013
AB APOTEX INC 100MG A077894 001 Oct 10, 2006
AB 300MG A077894 002 Oct 10, 2006
AB 400MG A077894 003 Oct 10, 2006
AB 600MG A077661 004 Sep 13, 2006
AB 800MG A077661 005 Sep 13, 2006
AB AUROBINDO PHARMA LTD 600MG A200651 001 Oct 06, 2011
AB 800MG A200651 002 Oct 06, 2011
AB GLENMARK GENERICS 600MG A077662 001 Aug 18, 2006
AB 800MG A077662 002 Aug 18, 2006
AB HIKMA PHARMS 600MG A078782 001 Jul 21, 2011
AB 800MG A078782 002 Jul 21, 2011
AB INVAGEN PHARMS 600MG A202764 001 Oct 16, 2012
AB 800MG A202764 002 Oct 16, 2012
AB IVAX SUB TEVA PHARMS 100MG A076017 001 Apr 28, 2004
AB 300MG A076017 002 Apr 28, 2004
AB 400MG A076017 003 Apr 28, 2004
AB 600MG A076017 004 Apr 29, 2005
AB 800MG A076017 005 Apr 29, 2005
AB MYLAN PHARMS INC 600MG A090335 001 Jun 01, 2010
AB 800MG A090335 002 Jun 01, 2010
AB SUN PHARM INDS LTD 600MG A077525 001 Aug 24, 2006
AB 800MG A077525 002 Aug 24, 2006
AB ZYDUS PHARMS USA INC 600MG A078926 001 Feb 11, 2011
AB 800MG A078926 002 Feb 11, 2011
NEURONTIN
AB PFIZER PHARMS 600MG N020882 001 Oct 09, 1998
AB + 800MG N020882 002 Oct 09, 1998
GRALISE
BX + DEPOMED INC 300MG N022544 001 Jan 28, 2011
BX + 600MG N022544 002 Jan 28, 2011
GABAPENTIN ENACARBIL
TABLET, EXTENDED RELEASE;ORAL
HORIZANT
XENOPORT INC 300MG N022399 002 Dec 13, 2011
+ 600MG N022399 001 Apr 06, 2011
GADOBENATE DIMEGLUMINE
INJECTABLE;INTRAVENOUS
MULTIHANCE
+ BRACCO 2.645GM/5ML (529MG/ML) N021357 001 Nov 23, 2004
+ 5.29GM/10ML (529MG/ML) N021357 002 Nov 23, 2004
+ 7.935GM/15ML (529MG/ML) N021357 003 Nov 23, 2004
+ 10.58GM/20ML (529MG/ML) N021357 004 Nov 23, 2004
MULTIHANCE MULTIPACK
+ BRACCO 26.45GM/50ML (529MG/ML) N021358 001 Nov 23, 2004
+ 52.9GM/100ML (529MG/ML) N021358 002 Nov 23, 2004
GADOBUTROL
SOLUTION;INTRAVENOUS
GADAVIST
+ BAYER HLTHCARE 1.20944GM/2ML (604.72MG/ML) N201277 006 Dec 18, 2013
+ 4.5354GM/7.5ML (604.72MG/ML) N201277 001 Mar 14, 2011
+ 6.0472GM/10ML (604.72MG/ML) N201277 002 Mar 14, 2011
+ 9.0708GM/15ML (604.72MG/ML) N201277 003 Mar 14, 2011
+ 18.1416GM/30ML (604.72MG/ML) N201277 004 Mar 14, 2011
+ 39.3068GM/65ML (604.72MG/ML) N201277 005 Mar 14, 2011
GADODIAMIDE
INJECTABLE;INJECTION
OMNISCAN
+ GE HEALTHCARE 28.7GM/100ML (287MG/ML) N022066 002 Sep 05, 2007
+ 287MG/ML N020123 001 Jan 08, 1993
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-165( of 362)
GADOFOSVESET TRISODIUM
SOLUTION;INTRAVENOUS
ABLAVAR
LANTHEUS MEDCL 2440MG/10ML (244MG/ML) N021711 001 Dec 22, 2008
+ 3660MG/15ML (244MG/ML) N021711 002 Dec 22, 2008
GADOPENTETATE DIMEGLUMINE
INJECTABLE;INJECTION
MAGNEVIST
+ BAYER HLTHCARE 469.01MG/ML N019596 001 Jun 02, 1988
+ 469.01MG/ML N021037 001 Mar 10, 2000
GADOTERATE MEGLUMINE
SOLUTION;INTRAVENOUS
DOTAREM
+ GUERBET 3.769GM/10ML (376.9MG/ML) N204781 002 Mar 20, 2013
+ 5.6535GM/15ML (376.9MG/ML) N204781 003 Mar 20, 2013
+ 7.538GM/20ML (376.9MG/ML) N204781 004 Mar 20, 2013
+ 37.69GM/100ML (376.9MG/ML) N204781 001 Mar 20, 2013
GADOTERIDOL
INJECTABLE;INJECTION
PROHANCE
+ BRACCO 279.3MG/ML N020131 001 Nov 16, 1992
PROHANCE MULTIPACK
+ BRACCO 279.3MG/ML N021489 001 Oct 09, 2003
GADOVERSETAMIDE
INJECTABLE;INJECTION
OPTIMARK
+ MALLINCKRODT 16.545GM/50ML (330.9MG/ML) N020975 001 Dec 08, 1999
+ 1654.5MG/5ML (330.9MG/ML) N020937 001 Dec 08, 1999
+ 3309MG/10ML (330.9MG/ML) N020937 002 Dec 08, 1999
+ 4963.5MG/15ML (330.9MG/ML) N020937 003 Dec 08, 1999
+ 6618MG/20ML (330.9MG/ML) N020937 004 Dec 08, 1999
OPTIMARK IN PLASTIC CONTAINER
+ MALLINCKRODT 3309MG/10ML (330.9MG/ML) N020976 002 Dec 08, 1999
+ 4963.5MG/15ML (330.9MG/ML) N020976 003 Dec 08, 1999
+ 6618MG/20ML (330.9MG/ML) N020976 004 Dec 08, 1999
+ 9927MG/30ML (330.9MG/ML) N020976 001 Dec 08, 1999
GADOXETATE DISODIUM
SOLUTION;INTRAVENOUS
EOVIST
+ BAYER HLTHCARE 1.8143GM/10ML (181.43MG/ML) N022090 001 Jul 03, 2008
2.72145GM/15ML (181.43MG/ML) N022090 002 Feb 04, 2013
GALANTAMINE HYDROBROMIDE
CAPSULE, EXTENDED RELEASE;ORAL
GALANTAMINE HYDROBROMIDE
AB BARR EQ 8MG BASE A078189 001 Sep 15, 2008
AB EQ 16MG BASE A078189 002 Sep 15, 2008
AB EQ 24MG BASE A078189 003 Sep 15, 2008
AB IMPAX LABS EQ 8MG BASE A078484 001 May 27, 2009
AB EQ 16MG BASE A078484 002 May 27, 2009
AB EQ 24MG BASE A078484 003 May 27, 2009
AB MYLAN EQ 8MG BASE A090900 001 Jan 24, 2011
AB EQ 16MG BASE A090900 002 Jan 24, 2011
AB EQ 24MG BASE A090900 003 Jan 24, 2011
AB SUN PHARMA GLOBAL EQ 8MG BASE A090178 001 Feb 02, 2011
AB EQ 16MG BASE A090178 002 Feb 02, 2011
AB EQ 24MG BASE A090178 003 Feb 02, 2011
AB WATSON LABS EQ 8MG BASE A079028 001 Dec 15, 2008
AB EQ 16MG BASE A079028 002 Dec 15, 2008
AB EQ 24MG BASE A079028 003 Dec 15, 2008
RAZADYNE ER
AB + JANSSEN PHARMS EQ 8MG BASE N021615 001 Apr 01, 2005
AB EQ 16MG BASE N021615 002 Apr 01, 2005
AB EQ 24MG BASE N021615 003 Apr 01, 2005
SOLUTION;ORAL
GALANTAMINE HYDROBROMIDE
AA ROXANE 4MG/ML A078185 001 Jan 30, 2009
RAZADYNE
AA + JANSSEN PHARMS 4MG/ML N021224 001 Jun 22, 2001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
GALANTAMINE HYDROBROMIDE
TABLET;ORAL
GALANTAMINE HYDROBROMIDE
AB APOTEX INC
AB
AB
AB AUROBINDO PHARMA LTD
AB
AB
AB BARR
AB
AB
AB DR REDDYS LABS LTD
AB
AB
AB MYLAN
AB
AB
AB
AB
AB
AB ROXANE
AB
AB
AB SANDOZ
AB
AB
AB TEVA PHARMS
AB
AB
AB ZYDUS PHARMS USA INC
AB
AB
RAZADYNE
AB + JANSSEN PHARMS
AB
AB
GALLIUM CITRATE GA-67
INJECTABLE;INJECTION
GALLIUM CITRATE GA 67
BS LANTHEUS MEDCL
BS MALLINCKRODT
GANCICLOVIR
GEL;OPHTHALMIC
ZIRGAN
+ BAUSCH AND LOMB
GANCICLOVIR SODIUM
INJECTABLE;INJECTION
CYTOVENE
AP + ROCHE PALO
GANCICLOVIR
AP FRESENIUS KABI USA
AP LUITPOLD
GANIRELIX ACETATE
INJECTABLE;INJECTION
GANIRELIX ACETATE
+ ORGANON USA INC
GATIFLOXACIN
SOLUTION/DROPS;OPHTHALMIC
GATIFLOXACIN
AT LUPIN LTD
ZYMAR
AT + ALLERGAN
ZYMAXID
AT + ALLERGAN
EQ 4MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 12MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 12MG BASE
2mCi/ML
2mCi/ML
0.15%
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 250MCG BASE/0.5ML
0.5%
0.3%
0.5%
3-166( of 362)
A077781 001 Sep 27, 2011
A077781 002 Sep 27, 2011
A077781 003 Sep 27, 2011
A090957 001 Mar 29, 2011
A090957 002 Mar 29, 2011
A090957 003 Mar 29, 2011
A077605 001 Aug 28, 2008
A077605 002 Aug 28, 2008
A077605 003 Aug 28, 2008
A077593 001 Sep 11, 2008
A077593 002 Sep 11, 2008
A077593 003 Sep 11, 2008
A077590 001 May 29, 2009
A077603 001 Aug 28, 2008
A077590 002 May 29, 2009
A077603 002 Aug 28, 2008
A077590 003 May 29, 2009
A077603 003 Aug 28, 2008
A077608 001 Feb 11, 2009
A077608 002 Feb 11, 2009
A077608 003 Feb 11, 2009
A077589 001 Jun 22, 2009
A077589 002 Jun 22, 2009
A077589 003 Jun 22, 2009
A077587 001 Jul 09, 2009
A077587 002 Jul 09, 2009
A077587 003 Jul 09, 2009
A078898 001 Feb 17, 2011
A078898 002 Feb 17, 2011
A078898 003 Feb 17, 2011
N021169 001 Feb 28, 2001
N021169 002 Feb 28, 2001
N021169 003 Feb 28, 2001
N017478 001
N018058 001
N022211 001 Sep 15, 2009
N019661 001 Jun 23, 1989
A090658 001 Jun 21, 2010
A202624 001 Sep 18, 2013
N021057 001 Jul 29, 1999
A202653 001 Aug 28, 2013
N021493 001 Mar 28, 2003
N022548 001 May 18, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
GEMCITABINE HYDROCHLORIDE
INJECTABLE;INJECTION
GEMCITABINE HYDROCHLORIDE
AP ACCORD HLTHCARE
AP
AP
AP ACTAVIS TOTOWA
AP
AP CIPLA LTD
AP
AP DR REDDYS LABS LTD
AP
AP
AP EMCURE PHARMS LTD
AP
AP FRESENIUS KABI ONCOL
AP
AP
AP FRESENIUS KABI USA
AP HAMELN RDS GMBH
AP
AP HOSPIRA
AP
AP + HOSPIRA INC
AP JIANGSU HANSOH PHARM
AP
AP LUITPOLD
AP
AP ONCO THERAPIES LTD
AP
AP
AP SAGENT PHARMS
AP
AP SUN PHARMA GLOBAL
AP
AP TEVA PHARMS
AP
GEMZAR
AP + LILLY
AP +
GEMCITABINE HYDROCHLORIDE
+ HOSPIRA INC
+
+
GEMFIBROZIL
TABLET;ORAL
GEMFIBROZIL
AB APOTEX
AB BLU CARIBE
AB CARACO
AB DAVA PHARMS INC
AB HIKMA PHARMS
AB IMPAX PHARMS
AB INVAGEN PHARMS
AB NORTHSTAR HLTHCARE
AB TEVA
AB WATSON LABS
LOPID
AB + PFIZER PHARMS
GEMIFLOXACIN MESYLATE
TABLET;ORAL
FACTIVE
+ LG LIFE SCIENCES
GENTAMICIN SULFATE
CREAM;TOPICAL
GENTAMICIN SULFATE
AT + FOUGERA
AT PERRIGO NEW YORK
AT TARO
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 2GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 2GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 200MG BASE/VIAL
1GM/26.3ML (38MG/ML)
2GM/52.6ML (38MG/ML)
200MG/5.26ML (38MG/ML)
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
EQ 320MG BASE
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
3-167( of 362)
A091594 002 Jul 25, 2011
A091594 003 Jul 25, 2011
A091594 001 Jul 25, 2011
A079160 002 Jul 25, 2011
A079160 001 Jul 25, 2011
A078759 002 Jul 25, 2011
A078759 001 Jul 25, 2011
A091365 002 Jul 25, 2011
A202997 001 May 07, 2013
A091365 001 Jul 25, 2011
A202063 002 Sep 11, 2012
A202063 001 Sep 11, 2012
A090799 002 Jul 25, 2011
A090799 003 May 16, 2011
A090799 001 Jul 25, 2011
A090242 003 May 16, 2011
A090663 002 Sep 10, 2012
A090663 001 Sep 10, 2012
A078339 002 Jul 25, 2011
A078339 001 Jul 25, 2011
A079183 001 Nov 15, 2010
A202485 002 May 07, 2013
A202485 001 May 07, 2013
A202031 002 May 07, 2013
A202031 001 May 07, 2013
A200145 002 Jul 25, 2011
A200145 003 Jul 25, 2011
A200145 001 Jul 25, 2011
A091597 002 May 07, 2013
A091597 001 May 07, 2013
A078433 002 Jul 25, 2011
A078433 001 Jul 25, 2011
A077983 001 Jan 25, 2011
A077983 002 Jan 25, 2011
N020509 002 May 15, 1996
N020509 001 May 15, 1996
N200795 002 Aug 04, 2011
N200795 003 Aug 04, 2011
N200795 001 Aug 04, 2011
A075034 001 Jul 20, 1998
A078012 001 Mar 26, 2007
A079239 001 Dec 29, 2008
A074270 001 Sep 27, 1993
A078599 001 Aug 16, 2010
A078207 001 Jun 01, 2007
A077836 001 Jul 27, 2006
A079072 001 Sep 13, 2010
A074256 001 Oct 31, 1993
A074442 001 Apr 28, 1995
N018422 003 Nov 20, 1986
N021158 001 Apr 04, 2003
A062531 001 Jul 05, 1984
A062307 001
A062427 001 May 26, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-168( of 362)
GENTAMICIN SULFATE
INJECTABLE;INJECTION
GENTAMICIN SULFATE
AP FRESENIUS KABI USA EQ 10MG BASE/ML A062366 002 Feb 06, 1986
AP + EQ 40MG BASE/ML A062366 001 Aug 04, 1983
AP HOSPIRA EQ 10MG BASE/ML A062420 001 Aug 15, 1983
AP EQ 10MG BASE/ML A062612 004 Feb 20, 1986
AP EQ 40MG BASE/ML A062420 002 Aug 15, 1983
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP + B BRAUN EQ 0.8MG BASE/ML A062814 001 Aug 28, 1987
AP + EQ 1.2MG BASE/ML A062814 002 Aug 28, 1987
AP + EQ 1.4MG BASE/ML A062814 003 Aug 28, 1987
AP + EQ 1.6MG BASE/ML A062814 004 Aug 28, 1987
AP + EQ 1.8MG BASE/ML A062814 005 Aug 28, 1987
AP + EQ 2MG BASE/ML A062814 006 Aug 28, 1987
AP + EQ 2.4MG BASE/ML A062814 007 Aug 28, 1987
AP + EQ 40MG BASE/100ML A062814 008 Aug 28, 1987
AP + EQ 60MG BASE/100ML A062814 009 Aug 28, 1987
AP + EQ 70MG BASE/100ML A062814 010 Aug 28, 1987
AP + EQ 80MG BASE/100ML A062814 011 Aug 28, 1987
AP + EQ 90MG BASE/100ML A062814 012 Aug 28, 1987
AP + EQ 100MG BASE/100ML A062814 013 Aug 28, 1987
AP + EQ 120MG BASE/100ML A062814 014 Aug 28, 1987
AP HOSPIRA EQ 1.2MG BASE/ML A062414 001 Aug 15, 1983
AP EQ 1.4MG BASE/ML A062414 002 Aug 15, 1983
AP EQ 1.6MG BASE/ML A062414 003 Aug 15, 1983
AP EQ 1.8MG BASE/ML A062414 004 Aug 15, 1983
AP EQ 2MG BASE/ML A062414 005 Aug 15, 1983
AP EQ 60MG BASE/100ML A062414 006 Aug 15, 1983
AP EQ 70MG BASE/100ML A062414 007 Aug 15, 1983
AP EQ 80MG BASE/100ML A062414 008 Aug 15, 1983
AP EQ 90MG BASE/100ML A062414 009 Aug 15, 1983
AP EQ 100MG BASE/100ML A062414 010 Aug 15, 1983
ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
AP BAXTER HLTHCARE EQ 0.8MG BASE/ML A062373 001 Sep 07, 1982
AP EQ 1.2MG BASE/ML A062373 007 Sep 07, 1982
AP EQ 1.6MG BASE/ML A062373 008 Sep 07, 1982
AP EQ 2MG BASE/ML A062373 009 Sep 07, 1982
AP EQ 2.4MG BASE/ML A062373 010 Sep 07, 1982
AP EQ 40MG BASE/100ML A062373 003 Sep 07, 1982
AP EQ 60MG BASE/100ML A062373 004 Sep 07, 1982
AP EQ 80MG BASE/100ML A062373 002 Sep 07, 1982
AP EQ 100MG BASE/100ML A062373 005 Sep 07, 1982
AP EQ 120MG BASE/100ML A062373 006 Sep 07, 1982
OINTMENT;OPHTHALMIC
GENTAMICIN SULFATE
AT + AKORN EQ 0.3% BASE A064093 001 Aug 31, 1995
AT PERRIGO CO TENNESSEE EQ 0.3% BASE A065024 001 Jul 30, 2004
OINTMENT;TOPICAL
GENTAMICIN SULFATE
AT FOUGERA EQ 0.1% BASE A062533 001 Oct 05, 1984
AT + PERRIGO NEW YORK EQ 0.1% BASE A062351 001 Feb 18, 1982
AT TARO EQ 0.1% BASE A062477 001 Dec 23, 1983
SOLUTION/DROPS;OPHTHALMIC
GENOPTIC
AT ALLERGAN EQ 0.3% BASE A062452 001 Oct 10, 1984
GENTAK
AT AKORN EQ 0.3% BASE A064163 001 Oct 12, 2001
GENTAMICIN SULFATE
AT AKORN EQ 0.3% BASE A062635 001 Jan 08, 1987
AT + BAUSCH AND LOMB EQ 0.3% BASE A064048 001 May 11, 1994
AT FALCON PHARMS EQ 0.3% BASE A062196 001
AT PERRIGO CO TENNESSEE EQ 0.3% BASE A065121 001 Jan 30, 2004
GENTAMICIN SULFATE; PREDNISOLONE ACETATE
OINTMENT;OPHTHALMIC
PRED-G
+ ALLERGAN EQ 0.3% BASE;0.6% N050612 001 Dec 01, 1989
SUSPENSION/DROPS;OPHTHALMIC
PRED-G
+ ALLERGAN EQ 0.3% BASE;1% N050586 001 Jun 10, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-169( of 362)
GLATIRAMER ACETATE
INJECTABLE;SUBCUTANEOUS
COPAXONE
+ TEVA PHARMS USA 20MG/ML N020622 002 Feb 12, 2002
GLIMEPIRIDE
TABLET;ORAL
AMARYL
AB + SANOFI AVENTIS US 1MG N020496 001 Nov 30, 1995
AB 2MG N020496 002 Nov 30, 1995
AB 4MG N020496 003 Nov 30, 1995
GLIMEPIRIDE
AB ACCORD HLTHCARE 1MG A078181 001 Aug 23, 2007
AB 2MG A078181 002 Aug 23, 2007
AB 4MG A078181 003 Aug 23, 2007
AB AUROBINDO PHARMA LTD 1MG A202759 001 Jun 29, 2012
AB 2MG A202759 002 Jun 29, 2012
AB 4MG A202759 003 Jun 29, 2012
AB CARLSBAD 1MG A077911 001 Sep 22, 2009
AB 2MG A077911 002 Sep 22, 2009
AB 4MG A077911 003 Sep 22, 2009
AB DR REDDYS LABS LTD 1MG A077091 001 Oct 06, 2005
AB 2MG A077091 002 Oct 06, 2005
AB 4MG A077091 003 Oct 06, 2005
AB HIKMA PHARMS 1MG A078952 001 Aug 01, 2013
AB 2MG A078952 002 Aug 01, 2013
AB 4MG A078952 003 Aug 01, 2013
AB INDOCO REMEDIES 1MG A202112 001 Apr 17, 2013
AB 2MG A202112 002 Apr 17, 2013
AB 4MG A202112 003 Apr 17, 2013
AB INVAGEN PHARMS 1MG A077295 001 Oct 06, 2005
AB 2MG A077295 002 Oct 06, 2005
AB 4MG A077295 003 Oct 06, 2005
AB MICRO LABS LTD INDIA 1MG A091220 001 Jun 29, 2012
AB 2MG A091220 002 Jun 29, 2012
AB 4MG A091220 004 Jun 29, 2012
AB 8MG A091220 006 Jun 29, 2012
AB MYLAN 1MG A077624 001 Nov 28, 2005
AB 2MG A077624 002 Nov 28, 2005
AB 4MG A077624 003 Nov 28, 2005
AB TEVA 1MG A076802 001 Oct 06, 2005
AB 2MG A076802 002 Oct 06, 2005
AB 4MG A076802 003 Oct 06, 2005
AB VINTAGE 1MG A077370 001 Dec 23, 2005
AB 2MG A077370 002 Dec 23, 2005
AB 4MG A077370 003 Dec 23, 2005
AB 8MG A077370 004 Dec 23, 2005
AB WATSON LABS 1MG A077280 001 Feb 03, 2006
AB 2MG A077280 002 Feb 03, 2006
AB 4MG A077280 003 Feb 03, 2006
AB WATSON LABS FLORIDA 1MG A076995 001 Apr 27, 2010
AB 2MG A076995 002 Apr 27, 2010
AB 4MG A076995 003 Apr 27, 2010
MICRO LABS LTD INDIA 3MG A091220 003 Jun 29, 2012
6MG A091220 005 Jun 29, 2012
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
TABLET;ORAL
DUETACT
AB + TAKEDA PHARMS USA 2MG;30MG N021925 001 Jul 28, 2006
AB 4MG;30MG N021925 002 Jul 28, 2006
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE
AB SANDOZ 2MG;30MG A201049 001 Jan 04, 2013
AB 4MG;30MG A201049 002 Jan 04, 2013
GLIMEPIRIDE; ROSIGLITAZONE MALEATE
TABLET;ORAL
AVANDARYL
+ SB PHARMCO 1MG;4MG N021700 001 Nov 23, 2005
2MG;4MG N021700 002 Nov 23, 2005
2MG;8MG N021700 004 Mar 30, 2007
4MG;4MG N021700 003 Nov 23, 2005
4MG;8MG N021700 005 Mar 30, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-170( of 362)
GLIPIZIDE
TABLET;ORAL
GLIPIZIDE
AB ACCORD HLTHCARE 5MG A074550 001 Sep 11, 1997
AB 10MG A074550 002 Sep 11, 1997
AB APOTEX 5MG A075795 001 Jun 13, 2001
AB 10MG A075795 002 Jun 13, 2001
AB CARACO 5MG A077820 001 Jul 11, 2006
AB 10MG A077820 002 Jul 11, 2006
AB IVAX SUB TEVA PHARMS 5MG A074497 001 Aug 31, 1995
AB 10MG A074497 002 Aug 31, 1995
AB MYLAN 5MG A074226 001 May 10, 1994
AB 5MG A074438 001 Jun 20, 1995
AB 10MG A074226 002 May 10, 1994
AB 10MG A074438 002 Jun 20, 1995
AB SANDOZ 5MG A074305 001 Apr 07, 1995
AB 10MG A074305 002 Apr 07, 1995
AB WATSON LABS 5MG A074223 001 Feb 27, 1995
AB 5MG A074370 001 Nov 22, 1994
AB 10MG A074223 002 Feb 27, 1995
AB 10MG A074370 002 Nov 22, 1994
GLUCOTROL
AB PFIZER 5MG N017783 001 May 08, 1984
AB + 10MG N017783 002 May 08, 1984
TABLET, EXTENDED RELEASE;ORAL
GLIPIZIDE
AB PAR PHARM 5MG A076159 002 Sep 20, 2013
AB 10MG A076159 001 Sep 20, 2013
AB WATSON LABS 2.5MG A076467 003 Mar 27, 2006
AB 5MG A076467 001 Sep 08, 2003
AB 10MG A076467 002 Nov 07, 2003
GLUCOTROL XL
AB PFIZER 2.5MG N020329 003 Aug 10, 1999
AB 5MG N020329 001 Apr 26, 1994
AB + 10MG N020329 002 Apr 26, 1994
GLIPIZIDE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
AB CARACO 2.5MG;250MG A077620 001 Jan 11, 2008
AB 2.5MG;500MG A077620 002 Jan 11, 2008
AB 5MG;500MG A077620 003 Jan 11, 2008
AB COREPHARMA 2.5MG;250MG A077507 001 Oct 27, 2005
AB 2.5MG;500MG A077507 002 Oct 27, 2005
AB 5MG;500MG A077507 003 Oct 27, 2005
AB HERITAGE PHARMS INC 2.5MG;250MG A078728 001 Jun 23, 2010
AB 2.5MG;500MG A078728 002 Jun 23, 2010
AB 5MG;500MG A078728 003 Jun 23, 2010
AB MYLAN 2.5MG;250MG A078083 001 Apr 12, 2007
AB 2.5MG;500MG A078083 002 Apr 12, 2007
AB 5MG;500MG A078083 003 Apr 12, 2007
AB TEVA PHARMS 2.5MG;250MG A077270 001 Oct 28, 2005
AB 2.5MG;500MG A077270 002 Oct 28, 2005
AB + 5MG;500MG A077270 003 Oct 28, 2005
AB ZYDUS PHARMS USA INC 2.5MG;250MG A078905 001 Jan 31, 2011
AB 2.5MG;500MG A078905 002 Jan 31, 2011
AB 5MG;500MG A078905 003 Jan 31, 2011
GLUCAGON HYDROCHLORIDE RECOMBINANT
INJECTABLE;INJECTION
GLUCAGEN
+ NOVO NORDISK EQ 1MG BASE/VIAL N020918 001 Jun 22, 1998
GLUCAGON RECOMBINANT
INJECTABLE;INJECTION
GLUCAGON
+ LILLY 1MG/VIAL N020928 001 Sep 11, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-171( of 362)
GLUTAMINE
FOR SOLUTION;ORAL
NUTRESTORE
+ EMMAUS MEDCL 5GM/PACKET N021667 001 Jun 10, 2004
GLYBURIDE
TABLET;ORAL
GLYBURIDE
AB AUROBINDO PHARMA 1.25MG A077537 001 Oct 18, 2007
AB 2.5MG A077537 002 Oct 18, 2007
AB 5MG A077537 003 Oct 18, 2007
AB COREPHARMA 1.25MG A076257 001 Jun 27, 2002
AB 2.5MG A076257 002 Jun 27, 2002
AB 5MG A076257 003 Jun 27, 2002
AB HERITAGE PHARMS INC 1.25MG A090937 001 Feb 28, 2011
AB 2.5MG A090937 002 Feb 28, 2011
AB 5MG A090937 003 Feb 28, 2011
AB TEVA 1.25MG A074388 001 Aug 29, 1995
AB 2.5MG A074388 002 Aug 29, 1995
AB + 5MG A074388 003 Aug 29, 1995
GLYBURIDE (MICRONIZED)
AB DAVA PHARMS INC 1.5MG A074591 001 Dec 22, 1997
AB 3MG A074591 002 Dec 22, 1997
AB 4.5MG A074591 003 Dec 22, 1997
AB 6MG A074591 004 Dec 22, 1997
AB HIKMA 1.5MG A075890 001 Jul 31, 2003
AB 3MG A075890 002 Jul 31, 2003
AB 6MG A075890 003 Jul 31, 2003
AB MYLAN 1.5MG A074792 001 Jun 26, 1998
AB 3MG A074792 002 Jun 26, 1998
AB 6MG A074792 003 Aug 17, 1999
AB TEVA 1.5MG A074686 001 Apr 20, 1999
AB 3MG A074686 002 Apr 20, 1999
AB 4.5MG A074686 003 Apr 20, 1999
AB 6MG A074686 004 Apr 20, 1999
GLYNASE
AB PHARMACIA AND UPJOHN 1.5MG N020051 001 Mar 04, 1992
AB 3MG N020051 002 Mar 04, 1992
AB + 6MG N020051 004 Sep 24, 1993
DIABETA
BX SANOFI AVENTIS US 1.25MG N017532 001 May 01, 1984
BX 2.5MG N017532 002 May 01, 1984
BX + 5MG N017532 003 May 01, 1984
GLYBURIDE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
GLUCOVANCE
AB BRISTOL MYERS SQUIBB 1.25MG;250MG N021178 001 Jul 31, 2000
AB + 2.5MG;500MG N021178 002 Jul 31, 2000
AB 5MG;500MG N021178 003 Jul 31, 2000
GLYBURIDE AND METFORMIN HYDROCHLORIDE
AB ACTAVIS ELIZABETH 1.25MG;250MG A076716 001 Jun 28, 2005
AB 2.5MG;500MG A076716 002 Jun 28, 2005
AB 5MG;500MG A076716 003 Jun 28, 2005
AB AUROBINDO PHARMA 1.25MG;250MG A077870 001 Nov 14, 2007
AB 2.5MG;500MG A077870 002 Nov 14, 2007
AB 5MG;500MG A077870 003 Nov 14, 2007
AB COREPHARMA 1.25MG;250MG A076731 001 Nov 19, 2004
AB 2.5MG;500MG A076731 002 Nov 19, 2004
AB 5MG;500MG A076731 003 Nov 19, 2004
AB HERITAGE PHARMS INC 1.25MG;250MG A079009 001 Jun 03, 2009
AB 2.5MG;500MG A079009 002 Jun 03, 2009
AB 5MG;500MG A079009 003 Jun 03, 2009
AB IVAX SUB TEVA PHARMS 1.25MG;250MG A076345 001 Feb 18, 2004
AB 2.5MG;500MG A076345 002 Feb 18, 2004
AB 5MG;500MG A076345 003 Feb 18, 2004
GLYCEROL PHENYLBUTYRATE
LIQUID;ORAL
RAVICTI
+ HYPERION THERAP INC 1.1GM/ML N203284 001 Feb 01, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-172( of 362)
GLYCINE
SOLUTION;IRRIGATION
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 1.5GM/100ML N017865 001
GLYCINE 1.5% IN PLASTIC CONTAINER
AT B BRAUN 1.5GM/100ML N016784 001
AT HOSPIRA 1.5GM/100ML N018315 001
GLYCOPYRROLATE
INJECTABLE;INJECTION
GLYCOPYRROLATE
AP HIKMA FARMACEUTICA 0.2MG/ML A090963 001 Sep 21, 2011
AP LUITPOLD 0.2MG/ML A089335 001 Jul 23, 1986
ROBINUL
AP + HIKMA MAPLE 0.2MG/ML N017558 001
SOLUTION;ORAL
CUVPOSA
+ MERZ PHARMS 1MG/5ML N022571 001 Jul 28, 2010
TABLET;ORAL
GLYCOPYRROLATE
AA AUROLIFE PHARMA LLC 1MG A202675 001 Apr 15, 2013
AA BOCA PHARMA LLC 1MG A090020 001 Oct 19, 2011
AA 2MG A090020 002 Oct 19, 2011
AA DR REDDYS LABS LTD 1MG A040847 001 Mar 21, 2008
AA 2MG A040847 002 Mar 21, 2008
AA EXCELLIUM 1MG A090195 001 Sep 21, 2012
AA 2MG A090195 002 Sep 21, 2012
AA NEXGEN PHARMA 1.5MG A091522 001 Mar 12, 2012
AA PAR PHARM 1MG A040653 001 Aug 31, 2006
AA 2MG A040653 002 Aug 31, 2006
AA RANBAXY 1MG A040844 001 Aug 18, 2009
AA 2MG A040844 002 Aug 18, 2009
AA VINTAGE 1MG A040821 001 Dec 29, 2008
AA 2MG A040821 002 Dec 29, 2008
ROBINUL
AA + SHIONOGI INC 1MG N012827 001
ROBINUL FORTE
AA + SHIONOGI INC 2MG N012827 002
GONADOTROPIN, CHORIONIC
INJECTABLE;INJECTION
CHORIONIC GONADOTROPIN
AP + FERRING 10,000 UNITS/VIAL N017016 007
AP + FRESENIUS KABI USA 10,000 UNITS/VIAL N017067 002
PREGNYL
AP + ORGANON USA INC 10,000 UNITS/VIAL N017692 001
GOSERELIN ACETATE
IMPLANT;IMPLANTATION
ZOLADEX
+ ASTRAZENECA EQ 3.6MG BASE N019726 001 Dec 29, 1989
+ EQ 10.8MG BASE N020578 001 Jan 11, 1996
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SOLUTION/DROPS;OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
AT + BAUSCH AND LOMB 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A064047 001 Jan 31, 1996
UNITS/ML
AT LUITPOLD 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A065187 001 Oct 28, 2005
UNITS/ML
NEOSPORIN
AT + MONARCH PHARMS 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A060582 001
UNITS/ML
GRANISETRON
FILM, EXTENDED RELEASE;TRANSDERMAL
SANCUSO
+ PROSTRAKAN INC 3.1MG/24HR N022198 001 Sep 12, 2008
GRANISETRON HYDROCHLORIDE
INJECTABLE;INJECTION
GRANISETRON HYDROCHLORIDE
AP AKORN INC EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A079119 001 Sep 10, 2009
AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A079078 001 Sep 14, 2009
AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A079078 002 Sep 14, 2009
AP BEDFORD LABS EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A077913 001 Jun 26, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
GRANISETRON HYDROCHLORIDE
INJECTABLE;INJECTION
GRANISETRON HYDROCHLORIDE
AP
AP
AP CIPLA LTD
AP
AP
AP DSM PHARMS INC
AP
AP EBEWE PHARMA
AP
AP FRESENIUS KABI USA
AP
AP HIKMA MAPLE
AP LUITPOLD
AP SAGENT AGILA
AP SAGENT STRIDES
AP
AP SANDOZ
AP
AP
AP + TEVA PHARMS USA
AP +
AP +
AP WOCKHARDT USA
AP
AP
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
AP DSM PHARMS INC
AP + FRESENIUS KABI USA
GRANISTERON HYDROCHLORIDE
AP HIKMA FARMACEUTICA
AP
SOLUTION;ORAL
GRANISETRON HYDROCHLORIDE
+ PEDIATRX
TABLET;ORAL
GRANISETRON HYDROCHLORIDE
AB APOTEX INC
AB CIPLA LTD
AB COREPHARMA
AB DR REDDYS LABS LTD
AB MYLAN
AB NATCO PHARMA
AB ORCHID HLTHCARE
AB ROXANE
AB TARO
AB + TEVA PHARMS
GRISEOFULVIN, MICROSIZE
SUSPENSION;ORAL
GRIFULVIN V
AB + VALEANT LUXEMBOURG
GRISEOFULVIN
AB ACTAVIS MID ATLANTIC
AB IVAX SUB TEVA PHARMS
AB PERRIGO CO TENNESSEE
AB VINTAGE PHARMS
TABLET;ORAL
GRIFULVIN V
AB + VALEANT LUXEMBOURG
GRISEOFULVIN
AB SANDOZ
AB SIGMAPHARM LABS LLC
SANDOZ
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 2MG BASE/10ML
EQ 1MG BASE
EQ 1MG BASE
EQ 1MG BASE
EQ 1MG BASE
EQ 1MG BASE
EQ 1MG BASE
EQ 1MG BASE
EQ 1MG BASE
EQ 1MG BASE
EQ 1MG BASE
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
500MG
500MG
500MG
250MG
3-173( of 362)
A077186 001 Jun 30, 2008
A077187 001 Jun 30, 2008
A078262 001 Dec 31, 2007
A078258 001 Jun 30, 2008
A078258 002 Jun 30, 2008
A078863 001 Jun 30, 2008
A078880 001 Jun 30, 2008
A078835 001 Jun 30, 2008
A078835 002 Jun 30, 2008
A078522 001 Dec 31, 2007
A078090 001 Jun 30, 2008
A077177 001 Dec 31, 2007
A091274 001 Sep 22, 2010
A091137 002 Apr 09, 2010
A091136 001 Apr 09, 2010
A091136 002 Apr 09, 2010
A078534 001 Apr 30, 2009
A078531 001 Apr 30, 2009
A078531 002 Apr 30, 2009
A078392 001 Dec 31, 2007
A077963 001 Jan 03, 2008
A077297 001 Jun 30, 2008
A078566 001 Feb 29, 2008
A078564 001 Jun 30, 2008
A078565 001 Jun 30, 2008
A078863 002 Jun 30, 2008
A078096 001 Jun 30, 2008
A078629 001 Dec 23, 2009
A078629 002 Dec 23, 2009
A078334 001 Feb 28, 2008
A078843 001 Feb 27, 2008
A078037 001 Feb 27, 2008
A078260 001 Dec 31, 2007
A078846 001 Feb 27, 2009
A078725 001 Jan 30, 2008
A078969 001 Jun 22, 2009
A078678 001 Feb 13, 2008
A077842 001 Dec 31, 2007
A090817 001 May 28, 2010
A078080 001 Dec 31, 2007
A062483 001 Jan 26, 1984
A065394 001 Jul 06, 2007
A065354 001 Sep 10, 2007
A065200 001 Mar 02, 2005
A065438 001 Oct 08, 2010
A062279 003
A091592 002 Aug 07, 2013
A202482 001 Oct 22, 2012
A091592 001 Aug 07, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
GRISEOFULVIN, ULTRAMICROSIZE
TABLET;ORAL
GRIS-PEG
AB PEDINOL 125MG
AB + 250MG
GRISEOFULVIN, ULTRAMICROSIZE
AB RICONPHARMA LLC
AB
GRISEOFULVIN,ULTRAMICROSIZE
AB SIGMAPHARM LABS LLC
AB
GUANABENZ ACETATE
TABLET;ORAL
GUANABENZ ACETATE
IVAX SUB TEVA PHARMS
+
GUANFACINE HYDROCHLORIDE
TABLET;ORAL
GUANFACINE HYDROCHLORIDE
AB AMNEAL PHARM
AB
AB EPIC PHARMA LLC
AB
AB MYLAN
AB
AB WATSON LABS
AB
TENEX
AB PROMIUS PHARMA
AB +
TABLET, EXTENDED RELEASE;ORAL
GUANFACINE HYDROCHLORIDE
AB ACTAVIS ELIZABETH
AB
AB
AB
INTUNIV
AB SHIRE
AB
AB
AB +
GUANIDINE HYDROCHLORIDE
TABLET;ORAL
GUANIDINE HYDROCHLORIDE
MERCK SHARP DOHME
HALCINONIDE
CREAM;TOPICAL
HALOG
+ RANBAXY
OINTMENT;TOPICAL
HALOG
+ RANBAXY
HALOBETASOL PROPIONATE
CREAM;TOPICAL
HALOBETASOL PROPIONATE
AB FOUGERA PHARMS
AB G AND W LABS
AB PERRIGO ISRAEL
AB TARO
ULTRAVATE
AB + RANBAXY
OINTMENT;TOPICAL
HALOBETASOL PROPIONATE
AB G AND W LABS
AB PERRIGO
ULTRAVATE
AB + RANBAXY
125MG
250MG
125MG
250MG
EQ 4MG BASE
EQ 8MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 3MG BASE
EQ 4MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 3MG BASE
EQ 4MG BASE
125MG
0.1%
0.1%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
3-174( of 362)
N050475 001
N050475 002
A204371 001 Jan 09, 2014
A204371 002 Jan 09, 2014
A202545 001 Oct 22, 2012
A202545 002 Oct 22, 2012
A074149 001 Apr 07, 1995
A074149 002 Apr 07, 1995
A075109 001 Nov 25, 1998
A075109 002 Nov 25, 1998
A074673 001 Feb 28, 1997
A074673 002 Feb 28, 1997
A074796 001 Jan 27, 1997
A074796 002 Jan 27, 1997
A074145 001 Oct 17, 1995
A074145 002 Oct 17, 1995
N019032 001 Oct 27, 1986
N019032 002 Nov 07, 1988
A200881 001 Oct 05, 2012
A200881 002 Oct 05, 2012
A200881 003 Oct 05, 2012
A200881 004 Oct 05, 2012
N022037 001 Sep 02, 2009
N022037 002 Sep 02, 2009
N022037 003 Sep 02, 2009
N022037 004 Sep 02, 2009
N001546 001
N017556 001
N017824 001
A077001 001 Dec 16, 2004
A078162 001 Apr 24, 2007
A077123 001 Dec 16, 2004
A077227 001 Aug 04, 2005
N019967 001 Dec 27, 1990
A077721 001 Sep 07, 2006
A076872 001 Dec 16, 2004
N019968 001 Dec 17, 1990
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-175( of 362)
HALOPERIDOL
TABLET;ORAL
HALOPERIDOL
AB MYLAN 0.5MG A070278 006 Jun 10, 1986
AB 1MG A070278 004 Jun 10, 1986
AB 2MG A070278 001 Jun 10, 1986
AB 5MG A070278 005 Jun 10, 1986
AB 10MG A070278 002 Jul 16, 2009
AB 20MG A070278 003 Jul 16, 2009
AB SANDOZ 0.5MG A071206 001 Nov 17, 1986
AB 1MG A071207 001 Nov 17, 1986
AB + 2MG A071208 001 Nov 17, 1986
AB 5MG A071209 001 Nov 17, 1986
AB 10MG A071210 001 Mar 11, 1988
AB 20MG A071211 001 Mar 11, 1988
AB ZYDUS PHARMS USA 5MG A077580 003 Nov 29, 2007
AB 10MG A077580 004 Nov 29, 2007
AB 20MG A077580 005 Nov 29, 2007
HALOPERIDOL DECANOATE
INJECTABLE;INJECTION
HALDOL
AO + JANSSEN PHARMS EQ 50MG BASE/ML N018701 001 Jan 14, 1986
AO + EQ 100MG BASE/ML N018701 002 Jan 31, 1997
HALOPERIDOL DECANOATE
AO BEDFORD EQ 50MG BASE/ML A074811 001 Jan 30, 1998
AO EQ 100MG BASE/ML A075305 001 Sep 28, 1998
AO FRESENIUS KABI USA EQ 50MG BASE/ML A074893 001 Dec 19, 1997
AO EQ 100MG BASE/ML A074893 002 Dec 19, 1997
AO TEVA PHARMS USA EQ 50MG BASE/ML A075393 001 May 11, 1999
AO EQ 100MG BASE/ML A075393 002 May 11, 1999
HALOPERIDOL LACTATE
CONCENTRATE;ORAL
HALOPERIDOL
AA PHARM ASSOC EQ 2MG BASE/ML A073037 001 Feb 26, 1993
AA SILARX EQ 2MG BASE/ML A073364 001 Sep 28, 1993
AA + TEVA PHARMS EQ 2MG BASE/ML A071617 001 Dec 01, 1988
INJECTABLE;INJECTION
HALDOL
AP + JANSSEN PHARMS EQ 5MG BASE/ML N015923 001
HALOPERIDOL
AP AGILA SPECLTS EQ 5MG BASE/ML A078347 001 Sep 14, 2009
AP BEDFORD EQ 5MG BASE/ML A075858 001 Jun 18, 2001
AP FRESENIUS KABI USA EQ 5MG BASE/ML A075689 001 Mar 09, 2001
AP GLAND PHARMA LTD EQ 5MG BASE/ML A076774 001 Aug 25, 2004
AP SAGENT PHARMS EQ 5MG BASE/ML A091637 001 Sep 02, 2011
AP EQ 5MG BASE/ML A200742 001 Sep 02, 2011
AP TEVA PHARMS USA EQ 5MG BASE/ML A076035 001 Aug 29, 2001
HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN SODIUM
AP + FRESENIUS KABI USA 1,000 UNITS/ML N017029 001
AP + 5,000 UNITS/ML N017651 006
AP + 10,000 UNITS/ML N017029 003
AP + 20,000 UNITS/ML N017029 004
AP + HIKMA MAPLE 1,000 UNITS/ML N017037 001
AP + 5,000 UNITS/ML N017037 002
AP + 10,000 UNITS/ML N017037 003
AP HOSPIRA 5,000 UNITS/ML A088100 001 Apr 28, 1983
AP HOSPIRA INC 1,000 UNITS/ML A090571 001 Aug 31, 2009
AP 5,000 UNITS/ML A090571 002 Aug 31, 2009
AP 10,000 UNITS/ML A090571 003 Aug 31, 2009
AP SAGENT PHARMS 1,000 UNITS/ML A090808 001 Jun 30, 2010
AP 5,000 UNITS/ML A090808 002 Jun 30, 2010
AP 10,000 UNITS/ML A090808 003 Jun 30, 2010
AP 20,000 UNITS/ML A090809 001 Jun 30, 2010
AP SANDOZ 1,000 UNITS/ML A091682 001 Jun 08, 2011
AP 5,000 UNITS/ML A091659 001 Jun 08, 2011
AP 5,000 UNITS/ML A091682 002 Jun 08, 2011
AP 10,000 UNITS/ML A201002 001 Jun 08, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-176( of 362)
HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 200 UNITS/100ML N018609 001 Apr 28, 1982
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP + B BRAUN 200 UNITS/100ML N019953 001 Jul 20, 1992
AP HOSPIRA 200 UNITS/100ML N018916 010 Jun 23, 1989
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
AP HOSPIRA 10,000 UNITS/100ML N019339 003 Mar 27, 1985
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 200 UNITS/100ML N018609 002 Apr 28, 1982
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP HOSPIRA 200 UNITS/100ML N018916 011 Jun 23, 1989
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 4,000 UNITS/100ML N019952 001 Jul 20, 1992
AP HOSPIRA 4,000 UNITS/100ML N019805 001 Jan 25, 1989
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 5,000 UNITS/100ML N019952 004 Jul 20, 1992
AP + 10,000 UNITS/100ML N019952 005 Jul 20, 1992
AP HOSPIRA 5,000 UNITS/100ML N019339 004 Mar 27, 1985
AP 5,000 UNITS/100ML N019805 002 Jan 25, 1989
AP 10,000 UNITS/100ML N019339 002 Mar 27, 1985
HEPARIN SODIUM IN PLASTIC CONTAINER
AP + FRESENIUS KABI USA 1,000 UNITS/ML N017029 013 Dec 05, 1985
AP + 5,000 UNITS/ML N017029 014 Dec 05, 1985
AP + 10,000 UNITS/ML N017029 015 Dec 05, 1985
AP + 20,000 UNITS/ML N017029 016 Dec 05, 1985
HEPARIN SODIUM PRESERVATIVE FREE
AP + FRESENIUS KABI USA 1,000 UNITS/ML N017029 010 Apr 28, 1986
AP + HOSPIRA 10,000 UNITS/ML A089522 001 May 04, 1987
AP SAGENT PHARMS 1,000 UNITS/ML A090810 001 Jun 30, 2010
HEPARIN SODIUM
PFIZER 1,000 UNITS/ML N201370 001 Jul 21, 2011
5,000 UNITS/ML N201370 002 Jul 21, 2011
10,000 UNITS/ML N201370 003 Jul 21, 2011
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5,000 UNITS/100ML N019339 001 Mar 27, 1985
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA 5,000 UNITS/100ML N018916 006 Jan 31, 1984
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA 5,000 UNITS/100ML N018916 007 Jan 31, 1984
10,000 UNITS/100ML N018916 008 Jan 31, 1984
HEPARIN SODIUM PRESERVATIVE FREE
PFIZER 1,000 UNITS/ML N201370 004 Jul 21, 2011
HEXACHLOROPHENE
EMULSION;TOPICAL
PHISOHEX
+ SANOFI AVENTIS US 3% N006882 001
SPONGE;TOPICAL
PRE-OP
AT + DAVIS AND GECK 480MG N017433 001
PRE-OP II
AT DAVIS AND GECK 480MG N017433 002
HEXAMINOLEVULINATE HYDROCHLORIDE
FOR SOLUTION;INTRAVESICAL
CYSVIEW KIT
+ PHOTOCURE ASA 100MG/VIAL N022555 001 May 28, 2010
HISTRELIN ACETATE
IMPLANT;SUBCUTANEOUS
SUPPRELIN LA
+ ENDO PHARM 50MG N022058 001 May 03, 2007
VANTAS
+ ENDO PHARM 50MG N021732 001 Oct 12, 2004
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
SYRUP;ORAL
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
AA ACTAVIS MID ATLANTIC 1.5MG/5ML;5MG/5ML A088017 001 Jul 05, 1983
AA + HI TECH PHARMA 1.5MG/5ML;5MG/5ML A040613 001 Feb 08, 2008
AA WOCKHARDT 1.5MG/5ML;5MG/5ML A088008 001 Mar 03, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-177( of 362)
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
TABLET;ORAL
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
AA NOVEL LABS INC 1.5MG;5MG A091528 001 Apr 20, 2011
TUSSIGON
AA + KING PHARMS 1.5MG;5MG A088508 001 Jul 30, 1985
HYALURONIDASE
INJECTABLE;INJECTION
AMPHADASE
+ AMPHASTAR PHARM 150 UNITS/ML N021665 001 Oct 26, 2004
VITRASE
+ BAUSCH AND LOMB 200 UNITS/VIAL N021640 002 Dec 02, 2004
HYALURONIDASE RECOMBINANT HUMAN
INJECTABLE;INJECTION
HYLENEX RECOMBINANT
+ HALOZYME THERAP 150 UNITS/ML N021859 001 Dec 02, 2005
HYDRALAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
HYDRALAZINE HYDROCHLORIDE
AP AKORN 20MG/ML A040730 001 Apr 21, 2009
AP FRESENIUS KABI USA 20MG/ML A040388 001 Mar 13, 2001
AP + LUITPOLD 20MG/ML A040136 001 Jun 30, 1997
AP NAVINTA LLC 20MG/ML A202938 001 Mar 28, 2013
TABLET;ORAL
HYDRALAZINE HYDROCHLORIDE
AA ACTAVIS GRP PTC 10MG A091679 001 Mar 04, 2013
AA 25MG A091679 002 Mar 04, 2013
AA 50MG A091679 003 Mar 04, 2013
AA 100MG A091679 004 Mar 04, 2013
AA ALKEM LABS LTD 10MG A200737 001 Dec 07, 2012
AA 25MG A200737 002 Dec 07, 2012
AA 50MG A200737 003 Dec 07, 2012
AA 100MG A200737 004 Dec 07, 2012
AA GLENMARK PHARMS LTD 10MG A090527 001 May 27, 2009
AA 25MG A090527 002 May 27, 2009
AA 50MG A090527 003 May 27, 2009
AA 100MG A090527 004 May 27, 2009
AA HERITAGE PHARMS INC 10MG A086242 001 Feb 04, 2010
AA 25MG A086242 003
AA 50MG A086242 002
AA 100MG A086242 004 Feb 04, 2010
AA HETERO LABS LTD III 10MG A040901 001 Sep 12, 2008
AA 25MG A040901 002 Sep 12, 2008
AA 50MG A040901 003 Sep 12, 2008
AA 100MG A040901 004 Sep 12, 2008
AA INVAGEN PHARMS 10MG A090255 001 Dec 15, 2008
AA 25MG A090255 002 Dec 15, 2008
AA 50MG A090255 003 Dec 15, 2008
AA 100MG A090255 004 Dec 15, 2008
AA MYLAN 10MG A090413 001 Dec 08, 2010
AA 25MG A090413 002 Dec 08, 2010
AA 50MG A090413 003 Dec 08, 2010
AA 100MG A090413 004 Dec 08, 2010
AA PAR PHARM 10MG A087836 001 Oct 05, 1982
AA 25MG A086961 002
AA 50MG A086962 001
AA 100MG A088391 001 Sep 27, 1983
AA + PLIVA 10MG A089097 001 Dec 18, 1985
AA + 25MG A088467 001 May 01, 1984
AA + 50MG A088468 001 May 01, 1984
AA + 100MG A089098 001 Dec 18, 1985
AA STRIDES ARCOLAB LTD 25MG A200770 001 May 03, 2013
AA 50MG A200770 002 May 03, 2013
AA 100MG A200770 003 May 03, 2013
AA WATSON LABS 25MG A084504 001
AA 50MG A084503 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
CAPSULE;ORAL
HYDRA-ZIDE
PAR PHARM 25MG;25MG
+ 50MG;50MG
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
TABLET;ORAL
BIDIL
+ ARBOR PHARMS INC
HYDROCHLOROTHIAZIDE
CAPSULE;ORAL
HYDROCHLOROTHIAZIDE
AB ALEMBIC PHARMS LTD
AB APOTEX
AB AUROBINDO PHARMA
AB IPCA LABS LTD
AB IVAX SUB TEVA PHARMS
AB JUBILANT CADISTA
AB LANNETT HOLDINGS INC
AB MYLAN
AB UNICHEM
AB VINTAGE PHARMS
MICROZIDE
AB + WATSON LABS
TABLET;ORAL
HYDROCHLOROTHIAZIDE
AB ACCORD HLTHCARE
AB
AB
AB ACTAVIS ELIZABETH
AB APOTEX
AB
AB AUROBINDO PHARMA
AB
AB CARACO
AB
AB
AB DAVA PHARMS INC
AB
AB EXCELLIUM
AB
AB HERITAGE PHARMS INC
AB
AB IPCA LABS LTD
AB
AB
AB IVAX SUB TEVA PHARMS
AB +
AB JUBILANT CADISTA
AB
AB LANNETT
AB
AB MYLAN PHARMS INC
AB
AB
AB UNICHEM
AB
AB VINTAGE PHARMS
AB
AB WEST WARD
ORETIC
AB ABBVIE
HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET;ORAL
AVALIDE
AB + SANOFI AVENTIS US
AB +
IRBESARTAN AND HYDROCHLOROTHIAZIDE
AB ALEMBIC LTD 12.5MG;150MG
AB 12.5MG;300MG
AB APOTEX INC 12.5MG;150MG
37.5MG;20MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
25MG
50MG
12.5MG
25MG
50MG
25MG
50MG
12.5MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
12.5MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
12.5MG
25MG
50MG
25MG
50MG
25MG
50MG
50MG
50MG
12.5MG;150MG
12.5MG;300MG
3-178( of 362)
A088957 001 Oct 21, 1985
A088946 001 Oct 21, 1985
N020727 001 Jun 23, 2005
A200645 001 Nov 30, 2010
A078389 001 May 16, 2008
A078164 001 Sep 18, 2007
A079237 001 Apr 02, 2009
A077005 001 Jul 13, 2005
A078391 001 Feb 11, 2008
A091662 001 Jan 27, 2012
A075640 001 Jan 28, 2000
A090510 001 Jan 19, 2010
A075907 001 Sep 17, 2002
N020504 001 Dec 27, 1996
A202556 001 Sep 24, 2012
A202556 002 Sep 24, 2012
A202556 003 Sep 24, 2012
A040707 001 Feb 27, 2007
A040774 001 Oct 03, 2007
A040774 002 Oct 03, 2007
A040780 001 Jul 20, 2007
A040780 002 Jul 20, 2007
A040857 001 May 30, 2008
A040810 001 Mar 27, 2007
A040810 002 Mar 27, 2007
A087059 001
A087068 001
A040702 001 Mar 16, 2007
A040702 002 Mar 16, 2007
A085182 002
A085182 001
A040807 001 Jul 20, 2007
A040807 002 Jul 20, 2007
A040807 003 Jul 20, 2007
A083177 001
A083177 002
A040809 001 Sep 04, 2007
A040809 002 Sep 04, 2007
A084325 001
A084324 001
A040770 001 Jan 23, 2007
A040735 002 Jan 23, 2007
A040735 003 Jan 23, 2007
A040907 001 Aug 15, 2008
A040907 002 Aug 15, 2008
A040412 001 Mar 29, 2002
A040412 002 Mar 29, 2002
A084878 001
N011971 002
N020758 002 Sep 30, 1997
N020758 003 Aug 31, 1998
A091370 001 Oct 15, 2012
A091370 002 Oct 15, 2012
A201505 001 Oct 15, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET;ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDE
AB
AB AUROBINDO PHARMA LTD
AB
AB DR REDDYS LABS LTD
AB
AB LUPIN LTD
AB
AB MACLEODS PHARMS LTD
AB
AB MYLAN PHARMS INC
AB
AB ROXANE
AB
AB SANDOZ
AB
AB TEVA
AB
AB WATSON LABS INC
AB
HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET;ORAL
12.5MG;300MG
12.5MG;150MG
12.5MG;300MG
12.5MG;150MG
12.5MG;300MG
12.5MG;150MG
12.5MG;300MG
12.5MG;150MG
12.5MG;300MG
12.5MG;150MG
12.5MG;300MG
12.5MG;150MG
12.5MG;300MG
12.5MG;150MG
12.5MG;300MG
12.5MG;150MG
12.5MG;300MG
12.5MG;150MG
12.5MG;300MG
LISINOPRIL AND HYDROCHLOROTHIAZIDE
AB APOTEX INC
AB
AB
AB AUROBINDO
AB
AB
AB HIKMA PHARMS LLC
AB
AB
AB IVAX SUB TEVA PHARMS
AB
AB
AB LUPIN
AB
AB
AB MYLAN
AB
AB
AB PRINSTON INC
AB
AB
AB RANBAXY
AB
AB
AB SANDOZ
AB
AB
AB WATSON LABS
AB
AB
PRINZIDE
AB MERCK
AB
ZESTORETIC
AB ASTRAZENECA
AB +
AB +
12.5MG;10MG
12.5MG;20MG
25MG;20MG
12.5MG;10MG
12.5MG;20MG
25MG;20MG
12.5MG;10MG
12.5MG;20MG
25MG;20MG
12.5MG;10MG
12.5MG;20MG
25MG;20MG
12.5MG;10MG
12.5MG;20MG
25MG;20MG
12.5MG;10MG
12.5MG;20MG
25MG;20MG
12.5MG;10MG
12.5MG;20MG
25MG;20MG
12.5MG;10MG
12.5MG;20MG
25MG;20MG
12.5MG;10MG
12.5MG;20MG
25MG;20MG
12.5MG;10MG
12.5MG;20MG
25MG;20MG
12.5MG;10MG
12.5MG;20MG
12.5MG;10MG
12.5MG;20MG
25MG;20MG
3-179( of 362)
A201505 002 Oct 15, 2012
A203630 001 Feb 22, 2013
A203630 002 Feb 22, 2013
A203500 001 Sep 27, 2012
A203500 002 Sep 27, 2012
A201524 001 Feb 27, 2013
A201524 002 Feb 27, 2013
A202414 001 Sep 27, 2012
A202414 002 Sep 27, 2012
A077969 001 Sep 27, 2012
A077969 002 Sep 27, 2012
A090351 001 Oct 15, 2012
A090351 002 Oct 15, 2012
A077446 001 Sep 27, 2012
A077446 002 Sep 27, 2012
A077369 001 Mar 30, 2012
A077369 002 Mar 30, 2012
A091539 001 Oct 22, 2012
A091539 002 Oct 22, 2012
A076674 001 Oct 05, 2004
A076674 002 Oct 05, 2004
A076674 003 Oct 05, 2004
A077606 001 Mar 14, 2006
A077606 002 Mar 14, 2006
A077606 003 Mar 14, 2006
A076265 001 Jul 08, 2002
A076265 002 Jul 08, 2002
A076265 003 Jul 08, 2002
A075776 001 Jul 01, 2002
A075776 002 Jul 01, 2002
A075776 003 Jul 01, 2002
A077912 001 Sep 27, 2006
A077912 002 Sep 27, 2006
A077912 003 Sep 27, 2006
A076113 001 Jul 01, 2002
A076113 002 Jul 01, 2002
A076113 003 Jul 01, 2002
A076230 001 Jul 01, 2002
A076230 002 Jul 01, 2002
A076230 003 Jul 01, 2002
A076007 001 Jul 01, 2002
A076007 002 Jul 01, 2002
A076007 003 Jul 01, 2002
A076262 001 Jul 01, 2002
A076262 002 Jul 01, 2002
A076262 003 Jul 01, 2002
A076194 003 Jul 01, 2002
A076194 001 Jul 01, 2002
A076194 002 Jul 01, 2002
N019778 003 Nov 18, 1993
N019778 001 Feb 16, 1989
N019888 003 Nov 18, 1993
N019888 001 Sep 20, 1990
N019888 002 Jul 20, 1989
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
TABLET;ORAL
HYZAAR
AB MERCK SHARP DOHME 12.5MG;50MG
AB 12.5MG;100MG
AB + 25MG;100MG
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
AB ALEMBIC PHARMS LTD 12.5MG;50MG
AB 12.5MG;100MG
N020387 001 Apr 28, 1995
N020387 003 Oct 20, 2005
N020387 002 Nov 10, 1998
A091617 001 Feb 17, 2012
A091617 002 Feb 17, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
TABLET;ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
AB
AB APOTEX
AB
AB
AB AUROBINDO PHARMA
AB
AB
AB CADISTA PHARMS
AB
AB
AB IPCA LABS LTD
AB
AB
AB LUPIN LTD
AB
AB
AB MACLEODS PHARMS LTD
AB
AB
AB MYLAN
AB
AB
AB ROXANE
AB
AB
AB SANDOZ
AB
AB
AB TEVA PHARMS
AB
AB
AB TORRENT PHARMS
AB
AB
AB WATSON LABS
AB
AB
AB ZYDUS PHARMS USA INC
AB
HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET;ORAL
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
12.5MG;100MG
25MG;100MG
12.5MG;50MG
25MG;100MG
METHYLDOPA AND HYDROCHLOROTHIAZIDE
MYLAN 15MG;250MG
+ 25MG;250MG
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
DUTOPROL
ASTRAZENECA 12.5MG;EQ 25MG TARTRATE
12.5MG;EQ 50MG TARTRATE
+ 12.5MG;EQ 100MG TARTRATE
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
TABLET;ORAL
LOPRESSOR HCT
AB US PHARMS HOLDINGS I 25MG;50MG
AB + 25MG;100MG
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
AB ALEMBIC PHARMS LTD 25MG;50MG
AB
AB
AB MYLAN
AB
AB
AB SUN PHARM INDS
AB
AB
25MG;100MG
50MG;100MG
25MG;50MG
25MG;100MG
50MG;100MG
25MG;50MG
25MG;100MG
50MG;100MG
3-180( of 362)
A091617 003 Feb 17, 2012
A090150 001 Oct 06, 2010
A090150 002 Aug 11, 2010
A090150 003 Oct 06, 2010
A091629 001 Oct 06, 2010
A091629 002 Oct 06, 2010
A091629 003 Jan 06, 2010
A201845 001 Sep 18, 2012
A201845 002 Sep 18, 2012
A201845 003 Sep 18, 2012
A201682 001 Mar 01, 2013
A201682 002 Mar 01, 2013
A201682 003 Mar 01, 2013
A078245 001 Oct 06, 2010
A078245 002 May 21, 2010
A078245 003 Oct 06, 2010
A202289 001 Aug 09, 2012
A202289 002 Aug 09, 2012
A202289 003 Aug 09, 2012
A091652 001 Oct 06, 2010
A091652 002 Apr 06, 2010
A091652 003 Oct 06, 2010
A077732 002 Oct 06, 2010
A077732 001 Apr 06, 2010
A077732 003 Oct 06, 2010
A077948 001 Oct 06, 2010
A077948 003 Aug 19, 2010
A077948 002 Oct 06, 2010
A077157 001 Apr 06, 2010
A077157 002 Apr 06, 2010
A077157 003 Apr 06, 2010
A090528 001 Oct 06, 2010
A090528 003 Apr 06, 2010
A090528 002 Oct 06, 2010
A200180 001 Jan 12, 2011
A200180 002 Jan 12, 2011
A200180 003 Jan 12, 2011
A078385 001 Oct 06, 2010
A078385 002 Oct 06, 2010
A070264 001 Jan 23, 1986
A070265 001 Jan 23, 1986
N021956 001 Aug 28, 2006
N021956 002 Aug 28, 2006
N021956 003 Aug 28, 2006
N018303 001 Dec 31, 1984
N018303 002 Dec 31, 1984
A202870 001 Nov 06, 2013
A202870 002 Nov 06, 2013
A202870 003 Nov 06, 2013
A076792 001 Aug 20, 2004
A076792 002 Aug 20, 2004
A076792 003 Aug 20, 2004
A090654 001 Jan 19, 2012
A090654 002 Jan 19, 2012
A090654 003 Jan 19, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-181( of 362)
HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
TABLET;ORAL
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB GLENMARK PHARMS 12.5MG;7.5MG A090718 001 Mar 17, 2010
AB 12.5MG;15MG A090718 002 Mar 17, 2010
AB 25MG;15MG A090718 003 Mar 17, 2010
AB TEVA 12.5MG;7.5MG A076980 001 Mar 07, 2007
AB 12.5MG;15MG A076980 003 Mar 07, 2007
AB 25MG;15MG A076980 002 Mar 07, 2007
UNIRETIC
AB UCB INC 12.5MG;7.5MG N020729 001 Jun 27, 1997
AB 12.5MG;15MG N020729 003 Feb 14, 2002
AB + 25MG;15MG N020729 002 Jun 27, 1997
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
TABLET;ORAL
BENICAR HCT
DAIICHI SANKYO 12.5MG;20MG N021532 002 Jun 05, 2003
12.5MG;40MG N021532 003 Jun 05, 2003
+ 25MG;40MG N021532 005 Jun 05, 2003
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE
TABLET;ORAL
INDERIDE-40/25
AB + WYETH PHARMS INC 25MG;40MG N018031 001
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB MYLAN 25MG;40MG A070946 001 Mar 04, 1987
AB + 25MG;80MG A070947 001 Apr 01, 1987
AB PLIVA 25MG;40MG A072042 001 Mar 14, 1988
AB 25MG;80MG A072043 001 Mar 14, 1988
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
ACCURETIC
AB PFIZER PHARMS 12.5MG;EQ 10MG BASE N020125 001 Dec 28, 1999
AB 12.5MG;EQ 20MG BASE N020125 002 Dec 28, 1999
AB + 25MG;EQ 20MG BASE N020125 003 Dec 28, 1999
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB APOTEX CORP 12.5MG;EQ 10MG BASE A091524 001 Mar 12, 2013
AB 12.5MG;EQ 20MG BASE A091524 002 Mar 12, 2013
AB 25MG;EQ 20MG BASE A091524 003 Mar 12, 2013
AB AUROBINDO PHARMA 12.5MG;EQ 10MG BASE A078450 001 Aug 24, 2007
AB 12.5MG;EQ 20MG BASE A078450 002 Aug 24, 2007
AB 25MG;EQ 20MG BASE A078450 003 Aug 24, 2007
AB INVAGEN PHARMS 12.5MG;10MG A201356 001 Apr 20, 2011
AB 12.5MG;20MG A201356 002 Apr 20, 2011
AB 25MG;20MG A201356 003 Apr 20, 2011
AB MYLAN 12.5MG;EQ 10MG BASE A077093 001 Mar 28, 2005
AB 12.5MG;EQ 20MG BASE A077093 002 Mar 28, 2005
AB 25MG;EQ 20MG BASE A077093 003 Mar 28, 2005
AB RANBAXY 12.5MG;EQ 10MG BASE A078211 001 Mar 04, 2009
AB 12.5MG;EQ 20MG BASE A078211 002 Mar 04, 2009
AB 25MG;EQ 20MG BASE A078211 003 Mar 04, 2009
QUINARETIC
AB GAVIS PHARMS 12.5MG;EQ 10MG BASE A076374 001 Mar 31, 2004
AB 12.5MG;EQ 20MG BASE A076374 002 Mar 31, 2004
AB 25MG;EQ 20MG BASE A076374 003 Mar 31, 2004
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
TABLET;ORAL
ALDACTAZIDE
AB GD SEARLE LLC 25MG;25MG N012616 004 Dec 30, 1982
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
AB MUTUAL PHARM 25MG;25MG A089534 001 Jul 02, 1987
AB MYLAN 25MG;25MG A086513 001
AB WATSON LABS 25MG;25MG A087398 001
ALDACTAZIDE
+ GD SEARLE LLC 50MG;50MG N012616 005 Dec 30, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-182( of 362)
HYDROCHLOROTHIAZIDE; TELMISARTAN
TABLET;ORAL
MICARDIS HCT
BOEHRINGER INGELHEIM 12.5MG;40MG N021162 001 Nov 17, 2000
12.5MG;80MG N021162 002 Nov 17, 2000
+ 25MG;80MG N021162 003 Apr 19, 2004
HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE;ORAL
DYAZIDE
AB + GLAXOSMITHKLINE LLC 25MG;37.5MG N016042 003 Mar 03, 1994
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
AB DURAMED PHARMS BARR 25MG;37.5MG A075052 001 Jun 18, 1999
AB IVAX SUB TEVA PHARMS 25MG;50MG A074259 001 Mar 30, 1995
AB LANNETT HOLDINGS INC 25MG;37.5MG A201407 001 Dec 09, 2011
AB MYLAN 25MG;37.5MG A074701 001 Jun 07, 1996
AB SANDOZ 25MG;37.5MG A074821 001 Jun 05, 1997
AB + 25MG;50MG A073191 001 Jul 31, 1991
TABLET;ORAL
MAXZIDE
AB + MYLAN PHARMS INC 50MG;75MG N019129 001 Oct 22, 1984
MAXZIDE-25
AB MYLAN PHARMS INC 25MG;37.5MG N019129 003 May 13, 1988
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
AB APOTEX INC 25MG;37.5MG A071251 002 May 05, 1998
AB 50MG;75MG A071251 001 Apr 17, 1988
AB PLIVA 25MG;37.5MG A074026 001 Apr 26, 1996
AB 50MG;75MG A073467 001 Jan 31, 1996
AB SANDOZ 25MG;37.5MG A073281 001 Apr 30, 1992
AB 50MG;75MG A072011 001 Jun 17, 1988
AB WATSON LABS 25MG;37.5MG A073449 001 Sep 23, 1993
AB 50MG;75MG A071851 001 Nov 30, 1988
HYDROCHLOROTHIAZIDE; VALSARTAN
TABLET;ORAL
DIOVAN HCT
AB NOVARTIS 12.5MG;80MG N020818 001 Mar 06, 1998
AB 12.5MG;160MG N020818 002 Mar 06, 1998
AB 12.5MG;320MG N020818 004 Apr 28, 2006
AB 25MG;160MG N020818 003 Jan 17, 2002
AB + 25MG;320MG N020818 005 Apr 28, 2006
VALSARTAN AND HYDROCHLOROTHIAZIDE
AB ALEMBIC LTD 12.5MG;80MG A201662 001 Mar 21, 2013
AB 12.5MG;160MG A201662 002 Mar 21, 2013
AB 12.5MG;320MG A201662 003 Mar 21, 2013
AB 25MG;160MG A201662 004 Mar 21, 2013
AB 25MG;320MG A201662 005 Mar 21, 2013
AB APOTEX INC 12.5MG;80MG A203026 001 Mar 21, 2013
AB 12.5MG;160MG A203026 002 Mar 21, 2013
AB 12.5MG;320MG A203026 003 Mar 21, 2013
AB 25MG;160MG A203026 004 Mar 21, 2013
AB 25MG;320MG A203026 005 Mar 21, 2013
AB AUROBINDO PHARMA LTD 12.5MG;80MG A202519 001 Mar 21, 2013
AB 12.5MG;160MG A202519 002 Mar 21, 2013
AB 12.5MG;320MG A202519 003 Mar 21, 2013
AB 25MG;160MG A202519 004 Mar 21, 2013
AB 25MG;320MG A202519 005 Mar 21, 2013
AB LUPIN LTD 12.5MG;80MG A078946 003 Mar 21, 2013
AB 12.5MG;160MG A078946 004 Mar 21, 2013
AB 12.5MG;320MG A078946 001 Mar 21, 2013
AB 25MG;160MG A078946 005 Mar 21, 2013
AB 25MG;320MG A078946 002 Mar 21, 2013
AB MACLEODS PHARMS LTD 12.5MG;80MG A203145 001 Apr 19, 2013
AB 12.5MG;160MG A203145 002 Apr 19, 2013
AB 12.5MG;320MG A203145 003 Apr 19, 2013
AB 25MG;160MG A203145 004 Apr 19, 2013
AB 25MG;320MG A203145 005 Apr 19, 2013
AB MYLAN PHARMS INC 12.5MG;80MG A078020 001 Sep 21, 2012
AB 12.5MG;160MG A078020 002 Sep 21, 2012
AB 12.5MG;320MG A078020 004 Sep 21, 2012
AB 25MG;160MG A078020 003 Sep 21, 2012
AB 25MG;320MG A078020 005 Sep 21, 2012
AB WATSON LABS INC 12.5MG;80MG A091519 001 Mar 21, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-183( of 362)
HYDROCHLOROTHIAZIDE; VALSARTAN
TABLET;ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDE
AB 12.5MG;160MG A091519 002 Mar 21, 2013
AB 12.5MG;320MG A091519 003 Mar 21, 2013
AB 25MG;160MG A091519 004 Mar 21, 2013
AB 25MG;320MG A091519 005 Mar 21, 2013
HYDROCODONE BITARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
ZOHYDRO ER
+ ZOGENIX INC 10MG N202880 001 Oct 25, 2013
15MG N202880 002 Oct 25, 2013
20MG N202880 003 Oct 25, 2013
30MG N202880 004 Oct 25, 2013
40MG N202880 005 Oct 25, 2013
50MG N202880 006 Oct 25, 2013
HYDROCODONE BITARTRATE; IBUPROFEN
TABLET;ORAL
HYDROCODONE BITARTRATE AND IBUPROFEN
AB AMNEAL PHARMS NY 5MG;200MG A076642 002 Mar 18, 2004
AB 7.5MG;200MG A076642 001 Oct 12, 2004
AB SUN PHARM INDS INC 2.5MG;200MG A091633 001 May 28, 2013
AB 5MG;200MG A091633 002 May 28, 2013
AB 7.5MG;200MG A091633 003 May 28, 2013
AB 10MG;200MG A091633 004 May 28, 2013
AB TEVA 7.5MG;200MG A076023 001 Apr 11, 2003
AB VINTAGE PHARMS 5MG;200MG A077727 001 Nov 06, 2006
AB 7.5MG;200MG A077723 001 Nov 06, 2006
AB 10MG;200MG A077723 002 Nov 06, 2006
AB WATSON LABS FLORIDA 5MG;200MG A077454 001 Jun 23, 2010
AB 7.5MG;200MG A076604 001 Dec 31, 2003
REPREXAIN
AB AMNEAL PHARMS NY 2.5MG;200MG A076642 003 Oct 19, 2007
AB 10MG;200MG A076642 004 Oct 19, 2007
VICOPROFEN
AB + ABBVIE 7.5MG;200MG N020716 001 Sep 23, 1997
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
SOLUTION;ORAL
REZIRA
+ CYPRESS PHARM 5MG/5ML;60MG/5ML N022442 001 Jun 08, 2011
HYDROCORTISONE
CREAM;TOPICAL
ALA-CORT
AT CROWN LABS 1% A080706 006
ANUSOL HC
AT SALIX PHARMS 2.5% A088250 001 Jun 06, 1984
HYDROCORTISONE
AT ACTAVIS MID ATLANTIC 1% A087795 001 May 03, 1983
AT 2.5% A089682 001 Mar 10, 1988
AT + FOUGERA 1% A080693 003
AT + 2.5% A089414 001 Dec 16, 1986
AT LYNE 2.5% A040879 001 Aug 20, 2010
AT PERRIGO NEW YORK 2.5% A085025 001
AT TARO 1% A086155 001
AT 2.5% A088799 001 Nov 09, 1984
AT VINTAGE PHARMS 2.5% A040503 001 Mar 12, 2004
SYNACORT
AT MEDICIS 1% A087458 001
AT 2.5% A087457 001
ENEMA;RECTAL
COLOCORT
AB PADDOCK LLC 100MG/60ML A075172 001 Dec 03, 1999
CORTENEMA
AB + ANI PHARMS 100MG/60ML N016199 001
HYDROCORTISONE
AB TEVA PHARMS 100MG/60ML A074171 001 May 27, 1994
LOTION;TOPICAL
ALA-CORT
AT CROWN LABS 1% A083201 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-184( of 362)
HYDROCORTISONE
LOTION;TOPICAL
HYDROCORTISONE
AT
AT
AT
+ FOUGERA PHARMS
TARO
VINTAGE PHARMS
NUTRACORT
2.5%
2.5%
2.5%
A040351 001 Jul 25, 2000
A040247 001 Jul 23, 1999
A040417 001 Jul 30, 2003
AT DOW PHARM 1% A080443 003
AT
STIE-CORT
2.5% A087644 001 Aug 24, 1982
AT PERRIGO
ALA-SCALP
2.5% A089074 001 Nov 26, 1985
CROWN LABS 2% A083231 001
OINTMENT;TOPICAL
HYDROCORTISONE
AT
AT
AT
+
+
ACTAVIS MID ATLANTIC
FOUGERA
FOUGERA PHARMS
1%
2.5%
1%
A087796 001 Oct 13, 1982
A081203 001 May 28, 1993
A080692 001
AT PERRIGO NEW YORK 2.5% A085027 001
AT TARO 1% A086257 001
HYDROCORTISONE IN ABSORBASE
AT CAROLINA MEDCL
POWDER;FOR RX COMPOUNDING
HYDRO-RX
1% A088138 001 Sep 06, 1985
+ X GEN PHARMS 100% A085982 001
SOLUTION;TOPICAL
TEXACORT
MISSION PHARMA +
TABLET;ORAL
CORTEF
2.5% A081271 001 Apr 17, 1992
AB PHARMACIA AND UPJOHN 5MG N008697 003
AB 10MG N008697 001
AB + 20MG N008697 002
HYDROCORTISONE
AB
AB
AB
AB
AB
AB
AMEDRA PHARMS
VINTAGE
5MG
10MG
20MG
5MG
10MG
20MG
A040646 001 Mar 30, 2007
A040646 002 Mar 30, 2007
A040646 003 Mar 30, 2007
A040761 001 Jul 16, 2007
A040761 002 Jul 16, 2007
A040761 003 Jul 16, 2007
HYDROCORTISONE ACETATE
AEROSOL, METERED;RECTAL
CORTIFOAM
MEDA PHARMS +
CREAM;TOPICAL
HYDROCORTISONE ACETATE
10% N017351 001 Feb 10, 1982
FERNDALE LABS +
MICORT-HC
2.5% A040259 001 Jul 29, 1999
SEBELA IRELAND LTD +
POWDER;FOR RX COMPOUNDING
HYDROCORTISONE ACETATE
2%
2.5%
A040398 001
A040396 001
Mar 29, 2002
Feb 27, 2001
X GEN PHARMS 100% A085981 001
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
CREAM;TOPICAL
CORTISPORIN
+ MONARCH PHARMS 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM N050218 001 Aug 09, 1985
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
AEROSOL, METERED;TOPICAL
EPIFOAM
BX MEDA PHARMS 1%;1% A086457 001
PROCTOFOAM HC
BX MEDA PHARMS 1%;1% A086195 001
CREAM;TOPICAL
PRAMOSONE
SEBELA IRELAND LTD 0.5%;1% A083778 001
1%;1% A085368 001
LOTION;TOPICAL
PRAMOSONE
SEBELA IRELAND LTD 1%;1% A085980 001
2.5%;1% A085979 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-185( of 362)
HYDROCORTISONE ACETATE; UREA
CREAM;TOPICAL
U-CORT
TARO 1%;10% A089472 001 Jun 13, 1988
HYDROCORTISONE BUTYRATE
CREAM;TOPICAL
HYDROCORTISONE BUTYRATE
AB GLENMARK GENERICS 0.1% A202145 001 Sep 27, 2013
AB TARO PHARM INDS 0.1% A076654 001 Aug 03, 2005
LOCOID
AB + PRECISION DERMAT 0.1% N018514 001 Mar 31, 1982
LOCOID LIPOCREAM
AB + PRECISION DERMAT 0.1% N020769 001 Sep 08, 1997
LOTION;TOPICAL
LOCOID
+ PRECISION DERMAT 0.1% N022076 001 May 18, 2007
OINTMENT;TOPICAL
HYDROCORTISONE BUTYRATE
AB TARO 0.1% A076842 001 Dec 27, 2004
LOCOID
AB + PRECISION DERMAT 0.1% N018652 001 Oct 29, 1982
SOLUTION;TOPICAL
HYDROCORTISONE BUTYRATE
AT TARO PHARM INDS 0.1% A076364 001 Jan 14, 2004
LOCOID
AT + PRECISION DERMAT 0.1% N019116 001 Feb 25, 1987
HYDROCORTISONE PROBUTATE
CREAM;TOPICAL
PANDEL
+ FOUGERA PHARMS 0.1% N020453 001 Feb 28, 1997
HYDROCORTISONE SODIUM SUCCINATE
INJECTABLE;INJECTION
A-HYDROCORT
AP HOSPIRA EQ 100MG BASE/VIAL A040666 001 Apr 06, 2006
SOLU-CORTEF
AP + PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL N009866 004
AP + EQ 100MG BASE/VIAL N009866 001
AP + EQ 250MG BASE/VIAL N009866 002
AP + EQ 500MG BASE/VIAL N009866 003
HYDROCORTISONE VALERATE
CREAM;TOPICAL
HYDROCORTISONE VALERATE
AB PERRIGO NEW YORK 0.2% A075666 001 May 24, 2000
AB + TARO 0.2% A075042 001 Aug 25, 1998
OINTMENT;TOPICAL
HYDROCORTISONE VALERATE
+ TARO 0.2% A075043 001 Aug 25, 1998
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SOLUTION/DROPS;OTIC
CORTISPORIN
AT + MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N050479 001
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
AT ALCON PHARMS LTD 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
AT BAUSCH AND LOMB 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
AT LUITPOLD 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
SUSPENSION/DROPS;OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
A062423 001 Aug 25, 1983
A064053 001 Dec 29, 1995
A065216 001 Oct 31, 2005
ALCON PHARMS LTD +
SUSPENSION/DROPS;OTIC
CORTISPORIN
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062874 001 May 11, 1988
AT + CITRON PHARMA LLC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
A060613 001
AT
AT
ALCON PHARMS LTD
LUITPOLD
OTICAIR
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062488 001 Nov 06, 1985
A065219 001 May 01, 2006
AT BAUSCH AND LOMB
PEDIOTIC
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A064065 001 Aug 28, 1996
AT MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062822 001 Sep 29, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-186( of 362)
HYDROFLUMETHIAZIDE
TABLET;ORAL
SALURON
AB + SHIRE LLC 50MG N011949 001
HYDROMORPHONE HYDROCHLORIDE
INJECTABLE;INJECTION
DILAUDID
AP + PURDUE PHARM PRODS 1MG/ML N019034 003 Apr 30, 2009
AP + 2MG/ML N019034 004 Apr 30, 2009
AP + 4MG/ML N019034 005 Apr 30, 2009
DILAUDID-HP
AP + PURDUE PHARM PRODS 10MG/ML N019034 001 Jan 11, 1984
HYDROMORPHONE HYDROCHLORIDE
AP AKORN 10MG/ML A078228 001 Apr 14, 2010
AP 10MG/ML A078261 001 Apr 14, 2010
AP BARR 10MG/ML A076444 001 Apr 25, 2003
AP HOSPIRA 10MG/ML A074598 001 Jun 19, 1997
AP HOSPIRA INC 1MG/ML N200403 001 Dec 01, 2011
AP 2MG/ML N200403 002 Dec 01, 2011
AP 4MG/ML N200403 003 Dec 01, 2011
AP 10MG/ML A078591 001 Jun 17, 2008
DILAUDID-HP
+ PURDUE PHARM PRODS 250MG/VIAL N019034 002 Aug 04, 1994
SOLUTION;ORAL
DILAUDID
AA + PURDUE PHARM PRODS 5MG/5ML N019891 001 Dec 07, 1992
HYDROMORPHONE HYDROCHLORIDE
AA ROXANE 5MG/5ML A074653 001 Jul 29, 1998
TABLET;ORAL
DILAUDID
AB PURDUE PHARM PRODS 2MG N019892 003 Nov 09, 2007
AB 4MG N019892 002 Nov 09, 2007
AB + 8MG N019892 001 Dec 07, 1992
HYDROMORPHONE HYDROCHLORIDE
AB ELITE LABS 8MG A076723 001 Oct 18, 2005
AB LANNETT 2MG A078439 001 Dec 09, 2009
AB 4MG A078439 002 Dec 09, 2009
AB 8MG A077471 001 Dec 09, 2009
AB MALLINCKRODT 8MG A076855 001 Dec 23, 2004
AB MALLINCKRODT INC 2MG A078273 001 Sep 19, 2007
AB 4MG A078273 002 Sep 19, 2007
AB ROXANE 4MG A074597 003 May 29, 2009
AB 8MG A074597 001 Jul 29, 1998
TABLET, EXTENDED RELEASE;ORAL
EXALGO
MALLINCKRODT INC 8MG N021217 001 Mar 01, 2010
12MG N021217 002 Mar 01, 2010
16MG N021217 003 Mar 01, 2010
+ 32MG N021217 004 Aug 24, 2012
HYDROXOCOBALAMIN
INJECTABLE;INJECTION
CYANOKIT
+ MERCK SANTE SAS 5GM/VIAL (5GM/KIT) N022041 001 Apr 08, 2011
HYDROXOCOBALAMIN
+ WATSON LABS 1MG/ML A085998 001
HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE
SOLUTION/DROPS;OPHTHALMIC
PAREMYD
+ AKORN 1%;0.25% N019261 001 Jan 30, 1992
HYDROXYCHLOROQUINE SULFATE
TABLET;ORAL
HYDROXYCHLOROQUINE SULFATE
AB IPCA LABS LTD 200MG A040766 001 Jun 14, 2007
AB MYLAN 200MG A040274 001 May 29, 1998
AB SANDOZ 200MG A040104 001 Nov 30, 1995
AB TEVA PHARMS 200MG A040081 001 Sep 30, 1994
AB WATSON LABS 200MG A040133 001 Nov 30, 1995
AB WEST WARD 200MG A040760 001 Aug 15, 2007
AB ZYDUS PHARMS USA INC 200MG A040657 001 Sep 21, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-187( of 362)
HYDROXYCHLOROQUINE SULFATE
TABLET;ORAL
PLAQUENIL
AB + SANOFI AVENTIS US 200MG N009768 001
HYDROXYPROGESTERONE CAPROATE
SOLUTION;INTRAMUSCULAR
MAKENA
+ KV PHARM 1250MG/5ML (250MG/ML) N021945 001 Feb 03, 2011
HYDROXYPROPYL CELLULOSE
INSERT;OPHTHALMIC
LACRISERT
+ ATON 5MG N018771 001
HYDROXYUREA
CAPSULE;ORAL
HYDREA
AB + BRISTOL MYERS SQUIBB 500MG N016295 001
HYDROXYUREA
AB BARR 500MG A075143 001 Oct 16, 1998
AB PAR PHARM 500MG A075340 001 Feb 24, 1999
DROXIA
BRISTOL MYERS SQUIBB 200MG N016295 002 Feb 25, 1998
300MG N016295 003 Feb 25, 1998
400MG N016295 004 Feb 25, 1998
HYDROXYZINE HYDROCHLORIDE
INJECTABLE;INJECTION
HYDROXYZINE HYDROCHLORIDE
AP + FRESENIUS KABI USA 25MG/ML A087329 001
AP + 50MG/ML A087329 002
AP LUITPOLD 25MG/ML A087408 001
AP 50MG/ML A087408 002
SYRUP;ORAL
HYDROXYZINE HYDROCHLORIDE
AA + HI TECH PHARMA 10MG/5ML A040010 001 Oct 28, 1994
AA SILARX PHARMS INC 10MG/5ML A201674 001 Aug 21, 2013
AA + VINTAGE PHARMS 10MG/5ML A040391 001 Apr 10, 2002
AA + WOCKHARDT 10MG/5ML A087294 001 Apr 12, 1982
TABLET;ORAL
HYDROXYZINE HYDROCHLORIDE
AB AMNEAL PHARM 10MG A040808 001 Sep 24, 2008
AB 25MG A040808 002 Sep 24, 2008
AB 50MG A040808 003 Sep 24, 2008
AB CARACO 10MG A040899 001 Jun 10, 2008
AB 25MG A040899 002 Jun 10, 2008
AB 50MG A040899 003 Jun 10, 2008
AB HERITAGE PHARMS INC 10MG A040804 001 Jun 30, 2008
AB 25MG A040804 002 Jun 30, 2008
AB 50MG A040804 003 Jun 30, 2008
AB HETERO LABS LTD III 10MG A040805 001 May 29, 2008
AB 25MG A040805 002 May 29, 2008
AB 50MG A040805 003 May 29, 2008
AB INVAGEN PHARMS 10MG A040812 001 Mar 12, 2008
AB 25MG A040812 002 Mar 12, 2008
AB 50MG A040812 003 Mar 12, 2008
AB KVK TECH 10MG A040786 001 Mar 20, 2007
AB 25MG A040787 001 Mar 20, 2007
AB 50MG A040788 001 Mar 20, 2007
AB MUTUAL PHARM 10MG A089381 001 May 19, 1986
AB 25MG A089382 001 May 19, 1986
AB 50MG A089383 001 May 19, 1986
AB MYLAN 10MG A091176 001 Jun 07, 2010
AB 25MG A091176 002 Jun 07, 2010
AB 50MG A091176 003 Jun 07, 2010
AB NORTHSTAR HLTHCARE 10MG A040841 001 Mar 31, 2008
AB 25MG A040842 001 Mar 31, 2008
AB 50MG A040840 001 Mar 31, 2008
AB + PLIVA 10MG A088617 001 Jan 10, 1986
AB + 25MG A088618 001 Jan 10, 1986
AB + 50MG A088619 001 Jan 10, 1986
AB VINTAGE PHARMS 10MG A040579 001 May 27, 2005
AB 25MG A040574 001 May 27, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
HYDROXYZINE HYDROCHLORIDE
TABLET;ORAL
HYDROXYZINE HYDROCHLORIDE
AB
AB WATSON LABS
AB
AB
AB
AB
AB
HYDROXYZINE PAMOATE
CAPSULE;ORAL
HYDROXYZINE PAMOATE
AB BARR
AB
AB EMCURE PHARMS USA
AB
AB SANDOZ
AB
AB WATSON LABS
AB
AB
VISTARIL
AB PFIZER
AB +
HYDROXYZINE PAMOATE
BARR
IBANDRONATE SODIUM
INJECTABLE;INTRAVENOUS
BONIVA
+ ROCHE
TABLET;ORAL
BONIVA
AB + HOFFMANN LA ROCHE
IBANDRONATE SODIUM
AB APOTEX INC
AB DR REDDYS LABS LTD
AB MUTUAL PHARM CO INC
AB MYLAN PHARMS INC
AB ORCHID HLTHCARE
AB WATSON LABS INC
IBRUTINIB
CAPSULE;ORAL
IMBRUVICA
+ PHARMACYCLICS INC
IBUPROFEN
SOLUTION;INTRAVENOUS
CALDOLOR
+ CUMBERLAND PHARMS
SUSPENSION;ORAL
IBUPROFEN
AB + ACTAVIS MID ATLANTIC
AB PERRIGO R AND D
TABLET;ORAL
IBU-TAB
AB ALRA
AB
IBUPROFEN
AB AMNEAL PHARMS NY
AB
AB
AB
AB
AB
AB CONTRACT PHARMACAL
AB
AB
AB DR REDDYS LA
AB
AB +
50MG
10MG
10MG
25MG
25MG
50MG
50MG
EQ 25MG HCL
EQ 50MG HCL
25MG
50MG
EQ 25MG HCL
EQ 50MG HCL
EQ 25MG HCL
EQ 25MG HCL
EQ 50MG HCL
EQ 25MG HCL
EQ 50MG HCL
EQ 100MG HCL
EQ 3MG BASE/3ML
EQ 150MG BASE
EQ 150MG BASE
EQ 150MG BASE
EQ 150MG BASE
EQ 150MG BASE
EQ 150MG BASE
EQ 150MG BASE
140MG
800MG/8ML (100MG/ML)
100MG/5ML
100MG/5ML
400MG
600MG
400MG
400MG
600MG
600MG
800MG
800MG
400MG
600MG
800MG
400MG
600MG
800MG
3-188( of 362)
A040580 001 May 27, 2005
A081149 001 Mar 18, 1994
A088348 001 Sep 15, 1983
A081150 001 Mar 18, 1994
A088349 001 Sep 15, 1983
A081151 001 Mar 18, 1994
A088350 001 Sep 15, 1983
A088496 001 Jun 15, 1984
A088487 001 Jun 15, 1984
A201507 001 Jun 03, 2013
A201507 002 Jun 03, 2013
A087479 001
A086183 001
A040156 001 Jul 15, 1996
A081165 001 Jul 31, 1991
A040156 002 Jul 15, 1996
N011459 002
N011459 004
A088488 001 Jun 15, 1984
N021858 001 Jan 06, 2006
N021455 002 Mar 24, 2005
A078948 001 Mar 19, 2012
A078997 001 Apr 30, 2012
A078996 001 Aug 15, 2012
A078995 001 Mar 19, 2012
A078998 001 Mar 19, 2012
A079003 001 Mar 20, 2012
N205552 001 Nov 13, 2013
N022348 002 Jun 11, 2009
A074978 001 Mar 25, 1998
A076925 001 Sep 23, 2004
A071058 001 Aug 11, 1988
A071059 001 Aug 11, 1988
A071334 001 Nov 25, 1986
A078558 001 Jun 18, 2007
A071335 001 Nov 25, 1986
A078558 002 Jun 18, 2007
A071935 001 Oct 13, 1987
A078558 003 Jun 18, 2007
A071267 001 Oct 15, 1986
A071268 001 Oct 15, 1986
A072300 001 Jul 01, 1988
A075682 001 Nov 14, 2001
A075682 002 Nov 14, 2001
A075682 003 Nov 14, 2001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
IBUPROFEN
TABLET;ORAL
IBUPROFEN
AB DR REDDYS LABS INC
AB
AB
AB MARKSANS PHARMA
AB
AB
AB PERRIGO R AND D
AB
AB
AB SHASUN USA
AB
AB
AB VINTAGE PHARMS
AB
AB
AB
AB
AB WATSON LABS
AB
IBUPROFEN LYSINE
INJECTABLE;INTRAVENOUS
NEOPROFEN
+ RECORDATI RARE
IBUPROFEN; OXYCODONE HYDROCHLORIDE
TABLET;ORAL
OXYCODONE HYDROCHLORIDE AND IBUPROFEN
AB ACTAVIS ELIZABETH
AB + BARR LABS INC
AB WATSON LABS
IBUTILIDE FUMARATE
INJECTABLE;INJECTION
CORVERT
AP + PHARMACIA AND UPJOHN
IBUTILIDE FUMARATE
AP LUITPOLD
AP MYLAN INSTITUTIONAL
AP
ICATIBANT ACETATE
INJECTABLE;SUBCUTANEOUS
FIRAZYR
+ SHIRE ORPHAN THERAP
ICODEXTRIN
SOLUTION;INTRAPERITONEAL
EXTRANEAL
+ BAXTER HLTHCARE
ICOSAPENT ETHYL
CAPSULE;ORAL
VASCEPA
+ AMARIN PHARMS
IDARUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
IDAMYCIN PFS
AP + PHARMACIA AND UPJOHN
IDARUBICIN HYDROCHLORIDE
AP BEDFORD LABS
AP
AP FRESENIUS KABI USA
AP ONCO THERAPIES LTD
AP SANDOZ
IDARUBICIN HYDROCHLORIDE PFS
400MG
600MG
800MG
400MG
600MG
800MG
400MG
600MG
800MG
400MG
600MG
800MG
300MG
400MG
400MG
600MG
800MG
400MG
600MG
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
400MG;5MG
400MG;5MG
400MG;5MG
0.1MG/ML
0.1MG/ML
0.1MG/ML
0.1MG/ML
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
7.5GM/100ML
1GM
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
3-189( of 362)
A076112 001 Oct 31, 2001
A076112 002 Oct 31, 2001
A076112 003 Oct 31, 2001
A090796 001 Dec 21, 2010
A090796 002 Dec 21, 2010
A090796 003 Dec 21, 2010
A077114 001 Jul 18, 2005
A077114 002 Jul 18, 2005
A077114 003 Jul 18, 2005
A078329 001 Feb 05, 2009
A078329 002 Feb 05, 2009
A078329 003 Feb 05, 2009
A071230 001 Oct 22, 1986
A071231 001 Oct 22, 1986
A071644 001 Feb 01, 1988
A071232 001 Oct 22, 1986
A072004 001 Nov 18, 1987
A070436 001 Aug 21, 1985
A070437 001 Aug 21, 1985
N021903 001 Apr 13, 2006
A078769 001 Jan 04, 2008
A078316 001 Nov 29, 2007
A078394 001 Nov 26, 2007
N020491 001 Dec 28, 1995
A090240 001 Jan 11, 2010
A090643 001 Jan 11, 2010
A090924 001 Jan 11, 2010
N022150 001 Aug 25, 2011
N021321 001 Dec 20, 2002
N202057 001 Jul 26, 2012
N050734 001 Feb 17, 1997
A065275 001 Dec 14, 2006
A065288 001 May 15, 2007
A065440 001 Aug 04, 2009
A200144 001 Oct 11, 2012
A091293 001 Mar 29, 2011
AP TEVA PHARMS USA 1MG/ML A065036 001 May 01, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-190( of 362)
IDOXURIDINE
SOLUTION/DROPS;OPHTHALMIC
DENDRID
AT + ALCON 0.1% N014169 001
HERPLEX
AT + ALLERGAN 0.1% N013935 002
IFOSFAMIDE
INJECTABLE;INJECTION
IFEX
AP BAXTER HLTHCARE 1GM/VIAL N019763 001 Dec 30, 1988
AP 3GM/VIAL N019763 002 Dec 30, 1988
IFOSFAMIDE
AP BEDFORD LABS 1GM/20ML(50MG/ML) A076619 001 Jun 29, 2011
AP 3GM/60ML(50MG/ML) A076619 002 Jun 29, 2011
AP + FRESENIUS KABI USA 1GM/VIAL A076078 001 May 28, 2002
AP 1GM/20ML (50MG/ML) A090181 001 Sep 22, 2009
AP + 3GM/VIAL A076078 002 May 28, 2002
AP 3GM/60ML (50MG/ML) A090181 002 Sep 22, 2009
AP ONCO THERAPIES LTD 1GM/20ML (50MG/ML) A201689 001 Nov 26, 2012
AP 3GM/60ML (50MG/ML) A201689 002 Nov 26, 2012
AP + TEVA PHARMS USA 1GM/20ML (50MG/ML) A076657 001 Apr 04, 2007
AP + 3GM/60ML (50MG/ML) A076657 002 Apr 04, 2007
IFOSFAMIDE; MESNA
INJECTABLE;INTRAVENOUS
IFOSFAMIDE/MESNA KIT
+ TEVA PHARMS USA 1GM/20ML;1GM/10ML (50MG/ML;100MG/ML) A075874 001 Feb 26, 2002
+ 3GM/60ML;1GM/10ML (50MG/ML;100MG/ML) A075874 002 Feb 26, 2002
ILOPERIDONE
TABLET;ORAL
FANAPT
+ NOVARTIS 1MG N022192 001 May 06, 2009
2MG N022192 002 May 06, 2009
4MG N022192 003 May 06, 2009
6MG N022192 004 May 06, 2009
8MG N022192 005 May 06, 2009
10MG N022192 006 May 06, 2009
12MG N022192 007 May 06, 2009
ILOPROST
SOLUTION;INHALATION
VENTAVIS
+ ACTELION PHARMS LTD 10MCG/ML (10MCG/ML) N021779 002 Dec 08, 2005
+ 20MCG/ML (20MCG/ML) N021779 003 Aug 07, 2009
IMATINIB MESYLATE
TABLET;ORAL
GLEEVEC
NOVARTIS EQ 100MG BASE N021588 001 Apr 18, 2003
+ EQ 400MG BASE N021588 002 Apr 18, 2003
IMIGLUCERASE
INJECTABLE;INJECTION
CEREZYME
GENZYME 200 UNITS/VIAL N020367 001 May 23, 1994
+ 400 UNITS/VIAL N020367 002 Sep 22, 1999
IMIPRAMINE HYDROCHLORIDE
TABLET;ORAL
IMIPRAMINE HYDROCHLORIDE
AB EXCELLIUM 10MG A040903 001 Oct 24, 2012
AB 25MG A040903 002 Oct 24, 2012
AB 50MG A040903 003 Oct 24, 2012
AB LUPIN LTD 10MG A090443 001 Mar 11, 2010
AB 25MG A090442 001 Mar 11, 2010
AB 50MG A090441 001 Mar 11, 2010
AB MUTUAL PHARM 10MG A081048 001 Jun 05, 1990
AB 25MG A081049 001 Jun 05, 1990
AB 50MG A081050 001 Jun 05, 1990
AB PAR PHARM 10MG A088292 001 Oct 21, 1983
AB 10MG A089422 001 Jul 14, 1987
AB 25MG A088262 001 Oct 21, 1983
AB 50MG A088276 001 Oct 21, 1983
AB SANDOZ 10MG A084936 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
IMIPRAMINE HYDROCHLORIDE
TABLET;ORAL
IMIPRAMINE HYDROCHLORIDE
AB 25MG
AB 50MG
TOFRANIL
AB MALLINCKRODT INC 10MG
AB 25MG
AB + 50MG
IMIPRAMINE PAMOATE
CAPSULE;ORAL
IMIPRAMINE PAMOATE
AB LUPIN LTD EQ 75MG HCL
AB EQ 100MG HCL
AB EQ 125MG HCL
AB EQ 150MG HCL
AB MYLAN PHARMS INC EQ 75MG HCL
AB EQ 100MG HCL
AB EQ 125MG HCL
AB EQ 150MG HCL
AB ROXANE EQ 75MG HCL
AB EQ 100MG HCL
AB EQ 125MG HCL
AB EQ 150MG HCL
TOFRANIL-PM
AB + MALLINCKRODT INC EQ 75MG HCL
AB EQ 100MG HCL
AB EQ 125MG HCL
AB EQ 150MG HCL
IMIQUIMOD
CREAM;TOPICAL
ALDARA
AB + MEDICIS 5%
IMIQUIMOD
AB APOTEX INC 5%
AB FOUGERA PHARMS 5%
AB GLENMARK GENERICS 5%
AB PERRIGO ISRAEL 5%
AB TARO 5%
AB TEVA PHARMS USA 5%
AB TOLMAR 5%
ZYCLARA
+ MEDICIS 2.5%
+ 3.75%
INAMRINONE LACTATE
INJECTABLE;INJECTION
AMRINONE LACTATE
+ BEDFORD EQ 5MG BASE/ML
INDACATEROL MALEATE
POWDER;INHALATION
ARCAPTA NEOHALER
+ NOVARTIS EQ 75MCG BASE
INDAPAMIDE
TABLET;ORAL
INDAPAMIDE
AB ACTAVIS ELIZABETH 1.25MG
AB 2.5MG
AB IVAX SUB TEVA PHARMS 1.25MG
AB 2.5MG
AB MYLAN 1.25MG
AB + 2.5MG
AB MYLAN PHARMS INC 1.25MG
AB 2.5MG
AB WATSON LABS 1.25MG
AB 2.5MG
3-191( of 362)
A083745 001
A084937 001
A087844 001 May 22, 1984
A087845 001 May 22, 1984
A087846 001 May 22, 1984
A090444 001 Apr 16, 2010
A090444 002 Apr 16, 2010
A090444 003 Apr 16, 2010
A090444 004 Apr 16, 2010
A202338 001 Jun 28, 2013
A202338 002 Jun 28, 2013
A202338 003 Jun 28, 2013
A202338 004 Jun 28, 2013
A091099 001 Apr 16, 2010
A091099 002 Apr 16, 2010
A091099 003 Apr 16, 2010
A091099 004 Apr 16, 2010
N017090 001
N017090 004
N017090 003
N017090 002
N020723 001 Feb 27, 1997
A091308 001 Apr 06, 2012
A078548 001 Feb 25, 2010
A201994 001 Mar 06, 2012
A078837 001 Sep 07, 2010
A200173 001 Apr 15, 2011
A200481 001 Apr 18, 2011
A091044 001 Feb 28, 2011
N022483 002 Jul 15, 2011
N022483 001 Mar 25, 2010
A075513 001 May 09, 2000
N022383 001 Jul 01, 2011
A074722 001 Jun 17, 1996
A074722 002 Jun 17, 1996
A074299 002 Apr 29, 1996
A074299 001 Jul 27, 1995
A074461 002 Mar 26, 1997
A074461 001 Mar 27, 1996
A075105 001 Jul 23, 1998
A075105 002 Jul 23, 1998
A074585 001 Sep 26, 1996
A074585 002 Sep 26, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-192( of 362)
INDINAVIR SULFATE
CAPSULE;ORAL
CRIXIVAN
MERCK SHARP DOHME EQ 200MG BASE N020685 003 Mar 13, 1996
+ EQ 400MG BASE N020685 001 Mar 13, 1996
INDIUM IN-111 CHLORIDE
INJECTABLE;INJECTION
INDICLOR
+ GE HEALTHCARE 2mCi/0.2ML N019862 001 Dec 29, 1992
INDIUM IN 111 CHLORIDE
+ MALLINCKRODT 5mCi/0.5ML N019841 001 Sep 27, 1994
INDIUM IN-111 OXYQUINOLINE
INJECTABLE;INJECTION
INDIUM IN-111 OXYQUINOLINE
+ GE HEALTHCARE 1mCi/ML N019044 001 Dec 24, 1985
INDIUM IN-111 PENTETATE DISODIUM
INJECTABLE;INTRATHECAL
MPI INDIUM DTPA IN 111
+ GE HEALTHCARE 1mCi/ML N017707 001 Feb 18, 1982
INDIUM IN-111 PENTETREOTIDE KIT
INJECTABLE;INJECTION
OCTREOSCAN
+ MALLINCKRODT 3mCi/ML N020314 001 Jun 02, 1994
INDOCYANINE GREEN
INJECTABLE;INJECTION
IC-GREEN
AP + AKORN 25MG/VIAL N011525 001
INDOCYANINE GREEN
AP PULSION MEDCL 25MG/VIAL A040811 001 Nov 21, 2007
INDOMETHACIN
CAPSULE;ORAL
INDOMETHACIN
AB CARACO 25MG A091401 001 Mar 28, 2013
AB 50MG A091401 002 Mar 28, 2013
AB GLENMARK GENERICS 25MG A091276 001 Dec 22, 2010
AB 50MG A091276 002 Dec 22, 2010
AB HERITAGE PHARMS INC 25MG N018851 001 May 18, 1984
AB 50MG N018851 002 May 18, 1984
AB HETERO LABS LTD III 25MG A091240 001 Apr 12, 2011
AB 50MG A091240 002 Apr 12, 2011
AB IVAX SUB TEVA PHARMS 25MG A070719 001 Feb 12, 1986
AB 50MG A070756 001 Feb 12, 1986
AB MYLAN 25MG N018858 001 Apr 20, 1984
AB + 50MG A070624 001 Sep 04, 1985
AB SANDOZ 25MG A070673 001 Apr 29, 1987
AB 50MG A070674 001 Apr 29, 1987
AB ZYDUS PHARMS USA INC 25MG A090403 001 Nov 15, 2010
AB 50MG A090403 002 Nov 15, 2010
CAPSULE, EXTENDED RELEASE;ORAL
INDOMETHACIN
AB AMNEAL PHARMS 75MG A091549 001 Dec 01, 2010
AB AVANTHI INC 75MG A079175 001 Mar 06, 2009
AB HETERO LABS LTD III 75MG A201807 001 Sep 28, 2012
AB PADDOCK LLC 75MG A200529 001 Nov 30, 2010
AB + SANDOZ 75MG A074464 001 May 28, 1998
AB WATSON LABS INC 75MG A202572 001 Dec 09, 2013
INJECTABLE;INJECTION
INDOMETHACIN
+ FRESENIUS KABI USA EQ 1MG BASE/VIAL N022536 001 Mar 17, 2010
SUPPOSITORY;RECTAL
INDOMETHACIN
+ G AND W LABS 50MG A073314 001 Aug 31, 1992
SUSPENSION;ORAL
INDOCIN
+ IROKO PHARMS 25MG/5ML N018332 001 Oct 10, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
INDOMETHACIN SODIUM
INJECTABLE;INJECTION
INDOCIN
AP + RECORDATI RARE
INDOMETHACIN SODIUM
AP BEDFORD
INGENOL MEBUTATE
GEL;TOPICAL
PICATO
LEO PHARMA AS
+
PRESCRIPTION DRUG PRODUCT LIST
EQ 1MG BASE/VIAL
EQ 1MG BASE/VIAL
0.015%
0.05%
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
INJECTABLE;SUBCUTANEOUS
NOVOLOG MIX 70/30
+ NOVO NORDISK INC
NOVOLOG MIX 70/30 FLEXPEN
+ NOVO NORDISK INC
INSULIN ASPART RECOMBINANT
INJECTABLE;SUBCUTANEOUS
NOVOLOG
+ NOVO NORDISK INC
NOVOLOG FLEXPEN
+ NOVO NORDISK INC
NOVOLOG PENFILL
+ NOVO NORDISK INC
INSULIN DETEMIR RECOMBINANT
INJECTABLE;SUBCUTANEOUS
LEVEMIR
+ NOVO NORDISK INC
LEVEMIR FLEXPEN
+ NOVO NORDISK INC
INSULIN GLARGINE RECOMBINANT
INJECTABLE;INJECTION
LANTUS
+ SANOFI AVENTIS US
LANTUS SOLOSTAR
+ SANOFI AVENTIS US
INSULIN GLULISINE RECOMBINANT
INJECTABLE;IV (INFUSION)-SC
APIDRA
+ SANOFI AVENTIS US
+
INJECTABLE;SUBCUTANEOUS
APIDRA SOLOSTAR
SANOFI AVENTIS US
700 UNITS/10ML;300 UNITS/10ML (70
UNITS/ML; 30 UNITS/ML)
210 UNITS/3ML;90 UNITS/3ML (70
UNITS/ML; 30 UNITS/ML)
1000 UNITS/10ML (100 UNITS/ML)
300 UNITS/3ML (100 UNITS/ML)
300 UNITS/3ML (100 UNITS/ML)
1000 UNITS/10ML (100 UNITS/ML)
300 UNITS/3ML (100 UNITS/ML)
100 UNITS/ML
300 UNITS/3ML (100 UNITS/ML)
1000 UNITS/10ML (100 UNITS/ML)
300 UNITS/3ML (100 UNITS/ML)
300 UNITS/3ML
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT
INJECTABLE;INJECTION
HUMALOG MIX 50/50
+ LILLY
HUMALOG MIX 50/50 KWIKPEN
+ LILLY
HUMALOG MIX 75/25
+ LILLY
HUMALOG MIX 75/25 KWIKPEN
+ LILLY
INSULIN LISPRO RECOMBINANT
INJECTABLE;INJECTION
HUMALOG
+ LILLY
HUMALOG KWIKPEN
+ LILLY
50 UNITS/ML;50 UNITS/ML
50 UNITS/ML;50 UNITS/ML
75 UNITS/ML;25 UNITS/ML
75 UNITS/ML;25 UNITS/ML
100 UNITS/ML
100 UNITS/ML
3-193( of 362)
N018878 001 Jan 30, 1985
A078713 001 Jul 16, 2008
N202833 001
N202833 002
N021172 001
N021172 004
N020986 001
N020986 003
N020986 002
N021536 001
N021536 002
N021081 001
N021081 002
N021629 001
N021629 002
N021629 003
N021018 001
N021018 002
N021017 001
N021017 002
N020563 001
N020563 003
Jan 23, 2012
Jan 23, 2012
Nov 01, 2001
May 03, 2002
Jun 07, 2000
Jan 19, 2001
Jun 07, 2000
Jun 16, 2005
Jun 16, 2005
Apr 20, 2000
Apr 27, 2007
Apr 16, 2004
Dec 20, 2005
Feb 24, 2009
Dec 22, 1999
Sep 06, 2007
Dec 22, 1999
Sep 06, 2007
Jun 14, 1996
Sep 06, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-194( of 362)
INSULIN RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN R
+ LILLY 500 UNITS/ML N018780 004 Mar 31, 1994
IOBENGUANE SULFATE I-123
SOLUTION;INTRAVENOUS
ADREVIEW
+ GE HEALTHCARE 10mCi/5ML (2mCi/ML) N022290 001 Sep 19, 2008
IODIPAMIDE MEGLUMINE
INJECTABLE;INJECTION
CHOLOGRAFIN MEGLUMINE
+ BRACCO 52% N009321 003
IODIXANOL
INJECTABLE;INJECTION
VISIPAQUE 270
+ GE HEALTHCARE 55% N020351 001 Mar 22, 1996
55% N020808 001 Aug 29, 1997
VISIPAQUE 320
+ GE HEALTHCARE 65.2% N020351 002 Mar 22, 1996
65.2% N020808 002 Aug 29, 1997
IOFLUPANE I-123
SOLUTION;INTRAVENOUS
DATSCAN
+ GE HLTHCARE INC 5mCi/2.5ML (2mCi/ML) N022454 001 Jan 14, 2011
IOHEXOL
INJECTABLE;INJECTION
OMNIPAQUE 140
+ GE HEALTHCARE 30.2% N018956 005 Nov 30, 1988
SOLUTION;INJECTION, ORAL
OMNIPAQUE 350
+ GE HEALTHCARE 75.5% N018956 004 Dec 26, 1985
75.5% N020608 003 Oct 24, 1995
SOLUTION;INJECTION, ORAL, RECTAL
OMNIPAQUE 180
+ GE HEALTHCARE 38.8% N018956 001 Dec 26, 1985
OMNIPAQUE 240
+ GE HEALTHCARE 51.8% N018956 002 Dec 26, 1985
51.8% N020608 001 Oct 24, 1995
OMNIPAQUE 300
+ GE HEALTHCARE 64.7% N018956 003 Dec 26, 1985
64.7% N020608 002 Oct 24, 1995
IOPAMIDOL
INJECTABLE;INJECTION
IOPAMIDOL-250
AP FRESENIUS KABI USA 51% A074679 001 Apr 02, 1997
IOPAMIDOL-300
AP FRESENIUS KABI USA 61% A074679 002 Apr 02, 1997
IOPAMIDOL-370
AP FRESENIUS KABI USA 76% A074679 003 Apr 02, 1997
ISOVUE-200
AP + BRACCO 41% N018735 006 Jul 07, 1987
ISOVUE-250
AP + BRACCO 51% N018735 007 Jul 06, 1992
AP + 51% N020327 002 Oct 12, 1994
ISOVUE-300
AP + BRACCO 61% N018735 002 Dec 31, 1985
AP + 61% N020327 003 Oct 12, 1994
ISOVUE-370
AP + BRACCO 76% N018735 003 Dec 31, 1985
AP + 76% N020327 004 Oct 12, 1994
SCANLUX-300
AP SANOCHEMIA CORP USA 61% A090394 001 Jun 18, 2010
SCANLUX-370
AP SANOCHEMIA CORP USA 76% A090394 002 Jun 18, 2010
ISOVUE-M 200
+ BRACCO 41% N018735 001 Dec 31, 1985
ISOVUE-M 300
+ BRACCO 61% N018735 004 Dec 31, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
IOPROMIDE
INJECTABLE;INJECTION
ULTRAVIST (PHARMACY BULK)
+ BAYER HLTHCARE
+
+
ULTRAVIST 150
+ BAYER HLTHCARE
ULTRAVIST 240
+ BAYER HLTHCARE
ULTRAVIST 300
+ BAYER HLTHCARE
49.9%
62.3%
76.9%
31.2%
49.9%
62.3%
ULTRAVIST 300 IN PLASTIC CONTAINER
+ BAYER HLTHCARE
ULTRAVIST 370
+ BAYER HLTHCARE
IOTHALAMATE MEGLUMINE
INJECTABLE;INJECTION
CONRAY
+ MALLINCKRODT
CONRAY 30
+ MALLINCKRODT
CONRAY 43
+ MALLINCKRODT
SOLUTION;INTRAVESICAL
CYSTO-CONRAY II
MALLINCKRODT
IOTHALAMATE SODIUM I-125
INJECTABLE;INJECTION
GLOFIL-125
ISOTEX
IOVERSOL
INJECTABLE;INJECTION
OPTIRAY 240
+ MALLINCKRODT
OPTIRAY 300
+ MALLINCKRODT
+
OPTIRAY 320
+ MALLINCKRODT
OPTIRAY 350
+ MALLINCKRODT
+
62.3%
76.9%
60%
30%
43%
17.2%
250-300uCi/ML
51%
64%
64%
68%
74%
74%
IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM
INJECTABLE;INJECTION
HEXABRIX
+ GUERBET 39.3%;19.6%
IOXILAN
INJECTABLE;INJECTION
OXILAN-300
GUERBET 62%
OXILAN-350
GUERBET 73%
IPRATROPIUM BROMIDE
AEROSOL, METERED;INHALATION
ATROVENT HFA
+ BOEHRINGER INGELHEIM 0.021MG/INH
SOLUTION;INHALATION
IPRATROPIUM BROMIDE
3-195( of 362)
N021425 003 Mar 12, 2004
N021425 001 Sep 20, 2002
N021425 002 Sep 20, 2002
N020220 004 May 10, 1995
N020220 003 May 10, 1995
N020220 002 May 10, 1995
N020220 005 Nov 18, 2008
N020220 001 May 10, 1995
N013295 001
N016983 001
N013295 002
N017057 002
N017279 001
N019710 002 Dec 30, 1988
N019710 004 Jan 22, 1992
N020923 004 May 13, 1999
N019710 001 Dec 30, 1988
N019710 005 Jan 22, 1992
N020923 003 May 28, 1998
N018905 002 Jul 26, 1985
N020316 001 Dec 21, 1995
N020316 002 Dec 21, 1995
N021527 001 Nov 27, 2004
AN BAUSCH AND LOMB
AN + DEY
AN LANDELA PHARM
AN NEPHRON
AN RITEDOSE CORP
AN WATSON LABS
SPRAY, METERED;NASAL
ATROVENT
AB + BOEHRINGER INGELHEIM
AB +
0.02%
0.02%
0.02%
0.02%
0.02%
0.02%
0.021MG/SPRAY
0.042MG/SPRAY
A075835 001 Oct 15, 2001
A074755 001 Jan 10, 1997
A077072 001 Jul 19, 2005
A075562 001 Sep 27, 2001
A075693 001 Jan 26, 2001
A076291 001 May 09, 2005
N020393 001 Oct 20, 1995
N020394 001 Oct 20, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
IPRATROPIUM BROMIDE
SPRAY, METERED;NASAL
IPRATROPIUM BROMIDE
AB BAUSCH AND LOMB
AB
AB DEY
AB
AB ROXANE
AB
IRBESARTAN
TABLET;ORAL
AVAPRO
AB SANOFI AVENTIS US
AB
AB +
IRBESARTAN
AB ALEMBIC PHARMS LTD
AB
AB
AB APOTEX INC
AB
AB
AB AUROBINDO PHARMA LTD
AB
AB
AB CIPLA LTD
AB
AB
AB DR REDDYS LABS LTD
AB
AB
AB HETERO LABS LTD V
AB
AB
AB LUPIN LTD
AB
AB
AB MACLEODS PHARMS LTD
AB
AB
AB MYLAN PHARMS INC
AB
AB
AB PRINSTON INC
AB
AB
AB ROXANE
AB
AB
AB SANDOZ
AB
AB
AB TEVA PHARMS
AB
AB
AB WATSON LABS INC
AB
AB
AB ZYDUS PHARMS USA INC
AB
AB
IRINOTECAN HYDROCHLORIDE
INJECTABLE;INJECTION
CAMPTOSAR
AP + PFIZER INC
AP +
IRINOTECAN HYDROCHLORIDE
AP ACCORD HLTHCARE
AP
AP ACTAVIS TOTOWA
AP
0.021MG/SPRAY
0.042MG/SPRAY
0.021MG/SPRAY
0.042MG/SPRAY
0.021MG/SPRAY
0.042MG/SPRAY
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
75MG
150MG
300MG
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
3-196( of 362)
A076025 001 Mar 31, 2003
A076103 001 Mar 31, 2003
A075552 001 Mar 31, 2003
A075553 001 Mar 31, 2003
A076664 001 Nov 05, 2003
A076598 001 Nov 05, 2003
N020757 001 Sep 30, 1997
N020757 002 Sep 30, 1997
N020757 003 Sep 30, 1997
A091236 001 Oct 15, 2012
A091236 002 Oct 15, 2012
A091236 003 Oct 15, 2012
A200832 001 Oct 15, 2012
A200832 002 Oct 15, 2012
A200832 003 Oct 15, 2012
A203081 001 Sep 27, 2012
A203081 002 Sep 27, 2012
A203081 003 Sep 27, 2012
A077205 001 Nov 14, 2012
A077205 002 Nov 14, 2012
A077205 003 Nov 14, 2012
A203161 001 Sep 27, 2012
A203161 002 Sep 27, 2012
A203161 003 Sep 27, 2012
A202910 001 Sep 27, 2012
A202910 002 Sep 27, 2012
A202910 003 Sep 27, 2012
A201531 001 Oct 15, 2012
A201531 002 Oct 15, 2012
A201531 003 Oct 15, 2012
A202254 001 Oct 03, 2012
A202254 002 Oct 03, 2012
A202254 003 Oct 03, 2012
A200461 001 Sep 27, 2012
A200461 002 Sep 27, 2012
A200461 003 Sep 27, 2012
A203071 001 Sep 27, 2012
A203071 002 Sep 27, 2012
A203071 003 Sep 27, 2012
A090201 001 Oct 15, 2012
A090201 002 Oct 15, 2012
A090201 003 Oct 15, 2012
A077466 001 Sep 27, 2012
A077466 002 Sep 27, 2012
A077466 003 Sep 27, 2012
A077159 001 Mar 30, 2012
A077159 002 Mar 30, 2012
A077159 003 Mar 30, 2012
A090720 001 Oct 12, 2012
A090720 002 Oct 12, 2012
A090720 003 Oct 12, 2012
A079213 001 Sep 27, 2012
A079213 002 Sep 27, 2012
A079213 003 Sep 27, 2012
N020571 001 Jun 14, 1996
N020571 002 Jun 14, 1996
A079068 001 Nov 21, 2008
A079068 002 Nov 21, 2008
A078589 001 Feb 27, 2008
A078589 002 Feb 27, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-197( of 362)
IRINOTECAN HYDROCHLORIDE
INJECTABLE;INJECTION
IRINOTECAN HYDROCHLORIDE
AP AKORN 40MG/2ML (20MG/ML) A090726 001 Sep 16, 2009
AP 100MG/5ML (20MG/ML) A090726 002 Sep 16, 2009
AP BEDFORD LABS 40MG/2ML (20MG/ML) A078753 001 Dec 24, 2008
AP 100MG/5ML (20MG/ML) A078753 002 Dec 24, 2008
AP CIPLA LTD 40MG/2ML (20MG/ML) A077219 001 Feb 20, 2008
AP 100MG/5ML (20MG/ML) A077219 002 Feb 20, 2008
AP DR REDDYS LABS LTD 40MG/2ML (20MG/ML) A078953 001 Apr 15, 2010
AP 100MG/5ML (20MG/ML) A078953 002 Apr 15, 2010
AP EBEWE PHARMA 40MG/2ML (20MG/ML) A090137 001 Nov 12, 2009
AP 100MG/5ML (20MG/ML) A090137 002 Nov 12, 2009
AP EMCURE PHARMS LTD 40MG/2ML (20MG/ML) A200771 001 Feb 14, 2012
AP 100MG/5ML (20MG/ML) A200771 002 Feb 14, 2012
AP FRESENIUS KABI ONCOL 40MG/2ML (20MG/ML) A078188 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML) A078188 002 Feb 27, 2008
AP FRESENIUS KABI USA 40MG/2ML (20MG/ML) A077776 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML) A077776 002 Feb 27, 2008
AP HIKMA FARMACEUTICA 40MG/2ML (20MG/ML) A091032 001 Dec 20, 2010
AP 100MG/5ML (20MG/ML) A091032 002 Dec 20, 2010
AP HISUN PHARM HANGZHOU 40MG/2ML (20MG/ML) A090016 001 Jan 28, 2009
AP 100MG/5ML (20MG/ML) A090016 002 Jan 28, 2009
AP HOSPIRA 40MG/2ML (20MG/ML) A077915 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML) A077915 002 Feb 27, 2008
AP + 500MG/25ML (20MG/ML) A078796 001 Feb 27, 2008
AP JIANGSU HENGRUI MED 40MG/2ML (20MG/ML) A090675 002 Dec 16, 2011
AP 100MG/5ML (20MG/ML) A090675 001 Dec 16, 2011
AP MYLAN INSTITUTIONAL 40MG/2ML (20MG/ML) A090393 002 May 13, 2011
AP 100MG/5ML (20MG/ML) A090393 003 May 13, 2011
AP PLIVA LACHEMA 40MG/2ML (20MG/ML) A078122 001 Oct 31, 2008
AP 100MG/5ML (20MG/ML) A078122 002 Oct 31, 2008
AP SUN PHARMA GLOBAL 40MG/2ML (20MG/ML) A078805 001 Apr 21, 2008
AP 100MG/5ML (20MG/ML) A078805 002 Apr 21, 2008
AP TEVA PHARMS USA 40MG/2ML (20MG/ML) A090101 002 Feb 27, 2008
AP 100MG/5ML (20MG/ML) A090101 003 Feb 27, 2008
AP 500MG/25ML (20MG/ML) A090101 001 Nov 26, 2008
CAMPTOSAR
+ PFIZER INC 300MG/15ML (20MG/ML) N020571 003 Aug 05, 2010
IRON DEXTRAN
INJECTABLE;INJECTION
DEXFERRUM
BP LUITPOLD EQ 50MG IRON/ML N040024 001 Feb 23, 1996
INFED
BP + WATSON LABS (UTAH) EQ 50MG IRON/ML N017441 001
PROFERDEX
BP NEW RIVER EQ 50MG IRON/ML N017807 001
IRON SUCROSE
INJECTABLE;INTRAVENOUS
VENOFER
LUITPOLD EQ 50MG BASE/2.5ML (EQ 20MG BASE/ML) N021135 002 Mar 20, 2005
+ EQ 100MG BASE/5ML (EQ 20MG BASE/ML) N021135 001 Nov 06, 2000
EQ 200MG BASE/10ML (EQ 20MG BASE/ML) N021135 004 Feb 09, 2007
ISOCARBOXAZID
TABLET;ORAL
MARPLAN
+ VALIDUS PHARMS INC 10MG N011961 001
ISOFLURANE
LIQUID;INHALATION
FORANE
AN + BAXTER HLTHCARE 99.9% N017624 001
ISOFLURANE
AN HALOCARBON PRODS 99.9% A075225 001 Oct 20, 1999
AN HOSPIRA 99.9% A074097 001 Jan 25, 1993
AN PIRAMAL CRITICAL 99.9% A074416 001 Sep 30, 1994
AN RHODIA 99.9% A074502 001 Jun 27, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-198( of 362)
ISONIAZID
INJECTABLE;INJECTION
ISONIAZID
+ SANDOZ 100MG/ML A040648 001 Jul 05, 2005
SYRUP;ORAL
ISONIAZID
+ CAROLINA MEDCL 50MG/5ML A088235 001 Nov 10, 1983
TABLET;ORAL
ISONIAZID
AA BARR 100MG A080936 001
AA 300MG A080937 002
AA + SANDOZ 100MG N008678 002
AA + 300MG N008678 003
LANIAZID
AA LANNETT 300MG A089776 001 Jun 13, 1988
ISONIAZID; PYRAZINAMIDE; RIFAMPIN
TABLET;ORAL
RIFATER
+ SANOFI AVENTIS US 50MG;300MG;120MG N050705 001 May 31, 1994
ISONIAZID; RIFAMPIN
CAPSULE;ORAL
RIFAMATE
+ SANOFI AVENTIS US 150MG;300MG A061884 001
ISOPROTERENOL HYDROCHLORIDE
INJECTABLE;INJECTION
ISUPREL
+ HOSPIRA 0.2MG/ML N010515 001
ISOSORBIDE DINITRATE
CAPSULE, EXTENDED RELEASE;ORAL
DILATRATE-SR
+ ACTIENT PHARMS 40MG N019790 001 Sep 02, 1988
TABLET;ORAL
ISORDIL
AB VALEANT BERMUDA 5MG N012093 007 Jul 29, 1988
AB 10MG N012093 002 Jul 29, 1988
AB 20MG N012093 006 Jul 29, 1988
AB + 30MG N012093 005 Jul 29, 1988
ISOSORBIDE DINITRATE
AB PAR PHARM 5MG A086923 001 Mar 12, 1987
AB 10MG A086925 001 Mar 12, 1987
AB 20MG A087537 001 Oct 02, 1987
AB 30MG A087946 001 Jan 12, 1988
AB SANDOZ 5MG A086221 001 Jan 07, 1988
AB 10MG A086223 001 Jan 07, 1988
AB 20MG A089367 001 Apr 07, 1988
AB WEST WARD 5MG A086067 001 Oct 29, 1987
AB 10MG A086066 001 Oct 29, 1987
AB 20MG A088088 001 Nov 02, 1987
AB 30MG A040591 001 Jan 10, 2007
ISORDIL
+ VALEANT BERMUDA 40MG N012093 001 Jul 29, 1988
TABLET, EXTENDED RELEASE;ORAL
ISOSORBIDE DINITRATE
AB + CARACO 40MG A040009 001 Dec 30, 1998
AB COREPHARMA 40MG A040723 001 Mar 17, 2008
ISOSORBIDE MONONITRATE
TABLET;ORAL
ISOSORBIDE MONONITRATE
AB ACTAVIS ELIZABETH 10MG A075037 002 Oct 30, 1998
AB 20MG A075037 001 Oct 30, 1998
AB TEVA 20MG A075147 001 Nov 27, 1998
AB WEST WARD 20MG A075361 001 Oct 05, 2000
MONOKET
AB KREMERS URBAN PHARMS 10MG N020215 002 Jun 30, 1993
AB + 20MG N020215 001 Jun 30, 1993
TABLET, EXTENDED RELEASE;ORAL
ISOSORBIDE MONONITRATE
AB ACTAVIS ELIZABETH 30MG A075306 001 Dec 31, 1998
AB 60MG A075306 002 Dec 31, 1998
AB DEXCEL LTD 60MG A075522 001 Apr 17, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-199( of 362)
ISOSORBIDE MONONITRATE
TABLET, EXTENDED RELEASE;ORAL
ISOSORBIDE MONONITRATE
AB HIKMA PHARMS 30MG A076813 002 Mar 30, 2006
AB 60MG A076813 001 Jan 07, 2005
AB KREMERS URBAN PHARMS 30MG A075155 002 Jan 13, 2000
AB 60MG A075155 001 Oct 30, 1998
AB + 120MG A075155 003 Aug 04, 2000
AB NESHER PHARMS 30MG A075395 001 Mar 16, 2000
AB 60MG A075395 002 Mar 16, 2000
AB 120MG A075395 003 Mar 16, 2000
AB TORRENT PHARMS 30MG A200270 001 Jun 03, 2011
AB 60MG A200495 001 Jun 03, 2011
AB 120MG A200495 002 Jun 03, 2011
AB VINTAGE PHARMS 30MG A090598 001 Aug 11, 2010
AB 60MG A090598 002 Aug 11, 2010
AB 120MG A090598 003 Aug 11, 2010
ISOSULFAN BLUE
INJECTABLE;INJECTION
ISOSULFAN BLUE
AP MYLAN INSTITUTIONAL 1% A090874 001 Jul 20, 2010
LYMPHAZURIN
AP + COVIDIEN 1% N018310 001
ISOTRETINOIN
CAPSULE;ORAL
AMNESTEEM
AB MYLAN PHARMS INC 10MG A075945 001 Nov 08, 2002
AB 20MG A075945 002 Nov 08, 2002
AB 40MG A075945 003 Nov 08, 2002
CLARAVIS
AB TEVA PHARMS USA 10MG A076356 001 Apr 11, 2003
AB 20MG A076135 002 Apr 11, 2003
AB 30MG A076135 003 May 11, 2006
AB + 40MG A076135 001 Apr 11, 2003
MYORISAN
AB DOUGLAS PHARMS 10MG A076485 001 Jan 19, 2012
AB 20MG A076485 002 Jan 19, 2012
AB 40MG A076485 003 Jan 19, 2012
SOTRET
AB RANBAXY 10MG A076041 001 Dec 24, 2002
AB 20MG A076041 002 Dec 24, 2002
AB 30MG A076503 001 Jun 20, 2003
AB 40MG A076041 003 Dec 24, 2002
ZENATANE
AB DR REDDYS LABS LTD 10MG A202099 001 Mar 25, 2013
AB 20MG A202099 002 Mar 25, 2013
AB 40MG A202099 003 Mar 25, 2013
ABSORICA
BX RANBAXY 10MG N021951 001 May 25, 2012
BX 20MG N021951 002 May 25, 2012
BX 30MG N021951 003 May 25, 2012
BX + 40MG N021951 004 May 25, 2012
ISRADIPINE
CAPSULE;ORAL
ISRADIPINE
AB MIKAH PHARMA 2.5MG A077169 001 Apr 24, 2006
AB 5MG A077169 002 Apr 24, 2006
AB WATSON LABS 2.5MG A077317 001 Jan 05, 2006
AB + 5MG A077317 002 Jan 05, 2006
ITRACONAZOLE
CAPSULE;ORAL
ITRACONAZOLE
AB MYLAN PHARMS INC 100MG A200463 001 Jul 20, 2012
AB SANDOZ 100MG A076104 001 May 28, 2004
SPORANOX
AB + JANSSEN PHARMS 100MG N020083 001 Sep 11, 1992
SOLUTION;ORAL
SPORANOX
+ JANSSEN PHARMS 10MG/ML N020657 001 Feb 21, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-200( of 362)
ITRACONAZOLE
TABLET;ORAL
ONMEL
+ MERZ PHARMS 200MG N022484 001 Apr 29, 2010
IVACAFTOR
TABLET;ORAL
KALYDECO
+ VERTEX PHARMS 150MG N203188 001 Jan 31, 2012
IVERMECTIN
LOTION;TOPICAL
SKLICE
+ SANOFI PASTEUR INC 0.5% N202736 001 Feb 07, 2012
TABLET;ORAL
STROMECTOL
+ MERCK SHARP DOHME 3MG N050742 002 Oct 08, 1998
IXABEPILONE
INJECTABLE;IV (INFUSION)
IXEMPRA KIT
+ BRISTOL MYERS SQUIBB 15MG/VIAL N022065 001 Oct 16, 2007
+ 45MG/VIAL N022065 002 Oct 16, 2007
KANAMYCIN SULFATE
INJECTABLE;INJECTION
KANAMYCIN SULFATE
+ FRESENIUS KABI USA EQ 1GM BASE/3ML A065111 002 Dec 17, 2002
EQ 500MG BASE/2ML A065111 001 Dec 17, 2002
KETAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
KETALAR
AP + JHP PHARMS EQ 10MG BASE/ML N016812 001
AP + EQ 50MG BASE/ML N016812 002
AP + EQ 100MG BASE/ML N016812 003
KETAMINE HYDROCHLORIDE
AP BEDFORD EQ 50MG BASE/ML A074524 001 Mar 22, 1996
AP EQ 100MG BASE/ML A074524 002 Mar 22, 1996
AP HOSPIRA EQ 50MG BASE/ML A074549 001 Jun 27, 1996
AP EQ 100MG BASE/ML A074549 002 Jun 27, 1996
AP MYLAN INSTITUTIONAL EQ 10MG BASE/ML A076092 001 Sep 30, 2008
AP EQ 50MG BASE/ML A076092 002 Dec 28, 2001
AP EQ 100MG BASE/ML A076092 003 Oct 25, 2002
KETOCONAZOLE
AEROSOL, FOAM;TOPICAL
EXTINA
AT + STIEFEL LABS INC 2% N021738 001 Jun 12, 2007
KETOCONAZOLE
AT PERRIGO ISRAEL 2% A091550 001 Aug 25, 2011
CREAM;TOPICAL
KETOCONAZOLE
AB FOUGERA PHARMS 2% A076294 001 Apr 28, 2004
AB + TEVA 2% A075581 001 Apr 25, 2000
KETOZOLE
AB TARO 2% A075638 001 Dec 18, 2002
GEL;TOPICAL
XOLEGEL
+ AQUA PHARMS 2% N021946 001 Jul 28, 2006
SHAMPOO;TOPICAL
KETOCONAZOLE
AB PERRIGO NEW YORK 2% A076419 001 Jan 07, 2004
AB TOLMAR 2% A076942 001 Apr 11, 2005
NIZORAL
AB + JANSSEN PHARMS 2% N019927 001 Aug 31, 1990
TABLET;ORAL
KETOCONAZOLE
AB APOTEX 200MG A075912 001 Jan 10, 2002
AB MUTUAL PHARMA 200MG A075314 001 Jun 15, 1999
AB MYLAN 200MG A075597 001 Dec 23, 1999
AB PLIVA 200MG A075362 001 Jun 15, 1999
AB TARO 200MG A075319 001 Jun 15, 1999
AB TEVA 200MG A075273 001 Jun 15, 1999
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-201( of 362)
KETOCONAZOLE
TABLET;ORAL
NIZORAL
AB + ORTHO MCNEIL JANSSEN 200MG N018533 001
KETOPROFEN
CAPSULE;ORAL
KETOPROFEN
AB DORADO PHARMA 50MG A074014 002 Jan 29, 1993
AB 75MG A074014 003 Jan 29, 1993
AB MYLAN 50MG A074035 002 Dec 31, 1996
AB 75MG A074035 003 Dec 31, 1996
AB TEVA 50MG A073516 001 Dec 22, 1992
AB + 75MG A073517 001 Dec 22, 1992
DORADO PHARMA 25MG A074014 001 Jan 29, 1993
CAPSULE, EXTENDED RELEASE;ORAL
KETOPROFEN
AB MYLAN 100MG A075679 003 Feb 20, 2002
AB 150MG A075679 002 Feb 20, 2002
AB + 200MG A075679 001 Feb 20, 2002
AB WATSON LABS FLORIDA 100MG A075270 002 Mar 24, 1999
AB 150MG A075270 003 Mar 24, 1999
AB 200MG A075270 001 Mar 24, 1999
KETOROLAC TROMETHAMINE
INJECTABLE;INJECTION
KETOROLAC TROMETHAMINE
AP AGILA SPECLTS 15MG/ML A078299 001 Jul 16, 2007
AP 30MG/ML A078299 002 Jul 16, 2007
AP + BEDFORD 15MG/ML A075222 001 Apr 26, 1999
AP + 30MG/ML A075222 002 Apr 26, 1999
AP + 30MG/ML A075228 001 Apr 26, 1999
AP FRESENIUS KABI USA 15MG/ML A075784 001 Jan 11, 2002
AP 30MG/ML A075784 002 Jan 11, 2002
AP HIKMA MAPLE 15MG/ML A075299 001 Nov 03, 1999
AP 15MG/ML A075772 001 Jul 21, 2004
AP 30MG/ML A075299 002 Nov 03, 1999
AP 30MG/ML A075772 002 Jul 21, 2004
AP HOSPIRA 15MG/ML A074802 001 Jun 05, 1997
AP 15MG/ML A074993 001 Jan 27, 1999
AP 30MG/ML A074802 002 Jun 05, 1997
AP 30MG/ML A074993 002 Jan 27, 1999
AP SAGENT PHARMS 15MG/ML A091065 001 Nov 27, 2013
AP 30MG/ML A091065 002 Nov 27, 2013
AP SANDOZ 15MG/ML A076271 001 Oct 06, 2004
AP 30MG/ML A076271 002 Oct 06, 2004
AP SUN PHARMA GLOBAL 15MG/ML A078737 001 Oct 06, 2008
AP 30MG/ML A078737 002 Oct 06, 2008
AP WOCKHARDT 15MG/ML A077942 001 Mar 27, 2007
AP 30MG/ML A077942 002 Mar 27, 2007
AP 30MG/ML A077943 001 Mar 27, 2007
SOLUTION/DROPS;OPHTHALMIC
ACULAR
AT + ALLERGAN 0.5% N019700 001 Nov 09, 1992
ACULAR LS
AT + ALLERGAN 0.4% N021528 001 May 30, 2003
KETOROLAC TROMETHAMINE
AT AKORN 0.4% A078399 001 Nov 05, 2009
AT 0.5% A078434 001 Nov 05, 2009
AT ALCON PHARMS LTD 0.4% A078721 001 Nov 05, 2009
AT 0.5% A076583 001 Nov 05, 2009
AT APOTEX INC 0.4% A077308 001 Nov 05, 2009
AT 0.5% A076109 001 Nov 05, 2009
AT SUN PHARMA GLOBAL 0.5% A090017 001 Nov 05, 2009
ACUVAIL
+ ALLERGAN 0.45% N022427 001 Jul 22, 2009
SPRAY, METERED;NASAL
SPRIX
+ LUITPOLD 15.75MG/SPRAY N022382 001 May 14, 2010
TABLET;ORAL
KETOROLAC TROMETHAMINE
AB + MYLAN 10MG A074761 001 May 16, 1997
AB PLIVA 10MG A075284 001 Jun 23, 1999
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-202( of 362)
KETOROLAC TROMETHAMINE
TABLET;ORAL
KETOROLAC TROMETHAMINE
AB TEVA 10MG A074754 001 May 16, 1997
LABETALOL HYDROCHLORIDE
INJECTABLE;INJECTION
LABETALOL HYDROCHLORIDE
AP AKORN INC 5MG/ML A075431 001 Nov 29, 1999
AP 5MG/ML A075524 001 Nov 29, 1999
AP BEDFORD 5MG/ML A075303 001 May 28, 1999
AP GLAND PHARMA LTD 5MG/ML A090699 001 Apr 03, 2012
AP + HOSPIRA 5MG/ML A075239 001 Nov 29, 1999
AP + 5MG/ML A075240 001 Nov 29, 1999
LABETALOL HYDROCLORIDE
AP SAGENT STRIDES 5MG/ML A079134 001 Feb 03, 2010
TABLET;ORAL
LABETALOL HYDROCHLORIDE
AB IVAX SUB TEVA PHARMS 100MG A074787 001 Aug 03, 1998
AB 200MG A074787 002 Aug 03, 1998
AB 300MG A074787 003 Aug 03, 1998
AB PAR FORM 100MG A200908 001 Jul 10, 2012
AB 200MG A200908 002 Jul 10, 2012
AB 300MG A200908 003 Jul 10, 2012
AB SANDOZ 100MG A075113 001 Aug 04, 1998
AB + 200MG A075113 002 Aug 04, 1998
AB 300MG A075113 003 Aug 04, 1998
AB WATSON LABS 100MG A075133 001 Aug 03, 1998
AB 200MG A075133 002 Aug 03, 1998
AB 300MG A075133 003 Aug 03, 1998
LACOSAMIDE
SOLUTION;INTRAVENOUS
VIMPAT
+ UCB INC 200MG/20ML (10MG/ML) N022254 001 Oct 28, 2008
SOLUTION;ORAL
VIMPAT
+ UCB INC 10MG/ML N022255 001 Apr 20, 2010
TABLET;ORAL
VIMPAT
UCB INC 50MG N022253 001 Oct 28, 2008
100MG N022253 002 Oct 28, 2008
150MG N022253 003 Oct 28, 2008
+ 200MG N022253 004 Oct 28, 2008
LACTULOSE
FOR SOLUTION;ORAL
LACTULOSE
+ CUMBERLAND PHARMS 10GM/PACKET A074712 001 Dec 10, 1997
+ 20GM/PACKET A074712 002 Dec 10, 1997
SOLUTION;ORAL
CONSTILAC
AA ALRA 10GM/15ML A071054 001 Jul 26, 1988
CONSTULOSE
AA + ACTAVIS MID ATLANTIC 10GM/15ML A070288 001 Aug 15, 1988
LACTULOSE
AA ANI PHARMS 10GM/15ML A078430 001 Nov 28, 2007
AA FRESENIUS KABI 10GM/15ML A090503 001 Jan 25, 2012
AA HI TECH PHARMA 10GM/15ML A074076 001 Jul 03, 1995
AA MORTON GROVE 10GM/15ML A074602 001 Nov 14, 1996
AA PHARM ASSOC 10GM/15ML A074623 001 Jul 30, 1996
AA ROXANE 10GM/15ML A073591 001 May 29, 1992
AA VINTAGE PHARMS 10GM/15ML A075993 001 Jul 26, 2001
AA VISTAPHARM 10GM/15ML A074138 001 Sep 30, 1992
SOLUTION;ORAL, RECTAL
CHOLAC
AA ALRA 10GM/15ML A071331 001 Jul 26, 1988
ENULOSE
AA + ACTAVIS MID ATLANTIC 10GM/15ML A071548 001 Aug 15, 1988
GENERLAC
AA MORTON GROVE PHARMS 10GM/15ML A074603 001 Oct 31, 1996
LACTULOSE
AA ANI PHARMS 10GM/15ML A090426 001 Nov 21, 2008
AA FRESENIUS KABI 10GM/15ML A090502 001 Jan 25, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-203( of 362)
LACTULOSE
SOLUTION;ORAL, RECTAL
LACTULOSE
AA HI TECH PHARMA 10GM/15ML A074077 001 Jul 03, 1995
LAMIVUDINE
SOLUTION;ORAL
EPIVIR
+ VIIV HLTHCARE 10MG/ML N020596 001 Nov 17, 1995
EPIVIR-HBV
+ GLAXOSMITHKLINE 5MG/ML N021004 001 Dec 08, 1998
TABLET;ORAL
EPIVIR
AB VIIV HLTHCARE 150MG N020564 001 Nov 17, 1995
AB + 300MG N020564 003 Jun 24, 2002
EPIVIR-HBV
AB + GLAXOSMITHKLINE 100MG N021003 001 Dec 08, 1998
LAMIVUDINE
AB APOTEX 150MG A091606 001 Dec 02, 2011
AB 300MG A091606 002 Dec 02, 2011
AB APOTEX INC 100MG A202941 001 Jan 02, 2014
AB AUROBINDO PHARMA LTD 150MG A202032 001 Nov 17, 2011
AB 300MG A202032 002 Nov 17, 2011
AB HETERO LABS LTD V 100MG A203260 001 Jan 02, 2014
AB 150MG A203277 001 Jan 06, 2014
AB 300MG A203277 002 Jan 06, 2014
LAMIVUDINE; ZIDOVUDINE
TABLET;ORAL
COMBIVIR
AB + VIIV HLTHCARE 150MG;300MG N020857 001 Sep 26, 1997
LAMIVUDINE AND ZIDOVUDINE
AB AUROBINDO PHARMA LTD 150MG;300MG A202418 001 May 15, 2012
AB LUPIN LTD 150MG;300MG A090246 001 May 15, 2012
AB TEVA PHARMS 150MG;300MG A079081 001 May 25, 2011
LAMOTRIGINE
TABLET;ORAL
LAMICTAL
AB + GLAXOSMITHKLINE LLC 25MG N020241 005 Dec 27, 1994
AB 100MG N020241 001 Dec 27, 1994
AB 150MG N020241 002 Dec 27, 1994
AB 200MG N020241 003 Dec 27, 1994
LAMOTRIGINE
AB ACTAVIS TOTOWA 25MG A078669 001 Apr 08, 2011
AB 100MG A078669 002 Apr 08, 2011
AB 150MG A078669 003 Apr 08, 2011
AB 200MG A078669 004 Apr 08, 2011
AB ALEMBIC PHARMS LTD 25MG A090607 001 Jan 13, 2011
AB 100MG A090607 002 Jan 13, 2011
AB 150MG A090607 003 Jan 13, 2011
AB 200MG A090607 004 Jan 13, 2011
AB ALKEM LABS LTD 25MG A200694 001 Jun 14, 2013
AB 100MG A200694 002 Jun 14, 2013
AB 150MG A200694 003 Jun 14, 2013
AB 200MG A200694 004 Jun 14, 2013
AB APOTEX INC 25MG A078625 001 Jan 27, 2009
AB 100MG A078625 002 Jan 27, 2009
AB 150MG A078625 003 Jan 27, 2009
AB 200MG A078625 004 Jan 27, 2009
AB AUROBINDO PHARMA 25MG A078956 001 Jan 27, 2009
AB 100MG A078956 002 Jan 27, 2009
AB 150MG A078956 003 Jan 27, 2009
AB 200MG A078956 004 Jan 27, 2009
AB CADISTA PHARMS 25MG A079132 001 Jan 27, 2009
AB 100MG A079132 002 Jan 27, 2009
AB 150MG A079132 003 Jan 27, 2009
AB 200MG A079132 004 Jan 27, 2009
AB CIPLA LTD 25MG A077783 001 Nov 01, 2010
AB 100MG A077783 002 Nov 01, 2010
AB 150MG A077783 003 Nov 01, 2010
AB 200MG A077783 004 Nov 01, 2010
AB DR REDDYS LABS LTD 25MG A076708 001 Jan 27, 2009
AB 100MG A076708 002 Jan 27, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-204( of 362)
LAMOTRIGINE
TABLET;ORAL
LAMOTRIGINE
AB 150MG A076708 003 Jan 27, 2009
AB 200MG A076708 004 Jan 27, 2009
AB GLENMARK GENERICS 25MG A090169 001 May 12, 2012
AB 100MG A090169 002 May 12, 2012
AB 150MG A090169 003 May 12, 2012
AB 200MG A090169 004 May 12, 2012
AB HIKMA PHARMS 25MG A078134 001 Apr 19, 2011
AB 100MG A078134 002 Apr 19, 2011
AB 150MG A078134 003 Apr 19, 2011
AB 200MG A078134 004 Apr 19, 2011
AB LUPIN LTD 25MG A078691 001 Jun 01, 2010
AB 100MG A078691 002 Jun 01, 2010
AB 150MG A078691 003 Jun 01, 2010
AB 200MG A078691 004 Jun 01, 2010
AB MYLAN 25MG A077420 001 Jan 27, 2009
AB 100MG A077420 002 Jan 27, 2009
AB 150MG A077420 003 Jan 27, 2009
AB 200MG A077420 004 Jan 27, 2009
AB TARO PHARM INDS 25MG A078525 001 Jan 27, 2009
AB 100MG A078525 002 Jan 27, 2009
AB 150MG A078525 003 Jan 27, 2009
AB 200MG A078525 004 Jan 27, 2009
AB TEVA 25MG A076388 001 Aug 30, 2006
AB 100MG A076388 002 Aug 30, 2006
AB 150MG A076388 003 Aug 30, 2006
AB 200MG A076388 004 Aug 30, 2006
AB TORRENT PHARMS 25MG A078947 001 Jan 27, 2009
AB 100MG A078947 002 Jan 27, 2009
AB 150MG A078947 003 Jan 27, 2009
AB 200MG A078947 004 Jan 27, 2009
AB UNICHEM LABS LTD 25MG A090170 001 Oct 06, 2011
AB 100MG A090170 002 Oct 06, 2011
AB 150MG A090170 003 Oct 06, 2011
AB 200MG A090170 004 Oct 06, 2011
AB ZYDUS PHARMS USA 25MG A077633 001 Jan 27, 2009
AB 100MG A077633 003 Jan 27, 2009
AB 150MG A077633 004 Jan 27, 2009
AB 200MG A077633 005 Jan 27, 2009
BX UPSHER SMITH 25MG A078310 001 Feb 04, 2009
BX 100MG A078310 002 Feb 04, 2009
BX 150MG A078310 003 Feb 04, 2009
BX 200MG A078310 004 Feb 04, 2009
ZYDUS PHARMS USA 50MG A077633 002 Jan 27, 2009
250MG A077633 006 Jan 27, 2009
TABLET, CHEWABLE;ORAL
LAMICTAL CD
AB GLAXOSMITHKLINE LLC 2MG N020764 004 Sep 08, 2000
AB 5MG N020764 001 Aug 24, 1998
AB + 25MG N020764 002 Aug 24, 1998
LAMOTRIGINE
AB AUROBINDO PHARMA 5MG A090401 002 Nov 04, 2009
AB 25MG A090401 003 Nov 04, 2009
AB DR REDDYS LABS LTD 5MG A076701 001 Jan 22, 2009
AB 25MG A076701 002 Jan 22, 2009
AB GLENMARK GENERICS 5MG A079099 001 Feb 19, 2009
AB 25MG A079099 002 Feb 19, 2009
AB JUBILANT LIFE 5MG A200220 001 Feb 28, 2011
AB 25MG A200220 002 Feb 28, 2011
AB MYLAN 5MG A076630 001 Jan 22, 2009
AB 25MG A076630 002 Jan 22, 2009
AB TARO 5MG A079204 001 Feb 04, 2009
AB 25MG A079204 002 Feb 04, 2009
AB TEVA 5MG A076420 001 Jun 21, 2006
AB 25MG A076420 002 Jun 21, 2006
AB WATSON LABS 2MG A076928 001 Jan 22, 2009
AB 5MG A076928 002 Jan 22, 2009
AB 25MG A076928 003 Jan 22, 2009
AB ZYDUS PHARMS USA INC 5MG A078009 002 Jan 22, 2009
AB 25MG A078009 003 Jan 22, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
LAMOTRIGINE
TABLET, EXTENDED RELEASE;ORAL
LAMICTAL XR
AB GLAXOSMITHKLINE LLC
AB +
AB
AB
AB
AB
LAMOTRIGINE
AB ACTAVIS ELIZABETH
AB
AB
AB
AB
AB
AB ANCHEN PHARMS
AB
AB
AB
AB
AB
AB DR REDDYS LABS LTD
AB
AB
AB
AB
AB PAR PHARM
AB
AB
AB
AB
AB
AB TORRENT PHARMS LTD
AB
AB
AB
AB WILSHIRE PHARMS INC
AB
AB
AB
AB WOCKHARDT LTD
AB
AB
AB
AB
25MG
50MG
100MG
200MG
250MG
300MG
100MG
200MG
25MG
50MG
250MG
300MG
25MG
50MG
100MG
200MG
250MG
300MG
25MG
50MG
100MG
200MG
300MG
25MG
50MG
100MG
200MG
250MG
300MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
300MG
TABLET, ORALLY DISINTEGRATING;ORAL
LAMICTAL ODT
AB GLAXOSMITHKLINE LLC 25MG
AB +
AB
AB
LAMOTRIGINE
AB WATSON LABS INC
AB
AB
AB
LANREOTIDE ACETATE
INJECTABLE;SUBCUTANEOUS
SOMATULINE DEPOT
+ IPSEN PHARMA
+
+
LANSOPRAZOLE
50MG
100MG
200MG
25MG
50MG
100MG
200MG
EQ 60MG BASE
EQ 90MG BASE
EQ 120MG BASE
CAPSULE, DELAYED REL PELLETS;ORAL
LANSOPRAZOLE
AB DR REDDYS LABS LTD
AB
AB MYLAN PHARMS INC
AB
AB NATCO PHARMA LTD
15MG
30MG
15MG
30MG
15MG
3-205( of 362)
N022115 001 May 29, 2009
N022115 002 May 29, 2009
N022115 003 May 29, 2009
N022115 004 May 29, 2009
N022115 006 Jun 21, 2011
N022115 005 Apr 14, 2010
A200672 003 Oct 17, 2013
A200672 004 Oct 17, 2013
A200672 001 Oct 17, 2013
A200672 002 Oct 17, 2013
A203733 001 Nov 13, 2013
A200672 005 Oct 17, 2013
A201374 001 Dec 26, 2012
A201374 002 Dec 26, 2012
A201374 003 Dec 26, 2012
A201374 004 Dec 26, 2012
A201374 005 Dec 26, 2012
A201374 006 Dec 26, 2012
A202383 001 Jun 19, 2013
A202383 002 Jun 19, 2013
A202383 003 Jun 19, 2013
A202383 004 Jun 19, 2013
A202383 005 Jun 19, 2013
A201791 001 Jan 18, 2013
A201791 002 Jan 18, 2013
A201791 003 Jan 18, 2013
A201791 004 Jan 18, 2013
A201791 005 Jan 18, 2013
A201791 006 Jan 18, 2013
A203370 001 Dec 23, 2013
A203370 002 Dec 23, 2013
A203370 003 Dec 23, 2013
A203370 004 Dec 23, 2013
A202887 001 Jun 17, 2013
A202887 002 Jun 17, 2013
A202887 003 Jun 17, 2013
A202887 004 Jun 17, 2013
A202498 001 Jan 04, 2013
A202498 002 Jan 04, 2013
A202498 003 Jan 04, 2013
A202498 004 Jan 04, 2013
A202498 005 Jan 04, 2013
N022251 001 May 08, 2009
N022251 002 May 08, 2009
N022251 003 May 08, 2009
N022251 004 May 08, 2009
A200828 001 Jul 15, 2013
A200828 002 Jul 15, 2013
A200828 003 Jul 15, 2013
A200828 004 Jul 15, 2013
N022074 001 Aug 30, 2007
N022074 002 Aug 30, 2007
N022074 003 Aug 30, 2007
A091269 001 Oct 15, 2010
A091269 002 Oct 15, 2010
A090763 001 Nov 10, 2009
A090763 002 Nov 10, 2009
A201921 001 Dec 18, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
LANSOPRAZOLE
CAPSULE, DELAYED REL PELLETS;ORAL
LANSOPRAZOLE
AB 30MG
AB SANDOZ 15MG
AB 30MG
AB SUN PHARMA GLOBAL 15MG
AB 30MG
AB TEVA PHARMS 15MG
AB 30MG
AB WOCKHARDT USA 15MG
AB 30MG
AB ZYDUS HLTHCARE 15MG
AB 30MG
LANSOPRAZOLE
AB KRKA TOVARNA ZDRAVIL 15MG
AB 30MG
PREVACID
AB TAKEDA PHARMS USA 15MG
AB + 30MG
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL
PREVACID
TAKEDA PHARMS USA
+
LANTHANUM CARBONATE
TABLET, CHEWABLE;ORAL
FOSRENOL
+ SHIRE LLC
LAPATINIB DITOSYLATE
TABLET;ORAL
TYKERB
+ SMITHKLINE BEECHAM
LATANOPROST
SOLUTION/DROPS;OPHTHALMIC
LATANOPROST
AT AKORN
AT ALCON RES
AT BAUSCH AND LOMB
AT DR REDDYS LABS LTD
AT LUITPOLD
AT MYLAN
XALATAN
AT + PHARMACIA AND UPJOHN
LEFLUNOMIDE
TABLET;ORAL
ARAVA
AB SANOFI AVENTIS US
AB +
LEFLUNOMIDE
AB ALEMBIC PHARMS LTD
AB
AB APOTEX INC
AB
AB BARR
AB
AB HERITAGE PHARMS INC
AB
AB SANDOZ
AB
AB TEVA PHARMS
AB
ARAVA
+ SANOFI AVENTIS US
15MG
30MG
EQ 1GM BASE
EQ 500MG BASE
EQ 750MG BASE
EQ 250MG BASE
0.005%
0.005%
0.005%
0.005%
0.005%
0.005%
0.005%
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
100MG
3-206( of 362)
A201921 002 Dec 18, 2012
A090331 001 Apr 23, 2010
A090331 002 Apr 23, 2010
A202637 001 Sep 13, 2013
A091509 001 Sep 13, 2013
A077255 001 Nov 10, 2009
A077255 002 Nov 10, 2009
A202176 001 Sep 14, 2012
A202176 002 Sep 14, 2012
A202366 001 Aug 19, 2013
A202366 002 Aug 19, 2013
A091212 001 Sep 16, 2013
A091212 002 Sep 16, 2013
N020406 001 May 10, 1995
N020406 002 May 10, 1995
N021428 001 Aug 30, 2002
N021428 002 Aug 30, 2002
N021468 004 Nov 23, 2005
N021468 002 Oct 26, 2004
N021468 003 Nov 23, 2005
N022059 001 Mar 13, 2007
A090887 001 Jul 19, 2011
A091449 001 Mar 22, 2011
A201006 001 Mar 22, 2011
A202077 001 Feb 11, 2013
A200925 001 Mar 22, 2011
A201786 001 Mar 22, 2011
N020597 001 Jun 05, 1996
N020905 001 Sep 10, 1998
N020905 002 Sep 10, 1998
A091369 001 Nov 21, 2011
A091369 002 Nov 21, 2011
A077090 001 Sep 13, 2005
A077090 002 Sep 13, 2005
A077083 001 Sep 13, 2005
A077083 002 Sep 13, 2005
A077086 001 Sep 13, 2005
A077086 002 Sep 13, 2005
A077087 001 Sep 13, 2005
A077087 002 Sep 13, 2005
A077084 001 Sep 13, 2005
A077084 002 Sep 13, 2005
N020905 003 Sep 10, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-207( of 362)
LENALIDOMIDE
CAPSULE;ORAL
REVLIMID
CELGENE 2.5MG N021880 005 Dec 21, 2011
5MG N021880 001 Dec 27, 2005
10MG N021880 002 Dec 27, 2005
15MG N021880 003 Jun 29, 2006
20MG N021880 006 Jun 05, 2013
+ 25MG N021880 004 Jun 29, 2006
LETROZOLE
TABLET;ORAL
FEMARA
AB + NOVARTIS PHARMS 2.5MG N020726 001 Jul 25, 1997
LETROZOLE
AB ACCORD HLTHCARE 2.5MG A090934 001 Jun 03, 2011
AB ACTAVIS TOTOWA 2.5MG A090292 001 Jul 13, 2011
AB APOTEX INC 2.5MG A091303 001 Apr 19, 2012
AB DR REDDYS LABS LTD 2.5MG A091191 001 Jun 03, 2011
AB FRESENIUS KABI ONCOL 2.5MG A090491 001 Jun 03, 2011
AB IMPAX LABS 2.5MG A091638 001 Jun 03, 2011
AB INDICUS PHARMA 2.5MG A201804 001 Jun 03, 2011
AB JIANGSU HENGRUI MED 2.5MG A202716 001 May 16, 2013
AB KUDCO IRELAND 2.5MG A091098 001 Jun 03, 2011
AB MYLAN 2.5MG A078190 001 Dec 24, 2008
AB NATCO PHARMA LTD 2.5MG A200161 001 Jun 03, 2011
AB ROXANE 2.5MG A090838 001 Jun 03, 2011
AB SUN PHARM INDS LTD 2.5MG A091466 001 Jun 03, 2011
AB TEVA PHARMS 2.5MG A090289 001 Jun 03, 2011
AB VINTAGE PHARMS LLC 2.5MG A090789 001 Jun 03, 2011
LEUCOVORIN CALCIUM
INJECTABLE;INJECTION
LEUCOVORIN CALCIUM
AP + BEDFORD EQ 50MG BASE/VIAL A089384 001 Sep 14, 1987
AP + EQ 100MG BASE/VIAL A089717 001 Mar 28, 1988
AP TEVA PHARMS USA EQ 100MG BASE/VIAL A081277 001 Sep 28, 1993
AP EQ 350MG BASE/VIAL A040174 001 Jun 12, 1997
LEUCOVORIN CALCIUM PRESERVATIVE FREE
AP + BEDFORD EQ 200MG BASE/VIAL A040056 001 May 23, 1995
AP + EQ 350MG BASE/VIAL A040335 001 Apr 20, 2000
AP FRESENIUS KABI USA EQ 200MG BASE/VIAL A040258 001 Feb 26, 1999
AP SAGENT PHARMS EQ 50MG BASE/VIAL A200753 001 Sep 06, 2012
AP EQ 100MG BASE/VIAL A200753 002 Sep 06, 2012
AP EQ 200MG BASE/VIAL A200753 003 Sep 06, 2012
AP EQ 350MG BASE/VIAL A200855 001 Sep 06, 2012
+ BEDFORD EQ 10MG BASE/ML A040347 001 Apr 25, 2000
+ FRESENIUS KABI USA EQ 500MG BASE/VIAL A040286 001 Feb 26, 1999
TABLET;ORAL
LEUCOVORIN CALCIUM
AB BARR EQ 5MG BASE A071198 001 Sep 24, 1987
AB EQ 25MG BASE A071199 001 Sep 24, 1987
AB ROXANE EQ 5MG BASE A072733 001 Feb 22, 1993
AB EQ 15MG BASE A072735 001 Feb 22, 1993
AB + EQ 25MG BASE A072736 001 Feb 22, 1993
EQ 10MG BASE A072734 001 Feb 22, 1993
LEUPROLIDE ACETATE
INJECTABLE;INJECTION
LEUPROLIDE ACETATE
AP + SANDOZ 1MG/0.2ML A074728 001 Aug 04, 1998
AP SUN PHARMA GLOBAL 1MG/0.2ML A078885 001 Mar 09, 2009
AP TEVA PHARMS USA 1MG/0.2ML A075471 001 Oct 25, 2000
LUPRON DEPOT
+ ABBVIE ENDOCRINE INC 3.75MG/VIAL N020011 001 Oct 22, 1990
+ 7.5MG/VIAL N019732 001 Jan 26, 1989
+ 11.25MG/VIAL N020708 001 Mar 07, 1997
+ 22.5MG/VIAL N020517 001 Dec 22, 1995
+ 30MG/VIAL N020517 002 May 30, 1997
45MG/VIAL N020517 003 Jun 17, 2011
LUPRON DEPOT-PED
+ ABBVIE ENDOCRINE INC 7.5MG/VIAL N020263 002 Apr 16, 1993
+ 11.25MG/VIAL N020263 005 Jan 21, 1994
+ 11.25MG/VIAL N020263 007 Aug 15, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-208( of 362)
LEUPROLIDE ACETATE
INJECTABLE;INJECTION
LUPRON DEPOT-PED
+ 15MG/VIAL N020263 006 Jan 21, 1994
+ 30MG/VIAL N020263 008 Aug 15, 2011
INJECTABLE;SUBCUTANEOUS
ELIGARD
+ TOLMAR THERAP 7.5MG/VIAL N021343 001 Jan 23, 2002
+ 22.5MG/VIAL N021379 001 Jul 24, 2002
+ 30MG/VIAL N021488 001 Feb 13, 2003
+ 45MG/VIAL N021731 001 Dec 14, 2004
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL
LUPANETA PACK
ABBVIE ENDOCRINE 3.75MG/VIAL,N/A;N/A,5MG N203696 001 Dec 14, 2012
+ 11.25MG/VIAL,N/A;N/A,5MG N203696 002 Dec 14, 2012
LEVALBUTEROL HYDROCHLORIDE
SOLUTION;INHALATION
LEVALBUTEROL HYDROCHLORIDE
AN CIPLA LTD EQ 0.021% BASE A078171 002 Dec 13, 2013
AN EQ 0.042% BASE A078171 003 Dec 13, 2013
AN EQ 0.0103% BASE A078171 001 Dec 13, 2013
AN DEY EQ 0.0103% BASE A077800 001 Mar 15, 2013
AN EQ 0.021% BASE A077800 002 Mar 15, 2013
AN EQ 0.042% BASE A077800 003 Mar 15, 2013
AN MYLAN SPECLT EQ 0.25% BASE A078309 001 Mar 20, 2009
AN TEVA PHARMS USA EQ 0.0103% BASE A090297 001 Apr 26, 2013
AN EQ 0.021% BASE A090297 002 Apr 26, 2013
AN EQ 0.042% BASE A090297 003 Apr 26, 2013
AN WATSON LABS INC EQ 0.0103% BASE A077756 003 Apr 09, 2008
AN EQ 0.021% BASE A077756 001 Apr 09, 2008
AN EQ 0.042% BASE A077756 002 Apr 09, 2008
XOPENEX
AN + SUNOVION EQ 0.0103% BASE N020837 003 Jan 30, 2002
AN + EQ 0.021% BASE N020837 001 Mar 25, 1999
AN + EQ 0.042% BASE N020837 002 Mar 25, 1999
AN + EQ 0.25% BASE N020837 004 Jul 18, 2003
LEVALBUTEROL TARTRATE
AEROSOL, METERED;INHALATION
XOPENEX HFA
+ SUNOVION EQ 0.045MG BASE/INH N021730 001 Mar 11, 2005
LEVETIRACETAM
INJECTABLE;IV (INFUSION)
KEPPRA
AP + UCB INC 500MG/5ML (100MG/ML) N021872 001 Jul 31, 2006
LEVETIRACETAM
AP FRESENIUS KABI USA 500MG/5ML (100MG/ML) A090813 001 May 26, 2010
AP HIKMA FARMACEUTICA 500MG/5ML(100MG/ML) A090981 001 Oct 13, 2011
AP HOSPIRA INC 500MG/ML (100MG/ML) A202869 001 Apr 06, 2012
AP LUITPOLD 500MG/5ML (100MG/ML) A202143 001 Jan 31, 2012
AP SAGENT PHARMS 500MG/5ML (100MG/ML) A091627 001 Jun 26, 2013
AP SUN PHARM INDS LTD 500MG/5ML (100MG/ML) A090754 001 Jun 16, 2010
AP X GEN PHARMS 500MG/5ML (100MG/ML) A091485 001 Aug 05, 2011
LEVETIRACETAM IN SODIUM CHLORIDE
+ HQ SPECIALITY PHARMA 500MG/100ML (5MG/ML) N202543 001 Nov 09, 2011
+ 1000MG/100ML (10MG/ML) N202543 002 Nov 09, 2011
+ 1500MG/100ML (15MG/ML) N202543 003 Nov 09, 2011
SOLUTION;ORAL
KEPPRA
AA + UCB INC 100MG/ML N021505 001 Jul 15, 2003
LEVETIRACETAM
AA ACTAVIS MID ATLANTIC 100MG/ML A078976 001 Jan 15, 2009
AA AMNEAL PHARMS 100MG/ML A090992 001 Oct 27, 2009
AA AUROBINDO PHARM 100MG/ML A079063 001 Jan 15, 2009
AA BRECKENRIDGE PHARM 100MG/ML A079120 001 Jan 16, 2009
AA HETERO LABS LTD III 100MG/ML A203052 001 Feb 28, 2013
AA HI-TECH PHARMACAL 100MG/ML A090601 001 Feb 28, 2012
AA LUPIN LTD 100MG/ML A090893 001 Oct 17, 2011
AA ORIT LABS LLC 100MG/ML A203067 001 May 09, 2013
AA ROXANE 100MG/ML A078582 001 Jan 15, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-209( of 362)
LEVETIRACETAM
SOLUTION;ORAL
LEVETIRACETAM
AA SILARX 100MG/ML A090263 001 Apr 03, 2009
AA TARO 100MG/ML A078774 001 Feb 10, 2009
AA TOLMAR 100MG/ML A079107 001 Jan 15, 2009
AA TRIS PHARMA INC 100MG/ML A090461 001 Sep 30, 2010
AA VINTAGE PHARMS 100MG/ML A090079 001 Apr 11, 2012
AA WOCKHARDT 100MG/ML A090028 001 Mar 03, 2010
TABLET;ORAL
KEPPRA
AB + UCB INC 1GM N021035 004 Jan 06, 2006
AB 250MG N021035 001 Nov 30, 1999
AB 500MG N021035 002 Nov 30, 1999
AB 750MG N021035 003 Nov 30, 1999
LEVETIRACETAM
AB ACCORD HLTHCARE 1GM A090843 004 Feb 14, 2011
AB 250MG A090843 001 Feb 14, 2011
AB 500MG A090843 002 Feb 14, 2011
AB 750MG A090843 003 Feb 14, 2011
AB AJANTA PHARMA 1GM A201293 004 Jun 14, 2011
AB 250MG A201293 001 Jun 14, 2011
AB 500MG A201293 002 Jun 14, 2011
AB 750MG A201293 003 Jun 14, 2011
AB APOTEX INC 1GM A078869 004 Mar 13, 2009
AB 250MG A078869 001 Mar 13, 2009
AB 500MG A078869 002 Mar 13, 2009
AB 750MG A078869 003 Mar 13, 2009
AB AUROBINDO PHARMA 1GM A078993 004 Jan 15, 2009
AB 250MG A078993 001 Jan 15, 2009
AB 500MG A078993 002 Jan 15, 2009
AB 750MG A078993 003 Jan 15, 2009
AB BOCA PHARMA LLC 250MG A077319 001 Mar 20, 2009
AB 500MG A077319 002 Mar 20, 2009
AB 750MG A077319 003 Mar 20, 2009
AB BRECKENRIDGE PHARM 1GM A090511 004 Aug 18, 2011
AB 250MG A090511 001 Aug 18, 2011
AB 500MG A090511 002 Aug 18, 2011
AB 750MG A090511 003 Aug 18, 2011
AB DR REDDYS LABS LTD 1GM A078904 001 Jan 15, 2009
AB 250MG A076920 001 Jan 15, 2009
AB 500MG A076920 002 Jan 15, 2009
AB 750MG A076920 003 Jan 15, 2009
AB HETERO LABS LTD III 1GM A090515 004 Oct 08, 2010
AB 250MG A090515 001 Oct 08, 2010
AB 500MG A090515 002 Oct 08, 2010
AB 750MG A090515 003 Oct 08, 2010
AB INVAGEN PHARMS 250MG A078234 001 Jan 15, 2009
AB 500MG A078234 002 Jan 15, 2009
AB 750MG A078234 003 Jan 15, 2009
AB LOTUS PHARM CO LTD 500MG A090906 001 Nov 05, 2010
AB LUPIN 1GM A090025 001 Jan 15, 2009
AB 250MG A078154 001 Jan 15, 2009
AB 500MG A078154 002 Jan 15, 2009
AB 750MG A078154 003 Jan 15, 2009
AB METHAPHARM 1GM A090767 004 Jul 28, 2010
AB 250MG A090767 001 Jul 28, 2010
AB 500MG A090767 002 Jul 28, 2010
AB 750MG A090767 003 Jul 28, 2010
AB MYLAN 1GM A090261 001 Dec 08, 2009
AB 250MG A076919 001 Nov 04, 2008
AB 500MG A076919 002 Nov 04, 2008
AB 750MG A076919 003 Nov 04, 2008
AB ORCHID HLTHCARE 1GM A090484 001 Aug 05, 2010
AB 250MG A078526 001 Jan 15, 2009
AB 500MG A078526 002 Jan 15, 2009
AB 750MG A078526 003 Jan 15, 2009
AB PRINSTON INC 1GM A078106 004 Feb 10, 2009
AB 250MG A078106 001 Feb 10, 2009
AB 500MG A078106 002 Feb 10, 2009
AB 750MG A078106 003 Feb 10, 2009
AB ROXANE 1GM A078042 004 Jan 15, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-210( of 362)
LEVETIRACETAM
TABLET;ORAL
LEVETIRACETAM
AB 250MG A078042 001 Jan 15, 2009
AB 500MG A078042 002 Jan 15, 2009
AB 750MG A078042 003 Jan 15, 2009
AB SANDOZ 1GM A077324 004 Jan 15, 2009
AB 250MG A077324 001 Jan 15, 2009
AB 500MG A077324 002 Jan 15, 2009
AB 750MG A077324 003 Jan 15, 2009
AB TARO 1GM A078960 001 Feb 01, 2010
AB 250MG A078960 004 Feb 01, 2010
AB 500MG A078960 003 Feb 01, 2010
AB 750MG A078960 002 Feb 01, 2010
AB TEVA PHARMS 1GM A078101 004 Jan 15, 2009
AB 250MG A078101 001 Jan 15, 2009
AB 500MG A078101 002 Jan 15, 2009
AB 750MG A078101 003 Jan 15, 2009
AB TORRENT PHARMS 1GM A078858 004 Jan 15, 2009
AB 250MG A078858 001 Jan 15, 2009
AB 500MG A078858 002 Jan 15, 2009
AB 750MG A078858 003 Jan 15, 2009
AB VINTAGE PHARMS 1GM A091491 004 Dec 14, 2010
AB 250MG A091491 001 Dec 14, 2010
AB 500MG A091491 002 Dec 14, 2010
AB 750MG A091491 003 Dec 14, 2010
AB WATSON LABS INC 1GM A078797 001 Jan 15, 2009
AB 250MG A078797 002 Jan 15, 2009
AB 500MG A078797 003 Jan 15, 2009
AB 750MG A078797 004 Jan 15, 2009
AB WOCKHARDT 1GM A079042 004 Jan 15, 2009
AB 250MG A079042 001 Jan 15, 2009
AB 500MG A079042 002 Jan 15, 2009
AB 750MG A079042 003 Jan 15, 2009
AB ZYDUS PHARMS USA INC 1GM A078918 002 Apr 29, 2009
AB 250MG A078918 001 Apr 29, 2009
TABLET, EXTENDED RELEASE;ORAL
KEPPRA XR
AB UCB INC 500MG N022285 001 Sep 12, 2008
AB + 750MG N022285 002 Feb 12, 2009
LEVETIRACETAM
AB ACTAVIS ELIZABETH 500MG A091557 001 Sep 12, 2011
AB 750MG A091557 002 Sep 12, 2011
AB ANCHEN PHARMS 500MG A091360 001 Oct 04, 2011
AB 750MG A091360 002 Oct 04, 2011
AB APOTEX INC 500MG A091261 001 Sep 12, 2011
AB 750MG A091261 002 Sep 12, 2011
AB BOCA PHARMA LLC 500MG A201464 001 May 25, 2012
AB 750MG A201464 002 May 25, 2012
AB LUPIN LTD 500MG A091399 001 Sep 12, 2011
AB 750MG A091399 002 Sep 12, 2011
AB MUTUAL PHARM CO INC 500MG A091285 001 Sep 12, 2011
AB 750MG A091285 002 Sep 12, 2011
AB MYLAN PHARMS INC 500MG A200475 001 Dec 19, 2011
AB 750MG A200475 002 Dec 19, 2011
AB PAR PHARM 500MG A091291 001 Sep 12, 2011
AB 750MG A091291 002 Sep 12, 2011
AB ROUSES POINT PHARMS 500MG A202524 001 Aug 27, 2012
AB 750MG A202524 002 Aug 27, 2012
AB SUN PHARMA GLOBAL 500MG A203059 001 Sep 09, 2013
AB 750MG A203059 002 Sep 09, 2013
AB TEVA PHARMS 500MG A091430 001 Sep 12, 2011
AB 750MG A091430 002 Sep 12, 2011
AB TORRENT PHARMS LTD 500MG A091338 001 May 29, 2012
AB 750MG A091338 002 May 29, 2012
AB VINTAGE PHARMS LLC 500MG A202533 001 Jul 20, 2012
AB 750MG A202533 002 Jul 20, 2012
AB WATSON LABS FLORIDA 500MG A091093 001 Sep 12, 2011
AB 750MG A091093 002 Sep 12, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-211( of 362)
LEVOBUNOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AKBETA
AT AKORN 0.25% A074779 001 Oct 29, 1996
AT 0.5% A074780 001 Oct 29, 1996
BETAGAN
AT + ALLERGAN 0.25% N019814 001 Jun 28, 1989
AT + 0.5% N019219 002 Dec 19, 1985
LEVOBUNOLOL HYDROCHLORIDE
AT BAUSCH AND LOMB 0.25% A074307 001 Mar 04, 1994
AT 0.5% A074326 001 Mar 04, 1994
AT FALCON PHARMS 0.25% A074851 001 Oct 28, 1996
AT 0.5% A074850 001 Oct 28, 1996
LEVOCARNITINE
INJECTABLE;INJECTION
CARNITOR
AP + SIGMA TAU 200MG/ML N020182 001 Dec 16, 1992
LEVOCARNITINE
AP BEDFORD 200MG/ML A075567 001 Mar 29, 2001
AP LUITPOLD 200MG/ML A075861 001 Jun 22, 2001
AP TEVA PHARMS USA 200MG/ML A075881 001 Mar 29, 2001
SOLUTION;ORAL
CARNITOR
AA + SIGMA TAU 1GM/10ML N019257 001 Apr 10, 1986
CARNITOR SF
AA SIGMA TAU 1GM/10ML N019257 002 Mar 28, 2007
LEVOCARNITINE
AA HI TECH PHARMA 1GM/10ML A077399 001 Oct 25, 2007
AA LYNE 1GM/10ML A076851 001 Aug 10, 2004
TABLET;ORAL
CARNITOR
AB + SIGMA TAU 330MG N018948 001 Dec 27, 1985
LEVOCARNITINE
AB COREPHARMA 330MG A076858 001 Sep 20, 2004
LEVOCETIRIZINE DIHYDROCHLORIDE
SOLUTION;ORAL
LEVOCETIRIZINE DIHYDROCHLORIDE
AA SYNTHON PHARMS 2.5MG/5ML A091263 001 Nov 07, 2011
AA TARO PHARM INDS 2.5MG/5ML A202673 001 Jul 26, 2013
XYZAL
AA + UCB INC 2.5MG/5ML N022157 001 Jan 28, 2008
TABLET;ORAL
LEVOCETIRIZINE DIHYDROCHLORIDE
AB DR REDDYS LABS LTD 5MG A090392 001 Feb 24, 2011
AB GLENMARK GENERICS 5MG A090385 001 Feb 24, 2011
AB HETERO LABS LTD III 5MG A091264 001 Jun 29, 2012
AB MICRO LABS LTD INDIA 5MG A202046 001 Sep 17, 2013
AB SANDOZ 5MG A090486 001 Mar 26, 2013
AB SUN PHARMA GLOBAL 5MG A090362 001 Jan 31, 2013
AB SYNTHON PHARMS 5MG A090229 001 Nov 26, 2010
AB TEVA PHARMS 5MG A090199 001 Aug 22, 2011
XYZAL
AB + UCB INC 5MG N022064 001 May 25, 2007
LEVOFLOXACIN
INJECTABLE;INJECTION
LEVAQUIN
AP + JANSSEN PHARMS EQ 500MG/20ML (EQ 25MG/ML) N020635 001 Dec 20, 1996
AP + EQ 750MG/30ML (EQ 25MG/ML) N020635 004 Dec 20, 1996
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + JANSSEN PHARMS EQ 250MG/50ML (EQ 5MG/ML) N020635 002 Dec 20, 1996
AP + EQ 500MG/100ML (EQ 5MG/ML) N020635 003 Dec 20, 1996
AP + EQ 750MG/150ML (EQ 5MG/ML) N020635 005 Dec 20, 1996
LEVOFLOXACIN
AP AUROBINDO PHARMA LTD EQ 500MG/20ML (EQ 25MG/ML) A202328 001 Jan 24, 2013
AP EQ 750MG/30ML (EQ 25MG/ML) A202328 002 Jan 24, 2013
AP CLARIS LIFESCIENCES EQ 500MG/20ML (EQ 25MG/ML) A091436 001 Jun 05, 2013
AP EMCURE PHARMS LTD EQ 500MG/20ML (EQ 25MG/ML) A202590 001 Jan 24, 2013
AP EQ 750MG/30ML (EQ 25MG/ML) A202590 002 Jan 24, 2013
AP SAGENT PHARMS EQ 500MG/20ML (EQ 25MG/ML) A200560 001 Jun 20, 2011
AP EQ 750MG/30ML (EQ 25MG/ML) A200560 002 Jun 20, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
LEVOFLOXACIN
INJECTABLE;INJECTION
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
AP ACS DOBFAR INFO SA
AP
AP
AP CLARIS LIFESCIENCES
AP
AP
AP FRESENIUS KABI USA
AP
AP
AP HIKMA FARMACEUTICA
AP
AP
SOLUTION;ORAL
LEVAQUIN
AA + JANSSEN PHARMS
LEVOFLOXACIN
AA HI TECH PHARMA
SOLUTION/DROPS;OPHTHALMIC
LEVOFLOXACIN
AT AKORN
AT HI TECH PHARMA
AT NEXUS PHARMS
QUIXIN
AT + SANTEN
IQUIX
+ SANTEN
TABLET;ORAL
LEVAQUIN
AB JANSSEN PHARMS
AB
AB +
LEVOFLOXACIN
AB APOTEX INC
AB
AB
AB AUROBINDO PHARMA LTD
AB
AB
AB CIPLA LTD
AB
AB
AB DR REDDYS LABS INC
AB
AB
AB GLENMARK GENERICS
AB
AB
AB LUPIN
AB
AB
AB MACLEODS PHARMS LTD
AB
AB
AB MYLAN
AB
AB
AB ORCHID HLTHCARE
AB
AB
AB SANDOZ
AB
AB
AB TEVA
AB
AB
AB TORRENT PHARMS
AB
AB
AB WATSON LABS INC
EQ 250MG/50ML (EQ 5MG/ML)
EQ 500MG/100ML (EQ 5MG/ML)
EQ 750MG/150ML (EQ 5MG/ML)
EQ 250MG/50ML (EQ 5MG/ML)
EQ 500MG/100ML (EQ 5MG/ML)
EQ 750MG/150ML (EQ 5MG/ML)
EQ 250MG/50ML (EQ 5MG/ML)
EQ 500MG/100ML (EQ 5MG/ML)
EQ 750MG/150ML (EQ 5MG/ML)
EQ 250MG/50ML (EQ 5MG/ML)
EQ 500MG/100ML (EQ5MG/ML)
EQ 750MG/150ML (EQ 5MG/ML)
250MG/10ML
250MG/10ML
0.5%
0.5%
0.5%
0.5%
1.5%
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
500MG
750MG
250MG
3-212( of 362)
A090343 001 Jul 07, 2011
A090343 002 Jul 07, 2011
A090343 003 Jul 07, 2011
A091397 001 Aug 08, 2013
A091397 002 Aug 08, 2013
A091397 003 Aug 08, 2013
A200674 001 Jun 19, 2013
A200674 002 Jun 19, 2013
A200674 003 Jun 19, 2013
A091375 001 Sep 16, 2011
A091375 002 Sep 16, 2011
A091375 003 Sep 16, 2011
N021721 001 Oct 21, 2004
A091678 001 Jun 20, 2011
A090268 001 Dec 20, 2010
A076826 001 Feb 10, 2011
A077700 001 Dec 20, 2010
N021199 001 Aug 18, 2000
N021571 001 Mar 01, 2004
N020634 001 Dec 20, 1996
N020634 002 Dec 20, 1996
N020634 003 Sep 08, 2000
A090787 001 Sep 29, 2011
A090787 002 Sep 29, 2011
A090787 003 Sep 29, 2011
A201043 001 Jun 20, 2011
A201043 002 Jun 20, 2011
A201043 003 Jun 20, 2011
A076890 001 Mar 30, 2012
A076890 002 Mar 30, 2012
A076890 003 Mar 30, 2012
A076710 001 Jun 20, 2011
A076710 002 Jun 20, 2011
A076710 003 Jun 20, 2011
A200250 001 Jun 20, 2011
A200250 002 Jun 20, 2011
A200250 003 Jun 20, 2011
A078424 001 Jun 20, 2011
A078424 002 Jun 20, 2011
A078424 003 Jun 20, 2011
A200839 001 Mar 22, 2012
A200839 002 Mar 22, 2012
A200839 003 Mar 22, 2012
A076276 001 Jun 20, 2011
A076276 002 Jun 20, 2011
A077097 001 Jun 20, 2011
A202200 001 Jan 30, 2012
A202200 002 Jan 30, 2012
A202200 003 Jan 30, 2012
A077438 001 Jun 20, 2011
A077438 002 Jun 20, 2011
A077438 003 Jun 20, 2011
A076361 001 Jun 20, 2011
A076361 002 Jun 20, 2011
A076361 003 Jun 20, 2011
A090722 001 Jun 20, 2011
A090722 002 Jun 20, 2011
A090722 003 Jun 20, 2011
A201484 001 Nov 22, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-213( of 362)
LEVOFLOXACIN
TABLET;ORAL
LEVOFLOXACIN
AB 500MG A201484 002 Nov 22, 2013
AB 750MG A201484 003 Nov 22, 2013
AB WOCKHARDT 250MG A090367 001 Jun 20, 2011
AB 500MG A090367 002 Jun 20, 2011
AB 750MG A090367 003 Jun 20, 2011
AB ZYDUS PHARMS USA INC 250MG A077652 001 Sep 07, 2012
AB 500MG A077652 002 Sep 07, 2012
AB 750MG A077652 003 Sep 07, 2012
LEVOLEUCOVORIN CALCIUM
POWDER;IV (INFUSION)
FUSILEV
+ SPECTRUM PHARMS EQ 50MG BASE/VIAL N020140 001 Mar 07, 2008
SOLUTION;IV (INFUSION)
FUSILEV
+ SPECTRUM PHARMS EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) N020140 002 Apr 29, 2011
LEVOMILNACIPRAN HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
FETZIMA
FOREST LABS INC EQ 20MG BASE N204168 001 Jul 25, 2013
EQ 40MG BASE N204168 002 Jul 25, 2013
EQ 80MG BASE N204168 003 Jul 25, 2013
+ EQ 120MG BASE N204168 004 Jul 25, 2013
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
SCANDONEST L
+ DEPROCO 0.05MG/ML;2% A088388 001 Oct 10, 1984
LEVONORGESTREL
INTRAUTERINE DEVICE;INTRAUTERINE
MIRENA
+ BAYER HLTHCARE 52MG N021225 001 Dec 06, 2000
SKYLA
+ BAYER HLTHCARE 13.5MG N203159 001 Jan 09, 2013
TABLET;ORAL
LEVONORGESTREL
AB
AB
AB
AB
AB
AB
LUPIN LTD
NOVEL LABS INC
PERRIGO R AND D
+ WATSON LABS
WATSON LABS INC
PLAN B
0.75MG
1.5MG
0.75MG
0.75MG
0.75MG
1.5MG
A091328 001 Jan 23, 2013
A202508 001 Feb 22, 2013
A090740 001 Dec 30, 2010
A078665 001 Aug 28, 2009
A078666 001 Jun 24, 2009
A200670 001 Jul 12, 2012
AB + TEVA BRANDED PHARM 0.75MG N021045 002 Aug 24, 2006
LEVORPHANOL TARTRATE
TABLET;ORAL
LEVORPHANOL TARTRATE
ROXANE 2MG A074278 001 Mar 31, 2000
LEVOTHYROXINE SODIUM
CAPSULE;ORAL
TIROSINT
INST BIOCHIMIQUE 0.013MG N022121 001 Aug 01, 2007
INSTITUT BIOCHIMIQUE 0.025MG N021924 002 Oct 13, 2006
0.05MG N021924 003 Oct 13, 2006
0.075MG N021924 004 Oct 13, 2006
0.088MG N021924 010 Oct 02, 2009
0.1MG N021924 005 Oct 13, 2006
0.112MG N021924 008 Oct 02, 2009
0.125MG N021924 006 Oct 13, 2006
0.137MG N021924 009 Oct 02, 2009
+ 0.15MG N021924 007 Oct 13, 2006
POWDER;INTRAVENOUS
LEVOTHYROXINE SODIUM
+ FRESENIUS KABI USA 100MCG/VIAL N202231 001 Jun 24, 2011
+ 200MCG/VIAL N202231 002 Jun 24, 2011
+ 500MCG/VIAL N202231 003 Jun 24, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-214( of 362)
LEVOTHYROXINE SODIUM **
**See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL
SYNTHROID
--> ABBVIE
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
--> +
LEVO-T
--> AB1,AB2
--> AB1,AB2
--> AB1,AB2
--> AB1,AB2
--> AB1,AB2
--> AB1,AB2
--> AB1,AB2
--> AB1,AB2
--> AB1,AB2
--> AB1,AB2
--> AB1,AB2
--> AB1,AB2
0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG
0.3MG
N021402 001
N021402 002
N021402 003
N021402 004
N021402 005
N021402 006
N021402 007
N021402 008
N021402 009
N021402 010
N021402 012
N021402 011
Jul 24, 2002
Jul 24, 2002
Jul 24, 2002
Jul 24, 2002
Jul 24, 2002
Jul 24, 2002
Jul 24, 2002
Jul 24, 2002
Jul 24, 2002
Jul 24, 2002
Jul 24, 2002
Jul 24, 2002
--> ALARA PHARM --> AB1,AB2,AB3 0.025MG N021342 001 Mar 01, 2002
--> --> AB1,AB2,AB3 0.05MG N021342 002 Mar 01, 2002
--> --> AB1,AB2,AB3 0.075MG N021342 003 Mar 01, 2002
--> --> AB1,AB2,AB3 0.088MG N021342 004 Mar 01, 2002
--> --> AB1,AB2,AB3 0.1MG N021342 005 Mar 01, 2002
--> --> AB1,AB2,AB3 0.112MG N021342 006 Mar 01, 2002
--> --> AB1,AB2,AB3 0.125MG N021342 007 Mar 01, 2002
--> --> AB1,AB2,AB3 0.137MG N021342 012 Dec 08, 2003
--> --> AB1,AB2,AB3 0.15MG N021342 008 Mar 01, 2002
--> --> AB1,AB2,AB3 0.175MG N021342 009 Mar 01, 2002
--> --> AB1,AB2,AB3 0.2MG N021342 010 Mar 01, 2002
--> + --> AB1,AB2,AB3 0.3MG N021342 011 Mar 01, 2002
UNITHROID
--> STEVENS J --> AB1,AB2,AB3 0.025MG N021210 001 Aug 21, 2000
--> --> AB1,AB2,AB3 0.05MG N021210 002 Aug 21, 2000
--> --> AB1,AB2,AB3 0.075MG N021210 003 Aug 21, 2000
--> --> AB1,AB2,AB3 0.088MG N021210 004 Aug 21, 2000
--> --> AB1,AB2,AB3 0.1MG N021210 005 Aug 21, 2000
--> --> AB1,AB2,AB3 0.112MG N021210 006 Aug 21, 2000
--> --> AB1,AB2,AB3 0.125MG N021210 007 Aug 21, 2000
--> --> AB1,AB2,AB3 0.137MG N021210 012 Feb 08, 2008
--> --> AB1,AB2,AB3 0.15MG N021210 008 Aug 21, 2000
--> --> AB1,AB2,AB3 0.175MG N021210 009 Aug 21, 2000
--> --> AB1,AB2,AB3 0.2MG N021210 010 Aug 21, 2000
--> + --> AB1,AB2,AB3 0.3MG N021210 011 Aug 21, 2000
LEVOTHYROXINE SODIUM
-->
-->
-->
-->
-->
-->
MYLAN -->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
--> AB1,AB2,
0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
A076187 001
A076187 002
A076187 003
A076187 004
A076187 005
A076187 006
Jun 05, 2002
Jun 05, 2002
Jun 05, 2002
Jun 05, 2002
Jun 05, 2002
Jun 05, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-215( of 362)
LEVOTHYROXINE SODIUM **
**See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL
LEVOTHYROXINE SODIUM
-->
-->
-->
-->
-->
-->
LEVOXYL
AB3,AB4
-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
-->
AB1,AB2,AB3,AB4
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG
0.3MG
A076187 007
A076187 012
A076187 008
A076187 009
A076187 010
A076187 011
Jun 05, 2002
Dec 13, 2006
Jun 05, 2002
Jun 05, 2002
Jun 05, 2002
Jun 05, 2002
--> KING PHARMS R AND D
-->
-->
-->
-->
-->
-->
-->
-->
-->
--> +
LEVOTHROID
--> AB1,AB3
--> AB1,AB3
--> AB1,AB3
--> AB1,AB3
--> AB1,AB3
--> AB1,AB3
--> AB1,AB3
--> AB1,AB3
--> AB1,AB3
--> AB1,AB3
--> AB1,AB3
0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG
N021301 001
N021301 002
N021301 003
N021301 004
N021301 005
N021301 006
N021301 007
N021301 008
N021301 009
N021301 010
N021301 011
May 25, 2001
May 25, 2001
May 25, 2001
May 25, 2001
May 25, 2001
May 25, 2001
May 25, 2001
May 25, 2001
May 25, 2001
May 25, 2001
May 25, 2001
AB4
AB4
AB4
AB4
AB4
AB4
AB4
AB4
AB4
AB4
AB4
AB4 +
LLOYD 0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG
0.3MG
N021116 001 Oct 24, 2002
N021116 002 Oct 24, 2002
N021116 003 Oct 24, 2002
N021116 010 Oct 24, 2002
N021116 004 Oct 24, 2002
N021116 011 Oct 24, 2002
N021116 005 Oct 24, 2002
N021116 012 Dec 07, 2004
N021116 006 Oct 24, 2002
N021116 007 Oct 24, 2002
N021116 008 Oct 24, 2002
N021116 009 Oct 24, 2002
LIDOCAINE
OINTMENT;TOPICAL
LIDOCAINE
AT + FOUGERA 5% A080198 001
AT
AT
NOVOCOL INC
TARO
5%
5%
A040911 001 May 23, 2011
A086724 001
PATCH;TOPICAL
LIDOCAINE
AB WATSON LABS INC
LIDODERM
5% A200675 001 Aug 23, 2012
AB + TEIKOKU PHARMA USA 5% N020612 001 Mar 19, 1999
LIDOCAINE HYDROCHLORIDE
GEL;OPHTHALMIC
AKTEN
AKORN +
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE
3.5% N022221 001 Oct 07, 2008
AP
AP
AP
AP
AP
AP
AGILA SPECLTS
HOSPIRA
0.5%
0.5%
1%
1%
0.5%
1%
A091056 001 Dec 08, 2010
A091058 001 Sep 30, 2010
A091056 002 Dec 08, 2010
A091058 002 Sep 30, 2010
A088328 001 May 17, 1984
A083158 001
AP
AP
AP
1%
2%
2%
A088329 001 May 17, 1984
A040078 001 Jun 23, 1995
A083158 002
AP
AP
2%
20%
A088294 001 May 17, 1984
A083158 003
AP INTL MEDICATION 1% A083173 001
AP 2% A083173 002
AP LUITPOLD 1% A080850 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-216( of 362)
LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP
AP
B BRAUN 200MG/100ML
BAXTER HLTHCARE 200MG/100ML
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
N019830 002 Apr 08, 1992
N018461 002
AP
AP
B BRAUN 400MG/100ML
BAXTER HLTHCARE 400MG/100ML
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER
N019830 003 Apr 08, 1992
N018461 003
AP HOSPIRA 400MG/100ML
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
N018388 002
AP
AP
B BRAUN 800MG/100ML
BAXTER HLTHCARE 800MG/100ML
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER
N019830 004 Apr 08, 1992
N018461 004 Feb 22, 1982
AP HOSPIRA 800MG/100ML N018388 003 Nov 05, 1982
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
AP FRESENIUS KABI USA 1% A088586 001 Jul 24, 1985
AP HOSPIRA 0.5% A088325 001 Jul 31, 1984
AP 1% A088299 001 Jul 31, 1984
AP 2% A088327 001 Jul 31, 1984
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
AP AGILA SPECLTS 2% A090665 001 Sep 27, 2010
AP AUROBINDO PHARMA LTD 1% A203040 001 Mar 14, 2013
AP 1% A203082 001 Mar 14, 2013
AP 2% A203040 002 Mar 14, 2013
AP 2% A203082 002 Mar 14, 2013
AP FRESENIUS KABI USA 1% A080404 002
AP 2% A080404 003
AP 2% N017584 001
AP 4% N017584 002
AP HOSPIRA 1% A080408 001
AP 1.5% A080408 002
AP 4% A088295 001 May 17, 1984
AP INTL MEDICATION 20% N017702 001
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER
AP HOSPIRA 1% A040302 001 Sep 28, 1998
AP 2% A040302 002 Sep 28, 1998
LIDOPEN
AP MERIDIAN MEDCL TECHN 10% N017549 001
XYLOCAINE
AP + FRESENIUS KABI USA 0.5% N006488 008
AP + 1% N006488 007
AP + 1.5% N006488 010
AP + 2% N006488 002
XYLOCAINE 4% PRESERVATIVE FREE
AP + FRESENIUS KABI USA 4% N010417 001
XYLOCAINE PRESERVATIVE FREE
AP + FRESENIUS KABI USA 1% N016801 005 Jan 19, 1988
AP + 2% N016801 001
AP + 4% N016801 002
AP + 10% N016801 003
AP + 20% N016801 004
INJECTABLE;SPINAL
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%
+ HOSPIRA 5% A083914 001
JELLY;TOPICAL
LIDOCAINE HYDROCHLORIDE
AT AKORN 2% A040433 001 Feb 12, 2003
AT HI TECH PHARMA 2% A040837 001 Mar 23, 2011
AT INTL MEDICATION 2% A086283 001
XYLOCAINE
AT + OAK PHARMS 2% N008816 001
SOLUTION;ORAL
LIDOCAINE HYDROCHLORIDE
AT HI TECH PHARMA 2% A040014 001 Jul 10, 1995
AT WOCKHARDT 2% A087872 001 Nov 18, 1982
LIDOCAINE HYDROCHLORIDE VISCOUS
AT VINTAGE 2% A040708 001 Feb 27, 2007
LIDOCAINE VISCOUS
AT ROXANE 2% A088802 001 Apr 26, 1985
XYLOCAINE VISCOUS
AT + FRESENIUS KABI USA 2% N009470 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-217( of 362)
LIDOCAINE HYDROCHLORIDE
SOLUTION;TOPICAL
LARYNG-O-JET KIT
AT INTL MEDICATION 4% A086364 001
LIDOCAINE HYDROCHLORIDE
AT ROXANE 4% A088803 001 Apr 03, 1985
AT VINTAGE 4% A040710 001 Feb 27, 2007
AT WOCKHARDT 4% A087881 001 Nov 18, 1982
LTA II KIT
AT HOSPIRA 4% A080409 001
XYLOCAINE 4% PRESERVATIVE FREE
AT + FRESENIUS KABI USA 4% N010417 002
LIDOCAINE; PRILOCAINE
CREAM;TOPICAL
EMLA
AB + OAK PHARMS 2.5%;2.5% N019941 001 Dec 30, 1992
LIDOCAINE AND PRILOCAINE
AB FOUGERA PHARMS 2.5%;2.5% A076453 001 Aug 18, 2003
AB HI TECH PHARMA 2.5%;2.5% A076290 001 Sep 25, 2003
AB TOLMAR 2.5%;2.5% A076320 001 Aug 27, 2003
GEL;PERIODONTAL
ORAQIX
+ DENTSPLY PHARM 2.5%;2.5% N021451 001 Dec 19, 2003
LIDOCAINE; TETRACAINE
CREAM;TOPICAL
PLIAGLIS
+ GALDERMA LABS LP 7%;7% N021717 001 Jun 29, 2006
PATCH;TOPICAL
SYNERA
+ GALEN SPECIALTY 70MG;70MG N021623 001 Jun 23, 2005
LINACLOTIDE
CAPSULE;ORAL
LINZESS
FOREST LABS INC 145MCG N202811 001 Aug 30, 2012
+ 290MCG N202811 002 Aug 30, 2012
LINAGLIPTIN
TABLET;ORAL
TRADJENTA
+ BOEHRINGER INGELHEIM 5MG N201280 001 May 02, 2011
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
TABLET;ORAL
JENTADUETO
+ BOEHRINGER INGELHEIM 2.5MG;1GM N201281 003 Jan 30, 2012
2.5MG;500MG N201281 001 Jan 30, 2012
2.5MG;850MG N201281 002 Jan 30, 2012
LINCOMYCIN HYDROCHLORIDE
INJECTABLE;INJECTION
LINCOCIN
+ PHARMACIA AND UPJOHN EQ 300MG BASE/ML N050317 001
LINDANE
LOTION;TOPICAL
LINDANE
AT OLTA PHARMS 1% A087313 001
AT + WOCKHARDT 1% A088190 001 Aug 16, 1984
SHAMPOO;TOPICAL
LINDANE
AT OLTA PHARMS 1% A087266 001
AT + WOCKHARDT 1% A088191 001 Sep 18, 1984
LINEZOLID
FOR SUSPENSION;ORAL
ZYVOX
+ PHARMACIA AND UPJOHN 100MG/5ML N021132 001 Apr 18, 2000
INJECTABLE;INJECTION
LINEZOLID
AP TEVA PHARMS 200MG/100ML A200222 001 Jun 27, 2012
ZYVOX
AP + PHARMACIA AND UPJOHN 200MG/100ML N021131 001 Apr 18, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
LINEZOLID
TABLET;ORAL
ZYVOX
+ PHARMACIA AND UPJOHN
LIOTHYRONINE SODIUM
INJECTABLE;INJECTION
LIOTHYRONINE SODIUM
AP X GEN PHARMS
TRIOSTAT
AP + JHP PHARMS
TABLET;ORAL
CYTOMEL
AB KING PHARMS R AND D
AB
AB +
LIOTHYRONINE SODIUM
AB COASTAL PHARMS
AB
AB
AB MYLAN
AB
AB
AB SIGMAPHARM LABS LLC
AB
AB
LIOTRIX (T4;T3)
TABLET;ORAL
THYROLAR-0.25
FOREST LABS
THYROLAR-0.5
FOREST LABS
THYROLAR-1
FOREST LABS
THYROLAR-2
FOREST LABS
THYROLAR-3
+ FOREST LABS
LIRAGLUTIDE RECOMBINANT
SOLUTION;SUBCUTANEOUS
VICTOZA
+ NOVO NORDISK INC
LISDEXAMFETAMINE DIMESYLATE
CAPSULE;ORAL
VYVANSE
SHIRE DEVELOPMENT
+
LISINOPRIL
TABLET;ORAL
LISINOPRIL
AB ACCORD HLTHCARE
AB
AB
AB
AB
AB
AB APOTEX INC
AB
AB
AB
AB
AB
AB AUROBINDO
AB
AB
AB
AB
600MG
EQ 0.01MG BASE/ML
EQ 0.01MG BASE/ML
EQ 0.005MG BASE
EQ 0.025MG BASE
EQ 0.05MG BASE
EQ 0.005MG BASE
EQ 0.025MG BASE
EQ 0.05MG BASE
EQ 0.005MG BASE
EQ 0.025MG BASE
EQ 0.05MG BASE
EQ 0.005MG BASE
EQ 0.025MG BASE
EQ 0.05MG BASE
0.0031MG;0.0125MG
0.0063MG;0.025MG
0.0125MG;0.05MG
0.025MG;0.1MG
0.0375MG;0.15MG
18MG/3ML (6MG/ML)
20MG
30MG
40MG
50MG
60MG
70MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
3-218( of 362)
N021130 002 Apr 18, 2000
A076923 001 Aug 17, 2005
N020105 001 Dec 31, 1991
N010379 001
N010379 002
N010379 003
A090097 001 Mar 20, 2009
A090097 002 Mar 20, 2009
A090097 003 Mar 20, 2009
A090326 001 Jul 14, 2009
A090326 002 Jul 14, 2009
A090326 003 Jul 14, 2009
A200295 001 Nov 29, 2012
A200295 002 Nov 29, 2012
A200295 003 Nov 29, 2012
N016807 001
N016807 005
N016807 004
N016807 002
N016807 003
N022341 001 Jan 25, 2010
N021977 004 Dec 10, 2007
N021977 001 Feb 23, 2007
N021977 005 Dec 10, 2007
N021977 002 Feb 23, 2007
N021977 006 Dec 10, 2007
N021977 003 Feb 23, 2007
A202554 001 Jul 30, 2013
A202554 002 Jul 30, 2013
A202554 003 Jul 30, 2013
A202554 004 Jul 30, 2013
A202554 005 Jul 30, 2013
A202554 006 Jul 30, 2013
A076102 001 Sep 30, 2002
A076102 002 Sep 30, 2002
A076102 003 Sep 30, 2002
A076102 004 Sep 30, 2002
A076102 005 Sep 30, 2002
A076102 006 Sep 30, 2002
A077622 001 Feb 22, 2006
A077622 002 Feb 22, 2006
A077622 003 Feb 22, 2006
A077622 004 Feb 22, 2006
A077622 005 Feb 22, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
LISINOPRIL
TABLET;ORAL
LISINOPRIL
AB 40MG
AB HIKMA PHARMS 2.5MG
AB 5MG
AB 10MG
AB 20MG
AB 30MG
AB 40MG
AB INVAGEN PHARMS 2.5MG
AB 5MG
AB 10MG
AB 20MG
AB 30MG
AB 40MG
AB IVAX SUB TEVA PHARMS 2.5MG
AB 5MG
AB 10MG
AB 20MG
AB 30MG
AB 40MG
AB LUPIN 2.5MG
AB 5MG
AB 10MG
AB 20MG
AB 30MG
AB 40MG
AB MYLAN 2.5MG
AB 5MG
AB 10MG
AB 20MG
AB 30MG
AB 40MG
AB PRINSTON INC 2.5MG
AB 5MG
AB 10MG
AB 20MG
AB 30MG
AB 40MG
AB RANBAXY 2.5MG
AB 5MG
AB 10MG
AB 20MG
AB 30MG
AB 40MG
AB SANDOZ 2.5MG
AB 5MG
AB 10MG
AB 20MG
AB 30MG
AB 40MG
AB VINTAGE 2.5MG
AB 5MG
AB 10MG
AB 20MG
AB 30MG
AB 40MG
AB WATSON LABS 2.5MG
AB 5MG
AB 10MG
AB 20MG
AB 30MG
AB 40MG
AB WOCKHARDT 2.5MG
AB 5MG
AB 10MG
AB 20MG
AB 30MG
AB 40MG
PRINIVIL
AB MERCK 5MG
3-219( of 362)
A077622 006 Feb 22, 2006
A076063 001 Jul 01, 2002
A076063 002 Jul 01, 2002
A076063 003 Jul 01, 2002
A076063 004 Jul 01, 2002
A076063 006 Jun 27, 2003
A076063 005 Jul 01, 2002
A203508 001 Oct 29, 2013
A203508 002 Oct 29, 2013
A203508 003 Oct 29, 2013
A203508 004 Oct 29, 2013
A203508 005 Oct 29, 2013
A203508 006 Oct 29, 2013
A075752 001 Jul 01, 2002
A075752 002 Jul 01, 2002
A075752 003 Jul 01, 2002
A075752 004 Jul 01, 2002
A075752 005 Jul 01, 2002
A075752 006 Jul 01, 2002
A077321 001 Sep 09, 2005
A077321 002 Sep 09, 2005
A077321 003 Sep 09, 2005
A077321 004 Sep 09, 2005
A077321 005 Sep 09, 2005
A077321 006 Sep 09, 2005
A076071 001 Jul 01, 2002
A076071 002 Jul 01, 2002
A076071 003 Jul 01, 2002
A076071 004 Jul 01, 2002
A076071 005 Jul 01, 2002
A076071 006 Jul 01, 2002
A076180 001 Jul 01, 2002
A076180 002 Jul 01, 2002
A076180 003 Jul 01, 2002
A076164 001 Jul 01, 2002
A076164 002 Jul 01, 2002
A076164 003 Jul 01, 2002
A075944 001 Jul 01, 2002
A075944 002 Jul 01, 2002
A075944 003 Jul 01, 2002
A075944 004 Jul 01, 2002
A075944 006 Feb 11, 2003
A075944 005 Jul 01, 2002
A075994 001 Jul 01, 2002
A075994 002 Jul 01, 2002
A075994 003 Jul 01, 2002
A075994 004 Jul 01, 2002
A075994 005 Jul 01, 2002
A075994 006 Jul 01, 2002
A075743 001 Jul 01, 2002
A075743 002 Jul 01, 2002
A075743 003 Jul 01, 2002
A075743 004 Jul 01, 2002
A075743 005 Jul 01, 2002
A075743 006 Jul 01, 2002
A076059 001 Jul 01, 2002
A076059 002 Jul 01, 2002
A076059 003 Jul 01, 2002
A076059 004 Jul 01, 2002
A076059 005 Jul 01, 2002
A076059 006 Jul 01, 2002
A078402 001 Apr 19, 2007
A078402 002 Apr 19, 2007
A078402 003 Apr 19, 2007
A078402 004 Apr 19, 2007
A078402 005 Apr 19, 2007
A078402 006 Apr 19, 2007
N019558 001 Dec 29, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
LISINOPRIL
TABLET;ORAL
PRINIVIL
AB
AB
AB
ZESTRIL
AB ASTRAZENECA
AB
AB
AB
AB
AB +
LITHIUM CARBONATE
CAPSULE;ORAL
LITHIUM CARBONATE
AB ALEMBIC LTD
AB
AB
AB GLENMARK GENERICS
AB
AB
AB HETERO LABS LTD III
AB
AB
AB ROXANE
AB
AB +
AB WEST WARD
AB
TABLET;ORAL
LITHIUM CARBONATE
AB + ROXANE
AB SUN PHARM INDS INC
TABLET, EXTENDED RELEASE;ORAL
LITHIUM CARBONATE
AB GLENMARK GENERICS
AB
AB MYLAN PHARMS INC
AB
AB ROXANE
AB +
AB WEST WARD
LITHOBID
AB + NOVEN THERAP
LITHIUM CITRATE
SYRUP;ORAL
LITHIUM CITRATE
AA + ROXANE
AA WOCKHARDT
LODOXAMIDE TROMETHAMINE
SOLUTION/DROPS;OPHTHALMIC
ALOMIDE
+ ALCON
LOMITAPIDE MESYLATE
CAPSULE;ORAL
JUXTAPID
AEGERION
+
LOMUSTINE
CAPSULE;ORAL
CEENU
CORDEN PHARMA
+
10MG
20MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
300MG
300MG
300MG
450MG
300MG
450MG
300MG
450MG
450MG
300MG
EQ 300MG CARBONATE/5ML
EQ 300MG CARBONATE/5ML
EQ 0.1% BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE
10MG
40MG
100MG
3-220( of 362)
N019558 002 Dec 29, 1987
N019558 003 Dec 29, 1987
N019558 004 Oct 25, 1988
N019777 005 Apr 29, 1993
N019777 001 May 19, 1988
N019777 002 May 19, 1988
N019777 003 May 19, 1988
N019777 006 Jan 20, 1999
N019777 004 May 19, 1988
A079159 001 Jan 12, 2009
A079159 002 Jan 12, 2009
A079159 003 Jan 12, 2009
A079139 001 Feb 03, 2009
A079139 002 Feb 03, 2009
A079139 003 Feb 03, 2009
A090702 001 Sep 25, 2009
A090702 002 Sep 25, 2009
A090702 003 Sep 25, 2009
N017812 002 Jan 28, 1987
N017812 001
N017812 003 Jan 28, 1987
A076243 002 Feb 24, 2003
A076243 001 Jun 27, 2002
N018558 001 Jan 29, 1982
A091027 001 Jun 24, 2010
A091544 001 Dec 27, 2010
A091616 001 Feb 14, 2011
A202288 001 Jun 29, 2012
A202219 001 Aug 08, 2012
A076832 001 Oct 28, 2004
A076691 001 Jan 05, 2004
A076490 001 Jun 17, 2003
N018027 001
N018421 001
A070755 001 May 21, 1986
N020191 001 Sep 23, 1993
N203858 001 Dec 21, 2012
N203858 002 Dec 21, 2012
N203858 003 Dec 21, 2012
N017588 001
N017588 002
N017588 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-221( of 362)
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
IMODIUM
AB + MCNEIL CONS 2MG N017694 001
LOPERAMIDE HYDROCHLORIDE
AB MYLAN 2MG A072741 001 Sep 18, 1991
AB TEVA 2MG A073192 001 Apr 30, 1992
LOPINAVIR; RITONAVIR
CAPSULE;ORAL
KALETRA
+ ABBVIE 133.3MG;33.3MG N021226 001 Sep 15, 2000
SOLUTION;ORAL
KALETRA
+ ABBVIE 80MG/ML;20MG/ML N021251 001 Sep 15, 2000
TABLET;ORAL
KALETRA
ABBVIE 100MG;25MG N021906 002 Nov 09, 2007
+ 200MG;50MG N021906 001 Oct 28, 2005
LORAZEPAM
CONCENTRATE;ORAL
LORAZEPAM
AA AMNEAL PHARMS 2MG/ML A091383 001 Dec 23, 2009
AA HI-TECH PHARMA CO 2MG/ML A200169 001 Jan 30, 2012
AA LUPIN LTD 2MG/ML A091407 001 Feb 19, 2013
AA PADDOCK LLC 2MG/ML A079244 001 Apr 28, 2009
AA PHARM ASSOC 2MG/ML A090260 001 Jun 15, 2010
LORAZEPAM INTENSOL
AA + ROXANE 2MG/ML A072755 001 Jun 28, 1991
INJECTABLE;INJECTION
ATIVAN
AP + BAXTER HLTHCARE CORP 2MG/ML N018140 001
AP + 4MG/ML N018140 002
LORAZEPAM
AP AKORN 2MG/ML A075025 001 Jul 23, 1998
AP HOSPIRA 2MG/ML A074243 001 Apr 12, 1994
AP 2MG/ML A074282 001 May 27, 1994
AP 4MG/ML A074243 002 Apr 12, 1994
AP 4MG/ML A074282 002 May 27, 1994
AP INTL MEDICATION SYS 2MG/ML A076150 001 Nov 15, 2004
LORAZEPAM PRESERVATIVE FREE
AP BEDFORD LABS 2MG/ML A077074 001 Jul 13, 2005
AP 4MG/ML A077074 002 Jul 13, 2005
TABLET;ORAL
ATIVAN
AB VALEANT INTL 0.5MG N017794 001
AB 1MG N017794 002
AB + 2MG N017794 003
LORAZEPAM
AB AMNEAL PHARMS 0.5MG A078826 001 Jun 23, 2010
AB 1MG A078826 002 Jun 23, 2010
AB 2MG A078826 003 Jun 23, 2010
AB EXCELLIUM 0.5MG A078203 001 Jul 30, 2007
AB 1MG A078203 002 Jul 30, 2007
AB 2MG A078203 003 Jul 30, 2007
AB IVAX SUB TEVA PHARMS 0.5MG A077396 001 Dec 13, 2006
AB 1MG A077396 002 Dec 13, 2006
AB 2MG A077396 003 Dec 13, 2006
AB MYLAN 0.5MG A071589 001 Oct 13, 1987
AB 0.5MG A077657 001 Mar 16, 2006
AB 1MG A071590 001 Oct 13, 1987
AB 1MG A077657 002 Mar 16, 2006
AB 2MG A071591 001 Oct 13, 1987
AB 2MG A077657 003 Mar 16, 2006
AB RANBAXY 0.5MG A076045 001 Aug 29, 2001
AB 1MG A076045 002 Aug 29, 2001
AB 2MG A076045 003 Aug 29, 2001
AB SANDOZ 0.5MG A071403 001 Apr 21, 1987
AB 1MG A071404 001 Apr 21, 1987
AB 2MG A071141 001 Apr 21, 1987
AB VINTAGE PHARMS 0.5MG A077754 001 May 10, 2006
AB 1MG A077754 002 May 10, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
LORAZEPAM
TABLET;ORAL
LORAZEPAM
AB
AB WATSON LABS
AB
AB
AB
LORCASERIN HYDROCHLORIDE
TABLET;ORAL
BELVIQ
+ EISAI INC
LOSARTAN POTASSIUM
TABLET;ORAL
COZAAR
AB MERCK SHARP DOHME
AB
AB +
LOSARTAN POTASSIUM
AB ALEMBIC PHARMS LTD
AB
AB
AB APOTEX CORP
AB
AB
AB AUROBINDO PHARMA
AB
AB
AB CADISTA PHARMS
AB
AB
AB IPCA LABS LTD
AB
AB
AB LUPIN LTD
AB
AB
AB MACLEODS PHARMS LTD
AB
AB
AB MICRO LABS LTD INDIA
AB
AB
AB MYLAN
AB
AB
AB PRINSTON INC
AB
AB
AB ROXANE
AB
AB
AB SANDOZ
AB
AB
AB TEVA
AB
AB
AB TORRENT PHARMS
AB
AB
AB UPSHER SMITH
AB
AB
AB VIVIMED LABS
AB
AB
AB WATSON LABS
AB
AB
AB ZYDUS PHARMS USA INC
2MG
0.5MG
1MG
1MG
2MG
10MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
3-222( of 362)
A077754 003 May 10, 2006
A072926 001 Oct 31, 1991
A071118 001 Jul 24, 1986
A072927 001 Oct 31, 1991
A072928 001 Oct 31, 1991
N022529 001 Jun 27, 2012
N020386 001 Apr 14, 1995
N020386 002 Apr 14, 1995
N020386 003 Oct 13, 1998
A090428 001 Oct 06, 2010
A090428 002 Oct 06, 2010
A090428 003 Oct 06, 2010
A090790 001 Oct 06, 2010
A090790 002 Oct 06, 2010
A090790 003 Oct 06, 2010
A090083 001 Oct 06, 2010
A090083 002 Oct 06, 2010
A090083 003 Oct 06, 2010
A201170 001 Sep 18, 2012
A201170 002 Sep 18, 2012
A201170 003 Sep 18, 2012
A200290 001 Aug 30, 2013
A200290 002 Aug 30, 2013
A200290 003 Aug 30, 2013
A078232 001 Oct 06, 2010
A078232 002 Oct 06, 2010
A078232 003 Oct 06, 2010
A202230 001 May 30, 2012
A202230 002 May 30, 2012
A202230 003 May 30, 2012
A091541 001 Sep 24, 2012
A091541 002 Sep 24, 2012
A091541 003 Sep 24, 2012
A091590 001 Oct 06, 2010
A091590 002 Oct 06, 2010
A091590 003 Oct 06, 2010
A091497 001 Jun 06, 2011
A091497 002 Jun 06, 2011
A091497 003 Jun 06, 2011
A077459 001 Oct 06, 2010
A077459 002 Oct 06, 2010
A077459 003 Oct 06, 2010
A077424 001 Oct 06, 2010
A077424 002 Oct 06, 2010
A077424 003 Oct 06, 2010
A076958 001 Apr 06, 2010
A076958 002 Apr 06, 2010
A076958 003 Apr 06, 2010
A090467 001 Oct 06, 2010
A090467 002 Oct 06, 2010
A090467 003 Oct 06, 2010
A090544 001 Oct 06, 2010
A090544 002 Oct 06, 2010
A090544 003 Oct 06, 2010
A090382 001 Oct 06, 2010
A090382 002 Oct 06, 2010
A090382 003 Oct 06, 2010
A091129 001 Oct 06, 2010
A091129 002 Oct 06, 2010
A091129 003 Oct 06, 2010
A078243 001 Oct 06, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-223( of 362)
LOSARTAN POTASSIUM
TABLET;ORAL
LOSARTAN POTASSIUM
AB 50MG A078243 002 Oct 06, 2010
AB 100MG A078243 003 Oct 06, 2010
LOTEPREDNOL ETABONATE
GEL;OPHTHALMIC
LOTEMAX
+ BAUSCH AND LOMB 0.5% N202872 001 Sep 28, 2012
OINTMENT;OPHTHALMIC
LOTEMAX
+ BAUSCH AND LOMB 0.5% N200738 001 Apr 15, 2011
SUSPENSION/DROPS;OPHTHALMIC
ALREX
+ BAUSCH AND LOMB 0.2% N020803 001 Mar 09, 1998
LOTEMAX
+ BAUSCH AND LOMB 0.5% N020583 001 Mar 09, 1998
LOTEPREDNOL ETABONATE; TOBRAMYCIN
SUSPENSION/DROPS;OPHTHALMIC
ZYLET
+ BAUSCH AND LOMB 0.5%;0.3% N050804 001 Dec 14, 2004
LOVASTATIN
TABLET;ORAL
LOVASTATIN
AB ACTAVIS ELIZABETH 10MG A075828 001 Dec 17, 2001
AB 20MG A075828 002 Dec 17, 2001
AB 40MG A075828 003 Dec 17, 2001
AB APOTEX INC 10MG A077748 001 Feb 28, 2007
AB 20MG A077748 002 Feb 28, 2007
AB 40MG A077748 003 Feb 28, 2007
AB CARLSBAD 10MG A075991 001 Jun 05, 2002
AB 20MG A075991 002 Jun 05, 2002
AB + 40MG A075991 003 Jun 05, 2002
AB LUPIN 10MG A078296 001 Mar 14, 2008
AB 20MG A078296 002 Nov 01, 2007
AB 40MG A078296 003 Nov 01, 2007
AB MUTUAL PHARM 10MG A077520 001 Apr 14, 2006
AB 20MG A077520 002 Apr 14, 2006
AB 40MG A077520 003 Apr 14, 2006
AB MYLAN 10MG A075451 001 Dec 17, 2001
AB 10MG A075935 001 Dec 17, 2001
AB 20MG A075451 002 Dec 17, 2001
AB 20MG A075935 002 Dec 17, 2001
AB 40MG A075451 003 Dec 17, 2001
AB 40MG A075935 003 Dec 17, 2001
AB SANDOZ 10MG A075300 001 Dec 17, 2001
AB 10MG A075636 001 Dec 17, 2001
AB 20MG A075300 002 Dec 17, 2001
AB 20MG A075636 002 Dec 17, 2001
AB 40MG A075300 003 Dec 17, 2001
AB 40MG A075636 003 Dec 17, 2001
AB TEVA 10MG A075551 003 Dec 17, 2001
AB 20MG A075551 002 Dec 17, 2001
AB 40MG A075551 001 Dec 17, 2001
TABLET, EXTENDED RELEASE;ORAL
ALTOPREV
ANDRX LABS LLC 20MG N021316 002 Jun 26, 2002
40MG N021316 003 Jun 26, 2002
+ 60MG N021316 004 Jun 26, 2002
LOVASTATIN; NIACIN
TABLET, EXTENDED RELEASE;ORAL
ADVICOR
+ ABBVIE 20MG;1GM N021249 003 Dec 17, 2001
+ 20MG;500MG N021249 001 Dec 17, 2001
+ 20MG;750MG N021249 002 Dec 17, 2001
+ 40MG;1GM N021249 004 Apr 27, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
LOXAPINE
POWDER;INHALATION
ADASUVE
+ TEVA PHARMS USA INC
LOXAPINE SUCCINATE
CAPSULE;ORAL
LOXAPINE SUCCINATE
AB LANNETT HOLDINGS INC
AB
AB
AB
AB MIKAH PHARMA
AB
AB
AB
AB MYLAN
AB
AB
AB
AB WATSON LABS
AB
AB +
AB
LUBIPROSTONE
CAPSULE;ORAL
AMITIZA
SUCAMPO PHARMS
+
LUCINACTANT
SUSPENSION;INTRATRACHEAL
SURFAXIN
+ DISCOVERY LABS
LULICONAZOLE
CREAM;TOPICAL
LUZU
MEDICIS
LURASIDONE HYDROCHLORIDE
TABLET;ORAL
LATUDA
SUNOVION PHARMS INC
+
MACITENTAN
TABLET;ORAL
OPSUMIT
+ ACTELION PHARMS LTD
MAFENIDE ACETATE
CREAM;TOPICAL
SULFAMYLON
+ MYLAN INSTITUTIONAL
FOR SOLUTION;TOPICAL
MAFENIDE ACETATE
AB PAR FORM
SULFAMYLON
AB + MYLAN INSTITUTIONAL
10MG
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
8MCG
24MCG
8.5ML
1%
20MG
40MG
60MG
80MG
120MG
10MG
EQ 85MG BASE/GM
5%
5%
MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
PLASMA-LYTE 56 IN PLASTIC CONTAINER
BAXTER HLTHCARE 32MG/100ML;128MG/100ML;234MG/100ML
3-224( of 362)
N022549 001 Dec 21, 2012
A090695 001 Sep 26, 2011
A090695 002 Sep 26, 2011
A090695 003 Sep 26, 2011
A090695 004 Sep 26, 2011
A076868 001 Aug 04, 2005
A076868 002 Aug 04, 2005
A076868 003 Aug 04, 2005
A076868 004 Aug 04, 2005
A076762 001 Nov 01, 2004
A076762 002 Nov 01, 2004
A076762 003 Nov 01, 2004
A076762 004 Nov 01, 2004
A072204 001 Jun 15, 1988
A072205 001 Jun 15, 1988
A072206 001 Jun 15, 1988
A072062 001 Jun 15, 1988
N021908 002 Apr 29, 2008
N021908 001 Jan 31, 2006
N021746 001 Mar 06, 2012
N204153 001 Nov 14, 2013
N200603 003 Dec 07, 2011
N200603 001 Oct 28, 2010
N200603 005 Jul 12, 2013
N200603 002 Oct 28, 2010
N200603 004 Apr 26, 2012
N204410 001 Oct 18, 2013
N016763 001
A201511 001 Feb 12, 2013
N019832 003 Jun 05, 1998
N019047 001 Jun 15, 1984
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM
CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE;INJECTION
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER
+ B BRAUN 30MG/100ML;37MG/100ML;0.82MG/100ML;370M N019696 001 Sep 29, 1989
G/100ML;530MG/100ML;500MG/100ML;12MG/10
0ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-225( of 362)
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
INJECTABLE;INJECTION
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N017378 001
/100ML;502MG/100ML
PLASMA-LYTE A IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N017378 002 Nov 22, 1982
/100ML;502MG/100ML
ISOLYTE S IN PLASTIC CONTAINER
B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N019711 001 Sep 29, 1989
/100ML;500MG/100ML
NORMOSOL-R IN PLASTIC CONTAINER
HOSPIRA 30MG/100ML;37MG/100ML;222MG/100ML;526MG N017586 001
/100ML;502MG/100ML
SOLUTION;IRRIGATION
PHYSIOLYTE IN PLASTIC CONTAINER
B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N019024 001 Jun 08, 1984
/100ML;500MG/100ML
PHYSIOSOL IN PLASTIC CONTAINER
HOSPIRA 30MG/100ML;37MG/100ML;222MG/100ML;526MG N017637 002 Jul 08, 1982
/100ML;502MG/100ML
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
SOLUTION;INJECTION
NORMOCARB HF 25
+ DIALYSIS SUPS 0.21GM/100ML;2.8GM/100ML;9.07GM/100ML N021910 001 Jul 26, 2006
NORMOCARB HF 35
+ DIALYSIS SUPS 0.21GM/100ML;3.97GM/100ML;8.3GM/100ML N021910 002 Jul 26, 2006
MAGNESIUM SULFATE
INJECTABLE;INJECTION
MAGNESIUM SULFATE
AP + FRESENIUS KABI USA 500MG/ML N019316 001 Sep 08, 1986
AP HOSPIRA 500MG/ML A075151 001 Apr 25, 2000
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
+ HOSPIRA 1GM/100ML N020488 001 Jul 11, 1995
+ 2GM/100ML N020488 002 Jul 11, 1995
MAGNESIUM SULFATE IN PLASTIC CONTAINER
HOSPIRA 2GM/50ML (40MG/ML) N020309 003 Jan 26, 2007
+ 4GM/100ML (40MG/ML) N020309 001 Jun 24, 1994
+ 4GM/50ML (80MG/ML) N020309 002 Jun 24, 1994
20GM/500ML (40MG/ML) N020309 004 Jan 18, 1995
40GM/1000ML(40MG/ML) N020309 005 Jan 18, 1995
MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE
SOLUTION;ORAL
SUPREP BOWEL PREP KIT
+ BRAINTREE LABS 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT N022372 001 Aug 05, 2010
MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM
BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
SOLUTION;ORAL
SUCLEAR
+ BRAINTREE LABS 1.6GM;210GM;0.74GM;3.13GM;2.86GM;5.6GM; N203595 001 Jan 18, 2013
17.5GM
MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM
PHOSPHATE
SOLUTION;IRRIGATION
TIS-U-SOL
AT BAXTER HLTHCARE 20MG/100ML;40MG/100ML;6.25MG/100ML;800M N018508 001 Feb 19, 1982
G/100ML;8.75MG/100ML
TIS-U-SOL IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 20MG/100ML;40MG/100ML;6.25MG/100ML;800M N018336 001
G/100ML;8.75MG/100ML
MALATHION
LOTION;TOPICAL
MALATHION
AT MYLAN PHARMS INC 0.5% A078743 001 Mar 06, 2009
AT SUVEN LIFE 0.5% A091559 001 May 23, 2012
OVIDE
AT + TARO PHARMS NORTH 0.5% N018613 001 Aug 02, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-226( of 362)
MANGANESE CHLORIDE
INJECTABLE;INJECTION
MANGANESE CHLORIDE IN PLASTIC CONTAINER
HOSPIRA EQ 0.1MG MANGANESE/ML N018962 001 Jun 26, 1986
MANNITOL
INJECTABLE;INJECTION
MANNITOL 10%
AP B BRAUN 10GM/100ML N016080 002
MANNITOL 10% IN PLASTIC CONTAINER
AP B BRAUN 10GM/100ML N020006 002 Jul 26, 1993
AP HOSPIRA 10GM/100ML N019603 002 Jan 08, 1987
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER
AP B BRAUN 10GM/100ML N016080 006
MANNITOL 15%
AP B BRAUN 15GM/100ML N016080 003
MANNITOL 15% IN PLASTIC CONTAINER
AP B BRAUN 15GM/100ML N020006 003 Jul 26, 1993
AP HOSPIRA 15GM/100ML N019603 003 Jan 08, 1990
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
AP B BRAUN 15GM/100ML N016080 005
MANNITOL 20%
AP B BRAUN 20GM/100ML N016080 004
MANNITOL 20% IN PLASTIC CONTAINER
AP B BRAUN 20GM/100ML N020006 004 Jul 26, 1993
AP HOSPIRA 20GM/100ML N019603 004 Jan 08, 1990
MANNITOL 25%
AP FRESENIUS KABI USA 12.5GM/50ML A080677 001
AP HOSPIRA 12.5GM/50ML N016269 006 Aug 25, 1994
AP INTL MEDICATION 12.5GM/50ML A083051 001
AP LUITPOLD 12.5GM/50ML A087409 001 Jan 21, 1982
MANNITOL 5%
AP B BRAUN 5GM/100ML N016080 001
MANNITOL 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML N020006 001 Jul 26, 1993
AP HOSPIRA 5GM/100ML N019603 001 Jan 08, 1987
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%
AP B BRAUN 5GM/100ML N016080 007
OSMITROL 10% IN WATER
AP BAXTER HLTHCARE 10GM/100ML N013684 002
OSMITROL 10% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 10GM/100ML N013684 006
OSMITROL 15% IN WATER
AP BAXTER HLTHCARE 15GM/100ML N013684 004
OSMITROL 15% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 15GM/100ML N013684 008
OSMITROL 20% IN WATER
AP BAXTER HLTHCARE 20GM/100ML N013684 003
OSMITROL 20% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20GM/100ML N013684 007
OSMITROL 5% IN WATER
AP BAXTER HLTHCARE 5GM/100ML N013684 001
OSMITROL 5% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML N013684 005
POWDER;INHALATION
ARIDOL KIT
+ PHARMAXIS LTD N/A,5MG,10MG,20MG,40MG N022368 001 Oct 05, 2010
SOLUTION;IRRIGATION
RESECTISOL IN PLASTIC CONTAINER
B BRAUN 5GM/100ML N016772 002
MANNITOL; SORBITOL
SOLUTION;IRRIGATION
SORBITOL-MANNITOL IN PLASTIC CONTAINER
HOSPIRA 540MG/100ML;2.7GM/100ML N018316 001
MAPROTILINE HYDROCHLORIDE
TABLET;ORAL
MAPROTILINE HYDROCHLORIDE
MYLAN 25MG A072285 002 Oct 03, 1988
+ 50MG A072285 001 Oct 03, 1988
75MG A072285 003 Oct 03, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-227( of 362)
MARAVIROC
TABLET;ORAL
SELZENTRY
VIIV HLTHCARE 150MG N022128 001 Aug 06, 2007
+ 300MG N022128 002 Aug 06, 2007
MEBENDAZOLE
TABLET, CHEWABLE;ORAL
MEBENDAZOLE
+ TEVA PHARMS 100MG A073580 001 Jan 04, 1995
MECAMYLAMINE HYDROCHLORIDE
TABLET;ORAL
MECAMYLAMINE HYDROCHLORIDE
NEXGEN PHARMA 2.5MG A204054 001 Mar 19, 2013
MECASERMIN RECOMBINANT
INJECTABLE;SUBCUTANEOUS
INCRELEX
+ IPSEN INC 40MG/4ML (10MG/ML) N021839 001 Aug 30, 2005
MECHLORETHAMINE HYDROCHLORIDE
GEL;TOPICAL
VALCHLOR
+ ACTELION PHARMS LTD 0.02% N202317 001 Aug 23, 2013
INJECTABLE;INJECTION
MUSTARGEN
+ RECORDATI RARE 10MG/VIAL N006695 001
MECLIZINE HYDROCHLORIDE
TABLET;ORAL
ANTIVERT
AA + CITRON PHARMA LLC 12.5MG N010721 006
AA + 25MG N010721 004
AA + 50MG N010721 001 Jan 20, 1982
MECLIZINE HYDROCHLORIDE
AA AMNEAL PHARMS 12.5MG A201451 001 Feb 23, 2011
AA 25MG A201451 002 Feb 23, 2011
AA 50MG A201451 003 Feb 23, 2011
AA EPIC PHARMA LLC 12.5MG A200294 001 Apr 13, 2012
AA 25MG A200294 002 Apr 13, 2012
AA JUBILANT CADISTA 12.5MG A040659 001 Jun 04, 2010
AA 25MG A040659 002 Jun 04, 2010
AA MYLAN PHARMS INC 12.5MG A202640 001 Sep 17, 2012
AA 25MG A202640 002 Sep 17, 2012
AA 50MG A202640 003 Sep 17, 2012
AA PAR PHARM 12.5MG A087127 001
AA 25MG A087128 001
AA 50MG A089674 001 Mar 31, 1988
AA SANDOZ 12.5MG A084843 002 May 22, 1989
AA 25MG A084092 003 May 22, 1989
AA VINTAGE PHARMS 12.5MG A040179 001 Jan 30, 1997
AA 25MG A040179 002 Jan 30, 1997
AA WATSON LABS 25MG A085740 001
MECLOFENAMATE SODIUM
CAPSULE;ORAL
MECLOFENAMATE SODIUM
MYLAN EQ 50MG BASE A071081 002 Sep 03, 1986
+ EQ 100MG BASE A071081 001 Sep 03, 1986
MEDROXYPROGESTERONE ACETATE
INJECTABLE;INJECTION
DEPO-PROVERA
AB + PHARMACIA AND UPJOHN 150MG/ML N020246 001 Oct 29, 1992
MEDROXYPROGESTERONE ACETATE
AB SANDOZ 150MG/ML A078711 001 May 20, 2009
AB TEVA PHARMS USA 150MG/ML A076553 001 Jul 28, 2004
DEPO-PROVERA
+ PHARMACIA AND UPJOHN 400MG/ML N012541 003
INJECTABLE;SUBCUTANEOUS
DEPO-SUBQ PROVERA 104
+ PHARMACIA AND UPJOHN 104MG/0.65ML N021583 001 Dec 17, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-228( of 362)
MEDROXYPROGESTERONE ACETATE
TABLET;ORAL
MEDROXYPROGESTERONE ACETATE
AB BARR 2.5MG A040159 001 Aug 09, 1996
AB 5MG A040159 002 Aug 09, 1996
AB 10MG A040159 003 Aug 09, 1996
PROVERA
AB PHARMACIA AND UPJOHN 2.5MG N011839 001
AB 5MG N011839 003
AB + 10MG N011839 004
MEDROXYPROGESTERONE ACETATE
BP USL PHARMA 10MG A088484 001 Jul 26, 1984
MEFENAMIC ACID
CAPSULE;ORAL
MEFENAMIC ACID
AB BRECKENRIDGE PHARM 250MG A090359 001 Feb 05, 2013
AB LUPIN LTD 250MG A091322 001 Jul 22, 2011
AB MICRO LABS LTD 250MG A090562 001 Nov 19, 2010
PONSTEL
AB + SHIONOGI INC 250MG N015034 003
MEFLOQUINE HYDROCHLORIDE
TABLET;ORAL
MEFLOQUINE HYDROCHLORIDE
AB BARR 250MG A076392 001 Dec 29, 2003
AB ROXANE 250MG A076523 001 Oct 01, 2004
AB + SANDOZ 250MG A076175 001 Feb 20, 2002
MEGESTROL ACETATE
SUSPENSION;ORAL
MEGACE
AB + BRISTOL MYERS SQUIBB 40MG/ML N020264 001 Sep 10, 1993
MEGESTROL ACETATE
AB PAR PHARM 40MG/ML A075671 001 Jul 25, 2001
AB ROXANE 40MG/ML A075997 001 Feb 15, 2002
AB TEVA PHARMS 40MG/ML A075681 001 May 05, 2003
AB WOCKHARDT 40MG/ML A076721 001 Nov 01, 2004
MEGACE ES
+ PAR PHARM 125MG/ML N021778 001 Jul 05, 2005
TABLET;ORAL
MEGESTROL ACETATE
AB BARR 20MG A074621 002 Aug 16, 1996
AB 40MG A074621 001 Nov 30, 1995
AB PAR PHARM 20MG A072422 001 Aug 08, 1988
AB + 40MG A072423 001 Aug 08, 1988
AB ROXANE 20MG A074458 001 Sep 29, 1995
AB 40MG A074458 002 Sep 29, 1995
MELOXICAM
SUSPENSION;ORAL
MOBIC
+ BOEHRINGER INGELHEIM 7.5MG/5ML N021530 001 Jun 01, 2004
TABLET;ORAL
MELOXICAM
AB APOTEX INC 7.5MG A077882 001 Jul 20, 2006
AB 15MG A077882 002 Jul 20, 2006
AB AUROBINDO PHARMA 7.5MG A078008 001 Oct 02, 2006
AB 15MG A078008 002 Oct 02, 2006
AB BRECKENRIDGE PHARM 7.5MG A077920 001 Jul 19, 2006
AB 15MG A077920 002 Jul 19, 2006
AB CARACO 7.5MG A077937 001 Jul 19, 2006
AB 15MG A077937 002 Jul 19, 2006
AB CARLSBAD 7.5MG A077918 001 Dec 07, 2006
AB 15MG A077918 002 Dec 07, 2006
AB CIPLA LTD 7.5MG A077929 001 Jul 19, 2006
AB 15MG A077929 002 Jul 19, 2006
AB DR REDDYS LABS INC 7.5MG A077931 001 Jul 25, 2006
AB 15MG A077931 002 Jul 25, 2006
AB GLENMARK GENERICS 7.5MG A077932 001 Jul 19, 2006
AB 15MG A077932 002 Jul 19, 2006
AB LUPIN PHARMS 7.5MG A077944 001 Jul 19, 2006
AB 15MG A077944 002 Jul 19, 2006
AB MYLAN 7.5MG A077923 001 Jul 19, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-229( of 362)
MELOXICAM
TABLET;ORAL
MELOXICAM
AB 15MG A077923 002 Jul 19, 2006
AB PURACAP PHARM 7.5MG A077938 001 Jul 19, 2006
AB 15MG A077938 002 Jul 19, 2006
AB STRIDES ARCOLAB LTD 7.5MG A077928 001 May 13, 2009
AB 15MG A077928 002 May 13, 2009
AB TARO 7.5MG A078102 001 Nov 07, 2006
AB 15MG A078102 002 Nov 07, 2006
AB TEVA PHARMS 7.5MG A077936 001 Jul 19, 2006
AB 15MG A077936 002 Jul 19, 2006
AB UNICHEM 7.5MG A077927 001 Dec 20, 2006
AB 15MG A077927 002 Dec 20, 2006
AB ZYDUS PHARMS USA 7.5MG A077921 001 Jul 19, 2006
AB 15MG A077921 002 Jul 19, 2006
MOBIC
AB BOEHRINGER INGELHEIM 7.5MG N020938 001 Apr 13, 2000
AB + 15MG N020938 002 Aug 23, 2000
MELPHALAN
TABLET;ORAL
ALKERAN
+ GLAXOSMITHKLINE 2MG N014691 002
MELPHALAN HYDROCHLORIDE
INJECTABLE;INJECTION
ALKERAN
AP + GLAXOSMITHKLINE EQ 50MG BASE/VIAL N020207 001 Nov 18, 1992
MELPHALAN HYDROCHLORIDE
AP BEDFORD LABS EQ 50MG BASE/VIAL A090303 001 Oct 28, 2010
AP MYLAN INSTITUTIONAL EQ 50MG BASE/VIAL A090270 001 Jun 09, 2009
MEMANTINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
NAMENDA XR
FOREST LABS 7MG N022525 001 Jun 21, 2010
14MG N022525 002 Jun 21, 2010
21MG N022525 003 Jun 21, 2010
+ 28MG N022525 004 Jun 21, 2010
SOLUTION;ORAL
NAMENDA
+ FOREST LABS 2MG/ML N021627 001 Apr 18, 2005
TABLET;ORAL
NAMENDA
FOREST LABS 5MG N021487 001 Oct 16, 2003
+ 10MG N021487 002 Oct 16, 2003
MENOTROPINS (FSH;LH)
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
REPRONEX
+ FERRING 75 IU/VIAL;75 IU/VIAL N021047 001 Aug 27, 1999
INJECTABLE;SUBCUTANEOUS
MENOPUR
+ FERRING 75 IU/VIAL;75 IU/VIAL N021663 001 Oct 29, 2004
MEPENZOLATE BROMIDE
TABLET;ORAL
CANTIL
+ SANOFI AVENTIS US 25MG N010679 003
MEPERIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
DEMEROL
AP + HOSPIRA 25MG/ML N021171 001
AP + 50MG/ML N021171 002
AP + 75MG/ML N021171 003
AP + 100MG/ML N021171 004
MEPERIDINE HYDROCHLORIDE
AP HIKMA MAPLE 25MG/ML A080445 001
AP 25MG/ML A080455 007
AP 50MG/ML A080445 002
AP 50MG/ML A080455 008
AP 75MG/ML A080445 003
AP 75MG/ML A080455 009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-230( of 362)
MEPERIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
MEPERIDINE HYDROCHLORIDE
AP 100MG/ML A080445 004
AP 100MG/ML A080455 010
AP WATSON LABS 50MG/ML A073444 001 Mar 17, 1992
AP 100MG/ML A073445 001 Mar 17, 1992
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
AP HIKMA MAPLE 10MG/ML A081002 001 Jul 30, 1993
AP + HOSPIRA 10MG/ML A088432 001 Aug 16, 1984
AP INTL MEDICATION 10MG/ML A081309 001 Aug 30, 1993
AP WATSON LABS 10MG/ML A073443 001 Mar 17, 1992
SYRUP;ORAL
MEPERIDINE HYDROCHLORIDE
+ ROXANE 50MG/5ML A088744 001 Jan 30, 1985
TABLET;ORAL
DEMEROL
AA + SANOFI AVENTIS US 50MG N005010 001
AA + 100MG N005010 004
MEPERIDINE HYDROCHLORIDE
AA BARR 50MG A088639 001 Jul 02, 1984
AA 100MG A088640 001 Sep 19, 1984
AA CARACO 50MG A040446 001 Aug 08, 2002
AA 100MG A040446 002 Aug 08, 2002
AA EPIC PHARMA 50MG A040331 001 May 28, 1999
AA 100MG A040331 002 May 28, 1999
AA MALLINCKRODT 50MG A040352 001 Jun 13, 2000
AA 100MG A040352 002 Jun 13, 2000
AA MIKART 50MG A040893 001 Jun 24, 2009
AA 100MG A040893 003 Jun 24, 2009
AA ROXANE 50MG A040110 001 Mar 12, 1997
AA 100MG A040110 002 Mar 12, 1997
AA VINTAGE PHARMS 50MG A040191 001 Dec 17, 1998
AA 100MG A040191 002 Dec 17, 1998
AA WATSON LABS 50MG A040186 001 Jun 30, 1997
AA 100MG A040186 002 Jun 30, 1997
MIKART 75MG A040893 002 Jun 24, 2009
150MG A040893 004 Jun 24, 2009
MEPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CARBOCAINE
AP + HOSPIRA 1% N012250 001
AP + 1.5% N012250 005
AP + 2% N012250 002
ISOCAINE HYDROCHLORIDE
AP + NOVOCOL 3% A080925 001
MEPIVACAINE HYDROCHLORIDE
AP HOSPIRA INC 3% A040806 001 Apr 28, 2008
AP WATSON LABS 1% A088769 001 Nov 20, 1984
AP 2% A088770 001 Nov 20, 1984
POLOCAINE
AP FRESENIUS KABI USA 1% A089407 001 Dec 01, 1986
AP 2% A089410 001 Dec 01, 1986
POLOCAINE-MPF
AP FRESENIUS KABI USA 1% A089406 001 Dec 01, 1986
AP 1.5% A089408 001 Dec 01, 1986
AP 2% A089409 001 Dec 01, 1986
SCANDONEST PLAIN
AP + DEPROCO 3% A088387 001 Oct 10, 1984
MEPROBAMATE
TABLET;ORAL
MEPROBAMATE
AA ALEMBIC PHARMS LTD 200MG A090122 001 Feb 18, 2009
AA 400MG A090122 002 Feb 18, 2009
AA INVAGEN PHARMS 200MG A040797 001 Feb 27, 2008
AA 400MG A040797 002 Feb 27, 2008
AA + WATSON LABS 200MG A083304 001
AA + 400MG A083308 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-231( of 362)
MERCAPTOPURINE
TABLET;ORAL
MERCAPTOPURINE
AB MYLAN 50MG A040594 001 Jul 01, 2005
AB PROMETHEUS LABS 50MG A040461 001 Feb 11, 2004
AB ROXANE 50MG A040528 001 Feb 13, 2004
PURINETHOL
AB + TEVA 50MG N009053 002
MEROPENEM
INJECTABLE;INJECTION
MEROPENEM
AP ACS DOBFAR 1GM/VIAL A091404 002 Oct 26, 2011
AP 500MG/VIAL A091404 001 Oct 26, 2011
AP HOSPIRA INC 1GM/VIAL A090940 002 Jun 22, 2010
AP 500MG/VIAL A090940 001 Jun 22, 2010
AP SANDOZ 1GM/VIAL A091201 002 Mar 29, 2011
AP 500MG/VIAL A091201 001 Mar 29, 2011
MERREM
AP + ASTRAZENECA 1GM/VIAL N050706 001 Jun 21, 1996
AP + 500MG/VIAL N050706 003 Jun 21, 1996
MESALAMINE
CAPSULE, DELAYED RELEASE;ORAL
DELZICOL
+ WARNER CHILCOTT LLC 400MG N204412 001 Feb 01, 2013
CAPSULE, EXTENDED RELEASE;ORAL
APRISO
+ SALIX PHARMS 375MG N022301 001 Oct 31, 2008
PENTASA
SHIRE 250MG N020049 001 May 10, 1993
+ 500MG N020049 002 Jul 08, 2004
ENEMA;RECTAL
MESALAMINE
AB PERRIGO ISRAEL 4GM/60ML A076751 001 Sep 17, 2004
AB TEVA 4GM/60ML A076841 001 Sep 30, 2004
ROWASA
AB + MEDA PHARMS 4GM/60ML N019618 001 Dec 24, 1987
SFROWASA
AB MEDA PHARMS 4GM/60ML N019618 002 Jun 20, 2008
SUPPOSITORY;RECTAL
CANASA
+ APTALIS PHARMA US 1GM N021252 002 Nov 05, 2004
TABLET, DELAYED RELEASE;ORAL
ASACOL
+ WARNER CHILCOTT LLC 400MG N019651 001 Jan 31, 1992
ASACOL HD
+ WARNER CHILCOTT LLC 800MG N021830 001 May 29, 2008
LIALDA
+ SHIRE 1.2GM N022000 001 Jan 16, 2007
MESNA
INJECTABLE;INTRAVENOUS
MESNA
AP BEDFORD 100MG/ML A075739 001 Jan 09, 2004
AP FRESENIUS KABI USA 100MG/ML A075811 001 Apr 26, 2001
AP MYLAN INSTITUTIONAL 100MG/ML A076488 001 Mar 08, 2012
AP SAGENT PHARMS 100MG/ML A090913 001 Apr 13, 2010
AP TEVA PHARMS USA 100MG/ML A075764 001 Apr 27, 2001
MESNEX
AP + BAXTER HLTHCARE 100MG/ML N019884 001 Dec 30, 1988
TABLET;ORAL
MESNEX
+ BAXTER HLTHCARE 400MG N020855 001 Mar 21, 2002
MESTRANOL; NORETHINDRONE
TABLET;ORAL-28
NORINYL 1+50 28-DAY
+ WATSON LABS 0.05MG;1MG N016659 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-232( of 362)
METAPROTERENOL SULFATE
SOLUTION;INHALATION
METAPROTERENOL SULFATE
AN + DEY 0.4% A071786 001 Aug 05, 1988
AN + 0.6% A070804 001 Aug 17, 1987
AN WOCKHARDT 0.4% A075586 001 May 30, 2002
AN 0.6% A075586 002 May 30, 2002
SYRUP;ORAL
METAPROTERENOL SULFATE
+ SILARX 10MG/5ML A073632 001 Jul 22, 1992
TABLET;ORAL
METAPROTERENOL SULFATE
PAR PHARM 10MG A072024 001 Jun 28, 1988
+ 20MG A072025 001 Jun 28, 1988
METARAMINOL BITARTRATE
INJECTABLE;INJECTION
METARAMINOL BITARTRATE
+ FRESENIUS KABI USA EQ 10MG BASE/ML A080722 001
METAXALONE
TABLET;ORAL
METAXALONE
AB AMNEAL PHARMS 800MG A203399 001 Jun 21, 2013
AB SANDOZ 800MG A040445 001 Mar 31, 2010
SKELAXIN
AB + KING PHARMS 800MG N013217 003 Aug 30, 2002
METFORMIN HYDROCHLORIDE
SOLUTION;ORAL
RIOMET
+ RANBAXY 500MG/5ML N021591 001 Sep 11, 2003
TABLET;ORAL
GLUCOPHAGE
AB + BRISTOL MYERS SQUIBB 1GM N020357 005 Nov 05, 1998
AB 500MG N020357 001 Mar 03, 1995
AB 850MG N020357 002 Mar 03, 1995
METFORMIN HYDROCHLORIDE
AB ALKEM 1GM A091184 003 Nov 01, 2010
AB 500MG A091184 001 Nov 01, 2010
AB 850MG A091184 002 Nov 01, 2010
AB ALVOGEN 1GM A076033 003 Jan 24, 2002
AB 500MG A076033 001 Jan 24, 2002
AB 850MG A076033 002 Jan 24, 2002
AB AMNEAL PHARMS NY 1GM A077880 003 Jun 05, 2006
AB 500MG A077880 001 Jun 05, 2006
AB 850MG A077880 002 Jun 05, 2006
AB APOTEX 1GM A075984 003 Apr 23, 2002
AB 1GM A090666 003 Dec 07, 2011
AB 500MG A075984 001 Apr 23, 2002
AB 500MG A090666 001 Dec 07, 2011
AB 850MG A075984 002 Apr 23, 2002
AB 850MG A090666 002 Dec 07, 2011
AB AUROBINDO 1GM A077095 003 Jan 14, 2005
AB 500MG A077095 001 Jan 14, 2005
AB 850MG A077095 002 Jan 14, 2005
AB CARACO 1GM A075967 003 Jan 29, 2002
AB 500MG A075967 001 Jan 29, 2002
AB 850MG A075967 002 Jan 29, 2002
AB CHARTWELL LIFE SCI 1GM A075972 003 Jan 24, 2002
AB 500MG A075972 001 Jan 24, 2002
AB 850MG A075972 002 Jan 24, 2002
AB DR REDDYS LABS INC 1GM A077787 003 Aug 23, 2006
AB 500MG A077787 001 Aug 23, 2006
AB 850MG A077787 002 Aug 23, 2006
AB GLENMARK GENERICS 1GM A078170 003 May 23, 2008
AB 500MG A078170 001 May 23, 2008
AB 850MG A078170 002 May 23, 2008
AB GRANULES INDIA 1GM A090564 003 Apr 22, 2010
AB 500MG A090564 001 Apr 22, 2010
AB 850MG A090564 002 Apr 22, 2010
AB INDICUS PHARMA 1GM A079148 003 Nov 25, 2008
AB 500MG A079148 001 Nov 25, 2008
AB 850MG A079148 002 Nov 25, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-233( of 362)
METFORMIN HYDROCHLORIDE
TABLET;ORAL
METFORMIN HYDROCHLORIDE
AB MARKSANS PHARMA 1GM A090888 003 Mar 12, 2012
AB 500MG A090888 001 Mar 12, 2012
AB 850MG A090888 002 Mar 12, 2012
AB MUTUAL PHARMA 1GM A076038 003 Feb 21, 2002
AB 500MG A076038 001 Feb 21, 2002
AB 850MG A076038 002 Feb 21, 2002
AB MYLAN 1GM A075973 003 Jan 25, 2002
AB 1GM A075976 003 Jan 24, 2002
AB 500MG A075973 001 Jan 25, 2002
AB 500MG A075976 001 Jan 24, 2002
AB 850MG A075973 002 Jan 25, 2002
AB 850MG A075976 002 Jan 24, 2002
AB MYLAN PHARMS INC 1GM A075969 003 Jan 29, 2002
AB 500MG A075969 001 Jan 29, 2002
AB 850MG A075969 002 Jan 29, 2002
AB PROVIDENT PHARM 1GM A077853 003 Jul 28, 2006
AB 500MG A077853 001 Jul 28, 2006
AB 850MG A077853 002 Jul 28, 2006
AB SANDOZ 1GM A075965 003 Jan 25, 2002
AB 1GM A075985 003 Jan 25, 2002
AB 500MG A075965 001 Jan 25, 2002
AB 500MG A075985 001 Jan 25, 2002
AB 850MG A075965 002 Jan 25, 2002
AB 850MG A075985 002 Jan 25, 2002
AB SCIEGEN PHARMS INC 500MG A203769 001 Sep 11, 2013
AB 850MG A203769 002 Sep 11, 2013
AB 1GM A203769 003 Sep 11, 2013
AB TEVA 1GM A075978 003 Nov 05, 2002
AB 500MG A075978 001 Jan 25, 2002
AB 850MG A075978 002 Jan 25, 2002
AB TORRENT PHARMS 1GM A077711 003 Jan 24, 2007
AB 500MG A077711 001 Jan 24, 2007
AB 850MG A077711 002 Jan 24, 2007
AB WATSON LABS 1GM A075979 003 Jan 24, 2002
AB 500MG A075979 001 Jan 24, 2002
AB 850MG A075979 002 Jan 24, 2002
AB WATSON LABS FLORIDA 1GM A075961 003 Jan 25, 2002
AB 500MG A075961 001 Jan 25, 2002
AB 850MG A075961 002 Jan 25, 2002
AB ZYDUS PHARMS USA 1GM A077064 003 Apr 18, 2005
AB 500MG A077064 001 Apr 18, 2005
AB 850MG A077064 002 Apr 18, 2005
CHARTWELL LIFE SCI 625MG A075972 005 Jan 24, 2002
750MG A075972 004 Jan 24, 2002
TABLET, EXTENDED RELEASE;ORAL
GLUCOPHAGE XR
AB + BRISTOL MYERS SQUIBB 750MG N021202 004 Apr 11, 2003
METFORMIN HYDROCHLORIDE
AB AMNEAL PHARMS NY 750MG A078596 002 Jan 03, 2008
AB APOTEX 750MG A076706 002 Dec 29, 2005
AB AUROBINDO PHARMA LTD 750MG A079118 002 Jul 20, 2012
AB BARR 750MG A076863 001 Oct 14, 2004
AB CSPC OUYI PHARM CO 750MG A078321 002 Apr 17, 2008
AB IMPAX LABS 750MG A076985 001 Sep 13, 2005
AB MYLAN 750MG A077113 001 Sep 08, 2005
AB NOSTRUM PHARMS LLC 750MG A076756 002 Dec 12, 2011
AB SUN PHARM INDS (IN) 750MG A077336 002 Feb 09, 2006
AB TEVA 750MG A076864 001 Apr 12, 2005
AB WATSON LABS FLORIDA 750MG A076869 001 Apr 12, 2005
AB ZYDUS PHARMS USA 750MG A077078 001 Apr 21, 2005
GLUCOPHAGE XR
AB1 BRISTOL MYERS SQUIBB 500MG N021202 001 Oct 13, 2000
METFORMIN HYDROCHLORIDE
AB1 AMNEAL PHARMS NY 500MG A078596 001 Jan 03, 2008
AB1 APOTEX 500MG A076706 001 Dec 14, 2004
AB1 AUROBINDO PHARMA LTD 500MG A079118 001 Jul 20, 2012
AB1 CSPC OUYI PHARM CO 500MG A078321 001 Apr 17, 2008
AB1 IMPAX LABS 500MG A076249 001 Jul 30, 2004
AB1 INVENTIA HLTHCARE 500MG A201991 001 Jan 18, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-234( of 362)
METFORMIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
METFORMIN HYDROCHLORIDE
AB1 MYLAN 500MG A076650 001 Sep 13, 2005
AB1 NOSTRUM PHARMS LLC 500MG A076756 001 Jul 26, 2006
AB1 SANDOZ 500MG A076873 001 Dec 14, 2004
AB1 SUN PHARM INDS (IN) 500MG A077336 001 Feb 09, 2006
AB1 TEVA 500MG A076269 001 Jun 18, 2004
AB1 TORRENT PHARM 500MG A090014 001 Dec 30, 2009
AB1 WATSON LABS FLORIDA 500MG A076172 001 Jun 16, 2004
AB1 ZYDUS PHARMS USA 500MG A077060 001 Apr 20, 2005
FORTAMET
AB2 + ANDRX LABS LLC 1GM N021574 002 Apr 27, 2004
AB2 500MG N021574 001 Apr 27, 2004
METFORMIN HYDROCHLORIDE
AB2 LUPIN LTD 1GM A090692 002 Jun 29, 2011
AB2 500MG A090692 001 Jun 29, 2011
AB2 MYLAN PHARMS INC 1GM A200690 002 Aug 01, 2012
AB2 500MG A200690 001 Aug 01, 2012
GLUMETZA
AB3 + SALIX PHARMS INC 1GM N021748 002 Jun 03, 2005
AB3 500MG N021748 001 Jun 03, 2005
METFORMIN HYDROCHLORIDE
AB3 LUPIN LTD 1GM A091664 002 Jul 19, 2013
AB3 500MG A091664 001 Jul 19, 2013
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
TABLET;ORAL
ACTOPLUS MET
AB TAKEDA PHARMS USA 500MG;EQ 15MG BASE N021842 001 Aug 29, 2005
AB + 850MG;EQ 15MG BASE N021842 002 Aug 29, 2005
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
AB AUROBINDO PHARMA LTD 500MG;EQ 15MG BASE A200823 001 Feb 13, 2013
AB 850MG;EQ 15MG BASE A200823 002 Feb 13, 2013
AB MYLAN 500MG;EQ 15MG BASE A090406 001 Feb 25, 2011
AB 850MG;EQ 15MG BASE A090406 002 Feb 25, 2011
AB SANDOZ 500MG;EQ 15MG BASE A091273 001 Apr 16, 2013
AB 850MG;EQ 15MG BASE A091273 002 Apr 16, 2013
AB TORRENT PHARMS LTD 500MG;EQ 15MG BASE A202001 001 Feb 13, 2013
AB 850MG;EQ 15MG BASE A202001 002 Feb 13, 2013
TABLET, EXTENDED RELEASE;ORAL
ACTOPLUS MET XR
TAKEDA PHARMS USA 1GM;EQ 15MG BASE N022024 001 May 12, 2009
+ 1GM;EQ 30MG BASE N022024 002 May 12, 2009
METFORMIN HYDROCHLORIDE; REPAGLINIDE
TABLET;ORAL
PRANDIMET
NOVO NORDISK INC 500MG;1MG N022386 001 Jun 23, 2008
+ 500MG;2MG N022386 002 Jun 23, 2008
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
TABLET;ORAL
AVANDAMET
SB PHARMCO 1GM;EQ 2MG BASE N021410 004 Aug 25, 2003
+ 1GM;EQ 4MG BASE N021410 005 Aug 25, 2003
500MG;EQ 2MG BASE N021410 002 Oct 10, 2002
500MG;EQ 4MG BASE N021410 003 Oct 10, 2002
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
KOMBIGLYZE XR
BRISTOL MYERS SQUIBB 1GM;EQ 2.5MG BASE N200678 003 Nov 05, 2010
+ 1GM;EQ 5MG BASE N200678 002 Nov 05, 2010
500MG;EQ 5MG BASE N200678 001 Nov 05, 2010
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
TABLET;ORAL
JANUMET
+ MERCK SHARP DOHME 1GM;EQ 50MG BASE N022044 002 Mar 30, 2007
500MG;EQ 50MG BASE N022044 001 Mar 30, 2007
TABLET, EXTENDED RELEASE;ORAL
JANUMET XR
MERCK SHARP DOHME 1GM;EQ 50MG BASE N202270 002 Feb 02, 2012
+ 1GM;EQ 100MG BASE N202270 003 Feb 02, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-235( of 362)
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
TABLET, EXTENDED RELEASE;ORAL
JANUMET XR
500MG;EQ 50MG BASE N202270 001 Feb 02, 2012
METHACHOLINE CHLORIDE
FOR SOLUTION;INHALATION
PROVOCHOLINE
+ METHAPHARM 100MG/VIAL N019193 001 Oct 31, 1986
METHADONE HYDROCHLORIDE
CONCENTRATE;ORAL
METHADONE HYDROCHLORIDE
AA ROXANE 10MG/ML A040180 001 Apr 30, 1998
AA VISTAPHARM 10MG/ML A040088 001 Nov 30, 1994
METHADONE HYDROCHLORIDE INTENSOL
AA ROXANE 10MG/ML A089897 001 Sep 06, 1988
METHADOSE
AA + MALLINCKRODT 10MG/ML N017116 002
INJECTABLE;INJECTION
DOLOPHINE HYDROCHLORIDE
+ MYLAN INSTITUTIONAL 10MG/ML N021624 001
POWDER;FOR RX COMPOUNDING
METHADONE HYDROCHLORIDE
MALLINCKRODT 50GM/BOT N006383 002
100GM/BOT N006383 003
500GM/BOT N006383 004
SOLUTION;ORAL
METHADONE HYDROCHLORIDE
AA + ROXANE 5MG/5ML A087393 001
AA + 10MG/5ML A087997 001 Aug 30, 1982
AA VISTAPHARM 5MG/5ML A090707 001 Jun 30, 2010
AA 10MG/5ML A090707 002 Jun 30, 2010
TABLET;ORAL
DOLOPHINE HYDROCHLORIDE
AA + ROXANE 5MG N006134 002
AA + 10MG N006134 010
METHADONE HYDROCHLORIDE
AA MALLINCKRODT 5MG A040517 001 Apr 27, 2004
AA 10MG A040517 002 Apr 27, 2004
AA SANDOZ 10MG A040241 002 May 29, 1998
AA THE PHARMANETWORK 10MG A090635 001 Nov 25, 2009
METHADOSE
AA MALLINCKRODT 5MG A040050 001 Apr 15, 1993
AA 10MG A040050 002 Apr 15, 1993
TABLET, FOR SUSPENSION;ORAL
METHADONE HYDROCHLORIDE
AA MALLINCKRODT INC 40MG A077142 001 Jul 12, 2005
AA + ROXANE 40MG N017058 001
AA SANDOZ 40MG A075082 001 Mar 25, 1998
METHADOSE
AA MALLINCKRODT 40MG A074184 001 Apr 29, 1993
METHAMPHETAMINE HYDROCHLORIDE
TABLET;ORAL
DESOXYN
AA + RECORDATI RARE 5MG N005378 002
METHAMPHETAMINE HYDROCHLORIDE
AA COASTAL PHARMS 5MG A091189 001 Apr 21, 2010
METHAZOLAMIDE
TABLET;ORAL
METHAZOLAMIDE
AB MIKART 25MG A040062 001 Jan 27, 1994
AB + 50MG A040062 002 Jan 27, 1994
AB SANDOZ 25MG A040036 001 Jun 30, 1993
AB 50MG A040036 002 Jun 30, 1993
AB TEVA PHARMS 25MG A040001 001 Jun 30, 1993
AB 50MG A040001 002 Jun 30, 1993
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-236( of 362)
METHENAMINE HIPPURATE
TABLET;ORAL
HIPREX
AB + SANOFI AVENTIS US 1GM N017681 001
METHENAMINE HIPPURATE
AB COREPHARMA 1GM A076411 001 Jun 20, 2003
UREX
AB CNTY LINE PHARMS 1GM N016151 001
METHIMAZOLE
TABLET;ORAL
METHIMAZOLE
AB BOCA PHARMA LLC 5MG A202068 001 Mar 07, 2012
AB 10MG A202068 002 Mar 07, 2012
AB CARACO 5MG A040870 001 Sep 25, 2007
AB 10MG A040870 002 Sep 25, 2007
AB CEDAR PHARMS 5MG A040547 001 Feb 18, 2005
AB 10MG A040547 002 Feb 18, 2005
AB EMCURE PHARMS USA 5MG A040734 001 Dec 14, 2007
AB 10MG A040734 002 Dec 14, 2007
AB MYLAN 5MG A040350 001 Mar 29, 2000
AB + 10MG A040350 002 Mar 29, 2000
AB SANDOZ 5MG A040411 001 Mar 27, 2001
AB 10MG A040411 002 Mar 27, 2001
TAPAZOLE
AB KING PHARMS 5MG A040320 001 Mar 31, 2000
AB 10MG A040320 002 Mar 31, 2000
METHOCARBAMOL
INJECTABLE;INJECTION
ROBAXIN
+ HIKMA MAPLE 100MG/ML N011790 001
TABLET;ORAL
METHOCARBAMOL
AA AUSTARPHARMA LLC 500MG A200958 001 Oct 21, 2011
AA 750MG A200958 002 Oct 21, 2011
AA HETERO LABS LTD III 500MG A090200 001 Nov 06, 2009
AA 750MG A090200 002 Nov 06, 2009
AA HIKMA PHARMS 750MG A085123 001
AA LANNETT HOLDINGS INC 500MG A084756 002 Mar 31, 2003
AA 750MG A084756 001
AA PRINSTON INC 500MG A086989 001
AA 750MG A086988 001
AA SANDOZ 500MG A084616 001
AA 750MG A084615 001
AA VINTAGE PHARMS 500MG A040489 001 Jan 29, 2003
AA 750MG A040489 002 Jan 29, 2003
AA WATSON LABS 500MG A084277 001
AA 500MG A085180 001
AA 750MG A084276 002
AA 750MG A085192 001
AA WEST WARD 500MG A085159 001
ROBAXIN
AA + ACTIENT PHARMS 500MG N011011 004
ROBAXIN-750
AA + ACTIENT PHARMS 750MG N011011 006
METHOHEXITAL SODIUM
INJECTABLE;INJECTION
BREVITAL SODIUM
+ JHP PHARMS 2.5GM/VIAL N011559 002
+ 200MG/VIAL N011559 004 Dec 21, 2012
+ 500MG/VIAL N011559 001
METHOTREXATE
SOLUTION;SUBCUTANEOUS
OTREXUP
ANTARES PHARMA INC 10MG/0.4ML N204824 001 Oct 11, 2013
15MG/0.4ML N204824 002 Oct 11, 2013
20MG/0.4ML N204824 003 Oct 11, 2013
+ 25MG/0.4ML N204824 004 Oct 11, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-237( of 362)
METHOTREXATE SODIUM
INJECTABLE;INJECTION
METHOTREXATE PRESERVATIVE FREE
AP FRESENIUS KABI USA EQ 1GM BASE/VIAL A040266 001 Feb 26, 1999
AP PHARMACHEMIE BV EQ 100MG BASE/4ML (EQ 25MG BASE/ML) A200171 001 Feb 27, 2012
METHOTREXATE SODIUM
AP + BEDFORD EQ 100MG BASE/4ML (EQ 25MG BASE/ML) A089341 001 Sep 16, 1986
AP + FRESENIUS KABI USA EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040263 001 Feb 26, 1999
AP + EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A040263 002 Feb 26, 1999
AP + HOSPIRA EQ 50MG BASE/2ML (EQ 25MG BASE/ML) N011719 010 Dec 15, 2004
METHOTREXATE SODIUM PRESERVATIVE FREE
AP + ACCORD HLTHCARE EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A040716 001 Apr 30, 2007
AP + EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040767 001 Apr 30, 2007
AP + EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A040768 001 Apr 30, 2007
AP + BEDFORD EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A089340 001 Sep 16, 1986
AP + EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A089343 001 Sep 16, 1986
AP EBEWE PHARMA EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A090029 001 Mar 31, 2009
AP EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A090039 001 Mar 31, 2009
AP EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A090039 002 Mar 31, 2009
AP + HOSPIRA EQ 1GM BASE/40ML (EQ 25MG BASE/ML) N011719 012 Apr 13, 2005
AP ONCO THERAPIES LTD EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A201530 001 Mar 29, 2012
AP EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A201529 001 Mar 29, 2012
AP EQ 100MG BASE/4ML (EQ 25MG BASE/ML) A201529 002 Mar 29, 2012
AP EQ 200MG BASE/8ML (EQ 25MG BASE/ML) A201529 003 Mar 29, 2012
AP EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A201529 004 Mar 29, 2012
AP PHARMACHEMIE BV EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A040843 001 Jan 11, 2010
AP EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040850 001 Jan 11, 2010
AP EQ 250MG/10ML (EQ 25MG BASE/ML) A040853 001 Jan 11, 2010
METHOTREXATE SODIUM
+ BEDFORD EQ 200MG BASE/8ML (EQ 25MG BASE/ML) A089342 001 Sep 16, 1986
METHOTREXATE SODIUM PRESERVATIVE FREE
+ BEDFORD EQ 1GM BASE/VIAL A040632 001 Aug 12, 2005
TABLET;ORAL
METHOTREXATE SODIUM
AB BARR EQ 2.5MG BASE A081099 001 Oct 15, 1990
AB + DAVA PHARMS INC EQ 2.5MG BASE N008085 002
AB MYLAN EQ 2.5MG BASE A081235 001 May 15, 1992
AB ROXANE EQ 2.5MG BASE A040054 001 Aug 01, 1994
TREXALL
BARR EQ 5MG BASE A040385 001 Mar 21, 2001
EQ 7.5MG BASE A040385 002 Mar 21, 2001
EQ 10MG BASE A040385 003 Mar 21, 2001
+ EQ 15MG BASE A040385 004 Mar 21, 2001
METHOXSALEN
CAPSULE;ORAL
8-MOP
+ VALEANT PHARM INTL 10MG N009048 001
OXSORALEN-ULTRA
+ DOW PHARM 10MG N019600 001 Oct 30, 1986
INJECTABLE;INJECTION
UVADEX
+ THERAKOS 0.02MG/ML N020969 001 Feb 25, 1999
LOTION;TOPICAL
OXSORALEN
+ VALEANT PHARM INTL 1% N009048 002
METHSCOPOLAMINE BROMIDE
TABLET;ORAL
METHSCOPOLAMINE BROMIDE
AA BAYSHORE PHARMS LLC 2.5MG A200602 001 Sep 24, 2012
AA 5MG A200602 002 Sep 24, 2012
AA BOCA PHARMA LLC 2.5MG A040624 001 Dec 28, 2006
AA 5MG A040624 002 Dec 28, 2006
AA BRECKENRIDGE PHARM 2.5MG A040642 001 Dec 06, 2011
AA 5MG A040642 002 Dec 06, 2011
PAMINE
AA + FOUGERA PHARMS 2.5MG N008848 001
PAMINE FORTE
AA + FOUGERA PHARMS 5MG N008848 002 Mar 25, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
METHSUXIMIDE
CAPSULE;ORAL
CELONTIN
PARKE DAVIS
+
METHYCLOTHIAZIDE
TABLET;ORAL
METHYCLOTHIAZIDE
+ MYLAN PHARMS INC
METHYLDOPA
TABLET;ORAL
METHYLDOPA
AB ACCORD HLTHCARE
AB
AB IVAX SUB TEVA PHARMS
AB
AB MYLAN
AB +
AB WATSON LABS
METHYLDOPATE HYDROCHLORIDE
INJECTABLE;INJECTION
METHYLDOPATE HYDROCHLORIDE
AP + LUITPOLD
METHYLERGONOVINE MALEATE
INJECTABLE;INJECTION
METHERGINE
AP + US PHARMS HOLDINGS I
METHYLERGONOVINE MALEATE
AP ERGOJECT
AP LUITPOLD
TABLET;ORAL
METHERGINE
AB + US PHARMS HOLDINGS I
METHYLERGONOVINE MALEATE
AB NOVEL LABS INC
METHYLNALTREXONE BROMIDE
INJECTABLE;SUBCUTANEOUS
RELISTOR
SALIX PHARMS
+
SOLUTION;SUBCUTANEOUS
RELISTOR
+ SALIX PHARMS
METHYLPHENIDATE
150MG
300MG
5MG
250MG
500MG
250MG
500MG
250MG
500MG
500MG
50MG/ML
0.2MG/ML
0.2MG/ML
0.2MG/ML
0.2MG
0.2MG
8MG/0.4ML
12MG/0.6ML (12MG/0.6ML)
12MG/0.6ML (12MG/0.6ML)
FILM, EXTENDED RELEASE;TRANSDERMAL
DAYTRANA
NOVEN PHARMS INC 10MG/9HR (1.1MG/HR)
15MG/9HR (1.6MG/HR)
20MG/9HR (2.2MG/HR)
+ 30MG/9HR (3.3MG/HR)
METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
METHYLPHENIDATE HYDROCHLORIDE
AB1 BARR LABS INC 20MG
AB1 30MG
AB1 40MG
AB1 WATSON LABS INC 20MG
AB1 30MG
AB1 40MG
RITALIN LA
AB1 NOVARTIS 20MG
AB1 30MG
AB1 + 40MG
METADATE CD
AB2 UCB INC 10MG
AB2 20MG
AB2 30MG
AB2 40MG
AB2 50MG
3-238( of 362)
N010596 007
N010596 008
A087672 001 Aug 17, 1982
A070084 001 Oct 15, 1985
A070085 001 Oct 15, 1985
A070098 001 Feb 20, 1986
A070343 001 Feb 20, 1986
A070075 001 Apr 18, 1985
A070076 001 Apr 18, 1985
A070625 001 Jun 06, 1986
A071279 001 Oct 02, 1987
N006035 004
A040889 001 Sep 13, 2010
A090193 001 Nov 24, 2008
N006035 003
A091577 001 May 02, 2011
N021964 002 Sep 27, 2010
N021964 003 Apr 24, 2008
N021964 001 Apr 24, 2008
N021514 001 Apr 06, 2006
N021514 002 Apr 06, 2006
N021514 003 Apr 06, 2006
N021514 004 Apr 06, 2006
A079031 001 Jul 13, 2012
A079031 002 Jul 13, 2012
A079031 003 Jul 13, 2012
A078458 001 Dec 01, 2011
A078458 002 Dec 01, 2011
A078458 003 Dec 01, 2011
N021284 001 Jun 05, 2002
N021284 002 Jun 05, 2002
N021284 003 Jun 05, 2002
N021259 003 May 27, 2003
N021259 001 Apr 03, 2001
N021259 002 Jun 19, 2003
N021259 004 Feb 19, 2006
N021259 005 Feb 19, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-239( of 362)
METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
METADATE CD
AB2 + 60MG N021259 006 Feb 19, 2006
METHYLPHENIDATE HYDROCHLORIDE
AB2 TEVA PHARMS 10MG A077707 001 Jul 19, 2012
AB2 20MG A077707 002 Jul 19, 2012
AB2 30MG A077707 003 Jul 19, 2012
AB2 40MG A078873 001 Jul 19, 2012
AB2 50MG A078873 002 Jul 19, 2012
AB2 60MG A078873 003 Jul 19, 2012
RITALIN LA
BX NOVARTIS 10MG N021284 004 Apr 10, 2004
FOR SUSPENSION, EXTENDED RELEASE;ORAL
QUILLIVANT XR
+ NEXTWAVE PHARMS 5MG/ML N202100 001 Sep 27, 2012
SOLUTION;ORAL
METHYLIN
AA + MALLINCKRODT 5MG/5ML N021419 001 Dec 19, 2002
AA + 10MG/5ML N021419 002 Dec 19, 2002
METHYLPHENIDATE HYDROCHLORIDE
AA CARACO 5MG/5ML A201466 001 Nov 12, 2013
AA 10MG/5ML A201466 002 Nov 12, 2013
AA TRIS PHARMA INC 5MG/5ML A091601 001 Jul 23, 2010
AA 10MG/5ML A091601 002 Jul 23, 2010
TABLET;ORAL
METHYLPHENIDATE HYDROCHLORIDE
AB CARACO 5MG A090710 001 Mar 15, 2012
AB 10MG A090710 002 Mar 15, 2012
AB 20MG A090710 003 Mar 15, 2012
AB MALLINCKRODT 5MG A040300 001 Nov 27, 1998
AB 10MG A040300 002 Nov 27, 1998
AB 20MG A040300 003 Nov 27, 1998
AB UCB INC 5MG A086429 001
AB 10MG A085799 001
AB 20MG A086428 001
AB WATSON LABS 5MG A040220 001 Aug 29, 1997
AB 10MG A040220 002 Aug 29, 1997
AB 20MG A040220 003 Aug 29, 1997
RITALIN
AB NOVARTIS 5MG N010187 003
AB 10MG N010187 006
AB + 20MG N010187 010
TABLET, CHEWABLE;ORAL
METHYLIN
MALLINCKRODT 2.5MG N021475 001 Apr 15, 2003
5MG N021475 002 Apr 15, 2003
+ 10MG N021475 003 Apr 15, 2003
TABLET, EXTENDED RELEASE;ORAL
CONCERTA
AB JANSSEN PHARMS 18MG N021121 001 Aug 01, 2000
AB 27MG N021121 004 Apr 01, 2002
AB 36MG N021121 002 Aug 01, 2000
AB + 54MG N021121 003 Dec 08, 2000
METADATE ER
AB + UCB INC 20MG A089601 001 Jun 01, 1988
METHYLIN ER
AB MALLINCKRODT INC 20MG A075629 002 May 09, 2000
METHYLPHENIDATE HYDROCHLORIDE
AB KUDCO IRELAND 18MG A091695 001 Jul 09, 2013
AB 27MG A091695 002 Jul 09, 2013
AB 36MG A091695 003 Sep 23, 2013
AB 54MG A091695 004 Sep 23, 2013
AB MALLINCKRODT INC 27MG A202608 001 Dec 28, 2012
AB 36MG A202608 002 Dec 28, 2012
AB 54MG A202608 003 Dec 28, 2012
AB WATSON LABS 20MG A040410 001 Feb 09, 2001
RITALIN-SR
AB NOVARTIS 20MG N018029 001 Mar 30, 1982
METHYLIN ER
MALLINCKRODT INC 10MG A075629 001 May 09, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-240( of 362)
METHYLPREDNISOLONE
TABLET;ORAL
MEDROL
AB PHARMACIA AND UPJOHN 2MG N011153 002
AB 4MG N011153 001
AB 8MG N011153 004
AB 16MG N011153 003
AB + 32MG N011153 006
METHYLPREDNISOLONE
AB DURAMED PHARMS BARR 4MG A088497 001 Feb 21, 1984
AB JUBILANT CADISTA 4MG A040189 001 Oct 31, 1997
AB 8MG A040189 002 Oct 31, 1997
AB 16MG A040189 003 Jul 20, 2007
AB 32MG A040189 004 Jul 20, 2007
AB SANDOZ 4MG A040194 001 Oct 31, 1997
AB VINTAGE PHARMS 4MG A040183 001 Dec 22, 1998
AB WATSON LABS 4MG A040232 001 Oct 16, 1997
METHYLPREDNISOLONE ACETATE
INJECTABLE;INJECTION
DEPO-MEDROL
AB + PHARMACIA AND UPJOHN 40MG/ML N011757 001
AB + 80MG/ML N011757 004
METHYLPREDNISOLONE ACETATE
AB SANDOZ 40MG/ML A040719 001 Jan 29, 2009
AB 40MG/ML A040794 001 Mar 05, 2009
AB 80MG/ML A040719 002 Jan 29, 2009
AB 80MG/ML A040794 002 Mar 05, 2009
AB TEVA PHARMS USA 40MG/ML A040557 001 Feb 23, 2005
AB 40MG/ML A040620 001 Oct 27, 2006
AB 80MG/ML A040557 002 Feb 23, 2005
AB 80MG/ML A040620 002 Oct 27, 2006
DEPO-MEDROL
+ PHARMACIA AND UPJOHN 20MG/ML N011757 002
METHYLPREDNISOLONE SODIUM SUCCINATE
INJECTABLE;INJECTION
A-METHAPRED
AP HOSPIRA EQ 40MG BASE/VIAL A040664 001 Dec 20, 2005
AP EQ 125MG BASE/VIAL A040665 001 Dec 20, 2005
AP HOSPIRA INC EQ 40MG BASE/VIAL A040793 001 Nov 25, 2008
AP EQ 125MG BASE/VIAL A040827 001 Nov 25, 2008
METHYLPREDNISOLONE SODIUM SUCCINATE
AP FRESENIUS KABI USA EQ 1GM BASE/VIAL A040612 001 Aug 12, 2004
AP EQ 40MG BASE/VIAL A040583 001 Jul 30, 2004
AP EQ 125MG BASE/VIAL A040583 002 Jul 30, 2004
AP MUSTAFA NEVSAT EQ 1GM BASE/VIAL A040888 004 Jul 18, 2011
AP EQ 2GM BASE/VIAL A040888 005 Jul 18, 2011
AP EQ 40MG BASE/VIAL A040888 001 Jul 18, 2011
AP EQ 125MG BASE/VIAL A040888 002 Jul 18, 2011
AP EQ 500MG BASE/VIAL A040888 003 Jul 18, 2011
SOLU-MEDROL
AP + PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL N011856 006
AP + EQ 2GM BASE/VIAL N011856 007 Feb 27, 1985
AP + EQ 40MG BASE/VIAL N011856 003
AP + EQ 125MG BASE/VIAL N011856 004
AP + EQ 500MG BASE/VIAL N011856 005
METHYLTESTOSTERONE
CAPSULE;ORAL
TESTRED
+ VALEANT PHARM INTL 10MG A083976 001
TABLET;ORAL
ANDROID 10
BP VALEANT PHARM INTL 10MG A086450 001
ANDROID 25
BP + VALEANT PHARM INTL 25MG A087147 001
METHYLTESTOSTERONE
BP IMPAX LABS 10MG A080767 002
BP 25MG A084310 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-241( of 362)
METIPRANOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
METIPRANOLOL
AT FALCON PHARMS 0.3% A075720 001 Aug 06, 2001
OPTIPRANOLOL
AT + BAUSCH AND LOMB 0.3% N019907 001 Dec 29, 1989
METOCLOPRAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
METOCLOPRAMIDE
AP EMCURE PHARMS LTD EQ 5MG BASE/ML A204756 001 Dec 20, 2013
METOCLOPRAMIDE HYDROCHLORIDE
AP BD RX EQ 5MG BASE/ML A091392 001 Apr 19, 2013
AP HOSPIRA EQ 5MG BASE/ML A073118 001 Jan 17, 1991
AP TEVA PHARMS USA EQ 5MG BASE/ML A073135 001 Nov 27, 1991
REGLAN
AP + BAXTER HLTHCARE CORP EQ 5MG BASE/ML N017862 001
SOLUTION;ORAL
METOCLOPRAMIDE HYDROCHLORIDE
AA ANI PHARMS EQ 5MG BASE/5ML A071402 001 Jun 25, 1993
AA PHARM ASSOC EQ 5MG BASE/5ML A072744 001 May 28, 1991
AA SILARX EQ 5MG BASE/5ML A073680 001 Oct 27, 1992
AA VISTAPHARM EQ 5MG BASE/5ML A075051 001 Jan 26, 2001
AA + WOCKHARDT EQ 5MG BASE/5ML A074703 001 Oct 31, 1997
TABLET;ORAL
METOCLOPRAMIDE HYDROCHLORIDE
AB IPCA LABS LTD EQ 5MG BASE A078807 001 Jun 12, 2008
AB EQ 10MG BASE A078807 002 Jun 12, 2008
AB MUTUAL PHARM EQ 5MG BASE A071536 002 Jan 16, 1997
AB NORTHSTAR HLTHCARE EQ 5MG BASE A078374 001 Nov 30, 2007
AB EQ 10MG BASE A078374 002 Nov 30, 2007
AB PAR PHARM INC EQ 10MG BASE A070581 001 Oct 17, 1985
AB TEVA EQ 5MG BASE A072801 001 Jun 15, 1993
AB EQ 10MG BASE A070184 001 Jul 29, 1985
AB VINTAGE PHARMS EQ 5MG BASE A077878 001 Aug 28, 2006
AB EQ 10MG BASE A077878 002 Aug 28, 2006
AB WATSON LABS EQ 5MG BASE A072750 001 Dec 28, 1995
AB EQ 10MG BASE A071250 001 Feb 03, 1988
REGLAN
AB ANI PHARMS EQ 5MG BASE N017854 002 May 05, 1987
AB + EQ 10MG BASE N017854 001
TABLET, ORALLY DISINTEGRATING;ORAL
METOZOLV ODT
+ SALIX PHARMS EQ 5MG BASE N022246 001 Sep 04, 2009
METOLAZONE
TABLET;ORAL
METOLAZONE
AB MYLAN 2.5MG A076698 001 Dec 23, 2003
AB 5MG A076698 002 Oct 19, 2004
AB 10MG A076698 003 Oct 19, 2004
AB SANDOZ 2.5MG A076732 001 Dec 19, 2003
AB 5MG A076466 001 Dec 19, 2003
AB 10MG A076466 002 Dec 19, 2003
ZAROXOLYN
AB UCB INC 2.5MG N017386 001
AB + 5MG N017386 002
AB + 10MG N017386 003
METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
METOPROLOL SUCCINATE
AB DR REDDYS LABS LTD EQ 25MG TARTRATE A090617 001 Aug 01, 2012
AB EQ 50MG TARTRATE A090617 002 Aug 01, 2012
AB MYLAN PHARMS INC EQ 25MG TARTRATE A202033 001 Dec 15, 2011
AB EQ 50MG TARTRATE A202033 002 Dec 15, 2011
AB EQ 100MG TARTRATE A202033 003 Dec 15, 2011
AB EQ 200MG TARTRATE A202033 004 Dec 15, 2011
AB REDDYS EQ 100MG BASE A078889 001 Aug 15, 2012
AB EQ 200MG BASE A078889 002 Aug 15, 2012
AB WATSON LABS FLORIDA EQ 25MG TARTRATE A077118 001 Aug 03, 2009
AB EQ 50MG TARTRATE A076862 001 Aug 03, 2009
AB EQ 100MG TARTRATE A077298 001 Apr 15, 2010
AB EQ 200MG TARTRATE A077298 002 Apr 15, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-242( of 362)
METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
METOPROLOL SUCCINATE
AB WOCKHARDT EQ 25MG TARTRATE A090615 001 Jul 22, 2010
AB EQ 50MG TARTRATE A090615 002 Jul 22, 2010
AB EQ 100MG TARTRATE A090615 003 Jul 22, 2010
AB EQ 200MG TARTRATE A090615 004 Jul 22, 2010
TOPROL-XL
AB ASTRAZENECA EQ 25MG TARTRATE N019962 004 Feb 05, 2001
AB + EQ 50MG TARTRATE N019962 001 Jan 10, 1992
AB EQ 100MG TARTRATE N019962 002 Jan 10, 1992
AB + EQ 200MG TARTRATE N019962 003 Jan 10, 1992
METOPROLOL TARTRATE
INJECTABLE;INJECTION
LOPRESSOR
AP + NOVARTIS 1MG/ML N018704 001 Mar 30, 1984
METOPROLOL TARTRATE
AP BEDFORD LABS 1MG/ML A076495 001 Jul 07, 2003
AP CLARIS LIFESCIENCES 1MG/ML A078950 001 Apr 29, 2013
AP FRESENIUS KABI USA 1MG/ML A091045 001 Oct 25, 2010
AP HIKMA FARMACEUTICA 1MG/ML A077761 001 May 30, 2007
AP HOSPIRA 1MG/ML A074133 001 Dec 21, 1993
AP 1MG/ML A075160 001 Jul 06, 1998
AP 1MG/ML A078085 001 Apr 29, 2008
AP LUITPOLD 1MG/ML A090386 001 Sep 30, 2009
AP 1MG/ML A091307 001 Dec 29, 2010
AP SAGENT STRIDES 1MG/ML A090317 001 Apr 19, 2010
AP SANDOZ 1MG/ML A077360 001 Oct 02, 2007
TABLET;ORAL
LOPRESSOR
AB US PHARMS HOLDINGS I 50MG N017963 001
AB 100MG N017963 002
METOPROLOL TARTRATE
AB ALEMBIC PHARMS LTD 25MG A202871 001 May 28, 2013
AB 50MG A202871 002 May 28, 2013
AB 100MG A202871 003 May 28, 2013
AB AUROBINDO PHARMA 25MG A077739 001 Sep 11, 2007
AB 50MG A077739 002 Sep 11, 2007
AB 100MG A077739 003 Sep 11, 2007
AB CARACO 25MG A076670 001 Jan 15, 2004
AB 50MG A074644 001 Dec 10, 1996
AB 100MG A074644 002 Dec 10, 1996
AB IPCA LABS LTD 25MG A078459 001 Jun 17, 2008
AB 50MG A078459 002 Jun 17, 2008
AB 100MG A078459 003 Jun 17, 2008
AB MUTUAL PHARM 25MG A073654 002 Jul 15, 2009
AB 50MG A073653 001 Dec 21, 1993
AB 100MG A073654 001 Dec 21, 1993
AB MYLAN 25MG A076704 001 Jan 16, 2004
AB 50MG A076704 002 Jan 16, 2004
AB + 100MG A076704 003 Jan 16, 2004
AB SANDOZ 50MG A073288 001 Mar 25, 1994
AB 100MG A073289 001 Mar 25, 1994
AB TEVA 50MG A074141 001 Jan 31, 1995
AB 100MG A074141 002 Jan 31, 1995
AB WATSON LABS 50MG A074217 001 May 27, 1994
AB 100MG A074217 002 May 27, 1994
METRONIDAZOLE
CAPSULE;ORAL
FLAGYL
AB + GD SEARLE LLC 375MG N020334 001 May 03, 1995
METRONIDAZOLE
AB ALEMBIC LTD 375MG A079065 001 Jun 23, 2009
AB PAR PHARM 375MG A076522 001 Jan 29, 2004
CREAM;TOPICAL
METROCREAM
AB + GALDERMA LABS LP 0.75% N020531 001 Sep 20, 1995
METRONIDAZOLE
AB FOUGERA PHARMS 0.75% A076408 001 May 28, 2004
AB G AND W LABS 0.75% A077549 001 Dec 19, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-243( of 362)
METRONIDAZOLE
CREAM;TOPICAL
NORITATE
+ VALEANT BERMUDA 1% N020743 001 Sep 26, 1997
GEL;TOPICAL
METROGEL
AB + GALDERMA LABS LP 0.75% N019737 001 Nov 22, 1988
AB + 1% N021789 001 Jun 30, 2005
METRONIDAZOLE
AB FOUGERA PHARMS 0.75% A077018 001 Jun 06, 2006
AB G AND W LABS INC 0.75% A078178 001 Jan 19, 2011
AB TARO 0.75% A077819 001 Jul 18, 2006
AB TOLMAR 0.75% A077547 001 Jul 13, 2006
AB 1% A090903 001 Jul 22, 2011
GEL;VAGINAL
METROGEL-VAGINAL
AB + MEDICIS 0.75% N020208 001 Aug 17, 1992
METRONIDAZOLE
AB TOLMAR 0.75% A077264 001 Oct 31, 2006
VANDAZOLE
BX TEVA PHARMS 0.75% N021806 001 May 20, 2005
INJECTABLE;INJECTION
FLAGYL I.V. RTU IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 500MG/100ML N018657 001
AP + PFIZER 500MG/100ML N018353 002
METRO I.V. IN PLASTIC CONTAINER
AP + B BRAUN 500MG/100ML N018900 001 Sep 29, 1983
METRONIDAZOLE IN PLASTIC CONTAINER
AP CLARIS LIFESCIENCES 500MG/100ML A078084 001 Mar 31, 2008
AP + HOSPIRA 500MG/100ML N018890 002 Nov 18, 1983
LOTION;TOPICAL
METROLOTION
AB + GALDERMA LABS LP 0.75% N020901 001 Nov 24, 1998
METRONIDAZOLE
AB FOUGERA PHARMS 0.75% A077197 001 May 24, 2006
TABLET;ORAL
FLAGYL
AB GD SEARLE LLC 250MG N012623 001
AB + 500MG N012623 003
METRONIDAZOLE
AB ALEMBIC PHARMS LTD 250MG A079067 001 Mar 13, 2009
AB 500MG A079067 002 Mar 13, 2009
AB MUTUAL PHARM 250MG A070772 001 Jul 16, 1986
AB 500MG A070773 001 Jul 16, 1986
AB PLIVA 500MG A070033 001 Dec 06, 1984
AB TEVA 500MG A070044 001 Feb 08, 1985
AB TEVA PHARMS USA 250MG A070027 001 Nov 06, 1984
AB WATSON LABS 250MG A070035 001 Dec 20, 1984
AB 250MG N018764 001 Sep 17, 1982
AB 500MG N018764 002 Dec 20, 1982
TABLET, EXTENDED RELEASE;ORAL
FLAGYL ER
AB + GD SEARLE LLC 750MG N020868 001 Nov 26, 1997
METRONIDAZOLE
AB ALEMBIC LTD 750MG A090222 001 May 05, 2010
METYRAPONE
CAPSULE;ORAL
METOPIRONE
+ HRA PHARMA 250MG N012911 002 Aug 09, 1996
METYROSINE
CAPSULE;ORAL
DEMSER
+ ATON PHARMA VPNA 250MG N017871 001
MEXILETINE HYDROCHLORIDE
CAPSULE;ORAL
MEXILETINE HYDROCHLORIDE
TEVA 150MG A074377 001 May 16, 1995
200MG A074377 002 May 16, 1995
+ 250MG A074377 003 May 16, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-244( of 362)
MICAFUNGIN SODIUM
INJECTABLE;IV (INFUSION)
MYCAMINE
+ ASTELLAS 50MG/VIAL N021506 002 Mar 16, 2005
+ 100MG/VIAL N021506 003 Jun 27, 2006
MICONAZOLE
TABLET;BUCCAL
ORAVIG
+ VESTIQ PHARMS 50MG N022404 001 Apr 16, 2010
MICONAZOLE NITRATE
SUPPOSITORY;VAGINAL
MICONAZOLE NITRATE
AB ACTAVIS MID ATLANTIC 200MG A073508 001 Nov 19, 1993
MONISTAT 3
AB + INSIGHT PHARMS 200MG N018888 001 Aug 15, 1984
MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE
OINTMENT;TOPICAL
VUSION
+ STIEFEL LABS INC 0.25%;81.35%;15% N021026 001 Feb 16, 2006
MIDAZOLAM HYDROCHLORIDE
INJECTABLE;INJECTION
MIDAZOLAM HYDROCHLORIDE
AP AKORN INC EQ 1MG BASE/ML A075494 001 Jun 30, 2000
AP EQ 5MG BASE/ML A075481 001 Jun 30, 2000
AP EQ 5MG BASE/ML A075494 002 Jun 30, 2000
AP BEDFORD EQ 1MG BASE/ML A075247 002 Jun 23, 2000
AP EQ 5MG BASE/ML A075247 001 Jun 23, 2000
AP BEN VENUE EQ 1MG BASE/ML A075421 002 Jun 20, 2000
AP EQ 5MG BASE/ML A075421 001 Jun 20, 2000
AP FRESENIUS KABI USA EQ 1MG BASE/ML A075154 002 Jun 20, 2000
AP EQ 5MG BASE/ML A075154 001 Jun 20, 2000
AP GLAND PHARMA LTD EQ 1MG BASE/ML A090696 001 Feb 29, 2012
AP EQ 5MG BASE/ML A090850 001 Jan 25, 2012
AP HIKMA MAPLE EQ 1MG BASE/ML A075243 001 Jun 20, 2000
AP EQ 1MG BASE/ML A075324 001 Jun 20, 2000
AP EQ 5MG BASE/ML A075243 002 Jun 20, 2000
AP EQ 5MG BASE/ML A075324 002 Jun 20, 2000
AP + HOSPIRA EQ 1MG BASE/ML A075293 001 Jun 20, 2000
AP EQ 1MG BASE/ML A075856 001 Jun 13, 2002
AP + EQ 5MG BASE/ML A075293 002 Jun 20, 2000
AP EQ 5MG BASE/ML A075856 002 Jun 13, 2002
AP WOCKHARDT EQ 1MG BASE/ML A078141 001 May 30, 2008
AP EQ 1MG BASE/ML A078511 001 Nov 10, 2008
AP EQ 5MG BASE/ML A078141 002 May 30, 2008
AP EQ 5MG BASE/ML A078511 002 Nov 10, 2008
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
AP + HOSPIRA EQ 1MG BASE/ML A075857 001 Jul 22, 2002
AP + EQ 5MG BASE/ML A075857 002 Jul 22, 2002
AP SAGENT STRIDES EQ 1MG BASE/ML A090315 001 Nov 29, 2010
AP EQ 5MG BASE/ML A090315 002 Nov 29, 2010
MIDOZALAM HYDROCHLORIDE
AP SAGENT STRIDES EQ 1MG BASE/ML A090316 001 May 04, 2011
AP EQ 5MG BASE/ML A090316 002 May 04, 2011
SYRUP;ORAL
MIDAZOLAM HYDROCHLORIDE
AA HI TECH PHARMA EQ 2MG BASE/ML A075958 001 Sep 04, 2003
AA PADDOCK LLC EQ 2MG BASE/ML A076379 001 May 02, 2005
AA RANBAXY EQ 2MG BASE/ML A076058 001 Mar 15, 2002
AA + ROXANE EQ 2MG BASE/ML A075873 001 Apr 30, 2002
MIDODRINE HYDROCHLORIDE
TABLET;ORAL
MIDODRINE HYDROCHLORIDE
AB APOTEX INC 2.5MG A077746 001 Sep 12, 2006
AB 5MG A077746 002 Sep 12, 2006
AB 10MG A077746 003 Sep 12, 2006
AB IMPAX PHARMS 2.5MG A076449 001 May 27, 2004
AB 5MG A076449 002 May 27, 2004
AB 10MG A076449 003 Dec 16, 2005
AB MYLAN PHARMS INC 2.5MG A076577 001 Sep 10, 2003
AB + 5MG A076577 002 Sep 10, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-245( of 362)
MIDODRINE HYDROCHLORIDE
TABLET;ORAL
MIDODRINE HYDROCHLORIDE
AB 10MG A076577 003 Sep 10, 2003
AB SANDOZ 2.5MG A076514 001 Sep 11, 2003
AB 5MG A076514 002 Sep 11, 2003
AB 10MG A076514 003 Jul 02, 2004
ORVATEN
AB UPSHER SMITH 2.5MG A076725 001 Nov 03, 2004
AB 5MG A076725 002 Nov 03, 2004
AB 10MG A076725 003 Nov 03, 2004
MIFEPRISTONE
TABLET;ORAL
KORLYM
+ CORCEPT THERAP 300MG N202107 001 Feb 17, 2012
MIFEPREX
+ DANCO LABS LLC 200MG N020687 001 Sep 28, 2000
MIGLITOL
TABLET;ORAL
GLYSET
PHARMACIA AND UPJOHN 25MG N020682 001 Dec 18, 1996
50MG N020682 002 Dec 18, 1996
+ 100MG N020682 003 Dec 18, 1996
MIGLUSTAT
CAPSULE;ORAL
ZAVESCA
+ ACTELION PHARMS LTD 100MG N021348 001 Jul 31, 2003
MILNACIPRAN HYDROCHLORIDE
TABLET;ORAL
SAVELLA
CYPRESS BIOSCIENCE 12.5MG N022256 001 Jan 14, 2009
25MG N022256 002 Jan 14, 2009
+ 50MG N022256 003 Jan 14, 2009
100MG N022256 004 Jan 14, 2009
MILRINONE LACTATE
INJECTABLE;INJECTION
MILRINONE LACTATE
AP + BEDFORD EQ 1MG BASE/ML A075660 001 May 28, 2002
AP FRESENIUS KABI USA EQ 1MG BASE/ML A075936 001 May 28, 2002
AP GLAND PHARMA LTD EQ 1MG BASE/ML A077190 001 Oct 31, 2006
AP HIKMA FARMACEUTICA EQ 1MG BASE/ML A077966 001 Dec 03, 2010
AP HIKMA MAPLE EQ 1MG BASE/ML A075530 001 May 28, 2002
AP INTL MEDICATED EQ 1MG BASE/ML A076013 001 Aug 02, 2002
MILRINONE LACTATE IN DEXTROSE 5%
AP APOTEX INC EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A077151 002 Jul 20, 2005
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A076414 001 Aug 18, 2004
AP + BAXTER HLTHCARE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075834 001 May 28, 2002
AP + EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A075834 002 May 28, 2002
AP BEDFORD LABS EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A078113 001 May 21, 2008
AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A078113 002 May 21, 2008
AP HOSPIRA EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075885 001 May 28, 2002
AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A075885 002 May 28, 2002
MILRINONE LACTATE IN PLASTIC CONTAINER
AP HIKMA FARMACEUTICA EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A090038 001 Jan 21, 2010
AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A090038 002 Jan 21, 2010
MINOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL
DYNACIN
AB MEDICIS EQ 75MG BASE A063067 002 Sep 15, 1999
AB EQ 100MG BASE A063067 001 Jul 31, 1990
MINOCIN
AB PRECISION DERMAT EQ 50MG BASE N050649 001 May 31, 1990
AB EQ 100MG BASE N050649 002 May 31, 1990
MINOCYCLINE HYDROCHLORIDE
AB AUROBINDO PHARMA EQ 50MG BASE A065470 001 Mar 11, 2008
AB EQ 75MG BASE A065470 002 Mar 11, 2008
AB EQ 100MG BASE A065470 003 Mar 11, 2008
AB CARACO EQ 50MG BASE A090867 001 May 13, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-246( of 362)
MINOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL
MINOCYCLINE HYDROCHLORIDE
AB EQ 75MG BASE A090867 002 May 13, 2013
AB EQ 100MG BASE A090867 003 May 13, 2013
AB IMPAX LABS EQ 50MG BASE A065005 001 Mar 23, 1999
AB EQ 75MG BASE A065005 003 Apr 18, 2001
AB EQ 100MG BASE A065005 002 Mar 23, 1999
AB RANBAXY EQ 50MG BASE A065062 001 Nov 30, 2000
AB EQ 75MG BASE A065062 002 Nov 30, 2000
AB EQ 100MG BASE A065062 003 Nov 30, 2000
AB TEVA EQ 50MG BASE A063011 001 Mar 02, 1992
AB EQ 75MG BASE A063009 002 Aug 12, 2003
AB + EQ 100MG BASE A063009 001 Mar 02, 1992
AB WATSON LABS EQ 50MG BASE A063181 001 Dec 30, 1991
AB EQ 75MG BASE A063065 002 Jun 10, 1999
AB EQ 100MG BASE A063065 001 Dec 30, 1991
INJECTABLE;INJECTION
MINOCIN
+ REMPEX PHARMS INC EQ 100MG BASE/VIAL N050444 001
POWDER, EXTENDED RELEASE;DENTAL
ARESTIN
+ ORAPHARMA EQ 1MG BASE N050781 001 Feb 16, 2001
TABLET;ORAL
MINOCYCLINE HYDROCHLORIDE
AB DR REDDYS LABS LTD EQ 50MG BASE A065436 001 Dec 26, 2007
AB EQ 75MG BASE A065436 002 Dec 26, 2007
AB EQ 100MG BASE A065436 003 Dec 26, 2007
AB PAR PHARM EQ 50MG BASE A065131 001 Apr 16, 2003
AB EQ 75MG BASE A065131 002 Apr 16, 2003
AB + EQ 100MG BASE A065131 003 Apr 16, 2003
AB RANBAXY EQ 50MG BASE A065156 001 Jan 06, 2004
AB EQ 75MG BASE A065156 002 Jan 06, 2004
AB EQ 100MG BASE A065156 003 Jan 06, 2004
TABLET, EXTENDED RELEASE;ORAL
MINOCYCLINE HYDROCHLORIDE
AB AUROBINDO PHARMA LTD EQ 45MG BASE A202261 001 Nov 19, 2012
AB EQ 90MG BASE A202261 003 Nov 19, 2012
AB EQ 135MG BASE A202261 005 Nov 19, 2012
AB BARR LABS INC EQ 45MG BASE A065485 001 Mar 17, 2009
AB EQ 65MG BASE A065485 004 May 18, 2012
AB EQ 90MG BASE A065485 002 Mar 17, 2009
AB EQ 115MG BASE A065485 005 May 18, 2012
AB EQ 135MG BASE A065485 003 Mar 17, 2009
AB IMPAX LABS INC EQ 45MG BASE A090024 001 Feb 03, 2009
AB EQ 90MG BASE A090024 002 Feb 03, 2009
AB EQ 135MG BASE A090024 003 Feb 03, 2009
AB LUPIN LTD EQ 45MG BASE A091424 001 Nov 30, 2011
AB EQ 90MG BASE A091424 003 Nov 30, 2011
AB EQ 135MG BASE A091424 004 Nov 30, 2011
AB MYLAN PHARMS INC EQ 45MG BASE A090911 001 Jul 20, 2010
AB EQ 90MG BASE A090911 002 Jul 20, 2010
AB EQ 135MG BASE A090911 003 Jul 20, 2010
AB SANDOZ EQ 45MG BASE A090422 001 Aug 13, 2009
AB EQ 90MG BASE A090422 002 Aug 13, 2009
AB EQ 135MG BASE A090422 003 Aug 13, 2009
SOLODYN
AB MEDICIS EQ 65MG BASE N050808 004 Jul 23, 2009
AB EQ 115MG BASE N050808 005 Jul 23, 2009
+ EQ 55MG BASE N050808 008 Aug 27, 2010
+ EQ 80MG BASE N050808 007 Aug 27, 2010
EQ 105MG BASE N050808 006 Aug 27, 2010
MINOXIDIL
TABLET;ORAL
MINOXIDIL
AB MUTUAL PHARM 2.5MG A072708 001 Dec 14, 1995
AB 10MG A072709 001 Dec 14, 1995
AB PAR PHARM 2.5MG A071826 001 Nov 14, 1988
AB 10MG A071839 001 Nov 14, 1988
AB WATSON LABS 2.5MG A071344 001 Mar 03, 1987
AB + 10MG A071345 001 Mar 03, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-247( of 362)
MIPOMERSEN SODIUM
SOLUTION;SUBCUTANEOUS
KYNAMRO
+ GENZYME CORP 200MG/ML (200MG/ML) N203568 001 Jan 29, 2013
MIRABEGRON
TABLET, EXTENDED RELEASE;ORAL
MYRBETRIQ
APGDI 25MG N202611 001 Jun 28, 2012
+ 50MG N202611 002 Jun 28, 2012
MIRTAZAPINE
TABLET;ORAL
MIRTAZAPINE
AB APOTEX INC 15MG A077666 001 Aug 22, 2007
AB 30MG A077666 002 Aug 22, 2007
AB 45MG A077666 003 Aug 22, 2007
AB AUROBINDO 7.5MG A076921 001 Oct 22, 2004
AB 15MG A076921 002 Oct 22, 2004
AB 30MG A076921 003 Oct 22, 2004
AB 45MG A076921 004 Oct 22, 2004
AB CARACO 7.5MG A076541 004 Apr 22, 2004
AB 15MG A076541 001 Apr 22, 2004
AB 30MG A076541 002 Apr 22, 2004
AB 45MG A076541 003 Apr 22, 2004
AB MYLAN 15MG A076122 001 Jun 19, 2003
AB 30MG A076122 002 Jun 19, 2003
AB 45MG A076122 003 Jun 19, 2003
AB MYLAN PHARMS INC 15MG A076176 001 Jun 19, 2003
AB 30MG A076176 002 Jun 19, 2003
AB 45MG A076176 003 Jun 19, 2003
AB SANDOZ 15MG A076219 001 Jun 19, 2003
AB 30MG A076219 002 Jun 19, 2003
AB 45MG A076219 003 Jun 19, 2003
AB TEVA 15MG A076119 001 Jan 24, 2003
AB 30MG A076119 002 Jan 24, 2003
AB 45MG A076119 003 Jun 19, 2003
AB WATSON LABS 15MG A076312 001 Jun 19, 2003
AB 30MG A076312 002 Jun 19, 2003
AB 45MG A076312 003 Jun 19, 2003
AB WATSON LABS FLORIDA 15MG A076336 001 Jun 20, 2003
AB 30MG A076336 002 Jun 20, 2003
AB 45MG A076336 003 Jun 20, 2003
REMERON
AB + ORGANON USA INC 15MG N020415 001 Jun 14, 1996
AB 30MG N020415 002 Jun 14, 1996
AB 45MG N020415 003 Mar 17, 1997
TABLET, ORALLY DISINTEGRATING;ORAL
MIRTAZAPINE
AB AUROBINDO PHARMA LTD 15MG A077376 002 Dec 08, 2005
AB 30MG A077376 003 Dec 08, 2005
AB 45MG A077376 004 Feb 28, 2006
AB TEVA 15MG A076901 001 Jun 28, 2005
AB 30MG A076901 002 Jun 28, 2005
AB 45MG A076901 003 Jun 28, 2005
AB WATSON LABS 15MG A076307 001 Dec 17, 2003
AB 30MG A076307 002 Dec 17, 2003
AB 45MG A076307 003 Feb 28, 2006
REMERON SOLTAB
AB + ORGANON USA INC 15MG N021208 001 Jan 12, 2001
AB 30MG N021208 002 Jan 12, 2001
AB 45MG N021208 003 Jan 12, 2001
MISOPROSTOL
TABLET;ORAL
CYTOTEC
AB GD SEARLE LLC 0.1MG N019268 003 Sep 21, 1990
AB + 0.2MG N019268 001 Dec 27, 1988
MISOPROSTOL
AB IVAX SUB TEVA PHARMS 0.1MG A076095 001 Jul 10, 2002
AB 0.2MG A076095 002 Jul 10, 2002
AB NOVEL LABS INC 0.1MG A091667 001 Jul 25, 2012
AB 0.2MG A091667 002 Jul 25, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-248( of 362)
MITOMYCIN
FOR SOLUTION;TOPICAL
MITOSOL
+ MOBIUS THERAP 0.2MG/VIAL N022572 001 Feb 07, 2012
INJECTABLE;INJECTION
MITOMYCIN
AP + ACCORD HLTHCARE 5MG/VIAL A064144 001 Apr 30, 1998
AP + 20MG/VIAL A064144 002 Apr 30, 1998
AP + 40MG/VIAL A064144 003 Aug 11, 2009
AP BEDFORD 5MG/VIAL A064117 001 Apr 19, 1995
AP 20MG/VIAL A064117 002 Apr 19, 1995
AP HIKMA MAPLE 5MG/VIAL A064180 001 Dec 23, 1999
AP 20MG/VIAL A064180 002 Dec 23, 1999
MITOTANE
TABLET;ORAL
LYSODREN
+ BRISTOL MYERS SQUIBB 500MG N016885 001
MITOXANTRONE HYDROCHLORIDE
INJECTABLE;INJECTION
MITOXANTRONE HYDROCHLORIDE
AP BEDFORD EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A076611 001 Apr 11, 2006
AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A076611 002 Apr 11, 2006
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A076611 003 Apr 11, 2006
AP FRESENIUS KABI USA EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A077496 001 Apr 11, 2006
AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A077496 002 Apr 11, 2006
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A077496 003 Apr 11, 2006
AP + HOSPIRA EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A076871 001 Apr 11, 2006
AP + EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A076871 002 Apr 11, 2006
AP + EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A076871 003 Apr 11, 2006
AP MYLAN INSTITUTIONAL EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A078980 001 Apr 13, 2009
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A078980 002 Apr 13, 2009
AP ONCO THERAPIES LTD EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A201014 001 Dec 11, 2012
AP TEVA PHARMS USA EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A077356 001 Apr 11, 2006
AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A077356 002 Apr 11, 2006
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A077356 003 Apr 11, 2006
MODAFINIL
TABLET;ORAL
MODAFINIL
AB ALEMBIC LTD 100MG A202700 001 Oct 18, 2012
AB 200MG A202700 002 Oct 18, 2012
AB AUROBINDO PHARMA LTD 100MG A202566 001 Sep 27, 2012
AB 200MG A202566 002 Sep 27, 2012
AB CARLSBAD 100MG A076715 001 Nov 01, 2012
AB 200MG A076715 002 Nov 01, 2012
AB HIKMA PHARMS 100MG A090543 001 Sep 26, 2012
AB 200MG A090543 002 Sep 26, 2012
AB MYLAN PHARMS INC 100MG A076594 001 Jul 16, 2012
AB 200MG A076594 002 Jul 16, 2012
AB ORCHID HLTHCARE 100MG A078963 001 Sep 26, 2012
AB 200MG A078963 002 Sep 26, 2012
PROVIGIL
AB CEPHALON 100MG N020717 001 Dec 24, 1998
AB + 200MG N020717 002 Dec 24, 1998
MOEXIPRIL HYDROCHLORIDE
TABLET;ORAL
MOEXIPRIL HYDROCHLORIDE
AB APOTEX INC 7.5MG A078454 001 Jun 02, 2008
AB 15MG A078454 002 Jun 02, 2008
AB GLENMARK GENERICS 7.5MG A090416 001 Mar 30, 2010
AB 15MG A090416 002 Mar 30, 2010
AB PADDOCK LLC 7.5MG A077536 001 Nov 30, 2006
AB 15MG A077536 002 Nov 30, 2006
AB TEVA 7.5MG A076204 001 May 08, 2003
AB 15MG A076204 002 May 08, 2003
UNIVASC
AB UCB INC 7.5MG N020312 001 Apr 19, 1995
AB + 15MG N020312 002 Apr 19, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-249( of 362)
MOMETASONE FUROATE
CREAM;TOPICAL
ELOCON
AB + MERCK SHARP DOHME 0.1% N019625 001 May 06, 1987
AB 0.1% N019625 002 Apr 19, 2013
MOMETASONE FUROATE
AB FOUGERA PHARMS 0.1% A076171 001 Apr 08, 2005
AB G AND W LABS 0.1% A077447 001 May 22, 2006
AB GLENMARK GENERICS 0.1% A078541 001 May 28, 2008
AB TARO 0.1% A076679 001 Dec 21, 2004
AB TOLMAR 0.1% A076591 001 Apr 18, 2007
LOTION;TOPICAL
ELOCON
AB + MERCK SHARP DOHME 0.1% N019796 001 Mar 30, 1989
MOMETASONE FUROATE
AB FOUGERA PHARMS 0.1% A075919 001 Nov 29, 2007
AB G AND W LABS 0.1% A077678 001 Nov 21, 2007
AB GLENMARK GENERICS 0.1% A090506 001 Aug 09, 2010
AB PERRIGO 0.1% A077180 001 Apr 06, 2005
AB TARO 0.1% A076788 001 Mar 15, 2006
AB TOLMAR 0.1% A076499 001 Nov 21, 2007
OINTMENT;TOPICAL
ELOCON
AB + MERCK SHARP DOHME 0.1% N019543 001 Apr 30, 1987
MOMETASONE FUROATE
AB FOUGERA PHARMS 0.1% A077061 001 Mar 28, 2005
AB G AND W LABS 0.1% A077401 001 Jun 20, 2006
AB GLENMARK GENERICS 0.1% A078571 001 May 28, 2008
AB PERRIGO NEW YORK 0.1% A076067 001 Mar 18, 2002
AB TOLMAR 0.1% A076481 001 Nov 14, 2003
POWDER;INHALATION
ASMANEX TWISTHALER
SCHERING 0.11MG/INH N021067 002 Feb 01, 2008
+ 0.22MG/INH N021067 001 Mar 30, 2005
MOMETASONE FUROATE MONOHYDRATE
SPRAY, METERED;NASAL
NASONEX
+ SCHERING PLOUGH EQ 0.05MG BASE/SPRAY N020762 001 Oct 01, 1997
MONTELUKAST SODIUM
GRANULE;ORAL
MONTELUKAST SODIUM
AB DR REDDYS LABS LTD EQ 4MG BASE/PACKET A202906 001 Sep 17, 2012
AB MYLAN PHARMS INC EQ 4MG BASE/PACKET A202776 001 Dec 18, 2012
AB TEVA PHARMS EQ 4MG BASE/PACKET A090955 001 Aug 03, 2012
SINGULAIR
AB + MERCK EQ 4MG BASE/PACKET N021409 001 Jul 26, 2002
TABLET;ORAL
MONTELUKAST SODIUM
AB ACCORD HLTHCARE EQ 10MG BASE A202717 001 Sep 21, 2012
AB APOTEX CORP EQ 10MG BASE A201294 001 Aug 03, 2012
AB AUROBINDO PHARMA LTD EQ 10MG BASE A202468 001 Aug 03, 2012
AB DR REDDYS LABS LTD EQ 10MG BASE A201582 001 Aug 06, 2012
AB GLENMARK GENERICS EQ 10MG BASE A090926 001 Aug 03, 2012
AB KUDCO IRELAND EQ 10MG BASE A201522 001 Aug 03, 2012
AB MYLAN PHARMS INC EQ 10MG BASE A079103 001 Aug 03, 2012
AB ROXANE EQ 10MG BASE A090655 001 Aug 03, 2012
AB SANDOZ INC EQ 10MG BASE A200889 001 Aug 03, 2012
AB TEVA PHARMS EQ 10MG BASE A078605 001 Aug 03, 2012
AB TORRENT PHARMS LTD EQ 10MG BASE A201515 001 Aug 03, 2012
AB VINTAGE PHARMS LLC EQ 10MG BASE A091576 001 Aug 03, 2012
SINGULAIR
AB + MERCK EQ 10MG BASE N020829 002 Feb 20, 1998
TABLET, CHEWABLE;ORAL
MONTELUKAST SODIUM
AB APOTEX INC EQ 4MG BASE A201508 001 Aug 03, 2012
AB EQ 5MG BASE A201508 002 Aug 03, 2012
AB AUROBINDO PHARMA LTD EQ 4MG BASE A202096 001 Aug 03, 2012
AB EQ 5MG BASE A202096 002 Aug 03, 2012
AB DR REDDYS LABS LTD EQ 4MG BASE A201581 001 Aug 06, 2012
AB EQ 5MG BASE A201581 002 Aug 06, 2012
AB KUDCO IRELAND EQ 4MG BASE A200405 001 Aug 03, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-250( of 362)
MONTELUKAST SODIUM
TABLET, CHEWABLE;ORAL
MONTELUKAST SODIUM
AB EQ 5MG BASE A200405 002 Aug 03, 2012
AB MYLAN PHARMS INC EQ 4MG BASE A079142 001 Aug 03, 2012
AB EQ 5MG BASE A079142 002 Aug 03, 2012
AB ROXANE EQ 4MG BASE A091128 001 Aug 03, 2012
AB EQ 5MG BASE A091128 002 Aug 03, 2012
AB SANDOZ INC EQ 4MG BASE A091414 001 Aug 03, 2012
AB EQ 5MG BASE A091414 002 Aug 03, 2012
AB TEVA PHARMS EQ 4MG BASE A078723 001 Aug 03, 2012
AB EQ 5MG BASE A078723 002 Aug 03, 2012
AB TORRENT PHARMS LTD EQ 4MG BASE A090984 001 Aug 03, 2012
AB EQ 5MG BASE A090984 002 Aug 03, 2012
AB VINTAGE PHARMS LLC EQ 4MG BASE A091588 001 Aug 03, 2012
AB EQ 5MG BASE A091588 002 Aug 03, 2012
SINGULAIR
AB MERCK EQ 4MG BASE N020830 002 Mar 03, 2000
AB + EQ 5MG BASE N020830 001 Feb 20, 1998
MORPHINE SULFATE
CAPSULE, EXTENDED RELEASE;ORAL
KADIAN
AB1 + WATSON LABS INC 10MG N020616 008 Apr 20, 2007
AB1 20MG N020616 001 Jul 03, 1996
AB1 30MG N020616 004 Mar 09, 2001
AB1 50MG N020616 002 Jul 03, 1996
AB1 60MG N020616 005 Mar 09, 2001
AB1 80MG N020616 006 Oct 27, 2006
AB1 + 100MG N020616 003 Jul 03, 1996
AB1 + 200MG N020616 007 Feb 27, 2007
MORPHINE SULFATE
AB1 PAR PHARM INC 20MG A200812 001 Nov 10, 2011
AB1 30MG A200812 002 Nov 10, 2011
AB1 50MG A200812 003 Nov 10, 2011
AB1 60MG A200812 004 Nov 10, 2011
AB1 80MG A200812 005 Nov 10, 2011
AB1 100MG A200812 006 Nov 10, 2011
AB1 UPSHER SMITH 10MG A202104 001 Jun 03, 2013
AB1 20MG A202104 002 Jun 03, 2013
AB1 30MG A202104 003 Jun 03, 2013
AB1 50MG A202104 004 Jun 03, 2013
AB1 60MG A202104 005 Jun 03, 2013
AB1 80MG A202104 006 Jun 03, 2013
AB1 100MG A202104 007 Jun 03, 2013
AVINZA
AB2 KING PFIZER 30MG N021260 001 Mar 20, 2002
AB2 45MG N021260 005 Dec 18, 2008
AB2 60MG N021260 002 Mar 20, 2002
AB2 75MG N021260 006 Dec 18, 2008
AB2 90MG N021260 003 Mar 20, 2002
AB2 + 120MG N021260 004 Mar 20, 2002
MORPHINE SULFATE
AB2 ACTAVIS ELIZABETH 30MG A079040 001 Jan 16, 2013
AB2 45MG A079040 002 Jan 16, 2013
AB2 60MG A079040 003 Jan 16, 2013
AB2 75MG A079040 004 Jan 16, 2013
AB2 90MG A079040 005 Jan 16, 2013
AB2 120MG A079040 006 Jan 16, 2013
KADIAN
WATSON LABS INC 40MG N020616 009 Jul 09, 2012
70MG N020616 010 Jul 09, 2012
130MG N020616 011 Jul 09, 2012
150MG N020616 012 Jul 09, 2012
INJECTABLE;INJECTION
ASTRAMORPH PF
AP FRESENIUS KABI USA 0.5MG/ML A071050 001 Oct 07, 1986
AP 0.5MG/ML A071051 001 Oct 07, 1986
AP 1MG/ML A071052 001 Oct 07, 1986
AP 1MG/ML A071053 001 Oct 07, 1986
DURAMORPH PF
AP + HIKMA MAPLE 0.5MG/ML N018565 001 Sep 18, 1984
AP + 1MG/ML N018565 002 Sep 18, 1984
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-251( of 362)
MORPHINE SULFATE
INJECTABLE;INJECTION
MORPHINE SULFATE
AP HOSPIRA 0.5MG/ML A071849 001 May 11, 1988
AP 0.5MG/ML A073509 001 Sep 30, 1992
AP 1MG/ML A071850 001 May 11, 1988
AP 1MG/ML A073510 001 Sep 30, 1992
AP + 1MG/ML N019916 001 Oct 30, 1992
AP WATSON LABS 0.5MG/ML A073373 001 Sep 30, 1991
AP 0.5MG/ML A073375 001 Sep 30, 1991
AP 1MG/ML A073374 001 Sep 30, 1991
AP 1MG/ML A073376 001 Sep 30, 1991
INFUMORPH
+ HIKMA MAPLE 10MG/ML N018565 003 Jul 19, 1991
+ 25MG/ML N018565 004 Jul 19, 1991
MORPHINE SULFATE
+ HOSPIRA 5MG/ML N019916 002 Oct 27, 2006
+ HOSPIRA INC 2MG/ML N202515 001 Nov 14, 2011
+ 4MG/ML N202515 002 Nov 14, 2011
+ 8MG/ML N202515 003 Nov 14, 2011
+ 10MG/ML N202515 004 Nov 14, 2011
+ 15MG/ML N202515 005 Nov 14, 2011
+ MERIDIAN MEDCL TECHN 15MG/ML N019999 001 Jul 12, 1990
SOLUTION;IM-IV
MORPHINE SULFATE
+ BD RX 2MG/ML (2MG/ML) N204223 001 Oct 30, 2013
+ 4MG/ML (4MG/ML) N204223 002 Oct 30, 2013
+ 5MG/ML (5MG/ML) N204223 003 Oct 30, 2013
+ 8MG/ML (8MG/ML) N204223 004 Oct 30, 2013
+ 10MG/ML (10MG/ML) N204223 005 Oct 30, 2013
SOLUTION;ORAL
MORPHINE SULFATE
AA MALLINCKRODT INC 100MG/5ML A202348 001 Jul 15, 2011
AA PADDOCK LLC 100MG/5ML A201574 001 Aug 06, 2012
AA ROXANE 10MG/5ML N022195 001 Mar 17, 2008
AA 20MG/5ML N022195 002 Mar 17, 2008
AA + 100MG/5ML N022195 003 Jan 25, 2010
AA VISTAPHARM 10MG/5ML A201947 001 Jan 05, 2012
AA 20MG/5ML A201947 002 Jan 05, 2012
LANNETT HOLDINGS INC 100MG/5ML N201517 001 Jun 23, 2011
TABLET;ORAL
MORPHINE SULFATE
ROXANE 15MG N022207 001 Mar 17, 2008
+ 30MG N022207 002 Mar 17, 2008
TABLET, EXTENDED RELEASE;ORAL
MORPHINE SULFATE
AB CLONMEL HLTHCARE 15MG A075407 001 Jan 28, 2000
AB MALLINCKRODT 15MG A076412 001 Jul 31, 2003
AB 30MG A076412 002 Jul 31, 2003
AB 60MG A076412 003 Jul 31, 2003
AB 100MG A076438 001 Jul 03, 2003
AB 200MG A076438 002 Jul 03, 2003
AB MYLAN PHARMS INC 15MG A200824 001 Oct 18, 2011
AB 30MG A200824 002 Oct 18, 2011
AB 60MG A200824 003 Oct 18, 2011
AB 100MG A200824 004 Oct 18, 2011
AB 200MG A200824 005 Oct 18, 2011
AB NESHER PHARMS 15MG A076733 001 May 19, 2004
AB 30MG A076720 002 Dec 23, 2005
AB 60MG A076720 001 May 19, 2004
AB 100MG A077855 001 Sep 27, 2007
AB 200MG A077855 002 Sep 27, 2007
AB RANBAXY LABS LTD 15MG A078761 001 May 11, 2012
AB 30MG A078761 002 May 11, 2012
AB 60MG A078761 003 May 11, 2012
AB 100MG A078761 004 May 11, 2012
AB 200MG A078761 005 May 11, 2012
AB RHODES PHARMS 15MG A074862 001 Jul 07, 1998
AB 30MG A074862 002 Jul 07, 1998
AB 60MG A074862 003 Jul 07, 1998
AB 100MG A074769 001 Jul 02, 1998
AB 200MG A074769 002 Jul 02, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-252( of 362)
MORPHINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
MORPHINE SULFATE
AB VINTAGE PHARMS LLC 15MG A075295 001 Oct 28, 1998
AB 30MG A075295 002 Oct 28, 1998
AB 60MG A075295 003 Oct 28, 1998
AB 100MG A075295 004 Sep 15, 2000
AB 200MG A075295 005 Sep 15, 2000
MS CONTIN
AB PURDUE PHARMA LP 15MG N019516 003 Sep 12, 1989
AB 30MG N019516 001 May 29, 1987
AB 60MG N019516 002 Apr 08, 1988
AB + 100MG N019516 004 Jan 16, 1990
AB 200MG N019516 005 Nov 08, 1993
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
EMBEDA
ALPHARMA KING 20MG;0.8MG N022321 001 Aug 13, 2009
30MG;1.2MG N022321 002 Aug 13, 2009
50MG;2MG N022321 003 Aug 13, 2009
+ 60MG;2.4MG N022321 004 Aug 13, 2009
80MG;3.2MG N022321 005 Aug 13, 2009
100MG;4MG N022321 006 Aug 13, 2009
MOXIFLOXACIN HYDROCHLORIDE
INJECTABLE;IV (INFUSION)
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
+ BAYER HLTHCARE 160MG/100ML N021277 001 Nov 30, 2001
SOLUTION/DROPS;OPHTHALMIC
MOXEZA
+ ALCON PHARMS LTD EQ 0.5% BASE N022428 001 Nov 19, 2010
VIGAMOX
+ ALCON PHARMS LTD EQ 0.5% BASE N021598 001 Apr 15, 2003
TABLET;ORAL
AVELOX
+ BAYER HLTHCARE EQ 400MG BASE N021085 001 Dec 10, 1999
MUPIROCIN
OINTMENT;TOPICAL
BACTROBAN
AB + GLAXOSMITHKLINE 2% N050591 001 Dec 31, 1987
MUPIROCIN
AB FOUGERA PHARMS 2% A065192 001 Nov 30, 2005
AB GLENMARK PHARMS 2% A090480 001 Jun 08, 2011
AB PERRIGO NEW YORK 2% A065123 001 Nov 07, 2003
AB TARO 2% A065170 001 Sep 23, 2005
AB TEVA 2% A065085 001 Nov 07, 2003
CENTANY
BX PERRIGO NEW YORK 2% N050788 001 Dec 04, 2002
MUPIROCIN CALCIUM
CREAM;TOPICAL
BACTROBAN
AB + GLAXOSMITHKLINE EQ 2% BASE N050746 001 Dec 11, 1997
MUPIROCIN
AB GLENMARK GENERICS EQ 2% BASE A201587 001 Jan 24, 2013
OINTMENT;NASAL
BACTROBAN
+ GLAXOSMITHKLINE EQ 2% BASE N050703 001 Sep 18, 1995
MYCOPHENOLATE MOFETIL
CAPSULE;ORAL
CELLCEPT
AB + ROCHE PALO 250MG N050722 001 May 03, 1995
MYCOPHENOLATE MOFETIL
AB ACCORD HLTHCARE 250MG A090253 001 May 04, 2009
AB ALKEM LABS LTD 250MG A200197 001 Jun 13, 2013
AB APOTEX CORP 250MG A090419 001 Apr 22, 2009
AB DR REDDYS LABS LTD 250MG A091315 001 Oct 27, 2011
AB MYLAN 250MG A065520 001 May 04, 2009
AB ROXANE 250MG A065410 001 Jul 29, 2008
AB SANDOZ 250MG A065379 001 Oct 15, 2008
AB STRIDES ARCOLAB LTD 250MG A090055 001 Jun 10, 2010
AB TEVA PHARMS 250MG A065491 001 May 06, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
MYCOPHENOLATE MOFETIL
CAPSULE;ORAL
MYCOPHENOLATE MOFETIL
AB VINTAGE PHARMS LLC
SUSPENSION;ORAL
CELLCEPT
+ ROCHE PALO
TABLET;ORAL
CELLCEPT
AB + ROCHE PALO
MYCOPHENOLATE MOFETIL
AB ACCORD HLTHCARE
AB ALKEM LABS LTD
AB APOTEX
AB MYLAN
AB ROXANE
AB SANDOZ
AB STRIDES ARCOLAB LTD
AB TEVA PHARMS
AB VINTAGE PHARMS LLC
250MG
200MG/ML
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
INJECTABLE;INJECTION
CELLCEPT
+ ROCHE PALO
MYCOPHENOLIC ACID
TABLET, DELAYED RELEASE;ORAL
MYCOPHENOLIC ACID
AB APOTEX INC
AB MYLAN PHARMS INC
AB
MYFORTIC
AB NOVARTIS
AB +
NABILONE
CAPSULE;ORAL
CESAMET
+ MEDA PHARMS
NABUMETONE
TABLET;ORAL
NABUMETONE
AB APOTEX INC
AB
AB INVAGEN PHARMS
AB
AB LUPIN LTD
AB
AB MYLAN PHARMS INC
AB
AB PAR PHARM
AB
AB SANDOZ
AB
AB TEVA
AB +
AB WATSON LABS
AB
NADOLOL
TABLET;ORAL
CORGARD
AB KING PHARMS
AB
AB +
NADOLOL
AB IVAX SUB TEVA PHARMS
AB
AB
AB MYLAN
AB
AB
AB SANDOZ
500MG/VIAL
180MG
180MG
360MG
180MG
360MG
1MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
3-253( of 362)
A090111 001 Dec 22, 2009
N050759 001 Oct 01, 1998
N050723 001 Jun 19, 1997
A065416 001 May 04, 2009
A091249 001 Nov 04, 2011
A090499 001 Apr 22, 2009
A065521 001 May 04, 2009
A065413 001 Jul 29, 2008
A065451 001 Oct 15, 2008
A090456 001 Jun 10, 2010
A065457 001 May 04, 2009
A090606 001 Jul 16, 2010
N050758 001 Aug 12, 1998
A091558 001 Aug 21, 2012
A091248 002 Jan 08, 2014
A091248 001 Jan 08, 2014
N050791 001 Feb 27, 2004
N050791 002 Feb 27, 2004
N018677 001 Dec 26, 1985
A090427 001 Dec 30, 2011
A090427 002 Dec 30, 2011
A078671 001 Mar 07, 2008
A078671 002 Mar 07, 2008
A090445 001 Jan 12, 2011
A090445 002 Jan 12, 2011
A090516 001 Jul 12, 2010
A090516 002 Jul 12, 2010
A076009 001 Jan 24, 2003
A076009 002 Jan 24, 2003
A075280 001 Feb 25, 2002
A075280 002 Feb 25, 2002
A075189 001 May 26, 2000
A075189 002 Sep 24, 2001
A091083 001 Jun 13, 2011
A091083 002 Jun 13, 2011
N018063 005 Oct 28, 1986
N018063 001
N018063 002
A074229 001 Aug 30, 1996
A074229 002 Aug 30, 1996
A074255 001 Jan 24, 1996
A074172 001 Oct 31, 1993
A074172 002 Oct 31, 1993
A074172 003 Oct 31, 1993
A074501 001 Nov 09, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-254( of 362)
NADOLOL
TABLET;ORAL
NADOLOL
AB 40MG A074501 002 Nov 09, 1995
AB 80MG A074501 003 Nov 09, 1995
NAFARELIN ACETATE
SPRAY, METERED;NASAL
SYNAREL
+ GD SEARLE LLC EQ 0.2MG BASE/SPRAY N019886 001 Feb 13, 1990
NAFCILLIN SODIUM
INJECTABLE;INJECTION
NAFCILLIN SODIUM
AP ANTIBIOTICE EQ 1GM BASE A090560 001 Oct 03, 2011
AP EQ 2GM BASE A090560 002 Oct 03, 2011
AP AUROBINDO PHARMA LTD EQ 1GM BASE/VIAL A091613 001 Dec 26, 2012
AP EQ 2GM BASE/VIAL A091613 002 Dec 26, 2012
AP EQ 10GM BASE/VIAL A091614 001 Dec 26, 2012
AP IBI EQ 1GM BASE/VIAL A090002 001 Jun 30, 2011
AP EQ 2GM BASE/VIAL A090002 002 Jun 30, 2011
AP EQ 10GM BASE/VIAL A090005 001 Apr 20, 2011
AP SAGENT PHARMS EQ 1GM BASE/VIAL A090582 001 Aug 24, 2012
AP EQ 2GM BASE/VIAL A090582 002 Aug 24, 2012
AP EQ 10GM BASE/VIAL A090580 001 Aug 24, 2012
AP + SANDOZ EQ 1GM BASE/VIAL A062527 002 Aug 02, 1984
AP + EQ 1GM BASE/VIAL A062732 001 Dec 23, 1986
AP + EQ 2GM BASE/VIAL A062527 003 Aug 02, 1984
AP + EQ 2GM BASE/VIAL A062732 002 Dec 23, 1986
AP + EQ 10GM BASE/VIAL A062527 004 Aug 02, 1984
NALLPEN IN PLASTIC CONTAINER
+ BAXTER HLTHCARE EQ 2GM BASE/100ML N050655 002 Oct 31, 1989
+ EQ 20MG BASE/ML N050655 001 Oct 31, 1989
NAFTIFINE HYDROCHLORIDE
CREAM;TOPICAL
NAFTIN
+ MERZ PHARMS 1% N019599 001 Feb 29, 1988
+ 2% N019599 002 Jan 13, 2012
GEL;TOPICAL
NAFTIN
+ MERZ PHARMS 1% N019356 001 Jun 18, 1990
+ 2% N204286 001 Jun 27, 2013
NALBUPHINE HYDROCHLORIDE
INJECTABLE;INJECTION
NALBUPHINE HYDROCHLORIDE
AP + HOSPIRA 10MG/ML A070914 001 Feb 03, 1989
AP + 10MG/ML A070915 001 Feb 03, 1989
AP + 20MG/ML A070916 001 Feb 03, 1989
AP + 20MG/ML A070918 001 Feb 03, 1989
NALOXONE HYDROCHLORIDE
INJECTABLE;INJECTION
NALOXONE HYDROCHLORIDE
AP + HOSPIRA 0.4MG/ML A070172 001 Sep 24, 1986
AP + 0.4MG/ML A070254 001 Jan 07, 1987
AP + 0.4MG/ML A070256 001 Jan 07, 1987
AP + 0.4MG/ML A070257 001 Jan 07, 1987
AP INTL MEDICATION 0.4MG/ML A070639 001 Sep 24, 1986
AP + 1MG/ML A072076 001 Mar 24, 1988
NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
AB GAVIS PHARMS EQ 0.5MG BASE;EQ 50MG BASE A075735 001 Jul 11, 2001
AB RANBAXY EQ 0.5MG BASE;EQ 50MG BASE A075523 001 Mar 17, 2000
AB + WATSON LABS EQ 0.5MG BASE;EQ 50MG BASE A074736 001 Jan 21, 1997
NALTREXONE
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
VIVITROL
+ ALKERMES 380MG/VIAL N021897 001 Apr 13, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-255( of 362)
NALTREXONE HYDROCHLORIDE
TABLET;ORAL
NALTREXONE HYDROCHLORIDE
AB ACCORD HLTHCARE 50MG A091205 001 Aug 17, 2011
AB BARR 50MG A074918 001 May 08, 1998
AB ELITE LABS 50MG A075274 001 May 26, 1999
AB MALLINCKRODT 50MG A076264 002 Mar 22, 2002
AB SUN PHARMA GLOBAL 50MG A090356 001 Feb 24, 2012
REVIA
AB + TEVA WOMENS 50MG N018932 001 Nov 20, 1984
NALTREXONE HYDROCHLORIDE
MALLINCKRODT 25MG A076264 001 Mar 22, 2002
100MG A076264 003 Mar 22, 2002
NANDROLONE DECANOATE
INJECTABLE;INJECTION
NANDROLONE DECANOATE
+ PHARMAFORCE 200MG/ML A091252 001 Aug 30, 2010
NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
ALBALON
AT + ALLERGAN 0.1% A080248 001
NAPHAZOLINE HYDROCHLORIDE
AT AKORN INC 0.1% A083590 001
NAPROXEN
SUSPENSION;ORAL
NAPROSYN
AB + ROCHE PALO 25MG/ML N018965 001 Mar 23, 1987
NAPROXEN
AB ROXANE 25MG/ML A074190 001 Mar 30, 1994
TABLET;ORAL
NAPROSYN
AB ROCHE PALO 250MG N017581 002
AB 375MG N017581 003
AB + 500MG N017581 004 Apr 15, 1982
NAPROXEN
AB AMNEAL PHARMS NY 250MG A075927 001 Dec 18, 2001
AB 375MG A075927 002 Dec 18, 2001
AB 500MG A075927 003 Dec 18, 2001
AB AUROBINDO PHARMA USA 250MG A200429 001 Nov 08, 2011
AB 375MG A200429 002 Nov 08, 2011
AB 500MG A200429 003 Nov 08, 2011
AB DAVA PHARMS INC 250MG A074410 001 Apr 28, 1995
AB 375MG A074410 002 Apr 28, 1995
AB 500MG A074410 003 Apr 28, 1995
AB GLENMARK GENERICS 250MG A078250 001 Mar 28, 2007
AB 375MG A078250 002 Mar 28, 2007
AB 500MG A078250 003 Mar 28, 2007
AB INVAGEN PHARMS 250MG A091305 001 Aug 24, 2011
AB 375MG A091305 002 Aug 24, 2011
AB 500MG A091305 003 Aug 24, 2011
AB MARKSANS PHARMA 250MG A091416 001 Feb 14, 2011
AB 375MG A091416 002 Feb 14, 2011
AB 500MG A091416 003 Feb 14, 2011
AB MYLAN 250MG A074121 001 Dec 21, 1993
AB 375MG A074121 002 Dec 21, 1993
AB 500MG A074121 003 Dec 21, 1993
AB PERRIGO R AND D 250MG A077339 001 Apr 27, 2005
AB 375MG A077339 002 Apr 27, 2005
AB 500MG A077339 003 Apr 27, 2005
AB SANDOZ 250MG A074140 001 Dec 21, 1993
AB 375MG A074140 002 Dec 21, 1993
AB 500MG A074140 003 Dec 21, 1993
AB TEVA 250MG A074201 001 Dec 21, 1993
AB 375MG A074201 002 Dec 21, 1993
AB 500MG A074201 003 Dec 21, 1993
AB WATSON LABS 250MG A074457 001 May 31, 1995
AB 375MG A074457 002 May 31, 1995
AB 500MG A074457 003 May 31, 1995
AB WEST WARD PHARM CORP 250MG A076494 001 Jan 14, 2004
AB 375MG A076494 002 Jan 14, 2004
AB 500MG A076494 003 Jan 14, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-256( of 362)
NAPROXEN
TABLET;ORAL
NAPROXEN
AB ZYDUS PHARMS USA 250MG A078620 001 Jun 07, 2007
AB 375MG A078620 002 Jun 07, 2007
AB 500MG A078620 003 Jun 07, 2007
TABLET, DELAYED RELEASE;ORAL
EC-NAPROSYN
AB + ROCHE PALO 375MG N020067 002 Oct 14, 1994
AB + 500MG N020067 003 Oct 14, 1994
NAPROXEN
AB INVAGEN PHARMS 375MG A091432 001 Sep 19, 2011
AB 500MG A091432 002 Sep 19, 2011
AB MYLAN PHARMS INC 375MG A075390 001 Apr 19, 2001
AB 500MG A075390 002 Apr 19, 2001
AB PLIVA 375MG A075337 001 May 26, 1999
AB 500MG A075337 002 May 26, 1999
AB SANDOZ 375MG A075061 001 Feb 18, 1998
AB 500MG A075061 002 Feb 18, 1998
AB TEVA 375MG A075227 001 Jun 30, 1998
AB 500MG A075227 002 Jun 30, 1998
NAPROXEN SODIUM
TABLET;ORAL
ANAPROX
AB HOFFMANN LA ROCHE EQ 250MG BASE N018164 001
ANAPROX DS
AB + HOFFMANN LA ROCHE EQ 500MG BASE N018164 003 Sep 30, 1987
NAPROXEN SODIUM
AB AMNEAL PHARMS NY EQ 250MG BASE A078432 001 Apr 25, 2007
AB EQ 500MG BASE A078432 002 Apr 25, 2007
AB AUROBINDO PHARMA LTD EQ 250MG BASE A200629 001 Oct 31, 2011
AB EQ 500MG BASE A200629 002 Oct 31, 2011
AB DR REDDYS LABS LTD EQ 250MG BASE A078486 001 Jul 26, 2007
AB EQ 500MG BASE A078486 002 Jul 26, 2007
AB GLENMARK GENERICS EQ 250MG BASE A078314 001 Apr 27, 2007
AB EQ 500MG BASE A078314 002 Apr 27, 2007
AB HIKMA EQ 250MG BASE A074480 002 Feb 18, 1998
AB EQ 500MG BASE A074480 001 May 14, 1996
AB TEVA EQ 250MG BASE A074198 001 Dec 21, 1993
AB EQ 500MG BASE A074198 002 Dec 21, 1993
AB WATSON LABS EQ 250MG BASE A074455 001 May 31, 1995
AB EQ 500MG BASE A074455 002 May 31, 1995
TABLET, EXTENDED RELEASE;ORAL
NAPRELAN
ALMATICA PHARMA INC EQ 375MG BASE N020353 001 Jan 05, 1996
EQ 500MG BASE N020353 002 Jan 05, 1996
+ EQ 750MG BASE N020353 003 Jan 05, 1996
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
TABLET;ORAL
TREXIMET
+ SMITHKLINE BEECHAM 500MG;EQ 85MG BASE N021926 001 Apr 15, 2008
NARATRIPTAN
TABLET;ORAL
NARATRIPTAN
AB APOTEX CORP EQ 1MG BASE A091373 001 Apr 22, 2011
AB EQ 2.5MG BASE A091373 002 Apr 22, 2011
AB SUN PHARM INDS LTD EQ 2.5MG BASE A091552 001 Feb 14, 2011
NARATRIPTAN HYDROCHLORIDE
TABLET;ORAL
AMERGE
AB GLAXOSMITHKLINE LLC EQ 1MG BASE N020763 002 Feb 10, 1998
AB + EQ 2.5MG BASE N020763 001 Feb 10, 1998
NARATRIPTAN
AB HERITAGE PHARMS INC EQ 1MG BASE A200502 001 Feb 28, 2011
AB EQ 2.5MG BASE A200502 002 Feb 28, 2011
AB MYLAN PHARMS INC EQ 1MG BASE A202431 001 May 31, 2012
AB EQ 2.5MG BASE A202431 002 May 31, 2012
AB ORCHID HLTHCARE EQ 1MG BASE A091441 001 Apr 30, 2012
AB EQ 2.5MG BASE A091441 002 Apr 30, 2012
AB PADDOCK LLC EQ 1MG BASE A091326 001 Jul 08, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
NARATRIPTAN HYDROCHLORIDE
TABLET;ORAL
NARATRIPTAN
AB
AB ROXANE
AB
AB SANDOZ
AB
AB TEVA PHARMS
AB
NATAMYCIN
SUSPENSION;OPHTHALMIC
NATACYN
+ ALCON
NATEGLINIDE
TABLET;ORAL
NATEGLINIDE
AB DR REDDYS LABS LTD
AB
AB PAR PHARM
AB
AB WATSON LABS
AB
STARLIX
AB NOVARTIS
AB +
NEBIVOLOL HYDROCHLORIDE
TABLET;ORAL
BYSTOLIC
FOREST LABS
+
NEDOCROMIL SODIUM
SOLUTION/DROPS;OPHTHALMIC
ALOCRIL
AT + ALLERGAN
NEDOCROMIL SODIUM
AT AKORN
NEFAZODONE HYDROCHLORIDE
TABLET;ORAL
NEFAZODONE HYDROCHLORIDE
AB RANBAXY
AB
AB
AB
AB
AB TEVA
AB
AB
AB
AB +
BX DR REDDYS LABS INC
BX
BX
BX
BX
NELARABINE
INJECTABLE;IV (INFUSION)
ARRANON
+ SMITHKLINE BEECHAM
NELFINAVIR MESYLATE
TABLET;ORAL
VIRACEPT
+ AGOURON
+
EQ 2.5MG BASE
EQ 1MG BASE
EQ 2.5MG BASE
EQ 1MG BASE
EQ 2.5MG BASE
EQ 1MG BASE
EQ 2.5MG BASE
5%
60MG
120MG
60MG
120MG
60MG
120MG
60MG
120MG
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE
2%
2%
50MG
100MG
150MG
200MG
250MG
50MG
100MG
150MG
200MG
250MG
50MG
100MG
150MG
200MG
250MG
250MG/50ML (5MG/ML)
EQ 250MG BASE
EQ 625MG BASE
3-257( of 362)
A091326 002 Jul 08, 2010
A090381 001 Jul 07, 2010
A090381 002 Jul 07, 2010
A090288 001 Jul 07, 2010
A090288 002 Jul 07, 2010
A078751 001 Jul 07, 2010
A078751 002 Jul 07, 2010
N050514 001
A077461 001 Sep 09, 2009
A077461 002 Sep 09, 2009
A077463 001 Sep 09, 2009
A077463 002 Sep 09, 2009
A077462 001 Mar 30, 2011
A077462 002 Mar 30, 2011
N021204 001 Dec 22, 2000
N021204 002 Dec 22, 2000
N021742 002 Dec 17, 2007
N021742 003 Dec 17, 2007
N021742 004 Dec 17, 2007
N021742 005 Oct 08, 2008
N021009 001 Dec 08, 1999
A090638 001 Aug 22, 2012
A076409 001 Sep 16, 2003
A076409 002 Sep 16, 2003
A076409 003 Sep 16, 2003
A076409 004 Sep 16, 2003
A076409 005 Sep 16, 2003
A076037 001 Sep 16, 2003
A076037 002 Sep 16, 2003
A076037 003 Sep 16, 2003
A076037 004 Sep 16, 2003
A076037 005 Sep 16, 2003
A076309 001 Sep 16, 2003
A076309 002 Sep 16, 2003
A076309 003 Sep 16, 2003
A076309 004 Sep 16, 2003
A076309 005 Sep 16, 2003
N021877 001 Oct 28, 2005
N020779 001 Mar 14, 1997
N021503 001 Apr 30, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-258( of 362)
NEOMYCIN SULFATE
SOLUTION;ORAL
NEO-FRADIN
+ X GEN PHARMS EQ 87.5MG BASE/5ML A065010 001 May 23, 2002
TABLET;ORAL
NEOMYCIN SULFATE
AA OMAN PHARM PRODUCTS 500MG A065468 001 Mar 29, 2010
AA + TEVA 500MG A060304 001
AA X GEN PHARMS 500MG A065220 001 Jul 28, 2006
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SOLUTION;IRRIGATION
NEOMYCIN AND POLYMYXIN B SULFATE
AT WATSON LABS EQ 40MG BASE/ML;200,000 UNITS/ML A062664 001 Apr 08, 1986
AT X GEN PHARMS EQ 40MG BASE/ML;200,000 UNITS/ML A065106 001 Jan 31, 2006
AT EQ 40MG BASE/ML;200,000 UNITS/ML A065108 001 Jan 31, 2006
NEOSPORIN G.U. IRRIGANT
AT + MONARCH PHARMS EQ 40MG BASE/ML;200,000 UNITS/ML A060707 001
NEOSTIGMINE METHYLSULFATE
SOLUTION;INTRAVENOUS
BLOXIVERZ
+ ECLAT PHARMS LLC 5MG/10ML (0.5MG/ML) N204078 001 May 31, 2013
+ 10MG/10ML (1MG/ML) N204078 002 May 31, 2013
NEPAFENAC
SUSPENSION/DROPS;OPHTHALMIC
ILEVRO
+ ALCON RES LTD 0.3% N203491 001 Oct 16, 2012
NEVANAC
+ ALCON PHARMS LTD 0.1% N021862 001 Aug 19, 2005
NESIRITIDE RECOMBINANT
FOR SOLUTION;INTRAVENOUS
NATRECOR
+ SCIOS LLC 1.5MG/VIAL N020920 001 Aug 10, 2001
NEVIRAPINE
SUSPENSION;ORAL
NEVIRAPINE
AA AUROBINDO 50MG/5ML A077702 001 May 22, 2012
VIRAMUNE
AA + BOEHRINGER INGELHEIM 50MG/5ML N020933 001 Sep 11, 1998
TABLET;ORAL
NEVIRAPINE
AB APOTEX INC 200MG A203021 001 May 22, 2012
AB AUROBINDO 200MG A077521 001 May 22, 2012
AB CIPLA 200MG A077956 001 May 22, 2012
AB HETERO LABS LTD III 200MG A078584 001 May 22, 2012
AB MICRO LABS LTD 200MG A203080 001 May 22, 2012
AB MYLAN LABS 200MG A078864 001 May 22, 2012
AB MYLAN PHARMS INC 200MG A202523 001 May 22, 2012
AB PRINSTON INC 200MG A078644 001 May 22, 2012
AB SCIEGEN PHARMS INC 200MG A203176 001 May 22, 2012
AB STRIDES 200MG A078195 001 May 22, 2012
VIRAMUNE
AB + BOEHRINGER INGELHEIM 200MG N020636 001 Jun 21, 1996
TABLET, EXTENDED RELEASE;ORAL
VIRAMUNE XR
BOEHRINGER INGELHEIM 100MG N201152 002 Nov 08, 2012
+ 400MG N201152 001 Mar 25, 2011
NIACIN
TABLET;ORAL
NIACIN
AA WOCKHARDT 500MG A081134 001 Apr 28, 1992
NIACOR
AA + UPSHER SMITH 500MG A040378 001 May 03, 2000
TABLET, EXTENDED RELEASE;ORAL
NIACIN
AB BARR 1GM A076250 001 Apr 14, 2005
AB 500MG A076378 001 Apr 26, 2005
AB 750MG A076378 002 Apr 26, 2005
NIASPAN
AB + ABBVIE 1GM N020381 004 Jul 28, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-259( of 362)
NIACIN
TABLET, EXTENDED RELEASE;ORAL
NIASPAN
AB 500MG N020381 002 Jul 28, 1997
AB + 750MG N020381 003 Jul 28, 1997
NIACIN; SIMVASTATIN
TABLET, EXTENDED RELEASE;ORAL
SIMCOR
+ ABBVIE 1GM;20MG N022078 003 Feb 15, 2008
+ 1GM;40MG N022078 005 Jul 28, 2010
+ 500MG;20MG N022078 001 Feb 15, 2008
+ 500MG;40MG N022078 004 Jul 28, 2010
+ 750MG;20MG N022078 002 Feb 15, 2008
NICARDIPINE HYDROCHLORIDE
CAPSULE;ORAL
CARDENE
AB EKR THERAP 20MG N019488 001 Dec 21, 1988
AB + 30MG N019488 002 Dec 21, 1988
NICARDIPINE HYDROCHLORIDE
AB BARR 20MG A074439 001 Dec 10, 1996
AB 30MG A074439 002 Dec 10, 1996
AB EPIC PHARMA 20MG A074928 001 Mar 19, 1998
AB 30MG A074928 002 Mar 19, 1998
AB MYLAN 20MG A074642 001 Jul 18, 1996
AB 30MG A074642 002 Jul 18, 1996
AB TEVA 20MG A074540 001 Oct 28, 1996
AB 30MG A074540 002 Oct 28, 1996
AB WATSON LABS 20MG A074670 001 Oct 28, 1996
AB 30MG A074670 002 Oct 28, 1996
CAPSULE, EXTENDED RELEASE;ORAL
CARDENE SR
+ EKR THERAP 30MG N020005 001 Feb 21, 1992
+ 60MG N020005 003 Feb 21, 1992
INJECTABLE;INJECTION
CARDENE
AP + EKR THERAP 25MG/10ML (2.5MG/ML) N019734 001 Jan 30, 1992
NICARDIPINE HYDROCHLORIDE
AP BEDFORD 25MG/10ML (2.5MG/ML) A078714 001 Dec 28, 2009
AP EXELA PHARMA SCIENCE 25MG/10ML (2.5MG/ML) N022276 001 Jul 24, 2008
AP MYLAN INSTITUTIONAL 25MG/10ML (2.5MG/ML) A090664 001 Nov 17, 2009
AP NAVINTA LLC 25MG/10ML (2.5MG/ML) A090125 001 Nov 17, 2009
AP PHARMAFORCE 25MG/10ML (2.5MG/ML) A090534 001 Nov 17, 2009
AP SUN PHARMA GLOBAL 25MG/10ML (2.5MG/ML) N078405 001 Nov 17, 2009
AP WOCKHARDT 25MG/10ML (2.5MG/ML) A090671 001 Nov 17, 2009
INJECTABLE;INTRAVENOUS
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
+ EKR THERAP 40MG/200ML (0.2MG/ML) N019734 004 Nov 07, 2008
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
+ EKR THERAP 20MG/200ML (0.1MG/ML) N019734 003 Jul 31, 2008
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
+ EKR THERAP 20MG/200ML (0.1MG/ML) N019734 002 Jul 31, 2008
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
+ EKR THERAP 40MG/200ML (0.2MG/ML) N019734 005 Nov 07, 2008
NICOTINE
INHALANT;ORAL
NICOTROL
+ PHARMACIA AND UPJOHN 4MG/CARTRIDGE N020714 001 May 02, 1997
SPRAY, METERED;NASAL
NICOTROL
+ PFIZER INC 0.5MG/SPRAY N020385 001 Mar 22, 1996
NIFEDIPINE
CAPSULE;ORAL
NIFEDIPINE
AB ACTAVIS ELIZABETH 10MG A072579 001 Jan 08, 1991
AB 20MG A072556 001 Sep 20, 1990
AB EMCURE PHARMS USA 10MG A202644 001 Apr 25, 2013
AB 20MG A202644 002 Apr 25, 2013
AB INTERGEL PHARM 10MG A072781 001 Jul 30, 1993
PROCARDIA
AB + PFIZER 10MG N018482 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-260( of 362)
NIFEDIPINE
TABLET, EXTENDED RELEASE;ORAL
ADALAT CC
AB1 BAYER HLTHCARE 30MG N020198 001 Apr 21, 1993
AB1 + 60MG N020198 002 Apr 21, 1993
AB1 + 90MG N020198 003 Apr 21, 1993
AFEDITAB CR
AB1 WATSON LABS 30MG A075128 001 Mar 10, 2000
AB1 60MG A075659 001 Oct 26, 2001
NIFEDIPINE
AB1 MYLAN 30MG A201071 001 Dec 03, 2010
AB1 60MG A201071 002 Dec 03, 2010
AB1 90MG A201071 003 Dec 03, 2010
AB1 PAR PHARM 30MG A077899 001 Dec 13, 2006
AB1 60MG A077899 002 Dec 13, 2006
AB1 90MG A077899 003 May 25, 2012
AB1 VALEANT INTL 30MG A075269 001 Dec 04, 2000
AB1 60MG A075269 002 Dec 04, 2000
AB1 90MG A076070 001 Aug 16, 2002
AB2 MATRIX LABS LTD 30MG A090602 001 Sep 13, 2010
AB2 60MG A090602 002 Sep 13, 2010
AB2 90MG A090602 003 Sep 13, 2010
AB2 MYLAN 30MG A090649 001 Jun 21, 2010
AB2 60MG A090649 002 Jun 21, 2010
AB2 90MG A090649 003 Jun 21, 2010
AB2 OSMOTICA PHARM 30MG A077127 001 Nov 21, 2005
AB2 60MG A077127 002 Nov 21, 2005
AB2 90MG A077410 001 Oct 03, 2007
AB2 VALEANT INTL 30MG A075289 002 Feb 06, 2001
AB2 60MG A075289 001 Sep 27, 2000
PROCARDIA XL
AB2 PFIZER 30MG N019684 001 Sep 06, 1989
AB2 60MG N019684 002 Sep 06, 1989
AB2 + 90MG N019684 003 Sep 06, 1989
NILOTINIB HYDROCHLORIDE MONOHYDRATE
CAPSULE;ORAL
TASIGNA
NOVARTIS EQ 150MG BASE N022068 002 Jun 17, 2010
+ EQ 200MG BASE N022068 001 Oct 29, 2007
NILUTAMIDE
TABLET;ORAL
NILANDRON
+ COVIS PHARMA SARL 150MG N020169 002 Apr 30, 1999
NIMODIPINE
CAPSULE;ORAL
NIMODIPINE
AB + BANNER PHARMACAPS 30MG A076740 001 Jan 17, 2008
AB BARR LABS INC 30MG A077811 001 May 02, 2007
AB SUN PHARM INDS INC 30MG A077067 001 Apr 17, 2007
SOLUTION;ORAL
NYMALIZE
+ ARBOR PHARMS INC 60MG/20ML N203340 001 May 10, 2013
NISOLDIPINE
TABLET, EXTENDED RELEASE;ORAL
NISOLDIPINE
AB MYLAN 8.5MG A091001 001 Jan 26, 2011
AB 17MG A091001 002 Jan 26, 2011
AB 34MG A091001 004 Jan 26, 2011
SULAR
AB + SHIONOGI INC 8.5MG N020356 008 Jan 02, 2008
AB + 17MG N020356 007 Jan 02, 2008
AB + 34MG N020356 005 Jan 02, 2008
NISOLDIPINE
MYLAN 20MG A079051 001 Jul 25, 2008
25.5MG A091001 003 Jan 26, 2011
+ 30MG A079051 002 Jul 25, 2008
+ 40MG A079051 003 Jul 25, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-261( of 362)
NITAZOXANIDE
FOR SUSPENSION;ORAL
ALINIA
+ ROMARK 100MG/5ML N021498 001 Nov 22, 2002
TABLET;ORAL
ALINIA
+ ROMARK 500MG N021497 001 Jul 21, 2004
NITISINONE
CAPSULE;ORAL
ORFADIN
SWEDISH ORPHAN 2MG N021232 001 Jan 18, 2002
5MG N021232 002 Jan 18, 2002
+ 10MG N021232 003 Jan 18, 2002
NITRIC OXIDE
GAS;INHALATION
INOMAX
INO 100PPM N020845 002 Dec 23, 1999
+ 800PPM N020845 003 Dec 23, 1999
NITROFURANTOIN
SUSPENSION;ORAL
FURADANTIN
AB + SHIONOGI INC 25MG/5ML N009175 001
NITROFURANTOIN
AB AMNEAL PHARMS 25MG/5ML A201679 001 May 11, 2011
AB CARACO 25MG/5ML A201355 001 Aug 14, 2013
NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE;ORAL
MACRODANTIN
AB ALVOGEN INC 50MG N016620 001
AB + 100MG N016620 002
NITROFURANTOIN
AB IVAX SUB TEVA PHARMS 50MG A073671 001 Jan 28, 1993
AB 100MG A073652 001 Jan 28, 1993
AB MYLAN 50MG A074967 001 Jul 09, 1997
AB 100MG A077025 001 Aug 18, 2004
MACRODANTIN
ALVOGEN INC 25MG N016620 003
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE;ORAL
MACROBID
AB + ALVOGEN INC 75MG;25MG N020064 001 Dec 24, 1991
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
AB MYLAN 75MG;25MG A076648 001 Mar 22, 2004
AB SANDOZ 75MG;25MG A077066 001 Apr 05, 2005
NITROGLYCERIN
AEROSOL, METERED;SUBLINGUAL
NITROMIST
+ MIST PHARMS LLC 0.4MG/SPRAY N021780 001 Nov 02, 2006
FILM, EXTENDED RELEASE;TRANSDERMAL
MINITRAN
AB1 MEDICIS 0.1MG/HR A089771 001 Aug 30, 1996
AB1 0.2MG/HR A089772 001 Aug 30, 1996
AB1 0.4MG/HR A089773 001 Aug 30, 1996
AB1 0.6MG/HR A089774 001 Aug 30, 1996
NITRO-DUR
AB1 + MERCK SHARP DOHME 0.1MG/HR N020145 001 Apr 04, 1995
AB1 + 0.2MG/HR N020145 002 Apr 04, 1995
AB1 + 0.4MG/HR N020145 004 Apr 04, 1995
AB1 + 0.6MG/HR N020145 005 Apr 04, 1995
NITROGLYCERIN
AB1 KREMERS URBAN PHARMS 0.2MG/HR A075115 001 Aug 10, 2004
AB1 0.4MG/HR A075115 002 Aug 10, 2004
AB2 HERCON PHARM 0.2MG/HR A089884 001 Oct 30, 1998
AB2 0.4MG/HR A089885 001 Oct 30, 1998
AB2 0.6MG/HR A089886 001 Oct 30, 1998
AB2 + MYLAN TECHNOLOGIES 0.2MG/HR A074559 003 Aug 30, 1996
AB2 + 0.4MG/HR A074559 002 Aug 30, 1996
AB2 + 0.6MG/HR A074559 001 Aug 30, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-262( of 362)
NITROGLYCERIN
FILM, EXTENDED RELEASE;TRANSDERMAL
NITRO-DUR
+ MERCK SHARP DOHME 0.3MG/HR N020145 003 Apr 04, 1995
+ 0.8MG/HR N020145 006 Apr 04, 1995
NITROGLYCERIN
+ MYLAN TECHNOLOGIES 0.1MG/HR A074559 004 Feb 06, 1998
INJECTABLE;INJECTION
NITROGLYCERIN IN DEXTROSE 5%
AP + BAXTER HLTHCARE 10MG/100ML N019970 001 Dec 29, 1989
AP + 20MG/100ML N019970 002 Dec 29, 1989
AP + 40MG/100ML N019970 003 Dec 29, 1989
AP HOSPIRA 10MG/100ML A071846 001 Aug 31, 1990
AP 20MG/100ML A071847 001 Aug 31, 1990
AP 40MG/100ML A071848 001 Aug 31, 1990
NITROGLYCERIN
+ LUITPOLD 5MG/ML A072034 001 May 24, 1988
OINTMENT;INTRA-ANAL
RECTIV
+ APTALIS PHARMA 0.4% N021359 001 Jun 21, 2011
OINTMENT;TRANSDERMAL
NITROGLYCERIN
+ FOUGERA 2% A087355 001 Jul 08, 1988
SPRAY, METERED;SUBLINGUAL
NITROGLYCERIN
AB PERRIGO ISRAEL 0.4MG/SPRAY A091496 001 Sep 20, 2013
NITROLINGUAL PUMPSPRAY
AB + POHL BOSKAMP 0.4MG/SPRAY N018705 002 Jan 10, 1997
TABLET;SUBLINGUAL
NITROSTAT
PFIZER PHARMS 0.3MG N021134 001 May 01, 2000
0.4MG N021134 002 May 01, 2000
+ 0.6MG N021134 003 May 01, 2000
NIZATIDINE
CAPSULE;ORAL
NIZATIDINE
AB DR REDDYS LABS LTD 150MG A077314 001 Sep 15, 2005
AB 300MG A077314 002 Sep 15, 2005
AB GLENMARK GENERICS 150MG A090618 001 Jul 15, 2011
AB 300MG A090618 002 Jul 15, 2011
AB MYLAN PHARMS INC 150MG A075806 001 Jul 05, 2002
AB + 300MG A075806 002 Jul 05, 2002
AB SANDOZ 150MG A076178 001 Jul 05, 2002
AB 300MG A076178 002 Jul 05, 2002
AB TEVA 150MG A075668 001 Sep 12, 2002
AB 300MG A075668 002 Sep 12, 2002
AB WATSON LABS 150MG A075616 001 Jul 09, 2002
AB 300MG A075616 002 Jul 09, 2002
SOLUTION;ORAL
AXID
AA + BRAINTREE 15MG/ML N021494 001 May 25, 2004
NIZATIDINE
AA AMNEAL PHARMS 15MG/ML A090576 001 Nov 18, 2009
NOREPINEPHRINE BITARTRATE
INJECTABLE;INJECTION
LEVOPHED
AP + HOSPIRA EQ 1MG BASE/ML N007513 001
NOREPINEPHRINE BITARTRATE
AP BEDFORD EQ 1MG BASE/ML A040462 001 Oct 31, 2003
AP CLARIS LIFESCIENCES EQ 1MG BASE/ML A040859 001 Mar 27, 2012
AP TEVA PHARMS USA EQ 1MG BASE/ML A040455 001 Mar 03, 2003
NORETHINDRONE
TABLET;ORAL-28
CAMILA
AB1 BARR 0.35MG A076177 001 Oct 21, 2002
HEATHER
AB1 GLENMARK GENERICS 0.35MG A090454 001 Apr 23, 2010
NOR-QD
AB1 + WATSON LABS (UTAH) 0.35MG N017060 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-263( of 362)
NORETHINDRONE
TABLET;ORAL-28
NORETHINDRONE
AB1 FAMY CARE LTD 0.35MG A201483 001 Jun 24, 2013
AB1 HAUPT PHARMA 0.35MG A202260 001 Aug 01, 2013
AB1 LUPIN LTD 0.35MG A091325 001 Sep 19, 2011
AB1 NOVAST LABS LTD 0.35MG A202014 001 Sep 13, 2013
ERRIN
AB2 BARR 0.35MG A076225 001 Oct 21, 2002
JENCYCLA
AB2 LUPIN LTD 0.35MG A091323 001 Mar 28, 2013
MICRONOR
AB2 + JANSSEN PHARMS 0.35MG N016954 001
NORETHIDRONE
AB2 GLENMARK GENERICS 0.35MG A091209 001 Jul 21, 2010
NORETHINDRONE
AB2 FAMY CARE LTD 0.35MG A200980 001 Jun 12, 2013
AB2 NOVAST LABS 0.35MG A200961 001 Sep 13, 2013
NORETHINDRONE ACETATE
TABLET;ORAL
AYGESTIN
AB + DURAMED RES 5MG N018405 001 Apr 21, 1982
NORETHINDRONE ACETATE
AB AMNEAL PHARMS 5MG A200275 001 Jul 30, 2012
AB BARR 5MG A075951 001 May 25, 2001
AB GLENMARK GENERICS 5MG A091090 001 Jul 21, 2010
NORFLOXACIN
TABLET;ORAL
NOROXIN
+ MERCK 400MG N019384 002 Oct 31, 1986
NORTRIPTYLINE HYDROCHLORIDE
CAPSULE;ORAL
NORTRIPTYLINE HYDROCHLORIDE
AB MYLAN EQ 10MG BASE A074234 001 Jul 26, 1993
AB EQ 25MG BASE A074234 002 Jul 26, 1993
AB EQ 50MG BASE A074234 003 Jul 26, 1993
AB EQ 75MG BASE A074234 004 Jul 26, 1993
AB TARO EQ 10MG BASE A075520 004 May 08, 2000
AB EQ 25MG BASE A075520 003 May 08, 2000
AB EQ 50MG BASE A075520 001 May 08, 2000
AB EQ 75MG BASE A075520 002 May 08, 2000
AB TEVA EQ 10MG BASE A074132 001 Mar 27, 1995
AB EQ 25MG BASE A074132 002 Mar 27, 1995
AB EQ 50MG BASE A074132 003 Mar 27, 1995
AB EQ 75MG BASE A074132 004 Mar 27, 1995
AB WATSON LABS EQ 10MG BASE A073553 001 Mar 30, 1992
AB EQ 25MG BASE A073554 001 Mar 30, 1992
AB EQ 50MG BASE A073555 001 Mar 30, 1992
AB EQ 75MG BASE A073556 001 Mar 30, 1992
PAMELOR
AB MALLINCKRODT LLC EQ 10MG BASE N018013 001
AB EQ 25MG BASE N018013 002
AB EQ 50MG BASE N018013 004
AB + EQ 75MG BASE N018013 003
SOLUTION;ORAL
AVENTYL HYDROCHLORIDE
AA + RANBAXY EQ 10MG BASE/5ML N014685 001
NORTRIPTYLINE HYDROCHLORIDE
AA PHARM ASSOC EQ 10MG BASE/5ML A075606 001 Aug 28, 2000
AA TARO EQ 10MG BASE/5ML A077965 001 Jun 20, 2006
NYSTATIN
CREAM;TOPICAL
NYSTATIN
AT ACTAVIS MID ATLANTIC 100,000 UNITS/GM A062949 001 Jun 13, 1988
AT FOUGERA PHARMS 100,000 UNITS/GM A062129 001
AT PERRIGO NEW YORK 100,000 UNITS/GM A062225 001
AT + TARO 100,000 UNITS/GM A064022 001 Jan 29, 1993
AT VINTAGE 100,000 UNITS/GM A065315 001 May 31, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-264( of 362)
NYSTATIN
OINTMENT;TOPICAL
NYSTATIN
AT ACTAVIS MID ATLANTIC 100,000 UNITS/GM A062840 001 Nov 13, 1987
AT + FOUGERA PHARMS 100,000 UNITS/GM A062124 002 Sep 23, 1982
AT PERRIGO NEW YORK 100,000 UNITS/GM A062472 001 Feb 13, 1984
POWDER;TOPICAL
NYSTATIN
AT + COASTAL PHARMS 100,000 UNITS/GM A065203 001 Jul 15, 2004
AT GAVIS PHARMS 100,000 UNITS/GM A065138 001 Jul 23, 2004
AT UPSHER SMITH 100,000 UNITS/GM A065183 001 May 03, 2005
AT X GEN PHARMS 100,000 UNITS/GM A065175 001 Dec 17, 2004
NYSTOP
AT PADDOCK LLC 100,000 UNITS/GM A064118 001 Aug 16, 1996
SUSPENSION;ORAL
NYSTATIN
AA ACTAVIS MID ATLANTIC 100,000 UNITS/ML A062349 001 Jul 14, 1982
AA FOUGERA 100,000 UNITS/ML A062517 001 Jun 07, 1984
AA HI TECH PHARMA 100,000 UNITS/ML A064042 001 Feb 28, 1994
AA TARO 100,000 UNITS/ML A062876 001 Feb 29, 1988
AA VINTAGE PHARMS 100,000 UNITS/ML A065148 001 Jun 28, 2005
AA VISTAPHARM 100,000 UNITS/ML A064142 001 Jun 25, 1998
AA 100,000 UNITS/ML A065422 001 Mar 07, 2011
AA + WOCKHARDT 100,000 UNITS/ML A062512 001 Oct 29, 1984
TABLET;ORAL
NYSTATIN
AA HERITAGE PHARMS INC 500,000 UNITS A062474 001 Dec 22, 1983
AA MUTUAL PHARM 500,000 UNITS A062838 001 Dec 22, 1988
AA + TEVA 500,000 UNITS A062506 001 Jan 16, 1984
TABLET;VAGINAL
NYSTATIN
+ ODYSSEY PHARMS 100,000 UNITS A062615 001 Oct 17, 1985
NYSTATIN; TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
NYSTATIN AND TRIAMCINOLONE ACETONIDE
AT FOUGERA 100,000 UNITS/GM;0.1% A062599 001 Oct 08, 1985
AT + TARO 100,000 UNITS/GM;0.1% A062364 001 Dec 22, 1987
OINTMENT;TOPICAL
NYSTATIN AND TRIAMCINOLONE ACETONIDE
AT FOUGERA 100,000 UNITS/GM;0.1% A062602 001 Oct 09, 1985
AT + TARO 100,000 UNITS/GM;0.1% A063305 001 Mar 29, 1993
OCTREOTIDE ACETATE
INJECTABLE;INJECTION
OCTREOTIDE ACETATE
AP + BEDFORD EQ 0.2MG BASE/ML A076330 001 Apr 08, 2005
AP + EQ 1MG BASE/ML A076330 002 Apr 08, 2005
AP FRESENIUS KABI USA EQ 0.2MG BASE/ML A077450 001 Feb 10, 2006
AP EQ 1MG BASE/ML A077450 002 Feb 10, 2006
AP SAGENT PHARMS EQ 0.2MG BASE/ML A091041 001 Nov 12, 2013
AP EQ 1MG BASE/ML A091041 002 Nov 12, 2013
AP SUN PHARM INDS EQ 0.05MG BASE/ML A077329 001 Mar 04, 2008
AP EQ 0.05MG BASE/ML A077372 001 Aug 14, 2007
AP EQ 0.1MG BASE/ML A077329 002 Mar 04, 2008
AP EQ 0.1MG BASE/ML A077372 002 Aug 14, 2007
AP EQ 0.2MG BASE/ML A077330 001 Mar 04, 2008
AP EQ 0.2MG BASE/ML A077373 001 Aug 14, 2007
AP EQ 0.5MG BASE/ML A077329 003 Mar 04, 2008
AP EQ 0.5MG BASE/ML A077372 003 Aug 14, 2007
AP EQ 1MG BASE/ML A077331 001 Mar 04, 2008
AP EQ 1MG BASE/ML A077373 002 Aug 14, 2007
AP TEVA PHARMS USA EQ 0.05MG BASE/ML A075957 001 Oct 03, 2005
AP EQ 0.1MG BASE/ML A075957 002 Oct 03, 2005
AP EQ 0.2MG BASE/ML A075959 001 Nov 21, 2005
AP EQ 0.5MG BASE/ML A075957 003 Oct 03, 2005
AP EQ 1MG BASE/ML A075959 002 Nov 21, 2005
AP WOCKHARDT USA EQ 0.2MG BASE/ML A090986 001 May 11, 2011
AP EQ 1MG BASE/ML A090986 002 May 11, 2011
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
AP + BEDFORD EQ 0.05MG BASE/ML A076313 001 Mar 28, 2005
AP + EQ 0.1MG BASE/ML A076313 003 Mar 28, 2005
AP + EQ 0.5MG BASE/ML A076313 002 Mar 28, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-265( of 362)
OCTREOTIDE ACETATE
INJECTABLE;INJECTION
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
AP FRESENIUS KABI USA EQ 0.05MG BASE/ML A077457 001 Feb 10, 2006
AP EQ 0.1MG BASE/ML A077457 002 Feb 10, 2006
AP EQ 0.5MG BASE/ML A077457 003 Feb 10, 2006
AP MYLAN INSTITUTIONAL EQ 0.05MG BASE/ML A079198 001 Feb 10, 2011
AP EQ 0.1MG BASE/ML A079198 002 Feb 10, 2011
AP EQ 0.5MG BASE/ML A079198 003 Feb 10, 2011
AP SAGENT PHARMS EQ 0.05MG BASE/ML A090834 001 Nov 12, 2013
AP EQ 0.1MG BASE/ML A090834 002 Nov 12, 2013
AP EQ 0.5MG BASE/ML A090834 003 Nov 12, 2013
AP WOCKHARDT USA EQ 0.05MG BASE/ML A090985 001 May 11, 2011
AP EQ 0.1MG BASE/ML A090985 002 May 11, 2011
AP EQ 0.5MG BASE/ML A090985 003 May 11, 2011
SANDOSTATIN
AP + NOVARTIS EQ 0.05MG BASE/ML N019667 001 Oct 21, 1988
AP + EQ 0.1MG BASE/ML N019667 002 Oct 21, 1988
AP + EQ 0.2MG BASE/ML N019667 004 Jun 12, 1991
AP + EQ 0.5MG BASE/ML N019667 003 Oct 21, 1988
AP + EQ 1MG BASE/ML N019667 005 Jun 12, 1991
SANDOSTATIN LAR
NOVARTIS EQ 10MG BASE/VIAL N021008 001 Nov 25, 1998
EQ 20MG BASE/VIAL N021008 002 Nov 25, 1998
+ EQ 30MG BASE/VIAL N021008 003 Nov 25, 1998
OFLOXACIN
SOLUTION/DROPS;OPHTHALMIC
OCUFLOX
AT + ALLERGAN 0.3% N019921 001 Jul 30, 1993
OFLOXACIN
AT AKORN 0.3% A076407 001 Apr 15, 2008
AT ALCON PHARMS LTD 0.3% A076231 001 May 14, 2004
AT ALTAIRE PHARMS INC 0.3% A202692 001 Apr 29, 2013
AT BAUSCH AND LOMB 0.3% A076622 001 May 14, 2004
AT FDC LTD 0.3% A078559 001 Feb 25, 2009
AT FERA PHARMS 0.3% A076830 001 Aug 31, 2004
AT HI TECH PHARMA 0.3% A076615 001 May 14, 2004
SOLUTION/DROPS;OTIC
FLOXIN OTIC
AT + DAIICHI 0.3% N020799 001 Dec 16, 1997
OFLOXACIN
AT ALCON PHARMS LTD 0.3% A078222 001 Mar 17, 2008
AT APOTEX INC 0.3% A076527 001 Sep 28, 2007
AT BAUSCH AND LOMB 0.3% A076128 001 Mar 17, 2008
AT FERA PHARMS 0.3% A090395 001 Aug 11, 2009
AT HI TECH PHARMA 0.3% A076616 001 Mar 17, 2008
TABLET;ORAL
OFLOXACIN
AB DR REDDYS LABS LTD 200MG A077098 001 Feb 10, 2006
AB 300MG A077098 002 Feb 10, 2006
AB 400MG A077098 003 Feb 10, 2006
AB TEVA 200MG A076182 001 Sep 02, 2003
AB 300MG A076182 002 Sep 02, 2003
AB + 400MG A076182 003 Sep 02, 2003
OLANZAPINE
INJECTABLE;INTRAMUSCULAR
OLANZAPINE
AP LUITPOLD 10MG/VIAL A201741 001 Mar 20, 2012
AP SANDOZ INC 10MG/VIAL A201588 001 Oct 24, 2011
ZYPREXA
AP + LILLY 10MG/VIAL N021253 001 Mar 29, 2004
TABLET;ORAL
OLANZAPINE
AB APOTEX INC 2.5MG A090798 001 Apr 23, 2012
AB 5MG A090798 002 Apr 23, 2012
AB 7.5MG A090798 003 Apr 23, 2012
AB 10MG A090798 004 Apr 23, 2012
AB 15MG A090798 005 Apr 23, 2012
AB 20MG A090798 006 Apr 23, 2012
AB AUROBINDO PHARMA LTD 2.5MG A202050 001 Apr 23, 2012
AB 5MG A202050 002 Apr 23, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-266( of 362)
OLANZAPINE
TABLET;ORAL
OLANZAPINE
AB 7.5MG A202050 003 Apr 23, 2012
AB 10MG A202050 004 Apr 23, 2012
AB 15MG A202050 005 Apr 23, 2012
AB 20MG A202050 006 Apr 23, 2012
AB DR REDDYS LABS LTD 2.5MG A076255 001 Apr 23, 2012
AB 5MG A076255 002 Apr 23, 2012
AB 7.5MG A076255 003 Apr 23, 2012
AB 10MG A076255 004 Apr 23, 2012
AB 15MG A076133 001 Apr 23, 2012
AB 20MG A076133 002 Oct 24, 2011
AB MYLAN 2.5MG A076866 001 Apr 23, 2012
AB 5MG A076866 002 Apr 23, 2012
AB 7.5MG A076866 003 Apr 23, 2012
AB 10MG A076866 004 Apr 23, 2012
AB 15MG A076866 005 Apr 23, 2012
AB 20MG A076866 006 Apr 23, 2012
AB ORCHID HLTHCARE 2.5MG A202287 001 Apr 23, 2012
AB 5MG A202287 002 Apr 23, 2012
AB 7.5MG A202287 003 Apr 23, 2012
AB 10MG A202287 004 Apr 23, 2012
AB 15MG A202287 005 Apr 23, 2012
AB 20MG A202287 006 Apr 23, 2012
AB SUN PHARM INDS 2.5MG A091038 001 Apr 23, 2012
AB 5MG A091038 002 Apr 23, 2012
AB 7.5MG A091038 003 Apr 23, 2012
AB 10MG A091038 004 Apr 23, 2012
AB 15MG A091038 005 Apr 23, 2012
AB 20MG A091038 006 Apr 23, 2012
AB TEVA PHARMS 2.5MG A076000 001 Oct 24, 2011
AB 5MG A076000 002 Oct 24, 2011
AB 7.5MG A076000 003 Oct 24, 2011
AB 10MG A076000 004 Oct 24, 2011
AB 15MG A076000 005 Oct 24, 2011
AB TORRENT PHARMS LTD 2.5MG A091434 001 Apr 23, 2012
AB 5MG A091434 002 Apr 23, 2012
AB 7.5MG A091434 003 Apr 23, 2012
AB 10MG A091434 004 Apr 23, 2012
AB 15MG A091434 005 Apr 23, 2012
AB 20MG A091434 006 Apr 23, 2012
ZYPREXA
AB LILLY 2.5MG N020592 001 Sep 30, 1996
AB + 5MG N020592 002 Sep 30, 1996
AB 7.5MG N020592 003 Sep 30, 1996
AB 10MG N020592 004 Sep 30, 1996
AB 15MG N020592 005 Sep 09, 1997
AB 20MG N020592 006 Sep 09, 1997
TABLET, ORALLY DISINTEGRATING;ORAL
OLANZAPINE
AB APOTEX INC 5MG A091265 001 Oct 24, 2011
AB 10MG A091265 002 Oct 24, 2011
AB 15MG A091265 003 Oct 24, 2011
AB 20MG A091265 004 Oct 24, 2011
AB BARR LABS INC 5MG A077243 001 Jan 30, 2012
AB 10MG A077243 002 Jan 30, 2012
AB 15MG A077243 003 Jan 30, 2012
AB 20MG A077243 004 Jan 30, 2012
AB DR REDDYS LABS LTD 5MG A076534 001 Oct 24, 2011
AB 10MG A076534 002 Oct 24, 2011
AB 15MG A076534 003 Oct 24, 2011
AB 20MG A076534 004 Oct 24, 2011
AB JUBILANT ORGANOSYS 5MG A200221 001 Sep 12, 2012
AB 10MG A200221 002 Sep 12, 2012
AB 15MG A200221 003 Sep 12, 2012
AB 20MG A200221 004 Sep 12, 2012
AB PAR PHARM 5MG A078109 001 Oct 24, 2011
AB 10MG A078109 002 Oct 24, 2011
AB 15MG A078109 003 Oct 24, 2011
AB 20MG A078109 004 Oct 24, 2011
AB SUN PHARM INDS 5MG A090881 001 Feb 28, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-267( of 362)
OLANZAPINE
TABLET, ORALLY DISINTEGRATING;ORAL
OLANZAPINE
AB 10MG A090881 002 Feb 28, 2012
AB 15MG A090881 003 Feb 28, 2012
AB 20MG A090881 004 Feb 28, 2012
AB TORRENT PHARMS LLC 5MG A091415 001 Oct 25, 2011
AB 10MG A091415 002 Oct 25, 2011
AB 15MG A091415 003 Oct 25, 2011
AB 20MG A091415 004 Oct 25, 2011
ZYPREXA ZYDIS
AB + LILLY 5MG N021086 001 Apr 06, 2000
AB 10MG N021086 002 Apr 06, 2000
AB 15MG N021086 003 Apr 06, 2000
AB 20MG N021086 004 Apr 06, 2000
OLANZAPINE PAMOATE
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
ZYPREXA RELPREVV
ELI LILLY CO EQ 210MG BASE/VIAL N022173 001 Dec 11, 2009
EQ 300MG BASE/VIAL N022173 002 Dec 11, 2009
+ EQ 405MG BASE/VIAL N022173 003 Dec 11, 2009
OLIVE OIL; SOYBEAN OIL
INJECTABLE;INJECTION
CLINOLIPID 20%
+ BAXTER HLTHCARE 16%(160GM/1000ML);4% (40GM/1000ML) N204508 001 Oct 03, 2013
OLMESARTAN MEDOXOMIL
TABLET;ORAL
BENICAR
DAIICHI SANKYO 5MG N021286 001 Apr 25, 2002
20MG N021286 003 Apr 25, 2002
+ 40MG N021286 004 Apr 25, 2002
OLOPATADINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
PATADAY
+ ALCON PHARMS LTD EQ 0.2% BASE N021545 001 Dec 22, 2004
PATANOL
+ ALCON EQ 0.1% BASE N020688 001 Dec 18, 1996
SPRAY, METERED;NASAL
PATANASE
+ ALCON PHARMS LTD 0.665MG/SPRAY N021861 001 Apr 15, 2008
OLSALAZINE SODIUM
CAPSULE;ORAL
DIPENTUM
+ MEDA PHARMS 250MG N019715 001 Jul 31, 1990
OMACETAXINE MEPESUCCINATE
POWDER;SUBCUTANEOUS
SYNRIBO
+ IVAX INTL 3.5MG/VIAL N203585 001 Oct 26, 2012
OMEGA-3-ACID ETHYL ESTERS
CAPSULE;ORAL
LOVAZA
+ SMITHKLINE BEECHAM 1GM CONTAINS AT LEAST 900MG OF THE N021654 001 Nov 10, 2004
ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS;ORAL
OMEPRAZOLE
AB APOTEX 10MG A076048 001 Oct 22, 2007
AB 20MG A076048 002 Oct 22, 2007
AB 40MG A076048 003 Jan 21, 2009
AB DR REDDYS LABS LTD 10MG A075576 003 Oct 22, 2007
AB 10MG A078490 002 Mar 16, 2009
AB 20MG A075576 002 Oct 22, 2007
AB 20MG A078490 003 Mar 16, 2009
AB 40MG A075576 001 Jan 21, 2009
AB 40MG A078490 001 Apr 17, 2009
AB IMPAX LABS 10MG A075785 001 Oct 22, 2007
AB 20MG A075785 002 Oct 22, 2007
AB 40MG A075785 003 Jan 21, 2009
AB KREMERS URBAN PHARMS 10MG A075410 001 Nov 01, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-268( of 362)
OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS;ORAL
OMEPRAZOLE
AB 20MG A075410 002 Nov 01, 2002
AB 40MG A075410 003 Jan 23, 2009
AB MYLAN 10MG A075876 001 May 29, 2003
AB 20MG A075876 002 May 29, 2003
AB 40MG A075876 003 Jan 21, 2009
AB SANDOZ 10MG A075757 001 Jan 28, 2003
AB 20MG A075757 002 Jan 28, 2003
AB 40MG A076515 001 Jan 21, 2009
AB WATSON LABS FLORIDA 10MG A075347 001 May 30, 2008
AB 20MG A075347 002 May 30, 2008
AB 40MG A075347 003 May 30, 2008
AB ZYDUS PHARMS USA INC 10MG A091352 001 Nov 19, 2012
AB 20MG A091352 002 Nov 19, 2012
AB 40MG A091352 003 Nov 19, 2012
PRILOSEC
AB ASTRAZENECA 10MG N019810 003 Oct 05, 1995
AB + 20MG N019810 001 Sep 14, 1989
AB + 40MG N019810 002 Jan 15, 1998
OMEPRAZOLE MAGNESIUM
FOR SUSPENSION, DELAYED RELEASE;ORAL
PRILOSEC
ASTRAZENECA EQ 2.5MG BASE/PACKET N022056 001 Mar 20, 2008
+ EQ 10MG BASE/PACKET N022056 002 Mar 20, 2008
OMEPRAZOLE; SODIUM BICARBONATE
CAPSULE;ORAL
OMEPRAZOLE AND SODIUM BICARBONATE
AB PAR PHARM 20MG;1.1GM A078966 001 May 25, 2010
AB 40MG;1.1GM A078966 002 May 25, 2010
ZEGERID
AB SALIX PHARMS INC 20MG;1.1GM N021849 001 Feb 27, 2006
AB + 40MG;1.1GM N021849 002 Feb 27, 2006
FOR SUSPENSION;ORAL
OMEPRAZOLE AND SODIUM BICARBONATE
AB PAR PHARM 20MG/PACKET;1.68GM/PACKET A079182 001 Apr 19, 2013
AB 40MG/PACKET;1.68GM/PACKET A079182 002 Apr 19, 2013
ZEGERID
AB SALIX PHARMS INC 20MG/PACKET;1.68GM/PACKET N021636 001 Jun 15, 2004
AB + 40MG/PACKET;1.68GM/PACKET N021636 002 Dec 21, 2004
ONDANSETRON
FILM;ORAL
ZUPLENZ
VESTIQ PHARMS 4MG N022524 001 Jul 02, 2010
+ 8MG N022524 002 Jul 02, 2010
TABLET, ORALLY DISINTEGRATING;ORAL
ONDANSETRON
AB AUROBINDO PHARMA 4MG A090469 001 Apr 12, 2010
AB 8MG A090469 002 Apr 12, 2010
AB BARR 4MG A076693 001 Jun 25, 2007
AB 8MG A076693 002 Jun 25, 2007
AB GLENMARK GENERICS 4MG A078152 001 Jun 27, 2007
AB 8MG A078152 002 Jun 27, 2007
AB MYLAN 4MG A078139 001 Jun 25, 2007
AB 8MG A078139 002 Jun 25, 2007
AB RANBAXY 4MG A078602 001 Feb 24, 2011
AB 8MG A078602 002 Feb 24, 2011
AB SANDOZ 4MG A078050 001 Aug 13, 2007
AB 8MG A078050 002 Aug 13, 2007
AB SUN PHARM INDS 4MG A077557 001 Aug 02, 2007
AB 8MG A077557 002 Aug 02, 2007
AB TEVA 4MG A076810 001 Jun 25, 2007
AB 8MG A076810 002 Jun 25, 2007
ZOFRAN ODT
AB GLAXOSMITHKLINE 4MG N020781 001 Jan 27, 1999
AB + 8MG N020781 002 Jan 27, 1999
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
ONDANSETRON HYDROCHLORIDE
INJECTABLE;INJECTION
ONDANSETRON HYDROCHLORIDE
AP AGILA SPECLTS
AP AUROBINDO PHARMA LTD
AP BEDFORD
AP CLARIS LIFESCIENCES
AP EMCURE PHARMS
AP FRESENIUS KABI USA
AP GLAND PHARMA LTD
AP
AP HIKMA FARMACEUTICA
AP HIKMA MAPLE
AP HOSPIRA
AP
AP LANNETT
AP
AP LUITPOLD
AP SANDOZ
AP
AP
SUN PHARM INDS (IN)
TEVA
AP WOCKHARDT
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
AP AGILA SPECLTS
AP AUROBINDO PHARMA LTD
AP BD RX
AP BEDFORD LABS
AP CLARIS LIFESCIENCES
AP EMCURE PHARMS LTD
AP FRESENIUS KABI USA
AP HIKMA FARMACEUTICA
AP HIKMA MAPLE
AP HOSPIRA
AP LUITPOLD
AP SANDOZ
AP SUN PHARM INDS LTD
AP TARO PHARMS IRELAND
AP TEVA
AP WOCKHARDT
ZOFRAN
AP + GLAXOSMITHKLINE
ZOFRAN PRESERVATIVE FREE
AP + GLAXOSMITHKLINE
SOLUTION;ORAL
ONDANSETRON HYDROCHLORIDE
AA AMNEAL PHARMS
AA APOTEX
AA AUROBINDO PHARMA
AA ROXANE
AA SILARX
AA TARO
ZOFRAN
AA + GLAXOSMITHKLINE
TABLET;ORAL
ONDANSETRON HYDROCHLORIDE
AB APOTEX
AB
AB AUROBINDO PHARMA
AB
AB
AB DR REDDYS LABS LTD
AB
AB
AB GLENMARK GENERICS
AB
AB
AB MYLAN
AB
AB
AB NATCO PHARMA LTD
AB
AB PLIVA HRVATSKA DOO
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 4MG BASE/5ML
EQ 4MG BASE/5ML
EQ 4MG BASE/5ML
EQ 4MG BASE/5ML
EQ 4MG BASE/5ML
EQ 4MG BASE/5ML
EQ 4MG BASE/5ML
EQ 4MG BASE
EQ 8MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 4MG BASE
3-269( of 362)
A078257 001 Apr 23, 2008
A202599 001 Dec 21, 2012
A076967 001 Dec 26, 2006
A078288 001 Feb 22, 2013
A090424 001 Apr 16, 2010
A076974 001 Dec 26, 2006
A079224 001 Sep 25, 2009
A090648 001 Jun 15, 2012
A076781 001 Dec 26, 2006
A077365 001 Dec 26, 2006
A077473 001 Dec 26, 2006
A077840 001 Jan 19, 2007
A090116 001 Apr 14, 2010
A090883 001 Aug 05, 2010
A079039 001 Nov 18, 2008
A077430 001 Jun 27, 2007
A077172 001 Dec 26, 2006
A076876 001 Nov 22, 2006
A077577 001 Dec 26, 2006
A078244 001 Apr 23, 2008
A202600 001 Dec 21, 2012
A202253 001 Jul 19, 2013
A077011 001 Dec 26, 2006
A078287 001 Feb 22, 2013
A078945 001 Jan 03, 2013
A076972 001 Dec 26, 2006
A076780 001 Dec 26, 2006
A077541 001 Dec 26, 2006
A077548 001 Dec 26, 2006
A079032 001 Nov 18, 2008
A077551 001 Jun 27, 2007
A077173 001 Dec 26, 2006
A078014 001 Mar 21, 2008
A076759 001 Nov 22, 2006
A077716 001 Dec 26, 2006
N020007 001 Jan 04, 1991
N020007 003 Dec 10, 1993
A091483 001 Jan 31, 2011
A078127 001 Jun 25, 2007
A078776 001 Nov 28, 2007
A076960 001 Dec 26, 2006
A091342 001 Jan 27, 2011
A077009 001 Nov 30, 2007
N020605 001 Jan 24, 1997
A077306 001 Jun 25, 2007
A077306 002 Jun 25, 2007
A078539 001 Jul 31, 2007
A078539 002 Jul 31, 2007
A078539 003 Jul 31, 2007
A076183 003 Dec 26, 2006
A076183 002 Dec 26, 2006
A076183 001 Dec 26, 2006
A077535 001 Jun 25, 2007
A077535 002 Jun 25, 2007
A077535 003 Jun 25, 2007
A076930 001 Jun 25, 2007
A076930 002 Jun 25, 2007
A076930 004 Jun 25, 2007
A077851 001 Jun 25, 2007
A077851 002 Jun 25, 2007
A077112 001 Jun 25, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-270( of 362)
ONDANSETRON HYDROCHLORIDE
TABLET;ORAL
ONDANSETRON HYDROCHLORIDE
AB EQ 8MG BASE A077112 002 Jun 25, 2007
AB EQ 24MG BASE A077112 003 Jun 25, 2007
AB SANDOZ EQ 4MG BASE A077517 001 Jun 25, 2007
AB EQ 8MG BASE A077517 002 Jun 25, 2007
AB EQ 24MG BASE A077517 003 Jun 25, 2007
AB SUN PHARM INDS (IN) EQ 4MG BASE A077050 001 Jun 25, 2007
AB EQ 8MG BASE A077050 002 Jun 25, 2007
AB TEVA EQ 4MG BASE A076252 001 Jun 25, 2007
AB EQ 8MG BASE A076252 002 Jun 25, 2007
AB EQ 24MG BASE A076252 003 Jun 25, 2007
ZOFRAN
AB
AB
AB
GLAXOSMITHKLINE
+
ONDANSETRON HYDROCHLORIDE
EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE
N020103 001 Dec 31, 1992
N020103 002 Dec 31, 1992
N020103 003 Aug 27, 1999
DR REDDYS LABS LTD EQ 16MG BASE A076183 004 Dec 26, 2006
ORLISTAT
CAPSULE;ORAL
XENICAL
+ HOFFMANN LA ROCHE 120MG N020766 001 Apr 23, 1999
ORPHENADRINE CITRATE
INJECTABLE;INJECTION
NORFLEX
AP + MEDICIS 30MG/ML N013055 001
ORPHENADRINE CITRATE
AP AKORN 30MG/ML A040484 001 May 24, 2006
AP BEDFORD LABS 30MG/ML A040463 001 Mar 04, 2003
AP SAGENT PHARMS 30MG/ML A090585 001 Aug 30, 2011
AP WATSON LABS 30MG/ML A084779 001 Mar 15, 1982
AP 30MG/ML A087062 001
TABLET, EXTENDED RELEASE;ORAL
ORPHENADRINE CITRATE
AB GAVIS PHARMS 100MG A040284 001 Jun 19, 1998
AB IMPAX PHARMS 100MG A040368 001 Jun 23, 2000
AB INVAGEN PHARMS 100MG A091158 001 Jul 27, 2012
AB + SANDOZ 100MG A040327 001 Feb 15, 2000
AB TEDOR PHARMA INC 100MG A040249 001 Jan 29, 1999
OSELTAMIVIR PHOSPHATE
CAPSULE;ORAL
TAMIFLU
ROCHE EQ 30MG BASE N021087 003 Jul 02, 2007
EQ 45MG BASE N021087 002 Jul 02, 2007
+ EQ 75MG BASE N021087 001 Oct 27, 1999
FOR SUSPENSION;ORAL
TAMIFLU
+ ROCHE EQ 6MG BASE/ML N021246 002 Mar 21, 2011
OSPEMIFENE
TABLET;ORAL
OSPHENA
+ SHIONOGI INC 60MG N203505 001 Feb 26, 2013
OXACILLIN SODIUM
INJECTABLE;INJECTION
OXACILLIN SODIUM
AP AUROBINDO PHARMA LTD EQ 1GM BASE/VIAL A201539 001 Jan 18, 2013
AP EQ 2GM BASE/VIAL A201539 002 Jan 18, 2013
AP EQ 10GM BASE/VIAL A201538 001 Jan 18, 2013
AP SAGENT PHARMS EQ 1GM BASE/VIAL A091246 001 Mar 30, 2012
AP EQ 2GM BASE/VIAL A091246 002 Mar 30, 2012
AP EQ 10GM BASE/VIAL A091245 001 Mar 30, 2012
AP + SANDOZ EQ 1GM BASE/VIAL A061490 003
AP EQ 1GM BASE/VIAL A062737 001 Dec 23, 1986
AP + EQ 2GM BASE/VIAL A061490 004
AP EQ 2GM BASE/VIAL A062737 002 Dec 23, 1986
AP + EQ 10GM BASE/VIAL A061490 006 May 09, 1991
BACTOCILL IN PLASTIC CONTAINER
+ BAXTER HLTHCARE EQ 20MG BASE/ML N050640 001 Oct 26, 1989
+ EQ 40MG BASE/ML N050640 002 Oct 26, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-271( of 362)
OXALIPLATIN
INJECTABLE;IV (INFUSION)
ELOXATIN
AP + SANOFI AVENTIS US 50MG/10ML (5MG/ML) N021759 001 Jan 31, 2005
AP + 100MG/20ML (5MG/ML) N021759 002 Jan 31, 2005
OXALIPLATIN
AP ACTAVIS TOTOWA 50MG/VIAL A078803 001 Aug 08, 2012
AP 100MG/VIAL A078803 002 Aug 08, 2012
AP EBEWE PHARMA 50MG/10ML (5MG/ML) A078812 001 Aug 07, 2009
AP 100MG/20ML (5MG/ML) A078812 002 Aug 07, 2009
AP FRESENIUS KABI ONCOL 50MG/10ML (5MG/ML) A078811 001 Jun 10, 2010
AP 100MG/20ML (5MG/ML) A078811 002 Jun 10, 2010
AP 50MG/VIAL A078810 001 Aug 07, 2009
AP 100MG/VIAL A078810 002 Aug 07, 2009
AP FRESENIUS KABI USA 50MG/VIAL A078819 001 Jun 02, 2010
AP 100MG/VIAL A078819 002 Jun 02, 2010
AP HOSPIRA INC 50MG/VIAL A078815 001 Sep 30, 2009
AP 100MG/VIAL A078815 002 Sep 30, 2009
AP HOSPIRA WORLDWIDE 50MG/10ML (5MG/ML) A078813 001 Aug 07, 2009
AP 100MG/20ML (5MG/ML) A078813 002 Aug 07, 2009
AP ONCO THERAPIES LTD 50MG/10ML (5MG/ML) A091358 001 Aug 07, 2012
AP 50MG/VIAL A200979 001 Aug 08, 2012
AP 100MG/20ML (5MG/ML) A091358 002 Aug 07, 2012
AP 100MG/VIAL A200979 002 Aug 08, 2012
AP SANDOZ 50MG/10ML (5MG/ML) A078817 001 Jan 24, 2011
AP 100MG/20ML (5MG/ML) A078817 002 Jan 24, 2011
AP + SUN PHARMA GLOBAL 50MG/VIAL A078818 001 Aug 07, 2009
AP + 100MG/VIAL A078818 002 Aug 07, 2009
AP + TEVA PHARMS 50MG/10ML (5MG/ML) N022160 001 Aug 07, 2009
AP + 100MG/20ML (5MG/ML) N022160 002 Aug 07, 2009
ELOXATIN
+ SANOFI AVENTIS US 200MG/40ML (5MG/ML) N021759 003 Nov 17, 2006
OXANDROLONE
TABLET;ORAL
OXANDRIN
AB SAVIENT PHARMS 2.5MG N013718 001
AB + 10MG N013718 002 Nov 05, 2001
OXANDROLONE
AB PAR PHARM 2.5MG A077827 001 Jun 22, 2007
AB 10MG A077827 002 Jun 22, 2007
AB UPSHER SMITH 2.5MG A076761 001 Dec 01, 2006
AB 10MG A078033 001 Mar 22, 2007
OXAPROZIN
TABLET;ORAL
DAYPRO
AB + GD SEARLE 600MG N018841 004 Oct 29, 1992
OXAPROZIN
AB APOTEX INC 600MG A075987 001 Sep 02, 2004
AB CARACO 600MG A075844 001 Jan 03, 2002
AB DR REDDYS LABS LTD 600MG A075855 001 Jan 31, 2001
AB IVAX SUB TEVA PHARMS 600MG A075846 001 May 13, 2002
AB SANDOZ 600MG A075845 001 Jan 31, 2001
AB TEVA 600MG A075849 001 Jul 03, 2002
AB WATSON LABS 600MG A075848 001 Feb 09, 2001
OXAZEPAM
CAPSULE;ORAL
OXAZEPAM
AB ACTAVIS ELIZABETH 10MG A072251 001 Apr 14, 1988
AB 15MG A072252 001 Apr 14, 1988
AB + 30MG A072253 001 Apr 14, 1988
AB IVAX SUB TEVA PHARMS 10MG A070943 001 Aug 03, 1987
AB 15MG A070944 001 Aug 03, 1987
AB 30MG A070945 001 Aug 03, 1987
AB SANDOZ 10MG A071813 001 Apr 19, 1988
AB 15MG A071756 001 Apr 19, 1988
AB 30MG A071814 001 Apr 19, 1988
AB WATSON LABS 10MG A072952 001 Sep 28, 1990
AB 15MG A072953 001 Sep 28, 1990
AB 30MG A072954 001 Sep 28, 1990
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-272( of 362)
OXCARBAZEPINE
SUSPENSION;ORAL
OXCARBAZEPINE
AB AMNEAL PHARMS 300MG/5ML A202961 001 Sep 17, 2012
AB RANBAXY 300MG/5ML A078734 001 Jun 26, 2009
AB ROXANE 300MG/5ML A201193 001 Oct 03, 2012
TRILEPTAL
AB + NOVARTIS 300MG/5ML N021285 001 May 25, 2001
TABLET;ORAL
OXCARBAZEPINE
AB APOTEX INC 150MG A077747 001 Apr 09, 2008
AB 300MG A077747 002 Apr 09, 2008
AB 600MG A077747 003 Apr 09, 2008
AB BRECKENRIDGE PHARM 150MG A078069 001 Jan 11, 2008
AB 300MG A078069 002 Jan 11, 2008
AB 600MG A078069 003 Jan 11, 2008
AB CADISTA PHARMS 150MG A090239 001 Jan 25, 2010
AB 300MG A090239 002 Jan 25, 2010
AB 600MG A090239 003 Jan 25, 2010
AB GLENMARK GENERICS 150MG A077802 001 Oct 09, 2007
AB 300MG A077802 002 Oct 09, 2007
AB 600MG A077802 003 Oct 09, 2007
AB ROXANE 150MG A077795 001 Oct 09, 2007
AB 300MG A077795 002 Oct 09, 2007
AB 600MG A077795 003 Oct 09, 2007
AB SUN PHARM INDS 150MG A077794 001 Oct 09, 2007
AB 300MG A077794 002 Oct 09, 2007
AB 600MG A077794 003 Oct 09, 2007
AB TARO 150MG A077801 001 Nov 15, 2007
AB 300MG A077801 002 Nov 15, 2007
AB 600MG A077801 003 Nov 15, 2007
TRILEPTAL
AB NOVARTIS 150MG N021014 001 Jan 14, 2000
AB 300MG N021014 002 Jan 14, 2000
AB + 600MG N021014 003 Jan 14, 2000
TABLET, EXTENDED RELEASE;ORAL
OXTELLAR XR
SUPERNUS PHARMS 150MG N202810 001 Oct 19, 2012
300MG N202810 002 Oct 19, 2012
+ 600MG N202810 003 Oct 19, 2012
OXICONAZOLE NITRATE
CREAM;TOPICAL
OXISTAT
+ FOUGERA PHARMS EQ 1% BASE N019828 001 Dec 30, 1988
LOTION;TOPICAL
OXISTAT
+ FOUGERA PHARMS EQ 1% BASE N020209 001 Sep 30, 1992
OXTRIPHYLLINE
TABLET, EXTENDED RELEASE;ORAL
CHOLEDYL SA
+ WARNER CHILCOTT LLC 400MG A087863 001 May 24, 1983
+ 600MG A086742 001
OXYBUTYNIN
FILM, EXTENDED RELEASE;TRANSDERMAL
OXYTROL
+ WATSON LABS (UTAH) 3.9MG/24HR N021351 002 Feb 26, 2003
GEL, METERED;TRANSDERMAL
GELNIQUE 3%
+ WATSON LABS INC 3% N202513 001 Dec 07, 2011
OXYBUTYNIN CHLORIDE
GEL;TRANSDERMAL
GELNIQUE
+ WATSON LABS 10%(100MG/PACKET) N022204 001 Jan 27, 2009
SYRUP;ORAL
OXYBUTYNIN CHLORIDE
AA PHARM ASSOC 5MG/5ML A075137 001 Dec 18, 1998
AA SILARX 5MG/5ML A074520 001 Mar 29, 1996
AA VINTAGE PHARMS 5MG/5ML A076682 001 Dec 28, 2004
AA + WOCKHARDT 5MG/5ML A074868 001 Feb 12, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
OXYBUTYNIN CHLORIDE
TABLET;ORAL
OXYBUTYNIN CHLORIDE
AB TEVA PHARMS USA
AB USL PHARMA
AB + VINTAGE PHARMS
TABLET, EXTENDED RELEASE;ORAL
DITROPAN XL
AB JANSSEN PHARMS
AB
AB +
OXYBUTYNIN CHLORIDE
AB IMPAX PHARMS
AB
AB
AB MYLAN
AB MYLAN PHARMS INC
AB
AB OSMOTICA PHARM
AB
AB
OXYCODONE HYDROCHLORIDE
CAPSULE;ORAL
OXYCODONE HYDROCHLORIDE
AB COASTAL PHARMS
AB + LEHIGH VALLEY
SOLUTION;ORAL
OXYCODONE HYDROCHLORIDE
AA + LEHIGH VALLEY
AA ROXANE
AA
AA + VISTAPHARM
AA
TABLET;ORAL
OXYCODONE HYDROCHLORIDE
AB ACTAVIS TOTOWA
AB
AB ALVOGEN INC
AB
AB
AB AUROLIFE PHARMA LLC
AB
AB
AB AVANTHI INC
AB
AB
AB
AB
AB COASTAL PHARMS
AB
AB
AB COREPHARMA
AB
AB
AB MALLINCKRODT INC
AB
AB
AB NESHER PHARMS
AB
AB
AB
AB
AB RHODES PHARMS
AB
AB
AB
AB
AB SUN PHARM INDS INC
AB
AB
AB
AB
5MG
5MG
5MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
5MG
100MG/5ML
5MG/5ML
100MG/5ML
5MG/5ML
100MG/5ML
15MG
30MG
5MG
15MG
30MG
5MG
15MG
30MG
5MG
10MG
15MG
20MG
30MG
5MG
15MG
30MG
5MG
15MG
30MG
5MG
15MG
30MG
5MG
10MG
15MG
20MG
30MG
5MG
10MG
15MG
20MG
30MG
5MG
10MG
15MG
20MG
30MG
3-273( of 362)
A071655 001 Nov 14, 1988
A074625 001 Jul 31, 1996
A075079 001 Oct 31, 1997
N020897 001 Dec 16, 1998
N020897 002 Dec 16, 1998
N020897 003 Jun 22, 1999
A076745 002 May 09, 2007
A076745 003 May 09, 2007
A076745 001 Nov 09, 2006
A076702 001 Nov 09, 2006
A076644 001 Nov 09, 2006
A076644 002 May 10, 2007
A078503 001 Feb 04, 2009
A078503 002 Feb 04, 2009
A078503 003 Feb 04, 2009
A203107 001 Jul 26, 2012
N200534 001 Oct 20, 2010
N200535 001 Oct 20, 2010
A204037 001 Jul 15, 2013
A203208 001 Jul 12, 2013
N201194 001 Jan 12, 2012
A202537 001 Jul 30, 2012
A076636 001 Feb 06, 2004
A076636 002 Feb 06, 2004
A202116 001 Dec 30, 2011
A202116 002 Dec 30, 2011
A202116 003 Dec 30, 2011
A202160 001 Nov 19, 2012
A202160 002 Nov 19, 2012
A202160 003 Nov 19, 2012
A091393 001 Aug 31, 2009
A091393 002 Aug 31, 2009
A091393 003 Aug 31, 2009
A091393 004 Aug 31, 2009
A091393 005 Aug 31, 2009
A091313 001 Feb 18, 2011
A091313 002 Feb 18, 2011
A091313 003 Feb 18, 2011
A090895 001 Aug 24, 2009
A090895 002 Aug 24, 2009
A090895 003 Aug 24, 2009
A076758 003 Mar 19, 2007
A076758 001 Jun 30, 2004
A076758 002 Jun 30, 2004
A077290 001 Dec 08, 2005
A077290 002 Dec 08, 2005
A077290 003 Dec 08, 2005
A077290 004 Dec 08, 2005
A077290 005 Dec 08, 2005
A091490 001 Mar 09, 2011
A091490 002 Mar 09, 2011
A091490 003 Mar 09, 2011
A091490 004 Mar 09, 2011
A091490 005 Mar 09, 2011
A090659 001 Apr 10, 2009
A090659 005 Nov 06, 2012
A090659 002 Apr 10, 2009
A090659 004 Nov 06, 2012
A090659 003 Apr 10, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-274( of 362)
OXYCODONE HYDROCHLORIDE
TABLET;ORAL
OXYCODONE HYDROCHLORIDE
AB VINTAGE PHARMS 5MG A077712 003 Mar 02, 2009
AB 15MG A077712 001 Jan 31, 2007
AB 30MG A077712 002 Jan 31, 2007
ROXICODONE
AB MALLINCKRODT INC 5MG N021011 003 May 15, 2009
AB + 15MG N021011 001 Aug 31, 2000
AB 30MG N021011 002 Aug 31, 2000
OXECTA
KING PHARMS R AND D 5MG N202080 001 Jun 17, 2011
7.5MG N202080 002 Jun 17, 2011
TABLET, EXTENDED RELEASE;ORAL
OXYCONTIN
PURDUE PHARMA LP 10MG N022272 001 Apr 05, 2010
15MG N022272 002 Apr 05, 2010
20MG N022272 003 Apr 05, 2010
30MG N022272 004 Apr 05, 2010
+ 40MG N022272 005 Apr 05, 2010
60MG N022272 006 Apr 05, 2010
80MG N022272 007 Apr 05, 2010
OXYMETHOLONE
TABLET;ORAL
ANADROL-50
+ MEDA PHARMS 50MG N016848 001
OXYMORPHONE HYDROCHLORIDE
INJECTABLE;INJECTION
OPANA
+ ENDO PHARMS 1MG/ML N011707 002
TABLET;ORAL
OPANA
AB ENDO PHARMS 5MG N021611 001 Jun 22, 2006
AB + 10MG N021611 002 Jun 22, 2006
OXYMORPHONE HYDROCHLORIDE
AB AVANTHI INC 5MG A203601 001 Jan 30, 2013
AB 10MG A203601 002 Jan 30, 2013
AB MALLINCKRODT INC 5MG A202321 001 Apr 25, 2013
AB 10MG A202321 002 Apr 25, 2013
AB ROXANE 5MG A090964 001 Sep 27, 2010
AB 10MG A090964 002 Sep 27, 2010
AB TEVA 5MG A091443 002 Feb 15, 2011
AB 10MG A091443 001 Feb 15, 2011
TABLET, EXTENDED RELEASE;ORAL
OXYMORPHONE HYDROCHLORIDE
AB ACTAVIS ELIZABETH 5MG A079046 003 Jul 11, 2013
AB 7.5MG A079046 001 Dec 13, 2010
AB 10MG A079046 004 Jul 11, 2013
AB 15MG A079046 002 Dec 13, 2010
AB 20MG A079046 005 Jul 11, 2013
AB 30MG A079046 006 Jul 11, 2013
AB 40MG A079046 007 Jul 11, 2013
AB IMPAX LABS 5MG A079087 001 Jun 14, 2010
AB 7.5MG A079087 002 Dec 21, 2010
AB 10MG A079087 003 Jun 14, 2010
AB 15MG A079087 004 Dec 21, 2010
AB 20MG A079087 005 Jun 14, 2010
AB 30MG A079087 006 Jul 22, 2010
AB 40MG A079087 007 Jun 14, 2010
AB ROXANE 5MG A200822 002 Jul 15, 2013
AB 7.5MG A200822 003 Jul 15, 2013
AB 10MG A200822 004 Jul 15, 2013
AB 15MG A200822 005 Jul 15, 2013
AB 20MG A200822 006 Jul 15, 2013
AB 30MG A200822 007 Jul 15, 2013
AB 40MG A200822 001 Jul 15, 2013
OPANA ER
ENDO PHARMS 5MG N201655 001 Dec 09, 2011
7.5MG N201655 002 Dec 09, 2011
10MG N201655 003 Dec 09, 2011
15MG N201655 004 Dec 09, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-275( of 362)
OXYMORPHONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
OPANA ER
20MG N201655 005 Dec 09, 2011
30MG N201655 006 Dec 09, 2011
+ 40MG N201655 007 Dec 09, 2011
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
TERRAMYCIN W/ POLYMYXIN B SULFATE
+ PFIZER EQ 5MG BASE/GM;10,000 UNITS/GM A061015 001
OXYTOCIN
INJECTABLE;INJECTION
OXYTOCIN
AP + BAXTER HLTHCARE CORP 10USP UNITS/ML (10USP UNITS/ML) N018243 001
AP + 100USP UNITS/10ML (10USP UNITS/ML) N018243 002 Jan 10, 2007
AP + FRESENIUS KABI USA 10USP UNITS/ML (10USP UNITS/ML) N018248 001
AP + 100USP UNITS/10ML (10USP UNITS/ML) N018248 002
AP HIKMA FARMACEUTICA 10USP UNITS/ML (10USP UNITS/ML) A200219 001 Feb 13, 2013
PITOCIN
AP + JHP PHARMS 10USP UNITS/ML (10USP UNITS/ML) N018261 001
AP 100USP UNITS/10ML (10USP UNITS/ML) N018261 002 Jul 27, 2007
OXYTOCIN
+ FRESENIUS KABI USA 300USP UNITS/30ML (10USP UNITS/ML) N018248 003 Jul 27, 2007
PITOCIN
JHP PHARMS 500USP UNITS/50ML (10USP UNITS/ML) N018261 003 Sep 05, 2012
PACLITAXEL
FOR SUSPENSION;IV (INFUSION)
ABRAXANE
+ ABRAXIS BIOSCIENCE 100MG/VIAL N021660 001 Jan 07, 2005
INJECTABLE;INJECTION
PACLITAXEL
AP ACTAVIS TOTOWA 6MG/ML A090130 001 Dec 09, 2009
AP BEDFORD 6MG/ML A075190 001 Jan 28, 2002
AP EBEWE PHARMA 6MG/ML A078167 001 Dec 26, 2007
AP FRESENIUS KABI ONCOL 6MG/ML A077574 001 Nov 27, 2006
AP + HOSPIRA 6MG/ML A076131 001 May 08, 2002
AP MYLAN 6MG/ML A075278 001 Jan 25, 2002
AP ONCO THERAPIES LTD 6MG/ML A091540 001 Sep 29, 2011
AP TEVA PHARMS 6MG/ML A075184 001 Jan 25, 2002
TAXOL
AP HQ SPCLT PHARMA 6MG/ML N020262 001 Dec 29, 1992
PALIPERIDONE
TABLET, EXTENDED RELEASE;ORAL
INVEGA
JANSSEN PHARMS 1.5MG N021999 006 Aug 26, 2008
3MG N021999 001 Dec 19, 2006
+ 6MG N021999 002 Dec 19, 2006
9MG N021999 003 Dec 19, 2006
PALIPERIDONE PALMITATE
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
INVEGA SUSTENNA
JANSSEN PHARMS 39MG/0.25ML (39MG/0.25ML) N022264 001 Jul 31, 2009
78MG/0.5ML (78MG/0.5ML) N022264 002 Jul 31, 2009
+ 117MG/0.75ML (117MG/0.75ML) N022264 003 Jul 31, 2009
156MG/ML (156MG/ML) N022264 004 Jul 31, 2009
234MG/1.5ML (156MG/ML) N022264 005 Jul 31, 2009
PALONOSETRON HYDROCHLORIDE
INJECTABLE;INTRAVENOUS
ALOXI
+ HELSINN HLTHCARE EQ 0.075MG BASE/1.5ML (EQ 0.05MG N021372 002 Feb 29, 2008
BASE/ML)
+ EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) N021372 001 Jul 25, 2003
PAMIDRONATE DISODIUM
INJECTABLE;INJECTION
PAMIDRONATE DISODIUM
AP AGILA SPECLTS 30MG/10ML (3MG/ML) A078520 001 Oct 31, 2008
AP 90MG/10ML (9MG/ML) A078520 002 Oct 31, 2008
AP AREVA PHARMS 30MG/VIAL A077433 001 Nov 26, 2008
AP 60MG/VIAL A077433 002 Nov 26, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-276( of 362)
PAMIDRONATE DISODIUM
INJECTABLE;INJECTION
PAMIDRONATE DISODIUM
AP 90MG/VIAL A077433 003 Nov 26, 2008
AP BEDFORD 30MG/VIAL A075290 001 Apr 30, 2001
AP + 30MG/10ML (3MG/ML) N021113 001 Mar 04, 2002
AP 90MG/VIAL A075290 003 Apr 30, 2001
AP + 90MG/10ML (9MG/ML) N021113 002 Mar 04, 2002
AP FRESENIUS KABI USA 30MG/VIAL A075773 001 May 06, 2002
AP 30MG/10ML (3MG/ML) A076207 001 May 17, 2002
AP 90MG/VIAL A075773 002 May 06, 2002
AP 90MG/10ML (9MG/ML) A076207 002 May 17, 2002
AP + HOSPIRA 30MG/10ML (3MG/ML) A075841 001 Jun 27, 2002
AP + 60MG/10ML (6MG/ML) A075841 002 Jun 27, 2002
AP + 90MG/10ML (9MG/ML) A075841 003 Jun 27, 2002
AP LUITPOLD 30MG/10ML (3MG/ML) A078942 001 Jul 25, 2008
AP 90MG/10ML (9MG/ML) A078942 002 Jul 25, 2008
AP MN PHARMS 30MG/VIAL A078300 001 Mar 10, 2009
AP 90MG/VIAL A078300 002 Mar 10, 2009
AP MUSTAFA NEVZAT 30MG/10ML (3MG/ML) A078373 001 Dec 23, 2008
AP 90MG/10ML (9MG/ML) A078373 002 Dec 23, 2008
AP PLIVA LACHEMA 30MG/10ML (3MG/ML) A078156 001 Aug 19, 2008
AP 60MG/10ML (6MG/ML) A078156 002 Aug 19, 2008
AP 90MG/10ML (9MG/ML) A078156 003 Aug 19, 2008
AP SUN PHARMA GLOBAL 30MG/VIAL A077703 001 Dec 24, 2008
AP 90MG/VIAL A077703 002 Dec 24, 2008
AP TEVA PHARMS USA 30MG/10ML (3MG/ML) A076153 001 Mar 27, 2002
AP 90MG/10ML (9MG/ML) A076153 002 Mar 27, 2002
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE, DELAYED RELEASE;ORAL
CREON
ABBVIE 12,000USP UNITS\;38,000USP N020725 002 Apr 30, 2009
UNITS\;60,000USP UNITS\
15,000USP UNITS\;3,000USP N020725 004 Jul 12, 2011
UNITS\;9,500USP UNITS\
19,000USP UNITS\;30,000USP N020725 001 Apr 30, 2009
UNITS\;6,000USP UNITS\
114,000USP UNITS;180,000USP N020725 005 Mar 14, 2013
UNITS;36,000USP UNITS
+ 120,000USP UNITS\;24,000USP N020725 003 Apr 30, 2009
UNITS\;76,000USP UNITS\
PANCREAZE
JANSSEN PHARMS 10,000USP/ UNITS;17,500USP/ N022523 001 Apr 12, 2010
UNITS;4,200USP/ UNITS
10,500USP/ UNITS;25,000USP/ N022523 002 Apr 12, 2010
UNITS;43,750USP/ UNITS
16,800USP/ UNITS;40,000USP/ N022523 004 Apr 12, 2010
UNITS;70,000USP/ UNITS
+ 21,000USP/ UNITS;37,000USP/ N022523 003 Apr 12, 2010
UNITS;61,000USP/ UNITS
PERTZYE
DIGESTIVE CARE INC 30,250USP/UNITS;8,000USP/UNITS;28,750US N022175 001 May 17, 2012
P/UNITS
+ 60,500USP/UNITS;16,000USP/UNITS;57,500U N022175 002 May 17, 2012
SP/UNITS
ULTRESA
APTALIS PHARMA US 13,800USP UNITS;27,600USP N022222 001 Mar 01, 2012
UNITS;27,600USP UNITS
20,700USP UNITS;41,400USP N022222 002 Mar 01, 2012
UNITS;41,400USP UNITS
+ 23,000USP UNITS;46,000USP N022222 003 Mar 01, 2012
UNITS;46,000USP UNITS
ZENPEP
APTALIS PHARMA US 10,000USP UNITS;16,000USP N022210 005 Jun 15, 2011
UNITS;3,000USP UNITS
10,000USP UNITS;34,000USP N022210 002 Aug 27, 2009
UNITS;55,000USP UNITS
15,000USP UNITS;51,000USP N022210 003 Aug 27, 2009
UNITS;82,000USP UNITS
17,000USP UNITS;27,000USP N022210 001 Aug 27, 2009
UNITS;5,000USP UNITS
109,000USP UNITS;20,000USP N022210 004 Aug 27, 2009
UNITS;68,000USP UNITS
+ 136,000USP UNITS;25,000USP N022210 006 Jul 13, 2011
UNITS;85,000USP UNITS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-277( of 362)
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
TABLET;ORAL
VIOKACE
APTALIS PHARMA US 10440USPU;39150USPU;39150USPU N022542 001 Mar 01, 2012
+ 20880USPU;78300USPU;78300USPU N022542 002 Mar 01, 2012
PANCURONIUM BROMIDE
INJECTABLE;INJECTION
PANCURONIUM BROMIDE
AP HOSPIRA 1MG/ML A072320 001 Jan 19, 1989
AP + TEVA PHARMS USA 1MG/ML A072759 001 Jul 31, 1990
AP + 2MG/ML A072760 001 Jul 31, 1990
PANTOPRAZOLE SODIUM
FOR SUSPENSION, DELAYED RELEASE;ORAL
PROTONIX
+ WYETH PHARMS INC EQ 40MG BASE N022020 001 Nov 14, 2007
INJECTABLE;IV (INFUSION)
PANTOPRAZOLE SODIUM
AP AKORN INC EQ 40MG BASE/VIAL A079197 001 Nov 08, 2012
PROTONIX IV
AP + WYETH PHARMS INC EQ 40MG BASE/VIAL N020988 001 Mar 22, 2001
TABLET, DELAYED RELEASE;ORAL
PANTOPRAZOLE SODIUM
AB ACTAVIS TOTOWA EQ 20MG BASE A090797 001 Feb 07, 2011
AB EQ 40MG BASE A090797 002 Feb 07, 2011
AB APOTEX INC EQ 20MG BASE A090807 001 May 02, 2012
AB EQ 40MG BASE A090807 002 May 02, 2012
AB AUROBINDO PHARMA LTD EQ 20MG BASE A202038 001 Sep 28, 2012
AB EQ 40MG BASE A202038 002 Sep 28, 2012
AB DR REDDYS LABS LTD EQ 20MG BASE A077619 001 Jan 19, 2011
AB EQ 40MG BASE A077619 002 Jan 19, 2011
AB JUBILANT ORGANOSYS EQ 20MG BASE A090901 001 Aug 30, 2011
AB EQ 40MG BASE A090901 002 Aug 30, 2011
AB KUDCO IRELAND EQ 20MG BASE A078281 001 Jan 20, 2011
AB EQ 40MG BASE A078281 002 Jan 20, 2011
AB MACLEODS PHARMS LTD EQ 20MG BASE A200821 001 Feb 16, 2012
AB EQ 40MG BASE A200821 002 Feb 16, 2012
AB MYLAN PHARMS INC EQ 20MG BASE A090970 001 Jan 19, 2011
AB EQ 40MG BASE A090970 002 Jan 19, 2011
AB RANBAXY LABS LTD EQ 20MG BASE A200794 001 May 02, 2012
AB EQ 40MG BASE A200794 002 May 02, 2012
AB SUN PHARMA GLOBAL EQ 20MG BASE A077058 001 Sep 10, 2007
AB EQ 40MG BASE A077058 002 Sep 10, 2007
AB TEVA EQ 20MG BASE A077056 001 Aug 02, 2007
AB EQ 40MG BASE A077056 002 Aug 02, 2007
AB TORRENT PHARMS EQ 20MG BASE A090074 001 Jan 19, 2011
AB EQ 40MG BASE A090074 002 Jan 19, 2011
AB WOCKHARDT EQ 20MG BASE A091231 001 Jan 19, 2011
AB EQ 40MG BASE A091231 002 Jan 19, 2011
PROTONIX
AB WYETH PHARMS INC EQ 20MG BASE N020987 002 Jun 12, 2001
AB + EQ 40MG BASE N020987 001 Feb 02, 2000
PARICALCITOL
CAPSULE;ORAL
PARICALCITOL
AB TEVA PHARMS USA 1MCG A090829 001 Sep 27, 2013
AB 2MCG A090829 002 Sep 27, 2013
AB 4MCG A090829 003 Sep 27, 2013
ZEMPLAR
AB ABBVIE 1MCG N021606 001 May 26, 2005
AB 2MCG N021606 002 May 26, 2005
AB + 4MCG N021606 003 May 26, 2005
INJECTABLE;INJECTION
PARICALCITOL
AP SANDOZ CANADA INC 0.002MG/ML A091108 001 Jul 27, 2011
AP 0.005MG/ML A091108 002 Jul 27, 2011
ZEMPLAR
AP + ABBVIE 0.002MG/ML N020819 002 Feb 01, 2000
AP + 0.005MG/ML N020819 001 Apr 17, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-278( of 362)
PAROMOMYCIN SULFATE
CAPSULE;ORAL
PAROMOMYCIN SULFATE
AA + CARACO EQ 250MG BASE A064171 001 Jun 30, 1997
AA HERITAGE PHARMS INC EQ 250MG BASE A065173 001 Dec 14, 2007
PAROXETINE HYDROCHLORIDE
SUSPENSION;ORAL
PAXIL
AB + GLAXOSMITHKLINE EQ 10MG BASE/5ML N020710 001 Jun 25, 1997
TABLET;ORAL
PAROXETINE HYDROCHLORIDE
AB APOTEX EQ 10MG BASE A075356 001 Jul 30, 2003
AB EQ 20MG BASE A075356 002 Jul 30, 2003
AB EQ 30MG BASE A075356 003 Jul 30, 2003
AB EQ 40MG BASE A075356 004 Jul 30, 2003
AB AUROBINDO PHARMA EQ 10MG BASE A078406 001 Jul 25, 2007
AB EQ 20MG BASE A078406 002 Jul 25, 2007
AB EQ 30MG BASE A078406 003 Jul 25, 2007
AB EQ 40MG BASE A078406 004 Jul 25, 2007
AB CARACO EQ 10MG BASE A078194 001 Jun 29, 2007
AB EQ 20MG BASE A078194 002 Jun 29, 2007
AB EQ 30MG BASE A078194 003 Jun 29, 2007
AB EQ 40MG BASE A078194 004 Jun 29, 2007
AB MYLAN EQ 10MG BASE A078902 001 Mar 13, 2008
AB EQ 20MG BASE A078902 002 Mar 13, 2008
AB EQ 30MG BASE A078902 003 Mar 13, 2008
AB EQ 40MG BASE A078902 004 Mar 13, 2008
AB MYLAN PHARMS INC EQ 10MG BASE A075716 001 Mar 08, 2004
AB EQ 20MG BASE A075716 002 Mar 08, 2004
AB EQ 30MG BASE A075716 003 Mar 08, 2004
AB EQ 40MG BASE A075716 004 Mar 08, 2004
AB PROSAM LABS EQ 10MG BASE A076968 001 Jun 21, 2010
AB EQ 20MG BASE A076968 002 Jun 21, 2010
AB EQ 30MG BASE A076968 003 Jun 21, 2010
AB EQ 40MG BASE A076968 004 Jun 21, 2010
AB TEVA EQ 10MG BASE A076618 001 Aug 15, 2005
AB EQ 20MG BASE A076618 002 Aug 15, 2005
AB EQ 30MG BASE A076618 003 Aug 15, 2005
AB EQ 40MG BASE A076618 004 Aug 15, 2005
AB ZYDUS PHARMS USA EQ 10MG BASE A077584 001 Mar 07, 2007
AB EQ 20MG BASE A077584 002 Mar 07, 2007
AB EQ 30MG BASE A077584 003 Mar 07, 2007
AB EQ 40MG BASE A077584 004 Mar 07, 2007
PAXIL
AB GLAXOSMITHKLINE EQ 10MG BASE N020031 001 Dec 29, 1992
AB EQ 20MG BASE N020031 002 Dec 29, 1992
AB EQ 30MG BASE N020031 003 Dec 29, 1992
AB + EQ 40MG BASE N020031 005 Dec 29, 1992
TABLET, EXTENDED RELEASE;ORAL
PAROXETINE HYDROCHLORIDE
AB MYLAN EQ 12.5MG BASE A077873 001 Jun 29, 2007
AB EQ 25MG BASE A077873 002 Jun 29, 2007
AB EQ 37.5MG BASE A091427 001 Apr 14, 2011
PAXIL CR
AB GLAXOSMITHKLINE EQ 12.5MG BASE N020936 001 Feb 16, 1999
AB EQ 25MG BASE N020936 002 Feb 16, 1999
AB + EQ 37.5MG BASE N020936 003 Dec 06, 2000
PAROXETINE MESYLATE
CAPSULE;ORAL
BRISDELLE
+ NOVEN THERAP EQ 7.5MG BASE N204516 001 Jun 28, 2013
TABLET;ORAL
PEXEVA
NOVEN THERAP EQ 10MG BASE N021299 001 Jul 03, 2003
EQ 20MG BASE N021299 002 Jul 03, 2003
EQ 30MG BASE N021299 003 Jul 03, 2003
+ EQ 40MG BASE N021299 004 Jul 03, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
PASIREOTIDE DIASPARTATE
SOLUTION;SUBCUTANEOUS
SIGNIFOR
NOVARTIS
+
PAZOPANIB HYDROCHLORIDE
TABLET;ORAL
VOTRIENT
+ GLAXOSMITHKLINE
PEGADEMASE BOVINE
INJECTABLE;INJECTION
ADAGEN
+ SIGMA TAU
PEGAPTANIB SODIUM
INJECTABLE;INTRAVITREAL
MACUGEN
+ VALEANT PHARMS LLC
PEGVISOMANT
INJECTABLE;SUBCUTANEOUS
SOMAVERT
+ PHARMACIA AND UPJOHN
+
+
PEMETREXED DISODIUM
INJECTABLE;IV (INFUSION)
ALIMTA
+ LILLY
+
PEMIROLAST POTASSIUM
SOLUTION/DROPS;OPHTHALMIC
ALAMAST
+ SANTEN
PENBUTOLOL SULFATE
TABLET;ORAL
LEVATOL
+ ACTIENT PHARMS
PENCICLOVIR SODIUM
CREAM;TOPICAL
DENAVIR
+ DENCO ASSET
PENICILLAMINE
CAPSULE;ORAL
CUPRIMINE
+ ATON
TABLET;ORAL
DEPEN
+ MEDA PHARMS
PENICILLIN G BENZATHINE
INJECTABLE;INJECTION
BICILLIN L-A
BC + KING PHARMS
PERMAPEN
BC PFIZER
BICILLIN L-A
+ KING PHARMS
EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)
EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)
EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)
EQ 200MG BASE
EQ 400MG BASE
250 UNITS/ML
EQ 0.3MG ACID/0.09ML
10MG/VIAL
15MG/VIAL
20MG/VIAL
EQ 100MG BASE/VIAL
EQ 500MG BASE/VIAL
0.1%
20MG
1%
250MG
250MG
600,000 UNITS/ML
600,000 UNITS/ML
300,000 UNITS/ML
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
INJECTABLE;INJECTION
BICILLIN C-R
+ KING PHARMS
+
BICILLIN C-R 900/300
+ KING PHARMS
150,000 UNITS/ML;150,000 UNITS/ML
300,000 UNITS/ML;300,000 UNITS/ML
900,000 UNITS/2ML;300,000 UNITS/2ML
3-279( of 362)
N200677 001 Dec 14, 2012
N200677 002 Dec 14, 2012
N200677 003 Dec 14, 2012
N022465 001 Oct 19, 2009
N022465 002 Oct 19, 2009
N019818 001 Mar 21, 1990
N021756 001 Dec 17, 2004
N021106 001 Mar 25, 2003
N021106 002 Mar 25, 2003
N021106 003 Mar 25, 2003
N021462 002 Sep 07, 2007
N021462 001 Feb 04, 2004
N021079 001 Sep 24, 1999
N018976 004 Jan 05, 1989
N020629 001 Sep 24, 1996
N019853 001
N019854 001
N050141 001
A060014 001
N050141 003
N050138 002
N050138 001
N050138 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-280( of 362)
PENICILLIN G POTASSIUM
INJECTABLE;INJECTION
PENICILLIN G POTASSIUM
AP HANFORD GC 5,000,000 UNITS/VIAL A065149 002 Jul 23, 2009
AP 20,000,000 UNITS/VIAL A065149 003 Jul 23, 2009
AP IBI 5,000,000 UNITS/VIAL A065448 001 Aug 18, 2009
AP 20,000,000 UNITS/VIAL A065448 002 Aug 18, 2009
AP SANDOZ 5,000,000 UNITS/VIAL A065079 002 Aug 30, 2002
AP 20,000,000 UNITS/VIAL A065079 003 Aug 30, 2002
PFIZERPEN
AP + PFIZER 5,000,000 UNITS/VIAL A060657 002
AP + 20,000,000 UNITS/VIAL A060657 003
PENICILLIN G POTASSIUM
HANFORD GC 1,000,000 UNITS/VIAL A065149 001 Jul 23, 2009
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 20,000 UNITS/ML N050638 001 Jun 25, 1990
+ 40,000 UNITS/ML N050638 002 Jun 25, 1990
+ 60,000 UNITS/ML N050638 003 Jun 25, 1990
PENICILLIN G PROCAINE
INJECTABLE;INJECTION
PENICILLIN G PROCAINE
+ KING PHARMS 300,000 UNITS/ML A060101 002
+ 600,000 UNITS/ML A060101 001
PENICILLIN G SODIUM
INJECTABLE;IM-IV
PENICILLIN G SODIUM
+ SANDOZ 5,000,000 UNITS/VIAL A065068 001 Feb 26, 2001
PENICILLIN V POTASSIUM
FOR SOLUTION;ORAL
PENICILLIN V POTASSIUM
AA DAVA PHARMS INC EQ 125MG BASE/5ML A062981 001 Feb 10, 1989
AA EQ 250MG BASE/5ML A062981 002 Feb 10, 1989
PENICILLIN-VK
AA TEVA EQ 125MG BASE/5ML A060456 001
AA + EQ 250MG BASE/5ML A060456 002
TABLET;ORAL
PENICILLIN V POTASSIUM
AB AUROBINDO PHARMA EQ 250MG BASE A065435 001 Apr 29, 2008
AB EQ 500MG BASE A065435 002 Apr 29, 2008
AB DAVA PHARMS INC EQ 250MG BASE A062936 001 Nov 25, 1988
AB EQ 500MG BASE A062935 001 Nov 23, 1988
AB HIKMA PHARMS EQ 250MG BASE A090549 001 Oct 11, 2013
AB EQ 500MG BASE A090549 002 Oct 11, 2013
AB SANDOZ EQ 250MG BASE A064071 001 Nov 30, 1995
AB + EQ 500MG BASE A064071 002 Nov 30, 1995
PENICILLIN-VK
AB TEVA EQ 250MG BASE A060711 002
AB EQ 500MG BASE A060711 003
PENTAMIDINE ISETHIONATE
FOR SOLUTION;INHALATION
NEBUPENT
+ FRESENIUS KABI USA 300MG/VIAL N019887 001 Jun 15, 1989
INJECTABLE;INJECTION
PENTAM
AP + FRESENIUS KABI USA 300MG/VIAL N019264 001 Oct 16, 1984
PENTAMIDINE ISETHIONATE
AP WATSON LABS 300MG/VIAL A074303 001 Aug 17, 1995
PENTAZOCINE LACTATE
INJECTABLE;INJECTION
TALWIN
+ HOSPIRA EQ 30MG BASE/ML N016194 001
PENTOBARBITAL SODIUM
INJECTABLE;INJECTION
NEMBUTAL SODIUM
+ OAK PHARMS 50MG/ML A083246 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
PENTOSAN POLYSULFATE SODIUM
CAPSULE;ORAL
ELMIRON
+ JANSSEN PHARMS
PENTOSTATIN
INJECTABLE;INJECTION
NIPENT
AP + HOSPIRA INC
PENTOSTATIN
AP BEDFORD LABS
PENTOXIFYLLINE
TABLET, EXTENDED RELEASE;ORAL
PENTOXIFYLLINE
AB APOTEX
AB IMPAX LABS
AB MYLAN
AB PLIVA
AB VALEANT INTL
AB WATSON LABS
PENTOXIL
AB UPSHER SMITH
TRENTAL
AB + SANOFI AVENTIS US
PERAMPANEL
TABLET;ORAL
FYCOMPA
EISAI INC
+
PERFLUTREN
INJECTABLE;INTRAVENOUS
DEFINITY
+ LANTHEUS MEDCL
PERINDOPRIL ERBUMINE
TABLET;ORAL
ACEON
AB XOMA
AB
AB +
PERINDOPRIL ERBUMINE
AB APOTEX
AB
AB
AB AUROBINDO PHARMA
AB
AB
AB IVAX PHARMS
AB
AB
AB LUPIN LTD
AB
AB
AB ROXANE
AB
AB
PERMETHRIN
CREAM;TOPICAL
ELIMITE
AB + RENAISSANCE PHARMA
PERMETHRIN
AB ACTAVIS MID ATLANTIC
AB PERRIGO NEW YORK
100MG
10MG/VIAL
10MG/VIAL
400MG
400MG
400MG
400MG
400MG
400MG
400MG
400MG
2MG
4MG
6MG
8MG
10MG
12MG
6.52MG/ML
2MG
4MG
8MG
2MG
4MG
8MG
2MG
4MG
8MG
2MG
4MG
8MG
2MG
4MG
8MG
2MG
4MG
8MG
5%
5%
5%
3-281( of 362)
N020193 001 Sep 26, 1996
N020122 001 Oct 11, 1991
A077841 001 Aug 07, 2007
A075191 001 Jun 09, 1999
A075093 001 Aug 10, 1999
A074425 001 Jul 08, 1997
A074874 001 May 25, 1999
A075028 001 Jul 20, 1998
A075107 001 Sep 04, 1998
A074962 001 Mar 31, 1999
N018631 001 Aug 30, 1984
N202834 001 Oct 22, 2012
N202834 002 Oct 22, 2012
N202834 003 Oct 22, 2012
N202834 004 Oct 22, 2012
N202834 005 Oct 22, 2012
N202834 006 Oct 22, 2012
N021064 001 Jul 31, 2001
N020184 001 Dec 30, 1993
N020184 002 Dec 30, 1993
N020184 003 Dec 30, 1993
A090463 001 Aug 30, 2010
A090463 002 Aug 30, 2010
A090463 003 Aug 30, 2010
A079070 001 Nov 10, 2009
A079070 002 Nov 10, 2009
A079070 003 Nov 10, 2009
A078138 001 Nov 10, 2009
A078138 002 Nov 10, 2009
A078138 003 Nov 10, 2009
A078263 001 Jan 27, 2010
A078263 002 Jan 27, 2010
A078263 003 Jan 27, 2010
A090072 001 Nov 10, 2009
A090072 002 Nov 10, 2009
A090072 003 Nov 10, 2009
N019855 001 Aug 25, 1989
A074806 001 Jan 23, 1998
A076369 001 Apr 21, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-282( of 362)
PERPHENAZINE
TABLET;ORAL
PERPHENAZINE
AB SANDOZ 2MG A089683 001 Dec 08, 1988
AB 4MG A089684 001 Dec 08, 1988
AB 8MG A089685 001 Dec 08, 1988
AB + 16MG A089686 001 Dec 08, 1988
AB VINTAGE PHARMS 2MG A040226 001 Dec 31, 1998
AB 4MG A040226 002 Dec 31, 1998
AB 8MG A040226 003 Dec 31, 1998
AB 16MG A040226 004 Dec 31, 1998
PHENDIMETRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
BONTRIL
BC VALEANT 105MG A088021 001 Sep 21, 1982
PHENDIMETRAZINE TARTRATE
BC + SANDOZ 105MG N018074 001
TABLET;ORAL
BONTRIL PDM
AA + VALEANT 35MG A085272 001
PHENDIMETRAZINE TARTRATE
AA KVK TECH 35MG A091042 001 Aug 31, 2010
AA MIKAH PHARMA 35MG A040762 001 Jan 28, 2008
AA MIKART 35MG A089452 001 Oct 30, 1991
AA SANDOZ 35MG A085588 001
PHENELZINE SULFATE
TABLET;ORAL
NARDIL
AB + PARKE DAVIS EQ 15MG BASE N011909 002
PHENELZINE SULFATE
AB NOVEL LABS INC EQ 15MG BASE A200181 001 Dec 08, 2010
PHENOXYBENZAMINE HYDROCHLORIDE
CAPSULE;ORAL
DIBENZYLINE
AB + WELLSPRING PHARM 10MG N008708 001
PHENOXYBENZAMINE HYDROCHLORIDE
AB ROXANE 10MG A201050 001 Jul 16, 2012
PHENTERMINE HYDROCHLORIDE
CAPSULE;ORAL
ADIPEX-P
AA + TEVA 37.5MG A088023 001 Aug 02, 1983
PHENTERMINE HYDROCHLORIDE
AA BARR 15MG A090591 001 Mar 18, 2010
AA 30MG A090591 002 Mar 18, 2010
AA ELITE LABS 15MG A202248 001 Sep 28, 2012
AA 30MG A202248 002 Sep 28, 2012
AA KVK TECH 15MG A040886 002 Mar 31, 2008
AA 30MG A040875 001 Mar 21, 2008
AA 30MG A040886 001 Mar 31, 2008
AA 37.5MG A040887 001 Apr 24, 2008
AA LANNETT 15MG A087022 002 Jan 20, 2012
AA 30MG A087022 001 Feb 03, 1983
AA 30MG A091359 001 Jul 16, 2010
AA LANNETT HOLDINGS INC 37.5MG A201961 001 Jul 20, 2011
AA MUTUAL PHARM 30MG A040525 001 Oct 23, 2003
AA + SANDOZ 15MG A087190 002
AA + 30MG A086945 001 Jul 20, 1983
AA + 30MG A087190 001
TABLET;ORAL
ADIPEX-P
AA + TEVA 37.5MG A085128 001
PHENTERMINE HYDROCHLORIDE
AA BARR 37.5MG A090470 001 Aug 31, 2009
AA CARACO 37.5MG A040790 001 Aug 21, 2007
AA ELITE LABS 37.5MG A200272 001 Jan 31, 2011
AA KVK TECH 37.5MG A040876 001 Mar 31, 2008
AA LANNETT 37.5MG A040555 001 Apr 15, 2005
AA MIRROR PHARMS 37.5MG A091451 001 Sep 21, 2012
AA MUTUAL PHARM 37.5MG A040526 001 Oct 23, 2003
AA VINTAGE PHARMS 37.5MG A040377 001 Jan 04, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-283( of 362)
PHENTERMINE HYDROCHLORIDE
TABLET, ORALLY DISINTEGRATING;ORAL
SUPRENZA
CITIUS PHARMS 15MG N202088 001 Jun 13, 2011
30MG N202088 002 Jun 13, 2011
+ 37.5MG N202088 003 Mar 27, 2012
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
CAPSULE, EXTENDED RELEASE;ORAL
QSYMIA
VIVUS EQ 3.75MG BASE;23MG N022580 001 Jul 17, 2012
EQ 7.5MG BASE;46MG N022580 002 Jul 17, 2012
EQ 11.25MG BASE;69MG N022580 003 Jul 17, 2012
+ EQ 15MG BASE;92MG N022580 004 Jul 17, 2012
PHENTERMINE RESIN COMPLEX
CAPSULE, EXTENDED RELEASE;ORAL
PHENTERMINE RESIN COMPLEX
+ LANNETT HOLDINGS INC EQ 15MG BASE A040872 001 Jul 28, 2011
+ EQ 30MG BASE A040872 002 Jul 28, 2011
PHENTOLAMINE MESYLATE
INJECTABLE;INJECTION
PHENTOLAMINE MESYLATE
AP BEDFORD 5MG/VIAL A040235 001 Mar 11, 1998
REGITINE
AP + NOVARTIS 5MG/VIAL N008278 003
ORAVERSE
+ SEPTODONT HOLDING 0.4MG/1.7ML N022159 001 May 09, 2008
PHENYLEPHRINE HYDROCHLORIDE
SOLUTION;IV (INFUSION)
PHENYLEPHRINE HYDROCHLORIDE
+ WEST WARD PHARM CORP 10MG/ML (10MG/ML) N203826 001 Dec 20, 2012
SOLUTION/DROPS;OPHTHALMIC
PHENYLEPHRINE HYDROCHLORIDE
PARAGON BIOTECK 2.5% N203510 001 Mar 21, 2013
+ 10% N203510 002 Mar 21, 2013
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
AA VINTAGE 5MG/5ML;6.25MG/5ML A040654 001 Dec 07, 2006
PROMETH VC PLAIN
AA + ACTAVIS MID ATLANTIC 5MG/5ML;6.25MG/5ML A088761 001 Nov 08, 1984
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
AA AMNEAL PHARMS 5MG/5ML;6.25MG/5ML A040902 001 Aug 25, 2009
PHENYTOIN
SUSPENSION;ORAL
DILANTIN-125
AB + PARKE DAVIS
PHENYTOIN
125MG/5ML N008762 001
AB TARO
AB VISTAPHARM
AB
AB WOCKHARDT
TABLET, CHEWABLE;ORAL
DILANTIN
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
A040521 001 Mar 08, 2004
A040342 001 Jan 31, 2001
A040610 001 Aug 18, 2005
A040420 001 Apr 19, 2002
AB + PFIZER PHARMS 50MG A084427 001
PHENYTOIN
AB MYLAN PHARMS INC 50MG A200691 001 Dec 26, 2012
PHENYTOIN SODIUM
CAPSULE;ORAL
DILANTIN
AB + PARKE DAVIS 30MG EXTENDED A084349 001
AB + 100MG EXTENDED A084349 002
EXTENDED PHENYTOIN SODIUM
AB
AB
AB
AB
AB
AB
AB
AMNEAL PHARMS NY
MYLAN
SUN PHARM INDS
SUN PHARM INDS (IN)
TARO
WOCKHARDT
100MG EXTENDED
100MG EXTENDED
200MG EXTENDED
300MG EXTENDED
100MG EXTENDED
100MG EXTENDED
30MG EXTENDED
A040765 001 Nov 12, 2008
A040298 001 Dec 28, 1998
A040731 001 Jun 30, 2008
A040731 002 Jun 30, 2008
A040621 001 Dec 11, 2006
A040684 001 Sep 05, 2006
A040759 001 Dec 18, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-284( of 362)
PHENYTOIN SODIUM
CAPSULE;ORAL
EXTENDED PHENYTOIN SODIUM
AB WOCKHARDT USA 100MG EXTENDED A040732 001 Jan 30, 2008
PHENYTEK
AB MYLAN 200MG EXTENDED A040298 002 Dec 06, 2001
AB + 300MG EXTENDED A040298 003 Dec 06, 2001
INJECTABLE;INJECTION
PHENYTOIN SODIUM
AP + HIKMA MAPLE 50MG/ML A084307 001
AP HOSPIRA 50MG/ML A089521 001 Mar 17, 1987
AP LUITPOLD 50MG/ML A040781 001 Dec 04, 2007
AP X-GEN PHARMS 50MG/ML A040573 001 Sep 13, 2006
PHYTONADIONE
INJECTABLE;INJECTION
PHYTONADIONE
BP + INTL MEDICATION 1MG/0.5ML A083722 001
VITAMIN K1
BP + HOSPIRA 1MG/0.5ML A087954 001 Jul 25, 1983
+ 10MG/ML A087955 001 Jul 25, 1983
TABLET;ORAL
MEPHYTON
+ VALEANT PHARMS 5MG N010104 003
PILOCARPINE HYDROCHLORIDE
GEL;OPHTHALMIC
PILOPINE HS
+ ALCON 4% N018796 001 Oct 01, 1984
SOLUTION;OPHTHALMIC
ISOPTO CARPINE
ALCON RES 1% N200890 001 Jun 22, 2010
2% N200890 002 Jun 22, 2010
+ 4% N200890 003 Jun 22, 2010
TABLET;ORAL
PILOCARPINE HYDROCHLORIDE
AB COREPHARMA 5MG A076746 001 Nov 16, 2004
AB IMPAX LABS 5MG A077248 001 Mar 31, 2006
AB 7.5MG A077248 002 Mar 31, 2006
AB LANNETT 5MG A077220 001 Oct 14, 2005
AB 7.5MG A077220 002 May 06, 2009
AB ROXANE 5MG A076963 001 Dec 22, 2004
AB 7.5MG A076963 002 Feb 27, 2007
SALAGEN
AB EISAI INC 5MG N020237 001 Mar 22, 1994
AB + 7.5MG N020237 002 Apr 18, 2003
PIMECROLIMUS
CREAM;TOPICAL
ELIDEL
+ VALEANT BERMUDA 1% N021302 001 Dec 13, 2001
PIMOZIDE
TABLET;ORAL
ORAP
TEVA 1MG N017473 003 Aug 27, 1997
+ 2MG N017473 001 Jul 31, 1984
PINDOLOL
TABLET;ORAL
PINDOLOL
MYLAN PHARMS INC 5MG A074019 001 Sep 03, 1992
+ 10MG A074019 002 Sep 03, 1992
PIOGLITAZONE HYDROCHLORIDE
TABLET;ORAL
ACTOS
AB TAKEDA PHARMS USA EQ 15MG BASE N021073 001 Jul 15, 1999
AB EQ 30MG BASE N021073 002 Jul 15, 1999
AB + EQ 45MG BASE N021073 003 Jul 15, 1999
PIOGLITAZONE HYDROCHLORIDE
AB ACCORD HLTHCARE EQ 15MG BASE A200044 001 Feb 13, 2013
AB EQ 30MG BASE A200044 002 Feb 13, 2013
AB EQ 45MG BASE A200044 003 Feb 13, 2013
AB AUROBINDO PHARMA LTD EQ 15MG BASE A200268 001 Feb 13, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-285( of 362)
PIOGLITAZONE HYDROCHLORIDE
TABLET;ORAL
PIOGLITAZONE HYDROCHLORIDE
AB EQ 30MG BASE A200268 002 Feb 13, 2013
AB EQ 45MG BASE A200268 003 Feb 13, 2013
AB DR REDDYS LABS LTD EQ 15MG BASE A078383 001 Mar 12, 2013
AB EQ 30MG BASE A078383 002 Mar 12, 2013
AB EQ 45MG BASE A078383 003 Mar 12, 2013
AB MACLEODS PHARMS LTD EQ 15MG BASE A202467 001 Feb 06, 2013
AB EQ 30MG BASE A202467 002 Feb 06, 2013
AB EQ 45MG BASE A202467 003 Feb 06, 2013
AB MYLAN PHARMS INC EQ 15MG BASE A076801 001 Aug 17, 2012
AB EQ 30MG BASE A076801 002 Aug 17, 2012
AB EQ 45MG BASE A076801 003 Aug 17, 2012
AB SANDOZ EQ 15MG BASE A078670 001 Feb 13, 2013
AB EQ 30MG BASE A078670 002 Feb 13, 2013
AB EQ 45MG BASE A078670 003 Feb 13, 2013
AB SYNTHON PHARMS EQ 15MG BASE A078472 001 Feb 13, 2013
AB EQ 30MG BASE A078472 002 Feb 13, 2013
AB EQ 45MG BASE A078472 003 Feb 13, 2013
AB TEVA PHARMS USA EQ 15MG BASE A077210 001 Jan 10, 2014
AB EQ 30MG BASE A077210 002 Jan 10, 2014
AB EQ 45MG BASE A077210 003 Jan 10, 2014
AB TORRENT PHARMS LTD EQ 15MG BASE A091298 001 Feb 13, 2013
AB EQ 30MG BASE A091298 002 Feb 13, 2013
AB EQ 45MG BASE A091298 003 Feb 13, 2013
AB WATSON LABS EQ 15MG BASE A076798 001 Oct 26, 2012
AB EQ 30MG BASE A076798 002 Oct 26, 2012
AB EQ 45MG BASE A076798 003 Oct 26, 2012
AB ZYDUS PHARMS USA INC EQ 15MG BASE A202456 001 Feb 13, 2013
AB EQ 30MG BASE A202456 002 Feb 13, 2013
AB EQ 45MG BASE A202456 003 Feb 13, 2013
PIPERACILLIN SODIUM
INJECTABLE;INJECTION
PIPERACILLIN
+ IBI EQ 2GM BASE/VIAL A065114 001 Nov 14, 2003
+ EQ 3GM BASE/VIAL A065114 002 Nov 14, 2003
+ EQ 4GM BASE/VIAL A065114 003 Nov 14, 2003
+ EQ 40GM BASE/VIAL A065157 001 Jul 12, 2004
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
INJECTABLE;INJECTION
PIPERACILLIN AND TAZOBACTAM
AP AUROBINDO PHARMA LTD EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065498 001 May 23, 2011
AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065498 002 May 23, 2011
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065498 003 May 23, 2011
AP HOSPIRA INC EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065386 001 Sep 15, 2009
AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065386 002 Sep 15, 2009
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065386 003 Sep 15, 2009
AP EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL A065446 001 Sep 15, 2009
AP IBI EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065523 001 May 31, 2011
AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065523 002 May 31, 2011
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065523 003 May 31, 2011
AP EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL A090498 001 May 31, 2011
AP SANDOZ EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065362 001 Oct 21, 2010
AP EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065363 001 Oct 21, 2010
AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065362 002 Oct 21, 2010
AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065363 002 Oct 21, 2010
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065362 003 Oct 21, 2010
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065363 003 Oct 21, 2010
ZOSYN
AP + WYETH PHARMS INC EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL N050684 001 Oct 22, 1993
AP + EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL N050684 002 Oct 22, 1993
AP + EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL N050684 003 Oct 22, 1993
AP + EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL N050684 004 Oct 22, 1993
ZOSYN IN PLASTIC CONTAINER
+ WYETH PHARMS INC EQ 4GM BASE/100ML;EQ 500MG BASE/100ML N050750 003 Feb 24, 1998
+ EQ 40MG BASE/ML;EQ 5MG BASE/ML N050750 001 Feb 24, 1998
+ EQ 60MG BASE/ML;EQ 7.5MG BASE/ML N050750 002 Feb 24, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
PIRBUTEROL ACETATE
AEROSOL, METERED;INHALATION
MAXAIR
+ MEDICIS
PIROXICAM
CAPSULE;ORAL
FELDENE
AB PFIZER
AB +
PIROXICAM
AB MUTUAL PHARM
AB MYLAN
AB
AB NOSTRUM LABS
AB
AB TEVA
AB
AB WATSON LABS
AB
AB
AB
PITAVASTATIN CALCIUM
TABLET;ORAL
LIVALO
KOWA CO
+
PLERIXAFOR
SOLUTION;SUBCUTANEOUS
MOZOBIL
+ GENZYME
PODOFILOX
GEL;TOPICAL
CONDYLOX
+ WATSON PHARMS
SOLUTION;TOPICAL
CONDYLOX
AT + WATSON PHARMS
PODOFILOX
AT PADDOCK LLC
AT PRECISION DERMAT
POLIDOCANOL
SOLUTION;INTRAVENOUS
ASCLERA
CHEMISCH FBRK KRSSLR
+
VARITHENA
+ PROVENSIS
POLYETHYLENE GLYCOL 3350
FOR SOLUTION;ORAL
GLYCOLAX
AA KREMERS URBAN PHARMS
POLYETHYLENE GLYCOL 3350
AA BRECKENRIDGE PHARM
AA NEXGEN PHARMA INC
AA PADDOCK LLC
EQ 0.2MG BASE/INH
10MG
20MG
10MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
10MG
20MG
20MG
EQ 1MG BASE
EQ 2MG BASE
EQ 4MG BASE
24MG/1.2ML (20MG/ML)
0.5%
0.5%
0.5%
0.5%
10MG/2ML (5MG/ML)
20MG/2ML (10MG/ML)
180MG/18ML (10MG/ML)
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL
3-286( of 362)
N020014 001 Nov 30, 1992
N018147 002 Apr 06, 1982
N018147 003 Apr 06, 1982
A073535 001 Mar 12, 1993
A074102 001 Jul 31, 1992
A074102 002 Jul 31, 1992
A074116 001 Jun 15, 1993
A074118 001 Jun 15, 1993
A074131 001 Dec 11, 1992
A074131 002 Dec 11, 1992
A074287 001 May 16, 1996
A074460 001 Sep 29, 1995
A074287 002 May 16, 1996
A074460 002 Sep 29, 1995
N022363 001 Aug 03, 2009
N022363 002 Aug 03, 2009
N022363 003 Aug 03, 2009
N022311 001 Dec 15, 2008
N020529 001 Mar 13, 1997
N019795 001 Dec 13, 1990
A075600 001 Jan 29, 2002
A090184 001 Jul 21, 2010
N021201 001 Mar 30, 2010
N021201 002 Mar 30, 2010
N205098 001 Nov 25, 2013
A076652 001 Jul 02, 2004
A077736 001 May 26, 2006
A077706 001 Sep 27, 2006
A077893 001 May 26, 2006
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
FOR SOLUTION;ORAL
AA
LAX-LYTE WITH FLAVOR PACKS
PADDOCK LLC
AA
NULYTELY
+ BRAINTREE
AA
NULYTELY-FLAVORED
+ BRAINTREE
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
BOT
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
BOT
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
BOT
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE
AA MYLAN 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
BOT
A079232 001 Feb 25, 2010
N019797 001 Apr 22, 1991
N019797 002 Nov 18, 1994
A090409 001 Apr 02, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-287( of 362)
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
FOR SOLUTION;ORAL
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE
AA NOVEL LABS INC 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A090019 001 May 27, 2009
BOT
TRILYTE
AA MEDA PHARMS 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A076491 001 Feb 05, 2004
BOT
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
ANHYDROUS
FOR SOLUTION;ORAL
GOLYTELY
AA + BRAINTREE 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ N019011 001 Jul 13, 1984
BOT;22.74GM/BOT
PEG 3350 AND ELECTROLYTES
AA MYLAN 236GM;2.97GM;6.74GM;5.86GM;22.74GM A090928 001 Jan 28, 2010
AA NOVEL LABS INC 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A090231 001 Jun 01, 2009
BOT;22.74GM/BOT
AA 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ A090186 001 Jun 01, 2009
BOT;22.72GM/BOT
COLYTE
MEDA PHARMS 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G N018983 010 Jan 31, 1989
M/BOT;21.5GM/BOT
COLYTE WITH FLAVOR PACKS
MEDA PHARMS 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ N018983 012 Oct 08, 1998
BOT;22.72GM/BOT
GOLYTELY
+ BRAINTREE 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC N019011 002 Jun 02, 1992
KET;5.53GM/PACKET;21.5GM/PACKET
POLYMYXIN B SULFATE
INJECTABLE;INJECTION
POLYMYCIN B SULFATE
AP SAGENT STRIDES EQ 500,000 UNITS BASE/VIAL A090110 001 Jun 29, 2011
POLYMYXIN B SULFATE
AP + BEDFORD EQ 500,000 U BASE/VIAL A060716 001
AP FRESENIUS KABI USA EQ 500,000 U BASE/VIAL A065372 001 Jan 10, 2008
AP X GEN PHARMS EQ 500,000 U BASE/VIAL A063000 001 Sep 30, 1994
AP XELLIA PHARMS APS EQ 500,000 U BASE/VIAL A202766 001 Jan 15, 2014
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
SOLUTION/DROPS;OPHTHALMIC
POLYTRIM
AT + ALLERGAN 10,000 UNITS/ML;EQ 1MG BASE/ML N050567 001 Oct 20, 1988
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
AT AKORN INC 10,000 UNITS/ML;EQ 1MG BASE/ML A065006 001 Dec 17, 1998
AT BAUSCH AND LOMB 10,000 UNITS/ML;EQ 1MG BASE/ML A064120 001 Feb 14, 1997
AT FALCON PHARMS 10,000 UNITS/ML;EQ 1MG BASE/ML A064211 001 Apr 13, 1998
POMALIDOMIDE
CAPSULE;ORAL
POMALYST
CELGENE 1MG N204026 001 Feb 08, 2013
2MG N204026 002 Feb 08, 2013
3MG N204026 003 Feb 08, 2013
+ 4MG N204026 004 Feb 08, 2013
PONATINIB HYDROCHLORIDE
TABLET;ORAL
ICLUSIG
ARIAD EQ 15MG BASE N203469 001 Dec 14, 2012
+ EQ 45MG BASE N203469 002 Dec 14, 2012
PORACTANT ALFA
SUSPENSION;INTRATRACHEAL
CUROSURF
+ CORNERSTONE THERAP 80MG/ML N020744 001 Nov 18, 1999
PORFIMER SODIUM
INJECTABLE;INJECTION
PHOTOFRIN
PINNACLE BIOLGS 75MG/VIAL N020451 001 Dec 27, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-288( of 362)
POSACONAZOLE
SUSPENSION;ORAL
NOXAFIL
+ SCHERING 40MG/ML N022003 001 Sep 15, 2006
TABLET, DELAYED RELEASE;ORAL
NOXAFIL
+ MERCK SHARP DOHME 100MG N205053 001 Nov 25, 2013
POTASSIUM ACETATE
INJECTABLE;INJECTION
POTASSIUM ACETATE IN PLASTIC CONTAINER
+ HOSPIRA 2MEQ/ML N018896 001 Jul 20, 1984
POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
MICRO-K
AB NESHER PHARMS 8MEQ N018238 001
MICRO-K 10
AB NESHER PHARMS 10MEQ N018238 002 May 14, 1984
POTASSIUM CHLORIDE
AB AMNEAL PHARMS 10MEQ A202128 001 Feb 22, 2013
AB ANCHEN PHARMS 8MEQ A202886 001 Dec 26, 2013
AB 10MEQ A202886 002 Dec 26, 2013
AB PADDOCK LLC 8MEQ A200185 001 May 18, 2011
AB 10MEQ A200185 002 May 18, 2011
AB WATSON LABS FLORIDA 8MEQ A077419 001 Jun 02, 2008
AB + 10MEQ A077419 002 Jun 02, 2008
INJECTABLE;INJECTION
POTASSIUM CHLORIDE
AP B BRAUN 2MEQ/ML A085870 001
AP BAXTER HLTHCARE 2MEQ/ML A085499 001
AP FRESENIUS KABI USA 2MEQ/ML A080225 001
AP + HOSPIRA 2MEQ/ML A080205 001
AP INTL MEDICATION 2MEQ/ML A083163 001
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 14.9MG/ML N019904 001 Dec 26, 1989
AP + 746MG/100ML N019904 005 Dec 17, 1990
AP HOSPIRA 14.9MG/ML N020161 005 Nov 30, 1992
AP 745MG/100ML N020161 001 Nov 30, 1992
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 1.49GM/100ML N019904 006 Dec 17, 1990
AP + 29.8MG/ML N019904 002 Dec 26, 1989
AP HOSPIRA 1.49GM/100ML N020161 002 Nov 30, 1992
AP + 29.8MG/ML N020161 006 Aug 11, 1998
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 2.24GM/100ML N019904 003 Dec 26, 1989
AP + HOSPIRA 2.24GM/100ML N020161 003 Aug 11, 1998
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 2.98GM/100ML N019904 004 Dec 26, 1989
AP + HOSPIRA 2.98GM/100ML N020161 004 Aug 11, 1998
POTASSIUM CHLORIDE IN PLASTIC CONTAINER
AP FRESENIUS KABI USA 2MEQ/ML A088901 001 Jan 25, 1985
AP 2MEQ/ML A088908 001 Jan 25, 1985
POTASSIUM CHLORIDE
+ FRESENIUS KABI USA 3MEQ/ML A080225 003
TABLET, EXTENDED RELEASE;ORAL
KLOR-CON M10
AB UPSHER SMITH LABS 10MEQ A074726 002 Aug 09, 2000
KLOR-CON M20
AB + UPSHER SMITH LABS 20MEQ A074726 001 Nov 20, 1998
POTASSIUM CHLORIDE
AB EURAND 20MEQ A076368 001 Aug 18, 2004
AB WATSON LABS FLORIDA 10MEQ A075604 001 Apr 10, 2002
AB 20MEQ A075604 002 Apr 10, 2002
K-TAB
BC ABBVIE 20MEQ N018279 003 Nov 25, 2013
KLOR-CON
BC + UPSHER-SMITH LABS 10MEQ N019123 002 Apr 17, 1986
8MEQ N019123 001 Apr 17, 1986
KLOR-CON M15
UPSHER SMITH LABS 15MEQ A074726 003 Jun 06, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-289( of 362)
POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP HOSPIRA 149MG/100ML;450MG/100ML A078446 001 Sep 10, 2008
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 150MG/100ML;450MG/100ML N017648 005 Nov 26, 2002
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 150MG/100ML;900MG/100ML N019708 004 Sep 29, 1989
AP BAXTER HLTHCARE 150MG/100ML;900MG/100ML N017648 001
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 300MG/100ML;900MG/100ML N017648 002
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP HOSPIRA 149MG/100ML;900MG/100ML N019686 001 Oct 17, 1988
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP HOSPIRA 298MG/100ML;900MG/100ML N019686 002 Oct 17, 1988
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
BAXTER HLTHCARE 224MG/100ML;900MG/100ML N017648 003
POTASSIUM CITRATE
TABLET, EXTENDED RELEASE;ORAL
POTASSIUM CITRATE
AB COREPHARMA 5MEQ A077440 001 Jun 09, 2006
AB 10MEQ A077440 002 Jun 09, 2006
UROCIT-K
AB MISSION PHARMA 5MEQ N019071 001 Aug 30, 1985
AB 10MEQ N019071 002 Aug 31, 1992
+ 15MEQ N019071 003 Dec 30, 2009
POVIDONE-IODINE
SOLUTION/DROPS;OPHTHALMIC
BETADINE
+ ALCON PHARMS LTD 5% N018634 001 Dec 17, 1986
PRALATREXATE
SOLUTION;INTRAVENOUS
FOLOTYN
ALLOS 20MG/ML (20MG/ML) N022468 001 Sep 24, 2009
+ 40MG/2ML (20MG/ML) N022468 002 Sep 24, 2009
PRALIDOXIME CHLORIDE
INJECTABLE;INJECTION
PRALIDOXIME CHLORIDE
+ MERIDIAN MEDCL TECHN 300MG/ML N018986 001 Apr 26, 1983
PROTOPAM CHLORIDE
+ BAXTER HLTHCARE CORP 1GM/VIAL N014134 001
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL
MIRAPEX
AB BOEHRINGER INGELHEIM 0.125MG N020667 001 Jul 01, 1997
AB + 0.25MG N020667 002 Jul 01, 1997
AB 0.5MG N020667 006 Feb 12, 1998
AB 0.75MG N020667 007 Jul 30, 2007
AB 1MG N020667 003 Jul 01, 1997
AB 1.5MG N020667 005 Jul 01, 1997
PRAMIPEXOLE DIHYDROCHLORIDE
AB ACTAVIS GRP PTC 0.125MG A091254 001 Nov 30, 2010
AB 0.25MG A091254 002 Nov 30, 2010
AB 0.5MG A091254 003 Nov 30, 2010
AB 0.75MG A091254 004 Nov 30, 2010
AB 1MG A091254 005 Nov 30, 2010
AB 1.5MG A091254 006 Nov 30, 2010
AB ALEMBIC LTD 0.125MG A078894 001 Oct 08, 2010
AB 0.25MG A078894 002 Oct 08, 2010
AB 0.5MG A078894 003 Oct 08, 2010
AB 1MG A078894 004 Oct 08, 2010
AB 1.5MG A078894 005 Oct 08, 2010
AB APOTEX INC 0.125MG A090151 001 Apr 30, 2012
AB 0.25MG A090151 002 Apr 30, 2012
AB 0.5MG A090151 003 Apr 30, 2012
AB 0.75MG A090151 006 Apr 30, 2012
AB 1MG A090151 004 Apr 30, 2012
AB 1.5MG A090151 005 Apr 30, 2012
AB AUROBINDO PHARMA LTD 0.125MG A202633 001 Oct 26, 2012
AB 0.25MG A202633 002 Oct 26, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-290( of 362)
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL
PRAMIPEXOLE DIHYDROCHLORIDE
AB 0.5MG A202633 003 Oct 26, 2012
AB 0.75MG A202633 004 Oct 26, 2012
AB 1MG A202633 005 Oct 26, 2012
AB 1.5MG A202633 006 Oct 26, 2012
AB BARR 0.125MG A077724 001 Feb 19, 2008
AB 0.25MG A077724 002 Feb 19, 2008
AB 0.5MG A077724 003 Feb 19, 2008
AB 1MG A077724 004 Feb 19, 2008
AB 1.5MG A077724 005 Feb 19, 2008
AB BRECKENRIDGE PHARM 0.125MG A091450 001 Oct 08, 2010
AB 0.25MG A091450 002 Oct 08, 2010
AB 0.5MG A091450 003 Oct 08, 2010
AB 1MG A091450 004 Oct 08, 2010
AB 1.5MG A091450 005 Oct 08, 2010
AB GLENMARK GENERICS 0.125MG A090781 001 Oct 08, 2010
AB 0.25MG A090781 002 Oct 08, 2010
AB 0.5MG A090781 003 Oct 08, 2010
AB 1MG A090781 004 Oct 08, 2010
AB 1.5MG A090781 005 Oct 08, 2010
AB MACLEODS PHARMS LTD 0.125MG A202164 001 Sep 20, 2012
AB 0.25MG A202164 002 Sep 20, 2012
AB 0.5MG A202164 003 Sep 20, 2012
AB 1MG A202164 004 Sep 20, 2012
AB 1.5MG A202164 005 Sep 20, 2012
AB MYLAN 0.125MG A077854 001 Oct 08, 2010
AB 0.25MG A077854 002 Oct 08, 2010
AB 0.5MG A077854 003 Oct 08, 2010
AB 0.75MG A090764 001 Apr 09, 2010
AB 1MG A077854 004 Oct 08, 2010
AB 1.5MG A077854 005 Oct 08, 2010
AB SANDOZ 0.125MG A090190 001 Jul 06, 2010
AB 0.25MG A090190 002 Jul 06, 2010
AB 0.5MG A090190 003 Jul 06, 2010
AB 0.75MG A090190 006 Oct 08, 2010
AB 1MG A090190 004 Jul 06, 2010
AB 1.5MG A090190 005 Jul 06, 2010
AB SUN PHARM INDS INC 0.125MG A091683 001 Mar 27, 2013
AB 0.25MG A091683 002 Mar 27, 2013
AB 0.5MG A091683 003 Mar 27, 2013
AB 0.75MG A091683 004 Mar 27, 2013
AB 1MG A091683 005 Mar 27, 2013
AB 1.5MG A091683 006 Mar 27, 2013
AB TEVA PHARMS 0.125MG A090241 001 Oct 08, 2010
AB 0.25MG A090241 002 Oct 08, 2010
AB 0.5MG A090241 003 Oct 08, 2010
AB 0.75MG A090241 004 Oct 08, 2010
AB 1MG A090241 005 Oct 08, 2010
AB 1.5MG A090241 006 Oct 08, 2010
AB TORRENT PHARMS 0.125MG A090865 001 Oct 08, 2010
AB 0.25MG A090865 002 Oct 08, 2010
AB 0.5MG A090865 003 Oct 08, 2010
AB 0.75MG A090865 004 Oct 08, 2010
AB 1MG A090865 005 Oct 08, 2010
AB 1.5MG A090865 006 Oct 08, 2010
AB WATSON LABS 0.125MG A078551 001 Oct 08, 2010
AB 0.25MG A078551 002 Oct 08, 2010
AB 0.5MG A078551 003 Oct 08, 2010
AB 1MG A078551 004 Oct 08, 2010
AB 1.5MG A078551 005 Oct 08, 2010
AB ZYDUS PHARMS USA INC 0.125MG A078920 001 Jul 06, 2010
AB 0.25MG A078920 002 Jul 06, 2010
AB 0.5MG A078920 003 Jul 06, 2010
AB 1MG A078920 004 Jul 06, 2010
AB 1.5MG A078920 005 Jul 06, 2010
TABLET, EXTENDED RELEASE;ORAL
MIRAPEX ER
+ BOEHRINGER INGELHEIM 0.375MG
0.75MG
1.5MG
N022421 001
N022421 002
N022421 003
Feb 19, 2010
Feb 19, 2010
Feb 19, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
MIRAPEX ER
PRAMLINTIDE ACETATE
INJECTABLE;SUBCUTANEOUS
SYMLIN
AMYLIN PHARMS LLC
+
PRASUGREL HYDROCHLORIDE
TABLET;ORAL
EFFIENT
ELI LILLY AND CO
+
PRAVASTATIN SODIUM
TABLET;ORAL
PRAVACHOL
AB
AB
BRISTOL MYERS SQUIBB
AB
AB +
PRAVASTATIN SODIUM
AB APOTEX
AB
AB
AB
AB CIPLA LTD
AB
AB
AB DR REDDYS LABS INC
AB
AB
AB
AB GLENMARK GENERICS
AB
AB
AB
AB LUPIN PHARMS
AB
AB
AB
AB MYLAN
AB
AB
AB
AB MYLAN PHARMS INC
AB
AB
AB
AB TEVA
AB
AB
AB TEVA PHARMS
AB WATSON LABS
AB
AB
AB
AB ZYDUS PHARMS USA
AB
AB
AB
2.25MG
3MG
3.75MG
4.5MG
EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)
EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)
EQ 5MG BASE
EQ 10MG BASE
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
3-291( of 362)
N022421 006 Jun 17, 2011
N022421 004 Feb 19, 2010
N022421 007 Jun 17, 2011
N022421 005 Feb 19, 2010
N021332 002 Sep 25, 2007
N021332 003 Sep 25, 2007
N022307 001 Jul 10, 2009
N022307 002 Jul 10, 2009
N019898 002 Oct 31, 1991
N019898 003 Oct 31, 1991
N019898 004 Mar 22, 1993
N019898 008 Dec 18, 2001
A076341 001 Oct 23, 2006
A076341 002 Oct 23, 2006
A076341 003 Oct 23, 2006
A076341 004 Dec 28, 2007
A077904 001 Oct 23, 2006
A077904 002 Oct 23, 2006
A077904 003 Oct 23, 2006
A076714 001 Oct 23, 2006
A076714 002 Oct 23, 2006
A076714 003 Oct 23, 2006
A076714 004 Dec 28, 2007
A077987 001 May 11, 2007
A077987 002 May 11, 2007
A077987 003 May 11, 2007
A077987 004 Dec 28, 2007
A077917 001 Jan 08, 2008
A077917 002 Jan 08, 2008
A077917 003 Jan 08, 2008
A077917 004 Jan 08, 2008
A077013 001 Oct 23, 2006
A077013 002 Oct 23, 2006
A077013 003 Oct 23, 2006
A077013 004 Dec 28, 2007
A079187 001 May 27, 2010
A079187 002 May 27, 2010
A079187 003 May 27, 2010
A079187 004 May 27, 2010
A076056 001 Apr 24, 2006
A076056 002 Apr 24, 2006
A076056 003 Apr 24, 2006
A077793 001 Jan 15, 2008
A076939 004 Oct 23, 2006
A076939 003 Oct 23, 2006
A076939 002 Oct 23, 2006
A076939 001 Dec 28, 2007
A077751 001 Apr 30, 2008
A077751 002 Apr 30, 2008
A077751 003 Apr 30, 2008
A077751 004 Apr 30, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-292( of 362)
PRAZIQUANTEL
TABLET;ORAL
BILTRICIDE
+ BAYER HLTHCARE 600MG N018714 001 Dec 29, 1982
PRAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
MINIPRESS
AB PFIZER EQ 1MG BASE N017442 002
AB + EQ 2MG BASE N017442 003
AB EQ 5MG BASE N017442 001
PRAZOSIN HYDROCHLORIDE
AB IVAX SUB TEVA PHARMS EQ 1MG BASE A071994 001 Sep 12, 1988
AB MYLAN EQ 1MG BASE A072575 003 May 16, 1989
AB EQ 2MG BASE A072575 002 May 16, 1989
AB EQ 5MG BASE A072575 001 May 16, 1989
AB TEVA PHARMS EQ 2MG BASE A071995 001 Sep 12, 1988
AB EQ 5MG BASE A071745 001 Sep 12, 1988
PREDNICARBATE
CREAM;TOPICAL
DERMATOP E EMOLLIENT
AB + VALEANT BERMUDA 0.1% N020279 001 Oct 29, 1993
PREDNICARBATE
AB FOUGERA PHARMS 0.1% A077287 001 Sep 19, 2006
OINTMENT;TOPICAL
DERMATOP
AB + VALEANT BERMUDA 0.1% N019568 001 Sep 23, 1991
PREDNICARBATE
AB FOUGERA PHARMS 0.1% A077236 001 Mar 09, 2007
PREDNISOLONE
SYRUP;ORAL
PREDNISOLONE
AA ALPHARMA 15MG/5ML A040323 001 May 13, 1999
AA + HI TECH PHARMA CO 15MG/5ML A040401 001 Feb 27, 2003
AA PHARM ASSOC 15MG/5ML A040399 001 Mar 05, 2003
AA VINTAGE 15MG/5ML A040775 001 Sep 21, 2007
AA WOCKHARDT 15MG/5ML A040313 001 Sep 10, 2003
PRELONE
AA TEVA 15MG/5ML A089081 001 Feb 04, 1986
TABLET;ORAL
PREDNISOLONE
+ WATSON LABS 5MG A080354 001
PREDNISOLONE ACETATE
SUSPENSION;ORAL
FLO-PRED
+ TARO EQ 15MG BASE/5ML N022067 002 Jan 17, 2008
SUSPENSION/DROPS;OPHTHALMIC
OMNIPRED
AB ALCON 1% N017469 001
PRED FORTE
AB + ALLERGAN 1% N017011 001
PRED MILD
+ ALLERGAN 0.12% N017100 001
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
OINTMENT;OPHTHALMIC
BLEPHAMIDE S.O.P.
+ ALLERGAN 0.2%;10% A087748 001 Dec 03, 1986
SUSPENSION;OPHTHALMIC
BLEPHAMIDE
+ ALLERGAN 0.2%;10% N012813 002
PREDNISOLONE SODIUM PHOSPHATE
SOLUTION;ORAL
ORAPRED
AA + CONCORDIA PHARMS INC EQ 15MG BASE/5ML A075117 001 Dec 14, 2000
PEDIAPRED
AA + SETON PHARM EQ 5MG BASE/5ML N019157 001 May 28, 1986
PREDNISOLONE SODIUM PHOSPHATE
AA AMNEAL PHARMS EQ 15MG BASE/5ML A078345 001 Mar 10, 2009
AA HI TECH PHARMA EQ 5MG BASE/5ML A075183 001 Mar 26, 2003
AA PADDOCK LLC EQ 5MG BASE/5ML A075988 001 May 25, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-293( of 362)
PREDNISOLONE SODIUM PHOSPHATE
SOLUTION;ORAL
PREDNISOLONE SODIUM PHOSPHATE
AA PHARM ASSOC EQ 15MG BASE/5ML A076913 001 Apr 25, 2005
AA VINTAGE EQ 15MG BASE/5ML A079010 001 May 26, 2009
AA WOCKHARDT EQ 5MG BASE/5ML A075099 001 Jun 28, 2002
AA EQ 15MG BASE/5ML A076895 001 Oct 04, 2004
+ MISSION PHARMA EQ 25MG BASE/5ML A091396 001 Sep 13, 2010
+ PHARM ASSOC EQ 10MG BASE/5ML A078465 001 Mar 07, 2008
+ EQ 20MG BASE/5ML A078988 001 Jun 09, 2008
SOLUTION/DROPS;OPHTHALMIC
PREDNISOLONE SODIUM PHOSPHATE
+ BAUSCH AND LOMB EQ 0.9% PHOSPHATE A040070 001 Jul 29, 1994
TABLET, ORALLY DISINTEGRATING;ORAL
ORAPRED ODT
AB CONCORDIA PHARMS INC EQ 10MG BASE N021959 001 Jun 01, 2006
AB EQ 15MG BASE N021959 002 Jun 01, 2006
AB + EQ 30MG BASE N021959 003 Jun 01, 2006
PREDNISOLONE SODIUM PHOSPHATE
AB MYLAN PHARMS INC EQ 10MG BASE A202179 001 Apr 10, 2013
AB EQ 15MG BASE A202179 002 Apr 10, 2013
AB EQ 30MG BASE A202179 003 Apr 10, 2013
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
SOLUTION/DROPS;OPHTHALMIC
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE
AT
AT
ALCON PHARMS LTD
BAUSCH AND LOMB
VASOCIDIN
EQ 0.23% PHOSPHATE;10%
EQ 0.23% PHOSPHATE;10%
A073630 001 May 27, 1993
A074449 001 Dec 29, 1995
AT + NOVARTIS EQ 0.23% PHOSPHATE;10% N018988 001 Aug 26, 1988
PREDNISONE
SOLUTION;ORAL
PREDNISONE
ROXANE +
PREDNISONE INTENSOL
5MG/5ML A088703 001 Nov 08, 1984
ROXANE +
TABLET;ORAL
PREDNISONE
5MG/ML A088810 001 Feb 20, 1985
AB CONTRACT PHARMACAL 5MG A080209 001
AB
AB
AB
HIKMA PHARMS 1MG
2.5MG
5MG
A040890 001 Nov 01, 2010
A040538 001 Jan 08, 2004
A080292 001
AB
AB
10MG
20MG
A088832 001 Dec 04, 1985
A083677 001
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
+
+
+
JUBILANT CADISTA
MUTUAL PHARM
ROXANE
50MG
1MG
5MG
10MG
20MG
5MG
10MG
20MG
1MG
2.5MG
5MG
A088465 001 Jun 01, 1984
A040611 001 Jun 06, 2005
A040362 002 Aug 29, 2001
A040362 001 Aug 29, 2001
A040362 003 Jun 29, 2005
A089245 001 Dec 04, 1985
A089246 001 Dec 04, 1985
A089247 001 Dec 04, 1985
A087800 001 Apr 22, 1982
A087801 001 Apr 22, 1982
A080352 001
AB + 10MG A084122 001
AB + 20MG A087342 001
AB + 50MG A084283 001
AB
AB
AB
AB
AB
AB
VINTAGE PHARMS
WATSON LABS
1MG
2.5MG
5MG
10MG
20MG
5MG
A040584 001 Dec 21, 2004
A040581 001 Dec 21, 2004
A040256 001 Jul 12, 2002
A040256 002 Jul 12, 2002
A040392 001 Feb 12, 2003
A080356 001
AB 10MG A085162 001
AB 20MG A085161 001
TABLET, DELAYED RELEASE;ORAL
RAYOS
+
HORIZON PHARMA 1MG
2MG
5MG
N202020 001
N202020 002
N202020 003
Jul 26, 2012
Jul 26, 2012
Jul 26, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
PREGABALIN
CAPSULE;ORAL
LYRICA
AB PF PRISM 25MG
AB 50MG
AB 75MG
AB 100MG
AB 150MG
AB 200MG
AB 225MG
AB + 300MG
PREGABALIN
AB LUPIN LTD 25MG
AB 50MG
AB 75MG
AB 100MG
AB 150MG
AB 200MG
AB 225MG
AB 300MG
AB TEVA PHARMS 25MG
AB 50MG
AB 75MG
AB 100MG
AB 150MG
AB 200MG
AB 225MG
AB 300MG
AB WATSON LABS INC 25MG
AB 50MG
AB 75MG
AB 100MG
AB 150MG
AB 200MG
AB 225MG
AB 300MG
SOLUTION;ORAL
LYRICA
+ PF PRISM 20MG/ML
PRILOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
PRILOCAINE HYDROCHLORIDE
+ SEPTODONT INC 4%
PRIMAQUINE PHOSPHATE
TABLET;ORAL
PRIMAQUINE
+ SANOFI AVENTIS US EQ 15MG BASE
PRIMIDONE
TABLET;ORAL
MYSOLINE
AB + VALEANT 50MG
AB 250MG
PRIMIDONE
AB AMNEAL PHARM 50MG
AB 250MG
AB IMPAX LABS 50MG
AB 250MG
AB LANNETT 50MG
AB 250MG
AB MUTUAL PHARM 50MG
AB 250MG
AB VINTAGE PHARMS 50MG
AB 250MG
AB WATSON LABS 250MG
AB WEST WARD 250MG
3-294( of 362)
N021446 001 Dec 30, 2004
N021446 002 Dec 30, 2004
N021446 003 Dec 30, 2004
N021446 004 Dec 30, 2004
N021446 005 Dec 30, 2004
N021446 006 Dec 30, 2004
N021446 007 Dec 30, 2004
N021446 008 Dec 30, 2004
A091040 001 Jul 03, 2012
A091040 002 Jul 03, 2012
A091040 003 Jul 03, 2012
A091040 004 Jul 03, 2012
A091040 005 Jul 03, 2012
A091040 006 Jul 03, 2012
A091040 007 Jul 03, 2012
A091040 008 Jul 03, 2012
A091219 001 Jul 03, 2012
A091219 002 Jul 03, 2012
A091224 001 Jul 03, 2012
A091224 002 Jul 03, 2012
A091224 003 Jul 03, 2012
A091224 004 Jul 03, 2012
A091224 005 Jul 03, 2012
A091224 006 Jul 03, 2012
A091221 001 Jul 03, 2012
A091221 002 Jul 03, 2012
A091221 003 Jul 03, 2012
A091221 004 Jul 03, 2012
A091221 005 Jul 03, 2012
A091221 006 Jul 03, 2012
A091221 007 Jul 03, 2012
A091221 008 Jul 03, 2012
N022488 001 Jan 04, 2010
A079235 001 Sep 29, 2010
N008316 001
N009170 003
N009170 002
A040866 001 Apr 23, 2008
A040866 002 Apr 23, 2008
A040717 001 Feb 12, 2008
A040717 002 Feb 12, 2008
A084903 002 May 24, 2001
A084903 001
A040626 001 Sep 29, 2005
A040626 002 Sep 29, 2005
A040586 001 Feb 24, 2005
A040586 002 Feb 24, 2005
A083551 001
A040667 002 Jul 27, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-295( of 362)
PROBENECID
TABLET;ORAL
PROBALAN
AB LANNETT 500MG A080966 001
PROBENECID
AB + MYLAN 500MG A084211 002
AB WATSON LABS 500MG A084442 004 Mar 29, 1983
PROCAINAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
PROCAINAMIDE HYDROCHLORIDE
AP + HOSPIRA 100MG/ML A089069 001 Feb 12, 1986
AP + 500MG/ML A089070 001 Feb 12, 1986
AP INTL MEDICATION 100MG/ML A088636 001 Jul 31, 1984
AP 500MG/ML A088637 001 Jul 31, 1984
PROCARBAZINE HYDROCHLORIDE
CAPSULE;ORAL
MATULANE
+ SIGMA TAU EQ 50MG BASE N016785 001
PROCHLORPERAZINE
SUPPOSITORY;RECTAL
COMPRO
AB PADDOCK LLC 25MG A040246 001 Jun 28, 2000
PROCHLORPERAZINE
AB + G AND W LABS 25MG A040058 001 Nov 24, 1993
PROCHLORPERAZINE EDISYLATE
INJECTABLE;INJECTION
PROCHLORPERAZINE EDISYLATE
AP BEDFORD EQ 5MG BASE/ML A040540 001 May 28, 2004
AP EMCURE PHARMS LTD EQ 5MG BASE/ML A204147 001 Oct 15, 2013
AP + HIKMA MAPLE EQ 5MG BASE/ML A089903 001 Aug 29, 1989
PROCHLORPERAZINE MALEATE
TABLET;ORAL
PROCHLORPERAZINE MALEATE
AB MYLAN EQ 5MG BASE A040185 002 Oct 28, 1996
AB EQ 10MG BASE A040185 001 Oct 28, 1996
AB SANDOZ EQ 5MG BASE A040101 001 Jul 19, 1996
AB + EQ 10MG BASE A040101 002 Jul 19, 1996
AB TEVA PHARMS EQ 5MG BASE A040120 001 Jul 11, 1996
AB EQ 10MG BASE A040120 002 Jul 11, 1996
PROCOMP
AB JUBILANT CADISTA EQ 5MG BASE A040268 001 Feb 27, 1998
AB EQ 10MG BASE A040268 002 Feb 27, 1998
PROGESTERONE
CAPSULE;ORAL
PROGESTERONE
AB BANNER PHARMACAPS 100MG A200900 001 Aug 16, 2013
AB 200MG A200900 002 Aug 16, 2013
AB SOFGEN PHARMS 100MG A200456 001 Sep 28, 2012
AB 200MG A200456 002 Sep 28, 2012
AB TEVA PHARMS 100MG A202121 001 Feb 29, 2012
AB 200MG A202121 002 Feb 29, 2012
PROMETRIUM
AB ABBVIE INC 100MG N019781 001 May 14, 1998
AB + 200MG N019781 002 Oct 15, 1999
GEL;VAGINAL
CRINONE
WATSON LABS 4% N020701 001 Jul 31, 1997
+ 8% N020701 002 Jul 31, 1997
INJECTABLE;INJECTION
PROGESTERONE
AO FRESENIUS KABI USA 50MG/ML A075906 001 Apr 25, 2001
AO HIKMA FARMACEUTICA 50MG/ML A091033 001 Oct 28, 2010
AO LUITPOLD 50MG/ML A090845 001 Jun 22, 2009
AO + WATSON LABS (UTAH) 50MG/ML N017362 002
INSERT;VAGINAL
ENDOMETRIN
+ FERRING 100MG N022057 001 Jun 21, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
PROMETHAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
PROMETHAZINE HYDROCHLORIDE
AP HIKMA MAPLE
AP
AP HOSPIRA
AP LUITPOLD
AP + TEVA PHARMS USA
AP +
AP WOCKHARDT
AP
AP X-GEN PHARMS
AP
SUPPOSITORY;RECTAL
PROMETHAZINE HYDROCHLORIDE
AB G AND W LABS
AB +
AB PERRIGO NEW YORK
AB
AB TARO
AB
AB WATSON LABS INC
AB
PROMETHEGAN
+ G AND W LABS
SYRUP;ORAL
PROMETHAZINE HYDROCHLORIDE
AA AMNEAL PHARMS
AA CARACO
AA HI TECH PHARMA
AA TARO
AA TRIS PHARMA INC
AA VINTAGE
PROMETHAZINE PLAIN
AA + WOCKHARDT
TABLET;ORAL
PROMETHAZINE HYDROCHLORIDE
AB AMNEAL PHARMS NY
AB
AB
AB CARACO
AB
AB
AB EMCURE PHARMS USA
AB
AB
AB IMPAX LABS
AB
AB
AB KVK TECH
AB
AB
AB MYLAN
AB
AB
AB SANDOZ
AB +
AB VINTAGE PHARMS
AB
AB
AB WATSON LABS
AB
AB ZYDUS PHARMS USA
AB
AB
PROPAFENONE HYDROCHLORIDE
25MG/ML
50MG/ML
25MG/ML
25MG/ML
25MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG/ML
50MG/ML
12.5MG
25MG
12.5MG
25MG
12.5MG
25MG
12.5MG
25MG
50MG
6.25MG/5ML
6.25MG/5ML
6.25MG/5ML
6.25MG/5ML
6.25MG/5ML
6.25MG/5ML
6.25MG/5ML
12.5MG
25MG
50MG
12.5MG
25MG
50MG
12.5MG
25MG
50MG
12.5MG
25MG
50MG
12.5MG
25MG
50MG
12.5MG
25MG
50MG
25MG
50MG
12.5MG
25MG
50MG
25MG
50MG
12.5MG
25MG
50MG
CAPSULE, EXTENDED RELEASE;ORAL
PROPAFENONE HYDROCHLORIDE
AB PAR PHARM 225MG
AB 325MG
AB 425MG
3-296( of 362)
A083312 001
A083312 002
A040372 001 Jun 08, 2000
A040515 001 Mar 19, 2003
A040454 001 Aug 22, 2002
A040454 002 Aug 22, 2002
A040785 001 Sep 26, 2008
A040785 002 Sep 26, 2008
A040737 001 Apr 24, 2008
A040737 002 Apr 24, 2008
A040428 002 Mar 31, 2003
A040428 001 Feb 05, 2002
A040500 001 Jun 30, 2003
A040500 002 Jun 30, 2003
A040603 001 Oct 26, 2006
A040603 002 Oct 26, 2006
A040479 001 Jun 24, 2003
A040479 002 Jun 24, 2003
A087165 001 Aug 14, 1987
A040882 001 Dec 30, 2009
A040891 001 Mar 13, 2009
A040026 001 Sep 25, 1998
A040718 001 Apr 04, 2007
A091675 001 Jun 28, 2012
A040643 001 Apr 26, 2006
A087953 001 Nov 15, 1982
A091179 001 Dec 13, 2010
A091179 002 Dec 13, 2010
A091179 003 Dec 13, 2010
A040863 001 Dec 30, 2008
A040863 002 Dec 30, 2008
A040863 003 Dec 30, 2008
A040673 001 Mar 05, 2008
A040673 002 Mar 05, 2008
A040673 003 Mar 05, 2008
A040724 001 Feb 12, 2008
A040724 002 Feb 12, 2008
A040791 001 May 20, 2008
A040712 002 May 04, 2007
A040712 001 Jul 31, 2006
A040713 001 Jul 31, 2006
A091054 001 Aug 30, 2011
A091054 002 Aug 30, 2011
A091054 003 Aug 30, 2011
A084234 001
A084176 001
A040622 001 Jul 18, 2006
A040622 002 Jul 18, 2006
A040622 003 Jul 18, 2006
A083426 001
A083711 001
A040596 001 Nov 18, 2005
A040596 002 Nov 18, 2005
A040596 003 Nov 18, 2005
A078540 001 Oct 18, 2010
A078540 002 Oct 18, 2010
A078540 003 Oct 18, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-297( of 362)
PROPAFENONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
RYTHMOL SR
AB GLAXOSMITHKLINE LLC 225MG N021416 001 Sep 04, 2003
AB 325MG N021416 002 Sep 04, 2003
AB + 425MG N021416 003 Sep 04, 2003
TABLET;ORAL
PROPAFENONE HYDROCHLORIDE
AB MUTUAL PHARM 150MG A075998 001 Nov 29, 2001
AB 225MG A075998 002 Nov 29, 2001
AB 300MG A075998 003 Nov 29, 2001
AB PLIVA 150MG A076550 001 Apr 23, 2004
AB 225MG A076550 002 Apr 23, 2004
AB 300MG A076550 003 Apr 23, 2004
AB VINTAGE PHARMS 150MG A075938 001 Oct 17, 2002
AB 225MG A075938 002 Oct 17, 2002
AB 300MG A075938 003 Oct 17, 2002
AB WATSON LABS 150MG A075203 001 Oct 24, 2000
AB 225MG A075203 002 Oct 24, 2000
RYTHMOL
AB GLAXOSMITHKLINE LLC 150MG N019151 001 Nov 27, 1989
AB 225MG N019151 003 Nov 20, 1992
AB + 300MG N019151 002 Nov 27, 1989
PROPANTHELINE BROMIDE
TABLET;ORAL
PROPANTHELINE BROMIDE
+ ROXANE 15MG A080927 002
PROPARACAINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
ALCAINE
AT ALCON 0.5% A080027 001
OPHTHAINE
AT + APOTHECON 0.5% N008883 001
OPHTHETIC
AT + ALLERGAN 0.5% N012583 001
PROPARACAINE HYDROCHLORIDE
AT AKORN INC 0.5% A040277 001 Mar 16, 2000
AT BAUSCH AND LOMB 0.5% A040074 001 Sep 29, 1995
PROPOFOL
INJECTABLE;INJECTION
DIPRIVAN
AB + FRESENIUS KABI USA 10MG/ML N019627 002 Jun 11, 1996
PROPOFOL
AB HOSPIRA 10MG/ML A077908 001 Mar 17, 2006
AB TEVA PHARMS USA 10MG/ML A075102 001 Jan 04, 1999
PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
INDERAL LA
AB AKRIMAX PHARMS 60MG N018553 004 Mar 18, 1987
AB 80MG N018553 002 Apr 19, 1983
AB 120MG N018553 003 Apr 19, 1983
AB + 160MG N018553 001 Apr 19, 1983
PROPRANOLOL HYDROCHLORIDE
AB ACTAVIS ELIZABETH 60MG A078494 001 Aug 10, 2007
AB 80MG A078494 002 Aug 10, 2007
AB 120MG A078494 003 Aug 10, 2007
AB 160MG A078494 004 Aug 10, 2007
AB APTALIS PHARMATECH 60MG A078703 001 Jul 15, 2011
AB 80MG A078703 002 Jul 15, 2011
AB 120MG A078703 003 Jul 15, 2011
AB 160MG A078703 004 Jul 15, 2011
AB GLATT AIR 60MG A078065 001 Jan 26, 2007
AB 80MG A078065 002 Jan 26, 2007
AB 120MG A078065 003 Jan 26, 2007
AB 160MG A078065 004 Jan 26, 2007
AB MYLAN 60MG A078022 001 Feb 15, 2007
AB 80MG A078022 002 Feb 15, 2007
AB 120MG A078022 003 Feb 15, 2007
AB 160MG A078022 004 Feb 15, 2007
AB UPSHER SMITH 60MG A078311 001 Mar 06, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-298( of 362)
PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
PROPRANOLOL HYDROCHLORIDE
AB 80MG A078311 002 Mar 06, 2009
AB 120MG A078311 003 Mar 06, 2009
AB 160MG A078311 004 Mar 06, 2009
AB ZYDUS PHARMS USA INC 60MG A090321 001 Mar 25, 2011
AB 80MG A090321 002 Mar 25, 2011
AB 120MG A090321 003 Mar 25, 2011
AB 160MG A090321 004 Mar 25, 2011
INNOPRAN XL
BX GLAXOSMITHKLINE LLC 80MG N021438 001 Mar 12, 2003
BX 120MG N021438 002 Mar 12, 2003
INJECTABLE;INJECTION
PROPRANOLOL HYDROCHLORIDE
AP + BAXTER HLTHCARE CORP 1MG/ML N016419 001
AP BEDFORD 1MG/ML A075792 001 Aug 29, 2000
AP FRESENIUS KABI USA 1MG/ML A075826 001 Aug 31, 2001
AP HIKMA FARMACEUTICA 1MG/ML A077760 001 Jan 31, 2008
AP SANDOZ 1MG/ML A076400 001 Feb 26, 2003
SOLUTION;ORAL
PROPRANOLOL HYDROCHLORIDE
+ ROXANE 20MG/5ML A070979 001 May 15, 1987
+ 40MG/5ML A070690 001 May 15, 1987
TABLET;ORAL
INDERAL
AB WYETH PHARMS INC 40MG N016418 002
AB 60MG N016418 009 Oct 18, 1982
AB + 80MG N016418 004
PROPRANOLOL HYDROCHLORIDE
AB IPCA LABS LTD 10MG A078955 001 Jun 02, 2008
AB 20MG A078955 002 Jun 02, 2008
AB 40MG A078955 003 Jun 02, 2008
AB 60MG A078955 004 Jun 02, 2008
AB 80MG A078955 005 Jun 02, 2008
AB MYLAN 10MG A070213 002 Nov 19, 1985
AB 20MG A070213 003 Nov 19, 1985
AB 40MG A070213 001 Nov 19, 1985
AB 60MG A070213 005 Apr 08, 2011
AB 80MG A070213 004 Nov 19, 1985
AB NORTHSTAR HLTHCARE 10MG A078213 001 Jan 10, 2008
AB 20MG A078213 002 Jan 10, 2008
AB 40MG A078213 003 Jan 10, 2008
AB 60MG A078213 004 Jan 10, 2008
AB 80MG A078213 005 Jan 10, 2008
AB PLIVA 10MG A071972 001 Apr 06, 1988
AB 20MG A071973 001 Apr 06, 1988
AB 40MG A071974 001 Apr 06, 1988
AB 60MG A071975 001 Apr 06, 1988
AB + 80MG A071976 001 Apr 06, 1988
AB VINTAGE PHARMS 10MG A070217 001 Aug 01, 1986
AB 20MG A070218 001 Aug 01, 1986
AB 40MG A070219 001 Aug 01, 1986
AB 60MG A070220 001 Sep 24, 1986
AB 80MG A070221 001 Apr 14, 1986
AB WATSON LABS 10MG A070175 001 May 13, 1986
AB 20MG A070176 001 May 13, 1986
AB 40MG A070177 001 May 13, 1986
AB 80MG A070178 001 May 13, 1986
PROPYLTHIOURACIL
TABLET;ORAL
PROPYLTHIOURACIL
BD ACTAVIS ELIZABETH 50MG A080172 001
BD + DAVA PHARMS INC 50MG N006188 001
PROTAMINE SULFATE
INJECTABLE;INJECTION
PROTAMINE SULFATE
+ FRESENIUS KABI USA 10MG/ML A089454 001 Apr 07, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-299( of 362)
PROTRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
PROTRIPTYLINE HYDROCHLORIDE
AB EPIC PHARMA LLC 5MG A202220 001 Nov 19, 2012
AB 10MG A202220 002 Nov 19, 2012
AB ROXANE 5MG A078913 001 Sep 16, 2008
AB 10MG A078913 002 Sep 16, 2008
AB SIGMAPHARM LABS LLC 5MG A090462 001 May 03, 2010
AB 10MG A090462 002 May 03, 2010
VIVACTIL
AB ODYSSEY PHARMS 5MG A073644 001 Aug 24, 1995
AB + 10MG A073645 001 Aug 24, 1995
PYRAZINAMIDE
TABLET;ORAL
PYRAZINAMIDE
AB + DAVA PHARMS INC 500MG A080157 001
AB MIKART 500MG A081319 001 Jun 30, 1992
PYRIDOSTIGMINE BROMIDE
INJECTABLE;INJECTION
MESTINON
AP + VALEANT PHARM INTL 5MG/ML N009830 001
REGONOL
AP SANDOZ 5MG/ML N017398 001
SYRUP;ORAL
MESTINON
+ VALEANT PHARM INTL 60MG/5ML N015193 001
TABLET;ORAL
MESTINON
AB + VALEANT PHARMS LLC 60MG N009829 002
PYRIDOSTIGMINE BROMIDE
AB IMPAX LABS 60MG A040502 001 Apr 24, 2003
TABLET, EXTENDED RELEASE;ORAL
MESTINON
+ VALEANT PHARMS LLC 180MG N011665 001
PYRIDOXINE HYDROCHLORIDE
INJECTABLE;INJECTION
PYRIDOXINE HYDROCHLORIDE
+ FRESENIUS KABI USA 100MG/ML A080618 001
PYRIMETHAMINE
TABLET;ORAL
DARAPRIM
+ AMEDRA PHARMS 25MG N008578 001
QUAZEPAM
TABLET;ORAL
DORAL
+ SCIECURE PHARMA INC 15MG N018708 001 Dec 27, 1985
QUETIAPINE FUMARATE
TABLET;ORAL
QUETIAPINE FUMARATE
AB ACCORD HLTHCARE EQ 25MG BASE A202152 001 Mar 27, 2012
AB EQ 50MG BASE A202152 002 Mar 27, 2012
AB EQ 100MG BASE A202152 003 Mar 27, 2012
AB EQ 200MG BASE A202152 004 Mar 27, 2012
AB EQ 300MG BASE A202152 005 Mar 27, 2012
AB EQ 400MG BASE A202152 006 Mar 27, 2012
AB ACTAVIS GRP PTC EQ 25MG BASE A201762 001 Feb 27, 2013
AB EQ 50MG BASE A201762 002 Feb 27, 2013
AB EQ 100MG BASE A201762 003 Feb 27, 2013
AB EQ 150MG BASE A201762 004 Feb 27, 2013
AB EQ 200MG BASE A201762 005 Feb 27, 2013
AB EQ 300MG BASE A201762 006 Feb 27, 2013
AB EQ 400MG BASE A201762 007 Feb 27, 2013
AB ALKEM LABS LTD EQ 25MG BASE A201504 001 Feb 12, 2013
AB EQ 50MG BASE A201504 002 Feb 12, 2013
AB EQ 100MG BASE A201504 003 Feb 12, 2013
AB EQ 150MG BASE A201504 004 Feb 12, 2013
AB EQ 200MG BASE A201504 005 Feb 12, 2013
AB EQ 300MG BASE A201504 006 Feb 12, 2013
AB EQ 400MG BASE A201504 007 Feb 12, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
QUETIAPINE FUMARATE
TABLET;ORAL
QUETIAPINE FUMARATE
AB APOTEX INC
AB
AB
AB
AB
AB
AB AUROBINDO PHARMA LTD
AB
AB
AB
AB
AB
AB
AB DR REDDYS LABS LTD
AB
AB
AB
AB
AB
AB
AB JUBILANT LIFE
AB LUPIN LTD
AB
AB
AB
AB
AB
AB MYLAN PHARMS INC
AB ROXANE
AB
AB
AB
AB
AB
AB SANDOZ
AB
AB
AB
AB
AB
AB
AB SUN PHARMA GLOBAL
AB
AB
AB
AB
AB
AB TEVA PHARMS
AB
AB
AB
AB
AB
AB
AB TORRENT PHARMS LTD
AB
AB
AB
AB
AB
SEROQUEL
AB + ASTRAZENECA
AB
AB
AB
AB +
AB
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
EQ 25MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
EQ 25MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
3-300( of 362)
A090960 001 Mar 27, 2012
A090960 002 Mar 27, 2012
A090960 003 Mar 27, 2012
A090960 004 Mar 27, 2012
A090960 005 Mar 27, 2012
A090960 006 Mar 27, 2012
A091388 001 Mar 27, 2012
A091388 002 Mar 27, 2012
A091388 003 Mar 27, 2012
A091388 004 Mar 27, 2012
A091388 005 Mar 27, 2012
A091388 006 Mar 27, 2012
A091388 007 Mar 27, 2012
A077380 001 Mar 27, 2012
A077380 002 Mar 27, 2012
A077380 003 Mar 27, 2012
A077380 004 Mar 27, 2012
A077380 005 Mar 27, 2012
A077380 006 Mar 27, 2012
A077380 007 Mar 27, 2012
A203150 001 Nov 26, 2013
A201109 001 Mar 27, 2012
A201109 002 Mar 27, 2012
A201109 003 Mar 27, 2012
A201109 004 Mar 27, 2012
A201109 005 Mar 27, 2012
A201109 006 Mar 27, 2012
A090323 001 Mar 27, 2012
A090120 001 Mar 27, 2012
A090749 001 Mar 27, 2012
A090749 002 Mar 27, 2012
A090749 003 Mar 27, 2012
A090749 004 Mar 27, 2012
A090749 005 Mar 27, 2012
A078679 001 Dec 14, 2012
A078679 002 Dec 14, 2012
A078679 003 Dec 14, 2012
A078679 004 Dec 14, 2012
A078679 005 Dec 14, 2012
A078679 006 Dec 14, 2012
A078679 007 Dec 14, 2012
A201190 001 Mar 27, 2012
A201190 002 Mar 27, 2012
A201190 003 Mar 27, 2012
A201190 004 Mar 27, 2012
A201190 005 Mar 27, 2012
A201190 006 Mar 27, 2012
A077745 001 Mar 27, 2012
A077745 002 Mar 27, 2012
A077745 003 Mar 27, 2012
A077745 004 Mar 27, 2012
A077745 005 Mar 27, 2012
A077745 006 Mar 27, 2012
A077745 007 Mar 27, 2012
A200363 001 Mar 27, 2012
A200363 002 Mar 27, 2012
A200363 003 Mar 27, 2012
A200363 004 Mar 27, 2012
A200363 005 Mar 27, 2012
A200363 006 Mar 27, 2012
N020639 001 Sep 26, 1997
N020639 007 Oct 04, 2005
N020639 002 Sep 26, 1997
N020639 003 Sep 26, 1997
N020639 005 Jul 26, 2000
N020639 006 Oct 04, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-301( of 362)
QUETIAPINE FUMARATE
TABLET, EXTENDED RELEASE;ORAL
SEROQUEL XR
ASTRAZENECA EQ 50MG BASE N022047 001 May 17, 2007
EQ 150MG BASE N022047 005 Aug 11, 2008
+ EQ 200MG BASE N022047 002 May 17, 2007
EQ 300MG BASE N022047 003 May 17, 2007
EQ 400MG BASE N022047 004 May 17, 2007
QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
ACCUPRIL
AB PFIZER PHARMS EQ 5MG BASE N019885 001 Nov 19, 1991
AB EQ 10MG BASE N019885 002 Nov 19, 1991
AB EQ 20MG BASE N019885 003 Nov 19, 1991
AB + EQ 40MG BASE N019885 004 Nov 19, 1991
QUINAPRIL HYDROCHLORIDE
AB AUROBINDO PHARMA LTD EQ 5MG BASE A202725 001 Apr 29, 2013
AB EQ 10MG BASE A202725 002 Apr 29, 2013
AB EQ 20MG BASE A202725 003 Apr 29, 2013
AB EQ 40MG BASE A202725 004 Apr 29, 2013
AB INVAGEN PHARMS EQ 5MG BASE A078457 001 Aug 24, 2007
AB EQ 10MG BASE A078457 002 Aug 24, 2007
AB EQ 20MG BASE A078457 003 Aug 24, 2007
AB EQ 40MG BASE A078457 004 Aug 24, 2007
AB LUPIN EQ 5MG BASE A077690 001 Jun 20, 2006
AB EQ 10MG BASE A077690 002 Jun 20, 2006
AB EQ 20MG BASE A077690 003 Jun 20, 2006
AB EQ 40MG BASE A077690 004 Jun 20, 2006
AB MYLAN EQ 5MG BASE A076694 001 Dec 23, 2004
AB EQ 10MG BASE A076694 002 Dec 23, 2004
AB EQ 20MG BASE A076694 003 Dec 23, 2004
AB EQ 40MG BASE A076694 004 Dec 23, 2004
AB RANBAXY EQ 5MG BASE A076607 001 Dec 15, 2004
AB EQ 10MG BASE A076607 002 Dec 15, 2004
AB EQ 20MG BASE A076607 003 Dec 15, 2004
AB EQ 40MG BASE A076607 004 Dec 15, 2004
AB SUN PHARM INDS LTD EQ 5MG BASE A090800 001 Jun 18, 2009
AB EQ 10MG BASE A090800 002 Jun 18, 2009
AB EQ 20MG BASE A090800 003 Jun 18, 2009
AB EQ 40MG BASE A090800 004 Jun 18, 2009
AB TEVA EQ 5MG BASE A075504 001 Aug 24, 2007
AB EQ 10MG BASE A075504 002 Aug 24, 2007
AB EQ 20MG BASE A075504 003 Aug 24, 2007
AB EQ 40MG BASE A075504 004 Aug 24, 2007
AB WATSON LABS FLORIDA EQ 5MG BASE A076049 001 Jan 14, 2005
AB EQ 10MG BASE A076049 002 Jan 14, 2005
AB EQ 20MG BASE A076049 003 Jan 14, 2005
AB EQ 40MG BASE A076049 004 Jan 14, 2005
QUINIDINE GLUCONATE
INJECTABLE;INJECTION
QUINIDINE GLUCONATE
+ LILLY 80MG/ML N007529 002 Feb 10, 1989
TABLET, EXTENDED RELEASE;ORAL
QUINIDINE GLUCONATE
BX + MUTUAL PHARM 324MG A089338 001 Feb 11, 1987
BX WATSON LABS 324MG A087810 001 Sep 29, 1982
QUINIDINE SULFATE
TABLET;ORAL
QUINIDINE SULFATE
AB MUTUAL PHARM 200MG A081030 001 Apr 14, 1989
AB 300MG A081031 001 Apr 14, 1989
AB SANDOZ 200MG A088072 002
AB 300MG A088072 001 Sep 26, 1983
AB + WATSON LABS 200MG A083288 001
AB + 300MG A085583 001
TABLET, EXTENDED RELEASE;ORAL
QUINIDINE SULFATE
+ TEVA PHARMS 300MG A040045 001 Jun 30, 1994
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-302( of 362)
QUININE SULFATE
CAPSULE;ORAL
QUALAQUIN
AB + MUTUAL PHARM CO INC 324MG N021799 001 Aug 12, 2005
QUININE SULFATE
AB MYLAN PHARMS INC 324MG A202581 001 Dec 14, 2012
AB TEVA PHARMS 324MG A091661 001 Sep 28, 2012
RABEPRAZOLE SODIUM
CAPSULE, DELAYED RELEASE;ORAL
ACIPHEX SPRINKLE
EISAI INC 5MG N204736 001 Mar 26, 2013
+ 10MG N204736 002 Mar 26, 2013
TABLET, DELAYED RELEASE;ORAL
ACIPHEX
AB + EISAI INC 20MG N020973 002 Aug 19, 1999
RABEPRAZOLE SODIUM
AB DR REDDYS LABS LTD 20MG A076824 001 Nov 08, 2013
AB KREMERS URBAN DEV 20MG A090678 001 Nov 08, 2013
AB LUPIN LTD 20MG A078964 001 Nov 08, 2013
AB MYLAN PHARMS INC 20MG A076885 001 Nov 08, 2013
AB TEVA PHARMS USA 20MG A076822 001 Nov 08, 2013
AB TORRENT PHARMS LTD 20MG A202376 001 Nov 08, 2013
RADIUM RA-223 DICHLORIDE
SOLUTION;INTRAVENOUS
XOFIGO
+ BAYER HLTHCARE 162mCi/6ML (27mCi/ML) N203971 001 May 15, 2013
RALOXIFENE HYDROCHLORIDE
TABLET;ORAL
EVISTA
+ LILLY 60MG N020815 001 Dec 09, 1997
RALTEGRAVIR POTASSIUM
POWDER;ORAL
ISENTRESS
+ MERCK SHARP DOHME EQ 100MG BASE/PACKET N205786 001 Dec 20, 2013
TABLET;ORAL
ISENTRESS
+ MERCK SHARP DOHME EQ 400MG BASE N022145 001 Oct 12, 2007
TABLET, CHEWABLE;ORAL
ISENTRESS
MERCK SHARP DOHME EQ 25MG BASE N203045 001 Dec 21, 2011
+ EQ 100MG BASE N203045 002 Dec 21, 2011
RAMELTEON
TABLET;ORAL
RAMELTEON
AB TEVA PHARMS USA 8MG A091693 001 Jul 26, 2013
ROZEREM
AB + TAKEDA PHARMS USA 8MG N021782 001 Jul 22, 2005
RAMIPRIL
CAPSULE;ORAL
ALTACE
AB KING PHARMS 1.25MG N019901 001 Jan 28, 1991
AB 2.5MG N019901 002 Jan 28, 1991
AB 5MG N019901 003 Jan 28, 1991
AB + 10MG N019901 004 Jan 28, 1991
RAMIPRIL
AB APOTEX 1.25MG A079116 001 Jun 20, 2008
AB 2.5MG A079116 002 Jun 20, 2008
AB 5MG A079116 003 Jun 20, 2008
AB 10MG A079116 004 Jun 20, 2008
AB AUROBINDO PHARMA LTD 1.25MG A091604 001 Jun 08, 2011
AB 2.5MG A091604 002 Jun 08, 2011
AB 5MG A091604 003 Jun 08, 2011
AB 10MG A091604 004 Jun 08, 2011
AB DR REDDYS LABS LTD 1.25MG A078191 001 Jun 18, 2008
AB 2.5MG A078191 002 Jun 18, 2008
AB 5MG A078191 003 Jun 18, 2008
AB 10MG A078191 004 Jun 18, 2008
AB INVAGEN PHARMS 1.25MG A078745 001 Jun 18, 2008
AB 2.5MG A078745 002 Jun 18, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
RAMIPRIL
CAPSULE;ORAL
RAMIPRIL
AB
AB
AB LUPIN
AB
AB
AB
AB ROXANE
AB
AB
AB
AB SANDOZ
AB
AB
AB
AB TEVA PHARMS
AB
AB
AB
AB WATSON LABS
AB
AB
AB
AB ZYDUS PHARMS USA
AB
AB
AB
TABLET;ORAL
RAMIPRIL
AB MYLAN PHARMS INC
AB
AB
AB
AB ZYDUS PHARMS USA INC
AB
AB
AB
RANITIDINE HYDROCHLORIDE
CAPSULE;ORAL
RANITIDINE HYDROCHLORIDE
AB DR REDDYS LABS LTD
AB
AB SANDOZ
AB +
INJECTABLE;INJECTION
RANITIDINE HYDROCHLORIDE
AP BEDFORD
AP BEN VENUE
AP ZYDUS PHARMS USA INC
ZANTAC
AP + COVIS PHARMA
SYRUP;ORAL
RANITIDINE HYDROCHLORIDE
AA ACTAVIS MID ATLANTIC
AA AMNEAL PHARMS
AA AUROBINDO PHARM
AA BIO PHARM INC
AA BRECKENRIDGE PHARM
AA CARACO
AA HI TECH PHARMA
AA PHARM ASSOC
AA SILARX
AA TARO
AA TOLMAR
AA VINTAGE PHARMS
AA WOCKHARDT
AA
ZANTAC
AA + GLAXO GRP LTD
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 25MG BASE/ML
EQ 25MG BASE/ML
25MG/ML
EQ 25MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
EQ 15MG BASE/ML
3-303( of 362)
A078745 003 Jun 18, 2008
A078745 004 Jun 18, 2008
A077626 001 Jun 09, 2008
A077626 002 Jun 09, 2008
A077626 003 Jun 09, 2008
A077626 004 Jun 09, 2008
A077900 001 Jun 18, 2008
A077900 002 Jun 18, 2008
A077900 003 Jun 18, 2008
A077900 004 Jun 18, 2008
A077514 001 Jun 18, 2008
A077514 002 Jun 18, 2008
A077514 003 Jun 18, 2008
A077514 004 Jun 18, 2008
A077470 001 Jun 18, 2008
A077470 002 Jun 18, 2008
A077470 003 Jun 18, 2008
A077470 004 Jun 18, 2008
A076549 001 Oct 24, 2005
A076549 002 Oct 24, 2005
A076549 003 Oct 24, 2005
A076549 004 Oct 24, 2005
A078832 001 Sep 02, 2008
A078832 002 Sep 02, 2008
A078832 003 Sep 02, 2008
A078832 004 Sep 02, 2008
A090650 001 Jun 30, 2011
A090650 002 Jun 30, 2011
A090650 003 Jun 30, 2011
A090650 004 Jun 30, 2011
A090697 001 Sep 24, 2009
A090697 002 Sep 24, 2009
A090697 003 Sep 24, 2009
A090697 004 Sep 24, 2009
A075742 001 Nov 29, 2000
A075742 002 Nov 29, 2000
A074655 001 Oct 22, 1997
A074655 002 Oct 22, 1997
A077458 001 Feb 16, 2006
A074777 001 Mar 02, 2005
A091534 001 Feb 22, 2013
N019090 001 Oct 19, 1984
A076124 001 Feb 21, 2007
A078312 001 Sep 02, 2008
A090623 001 Jul 28, 2010
A090102 001 May 26, 2009
A078684 001 Aug 27, 2009
A091091 001 Sep 20, 2011
A091078 001 Mar 22, 2011
A077405 001 Sep 21, 2007
A091288 001 Dec 09, 2010
A077476 001 Jun 13, 2011
A090054 001 Nov 15, 2010
A078890 001 Jul 01, 2010
A079211 001 May 26, 2009
A079212 001 Feb 23, 2009
N019675 001 Dec 30, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
RANITIDINE HYDROCHLORIDE
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
AB AMNEAL PHARMS NY
AB
AB APOTEX
AB
AB DR REDDYS LABS INC
AB
AB GLENMARK GENERICS
AB
AB IVAX SUB TEVA PHARMS
AB
AB MYLAN
AB
AB PAR PHARM
AB
AB SANDOZ
AB
AB TEVA
AB
AB WOCKHARDT
AB
AB
AB
ZANTAC 150
AB GLAXO GRP LTD
ZANTAC 300
AB + GLAXO GRP LTD
TABLET, EFFERVESCENT;ORAL
ZANTAC 25
+ GLAXO GRP LTD
RANOLAZINE
TABLET, EXTENDED RELEASE;ORAL
RANEXA
AB + GILEAD
AB
RANOLAZINE
AB LUPIN LTD
AB
RASAGILINE MESYLATE
TABLET;ORAL
AZILECT
AB TEVA
AB +
RASAGILINE MESYLATE
AB APOTEX INC
AB
AB WATSON LABS INC
AB
REGADENOSON
SOLUTION;INTRAVENOUS
LEXISCAN
+ ASTELLAS
REGORAFENIB
TABLET;ORAL
STIVARGA
+ BAYER HLTHCARE
REMIFENTANIL HYDROCHLORIDE
INJECTABLE;INJECTION
ULTIVA
MYLAN INSTITUTIONAL
+
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 25MG BASE
1GM
500MG
500MG
1GM
EQ 0.5MG BASE
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
0.4MG/5ML (0.08MG/ML)
40MG
EQ 1MG BASE/VIAL
EQ 2MG BASE/VIAL
EQ 5MG BASE/VIAL
3-304( of 362)
A077824 001 Oct 13, 2006
A077824 002 Oct 13, 2006
A074680 001 Sep 12, 1997
A074680 002 Sep 12, 1997
A076705 001 Jul 27, 2005
A076705 002 Jul 27, 2005
A078542 001 Nov 19, 2008
A078542 002 Nov 19, 2008
A075165 001 Sep 30, 1998
A075165 002 Sep 30, 1998
A074023 001 Aug 22, 1997
A074023 002 Aug 22, 1997
A075180 001 Jan 28, 1999
A075180 002 Jan 28, 1999
A074467 001 Aug 29, 1997
A074467 002 Aug 29, 1997
A074488 001 Jul 31, 1997
A074488 002 Jul 31, 1997
A075208 001 Dec 17, 1998
A078701 001 Nov 12, 2009
A075208 002 Dec 17, 1998
A078701 002 Dec 11, 2009
N018703 001 Jun 09, 1983
N018703 002 Dec 09, 1985
N020251 003 Apr 01, 2004
N021526 001 Feb 12, 2007
N021526 002 Jan 27, 2006
A201046 001 Jul 29, 2013
A201046 002 Jul 29, 2013
N021641 001 May 16, 2006
N021641 002 May 16, 2006
A201950 001 Sep 12, 2013
A201950 002 Sep 12, 2013
A201823 001 Jul 01, 2013
A201823 002 Jul 01, 2013
N022161 001 Apr 10, 2008
N203085 001 Sep 27, 2012
N020630 001 Jul 12, 1996
N020630 002 Jul 12, 1996
N020630 003 Jul 12, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-305( of 362)
REPAGLINIDE
TABLET;ORAL
PRANDIN
AB NOVO NORDISK INC 0.5MG N020741 001 Dec 22, 1997
AB 1MG N020741 002 Dec 22, 1997
AB + 2MG N020741 003 Dec 22, 1997
REPAGLINIDE
AB CARACO 1MG A077571 002 Jul 11, 2013
AB 2MG A077571 003 Jul 11, 2013
AB MYLAN PHARMS INC 0.5MG A090252 001 Aug 23, 2013
AB PADDOCK LLC 0.5MG A201189 001 Jul 17, 2013
AB SANDOZ 0.5MG A078555 001 Nov 22, 2013
RESERPINE
TABLET;ORAL
RESERPINE
BP SANDOZ 0.1MG N009838 001
BP + 0.25MG N009838 002
RETAPAMULIN
OINTMENT;TOPICAL
ALTABAX
+ GLAXO GRP LTD 1% N022055 001 Apr 12, 2007
RIBAVIRIN
CAPSULE;ORAL
REBETOL
AB + MERCK SHARP DOHME 200MG N020903 002 Jul 25, 2001
RIBASPHERE
AB THREE RIVERS PHARMS 200MG A076203 001 Apr 06, 2004
RIBAVARIN
AB AUROBINDO PHARMA 200MG A079117 001 Sep 17, 2009
RIBAVIRIN
AB SANDOZ 200MG A076192 001 Apr 06, 2004
AB TEVA 200MG A076277 001 Oct 04, 2004
AB ZYDUS PHARMS USA 200MG A077224 001 Oct 28, 2005
REBETOL
+ MERCK SHARP DOHME 200MG**Indicated for use and comarketed N020903 001 Jun 03, 1998
with Interferon ALFA-2B, Recombinant
(INTRON A), as Rebetron Combination
Therapy**
FOR SOLUTION;INHALATION
VIRAZOLE
+ VALEANT PHARM INTL 6GM/VIAL N018859 001 Dec 31, 1985
SOLUTION;ORAL
REBETOL
+ SCHERING 40MG/ML N021546 001 Jul 29, 2003
TABLET;ORAL
COPEGUS
AB ROCHE 200MG N021511 001 Dec 03, 2002
RIBAVIRIN
AB AUROBINDO PHARMA 200MG A079111 001 Sep 17, 2009
AB SANDOZ 200MG A077743 001 Oct 03, 2006
AB TEVA 200MG A077053 001 Dec 05, 2005
AB THREE RIVERS PHARMS 200MG A077456 001 Dec 05, 2005
AB 400MG A077456 002 Dec 05, 2005
AB + 600MG A077456 003 Dec 05, 2005
AB ZYDUS PHARMS USA 200MG A077094 001 Dec 05, 2005
AB 400MG A077094 002 Mar 16, 2007
AB 600MG A077094 003 Mar 16, 2007
500MG A077094 004 Apr 18, 2008
RIFABUTIN
CAPSULE;ORAL
MYCOBUTIN
+ PHARMACIA AND UPJOHN 150MG N050689 001 Dec 23, 1992
RIFAMPIN
CAPSULE;ORAL
RIFADIN
AB SANOFI AVENTIS US 150MG A062303 001
AB + 300MG N050420 001
RIFAMPIN
AB LANNETT 150MG A065390 001 Mar 28, 2008
AB 300MG A065390 002 Mar 28, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-306( of 362)
RIFAMPIN
CAPSULE;ORAL
RIFAMPIN
AB LUPIN PHARMS 150MG A090034 001 Aug 21, 2013
AB 300MG A090034 002 Aug 21, 2013
AB SANDOZ 150MG A064150 002 Jan 02, 1998
AB 300MG A064150 001 May 28, 1997
AB VERSAPHARM 150MG A065028 001 Mar 14, 2001
AB 300MG A065028 002 Mar 14, 2001
RIMACTANE
AB PROSAM LABS 300MG N050429 001
INJECTABLE;INJECTION
RIFADIN
AP + SANOFI AVENTIS US 600MG/VIAL N050627 001 May 25, 1989
RIFAMPIN
AP AGILA SPECLTS 600MG/VIAL A065421 001 May 22, 2008
AP BEDFORD 600MG/VIAL A064217 001 Oct 29, 1999
AP VERSAPHARM INC 600MG/VIAL A065502 001 Sep 21, 2010
RIFAPENTINE
TABLET;ORAL
PRIFTIN
+ SANOFI AVENTIS US 150MG N021024 001 Jun 22, 1998
RIFAXIMIN
TABLET;ORAL
XIFAXAN
+ SALIX PHARMS 200MG N021361 001 May 25, 2004
+ 550MG N022554 001 Mar 24, 2010
RILPIVIRINE HYDROCHLORIDE
TABLET;ORAL
EDURANT
+ JANSSEN PRODS EQ 25MG BASE N202022 001 May 20, 2011
RILUZOLE
TABLET;ORAL
RILUTEK
AB + COVIS PHARMA SARL 50MG N020599 001 Dec 12, 1995
RILUZOLE
AB APOTEX CORP 50MG A091300 001 Jun 18, 2013
AB GLENMARK GENERICS 50MG A091394 001 Jun 18, 2013
AB IMPAX LABS 50MG A076173 001 Jan 29, 2003
AB MYLAN PHARMS INC 50MG A203042 001 Jul 01, 2013
AB SUN PHARM INDS LTD 50MG A091417 001 Jun 18, 2013
RIMANTADINE HYDROCHLORIDE
TABLET;ORAL
FLUMADINE
AB + CARACO 100MG N019649 001 Sep 17, 1993
RIMANTADINE HYDROCHLORIDE
AB IMPAX LABS 100MG A076132 001 Aug 30, 2002
RIMEXOLONE
SUSPENSION/DROPS;OPHTHALMIC
VEXOL
+ ALCON 1% N020474 001 Dec 30, 1994
RIOCIGUAT
TABLET;ORAL
ADEMPAS
BAYER HLTHCARE 0.5MG N204819 001 Oct 08, 2013
1MG N204819 002 Oct 08, 2013
1.5MG N204819 003 Oct 08, 2013
2MG N204819 004 Oct 08, 2013
+ 2.5MG N204819 005 Oct 08, 2013
RISEDRONATE SODIUM
TABLET;ORAL
ACTONEL
AB WARNER CHILCOTT LLC 5MG N020835 002 Apr 14, 2000
AB 30MG N020835 001 Mar 27, 1998
AB + 35MG N020835 003 May 25, 2002
RISEDRONATE SODIUM
AB TEVA PHARMS 5MG A077132 001 Oct 05, 2007
AB 30MG A077132 002 Oct 05, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-307( of 362)
RISEDRONATE SODIUM
TABLET;ORAL
RISEDRONATE SODIUM
AB 35MG A077132 003 Oct 05, 2007
ACTONEL
+ WARNER CHILCOTT LLC 150MG N020835 005 Apr 22, 2008
TABLET, DELAYED RELEASE;ORAL
ATELVIA
+ WARNER CHILCOTT LLC 35MG N022560 001 Oct 08, 2010
RISPERIDONE
INJECTABLE;INTRAMUSCULAR
RISPERDAL CONSTA
JANSSEN PHARMS 12.5MG/VIAL N021346 004 Apr 12, 2007
+ 25MG/VIAL N021346 001 Oct 29, 2003
37.5MG/VIAL N021346 002 Oct 29, 2003
50MG/VIAL N021346 003 Oct 29, 2003
SOLUTION;ORAL
RISPERDAL
AA + JANSSEN PHARMS 1MG/ML N020588 001 Jun 10, 1996
RISPERIDONE
AA AMNEAL PHARMS 1MG/ML A091384 001 May 25, 2011
AA APOTEX INC 1MG/ML A077719 001 Jul 29, 2009
AA AUROBINDO PHARMA 1MG/ML A078452 001 Sep 04, 2009
AA BIO PHARM INC 1MG/ML A078909 001 Jul 29, 2009
AA PRECISION DOSE 1MG/ML A076797 001 Jun 28, 2010
AA ROXANE 1MG/ML A076904 001 Jul 29, 2009
AA TARO 1MG/ML A090347 001 Feb 07, 2011
AA TEVA 1MG/ML A076440 001 Jan 30, 2009
AA TRIS PHARMA INC 1MG/ML A079059 001 Dec 12, 2012
AA VINTAGE 1MG/ML A079158 001 Dec 03, 2010
AA WOCKHARDT 1MG/ML A078744 001 Oct 08, 2009
TABLET;ORAL
RISPERDAL
AB JANSSEN PHARMS 0.25MG N020272 008 May 10, 1999
AB 0.5MG N020272 007 Jan 27, 1999
AB + 1MG N020272 001 Dec 29, 1993
AB 2MG N020272 002 Dec 29, 1993
AB 3MG N020272 003 Dec 29, 1993
AB 4MG N020272 004 Dec 29, 1993
RISPERIDONE
AB AJANTA PHARMA LTD 0.25MG A201003 001 Aug 24, 2011
AB 0.5MG A201003 002 Aug 24, 2011
AB 1MG A201003 003 Aug 24, 2011
AB 2MG A201003 004 Aug 24, 2011
AB 3MG A201003 005 Aug 24, 2011
AB 4MG A201003 006 Aug 24, 2011
AB APOTEX INC 0.25MG A077953 001 Sep 15, 2008
AB 0.5MG A077953 002 Sep 15, 2008
AB 1MG A077953 003 Sep 15, 2008
AB 2MG A077953 004 Sep 15, 2008
AB 3MG A077953 005 Sep 15, 2008
AB 4MG A077953 006 Sep 15, 2008
AB AUROBINDO PHARMA 0.25MG A078269 001 Oct 08, 2008
AB 0.5MG A078269 002 Oct 08, 2008
AB 1MG A078269 003 Oct 08, 2008
AB 2MG A078269 004 Oct 08, 2008
AB 3MG A078269 005 Oct 08, 2008
AB 4MG A078269 006 Oct 08, 2008
AB CIPLA 0.25MG A077543 001 May 18, 2011
AB 0.5MG A077543 002 May 18, 2011
AB 1MG A077543 003 May 18, 2011
AB 2MG A077543 004 May 18, 2011
AB 3MG A077543 005 May 18, 2011
AB 4MG A077543 006 May 18, 2011
AB DR REDDYS LABS LTD 0.25MG A076879 001 Oct 24, 2008
AB 0.5MG A076879 002 Oct 24, 2008
AB 1MG A076879 003 Oct 24, 2008
AB 2MG A076879 004 Oct 24, 2008
AB 3MG A076879 005 Oct 24, 2008
AB 4MG A076879 006 Oct 24, 2008
AB MYLAN 0.25MG A076288 001 Sep 15, 2008
AB 0.5MG A076288 002 Sep 15, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
RISPERIDONE
TABLET;ORAL
RISPERIDONE
AB 1MG
AB 2MG
AB 3MG
AB 4MG
AB PLIVA HRVATSKA DOO 0.25MG
AB 0.5MG
AB 1MG
AB 2MG
AB 3MG
AB 4MG
AB PRINSTON INC 0.25MG
AB 0.5MG
AB 1MG
AB 2MG
AB 3MG
AB 4MG
AB PROSAM LABS 0.25MG
AB 0.5MG
AB 1MG
AB 2MG
AB 3MG
AB 4MG
AB SANDOZ 0.25MG
AB 0.5MG
AB 1MG
AB 2MG
AB 3MG
AB 4MG
AB TEVA 0.25MG
AB 0.5MG
AB 1MG
AB 2MG
AB 3MG
AB 4MG
AB TORRENT PHARMS 0.25MG
AB 0.5MG
AB 1MG
AB 2MG
AB 3MG
AB 4MG
AB VINTAGE 0.25MG
AB 0.5MG
AB 1MG
AB 2MG
AB 3MG
AB 4MG
AB WATSON LABS 0.25MG
AB 0.5MG
AB 1MG
AB 2MG
AB 3MG
AB 4MG
AB WEST WARD PHARMS 0.25MG
AB 0.5MG
AB 1MG
AB 2MG
AB 3MG
AB 4MG
AB WOCKHARDT 0.25MG
AB 0.5MG
AB 1MG
AB 2MG
AB 3MG
AB 4MG
AB ZYDUS PHARMS USA INC 0.25MG
AB 0.5MG
AB 1MG
AB 2MG
AB 3MG
3-308( of 362)
A076288 003 Sep 15, 2008
A076288 004 Sep 15, 2008
A076288 005 Sep 15, 2008
A076288 006 Sep 15, 2008
A077769 001 Oct 16, 2008
A077769 002 Oct 16, 2008
A077769 003 Oct 16, 2008
A077769 004 Oct 16, 2008
A077769 005 Oct 16, 2008
A077769 006 Oct 16, 2008
A077493 001 Nov 29, 2011
A077493 002 Nov 29, 2011
A077493 003 Nov 29, 2011
A077493 004 Nov 29, 2011
A077493 005 Nov 29, 2011
A077493 006 Nov 29, 2011
A078071 001 Jun 17, 2009
A078071 002 Jun 17, 2009
A078071 003 Jun 17, 2009
A078071 004 Jun 17, 2009
A078071 005 Jun 17, 2009
A078071 006 Jun 17, 2009
A078528 001 Oct 16, 2009
A078528 002 Oct 16, 2009
A078528 003 Oct 16, 2009
A078528 004 Oct 16, 2009
A078528 005 Oct 16, 2009
A078528 006 Oct 16, 2009
A076228 001 Jun 30, 2008
A076228 002 Jun 30, 2008
A076228 003 Jun 30, 2008
A076228 004 Jun 30, 2008
A076228 005 Jun 30, 2008
A076228 006 Jun 30, 2008
A079088 001 Oct 30, 2008
A079088 002 Oct 30, 2008
A079088 003 Oct 30, 2008
A079088 004 Oct 30, 2008
A079088 005 Oct 30, 2008
A079088 006 Oct 30, 2008
A078707 001 Dec 29, 2008
A078707 002 Dec 29, 2008
A078707 003 Dec 29, 2008
A078707 004 Dec 29, 2008
A078707 005 Dec 29, 2008
A078707 006 Dec 29, 2008
A077860 001 Dec 05, 2008
A077860 002 Dec 05, 2008
A077860 003 Dec 05, 2008
A077860 004 Dec 05, 2008
A077860 005 Dec 05, 2008
A077860 006 Dec 05, 2008
A078740 001 May 29, 2009
A078740 002 May 29, 2009
A078740 003 May 29, 2009
A078740 004 May 29, 2009
A078740 005 May 29, 2009
A078740 006 May 29, 2009
A078871 001 Oct 09, 2008
A078871 002 Oct 09, 2008
A078871 003 Oct 09, 2008
A078871 004 Oct 09, 2008
A078871 005 Oct 09, 2008
A078871 006 Oct 09, 2008
A078040 001 Oct 16, 2008
A078040 002 Oct 16, 2008
A078040 003 Oct 16, 2008
A078040 004 Oct 16, 2008
A078040 005 Oct 16, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
RISPERIDONE
TABLET;ORAL
RISPERIDONE
AB 4MG
TABLET, ORALLY DISINTEGRATING;ORAL
RISPERDAL
AB JANSSEN PHARMS
AB +
AB
AB
AB
RISPERIDONE
AB DR REDDYS LABS LTD
AB
AB
AB JUBILANT ORGANOSYS
AB
AB
AB
AB
AB MYLAN PHARMS INC
AB
AB
AB
AB
AB
AB PAR PHARM
AB
AB
AB
AB
AB
AB RANBAXY
AB
AB
AB
AB
AB SANDOZ
AB
AB
AB
AB
AB SUN PHARM INDS LTD
AB
AB
AB
AB
AB TEVA
AB
AB
AB WATSON LABS FLORIDA
AB
AB
AB
AB
AB ZYDUS PHARMS USA
AB
RITONAVIR
CAPSULE;ORAL
NORVIR
+ ABBVIE
SOLUTION;ORAL
NORVIR
+ ABBVIE
TABLET;ORAL
NORVIR
+ ABBVIE
0.5MG
1MG
2MG
3MG
4MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.5MG
1MG
2MG
3MG
4MG
0.5MG
1MG
2MG
3MG
4MG
0.5MG
1MG
2MG
3MG
4MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
3MG
4MG
0.5MG
2MG
100MG
80MG/ML
100MG
3-309( of 362)
A078040 006 Oct 16, 2008
N021444 001 Apr 02, 2003
N021444 002 Apr 02, 2003
N021444 003 Apr 02, 2003
N021444 004 Dec 23, 2004
N021444 005 Dec 23, 2004
A077328 001 Feb 24, 2009
A077328 002 Oct 05, 2009
A077328 003 Feb 24, 2009
A090839 001 Nov 04, 2011
A090839 002 Nov 04, 2011
A090839 003 Nov 04, 2011
A090839 004 Nov 04, 2011
A090839 005 Nov 04, 2011
A091537 006 Feb 12, 2013
A091537 001 Mar 30, 2011
A091537 002 Mar 30, 2011
A091537 003 Mar 30, 2011
A091537 004 Mar 30, 2011
A091537 005 Mar 30, 2011
A077494 001 Apr 30, 2009
A077494 002 Apr 30, 2009
A077494 003 Oct 26, 2009
A077494 004 Apr 30, 2009
A077494 005 Apr 30, 2009
A077494 006 Apr 30, 2009
A077542 001 Aug 06, 2010
A077542 002 Aug 06, 2010
A077542 003 Aug 06, 2010
A078474 001 Aug 06, 2010
A078474 002 Aug 06, 2010
A078116 001 Dec 22, 2009
A078116 002 Dec 22, 2009
A078116 003 Dec 22, 2009
A078116 004 Dec 22, 2009
A078116 005 Dec 22, 2009
A078464 001 Apr 08, 2013
A078464 002 Apr 08, 2013
A078464 003 Apr 08, 2013
A078464 004 Apr 08, 2013
A078464 005 Apr 08, 2013
A076908 001 Mar 12, 2012
A076908 002 Mar 12, 2012
A076908 003 Mar 12, 2012
A076996 001 Apr 19, 2011
A076996 002 Apr 19, 2011
A076996 003 Apr 19, 2011
A076996 004 Apr 19, 2011
A076996 005 Apr 19, 2011
A078516 001 May 01, 2009
A078516 003 May 01, 2009
N020945 001 Jun 29, 1999
N020659 001 Mar 01, 1996
N022417 001 Feb 10, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-310( of 362)
RIVAROXABAN
TABLET;ORAL
XARELTO
+ JANSSEN PHARMS 10MG N022406 001 Jul 01, 2011
15MG N022406 002 Nov 04, 2011
+ 20MG N022406 003 Nov 04, 2011
RIVASTIGMINE
FILM, EXTENDED RELEASE;TRANSDERMAL
EXELON
NOVARTIS 4.6MG/24HR N022083 001 Jul 06, 2007
+ 9.5MG/24HR N022083 002 Jul 06, 2007
13.3MG/24HR N022083 005 Aug 31, 2012
RIVASTIGMINE TARTRATE
CAPSULE;ORAL
EXELON
AB + NOVARTIS EQ 1.5MG BASE N020823 003 Apr 21, 2000
AB EQ 3MG BASE N020823 004 Apr 21, 2000
AB EQ 4.5MG BASE N020823 005 Apr 21, 2000
AB EQ 6MG BASE N020823 006 Apr 21, 2000
RIVASTIGMINE TARTRATE
AB ALEMBIC PHARMS LTD EQ 1.5MG BASE A091689 001 Jun 12, 2012
AB EQ 3MG BASE A091689 002 Jun 12, 2012
AB EQ 4.5MG BASE A091689 003 Jun 12, 2012
AB EQ 6MG BASE A091689 004 Jun 12, 2012
AB APOTEX INC EQ 1.5MG BASE A091072 001 May 16, 2013
AB EQ 3MG BASE A091072 002 May 16, 2013
AB EQ 4.5MG BASE A091072 003 May 16, 2013
AB EQ 6MG BASE A091072 004 May 16, 2013
AB DR REDDYS LABS INC EQ 1.5MG BASE A077130 001 Oct 31, 2007
AB EQ 3MG BASE A077130 002 Oct 31, 2007
AB EQ 4.5MG BASE A077130 003 Oct 31, 2007
AB EQ 6MG BASE A077130 004 Oct 31, 2007
AB SUN PHARM INDS EQ 1.5MG BASE A077131 001 Oct 22, 2007
AB EQ 3MG BASE A077131 002 Oct 22, 2007
AB EQ 4.5MG BASE A077131 003 Oct 22, 2007
AB EQ 6MG BASE A077131 004 Oct 22, 2007
AB WATSON LABS EQ 1.5MG BASE A077129 001 Jan 08, 2008
AB EQ 3MG BASE A077129 002 Jan 08, 2008
AB EQ 4.5MG BASE A077129 003 Jan 08, 2008
AB EQ 6MG BASE A077129 004 Jan 08, 2008
SOLUTION;ORAL
EXELON
+ NOVARTIS EQ 2MG BASE/ML N021025 001 Apr 21, 2000
RIZATRIPTAN BENZOATE
TABLET;ORAL
MAXALT
AB MERCK EQ 5MG BASE N020864 001 Jun 29, 1998
AB + EQ 10MG BASE N020864 002 Jun 29, 1998
RIZATRIPTAN BENZOATE
AB APOTEX INC EQ 5MG BASE A202244 001 Dec 31, 2012
AB EQ 10MG BASE A202244 002 Dec 31, 2012
AB AUROBINDO PHARMA LTD EQ 5MG BASE A202490 001 Dec 31, 2012
AB EQ 10MG BASE A202490 002 Dec 31, 2012
AB CIPLA LTD EQ 5MG BASE A077526 001 Mar 26, 2013
AB EQ 10MG BASE A077526 002 Mar 26, 2013
AB EMCURE PHARMS LTD EQ 5MG BASE A204090 001 Nov 26, 2013
AB EQ 10MG BASE A204090 002 Nov 26, 2013
AB GLENMARK GENERICS EQ 5MG BASE A201967 001 Dec 31, 2012
AB EQ 10MG BASE A201967 002 Dec 31, 2012
AB INVAGEN PHARMS EQ 5MG BASE A204339 001 Jul 01, 2013
AB EQ 10MG BASE A204339 002 Jul 01, 2013
AB MYLAN PHARMS INC EQ 5MG BASE A201993 001 Dec 31, 2012
AB EQ 10MG BASE A201993 002 Dec 31, 2012
AB NATCO PHARMA LTD EQ 5MG BASE A200482 001 Dec 31, 2012
AB EQ 10MG BASE A200482 002 Dec 31, 2012
AB SANDOZ EQ 5MG BASE A079230 001 Dec 31, 2012
AB EQ 10MG BASE A079230 002 Dec 31, 2012
AB SUN PHARMA GLOBAL EQ 5MG BASE A202047 001 Dec 31, 2012
AB EQ 10MG BASE A202047 002 Dec 31, 2012
AB TEVA PHARMS EQ 5MG BASE A077263 001 Dec 31, 2012
AB EQ 10MG BASE A077263 002 Dec 31, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-311( of 362)
RIZATRIPTAN BENZOATE
TABLET, ORALLY DISINTEGRATING;ORAL
MAXALT-MLT
AB MERCK EQ 5MG BASE N020865 001 Jun 29, 1998
AB + EQ 10MG BASE N020865 002 Jun 29, 1998
RIZATRIPTAN BENZOATE
AB APOTEX INC EQ 5MG BASE A202477 001 Jul 01, 2013
AB EQ 10MG BASE A202477 002 Jul 01, 2013
AB AUROBINDO PHARMA LTD EQ 5MG BASE A203062 001 Jul 01, 2013
AB EQ 10MG BASE A203062 002 Jul 01, 2013
AB GLENMARK GENERICS EQ 5MG BASE A201914 001 Jul 01, 2013
AB EQ 10MG BASE A201914 002 Jul 01, 2013
AB MYLAN PHARMS INC EQ 5MG BASE A078173 001 Dec 31, 2012
AB EQ 10MG BASE A078173 002 Dec 31, 2012
AB NATCO PHARMA LTD EQ 5MG BASE A203478 001 Jul 01, 2013
AB EQ 10MG BASE A203478 002 Jul 01, 2013
AB SANDOZ EQ 5MG BASE A078739 001 Jul 01, 2013
AB EQ 10MG BASE A078739 002 Jul 01, 2013
ROCURONIUM BROMIDE
INJECTABLE;INJECTION
ROCURONIUM BROMIDE
AP FRESENIUS KABI USA 50MG/5ML (10MG/ML) A078651 001 Dec 29, 2008
AP 100MG/10ML (10MG/ML) A078651 002 Dec 29, 2008
AP HOSPIRA 50MG/5ML (10MG/ML) A078519 001 Nov 26, 2008
AP 100MG/10ML (10MG/ML) A078519 002 Nov 26, 2008
AP MYLAN INSTITUTIONAL 50MG/5ML (10MG/ML) A079199 001 Nov 26, 2008
AP 100MG/10ML (10MG/ML) A079199 002 Nov 26, 2008
AP SAGENT STRIDES 50MG/5ML (10MG/ML) A091458 001 Jul 28, 2010
AP 100MG/10ML (10MG/ML) A091458 002 Jul 28, 2010
AP SANDOZ 50MG/5ML (10MG/ML) A079195 001 Dec 05, 2008
AP 100MG/10ML (10MG/ML) A079195 002 Dec 05, 2008
AP TAMARANG 50MG/5ML (10MG/ML) A091115 001 Aug 27, 2012
AP 100MG/10ML (10MG/ML) A091115 002 Aug 27, 2012
AP TEVA PHARMS 50MG/5ML (10MG/ML) A078717 001 Nov 26, 2008
AP 100MG/10ML (10MG/ML) A078717 002 Nov 26, 2008
ZEMURON
AP + ORGANON USA INC 50MG/5ML (10MG/ML) N020214 001 Mar 17, 1994
AP + 100MG/10ML (10MG/ML) N020214 003 Mar 17, 1994
ROFLUMILAST
TABLET;ORAL
DALIRESP
+ FOREST RES INST INC 500MCG N022522 001 Feb 28, 2011
ROMIDEPSIN
POWDER;IV (INFUSION)
ISTODAX
+ CELGENE 10MG/VIAL N022393 001 Nov 05, 2009
ROPINIROLE HYDROCHLORIDE
TABLET;ORAL
REQUIP
AB + GLAXOSMITHKLINE LLC EQ 0.25MG BASE N020658 001 Sep 19, 1997
AB EQ 0.5MG BASE N020658 002 Sep 19, 1997
AB EQ 1MG BASE N020658 003 Sep 19, 1997
AB EQ 2MG BASE N020658 004 Sep 19, 1997
AB EQ 3MG BASE N020658 006 Jan 27, 1999
AB EQ 4MG BASE N020658 007 Jan 27, 1999
AB EQ 5MG BASE N020658 005 Sep 19, 1997
ROPINIROLE HYDROCHLORIDE
AB ALEMBIC LTD EQ 0.25MG BASE A090429 001 Mar 24, 2010
AB EQ 0.5MG BASE A090429 002 Mar 24, 2010
AB EQ 1MG BASE A090429 003 Mar 24, 2010
AB EQ 2MG BASE A090429 004 Mar 24, 2010
AB EQ 3MG BASE A090429 005 Mar 24, 2010
AB EQ 4MG BASE A090429 006 Mar 24, 2010
AB EQ 5MG BASE A090429 007 Mar 24, 2010
AB APOTEX EQ 0.25MG BASE A079165 001 Feb 07, 2012
AB EQ 0.5MG BASE A079165 002 Feb 07, 2012
AB EQ 1MG BASE A079165 003 Feb 07, 2012
AB EQ 2MG BASE A079165 004 Feb 07, 2012
AB EQ 3MG BASE A079165 005 Feb 07, 2012
AB EQ 4MG BASE A079165 006 Feb 07, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-312( of 362)
ROPINIROLE HYDROCHLORIDE
TABLET;ORAL
ROPINIROLE HYDROCHLORIDE
AB EQ 5MG BASE A079165 007 Feb 07, 2012
AB GLENMARK GENERICS EQ 0.25MG BASE A090135 001 Feb 25, 2010
AB EQ 0.5MG BASE A090135 002 Feb 25, 2010
AB EQ 1MG BASE A090135 003 Feb 25, 2010
AB EQ 2MG BASE A090135 004 Feb 25, 2010
AB EQ 3MG BASE A090135 005 Feb 25, 2010
AB EQ 4MG BASE A090135 006 Feb 25, 2010
AB EQ 5MG BASE A090135 007 Feb 25, 2010
AB MYLAN EQ 0.25MG BASE A078881 001 May 05, 2008
AB EQ 0.5MG BASE A078881 002 May 05, 2008
AB EQ 1MG BASE A078881 003 May 05, 2008
AB EQ 2MG BASE A078881 004 May 05, 2008
AB EQ 3MG BASE A078881 005 May 05, 2008
AB EQ 4MG BASE A078881 006 May 05, 2008
AB EQ 5MG BASE A078881 007 May 19, 2008
AB ORCHID HLTHCARE EQ 0.25MG BASE A079229 001 Nov 28, 2012
AB EQ 0.5MG BASE A079229 002 Nov 28, 2012
AB EQ 1MG BASE A079229 003 Nov 28, 2012
AB EQ 2MG BASE A079229 004 Nov 28, 2012
AB EQ 3MG BASE A079229 005 Nov 28, 2012
AB EQ 4MG BASE A079229 006 Nov 28, 2012
AB EQ 5MG BASE A079229 007 Nov 28, 2012
AB PRINSTON INC EQ 0.25MG BASE A078110 001 May 05, 2008
AB EQ 0.5MG BASE A078110 002 May 05, 2008
AB EQ 1MG BASE A078110 003 May 05, 2008
AB EQ 2MG BASE A078110 004 May 05, 2008
AB EQ 3MG BASE A078110 005 May 05, 2008
AB EQ 4MG BASE A078110 006 May 05, 2008
AB EQ 5MG BASE A078110 007 Jul 11, 2008
AB ROXANE EQ 0.25MG BASE A077852 001 May 05, 2008
AB EQ 0.5MG BASE A077852 002 May 05, 2008
AB EQ 1MG BASE A077852 003 May 05, 2008
AB EQ 2MG BASE A077852 004 May 05, 2008
AB EQ 3MG BASE A077852 005 May 05, 2008
AB EQ 4MG BASE A077852 006 May 05, 2008
AB EQ 5MG BASE A077852 007 May 19, 2008
AB TEVA EQ 0.25MG BASE A077460 001 May 05, 2008
AB EQ 0.5MG BASE A077460 002 May 05, 2008
AB EQ 1MG BASE A077460 003 May 05, 2008
AB EQ 2MG BASE A077460 004 May 05, 2008
AB EQ 3MG BASE A077460 005 May 05, 2008
AB EQ 4MG BASE A077460 006 May 05, 2008
AB EQ 5MG BASE A077460 007 May 19, 2008
AB WOCKHARDT EQ 0.25MG BASE A079050 001 May 29, 2008
AB EQ 0.5MG BASE A079050 002 May 29, 2008
AB EQ 1MG BASE A079050 003 May 29, 2008
AB EQ 2MG BASE A079050 004 May 29, 2008
AB EQ 3MG BASE A079050 005 May 29, 2008
AB EQ 4MG BASE A079050 006 May 29, 2008
AB EQ 5MG BASE A079050 007 May 29, 2008
AB ZYDUS PHARMS USA INC EQ 0.25MG BASE A090411 001 Jun 01, 2009
AB EQ 0.5MG BASE A090411 002 Jun 01, 2009
AB EQ 1MG BASE A090411 003 Jun 01, 2009
AB EQ 2MG BASE A090411 004 Jun 01, 2009
AB EQ 3MG BASE A090411 005 Jun 01, 2009
AB EQ 4MG BASE A090411 006 Jun 01, 2009
AB EQ 5MG BASE A090411 007 Jun 01, 2009
TABLET, EXTENDED RELEASE;ORAL
REQUIP XL
AB + GLAXOSMITHKLINE LLC EQ 2MG BASE N022008 001 Jun 13, 2008
AB EQ 4MG BASE N022008 003 Jun 13, 2008
AB EQ 6MG BASE N022008 006 Apr 10, 2009
AB EQ 8MG BASE N022008 004 Jun 13, 2008
AB EQ 12MG BASE N022008 005 Oct 31, 2008
ROPINIROLE HYDROCHLORIDE
AB ACTAVIS ELIZABETH EQ 2MG BASE A090869 001 May 17, 2012
AB EQ 4MG BASE A090869 002 May 17, 2012
AB EQ 6MG BASE A090869 003 May 17, 2012
AB EQ 8MG BASE A090869 004 May 17, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
ROPINIROLE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ROPINIROLE HYDROCHLORIDE
AB
AB ALEMBIC LTD
AB
AB
AB
AB
AB DR REDDYS LABS LTD
AB
AB
AB
AB
AB MYLAN PHARMS INC
AB
AB
AB
AB
AB SANDOZ INC
AB
AB
AB
AB
AB WATSON LABS INC
AB
AB
AB
AB
AB WOCKHARDT LTD
AB
AB
AB
AB
MYLAN PHARMS INC
ROPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
NAROPIN
FRESENIUS KABI USA
+
ROSIGLITAZONE MALEATE
TABLET;ORAL
AVANDIA
AB SB PHARMCO
AB
AB +
ROSIGLITAZONE MALEATE
AB TEVA
AB
AB
ROSUVASTATIN CALCIUM
TABLET;ORAL
CRESTOR
IPR
+
ROTIGOTINE
EQ 12MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 6MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 6MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 6MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 6MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 6MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 6MG BASE
EQ 8MG BASE
EQ 12MG BASE
EQ 3MG BASE
2MG/ML
5MG/ML
7.5MG/ML
10MG/ML
EQ 2MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 8MG BASE
5MG
10MG
20MG
40MG
FILM, EXTENDED RELEASE;TRANSDERMAL
NEUPRO
UCB INC 1MG/24HR
+ 2MG/24HR
3MG/24HR
4MG/24HR
6MG/24HR
8MG/24HR
3-313( of 362)
A090869 005 May 17, 2012
A202786 001 Apr 22, 2013
A202786 002 Apr 22, 2013
A202786 003 Apr 22, 2013
A202786 004 Apr 22, 2013
A202786 005 Apr 22, 2013
A201576 001 Jun 06, 2012
A201576 002 Jun 06, 2012
A201576 003 Jun 06, 2012
A201576 004 Jun 06, 2012
A201576 005 Jun 06, 2012
A200462 001 Oct 15, 2012
A200462 003 Oct 15, 2012
A200462 004 Oct 15, 2012
A200462 005 Oct 15, 2012
A200462 006 Oct 15, 2012
A201047 001 Jun 06, 2012
A201047 003 Jun 06, 2012
A201047 004 Jun 06, 2012
A201047 005 Jun 06, 2012
A201047 006 Jun 06, 2012
A200431 001 Jun 06, 2012
A200431 002 Jun 06, 2012
A200431 003 Jun 06, 2012
A200431 004 Jun 06, 2012
A200431 005 Jun 06, 2012
A091395 001 Aug 27, 2012
A091395 002 Aug 27, 2012
A091395 003 Aug 27, 2012
A091395 004 Aug 27, 2012
A091395 005 Aug 27, 2012
A200462 002 Oct 15, 2012
N020533 001 Sep 24, 1996
N020533 003 Sep 24, 1996
N020533 004 Sep 24, 1996
N020533 005 Sep 24, 1996
N021071 002 May 25, 1999
N021071 003 May 25, 1999
N021071 004 May 25, 1999
A076747 001 Jan 25, 2013
A076747 002 Jan 25, 2013
A076747 003 Jan 25, 2013
N021366 002 Aug 12, 2003
N021366 003 Aug 12, 2003
N021366 004 Aug 12, 2003
N021366 005 Aug 12, 2003
N021829 004 Apr 02, 2012
N021829 001 May 09, 2007
N021829 005 Apr 02, 2012
N021829 002 May 09, 2007
N021829 003 May 09, 2007
N021829 006 Apr 02, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
RUBIDIUM CHLORIDE RB-82
INJECTABLE;INJECTION
CARDIOGEN-82
BRACCO
RUFINAMIDE
SUSPENSION;ORAL
BANZEL
+ EISAI INC
TABLET;ORAL
BANZEL
EISAI INC
+
RUXOLITINIB PHOSPHATE
TABLET;ORAL
JAKAFI
INCYTE CORP
+
SACROSIDASE
SOLUTION;ORAL
SUCRAID
+ QOL MEDCL
SAFFLOWER OIL; SOYBEAN OIL
INJECTABLE;INJECTION
LIPOSYN II 10%
+ HOSPIRA
LIPOSYN II 20%
+ HOSPIRA
PRESCRIPTION DRUG PRODUCT LIST
N/A
40MG/ML
200MG
400MG
EQ 5MG BASE
EQ 10MG BASE
EQ 15MG BASE
EQ 20MG BASE
EQ 25MG BASE
8,500 IU/ML
5%;5% (5GM/100ML)
10%;10% (10GM/100ML)
SALMETEROL XINAFOATE
POWDER;INHALATION
SEREVENT
+ GLAXO GRP LTD EQ 0.05MG BASE/INH
SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
INJECTABLE;INJECTION
QUADRAMET
+ LANTHEUS MEDICAL
SAPROPTERIN DIHYDROCHLORIDE
POWDER;ORAL
KUVAN
+ BIOMARIN PHARM
TABLET;ORAL
KUVAN
+ BIOMARIN PHARM
SAQUINAVIR MESYLATE
CAPSULE;ORAL
INVIRASE
+ HOFFMANN LA ROCHE
TABLET;ORAL
INVIRASE
+ HOFFMAN LA ROCHE
SAXAGLIPTIN HYDROCHLORIDE
TABLET;ORAL
ONGLYZA
BRISTOL MYERS SQUIBB
+
SCOPOLAMINE
50mCi/ML
100MG/PACKET
100MG
EQ 200MG BASE
EQ 500MG BASE
EQ 2.5MG BASE
EQ 5MG BASE
FILM, EXTENDED RELEASE;TRANSDERMAL
TRANSDERM SCOP
+ NOVARTIS 1MG/72HR
3-314( of 362)
N019414 001 Dec 29, 1989
N201367 001 Mar 03, 2011
N021911 002 Nov 14, 2008
N021911 003 Nov 14, 2008
N202192 001 Nov 16, 2011
N202192 002 Nov 16, 2011
N202192 003 Nov 16, 2011
N202192 004 Nov 16, 2011
N202192 005 Nov 16, 2011
N020772 001 Apr 09, 1998
N018997 001 Aug 27, 1984
N018991 001 Aug 27, 1984
N020692 001 Sep 19, 1997
N020570 001 Mar 28, 1997
N205065 001 Dec 19, 2013
N022181 001 Dec 13, 2007
N020628 001 Dec 06, 1995
N021785 001 Dec 17, 2004
N022350 001 Jul 31, 2009
N022350 002 Jul 31, 2009
N017874 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-315( of 362)
SECOBARBITAL SODIUM
CAPSULE;ORAL
SECONAL SODIUM
+ MARATHON PHARMS 50MG A086101 001 Oct 03, 1983
+ 100MG A086101 002 Oct 03, 1983
SECRETIN SYNTHETIC HUMAN
FOR SOLUTION;INTRAVENOUS
CHIRHOSTIM
+ CHIRHOCLIN 16MCG/VIAL N021256 001 Apr 09, 2004
40MCG/VIAL N021256 002 Jun 21, 2007
SELEGILINE
FILM, EXTENDED RELEASE;TRANSDERMAL
EMSAM
+ SOMERSET 6MG/24HR N021336 001 Feb 27, 2006
9MG/24HR N021336 002 Feb 27, 2006
12MG/24HR N021336 003 Feb 27, 2006
SELEGILINE HYDROCHLORIDE
CAPSULE;ORAL
ELDEPRYL
AB + SOMERSET 5MG N020647 001 May 15, 1996
SELEGILINE HYDROCHLORIDE
AB APOTEX 5MG A075321 001 Dec 04, 1998
AB DAVA PHARMS INC 5MG A075352 001 Nov 30, 1998
TABLET;ORAL
SELEGILINE HYDROCHLORIDE
AB + APOTEX INC 5MG A074871 001 Jun 06, 1997
AB MYLAN 5MG A074866 001 Nov 26, 1997
AB STASON 5MG A074912 001 Apr 30, 1998
TABLET, ORALLY DISINTEGRATING;ORAL
ZELAPAR
+ VALEANT PHARM INTL 1.25MG N021479 001 Jun 14, 2006
SELENIUM SULFIDE
LOTION/SHAMPOO;TOPICAL
SELENIUM SULFIDE
AT PERRIGO NEW YORK 2.5% A089996 001 Jan 10, 1991
AT WOCKHARDT 2.5% A088228 001 Sep 01, 1983
SELSUN
AT + CHATTEM 2.5% N007936 001
SERTACONAZOLE NITRATE
CREAM;TOPICAL
ERTACZO
+ VALEANT LUXEMBOURG 2% N021385 001 Dec 10, 2003
SERTRALINE HYDROCHLORIDE
CONCENTRATE;ORAL
SERTRALINE HYDROCHLORIDE
AA AUROBINDO PHARMA EQ 20MG BASE/ML A078861 001 Oct 31, 2008
ZOLOFT
AA + PFIZER EQ 20MG BASE/ML N020990 001 Dec 07, 1999
TABLET;ORAL
SERTRALINE HYDROCHLORIDE
AB APOTEX INC EQ 25MG BASE A076882 001 Feb 06, 2007
AB EQ 50MG BASE A076882 002 Feb 06, 2007
AB EQ 100MG BASE A076882 003 Feb 06, 2007
AB AUROBINDO PHARMA EQ 25MG BASE A077206 001 Feb 06, 2007
AB EQ 50MG BASE A077206 002 Feb 06, 2007
AB EQ 100MG BASE A077206 003 Feb 06, 2007
AB AUSTARPHARMA LLC EQ 25MG BASE A078677 001 Mar 04, 2009
AB EQ 50MG BASE A078677 002 Mar 04, 2009
AB EQ 100MG BASE A078677 003 Mar 04, 2009
AB HIKMA PHARMS EQ 25MG BASE A077864 001 Aug 10, 2009
AB EQ 50MG BASE A077864 002 Aug 10, 2009
AB EQ 100MG BASE A077864 003 Aug 10, 2009
AB INVAGEN PHARMS EQ 25MG BASE A077397 001 Feb 06, 2007
AB EQ 50MG BASE A077397 002 Feb 06, 2007
AB EQ 100MG BASE A077397 003 Feb 06, 2007
AB LUPIN EQ 25MG BASE A077670 001 Feb 06, 2007
AB EQ 50MG BASE A077670 002 Feb 06, 2007
AB EQ 100MG BASE A077670 003 Feb 06, 2007
AB MYLAN EQ 25MG BASE A076671 001 Feb 06, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
SERTRALINE HYDROCHLORIDE
TABLET;ORAL
SERTRALINE HYDROCHLORIDE
AB
AB
AB MYLAN PHARMS INC
AB
AB
AB PROSAM LABS
AB
AB
AB RANBAXY
AB
AB
AB SUN PHARM INDS (IN)
AB
AB
AB TEVA
AB
AB
AB TORRENT PHARMS
AB
AB
AB WATSON LABS
AB
AB
AB WOCKHARDT
AB
AB
AB ZYDUS PHARMS USA
AB
AB
ZOLOFT
AB PFIZER
AB
AB +
SERTRALINE HYDROCHLORIDE
RANBAXY
SEVELAMER CARBONATE
FOR SUSPENSION;ORAL
RENVELA
+ GENZYME
TABLET;ORAL
RENVELA
+ GENZYME
SEVELAMER HYDROCHLORIDE
TABLET;ORAL
RENAGEL
GENZYME
+
SEVOFLURANE
LIQUID;INHALATION
SEVOFLURANE
AN BAXTER HLTHCARE
AN HALOCARBON PRODS
SOJOURN
AN PIRAMAL CRITICAL
ULTANE
AN + ABBVIE
SILDENAFIL CITRATE
FOR SUSPENSION;ORAL
REVATIO
+ PFIZER
SOLUTION;INTRAVENOUS
REVATIO
+ PFIZER
EQ 50MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 200MG BASE
2.4GM/PACKET
800MG/PACKET
800MG
400MG
800MG
100%
100%
100%
100%
EQ 10MG BASE/ML
EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
3-316( of 362)
A076671 002 Feb 06, 2007
A076671 003 Feb 06, 2007
A078626 001 Jan 31, 2008
A078626 002 Jan 31, 2008
A078626 003 Jan 31, 2008
A078175 001 Jul 21, 2010
A078175 002 Jul 21, 2010
A078175 003 Jul 21, 2010
A077977 001 Feb 06, 2007
A077977 002 Feb 06, 2007
A077977 003 Feb 06, 2007
A078108 001 Feb 06, 2007
A078108 002 Feb 06, 2007
A078108 003 Feb 06, 2007
A076465 001 Aug 11, 2006
A076465 002 Aug 11, 2006
A076465 003 Aug 11, 2006
A077765 001 Feb 06, 2007
A077765 002 Feb 06, 2007
A077765 003 Feb 06, 2007
A077663 001 Feb 06, 2007
A077663 002 Feb 06, 2007
A077663 003 Feb 06, 2007
A078403 001 Jan 08, 2008
A078403 002 Jan 08, 2008
A078403 003 Jan 08, 2008
A077106 001 Feb 06, 2007
A077106 002 Feb 06, 2007
A077106 003 Feb 06, 2007
N019839 005 Mar 06, 1996
N019839 001 Dec 30, 1991
N019839 002 Dec 30, 1991
A077977 004 Feb 06, 2007
A077977 005 Feb 06, 2007
N022318 002 Feb 18, 2009
N022318 001 Aug 12, 2009
N022127 001 Oct 19, 2007
N021179 001 Jul 12, 2000
N021179 002 Jul 12, 2000
A075895 001 Jul 02, 2002
A078650 001 Nov 19, 2007
A077867 001 May 02, 2007
N020478 001 Jun 07, 1995
N203109 001 Aug 30, 2012
N022473 001 Nov 18, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-317( of 362)
SILDENAFIL CITRATE
TABLET;ORAL
REVATIO
AB + PFIZER EQ 20MG BASE N021845 001 Jun 03, 2005
SILDENAFIL CITRATE
AB ACTAVIS GRP PTC EQ 20MG BASE A200149 001 Feb 25, 2013
AB AMNEAL PHARMS EQ 20MG BASE A202025 001 Feb 28, 2013
AB APOTEX CORP EQ 20MG BASE A091379 001 Nov 06, 2012
AB DR REDDYS LABS LTD EQ 20MG BASE A202598 001 Nov 06, 2012
AB MACLEODS PHARMS LTD EQ 20MG BASE A203814 001 Dec 17, 2013
AB MYLAN PHARMS INC EQ 20MG BASE A201150 001 Nov 09, 2012
AB TEVA PHARMS EQ 20MG BASE A078380 001 Jan 07, 2013
AB TORRENT PHARMS LTD EQ 20MG BASE A091479 001 Nov 06, 2012
AB WATSON LABS INC EQ 20MG BASE A202503 001 Nov 06, 2012
VIAGRA
PFIZER IRELAND EQ 25MG BASE N020895 001 Mar 27, 1998
EQ 50MG BASE N020895 002 Mar 27, 1998
+ EQ 100MG BASE N020895 003 Mar 27, 1998
SILODOSIN
CAPSULE;ORAL
RAPAFLO
+ WATSON LABS 4MG N022206 001 Oct 08, 2008
8MG N022206 002 Oct 08, 2008
SILVER SULFADIAZINE
CREAM;TOPICAL
SILVADENE
AB + KING PHARMS 1% N017381 001
SSD
AB DR REDDYS LA 1% N018578 001 Feb 25, 1982
THERMAZENE
AB THEPHARMANETWORK LLC 1% N018810 001 Dec 23, 1985
SSD AF
BX DR REDDYS LA 1% N018578 003 Jul 11, 1990
SIMEPREVIR
CAPSULE;ORAL
OLYSIO
+ JANSSEN RES AND DEV 150MG N205123 001 Nov 22, 2013
SIMVASTATIN
TABLET;ORAL
SIMVASTATIN
AB ACCORD HLTHCARE 10MG A078155 002 Feb 26, 2008
AB 20MG A078155 003 Feb 26, 2008
AB 40MG A078155 004 Feb 26, 2008
AB 80MG A078155 001 Feb 26, 2008
AB AUROBINDO PHARMA 5MG A077691 001 Dec 20, 2006
AB 10MG A077691 002 Dec 20, 2006
AB 20MG A077691 003 Dec 20, 2006
AB 40MG A077691 004 Dec 20, 2006
AB 80MG A077691 005 Dec 20, 2006
AB BLU CARIBE 5MG A078034 001 Dec 20, 2006
AB 10MG A078034 002 Dec 20, 2006
AB 20MG A078034 003 Dec 20, 2006
AB 40MG A078034 004 Dec 20, 2006
AB 80MG A078034 005 Dec 20, 2006
AB DR REDDYS LABS INC 5MG A077752 005 Jan 23, 2008
AB 10MG A077752 001 Dec 20, 2006
AB 20MG A077752 002 Dec 20, 2006
AB 40MG A077752 003 Dec 20, 2006
AB 80MG A077752 004 Dec 20, 2006
AB IVAX SUB TEVA PHARMS 5MG A076052 001 Jun 23, 2006
AB 10MG A076052 002 Jun 23, 2006
AB 20MG A076052 003 Jun 23, 2006
AB 40MG A076052 004 Jun 23, 2006
AB 80MG A076052 005 Dec 20, 2006
AB LUPIN 5MG A078103 005 Apr 14, 2009
AB 10MG A078103 001 May 11, 2007
AB 20MG A078103 002 May 11, 2007
AB 40MG A078103 003 May 11, 2007
AB 80MG A078103 004 May 11, 2007
AB MICRO LABS LTD 5MG A090383 001 Sep 16, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
SIMVASTATIN
TABLET;ORAL
SIMVASTATIN
AB 10MG
AB 20MG
AB 40MG
AB 80MG
AB MYLAN PHARMS INC 5MG
AB 10MG
AB 20MG
AB 40MG
AB 80MG
AB PROSAM LABS 5MG
AB 10MG
AB 20MG
AB 40MG
AB 80MG
AB RANBAXY 5MG
AB 10MG
AB 20MG
AB 40MG
AB 80MG
AB WATSON LABS 5MG
AB 10MG
AB 20MG
AB 40MG
AB 80MG
AB ZYDUS PHARMS USA 5MG
AB 10MG
AB 20MG
AB 40MG
AB 80MG
ZOCOR
AB MERCK 5MG
AB 10MG
AB 20MG
AB 40MG
AB + 80MG
SINCALIDE
INJECTABLE;INJECTION
KINEVAC
+ BRACCO 0.005MG/VIAL
SINECATECHINS
OINTMENT;TOPICAL
VEREGEN
+ MEDIGENE AG 15%
SIROLIMUS
SOLUTION;ORAL
RAPAMUNE
+ PF PRISM CV 1MG/ML
TABLET;ORAL
RAPAMUNE
AB PF PRISM CV 0.5MG
SIROLIMUS
AB ZYDUS PHARMS USA INC 0.5MG
RAPAMUNE
PF PRISM CV 1MG
+ 2MG
SITAGLIPTIN PHOSPHATE
TABLET;ORAL
JANUVIA
MERCK SHARP DOHME EQ 25MG BASE
EQ 50MG BASE
+ EQ 100MG BASE
3-318( of 362)
A090383 002 Sep 16, 2011
A090383 003 Sep 16, 2011
A090383 004 Sep 16, 2011
A090383 005 Sep 16, 2011
A090868 001 Jun 08, 2010
A090868 002 Jun 08, 2010
A090868 003 Jun 08, 2010
A090868 004 Jun 08, 2010
A090868 005 Jun 08, 2010
A078735 001 Aug 30, 2010
A078735 002 Aug 30, 2010
A078735 003 Aug 30, 2010
A078735 004 Aug 30, 2010
A078735 005 Aug 30, 2010
A076285 001 Dec 20, 2006
A076285 002 Dec 20, 2006
A076285 003 Dec 20, 2006
A076285 004 Dec 20, 2006
A076285 005 Jun 23, 2006
A076685 001 Dec 20, 2006
A076685 002 Dec 20, 2006
A076685 003 Dec 20, 2006
A076685 004 Dec 20, 2006
A076685 005 Dec 20, 2006
A077837 001 Dec 20, 2006
A077837 002 Dec 20, 2006
A077837 003 Dec 20, 2006
A077837 004 Dec 20, 2006
A077837 005 Dec 20, 2006
N019766 001 Dec 23, 1991
N019766 002 Dec 23, 1991
N019766 003 Dec 23, 1991
N019766 004 Dec 23, 1991
N019766 005 Jul 10, 1998
N017697 001
N021902 001 Oct 31, 2006
N021083 001 Sep 15, 1999
N021110 004 Jan 25, 2010
A201676 003 Jan 08, 2014
N021110 001 Aug 25, 2000
N021110 002 Aug 22, 2002
N021995 001 Oct 16, 2006
N021995 002 Oct 16, 2006
N021995 003 Oct 16, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-319( of 362)
SODIUM ACETATE ANHYDROUS
INJECTABLE;INJECTION
SODIUM ACETATE IN PLASTIC CONTAINER
+ HOSPIRA 2MEQ/ML N018893 001 May 04, 1983
SODIUM BENZOATE; SODIUM PHENYLACETATE
SOLUTION;IV (INFUSION)
AMMONUL
+ UCYCLYD 10%;10% (5GM/50ML;5GM/50ML) N020645 001 Feb 17, 2005
SODIUM BICARBONATE
INJECTABLE;INJECTION
SODIUM BICARBONATE
+ HOSPIRA 0.9MEQ/ML A077394 001 Nov 09, 2005
+ 1MEQ/ML A077394 002 Nov 09, 2005
SODIUM CHLORIDE
INJECTABLE;INJECTION
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP FRESENIUS KABI USA 9MG/ML A088911 001 Feb 07, 1985
AP + HOSPIRA 9MG/ML N018800 001 Oct 29, 1982
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 450MG/100ML N019635 001 Mar 09, 1988
AP BAXTER HLTHCARE 450MG/100ML N018016 001
AP HOSPIRA 450MG/100ML N018090 001
AP 450MG/100ML N019759 001 Jun 08, 1988
SODIUM CHLORIDE 0.9%
AP HIKMA (MAPLE) 9MG/ML A201850 001 Jan 20, 2012
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP + B BRAUN 900MG/100ML N017464 001
AP + 900MG/100ML N019635 002 Mar 09, 1988
AP + BAXTER HLTHCARE 9MG/ML N016677 004 Oct 30, 1985
AP 9MG/ML N020178 002 Dec 07, 1992
AP + 900MG/100ML N016677 001
AP + 900MG/100ML N020178 001 Dec 07, 1992
AP + FRESENIUS KABI USA 9MG/ML A088912 001 Jan 10, 1985
AP FRESENIUS MEDCL 900MG/100ML A078177 001 Apr 12, 2007
AP HAEMONETICS 900MG/100ML A076316 001 Oct 27, 2004
AP + HOSPIRA 9MG/ML N018803 001 Oct 29, 1982
AP + 9MG/ML N019217 001 Jul 13, 1984
AP 9MG/ML N019465 002 Jul 15, 1985
AP + 900MG/100ML N016366 001
AP + 900MG/100ML N019465 001 Jul 15, 1985
AP + 900MG/100ML N019480 001 Sep 17, 1985
AP + TARO PHARMS IRELAND 9MG/ML A077407 001 Aug 11, 2006
SODIUM CHLORIDE 0.9%
MEDEFIL INC 18MG/2ML (9MG/ML) N202832 002 Jan 06, 2012
22.5MG/2.5ML (9MG/ML) N202832 003 Jan 06, 2012
27MG/3ML (9MG/ML) N202832 004 Jan 06, 2012
45MG/5ML (9MG/ML) N202832 005 Jan 06, 2012
90MG/10ML (9MG/ML) N202832 006 Jan 06, 2012
SODIUM CHLORIDE 0.9%
HIKMA MAPLE 9MG/ML A201833 001 Sep 24, 2013
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
+ MALLINCKRODT 45MG/50ML (9MG/ML) N021569 001 Jul 27, 2006
112.5MG/125ML (9MG/ML) N021569 002 Jul 27, 2006
MEDEFIL INC 9MG/ML (9MG/ML) N202832 001 Jan 06, 2012
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
BAXTER HLTHCARE 3GM/100ML N019022 001 Nov 01, 1983
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML N019022 002 Nov 01, 1983
SODIUM CHLORIDE IN PLASTIC CONTAINER
HOSPIRA 2.5MEQ/ML N018897 001 Jul 20, 1984
SOLUTION;IRRIGATION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AT B BRAUN 900MG/100ML N016733 001
AT BAXTER HLTHCARE 900MG/100ML N017427 001
AT 900MG/100ML N017867 001
AT HOSPIRA 900MG/100ML N017514 001
AT 900MG/100ML N018314 001
SOLUTION FOR SLUSH;IRRIGATION
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER
BAXTER HLTHCARE 900MG/100ML N019319 002 May 17, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-320( of 362)
SODIUM FERRIC GLUCONATE COMPLEX
INJECTABLE;INJECTION
FERRLECIT
AB + SANOFI AVENTIS US 62.5MG/5ML N020955 001 Feb 18, 1999
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
AB HIKMA PHARMS 62.5MG/5ML A078215 001 Mar 31, 2011
SODIUM FLUORIDE F-18
INJECTABLE;INTRAVENOUS
SODIUM FLUORIDE F-18
AP + HOUSTON CYCLOTRON 10-200mCi/ML A203544 001 Dec 26, 2012
AP UNIV TX MD ANDERSON 10-200mCi/ML A203247 001 Dec 23, 2013
+ MCPRF 10-91.5MCI/ML A203605 001 Jun 28, 2013
SODIUM IODIDE I-123
CAPSULE;ORAL
SODIUM IODIDE I 123
AA + CARDINAL HLTH 414 100uCi N018671 001 May 27, 1982
AA + 200uCi N018671 002 May 27, 1982
AA MALLINCKRODT 100uCi A071909 001 Feb 28, 1989
AA 200uCi A071910 001 Feb 28, 1989
SODIUM IODIDE I-131
CAPSULE;ORAL
SODIUM IODIDE I 131
+ MALLINCKRODT 0.8-100mCi N016517 001
SODIUM IODIDE I-131
JUBILANT DRAXIMAGE 9-100mCi N021305 006 May 19, 2005
SOLUTION;ORAL
HICON
+ JUBILANT DRAXIMAGE 250-1000mCi N021305 007 Dec 05, 2011
SODIUM IODIDE I 131
+ MALLINCKRODT 3.5-150mCi/VIAL N016515 001
SODIUM LACTATE
INJECTABLE;INJECTION
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 1.87GM/100ML N016692 001
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER
AP B BRAUN 1.87GM/100ML N020004 001 Apr 21, 1992
SODIUM LACTATE IN PLASTIC CONTAINER
+ HOSPIRA 5MEQ/ML N018947 001 Sep 05, 1984
SODIUM NITRITE
SOLUTION;INTRAVENOUS
SODIUM NITRITE
+ HOPE PHARMS 300MG/10ML (30MG/ML) N203922 001 Feb 14, 2012
SODIUM NITRITE; SODIUM THIOSULFATE
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS
NITHIODOTE
+ HOPE PHARMS 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML N201444 001 Jan 14, 2011
(250MG/ML)
SODIUM NITROPRUSSIDE
INJECTABLE;INJECTION
NITROPRESS
+ HOSPIRA 25MG/ML A071961 001 Aug 01, 1988
SODIUM OXYBATE
SOLUTION;ORAL
XYREM
+ JAZZ PHARMS 500MG/ML N021196 001 Jul 17, 2002
SODIUM PHENYLBUTYRATE
POWDER;ORAL
BUPHENYL
AB + HYPERION THERAPS INC 3GM/TEASPOONFUL N020573 001 Apr 30, 1996
SODIUM PHENYLBUTYRATE
AB SIGMAPHARM LABS LLC 3GM/TEASPOONFUL A202819 001 Mar 22, 2013
TABLET;ORAL
BUPHENYL
AB + HYPERION THERAPS INC 500MG N020572 001 May 13, 1996
SODIUM PHENYLBUTYRATE
AB AMPOLGEN 500MG A090910 001 Nov 18, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-321( of 362)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
TABLET;ORAL
OSMOPREP
+ SALIX PHARMS 0.398GM;1.102GM N021892 001 Mar 16, 2006
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
INJECTABLE;INJECTION
SODIUM PHOSPHATES IN PLASTIC CONTAINER
+ HOSPIRA 142MG/ML;276MG/ML N018892 001 May 10, 1983
SODIUM POLYSTYRENE SULFONATE
POWDER;ORAL, RECTAL
KALEXATE
AA KVK TECH 454GM/BOT A040905 001 Mar 30, 2009
KAYEXALATE
AA + COVIS PHARMA SARL 453.6GM/BOT N011287 001
KIONEX
AA PADDOCK LLC 454GM/BOT A040029 001 Feb 06, 1998
SODIUM POLYSTYRENE SULFONATE
AA CAROLINA MEDCL 454GM/BOT A089910 001 Jan 19, 1989
AA CEDAR PHARMS 453.6GM/BOT A090313 001 Dec 21, 2011
SUSPENSION;ORAL, RECTAL
KIONEX
AA PADDOCK LLC 15GM/60ML A040028 001 Sep 17, 2007
SODIUM POLYSTYRENE SULFONATE
AA PADDOCK LLC 15GM/60ML A090590 001 May 13, 2011
AA ROXANE 15GM/60ML A089049 001 Nov 17, 1986
SPS
AA + CAROLINA MEDCL 15GM/60ML A087859 001 Dec 08, 1982
SODIUM TETRADECYL SULFATE
INJECTABLE;INJECTION
SOTRADECOL
MYLAN INSTITUTIONAL 20MG/2ML (10MG/ML) A040541 001 Nov 12, 2004
+ 60MG/2ML (30MG/ML) A040541 002 Nov 12, 2004
SODIUM THIOSULFATE
SOLUTION;INTRAVENOUS
SODIUM THIOSULFATE
+ HOPE PHARMS 12.5GM/50ML (250MG/ML) N203923 001 Feb 14, 2012
SOFOSBUVIR
TABLET;ORAL
SOVALDI
+ GILEAD SCIENCES INC 400MG N204671 001 Dec 06, 2013
SOLIFENACIN SUCCINATE
TABLET;ORAL
VESICARE
ASTELLAS 5MG N021518 001 Nov 19, 2004
+ 10MG N021518 002 Nov 19, 2004
SOMATROPIN RECOMBINANT
INJECTABLE;INJECTION
GENOTROPIN
BX + PHARMACIA AND UPJOHN 5.8MG/VIAL N020280 006 Aug 24, 1995
GENOTROPIN PRESERVATIVE FREE
BX PHARMACIA AND UPJOHN 1.5MG/VIAL N020280 004 Aug 24, 1995
HUMATROPE
BX + LILLY 5MG/VIAL N019640 004 Mar 08, 1987
BX 6MG/VIAL N019640 005 Feb 04, 1999
NORDITROPIN FLEXPRO
BX NOVO NORDISK INC 5MG/1.5ML N021148 008 Mar 01, 2010
BX 10MG/1.5ML N021148 009 Mar 01, 2010
NUTROPIN
BX GENENTECH 5MG/VIAL N020168 001 Nov 17, 1993
OMNITROPE
BX SANDOZ 1.5MG/VIAL N021426 002 May 30, 2006
BX 5MG/1.5ML N021426 003 Jan 16, 2008
BX 5.8MG/VIAL N021426 001 May 30, 2006
BX 10MG/1.5ML N021426 004 Aug 25, 2008
SAIZEN
BX EMD SERONO 5MG/VIAL N019764 002 Oct 08, 1996
SEROSTIM
BX EMD SERONO 4MG/VIAL N020604 003 Jul 25, 1997
BX 5MG/VIAL N020604 002 Aug 23, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-322( of 362)
SOMATROPIN RECOMBINANT
INJECTABLE;INJECTION
SEROSTIM
BX 6MG/VIAL N020604 001 Aug 23, 1996
TEV-TROPIN
BX + FERRING 5MG/VIAL N019774 002 Jan 04, 2002
VALTROPIN
BX LG LIFE 5MG/VIAL N021905 001 Apr 19, 2007
GENOTROPIN
+ PHARMACIA AND UPJOHN 13.8MG/VIAL N020280 007 Oct 23, 1996
GENOTROPIN PRESERVATIVE FREE
PHARMACIA AND UPJOHN 0.2MG/VIAL N020280 001 Jan 27, 1998
0.4MG/VIAL N020280 002 Jan 27, 1998
0.6MG/VIAL N020280 003 Jan 27, 1998
0.8MG/VIAL N020280 005 Jan 27, 1998
1MG/VIAL N020280 008 Jan 27, 1998
1.2MG/VIAL N020280 009 Jan 27, 1998
1.4MG/VIAL N020280 010 Jan 27, 1998
1.6MG/VIAL N020280 011 Jan 27, 1998
1.8MG/VIAL N020280 012 Jan 27, 1998
+ 2MG/VIAL N020280 013 Jan 27, 1998
HUMATROPE
+ LILLY 12MG/VIAL N019640 006 Feb 04, 1999
+ 24MG/VIAL N019640 007 Feb 04, 1999
NORDITROPIN FLEXPRO
NOVO NORDISK INC 15MG/1.5ML N021148 010 Mar 01, 2010
NORDITROPIN NORDIFLEX
NOVO NORDISK INC 30MG/3ML N021148 007 Mar 10, 2009
NUTROPIN
+ GENENTECH 10MG/VIAL N020168 002 Nov 17, 1993
NUTROPIN AQ
+ GENENTECH 5MG/2ML (2.5MG/ML) N020522 003 Jan 03, 2008
+ 10MG/2ML (5MG/ML) N020522 001 Dec 29, 1995
+ 20MG/2ML (10MG/ML) N020522 004 Jan 03, 2008
NUTROPIN AQ PEN
+ GENENTECH 10MG/2ML (5MG/ML) N020522 002 Apr 22, 2002
SAIZEN
+ EMD SERONO 8.8MG/VIAL N019764 003 Aug 29, 2000
ZORBTIVE
+ EMD SERONO 8.8MG/VIAL N021597 004 Dec 01, 2003
SORAFENIB TOSYLATE
TABLET;ORAL
NEXAVAR
+ BAYER HLTHCARE EQ 200MG BASE N021923 001 Dec 20, 2005
SORBITOL
SOLUTION;IRRIGATION
SORBITOL 3% IN PLASTIC CONTAINER
BAXTER HLTHCARE 3GM/100ML N017863 001
SORBITOL 3.3% IN PLASTIC CONTAINER
B BRAUN 3.3GM/100ML N016741 001
SOTALOL HYDROCHLORIDE
SOLUTION;INTRAVENOUS
SOTALOL HYDROCHLORIDE
+ ACADEMIC PHARMS 150MG/10ML (15MG/ML) N022306 001 Jul 02, 2009
TABLET;ORAL
BETAPACE
AB1 BAYER HLTHCARE 80MG N019865 001 Oct 30, 1992
AB1 120MG N019865 005 Apr 20, 1994
AB1 + 160MG N019865 002 Oct 30, 1992
AB1 240MG N019865 003 Oct 30, 1992
SORINE
AB1 UPSHER SMITH 80MG A075500 001 Apr 27, 2001
AB1 120MG A075500 004 Apr 27, 2001
AB1 160MG A075500 002 Apr 27, 2001
AB1 240MG A075500 003 Apr 27, 2001
SOTALOL HYDROCHLORIDE
AB1 APOTEX INC 80MG A076140 001 Sep 26, 2002
AB1 120MG A076140 002 Sep 26, 2002
AB1 160MG A076140 003 Sep 26, 2002
AB1 240MG A076140 004 Sep 26, 2002
AB1 IMPAX PHARMS 80MG A075663 001 Nov 07, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-323( of 362)
SOTALOL HYDROCHLORIDE
TABLET;ORAL
SOTALOL HYDROCHLORIDE
AB1 120MG A075663 002 Nov 07, 2000
AB1 160MG A075663 003 Nov 07, 2000
AB1 240MG A075663 004 Nov 07, 2000
AB1 MYLAN 80MG A075237 001 May 01, 2000
AB1 80MG A075725 001 Dec 19, 2000
AB1 120MG A075237 002 May 01, 2000
AB1 120MG A075725 002 Dec 19, 2000
AB1 160MG A075237 003 May 01, 2000
AB1 160MG A075725 003 Dec 19, 2000
AB1 240MG A075237 004 May 01, 2000
AB1 240MG A075725 004 Dec 19, 2000
AB1 SANDOZ 80MG A075366 001 May 01, 2000
AB1 120MG A075366 002 May 01, 2000
AB1 160MG A075366 003 May 01, 2000
AB1 240MG A075366 004 May 01, 2000
AB1 TEVA 80MG A075429 001 May 01, 2000
AB1 120MG A075429 002 May 01, 2000
AB1 160MG A075429 003 May 01, 2000
AB1 240MG A075429 004 May 01, 2000
AB1 VINTAGE PHARMS 80MG A075563 001 Nov 07, 2003
AB1 120MG A075563 002 Nov 07, 2003
AB1 160MG A075563 003 Nov 07, 2003
AB1 240MG A075563 004 Nov 07, 2003
BETAPACE AF
AB2 BAYER HLTHCARE 80MG N021151 001 Feb 22, 2000
AB2 120MG N021151 002 Feb 22, 2000
AB2 + 160MG N021151 003 Feb 22, 2000
SOTALOL HYDROCHLORIDE
AB2 APOTEX 80MG A076214 001 Aug 27, 2003
AB2 120MG A076214 002 Aug 27, 2003
AB2 160MG A076214 003 Aug 27, 2003
AB2 EPIC PHARMA INC 80MG A077070 001 Nov 04, 2005
AB2 120MG A077070 002 Nov 04, 2005
AB2 160MG A077070 003 Nov 04, 2005
AB2 MYLAN 80MG A077616 001 Feb 07, 2007
AB2 120MG A077616 002 Feb 07, 2007
AB2 160MG A077616 003 Feb 07, 2007
AB2 TEVA 80MG A076883 001 Jul 26, 2004
AB2 120MG A076883 002 Jul 26, 2004
AB2 160MG A076883 003 Jul 26, 2004
SOYBEAN OIL
INJECTABLE;INJECTION
INTRALIPID 10%
AP + FRESENIUS 10% N017643 001
INTRALIPID 20%
AP + FRESENIUS 20% N018449 001
AP + 20% N020248 001 Aug 07, 1996
INTRALIPID 30%
AP + FRESENIUS 30% N019942 001 Dec 30, 1993
LIPOSYN III 10%
AP + HOSPIRA 10% N018969 001 Sep 24, 1984
LIPOSYN III 20%
AP + HOSPIRA 20% N018970 001 Sep 25, 1984
LIPOSYN III 30%
AP + HOSPIRA 30% N020181 001 Jan 13, 1998
NUTRILIPID 10%
AP + B BRAUN 10% N019531 001 May 28, 1993
NUTRILIPID 20%
AP + B BRAUN 20% N019531 002 May 28, 1993
SPINOSAD
SUSPENSION;TOPICAL
NATROBA
+ PARAPRO LLC 0.9% N022408 001 Jan 18, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-324( of 362)
SPIRONOLACTONE
TABLET;ORAL
ALDACTONE
AB GD SEARLE LLC 25MG N012151 009 Dec 30, 1983
AB 50MG N012151 008 Dec 30, 1982
AB + 100MG N012151 010 Dec 30, 1983
SPIRONOLACTONE
AB ACTAVIS ELIZABETH 25MG A040353 003 Mar 15, 2006
AB 50MG A040353 001 Jul 29, 1999
AB 100MG A040353 002 Jul 29, 1999
AB AMNEAL PHARMS 25MG A091426 001 Jun 08, 2010
AB 50MG A091426 002 Jun 08, 2010
AB 100MG A091426 003 Jun 08, 2010
AB MUTUAL PHARM 25MG A089424 001 Jul 23, 1986
AB 50MG A089424 002 Aug 11, 1999
AB 100MG A089424 003 Aug 11, 1999
AB MYLAN 25MG A040424 001 Aug 20, 2001
AB 50MG A040424 002 Aug 20, 2001
AB 100MG A040424 003 Aug 20, 2001
AB SANDOZ 25MG A086809 001
AB VINTAGE 25MG A040750 001 Aug 29, 2006
AB 50MG A040750 002 Aug 29, 2006
AB 100MG A040750 003 Aug 29, 2006
STAVUDINE
CAPSULE;ORAL
STAVUDINE
AB AUROBINDO PHARMA 15MG A077672 003 Dec 29, 2008
AB 20MG A077672 004 Dec 29, 2008
AB 30MG A077672 001 Dec 29, 2008
AB 40MG A077672 002 Dec 29, 2008
AB HETERO LABS LTD III 15MG A078957 001 Dec 29, 2008
AB 20MG A078957 002 Dec 29, 2008
AB 30MG A078957 003 Dec 29, 2008
AB 40MG A078957 004 Dec 29, 2008
AB MATRIX LABS LTD 30MG A078775 001 Jan 05, 2009
AB 40MG A078775 002 Jan 05, 2009
AB MYLAN 15MG A079069 001 Dec 29, 2008
AB 20MG A079069 002 Dec 29, 2008
AB 30MG A079069 003 Dec 29, 2008
AB 40MG A079069 004 Dec 29, 2008
ZERIT
AB BRISTOL MYERS SQUIBB 15MG N020412 002 Jun 24, 1994
AB 20MG N020412 003 Jun 24, 1994
AB 30MG N020412 004 Jun 24, 1994
AB + 40MG N020412 005 Jun 24, 1994
FOR SOLUTION;ORAL
STAVUDINE
AA AUROBINDO PHARMA 1MG/ML A077774 001 Dec 29, 2008
AA CIPLA LTD 1MG/ML A078030 001 Mar 20, 2009
ZERIT
AA + BRISTOL MYERS SQUIBB 1MG/ML N020413 001 Sep 06, 1996
STERILE WATER FOR INJECTION
LIQUID;N/A
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
AP + HOSPIRA 100% N018802 001 Oct 27, 1982
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
AP + B BRAUN 100% N019633 001 Feb 29, 1988
AP + BAXTER HLTHCARE 100% N018632 001 Jun 30, 1982
AP + 100% N018632 002 Apr 19, 1988
AP FRESENIUS KABI USA 100% A088400 001 Jan 16, 1984
AP + HOSPIRA 100% N018233 001
AP + 100% N018801 001 Oct 27, 1982
AP + 100% N019869 001 Dec 26, 1989
AP TARO PHARMS IRELAND 100% A077393 001 Aug 11, 2006
STERILE WATER FOR IRRIGATION
LIQUID;IRRIGATION
STERILE WATER
AT BAXTER HLTHCARE 100% N017428 001
STERILE WATER IN PLASTIC CONTAINER
AT B BRAUN 100% N016734 001
AT BAXTER HLTHCARE 100% N017866 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
STERILE WATER FOR IRRIGATION
LIQUID;IRRIGATION
STERILE WATER IN PLASTIC CONTAINER
AT HOSPIRA
AT
STREPTOMYCIN SULFATE
INJECTABLE;INJECTION
STREPTOMYCIN SULFATE
+ X GEN PHARMS
STREPTOZOCIN
INJECTABLE;INJECTION
ZANOSAR
+ TEVA PHARMS USA
STRONTIUM CHLORIDE SR-89
INJECTABLE;INJECTION
METASTRON
AP + GE HEALTHCARE
STRONTIUM CHLORIDE SR-89
AP BIO NUCLEONICS
SUCCIMER
CAPSULE;ORAL
CHEMET
+ RECORDATI RARE
SUCCINYLCHOLINE CHLORIDE
INJECTABLE;INJECTION
ANECTINE
AP + SANDOZ
QUELICIN
AP + HOSPIRA
QUELICIN PRESERVATIVE FREE
AP + HOSPIRA
+
SUCRALFATE
SUSPENSION;ORAL
CARAFATE
+ APTALIS PHARMA US
TABLET;ORAL
CARAFATE
AB + APTALIS PHARMA US
SUCRALFATE
AB NOSTRUM LABS
AB TEVA
SUCROFERRIC OXYHYDROXIDE
TABLET, CHEWABLE;ORAL
VELPHORO
+ VIFOR FRESENIUS
SUFENTANIL CITRATE
INJECTABLE;INJECTION
SUFENTA PRESERVATIVE FREE
AP + AKORN
SUFENTANIL CITRATE
AP HIKMA MAPLE
AP HOSPIRA
SULCONAZOLE NITRATE
CREAM;TOPICAL
EXELDERM
+ RANBAXY
SOLUTION;TOPICAL
EXELDERM
+ RANBAXY
SULFACETAMIDE SODIUM
LOTION;TOPICAL
KLARON
AB + VALEANT BERMUDA
SULFACETAMIDE SODIUM
AB FOUGERA PHARMS
AB PERRIGO CO TENNESSEE
100%
100%
EQ 1GM BASE/VIAL
1GM/VIAL
1mCi/ML
1mCi/ML
100MG
20MG/ML
20MG/ML
20MG/ML
100MG/ML
1GM/10ML
1GM
1GM
1GM
500MG
EQ 0.05MG BASE/ML
EQ 0.05MG BASE/ML
EQ 0.05MG BASE/ML
1%
1%
10%
10%
10%
3-325( of 362)
N017513 001
N018313 001
A064210 001 Jun 30, 1998
N050577 001 May 07, 1982
N020134 001 Jun 18, 1993
A075941 001 Jan 06, 2003
N019998 002 Jan 30, 1991
N008453 002
N008845 006
N008845 001
N008845 004
N019183 001
N018333 001
Dec 16, 1993
A074415 001 Jun 08, 1998
A070848 001 Mar 29, 1996
N205109 001 Nov 27, 2013
N019050 001 May 04, 1984
A074413 001 Dec 15, 1995
A074534 001 Dec 11, 1996
N018737 001 Feb 28, 1989
N018738 001 Aug 30, 1985
N019931 001 Dec 23, 1996
A077015 001 Nov 17, 2006
A078649 001 Mar 23, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-326( of 362)
SULFACETAMIDE SODIUM
LOTION;TOPICAL
SULFACETAMIDE SODIUM
AB TARO 10% A078668 001 May 20, 2009
OINTMENT;OPHTHALMIC
CETAMIDE
AT + ALCON 10% A080021 001
SULFACETAMIDE SODIUM
AT PERRIGO CO TENNESSEE 10% A080029 001
SOLUTION/DROPS;OPHTHALMIC
BLEPH-10
AT + ALLERGAN 10% A080028 001
SULFACETAMIDE SODIUM
AT ALCON PHARMS LTD 10% A089560 001 Oct 18, 1988
AT BAUSCH AND LOMB 10% A040066 001 Dec 28, 1994
SULFADIAZINE
TABLET;ORAL
SULFADIAZINE
+ SANDOZ 500MG A040091 001 Jul 29, 1994
SULFAMETHOXAZOLE; TRIMETHOPRIM
INJECTABLE;INJECTION
SULFAMETHOXAZOLE AND TRIMETHOPRIM
+ TEVA PHARMS USA 80MG/ML;16MG/ML A073303 001 Oct 31, 1991
SUSPENSION;ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM
AB AUROBINDO PHARMA 200MG/5ML;40MG/5ML A091348 001 Jun 08, 2010
AB + HI TECH PHARMA 200MG/5ML;40MG/5ML A074650 001 Dec 29, 1997
AB VINTAGE 200MG/5ML;40MG/5ML A077785 001 Jan 24, 2007
SULFATRIM PEDIATRIC
AB STI PHARMA LLC 200MG/5ML;40MG/5ML N018615 001 Jan 07, 1983
TABLET;ORAL
BACTRIM
AB MUTUAL PHARM 400MG;80MG N017377 001
BACTRIM DS
AB + MUTUAL PHARM 800MG;160MG N017377 002
SEPTRA
AB MONARCH PHARMS 400MG;80MG N017376 001
SEPTRA DS
AB MONARCH PHARMS 800MG;160MG N017376 002
SULFAMETHOXAZOLE AND TRIMETHOPRIM
AB AMNEAL PHARMS NY 400MG;80MG A076899 001 Jan 27, 2005
AB 800MG;160MG A076899 002 Jan 27, 2005
AB AUROBINDO PHARMA 400MG;80MG A090624 001 Feb 16, 2010
AB 800MG;160MG A090624 002 Feb 16, 2010
AB GLENMARK GENERICS 400MG;80MG A090828 002 Dec 22, 2010
AB 800MG;160MG A090828 001 Dec 22, 2010
AB MUTUAL PHARM 800MG;160MG A071017 001 Aug 25, 1986
AB VINTAGE 400MG;80MG A078060 002 Jan 25, 2007
AB 800MG;160MG A078060 001 Jan 25, 2007
AB VISTA PHARMS 400MG;80MG A076817 001 Oct 07, 2005
AB 800MG;160MG A076817 002 Oct 07, 2005
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
AB TEVA 800MG;160MG A070037 001 Jun 02, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH
AB TEVA PHARMS 400MG;80MG A070030 001 Jun 02, 1987
SULFANILAMIDE
CREAM;VAGINAL
AVC
+ MEDA PHARMS 15% N006530 003 Jan 27, 1987
SULFASALAZINE
SUSPENSION;ORAL
AZULFIDINE
+ PHARMACIA AND UPJOHN 250MG/5ML A086983 001
TABLET;ORAL
AZULFIDINE
AB + PHARMACIA AND UPJOHN 500MG N007073 001
SULFASALAZINE
AB VINTAGE PHARMS 500MG A040349 001 Jan 11, 2002
AB WATSON LABS 500MG A085828 001
AB 500MG A087197 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-327( of 362)
SULFASALAZINE
TABLET, DELAYED RELEASE;ORAL
AZULFIDINE EN-TABS
AB + PHARMACIA AND UPJOHN 500MG N007073 002 Apr 06, 1983
SULFASALAZINE
AB VINTAGE PHARMS 500MG A075339 001 Jan 11, 2002
SULINDAC
TABLET;ORAL
CLINORIL
AB + MERCK 200MG N017911 002
SULINDAC
AB EPIC PHARMA 150MG A072710 001 Mar 25, 1991
AB 200MG A072711 001 Mar 25, 1991
AB HERITAGE PHARMS INC 150MG A073262 002 Sep 06, 1991
AB 200MG A073262 001 Sep 06, 1991
AB MUTUAL PHARM 150MG A072050 001 Apr 17, 1991
AB 200MG A072051 001 Apr 17, 1991
AB MYLAN 150MG A073039 002 Jun 22, 1993
AB 200MG A073039 001 Jun 22, 1993
AB WATSON LABS 150MG A071891 001 Apr 03, 1990
AB 200MG A071795 001 Apr 03, 1990
SUMATRIPTAN
SPRAY;NASAL
IMITREX
+ GLAXOSMITHKLINE 5MG/SPRAY N020626 001 Aug 26, 1997
+ 20MG/SPRAY N020626 003 Aug 26, 1997
SUMATRIPTAN SUCCINATE
INJECTABLE;SUBCUTANEOUS
IMITREX STATDOSE
AB + GLAXOSMITHKLINE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) N020080 003 Dec 23, 1996
SUMATRIPTAN SUCCINATE
AB SUN PHARMA GLOBAL EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A090358 001 Jun 21, 2011
IMITREX
AP + GLAXOSMITHKLINE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) N020080 001 Dec 28, 1992
SUMATRIPTAN SUCCINATE
AP AUROBINDO PHARMA LTD EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A202758 001 Apr 23, 2013
AP BEDFORD EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A079123 001 Feb 06, 2009
AP FRESENIUS KABI USA EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A079242 001 Mar 02, 2009
AP HIKMA FARMACEUTICA EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A200183 001 Sep 16, 2013
AP INJECTALIA EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A090310 001 Aug 11, 2010
AP JHP PHARMS EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A077871 001 Jul 09, 2009
AP PAR PHARM EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A077332 001 Oct 09, 2009
AP SAGENT AGILA EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A090641 001 Jul 28, 2010
AP SAGENT STRIDES EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A090314 001 Jun 10, 2010
AP TEVA PHARMS USA EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A077907 001 Feb 06, 2009
AP WOCKHARDT EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A078593 001 Feb 06, 2009
ALSUMA
BX MERIDIAN MEDCL EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) N022377 001 Jun 29, 2010
SUMAVEL DOSEPRO
BX + ZOGENIX INC EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) N022239 001 Jul 15, 2009
IMITREX STATDOSE
+ GLAXOSMITHKLINE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) N020080 002 Feb 01, 2006
SYSTEM;IONTOPHORESIS
ZECUITY
+ NUPATHE EQ 6.5MG BASE/4HR N202278 001 Jan 17, 2013
TABLET;ORAL
IMITREX
AB GLAXOSMITHKLINE EQ 25MG BASE N020132 002 Jun 01, 1995
AB EQ 50MG BASE N020132 003 Jun 01, 1995
AB + EQ 100MG BASE N020132 001 Jun 01, 1995
SUMATRIPTAN SUCCINATE
AB APOTEX INC EQ 25MG BASE A200263 001 Jun 19, 2012
AB EQ 50MG BASE A200263 002 Jun 19, 2012
AB EQ 100MG BASE A200263 003 Jun 19, 2012
AB AUROBINDO PHARMA EQ 25MG BASE A078327 001 Aug 10, 2009
AB EQ 50MG BASE A078327 002 Aug 10, 2009
AB EQ 100MG BASE A078327 003 Aug 10, 2009
AB DR REDDYS LABS INC EQ 25MG BASE A076847 001 Aug 10, 2009
AB EQ 50MG BASE A076847 002 Aug 10, 2009
AB EQ 100MG BASE A076847 003 Aug 10, 2009
AB HIKMA PHARMS EQ 25MG BASE A078298 001 May 21, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
SUMATRIPTAN SUCCINATE
TABLET;ORAL
SUMATRIPTAN SUCCINATE
AB EQ 50MG BASE
AB EQ 100MG BASE
AB MYLAN EQ 25MG BASE
AB EQ 50MG BASE
AB EQ 100MG BASE
AB ORCHID HLTHCARE EQ 25MG BASE
AB EQ 50MG BASE
AB EQ 100MG BASE
AB RANBAXY EQ 25MG BASE
AB EQ 50MG BASE
AB EQ 100MG BASE
AB SANDOZ EQ 25MG BASE
AB EQ 50MG BASE
AB EQ 100MG BASE
AB SUN PHARM INDS EQ 25MG BASE
AB EQ 50MG BASE
AB EQ 100MG BASE
AB WATSON LABS EQ 25MG BASE
AB EQ 50MG BASE
AB EQ 100MG BASE
SUNITINIB MALATE
CAPSULE;ORAL
SUTENT
CPPI CV EQ 12.5MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
+ EQ 50MG BASE
TACROLIMUS
CAPSULE;ORAL
PROGRAF
AB ASTELLAS EQ 0.5MG BASE
AB EQ 1MG BASE
AB + EQ 5MG BASE
TACROLIMUS
AB ACCORD HLTHCARE EQ 0.5MG BASE
AB EQ 1MG BASE
AB EQ 5MG BASE
AB DR REDDYS LABS LTD EQ 0.5MG BASE
AB EQ 1MG BASE
AB EQ 5MG BASE
AB MYLAN EQ 0.5MG BASE
AB EQ 1MG BASE
AB EQ 5MG BASE
AB PANACEA BIOTEC LTD EQ 0.5MG BASE
AB EQ 1MG BASE
AB EQ 5MG BASE
AB SANDOZ EQ 0.5MG BASE
AB EQ 1MG BASE
AB EQ 5MG BASE
AB WATSON LABS EQ 5MG BASE
CAPSULE, EXTENDED RELEASE;ORAL
ASTAGRAF XL
ASTELLAS EQ 0.5MG BASE
EQ 1MG BASE
+ EQ 5MG BASE
INJECTABLE;INJECTION
PROGRAF
+ ASTELLAS EQ 5MG BASE/ML
OINTMENT;TOPICAL
PROTOPIC
+ ASTELLAS 0.03%
+ 0.1%
3-328( of 362)
A078298 002 May 21, 2013
A078298 003 May 21, 2013
A077744 001 Aug 10, 2009
A077744 002 Aug 10, 2009
A077744 003 Aug 10, 2009
A078284 001 Aug 10, 2009
A078284 002 Aug 10, 2009
A078284 003 Aug 10, 2009
A076554 001 Aug 10, 2009
A076554 002 Aug 10, 2009
A076572 001 Feb 09, 2009
A076976 001 Aug 10, 2009
A076976 002 Aug 10, 2009
A076976 003 Aug 10, 2009
A078295 001 Aug 10, 2009
A078295 002 Aug 10, 2009
A078295 003 Aug 10, 2009
A076933 001 Aug 10, 2009
A076933 002 Aug 10, 2009
A076933 003 Aug 10, 2009
N021938 001 Jan 26, 2006
N021938 002 Jan 26, 2006
N021938 004 Mar 31, 2009
N021938 003 Jan 26, 2006
N050708 003 Aug 24, 1998
N050708 001 Apr 08, 1994
N050708 002 Apr 08, 1994
A091195 001 Aug 31, 2011
A091195 002 Aug 31, 2011
A091195 003 Aug 31, 2011
A090509 001 May 12, 2010
A090509 002 May 12, 2010
A090509 003 May 12, 2010
A090596 001 Sep 17, 2010
A090596 002 Sep 17, 2010
A090596 003 Sep 17, 2010
A090802 001 Sep 28, 2012
A090802 002 Sep 28, 2012
A090802 003 Sep 28, 2012
A065461 001 Aug 10, 2009
A065461 002 Aug 10, 2009
A065461 003 Aug 10, 2009
A090402 001 Jul 01, 2010
N204096 001 Jul 19, 2013
N204096 002 Jul 19, 2013
N204096 003 Jul 19, 2013
N050709 001 Apr 08, 1994
N050777 001 Dec 08, 2000
N050777 002 Dec 08, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-329( of 362)
TADALAFIL
TABLET;ORAL
ADCIRCA
+ ELI LILLY CO 20MG N022332 001 May 22, 2009
CIALIS
LILLY 2.5MG N021368 004 Jan 07, 2008
5MG N021368 001 Nov 21, 2003
10MG N021368 002 Nov 21, 2003
+ 20MG N021368 003 Nov 21, 2003
TAFLUPROST
SOLUTION/DROPS;OPHTHALMIC
ZIOPTAN
+ MERCK SHARP DOHME 0.0015% N202514 001 Feb 10, 2012
TALC
AEROSOL, METERED;INTRAPLEURAL
SCLEROSOL
+ BRYAN 400MG/SPRAY N020587 001 Dec 24, 1997
POWDER;INTRAPLEURAL
TALC
+ BRYAN 5GM/BOT N021388 001 Dec 15, 2003
TALIGLUCERASE ALFA
POWDER;IV (INFUSION)
ELELYSO
+ PFIZER 200 UNITS/VIAL N022458 001 May 01, 2012
TAMOXIFEN CITRATE
SOLUTION;ORAL
SOLTAMOX
DARA BIOSCIENCES EQ 10MG BASE/5ML N021807 001 Oct 29, 2005
TABLET;ORAL
TAMOXIFEN CITRATE
AB APOTEX EQ 10MG BASE A090878 001 Sep 23, 2011
AB EQ 20MG BASE A090878 002 Sep 23, 2011
AB MYLAN EQ 10MG BASE A074732 002 Feb 20, 2003
AB EQ 20MG BASE A074732 001 Feb 20, 2003
AB TEVA EQ 10MG BASE A075797 001 Feb 20, 2003
AB + TEVA PHARMS EQ 20MG BASE A074858 001 Feb 20, 2003
AB WATSON LABS EQ 10MG BASE A070929 001 Feb 20, 2003
AB EQ 20MG BASE A070929 002 Feb 20, 2003
AB WATSON LABS FLORIDA EQ 10MG BASE A076179 001 Feb 20, 2003
AB EQ 20MG BASE A076179 002 Feb 20, 2003
TAMSULOSIN HYDROCHLORIDE
CAPSULE;ORAL
FLOMAX
AB + BOEHRINGER INGELHEIM 0.4MG N020579 001 Apr 15, 1997
TAMSULOSIN HYDROCHLORIDE
AB ANCHEN PHARMS 0.4MG A202010 001 Jan 04, 2013
AB AUROBINDO PHARMA LTD 0.4MG A202433 001 Apr 30, 2013
AB IMPAX LABS 0.4MG A090377 001 Mar 02, 2010
AB MYLAN 0.4MG A090408 001 Apr 27, 2010
AB SANDOZ 0.4MG A078015 001 Apr 27, 2010
AB SUN PHARM INDS LTD 0.4MG A090931 001 Jul 15, 2010
AB SYNTHON PHARMS 0.4MG A078801 001 Apr 27, 2010
AB TEVA PHARMS 0.4MG A077630 001 Apr 27, 2010
AB WOCKHARDT 0.4MG A078938 001 Apr 27, 2010
AB ZYDUS PHARMS USA INC 0.4MG A078225 001 Apr 27, 2010
TAPENTADOL HYDROCHLORIDE
SOLUTION;ORAL
NUCYNTA
+ JANSSEN PHARMS EQ 20MG BASE/ML N203794 001 Oct 15, 2012
TABLET;ORAL
NUCYNTA
JANSSEN PHARMS EQ 50MG BASE N022304 001 Nov 20, 2008
EQ 75MG BASE N022304 002 Nov 20, 2008
+ EQ 100MG BASE N022304 003 Nov 20, 2008
TABLET, EXTENDED RELEASE;ORAL
NUCYNTA ER
JANSSEN PHARMS EQ 50MG BASE N200533 001 Aug 25, 2011
EQ 100MG BASE N200533 002 Aug 25, 2011
EQ 150MG BASE N200533 003 Aug 25, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-330( of 362)
TAPENTADOL HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
NUCYNTA ER
EQ 200MG BASE N200533 004 Aug 25, 2011
+ EQ 250MG BASE N200533 005 Aug 25, 2011
TAZAROTENE
AEROSOL, FOAM;TOPICAL
FABIOR
+ STIEFEL LABS INC 0.1% N202428 001 May 11, 2012
CREAM;TOPICAL
AVAGE
+ ALLERGAN 0.1% N021184 003 Sep 30, 2002
TAZORAC
+ ALLERGAN 0.05% N021184 001 Sep 29, 2000
+ 0.1% N021184 002 Sep 29, 2000
GEL;TOPICAL
TAZORAC
+ ALLERGAN 0.05% N020600 001 Jun 13, 1997
+ 0.1% N020600 002 Jun 13, 1997
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
INJECTABLE;INJECTION
PULMOLITE
BS JUBILANT DRAXIMAGE N/A N017776 001
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT
BS DRAXIMAGE N/A N017881 001 Dec 30, 1987
TECHNETIUM TC-99M BICISATE KIT
INJECTABLE;INJECTION
NEUROLITE
LANTHEUS MEDCL N/A N020256 001 Nov 23, 1994
TECHNETIUM TC-99M DISOFENIN KIT
INJECTABLE;INJECTION
HEPATOLITE
PHARMALUCENCE N/A N018467 001 Mar 16, 1982
TECHNETIUM TC-99M EXAMETAZIME KIT
INJECTABLE;INJECTION
CERETEC
+ GE HEALTHCARE N/A N019829 001 Dec 30, 1988
TECHNETIUM TC-99M MEBROFENIN KIT
INJECTABLE;INJECTION
CHOLETEC
AP + BRACCO N/A N018963 001 Jan 21, 1987
TECHNETIUM TC-99M MEBROFENIN
AP PHARMALUCENCE N/A A078242 001 Jan 29, 2008
TECHNETIUM TC-99M MEDRONATE
INJECTABLE;INJECTION
DRAXIMAGE MDP-25
+ JUBILANT DRAXIMAGE N/A N018035 002 Feb 27, 2004
TECHNETIUM TC-99M MEDRONATE KIT
INJECTABLE;INJECTION
CIS-MDP
AP PHARMALUCENCE N/A N018124 001
MDP-BRACCO
AP BRACCO N/A N018107 001
TECHNETIUM TC-99M MERTIATIDE KIT
INJECTABLE;INJECTION
TECHNESCAN MAG3
+ MALLINCKRODT N/A N019882 001 Jun 15, 1990
TECHNETIUM TC-99M OXIDRONATE KIT
INJECTABLE;INJECTION
TECHNESCAN
+ MALLINCKRODT N/A N018321 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-331( of 362)
TECHNETIUM TC-99M PENTETATE KIT
INJECTABLE;INJECTION
AN-DTPA
AP
DTPA
JUBILANT DRAXIMAGE N/A N017714 001
AP DRAXIMAGE N/A N018511 001 Dec 29, 1989
TECHNETIUM TC-99M PYROPHOSPHATE KIT
INJECTABLE;INJECTION
CIS-PYRO
AP PHARMALUCENCE N/A N019039 001 Jun 30, 1987
TECHNESCAN PYP KIT
AP MALLINCKRODT N/A N017538 001
TECHNETIUM TC-99M RED BLOOD CELL KIT
INJECTABLE;INJECTION
ULTRATAG
MALLINCKRODT N/A N019981 001 Jun 10, 1991
TECHNETIUM TC-99M SESTAMIBI KIT
INJECTABLE;INJECTION
CARDIOLITE
AP + LANTHEUS MEDCL N/A N019785 001 Dec 21, 1990
TECHNETIUM TC 99M SESTAMIBI
AP CARDINAL HEALTH 414 N/A A078809 001 Apr 28, 2009
AP DRAXIMAGE N/A A078806 001 Apr 29, 2009
AP PHARMALUCENCE 10-30mCi A079157 001 Jul 10, 2009
TECHNETIUM TC-99 SESTAMIBI
AP MALLINCKRODT N/A A078098 001 Sep 22, 2008
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
SOLUTION;INJECTION, ORAL
TECHNELITE
+ LANTHEUS MEDCL 0.0083-2.7 CI/GENERATOR N017771 001
ULTRA-TECHNEKOW FM
+ MALLINCKRODT 0.25-3 CI/GENERATOR N017243 002
TECHNETIUM TC-99M SUCCIMER KIT
INJECTABLE;INJECTION
MPI DMSA KIDNEY REAGENT
GE HEALTHCARE N/A N017944 001 May 18, 1982
TECHNETIUM TC-99M SULFUR COLLOID KIT
SOLUTION;INJECTION, ORAL
AN-SULFUR COLLOID
+ PHARMALUCENCE N/A N017858 001
TECHNETIUM TC-99M TETROFOSMIN KIT
INJECTABLE;INJECTION
MYOVIEW
+ GE HEALTHCARE N/A N020372 001 Feb 09, 1996
MYOVIEW 30ML
+ GE HEALTHCARE N/A N020372 002 Jul 07, 2005
TECHNETIUM TC-99M TILMANOCEPT
INJECTABLE;INJECTION
LYMPHOSEEK KIT
+ NAVIDEA BIOPHARMS N/A N202207 001 Mar 13, 2013
TEDUGLUTIDE RECOMBINANT
POWDER;SUBCUTANEOUS
GATTEX KIT
+ NPS PHARMS INC 5MG/VIAL N203441 001 Dec 21, 2012
TELAPREVIR
TABLET;ORAL
INCIVEK
+ VERTEX PHARMS 375MG N201917 001 May 23, 2011
TELAVANCIN HYDROCHLORIDE
POWDER;IV (INFUSION)
VIBATIV
THERAVANCE INC EQ 250MG BASE/VIAL N022110 001 Sep 11, 2009
+ EQ 750MG BASE/VIAL N022110 002 Sep 11, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
TELBIVUDINE
TABLET;ORAL
TYZEKA
+ NOVARTIS 600MG
TELITHROMYCIN
TABLET;ORAL
KETEK
SANOFI AVENTIS US 300MG
+ 400MG
TELMISARTAN
TABLET;ORAL
MICARDIS
AB BOEHRINGER INGELHEIM 20MG
AB 40MG
AB + 80MG
TELMISARTAN
AB WATSON LABS 20MG
AB 40MG
AB 80MG
TEMAZEPAM
CAPSULE;ORAL
RESTORIL
AB MALLINCKRODT INC 7.5MG
AB 15MG
AB 22.5MG
AB + 30MG
TEMAZEPAM
AB ACTAVIS ELIZABETH 15MG
AB 30MG
AB MUTUAL PHARM 7.5MG
AB 22.5MG
AB MYLAN 7.5MG
AB 15MG
AB 22.5MG
AB 30MG
AB NOVEL LABS INC 7.5MG
AB 15MG
AB 22.5MG
AB 30MG
AB SANDOZ 15MG
AB 30MG
AB WATSON LABS 15MG
AB 30MG
TEMOZOLOMIDE
CAPSULE;ORAL
TEMODAR
AB MERCK SHARP DOHME 5MG
AB 20MG
AB 100MG
AB 140MG
AB 180MG
AB + 250MG
TEMOZOLOMIDE
AB BARR 5MG
AB 20MG
AB 100MG
AB 140MG
AB 180MG
AB 250MG
POWDER;INTRAVENOUS
TEMODAR
+ MERCK SHARP DOHME 100MG/VIAL
TEMSIROLIMUS
SOLUTION;INTRAVENOUS
TORISEL
+ PF PRISM CV 25MG/ML (25MG/ML)
3-332( of 362)
N022011 001 Oct 25, 2006
N021144 002 Feb 09, 2005
N021144 001 Apr 01, 2004
N020850 003 Apr 04, 2000
N020850 001 Nov 10, 1998
N020850 002 Nov 10, 1998
A078710 001 Jan 08, 2014
A078710 002 Jan 08, 2014
A078710 003 Jan 08, 2014
N018163 003 Oct 25, 1991
N018163 001
N018163 004 Nov 02, 2004
N018163 002
A071638 001 Aug 07, 1987
A071620 001 Aug 07, 1987
A078581 001 Sep 08, 2009
A071175 002 Sep 14, 2009
A070920 002 May 21, 2010
A070920 004 Jul 07, 1986
A070920 003 Jun 12, 2009
A070920 001 Jul 10, 1986
A071457 002 Jun 22, 2012
A071456 001 Apr 21, 1987
A071457 003 Jun 22, 2012
A071457 001 Apr 21, 1987
A071427 001 Jan 12, 1988
A071428 001 Jan 12, 1988
A071446 001 May 21, 1993
A071447 001 May 21, 1993
N021029 001 Aug 11, 1999
N021029 002 Aug 11, 1999
N021029 003 Aug 11, 1999
N021029 005 Oct 19, 2006
N021029 006 Oct 19, 2006
N021029 004 Aug 11, 1999
A078879 001 Mar 01, 2010
A078879 002 Mar 01, 2010
A078879 003 Mar 01, 2010
A078879 005 Mar 01, 2010
A078879 006 Mar 01, 2010
A078879 004 Mar 01, 2010
N022277 001 Feb 27, 2009
N022088 001 May 30, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-333( of 362)
TENIPOSIDE
INJECTABLE;INJECTION
VUMON
+ HQ SPECLT PHARMA 10MG/ML N020119 001 Jul 14, 1992
TENOFOVIR DISOPROXIL FUMARATE
POWDER;ORAL
VIREAD
+ GILEAD SCIENCES INC 40MG/SCOOPFUL N022577 001 Jan 18, 2012
TABLET;ORAL
VIREAD
GILEAD SCIENCES INC 150MG N021356 002 Jan 18, 2012
200MG N021356 003 Jan 18, 2012
250MG N021356 004 Jan 18, 2012
+ 300MG N021356 001 Oct 26, 2001
TERAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
HYTRIN
AB ABBOTT EQ 1MG BASE N020347 001 Dec 14, 1994
AB + EQ 2MG BASE N020347 002 Dec 14, 1994
AB EQ 5MG BASE N020347 003 Dec 14, 1994
AB EQ 10MG BASE N020347 004 Dec 14, 1994
TERAZOSIN HYDROCHLORIDE
AB APOTEX EQ 1MG BASE A075498 001 Apr 12, 2001
AB EQ 2MG BASE A075498 002 Apr 12, 2001
AB EQ 5MG BASE A075498 003 Apr 12, 2001
AB EQ 10MG BASE A075498 004 Apr 12, 2001
AB IVAX SUB TEVA PHARMS EQ 1MG BASE A075614 002 Jan 30, 2001
AB EQ 2MG BASE A075614 001 Jan 30, 2001
AB EQ 5MG BASE A075614 003 Jan 30, 2001
AB EQ 10MG BASE A075614 004 Jan 30, 2001
AB JUBILANT CADISTA EQ 1MG BASE A075317 001 Dec 20, 2004
AB EQ 2MG BASE A075317 002 Dec 20, 2004
AB EQ 5MG BASE A075317 003 Dec 20, 2004
AB EQ 10MG BASE A075317 004 Dec 20, 2004
AB MYLAN EQ 1MG BASE A075140 002 Feb 11, 2000
AB EQ 2MG BASE A075140 003 Feb 11, 2000
AB EQ 5MG BASE A075140 001 Feb 11, 2000
AB EQ 10MG BASE A075140 004 Feb 11, 2000
AB SANDOZ EQ 1MG BASE A074823 001 Mar 30, 1998
AB EQ 2MG BASE A074823 002 Mar 30, 1998
AB EQ 5MG BASE A074823 003 Mar 30, 1998
AB EQ 10MG BASE A074823 004 Mar 30, 1998
TABLET;ORAL
HYTRIN
ABBOTT EQ 1MG BASE N019057 001 Aug 07, 1987
+ EQ 2MG BASE N019057 002 Aug 07, 1987
EQ 5MG BASE N019057 003 Aug 07, 1987
EQ 10MG BASE N019057 004 Aug 07, 1987
TERBINAFINE HYDROCHLORIDE
GRANULE;ORAL
LAMISIL
NOVARTIS EQ 125MG BASE/PACKET N022071 001 Sep 28, 2007
+ EQ 187.5MG BASE/PACKET N022071 002 Sep 28, 2007
TABLET;ORAL
LAMISIL
AB + NOVARTIS EQ 250MG BASE N020539 001 May 10, 1996
TERBINAFINE HYDROCHLORIDE
AB APOTEX EQ 250MG BASE A078199 001 Jul 02, 2007
AB AUROBINDO PHARMA EQ 250MG BASE A078297 001 Jul 02, 2007
AB BRECKENRIDGE PHARM EQ 250MG BASE A077714 001 Jun 04, 2010
AB CIPLA LTD EQ 250MG BASE A077137 001 Jul 02, 2007
AB DR REDDYS LABS INC EQ 250MG BASE A076390 001 Jul 02, 2007
AB GLENMARK GENERICS EQ 250MG BASE A078157 001 Jul 02, 2007
AB HARRIS PHARM EQ 250MG BASE A077919 001 Jul 02, 2007
AB INVAGEN PHARMS EQ 250MG BASE A077533 001 Jul 02, 2007
AB MYLAN EQ 250MG BASE A077195 001 Jul 02, 2007
AB ORCHID HLTHCARE EQ 250MG BASE A078163 001 Jul 02, 2007
AB TEVA EQ 250MG BASE A076377 001 Jul 02, 2007
AB WOCKHARDT EQ 250MG BASE A078229 001 Jul 02, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-334( of 362)
TERBUTALINE SULFATE
INJECTABLE;INJECTION
TERBUTALINE SULFATE
AP AKORN 1MG/ML A078151 001 Jan 07, 2008
AP + BEDFORD 1MG/ML A076770 001 Apr 23, 2004
AP FRESENIUS KABI USA 1MG/ML A076887 001 May 26, 2004
AP HIKMA FARMACEUTICA 1MG/ML A078630 001 May 20, 2009
AP UNITED BIOMEDCL 1MG/ML A200122 001 Nov 08, 2013
TABLET;ORAL
TERBUTALINE SULFATE
AB IMPAX LABS 2.5MG A075877 001 Jun 26, 2001
AB + 5MG A075877 002 Jun 26, 2001
AB LANNETT 2.5MG A077152 001 Mar 25, 2005
AB 5MG A077152 002 Mar 25, 2005
TERCONAZOLE
CREAM;VAGINAL
TERAZOL 3
AB + JANSSEN PHARMS 0.8% N019964 001 Feb 21, 1991
TERAZOL 7
AB + JANSSEN PHARMS 0.4% N019579 001 Dec 31, 1987
TERCONAZOLE
AB FOUGERA PHARMS 0.4% A076712 001 Feb 18, 2005
AB TARO 0.4% A076043 001 Jan 19, 2005
AB 0.8% A075953 001 Apr 06, 2004
BX + NYCOMED US 0.8% N021735 001 Oct 01, 2004
SUPPOSITORY;VAGINAL
TERAZOL 3
AB + JANSSEN PHARMS 80MG N019641 001 May 24, 1988
TERCONAZOLE
AB PERRIGO NEW YORK 80MG A077149 001 Mar 17, 2006
TERIFLUNOMIDE
TABLET;ORAL
AUBAGIO
SANOFI AVENTIS US 7MG N202992 001 Sep 12, 2012
+ 14MG N202992 002 Sep 12, 2012
TERIPARATIDE RECOMBINANT HUMAN
INJECTABLE;SUBCUTANEOUS
FORTEO
+ LILLY 0.6MG/2.4ML (0.25MG/ML) N021318 002 Jun 25, 2008
TESAMORELIN ACETATE
POWDER;SUBCUTANEOUS
EGRIFTA
+ EMD SERONO EQ 2MG BASE/VIAL N022505 002 Nov 29, 2011
TESTOSTERONE
FILM, EXTENDED RELEASE;TRANSDERMAL
ANDRODERM
+ WATSON LABS 2MG/24HR N020489 003 Oct 20, 2011
+ 4MG/24HR N020489 004 Oct 20, 2011
GEL;TRANSDERMAL
ANDROGEL
BX + ABBVIE 1% (50MG/5GM PACKET) N021015 002 Feb 28, 2000
TESTIM
BX + AUXILIUM PHARMS 1% (50MG/5GM PACKET) N021454 001 Oct 31, 2002
ANDROGEL
ABBVIE 1% (25MG/2.5GM PACKET) N021015 001 Feb 28, 2000
1.62% (20.25MG/1.25GM PACKET) N022309 002 Sep 07, 2012
+ 1.62% (40.5MG/2.5GM PACKET) N022309 003 Sep 07, 2012
TESTOSTERONE
PERRIGO ISRAEL 25MG/2.5GM PACKET N203098 002 Jan 31, 2013
50MG/5GM PACKET N203098 003 Jan 31, 2013
TEVA PHARMS 25MG/2.5GM PACKET N202763 001 Feb 14, 2012
50MG/5GM PACKET N202763 002 Feb 14, 2012
GEL, METERED;TRANSDERMAL
ANDROGEL
+ ABBVIE 1% (12.5MG/1.25GM ACTUATION) N021015 003 Sep 26, 2003
+ 1.62% (20.25MG/1.25GM ACTUATION) N022309 001 Apr 29, 2011
FORTESTA
+ ENDO PHARMS 10MG/0.5GM ACTUATION N021463 001 Dec 29, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-335( of 362)
TESTOSTERONE
GEL, METERED;TRANSDERMAL
TESTOSTERONE
PERRIGO ISRAEL 12.5MG/1.25GM ACTUATION N203098 001 Jan 31, 2013
PELLET;IMPLANTATION
TESTOPEL
+ ACTIENT PHARMS 75MG A080911 001
SOLUTION, METERED;TRANSDERMAL
AXIRON
+ ELI LILLY AND CO 30MG/1.5ML ACTUATION N022504 001 Nov 23, 2010
TABLET, EXTENDED RELEASE;BUCCAL
STRIANT
+ ACTIENT PHARMS 30MG N021543 001 Jun 19, 2003
TESTOSTERONE CYPIONATE
INJECTABLE;INJECTION
DEPO-TESTOSTERONE
AO + PHARMACIA AND UPJOHN 100MG/ML A085635 002
AO + 200MG/ML A085635 003
TESTOSTERONE CYPIONATE
AO BEDFORD 100MG/ML A090387 001 Jul 15, 2010
AO 200MG/ML A090387 002 Jul 15, 2010
AO HIKMA FARMACEUTICA 200MG/ML A091244 001 May 01, 2012
AO MYLAN INSTITUTIONAL 200MG/ML A040652 001 Dec 11, 2006
AO PADDOCK LLC 200MG/ML A040530 001 Jan 31, 2005
AO SANDOZ 100MG/ML A040615 001 Aug 10, 2006
AO 200MG/ML A040615 002 Aug 10, 2006
AO SUN PHARM INDS LTD 100MG/ML A201720 001 Jun 03, 2013
AO 200MG/ML A201720 002 Jun 03, 2013
AO WATSON LABS 200MG/ML A086030 001
TESTOSTERONE ENANTHATE
INJECTABLE;INJECTION
DELATESTRYL
AO + ENDO PHARMS 200MG/ML N009165 003
TESTOSTERONE ENANTHATE
AO HIKMA FARMACEUTICA 200MG/ML A091120 001 Sep 18, 2012
AO MYLAN INSTITUTIONAL 200MG/ML A040647 001 Oct 05, 2009
AO PADDOCK LLC 200MG/ML A040575 001 Jun 14, 2006
AO WATSON LABS 200MG/ML A085598 001
TETRABENAZINE
TABLET;ORAL
XENAZINE
VALEANT BERMUDA 12.5MG N021894 001 Aug 15, 2008
+ 25MG N021894 002 Aug 15, 2008
TETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
ACHROMYCIN V
AB HERITAGE PHARMS INC 250MG N050278 003
AB 500MG N050278 001
TETRACYCLINE HYDROCHLORIDE
AB IMPAX LABS 250MG A060469 001
AB 500MG A060469 003
AB IVAX SUB TEVA PHARMS 250MG A060704 001
AB + 500MG A060704 002
AB WATSON LABS 250MG A061837 001
AB 500MG A061837 002
IMPAX LABS 100MG A060469 002
TETRAHYDROZOLINE HYDROCHLORIDE
SOLUTION;NASAL
TYZINE
+ FOUGERA PHARMS 0.05% A086576 002
0.1% A086576 001
SPRAY;NASAL
TYZINE
+ FOUGERA PHARMS 0.1% A086576 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-336( of 362)
THALIDOMIDE
CAPSULE;ORAL
THALOMID
CELGENE 50MG N020785 001 Jul 16, 1998
100MG N020785 002 Jan 17, 2003
150MG N020785 004 Jan 10, 2007
+ 200MG N020785 003 Jan 17, 2003
THALLOUS CHLORIDE TL-201
INJECTABLE;INJECTION
THALLOUS CHLORIDE TL 201
AP + GE HEALTHCARE 1mCi/ML N018110 002 Feb 27, 1996
AP + LANTHEUS MEDCL 1mCi/ML N017806 001
AP + MALLINCKRODT 1mCi/ML N018150 001
INJECTABLE;INTRAVENOUS
THALLOUS CHLORIDE TL 201
AP + LANTHEUS MEDCL 2mCi/ML N017806 002 Oct 09, 1998
THEOPHYLLINE
CAPSULE, EXTENDED RELEASE;ORAL
THEO-24
ACTIENT PHARMS 100MG A087942 001 Aug 22, 1983
200MG A087943 001 Aug 22, 1983
300MG A087944 001 Aug 22, 1983
+ 400MG A081034 001 Feb 28, 1992
ELIXIR;ORAL
ELIXOPHYLLIN
+ CARACO 80MG/15ML A085186 001
INJECTABLE;INJECTION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 40MG/100ML N019826 001 Aug 14, 1992
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 80MG/100ML N019826 002 Aug 14, 1992
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 160MG/100ML N019826 003 Aug 14, 1992
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 320MG/100ML N019826 006 Aug 14, 1992
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + HOSPIRA INC 4MG/ML N019211 007 Dec 14, 1984
AP + 40MG/100ML N019211 001 Dec 14, 1984
AP + 160MG/100ML N019211 003 Dec 14, 1984
AP + 320MG/100ML N019211 006 Jan 20, 1988
SOLUTION;ORAL
THEOPHYLLINE
AA + SILARX 80MG/15ML A091156 001 Apr 13, 2011
AA TRIS PHARMA INC 80MG/15ML A091586 001 Jun 15, 2012
TABLET;ORAL
THEOLAIR
+ MEDICIS 125MG A086399 001
+ 250MG A086399 002
TABLET, EXTENDED RELEASE;ORAL
THEOCHRON
AB CARACO 100MG A088320 001 Feb 21, 1985
AB 200MG A088321 001 Feb 21, 1985
AB 300MG A087400 002 Jan 11, 1983
THEOPHYLLINE
AB ALEMBIC LTD 300MG A090430 001 Oct 27, 2010
AB 450MG A090430 002 Oct 27, 2010
AB GLENMARK GENERICS 400MG A090355 001 Jul 13, 2010
AB 600MG A090355 002 Jul 13, 2010
AB NOSTRUM 400MG A040595 001 Apr 21, 2006
AB + 600MG A040560 002 Apr 21, 2006
AB + PLIVA 100MG A089807 001 Apr 30, 1990
AB + 200MG A089808 001 Apr 30, 1990
AB 300MG A089763 001 Apr 30, 1990
AB RHODES PHARMS 600MG A040086 001 Apr 15, 1996
AB + TEVA PHARMS 450MG A081236 001 Nov 09, 1992
UNIPHYL
AB RHODES PHARMS 400MG A087571 001 Sep 01, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
THIAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
THIAMINE HYDROCHLORIDE
AP + FRESENIUS KABI USA
AP MYLAN INSTITUTIONAL
AP WATSON LABS
+
THIOGUANINE
TABLET;ORAL
THIOGUANINE
+ ASPEN GLOBAL INC
THIORIDAZINE HYDROCHLORIDE
TABLET;ORAL
THIORIDAZINE HYDROCHLORIDE
AB MUTUAL PHARM
AB
AB
AB
AB MYLAN
AB
AB
AB +
THIOTEPA
INJECTABLE;INJECTION
THIOTEPA
BEDFORD
THIOTHIXENE
CAPSULE;ORAL
NAVANE
AB PFIZER
AB
AB +
AB
THIOTHIXENE
AB MYLAN
AB
AB
AB
AB SANDOZ
AB
AB
AB
AB WATSON LABS
AB
THYROTROPIN ALFA
INJECTABLE;INJECTION
THYROGEN
+ GENZYME
TIAGABINE HYDROCHLORIDE
TABLET;ORAL
GABITRIL
AB CEPHALON
AB +
TIAGABINE HYDROCHLORIDE
AB SUN PHARM INDS
AB
GABITRIL
CEPHALON
TICAGRELOR
TABLET;ORAL
BRILINTA
+ ASTRAZENECA LP
100MG/ML
100MG/ML
100MG/ML
200MG/ML
40MG
10MG
25MG
50MG
100MG
10MG
25MG
50MG
100MG
15MG/VIAL
1MG
2MG
5MG
10MG
1MG
2MG
5MG
10MG
1MG
2MG
5MG
10MG
2MG
5MG
1.1MG/VIAL
2MG
4MG
2MG
4MG
12MG
16MG
90MG
3-337( of 362)
A080556 001
A091623 001 Jun 25, 2012
A080571 001
A080571 002
N012429 001
A089953 004 Aug 01, 1986
A089953 003 Aug 01, 1986
A089953 002 Aug 01, 1986
A089953 001 Oct 07, 1988
A088004 002 Mar 15, 1983
A088004 003 Mar 15, 1983
A088004 004 Mar 15, 1983
A088004 001 Nov 18, 1983
A075547 001 Apr 02, 2001
N016584 001
N016584 002
N016584 003
N016584 004
A071093 002 Jun 23, 1987
A071093 003 Jun 23, 1987
A071093 004 Jun 23, 1987
A071093 001 Jun 23, 1987
A071610 001 Jun 24, 1987
A071570 001 Jun 24, 1987
A071529 001 Jun 24, 1987
A071530 001 Jun 24, 1987
A070601 001 Jun 05, 1987
A070602 001 Jun 05, 1987
N020898 001 Nov 30, 1998
N020646 005 Apr 16, 1999
N020646 001 Sep 30, 1997
A077555 001 Nov 04, 2011
A077555 002 Nov 04, 2011
N020646 002 Sep 30, 1997
N020646 003 Sep 30, 1997
N022433 001 Jul 20, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-338( of 362)
TICLOPIDINE HYDROCHLORIDE
TABLET;ORAL
TICLOPIDINE HYDROCHLORIDE
AB APOTEX 250MG A075089 001 Jul 01, 1999
AB CARACO 250MG A075526 001 Sep 26, 2002
AB + TEVA 250MG A075149 001 Aug 20, 1999
TIGECYCLINE
INJECTABLE;IV (INFUSION)
TYGACIL
+ PF PRISM CV 50MG/VIAL N021821 001 Jun 15, 2005
TIMOLOL
SOLUTION/DROPS;OPHTHALMIC
BETIMOL
+ SANTEN OY EQ 0.25% BASE N020439 001 Mar 31, 1995
+ EQ 0.5% BASE N020439 002 Mar 31, 1995
TIMOLOL MALEATE
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC
TIMOLOL MALEATE
AB FALCON PHARMS EQ 0.25% BASE N020963 001 Oct 21, 1998
AB EQ 0.5% BASE N020963 002 Oct 21, 1998
TIMOPTIC-XE
AB + VALEANT PHARMS LLC EQ 0.25% BASE N020330 001 Nov 04, 1993
AB + EQ 0.5% BASE N020330 002 Nov 04, 1993
SOLUTION/DROPS;OPHTHALMIC
TIMOLOL MALEATE
AT AKORN EQ 0.5% BASE A074466 001 Mar 25, 1997
AT EQ 0.5% BASE A074516 001 Mar 25, 1997
AT BAUSCH AND LOMB EQ 0.25% BASE A074778 001 Mar 25, 1997
AT EQ 0.5% BASE A074776 001 Mar 25, 1997
AT FALCON PHARMS EQ 0.25% BASE A074261 001 Apr 28, 1995
AT EQ 0.5% BASE A074262 001 Apr 28, 1995
AT FDC LTD EQ 0.25% BASE A077259 001 Apr 30, 2008
AT EQ 0.5% BASE A077259 002 Apr 30, 2008
AT HI TECH PHARMA EQ 0.5% BASE A075163 001 Sep 10, 2002
AT PACIFIC PHARMA EQ 0.25% BASE A074746 001 Mar 25, 1997
AT EQ 0.5% BASE A074747 001 Mar 25, 1997
AT WOCKHARDT EQ 0.25% BASE A078771 001 Sep 28, 2009
AT EQ 0.5% BASE A078771 002 Sep 28, 2009
TIMOPTIC
AT + ATON EQ 0.25% BASE N018086 001
AT + EQ 0.5% BASE N018086 002
ISTALOL
BT + BAUSCH AND LOMB EQ 0.5% BASE N021516 001 Jun 04, 2004
TIMOPTIC IN OCUDOSE
+ ATON EQ 0.25% BASE N019463 001 Nov 05, 1986
+ EQ 0.5% BASE N019463 002 Nov 05, 1986
TABLET;ORAL
TIMOLOL MALEATE
MYLAN 5MG A072668 002 Jun 08, 1990
10MG A072668 003 Jun 08, 1990
+ 20MG A072668 001 Jun 08, 1990
TINIDAZOLE
TABLET;ORAL
TINDAMAX
AB MISSION PHARMA 250MG N021618 001 May 17, 2004
AB + 500MG N021618 002 May 17, 2004
TINIDAZOLE
AB NOVEL LABS INC 250MG A202044 001 Apr 30, 2012
AB 500MG A202044 002 Apr 30, 2012
AB ROXANE 250MG A201172 001 Apr 30, 2012
AB 500MG A201172 002 Apr 30, 2012
AB UNIQUE PHARM LABS 250MG A202489 001 Oct 09, 2013
AB 500MG A202489 002 Oct 09, 2013
TIOPRONIN
TABLET;ORAL
THIOLA
+ MISSION PHARMA 100MG N019569 001 Aug 11, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-339( of 362)
TIOTROPIUM BROMIDE MONOHYDRATE
POWDER;INHALATION
SPIRIVA
+ BOEHRINGER INGELHEIM EQ 0.018MG BASE/INH N021395 001 Jan 30, 2004
TIPRANAVIR
CAPSULE;ORAL
APTIVUS
+ BOEHRINGER INGELHEIM 250MG N021814 001 Jun 22, 2005
SOLUTION;ORAL
APTIVUS
+ BOEHRINGER INGELHEIM 100MG/ML N022292 001 Jun 23, 2008
TIROFIBAN HYDROCHLORIDE
INJECTABLE;INJECTION
AGGRASTAT
MEDICURE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) N020913 002 May 17, 2002
+ EQ 12.5MG BASE/250ML (EQ 0.05MG N020913 003 Apr 20, 2000
BASE/ML)
TIZANIDINE HYDROCHLORIDE
CAPSULE;ORAL
TIZANIDINE HYDROCHLORIDE
AB APOTEX INC EQ 2MG BASE A078868 001 Feb 03, 2012
AB EQ 4MG BASE A078868 002 Feb 03, 2012
AB EQ 6MG BASE A078868 003 Feb 03, 2012
AB MYLAN PHARMS INC EQ 2MG BASE A091502 001 Nov 09, 2012
AB EQ 4MG BASE A091502 002 Nov 09, 2012
AB EQ 6MG BASE A091502 003 Nov 09, 2012
ZANAFLEX
AB ACORDA EQ 2MG BASE N021447 001 Aug 29, 2002
AB EQ 4MG BASE N021447 002 Aug 29, 2002
AB + EQ 6MG BASE N021447 003 Aug 29, 2002
TABLET;ORAL
TIZANIDINE HYDROCHLORIDE
AB APOTEX EQ 2MG BASE A076533 001 Jan 16, 2004
AB EQ 4MG BASE A076533 002 Jan 16, 2004
AB CARACO EQ 2MG BASE A076416 001 Sep 29, 2003
AB EQ 4MG BASE A076416 002 Sep 29, 2003
AB COREPHARMA EQ 2MG BASE A076347 001 Oct 11, 2002
AB EQ 4MG BASE A076347 002 Oct 11, 2002
AB DR REDDYS LABS INC EQ 2MG BASE A076286 001 Jul 03, 2002
AB EQ 4MG BASE A076286 002 Jul 03, 2002
AB MYLAN EQ 2MG BASE A076354 001 Mar 28, 2003
AB EQ 4MG BASE A076354 002 Mar 28, 2003
AB PROSAM LABS EQ 2MG BASE A076281 001 Oct 20, 2003
AB EQ 4MG BASE A076281 002 Oct 20, 2003
AB SANDOZ INC EQ 2MG BASE A076280 001 Nov 26, 2002
AB EQ 4MG BASE A076280 002 Jun 27, 2002
AB TEVA EQ 2MG BASE A076284 001 Jul 03, 2002
AB EQ 4MG BASE A076284 002 Jul 03, 2002
AB UNICHEM LABS LTD EQ 2MG BASE A091283 001 Nov 28, 2012
AB EQ 4MG BASE A091283 002 Nov 28, 2012
ZANAFLEX
AB + ACORDA EQ 4MG BASE N020397 001 Nov 27, 1996
TOBRAMYCIN
OINTMENT;OPHTHALMIC
TOBREX
+ ALCON 0.3% N050555 001
POWDER;INHALATION
TOBI PODHALER
+ NOVARTIS 28MG N201688 001 Mar 22, 2013
SOLUTION;INHALATION
TOBI
AN + NOVARTIS PHARMS 300MG/5ML N050753 001 Dec 22, 1997
TOBRAMYCIN
AN TEVA PHARMS USA 300MG/5ML A091589 001 Oct 10, 2013
BETHKIS
CORNERSTONE THERAP 300MG/4ML N201820 001 Oct 12, 2012
SOLUTION/DROPS;OPHTHALMIC
AKTOB
AT AKORN 0.3% A064096 001 Jan 31, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-340( of 362)
TOBRAMYCIN
SOLUTION/DROPS;OPHTHALMIC
TOBRAMYCIN
AT BAUSCH AND LOMB 0.3% A064052 001 Nov 29, 1993
AT FERA PHARMS 0.3% A065026 001 Sep 11, 2001
TOBREX
AT ALCON 0.3% A062535 001 Dec 13, 1984
AT + FALCON PHARMS 0.3% N050541 001
TOBRAMYCIN SULFATE
INJECTABLE;INJECTION
TOBRAMYCIN SULFATE
AP AGILA SPECLTS EQ 40MG BASE/ML A065407 001 Mar 11, 2008
AP FRESENIUS KABI USA EQ 1.2GM BASE/VIAL N050789 001 Jul 13, 2004
AP EQ 10MG BASE/ML A065122 001 Nov 29, 2002
AP + EQ 40MG BASE/ML A065122 002 Nov 29, 2002
AP HIKMA MAPLE EQ 40MG BASE/ML A063117 001 Apr 26, 1991
AP + HOSPIRA EQ 10MG BASE/ML A063112 001 Apr 30, 1991
AP EQ 40MG BASE/ML A063111 001 Apr 30, 1991
AP + EQ 40MG BASE/ML A063116 001 May 18, 1992
AP MARSAM PHARMS LLC EQ 10MG BASE/ML A062945 001 Aug 09, 1989
AP TEVA PHARMS USA EQ 40MG BASE/ML A063100 001 Jan 30, 1992
AP + X GEN PHARMS EQ 1.2GM BASE/VIAL A065013 001 Aug 17, 2001
TOBRAMYCIN SULFATE (PHARMACY BULK)
AP FRESENIUS KABI USA EQ 40MG BASE/ML A065120 001 Nov 29, 2002
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
+ HOSPIRA EQ 1.2MG BASE/ML A063081 003 Jul 31, 1990
+ EQ 1.6MG BASE/ML A063081 006 Jun 02, 1993
+ EQ 80MG BASE/100ML A063081 001 Jul 31, 1990
TOFACITINIB CITRATE
TABLET;ORAL
XELJANZ
+ PF PRISM CV EQ 5MG BASE N203214 001 Nov 06, 2012
TOLAZAMIDE
TABLET;ORAL
TOLAZAMIDE
MYLAN PHARMS INC 250MG A070259 001 Jan 02, 1986
+ 500MG A070259 003 Mar 17, 1986
TOLBUTAMIDE
TABLET;ORAL
TOLBUTAMIDE
+ MYLAN PHARMS INC 500MG A086445 001
TOLCAPONE
TABLET;ORAL
TASMAR
+ VALEANT PHARMS LLC 100MG N020697 001 Jan 29, 1998
TOLMETIN SODIUM
CAPSULE;ORAL
TOLMETIN SODIUM
AB MYLAN EQ 400MG BASE A073393 001 May 27, 1993
AB + TEVA EQ 400MG BASE A073290 001 Nov 27, 1991
TABLET;ORAL
TOLMETIN SODIUM
AB MUTUAL PHARM EQ 200MG BASE A073310 001 Nov 27, 1991
AB + MYLAN EQ 600MG BASE A074473 001 Aug 30, 1994
TOLTERODINE TARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
DETROL LA
AB PHARMACIA AND UPJOHN 2MG N021228 001 Dec 22, 2000
AB + 4MG N021228 002 Dec 22, 2000
TOLTERODINE TARTRATE
AB MYLAN PHARMS INC 2MG A201486 001 Oct 31, 2013
AB 4MG A201486 002 Oct 31, 2013
TABLET;ORAL
DETROL
AB PHARMACIA AND UPJOHN 1MG N020771 001 Mar 25, 1998
AB + 2MG N020771 002 Mar 25, 1998
TOLTERODINE TARTRATE
AB APOTEX CORP 1MG A200164 001 Sep 25, 2012
AB 2MG A200164 002 Sep 25, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-341( of 362)
TOLTERODINE TARTRATE
TABLET;ORAL
TOLTERODINE TARTRATE
AB MYLAN PHARMS INC 1MG A202641 001 Nov 27, 2012
AB 2MG A202641 002 Nov 27, 2012
TOLVAPTAN
TABLET;ORAL
SAMSCA
OTSUKA AMERICA PHARM 15MG N022275 001 May 19, 2009
+ 30MG N022275 002 May 19, 2009
TOPIRAMATE
CAPSULE;ORAL
TOPAMAX
AB JANSSEN PHARMS 15MG N020844 001 Oct 26, 1998
AB + 25MG N020844 002 Oct 26, 1998
TOPIRAMATE
AB MYLAN 15MG A078418 001 Oct 14, 2009
AB 25MG A078418 002 Oct 14, 2009
AB TEVA 15MG A076575 001 Apr 17, 2009
AB 25MG A076575 002 Apr 17, 2009
AB WATSON LABS 15MG A077868 001 Apr 15, 2009
AB 25MG A077868 002 Apr 15, 2009
AB ZYDUS PHARMS USA INC 15MG A078877 001 Oct 14, 2009
AB 25MG A078877 002 Oct 14, 2009
CAPSULE, EXTENDED RELEASE;ORAL
TROKENDI XR
SUPERNUS PHARMS 25MG N201635 001 Aug 16, 2013
50MG N201635 002 Aug 16, 2013
100MG N201635 003 Aug 16, 2013
+ 200MG N201635 004 Aug 16, 2013
TABLET;ORAL
TOPAMAX
AB JANSSEN PHARMS 25MG N020505 004 Dec 24, 1996
AB 50MG N020505 005 Dec 24, 1996
AB + 100MG N020505 001 Dec 24, 1996
AB 200MG N020505 002 Dec 24, 1996
TOPIRAMATE
AB ACCORD HLTHCARE 25MG A076311 001 Mar 27, 2009
AB 50MG A076311 002 Mar 27, 2009
AB 100MG A076311 003 Mar 27, 2009
AB 200MG A076311 004 Mar 27, 2009
AB ACTIVIS TOTOWA LLC 25MG A078637 001 Feb 27, 2013
AB 50MG A078637 002 Feb 27, 2013
AB 100MG A078637 003 Feb 27, 2013
AB 200MG A078637 004 Feb 27, 2013
AB APOTEX INC 25MG A077733 001 Mar 27, 2009
AB 50MG A077733 002 Mar 27, 2009
AB 100MG A077733 003 Mar 27, 2009
AB 200MG A077733 004 Mar 27, 2009
AB AUROBINDO PHARMA 25MG A078462 001 Mar 27, 2009
AB 50MG A078462 002 Mar 27, 2009
AB 100MG A078462 003 Mar 27, 2009
AB 200MG A078462 004 Mar 27, 2009
AB CIPLA LTD 25MG A076343 001 Mar 27, 2009
AB 50MG A076343 002 Mar 27, 2009
AB 100MG A076343 003 Mar 27, 2009
AB 200MG A076343 004 Mar 27, 2009
AB GLENMARK GENERICS 25MG A077627 001 Mar 27, 2009
AB 50MG A077627 002 Mar 27, 2009
AB 100MG A077627 003 Mar 27, 2009
AB 200MG A077627 004 Mar 27, 2009
AB INVAGEN PHARMS 25MG A079162 001 Mar 27, 2009
AB 50MG A079162 002 Mar 27, 2009
AB 100MG A079162 003 Mar 27, 2009
AB 200MG A079162 004 Mar 27, 2009
AB LUPIN 25MG A078410 001 Sep 11, 2013
AB 50MG A078410 002 Sep 11, 2013
AB 100MG A078410 003 Sep 11, 2013
AB 200MG A078410 004 Sep 11, 2013
AB MYLAN 25MG A076314 001 Mar 27, 2009
AB 50MG A076314 002 Mar 27, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
TOPIRAMATE
TABLET;ORAL
TOPIRAMATE
AB
AB
AB RANBAXY
AB
AB
AB SUN PHARM INDS LTD
AB
AB
AB
AB TEVA
AB
AB
AB
AB TORRENT PHARMS
AB
AB
AB
AB UNICHEM LABS LTD
AB
AB
AB
AB UPSHER SMITH
AB
AB
AB
AB WATSON LABS
AB
AB
AB
AB WOCKHARDT USA
AB
AB
AB
AB ZYDUS PHARMS USA INC
AB
AB
AB
TOPIRAMATE
AB HIKMA PHARMS
AB
AB
AB
TOPOTECAN HYDROCHLORIDE
CAPSULE;ORAL
HYCAMTIN
GLAXO WELLCOME
+
INJECTABLE;INJECTION
HYCAMTIN
AP + GLAXOSMITHKLINE
TOPOTECAN HYDROCHLORIDE
AP ACCORD HLTHCARE
AP ACTAVIS TOTOWA
AP DR REDDYS LABS LTD
AP FRESENIUS KABI ONCOL
AP FRESENIUS KABI USA
AP MYLAN INSTITUTIONAL
AP ONCO THERAPIES LTD
AP SAGENT PHARMS
AP SUN PHARM INDS LTD
AP THREE RIVERS PHARMS
SOLUTION;INTRAVENOUS
TOPOTECAN HYDROCHLORIDE
AP + HOSPIRA INC
AP TEVA PHARMS USA
100MG
200MG
25MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
EQ 0.25MG BASE
EQ 1MG BASE
EQ 4MG BASE/VIAL
EQ 4MG BASE/VIAL
EQ 4MG BASE/VIAL
EQ 4MG BASE/VIAL
EQ 4MG BASE/VIAL
EQ 4MG BASE/VIAL
EQ 4MG BASE/VIAL
EQ 4MG BASE/VIAL
EQ 4MG BASE/VIAL
EQ 4MG BASE/VIAL
EQ 4MG BASE/VIAL
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
3-342( of 362)
A076314 003 Mar 27, 2009
A076314 004 Mar 27, 2009
A076327 001 Mar 27, 2009
A076327 002 Mar 27, 2009
A076327 003 Mar 27, 2009
A090278 001 Mar 27, 2009
A090278 002 Mar 27, 2009
A090278 003 Mar 27, 2009
A090278 004 Mar 27, 2009
A076317 001 Mar 27, 2009
A076317 002 Mar 27, 2009
A076317 003 Mar 27, 2009
A076317 004 Mar 27, 2009
A079153 001 Mar 27, 2009
A079153 002 Mar 27, 2009
A079153 003 Mar 27, 2009
A079153 004 Mar 27, 2009
A090162 001 Mar 27, 2009
A090162 002 Mar 27, 2009
A090162 003 Mar 27, 2009
A090162 004 Feb 19, 2013
A078499 001 Jan 07, 2010
A078499 002 Jan 07, 2010
A078499 003 Jan 07, 2010
A078499 004 Jan 07, 2010
A077643 001 Mar 27, 2009
A077643 002 Mar 27, 2009
A077643 003 Mar 27, 2009
A077643 004 Mar 27, 2009
A090353 001 Sep 01, 2010
A090353 002 Sep 01, 2010
A090353 003 Sep 01, 2010
A090353 004 Sep 01, 2010
A078235 001 Mar 27, 2009
A078235 002 Mar 27, 2009
A078235 003 Mar 27, 2009
A078235 004 Mar 27, 2009
A091185 001 Nov 25, 2013
A091185 002 Nov 25, 2013
A091185 003 Nov 25, 2013
A091185 004 Nov 25, 2013
N020981 001 Oct 11, 2007
N020981 002 Oct 11, 2007
N020671 001 May 28, 1996
A202351 001 Jun 26, 2013
A090620 001 Dec 02, 2010
A201191 001 Mar 09, 2011
A091376 001 Nov 29, 2010
A091089 001 Nov 29, 2010
A201166 001 Aug 08, 2012
A091542 001 Aug 28, 2012
A091284 001 Jan 26, 2011
A202203 001 Aug 29, 2013
A091199 001 Dec 01, 2010
N200582 001 Feb 02, 2011
N022453 001 Dec 20, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-343( of 362)
TOREMIFENE CITRATE
TABLET;ORAL
FARESTON
+ PROSTRAKAN INC EQ 60MG BASE N020497 001 May 29, 1997
TORSEMIDE
INJECTABLE;INJECTION
TORSEMIDE
AP + BEDFORD LABS 20MG/2ML (10MG/ML) A078007 001 Jun 11, 2008
AP + 50MG/5ML (10MG/ML) A078007 002 Jun 11, 2008
AP LUITPOLD 20MG/2ML (10MG/ML) A090656 001 Apr 21, 2010
AP 50MG/5ML (10MG/ML) A090656 002 Apr 21, 2010
TABLET;ORAL
DEMADEX
AB MEDA PHARMS 5MG N020136 001 Aug 23, 1993
AB 10MG N020136 002 Aug 23, 1993
AB + 20MG N020136 003 Aug 23, 1993
AB 100MG N020136 004 Aug 23, 1993
TORSEMIDE
AB APOTEX INC 5MG A076894 001 May 31, 2005
AB 10MG A076894 002 May 31, 2005
AB 20MG A076894 003 May 31, 2005
AB 100MG A076894 004 May 31, 2005
AB AUROBINDO PHARMA 5MG A078249 001 Oct 17, 2007
AB 10MG A078249 002 Oct 17, 2007
AB 20MG A078249 003 Oct 17, 2007
AB 100MG A078249 004 Oct 17, 2007
AB HETERO LABS LTD III 5MG A079234 001 Jan 27, 2009
AB 10MG A079234 002 Jan 27, 2009
AB 20MG A079234 003 Jan 27, 2009
AB 100MG A079234 004 Jan 27, 2009
AB PAR PHARM 5MG A076226 001 May 27, 2003
AB 10MG A076226 002 May 27, 2003
AB 20MG A076226 003 May 27, 2003
AB 100MG A076226 004 May 27, 2003
AB PLIVA PHARM IND 5MG A076346 001 May 30, 2003
AB 10MG A076346 002 May 30, 2003
AB 20MG A076346 003 May 30, 2003
AB 100MG A076346 004 Oct 19, 2004
AB ROXANE 5MG A076943 001 Mar 01, 2005
AB 10MG A076943 002 Mar 01, 2005
AB 20MG A076943 003 Mar 01, 2005
AB SUN PHARM INDS 5MG A078478 001 Feb 26, 2008
AB 10MG A078478 002 Feb 26, 2008
AB 20MG A078478 003 Feb 26, 2008
AB 100MG A078478 004 Feb 26, 2008
AB TEVA 5MG A076110 001 May 14, 2002
AB 10MG A076110 002 May 14, 2002
AB 20MG A076110 003 May 14, 2002
AB 100MG A076110 004 May 14, 2002
AB VINTAGE PHARMS 5MG A090613 001 Mar 22, 2011
AB 10MG A090613 002 Mar 22, 2011
AB 20MG A090613 003 Mar 22, 2011
AB 100MG A090613 004 Mar 22, 2011
TRAMADOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
CONZIP
+ CIPHER PHARMS INC 100MG N022370 001 May 07, 2010
150MG N022370 004 Aug 01, 2011
200MG N022370 002 May 07, 2010
300MG N022370 003 May 07, 2010
TABLET;ORAL
TRAMADOL HYDROCHLORIDE
AB ACCORD HLTHCARE INC 50MG A202390 001 May 16, 2013
AB ALVOGEN 50MG A202075 001 Nov 28, 2011
AB AMNEAL PHARMS 50MG A076003 001 Jun 20, 2002
AB APOTEX 50MG A075981 001 Jul 10, 2002
AB CARACO 50MG A075964 001 Jun 19, 2002
AB CSPC OUYI PHARM CO 50MG A091498 001 Mar 29, 2013
AB IPCA LABS LTD 50MG A201973 001 Nov 16, 2012
AB MALLINCKRODT 50MG A075983 001 Jun 25, 2002
AB MUTUAL PHARM 50MG A076100 001 Jun 20, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-344( of 362)
TRAMADOL HYDROCHLORIDE
TABLET;ORAL
TRAMADOL HYDROCHLORIDE
AB MYLAN 50MG A075986 001 Jun 21, 2002
AB MYLAN PHARMS INC 50MG A075980 001 Nov 21, 2002
AB NORTHSTAR HLTHCARE 50MG A078935 001 May 26, 2010
AB PLIVA 50MG A075982 001 Jul 01, 2002
AB TEVA 50MG A075977 001 Jun 19, 2002
AB WATSON LABS 50MG A075962 001 Jun 24, 2002
AB ZYDUS PHARMS USA INC 50MG A090404 001 Jan 31, 2011
ULTRAM
AB + JANSSEN PHARMS 50MG N020281 002 Mar 03, 1995
TABLET, EXTENDED RELEASE;ORAL
TRAMADOL HYDROCHLORIDE
AB1 LUPIN LTD 100MG A200503 001 Aug 29, 2011
AB1 200MG A200503 002 Aug 29, 2011
AB1 300MG A200503 003 Aug 29, 2011
AB1 PAR PHARM INC 100MG A078783 001 Nov 13, 2009
AB1 200MG A078783 002 Nov 13, 2009
AB1 300MG A078783 003 Sep 20, 2011
AB1 SUN PHARMA GLOBAL 100MG A201384 001 Dec 07, 2011
AB1 200MG A201384 002 Dec 07, 2011
AB1 300MG A201384 003 Dec 07, 2011
ULTRAM ER
AB1 + VALEANT INTL 100MG N021692 001 Sep 08, 2005
AB1 200MG N021692 002 Sep 08, 2005
AB1 300MG N021692 003 Sep 08, 2005
TRAMADOL HYDROCHLORIDE
AB2 ACTAVIS ELIZABETH 100MG A091609 001 Jun 27, 2012
AB2 200MG A091609 002 Jun 27, 2012
AB2 300MG A091609 003 Jun 27, 2012
AB2 ANCHEN PHARMS 100MG A200491 001 Jun 27, 2012
AB2 200MG A200491 002 Jun 27, 2012
AB2 300MG A200491 003 Jun 27, 2012
AB2 + SUN PHARMA GLOBAL 100MG A091607 001 Dec 30, 2011
AB2 200MG A091607 002 Dec 30, 2011
AB2 300MG A091607 003 Dec 30, 2011
TRAMETINIB DIMETHYL SULFOXIDE
TABLET;ORAL
MEKINIST
GLAXOSMITHKLINE LLC EQ 0.5MG NON-SOLVATED PARENT N204114 001 May 29, 2013
EQ 1MG NON-SOLVATED PARENT N204114 002 May 29, 2013
+ EQ 2MG NON-SOLVATED PARENT N204114 003 May 29, 2013
TRANDOLAPRIL
TABLET;ORAL
MAVIK
AB ABBVIE 1MG N020528 001 Apr 26, 1996
AB 2MG N020528 002 Apr 26, 1996
AB + 4MG N020528 003 Apr 26, 1996
TRANDOLAPRIL
AB AUROBINDO PHARMA 1MG A078438 001 Jun 12, 2007
AB 2MG A078438 002 Jun 12, 2007
AB 4MG A078438 003 Jun 12, 2007
AB COREPHARMA 1MG A077256 001 Jun 12, 2007
AB 2MG A077256 002 Jun 12, 2007
AB 4MG A077256 003 Jun 12, 2007
AB EPIC PHARMA 1MG A078508 003 Jun 18, 2008
AB 2MG A078508 001 Jun 18, 2008
AB 4MG A078508 002 Jun 18, 2008
AB INVAGEN PHARMS 1MG A078320 001 Jun 12, 2007
AB 2MG A078320 002 Jun 12, 2007
AB 4MG A078320 003 Jun 12, 2007
AB LUPIN 1MG A077522 001 Jun 12, 2007
AB 2MG A077522 002 Jun 12, 2007
AB 4MG A077522 003 Jun 12, 2007
AB MYLAN 1MG A078346 001 Apr 28, 2008
AB 2MG A078346 002 Apr 28, 2008
AB 4MG A078346 003 Apr 28, 2008
AB TEVA PHARMS 1MG A077489 001 Dec 12, 2006
AB 2MG A077489 002 Dec 12, 2006
AB 4MG A077489 003 Dec 12, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
TRANDOLAPRIL
TABLET;ORAL
TRANDOLAPRIL
AB WATSON LABS 1MG
AB 2MG
AB 4MG
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
TARKA
AB ABBVIE 1MG;240MG
AB 2MG;180MG
AB 2MG;240MG
AB + 4MG;240MG
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
AB GLENMARK GENERICS
AB
AB
AB
TRANEXAMIC ACID
INJECTABLE;INJECTION
CYKLOKAPRON
AP + PHARMACIA AND UPJOHN
TRANEXAMIC ACID
AP FRESENIUS KABI USA
AP LUITPOLD
AP MYLAN INSTITUTIONAL
AP VERSAPHARM INC
AP X-GEN PHARMS INC
TABLET;ORAL
LYSTEDA
AB + FERRING PHARMS AS
TRANEXAMIC ACID
AB WATSON LABS INC FL
TRANYLCYPROMINE SULFATE
TABLET;ORAL
PARNATE
AB + COVIS PHARMA
TRANYLCYPROMINE SULFATE
AB PAR PHARM
TRAVOPROST
SOLUTION/DROPS;OPHTHALMIC
TRAVATAN Z
+ ALCON PHARMS LTD
TRAVOPROST
PAR PHARM
TRAZODONE HYDROCHLORIDE
TABLET;ORAL
TRAZODONE HYDROCHLORIDE
AB ALVOGEN
AB
AB APOTEX
AB + APOTEX INC
AB
AB
AB MUTUAL PHARM
AB
AB
AB MYLAN PHARMS INC
AB
AB
AB
AB PLIVA
AB TEVA PHARMS USA
AB
AB TORRENT PHARMS LTD
AB
AB
AB
AB VINTAGE
AB
1MG;240MG
2MG;180MG
2MG;240MG
4MG;240MG
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
650MG
650MG
EQ 10MG BASE
EQ 10MG BASE
0.004%
0.004%
50MG
100MG
50MG
100MG
150MG
300MG
50MG
100MG
150MG
50MG
100MG
150MG
300MG
150MG
50MG
100MG
50MG
100MG
150MG
300MG
50MG
100MG
3-345( of 362)
A077805 001 Jun 12, 2007
A077805 002 Jun 12, 2007
A077805 003 Jun 12, 2007
N020591 003 Oct 22, 1996
N020591 001 Oct 22, 1996
N020591 004 Oct 22, 1996
N020591 002 Oct 22, 1996
A079135 004 Aug 30, 2010
A079135 001 May 26, 2010
A079135 002 May 26, 2010
A079135 003 May 05, 2010
N019281 001 Dec 30, 1986
A091596 001 Mar 02, 2012
A201885 001 Aug 10, 2011
A091657 001 Nov 03, 2011
A202373 001 Nov 17, 2011
A201580 001 Jun 14, 2013
N022430 001 Nov 13, 2009
A202093 001 Dec 27, 2012
N012342 003 Aug 16, 1985
A040640 001 Jun 29, 2006
N021994 001 Sep 21, 2006
A091340 001 Mar 01, 2013
A071636 001 Apr 18, 1988
A071514 001 Apr 18, 1988
A071258 001 Mar 25, 1987
A071196 001 Mar 25, 1987
A071196 002 Apr 26, 1999
A071196 003 Apr 26, 1999
A073137 002 Mar 24, 1993
A073137 001 Mar 24, 1993
A073137 003 Dec 22, 1995
A090514 001 Jun 02, 2009
A090514 002 Jun 02, 2009
A090514 003 Jun 02, 2009
A090514 004 Jun 02, 2009
A071525 001 Mar 09, 1988
A071523 001 Dec 11, 1987
A071524 001 Dec 11, 1987
A202180 001 Nov 27, 2013
A202180 002 Nov 27, 2013
A202180 003 Nov 27, 2013
A202180 004 Nov 27, 2013
A072192 001 Feb 02, 1989
A072193 001 Feb 02, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-346( of 362)
TRAZODONE HYDROCHLORIDE
TABLET;ORAL
TRAZODONE HYDROCHLORIDE
AB WATSON LABS 50MG A070857 001 Oct 10, 1986
AB 100MG A070858 001 Oct 10, 1986
TABLET, EXTENDED RELEASE;ORAL
OLEPTRO
+ ANGELINI PHARMA 150MG N022411 001 Feb 02, 2010
300MG N022411 002 Feb 02, 2010
TREPROSTINIL
INJECTABLE;IV (INFUSION)-SC
REMODULIN
UNITED THERAP 1MG/ML N021272 001 May 21, 2002
2.5MG/ML N021272 002 May 21, 2002
5MG/ML N021272 003 May 21, 2002
+ 10MG/ML N021272 004 May 21, 2002
SOLUTION;INHALATION
TYVASO
+ UNITED THERAP EQ 0.6MG BASE/ML N022387 001 Jul 30, 2009
TABLET, EXTENDED RELEASE;ORAL
ORENITRAM
UNITED THERAP 0.125MG N203496 001 Dec 20, 2013
0.25MG N203496 002 Dec 20, 2013
1MG N203496 003 Dec 20, 2013
+ 2.5MG N203496 004 Dec 20, 2013
TRETINOIN
CAPSULE;ORAL
TRETINOIN
AB ANCHEN PHARMS 10MG A201687 001 Oct 24, 2012
AB + BARR LABS INC 10MG A077684 001 Jun 22, 2007
CREAM;TOPICAL
AVITA
AB MYLAN PHARMS INC 0.025% N020404 003 Jan 14, 1997
RETIN-A
AB + VALEANT BERMUDA 0.025% N019049 001 Sep 16, 1988
AB + 0.1% N017340 001
TRETINOIN
AB PRECISION DERMAT 0.025% A075264 001 Dec 24, 1998
AB 0.1% A075213 001 Dec 24, 1998
RETIN-A
AB1 + VALEANT BERMUDA 0.05% N017522 001
TRETINOIN
AB1 PRECISION DERMAT 0.05% A075265 001 Dec 24, 1998
RENOVA
AB2 + VALEANT INTL 0.05% N019963 001 Dec 29, 1995
TRETINOIN
AB2 SUNEVA MEDCL 0.05% A076498 001 Sep 15, 2005
RENOVA
+ VALEANT INTL 0.02% N021108 001 Aug 31, 2000
TRETINOIN
+ PRECISION DERMAT 0.0375% A090098 001 Mar 22, 2010
0.075% A202209 001 Oct 11, 2012
GEL;TOPICAL
RETIN-A
AB + VALEANT INTL 0.01% N017955 001
AB + 0.025% N017579 002
RETIN-A MICRO
AB + VALEANT INTL 0.04% N020475 002 May 10, 2002
AB + 0.1% N020475 001 Feb 07, 1997
TRETINOIN
AB PRECISION DERMAT 0.01% A075589 001 Jun 11, 2002
AB 0.025% A075529 001 Feb 22, 2000
AB SPEAR PHARMS INC 0.04% A202567 001 Jul 17, 2013
AB 0.1% A202026 001 Jul 17, 2013
AVITA
BT MYLAN 0.025% N020400 001 Jan 29, 1998
ATRALIN
+ DOW PHARM 0.05% N022070 001 Jul 26, 2007
SOLUTION;TOPICAL
RETIN-A
AT + VALEANT INTL 0.05% N016921 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-347( of 362)
TRETINOIN
SOLUTION;TOPICAL
TRETINOIN
AT WOCKHARDT 0.05% A075260 001 Jan 25, 1999
TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
TRIAMCINOLONE ACETONIDE
AT + FOUGERA PHARMS 0.025% A085692 001
AT + 0.1% A085692 003
AT + 0.5% A085692 002
AT PERRIGO NEW YORK 0.025% A086415 001
AT 0.1% A086414 001
AT 0.5% A086413 001
AT TARO 0.1% A040039 001 Nov 26, 1997
AT VINTAGE 0.025% A040671 001 Jun 09, 2006
AT 0.1% A040671 002 Jun 09, 2006
TRIDERM
AT CROWN LABS 0.1% A088042 001 Mar 19, 1984
INJECTABLE;INJECTION
KENALOG-10
AB APOTHECON 10MG/ML N012041 001
KENALOG-40
AB + APOTHECON 40MG/ML N014901 001
TRIAMCINOLONE ACETONIDE
AB SANDOZ 10MG/ML A090166 001 May 27, 2009
AB SANDOZ CANADA INC 40MG/ML A090164 001 Jun 01, 2009
INJECTABLE;INTRAVITREAL
TRIESENCE
+ ALCON 40MG/ML (40MG/ML) N022048 001 Nov 29, 2007
LOTION;TOPICAL
TRIAMCINOLONE ACETONIDE
AT FOUGERA PHARMS 0.025% A040467 001 Apr 21, 2003
AT 0.1% A040467 002 Apr 21, 2003
AT TARO 0.1% A089129 001 Aug 14, 1986
AT VERSAPHARM INC 0.025% A202374 001 May 08, 2013
AT 0.1% A202374 002 May 08, 2013
AT VINTAGE 0.1% A040672 002 Dec 13, 2006
AT + WOCKHARDT 0.1% A088451 001 Apr 03, 1985
AT + WOCKHARDT EU OPERATN 0.025% A088450 001 Apr 01, 1985
OINTMENT;TOPICAL
TRIAMCINOLONE ACETONIDE
AT FOUGERA PHARMS 0.025% A085691 001
AT 0.1% A085691 003
AT 0.5% A085691 002
AT + PERRIGO NEW YORK 0.025% A087356 001
AT + 0.1% A087357 001
AT + 0.5% A087385 001
AT TARO 0.1% A040037 001 Sep 30, 1994
TRIAMCINOLONE ACETONIDE IN ABSORBASE
+ CAROLINA MEDCL 0.05% A089595 001 Mar 23, 1995
PASTE;DENTAL
TRIAMCINOLONE ACETONIDE
AT LYNE 0.1% A040771 001 Jul 01, 2010
AT + TARO 0.1% A070730 001 Oct 01, 1986
SPRAY;TOPICAL
KENALOG
+ RANBAXY 0.147MG/GM N012104 001
SPRAY, METERED;NASAL
TRIAMCINOLONE ACETONIDE
TEVA PHARMS 0.055MG/SPRAY A078104 001 Jul 30, 2009
TRIAMCINOLONE HEXACETONIDE
INJECTABLE;INJECTION
ARISTOSPAN
+ SANDOZ 5MG/ML N016466 001
+ 20MG/ML N016466 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
TRIAMTERENE
CAPSULE;ORAL
DYRENIUM
WELLSPRING PHARM
+
TRIAZOLAM
TABLET;ORAL
HALCION
AB PHARMACIA AND UPJOHN
AB +
TRIAZOLAM
AB MYLAN PHARMS INC
AB
AB ROXANE
AB
AB WATSON LABS
AB
TRIENTINE HYDROCHLORIDE
CAPSULE;ORAL
SYPRINE
+ ATON
TRIFLUOPERAZINE HYDROCHLORIDE
TABLET;ORAL
TRIFLUOPERAZINE HYDROCHLORIDE
50MG
100MG
0.125MG
0.25MG
0.125MG
0.25MG
0.125MG
0.25MG
0.125MG
0.25MG
250MG
AB MYLAN
AB
AB
AB +
AB SANDOZ
AB
AB
AB
TRIFLURIDINE
SOLUTION/DROPS;OPHTHALMIC
TRIFLURIDINE
AT ALCON PHARMS LTD
VIROPTIC
AT + MONARCH PHARMS
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
1%
1%
TRIHEXYPHENIDYL HYDROCHLORIDE
ELIXIR;ORAL
TRIHEXYPHENIDYL HYDROCHLORIDE
AA MIKART 2MG/5ML
AA + PHARM ASSOC 2MG/5ML
TABLET;ORAL
TRIHEXYPHENIDYL HYDROCHLORIDE
AA NATCO PHARMA LTD
AA
AA VINTAGE PHARMS
AA
AA WATSON LABS
AA +
AA
AA +
TRIMETHADIONE
TABLET;ORAL
TRIDIONE
+ ABBVIE
2MG
5MG
2MG
5MG
2MG
2MG
5MG
5MG
150MG
TRIMETHOBENZAMIDE HYDROCHLORIDE
CAPSULE;ORAL
TIGAN
AB + KING PHARMS 300MG
TRIMETHOBENZAMIDE HYDROCHLORIDE
AB GAVIS PHARMS 300MG
AB MUTUAL PHARMA 300MG
INJECTABLE;INJECTION
TIGAN
AP + JHP PHARMS 100MG/ML
3-348( of 362)
N013174 001
N013174 002
N017892 003 Apr 26, 1985
N017892 001 Nov 15, 1982
A074031 001 Mar 25, 1994
A074031 002 Mar 25, 1994
A074224 001 Jun 01, 1994
A074224 002 Jun 01, 1994
A074445 001 Oct 20, 1995
A074445 002 Oct 20, 1995
N019194 001 Nov 08, 1985
A040209 001 Jul 07, 1997
A040209 002 Jul 07, 1997
A040209 003 Jul 07, 1997
A040209 004 Jul 07, 1997
A085785 001
A085786 001
A085789 001
A085788 001
A074311 001 Oct 06, 1995
N018299 001
A040251 001 Sep 27, 1999
A040177 001 Apr 17, 1997
A091630 001 Nov 17, 2010
A091630 002 Nov 17, 2010
A040254 001 Dec 24, 1998
A040254 002 Dec 24, 1998
A040184 001 Feb 06, 1998
A084363 001
A040184 002 Feb 06, 1998
A084364 001
N005856 009
N017531 006 Dec 13, 2001
A076546 001 Aug 20, 2003
A076570 001 Aug 28, 2003
N017530 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-349( of 362)
TRIMETHOBENZAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
TRIMETHOBENZAMIDE HYDROCHLORIDE
AP LUITPOLD 100MG/ML A091330 001 Mar 08, 2011
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE
AP LUITPOLD 100MG/ML A091329 001 Mar 08, 2011
TRIMETHOPRIM
TABLET;ORAL
TRIMETHOPRIM
AB NOVEL LABS INC 100MG A091437 001 Jun 15, 2011
AB + TEVA 100MG N018679 001 Jul 30, 1982
AB WATSON LABS 100MG A070049 001 Jun 06, 1985
TRIMETHOPRIM HYDROCHLORIDE
SOLUTION;ORAL
PRIMSOL
+ FSC EQ 50MG BASE/5ML N074973 001 Jan 24, 2000
TRIMIPRAMINE MALEATE
CAPSULE;ORAL
SURMONTIL
AB ODYSSEY PHARMS EQ 25MG BASE N016792 001
AB EQ 50MG BASE N016792 002
AB + EQ 100MG BASE N016792 003 Sep 15, 1982
TRIMIPRAMINE MALEATE
AB MIKAH PHARMA EQ 25MG BASE A077361 001 Aug 02, 2006
AB EQ 50MG BASE A077361 002 Aug 02, 2006
AB EQ 100MG BASE A077361 003 Aug 02, 2006
TRIPTORELIN PAMOATE
INJECTABLE;INTRAMUSCULAR
TRELSTAR
+ WATSON LABS EQ 3.75MG BASE/VIAL N020715 001 Jun 15, 2000
+ EQ 11.25MG BASE/VIAL N021288 001 Jun 29, 2001
+ EQ 22.5MG BASE/VIAL N022437 001 Mar 10, 2010
TROMETHAMINE
INJECTABLE;INJECTION
THAM
+ HOSPIRA 3.6GM/100ML N013025 002
TROPICAMIDE
SOLUTION/DROPS;OPHTHALMIC
MYDRIACYL
AT + ALCON 0.5% A084305 001
AT + 1% A084306 001
TROPICACYL
AT AKORN 0.5% A040314 001 Sep 29, 2000
AT 1% A040315 001 Sep 29, 2000
TROPICAMIDE
AT BAUSCH AND LOMB 0.5% A040067 001 Jul 27, 1994
AT 1% A040064 001 Jul 27, 1994
TROSPIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
SANCTURA XR
AB + ALLERGAN 60MG N022103 001 Aug 03, 2007
TROSPIUM CHLORIDE
AB PADDOCK LLC 60MG A201291 001 May 24, 2013
AB WATSON LABS INC FL 60MG A091289 001 Oct 12, 2012
TABLET;ORAL
SANCTURA
AB + ALLERGAN 20MG N021595 001 May 28, 2004
TROSPIUM CHLORIDE
AB APOTEX 20MG A091513 001 Dec 06, 2011
AB GLENMARK GENERICS 20MG A091575 001 Aug 13, 2010
AB PADDOCK LLC 20MG A091573 001 Nov 17, 2010
TRYPAN BLUE
SOLUTION;OPHTHALMIC
MEMBRANEBLUE
+ DORC 0.15% N022278 001 Feb 20, 2009
VISIONBLUE
+ DORC 0.06% N021670 001 Dec 16, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-350( of 362)
ULIPRISTAL ACETATE
TABLET;ORAL
ELLA
+ LAB HRA PHARMA 30MG N022474 001 Aug 13, 2010
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
POWDER;INHALATION
ANORO ELLIPTA
+ GLAXO GRP LTD EQ 0.0625MG BASE/INH;EQ 0.025MG N203975 001 Dec 18, 2013
BASE/INH
UNOPROSTONE ISOPROPYL
SOLUTION/DROPS;OPHTHALMIC
RESCULA
SUCAMPO PHARMS 0.15% N021214 001 Aug 03, 2000
UREA C-13
FOR SOLUTION;ORAL
BREATHTEK UBT FOR H-PYLORI
+ OTSUKA AMERICA EQ 75MG /POUCH N020586 002 May 10, 2001
UREA, C-14
CAPSULE;ORAL
PYTEST
+ AVENT 1uCi N020617 001 May 09, 1997
PYTEST KIT
+ AVENT 1uCi N020617 002 May 09, 1997
UROFOLLITROPIN
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
BRAVELLE
+ FERRING 75 IU/VIAL N021289 001 May 06, 2002
URSODIOL
CAPSULE;ORAL
ACTIGALL
AB + WATSON PHARMS 300MG N019594 002 Dec 31, 1987
URSODIOL
AB COREPHARMA 300MG A077895 001 Jul 27, 2006
AB EPIC PHARMA 300MG A075517 001 Mar 14, 2000
AB LANNETT 300MG A079082 001 Dec 15, 2008
AB MYLAN 300MG A090530 001 Feb 17, 2010
AB TEVA PHARMS 300MG A075592 001 May 25, 2000
TABLET;ORAL
URSO 250
AB APTALIS PHARMA US 250MG N020675 001 Dec 10, 1997
URSO FORTE
AB + APTALIS PHARMA US 500MG N020675 002 Jul 21, 2004
URSODIOL
AB GLENMARK GENERICS 250MG A090801 001 Jul 12, 2011
AB 500MG A090801 002 Jul 12, 2011
AB PAR PHARM 250MG A202540 001 Feb 14, 2013
AB 500MG A202540 002 Feb 14, 2013
AB WATSON LABS INC 250MG A200826 001 Dec 23, 2011
AB 500MG A200826 002 Dec 23, 2011
VALACYCLOVIR HYDROCHLORIDE
TABLET;ORAL
VALACYCLOVIR HYDROCHLORIDE
AB ACTAVIS GRP PTC EQ 1GM BASE A090370 002 Mar 16, 2011
AB EQ 500MG BASE A090370 001 Mar 16, 2011
AB AUROBINDO PHARMA EQ 1GM BASE A090682 002 May 24, 2010
AB EQ 500MG BASE A090682 001 May 24, 2010
AB DR REDDYS LABS LTD EQ 1GM BASE A079012 002 May 24, 2010
AB EQ 500MG BASE A079012 001 May 24, 2010
AB JUBILANT ORGANOSYS EQ 1GM BASE A201506 002 Apr 03, 2012
AB EQ 500MG BASE A201506 001 Apr 03, 2012
AB MYLAN EQ 1GM BASE A078070 002 May 24, 2010
AB EQ 500MG BASE A078070 001 May 24, 2010
AB MYLAN PHARMS INC EQ 1GM BASE A078518 002 May 24, 2010
AB EQ 500MG BASE A078518 001 May 24, 2010
AB RANBAXY EQ 1GM BASE A076588 002 Jan 31, 2007
AB EQ 500MG BASE A076588 001 Jan 31, 2007
AB ROXANE EQ 1GM BASE A078656 002 May 24, 2010
AB EQ 500MG BASE A078656 001 May 24, 2010
AB SANDOZ EQ 1GM BASE A077478 002 May 24, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-351( of 362)
VALACYCLOVIR HYDROCHLORIDE
TABLET;ORAL
VALACYCLOVIR HYDROCHLORIDE
AB EQ 500MG BASE A077478 001 May 24, 2010
AB TEVA PHARMS EQ 1GM BASE A077655 002 May 24, 2010
AB EQ 500MG BASE A077655 001 May 24, 2010
AB WATSON LABS EQ 1GM BASE A077135 002 May 24, 2010
AB EQ 500MG BASE A077135 001 May 24, 2010
AB WOCKHARDT EQ 1GM BASE A090216 002 May 24, 2010
AB EQ 500MG BASE A090216 001 May 24, 2010
VALTREX
AB + GLAXOSMITHKLINE EQ 1GM BASE N020487 002 Jun 23, 1995
AB EQ 500MG BASE N020487 001 Jun 23, 1995
VALGANCICLOVIR HYDROCHLORIDE
FOR SOLUTION;ORAL
VALCYTE
+ HOFFMANN LA ROCHE 50MG/ML N022257 001 Aug 28, 2009
TABLET;ORAL
VALCYTE
+ HOFFMANN LA ROCHE EQ 450MG BASE N021304 001 Mar 29, 2001
VALPROATE SODIUM
INJECTABLE;INJECTION
DEPACON
AP + ABBVIE EQ 100MG BASE/ML N020593 001 Dec 30, 1996
VALPROATE SODIUM
AP BEDFORD EQ 100MG BASE/ML A076295 001 Nov 14, 2002
AP FRESENIUS KABI USA EQ 100MG BASE/ML A076539 001 Jun 26, 2003
AP HIKMA FARMACEUTICA EQ 100MG BASE/ML A078523 001 Feb 17, 2010
VALPROIC ACID
CAPSULE;ORAL
DEPAKENE
AB + ABBVIE 250MG N018081 001
VALPROIC ACID
AB BANNER PHARMACAPS 250MG A073484 001 Jun 29, 1993
AB CATALENT 250MG A073229 001 Oct 29, 1991
AB SUN PHARM INDS LTD 250MG A091037 001 Feb 22, 2013
SYRUP;ORAL
DEPAKENE
AA + ABBVIE 250MG/5ML N018082 001
VALPROIC ACID
AA ALPHARMA 250MG/5ML A075782 001 Dec 22, 2000
AA HIGH TECH PHARMA 250MG/5ML A074060 001 Jan 13, 1995
AA PHARM ASSOC 250MG/5ML A075379 001 Dec 15, 2000
AA SUN PHARM INDS INC 250MG/5ML A090517 001 May 28, 2010
AA TEVA PHARMS 250MG/5ML A073178 001 Aug 25, 1992
AA VINTAGE 250MG/5ML A077960 001 Oct 13, 2006
AA WOCKHARDT 250MG/5ML A070868 001 Jul 01, 1986
VALRUBICIN
SOLUTION;INTRAVESICAL
VALSTAR PRESERVATIVE FREE
+ ENDO PHARM 40MG/ML N020892 001 Sep 25, 1998
VALSARTAN
TABLET;ORAL
DIOVAN
NOVARTIS 40MG N021283 004 Aug 14, 2002
80MG N021283 001 Jul 18, 2001
160MG N021283 002 Jul 18, 2001
+ 320MG N021283 003 Jul 18, 2001
VANCOMYCIN HYDROCHLORIDE
CAPSULE;ORAL
VANCOCIN HYDROCHLORIDE
AB VIROPHARMA EQ 125MG BASE N050606 001 Apr 15, 1986
AB + EQ 250MG BASE N050606 002 Apr 15, 1986
VANCOMYCIN HYDROCHLORIDE
AB AKORN EQ 125MG BASE A065478 001 Apr 09, 2012
AB EQ 250MG BASE A065478 002 Apr 09, 2012
AB FRESENIUS KABI USA EQ 125MG BASE A065453 001 Jun 18, 2012
AB EQ 250MG BASE A065453 002 Jun 18, 2012
AB STRIDES ARCOLAB LTD EQ 125MG BASE A065490 001 Apr 09, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-352( of 362)
VANCOMYCIN HYDROCHLORIDE
CAPSULE;ORAL
VANCOMYCIN HYDROCHLORIDE
AB EQ 250MG BASE A065490 002 Apr 09, 2012
AB WATSON LABS EQ 125MG BASE A065510 001 Apr 09, 2012
AB EQ 250MG BASE A065510 002 Apr 09, 2012
INJECTABLE;INJECTION
VANCOMYCIN HYDROCHLORIDE
AP AGILA SPECLTS EQ 1GM BASE/VIAL A065397 002 Dec 30, 2008
AP EQ 5GM BASE/VIAL A065432 001 Dec 30, 2008
AP EQ 10GM BASE/VIAL A091469 001 Jul 01, 2011
AP EQ 500MG BASE/VIAL A065397 001 Dec 30, 2008
AP EMCURE PHARMS LTD EQ 1GM BASE/VIAL A202275 002 Oct 31, 2013
AP EQ 10GM BASE/VIAL A202464 001 Oct 09, 2013
AP EQ 5GM BASE/VIAL A202274 001 Oct 31, 2013
AP EQ 500MG BASE/VIAL A202275 001 Oct 31, 2013
AP + FRESENIUS KABI USA EQ 1GM BASE/VIAL A062663 002 Jul 31, 1987
AP + EQ 5GM BASE/VIAL A062663 003 Jun 03, 1988
AP + EQ 10GM BASE/VIAL A062663 004 Nov 28, 1997
AP + EQ 500MG BASE/VIAL A062663 001 Mar 17, 1987
AP + HOSPIRA EQ 1GM BASE/VIAL A062912 001 Aug 04, 1988
AP + EQ 1GM BASE/VIAL A062933 001 Oct 29, 1992
AP + EQ 5GM BASE/VIAL A063076 001 Dec 21, 1990
AP + EQ 500MG BASE/VIAL A062911 001 Aug 04, 1988
AP + EQ 500MG BASE/VIAL A062931 001 Oct 29, 1992
AP EQ 750MG BASE/VIAL A062912 002 Jan 07, 2009
AP EQ 750MG BASE/VIAL A062933 002 May 27, 2009
AP HOSPIRA INC EQ 10GM BASE/VIAL A065455 001 Apr 29, 2009
AP MYLAN INSTITUTIONAL EQ 1GM BASE/VIAL A065401 002 Jun 30, 2008
AP EQ 500MG BASE/VIAL A065401 001 Jun 30, 2008
AP SAGENT PHARMS EQ 5GM BASE/VIAL A200837 001 Aug 10, 2012
AP SANDOZ EQ 1GM BASE/VIAL A090250 002 Apr 27, 2010
AP EQ 500MG BASE/VIAL A090250 001 Apr 27, 2010
AP SANDOZ INC EQ 5GM BASE/VIAL A201048 001 Aug 10, 2012
AP EQ 10GM BASE/VIAL A201048 002 Aug 10, 2012
AP STRIDES ARCOLAB LTD EQ 10GM BASE/VIAL A091554 001 Sep 19, 2011
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER
+ BAXTER HLTHCARE EQ 500MG BASE/100ML N050671 001 Apr 29, 1993
+ EQ 750MG BASE/150ML N050671 002 Dec 20, 2010
VANDETANIB
TABLET;ORAL
CAPRELSA
IPR PHARMS INC 100MG N022405 001 Apr 06, 2011
+ 300MG N022405 002 Apr 06, 2011
VARDENAFIL HYDROCHLORIDE
TABLET;ORAL
LEVITRA
AB BAYER HLTHCARE 2.5MG N021400 003 Aug 19, 2003
AB 5MG N021400 001 Aug 19, 2003
AB 10MG N021400 002 Aug 19, 2003
AB + 20MG N021400 004 Aug 19, 2003
VARDENAFIL HYDROCHLORIDE
AB TEVA PHARMS 2.5MG A091347 001 May 03, 2012
AB 5MG A091347 002 May 03, 2012
AB 10MG A091347 003 May 03, 2012
AB 20MG A091347 004 May 03, 2012
TABLET, ORALLY DISINTEGRATING;ORAL
STAXYN
+ BAYER HLTHCARE 10MG N200179 001 Jun 17, 2010
VARENICLINE TARTRATE
TABLET;ORAL
CHANTIX
PFIZER INC EQ 0.5MG BASE N021928 001 May 10, 2006
+ EQ 1MG BASE N021928 002 May 10, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-353( of 362)
VECURONIUM BROMIDE
INJECTABLE;INJECTION
VECURONIUM BROMIDE
AP AGILA SPECLTS 10MG/VIAL A090243 001 May 11, 2010
AP 20MG/VIAL A090243 002 May 11, 2010
AP BEDFORD 10MG/VIAL A075549 001 Jun 13, 2000
AP 20MG/VIAL A075549 002 Jun 13, 2000
AP HOSPIRA 10MG/VIAL A075164 001 Oct 21, 1999
AP 20MG/VIAL A075164 002 Oct 21, 1999
AP MUSTAFA NEVZAT 10MG/VIAL A078274 001 Dec 29, 2008
AP 20MG/VIAL A078274 002 Dec 29, 2008
AP + SUN PHARMA GLOBAL 10MG/VIAL A079001 001 Jun 17, 2009
AP + 20MG/VIAL A079001 002 Jun 17, 2009
AP TEVA PHARMS USA 10MG/VIAL A074688 001 Aug 25, 1999
AP 20MG/VIAL A074688 002 Aug 25, 1999
AP WATSON LABS 10MG/VIAL A074334 001 Aug 31, 1995
AP 20MG/VIAL A074334 002 Aug 31, 1995
VELAGLUCERASE ALFA
INJECTABLE;IV (INFUSION)
VPRIV
SHIRE HUMAN GENETIC 400 UNITS/VIAL N022575 001 Feb 26, 2010
VEMURAFENIB
TABLET;ORAL
ZELBORAF
+ HOFFMANN LA ROCHE 240MG N202429 001 Aug 17, 2011
VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
EFFEXOR XR
AB WYETH PHARMS INC EQ 37.5MG BASE N020699 001 Oct 20, 1997
AB EQ 75MG BASE N020699 002 Oct 20, 1997
AB + EQ 150MG BASE N020699 004 Oct 20, 1997
VENLAFAXINE HYDROCHLORIDE
AB ANCHEN PHARMS EQ 37.5MG BASE A078087 001 Mar 16, 2012
AB EQ 75MG BASE A078087 002 Mar 16, 2012
AB EQ 150MG BASE A078087 003 Mar 16, 2012
AB AUROBINDO PHARMA LTD EQ 37.5MG BASE A200834 001 Apr 14, 2011
AB EQ 75MG BASE A200834 002 Apr 14, 2011
AB EQ 150MG BASE A200834 003 Apr 14, 2011
AB DR REDDYS LABS LTD EQ 37.5MG BASE A078421 001 May 06, 2011
AB EQ 75MG BASE A078421 002 May 06, 2011
AB EQ 150MG BASE A078421 003 May 06, 2011
AB MYLAN EQ 37.5MG BASE A078789 001 Jun 01, 2011
AB EQ 75MG BASE A078789 002 Jun 01, 2011
AB EQ 150MG BASE A078789 003 Jun 01, 2011
AB ORCHID HLTHCARE EQ 37.5MG BASE A091123 001 Jul 11, 2011
AB EQ 75MG BASE A091123 002 Jul 11, 2011
AB EQ 150MG BASE A091123 003 Jul 11, 2011
AB TEVA EQ 37.5MG BASE A076565 001 Jun 28, 2010
AB EQ 75MG BASE A076565 002 Jun 28, 2010
AB EQ 150MG BASE A076565 003 Jun 28, 2010
AB TORRENT PHARMS LLC EQ 37.5MG BASE A090899 001 Jun 01, 2011
AB EQ 75MG BASE A090899 002 Jun 01, 2011
AB EQ 150MG BASE A090899 003 Jun 01, 2011
AB VALEANT BERMUDA EQ 37.5MG BASE A090071 001 Apr 15, 2011
AB EQ 75MG BASE A090071 002 Apr 15, 2011
AB EQ 150MG BASE A090071 003 Apr 15, 2011
AB WOCKHARDT EQ 37.5MG BASE A078865 001 Apr 14, 2011
AB EQ 75MG BASE A078865 002 Apr 14, 2011
AB EQ 150MG BASE A078865 003 Apr 14, 2011
AB ZYDUS PHARMS USA INC EQ 37.5MG BASE A090174 001 Apr 14, 2011
AB EQ 75MG BASE A090174 002 Apr 14, 2011
AB EQ 150MG BASE A090174 003 Apr 14, 2011
TABLET;ORAL
VENLAFAXINE HYDROCHLORIDE
AB ALEMBIC PHARMS LTD EQ 25MG BASE A078932 001 Dec 14, 2010
AB EQ 37.5MG BASE A078932 002 Dec 14, 2010
AB EQ 50MG BASE A078932 003 Dec 14, 2010
AB EQ 75MG BASE A078932 004 Dec 14, 2010
AB EQ 100MG BASE A078932 005 Dec 14, 2010
AB AMNEAL PHARMS EQ 25MG BASE A079098 001 May 11, 2010
AB EQ 37.5MG BASE A079098 002 May 11, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
VENLAFAXINE HYDROCHLORIDE
TABLET;ORAL
VENLAFAXINE HYDROCHLORIDE
AB
AB
AB
AB AUROBINDO PHARMA
AB
AB
AB
AB
AB CARACO
AB
AB
AB
AB
AB DR REDDYS LABS LTD
AB
AB
AB
AB
AB HERITAGE PHARMS INC
AB
AB
AB
AB
AB MYLAN
AB
AB
AB
AB
AB TEVA
AB
AB +
AB
AB
AB VINTAGE
AB
AB
AB
AB
AB ZYDUS PHARMS USA
AB
AB
AB
AB
TABLET, EXTENDED RELEASE;ORAL
VENLAFAXINE HYDROCHLORIDE
AB OSMOTICA PHARM
AB
AB +
AB SUN PHARMA GLOBAL
AB
AB
OSMOTICA PHARM
VERAPAMIL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
VERAPAMIL HYDROCHLORIDE
AB MYLAN
AB
AB
AB
AB
AB
VERELAN
AB ALKERMES GAINESVILLE
AB
AB
VERELAN PM
AB ALKERMES GAINESVILLE
AB
AB +
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 225MG BASE
100MG
120MG
180MG
200MG
240MG
300MG
120MG
180MG
240MG
100MG
200MG
300MG
3-354( of 362)
A079098 003 May 11, 2010
A079098 004 May 11, 2010
A079098 005 May 11, 2010
A090555 001 Apr 07, 2010
A090555 002 Apr 07, 2010
A090555 003 Apr 07, 2010
A090555 004 Apr 07, 2010
A090555 005 Apr 07, 2010
A078627 001 Jun 13, 2008
A078627 002 Jun 13, 2008
A078627 003 Jun 13, 2008
A078627 004 Jun 13, 2008
A078627 005 Jun 13, 2008
A078301 001 Jun 13, 2008
A078301 002 Jun 13, 2008
A078301 003 Jun 13, 2008
A078301 004 Jun 13, 2008
A078301 005 Jun 13, 2008
A078554 001 Jan 09, 2009
A078554 002 Jan 09, 2009
A078554 003 Jan 09, 2009
A078554 004 Jan 09, 2009
A078554 005 Jan 09, 2009
A077166 001 Jun 13, 2008
A077166 002 Jun 13, 2008
A077166 003 Jun 13, 2008
A077166 004 Jun 13, 2008
A077166 005 Jun 13, 2008
A076690 001 Aug 03, 2006
A076690 002 Aug 03, 2006
A076690 003 Aug 03, 2006
A076690 004 Aug 03, 2006
A076690 005 Aug 03, 2006
A090027 001 Aug 04, 2010
A090027 002 Aug 04, 2010
A090027 003 Aug 04, 2010
A090027 004 Aug 04, 2010
A090027 005 Aug 04, 2010
A077653 001 Jun 13, 2008
A077653 002 Jun 13, 2008
A077653 003 Jun 13, 2008
A077653 004 Jun 13, 2008
A077653 005 Jun 13, 2008
N022104 001 May 20, 2008
N022104 002 May 20, 2008
N022104 003 May 20, 2008
A091272 001 Aug 18, 2010
A091272 002 Aug 18, 2010
A091272 003 Aug 18, 2010
N022104 004 May 20, 2008
A078306 001 Aug 09, 2007
A075138 001 Apr 20, 1999
A075138 002 Apr 20, 1999
A078306 002 Aug 09, 2007
A075138 003 Apr 20, 1999
A078306 003 Aug 09, 2007
N019614 001 May 29, 1990
N019614 003 Jan 09, 1992
N019614 002 May 29, 1990
N020943 001 Nov 25, 1998
N020943 002 Nov 25, 1998
N020943 003 Nov 25, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-355( of 362)
VERAPAMIL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
VERELAN
+ ALKERMES GAINESVILLE 360MG N019614 004 May 10, 1996
INJECTABLE;INJECTION
VERAPAMIL HYDROCHLORIDE
AP HOSPIRA 2.5MG/ML A070737 001 May 06, 1987
AP 2.5MG/ML A070738 001 May 06, 1987
AP 2.5MG/ML A075136 001 Oct 20, 1998
TABLET;ORAL
CALAN
AB GD SEARLE LLC 40MG N018817 003 Feb 23, 1988
AB 80MG N018817 001 Sep 10, 1984
AB + 120MG N018817 002 Sep 10, 1984
VERAPAMIL HYDROCHLORIDE
AB HERITAGE PHARMS INC 80MG A071880 001 Apr 05, 1988
AB 120MG A071881 001 Apr 05, 1988
AB MYLAN 80MG A071482 001 Feb 15, 1989
AB 120MG A071483 001 Feb 15, 1989
AB WATSON LABS 40MG A072923 001 Jun 29, 1993
AB 40MG A072924 001 Jun 29, 1993
AB 80MG A070855 001 Sep 24, 1986
AB 80MG A070995 001 Oct 01, 1986
AB 80MG A071366 001 Oct 01, 1986
AB 120MG A070856 001 Sep 24, 1986
AB 120MG A070994 001 Oct 01, 1986
AB 120MG A071367 001 Oct 01, 1986
TABLET, EXTENDED RELEASE;ORAL
CALAN SR
AB + PFIZER 120MG N019152 003 Mar 06, 1991
AB + 180MG N019152 002 Dec 15, 1989
AB + 240MG N019152 001 Dec 16, 1986
VERAPAMIL HYDROCHLORIDE
AB APOTEX CORP 120MG A200878 001 Apr 20, 2012
AB 180MG A200878 002 Apr 20, 2012
AB 240MG A200878 003 Apr 20, 2012
AB CARACO 120MG A090529 001 Dec 30, 2011
AB 180MG A090529 002 Dec 30, 2011
AB 240MG A090529 003 Dec 30, 2011
AB GLENMARK GENERICS 120MG A090700 001 Aug 03, 2011
AB 180MG A090700 002 Aug 03, 2011
AB 240MG A078906 001 Sep 17, 2009
AB IVAX SUB TEVA PHARMS 120MG A073568 002 Oct 10, 1997
AB 180MG A074330 001 Jan 31, 1994
AB 240MG A073568 001 Jul 31, 1992
AB MYLAN 120MG A074587 002 Feb 21, 1997
AB 180MG A074587 003 Sep 09, 1997
AB 240MG A074587 001 Mar 23, 1996
AB PAR PHARM 120MG A075072 001 May 25, 1999
AB 240MG A075072 003 May 25, 1999
COVERA-HS
BC + GD SEARLE LLC 180MG N020552 001 Feb 26, 1996
BC + 240MG N020552 002 Feb 26, 1996
VERTEPORFIN
INJECTABLE;INJECTION
VISUDYNE
+ VALEANT PHARMS INC 15MG/VIAL N021119 001 Apr 12, 2000
VIGABATRIN
FOR SOLUTION;ORAL
SABRIL
+ LUNDBECK LLC 500MG/PACKET N022006 001 Aug 21, 2009
TABLET;ORAL
SABRIL
+ LUNDBECK LLC 500MG N020427 001 Aug 21, 2009
VILAZODONE HYDROCHLORIDE
TABLET;ORAL
VIIBRYD
+ FOREST LABS INC 10MG N022567 001 Jan 21, 2011
20MG N022567 002 Jan 21, 2011
40MG N022567 003 Jan 21, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-356( of 362)
VINBLASTINE SULFATE
INJECTABLE;INJECTION
VINBLASTINE SULFATE
+ BEDFORD 10MG/VIAL A089395 001 Apr 09, 1987
+ FRESENIUS KABI USA 1MG/ML A089515 001 Apr 29, 1987
VINCRISTINE SULFATE
INJECTABLE;INJECTION
VINCRISTINE SULFATE PFS
AP + HOSPIRA 1MG/ML A071484 001 Apr 19, 1988
AP TEVA PHARMS USA 1MG/ML A075493 001 Sep 01, 1999
INJECTABLE, LIPOSOMAL;INTRAVENOUS
MARQIBO KIT
+ TALON THERAP 5MG/5ML (1MG/ML) N202497 001 Aug 09, 2012
VINORELBINE
INJECTABLE;INJECTION
VINORELBINE
AP ONCO THERAPIES LTD EQ 10MG BASE/ML A200148 001 Aug 31, 2012
VINORELBINE TARTRATE
INJECTABLE;INJECTION
NAVELBINE
AP + PIERRE FABRE EQ 10MG BASE/ML N020388 001 Dec 23, 1994
VINORELBINE TARTRATE
AP ACTAVIS TOTOWA EQ 10MG BASE/ML A078011 001 Jul 22, 2009
AP BEDFORD EQ 10MG BASE/ML A076461 001 Dec 11, 2003
AP DR REDDYS LABS LTD EQ 10MG BASE/ML A202017 001 Sep 12, 2013
AP EBEWE PHARMA EQ 10MG BASE/ML A078408 001 Feb 13, 2008
AP FRESENIUS KABI USA EQ 10MG BASE/ML A076849 001 Apr 18, 2005
AP HIKMA MAPLE EQ 10MG BASE/ML A075992 001 Jun 10, 2003
AP HOSPIRA EQ 10MG BASE/ML A076827 001 Jun 02, 2005
AP JIANGSU HANSOH PHARM EQ 10MG BASE/ML A091106 001 Sep 26, 2012
AP TEVA PHARMS USA EQ 10MG BASE/ML A076028 001 Feb 03, 2003
VISMODEGIB
CAPSULE;ORAL
ERIVEDGE
+ GENENTECH 150MG N203388 001 Jan 30, 2012
VITAMIN A PALMITATE
INJECTABLE;INJECTION
AQUASOL A
+ HOSPIRA EQ 50,000 UNITS BASE/ML N006823 001
VORICONAZOLE
FOR SUSPENSION;ORAL
VFEND
AB + PFIZER 200MG/5ML N021630 001 Dec 19, 2003
VORICONAZOLE
AB MYLAN PHARMS INC 200MG/5ML A202361 001 May 28, 2013
INJECTABLE;IV (INFUSION)
VFEND
AP + PFIZER 200MG/VIAL N021267 001 May 24, 2002
VORICONAZOLE
AP SANDOZ INC 200MG/VIAL A090862 001 May 30, 2012
TABLET;ORAL
VFEND
AB PFIZER 50MG N021266 001 May 24, 2002
AB + 200MG N021266 002 May 24, 2002
VORICONAZOLE
AB MYLAN PHARMS INC 50MG A090547 001 Apr 22, 2010
AB 200MG A090547 002 Apr 22, 2010
AB SANDOZ INC 50MG A200265 001 Dec 12, 2011
AB 200MG A200265 002 Dec 12, 2011
AB TEVA PHARMS 50MG A091658 001 Apr 06, 2012
AB 200MG A091658 002 Apr 06, 2012
VORINOSTAT
CAPSULE;ORAL
ZOLINZA
+ MERCK 100MG N021991 001 Oct 06, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
VORTIOXETINE HYDROBROMIDE
TABLET;ORAL
BRINTELLIX
TAKEDA PHARMS USA EQ 5MG BASE
EQ 10MG BASE
EQ 15MG BASE
+ EQ 20MG BASE
WARFARIN SODIUM
INJECTABLE;INJECTION
COUMADIN
+ BRISTOL MYERS SQUIBB 5MG/VIAL
TABLET;ORAL
COUMADIN
AB
AB
BRISTOL MYERS SQUIBB 1MG
2MG
AB 2.5MG
AB 3MG
AB 4MG
AB 5MG
AB 6MG
AB 7.5MG
AB + 10MG
JANTOVEN
AB USL PHARMA 1MG
AB 2MG
AB 2.5MG
AB 3MG
AB 4MG
AB 5MG
AB 6MG
AB 7.5MG
AB 10MG
WARFARIN SODIUM
AB AMNEAL PHARMS 1MG
AB 2MG
AB 2.5MG
AB 3MG
AB 4MG
AB 5MG
AB 6MG
AB 7.5MG
AB 10MG
AB BARR 1MG
AB 2MG
AB 2.5MG
AB 3MG
AB 4MG
AB 5MG
AB 6MG
AB 7.5MG
AB 10MG
AB INVAGEN PHARMS 1MG
AB 2MG
AB 2.5MG
AB 3MG
AB 4MG
AB 5MG
AB 6MG
AB 7.5MG
AB 10MG
AB IPCA LABS LTD 1MG
AB 2MG
AB 2.5MG
AB 3MG
AB 4MG
AB 5MG
AB 6MG
AB 7.5MG
AB 10MG
AB MYLAN 1MG
AB 2MG
AB 2.5MG
3-357( of 362)
N204447 001 Sep 30, 2013
N204447 002 Sep 30, 2013
N204447 003 Sep 30, 2013
N204447 004 Sep 30, 2013
N009218 024 Feb 07, 1995
N009218 022 Mar 01, 1990
N009218 013
N009218 018
N009218 025 Nov 18, 1996
N009218 023 Aug 24, 1993
N009218 007
N009218 026 Nov 18, 1996
N009218 016
N009218 005
A040416 001 Oct 02, 2003
A040416 002 Oct 02, 2003
A040416 003 Oct 02, 2003
A040416 004 Oct 02, 2003
A040416 005 Oct 02, 2003
A040416 006 Oct 02, 2003
A040416 007 Oct 02, 2003
A040416 008 Oct 02, 2003
A040416 009 Oct 02, 2003
A202202 001 Mar 04, 2013
A202202 002 Mar 04, 2013
A202202 003 Mar 04, 2013
A202202 004 Mar 04, 2013
A202202 005 Mar 04, 2013
A202202 006 Mar 04, 2013
A202202 007 Mar 04, 2013
A202202 008 Mar 04, 2013
A202202 009 Mar 04, 2013
A040145 001 Mar 26, 1997
A040145 002 Mar 26, 1997
A040145 003 Mar 26, 1997
A040145 008 Nov 05, 1998
A040145 004 Mar 26, 1997
A040145 005 Mar 26, 1997
A040145 009 Nov 05, 1998
A040145 006 Mar 26, 1997
A040145 007 Mar 26, 1997
A090935 001 May 25, 2011
A090935 002 May 25, 2011
A090935 003 May 25, 2011
A090935 004 May 25, 2011
A090935 005 May 25, 2011
A090935 006 May 25, 2011
A090935 007 May 25, 2011
A090935 008 May 25, 2011
A090935 009 May 25, 2011
A200104 001 Jun 27, 2013
A200104 002 Jun 27, 2013
A200104 003 Jun 27, 2013
A200104 004 Jun 27, 2013
A200104 005 Jun 27, 2013
A200104 006 Jun 27, 2013
A200104 007 Jun 27, 2013
A200104 008 Jun 27, 2013
A200104 009 Jun 27, 2013
A040415 001 Sep 27, 2004
A040415 002 Sep 27, 2004
A040415 003 Sep 29, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
WARFARIN SODIUM
TABLET;ORAL
WARFARIN SODIUM
AB 3MG
AB 4MG
AB 5MG
AB 6MG
AB 7.5MG
AB 10MG
AB PLIVA 1MG
AB 2MG
AB 2.5MG
AB 3MG
AB 4MG
AB 5MG
AB 6MG
AB 7.5MG
AB 10MG
AB TARO 1MG
AB 2MG
AB 2.5MG
AB 3MG
AB 4MG
AB 5MG
AB 6MG
AB 7.5MG
AB 10MG
AB ZYDUS PHARMS USA 1MG
AB 2MG
AB 2.5MG
AB 3MG
AB 4MG
AB 5MG
AB 6MG
AB 7.5MG
AB 10MG
XENON XE-133
GAS;INHALATION
XENON XE 133
AA LANTHEUS MEDCL 20mCi/VIAL
10mCi/VIAL
ZAFIRLUKAST
TABLET;ORAL
ACCOLATE
AB ASTRAZENECA 10MG
AB + 20MG
ZAFIRLUKAST
AB DR REDDYS LABS LTD 10MG
AB 20MG
ZALEPLON
CAPSULE;ORAL
SONATA
AB PFIZER 5MG
AB + 10MG
ZALEPLON
AB AUROBINDO PHARMA 5MG
AB 10MG
AB CIPLA LTD 5MG
AB 10MG
AB MYLAN 5MG
AB 10MG
AB ORCHID HLTHCARE 5MG
AB 10MG
AB ROXANE 5MG
AB 10MG
AB TEVA PHARMS 5MG
AB 10MG
AB UNICHEM 5MG
AB 10MG
AB UPSHER SMITH 5MG
AB 10MG
3-358( of 362)
A040415 004 Sep 27, 2004
A040415 005 Sep 27, 2004
A040415 006 Sep 27, 2004
A040415 007 Sep 27, 2004
A040415 008 Sep 27, 2004
A040415 009 Sep 27, 2004
A040616 009 Jul 05, 2006
A040616 001 Jul 05, 2006
A040616 002 Jul 05, 2006
A040616 003 Jul 05, 2006
A040616 004 Jul 05, 2006
A040616 005 Jul 05, 2006
A040616 006 Jul 05, 2006
A040616 007 Jul 05, 2006
A040616 008 Jul 05, 2006
A040301 002 Jul 15, 1999
A040301 003 Jul 15, 1999
A040301 004 Jul 15, 1999
A040301 005 Jul 15, 1999
A040301 006 Jul 15, 1999
A040301 007 Jul 15, 1999
A040301 008 Jul 15, 1999
A040301 009 Jul 15, 1999
A040301 001 Jul 15, 1999
A040663 001 May 30, 2006
A040663 002 May 30, 2006
A040663 003 May 30, 2006
A040663 004 May 30, 2006
A040663 005 May 30, 2006
A040663 006 May 30, 2006
A040663 007 May 30, 2006
A040663 008 May 30, 2006
A040663 009 May 30, 2006
N017284 002
N017284 001
N020547 003 Sep 17, 1999
N020547 001 Sep 26, 1996
A090372 001 Nov 18, 2010
A090372 002 Nov 18, 2010
N020859 001 Aug 13, 1999
N020859 002 Aug 13, 1999
A078829 001 Jun 06, 2008
A078829 002 Jun 06, 2008
A077505 001 Jun 20, 2008
A077505 002 Jun 20, 2008
A077238 001 Jun 06, 2008
A077238 002 Jun 06, 2008
A090374 001 Sep 17, 2009
A090374 002 Sep 17, 2009
A077237 001 Jun 06, 2008
A077237 002 Jun 06, 2008
A077239 001 Jun 06, 2008
A077239 002 Jun 06, 2008
A078989 001 Jun 06, 2008
A078989 002 Jun 06, 2008
A078706 001 Jun 06, 2008
A078706 002 Jun 06, 2008
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-359( of 362)
ZALEPLON
CAPSULE;ORAL
ZALEPLON
AB WEST WARD 5MG A078147 001 Nov 25, 2008
AB 10MG A078147 002 Nov 25, 2008
ZANAMIVIR
POWDER;INHALATION
RELENZA
+ GLAXOSMITHKLINE 5MG N021036 001 Jul 26, 1999
ZICONOTIDE ACETATE
INJECTABLE;INTRATHECAL
PRIALT
+ JAZZ PHARMS INTL 100MCG/1ML (100MCG/ML) N021060 002 Dec 28, 2004
+ 500MCG/20ML (25MCG/ML) N021060 001 Dec 28, 2004
+ 500MCG/5ML (100MCG/ML) N021060 004 Dec 28, 2004
ZIDOVUDINE
CAPSULE;ORAL
RETROVIR
AB + VIIV HLTHCARE 100MG N019655 001 Mar 19, 1987
ZIDOVUDINE
AB AUROBINDO PHARMA LTD 100MG A078128 001 Mar 27, 2006
AB CIPLA LTD 100MG A078349 001 May 23, 2007
INJECTABLE;INJECTION
RETROVIR
AP + VIIV HLTHCARE 10MG/ML N019951 001 Feb 02, 1990
ZIDOVUDINE
AP LIAONING CHENGDA 10MG/ML A204538 001 Nov 26, 2013
AP LUITPOLD 10MG/ML A091457 001 May 06, 2010
SYRUP;ORAL
RETROVIR
AA + VIIV HLTHCARE 50MG/5ML N019910 001 Sep 28, 1989
ZIDOVUDINE
AA AUROBINDO 50MG/5ML A077268 001 Sep 19, 2005
AA CIPLA LTD 50MG/5ML A077981 001 Jun 26, 2008
TABLET;ORAL
ZIDOVUDINE
AB AUROBINDO 300MG A077267 001 Sep 19, 2005
AB CIPLA 300MG A090561 001 Oct 27, 2010
AB + HETERO LABS LTD III 300MG A090092 001 Apr 25, 2008
AB MYLAN PHARMS INC 300MG A078922 001 Feb 14, 2008
AB ROXANE 300MG A076844 001 Sep 19, 2005
AB SUNSHINE LAKE 300MG A202058 001 Oct 07, 2011
ZILEUTON
TABLET;ORAL
ZYFLO
+ CORNERSTONE THERAP 600MG N020471 003 Dec 09, 1996
TABLET, EXTENDED RELEASE;ORAL
ZYFLO CR
+ CORNERSTONE THERAP 600MG N022052 001 May 30, 2007
ZINC ACETATE
CAPSULE;ORAL
GALZIN
TEVA EQ 25MG ZINC N020458 001 Jan 28, 1997
+ EQ 50MG ZINC N020458 002 Jan 28, 1997
ZINC CHLORIDE
INJECTABLE;INJECTION
ZINC CHLORIDE IN PLASTIC CONTAINER
+ HOSPIRA EQ 1MG ZINC/ML N018959 001 Jun 26, 1986
ZIPRASIDONE HYDROCHLORIDE
CAPSULE;ORAL
GEODON
AB + PFIZER EQ 20MG BASE N020825 001 Feb 05, 2001
AB EQ 40MG BASE N020825 002 Feb 05, 2001
AB EQ 60MG BASE N020825 003 Feb 05, 2001
AB EQ 80MG BASE N020825 004 Feb 05, 2001
ZIPRASIDONE HYDROCHLORIDE
AB APOTEX CORP EQ 20MG BASE A077561 001 Mar 02, 2012
AB EQ 40MG BASE A077561 002 Mar 02, 2012
AB EQ 60MG BASE A077561 003 Mar 02, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-360( of 362)
ZIPRASIDONE HYDROCHLORIDE
CAPSULE;ORAL
ZIPRASIDONE HYDROCHLORIDE
AB EQ 80MG BASE A077561 004 Mar 02, 2012
AB DR REDDYS LABS INC EQ 20MG BASE A077565 001 Mar 02, 2012
AB EQ 40MG BASE A077565 002 Mar 02, 2012
AB EQ 60MG BASE A077565 003 Mar 02, 2012
AB EQ 80MG BASE A077565 004 Mar 02, 2012
AB LUPIN PHARMS EQ 20MG BASE A077560 001 Mar 02, 2012
AB EQ 40MG BASE A077560 002 Mar 02, 2012
AB EQ 60MG BASE A077560 003 Mar 02, 2012
AB EQ 80MG BASE A077560 004 Mar 02, 2012
AB MYLAN PHARMS INC EQ 20MG BASE A202395 001 Oct 10, 2013
AB EQ 40MG BASE A202395 002 Oct 10, 2013
AB EQ 60MG BASE A202395 003 Oct 10, 2013
AB EQ 80MG BASE A202395 004 Oct 10, 2013
AB SANDOZ INC EQ 20MG BASE A077562 001 Jun 01, 2012
AB EQ 40MG BASE A077562 002 Jun 01, 2012
AB EQ 60MG BASE A077562 003 Jun 01, 2012
AB EQ 80MG BASE A077562 004 Jun 01, 2012
AB WOCKHARDT LTD EQ 20MG BASE A090348 001 Sep 05, 2012
AB EQ 40MG BASE A090348 002 Sep 05, 2012
AB EQ 60MG BASE A090348 003 Sep 05, 2012
AB EQ 80MG BASE A090348 004 Sep 05, 2012
SUSPENSION;ORAL
GEODON
+ PFIZER INC EQ 10MG BASE/ML N021483 001 Mar 29, 2006
ZIPRASIDONE MESYLATE
INJECTABLE;INTRAMUSCULAR
GEODON
+ PFIZER EQ 20MG BASE/ML N020919 001 Jun 21, 2002
ZOLEDRONIC ACID
INJECTABLE;IV (INFUSION)
RECLAST
AP + NOVARTIS EQ 5MG BASE/100ML N021817 001 Apr 16, 2007
ZOLEDRONIC ACID
AP ACS DOBFAR INFO SA EQ 4MG BASE/100ML N203231 001 Aug 02, 2013
AP EQ 5MG BASE/100ML A202828 001 Sep 23, 2013
AP ACTAVIS INC EQ 4MG BASE/5ML A202472 001 Mar 04, 2013
AP AGILA SPECLTS EQ 4MG BASE/5ML A202650 001 Mar 04, 2013
AP DR REDDYS LABS LTD EQ 4MG BASE/5ML A091186 001 Mar 04, 2013
AP EQ 5MG BASE/100ML A091363 001 Mar 29, 2013
AP EMCURE PHARMS LTD EQ 4MG BASE/5ML A201783 001 Mar 12, 2013
AP EQ 5MG BASE/100ML A201801 001 Mar 29, 2013
AP GLAND PHARMA LTD EQ 4MG BASE/5ML A202930 001 Aug 05, 2013
AP HIKMA FARMACEUTICA EQ 4MG BASE/5ML A202182 001 Jun 03, 2013
AP HOSPIRA INC EQ 5MG BASE/100ML A202837 001 Apr 05, 2013
AP PHARMACEUTICS EQ 4MG BASE/5ML A091170 001 Mar 04, 2013
AP EQ 5MG BASE/100ML A202163 001 Aug 05, 2013
AP PHARMS EQ 4MG BASE/5ML A202571 001 May 07, 2013
AP SUN PHARMA GLOBAL EQ 4MG BASE/5ML A202746 001 Mar 04, 2013
ZOMETA
AP + NOVARTIS EQ 4MG BASE/5ML N021223 002 Mar 07, 2003
AP + EQ 4MG BASE/100ML N021223 003 Jun 17, 2011
ZOLEDRONIC ACID
+ SUN PHARMA GLOBAL EQ 4MG BASE/VIAL A090018 001 Mar 04, 2013
ZOLMITRIPTAN
SPRAY;NASAL
ZOMIG
ASTRAZENECA 2.5MG/SPRAY N021450 003 Sep 16, 2013
+ 5MG/SPRAY N021450 004 Sep 30, 2003
TABLET;ORAL
ZOLMITRIPTAN
AB APOTEX INC 2.5MG A202078 001 May 14, 2013
AB 5MG A202078 002 May 14, 2013
AB GLENMARK GENERICS 2.5MG A201779 001 May 14, 2013
AB 5MG A201779 002 May 14, 2013
AB MYLAN PHARMS INC 2.5MG A203186 001 May 14, 2013
AB 5MG A203186 002 May 14, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
ZOLMITRIPTAN
TABLET;ORAL
ZOMIG
AB IPR 2.5MG
AB + 5MG
TABLET, ORALLY DISINTEGRATING;ORAL
ZOLMITRIPTAN
AB APOTEX INC
AB
AB GLENMARK GENERICS
AB
AB ZYDUS PHARMS USA INC
AB
ZOMIG-ZMT
AB ASTRAZENECA
AB +
ZOLPIDEM TARTRATE
SPRAY, METERED;ORAL
ZOLPIMIST
+ NOVADEL
TABLET;ORAL
AMBIEN
AB SANOFI AVENTIS US
AB +
ZOLPIDEM TARTRATE
AB APOTEX INC
AB
AB AUROBINDO PHARMA
AB
AB CARACO
AB
AB CARLSBAD
AB
AB CIPLA LTD
AB
AB HIKMA
AB
AB INVAGEN PHARMS
AB
AB LEK PHARMS DD
AB
AB MYLAN
AB
AB RANBAXY
AB
AB ROXANE
AB
AB TEVA
AB
AB TORRENT PHARMS
AB
AB VINTAGE
AB
AB WATSON LABS
AB
AB WOCKHARDT
AB
TABLET;SUBLINGUAL
EDLUAR
MEDA PHARMS
+
INTERMEZZO
PURDUE PHARMA
+
TABLET, EXTENDED RELEASE;ORAL
AMBIEN CR
AB SANOFI AVENTIS US
AB +
ZOLPIDEM TARTRATE
AB ACTAVIS ELIZABETH
AB
AB ANCHEN PHARMS
2.5MG
5MG
2.5MG
5MG
2.5MG
5MG
2.5MG
5MG
5MG/SPRAY
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
1.75MG
3.5MG
6.25MG
12.5MG
6.25MG
12.5MG
6.25MG
3-361( of 362)
N020768 001 Nov 25, 1997
N020768 002 Nov 25, 1997
A202476 001 May 14, 2013
A202476 002 May 14, 2013
A202560 001 May 14, 2013
A202560 002 May 14, 2013
A202890 001 May 15, 2013
A202890 002 May 15, 2013
N021231 001 Feb 13, 2001
N021231 002 Sep 17, 2001
N022196 001 Dec 19, 2008
N019908 001 Dec 16, 1992
N019908 002 Dec 16, 1992
A077884 001 Apr 23, 2007
A077884 002 Apr 23, 2007
A078413 001 May 04, 2007
A078413 002 May 04, 2007
A077359 001 Apr 23, 2007
A077359 002 Apr 23, 2007
A077990 001 Apr 23, 2007
A077990 002 Apr 23, 2007
A077388 001 Jul 30, 2012
A077388 002 Jul 30, 2012
A078129 001 Apr 30, 2008
A078129 002 Apr 30, 2008
A078184 001 Sep 07, 2007
A078184 002 Sep 07, 2007
A077322 001 Apr 23, 2007
A077322 002 Apr 23, 2007
A076578 001 Apr 23, 2007
A076578 002 Apr 23, 2007
A078055 001 Apr 23, 2007
A078055 002 Apr 23, 2007
A077214 001 Apr 23, 2007
A077214 002 Apr 23, 2007
A076410 001 Apr 23, 2007
A076410 002 Apr 23, 2007
A077903 001 Aug 17, 2007
A077903 002 Aug 17, 2007
A078616 001 Nov 21, 2008
A078616 002 Nov 21, 2008
A077773 001 Apr 23, 2007
A077773 002 Apr 23, 2007
A078426 001 May 15, 2007
A078426 002 May 15, 2007
N021997 001 Mar 13, 2009
N021997 002 Mar 13, 2009
N022328 001 Nov 23, 2011
N022328 002 Nov 23, 2011
N021774 002 Sep 02, 2005
N021774 001 Sep 02, 2005
A078179 002 Oct 13, 2010
A078179 001 Jun 06, 2011
A078148 002 Apr 14, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-362( of 362)
ZOLPIDEM TARTRATE
TABLET, EXTENDED RELEASE;ORAL
ZOLPIDEM TARTRATE
AB 12.5MG A078148 001 Dec 03, 2010
AB APOTEX INC 6.25MG A200266 001 Sep 10, 2013
AB 12.5MG A200266 002 Sep 10, 2013
AB LUPIN LTD 6.25MG A078970 001 Sep 11, 2013
AB 12.5MG A078970 002 Sep 11, 2013
AB SANDOZ 6.25MG A090107 001 Jul 01, 2011
AB 12.5MG A090107 002 Jul 01, 2011
AB SYNTHON PHARMS 6.25MG A078483 001 Apr 12, 2011
AB 12.5MG A078483 002 Jun 06, 2011
AB WATSON LABS INC FL 6.25MG A090153 001 Mar 25, 2013
AB 12.5MG A090153 002 Mar 25, 2013
ZONISAMIDE
CAPSULE;ORAL
ZONEGRAN
AB EISAI INC 25MG N020789 003 Aug 22, 2003
AB 50MG N020789 002 Aug 22, 2003
AB + 100MG N020789 001 Mar 27, 2000
ZONISAMIDE
AB APOTEX INC 25MG A077642 001 Dec 22, 2005
AB 50MG A077642 002 Dec 22, 2005
AB 100MG A077642 003 Dec 22, 2005
AB BANNER PHARMACAPS 25MG A077813 001 Aug 16, 2006
AB 50MG A077813 002 Aug 16, 2006
AB 100MG A077813 003 Aug 16, 2006
AB BARR 25MG A077639 001 Dec 22, 2005
AB 50MG A077639 002 Dec 22, 2005
AB 100MG A077639 003 Dec 22, 2005
AB GLENMARK GENERICS 25MG A077651 001 Jan 30, 2006
AB 50MG A077651 002 Jan 30, 2006
AB 100MG A077651 003 Jan 30, 2006
AB INVAGEN PHARMS 25MG A077869 001 May 31, 2006
AB 50MG A077869 002 May 31, 2006
AB 100MG A077869 003 May 31, 2006
AB MYLAN 25MG A077637 001 Dec 22, 2005
AB 50MG A077637 002 Dec 22, 2005
AB 100MG A077637 003 Dec 22, 2005
AB MYLAN PHARMS INC 25MG A077647 001 Dec 22, 2005
AB 50MG A077647 002 Dec 22, 2005
AB 100MG A077647 003 Dec 22, 2005
AB SANDOZ 25MG A077644 001 Dec 22, 2005
AB 50MG A077644 002 Dec 22, 2005
AB 100MG A077644 003 Dec 22, 2005
AB SUN PHARM INDS (IN) 25MG A077634 001 Mar 17, 2006
AB 50MG A077634 002 Mar 17, 2006
AB 100MG A077634 003 Mar 17, 2006
AB WOCKHARDT 25MG A077636 003 Jul 27, 2006
AB 50MG A077636 002 Jul 27, 2006
AB 100MG A077636 001 Dec 22, 2005
AB ZYDUS PHARMS USA 25MG A077625 001 Oct 16, 2006
AB 50MG A077625 002 Oct 16, 2006
AB 100MG A077625 003 Oct 16, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ACETAMINOPHEN
SUPPOSITORY;RECTAL
ACEPHEN
G AND W LABS
ACETAMINOPHEN
PERRIGO NEW YORK
TARO PHARMS NORTH
+
INFANTS' FEVERALL
TARO PHARMS NORTH
NEOPAP
POLYMEDICA
TABLET, EXTENDED RELEASE;ORAL
ACETAMINOPHEN
OHM LABS
PERRIGO
RANBAXY LABS LTD
TYLENOL
+ MCNEIL CONS
+
OTC DRUG PRODUCT LIST
120MG
325MG
325MG
650MG
650MG
120MG
650MG
120MG
325MG
650MG
80MG
120MG
650MG
650MG
650MG
650MG
650MG
ACETAMINOPHEN; ASPIRIN; CAFFEINE
TABLET;ORAL
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
PERRIGO 250MG;250MG;65MG
EXCEDRIN (MIGRAINE)
+ NOVARTIS 250MG;250MG;65MG
ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET;ORAL
TAVIST ALLERGY/SINUS/HEADACHE
+ NOVARTIS 500MG;EQ 0.25MG BASE;30MG
ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
DRIXORAL PLUS
+ SCHERING PLOUGH 500MG;3MG;60MG
ALCOHOL; CHLORHEXIDINE GLUCONATE
SOLUTION;TOPICAL
AVAGARD
+ 3M 61%;1%
ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE
TABLET, CHEWABLE;ORAL
FOAMCOAT
GUARDIAN DRUG 80MG;20MG
GAVISCON
SANOFI AVENTIS US 80MG;20MG
+ 160MG;40MG
ASPIRIN
CAPSULE;ORAL
ASPIRIN
+ PLX PHARMA 325MG
AVOBENZONE; ECAMSULE; OCTOCRYLENE
CREAM;TOPICAL
ANTHELIOS SX
+ LOREAL USA 2%;2%;10%
CAPITAL SOLEIL 15
+ LOREAL USA 2%;3%;10%
AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE
CREAM;TOPICAL
ANTHELIOS 20
+ LOREAL USA 2%;2%;10%;2%
ANTHELIOS 40
+ LOREAL USA 2%;3%;10%;5%
+ 2%;3%;10%;5%
4-1( of 17)
N018060 001
A072344 001 Mar 27, 1992
N018060 003 Dec 18, 1986
A072237 001 Mar 27, 1992
N018060 002
A070607 001 Apr 06, 1987
A070608 001 Dec 01, 1986
N018337 003 Sep 12, 1983
N018337 002
N018337 001
N018337 004 Aug 26, 1992
N016401 001
A076200 001 Mar 19, 2002
A075077 001 Feb 25, 2000
A078569 001 Dec 14, 2011
N019872 001 Jun 08, 1994
N019872 002 Jan 11, 2001
A075794 001 Nov 26, 2001
N020802 001 Jan 14, 1998
N021082 001 Mar 01, 2001
N019453 001 May 22, 1987
N021074 001 Jun 07, 2001
A071793 001 Sep 04, 1987
N018685 001 Dec 09, 1983
N018685 002 Dec 09, 1983
N203697 001 Jan 14, 2013
N021502 001 Jul 21, 2006
N021501 001 Oct 02, 2006
N021471 001 Oct 05, 2006
N022009 001 Mar 31, 2008
N022009 002 Oct 29, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-2( of 17)
AVOBENZONE; OCTINOXATE; OXYBENZONE
LOTION;TOPICAL
SHADE UVAGUARD
+ SCHERING PLOUGH 3%;7.5%;3% N020045 001 Dec 07, 1992
BENTOQUATAM
LOTION;TOPICAL
IVY BLOCK
+ STAND HOMEOPATH 5% N020532 001 Aug 26, 1996
BUTENAFINE HYDROCHLORIDE
CREAM;TOPICAL
LOTRIMIN ULTRA
+ SCHERING PLOUGH 1% N021307 001 Dec 07, 2001
BUTOCONAZOLE NITRATE
CREAM;VAGINAL
FEMSTAT 3
+ BAYER 2% N020421 001 Dec 21, 1995
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
TABLET, CHEWABLE;ORAL
CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE
PERRIGO R AND D 800MG;10MG;165MG A077355 001 Feb 06, 2008
PEPCID COMPLETE
+ MCNEIL CONS 800MG;10MG;165MG N020958 001 Oct 16, 2000
CETIRIZINE HYDROCHLORIDE
CAPSULE;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
BANNER PHARMACAPS 5MG N022429 001 Jul 23, 2009
+ 10MG N022429 004 Jul 23, 2009
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
BANNER PHARMACAPS 5MG N022429 003 Jul 23, 2009
+ 10MG N022429 002 Jul 23, 2009
SYRUP;ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
AMNEAL PHARMS 5MG/5ML A090765 002 Oct 07, 2009
AUROBINDO PHARMA 5MG/5ML A090750 002 Feb 02, 2010
BIO PHARM INC 5MG/5ML A090474 002 Mar 30, 2009
CARACO 5MG/5ML A091327 001 Oct 17, 2011
CYPRESS PHARM 5MG/5ML A090300 001 Oct 10, 2008
PERRIGO R AND D 5MG/5ML A204226 001 Sep 09, 2013
5MG/5ML A090254 002 Apr 09, 2008
SILARX 5MG/5ML A091130 001 Apr 22, 2011
TARO 5MG/5ML A090182 002 Apr 22, 2008
5MG/5ML A201546 001 May 20, 2011
TRIS PHARMA INC 5MG/5ML A090572 001 Nov 16, 2012
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
AMNEAL PHARMS 5MG/5ML A090765 001 Oct 07, 2009
AUROBINDO PHARMA 5MG/5ML A090750 001 Feb 02, 2010
BIO PHARM INC 5MG/5ML A090474 001 Mar 30, 2009
CARACO 5MG/5ML A091327 002 Oct 17, 2011
CYPRESS PHARM 5MG/5ML A090300 002 Oct 10, 2008
PERRIGO R AND D 5MG/5ML A090254 001 Apr 09, 2008
SILARX 5MG/5ML A091130 002 Apr 22, 2011
TARO 5MG/5ML A090182 001 Apr 22, 2008
5MG/5ML A201546 002 May 20, 2011
TRIS PHARMA INC 5MG/5ML A090572 002 Nov 16, 2012
CHILDREN'S ZYRTEC ALLERGY
+ MCNEIL CONSUMER 5MG/5ML N022155 002 Nov 16, 2007
CHILDREN'S ZYRTEC HIVES RELIEF
+ MCNEIL CONSUMER 5MG/5ML N022155 001 Nov 16, 2007
TABLET;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
AMNEAL PHARMS NY 5MG A078780 001 Jan 21, 2010
10MG A078780 004 Jan 21, 2010
APOTEX INC 5MG A078317 001 Dec 27, 2007
10MG A078317 002 Dec 27, 2007
CADISTA PHARMS 5MG A078933 001 Jun 15, 2010
10MG A078933 002 Jun 15, 2010
CARACO 5MG A077499 001 Dec 27, 2007
10MG A077499 002 Dec 27, 2007
CIPLA LTD 5MG A077318 001 Jul 25, 2013
10MG A077318 002 Jul 25, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
CETIRIZINE HYDROCHLORIDE
TABLET;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
CONTRACT PHARMACAL
DR REDDYS LABS LTD
MYLAN
ORCHID HLTHCARE
PERRIGO R AND D
RANBAXY
SANDOZ
TARO
TORRENT PHARMS LLC
UNICHEM
UNIQUE PHARM LABS
WOCKHARDT
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
5MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
CETIRIZINE HYDROCHLORIDE HIVES
CADISTA PHARMS
CARACO
DR REDDYS LABS LTD
MYLAN
ORCHID HLTHCARE
PERRIGO R AND D
RANBAXY
UNICHEM
UNIQUE PHARM LABS
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
AMNEAL PHARMS NY 5MG
10MG
TARO 10MG
10MG
TORRENT PHARMS LLC 5MG
10MG
ZYRTEC ALLERGY
MCNEIL CONSUMER 5MG
+ 10MG
ZYRTEC HIVES RELIEF
MCNEIL CONSUMER 5MG
+ 10MG
TABLET, CHEWABLE;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
CARACO 5MG
10MG
SANDOZ 5MG
+ 10MG
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
CARACO 5MG
10MG
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
SUN PHARMA GLOBAL 5MG
10MG
4-3( of 17)
A076047 001 Dec 27, 2007
A076047 002 Dec 27, 2007
A078343 004 Jan 15, 2008
A078343 003 Jan 15, 2008
A076677 001 Dec 27, 2007
A076677 002 Dec 27, 2007
A078862 001 Feb 19, 2009
A078862 002 Feb 19, 2009
A078336 001 Dec 27, 2007
A078336 002 Dec 27, 2007
A077498 001 Dec 27, 2007
A077498 002 Dec 27, 2007
A077946 001 Dec 27, 2007
A077946 002 Dec 27, 2007
A078072 001 Jul 22, 2009
A078072 003 Jul 22, 2009
A079191 001 Apr 15, 2010
A079191 004 Apr 15, 2010
A078680 003 Jun 26, 2009
A078680 004 Jun 26, 2009
A077829 001 Aug 26, 2009
A077829 004 Aug 26, 2009
A078427 003 Dec 28, 2007
A078427 004 Dec 28, 2007
A078933 003 Jun 15, 2010
A078933 004 Jun 15, 2010
A077499 003 Dec 27, 2007
A077499 004 Dec 27, 2007
A078343 001 Jan 15, 2008
A078343 002 Jan 15, 2008
A076677 004 Dec 27, 2007
A076677 003 Dec 27, 2007
A078862 003 Feb 19, 2009
A078862 004 Feb 19, 2009
A078336 003 Dec 27, 2007
A078336 004 Dec 27, 2007
A077498 003 Dec 27, 2007
A077498 004 Dec 27, 2007
A078680 001 Jun 26, 2009
A078680 002 Jun 26, 2009
A077829 003 Aug 26, 2009
A077829 002 Aug 26, 2009
A078780 003 Jan 21, 2010
A078780 002 Jan 21, 2010
A078072 002 Jul 22, 2009
A078072 004 Jul 22, 2009
A079191 003 Apr 15, 2010
A079191 002 Apr 15, 2010
N019835 003 Nov 16, 2007
N019835 004 Nov 16, 2007
N019835 005 Nov 16, 2007
N019835 006 Nov 16, 2007
A077631 004 Jan 11, 2008
A077631 003 Jan 11, 2008
A078692 001 Feb 14, 2008
A078692 002 Feb 14, 2008
A077631 001 Jan 11, 2008
A077631 002 Jan 11, 2008
A090142 001 Aug 30, 2011
A090142 002 Aug 30, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
CETIRIZINE HYDROCHLORIDE
TABLET, CHEWABLE;ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
SUN PHARMA GLOBAL 5MG
10MG
TABLET, ORALLY DISINTEGRATING;ORAL
ZYRTEC ALLERGY
+ MCNEIL CONSUMER 10MG
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS
SANDOZ
SUN PHARM INDS LTD
ZYRTEC-D 12 HOUR
+ MCNEIL
CHLORHEXIDINE GLUCONATE
AEROSOL, METERED;TOPICAL
EXIDINE
+ XTTRIUM
CLOTH;TOPICAL
CHLORHEXIDINE GLUCONATE
+ SAGE PRODS
SOLUTION;TOPICAL
BRIAN CARE
SOAPCO
CHG SCRUB
ECOLAB
CIDA-STAT
ECOLAB
DYNA-HEX
BAJAJ MEDICAL LLC
EXIDINE
+ XTTRIUM
HIBICLENS
+ MOLNLYCKE HLTH
HIBISTAT
+ MOLNLYCKE HLTH
SPONGE;TOPICAL
BIOSCRUB
GRIFFEN
CHLORHEXIDINE GLUCONATE
BECTON DICKINSON
PHARMASEAL SCRUB CARE
+ CAREFUSION
5MG;120MG
5MG;120MG
5MG;120MG
5MG;120MG
4%
2%
4%
4%
2%
0.75%
2%
4%
4%
0.5%
4%
4%
4%
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
SPONGE;TOPICAL
CHLORAPREP ONE-STEP
+ CAREFUSION
+
+
CHLORAPREP ONE-STEP FREPP
+ CAREFUSION
CHLORAPREP WITH TINT
+ CAREFUSION
+
+
SWAB;TOPICAL
CHLORAPREP ONE-STEP SEPP
+ CAREFUSION
CHLORAPREP SINGLE SWABSTICK
+ CAREFUSION
CHLORAPREP TRIPLE SWABSTICK
+ CAREFUSION
PREVANTICS MAXI SWABSTICK
+ PROF DSPLS
PREVANTICS SWAB
+ PROF DSPLS
2%;70% (3ML)
2%;70% (10.5ML)
2%;70% (26ML)
2%;70% (1.5ML)
2%;70% (26ML)
2%;70% (10.5ML)
2%;70% (3ML)
2%;70% (0.67ML)
2%;70% (1.75ML)
2%;70% (5.25ML)
3.15%;70% (5.1ML)
3.15%;70% (1ML)
4-4( of 17)
A090142 003 Aug 30, 2011
A090142 004 Aug 30, 2011
N022578 001 Sep 03, 2010
A077170 001 Feb 25, 2008
A077991 001 Mar 05, 2008
A090922 001 Sep 28, 2012
N021150 002 Nov 09, 2007
N019127 001 Dec 24, 1984
N021669 001 Apr 25, 2005
A071419 001 Dec 17, 1987
N019258 002 Jul 22, 1986
N019258 001 Jul 22, 1986
N020111 001 Sep 11, 1997
N019422 001 Dec 17, 1985
N019125 001 Dec 24, 1984
N017768 001
N018300 001
N019822 001 Mar 31, 1989
A072525 001 Oct 24, 1989
N019793 001 Dec 02, 1988
N020832 001 Jul 14, 2000
N020832 004 Aug 20, 2003
N020832 006 Nov 21, 2006
N020832 003 Apr 26, 2002
N020832 002 May 03, 2005
N020832 005 Apr 03, 2006
N020832 007 Oct 10, 2006
N021555 001 Oct 07, 2002
N021555 002 May 10, 2005
N021555 003 Jun 10, 2009
N021524 003 Jun 03, 2005
N021524 001 Jun 03, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
SWAB;TOPICAL
PREVANTICS SWABSTICK
+ PROF DSPLS
CHLORPHENIRAMINE MALEATE
TABLET, EXTENDED RELEASE;ORAL
CHLOR-TRIMETON
+ SCHERING PLOUGH
CHLORPHENIRAMINE MALEATE
AVANTHI INC
3.15%;70% (1.6ML)
12MG
12MG
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
TABLET;ORAL
ADVIL ALLERGY AND CONGESTION RELIEF
+ PFIZER 4MG;200MG;10MG
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
SUSPENSION;ORAL
CHILDREN'S ADVIL ALLERGY SINUS
+ PFIZER 1MG/5ML;100MG/5ML;15MG/5ML
TABLET;ORAL
ADVIL ALLERGY SINUS
+ PFIZER 2MG;200MG;30MG
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
CHLOR-TRIMETON
+ SCHERING PLOUGH
CIMETIDINE
TABLET;ORAL
CIMETIDINE
APOTEX
CONTRACT PHARMACAL
IVAX SUB TEVA PHARMS
PERRIGO
WATSON LABS
TAGAMET HB
+ MEDTECH PRODS
CLEMASTINE FUMARATE
TABLET;ORAL
CLEMASTINE FUMARATE
PERRIGO
SANDOZ
TAVIST-1
+ NOVARTIS
CLOTRIMAZOLE
CREAM;VAGINAL
CLOTRIMAZOLE
ACTAVIS MID ATLANTIC
TARO
GYNE-LOTRIMIN
+ SCHERING PLOUGH
GYNE-LOTRIMIN 3
+ SCHERING PLOUGH
MYCELEX-7
BAYER
TRIVAGIZOLE 3
TARO
8MG;120MG
100MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
1.34MG
1.34MG
1.34MG
1%
1%
1%
2%
1%
2%
CREAM, TABLET;TOPICAL, VAGINAL
GYNE-LOTRIMIN 3 COMBINATION PACK
+ SCHERING PLOUGH 200MG;200MG
GYNE-LOTRIMIN COMBINATION PACK
+ SCHERING PLOUGH
MYCELEX-7 COMBINATION PACK
BAYER
TABLET;VAGINAL
GYNE-LOTRIMIN
+ SCHERING PLOUGH
100MG;100MG
1%;100MG
100MG
4-5( of 17)
N021524 002 Jun 03, 2005
N007638 002
A040829 001 May 13, 2009
N022113 001 Dec 21, 2011
N021587 001 Feb 24, 2004
N021441 001 Dec 19, 2002
N018397 001
A074948 001 Jun 19, 1998
A074948 002 Jul 26, 2002
A074961 001 Jun 19, 1998
A074963 001 Jun 19, 1998
A075345 001 Jun 16, 1999
A075285 001 Oct 29, 1998
A075425 001 Jul 29, 1999
N020238 002 Aug 21, 1996
A074512 001 Nov 22, 1995
A073458 001 Oct 31, 1993
N020925 001 Aug 21, 1992
A074165 001 Jul 16, 1993
A072641 001 Dec 04, 1995
N018052 002 Nov 30, 1990
N020574 001 Nov 24, 1998
N018230 002 Dec 26, 1991
N021143 001 Apr 12, 2000
N020526 002 Jul 29, 1996
N020289 002 Apr 26, 1993
N020389 002 Jun 23, 1994
N017717 002 Nov 30, 1990
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-6( of 17)
CLOTRIMAZOLE
TABLET;VAGINAL
GYNE-LOTRIMIN 3
SCHERING PLOUGH +
MYCELEX-7
200MG N020525 001 Jul 29, 1996
BAYER 100MG N018182 002 Dec 26, 1991
CROMOLYN SODIUM
SPRAY, METERED;NASAL
CROMOLYN SODIUM
+ BAUSCH AND LOMB
PERRIGO
5.2MG/SPRAY
5.2MG/SPRAY
A075702 001
A075427 001
Jul 03, 2001
Dec 12, 2001
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE
+ AVANTHI INC 6MG;120MG A078648 001 Feb 27, 2013
DISOPHROL
SCHERING PLOUGH 6MG;120MG N013483 004 Sep 13, 1982
DRIXORAL
SCHERING PLOUGH 6MG;120MG N013483 003 Sep 13, 1982
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
TABLET, EXTENDED RELEASE;ORAL
MUCINEX DM
RECKITT BENCKISER 30MG;600MG N021620 002 Apr 29, 2004
+ 60MG;1.2GM N021620 001 Apr 29, 2004
DEXTROMETHORPHAN POLISTIREX
SUSPENSION, EXTENDED RELEASE;ORAL
DELSYM
+ RECKITT BENCKISER EQ 30MG HBR/5ML N018658 001 Oct 08, 1982
DEXTROMETHORPHAN POLISTIREX
TRIS PHARMA INC EQ 30MG HBR/5ML A091135 001 May 25, 2012
DIPHENHYDRAMINE CITRATE; IBUPROFEN
TABLET;ORAL
ADVIL PM
+ PFIZER 38MG;200MG N021394 001 Dec 21, 2005
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
DR REDDYS LABS LTD 38MG;200MG A090619 001 Jul 08, 2009
PERRIGO R AND D 38MG;200MG A079113 001 Dec 22, 2008
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
CAPSULE;ORAL
ADVIL PM
+ PFIZER 25MG;EQ 200MG FREE ACID AND POTASSIUM N021393 001 Dec 21, 2005
SALT
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
BANNER PHARMACAPS 25MG;EQ 200MG FREE ACID AND POTASSIUM A090397 001 Nov 22, 2010
SALT
STRIDES ARCOLAB LTD 25MG;EQ 200MG FREE ACID AND POTASSIUM A200888 001 Mar 05, 2012
SALT
DOCOSANOL
CREAM;TOPICAL
ABREVA
+ GLAXOSMITHKLINE 10% N020941 001 Jul 25, 2000
DOXYLAMINE SUCCINATE
TABLET;ORAL
DOXYLAMINE SUCCINATE
LNK 25MG A040564 001 Aug 27, 2004
PERRIGO 25MG A040167 001 Sep 18, 1996
UNISOM
+ CHATTEM 25MG N018066 001
FAMOTIDINE
TABLET;ORAL
FAMOTIDINE
DR REDDYS LABS LTD 10MG A075758 001 Aug 17, 2001
20MG A077367 001 Sep 25, 2006
IVAX SUB TEVA PHARMS 10MG A075512 001 Jul 26, 2001
MYLAN 10MG A075674 001 Dec 21, 2001
PERRIGO 10MG A075400 001 Mar 18, 2005
20MG A077351 001 Sep 25, 2006
RANBAXY 10MG A090283 001 Nov 17, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
FAMOTIDINE
TABLET;ORAL
FAMOTIDINE
TEVA
WATSON LABS
WOCKHARDT
PEPCID AC
MCNEIL CONS
+
PEPCID AC
MCNEIL CONS
TABLET, CHEWABLE;ORAL
FAMOTIDINE
PERRIGO
PEPCID AC
+ MCNEIL CONS
FEXOFENADINE HYDROCHLORIDE
SUSPENSION;ORAL
CHILDREN'S ALLEGRA ALLERGY
+ SANOFI AVENTIS US
CHILDREN'S ALLEGRA HIVES
+ SANOFI AVENTIS US
TABLET;ORAL
ALLEGRA ALLERGY
SANOFI AVENTIS US
+
ALLEGRA HIVES
SANOFI AVENTIS US
+
CHILDREN'S ALLEGRA ALLERGY
SANOFI AVENTIS US
CHILDREN'S ALLEGRA HIVES
SANOFI AVENTIS US
OTC DRUG PRODUCT LIST
20MG
10MG
10MG
10MG
20MG
10MG
20MG
10MG
10MG
20MG
30MG/5ML
30MG/5ML
60MG
180MG
60MG
180MG
30MG
30MG
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
DR REDDYS LABS LTD 30MG
MYLAN 30MG
SUN PHARM INDS 30MG
TEVA 30MG
WOCKHARDT LTD 30MG
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
DR REDDYS LABS LTD 30MG
MYLAN 30MG
SUN PHARM INDS 30MG
TEVA 30MG
WOCKHARDT LTD 30MG
FEXOFENADINE HYDROCHLORIDE ALLERGY
DR REDDYS LABS LTD 60MG
MYLAN
180MG
60MG
SUN PHARM INDS
180MG
60MG
180MG
TEVA
WOCKHARDT LTD
60MG
180MG
60MG
180MG
FEXOFENADINE HYDROCHLORIDE HIVES
DR REDDYS LABS LTD 60MG
MYLAN
180MG
60MG
180MG
SUN PHARM INDS
TEVA
60MG
180MG
60MG
WOCKHARDT LTD
180MG
60MG
180MG
4-7( of 17)
A090283 002 Nov 17, 2009
A075312 001 May 31, 2001
A075404 001 Nov 28, 2001
A077146 001 Mar 07, 2005
A090837 001 Aug 04, 2010
N020325 001 Apr 28, 1995
N020325 002 Sep 23, 2003
N020902 001 Aug 05, 1999
A075715 001 Aug 22, 2003
N020801 002 Dec 17, 2007
N201373 001 Jan 24, 2011
N201373 002 Jan 24, 2011
N020872 007 Jan 24, 2011
N020872 010 Jan 24, 2011
N020872 008 Jan 24, 2011
N020872 009 Jan 24, 2011
N020872 005 Jan 24, 2011
N020872 006 Jan 24, 2011
A076502 004 Apr 12, 2011
A077081 004 Jul 21, 2011
A091567 002 Feb 06, 2012
A076447 004 Apr 13, 2011
A079112 002 Feb 08, 2012
A076502 005 Apr 12, 2011
A077081 005 Jul 21, 2011
A091567 001 Feb 06, 2012
A076447 005 Apr 13, 2011
A079112 001 Feb 08, 2012
A076502 006 Apr 12, 2011
A076502 008 Apr 12, 2011
A077081 006 Jul 21, 2011
A077081 008 Jul 21, 2011
A091567 004 Feb 06, 2012
A091567 006 Feb 06, 2012
A076447 006 Apr 13, 2011
A076447 008 Apr 13, 2011
A079112 004 Feb 08, 2012
A079112 006 Feb 08, 2012
A076502 007 Apr 12, 2011
A076502 009 Apr 12, 2011
A077081 007 Jul 21, 2011
A077081 009 Jul 21, 2011
A091567 003 Feb 06, 2012
A091567 005 Feb 06, 2012
A076447 007 Apr 13, 2011
A076447 009 Apr 13, 2011
A079112 003 Feb 08, 2012
A079112 005 Feb 08, 2012
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
FEXOFENADINE HYDROCHLORIDE
TABLET, ORALLY DISINTEGRATING;ORAL
CHILDREN'S ALLEGRA ALLERGY
+ SANOFI AVENTIS US 30MG
CHILDREN'S ALLEGRA HIVES
+ SANOFI AVENTIS US 30MG
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
DR REDDYS LABS LTD 30MG
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
DR REDDYS LABS LTD 30MG
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
+ SANOFI AVENTIS US 60MG;120MG
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
+ SANOFI AVENTIS US 180MG;240MG
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
DR REDDYS LABS LTD
GUAIFENESIN
TABLET, EXTENDED RELEASE;ORAL
GUAIFENESIN
PERRIGO R AND D
MUCINEX
+ RECKITT BENCKISER
180MG;240MG
600MG
1.2GM
600MG
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
MUCINEX D
+ RECKITT BENCKISER
IBUPROFEN
CAPSULE;ORAL
ADVIL LIQUI-GELS
+ PFIZER
ADVIL MIGRAINE LIQUI-GELS
+ PFIZER
IBUPROFEN
AMNEAL PHARMS
BANNER PHARMACAPS
+ CONTRACT PHARMACAL
MARKSANS PHARMA
PLD ACQUISITIONS
MIDOL LIQUID GELS
+ BANNER PHARMACAPS
SUSPENSION;ORAL
CHILDREN'S ADVIL
PFIZER
CHILDREN'S ADVIL-FLAVORED
PFIZER
CHILDREN'S ELIXSURE
ALTERNA TCHP LLC
CHILDREN'S IBUPROFEN
PERRIGO
CHILDREN'S MOTRIN
+ MCNEIL
IBUPROFEN
ACTAVIS MID ATLANTIC
AMNEAL PHARMS
SUSPENSION/DROPS;ORAL
CHILDREN'S MOTRIN
+ MCNEIL CONS
IBUPROFEN
PERRIGO
TRIS PHARMA INC
PEDIATRIC ADVIL
+ PFIZER
TABLET;ORAL
ADVIL
PFIZER
1.2GM;120MG
600MG;60MG
EQ 200MG FREE ACID AND POTASSIUM SALT
EQ 200MG FREE ACID AND POTASSIUM SALT
EQ 200MG FREE ACID AND POTASSIUM SALT
EQ 200MG FREE ACID AND POTASSIUM SALT
200MG
EQ 200MG FREE ACID AND POTASSIUM SALT
EQ 200MG FREE ACID AND POTASSIUM SALT
200MG
100MG/5ML
100MG/5ML
100MG/5ML
100MG/5ML
100MG/5ML
100MG/5ML
100MG/5ML
40MG/ML
40MG/ML
40MG/ML
100MG/2.5ML
200MG
4-8( of 17)
N021909 002 Jan 24, 2011
N021909 003 Jan 24, 2011
A202978 001 Jan 18, 2013
A202978 002 Jan 18, 2013
N020786 002 Jan 24, 2011
N021704 002 Jan 24, 2011
A079043 002 Jun 22, 2011
A078912 001 Nov 23, 2011
N021282 002 Dec 18, 2002
N021282 001 Jul 12, 2002
N021585 002 Jun 22, 2004
N021585 001 Jun 22, 2004
N020402 001 Apr 20, 1995
N020402 002 Mar 16, 2000
A202300 001 Dec 23, 2011
A078682 001 Mar 24, 2009
A074782 001 Jul 06, 1998
A079205 001 Jun 26, 2009
A077338 001 Jul 10, 2009
N021472 001 Oct 18, 2002
N020589 001 Jun 27, 1996
N020589 002 Nov 07, 1997
N021604 001 Jan 07, 2004
A074937 001 Dec 22, 1998
N020516 001 Jun 16, 1995
A074916 001 Apr 30, 1999
A200457 001 Aug 18, 2011
N020603 001 Jun 10, 1996
A075217 001 Dec 16, 1998
A079058 001 Aug 31, 2009
N020812 001 Jan 30, 1998
N018989 001 May 18, 1984
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
4-9( of 17)
A071057 001 Aug 11, 1988
A071333 001 Feb 17, 1987
A072199 001 May 23, 1988
A076460 001 Nov 26, 2003
A071732 001 Sep 10, 1987
A071735 001 Sep 10, 1987
A072299 001 Jul 01, 1988
A074931 001 Jul 20, 1998
A075661 001 Dec 12, 2001
A076117 001 Nov 20, 2001
A079174 001 Dec 10, 2010
A076741 001 Jun 17, 2004
A075010 001 Mar 01, 1999
A075139 001 Mar 01, 1999
A091237 001 Feb 08, 2011
A091239 001 Feb 01, 2011
A073019 001 Mar 30, 1994
A070985 001 Oct 02, 1987
A071163 001 Jul 15, 1986
A070481 001 Sep 24, 1986
A072096 001 Dec 08, 1987
A075995 001 Mar 14, 2002
A077349 001 Jun 21, 2005
A079129 001 Mar 28, 2011
A091355 001 Apr 04, 2011
A071229 001 Apr 01, 1987
A071639 001 Feb 02, 1988
A070435 001 Mar 05, 1986
A071214 001 Dec 01, 1986
N020267 002 Dec 13, 1996
A075367 001 Apr 22, 1999
N020602 001 Jun 10, 1996
N019012 003 Dec 17, 1990
N019012 004 Feb 25, 2000
A071265 001 Oct 15, 1986
A072095 001 Dec 08, 1987
N020944 001 Dec 18, 1998
N020601 001 Nov 15, 1996
A076359 001 Jan 16, 2004
A076359 002 Jan 16, 2004
N020944 002 Dec 18, 1998
N020601 003 Nov 15, 1996
N201803 001 Jun 12, 2012
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
TABLET;ORAL
ADVIL CONGESTION RELIEF
+ PFIZER 200MG;10MG N022565 001 May 27, 2010
IBUPROFEN
TABLET;ORAL
IBU-TAB 200
ALRA
IBUPROFEN
AMNEAL PHARMS NY
AVEMA PHARMA
CONTRACT PHARMACAL
DR REDDYS LA
DR REDDYS LABS INC
GRANULES INDIA
LNK
MARKSANS PHARMA
MCNEIL
MERRO PHARM
OHM
PAR PHARM
PERRIGO
PERRIGO R AND D
SVADS HOLDINGS SA
VINTAGE PHARMS
WATSON LABS
IBUPROHM
OHM LABS
JUNIOR STRENGTH ADVIL
PFIZER
JUNIOR STRENGTH IBUPROFEN
PERRIGO
JUNIOR STRENGTH MOTRIN
MCNEIL CONS
MOTRIN IB
+ MCNEIL
MOTRIN MIGRAINE PAIN
+ MCNEIL
PROFEN
CONTRACT PHARMACAL
TAB-PROFEN
PERRIGO
TABLET, CHEWABLE;ORAL
CHILDREN'S ADVIL
PFIZER
CHILDREN'S MOTRIN
MCNEIL CONS
IBUPROFEN
PERRIGO
JUNIOR STRENGTH ADVIL
PFIZER
JUNIOR STRENGTH MOTRIN
+ MCNEIL CONS
IBUPROFEN SODIUM
TABLET;ORAL
ADVIL
+ PFIZER CONS HLTHCARE
OTC DRUG PRODUCT LIST
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
100MG
200MG
100MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
100MG
100MG
100MG
200MG
200MG
200MG
200MG
50MG
50MG
50MG
100MG
100MG
100MG
EQ 200MG BASE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE;ORAL
ADVIL COLD AND SINUS
+ PFIZER
SUSPENSION;ORAL
CHILDREN'S ADVIL COLD
PFIZER
CHILDREN'S MOTRIN COLD
+ MCNEIL CONS
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
PERRIGO 100MG/5ML;15MG/5ML
TABLET;ORAL
ADVIL COLD AND SINUS
+ PFIZER 200MG;30MG
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
EQ 200MG FREE ACID AND POTASSIUM
SALT;30MG
100MG/5ML;15MG/5ML
100MG/5ML;15MG/5ML
CONTRACT PHARMACAL
DR REDDYS LABS LTD
IBUPROHM COLD AND SINUS
OHM LABS
SINE-AID IB
MCNEIL CONS
INSULIN RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN R
+ LILLY
HUMULIN R PEN
+ LILLY
NOVOLIN R
+ NOVO NORDISK INC
200MG;30MG
200MG;30MG
200MG;30MG
200MG;30MG
100 UNITS/ML
100 UNITS/ML
100 UNITS/ML
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN 70/30
+ LILLY 30 UNITS/ML;70 UNITS/ML
HUMULIN 70/30 PEN
+ LILLY 30 UNITS/ML;70 UNITS/ML
NOVOLIN 70/30
+ NOVO NORDISK INC 30 UNITS/ML;70 UNITS/ML
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN N
+ LILLY 100 UNITS/ML
NOVOLIN N
+ NOVO NORDISK INC 100 UNITS/ML
IODINE POVACRYLEX; ISOPROPYL ALCOHOL
SPONGE;TOPICAL
DURAPREP
+ 3M
+
KETOCONAZOLE
SHAMPOO;TOPICAL
NIZORAL A-D
+ MCNEIL CONS
KETOPROFEN
FILM;ORAL
NEXCEDE
+ NOVARTIS
KETOTIFEN FUMARATE
SOLUTION/DROPS;OPHTHALMIC
ALAWAY
+ BAUSCH AND LOMB
KETOTIFEN FUMARATE
AKORN
ALCON PHARMS LTD
ZADITOR
+ ALCON PHARMA
EQ 0.7% IODINE;74% (6ML)
EQ 0.7% IODINE;74% (26ML)
1%
12.5MG
EQ 0.025% BASE
EQ 0.025% BASE
EQ 0.025% BASE
EQ 0.025% BASE
N021374 001
N021373 001
N021128 001
A076478 001
N019771 001
A075588 001
A077628 001
A074567 001
N019899 001
N018780 001
N018780 005
N019938 001
N019717 001
N019717 002
N019991 001
N018781 001
N019959 001
N021586 001
N021586 002
N020310 001
N022470 001
N021996 001
A077958 001
A077200 001
N021066 002
4-10( of 17)
May 30, 2002
Apr 18, 2002
Aug 01, 2000
Nov 05, 2003
Sep 19, 1989
Apr 08, 2002
Aug 14, 2006
Apr 17, 2001
Dec 31, 1992
Oct 28, 1982
Aug 06, 1998
Jun 25, 1991
Apr 25, 1989
Aug 06, 1998
Jun 25, 1991
Oct 28, 1982
Jul 01, 1991
Sep 29, 2006
Sep 29, 2006
Oct 10, 1997
Nov 25, 2009
Dec 01, 2006
Jul 26, 2007
Sep 02, 2008
Oct 19, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
LANSOPRAZOLE
CAPSULE, DELAYED REL PELLETS;ORAL
LANSOPRAZOLE
DR REDDYS LABS LTD
PERRIGO R AND D
WOCKHARDT LTD
PREVACID 24 HR
+ NOVARTIS
LEVONORGESTREL
TABLET;ORAL
LEVONORGESTREL
LUPIN LTD
NOVEL LABS INC
PERRIGO R AND D
+ WATSON LABS
WATSON LABS INC
PLAN B
+ TEVA BRANDED PHARM
PLAN B ONE-STEP
+ TEVA BRANDED PHARM
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
LOPERAMIDE HYDROCHLORIDE
BANNER PHARMACAPS
+
SOLUTION;ORAL
IMODIUM A-D
+ MCNEIL CONS
LOPERAMIDE HYDROCHLORIDE
HI TECH PHARMA
PERRIGO
ROXANE
WOCKHARDT
SUSPENSION;ORAL
IMODIUM A-D
+ MCNEIL CONS
LOPERAMIDE HYDROCHLORIDE
PERRIGO R AND D
TABLET;ORAL
IMODIUM A-D
+ MCNEIL CONS
LOPERAMIDE HYDROCHLORIDE
CONTRACT PHARMACAL
LNK
OHM LABS
PERRIGO
TABLET, CHEWABLE;ORAL
IMODIUM A-D EZ CHEWS
+ MCNEIL
15MG
15MG
15MG
15MG
0.75MG
1.5MG
0.75MG
0.75MG
1.5MG
0.75MG
1.5MG
1MG
2MG
1MG/5ML
1MG/5ML
1MG/5ML
1MG/5ML
1MG/5ML
1MG/7.5ML
1MG/7.5ML
2MG
2MG
2MG
2MG
2MG
2MG
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
TABLET;ORAL
IMODIUM MULTI-SYMPTOM RELIEF
+ MCNEIL CONS 2MG;125MG
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
RANBAXY 2MG;125MG
TABLET, CHEWABLE;ORAL
IMODIUM MULTI-SYMPTOM RELIEF
+ MCNEIL 2MG;125MG
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
PERRIGO
LORATADINE
CAPSULE;ORAL
CLARITIN
+ SCHERING PLOUGH
SUSPENSION;ORAL
LORATADINE
+ TARO
SYRUP;ORAL
CLARITIN
+ SCHERING PLOUGH
2MG;125MG
10MG
1MG/ML
1MG/ML
4-11( of 17)
A202194 001 May 18, 2012
A202319 001 May 18, 2012
A202727 001 May 18, 2012
N022327 001 May 18, 2009
A091328 001 Jan 23, 2013
A202508 001 Feb 22, 2013
A090740 001 Dec 30, 2010
A078665 001 Aug 28, 2009
A200670 001 Jul 12, 2012
N021045 002 Aug 24, 2006
N021998 001 Jul 10, 2009
N021855 001 Aug 04, 2005
N021855 002 Aug 04, 2005
N019487 001 Mar 01, 1988
A074352 001 Nov 17, 1995
A073243 001 Jan 21, 1992
A073079 001 Apr 30, 1992
A074730 001 Aug 28, 1997
N019487 002 Jul 08, 2004
A091292 001 May 20, 2011
N019860 001 Nov 22, 1989
A073254 001 Jul 30, 1993
A076497 001 Jun 10, 2003
A074091 001 Dec 10, 1992
A075232 001 Jan 06, 2000
N020448 001 Jul 24, 1997
N021140 001 Nov 30, 2000
A077500 001 Sep 06, 2006
N020606 001 Jun 26, 1996
A076029 001 Aug 30, 2002
N021952 001 Jun 16, 2008
N021734 001 Oct 04, 2005
N020641 002 Nov 27, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-12( of 17)
LORATADINE
SYRUP;ORAL
LORATADINE
PERRIGO
SILARX
TARO
TEVA
WOCKHARDT
TABLET;ORAL
CLARITIN
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
A075728 001
A077421 001
A076805 001
A075505 001
A075815 001
Aug 20, 2004
Jun 29, 2006
Aug 20, 2004
Nov 07, 2003
Aug 20, 2004
SCHERING PLOUGH +
CLARITIN HIVES RELIEF
10MG N019658 002 Nov 27, 2002
SCHERING PLOUGH +
LORATADINE
10MG N019658 003 Nov 19, 2003
APOTEX INC
MYLAN
PERRIGO
RANBAXY
SANDOZ
TABLET, CHEWABLE;ORAL
CHILDREN'S CLARITIN
10MG
10MG
10MG
10MG
10MG
10MG
10MG
A076471 001
A075790 001
A076154 001
A078447 001
A076301 001
A076134 001
A075209 001
Feb 14, 2006
Nov 07, 2008
Aug 20, 2003
Aug 12, 2011
Jun 25, 2004
Aug 18, 2003
Jan 21, 2003
SCHERING PLOUGH 5MG +
TABLET, ORALLY DISINTEGRATING;ORAL
ALAVERT
N021891 001 Aug 23, 2006
PFIZER 10MG
CLARITIN HIVES RELIEF REDITAB
N021375 001 Dec 19, 2002
SCHERING PLOUGH +
CLARITIN REDITABS
10MG N020704 003 Nov 19, 2003
SCHERING PLOUGH +
+
LORATADINE
5MG
10MG
N021993 001
N020704 002
Dec 12, 2006
Nov 27, 2002
IMPAX LABS
PFIZER
WATSON LABS FLORIDA
LORATADINE REDIDOSE
10MG
10MG
10MG
A076011 001
A075822 001
A075990 001
Sep 29, 2003
Feb 10, 2003
Nov 03, 2003
RANBAXY 10MG A077153 001 Apr 11, 2007
LORATADINE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
CLARITIN-D
SCHERING PLOUGH +
CLARITIN-D 24 HOUR
5MG;120MG N019670 002 Nov 27, 2002
SCHERING PLOUGH 10MG;240MG +
LORATADINE AND PSEUDOEPHEDRINE SULFATE
N020470 002 Nov 27, 2002
IMPAX LABS
RANBAXY
WATSON LABS FLORIDA
5MG;120MG
10MG;240MG
10MG;240MG
10MG;240MG
A076050 001
A075989 001
A076557 001
A075706 001
Jan 30, 2003
Mar 04, 2004
Sep 22, 2004
Feb 21, 2003
MENTHOL; METHYL SALICYLATE
PATCH;TOPICAL
SALONPAS
+ HISAMITSU PHARM CO 3%;10%
3%;10%
N022029 001
N022029 002
Feb 20, 2008
Nov 05, 2012
MICONAZOLE NITRATE
CREAM;TOPICAL, VAGINAL
MICONAZOLE 3 COMBINATION PACK
PERRIGO 2%;4%
MONISTAT 3 COMBINATION PACK
A076357 001 Mar 30, 2004
INSIGHT PHARMS 2%;4%
MONISTAT 3 COMBINATION PACK (PREFILLED)
INSIGHT PHARMS 2%;4% +
CREAM;VAGINAL
MICONAZOLE 3
N021261 003
N021261 001
Jun 17, 2003
Feb 02, 2001
TARO
MICONAZOLE 7
4% A076773 001 Mar 02, 2005
ACTAVIS MID ATLANTIC
MICONAZOLE NITRATE
2% A074164 001 Mar 29, 1996
G AND W LABS INC
PERRIGO
PERRIGO R AND D
2%
2%
4%
A074366 001
A074760 001
A091366 001
Feb 22, 1996
May 15, 1997
Jan 15, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-13( of 17)
MICONAZOLE NITRATE
CREAM;VAGINAL
MICONAZOLE NITRATE
TARO 2% A074444 001 Jan 13, 1997
MONISTAT 3
+ INSIGHT PHARMS 4% N020827 001 Mar 30, 1998
MONISTAT 7
+ INSIGHT PHARMS 2% N017450 002 Feb 15, 1991
CREAM, SUPPOSITORY;TOPICAL, VAGINAL
M-ZOLE 3 COMBINATION PACK
ACTAVIS MID ATLANTIC 2%;200MG A074926 001 Apr 16, 1999
MICONAZOLE 7 COMBINATION PACK
G AND W LABS 100MG;2% A076585 001 Mar 26, 2004
MICONAZOLE NITRATE
PERRIGO R AND D 1.2GM;2% A079114 001 Jun 02, 2010
MICONAZOLE NITRATE COMBINATION PACK
PERRIGO 200MG;200MG A075329 001 Apr 20, 1999
MONISTAT 1 COMBINATION PACK
+ INSIGHT PHARMS 1.2GM;2% N021308 001 Jun 29, 2001
MONISTAT 7 COMBINATION PACK
+ INSIGHT PHARMS 100MG;2% N020288 002 Apr 26, 1993
MONISTAT-3 COMBINATION PACK
+ INSIGHT PHARMS 2%;200MG N020670 002 Apr 16, 1996
SUPPOSITORY;VAGINAL
MICONAZOLE NITRATE
ACTAVIS MID ATLANTIC
G AND W LABS
PERRIGO +
MONISTAT 7
100MG
100MG
100MG
A073507 001
A074414 001
A074395 001
Nov 19, 1993
Apr 30, 1997
Mar 20, 1997
+ INSIGHT PHARMS 100MG N018520 002 Feb 15, 1991
MINOXIDIL
AEROSOL, FOAM;TOPICAL
MEN'S ROGAINE
JOHNSON AND JOHNSON +
MINOXIDIL
5% N021812 001 Jan 20, 2006
PERRIGO ISRAEL 5%
SOLUTION;TOPICAL
MINOXIDIL (FOR MEN)
ACTAVIS MID ATLANTIC 2%
HI TECH PHARMA 2%
PERRIGO 2%
WOCKHARDT 2%
MINOXIDIL (FOR WOMEN)
HI TECH PHARMA 2%
PERRIGO 2%
MINOXIDIL EXTRA STRENGTH (FOR MEN)
ACTAVIS MID ATLANTIC 5%
AVACOR PRODS 5%
PERRIGO 5%
PERRIGO NEW YORK 5%
WOCKHARDT 5%
ROGAINE (FOR MEN)
JOHNSON AND JOHNSON 2% +
ROGAINE (FOR WOMEN)
JOHNSON AND JOHNSON 2% +
ROGAINE EXTRA STRENGTH (FOR MEN)
JOHNSON AND JOHNSON 5% +
THEROXIDIL
A091344 001
A074588 001
A074731 001
A075357 001
A074767 001
A074731 002
A075357 002
A075518 001
A075619 001
A075598 001
A075737 001
A075438 001
N019501 002
N019501 003
N020834 001
Apr 28, 2011
Apr 05, 1996
Dec 24, 1996
Jul 30, 1999
Feb 28, 1997
May 11, 2005
Jul 30, 1999
Nov 17, 2000
Nov 17, 2000
Jun 13, 2001
Mar 15, 2002
Feb 27, 2003
Feb 09, 1996
Feb 09, 1996
Nov 14, 1997
EI INC 2%
5%
A078176 001
A076239 001
Nov 09, 2007
Aug 24, 2004
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
SOLUTION/DROPS;OPHTHALMIC
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
AKORN INC
ALTAIRE PHARMS INC
NAPHCON-A
0.025%;0.3%
0.02675%;0.315%
A202795 001
A078208 001
Jan 24, 2013
Sep 27, 2010
ALCON +
OPCON-A
0.025%;0.3% N020226 001 Jun 08, 1994
BAUSCH AND LOMB +
VISINE-A
0.02675%;0.315% N020065 001 Jun 08, 1994
+ JOHNSON AND JOHNSON 0.025%;0.3% N020485 001 Jan 31, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-14( of 17)
NAPROXEN SODIUM
CAPSULE;ORAL
NAPROXEN SODIUM
+ BANNER PHARMACAPS EQ 200MG BASE N021920 001 Feb 17, 2006
TABLET;ORAL
ALEVE
+ BAYER EQ 200MG BASE N020204 002 Jan 11, 1994
NAPROXEN SODIUM
AMNEAL PHARMS NY EQ 200MG BASE A079096 001 Dec 16, 2008
CONTRACT PHARMACAL EQ 200MG BASE A074635 001 Jan 13, 1997
EQ 200MG BASE A074789 001 Feb 27, 1997
DR REDDYS LABS INC EQ 200MG BASE A075168 001 Jul 28, 1998
GRANULES INDIA EQ 200MG BASE A091353 001 Sep 20, 2011
MARKSANS PHARMA EQ 200MG BASE A090545 001 Mar 16, 2011
PERRIGO EQ 200MG BASE A074661 001 Jan 13, 1997
RANBAXY LABS LTD EQ 200MG BASE A091183 001 May 20, 2011
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ALEVE-D SINUS & COLD
+ BAYER 200MG;120MG N021076 001 Nov 29, 1999
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
DR REDDYS LABS INC EQ 220MG BASE;120MG A077381 001 Sep 27, 2006
PERRIGO EQ 200MG BASE;120MG A076518 001 Mar 17, 2004
NICOTINE
FILM, EXTENDED RELEASE;TRANSDERMAL
HABITROL
NOVARTIS +
+
+
NICODERM CQ
SANOFI AVENTIS US +
+
+
NICOTINE
7MG/24HR
14MG/24HR
21MG/24HR
7MG/24HR
14MG/24HR
21MG/24HR
N020076 004
N020076 005
N020076 006
N020165 006
N020165 005
N020165 004
Nov 12, 1999
Nov 12, 1999
Nov 12, 1999
Aug 02, 1996
Aug 02, 1996
Aug 02, 1996
AVEVA 7MG/24HR
14MG/24HR
21MG/24HR
A074612 002
A074612 003
A074612 001
Jul 28, 2003
Oct 20, 1997
Oct 20, 1997
NICOTINE POLACRILEX
GUM, CHEWING;BUCCAL
NICORETTE
GLAXOSMITHKLINE +
+
NICORETTE (MINT)
GLAXOSMITHKLINE
NICOTINE POLACRILEX
EQ 2MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 4MG BASE
N018612 002
N018612 004
N020066 002
N020066 004
N018612 003
N020066 003
Feb 09, 1996
Sep 25, 2000
Feb 09, 1996
Sep 25, 2000
Dec 23, 1998
Dec 23, 1998
IVAX SUB TEVA PHARMS
PERRIGO
PERRIGO R AND D
WATSON LABS
EQ 2MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
A076880 001
A077850 001
A076775 001
A076776 001
A076777 001
A076778 001
A076779 001
A076789 001
A078325 001
A078547 001
A078967 001
A091349 001
A078326 001
A078546 001
A078968 001
A091354 001
A074507 001
A076569 001
A078699 001
A079044 001
A079216 001
A074707 001
A076568 002
Feb 18, 2009
Feb 18, 2009
Sep 16, 2004
Sep 16, 2004
Sep 16, 2004
Sep 16, 2004
Sep 16, 2004
Sep 16, 2004
Oct 30, 2006
May 24, 2007
Apr 23, 2008
Jul 20, 2011
Oct 30, 2006
May 24, 2007
Apr 23, 2008
Jul 20, 2011
Mar 15, 1999
Jul 29, 2004
Dec 29, 2008
Jul 08, 2009
Jul 08, 2009
Mar 19, 1999
Jul 29, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
NICOTINE POLACRILEX
GUM, CHEWING;BUCCAL
NICOTINE POLACRILEX
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
THRIVE
NOVARTIS EQ 2MG BASE
EQ 4MG BASE
TROCHE/LOZENGE;ORAL
COMMIT
GLAXOSMITHKLINE CONS EQ 2MG BASE
+ EQ 4MG BASE
NICORETTE
GLAXOSMITHKLINE CONS EQ 2MG BASE
+ EQ 4MG BASE
NICOTINE POLACRILEX
PERRIGO R AND D EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
NIZATIDINE
TABLET;ORAL
AXID AR
+ PFIZER 75MG
NONOXYNOL-9
SPONGE;VAGINAL
TODAY
+ AZTIQ PHARMA 1GM
OMEPRAZOLE
TABLET, DELAYED RELEASE;ORAL
OMEPRAZOLE
+ DEXCEL PHARMA 20MG
OMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED RELEASE;ORAL
OMEPRAZOLE MAGNESIUM
+ DR REDDYS LABS LTD EQ 20MG BASE
TABLET, DELAYED RELEASE;ORAL
PRILOSEC OTC
+ ASTRAZENECA EQ 20MG BASE
OMEPRAZOLE; SODIUM BICARBONATE
CAPSULE;ORAL
ZEGERID OTC
+ MSD CONSUMER 20MG;1.1GM
FOR SUSPENSION;ORAL
ZEGERID OTC
+ MSD CONSUMER 20MG/PACKET;1.68GM/PACKET
ORLISTAT
CAPSULE;ORAL
ALLI
+ GLAXOSMITHKLINE CONS 60MG
OXYBUTYNIN
FILM, EXTENDED RELEASE;TRANSDERMAL
OXYTROL FOR WOMEN
+ MSD CONSUMER 3.9MG/24HR
OXYMETAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
OCUCLEAR
SCHERING PLOUGH 0.025%
VISINE L.R.
+ JOHNSON AND JOHNSON 0.025%
4-15( of 17)
A078697 001 Dec 29, 2008
A079038 001 Jul 08, 2009
A079219 001 Jul 08, 2009
A077658 001 Jun 19, 2007
A077656 001 Jun 19, 2007
N021330 001 Oct 31, 2002
N021330 002 Oct 31, 2002
N022360 001 May 18, 2009
N022360 002 May 18, 2009
A077007 001 Jan 31, 2006
A090711 001 Jul 10, 2009
A090821 001 Jul 10, 2009
A203690 001 Oct 09, 2012
A077007 002 Jan 31, 2006
A090711 002 Jul 10, 2009
A090821 002 Jul 10, 2009
A203690 002 Oct 09, 2012
N020555 001 May 09, 1996
N018683 001 Apr 01, 1983
N022032 001 Dec 04, 2007
A078878 001 Jun 05, 2009
N021229 001 Jun 20, 2003
N022281 001 Dec 01, 2009
N022283 001 Jun 17, 2013
N021887 001 Feb 07, 2007
N202211 001 Jan 25, 2013
N018471 001 May 30, 1986
N019407 001 Mar 31, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PERMETHRIN
LOTION;TOPICAL
NIX
+ INSIGHT PHARMS
PERMETHRIN
ACTAVIS MID ATLANTIC
PERRIGO NEW YORK
PIPERONYL BUTOXIDE; PYRETHRINS
AEROSOL;TOPICAL
RID MOUSSE
+ BAYER
POLYETHYLENE GLYCOL 3350
FOR SOLUTION;ORAL
GLYCOLAX
KREMERS URBAN PHARMS
MIRALAX
+ SCHERING PLOUGH
POLYETHYLENE GLYCOL 3350
EMCURE PHARMS USA
MYLAN
NEXGEN PHARMA
NOVEL LABS INC
PAR PHARM
PERRIGO R AND D
POTASSIUM IODIDE
SOLUTION;ORAL
THYROSHIELD
+ ARCO PHARMS LLC
TABLET;ORAL
IOSAT
ANBEX
+
THYROSAFE
+ RECIP
POVIDONE-IODINE
SOLUTION;TOPICAL
POVIDONE IODINE
+ ALLEGIANCE HLTHCARE
SPONGE;TOPICAL
E-Z SCRUB 201
+ BECTON DICKINSON
E-Z SCRUB 241
+ BECTON DICKINSON
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
OTC DRUG PRODUCT LIST
1%
1%
1%
4%;EQ 0.33% BASE
17GM/PACKET
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/PACKET
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/PACKET
17GM/SCOOPFUL
65MG/ML
65MG
130MG
65MG
1%
20%
10%
PSEUDOEPHEDRINE HYDROCHLORIDE
PERRIGO
RANBAXY
SUDAFED 12 HOUR
+ MCNEIL CONS
SUDAFED 24 HOUR
+ MCNEIL CONS
PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
AFRINOL
+ SCHERING PLOUGH
PURIFIED WATER
SOLUTION;OPHTHALMIC
PUR-WASH
+ NIAGARA PHARMS
120MG
120MG
120MG
240MG
120MG
98.3%
4-16( of 17)
N019918 001 May 02, 1990
A075014 001 Mar 28, 2000
A076090 001 Dec 20, 2001
N021043 001 Mar 07, 2000
A090600 001 Oct 06, 2009
A090600 002 Oct 06, 2009
N022015 001 Oct 06, 2006
A202071 001 Dec 28, 2012
A078915 001 Oct 06, 2009
A078915 002 Oct 06, 2009
A090812 001 Oct 07, 2009
A091077 001 Oct 06, 2009
A079214 001 Jan 31, 2013
A090685 001 Oct 06, 2009
A090685 002 Oct 06, 2009
A077218 001 Jan 12, 2005
N018664 002 May 12, 2011
N018664 001 Oct 14, 1982
A076350 001 Sep 10, 2002
N019522 001 Mar 31, 1989
N019240 001 Nov 29, 1985
N019476 001 Jan 07, 1987
A075153 001 Feb 26, 1999
A077442 001 Sep 28, 2005
A073585 001 Oct 31, 1991
N020021 002 Dec 15, 1992
N018191 001
N022305 001 Sep 01, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-17( of 17)
RANITIDINE HYDROCHLORIDE
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
APOTEX INC
CONTRACT PHARMACAL
DR REDDYS LABS LTD
IVAX SUB TEVA PHARMS
MYLAN
PERRIGO
PERRIGO R AND D
SHASUN CHEMS
SVADS HOLDINGS SA
TORPHARM
WOCKHARDT
ZANTAC 150
EQ 150MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 150MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 150MG BASE
A200172 001
A075094 001
A075294 001
A078192 001
A075296 001
A075497 001
A076195 001
A091429 001
A091429 002
A201745 001
A200536 001
A075167 001
A076760 001
A078884 001
A078653 001
May 31, 2012
Jun 21, 1999
Mar 28, 2000
Aug 31, 2007
Jan 14, 2000
Jan 14, 2000
Aug 30, 2002
May 11, 2011
May 11, 2011
Feb 29, 2012
Jun 28, 2011
May 04, 2000
Feb 24, 2006
Jul 31, 2008
Nov 26, 2007
BOEHRINGER INGELHEIM +
ZANTAC 75
EQ 150MG BASE
EQ 150MG BASE
N021698 001
N021698 002
Aug 31, 2004
Mar 13, 2007
BOEHRINGER INGELHEIM EQ 75MG BASE N020520 001 Dec 19, 1995
SODIUM CHLORIDE
AEROSOL, METERED;INHALATION
BRONCHO SALINE
+ BLAIREX 0.9% N019912 001 Sep 03, 1992
SODIUM FLUORIDE; TRICLOSAN
PASTE;DENTAL
COLGATE TOTAL
+ COLGATE PALMOLIVE 0.24%;0.3% N020231 001 Jul 11, 1997
TERBINAFINE
GEL;TOPICAL
LAMISIL AT
+ NOVARTIS 1% N021958 001 Jul 24, 2006
TERBINAFINE HYDROCHLORIDE
CREAM;TOPICAL
LAMISIL
NOVARTIS +
TERBINAFINE HYDROCHLORIDE
1% N020980 001 Mar 09, 1999
TARO
SOLUTION;TOPICAL
LAMISIL AT
1% A077511 001 Jul 02, 2007
NOVARTIS +
SPRAY;TOPICAL
LAMISIL AT
1% N021124 001 Mar 17, 2000
+ NOVARTIS 1% N021124 002 Mar 17, 2000
TIOCONAZOLE
OINTMENT;VAGINAL
TIOCONAZOLE
PERRIGO
VAGISTAT-1
6.5% A075915 001 Nov 21, 2001
+ NOVARTIS 6.5% N020676 001 Feb 11, 1997
TRIAMCINOLONE ACETONIDE
SPRAY, METERED;NASAL
NASACORT ALLERGY 24 HOUR
SANOFI AVENTIS US 0.055MG/SPRAY N020468 002 Oct 11, 2013

34TH EDI TI ON - 2014 - APPROVED DRUG PRODUCT LI ST
5 - 1 of 5
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT
ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST
ANTI COAGULANT 4%SODI UM CI TRATE SOLUTI ON USP
I NJ ECTABLE; I NJ ECTI ON
NONE
HAEMONETI CS
MANUFACTURI NG I NC
N760305 J un 30, 1978
ANTI COAGULANT CI TRATE DEXTROSE SOLUTI ON ( ACD)
I NJ ECTABLE; I NJ ECTI ON
CI TRA LABS LLC
ACD- A SOLUTI ON
TERUMO BCT I NC
ADSOL WI TH ACD- A
FENWAL I NC
ANTI COAGULANT CI TRATE DEXTROSE SOLUTI ON FORMULA A
HAEMONETI CS CORP
AS3 SOLUTI ON/ ACD- A
TERUMO BCT I NC
N020037
A010228
N000922
A980728
N001214
ANDA
ANDA
Aug 26, 2003
Feb 25, 2002
Aug 29, 2002
Feb 06, 2002
May 29, 2002
ANTI COAGULANT CI TRATE DEXTROSE SOLUTI ON USP
I NJ ECTABLE; I NJ ECTI ON
NONE
FENWAL I NC
FRESENI US MEDI CAL
CARE NORTH AMERI CA
MI LES I NC
N100855
N160918
N110912
N100102
J un 03, 1959
Mar 17, 1978
Sep 02, 1959
Dec 14, 1961
ANTI COAGULANT CI TRATE DEXTROSE SOLUTI ON USP ( ACD- A)
I NJ ECTABLE; I NJ ECTI ON
NONE
ARTERI OCYTE MEDI CAL
SYSTEMS, I NC
A110057 May 11, 2012
ANTI COAGULANT CI TRATE PHOSPHATE 2X DEXTROSE SOLUTI ON ( CP2D)
I NJ ECTABLE; I NJ ECTI ON
CI TRATE PHOSPHATE DOUBLE DEXTROSE/ ADDI TI VE SOLUTI ON 3
HAEMONETI CS CORP N000127 J an 18, 2002
ANTI COAGULANT CI TRATE PHOSPHATE DEXTROSE ADENI NE SOLUTI ON
I NJ ECTABLE; I NJ ECTI ON
NONE
FRESENI US MEDI CAL
CARE NORTH AMERI CA
TERUMO MEDI CAL CORP
N780519
N820528
Apr 23, 1980
Nov 03, 1982
ANTI COAGULANT CI TRATE PHOSPHATE DEXTROSE ADENI NE SOLUTI ON ( CPDA)
I NJ ECTABLE; I NJ ECTI ON
CPDA- 1 BLOOD- PACK UNI T ( PL 146 PLASTI C) 250, 450, 500 ML BLOOD PACK UNI TS
FENWAL I NC N770420 May 12, 1978
ANTI COAGULANT CI TRATE PHOSPHATE DEXTROSE ADENI NE SOLUTI ON USP
I NJ ECTABLE; I NJ ECTI ON
BLOOD PACK UNI T CPDA- 1 I N PLASTI C CONTAI NER
FENWAL I NC N940404 J ul 28, 1994

34TH EDI TI ON - 2014 - APPROVED DRUG PRODUCT LI ST
5 - 2 of 5
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT
ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST
ANTI COAGULANT CI TRATE PHOSPHATE DEXTROSE ADENI NE- 1 SOLUTI ON
I NJ ECTABLE; I NJ ECTI ON
NONE
HAEMONETI CS N800077 Nov 06, 1980
MANUFACTURI NG I NC
ANTI COAGULANT CI TRATE PHOSPHATE DEXTROSE SOLUTI ON
I NJ ECTABLE; I NJ ECTI ON
ADSOL I N PLASTI C CONTAI NER
FENWAL I NC N900223 Dec 27, 1991
ANTI COAGULANT CI TRATE PHOSPHATE DEXTROSE SOLUTI ON ( CPD)
I NJ ECTABLE; I NJ ECTI ON
MACOPRODUCTI ONS SAS CPD/ AS- 1: MACOPHARMA LEUCOFLEX MTL1 LEUKOREDUCTI ON SYSTEM FOR BLOOD
COMPONENTS KNOWN AS MTL1- WB
MACOPRODUCTI ONS SAS N040083 Nov 21, 2005
NONE
TERUMO BCT I NC A070025 J an 06, 2008
ANTI COAGULANT CI TRATE PHOSPHATE DEXTROSE SOLUTI ON USP
I NJ ECTABLE; I NJ ECTI ON
NONE
FENWAL I NC N170401 Dec 06, 1977
N811012 J un 28, 1983
FRESENI US MEDI CAL N160907 May 16, 1973
CARE NORTH AMERI CA
HAEMONETI CS N800222 Aug 23, 1982
MANUFACTURI NG I NC
MI LES I NC N160527 J un 22, 1970
TERUMO MEDI CAL CORP N781211 J un 10, 1981
ANTI COAGULANT CI TRATE PHOSPHATE DEXTROSE SOLUTI ON USP WI TH: AS- 1:
DEXTROSE USP; SODI UM CHLORI DE USP; MANNI TOL USP; ADENI NE
I NJ ECTABLE; I NJ ECTI ON
ADSOL RED BLOOD CELL PRESERVATI VE SOLUTI ON
FENWAL I NC N811104 May 16, 1983
ANTI COAGULANT CI TRATE PHOSPHATE DEXTROSE SOLUTI ON USP WI TH: AS- 5:
DEXTROSE USP; SODI UM CHLORI DE USP; MANNI TOL USP; ADENI NE
I NJ ECTABLE; I NJ ECTI ON
OPTI SOL RED BLOOD CELL PRESERVATI VE SOLUTI ON
TERUMO MEDI CAL CORP N880217 Oct 07, 1988
ANTI COAGULANT CI TRATE PHOSPHATE DOUBLE DEXTROSE SOLUTI ON WI TH:
AS- 3: CI TRI C ACI D USP; MONOBASI C SODI UM PHOSPHATE USP; SODI UM CHLORI DE USP; ADENI NE;
DEXTROSE USP; SODI UM CI TRATE USP
I NJ ECTABLE; I NJ ECTI ON
AS- 3 NUTRI CEL ADDI TI VE SYSTEM
HAEMONETI CS 0. 042GM/ 100ML; 0. 276GM/ 100ML; N820915 Oct 19, 1984
MANUFACTURI NG I NC 0. 410GM/ 100ML; 0. 30GM/ 100ML;
1. 10GM/ 100ML; 0. 588GM/ 100ML
ANTI COAGULANT CI TRATE PHOSPHATE DOUBLE DEXTROSE SOLUTI ON WI TH:
AS- 2: CI TRI C ACI D USP; DI BASI C SODI UM PHOSPHATE USP; SODI UM CHLORI DE USP; ADENI NE;
DEXTROSE USP; SODI UM CI TRATE USP
I NJ ECTABLE; I NJ ECTI ON
AS- 2 NUTRI CEL ADDI TI VE SYSTEM
MEDSEP CORP 0. 042GM/ 100ML; 0. 285GM/ 100ML; N820915 Sep 22, 1983
0. 718GM/ 100ML; 0. 017GM/ 100ML;
0. 396GM/ 100ML; 0. 588GM/ 100ML

34TH EDI TI ON - 2014 - APPROVED DRUG PRODUCT LI ST
5 - 3 of 5
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT
ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST
ANTI COAGULANT ETHYLENEDI AMI NE TETRAACETI C ACI D ( EDTA)
I NJ ECTABLE; I NJ ECTI ON
NONE
FENWAL I NC N090480 Mar 07, 1955
ANTI COAGULANT HEPARI N SOLUTI ON USP
I NJ ECTABLE; I NJ ECTI ON
NONE
FRESENI US MEDI CAL
CARE NORTH AMERI CA
N770822 May 17, 1978
ANTI COAGULANT SODI UM CI TRATE 4%SOLUTI ON
I NJ ECTABLE; I NJ ECTI ON
NONE
HAEMONETI CS
CORPORATI ON
N980123 Mar 03, 2000
ANTI COAGULANT SODI UM CI TRATE SOLUTI ON
I NJ ECTABLE; I NJ ECTI ON
TRI CI TRASOL
CYTOSOL
LABORATORI ES I NC
N010409 J ul 10, 2003
ANTI COAGULANT SODI UM CI TRATE SOLUTI ON USP
I NJ ECTABLE; I NJ ECTI ON
NONE
FENWAL I NC
FRESENI US MEDI CAL
CARE NORTH AMERI CA
TERUMO MEDI CAL CORP
N770923
N160702
N781214
J an 20, 1978
Dec 28, 1970
Feb 08, 1980
DEXTRAN 1 I N SODI UM CHLORI DE 0. 6%
I NJ ECTABLE; I NJ ECTI ON
PROMI T
MEDA AB N830715 Oct 30, 1984
DEXTRAN 40, 10%I N DEXTROSE 5%
I NJ ECTABLE; I NJ ECTI ON
GENTRAN 40
BAXTER HLTHCARE CORP 10GM/ 100ML; 5GM/ 100ML
LMD I N GLASS BOTTLE
HOSPI RA I NC 10GM/ 100ML; 5GM/ 100ML
NONE
B BRAUN MEDI CAL I NC 10GM/ 100ML; 5GM/ 100ML
HOSPI RA I NC 10GM/ 100ML; 5GM/ 100ML
MI LES I NC 10GM/ 100ML; 5GM/ 100ML
PHARMACHEM CORP 10GM/ 100ML; 5GM/ 100ML
N840619
A720563
N160767
N160375
N160653
N160836
ANDA
Feb 22, 1985
Oct 30, 1992
Apr 06, 1970
J ul 25, 1967
Sep 23, 1969
Nov 14, 1972

34TH EDI TI ON - 2014 - APPROVED DRUG PRODUCT LI ST
5 - 4 of 5
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT
ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST
DEXTRAN 40, 10%I N SODI UM CHLORI DE 0. 9%
I NJ ECTABLE; I NJ ECTI ON
GENTRAN 40
BAXTER HLTHCARE CORP 10GM/ 100ML; 0. 9GM/ 100ML
LMD I N PLASTI C CONTAI NER
HOSPI RA I NC 10GM/ 100ML; 0. 9GM/ 100ML
NONE
N840620
A720562 ANDA
Feb 22, 1985
Oct 30, 1992
B BRAUN MEDI CAL I NC
HOSPI RA I NC
MI LES I NC
PHARMACHEM CORP
10GM/ 100ML; 0. 9GM/ 100ML
10GM/ 100ML; 0. 9GM/ 100ML
10GM/ 100ML; 0. 9GM/ 100ML
10GM/ 100ML; 0. 9GM/ 100ML
N160767
N160375
N160653
N160836
Apr 06, 1970
J ul 25, 1967
Sep 23, 1969
Nov 14, 1972
DEXTRAN 70, 6%I N SODI UM CHLORI DE 0. 9%
I NJ ECTABLE; I NJ ECTI ON
GENTRAI N 70
BAXTER HLTHCARE CORP
NONE
N160607 J an 26, 1970
B BRAUN MEDI CAL I NC
MI LES I NC
6GM/ 100ML; 0. 9 GM/ 100ML
6GM/ 100ML; 0. 9 GM/ 100ML
N090024
N080716
Aug 18, 1969
Mar 13, 1953
DEXTRAN 75, 6%I N SODI UM CHLORI DE 0. 9%
I NJ ECTABLE; I NJ ECTI ON
NONE
PHARMACHEM CORP 6GM/ 100ML; 0. 9GM/ 100ML
6GM/ 100ML; 0. 9GM/ 100ML
N080564
N160759
Sep 19, 1952
Aug 19, 1970
HETASTARCH 6%I N LACTATED ELECTROLYTE I NJ ECTI ON
I NJ ECTABLE; I NJ ECTI ON
HEXTEND
BI OTI ME I NC 6GM/ 100ML N200952 Mar 31, 1999
HETASTARCH 6%I N SODI UM CHLORI DE 0. 9%
I NJ ECTABLE; I NJ ECTI ON
6%HETASTARCH I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER
HOSPI RA I NC
HESPAN
6GM/ 100ML; 0. 9GM/ 100ML A740193 ANDA J an 30, 1995
B BRAUN MEDI CAL I NC 6GM/ 100ML; 0. 9GM/ 100ML
HESPAN I N PLASTI C CONTAI NER
N160889 J ul 17, 1972
B BRAUN MEDI CAL I NC
NONE
6GM/ 100ML; 0. 9GM/ 100ML N890105 Apr 04, 1991
B BRAUN MEDI CAL I NC
TEVA PARENTERAL
MEDI CI NES I NC
6GM/ 100ML; 0. 9GM/ 100ML
6GM/ 100ML; 0. 9GM/ 100ML
A740283
A740592
ANDA
ANDA
Oct 21, 1998
Nov 12, 1998
HETASTARCH 6%I N SODI UM CHLORI DE 0. 9%NACL 500 ML GLASS BOTTLES
I NJ ECTABLE; I NJ ECTI ON
NONE
HOSPI RA I NC 6GM/ 100ML; 0. 9 GM/ 100ML A720746 ANDA Feb 07, 1996
HYDROXYETHYL STARCH 130/ 0. 4 I N 6%SODI UM CHLORI DE 0. 9%
I NJ ECTABLE; I NJ ECTI ON
VOLUVEN
FRESENI US KABI
DEUTSCHLAND GMBH
6GM/ 100ML; 0. 9GM/ 100ML N070012 NDA Dec 27, 2007

34TH EDI TI ON - 2014 - APPROVED DRUG PRODUCT LI ST
5 - 5 of 5
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT
ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST
I SOPLATE SOLUTI ON I N THE 500 ML EXCEL CONTAI NER
I NJ ECTABLE; I NJ ECTI ON
I SOPLATE SOLUTI ON
HAEMONETI CS CORP N90067 Mar 05, 2013
LEUKOCYTE REDUCTI ON FI LTRATI ON SYSTEM FOR WHOLE BLOOD WI TH CPD ANTI COAGULANT AND
SOLX ADDI TI VE
I NJ ECTABLE; I NJ ECTI ON
LEUKOSEP HWB- 600- XL
HAEMONETI CS CORP N110059 Apr 25, 2013
PENTASTARCH 10%I N SODI UM CHLORI DE 0. 9%
I NJ ECTABLE; I NJ ECTI ON
PENTASPAN
B BRAUN MEDI CAL I NC 10GM/ 100ML; 0. 9GM/ 100ML
PENTASPAN I N PLASTI C CONTAI NER
N841207 May 19, 1987
B BRAUN MEDI CAL I NC 10GM/ 100ML; 0. 9GM/ 100ML N890104 Apr 04, 1991
PERFLUORODECALI N; PERFLUOROTRI - N- PROPYLAMI NE
I NJ ECTABLE; I NJ ECTI ON
FLUOSOL
ALPHA THERAPEUTI C
CORP
17. 5GM/ 100ML; 7. 5GM/ 100ML N860909 Dec 26, 1989
RED BLOOD CELL PROCESSI NG SOLUTI ON
I NJ ECTABLE; I NJ ECTI ON
REJ UVESOL
CI TRA LABS LLC N950522 Feb 26, 1997
SODI UM CHLORI DE; SODI UM ACETATE; SODI UM CI TRATE DI HYDRATE; SODI UM PHOSPHATE,
DI ABASI C ANHYDROUS; SODI UM PHOSPHATE MONOBASI C, MONOHYDRATE
I NJ ECTABLE; I NJ ECTI ON
I NTERSOL SOLUTI ON
FENWAL I NC. 2. 26G/ 500ML; 2. 21G/ 500ML; 1. 59G/ 500ML; N080041 NDA Dec 09, 2009
1. 53G/ 500ML; 0. 465G/ 500ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-1( of 322)
ABARELIX
INJECTABLE;INTRAMUSCULAR
PLENAXIS
SPECIALITY EUROPEAN 100MG/VIAL N021320 001 Nov 25, 2003
ACETAMINOPHEN
INJECTABLE;INJECTION
INJECTAPAP
ORTHO MCNEIL PHARM
SUPPOSITORY;RECTAL
ACEPHEN
100MG/ML N017785 001 Mar 07, 1986
G AND W LABS
ACETAMINOPHEN
120MG A072218 001 Mar 27, 1992
ABLE
ROXANE
TYLENOL
120MG
325MG
650MG
120MG
650MG
A073106 001
A073107 001
A073108 001
A071010 001
A071011 001
Feb 27, 1995
Feb 27, 1995
Feb 27, 1995
May 12, 1987
May 12, 1987
MCNEIL CONS 120MG N017756 002
650MG N017756 001
TABLET, EXTENDED RELEASE;ORAL
ACETAMINOPHEN
RANBAXY 650MG A090205 001 Nov 18, 2009
ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE
CAPSULE;ORAL
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
MIKART 150MG;180MG;15MG
150MG;180MG;30MG
150MG;180MG;60MG
CODEINE, ASPIRIN, APAP FORMULA NO. 2
SCHERER LABS 150MG;180MG;15MG
CODEINE, ASPIRIN, APAP FORMULA NO. 3
SCHERER LABS 150MG;180MG;30MG
CODEINE, ASPIRIN, APAP FORMULA NO. 4
SCHERER LABS 150MG;180MG;60MG
A081095 001
A081096 001
A081097 001
A085640 001
A085639 001
A085638 001
Oct 26, 1990
Oct 26, 1990
Oct 26, 1990
ACETAMINOPHEN; BUTALBITAL
CAPSULE;ORAL
BANCAP
FOREST PHARMS
BUCET
325MG;50MG A088889 001 Jan 16, 1986
MALLINCKRODT
TENCON
650MG;50MG A088991 001 Jun 28, 1985
MALLINCKRODT
TRIAPRIN
650MG;50MG A089405 001 May 15, 1990
DUNHALL 325MG;50MG
TABLET;ORAL
BUTALBITAL AND ACETAMINOPHEN
A089268 001 Jul 02, 1987
HALSEY
WATSON LABS
PHRENILIN
325MG;50MG
325MG;50MG
A089568 001
A087550 001
Oct 05, 1988
Oct 19, 1984
VALEANT
SEDAPAP
325MG;50MG A087811 001 Jun 19, 1985
MAYRAND 650MG;50MG A088944 001 Oct 17, 1985
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
ANOQUAN
SHIRE 325MG;50MG;40MG
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
GRAHAM DM 325MG;50MG;40MG
325MG;50MG;40MG
325MG;50MG;40MG
MALLINCKRODT 325MG;50MG;40MG
WEST WARD 500MG;50MG;40MG
BUTALIBITAL, ACETAMINOPHEN AND CAFFEINE
GILBERT LABS 325MG;50MG;40MG
FEMCET
A087628 001
A088743 001
A088765 001
A089067 001
A088758 001
A040261 001
A088825 001
Oct 01, 1986
Jul 18, 1985
Mar 27, 1985
Apr 19, 1985
Mar 27, 1985
Oct 28, 1998
Dec 05, 1984
MALLINCKRODT
MEDIGESIC PLUS
325MG;50MG;40MG A089102 001 Jun 19, 1985
US CHEM 325MG;50MG;40MG A089115 001 Jan 14, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
TRIAD
MALLINCKRODT 325MG;50MG;40MG
TABLET;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ABLE
GILBERT LABS
MIRROR PHARMS LLC
MUTUAL PHARM
WATSON LABS
WEST WARD
ESGIC
FOREST PHARMS
325MG;50MG;40MG
500MG;50MG;40MG
325MG;50MG;40MG
500MG;50MG;40MG
325MG;50MG;40MG
325MG;50MG;40MG
500MG;50MG;40MG
325MG;50MG;40MG
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE;ORAL
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ABLE 325MG;50MG;40MG;30MG
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
CAPSULE;ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
MIKART 356.4MG;30MG;16MG
WRASER PHARMS LLC 356.4MG;30MG;16MG
DHC PLUS
PHARM RES ASSOC 356.4MG;30MG;16MG
SYNALGOS-DC-A
LEITNER PHARMS 356.4MG;30MG;16MG
TABLET;ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
BOCA PHARMA LLC 712.8MG;60MG;32MG
MIKART 712.8MG;60MG;32MG
WEST-WARD PHARM CORP 712.8MG;60MG;32MG
ACETAMINOPHEN; CODEINE PHOSPHATE
CAPSULE;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
TEVA
PHENAPHEN W/ CODEINE NO. 2
ROBINS AH
PHENAPHEN W/ CODEINE NO. 3
ROBINS AH
PHENAPHEN W/ CODEINE NO. 4
ROBINS AH
PROVAL #3
SOLVAY
TYLENOL W/ CODEINE NO. 3
ORTHO MCNEIL PHARM
TYLENOL W/ CODEINE NO. 4
ORTHO MCNEIL PHARM
SOLUTION;ORAL
300MG;15MG
300MG;30MG
300MG;60MG
325MG;15MG
325MG;30MG
325MG;60MG
325MG;30MG
300MG;30MG
300MG;60MG
ACETAMINOPHEN AND CODEINE PHOSPHATE
ACTAVIS MID ATLANTIC
CLONMEL
ROXANE
TYLENOL W/ CODEINE
ORTHO MCNEIL PHARM
SUSPENSION;ORAL
CAPITAL AND CODEINE
ACTAVIS MID ATLANTIC
TABLET;ORAL
120MG/5ML;12MG/5ML
120MG/5ML;12MG/5ML
120MG/5ML;12MG/5ML
120MG/5ML;12MG/5ML
120MG/5ML;12MG/5ML
ACETAMINOPHEN AND CODEINE PHOSPHATE
ABLE 300MG;30MG
300MG;60MG
AM THERAP 300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
6-2( of 322)
A089023 001 Jun 19, 1985
A040390 001 Jul 23, 2001
A040394 001 Jul 23, 2001
A087629 001 Nov 13, 1984
A040883 001 Dec 23, 2008
A040601 001 Jul 29, 2005
A089536 001 Feb 16, 1988
A040336 001 Aug 18, 1999
A089660 001 Dec 23, 1988
A076528 001 Aug 21, 2003
A040109 001 Aug 26, 1997
A040688 001 Apr 03, 2007
A088584 001 Mar 04, 1986
A089166 001 May 14, 1986
A040701 001 Apr 03, 2007
A040316 001 Apr 28, 1999
A040637 001 Sep 22, 2006
A088537 001 Jun 04, 1984
A088324 001 Dec 29, 1983
A088599 001 Jun 01, 1984
A084444 001
A084445 001
A084446 001
A085685 001
A087422 001
A087421 001
A085861 001
A040098 001 Sep 20, 1996
A086366 001
A085057 001
A085883 001
A040452 001 Aug 01, 2002
A040459 001 Aug 01, 2002
A089478 001 Mar 03, 1987
A089481 001 Mar 03, 1987
A089479 001 Mar 03, 1987
A089482 001 Mar 03, 1987
A089480 001 Mar 03, 1987
A089483 001 Mar 03, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-3( of 322)
ACETAMINOPHEN; CODEINE PHOSPHATE
TABLET;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
DURAMED PHARMS BARR
EVERYLIFE
HALSEY
KV PHARM
LEDERLE
MIKART
MUTUAL PHARM
PURACAP PHARM
PUREPAC PHARM
ROXANE
SANDOZ
SUPERPHARM
USL PHARMA
VALEANT PHARM INTL
VITARINE
WARNER CHILCOTT
WATSON LABS
WATSON LABS FLORIDA
WHITEWORTH TOWN PLSN
300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
325MG;30MG
300MG;15MG
300MG;30MG
300MG;60MG
300MG;30MG
300MG;60MG
325MG;15MG
325MG;45MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
300MG;30MG
300MG;30MG
300MG;60MG
650MG;30MG
650MG;60MG
300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
300MG;30MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;15MG
300MG;30MG
300MG;60MG
500MG;15MG
500MG;30MG
500MG;60MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
300MG;60MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
300MG;30MG
300MG;60MG
300MG;30MG
300MG;30MG
300MG;15MG
300MG;30MG
300MG;60MG
300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
300MG;15MG
300MG;30MG
300MG;60MG
300MG;30MG
300MG;60MG
A040223 001
A088353 001
A040223 002
A088354 001
A040223 003
A088355 001
A085217 001
A083871 001
A083872 001
A086549 001
A085288 001
A085365 001
A085364 001
A085363 001
A087141 001
A089238 001
A089244 001
A089231 001
A089363 001
A085795 001
A089671 001
A085794 001
A089672 001
A087653 001
A089673 001
A087762 001
A086681 001
A089080 001
A086683 001
A084659 001
A084656 001
A084667 001
A089511 001
A089512 001
A089513 001
A087433 001
A081250 001
A085291 002
A085917 001
A081249 001
A085964 001
A087423 001
A089183 001
A089184 001
A089253 001
A089185 001
A089254 001
A087919 001
A087920 001
A085896 001
A085676 001
A085992 001
A085218 002
A087306 001
A087277 001
A089997 001
A087276 001
A089998 001
A087275 001
A089999 001
A040443 001
A040443 002
A040443 003
A084360 001
A085607 001
Nov 18, 1997
Feb 06, 1984
Nov 18, 1997
Feb 06, 1984
Nov 18, 1997
Feb 06, 1984
Feb 25, 1986
Feb 25, 1986
Mar 03, 1986
Sep 09, 1991
Feb 10, 1988
Feb 10, 1988
Apr 13, 1982
Feb 10, 1988
Dec 10, 1982
Jul 17, 1986
Apr 25, 1989
Apr 25, 1989
Apr 25, 1989
Jul 16, 1992
Jul 16, 1992
Oct 18, 1985
Oct 18, 1985
May 19, 1986
Oct 18, 1985
May 19, 1986
Jun 22, 1982
Jun 22, 1982
May 26, 1982
Dec 28, 1994
May 26, 1982
Dec 28, 1994
May 26, 1982
Dec 28, 1994
Jan 22, 2003
Jan 22, 2003
Jan 22, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-4( of 322)
ACETAMINOPHEN; CODEINE PHOSPHATE
TABLET;ORAL
CAPITAL AND CODEINE
CARNRICK
CODRIX
325MG;30MG A083643 001
WATSON LABS FLORIDA 500MG;15MG
500MG;30MG
500MG;60MG
EMPRACET W/ CODEINE PHOSPHATE #3
GLAXOSMITHKLINE 300MG;30MG
EMPRACET W/ CODEINE PHOSPHATE #4
GLAXOSMITHKLINE 300MG;60MG
PAPA-DEINE #3
A040447 001
A040441 001
A040488 001
A083951 001
A083951 002
Feb 26, 2003
Mar 27, 2003
Mar 28, 2003
VANGARD
PAPA-DEINE #4
300MG;30MG A088037 001 Mar 20, 1984
VANGARD
PHENAPHEN-650 W/ CODEINE
ROBINS AH
TYLENOL W/ CODEINE
ORTHO MCNEIL PHARM
TYLENOL W/ CODEINE NO. 1
JANSSEN PHARMS
TYLENOL W/ CODEINE NO. 2
JANSSEN PHARMS
300MG;60MG
650MG;30MG
325MG;7.5MG
325MG;15MG
325MG;30MG
325MG;60MG
300MG;7.5MG
300MG;15MG
A088715 001
A085856 001
A085056 001
A085056 002
A085056 003
A085056 004
A085055 001
A085055 002
Mar 20, 1984
ACETAMINOPHEN; HYDROCODONE BITARTRATE
CAPSULE;ORAL
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
CENT PHARMS
ALLAY
500MG;5MG A088898 001 Mar 27, 1985
IVAX PHARMS
BANCAP HC
500MG;5MG A089907 001 Jan 13, 1989
FOREST PHARMS
CO-GESIC
500MG;5MG A087961 001 Mar 17, 1983
CENT PHARMS 500MG;5MG
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
A089360 001 Mar 02, 1988
MALLINCKRODT
MIKART
LORCET-HD
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
A088956 001
A089006 001
A081067 001
A081068 001
A081069 001
A081070 001
A089008 001
Jul 19, 1985
Aug 09, 1985
Nov 30, 1989
Nov 30, 1989
Nov 30, 1989
Nov 30, 1989
Feb 21, 1986
MALLINCKRODT 500MG;5MG
SOLUTION;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
A087336 001 Jul 08, 1982
MALLINCKRODT INC
MIKART
NESHER PHARMS
TABLET;ORAL
CO-GESIC
500MG/15ML;10MG/15ML
500MG/15ML;5MG/15ML
500MG/15ML;5MG/15ML
500MG/15ML;7.5MG/15ML
A040508 001
A081226 001
A089557 001
A040366 001
Aug 29, 2003
Oct 27, 1992
Apr 29, 1992
Jan 23, 2002
UCB INC
DURADYNE DHC
500MG;5MG A087757 001 May 03, 1982
FOREST PHARMS
HY-PHEN
500MG;5MG A087809 001 Mar 17, 1983
ASCHER 500MG;5MG
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
A087677 001 May 03, 1982
ABLE
BARR
325MG;5MG
325MG;7.5MG
325MG;10MG
500MG;5MG
500MG;7.5MG
500MG;10MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
500MG;2.5MG
500MG;5MG
A040478 001
A040464 001
A040464 002
A040477 001
A040490 001
A040473 001
A040474 001
A040476 001
A040469 001
A040307 001
A040308 001
Nov 08, 2002
Oct 23, 2002
Oct 23, 2002
Nov 06, 2002
May 21, 2003
Nov 06, 2002
Jan 02, 2003
Oct 23, 2002
Oct 25, 2002
Jul 26, 2000
Jul 26, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-5( of 322)
ACETAMINOPHEN; HYDROCODONE BITARTRATE
TABLET;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
HALSEY
IVAX PHARMS
MIKART
MUTUAL PHARM
RANBAXY
RANBAXY LABS LTD
SANDOZ
UCB INC
USL PHARMA
VINTAGE PHARMS
VINTAGE PHARMS LLC
WATSON LABS
WATSON LABS FLORIDA
NORCET
500MG;5MG
500MG;7.5MG
500MG;10MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
500MG;5MG
500MG;5MG
500MG;2.5MG
500MG;5MG
500MG;5MG
650MG;5MG
500MG;5MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
500MG;5MG
500MG;10MG
325MG;10MG
750MG;7.5MG
500MG;5MG
750MG;7.5MG
500MG;10MG
650MG;7.5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;7.5MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
325MG;7.5MG
325MG;10MG
500MG;2.5MG
500MG;5MG
500MG;7.5MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
500MG;5MG
750MG;7.5MG
A088577 001
A040307 002
A040309 001
A040307 003
A040307 004
A040308 002
A089554 001
A089696 001
A089698 001
A089271 001
A089697 001
A040849 001
A040236 001
A040240 002
A040240 001
A040236 002
A040825 001
A040824 001
A040826 001
A040822 001
A040149 001
A040149 002
A040210 001
A040134 001
A089290 001
A089291 001
A089831 001
A040281 001
A040280 001
A040280 002
A040280 003
A040281 002
A040248 001
A040248 002
A040123 003
A040122 001
A040123 004
A040123 001
A040123 002
A040122 002
A040493 001
A040494 001
Dec 21, 1984
Jul 26, 2000
Jul 26, 2000
Jul 26, 2000
Jul 26, 2000
Jul 26, 2000
Jun 12, 1987
Apr 21, 1988
Aug 25, 1989
Jul 16, 1986
Jan 28, 1992
Jun 09, 2010
Sep 25, 1997
Nov 26, 1997
Nov 26, 1997
Sep 25, 1997
Aug 16, 2007
Aug 16, 2007
Aug 16, 2007
Aug 16, 2007
Jan 27, 1997
Jan 27, 1997
Aug 13, 1997
Nov 21, 1996
May 29, 1987
May 29, 1987
Sep 07, 1988
Sep 30, 1998
Sep 30, 1998
Sep 30, 1998
Sep 30, 1998
Sep 30, 1998
Apr 28, 2000
Apr 28, 2000
Mar 04, 1996
Mar 04, 1996
Mar 04, 1996
Mar 04, 1996
Mar 04, 1996
Mar 04, 1996
May 28, 2003
May 28, 2003
ABANA
TYCOLET
500MG;5MG A088871 001 May 15, 1986
ORTHO MCNEIL PHARM
VICODIN
500MG;5MG A089385 001 Aug 27, 1986
ABBOTT
ABBVIE
VICODIN ES
500MG;5MG
500MG;5MG
A085667 001
A088058 001 Jan 07, 1983
ABBVIE
VICODIN HP
750MG;7.5MG A089736 001 Dec 09, 1988
ABBVIE 660MG;10MG A040117 001 Sep 23, 1996
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
CAPSULE;ORAL
OXYCODONE AND ACETAMINOPHEN
ACTAVIS TOTOWA
BARR
HALSEY
MUTUAL PHARM
VINTAGE PHARMS LLC
TYLOX-325
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
A040199 001
A040304 001
A089994 001
A040219 001
A040303 001
Dec 30, 1998
Oct 02, 2000
May 04, 1989
Jan 22, 1998
Dec 30, 1999
ORTHO MCNEIL PHARM 325MG;5MG
SOLUTION;ORAL
OXYCODONE AND ACETAMINOPHEN
A088246 001 Nov 08, 1984
MALLINCKRODT INC 325MG/5ML;5MG/5ML A040680 001 Sep 29, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-6( of 322)
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
TABLET;ORAL
OXYCODONE 2.5/APAP 500
BRISTOL MYERS SQUIBB 500MG;2.5MG
OXYCODONE 5/APAP 500
BRISTOL MYERS SQUIBB 500MG;5MG
OXYCODONE AND ACETAMINOPHEN
A085910 001
A085911 001
ACTAVIS TOTOWA
BARR
DURAMED PHARMS BARR
MIKART
PERCOCET
325MG;5MG
325MG;5MG
325MG;5MG
400MG;2.5MG
A040203 001
A087406 001
A040272 001
A040679 001
Mar 15, 1999
Jun 30, 1998
May 16, 2006
VINTAGE PHARMS LLC
ROXICET 5/500
ROXANE
325MG;5MG
500MG;5MG
A085106 002
A089775 001 Jan 12, 1989
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
CAPSULE;ORAL
TYLOX
ORTHO MCNEIL PHARM 500MG;4.5MG;0.38MG A085375 001
ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
TALACEN
SANOFI AVENTIS US 650MG;EQ 25MG BASE N018458 001 Sep 23, 1982
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE
TABLET;ORAL
DARVOCET
AAIPHARMA LLC
DOLENE AP-65
325MG;32.5MG N016844 001
LEDERLE 650MG;65MG
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
A085100 001
MYLAN
SANDOZ
VINTAGE PHARMS
WATSON LABS
WYGESIC
325MG;32MG
650MG;65MG
650MG;65MG
650MG;65MG
650MG;65MG
A083689 001
A083978 001
A089959 001
A040507 001
A040139 001
Jul 18, 1989
Jul 30, 2003
Dec 16, 1996
CARACO 650MG;65MG A084999 001
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
TABLET;ORAL
DARVOCET A500
XANODYNE PHARM
DARVOCET-N 100
500MG;100MG A076429 001 Sep 10, 2003
XANODYNE PHARM
DARVOCET-N 50
650MG;100MG N017122 002
XANODYNE PHARM
PROPACET 100
325MG;50MG N017122 001
TEVA 650MG;100MG
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
A070107 001 Jun 12, 1985
ABLE
ACTAVIS ELIZABETH
CORNERSTONE
HALSEY
IVAX SUB TEVA PHARMS
MALLINCKRODT
MIRROR PHARMS
MUTUAL PHARM
MYLAN
MYLAN PHARMS INC
SANDOZ
SUPERPHARM
TEVA
VINTAGE PHARMS
650MG;100MG
650MG;100MG
325MG;100MG
500MG;100MG
325MG;50MG
650MG;100MG
650MG;100MG
650MG;100MG
650MG;100MG
325MG;50MG
650MG;100MG
650MG;100MG
650MG;100MG
650MG;100MG
650MG;100MG
650MG;100MG
650MG;100MG
650MG;100MG
650MG;100MG
650MG;100MG
325MG;50MG
650MG;100MG
A075838 001
A070910 001
A076743 001
A076750 001
A072105 001
A072106 001
A070146 001
A075738 001
A077821 001
A070115 001
A070116 001
A070615 001
A070771 001
A070775 001
A072195 001
A070145 001
A070443 001
A071319 001
A070732 001
A074119 001
A074843 002
A074843 001
Jul 11, 2001
Jan 02, 1987
May 07, 2004
Jun 28, 2004
May 13, 1988
May 13, 1988
Aug 02, 1985
Feb 02, 2001
Feb 11, 2008
Jun 12, 1985
Jun 12, 1985
Mar 21, 1986
Mar 21, 1986
Mar 21, 1986
Feb 16, 1988
Jun 12, 1985
Jan 23, 1986
Jan 06, 1987
Jan 03, 1986
Dec 19, 1994
Feb 15, 2001
Feb 12, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
TABLET;ORAL
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
WATSON LABS
WATSON LABS FLORIDA
WOCKHARDT LTD
ACETAZOLAMIDE
TABLET;ORAL
ACETAZOLAMIDE
ALRA
ASCOT
MUTUAL PHARM
VANGARD
WATSON LABS
DIAMOX
DURAMED PHARMS BARR
ACETAZOLAMIDE SODIUM
INJECTABLE;INJECTION
ACETAZOLAMIDE SODIUM
HOSPIRA
DIAMOX
TEVA WOMENS
ACETIC ACID, GLACIAL
SOLUTION/DROPS;OTIC
ACETASOL
ACTAVIS MID ATLANTIC
ACETIC ACID
KV PHARM
ORLEX
WARNER CHILCOTT
325MG;50MG
650MG;100MG
500MG;100MG
650MG;100MG
325MG;50MG
650MG;100MG
250MG
250MG
250MG
250MG
250MG
250MG
125MG
250MG
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
2%
2%
2%
ACETIC ACID, GLACIAL; ALUMINUM ACETATE
SOLUTION/DROPS;OTIC
BOROFAIR
PHARMAFAIR 2%;0.79%
DOMEBORO
BAYER PHARMS 2%;0.79%
ACETIC ACID, GLACIAL; DESONIDE
SOLUTION/DROPS;OTIC
TRIDESILON
BAYER PHARMS 2%;0.05%
ACETIC ACID, GLACIAL; HYDROCORTISONE
SOLUTION/DROPS;OTIC
ACETIC ACID W/ HYDROCORTISONE
KV PHARM 2%;1%
HYDROCORTISONE AND ACETIC ACID
BAUSCH AND LOMB 2%;1%
WOCKHARDT 2%;1%
ORLEX HC
WARNER CHILCOTT 2%;1%
ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE
SUSPENSION/DROPS;OTIC
NEO-CORT-DOME
BAYER PHARMS
ACETOHEXAMIDE
TABLET;ORAL
ACETOHEXAMIDE
BARR
USL PHARMA
DYMELOR
LILLY
2%;1%;EQ 0.35% BASE
250MG
500MG
250MG
500MG
250MG
500MG
6-7( of 322)
A070398 001 Dec 18, 1986
A070399 001 Dec 18, 1986
A077196 001 Jun 28, 2005
A076609 001 Nov 16, 2004
A077677 001 Mar 16, 2007
A077677 002 Mar 16, 2007
A083320 001
A087686 001 Oct 20, 1982
A089753 001 Jun 22, 1988
A087654 001 Feb 05, 1982
A084498 002
A088882 001 Oct 22, 1985
N008943 001
N008943 002
A040108 001 Oct 30, 1995
N009388 001 Dec 05, 1990
A087146 001
A085493 001
A086845 001
A088606 001 Aug 21, 1985
A084476 001
N017914 001
A085492 001
A040097 001 Oct 31, 1994
A040168 001 Aug 30, 1996
A086844 001
N050238 001
A070869 001 Feb 09, 1987
A070870 001 Feb 09, 1987
A070753 001 Nov 03, 1986
A070754 001 Nov 03, 1986
N013378 002
N013378 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-8( of 322)
ACETOPHENAZINE MALEATE
TABLET;ORAL
TINDAL
SCHERING 20MG N012254 002
ACETRIZOATE SODIUM
SOLUTION;INTRAUTERINE
SALPIX
ORTHO MCNEIL PHARM 53% N009008 001
ACETYLCHOLINE CHLORIDE
FOR SOLUTION;OPHTHALMIC
MIOCHOL
NOVARTIS 20MG/VIAL N016211 001
ACETYLCYSTEINE
SOLUTION;INHALATION, ORAL
ACETYLCYSTEINE
HOSPIRA 10% A071364 001 May 01, 1989
20% A071365 001 May 01, 1989
ROXANE 10% A072621 001 Sep 30, 1992
20% A072622 001 Sep 30, 1992
MUCOMYST
APOTHECON 10% N013601 002
20% N013601 001
MUCOSIL-10
DEY 10% A070575 001 Oct 14, 1986
MUCOSIL-20
DEY 20% A070576 001 Oct 14, 1986
ACETYLCYSTEINE; ISOPROTERENOL HYDROCHLORIDE
SOLUTION;INHALATION
MUCOMYST W/ ISOPROTERENOL
MEAD JOHNSON 10%;0.05% N017366 001
ACETYLDIGITOXIN
TABLET;ORAL
ACYLANID
NOVARTIS 0.1MG N009436 001
ACRISORCIN
CREAM;TOPICAL
AKRINOL
SCHERING 2MG/GM N012470 001
ACYCLOVIR
CAPSULE;ORAL
ACYCLOVIR
ACTAVIS ELIZABETH 200MG A074906 001 Aug 26, 1997
DAVA PHARMS INC 200MG A074872 001 Apr 22, 1997
HERITAGE PHARMS INC 200MG A074889 001 Oct 31, 1997
IVAX SUB TEVA PHARMS 200MG A074674 001 Apr 22, 1997
LEK PHARM 200MG A074750 001 Apr 22, 1997
MYLAN 200MG A074977 001 Apr 13, 1998
ROXANE 200MG A074570 002 Apr 22, 1997
TEVA 200MG A074828 001 Apr 22, 1997
TEVA PHARMS 200MG A074914 001 Nov 26, 1997
WATSON LABS 200MG A075101 001 Apr 15, 1998
TABLET;BUCCAL
SITAVIG
BIOALLIANCE PHARMA 50MG N203791 001 Apr 12, 2013
TABLET;ORAL
ACYCLOVIR
ACTAVIS ELIZABETH 400MG A074870 001 Jun 05, 1997
800MG A074870 002 Jun 05, 1997
DAVA PHARMS INC 400MG A074834 001 Apr 24, 1997
800MG A074834 002 Apr 24, 1997
HERITAGE PHARMS INC 400MG A074891 001 Oct 31, 1997
800MG A074891 002 Oct 31, 1997
IVAX SUB TEVA PHARMS 400MG A074836 001 Apr 22, 1997
800MG A074836 002 Apr 22, 1997
LEK PHARM 400MG A074658 001 Apr 22, 1997
800MG A074658 002 Apr 22, 1997
MYLAN 400MG A074976 001 Apr 13, 1998
800MG A074976 002 Apr 13, 1998
TEVA 200MG **Federal Register determination A074556 001 Apr 22, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-9( of 322)
ACYCLOVIR
TABLET;ORAL
ACYCLOVIR
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
TEVA PHARMS 400MG
800MG
A075021 001
A075021 002
Mar 18, 1998
Mar 18, 1998
ACYCLOVIR SODIUM
INJECTABLE;INJECTION
ACYCLOVIR
ABBVIE
ACYCLOVIR SODIUM
EQ 50MG BASE/ML A075114 001 Jul 26, 1999
APOTHECON
HOSPIRA
TEVA PARENTERAL
ZOVIRAX
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 25MG BASE/ML
EQ 50MG BASE/ML
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 50MG BASE/ML
EQ 500MG BASE/VIAL
A074897 002
A074897 001
A074663 002
A074758 002
A074720 001
A075065 001
A074663 001
A074758 001
A074969 002
A075627 001
A074969 001
Feb 27, 1998
Feb 27, 1998
Apr 22, 1997
Apr 22, 1997
Apr 22, 1997
Feb 25, 1999
Apr 22, 1997
Apr 22, 1997
Aug 26, 1997
Mar 28, 2001
Aug 26, 1997
GLAXOSMITHKLINE EQ 1GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
N018603 002
N018603 003
N018603 001
Jun 29, 1989
Aug 30, 1983
Oct 22, 1982
ADAPALENE
SOLUTION;TOPICAL
DIFFERIN
GALDERMA LABS LP 0.1% N020338 001 May 31, 1996
ADENOSINE
INJECTABLE;INJECTION
ADENOSINE
HIKMA MAPLE
TEVA PHARMS USA
3MG/ML
3MG/ML
3MG/ML
A076501 001
A076564 001
A078676 001
Jun 16, 2004
Jun 16, 2004
Jul 31, 2008
ALATROFLOXACIN MESYLATE
INJECTABLE;INJECTION
TROVAN PRESERVATIVE FREE
PFIZER EQ 200MG BASE/VIAL
EQ 300MG BASE/VIAL
N020760 001
N020760 002
Dec 18, 1997
Dec 18, 1997
ALBUMIN CHROMATED CR-51 SERUM
INJECTABLE;INJECTION
CHROMALBIN
ISO TEX 100uCi/VIAL
250uCi/VIAL
500uCi/VIAL
N017835 001
N017835 002
N017835 003
ALBUMIN IODINATED I-125 SERUM
INJECTABLE;INJECTION
RADIO-IODINATED (I 125) SERUM ALBUMIN (HUMAN)
BAYER PHARMS 2.5uCi/AMP
RADIOIODINATED SERUM ALBUMIN (HUMAN) IHSA I 125
MALLINCKRODT 6.67uCi/ML
10uCi/ML
100uCi/ML
N017846 001
N017844 003
N017844 001
N017844 002
ALBUMIN IODINATED I-131 SERUM
INJECTABLE;INJECTION
MEGATOPE
ISO TEX 2mCi/VIAL
5uCi/AMP
20uCi/AMP
N017837 003
N017837 004
N017837 005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-10( of 322)
ALBUTEROL
AEROSOL, METERED;INHALATION
ALBUTEROL
ARMSTRONG PHARMS
GENPHARM
IVAX SUB TEVA PHARMS
PLIVA
PROVENTIL
0.09MG/INH
0.09MG/INH
0.09MG/INH
0.09MG/INH
A072273 001
A073045 001
A073272 001
A074072 001
Aug 14, 1996
Aug 19, 1997
Dec 28, 1995
Aug 01, 1996
SCHERING
VENTOLIN
0.09MG/INH N017559 001
GLAXOSMITHKLINE 0.09MG/INH N018473 001
ALBUTEROL SULFATE
CAPSULE;INHALATION
VENTOLIN ROTACAPS
GLAXOSMITHKLINE
SOLUTION;INHALATION
ALBUTEROL SULFATE
EQ 0.2MG BASE N019489 001 May 04, 1988
ACTAVIS MID ATLANTIC
APOTEX INC
BAUSCH AND LOMB
COPLEY PHARM
ROXANE
WOCKHARDT EU OPERATN
PROVENTIL
EQ 0.083% BASE
EQ 0.021% BASE
EQ 0.042% BASE
EQ 0.083% BASE
EQ 0.5% BASE
EQ 0.083% BASE
EQ 0.083% BASE
EQ 0.5% BASE
EQ 0.083% BASE
EQ 0.083% BASE
A073533 001
A078623 001
A078623 002
A075717 001
A076391 001
A075358 001
A073495 001
A073307 001
A075129 001
A075394 001
Sep 26, 1995
Apr 05, 2010
Apr 05, 2010
Feb 02, 2007
Apr 01, 2003
Mar 29, 2000
May 28, 1993
Nov 27, 1991
Feb 13, 2001
Nov 22, 1999
SCHERING
VENTOLIN
EQ 0.083% BASE
EQ 0.5% BASE
N019243 002
N019243 001
Jan 14, 1987
Jan 14, 1987
GLAXOSMITHKLINE
SYRUP;ORAL
ALBUTEROL SULFATE
EQ 0.083% BASE
EQ 0.5% BASE
N019773 001
N019269 002
Apr 23, 1992
Jan 16, 1987
ACTAVIS MID ATLANTIC
MOVA
WATSON LABS
PROVENTIL
EQ 2MG BASE/5ML
EQ 2MG BASE/5ML
EQ 2MG BASE/5ML
A075262 001
A074302 001
A073165 001
Mar 30, 1999
Sep 30, 1994
Apr 29, 1993
SCHERING
VENTOLIN
EQ 2MG BASE/5ML N018062 001 Jan 19, 1983
GLAXOSMITHKLINE
TABLET;ORAL
ALBUTEROL SULFATE
EQ 2MG BASE/5ML N019621 001 Jun 10, 1987
AM THERAP
COPLEY PHARM
DAVA PHARMS INC
PLIVA
SANDOZ
TEVA
UCB INC
WARNER CHILCOTT
WATSON LABS
PROVENTIL
EQ 2MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
A072449 001
A072450 001
A072966 001
A072967 001
A072859 001
A072860 001
A072316 001
A072317 001
A072151 001
A072152 001
A072619 001
A072779 001
A072938 001
A072620 001
A072780 001
A072939 001
A073120 001
A073121 001
A072817 001
A072818 001
A072629 001
A072630 001
A072765 001
Dec 05, 1989
Dec 05, 1989
Nov 22, 1991
Nov 22, 1991
Dec 20, 1989
Dec 20, 1989
Dec 05, 1989
Dec 05, 1989
Dec 05, 1989
Dec 05, 1989
Dec 05, 1989
Jun 25, 1993
Mar 30, 1990
Dec 05, 1989
Jun 25, 1993
Mar 30, 1990
Sep 29, 1992
Sep 29, 1992
Jan 09, 1990
Jan 09, 1990
Jan 31, 1991
Jan 31, 1991
Aug 28, 1991
SCHERING EQ 2MG BASE
EQ 4MG BASE
N017853 001
N017853 002
May 07, 1982
May 07, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-11( of 322)
ALBUTEROL SULFATE
TABLET;ORAL
VENTOLIN
GLAXOSMITHKLINE EQ 2MG BASE
EQ 4MG BASE
TABLET, EXTENDED RELEASE;ORAL
PROVENTIL
N019112 001
N019112 002
Jul 10, 1986
Jul 10, 1986
SCHERING
VOLMAX
EQ 4MG BASE N019383 001 Jul 13, 1987
MURO EQ 4MG BASE
EQ 8MG BASE
N019604 002
N019604 001
Dec 23, 1992
Dec 23, 1992
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
SOLUTION;INHALATION
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
APOTEX INC
SANDOZ INC
EQ 0.083% BASE;0.017%
EQ 0.083% BASE;0.017%
A077117 001
A076867 001
Dec 31, 2007
Dec 21, 2006
ALCOHOL
INJECTABLE;INJECTION
ALCOHOL 5% IN DEXTROSE 5%
MILES 5ML/100ML A083483 001
ALCOHOL; DEXTROSE
INJECTABLE;INJECTION
ALCOHOL 5% IN D5-W
HOSPIRA 5ML/100ML;5GM/100ML
ALCOHOL 5% IN DEXTROSE 5% IN WATER
A083263 001
BAXTER HLTHCARE 5ML/100ML;5GM/100ML A083256 001
ALENDRONATE SODIUM
TABLET;ORAL
ALENDRONATE SODIUM
MYLAN
SANDOZ
TEVA PHARMS
FOSAMAX
EQ 35MG BASE
EQ 70MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 35MG BASE
EQ 40MG BASE
EQ 70MG BASE
EQ 35MG BASE
EQ 70MG BASE
A078638 001
A078638 002
A075871 001
A075871 002
A075871 004
A075871 003
A075871 005
A076184 002
A076184 001
Aug 04, 2008
Aug 04, 2008
Apr 22, 2009
Apr 22, 2009
Apr 22, 2009
Apr 22, 2009
Apr 22, 2009
Aug 04, 2008
Feb 06, 2008
MERCK AND CO INC EQ 5MG BASE
EQ 10MG BASE
EQ 35MG BASE
EQ 40MG BASE
N020560 003
N020560 001
N020560 004
N020560 002
Apr 25, 1997
Sep 29, 1995
Oct 20, 2000
Sep 29, 1995
ALGLUCERASE
INJECTABLE;INJECTION
CEREDASE
GENZYME 10 UNITS/ML
80 UNITS/ML
N020057 004
N020057 003
May 08, 1992
Apr 05, 1991
ALKAVERVIR
TABLET;ORAL
VERILOID
3M 2MG N007336 002
3MG N007336 003
ALLOPURINOL
TABLET;ORAL
ALLOPURINOL
MUTUAL PHARM
PURACAP PHARM
PUREPAC PHARM
SANDOZ
SUPERPHARM
WATSON LABS
100MG
300MG
100MG
300MG
100MG
300MG
100MG
300MG
100MG
300MG
100MG
100MG
300MG
A070466 001
A070467 001
A070150 001
A070147 001
A070579 001
A070580 001
A070268 001
A070269 001
A070950 001
A070951 001
N018241 001
N018785 001
N018241 002
Dec 24, 1985
Dec 24, 1985
Dec 10, 1985
Dec 10, 1985
Apr 14, 1986
Apr 14, 1986
Dec 31, 1985
Dec 31, 1985
Nov 30, 1988
Nov 30, 1988
Nov 16, 1984
Sep 28, 1984
Nov 16, 1984
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-12( of 322)
ALLOPURINOL
TABLET;ORAL
ALLOPURINOL
LOPURIN
300MG N018785 002 Sep 28, 1984
ABBOTT 100MG N018297 001
300MG N018297 002
ALPRAZOLAM
SOLUTION;ORAL
ALPRAZOLAM
ROXANE
TABLET;ORAL
ALPRAZOLAM
0.5MG/5ML A074314 001 Oct 31, 1993
IVAX SUB TEVA PHARMS 0.25MG
0.5MG
1MG
2MG
ROXANE 0.25MG
0.5MG
1MG
TEVA 0.25MG
0.5MG
1MG
2MG
WATSON LABS 0.25MG
0.25MG
0.5MG
0.5MG
1MG
1MG
TABLET, EXTENDED RELEASE;ORAL
ALPRAZOLAM
A074294 001
A074294 002
A074294 003
A074294 004
A074199 001
A074199 002
A074199 003
A074085 001
A074085 002
A074085 003
A074085 004
A074456 001
A074479 001
A074456 002
A074479 002
A074456 003
A074479 003
Jul 29, 1994
Jul 29, 1994
Jul 29, 1994
Jul 29, 1994
Oct 19, 1993
Oct 19, 1993
Oct 19, 1993
Feb 16, 1994
Feb 16, 1994
Feb 16, 1994
Feb 26, 1996
Aug 31, 1995
Jan 21, 1997
Aug 31, 1995
Jan 21, 1997
Aug 31, 1995
Jan 21, 1997
SANDOZ INC
TEVA PHARMS USA
VINTAGE PHARMS
0.5MG
1MG
2MG
3MG
0.5MG
1MG
2MG
3MG
0.5MG
1MG
2MG
3MG
A077777 001
A077777 002
A077777 003
A077777 004
A077979 001
A077979 002
A077979 003
A077979 004
A078442 001
A078442 002
A078442 003
A078442 004
Jun 30, 2006
Jun 30, 2006
Jun 30, 2006
Jun 30, 2006
Feb 28, 2007
Feb 28, 2007
Feb 28, 2007
Feb 28, 2007
Oct 15, 2007
Oct 15, 2007
Oct 15, 2007
Oct 15, 2007
ALPROSTADIL
INJECTABLE;INJECTION
CAVERJECT
PFIZER
EDEX
0.005MG/ML
0.01MG/ML
0.02MG/ML
N020755 001
N020755 002
N020755 003
Oct 31, 1997
Oct 01, 1997
Oct 01, 1997
ACTIENT PHARMS 0.005MG/VIAL N020649 001 Jun 12, 1997
ALSEROXYLON
TABLET;ORAL
RAUTENSIN
NOVARTIS 2MG N009215 001
RAUWILOID
3M 2MG N008867 001
ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE
TABLET, CHEWABLE;ORAL
ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE
PENNEX
FOAMICON
80MG;20MG A089449 001 Nov 27, 1987
NOVARTIS 80MG;20MG A072687 001 Jun 28, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-13( of 322)
AMANTADINE HYDROCHLORIDE
CAPSULE;ORAL
AMANTADINE HYDROCHLORIDE
ACTAVIS TOTOWA
WATSON LABS
SYMADINE
100MG
100MG
A077659 001
A071382 001
Feb 23, 2006
Jan 21, 1987
SOLVAY
SYMMETREL
100MG A071000 001 Sep 04, 1986
ENDO PHARMS 100MG N016020 001
SYRUP;ORAL
AMANTADINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC
TEVA PHARMS
SYMMETREL
50MG/5ML
50MG/5ML
A072655 001
A073115 001
Oct 30, 1990
Aug 23, 1991
ENDO PHARMS
TABLET;ORAL
SYMMETREL
50MG/5ML N016023 002
ENDO PHARMS 100MG N018101 001
AMCINONIDE
CREAM;TOPICAL
CYCLOCORT
ASTELLAS 0.025% N018116 001
0.1% N018116 002
LOTION;TOPICAL
CYCLOCORT
ASTELLAS
OINTMENT;TOPICAL
CYCLOCORT
0.1% N019729 001 Jun 13, 1988
ASTELLAS 0.1% N018498 001
AMDINOCILLIN
INJECTABLE;INJECTION
COACTIN
ROCHE 1GM/VIAL
250MG/VIAL
500MG/VIAL
N050565 003
N050565 001
N050565 002
Dec 21, 1984
Dec 21, 1984
Dec 21, 1984
AMIFOSTINE
INJECTABLE;INJECTION
ETHYOL
MEDIMMUNE 375MG/VIAL N020221 002 Sep 10, 1999
AMIKACIN SULFATE
INJECTABLE;INJECTION
AMIKACIN SULFATE
ABBOTT EQ 250MG BASE/ML
EQ 250MG BASE/ML
ASTRAZENECA EQ 50MG BASE/ML
EQ 250MG BASE/ML
HIKMA MAPLE EQ 50MG BASE/ML
EQ 250MG BASE/ML
HOSPIRA EQ 50MG BASE/ML
EQ 50MG BASE/ML
EQ 62.5MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
TEVA PHARMS USA EQ 50MG BASE/ML
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
A063265 001
A063266 001
A063167 001
A063169 001
A063274 001
A063275 001
A063263 001
A063350 001
A063283 001
A063264 001
A063350 002
A064098 001
A064099 001
A064045 001
Nov 30, 1994
Oct 31, 1994
Dec 14, 1995
Dec 14, 1995
May 18, 1992
May 18, 1992
Nov 30, 1994
Jul 30, 1993
Oct 31, 1994
Nov 30, 1994
Jul 30, 1993
Jun 26, 1995
Jun 20, 1995
Sep 28, 1993
HOSPIRA
AMIKIN
EQ 500MG BASE/100ML A064146 001 Apr 02, 1997
APOTHECON EQ 50MG BASE/ML
EQ 50MG BASE/ML
EQ 50MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
A062311 001
A062562 001
N050495 001
A062311 002
A062562 002
N050495 002
Sep 20, 1984
Sep 20, 1984
APOTHECON EQ 5MG BASE/ML
EQ 10MG BASE/ML
N050618 002
N050618 001
Nov 30, 1987
Nov 30, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-14( of 322)
AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
SANDOZ
TEVA
WATSON LABS
HYDRO-RIDE
EQ 5MG ANHYDROUS;50MG
EQ 5MG ANHYDROUS;50MG
EQ 5MG ANHYDROUS;50MG
A073357 001
A070795 001
A073334 001
Nov 27, 1991
Apr 17, 1988
Jul 19, 1991
PAR PHARM
MODURETIC 5-50
EQ 5MG ANHYDROUS;50MG A070347 001 Dec 25, 1990
MERCK EQ 5MG ANHYDROUS;50MG N018201 001
AMINO ACIDS
INJECTABLE;INJECTION
AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE
HOSPIRA 5.2% (5.2GM/100ML)
AMINOSYN 3.5% IN PLASTIC CONTAINER
N018901 001 Apr 06, 1984
ABBOTT
AMINOSYN II 3.5%
3.5% (3.5GM/100ML)
3.5% (3.5GM/100ML)
N018804 001
N018875 001
May 15, 1984
Aug 08, 1984
HOSPIRA 3.5% (3.5GM/100ML)
AMINOSYN II 3.5% IN PLASTIC CONTAINER
N019438 001 Apr 03, 1986
ABBOTT
AMINOSYN II 5%
3.5% (3.5GM/100ML) N019491 001 Oct 10, 1986
HOSPIRA 5% (5GM/100ML)
AMINOSYN-HBC 7% IN PLASTIC CONTAINER
N019438 002 Apr 03, 1986
ABBOTT
BRANCHAMIN 4%
7% (7GM/100ML) N019400 001 Jul 23, 1986
BAXTER HLTHCARE
FREAMINE 8.5%
4% (4GM/100ML) N018678 001 Sep 28, 1984
B BRAUN
FREAMINE II 8.5%
8.5% (8.5GM/100ML) N016822 001
B BRAUN
NEOPHAM 6.4%
8.5% (8.5GM/100ML) N016822 002
HOSPIRA
NOVAMINE 11.4%
6.4% (6.4GM/100ML) N018792 001 Jan 17, 1984
HOSPIRA INC
NOVAMINE 15%
11.4% (11.4GM/100ML) N017957 003 Aug 09, 1982
HOSPIRA INC 15% (75GM/500ML)
NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER
N017957 004 Nov 28, 1986
BAXTER HLTHCARE
NOVAMINE 8.5%
15% (15GM/100ML) N020107 001 Feb 05, 1993
HOSPIRA INC 8.5% (8.5GM/100ML) N017957 002 Aug 09, 1982
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM
PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML N019714 001 Sep 12, 1988
;22.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML N019683 001 Nov 07, 1988
;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 4.25%;36.8MG/100ML;20GM/100ML;51MG/100M N019714 002 Sep 12, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC 4.25%;36.8MG/100ML;20GM/100ML;51MG/100M N019683 002 Nov 07, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 4.25%;36.8MG/100ML;25GM/100ML;51MG/100M N019714 004 Sep 12, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC 4.25%;36.8MG/100ML;25GM/100ML;51MG/100M N019683 003 Nov 07, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2 N019714 003 Sep 12, 1988
2.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2 N019683 004 Nov 07, 1988
2.4MG/100ML;261MG/100ML;205MG/100ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
AMINO ACIDS; DEXTROSE
INJECTABLE;INJECTION
AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 3.5%;25GM/100ML
AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 3.5%;5GM/100ML
AMINOSYN 4.25% W/ DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 4.25%;25GM/100ML
AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 3.5%;25GM/100ML
3.5%;25GM/100ML
HOSPIRA 3.5%;25GM/100ML
AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 3.5%;5GM/100ML
3.5%;5GM/100ML
HOSPIRA 3.5%;5GM/100ML
AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
ABBOTT 4.25%;10GM/100ML
HOSPIRA 4.25%;10GM/100ML
AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
ABBOTT 4.25%;20GM/100ML
HOSPIRA 4.25%;20GM/100ML
AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 4.25%;25GM/100ML
4.25%;25GM/100ML
HOSPIRA 4.25%;25GM/100ML
AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 5%;25GM/100ML
5%;25GM/100ML
HOSPIRA 5%;25GM/100ML
TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;10GM/100ML
TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;15GM/100ML
TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;20GM/100ML
TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;25GM/100ML
TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;5GM/100ML
TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;10GM/100ML
TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;15GM/100ML
TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;20GM/100ML
TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;25GM/100ML
TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;5GM/100ML
N019118 001
N019120 001
N019119 001
N019505 002
N019713 006
N019681 001
N019506 001
N019713 002
N019681 002
N019713 001
N019681 004
N019713 004
N019681 005
N019504 002
N019713 005
N019681 003
N019565 001
N019713 003
N019681 006
N019520 002
N019520 003
N019520 004
N019520 005
N019520 001
N019520 007
N019520 008
N019520 009
N019520 010
N019520 006
6-15( of 322)
Oct 11, 1984
Oct 11, 1984
Oct 11, 1984
Nov 07, 1986
Sep 09, 1988
Nov 01, 1988
Nov 07, 1986
Sep 09, 1988
Nov 01, 1988
Sep 09, 1988
Nov 01, 1988
Sep 09, 1988
Nov 01, 1988
Nov 07, 1986
Sep 09, 1988
Nov 01, 1988
Dec 17, 1986
Sep 09, 1988
Nov 01, 1988
Sep 23, 1988
Sep 23, 1988
Sep 23, 1988
Sep 23, 1988
Sep 23, 1988
Sep 23, 1988
Sep 23, 1988
Sep 23, 1988
Sep 23, 1988
Sep 23, 1988
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM
PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER
ABBOTT 4.25%;10GM/100ML;51MG/100ML;176.5MG/100 N019712 002 Sep 08, 1988
ML;22.4MG/100ML;104.5MG/100ML;205MG/100
ML
HOSPIRA INC 4.25%;10GM/100ML;51MG/100ML;176.5MG/100 N019682 003 Nov 01, 1988
ML;22.4MG/100ML;104.5MG/100ML;205MG/100
ML
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC;
SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML N019564 002
;261MG/100ML;205MG/100ML
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 4.25%;25GM/100ML;51MG/100ML;22.4MG/100M N019564 004
L;261MG/100ML;205MG/100ML
Dec 16, 1986
Dec 16, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-16( of 322)
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE,
DIBASIC, HEPTAHYDRATE
INJECTABLE;INJECTION
AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12
0MG/100ML;49.3MG/100ML
3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12
0MG/100ML;49.3MG/100ML
HOSPIRA INC 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12
0MG/100ML;49.3MG/100ML
AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER
ABBOTT 4.25%;10GM/100ML;30MG/100ML;97MG/100ML;
120MG/100ML;49.3MG/100ML
HOSPIRA INC 4.25%;5GM/100ML;30MG/100ML;97MG/100ML;1
20MG/100ML;49.3MG/100ML
N019564 001 Dec 16, 1986
N019712 001 Sep 08, 1988
N019682 001 Nov 01, 1988
N019564 003 Dec 16, 1986
N019682 002 Nov 01, 1988
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM
CHLORIDE
INJECTABLE;INJECTION
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;10GM/100ML;51MG/100ML;261MG/100ML N020147 002
;216MG/100ML;112MG/100ML
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;15GM/100ML;51MG/100ML;261MG/100ML N020147 003
;216MG/100ML;112MG/100ML
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;20GM/100ML;51MG/100ML;261MG/100ML N020147 004
;216MG/100ML;112MG/100ML
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;25GM/100ML;51MG/100ML;261MG/100ML N020147 005
;216MG/100ML;112MG/100ML
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;5GM/100ML;51MG/100ML;261MG/100ML; N020147 001
216MG/100ML;112MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;10GM/100ML;51MG/100ML;261MG/100ML N020147 007
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;15GM/100ML;51MG/100ML;261MG/100ML N020147 008
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;20GM/100ML;51MG/100ML;261MG/100ML N020147 009
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;25GM/100ML;51MG/100ML;261MG/100ML N020147 010
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;5GM/100ML;51MG/100ML;261MG/100ML; N020147 006
297MG/100ML;77MG/100ML
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN 3.5% M IN PLASTIC CONTAINER
ABBOTT 3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N018804 002
234MG/100ML
3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N018875 002
234MG/100ML
AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN 3.5% M
HOSPIRA 3.5%;21MG/100ML;128MG/100ML;234MG/100ML N017789 005
Oct 23, 1995
Oct 23, 1995
Oct 23, 1995
Oct 23, 1995
Oct 23, 1995
Oct 23, 1995
Oct 23, 1995
Oct 23, 1995
Oct 23, 1995
Oct 23, 1995
May 15, 1984
Aug 08, 1984
AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC,
HEPTAHYDRATE
INJECTABLE;INJECTION
AMINOSYN II 3.5% M IN PLASTIC CONTAINER
ABBOTT 3.5%;32MG/100ML;128MG/100ML;222MG/100ML N019493 001 Oct 16, 1986
;49MG/100ML
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
INJECTABLE;INJECTION
VEINAMINE 8%
HOSPIRA INC 8%;61MG/100ML;211MG/100ML;56MG/100ML;38 N017957 001
8MG/100ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-17( of 322)
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN II 7% W/ ELECTROLYTES
HOSPIRA 7%;102MG/100ML;45MG/100ML;522MG/100ML;4 N019437 006 Apr 03, 1986
10MG/100ML
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC,
HEPTAHYDRATE
INJECTABLE;INJECTION
AMINOSYN II 3.5% M
HOSPIRA 3.5%;30MG/100ML;97MG/100ML;120MG/100ML;
49MG/100ML
N019437 007 Apr 03, 1986
AMINOCAPROIC ACID
INJECTABLE;INJECTION
AMICAR
CLOVER PHARMS
AMINOCAPROIC ACID
250MG/ML N015229 002
ABRAXIS PHARM
BAXTER HLTHCARE
HOSPIRA
250MG/ML
250MG/ML
250MG/ML
A070522 001
N018590 001
A070888 001
Jun 17, 1986
Oct 29, 1982
Jun 16, 1988
AMINOGLUTETHIMIDE
TABLET;ORAL
CYTADREN
NOVARTIS 250MG N018202 001
AMINOPHYLLINE
ENEMA;RECTAL
SOMOPHYLLIN
FISONS
INJECTABLE;INJECTION
AMINOPHYLLIN
300MG/5ML N018232 001 Apr 02, 1982
GD SEARLE LLC
AMINOPHYLLINE
25MG/ML
25MG/ML
A087243 001
A087621 001
May 24, 1982
May 24, 1982
ABRAXIS PHARM 25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
ELKINS SINN 25MG/ML
HOSPIRA 25MG/ML
INTL MEDICATION 25MG/ML
25MG/ML
25MG/ML
KING PHARMS 25MG/ML
LUITPOLD 25MG/ML
LYPHOMED 25MG/ML
PHARMA SERVE NY 25MG/ML
25MG/ML
SMITH AND NEPHEW 25MG/ML
25MG/ML
TEVA PARENTERAL 25MG/ML
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%
A084568 001
A087200 001
A087250 001
A087886 001
A088407 001
A087239 001
A087601 001
A087209 001
A087867 001
A087868 001
A086606 001
A087240 001
A087431 001
A087387 001
A087392 001
A088429 001
A088749 001
A081142 001
Jan 06, 1982
Aug 30, 1983
Jan 25, 1984
Jul 23, 1982
Feb 01, 1982
Nov 10, 1983
Nov 10, 1983
Jun 03, 1983
Dec 15, 1983
May 30, 1985
May 30, 1985
Sep 25, 1991
HOSPIRA 100MG/100ML
200MG/100ML
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
A088147 002
A088147 003
May 03, 1983
May 03, 1983
HOSPIRA
SOLUTION;ORAL
AMINOPHYLLINE
100MG/100ML
200MG/100ML
400MG/100ML
500MG/100ML
N018924 001
N018924 002
N018924 003
N018924 004
Dec 12, 1984
Dec 12, 1984
Dec 12, 1984
Dec 12, 1984
MORTON GROVE
ROXANE
AMINOPHYLLINE DYE FREE
105MG/5ML
105MG/5ML
A088156 001
A088126 001
Dec 05, 1983
Aug 19, 1983
ACTAVIS MID ATLANTIC
SOMOPHYLLIN
105MG/5ML A087727 001 Apr 16, 1982
FISONS
SOMOPHYLLIN-DF
105MG/5ML A086466 001
FISONS 105MG/5ML A087045 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-18( of 322)
AMINOPHYLLINE
SUPPOSITORY;RECTAL
TRUPHYLLINE
G AND W LABS
TABLET;ORAL
AMINOPHYLLIN
GD SEARLE LLC
AMINOPHYLLINE
ASCOT
BARR
DURAMED PHARMS BARR
HALSEY
HIKMA PHARMS LLC
IMPAX LABS
KV PHARM
LANNETT
PAL PAK
PANRAY
PUREPAC PHARM
ROXANE
SANDOZ
VALEANT PHARM INTL
VANGARD
VINTAGE PHARMS
WATSON LABS
TABLET, DELAYED RELEASE;ORAL
AMINOPHYLLINE
IMPAX LABS
TABLICAPS
VALE
TABLET, EXTENDED RELEASE;ORAL
PHYLLOCONTIN
PHARM RES ASSOC
AMINOSALICYLATE SODIUM
POWDER;ORAL
P.A.S. SODIUM
CENTURY PHARMS
SODIUM AMINOSALICYLATE
HEXCEL
TABLET;ORAL
PARASAL SODIUM
PANRAY
SODIUM P.A.S.
LANNETT
TEEBACIN
CONSOLIDATED MIDLAND
250MG
500MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
100MG
200MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
100MG
200MG
225MG
4GM/PACKET
100%
1GM
500MG
500MG
500MG
A085498 001 Mar 23, 1983
A085498 002 Jan 03, 1983
N002386 002
N002386 003
A087522 001 Feb 12, 1982
A087523 001 Feb 12, 1982
A088297 001 Aug 19, 1983
A088298 001 Aug 19, 1983
A088182 001 Mar 31, 1983
A088183 001 Mar 31, 1983
A084674 001
A084540 001
A085003 001
A084574 001
A084576 001
A085284 001
A085289 001
A084588 001
A084588 002
A084533 001
A084552 001
A084552 002
A084699 001
A085333 001
A087500 001 Feb 09, 1982
A087501 001 Feb 09, 1982
A085261 003
A085262 002
A085261 002
A084563 001
A088314 001 Oct 03, 1983
A088319 001 Oct 03, 1983
A085409 001
A085410 001
A085567 001
A085564 001
A084577 001
A084575 001
A084632 002
A084531 001
A084530 001
A086760 001
A080947 001
A080097 001
N006811 011
N006811 006
A080138 002
N007320 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-19( of 322)
AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID
TABLET;ORAL
NEOPASALATE
MEDPOINTE PHARM HLC 846MG;112MG A080059 002
AMINOSALICYLIC ACID
TABLET;ORAL
PARASAL
PANRAY 1GM N006811 002
500MG N006811 001
AMINOSALICYLIC ACID RESIN COMPLEX
POWDER;ORAL
REZIPAS
BRISTOL MYERS SQUIBB
AMIODARONE HYDROCHLORIDE
INJECTABLE;INJECTION
AMIODARONE HYDROCHLORIDE
BEDFORD
BEDFORD LABS
BEN VENUE
HOSPIRA
INTL MEDICATION SYS
JHP PHARMS LLC
TEVA PHARMS USA
CORDARONE
WYETH PHARMS INC
TABLET;ORAL
AMIODARONE HYDROCHLORIDE
TEVA
AMITRIPTYLINE HYDROCHLORIDE
CONCENTRATE;ORAL
ENDEP
ROCHE
INJECTABLE;INJECTION
AMITRIPTYLINE HYDROCHLORIDE
WATSON LABS
ELAVIL
ASTRAZENECA
TABLET;ORAL
AMITID
BRISTOL MYERS SQUIBB
AMITRIL
WARNER CHILCOTT
AMITRIPTYLINE HYDROCHLORIDE
AM THERAP
COPLEY PHARM
HALSEY
LEDERLE
EQ 500MG BASE/GM
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
200MG
40MG/ML
10MG/ML
10MG/ML
10MG
25MG
50MG
75MG
100MG
10MG
25MG
50MG
75MG
100MG
150MG
25MG
50MG
75MG
100MG
10MG
25MG
50MG
75MG
100MG
150MG
10MG
25MG
50MG
50MG
75MG
100MG
10MG
10MG
N009052 001
A076018 001 Oct 15, 2002
A076299 001 Oct 24, 2002
A076088 001 Oct 15, 2002
A076108 001 Oct 15, 2002
N021594 001 Feb 04, 2004
A076394 001 Apr 25, 2003
A076163 001 Sep 05, 2003
N020377 001 Aug 03, 1995
A074895 001 Apr 16, 1999
A085749 001
A085594 001
N012704 001
A086454 001
A086454 002
A086454 003
A086454 004
A086454 005
A083939 001
A083937 001
A083938 002
A084957 001
A085093 001
A086295 001
A088672 001 Nov 20, 1984
A088673 001 Nov 20, 1984
A088674 001 Nov 20, 1984
A088675 001 Nov 20, 1984
A088421 001 Apr 30, 1984
A088422 001 Apr 30, 1984
A088423 001 Apr 30, 1984
A088424 001 Apr 30, 1984
A088425 001 Apr 30, 1984
A088426 001 Apr 30, 1984
A085923 001
A085922 001
A085925 001
A087557 001 Mar 05, 1982
A085926 001 May 20, 1983
A085927 001 May 20, 1983
A086744 001
A087366 001 Jan 04, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
AMITRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
AMITRIPTYLINE HYDROCHLORIDE
25MG
25MG
50MG
50MG
75MG
75MG
100MG
100MG
150MG
MUTUAL PHARM 10MG
25MG
50MG
75MG
100MG
150MG
PAR PHARM 10MG
25MG
50MG
75MG
100MG
150MG
PLIVA 10MG
25MG
50MG
75MG
100MG
150MG
PUREPAC PHARM 10MG
10MG
25MG
25MG
50MG
50MG
75MG
75MG
100MG
100MG
ROXANE 10MG
10MG
25MG
25MG
50MG
50MG
75MG
75MG
100MG
100MG
150MG
150MG
SUPERPHARM 10MG
25MG
50MG
75MG
100MG
TEVA 10MG
10MG
25MG
25MG
50MG
50MG
75MG
75MG
100MG
100MG
150MG
UCB INC 10MG
25MG
50MG
75MG
6-20( of 322)
A086746 001
A087367 001 May 03, 1982
A086743 001
A087181 001 Jan 04, 1982
A086745 001
A087369 001 Jan 04, 1982
A086747 001
A087368 001 May 03, 1982
A087370 001 Jan 04, 1982
A085744 001
A085627 001
A085745 001
A085743 001
A085742 002 May 11, 1982
A089423 001 Feb 17, 1987
A088697 001 Sep 25, 1984
A088698 001 Sep 25, 1984
A088699 001 Sep 25, 1984
A088700 001 Sep 25, 1984
A088701 001 Sep 25, 1984
A088702 001 Sep 25, 1984
A088883 001 Sep 26, 1984
A088884 001 Sep 26, 1984
A088885 001 Sep 26, 1984
A088886 001 Sep 26, 1984
A088887 001 Sep 26, 1984
A088888 001 Sep 26, 1984
A088075 001 Sep 16, 1983
A088084 001 Jul 18, 1983
A088076 001 May 20, 1983
A088085 001 Jul 18, 1983
A088077 001 Sep 16, 1983
A088105 001 Jul 18, 1983
A088078 001 Sep 16, 1983
A088106 001 Jul 18, 1983
A088079 001 Sep 16, 1983
A088107 001 Jul 18, 1983
A086002 001
A086144 001
A085944 001
A086145 001
A085945 001
A086143 001
A086004 001
A086147 001
A086003 001
A086146 001
A086090 001
A086148 001
A088853 001 Nov 13, 1984
A088854 001 Nov 13, 1984
A088855 001 Nov 13, 1984
A088856 001 Nov 13, 1984
A088857 001 Nov 13, 1984
A084910 003
A086610 001
A085031 001
A086859 001
A085032 001
A086857 001
A085030 001
A086860 001
A085836 001
A086854 001
A086853 001
A085864 001
A085935 001
A085936 001
A086337 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
AMITRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
AMITRIPTYLINE HYDROCHLORIDE
USL PHARMA
VANGARD
WATSON LABS
WEST WARD
ELAVIL
ASTRAZENECA
ENDEP
ROCHE
100MG
150MG
25MG
10MG
50MG
75MG
100MG
10MG
10MG
25MG
25MG
50MG
50MG
75MG
75MG
100MG
100MG
150MG
150MG
10MG
25MG
10MG
25MG
50MG
75MG
100MG
150MG
10MG
25MG
50MG
75MG
100MG
150MG
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
TABLET;ORAL
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
MUTUAL PHARM EQ 12.5MG BASE;5MG
EQ 25MG BASE;10MG
PAR PHARM EQ 12.5MG BASE;5MG
EQ 25MG BASE;10MG
USL PHARMA EQ 12.5MG BASE;5MG
EQ 25MG BASE;10MG
WATSON LABS EQ 12.5MG BASE;5MG
EQ 25MG BASE;10MG
LIMBITROL
VALEANT PHARM INTL EQ 12.5MG BASE;5MG
LIMBITROL DS
VALEANT PHARM INTL EQ 25MG BASE;10MG
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
TABLET;ORAL
ETRAFON 2-10
SCHERING 10MG;2MG
ETRAFON 2-25
SCHERING 25MG;2MG
ETRAFON-A
SCHERING 10MG;4MG
ETRAFON-FORTE
SCHERING 25MG;4MG
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 10MG;2MG
10MG;4MG
25MG;2MG
25MG;4MG
50MG;4MG
MUTUAL PHARM 10MG;2MG
10MG;4MG
6-21( of 322)
A086336 001
A086335 001
A087775 001 Feb 10, 1982
A087632 001 Feb 01, 1982
A087616 001 Feb 08, 1982
A087617 001 Feb 05, 1982
A087639 001 Feb 08, 1982
A085816 001
A088620 001 Mar 02, 1984
A085817 001
A088621 001 Mar 02, 1984
A085815 001
A088622 001 Mar 02, 1984
A085819 001
A088633 001 Mar 02, 1984
A085820 001
A088634 001 Mar 02, 1984
A085821 001
A088635 001 Mar 02, 1984
A087647 001 Mar 05, 1982
A087278 001
N012703 001
N012703 003
N012703 004
N012703 005
N012703 006
N012703 007
A083639 001
A083639 002
A083639 003
A083639 004
A083639 005
A085303 001
A070765 001 Dec 10, 1986
A070766 001 Dec 10, 1986
A072277 001 May 09, 1988
A072278 001 May 09, 1988
A070477 001 Jan 12, 1988
A070478 001 Jan 12, 1988
A072052 001 Dec 16, 1988
A072053 001 Dec 16, 1988
N016949 001
N016949 002
N014713 007
N014713 004
N014713 002
N014713 006
A070935 001 Sep 11, 1986
A070937 001 Sep 11, 1986
A070936 001 Sep 11, 1986
A070938 001 Sep 11, 1986
A070939 001 Sep 12, 1986
A071077 001 Nov 12, 1986
A071078 001 Nov 12, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-22( of 322)
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
TABLET;ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
PAR PHARM
SANDOZ
WATSON LABS
TRIAVIL 2-10
25MG;2MG
25MG;4MG
10MG;2MG
10MG;4MG
25MG;2MG
25MG;4MG
50MG;4MG
10MG;2MG
10MG;4MG
25MG;2MG
25MG;4MG
50MG;4MG
10MG;2MG
10MG;2MG
10MG;2MG
10MG;4MG
10MG;4MG
10MG;4MG
25MG;2MG
25MG;2MG
25MG;2MG
25MG;4MG
25MG;4MG
25MG;4MG
50MG;4MG
50MG;4MG
50MG;4MG
A070297 001
A071079 001
A070565 001
A070620 001
A070621 001
A070595 001
A070574 001
A071062 001
A071862 001
A071063 001
A071064 001
A071863 001
A070373 001
A072539 001
A073007 001
A070375 001
A072540 001
A073009 001
A070374 001
A072541 001
A073008 001
A070376 001
A072134 001
A073010 001
A070377 001
A071558 001
A072135 001
Nov 12, 1986
Nov 12, 1986
Sep 11, 1986
Sep 11, 1986
Sep 11, 1986
Sep 11, 1986
Sep 11, 1986
Nov 27, 1987
Dec 21, 1987
Nov 27, 1987
Nov 27, 1987
Dec 21, 1987
Aug 25, 1986
Feb 15, 1989
Oct 17, 1991
Aug 25, 1986
Feb 15, 1989
Oct 17, 1991
Aug 25, 1986
Feb 15, 1989
Oct 17, 1991
Aug 25, 1986
Feb 15, 1989
Oct 17, 1991
Nov 04, 1986
Mar 02, 1987
Feb 15, 1989
NEW RIVER
TRIAVIL 2-25
10MG;2MG N014715 004
NEW RIVER
TRIAVIL 4-10
25MG;2MG N014715 002
NEW RIVER
TRIAVIL 4-25
10MG;4MG N014715 003
NEW RIVER
TRIAVIL 4-50
25MG;4MG N014715 005
NEW RIVER 50MG;4MG N014715 006
AMLEXANOX
PASTE;DENTAL
APHTHASOL
ULURU
PATCH;TOPICAL
AMLEXANOX
5% N020511 001 Dec 17, 1996
ULURU 2MG N021727 001 Sep 29, 2004
AMLODIPINE BESYLATE
TABLET;ORAL
AMLODIPINE BESYLATE
GEDEON RICHTER USA EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
GENPHARM EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
MUTUAL PHARMA EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
SANDOZ EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
SYNTHON PHARMS EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
TABLET, ORALLY DISINTEGRATING;ORAL
AMLODIPINE BESYLATE
A077333 001
A077333 002
A077333 003
A077362 001
A077362 002
A077362 003
A078081 001
A078081 002
A078081 003
A076859 001
A076859 002
A076859 003
A077080 001
A077080 002
A077080 003
Jul 17, 2007
Jul 17, 2007
Jul 17, 2007
Jul 09, 2007
Jul 09, 2007
Jul 09, 2007
Jan 31, 2008
Jan 31, 2008
Jan 31, 2008
Sep 10, 2007
Sep 10, 2007
Sep 10, 2007
Jun 27, 2007
Jun 27, 2007
Jun 27, 2007
SYNTHON PHARMS EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
N022026 001
N022026 002
N022026 003
Sep 27, 2007
Sep 27, 2007
Sep 27, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
AMLODIPINE MALEATE
TABLET;ORAL
AMVAZ
DR REDDYS LABS INC 2.5MG
5MG
10MG
AMMONIUM CHLORIDE
INJECTABLE;INJECTION
AMMONIUM CHLORIDE
ABBOTT 5MEQ/ML
GD SEARLE LLC 3MEQ/ML
AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
MCGAW 900MG/100ML
AMMONIUM CHLORIDE 2.14%
B BRAUN 40MEQ/100ML
AMODIAQUINE HYDROCHLORIDE
TABLET;ORAL
CAMOQUIN HYDROCHLORIDE
PARKE DAVIS EQ 200MG BASE
AMOXAPINE
TABLET;ORAL
AMOXAPINE
SANDOZ 25MG
50MG
100MG
150MG
WATSON LABS 25MG
50MG
100MG
150MG
ASENDIN
LEDERLE 25MG
50MG
100MG
150MG
AMOXICILLIN
CAPSULE;ORAL
AMOXICILLIN
LABS ATRAL 250MG
500MG
MYLAN 250MG
500MG
TEVA 250MG
250MG
500MG
500MG
AMOXIL
GLAXOSMITHKLINE 250MG
500MG
TRIMOX
APOTHECON 250MG
250MG
250MG
250MG
500MG
500MG
500MG
500MG
UTIMOX
PARKE DAVIS 250MG
500MG
WYMOX
WYETH AYERST 250MG
500MG
FOR SUSPENSION;ORAL
AMOXICILLIN
AM ANTIBIOTICS 125MG/5ML
250MG/5ML
MYLAN 125MG/5ML
250MG/5ML
6-23( of 322)
N021435 001 Oct 31, 2003
N021435 002 Oct 31, 2003
N021435 003 Oct 31, 2003
A083130 001
A086205 001
N006580 001
A085734 001
N006441 001
A072943 001 Jun 28, 1991
A072944 001 Jun 28, 1991
A072878 001 Jun 28, 1991
A072879 001 Jun 28, 1991
A072418 001 May 11, 1989
A072419 001 May 11, 1989
A072420 001 May 11, 1989
A072421 001 May 11, 1989
N018021 001
N018021 002
N018021 003
N018021 004
A062528 001 Aug 07, 1985
A062528 002 Aug 07, 1985
A062067 001
A062067 002
A062853 001 Dec 22, 1987
A063030 001 Feb 28, 1989
A062854 001 Dec 22, 1987
A063031 001 Feb 28, 1989
N050459 001
N050459 002
A061885 001
A062098 001
A062152 001
A063099 001 Mar 20, 1992
A061885 002
A062098 002
A062152 002
A063099 002 Mar 20, 1992
A062107 001
A062107 002
A062120 001
A062120 002
A062059 001
A062059 002
A062090 001
A062090 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-24( of 322)
AMOXICILLIN
FOR SUSPENSION;ORAL
AMOXICILLIN
RANBAXY
TEVA
AMOXIL
200MG/5ML
400MG/5ML
125MG/5ML
250MG/5ML
A065113 001
A065113 002
A062946 001
A063001 001
Nov 29, 2002
Nov 29, 2002
Nov 01, 1988
Jan 06, 1989
GLAXOSMITHKLINE
LAROTID
50MG/ML
125MG/5ML
250MG/5ML
N050460 005
N050460 001
N050460 002
GLAXOSMITHKLINE
POLYMOX
50MG/ML N050460 006
APOTHECON
TRIMOX
125MG/5ML
125MG/5ML
250MG/5ML
250MG/5ML
A061851 001
A062323 001
A061851 002
A062323 002
APOTHECON
UTIMOX
50MG/ML
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML
A061886 001
A061886 002
A062099 001
A062154 001
A062885 001
A061886 003
A062099 002
A062154 002
A062885 002
Mar 08, 1988
Mar 08, 1988
PARKE DAVIS
WYMOX
125MG/5ML
250MG/5ML
A062127 001
A062127 002
WYETH AYERST
TABLET;ORAL
AMOXICILLIN
125MG/5ML
250MG/5ML
A062131 001
A062131 002
DAVA PHARMS INC
TABLET, CHEWABLE;ORAL
AMOXICILLIN
875MG A065344 001 Jan 15, 2009
APOTHECON
DAVA PHARMS INC
RANBAXY
TEVA
AMOXIL
125MG
250MG
125MG
250MG
200MG
400MG
125MG
250MG
A064131 001
A064131 002
A064139 001
A064139 002
A065060 001
A065060 002
A064031 001
A064031 002
May 06, 1996
May 06, 1996
Jan 29, 1996
Jan 29, 1996
Nov 29, 2000
Nov 29, 2000
Dec 19, 1996
Dec 19, 1996
DR REDDYS LABS INC
TABLET, FOR SUSPENSION;ORAL
AMOXICILLIN
200MG
400MG
N050761 001
N050761 002
Apr 15, 1999
Apr 15, 1999
AUROBINDO PHARMA LTD
DISPERMOX
200MG
400MG
A065324 001
A065324 002
Jan 17, 2007
Jan 17, 2007
RANBAXY LABS LTD 200MG
400MG
600MG
A065080 002
A065080 001
A065159 001
Aug 11, 2003
Aug 11, 2003
Dec 04, 2003
AMOXICILLIN; CLAVULANATE POTASSIUM
TABLET;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
APOTEX INC
RANBAXY LABS
250MG;EQ 125MG BASE
500MG;EQ 125MG BASE
875MG;EQ 125MG BASE
500MG;EQ 125MG BASE
A065333 001
A065333 002
A065317 003
A065109 001
Feb 24, 2009
Feb 24, 2009
Oct 20, 2008
Nov 04, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-25( of 322)
AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE
CAPSULE;ORAL
DELCOBESE
TEVA
TABLET;ORAL
DELCOBESE
TEVA
1.25MG;1.25MG;1.25MG;1.25MG **Federal
Register determination that product was
not discontinued or withdrawn for
A083564 001
safety or efficacy reasons**
2.5MG;2.5MG;2.5MG;2.5MG **Federal
Register determination that product was
not discontinued or withdrawn for
A083564 002
safety or efficacy reasons**
3.75MG;3.75MG;3.75MG;3.75MG **Federal
Register determination that product was
not discontinued or withdrawn for
A083564 003
safety or efficacy reasons**
5MG;5MG;5MG;5MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
A083564 004
1.25MG;1.25MG;1.25MG;1.25MG **Federal
Register determination that product was
not discontinued or withdrawn for
A083563 004
safety or efficacy reasons**
2.5MG;2.5MG;2.5MG;2.5MG **Federal
Register determination that product was
not discontinued or withdrawn for
A083563 003
safety or efficacy reasons**
3.75MG;3.75MG;3.75MG;3.75MG **Federal
Register determination that product was
not discontinued or withdrawn for
A083563 002
safety or efficacy reasons**
5MG;5MG;5MG;5MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
A083563 001
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
SULFATE
TABLET;ORAL
ADDERALL 10
TEVA WOMENS
ADDERALL 12.5
TEVA WOMENS
ADDERALL 15
TEVA WOMENS
ADDERALL 20
TEVA WOMENS
ADDERALL 30
TEVA WOMENS
ADDERALL 5
TEVA WOMENS
ADDERALL 7.5
TEVA WOMENS
2.5MG;2.5MG;2.5MG;2.5MG **Federal
Register determination that product was
not discontinued or withdrawn for
N011522 007 Feb 13, 1996
safety or efficacy reasons**
3.125MG;3.125MG;3.125MG;3.125MG
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
N011522 012 Aug 31, 2000
3.75MG;3.75MG;3.75MG;3.75MG **Federal
Register determination that product was
not discontinued or withdrawn for
N011522 013 Aug 31, 2000
safety or efficacy reasons**
5MG;5MG;5MG;5MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
N011522 008 Feb 13, 1996
7.5MG;7.5MG;7.5MG;7.5MG **Federal
Register determination that product was
not discontinued or withdrawn for
N011522 010 May 12, 1997
safety or efficacy reasons**
1.25MG;1.25MG;1.25MG;1.25MG **Federal
Register determination that product was
not discontinued or withdrawn for
N011522 009 May 12, 1997
safety or efficacy reasons**
1.875MG;1.875MG;1.875MG;1.875MG
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
N011522 011 Aug 31, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-26( of 322)
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
SULFATE
TABLET;ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
TEVA PHARMS 1.25MG;1.25MG;1.25MG;1.25MG
2.5MG;2.5MG;2.5MG;2.5MG
5MG;5MG;5MG;5MG
7.5MG;7.5MG;7.5MG;7.5MG
WATSON LABS 1.25MG;1.25MG;1.25MG;1.25MG
2.5MG;2.5MG;2.5MG;2.5MG
5MG;5MG;5MG;5MG
7.5MG;7.5MG;7.5MG;7.5MG
AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX
CAPSULE, EXTENDED RELEASE;ORAL
BIPHETAMINE 12.5
UCB INC
BIPHETAMINE 20
UCB INC
BIPHETAMINE 7.5
UCB INC
AMPHETAMINE SULFATE
TABLET;ORAL
AMPHETAMINE SULFATE
LANNETT
AMPHOTERICIN B
CREAM;TOPICAL
FUNGIZONE
APOTHECON
INJECTABLE;INJECTION
AMPHOTERICIN B
ABBOTT
ABRAXIS PHARM
TEVA PARENTERAL
FUNGIZONE
APOTHECON
LOTION;TOPICAL
FUNGIZONE
APOTHECON
OINTMENT;TOPICAL
FUNGIZONE
APOTHECON
SUSPENSION;ORAL
FUNGIZONE
BRISTOL MYERS SQUIBB
AMPICILLIN SODIUM
INJECTABLE;INJECTION
AMPICILLIN SODIUM
ANTIBIOTICE
APOTHECON
CONSOLIDATED PHARM
HANFORD GC
HIKMA MAPLE
EQ 6.25MG BASE;EQ 6.25MG BASE
EQ 10MG BASE;EQ 10MG BASE
EQ 3.75MG BASE;EQ 3.75MG BASE
5MG
10MG
3%
50MG/VIAL
50MG/VIAL
50MG/VIAL
50MG/VIAL
3%
3%
100MG/ML
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
A040472 001 Sep 30, 2003
A040472 002 Sep 30, 2003
A040472 003 Sep 30, 2003
A040472 004 Sep 30, 2003
A040456 001 May 06, 2003
A040456 002 May 06, 2003
A040456 003 May 06, 2003
A040456 004 May 06, 2003
N010093 007
N010093 003
N010093 009
A083901 001 Aug 31, 1984
A083901 002 Aug 31, 1984
N050314 001
A064141 001 Dec 23, 1996
A062728 001 Apr 13, 1987
A064062 001 Mar 31, 1995
A060517 001
A060570 001
N050313 001
N050341 003
A090354 003 Dec 28, 2009
A090354 004 Dec 28, 2009
A090354 001 Dec 28, 2009
A090354 002 Dec 28, 2009
A062860 004 Feb 05, 1988
A062860 005 Feb 05, 1988
A062860 001 Feb 05, 1988
A062860 002 Feb 05, 1988
A062860 003 Feb 05, 1988
A061936 003
A061936 004
A061936 005
A061936 001
A061936 002
A063139 001 Apr 15, 1993
A063141 001 Apr 15, 1993
A063143 001 Apr 15, 1993
A063147 001 Apr 15, 1993
A062692 004 Jun 24, 1986
A062692 005 Jun 24, 1986
A062692 006 Jun 24, 1986
A062692 001 Jun 24, 1986
A062692 002 Jun 24, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
AMPICILLIN SODIUM
INJECTABLE;INJECTION
AMPICILLIN SODIUM
EQ 500MG BASE/VIAL
INTL MEDICATION EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
LILLY EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
MARSAM PHARMS LLC EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
OMNIPEN-N
WYETH AYERST EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
PENBRITIN-S
WYETH AYERST EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
POLYCILLIN-N
BRISTOL EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
TOTACILLIN-N
GLAXOSMITHKLINE EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
AMPICILLIN SODIUM; SULBACTAM SODIUM
INJECTABLE;INJECTION
UNASYN
PFIZER EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL
AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE;ORAL
AMCILL
PARKE DAVIS EQ 250MG BASE
EQ 500MG BASE
AMPICILLIN TRIHYDRATE
AM ANTIBIOTICS EQ 250MG BASE
EQ 500MG BASE
IVAX SUB TEVA PHARMS EQ 250MG BASE
EQ 500MG BASE
LEDERLE EQ 250MG BASE
EQ 500MG BASE
MYLAN EQ 250MG BASE
EQ 500MG BASE
PUREPAC PHARM EQ 250MG BASE
EQ 500MG BASE
TEVA EQ 250MG BASE
EQ 500MG BASE
VITARINE EQ 250MG BASE
6-27( of 322)
A062692 003 Jun 24, 1986
A062634 002 Jan 09, 1987
A062634 003 Jan 09, 1987
A062565 002 Apr 04, 1985
A062565 003 Jun 24, 1986
A062565 001 Apr 04, 1985
A062816 004 Oct 24, 1988
A062816 005 Oct 24, 1988
A062994 001 Sep 15, 1988
A062816 001 Oct 24, 1988
A062816 002 Oct 24, 1988
A062816 003 Oct 24, 1988
A060626 004
A062718 004 Dec 16, 1986
A060626 005
A062718 005 Dec 16, 1986
A060626 001
A062718 001 Dec 16, 1986
A060626 002
A062718 002 Dec 16, 1986
A060626 003
A062718 003 Dec 16, 1986
N050072 004
N050072 005
N050072 006
N050072 001
N050072 002
N050072 003
N050309 004
N050309 005
N050309 001
N050309 002
N050309 003
A060677 004
A062727 001 Dec 19, 1986
A060677 005
A062727 002 Dec 19, 1986
A060677 006
A060677 001
A060677 002
A060677 003
N050608 003 Dec 31, 1986
A062041 001
A062041 002
A061602 001
A061602 002
A060765 001
A060765 002
A062208 001
A062208 002
A061755 001
A061755 002
A061853 001
A061853 002
A061502 001
A061502 002
A061387 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE;ORAL
AMPICILLIN TRIHYDRATE
EQ 500MG BASE
OMNIPEN (AMPICILLIN)
WYETH AYERST 250MG
500MG
PENBRITIN
WYETH AYERST EQ 250MG BASE
EQ 500MG BASE
PFIZERPEN-A
PFIZER EQ 250MG BASE
EQ 500MG BASE
POLYCILLIN
BRISTOL EQ 250MG BASE
EQ 500MG BASE
PRINCIPEN
APOTHECON EQ 250MG BASE
EQ 500MG BASE
BRISTOL MYERS SQUIBB EQ 250MG BASE
EQ 500MG BASE
PRINCIPEN '250'
APOTHECON EQ 250MG BASE
EQ 250MG BASE
PRINCIPEN '500'
APOTHECON EQ 500MG BASE
EQ 500MG BASE
TOTACILLIN
GLAXOSMITHKLINE EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
FOR SUSPENSION;ORAL
AMCILL
PARKE DAVIS EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
AMPICILLIN TRIHYDRATE
AM ANTIBIOTICS EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
MYLAN EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
PUREPAC PHARM EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
TEVA EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
OMNIPEN (AMPICILLIN)
WYETH AYERST 100MG/ML
125MG/5ML
250MG/5ML
500MG/5ML
PENBRITIN
WYETH AYERST EQ 100MG BASE/ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
PFIZERPEN-A
PFIZER EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
POLYCILLIN
APOTHECON EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
BRISTOL EQ 100MG BASE/ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
PRINCIPEN
APOTHECON EQ 100MG BASE/ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
PRINCIPEN '125'
APOTHECON EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
6-28( of 322)
A061387 003
A060624 001
A060624 002
A060908 001
A060908 002
A062050 001
A062050 002
N050310 001
N050310 002
A062888 001 Mar 04, 1988
A062888 002 Mar 04, 1988
A061392 001
A061392 002
A062157 002
N050056 001
A062157 001
N050056 002
A060060 001
A062212 001
A060060 002
A062212 002
A062030 001
A062030 002
A061601 001
A061601 002
A061829 002
A061829 001
A061980 001
A061980 002
A061370 001
A061370 002
A060625 001
A060625 002
A060625 003
A060625 004
N050019 001
N050019 002
N050019 003
A062049 001
A062049 002
A062297 001
A062297 002
N050308 004
N050308 001
N050308 002
N050308 003
A061394 001
A061394 002
A061394 003
A060127 002
A062151 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
AMPICILLIN/AMPICILLIN TRIHYDRATE
FOR SUSPENSION;ORAL
PRINCIPEN '250'
APOTHECON
TOTACILLIN
GLAXOSMITHKLINE
TABLET, CHEWABLE;ORAL
POLYCILLIN
BRISTOL
AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID
CAPSULE;ORAL
PRINCIPEN W/ PROBENECID
APOTHECON
FOR SUSPENSION;ORAL
POLYCILLIN-PRB
APOTHECON
BRISTOL
PROBAMPACIN
TEVA
AMPRENAVIR
CAPSULE;ORAL
AGENERASE
GLAXOSMITHKLINE
SOLUTION;ORAL
AGENERASE
GLAXOSMITHKLINE
ANAGRELIDE HYDROCHLORIDE
CAPSULE;ORAL
AGRYLIN
SHIRE LLC
ANAGRELIDE HYDROCHLORIDE
ROXANE
SANDOZ INC
WATSON LABS
ANASTROZOLE
TABLET;ORAL
ANASTROZOLE
IMPAX LABS INC
KUDCO IRELAND
SYNTHON PHARMS
ANILERIDINE HYDROCHLORIDE
TABLET;ORAL
LERITINE
MERCK
ANILERIDINE PHOSPHATE
INJECTABLE;INJECTION
LERITINE
MERCK
ANISINDIONE
TABLET;ORAL
MIRADON
SCHERING
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE
EQ 389MG BASE;111MG
EQ 389MG BASE;111MG
EQ 3.5GM BASE/BOT;1GM/BOT
EQ 3.5GM BASE/BOT;1GM/BOT
EQ 3.5GM BASE/BOT;1GM/BOT
50MG
150MG
15MG/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
1MG
1MG
1MG
EQ 25MG BASE
25MG/ML
50MG
A060127 001
A062151 002
A060666 001
A062223 001
A060666 002
A062223 002
N050093 001
A062150 001
N050488 001
A061898 001
N050457 001
A061741 001
N021007 001
N021007 002
N021039 001
N020333 002
A076489 001
A076489 002
A076683 001
A076683 002
A076417 001
A076417 002
A091242 001
A091331 001
A078322 001
N010585 002
N010520 003
N010909 003
6-29( of 322)
Apr 15, 1999
Apr 15, 1999
Apr 15, 1999
Mar 14, 1997
Apr 18, 2005
Apr 18, 2005
Apr 18, 2005
Apr 18, 2005
Apr 18, 2005
Apr 18, 2005
May 31, 2012
Jan 05, 2011
Jun 28, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ANISOTROPINE METHYLBROMIDE
TABLET;ORAL
ANISOTROPINE METHYLBROMIDE
WATSON LABS 50MG
VALPIN 50
ENDO PHARMS 50MG
ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
VASOCON-A
NOVARTIS
APOMORPHINE HYDROCHLORIDE
INJECTABLE;SUBCUTANEOUS
APOKYN
US WORLDMEDS
APROTININ
INJECTABLE;INJECTION
TRASYLOL
BAYER HLTHCARE
ARBUTAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
GENESA
GENSIA AUTOMEDICS
ARDEPARIN SODIUM
INJECTABLE;INJECTION
NORMIFLO
PHARMACIA AND UPJOHN
ARGATROBAN
SOLUTION;IV (INFUSION)
ARGATROBAN IN DEXTROSE
SANDOZ
ARIPIPRAZOLE
0.5%;0.05%
20MG/2ML (10MG/ML)
10,000KIU/ML
0.05MG/ML
5,000 UNITS/0.5ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
10,000 UNITS/0.5ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
125MG/125ML (1MG/ML)
TABLET, ORALLY DISINTEGRATING;ORAL
ABILIFY
OTSUKA
ARMODAFINIL
TABLET;ORAL
NUVIGIL
CEPHALON
20MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
30MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
100MG
200MG
6-30( of 322)
A086046 001
N013428 001
N018746 002 Jul 11, 1994
N021264 001 Apr 20, 2004
N020304 001 Dec 29, 1993
N020420 001 Sep 12, 1997
N020227 002 May 23, 1997
N020227 001 May 23, 1997
N201743 001 May 09, 2011
N021729 004 Jun 07, 2006
N021729 005 Jun 07, 2006
N021875 002 Mar 26, 2009
N021875 005 Mar 26, 2009
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A
PALMITATE; VITAMIN E
INJECTABLE;INJECTION
BEROCCA PN
ROCHE 50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML;
100
N006071 003 Oct 10, 1985
IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;
VITAMIN E
INJECTABLE;INJECTION
M.V.C. 9+3
ABRAXIS PHARM 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N018440 002 Aug 08, 1985
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-31( of 322)
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;
VITAMIN E
INJECTABLE;INJECTION
M.V.I.-12
HOSPIRA 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2
0
N008809 004 Aug 08, 1985
MVC PLUS
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
WATSON LABS 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2
0
N018439 002 Aug 08, 1985
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
INJECTABLE;INJECTION
M.V.I.-12
HOSPIRA 20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N008809 005 Apr 22, 2004
0
IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/M
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; VITAMIN E
INJECTABLE;INJECTION
M.V.I.-12 LYOPHILIZED
ASTRAZENECA 100MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M N018933 002 Aug 08, 1985
G/VIAL;5MCG/VIAL;0.4MG/VIAL;40MG/VIAL;4
MG/VIAL;3.6MG/VIAL;3MG/VIAL;1MG/VIAL;10
MG/VIAL
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID;
PHYTONADIONE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A PALMITATE; VITAMIN E
INJECTABLE;INJECTION
VITAPED
HOSPIRA N/A,80MG/VIAL;N/A,0.02MG/VIAL;N/A,0.001 N020176 001 Dec 29, 1993
MG/VIAL;400
IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VI
AL;N/A,5MG/VIAL;0.2MG/10ML,N/A;N/A,1MG/
VIAL;N/A,1.4MG/VIAL;N/A,1.2MG/VIAL;EQ
2,300 UNITS BASE/10ML,N/A;7 IU/10ML,N/A
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE;
SODIUM SULFATE
FOR SOLUTION;ORAL
MOVIPREP
NOVEL LABS INC 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
ASPIRIN
TABLET;ORAL
BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN
BAYER
TABLET, EXTENDED RELEASE;ORAL
8-HOUR BAYER
BAYER
MEASURIN
BAYER
ASPIRIN; BUTALBITAL
TABLET;ORAL
AXOTAL
SAVAGE LABS
ASPIRIN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
500MG
650MG
650MG
650MG;50MG
BUTALBITAL, ASPIRIN AND CAFFEINE
MUTUAL PHARM 325MG;50MG;40MG
WATSON LABS 325MG;50MG;40MG
TABLET;ORAL
BUTALBITAL, ASPIRIN AND CAFFEINE
ACTAVIS ELIZABETH
HALSEY
IVAX PHARMS
PURACAP PHARM
QUANTUM PHARMICS
SANDOZ
WATSON LABS
FIORINAL
WATSON LABS INC
325MG;50MG;40MG
325MG;50MG;40MG
325MG;50MG;40MG
325MG;50MG;40MG
325MG;50MG;40MG
325MG;50MG;40MG
325MG;50MG;40MG
325MG;50MG;40MG
A090145 001 Jan 25, 2012
N021317 001 Oct 18, 2001
N016030 001
N016030 002
A088305 001 Oct 13, 1983
A078149 001 Jun 13, 2007
A086231 002 Feb 12, 1985
A086710 002 Aug 23, 1983
A089448 001 Dec 01, 1986
A085441 002 Oct 31, 1984
A087048 002 Dec 09, 1983
A088972 001 Jun 18, 1985
A086398 002 Apr 06, 1984
A086237 002 Mar 23, 1984
N017534 003 Apr 16, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-32( of 322)
ASPIRIN; BUTALBITAL; CAFFEINE
TABLET;ORAL
LANORINAL
LANNETT 325MG;50MG;40MG A086986 002 Oct 18, 1985
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE;ORAL
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
VINTAGE PHARMS LLC 325MG;50MG;40MG;30MG A075351 001 Mar 05, 1999
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
TABLET;ORAL
INVAGESIC
SANDOZ
INVAGESIC FORTE
385MG;30MG;25MG A074817 001 Nov 27, 1996
SANDOZ
ORPHENGESIC
770MG;60MG;50MG A074817 002 Nov 27, 1996
PRINSTON INC
ORPHENGESIC FORTE
385MG;30MG;25MG A075141 001 May 29, 1998
PRINSTON INC 770MG;60MG;50MG A075141 002 May 29, 1998
ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE
CAPSULE;ORAL
COMPOUND 65
ALRA
DARVON COMPOUND
389MG;32.4MG;65MG A084553 002 Aug 17, 1983
XANODYNE PHARM
DARVON COMPOUND-65
389MG;32.4MG;32MG N010996 006 Mar 08, 1983
XANODYNE PHARM
PROPOXYPHENE COMPOUND 65
389MG;32.4MG;65MG N010996 007 Mar 08, 1983
IVAX SUB TEVA PHARMS
SANDOZ
TEVA
PROPOXYPHENE COMPOUND-65
389MG;32.4MG;65MG
389MG;32.4MG;65MG
389MG;32.4MG;65MG
A083077 002
A080044 002
A089025 001
Dec 07, 1984
Sep 16, 1983
Mar 29, 1985
SANDOZ 389MG;32.4MG;65MG
PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE
WATSON LABS 389MG;32.4MG;65MG
A083101 002
A085732 002
Jun 24, 1985
Sep 03, 1984
ASPIRIN; CARISOPRODOL
TABLET;ORAL
CARISOPRODOL COMPOUND
WATSON LABS 325MG;200MG A088809 001 Oct 03, 1985
ASPIRIN; HYDROCODONE BITARTRATE
TABLET;ORAL
AZDONE
SCHWARZ PHARMA
VICOPRIN
500MG;5MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
A089420 001 Jan 25, 1988
ABBOTT 500MG;5MG A086333 001 Sep 14, 1983
ASPIRIN; MEPROBAMATE
TABLET;ORAL
EQUAGESIC
CARACO
MEPRO-ASPIRIN
325MG;200MG N011702 003 Dec 29, 1983
SANDOZ
MEPROBAMATE AND ASPIRIN
325MG;200MG A089127 001 Mar 02, 1987
PAR PHARM
MICRAININ
325MG;200MG A089126 001 Aug 19, 1986
MEDPOINTE PHARM HLC
Q-GESIC
QUANTUM PHARMICS
325MG;200MG
325MG;200MG
A084978 001
A088740 001 Jun 01, 1984
ASPIRIN; METHOCARBAMOL
TABLET;ORAL
METHOCARBAMOL AND ASPIRIN
IVAX SUB TEVA PHARMS
MCNEIL
PAR PHARM
ROBAXISAL
325MG;400MG
325MG;400MG
325MG;400MG
A087211 001
A089193 001
A089657 001
Dec 22, 1982
Feb 12, 1986
Nov 04, 1988
ROBINS AH 325MG;400MG N012281 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-33( of 322)
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
TABLET;ORAL
CODOXY
HALSEY
OXYCODONE AND ASPIRIN
325MG;4.5MG;0.38MG A087464 001 Jul 01, 1982
MUTUAL PHARM 325MG;4.5MG;0.38MG
325MG;4.5MG;0.38MG
OXYCODONE AND ASPIRIN (HALF-STRENGTH)
ROXANE 325MG;2.25MG;0.19MG
PERCODAN
A040260 001
A087794 001
A087742 001
Jul 17, 1998
May 26, 1982
Jun 04, 1982
ENDO PHARMS
PERCODAN-DEMI
325MG;4.5MG;0.38MG N007337 006
ENDO PHARMS
ROXIPRIN
325MG;2.25MG;0.19MG N007337 005
ROXANE 325MG;4.5MG;0.38MG A087743 001 Jun 04, 1982
ASPIRIN; PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
TALWIN COMPOUND
SANOFI AVENTIS US 325MG;EQ 12.5MG BASE N016891 001
ASPIRIN; PRAVASTATIN SODIUM
TABLET, TABLET;ORAL
PRAVIGARD PAC (COPACKAGED)
BRISTOL MYERS SQUIBB
TABLET, TABLET, TABLET;ORAL
PRAVIGARD PAC (COPACKAGED)
BRISTOL MYERS SQUIBB
325MG,N/A;N/A,80MG
81MG,N/A;N/A,20MG
81MG,N/A;N/A,40MG
81MG,N/A;N/A,80MG
325MG,N/A;N/A,20MG
325MG,N/A;N/A,40MG
N021387 006
N021387 001
N021387 002
N021387 003
N021387 004
N021387 005
Jun 24, 2003
Jun 24, 2003
Jun 24, 2003
Jun 24, 2003
Jun 24, 2003
Jun 24, 2003
ASPIRIN; PROPOXYPHENE HYDROCHLORIDE
CAPSULE;ORAL
DARVON W/ ASA
XANODYNE PHARM 325MG;65MG N010996 005
ASPIRIN; PROPOXYPHENE NAPSYLATE
CAPSULE;ORAL
DARVON-N W/ ASA
AAIPHARMA LLC
TABLET;ORAL
DARVON-N W/ ASA
AAIPHARMA LLC
325MG;100MG
325MG;100MG
N016829 001
N016863 001
ATENOLOL
INJECTABLE;INJECTION
TENORMIN
ASTRAZENECA
TABLET;ORAL
ATENOLOL
0.5MG/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
N019058 001 Sep 13, 1989
ABLE
APOTHECON
MYLAN
NOSTRUM LABS
PLIVA
SANDOZ
SCS
TEVA
25MG
50MG
100MG
50MG
100MG
25MG
50MG
100MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
50MG
100MG
50MG
100MG
A076907 001
A076907 002
A076907 003
A073317 001
A073318 001
A074126 003
A074126 001
A074126 002
A074127 001
A074127 002
A074101 001
A074101 002
A074101 003
A074265 001
A074265 002
A074265 003
A073676 001
A073676 002
A073315 001
A073316 001
Jul 30, 2004
Jul 30, 2004
Jul 30, 2004
Mar 20, 1992
Mar 20, 1992
Aug 26, 1998
Mar 23, 1994
Mar 23, 1994
Feb 21, 1995
Feb 21, 1995
Jul 17, 1997
Jul 17, 1997
Jul 17, 1997
Feb 28, 1994
Feb 28, 1994
Feb 28, 1994
Oct 30, 1992
Oct 30, 1992
May 28, 1993
May 28, 1993
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-34( of 322)
ATENOLOL
TABLET;ORAL
ATENOLOL
TEVA PHARMS
WATSON LABS
50MG
100MG
50MG
100MG
A074120 001
A074120 002
A073352 001
A073353 001
Feb 24, 1995
Feb 24, 1995
Dec 27, 1991
Dec 27, 1991
ATENOLOL; CHLORTHALIDONE
TABLET;ORAL
ATENOLOL AND CHLORTHALIDONE
NOSTRUM LABS
PLIVA
50MG;25MG
100MG;25MG
50MG;25MG
100MG;25MG
A074404 001
A074404 002
A074107 001
A074107 002
May 14, 1998
May 14, 1998
Sep 24, 1997
Sep 24, 1997
ATOMOXETINE HYDROCHLORIDE
CAPSULE;ORAL
ATOMOXETINE HYDROCHLORIDE
ZYDUS PHARMS USA INC
STRATTERA
18MG
25MG
40MG
60MG
80MG
100MG
A079017 001
A079017 002
A079017 003
A079017 004
A079017 005
A079017 006
Sep 17, 2010
Sep 17, 2010
Sep 17, 2010
Sep 17, 2010
Sep 17, 2010
Sep 17, 2010
LILLY 5MG N021411 001 Nov 26, 2002
ATORVASTATIN CALCIUM
TABLET;ORAL
ATORVASTATIN CALCIUM
TEVA PHARMS EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 80MG BASE
A078773 001
A078773 002
A078773 003
A078773 004
May 29, 2012
May 29, 2012
May 29, 2012
May 29, 2012
ATOVAQUONE
TABLET;ORAL
MEPRON
GLAXOSMITHKLINE LLC 250MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N020259 001 Nov 25, 1992
ATRACURIUM BESYLATE
INJECTABLE;INJECTION
ATRACURIUM BESYLATE
BAXTER HLTHCARE 10MG/ML
BAXTER HLTHCARE CORP 10MG/ML
HOSPIRA 10MG/ML
10MG/ML
MARSAM PHARMS LLC 10MG/ML
TEVA PARENTERAL 10MG/ML
ATRACURIUM BESYLATE PRESERVATIVE FREE
A074824 001
A074753 001
A074632 001
A074740 001
A074945 001
A074784 001
Sep 30, 1997
Jan 23, 1997
Dec 23, 1996
Mar 28, 1997
Jul 28, 1998
Jun 11, 1997
BAXTER HLTHCARE
BAXTER HLTHCARE CORP
HOSPIRA
MARSAM PHARMS LLC
TRACRIUM
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
A074825 001
A074768 001
A074633 001
A074639 001
A074741 001
A074944 001
Sep 30, 1997
Jan 23, 1997
Dec 23, 1996
Mar 25, 1997
Mar 28, 1997
Jul 28, 1998
HOSPIRA
TRACRIUM PRESERVATIVE FREE
10MG/ML N018831 002 Jun 20, 1985
HOSPIRA 10MG/ML N018831 001 Nov 23, 1983
ATROPINE
INJECTABLE;INJECTION
ATROPINE
ABBVIE EQ 2MG SULFATE/0.7ML A071295 001 Jan 30, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ATROPINE SULFATE
AEROSOL, METERED;INHALATION
ATROPINE SULFATE
US ARMY EQ 0.36MG BASE/INH
ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
TABLET;ORAL
MOTOFEN HALF-STRENGTH
VALEANT 0.025MG;0.5MG
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
CAPSULE;ORAL
DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE
SCHERER RP
SOLUTION;ORAL
COLONAID
MEDPOINTE PHARM HLC
LOMANATE
ALPHARMA US PHARMS
LOMOTIL
GD SEARLE LLC
TABLET;ORAL
COLONAID
MEDPOINTE PHARM HLC
DI-ATRO
MD PHARM
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ABLE
ASCOT
HEATHER
INWOOD LABS
IVAX PHARMS
KV PHARM
LEDERLE
MUTUAL PHARM
PARKE DAVIS
PVT FORM
R AND S PHARMA
ROXANE
SANDOZ
USL PHARMA
VALEANT PHARM INTL
WATSON LABS
WEST WARD
LO-TROL
VANGARD
LOGEN
SUPERPHARM
LOW-QUEL
HALSEY
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
0.025MG;2.5MG
ATROPINE SULFATE; EDROPHONIUM CHLORIDE
INJECTABLE;INJECTION
ENLON-PLUS
MYLAN INSTITUTIONAL 0.14MG/ML;10MG/ML
ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
ATROPINE AND DEMEROL
ABBVIE 0.4MG/ML;50MG/ML
0.4MG/ML;75MG/ML
0.4MG/ML;100MG/ML
MEPERIDINE AND ATROPINE SULFATE
WYETH AYERST 0.4MG/ML;50MG/ML
0.4MG/ML;75MG/ML
0.4MG/ML;100MG/ML
ATROPINE; PRALIDOXIME CHLORIDE
INJECTABLE;INTRAMUSCULAR
ATNAA
US ARMY 2.1MG/0.7ML;600MG/0.7ML;600MG/0.7ML
0.025MG;2.5MG
0.025MG/5ML;2.5MG/5ML
0.025MG/5ML;2.5MG/5ML
0.025MG/5ML;2.5MG/5ML
0.025MG;2.5MG
0.025MG;2.5MG
6-35( of 322)
N020056 001 Sep 19, 1990
N017744 001
A086440 001
A085735 001
A085746 001
N012699 001
A085737 001
A085266 001
A040395 001 Nov 27, 2000
A087934 001 Jul 19, 1983
A086798 001
A085509 001
A086727 001
A085659 001
A086950 001
A085506 001
A087131 001
A085766 001
A085035 001
A086057 001
A086173 001
A087842 001 Mar 29, 1982
A087195 001 Feb 16, 1982
A085876 001
A087765 001 Mar 15, 1982
A088009 001 Mar 25, 1983
A088962 001 May 10, 1985
A085211 001
N019677 001 Nov 06, 1991
A087853 001 Nov 26, 1982
A087847 001 Nov 26, 1982
A087848 001 Nov 26, 1982
A085121 001
A085121 002
A085121 003
N021175 001 Jan 17, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
AZATADINE MALEATE
TABLET;ORAL
OPTIMINE
SCHERING 1MG
AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
TRINALIN
SCHERING
AZATHIOPRINE
TABLET;ORAL
IMURAN
PROMETHEUS LABS
AZATHIOPRINE SODIUM
INJECTABLE;INJECTION
IMURAN
PROMETHEUS LABS
AZELASTINE HYDROCHLORIDE
SPRAY, METERED;NASAL
ASTEPRO
MEDA PHARMS
AZITHROMYCIN
CAPSULE;ORAL
ZITHROMAX
PFIZER
FOR SUSPENSION;ORAL
AZITHROMYCIN
SANDOZ
INJECTABLE;INJECTION
AZITHROMYCIN
PLIVA HRVATSKA DOO
TEVA PARENTERAL
1MG;120MG
25MG
EQ 100MG BASE/VIAL
EQ 0.125MG BASE/SPRAY
EQ 250MG BASE **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 100MG BASE/5ML
EQ 200MG BASE/5ML
EQ 500MG BASE/VIAL
EQ 2.5GM BASE/VIAL
EQ 500MG BASE/VIAL
AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE
FOR SUSPENSION, TABLET;ORAL
TROVAN/ZITHROMAX COMPLIANCE PAK
PFIZER
AZLOCILLIN SODIUM
INJECTABLE;INJECTION
AZLIN
BAYER PHARMS
AZTREONAM
INJECTABLE;INJECTION
AZACTAM
BRISTOL MYERS SQUIBB
AZACTAM IN PLASTIC CONTAINER
BRISTOL MYERS SQUIBB 10MG/ML
BACAMPICILLIN HYDROCHLORIDE
FOR SUSPENSION;ORAL
EQ 1GM BASE,N/A;N/A,EQ 100MG BASE
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 3GM BASE/VIAL
EQ 3GM BASE/VIAL
EQ 3GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 4GM BASE/VIAL
500MG/VIAL
SPECTROBID
PFIZER
TABLET;ORAL
SPECTROBID
PFIZER
125MG/5ML
400MG
800MG
N017601 001
N018506 001
N016324 002
N017391 001
N022203 001
N050670 001
A065297 001
A065297 002
A065265 001
N050809 002
N050809 001
N050762 001
A062388 001
A062417 001
N050562 001
A062388 002
A062417 002
N050562 002
A062388 003
A062417 003
N050562 003
N050580 001
N050632 003
N050556 001
N050520 001
N050520 002
6-36( of 322)
Mar 23, 1982
Oct 15, 2008
Nov 01, 1991
Sep 18, 2006
Sep 18, 2006
Jan 18, 2007
Dec 19, 2006
Dec 19, 2006
Dec 18, 1998
Sep 08, 1982
Oct 12, 1982
Sep 03, 1982
Sep 08, 1982
Oct 12, 1982
Sep 03, 1982
Sep 08, 1982
Oct 12, 1982
Sep 03, 1982
Dec 31, 1986
May 24, 1989
Mar 23, 1982
Sep 12, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
BACITRACIN
INJECTABLE;INJECTION
BACITRACIN
PFIZER
OINTMENT;OPHTHALMIC
BACIGUENT
PHARMACIA AND UPJOHN
BACITRACIN
LILLY
PHARMADERM
PHARMAFAIR
OINTMENT;TOPICAL
BACITRACIN
COMBE
NASKA
POWDER;FOR RX COMPOUNDING
BACI-RX
X GEN PHARMS
BACITRACIN
APOTHEKERNES
PADDOCK LLC
BACITRACIN ZINC
POWDER;FOR RX COMPOUNDING
ZIBA-RX
X GEN PHARMS
50,000 UNITS/VIAL
500 UNITS/GM
500 UNITS/GM
500 UNITS/GM
500 UNITS/GM
500 UNITS/GM
500 UNITS/GM
5,000,000 UNITS/BOT
5,000,000 UNITS/BOT
5,000,000 UNITS/BOT
500,000 UNITS/BOT
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
CORTISPORIN
CITRON PHARMA LLC 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000
UNITS/GM
ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE
PHARMAFAIR 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000
UNITS/GM
OINTMENT;TOPICAL
NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE
PHARMAFAIR 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000
UNITS/GM
BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;TOPICAL
LANABIOTIC
COMBE 400 UNITS/GM;40MG/GM;EQ 5MG
BASE/GM;5,000 UNITS/GM
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
PHARMAFAIR 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
UNITS/GM
BACITRACIN-NEOMYCIN-POLYMYXIN
PHARMADERM 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000
UNITS/GM
NEO-POLYCIN
DOW PHARM 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000
UNITS/GM
NEOSPORIN
CITRON PHARMA LLC 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
UNITS/GM
OINTMENT;TOPICAL
BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
NASKA 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000
UNITS/GM
BACITRACIN ZINC; POLYMYXIN B SULFATE
AEROSOL;TOPICAL
POLYSPORIN
GLAXOSMITHKLINE
OINTMENT;OPHTHALMIC
OCUMYCIN
PHARMAFAIR
POLYSPORIN
MONARCH PHARMS
10,000 UNITS/GM;2,000,000 UNITS/GM
500 UNITS/GM;10,000 UNITS/GM
500 UNITS/GM;10,000 UNITS/GM
A060282 001
A060734 001
A060687 001
A062158 001
A062453 001
A062799 001
A062857 001
A061580 001
A061699 001
A062456 001
A061737 001
N050416 002
A062389 001
A062381 001
A062499 001
A062386 001
A062167 001
A060647 001
N050417 001
A062833 001
N050167 002
A062430 001
A061229 001
6-37( of 322)
Mar 28, 1984
May 14, 1987
Nov 13, 1987
Jul 27, 1983
Jul 02, 1982
Sep 06, 1985
Jun 03, 1985
Sep 09, 1982
Nov 09, 1987
Mar 01, 1985
Apr 08, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-38( of 322)
BACITRACIN ZINC; POLYMYXIN B SULFATE
OINTMENT;TOPICAL
BACITRACIN ZINC-POLYMYXIN B SULFATE
NASKA 500 UNITS/GM;10,000 UNITS/GM A062849 001 Nov 13, 1987
BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
ALTANA 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 A060731 002
UNITS/GM
BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
MYCITRACIN
PHARMACIA AND UPJOHN 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000
UNITS/GM
A061048 001
BACITRACIN; POLYMYXIN B SULFATE
DISC;TOPICAL
LANABIOTIC
COMBE 500 UNITS/GM;5,000 UNITS/GM N050598 001 Sep 22, 1986
BACLOFEN
TABLET;ORAL
BACLOFEN
TEVA
USL PHARMA
WATSON LABS
LIORESAL
10MG
20MG
10MG
20MG
10MG
10MG
20MG
20MG
A073043 001
A073044 001
A071260 001
A071261 001
A073092 001
A074698 001
A073093 001
A074698 002
Feb 27, 1992
Feb 27, 1992
May 06, 1988
May 06, 1988
Jan 28, 1994
Aug 20, 1996
Jan 28, 1994
Aug 20, 1996
NOVARTIS 10MG N017851 001
20MG
TABLET, ORALLY DISINTEGRATING;ORAL
KEMSTRO
N017851 003 Jan 20, 1982
UCB INC 10MG
20MG
N021589 001
N021589 002
Oct 30, 2003
Oct 30, 2003
BECLOMETHASONE DIPROPIONATE
AEROSOL, METERED;INHALATION
BECLOVENT
GLAXOSMITHKLINE
VANCERIL
0.042MG/INH N018153 001
SCHERING
VANCERIL DOUBLE STRENGTH
0.042MG/INH N017573 001
SCHERING
AEROSOL, METERED;NASAL
BECONASE
0.084MG/INH N020486 001 Dec 24, 1996
GLAXOSMITHKLINE
VANCENASE
0.042MG/INH N018584 001
SCHERING 0.042MG/INH N018521 001
BECLOMETHASONE DIPROPIONATE MONOHYDRATE
SPRAY, METERED;NASAL
VANCENASE AQ
SCHERING EQ 0.042MG DIPROP/SPRAY
EQ 0.084MG DIPROP/SPRAY
N019589 001
N020469 001
Dec 23, 1987
Jun 26, 1996
BENAZEPRIL HYDROCHLORIDE
TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE
GENPHARM 5MG
10MG
20MG
40MG
A076476 001
A076476 002
A076476 003
A076476 004
Feb 11, 2004
Feb 11, 2004
Feb 11, 2004
Feb 11, 2004
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
MYLAN PHARMS INC 5MG;6.25MG
10MG;12.5MG
20MG;12.5MG
20MG;25MG
A076612 001
A076612 002
A076612 003
A076612 004
Feb 11, 2004
Feb 11, 2004
Feb 11, 2004
Feb 11, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
BENDROFLUMETHIAZIDE
TABLET;ORAL
NATURETIN-10
APOTHECON
NATURETIN-2.5
APOTHECON
NATURETIN-5
APOTHECON
BENOXINATE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
BENOXINATE HYDROCHLORIDE
SOLA BARNES HIND
BENTIROMIDE
SOLUTION;ORAL
CHYMEX
SAVAGE LABS
BENZONATATE
CAPSULE;ORAL
BENZONATATE
NESHER PHARMS
BENZPHETAMINE HYDROCHLORIDE
TABLET;ORAL
BENZPHETAMINE HYDROCHLORIDE
COREPHARMA
DIDREX
PHARMACIA AND UPJOHN
BENZQUINAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
EMETE-CON
PFIZER
SUPPOSITORY;RECTAL
EMETE-CON
ROERIG
BENZTHIAZIDE
TABLET;ORAL
AQUATAG
SOLVAY
BENZTHIAZIDE
PVT FORM
EXNA
AH ROBINS INC
FOVANE
PFIZER
URESE
PFIZER
BENZTROPINE MESYLATE
TABLET;ORAL
BENZTROPINE MESYLATE
LANNETT HOLDINGS INC
MUTUAL PHARM
PROSAM LABS
QUANTUM PHARMICS
USL PHARMA
COGENTIN
MERCK
10MG
2.5MG
5MG
0.4%
500MG/7.5ML
100MG
200MG
50MG
25MG
EQ 50MG BASE/VIAL
EQ 100MG BASE
25MG
50MG
50MG
50MG
50MG
25MG
0.5MG
1MG
2MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
6-39( of 322)
N012164 003
N012164 001
N012164 002
A084149 001
N018366 001 Dec 29, 1983
A040795 001 Oct 31, 2007
A040795 002 Oct 31, 2007
A040714 001 Oct 29, 2007
N012427 003
N016820 001
N016818 006
N016001 001
N016001 002
A083206 001
N012489 001
N012128 002
N012128 003
A088877 001 Apr 11, 1985
A088894 001 Apr 11, 1985
A088895 001 Apr 11, 1985
A081264 001 Jan 23, 1992
A081265 001 Jan 23, 1992
A040699 001 Feb 14, 2008
A040705 001 Feb 14, 2008
A040706 001 Feb 14, 2008
A088514 001 Jan 31, 1984
A088510 001 Jan 31, 1984
A088511 001 Jan 31, 1984
A089211 001 Jun 14, 1988
A089212 001 Jun 14, 1988
A089213 001 Jun 14, 1988
N009193 004
N009193 003
N009193 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
BENZYL BENZOATE
EMULSION;TOPICAL
BENZYL BENZOATE
LANNETT
BEPRIDIL HYDROCHLORIDE
TABLET;ORAL
BEPADIN
MEDPOINTE PHARM HLC
VASCOR
JOHNSON AND JOHNSON
BETA CAROTENE
CAPSULE;ORAL
SOLATENE
ROCHE
BETAMETHASONE
CREAM;TOPICAL
CELESTONE
SCHERING
SYRUP;ORAL
CELESTONE
MERCK SHARP DOHME
TABLET;ORAL
CELESTONE
SCHERING
BETAMETHASONE BENZOATE
CREAM;TOPICAL
UTICORT
PARKE DAVIS
GEL;TOPICAL
UTICORT
PARKE DAVIS
LOTION;TOPICAL
UTICORT
PARKE DAVIS
OINTMENT;TOPICAL
UTICORT
PARKE DAVIS
BETAMETHASONE DIPROPIONATE
CREAM;TOPICAL
ALPHATREX
SAVAGE LABS
BETAMETHASONE DIPROPIONATE
PERRIGO NEW YORK
PHARMADERM
TARO
TEVA
DIPROSONE
SCHERING
CREAM, AUGMENTED;TOPICAL
DIPROLENE
SCHERING
DISC;TOPICAL
DIPROSONE
SCHERING
GEL, AUGMENTED;TOPICAL
DIPROLENE
SCHERING
LOTION;TOPICAL
ALPHATREX
SAVAGE LABS
BETAMETHASONE DIPROPIONATE
ALPHARMA US PHARMS
PHARMADERM
TARO
50%
200MG
300MG
400MG
200MG
300MG
400MG
30MG
0.2%
0.6MG/5ML
0.6MG
0.025%
0.025%
0.025%
0.025%
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.1% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
6-40( of 322)
A084535 001
N019001 001 Dec 28, 1990
N019001 002 Dec 28, 1990
N019001 003 Dec 28, 1990
N019002 001 Dec 28, 1990
N019002 002 Dec 28, 1990
N019002 003 Dec 28, 1990
N017589 001
N014762 001
N014215 002
N012657 003
N016998 002
N017244 001
N017528 001
N018089 001
N019138 001 Jun 26, 1984
A072536 001 Jan 31, 1990
A074579 001 Nov 26, 1997
N019136 001 Jun 26, 1984
A071143 001 Jun 17, 1987
A071476 001 Aug 10, 1987
N017536 001
N019408 001 Jan 31, 1986
N017829 001
N019408 002 Nov 22, 1991
A070273 001 Aug 12, 1985
A071085 001 Feb 03, 1987
A070274 001 Aug 12, 1985
A072276 001 Aug 24, 1988
A074272 001 Sep 30, 1994
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-41( of 322)
BETAMETHASONE DIPROPIONATE
LOTION;TOPICAL
BETAMETHASONE DIPROPIONATE
TEVA PHARMS
DIPROSONE
EQ 0.05% BASE A071882 001 Jun 06, 1988
SCHERING
OINTMENT;TOPICAL
ALPHATREX
EQ 0.05% BASE N017781 001
SAVAGE LABS
BETAMETHASONE DIPROPIONATE
EQ 0.05% BASE N019143 001 Sep 04, 1984
PERRIGO NEW YORK
PHARMADERM
TEVA
DIPROSONE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
A072526 001
N019140 001
A071477 001
Jan 31, 1990
Sep 04, 1984
Aug 10, 1987
SCHERING EQ 0.05% BASE N017691 001
BETAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
BETAMETHASONE SODIUM PHOSPHATE
WATSON LABS
CELESTONE
EQ 3MG BASE/ML A085738 001
SCHERING EQ 3MG BASE/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
N017561 001
BETAMETHASONE VALERATE
CREAM;TOPICAL
BETADERM
ROACO
BETAMETHASONE VALERATE
EQ 0.1% BASE N018839 001 Jun 30, 1983
PERRIGO NEW YORK
PHARMADERM
PHARMAFAIR
TARO
BETATREX
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
A070053 001
N018860 002
A070485 001
A070062 001
Jun 10, 1986
Aug 31, 1983
May 29, 1987
May 14, 1985
SAVAGE LABS
VALISONE
EQ 0.1% BASE N018862 001 Aug 31, 1983
SCHERING
LOTION;TOPICAL
BETAMETHASONE VALERATE
EQ 0.01% BASE
EQ 0.1% BASE
N016322 002
N016322 001
PHARMADERM
PHARMAFAIR
TEVA PHARMS
BETATREX
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
N018870 001
A070484 001
A071883 001
Aug 31, 1983
May 29, 1987
Apr 22, 1988
SAVAGE LABS
VALISONE
EQ 0.1% BASE N018867 001 Aug 31, 1983
SCHERING
OINTMENT;TOPICAL
BETA-VAL
EQ 0.1% BASE N016932 001
TEVA
BETAMETHASONE VALERATE
EQ 0.1% BASE A070069 001 Dec 19, 1985
PERRIGO NEW YORK
PHARMADERM
PHARMAFAIR
BETATREX
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
A071478 001
N018864 001
A070486 001
Dec 23, 1987
Aug 31, 1983
May 29, 1987
SAVAGE LABS
VALISONE
EQ 0.1% BASE N018863 001 Aug 31, 1983
SCHERING EQ 0.1% BASE N016740 001
BETAXOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
BETAXOLOL HYDROCHLORIDE
APOTEX INC
TABLET;ORAL
KERLONE
EQ 0.5% BASE A075446 001 Sep 28, 2000
SANOFI AVENTIS US 10MG
20MG
N019507 001
N019507 002
Oct 27, 1989
Oct 27, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-42( of 322)
BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE
TABLET;ORAL
KERLEDEX
SANOFI AVENTIS US 5MG;12.5MG
10MG;12.5MG
N019807 001
N019807 002
Oct 30, 1992
Oct 30, 1992
BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE
SUSPENSION/DROPS;OPHTHALMIC
BETOPTIC PILO
ALCON EQ 0.25% BASE;1.75% N020619 001 Apr 17, 1997
BETAZOLE HYDROCHLORIDE
INJECTABLE;INJECTION
HISTALOG
LILLY 50MG/ML N009344 001
BETHANECHOL CHLORIDE
INJECTABLE;INJECTION
URECHOLINE
ODYSSEY PHARMS 5MG/ML **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N006536 001
TABLET;ORAL
BETHANECHOL CHLORIDE
ABLE
ACTAVIS TOTOWA
ASCOT
IVAX SUB TEVA PHARMS
5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG
10MG
25MG
25MG
A040492 001
A040483 001
A040485 001
A040509 001
A040552 001
A040553 001
A040554 001
A040551 001
A088288 001
A088289 001
A084689 001
Jul 27, 2004
Jul 27, 2004
Jul 27, 2004
Jul 27, 2004
Oct 28, 2004
Oct 28, 2004
Oct 28, 2004
Oct 28, 2004
Jun 08, 1983
Jun 08, 1983
LANNETT 5MG A084702 001
10MG A084712 001
25MG A084074 001
LANNETT HOLDINGS INC
SANDOZ
5MG
50MG
5MG
A040703 001
A040677 001
A084353 001
Mar 27, 2008
Mar 27, 2008
10MG A084378 001
10MG A084379 001
25MG A084383 001
25MG A084384 001
WATSON LABS 5MG A084402 001
5MG A085230 002
5MG A085841 001
10MG A084408 001
10MG A085228 001
10MG A085842 001
25MG A084441 001
25MG A085229 001
25MG A085839 001
50MG A087397 001
50MG A087444 001
MYOTONACHOL
GLENWOOD 5MG A084188 001
10MG A084188 003
25MG A084188 004
URECHOLINE
ODYSSEY PHARMS 5MG N006536 003
10MG N006536 002
25MG N006536 004
50MG N006536 005
BETHANIDINE SULFATE
TABLET;ORAL
TENATHAN
ROBINS AH 10MG N017675 001
25MG N017675 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-43( of 322)
BICALUTAMIDE
TABLET;ORAL
BICALUTAMIDE
KUDCO IRELAND
SYNTHON PHARMS
50MG
50MG
A077995 001
A077973 001
Jul 06, 2009
Jul 06, 2009
BIPERIDEN LACTATE
INJECTABLE;INJECTION
AKINETON
ABBVIE 5MG/ML N012418 002
BISOPROLOL FUMARATE
TABLET;ORAL
BISOPROLOL FUMARATE
MUTUAL PHARM 5MG
10MG
A075474 001
A075474 002
Oct 25, 2002
Oct 25, 2002
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ACTAVIS ELIZABETH
APOTHECON
IVAX SUB TEVA PHARMS
SANDOZ
TEVA
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
A075672 001
A075672 002
A075672 003
A075642 002
A075642 001
A075642 003
A075632 001
A075632 002
A075632 003
A075527 001
A075527 003
A075527 002
A075686 001
A075686 002
A075686 003
Sep 25, 2000
Sep 25, 2000
Sep 25, 2000
Dec 27, 2000
Dec 27, 2000
Dec 27, 2000
Sep 27, 2000
Sep 27, 2000
Sep 27, 2000
Sep 25, 2000
Sep 25, 2000
Sep 25, 2000
Jan 19, 2001
Jan 19, 2001
Jan 19, 2001
BITOLTEROL MESYLATE
AEROSOL, METERED;INHALATION
TORNALATE
SANOFI AVENTIS US
SOLUTION;INHALATION
TORNALATE
0.37MG/INH N018770 001 Dec 28, 1984
SANOFI AVENTIS US 0.2% N019548 001 Feb 19, 1992
BLEOMYCIN SULFATE
INJECTABLE;INJECTION
BLENOXANE
BRISTOL MYERS SQUIBB
BLEOMYCIN SULFATE
EQ 15 UNITS BASE/VIAL
EQ 30 UNITS BASE/VIAL
N050443 001
N050443 002 Sep 07, 1995
PHARMACHEMIE BV
TEVA PARENTERAL
EQ 15 UNITS BASE/VIAL
EQ 15 UNITS BASE/VIAL
EQ 30 UNITS BASE/VIAL
A065201 001
A064084 001
A064084 002
Dec 13, 2007
Jun 01, 1996
Jun 01, 1996
BRETYLIUM TOSYLATE
INJECTABLE;INJECTION
BRETYLIUM TOSYLATE
ABRAXIS PHARM 50MG/ML
100MG/ML
ASTRAZENECA 50MG/ML
50MG/ML
50MG/ML
HIKMA MAPLE 50MG/ML
50MG/ML
HOSPIRA 50MG/ML
50MG/ML
INTL MEDICATION 50MG/ML
LUITPOLD 50MG/ML
BRETYLIUM TOSYLATE IN DEXTROSE 5%
A070134 001
A071298 001
A071151 001
A071152 001
A071153 001
A070545 001
A070546 001
N019030 001
N019033 001
A070119 001
A070891 001
Apr 29, 1986
Feb 13, 1987
Aug 10, 1987
Aug 10, 1987
Aug 10, 1987
May 14, 1986
May 14, 1986
Apr 29, 1986
Apr 29, 1986
Apr 29, 1986
Jul 26, 1988
ABBOTT 200MG/100ML N019005 002 Apr 29, 1986
400MG/100ML N019005 003 Apr 29, 1986
800MG/100ML N019005 001 Apr 29, 1986
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 200MG/100ML N019837 002 Apr 12, 1989
400MG/100ML N019837 001 Apr 12, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
BRETYLIUM TOSYLATE
INJECTABLE;INJECTION
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA INC
BRETYLOL
HOSPIRA
BRIMONIDINE TARTRATE
SOLUTION/DROPS;OPHTHALMIC
ALPHAGAN
ALLERGAN
BRIMONIDINE TARTRATE
TEVA PARENTERAL
BROMFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC
XIBROM
ISTA PHARMS INC
BROMOCRIPTINE MESYLATE
CAPSULE;ORAL
BROMOCRIPTINE MESYLATE
LEK PHARM
200MG/100ML
400MG/100ML
800MG/100ML
50MG/ML
0.2%
0.5%
0.2%
EQ 0.09% ACID
EQ 5MG BASE
BROMODIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE;ORAL
AMBODRYL
PARKE DAVIS 25MG
BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE
SYRUP;ORAL
AMBENYL
FOREST LABS
BROMANYL
12.5MG/5ML;10MG/5ML
ALPHARMA US PHARMS 12.5MG/5ML;10MG/5ML
BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE
WOCKHARDT
BROMPHENIRAMINE MALEATE
ELIXIR;ORAL
BROMPHENIRAMINE MALEATE
ALPHARMA US PHARMS
KV PHARM
PHARM ASSOC
USL PHARMA
INJECTABLE;INJECTION
BROMPHENIRAMINE MALEATE
WATSON LABS
DIMETANE-TEN
WYETH AYERST
TABLET;ORAL
BROMPHENIRAMINE MALEATE
BARR
IVAX SUB TEVA PHARMS
NEWTRON PHARMS
NEXGEN PHARMA INC
PAR PHARM
PIONEER PHARMS
SANDOZ
VITARINE
WATSON LABS
DIMETANE
WYETH CONS
TABLET, EXTENDED RELEASE;ORAL
DIMETANE
WYETH CONS
12.5MG/5ML;10MG/5ML
2MG/5ML
2MG/5ML
2MG/5ML
2MG/5ML
10MG/ML
100MG/ML
10MG/ML
4MG
4MG
4MG
4MG
4MG
4MG
4MG
4MG
4MG
4MG
4MG
8MG
12MG
6-44( of 322)
N019008 002 Apr 29, 1986
N019008 003 Apr 29, 1986
N019008 001 Apr 29, 1986
N017954 001
N020613 001 Sep 06, 1996
N020490 001 Mar 13, 1997
A076372 001 Sep 10, 2004
N021664 001 Mar 24, 2005
A075100 001 Dec 10, 1998
N007984 001
N009319 006 Jan 10, 1984
A088343 001 Aug 15, 1984
A088626 001 Oct 12, 1984
A086936 001
A085466 001
A087517 001
A087964 001 Jan 25, 1983
A083821 001
A083820 001
N011418 002
A084468 001
A084351 001
A086987 001
A086187 001
A087009 001
A088604 001 Jul 13, 1984
A083215 001
A085850 001
A083123 001
A085769 001
N010799 003
N010799 010 Jun 10, 1983
N010799 011 Jun 10, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-45( of 322)
BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
SYRUP;ORAL
BROMANATE DC
ALPHARMA US PHARMS
DIMETANE-DC
ROBINS AH
MYPHETANE DC
WOCKHARDT
2MG/5ML;10MG/5ML;12.5MG/5ML A088723 001 Feb 25, 1985
2MG/5ML;10MG/5ML;12.5MG/5ML N011694 006 Mar 29, 1984
2MG/5ML;10MG/5ML;12.5MG/5ML A088904 001 Feb 21, 1985
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
SYRUP;ORAL
BROMANATE DM
ALPHARMA US PHARMS 2MG/5ML;10MG/5ML;30MG/5ML
BROMFED-DM
WOCKHARDT 2MG/5ML;10MG/5ML;30MG/5ML
DIMETANE-DX
ROBINS AH 2MG/5ML;10MG/5ML;30MG/5ML
BROMPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
ELIXIR;ORAL
BIPHETAP
MORTON GROVE
BROMANATE
ALPHARMA US PHARMS
DIMETAPP
WYETH CONS
TABLET, EXTENDED RELEASE;ORAL
BROMATAPP
COPLEY PHARM
DIMETAPP
WYETH CONS
4MG/5ML;25MG/5ML
4MG/5ML;25MG/5ML
2MG/5ML;12.5MG/5ML
12MG;75MG
12MG;75MG
BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE
ALZA
BUCLIZINE HYDROCHLORIDE
TABLET;ORAL
BUCLADIN-S
STUART PHARMS
BUDESONIDE
AEROSOL, METERED;NASAL
RHINOCORT
ASTRAZENECA
POWDER, METERED;INHALATION
PULMICORT
ASTRAZENECA
SPRAY, METERED;NASAL
RHINOCORT
ASTRAZENECA
SUSPENSION;INHALATION
BUDESONIDE
APOTEX INC
BUMETANIDE
INJECTABLE;INJECTION
BUMETANIDE
HOSPIRA
TEVA PARENTERAL
BUMEX
VALIDUS PHARMS INC
TABLET;ORAL
BUMEX
VALIDUS PHARMS INC
16MG;240MG
50MG
0.032MG/INH
0.16MG/INH
0.32MG/INH
0.064MG/INH
0.25MG/2ML
0.5MG/2ML
0.25MG/ML
0.25MG/ML
0.25MG/ML
0.5MG
1MG
2MG
A088722 001 Mar 07, 1985
A089681 001 Dec 22, 1988
N019279 001 Aug 24, 1984
A088687 001 Sep 26, 1984
A088688 001 Feb 06, 1985
N013087 003 Mar 29, 1984
A071099 001 Jul 02, 1987
N012436 003 May 14, 1985
N019672 001 Mar 29, 1996
N010911 006
N020233 001 Feb 14, 1994
N020441 002 Jun 24, 1997
N020441 003 Jun 24, 1997
N020746 002 Oct 01, 1999
A078202 001 Mar 30, 2009
A078202 002 Mar 30, 2009
A074160 001 Oct 30, 1997
A074613 001 Nov 18, 1997
N018226 001 Feb 28, 1983
N018225 002 Feb 28, 1983
N018225 001 Feb 28, 1983
N018225 003 Jun 14, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-46( of 322)
BUPIVACAINE
INJECTABLE, LIPOSOMAL;INJECTION
EXPAREL
PACIRA PHARMS INC 133MG/10ML (13.3MG/ML) N022496 001 Oct 28, 2011
BUPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE KIT
HOSPIRA 0.075%
0.114%
0.23%
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
N019978 001
N019978 002
N019978 003
Sep 03, 1992
Sep 03, 1992
Sep 03, 1992
INTL MEDICATED 0.25%
0.5%
0.75%
A076012 001
A076012 002
A076012 003
Jan 09, 2002
Jan 09, 2002
Jan 09, 2002
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
HOSPIRA 0.25%;0.005MG/ML
0.5%;0.005MG/ML
0.75%;0.005MG/ML
A071166 001
A071169 001
A071171 001
Jun 16, 1988
Jun 16, 1988
Jun 16, 1988
BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
DUOCAINE
AMPHASTAR PHARMS INC EQ 0.375% (37.5MG/10ML);EQ 1%
(100MG/10ML)
N021496 001 May 23, 2003
BUPRENORPHINE HYDROCHLORIDE
TABLET;SUBLINGUAL
SUBUTEX
RECKITT BENCKISER EQ 2MG BASE
EQ 8MG BASE
N020732 002
N020732 003
Oct 08, 2002
Oct 08, 2002
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
TABLET;SUBLINGUAL
SUBOXONE
RECKITT BENCKISER EQ 2MG BASE;EQ 0.5MG BASE **Federal
Register determination that product was
not discontinued or withdrawn for
N020733 001 Oct 08, 2002
safety or efficacy reasons**
EQ 8MG BASE;EQ 2MG BASE **Federal
Register determination that product was
not discontinued or withdrawn for
N020733 002 Oct 08, 2002
safety or efficacy reasons**
BUPROPION HYDROCHLORIDE
TABLET;ORAL
BUPROPION HYDROCHLORIDE
SANDOZ
TEVA
WELLBUTRIN
75MG
100MG
75MG
100MG
A075613 002
A075613 001
A075310 001
A075310 002
Oct 10, 2000
Oct 10, 2000
Nov 29, 1999
Nov 29, 1999
GLAXOSMITHKLINE 50MG
TABLET, EXTENDED RELEASE;ORAL
BUPROPION HYDROCHLORIDE
N018644 001 Dec 30, 1985
IMPAX LABS
SANDOZ
WELLBUTRIN SR
300MG
100MG
150MG
150MG
A077415 002
A076845 001
A076834 001
A076845 002
Dec 15, 2006
Jul 14, 2005
Jul 14, 2005
Jul 14, 2005
GLAXOSMITHKLINE
ZYBAN
50MG N020358 001 Oct 04, 1996
GLAXOSMITHKLINE 100MG N020711 002 May 14, 1997
BUSPIRONE HYDROCHLORIDE
CAPSULE;ORAL
BUSPAR
BRISTOL MYERS SQUIBB 5MG
7.5MG
10MG
15MG
N021190 001
N021190 002
N021190 003
N021190 004
Dec 20, 2000
Dec 20, 2000
Dec 20, 2000
Dec 20, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-47( of 322)
BUSPIRONE HYDROCHLORIDE
TABLET;ORAL
BUSPAR
BRISTOL MYERS SQUIBB
BUSPIRONE HYDROCHLORIDE
APOTEX
EGIS
IVAX SUB TEVA PHARMS
NESHER PHARMS
PROSAM LABS
SANDOZ
BUTABARBITAL SODIUM
CAPSULE;ORAL
BUTICAPS
MEDPOINTE PHARM HLC
ELIXIR;ORAL
BUTABARB
ALPHARMA US PHARMS
BUTABARBITAL SODIUM
WOCKHARDT
BUTALAN
LANNETT
SARISOL
HALSEY
TABLET;ORAL
BUTABARBITAL
BUNDY
BUTABARBITAL SODIUM
SANDOZ
SOLVAY
TEVA
WATSON LABS
WHITEWORTH TOWN PLSN
BUTISOL SODIUM
MEDA PHARMS
SARISOL NO. 1
HALSEY
SARISOL NO. 2
HALSEY
SODIUM BUTABARBITAL
IVAX SUB TEVA PHARMS
LANNETT
5MG
10MG
15MG
30MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG
15MG
30MG
50MG
100MG
30MG/5ML
30MG/5ML
33.3MG/5ML
30MG/5ML
30MG
15MG
15MG
30MG
30MG
16.2MG
32.4MG
48.6MG
97.2MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
100MG
15MG
30MG
15MG
30MG
15MG
30MG
N018731 001 Sep 29, 1986
N018731 002 Sep 29, 1986
N018731 003 Apr 22, 1996
N018731 004 Apr 22, 1996
A075521 001 Apr 05, 2002
A075521 002 Apr 05, 2002
A075521 003 Apr 05, 2002
A075119 001 Mar 14, 2002
A075119 002 Mar 14, 2002
A075119 003 Jan 23, 2003
A075385 001 Mar 01, 2002
A075385 002 Mar 01, 2002
A075385 003 Mar 01, 2002
A075572 001 Feb 27, 2002
A075572 002 Feb 27, 2002
A075572 003 Feb 27, 2002
A075388 001 May 09, 2002
A075388 002 May 09, 2002
A075388 003 May 09, 2002
A075413 001 Mar 19, 2002
A075413 002 Mar 19, 2002
A075413 003 Mar 19, 2002
A085381 001
A085381 002
A085381 003
A085381 004
A085873 001
A085383 001
A085880 001
A084723 001
A085550 001
A084292 003 Feb 09, 1982
A085938 001
A084272 002
A085934 001
A083606 001
A083898 001
A083897 001
A083896 001
A088632 001 May 18, 1985
A088631 001 May 01, 1985
A085764 001
A085772 001
A083325 002
A083337 001
N000793 002
N000793 005
A084719 001
A084719 002
A083484 001
A084040 001
A085849 001
A085866 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
BUTABARBITAL SODIUM
TABLET;ORAL
SODIUM BUTABARBITAL
MARSHALL PHARMA
WEST WARD
BUTOCONAZOLE NITRATE
CREAM;VAGINAL
FEMSTAT
ROCHE PALO
GYNAZOLE-1
KV PHARM
SUPPOSITORY;VAGINAL
FEMSTAT
ROCHE PALO
BUTORPHANOL TARTRATE
INJECTABLE;INJECTION
BUTORPHANOL TARTRATE
APOTEX INC
HOSPIRA
BUTORPHANOL TARTRATE PRESERVATIVE FREE
DISCONTINUED DRUG PRODUCT LIST
100MG
16.2MG
32.4MG
15MG
30MG
2%
2%
100MG
2MG/ML
1MG/ML
1MG/ML
2MG/ML
2MG/ML
APOTEX INC
HOSPIRA
STADOL
APOTHECON
STADOL PRESERVATIVE FREE
APOTHECON
SPRAY, METERED;NASAL
STADOL
BRISTOL MYERS SQUIBB
CABERGOLINE
TABLET;ORAL
DOSTINEX
PHARMACIA AND UPJOHN
CAFFEINE; ERGOTAMINE TARTRATE
SUPPOSITORY;RECTAL
CAFERGOT
NOVARTIS
TABLET;ORAL
CAFERGOT
NOVARTIS
WIGRAINE
ORGANON USA INC
CALCIFEDIOL
CAPSULE;ORAL
CALDEROL
ORGANON USA INC
CALCIPOTRIENE
OINTMENT;TOPICAL
DOVONEX
LEO PHARMA AS
CALCITONIN HUMAN
INJECTABLE;INJECTION
CIBACALCIN
NOVARTIS
1MG/ML
2MG/ML
1MG/ML
1MG/ML
2MG/ML
2MG/ML
2MG/ML
1MG/ML
2MG/ML
1MG/SPRAY
0.5MG
100MG;2MG
100MG;1MG
100MG;1MG
0.02MG
0.05MG
0.005%
0.5MG/VIAL
6-48( of 322)
A085881 001
A083524 001
A083858 001
A085418 001
A085432 001
N019215 001 Nov 25, 1985
N019881 001 Feb 07, 1997
N019359 001 Nov 25, 1985
A075697 001 Oct 23, 2001
A075342 001 Nov 04, 1999
A075559 001 Mar 20, 2000
A075342 002 Nov 04, 1999
A075559 002 Mar 20, 2000
A075695 001 Oct 23, 2001
A075695 002 Oct 23, 2001
A074620 001 Jan 22, 1997
A075170 001 Sep 28, 1998
A074620 002 Jan 22, 1997
A075170 002 Sep 28, 1998
N017857 004
N017857 001
N017857 002
N019890 001 Dec 12, 1991
N020664 001 Dec 23, 1996
N009000 002
N006620 001
A086562 001
N018312 001
N018312 002
N020273 001 Dec 29, 1993
N018470 001 Oct 31, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
CALCITONIN SALMON
INJECTABLE;INJECTION
CALCIMAR
SANOFI AVENTIS US
CALCITONIN-SALMON
ASTRAZENECA
MIACALCIN
NOVARTIS
CALCITRIOL
INJECTABLE;INJECTION
CALCITRIOL
HOSPIRA
TEVA PARENTERAL
CALCIUM ACETATE
CAPSULE;ORAL
PHOSLO
FRESENIUS MEDCL
TABLET;ORAL
CALCIUM ACETATE
ROXANE
PHOSLO
DISCONTINUED DRUG PRODUCT LIST
200 IU/ML
400 IU/VIAL
200 IU/ML
100 IU/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
EQ 84.5MG CALCIUM
EQ 169MG CALCIUM
EQ 169MG CALCIUM
FRESENIUS MEDCL EQ 169MG CALCIUM
CALCIUM CARBONATE; RISEDRONATE SODIUM
TABLET, TABLET;ORAL
ACTONEL WITH CALCIUM (COPACKAGED)
WARNER CHILCOTT EQ 500MG BASE,N/A;N/A,35MG **Federal
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
N017769 001
N017497 001
A073690 001
N017808 001
A075816 001
A075816 002
A075823 001
N021160 001
N021160 002
A077693 001
N019976 001
N021823 001
6-49( of 322)
Apr 14, 1995
Jul 03, 1986
Jan 16, 2004
Jan 16, 2004
Mar 31, 2003
Apr 02, 2001
Apr 02, 2001
Jan 30, 2008
Dec 10, 1990
Aug 12, 2005
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM
BICARBONATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
3.05GM/1000ML;0.157GM/1000ML;2.21GM/100
0ML;7.07GM/1000ML
PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0
5GM/1000ML;0.314GM/1000ML;3.09GM/1000ML
;6.46GM/1000ML
PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;
2.03GM/1000ML;0.314GM/1000ML;3.09GM/100
0ML;6.46GM/1000ML
PRISMASOL BK 0/0 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05
GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46
GM/1000ML
PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS 3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3
.05GM/1000ML;0.314GM/1000ML;3.09GM/1000
ML;6.46GM/1000ML
N021703 012 Oct 10, 2008
N021703 005 Oct 25, 2006
N021703 008 Oct 25, 2006
N021703 007 Oct 25, 2006
N021703 009 Oct 25, 2006
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE
INJECTABLE;INJECTION
ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 37MG/100ML;5GM/100ML;31MG/100ML;120MG/1 N018271 001
00ML;330MG/100ML;88MG/100ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE; SODIUM CITRATE
INJECTABLE;INJECTION
ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 35MG/100ML;5GM/100ML;30MG/100ML;74MG/10
0ML;640MG/100ML;500MG/100ML;74MG/100ML
N019867 001 Dec 20, 1993
ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 35MG/100ML;5GM/100ML;30MG/100ML;74MG/10
0ML;640MG/100ML;500MG/100ML;74MG/100ML
N018269 002 Jan 17, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
SOLUTION;INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN 29MG/100ML;2.5GM/100ML;15MG/100ML;610MG N018460 006
/100ML;560MG/100ML
DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
B BRAUN 29MG/100ML;1.5GM/100ML;15MG/100ML;610MG N018460 001
/100ML;560MG/100ML
DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
B BRAUN 29MG/100ML;4.25GM/100ML;15MG/100ML;610M N018460 003
G/100ML;560MG/100ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
SOLUTION;INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;1.5GM/100ML;15MG/100ML;560MG
/100ML;390MG/100ML
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;5GM/100ML;5MG/100ML;530MG/10
0ML;450MG/100ML
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;4.25GM/100ML;15MG/100ML;560M
G/100ML;390MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
FRESENIUS 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5
38MG/100ML;448MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
FRESENIUS 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5
38MG/100ML;448MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
FRESENIUS 18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;5
38MG/100ML;448MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
FRESENIUS 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;
538MG/100ML;448MG/100ML
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
B BRAUN 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1
00ML
6-50( of 322)
Jan 29, 1986
Jan 29, 1986
Jun 13, 1994
Jun 13, 1994
Jun 13, 1994
Jun 13, 1994
Feb 24, 1988
Oct 17, 1988
Oct 17, 1988
Oct 17, 1988
Oct 17, 1988
Oct 17, 1988
Mar 26, 1986
Mar 26, 1986
Mar 26, 1986
N018460 002
N018460 008
N018460 004
A020374 001
A020374 002
A020374 003
A020374 004
N018256 001
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN 4MG/100ML;4GM/100ML;6MG/100ML;120MG/100 N019634 002
ML;62MG/100ML
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N017510 001
00ML;310MG/100ML
MILES 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N018499 001
00ML;310MG/100ML
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;104MG/100ML;600MG/ N019685 005
100ML;310MG/100ML
20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019685 006
100ML;310MG/100ML
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019685 007
100ML;310MG/100ML
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019685 003
100ML;310MG/100ML
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;104MG/100ML;600MG/
100ML;310MG/100ML
CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE
SOLUTION;INTRAPERITONEAL
INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;538MG/100ML;44
8MG/100ML
INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;538MG/100ML;44
8MG/100ML
INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;538MG/100ML;4
48MG/100ML
N019685 001
N019395 001
N019395 002
N019395 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-51( of 322)
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
TPN ELECTROLYTES IN PLASTIC CONTAINER
ABBOTT 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML; N019399 001 Jun 16, 1986
16.1MG/ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
CITRATE
INJECTABLE;INJECTION
ISOLYTE E IN PLASTIC CONTAINER
B BRAUN 35MG/100ML;30MG/100ML;74MG/100ML;640MG/
100ML;500MG/100ML;74MG/100ML
N018899 001 Oct 31, 1983
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
ACETATED RINGER'S IN PLASTIC CONTAINER
B BRAUN 20MG/100ML;30MG/100ML;380MG/100ML;600MG
/100ML
N018725 001 Nov 29, 1982
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
RINGER'S IN PLASTIC CONTAINER
B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML
SOLUTION;IRRIGATION
RINGER'S IN PLASTIC CONTAINER
N018721 001 Nov 09, 1982
ABBOTT 33MG/100ML;30MG/100ML;860MG/100ML N018462 001
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
LACTATED RINGER'S IN PLASTIC CONTAINER
ABBOTT
B BRAUN
MILES
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML
N019485 001
N018023 001
N018417 001
Oct 24, 1985
CALCIUM GLUCEPTATE
INJECTABLE;INJECTION
CALCIUM GLUCEPTATE
ABBOTT
ABRAXIS PHARM
LILLY
EQ 90MG CALCIUM/5ML
EQ 90MG CALCIUM/5ML
EQ 90MG CALCIUM/5ML
EQ 90MG CALCIUM/5ML
A080001 001
A083159 001
A089373 001
N006470 001
Apr 30, 1987
CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM
INJECTABLE;INJECTION
ISOPAQUE 440
GE HEALTHCARE 0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML N016847 001
CALCIUM; MEGLUMINE; METRIZOIC ACID
INJECTABLE;INJECTION
ISOPAQUE 280
GE HEALTHCARE 0.35MG/ML;140.1MG/ML;461.8MG/ML N017506 001
CANDICIDIN
OINTMENT;VAGINAL
VANOBID
SANOFI AVENTIS US 0.6MG/GM A061596 001
TABLET;VAGINAL
VANOBID
SANOFI AVENTIS US 3MG A061613 001
CAPTOPRIL
TABLET;ORAL
CAPOTEN
PAR PHARM 37.5MG N018343 006 Sep 17, 1986
75MG N018343 007 Jun 13, 1995
150MG N018343 004 Jun 13, 1995
CAPTOPRIL
APOTHECON 12.5MG A074472 001 Mar 31, 1995
25MG A074472 002 Mar 31, 1995
50MG A074472 003 Mar 31, 1995
100MG A074472 004 Mar 31, 1995
CLONMEL HLTHCARE 12.5MG A074423 001 Feb 13, 1996
25MG A074423 002 Feb 13, 1996
50MG A074423 003 Feb 13, 1996
100MG A074423 004 Feb 13, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CAPTOPRIL
TABLET;ORAL
CAPTOPRIL
EGIS PHARMS
IVAX SUB TEVA PHARMS
PAR PHARM
PRINSTON INC
PUREPAC PHARM
SANDOZ
TEVA
TEVA PHARMS
VINTAGE PHARMS LLC
WATSON LABS
CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
12.5MG
25MG
25MG
50MG
50MG
100MG
100MG
12.5MG
12.5MG
25MG
25MG
50MG
50MG
100MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
IVAX SUB TEVA PHARMS 25MG;15MG
VINTAGE PHARMS LLC
WATSON LABS
CARBACHOL
SOLUTION;INTRAOCULAR
CARBACHOL
PHARMAFAIR
CARBASTAT
NOVARTIS
25MG;25MG
50MG;15MG
50MG;25MG
25MG;15MG
25MG;25MG
50MG;15MG
50MG;25MG
50MG;25MG
0.01%
0.01%
6-52( of 322)
A074748 004 May 29, 1997
A074748 002 May 29, 1997
A074748 001 May 29, 1997
A074748 003 May 29, 1997
A074590 004 Aug 30, 1996
A074590 002 Aug 30, 1996
A074590 001 Aug 30, 1996
A074590 003 Aug 30, 1996
A074493 001 Feb 13, 1996
A074493 002 Feb 13, 1996
A074493 003 Feb 13, 1996
A074493 004 Feb 13, 1996
A074477 001 Feb 13, 1996
A074477 002 Feb 13, 1996
A074477 003 Feb 13, 1996
A074477 004 Feb 13, 1996
A074640 001 Mar 31, 1997
A074640 002 Mar 31, 1997
A074640 003 Mar 31, 1997
A074640 004 Mar 31, 1997
A074481 001 Feb 13, 1996
A074519 001 Feb 13, 1996
A074481 002 Feb 13, 1996
A074519 002 Feb 13, 1996
A074481 003 Feb 13, 1996
A074519 003 Feb 13, 1996
A074481 004 Feb 13, 1996
A074519 004 Feb 13, 1996
A074433 001 Feb 13, 1996
A074483 001 Feb 13, 1996
A074433 002 Feb 13, 1996
A074483 002 Feb 13, 1996
A074433 003 Feb 13, 1996
A074483 003 Feb 13, 1996
A074433 004 Feb 13, 1996
A074483 004 Feb 13, 1996
A074462 001 Feb 13, 1996
A074462 002 Feb 13, 1996
A074462 003 Feb 13, 1996
A074462 004 Feb 13, 1996
A074418 001 Feb 13, 1996
A074418 002 Feb 13, 1996
A074418 003 Feb 13, 1996
A074418 004 Feb 13, 1996
A074576 001 Apr 23, 1996
A074576 002 Apr 23, 1996
A074576 003 Apr 23, 1996
A074576 004 Apr 23, 1996
A075055 001 Jun 18, 1998
A075055 002 Jun 18, 1998
A075055 004 Jun 18, 1998
A075055 003 Jun 18, 1998
A074788 001 Dec 29, 1997
A074788 002 Dec 29, 1997
A074788 004 Dec 29, 1997
A074788 003 Dec 29, 1997
A074832 001 Dec 29, 1997
A070292 001 May 21, 1986
A073677 001 Apr 28, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-53( of 322)
CARBAMAZEPINE
SUSPENSION;ORAL
CARBAMAZEPINE
TARO
TABLET;ORAL
CARBAMAZEPINE
100MG/5ML A075875 001 Dec 21, 2000
ACTAVIS ELIZABETH
INWOOD LABS
PLIVA
USL PHARMA
WARNER CHILCOTT
TERIL
200MG
200MG
200MG
200MG
200MG
A071696 001
A070231 001
A071479 001
A070300 001
A070429 001
Nov 09, 1987
Aug 14, 1986
Jul 24, 1987
May 15, 1986
Jan 02, 1987
TARO
TABLET, CHEWABLE;ORAL
CARBAMAZEPINE
200MG A076525 001 Sep 26, 2003
JUBILANT CADISTA 100MG A071940 001 Feb 01, 1988
CARBENICILLIN DISODIUM
INJECTABLE;INJECTION
GEOPEN
ROERIG
PYOPEN
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 30GM BASE/VIAL
N050306 001
N050306 004
N050306 002
N050306 006
N050306 007
GLAXOSMITHKLINE EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
N050298 001
N050298 002
N050298 003
N050298 006
N050298 007
CARBENICILLIN INDANYL SODIUM
TABLET;ORAL
GEOCILLIN
PFIZER EQ 382MG BASE N050435 001
CARBIDOPA; LEVODOPA
TABLET;ORAL
CARBIDOPA AND LEVODOPA
SANDOZ 10MG;100MG
25MG;100MG
25MG;250MG
SCS 10MG;100MG
25MG;100MG
25MG;250MG
WATSON LABS 10MG;100MG
25MG;100MG
25MG;250MG
TABLET, EXTENDED RELEASE;ORAL
CARBIDOPA AND LEVODOPA
A073586 001
A073587 001
A073620 001
A074080 001
A074080 002
A074080 003
A073381 001
A073382 001
A073383 001
Jun 29, 1995
Jun 29, 1995
Jun 29, 1995
Mar 25, 1994
Mar 25, 1994
Mar 25, 1994
Sep 28, 1993
Sep 28, 1993
Sep 28, 1993
KV PHARM
TABLET, FOR SUSPENSION;ORAL
CARBILEV
50MG;200MG A076663 001 Jun 24, 2004
RANBAXY 10MG;100MG
25MG;100MG
25MG;250MG
A076643 001
A076643 002
A076643 003
Jun 10, 2005
Jun 10, 2005
Jun 10, 2005
CARBINOXAMINE MALEATE
ELIXIR;ORAL
CLISTIN
MCNEIL
TABLET;ORAL
CLISTIN
4MG/5ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
N008955 001
ORTHO MCNEIL PHARM 4MG N008915 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-54( of 322)
CARBOPLATIN
INJECTABLE;INJECTION
CARBOPLATIN
HOSPIRA
PLIVA
PARAPLATIN
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
A076473 001
A076473 002
A076473 003
A076602 001
A076602 002
A076602 003
Oct 27, 2004
Oct 27, 2004
Oct 27, 2004
Nov 16, 2004
Nov 16, 2004
Nov 16, 2004
CORDEN PHARMA
INJECTABLE;IV (INFUSION)
CARBOPLATIN
50MG/VIAL
150MG/VIAL
450MG/VIAL
N019880 001
N019880 002
N019880 003
Mar 03, 1989
Mar 03, 1989
Mar 03, 1989
FRESENIUS KABI USA
PHARMACHEMIE BV
TEVA PARENTERAL
PARAPLATIN
50MG/5ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
150MG/15ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
A077247 001
A077266 001
A077247 002
A077266 002
A077679 001
A077679 002
A077679 003
A077389 001
A077389 002
A077389 003
Oct 21, 2004
Feb 15, 2006
Oct 21, 2004
Feb 15, 2006
Feb 25, 2009
Feb 25, 2009
Feb 25, 2009
Mar 30, 2007
Mar 30, 2007
Mar 30, 2007
CORDENPHARMA 50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
600MG/60ML (10MG/ML)
N020452 001
N020452 002
N020452 003
N020452 004
Jul 14, 2003
Jul 14, 2003
Jul 14, 2003
Jan 15, 2004
CARISOPRODOL
CAPSULE;ORAL
SOMA
MEDA PHARMS 250MG N011792 003
TABLET;ORAL
CARISOPRODOL
ABLE
COREPHARMA
PIONEER PHARMS
PROSAM LABS
SANDOZ
WATSON LABS
350MG
350MG
350MG
350MG
350MG
350MG
350MG
350MG
A040421 001
A040397 001
A089390 001
A040188 001
A081025 001
A089566 001
A040152 001
A085433 001
Jun 21, 2001
Sep 21, 2000
Oct 13, 1988
Mar 07, 1997
Apr 13, 1989
Aug 30, 1988
Dec 03, 1996
350MG A086179 001
WEST WARD
RELA
350MG A040124 001 Jan 24, 1996
SCHERING 350MG N012155 001
CARPHENAZINE MALEATE
CONCENTRATE;ORAL
PROKETAZINE
WYETH AYERST
TABLET;ORAL
PROKETAZINE
50MG/ML N014173 001
WYETH AYERST 12.5MG N012768 001
25MG N012768 002
50MG N012768 004
CARPROFEN
TABLET;ORAL
RIMADYL
ROCHE 100MG
150MG
N018550 002
N018550 003
Dec 31, 1987
Dec 31, 1987
CARTEOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CARTEOLOL HYDROCHLORIDE
APOTEX INC
TABLET;ORAL
CARTROL
1% A076097 001 Feb 06, 2002
ABBVIE 2.5MG
5MG
N019204 001
N019204 002
Dec 28, 1988
Dec 28, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-55( of 322)
CARTEOLOL HYDROCHLORIDE
TABLET;ORAL
CARTROL
10MG N019204 003 Dec 28, 1988
CARVEDILOL
TABLET;ORAL
CARVEDILOL
WOCKHARDT LTD 3.125MG
6.25MG
12.5MG
25MG
A078786 001
A078786 002
A078786 003
A078786 004
Dec 22, 2009
Dec 22, 2009
Dec 22, 2009
Dec 22, 2009
CEFACLOR
CAPSULE;ORAL
CECLOR
LILLY
CEFACLOR
EQ 250MG BASE
EQ 500MG BASE
N050521 001
N050521 002
CEPH INTL
CLONMEL HLTHCARE
IVAX SUB TEVA PHARMS
MARSAM PHARMS LLC
RANBAXY
TEVA
FOR SUSPENSION;ORAL
CECLOR
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
A062205 001
A062205 002
A064107 001
A064107 002
A064061 001
A064061 002
A064148 001
A064148 002
A064156 001
A064156 002
A064081 001
A064145 001
A064081 002
A064145 002
Apr 27, 1995
Apr 27, 1995
Apr 27, 1995
Apr 27, 1995
May 23, 1996
May 23, 1996
Aug 28, 1997
Aug 28, 1997
Sep 16, 1996
Jun 24, 1996
Sep 16, 1996
Jun 24, 1996
LILLY
CEFACLOR
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
N050522 001
N050522 002
CLONMEL HLTHCARE
FACTA FARMA
IVAX SUB TEVA PHARMS
MARSAM PHARMS LLC
RANBAXY
TABLET, CHEWABLE;ORAL
RANICLOR
EQ 125MG BASE/5ML
EQ 187MG BASE/5ML
EQ 250MG BASE/5ML
EQ 375MG BASE/5ML
EQ 125MG BASE/5ML
EQ 187MG BASE/5ML
EQ 250MG BASE/5ML
EQ 375MG BASE/5ML
EQ 125MG BASE/5ML
EQ 187MG BASE/5ML
EQ 250MG BASE/5ML
EQ 375MG BASE/5ML
EQ 125MG BASE/5ML
EQ 187MG BASE/5ML
EQ 250MG BASE/5ML
EQ 375MG BASE/5ML
EQ 125MG BASE/5ML
EQ 187MG BASE/5ML
EQ 250MG BASE/5ML
EQ 375MG BASE/5ML
A064114 001
A064115 001
A064116 001
A064110 001
A062206 001
A062206 003
A062206 002
A062206 004
A064087 001
A064086 001
A064085 001
A064070 001
A064204 001
A064205 001
A064206 001
A064207 001
A064166 001
A064165 001
A064164 001
A064155 001
Apr 28, 1995
Apr 28, 1995
Apr 28, 1995
Apr 28, 1995
Apr 20, 1988
Apr 20, 1988
Apr 28, 1995
Apr 28, 1995
Apr 28, 1995
Apr 28, 1995
Feb 18, 1998
Feb 18, 1998
Feb 18, 1998
Feb 18, 1998
Oct 02, 1997
Oct 02, 1997
Oct 02, 1997
Oct 02, 1997
RANBAXY LABS LTD EQ 125MG BASE
EQ 187MG BASE
EQ 250MG BASE
EQ 375MG BASE
TABLET, EXTENDED RELEASE;ORAL
CECLOR CD
A065092 001
A065092 002
A065092 003
A065092 004
Dec 22, 2003
Dec 22, 2003
Dec 22, 2003
Dec 22, 2003
LILLY
CEFACLOR
EQ 375MG BASE
EQ 500MG BASE
N050673 001
N050673 002
Jun 28, 1996
Jun 28, 1996
WORLD GEN EQ 500MG BASE A065057 001 Jan 05, 2001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CEFADROXIL/CEFADROXIL HEMIHYDRATE
CAPSULE;ORAL
CEFADROXIL
IVAX SUB TEVA PHARMS
PUREPAC PHARM
RANBAXY LABS LTD
TEVA
DURICEF
WARNER CHILCOTT
ULTRACEF
BRISTOL
FOR SUSPENSION;ORAL
CEFADROXIL
APOTHECON
TEVA
TEVA PHARMS USA
DURICEF
WARNER CHILCOTT
ULTRACEF
BRISTOL
TABLET;ORAL
CEFADROXIL
RANBAXY
DURICEF
WARNER CHILCOTT
ULTRACEF
APOTHECON
BRISTOL
CEFAMANDOLE NAFATE
INJECTABLE;INJECTION
MANDOL
LILLY
CEFAZOLIN SODIUM
INJECTABLE;INJECTION
ANCEF
GLAXOSMITHKLINE
ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 10MG BASE/ML
EQ 20MG BASE/ML
ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 1GM BASE
EQ 1GM BASE
EQ 1GM BASE
EQ 1GM BASE
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 10GM BASE/VIAL
EQ 250MG BASE/VIAL **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 500MG BASE/VIAL
BAXTER HLTHCARE
CEFAZOLIN AND DEXTROSE
B BRAUN
CEFAZOLIN SODIUM
ABRAXIS PHARM
EQ 10MG BASE/ML
EQ 20MG BASE/ML
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL
A062766 001
A063017 001
A065015 001
A062695 001
N050512 002
N050512 001
A062378 001
A062334 001
A062334 002
A062334 003
A062698 001
A062698 002
A062698 003
A065278 001
A065278 002
N050527 002
N050527 003
N050527 001
A062376 001
A062376 002
A062376 003
A065018 001
N050528 001
A062390 001
A062408 001
A062560 001
N050504 002
A062560 002
N050504 003
N050504 004
N050504 001
N050461 003
N050461 004
N050461 005
N050461 001
N050461 002
N050566 003
N050566 004
N050566 001
N050566 002
N050779 001
A062688 003
A062688 004
6-56( of 322)
Mar 03, 1987
Jan 05, 1989
Jun 22, 1999
Feb 10, 1989
Mar 16, 1982
Mar 01, 1989
Mar 01, 1989
Mar 01, 1989
Jan 20, 2006
Jan 20, 2006
Mar 16, 1982
Mar 16, 1982
Mar 16, 1982
Apr 23, 1999
Jun 10, 1982
Aug 31, 1982
Sep 10, 1985
Sep 10, 1985
Jun 08, 1983
Jun 08, 1983
Jun 08, 1983
Jun 08, 1983
Jul 27, 2000
Nov 17, 1986
Nov 17, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CEFAZOLIN SODIUM
INJECTABLE;INJECTION
CEFAZOLIN SODIUM
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
AUROBINDO PHARMA EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
BEDFORD EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
CEPHAZONE PHARMA EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
FRESENIUS KABI USA EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
GLAXOSMITHKLINE EQ 1GM BASE/VIAL
HIKMA MAPLE EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
MARSAM PHARMS LLC EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
TEVA PHARMS EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
KEFZOL
ACS DOBFAR EQ 20GM BASE/VIAL
EQ 250MG BASE/VIAL
LILLY EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
CEFDINIR
CAPSULE;ORAL
OMNICEF
ABBVIE 300MG
FOR SUSPENSION;ORAL
OMNICEF
ABBVIE 125MG/5ML
250MG/5ML
CEFEPIME HYDROCHLORIDE
INJECTABLE;INJECTION
CEFEPIME HYDROCHLORIDE
SANDOZ EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
CEFIXIME
FOR SUSPENSION;ORAL
SUPRAX
LEDERLE 100MG/5ML
TABLET;ORAL
SUPRAX
LEDERLE 200MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
400MG
A062688 005
A062688 002
A065395 002
A065395 001
A062894 003
A062894 004
A062894 005
A062894 001
A062894 002
A065280 002
A065295 001
A065296 001
A065280 001
A064169 002
A064170 001
A064170 002
A064169 001
A064033 001
A062807 003
A062807 004
A062807 005
A062807 006
A062807 001
A062807 002
A062988 003
A062989 001
A062989 002
A062989 003
A062988 001
A062988 002
A063016 003
A063018 001
A063018 002
A063016 001
A063016 002
A061773 005
A061773 001
A062557 002
A062557 001
N050739 001
N050749 001
N050749 002
A090291 002
A090291 003
A090291 001
N050622 001
N050621 001
N050621 002
6-57( of 322)
Aug 03, 1987
Nov 17, 1986
Aug 08, 2008
Aug 08, 2008
Jul 21, 1988
Jul 21, 1988
Jul 21, 1988
Jul 21, 1988
Jul 21, 1988
Mar 18, 2009
Mar 18, 2009
Mar 18, 2009
Mar 18, 2009
Aug 14, 1998
Mar 18, 1998
Mar 18, 1998
Aug 14, 1998
Oct 31, 1993
Jan 12, 1988
Jan 12, 1988
Jan 12, 1988
Jan 12, 1988
Jan 12, 1988
Jan 12, 1988
Dec 29, 1989
Dec 29, 1989
Dec 29, 1989
Dec 29, 1989
Dec 29, 1989
Dec 29, 1989
Mar 14, 1989
Mar 05, 1990
Mar 05, 1990
Mar 14, 1989
Mar 14, 1989
Sep 08, 1987
Sep 10, 1985
Sep 10, 1985
Dec 04, 1997
Dec 04, 1997
Jul 29, 2004
Dec 21, 2010
Dec 21, 2010
Dec 21, 2010
Apr 28, 1989
Apr 28, 1989
Apr 28, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-58( of 322)
CEFMENOXIME HYDROCHLORIDE
INJECTABLE;INJECTION
CEFMAX
TAP PHARM EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
N050571 002
N050571 003
N050571 001
Dec 30, 1987
Dec 30, 1987
Dec 30, 1987
CEFMETAZOLE SODIUM
INJECTABLE;INJECTION
ZEFAZONE
PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
ZEFAZONE IN PLASTIC CONTAINER
N050637 001
N050637 002
Dec 11, 1989
Dec 11, 1989
PHARMACIA AND UPJOHN EQ 20MG BASE/ML
EQ 40MG BASE/ML
N050683 001
N050683 002
Dec 29, 1992
Dec 29, 1992
CEFONICID SODIUM
INJECTABLE;INJECTION
MONOCID
GLAXOSMITHKLINE EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
A063295 001
N050579 002
N050579 003
N050579 004
N050579 001
Jul 26, 1993
May 23, 1984
May 23, 1984
May 23, 1984
May 23, 1984
CEFOPERAZONE SODIUM
INJECTABLE;INJECTION
CEFOBID
PFIZER EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
CEFOBID IN PLASTIC CONTAINER
A063333 001
N050551 001
A063333 002
N050551 002
N050551 003
Mar 31, 1995
Nov 18, 1982
Mar 31, 1995
Nov 18, 1982
Mar 05, 1990
PFIZER EQ 20MG BASE/ML
EQ 40MG BASE/ML
N050613 002
N050613 001
Jul 31, 1987
Jul 23, 1986
CEFORANIDE
INJECTABLE;INJECTION
PRECEF
APOTHECON
BRISTOL
1GM/VIAL
2GM/VIAL
10GM/VIAL
20GM/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL
10GM/VIAL
20GM/VIAL
500MG/VIAL
A062579 002
A062579 003
A062579 004
A062579 005
A062579 001
N050554 002
N050554 003
N050554 004
N050554 005
N050554 001
Nov 26, 1984
Nov 26, 1984
Nov 26, 1984
Nov 26, 1984
Nov 26, 1984
May 24, 1984
May 24, 1984
May 24, 1984
May 24, 1984
May 24, 1984
CEFOTAXIME SODIUM
INJECTABLE;INJECTION
CEFOTAXIME
FRESENIUS KABI USA EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
A064200 002
A064200 003
A064201 001
A064201 002
A064200 001
Mar 24, 2000
Mar 24, 2000
Mar 24, 2000
Mar 24, 2000
Mar 24, 2000
B BRAUN EQ 2GM BASE
CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
N050792 001 Jul 29, 2004
B BRAUN
CEFOTAXIME SODIUM
EQ 1GM BASE N050792 002 Jul 29, 2004
AUROBINDO PHARMA EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
AUROBINDO PHARMA LTD EQ 10GM BASE/VIAL
CEPHAZONE PHARMA EQ 10GM BASE/VIAL
CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
A065517 002
A065517 003
A065517 001
A065516 001
A065348 001
Nov 06, 2009
Nov 06, 2009
Nov 06, 2009
Nov 06, 2009
Jan 25, 2010
SANOFI AVENTIS US EQ 20MG BASE/ML
EQ 40MG BASE/ML
N050596 001
N050596 003
May 20, 1985
May 20, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-59( of 322)
CEFOTETAN DISODIUM
INJECTABLE;INJECTION
CEFOTAN
ASTRAZENECA EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
CEFOTAN IN PLASTIC CONTAINER
A063293 001
N050588 001
A063293 002
N050588 002
N050588 003
Apr 29, 1993
Dec 27, 1985
Apr 29, 1993
Dec 27, 1985
Apr 25, 1988
ASTRAZENECA EQ 20MG BASE/ML
EQ 40MG BASE/ML
N050694 002
N050694 001
Jul 30, 1993
Jul 30, 1993
CEFOTIAM HYDROCHLORIDE
INJECTABLE;INJECTION
CERADON
TAKEDA EQ 1GM BASE/VIAL N050601 001 Dec 30, 1988
CEFOXITIN SODIUM
INJECTABLE;INJECTION
CEFOXITIN
FRESENIUS KABI USA
MEFOXIN
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
A065012 001
A065012 002
A065011 001
Jul 03, 2000
Jul 03, 2000
Jul 03, 2000
MYLAN INSTITUTIONAL EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
A062757 001
N050517 001
A062757 002
N050517 002
N050517 003
Jan 08, 1987
Jan 08, 1987
MERCK EQ 20MG BASE/ML
EQ 40MG BASE/ML
MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
N050581 003
N050581 004
Sep 20, 1984
Sep 20, 1984
MERCK EQ 20MG BASE/ML
EQ 40MG BASE/ML
N050581 002
N050581 001
Sep 20, 1984
Sep 20, 1984
CEFPIRAMIDE SODIUM
INJECTABLE;INJECTION
CEFPIRAMIDE SODIUM
WYETH AYERST EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
N050633 002
N050633 003
N050633 005
Jan 31, 1989
Jan 31, 1989
Jan 31, 1989
CEFPODOXIME PROXETIL
FOR SUSPENSION;ORAL
BANAN
SANKYO
VANTIN
EQ 50MG BASE/5ML
EQ 100MG BASE/5ML
N050688 002
N050688 001
Aug 07, 1992
Aug 07, 1992
PHARMACIA AND UPJOHN
TABLET;ORAL
BANAN
EQ 50MG BASE/5ML
EQ 100MG BASE/5ML
N050675 001
N050675 002
Aug 07, 1992
Aug 07, 1992
SANKYO
VANTIN
EQ 100MG BASE
EQ 200MG BASE
N050687 001
N050687 002
Aug 07, 1992
Aug 07, 1992
PHARMACIA AND UPJOHN EQ 100MG BASE
EQ 200MG BASE
N050674 001
N050674 002
Aug 07, 1992
Aug 07, 1992
CEFPROZIL
FOR SUSPENSION;ORAL
CEFPROZIL
RANBAXY LABS LTD
CEFZIL
125MG/5ML
250MG/5ML
A065202 001
A065202 002
Jun 30, 2006
Jun 30, 2006
CORDEN PHARMA
TABLET;ORAL
CEFPROZIL
125MG/5ML
250MG/5ML
N050665 001
N050665 002
Dec 23, 1991
Dec 23, 1991
RANBAXY LABS LTD
CEFZIL
250MG
500MG
A065198 001
A065198 002
Dec 13, 2006
Dec 13, 2006
CORDEN PHARMA 250MG
500MG
N050664 001
N050664 002
Dec 23, 1991
Dec 23, 1991
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-60( of 322)
CEFTAZIDIME
INJECTABLE;INJECTION
CEFTAZIDIME
AUROBINDO PHARMA LTD
CEPTAZ
1GM/VIAL
2GM/VIAL
6GM/VIAL
500MG/VIAL
A065481 002
A065481 003
A065482 001
A065481 001
May 28, 2010
May 28, 2010
May 28, 2010
May 28, 2010
GLAXOSMITHKLINE
PENTACEF
1GM/VIAL
2GM/VIAL
10GM/VIAL
500MG/VIAL
N050646 002
N050646 003
N050646 004
N050646 001
Sep 27, 1990
Sep 27, 1990
Sep 27, 1990
Sep 27, 1990
GLAXOSMITHKLINE
TAZIDIME
1GM/VIAL
1GM/VIAL
2GM/VIAL
2GM/VIAL
6GM/VIAL
10GM/VIAL
A063322 001
A064006 001
A063322 002
A064006 002
A064008 001
A064008 002
Nov 07, 1995
Mar 31, 1992
Nov 07, 1995
Mar 31, 1992
Mar 31, 1992
Mar 31, 1992
LILLY 1GM/VIAL
2GM/VIAL
TAZIDIME IN PLASTIC CONTAINER
A062655 001
A062655 002
Nov 20, 1985
Nov 20, 1985
LILLY 1GM/VIAL
2GM/VIAL
A062739 001
A062739 002
Jul 10, 1986
Jul 10, 1986
CEFTAZIDIME SODIUM
INJECTABLE;INJECTION
CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 10MG BASE/ML
EQ 20MG BASE/ML
EQ 40MG BASE/ML
FORTAZ IN PLASTIC CONTAINER
A063221 001
A063221 002
A063221 003
Apr 29, 1993
Apr 29, 1993
Apr 29, 1993
COVIS PHARMA EQ 10MG BASE/ML N050634 001 Apr 28, 1989
CEFTIBUTEN DIHYDRATE
FOR SUSPENSION;ORAL
CEDAX
PERNIX THERAP EQ 180MG BASE/5ML N050686 002 Dec 20, 1995
CEFTIZOXIME SODIUM
INJECTABLE;INJECTION
CEFIZOX
ASTELLAS EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER
A063294 002
N050560 002
A063294 003
N050560 003
N050560 005
N050560 001
Mar 31, 1994
Sep 15, 1983
Mar 31, 1994
Sep 15, 1983
Mar 19, 1993
Sep 15, 1983
ASTELLAS EQ 20MG BASE/ML
EQ 40MG BASE/ML
CEFIZOX IN PLASTIC CONTAINER
N050589 001
N050589 002
Oct 03, 1984
Oct 03, 1984
ASTELLAS EQ 20MG BASE/ML
EQ 40MG BASE/ML
N050589 003
N050589 004
Apr 13, 1995
Apr 13, 1995
CEFTRIAXONE SODIUM
INJECTABLE;IM-IV
CEFTRIAXONE
AUROBINDO PHARMA LTD
CEPHAZONE PHARMA
FRESENIUS KABI USA
STERI PHARMA
TEVA
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
A065505 003
A065505 004
A065505 001
A065505 002
A065294 003
A065294 004
A065294 001
A065294 002
A065245 003
A065245 004
A065245 002
A065268 001
A065268 002
A065262 001
A065262 002
Jul 31, 2008
Jul 31, 2008
Jul 31, 2008
Jul 31, 2008
Mar 26, 2007
Mar 26, 2007
Mar 26, 2007
Mar 26, 2007
Feb 15, 2006
Feb 15, 2006
Feb 15, 2006
Feb 28, 2007
Feb 28, 2007
Jun 29, 2006
Jun 29, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-61( of 322)
CEFTRIAXONE SODIUM
INJECTABLE;IM-IV
ROCEPHIN
HOFFMANN LA ROCHE
INJECTABLE;INJECTION
CEFTRIAXONE
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
N050585 003
N050585 004
N050585 001
N050585 002
Dec 21, 1984
Dec 21, 1984
Dec 21, 1984
Dec 21, 1984
AUROBINDO PHARMA LTD
FRESENIUS KABI USA
TEVA
ROCEPHIN
EQ 10GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 10GM BASE/VIAL
A065504 001
A065252 001
A065274 001
Jul 31, 2008
Feb 15, 2006
May 01, 2006
HOFFMANN LA ROCHE EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
ROCHE EQ 1GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
HOFFMANN LA ROCHE EQ 10MG BASE/ML
EQ 20MG BASE/ML
EQ 40MG BASE/ML
A062654 002
A062654 003
N050585 005
A063239 001
A062654 001
A062510 003
A062510 001
A062510 002
N050624 001
N050624 002
N050624 003
Apr 30, 1987
Apr 30, 1987
Dec 21, 1984
Aug 13, 1993
Apr 30, 1987
Mar 12, 1985
Mar 12, 1985
Mar 12, 1985
Feb 11, 1987
Feb 11, 1987
Feb 11, 1987
CEFTRIAXONE SODIUM; LIDOCAINE
INJECTABLE;INJECTION
ROCEPHIN KIT
HOFFMANN LA ROCHE EQ 1GM BASE/VIAL,N/A;N/A,1%
EQ 500MG BASE/VIAL,N/A;N/A,1%
N050585 006
N050585 007
May 08, 1996
May 08, 1996
CEFUROXIME AXETIL
TABLET;ORAL
CEFUROXIME AXETIL
RANBAXY LABS LTD
SANDOZ
EQ 125MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
A065043 003
A065043 002
A065043 001
A065126 001
A065126 002
Feb 15, 2002
Feb 15, 2002
Feb 15, 2002
Oct 28, 2003
Oct 28, 2003
CEFUROXIME SODIUM
INJECTABLE;IM-IV
CEFUROXIME SODIUM
FRESENIUS KABI USA
MARSAM PHARMS LLC
TEVA PHARMS
KEFUROX
EQ 750MG BASE/VIAL
EQ 750MG BASE/VIAL
EQ 1.5GM BASE/VIAL
EQ 750MG BASE/VIAL
A065001 001
A064035 001
A064192 001
A064192 002
May 30, 2001
Feb 26, 1993
Apr 16, 1998
Apr 16, 1998
ACS DOBFAR
INJECTABLE;INJECTION
CEFUROXIME SODIUM
EQ 750MG BASE/VIAL A062591 001 Jan 10, 1986
FRESENIUS KABI USA EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
MARSAM PHARMS LLC EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
CEFUROXIME SODIUM IN PLASTIC CONTAINER
A065001 002
A065002 001
A064035 002
A064036 001
May 30, 2001
Sep 28, 1998
Feb 26, 1993
Feb 26, 1993
SAMSON MEDCL
KEFUROX
EQ 75GM BASE/VIAL
EQ 225GM BASE/VIAL
A065251 001
A065251 002
Dec 30, 2009
Dec 30, 2009
ACS DOBFAR EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
LILLY EQ 1.5GM BASE/VIAL
KEFUROX IN PLASTIC CONTAINER
A062591 002
A062591 003
A062592 002
Jan 10, 1986
Dec 17, 1987
Jan 10, 1986
LILLY EQ 1.5GM BASE/VIAL
ZINACEF IN PLASTIC CONTAINER
A062590 002 Jan 10, 1986
COVIS PHARMA SARL
INJECTABLE;INTRAVENOUS
KEFUROX
EQ 15MG BASE/ML N050643 001 Apr 28, 1989
LILLY EQ 750MG BASE/VIAL
KEFUROX IN PLASTIC CONTAINER
A062592 001 Jan 10, 1986
LILLY EQ 750MG BASE/VIAL A062590 001 Jan 10, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CELLULOSE SODIUM PHOSPHATE
POWDER;ORAL
CALCIBIND
MISSION PHARMA 2.5GM/PACKET
300GM/BOT
CEPHALEXIN
CAPSULE;ORAL
CEPHALEXIN
APOTHECON EQ 250MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
BARR EQ 250MG BASE
EQ 500MG BASE
IVAX SUB TEVA PHARMS EQ 250MG BASE
EQ 500MG BASE
PUREPAC PHARM EQ 250MG BASE
EQ 500MG BASE
STEVENS J EQ 500MG BASE
TEVA EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
YOSHITOMI EQ 250MG BASE
EQ 500MG BASE
KEFLEX
SHIONOGI INC EQ 333MG BASE **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
FOR SUSPENSION;ORAL
CEPHALEXIN
APOTHECON EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
BARR EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
FACTA FARMA EQ 100MG BASE/ML
TEVA EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
VITARINE EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
KEFLEX
SHIONOGI INC EQ 100MG BASE/ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
TABLET;ORAL
CEPHALEXIN
BARR EQ 250MG BASE
EQ 500MG BASE
VITARINE EQ 1GM BASE
EQ 250MG BASE
EQ 500MG BASE
KEFLET
LILLY EQ 1GM BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
TABLET, FOR SUSPENSION;ORAL
PANIXINE DISPERDOSE
RANBAXY LABS LTD EQ 125MG BASE
EQ 250MG BASE
N018757 002
N018757 003
A062973 001
A063063 001
A063186 001
A062974 001
A063063 002
A063186 002
A062773 001
A062775 001
A061969 001
A061969 002
A062809 001
A062809 002
A062869 001
A062760 001
A062821 001
A062761 001
A062823 001
A062872 001
A062871 001
N050405 004
A062986 001
A062987 001
A062778 001
A062777 001
A062117 001
A062767 001
A062873 001
A062768 001
A062867 001
A062779 001
A062781 001
N050406 003
N050406 001
N050406 002
A062826 001
A062827 001
A062863 003
A062863 001
A062863 002
N050440 002
A062745 001
N050440 003
A062745 002
N050440 001
A065100 002
A065100 001
6-62( of 322)
Dec 28, 1982
Oct 16, 1984
Nov 08, 1988
Sep 29, 1989
Dec 30, 1994
Nov 23, 1988
Sep 29, 1989
Dec 30, 1994
Jun 26, 1987
Apr 22, 1987
Apr 22, 1987
Apr 22, 1987
Mar 17, 1988
Apr 24, 1987
Feb 05, 1988
Apr 24, 1987
Feb 05, 1988
Jun 20, 1988
Jul 05, 1988
May 12, 2006
Apr 18, 1991
Jul 25, 1989
Aug 06, 1987
Aug 06, 1987
Jun 16, 1987
May 23, 1988
Jun 16, 1987
Apr 15, 1988
Dec 22, 1987
Dec 22, 1987
Aug 17, 1987
Aug 17, 1987
Aug 11, 1988
Aug 11, 1988
Aug 11, 1988
Dec 01, 1986
Feb 26, 1987
Dec 01, 1986
Sep 11, 2003
Sep 11, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CEPHALEXIN HYDROCHLORIDE
TABLET;ORAL
KEFTAB
LILLY EQ 250MG BASE
EQ 333MG BASE
EQ 500MG BASE
CEPHALOGLYCIN
CAPSULE;ORAL
KAFOCIN
LILLY 250MG
CEPHALOTHIN SODIUM
INJECTABLE;INJECTION
CEPHALOTHIN
INTL MEDICATION EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 500MG BASE/VIAL
CEPHALOTHIN SODIUM
ABBOTT EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
ABRAXIS PHARM EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
BRISTOL EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 20MG BASE/ML
EQ 20MG BASE/ML
EQ 20MG BASE/ML
EQ 40MG BASE/ML
EQ 40MG BASE/ML
EQ 40MG BASE/ML
CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 20MG BASE/ML
EQ 40MG BASE/ML
KEFLIN
LILLY EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 20GM BASE/VIAL
KEFLIN IN PLASTIC CONTAINER
LILLY EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
SEFFIN
GLAXOSMITHKLINE EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
CEPHAPIRIN SODIUM
INJECTABLE;INJECTION
CEFADYL
APOTHECON EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
CEPHAPIRIN SODIUM
ABRAXIS PHARM EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 20GM BASE/VIAL
6-63( of 322)
N050614 001 Oct 29, 1987
N050614 003 May 16, 1988
N050614 002 Oct 29, 1987
N050219 001
A062426 002 May 03, 1985
A062426 003 May 03, 1985
A062426 004 May 03, 1985
A062426 001 May 03, 1985
A062547 001 Sep 11, 1985
A062548 001 Sep 11, 1985
A062547 002 Sep 11, 1985
A062548 002 Sep 11, 1985
A062666 002 Jun 10, 1987
A062666 001 Jun 10, 1987
A062464 001 May 07, 1984
A062464 002 May 07, 1984
A062464 003 May 07, 1984
A062422 003 Jan 31, 1984
A062422 005 Jul 16, 1991
A062730 001 Mar 05, 1987
A062422 004 Jan 31, 1984
A062422 006 Jul 16, 1991
A062730 002 Mar 05, 1987
A062422 001 Jan 31, 1984
A062422 002 Jan 31, 1984
N050482 001
N050482 002
N050482 003
N050482 007
A062549 001 Sep 10, 1985
A062549 002 Sep 10, 1985
A062435 001 Nov 15, 1983
A062435 002 Nov 15, 1983
A062435 003 Nov 15, 1983
A061769 001
A062724 001 Dec 23, 1986
A062961 002 Sep 20, 1988
N050446 001
A061769 002
A062724 002 Dec 23, 1986
A062961 003 Sep 20, 1988
N050446 002
A061769 003
A062961 004 Sep 20, 1988
N050446 003
N050446 004
A062961 001 Sep 20, 1988
N050446 005
A062723 002 Nov 17, 1986
A062723 003 Nov 17, 1986
A062723 004 Nov 17, 1986
A062723 005 Nov 17, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-64( of 322)
CEPHAPIRIN SODIUM
INJECTABLE;INJECTION
CEPHAPIRIN SODIUM
HIKMA MAPLE
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
A062723 001
A062720 002
A062720 003
A062720 004
A062720 001
Nov 17, 1986
Jul 02, 1987
Jul 02, 1987
Jul 02, 1987
Jul 02, 1987
CEPHRADINE
CAPSULE;ORAL
ANSPOR
GLAXOSMITHKLINE 250MG A061859 001
500MG A061859 002
CEPHRADINE
BARR
IVAX SUB TEVA PHARMS
TEVA
VITARINE
VELOSEF
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
A062850 001
A062851 001
A062762 001
A062762 002
A062683 001
A062683 002
A062813 001
A062813 002
Apr 22, 1988
Apr 22, 1988
Mar 06, 1987
Mar 06, 1987
Jan 09, 1987
Jan 09, 1987
Feb 25, 1988
Feb 25, 1988
APOTHECON 250MG A061764 001
500MG A061764 002
VELOSEF '250'
ERSANA 250MG N050548 001
VELOSEF '500'
ERSANA 500MG N050548 002
FOR SUSPENSION;ORAL
ANSPOR
GLAXOSMITHKLINE
CEPHRADINE
125MG/5ML
250MG/5ML
A061866 001
A061866 002
BARR
TEVA
VELOSEF '125'
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
A062858 001
A062859 001
A062693 001
A062693 002
May 19, 1988
May 19, 1988
Jan 09, 1987
Jan 09, 1987
APOTHECON
VELOSEF '250'
125MG/5ML A061763 001
APOTHECON
INJECTABLE;INJECTION
VELOSEF
250MG/5ML A061763 002
APOTHECON
TABLET;ORAL
VELOSEF
1GM/VIAL
2GM/VIAL
4GM/VIAL
250MG/VIAL
500MG/VIAL
A061976 004
A061976 003
A061976 005
A061976 001
A061976 002
BRISTOL MYERS SQUIBB 1GM N050530 001
CERIVASTATIN SODIUM
TABLET;ORAL
BAYCOL
BAYER PHARMS 0.05MG
0.1MG
0.2MG
0.3MG
0.4MG
0.8MG
N020740 001
N020740 002
N020740 003
N020740 004
N020740 005
N020740 006
Jun 26, 1997
Jun 26, 1997
Jun 26, 1997
Jun 26, 1997
May 24, 1999
Jul 24, 2000
CERULETIDE DIETHYLAMINE
INJECTABLE;INJECTION
TYMTRAN
PHARMACIA AND UPJOHN 0.02MG/ML N018296 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CETIRIZINE HYDROCHLORIDE
SYRUP;ORAL
CETIRIZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 5MG/5ML
APOTEX INC 5MG/5ML
AUROBINDO PHARMA LTD 5MG/5ML
RANBAXY LABS LTD 5MG/5ML
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS MID ATLANTIC 5MG/5ML
APOTEX INC 5MG/5ML
RANBAXY LABS LTD 5MG/5ML
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ACTAVIS MID ATLANTIC 5MG/5ML
APOTEX INC 5MG/5ML
RANBAXY LABS LTD 5MG/5ML
TABLET;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS ELIZABETH 5MG
10MG
TABLET, CHEWABLE;ORAL
CHILDREN'S ZYRTEC ALLERGY
MCNEIL CONS 5MG
10MG
CHILDREN'S ZYRTEC HIVES RELIEF
MCNEIL CONS 5MG
10MG
CETRORELIX
INJECTABLE;INJECTION
CETROTIDE
EMD SERONO INC EQ 3MG BASE/ML
CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL
FOR SUSPENSION;INTRATRACHEAL
EXOSURF NEONATAL
GLAXOSMITHKLINE
CHENODIOL
TABLET;ORAL
CHENIX
SIGMA TAU
CHLOPHEDIANOL HYDROCHLORIDE
SYRUP;ORAL
ULO
3M
CHLORAMPHENICOL
CAPSULE;ORAL
AMPHICOL
FERRANTE
CHLOROMYCETIN
PARKEDALE
CREAM;TOPICAL
CHLOROMYCETIN
PARKE DAVIS
FOR SOLUTION;OPHTHALMIC
CHLOROMYCETIN
PARKEDALE
INJECTABLE;INJECTION
CHLOROMYCETIN
PARKE DAVIS
OINTMENT;OPHTHALMIC
CHLORAMPHENICOL
ALTANA
CHLOROFAIR
PHARMAFAIR
CHLOROMYCETIN
PARKEDALE
CHLOROPTIC S.O.P.
ALLERGAN
ECONOCHLOR
ALCON
12MG/VIAL;108MG/VIAL;8MG/VIAL
250MG
25MG/5ML
100MG
50MG
100MG
1%
25MG/VIAL
250MG/ML
1%
1%
1%
1%
1%
6-65( of 322)
A078617 001 Feb 02, 2010
A078412 001 Jun 18, 2008
A090751 001 Dec 16, 2009
A077472 001 Jun 18, 2008
A090378 002 May 09, 2008
A090188 002 Apr 22, 2008
A090183 002 Apr 24, 2008
A090378 001 May 09, 2008
A090188 001 Apr 22, 2008
A090183 001 Apr 24, 2008
A078615 003 Dec 28, 2007
A078615 004 Dec 28, 2007
N021621 003 Nov 16, 2007
N021621 004 Nov 16, 2007
N021621 005 Nov 16, 2007
N021621 006 Nov 16, 2007
N021197 002 Aug 11, 2000
N020044 001 Aug 02, 1990
N018513 002 Jul 28, 1983
N012126 001
A060058 001
A060591 001
A060591 003
N050183 001
N050143 001
N050153 001
A060133 001
A062439 001 Apr 21, 1983
N050156 001
A061187 001
A061648 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CHLORAMPHENICOL
SOLUTION/DROPS;OPHTHALMIC
CHLORAMPHENICOL
AKORN 0.5%
ALCON 0.5%
CHLOROFAIR
PHARMAFAIR 0.5%
CHLOROPTIC
ALLERGAN 0.5%
ECONOCHLOR
ALCON 0.5%
OPHTHOCHLOR
PARKEDALE 0.5%
OPTOMYCIN
OPTOPICS 0.5%
SOLUTION/DROPS;OTIC
CHLOROMYCETIN
PARKEDALE 0.5%
CHLORAMPHENICOL PALMITATE
SUSPENSION;ORAL
CHLOROMYCETIN PALMITATE
PARKE DAVIS EQ 150MG BASE/5ML
EQ 150MG BASE/5ML
CHLORAMPHENICOL SODIUM SUCCINATE
INJECTABLE;INJECTION
CHLORAMPHENICOL
ELKINS SINN EQ 1GM BASE/VIAL
CHLORAMPHENICOL SODIUM SUCCINATE
GRUPPO LEPETIT EQ 1GM BASE/VIAL
CHLOROMYCETIN
PARKEDALE EQ 1GM BASE/VIAL
MYCHEL-S
ANGUS EQ 1GM BASE/VIAL
CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSIN
OINTMENT;TOPICAL
ELASE-CHLOROMYCETIN
PARKE DAVIS 10MG/GM;666 UNITS/GM;1 UNITS/GM
CHLORAMPHENICOL; HYDROCORTISONE ACETATE
FOR SUSPENSION;OPHTHALMIC
CHLOROMYCETIN HYDROCORTISONE
PARKEDALE 12.5MG/VIAL;25MG/VIAL
CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
OPHTHOCORT
PARKEDALE 10MG/GM;5MG/GM;10,000 UNITS/GM
CHLORAMPHENICOL; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
CHLOROMYXIN
PARKE DAVIS 1%;10,000 UNITS/GM
CHLORAMPHENICOL; PREDNISOLONE
OINTMENT;OPHTHALMIC
CHLOROPTIC-P S.O.P.
ALLERGAN 1%;0.5%
CHLORDIAZEPOXIDE
CAPSULE, EXTENDED RELEASE;ORAL
LIBRELEASE
VALEANT PHARM INTL 30MG
TABLET;ORAL
LIBRITABS
VALEANT PHARM INTL 5MG
10MG
25MG
6-66( of 322)
A062042 001
A062628 001 Sep 25, 1985
A062437 001 Apr 14, 1983
N050091 001
A061645 001
A061220 001
A062171 001 Mar 31, 1982
N050205 001
A062301 001
N050152 001
A062406 001 Nov 09, 1982
A062278 001
N050155 001
A060132 001
N050294 001
N050202 001
N050201 002
N050203 002
A061188 001
N017813 001 Sep 12, 1983
A085482 001
A085481 001
A085488 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE;ORAL
A-POXIDE
ABBOTT 5MG
5MG
10MG
10MG
25MG
25MG
CHLORDIAZACHEL
RACHELLE 5MG
10MG
25MG
CHLORDIAZEPOXIDE HYDROCHLORIDE
ASCOT 5MG
10MG
25MG
FERRANTE 5MG
10MG
25MG
HALSEY 5MG
10MG
25MG
IMPAX LABS 5MG
10MG
25MG
IVAX SUB TEVA PHARMS 5MG
10MG
25MG
LEDERLE 5MG
5MG
10MG
10MG
25MG
25MG
MAST MM 10MG
MYLAN 5MG
10MG
25MG
PARKE DAVIS 5MG
10MG
25MG
PIONEER PHARMS 10MG
25MG
PUREPAC PHARM 5MG
10MG
25MG
ROXANE 5MG
10MG
25MG
SANDOZ 5MG
5MG
10MG
10MG
25MG
25MG
SUPERPHARM 5MG
10MG
25MG
TEVA 5MG
10MG
25MG
25MG
USL PHARMA 5MG
25MG
VANGARD 5MG
10MG
25MG
WEST WARD 5MG
10MG
25MG
6-67( of 322)
A085447 001
A085517 001
A085447 002
A085518 001
A085447 003
A085513 001
A085086 001
A084639 001
A085087 001
A087525 001 Jan 07, 1982
A087524 001 Jan 07, 1982
A087512 001 Jan 07, 1982
A085118 001
A085119 001
A085120 001
A085340 001
A085339 001
A084685 001
A086213 001
A085113 001
A086212 001
A083741 001
A083742 001
A083570 001
A086892 001
A087234 001
A086876 001
A087037 001
A086893 001
A087231 001
A086217 001
A084886 001
A084601 001
A084887 001
A085163 001
A084598 001
A085164 001
A089533 001 Jul 15, 1988
A089558 001 Jul 15, 1988
A085155 001
A084939 002
A085144 001
A084706 001
A084700 001
A084705 001
A084678 001
A084919 001
A084041 001
A084920 001
A084679 002
A084823 001
A088987 001 Apr 25, 1985
A088986 001 Apr 25, 1985
A088988 001 Apr 25, 1985
A088705 001 Jan 18, 1985
A088706 001 Jan 18, 1985
A086494 001
A088707 001 Jan 18, 1985
A084644 001
A084645 001
A088129 001 Mar 28, 1983
A088010 001 Mar 28, 1983
A088130 001 Mar 28, 1983
A085014 001
A085000 001
A085294 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-68( of 322)
CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE;ORAL
LIBRIUM
VALEANT PHARM INTL 5MG N012249 002
10MG N012249 001
25MG N012249 003
LYGEN
ALRA 5MG A085107 001
10MG A085009 001
25MG A085108 001
INJECTABLE;INJECTION
LIBRIUM
VALEANT PHARMS LLC 100MG/AMP N012301 001
CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED
TABLET;ORAL
MENRIUM 10-4
ROCHE
MENRIUM 5-2
10MG;0.4MG N014740 006
ROCHE
MENRIUM 5-4
5MG;0.2MG N014740 002
ROCHE 5MG;0.4MG N014740 004
CHLORHEXIDINE GLUCONATE
SOLUTION;DENTAL
CHLORHEXIDINE GLUCONATE
APOTEX INC
SOLUTION;TOPICAL
EXIDINE
0.12% A075561 001 Nov 14, 2000
XTTRIUM
MICRODERM
2.5% N019421 001 Dec 17, 1985
J AND J
PREVACARE R
4% A072255 001 Apr 15, 1991
J AND J
STERI-STAT
0.5% A072292 001 Jan 28, 1992
MATRIX MEDCL
SPONGE;TOPICAL
CHLORHEXIDINE GLUCONATE
4% A070104 001 Jul 24, 1986
KENDALL IL
E-Z SCRUB
4% N019490 001 Mar 27, 1987
BECTON DICKINSON
HIBICLENS
4% A073416 001 Mar 14, 2000
MOLNLYCKE HLTH 4% **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N018423 001
MICRODERM
J AND J 4% A072295 001 Feb 28, 1991
CHLORMERODRIN HG-197
INJECTABLE;INJECTION
CHLORMERODRIN HG 197
BRACCO 0.6-1.4mCi/ML N017269 001
CHLORMEZANONE
TABLET;ORAL
TRANCOPAL
SANOFI AVENTIS US 100MG N011467 003
200MG N011467 005
CHLOROPROCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
NESACAINE-MPF
FRESENIUS KABI USA 2% N009435 003
3% N009435 004
CHLOROQUINE HYDROCHLORIDE
INJECTABLE;INJECTION
ARALEN HYDROCHLORIDE
SANOFI AVENTIS US EQ 40MG BASE/ML N006002 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
CHLOROQUINE PHOSPHATE
TABLET;ORAL
CHLOROQUINE PHOSPHATE
MD PHARM
PUREPAC PHARM
TEVA
WATSON LABS
DISCONTINUED DRUG PRODUCT LIST
EQ 150MG BASE
EQ 150MG BASE
EQ 150MG BASE
EQ 150MG BASE
EQ 300MG BASE
CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
TABLET;ORAL
ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE
SANOFI AVENTIS US
CHLOROTHIAZIDE
TABLET;ORAL
CHLOROTHIAZIDE
ABC HOLDING
LEDERLE
SANDOZ
WATSON LABS
WEST WARD
DIURIL
OAK PHARMS AKORN
CHLOROTHIAZIDE; METHYLDOPA
TABLET;ORAL
ALDOCLOR-150
MERCK
ALDOCLOR-250
MERCK
EQ 300MG BASE;EQ 45MG BASE
250MG
250MG
500MG
250MG
250MG
250MG
250MG
500MG
500MG
250MG
500MG
250MG
500MG
150MG;250MG
250MG;250MG
METHYLDOPA AND CHLOROTHIAZIDE
PAR PHARM 150MG;250MG
250MG;250MG
CHLOROTHIAZIDE; RESERPINE
TABLET;ORAL
CHLOROTHIAZIDE AND RESERPINE
WEST WARD
CHLOROTHIAZIDE W/ RESERPINE
WATSON LABS
CHLOROTHIAZIDE-RESERPINE
MYLAN
DIUPRES-250
MERCK
DIUPRES-500
MERCK
CHLOROTRIANISENE
CAPSULE;ORAL
CHLOROTRIANISENE
BANNER PHARMACAPS
TACE
SANOFI AVENTIS US
CHLOROXINE
SHAMPOO;TOPICAL
CAPITROL
WESTWOOD SQUIBB
250MG;0.125MG
500MG;0.125MG
250MG;0.125MG
500MG;0.125MG
250MG;0.125MG
500MG;0.125MG
250MG;0.125MG
500MG;0.125MG
12MG
12MG
25MG
72MG
2%
6-69( of 322)
A087228 001
A080886 001
A087504 001 Jan 13, 1982
A087979 001 Dec 21, 1982
A088030 001 Dec 21, 1982
N014860 002
A085569 001
A086940 001
A086938 001
A085485 001
A085165 001
A085173 001
A086795 001 Aug 15, 1983
A084026 001 Sep 01, 1982
A086796 001 Aug 15, 1983
A086028 001 Jul 14, 1982
A087736 001 Jul 14, 1982
N011145 004
N011145 002
N016016 001
N016016 002
A070783 001 Nov 06, 1987
A070654 001 Nov 06, 1987
A088557 001 Dec 22, 1983
A088365 001 Dec 22, 1983
A084853 001
A088151 001 Jun 09, 1983
A087744 001 May 06, 1982
A087745 001 May 06, 1982
N011635 003 Aug 26, 1987
N011635 006 Aug 26, 1987
A084652 001
N008102 004
N011444 001
N016235 001
N017594 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-70( of 322)
CHLORPHENESIN CARBAMATE
TABLET;ORAL
MAOLATE
PHARMACIA AND UPJOHN 400MG N014217 002
CHLORPHENIRAMINE MALEATE
CAPSULE, EXTENDED RELEASE;ORAL
CHLORPHENIRAMINE MALEATE
SANDOZ
TELDRIN
12MG A070797 001 Aug 12, 1988
GLAXOSMITHKLINE 8MG N017369 001
12MG N017369 002
INJECTABLE;INJECTION
CHLOR-TRIMETON
SCHERING PLOUGH
CHLORPHENIRAMINE MALEATE
10MG/ML
100MG/ML
N008826 001
N008794 001
BEL MAR
ELKINS SINN
WATSON LABS
PYRIDAMAL 100
10MG/ML
10MG/ML
10MG/ML
10MG/ML
100MG/ML
A080821 001
A080797 001
A083593 001
A086096 001
A086095 001
BEL MAR
SYRUP;ORAL
100MG/ML A083733 001
CHLOR-TRIMETON
SCHERING
CHLORPHENIRAMINE MALEATE
2MG/5ML N006921 006
PHARM ASSOC
TABLET;ORAL
2MG/5ML A087520 001 Feb 10, 1982
ANTAGONATE
BAYER PHARMS 4MG A083381 001
CHLOR-TRIMETON
SCHERING 4MG N006921 002
CHLORPHENIRAMINE MALEATE
ANABOLIC 4MG A083078 001
BELL PHARMA 4MG A083062 001
ELKINS SINN 4MG A080938 001
IMPAX LABS 4MG A080809 001
IVAX SUB TEVA PHARMS 4MG A080779 001
KV PHARM 4MG A087164 001
LEDERLE 4MG A086941 001
MUTUAL PHARM 4MG A080700 001
NEWTRON PHARMS 4MG A086519 001
PANRAY 4MG A083243 001
PHARMAVITE 4MG A085104 001
PHARMERAL 4MG A083753 001
PIONEER PHARMS 4MG A088556 001 Jul 13, 1984
PUREPAC PHARM 4MG A086306 001
PVT FORM 4MG A080786 001
ROXANE 4MG A080626 001
SANDOZ 4MG A080961 001
VITARINE 4MG A085837 001
WATSON LABS 4MG A080696 001
4MG A080791 001
4MG A085139 001
WEST WARD 4MG A083787 001
KLOROMIN
HALSEY 4MG A083629 001
PHENETRON
LANNETT 4MG A080846 001
TABLET, EXTENDED RELEASE;ORAL
CHLOR-TRIMETON
SCHERING PLOUGH 8MG N007638 001
EFIDAC 24 CHLORPHENIRAMINE MALEATE
ALZA 16MG N019746 002 Nov 18, 1994
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-71( of 322)
CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
CHLOROHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE
WATSON LABS 12MG;75MG
CHLORPHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE
A088681 001 Sep 29, 1987
SANDOZ
COLD CAPSULE IV
12MG;75MG A088940 001 Jan 26, 1989
GRAHAM DM
COLD CAPSULE V
12MG;75MG N018793 001 Apr 25, 1985
GRAHAM DM
CONTAC 12 HOUR
8MG;75MG N018794 001 Apr 23, 1985
GLAXOSMITHKLINE
DRIZE
8MG;75MG N018099 001
ASCHER
ORNADE
12MG;75MG A088359 001 Feb 13, 1986
GLAXOSMITHKLINE 12MG;75MG
PHENYLPROPANOLAMINE HYDROCHLORIDE W/ CHLORPHENIRAMINE MALEATE
CENT PHARMS 8MG;75MG
TABLET, EXTENDED RELEASE;ORAL
CONTAC
N012152 004
N018809 001 May 07, 1984
NOVARTIS
DEMAZIN
12MG;75MG N019613 001 Jun 13, 1986
SCHERING PLOUGH
TRIAMINIC-12
4MG;25MG N018556 001 May 14, 1984
NOVARTIS 12MG;75MG N018115 001
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
CODIMAL-L.A. 12
SCHWARZ PHARMA
ISOCLOR
12MG;120MG N018935 001 Apr 15, 1985
FISONS 8MG;120MG
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
N018747 001 Mar 06, 1986
CENT PHARMS
GRAHAM DM
KV PHARM
8MG;120MG
8MG;120MG
12MG;120MG
12MG;120MG
N019428 001
N018844 001
N018843 001
A071455 001
Aug 02, 1988
Mar 20, 1985
Mar 18, 1985
Mar 01, 1989
CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX
SUSPENSION, EXTENDED RELEASE;ORAL
CODEPREX
UCB INC
PENNTUSS
EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML N021369 001 Jun 21, 2004
FISONS EQ 4MG MALEATE/5ML;EQ 10MG BASE/5ML N018928 001 Aug 14, 1985
CHLORPHENIRAMINE POLISTIREX; PHENYLPROPANOLAMINE POLISTIREX
SUSPENSION, EXTENDED RELEASE;ORAL
CORSYM
UCB INC EQ 4MG MALEATE/5ML;EQ 37.5MG HCL/5ML N018050 001 Jan 04, 1984
CHLORPHENTERMINE HYDROCHLORIDE
TABLET;ORAL
PRE-SATE
PARKE DAVIS EQ 65MG BASE N014696 001
CHLORPROMAZINE
SUPPOSITORY;RECTAL
THORAZINE
GLAXOSMITHKLINE 25MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N009149 024
100MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N009149 033
CHLORPROMAZINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
THORAZINE
GLAXOSMITHKLINE 30MG N011120 016
75MG N011120 017
150MG N011120 018
200MG N011120 019
300MG N011120 020
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-72( of 322)
CHLORPROMAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
CHLORPROMAZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 100MG/ML
PHARM ASSOC 30MG/ML
100MG/ML
WOCKHARDT 30MG/ML
100MG/ML
CHLORPROMAZINE HYDROCHLORIDE INTENSOL
A086863 001
A040231 001
A040224 001
A087032 001
A087053 001
Dec 30, 1999
Jan 26, 1999
Jul 08, 1982
ROXANE
SONAZINE
30MG/ML
100MG/ML
A088157 001
A088158 001
Apr 27, 1983
Apr 27, 1983
SANDOZ
THORAZINE
30MG/ML
100MG/ML
A080983 004
A080983 005
GLAXOSMITHKLINE 30MG/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
100MG/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
INJECTABLE;INJECTION
CHLORPROMAZINE HYDROCHLORIDE
N009149 032
N009149 043
ABRAXIS PHARM
MARSAM PHARMS LLC
WATSON LABS
WYETH AYERST
THORAZINE
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
A084911 001
A089563 001
A080365 001
A085591 001
A080370 001
Apr 15, 1988
GLAXOSMITHKLINE 25MG/ML
SYRUP;ORAL
CHLORPROMAZINE HYDROCHLORIDE
N009149 011
ALPHARMA US PHARMS
SONAZINE
10MG/5ML A086712 001
SANDOZ
THORAZINE
10MG/5ML A083040 001
GLAXOSMITHKLINE 10MG/5ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
CHLORPROMAZINE HYDROCHLORIDE
N009149 022
ABBOTT 10MG A084414 001
25MG A084415 001
50MG A084411 001
100MG A084412 001
200MG A084413 001
IVAX SUB TEVA PHARMS 10MG A083549 001
25MG A083549 002
50MG A083549 003
100MG A083574 001
200MG A083575 001
KV PHARM 10MG
25MG
A085750 002
A085751 001
Jan 04, 1982
50MG A085484 001
100MG A085752 001
LEDERLE
200MG
10MG
A085748 002
A084803 001
Jan 04, 1982
25MG A084801 001
50MG A084800 001
100MG A084789 001
200MG A084802 001
PUREPAC PHARM 10MG A080403 004
25MG A080403 001
50MG A080403 002
100MG A080403 003
200MG A080403 005
PVT FORM 25MG A080340 001
50MG A080340 002
200MG A080340 003
ROXANE 10MG A085331 001
25MG A085331 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CHLORPROMAZINE HYDROCHLORIDE
TABLET;ORAL
CHLORPROMAZINE HYDROCHLORIDE
50MG
100MG
200MG
VANGARD 10MG
25MG
50MG
WATSON LABS 10MG
25MG
50MG
100MG
200MG
WEST WARD 10MG
25MG
50MG
100MG
200MG
PROMAPAR
PARKE DAVIS 10MG
25MG
50MG
100MG
200MG
THORAZINE
GLAXOSMITHKLINE 10MG
25MG
50MG
100MG
200MG
CHLORPROPAMIDE
TABLET;ORAL
CHLORPROPAMIDE
BARR 100MG
100MG
250MG
250MG
CLONMEL HLTHCARE 100MG
250MG
DURAMED PHARMS BARR 100MG
250MG
HALSEY 100MG
250MG
IVAX PHARMS 100MG
250MG
PAR PHARM 100MG
250MG
SANDOZ 100MG
250MG
250MG
SUPERPHARM 100MG
250MG
TEVA 100MG
USL PHARMA 100MG
250MG
WATSON LABS 100MG
100MG
250MG
250MG
WATSON LABS INC 100MG
250MG
GLUCAMIDE
TEVA 250MG
CHLORPROTHIXENE
CONCENTRATE;ORAL
TARACTAN
ROCHE 100MG/5ML
INJECTABLE;INJECTION
TARACTAN
ROCHE 12.5MG/ML
6-73( of 322)
A085331 003
A085331 004
A085331 005
A088038 001 Aug 16, 1982
A087645 001
A087646 001
A085959 001
A085956 001
A085960 001
A085957 001
A085958 001
A087783 001 Sep 16, 1982
A087865 001 Sep 16, 1982
A087878 001 Sep 15, 1982
A087884 001 Sep 15, 1982
A087880 001 Sep 16, 1982
A086886 001
A084423 001
A086887 001
A086888 001
A086885 001
N009149 002
N009149 007
N009149 013
N009149 018
N009149 020
A088812 001 Oct 19, 1984
A089446 001 Nov 17, 1986
A088813 001 Oct 19, 1984
A089447 001 Nov 17, 1986
A089561 001 Sep 04, 1987
A089562 001 Sep 04, 1987
A088918 001 Oct 16, 1984
A088919 001 Oct 16, 1984
A089321 001 Jan 16, 1986
A088662 001 Jan 09, 1986
A088840 001 Oct 25, 1984
A087353 001
A088175 001 Feb 27, 1984
A088176 001 Feb 27, 1984
A088725 001 Aug 31, 1984
A084669 001
A088726 001 Aug 31, 1984
A088694 001 Sep 17, 1984
A088695 001 Sep 17, 1984
A088768 001 Oct 11, 1984
A088708 001 Aug 30, 1984
A088709 001 Aug 30, 1984
A086865 001 Sep 24, 1984
A088608 001 Apr 12, 1984
A086866 001
A088568 001 Apr 12, 1984
A088852 001 Sep 26, 1984
A088826 001 Sep 26, 1984
A088641 001 Oct 11, 1984
N016149 002
N012487 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CHLORPROTHIXENE
TABLET;ORAL
TARACTAN
ROCHE 10MG
25MG
50MG
100MG
CHLORTETRACYCLINE HYDROCHLORIDE
OINTMENT;OPHTHALMIC
AUREOMYCIN
LEDERLE 1%
CHLORTHALIDONE
TABLET;ORAL
CHLORTHALIDONE
ABBOTT 25MG
50MG
ASCOT 25MG
50MG
BARR LABS INC 25MG
50MG
DAVA PHARMS INC 25MG
50MG
IVAX PHARMS 25MG
25MG
50MG
50MG
KV PHARM 25MG
50MG
MUTUAL PHARM 25MG
25MG
25MG
50MG
50MG
50MG
PIONEER PHARMS 50MG
PUREPAC PHARM 25MG
50MG
SANDOZ 25MG
50MG
50MG
SUPERPHARM 25MG
50MG
TEVA 50MG
USL PHARMA 25MG
50MG
VANGARD 25MG
50MG
WARNER CHILCOTT 25MG
50MG
WATSON LABS 25MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG
HYGROTON
SANOFI AVENTIS US 25MG
50MG
THALITONE
CITRON PHARMA LLC 25MG
MONARCH PHARMS 25MG
CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE
TABLET;ORAL
CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
PAR PHARM 15MG;0.1MG
15MG;0.2MG
15MG;0.3MG
6-74( of 322)
N012486 005
N012486 004
N012486 003
N012486 001
N050404 001
A087364 001
A087384 001
A087698 001 Oct 20, 1982
A087699 001 Oct 20, 1982
A088902 001 Sep 19, 1985
A088903 001 Sep 19, 1985
A087451 001
A087450 001
A087555 001
A088164 001 Jan 09, 1984
A087176 001
A087947 001 Feb 27, 1984
A087311 001
A087312 001
A087292 001
A089285 001 Jul 21, 1986
A089738 001 Sep 19, 1988
A087293 001
A089286 001 Jul 21, 1986
A089739 001 Sep 19, 1988
A089591 001 Jul 21, 1988
A088139 001 Jul 16, 1986
A088140 001 Aug 11, 1983
A087380 001
A087118 001
A087381 001
A087473 001 Feb 09, 1983
A087247 001 Feb 09, 1983
A088651 001 May 30, 1985
A089051 001 Jun 01, 1987
A089052 001 Jun 01, 1987
A088012 001 Jul 14, 1982
A088073 001 Mar 25, 1983
A087515 001 Jan 24, 1983
A087516 001 Feb 09, 1983
A087050 001
A087100 001
A087296 001
A087706 001
A087029 001
A087082 001
A087521 001
A087689 001
N012283 004
N012283 003
N019574 002 Feb 12, 1992
A088051 001 Nov 12, 1982
A071179 001 Dec 16, 1987
A071178 001 Dec 16, 1987
A071142 001 Dec 16, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-75( of 322)
CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE
TABLET;ORAL
COMBIPRES
BOEHRINGER INGELHEIM 15MG;0.1MG
15MG;0.2MG
15MG;0.3MG
N017503 001
N017503 002
N017503 003 Apr 10, 1984
CHLORTHALIDONE; METOPROLOL TARTRATE
CAPSULE;ORAL
LOPRESSIDONE
NOVARTIS 25MG;100MG
25MG;200MG
N019451 001
N019451 002
Dec 31, 1987
Dec 31, 1987
CHLORTHALIDONE; RESERPINE
TABLET;ORAL
DEMI-REGROTON
SANOFI AVENTIS US
REGROTON
25MG;0.125MG N015103 002
SANOFI AVENTIS US 50MG;0.25MG N015103 001
CHLORZOXAZONE
TABLET;ORAL
CHLORZOXAZONE
ACTAVIS TOTOWA
MUTUAL PHARM
OHM LABS
PAR PHARM
PIONEER PHARMS
SANDOZ
WATSON LABS
250MG
500MG
500MG
250MG
500MG
250MG
250MG
500MG
250MG
500MG
250MG
A088928 001
A040113 001
A089970 001
A081298 001
A081299 001
A087981 001
A089592 001
A089948 001
A089852 001
A089853 001
A086901 001
May 08, 1987
Sep 29, 1995
Sep 27, 1990
Dec 29, 1993
Dec 29, 1993
Sep 20, 1983
Jan 06, 1989
Jan 06, 1989
May 04, 1988
May 04, 1988
PARAFLEX
250MG
500MG
A086948 001
A081019 001
Aug 09, 1982
Jul 29, 1991
ORTHO MCNEIL PHARM 250MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N011300 003
STRIFON FORTE DSC
FERNDALE LABS 500MG A081008 001 Dec 23, 1988
CHOLESTYRAMINE
BAR, CHEWABLE;ORAL
CHOLYBAR
PARKE DAVIS
POWDER;ORAL
CHOLESTYRAMINE
EQ 4GM RESIN/BAR
EQ 4GM RESIN/BAR
A071621 001
A071739 001
May 26, 1988
May 26, 1988
IVAX SUB TEVA PHARMS
TEVA
TEVA PHARMS
CHOLESTYRAMINE LIGHT
EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL
EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL
EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL
A074771 001
A074771 002
A074347 001
A074347 002
A074554 001
A074554 002
Jul 09, 1997
Jul 09, 1997
May 28, 1998
May 28, 1998
Oct 02, 1996
Oct 02, 1996
TEVA
TEVA PHARMS
LOCHOLEST
EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL
EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL
A074348 001
A074348 002
A074555 001
A074555 002
May 28, 1998
May 28, 1998
Sep 30, 1998
Sep 30, 1998
SANDOZ
LOCHOLEST LIGHT
EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL
A074561 001
A074561 002
Aug 15, 1996
Aug 15, 1996
SANDOZ
QUESTRAN
BRISTOL MYERS
QUESTRAN LIGHT
BRISTOL MYERS
EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL
EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL
EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL
A074562 001
A074562 002
N016640 001
N016640 003
N019669 001
N019669 003
Aug 15, 1996
Aug 15, 1996
Dec 05, 1988
Dec 05, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-76( of 322)
CHOLESTYRAMINE
TABLET;ORAL
QUESTRAN
APOTHECON EQ 1GM RESIN
EQ 800MG RESIN
A073403 001
A073403 002
Apr 28, 1994
Dec 27, 1999
CHORIOGONADOTROPIN ALFA
INJECTABLE;INJECTION
OVIDREL
EMD SERONO 0.25MG/VIAL N021149 001 Sep 20, 2000
CHROMIC CHLORIDE
INJECTABLE;INJECTION
CHROMIC CHLORIDE
ABRAXIS PHARM EQ 0.004MG CHROMIUM/ML N019271 001 May 05, 1987
CHROMIC PHOSPHATE P-32
INJECTABLE;INJECTION
PHOSPHOCOL P32
MALLINCKRODT 5mCi/ML N017084 001
CHYMOPAPAIN
INJECTABLE;INJECTION
CHYMODIACTIN
CHART MEDCL
DISCASE
4,000 UNITS/VIAL
10,000 UNITS/VIAL **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
N018663 002
N018663 001
Aug 21, 1984
Nov 10, 1982
ABBOTT 12,500 UNITS/VIAL N018625 001 Jan 18, 1984
CHYMOTRYPSIN
FOR SOLUTION;OPHTHALMIC
ALPHA CHYMAR
SOLA BARNES HIND
CATARASE
750 UNITS/VIAL N011837 001
CIBA
NOVARTIS
ZOLYSE
300 UNITS/VIAL
150 UNITS/VIAL
N016938 001
N018121 001
ALCON 750 UNITS/VIAL N011903 001
CICLOPIROX
SOLUTION;TOPICAL
CICLOPIROX
APOTEX INC
MYLAN PHARMS INC
TEVA PHARMS
8%
8%
8%
A078172 001
A078567 001
A078079 001
Sep 18, 2007
Sep 18, 2007
Sep 18, 2007
CILASTATIN SODIUM; IMIPENEM
INJECTABLE;INJECTION
PRIMAXIN
MERCK EQ 750MG BASE/VIAL;750MG/VIAL N050630 002 Dec 14, 1990
CILOSTAZOL
TABLET;ORAL
CILOSTAZOL
ACTAVIS TOTOWA
COREPHARMA
IVAX SUB TEVA PHARMS
MUTUAL PHARM
100MG
50MG
100MG
100MG
50MG
100MG
A077028 002
A077150 001
A077022 001
A077020 002
A077208 002
A077208 001
Nov 26, 2004
Mar 11, 2005
Nov 23, 2004
Mar 01, 2005
Mar 29, 2006
Mar 29, 2006
CIMETIDINE
SUSPENSION;ORAL
TAGAMET HB 200
GLAXOSMITHKLINE
TABLET;ORAL
CIMETIDINE
200MG/20ML N020951 001 Jul 09, 1999
IVAX SUB TEVA PHARMS
LEK PHARMS
200MG
300MG
400MG
800MG
100MG
200MG
200MG
A074401 001
A074401 002
A074401 003
A074402 001
A075122 001
A074250 001
A075122 002
May 30, 1995
May 30, 1995
May 30, 1995
May 30, 1995
Jun 19, 1998
Jun 29, 1995
Jun 19, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-77( of 322)
CIMETIDINE
TABLET;ORAL
CIMETIDINE
300MG A074250 002 Jun 29, 1995
400MG A074250 003 Jun 29, 1995
800MG A074250 004 Jun 29, 1995
PERRIGO 100MG A074972 001 Jun 19, 1998
ROXANE 300MG A074361 001 Dec 23, 1994
400MG A074361 002 Dec 23, 1994
800MG A074371 001 Dec 23, 1994
SANDOZ 200MG A074100 001 Jan 31, 1995
200MG A074506 001 Jan 24, 1996
300MG A074100 002 Jan 31, 1995
300MG A074506 002 Jan 24, 1996
400MG A074100 003 Jan 31, 1995
400MG A074506 003 Jan 24, 1996
800MG A074100 004 Jan 31, 1995
800MG A074506 004 Jan 24, 1996
TEVA 200MG A074365 001 Feb 28, 1995
300MG A074365 002 Feb 28, 1995
400MG A074365 003 Feb 28, 1995
800MG A074365 004 Feb 28, 1995
VINTAGE PHARMS LLC 200MG A074281 001 May 17, 1994
300MG A074281 002 May 17, 1994
400MG A074281 003 May 17, 1994
800MG A074329 001 May 17, 1994
WATSON LABS INC 200MG A074349 001 Aug 30, 1996
300MG A074349 002 Aug 30, 1996
400MG A074349 003 Aug 30, 1996
800MG A074316 001 Feb 28, 1996
TAGAMET HB
MEDTECH PRODS 100MG N020238 001 Jun 19, 1995
CIMETIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
CIMETIDINE HYDROCHLORIDE
HOSPIRA EQ 300MG BASE/2ML A074296 001 Mar 28, 1997
EQ 300MG BASE/2ML A074344 001 Jan 31, 1995
EQ 300MG BASE/2ML A074345 001 Jan 31, 1995
EQ 300MG BASE/2ML A074412 001 Mar 28, 1997
EQ 300MG BASE/2ML A074422 001 Jan 31, 1995
LUITPOLD EQ 300MG BASE/2ML A074353 001 Dec 20, 1994
TEVA PARENTERAL EQ 300MG BASE/2ML A074252 001 Nov 26, 1997
VINTAGE PHARMS LLC EQ 300MG BASE/2ML A074005 001 Aug 31, 1994
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA EQ 6MG BASE/ML A074269 001 Dec 27, 1994
EQ 90MG BASE/100ML A074468 005 Dec 29, 1994
EQ 120MG BASE/100ML A074468 006 Dec 29, 1994
EQ 180MG BASE/100ML A074468 003 Dec 29, 1994
EQ 240MG BASE/100ML A074468 004 Dec 29, 1994
EQ 360MG BASE/100ML A074468 001 Dec 29, 1994
EQ 480MG BASE/100ML A074468 002 Dec 29, 1994
TAGAMET
GLAXOSMITHKLINE EQ 300MG BASE/2ML N017939 002
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
GLAXOSMITHKLINE EQ 6MG BASE/ML N019434 001 Oct 31, 1985
SOLUTION;ORAL
CIMETIDINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC EQ 300MG BASE/5ML A074176 001 Jun 01, 1994
APOTEX INC EQ 300MG BASE/5ML A075560 001 Mar 15, 2000
DURAMED PHARMS BARR EQ 300MG BASE/5ML A075110 001 Jun 18, 1998
ROXANE EQ 300MG BASE/5ML A074541 001 Aug 05, 1997
TEVA PHARMS EQ 300MG BASE/5ML A074859 001 Jul 09, 1998
VINTAGE PHARMS LLC EQ 300MG BASE/5ML A074251 001 Dec 22, 1994
TAGAMET
GLAXOSMITHKLINE EQ 300MG BASE/5ML N017924 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-78( of 322)
CINOXACIN
CAPSULE;ORAL
CINOBAC
LILLY 250MG N018067 001
500MG N018067 002
CINOXACIN
TEVA 250MG
500MG
A073005 001
A073006 001
Feb 28, 1992
Feb 28, 1992
CIPROFLOXACIN
INJECTABLE;INJECTION
CIPRO
BAYER HLTHCARE 1200MG/120ML (10MG/ML)
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
N019847 003 Dec 26, 1990
BAYER PHARMS
CIPROFLOXACIN
200MG/100ML N019858 001 Dec 26, 1990
BEDFORD LABS 200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
1200MG/120ML (10MG/ML)
FRESENIUS KABI USA 200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
TEVA PHARMS USA 200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
CIPROFLOXACIN IN DEXTROSE 5%
A076992 001
A076992 002
A076993 001
A076484 001
A076484 002
A077782 001
A077782 002
Aug 28, 2006
Aug 28, 2006
Aug 28, 2006
Aug 28, 2006
Aug 28, 2006
Aug 28, 2006
Aug 28, 2006
HIKMA FARMACEUTICA 200MG/100ML
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
A076757 001 Apr 21, 2008
BAXTER HLTHCARE
BEDFORD
TEVA PHARMS
200MG/100ML
400MG/200ML
200MG/100ML
400MG/200ML
200MG/100ML
400MG/200ML
A077888 001
A077888 002
A078114 001
A078114 002
A077138 001
A077138 002
Mar 18, 2008
Mar 18, 2008
Mar 18, 2008
Mar 18, 2008
Mar 18, 2008
Mar 18, 2008
CIPROFLOXACIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CIPROFLOXACIN HYDROCHLORIDE
APOTEX INC EQ 0.3% BASE
TABLET;ORAL
CIPROFLOXACIN HYDROCHLORIDE
A075928 001 Jun 09, 2004
BARR EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
NOSTRUM LABS EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
PLIVA EQ 100MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
SANDOZ EQ 100MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 750MG BASE
EQ 750MG BASE
TEVA EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
TABLET, EXTENDED RELEASE;ORAL
PROQUIN XR
DEPOMED INC EQ 500MG BASE
A074124 001
A074124 002
A074124 003
A076138 001
A076138 002
A076138 003
A076426 001
A076426 002
A076426 003
A076426 004
A075939 001
A075939 002
A076593 002
A075939 003
A076593 003
A075939 004
A076593 004
A076136 001
A076136 002
A076136 003
N021744 001
Jun 09, 2004
Jun 09, 2004
Jun 09, 2004
Jun 09, 2004
Jun 09, 2004
Jun 09, 2004
Jun 15, 2005
Jun 15, 2005
Jun 15, 2005
Jun 15, 2005
Mar 03, 2005
Jun 09, 2004
Jun 09, 2004
Jun 09, 2004
Jun 09, 2004
Jun 09, 2004
Jun 09, 2004
Jun 09, 2004
Jun 09, 2004
Jun 09, 2004
May 19, 2005
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CIPRO XR
BAYER HLTHCARE 212.6MG;EQ 287.5MG BASE
425.2MG;EQ 574.9MG BASE
CIPROFLOXACIN EXTENDED RELEASE
N021473 001
N021473 002
Dec 13, 2002
Aug 28, 2003
DR REDDYS LABS LTD
SANDOZ
212.6MG;EQ 287.5MG BASE
212.6MG;EQ 287.5MG BASE
A077701 002
A078712 001
Oct 31, 2007
Dec 11, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-79( of 322)
CISAPRIDE MONOHYDRATE
SUSPENSION;ORAL
PROPULSID
JANSSEN PHARMS
TABLET;ORAL
PROPULSID
EQ 1MG BASE/ML N020398 001 Sep 15, 1995
JANSSEN PHARMS EQ 10MG BASE
EQ 20MG BASE
TABLET, ORALLY DISINTEGRATING;ORAL
PROPULSID QUICKSOLV
JANSSEN PHARMA EQ 20MG BASE
N020210 001
N020210 002
N020767 001
Jul 29, 1993
Dec 23, 1993
Nov 07, 1997
CISPLATIN
INJECTABLE;INJECTION
CISPLATIN
BEDFORD
TEVA PHARMS USA
PLATINOL
10MG/VIAL
50MG/VIAL
1MG/ML
A074713 001
A074713 002
A074814 001
Nov 14, 2000
Nov 14, 2000
May 16, 2000
HQ SPCLT PHARMA
PLATINOL-AQ
HQ SPCLT PHARMA
10MG/VIAL
50MG/VIAL
0.5MG/ML
N018057 001
N018057 002
N018057 003 Jul 18, 1984
CITALOPRAM HYDROBROMIDE
SOLUTION;ORAL
CELEXA
FOREST LABS
CITALOPRAM HYDROBROMIDE
EQ 10MG BASE/5ML N021046 001 Dec 22, 1999
APOTEX INC
TABLET;ORAL
CELEXA
EQ 10MG BASE/5ML A077601 001 Nov 15, 2005
FOREST LABS
CITALOPRAM HYDROBROMIDE
EQ 60MG BASE N020822 004 Jul 17, 1998
ACTAVIS ELIZABETH EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
COREPHARMA EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
MUTUAL PHARM EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
NATCO PHARMA LTD EQ 20MG BASE
EQ 40MG BASE
ROXANE EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
SANDOZ EQ 10MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 40MG BASE
TARO EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
TEVA PHARMS EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
TABLET, ORALLY DISINTEGRATING;ORAL
CITALOPRAM HYDROBROMIDE
A077033 001
A077033 002
A077033 003
A077036 001
A077036 002
A077036 003
A077052 001
A077052 002
A077052 003
A077141 002
A077141 001
A077041 001
A077041 002
A077041 003
A077035 001
A077040 001
A077035 002
A077040 002
A077035 003
A077040 003
A077278 001
A077278 002
A077278 003
A077213 001
A077213 002
A077213 003
Oct 28, 2004
Oct 28, 2004
Oct 28, 2004
Oct 28, 2004
Oct 28, 2004
Oct 28, 2004
Jul 03, 2006
Jul 03, 2006
Jul 03, 2006
Apr 10, 2008
Apr 10, 2008
Nov 23, 2004
Nov 23, 2004
Nov 23, 2004
Oct 28, 2004
Aug 17, 2005
Oct 28, 2004
Aug 17, 2005
Oct 28, 2004
Aug 17, 2005
Mar 22, 2006
Mar 22, 2006
Mar 22, 2006
Mar 31, 2006
Mar 31, 2006
Mar 31, 2006
BIOVAIL LABS INTL EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
N021763 001
N021763 002
N021763 003
Dec 20, 2005
Dec 20, 2005
Dec 20, 2005
CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE
SOLUTION;IRRIGATION
IRRIGATING SOLUTION G IN PLASTIC CONTAINER
BAXTER HLTHCARE 3.24GM/100ML;380MG/100ML;430MG/100ML
UROLOGIC G IN PLASTIC CONTAINER
N018519 001 Jun 22, 1982
HOSPIRA 3.24GM/100ML;380MG/100ML;430MG/100ML N018904 001 May 27, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
CLADRIBINE
INJECTABLE;INJECTION
LEUSTATIN
JANSSEN PHARMS
CLARITHROMYCIN
FOR SUSPENSION;ORAL
BIAXIN
ABBVIE
TABLET;ORAL
CLARITHROMYCIN
IVAX SUB TEVA PHARMS
TABLET, EXTENDED RELEASE;ORAL
CLARITHROMYCIN
RANBAXY
SANDOZ
CLEMASTINE FUMARATE
SYRUP;ORAL
CLEMASTINE FUMARATE
ACTAVIS MID ATLANTIC
APOTEX INC
SILARX
TEVA PHARMS
TAVIST
NOVARTIS
TABLET;ORAL
CLEMASTINE FUMARATE
TEVA
TAVIST
NOVARTIS
TAVIST-1
NOVARTIS
1MG/ML
187MG/5ML
250MG
500MG
1GM
500MG
EQ 0.5MG BASE/5ML
EQ 0.5MG BASE/5ML
EQ 0.5MG BASE/5ML
EQ 0.5MG BASE/5ML
EQ 0.5MG BASE/5ML
1.34MG
1.34MG
2.68MG
1.34MG
1.34MG
CLEMASTINE FUMARATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
TAVIST-D
NOVARTIS
CLIDINIUM BROMIDE
CAPSULE;ORAL
QUARZAN
ROCHE
CLINDAMYCIN HYDROCHLORIDE
CAPSULE;ORAL
CLEOCIN
PHARMACIA AND UPJOHN
CLINDAMYCIN HYDROCHLORIDE
TEVA
WATSON LABS
EQ 1MG BASE;75MG
1.34MG;75MG
1.34MG;75MG
2.5MG
5MG
EQ 75MG BASE
EQ 150MG BASE
EQ 75MG BASE
EQ 75MG BASE
CLINDAMYCIN PALMITATE HYDROCHLORIDE
FOR SOLUTION;ORAL
CLEOCIN
PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE
CREAM;VAGINAL
CLEOCIN
PHARMACIA AND UPJOHN
INJECTABLE;INJECTION
CLEOCIN PHOSPHATE
PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE
ABRAXIS PHARM
ASTRAZENECA
BEDFORD
BRISTOL MYERS SQUIBB
EQ 75MG BASE/5ML
EQ 2% BASE
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
6-80( of 322)
N020229 001 Feb 26, 1993
N050698 003 Sep 30, 1998
A065137 001 May 31, 2005
A065137 002 May 31, 2005
A065210 001 Jan 26, 2005
A065250 001 Aug 25, 2005
A074075 001 Oct 31, 1993
A075703 001 Nov 27, 2000
A074884 001 Dec 17, 1997
A073095 001 Apr 21, 1992
N018675 001 Jun 28, 1985
A073282 001 Jan 31, 1992
A073282 002 Dec 03, 1992
N017661 001
N017661 002
N017661 003 Aug 21, 1992
N018298 001 Dec 15, 1982
N018298 002 Aug 21, 1992
N020640 001 Aug 09, 1996
N010355 001
N010355 002
A061809 001
A061809 002
A063027 001 Sep 20, 1989
A063082 001 Jul 31, 1991
A061827 001
N050680 001 Aug 11, 1992
A061839 001
A062747 001 Jun 03, 1988
A062928 001 Feb 13, 1989
A063163 001 Jun 30, 1994
A062908 001 Feb 01, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-81( of 322)
CLINDAMYCIN PHOSPHATE
INJECTABLE;INJECTION
CLINDAMYCIN PHOSPHATE
HIKMA MAPLE EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
LOCH EQ 150MG BASE/ML
MARSAM PHARMS LLC EQ 150MG BASE/ML
SOLOPAK EQ 150MG BASE/ML
EQ 150MG BASE/ML
TEVA PARENTERAL EQ 150MG BASE/ML
EQ 150MG BASE/ML
WATSON LABS EQ 150MG BASE/ML
EQ 150MG BASE/ML
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
A062806 001
A062953 001
A063068 001
A062905 001
A062913 001
A062819 001
A062852 001
A063041 001
A063282 001
A062900 001
A063079 001
Oct 15, 1987
Apr 21, 1988
Aug 28, 1989
May 09, 1988
Oct 20, 1988
Mar 15, 1988
Mar 17, 1988
Dec 29, 1989
May 29, 1992
Jun 08, 1988
Mar 05, 1990
ABRAXIS PHARM EQ 12MG BASE/ML
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
N050636 001 Dec 22, 1989
ABBVIE
BAXTER HLTHCARE
SOLUTION;TOPICAL
CLEOCIN T
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 18MG BASE/ML
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 900MG BASE/100ML
A065027 001
A065027 002
A065027 003
N050648 001
N050648 002
N050648 003
Jun 29, 2001
Jun 29, 2001
Jun 29, 2001
Dec 29, 1989
Dec 29, 1989
Dec 29, 1989
PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE
EQ 1% BASE A062363 001 Feb 08, 1982
ACTAVIS MID ATLANTIC
BOCA PHARMA LLC
COPLEY PHARM
RENAISSANCE PHARMA
EQ 1% BASE
EQ 1% BASE
EQ 1% BASE
EQ 1% BASE
A062811 001
A062930 001
A062944 001
A064108 001
Sep 01, 1988
Jun 28, 1989
Jan 11, 1989
Sep 27, 1996
CLIOQUINOL; NYSTATIN
OINTMENT;TOPICAL
NYSTAFORM
BAYER PHARMS 10MG/GM;100,000 UNITS/GM N050235 001
CLOBAZAM
TABLET;ORAL
ONFI
LUNDBECK LLC 5MG N202067 001 Oct 21, 2011
CLOBETASOL PROPIONATE
CREAM;TOPICAL
CLOBETASOL PROPIONATE
G AND W LABS INC 0.05%
RENAISSANCE PHARMA 0.05%
TEVA PHARMS USA 0.05%
CLOBETASOL PROPIONATE (EMOLLIENT)
RENAISSANCE PHARMA 0.05%
OINTMENT;TOPICAL
CLOBETASOL PROPIONATE
A074139 001
A075338 001
A074087 001
A075733 001
Aug 03, 1994
Feb 09, 2001
Feb 16, 1994
Aug 22, 2001
ACTAVIS MID ATLANTIC
RENAISSANCE PHARMA
SOLUTION;TOPICAL
CLOBETASOL PROPIONATE
0.05%
0.05%
A074128 001
A075057 001
Aug 03, 1994
Aug 12, 1998
G AND W LABS INC
TEMOVATE
0.05% A074331 001 Dec 15, 1995
FOUGERA PHARMS 0.05% N019966 001 Feb 22, 1990
CLOFAZIMINE
CAPSULE;ORAL
LAMPRENE
NOVARTIS 100MG N019500 001 Dec 15, 1986
CLOFIBRATE
CAPSULE;ORAL
ATROMID-S
WYETH AYERST 500MG N016099 002
CLOFIBRATE
BANNER PHARMACAPS
SANDOZ
TEVA
USL PHARMA
WATSON LABS
500MG
500MG
500MG
500MG
500MG
A073396 001
A072191 001
A072600 001
A070531 001
A071603 001
Mar 20, 1992
May 02, 1988
Jul 25, 1991
Jun 16, 1986
Sep 18, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-82( of 322)
CLOMIPHENE CITRATE
TABLET;ORAL
MILOPHENE
MILEX 50MG A072196 001 Dec 20, 1988
CLOMIPRAMINE HYDROCHLORIDE
CAPSULE;ORAL
CLOMIPRAMINE HYDROCHLORIDE
SANDOZ
TEVA
WATSON LABS
25MG
50MG
75MG
25MG
50MG
75MG
25MG
25MG
50MG
50MG
75MG
75MG
A074953 001
A074953 002
A074953 003
A074849 001
A074849 002
A074849 003
A074600 001
A074751 001
A074600 002
A074751 002
A074600 003
A074751 003
Jun 25, 1997
Jun 25, 1997
Jun 25, 1997
Apr 04, 1997
Apr 04, 1997
Apr 04, 1997
Nov 27, 1996
Sep 30, 1998
Nov 27, 1996
Sep 30, 1998
Nov 27, 1996
Sep 30, 1998
CLONAZEPAM
TABLET;ORAL
CLONAZEPAM
APOTEX INC
SANDOZ
TEVA
KLONOPIN
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
A075468 001
A075468 002
A075468 003
A074925 001
A074925 002
A074925 003
A074920 001
A074920 002
A074920 003
Oct 06, 2000
Oct 06, 2000
Oct 06, 2000
Sep 30, 1997
Sep 30, 1997
Sep 30, 1997
Aug 04, 1998
Aug 04, 1998
Aug 04, 1998
ROCHE 0.125MG
0.25MG
TABLET, ORALLY DISINTEGRATING;ORAL
KLONOPIN RAPIDLY DISINTEGRATING
N017533 005
N017533 006
Apr 09, 1997
Apr 09, 1997
ROCHE 0.125MG
0.25MG
0.5MG
1MG
2MG
N020813 001
N020813 002
N020813 003
N020813 004
N020813 005
Dec 23, 1997
Dec 23, 1997
Dec 23, 1997
Dec 23, 1997
Dec 23, 1997
CLONIDINE
SUSPENSION, EXTENDED RELEASE;ORAL
CLONIDINE
TRIS PHARMA INC EQ 0.09MG BASE/ML
TABLET, EXTENDED RELEASE;ORAL
CLONIDINE
N022499 001 Dec 03, 2009
TRIS PHARMA INC EQ 0.17MG BASE
EQ 0.26MG BASE
N022500 001
N022500 002
Dec 03, 2009
Dec 03, 2009
CLONIDINE HYDROCHLORIDE
TABLET;ORAL
CLONIDINE HYDROCHLORIDE
AM THERAP
DURAMED PHARMS BARR
INTERPHARM
PAR PHARM
SANDOZ
TEVA
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
A070881 001
A070882 001
A070883 001
A071103 001
A071102 001
A071101 001
A071252 001
A071253 001
A071254 001
A070461 001
A070460 001
A070459 001
A070887 001
A070886 001
A071294 001
A070747 001
A070702 001
A070659 001
Jul 08, 1986
Jul 08, 1986
Jul 08, 1986
Aug 14, 1986
Aug 14, 1986
Aug 14, 1986
Oct 01, 1986
Oct 01, 1986
Oct 01, 1986
Jul 08, 1986
Jul 08, 1986
Jul 08, 1986
Aug 31, 1988
Aug 31, 1988
Aug 31, 1988
Jul 08, 1986
Jul 08, 1986
Jul 08, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-83( of 322)
CLONIDINE HYDROCHLORIDE
TABLET;ORAL
CLONIDINE HYDROCHLORIDE
WARNER CHILCOTT
WATSON LABS
TABLET, EXTENDED RELEASE;ORAL
JENLOGA
CONCORDIA PHARMS INC
CLORAZEPATE DIPOTASSIUM
CAPSULE;ORAL
CLORAZEPATE DIPOTASSIUM
ABLE
AM THERAP
CLONMEL HLTHCARE
GD SEARLE LLC
MYLAN
PUREPAC PHARM
QUANTUM PHARMICS
SANDOZ
USL PHARMA
WARNER CHILCOTT
WATSON LABS
TRANXENE
RECORDATI RARE
TABLET;ORAL
CLORAZEPATE DIPOTASSIUM
ABLE
AM THERAP
LEDERLE
PUREPAC PHARM
QUANTUM PHARMICS
0.1MG
0.2MG
0.3MG
0.1MG
0.1MG
0.2MG
0.2MG
0.3MG
0.1MG
0.2MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
A072138 001 Jun 13, 1988
A072139 001 Jun 13, 1988
A072140 001 Jun 13, 1988
A070395 001 Mar 23, 1987
A070965 001 Jul 08, 1986
A070396 001 Mar 23, 1987
A070964 001 Jul 08, 1986
A070397 001 Mar 23, 1987
N022331 001 Sep 30, 2009
N022331 002 May 25, 2010
A071777 001 Jul 14, 1987
A071778 001 Jul 14, 1987
A071779 001 Jul 14, 1987
A071429 001 Jun 23, 1987
A071430 001 Jun 23, 1987
A071431 001 Jun 23, 1987
A071742 001 Dec 14, 1987
A071743 001 Dec 14, 1987
A071744 001 Dec 14, 1987
A071727 001 Dec 18, 1987
A071728 001 Dec 18, 1987
A071729 001 Dec 18, 1987
A071509 001 Oct 19, 1987
A071510 001 Oct 19, 1987
A071511 001 Oct 19, 1987
A071924 001 Apr 25, 1988
A071925 001 Apr 25, 1988
A071926 001 Apr 25, 1988
A071549 001 Sep 12, 1988
A071550 001 Sep 12, 1988
A071522 001 Sep 12, 1988
A072219 001 Aug 26, 1988
A072220 001 Aug 26, 1988
A072112 001 Aug 26, 1988
A071242 001 Jun 23, 1987
A071243 001 Jun 23, 1987
A071244 001 Jun 23, 1987
A071774 001 Mar 01, 1988
A071775 001 Mar 01, 1988
A071776 001 Mar 01, 1988
A071878 001 Mar 15, 1988
A071879 001 Mar 15, 1988
A071860 001 Mar 15, 1988
N017105 001
N017105 002
N017105 003
A071780 001 Jun 26, 1987
A071781 001 Jun 26, 1987
A071782 001 Jun 26, 1987
A071747 001 Jun 23, 1987
A071748 001 Jun 23, 1987
A071749 001 Jun 23, 1987
A072013 001 Dec 15, 1987
A072014 001 Dec 15, 1987
A072015 001 Dec 15, 1987
A072330 001 Aug 08, 1988
A072331 001 Aug 08, 1988
A072332 001 Aug 08, 1988
A071730 001 Oct 26, 1987
A071731 001 Oct 26, 1987
A071702 001 Oct 26, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-84( of 322)
CLORAZEPATE DIPOTASSIUM
TABLET;ORAL
CLORAZEPATE DIPOTASSIUM
SANDOZ
WARNER CHILCOTT
TRANXENE SD
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
A072512 001
A072513 001
A072514 001
A071828 001
A071829 001
A071830 001
May 11, 1990
May 11, 1990
May 11, 1990
Mar 03, 1988
Mar 03, 1988
Mar 03, 1988
RECORDATI RARE 11.25MG N017105 005
22.5MG N017105 004
CLOTRIMAZOLE
CREAM;TOPICAL
LOTRIMIN
SCHERING PLOUGH 1% N017619 001
MYCELEX
BAYER 1% N018183 001
LOTION;TOPICAL
LOTRIMIN
SCHERING
SOLUTION;TOPICAL
LOTRIMIN
1% N018813 001 Feb 17, 1984
SCHERING PLOUGH 1% N017613 001
MYCELEX
BAYER HLTHCARE 1% **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N018181 001
TABLET;VAGINAL
GYNIX
TEVA PHARMS
MYCELEX-G
100MG A073249 001 Feb 13, 1998
BAYER PHARMS
TROCHE/LOZENGE;ORAL
MYCELEX
500MG N019069 001 Apr 19, 1985
BAYER HLTHCARE 10MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N018713 001 Jun 17, 1983
CLOXACILLIN SODIUM
CAPSULE;ORAL
CLOXACILLIN SODIUM
APOTHECON
TEVA
CLOXAPEN
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
A061452 001
A061452 002
A062240 001
A062240 002
GLAXOSMITHKLINE
FOR SOLUTION;ORAL
CLOXACILLIN SODIUM
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
A061806 001
A062233 001
A061806 002
A062233 002
TEVA
TEGOPEN
EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
A062268 001
A062978 001 Apr 06, 1989
APOTHECON EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
A061453 001
N050192 001
CLOZAPINE
TABLET;ORAL
CLOZAPINE
PAR PHARM 25MG
100MG
SANDOZ 25MG
100MG
TABLET, ORALLY DISINTEGRATING;ORAL
FAZACLO ODT
A075162 001
A075162 002
A074546 001
A074546 002
Apr 26, 2005
Apr 26, 2005
Aug 30, 1996
Aug 30, 1996
JAZZ PHARMS III 50MG N021590 003 Jun 03, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-85( of 322)
COBALT CHLORIDE CO-57; CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR
N/A;N/A
RUBRATOPE-57 KIT
BRACCO N/A;N/A;N/A;N/A N016089 001
COBALT CHLORIDE CO-60; CYANOCOBALAMIN; CYANOCOBALAMIN CO-60; INTRINSIC FACTOR
N/A;N/A
RUBRATOPE-60 KIT
BRACCO N/A;N/A;N/A;N/A N016090 001
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PHENERGAN VC W/ CODEINE
ANI PHARMS 10MG/5ML;5MG/5ML;6.25MG/5ML N008306 005 Apr 02, 1984
PHERAZINE VC W/ CODEINE
HALSEY 10MG/5ML;5MG/5ML;6.25MG/5ML A088870 001 Mar 02, 1987
PROMETHAZINE VC W/ CODEINE
CENCI 10MG/5ML;5MG/5ML;6.25MG/5ML A088816 001 Nov 22, 1985
WOCKHARDT 10MG/5ML;5MG/5ML;6.25MG/5ML A088896 001 Jan 04, 1985
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PHENERGAN W/ CODEINE
ANI PHARMS 10MG/5ML;6.25MG/5ML N008306 004 Apr 02, 1984
PHERAZINE W/ CODEINE
HALSEY 10MG/5ML;6.25MG/5ML A088739 001 Dec 23, 1988
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
PHARM ASSOC 10MG/5ML;6.25MG/5ML A089647 001 Dec 22, 1988
PROMETHAZINE W/ CODEINE
CENCI 10MG/5ML;6.25MG/5ML A088814 001 Nov 22, 1985
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
SYRUP;ORAL
ACTIFED W/ CODEINE
GLAXOSMITHKLINE 10MG/5ML;30MG/5ML;1.25MG/5ML N012575 003 Apr 04, 1984
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE
CENCI 10MG/5ML;30MG/5ML;1.25MG/5ML A089018 001 Jul 23, 1986
TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL AND CODEINE PHOSPHATE
WOCKHARDT 10MG/5ML;30MG/5ML;1.25MG/5ML A088833 001 Nov 16, 1984
COLCHICINE; PROBENECID
TABLET;ORAL
COLBENEMID
MERCK 0.5MG;500MG N012383 001
PROBEN-C
WATSON LABS 0.5MG;500MG A085552 001
PROBENECID AND COLCHICINE
BEECHAM 0.5MG;500MG A084321 001
IMPAX LABS 0.5MG;500MG A083720 002
IVAX SUB TEVA PHARMS 0.5MG;500MG A083734 001
SANDOZ 0.5MG;500MG A086130 001
PROBENECID W/ COLCHICINE
LEDERLE 0.5MG;500MG A086954 001
WATSON LABS 0.5MG;500MG A083221 001
COLESEVELAM HYDROCHLORIDE
CAPSULE;ORAL
WELCHOL
DAIICHI SANKYO 375MG N021141 001 May 26, 2000
COLISTIN SULFATE
SUSPENSION;ORAL
COLY-MYCIN S
PARKE DAVIS EQ 25MG BASE/5ML N050355 001
CONIVAPTAN HYDROCHLORIDE
INJECTABLE;IV (INFUSION)
VAPRISOL
ASTELLAS 20MG/4ML (5MG/ML) N021697 001 Dec 29, 2005
COPPER
INTRAUTERINE DEVICE;INTRAUTERINE
CU-7
GD SEARLE LLC 89MG N017408 001
TATUM-T
GD SEARLE LLC 120MG N018205 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-86( of 322)
CORTICOTROPIN
INJECTABLE;INJECTION
ACTH
PARKEDALE
ACTHAR
SANOFI AVENTIS US
CORTICOTROPIN
ORGANICS LAGRANGE
WATSON LABS
H.P. ACTHAR GEL
QUESTCOR PHARMS
PURIFIED CORTROPHIN GEL
ORGANON USA INC
CORTICOTROPIN-ZINC HYDROXIDE
INJECTABLE;INJECTION
CORTROPHIN-ZINC
ORGANON USA INC
CORTISONE ACETATE
INJECTABLE;INJECTION
CORTISONE ACETATE
PHARMACIA AND UPJOHN
WATSON LABS
CORTONE
MERCK
TABLET;ORAL
CORTISONE ACETATE
BARR
ELKINS SINN
EVERYLIFE
HEATHER
IMPAX LABS
INWOOD LABS
IVAX SUB TEVA PHARMS
LANNETT
PANRAY
PHARMACIA AND UPJOHN
PUREPAC PHARM
VITARINE
WATSON LABS
WHITEWORTH TOWN PLSN
CORTONE
MERCK
25 UNITS/VIAL
40 UNITS/VIAL
25 UNITS/VIAL
40 UNITS/VIAL
40 UNITS/ML
80 UNITS/ML
40 UNITS/VIAL
40 UNITS/ML
40 UNITS/ML
80 UNITS/ML
40 UNITS/ML
25MG/ML
25MG/ML
25MG/ML
50MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
5MG
25MG
5MG
10MG
25MG
25MG
25MG
25MG
25MG
25MG
N008317 002
N008317 004
N007504 002
N007504 003
N010831 001
N010831 002
A088772 001
N008372 006
N008975 001
N008975 002
N009854 001
N008126 002
A083147 003
A085677 001
A083147 004
A085677 002
N007110 002
N007110 003
A083471 001
A080836 001
A084246 001
A085736 001
N009458 001
A080731 001
A080630 001
A083536 001
A080694 001
N008284 002
N008284 001
N008126 003
N008126 004
N008126 001
A080493 001
A080333 001
A085884 001
A080341 001
N007750 003
Nov 21, 1984
CROMOLYN SODIUM
AEROSOL, METERED;INHALATION
INTAL
KING PFIZER
CAPSULE;INHALATION
INTAL
SANOFI AVENTIS US
CAPSULE;ORAL
GASTROCROM
UCB INC
CONCENTRATE;ORAL
CROMOLYN SODIUM
GENERA PHARMS
0.8MG/INH
20MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
100MG
100MG/5ML
N018887 001
N016990 001
N019188 001
A090954 001
Dec 05, 1985
Dec 22, 1989
Dec 18, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-87( of 322)
CROMOLYN SODIUM
SOLUTION;INHALATION
CROMOLYN SODIUM
ACTAVIS MID ATLANTIC
APOTEX INC
PHARMASCIENCE INC
ROXANE
INTAL
10MG/ML
10MG/ML
10MG/ML
10MG/ML
A075067 001
A075333 001
A075437 001
A075175 001
Jul 19, 1999
Apr 30, 2002
Apr 21, 2000
Sep 30, 1999
KING PHARMS
SOLUTION/DROPS;OPHTHALMIC
CROMOLYN SODIUM
10MG/ML N018596 001 May 28, 1982
APOTEX INC
CROMOPTIC
4% A075615 001 Jan 26, 2001
KING PHARMS
SPRAY, METERED;NASAL
CROMOLYN SODIUM
4% A075088 001 Apr 27, 1999
ACTAVIS MID ATLANTIC
HH AND P
NASALCROM
5.2MG/SPRAY
5.2MG/SPRAY
A074800 001
A077976 001
Jul 26, 2001
Sep 07, 2007
BLACKSMITH BRANDS 5.2MG/SPRAY **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
N020463 001 Jan 03, 1997
CRYPTENAMINE ACETATES
INJECTABLE;INJECTION
UNITENSEN
MEDPOINTE PHARM HLC 260CSR UNIT/ML N008814 001
CRYPTENAMINE TANNATES
TABLET;ORAL
UNITENSEN
MEDPOINTE PHARM HLC 260CSR UNIT N009217 001
CUPRIC SULFATE
INJECTABLE;INJECTION
CUPRIC SULFATE
ABRAXIS PHARM EQ 0.4MG COPPER/ML N019350 001 May 05, 1987
CYANOCOBALAMIN
GEL, METERED;NASAL
NASCOBAL
PAR PHARM
INJECTABLE;INJECTION
BERUBIGEN
0.5MG/INH N019722 001 Nov 05, 1996
PHARMACIA AND UPJOHN
BETALIN 12
1MG/ML N006798 001
LILLY
COBAVITE
0.1MG/ML
1MG/ML
A080855 001
A080855 002
WATSON LABS
CYANOCOBALAMIN
0.1MG/ML
1MG/ML
A083013 001
A083064 001
ABRAXIS PHARM
AKORN
DELL LABS
FRESENIUS KABI USA
HIKMA MAPLE
LUITPOLD
LYPHOMED
MYLAN INSTITUTIONAL
SANOFI AVENTIS US
SOLOPAK
WARNER CHILCOTT
WATSON LABS
WYETH AYERST
0.03MG/ML
0.1MG/ML
1MG/ML
1MG/ML
0.03MG/ML
0.1MG/ML
1MG/ML
0.1MG/ML
1MG/ML
0.03MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
0.1MG/ML
0.1MG/ML
1MG/ML
1MG/ML
0.1MG/ML
1MG/ML
A080510 003
A080510 001
A080510 002
A087969 001
A080689 001
A080689 002
A080689 003
A080557 002
A080515 002
A080668 001
A083075 001
A040451 001
A080564 001
A087551 001
N007085 002
A080573 002
A083120 001
A080573 001
A083120 002
A080554 001
A080554 002
Nov 10, 1983
Sep 23, 2003
Feb 29, 1984
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-88( of 322)
N006668 010
N010791 004
N010791 001
N010791 002
N010791 005
N010791 003
N006799 002
N006799 004
N006799 010 Apr 28, 1988
A080570 002
N007012 002
N022102 001 Jul 27, 2007
A084264 001
N016089 002
N016090 002
N017406 001
N016635 001
N011208 001
N050508 001
N050508 002
N050508 003
A062895 001 Aug 04, 1988
A062895 002 Aug 04, 1988
N050509 001
N050509 002
N009495 001
A077291 001 Feb 03, 2006
A072854 002 Feb 03, 2006
A072854 001 Nov 19, 1991
A073683 001 Feb 26, 1993
CYANOCOBALAMIN
INJECTABLE;INJECTION
REDISOL
MERCK
RUBIVITE
BEL MAR
RUBRAMIN PC
BRISTOL MYERS SQUIBB
RUVITE
SAVAGE LABS
VI-TWEL
BAYER HLTHCARE
SPRAY, METERED;NASAL
CALOMIST
PAR PHARM
TABLET;ORAL
CYANOCOBALAMIN
WEST WARD
CYANOCOBALAMIN CO-57
CAPSULE;ORAL
RUBRATOPE-57
BRACCO
CYANOCOBALAMIN CO-60
CAPSULE;ORAL
RUBRATOPE-60
BRACCO
1MG/ML
0.03MG/ML
0.05MG/ML
0.1MG/ML
0.12MG/ML
1MG/ML
0.1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
25MCG/SPRAY
1MG
0.5-1uCi
0.5-1uCi
INJECTABLE;INJECTION
DEPINAR
ARMOUR PHARM
CYCLACILLIN
FOR SUSPENSION;ORAL
CYCLAPEN-W
WYETH AYERST
TABLET;ORAL
CYCLACILLIN
TEVA
CYCLAPEN-W
WYETH AYERST
CYCLIZINE LACTATE
INJECTABLE;INJECTION
MAREZINE
GLAXOSMITHKLINE
CYCLOBENZAPRINE HYDROCHLORIDE
TABLET;ORAL
CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58
N/A;N/A
DICOPAC KIT
GE HEALTHCARE N/A;N/A;N/A
CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR
N/A;N/A
CYANOCOBALAMIN CO 57 SCHILLING TEST KIT
MALLINCKRODT 0.1MG;0.5uCi;60MG
CYANOCOBALAMIN; TANNIC ACID; ZINC ACETATE
0.5MG/ML;2.3MG/ML;1MG/ML
125MG/5ML
250MG/5ML
500MG/5ML
250MG
500MG
250MG
500MG
50MG/ML
CYCLOBENZAPRINE HYDROCHLORIDE
PROSAM LABS 5MG
SANDOZ 5MG
10MG
10MG
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-89( of 322)
CYCLOBENZAPRINE HYDROCHLORIDE
TABLET;ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
WATSON LABS
FLEXERIL
10MG
10MG
A073143 001
A074436 001
Nov 27, 1991
Nov 30, 1994
JANSSEN RES AND DEV 5MG N017821 001
10MG N017821 002
CYCLOPENTOLATE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AK-PENTOLATE
AKORN 1% A085555 001
AKPENTOLATE
AKORN 2%
CYCLOPENTOLATE HYDROCHLORIDE
A040165 001 Jan 13, 1997
ALCON PHARMS LTD
SOLA BARNES HIND
1%
1%
A089162 001
A084150 001
Jan 24, 1991
1% A084863 001
PENTOLAIR
PHARMAFAIR 0.5%
1%
A088643 001
A088150 001
Feb 09, 1987
Feb 25, 1983
CYCLOPHOSPHAMIDE
INJECTABLE;INJECTION
CYCLOPHOSPHAMIDE
BAXTER HLTHCARE
CYTOXAN
1GM/VIAL
100MG/VIAL
200MG/VIAL
500MG/VIAL
A088374 001
A088371 001
A088372 001
A088373 001
Sep 24, 1986
Jul 03, 1986
Jul 03, 1986
Jul 03, 1986
BAXTER HLTHCARE
CYTOXAN (LYOPHILIZED)
BAXTER HLTHCARE
LYOPHILIZED CYTOXAN
100MG/VIAL
200MG/VIAL
1GM/VIAL
2GM/VIAL
500MG/VIAL
N012142 001
N012142 002
N012142 010
N012142 009
N012142 008
Sep 24, 1985
Dec 10, 1985
Jan 04, 1984
BAXTER HLTHCARE
NEOSAR
100MG/VIAL
200MG/VIAL
N012142 006
N012142 007
Dec 05, 1985
Dec 10, 1985
TEVA PARENTERAL
TABLET;ORAL
CYTOXAN
1GM/VIAL
1GM/VIAL
2GM/VIAL
2GM/VIAL
100MG/VIAL
100MG/VIAL
200MG/VIAL
200MG/VIAL
500MG/VIAL
500MG/VIAL
A040015 004
A087442 004
A040015 005
A087442 005
A040015 001
A087442 001
A040015 002
A087442 002
A040015 003
A087442 003
Apr 29, 1993
Jul 08, 1983
Apr 29, 1993
Mar 30, 1989
Apr 29, 1993
Feb 16, 1982
Apr 29, 1993
Feb 16, 1982
Apr 29, 1993
Feb 16, 1982
BAXTER HLTHCARE 25MG N012141 002
50MG N012141 001
CYCLOSPORINE
CAPSULE;ORAL
NEORAL
NOVARTIS
SOLUTION;ORAL
CYCLOSPORINE
50MG N050715 003 Jul 14, 1995
APOTEX INC 100MG/ML A065167 001 Jan 05, 2005
CYCLOTHIAZIDE
TABLET;ORAL
ANHYDRON
LILLY 2MG N013157 002
FLUIDIL
PHARMACIA AND UPJOHN 2MG N018173 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-90( of 322)
CYCRIMINE HYDROCHLORIDE
TABLET;ORAL
PAGITANE
LILLY 1.25MG N008951 001
2.5MG N008951 002
CYPROHEPTADINE HYDROCHLORIDE
SYRUP;ORAL
CYPROHEPTADINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC
HALSEY
MORTON GROVE
NASKA
PERIACTIN
2MG/5ML
2MG/5ML
2MG/5ML
2MG/5ML
A086833 001
A089199 001
A087001 001
A089021 001
Jul 03, 1986
Nov 04, 1982
Dec 21, 1987
MERCK 2MG/5ML
TABLET;ORAL
CYPROHEPTADINE HYDROCHLORIDE
N013220 002
AM THERAP
ASCOT
DURAMED PHARMS BARR
HALSEY
KV PHARM
4MG
4MG
4MG
4MG
4MG
A088798 001
A087685 001
A088232 001
A089057 001
A086737 001
Feb 15, 1985
Oct 25, 1982
Oct 25, 1983
Jul 03, 1986
MD PHARM
MYLAN
4MG
4MG
A087566 001
A086678 001
Nov 10, 1982
PIONEER PHARMS
PLIVA
SANDOZ
4MG
4MG
4MG
A087839 001
A088205 001
A086808 001
Feb 08, 1984
Jul 26, 1983
SUPERPHARM 4MG A087405 001
TG UNITED LABS
VITARINE
4MG
4MG
A088212 001
A087284 001
May 26, 1983
WATSON LABS 4MG A085245 001
4MG A086165 001
4MG A086580 001
PERIACTIN
MERCK 4MG N012649 001
CYSTEINE HYDROCHLORIDE
INJECTABLE;INJECTION
CYSTEINE HYDROCHLORIDE
HOSPIRA 7.25% **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N019523 001 Oct 22, 1986
CYTARABINE
INJECTABLE;INJECTION
CYTARABINE
TEVA PARENTERAL 1GM/VIAL
2GM/VIAL
100MG/VIAL
500MG/VIAL
N016793 003
N016793 004
N016793 001
N016793 002
Dec 21, 1987
Dec 21, 1987
DACARBAZINE
INJECTABLE;INJECTION
DACARBAZINE
ABRAXIS PHARM 100MG/VIAL
200MG/VIAL
A070962 001
A070990 001
Aug 28, 1986
Aug 28, 1986
DALFOPRISTIN; QUINUPRISTIN
INJECTABLE;IV (INFUSION)
SYNERCID
KING PHARMS 420MG/VIAL;180MG/VIAL N050748 002 Aug 24, 2000
DALTEPARIN SODIUM
INJECTABLE;INJECTION
FRAGMIN
EISAI INC
INJECTABLE;SUBCUTANEOUS
FRAGMIN
7,500 IU/0.75ML N020287 008 Apr 04, 2002
EISAI INC 10,000IU/0.4ML (25,000IU/ML)
95,000IU/9.5ML (10,000IU/ML)
N020287 002
N020287 007
May 01, 2007
Apr 04, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
DANAPAROID SODIUM
INJECTABLE;INJECTION
ORGARAN
ORGANON USA INC 750 UNITS/0.6ML
DANAZOL
CAPSULE;ORAL
DANAZOL
AM THERAP 200MG
DANOCRINE
SANOFI AVENTIS US 50MG
100MG
200MG
DAPIPRAZOLE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
DAPIPRAZOLE HYDROCHLORIDE
FERA PHARMS 0.5%
DAPTOMYCIN
INJECTABLE;IV (INFUSION)
CUBICIN
CUBIST 250MG/VIAL
DARUNAVIR ETHANOLATE
TABLET;ORAL
PREZISTA
JANSSEN PRODS EQ 300MG BASE
EQ 400MG BASE
DAUNORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
CERUBIDINE
SANOFI AVENTIS US EQ 20MG BASE/VIAL
WYETH AYERST EQ 20MG BASE/VIAL
DAUNORUBICIN HYDROCHLORIDE
TEVA PARENTERAL EQ 20MG BASE/VIAL
EQ 50MG BASE/VIAL
DECAMETHONIUM BROMIDE
INJECTABLE;INJECTION
SYNCURINE
GLAXOSMITHKLINE 1MG/ML
DEMECARIUM BROMIDE
SOLUTION/DROPS;OPHTHALMIC
HUMORSOL
MERCK 0.125%
0.25%
DEMECLOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL
DECLOMYCIN
LEDERLE 150MG
SYRUP;ORAL
DECLOMYCIN
LEDERLE 75MG/5ML
TABLET;ORAL
DECLOMYCIN
COREPHARMA 75MG
150MG
300MG
DESERPIDINE
TABLET;ORAL
HARMONYL
ABBVIE 0.1MG
0.25MG
DESERPIDINE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
ORETICYL 25
ABBVIE 0.125MG;25MG
ORETICYL 50
ABBVIE 0.125MG;50MG
ORETICYL FORTE
ABBVIE 0.25MG;25MG
6-91( of 322)
N020430 001 Dec 24, 1996
A071569 001 Dec 30, 1987
N017557 003
N017557 004
N017557 002
N019849 001 Dec 31, 1990
N021572 001 Sep 12, 2003
N021976 001 Jun 23, 2006
N021976 003 Oct 21, 2008
A061876 001
N050484 001
A064212 001 Jun 23, 1998
A064212 002 May 03, 1999
N006931 002
N011860 002
N011860 001
N050262 001
N050257 001
N050261 001
N050261 002
N050261 003
N010796 001
N010796 002
N012148 001
N012148 003
N012148 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
DESERPIDINE; METHYCLOTHIAZIDE
TABLET;ORAL
ENDURONYL
ABBOTT 0.25MG;5MG
ENDURONYL FORTE
ABBOTT 0.5MG;5MG
METHYCLOTHIAZIDE AND DESERPIDINE
WATSON LABS
DESIPRAMINE HYDROCHLORIDE
CAPSULE;ORAL
PERTOFRANE
SANOFI AVENTIS US
TABLET;ORAL
DESIPRAMINE HYDROCHLORIDE
BARR LABS INC
PLIVA
USL PHARMA
DESLANOSIDE
INJECTABLE;INJECTION
CEDILANID-D
NOVARTIS
DESMOPRESSIN ACETATE
INJECTABLE;INJECTION
DDAVP
SANOFI AVENTIS US
DESMOPRESSIN ACETATE
BEDFORD
DESMOPRESSIN ACETATE PRESERVATIVE FREE
0.25MG;5MG
0.5MG;5MG
25MG
50MG
150MG
25MG
50MG
75MG
100MG
25MG
50MG
75MG
100MG
0.2MG/ML
0.015MG/ML
0.004MG/ML
BEDFORD
SOLUTION;NASAL
CONCENTRAID
FERRING
SPRAY, METERED;NASAL
DDAVP
SANOFI AVENTIS US
STIMATE
CSL BEHRING
DESOGESTREL; ETHINYL ESTRADIOL
TABLET;ORAL-21
DESOGEN
ORGANON USA INC
0.004MG/ML
0.01%
0.01MG/SPRAY
0.15MG/SPRAY
0.15MG;0.03MG
DESOGESTREL AND ETHINYL ESTRADIOL
DURAMED PHARMS BARR 0.15MG;0.03MG
ORTHO-CEPT
JANSSEN PHARMS
DESONIDE
CREAM;TOPICAL
DESONIDE
TEVA PHARMS
DESOXIMETASONE
CREAM;TOPICAL
TOPICORT
TARO PHARMS NORTH
TOPICORT LP
TARO PHARMS NORTH
GEL;TOPICAL
TOPICORT
TARO PHARMS NORTH
OINTMENT;TOPICAL
DESOXIMETASONE
ALTANA
0.15MG;0.03MG
0.05%
0.25%
0.05%
0.05%
0.25%
6-92( of 322)
N012775 001
N012775 002
A088486 001 Aug 10, 1984
A088452 001 Aug 10, 1984
N013621 001
N013621 002
A071804 001 May 29, 1997
A071800 001 Dec 08, 1987
A071801 001 Dec 08, 1987
A071802 001 Dec 08, 1987
A071803 001 May 29, 1997
A071864 001 Sep 09, 1987
A071865 001 Sep 09, 1987
A071866 001 Sep 09, 1987
A071867 001 Sep 09, 1987
N009282 002
N018938 002 Apr 25, 1995
A074575 001 Feb 18, 2000
A074574 001 Feb 18, 2000
N019776 001 Dec 26, 1990
N017922 002 Feb 06, 1989
N020355 001 Mar 07, 1994
N020071 001 Dec 10, 1992
A075256 001 Aug 12, 1999
N020301 001 Dec 14, 1992
A074027 001 Sep 28, 1992
N017856 001
N018309 001
N018586 001 Mar 29, 1982
A073440 001 Apr 01, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-93( of 322)
DESOXIMETASONE
OINTMENT;TOPICAL
TOPICORT
TARO PHARMS NORTH 0.25% N018763 001 Sep 30, 1983
DESOXYCORTICOSTERONE ACETATE
INJECTABLE;INJECTION
DOCA
ORGANON USA INC
PELLET;IMPLANTATION
PERCORTEN
5MG/ML N001104 001
NOVARTIS 125MG N005151 001
DESOXYCORTICOSTERONE PIVALATE
INJECTABLE;INJECTION
PERCORTEN
NOVARTIS 25MG/ML N008822 001
DEXAMETHASONE
AEROSOL;TOPICAL
AEROSEB-DEX
ALLERGAN HERBERT 0.01% **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
A083296 002
DECASPRAY
MERCK 0.04% **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N012731 002
ELIXIR;ORAL
DECADRON
MERCK
DEXAMETHASONE
0.5MG/5ML N012376 002
ALPHARMA US PHARMS
HEXADROL
0.5MG/5ML A088997 001 Oct 10, 1986
ORGANON USA INC
GEL;TOPICAL
DECADERM
0.5MG/5ML N012674 001
MERCK 0.1% N013538 001
SUSPENSION/DROPS;OPHTHALMIC
DEXAMETHASONE
WATSON LABS
TABLET;ORAL
DECADRON
0.1% A089170 001 May 09, 1989
MERCK 0.25MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N011664 004
0.5MG N011664 001
0.75MG N011664 002
1.5MG N011664 003
4MG N011664 005
DEXAMETHASONE
6MG N011664 006 Jul 30, 1982
IMPAX LABS 0.75MG A085376 001
MUTUAL PHARM 0.25MG A084013 001
0.25MG A084764 001
0.5MG A084084 001
0.5MG A084766 001
0.75MG A084081 001
0.75MG A084765 001
1.5MG A084086 001
1.5MG A084763 001
PAR PHARM
PHOENIX LABS NY
0.25MG
0.75MG
A088149 001
A083806 001
Apr 28, 1983
PVT FORM 0.75MG A083420 001
ROXANE 0.25MG A084614 001
SANDOZ 0.75MG A080399 001
UPSHER SMITH 0.75MG A087534 001
1.5MG A087533 001
WATSON LABS 0.25MG A085455 001
0.5MG A085458 001
0.75MG A080968 001
0.75MG A084457 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
A085818 001
A085456 001
A085840 001
A084327 001
A084991 001
A084993 001
A084990 001
A084992 001
N012675 004
N012675 007
N012675 009
N012675 010
N016675 001
A084315 001
A087711 001
N014242 001
N013413 001
N011983 002
N012071 002
N012071 004
A084342 001
A088448 001
A088469 001
A084493 001
A084752 001
A083161 001
A084282 001
A088522 001
A087065 001
A081125 001
A081126 001
A083702 001
A084355 001
A089169 001
A087668 001
A085606 001
A085641 001
N014694 002
N014694 003
N014694 004
6-94( of 322)
May 24, 1982
Jan 25, 1984
Jan 25, 1984
Feb 17, 1984
Aug 31, 1990
Aug 31, 1990
Apr 09, 1986
Jul 01, 1982
DEXAMETHASONE
TABLET;ORAL
DEXAMETHASONE
WHITEWORTH TOWN PLSN
DEXONE 0.5
SOLVAY
DEXONE 0.75
SOLVAY
DEXONE 1.5
SOLVAY
DEXONE 4
SOLVAY
HEXADROL
ORGANON USA INC
DEXAMETHASONE ACETATE
INJECTABLE;INJECTION
DECADRON-LA
MERCK
DEXAMETHASONE ACETATE
WATSON LABS
DEXAMETHASONE SODIUM PHOSPHATE
AEROSOL;NASAL
DEXACORT
UCB INC
AEROSOL, METERED;INHALATION
DEXACORT
UCB INC
CREAM;TOPICAL
DECADRON
MERCK
INJECTABLE;INJECTION
DECADRON
MERCK
DEXACEN-4
CENT PHARMS
DEXAMETHASONE
ABRAXIS PHARM
FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE
0.75MG
1.5MG
1.5MG
0.75MG
0.5MG
0.75MG
1.5MG
4MG
0.5MG
0.75MG
1.5MG
4MG
EQ 8MG BASE/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 8MG BASE/ML
EQ 16MG BASE/ML
EQ 0.1MG PHOSPHATE/INH
EQ 0.1MG PHOSPHATE/INH
EQ 0.1% PHOSPHATE
EQ 4MG PHOSPHATE/ML
EQ 24MG PHOSPHATE/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 10MG PHOSPHATE/ML
AKORN
BEL MAR
DELL LABS
HIKMA MAPLE
INTL MEDICATION
LYPHOMED
TEVA PARENTERAL
WATSON LABS
WYETH AYERST
HEXADROL
ORGANON USA INC
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 20MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 10MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 10MG PHOSPHATE/ML
EQ 24MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 10MG PHOSPHATE/ML
EQ 20MG PHOSPHATE/ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
DEXAMETHASONE SODIUM PHOSPHATE
OINTMENT;OPHTHALMIC
DECADRON
MERCK EQ 0.05% PHOSPHATE
DEXAIR
PHARMAFAIR EQ 0.05% PHOSPHATE
MAXIDEX
ALCON EQ 0.05% PHOSPHATE
SOLUTION/DROPS;OPHTHALMIC
DEXAIR
PHARMAFAIR EQ 0.1% PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE
SOLA BARNES HIND EQ 0.1% PHOSPHATE
EQ 0.1% PHOSPHATE
SOLUTION/DROPS;OPHTHALMIC, OTIC
DECADRON
MERCK EQ 0.1% PHOSPHATE
SOLUTION/DROPS;OTIC
DEXAMETHASONE SODIUM PHOSPHATE
AKORN EQ 0.1% PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
DECADRON W/ XYLOCAINE
MERCK EQ 4MG PHOSPHATE/ML;10MG/ML
DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
OINTMENT;OPHTHALMIC
NEODECADRON
MERCK EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM
SOLUTION/DROPS;OPHTHALMIC
NEODECADRON
MERCK EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE
BAUSCH AND LOMB EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE
ALCON PHARMS LTD EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
PHARMAFAIR EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
DEXACIDIN
NOVARTIS
DEXASPORIN
PHARMAFAIR
SUSPENSION/DROPS;OPHTHALMIC
DEXACIDIN
NOVARTIS
DEXASPORIN
PHARMAFAIR
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
ALCON PHARMS LTD 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
DEXBROMPHENIRAMINE MALEATE
SYRUP;ORAL
DISOMER
SCHERING 2MG/5ML
TABLET;ORAL
DISOMER
SCHERING 2MG
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET;ORAL
DISOPHROL
SCHERING 2MG;60MG
TABLET, EXTENDED RELEASE;ORAL
BROMPHERIL
COPLEY PHARM
DISOBROM
SANDOZ
RESPORAL
PIONEER PHARMS
6MG;120MG
6MG;120MG
6MG;120MG
0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
6-95( of 322)
N011977 001
A088071 001 Dec 28, 1982
A083342 001
A088433 001 Dec 15, 1983
A084170 001
A084173 001
N011984 001
A084855 001
N013334 002
N050324 001
N050322 001
A064055 001 Oct 30, 1995
A062714 001 Jul 21, 1986
A062539 001 Jan 10, 1985
A062566 001 Feb 22, 1985
A062411 001 May 16, 1983
A062544 001 Oct 29, 1984
A062428 001 May 18, 1983
A062721 001 Nov 17, 1986
N011814 002
N011814 001
N012394 002
A089116 001 Jan 22, 1987
A070770 001 Sep 30, 1991
A089139 001 Jun 16, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-96( of 322)
DEXCHLORPHENIRAMINE MALEATE
SYRUP;ORAL
POLARAMINE
SCHERING 2MG/5ML
TABLET;ORAL
DEXCHLORPHENIRAMINE MALEATE
A086837 001 Jul 19, 1982
PLIVA
POLARAMINE
2MG A088682 001 Jan 17, 1986
SCHERING 2MG A086835 001
DEXTROAMPHETAMINE SULFATE
CAPSULE;ORAL
DEXAMPEX
TEVA 15MG A085355 001
CAPSULE, EXTENDED RELEASE;ORAL
DEXTROAMPHETAMINE SULFATE
ABLE
ELIXIR;ORAL
DEXEDRINE
5MG
10MG
15MG
A076814 001
A076814 002
A076814 003
Aug 25, 2004
Aug 25, 2004
Aug 25, 2004
GLAXOSMITHKLINE
TABLET;ORAL
DEXAMPEX
5MG/5ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
A083902 001
TEVA 5MG A083735 001
10MG A083735 002
DEXEDRINE
GLAXOSMITHKLINE 5MG A084935 001
DEXTROAMPHETAMINE SULFATE
HALSEY 10MG A083930 001
LANNETT 5MG A083903 001
10MG A083903 003
15MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
A085652 001
MAST MM 5MG A086521 001
NESHER PHARMS
PUREPAC PHARM
5MG
10MG
5MG
A040365 001
A040367 001
A084125 001
Oct 31, 2002
Oct 31, 2002
SANDOZ 5MG A085370 001
10MG A085371 001
VINTAGE PHARMS LLC
VITARINE
5MG
5MG
A040299 001
A084986 001
May 13, 1999
10MG A085892 001
DEXTROSTAT
SHIRE 5MG A084051 001
10MG A084051 002
FERNDEX
FERNDALE LABS 5MG A084001 001
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PHERAZINE DM
HALSEY 15MG/5ML;6.25MG/5ML
PROMETHAZINE HYDROCHLORIDE AND DESTROMETHORPHAN HYDROBROMIDE
A088913 001 Mar 02, 1987
ANI PHARMS 15MG/5ML;6.25MG/5ML N011265 002 Apr 02, 1984
DEXTROSE
INJECTABLE;INJECTION
DEXTROSE 10% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML
MILES 10GM/100ML
DEXTROSE 2.5% IN PLASTIC CONTAINER
N018046 001
N018504 001
B BRAUN 2.5GM/100ML
2.5GM/100ML
DEXTROSE 38.5% IN PLASTIC CONTAINER
N018358 001
N019626 001 Feb 02, 1988
ABBOTT 38.5GM/100ML
DEXTROSE 5% IN PLASTIC CONTAINER
N018923 001 Sep 19, 1984
DHL 5GM/100ML N019971 001 Sep 28, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-97( of 322)
DEXTROSE
INJECTABLE;INJECTION
DEXTROSE 60%
B BRAUN 60GM/100ML
DEXTROSE 60% IN PLASTIC CONTAINER
N017995 002 Sep 22, 1982
B BRAUN 60GM/100ML
BAXTER HLTHCARE 60GM/100ML
HOSPIRA 60GM/100ML
DEXTROSE 7.7% IN PLASTIC CONTAINER
N017995 001
N020047 002
N019346 001
Jul 02, 1991
Jan 25, 1985
B BRAUN 7.7GM/100ML N019626 003 Feb 02, 1988
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
INJECTABLE;INJECTION
ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;31MG/100ML;130MG/100ML;26MG/1 N019025 001 Dec 27, 1984
00ML;320MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
ISOLYTE H W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;30MG/100ML;97MG/100ML;220MG/1 N018273 001
00ML;140MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
GLUCONATE
INJECTABLE;INJECTION
ISOLYTE S W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;30MG/100ML;37MG/100ML;370MG/1
00ML;530MG/100ML;500MG/100ML
DEXTROSE; POTASSIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;37MG/100ML
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;75MG/100ML
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML
5GM/100ML;220MG/100ML
N018274 001
N019699 001 Sep 29, 1989
N019699 002 Sep 29, 1989
N019699 003 Sep 29, 1989
N018744 003 Nov 09, 1982
N019699 005 Sep 29, 1989
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM LACTATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC
ANHYDROUS
INJECTABLE;INJECTION
IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;111MG/100ML;256MG/100ML;146MG N019514 001 May 08, 1986
/100ML;207MG/100ML
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;130MG/100ML;280MG N018270 001
/100ML;91MG/100ML
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%
B BRAUN 5GM/100ML;75MG/100ML;200MG/100ML N018268 009
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;200MG/100ML N018268 004
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;200MG/100ML N018268 005
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;300MG/100ML;200MG/100ML N018268 006
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;75MG/100ML;330MG/100ML N018268 011 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;330MG/100ML N018268 012 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;330MG/100ML N018268 013 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;300MG/100ML;330MG/100ML N018268 014 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%
B BRAUN 5GM/100ML;75MG/100ML;450MG/100ML N018268 010
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;450MG/100ML N018268 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-98( of 322)
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;450MG/100ML N018268 002
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;300MG/100ML;450MG/100ML N018268 003
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;224MG/100ML;450MG/100ML N018008 003
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 001
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;75MG/100ML;450MG/100ML
DEXTROSE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;200MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;450MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;900MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;450MG/100ML
HOSPIRA 2.5GM/100ML;450MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;900MG/100ML
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
ABBOTT 3.3GM/100ML;300MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;200MG/100ML
MILES 5GM/100ML;200MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;225MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;300MG/100ML
MILES 5GM/100ML;300MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;330MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;450MG/100ML
B BRAUN 5GM/100ML;450MG/100ML
MILES 5GM/100ML;450MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABBOTT
B BRAUN
MILES
DEXTROTHYROXINE SODIUM
TABLET;ORAL
CHOLOXIN
ABBVIE
DEZOCINE
INJECTABLE;INJECTION
DALGAN
ASTRAZENECA
DIATRIZOATE MEGLUMINE
INJECTABLE;INJECTION
ANGIOVIST 282
BAYER HLTHCARE
CARDIOGRAFIN
BRACCO
DIATRIZOATE MEGLUMINE
BRACCO
HYPAQUE
GE HEALTHCARE
5GM/100ML;900MG/100ML
5GM/100ML;900MG/100ML
5GM/100ML;900MG/100ML
1MG
2MG
4MG
6MG
5MG/ML
10MG/ML
15MG/ML
60%
85%
76%
30%
N018008 002
N018386 001
N018229 001
N018047 001
N018030 001
N018096 001
N018376 001
N018055 001
N018030 005
N018030 004
N018399 001
N019482 001 Oct 04, 1985
N019486 001 Oct 04, 1985
N018501 001
N018030 003
N019484 001 Oct 04, 1985
N018030 002
N018400 001
N019483 001 Oct 04, 1985
N018026 001
N018500 001
N012302 005
N012302 002
N012302 004
N012302 006
N019082 001 Dec 29, 1989
N019082 002 Dec 29, 1989
N019082 003 Dec 29, 1989
A087726 001 Sep 23, 1982
N011620 002
N010040 017
N016403 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
DIATRIZOATE MEGLUMINE
INJECTABLE;INJECTION
HYPAQUE
60%
RENO-60
BRACCO 60%
RENO-DIP
BRACCO 30%
UROVIST MEGLUMINE DIU/CT
BAYER HLTHCARE 30%
SOLUTION;URETERAL
RENO-30
BRACCO 30%
UROVIST CYSTO
BAYER HLTHCARE 30%
UROVIST CYSTO PEDIATRIC
BAYER HLTHCARE 30%
SOLUTION;URETHRAL
HYPAQUE-CYSTO
GE HEALTHCARE 30%
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
INJECTABLE;INJECTION
ANGIOVIST 292
BAYER HLTHCARE 52%;8%
ANGIOVIST 370
BAYER HLTHCARE 66%;10%
DIATRIZOATE-60
INTL MEDICATION 52%;8%
HYPAQUE-76
GE HEALTHCARE 66%;10%
HYPAQUE-M,75%
GE HEALTHCARE 50%;25%
HYPAQUE-M,90%
GE HEALTHCARE 60%;30%
MD-60
MALLINCKRODT 52%;8%
MD-76
MALLINCKRODT 66%;10%
RENOCAL-76
BRACCO 66%;10%
RENOGRAFIN-60
BRACCO 52%;8%
RENOVIST
BRACCO 34.3%;35%
RENOVIST II
BRACCO 28.5%;29.1%
SOLUTION;ORAL, RECTAL
GASTROVIST
BAYER HLTHCARE 66%;10%
DIATRIZOATE SODIUM
FOR SOLUTION;ORAL, RECTAL
HYPAQUE
GE HEALTHCARE 100%
INJECTABLE;INJECTION
HYPAQUE
GE HEALTHCARE 25%
50%
MD-50
MALLINCKRODT 50%
UROVIST SODIUM 300
BAYER HLTHCARE 50%
SOLUTION;ORAL, RECTAL
HYPAQUE
GE HEALTHCARE 40%
SOLUTION;URETERAL
HYPAQUE SODIUM 20%
GE HEALTHCARE 20%
6-99( of 322)
N016403 001
N010040 016
N010040 012
A087739 001 Sep 23, 1982
N010040 021
A087729 001 Sep 23, 1982
A087731 001 Sep 23, 1982
N016403 003
A087724 001 Sep 23, 1982
A087723 001 Sep 23, 1982
A088166 001 Jun 17, 1983
A086505 001
N010220 003
N010220 002
A087074 001
A087073 001
A089347 001 Jun 01, 1988
N010040 006
N010040 020
N010040 019
A087728 001 Sep 23, 1982
N011386 001
N009561 003
N009561 001
A087075 001
A087725 001 Sep 23, 1982
N011386 003
N009561 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-100( of 322)
DIAZEPAM
CAPSULE, EXTENDED RELEASE;ORAL
VALRELEASE
ROCHE 15MG N018179 001
GEL;RECTAL
DIASTAT
VALEANT 5MG/ML (5MG/ML) **Federal Register N020648 002 Jul 29, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
10MG/2ML (5MG/ML) N020648 003 Jul 29, 1997
15MG/3ML (5MG/ML) N020648 004 Jul 29, 1997
20MG/4ML (5MG/ML) N020648 005 Jul 29, 1997
INJECTABLE;INJECTION
DIAZEPAM
ABRAXIS PHARM 5MG/ML A070662 001 Jun 25, 1986
HIKMA MAPLE 5MG/ML A070311 001 Dec 16, 1985
5MG/ML A070312 001 Dec 16, 1985
5MG/ML A070313 001 Dec 16, 1985
5MG/ML A071308 001 Jul 17, 1987
5MG/ML A071309 001 Jul 17, 1987
5MG/ML A071310 001 Jul 17, 1987
HOSPIRA 5MG/ML A071584 001 Oct 13, 1987
MARSAM PHARMS LLC 5MG/ML A072370 001 Jan 29, 1993
5MG/ML A072371 001 Jan 29, 1993
5MG/ML A072397 001 Jan 29, 1993
PARENTA PHARMS 5MG/ML A076815 001 Apr 15, 2004
US ARMY 5MG/ML N020124 001 Dec 05, 1990
WARNER CHILCOTT 5MG/ML A071613 001 Oct 22, 1987
5MG/ML A071614 001 Oct 22, 1987
WATSON LABS 5MG/ML A070296 001 Feb 12, 1986
5MG/ML A070911 001 Aug 28, 1986
5MG/ML A070912 001 Aug 28, 1986
5MG/ML A070930 001 Dec 01, 1986
DIZAC
PHARMACIA AND UPJOHN 5MG/ML N019287 001 Jun 18, 1993
VALIUM
ROCHE 5MG/ML N016087 001
TABLET;ORAL
DIAZEPAM
ACTAVIS ELIZABETH 2MG A070781 001 Mar 19, 1986
5MG A070706 001 Mar 19, 1986
10MG A070707 001 Mar 19, 1986
DAVA PHARMS INC 5MG A070227 001 Sep 26, 1985
10MG A070228 001 Sep 26, 1985
DURAMED PHARMS BARR 2MG A070894 001 Aug 27, 1986
5MG A070895 001 Aug 27, 1986
10MG A070896 001 Aug 27, 1986
FERNDALE LABS 2MG A070903 001 Apr 01, 1987
5MG A070904 001 Apr 01, 1987
10MG A070905 001 Apr 01, 1987
HALSEY 2MG A070987 001 Aug 15, 1986
5MG A070996 001 Aug 15, 1986
10MG A070956 001 Aug 15, 1986
IVAX SUB TEVA PHARMS 2MG A070360 001 Sep 04, 1985
5MG A070361 001 Sep 04, 1985
10MG A070362 001 Sep 04, 1985
MARTEC USA LLC 10MG A072402 001 Apr 25, 1989
PAR PHARM 2MG A070462 001 Feb 25, 1986
5MG A070463 001 Feb 25, 1986
10MG A070464 001 Feb 25, 1986
PIONEER PHARMS 2MG A070787 001 Aug 02, 1988
5MG A070788 001 Aug 02, 1988
10MG A070776 001 Aug 02, 1988
ROXANE 2MG A070356 001 Jun 17, 1986
5MG A070357 001 Jun 17, 1986
10MG A070358 001 Jun 17, 1986
SANDOZ 2MG A070302 001 Dec 20, 1985
5MG A070303 001 Dec 20, 1985
10MG A070304 001 Dec 20, 1985
TEVA PHARMS 5MG A070153 001 Nov 01, 1985
WARNER CHILCOTT 2MG A070209 001 Sep 04, 1985
5MG A070210 001 Sep 04, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-101( of 322)
DIAZEPAM
TABLET;ORAL
DIAZEPAM
10MG A070222 001 Sep 04, 1985
WATSON LABS 2MG A070456 001 Nov 01, 1985
5MG A070457 001 Nov 01, 1985
10MG A070458 001 Nov 01, 1985
Q-PAM
QUANTUM PHARMICS 2MG A070423 001 Dec 12, 1985
2MG A072431 001 Apr 29, 1988
5MG A070424 001 Dec 12, 1985
5MG A072432 001 Apr 29, 1988
10MG A070425 001 Dec 12, 1985
10MG A072433 001 Apr 29, 1988
DIAZOXIDE
CAPSULE;ORAL
PROGLYCEM
TEVA BRANDED PHARM 50MG N017425 001
100MG N017425 002
INJECTABLE;INJECTION
DIAZOXIDE
ABRAXIS PHARM 15MG/ML A071519 001 Aug 26, 1987
HYPERSTAT
SCHERING 15MG/ML N016996 001
DIBUCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
HEAVY SOLUTION NUPERCAINE
NOVARTIS 2.5MG/ML N006203 001
DICHLORPHENAMIDE
TABLET;ORAL
DARANIDE
TARO 50MG **Federal Register determination N011366 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
DICLOFENAC POTASSIUM
TABLET;ORAL
CATAFLAM
NOVARTIS 25MG **Federal Register determination N020142 001 Nov 24, 1993
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
DICLOFENAC POTASSIUM
MUTUAL PHARM 50MG A075470 001 Feb 21, 2002
SANDOZ 50MG A075582 001 Feb 23, 2001
WATSON LABS 50MG A075152 001 Nov 27, 1998
DICLOFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC
DICLOFENAC SODIUM
APOTEX INC 0.1% A077600 001 Nov 13, 2008
FALCON PHARMS 0.1% N020809 001 May 04, 1998
TABLET, DELAYED RELEASE;ORAL
DICLOFENAC SODIUM
NOSTRUM LABS 50MG A074986 001 Feb 26, 1999
75MG A074986 002 Feb 26, 1999
PLIVA 50MG A074432 002 Jul 29, 1999
75MG A074432 003 Jul 29, 1999
ROXANE 25MG A074391 001 Jun 29, 1995
50MG A074391 002 Jun 29, 1995
75MG A074391 003 Jun 29, 1995
TEVA 50MG A074723 001 Mar 30, 1999
75MG A074390 001 Aug 15, 1996
TEVA PHARMS 25MG A074459 001 Jun 25, 1997
50MG A074459 002 Jun 25, 1997
75MG A074459 003 Jun 25, 1997
VOLTAREN
NOVARTIS 25MG N019201 001 Jul 28, 1988
50MG N019201 002 Jul 28, 1988
75MG N019201 003 Jul 28, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
DICLOXACILLIN SODIUM
CAPSULE;ORAL
DYCILL
GLAXOSMITHKLINE
PATHOCIL
WYETH AYERST
FOR SUSPENSION;ORAL
DICLOXACILLIN SODIUM
APOTHECON
DYNAPEN
APOTHECON
PATHOCIL
WYETH AYERST
DICUMAROL
CAPSULE;ORAL
DICUMAROL
LILLY
TABLET;ORAL
DICUMAROL
ABBVIE
DICYCLOMINE HYDROCHLORIDE
CAPSULE;ORAL
DICYCLOMINE HYDROCHLORIDE
MUTUAL PHARM
PIONEER PHARMS
WATSON LABS
WEST WARD
INJECTABLE;INJECTION
DICYCLOMINE HYDROCHLORIDE
WATSON LABS
SYRUP;ORAL
DICYCLOMINE HYDROCHLORIDE
ALPHARMA US PHARMS
TABLET;ORAL
DICYCLOMINE HYDROCHLORIDE
MUTUAL PHARM
PIONEER PHARMS
WATSON LABS
WEST WARD
DIDANOSINE
FOR SOLUTION;ORAL
VIDEX
BRISTOL MYERS SQUIBB
TABLET, CHEWABLE;ORAL
VIDEX
BRISTOL MYERS SQUIBB
DIENESTROL
CREAM;VAGINAL
DIENESTROL
ORTHO MCNEIL PHARM
DV
SANOFI AVENTIS US
ESTRAGUARD
SOLVAY
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 62.5MG BASE/5ML
EQ 62.5MG BASE/5ML
EQ 62.5MG BASE/5ML
25MG
50MG
25MG
50MG
100MG
10MG
10MG
10MG
10MG
10MG/ML
10MG/5ML
20MG
20MG
20MG
20MG
100MG/PACKET
167MG/PACKET
250MG/PACKET
375MG/PACKET
25MG
50MG
100MG
150MG
200MG
0.01%
0.01%
0.01%
6-102( of 322)
A060254 002
A062238 001
A060254 003
A062238 002
N050011 002
N050011 003 Mar 28, 1983
A061455 001
N050337 002
N050092 001
N005509 003
N005509 001
N005545 003
N005545 004
N005545 005
A084505 001 Oct 21, 1986
A089361 001 Jan 10, 1989
A083179 001 Feb 12, 1986
A040204 001 Feb 28, 1997
A080614 001 Feb 11, 1986
A084479 001
A084600 001 Jul 29, 1985
A088585 001 Aug 20, 1986
A084361 001 Feb 06, 1986
A040161 001 Oct 01, 1996
N020155 003 Oct 09, 1991
N020155 004 Oct 09, 1991
N020155 005 Oct 09, 1991
N020155 006 Oct 09, 1991
N020154 002 Oct 09, 1991
N020154 003 Oct 09, 1991
N020154 004 Oct 09, 1991
N020154 005 Oct 09, 1991
N020154 006 Oct 28, 1999
N006110 005
A083518 001
A084436 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
DIENESTROL
SUPPOSITORY;VAGINAL
DV
SANOFI AVENTIS US 0.7MG
DIETHYLCARBAMAZINE CITRATE
TABLET;ORAL
HETRAZAN
LEDERLE 50MG
DIETHYLPROPION HYDROCHLORIDE
TABLET;ORAL
DIETHYLPROPION HYDROCHLORIDE
SANDOZ 25MG
TEVA 25MG
TG UNITED LABS 25MG
25MG
UCB INC 25MG
WATSON LABS 25MG
TENUATE
SANOFI AVENTIS US 25MG
TEPANIL
3M 25MG
TABLET, EXTENDED RELEASE;ORAL
TENUATE
SANOFI AVENTIS US 75MG
TEPANIL TEN-TAB
3M 75MG
DIETHYLSTILBESTROL
INJECTABLE;INJECTION
STILBESTROL
BRISTOL MYERS SQUIBB 0.2MG/ML
0.5MG/ML
1MG/ML
5MG/ML
SUPPOSITORY;VAGINAL
DIETHYLSTILBESTROL
LILLY 0.1MG
0.5MG
STILBESTROL
BRISTOL MYERS SQUIBB 0.1MG
0.5MG
TABLET;ORAL
DIETHYLSTILBESTROL
LILLY 0.1MG
0.5MG
1MG
5MG
STILBESTROL
TABLICAPS 0.5MG
1MG
5MG
STILBETIN
BRISTOL MYERS SQUIBB 0.1MG
0.25MG
0.5MG
1MG
5MG
TABLET, DELAYED RELEASE;ORAL
DIETHYLSTILBESTROL
LILLY 0.1MG
0.25MG
0.5MG
1MG
5MG
STILBESTROL
TABLICAPS 0.5MG
1MG
5MG
STILBETIN
BRISTOL MYERS SQUIBB 0.1MG
0.5MG
1MG
6-103( of 322)
A083517 001
N006459 001
A085916 001
A088642 001 Sep 20, 1984
A088267 001 Aug 25, 1983
A088268 001 Aug 25, 1983
A085544 001
A085741 001
N017668 001
N011673 001
N017669 001
N017956 001
N004056 003
N004056 004
N004056 005
N004056 006
N004040 001
N004040 002
N004056 001
N004056 002
N004041 002
N004041 003
N004041 004
N004041 005
A083004 001
A083002 001
A083006 001
N004056 007
N004056 017
N004056 008
N004056 009
N004056 010
N004039 002
N004039 005
N004039 003
N004039 004
N004039 006
A083003 001
A083005 001
A083007 001
N004056 011
N004056 012
N004056 013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
DIETHYLSTILBESTROL
TABLET, DELAYED RELEASE;ORAL
STILBETIN
DIETHYLSTILBESTROL DIPHOSPHATE
INJECTABLE;INJECTION
STILPHOSTROL
BAYER PHARMS
TABLET;ORAL
STILPHOSTROL
BAYER PHARMS
DIFLORASONE DIACETATE
CREAM;TOPICAL
DIFLORASONE DIACETATE
FOUGERA PHARMS
FLORONE
PHARMACIA AND UPJOHN
FLORONE E
PHARMACIA AND UPJOHN
PSORCON
TARO PHARMS NORTH
OINTMENT;TOPICAL
PSORCON
PHARMACIA AND UPJOHN
PSORCON E
PHARMACIA AND UPJOHN
DIFLUNISAL
TABLET;ORAL
DIFLUNISAL
PUREPAC PHARM
ROXANE
SANDOZ
TEVA
WATSON LABS
DOLOBID
MERCK
DIGITOXIN
INJECTABLE;INJECTION
CRYSTODIGIN
LILLY
DIGOXIN
CAPSULE;ORAL
LANOXICAPS
GLAXOSMITHKLINE LLC
INJECTABLE;INJECTION
DIGOXIN
ABRAXIS PHARM
HOSPIRA
WYETH AYERST
DIGOXIN PEDIATRIC
HOSPIRA
TABLET;ORAL
DIGOXIN
CARACO
MYLAN PHARMS INC
LANOXIN
COVIS PHARMA
5MG
250MG/5ML
50MG
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
250MG
500MG
250MG
500MG
500MG
250MG
250MG
500MG
250MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
500MG
0.2MG/ML
0.05MG
0.1MG
0.15MG
0.2MG
0.25MG/ML
0.25MG/ML
0.25MG/ML
0.25MG/ML
0.1MG/ML
0.125MG
0.25MG
0.125MG
0.25MG
0.0625MG
N004056 014
N010010 001
N010010 002
A075187 001
N017741 001
N019259 001
N020205 001
N019260 001
N017994 001
A074285 001
A074285 002
A073562 001
A073563 001
A074604 001
A073679 001
A074400 001
A074400 002
N018445 001
N018445 002
A084100 005
N018118 002
N018118 003
N018118 004
N018118 001
A083217 001
A040093 001
A040206 001
A084386 001
A040092 001
A076363 001
A076363 002
A040282 001
A040282 002
N020405 001
6-104( of 322)
Mar 30, 1998
Aug 28, 1985
Nov 20, 1992
Aug 28, 1985
May 07, 1996
May 07, 1996
Nov 27, 1992
Nov 27, 1992
Jun 10, 1996
Jul 31, 1992
Jul 17, 1997
Jul 17, 1997
Apr 19, 1982
Apr 19, 1982
Jul 26, 1982
Jul 26, 1982
Sep 24, 1984
Jul 26, 1982
May 16, 1996
Aug 28, 1998
Apr 25, 1996
Jan 31, 2003
Jan 31, 2003
Dec 23, 1999
Dec 23, 1999
Sep 30, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-105( of 322)
DIGOXIN
TABLET;ORAL
LANOXIN
0.1875MG N020405 003 Sep 30, 1997
0.375MG N020405 005 Sep 30, 1997
0.5MG N020405 006 Sep 30, 1997
DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
EMBOLEX
NOVARTIS 0.5MG/0.5ML;2,500
UNITS/0.5ML;5.33MG/0.5ML
0.5MG/0.7ML;5,000
UNITS/0.7ML;7.46MG/0.7ML
N018885 001
N018885 002
Nov 30, 1984
Nov 30, 1984
DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
CARDIZEM SR
BIOVAIL
DILTIAZEM HYDROCHLORIDE
60MG
90MG
120MG
180MG
N019471 001
N019471 002
N019471 003
N019471 004
Jan 23, 1989
Jan 23, 1989
Jan 23, 1989
Jan 23, 1989
BIOVAIL
TEVA
INJECTABLE;INJECTION
CARDIZEM
60MG
90MG
120MG
120MG
180MG
240MG
300MG
360MG
420MG
60MG
90MG
120MG
A074845 001
A074845 002
A074845 003
N020939 001
N020939 002
N020939 003
N020939 004
N020939 005
N020939 006
A074079 001
A074079 002
A074079 003
Sep 15, 1999
Sep 15, 1999
Sep 15, 1999
Jan 28, 2000
Jan 28, 2000
Jan 28, 2000
Jan 28, 2000
Sep 14, 2001
Sep 14, 2001
Nov 30, 1993
Nov 30, 1993
Nov 30, 1993
BIOVAIL
BIOVAIL LABS INTL
DILTIAZEM HYDROCHLORIDE
100MG/VIAL
5MG/ML
25MG/VIAL **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
N020792 001
N020027 001
N020027 003
Sep 05, 1997
Oct 24, 1991
Aug 18, 1995
APOTEX INC
HOSPIRA
TEVA PHARMS USA
TABLET;ORAL
DILTIAZEM HYDROCHLORIDE
5MG/ML
5MG/ML
5MG/ML
5MG/ML
A075375 001
A075004 001
A075106 001
A074894 001
Sep 30, 1999
Feb 16, 2000
Apr 29, 1999
Aug 26, 1997
APOTHECON
DAVA PHARMS INC
IVAX SUB TEVA PHARMS
TEVA
TEVA PHARMS
30MG
60MG
90MG
120MG
30MG
60MG
90MG
120MG
30MG
60MG
90MG
120MG
30MG
60MG
30MG
60MG
90MG
120MG
A074051 001
A074051 002
A074051 003
A074051 004
A074093 001
A074093 002
A074093 003
A074093 004
A074168 001
A074168 002
A074168 003
A074168 004
A074084 001
A074084 002
A074067 001
A074067 002
A074067 003
A074067 004
Mar 31, 1993
Mar 31, 1993
Mar 31, 1993
Mar 31, 1993
Nov 05, 1992
Nov 05, 1992
Nov 05, 1992
Nov 05, 1992
Mar 03, 1995
Mar 03, 1995
Mar 03, 1995
Mar 03, 1995
Feb 25, 1994
Feb 25, 1994
Nov 05, 1992
Nov 05, 1992
Nov 05, 1992
Nov 05, 1992
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
DILTIAZEM MALATE
TABLET, EXTENDED RELEASE;ORAL
TIAMATE
MERCK EQ 120MG HCL
EQ 180MG HCL
EQ 240MG HCL
DILTIAZEM MALATE; ENALAPRIL MALEATE
TABLET, EXTENDED RELEASE;ORAL
TECZEM
BIOVAIL
DIMENHYDRINATE
INJECTABLE;INJECTION
DIMENHYDRINATE
BAXTER HLTHCARE
WATSON LABS
WYETH AYERST
LIQUID;ORAL
DIMENHYDRINATE
ALRA
TABLET;ORAL
DIMENHYDRINATE
HEATHER
NEXGEN PHARMA INC
WATSON LABS
DIMYRISTOYL LECITHIN; PERFLEXANE
INJECTABLE;INTRAVENOUS
IMAGENT
IMCOR PHARMS CO
DINOPROST TROMETHAMINE
INJECTABLE;INJECTION
PROSTIN F2 ALPHA
PHARMACIA AND UPJOHN
DIPHEMANIL METHYLSULFATE
TABLET;ORAL
PRANTAL
SCHERING
DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE;ORAL
BENADRYL
MCNEIL CONS
DIPHENHYDRAMINE HYDROCHLORIDE
ALRA 25MG
ANABOLIC
ELKINS SINN
50MG
50MG
25MG
HALSEY
HEATHER
50MG
50MG
25MG
IMPAX LABS
50MG
25MG
50MG
IVAX SUB TEVA PHARMS
LANNETT
25MG
50MG
25MG
LEDERLE
50MG
25MG
50MG
LNK
MK LABS
25MG
50MG
25MG
MUTUAL PHARM
50MG
25MG
25MG
NEWTRON PHARMS
50MG
25MG
50MG
NEXGEN PHARMA INC 25MG
EQ 180MG HCL;5MG
50MG/ML
50MG/ML
50MG/ML
50MG/ML
12.5MG/4ML
50MG
50MG
50MG
0.92MG/VIAL;0.092MG/VIAL
EQ 5MG BASE/ML
100MG
25MG
50MG
6-106( of 322)
N020506 001 Oct 04, 1996
N020506 002 Oct 04, 1996
N020506 003 Oct 04, 1996
N020507 001 Oct 04, 1996
A084767 001
A080615 001
A083531 001
A084316 001
A080715 001
A080841 001
A085985 001
A085166 001
N021191 001 May 31, 2002
N017434 001
N008114 004
N005845 007
N005845 001
A080519 004
A080519 003
A083275 001
A085701 001
A085701 002
A087914 001 Jun 04, 1984
A084524 001
A083953 001
A080807 001
A080807 002
A080762 001
A080762 002
A080868 001
A080868 002
A086874 001
A086875 001
A087977 001 Jan 27, 1983
A087978 001 Jan 27, 1983
A083087 001
A083087 002
A084506 001
A089488 001 Jan 02, 1987
A089489 001 Jan 02, 1987
A086543 001
A086544 001
A083634 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE;ORAL
DIPHENHYDRAMINE HYDROCHLORIDE
PERRIGO
PIONEER PHARMS
PUREPAC PHARM
PVT FORM
ROXANE
SANDOZ
SUPERPHARM
TEVA
VALEANT PHARM INTL
VANGARD
WATSON LABS
WEST WARD
WHITEWORTH TOWN PLSN
ELIXIR;ORAL
BELIX
HALSEY
BENADRYL
MCNEIL CONS
DIBENIL
CENCI
DIPHEN
USL PHARMA
DIPHENHYDRAMINE HYDROCHLORIDE
BUNDY
CENCI
KV PHARM
LANNETT
LEDERLE
MK LABS
NASKA
PERRIGO
PUREPAC PHARM
PVT FORM
ROXANE
HYDRAMINE
ALPHARMA US PHARMS
INJECTABLE;INJECTION
BENADRYL
MCNEIL CONS
BENADRYL PRESERVATIVE FREE
MCNEIL CONS
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
50MG
25MG
25MG
50MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG
25MG
50MG
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
DIPHENHYDRAMINE HYDROCHLORIDE
BEL MAR 10MG/ML
HIKMA MAPLE 50MG/ML
LYPHOMED 10MG/ML
WATSON LABS 10MG/ML
WATSON LABS INC 10MG/ML
50MG/ML
WYETH AYERST 50MG/ML
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
ABRAXIS PHARM 50MG/ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
10MG/ML
50MG/ML
50MG/ML
6-107( of 322)
A083061 001
A083061 002
A089101 001 Dec 20, 1985
A088880 001 Dec 20, 1985
A085156 001
A085150 001
A083027 001
A083027 002
A080635 001
A080832 001
A080845 002
A080832 002
A080845 001
A089040 001 May 15, 1985
A089041 001 May 15, 1985
A085874 001
A085874 002
A080596 001
A080592 001
A088034 001 Oct 27, 1982
A087630 001
A080728 001
A083797 001
A085138 001
A080727 001
A083797 002
A085083 001
A083567 001
A083441 001
A080800 001
A086586 001 Oct 03, 1983
N005845 004
A088304 001 Dec 16, 1983
A084640 001
A083674 001
A087941 001 Dec 17, 1982
A085621 001
A080939 002
A086937 001
A083088 002
A088680 001 May 31, 1985
A083063 001
A083237 001 Jan 25, 1982
A085287 001
A080643 001
A080763 002
N006146 001
N006146 002
N009486 001
A080822 001
A083183 001
A087066 001
A083533 001
A080873 001
A080873 002
A080577 001
A080586 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
DIPHENHYDRAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
WATSON LABS INC 50MG/ML
SYRUP;ORAL
ANTITUSSIVE
PERRIGO 12.5MG/5ML
BELDIN
HALSEY 12.5MG/5ML
BENYLIN
PARKE DAVIS 12.5MG/5ML
DIPHEN
MORTON GROVE 12.5MG/5ML
DIPHENHYDRAMINE HYDROCHLORIDE
ALPHARMA US PHARMS
CUMBERLAND SWAN
HI TECH PHARMA
HYDRAMINE
ALPHARMA US PHARMS
SILPHEN
SILARX
VICKS FORMULA 44
WARNER CHILCOTT
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
DIPHENHYDRAMINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
SOLUTION;ORAL
BENYLIN
PARKE DAVIS
DIPHENIDOL HYDROCHLORIDE
TABLET;ORAL
VONTROL
GLAXOSMITHKLINE
DIPHENYLPYRALINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
HISPRIL
GLAXOSMITHKLINE
DIPIVEFRIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
DIPIVEFRIN HYDROCHLORIDE
BAUSCH AND LOMB
DIPYRIDAMOLE
INJECTABLE;INJECTION
DIPYRIDAMOLE
AGILA SPECLTS
HOSPIRA
TEVA PHARMS USA
IV PERSANTINE
BOEHRINGER INGELHEIM
TABLET;ORAL
DIPYRIDAMOLE
PROSAM LABS
PUREPAC PHARM
SANDOZ
DIRITHROMYCIN
TABLET, DELAYED RELEASE;ORAL
DYNABAC
LILLY RES LABS
DISOPYRAMIDE PHOSPHATE
CAPSULE;ORAL
DISOPYRAMIDE PHOSPHATE
INTERPHARM
IVAX SUB TEVA PHARMS
MUTUAL PHARM
12.5MG/5ML;30MG/5ML
EQ 25MG BASE
5MG
0.1%
5MG/ML
5MG/ML
5MG/ML
5MG/ML
25MG
50MG
75MG
50MG
75MG
25MG
50MG
75MG
250MG
EQ 100MG BASE
EQ 150MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 100MG BASE
6-108( of 322)
A080873 003
A071292 001 Apr 10, 1987
A089179 001 Jun 05, 1986
N006514 004
A070118 001 Oct 01, 1985
A070497 001 Apr 25, 1989
A073611 001 Aug 20, 1992
A072416 001 Sep 28, 1990
A070205 001 Jan 28, 1986
A072646 001 Feb 27, 1992
A070524 001 Jan 14, 1987
N019014 001 Jun 11, 1985
N016033 001
N011945 001
A074188 001 May 19, 1995
A075769 001 Nov 27, 2002
A074601 001 Dec 19, 1997
A074952 001 Nov 26, 1997
N019817 001 Dec 13, 1990
A040542 001 Apr 21, 2006
A040542 002 Apr 21, 2006
A040542 003 Apr 21, 2006
A089426 001 Jul 12, 1990
A089427 001 Jul 12, 1990
A086944 002 Apr 16, 1991
A087562 001 Feb 25, 1992
A087561 001 Feb 25, 1992
N050678 001 Jun 19, 1995
A071190 001 Jan 15, 1987
A071191 001 Jan 15, 1987
A070186 001 Nov 18, 1985
A070187 001 Nov 18, 1985
A070351 001 Dec 17, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-109( of 322)
DISOPYRAMIDE PHOSPHATE
CAPSULE;ORAL
DISOPYRAMIDE PHOSPHATE
EQ 150MG BASE A070352 001 Dec 17, 1985
MYLAN EQ 100MG BASE A070138 001 Jun 14, 1985
EQ 150MG BASE A070139 001 Jun 14, 1985
SANDOZ EQ 100MG BASE A070470 001 Dec 10, 1985
EQ 150MG BASE A070471 001 Dec 10, 1985
SUPERPHARM EQ 100MG BASE A070940 001 Feb 09, 1987
EQ 150MG BASE A070941 001 Feb 09, 1987
WATSON LABS EQ 100MG BASE A070240 001 Feb 02, 1986
EQ 150MG BASE A070241 001 Feb 02, 1986
CAPSULE, EXTENDED RELEASE;ORAL
DISOPYRAMIDE PHOSPHATE
NESHER PHARMS EQ 150MG BASE A071200 001 Dec 15, 1987
DISULFIRAM
TABLET;ORAL
ANTABUSE
TEVA WOMENS 250MG N007883 003
500MG N007883 002
DISULFIRAM
PAR PHARM 250MG A088792 001 Aug 14, 1984
500MG A088793 001 Aug 14, 1984
WATSON LABS 250MG A086889 001
250MG A087973 001 Aug 05, 1983
500MG A086890 001
500MG A087974 001 Aug 05, 1983
DIVALPROEX SODIUM
TABLET, DELAYED RELEASE;ORAL
DEPAKOTE CP
ABBOTT EQ 250MG BASE N019794 001 Jul 11, 1990
EQ 500MG BASE N019794 002 Jul 11, 1990
DIVALPROEX SODIUM
MYLAN EQ 125MG VALPROIC ACID A077254 001 Jul 29, 2008
EQ 250MG VALPROIC ACID A077254 002 Jul 29, 2008
EQ 500MG VALPROIC ACID A077254 003 Jul 29, 2008
TABLET, EXTENDED RELEASE;ORAL
DIVALPROEX SODIUM
TEVA PHARMS USA EQ 500MG VALPROIC ACID A078700 001 Aug 03, 2009
DOBUTAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOBUTAMINE HYDROCHLORIDE
ASTRAZENECA EQ 12.5MG BASE/ML A074098 001 Feb 21, 1995
BAXTER HLTHCARE EQ 12.5MG BASE/ML A074381 001 Sep 26, 1996
HOSPIRA EQ 1.25GM BASE/100ML A074634 001 Sep 27, 1996
LUITPOLD EQ 12.5MG BASE/ML A074545 001 Jun 25, 1998
MARSAM PHARMS LLC EQ 12.5MG BASE/ML A074279 001 Feb 18, 1998
EQ 12.5MG BASE/ML A074995 001 Mar 31, 1998
TEVA PARENTERAL EQ 12.5MG BASE/ML A074206 001 Oct 19, 1993
DOBUTREX
LILLY EQ 12.5MG BASE/ML N017820 002
DOCETAXEL
INJECTABLE;INJECTION
DOCETAXEL
APOTEX INC 20MG/0.5ML (40MG/ML) N022312 001 Jan 11, 2012
80MG/2ML (40MG/ML) N022312 002 Jan 11, 2012
TAXOTERE
SANOFI AVENTIS US 40MG/ML **Federal Register N020449 001 May 14, 1996
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
DONEPEZIL HYDROCHLORIDE
SOLUTION;ORAL
ARICEPT
EISAI INC 5MG/5ML N021719 001 Oct 18, 2004
TABLET;ORAL
DONEPEZIL HYDROCHLORIDE
ACCORD HLTHCARE 5MG A201335 001 Aug 29, 2011
10MG A201335 002 Aug 29, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-110( of 322)
DONEPEZIL HYDROCHLORIDE
TABLET, ORALLY DISINTEGRATING;ORAL
DONEPEZIL HYDROCHLORIDE
MUTUAL PHARM 5MG A077975 002 Dec 11, 2009
10MG A077975 001 Dec 11, 2009
DOPAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOPAMINE HYDROCHLORIDE
ABBOTT 40MG/ML A070656 001 Jan 24, 1989
80MG/ML A070657 001 Jan 24, 1989
ABRAXIS PHARM 40MG/ML A070012 001 Jun 12, 1985
40MG/ML A070058 001 Mar 20, 1985
80MG/ML A070013 001 Jun 12, 1985
80MG/ML A070059 001 Mar 20, 1985
160MG/ML A070364 001 Dec 04, 1985
ASTRAZENECA 40MG/ML A070087 001 Oct 23, 1985
40MG/ML N018656 001 Jun 28, 1983
80MG/ML A070089 001 Oct 23, 1985
80MG/ML A070090 001 Oct 23, 1985
80MG/ML A070091 001 Oct 23, 1985
160MG/ML A070092 001 Oct 23, 1985
160MG/ML A070093 001 Oct 23, 1985
160MG/ML A070094 001 Oct 23, 1985
BAXTER HLTHCARE 40MG/ML N018398 001
80MG/ML N018398 002 Mar 22, 1982
HOSPIRA 40MG/ML A074403 001 May 23, 1996
INTL MEDICATION 40MG/ML N018014 001
LYPHOMED 40MG/ML N018549 001 Mar 11, 1983
SMITH AND NEPHEW 40MG/ML A070011 001 Aug 29, 1985
40MG/ML A070046 001 Aug 29, 1985
80MG/ML A070047 001 Aug 29, 1985
TEVA PARENTERAL 40MG/ML A072999 001 Oct 23, 1991
80MG/ML A073000 001 Oct 23, 1991
WARNER CHILCOTT 40MG/ML A070558 001 Sep 20, 1985
40MG/ML N018138 001
80MG/ML A070559 001 Sep 20, 1985
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%
HOSPIRA 1.6MG/ML N020542 001 Aug 30, 1995
INTROPIN
HOSPIRA 40MG/ML N017395 001
80MG/ML N017395 002
160MG/ML N017395 003
DORZOLAMIDE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
DORZOLAMIDE HYDROCHLORIDE
APOTEX INC EQ 2% BASE A078395 001 Oct 28, 2008
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
APOTEX INC EQ 2% BASE;EQ 0.5% BASE A078201 001 Oct 28, 2008
DOXACURIUM CHLORIDE
INJECTABLE;INJECTION
NUROMAX
ABBVIE EQ 1MG BASE/ML N019946 001 Mar 07, 1991
DOXAZOSIN MESYLATE
TABLET;ORAL
DOXAZOSIN MESYLATE
ACTAVIS ELIZABETH EQ 1MG BASE A075574 001 Oct 18, 2000
EQ 2MG BASE A075574 002 Oct 18, 2000
EQ 4MG BASE A075574 003 Oct 18, 2000
EQ 8MG BASE A075574 004 Oct 18, 2000
GENPHARM EQ 1MG BASE A075466 001 Oct 18, 2000
EQ 2MG BASE A075466 002 Oct 18, 2000
EQ 4MG BASE A075466 003 Oct 18, 2000
EQ 8MG BASE A075466 004 Oct 18, 2000
IVAX SUB TEVA PHARMS EQ 1MG BASE A075453 001 Oct 18, 2000
EQ 2MG BASE A075453 002 Oct 18, 2000
EQ 4MG BASE A075453 003 Oct 18, 2000
EQ 8MG BASE A075453 004 Oct 18, 2000
NESHER PHARMS EQ 1MG BASE A075609 001 Oct 18, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DOXAZOSIN MESYLATE
TABLET;ORAL
DOXAZOSIN MESYLATE
SANDOZ
TEVA
WATSON LABS INC
DOXEPIN HYDROCHLORIDE
CAPSULE;ORAL
DOXEPIN HYDROCHLORIDE
DAVA PHARMS INC
MUTUAL PHARM
NEW RIVER
PAR PHARM
PUREPAC PHARM
QUANTUM PHARMICS
SANDOZ
WATSON LABS
DISCONTINUED DRUG PRODUCT LIST
EQ 2MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 1MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 8MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 25MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 50MG BASE
EQ 50MG BASE
6-111( of 322)
A075609 002 Oct 18, 2000
A075609 003 Oct 18, 2000
A075609 004 Oct 18, 2000
A075432 001 Oct 18, 2000
A075646 001 Oct 18, 2000
A075432 002 Oct 18, 2000
A075646 002 Oct 18, 2000
A075432 003 Oct 18, 2000
A075646 003 Oct 18, 2000
A075432 004 Oct 18, 2000
A075646 004 Oct 18, 2000
A075353 001 Jan 12, 2001
A075353 002 Jan 12, 2001
A075353 003 Jan 12, 2001
A075353 004 Jan 12, 2001
A075426 001 Oct 18, 2000
A075426 002 Oct 18, 2000
A075426 003 Oct 18, 2000
A075426 004 Oct 18, 2000
A071685 001 Jan 05, 1988
A071686 001 Jan 05, 1988
A071673 001 Jan 05, 1988
A071674 001 Jan 05, 1988
A071675 001 Jan 05, 1988
A071676 001 Jan 05, 1988
A071502 001 Feb 18, 1988
A071653 001 Feb 18, 1988
A071654 001 Feb 18, 1988
A071521 001 Feb 18, 1988
N016987 001
N016987 002
N016987 003
N016987 006
N016987 004
N016987 007 Apr 13, 1987
A071697 001 Nov 09, 1987
A071437 001 Nov 09, 1987
A071595 001 Nov 09, 1987
A071608 001 Nov 09, 1987
A071422 001 Nov 09, 1987
A073054 001 Dec 28, 1990
A072109 001 Dec 28, 1990
A073055 001 Dec 28, 1990
A072386 001 Sep 08, 1988
A072110 001 Sep 08, 1988
A072387 001 Sep 08, 1988
A070972 001 Sep 29, 1987
A070973 001 Sep 29, 1987
A070931 001 Sep 29, 1987
A070932 001 Sep 29, 1987
A072375 001 Mar 15, 1989
A072376 001 Mar 15, 1989
A071487 001 Mar 02, 1987
A070827 001 May 15, 1986
A070828 001 May 15, 1986
A070825 001 May 15, 1986
A071562 001 Mar 02, 1987
A070952 001 Mar 04, 1987
A071485 001 Apr 30, 1987
A072985 001 Mar 29, 1991
A070953 001 May 15, 1986
A071486 001 Apr 30, 1987
A072986 001 Mar 29, 1991
A070954 001 May 15, 1986
A071238 001 Apr 30, 1987
A072987 001 Mar 29, 1991
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-112( of 322)
DOXEPIN HYDROCHLORIDE
CAPSULE;ORAL
DOXEPIN HYDROCHLORIDE
EQ 75MG BASE A071326 001 Apr 30, 1987
EQ 75MG BASE A071763 001 Feb 09, 1988
EQ 100MG BASE A070955 001 May 15, 1986
EQ 100MG BASE A071239 001 Apr 30, 1987
EQ 150MG BASE A071764 001 Feb 09, 1988
SINEQUAN
PFIZER EQ 10MG BASE N016798 003
EQ 25MG BASE N016798 001
EQ 50MG BASE N016798 002
EQ 75MG BASE N016798 006
EQ 100MG BASE N016798 005
EQ 150MG BASE **Federal Register N016798 007
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
CONCENTRATE;ORAL
DOXEPIN HYDROCHLORIDE
PHARM ASSOC EQ 10MG BASE/ML A075924 001 Jan 15, 2004
SINEQUAN
PFIZER EQ 10MG BASE/ML N017516 001
DOXORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
ADRIAMYCIN PFS
PHARMACIA AND UPJOHN 2MG/ML A063165 001 Jan 30, 1991
2MG/ML N050629 001 Dec 23, 1987
200MG/100ML A063165 002 Jan 30, 1991
200MG/100ML N050629 002 May 03, 1988
ADRIAMYCIN RDF
PHARMACIA AND UPJOHN 10MG/VIAL N050467 001
20MG/VIAL N050467 003 May 20, 1985
50MG/VIAL N050467 002
150MG/VIAL N050467 004 Jul 22, 1987
RUBEX
BRISTOL MYERS SQUIBB 10MG/VIAL A062926 001 Apr 13, 1989
50MG/VIAL A062926 002 Apr 13, 1989
100MG/VIAL A062926 003 Apr 13, 1989
DOXYCYCLINE
CAPSULE;ORAL
DOXYCYCLINE
PAR PHARM EQ 75MG BASE A065055 004 Apr 18, 2005
SANDOZ INC EQ 50MG BASE A065032 001 Jun 30, 2000
EQ 100MG BASE A065032 002 Jun 30, 2000
FOR SUSPENSION;ORAL
DOXYCHEL
RACHELLE EQ 25MG BASE/5ML A061720 001
TABLET;ORAL
DOXYCYCLINE
MUTUAL PHARM EQ 50MG BASE A065471 001 Apr 17, 2009
EQ 75MG BASE A065471 002 Apr 17, 2009
EQ 100MG BASE A065471 003 Apr 17, 2009
SANDOZ INC EQ 50MG BASE A065353 001 Nov 27, 2006
EQ 75MG BASE A065353 002 Nov 27, 2006
EQ 100MG BASE A065353 003 Nov 27, 2006
DOXYCYCLINE HYCLATE
CAPSULE;ORAL
DOXY-LEMMON
TEVA EQ 50MG BASE A062497 001 Aug 23, 1984
EQ 100MG BASE A062497 002 Jun 15, 1984
DOXYCYCLINE HYCLATE
HALSEY EQ 50MG BASE A062119 002 May 24, 1985
EQ 100MG BASE A062119 001 May 24, 1985
HEATHER EQ 50MG BASE A062463 001 Dec 07, 1983
EQ 100MG BASE A062463 002 Dec 07, 1983
INTERPHARM EQ 50MG BASE A062763 001 Sep 02, 1988
EQ 100MG BASE A062763 002 Sep 02, 1988
MUTUAL PHARM EQ 50MG BASE A062418 001 Jan 28, 1983
EQ 100MG BASE A062418 002 Jan 28, 1983
MYLAN EQ 50MG BASE A062337 001 Mar 29, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
DOXYCYCLINE HYCLATE
CAPSULE;ORAL
DOXYCYCLINE HYCLATE
EQ 100MG BASE
PAR PHARM EQ 50MG BASE
EQ 100MG BASE
PVT FORM EQ 50MG BASE
EQ 100MG BASE
RANBAXY EQ 50MG BASE
EQ 100MG BASE
SUPERPHARM EQ 50MG BASE
EQ 100MG BASE
WARNER CHILCOTT EQ 50MG BASE
EQ 100MG BASE
WATSON LABS EQ 50MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 100MG BASE
PERIOSTAT
COLLAGENEX EQ 20MG BASE
CAPSULE, COATED PELLETS;ORAL
DOXYCYCLINE HYCLATE
PLIVA EQ 100MG BASE
CAPSULE, DELAYED RELEASE;ORAL
DORYX
MAYNE PHARMA INTL EQ 75MG BASE
EQ 100MG BASE
WARNER CHILCOTT EQ 100MG BASE
INJECTABLE;INJECTION
DOXYCHEL HYCLATE
RACHELLE EQ 100MG BASE/VIAL
DOXYCYCLINE
BEDFORD EQ 200MG BASE/VIAL
HIKMA MAPLE EQ 100MG BASE/VIAL
EQ 200MG BASE/VIAL
DOXYCYCLINE HYCLATE
HIKMA MAPLE EQ 100MG BASE/VIAL
EQ 200MG BASE/VIAL
VIBRAMYCIN
PFIZER EQ 100MG BASE/VIAL
EQ 200MG BASE/VIAL
TABLET;ORAL
DOXY-LEMMON
TEVA EQ 100MG BASE
DOXYCYCLINE HYCLATE
BLU CARIBE INC EQ 50MG BASE
HEATHER EQ 100MG BASE
INTERPHARM EQ 100MG BASE
MUTUAL PHARM EQ 100MG BASE
MYLAN EQ 100MG BASE
SUPERPHARM EQ 100MG BASE
WARNER CHILCOTT EQ 100MG BASE
WATSON LABS EQ 50MG BASE
EQ 100MG BASE
VIBRA-TABS
PFIZER EQ 100MG BASE
DOXYLAMINE SUCCINATE
CAPSULE;ORAL
UNISOM
PFIZER 25MG
TABLET;ORAL
DECAPRYN
SANOFI AVENTIS US 12.5MG
25MG
DOXY-SLEEP-AID
PAR PHARM 25MG
DOXYLAMINE SUCCINATE
COPLEY PHARM 25MG
QUANTUM PHARMICS 25MG
6-113( of 322)
A062337 002 Mar 29, 1982
A062434 001 Oct 19, 1984
A062442 001 Dec 22, 1983
A062631 001 Jul 24, 1986
A062631 002 Jul 24, 1986
A062479 001 Dec 23, 1983
A062479 002 Dec 23, 1983
A062469 001 Oct 31, 1984
A062469 002 Oct 31, 1984
A062594 001 Dec 05, 1985
A062594 002 Dec 05, 1985
A061717 001
A062142 001
A061717 002
A062142 002
N050744 001 Sep 30, 1998
A063187 001 Jun 30, 1992
N050582 002 Aug 13, 2001
N050582 001 Jul 22, 1985
A062653 001 Oct 30, 1985
A061953 001
A062569 002 Mar 09, 1988
A062450 001 Oct 27, 1983
A062450 002 Oct 27, 1983
A062992 001 Feb 16, 1989
A062992 002 Feb 16, 1989
N050442 002
N050442 001
A062581 001 Mar 15, 1985
A062269 003
A062462 001 May 11, 1983
A062764 001 Sep 02, 1988
A062391 001 Sep 30, 1982
A062432 001 Feb 15, 1983
A062494 001 Feb 20, 1985
A062593 001 Aug 28, 1985
A062392 001 Mar 31, 1983
A062392 002 Mar 31, 1983
N050533 001
N019440 001 Feb 05, 1986
N006412 015
N006412 014
A070156 001 Jul 02, 1987
A088900 002 Feb 12, 1988
A088603 001 Aug 07, 1984
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-114( of 322)
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
BENDECTIN
SANOFI AVENTIS US 10MG;10MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
N010598 002
DROMOSTANOLONE PROPIONATE
INJECTABLE;INJECTION
DROLBAN
LILLY 50MG/ML N012936 001
DROPERIDOL
INJECTABLE;INJECTION
DROPERIDOL
ABRAXIS PHARM
ASTRAZENECA
HOSPIRA
LUITPOLD
SMITH AND NEPHEW
SOLOPAK
WATSON LABS
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML
A070992 001
A070993 001
A072018 001
A072019 001
A072020 001
A072021 001
A071645 001
A072272 001
A072335 001
A071750 001
A071754 001
A071755 001
A073520 001
A073521 001
A073523 001
Nov 17, 1986
Nov 17, 1986
Oct 20, 1988
Oct 19, 1988
Oct 19, 1988
Oct 19, 1988
Apr 07, 1988
Aug 31, 1995
Oct 24, 1988
Sep 06, 1988
Sep 06, 1988
Sep 06, 1988
Nov 27, 1991
Nov 27, 1991
Nov 27, 1991
DROPERIDOL; FENTANYL CITRATE
INJECTABLE;INJECTION
FENTANYL CITRATE AND DROPERIDOL
ASTRAZENECA
HOSPIRA
INNOVAR
2.5MG/ML;EQ 0.05MG BASE/ML
2.5MG/ML;EQ 0.05MG BASE/ML
2.5MG/ML;EQ 0.05MG BASE/ML
2.5MG/ML;EQ 0.05MG BASE/ML
A072026 001
A072027 001
A072028 001
A071982 001
Apr 13, 1989
Apr 13, 1989
Apr 13, 1989
May 04, 1988
AKORN MFG 2.5MG/ML;EQ 0.05MG BASE/ML N016049 001
DYCLONINE HYDROCHLORIDE
SOLUTION;TOPICAL
DYCLONE
ASTRAZENECA 0.5% **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N009925 002
1% **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N009925 001
DYDROGESTERONE
TABLET;ORAL
GYNOREST
SOLVAY 5MG N017388 001
10MG N017388 002
DYPHYLLINE
ELIXIR;ORAL
NEOTHYLLINE
TEVA
INJECTABLE;INJECTION
NEOTHYLLINE
160MG/15ML N007794 003
TEVA
TABLET;ORAL
DILOR
250MG/ML N009088 001
SAVAGE LABS 200MG A084514 001
DILOR-400
SAVAGE LABS 400MG A084751 001
NEOTHYLLINE
TEVA 200MG N007794 001
400MG N007794 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-115( of 322)
ECHOTHIOPHATE IODIDE
FOR SOLUTION;OPHTHALMIC
PHOSPHOLINE IODIDE
WYETH PHARMS INC 0.03% N011963 002
0.06% N011963 004
0.25% N011963 003
ECONAZOLE NITRATE
CREAM;TOPICAL
SPECTAZOLE
ORTHO JANSSEN 1% N018751 001 Dec 23, 1982
EDETATE CALCIUM DISODIUM
TABLET;ORAL
CALCIUM DISODIUM VERSENATE
MEDICIS 500MG N008922 002
EDROPHONIUM CHLORIDE
INJECTABLE;INJECTION
EDROPHONIUM CHLORIDE
HOSPIRA 10MG/ML A040131 001 Feb 24, 1998
WATSON LABS 10MG/ML A040044 001 Mar 20, 1996
EDROPHONIUM CHLORIDE PRESERVATIVE FREE
WATSON LABS 10MG/ML A040043 001 Mar 20, 1996
REVERSOL
ORGANON USA INC 10MG/ML A089624 001 May 13, 1988
EFAVIRENZ
CAPSULE;ORAL
SUSTIVA
BRISTOL MYERS SQUIBB 100MG **Federal Register determination N020972 002 Sep 17, 1998
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
TABLET;ORAL
SUSTIVA
BRISTOL MYERS SQUIBB 300MG **Federal Register determination N021360 001 Feb 01, 2002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
EFLORNITHINE HYDROCHLORIDE
INJECTABLE;INJECTION
ORNIDYL
SANOFI AVENTIS US 200MG/ML N019879 002 Nov 28, 1990
ENALAPRIL MALEATE
TABLET;ORAL
ENALAPRIL MALEATE
APOTHECON 2.5MG A075583 001 Aug 22, 2000
5MG A075583 002 Aug 22, 2000
10MG A075583 003 Aug 22, 2000
20MG A075583 004 Aug 22, 2000
IVAX SUB TEVA PHARMS 2.5MG A075482 001 Aug 22, 2000
5MG A075482 002 Aug 22, 2000
10MG A075482 003 Aug 22, 2000
20MG A075482 004 Aug 22, 2000
KRKA DD NOVO MESTO 2.5MG A075370 001 Aug 22, 2000
5MG A075370 002 Aug 22, 2000
10MG A075369 001 Aug 22, 2000
20MG A075369 002 Aug 22, 2000
MYLAN 2.5MG A075472 001 Aug 22, 2000
5MG A075472 002 Aug 22, 2000
10MG A075472 003 Aug 22, 2000
20MG A075472 004 Aug 22, 2000
RANBAXY 2.5MG A075556 001 Aug 22, 2000
5MG A075556 002 Aug 22, 2000
10MG A075556 003 Aug 22, 2000
20MG A075556 004 Aug 22, 2000
SANDOZ 2.5MG A075048 001 Aug 22, 2000
5MG A075048 002 Aug 22, 2000
10MG A075048 003 Aug 22, 2000
20MG A075048 004 Aug 22, 2000
SANDOZ INC 2.5MG A075496 001 Aug 22, 2000
2.5MG A075621 001 Aug 22, 2000
5MG A075496 002 Aug 22, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-116( of 322)
ENALAPRIL MALEATE
TABLET;ORAL
ENALAPRIL MALEATE
5MG A075621 002 Aug 22, 2000
10MG A075459 001 Aug 22, 2000
10MG A075621 003 Aug 22, 2000
20MG A075459 002 Aug 22, 2000
20MG A075621 004 Aug 22, 2000
ENALAPRIL MALEATE; FELODIPINE
TABLET, EXTENDED RELEASE;ORAL
LEXXEL
ASTRAZENECA 5MG;2.5MG N020668 002 Oct 28, 1998
5MG;5MG N020668 001 Dec 27, 1996
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
IVAX SUB TEVA PHARMS 5MG;12.5MG A075736 001 Mar 25, 2003
10MG;25MG A075736 002 Mar 25, 2003
SANDOZ INC 5MG;12.5MG A076116 001 Sep 19, 2001
10MG;25MG A076116 002 Sep 19, 2001
ENALAPRILAT
INJECTABLE;INJECTION
ENALAPRILAT
HOSPIRA 1.25MG/ML A075456 001 Aug 22, 2000
1.25MG/ML A075571 001 Aug 22, 2000
VASOTEC
BIOVAIL LABS INTL 1.25MG/ML N019309 001 Feb 09, 1988
ENFLURANE
LIQUID;INHALATION
ENFLURANE
ABBOTT 99.9% A070803 001 Sep 08, 1987
ENOXACIN
TABLET;ORAL
PENETREX
SANOFI AVENTIS US 200MG N019616 004 Dec 31, 1991
400MG N019616 005 Dec 31, 1991
ENOXAPARIN SODIUM
INJECTABLE;SUBCUTANEOUS
LOVENOX (PRESERVATIVE FREE)
SANOFI AVENTIS US 90MG/0.6ML (150MG/ML) **Federal N020164 006 Jun 02, 2000
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
EPINEPHRINE
AEROSOL, METERED;INHALATION
BRONKAID MIST
STERLING 0.25MG/INH N016803 001
EPINEPHRINE
ARMSTRONG PHARMS 0.2MG/INH A087907 001 May 23, 1984
PRIMATENE MIST
WYETH CONS 0.2MG/INH N016126 001
INJECTABLE;INJECTION
SUS-PHRINE SULFITE-FREE
FOREST LABS 1.5MG/AMP N007942 003 Feb 05, 1999
5MG/ML N007942 001
INJECTABLE;INTRAMUSCULAR
EPI E Z PEN JR
MYLAN SPECLT 0.15MG/DELIVERY N019430 004 Aug 03, 1995
EPIPEN E Z PEN
MYLAN SPECLT 0.3MG/DELIVERY N019430 003 Aug 03, 1995
EPINEPHRINE BITARTRATE
AEROSOL, METERED;INHALATION
BRONITIN MIST
WYETH CONS 0.3MG/INH N016126 002
MEDIHALER-EPI
3M 0.3MG/INH N010374 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
DURANEST
ASTRAZENECA 0.005MG/ML;1%
0.005MG/ML;1.5%
DENTSPLY PHARM 0.005MG/ML;1.5%
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CITANEST FORTE
ASTRAZENECA 0.005MG/ML;4%
EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
DURANEST
ASTRAZENECA 0.005MG/ML;0.5%
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE
CARLISLE 0.01MG/ML;2%
0.02MG/ML;2%
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
GRAHAM CHEM 0.01MG/ML;2%
0.02MG/ML;2%
HIKMA MAPLE 0.01MG/ML;1%
0.01MG/ML;2%
HOSPIRA 0.005MG/ML;1%
0.005MG/ML;1.5%
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
ABBOTT
BEL MAR
DELL LABS
INTL MEDICATION
WATSON LABS
LIDOCATON
PHARMATON
XYLOCAINE DENTAL WITH EPINEPHRINE
DENTSPLY PHARM
XYLOCAINE W/ EPINEPHRINE
ASTRAZENECA
FRESENIUS KABI USA
PATCH;IONTOPHORESIS, TOPICAL
LIDOSITE TOPICAL SYSTEM KIT
VYTERIS
SOLUTION;IONTOPHORESIS
IONTOCAINE
IOMED
0.01MG/ML;1%
0.01MG/ML;1%
0.01MG/ML;2%
0.01MG/ML;1%
0.01MG/ML;2%
0.01MG/ML;1%
0.01MG/ML;1%
0.01MG/ML;1%
0.01MG/ML;2%
0.01MG/ML;2%
0.02MG/ML;2%
SOLUTION;IONTOPHORESIS, TOPICAL
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
EMPI 0.01MG/ML;2%
EPINEPHRINE; PROCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
PROCAINE HYDROCHLORIDE W/ EPINEPHRINE
BEL MAR
EPIRUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
EPIRUBICIN HYDROCHLORIDE
MYLAN INSTITUTIONAL
INJECTABLE;IV (INFUSION)
EPIRUBICIN HYDROCHLORIDE
HOSPIRA
0.01MG/ML;2%
0.02MG/ML;2%
0.005MG/ML;1%
0.005MG/ML;1.5%
0.005MG/ML;2%
0.01MG/ML;2%
1.05MG/PATCH;100MG/PATCH
0.01MG/ML;2%
0.02MG/ML;1%
0.02MG/ML;2%
50MG/25ML (2MG/ML)
200MG/100ML (2MG/ML)
200MG/VIAL
6-117( of 322)
N017751 006
N017751 007
N021384 001
N014763 008
N017751 004
A084720 001
A084732 001
A080504 004 Oct 19, 1983
A080504 005 Oct 19, 1983
A080406 001
A080406 002
A089649 001 Jun 21, 1988
A089650 001 Jun 21, 1988
A083154 001
A080820 001
A080757 001
A083389 001
A083390 001
A086402 001
A080377 003
A085463 001
A080377 004
A084729 001 Aug 17, 1983
A084728 001 Aug 17, 1983
N021381 001
N021381 002
N010418 006
N010418 010
N010418 008
N006488 003
N021504 001 May 06, 2004
N020530 001 Dec 21, 1995
N021486 001 Oct 26, 2004
A080758 001
A080759 001
A065371 001 Nov 28, 2007
A065371 002 Nov 28, 2007
N050807 002 Sep 15, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
EPLERENONE
TABLET;ORAL
INSPRA
GD SEARLE LLC 100MG
EPROSARTAN MESYLATE
TABLET;ORAL
TEVETEN
ABBVIE EQ 300MG BASE
ERGOCALCIFEROL
CAPSULE;ORAL
DELTALIN
LILLY 50,000 IU
VITAMIN D
CHASE CHEM 50,000 IU
EVERYLIFE 50,000 IU
IMPAX LABS 50,000 IU
LANNETT 50,000 IU
VITARINE 50,000 IU
WEST WARD 50,000 IU
ERGOLOID MESYLATES
CAPSULE;ORAL
HYDERGINE LC
NOVARTIS 1MG
SOLUTION;ORAL
HYDERGINE
NOVARTIS 1MG/ML
TABLET;ORAL
ERGOLOID MESYLATES
MUTUAL PHARM 1MG
WATSON LABS 1MG
1MG
GERIMAL
WATSON LABS 1MG
HYDERGINE
NOVARTIS 0.5MG
TABLET;SUBLINGUAL
ALKERGOT
SANDOZ 0.5MG
1MG
CIRCANOL
3M 0.5MG
1MG
DEAPRIL-ST
BRISTOL MYERS SQUIBB 1MG
ERGOLOID MESYLATES
KV PHARM 0.5MG
0.5MG
1MG
1MG
LEDERLE 0.5MG
1MG
MUTUAL PHARM 0.5MG
1MG
SUPERPHARM 0.5MG
1MG
VANGARD 0.5MG
1MG
WATSON LABS 0.5MG
1MG
1MG
GERIMAL
WATSON LABS 0.5MG
1MG
HYDERGINE
NOVARTIS 0.5MG
1MG
HYDROGENATED ERGOT ALKALOIDS
IVAX PHARMS 0.5MG
1MG
6-118( of 322)
N021437 003 Sep 27, 2002
N020738 004 Dec 22, 1997
A080884 001
A080747 001
A080956 001
A080951 001
A080825 001
A084053 001
A083102 001
N018706 001 Jan 18, 1983
N018418 001
A088891 001 Nov 01, 1985
A086433 001 May 27, 1982
A087244 001 Aug 16, 1982
A088207 001 Mar 22, 1984
N017993 003
A085153 001
A087417 001
A084868 001
A085809 001
A085020 002
A085899 001
A086265 001
A085900 001
A086264 001
A086984 001
A086985 001
A087407 001
A087552 001
A089233 001 Sep 23, 1986
A089234 001 Sep 23, 1986
A088013 001 Sep 20, 1982
A088014 001 Sep 20, 1982
A084930 001
A085177 001
A087183 001
A086189 001
A086188 001
N009087 002
N009087 001
A087186 001
A087185 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ERGOTAMINE TARTRATE
AEROSOL, METERED;INHALATION
MEDIHALER ERGOTAMINE
3M
TABLET;SUBLINGUAL
ERGOSTAT
PARKE DAVIS
WIGRETTES
ORGANON USA INC
ERYTHROMYCIN
0.36MG/INH
2MG
2MG
CAPSULE, DELAYED REL PELLETS;ORAL
ERYC
PARKE DAVIS
WARNER CHILCOTT LLC
ERYC 125
PARKE DAVIS
ERYC SPRINKLES
HOSPIRA
ERYTHROMYCIN
BARR
GEL;TOPICAL
E-GLADES
RENAISSANCE PHARMA
EMGEL
ALTANA
LOTION;TOPICAL
E-SOLVE 2
SYOSSET
OINTMENT;OPHTHALMIC
ERYTHROMYCIN
PHARMADERM
PHARMAFAIR
ILOTYCIN
DISTA
POWDER;FOR RX COMPOUNDING
ERYTHROMYCIN
PADDOCK LLC
SOLUTION;TOPICAL
A/T/S
TARO PHARMS NORTH
ERYDERM
ARBOR PHARMS INC
ERYMAX
MERZ PHARMS
ERYTHROMYCIN
ALPHARMA US PHARMS
BAUSCH AND LOMB
LILLY
PHARMAFAIR
RENAISSANCE PHARMA
SANSAC
DOW PHARM
STATICIN
WESTWOOD SQUIBB
T-STAT
WESTWOOD SQUIBB
SWAB;TOPICAL
C-SOLVE-2
IVAX SUB TEVA PHARMS
ERYCETTE
JOHNSON AND JOHNSON
ERYTHROMYCIN
RENAISSANCE PHARMA
T-STAT
WESTWOOD SQUIBB
250MG
250MG
250MG
125MG
125MG
250MG
2%
2%
2%
5MG/GM
5MG/GM
0.5%
100%
2%
2%
2%
1.5%
2%
2%
2%
2%
2%
2%
1.5%
2%
2%
2%
1.5%
2%
2%
2%
2%
2%
6-119( of 322)
N012102 001
A088337 001 Jun 08, 1984
A086750 001 Jul 29, 1982
A062546 001 Jul 25, 1985
A062618 001 Sep 25, 1985
A062338 001
A062648 001 Oct 24, 1985
N050593 001 Jul 22, 1985
A063098 001 May 04, 1989
A065009 001 Mar 18, 2002
A063107 001 Aug 23, 1991
A062467 001 Jul 03, 1985
A062446 001 Sep 26, 1983
A062481 001 Apr 05, 1984
N050368 001
N050610 001 Nov 07, 1986
A062405 001 Nov 18, 1982
A062290 001
A062508 002 Jul 11, 1985
A062328 001 Apr 19, 1982
A062326 001 Apr 19, 1982
A062327 001 Apr 19, 1982
A062342 001 Feb 25, 1982
A062957 001 Jul 21, 1988
A064039 001 Jan 27, 1994
N050532 001
A062485 001 Jul 11, 1984
A062616 001 Jul 25, 1985
A064127 001 Feb 14, 1997
A062522 001 Jan 24, 1985
N050526 001
A062436 001 Mar 09, 1983
A062751 001 Jul 30, 1993
N050594 001 Feb 15, 1985
A064128 001 Jul 03, 1996
A062748 001 Jul 23, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-120( of 322)
A063028 001 May 15, 1990
A063086 001 May 15, 1990
A062999 001 Nov 25, 1988
A060272 001
A060272 002
A061910 001
A061659 001
A061633 001
A062162 001
A062162 002
A062237 001
A062087 001
A061897 001
A061897 002
A061893 001
A062353 001 Nov 18, 1982
A062409 001 Dec 16, 1982
A062169 001 Oct 17, 1990
A062169 002 Oct 17, 1990
A062362 001 Dec 17, 1982
A061894 001
N050010 001
A061894 002
N050010 002
A061894 003
A061896 001
A061895 001
A061895 002
N050599 001 Sep 29, 1989
A062055 001
A062305 001
A062198 001
A062198 002
A062200 001
A062200 002
A062177 001
A062177 002
A062674 001 Mar 10, 1987
A062231 001
ERYTHROMYCIN
TABLET, DELAYED RELEASE;ORAL
E-BASE
BARR
E-MYCIN
ARBOR PHARMS INC
ILOTYCIN
DISTA
R-P MYCIN
SOLVAY
ROBIMYCIN
ROBINS AH
ERYTHROMYCIN ESTOLATE
CAPSULE;ORAL
ERYTHROMYCIN ESTOLATE
BARR
IVAX SUB TEVA PHARMS
WATSON LABS
ILOSONE
LILLY
FOR SUSPENSION;ORAL
ILOSONE
DISTA
SUSPENSION;ORAL
ERYTHROMYCIN ESTOLATE
ALPHARMA US PHARMS
BARR
LIFE LABS
ILOSONE
LILLY
SUSPENSION/DROPS;ORAL
ILOSONE
LILLY
TABLET;ORAL
ILOSONE
LILLY
TABLET, CHEWABLE;ORAL
ILOSONE
DISTA
ERYTHROMYCIN ESTOLATE; SULFISOXAZOLE ACETYL
333MG
333MG
500MG
250MG
333MG
250MG
250MG
250MG
EQ 125MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 125MG BASE
EQ 250MG BASE
EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
EQ 100MG BASE/ML
EQ 500MG BASE
EQ 125MG BASE
EQ 250MG BASE
SUSPENSION;ORAL
ILOSONE SULFA
LILLY
ERYTHROMYCIN ETHYLSUCCINATE
GRANULE;ORAL
ERYTHROMYCIN ETHYLSUCCINATE
BARR
PEDIAMYCIN
ROSS LABS
SUSPENSION;ORAL
E-MYCIN E
PHARMACIA AND UPJOHN
ERYTHROMYCIN ETHYLSUCCINATE
ALPHARMA US PHARMS
DISTA
NASKA
PARKE DAVIS
EQ 125MG BASE/5ML;EQ 600MG BASE/5ML
EQ 200MG BASE/5ML
EQ 200MG BASE/5ML
EQ 200MG BASE/5ML
EQ 400MG BASE/5ML
EQ 200MG BASE/5ML
EQ 400MG BASE/5ML
EQ 200MG BASE/5ML
EQ 400MG BASE/5ML
EQ 400MG BASE/5ML
EQ 200MG BASE/5ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ERYTHROMYCIN ETHYLSUCCINATE
SUSPENSION;ORAL
ERYTHROMYCIN ETHYLSUCCINATE
PHARMAFAIR
WYAMYCIN E
WYETH AYERST
SUSPENSION/DROPS;ORAL
PEDIAMYCIN
ROSS LABS
TABLET;ORAL
E.E.S. 400
ARBOR PHARMS INC
ERYTHROMYCIN ETHYLSUCCINATE
BARR
MYLAN
TABLET, CHEWABLE;ORAL
E.E.S.
ARBOR PHARMS INC
ERYPED
ARBOR PHARMS INC
PEDIAMYCIN
ROSS LABS
EQ 400MG BASE/5ML
EQ 200MG BASE/5ML
EQ 400MG BASE/5ML
EQ 200MG BASE/5ML
EQ 400MG BASE/5ML
EQ 100MG BASE/2.5ML
EQ 400MG BASE
EQ 400MG BASE
EQ 400MG BASE
EQ 200MG BASE
EQ 200MG BASE
EQ 200MG BASE
ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL
GRANULE;ORAL
ERYZOLE
ALRA
PEDIAZOLE
ROSS LABS
ERYTHROMYCIN GLUCEPTATE
INJECTABLE;INJECTION
ILOTYCIN GLUCEPTATE
DISTA
ERYTHROMYCIN LACTOBIONATE
INJECTABLE;INJECTION
ERYTHROCIN
ABBOTT
HOSPIRA
ERYTHROMYCIN
ELKINS SINN
ERYTHROMYCIN LACTOBIONATE
ABRAXIS PHARM
BAXTER HLTHCARE
TEVA PARENTERAL
ERYTHROMYCIN STEARATE
TABLET;ORAL
BRISTAMYCIN
BRISTOL
ERYPAR
PARKE DAVIS
WARNER CHILCOTT
ERYTHROCIN STEARATE
ARBOR PHARMS INC
ERYTHROMYCIN STEARATE
BARR
EQ 200MG BASE/5ML;EQ 600MG BASE/5ML
EQ 200MG BASE/5ML;EQ 600MG BASE/5ML
EQ 1GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 250MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 125MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
6-121( of 322)
A062231 002
A062559 001 Mar 15, 1985
A062558 001 Mar 15, 1985
A062123 002
A062123 001
A062305 002
A061905 001
A062256 001
A062847 001 Sep 14, 1988
N050297 002
N050297 003 Jul 05, 1988
A062306 001
A062758 001 Jun 15, 1988
N050529 001
N050370 003
N050370 001
N050370 002
A062586 002 Jan 04, 1988
A062586 001 Jan 04, 1988
N050182 003
N050609 002 Sep 24, 1986
N050182 002
A062563 002 Mar 28, 1985
A062563 001 Mar 28, 1985
A062604 002 Nov 24, 1986
A062604 001 Nov 24, 1986
A062993 002 May 09, 1989
A062993 001 May 09, 1989
A063253 002 Jul 30, 1993
A063253 001 Jul 30, 1993
A061304 001
A061887 001
A062032 001
A062032 002
A062322 001
A060359 002
A060359 003
A061591 001
A063179 001 May 15, 1990
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-122( of 322)
ERYTHROMYCIN STEARATE
TABLET;ORAL
ERYTHROMYCIN STEARATE
IVAX SUB TEVA PHARMS EQ 250MG BASE A061461 001
EQ 500MG BASE A061461 002
LEDERLE EQ 250MG BASE A062089 001
EQ 500MG BASE A062089 002
MYLAN EQ 250MG BASE A061505 001
EQ 500MG BASE A061505 002
PUREPAC PHARM EQ 250MG BASE A061743 001
WATSON LABS EQ 250MG BASE A062121 002
EQ 500MG BASE A062121 001
ETHRIL 250
BRISTOL MYERS SQUIBB EQ 250MG BASE A061605 001
ETHRIL 500
BRISTOL MYERS SQUIBB EQ 500MG BASE A061605 002
PFIZER-E
PFIZER EQ 250MG BASE A061791 001
EQ 500MG BASE A061791 002
WYAMYCIN S
WYETH AYERST EQ 250MG BASE A061675 001
EQ 500MG BASE A061675 002
ESCITALOPRAM OXALATE
CAPSULE;ORAL
ESCITALOPRAM OXALATE
MYLAN PHARMS INC EQ 5MG BASE A077660 001 Jul 31, 2007
EQ 10MG BASE A077660 002 Jul 31, 2007
EQ 20MG BASE A077660 003 Jul 31, 2007
ESMOLOL HYDROCHLORIDE
INJECTABLE;INJECTION
BREVIBLOC
BAXTER HLTHCARE 10MG/ML N019386 003 Aug 15, 1988
20MG/ML N019386 007 May 28, 2003
ESTAZOLAM
TABLET;ORAL
PROSOM
ABBOTT 1MG N019080 001 Dec 26, 1990
2MG N019080 002 Dec 26, 1990
ESTRADIOL
FILM, EXTENDED RELEASE;TRANSDERMAL
ESCLIM
WOMEN FIRST HLTHCARE 0.025MG/24HR N020847 001 Aug 04, 1998
0.0375MG/24HR N020847 002 Aug 04, 1998
0.05MG/24HR N020847 003 Aug 04, 1998
0.075MG/24HR N020847 004 Aug 04, 1998
0.1MG/24HR N020847 005 Aug 04, 1998
ESTRADIOL
ORTHO MCNEIL PHARM 0.05MG/24HR N021048 001 Sep 20, 1999
0.075MG/24HR N021048 002 Sep 20, 1999
0.1MG/24HR N021048 003 Sep 20, 1999
FEMPATCH
PARKE DAVIS 0.025MG/24HR N020417 001 Dec 03, 1996
VIVELLE
NOVARTIS 0.025MG/24HR N020323 005 Aug 16, 2000
0.0375MG/24HR N020323 001 Oct 28, 1994
0.075MG/24HR N020323 003 Oct 28, 1994
GEL;TOPICAL
ESTROGEL
ASCEND 0.06% N021166 001 Feb 09, 2004
TABLET;ORAL
ESTRACE
BRISTOL MYERS SQUIBB 0.5MG **Federal Register determination A081295 001 Jun 30, 1993
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
1MG **Federal Register determination A084499 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
2MG **Federal Register determination A084500 001
that product was not discontinued or
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ESTRADIOL
TABLET;ORAL
ESTRACE
ESTRADIOL
AAI PHARMA INC
HERITAGE PHARMS INC
GYNODIOL
DURAMED PHARMS BARR
INNOFEM
NOVO NORDISK INC
TABLET;VAGINAL
VAGIFEM
NOVO NORDISK INC
ESTRADIOL CYPIONATE
INJECTABLE;INJECTION
DEPO-ESTRADIOL
PHARMACIA AND UPJOHN
withdrawn for safety or efficacy
reasons**
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
1.5MG
2MG
0.5MG
1MG
2MG
25MCG
1MG/ML
3MG/ML
ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE
INJECTABLE;INTRAMUSCULAR
LUNELLE
PHARMACIA AND UPJOHN 5MG/0.5ML;25MG/0.5ML
ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE
INJECTABLE;INJECTION
DEPO-TESTADIOL
PHARMACIA AND UPJOHN 2MG/ML;50MG/ML
TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE
WATSON LABS 2MG/ML;50MG/ML
ESTRADIOL VALERATE
INJECTABLE;INJECTION
ESTRADIOL VALERATE
WATSON LABS 10MG/ML
40MG/ML
WATSON LABS INC 20MG/ML
ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE
INJECTABLE;INJECTION
DITATE-DS
SAVAGE LABS 8MG/ML;180MG/ML
TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE
WATSON LABS
ESTROGENS, CONJUGATED
TABLET;ORAL
PREMARIN
WYETH PHARMS INC
4MG/ML;90MG/ML
8MG/ML;180MG/ML
2.5MG
ESTROGENS, CONJUGATED SYNTHETIC A
CREAM;VAGINAL
SYNTHETIC CONJUGATED ESTROGENS A
TEVA WOMENS 0.625MG/GM
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
TABLET;ORAL-28
PREMPHASE (PREMARIN;CYCRIN 14/14)
WYETH PHARMS INC 0.625MG;0.625MG;N/A,5MG
PREMPRO (PREMARIN;CYCRIN)
WYETH PHARMS INC 0.625MG;0.625MG;2.5MG;2.5MG
6-123( of 322)
A040138 001 Jan 30, 1998
A040138 002 Jan 30, 1998
A040138 003 Jan 30, 1998
A040275 001 Dec 29, 1998
A040275 002 Dec 29, 1998
A040275 003 Dec 29, 1998
A040212 001 Dec 29, 1997
A040212 002 Dec 29, 1997
A040212 003 Dec 29, 1997
A040212 004 Dec 29, 1997
A040312 001 Nov 19, 1999
A040312 002 Nov 19, 1999
A040312 003 Nov 19, 1999
N020908 001 Mar 26, 1999
A085470 001
A085470 002
N020874 001 Oct 05, 2000
N017968 001
A085603 001 Mar 13, 1986
A083546 001
A083714 001
A083547 001
A086423 001
A085865 001
A085860 001
N004782 002
N021788 001 Nov 28, 2008
N020303 002 Dec 30, 1994
N020303 001 Dec 30, 1994
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ESTROGENS, CONJUGATED; MEPROBAMATE
TABLET;ORAL
MILPREM-200
MEDPOINTE PHARM HLC
MILPREM-400
MEDPOINTE PHARM HLC
PMB 200
WYETH AYERST
PMB 400
WYETH AYERST
ESTROGENS, ESTERIFIED
TABLET;ORAL
AMNESTROGEN
BRISTOL MYERS SQUIBB
ESTERIFIED ESTROGENS
PVT FORM
SANDOZ
ESTRATAB
SOLVAY
EVEX
ROCHE PALO
FEMOGEN
PVT FORM
ESTRONE
INJECTABLE;INJECTION
ESTROGENIC SUBSTANCE
WYETH AYERST
ESTRONE
WATSON LABS
NATURAL ESTROGENIC SUBSTANCE-ESTRONE
0.45MG;200MG
0.45MG;400MG
0.45MG;200MG
0.45MG;400MG
0.3MG
0.625MG
1.25MG
2.5MG
0.625MG
1.25MG
2.5MG
1.25MG
0.3MG
0.625MG
1.25MG
2.5MG
0.625MG
1.25MG
0.625MG
1.25MG
2.5MG
2MG/ML
2MG/ML
5MG/ML
WATSON LABS
THEELIN
PARKEDALE
ESTROPIPATE
CREAM;VAGINAL
OGEN
PHARMACIA AND UPJOHN
TABLET;ORAL
ESTROPIPATE
DURAMED PHARMS BARR
MYLAN
ORTHO-EST
CARACO
ESZOPICLONE
TABLET;ORAL
ESZOPICLONE
LUPIN LTD
TEVA
WOCKHARDT LTD
2MG/ML
1MG/ML
2MG/ML
5MG/ML
1.5MG/GM
0.75MG
1.5MG
3MG
3MG
0.75MG
1.5MG
1MG
2MG
3MG
1MG
2MG
3MG
1MG
6-124( of 322)
N011045 002
N011045 001
N010971 005
N010971 003
A083266 001
A083266 002
A083266 003
A083266 004
A083414 001
A083765 001
A085907 001
A085302 001
A086715 001
A083209 001
A083856 001
A083857 001
A084215 001
A083376 002
A085076 001
A085008 001
A085007 001
A083488 001
A083397 001
A085239 001
A085237 001 Nov 23, 1982
N003977 001
N003977 002
N003977 003
A084710 001
A040296 001 Nov 01, 1999
A040296 002 Nov 01, 1999
A040296 003 Nov 01, 1999
A040359 003 Aug 26, 1999
A089567 001 Feb 27, 1991
A089582 001 Jul 17, 1991
A091124 001 Sep 13, 2011
A091124 002 Sep 13, 2011
A091124 003 Sep 13, 2011
A091169 001 May 23, 2011
A091169 002 May 23, 2011
A091169 003 May 23, 2011
A091165 001 Jul 14, 2011
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-125( of 322)
ESZOPICLONE
TABLET;ORAL
ESZOPICLONE
2MG A091165 002 Jul 14, 2011
3MG A091165 003 Jul 14, 2011
ETHACRYNIC ACID
TABLET;ORAL
EDECRIN
ATON 50MG N016092 002
ETHAMBUTOL HYDROCHLORIDE
TABLET;ORAL
ETHAMBUTOL HYDROCHLORIDE
WEST WARD 100MG A075095 001 Nov 30, 1999
400MG A075095 002 Nov 30, 1999
MYAMBUTOL
STI PHARMA LLC 200MG N016320 002
500MG N016320 004
ETHCHLORVYNOL
CAPSULE;ORAL
ETHCHLORVYNOL
BANNER PHARMACAPS 100MG A084463 001
200MG A084463 002
500MG A084463 003
750MG A084463 004
PLACIDYL
ABBVIE 100MG N010021 004
200MG N010021 007
500MG N010021 002
750MG N010021 010
ETHINAMATE
CAPSULE;ORAL
VALMID
DISTA 500MG N009750 001
ETHINYL ESTRADIOL
TABLET;ORAL
ESTINYL
SCHERING 0.02MG N005292 001
0.05MG N005292 002
0.5MG N005292 003
FEMINONE
PHARMACIA AND UPJOHN 0.05MG N016649 001
LYNORAL
ORGANON USA INC 0.01MG N005490 003
0.05MG N005490 002
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
TABLET;ORAL-21
DEMULEN 1/35-21
GD SEARLE LLC 0.035MG;1MG **Federal Register N018168 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
DEMULEN 1/50-21
GD SEARLE LLC 0.05MG;1MG N016927 001
ZOVIA 1/35E-21
WATSON LABS 0.035MG;1MG A072720 001 Dec 30, 1991
ZOVIA 1/50E-21
WATSON LABS 0.05MG;1MG A072722 001 Dec 30, 1991
TABLET;ORAL-28
DEMULEN 1/35-28
GD SEARLE LLC 0.035MG;1MG N018160 001
DEMULEN 1/50-28
GD SEARLE LLC 0.05MG;1MG N016936 001
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE
TABLET;ORAL-28
NORQUEST FE
GD SEARLE LLC 0.035MG;75MG;1MG N018926 001 Jul 18, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-126( of 322)
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE ACETATE
TABLET;ORAL-28
NORLESTRIN FE 1/50
PARKE DAVIS 0.05MG;75MG;1MG N016766 001
NORLESTRIN FE 2.5/50
PARKE DAVIS 0.05MG;75MG;2.5MG N016854 001
ETHINYL ESTRADIOL; LEVONORGESTREL
TABLET;ORAL
LYBREL
WYETH PHARMS INC 0.02MG;0.09MG N021864 001 May 22, 2007
PREVEN EMERGENCY CONTRACEPTIVE KIT
TEVA BRANDED PHARM 0.05MG;0.25MG N020946 001 Sep 01, 1998
TABLET;ORAL-21
ALESSE
WYETH PHARMS 0.02MG;0.1MG **Federal Register N020683 001 Mar 27, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
AVIANE-21
DURAMED PHARMS BARR 0.02MG;0.1MG A075796 002 Apr 30, 2001
ENPRESSE-21
DURAMED PHARMS BARR 0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1 A075809 001 Jul 16, 2001
25MG
LESSINA-21
BARR 0.02MG;0.1MG A075803 001 Mar 20, 2002
LEVLITE
BAYER HLTHCARE 0.02MG;0.1MG N020860 001 Jul 13, 1998
LEVONORGESTREL AND ETHINYL ESTRADIOL
BARR 0.02MG;0.1MG A075862 001 Apr 29, 2003
LEVORA 0.15/30-21
WATSON LABS 0.03MG;0.15MG A073592 001 Dec 13, 1993
NORDETTE-21
TEVA BRANDED PHARM 0.03MG;0.15MG N018668 001 May 10, 1982
PORTIA-21
BARR 0.03MG;0.15MG A075866 001 May 23, 2002
TRIPHASIL-21
WYETH PHARMS 0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1 N019192 001 Nov 01, 1984
25MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
TRIVORA-21
WATSON LABS 0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1 A074538 001 Dec 18, 1997
25MG
TABLET;ORAL-28
ALESSE
WYETH PHARMS 0.02MG;0.1MG N020683 002 Mar 27, 1997
LEVLITE
BAYER HLTHCARE 0.02MG;0.1MG N020860 002 Jul 13, 1998
LEVONORGESTREL AND ETHINYL ESTRADIOL
BARR 0.02MG;0.1MG A075862 002 Apr 29, 2003
TRIPHASIL-28
WYETH PHARMS INC 0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1 N019190 001 Nov 01, 1984
25MG
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET;ORAL-21
BALZIVA-21
BARR 0.035MG;0.4MG A076198 001 Apr 22, 2004
BREVICON 21-DAY
WATSON LABS 0.035MG;0.5MG N017566 001
GENCEPT 10/11-21
BARR 0.035MG;0.035MG;0.5MG;1MG A072694 001 Feb 28, 1992
MODICON 21
ORTHO MCNEIL PHARM 0.035MG;0.5MG N017488 001
N.E.E. 1/35 21
LPI 0.035MG;1MG A071541 001 Dec 14, 1987
NORCEPT-E 1/35 21
ORTHO MCNEIL PHARM 0.035MG;1MG A071545 001 Feb 09, 1989
NORETHINDRONE AND ETHINYL ESTRADIOL
WATSON LABS 0.035MG;0.5MG A070684 001 Jan 29, 1987
NORTREL 0.5/35-21
BARR 0.035MG;0.5MG A072692 001 Feb 28, 1992
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET;ORAL-21
ORTHO-NOVUM 1/35-21
ORTHO MCNEIL PHARM
ORTHO-NOVUM 10/11-21
ORTHO MCNEIL JANSSEN
ORTHO-NOVUM 7/14-21
ORTHO MCNEIL PHARM
ORTHO-NOVUM 7/7/7-21
JANSSEN PHARMS
OVCON-35
WARNER CHILCOTT
OVCON-50
WARNER CHILCOTT
TRI-NORINYL 21-DAY
WATSON LABS
TABLET;ORAL-28
GENCEPT 10/11-28
BARR
N.E.E. 1/35 28
LPI
NORCEPT-E 1/35 28
ORTHO MCNEIL PHARM
ORTHO-NOVUM 10/11-28
ORTHO MCNEIL JANSSEN
ORTHO-NOVUM 7/14-28
ORTHO MCNEIL PHARM
OVCON-50
WARNER CHILCOTT LLC
0.035MG;1MG
0.035MG;0.035MG;0.5MG;1MG
0.035MG;0.035MG;0.5MG;1MG
0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M
G
0.035MG;0.4MG
0.05MG;1MG
0.035MG;0.035MG;0.035MG;0.5MG;0.5MG;1MG
0.035MG;0.035MG;0.5MG;1MG
0.035MG;1MG
0.035MG;1MG
0.035MG;0.035MG;0.5MG;1MG
0.035MG;0.035MG;0.5MG;1MG
0.05MG;1MG
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
CAPSULE;ORAL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
WARNER CHILCOTT
TABLET;ORAL
FEMHRT
WARNER CHILCOTT LLC
TABLET;ORAL-21
ESTROSTEP 21
WARNER CHILCOTT LLC
NORLESTRIN 21 1/50
PARKE DAVIS
NORLESTRIN 21 2.5/50
PARKE DAVIS
TABLET;ORAL-28
NORLESTRIN 28 1/50
PARKE DAVIS
ETHINYL ESTRADIOL; NORGESTIMATE
TABLET;ORAL-21
ORTHO CYCLEN-21
JANSSEN PHARMS
ORTHO TRI-CYCLEN
JANSSEN PHARMS
TABLET;ORAL-28
TRI LO SPRINTEC
BARR LABS INC
ETHINYL ESTRADIOL; NORGESTREL
TABLET;ORAL-21
LO/OVRAL
WYETH PHARMS INC
OGESTREL 0.5/50-21
WATSON LABS
OVRAL
WYETH PHARMS
0.02MG;1MG
0.005MG;1MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
0.02MG;0.035MG;0.03MG;1MG;1MG;1MG
0.05MG;1MG
0.05MG;2.5MG
0.05MG;1MG
0.035MG;0.25MG
0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;
0.25MG
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,
0.25MG
0.03MG;0.3MG
0.05MG;0.5MG
0.05MG;0.5MG
N017489 002
N018354 001
N019004 001
N018985 001
N018127 001
N018128 001
N018977 001
A072697 001
A071542 001
A071546 001
N018354 002
N019004 002
N017576 001
N204426 001
N021065 002
N020130 001
N016749 001
N016852 001
N016723 001
N019653 001
N019697 002
A076784 001
N017612 001
A075406 001
N016672 001
6-127( of 322)
Jan 11, 1982
Apr 04, 1984
Apr 04, 1984
Apr 13, 1984
Feb 28, 1992
Dec 14, 1987
Feb 09, 1989
Jan 11, 1982
Apr 04, 1984
Apr 19, 2013
Oct 15, 1999
Oct 09, 1996
Dec 29, 1989
Jul 03, 1992
Jun 29, 2009
Dec 15, 1999
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ETHINYL ESTRADIOL; NORGESTREL
TABLET;ORAL-28
OVRAL-28
WYETH PHARMS 0.05MG;0.5MG
ETHIODIZED OIL
OIL;INTRALYMPHATIC, INTRAUTERINE
ETHIODOL
GUERBET
ETHOPROPAZINE HYDROCHLORIDE
TABLET;ORAL
PARSIDOL
PARKE DAVIS
ETHOTOIN
TABLET;ORAL
PEGANONE
RECORDATI RARE
ETHOXZOLAMIDE
TABLET;ORAL
CARDRASE
PHARMACIA AND UPJOHN
ETHAMIDE
ALLERGAN
ETHYLESTRENOL
ELIXIR;ORAL
MAXIBOLIN
ORGANON USA INC
TABLET;ORAL
MAXIBOLIN
ORGANON USA INC
ETHYNODIOL DIACETATE; MESTRANOL
TABLET;ORAL-20
OVULEN
GD SEARLE LLC
TABLET;ORAL-21
OVULEN-21
GD SEARLE LLC
TABLET;ORAL-28
OVULEN-28
GD SEARLE LLC
ETIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
DURANEST
ASTRAZENECA
ETIDRONATE DISODIUM
INJECTABLE;INJECTION
DIDRONEL
MGI PHARMA INC
ETODOLAC
CAPSULE;ORAL
ETODOLAC
AAIPHARMA LLC
IVAX SUB TEVA PHARMS
MYLAN
SANDOZ
TEVA
VINTAGE PHARMS LLC
99%
10MG
50MG
100MG
500MG
62.5MG
125MG
125MG
2MG/5ML
2MG
1MG;0.1MG
1MG;0.1MG
1MG;0.1MG
0.5%
1%
50MG/ML
300MG
200MG
300MG
200MG
200MG
300MG
300MG
200MG
200MG
300MG
300MG
200MG
200MG
300MG
6-128( of 322)
N016806 001
N009190 001
N009078 003
N009078 006
N009078 008
N010841 003
N011047 002
N011047 001
N016144 001
N014006 002
N014005 002
N016029 002
N016029 003
N016705 001
N017751 003
N017751 005
N019545 001 Apr 20, 1987
A074929 001 Jan 30, 1998
A074899 001 Jul 08, 1997
A074899 002 Jul 08, 1997
A074932 001 May 16, 1997
A075071 001 Sep 30, 1998
A074932 002 May 16, 1997
A075071 002 Sep 30, 1998
A074840 001 Aug 29, 1997
A074942 001 Sep 30, 1997
A074840 002 Aug 29, 1997
A074942 002 Sep 30, 1997
A075126 001 Sep 16, 1999
A074842 001 Jul 17, 1997
A074842 002 Jul 17, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-129( of 322)
ETODOLAC
CAPSULE;ORAL
ETODOLAC
WATSON LABS 200MG A074844 001 Dec 23, 1997
300MG A074844 002 Dec 23, 1997
LODINE
WYETH PHARMS INC 200MG N018922 002 Jan 31, 1991
300MG N018922 003 Jan 31, 1991
TABLET;ORAL
ETODOLAC
AAIPHARMA LLC 400MG A074927 001 Oct 30, 1997
IVAX SUB TEVA PHARMS 400MG A074883 001 Feb 28, 1997
500MG A074883 002 Nov 20, 1998
MYLAN 400MG A075012 001 Sep 30, 1998
500MG A075012 002 Sep 30, 1998
PROSAM LABS 400MG A074819 001 Feb 28, 1997
500MG A074819 002 Apr 28, 1998
RANBAXY LABS LTD 400MG A075226 001 Nov 24, 1998
500MG A075226 002 Nov 24, 1998
SANDOZ 400MG A074839 001 Jul 11, 1997
400MG A074846 001 Feb 28, 1997
TEVA 400MG A074847 001 Apr 23, 1999
500MG A074847 002 Apr 23, 1999
VINTAGE PHARMS LLC 400MG A074841 001 Jun 27, 1997
WATSON LABS 400MG A074892 001 Apr 16, 1997
400MG A075069 001 Apr 16, 1998
500MG A074892 002 Oct 29, 1998
LODINE
WYETH PHARMS INC 400MG N018922 004 Jul 29, 1993
500MG N018922 005 Jun 28, 1996
TABLET, EXTENDED RELEASE;ORAL
ETODOLAC
ACTAVIS ELIZABETH 400MG A075696 001 Jul 31, 2000
SANDOZ 400MG A075943 001 Jul 26, 2002
500MG A075943 002 Jul 26, 2002
600MG A075943 003 Jul 26, 2002
WATSON LABS FLORIDA 400MG A075829 001 Nov 30, 2001
500MG A075829 002 Nov 30, 2001
LODINE XL
WYETH PHARMS INC 400MG N020584 001 Oct 25, 1996
500MG N020584 003 Jan 20, 1998
600MG N020584 002 Oct 25, 1996
ETOPOSIDE
CAPSULE;ORAL
VEPESID
CORDEN PHARMA 50MG N019557 001 Dec 30, 1986
100MG N019557 002 Dec 30, 1986
INJECTABLE;INJECTION
ETOPOSIDE
HOSPIRA 20MG/ML A074320 001 Aug 30, 1995
20MG/ML A074351 001 Aug 30, 1995
MARSAM PHARMS LLC 20MG/ML A074968 001 Jan 09, 1998
PHARMACHEMIE 20MG/ML A074227 001 Feb 22, 1996
PIERRE FABRE 20MG/ML A074813 001 Jul 09, 1997
TEVA PARENTERAL 20MG/ML A074510 001 Jun 29, 1995
WATSON LABS 20MG/ML A074228 001 Oct 15, 1996
TOPOSAR
TEVA PARENTERAL 20MG/ML A074166 001 Feb 27, 1995
VEPESID
CORDEN PHARMA 20MG/ML N018768 001 Nov 10, 1983
ETOPOSIDE PHOSPHATE
INJECTABLE;INJECTION
ETOPOPHOS PRESERVATIVE FREE
BRISTOL MYERS SQUIBB EQ 1GM BASE/VIAL N020906 002 Feb 27, 1998
EQ 500MG BASE/VIAL N020906 001 Feb 27, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-130( of 322)
ETRETINATE
CAPSULE;ORAL
TEGISON
ROCHE 10MG N019369 001 Sep 30, 1986
25MG N019369 002 Sep 30, 1986
EVANS BLUE
INJECTABLE;INJECTION
EVANS BLUE
PARKE DAVIS 0.5% **Federal Register determination N008041 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
FAMOTIDINE
INJECTABLE;INJECTION
FAMOTIDINE
APOTEX INC 10MG/ML A075942 001 Aug 02, 2002
APOTHECON 10MG/ML A075707 001 Apr 16, 2001
HIKMA MAPLE 10MG/ML A075799 001 Apr 30, 2002
HOSPIRA 10MG/ML A075705 001 Apr 16, 2001
10MG/ML A075870 001 Nov 23, 2001
10MG/ML A075905 001 Nov 23, 2001
FAMOTIDINE PRESERVATIVE FREE
APOTEX INC 10MG/ML A076324 001 Nov 27, 2002
APOTHECON 10MG/ML A075708 001 Apr 16, 2001
HIKMA MAPLE 10MG/ML A075789 001 Apr 30, 2002
HOSPIRA 10MG/ML A075669 001 Apr 16, 2001
FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)
APOTEX INC 10MG/ML A076322 001 Nov 27, 2002
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
ABBVIE 0.4MG/ML A075729 001 Dec 17, 2001
PEPCID
MERCK 10MG/ML **Federal Register N019510 001 Nov 04, 1986
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
PEPCID PRESERVATIVE FREE
MERCK 10MG/ML **Federal Register N019510 004 Nov 04, 1986
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER
MERCK SHARP DOHME 0.4MG/ML **Federal Register N020249 001 Feb 18, 1994
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
FAMOTIDINE
ACTAVIS ELIZABETH 20MG A075650 001 Sep 14, 2001
40MG A075650 002 Sep 14, 2001
APOTEX 10MG A075610 001 Mar 12, 2002
MUTUAL PHARM 20MG A075639 002 Dec 12, 2001
40MG A075639 001 Dec 12, 2001
MYLAN PHARMS INC 20MG A075457 001 Apr 18, 2001
40MG A075457 002 Apr 18, 2001
SANDOZ 10MG A076101 001 Oct 21, 2002
20MG A075302 001 Apr 16, 2001
20MG A075607 001 May 10, 2001
20MG A075793 001 Apr 16, 2001
40MG A075302 002 Apr 16, 2001
40MG A075607 002 May 10, 2001
40MG A075793 002 Apr 16, 2001
WATSON LABS 20MG A075062 002 Apr 16, 2001
40MG A075062 001 Apr 16, 2001
TABLET, CHEWABLE;ORAL
PEPCID AC
MCNEIL CONS 10MG N020801 001 Sep 24, 1998
TABLET, ORALLY DISINTEGRATING;ORAL
FLUXID
UCB INC 20MG N021712 001 Sep 24, 2004
40MG N021712 002 Sep 24, 2004
PEPCID RPD
MERCK 20MG N020752 001 May 28, 1998
40MG N020752 002 May 28, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
FENOFIBRATE
CAPSULE;ORAL
ANTARA (MICRONIZED)
LUPIN ATLANTIS 87MG
LIPIDIL
ABBVIE 100MG
LIPOFEN
CIPHER PHARMS INC 100MG
TRICOR (MICRONIZED)
ABBVIE 67MG
134MG
200MG
TABLET;ORAL
FENOFIBRATE
MYLAN 107MG
TRICOR
ABBOTT 54MG
160MG
FENOLDOPAM MESYLATE
INJECTABLE;INJECTION
FENOLDOPAM MESYLATE
LUITPOLD EQ 10MG BASE/ML
TEVA PARENTERAL EQ 10MG BASE/ML
FENOPROFEN CALCIUM
CAPSULE;ORAL
FENOPROFEN CALCIUM
AM THERAP EQ 200MG BASE
EQ 300MG BASE
HALSEY EQ 200MG BASE
EQ 300MG BASE
PAR PHARM EQ 200MG BASE
EQ 300MG BASE
QUANTUM PHARMICS EQ 200MG BASE
EQ 300MG BASE
SANDOZ EQ 200MG BASE
EQ 300MG BASE
WARNER CHILCOTT EQ 200MG BASE
EQ 300MG BASE
WATSON LABS EQ 200MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 300MG BASE
NALFON
XSPIRE EQ 300MG BASE
TABLET;ORAL
FENOPROFEN CALCIUM
ACTAVIS ELIZABETH EQ 600MG BASE
AM THERAP EQ 600MG BASE
CLONMEL HLTHCARE EQ 600MG BASE
HALSEY EQ 600MG BASE
IVAX SUB TEVA PHARMS EQ 600MG BASE
MUTUAL PHARM EQ 600MG BASE
PAR PHARM EQ 600MG BASE
QUANTUM PHARMICS EQ 600MG BASE
SANDOZ EQ 600MG BASE
USL PHARMA EQ 600MG BASE
WATSON LABS EQ 600MG BASE
EQ 600MG BASE
EQ 600MG BASE
NALFON
DISTA EQ 600MG BASE
FENTANYL CITRATE
FILM;BUCCAL
ONSOLIS
MEDA PHARMS EQ 0.2MG BASE
EQ 0.4MG BASE
EQ 0.6MG BASE
EQ 0.8MG BASE
EQ 1.2MG BASE
6-131( of 322)
N021695 002 Nov 30, 2004
N019304 001 Dec 31, 1993
N021612 002 Jan 11, 2006
N019304 002 Feb 09, 1998
N019304 003 Jun 30, 1999
N019304 004 Jun 30, 1999
A076520 002 Dec 29, 2005
N021203 001 Sep 04, 2001
N021203 003 Sep 04, 2001
A076656 001 Dec 01, 2003
A077826 001 Mar 07, 2007
A072307 001 Aug 22, 1988
A072308 001 Aug 22, 1988
A072355 001 Aug 17, 1988
A072356 001 Aug 17, 1988
A072437 001 Aug 22, 1988
A072438 001 Aug 22, 1988
A072214 001 Aug 17, 1988
A071738 001 Aug 17, 1988
A072394 001 Oct 17, 1988
A072395 001 Oct 17, 1988
A072946 001 Apr 30, 1991
A072472 001 Apr 30, 1991
A072294 001 Aug 17, 1988
A072981 001 Aug 19, 1991
A072293 001 Aug 17, 1988
A072982 001 Aug 19, 1991
N017604 002
A072274 001 May 02, 1988
A072309 001 Aug 17, 1988
A072326 001 Aug 17, 1988
A072357 001 Aug 17, 1988
A072557 001 Aug 29, 1988
A072902 001 Dec 21, 1990
A072429 001 Aug 17, 1988
A072194 001 Aug 17, 1988
A072396 001 Oct 17, 1988
A072362 001 Aug 17, 1988
A072165 001 Aug 17, 1988
A072407 001 Aug 17, 1988
A072602 001 Oct 11, 1988
N017710 001
N022266 001 Jul 16, 2009
N022266 002 Jul 16, 2009
N022266 003 Jul 16, 2009
N022266 004 Jul 16, 2009
N022266 005 Jul 16, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
FENTANYL CITRATE
INJECTABLE;INJECTION
FENTANYL CITRATE
ABBOTT EQ 0.05MG BASE/ML
EQ 0.05MG BASE/ML
WATSON LABS EQ 0.05MG BASE/ML
FENTANYL CITRATE PRESERVATIVE FREE
MARSAM PHARMS LLC
TABLET;BUCCAL, SUBLINGUAL
FENTORA
CEPHALON
TROCHE/LOZENGE;ORAL
FENTANYL
CEPHALON
FENTANYL HYDROCHLORIDE
EQ 0.05MG BASE/ML
EQ 0.3MG BASE
EQ 0.1MG BASE
EQ 0.2MG BASE
EQ 0.3MG BASE
EQ 0.4MG BASE
SYSTEM;IONTOPHORESIS, TRANSDERMAL
IONSYS
INCLINE THERAP
FERRIC AMMONIUM CITRATE
FOR SOLUTION;ORAL
FERRISELTZ
OTSUKA
FERROUS CITRATE, FE-59
INJECTABLE;INJECTION
FERROUS CITRATE FE 59
MALLINCKRODT
FERROUS SULFATE; FOLIC ACID
CAPSULE;ORAL
FOLVRON
LEDERLE
FERUMOXIDES
INJECTABLE;INJECTION
FERIDEX I.V.
AMAG PHARMS INC
FERUMOXSIL
SUSPENSION;ORAL
GASTROMARK
AMAG PHARMS INC
FEXOFENADINE HYDROCHLORIDE
CAPSULE;ORAL
ALLEGRA
SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE
BARR
FIBRINOGEN, I-125
INJECTABLE;INJECTION
IBRIN
GE HEALTHCARE
RADIONUCLIDE-LABELED (125 I) FIBRINOGEN (HUMAN) SENSOR
ABBOTT
FINASTERIDE
TABLET;ORAL
FINASTERIDE
IVAX SUB TEVA PHARMS
FLAVOXATE HYDROCHLORIDE
TABLET;ORAL
URISPAS
ORTHO MCNEIL JANSSEN
10.8MCG
600MG/PACKET
25uCi/ML
182MG;0.33MG
EQ 11.2MG IRON/ML
EQ 0.175MG IRON/ML
60MG
60MG
154uCi/VIAL
140uCi/ML
5MG
100MG
6-132( of 322)
A070636 001 Apr 30, 1990
A070637 001 Apr 30, 1990
A073488 001 Jun 30, 1992
A074917 001 Feb 03, 1998
N021947 006 Mar 02, 2007
N020195 007 Oct 30, 1995
N020195 001 Oct 04, 1993
N020195 002 Oct 04, 1993
N020195 003 Oct 04, 1993
N021338 001 May 22, 2006
N020292 001 Oct 14, 1997
N016729 001
N006012 003
N020416 001 Aug 30, 1996
N020410 001 Dec 06, 1996
N020625 001 Jul 25, 1996
A076169 001 Jul 13, 2005
N017879 001
N017787 001
A076340 001 Jun 19, 2006
N016769 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
FLECAINIDE ACETATE
TABLET;ORAL
FLECAINIDE ACETATE
APOTEX INC 50MG
100MG
150MG
SANDOZ 50MG
100MG
150MG
TAMBOCOR
MEDICIS 50MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
100MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
150MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
200MG
FLOXURIDINE
INJECTABLE;INJECTION
FUDR
HOSPIRA 500MG/VIAL
FLUCONAZOLE
FOR SUSPENSION;ORAL
FLUCONAZOLE
TARO PHARM INDS 50MG/5ML
200MG/5ML
INJECTABLE;INJECTION
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
AGILA SPECLTS 200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AGILA SPECLTS 200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
HOSPIRA 200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
TABLET;ORAL
FLUCONAZOLE
GEDEON RICHTER USA 50MG
100MG
150MG
200MG
HARRIS PHARM 50MG
100MG
150MG
200MG
MYLAN PHARMS INC 50MG
100MG
150MG
200MG
PLIVA 50MG
100MG
150MG
200MG
RANBAXY LABS LTD 50MG
100MG
150MG
200MG
ROXANE 50MG
100MG
150MG
200MG
SANDOZ 50MG
100MG
150MG
200MG
A079164 001
A079164 002
A079164 003
A076030 001
A076030 002
A076030 003
N018830 004
N018830 001
N018830 003
N018830 002
N016929 001
A076918 001
A076918 002
A076888 001
A076888 002
A076889 001
A076889 002
A076617 001
A076617 002
A076432 001
A076432 002
A076432 003
A076432 004
A078423 001
A078423 002
A078423 003
A078423 004
A076042 001
A076042 002
A076042 003
A076042 004
A076424 001
A076424 002
A076424 003
A076424 004
A076386 001
A076386 002
A076386 003
A076386 004
A076213 001
A076213 002
A076213 003
A076213 004
A076086 001
A076086 002
A076086 003
A076086 004
6-133( of 322)
Jul 09, 2009
Jul 09, 2009
Jul 09, 2009
Oct 28, 2002
Oct 28, 2002
Oct 28, 2002
Aug 23, 1988
Oct 31, 1985
Jun 03, 1988
Oct 31, 1985
Dec 18, 2006
Dec 18, 2006
Mar 25, 2005
Mar 25, 2005
Mar 25, 2005
Mar 25, 2005
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Mar 07, 2011
Mar 07, 2011
Mar 07, 2011
Mar 07, 2011
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
Jul 29, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-134( of 322)
FLUDARABINE PHOSPHATE
INJECTABLE;INJECTION
FLUDARA
GENZYME CORP 50MG/VIAL N020038 001 Apr 18, 1991
TABLET;ORAL
OFORTA
SANOFI AVENTIS US 10MG N022273 001 Dec 18, 2008
FLUDEOXYGLUCOSE F-18
INJECTABLE;INJECTION
FLUDEOXYGLUCOSE F 18
DOWNSTATE CLINCL 4-40mCi/ML **Federal Register N020306 001 Aug 19, 1994
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
4-90mCi/ML **Federal Register N020306 002 Sep 25, 2001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
FLUDROCORTISONE ACETATE
TABLET;ORAL
FLORINEF
CITRON PHARMA LLC 0.1MG N010060 001
FLUMAZENIL
INJECTABLE;INJECTION
FLUMAZENIL
APOTEX INC 0.5MG/5ML (0.1MG/ML) A076755 002 Oct 12, 2004
1MG/10ML (0.1MG/ML) A076755 001 Oct 12, 2004
TEVA PHARMS USA 0.5MG/5ML (0.1MG/ML) A076589 002 Oct 12, 2004
1MG/10ML (0.1MG/ML) A076589 001 Oct 12, 2004
ROMAZICON
HOFFMANN LA ROCHE 1MG/10ML (0.1MG/ML) N020073 001 Dec 20, 1991
0.5MG/5ML (0.1MG/ML) N020073 002 Dec 20, 1991
FLUMETHASONE PIVALATE
CREAM;TOPICAL
LOCORTEN
NOVARTIS 0.03% N016379 001
FLUNISOLIDE
AEROSOL, METERED;INHALATION
AEROBID
ROCHE PALO 0.25MG/INH N018340 001 Aug 17, 1984
SPRAY, METERED;NASAL
NASALIDE
IVAX RES 0.025MG/SPRAY N018148 001
NASAREL
TEVA BRANDED PHARM 0.029MG/SPRAY N020409 001 Mar 08, 1995
FLUOCINOLONE ACETONIDE
CREAM;TOPICAL
FLUOCET
ALPHARMA US PHARMS 0.025% A088360 001 Jan 16, 1984
FLUOCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.01% A088361 001 Jan 16, 1984
PERRIGO NEW YORK 0.01% A086810 001 Mar 04, 1982
0.025% A086811 001 Mar 04, 1982
PHARMADERM 0.01% A088047 001 Dec 16, 1982
0.025% A088045 001 Dec 16, 1982
PHARMAFAIR 0.01% A088499 001 Aug 02, 1984
0.025% A088506 001 Aug 02, 1984
TARO 0.01% A040035 001 Oct 31, 1994
0.01% A087102 001 Apr 27, 1982
0.025% A040042 001 Oct 31, 1994
USL PHARMA 0.01% A088757 001 Feb 11, 1985
0.025% A088756 001 Mar 28, 1985
FLUONID
ALLERGAN HERBERT 0.025% A087156 002 Sep 06, 1984
FLUOTREX
SAVAGE LABS 0.01% A088174 001 May 06, 1983
0.025% A088173 001 Mar 09, 1983
SYNALAR-HP
MEDIMETRIKS PHARMS 0.2% N016161 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-135( of 322)
FLUOCINOLONE ACETONIDE
GEL;TOPICAL
FLUONID
ALLERGAN HERBERT 0.025% A087300 001 May 27, 1982
OINTMENT;TOPICAL
FLUOCINOLONE ACETONIDE
PHARMADERM 0.025% A088046 001 Dec 16, 1982
PHARMAFAIR 0.025% A088507 001 Feb 27, 1984
USL PHARMA 0.025% A088742 001 Feb 08, 1985
FLUONID
ALLERGAN HERBERT 0.025% A087157 001 Sep 06, 1984
FLUOTREX
SAVAGE LABS 0.025% A088172 001 Mar 09, 1983
SOLUTION;TOPICAL
FLUOCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.01% A087159 001 Jun 16, 1982
BAUSCH AND LOMB 0.01% A040059 001 Dec 20, 1993
MORTON GROVE 0.01% A088312 001 Jan 27, 1984
PHARMADERM 0.01% A088048 001 Dec 16, 1982
PHARMAFAIR 0.01% A088449 001 Feb 08, 1984
FLUONID
ALLERGAN HERBERT 0.01% A087158 001 Mar 17, 1983
FLUOTREX
SAVAGE LABS 0.01% A088171 001 Mar 09, 1983
FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE
CREAM;TOPICAL
NEO-SYNALAR
MEDIMETRIKS PHARMS 0.025%;EQ 3.5MG BASE/GM A060700 001
FLUOCINONIDE
CREAM;TOPICAL
FLUOCINONIDE
PERRIGO NEW YORK 0.05% A071790 001 Jul 13, 1988
TARO 0.05% A071500 001 Jun 10, 1987
FLUOCINONIDE EMULSIFIED BASE
G AND W LABS INC 0.05% A074204 001 Jun 13, 1995
LIDEX
CNTY LINE PHARMS 0.05% **Federal Register determination N016908 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
LIDEX-E
CNTY LINE PHARMS 0.05% **Federal Register determination N016908 003
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
GEL;TOPICAL
LIDEX
CNTY LINE PHARMS 0.05% N017373 001
OINTMENT;TOPICAL
LIDEX
CNTY LINE PHARMS 0.05% N016909 002
SOLUTION;TOPICAL
FLUOCINONIDE
TARO 0.05% A072857 001 Aug 02, 1989
TEVA PHARMS 0.05% A072522 001 Sep 28, 1990
LIDEX
CNTY LINE PHARMS 0.05% N018849 001 Apr 06, 1984
FLUORESCEIN SODIUM
INJECTABLE;INJECTION
FUNDUSCEIN-25
NOVARTIS 25% N017869 001
FLUOROMETHOLONE
CREAM;TOPICAL
OXYLONE
PHARMACIA AND UPJOHN 0.025% N011748 001
SUSPENSION/DROPS;OPHTHALMIC
FLUOR-OP
NOVARTIS 0.1% A070185 001 Feb 27, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-136( of 322)
FLUOROMETHOLONE ACETATE; TOBRAMYCIN
SUSPENSION/DROPS;OPHTHALMIC
TOBRASONE
ALCON 0.1%;0.3% N050628 001 Jul 21, 1989
FLUOROMETHOLONE; SULFACETAMIDE SODIUM
SUSPENSION/DROPS;OPHTHALMIC
FML-S
ALLERGAN 0.1%;10% N019525 001 Sep 29, 1989
FLUOROURACIL
INJECTABLE;INJECTION
ADRUCIL
PHARMACIA AND UPJOHN
TEVA PARENTERAL
FLUOROURACIL
50MG/ML
50MG/ML
50MG/ML
50MG/ML
A081222 001
N017959 001
A040023 001
A081225 001
Jun 28, 1991
Oct 18, 1991
Aug 28, 1991
ABIC
ABRAXIS PHARM
BEDFORD
FRESENIUS KABI USA
MARCHAR
SMITH AND NEPHEW
SPECTRUM PHARMS
VALEANT
SOLUTION;TOPICAL
FLUOROPLEX
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
500MG/10ML (50MG/ML)
A088929 001
A089152 001
A089428 001
A089519 001
A089508 001
A040291 001
A040379 001
A087791 001
A088766 001
A088767 001
A089434 001
A087792 001
N012209 001
Mar 04, 1986
Mar 21, 1986
Jan 12, 1987
Mar 12, 1987
Jan 26, 1988
Mar 24, 1999
Nov 15, 2000
Jan 18, 1983
Dec 28, 1984
Dec 28, 1984
Mar 26, 1987
Oct 13, 1982
ELORAC 1% N016765 001
FLUOXETINE HYDROCHLORIDE
CAPSULE;ORAL
FLUOXETINE
MUTUAL PHARMA
WATSON LABS
FLUOXETINE HYDROCHLORIDE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
A075787 001
A075787 002
A075662 001
A075662 002
Jan 29, 2002
Jan 29, 2002
Jan 29, 2002
Jan 29, 2002
BARR
CARLSBAD
CR DOUBLE CRANE
PAR PHARM
SANDOZ
WOCKHARDT LTD
PROZAC
EQ 40MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
A076251 001
A076022 001
A076022 002
A076165 001
A076165 002
A076922 001
A076922 002
A075807 001
A075807 002
A078143 001
A078143 002
A078143 003
May 18, 2005
Jan 30, 2002
Jan 30, 2002
Feb 01, 2002
Feb 01, 2002
Dec 16, 2004
Dec 16, 2004
Jan 29, 2002
Jan 29, 2002
Jan 16, 2008
Jan 16, 2008
Jan 16, 2008
ELI LILLY AND CO
SOLUTION;ORAL
FLUOXETINE HYDROCHLORIDE
EQ 60MG BASE N018936 004 Jun 15, 1999
ACTAVIS MID ATLANTIC
APOTEX INC
HI TECH PHARMA
PROZAC
EQ 20MG BASE/5ML
EQ 20MG BASE/5ML
EQ 20MG BASE/5ML
A075690 001
A075292 001
A075525 001
Jan 31, 2002
Feb 07, 2002
Jun 27, 2002
LILLY
TABLET;ORAL
FLUOXETINE HYDROCHLORIDE
EQ 20MG BASE/5ML N020101 001 Apr 24, 1991
BARR
IVAX SUB TEVA PHARMS
SANDOZ
PROZAC
EQ 10MG BASE
EQ 10MG BASE
EQ 40MG BASE
EQ 10MG BASE
A075810 001
A075865 001
A075865 003
A076024 001
Feb 01, 2002
Feb 28, 2002
Aug 30, 2004
Jan 29, 2002
LILLY EQ 10MG BASE
EQ 20MG BASE
N020974 001
N020974 002
Mar 09, 1999
Mar 09, 1999
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-137( of 322)
FLUOXYMESTERONE
TABLET;ORAL
ANDROID-F
VALEANT PHARM INTL
FLUOXYMESTERONE
VALEANT PHARM INTL
WATSON LABS
HALOTESTIN
PHARMACIA AND UPJOHN
ORA-TESTRYL
BRISTOL MYERS SQUIBB
FLUPHENAZINE DECANOATE
INJECTABLE;INJECTION
FLUPHENAZINE DECANOATE
AGILA SPECLTS
HOSPIRA
TEVA PARENTERAL
PROLIXIN DECANOATE
BRISTOL MYERS SQUIBB
FLUPHENAZINE ENANTHATE
INJECTABLE;INJECTION
PROLIXIN ENANTHATE
APOTHECON
FLUPHENAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
FLUPHENAZINE HYDROCHLORIDE
TEVA PHARMS
PERMITIL
SCHERING
PROLIXIN
APOTHECON
ELIXIR;ORAL
FLUPHENAZINE HYDROCHLORIDE
TEVA PHARMS
PROLIXIN
APOTHECON
INJECTABLE;INJECTION
PROLIXIN
APOTHECON
TABLET;ORAL
FLUPHENAZINE HYDROCHLORIDE
WATSON LABS
PERMITIL
SCHERING
PROLIXIN
APOTHECON
TABLET, EXTENDED RELEASE;ORAL
PERMITIL
SCHERING
FLUPREDNISOLONE
TABLET;ORAL
ALPHADROL
PHARMACIA AND UPJOHN
10MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
5MG/ML
5MG/ML
5MG/ML
2.5MG/5ML
2.5MG/5ML
2.5MG/ML
1MG
2.5MG
5MG
10MG
0.25MG
2.5MG
5MG
10MG
1MG
2.5MG
5MG
10MG
1MG
1.5MG
A087196 001
A088221 001 May 05, 1983
A088260 001 Dec 06, 1983
A088265 001 Dec 06, 1983
A088309 001 Dec 06, 1983
N010611 002
N010611 006
N010611 010
N011359 001
N011359 002
A075918 001 Aug 17, 2001
A074966 001 Apr 16, 1998
A074795 001 Sep 10, 1996
N016727 001
N016110 001
A073058 001 Aug 30, 1991
N016008 001
A070533 001 Nov 07, 1985
A081310 001 Apr 29, 1993
N012145 003
N011751 005
A088555 001 Dec 18, 1987
A088544 001 Dec 18, 1987
A088527 001 Dec 18, 1987
A088550 001 Dec 18, 1987
N012034 001
N012034 004
N012034 005
N012034 006
N011751 004
N011751 001
N011751 003
N011751 002
N012419 004
N012259 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-138( of 322)
FLURANDRENOLIDE
LOTION;TOPICAL
FLURANDRENOLIDE
ALPHARMA US PHARMS 0.05% A087203 001 Apr 29, 1982
OINTMENT;TOPICAL
CORDRAN
AQUA PHARMS 0.025% **Federal Register determination N012806 004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
0.05% **Federal Register determination N012806 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
FLURANDRENOLIDE; NEOMYCIN SULFATE
CREAM;TOPICAL
CORDRAN-N
LILLY 0.05%;EQ 3.5MG BASE/GM N050346 001
OINTMENT;TOPICAL
CORDRAN-N
LILLY 0.05%;EQ 3.5MG BASE/GM N050345 001
FLURAZEPAM HYDROCHLORIDE
CAPSULE;ORAL
DALMANE
VALEANT PHARM INTL 15MG N016721 001
30MG N016721 002
FLURAZEPAM HYDROCHLORIDE
HALSEY 15MG A071808 001 Jan 07, 1988
30MG A071809 001 Jan 07, 1988
MUTUAL PHARM 15MG A070454 001 Aug 04, 1986
30MG A070455 001 Aug 04, 1986
PAR PHARM 15MG A070444 001 Mar 20, 1986
30MG A070445 001 Mar 20, 1986
PUREPAC PHARM 15MG A071927 001 Sep 09, 1987
30MG A071551 001 Sep 09, 1987
SANDOZ 15MG A071716 001 Jul 31, 1991
30MG A071717 001 Jul 31, 1991
SUPERPHARM 15MG A071659 001 Aug 04, 1988
30MG A071660 001 Aug 04, 1988
USL PHARMA 15MG A070562 001 Jul 09, 1987
30MG A070563 001 Jul 09, 1987
WARNER CHILCOTT 15MG A071767 001 Dec 04, 1987
30MG A071768 001 Dec 04, 1987
WATSON LABS 15MG A072368 001 Mar 30, 1989
WEST WARD 15MG A071107 001 Dec 08, 1986
30MG A071108 001 Dec 08, 1986
FLURBIPROFEN
TABLET;ORAL
FLURBIPROFEN
IVAX SUB TEVA PHARMS 50MG A074411 001 May 31, 1995
100MG A074411 002 May 31, 1995
PLIVA 50MG A074647 001 Apr 01, 1997
100MG A074647 002 Apr 01, 1997
SANDOZ 50MG A074448 001 Jul 28, 1995
100MG A074448 002 Jul 28, 1995
TEVA 50MG A074405 002 May 24, 1995
100MG A074405 001 May 24, 1995
THERAGEN 100MG A074560 002 May 16, 1997
FLUTAMIDE
CAPSULE;ORAL
EULEXIN
SCHERING 125MG N018554 001 Jan 27, 1989
FLUTAMIDE
SANDOZ 125MG A075818 001 Sep 18, 2001
FLUTICASONE PROPIONATE
AEROSOL, METERED;INHALATION
FLOVENT
GLAXOSMITHKLINE 0.044MG/INH N020548 001 Mar 27, 1996
0.11MG/INH N020548 002 Mar 27, 1996
0.22MG/INH N020548 003 Mar 27, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-139( of 322)
FLUTICASONE PROPIONATE
CREAM;TOPICAL
CUTIVATE
FOUGERA PHARMS 0.05% N019958 001 Dec 18, 1990
FLUTICASONE PROPIONATE
NESHER PHARMS 0.05% A076865 001 Sep 10, 2004
OINTMENT;TOPICAL
FLUTICASONE PROPIONATE
TARO PHARM INDS 0.005% A077145 001 Jun 14, 2005
POWDER;INHALATION
FLOVENT
GLAXOSMITHKLINE 0.044MG/INH N020549 001 Nov 07, 1997
0.088MG/INH N020549 002 Nov 07, 1997
0.22MG/INH N020549 003 Nov 07, 1997
FLUVOXAMINE MALEATE
TABLET;ORAL
FLUVOXAMINE MALEATE
ACTAVIS ELIZABETH 25MG A075901 001 Dec 28, 2000
50MG A075901 002 Dec 28, 2000
100MG A075901 003 Dec 28, 2000
CARACO 25MG A075900 001 Feb 23, 2006
50MG A075900 002 Feb 23, 2006
100MG A075900 003 Feb 23, 2006
IVAX SUB TEVA PHARMS 25MG A075898 001 Mar 12, 2001
50MG A075898 002 Mar 12, 2001
100MG A075898 003 Mar 12, 2001
MUTUAL PHARM 25MG A076125 001 Apr 29, 2002
50MG A076125 002 Apr 29, 2002
100MG A076125 003 Apr 29, 2002
MYLAN 50MG A075950 001 Oct 15, 2001
100MG A075950 002 Oct 15, 2001
SANDOZ 25MG A075887 001 Jan 05, 2001
50MG A075887 002 Jan 05, 2001
100MG A075887 003 Jan 05, 2001
SYNTHON PHARMS 25MG A075899 001 Jan 17, 2001
50MG A075899 002 Jan 17, 2001
100MG A075899 003 Jan 17, 2001
WATSON LABS 25MG A075894 001 Apr 18, 2001
50MG A075894 002 Apr 18, 2001
100MG A075894 003 Apr 18, 2001
LUVOX
SOLVAY 25MG N020243 001 Dec 05, 1994
50MG N020243 002 Dec 05, 1994
100MG N020243 003 Dec 05, 1994
150MG N020243 004 Dec 05, 1994
FOLIC ACID
INJECTABLE;INJECTION
FOLIC ACID
BEN VENUE 5MG/ML A081066 001 Dec 29, 1993
FOLVITE
HIKMA (MAPLE) 5MG/ML N005897 008
TABLET;ORAL
FOLIC ACID
BARR 1MG A089177 001 Jan 08, 1986
EVERYLIFE 1MG A080755 001
HALSEY 1MG A083598 001
IMPAX LABS 1MG A080686 001
IVAX SUB TEVA PHARMS 1MG A083000 001
LANNETT 1MG A080816 001
LILLY 1MG N006135 003
MK LABS 1MG A083526 001
MUTUAL PHARM 1MG A040582 001 Jul 18, 2005
NEXGEN PHARMA INC 1MG A084915 001
PHARMERAL 1MG A084158 001
PIONEER PHARMS 1MG A088949 001 Sep 13, 1985
PUREPAC PHARM 1MG A080784 001
SANDOZ 1MG A084472 001
TABLICAPS 1MG A083133 002
UDL 1MG A088199 001 Mar 29, 1983
USL PHARMA 1MG A087828 001 May 13, 1982
VALEANT PHARM INTL 1MG A080903 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-140( of 322)
FOLIC ACID
TABLET;ORAL
FOLIC ACID
VANGARD 1MG A088730 001 Mar 23, 1984
VINTAGE PHARMS 1MG A086296 001
WATSON LABS 1MG A083141 001
1MG A085141 002
WHITEWORTH TOWN PLSN 1MG A080691 002
FOLICET
MISSION PHARMA 1MG A087438 001
FOLVITE
HIKMA (MAPLE) 1MG N005897 004
FOLLITROPIN ALFA/BETA
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
FOLLISTIM
ORGANON USA INC 75 IU/VIAL N020582 001 Sep 29, 1997
150 IU/VIAL N020582 002 Sep 29, 1997
INJECTABLE;SUBCUTANEOUS
FOLLISTIM AQ
ORGANON USA INC 150 IU/0.18ML N021211 003 Feb 11, 2004
GONAL-F
EMD SERONO 37.5 IU/VIAL N020378 003 May 25, 2000
37.5 IU/VIAL N021765 001 Mar 25, 2004
75 IU/VIAL N020378 001 Sep 29, 1997
150 IU/VIAL N020378 002 Sep 29, 1997
150 IU/VIAL N021765 003 Mar 25, 2004
FOMIVIRSEN SODIUM
INJECTABLE;INJECTION
VITRAVENE PRESERVATIVE FREE
NOVARTIS 6.6MG/ML N020961 001 Aug 26, 1998
FORMOTEROL FUMARATE
POWDER;INHALATION
FORADIL CERTIHALER
NOVARTIS 0.0085MG/INH N021592 001 Dec 15, 2006
FOSAPREPITANT DIMEGLUMINE
POWDER;INTRAVENOUS
EMEND
MERCK AND CO INC EQ 115MG BASE/VIAL N022023 001 Jan 25, 2008
FOSINOPRIL SODIUM
TABLET;ORAL
FOSINOPRIL SODIUM
RANBAXY LABS LTD 10MG A076580 001 Apr 23, 2004
20MG A076580 002 Apr 23, 2004
40MG A076580 003 Apr 23, 2004
SANDOZ 10MG A076188 001 Oct 08, 2004
20MG A076188 002 Oct 08, 2004
40MG A076188 003 Oct 08, 2004
WATSON LABS 10MG A076987 001 Dec 23, 2004
20MG A076987 002 Dec 23, 2004
40MG A076987 003 Dec 23, 2004
MONOPRIL
BRISTOL MYERS SQUIBB 10MG N019915 002 May 16, 1991
20MG N019915 003 May 16, 1991
40MG N019915 004 Mar 28, 1995
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
TABLET;ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
MYLAN 10MG;12.5MG A077705 001 Aug 14, 2006
20MG;12.5MG A077705 002 Aug 14, 2006
TEVA 10MG;12.5MG A076945 001 Jul 05, 2006
20MG;12.5MG A076945 002 Jul 05, 2006
WATSON LABS 10MG;12.5MG A077144 001 Aug 16, 2005
20MG;12.5MG A077144 002 Aug 16, 2005
MONOPRIL-HCT
BRISTOL MYERS SQUIBB 10MG;12.5MG N020286 002 Nov 30, 1994
20MG;12.5MG N020286 001 Nov 30, 1994
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
FOSPHENYTOIN SODIUM
INJECTABLE;INJECTION
CEREBYX
PARKE DAVIS
FOSPHENYTOIN SODIUM
APOTEX INC
TEVA PHARMS USA
FOSPROPOFOL DISODIUM
SOLUTION;INTRAVENOUS
LUSEDRA
EISAI INC
FURAZOLIDONE
SUSPENSION;ORAL
FUROXONE
SHIRE
TABLET;ORAL
FUROXONE
SHIRE
FUROSEMIDE
INJECTABLE;INJECTION
FUROSEMIDE
ABRAXIS PHARM
ASTRAZENECA
HIKMA MAPLE
HOSPIRA
INTL MEDICATION
MARSAM PHARMS LLC
ORGANON USA INC
SMITH AND NEPHEW
WARNER CHILCOTT
WATSON LABS
WYETH AYERST
LASIX
SANOFI AVENTIS US
SOLUTION;ORAL
LASIX
SANOFI AVENTIS US
TABLET;ORAL
FUROSEMIDE
DAVA PHARMS INC
INTL MEDICATION
KALAPHARM
MUTUAL PHARM
SANDOZ
SUPERPHARM
WARNER CHILCOTT
WATSON LABS
DISCONTINUED DRUG PRODUCT LIST
EQ 50MG PHENYTOIN NA/ML
EQ 50MG PHENYTOIN NA/ML
EQ 50MG PHENYTOIN NA/ML
1050MG/30ML (35MG/ML)
50MG/15ML
100MG
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
20MG
40MG
80MG
20MG
40MG
20MG
40MG
20MG
40MG
80MG
40MG
20MG
40MG
20MG
40MG
80MG
20MG
40MG
40MG
6-141( of 322)
N020450 001 Aug 05, 1996
A078126 001 Aug 06, 2007
A076886 001 Aug 06, 2007
N022244 001 Dec 12, 2008
N011323 002
N011270 002
N018507 001 Jul 30, 1982
N019036 001 Aug 13, 1984
A070014 001 Sep 09, 1985
A070095 001 Sep 09, 1985
A070096 001 Sep 09, 1985
A071439 001 Sep 14, 1990
N018267 001
A070578 001 Jul 08, 1987
A072080 001 Aug 13, 1991
A074337 001 Oct 31, 1994
N018025 001
A074017 001 Jun 30, 1994
A070017 001 Dec 15, 1986
A070023 001 Feb 05, 1986
A070078 001 Feb 05, 1986
N018420 001 Feb 26, 1982
A070019 001 Sep 22, 1986
A070604 001 Jan 02, 1987
N018670 001 Jul 20, 1982
N016363 001
N017688 001
N018415 001 Jul 27, 1982
N018415 002 Jul 27, 1982
N018415 003 Nov 26, 1984
N018753 001 Feb 28, 1984
N018753 002 Feb 28, 1984
N018868 001 Jun 28, 1983
N018868 002 Jun 28, 1983
A070043 001 Sep 26, 1985
N018790 001 Nov 29, 1983
A070100 001 Jan 26, 1988
N018750 002 Jul 30, 1984
N018370 002 Jun 26, 1984
N018370 001 Feb 10, 1983
N018419 001 Jan 31, 1983
N018419 002 Jan 31, 1983
N018419 003 Nov 13, 1984
N018369 001 May 14, 1982
A070413 001 Feb 26, 1986
N018369 002 May 14, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-142( of 322)
GABAPENTIN
CAPSULE;ORAL
GABAPENTIN
IVAX SUB TEVA PHARMS 100MG A075477 001 Mar 23, 2005
300MG A075477 002 Mar 23, 2005
400MG A075477 003 Mar 23, 2005
MUTUAL PHARM 100MG A076537 001 Jun 30, 2005
300MG A076537 002 Jun 30, 2005
400MG A076537 003 Jun 30, 2005
SANDOZ 100MG A075428 001 Jan 24, 2006
100MG A075539 001 Apr 06, 2005
300MG A075428 002 Jan 24, 2006
300MG A075539 002 Apr 06, 2005
400MG A075428 003 Jan 24, 2006
400MG A075539 003 Apr 06, 2005
TABLET;ORAL
GABAPENTIN
RANBAXY 600MG A076605 001 Sep 14, 2005
800MG A076605 002 Sep 14, 2005
SANDOZ 600MG A076120 001 Jan 27, 2006
600MG A076877 001 Jul 06, 2006
800MG A076120 002 Jan 27, 2006
800MG A076877 002 Jul 06, 2006
TEVA 600MG A075827 001 Dec 15, 2004
800MG A075827 002 Dec 15, 2004
GADODIAMIDE
INJECTABLE;INJECTION
OMNISCAN
GE HEALTHCARE 14.35GM/50ML (287MG/ML) N022066 001 Sep 05, 2007
GALANTAMINE HYDROBROMIDE
TABLET;ORAL
GALANTAMINE HYDROBROMIDE
ACTAVIS ELIZABETH EQ 4MG BASE A077585 001 Sep 15, 2009
EQ 8MG BASE A077585 002 Sep 15, 2009
EQ 12MG BASE A077585 003 Sep 15, 2009
YABAO BIOPHARMS EQ 4MG BASE A077604 001 Feb 06, 2009
EQ 8MG BASE A077604 002 Feb 06, 2009
EQ 12MG BASE A077604 003 Feb 06, 2009
GALLAMINE TRIETHIODIDE
INJECTABLE;INJECTION
FLAXEDIL
DAVIS AND GECK 20MG/ML N007842 001
100MG/ML N007842 002
GALLIUM CITRATE GA-67
INJECTABLE;INJECTION
GALLIUM CITRATE GA 67
GE HEALTHCARE 1mCi/ML N017700 001
NEOSCAN
GE HEALTHCARE 2mCi/ML N017655 001
GALLIUM NITRATE
INJECTABLE;INJECTION
GANITE
CHAPTER 7 TRUSTEE 25MG/ML N019961 002 Jan 17, 1991
GANCICLOVIR
CAPSULE;ORAL
CYTOVENE
ROCHE PALO 250MG **Federal Register determination N020460 001 Dec 22, 1994
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
500MG **Federal Register determination N020460 002 Dec 12, 1997
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
GANCICLOVIR
RANBAXY LABS LTD 250MG A076457 001 Jun 27, 2003
500MG A076457 002 Jun 27, 2003
IMPLANT;IMPLANTATION
VITRASERT
BAUSCH AND LOMB 4.5MG N020569 001 Mar 04, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-143( of 322)
GANCICLOVIR SODIUM
INJECTABLE;INJECTION
GANCICLOVIR SODIUM
BEDFORD EQ 500MG BASE/VIAL A076222 001 Jul 16, 2003
GATIFLOXACIN
SOLUTION/DROPS;OPHTHALMIC
GATIFLOXACIN
APOTEX INC 0.3% A079084 001 Aug 19, 2011
GEFITINIB
TABLET;ORAL
IRESSA
ASTRAZENECA 250MG N021399 001 May 05, 2003
GEMFIBROZIL
CAPSULE;ORAL
GEMFIBROZIL
MYLAN 300MG A073466 001 Jan 25, 1993
PUREPAC PHARM 300MG A072929 001 Jan 29, 1993
LOPID
PFIZER PHARMS 200MG N018422 001
300MG N018422 002
TABLET;ORAL
GEMFIBROZIL
MYLAN 600MG A074452 001 Feb 16, 1995
PUREPAC PHARM 600MG A074360 001 Aug 31, 1994
SANDOZ 600MG A074615 001 Sep 29, 1995
WATSON LABS 600MG A074156 001 Oct 24, 1994
GEMTUZUMAB OZOGAMICIN
INJECTABLE;INJECTION
MYLOTARG
WYETH PHARMS INC 5MG/VIAL N021174 001 May 17, 2000
GENTAMICIN SULFATE
CREAM;TOPICAL
GARAMYCIN
SCHERING EQ 0.1% BASE A060462 001
GENTAFAIR
PHARMAFAIR EQ 0.1% BASE A062458 001 Sep 01, 1983
GENTAMICIN SULFATE
ALPHARMA US PHARMS EQ 0.1% BASE A062471 001 Sep 27, 1983
BAUSCH AND LOMB EQ 0.1% BASE A064056 001 Apr 29, 1994
PHARMADERM EQ 1MG BASE/GM A062530 001 Jul 05, 1984
INJECTABLE;INJECTION
APOGEN
KING PHARMS EQ 10MG BASE/ML A062289 001
EQ 40MG BASE/ML A062289 002
BRISTAGEN
BRISTOL EQ 40MG BASE/ML A062288 001
GARAMYCIN
SCHERING EQ 1MG BASE/ML A061716 002
EQ 10MG BASE/ML A061739 001
EQ 40MG BASE/ML A061716 001
GENTAFAIR
PHARMAFAIR EQ 40MG BASE/ML A062493 001 Aug 28, 1985
GENTAMICIN
INTL MEDICATION EQ 1MG BASE/ML A062325 003 Jun 23, 1982
EQ 40MG BASE/ML A062325 001
EQ 100MG BASE/100ML A062325 004 Jun 23, 1982
GENTAMICIN SULFATE
ABBOTT EQ 1.2MG BASE/ML A062413 001 Aug 11, 1983
EQ 1.4MG BASE/ML A062413 002 Aug 11, 1983
EQ 1.6MG BASE/ML A062413 003 Aug 11, 1983
EQ 1.8MG BASE/ML A062413 004 Aug 11, 1983
EQ 2MG BASE/ML A062413 005 Aug 11, 1983
EQ 60MG BASE/100ML A062413 006 Aug 11, 1983
EQ 70MG BASE/100ML A062413 007 Aug 11, 1983
EQ 80MG BASE/100ML A062413 008 Aug 11, 1983
EQ 90MG BASE/100ML A062413 009 Aug 11, 1983
EQ 100MG BASE/100ML A062413 010 Aug 11, 1983
FRESENIUS KABI USA EQ 10MG BASE/ML A062356 001 Mar 04, 1982
EQ 40MG BASE/ML A062356 002 Mar 04, 1982
HIKMA MAPLE EQ 10MG BASE/ML A062251 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-144( of 322)
GENTAMICIN SULFATE
INJECTABLE;INJECTION
GENTAMICIN SULFATE
EQ 40MG BASE/ML A062251 001
KALAPHARM EQ 40MG BASE/ML A062354 001 Apr 05, 1982
PHARM SPEC EQ 40MG BASE/ML A062340 001 Mar 28, 1983
SOLOPAK EQ 10MG BASE/ML A062507 001 Jun 06, 1985
EQ 40MG BASE/ML A062507 002 Jun 06, 1985
TEVA PARENTERAL EQ 10MG BASE/ML A063149 001 Nov 21, 1991
EQ 40MG BASE/ML A063106 002 Nov 21, 1991
WATSON LABS EQ 10MG BASE/ML A062318 002
EQ 40MG BASE/ML A062318 001
WYETH AYERST EQ 10MG BASE/ML A062264 001
EQ 40MG BASE/ML A062264 002
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA EQ 1.2MG BASE/ML A062588 001 Jan 06, 1986
EQ 1.4MG BASE/ML A062588 002 Jan 06, 1986
EQ 1.6MG BASE/ML A062588 003 Jan 06, 1986
EQ 1.8MG BASE/ML A062588 004 Jan 06, 1986
EQ 2MG BASE/ML A062588 005 Jan 06, 1986
EQ 60MG BASE/100ML A062588 006 Jan 06, 1986
EQ 70MG BASE/100ML A062588 007 Jan 06, 1986
EQ 80MG BASE/100ML A062588 008 Jan 06, 1986
EQ 90MG BASE/100ML A062588 009 Jan 06, 1986
EQ 100MG BASE/100ML A062588 010 Jan 06, 1986
U-GENCIN
PHARMACIA AND UPJOHN EQ 10MG BASE/ML A062248 001
EQ 40MG BASE/ML A062248 002
INJECTABLE;INTRATHECAL
GARAMYCIN
SCHERING EQ 2MG BASE/ML N050505 001
OINTMENT;OPHTHALMIC
GARAMYCIN
SCHERING EQ 0.3% BASE N050425 001
GENTACIDIN
NOVARTIS EQ 0.3% BASE A062501 001 Jul 26, 1984
GENTAFAIR
PHARMAFAIR EQ 3MG BASE/GM A062443 001 May 26, 1983
OINTMENT;TOPICAL
GARAMYCIN
SCHERING EQ 0.1% BASE A060463 001
GENTAFAIR
PHARMAFAIR EQ 0.1% BASE A062444 001 May 26, 1983
GENTAMICIN SULFATE
ALPHARMA US PHARMS EQ 0.1% BASE A062496 001 Mar 14, 1984
BAUSCH AND LOMB EQ 0.1% BASE A064054 001 Apr 29, 1994
PHARMADERM EQ 0.1% BASE A062534 001 Oct 10, 1984
SOLUTION/DROPS;OPHTHALMIC
GARAMYCIN
SCHERING EQ 0.3% BASE N050039 002
GENTACIDIN
NOVARTIS EQ 0.3% BASE A062480 001 Mar 30, 1984
GENTAFAIR
PHARMAFAIR EQ 0.3% BASE A062440 001 May 03, 1983
GENTAMICIN SULFATE
ALCON PHARMS LTD EQ 0.3% BASE A062523 001 Nov 25, 1985
PACO EQ 3MG BASE/ML A062932 001 Nov 07, 1988
GENTIAN VIOLET
SUPPOSITORY;VAGINAL
GVS
SAVAGE LABS 0.4% A083513 001
TAMPON;VAGINAL
GENAPAX
KEY PHARMS 5MG A085017 001
GLATIRAMER ACETATE
FOR SOLUTION;SUBCUTANEOUS
COPAXONE
TEVA PHARMS USA 20MG/VIAL N020622 001 Dec 20, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
GLIMEPIRIDE
TABLET;ORAL
GLIMEPIRIDE
COREPHARMA 1MG
2MG
4MG
MYLAN 1MG
2MG
4MG
RANBAXY 3MG
6MG
RANBAXY LABS LTD 1MG
2MG
4MG
8MG
GLIPIZIDE
TABLET;ORAL
GLIPIZIDE
BARR LABS INC 5MG
10MG
SANDOZ 5MG
10MG
TEVA 5MG
10MG
VINTAGE PHARMS LLC 5MG
10MG
GLUCOTROL
PFIZER 2.5MG
GLIPIZIDE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
METAGLIP
BRISTOL MYERS SQUIBB 2.5MG;250MG
2.5MG;500MG
5MG;500MG
GLUCAGON HYDROCHLORIDE
INJECTABLE;INJECTION
GLUCAGON
LILLY EQ 1MG BASE/VIAL
EQ 10MG BASE/VIAL
GLUTETHIMIDE
CAPSULE;ORAL
DORIDEN
SANOFI AVENTIS US 500MG
TABLET;ORAL
DORIDEN
SANOFI AVENTIS US 250MG
500MG
GLUTETHIMIDE
HALSEY 250MG
500MG
LANNETT 250MG
500MG
SANDOZ 500MG
UCB INC 500MG
VITARINE 500MG
WATSON LABS 500MG
500MG
GLYBURIDE
TABLET;ORAL
GLYBURIDE
ACTAVIS TOTOWA 1.5MG
3MG
6MG
GLYBURIDE (MICRONIZED)
SANDOZ 1.5MG
3MG
SANOFI AVENTIS US 1.5MG
3MG
6MG
6-145( of 322)
A077274 001 Oct 06, 2005
A077274 002 Oct 06, 2005
A077274 003 Oct 06, 2005
A077486 001 Feb 10, 2006
A077486 002 Feb 10, 2006
A077486 003 Feb 10, 2006
A077366 001 Oct 06, 2005
A077366 002 Oct 06, 2005
A076875 001 Oct 06, 2005
A076875 002 Oct 06, 2005
A076875 003 Oct 06, 2005
A076875 004 Oct 06, 2005
A074619 001 Apr 04, 1997
A074619 002 Apr 04, 1997
A074542 001 Jun 20, 1995
A074542 002 Jun 20, 1995
A074387 001 Mar 04, 1996
A074387 002 Mar 04, 1996
A074378 001 Nov 28, 1994
A074378 002 Nov 28, 1994
N017783 003 May 11, 1993
N021460 001 Oct 21, 2002
N021460 002 Oct 21, 2002
N021460 003 Oct 21, 2002
N012122 001
N012122 002
N009519 008
N009519 002
N009519 005
A089458 001 Oct 10, 1986
A089459 001 Oct 10, 1986
A083475 001
A085571 001
A083234 002
A085171 001
A087297 001
A084362 001
A085763 001
A075947 001 Nov 14, 2002
A075947 002 Nov 14, 2002
A075947 003 Nov 14, 2002
A075174 001 Jun 22, 1998
A075174 002 Jun 22, 1998
N020055 001 Apr 17, 1992
N020055 002 Apr 17, 1992
N020055 003 Mar 08, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-146( of 322)
GLYBURIDE
TABLET;ORAL
GLYNASE
PHARMACIA AND UPJOHN 4.5MG N020051 003 Sep 24, 1993
MICRONASE
PHARMACIA AND UPJOHN 1.25MG N017498 001 May 01, 1984
2.5MG N017498 002 May 01, 1984
5MG N017498 003 May 01, 1984
GLYBURIDE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDE
TEVA 1.25MG;250MG A076821 001 Jan 27, 2005
2.5MG;500MG A076821 002 Jan 27, 2005
5MG;500MG A076821 003 Jan 27, 2005
GLYCINE
SOLUTION;IRRIGATION
GLYCINE 1.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 1.5GM/100ML N018522 001 Feb 19, 1982
HOSPIRA 1.5GM/100ML N017633 001
GLYCOPYRROLATE
INJECTABLE;INJECTION
GLYCOPYRROLATE
ABRAXIS PHARM 0.2MG/ML A088475 001 Jun 12, 1984
HOSPIRA 0.2MG/ML A089393 001 Jun 15, 1988
TEVA PARENTERAL 0.2MG/ML A081169 001 Sep 10, 1991
WATSON LABS 0.2MG/ML A086947 001 Jun 24, 1983
ROBINUL
ROBINS AH 0.2MG/ML N014764 001
TABLET;ORAL
GLYCOPYRROLATE
COREPHARMA 1MG A040568 001 Dec 22, 2004
2MG A040568 002 Dec 22, 2004
WATSON LABS 1MG A085562 001
1MG A086902 001
2MG A085563 001
2MG A086178 001
2MG A086900 001
WEST WARD 1MG A040836 001 Mar 05, 2009
2MG A040836 002 Mar 05, 2009
GONADORELIN ACETATE
INJECTABLE;INJECTION
LUTREPULSE KIT
FERRING 0.8MG/VIAL N019687 001 Oct 10, 1989
3.2MG/VIAL N019687 002 Oct 10, 1989
GONADORELIN HYDROCHLORIDE
INJECTABLE;INJECTION
FACTREL
HIKMA (MAPLE) EQ 0.1MG BASE/VIAL N018123 001 Sep 30, 1982
EQ 0.2MG BASE/VIAL N018123 002 Sep 30, 1982
EQ 0.5MG BASE/VIAL N018123 003 Sep 30, 1982
GONADOTROPIN, CHORIONIC
INJECTABLE;INJECTION
A.P.L.
FERRING 5,000 UNITS/VIAL N017055 001
10,000 UNITS/VIAL N017055 002
20,000 UNITS/VIAL N017055 003
CHORIONIC GONADOTROPIN
BEL MAR 5,000 UNITS/VIAL N017054 001
10,000 UNITS/VIAL N017054 002
FERRING 2,000 UNITS/VIAL N017016 009 Dec 27, 1984
2,000 UNITS/VIAL N017016 011 Feb 16, 1990
5,000 UNITS/VIAL N017016 006
15,000 UNITS/VIAL N017016 010 Feb 15, 1985
20,000 UNITS/VIAL N017016 004
FRESENIUS KABI USA 5,000 UNITS/VIAL N017067 001
15,000 UNITS/VIAL N017067 004
20,000 UNITS/VIAL N017067 003
FOLLUTEIN
BRISTOL MYERS SQUIBB 10,000 UNITS/VIAL N017056 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SOLUTION/DROPS;OPHTHALMIC
NEO-POLYCIN
DOW PHARM 0.025MG/ML;EQ 1.75MG BASE/ML;10,000
UNITS/ML
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
IPHARM 0.025MG/ML;EQ 1.75MG BASE/ML;10,000
UNITS/ML
WATSON LABS 0.025MG/ML;EQ 1.75MG BASE/ML;10,000
UNITS/ML
NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN
PHARMAFAIR
GRANISETRON HYDROCHLORIDE
INJECTABLE;INJECTION
GRANISETRON HYDROCHLORIDE
APOTEX INC
EBEWE PHARMA
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
0.025MG/ML;EQ 1.75MG BASE/ML;10,000
UNITS/ML
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
TEVA PHARMS USA
KYTRIL
ROCHE
SOLUTION;ORAL
KYTRIL
ROCHE
TABLET;ORAL
GRANISETRON HYDROCHLORIDE
BARR
KYTRIL
ROCHE
GREPAFLOXACIN HYDROCHLORIDE
TABLET;ORAL
RAXAR
OTSUKA
GRISEOFULVIN, MICROCRYSTALLINE
CAPSULE;ORAL
GRISACTIN
WYETH AYERST
SUSPENSION;ORAL
GRIFULVIN V
JOHNSON AND JOHNSON
TABLET;ORAL
FULVICIN-U/F
ELORAC
GRIFULVIN V
J AND J
VALEANT LUXEMBOURG
GRISACTIN
WYETH AYERST
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 3MG BASE/ML
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EQ 2MG BASE/10ML
EQ 1MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 200MG BASE
EQ 400MG BASE
EQ 600MG BASE
125MG
250MG
125MG/5ML
250MG
500MG
125MG
250MG
500MG
125MG
250MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
500MG
GRISEOFULVIN, ULTRAMICROCRYSTALLINE
TABLET;ORAL
FULVICIN P/G
ELORAC 125MG
250MG
A060427 001
A062818 001
A062788 001
A062383 001
A078197 001
A078198 001
A078198 002
A078808 001
A077165 001
N020239 003
N020239 004
N020239 001
N020239 002
N021238 001
A078221 001
N020305 001
N020305 002
N020695 001
N020695 002
N020695 003
N050051 002
N050051 001
N050448 001
A060569 002
A060569 001
A060618 001
A060618 002
A060618 003
A062279 001
A062279 002
A060212 001
A061996 001
A061996 002
6-147( of 322)
Oct 11, 1988
Jun 11, 1987
Aug 31, 1982
Dec 31, 2007
Jun 30, 2008
Jun 30, 2008
Apr 29, 2008
Dec 31, 2007
Sep 17, 2004
Mar 11, 1994
Dec 29, 1993
Mar 11, 1994
Jun 27, 2001
Dec 31, 2007
Mar 16, 1995
Jun 15, 1998
Nov 06, 1997
May 14, 1998
May 14, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
GRISEOFULVIN, ULTRAMICROCRYSTALLINE
TABLET;ORAL
FULVICIN P/G 165
ELORAC
FULVICIN P/G 330
ELORAC
GRISACTIN ULTRA
WYETH AYERST
ULTRAGRIS-165
PLIVA
ULTRAGRIS-330
PLIVA
GUANABENZ ACETATE
TABLET;ORAL
GUANABENZ ACETATE
SANDOZ
TEVA PHARMS
WATSON LABS
WYTENSIN
WYETH AYERST
GUANADREL SULFATE
TABLET;ORAL
HYLOREL
PHARMACIA AND UPJOHN
GUANETHIDINE MONOSULFATE
TABLET;ORAL
GUANETHIDINE MONOSULFATE
WATSON LABS
ISMELIN
NOVARTIS
165MG
330MG
125MG
165MG
250MG
330MG
165MG
330MG
EQ 4MG BASE
EQ 8MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 16MG BASE
10MG
25MG
EQ 10MG SULFATE
EQ 25MG SULFATE
EQ 10MG SULFATE
EQ 25MG SULFATE
GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
ESIMIL
NOVARTIS
GUANFACINE HYDROCHLORIDE
TABLET;ORAL
GUANFACINE HYDROCHLORIDE
WATSON LABS
TENEX
PROMIUS PHARMA
HALAZEPAM
TABLET;ORAL
PAXIPAM
SCHERING
HALCINONIDE
CREAM;TOPICAL
HALOG
WESTWOOD SQUIBB
HALOG-E
RANBAXY
OINTMENT;TOPICAL
HALOG
BRISTOL MYERS SQUIBB
10MG;25MG
EQ 1MG BASE
EQ 2MG BASE
EQ 3MG BASE
20MG
40MG
0.025%
0.1%
0.025%
6-148( of 322)
A061996 003 Apr 06, 1982
A061996 004 Apr 06, 1982
A062178 001
A062438 001 Nov 17, 1983
A062178 002
A062438 002 Nov 17, 1983
A062645 001 Jun 30, 1992
A062646 001 Jun 30, 1992
A074517 001 Sep 30, 1998
A074517 002 Sep 30, 1998
A074267 001 Jun 01, 1994
A074267 002 Jun 01, 1994
A074025 001 Feb 28, 1994
A074025 002 Feb 28, 1994
N018587 001 Sep 07, 1982
N018587 002 Sep 07, 1982
N018587 003 Sep 07, 1982
N018104 001 Dec 29, 1982
N018104 002 Dec 29, 1982
A086113 001 Mar 26, 1985
A086114 001 Mar 26, 1985
N012329 001
N012329 002
N013553 001
A074762 001 Jun 25, 1997
A074762 002 Jun 25, 1997
N019032 003 Nov 07, 1988
N017736 003
N017736 004
N017818 001
N018234 001
N018125 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
HALCINONIDE
SOLUTION;TOPICAL
HALOG
RANBAXY 0.1%
HALOBETASOL PROPIONATE
OINTMENT;TOPICAL
HALOBETASOL PROPIONATE
FOUGERA PHARMS 0.05%
G AND W LABS INC 0.05%
TARO 0.05%
HALOFANTRINE HYDROCHLORIDE
TABLET;ORAL
HALFAN
GLAXOSMITHKLINE 250MG
HALOPERIDOL
TABLET;ORAL
HALDOL
ORTHO MCNEIL 0.5MG
1MG
2MG
5MG
10MG
20MG
HALDOL SOLUTAB
ORTHO MCNEIL PHARM 1MG
HALOPERIDOL
DURAMED PHARMS BARR 0.5MG
1MG
2MG
5MG
10MG
20MG
LEDERLE 0.5MG
1MG
2MG
5MG
10MG
20MG
MUTUAL PHARM 0.5MG
1MG
2MG
5MG
10MG
20MG
PAR PHARM 20MG
PUREPAC PHARM 0.5MG
1MG
2MG
5MG
10MG
20MG
QUANTUM PHARMICS 0.5MG
1MG
2MG
5MG
ROXANE 0.5MG
1MG
2MG
5MG
10MG
20MG
ROYCE LABS 0.5MG
1MG
2MG
5MG
10MG
20MG
SCS 0.5MG
1MG
2MG
5MG
6-149( of 322)
N017823 001
A076903 001 Dec 16, 2004
A077109 001 Jun 14, 2005
A076994 001 Dec 16, 2004
N020250 001 Jul 24, 1992
N015921 001
N015921 002
N015921 003
N015921 004
N015921 005
N015921 006 Feb 02, 1982
N017079 001
A071216 001 Dec 04, 1986
A071217 001 Dec 04, 1986
A071218 001 Dec 04, 1986
A071219 001 Dec 04, 1986
A071220 001 Jul 07, 1987
A071221 001 Jul 07, 1987
A072727 001 Sep 19, 1989
A072728 001 Sep 19, 1989
A072729 001 Sep 19, 1989
A072730 001 Sep 19, 1989
A072731 001 Sep 19, 1989
A072732 001 Sep 19, 1989
A071156 001 Jan 02, 1987
A071157 001 Jan 02, 1987
A071172 001 Jan 02, 1987
A071212 001 Jan 07, 1988
A071173 001 Jan 07, 1988
A071177 001 Jan 07, 1988
A071328 001 Jul 20, 1987
A071071 001 Nov 03, 1986
A071072 001 Nov 03, 1986
A071073 001 Nov 03, 1986
A071074 001 Nov 03, 1986
A071075 001 Aug 04, 1987
A071076 001 Aug 04, 1987
A071255 001 Feb 17, 1987
A071269 001 Feb 17, 1987
A071256 001 Feb 17, 1987
A071257 001 Feb 17, 1987
A071128 001 Feb 17, 1987
A071129 001 Feb 17, 1987
A071130 001 Feb 17, 1987
A071131 001 Feb 17, 1987
A071132 001 May 12, 1987
A071133 001 May 12, 1987
A071722 001 Dec 24, 1987
A071723 001 Dec 24, 1987
A071724 001 Dec 24, 1987
A071725 001 Dec 24, 1987
A072121 001 Dec 24, 1987
A072122 001 Dec 24, 1987
A070720 001 Jun 10, 1986
A070721 001 Jun 10, 1986
A070722 001 Jun 10, 1986
A070723 001 Jun 10, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
HALOPERIDOL
TABLET;ORAL
HALOPERIDOL
10MG
20MG
VINTAGE 0.5MG
1MG
2MG
5MG
10MG
WATSON LABS 0.5MG
0.5MG
1MG
1MG
2MG
2MG
5MG
5MG
10MG
10MG
20MG
20MG
HALOPERIDOL DECANOATE
INJECTABLE;INJECTION
HALOPERIDOL DECANOATE
AGILA SPECLTS EQ 50MG BASE/ML
EQ 100MG BASE/ML
HOSPIRA EQ 50MG BASE/ML
EQ 100MG BASE/ML
SANDOZ EQ 50MG BASE/ML
EQ 100MG BASE/ML
HALOPERIDOL LACTATE
CONCENTRATE;ORAL
HALDOL
ORTHO MCNEIL EQ 2MG BASE/ML
HALOPERIDOL
ALPHARMA EQ 2MG BASE/ML
MORTON GROVE EQ 2MG BASE/ML
SCS EQ 2MG BASE/ML
TEVA EQ 2MG BASE/ML
HALOPERIDOL INTENSOL
ROXANE EQ 2MG BASE/ML
INJECTABLE;INJECTION
HALOPERIDOL
ABRAXIS PHARM EQ 5MG BASE/ML
APOTEX INC EQ 5MG BASE/ML
EQ 5MG BASE/ML
MARSAM PHARMS LLC EQ 5MG BASE/ML
EQ 5MG BASE/ML
SANDOZ EQ 5MG BASE/ML
SMITH AND NEPHEW EQ 5MG BASE/ML
SOLOPAK EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
WATSON LABS EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
SOLUTION;ORAL
HALOPERIDOL LACTATE
ACTAVIS MID ATLANTIC EQ 1MG BASE/ML
HALOPROGIN
CREAM;TOPICAL
HALOTEX
WESTWOOD SQUIBB 1%
SOLUTION;TOPICAL
HALOTEX
WESTWOOD SQUIBB 1%
6-150( of 322)
A070724 001 Jun 10, 1986
A070725 001 Sep 24, 1986
A071233 001 Nov 03, 1986
A071234 001 Nov 03, 1986
A071235 001 Nov 03, 1986
A071236 001 Nov 03, 1986
A071237 001 Jul 20, 1987
A070981 001 Mar 06, 1987
A071571 001 Jun 03, 1988
A070982 001 Mar 06, 1987
A071572 001 Jun 03, 1988
A070983 001 Mar 06, 1987
A071573 001 Jun 03, 1988
A070984 001 Mar 06, 1987
A071374 001 Jun 03, 1988
A071375 001 Jun 03, 1988
A072113 001 Aug 27, 1991
A071376 001 Jun 03, 1988
A072353 001 Aug 27, 1991
A075440 001 Feb 28, 2000
A075440 002 Feb 28, 2000
A075176 001 Feb 09, 2000
A075176 002 Feb 09, 2000
A076463 001 Jun 24, 2005
A076463 002 Jun 24, 2005
N015922 001
A070318 001 Apr 11, 1986
A070710 001 Mar 07, 1986
A070726 001 Jun 10, 1986
A071015 001 Aug 25, 1987
A072045 001 Apr 12, 1988
A071187 001 Jan 20, 1987
A076791 001 Aug 25, 2004
A076828 001 Aug 25, 2004
A072516 001 Feb 25, 1993
A072517 001 Feb 25, 1993
A076464 001 Sep 29, 2004
A070802 001 Dec 14, 1987
A070800 001 Dec 14, 1987
A070801 001 Dec 14, 1987
A070864 001 Dec 14, 1987
A070713 001 May 17, 1988
A070714 001 May 17, 1988
A070744 001 May 17, 1988
A074536 001 Nov 02, 1995
N016942 001
N016943 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
HALOTHANE
LIQUID;INHALATION
FLUOTHANE
WYETH AYERST
HALOTHANE
BH
HALOCARBON
HOSPIRA
HEPARIN CALCIUM
INJECTABLE;INJECTION
CALCIPARINE
SANOFI AVENTIS US
HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN LOCK FLUSH
HOSPIRA
INTL MEDICATION
LUITPOLD
PARKE DAVIS
SMITH AND NEPHEW
SOLOPAK
HEPARIN SODIUM
ABRAXIS PHARM
AKORN
BAXTER HLTHCARE CORP
CHAMBERLIN PARENTERL
DELL LABS
FRESENIUS KABI USA
HIKMA MAPLE
HOSPIRA
LILLY
LUITPOLD
99.99%
99.99%
99.99%
99.99%
25,000 UNITS/ML
100 UNITS/ML
10 UNITS/ML
500 UNITS/ML
10 UNITS/ML
100 UNITS/ML
10 UNITS/ML
10 UNITS/ML
10 UNITS/ML
10 UNITS/ML
10 UNITS/ML
100 UNITS/ML
100 UNITS/ML
100 UNITS/ML
100 UNITS/ML
10 UNITS/ML
10 UNITS/ML
100 UNITS/ML
100 UNITS/ML
1,000 UNITS/ML
1,000 UNITS/ML
5,000 UNITS/ML
10,000 UNITS/ML
1,000 UNITS/ML
5,000 UNITS/ML
10,000 UNITS/ML
20,000 UNITS/ML
40,000 UNITS/ML
1,000 UNITS/ML
2,500 UNITS/ML
5,000 UNITS/ML
5,000 UNITS/0.5ML
7,500 UNITS/ML
10,000 UNITS/ML
15,000 UNITS/ML
20,000 UNITS/ML
1,000 UNITS/ML
5,000 UNITS/ML
10,000 UNITS/ML
20,000 UNITS/ML
1,000 UNITS/ML
5,000 UNITS/ML
10,000 UNITS/ML
20,000 UNITS/ML
40,000 UNITS/ML
1,000 UNITS/ML
5,000 UNITS/ML
10,000 UNITS/ML
20,000 UNITS/ML
5,000 UNITS/0.5ML
2,500 UNITS/ML
10,000 UNITS/ML
1,000 UNITS/ML
10,000 UNITS/ML
20,000 UNITS/ML
1,000 UNITS/ML
6-151( of 322)
N011338 001
A084977 001
A080810 001
A083254 001
N018237 001
N005264 010
A086357 001
A086357 002
A089063 001 Oct 09, 1985
A089064 001 Oct 09, 1985
N017346 006
A087904 001 Apr 20, 1983
A087958 001 Apr 20, 1983
A088458 001 Jul 26, 1984
A088580 001 Oct 25, 1984
A087906 001 Apr 20, 1983
A087959 001 Apr 20, 1983
A088460 001 Jul 26, 1984
A088581 001 Oct 25, 1984
A087903 001 Apr 20, 1983
A088457 001 Oct 25, 1984
A087905 001 Apr 20, 1983
A088459 001 Jul 26, 1984
N017033 001
N017979 001
N017979 003
N017979 002
N017486 001
N017486 002
N017486 003
N017486 004
N017486 005
N017007 001
N017007 007
N017007 002
N017007 010
N017007 003
N017007 004
N017007 005
N017007 006
N017130 001
N017130 002
N017130 003
N017130 004
N017540 001
N017540 002
N017540 003
N017540 004
N017540 005
N017651 005
N017029 002
N017651 003
N017651 008
N017037 013 Apr 07, 1986
A088099 001 Apr 28, 1983
A040095 001 Jul 26, 1996
N005521 001
N005521 002
N005521 004
A087452 001 Oct 31, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN SODIUM
MARSAM PHARMS LLC
ORGANON USA INC
PARKE DAVIS
PHARM SPEC
PHARMACIA AND UPJOHN
SMITH AND NEPHEW
SOLOPAK
WATSON LABS
HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW 200 UNITS/100ML
1,000 UNITS/ML
1,000 UNITS/ML
1,000 UNITS/ML
5,000 UNITS/ML
10,000 UNITS/ML
1,000 UNITS/ML
5,000 UNITS/ML
7,500 UNITS/ML
10,000 UNITS/ML
20,000 UNITS/ML
1,000 UNITS/ML
5,000 UNITS/ML
10,000 UNITS/ML
20,000 UNITS/ML
40,000 UNITS/ML
1,000 UNITS/ML
5,000 UNITS/ML
10,000 UNITS/ML
1,000 UNITS/ML
1,000 UNITS/ML
5,000 UNITS/ML
5,000 UNITS/0.5ML
10,000 UNITS/ML
10,000 UNITS/0.5ML
1,000 UNITS/ML
2,500 UNITS/ML
3,000 UNITS/ML
4,000 UNITS/ML
5,000 UNITS/ML
6,000 UNITS/ML
7,500 UNITS/ML
10,000 UNITS/ML
20,000 UNITS/ML
40,000 UNITS/ML
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 200 UNITS/100ML N019042 001 Mar 29, 1985
HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML N019802 001 Jul 20, 1992
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 5,000 UNITS/100ML N018911 005 Jan 30, 1985
5,000 UNITS/100ML N018916 003 Jan 31, 1984
HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW 200 UNITS/100ML N019130 003 Dec 31, 1984
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2,000 UNITS/100ML
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%
HOSPIRA 10,000 UNITS/100ML
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
HOSPIRA 10,000 UNITS/100ML
10,000 UNITS/100ML
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 10,000 UNITS/100ML
10,000 UNITS/100ML
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5%
HOSPIRA 5,000 UNITS/100ML
6-152( of 322)
A040007 001 Jun 07, 1996
A040008 001 Oct 10, 1995
N000552 008
N000552 009
N000552 010
N017346 001
N017346 002
N017346 003
N017346 004
N017346 005
N017780 001
N017780 002
N017780 003
N017780 004
N017780 005
N004570 001
N004570 002
N004570 003
A088239 001 Jul 26, 1984
A087043 001
A087077 001
A087395 001
A087107 001
A087363 001
N017064 002
N017064 015
N017064 016
N017064 017
N017064 003
N017064 018
N017064 019
N017064 004
N017064 005
N017064 006
N019130 001 Dec 31, 1984
N018814 002 Jul 09, 1985
N018911 006 Jan 30, 1985
N018911 001 Jan 30, 1985
N018916 005 Jan 31, 1984
N018911 003 Jan 30, 1985
N018916 002 Jan 31, 1984
N018911 007 Jan 30, 1985
B BRAUN 200 UNITS/100ML
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4,000 UNITS/100ML
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5,000 UNITS/100ML
10,000 UNITS/100ML
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
HOSPIRA 5,000 UNITS/100ML
10,000 UNITS/100ML
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML
N019042 002 Mar 29, 1985
N018814 001 Oct 31, 1983
N018814 003 Jul 09, 1985
N018814 004 Jul 02, 1987
N018911 009 Jan 30, 1985
N018911 008 Jan 30, 1985
N019134 001 Mar 29, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-153( of 322)
HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML N019802 005 Jul 20, 1992
10,000 UNITS/100ML N019802 002 Jul 20, 1992
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 5,000 UNITS/100ML N018911 004 Jan 30, 1985
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML N019135 001 Mar 29, 1985
5,000 UNITS/100ML N019802 003 Jul 20, 1992
HOSPIRA 5,000 UNITS/100ML N018916 009 Jan 31, 1984
HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE 500 UNITS/100ML N018609 003 Apr 28, 1982
HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW 1,000 UNITS/100ML N019130 002 Dec 31, 1984
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
HOSPIRA 100 UNITS/ML N018911 002 Jan 30, 1985
100 UNITS/ML N018916 004 Jan 31, 1984
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 1,000 UNITS/100ML N018916 001 Jan 31, 1984
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 1,000 UNITS/100ML N019042 004 Mar 29, 1985
HEPARIN SODIUM PRESERVATIVE FREE
HOSPIRA 2,000 UNITS/ML N005264 013 Apr 07, 1986
2,500 UNITS/ML N005264 014 Apr 07, 1986
MARSAM PHARMS LLC 1,000 UNITS/ML A089464 001 Jun 03, 1986
PHARMA SERVE NY 1,000 UNITS/ML A086129 001
LIPO-HEPIN
3M 1,000 UNITS/0.5ML N017027 001
1,000 UNITS/ML N017027 006
5,000 UNITS/0.5ML N017027 002
5,000 UNITS/ML N017027 008
7,500 UNITS/0.5ML N017027 010
10,000 UNITS/0.5ML N017027 003
10,000 UNITS/ML N017027 009
15,000 UNITS/0.5ML N017027 011
20,000 UNITS/0.5ML N017027 004
20,000 UNITS/ML N017027 007
40,000 UNITS/ML N017027 005
LIQUAEMIN LOCK FLUSH
ORGANON USA INC 100 UNITS/ML N000552 007
LIQUAEMIN SODIUM
ORGANON USA INC 1,000 UNITS/ML N000552 004
5,000 UNITS/ML N000552 003
10,000 UNITS/ML N000552 005
20,000 UNITS/ML N000552 001
40,000 UNITS/ML N000552 002
LIQUAEMIN SODIUM PRESERVATIVE FREE
ORGANON USA INC 1,000 UNITS/ML N000552 011 Apr 11, 1986
5,000 UNITS/ML N000552 012 Apr 11, 1986
10,000 UNITS/ML N000552 013 Apr 11, 1986
PANHEPRIN
HOSPIRA 1,000 UNITS/ML N005264 004
5,000 UNITS/ML N005264 006
10,000 UNITS/ML N005264 007
20,000 UNITS/ML N005264 008
40,000 UNITS/ML N005264 009
SODIUM HEPARIN
ABRAXIS PHARM 5,000 UNITS/ML N017033 002
10,000 UNITS/ML N017033 003
20,000 UNITS/ML N017033 004
BAXTER HLTHCARE 1,000 UNITS/ML N017036 001 Mar 04, 1988
HETACILLIN
FOR SUSPENSION;ORAL
VERSAPEN
BRISTOL EQ 112.5MG AMPICIL/ML A061398 001
EQ 112.5MG AMPICIL/5ML N050060 001
EQ 112.5MG AMPICIL/ML N050060 003
EQ 225MG AMPICIL/5ML A061398 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
HETACILLIN POTASSIUM
CAPSULE;ORAL
VERSAPEN-K
BRISTOL EQ 225MG AMPICIL
EQ 450MG AMPICIL
HEXACHLOROPHENE
AEROSOL;TOPICAL
SEPTISOL
VESTAL LABS 0.23%
TURGEX
XTTRIUM 3%
EMULSION;TOPICAL
HEXA-GERM
HUNTINGTON LABS 3%
PHISOHEX
SANOFI AVENTIS US 3%
SOY-DOME
BAYER PHARMS 3%
TURGEX
XTTRIUM 3%
SOAP;TOPICAL
GAMOPHEN
ARBROOK 2%
SOLUTION;TOPICAL
DIAL
DIAL 0.25%
GERMA-MEDICA
HUNTINGTON LABS 1%
GERMA-MEDICA "MG"
HUNTINGTON LABS 0.25%
SEPTI-SOFT
CALGON 0.25%
SEPTISOL
VESTAL LABS 0.25%
SPONGE;TOPICAL
E-Z SCRUB
BECTON DICKINSON 450MG
HEXASCRUB
PROF DSPLS 3%
PHISO-SCRUB
SANOFI AVENTIS US 3%
SCRUBTEAM SURGICAL SPONGEBRUSH
3M 330MG
HEXAFLUORENIUM BROMIDE
INJECTABLE;INJECTION
MYLAXEN
MEDPOINTE PHARM HLC 20MG/ML
HEXOCYCLIUM METHYLSULFATE
TABLET;ORAL
TRAL
ABBVIE 25MG
HEXYLCAINE HYDROCHLORIDE
SOLUTION;TOPICAL
CYCLAINE
MERCK 5%
HISTAMINE PHOSPHATE
INJECTABLE;INJECTION
HISTAMINE PHOSPHATE
LILLY EQ 0.1MG BASE/ML
EQ 0.2MG BASE/ML
EQ 1MG BASE/ML
HISTRELIN ACETATE
INJECTABLE;INJECTION
SUPPRELIN
SHIRE EQ 0.2MG BASE/ML
EQ 0.5MG BASE/ML
EQ 1MG BASE/ML
6-154( of 322)
A061396 001
A061396 002
N017424 001
N018375 001
N017411 001
N008402 001
N017405 001
N019055 001 Nov 30, 1984
N006270 003
N017421 002
N017412 001
N017412 002
N017460 001
N017423 001
N017452 001
N018363 001
N017446 001
N017413 001
N009789 003
N010599 001
N008472 001
N000734 003
N000734 002
N000734 001
N019836 001 Dec 24, 1991
N019836 002 Dec 24, 1991
N019836 003 Dec 24, 1991
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-155( of 322)
HOMATROPINE METHYLBROMIDE
TABLET;ORAL
HOMAPIN-10
MISSION PHARMA 10MG A086308 001
HOMAPIN-5
MISSION PHARMA 5MG A086309 001
TABLET, CHEWABLE;ORAL
EQUIPIN
MISSION PHARMA 3MG A086310 001
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
SYRUP;ORAL
HYCODAN
ENDO PHARMS 1.5MG/5ML;5MG/5ML N005213 002 Jul 26, 1988
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
IVAX SUB TEVA PHARMS
HYDROPANE
1.5MG/5ML;5MG/5ML A040285 001 Jul 19, 1999
HALSEY 1.5MG/5ML;5MG/5ML
TABLET;ORAL
HOMATROPRINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
A088066 001 Jun 28, 1985
ACTAVIS TOTOWA
HYCODAN
1.5MG;5MG A040295 001 Dec 01, 2000
ENDO PHARMS 1.5MG;5MG N005213 001 Jul 26, 1988
HYALURONIDASE
INJECTABLE;INJECTION
HYDASE
AKORN INC
VITRASE
150 UNITS/ML N021716 001 Oct 25, 2005
BAUSCH AND LOMB
WYDASE
6,200 UNITS/VIAL N021640 001 May 05, 2004
BAXTER HLTHCARE 150 UNITS/ML
150 UNITS/VIAL **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
1,500 UNITS/VIAL **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
N006343 002
N006343 006
N006343 005
HYDRALAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
APRESOLINE
NOVARTIS
HYDRALAZINE HYDROCHLORIDE
20MG/ML N008303 003
ABRAXIS PHARM
SMITH AND NEPHEW
SOLOPAK
TEVA PARENTERAL
TABLET;ORAL
APRESOLINE
20MG/ML
20MG/ML
20MG/ML
20MG/ML
A089532 001
A088518 001
A088517 001
A040373 001
Aug 11, 1987
Apr 20, 1984
Aug 22, 1985
Feb 23, 2000
NOVARTIS 10MG N008303 004
25MG N008303 001
50MG N008303 002
100MG N008303 005
DRALZINE
TEVA 25MG A084301 001
HYDRALAZINE HYDROCHLORIDE
ACTAVIS TOTOWA
ASCOT
HALSEY
IMPAX LABS
25MG
50MG
25MG
50MG
10MG
25MG
50MG
100MG
25MG
A088560 001
A088649 001
A088310 001
A088311 001
A089218 001
A089130 001
A089222 001
A089178 001
A084922 001
Oct 04, 1984
Oct 18, 1984
Dec 19, 1984
Dec 19, 1984
Jan 22, 1986
Jan 15, 1986
Jan 22, 1986
Jan 15, 1986
50MG A084923 001
IVAX SUB TEVA PHARMS 10MG A084443 001
25MG A084437 001
50MG A084469 002
100MG A084581 001
MUTUAL PHARM 10MG
10MG
A088728 001
A089359 001
Apr 11, 1985
Jul 25, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-156( of 322)
HYDRALAZINE HYDROCHLORIDE
TABLET;ORAL
HYDRALAZINE HYDROCHLORIDE
25MG A084106 002
25MG A089258 001 May 05, 1986
50MG A084107 002
50MG A089259 001 May 05, 1986
100MG A088729 001 Apr 11, 1985
PUREPAC PHARM 25MG A088177 001 Jul 29, 1983
50MG A088178 001 Aug 15, 1983
QUANTUM PHARMICS 10MG A088671 001 May 01, 1984
25MG A088657 001 Jun 15, 1984
50MG A088652 001 May 08, 1984
100MG A088686 001 May 01, 1984
SANDOZ 10MG A083241 001
25MG A083560 001
50MG A083561 001
50MG A085088 001
SUPERPHARM 10MG A088787 001 Aug 28, 1984
25MG A088788 001 Aug 28, 1984
50MG A088789 001 Aug 28, 1984
TG UNITED LABS 10MG A088846 001 Feb 26, 1985
25MG A088847 001 Feb 26, 1985
50MG A088848 001 Feb 26, 1985
100MG A088849 001 Feb 26, 1985
USL PHARMA 25MG A087780 001 Mar 29, 1982
50MG A087751 001 Mar 29, 1982
VANGARD 25MG A087712 001
50MG A087908 001 May 07, 1982
VITARINE 25MG A086088 001
WATSON LABS 25MG A085532 002 May 24, 1982
50MG A085533 002 May 25, 1982
WEST WARD 25MG A088240 001 May 27, 1983
50MG A088241 001 May 27, 1983
ZYDUS PHARMS USA 10MG A040858 001 Feb 26, 2010
25MG A040858 002 Feb 26, 2010
50MG A040858 003 Feb 26, 2010
100MG A040858 004 Feb 26, 2010
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
CAPSULE;ORAL
APRESAZIDE
NOVARTIS 25MG;25MG A084735 001
50MG;50MG A084810 001
100MG;50MG A084811 001
HYDRA-ZIDE
PAR PHARM 100MG;50MG A088961 001 Oct 21, 1985
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
SOLVAY 25MG;25MG A087608 001 Feb 08, 1982
50MG;50MG A087213 001 Feb 08, 1982
100MG;50MG A087609 001 Feb 08, 1982
SUPERPHARM 25MG;25MG A089200 001 Feb 09, 1987
50MG;50MG A089201 001 Feb 09, 1987
WATSON LABS 25MG;25MG A085457 001 Mar 04, 1982
50MG;50MG A085446 001 Mar 04, 1982
100MG;50MG A085440 001 Mar 04, 1982
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50
IVAX PHARMS 100MG;50MG A088358 001 Apr 10, 1984
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25
IVAX PHARMS 25MG;25MG A088356 001 Apr 10, 1984
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50
IVAX PHARMS 50MG;50MG A088357 001 Apr 10, 1984
TABLET;ORAL
APRESOLINE-ESIDRIX
NOVARTIS 25MG;15MG N012026 002
HYDRALAZINE AND HYDROCHLORTHIAZIDE
WATSON LABS 25MG;15MG A085827 001
HYDROCHLOROTHIAZIDE W/ HYDRALAZINE
WATSON LABS 25MG;15MG A085373 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
TABLET;ORAL
CAM-AP-ES
TG UNITED LABS 25MG;15MG;0.1MG
HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE
IVAX SUB TEVA PHARMS 25MG;15MG;0.1MG
HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE
MYLAN 25MG;15MG;0.1MG
HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE
WATSON LABS 25MG;15MG;0.1MG
HYDRAP-ES
SANDOZ 25MG;15MG;0.1MG
HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE
WATSON LABS 25MG;15MG;0.1MG
HYDROSERPINE PLUS (R-H-H)
IVAX SUB TEVA PHARMS 25MG;15MG;0.1MG
RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
MUTUAL PHARM 25MG;15MG;0.1MG
SOLVAY 25MG;15MG;0.1MG
WATSON LABS 25MG;15MG;0.1MG
25MG;15MG;0.1MG
RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE
LEDERLE 25MG;15MG;0.1MG
SER-A-GEN
SOLVAY 25MG;15MG;0.1MG
SER-AP-ES
NOVARTIS 25MG;15MG;0.1MG
UNIPRES
SOLVAY 25MG;15MG;0.1MG
25MG;15MG;0.1MG
HYDRALAZINE HYDROCHLORIDE; RESERPINE
6-157( of 322)
A084897 001
A084291 001
A087085 001
A085771 001
A084876 001
A083770 001
A083877 001
A088570 001 Apr 10, 1984
A088376 001 Oct 28, 1983
A085549 001
A087556 001
A087709 001 May 13, 1982
A087210 001
N012193 005
A085893 001
A086298 001
A084617 001
N009296 004
N009296 002
A077885 001 Nov 26, 2007
A089661 001 Jun 20, 1988
A088587 001 Jul 02, 1984
A088588 001 Jul 02, 1984
N011793 005
N011793 008
N011793 009
A086504 001
A083891 002
A085672 001
A085054 002
A085208 001
A086369 001
A083554 001
A087539 001 Feb 03, 1982
A087540 001 Feb 03, 1982
A084771 001
A087060 001
A085152 002
A084135 001
A084029 001
A083607 002
A085098 001
A084776 001
TABLET;ORAL
DRALSERP
SANDOZ
SERPASIL-APRESOLINE
NOVARTIS
HYDROCHLOROTHIAZIDE
CAPSULE;ORAL
HYDROCHLOROTHIAZIDE
WEST WARD
SOLUTION;ORAL
HYDROCHLOROTHIAZIDE
MORTON GROVE
ROXANE
HYDROCHLOROTHIAZIDE INTENSOL
ROXANE
TABLET;ORAL
ESIDRIX
NOVARTIS
HYDRO-D
HALSEY
HYDROCHLOROTHIAZIDE
ABC HOLDING
ACTAVIS ELIZABETH
ALRA
ASCOT
BARR
DAVA PHARMS INC
ELKINS SINN
HEATHER
IMPAX LABS
INWOOD LABS
25MG;0.1MG
25MG;0.1MG
50MG;0.2MG
12.5MG
50MG/5ML
50MG/5ML
100MG/ML
25MG
50MG
100MG
25MG
50MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
50MG
100MG
50MG
50MG
25MG
50MG
100MG
25MG
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
HYDROCHLOROTHIAZIDE
TABLET;ORAL
HYDROCHLOROTHIAZIDE
IVAX SUB TEVA PHARMS
MAST MM
MUTUAL PHARM
MYLAN
PVT FORM
ROXANE
SANDOZ
SOLVAY
SUPERPHARM
TEVA
TG UNITED LABS
USL PHARMA
VANGARD
WARNER CHILCOTT
WATSON LABS
WEST WARD
WHITEWORTH TOWN PLSN
HYDRODIURIL
MERCK
ORETIC
ABBVIE
ZIDE
SOLVAY
HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET;ORAL
AVALIDE
SANOFI AVENTIS US
25MG
50MG
50MG
100MG
25MG
50MG
25MG
50MG
100MG
25MG
50MG
50MG
25MG
50MG
50MG
25MG
25MG
50MG
50MG
25MG
25MG
50MG
100MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG
50MG
100MG
100MG
100MG
25MG
25MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
12.5MG;75MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
25MG;300MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
6-158( of 322)
A085067 001
A084776 002
A084658 001
A085022 001
A086192 001
A086192 002
A083972 001
A083972 002
A083972 003
A084880 001
A085112 001
A086597 001
A085004 001
A084536 002
A085005 001
A083899 001
A087565 001
A084912 001
A085219 001
A085323 001
A088827 001
A088828 001
A088829 001
A088924 001
A088923 001
A085683 001
A083965 001
A087827 001
A087752 001
A087638 001
A087610 001
A087586 001
A087587 001
A081189 001
A083458 001
A085232 002
A083232 001
A083456 001
A085233 001
A086087 001
A086594 001
A081190 001
A085099 001
A087002 001
A084878 002
A084899 001
A083809 002
A083809 001
A085347 001
N011835 003
N011835 006
N011835 007
N011971 001
A083925 001
Mar 09, 1982
Dec 28, 1984
Dec 28, 1984
Dec 28, 1984
Feb 07, 1985
Feb 07, 1985
Apr 19, 1982
Apr 19, 1982
May 03, 1982
May 03, 1982
Jan 24, 1992
Jan 24, 1992
Jul 12, 2006
N020758 001 Sep 30, 1997
N020758 004 Mar 15, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-159( of 322)
HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET;ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDE
TEVA 25MG;300MG A077369 003 Mar 30, 2012
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
TABLET;ORAL
NORMOZIDE
SCHERING 25MG;100MG N019046 001 Apr 06, 1987
25MG;200MG N019046 002 Apr 06, 1987
25MG;300MG N019046 003 Apr 06, 1987
25MG;400MG N019046 004 Apr 06, 1987
TRANDATE HCT
GLAXOSMITHKLINE 25MG;100MG N019174 001 Apr 10, 1987
25MG;200MG N019174 002 Apr 10, 1987
25MG;300MG N019174 003 Apr 10, 1987
25MG;400MG N019174 004 Apr 10, 1987
HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET;ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
SANDOZ 12.5MG;10MG A075926 001 Jul 01, 2002
12.5MG;20MG A075926 002 Jul 01, 2002
25MG;20MG A075926 003 Jul 01, 2002
TEVA 12.5MG;10MG A075869 001 Jul 01, 2002
12.5MG;20MG A075869 002 Jul 01, 2002
25MG;20MG A075869 003 Jul 01, 2002
PRINZIDE
MERCK 25MG;20MG N019778 002 Feb 16, 1989
HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET;ORAL
ALDORIL 15
MERCK 15MG;250MG N013402 001
ALDORIL 25
MERCK 25MG;250MG N013402 002
ALDORIL D30
MERCK 30MG;500MG N013402 003
ALDORIL D50
MERCK 50MG;500MG N013402 004
METHYLDOPA AND HYDROCHLOROTHIAZIDE
CLONMEL HLTHCARE 15MG;250MG A072507 001 Jun 02, 1989
25MG;250MG A072508 001 Jun 02, 1989
30MG;500MG A072509 001 Jun 02, 1989
50MG;500MG A072510 001 Jun 02, 1989
IVAX SUB TEVA PHARMS 15MG;250MG A071458 001 Mar 08, 1988
25MG;250MG A071459 001 Mar 08, 1988
30MG;500MG A071460 001 Mar 08, 1988
50MG;500MG A071461 001 Mar 08, 1988
PAR PHARM 15MG;250MG A070616 001 Feb 02, 1987
25MG;250MG A070612 001 Feb 02, 1987
30MG;500MG A070613 001 Feb 02, 1987
50MG;500MG A070614 001 Feb 02, 1987
PARKE DAVIS 15MG;250MG A071897 001 Nov 23, 1987
25MG;250MG A071898 001 Nov 23, 1987
30MG;500MG A071899 001 Nov 23, 1987
50MG;500MG A071900 001 Nov 23, 1987
PUREPAC PHARM 15MG;250MG A070853 001 Oct 08, 1986
25MG;250MG A070688 001 Apr 24, 1986
30MG;500MG A070854 001 Oct 08, 1986
50MG;500MG A070689 001 Apr 24, 1986
SANDOZ 15MG;250MG A070182 001 Jan 15, 1986
15MG;250MG A070829 001 Mar 09, 1987
25MG;250MG A070183 001 Jan 15, 1986
25MG;250MG A070830 001 Mar 09, 1987
30MG;500MG A070543 001 Jan 15, 1986
50MG;500MG A070544 001 Jan 15, 1986
TEVA 15MG;250MG A071819 001 Apr 08, 1988
25MG;250MG A071820 001 Apr 08, 1988
30MG;500MG A071821 001 Apr 08, 1988
50MG;500MG A071822 001 Apr 08, 1988
WATSON LABS 15MG;250MG A070365 001 Mar 19, 1986
15MG;250MG A070958 001 Feb 06, 1989
15MG;250MG A071920 001 Aug 29, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-160( of 322)
HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET;ORAL
METHYLDOPA AND HYDROCHLOROTHIAZIDE
25MG;250MG A070366 001 Apr 16, 1986
25MG;250MG A070959 001 Jan 19, 1989
25MG;250MG A071921 001 Aug 29, 1988
30MG;500MG A070367 001 Mar 19, 1986
30MG;500MG A071069 001 Jan 19, 1989
30MG;500MG A071922 001 Aug 29, 1988
50MG;500MG A070368 001 Apr 16, 1986
50MG;500MG A070960 001 Feb 06, 1989
50MG;500MG A071923 001 Aug 29, 1988
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
TABLET;ORAL
LOPRESSOR HCT
US PHARMS HOLDINGS I 50MG;100MG N018303 003 Dec 31, 1984
HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
TABLET;ORAL
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
PADDOCK LLC 12.5MG;7.5MG A090096 001 Sep 25, 2008
12.5MG;15MG A090096 002 Sep 25, 2008
25MG;15MG A090096 003 Sep 25, 2008
HYDROCHLOROTHIAZIDE; PINDOLOL
TABLET;ORAL
VISKAZIDE
NOVARTIS 25MG;5MG N018872 001 Jul 22, 1987
25MG;10MG N018872 002 Jul 22, 1987
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
INDERIDE LA 120/50
WYETH AYERST 50MG;120MG N019059 002 Jul 03, 1985
INDERIDE LA 160/50
WYETH AYERST 50MG;160MG N019059 003 Jul 03, 1985
INDERIDE LA 80/50
WYETH AYERST 50MG;80MG N019059 001 Jul 03, 1985
TABLET;ORAL
INDERIDE-80/25
WYETH PHARMS INC 25MG;80MG N018031 002
PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE
DURAMED PHARMS BARR 25MG;40MG A071126 001 Mar 02, 1987
25MG;80MG A071127 001 Mar 02, 1987
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ACTAVIS ELIZABETH 25MG;40MG A070851 001 May 15, 1986
25MG;80MG A070852 001 May 15, 1986
BARR 25MG;40MG A070704 001 Oct 01, 1986
25MG;80MG A070705 001 Oct 01, 1986
IVAX SUB TEVA PHARMS 25MG;40MG A071552 001 Dec 01, 1988
25MG;80MG A071553 001 Dec 01, 1988
SANDOZ 25MG;40MG A071060 001 Aug 26, 1987
25MG;80MG A071061 001 Aug 26, 1987
WARNER CHILCOTT 25MG;40MG A071771 001 Jan 26, 1988
25MG;80MG A071772 001 Jan 26, 1988
WATSON LABS 25MG;40MG A070301 001 Apr 18, 1986
25MG;40MG A071498 001 Dec 18, 1991
25MG;80MG A070305 001 Apr 18, 1986
25MG;80MG A071501 001 Dec 18, 1991
HYDROCHLOROTHIAZIDE; RESERPINE
TABLET;ORAL
H.R.-50
WHITEWORTH TOWN PLSN 50MG;0.125MG A085338 001
HYDRO-RESERP
ABC HOLDING 50MG;0.125MG A084714 002 Jun 29, 1982
HYDRO-SERP "25"
SANDOZ 25MG;0.125MG A084827 001
HYDRO-SERP "50"
SANDOZ 50MG;0.125MG A085213 001
HYDROCHLOROTHIAZIDE W/ RESERPINE
IVAX SUB TEVA PHARMS 25MG;0.1MG A083572 001
25MG;0.125MG A083571 001
50MG;0.1MG A083568 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
HYDROCHLOROTHIAZIDE; RESERPINE
TABLET;ORAL
HYDROCHLOROTHIAZIDE W/ RESERPINE
50MG;0.125MG
PHARMERAL 25MG;0.125MG
50MG;0.125MG
ROXANE 50MG;0.125MG
WATSON LABS 25MG;0.125MG
25MG;0.125MG
25MG;0.125MG
50MG;0.125MG
50MG;0.125MG
50MG;0.125MG
HYDROPRES 25
MERCK 25MG;0.125MG
HYDROPRES 50
MERCK 50MG;0.125MG
RESERPINE AND HYDROCHLOROTHIAZIDE
BARR 25MG;0.125MG
50MG;0.125MG
SANDOZ 50MG;0.125MG
RESERPINE AND HYDROCHLOROTHIAZIDE-50
WEST WARD 50MG;0.125MG
SERPASIL-ESIDRIX #1
NOVARTIS 25MG;0.1MG
SERPASIL-ESIDRIX #2
NOVARTIS 50MG;0.1MG
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
TABLET;ORAL
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ASCOT 25MG;25MG
MUTUAL PHARM 25MG;25MG
PUREPAC PHARM 25MG;25MG
SANDOZ 25MG;25MG
SUPERPHARM 25MG;25MG
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
IVAX PHARMS
LEDERLE
PARKE DAVIS
PUREPAC PHARM
UPSHER SMITH
USL PHARMA
VANGARD
WATSON LABS
25MG;25MG
25MG;25MG
25MG;25MG
25MG;25MG
25MG;25MG
25MG;25MG
25MG;25MG
25MG;25MG
25MG;25MG
HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE
TABLET;ORAL
TIMOLIDE 10-25
MERCK 25MG;10MG
HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE;ORAL
DYAZIDE
GLAXOSMITHKLINE LLC 25MG;50MG
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
BARR 25MG;37.5MG
NOVARTIS 25MG;37.5MG
VITARINE 25MG;50MG
TABLET;ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
AM THERAP 50MG;75MG
QUANTUM PHARMICS 50MG;75MG
WATSON LABS 50MG;75MG
HYDROCODONE BITARTRATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
SYRUP;ORAL
CODAMINE
ALPHARMA US PHARMS
HYCOMINE
ENDO PHARMS
HYCOMINE PEDIATRIC
ENDO PHARMS
5MG/5ML;25MG/5ML
5MG/5ML;25MG/5ML
2.5MG/5ML;12.5MG/5ML
6-161( of 322)
A083573 001
A085421 001
A085420 001
A084603 001
A084466 001
A085317 001
A086330 002
A083666 001
A084467 001
A086331 001
N011958 002
N011958 003
A084580 001
A084579 001
A088200 001 Jan 31, 1984
A088189 001 May 10, 1984
N011878 003
N011878 005
A088025 001 Nov 23, 1984
A087267 001
A087999 001 Nov 06, 1985
A086881 001
A089137 001 Aug 26, 1985
A087004 002 May 24, 1982
A087511 001
A087948 001 Feb 22, 1983
A088054 001 Aug 18, 1983
A087553 001
A087651 001
A087655 001
A085974 001
A086026 001
N018061 001
N016042 002
A074970 001 Jan 06, 1998
A074857 001 Sep 09, 1997
A071737 001 Feb 12, 1988
A072022 001 Apr 17, 1988
A071980 001 Apr 17, 1988
A071969 001 Apr 17, 1988
A075103 001 Sep 29, 2000
N019410 001 Aug 17, 1990
N019411 001 Aug 17, 1990
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-162( of 322)
HYDROCORTAMATE HYDROCHLORIDE
OINTMENT;TOPICAL
MAGNACORT
PFIZER
HYDROCORTISONE
AEROSOL;TOPICAL
AEROSEB-HC
ALLERGAN HERBERT
CREAM;TOPICAL
CORT-DOME
BAYER PHARMS
DERMACORT
MONARCH PHARMS
ELDECORT
VALEANT PHARM INTL
FLEXICORT
WESTWOOD SQUIBB
H-CORT
PHARM ASSOC
HC #1
BAYER PHARMS
HC #4
BAYER PHARMS
HC (HYDROCORTISONE)
C AND M PHARMA
HI-COR
C AND M PHARMA
HYDROCORTISONE
ALPHARMA US PHARMS
ALTANA
AMBIX
EVERYLIFE
G AND W LABS
INGRAM PHARM
IVAX PHARMS
NASKA
PERRIGO NEW YORK
PHARMADERM
PHARMAFAIR
STIEFEL
SYOSSET
TARO
TEVA
TOPIDERM
USL PHARMA
WHITEWORTH TOWN PLSN
HYTONE
VALEANT INTL
NOGENIC HC
IVAX PHARMS
NUTRACORT
DOW PHARM
PENECORT
ALLERGAN HERBERT
0.5%
0.5%
0.5%
1%
1%
1%
2.5%
0.5%
1%
2.5%
0.5%
0.5%
1%
0.5%
1%
2.5%
2.5%
0.5%
1%
1%
2.5%
0.5%
1%
1%
0.5%
1%
1%
1%
0.5%
1%
1%
2.5%
1%
1%
0.5%
0.5%
0.5%
1%
1%
2.5%
1%
1%
2.5%
1%
1%
2.5%
1%
0.5%
1%
1%
N010554 001
A085805 001
N009585 003
N009585 001
A083011 002
A080459 001
A084055 001
A087136 003 Apr 08, 1982
A087136 002 Apr 08, 1982
A087136 001 Apr 08, 1982
A086823 001
A080438 001
A080438 002
A080482 003
A080482 004
A080483 001
A089754 001 Feb 01, 1989
A080848 002
A080848 003
A086080 001
A086271 001
A080452 001
A080452 002
A084059 001
A080456 002
A080456 003
A085733 001
A089706 001 Mar 10, 1988
A084970 002
A085026 001
A088845 001 Feb 27, 1986
A089413 001 Dec 16, 1986
A087838 001 Jul 28, 1982
A086170 001
A085527 001
A086154 001
A080400 002
A080400 003
A085191 001
A080400 004
A089273 001 Feb 17, 1989
A088027 001 Sep 27, 1983
A088029 001 Sep 27, 1983
A080496 002
A080472 003
A080472 004
A087427 001 Apr 04, 1988
A080442 002
A080442 003
A088216 001 Jun 06, 1984
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
HYDROCORTISONE
CREAM;TOPICAL
PROCTOCORT
MONARCH PHARMS 1%
SYNACORT
MEDICIS 0.5%
GEL;TOPICAL
NUTRACORT
HEALTHPOINT 1%
PENECORT
ALLERGAN HERBERT 1%
INJECTABLE;INJECTION
CORTEF
PHARMACIA AND UPJOHN 50MG/ML
LOTION;TOPICAL
ACTICORT
BAKER NORTON 1%
BALNEOL-HC
SOLVAY 1%
BETA-HC
BETA DERMAC 1%
CETACORT
DOW PHARM 0.5%
1%
CORT-DOME
BAYER PHARMS 0.5%
1%
DERMACORT
SOLVAY 0.5%
1%
EPICORT
BLULINE 0.5%
GLYCORT
HERAN 1%
H-CORT
PHARM ASSOC 0.5%
HYDROCORTISONE
ALPHARMA US PHARMS 0.5%
1%
MERICON 0.5%
1%
NASKA 1%
PERRIGO NEW YORK 0.5%
1%
TARO 1%
HYTONE
VALEANT INTL 1%
2.5%
NUTRACORT
DOW PHARM 0.5%
STIE-CORT
PERRIGO CO 1%
OINTMENT;TOPICAL
CORTRIL
PFIZER GLOBAL 1%
2.5%
HC (HYDROCORTISONE)
C AND M PHARMA 0.5%
1%
HYDROCORTISONE
ALTANA 0.5%
1%
AMBIX 1%
2.5%
NASKA 1%
PERRIGO NEW YORK 0.5%
1%
PHARMADERM 1%
TARO 0.5%
2.5%
USL PHARMA 1%
2.5%
6-163( of 322)
A083011 001
A087459 001
A084698 001
A088215 001 Jun 06, 1984
N009864 001
A086535 001
A088041 001 Dec 03, 1982
A089495 001 Jan 25, 1988
A080426 002
A080426 001
N009895 003
N009895 001
A084573 002
A086462 001
A083219 002
A087489 001 Oct 03, 1983
A086824 001
A087317 001 Jun 07, 1982
A087315 001 Jun 07, 1982
A085282 001
A085282 002 Feb 26, 1987
A089705 001 Apr 25, 1988
A085662 001
A085663 001
A089024 001 Feb 12, 1986
A080473 003
A080473 004 Nov 30, 1982
A080443 002
A089066 001 Nov 25, 1985
N009176 001
N009176 002
A080481 001
A080481 002
A080489 002
A080489 003
A086079 001
A086272 001
A089704 001 Mar 10, 1988
A084969 003
A085028 001
A088842 001 Feb 09, 1987
A086256 001
A040310 001 Dec 29, 2000
A088061 001 Sep 27, 1983
A088039 001 Sep 27, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-164( of 322)
A080474 003
A080474 004
A088217 001 Jun 06, 1984
A087834 001 Mar 29, 1982
A088082 001 Apr 08, 1983
A088214 001 Jun 06, 1984
A080425 001
N009127 005
N009127 003
A083999 001
A080624 001
A080568 001
A080568 002
A080781 001
A080732 001
A085070 001
A083140 001
N009659 001
N009659 002
A084243 001
A084247 003 Aug 31, 1982
A080395 001
A084247 002
A088539 001 Mar 21, 1984
A080642 002
A080355 001
A083365 001
A080344 001
A080344 002
N008506 007
N008506 011
N009796 001
A081274 001 Jun 19, 1992
A080419 001 Jan 25, 1982
A089914 001 Jan 03, 1989
A086050 001
A086052 001
N009378 002
N009164 001
N009637 001
N009637 002
A083739 001
A083739 002
A083128 001
A083759 001
A083759 002
A085214 001
HYDROCORTISONE
OINTMENT;TOPICAL
HYTONE
DERMIK LABS
PENECORT
ALLERGAN HERBERT
POWDER;FOR RX COMPOUNDING
H-CORT
TORCH
HYDROCORTISONE
PADDOCK LLC
SOLUTION;TOPICAL
PENECORT
ALLERGAN HERBERT
TEXACORT
MISSION PHARMA
TABLET;ORAL
CORTRIL
PFIZER
HYDROCORTISONE
BARR
ELKINS SINN
FERRANTE
IMPAX LABS
INWOOD LABS
LANNETT
NEXGEN PHARMA INC
PANRAY
PARKE DAVIS
PUREPAC PHARM
ROXANE
SANDOZ
WATSON LABS
WEST WARD
WHITEWORTH TOWN PLSN
HYDROCORTONE
MERCK
TABLET;VAGINAL
CORTRIL
PFIPHARMECS
HYDROCORTISONE ACETATE
CREAM;TOPICAL
HEMSOL-HC
ABLE
HYDROCORTISONE ACETATE
CENCI
PARKE DAVIS
PUREPAC PHARM
INJECTABLE;INJECTION
CORTEF ACETATE
PHARMACIA AND UPJOHN
CORTRIL
PFIZER
HYDROCORTISONE ACETATE
AKORN
BEL MAR
WATSON LABS
1%
2.5%
2.5%
100%
100%
1%
1%
10MG
20MG
20MG
20MG
10MG
20MG
20MG
20MG
20MG
20MG
10MG
20MG
20MG
10MG
20MG
20MG
10MG
20MG
20MG
20MG
10MG
20MG
10MG
20MG
10MG
1%
1%
1%
0.5%
1%
50MG/ML
25MG/ML
25MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG/ML
25MG/ML
50MG/ML
50MG/ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-165( of 322)
HYDROCORTISONE ACETATE
INJECTABLE;INJECTION
HYDROCORTONE
MERCK 25MG/ML N008228 001
50MG/ML N008228 004
LOTION;TOPICAL
DRICORT
INGRAM PHARM 0.5% A086207 001
OINTMENT;OPHTHALMIC
HYDROCORTISONE ACETATE
FERA PHARMS 0.5% A080828 001
OINTMENT;OPHTHALMIC, OTIC
HYDROCORTONE
MERCK 1.5% N009018 003
OINTMENT;TOPICAL
CORTEF ACETATE
PHARMACIA AND UPJOHN 1% N008917 002
2.5% **Federal Register determination N008917 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PASTE;TOPICAL
ORABASE HCA
COLGATE 0.5% A083205 001
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
CREAM;TOPICAL
NEO-CORTEF
PHARMACIA AND UPJOHN 1%;EQ 3.5MG BASE/GM A061049 001
2.5%;EQ 3.5MG BASE/GM A061049 002
OINTMENT;OPHTHALMIC
NEO-CORTEF
PHARMACIA AND UPJOHN 0.5%;EQ 3.5MG BASE/GM A060610 001
1.5%;EQ 3.5MG BASE/GM A060610 002
OINTMENT;TOPICAL
NEO-CORTEF
PHARMACIA AND UPJOHN 0.5%;EQ 3.5MG BASE/GM A060751 001
1%;EQ 3.5MG BASE/GM A060751 002
2.5%;EQ 3.5MG BASE/GM A060751 003
SUSPENSION/DROPS;OPHTHALMIC
COR-OTICIN
AKORN 1.5%;EQ 3.5MG BASE/ML A060188 001
NEO-CORTEF
PHARMACIA AND UPJOHN 0.5%;EQ 3.5MG BASE/ML A060612 002
1.5%;EQ 3.5MG BASE/ML A060612 001
HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE
SUSPENSION;OPHTHALMIC
TERRA-CORTRIL
PFIZER 1.5%;EQ 5MG BASE/ML A061016 001
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
AEROSOL, METERED;TOPICAL
HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%
BOCA PHARMA LLC 1%;1% A089440 001 May 17, 1988
LOTION;TOPICAL
PRAMOSONE
FERNDALE LABS 0.5%;1% A083213 002
HYDROCORTISONE ACETATE; UREA
CREAM;TOPICAL
CARMOL HC
FOUGERA PHARMS 1%;10% A080505 001
HYDROCORTISONE BUTYRATE
CREAM;TOPICAL
LOCOID
YAMANOUCHI 0.1% N018795 001 Jan 07, 1983
OINTMENT;TOPICAL
LOCOID
YAMANOUCHI 0.1% N019106 001 Jul 03, 1984
SOLUTION;TOPICAL
LOCOID
YAMANOUCHI 0.1% N019819 001 Sep 15, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
HYDROCORTISONE CYPIONATE
SUSPENSION;ORAL
CORTEF
PHARMACIA AND UPJOHN
HYDROCORTISONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
HYDROCORTONE
MERCK
HYDROCORTISONE SODIUM SUCCINATE
INJECTABLE;INJECTION
A-HYDROCORT
ABBOTT
HOSPIRA
HYDROCORTISONE SODIUM SUCCINATE
EQ 10MG BASE/5ML
EQ 50MG BASE/ML
EQ 1GM BASE/VIAL
EQ 100MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
ABRAXIS PHARM
BAXTER HLTHCARE
INTL MEDICATION
WATSON LABS
HYDROCORTISONE VALERATE
CREAM;TOPICAL
HYDROCORTISONE VALERATE
TEVA PHARMS
WESTCORT
RANBAXY
OINTMENT;TOPICAL
HYDROCORTISONE VALERATE
FOUGERA PHARMS
WESTCORT
RANBAXY
EQ 1GM BASE/VIAL
EQ 100MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 100MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
0.2%
0.2%
0.2%
0.2% **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
HYDROCORTISONE; NEOMYCIN SULFATE
CREAM;TOPICAL
NEO-CORT-DOME
BAYER PHARMS 0.5%;EQ 3.5MG BASE/GM
1%;EQ 3.5MG BASE/GM
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SOLUTION/DROPS;OTIC
NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE
NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE
PHARMAFAIR
OTOCORT
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
WATSON LABS
SUSPENSION/DROPS;OPHTHALMIC
CORTISPORIN
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
SUSPENSION/DROPS;OTIC
NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE
PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
N009900 001
N012052 001
A089580 001
A085928 001
A089577 001
A089578 001
A089579 001
A085932 001
A085929 001
A085930 001
A085931 001
A088670 001
A088667 001
A088712 001
A088668 001
A088669 001
A087569 001
A086619 001
A087567 001
A087568 001
A087532 001
A084748 001
A084737 002
A084738 001
A084737 001
A084747 001
A074489 001
N017950 001
A075085 001
N018726 001
N050237 006
N050237 005
A062394 001
A060730 002
N050169 001
A062623 001
A062617 001
6-166( of 322)
Apr 11, 1989
Apr 11, 1989
Apr 11, 1989
Apr 11, 1989
Jun 08, 1984
Jun 08, 1984
Jun 08, 1984
Jun 08, 1984
Jun 08, 1984
Mar 19, 1982
Aug 12, 1998
Jul 31, 2001
Aug 08, 1983
Jun 05, 1984
Jun 05, 1984
Sep 29, 1982
Sep 24, 1985
Sep 18, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SUSPENSION/DROPS;OTIC
OTICAIR
PHARMAFAIR
OTOBIONE
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
SCHERING
OTOCORT
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
WATSON LABS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
HYDROCORTISONE; POLYMYXIN B SULFATE
SOLUTION/DROPS;OTIC
OTOBIOTIC
SCHERING 5MG/ML;EQ 10,000 UNITS BASE/ML
PYOCIDIN
FOREST LABS 5MG/ML;EQ 10,000 UNITS BASE/ML
HYDROCORTISONE; TETRACYCLINE HYDROCHLORIDE
OINTMENT;OPHTHALMIC
ACHROMYCIN
LEDERLE
HYDROCORTISONE; UREA
CREAM;TOPICAL
ALPHADERM
BIOGLAN
CALMURID HC
PHARMACIA AND UPJOHN
HYDROFLUMETHIAZIDE
TABLET;ORAL
DIUCARDIN
WYETH AYERST
HYDROFLUMETHIAZIDE
PAR PHARM
WATSON LABS
HYDROFLUMETHIAZIDE; RESERPINE
TABLET;ORAL
1.5%;1%
1%;10%
1%;10%
50MG
50MG
50MG
50MG
HYDROFLUMETHIAZIDE AND RESERPINE
USL PHARMA 50MG;0.125MG
WATSON LABS 25MG;0.125MG
50MG;0.125MG
RESERPINE AND HYDROFLUMETHIAZIDE
IVAX PHARMS 50MG;0.125MG
PAR PHARM 50MG;0.125MG
SALUTENSIN
SHIRE 50MG;0.125MG
SALUTENSIN-DEMI
SHIRE 25MG;0.125MG
HYDROMORPHONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
PALLADONE
PURDUE PHARMA LP
INJECTABLE;INJECTION
HYDROMORPHONE HYDROCHLORIDE
WATSON LABS
TABLET;ORAL
HYDROMORPHONE HYDROCHLORIDE
NESHER PHARMS
HYDROXOCOBALAMIN
INJECTABLE;INJECTION
ALPHAREDISOL
MERCK
CYANOKIT
MERCK SANTE SAS
HYDROXOCOBALAMIN
ABRAXIS PHARM
WATSON LABS
12MG
16MG
24MG
32MG
10MG/ML
2MG
4MG
8MG
1MG/ML
2.5GM/VIAL (5GM/KIT)
1MG/ML
1MG/ML
6-167( of 322)
A062399 001 Nov 18, 1982
A061816 001
A062521 001 Jul 11, 1985
A062302 001
A061606 001
N050272 001
A086008 001
A083947 001
A083383 001
A088850 001 May 31, 1985
A088031 001 Apr 06, 1983
A088528 001 Aug 15, 1984
A088195 001 Oct 26, 1983
A088127 001 Mar 22, 1983
A088110 001 Mar 22, 1983
A088932 001 Jan 11, 1985
A088907 001 Sep 20, 1985
N012359 003
N012359 004
N021044 001 Sep 24, 2004
N021044 002 Sep 24, 2004
N021044 003 Sep 24, 2004
N021044 004 Sep 24, 2004
A074317 001 Aug 23, 1995
A077311 001 Nov 09, 2005
A077311 002 Nov 09, 2005
A077311 003 Nov 09, 2005
A080778 001
N022041 002 Dec 15, 2006
A084921 001
A085528 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-168( of 322)
HYDROXOCOBALAMIN
INJECTABLE;INJECTION
HYDROXOMIN
BEL MAR 1MG/ML A084629 001
HYDROXYAMPHETAMINE HYDROBROMIDE
SOLUTION/DROPS;OPHTHALMIC
PAREDRINE
PHARMICS 1% N000004 004
HYDROXYCHLOROQUINE SULFATE
TABLET;ORAL
HYDROXYCHLOROQUINE SULFATE
SANDOZ 200MG A040150 001 Jan 27, 1996
HYDROXYPROGESTERONE CAPROATE
INJECTABLE;INJECTION
DELALUTIN
BRISTOL MYERS SQUIBB 125MG/ML **Federal Register N010347 004
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
125MG/ML **Federal Register N016911 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
250MG/ML **Federal Register N010347 002
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
250MG/ML **Federal Register N016911 002
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
HYDROXYPROGESTERONE CAPROATE
AKORN 125MG/ML N018004 001
WATSON LABS 125MG/ML N017439 001
250MG/ML N017439 002
HYDROXYSTILBAMIDINE ISETHIONATE
INJECTABLE;INJECTION
HYDROXYSTILBAMIDINE ISETHIONATE
SANOFI AVENTIS US 225MG/AMP N009166 001
HYDROXYUREA
CAPSULE;ORAL
HYDROXYUREA
BARR 250MG A075143 002 Sep 21, 2000
BARR LABS INC 250MG A075020 002 Jun 26, 2000
500MG A075020 001 Jul 30, 1998
ROXANE 500MG A074476 001 Aug 18, 1995
TABLET;ORAL
HYDROXYUREA
BARR 1GM A075734 001 Aug 29, 2000
HYDROXYZINE HYDROCHLORIDE
INJECTABLE;INJECTION
HYDROXYZINE
BAXTER HLTHCARE 50MG/ML A085551 002
HYDROXYZINE HYDROCHLORIDE
ALTANA 25MG/ML A087273 001 Apr 20, 1982
50MG/ML A087273 002 Apr 20, 1982
BAXTER HLTHCARE 25MG/ML A085551 001
FRESENIUS KABI USA 25MG/ML A088184 001 Mar 31, 1983
50MG/ML A088185 001 Mar 31, 1983
HOSPIRA 25MG/ML A087416 001
50MG/ML A086821 001
50MG/ML A087546 001
PHARMAFAIR 25MG/ML A088862 001 Feb 14, 1986
25MG/ML A089106 001 Feb 14, 1986
50MG/ML A088881 001 Feb 14, 1986
50MG/ML A089107 001 Feb 14, 1986
SMITH AND NEPHEW 25MG/ML A087592 001
SOLOPAK 25MG/ML A086822 001
25MG/ML A087591 001
50MG/ML A087310 001
50MG/ML A087593 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-169( of 322)
HYDROXYZINE HYDROCHLORIDE
INJECTABLE;INJECTION
HYDROXYZINE HYDROCHLORIDE
50MG/ML A087595 001
50MG/ML A087596 001
WATSON LABS 25MG/ML A085778 001
25MG/ML A087274 001
50MG/ML A085779 001
50MG/ML A087274 002
WYETH AYERST 25MG/ML A086258 001
50MG/ML A086258 002
ORGATRAX
ORGANON USA INC 25MG/ML A087014 001
50MG/ML A087014 002
VISTARIL
PFIZER 25MG/ML N011111 001
50MG/ML N011111 002
SYRUP;ORAL
ATARAX
ROERIG 10MG/5ML N010485 001
HYDROXYZINE HYDROCHLORIDE
ALPHARMA US PHARMS 10MG/5ML A088785 001 Feb 03, 1988
KV PHARM 10MG/5ML A087730 001 Jul 01, 1982
STI PHARMA LLC 10MG/5ML A086880 001
TABLET;ORAL
ATARAX
PFIZER 10MG N010392 001
25MG N010392 004
50MG N010392 006
100MG N010392 005
HYDROXYZINE HYDROCHLORIDE
ABLE 10MG A040559 001 Jul 22, 2004
25MG A040562 001 Jul 22, 2004
50MG A040563 001 Jul 22, 2004
ACTAVIS TOTOWA 10MG A089071 001 Jul 22, 1986
25MG A089072 001 Jul 22, 1986
50MG A089073 001 Jul 22, 1986
HALSEY 10MG A089366 001 May 02, 1988
25MG A089117 001 May 02, 1988
50MG A089396 001 May 02, 1988
IVAX PHARMS 10MG A087216 001
25MG A087410 001
50MG A087411 001
KV PHARM 10MG A087819 001 Jun 23, 1982
25MG A087820 001 Jun 23, 1982
50MG A087821 001 Jun 23, 1982
100MG A087822 001 Jun 23, 1982
MIKAH PHARMA 10MG A040600 001 Dec 28, 2004
25MG A040602 001 Dec 28, 2004
50MG A040604 001 Dec 28, 2004
MUTUAL PHARM 10MG A088409 001 Nov 15, 1983
25MG A087857 001 Apr 18, 1983
50MG A087860 001 Apr 18, 1983
100MG A087862 001 Apr 18, 1983
PLIVA 100MG A081054 001 Sep 25, 1995
PUREPAC PHARM 10MG A088120 001 Sep 25, 1984
25MG A088121 001 Sep 25, 1984
50MG A088122 001 Sep 25, 1984
QUANTUM PHARMICS 10MG A088540 001 Oct 22, 1985
25MG A088551 001 Oct 22, 1985
50MG A088529 001 Oct 22, 1985
SANDOZ 10MG A087246 002
10MG A087869 001 Dec 20, 1982
25MG A085247 001
25MG A087870 001 Dec 20, 1982
50MG A087245 001
50MG A087871 001 Dec 20, 1982
SUPERPHARM 10MG A088794 001 Dec 05, 1984
25MG A088795 001 Dec 05, 1984
50MG A088796 001 Dec 05, 1984
USL PHARMA 10MG A089121 001 Mar 20, 1986
25MG A089122 001 Mar 20, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-170( of 322)
HYDROXYZINE HYDROCHLORIDE
TABLET;ORAL
HYDROXYZINE HYDROCHLORIDE
50MG A089123 001 Mar 20, 1986
VINTAGE 10MG A087602 001 Jan 22, 1982
25MG A087603 001 Jan 22, 1982
50MG A087604 001 Jan 22, 1982
WATSON LABS 10MG A086827 001
25MG A086829 001
50MG A086836 001
HYDROXYZINE PAMOATE
CAPSULE;ORAL
HY-PAM "25"
TEVA EQ 25MG HCL A088713 001 Mar 04, 1985
HYDROXYZINE PAMOATE
DURAMED PHARMS BARR EQ 25MG HCL A088593 001 Feb 29, 1984
EQ 50MG HCL A088594 001 Feb 29, 1984
EQ 100MG HCL A088595 001 Feb 29, 1984
IVAX SUB TEVA PHARMS EQ 25MG HCL A087761 001 Mar 05, 1982
EQ 50MG HCL A087760 001 Mar 05, 1982
PAR PHARM EQ 25MG HCL A087656 001 Jun 11, 1982
EQ 25MG HCL A089145 001 Mar 17, 1986
EQ 50MG HCL A087657 001 Jun 11, 1982
EQ 50MG HCL A089146 001 Mar 17, 1986
EQ 100MG HCL A087658 001 Jun 11, 1982
SANDOZ EQ 25MG HCL A081127 001 Jun 28, 1991
EQ 50MG HCL A081128 001 Jun 28, 1991
EQ 100MG HCL A081129 001 Jun 28, 1991
SUPERPHARM EQ 25MG HCL A089031 001 Jan 02, 1987
EQ 50MG HCL A089032 001 Jan 02, 1987
EQ 100MG HCL A089033 001 Jan 02, 1987
VANGARD EQ 25MG HCL A088392 001 Sep 19, 1983
EQ 50MG HCL A088393 001 Sep 19, 1983
WATSON LABS EQ 25MG HCL A086698 001
EQ 25MG HCL A086840 001 Jul 01, 1982
EQ 50MG HCL A086695 001
EQ 50MG HCL A086705 001 Jul 01, 1982
EQ 50MG HCL A087767 001 Aug 16, 1982
EQ 100MG HCL A086697 001
EQ 100MG HCL A086728 001 Oct 05, 1982
EQ 100MG HCL A087790 001 Aug 16, 1982
VISTARIL
PFIZER EQ 100MG HCL N011459 006
SUSPENSION;ORAL
VISTARIL
PFIZER EQ 25MG HCL/5ML N011795 001
IBANDRONATE SODIUM
TABLET;ORAL
BONIVA
HOFFMANN LA ROCHE EQ 2.5MG BASE **Federal Register N021455 001 May 16, 2003
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
IBUPROFEN
CAPSULE;ORAL
MIDOL
BAYER 200MG **Federal Register determination A070626 001 Sep 02, 1987
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
200MG **Federal Register determination A071002 001 Sep 02, 1987
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SOLUTION;INTRAVENOUS
CALDOLOR
CUMBERLAND PHARMS 400MG/4ML (100MG/ML) N022348 001 Jun 11, 2009
SUSPENSION;ORAL
CHILDREN'S ADVIL
WYETH CONS 100MG/5ML N019833 002 Sep 19, 1989
IBU
ABBOTT 100MG/5ML N019784 001 Dec 18, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-171( of 322)
IBUPROFEN
SUSPENSION;ORAL
MOTRIN
MCNEIL CONSUMER 100MG/5ML N019842 001 Sep 19, 1989
SUSPENSION/DROPS;ORAL
MOTRIN
MCNEIL 40MG/ML N020476 001 May 25, 1995
TABLET;ORAL
ACHES-N-PAIN
LEDERLE 200MG A071065 001 May 28, 1987
CAP-PROFEN
IBU
PERRIGO 200MG A072097 001 Dec 08, 1987
BASF 400MG
400MG
A070083 001
N018197 001
Feb 22, 1985
IBU-TAB
600MG
600MG
800MG
A070088 001
A070099 001
A070745 001
Feb 08, 1985
Mar 29, 1985
Jul 23, 1986
ALRA
IBUPRIN
800MG A071965 001 Aug 11, 1988
PLIVA
IBUPROFEN
200MG A071773 001 Jul 16, 1987
ABBOTT
CONTRACT PHARMACAL
HALSEY
IVAX SUB TEVA PHARMS
LEDERLE
LEINER
MCNEIL
MUTUAL PHARM
MYLAN
NORTHSTAR HLTHCARE
OHM LABS
PAR PHARM
PERRIGO
PLIVA
PUREPAC PHARM
600MG
800MG
200MG
200MG
300MG
400MG
600MG
800MG
200MG
200MG
200MG
200MG
200MG
400MG
600MG
800MG
400MG
600MG
300MG
400MG
600MG
200MG
200MG
200MG
400MG
600MG
800MG
200MG
400MG
600MG
800MG
400MG
600MG
800MG
400MG
200MG
300MG
400MG
600MG
800MG
200MG
400MG
600MG
800MG
200MG
200MG
300MG
400MG
600MG
A070556 001
A071264 001
A073691 001
A071027 001
A071028 001
A071029 001
A071030 001
A072137 001
A071144 001
A071154 001
A072040 001
A072901 001
A072903 001
A071145 001
A071146 001
A071769 001
A070629 001
A070630 001
A071266 001
A070081 001
A070476 001
A070493 001
A070908 001
A071462 001
A070079 001
A070080 001
A071448 001
A071870 001
A070045 001
A070057 001
A071999 001
A078132 001
A078132 002
A078132 003
A070818 001
A071575 001
A070328 001
A070329 001
A070330 001
A070986 001
A072098 001
A071666 001
A071667 001
A071668 001
A071122 001
A071664 001
A071123 001
A071124 001
A071125 001
Jun 14, 1985
Jul 25, 1986
Feb 25, 1994
Sep 29, 1987
Mar 23, 1987
Mar 23, 1987
Mar 23, 1987
Feb 05, 1988
Jan 20, 1987
Oct 27, 1987
Apr 29, 1988
Dec 19, 1991
Dec 19, 1991
Sep 23, 1986
Sep 23, 1986
May 08, 1987
Sep 19, 1986
Sep 19, 1986
Oct 15, 1986
Jun 16, 1986
Jun 16, 1986
Dec 24, 1985
Sep 26, 1986
Oct 02, 1986
Jul 24, 1985
Jul 24, 1985
Feb 18, 1987
May 05, 1988
Sep 24, 1985
Sep 24, 1985
Dec 03, 1987
Sep 10, 2007
Sep 10, 2007
Sep 10, 2007
Dec 26, 1985
May 08, 1987
Aug 06, 1985
Aug 06, 1985
Aug 06, 1985
Jul 25, 1986
Dec 08, 1987
Jun 18, 1987
Jun 18, 1987
Jun 18, 1987
Oct 03, 1986
Feb 03, 1987
Sep 19, 1986
Sep 19, 1986
Sep 19, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
IBUPROFEN
TABLET;ORAL
IBUPROFEN
800MG
SANDOZ 200MG
200MG
200MG
200MG
300MG
400MG
400MG
600MG
600MG
800MG
800MG
SUPERPHARM 600MG
TEVA 200MG
400MG
600MG
800MG
VINTAGE PHARMS 200MG
WATSON LABS 200MG
200MG
300MG
400MG
600MG
800MG
800MG
IBUPROHM
OHM LABS 400MG
MEDIPREN
MCNEIL 200MG
200MG
MIDOL
BAYER 200MG
200MG
MOTRIN
MCNEIL CONSUMER 300MG
400MG
600MG
800MG
MCNEIL PED 100MG
NUPRIN
BRISTOL MYERS 200MG
200MG
MCNEIL 200MG
200MG
RUFEN
BASF 600MG
TABLET, CHEWABLE;ORAL
MOTRIN
MCNEIL PED 50MG
100MG
IBUPROFEN; OXYCODONE HYDROCHLORIDE
TABLET;ORAL
COMBUNOX
FOREST LABS 400MG;5MG
IDARUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
IDAMYCIN
PHARMACIA AND UPJOHN 5MG/VIAL
10MG/VIAL
20MG/VIAL
IDARUBICIN HYDROCHLORIDE
TEVA PARENTERAL 5MG/VIAL
10MG/VIAL
20MG/VIAL
6-172( of 322)
A071964 001 Feb 01, 1988
A070733 001 Sep 19, 1986
A071807 001 Feb 25, 1988
A074525 001 Dec 15, 1995
A074533 001 Dec 15, 1995
A070734 001 Jun 12, 1986
A070735 001 Jun 12, 1986
A072064 001 Jan 14, 1988
A070736 001 Jun 12, 1986
A072065 001 Jan 14, 1988
A071938 001 Jan 14, 1988
A072169 001 Dec 11, 1987
A070709 001 Apr 25, 1986
A073141 001 May 29, 1992
A073343 001 Jun 30, 1992
A073344 001 Jun 30, 1992
A073345 001 Jun 30, 1992
A072249 001 Jan 10, 1989
A071765 001 Sep 04, 1987
A071905 001 Mar 08, 1988
A071338 001 Dec 01, 1986
A070038 001 Sep 06, 1985
A070041 001 Sep 06, 1985
A071547 001 Jul 02, 1987
A071911 001 Oct 13, 1987
A070469 001 Aug 29, 1985
A070475 001 Feb 06, 1986
A071215 001 Jun 26, 1986
A070591 001 Sep 02, 1987
A071001 001 Sep 02, 1987
N017463 003
N017463 002
N017463 004
N017463 005 May 22, 1985
N020418 001 Nov 16, 1994
A072035 001 Feb 16, 1988
A072036 001 Feb 16, 1988
N019012 001 May 18, 1984
N019012 002 Jul 29, 1987
N018197 002 Mar 05, 1984
N020135 001 Nov 16, 1994
N020135 002 Nov 16, 1994
N021378 001 Nov 26, 2004
N050661 002 Sep 27, 1990
N050661 001 Sep 27, 1990
N050661 003 Apr 25, 1995
A065037 003 May 01, 2002
A065037 002 May 01, 2002
A065037 001 May 01, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
IDOXURIDINE
OINTMENT;OPHTHALMIC
STOXIL
GLAXOSMITHKLINE
SOLUTION/DROPS;OPHTHALMIC
STOXIL
GLAXOSMITHKLINE
IFOSFAMIDE; MESNA
INJECTABLE;INJECTION
IFEX/MESNEX KIT
BAXTER HLTHCARE
ILOPROST
SOLUTION;INHALATION
VENTAVIS
ACTELION PHARMS LTD
IMATINIB MESYLATE
CAPSULE;ORAL
GLEEVEC
NOVARTIS
IMIPRAMINE HYDROCHLORIDE
CONCENTRATE;ORAL
IMIPRAMINE HYDROCHLORIDE
NOVARTIS
INJECTABLE;INJECTION
TOFRANIL
NOVARTIS
TABLET;ORAL
IMIPRAMINE HYDROCHLORIDE
LEDERLE
PAR PHARM
PROSAM LABS
ROXANE
SANDOZ
TEVA
USL PHARMA
VANGARD
WATSON LABS
WEST WARD
JANIMINE
ABBOTT
PRAMINE
ALRA
PRESAMINE
SANOFI AVENTIS US
0.5%
0.1%
1GM/VIAL;100MG/ML
3GM/VIAL;100MG/ML
20MCG/2ML (10MCG/ML)
EQ 50MG BASE
EQ 100MG BASE
25MG/ML
12.5MG/ML
10MG
25MG
50MG
25MG
10MG
25MG
50MG
10MG
25MG
50MG
10MG
25MG
50MG
10MG
25MG
50MG
25MG
10MG
25MG
50MG
10MG
10MG
25MG
25MG
50MG
50MG
25MG
50MG
10MG
25MG
50MG
10MG
25MG
50MG
10MG
25MG
50MG
6-173( of 322)
N015868 001
N013934 001
N019763 003 Oct 10, 1992
N019763 004 Oct 10, 1992
N021779 001 Dec 29, 2004
N021335 001 May 10, 2001
N021335 002 May 10, 2001
A086765 001
N011838 002
A086269 001
A086267 001
A086268 001
A089497 001 Jul 14, 1987
A040753 001 Feb 28, 2008
A040752 001 Feb 28, 2008
A040751 001 Feb 28, 2008
A083799 001
A083799 002
A083799 003
A085200 001
A084869 002
A085133 001
A083729 001
A083729 004
A083729 003
A087776 001 Feb 10, 1982
A088036 001 Nov 03, 1982
A087619 001 Feb 09, 1982
A087631 001 Jan 04, 1982
A085220 001
A085875 001
A084252 002
A085878 001
A085221 001
A085877 001
A088222 001 May 26, 1983
A088223 001 May 26, 1983
N017895 001
N017895 002
N017895 003
A083827 001
A083827 002
A083827 003
N011836 006
N011836 003
N011836 007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-174( of 322)
INAMRINONE LACTATE
INJECTABLE;INJECTION
AMRINONE LACTATE
BAXTER HLTHCARE CORP EQ 5MG BASE/ML A075542 001 May 10, 2000
HOSPIRA EQ 5MG BASE/ML A074616 001 Aug 03, 1998
INOCOR
SANOFI AVENTIS US EQ 5MG BASE/ML N018700 001 Jul 31, 1984
INDAPAMIDE
TABLET;ORAL
INDAPAMIDE
CADISTA PHARMS 1.25MG A075201 001 Dec 04, 1998
2.5MG A075201 002 Dec 04, 1998
SANDOZ 1.25MG A074594 001 May 23, 1996
2.5MG A074594 002 May 23, 1996
TEVA 1.25MG A074498 002 Feb 12, 1998
1.25MG A074665 001 Apr 04, 1997
2.5MG A074498 001 Oct 31, 1996
2.5MG A074665 002 Apr 04, 1997
LOZOL
SANOFI AVENTIS US 1.25MG N018538 002 Apr 29, 1993
2.5MG N018538 001 Jul 06, 1983
INDECAINIDE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
DECABID
LILLY EQ 50MG BASE N019693 001 Dec 29, 1989
EQ 75MG BASE N019693 002 Dec 29, 1989
EQ 100MG BASE N019693 003 Dec 29, 1989
INDINAVIR SULFATE
CAPSULE;ORAL
CRIXIVAN
MERCK SHARP DOHME EQ 100MG BASE N020685 006 Apr 19, 2000
EQ 333MG BASE N020685 005 Dec 17, 1998
INDOCYANINE GREEN
INJECTABLE;INJECTION
IC-GREEN
AKORN 10MG/VIAL N011525 003
40MG/VIAL N011525 004
50MG/VIAL N011525 002
INDOMETHACIN
CAPSULE;ORAL
INDO-LEMMON
TEVA 25MG A070266 001 Nov 07, 1985
50MG A070267 001 Nov 07, 1985
INDOCIN
ICEUTICA OPERATIONS 25MG N016059 001
50MG N016059 002
INDOMETHACIN
ABLE 25MG A076666 001 Dec 17, 2003
50MG A076666 002 Dec 17, 2003
DURAMED PHARMS BARR 25MG A070326 001 Oct 18, 1985
50MG A070327 001 Oct 18, 1985
HALSEY 25MG A070782 001 Jun 03, 1987
50MG A070635 001 Jun 03, 1987
IVAX SUB TEVA PHARMS 25MG N018730 001 May 04, 1984
50MG N018730 002 May 04, 1984
MUTUAL PHARM 25MG A070067 001 Oct 03, 1986
25MG A070899 001 Feb 09, 1987
50MG A070068 001 Oct 03, 1986
50MG A070900 001 Feb 09, 1987
MYLAN 50MG N018858 002 Apr 20, 1984
PARKE DAVIS 25MG N018806 001 Nov 23, 1984
50MG N018806 002 Nov 23, 1984
PIONEER PHARMS 25MG A070813 001 Aug 11, 1986
50MG A070592 001 Aug 11, 1986
PLIVA 25MG A071148 001 Mar 18, 1987
50MG A071149 001 Mar 18, 1987
ROXANE 25MG A070353 001 Jun 18, 1985
50MG A070354 001 Jun 18, 1985
SUPERPHARM 25MG A070487 001 Oct 10, 1986
50MG A070488 001 Oct 10, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-175( of 322)
INDOMETHACIN
CAPSULE;ORAL
INDOMETHACIN
TEVA 25MG A071342 001 Apr 18, 1988
50MG A071343 001 Apr 18, 1988
VINTAGE 25MG N018829 002 Aug 06, 1984
50MG A070651 001 Mar 05, 1986
50MG N018829 001 Aug 06, 1984
WATSON LABS 25MG A070529 001 Oct 18, 1985
25MG A070784 001 Aug 20, 1986
25MG A072996 001 Jul 31, 1991
25MG N018690 001 Jul 31, 1984
50MG A070530 001 Oct 18, 1985
50MG A070785 001 Aug 20, 1986
50MG A071635 001 May 18, 1987
50MG A072997 001 Jul 31, 1991
50MG N018690 002 Jul 31, 1984
CAPSULE, EXTENDED RELEASE;ORAL
INDOCIN SR
IROKO PHARMS 75MG N018185 001 Feb 23, 1982
INDOMETHACIN
ABLE 75MG A076114 001 Feb 06, 2002
INWOOD LABS 75MG A072410 001 Mar 15, 1989
SUPPOSITORY;RECTAL
INDOCIN
IROKO PHARMS 50MG N017814 001 Aug 13, 1984
SUSPENSION;ORAL
INDOMETHACIN
ROXANE 25MG/5ML A071412 001 Mar 18, 1987
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
INJECTABLE;SUBCUTANEOUS
NOVOLOG MIX 50/50
NOVO NORDISK INC 50 UNITS/ML;50 UNITS/ML N021810 001 Aug 26, 2008
NOVOLOG MIX 70/30 PENFILL
NOVO NORDISK INC 210 UNITS/3ML;90 UNITS/3ML (70 N021172 002 Nov 01, 2001
UNITS/ML; 30 UNITS/ML)
210 UNITS/3ML;90 UNITS/3ML (70 N021172 003 Nov 01, 2001
UNITS/ML; 30 UNITS/ML)
INSULIN ASPART RECOMBINANT
INJECTABLE;SUBCUTANEOUS
NOVOLOG INNOLET
NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N020986 004 Apr 23, 2004
INSULIN DETEMIR RECOMBINANT
INJECTABLE;SUBCUTANEOUS
LEVEMIR INNOLET
NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N021536 003 Jun 16, 2005
LEVEMIR PENFILL
NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N021536 004 Jun 16, 2005
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT
INJECTABLE;INJECTION
HUMALOG MIX 50/50 PEN
LILLY 50 UNITS/ML;50 UNITS/ML N021018 003 Dec 22, 1999
HUMALOG MIX 75/25 PEN
LILLY 75 UNITS/ML;25 UNITS/ML N021017 003 Dec 22, 1999
INSULIN LISPRO RECOMBINANT
INJECTABLE;INJECTION
HUMALOG PEN
LILLY 100 UNITS/ML N020563 002 Aug 06, 1998
INSULIN PORK
INJECTABLE;INJECTION
ILETIN I
LILLY 500 UNITS/ML N017931 001
INSULIN
NOVO NORDISK INC 40 UNITS/ML N017926 001
REGULAR INSULIN
NOVO NORDISK INC 100 UNITS/ML N017926 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
INSULIN PURIFIED BEEF
INJECTABLE;INJECTION
REGULAR ILETIN II
LILLY
INSULIN PURIFIED PORK
INJECTABLE;INJECTION
ILETIN II
LILLY
REGULAR ILETIN II (PORK)
LILLY 100 UNITS/ML
REGULAR PURIFIED PORK INSULIN
NOVO NORDISK INC 100 UNITS/ML
VELOSULIN
NOVO NORDISK INC 100 UNITS/ML
INSULIN PURIFIED PORK; INSULIN SUSP ISOPHANE PURIFIED PORK
INJECTABLE;INJECTION
INSULIN NORDISK MIXTARD (PORK)
NOVO NORDISK INC
INSULIN RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN BR
LILLY
VELOSULIN BR
NOVO NORDISK INC
POWDER;INHALATION
EXUBERA
PFIZER
DISCONTINUED DRUG PRODUCT LIST
100 UNITS/ML
500 UNITS/ML
30 UNITS/ML;70 UNITS/ML
100 UNITS/ML
100 UNITS/ML
1MG/INH
3MG/INH
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN 50/50
LILLY 50 UNITS/ML;50 UNITS/ML
INSULIN RECOMBINANT PURIFIED HUMAN
INJECTABLE;INJECTION
NOVOLIN R
NOVO NORDISK INC
VELOSULIN BR HUMAN
100 UNITS/ML
NOVO NORDISK INC 100 UNITS/ML
6-176( of 322)
N018478 001
N018344 002
N018344 001
N018381 001
N018193 001
N018195 001
N019529 001 Apr 28, 1986
N021028 001 Jul 19, 1999
N021868 001 Jan 27, 2006
N021868 002 Jan 27, 2006
N020100 001 Apr 29, 1992
N018778 001 Aug 30, 1983
N019450 001 May 30, 1986
INSULIN RECOMBINANT PURIFIED HUMAN; INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN
INJECTABLE;INJECTION
MIXTARD HUMAN 70/30
BAYER PHARMS
NOVOLIN 70/30
NOVO NORDISK INC
INSULIN SUSP ISOPHANE BEEF
INJECTABLE;INJECTION
NPH INSULIN
NOVO NORDISK INC
INSULIN SUSP ISOPHANE BEEF/PORK
INJECTABLE;INJECTION
NPH ILETIN I (BEEF-PORK)
LILLY
30 UNITS/ML;70 UNITS/ML
30 UNITS/ML;70 UNITS/ML
40 UNITS/ML
100 UNITS/ML
40 UNITS/ML
100 UNITS/ML
INSULIN SUSP ISOPHANE PURIFIED BEEF
INJECTABLE;INJECTION
NPH ILETIN II
LILLY 100 UNITS/ML
INSULIN SUSP ISOPHANE PURIFIED PORK
INJECTABLE;INJECTION
INSULIN INSULATARD NPH NORDISK
NOVO NORDISK INC 100 UNITS/ML
NPH ILETIN II (PORK)
LILLY 100 UNITS/ML
NPH PURIFIED PORK ISOPHANE INSULIN
NOVO NORDISK INC 100 UNITS/ML
N019585 001 Mar 11, 1988
N019441 001 Jul 11, 1986
N017929 001
N017929 003
N017936 001
N017936 002
N018479 001
N018194 001
N018345 001
N018623 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN
INJECTABLE;INJECTION
INSULATARD NPH HUMAN
NOVO NORDISK INC
NOVOLIN N
100 UNITS/ML
NOVO NORDISK INC 100 UNITS/ML
INSULIN SUSP PROTAMINE ZINC BEEF/PORK
INJECTABLE;INJECTION
PROTAMINE ZINC & ILETIN I (BEEF-PORK)
LILLY 40 UNITS/ML
100 UNITS/ML
INSULIN SUSP PROTAMINE ZINC PURIFIED BEEF
INJECTABLE;INJECTION
PROTAMINE ZINC AND ILETIN II
LILLY 100 UNITS/ML
PROTAMINE ZINC INSULIN
BRISTOL MYERS SQUIBB 40 UNITS/ML
100 UNITS/ML
INSULIN SUSP PROTAMINE ZINC PURIFIED PORK
INJECTABLE;INJECTION
PROTAMINE ZINC AND ILETIN II (PORK)
LILLY 100 UNITS/ML
INSULIN ZINC SUSP BEEF
INJECTABLE;INJECTION
LENTE INSULIN
NOVO NORDISK INC 40 UNITS/ML
100 UNITS/ML
INSULIN ZINC SUSP EXTENDED BEEF
INJECTABLE;INJECTION
ULTRALENTE INSULIN
NOVO NORDISK INC 100 UNITS/ML
INSULIN ZINC SUSP EXTENDED PURIFIED BEEF
INJECTABLE;INJECTION
ULTRALENTE
NOVO NORDISK INC 100 UNITS/ML
INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN U
LILLY 40 UNITS/ML
100 UNITS/ML
INSULIN ZINC SUSP PROMPT BEEF
INJECTABLE;INJECTION
SEMILENTE INSULIN
NOVO NORDISK INC 100 UNITS/ML
INSULIN ZINC SUSP PROMPT PURIFIED PORK
INJECTABLE;INJECTION
SEMILENTE
NOVO NORDISK INC 100 UNITS/ML
INSULIN ZINC SUSP PURIFIED BEEF
INJECTABLE;INJECTION
LENTE ILETIN II
LILLY 100 UNITS/ML
INSULIN ZINC SUSP PURIFIED BEEF/PORK
INJECTABLE;INJECTION
LENTARD
NOVO NORDISK INC 100 UNITS/ML
INSULIN ZINC SUSP PURIFIED PORK
INJECTABLE;INJECTION
LENTE
NOVO NORDISK INC 100 UNITS/ML
LENTE ILETIN II (PORK)
LILLY 100 UNITS/ML
6-177( of 322)
N019449 001 May 30, 1986
N019065 001 Jan 23, 1985
N017932 001
N017932 002
N018476 001
N017928 001
N017928 003
N018346 001
N017998 001
N017998 003
N017997 003
N018385 001
N019571 001 Jun 10, 1987
N019571 002 Jun 10, 1987
N017996 003
N018382 001
N018477 001
N018384 001
N018383 001
N018347 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
INSULIN ZINC SUSP RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN L
LILLY
NOVOLIN L
100 UNITS/ML
NOVO NORDISK INC 100 UNITS/ML
INSULIN ZINC SUSP SEMISYNTHETIC PURIFIED HUMAN
INJECTABLE;INJECTION
NOVOLIN L
NOVO NORDISK INC 100 UNITS/ML
INULIN
INJECTABLE;INJECTION
INULIN AND SODIUM CHLORIDE
ISO TEX 100MG/ML
INVERT SUGAR
INJECTABLE;INJECTION
TRAVERT 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 10GM/100ML
IOBENGUANE SULFATE I-131
INJECTABLE;INJECTION
IOBENGUANE SULFATE I 131
PHARMALUCENCE 2.3mCi/ML
IOCETAMIC ACID
TABLET;ORAL
CHOLEBRINE
MALLINCKRODT 750MG
IODAMIDE MEGLUMINE
INJECTABLE;INJECTION
RENOVUE-65
BRACCO 65%
RENOVUE-DIP
BRACCO 24%
IODIPAMIDE MEGLUMINE
INJECTABLE;INJECTION
CHOLOGRAFIN MEGLUMINE
BRACCO 10.3%
IODIPAMIDE SODIUM
INJECTABLE;INJECTION
CHOLOGRAFIN SODIUM
BRACCO 20%
IODOHIPPURATE SODIUM I-123
INJECTABLE;INJECTION
NEPHROFLOW
GE HEALTHCARE 1mCi/ML
IODOHIPPURATE SODIUM I-131
INJECTABLE;INJECTION
HIPPURAN I 131
MALLINCKRODT 0.25mCi/ML
HIPPUTOPE
BRACCO 1-2mCi/VIAL
IODOHIPPURATE SODIUM I 131
PHARMALUCENCE 0.2mCi/ML
IODOXAMATE MEGLUMINE
INJECTABLE;INJECTION
CHOLOVUE
BRACCO 9.9%
40.3%
IOFETAMINE HYDROCHLORIDE I-123
INJECTABLE;INJECTION
SPECTAMINE
IMP 1mCi/ML
6-178( of 322)
N019377 002 Sep 30, 1985
N019965 001 Jun 25, 1991
N018777 001 Aug 30, 1983
N002282 001
N016717 001
N020084 001 Mar 25, 1994
N017129 001
N017902 001
N017903 001
N009321 007
N009321 001
N018289 001 Dec 28, 1984
N016666 001
N015419 002
N017313 001
N018077 001
N018076 001
N019432 001 Dec 24, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-179( of 322)
IOHEXOL
INJECTABLE;INJECTION
OMNIPAQUE 210
GE HEALTHCARE 45.3% N018956 006 Jun 30, 1989
SOLUTION;URETHRAL
OMNIPAQUE 70
GE HEALTHCARE 15.1% N018956 007 Jun 01, 1994
IOPAMIDOL
INJECTABLE;INJECTION
IOPAMIDOL
BAXTER HLTHCARE 41% A074629 001 Nov 06, 1996
51% A074629 004 Mar 31, 1998
61% A074629 002 Nov 06, 1996
76% A074629 003 Nov 06, 1996
HOSPIRA 61% A074734 001 Dec 10, 1996
76% A074734 002 Dec 10, 1996
IOPAMIDOL-200
COOK IMAGING 41% A074881 001 Jul 28, 2000
HOSPIRA 41% A074898 001 Dec 30, 1997
IOPAMIDOL-200 IN PLASTIC CONTAINER
HOSPIRA 41% A074636 001 Dec 30, 1997
IOPAMIDOL-250
COOK IMAGING 51% A074881 002 Jul 28, 2000
HOSPIRA 51% A074898 002 Dec 30, 1997
51% A075005 001 Feb 24, 1998
IOPAMIDOL-250 IN PLASTIC CONTAINER
HOSPIRA 51% A074636 002 Dec 30, 1997
IOPAMIDOL-300
ABBVIE 61% A074638 001 Apr 30, 1997
COOK IMAGING 61% A074881 003 Jul 28, 2000
HOSPIRA 61% A074898 003 Dec 30, 1997
61% A075005 002 Feb 24, 1998
IOPAMIDOL-300 IN PLASTIC CONTAINER
HOSPIRA 61% A074636 003 Dec 30, 1997
61% A074637 001 Apr 03, 1997
IOPAMIDOL-370
COOK IMAGING 76% A074881 004 Jul 28, 2000
HOSPIRA 76% A074898 004 Dec 30, 1997
76% A075005 003 Feb 24, 1998
IOPAMIDOL-370 IN PLASTIC CONTAINER
HOSPIRA 76% A074636 004 Dec 30, 1997
ISOVUE-128
BRACCO 26% N018735 005 Oct 21, 1986
ISOVUE-200
BRACCO 41% N020327 001 Oct 12, 1994
IOPANOIC ACID
TABLET;ORAL
TELEPAQUE
GE HEALTHCARE 500MG N008032 001
IOPHENDYLATE
INJECTABLE;INJECTION
PANTOPAQUE
ALCON 100% N005319 001
IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM
INJECTABLE;INJECTION
VASCORAY
MALLINCKRODT 52%;26% N016783 001
IOTHALAMATE SODIUM
INJECTABLE;INJECTION
ANGIO-CONRAY
MALLINCKRODT 80% N013319 001
CONRAY 325
MALLINCKRODT 54.3% N017685 001
CONRAY 400
MALLINCKRODT 66.8% N014295 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
IOTROLAN
INJECTABLE;INTRATHECAL
OSMOVIST 190
BAYER HLTHCARE
OSMOVIST 240
BAYER HLTHCARE
IOVERSOL
INJECTABLE;INJECTION
OPTIRAY 160
MALLINCKRODT
OPTIRAY 240
MALLINCKRODT
OPTIRAY 320
MALLINCKRODT
IPODATE CALCIUM
GRANULE;ORAL
ORAGRAFIN CALCIUM
BRACCO
IPODATE SODIUM
CAPSULE;ORAL
BILIVIST
BAYER HLTHCARE
ORAGRAFIN SODIUM
BRACCO
IPRATROPIUM BROMIDE
AEROSOL, METERED;INHALATION
ATROVENT
BOEHRINGER INGELHEIM
SOLUTION;INHALATION
ATROVENT
BOEHRINGER INGELHEIM
IPRATROPIUM BROMIDE
ACTAVIS MID ATLANTIC
APOTEX INC
PHARMASCIENCE INC
ROXANE
TEVA PHARMS USA
SPRAY, METERED;NASAL
IPRATROPIUM BROMIDE
APOTEX INC
IRINOTECAN HYDROCHLORIDE
INJECTABLE;INJECTION
IRINOTECAN HYDROCHLORIDE
SANDOZ
IRON DEXTRAN
INJECTABLE;INJECTION
IRON DEXTRAN
SANOFI AVENTIS US
IRON SUCROSE
INJECTABLE;INTRAVENOUS
VENOFER
LUITPOLD
ISOETHARINE HYDROCHLORIDE
SOLUTION;INHALATION
BETA-2
NEPHRON
BRONKOSOL
SANOFI AVENTIS US
ISOETHARINE HYDROCHLORIDE
ALPHARMA US PHARMS
ASTRAZENECA
40.6%
51.3%
34%
51%
68%
3GM/PACKET
500MG
500MG
0.018MG/INH
0.02%
0.02%
0.02%
0.02%
0.02%
0.02%
0.021MG/SPRAY
0.042MG/SPRAY
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
EQ 50MG IRON/ML
EQ 65MG BASE/3.25ML (EQ 20MG BASE/ML)
EQ 75MG BASE/3.75ML (EQ 20MG BASE/ML)
1%
0.25%
1%
1%
0.062%
0.062%
0.125%
0.125%
6-180( of 322)
N019580 001 Dec 07, 1989
N019580 002 Dec 07, 1989
N019710 003 Dec 30, 1988
N020923 001 May 28, 1998
N020923 002 May 29, 1998
N012968 001
A087768 001 Aug 11, 1982
N012967 001
N019085 001 Dec 29, 1986
N020228 001 Sep 29, 1993
A075111 001 Apr 22, 1999
A075441 001 Mar 28, 2001
A075507 001 Jan 19, 2001
A075867 001 Jul 22, 2002
A075313 001 Feb 07, 2000
A076156 001 Apr 18, 2003
A076155 001 Apr 18, 2003
A077994 001 Feb 27, 2008
A077994 002 Feb 27, 2008
N010787 002
N021135 005 Mar 29, 2013
N021135 003 Mar 29, 2005
A086711 001
N012339 009
N012339 008
A087101 001
A087937 001 Nov 15, 1982
A089614 001 Jun 13, 1991
A087938 001 Nov 15, 1982
A089615 001 Jun 13, 1991
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ISOETHARINE HYDROCHLORIDE
SOLUTION;INHALATION
ISOETHARINE HYDROCHLORIDE
BAXTER HLTHCARE
DEY
INTL MEDICATION
PARKE DAVIS
ROXANE
0.167%
0.167%
0.2%
0.2%
0.25%
0.25%
0.08%
0.14%
0.25%
0.08%
0.1%
0.17%
0.25%
1%
0.077%
0.08%
0.1%
0.143%
0.167%
0.2%
0.25%
1%
0.5%
1%
0.1%
0.125%
0.167%
0.2%
0.25%
1%
ISOETHARINE HYDROCHLORIDE S/F
DEY
ISOETHARINE MESYLATE
AEROSOL, METERED;INHALATION
BRONKOMETER
SANOFI AVENTIS US
ISOETHARINE MESYLATE
ALPHARMA US PHARMS
ISOFLURANE
LIQUID;INHALATION
ISOFLURANE
MARSAM PHARMS LLC
ISOFLUROPHATE
OINTMENT;OPHTHALMIC
FLOROPRYL
MERCK
ISONIAZID
INJECTABLE;INJECTION
NYDRAZID
SANDOZ
RIMIFON
ROCHE
SYRUP;ORAL
ISONIAZID
MIKART
LANIAZID
LANNETT
RIMIFON
ROCHE
TABLET;ORAL
DOW-ISONIAZID
DOW PHARM
0.08%
0.1%
0.17%
0.25%
1%
0.34MG/INH
0.34MG/INH
99.9%
0.025%
100MG/ML
25MG/ML
100MG/ML
50MG/5ML
50MG/5ML
50MG/5ML
300MG
6-181( of 322)
A088470 001 Mar 14, 1984
A089616 001 Jun 13, 1991
A088471 001 Mar 14, 1984
A089617 001 Jun 13, 1991
A088472 001 Mar 14, 1984
A089618 001 Jun 13, 1991
A088144 001 Jul 29, 1983
A088145 001 Mar 26, 1984
A088146 001 Aug 01, 1983
A088187 001 Dec 03, 1982
A087389 001
A087390 001
A088188 001 Dec 03, 1982
A086763 001
A086651 001
A086651 002
A086651 003
A086651 004
A086651 005
A086651 006
A086651 007
A086651 008
A085997 001
A085889 001
A087396 001
A087025 001
A088226 001 Sep 16, 1983
A087324 001
A088275 001 Jun 03, 1983
A086899 001
A089817 001 Nov 22, 1988
A089818 001 Nov 22, 1988
A089819 001 Nov 22, 1988
A089820 001 Nov 22, 1988
A089252 001 Sep 15, 1986
N012339 007
A087858 001 Aug 21, 1984
A074393 001 May 12, 1995
N010656 001
N008662 001
N008420 002
N008420 003
A081118 001 Jul 21, 1997
A089243 001 Feb 03, 1986
N008420 001
A080330 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-182( of 322)
A080134 003
A080134 004
A080935 001
A088231 001 Mar 17, 1983
A088119 001 Mar 17, 1983
A083632 001
A080153 001
A080270 001
A083610 001
N008499 002
N008499 003
A040090 001 Jun 26, 1997
A040090 002 Jun 26, 1997
A080941 001
A080136 001
A083633 001
A084050 001
N008428 001
N008428 002
N008428 003
A083060 001
A085091 001
A080368 001
A080368 002
A080132 003 Jul 14, 1982
A080132 004 Jul 14, 1982
A080522 001
A080401 001
A080523 001
A085790 001
A080521 001
A083178 001
A085784 001
A080212 001
A087425 001
A080120 002
A080140 001
A080140 002
N008392 003
A080126 001
A080126 002
A065221 001 Jul 29, 2005
N010744 001
N010375 004
A085904 001
N011178 001
N016814 001
A083431 001
A083486 001
ISONIAZID
TABLET;ORAL
HYZYD
MEDPOINTE PHARM HLC
INH
NOVARTIS
ISONIAZID
DURAMED PHARMS BARR
HALSEY
IMPAX LABS
IVAX SUB TEVA PHARMS
LILLY
MIKART
MK LABS
MUTUAL PHARM
NEXGEN PHARMA INC
PANRAY
PERRIGO
PHARMAVITE
PHOENIX LABS NY
PUREPAC PHARM
WATSON LABS
WEST WARD
WHITEWORTH TOWN PLSN
LANIAZID
LANNETT
NYDRAZID
BRISTOL MYERS SQUIBB
STANOZIDE
EVERYLIFE
ISONIAZID; RIFAMPIN
CAPSULE;ORAL
RIFAMPIN AND ISONIAZID
WEST WARD PHARM CORP
ISOPROPAMIDE IODIDE
TABLET;ORAL
DARBID
GLAXOSMITHKLINE
ISOPROTERENOL HYDROCHLORIDE
AEROSOL, METERED;INHALATION
ISOPROTERENOL HYDROCHLORIDE
3M
ALPHARMA US PHARMS
ISUPREL
SANOFI AVENTIS US
DISC;INHALATION
NORISODRINE AEROTROL
ABBOTT
INJECTABLE;INJECTION
ISOPROTERENOL HYDROCHLORIDE
ABRAXIS PHARM
BAXTER HLTHCARE
100MG
300MG
300MG
100MG
300MG
50MG
100MG
100MG
300MG
100MG
300MG
100MG
300MG
100MG
100MG
300MG
100MG
50MG
100MG
300MG
100MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
100MG
100MG
300MG
300MG
300MG
100MG
300MG
100MG
50MG
100MG
100MG
100MG
300MG
150MG;300MG
EQ 5MG BASE
0.12MG/INH
0.12MG/INH
0.103MG/INH
0.25%
0.2MG/ML
0.2MG/ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
ISOPROTERENOL HYDROCHLORIDE
INJECTABLE;INJECTION
ISOPROTERENOL HYDROCHLORIDE
HOSPIRA
INTL MEDICATION
SOLUTION;INHALATION
AEROLONE
LILLY
ISOPROTERENOL HYDROCHLORIDE
ARMOUR PHARM
DEY
PARKE DAVIS
ISUPREL
SANOFI AVENTIS US
VAPO-ISO
FISONS
TABLET;RECTAL, SUBLINGUAL
ISUPREL
SANOFI AVENTIS US
0.02MG/ML
0.2MG/ML
0.2MG/ML
0.25%
0.031%
0.062%
0.5%
0.25%
0.5%
0.5%
1%
0.5%
10MG
15MG
ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE
AEROSOL, METERED;INHALATION
DUO-MEDIHALER
3M 0.16MG/INH;0.24MG/INH
ISOPROTERENOL SULFATE
AEROSOL, METERED;INHALATION
MEDIHALER-ISO
3M
POWDER;INHALATION
NORISODRINE
ABBVIE
ISOSORBIDE
SOLUTION;ORAL
ISMOTIC
ALCON
ISOSORBIDE DINITRATE
CAPSULE, EXTENDED RELEASE;ORAL
ISORDIL
WYETH AYERST
TABLET;ORAL
ISOSORBIDE DINITRATE
MUTUAL PHARM
SUPERPHARM
WATSON LABS
SORBITRATE
ASTRAZENECA
TABLET;SUBLINGUAL
ISORDIL
BIOVAIL
0.08MG/INH
10%
25%
100GM/220ML
40MG
5MG
10MG
20MG
30MG
5MG
10MG
20MG
5MG
10MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
A083283 001
A083346 001
A083724 001
N007245 001
A087935 001
A087936 001
A086764 001
A085994 001
A085540 001
N006327 002
N006327 003
N016813 001
N006328 001
N006328 002
N013296 001
N010375 003
N006905 003
N006905 002
N017063 001
N012882 002
A086166 002
A086169 001
A086167 001
A087564 001
A089190 001
A089191 001
A089192 001
A086034 001
A086032 001
N016192 001
N016192 002
A086405 002
A088124 001
A088125 001
N012940 004
N012940 003
N012940 005
6-183( of 322)
Nov 18, 1982
Nov 18, 1982
Jan 04, 1982
Jul 29, 1988
Sep 19, 1986
Sep 19, 1986
Sep 19, 1986
Sep 18, 1986
Feb 17, 1987
Feb 17, 1987
Feb 17, 1987
Jan 06, 1988
Jan 07, 1988
Apr 01, 1996
Apr 01, 1996
Aug 21, 1990
Aug 21, 1990
Aug 21, 1990
Jul 29, 1988
Jul 29, 1988
Jul 29, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-184( of 322)
ISOSORBIDE DINITRATE
TABLET;SUBLINGUAL
ISOSORBIDE DINITRATE
MUTUAL PHARM 2.5MG A084204 001 Sep 18, 1986
5MG A086168 001 Sep 18, 1986
10MG A087545 001 Sep 18, 1986
SANDOZ 2.5MG A086225 001 Feb 19, 1988
5MG A086222 001 Feb 19, 1988
WATSON LABS 2.5MG **Federal Register determination A086033 001 Feb 26, 1988
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
5MG **Federal Register determination A086031 001 Sep 29, 1987
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
WEST WARD 2.5MG A086054 001 Oct 29, 1987
WEST WARD PHARM CORP 5MG A086055 001 Nov 02, 1987
SORBITRATE
ASTRAZENECA 2.5MG N016191 002 Apr 01, 1996
5MG N016191 001 Apr 01, 1996
TABLET, CHEWABLE;ORAL
SORBITRATE
ASTRAZENECA 5MG N016776 002 Apr 01, 1996
10MG N016776 003 Apr 01, 1996
TABLET, EXTENDED RELEASE;ORAL
ISORDIL
WYETH AYERST 40MG N012882 001 Jul 29, 1988
ISOSORBIDE MONONITRATE
TABLET;ORAL
ISMO
PROMIUS PHARMA 20MG N019091 001 Dec 30, 1991
TABLET, EXTENDED RELEASE;ORAL
IMDUR
SCHERING PLOUGH 30MG N020225 001 Aug 12, 1993
60MG N020225 002 Aug 12, 1993
120MG N020225 003 Mar 30, 1995
ISOSORBIDE MONONITRATE
ALKERMES GAINESVILLE 60MG A075041 001 Sep 22, 1998
IVAX SUB TEVA PHARMS 30MG A075448 002 Aug 07, 2001
60MG A075448 001 Jun 19, 2000
120MG A075448 003 Aug 07, 2001
SKYEPHARMA AG 60MG A075166 001 Oct 07, 1999
ISOTRETINOIN
CAPSULE;ORAL
ACCUTANE
HOFFMANN LA ROCHE 10MG N018662 002 May 07, 1982
20MG N018662 004 Mar 28, 1983
40MG N018662 003 May 07, 1982
ISRADIPINE
CAPSULE;ORAL
DYNACIRC
SMITHKLINE BEECHAM 2.5MG N019546 001 Dec 20, 1990
5MG N019546 002 Dec 20, 1990
TABLET, EXTENDED RELEASE;ORAL
DYNACIRC CR
GLAXOSMITHKLINE LLC 5MG **Federal Register determination N020336 001 Jun 01, 1994
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
10MG **Federal Register determination N020336 002 Jun 01, 1994
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
ITRACONAZOLE
INJECTABLE;INJECTION
SPORANOX
JANSSEN PHARMS 10MG/ML N020966 001 Mar 30, 1999
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
IVERMECTIN
TABLET;ORAL
STROMECTOL
MERCK SHARP DOHME 6MG
KANAMYCIN SULFATE
CAPSULE;ORAL
KANTREX
APOTHECON EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
INJECTABLE;INJECTION
KANAMYCIN
HIKMA MAPLE EQ 1GM BASE/3ML
EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
KANAMYCIN SULFATE
ABRAXIS PHARM EQ 1GM BASE/3ML
EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
INTL MEDICATION EQ 1GM BASE/3ML
EQ 500MG BASE/2ML
LOCH EQ 1GM BASE/3ML
EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
PHARMAFAIR EQ 1GM BASE/3ML
EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
SOLOPAK EQ 1GM BASE/3ML
EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
WARNER CHILCOTT EQ 1GM BASE/3ML
WATSON LABS EQ 1GM BASE/3ML
KANTREX
APOTHECON EQ 1GM BASE/3ML
EQ 1GM BASE/3ML
EQ 1GM BASE/3ML
EQ 75MG BASE/2ML
EQ 75MG BASE/2ML
EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
EQ 500MG BASE/2ML
EQ 500MG BASE/2ML
KLEBCIL
KING PHARMS EQ 1GM BASE/3ML
EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
KETOCONAZOLE
CREAM;TOPICAL
NIZORAL
JANSSEN PHARMA 2%
SUSPENSION;ORAL
NIZORAL
JANSSEN PHARMA 100MG/5ML
TABLET;ORAL
KETOCONAZOLE
AAIPHARMA LLC 200MG
TEVA 200MG
KETOPROFEN
CAPSULE;ORAL
KETOPROFEN
SANDOZ 50MG
75MG
TEVA 25MG
ORUDIS
WYETH AYERST 25MG
50MG
75MG
CAPSULE, EXTENDED RELEASE;ORAL
KETOPROFEN
ALKERMES GAINESVILLE 200MG
6-185( of 322)
N050742 001 Nov 22, 1996
A060516 001
A061911 001
A062726 001 Mar 06, 1987
A062324 003
A062324 001
A062324 002
A062504 003 Apr 05, 1984
A062504 001 Apr 05, 1984
A062504 002 Apr 05, 1984
A062466 002 Sep 30, 1983
A062466 001 Sep 30, 1983
A063025 001 Jul 31, 1992
A063021 001 Jul 31, 1992
A063022 001 Jul 31, 1992
A062669 001 May 07, 1987
A062668 001 May 07, 1987
A062672 001 May 07, 1987
A062605 002 Feb 26, 1986
A062605 003 Feb 26, 1986
A062605 001 Feb 26, 1986
A063092 001 Oct 11, 1989
A062520 003 May 09, 1985
A061655 002
A061901 002
A062564 003 Sep 21, 1984
A061655 003
A061901 003
A062564 001 Sep 21, 1984
A061655 001
A061901 001
A062564 002 Sep 21, 1984
A062170 003
A062170 001
A062170 002
N019084 001 Dec 31, 1985
A070767 001 Nov 07, 1986
A075341 001 Jul 27, 1999
A074971 001 Jun 15, 1999
A074024 001 Dec 29, 1995
A074024 002 Dec 29, 1995
A073515 001 Dec 22, 1992
N018754 001 Jul 31, 1987
N018754 002 Jan 09, 1986
N018754 003 Jan 09, 1986
A074879 001 Dec 10, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-186( of 322)
KETOPROFEN
CAPSULE, EXTENDED RELEASE;ORAL
ORUVAIL
WYETH PHARMS INC
TABLET;ORAL
ACTRON
100MG
150MG
200MG
N019816 003
N019816 002
N019816 001
Feb 08, 1995
Feb 08, 1995
Sep 24, 1993
BAYER
KETOPROFEN
12.5MG N020499 001 Oct 06, 1995
PERRIGO
ORUDIS KT
12.5MG A075364 001 Feb 07, 2002
WYETH CONS 12.5MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N020429 001 Oct 06, 1995
KETOROLAC TROMETHAMINE
INJECTABLE;INJECTION
KETOROLAC TROMETHAMINE
AMPHASTAR PHARM
APOTEX INC
APOTHECON
BEDFORD
GLAND PHARMA LTD
HOSPIRA
LUITPOLD
TORADOL
15MG/ML
30MG/ML
15MG/ML
30MG/ML
30MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
A076209 001
A076209 002
A075631 002
A075626 001
A075631 001
A077201 001
A075348 001
A075348 002
A075230 002
A075230 001
A076722 001
A076722 002
A074801 001
A074801 002
A078145 001
A078145 002
Jul 21, 2004
Jul 21, 2004
Jun 29, 2001
Jul 24, 2001
Jun 29, 2001
Oct 14, 2005
Nov 28, 2000
Nov 28, 2000
Oct 25, 1999
Oct 25, 1999
Jul 27, 2004
Jul 27, 2004
Jun 05, 1997
Jun 05, 1997
Jan 14, 2008
Jan 14, 2008
ROCHE PALO
SOLUTION/DROPS;OPHTHALMIC
ACULAR PRESERVATIVE FREE
15MG/ML
30MG/ML
N019698 001
N019698 002
Nov 30, 1989
Nov 30, 1989
ALLERGAN
TABLET;ORAL
KETOROLAC TROMETHAMINE
0.5% N020811 001 Nov 03, 1997
ROXANE
WATSON LABS
TORADOL
10MG
10MG
A074790 001
A074955 001
Jun 26, 1997
Sep 19, 1997
ROCHE PALO 10MG N019645 001 Dec 20, 1991
KETOTIFEN FUMARATE
SOLUTION/DROPS;OPHTHALMIC
KETOTIFEN FUMARATE
APOTEX INC EQ 0.025% BASE A077354 001 May 09, 2006
KRYPTON, KR-81M
GAS;INHALATION
MPI KRYPTON 81M GENERATOR
GE HEALTHCARE N/A N018088 001
LABETALOL HYDROCHLORIDE
INJECTABLE;INJECTION
LABETALOL HYDROCHLORIDE
APOTEX INC
APOTHECON
HOSPIRA
NORMODYNE
5MG/ML
5MG/ML
5MG/ML
A076051 001
A075355 001
A075242 001
Jul 05, 2002
Nov 29, 1999
Sep 30, 1999
SCHERING
TRANDATE
5MG/ML N018686 001 Aug 01, 1984
PROMETHEUS LABS
TABLET;ORAL
LABETALOL HYDROCHLORIDE
5MG/ML N019425 001 Dec 31, 1985
APOTHECON
MUTUAL PHARM
100MG
200MG
300MG
100MG
A075223 001
A075223 002
A075223 003
A075215 001
Nov 20, 1998
Nov 20, 1998
Nov 20, 1998
Jul 29, 1999
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
LABETALOL HYDROCHLORIDE
TABLET;ORAL
LABETALOL HYDROCHLORIDE
200MG
300MG
TEVA 100MG
200MG
300MG
NORMODYNE
SCHERING 100MG
200MG
300MG
400MG
TRANDATE
PROMETHEUS LABS 100MG
200MG
300MG
400MG
LACTULOSE
SOLUTION;ORAL
CHRONULAC
SANOFI AVENTIS US 10GM/15ML
DUPHALAC
SOLVAY 10GM/15ML
EVALOSE
TEVA PHARMS 10GM/15ML
LACTULOSE
APOTEX INC 10GM/15ML
MORTON GROVE 10GM/15ML
PACO 10GM/15ML
LAXILOSE
NOSTRUM LABS 10GM/15ML
SOLUTION;ORAL, RECTAL
ACILAC
NOSTRUM LABS 10GM/15ML
CEPHULAC
SANOFI AVENTIS US 10GM/15ML
GENERLAC
MORTON GROVE 10GM/15ML
HEPTALAC
TEVA PHARMS 10GM/15ML
LACTULOSE
APOTEX INC 10GM/15ML
PACO 10GM/15ML
ROXANE 10GM/15ML
SOLVAY 10GM/15ML
PORTALAC
SOLVAY 10GM/15ML
LAMOTRIGINE
TABLET;ORAL
LAMICTAL
GLAXOSMITHKLINE LLC 50MG
250MG
LAMOTRIGINE
MATRIX LABS LTD 25MG
100MG
150MG
200MG
MYLAN 25MG
100MG
150MG
200MG
ROXANE 25MG
100MG
150MG
200MG
SANDOZ 25MG
100MG
150MG
200MG
WOCKHARDT 25MG
6-187( of 322)
A075215 002 Jul 29, 1999
A075215 003 Jul 29, 1999
A074989 001 Sep 30, 1998
A074989 002 Sep 30, 1998
A074989 003 Sep 30, 1998
N018687 001 Aug 31, 1987
N018687 002 Aug 01, 1984
N018687 003 Aug 01, 1984
N018687 004 Aug 01, 1984
N018716 001 May 24, 1985
N018716 002 Aug 01, 1984
N018716 003 Aug 01, 1984
N018716 004 Aug 01, 1984
N017884 001
A072372 001 Mar 22, 1989
A073497 001 May 28, 1993
A075911 001 Feb 21, 2002
A071841 001 Sep 22, 1988
A073160 001 Aug 25, 1992
A073686 001 May 28, 1993
A073685 001 May 28, 1993
N017657 001
A071842 001 Sep 27, 1988
A073504 001 May 28, 1993
A076645 001 Jul 28, 2003
A072029 001 Aug 25, 1992
A073590 001 May 29, 1992
N017906 001
A072374 001 Mar 22, 1989
N020241 006 Dec 27, 1994
N020241 004 Dec 27, 1994
A078443 001 Feb 11, 2009
A078443 002 Feb 11, 2009
A078443 003 Feb 11, 2009
A078443 004 Feb 11, 2009
A077428 001 Jan 27, 2009
A077428 002 Jan 27, 2009
A077428 003 Jan 27, 2009
A077428 004 Jan 27, 2009
A077392 001 Jan 27, 2009
A077392 002 Jan 27, 2009
A077392 003 Jan 27, 2009
A077392 004 Jan 27, 2009
A078645 001 Jan 27, 2009
A078645 002 Jan 27, 2009
A078645 003 Jan 27, 2009
A078645 004 Jan 27, 2009
A078982 001 Jan 27, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
LAMOTRIGINE
TABLET;ORAL
LAMOTRIGINE
TABLET, CHEWABLE;ORAL
LAMICTAL CD
GLAXOSMITHKLINE LLC
LAMOTRIGINE
SANDOZ
LANSOPRAZOLE
100MG
150MG
200MG
100MG
5MG
25MG
FOR SUSPENSION, DELAYED RELEASE;ORAL
PREVACID
TAKEDA PHARMS NA
INJECTABLE;INTRAVENOUS
PREVACID IV
TAKEDA PHARMS NA
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL
LANSOPRAZOLE
TEVA PHARMS 15MG
30MG
LANSOPRAZOLE; NAPROXEN
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
PREVACID NAPRAPAC 250 (COPACKAGED)
TAKEDA PHARMS NA 15MG,N/A;N/A,250MG **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
PREVACID NAPRAPAC 375 (COPACKAGED)
TAKEDA PHARMS NA 15MG,N/A;N/A,375MG
PREVACID NAPRAPAC 500 (COPACKAGED)
TAKEDA PHARMS NA 15MG,N/A;N/A,500MG
LANTHANUM CARBONATE
TABLET, CHEWABLE;ORAL
FOSRENOL
SHIRE LLC EQ 250MG BASE
LAPYRIUM CHLORIDE; UNDECOYLIUM CHLORIDE IODINE COMPLEX
15MG/PACKET
30MG/PACKET
30MG/VIAL
SOLUTION;TOPICAL
VIRAC REX
CHESEBROUGH PONDS
LATANOPROST
SOLUTION/DROPS;OPHTHALMIC
LATANOPROST
APOTEX INC
LEFLUNOMIDE
TABLET;ORAL
LEFLUNOMIDE
SANDOZ
LEPIRUDIN RECOMBINANT
INJECTABLE;INJECTION
REFLUDAN
BAYER HLTHCARE
LETROZOLE
TABLET;ORAL
LETROZOLE
SYNTHON PHARMS
LEUCOVORIN CALCIUM
FOR SOLUTION;ORAL
LEUCOVORIN CALCIUM
HOSPIRA
INJECTABLE;INJECTION
LEUCOVORIN CALCIUM
ABIC
0.5%;1.8%
0.005%
10MG
20MG
50MG/VIAL
2.5MG
EQ 60MG BASE/VIAL
EQ 3MG BASE/ML
EQ 50MG BASE/VIAL
A078982 002
A078982 003
A078982 004
N020764 003
A078409 002
A078409 003
N021281 001
N021281 002
N021566 001
A078730 001
A078730 002
N021507 002
N021507 003
N021507 004
N021468 001
N011914 001
A077697 001
A077085 001
A077085 002
N020807 001
A090196 001
N008107 003
A089352 001
A089353 001
6-188( of 322)
Jan 27, 2009
Jan 27, 2009
Jan 27, 2009
Aug 24, 1998
Jan 22, 2009
Jan 22, 2009
May 03, 2001
May 03, 2001
May 27, 2004
Oct 15, 2010
Oct 15, 2010
Nov 14, 2003
Nov 14, 2003
Nov 14, 2003
Oct 26, 2004
Mar 22, 2011
Sep 13, 2005
Sep 13, 2005
Mar 06, 1998
Jun 03, 2011
Jan 30, 1987
Jun 01, 1988
Jun 01, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-189( of 322)
LEUCOVORIN CALCIUM
INJECTABLE;INJECTION
LEUCOVORIN CALCIUM
ABRAXIS PHARM EQ 50MG BASE/VIAL A088939 001 Dec 01, 1986
ELKINS SINN EQ 50MG BASE/VIAL A070480 001 Jan 02, 1987
EQ 100MG BASE/VIAL A081224 001 Jun 03, 1994
HOSPIRA EQ 3MG BASE/ML N008107 001
EQ 50MG BASE/VIAL N008107 002
EQ 100MG BASE/VIAL N008107 004 May 23, 1988
EQ 350MG BASE/VIAL N008107 005 Apr 05, 1989
PHARMACHEMIE EQ 350MG BASE/VIAL A040262 001 Dec 15, 1999
PHARMACHEMIE USA EQ 50MG BASE/VIAL A089628 001 Apr 17, 1997
EQ 100MG BASE/VIAL A089915 001 Apr 17, 1997
TEVA PARENTERAL EQ 50MG BASE/VIAL A081278 001 Sep 28, 1993
LEUCOVORIN CALCIUM PRESERVATIVE FREE
HOSPIRA EQ 10MG BASE/ML A040147 001 Jun 25, 1997
LUITPOLD EQ 50MG BASE/VIAL A040338 001 Jan 31, 2001
TEVA PARENTERAL EQ 10MG BASE/ML A040332 001 Jun 28, 1999
WELLCOVORIN
GLAXOSMITHKLINE EQ 5MG BASE/ML A087439 001 Oct 19, 1982
EQ 25MG BASE/VIAL A089833 001 Jan 23, 1989
EQ 50MG BASE/VIAL A089465 001 Jan 23, 1989
EQ 100MG BASE/VIAL A089834 001 Jan 23, 1989
TABLET;ORAL
LEUCOVORIN CALCIUM
COREPHARMA EQ 5MG BASE A074544 001 Aug 28, 1997
EQ 25MG BASE A074544 002 Aug 28, 1997
PAR PHARM EQ 5MG BASE A071600 001 Oct 14, 1987
EQ 25MG BASE A071598 001 Oct 14, 1987
PHARMACHEMIE EQ 5MG BASE A073099 001 Mar 28, 1997
EQ 25MG BASE A073101 001 Mar 28, 1997
SANDOZ EQ 15MG BASE A075327 001 Mar 24, 1999
XANODYNE PHARM EQ 5MG BASE N018459 001 Jan 30, 1986
EQ 10MG BASE A071962 001 Nov 19, 1987
EQ 15MG BASE A071104 001 Mar 04, 1987
WELLCOVORIN
GLAXOSMITHKLINE EQ 5MG BASE N018342 001 Jul 08, 1983
EQ 25MG BASE N018342 002 Jul 08, 1983
LEUPROLIDE ACETATE
IMPLANT;IMPLANTATION
VIADUR
ORTHO MCNEIL JANSSEN EQ 65MG BASE N021088 001 Mar 03, 2000
INJECTABLE;INJECTION
LEUPROLIDE ACETATE
GENZYME 1MG/0.2ML A075721 001 Nov 29, 2001
LUPRON
ABBVIE ENDOCRINE INC 1MG/0.2ML N019010 001 Apr 09, 1985
LUPRON DEPOT-PED
ABBVIE ENDOCRINE INC 3.75MG/VIAL,7.5MG/VIAL;3.75MG/VIAL,7.5M N020263 003 Apr 16, 1993
G/VIAL
7.5MG/VIAL,7.5MG/VIAL;7.5MG/VIAL,7.5MG/ N020263 004 Apr 16, 1993
VIAL
LEVALLORPHAN TARTRATE
INJECTABLE;INJECTION
LORFAN
ROCHE 1MG/ML N010423 001
LEVAMISOLE HYDROCHLORIDE
TABLET;ORAL
ERGAMISOL
JANSSEN PHARMA EQ 50MG BASE N020035 001 Jun 18, 1990
LEVETIRACETAM
SOLUTION;ORAL
LEVETIRACETAM
APOTEX INC 100MG/ML A090187 001 Aug 05, 2011
TABLET;ORAL
LEVETIRACETAM
MYLAN 1GM A078731 004 Feb 10, 2009
250MG A078731 001 Feb 10, 2009
500MG A078731 002 Feb 10, 2009
750MG A078731 003 Feb 10, 2009
WATSON LABS FLORIDA 250MG A077408 001 Mar 02, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
LEVETIRACETAM
TABLET;ORAL
LEVETIRACETAM
TABLET, EXTENDED RELEASE;ORAL
LEVETIRACETAM
SANDOZ
LEVOBETAXOLOL HYDROCHLORIDE
SUSPENSION/DROPS;OPHTHALMIC
BETAXON
ALCON PHARMS LTD
LEVOBUNOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
LEVOBUNOLOL HYDROCHLORIDE
APOTEX INC
LEVOBUPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CHIROCAINE
PURDUE PHARMA LP
LEVOCABASTINE HYDROCHLORIDE
SUSPENSION/DROPS;OPHTHALMIC
LIVOSTIN
NOVARTIS
LEVOCARNITINE
SOLUTION;ORAL
CARNITOR
SIGMA TAU
LEVODOPA
CAPSULE;ORAL
BENDOPA
VALEANT PHARM INTL
DOPAR
SHIRE
LARODOPA
ROCHE
TABLET;ORAL
DOPAR
SHIRE
LARODOPA
ROCHE
LEVOFLOXACIN
INJECTABLE;INJECTION
LEVOFLOXACIN
AKORN
SOLUTION/DROPS;OPHTHALMIC
LEVOFLOXACIN
APOTEX INC
500MG
750MG
500MG
750MG
EQ 0.5% BASE
0.25%
0.5%
EQ 2.5MG BASE/ML
EQ 5MG BASE/ML
EQ 7.5MG BASE/ML
EQ 0.05% BASE
1GM/10ML
100MG
250MG
500MG
100MG
250MG
500MG
100MG
250MG
500MG
250MG
500MG
100MG
250MG
500MG
EQ 500MG/20ML (EQ 25MG/ML)
EQ 750MG/30ML (EQ 25MG/ML)
0.5%
6-190( of 322)
A077408 002 Mar 02, 2009
A077408 003 Mar 02, 2009
A091668 001 Nov 01, 2012
A091668 002 Nov 01, 2012
N021114 001 Feb 23, 2000
A075473 001 Aug 03, 2000
A075475 001 Aug 03, 2000
N020997 001 Aug 05, 1999
N020997 002 Aug 05, 1999
N020997 003 Aug 05, 1999
N020219 001 Nov 10, 1993
N018948 002 Apr 27, 1988
N016948 003
N016948 001
N016948 002
N016913 003
N016913 001
N016913 002
N016912 002
N016912 001
N016912 006
N016913 004
N016913 005
N016912 005
N016912 003
N016912 004
A091644 001 Jun 20, 2011
A091644 002 Jun 20, 2011
A078282 001 Dec 20, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-191( of 322)
LEVOLEUCOVORIN CALCIUM
SOLUTION;IV (INFUSION)
FUSILEV
SPECTRUM PHARMS EQ 250MG BASE/25ML (EQ 10MG BASE/ML) N020140 003 Apr 29, 2011
LEVOMEPROMAZINE
INJECTABLE;INJECTION
LEVOPROME
IMMUNEX 20MG/ML N015865 001
LEVOMETHADYL ACETATE HYDROCHLORIDE
CONCENTRATE;ORAL
ORLAAM
ROXANE 10MG/ML **Federal Register N020315 001 Jul 09, 1993
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
SOLVAY 0.05MG/ML;2% A085010 001
CARBOCAINE W/ NEO-COBEFRIN
EASTMAN KODAK 0.05MG/ML;2% N012125 002
ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
NOVOCOL 0.05MG/ML;2% A084697 001
MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN
GRAHAM CHEM 0.05MG/ML;2% A084850 002 Oct 21, 1983
POLOCAINE W/ LEVONORDEFRIN
DENTSPLY PHARM 0.05MG/ML;2% A089517 001 Apr 14, 1988
LEVONORDEFRIN; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
RAVOCAINE AND NOVOCAIN W/ NEO-COBEFRIN
EASTMAN KODAK 0.05MG/ML;2%;0.4% N008592 007
LEVONORGESTREL
IMPLANT;IMPLANTATION
LEVONORGESTREL
WYETH PHARMS INC 75MG/IMPLANT N020627 001 Aug 15, 1996
NORPLANT
POPULATION COUNCIL 36MG/IMPLANT N019897 001 Dec 10, 1990
NORPLANT II
POPULATION COUNCIL 75MG/IMPLANT N020544 001 Nov 01, 1996
NORPLANT SYSTEM IN PLASTIC CONTAINER
WYETH PHARMS INC 36MG/IMPLANT N020088 001 Dec 10, 1990
TABLET;ORAL
PLAN B
TEVA BRANDED PHARM 0.75MG N021045 001 Jul 28, 1999
LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS
CAPSULE;ORAL
NOVRAD
LILLY EQ 50MG BASE N012928 006
EQ 100MG BASE N012928 004
SUSPENSION;ORAL
NOVRAD
LILLY EQ 50MG BASE/5ML N012928 002
LEVORPHANOL TARTRATE
INJECTABLE;INJECTION
LEVO-DROMORAN
VALEANT PHARM INTL 2MG/ML N008719 001 Dec 19, 1991
TABLET;ORAL
LEVO-DROMORAN
VALEANT PHARM INTL 2MG N008720 001 Dec 19, 1991
LEVOTHYROXINE SODIUM
TABLET;ORAL
LEVOLET
VINTAGE 0.025MG N021137 001 Jun 06, 2003
0.05MG N021137 002 Jun 06, 2003
0.075MG N021137 003 Jun 06, 2003
0.088MG N021137 004 Jun 06, 2003
0.1MG N021137 005 Jun 06, 2003
0.112MG N021137 006 Jun 06, 2003
0.125MG N021137 007 Jun 06, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-192( of 322)
LEVOTHYROXINE SODIUM
TABLET;ORAL
LEVOLET
0.137MG N021137 008 Jun 06, 2003
0.15MG N021137 009 Jun 06, 2003
0.175MG N021137 010 Jun 06, 2003
0.2MG N021137 011 Jun 06, 2003
0.3MG N021137 012 Jun 06, 2003
LEVOTHYROXINE SODIUM
MERCK KGAA 0.025MG A076752 001 Jun 16, 2005
0.05MG A076752 002 Jun 16, 2005
0.075MG A076752 003 Jun 16, 2005
0.088MG A076752 004 Jun 16, 2005
0.1MG A076752 005 Jun 16, 2005
0.112MG A076752 006 Jun 16, 2005
0.125MG A076752 007 Jun 16, 2005
0.15MG A076752 008 Jun 16, 2005
0.175MG A076752 009 Jun 16, 2005
0.2MG A076752 010 Jun 16, 2005
0.3MG A076752 011 Jun 16, 2005
LEVOXYL
KING PHARMS R AND D 0.3MG N021301 012 May 25, 2001
NOVOTHYROX
MERCK KGAA 0.025MG N021292 001 May 31, 2002
0.05MG N021292 002 May 31, 2002
0.075MG N021292 003 May 31, 2002
0.088MG N021292 004 May 31, 2002
0.1MG N021292 005 May 31, 2002
0.112MG N021292 006 May 31, 2002
0.125MG N021292 007 May 31, 2002
0.137MG N021292 008 May 31, 2002
0.15MG N021292 009 May 31, 2002
0.175MG N021292 010 May 31, 2002
0.2MG N021292 011 May 31, 2002
0.3MG N021292 012 May 31, 2002
LIDOCAINE
AEROSOL;ORAL
XYLOCAINE
ASTRAZENECA 10% N014394 001
FILM, EXTENDED RELEASE;BUCCAL
DENTIPATCH
NOVEN 23MG/PATCH N020575 001 May 21, 1996
OINTMENT;TOPICAL
ALPHACAINE
CARLISLE 5% A084944 001
5% A084946 001
5% A084947 001
LIDOCAINE
GRAHAM CHEM 5% A080210 001
XYLOCAINE
ASTRAZENECA 5% N008048 001
PATCH;TOPICAL
DENTIPATCH
NOVEN 46.1MG/PATCH N020575 002 May 21, 1996
SOLUTION;TOPICAL
XYLOCAINE
ASTRAZENECA 5% N014127 001
SUPPOSITORY;RECTAL
XYLOCAINE
ASTRAZENECA 100MG N013077 001
LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
ALPHACAINE HYDROCHLORIDE
CARLISLE 2% A084721 001
LIDOCAINE HYDROCHLORIDE
ABBOTT 10% A087980 001 Feb 02, 1983
20% A089362 001 May 25, 1988
ABRAXIS PHARM 1% A080420 001
1% A086761 001
1.5% A080420 005
2% A080420 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE
AKORN
BEL MAR
DELL LABS
ELKINS SINN
GD SEARLE LLC
GRAHAM CHEM
HIKMA MAPLE
HOSPIRA
INTL MEDICATION
LUITPOLD
LYPHOMED
MILES
WATSON LABS
WYETH AYERST
2%
2%
2%
4%
20%
1%
2%
1%
2%
1%
2%
0.5%
4%
1%
2%
2%
1%
2%
1%
1.5%
2%
1%
1GM/VIAL
2%
2GM/VIAL
2%
1%
2%
1%
2%
1%
1%
2%
2%
1%
2%
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 100MG/100ML
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 200MG/100ML
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%
HOSPIRA 200MG/100ML
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 200MG/100ML
HOSPIRA 200MG/100ML
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 400MG/100ML
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%
HOSPIRA 400MG/100ML
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 800MG/100ML
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRA 1.5%
10%
20%
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
HIKMA MAPLE 1%
2%
INTL MEDICATION 4%
LIDOCATON
PHARMATON 2%
XYLOCAINE
ASTRAZENECA 1%
1.5%
2%
XYLOCAINE DENTAL
DENTSPLY PHARM 2%
6-193( of 322)
A080420 004
A086761 002
N017508 001
N017508 002
N017508 004
A085037 001
A085037 002
A080710 001
A080760 001
A083387 001
A083388 001
A085131 001
A084626 001
A083135 001
A083135 002
A080504 001
A080407 001
A080407 002
A040013 001 Jun 23, 1995
A088330 001 May 17, 1984
A088331 001 May 17, 1984
N017701 002
N018543 001
N017701 001
N018543 002
A083198 001
A080390 001
A080390 002
A080414 001
A080414 002
A080377 001
A083627 001
A080377 002
A083627 002
A083083 001
A083083 002
N018461 001
N018967 001 Mar 30, 1984
A083158 005
N018954 001 Jul 09, 1985
N018388 001
N018967 002 Mar 30, 1984
A083158 006
N018967 003 Mar 30, 1984
A088326 001 Jul 31, 1984
A088367 001 Jul 31, 1984
A088368 001 Jul 31, 1984
A084625 001
A084625 002
N017702 002
A084727 001 Aug 17, 1983
N010418 005
N010418 009
N010418 007
N021380 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
LIDOCAINE HYDROCHLORIDE
INJECTABLE;SPINAL
XYLOCAINE 1.5% W/ DEXTROSE 7.5%
FRESENIUS KABI USA 1.5%
XYLOCAINE 5% W/ GLUCOSE 7.5%
ASTRAZENECA 5%
JELLY;TOPICAL
ANESTACON
POLYMEDICA 2%
LIDOCAINE HYDROCHLORIDE
TEVA PHARMS USA 2%
SOLUTION;ORAL
LIDOCAINE HYDROCHLORIDE VISCOUS
ACTAVIS MID ATLANTIC 2%
INTL MEDICATION 2%
SOLUTION;TOPICAL
LARYNGOTRACHEAL ANESTHESIA KIT
KENDALL IL 4%
LIDOCAINE HYDROCHLORIDE
PACO 4%
LTA II KIT
HOSPIRA 4%
PEDIATRIC LTA KIT
ABBOTT 2%
HOSPIRA 2%
SYSTEM;INTRADERMAL
ZINGO
POWDER PHARMS 0.5MG
LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE
INJECTABLE;INJECTION
TERRAMYCIN
PFIZER
LIDOCAINE; PRILOCAINE
DISC;TOPICAL
EMLA
ASTRAZENECA
LINCOMYCIN HYDROCHLORIDE
CAPSULE;ORAL
LINCOCIN
PHARMACIA AND UPJOHN
INJECTABLE;INJECTION
LINCOMYCIN HYDROCHLORIDE
WATSON LABS
LINDANE
CREAM;TOPICAL
KWELL
REED AND CARNRICK
LOTION;TOPICAL
GAMENE
SOLA BARNES HIND
KWELL
REED AND CARNRICK
SCABENE
STIEFEL
SHAMPOO;TOPICAL
GAMENE
SOLA BARNES HIND
KWELL
REED AND CARNRICK
SCABENE
STIEFEL
2%;50MG/ML
2%;125MG/ML
2.5%;2.5%
EQ 250MG BASE
EQ 500MG BASE
EQ 300MG BASE/ML
1%
1%
1%
1%
1%
1%
1%
1%
1%
1%
6-194( of 322)
N016297 001
N010496 002 Jul 07, 1982
A080429 001
A081318 001 Apr 29, 1993
A086578 001
A086389 001 Feb 02, 1982
A087931 001 Jun 10, 1983
A089688 001 Jun 30, 1989
A088542 001 Jul 31, 1984
A088572 001 Jul 31, 1984
A085995 001
N022114 001 Aug 16, 2007
A060567 001
A060567 002
N020962 001 Feb 04, 1998
N050316 001
N050316 002
A063180 001 Apr 16, 1991
A084218 001
N006309 001
A084989 001
A084218 002
N006309 003
A086769 001
A084988 001
A084219 001
N010718 001
A087940 001 Apr 08, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
LINEZOLID
TABLET;ORAL
ZYVOX
PHARMACIA AND UPJOHN 400MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
LIOTHYRONINE SODIUM
TABLET;ORAL
LIOTHYRONINE SODIUM
WATSON LABS EQ 0.025MG BASE
EQ 0.05MG BASE
LIOTRIX (T4;T3)
TABLET;ORAL
EUTHROID-0.5
PARKE DAVIS 0.0075MG;0.0075MG
EUTHROID-1
PARKE DAVIS 0.015MG;0.015MG
EUTHROID-2
PARKE DAVIS 0.03MG;0.03MG
EUTHROID-3
PARKE DAVIS 0.045MG;0.045MG
THYROLAR-5
FOREST LABS 0.0625MG;0.25MG
LISINOPRIL
TABLET;ORAL
LISINOPRIL
SANDOZ 2.5MG
2.5MG
5MG
5MG
10MG
10MG
20MG
20MG
30MG
30MG
40MG
40MG
TEVA 2.5MG
5MG
10MG
20MG
30MG
40MG
PRINIVIL
MERCK 2.5MG
LITHIUM CARBONATE
CAPSULE;ORAL
ESKALITH
NOVEN THERAP 300MG
LITHIUM CARBONATE
ABLE 150MG
300MG
300MG
600MG
APOTEX INC 300MG
USL PHARMA 300MG
WATSON LABS 300MG
WEST WARD 600MG
LITHONATE
SOLVAY 300MG
TABLET;ORAL
ESKALITH
JDS PHARMS 300MG
LITHANE
BAYER PHARMS 300MG
LITHIUM CARBONATE
PFIZER 300MG
WEST WARD 300MG
N021130 001
A085755 001
A085753 001
N016680 001
N016680 002
N016680 003
N016680 004
N016807 006
A075903 001
A075999 001
A075903 002
A075999 002
A075903 003
A075999 003
A075903 004
A075999 004
A075903 005
A075999 005
A075903 006
A075999 006
A075783 001
A075783 002
A075783 003
A075783 004
A075783 005
A075783 006
N019558 006
N016860 001
A076823 001
A076121 001
A076823 002
A076823 003
A076795 001
A072542 001
A070407 001
A078763 001
N016782 001
N017971 001
N018833 001
N016834 001
A078715 001
6-195( of 322)
Apr 18, 2000
Jan 25, 1982
Feb 03, 1982
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jul 01, 2002
Jan 28, 1994
Jun 29, 2004
Sep 27, 2001
Jun 29, 2004
Jun 29, 2004
Nov 22, 2004
Feb 01, 1989
Mar 19, 1987
Apr 15, 2008
Jul 18, 1985
Dec 28, 2010
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-196( of 322)
LITHIUM CARBONATE
TABLET;ORAL
LITHOTABS
SOLVAY 300MG N016980 001
TABLET, EXTENDED RELEASE;ORAL
ESKALITH CR
JDS PHARMS 450MG N018152 001 Mar 29, 1982
LITHIUM CARBONATE
ABLE 300MG A076382 001 Apr 21, 2003
BARR 300MG A076170 001 Jun 10, 2002
450MG A076366 001 Aug 21, 2003
LITHIUM CITRATE
SYRUP;ORAL
LITHONATE
SOLVAY EQ 300MG CARBONATE/5ML N017672 001
LOMEFLOXACIN HYDROCHLORIDE
TABLET;ORAL
MAXAQUIN
PHARMACIA EQ 400MG BASE N020013 001 Feb 21, 1992
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
IMODIUM
MCNEIL PED 2MG N017690 001
LOPERAMIDE HYDROCHLORIDE
ROXANE 2MG A073080 001 Nov 27, 1991
SANDOZ 2MG A072993 001 Aug 28, 1992
TEVA 2MG A073122 001 Aug 30, 1991
SOLUTION;ORAL
IMODIUM
JANSSEN PHARMS 1MG/5ML N019037 001 Jul 31, 1984
LOPERAMIDE HYDROCHLORIDE
ALPHARMA US PHARMS 1MG/5ML A073187 001 Sep 15, 1992
DURAMED PHARMS BARR 1MG/5ML A074991 001 Dec 29, 1997
TEVA 1MG/5ML A073478 001 Jun 23, 1995
WATSON LABS 1MG/5ML A073062 001 May 28, 1993
TABLET;ORAL
LOPERAMIDE HYDROCHLORIDE
ABLE 2MG A073528 001 Nov 30, 1993
PERRIGO 2MG A074194 001 Oct 30, 1992
LORACARBEF
CAPSULE;ORAL
LORABID
KING PHARMS 200MG N050668 001 Dec 31, 1991
400MG N050668 002 Apr 05, 1996
FOR SUSPENSION;ORAL
LORABID
KING PHARMS 100MG/5ML N050667 001 Dec 31, 1991
200MG/5ML N050667 002 Dec 31, 1991
LORATADINE
SYRUP;ORAL
CLARITIN HIVES RELIEF
SCHERING PLOUGH 1MG/ML **Federal Register determination N020641 003 Nov 19, 2003
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
LORATADINE
APOTEX INC 1MG/ML A075565 001 Oct 05, 2004
RANBAXY LABS LTD 1MG/ML A076529 001 Aug 20, 2004
TABLET;ORAL
LORATADINE
PERRIGO 10MG N021512 001 Jun 24, 2004
LORATADINE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
LORATADINE AND PSEUDOEPHEDRINE SULFATE
WATSON LABS INC FL 5MG;120MG A076208 001 Jan 28, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
LORAZEPAM
INJECTABLE;INJECTION
LORAZEPAM
AKORN 2MG/ML
BEDFORD 2MG/ML
4MG/ML
DAVA PHARMS INC 2MG/ML
4MG/ML
HIKMA MAPLE 2MG/ML
4MG/ML
HOSPIRA 2MG/ML
2MG/ML
4MG/ML
4MG/ML
MARSAM PHARMS LLC 1MG/0.5ML
2MG/ML
2MG/ML
4MG/ML
4MG/ML
WATSON LABS 2MG/ML
4MG/ML
SOLUTION;ORAL
LORAZEPAM
ROXANE 0.5MG/5ML
TABLET;ORAL
LORAZ
QUANTUM PHARMICS 0.5MG
1MG
2MG
LORAZEPAM
AM THERAP 0.5MG
1MG
2MG
HALSEY 0.5MG
1MG
2MG
MUTUAL PHARM 0.5MG
0.5MG
1MG
1MG
2MG
2MG
PAR PHARM 0.5MG
1MG
2MG
SANDOZ 0.5MG
1MG
2MG
SUPERPHARM 0.5MG
1MG
2MG
USL PHARMA 1MG
2MG
WARNER CHILCOTT 1MG
2MG
WATSON LABS 0.5MG
0.5MG
1MG
2MG
2MG
LOTEPREDNOL ETABONATE
SUSPENSION/DROPS;OPHTHALMIC
LOTEMAX
PHARMOS 0.5%
LOVASTATIN
TABLET;ORAL
MEVACOR
MERCK 10MG
20MG
40MG
6-197( of 322)
A074974 001 Jul 23, 1998
A077076 001 Jul 13, 2005
A077076 002 Jul 13, 2005
A074793 001 Mar 16, 2000
A074793 002 Mar 16, 2000
A074496 001 Sep 28, 1998
A074496 002 Sep 28, 1998
A074280 001 May 27, 1994
A074300 001 Apr 12, 1994
A074280 002 May 27, 1994
A074300 003 Mar 19, 1997
A074551 003 Sep 12, 1996
A074535 001 Sep 12, 1996
A074551 001 Sep 12, 1996
A074535 002 Sep 12, 1996
A074551 002 Sep 12, 1996
A074276 001 Apr 15, 1994
A074276 002 Apr 15, 1994
A074648 001 Mar 18, 1997
A070200 001 Aug 09, 1985
A070201 001 Aug 09, 1985
A070202 001 Aug 09, 1985
A070727 001 Mar 07, 1986
A070728 001 Mar 07, 1986
A070729 001 Mar 07, 1986
A071434 001 Sep 01, 1987
A071435 001 Sep 01, 1987
A071436 001 Sep 01, 1987
A070472 001 Dec 10, 1985
A072553 001 Mar 29, 1991
A070473 001 Dec 10, 1985
A072554 001 Mar 29, 1991
A070474 001 Dec 10, 1985
A072555 001 Mar 29, 1991
A070675 001 Dec 01, 1986
A070676 001 Dec 01, 1986
A070677 001 Dec 01, 1986
A071193 001 Apr 15, 1988
A071194 001 Apr 15, 1988
A071195 001 Apr 15, 1988
A071245 001 Feb 09, 1987
A071246 001 Feb 09, 1987
A071247 001 Feb 09, 1987
A070539 001 Dec 22, 1986
A070540 001 Dec 22, 1986
A071038 001 Jan 12, 1988
A071039 001 Jan 12, 1988
A071086 001 Mar 23, 1987
A071117 001 Jul 24, 1986
A071087 001 Mar 23, 1987
A071088 001 Mar 23, 1987
A071110 001 Jul 24, 1986
N020841 001 Mar 09, 1998
N019643 002 Mar 28, 1991
N019643 003 Aug 31, 1987
N019643 004 Dec 14, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
LOVASTATIN
TABLET, EXTENDED RELEASE;ORAL
ALTOPREV
ANDRX LABS LLC
LOXAPINE HYDROCHLORIDE
CONCENTRATE;ORAL
LOXITANE C
WATSON LABS
INJECTABLE;INJECTION
LOXITANE IM
WATSON LABS
LOXAPINE SUCCINATE
CAPSULE;ORAL
LOXITANE
WATSON LABS
TABLET;ORAL
LOXITANE
WATSON LABS
LUTROPIN ALFA
INJECTABLE;SUBCUTANEOUS
LUVERIS
EMD SERONO
LYPRESSIN
SOLUTION;NASAL
DIAPID
NOVARTIS
10MG
EQ 25MG BASE/ML
EQ 50MG BASE/ML
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
75 IU/VIAL
0.185MG/ML
6-198( of 322)
N021316 001 Jun 26, 2002
N017658 001
N018039 001
N017525 001
N017525 002
N017525 003
N017525 004
N017525 006
N017525 007
N017525 008
N021322 001 Oct 08, 2004
N016755 001
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM
CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE;INJECTION
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER
B BRAUN 30MG/100ML;37MG/100ML;0.82MG/100ML;370M N019006 001 Apr 04, 1984
G/100ML;530MG/100ML;500MG/100ML;12MG/10
0ML
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
INJECTABLE;INJECTION
ISOLYTE S IN PLASTIC CONTAINER
B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG
/100ML;500MG/100ML
SOLUTION;IRRIGATION
N018252 001
PHYSIOSOL IN PLASTIC CONTAINER
HOSPIRA INC 14MG/100ML;37MG/100ML;222MG/100ML;526MG
/100ML;502MG/100ML
PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER
N018406 001
HOSPIRA INC 30MG/100ML;37MG/100ML;222MG/100ML;526MG
/100ML;502MG/100ML
SYNOVALYTE IN PLASTIC CONTAINER
N018406 002 Jul 08, 1982
BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG
/100ML;502MG/100ML
N019326 001 Jan 25, 1985
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE
TABLET;ORAL
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
SANTARUS 343MG;20MG;750MG N022456 001 Dec 04, 2009
343MG;40MG;750MG N022456 002 Dec 04, 2009
TABLET, CHEWABLE;ORAL
ZEGERID
SANTARUS 700MG;20MG;600MG N021850 001 Mar 24, 2006
700MG;40MG;600MG N021850 002 Mar 24, 2006
MANGAFODIPIR TRISODIUM
INJECTABLE;INJECTION
TESLASCAN
GE HEALTHCARE 37.9MG/ML N020652 001 Nov 26, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-199( of 322)
MANGANESE CHLORIDE TETRAHYDRATE
FOR SOLUTION;ORAL
LUMENHANCE
BRACCO 3.49MG/GM N020686 001 Dec 19, 1997
MANGANESE SULFATE
INJECTABLE;INJECTION
MANGANESE SULFATE
ABRAXIS PHARM EQ 0.1MG MANGANESE/ML N019228 001 May 05, 1987
MANNITOL
INJECTABLE;INJECTION
MANNITOL 10%
HOSPIRA 10GM/100ML N016269 002
MILES 10GM/100ML N016472 002
MANNITOL 15%
HOSPIRA 15GM/100ML N016269 003
MILES 15GM/100ML N016472 005
MANNITOL 20%
B BRAUN 20GM/100ML N014738 001
HOSPIRA 20GM/100ML N016269 004
MILES 20GM/100ML N016472 004
MANNITOL 25%
ABRAXIS PHARM 12.5GM/50ML A086754 001
ASTRAZENECA 12.5GM/50ML A089239 001 May 06, 1987
12.5GM/50ML A089240 001 May 06, 1987
HOSPIRA 12.5GM/50ML N016269 005
MERCK 12.5GM/50ML N005620 001
WATSON LABS 12.5GM/50ML A087460 001 Jun 27, 1983
MANNITOL 5%
HOSPIRA 5GM/100ML N016269 001
SOLUTION;IRRIGATION
RESECTISOL
B BRAUN 5GM/100ML N016704 002
MANNITOL; SORBITOL
SOLUTION;IRRIGATION
SORBITOL-MANNITOL
HOSPIRA 540MG/100ML;2.7GM/100ML A080224 001
SORBITOL-MANNITOL IN PLASTIC CONTAINER
HOSPIRA 540MG/100ML;2.7GM/100ML N017636 001
MAPROTILINE HYDROCHLORIDE
TABLET;ORAL
LUDIOMIL
NOVARTIS 25MG N017543 001
50MG N017543 002
75MG N017543 003 Sep 30, 1982
MAPROTILINE HYDROCHLORIDE
AM THERAP 25MG A072129 001 Jan 14, 1988
50MG A072130 001 Jan 14, 1988
75MG A072131 001 Jan 14, 1988
WATSON LABS 25MG A071943 001 Dec 30, 1987
25MG A072162 001 Jun 01, 1988
50MG A071944 001 Dec 30, 1987
50MG A072163 001 Jun 01, 1988
75MG A071945 001 Dec 30, 1987
75MG A072164 001 Jun 01, 1988
MASOPROCOL
CREAM;TOPICAL
ACTINEX
UNIV AZ CANCER CTR 10% N019940 001 Sep 04, 1992
MAZINDOL
TABLET;ORAL
MAZANOR
WYETH AYERST 1MG N017980 002
2MG N017980 001
SANOREX
NOVARTIS 1MG **Federal Register determination N017247 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
2MG **Federal Register determination N017247 002
that product was not discontinued or
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-200( of 322)
MAZINDOL
TABLET;ORAL
SANOREX
withdrawn for safety or efficacy
reasons**
MEBENDAZOLE
TABLET, CHEWABLE;ORAL
VERMOX
JANSSEN PHARMS 100MG N017481 001
MEBUTAMATE
TABLET;ORAL
DORMATE
MEDPOINTE PHARM HLC 600MG N017374 001
MECAMYLAMINE HYDROCHLORIDE
TABLET;ORAL
INVERSINE
TARGACEPT 2.5MG **Federal Register determination N010251 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
MECASERMIN RINFABATE RECOMBINANT
INJECTABLE;SUBCUTANEOUS
IPLEX
INSMED 36MG/0.6ML N021884 001 Dec 12, 2005
MECLIZINE HYDROCHLORIDE
TABLET;ORAL
MECLIZINE HYDROCHLORIDE
ABC HOLDING 12.5MG A085253 001
25MG A085252 001
ANABOLIC 25MG A085891 001
BUNDY 12.5MG A084382 001
25MG A084872 001
IVAX SUB TEVA PHARMS 12.5MG A083784 001
12.5MG A084975 001
25MG A084657 001
KV PHARM 12.5MG A085524 001
25MG A085523 001
PLIVA
SUPERPHARM
UDL
VANGARD
WATSON LABS
12.5MG
25MG
12.5MG
25MG
12.5MG
25MG
12.5MG
25MG
12.5MG
A088732 001
A088734 001
A089113 001
A089114 001
A088256 001
A088257 001
A087877 001
A087620 001
A085195 001
Dec 11, 1985
Dec 11, 1985
Aug 20, 1985
Aug 20, 1985
Jun 13, 1983
Jun 13, 1983
Apr 20, 1982
Jan 04, 1982
12.5MG A085269 001
TABLET, CHEWABLE;ORAL
ANTIVERT
CITRON PHARMA LLC 25MG N010721 005
MECLIZINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 25MG A084976 001
NEXGEN PHARMA INC 25MG A086392 001
PLIVA 25MG A088733 001 Dec 11, 1985
MECLOCYCLINE SULFOSALICYLATE
CREAM;TOPICAL
MECLAN
JOHNSON AND JOHNSON 1% N050518 001
MECLOFENAMATE SODIUM
CAPSULE;ORAL
MECLODIUM
QUANTUM PHARMICS
MECLOFENAMATE SODIUM
EQ 50MG BASE
EQ 100MG BASE
A071380 001
A071381 001
Jul 14, 1987
Jul 14, 1987
AM THERAP
BARR
PAR PHARM
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
A071362 001
A071363 001
A072848 001
A072809 001
A072077 001
Feb 10, 1987
Feb 10, 1987
Mar 20, 1989
Mar 20, 1989
Mar 10, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-201( of 322)
MECLOFENAMATE SODIUM
CAPSULE;ORAL
MECLOFENAMATE SODIUM
EQ 100MG BASE A072078 001 Mar 10, 1988
SANDOZ EQ 50MG BASE A072262 001 Nov 29, 1988
EQ 100MG BASE A072263 001 Nov 29, 1988
USL PHARMA EQ 50MG BASE A071007 001 Mar 25, 1988
EQ 100MG BASE A071008 001 Mar 25, 1988
VITARINE EQ 50MG BASE A071710 001 Jun 15, 1988
EQ 100MG BASE A071684 001 Jun 15, 1988
WATSON LABS EQ 50MG BASE A070400 001 Nov 25, 1986
EQ 50MG BASE A071468 001 Apr 15, 1987
EQ 50MG BASE A071640 001 Aug 11, 1987
EQ 100MG BASE A070401 001 Nov 25, 1986
EQ 100MG BASE A071469 001 Apr 15, 1987
EQ 100MG BASE A071641 001 Aug 11, 1987
MECLOMEN
PARKE DAVIS EQ 50MG BASE N018006 001
EQ 100MG BASE N018006 002
MEDROXYPROGESTERONE ACETATE
INJECTABLE;INJECTION
DEPO-PROVERA
PHARMACIA AND UPJOHN 100MG/ML **Federal Register N012541 002
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
MEDROXYPROGESTERONE ACETATE
TEVA PHARMS USA 150MG/ML A076552 001 Oct 27, 2004
TABLET;ORAL
AMEN
AMARIN PHARMS 10MG A083242 001
CURRETAB
SOLVAY 10MG A085686 001
CYCRIN
ESI 2.5MG A081239 001 Oct 30, 1992
5MG A081240 001 Oct 30, 1992
10MG A089386 001 Sep 09, 1987
MEDROXYPROGESTERONE ACETATE
DURAMED PHARMS BARR 2.5MG A040311 001 Dec 01, 1999
5MG A040311 002 Dec 01, 1999
10MG A040311 003 Dec 01, 1999
MEDRYSONE
SUSPENSION;OPHTHALMIC
HMS
ALLERGAN 1% N016624 003
MEFLOQUINE HYDROCHLORIDE
TABLET;ORAL
LARIAM
ROCHE 250MG N019591 001 May 02, 1989
MEFLOQUINE HYDROCHLORIDE
US ARMY WALTER REED 250MG N019578 001 May 02, 1989
WEST WARD PHARM CORP 250MG A077699 001 Apr 21, 2010
MEGESTROL ACETATE
SUSPENSION;ORAL
MEGESTROL ACETATE
APOTEX INC 40MG/ML A077404 001 Feb 16, 2006
TABLET;ORAL
MEGACE
BRISTOL MYERS SQUIBB 20MG N016979 001
40MG N016979 002
MEGESTROL ACETATE
TEVA 40MG A074745 001 Feb 27, 1998
USL PHARMA 20MG A070646 001 Oct 02, 1987
40MG A070647 001 Oct 02, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-202( of 322)
MELOXICAM
TABLET;ORAL
MELOXICAM
COREPHARMA 7.5MG A077930 001 Jul 19, 2006
15MG A077930 002 Jul 19, 2006
CR DOUBLE CRANE 7.5MG A078039 001 Dec 14, 2006
15MG A078039 002 Dec 14, 2006
MUTUAL PHARM 7.5MG A077935 001 Jul 19, 2006
15MG A077935 002 Jul 19, 2006
MYLAN 7.5MG A077934 001 Jul 20, 2006
15MG A077934 002 Jul 20, 2006
ROXANE 7.5MG A077925 001 Jul 19, 2006
15MG A077925 002 Jul 19, 2006
YABAO BIOPHARMS 7.5MG A077933 001 Jul 19, 2006
15MG A077933 002 Jul 19, 2006
MELPHALAN HYDROCHLORIDE
INJECTABLE;INJECTION
MELPHALAN HYDROCHLORIDE
MYLAN INSTITUTIONAL EQ 50MG BASE/VIAL A090299 001 Oct 27, 2009
MEMANTINE HYDROCHLORIDE
TABLET;ORAL
MEMANTINE
SUN PHARMA GLOBAL 5MG A090058 001 May 05, 2010
10MG A090058 002 May 05, 2010
MEMANTINE HYDROCHLORIDE
DR REDDYS LABS LTD 5MG A090048 001 Apr 14, 2010
10MG A090048 002 Apr 14, 2010
ORCHID HLTHCARE 5MG A090044 001 Mar 12, 2012
10MG A090044 002 Mar 12, 2012
TEVA PHARMS 5MG A090052 001 Oct 25, 2011
10MG A090052 002 Oct 25, 2011
MENADIOL SODIUM DIPHOSPHATE
INJECTABLE;INJECTION
KAPPADIONE
LILLY 10MG/ML N005725 001
SYNKAYVITE
ROCHE 5MG/ML N003718 004
10MG/ML N003718 006
37.5MG/ML N003718 008
TABLET;ORAL
SYNKAYVITE
ROCHE 5MG N003718 010
MENADIONE
TABLET;ORAL
MENADIONE
LILLY 5MG N002139 003
MENOTROPINS (FSH;LH)
INJECTABLE;INJECTION
HUMEGON
ORGANON USA INC 75 IU/VIAL;75 IU/VIAL N020328 001 Sep 01, 1994
150 IU/VIAL;150 IU/VIAL N020328 002 Sep 01, 1994
MENOTROPINS
FERRING 75 IU/VIAL;75 IU/VIAL A073598 001 Jan 30, 1997
150 IU/VIAL;150 IU/VIAL A073599 001 Jan 30, 1997
PERGONAL
SERONO 75 IU/AMP;75 IU/AMP N017646 001
150 IU/AMP;150 IU/AMP N017646 002 May 20, 1985
REPRONEX
FERRING 150 IU/VIAL;150 IU/VIAL N021047 002 Aug 27, 1999
MEPENZOLATE BROMIDE
SOLUTION;ORAL
CANTIL
SANOFI AVENTIS US 25MG/5ML N010679 004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-203( of 322)
MEPERIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
DEMEROL
SANOFI AVENTIS US 25MG/ML N005010 007
50MG/ML N005010 002
75MG/ML N005010 009
100MG/ML N005010 003
MEPERIDINE HYDROCHLORIDE
ABBOTT 25MG/ML A080388 001
50MG/ML A080385 001
50MG/ML A080387 001
75MG/ML A080389 001
100MG/ML A080386 001
ASTRAZENECA 25MG/ML A089781 001 Mar 31, 1989
50MG/ML A089782 001 Mar 31, 1989
50MG/ML A089783 001 Mar 31, 1989
50MG/ML A089784 001 Mar 31, 1989
75MG/ML A089785 001 Mar 31, 1989
100MG/ML A089786 001 Mar 31, 1989
100MG/ML A089787 001 Mar 31, 1989
100MG/ML A089788 001 Mar 31, 1989
BAXTER HLTHCARE 25MG/ML A088279 001 Jun 15, 1984
50MG/ML A088280 001 Jun 15, 1984
75MG/ML A088281 001 Jun 15, 1984
100MG/ML A088282 001 Jun 15, 1984
INTL MEDICATION 10MG/ML A086332 001
PARKE DAVIS 50MG/ML A080364 002
75MG/ML A080364 003
100MG/ML A080364 001
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
HOSPIRA 10MG/ML A040305 001 Mar 10, 1999
MALLINCKRODT 10MG/ML A040163 001 May 12, 1997
SYRUP;ORAL
DEMEROL
SANOFI AVENTIS US 50MG/5ML N005010 005
TABLET;ORAL
MEPERIDINE HYDROCHLORIDE
DURAMED PHARMS BARR 50MG A040318 001 Oct 05, 1999
100MG A040318 002 Oct 05, 1999
MUTUAL PHARM 50MG A080448 001
100MG A080448 002
WYETH AYERST 50MG A080454 001
MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
MEPERGAN
BAXTER HLTHCARE CORP 25MG/ML;25MG/ML N011730 001
MEPHENTERMINE SULFATE
INJECTABLE;INJECTION
WYAMINE SULFATE
BAXTER HLTHCARE CORP EQ 15MG BASE/ML N008248 002
EQ 30MG BASE/ML N008248 001
MEPHENYTOIN
TABLET;ORAL
MESANTOIN
NOVARTIS 100MG **Federal Register determination N006008 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
MEPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
ARESTOCAINE HYDROCHLORIDE
SOLVAY 3% A084777 002 Apr 18, 1982
CARBOCAINE
EASTMAN KODAK 3% N012125 003
MEPIVACAINE HYDROCHLORIDE
GRAHAM CHEM 3% A083559 001
INTL MEDICATION 1% A087509 001 Oct 05, 1982
POLOCAINE
DENTSPLY PHARM 3% A088653 001 Aug 21, 1984
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
6-204( of 322)
N016053 002
N012455 002
N011284 001
N011284 002
A084030 001
A080380 001
A080380 002
N010028 005
N010028 004
N016069 001
A084230 001
N015426 002
N015426 001
N016928 003
A084329 001
N014322 002
N014322 001
N015438 001
N015438 002
A084181 001
A084153 001
N014882 002
N014882 001
A086299 001
A089538 001 Nov 25, 1987
N015072 002
N014368 004
N014368 002
A080699 001
A080699 002
A083618 001
A084220 001
A084589 001
A084744 001
A084744 002
A084546 001
A084547 001
A084438 001
A084804 001
A084804 002
N014601 001
A084332 001
N014547 002
A080655 001
N014547 001
A083343 001
A084435 001
N014474 002
N014474 004
A083494 001
A200998 001 May 23, 2011
A200998 002 May 23, 2011
A087825 001 Mar 18, 1982
A087826 001 Mar 18, 1982
N015139 006
N015139 005
A088011 001 Jul 14, 1982
A085720 001
MEPREDNISONE
TABLET;ORAL
BETAPAR
SCHERING
MEPROBAMATE
CAPSULE;ORAL
EQUANIL
WYETH AYERST
CAPSULE, EXTENDED RELEASE;ORAL
DISCONTINUED DRUG PRODUCT LIST
4MG
400MG
MEPROSPAN
MEDPOINTE PHARM HLC
TABLET;ORAL
AMOSENE
FERNDALE LABS
BAMATE
ALRA
EQUANIL
WYETH AYERST
MEPRIAM
TEVA
MEPROBAMATE
BARR
ELKINS SINN
HEATHER
IMPAX LABS
IVAX SUB TEVA PHARMS
IVC INDS
LANNETT
LEDERLE
LEE KM
MALLARD
MK LABS
MUTUAL PHARM
MYLAN
NEXGEN PHARMA INC
PARKE DAVIS
PERRIGO
PHARMAVITE
PUREPAC PHARM
PVT FORM
ROXANE
SANDOZ
SCHERER LABS
SOLVAY
STANLABS PHARM
TABLICAPS
TARO
USL PHARMA
VALEANT PHARM INTL
VANGARD
WATSON LABS
200MG
400MG
400MG
200MG
400MG
200MG
400MG
400MG
600MG
200MG
400MG
400MG
600MG
200MG
400MG
200MG
400MG
600MG
400MG
200MG
400MG
400MG
400MG
400MG
200MG
400MG
200MG
400MG
400MG
200MG
400MG
200MG
400MG
200MG
400MG
400MG
200MG
400MG
400MG
600MG
200MG
400MG
400MG
400MG
200MG
200MG
400MG
400MG
200MG
400MG
200MG
400MG
200MG
400MG
400MG
200MG
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
MEPROBAMATE
TABLET;ORAL
MEPROBAMATE
400MG
600MG
600MG
WEST WARD 200MG
400MG
WHITEWORTH TOWN PLSN 200MG
400MG
MILTOWN
MEDPOINTE PHARM HLC 200MG
400MG
600MG
NEURAMATE
HALSEY 200MG
400MG
TRANMEP
SOLVAY 400MG
400MG
MEQUINOL; TRETINOIN
SOLUTION;TOPICAL
SOLAGE
AQUA PHARMS 2%;0.01%
MERSALYL SODIUM; THEOPHYLLINE
INJECTABLE;INJECTION
MERSALYL-THEOPHYLLINE
WATSON LABS 100MG/ML;50MG/ML
MESALAMINE
SUPPOSITORY;RECTAL
CANASA
APTALIS PHARMA US 500MG
ROWASA
MEDA PHARMS 500MG
MESORIDAZINE BESYLATE
CONCENTRATE;ORAL
SERENTIL
NOVARTIS EQ 25MG BASE/ML
INJECTABLE;INJECTION
SERENTIL
NOVARTIS EQ 25MG BASE/ML
TABLET;ORAL
SERENTIL
NOVARTIS EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
MESTRANOL; NORETHINDRONE
TABLET;ORAL-20
NORINYL
WATSON LABS 0.1MG;2MG
TABLET;ORAL-21
NORETHIN 1/50M-21
WATSON LABS 0.05MG;1MG
NORETHINDRONE AND MESTRANOL
WATSON LABS 0.05MG;1MG
NORINYL 1+50 21-DAY
WATSON LABS 0.05MG;1MG
NORINYL 1+80 21-DAY
GD SEARLE LLC 0.08MG;1MG
ORTHO-NOVUM 1/50 21
ORTHO MCNEIL PHARM 0.05MG;1MG
ORTHO-NOVUM 1/80 21
ORTHO MCNEIL PHARM 0.08MG;1MG
ORTHO-NOVUM 10-21
ORTHO MCNEIL PHARM 0.06MG;10MG
ORTHO-NOVUM 2-21
ORTHO MCNEIL PHARM 0.1MG;2MG
6-205( of 322)
A085721 001
A084274 001
A085719 001
N015417 003
N015417 002
A083830 001
A083442 001
N009698 004
N009698 002
A083919 001
N014359 002
N014359 001
A084369 001
N016249 001
N020922 001 Dec 10, 1999
A084875 001
N021252 001 Jan 05, 2001
N019919 001 Dec 18, 1990
N016997 001
N016775 001
N016774 001
N016774 002
N016774 003
N016774 004
N013625 004
A071539 001 Apr 12, 1988
A070758 001 Jul 01, 1988
N013625 002
N016724 001
N012728 004
N016715 001
N012728 001
N012728 005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-206( of 322)
MESTRANOL; NORETHINDRONE
TABLET;ORAL-28
NORETHIN 1/50M-28
WATSON LABS 0.05MG;1MG A071540 001 Apr 12, 1988
NORETHINDRONE AND MESTRANOL
WATSON LABS 0.05MG;1MG A070759 001 Jul 01, 1988
NORINYL 1+80 28-DAY
GD SEARLE LLC 0.08MG;1MG N016725 001
ORTHO-NOVUM 1/50 28
ORTHO MCNEIL JANSSEN 0.05MG;1MG N016709 001
ORTHO-NOVUM 1/80 28
ORTHO MCNEIL PHARM 0.08MG;1MG N016715 002
MESTRANOL; NORETHYNODREL
TABLET;ORAL
ENOVID
GD SEARLE LLC 0.075MG;5MG N010976 008
0.15MG;9.85MG N010976 005
TABLET;ORAL-20
ENOVID
GD SEARLE LLC 0.075MG;5MG N010976 004
ENOVID-E
GD SEARLE LLC 0.1MG;2.5MG N010976 006
TABLET;ORAL-21
ENOVID-E 21
GD SEARLE LLC 0.1MG;2.5MG N010976 007
METAPROTERENOL SULFATE
AEROSOL, METERED;INHALATION
ALUPENT
BOEHRINGER INGELHEIM 0.65MG/INH N016402 001
SOLUTION;INHALATION
ALUPENT
BOEHRINGER INGELHEIM 0.4% N018761 002 Oct 10, 1986
0.6% N018761 001 Jun 30, 1983
5% N017659 001
METAPROTERENOL SULFATE
APOTEX INC 0.4% A075402 001 Feb 28, 2001
0.6% A075403 001 Feb 28, 2001
ASTRAZENECA 0.4% A071275 001 Jul 27, 1988
0.6% A071018 001 Jul 27, 1988
DEY 0.33% A071806 001 Aug 05, 1988
0.5% A071805 001 Aug 05, 1988
5% A070805 001 Aug 17, 1987
NEPHRON 0.4% A071855 001 Jul 14, 1988
0.6% A071726 001 Jul 14, 1988
WOCKHARDT 5% A072190 001 Jun 07, 1988
PROMETA
MURO 5% A073340 001 Mar 30, 1992
SYRUP;ORAL
ALUPENT
BOEHRINGER INGELHEIM 10MG/5ML N017571 001
METAPROTERENOL SULFATE
APOTEX INC 10MG/5ML A075235 001 Jan 27, 2000
MORTON GROVE 10MG/5ML A071656 001 Oct 13, 1987
TEVA 10MG/5ML A072761 001 Feb 27, 1992
TEVA PHARMS 10MG/5ML A073034 001 Aug 30, 1991
WOCKHARDT 10MG/5ML A074702 001 Mar 24, 1997
PROMETA
MURO 10MG/5ML A072023 001 Sep 15, 1988
TABLET;ORAL
ALUPENT
BOEHRINGER INGELHEIM 10MG N015874 002
20MG N015874 001
METAPROTERENOL SULFATE
AM THERAP 10MG A072054 001 Jun 23, 1988
20MG A072055 001 Jun 23, 1988
TEVA 10MG A072519 001 Mar 30, 1990
20MG A072520 001 Mar 30, 1990
USL PHARMA 10MG A071013 001 Jan 25, 1988
20MG A071014 001 Jan 25, 1988
WATSON LABS 10MG A073013 001 Jan 31, 1991
20MG A072795 001 Jan 31, 1991
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-207( of 322)
METARAMINOL BITARTRATE
INJECTABLE;INJECTION
ARAMINE
MERCK EQ 10MG BASE/ML N009509 002 Dec 22, 1987
METARAMINOL BITARTRATE
ABRAXIS PHARM EQ 10MG BASE/ML A080431 001
ELKINS SINN EQ 10MG BASE/ML A083363 001
GD SEARLE LLC EQ 10MG BASE/ML A086418 001
EQ 20MG BASE/ML A086418 002
METAXALONE
TABLET;ORAL
SKELAXIN
KING PHARMS 400MG N013217 001
METFORMIN HYDROCHLORIDE
TABLET;ORAL
GLUCOPHAGE
BRISTOL MYERS SQUIBB 625MG N020357 003 Nov 05, 1998
750MG N020357 004 Nov 05, 1998
METFORMIN HYDROCHLORIDE
BARR 1GM A075971 003 Jan 25, 2002
500MG A075971 001 Jan 25, 2002
850MG A075971 002 Jan 25, 2002
IPCA LABS LTD 1GM A078422 003 Aug 06, 2007
500MG A078422 001 Aug 06, 2007
850MG A078422 002 Aug 06, 2007
IVAX SUB TEVA PHARMS 1GM A075975 003 Jan 24, 2002
500MG A075975 001 Jan 24, 2002
625MG A075975 004 Jan 24, 2002
750MG A075975 005 Jan 24, 2002
850MG A075975 002 Jan 24, 2002
TEVA 1GM A076328 003 Dec 16, 2002
500MG A076328 001 Dec 16, 2002
850MG A076328 002 Dec 16, 2002
TABLET, EXTENDED RELEASE;ORAL
METFORMIN HYDROCHLORIDE
ACTAVIS ELIZABETH 500MG A076450 001 Oct 01, 2004
750MG A076878 001 Apr 13, 2005
BARR 500MG A076496 001 Nov 25, 2005
IVAX SUB TEVA PHARMS 500MG A076545 001 Dec 01, 2003
MUTUAL PHARM 500MG A077124 001 Dec 21, 2005
RANBAXY LABS LTD 500MG A076413 001 Jun 18, 2004
750MG A077211 001 Jun 29, 2005
SANDOZ 500MG A076223 001 Dec 14, 2004
TORRENT PHARMS LTD 750MG A079226 001 Feb 18, 2010
WATSON LABS INC 500MG A076818 001 Dec 14, 2004
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
TABLET;ORAL
AVANDAMET
SB PHARMCO 500MG;EQ 1MG BASE N021410 001 Oct 10, 2002
METHACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
RONDOMYCIN
MEDPOINTE PHARM HLC EQ 140MG BASE A060641 001
EQ 280MG BASE A060641 002
SYRUP;ORAL
RONDOMYCIN
MEDPOINTE PHARM HLC EQ 70MG BASE/5ML A060641 003
METHADONE HYDROCHLORIDE
SYRUP;ORAL
DOLOPHINE HYDROCHLORIDE
ROXANE 10MG/30ML N006134 004
TABLET;ORAL
METHADONE HYDROCHLORIDE
ROXANE 5MG A088108 001 Mar 08, 1983
10MG A088109 001 Mar 08, 1983
40MG A074081 001 Apr 28, 1995
SANDOZ 5MG A040241 001 May 29, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
METHADONE HYDROCHLORIDE
TABLET, DISPERSIBLE;ORAL
WESTADONE
SANDOZ 2.5MG
TABLET, EFFERVESCENT;ORAL
WESTADONE
SANDOZ 5MG
10MG
40MG
METHAMPHETAMINE HYDROCHLORIDE
TABLET;ORAL
METHAMPEX
TEVA 10MG
METHAMPHETAMINE HYDROCHLORIDE
ABLE 5MG
REXAR 5MG
10MG
TEVA 5MG
TABLET, EXTENDED RELEASE;ORAL
DESOXYN
RECORDATI RARE 5MG
10MG
15MG
METHANTHELINE BROMIDE
TABLET;ORAL
BANTHINE
SHIRE 50MG
METHARBITAL
TABLET;ORAL
GEMONIL
ABBVIE 100MG
METHAZOLAMIDE
TABLET;ORAL
METHAZOLAMIDE
APPLIED ANAL 25MG
50MG
SANDOZ 25MG
50MG
NEPTAZANE
LEDERLE 25MG
50MG
METHDILAZINE
TABLET, CHEWABLE;ORAL
TACARYL
WESTWOOD SQUIBB 3.6MG
METHDILAZINE HYDROCHLORIDE
SYRUP;ORAL
METHDILAZINE HYDROCHLORIDE
ALPHARMA US PHARMS 4MG/5ML
TACARYL
WESTWOOD SQUIBB 4MG/5ML
TABLET;ORAL
TACARYL
WESTWOOD SQUIBB 8MG
METHICILLIN SODIUM
INJECTABLE;INJECTION
STAPHCILLIN
APOTHECON EQ 3.6GM BASE/VIAL
EQ 3.6GM BASE/VIAL
EQ 5.4GM BASE/VIAL
EQ 5.4GM BASE/VIAL
EQ 900MG BASE/VIAL
EQ 900MG BASE/VIAL
6-208( of 322)
N017108 001
N017108 002
N017108 003
N017108 004
A083889 001
A040529 001 Feb 25, 2004
A084931 001
A084931 002
A086359 001
N005378 004
N005378 003
N005378 005
N007390 001
N008322 001
A040011 001 Jul 17, 1997
A040011 002 Jul 17, 1997
A040102 001 Aug 28, 1996
A040102 002 Aug 28, 1996
N011721 002 Nov 25, 1991
N011721 001
N011950 009
A087122 001
N011950 007
N011950 006
A061449 002
N050117 002
A061449 003
N050117 003
A061449 001
N050117 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
METHIMAZOLE
TABLET;ORAL
METHIMAZOLE
CEDAR PHARMS 15MG
20MG
MYLAN 20MG
TAPAZOLE
KING PHARMS 5MG
10MG
METHIXENE HYDROCHLORIDE
TABLET;ORAL
TREST
NOVARTIS 1MG
METHOCARBAMOL
INJECTABLE;INJECTION
METHOCARBAMOL
MARSAM PHARMS LLC 100MG/ML
WATSON LABS 100MG/ML
TABLET;ORAL
DELAXIN
FERNDALE LABS 500MG
FORBAXIN
FOREST LABS 750MG
METHOCARBAMOL
ABLE 500MG
750MG
AM THERAP 500MG
750MG
ASCOT 500MG
750MG
CLONMEL HLTHCARE 500MG
750MG
HEATHER 500MG
750MG
IMPAX LABS 500MG
750MG
INWOOD LABS 500MG
IVAX SUB TEVA PHARMS 500MG
750MG
KV PHARM 500MG
750MG
MUTUAL PHARM 500MG
750MG
MYLAN 500MG
750MG
NYLOS 750MG
PIONEER PHARMS 500MG
750MG
PURACAP PHARM 500MG
750MG
PUREPAC PHARM 500MG
750MG
ROXANE 500MG
750MG
SANDOZ 500MG
750MG
SOLVAY 500MG
750MG
SUPERPHARM 500MG
750MG
TABLICAPS 500MG
UPSHER SMITH 500MG
750MG
WATSON LABS 500MG
750MG
6-209( of 322)
A040619 003 Jul 12, 2005
A040547 004 Feb 18, 2005
A040350 003 Jun 07, 2001
N007517 002
N007517 004
N013420 001
A089849 001 Dec 27, 1991
A086459 001
A085454 001
A085136 001
A040413 001 Mar 17, 2003
A040413 002 Mar 17, 2003
A089417 001 Feb 11, 1987
A089418 001 Feb 11, 1987
A087660 001 Oct 27, 1982
A087661 001 Oct 27, 1982
A085961 001
A085963 001
A084675 001
A084924 001
A084927 001
A084928 001
A085137 001
A084648 001
A084649 001
A085660 001
A085658 001
A084488 001
A084486 001
A084259 001
A084323 001
A085033 001
A088731 001 Dec 13, 1985
A089082 001 Dec 13, 1985
A084231 002
A084471 001
A085718 001
A085718 002
A088646 001 Feb 29, 1984
A088647 001 Feb 29, 1984
A087283 001
A087282 001
A084448 001
A084449 001
A087589 001 Jan 22, 1982
A087590 001 Jan 22, 1982
A084846 001
A087453 001
A087454 001
A083605 001
A083605 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-210( of 322)
METHOHEXITAL SODIUM
INJECTABLE;INJECTION
BREVITAL SODIUM
JHP PHARMS 5GM/VIAL N011559 003
METHOTREXATE SODIUM
INJECTABLE;INJECTION
ABITREXATE
ABIC EQ 25MG BASE/ML A089161 001 Mar 10, 1987
EQ 50MG BASE/VIAL A089354 001 Jul 17, 1987
EQ 100MG BASE/VIAL A089355 001 Jul 17, 1987
EQ 250MG BASE/VIAL A089356 001 Jul 17, 1987
FOLEX
PHARMACIA AND UPJOHN EQ 25MG BASE/VIAL A087695 001 Apr 08, 1983
EQ 50MG BASE/VIAL A087695 002 Apr 08, 1983
EQ 100MG BASE/VIAL A087695 003 Apr 08, 1983
EQ 250MG BASE/VIAL A088954 001 Oct 24, 1985
FOLEX PFS
PHARMACIA AND UPJOHN EQ 25MG BASE/ML A081242 001 Aug 23, 1991
EQ 25MG BASE/ML A089180 001 Jan 03, 1986
METHOTREXATE LPF
HOSPIRA EQ 25MG BASE/ML N011719 007 Mar 31, 1982
METHOTREXATE PRESERVATIVE FREE
FRESENIUS KABI USA EQ 25MG BASE/ML A040265 001 Feb 26, 1999
HOSPIRA EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) N011719 011 Apr 13, 2005
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) N011719 014 Apr 13, 2005
EQ 500MG BASE/20ML (EQ 25MG BASE/ML) N011719 013 Apr 13, 2005
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
METHOTREXATE SODIUM
ABRAXIS PHARM EQ 2.5MG BASE/ML A089323 001 Jun 13, 1986
EQ 20MG BASE/VIAL A088935 001 Oct 11, 1985
EQ 25MG BASE/ML A089263 001 Jun 13, 1986
EQ 25MG BASE/ML A089322 001 Jun 13, 1986
EQ 50MG BASE/VIAL A088936 001 Oct 11, 1985
EQ 100MG BASE/VIAL A088937 001 Oct 11, 1985
HOSPIRA EQ 2.5MG BASE/ML N011719 004
EQ 20MG BASE/VIAL N011719 001
EQ 25MG BASE/ML N011719 005
EQ 50MG BASE/VIAL N011719 003
EQ 100MG BASE/VIAL N011719 006
NORBROOK EQ 25MG BASE/ML A088648 001 May 09, 1986
PHARMACHEMIE USA EQ 25MG BASE/ML A089158 001 Jul 08, 1988
METHOTREXATE SODIUM PRESERVATIVE FREE
HOSPIRA EQ 1GM BASE/VIAL N011719 009 Apr 07, 1988
MEXATE
BRISTOL EQ 20MG BASE/VIAL A086358 001
EQ 50MG BASE/VIAL A086358 002
EQ 100MG BASE/VIAL A086358 003
EQ 250MG BASE/VIAL A086358 004
MEXATE-AQ
BRISTOL MYERS EQ 25MG BASE/ML A088760 001 Feb 14, 1985
MEXATE-AQ PRESERVED
BRISTOL MYERS SQUIBB EQ 25MG BASE/ML A089887 001 Apr 14, 1989
TABLET;ORAL
METHOTREXATE SODIUM
DURAMED PHARMS BARR EQ 2.5MG BASE A040233 001 Jun 17, 1999
METHOXAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
VASOXYL
GLAXOSMITHKLINE 10MG/ML N006772 002
20MG/ML N006772 001
METHOXSALEN
CAPSULE;ORAL
METHOXSALEN
SANDOZ 10MG A087781 001 Jun 08, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-211( of 322)
METHSCOPOLAMINE BROMIDE
TABLET;ORAL
METHSCOPOLAMINE BROMIDE
PVT FORM 2.5MG A080970 001
METHYCLOTHIAZIDE
TABLET;ORAL
AQUATENSEN
MEDPOINTE PHARM HLC 5MG N017364 001
ENDURON
ABBVIE 2.5MG **Federal Register determination N012524 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
5MG N012524 004
METHYCLOTHIAZIDE
IVAX PHARMS 2.5MG A087913 001 Jun 03, 1982
5MG A087786 001 May 18, 1982
MYLAN 2.5MG A087671 001 Aug 17, 1982
PAR PHARM 2.5MG A089135 001 Feb 12, 1986
5MG A089136 001 Feb 12, 1986
SANDOZ 2.5MG A089835 001 Aug 18, 1988
5MG A089837 001 Aug 18, 1988
USL PHARMA 5MG A088745 001 Mar 21, 1985
WATSON LABS 2.5MG A085487 001 Mar 11, 1982
2.5MG A088750 001 Sep 06, 1984
5MG A085476 001 Mar 11, 1982
5MG A088724 001 Sep 06, 1984
METHYCLOTHIAZIDE; PARGYLINE HYDROCHLORIDE
TABLET;ORAL
EUTRON
ABBOTT 5MG;25MG N016047 001
METHYCLOTHIAZIDE; RESERPINE
TABLET;ORAL
DIUTENSEN-R
MEDPOINTE PHARM HLC 2.5MG;0.1MG N012708 005
METHYL AMINOLEVULINATE HYDROCHLORIDE
CREAM;TOPICAL
METVIXIA
GALDERMA LABS LP EQ 16.8% BASE N021415 001 Jul 27, 2004
METHYLDOPA
SUSPENSION;ORAL
ALDOMET
MERCK 250MG/5ML N018389 001
TABLET;ORAL
ALDOMET
MERCK 125MG N013400 003
250MG N013400 001
500MG N013400 002
METHYLDOPA
ACCORD HLTHCARE 125MG A070070 003 Oct 15, 1985
DURAMED PHARMS BARR 250MG A071006 001 Dec 16, 1986
500MG A071009 001 Dec 16, 1986
HALSEY 125MG A071751 001 Mar 28, 1988
250MG A071752 001 Mar 28, 1988
500MG A071753 001 Mar 28, 1988
MUTUAL PHARM 125MG A070073 001 Oct 09, 1986
250MG A070060 001 Oct 09, 1986
500MG A070074 001 Oct 09, 1986
PAR PHARM 125MG A070535 001 Jan 02, 1987
250MG A070536 001 Jan 02, 1987
500MG A070537 001 Jan 02, 1987
PARKE DAVIS 125MG A070331 001 Apr 15, 1986
250MG A070332 001 Apr 15, 1986
500MG A070333 001 Apr 15, 1986
PLIVA 125MG A072126 001 Jul 07, 1988
250MG A072127 001 Jul 07, 1988
500MG A072128 001 Jul 07, 1988
PUREPAC PHARM 125MG A070749 001 Feb 07, 1986
250MG A070750 001 Feb 07, 1986
500MG A070452 001 Feb 07, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-212( of 322)
METHYLDOPA
TABLET;ORAL
METHYLDOPA
ROXANE 125MG A070192 001 Apr 25, 1986
250MG A070193 001 Apr 25, 1986
500MG A070194 001 Apr 25, 1986
SANDOZ 125MG A071700 001 Mar 02, 1988
250MG N018934 001 Jun 29, 1984
500MG N018934 002 Jun 29, 1984
SUPERPHARM 250MG A070669 001 Jun 23, 1989
500MG A070670 001 Jun 23, 1989
TEVA 125MG A071105 001 Dec 05, 1986
250MG A071106 001 Dec 05, 1986
500MG A071067 001 Dec 05, 1986
WATSON LABS 125MG A070245 001 Feb 25, 1986
125MG A070260 001 Jun 24, 1985
250MG A070246 001 Feb 25, 1986
250MG A070261 001 Jun 24, 1985
250MG A070703 001 Jun 06, 1986
500MG A070247 001 Feb 25, 1986
500MG A070262 001 Jun 24, 1985
METHYLDOPATE HYDROCHLORIDE
INJECTABLE;INJECTION
ALDOMET
MERCK 50MG/ML N013401 001
METHYLDOPATE HYDROCHLORIDE
ABRAXIS PHARM 50MG/ML A070652 001 Jun 03, 1986
BAXTER HLTHCARE 50MG/ML A070291 001 Jul 01, 1986
HOSPIRA 50MG/ML A070691 001 Jun 19, 1987
50MG/ML A070698 001 Jun 15, 1987
50MG/ML A070699 001 Jun 15, 1987
50MG/ML A070849 001 Jun 19, 1987
MARSAM PHARMS LLC 50MG/ML A071812 001 Dec 22, 1987
SMITH AND NEPHEW 50MG/ML A070841 001 Jan 02, 1987
TEVA PARENTERAL 50MG/ML A072974 001 Nov 22, 1991
METHYLPHENIDATE HYDROCHLORIDE
TABLET;ORAL
METHYLPHENIDATE HYDROCHLORIDE
ABLE 5MG A040404 001 Mar 29, 2001
10MG A040404 002 Mar 29, 2001
20MG A040404 003 Mar 29, 2001
ACTAVIS ELIZABETH 5MG A040321 001 Feb 05, 2002
10MG A040321 002 Feb 05, 2002
20MG A040321 003 Feb 05, 2002
TABLET, EXTENDED RELEASE;ORAL
METADATE ER
UCB INC 10MG **Federal Register determination A040306 001 Oct 20, 1999
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
METHYLPHENIDATE HYDROCHLORIDE
ABLE 20MG A076032 001 May 09, 2001
ACTAVIS ELIZABETH 20MG A075450 001 Dec 21, 2001
METHYLPREDNISOLONE
TABLET;ORAL
MEDROL
PHARMACIA AND UPJOHN 24MG N011153 005
METHYLPREDNISOLONE
HEATHER 4MG A085650 001
PAR PHARM 16MG A089207 001 Apr 25, 1988
24MG A089208 001 Apr 25, 1988
32MG A089209 001 Apr 25, 1988
SANDOZ 4MG A087341 001
WATSON LABS 4MG A086161 001 Feb 09, 1982
16MG A086159 001 Feb 09, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-213( of 322)
METHYLPREDNISOLONE ACETATE
ENEMA;RECTAL
MEDROL
PHARMACIA AND UPJOHN 40MG/BOT N018102 001
INJECTABLE;INJECTION
M-PREDROL
BEL MAR 40MG/ML A086666 001
80MG/ML A087135 001
METHYLPREDNISOLONE ACETATE
AKORN 40MG/ML A086903 001 Oct 20, 1982
80MG/ML A086903 002 Oct 20, 1982
WATSON LABS 20MG/ML A085597 001
20MG/ML A087248 001
40MG/ML A085374 001
40MG/ML A085600 001
80MG/ML A085595 001
80MG/ML A086507 001
OINTMENT;TOPICAL
MEDROL ACETATE
PHARMACIA AND UPJOHN 0.25% N012421 001
1% N012421 002
METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE
CREAM;TOPICAL
NEO-MEDROL ACETATE
PHARMACIA AND UPJOHN 0.25%;EQ 3.5MG BASE/GM A060611 002
1%;EQ 3.5MG BASE/GM A060611 001
METHYLPREDNISOLONE SODIUM SUCCINATE
INJECTABLE;INJECTION
A-METHAPRED
ABBOTT EQ 1GM BASE/VIAL A089576 001 Feb 22, 1991
EQ 40MG BASE/VIAL A089573 001 Feb 22, 1991
EQ 125MG BASE/VIAL A089574 001 Feb 22, 1991
EQ 500MG BASE/VIAL A089575 001 Feb 22, 1991
HOSPIRA EQ 1GM BASE/VIAL A085852 001
EQ 1GM BASE/VIAL A089174 001 Aug 18, 1987
EQ 40MG BASE/VIAL A085853 001
EQ 125MG BASE/VIAL A085855 001
EQ 500MG BASE/VIAL A085854 001
EQ 500MG BASE/VIAL A089173 001 Aug 18, 1987
METHYLPREDNISOLONE
ELKINS SINN EQ 1GM BASE/VIAL A086906 004
EQ 125MG BASE/VIAL A086906 002
EQ 500MG BASE/VIAL A086906 003
ORGANON USA INC EQ 1GM BASE/VIAL A087535 002 Jun 25, 1982
EQ 500MG BASE/VIAL A087535 001 Jun 25, 1982
METHYLPREDNISOLONE SODIUM SUCCINATE
ABRAXIS PHARM EQ 1GM BASE/VIAL A088679 001 Jun 08, 1984
EQ 1GM BASE/VIAL A089188 001 Mar 28, 1986
EQ 1GM BASE/VIAL A089189 001 Mar 28, 1986
EQ 40MG BASE/VIAL A088676 001 Jun 08, 1984
EQ 40MG BASE/VIAL A089143 001 Mar 28, 1986
EQ 125MG BASE/VIAL A088677 001 Jun 08, 1984
EQ 125MG BASE/VIAL A089144 001 Mar 28, 1986
EQ 500MG BASE/VIAL A088678 001 Jun 08, 1984
EQ 500MG BASE/VIAL A089186 001 Mar 28, 1986
EQ 500MG BASE/VIAL A089187 001 Mar 28, 1986
BEDFORD LABS EQ 1GM BASE/VIAL A040641 004 Feb 21, 2007
EQ 1GM BASE/VIAL A040709 002 Feb 21, 2007
EQ 40MG BASE/VIAL A040662 001 Feb 21, 2007
EQ 125MG BASE/VIAL A040641 002 Feb 21, 2007
EQ 500MG BASE/VIAL A040641 003 Feb 21, 2007
EQ 500MG BASE/VIAL A040709 001 Feb 21, 2007
ELKINS SINN EQ 40MG BASE/VIAL A086906 001
INTL MEDICATION EQ 1GM BASE/VIAL A087852 001 Feb 09, 1983
EQ 40MG BASE/VIAL A087812 001 Feb 09, 1983
EQ 125MG BASE/VIAL A087813 001 Feb 09, 1983
EQ 500MG BASE/VIAL A087851 001 Feb 09, 1983
TEVA PARENTERAL EQ 1GM BASE/VIAL A081268 001 Nov 30, 1992
EQ 125MG BASE/VIAL A081266 001 Nov 30, 1992
EQ 500MG BASE/VIAL A081267 001 Nov 30, 1992
WATSON LABS EQ 1GM BASE/VIAL A088524 001 Jul 24, 1984
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
METHYLPREDNISOLONE SODIUM SUCCINATE
INJECTABLE;INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATE
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
METHYLPREDNISOLONE; NEOMYCIN SULFATE
OINTMENT;OPHTHALMIC
NEO-MEDROL
PHARMACIA AND UPJOHN 0.1%;EQ 3.5MG BASE/GM
METHYLTESTOSTERONE
CAPSULE;ORAL
METHYLTESTOSTERONE
HEATHER 10MG
VIRILON
STAR PHARMS FL 10MG
TABLET;BUCCAL
ANDROID 5
VALEANT PHARM INTL 5MG
ORETON
SCHERING 10MG
TABLET;BUCCAL, SUBLINGUAL
METANDREN
NOVARTIS 5MG
10MG
10MG
25MG
METHYLTESTOSTERONE
IMPAX LABS 10MG
LILLY 10MG
25MG
PUREPAC PHARM 10MG
10MG
10MG
25MG
PVT FORM 5MG
TABLICAPS 10MG
USL PHARMA 10MG
TABLET;ORAL
METHYLTESTOSTERONE
INWOOD LABS 10MG
25MG
KV PHARM 10MG
LANNETT 10MG
25MG
PARKE DAVIS 10MG
25MG
PUREPAC PHARM 10MG
25MG
PVT FORM 5MG
10MG
25MG
TABLICAPS 10MG
25MG
WATSON LABS 10MG
25MG
WEST WARD 10MG
25MG
25MG
ORETON METHYL
SCHERING 10MG
25MG
METHYPRYLON
CAPSULE;ORAL
NOLUDAR
ROCHE 300MG
ELIXIR;ORAL
NOLUDAR
ROCHE 50MG/5ML
6-214( of 322)
A086953 001 Jul 22, 1982
A087030 001 Jul 22, 1982
A088523 001 Jul 24, 1984
A060645 001
A084967 001
A087750 001 Nov 24, 1982
A087222 001
A080281 001
N003240 004
N003240 001
N003240 005
N003240 003
A084287 001
A080256 001
A080256 002
A080308 001
A080475 001
A080475 002
A080475 003
A083836 001
A085125 001
A080271 001
A080839 001
A080973 001
A084312 001
A087092 001 Nov 05, 1982
A087111 001 Jan 27, 1983
A084244 001
A084241 001
A080309 001
A080310 001
A080214 001
A080214 002
A080214 003
A080313 001
A085270 001
A080933 001
A080931 001
A084331 001
A084331 002
A084642 001
N003158 001
N003158 002
N009660 008
N009660 007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-215( of 322)
METHYPRYLON
TABLET;ORAL
NOLUDAR
ROCHE 50MG N009660 002
200MG N009660 004
METHYSERGIDE MALEATE
TABLET;ORAL
SANSERT
NOVARTIS 2MG N012516 001
METOCLOPRAMIDE HYDROCHLORIDE
CONCENTRATE;ORAL
METOCLOPRAMIDE INTENSOL
ROXANE EQ 10MG BASE/ML A072995 001 Jan 30, 1992
INJECTABLE;INJECTION
METOCLOPRAMIDE HYDROCHLORIDE
BEDFORD
HOSPIRA
LYPHOMED
NORBROOK
SMITH AND NEPHEW
REGLAN
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 10MG BASE/2ML
EQ 10MG BASE/2ML
EQ 5MG BASE/ML
EQ 10MG BASE/2ML
A072155 001
A072244 001
A072247 001
A070505 001
A070506 001
A070847 001
A071291 001
A071990 001
A073117 001
A074147 001
A070293 001
A070892 001
A070623 001
A070622 001
Mar 30, 1992
Mar 30, 1992
May 18, 1992
Jun 23, 1989
Jun 22, 1989
Nov 07, 1988
Mar 03, 1989
Jan 18, 1989
Jan 17, 1991
Aug 02, 1996
Jan 24, 1986
Aug 26, 1988
Mar 02, 1987
Mar 02, 1987
BAXTER HLTHCARE CORP EQ 10MG BASE/ML
SOLUTION;ORAL
METOCLOPRAMIDE HYDROCHLORIDE
N017862 004 May 28, 1987
ACTAVIS MID ATLANTIC
MORTON GROVE
PACO
ROXANE
TEVA
REGLAN
EQ 5MG BASE/5ML
EQ 5MG BASE/5ML
EQ 5MG BASE/5ML
EQ 5MG BASE/5ML
EQ 5MG BASE/5ML
EQ 5MG BASE/5ML
A071340 001
A070949 001
A071665 001
A072038 001
A070819 001
A071315 001
Aug 18, 1988
Mar 06, 1987
Dec 05, 1988
Dec 05, 1988
Jul 10, 1987
Jun 30, 1993
ROBINS AH
TABLET;ORAL
CLOPRA
EQ 5MG BASE/5ML N018821 001 Mar 25, 1983
QUANTUM PHARMICS
CLOPRA-"YELLOW"
EQ 5MG BASE
EQ 10MG BASE
A072384 001
A070294 001
Jun 02, 1988
Jul 29, 1985
QUANTUM PHARMICS
MAXOLON
EQ 10MG BASE A070632 001 Oct 28, 1985
KING PHARMS EQ 10MG BASE
METOCLOPRAMIDE HYDROCHLORIDE
A070106 001 Mar 04, 1986
CLONMEL HLTHCARE EQ 10MG BASE
HALSEY EQ 10MG BASE
INTERPHARM EQ 10MG BASE
MUTUAL PHARM EQ 10MG BASE
EQ 10MG BASE
PAR PHARM EQ 10MG BASE
SANDOZ EQ 5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 10MG BASE
SCHERING EQ 10MG BASE
SUPERPHARM EQ 10MG BASE
USL PHARMA EQ 10MG BASE
WATSON LABS EQ 10MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 10MG BASE
TABLET, ORALLY DISINTEGRATING;ORAL
METOZOLV ODT
A072639 001
A070906 001
A071213 001
A070660 001
A071536 001
A070342 001
A072436 001
A074478 001
A070850 001
A072215 001
A074478 002
A070598 001
A070926 001
A070339 001
A070363 001
A070453 001
A070511 001
A070645 001
May 09, 1991
Oct 28, 1986
Sep 24, 1986
Feb 10, 1987
Apr 28, 1993
Mar 25, 1986
Jun 22, 1989
Oct 05, 1995
Feb 03, 1987
Jan 30, 1990
Oct 05, 1995
Feb 02, 1987
Jun 26, 1987
Jul 29, 1985
Mar 02, 1987
Jun 06, 1986
Jan 22, 1986
May 11, 1987
SALIX PHARMS EQ 10MG BASE N022246 002 Sep 04, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-216( of 322)
METOCLOPRAMIDE HYDROCHLORIDE
TABLET, ORALLY DISINTEGRATING;ORAL
REGLAN ODT
MEDA PHARMS EQ 5MG BASE
EQ 10MG BASE
N021793 001
N021793 002
Jun 10, 2005
Jun 10, 2005
METOCURINE IODIDE
INJECTABLE;INJECTION
METUBINE IODIDE
LILLY 2MG/ML N006632 003
METOLAZONE
TABLET;ORAL
DIULO
GD SEARLE LLC 2.5MG N018535 001
5MG N018535 002
10MG N018535 003
METOLAZONE
ROXANE
TEVA
WATSON LABS
MYKROX
10MG
2.5MG
5MG
10MG
10MG
A076482 002
A076600 001
A076833 001
A075543 003
A076891 001
Apr 29, 2004
Jan 06, 2004
Mar 01, 2004
Dec 24, 2003
Jul 21, 2004
UCB INC 0.5MG N019532 001 Oct 30, 1987
METOPROLOL FUMARATE
TABLET, EXTENDED RELEASE;ORAL
LOPRESSOR
NOVARTIS EQ 100MG TARTRATE
EQ 200MG TARTRATE
EQ 300MG TARTRATE
EQ 400MG TARTRATE
N019786 001
N019786 002
N019786 003
N019786 004
Dec 27, 1989
Dec 27, 1989
Dec 27, 1989
Dec 27, 1989
METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
METOPROLOL SUCCINATE
NESHER PHARMS
SANDOZ
EQ 25MG TARTRATE
EQ 50MG TARTRATE
EQ 100MG TARTRATE
EQ 200MG TARTRATE
EQ 25MG TARTRATE
EQ 50MG TARTRATE
EQ 100MG TARTRATE
EQ 200MG TARTRATE
A077779 001
A077176 001
A076640 002
A076640 001
A076969 001
A076969 002
A076969 003
A076969 004
Mar 20, 2008
May 14, 2008
May 18, 2007
May 18, 2007
Jul 31, 2006
May 18, 2007
Mar 20, 2008
Mar 20, 2008
METOPROLOL TARTRATE
INJECTABLE;INJECTION
METOPROLOL TARTRATE
WATSON LABS
TABLET;ORAL
METOPROLOL TARTRATE
1MG/ML A074032 001 Dec 21, 1993
APOTHECON
MYLAN
PRINSTON INC
PUREPAC PHARM
TEVA
TEVA PHARMS
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
A074258 001
A074258 002
A073666 001
A073666 002
A074453 001
A074453 002
A074380 001
A074380 002
A074143 001
A074143 002
A074333 001
A074333 002
Jan 27, 1994
Jan 27, 1994
Dec 21, 1993
Dec 21, 1993
Apr 27, 1995
Apr 27, 1995
Jul 29, 1994
Jul 29, 1994
Sep 30, 1994
Sep 30, 1994
Jan 27, 1994
Jan 27, 1994
METRIZAMIDE
INJECTABLE;INJECTION
AMIPAQUE
GE HEALTHCARE 2.5GM/VIAL
3.75GM/VIAL
6.75GM/VIAL
13.5GM/VIAL
N017982 003
N017982 001
N017982 002
N017982 004
Sep 12, 1983
Sep 12, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-217( of 322)
METRONIDAZOLE
CAPSULE;ORAL
METRONIDAZOLE
ABLE 375MG A076505 001 Nov 13, 2003
INJECTABLE;INJECTION
METRO I.V.
B BRAUN 500MG/100ML N018674 001 Aug 31, 1982
METRONIDAZOLE
ABBOTT 500MG/100ML N018889 001 Nov 18, 1983
ABRAXIS PHARM 500MG/100ML A070071 001 Dec 03, 1984
HIKMA MAPLE 500MG/100ML N018907 001 Mar 30, 1984
INTL MEDICATION 500MG/100ML A070004 001 May 08, 1985
WATSON LABS 500MG/100ML A070042 001 Dec 20, 1984
500MG/100ML A070170 001 Apr 01, 1986
TABLET;ORAL
METROMIDOL
LABS AF 250MG A074523 001 Oct 24, 1996
500MG A074523 002 Oct 24, 1996
METRONIDAZOLE
ABLE 250MG A076519 001 Jun 27, 2003
500MG A076519 002 Jun 27, 2003
HALSEY 250MG A070021 001 Apr 02, 1985
500MG A070593 001 Feb 27, 1986
IVAX SUB TEVA PHARMS 250MG N018517 001
500MG N018517 002 May 05, 1982
LNK 250MG N019029 001 Apr 10, 1984
MUTUAL PHARM 250MG N018818 001 Feb 16, 1983
500MG N018818 002 Feb 16, 1983
PAR PHARM 250MG N018845 001 Aug 18, 1983
500MG N018930 001 Aug 18, 1983
SANDOZ 250MG N018620 001 Mar 04, 1982
250MG N018740 001 Oct 22, 1982
500MG N018620 002 Jun 02, 1983
500MG N018740 002 Oct 22, 1982
SUPERPHARM 250MG A070008 001 Dec 11, 1984
500MG A070009 001 Dec 11, 1984
WATSON LABS 250MG N018599 001 Sep 17, 1982
500MG N018599 002 Feb 13, 1984
WORLD GEN 250MG A070040 001 Jan 29, 1985
500MG A070039 001 Jan 29, 1985
PROTOSTAT
ORTHO MCNEIL PHARM 250MG N018871 001 Mar 02, 1983
500MG N018871 002 Mar 02, 1983
SATRIC
SAVAGE LABS 250MG A070029 001 Mar 19, 1985
500MG A070731 001 Jun 08, 1987
TABLET, EXTENDED RELEASE;ORAL
METRONIDAZOLE
ABLE 750MG A076462 001 Jun 25, 2003
METRONIDAZOLE HYDROCHLORIDE
INJECTABLE;INJECTION
FLAGYL I.V.
PFIZER EQ 500MG BASE/VIAL N018353 001
METRONIDAZOLE HYDROCHLORIDE
ABRAXIS PHARM EQ 500MG BASE/VIAL A070295 001 Oct 15, 1985
METYRAPONE
TABLET;ORAL
METOPIRONE
HRA PHARMA 250MG N012911 001
MEXILETINE HYDROCHLORIDE
CAPSULE;ORAL
MEXILETINE HYDROCHLORIDE
SANDOZ 150MG A074450 001 May 16, 1996
200MG A074450 002 May 16, 1996
250MG A074450 003 May 16, 1996
WATSON LABS 150MG A074711 001 Feb 26, 1997
150MG A074865 001 Apr 13, 1998
200MG A074711 002 Feb 26, 1997
200MG A074865 002 Apr 13, 1998
250MG A074711 003 Feb 26, 1997
250MG A074865 003 Apr 13, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-218( of 322)
MEXILETINE HYDROCHLORIDE
CAPSULE;ORAL
MEXITIL
BOEHRINGER INGELHEIM 150MG N018873 002 Dec 30, 1985
200MG N018873 003 Dec 30, 1985
250MG N018873 004 Dec 30, 1985
MEZLOCILLIN SODIUM MONOHYDRATE
INJECTABLE;INJECTION
MEZLIN
BAYER PHARMS EQ 1GM BASE/VIAL A062333 001
EQ 1GM BASE/VIAL A062372 005 Jan 13, 1983
EQ 1GM BASE/VIAL N050549 001
EQ 2GM BASE/VIAL A062333 002
EQ 2GM BASE/VIAL A062372 001 May 13, 1982
EQ 2GM BASE/VIAL N050549 002
EQ 3GM BASE/VIAL A062333 003
EQ 3GM BASE/VIAL A062372 002 May 13, 1982
EQ 3GM BASE/VIAL A062697 001 Jan 22, 1987
EQ 3GM BASE/VIAL N050549 003
EQ 4GM BASE/VIAL A062333 004
EQ 4GM BASE/VIAL A062372 003 May 13, 1982
EQ 4GM BASE/VIAL A062697 002 Jan 22, 1987
EQ 4GM BASE/VIAL N050549 004
EQ 20GM BASE/VIAL A062372 004 Mar 02, 1988
EQ 20GM BASE/VIAL N050549 005 Mar 02, 1988
MICONAZOLE
INJECTABLE;INJECTION
MONISTAT
JANSSEN PHARMA 10MG/ML N018040 001
MICONAZOLE NITRATE
CREAM;TOPICAL
MONISTAT-DERM
INSIGHT PHARMS 2% N017494 001
CREAM;VAGINAL
MICONAZOLE NITRATE
TEVA 2% A074136 001 Jan 04, 1995
TEVA PHARMS 2% A074030 001 Oct 30, 1992
CREAM, SUPPOSITORY;TOPICAL, VAGINAL
M-ZOLE 7 DUAL PACK
ACTAVIS MID ATLANTIC 2%,100MG A074586 001 Jul 17, 1997
LOTION;TOPICAL
MONISTAT-DERM
INSIGHT PHARMS 2% N017739 001
TAMPON;VAGINAL
MONISTAT 5
PERSONAL PRODS 100MG N018592 001 Oct 27, 1989
MIDAZOLAM HYDROCHLORIDE
INJECTABLE;INJECTION
MIDAZOLAM HYDROCHLORIDE
APOTEX INC EQ 1MG BASE/ML A075637 001 Oct 31, 2000
EQ 5MG BASE/ML A075637 002 Oct 31, 2000
APOTHECON EQ 1MG BASE/ML A075620 001 Nov 01, 2000
EQ 5MG BASE/ML A075620 002 Nov 01, 2000
EQ 5MG BASE/ML A075641 001 Oct 19, 2000
ASTRAZENECA EQ 5MG BASE/ML A075263 001 Jun 26, 2000
BEDFORD EQ 5MG BASE/ML A075249 001 Jun 23, 2000
BEN VENUE EQ 5MG BASE/ML A075455 001 Jun 20, 2000
HOSPIRA EQ 1MG BASE/ML A075396 001 Jun 20, 2000
EQ 5MG BASE/ML A075396 002 Jun 20, 2000
EQ 5MG BASE/ML A075484 001 Jun 20, 2000
HOSPIRA INC EQ 1MG BASE/ML A075409 002 Jun 20, 2000
EQ 5MG BASE/ML A075409 001 Jun 20, 2000
INTL MEDICATED EQ 1MG BASE/ML A076144 001 Jan 26, 2005
EQ 5MG BASE/ML A076144 002 Jan 26, 2005
INTL MEDICATION EQ 1MG BASE/ML A076020 001 Jul 16, 2004
EQ 5MG BASE/ML A076020 002 Jul 16, 2004
VERSED
HLR EQ 1MG BASE/ML N018654 002 May 26, 1987
EQ 5MG BASE/ML N018654 001 Dec 20, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-219( of 322)
MIDAZOLAM HYDROCHLORIDE
SYRUP;ORAL
MIDAZOLAM HYDROCHLORIDE
APOTEX INC EQ 2MG BASE/ML A077115 001 Sep 09, 2005
VERSED
ROCHE EQ 2MG BASE/ML N020942 001 Oct 15, 1998
MIDODRINE HYDROCHLORIDE
TABLET;ORAL
PROAMATINE
SHIRE LLC 2.5MG N019815 001 Sep 06, 1996
5MG N019815 002 Sep 06, 1996
10MG N019815 003 Mar 20, 2002
MILRINONE LACTATE
INJECTABLE;INJECTION
MILRINONE LACTATE
APOTEX INC EQ 1MG BASE/ML A076427 001 Sep 21, 2004
HIKMA MAPLE EQ 1MG BASE/ML A075852 001 May 28, 2002
HOSPIRA EQ 1MG BASE/ML A075830 001 May 28, 2002
EQ 1MG BASE/ML A075884 001 May 28, 2002
MYLAN INSTITUTIONAL EQ 1MG BASE/ML A076428 001 Jun 16, 2003
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
APOTEX INC EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A077151 001 Jul 20, 2005
BAXTER HLTHCARE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A076259 001 Aug 08, 2002
HIKMA MAPLE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075510 001 May 28, 2002
PRIMACOR
SANOFI AVENTIS US EQ 1MG BASE/ML N019436 001 Dec 31, 1987
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
SANOFI AVENTIS US EQ 10MG BASE/100ML N020343 001 Aug 09, 1994
EQ 15MG BASE/100ML N020343 002 Aug 09, 1994
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) N020343 003 Aug 09, 1994
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) N020343 004 Aug 09, 1994
MINOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL
DYNACIN
MEDICIS EQ 50MG BASE A063066 001 Aug 14, 1990
MINOCIN
PRECISION DERMAT EQ 75MG BASE N050649 003 Feb 12, 2001
TRIAX PHARMS EQ 50MG BASE N050315 002
EQ 100MG BASE N050315 001
CAPSULE, EXTENDED RELEASE;ORAL
XIMINO
RANBAXY LABS LTD EQ 45MG BASE N201922 001 Jul 11, 2012
EQ 67.5MG BASE N201922 002 Jul 11, 2012
EQ 90MG BASE N201922 003 Jul 11, 2012
EQ 112.5MG BASE N201922 004 Jul 11, 2012
EQ 135MG BASE N201922 005 Jul 11, 2012
INJECTABLE;INJECTION
MINOCIN
LEDERLE EQ 100MG BASE/VIAL A062139 001
SUSPENSION;ORAL
MINOCIN
PRECISION DERMAT EQ 50MG BASE/5ML N050445 001
TABLET;ORAL
MINOCYCLINE HYDROCHLORIDE
TRIAX PHARMS EQ 50MG BASE N050451 003 Aug 10, 1982
EQ 100MG BASE N050451 002 Aug 10, 1982
TABLET, EXTENDED RELEASE;ORAL
MINOCYCLINE HYDROCHLORIDE
LUPIN LTD EQ 55MG BASE A091424 002 Nov 30, 2011
SOLODYN
MEDICIS EQ 45MG BASE **Federal Register N050808 001 May 08, 2006
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 90MG BASE **Federal Register N050808 002 May 08, 2006
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 135MG BASE **Federal Register N050808 003 May 08, 2006
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-220( of 322)
MINOXIDIL
SOLUTION;TOPICAL
MINOXIDIL (FOR MEN)
APOTEX INC 2% A074924 001 Apr 29, 1998
BAUSCH AND LOMB 2% A074643 001 Apr 09, 1996
COPLEY PHARM 2% A074500 001 May 23, 1996
SIGHT PHARMS 2% A074743 002 Oct 18, 1996
TEVA 2% A074589 001 Apr 05, 1996
MINOXIDIL (FOR WOMEN)
APOTEX INC 2% A074924 002 Apr 29, 1998
SIGHT PHARMS 2% A074743 001 Oct 18, 1996
MINOXIDIL EXTRA STRENGTH (FOR MEN)
APOTEX INC 5% A075839 001 Oct 01, 2001
TABLET;ORAL
LONITEN
PHARMACIA AND UPJOHN 2.5MG N018154 001
10MG N018154 003
MINODYL
QUANTUM PHARMICS 2.5MG A072153 001 Jul 13, 1988
10MG A071534 001 Mar 19, 1987
MINOXIDIL
ROYCE LABS 2.5MG A071799 001 Nov 10, 1987
10MG A071796 001 Nov 10, 1987
USL PHARMA 2.5MG A071537 001 Dec 16, 1988
MIRTAZAPINE
TABLET;ORAL
MIRTAZAPINE
ACTAVIS ELIZABETH 15MG A076308 001 Jun 20, 2003
30MG A076308 002 Jun 20, 2003
45MG A076308 003 Jun 20, 2003
ACTAVIS TOTOWA 15MG A076241 001 Jun 25, 2003
30MG A076241 002 Jun 25, 2003
45MG A076241 003 Jun 25, 2003
IVAX SUB TEVA PHARMS 15MG A076244 001 Dec 22, 2003
30MG A076244 002 Dec 22, 2003
45MG A076244 003 Dec 22, 2003
ROXANE 15MG A076270 001 Jun 19, 2003
30MG A076270 002 Jun 19, 2003
45MG A076270 003 Jun 19, 2003
SANDOZ 15MG A076189 001 Jun 19, 2003
30MG A076189 002 Jun 19, 2003
45MG A076189 003 Jun 19, 2003
TABLET, ORALLY DISINTEGRATING;ORAL
MIRTAZAPINE
ACTAVIS ELIZABETH 15MG A077959 001 Feb 14, 2011
30MG A077959 002 Feb 14, 2011
45MG A077959 003 Feb 14, 2011
ACTAVIS TOTOWA 15MG A076689 001 Aug 31, 2005
30MG A076689 002 Aug 31, 2005
45MG A076689 003 Aug 31, 2005
MITOMYCIN
INJECTABLE;INJECTION
MITOMYCIN
HOSPIRA 20MG/VIAL A064106 001 Nov 29, 1995
MITOZYTREX
SUPERGEN 5MG/VIAL **Federal Register N050763 001 Nov 14, 2002
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
MUTAMYCIN
BRISTOL 5MG/VIAL N050450 001
20MG/VIAL N050450 002
BRISTOL MYERS 5MG/VIAL A062336 001
20MG/VIAL A062336 002
40MG/VIAL A062336 003 Mar 10, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
MITOXANTRONE HYDROCHLORIDE
INJECTABLE;INJECTION
MITOXANTRONE HYDROCHLORIDE
FRESENIUS KABI ONCOL
NOVANTRONE
EMD SERONO
MIVACURIUM CHLORIDE
INJECTABLE;INJECTION
MIVACRON
ABBVIE
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBVIE
MIVACURIUM CHLORIDE
STRIDES ARCOLAB LTD
MOLINDONE HYDROCHLORIDE
CAPSULE;ORAL
MOBAN
ENDO PHARMS
CONCENTRATE;ORAL
MOBAN
ENDO PHARMS
TABLET;ORAL
MOBAN
ENDO PHARMS
MOMETASONE FUROATE
OINTMENT;TOPICAL
MOMETASONE FUROATE
TARO
MONOBENZONE
CREAM;TOPICAL
BENOQUIN
VALEANT PHARM INTL
MONOCTANOIN
LIQUID;PERFUSION, BILIARY
MOCTANIN
ETHITEK
MORICIZINE HYDROCHLORIDE
TABLET;ORAL
ETHMOZINE
SHIRE
MORPHINE SULFATE
INJECTABLE;INJECTION
MORPHINE SULFATE
HOSPIRA
MALLINCKRODT
INJECTABLE, LIPOSOMAL;EPIDURAL
EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
EQ 30MG BASE/15ML (EQ 2MG BASE/ML)
EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
EQ 30MG BASE/15ML (EQ 2MG BASE/ML)
EQ 2MG BASE/ML
EQ 0.5MG BASE/ML
EQ 50MG BASE/100ML
EQ 2MG BASE/ML
5MG
10MG
25MG
20MG/ML
5MG
10MG
25MG
50MG
100MG
0.1%
20%
100%
200MG
250MG
300MG
0.5MG/ML
1MG/ML
2MG/ML
6-221( of 322)
A078606 001 May 14, 2008
A078606 002 May 14, 2008
A078606 003 May 14, 2008
N019297 001 Dec 23, 1987
N019297 002 Dec 23, 1987
N019297 003 Dec 23, 1987
N020098 001 Jan 22, 1992
N020098 002 Jan 22, 1992
N020098 003 Jan 22, 1992
A078562 001 Apr 30, 2009
N017111 001
N017111 002
N017111 003
N017938 001
N017111 004
N017111 005
N017111 006
N017111 007
N017111 008
A076624 001 Dec 03, 2004
N008173 003
N019368 001 Oct 29, 1985
N019753 001 Jun 19, 1990
N019753 002 Jun 19, 1990
N019753 003 Jun 19, 1990
N019917 001 Oct 30, 1992
N020631 001 Jul 03, 1996
N020631 002 Jul 03, 1996
DEPODUR
PACIRA PHARMS INC 10MG/ML (10MG/ML)
15MG/1.5ML (10MG/ML)
20MG/2ML (10MG/ML)
TABLET, EXTENDED RELEASE;ORAL
MORPHINE SULFATE
N021671 001
N021671 002
N021671 003
May 18, 2004
May 18, 2004
May 18, 2004
WATSON LABS 100MG A075656 001 Jan 30, 2001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-222( of 322)
MORPHINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
ORAMORPH SR
XANODYNE PHARMS INC 15MG N019977 004 Nov 23, 1994
30MG N019977 001 Aug 15, 1991
60MG N019977 002 Aug 15, 1991
100MG N019977 003 Aug 15, 1991
MOXALACTAM DISODIUM
INJECTABLE;INJECTION
MOXAM
LILLY EQ 1GM BASE/VIAL N050550 003
EQ 2GM BASE/VIAL N050550 004
EQ 10GM BASE/VIAL N050550 008
EQ 250MG BASE/VIAL N050550 001
EQ 500MG BASE/VIAL N050550 002
MYCOPHENOLATE MOFETIL
CAPSULE;ORAL
MYCOPHENOLATE MOFETIL
ZYDUS PHARMS USA INC 250MG A065433 001 May 04, 2009
TABLET;ORAL
MYCOPHENOLATE MOFETIL
DR REDDYS LABS LTD 500MG A090464 001 Sep 13, 2010
ZYDUS PHARMS USA INC 500MG A065477 001 May 04, 2009
NABUMETONE
TABLET;ORAL
NABUMETONE
COPLEY PHARM 750MG A075179 001 Jun 06, 2000
DR REDDYS LABS LTD 500MG A078420 001 Sep 24, 2008
750MG A078420 002 Sep 24, 2008
PROSAM LABS 500MG A079093 001 Feb 27, 2009
750MG A079093 002 Feb 27, 2009
SANDOZ 500MG A075590 001 Feb 25, 2002
750MG A075590 002 Feb 25, 2002
RELAFEN
SMITHKLINE BEECHAM 500MG
750MG
N019583 001
N019583 002
Dec 24, 1991
Dec 24, 1991
NADOLOL
TABLET;ORAL
CORGARD
KING PHARMS 120MG N018063 003
160MG N018063 004
NADOLOL
IVAX SUB TEVA PHARMS
TEVA PHARMS
120MG
160MG
80MG
120MG
160MG
A074255 002
A074255 003
A074368 001
A074368 002
A074368 003
Jan 24, 1996
Jan 24, 1996
Aug 31, 1994
Aug 31, 1994
Aug 31, 1994
NAFCILLIN SODIUM
CAPSULE;ORAL
UNIPEN
WYETH AYERST
FOR SOLUTION;ORAL
UNIPEN
EQ 250MG BASE N050111 001
WYETH AYERST
INJECTABLE;INJECTION
NAFCILLIN SODIUM
EQ 250MG BASE/5ML N050199 001
APOTHECON
MARSAM PHARMS LLC
SANDOZ
NALLPEN
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1.5GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
A061984 002
A061984 003
A061984 005
A061984 001
A062844 002
A062844 003
A062844 004
A062844 005
A063008 001
A062844 001
A062527 001
Oct 26, 1988
Oct 26, 1988
Oct 26, 1988
Oct 26, 1988
Sep 29, 1988
Oct 26, 1988
Aug 02, 1984
GLAXOSMITHKLINE EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
A061999 002
A062755 001 Dec 19, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-223( of 322)
NAFCILLIN SODIUM
INJECTABLE;INJECTION
NALLPEN
EQ 2GM BASE/VIAL A061999 003
EQ 2GM BASE/VIAL A062755 002 Dec 19, 1986
EQ 10GM BASE/VIAL A061999 004
EQ 500MG BASE/VIAL A061999 001
UNIPEN
WYETH AYERST EQ 1GM BASE/VIAL A062717 002 Dec 16, 1986
EQ 2GM BASE/VIAL A062717 004 Dec 16, 1986
EQ 2GM BASE/VIAL N050320 003
EQ 4GM BASE/VIAL N050320 004
EQ 10GM BASE/VIAL N050320 005
EQ 20GM BASE/VIAL N050320 006
EQ 500MG BASE/VIAL A062717 001 Dec 16, 1986
EQ 500MG BASE/VIAL N050320 001
UNIPEN IN PLASTIC CONTAINER
WYETH AYERST EQ 1GM BASE/VIAL N050320 002
TABLET;ORAL
UNIPEN
WYETH AYERST EQ 500MG BASE N050462 001
NALBUPHINE HYDROCHLORIDE
INJECTABLE;INJECTION
NALBUPHINE
ABRAXIS PHARM 10MG/ML A070751 001 Jul 02, 1986
20MG/ML A070752 001 Sep 24, 1986
NALBUPHINE HYDROCHLORIDE
ABBOTT 20MG/ML A070917 001 Feb 03, 1989
ABBVIE 1.5MG/ML N020200 001 Mar 12, 1993
ASTRAZENECA 10MG/ML A072070 001 Apr 10, 1989
10MG/ML A072071 001 Apr 10, 1989
10MG/ML A072072 001 Apr 10, 1989
20MG/ML A072073 001 Apr 10, 1989
20MG/ML A072074 001 Apr 10, 1989
20MG/ML A072075 001 Apr 10, 1989
BARR 10MG/ML A074471 001 Mar 19, 1998
20MG/ML A074471 002 Mar 19, 1998
NUBAIN
ENDO PHARMS 10MG/ML N018024 001
20MG/ML N018024 002 May 27, 1982
NALIDIXIC ACID
SUSPENSION;ORAL
NEGGRAM
SANOFI AVENTIS US 250MG/5ML N017430 001
TABLET;ORAL
NALIDIXIC ACID
MUTUAL PHARM 1GM A070272 001 Jun 29, 1988
250MG A070270 001 Jun 29, 1988
500MG A070271 001 Jun 29, 1988
WATSON LABS 1GM A071919 001 Jun 29, 1988
250MG A071936 001 Jun 29, 1988
500MG A072061 001 Jun 29, 1988
NEGGRAM
SANOFI AVENTIS US 1GM N014214 005
250MG N014214 002
500MG N014214 004
NALMEFENE HYDROCHLORIDE
INJECTABLE;INJECTION
REVEX
BAXTER HLTHCARE CORP EQ 0.1MG BASE/ML N020459 001 Apr 17, 1995
EQ 1MG BASE/ML N020459 002 Apr 17, 1995
NALOXONE HYDROCHLORIDE
INJECTABLE;INJECTION
NALOXONE
HIKMA MAPLE 0.4MG/ML A070298 001 Sep 24, 1986
0.4MG/ML A070299 001 Sep 24, 1986
0.4MG/ML A070496 001 Sep 24, 1986
WYETH AYERST 0.02MG/ML A070188 001 Sep 24, 1986
0.02MG/ML A070189 001 Sep 24, 1986
0.4MG/ML A070190 001 Sep 24, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
NALOXONE HYDROCHLORIDE
INJECTABLE;INJECTION
NALOXONE
0.4MG/ML
NALOXONE HYDROCHLORIDE
ABRAXIS PHARM 0.02MG/ML
0.02MG/ML
0.4MG/ML
1MG/ML
ASTRAZENECA 0.02MG/ML
0.02MG/ML
0.02MG/ML
0.02MG/ML
0.02MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
1MG/ML
1MG/ML
1MG/ML
HIKMA MAPLE 0.02MG/ML
1MG/ML
1MG/ML
1MG/ML
HOSPIRA 0.02MG/ML
0.02MG/ML
0.02MG/ML
0.4MG/ML
INTL MEDICATION 0.4MG/ML
1MG/ML
MARSAM PHARMS LLC 0.4MG/ML
SMITH AND NEPHEW 0.02MG/ML
0.4MG/ML
0.4MG/ML
SOLOPAK 0.02MG/ML
0.4MG/ML
WATSON LABS 0.4MG/ML
NARCAN
BRISTOL MYERS SQUIBB 0.4MG/ML
1MG/ML
1MG/ML
ENDO PHARMS 0.02MG/ML
0.4MG/ML
1MG/ML
NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
TALWIN NX
SANOFI AVENTIS US EQ 0.5MG BASE;EQ 50MG BASE
NALTREXONE HYDROCHLORIDE
TABLET;ORAL
NALTREXONE HYDROCHLORIDE
SANDOZ 50MG
NANDROLONE DECANOATE
INJECTABLE;INJECTION
DECA-DURABOLIN
ORGANON USA INC 50MG/ML
100MG/ML
200MG/ML
NANDROLONE DECANOATE
ABRAXIS PHARM 100MG/ML
200MG/ML
AKORN 100MG/ML
WATSON LABS 50MG/ML
50MG/ML
50MG/ML
100MG/ML
100MG/ML
200MG/ML
6-224( of 322)
A070191 001 Sep 24, 1986
A070648 001 Nov 17, 1986
A070661 001 Nov 17, 1986
A070649 001 Nov 17, 1986
A071604 001 Dec 16, 1988
A072081 001 Apr 11, 1989
A072082 001 Apr 11, 1989
A072083 001 Apr 11, 1989
A072084 001 Apr 11, 1989
A072085 001 Apr 11, 1989
A072086 001 Apr 11, 1989
A072087 001 Apr 11, 1989
A072088 001 Apr 11, 1989
A072089 001 Apr 11, 1989
A072090 001 Apr 11, 1989
A072091 001 Apr 11, 1989
A072092 001 Apr 11, 1989
A072093 001 Apr 11, 1989
A071272 001 May 24, 1988
A071273 001 May 24, 1988
A071274 001 May 24, 1988
A071287 001 May 24, 1988
A070171 001 Sep 24, 1986
A070252 001 Jan 16, 1987
A070253 001 Jan 16, 1987
A070255 001 Jan 07, 1987
A070417 001 Sep 24, 1986
A072115 001 Apr 27, 1988
A071811 001 Jul 19, 1988
A071671 001 Nov 17, 1987
A071681 001 Nov 17, 1987
A071682 001 Nov 17, 1987
A071672 001 Nov 17, 1987
A071683 001 Nov 17, 1987
A071339 001 Nov 18, 1987
A071083 001 Jul 28, 1988
A071084 001 Jul 28, 1988
A071311 001 Jul 28, 1988
N016636 002
N016636 001
N016636 003 Jun 14, 1982
N018733 001 Dec 16, 1982
A075434 001 Mar 08, 2000
N013132 001 Jun 12, 1986
N013132 002 Jun 12, 1986
N013132 003 Jun 12, 1986
A088290 001 Oct 03, 1983
A088317 001 Oct 14, 1983
A087519 001 Sep 28, 1983
A086385 001 Jan 13, 1984
A087598 001 Oct 06, 1983
A088554 001 Feb 10, 1986
A086598 001 Jan 13, 1984
A087599 001 Oct 06, 1983
A088128 001 Dec 05, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-225( of 322)
NANDROLONE PHENPROPIONATE
INJECTABLE;INJECTION
DURABOLIN
ORGANON USA INC 25MG/ML N011891 001
50MG/ML N011891 002
NANDROLONE PHENPROPIONATE
WATSON LABS 25MG/ML A086386 001 Jun 17, 1983
50MG/ML A087488 001 Jun 17, 1983
NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
NAFAZAIR
BAUSCH AND LOMB 0.1% A040073 001 May 25, 1994
PHARMAFAIR 0.1% A088101 001 Apr 15, 1983
NAPHCON FORTE
ALCON 0.1% A080229 001
OPCON
BAUSCH AND LOMB 0.1% A087506 001
VASOCON
NOVARTIS 0.1% A080235 002 Mar 24, 1983
NAPROXEN
TABLET;ORAL
NAPROXEN
DAVA PHARMS INC 250MG A074105 001 Dec 21, 1993
375MG A074105 002 Dec 21, 1993
500MG A074105 003 Dec 21, 1993
HAMILTON PHARMS 250MG A074110 001 Oct 30, 1992
375MG A074110 002 Oct 30, 1992
500MG A074110 003 Oct 30, 1992
IVAX SUB TEVA PHARMS 250MG A074111 001 Feb 28, 1995
375MG A074111 002 Feb 28, 1995
500MG A074111 003 Feb 28, 1995
PLIVA 250MG A074182 001 Jun 27, 1996
375MG A074182 002 Jun 27, 1996
500MG A074182 003 Jun 27, 1996
PUREPAC PHARM 250MG A074263 001 Dec 21, 1993
375MG A074263 002 Dec 21, 1993
500MG A074263 003 Dec 21, 1993
ROXANE 250MG A074211 001 Feb 28, 1994
375MG A074211 002 Feb 28, 1994
500MG A074211 003 Feb 28, 1994
TEVA 250MG A074129 001 Dec 21, 1993
250MG A074216 001 Apr 11, 1996
375MG A074129 002 Dec 21, 1993
375MG A074216 002 Apr 11, 1996
500MG A074129 003 Dec 21, 1993
500MG A074216 003 Apr 11, 1996
TEVA PHARMS 250MG A074207 001 Dec 21, 1993
375MG A074207 002 Dec 21, 1993
500MG A074207 003 Dec 21, 1993
WATSON LABS 250MG A074163 001 Feb 10, 1995
375MG A074163 002 Feb 10, 1995
500MG A074163 003 Feb 10, 1995
TABLET, DELAYED RELEASE;ORAL
NAPROXEN
ACTAVIS ELIZABETH 375MG A074936 001 Feb 24, 1998
500MG A074936 002 Feb 24, 1998
NAPROXEN SODIUM
TABLET;ORAL
NAPROXEN SODIUM
ABLE EQ 250MG BASE A076544 001 Aug 22, 2003
EQ 500MG BASE A076544 002 Aug 22, 2003
HAMILTON PHARMS EQ 250MG BASE A074106 001 Aug 31, 1993
EQ 500MG BASE A074106 002 Aug 31, 1993
IVAX SUB TEVA PHARMS EQ 250MG BASE A074230 001 Mar 14, 1995
EQ 500MG BASE A074230 002 Mar 14, 1995
MYLAN EQ 250MG BASE A074367 001 Aug 31, 1994
EQ 500MG BASE A074367 002 Aug 31, 1994
PLIVA EQ 250MG BASE A074242 001 Jun 20, 1996
EQ 500MG BASE A074242 002 Jun 20, 1996
PUREPAC PHARM EQ 250MG BASE A074319 001 Mar 20, 1995
EQ 500MG BASE A074319 002 Mar 20, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-226( of 322)
NAPROXEN SODIUM
TABLET;ORAL
NAPROXEN SODIUM
ROXANE EQ 250MG BASE A074257 001 Dec 21, 1993
EQ 500MG BASE A074257 002 Dec 21, 1993
SANDOZ EQ 200MG BASE A074646 001 Jan 13, 1997
EQ 250MG BASE A074162 001 Dec 21, 1993
EQ 250MG BASE A074495 001 Dec 05, 1994
EQ 500MG BASE A074162 002 Dec 21, 1993
EQ 500MG BASE A074495 002 Dec 05, 1994
TEVA EQ 250MG BASE A074142 001 Dec 21, 1993
EQ 500MG BASE A074142 002 Dec 21, 1993
TEVA PHARMS EQ 250MG BASE A074289 001 Jan 27, 1994
EQ 500MG BASE A074289 002 Jan 27, 1994
WATSON LABS EQ 250MG BASE A074195 001 Dec 21, 1993
EQ 500MG BASE A074195 002 Dec 21, 1993
TABLET, EXTENDED RELEASE;ORAL
NAPROXEN SODIUM
WATSON LABS FLORIDA EQ 375MG BASE A075416 002 Apr 23, 2003
EQ 500MG BASE A075416 001 Aug 27, 2002
NATEGLINIDE
TABLET;ORAL
NATEGLINIDE
TEVA PHARMS 60MG A077467 001 Sep 09, 2009
120MG A077467 002 Sep 09, 2009
NEDOCROMIL SODIUM
AEROSOL, METERED;INHALATION
TILADE
KING PHARMS 1.75MG/INH N019660 001 Dec 30, 1992
SOLUTION;INHALATION
TILADE
SANOFI AVENTIS US 0.5% N020750 001 Oct 01, 1997
NEFAZODONE HYDROCHLORIDE
TABLET;ORAL
NEFAZODONE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 50MG A075763 001 Sep 16, 2003
100MG A075763 002 Sep 16, 2003
150MG A075763 003 Sep 16, 2003
200MG A075763 004 Sep 16, 2003
250MG A075763 005 Sep 16, 2003
MYLAN 100MG A076129 002 Sep 16, 2003
150MG A076129 003 Sep 16, 2003
200MG A076129 004 Sep 16, 2003
250MG A076129 005 Sep 16, 2003
ROXANE 50MG A076196 001 Sep 16, 2003
100MG A076196 002 Sep 16, 2003
150MG A076196 003 Sep 16, 2003
200MG A076196 004 Sep 16, 2003
250MG A076196 005 Sep 16, 2003
SANDOZ 50MG A076072 001 Sep 16, 2003
50MG A076302 001 Sep 16, 2003
100MG A076072 002 Sep 16, 2003
100MG A076302 002 Sep 16, 2003
150MG A076072 003 Sep 16, 2003
150MG A076302 003 Sep 16, 2003
200MG A076072 004 Sep 16, 2003
200MG A076302 004 Sep 16, 2003
250MG A076072 005 Sep 16, 2003
250MG A076302 005 Sep 16, 2003
WATSON LABS 100MG A076073 002 Sep 16, 2003
150MG A076073 003 Sep 16, 2003
200MG A076073 004 Sep 16, 2003
250MG A076073 005 Sep 16, 2003
SERZONE
BRISTOL MYERS SQUIBB 50MG N020152 001 Dec 22, 1994
100MG N020152 002 Dec 22, 1994
150MG N020152 003 Dec 22, 1994
200MG N020152 004 Dec 22, 1994
250MG N020152 005 Dec 22, 1994
300MG N020152 006 Dec 22, 1994
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
NELFINAVIR MESYLATE
POWDER;ORAL
VIRACEPT
AGOURON
NEOMYCIN SULFATE
POWDER;FOR RX COMPOUNDING
NEO-RX
X GEN PHARMS
SOLUTION;ORAL
MYCIFRADIN
PHARMACIA AND UPJOHN
TABLET;ORAL
MYCIFRADIN
PHARMACIA AND UPJOHN
NEOBIOTIC
PFIZER
NEOMYCIN SULFATE
BRISTOL MYERS SQUIBB
LANNETT
LILLY
ROXANE
SANDOZ
EQ 50MG BASE/SCOOPFUL
100%
EQ 87.5MG BASE/5ML
EQ 350MG BASE
EQ 350MG BASE
500MG
500MG
500MG
500MG
500MG
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
CREAM;TOPICAL
NEOSPORIN
GLAXOSMITHKLINE
OINTMENT;OPHTHALMIC
STATROL
ALCON
SOLUTION/DROPS;OPHTHALMIC
STATROL
ALCON
EQ 3.5MG BASE/GM;10,000 UNITS/GM
EQ 3.5MG BASE/GM;10,000 UNITS/GM
EQ 3.5MG BASE/ML;16,250 UNITS/ML
EQ 3.5MG BASE/ML;16,250 UNITS/ML
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE
SUSPENSION/DROPS;OPHTHALMIC
POLY-PRED
ALLERGAN EQ 0.35% BASE;10,000 UNITS/ML;0.5%
NEOMYCIN SULFATE; PREDNISOLONE ACETATE
OINTMENT;OPHTHALMIC
NEO-DELTA-CORTEF
PHARMACIA AND UPJOHN
SUSPENSION/DROPS;OPHTHALMIC
NEO-DELTA-CORTEF
EQ 3.5MG BASE/GM;0.25%
EQ 3.5MG BASE/GM;0.5%
PHARMACIA AND UPJOHN EQ 3.5MG BASE/ML;0.25%
NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE
OINTMENT;OPHTHALMIC
NEO-HYDELTRASOL
MERCK EQ 3.5MG BASE/GM;EQ 0.25% PHOSPHATE
NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
MYTREX A
SAVAGE LABS EQ 3.5MG BASE/GM;0.1%
NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE
FOUGERA EQ 3.5MG BASE/GM;0.1%
PHARMADERM EQ 3.5MG BASE/GM;0.1%
OINTMENT;TOPICAL
MYTREX A
SAVAGE LABS EQ 3.5MG BASE/GM;0.1%
NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE
FOUGERA EQ 3.5MG BASE/GM;0.1%
PHARMADERM EQ 3.5MG BASE/GM;0.1%
NETILMICIN SULFATE
INJECTABLE;INJECTION
NETROMYCIN
SCHERING EQ 10MG BASE/ML
EQ 25MG BASE/ML
EQ 100MG BASE/ML
6-227( of 322)
N020778 001 Mar 14, 1997
A061579 001
N050285 001
A060520 001
A060475 001
A060365 001
A060607 001
A060385 001
A062173 001
A061586 001
N050176 002 Jan 14, 1985
N050344 002
A062339 001 Nov 30, 1984
N050456 001
N050081 002
A061039 002
A061039 001
A061037 001
N050378 001
A062598 001 Jul 21, 1986
A062600 001 Jul 21, 1986
A062595 001 Jul 21, 1986
A062609 001 May 23, 1986
A062608 001 May 23, 1986
A062607 001 May 23, 1986
N050544 001 Feb 28, 1983
N050544 002 Feb 28, 1983
N050544 003 Feb 28, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
NIACIN
CAPSULE;ORAL
WAMPOCAP
MEDPOINTE PHARM HLC
TABLET;ORAL
NIACIN
EVERYLIFE
HALSEY
IMPAX LABS
IVAX SUB TEVA PHARMS
MK LABS
PUREPAC PHARM
SANDOZ
TABLICAPS
WATSON LABS
WEST WARD
NICOLAR
SANOFI AVENTIS US
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
TABLET, EXTENDED RELEASE;ORAL
NIASPAN
ABBVIE 375MG
NIASPAN TITRATION STARTER PACK
ABBVIE 375MG
NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; TYROSINE
SUSPENSION;ORAL
TPN
INTL MINERALS 15MG/5ML;3.75MG/5ML;600MG/5ML
NICARDIPINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
CARDENE SR
EKR THERAP 45MG
NICLOSAMIDE
TABLET, CHEWABLE;ORAL
NICLOCIDE
BAYER PHARMS 500MG
NICOTINE
FILM, EXTENDED RELEASE;TRANSDERMAL
NICOTROL
MCNEIL CONS
PROSTEP
AVEVA
NICOTINE POLACRILEX
GUM, CHEWING;BUCCAL
NICOTINE POLACRILEX
WATSON LABS
NIFEDIPINE
CAPSULE;ORAL
ADALAT
BAYER PHARMS
NIFEDIPINE
CATALENT
CHASE LABS NJ
TEVA
PROCARDIA
PFIZER
TABLET, EXTENDED RELEASE;ORAL
NIFEDIPINE
MARTEC USA LLC
MYLAN
15MG/16HR
11MG/24HR
22MG/24HR
EQ 2MG BASE
EQ 4MG BASE
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
90MG
30MG
6-228( of 322)
N011073 003
A083203 001
A083453 001
A083115 001
A083180 001
A083525 001
A083271 001
A083306 001
A084237 001
A083136 001
A083305 001
A085172 001
A083718 001
A083823 001
N020381 001 Jul 28, 1997
N020381 005 Jul 28, 1997
N008378 003
N020005 002 Feb 21, 1992
N018669 001 May 14, 1982
N020536 001 Jul 03, 1996
N019983 003 Dec 23, 1998
N019983 004 Dec 23, 1998
A076568 001 Jul 29, 2004
A076569 002 Jul 29, 2004
N019478 001 Nov 27, 1985
N019478 002 Sep 17, 1986
A073250 001 Oct 08, 1991
A074045 001 Apr 30, 1992
A072409 001 Jul 04, 1990
A073421 001 Jun 19, 1991
A072651 001 Feb 19, 1992
N018482 002 Jul 24, 1986
A075414 003 Mar 23, 2004
A075108 001 Dec 17, 1999
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
NILUTAMIDE
TABLET;ORAL
NILANDRON
COVIS PHARMA SARL
NIMODIPINE
CAPSULE;ORAL
NIMOTOP
BAYER PHARMS
NISOLDIPINE
TABLET, EXTENDED RELEASE;ORAL
SULAR
SHIONOGI INC
NITROFURANTOIN
CAPSULE;ORAL
NITROFURANTOIN
WATSON LABS
TABLET;ORAL
FURADANTIN
PROCTER AND GAMBLE
FURALAN
LANNETT
NITROFURANTOIN
ELKINS SINN
IVAX SUB TEVA PHARMS
SANDOZ
WATSON LABS
WHITEWORTH TOWN PLSN
NITROFURANTOIN SODIUM
INJECTABLE;INJECTION
IVADANTIN
PROCTER AND GAMBLE
50MG
30MG
10MG
20MG
25.5MG
30MG
40MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
50MG
100MG
100MG
100MG
EQ 180MG BASE/VIAL
NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE;ORAL
NITROFURANTOIN
MYLAN 100MG
SANDOZ 25MG
50MG
100MG
WATSON LABS 25MG
50MG
100MG
NITROFURANTOIN MACROCRYSTALLINE
WATSON LABS 50MG
100MG
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE;ORAL
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
RANBAXY LABS LTD
NITROFURAZONE
CREAM;TOPICAL
FURACIN
SHIRE
DRESSING;TOPICAL
ACTIN-N
SHERWOOD MEDCL
75MG;25MG
0.2%
0.2%
6-229( of 322)
N020169 001 Sep 19, 1996
N018869 001 Dec 28, 1988
N020356 001 Feb 02, 1995
N020356 002 Feb 02, 1995
N020356 006 Jan 02, 2008
N020356 003 Feb 02, 1995
N020356 004 Feb 02, 1995
A084326 001
A084326 002
N008693 001
N008693 002
A080017 001
A080017 002
A080003 001
A080003 002
A080078 002
A080078 001
A080043 001
A080043 002
A080447 001
A085797 001
A080447 002
A085796 001
A084085 002
N012402 001
A074967 002 Jul 09, 1997
A074336 001 Jan 25, 1995
A074336 002 Jan 25, 1995
A074336 003 Jan 25, 1995
A073696 001 Dec 31, 1992
A073696 002 Dec 31, 1992
A073696 003 Dec 31, 1992
A070248 001 Jun 24, 1988
A070249 001 Jun 24, 1988
A076951 001 Mar 30, 2005
A083789 001
N017343 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-230( of 322)
NITROFURAZONE
OINTMENT;TOPICAL
FURACIN
SHIRE 0.2% N005795 001
NITROFURAZONE
AMBIX 0.2% A086077 001
LANNETT 0.2% A084393 001
PERRIGO NEW YORK 0.2% A084968 001
TARO 0.2% A086156 001
WENDT 0.2% A086766 001
POWDER;TOPICAL
FURACIN
SHIRE 0.2% A083791 001
SOLUTION;TOPICAL
NITROFURAZONE
PERRIGO NEW YORK 0.2% A085130 001
WENDT 0.2% A087081 001
NITROGLYCERIN
AEROSOL;SUBLINGUAL
NITROLINGUAL
POHL BOSKAMP 0.4MG/SPRAY N018705 001 Oct 31, 1985
FILM, EXTENDED RELEASE;TRANSDERMAL
NITROGLYCERIN
MYLAN TECHNOLOGIES 0.1MG/HR A074992 004 Nov 12, 1999
0.2MG/HR A074992 003 Nov 12, 1999
0.4MG/HR A074992 002 Nov 12, 1999
0.6MG/HR A074992 001 Nov 12, 1999
TRANSDERM-NITRO
NOVARTIS 0.1MG/HR N020144 001 Feb 27, 1996
0.2MG/HR N020144 002 Feb 27, 1996
0.4MG/HR N020144 003 Feb 27, 1996
0.6MG/HR N020144 004 Feb 27, 1996
0.8MG/HR N020144 005 Feb 27, 1996
INJECTABLE;INJECTION
NITRO IV
POHL BOSKAMP 5MG/ML N018672 002 Aug 30, 1983
NITRO-BID
SANOFI AVENTIS US 5MG/ML N018621 001 Jan 05, 1982
10MG/ML A071159 001 Feb 28, 1990
NITROGLYCERIN
ABRAXIS PHARM 5MG/ML A070077 001 Dec 13, 1985
5MG/ML A071203 001 May 08, 1987
HOSPIRA 5MG/ML **Federal Register determination N018531 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
INTL MEDICATION 5MG/ML A070026 001 Sep 10, 1985
LUITPOLD 5MG/ML A071492 001 May 24, 1988
SMITH AND NEPHEW 5MG/ML A070633 001 Jun 19, 1986
5MG/ML A070634 001 Jun 19, 1986
NITROGLYCERIN IN DEXTROSE 5%
HOSPIRA 0.1MG/ML A074083 001 Oct 26, 1994
NITROL
RORER 0.8MG/ML N018774 001 Jan 19, 1983
NITRONAL
POHL BOSKAMP 1MG/ML N018672 001 Aug 30, 1983
NITROSTAT
PARKE DAVIS 0.8MG/ML N018588 001
5MG/ML A070863 001 Jan 08, 1987
5MG/ML N018588 002 Dec 23, 1983
10MG/ML A070871 001 Jan 08, 1987
10MG/ML A070872 001 Jan 08, 1987
TRIDIL
HOSPIRA 0.5MG/ML N018537 002 Jun 16, 1983
5MG/ML N018537 001
NIZATIDINE
CAPSULE;ORAL
AXID
SMITHKLINE BEECHAM 150MG N019508 001 Apr 12, 1988
300MG N019508 002 Apr 12, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-231( of 322)
NIZATIDINE
CAPSULE;ORAL
NIZATIDINE
APOTEX INC
IVAX SUB TEVA PHARMS
MYLAN PHARMS INC
NONOXYNOL-9
AEROSOL;VAGINAL
DELFEN
PERSONAL PRODS
NOREPINEPHRINE BITARTRATE
INJECTABLE;INJECTION
NOREPINEPHRINE BITARTRATE
METRICS PHARM
150MG
300MG
150MG
300MG
150MG
300MG
12.5%
EQ 1MG BASE/ML
A076383 001 Jan 23, 2003
A076383 002 Jan 23, 2003
A075461 001 Jul 08, 2002
A075461 002 Jul 08, 2002
A075934 001 Jul 09, 2002
A075934 002 Jul 09, 2002
N014349 002
A040522 001 Sep 30, 2004
NOREPINEPHRINE BITARTRATE; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
RAVOCAINE AND NOVOCAIN W/ LEVOPHED
EASTMAN KODAK
NORETHINDRONE
TABLET;ORAL
NORLUTIN
PARKE DAVIS
NORETHINDRONE ACETATE
TABLET;ORAL
NORLUTATE
PARKE DAVIS
NORFLOXACIN
SOLUTION/DROPS;OPHTHALMIC
CHIBROXIN
MERCK
NORGESTREL
TABLET;ORAL
OVRETTE
WYETH PHARMS
NORTRIPTYLINE HYDROCHLORIDE
CAPSULE;ORAL
AVENTYL HYDROCHLORIDE
LILLY
NORTRIPTYLINE HYDROCHLORIDE
SANDOZ
TEVA
SOLUTION;ORAL
PAMELOR
MALLINCKRODT INC
NYSTATIN
CREAM;TOPICAL
CANDEX
BAYER PHARMS
MYCOSTATIN
BRISTOL MYERS SQUIBB
MYKINAC
ALPHARMA US PHARMS
EQ 0.033MG BASE/ML;2%;0.4%
5MG
5MG
0.3%
0.075MG
EQ 10MG BASE
EQ 25MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 10MG BASE/5ML
100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/GM
N008592 003
N010895 002
N012184 002
N019757 001 Jun 17, 1991
N017031 001
N014684 001
N014684 002
A074054 001 Dec 31, 1992
A074835 001 Jun 30, 1997
A074054 002 Dec 31, 1992
A074835 002 Jun 30, 1997
A074054 003 Dec 31, 1992
A074835 003 Jun 30, 1997
A074054 004 Dec 31, 1992
A074835 004 Jun 30, 1997
A073667 001 Apr 11, 1996
A073667 002 Apr 11, 1996
A073667 003 Apr 11, 1996
A073667 004 Apr 11, 1996
N018012 001
A061810 001
A060575 001
A062387 001 Jul 29, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
NYSTATIN
CREAM;TOPICAL
NILSTAT
LEDERLE
NYSTATIN
TARO
TEVA
LOTION;TOPICAL
CANDEX
BAYER PHARMS
OINTMENT;TOPICAL
MYCOSTATIN
WESTWOOD SQUIBB
MYKINAC
ALPHARMA US PHARMS
NILSTAT
LEDERLE
PASTILLE;ORAL
MYCOSTATIN
BRISTOL MYERS SQUIBB
POWDER;ORAL
BARSTATIN 100
BARLAN
NILSTAT
DAVA PHARMS INC
NYSTATIN
PADDOCK LLC
POWDER;TOPICAL
MYCOSTATIN
BRISTOL MYERS SQUIBB
NYSTATIN
NESHER PHARMS
SUPPOSITORY;VAGINAL
NYSERT
WARNER CHILCOTT
SUSPENSION;ORAL
MYCOSTATIN
APOTHECON
NILSTAT
GLENMARK GENERICS
NYSTATIN
ALPHARMA US PHARMS
MORTON GROVE
PHARMADERM
PHARMAFAIR
ROXANE
TEVA
NYSTEX
SAVAGE LABS
TABLET;ORAL
MYCOSTATIN
BRISTOL MYERS SQUIBB
NILSTAT
LEDERLE
NYSTATIN
QUANTUM PHARMICS
SANDOZ
USL PHARMA
WATSON LABS
TABLET;VAGINAL
KOROSTATIN
HOLLAND RANTOS
MYCOSTATIN
BRISTOL MYERS SQUIBB
NILSTAT
LEDERLE
NYSTATIN
FOUGERA
PHARMADERM
QUANTUM PHARMICS
SANDOZ
100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/ML
100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/GM
200,000 UNITS
100%
100%
100%
100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS
100,000 UNITS/ML
100,000 UNITS/ML
100,000 UNITS/ML
100,000 UNITS/ML
100,000 UNITS/ML
100,000 UNITS/ML
100,000 UNITS/ML
100,000 UNITS/ML
100,000 UNITS/ML
100,000 UNITS/ML
500,000 UNITS
500,000 UNITS
500,000 UNITS
500,000 UNITS
500,000 UNITS
500,000 UNITS
100,000 UNITS
100,000 UNITS
100,000 UNITS
100,000 UNITS
100,000 UNITS
100,000 UNITS
100,000 UNITS
6-232( of 322)
A061445 001
A062457 001 Jul 28, 1983
A061966 001
N050233 001
A060571 001
A062731 001 Sep 22, 1986
A061444 001
N050619 001 Apr 09, 1987
A062489 001 Apr 27, 1988
N050576 001 Dec 22, 1983
A062613 001 Nov 26, 1985
A060578 001
A065321 001 Aug 18, 2006
N050478 001
A061533 001
N050299 001
A062571 001 Oct 29, 1985
A062835 001 Nov 19, 1987
A062518 001 Jul 06, 1984
A062541 001 Jan 16, 1985
A062832 001 Dec 27, 1991
A062670 001 Jun 18, 1987
A062776 001 Dec 17, 1987
A062519 001 Jul 06, 1984
A060574 001
A061151 001
A062525 001 Oct 29, 1984
A062065 001
A062524 001 Nov 26, 1985
A062402 001 Dec 16, 1982
A061718 001
A060577 001
A061325 001
A062459 001 Nov 09, 1983
A062460 001 Nov 09, 1983
A062509 001 Apr 03, 1984
A061965 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-233( of 322)
NYSTATIN
TABLET;VAGINAL
NYSTATIN
TEVA 100,000 UNITS A062502 001 Dec 23, 1983
WATSON LABS 100,000 UNITS A062176 001
NYSTATIN; TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
MYCO-TRIACET II
TEVA 100,000 UNITS/GM;0.1% A061954 002 Sep 20, 1985
MYCOLOG-II
APOTHECON 100,000 UNITS/GM;0.1% A060576 002 May 01, 1985
100,000 UNITS/GM;0.1% A062606 001 May 15, 1985
MYKACET
G AND W LABS INC 100,000 UNITS/GM;0.1% A062367 001 May 28, 1985
MYTREX F
SAVAGE LABS 100,000 UNITS/GM;0.1% A062597 001 Oct 08, 1985
NYSTATIN AND TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS 100,000 UNITS/GM;0.1% A063010 001 Dec 20, 1988
PERRIGO NEW YORK 100,000 UNITS/GM;0.1% A062186 002 Jun 06, 1985
PHARMAFAIR 100,000 UNITS/GM;0.1% A062657 001 Jul 30, 1986
TARO 100,000 UNITS/GM;0.1% A062347 001 Mar 30, 1987
NYSTATIN-TRIAMCINOLONE ACETONIDE
PHARMADERM 100,000 UNITS/GM;0.1% A062596 001 Oct 08, 1985
OINTMENT;TOPICAL
MYCO-TRIACET II
TEVA 100,000 UNITS/GM;0.1% A062045 002 Nov 26, 1985
MYCOLOG-II
APOTHECON 100,000 UNITS/GM;0.1% A060572 001 Jun 28, 1985
MYKACET
G AND W LABS INC 100,000 UNITS/GM;0.1% A062733 001 Mar 09, 1987
MYTREX F
SAVAGE LABS 100,000 UNITS/GM;0.1% A062601 001 Oct 09, 1985
NYSTATIN AND TRIAMCINOLONE ACETONIDE
PERRIGO NEW YORK 100,000 UNITS/GM;0.1% A062280 002 Oct 10, 1985
PHARMAFAIR 100,000 UNITS/GM;0.1% A062656 001 Jul 30, 1986
NYSTATIN-TRIAMCINOLONE ACETONIDE
PHARMADERM 100,000 UNITS/GM;0.1% A062603 001 Oct 09, 1985
OFLOXACIN
INJECTABLE;INJECTION
FLOXIN
ORTHO MCNEIL PHARM 20MG/ML N020087 002 Mar 31, 1992
40MG/ML N020087 003 Mar 31, 1992
FLOXIN IN DEXTROSE 5%
ORTHO MCNEIL PHARM 400MG/100ML N020087 001 Mar 31, 1992
FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ORTHO MCNEIL PHARM 4MG/ML N020087 004 Mar 31, 1992
400MG/100ML N020087 005 Mar 31, 1992
OFLOXACIN
BEDFORD 40MG/ML A075762 001 Jan 16, 2002
SOLUTION/DROPS;OPHTHALMIC
OFLOXACIN
APOTEX INC 0.3% A076513 001 May 14, 2004
SANDOZ 0.3% A076848 001 Nov 25, 2008
TABLET;ORAL
FLOXIN
JANSSEN PHARMS 200MG N019735 001 Dec 28, 1990
300MG N019735 002 Dec 28, 1990
400MG N019735 003 Dec 28, 1990
OFLOXACIN
LARKEN LABS 200MG A076093 001 Sep 02, 2003
300MG A076093 002 Sep 02, 2003
400MG A076093 003 Sep 02, 2003
RANBAXY LABS LTD 200MG A076220 001 Sep 02, 2003
300MG A076220 002 Sep 02, 2003
400MG A076220 003 Sep 02, 2003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-234( of 322)
ONDANSETRON
TABLET, ORALLY DISINTEGRATING;ORAL
ONDANSETRON
NESHER PHARMS
PAR PHARM
4MG
8MG
4MG
8MG
16MG
24MG
A077717 001
A077717 002
A076506 001
A076506 002
A077406 001
A077406 002
Jun 25, 2007
Jun 25, 2007
Dec 26, 2006
Dec 26, 2006
Dec 26, 2006
Dec 26, 2006
ONDANSETRON HYDROCHLORIDE
INJECTABLE;INJECTION
ONDANSETRON HYDROCHLORIDE
APOTEX INC EQ 2MG BASE/ML
HOSPIRA EQ 2MG BASE/ML
LUITPOLD EQ 2MG BASE/ML
PLIVA HRVATSKA DOO EQ 2MG BASE/ML
SAGENT PHARMS EQ 2MG BASE/ML
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
A077368 001
A076695 001
A077582 001
A077544 001
A078180 001
Dec 26, 2006
Dec 26, 2006
Dec 26, 2006
Dec 26, 2006
Mar 26, 2007
BEDFORD LABS EQ 0.64MG BASE/ML
CLARIS LIFESCIENCES EQ 0.64MG BASE/ML
HOSPIRA EQ 0.64MG BASE/ML
EQ 0.64MG BASE/ML
TEVA PHARMS EQ 0.64MG BASE/ML
ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER
A078291 001
A078308 001
A076978 001
A077348 001
A077480 001
Apr 13, 2009
Mar 17, 2008
Feb 26, 2007
Feb 01, 2007
Nov 22, 2006
BAXTER HLTHCARE EQ 0.64MG BASE/ML
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
N021915 002 Dec 27, 2006
APOTEX INC EQ 2MG BASE/ML
HOSPIRA EQ 2MG BASE/ML
LUITPOLD EQ 2MG BASE/ML
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
A077343 001
A076696 001
A077387 001
Dec 26, 2006
Dec 26, 2006
Dec 26, 2006
GLAXOSMITHKLINE
TABLET;ORAL
ONDANSETRON HYDROCHLORIDE
EQ 0.64MG BASE/ML N020403 001 Jan 31, 1995
PAR PHARM
TARO
WEST WARD PHARM CORP
EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE
EQ 4MG BASE
EQ 8MG BASE
EQ 24MG BASE
A077303 001
A077303 002
A077303 004
A077729 001
A077729 002
A077729 003
A077545 001
A077545 002
A077545 003
Jun 25, 2007
Jun 25, 2007
Jun 25, 2007
Mar 28, 2011
Mar 28, 2011
Mar 28, 2011
Sep 06, 2007
Sep 06, 2007
Sep 06, 2007
ORPHENADRINE CITRATE
TABLET, EXTENDED RELEASE;ORAL
NORFLEX
MEDICIS 100MG N012157 001
ORPHENADRINE CITRATE
ASCOT
SANDOZ
100MG
100MG
A088067 001
A085046 001
Apr 06, 1983
WATSON LABS 100MG A084303 001
ORPHENADRINE HYDROCHLORIDE
TABLET;ORAL
DISIPAL
3M 50MG N010653 001
OSELTAMIVIR PHOSPHATE
FOR SUSPENSION;ORAL
TAMIFLU
ROCHE EQ 12MG BASE/ML N021246 001 Dec 14, 2000
OXACILLIN SODIUM
CAPSULE;ORAL
BACTOCILL
GLAXOSMITHKLINE
OXACILLIN SODIUM
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
A061336 001
A062241 001
A061336 002
A062241 002
APOTHECON
TEVA
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
A061450 002
A061450 001
A062222 001
A062222 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
OXACILLIN SODIUM
CAPSULE;ORAL
PROSTAPHLIN
APOTHECON
FOR SOLUTION;ORAL
BACTOCILL
GLAXOSMITHKLINE
OXACILLIN SODIUM
APOTHECON
TEVA
PROSTAPHLIN
APOTHECON
INJECTABLE;INJECTION
BACTOCILL
GLAXOSMITHKLINE
OXACILLIN SODIUM
APOTHECON
ELKINS SINN
IBI
MARSAM PHARMS LLC
SANDOZ
WATSON LABS
OXALIPLATIN
INJECTABLE;IV (INFUSION)
ELOXATIN
SANOFI AVENTIS US
OXALIPLATIN
SANDOZ
OXAMNIQUINE
CAPSULE;ORAL
VANSIL
PFIZER
OXANDROLONE
TABLET;ORAL
OXANDROLONE
ROXANE
SANDOZ
DISCONTINUED DRUG PRODUCT LIST
EQ 500MG BASE
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 10GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
50MG/VIAL **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
100MG/VIAL
50MG/VIAL
100MG/VIAL
250MG
2.5MG
10MG
2.5MG
10MG
N050118 002
A062321 001
A061457 001
A062252 001
N050194 001
A061334 006
A062736 001
A061334 007
A062736 002
A061334 008
A061334 010
A061334 009
N050195 003
N050195 004
N050195 005
N050195 001
N050195 002
A062711 003
A062711 004
A062711 005
A062711 006
A062711 001
A062711 002
A062798 001
A062798 002
A062798 003
A062798 004
A062798 005
A062984 001
A061490 001
A061490 002
A062856 003
A062856 004
A062856 005
A062856 001
A062856 002
N021492 001
N021492 002
A090849 001
A090849 002
N018069 001
A077249 001
A077249 002
A076897 001
A076897 002
6-235( of 322)
Mar 26, 1982
Dec 19, 1986
Mar 26, 1982
Dec 19, 1986
Mar 26, 1982
Mar 26, 1982
Feb 03, 1989
Feb 03, 1989
Feb 03, 1989
Feb 03, 1989
Feb 03, 1989
Feb 03, 1989
Dec 11, 1995
Dec 11, 1995
Dec 11, 1995
Dec 11, 1995
Dec 11, 1995
Sep 29, 1988
Oct 26, 1988
Oct 26, 1988
Oct 26, 1988
Oct 26, 1988
Oct 26, 1988
Aug 09, 2002
Aug 09, 2002
Apr 28, 2011
Apr 28, 2011
Jul 10, 2007
Jul 10, 2007
Dec 01, 2006
Dec 01, 2006
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-236( of 322)
OXAPROZIN
TABLET;ORAL
OXAPROZIN
ACTAVIS ELIZABETH 600MG A075843 001 Oct 03, 2001
MYLAN 600MG A075851 001 Aug 17, 2001
MYLAN PHARMS INC 600MG A075847 001 Feb 28, 2001
SANDOZ 600MG A075842 001 Apr 12, 2001
600MG A075850 001 Apr 27, 2001
OXAPROZIN POTASSIUM
TABLET;ORAL
DAYPRO ALTA
GD SEARLE 600MG N020776 001 Oct 17, 2002
OXAZEPAM
CAPSULE;ORAL
OXAZEPAM
AM THERAP 10MG A071955 001 Mar 03, 1988
15MG A071956 001 Mar 03, 1988
30MG A071957 001 Mar 03, 1988
MUTUAL PHARM 10MG A071026 002 Aug 10, 1987
15MG A071026 003 Aug 10, 1987
30MG A071026 001 Aug 10, 1987
MYLAN 10MG A071713 001 Oct 20, 1987
15MG A071714 001 Oct 20, 1987
30MG A071715 001 Oct 20, 1987
SERAX
ALPHARMA US PHARMS 10MG N015539 002
15MG N015539 004
30MG N015539 006
ZAXOPAM
QUANTUM PHARMICS 10MG A070650 001 Mar 01, 1988
15MG A070640 001 Mar 01, 1988
30MG A070641 001 Mar 01, 1988
TABLET;ORAL
OXAZEPAM
MUTUAL PHARM 15MG A070683 001 Jan 16, 1987
PARKE DAVIS 15MG A071508 001 Feb 02, 1987
WATSON LABS 15MG A071494 001 Apr 21, 1987
SERAX
ALPHARMA US PHARMS 15MG N015539 008
OXCARBAZEPINE
TABLET;ORAL
OXCARBAZEPINE
TEVA PHARMS USA 150MG A078005 001 Dec 11, 2007
300MG A078005 002 Dec 11, 2007
600MG A078005 003 Dec 11, 2007
OXPRENOLOL HYDROCHLORIDE
CAPSULE;ORAL
TRASICOR
NOVARTIS 20MG N018166 001 Dec 28, 1983
40MG N018166 002 Dec 28, 1983
80MG N018166 003 Dec 28, 1983
160MG N018166 004 Dec 28, 1983
OXTRIPHYLLINE
SOLUTION;ORAL
CHOLEDYL
PARKE DAVIS 100MG/5ML N009268 012 Nov 27, 1984
OXTRIPHYLLINE
MORTON GROVE 100MG/5ML A088243 001 Dec 05, 1983
SYRUP;ORAL
CHOLEDYL
PARKE DAVIS 50MG/5ML N009268 011
OXTRIPHYLLINE PEDIATRIC
MORTON GROVE 50MG/5ML A088242 001 Dec 05, 1983
TABLET, DELAYED RELEASE;ORAL
CHOLEDYL
PARKE DAVIS 100MG N009268 003
200MG N009268 007
OXTRIPHYLLINE
WATSON LABS 100MG A087866 001 Aug 25, 1983
200MG A087835 001 Aug 25, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
OXYBUTYNIN CHLORIDE
SYRUP;ORAL
DITROPAN
ORTHO MCNEIL JANSSEN
OXYBUTYNIN CHLORIDE
APOTEX INC
MIKART
TABLET;ORAL
DITROPAN
JANSSEN PHARMS
OXYBUTYNIN CHLORIDE
QUANTUM PHARMICS
USL PHARMA
WATSON LABS
OXYCODONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ROXICODONE
ROXANE
OXYMORPHONE HYDROCHLORIDE
INJECTABLE;INJECTION
OPANA
ENDO PHARMS
SUPPOSITORY;RECTAL
NUMORPHAN
ENDO PHARMS
TABLET, EXTENDED RELEASE;ORAL
OPANA ER
ENDO PHARMS
OXYPHENBUTAZONE
TABLET;ORAL
OXYPHENBUTAZONE
WATSON LABS
TANDEARIL
NOVARTIS
OXYPHENCYCLIMINE HYDROCHLORIDE
TABLET;ORAL
DARICON
PFIZER
OXYPHENONIUM BROMIDE
TABLET;ORAL
ANTRENYL
NOVARTIS
OXYTETRACYCLINE
TABLET;ORAL
TERRAMYCIN
PFIZER
OXYTETRACYCLINE CALCIUM
SYRUP;ORAL
TERRAMYCIN
PFIZER
OXYTETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
OXY-KESSO-TETRA
FERRANTE
5MG/5ML
5MG/5ML
5MG/5ML
5MG
5MG
5MG
5MG
10MG
30MG
1.5MG/ML
5MG
5MG
7.5MG
10MG
15MG
20MG
30MG
40MG
100MG
100MG
10MG
5MG
250MG
EQ 125MG BASE/5ML
EQ 250MG BASE
OXYTETRACYCLINE HYDROCHLORIDE
IMPAX LABS
PROTER
PUREPAC PHARM
WEST WARD
TERRAMYCIN
PFIZER
EQ 250MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 125MG BASE
6-237( of 322)
N018211 001
A074997 001 Oct 15, 1997
A075039 001 Jan 29, 1999
N017577 001
A072296 001 Dec 08, 1988
A070746 001 Mar 10, 1988
A072485 001 Apr 19, 1989
N020932 001 Oct 26, 1998
N020932 002 Oct 26, 1998
N011707 001
N011738 004
N021610 001 Jun 22, 2006
N021610 005 Feb 29, 2008
N021610 002 Jun 22, 2006
N021610 006 Feb 29, 2008
N021610 003 Jun 22, 2006
N021610 007 Feb 29, 2008
N021610 004 Jun 22, 2006
A088399 001 Sep 17, 1984
N012542 004 Sep 03, 1982
N011612 001
N008492 002
N050287 001
A060595 001
A060179 001
A060760 001
A060869 001
A060634 001
A060770 001
N050286 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
OXYTETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
TERRAMYCIN
EQ 250MG BASE
INJECTABLE;INJECTION
TERRAMYCIN
PFIZER EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE
OINTMENT;OTIC
TERRAMYCIN W/ POLYMYXIN
PFIZER EQ 5MG BASE/GM;10,000 UNITS/GM
TABLET;VAGINAL
TERRAMYCIN-POLYMYXIN
PFIZER EQ 100MG BASE;100,000 UNITS
OXYTOCIN
INJECTABLE;INJECTION
OXYTOCIN
TEVA PHARMS USA 10USP UNITS/ML (10USP UNITS/ML)
100USP UNITS/10ML (10USP UNITS/ML)
OXYTOCIN 10 USP UNITS IN DEXTROSE 5%
ABBOTT 1USP UNITS/100ML
2USP UNITS/100ML
OXYTOCIN 20 USP UNITS IN DEXTROSE 5%
ABBOTT 2USP UNITS/100ML
OXYTOCIN 5 USP UNITS IN DEXTROSE 5%
ABBOTT
SYNTOCINON
NOVARTIS
SOLUTION;NASAL
SYNTOCINON
NOVARTIS
PACLITAXEL
INJECTABLE;INJECTION
PACLITAXEL
ACCORD HLTHCARE
HOSPIRA
PLIVA LACHEMA
TEVA PHARMS USA
PALIPERIDONE
TABLET, EXTENDED RELEASE;ORAL
INVEGA
JANSSEN PHARMS
PALONOSETRON HYDROCHLORIDE
CAPSULE;ORAL
ALOXI
HELSINN HLTHCARE
PAMIDRONATE DISODIUM
INJECTABLE;INJECTION
AREDIA
NOVARTIS
PAMIDRONATE DISODIUM
AESGEN
1USP UNITS/100ML
10USP UNITS/ML
40USP UNITS/ML
6MG/ML
6MG/ML
6MG/ML
6MG/ML
12MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
EQ 0.5MG BASE **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
30MG/VIAL
60MG/VIAL
90MG/VIAL
30MG/VIAL
90MG/VIAL
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE;ORAL
COTAZYM
ORGANON USA INC 30000USPU;30000USPU;8000USPU
N050286 002
A060586 001
A060586 002
A061841 001
A061009 001
A077453 001
A077453 002
N019185 004
N019185 003
N019185 002
N019185 001
N018245 001
N012285 001
A075436 001
A076233 001
A077413 001
A075297 001
N021999 004
N022233 001
N020036 001
N020036 003
N020036 004
A075594 001
A075594 002
N020580 001
6-238( of 322)
Jan 24, 2008
Jan 24, 2008
Mar 29, 1985
Mar 29, 1985
Mar 29, 1985
Mar 29, 1985
Nov 12, 2004
Aug 01, 2002
Mar 12, 2008
Jan 25, 2002
Dec 19, 2006
Aug 22, 2008
Oct 31, 1991
May 06, 1993
May 06, 1993
May 06, 2002
May 06, 2002
Dec 09, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-239( of 322)
PANCURONIUM BROMIDE
INJECTABLE;INJECTION
PANCURONIUM BROMIDE
ASTRAZENECA 1MG/ML A072210 001 Mar 31, 1988
2MG/ML A072211 001 Mar 31, 1988
2MG/ML A072212 001 Mar 31, 1988
2MG/ML A072213 001 Mar 31, 1988
ELKINS SINN 1MG/ML A072058 001 Mar 23, 1988
2MG/ML A072059 001 Mar 23, 1988
2MG/ML A072060 001 Mar 23, 1988
HOSPIRA 2MG/ML A072321 001 Jan 19, 1989
PAVULON
ORGANON USA INC 1MG/ML N017015 002
2MG/ML N017015 001
PARAMETHADIONE
CAPSULE;ORAL
PARADIONE
ABBVIE 150MG N006800 003
300MG N006800 001
SOLUTION;ORAL
PARADIONE
ABBVIE 300MG/ML N006800 002
PARAMETHASONE ACETATE
TABLET;ORAL
HALDRONE
LILLY 1MG N012772 005
2MG N012772 006
PARGYLINE HYDROCHLORIDE
TABLET;ORAL
EUTONYL
ABBOTT 10MG N013448 002
25MG N013448 003
50MG N013448 004
PAROMOMYCIN SULFATE
CAPSULE;ORAL
HUMATIN
KING PFIZER EQ 250MG BASE A062310 001
PARKEDALE EQ 250MG BASE A060521 001
SYRUP;ORAL
HUMATIN
PARKE DAVIS EQ 125MG BASE/5ML A060522 001
PAROXETINE HYDROCHLORIDE
CAPSULE;ORAL
PAXIL
GLAXOSMITHKLINE EQ 10MG BASE **Federal Register N020885 001 Oct 09, 1998
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 20MG BASE **Federal Register N020885 002 Oct 09, 1998
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 30MG BASE **Federal Register N020885 003 Oct 09, 1998
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 40MG BASE **Federal Register N020885 004 Oct 09, 1998
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
SUSPENSION;ORAL
PAROXETINE HYDROCHLORIDE
APOTEX INC EQ 10MG BASE/5ML A077395 001 Dec 05, 2006
TABLET;ORAL
PAROXETINE HYDROCHLORIDE
ROXANE EQ 10MG BASE A078026 001 Jun 29, 2007
EQ 20MG BASE A078026 002 Jun 29, 2007
EQ 30MG BASE A078026 003 Jun 29, 2007
EQ 40MG BASE A078026 004 Jun 29, 2007
SANDOZ EQ 10MG BASE A075566 001 Mar 08, 2004
EQ 20MG BASE A075566 002 Mar 08, 2004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PAROXETINE HYDROCHLORIDE
TABLET;ORAL
PAROXETINE HYDROCHLORIDE
EQ 30MG BASE
EQ 40MG BASE
TEVA PHARMS EQ 10MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 40MG BASE
PAXIL
GLAXOSMITHKLINE EQ 50MG BASE
PEGINESATIDE ACETATE
SOLUTION;INTRAVENOUS, SUBCUTANEOUS
OMONTYS
TAKEDA PHARMS USA EQ 10MG BASE/ML (EQ 10MG BASE/ML)
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
OMONTYS PRESERVATIVE FREE
TAKEDA PHARMS USA EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)
EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)
EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)
EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)
EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)
EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)
PEMOLINE
TABLET;ORAL
CYLERT
ABBOTT 18.75MG
37.5MG
75MG
PEMOLINE
ACTAVIS TOTOWA 18.75MG
37.5MG
75MG
MALLINCKRODT 18.75MG
37.5MG
75MG
SANDOZ 18.75MG
37.5MG
75MG
TEVA PHARMS 18.75MG
37.5MG
75MG
VINTAGE PHARMS 18.75MG
37.5MG
75MG
WATSON LABS 18.75MG
37.5MG
75MG
TABLET, CHEWABLE;ORAL
CYLERT
ABBOTT 37.5MG
PEMOLINE
ACTAVIS TOTOWA 37.5MG
TEVA PHARMS 37.5MG
PENBUTOLOL SULFATE
TABLET;ORAL
LEVATOL
ACTIENT PHARMS 10MG
PENICILLAMINE
CAPSULE;ORAL
CUPRIMINE
ATON 125MG
PENICILLIN G BENZATHINE
INJECTABLE;INJECTION
BICILLIN L-A
WYETH AYERST 300,000 UNITS/ML
SUSPENSION;ORAL
BICILLIN
WYETH AYERST 300,000 UNITS/5ML
6-240( of 322)
A075566 003 Mar 08, 2004
A075566 004 Mar 08, 2004
A077082 001 Jun 29, 2007
A077082 002 Jun 29, 2007
A077082 003 Jun 29, 2007
A077082 004 Jun 29, 2007
N020031 004 Dec 29, 1992
N202799 007 Mar 27, 2012
N202799 008 Mar 27, 2012
N202799 001 Mar 27, 2012
N202799 002 Mar 27, 2012
N202799 003 Mar 27, 2012
N202799 004 Mar 27, 2012
N202799 005 Mar 27, 2012
N202799 006 Mar 27, 2012
N016832 001
N016832 002
N016832 003
A075595 001 Feb 28, 2000
A075595 002 Feb 28, 2000
A075595 003 Feb 28, 2000
A075726 003 Mar 30, 2001
A075726 002 Mar 30, 2001
A075726 001 Mar 30, 2001
A075286 001 Dec 27, 1999
A075286 002 Jun 30, 1999
A075286 003 Jun 30, 1999
A075030 003 Feb 22, 2000
A075030 001 Jan 29, 1999
A075030 002 Jan 29, 1999
A075328 001 Apr 19, 2000
A075328 002 Apr 19, 2000
A075328 003 Apr 19, 2000
A075287 001 Jun 13, 2001
A075287 002 Sep 18, 2000
A075287 003 Sep 18, 2000
N017703 001
A075678 001 Jul 26, 2000
A075555 001 Feb 18, 2000
N018976 001 Dec 30, 1987
N019853 002
N050131 001
N050126 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PENICILLIN G BENZATHINE
TABLET;ORAL
BICILLIN
WYETH AYERST 200,000 UNITS
PENICILLIN G POTASSIUM
FOR SOLUTION;ORAL
PENICILLIN
TEVA 200,000 UNITS/5ML
400,000 UNITS/5ML
PENICILLIN G POTASSIUM
MYLAN 200,000 UNITS/5ML
250,000 UNITS/5ML
400,000 UNITS/5ML
PUREPAC PHARM 250,000 UNITS/5ML
400,000 UNITS/5ML
PENICILLIN-2
TEVA 250,000 UNITS/5ML
PENTIDS '200'
APOTHECON 200,000 UNITS/5ML
PENTIDS '400'
APOTHECON 400,000 UNITS/5ML
PFIZERPEN G
PFIZER 400,000 UNITS/5ML
INJECTABLE;INJECTION
PENICILLIN G POTASSIUM
APOTHECON 1,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
10,000,000 UNITS/VIAL
20,000,000 UNITS/VIAL
CONSOLIDATED PHARM 500,000 UNITS/VIAL
1,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
10,000,000 UNITS/VIAL
LILLY 200,000 UNITS/VIAL
500,000 UNITS/VIAL
1,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
20,000,000 UNITS/VIAL
20,000,000 UNITS/VIAL
MARSAM PHARMS LLC 1,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
10,000,000 UNITS/VIAL
20,000,000 UNITS/VIAL
PARKE DAVIS 1,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
PFIZER 20,000,000 UNITS/VIAL
SANDOZ 1,000,000 UNITS/VIAL
PFIZERPEN
PFIZER 1,000,000 UNITS/VIAL
TABLET;ORAL
PENICILLIN G POTASSIUM
APOTHECON 250,000 UNITS
IVAX SUB TEVA PHARMS 400,000 UNITS
LILLY 250,000 UNITS
MYLAN 200,000 UNITS
250,000 UNITS
400,000 UNITS
500,000 UNITS
800,000 UNITS
PUREPAC PHARM 200,000 UNITS
250,000 UNITS
400,000 UNITS
TEVA 200,000 UNITS
250,000 UNITS
400,000 UNITS
500,000 UNITS
WYETH AYERST 200,000 UNITS
250,000 UNITS
400,000 UNITS
PENTIDS '200'
APOTHECON 200,000 UNITS
6-241( of 322)
N050128 001
A060307 002
A060307 004
A060752 003
A060752 002
A060752 001
A061740 001
A061740 002
A060307 003
A062149 001
A062149 002
A060587 001
A060362 001
A060362 003
A060362 004
A060362 002
A060806 001
A060806 002
A060806 003
A060806 004
A060384 004
A060384 003
A060384 002
A060384 001
A060384 005
A060601 001
A062991 001 Sep 13, 1988
A062991 002 Sep 13, 1988
A062991 003 Sep 13, 1988
A062991 004 Sep 13, 1988
A062003 001
A062003 002
A060074 003
A065079 001 Aug 30, 2002
A060657 001
A060392 003
A060073 004
A060403 001
A060781 001
A060781 002
A060781 003
A060781 005
A060781 004
A061588 001
A061588 002
A061588 003
A060306 001
A060306 002
A060306 003
A060306 004
A060413 001
A060413 002
A060413 003
A062155 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PENICILLIN G POTASSIUM
TABLET;ORAL
PENTIDS '250'
APOTHECON
PENTIDS '400'
APOTHECON
PENTIDS '800'
APOTHECON
PFIZERPEN G
PFIZER
PENICILLIN G PROCAINE
INJECTABLE;INJECTION
DURACILLIN A.S.
LILLY
PENICILLIN G PROCAINE
CONSOLIDATED PHARM
PARKE DAVIS
PFIZER
PFIZERPEN-AS
PFIZER
PENICILLIN G SODIUM
INJECTABLE;IM-IV
PENICILLIN G SODIUM
MARSAM PHARMS LLC
INJECTABLE;INJECTION
PENICILLIN G SODIUM
BRISTOL MYERS SQUIBB
COPANOS
PHARMACIA AND UPJOHN
PENICILLIN V
FOR SUSPENSION;ORAL
V-CILLIN
LILLY
PENICILLIN V POTASSIUM
FOR SOLUTION;ORAL
BEEPEN-VK
GLAXOSMITHKLINE
BETAPEN-VK
APOTHECON
LEDERCILLIN VK
LEDERLE
PEN-VEE K
WYETH AYERST
PENAPAR-VK
PARKE DAVIS
PENICILLIN V POTASSIUM
AM ANTIBIOTICS
MYLAN
PUREPAC PHARM
PFIZERPEN VK
PFIZER
250,000 UNITS
400,000 UNITS
400,000 UNITS
800,000 UNITS
800,000 UNITS
50,000 UNITS
100,000 UNITS
200,000 UNITS
250,000 UNITS
400,000 UNITS
800,000 UNITS
300,000 UNITS/ML
300,000 UNITS/ML
600,000 UNITS/1.2ML
300,000 UNITS/ML
300,000 UNITS/VIAL
1,500,000 UNITS/VIAL
300,000 UNITS/ML
600,000 UNITS/ML
5,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
1,000,000 UNITS/VIAL
125MG/0.6ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
6-242( of 322)
A062155 002
A060392 004
A062155 003
A060392 005
A062155 004
A060075 001
A060075 002
A060075 003
A060075 004
A060075 005
A060075 006
A060093 001
A060800 001
A060800 002
A062029 001
A060099 001
A060099 002
A060286 001
A060286 002
A063014 001 Sep 13, 1988
A061935 001
A061051 001
A061046 001
A060002 001
A062270 001
A062270 002
A061149 001
A061149 002
A060136 001
A060136 002
A060007 001
A060007 002
A062002 001
A062002 002
A061529 001
A061529 002
A061624 002
A061624 001
A061758 001
A061758 002
A061815 001
A061815 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PENICILLIN V POTASSIUM
FOR SOLUTION;ORAL
V-CILLIN K
LILLY EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
VEETIDS
APOTHECON EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
VEETIDS '125'
APOTHECON EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
VEETIDS '250'
APOTHECON EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
TABLET;ORAL
BEEPEN-VK
GLAXOSMITHKLINE EQ 250MG BASE
EQ 500MG BASE
BETAPEN-VK
BRISTOL EQ 250MG BASE
EQ 500MG BASE
LEDERCILLIN VK
LEDERLE EQ 250MG BASE
EQ 500MG BASE
PEN-VEE K
WYETH AYERST EQ 125MG BASE
EQ 250MG BASE
EQ 500MG BASE
PENAPAR-VK
PARKE DAVIS EQ 250MG BASE
EQ 500MG BASE
PENICILLIN V POTASSIUM
AM ANTIBIOTICS EQ 250MG BASE
EQ 500MG BASE
IVAX SUB TEVA PHARMS EQ 125MG BASE
EQ 250MG BASE
EQ 500MG BASE
MYLAN EQ 250MG BASE
EQ 500MG BASE
PUREPAC PHARM EQ 125MG BASE
EQ 250MG BASE
EQ 500MG BASE
PFIZERPEN VK
PFIZER EQ 250MG BASE
EQ 500MG BASE
UTICILLIN VK
PHARMACIA AND UPJOHN EQ 250MG BASE
EQ 500MG BASE
V-CILLIN K
LILLY EQ 125MG BASE
EQ 250MG BASE
EQ 500MG BASE
VEETIDS
APOTHECON EQ 250MG BASE
EQ 500MG BASE
VEETIDS '250'
APOTHECON EQ 250MG BASE
EQ 250MG BASE
VEETIDS '500'
APOTHECON EQ 500MG BASE
EQ 500MG BASE
PENTAGASTRIN
INJECTABLE;INJECTION
PEPTAVLON
WYETH AYERST 0.25MG/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
6-243( of 322)
A060004 001
A060004 002
A061410 001
A061410 002
A061206 001
A062153 001
A061206 002
A062153 002
A062273 001
A062273 002
A061150 001
A061150 002
A060134 001
A060134 002
A060006 001
A060006 002
A060006 003
A062001 001
A062001 002
A061528 001
A061528 002
A060518 001
A060518 002
A060518 003
A061530 001
A061530 002
A061571 001
A061571 002
A061571 003
A061836 001
A061836 002
A061651 001
A061651 002
A060003 001
A060003 002
A060003 003
A061411 001
A061411 002
A061164 001
A062156 002
A061164 002
A062156 001
N017048 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-244( of 322)
N019887 002 Mar 22, 1996
A073447 001 Apr 28, 1994
A073617 001 Dec 18, 1995
A073479 001 Jun 30, 1992
N016732 001
N021749 001 Aug 11, 2004
N017518 001
N021751 001 Aug 11, 2004
A083244 001
A084095 001
A084093 001
A083245 001
A085937 001
A085915 001
A083284 001
A083338 001
A084590 001
A083368 001
A083259 001
A084677 001
A083461 001
A083461 002
A084156 001
A084560 001
A083301 001
A083264 001
A085791 001
A083239 001
A083270 001
A083261 001
A083247 001 Jan 25, 1982
PENTAMIDINE ISETHIONATE
FOR SOLUTION;INHALATION
NEBUPENT
FRESENIUS KABI USA
INJECTABLE;INJECTION
PENTACARINAT
ARMOUR PHARM
PENTAMIDINE ISETHIONATE
BAXTER HLTHCARE
HOSPIRA
PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
TALWIN 50
SANOFI AVENTIS US
PENTETATE CALCIUM TRISODIUM
600MG/VIAL
300MG/VIAL
300MG/VIAL
300MG/VIAL
EQ 50MG BASE
PENTETATE ZINC TRISODIUM
HAMELN PHARMS
PENTOBARBITAL
ELIXIR;ORAL
NEMBUTAL
OAK PHARMS
PENTOBARBITAL SODIUM
CAPSULE;ORAL
NEMBUTAL SODIUM
OAK PHARMS
PENTOBARBITAL SODIUM
LANNETT
VITARINE
WHITEWORTH TOWN PLSN
SODIUM PENTOBARBITAL
ANABOLIC
ELKINS SINN
EVERYLIFE
HALSEY
IVAX SUB TEVA PHARMS
PARKE DAVIS
PERRIGO
PUREPAC PHARM
VALEANT PHARM INTL
WATSON LABS
WYETH AYERST
INJECTABLE;INJECTION
PENTOBARBITAL SODIUM
ELKINS SINN
SODIUM PENTOBARBITAL
WYETH AYERST
SUPPOSITORY;RECTAL
NEMBUTAL
OAK PHARMS
SOLUTION;INHALATION, INTRAVENOUS
PENTETATE CALCIUM TRISODIUM
HAMELN PHARMS EQ 1GM BASE/5ML (EQ 200MG BASE/ML)
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
PENTETATE CALCIUM TRISODIUM YB-169
INJECTABLE;INJECTION
YTTERBIUM YB 169 DTPA
3M 2mCi/ML
PENTETATE ZINC TRISODIUM
SOLUTION;INHALATION, INTRAVENOUS
EQ 1GM BASE/5ML (EQ 200MG BASE/ML)
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
18.2MG/5ML
30MG
50MG
100MG
50MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
50MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
50MG/ML
50MG/ML
30MG
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PENTOBARBITAL SODIUM
SUPPOSITORY;RECTAL
NEMBUTAL
TABLET;ORAL
PENTOBARBITAL SODIUM
VITARINE
SODIUM PENTOBARBITAL
NEXGEN PHARMA INC
PENTOLINIUM TARTRATE
INJECTABLE;INJECTION
ANSOLYSEN
WYETH AYERST
PENTOXIFYLLINE
TABLET, EXTENDED RELEASE;ORAL
PENTOXIFYLLINE
ACTAVIS ELIZABETH
HERITAGE PHARMS INC
TEVA
PERFLUBRON
LIQUID;ORAL
IMAGENT
ALLIANCE PHARM
60MG
120MG
200MG
100MG
100MG
10MG/ML
400MG
400MG
400MG
100%
PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE
PASTE;TOPICAL
SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS
US ARMY
PERGOLIDE MESYLATE
TABLET;ORAL
PERGOLIDE MESYLATE
IVAX SUB TEVA PHARMS
PAR PHARM
PERMAX
VALEANT PHARM INTL
PERMETHRIN
LOTION;TOPICAL
NIX
GLAXOSMITHKLINE
PERPHENAZINE
CONCENTRATE;ORAL
PERPHENAZINE
PHARM ASSOC
TRILAFON
SCHERING
INJECTABLE;INJECTION
TRILAFON
SCHERING
SYRUP;ORAL
TRILAFON
SCHERING
TABLET;ORAL
PERPHENAZINE
IVAX PHARMS
TRILAFON
SCHERING
50%;50%
EQ 0.05MG BASE
EQ 0.25MG BASE
EQ 1MG BASE
EQ 0.05MG BASE
EQ 0.25MG BASE
EQ 1MG BASE
EQ 0.05MG BASE
EQ 0.25MG BASE
EQ 1MG BASE
1%
16MG/5ML
16MG/5ML
5MG/ML
2MG/5ML
2MG
4MG
8MG
16MG
2MG
4MG
8MG
16MG
6-245( of 322)
A083247 002 Jan 25, 1982
A083247 003 Jan 25, 1982
A083247 004 Jan 25, 1982
A083285 001
A084238 001
N009372 001
A074878 001 Jul 09, 1997
A074877 001 Jul 08, 1997
A075199 001 Sep 03, 1999
N020091 001 Aug 13, 1993
N021084 001 Feb 17, 2000
A076094 001 Sep 04, 2003
A076094 002 Sep 04, 2003
A076094 003 Sep 04, 2003
A076061 001 Nov 27, 2002
A076061 002 Nov 27, 2002
A076061 003 Nov 27, 2002
N019385 001 Dec 30, 1988
N019385 002 Dec 30, 1988
N019385 003 Dec 30, 1988
N019435 001 Mar 31, 1986
A040360 001 May 25, 2001
N011557 001
N011213 002
N011294 002
A089707 001 Sep 10, 1987
A089708 001 Sep 10, 1987
A089456 001 Sep 10, 1987
A089457 001 Sep 10, 1987
N010775 001
N010775 002
N010775 003
N010775 004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-246( of 322)
PERPHENAZINE
TABLET, EXTENDED RELEASE;ORAL
TRILAFON
SCHERING 8MG N011361 002
PHENACEMIDE
TABLET;ORAL
PHENURONE
ABBVIE 500MG **Federal Register determination N007707 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE
TABLET;ORAL
AZO GANTANOL
ROCHE 100MG;500MG N013294 001 Sep 10, 1987
PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE; TRIMETHOPRIM
TABLET;ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PENAZOPYRIDINE HYDROCHLORIDE
ABLE 200MG;800MG;160MG N021105 001 Jun 26, 2001
PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE
TABLET;ORAL
AZO GANTRISIN
ROCHE 50MG;500MG N019358 001 Aug 31, 1990
PHENDIMETRAZINE TARTRATE
CAPSULE;ORAL
PHENAZINE
MAST MM 35MG A086523 001
35MG A086524 001
35MG A086525 001
PHENDIMETRAZINE TARTRATE
SANDOZ 35MG A085633 001
35MG A085694 001
35MG A085695 001
35MG A085702 001
VITARINE 35MG A085634 001
35MG A085645 001
35MG A085670 001
35MG A086403 001
35MG A086408 001
35MG A086410 001
35MG A087424 001
SPRX-3
SOLVAY 35MG A085897 001
STATOBEX
TEVA 35MG A085507 001
X-TROZINE
SHIRE RICHWOOD 35MG
CAPSULE, EXTENDED RELEASE;ORAL
MELFIAT-105
A087394 001 Sep 22, 1982
NUMARK
PHENDIMETRAZINE TARTRATE
105MG A087487 001 Oct 13, 1982
GRAHAM DM
SANDOZ
105MG
105MG
105MG
105MG
105MG
105MG
105MG
A087214 001
A088020 001
A088028 001
A088062 001
A088063 001
A088111 001
A087378 001
May 26, 1982
Aug 16, 1982
Aug 16, 1982
Sep 13, 1982
Sep 10, 1982
Oct 18, 1982
SPRX-105
NUMARK
X-TROZINE L.A.
105MG A088024 001 Dec 22, 1982
SHIRE RICHWOOD
TABLET;ORAL
ADPHEN
105MG A087371 001 Aug 24, 1982
FERNDALE LABS 35MG A083655 001
ALPHAZINE
SANDOZ 35MG A085034 001
CAM-METRAZINE
ABC HOLDING 35MG A085511 001
CAMALL 35MG A085756 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PHENDIMETRAZINE TARTRATE
TABLET;ORAL
CAM-METRAZINE
TG UNITED LABS 35MG
35MG
35MG
35MG
DI-METREX
PVT FORM 35MG
MELFIAT
NUMARK 35MG
METRA
FOREST PHARMS 35MG
PHENAZINE
MAST MM 35MG
PHENAZINE-35
ABC HOLDING 35MG
PHENDIMETRAZINE TARTRATE
BARR 35MG
35MG
35MG
35MG
35MG
35MG
35MG
FERNDALE LABS 35MG
INWOOD LABS 35MG
35MG
35MG
35MG
IVAX PHARMS 35MG
35MG
IVAX SUB TEVA PHARMS 35MG
KV PHARM 35MG
35MG
35MG
MFG CHEMISTS 35MG
NEXGEN PHARMA INC 35MG
NUMARK 35MG
PVT FORM 35MG
35MG
SANDOZ 35MG
35MG
35MG
35MG
35MG
SOLVAY 35MG
TG UNITED LABS 35MG
35MG
USL PHARMA 35MG
35MG
35MG
VITARINE 35MG
35MG
35MG
WATSON LABS 35MG
35MG
35MG
35MG
PLEGINE
WYETH AYERST 35MG
STATOBEX
TEVA 35MG
STATOBEX-G
TEVA 35MG
X-TROZINE
SHIRE RICHWOOD 35MG
35MG
35MG
35MG
35MG
6-247( of 322)
A083922 001
A085318 001
A085320 001
A085321 001
A085698 001
A083790 002
A083754 001
A087305 001
A085512 001
A083644 001
A083684 001
A083686 001
A083687 001
A084831 001
A084834 001
A084835 001
A086834 001 Sep 15, 1983
A084740 001
A084741 001
A084742 001
A084743 001
A085611 001
A085612 001
A083682 001
A084138 001
A084141 001
A085525 001
A085914 001
A086020 001
A083790 001
A085199 001
A085697 001
A085402 001
A085497 001
A085830 001
A086365 001
A086370 001
A083993 001
A085761 001
A085941 001 Jun 27, 1983
A083805 001
A084398 001
A084399 001
A085519 001
A086005 001
A086106 001
A085767 001
A085768 001
A085770 001
A085773 001
N012248 001
A086013 001
A085095 001
A086550 001
A086551 001
A086552 001
A086553 001
A086554 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-248( of 322)
PHENINDIONE
TABLET;ORAL
HEDULIN
SANOFI AVENTIS US 50MG N008767 002
PHENMETRAZINE HYDROCHLORIDE
TABLET;ORAL
PRELUDIN
BOEHRINGER INGELHEIM 25MG N010460 005
TABLET, EXTENDED RELEASE;ORAL
PRELUDIN
BOEHRINGER INGELHEIM 50MG N011752 004
75MG N011752 003
PHENPROCOUMON
TABLET;ORAL
LIQUAMAR
ORGANON USA INC 3MG N011228 001
PHENSUXIMIDE
CAPSULE;ORAL
MILONTIN
PARKE DAVIS 500MG N008855 004
PHENTERMINE HYDROCHLORIDE
CAPSULE;ORAL
FASTIN
GLAXOSMITHKLINE 30MG N017352 001
OBESTIN-30
FERNDALE LABS 30MG A087144 001
OBY-TRIM
SHIRE RICHWOOD 30MG A087764 001 Mar 18, 1982
ONA-MAST
MAST MM 30MG A086511 001
30MG A086516 001
PHENTERMINE HYDROCHLORIDE
ABC HOLDING 30MG A085411 001
ABLE 15MG A040497 001 Mar 13, 2003
30MG A040403 001 Aug 30, 2001
30MG A040427 001 Aug 30, 2001
CAMALL 15MG A086735 001
30MG A087226 001
DURAMED PHARMS BARR 30MG A088948 001 Apr 25, 1986
IVAX PHARMS 30MG A086329 001
MIKAH PHARMA 15MG A040460 001 Jan 14, 2003
30MG A040227 001 Jun 18, 1997
30MG A040448 001 Jan 22, 2003
37.5MG A040228 001 Jun 19, 1997
MUTUAL PHARM 37.5MG A040527 001 Oct 23, 2003
SANDOZ 30MG A087208 001
30MG A087223 001
37.5MG A088414 001 Oct 19, 1983
TEVA 30MG A086911 001
30MG A087126 001
30MG A087777 001 Nov 01, 1985
30MG A088612 001 Apr 04, 1984
30MG A088613 001 Apr 09, 1984
30MG A088614 001 Apr 09, 1984
TG UNITED INC 30MG A040083 001 Mar 07, 1997
TG UNITED LABS 18.75MG A088576 001 May 23, 1984
30MG A085417 001
30MG A086732 002
30MG A087215 001
37.5MG A087915 001 Dec 22, 1983
37.5MG A087918 001 Dec 22, 1983
37.5MG A087930 001 Oct 14, 1983
37.5MG A088610 001 Jun 04, 1984
37.5MG A088611 001 Jun 04, 1984
37.5MG A088625 001 Aug 23, 1984
USL PHARMA 30MG A084487 001 Apr 09, 1982
30MG A088430 001 Mar 27, 1984
30MG A088797 001 Dec 10, 1984
VITARINE 30MG A087202 001
30MG A087235 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-249( of 322)
PHENTERMINE HYDROCHLORIDE
CAPSULE;ORAL
PHENTERMINE HYDROCHLORIDE
WATSON LABS 30MG A086740 001 Mar 21, 1985
TABLET;ORAL
ONA-MAST
MAST MM 8MG A086260 001
PHENTERMINE HYDROCHLORIDE
ABLE 37.5MG A040402 001 Aug 30, 2001
ACTAVIS ELIZABETH 37.5MG A040276 001 Nov 25, 1998
IVAX PHARMS 8MG A085553 001
MIKAH PHARMA 37.5MG A040190 001 May 30, 1997
SANDOZ 8MG A085671 001
8MG A085689 001
SANDOZ INC 30MG A088605 001 Sep 28, 1987
TG UNITED LABS 8MG A083923 001
8MG A085319 001
37.5MG A087805 001 Dec 06, 1982
37.5MG A088596 001 Apr 04, 1984
USL PHARMA 8MG A083804 001
37.5MG A088910 001 Jul 17, 1985
37.5MG A088917 001 Jul 17, 1985
VITARINE 8MG A086453 001
8MG A086456 001
WATSON LABS 8MG A085739 001
TORA
SOLVAY 8MG A084035 001
WILPO
SANDOZ 8MG **Federal Register determination N012737 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PHENTERMINE RESIN COMPLEX
CAPSULE, EXTENDED RELEASE;ORAL
IONAMIN
UCB INC EQ 15MG BASE N011613 004
EQ 30MG BASE N011613 002
PHENTERMINE RESIN 30
QUANTUM PHARMICS EQ 30MG BASE A089120 001 Feb 04, 1988
PHENYL AMINOSALICYLATE
POWDER;ORAL
PHENY-PAS-TEBAMIN
PHARM RES ASSOC 50% N011695 002
TABLET;ORAL
PHENY-PAS-TEBAMIN
PHARM RES ASSOC 500MG N011695 003
PHENYLBUTAZONE
CAPSULE;ORAL
AZOLID
SANOFI AVENTIS US 100MG A087260 001
BUTAZOLIDIN
NOVARTIS 100MG N008319 009
PHENYLBUTAZONE
IVAX PHARMS 100MG A088218 001 Jun 24, 1983
MUTUAL PHARM 100MG A088994 001 Dec 04, 1985
SANDOZ 100MG A087774 001 Jun 16, 1982
WATSON LABS 100MG A087756 001 Dec 17, 1982
TABLET;ORAL
AZOLID
SANOFI AVENTIS US 100MG A087091 001
BUTAZOLIDIN
NOVARTIS 100MG N008319 008
PHENYLBUTAZONE
MUTUAL PHARM 100MG A088863 001 Dec 04, 1985
SANDOZ 100MG A084339 001
WATSON LABS 100MG A086151 001
100MG A087674 001 Apr 21, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PHENERGAN VC
ANI PHARMS
PHERAZINE VC
HALSEY
PROMETHAZINE VC PLAIN
CENCI 5MG/5ML;6.25MG/5ML
WOCKHARDT 5MG/5ML;6.25MG/5ML
PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE
5MG/5ML;6.25MG/5ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
5MG/5ML;6.25MG/5ML
SOLUTION/DROPS;OPHTHALMIC
PREFRIN-A
ALLERGAN
PHENYTOIN
SUSPENSION;ORAL
DILANTIN-30
PARKE DAVIS
PHENYTOIN
ACTAVIS MID ATLANTIC
PHENYTOIN SODIUM
CAPSULE;ORAL
DIPHENYLAN SODIUM
LANNETT
EXTENDED PHENYTOIN SODIUM
BARR
PLIVA
PHENYTEX
WATSON LABS
PHENYTOIN SODIUM
PHARMERAL
WATSON LABS
PROMPT PHENYTOIN SODIUM
IVAX SUB TEVA PHARMS
WATSON LABS
INJECTABLE;INJECTION
DILANTIN
PARKE DAVIS
PHENYTOIN SODIUM
FRESENIUS KABI USA
HOSPIRA
MARSAM PHARMS LLC
SMITH AND NEPHEW
SOLOPAK
WARNER CHILCOTT
WATSON LABS
PHYTONADIONE
INJECTABLE;INJECTION
AQUAMEPHYTON
BIOVAIL TECHNOLOGIES
KONAKION
ROCHE
PHYTONADIONE
GLAXOSMITHKLINE
VITAMIN K1
HOSPIRA
0.12%;0.1%
30MG/5ML
125MG/5ML
30MG PROMPT
100MG PROMPT
100MG EXTENDED
100MG EXTENDED
100MG EXTENDED
100MG PROMPT
100MG PROMPT
100MG PROMPT
100MG PROMPT
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
1MG/0.5ML
10MG/ML
1MG/0.5ML
10MG/ML
1MG/0.5ML
10MG/ML
10MG/ML
N008604 003
A088868 001
A088815 001
A088897 001
N007953 001
N008762 002
A089892 001
A080857 001
A080857 002
A040435 001
A089441 001
A088711 001
A085435 001
A085894 001
A080259 001
A080905 001
N010151 001
A089003 001
A089744 001
A089501 001
A089779 001
A088519 001
A088521 001
A088520 001
A089900 001
A085434 001
N012223 002
N012223 001
N011745 001
N011745 003
A084060 001
A084060 002
A087956 001
6-250( of 322)
Apr 02, 1984
Mar 02, 1987
Nov 22, 1985
Jan 04, 1985
Sep 25, 1992
Jun 20, 2003
Dec 18, 1986
Dec 21, 1984
May 31, 1985
Dec 18, 1987
Oct 13, 1987
Nov 27, 1992
Dec 19, 1984
Dec 18, 1984
Dec 17, 1984
Mar 30, 1990
Jul 25, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-251( of 322)
PILOCARPINE
INSERT, EXTENDED RELEASE;OPHTHALMIC
OCUSERT PILO-20
AKORN 5MG N017431 001
OCUSERT PILO-40
AKORN 11MG N017548 001
PINACIDIL
CAPSULE, EXTENDED RELEASE;ORAL
PINDAC
LEO PHARM 12.5MG
25MG
N019456 001
N019456 002
Dec 28, 1989
Dec 28, 1989
PINDOLOL
TABLET;ORAL
PINDOLOL
IVAX SUB TEVA PHARMS
MUTUAL PHARM
MYLAN PHARMS INC
NOSTRUM LABS
PUREPAC PHARM
SANDOZ
TEVA
WATSON LABS
VISKEN
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
5MG
10MG
10MG
5MG
10MG
A073687 001
A073687 002
A074063 001
A074063 002
A074013 001
A074018 001
A074474 001
A074474 002
A074125 001
A074125 002
A073608 001
A073609 001
A073661 001
A074123 001
A073661 002
A074123 002
A074437 001
A074437 002
Feb 26, 1993
Feb 26, 1993
Jan 27, 1994
Jan 27, 1994
Sep 24, 1992
Sep 24, 1992
Oct 28, 1996
Oct 28, 1996
Apr 28, 1993
Apr 28, 1993
Mar 29, 1993
Mar 29, 1993
Oct 31, 1993
Apr 17, 1997
Oct 31, 1993
Apr 17, 1997
Feb 27, 1995
Feb 27, 1995
NOVARTIS 5MG
10MG
N018285 001
N018285 002
Sep 03, 1982
Sep 03, 1982
PIPECURONIUM BROMIDE
INJECTABLE;INJECTION
ARDUAN
ORGANON USA INC 10MG/VIAL N019638 001 Jun 26, 1990
PIPERACETAZINE
TABLET;ORAL
QUIDE
DOW PHARM 10MG N013615 001
25MG N013615 002
PIPERACILLIN SODIUM
INJECTABLE;INJECTION
PIPRACIL
WYETH PHARMS INC EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 3GM BASE/VIAL
EQ 3GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 40GM BASE/VIAL
A062750 001
N050545 002
A062750 002
N050545 003
A062750 003
N050545 004
N050545 006
Oct 13, 1987
Oct 13, 1987
Oct 13, 1987
Sep 30, 1985
PIPERAZINE CITRATE
SYRUP;ORAL
ANTEPAR
GLAXOSMITHKLINE
BRYREL
EQ 500MG BASE/5ML N009102 001
SANOFI AVENTIS US
MULTIFUGE
EQ 500MG BASE/5ML N017796 001
BLULINE
PIPERAZINE CITRATE
EQ 500MG BASE/5ML N009452 001
ALPHARMA US PHARMS
LANNETT
LUITPOLD
VERMIDOL
EQ 500MG BASE/5ML
EQ 500MG BASE/5ML
EQ 500MG BASE/5ML
A080774 001
A080963 001
A080671 001
SOLVAY EQ 500MG BASE/5ML A080992 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-252( of 322)
PIPERAZINE CITRATE
TABLET;ORAL
ANTEPAR
GLAXOSMITHKLINE EQ 500MG BASE N009102 003
PIPERAZINE CITRATE
IMPAX LABS EQ 250MG BASE A080874 001
PIPOBROMAN
TABLET;ORAL
VERCYTE
ABBOTT 10MG N016245 001
25MG N016245 002
PIRBUTEROL ACETATE
AEROSOL, METERED;INHALATION
MAXAIR
MEDICIS EQ 0.2MG BASE/INH N019009 001 Dec 30, 1986
PIROXICAM
CAPSULE;ORAL
PIROXICAM
EGIS 10MG A074808 001 Jul 08, 1997
20MG A074808 002 Jul 08, 1997
IVAX SUB TEVA PHARMS 10MG A074148 001 Jun 03, 1996
20MG A074148 002 Jun 03, 1996
MUTUAL PHARM 20MG A073536 001 Mar 12, 1993
MYLAN 10MG A074043 001 Sep 22, 1992
20MG A074043 002 Sep 22, 1992
ROXANE 10MG A073651 001 Feb 26, 1993
20MG A073651 002 Feb 26, 1993
SCS 10MG A074036 001 May 29, 1992
20MG A074036 002 May 29, 1992
TEVA 10MG A073637 001 Jan 28, 1994
20MG A073638 001 Jan 28, 1994
TEVA PHARMS 10MG A074103 001 Aug 28, 1992
20MG A074103 002 Aug 28, 1992
PLICAMYCIN
INJECTABLE;INJECTION
MITHRACIN
PFIZER 2.5MG/VIAL N050109 001
POLYESTRADIOL PHOSPHATE
INJECTABLE;INJECTION
ESTRADURIN
WYETH AYERST 40MG/AMP N010753 001
POLYETHYLENE GLYCOL 3350
FOR SOLUTION;ORAL
POLYETHYLENE GLYCOL 3350
PADDOCK LLC 17GM/SCOOPFUL A090567 001 Oct 15, 2009
TEVA PHARMS 17GM/SCOOPFUL A077445 001 May 04, 2006
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
FOR SOLUTION;ORAL
CLENZ-LYTE
PADDOCK LLC 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A090769 001 Jun 07, 2010
BOT;22.74GM/BOT
SOLUTION;ORAL
OCL
HOSPIRA 6GM/100ML;75MG/100ML;168MG/100ML;146MG/ N019284 001 Apr 30, 1986
100ML;1.29GM/100ML
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
ANHYDROUS
FOR SOLUTION;ORAL
COLYTE
MEDA PHARMS 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKE N018983 005 Oct 26, 1984
T;2.92GM/PACKET;11.36GM/PACKET
227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC N018983 004 Oct 26, 1984
KET;5.53GM/PACKET;21.5GM/PACKET
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ N018983 007 Jun 12, 1987
BOT;22.72GM/BOT
360GM/PACKET;4.47GM/PACKET;10.08GM/PACK N018983 006 Oct 26, 1984
ET;8.76GM/PACKET;34.08GM/PACKET
COLYTE-FLAVORED
MEDA PHARMS 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G N018983 008 Nov 14, 1991
M/BOT;21.5GM/BOT
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-253( of 322)
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
ANHYDROUS
FOR SOLUTION;ORAL
COLYTE-FLAVORED
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/
BOT;22.72GM/BOT
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
PADDOCK LLC
FOR SUSPENSION;ORAL
CO-LAV
BOCA PHARMA LLC
COLOVAGE
DYNAPHARM
E-Z-EM PREP LYTE
E Z EM
GLYCOPREP
GOLDLINE
GO-EVAC
BOCA PHARMA LLC
PEG-LYTE
SANDOZ
POLYMYXIN B SULFATE
INJECTABLE;INJECTION
AEROSPORIN
GLAXOSMITHKLINE
POWDER;FOR RX COMPOUNDING
POLY-RX
X GEN PHARMS
POLYMYXIN B SULFATE
PADDOCK LLC
POLYTHIAZIDE
TABLET;ORAL
RENESE
PFIZER
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/
BOT;22.72GM/BOT
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/
BOT;22.72GM/BOT
227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC
KET;5.53GM/PACKET;21.5GM/PACKET
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
BOT;22.74GM/BOT
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
BOT;22.74GM/BOT
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
BOT;22.74GM/BOT
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
BOT;22.74GM/BOT
EQ 500,000 U BASE/VIAL
100,000,000 UNITS/BOT
100,000,000 UNITS/BOT
1MG
2MG
4MG
POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
MINIZIDE
PFIZER
POLYTHIAZIDE; RESERPINE
TABLET;ORAL
RENESE-R
PFIZER
POTASSIUM AMINOSALICYLATE
CAPSULE;ORAL
PASKALIUM
GLENWOOD
POWDER;ORAL
POTASSIUM AMINOSALICYLATE
HEXCEL
TABLET;ORAL
PASKALIUM
GLENWOOD
POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
K-LEASE
SAVAGE LABS
POTASSIUM CHLORIDE
NESHER PHARMS
TEVA
0.5MG;EQ 1MG BASE
0.5MG;EQ 2MG BASE
0.5MG;EQ 5MG BASE
2MG;0.25MG
500MG
100%
1GM
8MEQ
10MEQ
10MEQ
8MEQ
N018983 009 Nov 14, 1991
A090712 001 Feb 25, 2010
A073428 001 Jan 28, 1992
A071320 001 Apr 20, 1988
A071278 001 Nov 21, 1988
A072319 001 Dec 23, 1988
A073433 001 Apr 28, 1992
A073098 001 Aug 31, 1993
A062036 001
A061578 001
A062455 001 Jul 27, 1983
N012845 001
N012845 002
N012845 003
N017986 001
N017986 002
N017986 003
N013636 001
N009395 004
A080098 001
N009395 003
A073398 001 Jan 28, 1992
A072427 001 Mar 28, 1990
A070980 001 Feb 17, 1987
A073531 001 Apr 26, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-254( of 322)
POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
POTASSIUM CHLORIDE
10MEQ A073532 001 Apr 26, 1996
FOR SUSPENSION, EXTENDED RELEASE;ORAL
MICRO-K LS
KV PHARM
INJECTABLE;INJECTION
POTASSIUM CHLORIDE
ABRAXIS PHARM
AKORN
BAXTER HLTHCARE
FRESENIUS KABI USA
GD SEARLE LLC
HOSPIRA
LILLY
LUITPOLD
MILES
PHARMA SERVE NY
WATSON LABS
TABLET, EXTENDED RELEASE;ORAL
K+10
FUTURE PAK
K+8
FUTURE PAK
K-TAB
ABBVIE
KAON CL
SAVAGE LABS
KAON CL-10
SAVAGE LABS
KLOTRIX
APOTHECON
POTASSIUM CHLORIDE
ABBVIE
COPLEY PHARM
NESHER PHARMS
SCHERING
SLOW-K
NOVARTIS
TEN-K
NOVARTIS
20MEQ/PACKET N019561 003 Aug 26, 1988
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
1MEQ/ML
2MEQ/ML
2MEQ/ML
3MEQ/ML
3MEQ/ML
4MEQ/ML
1MEQ/ML
1MEQ/ML
1.5MEQ/ML
2MEQ/ML
2.4MEQ/ML
3.2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
1MEQ/ML
2MEQ/ML
3MEQ/ML
4MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
3MEQ/ML
A080204 001
A084290 001
A086713 001
A086714 001
A087787 001
A087885 001
A088286 001
A080203 001
A087817 001
A086219 001
A086219 002
A086220 002
A086219 003
A086220 001
A086219 004
A080205 003
A083345 003
A083345 001
A083345 002
A080205 004
A080205 005
N007865 002
A080221 001
A080736 001
A087584 001
A087585 001
A080195 002
A080195 001
A080195 003
A080195 004
A086297 001
A087362 001
A086208 001
A089163 001
A089421 001
A086210 001
Apr 20, 1982
Feb 03, 1983
Sep 05, 1985
Oct 20, 1982
Mar 08, 1983
Mar 10, 1988
Jan 02, 1987
10MEQ A070999 001 Oct 22, 1987
8MEQ A070998 001 Jan 25, 1993
10MEQ N018279 001
6.7MEQ N017046 001
10MEQ N017046 002
10MEQ N017850 001
8MEQ
8MEQ
20MEQ
10MEQ
20MEQ
N018279 002
A070618 001
A076044 001
N019439 002
N019439 001
Aug 01, 1988
Sep 09, 1987
Apr 05, 2002
Jun 13, 1986
Jun 13, 1986
8MEQ N017476 002
10MEQ N019381 001 Apr 16, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-255( of 322)
POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 37MG/100ML;900MG/100ML N019708 001 Sep 29, 1989
POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 75MG/100ML;900MG/100ML N019708 002 Sep 29, 1989
POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 110MG/100ML;900MG/100ML N019708 003 Sep 29, 1989
POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 220MG/100ML;900MG/100ML N019708 005 Sep 29, 1989
POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 300MG/100ML;900MG/100ML N019708 006 Sep 29, 1989
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
B BRAUN 75MG/100ML;900MG/100ML N018722 001 Nov 09, 1982
BAXTER HLTHCARE 75MG/100ML;900MG/100ML N017648 004
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN 150MG/100ML;900MG/100ML N018722 002 Nov 09, 1982
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
B BRAUN 220MG/100ML;900MG/100ML N018722 003 Nov 09, 1982
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 300MG/100ML;900MG/100ML N018722 004 Nov 09, 1982
POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE
INJECTABLE;INJECTION
THAM-E
HOSPIRA 370MG/VIAL;1.75GM/VIAL;36GM/VIAL N013025 001
POTASSIUM CITRATE
FOR SOLUTION;ORAL
POTASSIUM CITRATE
NOVA K 10MEQ/PACKET **Federal Register N019647 002 Oct 13, 1988
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
20MEQ/PACKET **Federal Register N019647 001 Oct 13, 1988
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
POTASSIUM IODIDE
SOLUTION;ORAL
POTASSIUM IODIDE
ROXANE 1GM/ML N018551 001 Feb 19, 1982
TABLET;ORAL
THYRO-BLOCK
MEDPOINTE PHARM HLC 130MG N018307 001
POTASSIUM PERCHLORATE
CAPSULE;ORAL
PERCHLORACAP
MALLINCKRODT 200MG N017551 001
POVIDONE-IODINE
SOLUTION;TOPICAL
E-Z PREP
CLINIPAD 10% N019382 001 Jul 25, 1989
SPONGE;TOPICAL
E-Z PREP
CLINIPAD 5% N019382 002 Jul 25, 1989
E-Z PREP 220
CLINIPAD 5% N019382 003 Jul 25, 1989
PRALIDOXIME CHLORIDE
INJECTABLE;INJECTION
PRALIDOXIME CHLORIDE
BAXTER HLTHCARE CORP 300MG/ML N018799 001 Dec 13, 1982
TABLET;ORAL
PROTOPAM CHLORIDE
WYETH AYERST 500MG N014122 002
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL
MIRAPEX
BOEHRINGER INGELHEIM 1.25MG N020667 004 Jul 01, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-256( of 322)
PRAMLINTIDE ACETATE
INJECTABLE;SUBCUTANEOUS
SYMLIN
AMYLIN PHARMS LLC EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) N021332 001 Mar 16, 2005
PRAVASTATIN SODIUM
TABLET;ORAL
PRAVASTATIN SODIUM
PLIVA HRVATSKA DOO 10MG A077730 001 Nov 21, 2006
20MG A077730 002 Nov 21, 2006
30MG A077730 003 Nov 21, 2006
40MG A077730 005 Nov 21, 2006
RANBAXY LABS LTD 10MG A076445 001 Apr 23, 2007
20MG A076445 002 Apr 23, 2007
40MG A076445 003 Apr 23, 2007
80MG A076445 004 Apr 23, 2007
SANDOZ 10MG A076397 003 Oct 23, 2006
20MG A076397 002 Oct 23, 2006
40MG A076397 001 Oct 23, 2006
80MG A077491 001 Feb 11, 2008
PRAZEPAM
CAPSULE;ORAL
CENTRAX
PARKE DAVIS 5MG N018144 001
10MG N018144 002
20MG N018144 003 May 10, 1982
PRAZEPAM
USL PHARMA 5MG A070427 001 Nov 06, 1987
10MG A070428 001 Nov 06, 1987
TABLET;ORAL
CENTRAX
PARKE DAVIS 10MG N017415 001
PRAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
PRAZOSIN HYDROCHLORIDE
AM THERAP EQ 1MG BASE A072782 001 May 16, 1989
EQ 2MG BASE A072783 001 May 16, 1989
EQ 5MG BASE A072784 001 May 16, 1989
CLONMEL HLTHCARE EQ 1MG BASE A072705 001 May 16, 1989
EQ 2MG BASE A072706 001 May 16, 1989
EQ 5MG BASE A072707 001 May 16, 1989
PUREPAC PHARM EQ 1MG BASE A072991 001 May 16, 1989
EQ 2MG BASE A072921 001 May 16, 1989
EQ 5MG BASE A072992 001 May 16, 1989
SANDOZ EQ 1MG BASE A072576 001 May 16, 1989
EQ 2MG BASE A072577 001 May 16, 1989
EQ 5MG BASE A072578 001 May 16, 1989
WATSON LABS EQ 1MG BASE A072352 001 May 16, 1989
EQ 2MG BASE A072333 001 May 16, 1989
EQ 5MG BASE A072609 001 May 16, 1989
TABLET, EXTENDED RELEASE;ORAL
MINIPRESS XL
PFIZER 2.5MG N019775 001 Jan 29, 1992
5MG N019775 002 Jan 29, 1992
PREDNISOLONE
CREAM;TOPICAL
METI-DERM
SCHERING 0.5% N010209 002
SYRUP;ORAL
PREDNISOLONE
APOTEX INC 5MG/5ML A040570 001 Aug 25, 2005
15MG/5ML A040571 001 Aug 25, 2005
IVAX SUB TEVA PHARMS 15MG/5ML A040287 001 May 28, 1999
NESHER PHARMS 5MG/5ML A040423 001 Oct 22, 2001
15MG/5ML A040364 001 Apr 10, 2002
TEVA PHARMS 15MG/5ML A040322 001 Jan 19, 2000
WE PHARMS 15MG/5ML A040192 001 May 28, 1998
PRELONE
MURO 5MG/5ML A089654 001 Jan 17, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-257( of 322)
A080304 003
A080304 002
A080304 001
N009987 004
A083941 001
A084426 002
A083675 001
A080625 001
A084439 001
A084439 002
A084439 003
A080562 001
A080562 002
A080326 001
A080780 001
A080748 001
A080378 001
A080531 002
A080307 001
A080351 001
A080351 002
A084542 001
A080322 001
A080325 001
A080211 001
A080327 002
A080339 001
A084773 001
A080358 001
A080358 002
A080358 003
A088892 001 Feb 26, 1985
A085170 001
A080398 001
A087987 001 Jan 18, 1983
A080236 001
A080534 001
A085085 002
A085415 001
A085416 001
A080324 001
A080342 001
N009996 001
N010255 002
A083032 001
A084492 001
A083738 001
A083738 002
A084717 001
A084717 002
A083398 001
A083654 001
A083767 001
A083764 001
A085781 001
N011446 001
N022067 001 Jan 17, 2008
PREDNISOLONE
TABLET;ORAL
CORTALONE
HALSEY
DELTA-CORTEF
PHARMACIA AND UPJOHN
FERNISOLONE-P
FERNDALE LABS
PREDNISOLONE
BARR
BUNDY
ELKINS SINN
EVERYLIFE
FERRANTE
HEATHER
IMPAX LABS
INWOOD LABS
IVAX SUB TEVA PHARMS
LANNETT
MARSHALL PHARMA
PANRAY
PERRIGO
PHOENIX LABS NY
PUREPAC PHARM
PVT FORM
ROXANE
SANDOZ
SPERTI
SUPERPHARM
TABLICAPS
TEVA
UDL
VALEANT PHARM INTL
VITARINE
WATSON LABS
WEST WARD
WHITEWORTH TOWN PLSN
STERANE
PFIZER
PREDNISOLONE ACETATE
INJECTABLE;INJECTION
METICORTELONE
SCHERING
PREDNISOLONE ACETATE
AKORN
BEL MAR
CENT PHARMS
WATSON LABS
STERANE
PFIZER
SUSPENSION;ORAL
FLO-PRED
TARO
1MG
2.5MG
5MG
5MG
5MG
5MG
5MG
5MG
1MG
2.5MG
5MG
2.5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
1MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
1MG
2.5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
25MG/ML
25MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG/ML
25MG/ML
40MG/ML
50MG/ML
50MG/ML
25MG/ML
EQ 5MG BASE/5ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PREDNISOLONE ACETATE
SUSPENSION/DROPS;OPHTHALMIC
ECONOPRED
ALCON 0.125%
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
OINTMENT;OPHTHALMIC
CETAPRED
ALCON
METIMYD
SCHERING
PREDSULFAIR
PHARMAFAIR
VASOCIDIN
NOVARTIS
SUSPENSION;OPHTHALMIC
ISOPTO CETAPRED
ALCON
SUSPENSION/DROPS;OPHTHALMIC
METIMYD
SCHERING
PREDAMIDE
AKORN
PREDSULFAIR
PHARMAFAIR
PREDSULFAIR II
PHARMAFAIR
SULPHRIN
BAUSCH AND LOMB
PREDNISOLONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
HYDELTRASOL
MERCK
PREDNISOLONE SODIUM PHOSPHATE
WATSON LABS EQ 20MG PHOSPHATE/ML
OINTMENT;OPHTHALMIC, OTIC
HYDELTRASOL
MERCK EQ 0.25% PHOSPHATE
SOLUTION;ORAL
PREDNISOLONE SODIUM PHOSPHATE
0.25%;10%
0.5%;10%
0.5%;10%
0.5%;10%
0.25%;10%
0.5%;10%
0.5%;10%
0.5%;10%
0.2%;10%
0.5%;10%
EQ 20MG PHOSPHATE/ML
NESHER PHARMS
PHARM ASSOC
VINTAGE PHARMS
WE PHARMS
SOLUTION/DROPS;OPHTHALMIC
INFLAMASE FORTE
NOVARTIS
INFLAMASE MILD
NOVARTIS
METRETON
SCHERING
PREDAIR
PHARMAFAIR
PREDAIR FORTE
PHARMAFAIR
EQ 5MG BASE/5ML
EQ 15MG BASE/5ML
EQ 5MG BASE/5ML
EQ 5MG BASE/5ML
EQ 5MG BASE/5ML
EQ 15MG BASE/5ML
EQ 0.9% PHOSPHATE
EQ 0.11% PHOSPHATE
EQ 0.5% PHOSPHATE
EQ 0.11% PHOSPHATE
EQ 0.9% PHOSPHATE
PREDNISOLONE SODIUM PHOSPHATE
AKORN
ALCON PHARMS LTD
BAUSCH AND LOMB
SOLA BARNES HIND
EQ 0.11% PHOSPHATE
EQ 0.9% PHOSPHATE
EQ 0.11% PHOSPHATE
EQ 0.9% PHOSPHATE
EQ 0.11% PHOSPHATE
EQ 0.11% PHOSPHATE
EQ 0.9% PHOSPHATE
EQ 0.9% PHOSPHATE
EQ 0.9% PHOSPHATE
6-258( of 322)
N017468 001
A087771 001 Aug 06, 1993
N010210 002 Sep 09, 1984
A088032 001 Apr 15, 1983
A088791 001 Oct 05, 1984
A087547 001
N010210 001
A088059 001 Jul 29, 1983
A088007 001 Apr 19, 1983
A088837 001 Dec 24, 1985
A088089 001 Dec 28, 1982
N011583 002
A080517 001
N011028 001
A076982 001 May 24, 2005
A076988 001 May 24, 2005
A076123 001 Dec 23, 2002
A078416 001 Oct 31, 2007
A075181 001 Dec 23, 2002
A075250 001 Jul 12, 2002
A080751 002
A080751 001
A083834 001
A088415 001 Feb 29, 1984
A088165 001 Mar 28, 1983
A083358 001
A083358 002
A081043 001 Oct 24, 1991
A081044 001 Oct 24, 1991
A040065 001 Jul 29, 1994
A084171 001
A084168 001
A084169 001
A084172 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
SOLUTION/DROPS;OPHTHALMIC
SULSTER
AKORN
PREDNISOLONE TEBUTATE
INJECTABLE;INJECTION
HYDELTRA-TBA
MERCK
PREDNISOLONE TEBUTATE
WATSON LABS
PREDNISONE
SOLUTION;ORAL
PREDNISONE
WOCKHARDT
SYRUP;ORAL
LIQUID PRED
MURO
TABLET;ORAL
CORTAN
HALSEY
DELTA-DOME
BAYER PHARMS
DELTASONE
PHARMACIA AND UPJOHN
FERNISONE
FERNDALE LABS
METICORTEN
SCHERING
ORASONE
SOLVAY
PARACORT
PARKE DAVIS
PREDNICEN-M
SCHWARZ PHARMA
PREDNISONE
AM THERAP
AMNEAL PHARMS NY
BUNDY
DURAMED PHARMS BARR
ELKINS SINN
EVERYLIFE
FERRANTE
HALSEY
HEATHER
IMPAX LABS
INWOOD LABS
EQ 0.23% PHOSPHATE;10%
20MG/ML
20MG/ML
5MG/5ML
5MG/5ML
20MG
5MG
2.5MG
5MG
10MG
20MG
50MG
5MG
1MG
5MG
1MG
5MG
10MG
20MG
50MG
5MG
5MG
5MG
10MG
20MG
5MG
10MG
20MG
5MG
5MG
10MG
20MG
5MG
20MG
1MG
2.5MG
5MG
2.5MG
5MG
5MG
5MG
10MG
20MG
20MG
50MG
5MG
1MG
2.5MG
5MG
6-259( of 322)
A074511 001 Jul 30, 1996
N010562 001
A083362 001 Feb 17, 1984
A089726 001 Aug 02, 1988
A087611 002 Sep 07, 1982
A087480 001
A080293 001
N009986 005
N009986 002
N009986 006
N009986 007
N009986 008
A083364 001
N009766 002
N009766 001
A083009 001
A083009 002
A083009 003
A083009 004
A085999 001
N010962 002
A084655 001
A089387 001 Nov 06, 1986
A089388 001 Nov 06, 1986
A089389 001 Nov 06, 1986
A089597 001 Oct 05, 1987
A089598 001 Oct 05, 1987
A089599 001 Oct 05, 1987
A083676 001
A088394 001 Oct 04, 1983
A088395 001 Oct 04, 1983
A088396 001 Oct 04, 1983
A080491 001
A085811 001
A084440 001
A084440 002
A084440 003
A080563 001
A080563 002
A080300 001
A080320 001
A084341 001
A084417 001
A085543 001
A086946 001
A080782 001
A080328 001
A080306 001
A080279 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-260( of 322)
PREDNISONE
TABLET;ORAL
PREDNISONE
IVAX SUB TEVA PHARMS 5MG A080283 001
10MG A084133 001
20MG A084134 001
KV PHARM 5MG A084236 001
LANNETT 5MG A080514 001
20MG A084275 001
LEDERLE 5MG A086968 001
MARSHALL PHARMA 5MG A080301 001
MUTUAL PHARM 5MG A080701 001
10MG A086595 001
20MG A084634 001
50MG A086596 001
NYLOS 5MG A085115 001
PANRAY 1MG A080350 001
2.5MG A080350 002
5MG A080350 003
PERRIGO 5MG A083059 001
PHARMAVITE 5MG A084662 002
PHOENIX LABS NY 5MG A080321 001
20MG A083807 001
PUREPAC PHARM 5MG A080353 001
10MG A086062 001
20MG A086061 001
PVT FORM 20MG A085151 001
REXALL 5MG A080232 001
ROXANE 20MG N017109 001
SANDOZ
25MG
5MG
A087833 001
A080336 002
May 04, 1982
5MG A084774 001
10MG A089983 001 Jan 12, 1989
20MG A085813 001
50MG A089984 001 Jan 12, 1989
SCHERER LABS 5MG A080371 001
SPERTI 1MG A080359 001
2.5MG A080359 002
5MG A080359 003
SUPERPHARM 5MG A088865 001 Oct 25, 1984
10MG A088866 001 Oct 25, 1984
20MG A088867 001 Oct 25, 1984
TEVA 5MG A080397 001
UDL 5MG A087984 001 Jan 18, 1983
10MG A087985 001 Jan 18, 1983
20MG A087986 001 Jan 18, 1983
UPSHER SMITH 5MG A087471 001
20MG A087470 001
VALEANT PHARM INTL 5MG A080237 001
VANGARD 5MG A087682 001 Jan 15, 1982
20MG A087701 001 Jan 15, 1982
VITARINE 5MG A080334 001
5MG A080506 001
WATSON LABS 5MG A085084 002
10MG A087773 001 Jul 13, 1982
20MG A086813 001
50MG A086867 001
50MG A087772 001 Jul 13, 1982
WHITEWORTH TOWN PLSN 2.5MG A084913 001
5MG A080343 001
10MG A089028 001 Jul 24, 1986
20MG A084913 002
SERVISONE
LEDERLE 5MG A080223 001
PRILOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CITANEST
ASTRAZENECA 1% N014763 004
2% N014763 005
3% N014763 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PRILOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CITANEST PLAIN
ASTRAZENECA
CITANEST PLAIN DENTAL
DENTSPLY PHARM
PRIMIDONE
SUSPENSION;ORAL
MYSOLINE
NURO PHARMA
TABLET;ORAL
PRIMIDONE
DR REDDYS LABS LTD
WATSON LABS
WEST WARD
PROBENECID
TABLET;ORAL
BENEMID
MERCK
PROBENECID
IVAX SUB TEVA PHARMS
LEDERLE
WATSON LABS
PROBUCOL
TABLET;ORAL
LORELCO
SANOFI AVENTIS US
PROCAINAMIDE HYDROCHLORIDE
CAPSULE;ORAL
PROCAINAMIDE HYDROCHLORIDE
ASCOT
IVAX SUB TEVA PHARMS
LANNETT
LEDERLE
ROXANE
SANDOZ
VANGARD
WATSON LABS
PROCAN
PARKE DAVIS
PROCAPAN
PANRAY
PRONESTYL
APOTHECON
4%
4%
250MG/5ML
50MG
250MG
250MG
50MG
500MG
500MG
500MG
500MG
250MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
500MG
250MG
375MG
500MG
250MG
500MG
250MG
375MG
500MG
250MG
500MG
250MG
250MG
250MG
375MG
375MG
500MG
500MG
500MG
250MG
375MG
500MG
250MG
250MG
375MG
500MG
6-261( of 322)
N014763 007
N021382 001
N010401 001
A040862 001 Oct 03, 2008
A040862 002 Oct 03, 2008
A085052 001
A040667 001 Jul 27, 2006
N007898 004
A083740 001 May 09, 1984
A086917 001
A086150 002 Apr 23, 1982
N017535 001
N017535 002 Jul 06, 1988
A087542 001 Jan 08, 1982
A087697 001 Mar 01, 1983
A087543 001 Jan 08, 1982
A084604 001
A084595 001
A084606 001
A083693 001
A084696 001
A086942 001
A086952 001
A086943 001
A088989 001 Apr 26, 1985
A088990 001 Apr 26, 1985
A089219 001 Jul 01, 1986
A089220 001 Jul 01, 1986
A089221 001 Jul 01, 1986
A087643 001 Jun 01, 1982
A087875 001 Jun 01, 1982
A083287 001
A083795 001
A085167 001
A084403 001
A087020 001
A084280 001
A084357 001
A087021 001
A085804 001
A087502 001
A085079 001
A083553 002
N007335 001
N007335 004
N007335 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-262( of 322)
PROCAINAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
PROCAINAMIDE HYDROCHLORIDE
ABRAXIS PHARM 100MG/ML A089415 001 Nov 17, 1986
500MG/ML A089416 001 Nov 17, 1986
HIKMA MAPLE 100MG/ML A089029 001 Apr 17, 1986
500MG/ML A089030 001 Apr 17, 1986
HOSPIRA 500MG/ML A089537 001 Aug 25, 1987
PHARMAFAIR 100MG/ML A088824 001 Nov 20, 1985
500MG/ML A088830 001 Nov 20, 1985
SMITH AND NEPHEW 100MG/ML A088530 001 Mar 04, 1985
500MG/ML A088531 001 Mar 04, 1985
SOLOPAK 500MG/ML A088532 001 Mar 04, 1985
WARNER CHILCOTT 100MG/ML A089528 001 May 03, 1988
500MG/ML A089529 001 May 03, 1988
WATSON LABS 100MG/ML A087079 001
500MG/ML A087080 001
PRONESTYL
APOTHECON 100MG/ML N007335 002
500MG/ML N007335 005
TABLET;ORAL
PRONESTYL
APOTHECON 250MG N017371 001
375MG N017371 002
500MG N017371 003
TABLET, EXTENDED RELEASE;ORAL
PROCAINAMIDE HYDROCHLORIDE
COPLEY PHARM 1GM A040111 001 Dec 13, 1996
500MG A088974 001 Jul 22, 1985
750MG A089438 001 Mar 23, 1987
INWOOD LABS 500MG A089840 001 Mar 06, 1989
PLIVA 250MG A088958 001 Dec 02, 1985
500MG A088959 001 Dec 02, 1985
SANDOZ 250MG A089369 001 Aug 14, 1987
500MG A089284 001 Jun 23, 1986
500MG A089370 001 Jan 09, 1987
750MG A089371 001 Aug 14, 1987
WATSON LABS 1GM A089520 001 Jan 15, 1987
250MG A088533 001 Dec 03, 1984
250MG A089026 001 Oct 22, 1985
500MG A088534 001 Dec 03, 1984
500MG A089027 001 Oct 22, 1985
750MG A088535 001 Nov 03, 1984
750MG A089042 001 Oct 22, 1985
PROCAN SR
PARKE DAVIS 250MG A086468 001
PARKEDALE 1GM A088489 001 Jan 16, 1985
500MG A086065 001
750MG A087510 001 Apr 01, 1982
PROCANBID
KING PHARMS 1GM N020545 002 Jan 31, 1996
500MG N020545 001 Jan 31, 1996
PRONESTYL-SR
APOTHECON 500MG A087361 001
PROCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
NOVOCAIN
HOSPIRA 1% A085362 003
2% A085362 004
10% A086797 001
PROCAINE HYDROCHLORIDE
ABRAXIS PHARM 1% A080384 002
1% A080421 001
2% A080384 003
2% A080421 002
BEL MAR 1% A080711 001
2% A080756 001
ELKINS SINN 1% A083315 001
2% A083315 002
GD SEARLE LLC 1% A086202 001
2% A086202 002
HOSPIRA 1% A080416 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PROCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
PROCAINE HYDROCHLORIDE
2%
MILES 1%
2%
WATSON LABS 1%
1%
2%
2%
PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE
INJECTABLE;INJECTION
ACHROMYCIN
LEDERLE 40MG/VIAL;100MG/VIAL
40MG/VIAL;250MG/VIAL
TETRACYN
PFIZER 40MG/VIAL;100MG/VIAL
40MG/VIAL;250MG/VIAL
PROCAINE MERETHOXYLLINE; THEOPHYLLINE
INJECTABLE;INJECTION
DICURIN PROCAINE
LILLY
PROCHLORPERAZINE
SUPPOSITORY;RECTAL
COMPAZINE
GLAXOSMITHKLINE
PROCHLORPERAZINE
ABLE
PROCHLORPERAZINE EDISYLATE
CONCENTRATE;ORAL
COMPAZINE
GLAXOSMITHKLINE
PROCHLORPERAZINE
ALPHARMA US PHARMS
PROCHLORPERAZINE EDISYLATE
MORTON GROVE
INJECTABLE;INJECTION
COMPAZINE
GLAXOSMITHKLINE
PROCHLORPERAZINE
BAXTER HLTHCARE
PROCHLORPERAZINE EDISYLATE
HIKMA MAPLE
HOSPIRA
MARSAM PHARMS LLC
SMITH AND NEPHEW
TEVA PARENTERAL
WATSON LABS
WYETH AYERST
SYRUP;ORAL
COMPAZINE
GLAXOSMITHKLINE
PROCHLORPERAZINE EDISYLATE
ALPHARMA US PHARMS
MORTON GROVE
PROCHLORPERAZINE MALEATE
100MG/ML;50MG/ML
2.5MG
5MG
25MG
2.5MG
5MG
25MG
EQ 10MG BASE/ML
EQ 10MG BASE/ML
EQ 10MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/5ML
EQ 5MG BASE/5ML
EQ 5MG BASE/5ML
CAPSULE, EXTENDED RELEASE;ORAL
COMPAZINE
GLAXOSMITHKLINE EQ 10MG BASE
EQ 10MG BASE
EQ 15MG BASE
EQ 15MG BASE
EQ 30MG BASE
EQ 75MG BASE
6-263( of 322)
A080416 002
A080415 001
A080415 002
A080658 001
A083535 001
A080658 002
A083535 002
N050276 001
N050276 003
A060285 002
A060285 003
N008869 001
N011127 003
N011127 001
N011127 002
A040407 001 Jul 11, 2001
A040407 002 Jul 11, 2001
A040407 003 Jul 11, 2001
N011276 001
A087153 001 Jun 08, 1982
A088598 001 Oct 25, 1984
N010742 002
A087759 001 Oct 01, 1982
A089523 001 May 03, 1988
A089703 001 Apr 07, 1988
A089675 001 Dec 05, 1988
A089251 001 Dec 04, 1986
A040505 001 May 30, 2003
A089530 001 Jul 08, 1987
A089605 001 Jul 08, 1987
A089606 001 Jul 08, 1987
A086348 001
N011188 001
A087154 001 Sep 01, 1982
A088597 001 Oct 25, 1984
N011000 001
N021019 001 Oct 06, 1999
N011000 002
N021019 002 Oct 06, 1999
N011000 003
N011000 004
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PROCHLORPERAZINE MALEATE
TABLET;ORAL
COMPAZINE
GLAXOSMITHKLINE
PROCHLORPERAZINE
WATSON LABS
PROCHLORPERAZINE MALEATE
DURAMED PHARMS BARR
IVAX SUB TEVA PHARMS
SANDOZ
PROCYCLIDINE HYDROCHLORIDE
TABLET;ORAL
KEMADRIN
MONARCH PHARMS
PROGESTERONE
CAPSULE;ORAL
PROMETRIUM
ABBVIE INC
INJECTABLE;INJECTION
PROGESTERONE
LILLY
INSERT, EXTENDED RELEASE;INTRAUTERINE
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
2MG
5MG
300MG
25MG/ML
50MG/ML
PROGESTASERT
ALZA
PROMAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
SPARINE
WYETH AYERST
INJECTABLE;INJECTION
PROMAZINE HYDROCHLORIDE
WATSON LABS
SPARINE
BAXTER HLTHCARE CORP
SYRUP;ORAL
SPARINE
WYETH AYERST
TABLET;ORAL
SPARINE
WYETH AYERST
PROMETHAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
PHENERGAN
WYETH AYERST
PROMETHAZINE HYDROCHLORIDE
ABBOTT
AKORN
BEDFORD LABS
HOSPIRA
38MG
30MG/ML
100MG/ML
25MG/ML
50MG/ML
25MG/ML
50MG/ML
10MG/5ML
10MG
25MG
50MG
100MG
200MG
25MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG/ML
50MG/ML
50MG/ML
6-264( of 322)
N010571 001
N010571 002
N010571 003
A085580 001
A085178 001
A085579 001
A040207 001 May 01, 1997
A089484 001 Jan 20, 1987
A040207 002 May 01, 1997
A089485 001 Jan 20, 1987
A089486 001 Jan 20, 1987
A040162 001 Jan 20, 1998
A040162 002 Jan 20, 1998
A040101 003 Jul 19, 1996
N009818 005
N009818 003
N019781 003 Oct 15, 1999
N009238 002
N009238 001
N017553 001
N010942 001
N010942 004
A084510 001
A084517 001
N010349 008
N010349 006
N010942 003
N010348 006
N010348 001
N010348 002
N010348 003
N010348 004
N008857 002
N008857 003
A084223 001
A084222 001
A083955 002
A083955 001
A040524 001 Mar 17, 2004
A040524 002 Mar 17, 2004
A040372 002 Jun 08, 2000
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-265( of 322)
PROMETHAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
PROMETHAZINE HYDROCHLORIDE
50MG/ML A083838 002
MARSAM PHARMS LLC 25MG/ML A089463 001 May 02, 1988
50MG/ML A089477 001 May 02, 1988
MYLAN INSTITUTIONAL 25MG/ML A040471 001 Nov 21, 2002
SANDOZ 25MG/ML A040593 001 Nov 08, 2006
50MG/ML A040593 002 Nov 08, 2006
WATSON LABS 25MG/ML A083532 001
25MG/ML A084591 001
50MG/ML A080629 002
50MG/ML A083532 002
ZIPAN-25
ALTANA 25MG/ML A083997 001
ZIPAN-50
ALTANA 50MG/ML A083997 002
SUPPOSITORY;RECTAL
PHENERGAN
SHIONOGI INC 12.5MG N010926 002
25MG N010926 001
50MG N011689 001
PROMETHACON
POLYMEDICA 25MG A084901 001
50MG A084902 001
PROMETHAZINE HYDROCHLORIDE
ABLE 12.5MG A040504 001 Apr 11, 2003
25MG A040504 002 Apr 11, 2003
50MG A040449 001 Feb 27, 2003
SYRUP;ORAL
MYMETHAZINE FORTIS
USL PHARMA 25MG/5ML A087996 001 Jan 18, 1983
PROMETH FORTIS
ALPHARMA US PHARMS 25MG/5ML A084772 001
PROMETH PLAIN
ACTAVIS MID ATLANTIC 6.25MG/5ML A085953 001
PROMETHAZINE
CENCI 6.25MG/5ML A089013 001 Sep 20, 1985
PROMETHAZINE HYDROCHLORIDE
KV PHARM 6.25MG/5ML A085388 001
25MG/5ML A085385 001
PHARM ASSOC 6.25MG/5ML A087518 001
WHITEWORTH TOWN PLSN 6.25MG/5ML A086395 001
PROMETHAZINE HYDROCHLORIDE PLAIN
ANI PHARMS 6.25MG/5ML N008381 004 Apr 18, 1984
25MG/5ML **Federal Register N008381 003
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
PHENERGAN
WYETH PHARMS INC 12.5MG N007935 002
25MG N007935 003
50MG N007935 004
PROMETHAZINE HYDROCHLORIDE
ABBOTT 12.5MG A084160 001
25MG A084166 001
50MG A084539 001
ABLE 12.5MG A040558 001 Jul 01, 2004
25MG A040558 002 Jul 01, 2004
50MG A040558 003 Jul 01, 2004
IMPAX LABS 25MG A084214 002 Jul 07, 1982
IVAX SUB TEVA PHARMS 12.5MG A083604 001
25MG A083603 001
50MG A083613 001
LANNETT 12.5MG A080949 001
25MG A080949 002
50MG A080949 003
MUTUAL PHARM 12.5MG A084555 001
25MG A084554 001
50MG A084557 001
PVT FORM 12.5MG A083214 001
25MG A083658 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-266( of 322)
PROMETHAZINE HYDROCHLORIDE
TABLET;ORAL
PROMETHAZINE HYDROCHLORIDE
SANDOZ 12.5MG A084176 002 May 22, 2009
12.5MG A084233 001
25MG A085146 001
50MG A085146 002
TABLICAPS 12.5MG A084080 001
25MG A084027 001
TEVA 25MG A089109 001 Sep 10, 1985
WATSON LABS 12.5MG A083401 001
12.5MG A083712 001
12.5MG A085986 001
25MG A083204 001
25MG A085684 001
50MG A083403 001
50MG A085664 001
REMSED
BRISTOL MYERS SQUIBB 25MG A083176 002
50MG A083176 001
PROPAFENONE HYDROCHLORIDE
TABLET;ORAL
PROPAFENONE HYDROCHLORIDE
NESHER PHARMS 150MG A076193 001 Feb 07, 2002
225MG A076193 002 Feb 07, 2002
300MG A076193 003 Feb 07, 2002
PROPANTHELINE BROMIDE
INJECTABLE;INJECTION
PRO-BANTHINE
GD SEARLE LLC 30MG/VIAL N008843 001
TABLET;ORAL
PRO-BANTHINE
SHIRE 7.5MG **Federal Register determination N008732 003
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
15MG N008732 002
PROPANTHELINE BROMIDE
ASCOT 15MG A087663 001 Oct 25, 1982
HEATHER 15MG A085780 001
IMPAX LABS 15MG A084541 002
MYLAN 15MG A083706 001
PAR PHARM 15MG A088377 001 Dec 08, 1983
PVT FORM 15MG A080977 001
ROXANE 7.5MG A080927 001
SANDOZ 15MG A080928 001
TABLICAPS 15MG A084428 001
WATSON LABS 15MG A083029 002
15MG A083151 001
PROPARACAINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
KAINAIR
PHARMAFAIR 0.5% A088087 001 Jun 07, 1983
PARACAINE
OPTOPICS 0.5% A087681 001 Aug 05, 1982
PROPARACAINE HYDROCHLORIDE
SOLA BARNES HIND 0.5% A084144 001
0.5% A084151 001
PROPIOLACTONE
SOLUTION;IRRIGATION
BETAPRONE
FOREST LABS N/A N011657 001
PROPIOMAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
LARGON
HIKMA MAPLE 20MG/ML N012382 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PROPOFOL
INJECTABLE;INJECTION
DIPRIVAN
FRESENIUS KABI USA
PROPOFOL
BEDFORD
TEVA PARENTERAL
PROPOXYPHENE HYDROCHLORIDE
CAPSULE;ORAL
DARVON
XANODYNE PHARM
DOLENE
HERITAGE PHARMS INC
KESSO-GESIC
MK LABS
PROPHENE 65
HALSEY
PROPOXYPHENE HYDROCHLORIDE
ALRA
IMPAX LABS
IVAX SUB TEVA PHARMS
MUTUAL PHARM
MYLAN
NEXGEN PHARMA INC
PAR PHARM
PUREPAC PHARM
PVT FORM
ROXANE
SANDOZ
TEVA
VALEANT PHARM INTL
VINTAGE PHARMS
WATSON LABS
WEST WARD
WHITEWORTH TOWN PLSN
10MG/ML
10MG/ML
10MG/ML
32MG
65MG
65MG
65MG
65MG
65MG
65MG
32MG
65MG
32MG
65MG
65MG
65MG
65MG
65MG
32MG
65MG
32MG
65MG
32MG
65MG
65MG
65MG
65MG
65MG
65MG
65MG
65MG
65MG
65MG
65MG
PROPOXYPHENE HYDROCHLORIDE 65
WARNER CHILCOTT 65MG
PROPOXYPHENE NAPSYLATE
SUSPENSION;ORAL
DARVON-N
AAIPHARMA LLC 50MG/5ML
TABLET;ORAL
DARVON-N
XANODYNE PHARM 100MG
PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
PROPRANOLOL HYDROCHLORIDE
INWOOD LABS 60MG
80MG
120MG
160MG
CONCENTRATE;ORAL
PROPRANOLOL HYDROCHLORIDE INTENSOL
ROXANE
INJECTABLE;INJECTION
PROPRANOLOL HYDROCHLORIDE
SMITH AND NEPHEW
SOLOPAK
80MG/ML
1MG/ML
1MG/ML
1MG/ML
6-267( of 322)
N019627 001 Oct 02, 1989
A074848 001 Apr 19, 2005
A075392 001 Sep 19, 2000
N010997 001
N010997 003
A080530 001
A083544 001
A083538 002
A083184 001
A083317 001
A083597 001
A083186 001
A083528 001
A040569 001 Dec 16, 2004
A083299 001
A083185 001
A080269 001
A083278 001
A083464 001
A083113 001
A083089 001
A083089 002
A084014 001
A083125 002
A083688 001
A083870 002
A086495 001
A088615 001 Oct 22, 1984
A080783 001
A040908 001 Jul 17, 2009
A080908 002
A085190 001
A083501 001
A084551 001
A083786 001
N016861 001
N016862 002
A072499 001 Apr 11, 1989
A072500 001 Apr 11, 1989
A072501 001 Apr 11, 1989
A072502 001 Apr 11, 1989
A071388 001 May 15, 1987
A070135 001 Apr 15, 1986
A070137 001 Apr 15, 1986
A070136 001 Apr 15, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-268( of 322)
PROPRANOLOL HYDROCHLORIDE
SOLUTION;ORAL
PROPRANOLOL HYDROCHLORIDE
MORTON GROVE 20MG/5ML A071984 001 Mar 03, 1989
40MG/5ML A071985 001 Mar 03, 1989
SUSPENSION;ORAL
INDERAL
WYETH AYERST 10MG/ML N019536 001 Dec 12, 1986
TABLET;ORAL
INDERAL
WYETH PHARMS INC 10MG N016418 001
20MG N016418 003
90MG **Federal Register determination N016418 010 Oct 18, 1982
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PROPRANOLOL HYDROCHLORIDE
CLONMEL HLTHCARE 10MG A070125 001 Jul 30, 1985
20MG A070126 001 Jul 30, 1985
40MG A070127 001 Jul 30, 1985
60MG A071495 001 Dec 31, 1987
80MG A070128 001 Jul 30, 1985
90MG A071496 001 Dec 31, 1987
DURAMED PHARMS BARR 10MG A070306 001 Sep 09, 1985
20MG A070307 001 Sep 09, 1985
40MG A070308 001 Sep 09, 1985
60MG A070309 001 Oct 01, 1986
80MG A070310 001 Sep 09, 1985
90MG A071327 001 Oct 01, 1986
INTERPHARM 10MG A071368 001 May 05, 1987
20MG A071369 001 May 05, 1987
40MG A071370 001 May 05, 1987
80MG A071371 001 May 05, 1987
IVAX SUB TEVA PHARMS 10MG A072063 001 Jul 29, 1988
20MG A072066 001 Jul 29, 1988
40MG A072067 001 Jul 29, 1988
60MG A072068 001 Jul 29, 1988
80MG A072069 001 Jul 29, 1988
LEDERLE 10MG A072117 001 Jun 23, 1988
20MG A072118 001 Jun 23, 1988
40MG A072119 001 Jun 23, 1988
80MG A072120 001 Jun 23, 1988
MUTUAL PHARM 10MG A070319 001 Oct 22, 1985
20MG A070320 001 Oct 22, 1985
40MG A070103 001 Oct 22, 1985
60MG A070321 001 Sep 24, 1986
80MG A070322 001 Aug 04, 1986
MYLAN 60MG A072275 001 Jun 09, 1989
PAR PHARM 90MG A071288 001 Oct 22, 1986
PLIVA 90MG A071977 001 Apr 06, 1988
PUREPAC PHARM 10MG A070814 001 Nov 03, 1986
20MG A070815 001 Nov 03, 1986
40MG A070816 001 Nov 03, 1986
60MG A070817 001 Nov 03, 1986
80MG A070757 001 Nov 03, 1986
ROXANE 10MG A070516 001 Jul 07, 1986
20MG A070517 001 Jul 07, 1986
40MG A070518 001 Jul 07, 1986
60MG A070519 001 Sep 24, 1986
80MG A070520 001 Jul 07, 1986
90MG A070521 001 Sep 24, 1986
SANDOZ 10MG A070663 001 Jun 13, 1986
10MG A071658 001 Jul 05, 1988
20MG A070664 001 Jun 13, 1986
20MG A071687 001 Jul 05, 1988
40MG A070665 001 Jun 13, 1986
40MG A071688 001 Jul 05, 1988
60MG A070666 001 Oct 10, 1986
60MG A072197 001 Jul 05, 1988
80MG A070667 001 Jun 13, 1986
80MG A071689 001 Jul 05, 1988
90MG A072198 001 Jul 05, 1988
SCHERING 10MG A070120 001 Aug 06, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-269( of 322)
PROPRANOLOL HYDROCHLORIDE
TABLET;ORAL
PROPRANOLOL HYDROCHLORIDE
20MG A070121 001 Aug 06, 1985
40MG A070122 001 Aug 06, 1985
60MG A070123 001 Oct 29, 1986
80MG A070124 001 Aug 06, 1985
SUPERPHARM 10MG A071515 001 Jun 08, 1988
20MG A071516 001 Jun 08, 1988
40MG A071517 001 Jun 08, 1988
80MG A071518 001 Jun 08, 1988
TEVA 10MG A070232 001 Oct 07, 1987
20MG A070233 001 Jun 23, 1986
40MG A070234 001 Jun 23, 1986
WARNER CHILCOTT 10MG A070438 001 Sep 15, 1986
20MG A070439 001 Sep 15, 1986
40MG A070440 001 Sep 15, 1986
60MG A070441 001 Sep 24, 1986
80MG A070442 001 Sep 15, 1986
WATSON LABS 10MG A070140 001 Jul 30, 1985
10MG A070378 001 Mar 19, 1987
10MG A070548 001 Jul 10, 1986
20MG A070141 001 Jul 30, 1985
20MG A070379 001 Mar 19, 1987
20MG A070549 001 Apr 11, 1986
40MG A070142 001 Jul 30, 1985
40MG A070380 001 Mar 19, 1987
40MG A070550 001 Apr 11, 1986
60MG A070143 001 Jan 15, 1987
60MG A070381 001 Mar 19, 1987
60MG A071098 001 Oct 06, 1986
60MG A071791 001 Jul 15, 1987
80MG A070144 001 Jul 30, 1985
80MG A070382 001 Mar 19, 1987
80MG A070551 001 Jul 10, 1986
90MG A071183 001 Oct 06, 1986
90MG A071792 001 Jul 15, 1987
PROPYLIODONE
SUSPENSION;INTRATRACHEAL
DIONOSIL AQUEOUS
GLAXOSMITHKLINE 50% N009309 001
DIONOSIL OILY
GLAXOSMITHKLINE 60% N009309 002
PROPYLTHIOURACIL
TABLET;ORAL
PROPYLTHIOURACIL
ABBOTT 50MG A084075 001
ANABOLIC 50MG A080285 001
HALSEY 50MG A080015 001
IMPAX LABS 50MG A080159 001
IVAX SUB TEVA PHARMS 50MG A080215 001
LANNETT 50MG A080016 001
LILLY 50MG N006213 001
MUTUAL PHARM 50MG A083982 001
PERRIGO 50MG A084543 001
TABLICAPS 50MG A080840 001
WATSON LABS 50MG A080932 001
50MG A085201 001
WEST WARD 50MG A080154 001
PROTAMINE SULFATE
INJECTABLE;INJECTION
PROTAMINE SULFATE
HIKMA MAPLE 10MG/ML A089474 001 Nov 05, 1986
10MG/ML A089475 001 Nov 05, 1986
LILLY 10MG/ML N006460 002
PHARMACIA AND UPJOHN 50MG/VIAL N007413 001
250MG/VIAL N007413 002 Aug 02, 1984
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-270( of 322)
PROTEIN HYDROLYSATE
INJECTABLE;INJECTION
AMINOSOL 5%
ABBVIE 5% N005932 012 Jan 31, 1985
HYPROTIGEN 5%
B BRAUN 5% N006170 003 Jan 10, 1984
PROTIRELIN
INJECTABLE;INJECTION
THYPINONE
ABBOTT 0.5MG/ML N017638 001
THYREL TRH
FERRING 0.5MG/ML N018087 001
PROTOKYLOL HYDROCHLORIDE
TABLET;ORAL
VENTAIRE
SANOFI AVENTIS US 2MG A083459 001
PROTRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
VIVACTIL
TEVA WOMENS 5MG N016012 001
10MG N016012 002
PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
NOVAFED
SANOFI AVENTIS US 120MG N017603 001
SUDAFED 12 HOUR
GLAXOSMITHKLINE 120MG **Federal Register determination N017941 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
ACTIFED
GLAXOSMITHKLINE 120MG;5MG N018996 001 Jun 17, 1985
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES
KV PHARM 120MG;5MG A071798 001 Mar 16, 1989
SYRUP;ORAL
ACTAHIST
CENCI 30MG/5ML;1.25MG/5ML A088344 001 Feb 09, 1984
HISTAFED
CENCI 30MG/5ML;1.25MG/5ML A088283 001 Apr 20, 1984
MYFED
USL PHARMA 30MG/5ML;1.25MG/5ML A088116 001 Mar 04, 1983
TRILITRON
NEWTRON PHARMS 30MG/5ML;1.25MG/5ML A088474 001 Feb 12, 1985
TABLET;ORAL
ALLERFED
PVT FORM 60MG;2.5MG A088860 001 Jan 31, 1985
CORPHED
SANDOZ 60MG;2.5MG A088602 001 Apr 11, 1985
PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE
SANDOZ 60MG;2.5MG A088193 001 May 17, 1983
TRILITRON
NEWTRON PHARMS 60MG;2.5MG A088515 001 Jan 09, 1985
TRIPHED
TEVA 60MG;2.5MG A088630 001 May 17, 1984
TRIPROLIDINE AND PSEUDOEPHEDRINE
WATSON LABS 60MG;2.5MG A088318 002 Jan 13, 1984
WEST WARD 60MG;2.5MG A088117 001 Apr 19, 1983
TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 60MG;2.5MG A085273 001 Dec 12, 1984
SUPERPHARM 60MG;2.5MG A088578 001 Feb 21, 1985
TABLET, EXTENDED RELEASE;ORAL
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES
KV PHARM 120MG;5MG A072758 001 Nov 25, 1991
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
PSEUDOEPHEDRINE POLISTIREX
SUSPENSION, EXTENDED RELEASE;ORAL
PSEUDO-12
UCB INC
PYRIDOSTIGMINE BROMIDE
TABLET;ORAL
PYRIDOSTIGMINE BROMIDE
BARR
COREPHARMA
SOLVAY
US ARMY
PYRIDOXINE HYDROCHLORIDE
INJECTABLE;INJECTION
HEXA-BETALIN
LILLY
PYRIDOXINE HYDROCHLORIDE
AKORN
BEL MAR
DELL LABS
ELKINS SINN
LUITPOLD
WATSON LABS
PYRILAMINE MALEATE
TABLET;ORAL
PYRILAMINE MALEATE
IMPAX LABS
WATSON LABS
PYRIMETHAMINE; SULFADOXINE
TABLET;ORAL
FANSIDAR
ROCHE
PYRITHIONE ZINC
LOTION;TOPICAL
HEAD & SHOULDERS CONDITIONER
WARNER CHILCOTT
PYRVINIUM PAMOATE
SUSPENSION;ORAL
POVAN
PARKE DAVIS
TABLET;ORAL
POVAN
PARKE DAVIS
QUAZEPAM
TABLET;ORAL
DORAL
SCIECURE PHARMA INC
QUETIAPINE FUMARATE
TABLET;ORAL
SEROQUEL
ASTRAZENECA
QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
QUINAPRIL HYDROCHLORIDE
ACTAVIS TOTOWA
APOTEX INC
MYLAN
EQ 60MG HCL/5ML
30MG
60MG
60MG
30MG
30MG
100MG/ML
100MG/ML
100MG/ML
50MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
25MG
25MG
25MG;500MG
0.3%
EQ 50MG BASE/5ML
EQ 50MG BASE
7.5MG
EQ 150MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
6-271( of 322)
N019401 001 Jun 19, 1987
A040512 002 Jul 20, 2005
A040512 001 Oct 08, 2003
A040457 001 Dec 26, 2002
A089572 001 Nov 27, 1990
N020414 001 Feb 05, 2003
A080854 001
A087967 001 Oct 01, 1982
A080761 001
A083771 001
A083772 001
A080581 001
A080669 001
A080572 001
A083760 001
A080808 001
A085231 001
N018557 001
N019412 002 Mar 10, 1986
N011964 001
N012485 002
N018708 003 Feb 26, 1987
N020639 004 Dec 20, 1998
A076459 001 Dec 22, 2004
A076459 002 Dec 22, 2004
A076459 003 Dec 22, 2004
A076459 004 Dec 22, 2004
A076240 001 Jan 26, 2006
A076240 002 Jan 26, 2006
A076240 003 Jan 26, 2006
A076240 004 Jan 26, 2006
A076036 001 Jan 28, 2005
A076036 002 Jan 28, 2005
A076036 003 Jan 28, 2005
A076036 004 Jan 28, 2005
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-272( of 322)
QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
QUINAPRIL HYDROCHLORIDE
SANDOZ
QUINESTROL
TABLET;ORAL
ESTROVIS
PARKE DAVIS
QUINETHAZONE
TABLET;ORAL
HYDROMOX
LEDERLE
QUINETHAZONE; RESERPINE
TABLET;ORAL
HYDROMOX R
LEDERLE
QUINIDINE GLUCONATE
TABLET;ORAL
QUINACT
BAYER HLTHCARE
TABLET, EXTENDED RELEASE;ORAL
DURAQUIN
WARNER CHILCOTT
QUINAGLUTE
BAYER HLTHCARE
QUINALAN
LANNETT
QUINATIME
WATSON LABS
QUINIDINE GLUCONATE
ASCOT
HALSEY
ROXANE
SANDOZ
SUPERPHARM
WATSON LABS
QUINIDINE POLYGALACTURONATE
TABLET;ORAL
CARDIOQUIN
PHARM RES ASSOC
QUINIDINE SULFATE
CAPSULE;ORAL
CIN-QUIN
SOLVAY
QUINIDINE SULFATE
LILLY
TABLET;ORAL
CIN-QUIN
SOLVAY
QUINIDINE SULFATE
BARR
CLONMEL HLTHCARE
CONTRACT PHARMACAL
ELKINS SINN
EVERYLIFE
HALSEY
IMPAX LABS
IVAX SUB TEVA PHARMS
KING PHARMS
KV PHARM
LANNETT
EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
0.1MG
0.2MG
50MG
50MG;0.125MG
266MG
400MG
330MG
324MG
324MG
324MG
324MG
324MG
324MG
324MG
324MG
324MG
275MG
200MG
300MG
200MG
100MG
200MG
300MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
A076803 001 Mar 02, 2005
A076803 002 Mar 02, 2005
A076803 003 Mar 02, 2005
A076803 004 Mar 02, 2005
N016768 002
N016768 003
N013264 001
N013927 001
A085978 001
A086099 001
N017917 001
N016647 001
A088081 001 Feb 10, 1986
A087448 001
A088582 001 Jun 17, 1985
A089476 001 Apr 10, 1987
A088431 001 Jan 06, 1984
A089894 001 Dec 15, 1988
A089164 001 Nov 21, 1985
A087785 001 Jan 24, 1983
N011642 002
A085296 001
A085297 001
A085103 001
A085299 001
A084932 001
A085298 001
A084177 001
A087011 001
A083808 001
A083622 001
A083439 001
A083583 001
A083347 001
A084549 001
A085175 001
A085276 001
A083743 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
QUINIDINE SULFATE
TABLET;ORAL
QUINIDINE SULFATE
LEDERLE
LILLY
MUTUAL PHARM
PERRIGO
PHARMAVITE
PUREPAC PHARM
ROXANE
SANDOZ
SCHERER LABS
SUPERPHARM
USL PHARMA
VALEANT PHARM INTL
VANGARD
VINTAGE PHARMS
WARNER CHILCOTT
WATSON LABS
WEST WARD
WHITEWORTH TOWN PLSN
QUINORA
KEY PHARMS
SCHERING
TABLET, EXTENDED RELEASE;ORAL
QUINIDEX
WYETH PHARMS INC
RABEPRAZOLE SODIUM
TABLET, DELAYED RELEASE;ORAL
ACIPHEX
EISAI INC
RAMIPRIL
CAPSULE;ORAL
RAMIPRIL
ACTAVIS ELIZABETH
CIPLA
RANBAXY LABS LTD
TABLET;ORAL
ALTACE
KING PFIZER
200MG A086176 001
200MG A085038 001
100MG A081029 001
200MG A085322 001
200MG A084627 001
200MG A084003 001
200MG A083640 001
300MG A085632 001
200MG A084631 001
200MG A084914 001
300MG A089839 001
200MG A085068 001
200MG A088973 001
200MG A087837 001
200MG A083393 001
200MG A087909 001
200MG A083963 001
200MG A083879 001
100MG A085584 001
200MG A085140 002
200MG A083862 001
200MG A085444 001
200MG A083576 001
300MG A085222 001
300MG N012796 002
10MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N020973 001
1.25MG A077513 001
2.5MG A077513 002
5MG A077513 003
10MG A077513 004
1.25MG A077004 001
2.5MG A077004 002
5MG A077004 003
10MG A077004 004
5MG A078849 001
10MG A078849 002
1.25MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N022021 001
2.5MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N022021 002
5MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N022021 003
10MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N022021 004
6-273( of 322)
Apr 14, 1989
Sep 29, 1988
Apr 10, 1985
Apr 14, 1982
Jul 13, 1982
May 29, 2002
Jun 18, 2008
Jun 18, 2008
Jun 18, 2008
Jun 18, 2008
Aug 07, 2008
Aug 07, 2008
Aug 07, 2008
Aug 07, 2008
Mar 06, 2009
Mar 06, 2009
Feb 27, 2007
Feb 27, 2007
Feb 27, 2007
Feb 27, 2007
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-274( of 322)
RANITIDINE BISMUTH CITRATE
TABLET;ORAL
TRITEC
GLAXOSMITHKLINE 400MG N020559 001 Aug 08, 1996
RANITIDINE HYDROCHLORIDE
CAPSULE;ORAL
RANITIDINE HYDROCHLORIDE
MYLAN EQ 150MG BASE A075564 001 Oct 27, 2000
EQ 300MG BASE A075564 002 Oct 27, 2000
TEVA EQ 150MG BASE A075557 001 Oct 31, 2003
EQ 300MG BASE A075557 002 Oct 31, 2003
ZANTAC 150
GLAXOSMITHKLINE EQ 150MG BASE N020095 001 Mar 08, 1994
ZANTAC 300
GLAXOSMITHKLINE EQ 300MG BASE N020095 002 Mar 08, 1994
GRANULE, EFFERVESCENT;ORAL
ZANTAC 150
GLAXO GRP LTD EQ 150MG BASE/PACKET N020251 002 Mar 31, 1994
INJECTABLE;INJECTION
RANITIDINE HYDROCHLORIDE
BEDFORD EQ 25MG BASE/ML A074764 001 Nov 19, 2004
ZANTAC IN PLASTIC CONTAINER
COVIS PHARMA SARL EQ 1MG BASE/ML N019593 002 Sep 27, 1991
EQ 50MG BASE/100ML N019593 001 Dec 17, 1986
SYRUP;ORAL
RANITIDINE HYDROCHLORIDE
APOTEX INC EQ 15MG BASE/ML A077602 001 Sep 17, 2007
RANBAXY EQ 15MG BASE/ML A078448 001 Dec 13, 2007
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
BOEHRINGER INGELHEIM EQ 150MG BASE A074662 001 Aug 29, 1997
EQ 300MG BASE A074662 002 Aug 29, 1997
MYLAN EQ 150MG BASE A074552 001 Jul 30, 1998
EQ 300MG BASE A074552 002 Jul 30, 1998
RANBAXY EQ 75MG BASE A075132 001 Jan 14, 2000
EQ 75MG BASE A075254 001 Jan 14, 2000
EQ 150MG BASE A075000 001 Jan 30, 1998
EQ 150MG BASE A075439 001 Apr 19, 2000
EQ 300MG BASE A075000 002 Jan 30, 1998
EQ 300MG BASE A075439 002 Apr 19, 2000
SANDOZ EQ 75MG BASE A075519 001 Sep 26, 2002
WATSON LABS EQ 75MG BASE A075212 001 Jan 14, 2000
EQ 150MG BASE A074864 001 Oct 20, 1997
EQ 300MG BASE A074864 002 Oct 20, 1997
WATSON LABS INC EQ 150MG BASE A077426 001 Dec 19, 2005
EQ 300MG BASE A077426 002 Dec 19, 2005
TABLET, EFFERVESCENT;ORAL
ZANTAC 150
GLAXO GRP LTD EQ 150MG BASE N020251 001 Mar 31, 1994
ZANTAC 75
BOEHRINGER INGELHEIM EQ 75MG BASE **Federal Register N020745 001 Feb 26, 1998
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
RAPACURONIUM BROMIDE
INJECTABLE;INJECTION
RAPLON
ORGANON USA INC 100MG/VIAL N020984 001 Aug 18, 1999
200MG/VIAL N020984 002 Aug 18, 1999
RAUWOLFIA SERPENTINA ROOT
TABLET;ORAL
HIWOLFIA
BOWMAN PHARMS 50MG N009276 003
50MG N009276 005
100MG N009276 004
HYSERPIN
PHYS PRODS VA 50MG N010581 001
KOGLUCOID
PANRAY 50MG N009278 001
100MG N009278 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-275( of 322)
RAUWOLFIA SERPENTINA ROOT
TABLET;ORAL
RAUDIXIN
APOTHECON 50MG N008842 001
100MG N008842 002
RAUSERPIN
FERNDALE LABS 50MG N009926 002
100MG N009926 004
RAUVAL
PAL PAK 50MG N009108 002
100MG N009108 004
RAUWOLFIA SERPENTINA
BUNDY 50MG N009477 001
100MG N009477 002
HALSEY 50MG A080498 001
100MG A080498 002
IMPAX LABS 50MG N009273 001
100MG N009273 002
IVAX SUB TEVA PHARMS 50MG N011521 001
100MG N011521 002
PUREPAC PHARM 50MG A080842 001
100MG A080842 002
PVT FORM 50MG A080583 001
100MG A080583 002
SOLVAY 50MG A080500 001
100MG A080500 002
TABLICAPS 50MG A083867 001
100MG A083444 001
VALEANT PHARM INTL 50MG N009668 001
100MG N009668 002
WATSON LABS 50MG A080907 001
100MG A080914 001
WOLFINA
FOREST PHARMS 50MG N009255 008
100MG N009255 006
RESCINNAMINE
CAPSULE;ORAL
CINNASIL
PANRAY 0.5MG A084736 001
TABLET;ORAL
MODERIL
PFIZER 0.25MG N010686 003
0.5MG N010686 006
RESERPINE
ELIXIR;ORAL
SERPASIL
NOVARTIS
INJECTABLE;INJECTION
0.2MG/4ML N009115 005
SANDRIL
LILLY
SERPASIL
2.5MG/ML N010012 001
NOVARTIS
TABLET;ORAL
2.5MG/ML N009434 002
HISERPIA
BOWMAN PHARMS 0.1MG N009631 002
0.25MG N009631 004
RAU-SED
BRISTOL MYERS SQUIBB 0.1MG N009357 001
0.25MG N009357 004
0.5MG N009357 006
1MG N009357 008
RESERPINE
BARR 0.25MG A080721 002
BELL PHARMA 0.1MG A083058 001
0.25MG A083058 002
BUNDY 0.1MG N009663 001
0.25MG N009663 003
ELKINS SINN 0.1MG A083145 001
0.25MG A083145 002
EVERYLIFE 0.1MG N010441 001
0.25MG N010441 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
RESERPINE
TABLET;ORAL
RESERPINE
0.5MG
1MG
HALSEY 0.1MG
0.25MG
1MG
IMPAX LABS 0.1MG
0.25MG
IVAX SUB TEVA PHARMS 0.1MG
0.25MG
MARSHALL PHARMA 0.1MG
0.25MG
MK LABS 0.1MG
0.25MG
MYLAN 1MG
PHARMAVITE 0.25MG
PUREPAC PHARM 0.1MG
0.25MG
PVT FORM 0.1MG
0.25MG
0.25MG
1MG
REXALL 0.25MG
ROXANE 0.1MG
0.25MG
SOLVAY 0.25MG
TABLICAPS 0.25MG
TEVA 0.1MG
0.25MG
VALEANT PHARM INTL 0.1MG
0.25MG
WATSON LABS 0.1MG
0.25MG
0.25MG
1MG
WEST WARD 0.1MG
0.25MG
1MG
WHITEWORTH TOWN PLSN 0.1MG
0.25MG
1MG
SANDRIL
LILLY 0.1MG
0.25MG
SERPALAN
LANNETT 0.1MG
0.25MG
SERPANRAY
PANRAY 0.1MG
0.25MG
1MG
SERPASIL
NOVARTIS 0.1MG
0.25MG
1MG
SERPATE
VALE 0.1MG
0.25MG
SERPIVITE
VITARINE 0.25MG
RESERPINE; TRICHLORMETHIAZIDE
TABLET;ORAL
METATENSIN #2
SANOFI AVENTIS US 0.1MG;2MG
METATENSIN #4
SANOFI AVENTIS US 0.1MG;4MG
NAQUIVAL
SCHERING 0.1MG;4MG
6-276( of 322)
N010441 003
N010441 004
A080457 002
A080457 001
A080457 003
N009627 001
N009627 002
N011185 001
N011185 002
A080492 001
A080492 002
A080525 002
A080525 001
A084974 001
A084663 001
A080753 002
A080753 001
A086117 001
A080582 001
A085775 001
A080582 002
A080637 001
N009859 001
N009859 002
A080446 001
A085207 001
A089020 001 Mar 07, 1985
A089019 001 Mar 07, 1985
N009667 001
N009667 002
A080679 001
A080393 001
A085401 001
A080749 001
A080975 001
A080975 002
A080975 003
A080723 001
A080723 002
A080723 003
N009376 004
N009376 001
N010124 001
N010124 002
N009391 001
N009391 002
N009391 004
N009115 001
N009115 003
N009115 004
N009453 001
N009453 002
N009645 002
N012972 001
N012972 002
N012265 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-277( of 322)
RESERPINE; TRICHLORMETHIAZIDE
TABLET;ORAL
TRICHLORMETHIAZIDE W/ RESERPINE
WATSON LABS 0.1MG;4MG A085248 001
RIBAVIRIN
TABLET;ORAL
COPEGUS
ROCHE 400MG N021511 002 Jun 21, 2005
RIMANTADINE HYDROCHLORIDE
SYRUP;ORAL
FLUMADINE
FOREST LABS
TABLET;ORAL
RIMANTADINE HYDROCHLORIDE
50MG/5ML N019650 001 Sep 17, 1993
ACTAVIS TOTOWA
COREPHARMA
100MG
100MG
A076375 001
A075916 001
Jan 14, 2003
Nov 02, 2001
RISEDRONATE SODIUM
TABLET;ORAL
ACTONEL
WARNER CHILCOTT LLC 75MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
N020835 004 Apr 16, 2007
RISPERIDONE
TABLET;ORAL
RISPERDAL
JANSSEN PHARMS
RISPERIDONE
5MG N020272 005 Dec 29, 1993
CADISTA PHARMS
RATIOPHARM
SYNTHON PHARMS
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
A078828 001
A078828 002
A078828 003
A078828 004
A078828 005
A078828 006
A077784 001
A077784 002
A077784 003
A077784 004
A077784 005
A077784 006
A078187 001
A078187 002
A078187 003
A078187 004
A078187 005
A078187 006
Mar 23, 2009
Mar 23, 2009
Mar 23, 2009
Mar 23, 2009
Mar 23, 2009
Mar 23, 2009
Jun 08, 2010
Jun 08, 2010
Jun 08, 2010
Jun 08, 2010
Jun 08, 2010
Jun 08, 2010
Oct 22, 2009
Oct 22, 2009
Oct 22, 2009
Oct 22, 2009
Oct 22, 2009
Oct 22, 2009
RITODRINE HYDROCHLORIDE
INJECTABLE;INJECTION
RITODRINE HYDROCHLORIDE
ABRAXIS PHARM 10MG/ML
15MG/ML
HOSPIRA 10MG/ML
15MG/ML
RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
A071188 001
A071189 001
A071618 001
A071619 001
Jul 23, 1987
Jul 23, 1987
Feb 28, 1991
Feb 28, 1991
HOSPIRA
YUTOPAR
30MG/100ML A071438 001 Jan 22, 1991
ASTRAZENECA
TABLET;ORAL
YUTOPAR
10MG/ML
15MG/ML
N018580 001
N018580 002
ASTRAZENECA 10MG N018555 001
RITONAVIR
CAPSULE;ORAL
NORVIR
ABBOTT 100MG N020680 001 Mar 01, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-278( of 322)
ROCURONIUM BROMIDE
INJECTABLE;INJECTION
ZEMURON
ORGANON USA INC 10MG/ML (10MG/ML) N020214 002 Mar 17, 1994
ROFECOXIB
SUSPENSION;ORAL
VIOXX
MERCK 12.5MG/5ML N021052 001 May 20, 1999
25MG/5ML N021052 002 May 20, 1999
TABLET;ORAL
VIOXX
MERCK 12.5MG N021042 001 May 20, 1999
25MG N021042 002 May 20, 1999
50MG N021042 003 Feb 25, 2000
ROPINIROLE HYDROCHLORIDE
TABLET;ORAL
ROPINIROLE HYDROCHLORIDE
COREPHARMA EQ 0.25MG BASE A078230 001 May 20, 2008
EQ 0.5MG BASE A078230 002 May 20, 2008
EQ 1MG BASE A078230 003 May 20, 2008
EQ 2MG BASE A078230 004 May 20, 2008
EQ 3MG BASE A078230 005 May 20, 2008
EQ 4MG BASE A078230 006 May 20, 2008
EQ 5MG BASE A078230 007 May 20, 2008
TABLET, EXTENDED RELEASE;ORAL
REQUIP XL
GLAXOSMITHKLINE LLC EQ 3MG BASE N022008 002 Jun 13, 2008
ROSE BENGAL SODIUM I-131
INJECTABLE;INJECTION
ROBENGATOPE
BRACCO 0.5mCi/VIAL N016224 001
1mCi/VIAL N016224 002
2mCi/VIAL N016224 003
SODIUM ROSE BENGAL I 131
SORIN 0.5mCi/ML N017318 001
RUFINAMIDE
TABLET;ORAL
BANZEL
EISAI INC 100MG **Federal Register determination N021911 001 Nov 14, 2008
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SAFFLOWER OIL
INJECTABLE;INJECTION
LIPOSYN 10%
ABBOTT 10% (10GM/100ML) N018203 001
LIPOSYN 20%
ABBOTT 20% (20GM/100ML) N018614 001
SALMETEROL XINAFOATE
AEROSOL, METERED;INHALATION
SEREVENT
GLAXOSMITHKLINE EQ 0.021MG BASE/INH N020236 001 Feb 04, 1994
SAQUINAVIR
CAPSULE;ORAL
FORTOVASE
HOFFMANN LA ROCHE 200MG N020828 001 Nov 07, 1997
SARALASIN ACETATE
INJECTABLE;INJECTION
SARENIN
PROCTER AND GAMBLE EQ 0.6MG BASE/ML N018009 001
SECOBARBITAL SODIUM
CAPSULE;ORAL
SECOBARBITAL SODIUM
ANABOLIC 100MG A084422 001
BARR 100MG A084225 001
EVERYLIFE 100MG A085895 001
HALSEY 100MG A084676 001
IVAX PHARMS 100MG A085869 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-279( of 322)
A085285 001
A085909 001
A085903 001
A084762 001
A084561 001
A085867 001
A085477 001
A085898 001
A086273 001
A085792 001
A084926 001
A085798 001
A086390 001
A083281 001
A083262 001
N007392 002
A086530 001
A086530 002
A086530 003
A086530 004
N018290 001
N021136 001 Apr 04, 2002
A075145 001 Sep 15, 2003
A074641 001 Aug 02, 1996
A074756 001 Nov 25, 1998
A074672 001 Apr 01, 1997
N019334 001 Jun 05, 1989
A074537 001 Aug 02, 1996
A074744 001 Jan 27, 1997
A074565 001 Aug 02, 1996
A083892 001
A084394 001
A085777 001
A086209 001
N017257 001
N017098 001
N017322 001
N017047 001
SECOBARBITAL SODIUM
CAPSULE;ORAL
SECOBARBITAL SODIUM
KV PHARM
LANNETT
PARKE DAVIS
PERRIGO
PUREPAC PHARM
VALEANT PHARM INTL
VITARINE
WATSON LABS
WEST WARD
WHITEWORTH TOWN PLSN
WYETH AYERST
INJECTABLE;INJECTION
SECOBARBITAL SODIUM
ELKINS SINN
WYETH AYERST
SECONAL SODIUM
LILLY
SUPPOSITORY;RECTAL
SECONAL SODIUM
LILLY
SECRETIN
INJECTABLE;INJECTION
SECRETIN-FERRING
FERRING
SECRETIN SYNTHETIC PORCINE
FOR SOLUTION;INTRAVENOUS
SECREFLO
CHIRHOCLIN
SELEGILINE HYDROCHLORIDE
CAPSULE;ORAL
SELEGILINE HYDROCHLORIDE
AAIPHARMA LLC
TABLET;ORAL
SELEGILINE HYDROCHLORIDE
DAVA PHARMS INC
IVAX SUB TEVA PHARMS
SIEGFRIED
SOMERSET
TEVA
VINTAGE PHARMS LLC
SELENIUM SULFIDE
LOTION/SHAMPOO;TOPICAL
EXSEL
ALLERGAN HERBERT
SELENIUM SULFIDE
ACTAVIS MID ATLANTIC
IVAX PHARMS
TARO
SELENOMETHIONINE SE-75
INJECTABLE;INJECTION
SELENOMETHIONINE SE 75
GE HEALTHCARE
MALLINCKRODT
PHARMALUCENCE
SETHOTOPE
BRACCO
100MG
50MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG/VIAL
50MG/ML
50MG/ML
30MG
60MG
120MG
200MG
75CU/VIAL
16MCG/VIAL
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
2.5%
2.5%
2.5%
2.5%
250uCi/ML
100uCi/ML
500uCi/ML
85-550uCi/ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-280( of 322)
SERACTIDE ACETATE
INJECTABLE;INJECTION
ACTHAR GEL-SYNTHETIC
ARMOUR PHARM 40 UNITS/ML N017861 001
80 UNITS/ML N017861 002
SERMORELIN ACETATE
INJECTABLE;INJECTION
GEREF
EMD SERONO EQ 0.05MG BASE/AMP N019863 001 Dec 28, 1990
EMD SERONO INC EQ 0.5MG BASE/VIAL **Federal Register N020443 001 Sep 26, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 1MG BASE/VIAL **Federal Register N020443 002 Sep 26, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
SERTRALINE HYDROCHLORIDE
CONCENTRATE;ORAL
SERTRALINE HYDROCHLORIDE
RANBAXY LABS LTD EQ 20MG BASE/ML A078053 001 Feb 05, 2007
ROXANE EQ 20MG BASE/ML A076934 001 Jun 30, 2006
TABLET;ORAL
SERTRALINE HYDROCHLORIDE
ACTAVIS ELIZABETH EQ 25MG BASE A077345 001 Feb 06, 2007
EQ 50MG BASE A077345 002 Feb 06, 2007
EQ 100MG BASE A077345 003 Feb 06, 2007
CIPLA LTD EQ 25MG BASE A077162 001 Feb 06, 2007
EQ 50MG BASE A077162 002 Feb 06, 2007
EQ 100MG BASE A077162 003 Feb 06, 2007
DR REDDYS LABS LTD EQ 25MG BASE A076442 001 Apr 30, 2007
EQ 50MG BASE A076442 002 Apr 30, 2007
EQ 100MG BASE A076442 003 Apr 30, 2007
IVAX SUB TEVA PHARMS EQ 25MG BASE A075719 003 Jun 30, 2006
EQ 50MG BASE A075719 001 Jun 30, 2006
EQ 100MG BASE A075719 002 Jun 30, 2006
MUTUAL PHARM EQ 25MG BASE A077818 001 Feb 06, 2007
EQ 50MG BASE A077818 002 Feb 06, 2007
EQ 100MG BASE A077818 003 Feb 06, 2007
MYLAN PHARMS INC EQ 25MG BASE A076540 001 Mar 20, 2007
EQ 50MG BASE A076540 002 Mar 20, 2007
EQ 100MG BASE A076540 003 Mar 20, 2007
PLIVA HRVATSKA DOO EQ 25MG BASE A077299 001 Feb 06, 2007
EQ 50MG BASE A077299 002 Feb 06, 2007
EQ 100MG BASE A077299 003 Feb 06, 2007
ROXANE EQ 25MG BASE A076881 001 Feb 06, 2007
EQ 50MG BASE A076881 002 Feb 06, 2007
EQ 100MG BASE A076881 003 Feb 06, 2007
SANDOZ EQ 25MG BASE A077713 001 Feb 06, 2007
EQ 50MG BASE A077713 002 Feb 06, 2007
EQ 100MG BASE A077713 003 Feb 06, 2007
ZOLOFT
PFIZER EQ 150MG BASE N019839 003 Dec 30, 1991
EQ 200MG BASE N019839 004 Dec 30, 1991
SEVELAMER HYDROCHLORIDE
CAPSULE;ORAL
RENAGEL
GENZYME 403MG N020926 001 Oct 30, 1998
SIBUTRAMINE HYDROCHLORIDE
CAPSULE;ORAL
MERIDIA
ABBOTT 5MG N020632 001 Nov 22, 1997
10MG N020632 002 Nov 22, 1997
15MG N020632 003 Nov 22, 1997
SILVER SULFADIAZINE
DRESSING;TOPICAL
SILDAFLO
FRANKLIN PHARMS 1% N019608 001 Nov 30, 1989
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-281( of 322)
SIMETHICONE-CELLULOSE
SUSPENSION;ORAL
SONORX
BRACCO 7.5MG/ML N020773 001 Oct 29, 1998
SIMVASTATIN
TABLET;ORAL
SIMVASTATIN
SANDOZ INC 5MG A077766 001 Dec 20, 2006
10MG A077766 002 Dec 20, 2006
20MG A077766 003 Dec 20, 2006
40MG A077766 004 Dec 20, 2006
80MG A077766 005 Dec 20, 2006
TABLET, ORALLY DISINTEGRATING;ORAL
SIMVASTATIN
SYNTHON PHARMS 10MG N021961 001 Oct 09, 2007
20MG N021961 002 Oct 09, 2007
40MG N021961 003 Oct 09, 2007
80MG N021961 004 Oct 09, 2007
SIMVASTATIN; SITAGLIPTIN PHOSPHATE
TABLET;ORAL
JUVISYNC
MERCK SHARP DOHME 10MG;EQ 50MG BASE N202343 004 Sep 18, 2012
10MG;EQ 100MG BASE N202343 001 Oct 07, 2011
20MG;EQ 50MG BASE N202343 005 Sep 18, 2012
20MG;EQ 100MG BASE N202343 002 Oct 07, 2011
40MG;EQ 50MG BASE N202343 006 Sep 18, 2012
40MG;EQ 100MG BASE N202343 003 Oct 07, 2011
SIROLIMUS
TABLET;ORAL
RAPAMUNE
PF PRISM CV 5MG **Federal Register determination N021110 003 Feb 23, 2004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SODIUM BENZOATE; SODIUM PHENYLACETATE
SOLUTION;ORAL
UCEPHAN
B BRAUN 100MG/ML;100MG/ML N019530 001 Dec 23, 1987
SODIUM BICARBONATE
INJECTABLE;INJECTION
SODIUM BICARBONATE IN PLASTIC CONTAINER
ABBOTT 0.9MEQ/ML N019443 001 Jun 03, 1986
1MEQ/ML N019443 002 Jun 03, 1986
SODIUM BICARBONATE; TARTARIC ACID
GRANULE, EFFERVESCENT;ORAL
BAROS
MALLINCKRODT INC 460MG/GM;420MG/GM N018509 001 Aug 07, 1985
SODIUM CHLORIDE
INJECTABLE;INJECTION
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABRAXIS PHARM 9MG/ML A088909 001 Feb 07, 1985
SODIUM CHLORIDE
ABBOTT 20GM/100ML N017013 001
B BRAUN 20GM/100ML N017038 001
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 450MG/100ML N018184 001
MILES 450MG/100ML N018503 001
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABBOTT 9MG/ML N019218 001 Jul 13, 1984
MILES 900MG/100ML N018502 001
SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER
ABRAXIS PHARM 234MG/ML N019329 001 Apr 22, 1987
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
B BRAUN 3GM/100ML N019635 003 Mar 09, 1988
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML N019635 004 Mar 09, 1988
SOLUTION;IRRIGATION
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE 450MG/100ML N017864 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-282( of 322)
SODIUM CHLORIDE
SOLUTION;IRRIGATION
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
450MG/100ML
HOSPIRA 450MG/100ML
450MG/100ML
SODIUM CHLORIDE IN PLASTIC CONTAINER
N018497 001
N017670 001
N018380 001
Feb 19, 1982
MILES 900MG/100ML N018247 001
SODIUM CHROMATE CR-51
INJECTABLE;INJECTION
CHROMITOPE SODIUM
BRACCO
SODIUM CHROMATE CR 51
2mCi/VIAL
200uCi/ML
N013993 002
N013993 001
MALLINCKRODT 100uCi/ML N016708 001
SODIUM FLUORIDE F-18
INJECTABLE;INTRAVENOUS
FLUORINE F-18
GE HEALTHCARE
SODIUM FLUORIDE F 18
2mCi/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
N017042 001
NIH NCI DCTD 10-200mCi/ML N022494 001 Jan 26, 2011
SODIUM IODIDE I-123
CAPSULE;ORAL
SODIUM IODIDE I 123
CARDINAL HLTH 414
GE HEALTHCARE
400uCi
100uCi
N018671 003
N017630 001
May 27, 1982
SOLUTION;ORAL
SODIUM IODIDE I 123
GE HEALTHCARE 2mCi/ML N017630 002
SODIUM IODIDE I-131
CAPSULE;ORAL
IODOTOPE
BRACCO 1-130mCi N010929 001
1-150mCi N010929 003
SODIUM IODIDE I 131
CIS 50uCi N017316 001
100uCi N017316 002
MALLINCKRODT 0.8-100mCi N016515 002
15-100uCi N016517 002
SODIUM IODIDE I-131
JUBILANT DRAXIMAGE
SOLUTION;ORAL
HICON
2-200mCi N021305 004 Nov 18, 2004
JUBILANT DRAXIMAGE
IODOTOPE
1-250mCi/0.25ML
1-500mCi/0.5ML
1-1000mCi/ML
N021305 002
N021305 003
N021305 005
Jan 24, 2003
Jan 24, 2003
Apr 04, 2006
BRACCO
SODIUM IODIDE I 131
7-106mCi/BOT N010929 002
CIS 50mCi/ML N017315 001
SODIUM LACTATE
INJECTABLE;INJECTION
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
B BRAUN
HOSPIRA
1.87GM/100ML
1.87GM/100ML
N018186 001
N018249 001
SODIUM MONOFLUOROPHOSPHATE
GEL;DENTAL
EXTRA-STRENGTH AIM
CHESEBROUGH PONDS
PASTE;DENTAL
EXTRA-STRENGTH AIM
1.2% N019518 002 Aug 06, 1986
CHESEBROUGH PONDS 1.2% N019518 001 Jun 03, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-283( of 322)
SODIUM NITROPRUSSIDE
INJECTABLE;INJECTION
NIPRIDE
ROCHE 50MG/VIAL N017546 001
NITROPRESS
ABBOTT 50MG/VIAL A071555 001 Nov 16, 1987
ABBVIE 50MG/VIAL N018450 001
HOSPIRA 50MG/VIAL A070566 001 Jun 09, 1986
SODIUM NITROPRUSSIDE
ABRAXIS PHARM 50MG/VIAL A070031 001 Jan 17, 1985
BAXTER HLTHCARE 50MG/VIAL N018581 001 Jul 28, 1982
TEVA PARENTERAL 25MG/ML A073465 001 Mar 30, 1992
SODIUM PHOSPHATE P-32
SOLUTION;INJECTION, ORAL
PHOSPHOTOPE
BRACCO 1-8mCi/VIAL N010927 001
SODIUM PHOSPHATE P 32
MALLINCKRODT 0.67mCi/ML N011777 001
1.5mCi/VIAL N011777 002
SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
TABLET;ORAL
VISICOL
SALIX PHARMS 0.398GM;1.102GM N021097 001 Sep 21, 2000
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
TABLET;ORAL
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
NOVEL LABS INC 0.398GM;1.102GM A079247 001 Dec 30, 2011
SODIUM POLYSTYRENE SULFONATE
POWDER;ORAL, RECTAL
SODIUM POLYSTYRENE SULFONATE
CITRUSPHRMA 454GM/BOT A040909 001 Dec 03, 2008
WOCKHARDT 453.6GM/BOT A088786 001 Sep 11, 1984
SUSPENSION;ORAL, RECTAL
SODIUM POLYSTYRENE SULFONATE
MORTON GROVE 15GM/60ML A088717 001 Sep 11, 1984
ROXANE 15GM/60ML A088453 001 Nov 17, 1983
SODIUM SUCCINATE
INJECTABLE;INJECTION
SODIUM SUCCINATE
ELKINS SINN 30% A080516 001
SODIUM TETRADECYL SULFATE
INJECTABLE;INJECTION
SOTRADECOL
ELKINS SINN 1% **Federal Register determination N005970 004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
3% **Federal Register determination N005970 005
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SODIUM THIOSULFATE
INJECTABLE;INJECTION
SODIUM THIOSULFATE
US ARMY 250MG/ML N020166 001 Feb 14, 1992
SOMATREM
INJECTABLE;INJECTION
PROTROPIN
GENENTECH 5MG/VIAL N019107 001 Oct 17, 1985
10MG/VIAL N019107 002 Oct 24, 1989
SOMATROPIN
INJECTABLE;INJECTION
ASELLACRIN 10
SERONO 10 IU/VIAL N017726 001
ASELLACRIN 2
SERONO 2 IU/VIAL N017726 002 Jul 21, 1983
CRESCORMON
GENENTECH 4 IU/VIAL N017992 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-284( of 322)
SOMATROPIN RECOMBINANT
INJECTABLE;INJECTION
ACCRETROPIN
CANGENE 5MG/ML (5MG/ML) N021538 001 Jan 23, 2008
BIO-TROPIN
FERRING 4.8MG/VIAL N019774 001 May 25, 1995
HUMATROPE
LILLY 2MG/VIAL N019640 001 Jun 23, 1987
NORDITROPIN
NOVO NORDISK INC 4MG/VIAL N019721 001 May 08, 1995
5MG/1.5ML N021148 001 Jun 20, 2000
8MG/VIAL N019721 002 May 08, 1995
10MG/1.5ML N021148 002 Jun 20, 2000
15MG/1.5ML N021148 003 Jun 20, 2000
NORDITROPIN NORDIFLEX
NOVO NORDISK INC 5MG/1.5ML N021148 004 Oct 01, 2004
10MG/1.5ML N021148 005 Oct 01, 2004
15MG/1.5ML N021148 006 Oct 01, 2004
NUTROPIN DEPOT
GENENTECH 13.5MG/VIAL N021075 001 Dec 22, 1999
18MG/VIAL N021075 002 Dec 22, 1999
22.5MG/VIAL N021075 003 Dec 22, 1999
SAIZEN
EMD SERONO 4MG/VIAL N019764 005 Jan 16, 2007
6MG/VIAL N019764 001 Oct 08, 1996
SEROSTIM
EMD SERONO 8.8MG/VIAL N020604 004 Sep 06, 2001
ZORBTIVE
EMD SERONO 4MG/VIAL N021597 001 Dec 01, 2003
5MG/VIAL N021597 002 Dec 01, 2003
6MG/VIAL N021597 003 Dec 01, 2003
INJECTABLE;SUBCUTANEOUS
SEROSTIM LQ
EMD SERONO 6MG/0.5ML (6MG/0.5ML) N020604 005 Feb 11, 2005
SORBITOL
SOLUTION;IRRIGATION
SORBITOL 3% IN PLASTIC CONTAINER
BAXTER HLTHCARE 3GM/100ML N018512 001 May 27, 1982
SOTALOL HYDROCHLORIDE
TABLET;ORAL
BETAPACE
BAYER HLTHCARE 320MG N019865 004 Oct 30, 1992
BETAPACE AF
BAYER HLTHCARE 40MG N021151 006 Apr 02, 2003
60MG N021151 007 Apr 02, 2003
100MG N021151 005 Mar 14, 2003
SOTALOL HYDROCHLORIDE
MUTUAL PHARM 80MG A075515 001 Oct 15, 2001
80MG A076576 001 Apr 08, 2004
120MG A075515 004 Oct 15, 2001
120MG A076576 002 Apr 08, 2004
160MG A075515 002 Oct 15, 2001
160MG A076576 003 Apr 08, 2004
240MG A075515 003 Oct 15, 2001
WATSON LABS 80MG A075238 001 Jul 13, 2000
120MG A075238 002 Jul 13, 2000
160MG A075238 003 Jul 13, 2000
240MG A075238 004 Jul 13, 2000
SOYBEAN OIL
INJECTABLE;INJECTION
SOYACAL 10%
ALPHA THERA 10% N018465 001 Jun 29, 1983
SOYACAL 20%
ALPHA THERA 20% N018786 001 Jun 29, 1983
TRAVAMULSION 10%
BAXTER HLTHCARE 10% N018660 001 Feb 26, 1982
TRAVAMULSION 20%
BAXTER HLTHCARE 20% N018758 001 Feb 15, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
SPARFLOXACIN
TABLET;ORAL
ZAGAM
MYLAN
SPECTINOMYCIN HYDROCHLORIDE
INJECTABLE;INJECTION
TROBICIN
PFIZER
SPIRAPRIL HYDROCHLORIDE
TABLET;ORAL
RENORMAX
SCHERING
SPIRONOLACTONE
TABLET;ORAL
SPIRONOLACTONE
ASCOT
IVAX PHARMS
LEDERLE
MUTUAL PHARM
MYLAN
PUREPAC PHARM
SUPERPHARM
UPSHER SMITH
VANGARD
WARNER CHILCOTT
WATSON LABS
STANOZOLOL
TABLET;ORAL
WINSTROL
LUNDBECK INC
STAVUDINE
CAPSULE;ORAL
ZERIT
BRISTOL MYERS SQUIBB
200MG
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
3MG
6MG
12MG
24MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
2MG
5MG
CAPSULE, EXTENDED RELEASE;ORAL
ZERIT XR
BRISTOL MYERS SQUIBB 37.5MG
50MG
75MG
100MG
STERILE WATER FOR INJECTION
LIQUID;N/A
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
ABRAXIS PHARM 100%
100%
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
B BRAUN 100%
STERILE WATER FOR IRRIGATION
LIQUID;IRRIGATION
STERILE WATER IN PLASTIC CONTAINER
MILES
STREPTOMYCIN SULFATE
INJECTABLE;INJECTION
STREPTOMYCIN SULFATE
COPANOS
LILLY
PFIZER
100%
EQ 500MG BASE/ML
EQ 1GM BASE/VIAL
EQ 1GM BASE/2ML
EQ 5GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/2.5ML
EQ 5GM BASE/VIAL
6-285( of 322)
N020677 001 Dec 19, 1996
N050347 001
N050347 002
N020240 001 Dec 29, 1994
N020240 002 Dec 29, 1994
N020240 003 Dec 29, 1994
N020240 004 Dec 29, 1994
A087687 001 Oct 20, 1982
A087108 001
A087634 001
A087265 001
A087086 001
A087998 001 Oct 14, 1983
A088053 001 Aug 25, 1983
A089364 001 Nov 07, 1986
A087554 001
A087648 001 Feb 01, 1982
A087952 001 Nov 18, 1982
A086898 002 Mar 02, 1982
A087078 001
N012885 001 May 14, 1984
N020412 001 Jun 24, 1994
N021453 001 Dec 31, 2002
N021453 002 Dec 31, 2002
N021453 003 Dec 31, 2002
N021453 004 Dec 31, 2002
A089099 001 Dec 29, 1987
A089100 001 Dec 29, 1987
N019077 001 Mar 02, 1984
N018246 001
A060684 001
A060107 001
A060404 001
A060107 002
A060076 001
A060111 001
A060076 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
SUCCINYLCHOLINE CHLORIDE
INJECTABLE;INJECTION
ANECTINE
SANDOZ
QUELICIN PRESERVATIVE FREE
HOSPIRA
SUCCINYLCHOLINE CHLORIDE
INTL MEDICATION
ORGANON USA INC
SUCOSTRIN
APOTHECON
SUFENTANIL CITRATE
INJECTABLE;INJECTION
SUFENTANIL CITRATE
WATSON LABS
SULFACETAMIDE SODIUM
OINTMENT;OPHTHALMIC
BLEPH-10
ALLERGAN
SODIUM SULAMYD
SCHERING
SULFAIR 10
PHARMAFAIR
SOLUTION/DROPS;OPHTHALMIC
BLEPH-30
ALLERGAN
ISOPTO CETAMIDE
ALCON
OCUSULF-10
MIZA PHARMS USA
OCUSULF-30
MIZA PHARMS USA
SODIUM SULAMYD
SCHERING
SODIUM SULFACETAMIDE
AKORN
SOLA BARNES HIND
SULF-10
NOVARTIS
SULF-15
NOVARTIS
SULFACEL-15
OPTOPICS
SULFACETAMIDE SODIUM
AKORN
ALCON PHARMS LTD
PHARMAFAIR
SULFAIR 10
PHARMAFAIR
SULFAIR FORTE
PHARMAFAIR
SULFAIR-15
PHARMAFAIR
SULTEN-10
BAUSCH AND LOMB
1GM/VIAL
50MG/ML
500MG/VIAL
50MG/ML
100MG/VIAL
20MG/ML
20MG/ML
100MG/ML
EQ 0.05MG BASE/ML
10%
10%
10%
30%
15%
10%
30%
10%
30%
10%
15%
30%
10%
10%
30%
30%
10%
15%
15%
10%
30%
30%
10%
10%
30%
15%
10%
6-286( of 322)
N008453 004
N008453 003
N008453 001
N008845 002
A085400 001 Feb 04, 1982
A080997 001
N008847 001
N008847 003
A074406 001 Dec 15, 1995
A084015 001
N005963 002
A088000 001 Dec 22, 1982
A080028 002
A080020 002
A080660 001
A080660 002
N005963 001
N005963 003
A083021 001
A083021 002
A083021 003
A084143 001
A084145 001
A084146 001
A084147 001
A080025 001
A089047 001 Oct 31, 1995
A080024 001
A040215 001 May 25, 1999
A040216 001 May 25, 1999
A089068 001 May 05, 1987
A088947 001 May 17, 1985
A087949 001 Dec 13, 1982
A088385 001 Oct 13, 1983
A088186 001 May 25, 1983
A087818 001 Feb 03, 1983
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
SULFACYTINE
TABLET;ORAL
RENOQUID
GLENWOOD 250MG
SULFADIAZINE
TABLET;ORAL
SULFADIAZINE
ABBVIE 300MG
EVERYLIFE 500MG
IMPAX LABS 500MG
LANNETT 500MG
LEDERLE 500MG
LILLY 500MG
SULFADIAZINE SODIUM
INJECTABLE;INJECTION
SULFADIAZINE SODIUM
LEDERLE 250MG/ML
SULFADIAZINE; SULFAMERAZINE
SUSPENSION;ORAL
SULFONAMIDES DUPLEX
LILLY 250MG/5ML;250MG/5ML
SULFAMETER
TABLET;ORAL
SULLA
BAYER HLTHCARE 500MG
SULFAMETHIZOLE
TABLET;ORAL
MICROSUL
FOREST PHARMS 1GM
PROKLAR
FOREST PHARMS 500MG
THIOSULFIL
WYETH AYERST 250MG
500MG
SULFAMETHOXAZOLE
SUSPENSION;ORAL
GANTANOL
ROCHE 500MG/5ML
TABLET;ORAL
GANTANOL
ROCHE 500MG
GANTANOL-DS
ROCHE 1GM
SULFAMETHOXAZOLE
ASCOT 500MG
BARR 500MG
HEATHER 500MG
SANDOZ 500MG
WATSON LABS 1GM
500MG
UROBAK
SHIONOGI 500MG
SULFAMETHOXAZOLE; TRIMETHOPRIM
INJECTABLE;INJECTION
BACTRIM
MUTUAL PHARM 80MG/ML;16MG/ML
SEPTRA
MONARCH PHARMS 80MG/ML;16MG/ML
SULFAMETHOXAZOLE AND TRIMETHOPRIM
ABRAXIS PHARM 80MG/ML;16MG/ML
BEDFORD 80MG/ML;16MG/ML
HIKMA MAPLE 80MG/ML;16MG/ML
80MG/ML;16MG/ML
HOSPIRA 80MG/ML;16MG/ML
WATSON LABS 80MG/ML;16MG/ML
SUSPENSION;ORAL
BACTRIM
MUTUAL PHARM 200MG/5ML;40MG/5ML
6-287( of 322)
N017569 001
N004125 005
A080088 001
A080081 001
A080084 001
N004054 001
N004122 002
N004054 002
N006317 007
N016000 002
A086012 001
A080273 001
N008565 001
N008565 004
N013664 002
N012715 002
N012715 003
A087662 001 Oct 20, 1982
A087189 001 Jul 25, 1983
A086163 001
A085844 001
A086000 001
A085053 001
A087307 001
N018374 001
N018452 001
A070223 001 Dec 29, 1987
A072383 001 Apr 29, 1992
A070627 001 Dec 29, 1987
A070628 001 Dec 29, 1987
A073199 001 Sep 11, 1992
A071556 001 Dec 29, 1987
N017560 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-288( of 322)
SULFAMETHOXAZOLE; TRIMETHOPRIM
SUSPENSION;ORAL
BACTRIM PEDIATRIC
MUTUAL PHARM 200MG/5ML;40MG/5ML N017560 002
SEPTRA
MONARCH PHARMS 200MG/5ML;40MG/5ML N017598 001
SEPTRA GRAPE
MONARCH PHARMS 200MG/5ML;40MG/5ML N017598 002 Feb 12, 1986
SULFAMETHOXAZOLE AND TRIMETHOPRIM
TEVA 200MG/5ML;40MG/5ML A070028 001 Jun 02, 1987
200MG/5ML;40MG/5ML N018812 001 Jan 28, 1983
200MG/5ML;40MG/5ML N018812 002 Jun 10, 1983
TEVA PHARMS 200MG/5ML;40MG/5ML A077612 001 Nov 13, 2006
SULFATRIM
STI PHARMA LLC 200MG/5ML;40MG/5ML N018615 002 Jan 07, 1983
SULMEPRIM
USL PHARMA 200MG/5ML;40MG/5ML A070063 001 Aug 01, 1986
SULMEPRIM PEDIATRIC
USL PHARMA 200MG/5ML;40MG/5ML A070064 001 Aug 01, 1986
TRIMETH/SULFA
ALPHARMA US PHARMS 200MG/5ML;40MG/5ML A072289 001 May 23, 1988
200MG/5ML;40MG/5ML A072398 001 May 23, 1988
NASKA 200MG/5ML;40MG/5ML A072399 001 May 23, 1988
TABLET;ORAL
COTRIM
TEVA 400MG;80MG A070034 001 May 16, 1985
COTRIM D.S.
TEVA 800MG;160MG A070048 001 Mar 18, 1985
SULFAMETHOPRIM
NOVEL LABS INC 400MG;80MG A070022 001 Feb 15, 1985
SULFAMETHOPRIM-DS
NOVEL LABS INC 800MG;160MG A070032 001 Feb 15, 1985
SULFAMETHOXAZOLE AND TRIMETHOPRIM
HEATHER 400MG;80MG N018946 001 Aug 10, 1984
800MG;160MG N018946 002 Aug 10, 1984
INTERPHARM 400MG;80MG A071299 001 Oct 27, 1987
800MG;160MG A071300 001 Oct 27, 1987
MARTEC USA LLC 400MG;80MG A072408 001 Dec 07, 1988
MUTUAL PHARM 400MG;80MG A070006 001 Nov 14, 1984
400MG;80MG A071016 001 Aug 25, 1986
PLIVA 400MG;80MG A070215 001 Sep 10, 1985
800MG;160MG A070216 001 Sep 10, 1985
ROXANE 400MG;80MG A072768 001 Aug 30, 1991
SANDOZ 400MG;80MG A070889 001 Nov 13, 1986
400MG;80MG N018598 003 May 19, 1982
800MG;160MG A070890 001 Nov 13, 1986
TEVA 400MG;80MG N018242 001
800MG;160MG N018242 002
USL PHARMA 400MG;80MG A070203 001 Nov 08, 1985
800MG;160MG A070204 001 Nov 08, 1985
WATSON LABS 400MG;80MG A070002 001 Nov 07, 1984
400MG;80MG N018852 001 May 09, 1983
800MG;160MG A070000 001 Nov 07, 1984
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
MARTEC USA LLC 800MG;160MG A072417 001 Dec 07, 1988
MUTUAL PHARM 800MG;160MG A070007 001 Nov 14, 1984
ROXANE 800MG;160MG A072769 001 Aug 30, 1991
SANDOZ 800MG;160MG N018598 004 May 19, 1982
WATSON LABS 800MG;160MG N018854 001 May 09, 1983
SULFATRIM-DS
SUPERPHARM 800MG;160MG A070066 001 Jun 24, 1985
SULFATRIM-SS
SUPERPHARM 400MG;80MG A070065 002 Jun 24, 1985
UROPLUS DS
SHIONOGI 800MG;160MG A071816 001 Sep 28, 1987
UROPLUS SS
SHIONOGI 400MG;80MG A071815 001 Sep 28, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-289( of 322)
SULFANILAMIDE
CREAM;VAGINAL
SULFANILAMIDE
TEVA 15% A088718 001 Sep 19, 1985
SUPPOSITORY;VAGINAL
AVC
MEDA PHARMS 1.05GM N006530 004 Jan 27, 1987
SULFAPHENAZOLE
SUSPENSION;ORAL
SULFABID
PHARM RES ASSOC 500MG/5ML N013093 001
TABLET;ORAL
SULFABID
PURDUE FREDERICK 500MG N013092 002
SULFAPYRIDINE
TABLET;ORAL
SULFAPYRIDINE
LILLY 500MG N000159 001
SULFASALAZINE
SUSPENSION;ORAL
AZULFIDINE
PHARMACIA AND UPJOHN 250MG/5ML N018605 001
TABLET;ORAL
S.A.S.-500
SOLVAY 500MG A083450 001
SULFASALAZINE
HERITAGE PHARMS INC 500MG A080197 001
MUTUAL PHARM 500MG A089590 001 Oct 19, 1987
SANDOZ 500MG A086184 001
SUPERPHARM 500MG A089339 001 Oct 26, 1987
WATSON LABS 500MG A084964 001
TABLET, DELAYED RELEASE;ORAL
SULFASALAZINE
WATSON LABS 500MG A088052 001 May 24, 1983
SULFINPYRAZONE
CAPSULE;ORAL
ANTURANE
NOVARTIS 200MG **Federal Register determination N011556 004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SULFINPYRAZONE
BARR 200MG A087666 001 Sep 17, 1982
IVAX PHARMS 200MG A087770 001 Nov 19, 1982
PAR PHARM 200MG A088934 001 Sep 06, 1985
VANGARD 200MG A088666 001 Feb 17, 1984
TABLET;ORAL
ANTURANE
NOVARTIS 100MG **Federal Register determination N011556 003
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SULFINPYRAZONE
BARR 100MG A087665 001 Sep 17, 1982
IVAX PHARMS 100MG A087769 001 Jun 01, 1982
PAR PHARM 100MG A088933 001 Sep 06, 1985
WATSON LABS 100MG A087667 001 May 26, 1982
SULFISOXAZOLE
TABLET;ORAL
GANTRISIN
ROCHE 500MG N006525 001
SOSOL
MK LABS 500MG A080036 001
SOXAZOLE
ALRA 500MG A080366 001
SULFALAR
PARKE DAVIS 500MG A084955 001
SULFISOXAZOLE
BARR 500MG A084031 001
HEATHER 500MG A080189 001
IMPAX LABS 500MG A080109 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
SULFISOXAZOLE
TABLET;ORAL
SULFISOXAZOLE
IVAX SUB TEVA PHARMS
LANNETT
LEDERLE
PHARMERAL
PUREPAC PHARM
ROXANE
SANDOZ
VALEANT PHARM INTL
VITARINE
WATSON LABS
WEST WARD
SULSOXIN
SOLVAY
SULFISOXAZOLE ACETYL
EMULSION;ORAL
LIPO GANTRISIN
ROCHE
SUSPENSION;ORAL
GANTRISIN PEDIATRIC
ROCHE
SYRUP;ORAL
GANTRISIN
ROCHE
SULFISOXAZOLE DIOLAMINE
INJECTABLE;INJECTION
GANTRISIN
ROCHE
OINTMENT;OPHTHALMIC
GANTRISIN
ROCHE
SOLUTION/DROPS;OPHTHALMIC
GANTRISIN
ROCHE
SULFISOXAZOLE DIOLAMINE
SOLA BARNES HIND
SULFOXONE SODIUM
TABLET, DELAYED RELEASE;ORAL
DIASONE SODIUM
ABBVIE
SULFUR
POWDER;TOPICAL
BENSULFOID
POYTHRESS
SULINDAC
TABLET;ORAL
CLINORIL
MERCK
SULINDAC
SANDOZ
TEVA
SUMATRIPTAN
SPRAY;NASAL
IMITREX
GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE
INJECTABLE;SUBCUTANEOUS
SUMATRIPTAN SUCCINATE
FRESENIUS KABI USA
SANDOZ
TEVA PARENTERAL
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
EQ 1GM BASE/5ML
EQ 500MG BASE/5ML
EQ 500MG BASE/5ML
EQ 400MG BASE/ML
EQ 4% BASE
EQ 4% BASE
EQ 4% BASE
165MG
33.32%
150MG
150MG
200MG
150MG
200MG
10MG/SPRAY
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
6-290( of 322)
A080142 001
A080085 001
A087649 001
A084385 001
A080087 001
A080082 001
A085628 001
A080268 002
A087332 001
A085534 001
A080379 001
A080040 001
N009182 009
N009182 004
N009182 002
N006917 001
N008414 002
N007757 002
A084148 001
N006044 003
N002918 001
N017911 001
A072712 001 Aug 30, 1991
A072713 001 Aug 30, 1991
A072972 001 Feb 28, 1992
A072973 001 Feb 28, 1992
N020626 002 Aug 26, 1997
A079240 002 Sep 18, 2009
A079240 001 Sep 18, 2009
A078067 002 Feb 06, 2009
A078067 001 Feb 06, 2009
A078318 001 Feb 06, 2009
A078318 002 Feb 06, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-291( of 322)
SUMATRIPTAN SUCCINATE
TABLET;ORAL
SUMATRIPTAN SUCCINATE
MYLAN EQ 25MG BASE A077163 001 Nov 02, 2009
EQ 50MG BASE A077163 002 Nov 02, 2009
EQ 100MG BASE A077163 003 Nov 02, 2009
ROXANE EQ 25MG BASE A078241 001 Aug 10, 2009
EQ 50MG BASE A078241 002 Aug 10, 2009
EQ 100MG BASE A078241 003 Aug 10, 2009
TEVA EQ 25MG BASE A076840 001 Feb 09, 2009
EQ 50MG BASE A076840 002 Feb 09, 2009
EQ 100MG BASE A076840 003 Feb 09, 2009
SUPROFEN
SOLUTION/DROPS;OPHTHALMIC
PROFENAL
ALCON 1% N019387 001 Dec 23, 1988
SUTILAINS
OINTMENT;TOPICAL
TRAVASE
ABBOTT 82,000 UNITS/GM **Federal Register N012828 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TACRINE HYDROCHLORIDE
CAPSULE;ORAL
COGNEX
SHIONOGI INC EQ 10MG BASE N020070 001 Sep 09, 1993
EQ 20MG BASE N020070 002 Sep 09, 1993
EQ 30MG BASE N020070 003 Sep 09, 1993
EQ 40MG BASE N020070 004 Sep 09, 1993
TALBUTAL
TABLET;ORAL
LOTUSATE
SANOFI AVENTIS US 120MG N009410 005
TAMOXIFEN CITRATE
TABLET;ORAL
NOLVADEX
ASTRAZENECA EQ 10MG BASE N017970 001
EQ 20MG BASE N017970 002 Mar 21, 1994
TAMOXIFEN CITRATE
AEGIS PHARMS EQ 10MG BASE A076398 001 Mar 31, 2003
EQ 20MG BASE A076398 002 Mar 31, 2003
IVAX SUB TEVA PHARMS EQ 10MG BASE A075740 001 Feb 20, 2003
EQ 20MG BASE A075740 002 Feb 20, 2003
PHARMACHEMIE EQ 10MG BASE A074539 001 Mar 31, 2003
ROXANE EQ 10MG BASE A076027 001 Feb 20, 2003
EQ 20MG BASE A076027 002 Feb 20, 2003
TEVA EQ 10MG BASE A074504 001 Apr 28, 2003
EQ 20MG BASE A074504 002 Apr 28, 2003
TECHNETIUM TC-99M ALBUMIN AGGREGATED
INJECTABLE;INJECTION
TC 99M-LUNGAGGREGATE
GE HEALTHCARE 5mCi/ML N017848 001
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
INJECTABLE;INJECTION
A-N STANNOUS AGGREGATED ALBUMIN
SYNCOR PHARMS N/A N017916 001
AN-MAA
PHARMALUCENCE N/A N017792 001
LUNGAGGREGATE REAGENT
GE HEALTHCARE N/A N017838 001
MACROTEC
BRACCO N/A N017833 001
TECHNESCAN MAA
MALLINCKRODT N/A N017842 001
TECHNETIUM TC 99M MAA
GE HEALTHCARE N/A N017773 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
TECHNETIUM TC-99M ALBUMIN COLLOID KIT
INJECTABLE;INJECTION
MICROLITE
PHARMALUCENCE N/A
TECHNETIUM TC-99M ALBUMIN KIT
INJECTABLE;INJECTION
TECHNETIUM TC 99M HSA
GE HEALTHCARE N/A
TECHNETIUM TC-99M ALBUMIN MICROSPHERES KIT
INJECTABLE;INJECTION
INSTANT MICROSPHERES
3M N/A
TECHNETIUM TC-99M APCITIDE
INJECTABLE;INJECTION
ACUTECT
CIS BIO INTL SA N/A
TECHNETIUM TC-99M DEPREOTIDE
INJECTABLE;INJECTION
NEO TECT KIT
CIS BIO INTL SA N/A
TECHNETIUM TC-99M ETIDRONATE KIT
INJECTABLE;INJECTION
CINTICHEM TECHNETIUM 99M HEDSPA
GE HEALTHCARE N/A
MPI STANNOUS DIPHOSPHONATE
GE HEALTHCARE N/A
OSTEOSCAN
MALLINCKRODT N/A
TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT
GE HEALTHCARE N/A
TECHNETIUM TC-99M FERPENTETATE KIT
INJECTABLE;INJECTION
RENOTEC
BRACCO N/A
TECHNETIUM TC-99M GLUCEPTATE KIT
INJECTABLE;INJECTION
GLUCOSCAN
BRISTOL MYERS SQUIBB N/A
TECHNESCAN GLUCEPTATE
DRAXIMAGE N/A
TECHNETIUM TC-99M LIDOFENIN KIT
INJECTABLE;INJECTION
TECHNESCAN HIDA
DRAXIMAGE N/A
TECHNETIUM TC-99M MEDRONATE
INJECTABLE;INJECTION
DRAXIMAGE MDP-10
JUBILANT DRAXIMAGE N/A
TECHNETIUM TC-99M MEDRONATE KIT
INJECTABLE;INJECTION
AMERSCAN MDP KIT
GE HEALTHCARE N/A
OSTEOLITE
PHARMALUCENCE N/A
TECHNETIUM TC 99M MPI MDP
GE HEALTHCARE N/A
N/A
TECHNETIUM TC-99M PENTETATE KIT
INJECTABLE;INJECTION
MPI DTPA KIT - CHELATE
GE HEALTHCARE N/A
TECHNETIUM TC-99M PENTETATE KIT
GE HEALTHCARE N/A
6-292( of 322)
N018263 001 Mar 25, 1983
N017775 001
N017832 001
N020887 001 Sep 14, 1998
N021012 001 Aug 03, 1999
N017653 001
N017667 001
N017454 001
N017562 001
N017045 001
N017907 001
N018272 001 Jan 27, 1982
N018489 001 Oct 31, 1986
N018035 001
N018335 001 Aug 05, 1982
N017972 001
N018141 001
N018141 002 Jun 12, 1989
N017255 001
N017264 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
TECHNETIUM TC-99M POLYPHOSPHATE KIT
INJECTABLE;INJECTION
SODIUM POLYPHOSPHATE-TIN KIT
GE HEALTHCARE N/A
TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT
INJECTABLE;INJECTION
PYROLITE
PHARMALUCENCE N/A
TECHNETIUM TC-99M PYROPHOSPHATE KIT
INJECTABLE;INJECTION
PHOSPHOTEC
BRACCO N/A
TECHNETIUM TC-99M RED BLOOD CELL KIT
INJECTABLE;INJECTION
RBC-SCAN
CADEMA N/A
TECHNETIUM TC-99M SESTAMIBI KIT
INJECTABLE;INJECTION
MIRALUMA
LANTHEUS MEDCL N/A
TECHNETIUM TC-99M SODIUM PERTECHNETATE
SOLUTION;INJECTION, ORAL
SODIUM PERTECHNETATE TC 99M
GE HEALTHCARE 2-100mCi/ML
MALLINCKRODT 10-60mCi/ML
PHARMALUCENCE 12mCi/ML
24mCi/ML
48mCi/ML
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
SOLUTION;INJECTION, ORAL
MINITEC
BRACCO 0.22-2.22 CI/GENERATOR
TECHNETIUM TC 99M GENERATOR
GE HEALTHCARE 830-16600mCi/GENERATOR
TECHNETIUM TC-99M SULFUR COLLOID
SOLUTION;INJECTION, ORAL
TECHNETIUM TC 99M SULFUR COLLOID
GE HEALTHCARE 4mCi/ML
SOLUTION;ORAL
TECHNETIUM TC 99M SULFUR COLLOID
MALLINCKRODT 3mCi/ML
TECHNETIUM TC-99M SULFUR COLLOID KIT
SOLUTION;INJECTION, ORAL
TECHNECOLL
MALLINCKRODT N/A
TECHNETIUM TC 99M TSC
GE HEALTHCARE N/A
TESULOID
BRACCO N/A
TECHNETIUM TC-99M TEBOROXIME KIT
INJECTABLE;INJECTION
CARDIOTEC
BRACCO N/A
TEGASEROD MALEATE
TABLET;ORAL
ZELNORM
NOVARTIS EQ 2MG BASE
EQ 6MG BASE
TELBIVUDINE
SOLUTION;ORAL
TYZEKA
NOVARTIS 100MG/5ML
6-293( of 322)
N017664 001
N017684 001
N017680 001
N020063 001 Jun 11, 1992
N019785 003 May 23, 1997
N017471 001
N017725 001
N017321 001
N017321 002
N017321 003
N017339 001
N017693 001
N017456 001
N017724 001
N017059 001
N017784 001
N016923 001
N019928 001 Dec 19, 1990
N021200 001 Jul 24, 2002
N021200 002 Jul 24, 2002
N022154 001 Apr 28, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-294( of 322)
TEMAZEPAM
CAPSULE;ORAL
TEMAZ
QUANTUM PHARMICS 15MG A070564 001 Oct 15, 1985
30MG A070547 001 Oct 15, 1985
TEMAZEPAM
DURAMED PHARMS BARR 15MG A071708 001 Sep 29, 1988
30MG A071709 001 Sep 29, 1988
MUTUAL PHARM 15MG A071174 001 Jul 10, 1986
30MG A071175 001 Jul 10, 1986
USL PHARMA 15MG A070489 001 Jul 07, 1986
30MG A070490 001 Jul 07, 1986
WATSON LABS 15MG A070383 001 Mar 23, 1987
30MG A070384 001 Mar 23, 1987
TERAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
TERAZOSIN HYDROCHLORIDE
MYLAN TECHNOLOGIES EQ 1MG BASE A075384 001 Dec 01, 2000
EQ 2MG BASE A075384 002 Dec 01, 2000
EQ 5MG BASE A075384 003 Dec 01, 2000
EQ 10MG BASE A075384 004 Dec 01, 2000
RANBAXY LABS LTD EQ 1MG BASE A076021 001 Aug 22, 2002
EQ 2MG BASE A076021 002 Aug 22, 2002
EQ 5MG BASE A076021 003 Aug 22, 2002
EQ 10MG BASE A076021 004 Aug 22, 2002
SANDOZ EQ 1MG BASE A075667 001 Jul 28, 2000
EQ 2MG BASE A075667 002 Jul 28, 2000
EQ 5MG BASE A075667 003 Jul 28, 2000
EQ 10MG BASE A075667 004 Jul 28, 2000
TABLET;ORAL
TERAZOSIN HYDROCHLORIDE
IVAX SUB TEVA PHARMS EQ 1MG BASE A074530 001 Apr 21, 2000
EQ 2MG BASE A074530 002 Apr 21, 2000
EQ 5MG BASE A074530 003 Apr 21, 2000
EQ 10MG BASE A074530 004 Apr 21, 2000
SANDOZ EQ 1MG BASE A074315 001 Dec 31, 1998
EQ 1MG BASE A074657 001 Apr 28, 2000
EQ 2MG BASE A074315 002 Dec 31, 1998
EQ 2MG BASE A074657 002 Apr 28, 2000
EQ 5MG BASE A074315 003 Dec 31, 1998
EQ 5MG BASE A074657 003 Apr 28, 2000
EQ 10MG BASE A074315 004 Dec 31, 1998
EQ 10MG BASE A074657 004 Apr 28, 2000
TEVA EQ 1MG BASE A074446 001 May 18, 2000
EQ 2MG BASE A074446 002 May 18, 2000
EQ 5MG BASE A074446 003 May 18, 2000
EQ 10MG BASE A074446 004 May 18, 2000
TERBINAFINE
GEL;TOPICAL
LAMISIL
NOVARTIS 1% N020846 001 Apr 29, 1998
TERBINAFINE HYDROCHLORIDE
CREAM;TOPICAL
LAMISIL
NOVARTIS 1% N020192 001 Dec 30, 1992
SOLUTION;TOPICAL
LAMISIL
NOVARTIS 1% N020749 001 Oct 17, 1997
TABLET;ORAL
TERBINAFINE HYDROCHLORIDE
GEDEON RICHTER USA EQ 250MG BASE A077065 001 Jul 02, 2007
MYLAN EQ 250MG BASE A077136 001 Jul 02, 2007
ROXANE EQ 250MG BASE A077223 001 Jul 02, 2007
TERBUTALINE SULFATE
AEROSOL, METERED;INHALATION
BRETHAIRE
NOVARTIS 0.2MG/INH N018762 001 Aug 17, 1984
BRICANYL
SANOFI AVENTIS US 0.2MG/INH N018000 001 Mar 19, 1985
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
TERBUTALINE SULFATE
INJECTABLE;INJECTION
BRETHINE
AAIPHARMA LLC
BRICANYL
SANOFI AVENTIS US
TERBUTALINE SULFATE
TEVA PHARMS USA
TABLET;ORAL
BRETHINE
LEHIGH VALLEY
BRICANYL
SANOFI AVENTIS US
TERCONAZOLE
SUPPOSITORY;VAGINAL
TERCONAZOLE
FOUGERA PHARMS
TARO
TERIPARATIDE ACETATE
INJECTABLE;INJECTION
PARATHAR
SANOFI AVENTIS US
TERIPARATIDE RECOMBINANT HUMAN
INJECTABLE;SUBCUTANEOUS
FORTEO
LILLY
TESAMORELIN ACETATE
POWDER;SUBCUTANEOUS
EGRIFTA
EMD SERONO
TESTOLACTONE
INJECTABLE;INJECTION
TESLAC
BRISTOL MYERS SQUIBB
TABLET;ORAL
TESLAC
BRISTOL MYERS SQUIBB
TESTOSTERONE
1MG/ML
1MG/ML
1MG/ML
2.5MG
5MG
2.5MG
5MG
80MG
80MG
200 UNITS/VIAL
0.75MG/3ML (0.25MG/ML)
EQ 1MG BASE/VIAL
100MG/ML
50MG
250MG
FILM, EXTENDED RELEASE;TRANSDERMAL
ANDRODERM
WATSON LABS
TESTODERM
ALZA
TESTODERM TTS
ALZA
GEL;TRANSDERMAL
TESTOSTERONE
PAR PHARM
WATSON LABS
INJECTABLE;INJECTION
TESTOSTERONE
WATSON LABS
TESTOSTERONE CYPIONATE
INJECTABLE;INJECTION
DEPO-TESTOSTERONE
PHARMACIA AND UPJOHN
TESTOSTERONE CYPIONATE
WATSON LABS
2.5MG/24HR
5MG/24HR
4MG/24HR
6MG/24HR
5MG/24HR
1% (2.5GM/PACKET)
1% (5GM/PACKET)
1% (2.5GM/PACKET)
1% (5GM/PACKET)
25MG/ML
50MG/ML
100MG/ML
50MG/ML
100MG/ML
100MG/ML
200MG/ML
6-295( of 322)
N018571 001
N017466 001
A076853 001 Jul 20, 2004
N017849 001
N017849 002
N017618 001
N017618 002
A076850 001 Jul 12, 2006
A077553 001 Mar 09, 2007
N019498 001 Dec 23, 1987
N021318 001 Nov 26, 2002
N022505 001 Nov 10, 2010
N016119 001
N016118 001
N016118 002
N020489 001 Sep 29, 1995
N020489 002 May 02, 1997
N019762 001 Oct 12, 1993
N019762 002 Oct 12, 1993
N020791 001 Dec 18, 1997
A076744 001 May 23, 2007
A076744 002 May 23, 2007
A076737 001 Jan 27, 2006
A076737 002 Jan 27, 2006
A086420 001 May 10, 1983
A086419 001 Aug 23, 1983
A086417 001 Jul 07, 1983
A085635 001
A084401 001
A086029 001
A084401 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-296( of 322)
N009165 001
A083667 001
A085599 001
A083667 002
A080741 001
A080742 001
A080743 001
A080276 001
A080254 002
A080188 001
A085490 001
A080188 002
A085490 002
A080188 003
A083595 003
A061658 001
A061888 001
A061658 002
A061888 002
A061725 001
A062175 001
A062332 001
A061725 002
A062332 002
A060347 001
A061443 001
A061443 002
A061734 001
A061734 002
A060429 002
A060429 004
A060429 001
A060429 003
A060343 001
A060343 003
A061802 001
A061802 002
A060059 001
A060173 001
A060173 002
A061148 001
A061148 002
A062752 001 Aug 12, 1988
A062752 002 Aug 12, 1988
A062085 001
A060736 001
A060736 002
A060783 001
A060783 002
A060290 001
A060290 002
A062686 001 Jul 24, 1986
A062686 002 Jul 24, 1986
A061214 002
TESTOSTERONE ENANTHATE
INJECTABLE;INJECTION
DELATESTRYL
ENDO PHARMS
TESTOSTERONE ENANTHATE
WATSON LABS
TESTOSTERONE PROPIONATE
INJECTABLE;INJECTION
TESTOSTERONE PROPIONATE
BEL MAR
ELKINS SINN
LILLY
WATSON LABS
TETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
BRISTACYCLINE
BRISTOL
CYCLOPAR
WARNER CHILCOTT
PANMYCIN
PHARMACIA AND UPJOHN
RETET
SOLVAY
ROBITET
WYETH AYERST
SUMYCIN
APOTHECON
TETRACHEL
ANGUS
TETRACYCLINE HYDROCHLORIDE
ABBOTT
ELKINS SINN
FERRANTE
HEATHER
LABS ATRAL
MAST MM
MUTUAL PHARM
MYLAN
PUREPAC PHARM
PVT FORM
ROXANE
200MG/ML
100MG/ML
100MG/ML
200MG/ML
25MG/ML
50MG/ML
100MG/ML
25MG/ML
50MG/ML
25MG/ML
25MG/ML
50MG/ML
50MG/ML
100MG/ML
100MG/ML
250MG
250MG
500MG
500MG
250MG
250MG
250MG
500MG
500MG
250MG
250MG
500MG
250MG
500MG
100MG
125MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
125MG
250MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
500MG
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-297( of 322)
A061471 001
A062540 001 Mar 21, 1985
A062540 002 Mar 21, 1985
A060471 001
A060471 002
A062300 001
A062300 002
A062103 001
A062343 001
A062103 002
A062343 002
A060768 001
A060768 002
A061685 001
A061685 002
A060082 003
A060082 004
N050653 001 Mar 25, 1994
N050493 001
N050273 002
N050273 003
A060096 001
A060096 002
N050266 001
N050263 002
A060400 001
A060633 001
A060174 001
A060446 001
A060291 001
A060095 001
A061468 001
N050268 001
A061705 001
A061705 002
A061147 003
A061147 002
A061147 001
A061147 004
A061653 001
A061653 002
A061889 002
N050212 002
A061653 003
A061889 001
TETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
TETRACYCLINE HYDROCHLORIDE
SANDOZ
SUPERPHARM
VALEANT PHARM INTL
WARNER CHILCOTT
WATSON LABS
WEST WARD
WYETH AYERST
TETRACYN
PFIPHARMECS
FIBER, EXTENDED RELEASE;PERIODONTAL
250MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
ACTISITE
SCHIFF AND CO
FOR SOLUTION;TOPICAL
TOPICYCLINE
SHIRE
INJECTABLE;INJECTION
ACHROMYCIN
LEDERLE
TETRACYN
PFIZER
OINTMENT;OPHTHALMIC
ACHROMYCIN
STORZ
SUSPENSION;ORAL
ACHROMYCIN V
LEDERLE
SUMYCIN
PAR PHARM
TETRACYCLINE HYDROCHLORIDE
ALPHARMA US PHARMS
FERRANTE
PROTER
PUREPAC PHARM
TETRACYN
PFIPHARMECS
TETRAMED
IVAX SUB TEVA PHARMS
SUSPENSION/DROPS;OPHTHALMIC
ACHROMYCIN
STORZ
TABLET;ORAL
PANMYCIN
PHARMACIA AND UPJOHN
SUMYCIN
PAR PHARM
TETRACYCLINE PHOSPHATE COMPLEX
CAPSULE;ORAL
TETREX
BRISTOL
12.7MG/FIBER
2.2MG/ML
250MG/VIAL
500MG/VIAL
250MG/VIAL
500MG/VIAL
10MG/GM
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
1%
250MG
500MG
50MG
100MG
250MG
500MG
EQ 100MG HCL
EQ 250MG HCL
EQ 250MG HCL
EQ 250MG HCL
EQ 500MG HCL
EQ 500MG HCL
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-298( of 322)
TETRACYCLINE PHOSPHATE COMPLEX
CAPSULE;ORAL
TETREX
EQ 500MG HCL N050212 003
THALLOUS CHLORIDE TL-201
INJECTABLE;INJECTION
THALLOUS CHLORIDE TL 201
BRACCO 1mCi/ML N018548 001 Dec 30, 1982
TRACE LIFE 1mCi/ML A075569 001 Nov 21, 2001
INJECTABLE;INTRAVENOUS
THALLOUS CHLORIDE TL 201
MALLINCKRODT 2mCi/ML A077698 001 Nov 09, 2006
THEOPHYLLINE
CAPSULE;ORAL
BRONKODYL
SANOFI AVENTIS US 100MG A085264 001
200MG A085264 002
ELIXOPHYLLIN
FOREST LABS 100MG A085545 001 Jul 31, 1984
200MG A083921 001 Jul 31, 1984
SOMOPHYLLIN-T
FISONS 100MG A087155 001 Feb 25, 1985
200MG A087155 002 Feb 25, 1985
250MG A087155 003 Feb 25, 1985
THEOPHYLLINE
KV PHARM 100MG A085263 001
200MG A085263 002
SCHERER RP 100MG A084731 002 Nov 07, 1986
200MG A084731 001 Nov 07, 1986
250MG A084731 003 Nov 07, 1986
CAPSULE, EXTENDED RELEASE;ORAL
AEROLATE III
FLEMING PHARMS 65MG A085075 003 Nov 24, 1986
AEROLATE JR
FLEMING PHARMS 130MG A085075 002 Nov 24, 1986
AEROLATE SR
FLEMING PHARMS 260MG A085075 001 Nov 24, 1986
ELIXOPHYLLIN SR
FOREST LABS 125MG A086826 001 Jan 29, 1985
250MG A086826 002 Jan 29, 1985
SLO-BID
SANOFI AVENTIS US 50MG A088269 001 Jan 31, 1985
75MG A089539 001 May 10, 1989
100MG A087892 001 Jan 31, 1985
125MG A089540 001 May 10, 1989
200MG A087893 001 Jan 31, 1985
300MG A087894 001 Jan 31, 1985
SLO-PHYLLIN
SANOFI AVENTIS US 60MG A085206 001 May 24, 1982
125MG A085203 001 May 24, 1982
250MG A085205 001 May 24, 1982
SOMOPHYLLIN-CRT
GRAHAM DM 50MG A087763 001 Feb 27, 1985
100MG A087194 001
200MG A088382 001 Feb 27, 1985
250MG A087193 001
300MG A088383 001 Feb 27, 1985
THEO-DUR
SCHERING 50MG A088022 001 Sep 10, 1985
75MG A088015 001 Sep 10, 1985
125MG A088016 001 Sep 10, 1985
200MG A087995 001 Sep 10, 1985
THEOBID
WHITBY 260MG A085983 001 Mar 20, 1985
THEOBID JR.
WHITBY 130MG A087854 001 Mar 20, 1985
THEOCLEAR L.A.-130
SCHWARZ PHARMA 130MG A086569 001 May 27, 1982
THEOCLEAR L.A.-260
SCHWARZ PHARMA 260MG A086569 002 May 27, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-299( of 322)
THEOPHYLLINE
CAPSULE, EXTENDED RELEASE;ORAL
THEOPHYL-SR
ORTHO MCNEIL PHARM 125MG A086480 001 Feb 08, 1985
250MG A086471 001 Feb 08, 1985
THEOPHYLLINE
CENT PHARMS 125MG A088654 001 Feb 12, 1985
250MG A088689 001 Feb 12, 1985
HOSPIRA 100MG A089976 001 Jan 04, 1995
200MG A089977 001 Jan 04, 1995
300MG A089932 001 Jan 04, 1995
INWOOD LABS 100MG A040052 001 Feb 14, 1994
125MG A040052 002 Feb 14, 1994
200MG A040052 003 Feb 14, 1994
300MG A040052 004 Feb 14, 1994
SANDOZ 260MG A087462 001 May 11, 1982
THEOPHYLLINE-SR
SCHERER RP 300MG A088255 001 Jun 12, 1986
THEOVENT
SCHERING 125MG A087010 001 Jan 31, 1985
250MG A087910 001 Jan 31, 1985
ELIXIR;ORAL
ELIXOMIN
CENCI 80MG/15ML A088303 001 Jan 25, 1984
LANOPHYLLIN
LANNETT 80MG/15ML A084578 001
THEOLIXIR
PANRAY 80MG/15ML A084559 001
THEOPHYL-225
ORTHO MCNEIL PHARM 112.5MG/15ML A086485 001
THEOPHYLLINE
ALPHARMA US PHARMS 80MG/15ML A089223 001 May 27, 1988
CENCI 80MG/15ML A087679 001 Apr 15, 1982
HALSEY 80MG/15ML A085169 001
PERRIGO 80MG/15ML A085952 001
PHARM ASSOC 80MG/15ML A086720 001
PRECISION DOSE 80MG/15ML A085863 001
ROXANE 80MG/15ML A084739 001
TARO 80MG/15ML A089626 001 Oct 28, 1988
WOCKHARDT 80MG/15ML A086748 001
INJECTABLE;INJECTION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 40MG/100ML N019083 001 Nov 07, 1984
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 80MG/100ML N019083 002 Nov 07, 1984
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 160MG/100ML N019083 003 Nov 07, 1984
THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 200MG/100ML N019212 001 Nov 07, 1984
200MG/100ML N019826 004 Aug 14, 1992
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 4MG/ML N019212 003 Nov 07, 1984
400MG/100ML N019212 002 Nov 07, 1984
400MG/100ML N019826 005 Aug 14, 1992
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4MG/ML N018649 007 Jul 26, 1982
40MG/100ML N018649 001 Jul 26, 1982
80MG/100ML N018649 002 Jul 26, 1982
160MG/100ML N018649 003 Jul 26, 1982
200MG/100ML N018649 004 Jul 26, 1982
320MG/100ML N018649 006 Nov 13, 1985
400MG/100ML N018649 005 Jul 26, 1982
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA INC 80MG/100ML N019211 002 Dec 14, 1984
200MG/100ML N019211 004 Dec 14, 1984
400MG/100ML N019211 005 Dec 14, 1984
SOLUTION;ORAL
AEROLATE
FLEMING PHARMS 150MG/15ML A089141 001 Dec 03, 1986
THEOLAIR
3M 80MG/15ML A086107 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-300( of 322)
THEOPHYLLINE
SOLUTION;ORAL
THEOPHYLLINE
ROXANE
SUSPENSION;ORAL
ELIXICON
FOREST LABS
SYRUP;ORAL
ACCURBRON
SANOFI AVENTIS US
AQUAPHYLLIN
FERNDALE LABS
SLO-PHYLLIN
SANOFI AVENTIS US
THEOCLEAR-80
CENT PHARMS
THEOPHYLLINE
ALPHARMA US PHARMS
TABLET;ORAL
QUIBRON-T
MONARCH PHARMS
SLO-PHYLLIN
SANOFI AVENTIS US
THEOCLEAR-100
CENT PHARMS
THEOCLEAR-200
CENT PHARMS
THEOPHYL-225
ORTHO MCNEIL PHARM
TABLET, CHEWABLE;ORAL
THEOPHYL
ORTHO MCNEIL PHARM
TABLET, EXTENDED RELEASE;ORAL
DURAPHYL
FOREST LABS
LABID
WARNER CHILCOTT
QUIBRON-T/SR
MONARCH PHARMS
SUSTAIRE
ROERIG
T-PHYL
PHARM RES ASSOC
THEO-DUR
SCHERING
THEOLAIR-SR
3M
THEOPHYLLINE
ABLE
INWOOD LABS
UNI-DUR
SCHERING
80MG/15ML
100MG/5ML
150MG/15ML
80MG/15ML
80MG/15ML
80MG/15ML
80MG/15ML
150MG/15ML
300MG
100MG
200MG
100MG
200MG
225MG
100MG
100MG
200MG
300MG
250MG
300MG
100MG
300MG
200MG
100MG
200MG
300MG
450MG
200MG
250MG
300MG
500MG
300MG
400MG
450MG
600MG
450MG
400MG
600MG
A087449 001 Sep 15, 1983
A085502 001
A088746 001 Nov 22, 1985
A087917 001 Jan 18, 1983
A085187 001
A087095 001 Mar 01, 1982
A086001 001
A086545 001
A088656 001 Aug 22, 1985
A085202 001
A085204 001
A085353 002
A085353 001
A084726 001
A086506 001 Sep 12, 1985
A088503 001 Apr 03, 1985
A088504 001 Apr 03, 1985
A088505 001 Apr 03, 1985
A087225 001
A087563 001 Jun 21, 1983
A085665 001
A085665 002
A088253 001 Aug 17, 1983
A085328 001
A086998 001
A085328 002
A089131 001 Jun 25, 1986
A088369 001 Jul 16, 1987
A086363 002 Jul 16, 1987
A088364 001 Jul 16, 1987
A089132 001 Jul 16, 1987
A040548 001 Apr 30, 2004
A040543 001 Apr 27, 2004
A040546 001 Apr 30, 2004
A040539 001 Apr 27, 2004
A040034 001 Apr 28, 1995
A089822 001 Jan 04, 1995
A089823 001 Jan 04, 1995
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-301( of 322)
N006333 008
A085148 001
N016097 001
N016096 001
A080853 001
A080509 001
A087968 001 Oct 01, 1982
A080718 001
A080712 001
A083775 001
A080575 001
A040079 001 May 03, 1996
A080667 001
A080770 001
A083534 001
A083534 002
A080553 001
N007600 003
N007600 005
N007600 009
N012754 002
N013247 001
N012753 001
N011679 001
N017923 001
N017923 002
N011808 012
N011808 018
A088229 001 Aug 23, 1983
A087766 001 Apr 26, 1983
A040125 001 Aug 16, 1996
A040126 001 Aug 16, 1996
A040187 001 Aug 28, 1997
THEOPHYLLINE SODIUM GLYCINATE
ELIXIR;ORAL
SYNOPHYLATE
CENT PHARMS
TABLET;ORAL
ASBRON
NOVARTIS
THIABENDAZOLE
SUSPENSION;ORAL
MINTEZOL
MERCK SHARP DOHME
TABLET, CHEWABLE;ORAL
MINTEZOL
MERCK SHARP DOHME
THIAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
BETALIN S
LILLY
THIAMINE HYDROCHLORIDE
ABRAXIS PHARM
AKORN
BEL MAR
DELL LABS
HIKMA MAPLE
HOSPIRA
LUITPOLD
PARKE DAVIS
WATSON LABS
WYETH AYERST
THIAMYLAL SODIUM
INJECTABLE;INJECTION
SURITAL
PARKEDALE
THIETHYLPERAZINE MALATE
INJECTABLE;INJECTION
TORECAN
NOVARTIS
THIETHYLPERAZINE MALEATE
SUPPOSITORY;RECTAL
TORECAN
NOVARTIS
TABLET;ORAL
TORECAN
NOVARTIS
THIOPENTAL SODIUM
SUSPENSION;RECTAL
PENTOTHAL
ABBOTT
THIORIDAZINE
SUSPENSION;ORAL
MELLARIL-S
NOVARTIS
THIORIDAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
MELLARIL
NOVARTIS
THIORIDAZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC
ALPHARMA US PHARMS
HI TECH PHARMA
PHARM ASSOC
EQ 165MG BASE/15ML
EQ 150MG BASE
500MG/5ML
500MG
100MG/ML
100MG/ML
100MG/ML
100MG/ML
200MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
200MG/ML
100MG/ML
1GM/VIAL
5GM/VIAL
10GM/VIAL
5MG/ML
10MG
10MG
400MG/GM
EQ 25MG HCL/5ML
EQ 100MG HCL/5ML
30MG/ML
100MG/ML
100MG/ML
30MG/ML
30MG/ML
100MG/ML
30MG/ML
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
THIORIDAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
THIORIDAZINE HYDROCHLORIDE
100MG/ML
SANDOZ 30MG/ML
100MG/ML
TEVA PHARMS 30MG/ML
100MG/ML
WOCKHARDT 30MG/ML
100MG/ML
THIORIDAZINE HYDROCHLORIDE INTENSOL
ROXANE 30MG/ML
100MG/ML
TABLET;ORAL
MELLARIL
NOVARTIS 10MG
15MG
25MG
50MG
100MG
150MG
200MG
THIORIDAZINE HYDROCHLORIDE
IVAX PHARMS 10MG
15MG
25MG
50MG
100MG
MUTUAL PHARM 10MG
15MG
25MG
50MG
100MG
150MG
200MG
MYLAN 10MG
25MG
50MG
100MG
PAR PHARM 10MG
15MG
25MG
50MG
100MG
150MG
200MG
ROXANE 10MG
25MG
50MG
100MG
SANDOZ 10MG
15MG
25MG
50MG
100MG
150MG
200MG
SUPERPHARM 10MG
25MG
50MG
TEVA 10MG
100MG
WATSON LABS 10MG
10MG
10MG
15MG
15MG
15MG
25MG
25MG
25MG
25MG
6-302( of 322)
A040213 001 May 29, 1998
A088307 001 Nov 23, 1983
A088308 001 Nov 23, 1983
A089602 001 Nov 09, 1987
A089603 001 Nov 09, 1987
A088258 001 Jul 25, 1983
A088227 001 Jul 05, 1983
A088941 001 Dec 16, 1985
A088942 001 Dec 16, 1985
N011808 003
N011808 016
N011808 006
N011808 011
N011808 009
N011808 017
N011808 015
A088270 001 Apr 14, 1983
A088271 001 Apr 14, 1983
A088272 001 Apr 14, 1983
A088194 001 Apr 14, 1983
A088273 001 Oct 03, 1983
A088375 001 Nov 18, 1983
A088461 001 Nov 18, 1983
A087264 001 Nov 18, 1983
A088370 001 Nov 18, 1983
A088379 001 Nov 16, 1983
A088737 001 Sep 26, 1984
A088738 001 Oct 16, 1984
A088332 001 Jun 27, 1983
A088333 001 Jun 27, 1983
A088334 001 Jun 27, 1983
A088335 001 Nov 18, 1983
A088351 001 Dec 05, 1983
A088352 001 Dec 05, 1983
A088336 001 Dec 05, 1983
A088322 001 Dec 05, 1983
A088480 001 Dec 29, 1983
A089764 001 Feb 09, 1988
A089765 001 Feb 09, 1988
A088663 001 Mar 15, 1984
A088664 001 Mar 15, 1984
A088665 001 Mar 15, 1984
A089048 001 Feb 26, 1985
A088131 001 Aug 30, 1983
A088132 001 Aug 30, 1983
A088133 001 Aug 30, 1983
A088134 001 Aug 30, 1983
A088135 001 Nov 20, 1984
A088136 001 Sep 17, 1986
A088137 001 Sep 17, 1986
A089103 001 Jul 02, 1985
A089104 001 Jul 02, 1985
A089105 001 Jul 02, 1985
A088493 001 May 17, 1985
A088456 001 May 17, 1985
A088412 001 Sep 12, 1983
A088476 001 Nov 08, 1983
A088561 001 May 11, 1984
A088345 001 Jul 28, 1983
A088477 001 Nov 08, 1983
A088562 001 May 11, 1984
A088296 001 Jul 28, 1983
A088478 001 Nov 08, 1983
A088567 001 May 11, 1984
A088755 001 Jul 24, 1984
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-303( of 322)
THIORIDAZINE HYDROCHLORIDE
TABLET;ORAL
THIORIDAZINE HYDROCHLORIDE
50MG A088323 001 Jul 28, 1983
50MG A088479 001 Nov 08, 1983
50MG A088563 001 May 11, 1984
100MG A088284 001 Aug 25, 1983
100MG A088564 001 May 11, 1984
100MG A088736 001 Jul 24, 1984
150MG A088410 001 Mar 05, 1984
150MG A088869 001 Jun 28, 1985
200MG A088381 001 Mar 14, 1984
200MG A088872 001 Apr 26, 1985
WEST WARD 10MG A088658 001 Mar 26, 1984
15MG A088659 001 Mar 26, 1984
25MG A088660 001 Mar 26, 1984
50MG A088661 001 Mar 26, 1984
THIOTEPA
INJECTABLE;INJECTION
THIOPLEX
IMMUNEX 15MG/VIAL N020058 001 Dec 22, 1994
THIOTEPA
FRESENIUS KABI USA 15MG/VIAL A075698 001 Sep 20, 2001
IMMUNEX 15MG/VIAL N011683 001
TEVA PARENTERAL 15MG/VIAL A075730 001 Apr 20, 2001
30MG/VIAL A075730 002 Apr 20, 2001
THIOTHIXENE
CAPSULE;ORAL
NAVANE
PFIZER 20MG N016584 005
THIOTHIXENE
AM THERAP 1MG A071884 001 Aug 12, 1987
2MG A071885 001 Aug 12, 1987
5MG A071886 001 Aug 12, 1987
10MG A071887 001 Aug 12, 1987
20MG A072200 001 Dec 17, 1987
WATSON LABS 1MG A070600 001 Jun 05, 1987
2MG A071626 001 Jun 25, 1987
5MG A071627 001 Jun 25, 1987
10MG A070603 001 Jun 05, 1987
10MG A071628 001 Jun 25, 1987
THIOTHIXENE HYDROCHLORIDE
CONCENTRATE;ORAL
NAVANE
PFIZER EQ 5MG BASE/ML N016758 001
THIOTHIXENE HYDROCHLORIDE
ALPHARMA US PHARMS EQ 5MG BASE/ML A070969 001 Oct 16, 1987
PACO EQ 1MG BASE/ML A071917 001 Sep 20, 1989
EQ 5MG BASE/ML A071939 001 Dec 16, 1988
TEVA EQ 5MG BASE/ML A071184 001 Jun 22, 1987
TEVA PHARMS EQ 5MG BASE/ML A071554 001 Oct 16, 1987
THIOTHIXENE HYDROCHLORIDE INTENSOL
ROXANE EQ 5MG BASE/ML A073494 001 Jun 30, 1992
INJECTABLE;INJECTION
NAVANE
PFIZER EQ 2MG BASE/ML N016904 001
EQ 10MG BASE/VIAL N016904 002
THYROGLOBULIN
TABLET;ORAL
PROLOID
PARKE DAVIS 16MG N002245 009
32MG N002245 005
65MG N002245 002
100MG N002245 008
130MG N002245 010
200MG N002245 007
325MG N002245 004
THYROGLOBULIN
IMPAX LABS 64.8MG A080151 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
THYROTROPIN
INJECTABLE;INJECTION
THYTROPAR
SANOFI AVENTIS US 10 IU/VIAL
TIAGABINE HYDROCHLORIDE
TABLET;ORAL
GABITRIL
CEPHALON 6MG
8MG
10MG
20MG
TICARCILLIN DISODIUM
INJECTABLE;INJECTION
TICAR
GLAXOSMITHKLINE EQ 1GM BASE/VIAL
EQ 3GM BASE/VIAL
EQ 3GM BASE/VIAL
EQ 6GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 30GM BASE/VIAL
TICLOPIDINE HYDROCHLORIDE
TABLET;ORAL
TICLID
ROCHE PALO 125MG
250MG
TICLOPIDINE HYDROCHLORIDE
ACTAVIS ELIZABETH 250MG
MYLAN 250MG
250MG
SANDOZ 250MG
250MG
WATSON LABS 250MG
TILUDRONATE DISODIUM
TABLET;ORAL
SKELID
SANOFI AVENTIS US EQ 200MG BASE
TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC
TIMOLOL MALEATE
AKORN EQ 0.25% BASE
EQ 0.25% BASE
APOTEX INC EQ 0.25% BASE
EQ 0.5% BASE
FOUGERA EQ 0.25% BASE
EQ 0.5% BASE
TABLET;ORAL
BLOCADREN
MERCK 5MG
10MG
20MG
TIMOLOL MALEATE
QUANTUM PHARMICS 5MG
10MG
20MG
SANDOZ 5MG
10MG
20MG
TEVA 5MG
10MG
20MG
USL PHARMA 5MG
10MG
20MG
WATSON LABS 5MG
5MG
10MG
10MG
20MG
20MG
6-304( of 322)
N008682 001
N020646 006 Nov 29, 2005
N020646 007 Nov 29, 2005
N020646 008 Nov 29, 2005
N020646 004 Sep 30, 1997
N050497 001
A062690 001 Dec 19, 1986
N050497 002
N050497 003
N050497 004
N050497 005 Apr 04, 1984
N019979 001 Mar 24, 1993
N019979 002 Oct 31, 1991
A075253 001 Aug 20, 1999
A075161 001 Sep 13, 1999
A075316 001 Nov 02, 1999
A075318 001 Aug 20, 1999
A075326 001 Aug 20, 1999
A075309 001 Apr 26, 2000
N020707 001 Mar 07, 1997
A074465 001 Mar 25, 1997
A074515 001 Mar 25, 1997
A075411 001 Sep 08, 2000
A075412 001 Sep 08, 2000
A074667 001 Mar 25, 1997
A074668 001 Mar 25, 1997
N018017 001
N018017 002
N018017 004
A072466 001 May 19, 1989
A072467 001 May 19, 1989
A072468 001 May 19, 1989
A072550 001 Apr 13, 1989
A072551 001 Apr 13, 1989
A072552 001 Apr 13, 1989
A072648 001 Jun 16, 1993
A072649 001 Jun 16, 1993
A072650 001 Jun 16, 1993
A072001 001 Apr 11, 1989
A072002 001 Apr 11, 1989
A072003 001 Apr 11, 1989
A072269 001 Apr 11, 1989
A072917 001 Jul 31, 1991
A072270 001 Apr 11, 1989
A072918 001 Jul 31, 1991
A072271 001 Apr 11, 1989
A072919 001 Jul 31, 1991
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-305( of 322)
TINZAPARIN SODIUM
INJECTABLE;INJECTION
INNOHEP
LEO PHARMA AS 20,000 IU/ML N020484 001 Jul 14, 2000
TIOCONAZOLE
CREAM;TOPICAL
TZ-3
PFIZER 1% N018682 001 Feb 18, 1983
TIROFIBAN HYDROCHLORIDE
INJECTABLE;INJECTION
AGGRASTAT
MEDICURE EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) N020912 001 May 14, 1998
EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) N020913 001 May 14, 1998
TIZANIDINE HYDROCHLORIDE
TABLET;ORAL
TIZANIDINE HYDROCHLORIDE
ACTAVIS ELIZABETH EQ 2MG BASE A076283 001 Jul 12, 2002
EQ 4MG BASE A076283 002 Jul 12, 2002
BARR EQ 2MG BASE A076371 001 Apr 09, 2003
EQ 4MG BASE A076371 002 Apr 09, 2003
IVAX SUB TEVA PHARMS EQ 2MG BASE A076321 001 Sep 30, 2004
EQ 4MG BASE A076321 002 Sep 30, 2004
MYLAN PHARMS INC EQ 2MG BASE A076282 001 Dec 16, 2003
EQ 4MG BASE A076282 002 Dec 16, 2003
ZANAFLEX
ACORDA EQ 2MG BASE N020397 002 Feb 04, 2000
TOBRAMYCIN
SOLUTION/DROPS;OPHTHALMIC
TOBRAMYCIN
ALCON PHARMS LTD 0.3% A063176 001 May 25, 1994
APOTEX INC 0.3% A065087 001 Feb 25, 2002
TOBRAMYCIN SULFATE
INJECTABLE;INJECTION
NEBCIN
LILLY EQ 1.2GM BASE/VIAL N050519 001
EQ 10MG BASE/ML A062008 004
EQ 10MG BASE/ML A062707 001 Apr 29, 1987
EQ 10MG BASE/ML N050477 005
EQ 40MG BASE/ML A062008 001
TOBRAMYCIN SULFATE
APOTHECON EQ 10MG BASE/ML A064021 001 May 31, 1994
EQ 40MG BASE/ML A064021 002 May 31, 1994
EQ 40MG BASE/ML A064026 001 May 31, 1994
ASTRAZENECA EQ 10MG BASE/ML A063119 001 Oct 31, 1994
EQ 40MG BASE/ML A063120 001 Oct 31, 1994
EQ 40MG BASE/ML A063121 001 Oct 31, 1994
EQ 40MG BASE/ML A063122 001 Oct 31, 1994
HIKMA MAPLE EQ 10MG BASE/ML A063113 001 Apr 26, 1991
EQ 10MG BASE/ML A063128 001 Nov 27, 1991
EQ 40MG BASE/ML A063118 001 Jul 29, 1991
EQ 40MG BASE/ML A063127 001 Nov 27, 1991
HOSPIRA EQ 10MG BASE/ML A063080 001 Apr 30, 1991
EQ 40MG BASE/ML A063161 001 May 29, 1991
MARSAM PHARMS LLC EQ 40MG BASE/ML A062945 002 Aug 09, 1989
TOCAINIDE HYDROCHLORIDE
TABLET;ORAL
TONOCARD
ASTRAZENECA 400MG N018257 001 Nov 09, 1984
600MG N018257 002 Nov 09, 1984
TOLAZAMIDE
TABLET;ORAL
TOLAZAMIDE
BARR 100MG A070162 001 Jan 14, 1986
250MG A070163 001 Jan 14, 1986
500MG A070164 001 Jan 14, 1986
DURAMED PHARMS BARR 100MG A070165 001 Jan 10, 1986
250MG A070166 001 Jan 10, 1986
500MG A070167 001 Jan 10, 1986
INTERPHARM 250MG A071270 001 Sep 23, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-306( of 322)
TOLAZAMIDE
TABLET;ORAL
TOLAZAMIDE
500MG A071271 001 Sep 23, 1986
IVAX SUB TEVA PHARMS 100MG N018894 001 Nov 02, 1984
250MG N018894 002 Nov 02, 1984
500MG N018894 003 Nov 02, 1984
MUTUAL PHARM 100MG A071357 001 Jul 16, 1987
250MG A071358 001 Jul 16, 1987
500MG A071359 001 Jul 16, 1987
PAR PHARM 100MG A070159 001 Jan 06, 1986
250MG A070160 001 Jan 06, 1986
500MG A070161 001 Jan 06, 1986
SANDOZ 100MG A071633 001 Dec 09, 1987
250MG A070289 001 Mar 13, 1986
500MG A070290 001 Mar 13, 1986
SUPERPHARM 250MG A070763 001 Jun 16, 1986
500MG A070764 001 Jun 16, 1986
USL PHARMA 100MG A071355 001 Jan 11, 1988
250MG A070168 001 Apr 02, 1986
500MG A070169 001 Apr 02, 1986
WATSON LABS 100MG A070242 001 Aug 01, 1986
100MG A070513 001 Jan 09, 1986
250MG A070243 001 Aug 01, 1986
250MG A070514 001 Jan 09, 1986
500MG A070244 001 Aug 01, 1986
500MG A070515 001 Jan 09, 1986
TOLINASE
PHARMACIA AND UPJOHN 100MG **Federal Register determination N015500 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
250MG N015500 004
500MG N015500 005
TOLAZOLINE HYDROCHLORIDE
INJECTABLE;INJECTION
PRISCOLINE
NOVARTIS 25MG/ML N006403 005 Feb 22, 1985
TOLBUTAMIDE
TABLET;ORAL
ORINASE
PHARMACIA AND UPJOHN 250MG N010670 002
500MG N010670 001
TOLBUTAMIDE
ALRA 500MG A086141 001
ASCOT 500MG A087541 001 Mar 01, 1983
BARR 500MG A087121 001
CLONMEL HLTHCARE 500MG A086926 001
IVAX PHARMS 500MG A087093 001
PARKE DAVIS 500MG A086047 001
PUREPAC PHARM 500MG A088950 001 Jun 17, 1985
SANDOZ 500MG A086574 001
500MG N012678 001
SUPERPHARM 500MG A088893 001 Nov 19, 1984
VANGARD 500MG A087876 001 Apr 20, 1982
WATSON LABS 250MG A089110 001 May 29, 1987
500MG A086109 001
500MG A087318 001
500MG A089111 001 May 29, 1987
TOLBUTAMIDE SODIUM
INJECTABLE;INJECTION
ORINASE DIAGNOSTIC
PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL N012095 001
TOLCAPONE
TABLET;ORAL
TASMAR
VALEANT PHARMS LLC 200MG N020697 002 Jan 29, 1998
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-307( of 322)
TOLMETIN SODIUM
CAPSULE;ORAL
TOLECTIN DS
ORTHO MCNEIL JANSSEN EQ 400MG BASE N018084 001
TOLMETIN SODIUM
ACTAVIS ELIZABETH EQ 400MG BASE A073308 001 Jan 24, 1992
IVAX SUB TEVA PHARMS EQ 400MG BASE A073392 001 Jan 24, 1992
MUTUAL PHARM EQ 400MG BASE A073311 001 Nov 27, 1991
SANDOZ EQ 400MG BASE A073462 001 Apr 30, 1992
TEVA EQ 400MG BASE A073519 001 May 29, 1992
TABLET;ORAL
TOLECTIN
ORTHO MCNEIL JANSSEN EQ 200MG BASE N017628 001
TOLECTIN 600
ORTHO MCNEIL JANSSEN EQ 600MG BASE N017628 002 Mar 08, 1989
TOLMETIN SODIUM
ACTAVIS ELIZABETH EQ 600MG BASE A073527 001 Jun 30, 1992
IVAX SUB TEVA PHARMS EQ 600MG BASE A074399 001 Mar 28, 1996
SANDOZ EQ 200MG BASE A073588 001 Jul 31, 1992
EQ 600MG BASE A074002 001 Sep 27, 1993
TEVA EQ 600MG BASE A074729 001 Feb 27, 1997
TOLVAPTAN
TABLET;ORAL
SAMSCA
OTSUKA AMERICA PHARM 60MG N022275 003 May 19, 2009
TOPIRAMATE
CAPSULE;ORAL
TOPAMAX SPRINKLE
JANSSEN PHARMS 50MG N020844 003 Oct 26, 1998
TOPIRAMATE
BARR 15MG A076448 001 Apr 15, 2009
25MG A076448 002 Apr 15, 2009
SANDOZ 15MG A079206 001 Oct 14, 2009
25MG A079206 002 Oct 14, 2009
TABLET;ORAL
TOPAMAX
JANSSEN PHARMS 300MG N020505 003 Dec 24, 1996
400MG N020505 006 Dec 24, 1996
TOPIRAMATE
BARR 25MG A076315 001 Mar 27, 2009
100MG A076315 002 Mar 27, 2009
200MG A076315 003 Mar 27, 2009
PLIVA HRVATSKA DOO 25MG A077905 001 Mar 30, 2009
50MG A077905 002 Mar 30, 2009
100MG A077905 003 Mar 30, 2009
200MG A077905 004 Mar 30, 2009
ROXANE 25MG A076306 001 Mar 27, 2009
50MG A076306 002 Mar 27, 2009
100MG A076306 003 Mar 27, 2009
200MG A076306 004 Mar 27, 2009
TOPOTECAN HYDROCHLORIDE
SOLUTION;INTRAVENOUS
TOPOTECAN
SANDOZ INC EQ 1MG BASE/ML (EQ 1MG BASE/ML) N200199 001 Feb 25, 2011
EQ 3MG BASE/3ML (EQ 1MG BASE/ML) N200199 002 Feb 25, 2011
EQ 4MG BASE/4ML (EQ 1MG BASE/ML) N200199 003 Feb 25, 2011
TORSEMIDE
INJECTABLE;INJECTION
DEMADEX
ROCHE 50MG/5ML (10MG/ML) N020137 002 Aug 23, 1993
20MG/2ML (10MG/ML) N020137 001 Aug 23, 1993
TRAMADOL HYDROCHLORIDE
TABLET;ORAL
TRAMADOL HYDROCHLORIDE
ACTAVIS ELIZABETH 50MG A075960 001 Jun 19, 2002
ASTA 50MG A075974 001 Jul 12, 2002
IVAX SUB TEVA PHARMS 50MG A075963 001 Jul 03, 2002
SANDOZ 50MG A075968 001 Jun 25, 2002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-308( of 322)
TRAMADOL HYDROCHLORIDE
TABLET;ORAL
ULTRAM
JANSSEN PHARMS 100MG N020281 001 Mar 03, 1995
TABLET, EXTENDED RELEASE;ORAL
RYZOLT
PURDUE PHARMA 100MG **Federal Register determination N021745 001 Dec 30, 2008
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
200MG **Federal Register determination N021745 002 Dec 30, 2008
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
300MG **Federal Register determination N021745 003 Dec 30, 2008
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
TABLET, ORALLY DISINTEGRATING;ORAL
RYBIX ODT
SHIONOGI INC 50MG N021693 001 May 05, 2005
TRANDOLAPRIL
TABLET;ORAL
TRANDOLAPRIL
CIPLA 1MG A077307 002 Jun 12, 2007
2MG A077307 001 Jun 12, 2007
4MG A077307 003 Jun 12, 2007
DR REDDYS LABS LTD 1MG A078493 001 Aug 25, 2008
2MG A078493 002 Aug 25, 2008
4MG A078493 003 Aug 25, 2008
TRANEXAMIC ACID
TABLET;ORAL
CYKLOKAPRON
PHARMACIA AND UPJOHN 500MG N019280 001 Dec 30, 1986
TRAVOPROST
SOLUTION/DROPS;OPHTHALMIC
TRAVATAN
ALCON PHARMS LTD 0.004% N021257 001 Mar 16, 2001
TRAZODONE HYDROCHLORIDE
TABLET;ORAL
DESYREL
APOTHECON 50MG N018207 001
100MG N018207 002
150MG N018207 003 Mar 25, 1985
300MG N018207 004 Nov 07, 1988
TRAZODONE HYDROCHLORIDE
AM THERAP 50MG A071139 001 Oct 29, 1986
100MG A071140 001 Oct 29, 1986
MYLAN 50MG A071405 001 Feb 27, 1991
100MG A071406 001 Feb 27, 1991
QUANTUM PHARMICS 100MG A070921 001 Dec 01, 1986
SANDOZ 50MG A072484 001 Apr 30, 1990
100MG A072483 001 Apr 30, 1990
TEVA 150MG A074357 001 Apr 30, 1997
USL PHARMA 50MG A070491 001 Apr 29, 1987
100MG A070492 001 Apr 29, 1987
WATSON LABS 50MG A071112 001 Nov 17, 1986
100MG A071113 001 Nov 17, 1986
TRIALODINE
QUANTUM PHARMICS 50MG A070942 001 Dec 01, 1986
TRETINOIN
CAPSULE;ORAL
VESANOID
ROCHE 10MG N020438 001 Nov 22, 1995
SOLUTION;TOPICAL
TRETINOIN
TEVA PHARMS 0.05% A074873 001 Jun 19, 1998
SWAB;TOPICAL
RETIN-A
VALEANT INTL 0.05% N016921 002
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-309( of 322)
TRIAMCINOLONE
TABLET;ORAL
ARISTOCORT
ASTELLAS 1MG N011161 009
2MG N011161 004
4MG N011161 007
8MG N011161 011
16MG N011161 010
KENACORT
BRISTOL MYERS SQUIBB 1MG N011283 003
2MG N011283 008
4MG N011283 006
8MG N011283 010
TRIAMCINOLONE
BARR 2MG A084286 001
2MG A084318 001
4MG A084267 001
4MG A084319 001
8MG A084268 001
8MG A084320 001
IMPAX LABS 4MG A084340 001
IVAX SUB TEVA PHARMS 4MG A083750 001
MYLAN 2MG A084406 001
PUREPAC PHARM 2MG A084020 002
4MG A084020 003
ROXANE 2MG A084708 001
4MG A084709 001
8MG A084707 001
SANDOZ 4MG A085601 001
TEVA 4MG A084775 001
WATSON LABS 4MG A084270 001
4MG A085834 001
TRIAMCINOLONE ACETONIDE
AEROSOL, METERED;INHALATION
AZMACORT
ABBVIE 0.1MG/INH N018117 001 Apr 23, 1982
AEROSOL, METERED;NASAL
NASACORT
SANOFI AVENTIS US 0.055MG/INH N019798 001 Jul 11, 1991
CREAM;TOPICAL
ARISTOCORT
ASTELLAS 0.025% A083017 003
0.1% A083016 004
0.5% A083015 002
ARISTOCORT A
ASTELLAS 0.025% A083017 004
0.025% A088818 001 Oct 16, 1984
0.1% A083016 005
0.1% A088819 001 Oct 16, 1984
0.5% A083015 003
0.5% A088820 001 Oct 16, 1984
FLUTEX
IVAX PHARMS 0.025% A085539 001
0.1% A085539 002
0.5% A085539 003
KENALOG
APOTHECON 0.025% **Federal Register determination N011601 003
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
0.1% **Federal Register determination N011601 006
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
0.5% A083943 001
KENALOG-H
APOTHECON 0.1% A086240 001
TRIACET
TEVA 0.025% A084908 001
0.1% A084908 002
0.5% A084908 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-310( of 322)
TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
TRIACORT
SOLVAY 0.1% A087113 001
TRIAMCINOLONE ACETONIDE
ACTAVIS MID ATLANTIC 0.1% A087798 001 Jun 04, 1982
ALPHARMA US PHARMS 0.025% A087797 001 Jun 07, 1982
AMBIX 0.025% A087932 001 May 09, 1983
G AND W LABS 0.025% A089797 001 May 31, 1991
0.1% A089798 001 May 31, 1991
MORTON GROVE 0.025% A088094 001 Sep 01, 1983
0.1% A088095 001 Sep 01, 1983
0.5% A088096 001 Sep 01, 1983
PHARMADERM 0.025% A087990 001 Jul 07, 1983
0.1% A087991 001 Jul 07, 1983
0.5% A087992 001 Jul 07, 1983
PHARMAFAIR 0.025% A087921 001 Aug 10, 1982
0.1% A087912 001 Aug 10, 1982
0.5% A087922 001 Aug 10, 1982
TARO 0.025% A040038 001 Oct 26, 1994
0.025% A086277 001
0.1% A086276 001
0.5% A086275 001
TOPIDERM 0.025% A089274 001 Feb 21, 1989
0.1% A089275 001 Feb 21, 1989
0.5% A089276 001 Feb 21, 1989
TRIATEX
IVAX PHARMS 0.025% A087430 001 Nov 01, 1988
0.1% A087429 001 Nov 01, 1988
0.5% A087428 001 Nov 01, 1988
TRYMEX
SAVAGE LABS 0.025% A088196 001 Mar 25, 1983
0.1% A088197 001 Mar 25, 1983
0.5% A088198 001 Mar 25, 1983
GEL;TOPICAL
ARISTOGEL
ASTELLAS 0.1% A083380 001
INJECTABLE;INJECTION
TRIAMCINOLONE ACETONIDE
PARNELL 3MG/ML N019503 001 Oct 16, 1987
WATSON LABS 40MG/ML A085825 001
INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL
TRIVARIS
ALLERGAN 8MG/0.1ML (8MG/0.1ML) N022220 001 Jun 16, 2008
LOTION;TOPICAL
KENALOG
APOTHECON 0.025% A084343 001
0.1% A084343 002
BRISTOL MYERS SQUIBB 0.025% N011602 003
0.1% N011602 001
TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.025% A087191 001 Sep 08, 1982
0.1% A087192 001 Sep 08, 1982
OINTMENT;TOPICAL
ARISTOCORT
ASTELLAS 0.1% A080750 004
0.5% A080745 002
ARISTOCORT A
ASTELLAS 0.1% A080750 003
0.1% A088780 001 Oct 01, 1984
0.5% A080745 003
0.5% A088781 001 Oct 05, 1984
FLUTEX
IVAX PHARMS 0.025% A087375 001 Nov 01, 1988
0.1% A087377 001 Nov 01, 1988
0.5% A087376 001 Nov 01, 1988
KENALOG
APOTHECON 0.025% N011600 003
0.1% N011600 001
0.5% A083944 001
TRIAMCINOLONE ACETONIDE
ACTAVIS MID ATLANTIC 0.1% A087799 001 Jun 07, 1982
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
TRIAMCINOLONE ACETONIDE
OINTMENT;TOPICAL
TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS
G AND W LABS
MORTON GROVE
PHARMADERM
TARO
TRYMEX
SAVAGE LABS
PASTE;DENTAL
KENALOG IN ORABASE
APOTHECON
ORALONE
TARO
SPRAY, METERED;NASAL
ALLERNAZE
LUPIN ATLANTIS
NASACORT HFA
SANOFI AVENTIS US
TRIAMCINOLONE DIACETATE
INJECTABLE;INJECTION
ARISTOCORT
SANDOZ
TRIAMCINOLONE DIACETATE
AKORN
WATSON LABS
SYRUP;ORAL
ARISTOCORT
ASTELLAS
KENACORT
BRISTOL MYERS SQUIBB
TRIAZOLAM
TABLET;ORAL
HALCION
PHARMACIA AND UPJOHN
TRICHLORMETHIAZIDE
TABLET;ORAL
METAHYDRIN
SANOFI AVENTIS US
NAQUA
SCHERING
TRICHLOREX
LANNETT
TRICHLORMAS
MAST MM
TRICHLORMETHIAZIDE
IMPAX LABS
PAR PHARM
SANDOZ
TG UNITED LABS
WATSON LABS
0.5%
0.025%
0.1%
0.025%
0.1%
0.5%
0.025%
0.1%
0.025%
0.025%
0.1%
0.5%
0.025%
0.1%
0.1%
0.1%
0.05MG/SPRAY
0.055MG/SPRAY
25MG/ML
40MG/ML **Federal Register
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
25MG/ML
40MG/ML
40MG/ML
40MG/ML
2MG/5ML
EQ 4MG BASE/5ML
0.5MG
2MG
4MG
2MG
4MG
4MG
4MG
4MG
4MG
2MG
4MG
4MG
4MG
2MG
2MG
A089913 001
A089795 001
A089796 001
A088090 001
A088091 001
A088092 001
A088692 001
A088690 001
A040040 001
A040374 001
A087902 001
A040386 001
A088693 001
A088691 001
N012097 001
A071383 001
N020120 001
N020784 001
N011685 003
N012802 001
A085122 001
A086394 001
A084072 001
A085529 001
N011960 004
N012515 001
N017892 002
N012594 001
N012594 002
N012265 001
N012265 002
A083436 001
A085630 001
A086259 001
A083967 001
A087007 001
A087005 001
A086171 001
A085568 001
A083847 001
A086458 001
6-311( of 322)
Dec 23, 1988
Dec 23, 1988
Dec 23, 1988
Sep 01, 1983
Sep 01, 1983
Sep 01, 1983
Aug 02, 1984
Aug 02, 1984
Sep 30, 1994
Jun 05, 2001
Dec 27, 1982
Jun 05, 2001
Aug 02, 1984
Aug 02, 1984
Jul 06, 1987
Feb 04, 2000
Apr 07, 2004
Nov 15, 1982
Jun 16, 1988
Jun 16, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
TRICHLORMETHIAZIDE
TABLET;ORAL
TRICHLORMETHIAZIDE
TRICLOFOS SODIUM
SOLUTION;ORAL
TRICLOS
SANOFI AVENTIS US
TABLET;ORAL
TRICLOS
SANOFI AVENTIS US
TRIDIHEXETHYL CHLORIDE
INJECTABLE;INJECTION
PATHILON
LEDERLE
TABLET;ORAL
PATHILON
LEDERLE
TRIFLUOPERAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
STELAZINE
GLAXOSMITHKLINE
TRIFLUOPERAZINE HYDROCHLORIDE
4MG
4MG
4MG
1.5GM/15ML
750MG
10MG/ML
25MG
EQ 10MG BASE/ML
SANDOZ
WOCKHARDT
INJECTABLE;INJECTION
STELAZINE
GLAXOSMITHKLINE
TABLET;ORAL
STELAZINE
GLAXOSMITHKLINE
EQ 10MG BASE/ML
EQ 10MG BASE/ML
EQ 2MG BASE/ML
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
TRIFLUOPERAZINE HYDROCHLORIDE
DURAMED PHARMS BARR
IVAX PHARMS
SANDOZ
WATSON LABS
TRIFLUPROMAZINE
SUSPENSION;ORAL
VESPRIN
APOTHECON
TRIFLUPROMAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
VESPRIN
APOTHECON
TABLET;ORAL
VESPRIN
BRISTOL MYERS SQUIBB
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 50MG HCL/5ML
3MG/ML
10MG/ML
20MG/ML
10MG
25MG
50MG
6-312( of 322)
A083462 001
A083855 001
A085962 001
N016830 001
N016809 002
N009729 001
N009489 005
N011552 006
A085787 001 Apr 15, 1982
A088143 001 Jul 26, 1983
N011552 005
N011552 001
N011552 002
N011552 003
N011552 004
A088967 001 Apr 23, 1985
A088968 001 Apr 23, 1985
A088969 001 Apr 23, 1985
A088970 001 Apr 23, 1985
A087612 001 Nov 19, 1982
A087613 001 Nov 19, 1982
A087328 001 Nov 19, 1982
A087614 001 Nov 19, 1982
A040153 001 Oct 25, 1996
A040153 002 Oct 25, 1996
A040153 003 Oct 25, 1996
A040153 004 Oct 25, 1996
A085975 001 Jun 23, 1988
A085976 001 Jun 23, 1988
A085973 001 Jun 23, 1988
A088710 001 Jun 23, 1988
N011491 004
N011325 005
N011325 004
N011325 001
N011123 001
N011123 002
N011123 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
TRIHEXYPHENIDYL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
ARTANE
LEDERLE 5MG
5MG
ELIXIR;ORAL
ARTANE
LEDERLE 2MG/5ML
TRIHEXYPHENIDYL HYDROCHLORIDE
PHARM VENTURES 2MG/5ML
TABLET;ORAL
ARTANE
LEDERLE 2MG
5MG
TREMIN
SCHERING 2MG
5MG
TRIHEXYPHENIDYL HYDROCHLORIDE
NYLOS 5MG
VANGARD 2MG
WATSON LABS 2MG
5MG
WEST WARD 2MG
5MG
TRILOSTANE
CAPSULE;ORAL
MODRASTANE
BIOENVISION 30MG
60MG
TRIMEPRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
TEMARIL
ALLERGAN HERBERT
SYRUP;ORAL
TEMARIL
ALLERGAN HERBERT
TRIMEPRAZINE TARTRATE
ALPHARMA US PHARMS
MORTON GROVE
TABLET;ORAL
TEMARIL
ALLERGAN HERBERT
TRIMETHADIONE
CAPSULE;ORAL
TRIDIONE
ABBVIE
SOLUTION;ORAL
TRIDIONE
ABBVIE
TRIMETHAPHAN CAMSYLATE
INJECTABLE;INJECTION
ARFONAD
ROCHE
TRIMETHOBENZAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
EQ 5MG BASE
EQ 2.5MG BASE/5ML
EQ 2.5MG BASE/5ML
EQ 2.5MG BASE/5ML
EQ 2.5MG BASE
300MG
200MG/5ML
50MG/ML
TRIMETHOBENZAMIDE HYDROCHLORIDE
HOSPIRA
SMITH AND NEPHEW
SOLOPAK
WATSON LABS
TRIMETHOPRIM
TABLET;ORAL
PROLOPRIM
MONARCH PHARMS
TRIMETHOPRIM
MUTUAL PHARM
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG
200MG
100MG
6-313( of 322)
N006773 010
N012947 001
N006773 009
A089514 001 Apr 07, 1989
N006773 005
N006773 003
A080381 001
A080381 003
A085622 001
A088035 001 Jul 30, 1982
A085117 001
A085105 001
A040337 002 Feb 16, 2000
A040337 001 Feb 16, 2000
N018719 002 Dec 31, 1984
N018719 001 Dec 31, 1984
N011316 004
N011316 003
A085015 001 Feb 18, 1982
A088285 001 Apr 11, 1985
N011316 001
N005856 005
N005856 002
N008983 001
A088804 001 Apr 03, 1987
A088960 001 Apr 04, 1986
A089043 001 Apr 04, 1986
A089094 001 Apr 04, 1986
A086577 001 Oct 19, 1982
A087939 001 Dec 28, 1982
N017943 001
N017943 003 Jul 14, 1982
A070494 001 Jan 22, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
TRIMETHOPRIM
TABLET;ORAL
TRIMETHOPRIM
TEVA
TRIMPEX
ROCHE
TRIMPEX 200
ROCHE
TRIMETHOPRIM HYDROCHLORIDE
SOLUTION;ORAL
PRIMSOL
FSC
TRIMETREXATE GLUCURONATE
INJECTABLE;INJECTION
NEUTREXIN
MEDIMMUNE ONCOLOGY
TRIMIPRAMINE MALEATE
CAPSULE;ORAL
TRIMIPRAMINE MALEATE
USL PHARMA
TRIOXSALEN
TABLET;ORAL
TRISORALEN
VALEANT PHARM INTL
TRIPELENNAMINE CITRATE
ELIXIR;ORAL
PBZ
NOVARTIS
TRIPELENNAMINE HYDROCHLORIDE
TABLET;ORAL
PBZ
NOVARTIS
200MG
200MG
100MG
200MG
EQ 25MG BASE/5ML
EQ 25MG BASE/VIAL
EQ 200MG BASE/VIAL
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
5MG
EQ 25MG HCL/5ML
25MG
50MG
TRIPELENNAMINE HYDROCHLORIDE
ANABOLIC 50MG
BARR 50MG
HEATHER 50MG
IMPAX LABS 50MG
LANNETT 50MG
NYLOS 50MG
PARKE DAVIS 25MG
50MG
WATSON LABS 50MG
50MG
50MG
TABLET, EXTENDED RELEASE;ORAL
PBZ-SR
NOVARTIS 50MG
100MG
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)
CREAM;VAGINAL
GYNE-SULF
G AND W LABS
SULTRIN
ORTHO MCNEIL PHARM
TRIPLE SULFA
ALPHARMA US PHARMS
FOUGERA
PERRIGO NEW YORK
TRYSUL
SAVAGE LABS
VAGILIA
TEVA
2.86%;3.42%;3.7%
2.86%;3.42%;3.7%
2.86%;3.42%;3.7%
2.86%;3.42%;3.7%
2.86%;3.42%;3.7%
2.86%;3.42%;3.7%
3.42%;3.42%;3.42%
6-314( of 322)
A070495 001 Sep 24, 1986
A071259 001 Jun 18, 1987
N017952 001
N017952 002 Nov 09, 1982
A074374 001 Jun 23, 1995
N020326 001 Dec 17, 1993
N020326 002 Jul 31, 1998
A071283 001 Dec 08, 1987
A071284 001 Dec 08, 1987
A071285 001 Dec 08, 1987
N012697 001
N005914 004
A083149 001
N005914 002
A083037 001
A080744 001
A083989 001
A080785 001
A083557 001
A085412 001
A083625 001
A083626 001
A080713 001
A080790 001
A085188 001
N010533 002
N010533 001
A088607 001 Jun 09, 1986
N005794 001
A087864 001 Sep 01, 1982
A086424 001
A087285 001 Nov 15, 1982
A087887 001 Jul 23, 1982
A088821 001 Nov 09, 1987
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)
TABLET;VAGINAL
SULTRIN
ORTHO MCNEIL PHARM
TRIPLE SULFA
FOUGERA
PHARMADERM
TRIPROLIDINE HYDROCHLORIDE
SYRUP;ORAL
ACTIDIL
GLAXOSMITHKLINE
MYIDYL
USL PHARMA
TRIPROLIDINE HYDROCHLORIDE
ALPHARMA US PHARMS
HALSEY
PHARM ASSOC
TABLET;ORAL
ACTIDIL
GLAXOSMITHKLINE
TRIPROLIDINE HYDROCHLORIDE
VITARINE
WATSON LABS
TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)
SUSPENSION;ORAL
LANTRISUL
LANNETT
NEOTRIZINE
LILLY
SULFALOID
FOREST PHARMS
SULFOSE
WYETH AYERST
TERFONYL
BRISTOL MYERS SQUIBB
TRIPLE SULFA
ALPHARMA US PHARMS
TRIPLE SULFAS
LEDERLE
TABLET;ORAL
NEOTRIZINE
LILLY
SULFA-TRIPLE #2
IMPAX LABS
SULFALOID
FOREST PHARMS
SULFOSE
WYETH AYERST
TERFONYL
BRISTOL MYERS SQUIBB
TRIPLE SULFA
PUREPAC PHARM
TRIPLE SULFAS
LEDERLE
TRIPLE SULFOID
PAL PAK
TROGLITAZONE
TABLET;ORAL
PRELAY
SANKYO
REZULIN
PFIZER PHARMS
143.75MG;172.5MG;184MG
172.5MG;172.5MG;172.5MG
172.5MG;172.5MG;172.5MG
1.25MG/5ML
1.25MG/5ML
1.25MG/5ML
1.25MG/5ML
1.25MG/5ML
2.5MG
2.5MG
2.5MG
167MG/5ML;167MG/5ML;167MG/5ML
167MG/5ML;167MG/5ML;167MG/5ML
167MG/5ML;167MG/5ML;167MG/5ML
167MG/5ML;167MG/5ML;167MG/5ML
167MG/5ML;167MG/5ML;167MG/5ML
167MG/ML;167MG/ML;167MG/ML
167MG/5ML;167MG/5ML;167MG/5ML
167MG;167MG;167MG
167MG;167MG;167MG
167MG;167MG;167MG
167MG;167MG;167MG
167MG;167MG;167MG
167MG;167MG;167MG
167MG;167MG;167MG
167MG;167MG;167MG
200MG
300MG
400MG
200MG
300MG
400MG
6-315( of 322)
N005794 002
A088463 001 Jan 03, 1985
A088462 001 Jan 03, 1985
N011496 002 Jul 01, 1983
A087963 001 Jan 18, 1983
A085940 001
A088735 001 Jan 17, 1985
A087514 001 Feb 10, 1982
N011110 002 Jul 01, 1983
A085610 001
A085094 001
A080123 002
N006317 012
A080100 001
A080013 002
N006904 002
A080280 001
N006920 003
N006317 011
A080079 001
A080099 001
A080013 001
N006904 001
A080086 001
N006920 002
A080094 001
N020719 001 Jan 29, 1997
N020719 003 Aug 04, 1997
N020719 002 Jan 29, 1997
N020720 001 Jan 29, 1997
N020720 003 Aug 04, 1997
N020720 002 Jan 29, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
TROLAMINE POLYPEPTIDE OLEATE CONDENSATE
SOLUTION/DROPS;OTIC
CERUMENEX
PHARM RES ASSOC
TROLEANDOMYCIN
CAPSULE;ORAL
TAO
PFIZER
SUSPENSION;ORAL
TAO
PFIZER
TROPICAMIDE
SOLUTION/DROPS;OPHTHALMIC
MYDRIACYL
ALCON
MYDRIAFAIR
PHARMAFAIR
TROPICAMIDE
AKORN
ALCON PHARMS LTD
MIZA PHARMS USA
WATSON LABS
TROVAFLOXACIN MESYLATE
TABLET;ORAL
TROVAN
PFIZER
TUBOCURARINE CHLORIDE
INJECTABLE;INJECTION
TUBOCURARINE CHLORIDE
BRISTOL MYERS SQUIBB
HOSPIRA
LILLY
TYROPANOATE SODIUM
CAPSULE;ORAL
BILOPAQUE
GE HEALTHCARE
URACIL MUSTARD
CAPSULE;ORAL
URACIL MUSTARD
SHIRE
UREA
INJECTABLE;INJECTION
STERILE UREA
HOSPIRA
UREAPHIL
HOSPIRA
UREA C-13
FOR SOLUTION;ORAL
HELICOSOL
METABOLIC SOLUTIONS
MERETEK UBT KIT (W/ PRANACTIN)
OTSUKA AMERICA
PYLORI-CHEK BREATH TEST
DXS DEVICES
UROFOLLITROPIN
INJECTABLE;INTRAMUSCULAR
METRODIN
SERONO
INJECTABLE;SUBCUTANEOUS
FERTINEX
SERONO
10%
EQ 250MG BASE
EQ 125MG BASE/5ML
0.5%
1%
0.5%
1%
1%
1%
0.5%
1%
0.5%
EQ 100MG BASE
EQ 200MG BASE
3MG/ML
3MG/ML
3MG/ML
750MG
1MG
40GM/VIAL
40GM/VIAL
125MG/VIAL
125MG/VIAL
100MG/VIAL
75 IU/AMP
150 IU/AMP
75 IU/AMP
150 IU/AMP
6-316( of 322)
N011340 002
N050336 002
N050332 001
N012111 002
N012111 004
A088274 001 Sep 16, 1983
A088230 001 Sep 16, 1983
A088447 001 Aug 28, 1985
A089172 001 Dec 28, 1990
A087636 001 Jul 30, 1982
A087637 001 Aug 09, 1982
A089171 001 Dec 28, 1990
N020759 001 Dec 18, 1997
N020759 002 Dec 18, 1997
N005657 001
N006095 001
N006325 001
N013731 001
N012892 001
N017698 001
N012154 001
N021092 001 Dec 17, 1999
N020586 001 Sep 17, 1996
N020900 001 Feb 04, 1999
N019415 002 Sep 18, 1986
N019415 003 Sep 18, 1986
N019415 005 Aug 23, 1996
N019415 004 Aug 23, 1996
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-317( of 322)
UROKINASE
INJECTABLE;INJECTION
KINLYTIC
MICROBIX BIOSYSTEMS 5,000 IU/VIAL N021846 003
9,000 IU/VIAL N021846 002
250,000 IU/VIAL N021846 001
URSODIOL
CAPSULE;ORAL
ACTIGALL
WATSON PHARMS 150MG N019594 001 Dec 31, 1987
TABLET;ORAL
URSODIOL
TEVA PHARMS USA 250MG A079184 001 May 13, 2009
500MG A079184 002 May 13, 2009
VALDECOXIB
TABLET;ORAL
BEXTRA
GD SEARLE 10MG N021341 002 Nov 16, 2001
20MG N021341 003 Nov 16, 2001
VALPROIC ACID
CAPSULE;ORAL
VALPROIC ACID
PAR PHARM 250MG A070431 001 Feb 28, 1986
SCHERER RP 250MG A070195 001 Jul 02, 1987
USL PHARMA 250MG A070631 001 Jun 11, 1987
CAPSULE, DELAYED RELEASE;ORAL
STAVZOR
BANNER PHARMACAPS 125MG N022152 001 Jul 29, 2008
250MG N022152 002 Jul 29, 2008
500MG N022152 003 Jul 29, 2008
SYRUP;ORAL
VALPROIC ACID
APOTEX INC 250MG/5ML A077105 001 Jul 29, 2005
VALSARTAN
CAPSULE;ORAL
DIOVAN
NOVARTIS 80MG N020665 001 Dec 23, 1996
160MG N020665 002 Dec 23, 1996
VANCOMYCIN HYDROCHLORIDE
FOR SOLUTION;ORAL
VANCOCIN HYDROCHLORIDE
VIROPHARMA EQ 250MG BASE/5ML A061667 002 Jul 13, 1983
EQ 500MG BASE/6ML A061667 001
VANCOLED
LEDERLE EQ 250MG BASE/5ML A063321 002 Oct 15, 1993
EQ 500MG BASE/6ML A063321 003 Oct 15, 1993
INJECTABLE;INJECTION
VANCOCIN HYDROCHLORIDE
VIROPHARMA EQ 1GM BASE/VIAL A060180 002 Mar 21, 1986
EQ 1GM BASE/VIAL A062476 002 Mar 21, 1986
EQ 1GM BASE/VIAL A062716 002 Mar 13, 1987
EQ 1GM BASE/VIAL A062812 002 Nov 17, 1987
EQ 10GM BASE/VIAL A062812 003 Nov 17, 1987
EQ 500MG BASE/VIAL A060180 001
EQ 500MG BASE/VIAL A062476 001 Mar 15, 1984
EQ 500MG BASE/VIAL A062716 001 Mar 13, 1987
EQ 500MG BASE/VIAL A062812 001 Nov 17, 1987
VANCOLED
HIKMA MAPLE EQ 1GM BASE/VIAL A062682 002 Mar 30, 1988
EQ 2GM BASE/VIAL A062682 003 May 11, 1988
EQ 5GM BASE/VIAL A062682 004 May 11, 1988
EQ 10GM BASE/VIAL A062682 005 May 11, 1988
EQ 500MG BASE/VIAL A062682 001 Jul 22, 1986
VANCOMYCIN HYDROCHLORIDE
HIKMA MAPLE EQ 1GM BASE/VIAL A062879 002 Aug 02, 1988
EQ 500MG BASE/VIAL A062879 001 Aug 02, 1988
VANCOR
PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL A062956 002 Aug 01, 1988
EQ 500MG BASE/VIAL A062956 001 Aug 01, 1988
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-318( of 322)
VASOPRESSIN TANNATE
INJECTABLE;INJECTION
PITRESSIN TANNATE
PARKE DAVIS 5PRESSOR UNITS/ML N003402 001
VECURONIUM BROMIDE
INJECTABLE;INJECTION
NORCURON
ORGANON USA INC 10MG/VIAL N018776 002 Apr 30, 1984
20MG/VIAL N018776 003 Jan 03, 1992
VECURONIUM BROMIDE
HIKMA MAPLE 10MG/VIAL A075218 001 Aug 23, 1999
20MG/VIAL A075218 002 Aug 23, 1999
HOSPIRA 4MG/VIAL A075558 001 Sep 11, 2001
VELAGLUCERASE ALFA
POWDER;IV (INFUSION)
VPRIV
SHIRE HUMAN GENETIC 200 UNITS/VIAL N022575 002 Feb 26, 2010
VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
EFFEXOR XR
WYETH PHARMS INC EQ 100MG BASE N020699 003 Oct 20, 1997
TABLET;ORAL
EFFEXOR
WYETH PHARMS INC EQ 12.5MG BASE N020151 001 Dec 28, 1993
EQ 25MG BASE N020151 002 Dec 28, 1993
EQ 37.5MG BASE N020151 006 Dec 28, 1993
EQ 50MG BASE N020151 003 Dec 28, 1993
EQ 75MG BASE N020151 004 Dec 28, 1993
EQ 100MG BASE N020151 005 Dec 28, 1993
VENLAFAXINE HYDROCHLORIDE
PLIVA HRVATSKA DOO EQ 25MG BASE A078517 001 Jun 13, 2008
EQ 37.5MG BASE A078517 002 Jun 13, 2008
EQ 50MG BASE A078517 003 Jun 13, 2008
EQ 75MG BASE A078517 004 Jun 13, 2008
EQ 100MG BASE A078517 005 Jun 13, 2008
SANDOZ EQ 25MG BASE A077515 001 Jun 13, 2008
EQ 37.5MG BASE A077515 002 Jun 13, 2008
EQ 50MG BASE A077515 003 Jun 13, 2008
EQ 75MG BASE A077515 004 Jun 13, 2008
EQ 100MG BASE A077515 005 Jun 13, 2008
VERAPAMIL HYDROCHLORIDE
INJECTABLE;INJECTION
CALAN
GD SEARLE LLC 2.5MG/ML N018925 001 Mar 30, 1984
2.5MG/ML N019038 001 Mar 30, 1984
ISOPTIN
FSC 2.5MG/ML N018485 001
VERAPAMIL HYDROCHLORIDE
ABRAXIS PHARM 2.5MG/ML A070348 001 May 01, 1986
BEDFORD 2.5MG/ML A072888 001 Jul 28, 1995
HOSPIRA 2.5MG/ML A070577 001 Feb 02, 1987
2.5MG/ML A070739 001 May 06, 1987
2.5MG/ML A070740 001 May 06, 1987
INTL MEDICATION 2.5MG/ML A070451 001 Dec 16, 1985
LUITPOLD 2.5MG/ML A070225 001 Nov 12, 1985
2.5MG/ML A070617 001 Nov 12, 1985
MARSAM PHARMS LLC 2.5MG/ML A072233 001 Feb 26, 1993
2.5MG/ML A073485 001 Sep 27, 1993
SMITH AND NEPHEW 2.5MG/ML A070696 001 Jul 31, 1987
2.5MG/ML A070697 001 Jul 31, 1987
SOLOPAK 2.5MG/ML A070695 001 Jul 31, 1987
TABLET;ORAL
CALAN
GD SEARLE LLC 160MG N018817 004 Feb 23, 1988
ISOPTIN
FSC 40MG N018593 003 Nov 23, 1987
80MG N018593 001 Mar 08, 1982
120MG N018593 002 Mar 08, 1982
VERAPAMIL HYDROCHLORIDE
ACTAVIS ELIZABETH 80MG A071019 001 Sep 24, 1986
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-319( of 322)
VERAPAMIL HYDROCHLORIDE
TABLET;ORAL
VERAPAMIL HYDROCHLORIDE
120MG A070468 001 Sep 24, 1986
MUTUAL PHARM 80MG A070482 001 Sep 24, 1986
80MG A071489 002 Jan 13, 1988
120MG A070483 001 Sep 24, 1986
120MG A071489 001 Jan 13, 1988
PLIVA 40MG A072751 001 Feb 23, 1996
80MG A072124 001 Jan 26, 1989
120MG A072125 001 Jan 26, 1989
SANDOZ 40MG A073168 001 Jul 31, 1992
80MG A071423 001 May 24, 1988
120MG A071424 001 May 25, 1988
WARNER CHILCOTT 80MG A070340 001 Sep 24, 1986
120MG A070341 001 Sep 24, 1986
WATSON LABS 40MG A072799 001 Apr 28, 1989
TABLET, EXTENDED RELEASE;ORAL
VERAPAMIL HYDROCHLORIDE
PLIVA 240MG A072922 001 Mar 01, 1996
VERATRUM VIRIDE ROOT
TABLET;ORAL
VERTAVIS
MEDPOINTE PHARM HLC 130CSR UNIT N005691 002
VIDARABINE
INJECTABLE;INJECTION
VIRA-A
PARKEDALE EQ 187.4MG BASE/ML N050523 001
OINTMENT;OPHTHALMIC
VIRA-A
PARKEDALE 3% N050486 001
VINBLASTINE SULFATE
INJECTABLE;INJECTION
VELBAN
LILLY 10MG/VIAL N012665 001
VINBLASTINE SULFATE
ABRAXIS PHARM 10MG/VIAL A089011 001 Nov 18, 1985
HOSPIRA 10MG/VIAL A089565 001 Aug 18, 1987
VINCRISTINE SULFATE
INJECTABLE;INJECTION
ONCOVIN
LILLY 1MG/VIAL N014103 001
1MG/ML N014103 003 Mar 07, 1984
5MG/VIAL N014103 002
VINCASAR PFS
TEVA PARENTERAL 1MG/ML A071426 001 Jul 17, 1987
VINCREX
BRISTOL MYERS SQUIBB 5MG/VIAL A070867 001 Jul 12, 1988
VINCRISTINE SULFATE
ABIC 1MG/ML A070873 001 Feb 19, 1987
ABRAXIS PHARM 1MG/ML A070411 001 Sep 10, 1986
FRESENIUS KABI USA 1MG/ML A076296 001 Dec 20, 2002
1MG/ML A076401 001 Oct 28, 2003
HOSPIRA 1MG/VIAL A071559 001 Apr 11, 1988
2MG/VIAL A071560 001 Apr 11, 1988
5MG/VIAL A071561 001 Apr 11, 1988
VIOMYCIN SULFATE
INJECTABLE;INJECTION
VIOCIN SULFATE
PFIZER EQ 1GM BASE/VIAL A061086 001
EQ 5GM BASE/VIAL A061086 002
VITAMIN A
CAPSULE;ORAL
AQUASOL A
ASTRAZENECA 25,000USP UNITS A083080 002
50,000USP UNITS A083080 001
VITAMIN A
BANNER PHARMACAPS 50,000USP UNITS A083973 001
CHASE CHEM 50,000 IU A083351 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
VITAMIN A
CAPSULE;ORAL
VITAMIN A
EVERYLIFE 50,000 IU
IMPAX LABS 50,000USP UNITS
WEST WARD 50,000USP UNITS
VITAMIN A PALMITATE
CAPSULE;ORAL
AFAXIN
STERLING WINTHROP EQ 50,000 UNITS BASE
ALPHALIN
LILLY EQ 50,000 UNITS BASE
DEL-VI-A
DEL RAY LABS EQ 50,000 UNITS BASE
VI-DOM-A
BAYER PHARMS EQ 50,000 UNITS BASE
VITAMIN A
BANNER PHARMACAPS EQ 50,000 UNITS BASE
BRISTOL MYERS SQUIBB EQ 50,000 UNITS BASE
CHASE CHEM EQ 50,000 UNITS BASE
EQ 50,000 UNITS BASE
ELKINS SINN EQ 50,000 UNITS BASE
EVERYLIFE EQ 50,000 UNITS BASE
EQ 50,000 UNITS BASE
IMPAX LABS EQ 50,000 UNITS BASE
EQ 50,000 UNITS BASE
IVAX SUB TEVA PHARMS EQ 50,000 UNITS BASE
EQ 50,000 UNITS BASE
MK LABS EQ 25,000 UNITS BASE
EQ 50,000 UNITS BASE
WEST WARD EQ 50,000 UNITS BASE
WHARTON LABS EQ 50,000 UNITS BASE
VITAMIN A PALMITATE
ARCUM EQ 50,000 UNITS BASE
EQ 50,000 UNITS BASE
BANNER PHARMACAPS EQ 50,000 UNITS BASE
EQ 50,000 UNITS BASE
VITAMIN A SOLUBILIZED
TEVA EQ 50,000 UNITS BASE
INJECTABLE;INJECTION
VITAMIN A PALMITATE
BEL MAR EQ 50,000 UNITS BASE/ML
WARFARIN POTASSIUM
TABLET;ORAL
ATHROMBIN-K
PHARM RES ASSOC 2MG
5MG
10MG
25MG
WARFARIN SODIUM
INJECTABLE;INJECTION
COUMADIN
BRISTOL MYERS SQUIBB 50MG/VIAL
75MG/VIAL
TABLET;ORAL
ATHROMBIN
PHARM RES ASSOC 5MG
10MG
25MG
PANWARFIN
ABBOTT 2MG
2.5MG
5MG
7.5MG
10MG
WARFARIN SODIUM
SANDOZ 1MG
2MG
2.5MG
3MG
4MG
6-320( of 322)
A083134 001
A080952 001
A080985 001
A083187 001
A080883 001
A080830 001
A080972 001
A080702 001
A080860 001
A080746 001
A083207 001
A085479 001
A080943 001
A083114 001
A080953 001
A080955 001
A083035 001
A083190 001
A083457 002
A083457 001
A080967 001
A083665 001
A083311 001
A083321 001
A083948 001
A083981 001
A080921 001
A080819 001
N011771 007
N011771 004
N011771 005
N011771 006
N009218 020
N009218 012
N011771 003
N011771 002
N011771 001
N017020 001
N017020 002
N017020 003
N017020 004
N017020 005
A040196 001 Sep 30, 1997
A040196 002 Sep 30, 1997
A040196 003 Sep 30, 1997
A040196 008 Jul 26, 2000
A040196 004 Sep 30, 1997
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-321( of 322)
WARFARIN SODIUM
TABLET;ORAL
WARFARIN SODIUM
5MG A040196 005 Sep 30, 1997
6MG A040196 009 Jul 26, 2000
7.5MG A040196 006 Sep 30, 1997
10MG A040196 007 Sep 30, 1997
USL PHARMA 2MG A088719 001 Jun 27, 1985
2.5MG A088720 001 Aug 06, 1985
5MG A088721 001 Jul 02, 1985
WATSON LABS 2MG A086123 001 Aug 17, 1982
2.5MG A086120 001 Aug 17, 1982
5MG A086119 001 Aug 17, 1982
7.5MG A086118 001 Aug 17, 1982
10MG A086122 001 Aug 17, 1982
XENON XE-127
GAS;INHALATION
XENON XE 127
MALLINCKRODT 5mCi/VIAL N018536 001 Oct 01, 1982
10mCi/VIAL N018536 002 Oct 01, 1982
XENON XE-133
GAS;INHALATION
XENON XE 133
GE HEALTHCARE 1 CI/AMP N017256 002
10mCi/VIAL N017687 002
20mCi/VIAL N017687 003
GEN ELECTRIC 5-100 CI/CYLINDER N017550 001
0.25-5 CI/AMP N017550 003
MALLINCKRODT 10mCi/VIAL N018327 001 Mar 09, 1982
20mCi/VIAL N018327 002 Mar 09, 1982
XENON XE 133-V.S.S.
GE HEALTHCARE 10mCi/VIAL N017687 001
INJECTABLE;INJECTION
XENON XE 133
GE HEALTHCARE 1.3-1.7 CI/AMP N017256 001
LANTHEUS MEDCL 6.3mCi/ML N017283 001
SOLUTION;INHALATION, INJECTION
XENEISOL
MALLINCKRODT 18-25mCi/AMP N017262 002
XYLOSE
POWDER;ORAL
XYLO-PFAN
SAVAGE LABS 25GM/BOT N017605 001
XYLOSE
LYNE 25GM/BOT N018856 001 Mar 26, 1987
ZALCITABINE
TABLET;ORAL
HIVID
ROCHE 0.375MG N020199 001 Jun 19, 1992
0.75MG N020199 002 Jun 19, 1992
ZALEPLON
CAPSULE;ORAL
ZALEPLON
SANDOZ 5MG A078095 001 Jun 06, 2008
10MG A078095 002 Jun 06, 2008
ZICONOTIDE
INJECTABLE;INTRATHECAL
PRIALT
JAZZ PHARMS INTL 200MCG/2ML (100MCG/ML) N021060 003 Dec 28, 2004
ZIDOVUDINE
TABLET;ORAL
RETROVIR
VIIV HLTHCARE 200MG N020518 001 Dec 19, 1995
300MG **Federal Register determination N020518 002 Oct 04, 1996
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
ZIDOVUDINE
AUROBINDO PHARMA 60MG N022294 001 Jul 23, 2009
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-322( of 322)
ZIDOVUDINE
TABLET;ORAL
ZIDOVUDINE
MATRIX LABS LTD 100MG N200732 001 Feb 23, 2011
RANBAXY LABS LTD 300MG A077327 001 Sep 19, 2005
ZILEUTON
TABLET;ORAL
ZYFLO
CORNERSTONE THERAP 300MG N020471 001 Dec 09, 1996
ZINC SULFATE
INJECTABLE;INJECTION
ZINC SULFATE
ABRAXIS PHARM EQ 1MG ZINC/ML N019229 002 May 05, 1987
ZOLEDRONIC ACID
INJECTABLE;IV (INFUSION)
ZOMETA
NOVARTIS EQ 4MG BASE/VIAL **Federal Register N021223 001 Aug 20, 2001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ZOLPIDEM TARTRATE
TABLET;ORAL
ZOLPIDEM TARTRATE
DR REDDYS LABS LTD 5MG A077985 001 Apr 23, 2007
10MG A077985 002 Apr 23, 2007
MUTUAL PHARMA 5MG A077288 001 Apr 23, 2007
10MG A077288 002 Apr 23, 2007
MYLAN PHARMS INC 5MG A078016 001 Apr 23, 2007
10MG A078016 002 Apr 23, 2007
SYNTHON PHARMS 5MG A077540 001 Apr 23, 2007
10MG A077540 002 Apr 23, 2007
WORLD GEN 5MG A076062 001 Apr 23, 2007
10MG A076062 002 Apr 23, 2007
TABLET, ORALLY DISINTEGRATING;ORAL
TOVALT ODT
BIOVAIL LABS INTL 5MG N021412 001 Apr 25, 2007
10MG N021412 002 Apr 25, 2007
ZONISAMIDE
CAPSULE;ORAL
ZONISAMIDE
COREPHARMA 25MG A077876 001 Feb 21, 2007
50MG A077876 002 Feb 21, 2007
100MG A077876 003 Feb 21, 2007
DR REDDYS LABS LTD 25MG A077645 002 Sep 29, 2006
50MG A077645 003 Sep 29, 2006
100MG A077645 001 Dec 22, 2005
MUTUAL PHARM 25MG A077635 001 Dec 22, 2005
50MG A077635 002 Dec 22, 2005
100MG A077635 003 Dec 22, 2005
ROXANE 25MG A077648 001 Dec 22, 2005
50MG A077648 002 Dec 22, 2005
100MG A077648 003 Dec 22, 2005
TEVA PHARMS 25MG A077641 003 Dec 22, 2005
50MG A077641 002 Dec 22, 2005
100MG A077641 001 Dec 22, 2005
WATSON LABS 25MG A077650 001 Apr 20, 2006
50MG A077650 002 Apr 20, 2006
100MG A077650 003 Apr 20, 2006

7-1
34THEDITION-2014-APPROVEDDRUGPRODUCTSLIST
ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST
ThelistofListofOrphanDesignationsandApprovalsisavailableat:
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm
































8-1
34THEDITION-2014-APPROVEDDRUGPRODUCTSLIST
DRUGPRODUCTSWHICHMUSTDEMONSTRATEIN VIVO BIOAVAILABILITY
ONLYIFPRODUCTFAILSTOACHIEVEADEQUATEDISSOLUTION
ACETAMI NOPHEN; ASPI RI N; BUTALBI TAL
CAPSULE OR TABLET; ORAL
160- 165MG; 160- 165MG; 50MG
325MG; 325MG; 50MG
ACETAMI NOPHEN; ASPI RI N; BUTALBI TAL;
CAFFEI NE
CAPSULE OR TABLET; ORAL
160- 165MG; 160- 165MG; 50MG; 40MG
325MG; 325MG; 50MG; 40MG
ACETAMI NOPHEN; BUTALBI TAL
CAPSULE OR TABLET; ORAL
325MG; 50MG
ACETAMI NOPHEN; BUTALBI TAL; CAFFEI NE
CAPSULE OR TABLET; ORAL
325MG; 50MG; 40MG
AMI NOPHYLLI NE
TABLET; ORAL
100MG; 200MG
ASPI RI N; BUTALBI TAL
CAPSULE OR TABLET; ORAL
325MG; 50MG
650MG; 50MG
ASPI RI N; BUTALBI TAL; CAFFEI NE
CAPSULE OR TABLET; ORAL
325MG; 50MG; 40MG
650MG; 50MG; 40MG
ASPI RI N; CAFFEI NE; CARI SOPRODOL
TABLET; ORAL
160MG; 32MG; 200MG
ASPI RI N; CAFFEI NE; CARI SOPRODOL;
CODEI NE PHOSPHATE
TABLET; ORAL
160MG; 32MG; 200MG; 16MG
ASPI RI N; CARI SOPRODOL
TABLET; ORAL
325MG; 200MG
ASPI RI N; CARI SOPRODOL;
CODEI NE PHOSPHATE
TABLET; ORAL
325MG; 200MG; 16MG
ASPI RI N; MEPROBAMATE
TABLET; ORAL
325MG; 200MG
ASPI RI N; METHOCARBAMOL
TABLET; ORAL
325MG; 400MG
CHLOROTHI AZI DE
TABLET; ORAL
250MG
HYDROXYZI NE HYDROCHLORI DE
TABLET; ORAL
10MG; 25MG;
50MG; 100MG
PREDNI SONE
TABLET; ORAL
1MG; 2. 5MG; 5MG; 10MG;
20MG; 25MG; 50MG




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 1
APPENDI X A - PRODUCT NAME I NDEX
* * 8 * *
8- MOP, METHOXSALEN
* * A * *
A- HYDROCORT, HYDROCORTI SONE SODI UM SUCCI NATE
A- METHAPRED, METHYLPREDNI SOLONE SODI UM SUCCI NATE
ABACAVI R SULFATE, ABACAVI R SULFATE
ABACAVI R SULFATE, LAMI VUDI NE AND ZI DOVUDI NE, ABACAVI R SULFATE
ABELCET, AMPHOTERI CI N B
ABI LI FY, ARI PI PRAZOLE
ABI LI FY MAI NTENA KI T, ARI PI PRAZOLE
ABLAVAR, GADOFOSVESET TRI SODI UM
ABRAXANE, PACLI TAXEL
ABREVA, DOCOSANOL ( OTC)
ABSORI CA, I SOTRETI NOI N
ABSTRAL, FENTANYL CI TRATE
ACAMPROSATE CALCI UM, ACAMPROSATE CALCI UM
ACANYA, BENZOYL PEROXI DE
ACARBOSE, ACARBOSE
ACARBOSE , ACARBOSE
ACCOLATE, ZAFI RLUKAST
ACCUNEB, ALBUTEROL SULFATE
ACCUPRI L, QUI NAPRI L HYDROCHLORI DE
ACCURETI C, HYDROCHLOROTHI AZI DE
ACEBUTOLOL HYDROCHLORI DE, ACEBUTOLOL HYDROCHLORI DE
ACEON, PERI NDOPRI L ERBUMI NE
ACEPHEN, ACETAMI NOPHEN ( OTC)
ACETADOTE, ACETYLCYSTEI NE
ACETAMI NOPHEN, ACETAMI NOPHEN ( OTC)
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
ACETAMI NOPHEN AND PENTAZOCI NE HYDROCHLORI DE, ACETAMI NOPHEN
ACETAMI NOPHEN, ASPI RI N AND CAFFEI NE, ACETAMI NOPHEN ( OTC)
ACETASOL HC, ACETI C ACI D, GLACI AL
ACETAZOLAMI DE, ACETAZOLAMI DE
ACETAZOLAMI DE SODI UM, ACETAZOLAMI DE SODI UM
ACETI C ACI D, ACETI C ACI D, GLACI AL
ACETI C ACI D 0. 25%I N PLASTI C CONTAI NER, ACETI C ACI D, GLACI AL
ACETI C ACI D 2%I N AQUEOUS ALUMI NUM ACETATE, ACETI C ACI D, GLACI AL
ACETOHEXAMI DE, ACETOHEXAMI DE
ACETYLCYSTEI NE, ACETYLCYSTEI NE
ACHROMYCI N V, TETRACYCLI NE HYDROCHLORI DE
ACI PHEX, RABEPRAZOLE SODI UM
ACI PHEX SPRI NKLE, RABEPRAZOLE SODI UM
ACI TRETI N, ACI TRETI N
ACLOVATE, ALCLOMETASONE DI PROPI ONATE
ACOVA, ARGATROBAN
ACTHREL, CORTI CORELI N OVI NE TRI FLUTATE
ACTI GALL, URSODI OL
ACTI Q, FENTANYL CI TRATE
ACTI VELLA, ESTRADI OL
ACTONEL, RI SEDRONATE SODI UM
ACTOPLUS MET, METFORMI N HYDROCHLORI DE
ACTOPLUS MET XR, METFORMI N HYDROCHLORI DE
ACTOS, PI OGLI TAZONE HYDROCHLORI DE
ACULAR, KETOROLAC TROMETHAMI NE
ACULAR LS, KETOROLAC TROMETHAMI NE
ACUVAI L, KETOROLAC TROMETHAMI NE
ACYCLOVI R, ACYCLOVI R
ACYCLOVI R I N SODI UM CHLORI DE 0. 9%PRESERVATI VE FREE, ACYCLOVI R SODI UM
ACYCLOVI R SODI UM, ACYCLOVI R SODI UM
ACZONE, DAPSONE
ADAGEN, PEGADEMASE BOVI NE
ADALAT CC, NI FEDI PI NE
ADAPALENE, ADAPALENE
ADASUVE, LOXAPI NE
ADCI RCA, TADALAFI L














34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 2
APPENDI X A - PRODUCT NAME I NDEX
* * A * *
ADDERALL XR 10, AMPHETAMI NE ASPARTATE
ADDERALL XR 15, AMPHETAMI NE ASPARTATE
ADDERALL XR 20, AMPHETAMI NE ASPARTATE
ADDERALL XR 25, AMPHETAMI NE ASPARTATE
ADDERALL XR 30, AMPHETAMI NE ASPARTATE
ADDERALL XR 5, AMPHETAMI NE ASPARTATE
ADEFOVI R DI PI VOXI L, ADEFOVI R DI PI VOXI L
ADEMPAS, RI OCI GUAT
ADENOCARD, ADENOSI NE
ADENOSCAN, ADENOSI NE
ADENOSI NE, ADENOSI NE
ADI PEX- P, PHENTERMI NE HYDROCHLORI DE
ADRENACLI CK, EPI NEPHRI NE
ADRENALI N, EPI NEPHRI NE
ADREVI EW, I OBENGUANE SULFATE I - 123
ADVAI R DI SKUS 100/ 50, FLUTI CASONE PROPI ONATE
ADVAI R DI SKUS 250/ 50, FLUTI CASONE PROPI ONATE
ADVAI R DI SKUS 500/ 50, FLUTI CASONE PROPI ONATE
ADVAI R HFA, FLUTI CASONE PROPI ONATE
ADVI COR, LOVASTATI N
ADVI L, I BUPROFEN ( OTC)
ADVI L, I BUPROFEN SODI UM ( OTC)
ADVI L ALLERGY AND CONGESTI ON RELI EF, CHLORPHENI RAMI NE MALEATE ( OTC)
ADVI L ALLERGY SI NUS, CHLORPHENI RAMI NE MALEATE ( OTC)
ADVI L COLD AND SI NUS, I BUPROFEN ( OTC)
ADVI L CONGESTI ON RELI EF, I BUPROFEN ( OTC)
ADVI L LI QUI - GELS, I BUPROFEN ( OTC)
ADVI L MI GRAI NE LI QUI - GELS, I BUPROFEN ( OTC)
ADVI L PM, DI PHENHYDRAMI NE CI TRATE ( OTC)
ADVI L PM, DI PHENHYDRAMI NE HYDROCHLORI DE ( OTC)
AEROSPAN HFA, FLUNI SOLI DE
AFEDI TAB CR, NI FEDI PI NE
AFI NI TOR, EVEROLI MUS
AFI NI TOR DI SPERZ, EVEROLI MUS
AFRI NOL, PSEUDOEPHEDRI NE SULFATE ( OTC)
AGGRASTAT, TI ROFI BAN HYDROCHLORI DE
AGGRENOX, ASPI RI N
AGRYLI N, ANAGRELI DE HYDROCHLORI DE
AK- FLUOR 10%, FLUORESCEI N SODI UM
AK- FLUOR 25%, FLUORESCEI N SODI UM
AKBETA, LEVOBUNOLOL HYDROCHLORI DE
AKI NETON, BI PERI DEN HYDROCHLORI DE
AKNE- MYCI N, ERYTHROMYCI N
AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORI DE
AKPRO, DI PI VEFRI N HYDROCHLORI DE
AKTEN, LI DOCAI NE HYDROCHLORI DE
AKTOB, TOBRAMYCI N
ALA- CORT, HYDROCORTI SONE
ALA- SCALP, HYDROCORTI SONE
ALAMAST, PEMI ROLAST POTASSI UM
ALAVERT, LORATADI NE ( OTC)
ALAWAY, KETOTI FEN FUMARATE ( OTC)
ALBALON, NAPHAZOLI NE HYDROCHLORI DE
ALBENZA, ALBENDAZOLE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALBUTEROL SULFATE AND I PRATROPI UM BROMI DE, ALBUTEROL SULFATE
ALCAI NE, PROPARACAI NE HYDROCHLORI DE
ALCLOMETASONE DI PROPI ONATE, ALCLOMETASONE DI PROPI ONATE
ALCOHOL 10%AND DEXTROSE 5%, ALCOHOL
ALCOHOL 5%AND DEXTROSE 5%, ALCOHOL
ALDACTAZI DE, HYDROCHLOROTHI AZI DE
ALDACTONE, SPI RONOLACTONE
ALDARA, I MI QUI MOD
ALENDRONATE SODI UM, ALENDRONATE SODI UM
ALEVE, NAPROXEN SODI UM ( OTC)






34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 3
APPENDI X A - PRODUCT NAME I NDEX
* * A * *
ALEVE- D SI NUS & COLD, NAPROXEN SODI UM ( OTC)
ALFENTA, ALFENTANI L HYDROCHLORI DE
ALFENTANI L, ALFENTANI L HYDROCHLORI DE
ALFUZOSI N HYDROCHLORI DE, ALFUZOSI N HYDROCHLORI DE
ALI MTA, PEMETREXED DI SODI UM
ALI NI A, NI TAZOXANI DE
ALKERAN, MELPHALAN
ALKERAN, MELPHALAN HYDROCHLORI DE
ALLEGRA, FEXOFENADI NE HYDROCHLORI DE
ALLEGRA ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
ALLEGRA HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
ALLEGRA- D 12 HOUR ALLERGY AND CONGESTI ON, FEXOFENADI NE HYDROCHLORI DE ( OTC)
ALLEGRA- D 24 HOUR ALLERGY AND CONGESTI ON, FEXOFENADI NE HYDROCHLORI DE ( OTC)
ALLI , ORLI STAT ( OTC)
ALLOPURI NOL, ALLOPURI NOL
ALLOPURI NOL SODI UM, ALLOPURI NOL SODI UM
ALOCRI L, NEDOCROMI L SODI UM
ALOMI DE, LODOXAMI DE TROMETHAMI NE
ALOPRI M, ALLOPURI NOL SODI UM
ALORA, ESTRADI OL
ALOXI , PALONOSETRON HYDROCHLORI DE
ALPHAGAN P, BRI MONI DI NE TARTRATE
ALPRAZOLAM, ALPRAZOLAM
ALPROSTADI L, ALPROSTADI L
ALREX, LOTEPREDNOL ETABONATE
ALSUMA, SUMATRI PTAN SUCCI NATE
ALTABAX, RETAPAMULI N
ALTACE, RAMI PRI L
ALTAVERA, ETHI NYL ESTRADI OL
ALTOPREV, LOVASTATI N
ALVESCO, CI CLESONI DE
ALYACEN 1/ 35, ETHI NYL ESTRADI OL
ALYACEN 7/ 7/ 7, ETHI NYL ESTRADI OL
AMANTADI NE HYDROCHLORI DE, AMANTADI NE HYDROCHLORI DE
AMARYL, GLI MEPI RI DE
AMBI EN, ZOLPI DEM TARTRATE
AMBI EN CR, ZOLPI DEM TARTRATE
AMBI SOME, AMPHOTERI CI N B
AMCI NONI DE, AMCI NONI DE
AMERGE, NARATRI PTAN HYDROCHLORI DE
AMI CAR, AMI NOCAPROI C ACI D
AMI DATE, ETOMI DATE
AMI FOSTI NE, AMI FOSTI NE
AMI KACI N SULFATE, AMI KACI N SULFATE
AMI LORI DE HYDROCHLORI DE, AMI LORI DE HYDROCHLORI DE
AMI LORI DE HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, AMI LORI DE HYDROCHLORI DE
AMI NO ACI DS, AMI NO ACI DS
AMI NOACETI C ACI D 1. 5%I N PLASTI C CONTAI NER, GLYCI NE
AMI NOCAPROI C, AMI NOCAPROI C ACI D
AMI NOCAPROI C ACI D, AMI NOCAPROI C ACI D
AMI NOCAPROI C ACI D I N PLASTI C CONTAI NER, AMI NOCAPROI C ACI D
AMI NOHI PPURATE SODI UM, AMI NOHI PPURATE SODI UM
AMI NOPHYLLI NE, AMI NOPHYLLI NE
AMI NOSYN 10%, AMI NO ACI DS
AMI NOSYN 10%( PH6) , AMI NO ACI DS
AMI NOSYN 3. 5%, AMI NO ACI DS
AMI NOSYN 3. 5%M, AMI NO ACI DS
AMI NOSYN 5%, AMI NO ACI DS
AMI NOSYN 7%, AMI NO ACI DS
AMI NOSYN 7%( PH6) , AMI NO ACI DS
AMI NOSYN 7%W/ ELECTROLYTES, AMI NO ACI DS
AMI NOSYN 8. 5%, AMI NO ACI DS
AMI NOSYN 8. 5%( PH6) , AMI NO ACI DS
AMI NOSYN 8. 5%W/ ELECTROLYTES, AMI NO ACI DS
AMI NOSYN I I 10%, AMI NO ACI DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 4
APPENDI X A - PRODUCT NAME I NDEX
* * A * *
AMI NOSYN I I 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
AMI NOSYN I I 10%W/ ELECTROLYTES, AMI NO ACI DS
AMI NOSYN I I 15%I N PLASTI C CONTAI NER, AMI NO ACI DS
AMI NOSYN I I 7%, AMI NO ACI DS
AMI NOSYN I I 8. 5%, AMI NO ACI DS
AMI NOSYN I I 8. 5%W/ ELECTROLYTES, AMI NO ACI DS
AMI NOSYN- HBC 7%, AMI NO ACI DS
AMI NOSYN- HF 8%, AMI NO ACI DS
AMI NOSYN- PF 10%, AMI NO ACI DS
AMI NOSYN- PF 7%, AMI NO ACI DS
AMI NOSYN- RF 5. 2%, AMI NO ACI DS
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
AMI TI ZA, LUBI PROSTONE
AMI TRI PTYLI NE HYDROCHLORI DE, AMI TRI PTYLI NE HYDROCHLORI DE
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
AMLODI PI NE BESYLATE AND ATORVASTATI N CALCI UM, AMLODI PI NE BESYLATE
AMLODI PI NE BESYLATE AND BENAZEPRI L HYDROCHLORI DE, AMLODI PI NE BESYLATE
AMLODI PI NE BESYLATE AND VALSARTAN, AMLODI PI NE BESYLATE
AMLODI PI NE, VALSARTAN AND HYDROCHLOROTHI AZI DE, AMLODI PI NE
AMMONI A N 13, AMMONI A N- 13
AMMONI UM CHLORI DE I N PLASTI C CONTAI NER, AMMONI UM CHLORI DE
AMMONI UM LACTATE, AMMONI UM LACTATE
AMMONUL, SODI UM BENZOATE
AMNESTEEM, I SOTRETI NOI N
AMOXAPI NE, AMOXAPI NE
AMOXI CI LLI N, AMOXI CI LLI N
AMOXI CI LLI N AND CLAVULANATE POTASSI UM, AMOXI CI LLI N
AMOXI CI LLI N PEDI ATRI C, AMOXI CI LLI N
AMOXI L, AMOXI CI LLI N
AMPHADASE, HYALURONI DASE
AMPHETAMI NE ASP AMPHETAMI NE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF, AMPHETAMI NE
AMPHETAMI NE SULFATE, AMPHETAMI NE SULFATE
AMPHOTEC, AMPHOTERI CI N B
AMPHOTERI CI N B, AMPHOTERI CI N B
AMPI CI LLI N AND SULBACTAM, AMPI CI LLI N SODI UM
AMPI CI LLI N SODI UM, AMPI CI LLI N SODI UM
AMPI CI LLI N TRI HYDRATE, AMPI CI LLI N/ AMPI CI LLI N TRI HYDRATE
AMPYRA, DALFAMPRI DI NE
AMRI NONE LACTATE, I NAMRI NONE LACTATE
AMRI X, CYCLOBENZAPRI NE HYDROCHLORI DE
AMTURNI DE, ALI SKI REN HEMI FUMARATE
AMYVI D, FLORBETAPI R F- 18
AN- DTPA, TECHNETI UM TC- 99M PENTETATE KI T
AN- SULFUR COLLOI D, TECHNETI UM TC- 99M SULFUR COLLOI D KI T
ANADROL- 50, OXYMETHOLONE
ANAFRANI L, CLOMI PRAMI NE HYDROCHLORI DE
ANAGRELI DE HYDROCHLORI DE, ANAGRELI DE HYDROCHLORI DE
ANAPROX, NAPROXEN SODI UM
ANAPROX DS, NAPROXEN SODI UM
ANASTROZOLE, ANASTROZOLE
ANCEF I N PLASTI C CONTAI NER, CEFAZOLI N SODI UM
ANCOBON, FLUCYTOSI NE
ANDRODERM, TESTOSTERONE
ANDROGEL, TESTOSTERONE
ANDROI D 10, METHYLTESTOSTERONE
ANDROI D 25, METHYLTESTOSTERONE
ANECTI NE, SUCCI NYLCHOLI NE CHLORI DE
ANEXSI A, ACETAMI NOPHEN
ANEXSI A 5/ 325, ACETAMI NOPHEN
ANEXSI A 7. 5/ 325, ACETAMI NOPHEN
ANEXSI A 7. 5/ 650, ACETAMI NOPHEN
ANGELI Q, DROSPI RENONE
ANGI OMAX, BI VALI RUDI N
ANORO ELLI PTA, UMECLI DI NI UM BROMI DE
ANSAI D, FLURBI PROFEN




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 5
APPENDI X A - PRODUCT NAME I NDEX
* * A * *
ANTABUSE, DI SULFI RAM
ANTARA ( MI CRONI ZED) , FENOFI BRATE
ANTHELI OS 20, AVOBENZONE ( OTC)
ANTHELI OS 40, AVOBENZONE ( OTC)
ANTHELI OS SX, AVOBENZONE ( OTC)
ANTI VERT, MECLI ZI NE HYDROCHLORI DE
ANTI ZOL, FOMEPI ZOLE
ANUSOL HC, HYDROCORTI SONE
ANZEMET, DOLASETRON MESYLATE
API DRA, I NSULI N GLULI SI NE RECOMBI NANT
API DRA SOLOSTAR, I NSULI N GLULI SI NE RECOMBI NANT
APLENZI N, BUPROPI ON HYDROBROMI DE
APOKYN, APOMORPHI NE HYDROCHLORI DE
APRACLONI DI NE HYDROCHLORI DE, APRACLONI DI NE HYDROCHLORI DE
APREPI TANT, APREPI TANT
APRI SO, MESALAMI NE
APTI OM, ESLI CARBAZEPI NE ACETATE
APTI VUS, TI PRANAVI R
AQUASOL A, VI TAMI N A PALMI TATE
ARALEN, CHLOROQUI NE PHOSPHATE
ARANELLE, ETHI NYL ESTRADI OL
ARAVA, LEFLUNOMI DE
ARCAPTA NEOHALER, I NDACATEROL MALEATE
ARESTI N, MI NOCYCLI NE HYDROCHLORI DE
ARGATROBAN, ARGATROBAN
ARGATROBAN I N SODI UM CHLORI DE, ARGATROBAN
ARI CEPT, DONEPEZI L HYDROCHLORI DE
ARI CEPT ODT, DONEPEZI L HYDROCHLORI DE
ARI DOL KI T, MANNI TOL
ARI MI DEX, ANASTROZOLE
ARI STOSPAN, TRI AMCI NOLONE HEXACETONI DE
ARI XTRA, FONDAPARI NUX SODI UM
ARMODAFI NI L, ARMODAFI NI L
AROMASI N, EXEMESTANE
ARRANON, NELARABI NE
ARTHROTEC, DI CLOFENAC SODI UM
ARTI CAI NE HYDROCHLORI DE AND EPI NEPHRI NE BI TARTRATE, ARTI CAI NE HYDROCHLORI DE
ASACOL, MESALAMI NE
ASACOL HD, MESALAMI NE
ASCLERA, POLI DOCANOL
ASMANEX TWI STHALER, MOMETASONE FUROATE
ASPI RI N, ASPI RI N ( OTC)
ASPI RI N AND DI PYRI DAMOLE, ASPI RI N
ASTAGRAF XL, TACROLI MUS
ASTELI N, AZELASTI NE HYDROCHLORI DE
ASTEPRO, AZELASTI NE HYDROCHLORI DE
ASTRAMORPH PF, MORPHI NE SULFATE
ATACAND, CANDESARTAN CI LEXETI L
ATACAND HCT, CANDESARTAN CI LEXETI L
ATELVI A, RI SEDRONATE SODI UM
ATENOLOL, ATENOLOL
ATENOLOL AND CHLORTHALI DONE, ATENOLOL
ATI VAN, LORAZEPAM
ATORVASTATI N CALCI UM, ATORVASTATI N CALCI UM
ATOVAQUONE AND PROGUANI L HYDROCHLORI DE, ATOVAQUONE
ATRACURI UM BESYLATE, ATRACURI UM BESYLATE
ATRACURI UM BESYLATE PRESERVATI VE FREE, ATRACURI UM BESYLATE
ATRALI N, TRETI NOI N
ATRI DOX, DOXYCYCLI NE HYCLATE
ATRI PLA, EFAVI RENZ
ATROPEN, ATROPI NE
ATROPI NE SULFATE ANSYR PLASTI C SYRI NGE, ATROPI NE SULFATE
ATROVENT, I PRATROPI UM BROMI DE
ATROVENT HFA, I PRATROPI UM BROMI DE
AUBAGI O, TERI FLUNOMI DE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 6
APPENDI X A - PRODUCT NAME I NDEX
* * A * *
AUGMENTI N ' 125' , AMOXI CI LLI N
AUGMENTI N ' 200' , AMOXI CI LLI N
AUGMENTI N ' 250' , AMOXI CI LLI N
AUGMENTI N ' 400' , AMOXI CI LLI N
AUGMENTI N ' 500' , AMOXI CI LLI N
AUGMENTI N ' 875' , AMOXI CI LLI N
AUGMENTI N ES- 600, AMOXI CI LLI N
AUGMENTI N XR, AMOXI CI LLI N
AUVI - Q, EPI NEPHRI NE
AVAGARD, ALCOHOL ( OTC)
AVAGE, TAZAROTENE
AVALI DE, HYDROCHLOROTHI AZI DE
AVANDAMET, METFORMI N HYDROCHLORI DE
AVANDARYL, GLI MEPI RI DE
AVANDI A, ROSI GLI TAZONE MALEATE
AVAPRO, I RBESARTAN
AVC, SULFANI LAMI DE
AVELOX, MOXI FLOXACI N HYDROCHLORI DE
AVELOX I N SODI UM CHLORI DE 0. 8%I N PLASTI C CONTAI NER, MOXI FLOXACI N HYDROCHLORI DE
AVENTYL HYDROCHLORI DE, NORTRI PTYLI NE HYDROCHLORI DE
AVI ANE- 28, ETHI NYL ESTRADI OL
AVI NZA, MORPHI NE SULFATE
AVI TA, TRETI NOI N
AVODART, DUTASTERI DE
AXERT, ALMOTRI PTAN MALATE
AXI D, NI ZATI DI NE
AXI D AR, NI ZATI DI NE ( OTC)
AXI RON, TESTOSTERONE
AYGESTI N, NORETHI NDRONE ACETATE
AZACI TI DI NE, AZACI TI DI NE
AZACTAM, AZTREONAM
AZACTAM I N PLASTI C CONTAI NER, AZTREONAM
AZASAN, AZATHI OPRI NE
AZASI TE, AZI THROMYCI N
AZATHI OPRI NE, AZATHI OPRI NE
AZATHI OPRI NE SODI UM, AZATHI OPRI NE SODI UM
AZELASTI NE HYDROCHLORI DE, AZELASTI NE HYDROCHLORI DE
AZELEX, AZELAI C ACI D
AZI LECT, RASAGI LI NE MESYLATE
AZI THROMYCI N, AZI THROMYCI N
AZOPT, BRI NZOLAMI DE
AZOR, AMLODI PI NE BESYLATE
AZTREONAM, AZTREONAM
AZULFI DI NE, SULFASALAZI NE
AZULFI DI NE EN- TABS, SULFASALAZI NE
* * B * *
BACI I M, BACI TRACI N
BACI TRACI N, BACI TRACI N
BACI TRACI N ZI NC AND POLYMYXI N B SULFATE, BACI TRACI N ZI NC
BACI TRACI N- NEOMYCI N- POLYMYXI N W/ HYDROCORTI SONE ACETATE, BACI TRACI N
BACLOFEN, BACLOFEN
BACTERI OSTATI C SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
BACTERI OSTATI C WATER FOR I NJ ECTI ON I N PLASTI C CONTAI NER, STERI LE WATER FOR I NJ ECTI ON
BACTOCI LL I N PLASTI C CONTAI NER, OXACI LLI N SODI UM
BACTRI M, SULFAMETHOXAZOLE
BACTRI M DS, SULFAMETHOXAZOLE
BACTROBAN, MUPI ROCI N
BACTROBAN, MUPI ROCI N CALCI UM
BAL, DI MERCAPROL
BALANCED SALT, CALCI UM CHLORI DE
BALSALAZI DE DI SODI UM, BALSALAZI DE DI SODI UM
BALZI VA- 28, ETHI NYL ESTRADI OL
BANZEL, RUFI NAMI DE
BARACLUDE, ENTECAVI R


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 7
APPENDI X A - PRODUCT NAME I NDEX
* * B * *
BECONASE AQ, BECLOMETHASONE DI PROPI ONATE MONOHYDRATE
BELVI Q, LORCASERI N HYDROCHLORI DE
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
BENAZEPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, BENAZEPRI L HYDROCHLORI DE
BENI CAR, OLMESARTAN MEDOXOMI L
BENI CAR HCT, HYDROCHLOROTHI AZI DE
BENTYL, DI CYCLOMI NE HYDROCHLORI DE
BENTYL PRESERVATI VE FREE, DI CYCLOMI NE HYDROCHLORI DE
BENZACLI N, BENZOYL PEROXI DE
BENZAMYCI N, BENZOYL PEROXI DE
BENZAMYCI N PAK, BENZOYL PEROXI DE
BENZONATATE, BENZONATATE
BENZPHETAMI NE HYDROCHLORI DE, BENZPHETAMI NE HYDROCHLORI DE
BENZTROPI NE MESYLATE, BENZTROPI NE MESYLATE
BEPREVE, BEPOTASTI NE BESI LATE
BESI VANCE, BESI FLOXACI N HYDROCHLORI DE
BETA- VAL, BETAMETHASONE VALERATE
BETADI NE, POVI DONE- I ODI NE
BETAGAN, LEVOBUNOLOL HYDROCHLORI DE
BETAMETHASONE ACETATE AND BETAMETHASONE SODI UM PHOSPHATE, BETAMETHASONE ACETATE
BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
BETAPACE, SOTALOL HYDROCHLORI DE
BETAPACE AF, SOTALOL HYDROCHLORI DE
BETAXOLOL HYDROCHLORI DE, BETAXOLOL HYDROCHLORI DE
BETHANECHOL CHLORI DE, BETHANECHOL CHLORI DE
BETHKI S, TOBRAMYCI N
BETI MOL, TI MOLOL
BETOPTI C, BETAXOLOL HYDROCHLORI DE
BETOPTI C S, BETAXOLOL HYDROCHLORI DE
BEYAZ, DROSPI RENONE
BI AXI N, CLARI THROMYCI N
BI AXI N XL, CLARI THROMYCI N
BI CALUTAMI DE, BI CALUTAMI DE
BI CI LLI N C- R, PENI CI LLI N G BENZATHI NE
BI CI LLI N C- R 900/ 300, PENI CI LLI N G BENZATHI NE
BI CI LLI N L- A, PENI CI LLI N G BENZATHI NE
BI CNU, CARMUSTI NE
BI DI L, HYDRALAZI NE HYDROCHLORI DE
BI LTRI CI DE, PRAZI QUANTEL
BI NOSTO, ALENDRONATE SODI UM
BI OSCRUB, CHLORHEXI DI NE GLUCONATE ( OTC)
BI SOPROLOL FUMARATE, BI SOPROLOL FUMARATE
BI SOPROLOL FUMARATE AND HYDROCHLOROTHI AZI DE, BI SOPROLOL FUMARATE
BLEOMYCI N SULFATE, BLEOMYCI N SULFATE
BLEPH- 10, SULFACETAMI DE SODI UM
BLEPHAMI DE, PREDNI SOLONE ACETATE
BLEPHAMI DE S. O. P. , PREDNI SOLONE ACETATE
BLOXI VERZ, NEOSTI GMI NE METHYLSULFATE
BONI VA, I BANDRONATE SODI UM
BONTRI L, PHENDI METRAZI NE TARTRATE
BONTRI L PDM, PHENDI METRAZI NE TARTRATE
BOSULI F, BOSUTI NI B MONOHYDRATE
BRANCHAMI N 4%I N PLASTI C CONTAI NER, AMI NO ACI DS
BRAVELLE, UROFOLLI TROPI N
BREATHTEK UBT FOR H- PYLORI , UREA C- 13
BREO ELLI PTA, FLUTI CASONE FUROATE
BRETYLI UM TOSYLATE I N DEXTROSE 5%I N PLASTI C CONTAI NER, BRETYLI UM TOSYLATE
BREVI BLOC, ESMOLOL HYDROCHLORI DE
BREVI BLOC DOUBLE STRENGTH I N PLASTI C CONTAI NER, ESMOLOL HYDROCHLORI DE
BREVI BLOC I N PLASTI C CONTAI NER, ESMOLOL HYDROCHLORI DE
BREVI CON 28- DAY, ETHI NYL ESTRADI OL
BREVI TAL SODI UM, METHOHEXI TAL SODI UM
BRI AN CARE, CHLORHEXI DI NE GLUCONATE ( OTC)
BRI ELLYN, ETHI NYL ESTRADI OL


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 8
APPENDI X A - PRODUCT NAME I NDEX
* * B * *
BRI LI NTA, TI CAGRELOR
BRI MONI DI NE TARTRATE, BRI MONI DI NE TARTRATE
BRI NTELLI X, VORTI OXETI NE HYDROBROMI DE
BRI SDELLE, PAROXETI NE MESYLATE
BROMDAY, BROMFENAC SODI UM
BROMFED- DM, BROMPHENI RAMI NE MALEATE
BROMFENAC SODI UM, BROMFENAC SODI UM
BROMOCRI PTI NE MESYLATE, BROMOCRI PTI NE MESYLATE
BRONCHO SALI NE, SODI UM CHLORI DE ( OTC)
BROVANA, ARFORMOTEROL TARTRATE
BSS, CALCI UM CHLORI DE
BSS PLUS, CALCI UM CHLORI DE
BUDESONI DE, BUDESONI DE
BUMETANI DE, BUMETANI DE
BUPHENYL, SODI UM PHENYLBUTYRATE
BUPI VACAI NE HYDROCHLORI DE, BUPI VACAI NE HYDROCHLORI DE
BUPI VACAI NE HYDROCHLORI DE AND EPI NEPHRI NE, BUPI VACAI NE HYDROCHLORI DE
BUPI VACAI NE HYDROCHLORI DE PRESERVATI VE FREE, BUPI VACAI NE HYDROCHLORI DE
BUPI VACAI NE HYDROCHLORI DE W/ EPI NEPHRI NE, BUPI VACAI NE HYDROCHLORI DE
BUPRENEX, BUPRENORPHI NE HYDROCHLORI DE
BUPRENORPHI NE HYDROCHLORI DE, BUPRENORPHI NE HYDROCHLORI DE
BUPRENORPHI NE HYDROCHLORI DE AND NALOXONE HYDROCHLORI DE, BUPRENORPHI NE HYDROCHLORI DE
BUPRENORPHI NE HYDROCHLORI DE AND NALOXONE HYDROCHLORI DE , BUPRENORPHI NE HYDROCHLORI DE
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
BUSPI RONE HYDROCHLORI DE, BUSPI RONE HYDROCHLORI DE
BUSULFEX, BUSULFAN
BUTALBI TAL AND ACETAMI NOPHEN, ACETAMI NOPHEN
BUTALBI TAL, ACETAMI NOPHEN AND CAFFEI NE, ACETAMI NOPHEN
BUTALBI TAL, ACETAMI NOPHEN, CAFFEI NE AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
BUTALBI TAL, ASPI RI N AND CAFFEI NE, ASPI RI N
BUTALBI TAL, ASPI RI N, CAFFEI NE, AND CODEI NE PHOSPHATE, ASPI RI N
BUTAPAP, ACETAMI NOPHEN
BUTI SOL SODI UM, BUTABARBI TAL SODI UM
BUTOCONAZOLE NI TRATE, BUTOCONAZOLE NI TRATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE PRESERVATI VE FREE,
BUTRANS, BUPRENORPHI NE
BYDUREON, EXENATI DE SYNTHETI C
BYETTA, EXENATI DE SYNTHETI C
BYSTOLI C, NEBI VOLOL HYDROCHLORI DE
BUTORPHANOL TARTRATE
* * C * *
C- SOLVE- 2, ERYTHROMYCI N
CABERGOLI NE, CABERGOLI NE
CADUET, AMLODI PI NE BESYLATE
CAFCI T, CAFFEI NE CI TRATE
CAFERGOT, CAFFEI NE
CAFFEI NE CI TRATE, CAFFEI NE CI TRATE
CALAN, VERAPAMI L HYDROCHLORI DE
CALAN SR, VERAPAMI L HYDROCHLORI DE
CALCI J EX, CALCI TRI OL
CALCI POTRI ENE, CALCI POTRI ENE
CALCI POTRI ENE AND BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
CALCI TONI N- SALMON, CALCI TONI N SALMON
CALCI TRI OL, CALCI TRI OL
CALCI UM ACETATE, CALCI UM ACETATE
CALCI UM CARBONATE, FAMOTI DI NE AND MAGNESI UM HYDROXI DE, CALCI UM CARBONATE ( OTC)
CALCI UM CHLORI DE 10%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
CALCI UM DI SODI UM VERSENATE, EDETATE CALCI UM DI SODI UM
CALDOLOR, I BUPROFEN
CAMBI A, DI CLOFENAC POTASSI UM
CAMI LA, NORETHI NDRONE
CAMPRAL, ACAMPROSATE CALCI UM
CAMPTOSAR, I RI NOTECAN HYDROCHLORI DE
CANASA, MESALAMI NE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 9
APPENDI X A - PRODUCT NAME I NDEX
* * C * *
CANCI DAS, CASPOFUNGI N ACETATE
CANDESARTAN CI LEXETI L, CANDESARTAN CI LEXETI L
CANDESARTAN CI LEXETI L AND HYDROCHLOROTHI AZI DE, CANDESARTAN CI LEXETI L
CANTI L, MEPENZOLATE BROMI DE
CAPASTAT SULFATE, CAPREOMYCI N SULFATE
CAPECI TABI NE, CAPECI TABI NE
CAPEX, FLUOCI NOLONE ACETONI DE
CAPI TAL AND CODEI NE, ACETAMI NOPHEN
CAPI TAL SOLEI L 15, AVOBENZONE ( OTC)
CAPOTEN, CAPTOPRI L
CAPOZI DE 25/ 15, CAPTOPRI L
CAPOZI DE 25/ 25, CAPTOPRI L
CAPOZI DE 50/ 15, CAPTOPRI L
CAPOZI DE 50/ 25, CAPTOPRI L
CAPRELSA, VANDETANI B
CAPTOPRI L, CAPTOPRI L
CAPTOPRI L AND HYDROCHLOROTHI AZI DE, CAPTOPRI L
CARAC, FLUOROURACI L
CARAFATE, SUCRALFATE
CARBAGLU, CARGLUMI C ACI D
CARBAMAZEPI NE, CARBAMAZEPI NE
CARBATROL, CARBAMAZEPI NE
CARBI DOPA AND LEVODOPA, CARBI DOPA
CARBI DOPA, LEVODOPA AND ENTACAPONE, CARBI DOPA
CARBI NOXAMI NE MALEATE, CARBI NOXAMI NE MALEATE
CARBOCAI NE, MEPI VACAI NE HYDROCHLORI DE
CARBOPLATI N, CARBOPLATI N
CARDENE, NI CARDI PI NE HYDROCHLORI DE
CARDENE I N 0. 83%SODI UM CHLORI DE I N PLASTI C CONTAI NER, NI CARDI PI NE HYDROCHLORI DE
CARDENE I N 0. 86%SODI UM CHLORI DE I N PLASTI C CONTAI NER, NI CARDI PI NE HYDROCHLORI DE
CARDENE I N 4. 8%DEXTROSE I N PLASTI C CONTAI NER, NI CARDI PI NE HYDROCHLORI DE
CARDENE I N 5. 0%DEXTROSE I N PLASTI C CONTAI NER, NI CARDI PI NE HYDROCHLORI DE
CARDENE SR, NI CARDI PI NE HYDROCHLORI DE
CARDI OGEN- 82, RUBI DI UM CHLORI DE RB- 82
CARDI OLI TE, TECHNETI UM TC- 99M SESTAMI BI KI T
CARDI OPLEGI C I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
CARDI ZEM, DI LTI AZEM HYDROCHLORI DE
CARDI ZEM CD, DI LTI AZEM HYDROCHLORI DE
CARDI ZEM LA, DI LTI AZEM HYDROCHLORI DE
CARDURA, DOXAZOSI N MESYLATE
CARDURA XL, DOXAZOSI N MESYLATE
CARI SOPRODOL, CARI SOPRODOL
CARI SOPRODOL AND ASPI RI N, ASPI RI N
CARI SOPRODOL, ASPI RI N AND CODEI NE PHOSPHATE, ASPI RI N
CARNI TOR, LEVOCARNI TI NE
CARNI TOR SF, LEVOCARNI TI NE
CARTEOLOL HYDROCHLORI DE, CARTEOLOL HYDROCHLORI DE
CARTI A XT, DI LTI AZEM HYDROCHLORI DE
CARVEDI LOL, CARVEDI LOL
CASODEX, BI CALUTAMI DE
CATAFLAM, DI CLOFENAC POTASSI UM
CATAPRES, CLONI DI NE HYDROCHLORI DE
CATAPRES- TTS- 1, CLONI DI NE
CATAPRES- TTS- 2, CLONI DI NE
CATAPRES- TTS- 3, CLONI DI NE
CAVERJ ECT, ALPROSTADI L
CAVERJ ECT I MPULSE, ALPROSTADI L
CAYSTON, AZTREONAM
CEDAX, CEFTI BUTEN DI HYDRATE
CEENU, LOMUSTI NE
CEFACLOR, CEFACLOR
CEFADROXI L, CEFADROXI L/ CEFADROXI L HEMI HYDRATE
CEFAZOLI N AND DEXTROSE, CEFAZOLI N SODI UM
CEFAZOLI N SODI UM, CEFAZOLI N SODI UM
CEFDI NI R, CEFDI NI R





















34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 10
APPENDI X A - PRODUCT NAME I NDEX
* * C * *
CEFEPI ME AND DEXTROSE I N DUPLEX CONTAI NER, CEFEPI ME HYDROCHLORI DE
CEFEPI ME HYDROCHLORI DE, CEFEPI ME HYDROCHLORI DE
CEFEPI ME I N PLASTI C CONTAI NER, CEFEPI ME HYDROCHLORI DE
CEFOTAXI ME, CEFOTAXI ME SODI UM
CEFOTAXI ME SODI UM, CEFOTAXI ME SODI UM
CEFOTETAN, CEFOTETAN DI SODI UM
CEFOTETAN AND DEXTROSE I N DUPLEX CONTAI NER, CEFOTETAN DI SODI UM
CEFOXI TI N, CEFOXI TI N SODI UM
CEFOXI TI N AND DEXTROSE I N DUPLEX CONTAI NER, CEFOXI TI N SODI UM
CEFPODOXI ME PROXETI L, CEFPODOXI ME PROXETI L
CEFPROZI L, CEFPROZI L
CEFTAZI DI ME, CEFTAZI DI ME
CEFTAZI DI ME I N DEXTROSE CONTAI NER, CEFTAZI DI ME
CEFTI N, CEFUROXI ME AXETI L
CEFTRI AXONE, CEFTRI AXONE SODI UM
CEFTRI AXONE AND DEXTROSE I N DUPLEX CONTAI NER, CEFTRI AXONE SODI UM
CEFTRI AXONE I N PLASTI C CONTAI NER, CEFTRI AXONE SODI UM
CEFUROXI ME AND DEXTROSE I N DUPLEX CONTAI NER, CEFUROXI ME SODI UM
CEFUROXI ME AXETI L, CEFUROXI ME AXETI L
CEFUROXI ME SODI UM, CEFUROXI ME SODI UM
CELEBREX, CELECOXI B
CELESTONE SOLUSPAN, BETAMETHASONE ACETATE
CELEXA, CI TALOPRAM HYDROBROMI DE
CELLCEPT, MYCOPHENOLATE MOFETI L
CELLCEPT, MYCOPHENOLATE MOFETI L HYDROCHLORI DE
CELONTI N, METHSUXI MI DE
CENESTI N, ESTROGENS, CONJ UGATED SYNTHETI C A
CENTANY, MUPI ROCI N
CEPHALEXI N, CEPHALEXI N
CERETEC, TECHNETI UM TC- 99M EXAMETAZI ME KI T
CEREZYME, I MI GLUCERASE
CERUBI DI NE, DAUNORUBI CI N HYDROCHLORI DE
CERVI DI L, DI NOPROSTONE
CESAMET, NABI LONE
CETAMI DE, SULFACETAMI DE SODI UM
CETI RI ZI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE AND PSEUDOEPHEDRI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CETI RI ZI NE HYDROCHLORI DE HI VES, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETRAXAL, CI PROFLOXACI N HYDROCHLORI DE
CETROTI DE, CETRORELI X
CEVI MELI NE, CEVI MELI NE HYDROCHLORI DE
CEVI MELI NE HYDROCHLORI DE, CEVI MELI NE HYDROCHLORI DE
CHANTI X, VARENI CLI NE TARTRATE
CHEMET, SUCCI MER
CHENODI OL, CHENODI OL
CHG SCRUB, CHLORHEXI DI NE GLUCONATE ( OTC)
CHI LDREN' S ADVI L, I BUPROFEN ( OTC)
CHI LDREN' S ADVI L ALLERGY SI NUS, CHLORPHENI RAMI NE MALEATE ( OTC)
CHI LDREN' S ADVI L COLD, I BUPROFEN ( OTC)
CHI LDREN' S ADVI L- FLAVORED, I BUPROFEN ( OTC)
CHI LDREN' S ALLEGRA ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S ALLEGRA HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CLARI TI N, LORATADI NE ( OTC)
CHI LDREN' S ELI XSURE, I BUPROFEN ( OTC)
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S I BUPROFEN, I BUPROFEN ( OTC)
CHI LDREN' S MOTRI N, I BUPROFEN ( OTC)
CHI LDREN' S MOTRI N COLD, I BUPROFEN ( OTC)
CHI LDREN' S ZYRTEC ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S ZYRTEC HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)












34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 11
APPENDI X A - PRODUCT NAME I NDEX
* * C * *
CHI RHOSTI M, SECRETI N SYNTHETI C HUMAN
CHLOR- TRI METON, CHLORPHENI RAMI NE MALEATE ( OTC)
CHLORAMPHENI COL SODI UM SUCCI NATE, CHLORAMPHENI COL SODI UM SUCCI NATE
CHLORAPREP ONE- STEP, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORAPREP ONE- STEP FREPP, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORAPREP ONE- STEP SEPP, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORAPREP SI NGLE SWABSTI CK, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORAPREP TRI PLE SWABSTI CK, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORAPREP WI TH TI NT, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORDI AZEPOXI DE AND AMI TRI PTYLI NE HYDROCHLORI DE, AMI TRI PTYLI NE HYDROCHLORI DE
CHLORDI AZEPOXI DE HYDROCHLORI DE, CHLORDI AZEPOXI DE HYDROCHLORI DE
CHLORHEXI DI NE GLUCONATE, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORHEXI DI NE GLUCONATE, CHLORHEXI DI NE GLUCONATE
CHLOROPROCAI NE HYDROCHLORI DE, CHLOROPROCAI NE HYDROCHLORI DE
CHLOROQUI NE PHOSPHATE, CHLOROQUI NE PHOSPHATE
CHLOROTHI AZI DE, CHLOROTHI AZI DE
CHLOROTHI AZI DE SODI UM, CHLOROTHI AZI DE SODI UM
CHLORPHENI RAMI NE MALEATE, CHLORPHENI RAMI NE MALEATE ( OTC)
CHLORPROMAZI NE HYDROCHLORI DE, CHLORPROMAZI NE HYDROCHLORI DE
CHLORPROPAMI DE, CHLORPROPAMI DE
CHLORTHALI DONE, CHLORTHALI DONE
CHLORZOXAZONE, CHLORZOXAZONE
CHOLAC, LACTULOSE
CHOLEDYL SA, OXTRI PHYLLI NE
CHOLESTYRAMI NE, CHOLESTYRAMI NE
CHOLESTYRAMI NE LI GHT, CHOLESTYRAMI NE
CHOLETEC, TECHNETI UM TC- 99M MEBROFENI N KI T
CHOLI NE C- 11, CHOLI NE C- 11
CHOLOGRAFI N MEGLUMI NE, I ODI PAMI DE MEGLUMI NE
CHORI ONI C GONADOTROPI N, GONADOTROPI N, CHORI ONI C
CHROMI C CHLORI DE I N PLASTI C CONTAI NER, CHROMI C CHLORI DE
CI ALI S, TADALAFI L
CI CLOPI ROX, CI CLOPI ROX
CI DA- STAT, CHLORHEXI DI NE GLUCONATE ( OTC)
CI DOFOVI R, CI DOFOVI R
CI LOSTAZOL, CI LOSTAZOL
CI LOXAN, CI PROFLOXACI N HYDROCHLORI DE
CI METI DI NE, CI METI DI NE ( OTC)
CI METI DI NE, CI METI DI NE
CI METI DI NE HYDROCHLORI DE, CI METI DI NE HYDROCHLORI DE
CI PRO, CI PROFLOXACI N
CI PRO, CI PROFLOXACI N HYDROCHLORI DE
CI PRO HC, CI PROFLOXACI N HYDROCHLORI DE
CI PRO I N DEXTROSE 5%I N PLASTI C CONTAI NER, CI PROFLOXACI N
CI PRODEX, CI PROFLOXACI N
CI PROFLOXACI N, CI PROFLOXACI N
CI PROFLOXACI N EXTENDED RELEASE, CI PROFLOXACI N
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
CI PROFLOXACI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, CI PROFLOXACI N
CI S- MDP, TECHNETI UM TC- 99M MEDRONATE KI T
CI S- PYRO, TECHNETI UM TC- 99M PYROPHOSPHATE KI T
CI SATRACURI UM BESYLATE, CI SATRACURI UM BESYLATE
CI SATRACURI UM BESYLATE PRESERVATI VE FREE, CI SATRACURI UM BESYLATE
CI SPLATI N, CI SPLATI N
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
CI TANEST FORTE DENTAL, EPI NEPHRI NE BI TARTRATE
CLADRI BI NE, CLADRI BI NE
CLAFORAN, CEFOTAXI ME SODI UM
CLAFORAN I N DEXTROSE 5%I N PLASTI C CONTAI NER, CEFOTAXI ME SODI UM
CLARAVI S, I SOTRETI NOI N
CLARI NEX, DESLORATADI NE
CLARI NEX D 24 HOUR, DESLORATADI NE
CLARI NEX- D 12 HOUR, DESLORATADI NE
CLARI THROMYCI N, CLARI THROMYCI N
CLARI TI N, LORATADI NE ( OTC)






34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 12
APPENDI X A - PRODUCT NAME I NDEX
* * C * *
CLARI TI N HI VES RELI EF, LORATADI NE ( OTC)
CLARI TI N HI VES RELI EF REDI TAB, LORATADI NE ( OTC)
CLARI TI N REDI TABS, LORATADI NE ( OTC)
CLARI TI N- D, LORATADI NE ( OTC)
CLARI TI N- D 24 HOUR, LORATADI NE ( OTC)
CLEMASTI NE FUMARATE, CLEMASTI NE FUMARATE ( OTC)
CLEMASTI NE FUMARATE, CLEMASTI NE FUMARATE
CLEOCI N, CLI NDAMYCI N PALMI TATE HYDROCHLORI DE
CLEOCI N, CLI NDAMYCI N PHOSPHATE
CLEOCI N HYDROCHLORI DE, CLI NDAMYCI N HYDROCHLORI DE
CLEOCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
CLEOCI N PHOSPHATE I N DEXTROSE 5%I N PLASTI C CONTAI NER, CLI NDAMYCI N PHOSPHATE
CLEOCI N T, CLI NDAMYCI N PHOSPHATE
CLEVI PREX, CLEVI DI PI NE
CLI MARA, ESTRADI OL
CLI MARA PRO, ESTRADI OL
CLI NDA- DERM, CLI NDAMYCI N PHOSPHATE
CLI NDAGEL, CLI NDAMYCI N PHOSPHATE
CLI NDAMYCI N HYDROCHLORI DE, CLI NDAMYCI N HYDROCHLORI DE
CLI NDAMYCI N PALMI TATE HYDROCHLORI DE, CLI NDAMYCI N PALMI TATE HYDROCHLORI DE
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
CLI NDAMYCI N PHOSPHATE AND BENZOYL PEROXI DE, BENZOYL PEROXI DE
CLI NDAMYCI N PHOSPHATE I N 5%DEXTROSE I N PLASTI C CONTAI NER, CLI NDAMYCI N PHOSPHATE
CLI NDAMYCI N PHOSPHATE I N DEXTROSE 5%, CLI NDAMYCI N PHOSPHATE
CLI NDESSE, CLI NDAMYCI N PHOSPHATE
CLI NDETS, CLI NDAMYCI N PHOSPHATE
CLI NI MI X 2. 75/ 10 SULFI TE FREE I N DEXTROSE 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 2. 75/ 25 SULFI TE FREE I N DEXTROSE 25%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 2. 75/ 5 SULFI TE FREE I N DEXTROSE 5%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 4. 25/ 10 SULFI TE FREE I N DEXTROSE 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 4. 25/ 20 SULFI TE FREE I N DEXTROSE 20%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 4. 25/ 25 SULFI TE FREE I N DEXTROSE 25%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 4. 25/ 5 SULFI TE FREE I N DEXTROSE 5%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 5/ 10 SULFI TE FREE I N DEXTROSE 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 5/ 15 SULFI TE FREE I N DEXTROSE 15%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 5/ 20 SULFI TE FREE I N DEXTROSE 20%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 5/ 25 SULFI TE FREE I N DEXTROSE 25%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 5/ 35 SULFI TE FREE I N DEXTROSE 35%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X E 2. 75/ 10 SULFI TE- FREE W/ ELECT I N DEXTROSE 10%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 2. 75/ 25 SULFI TE- FREE W/ ELECT I N DEXTROSE 25%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 2. 75/ 5 SULFI TE- FREE W/ ELECT I N DEXTROSE 5%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 4. 25/ 10 SULFI TE- FREE W/ ELECT I N DEXTROSE 10%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 4. 25/ 20 SULFI TE- FREE W/ ELECT I N DEXTROSE 20%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 4. 25/ 25 SULFI TE- FREE W/ ELECT I N DEXTROSE 25%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 4. 25/ 5 SULFI TE- FREE W/ ELECT I N DEXTROSE 5%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 5/ 10 SULFI TE- FREE W/ ELECT I N DEXTROSE 10%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 5/ 15 SULFI TE- FREE W/ ELECT I N DEXTROSE 15%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 5/ 20 SULFI TE- FREE W/ ELECT I N 20%DEXTROSE W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 5/ 25 SULFI TE- FREE W/ ELECT I N DEXTROSE 25%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 5/ 35 SULFI TE- FREE W/ ELECT I N DEXTROSE 35%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI SOL 15%SULFI TE FREE I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NOLI PI D 20%, OLI VE OI L
CLI NORI L, SULI NDAC
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
CLOBETASOL PROPI ONATE ( EMOLLI ENT) , CLOBETASOL PROPI ONATE
CLOBEX, CLOBETASOL PROPI ONATE
CLODERM, CLOCORTOLONE PI VALATE
CLOLAR, CLOFARABI NE
CLOMI D, CLOMI PHENE CI TRATE
CLOMI PHENE CI TRATE, CLOMI PHENE CI TRATE
CLOMI PRAMI NE HYDROCHLORI DE, CLOMI PRAMI NE HYDROCHLORI DE
CLONAZEPAM, CLONAZEPAM
CLONI DI NE, CLONI DI NE
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
CLONI DI NE HYDROCHLORI DE , CLONI DI NE HYDROCHLORI DE



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 13
APPENDI X A - PRODUCT NAME I NDEX
* * C * *
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
CLORAZEPATE DI POTASSI UM, CLORAZEPATE DI POTASSI UM
CLORPRES, CHLORTHALI DONE
CLOTRI MAZOLE, CLOTRI MAZOLE ( OTC)
CLOTRI MAZOLE, CLOTRI MAZOLE
CLOTRI MAZOLE AND BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
CLOZAPI NE, CLOZAPI NE
CLOZARI L, CLOZAPI NE
COARTEM, ARTEMETHER
CODEI NE SULFATE, CODEI NE SULFATE
COGENTI N, BENZTROPI NE MESYLATE
COL- PROBENECI D, COLCHI CI NE
COLAZAL, BALSALAZI DE DI SODI UM
COLCRYS, COLCHI CI NE
COLESTI D, COLESTI POL HYDROCHLORI DE
COLESTI POL HYDROCHLORI DE, COLESTI POL HYDROCHLORI DE
COLGATE TOTAL, SODI UM FLUORI DE ( OTC)
COLI STI METHATE SODI UM, COLI STI METHATE SODI UM
COLOCORT, HYDROCORTI SONE
COLY- MYCI N M, COLI STI METHATE SODI UM
COLY- MYCI N S, COLI STI N SULFATE
COLYTE, POLYETHYLENE GLYCOL 3350
COLYTE WI TH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
COMBI GAN, BRI MONI DI NE TARTRATE
COMBI PATCH, ESTRADI OL
COMBI VENT, ALBUTEROL SULFATE
COMBI VENT RESPI MAT, ALBUTEROL SULFATE
COMBI VI R, LAMI VUDI NE
COMETRI Q, CABOZANTI NI B S- MALATE
COMMI T, NI COTI NE POLACRI LEX ( OTC)
COMPLERA, EMTRI CI TABI NE
COMPRO, PROCHLORPERAZI NE
COMTAN, ENTACAPONE
CONCERTA, METHYLPHENI DATE HYDROCHLORI DE
CONDYLOX, PODOFI LOX
CONRAY, I OTHALAMATE MEGLUMI NE
CONRAY 30, I OTHALAMATE MEGLUMI NE
CONRAY 43, I OTHALAMATE MEGLUMI NE
CONSTI LAC, LACTULOSE
CONSTULOSE, LACTULOSE
CONZI P, TRAMADOL HYDROCHLORI DE
COPAXONE, GLATI RAMER ACETATE
COPEGUS, RI BAVI RI N
CORDARONE, AMI ODARONE HYDROCHLORI DE
CORDRAN, FLURANDRENOLI DE
CORDRAN SP, FLURANDRENOLI DE
COREG, CARVEDI LOL
COREG CR, CARVEDI LOL PHOSPHATE
CORGARD, NADOLOL
CORLOPAM, FENOLDOPAM MESYLATE
CORMAX, CLOBETASOL PROPI ONATE
CORTEF, HYDROCORTI SONE
CORTENEMA, HYDROCORTI SONE
CORTI FOAM, HYDROCORTI SONE ACETATE
CORTI SONE ACETATE, CORTI SONE ACETATE
CORTI SPORI N, BACI TRACI N ZI NC
CORTI SPORI N, HYDROCORTI SONE
CORTI SPORI N, HYDROCORTI SONE ACETATE
CORTROSYN, COSYNTROPI N
CORVERT, I BUTI LI DE FUMARATE
CORZI DE, BENDROFLUMETHI AZI DE
COSMEGEN, DACTI NOMYCI N
COSOPT, DORZOLAMI DE HYDROCHLORI DE
COSOPT PF, DORZOLAMI DE HYDROCHLORI DE
COSYNTROPI N, COSYNTROPI N

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 14
APPENDI X A - PRODUCT NAME I NDEX
* * C * *
COUMADI N, WARFARI N SODI UM
COVERA- HS, VERAPAMI L HYDROCHLORI DE
COZAAR, LOSARTAN POTASSI UM
CREON, PANCRELI PASE ( AMYLASE
CRESTOR, ROSUVASTATI N CALCI UM
CRI NONE, PROGESTERONE
CRI XI VAN, I NDI NAVI R SULFATE
CROLOM, CROMOLYN SODI UM
CROMOLYN SODI UM, CROMOLYN SODI UM ( OTC)
CROMOLYN SODI UM, CROMOLYN SODI UM
CROTAN, CROTAMI TON
CRYSELLE, ETHI NYL ESTRADI OL
CUBI CI N, DAPTOMYCI N
CUPRI C CHLORI DE I N PLASTI C CONTAI NER, CUPRI C CHLORI DE
CUPRI MI NE, PENI CI LLAMI NE
CUROSURF, PORACTANT ALFA
CUTI VATE, FLUTI CASONE PROPI ONATE
CUVPOSA, GLYCOPYRROLATE
CYANOCOBALAMI N, CYANOCOBALAMI N
CYANOKI T, HYDROXOCOBALAMI N
CYCLAFEM 1/ 35, ETHI NYL ESTRADI OL
CYCLAFEM 7/ 7/ 7, ETHI NYL ESTRADI OL
CYCLESSA, DESOGESTREL
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
CYCLOGYL, CYCLOPENTOLATE HYDROCHLORI DE
CYCLOMYDRI L, CYCLOPENTOLATE HYDROCHLORI DE
CYCLOPHOSPHAMI DE, CYCLOPHOSPHAMI DE
CYCLOSET, BROMOCRI PTI NE MESYLATE
CYCLOSPORI NE, CYCLOSPORI NE
CYKLOKAPRON, TRANEXAMI C ACI D
CYMBALTA, DULOXETI NE HYDROCHLORI DE
CYPROHEPTADI NE HYDROCHLORI DE, CYPROHEPTADI NE HYDROCHLORI DE
CYSTADANE, BETAI NE HYDROCHLORI DE
CYSTAGON, CYSTEAMI NE BI TARTRATE
CYSTARAN, CYSTEAMI NE HYDROCHLORI DE
CYSTO- CONRAY I I , I OTHALAMATE MEGLUMI NE
CYSTOGRAFI N, DI ATRI ZOATE MEGLUMI NE
CYSTOGRAFI N DI LUTE, DI ATRI ZOATE MEGLUMI NE
CYSVI EWKI T, HEXAMI NOLEVULI NATE HYDROCHLORI DE
CYTARABI NE, CYTARABI NE
CYTOMEL, LI OTHYRONI NE SODI UM
CYTOSAR- U, CYTARABI NE
CYTOTEC, MI SOPROSTOL
CYTOVENE, GANCI CLOVI R SODI UM
CYTOXAN ( LYOPHI LI ZED) , CYCLOPHOSPHAMI DE
* * D * *
D. H. E. 45, DI HYDROERGOTAMI NE MESYLATE
DACARBAZI NE, DACARBAZI NE
DACOGEN, DECI TABI NE
DACTI NOMYCI N, DACTI NOMYCI N
DALI RESP, ROFLUMI LAST
DANAZOL, DANAZOL
DANTRI UM, DANTROLENE SODI UM
DANTROLENE SODI UM, DANTROLENE SODI UM
DAPSONE, DAPSONE
DARAPRI M, PYRI METHAMI NE
DASETTA 1/ 35, ETHI NYL ESTRADI OL
DASETTA 7/ 7/ 7, ETHI NYL ESTRADI OL
DATSCAN, I OFLUPANE I - 123
DAUNORUBI CI N HYDROCHLORI DE, DAUNORUBI CI N HYDROCHLORI DE
DAUNOXOME, DAUNORUBI CI N CI TRATE
DAYPRO, OXAPROZI N
DAYSEE, ETHI NYL ESTRADI OL
DAYTRANA, METHYLPHENI DATE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 15
APPENDI X A - PRODUCT NAME I NDEX
* * D * *
DDAVP, DESMOPRESSI N ACETATE
DDAVP ( NEEDS NO REFRI GERATI ON) , DESMOPRESSI N ACETATE
DECI TABI NE, DECI TABI NE
DEFEROXAMI NE MESYLATE, DEFEROXAMI NE MESYLATE
DEFI NI TY, PERFLUTREN
DELATESTRYL, TESTOSTERONE ENANTHATE
DELESTROGEN, ESTRADI OL VALERATE
DELFLEX W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 1. 5%LOWMAGNESI UM I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 1. 5%LOWMAGNESI UM LOWCALCI UM I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 2. 5%LOWMAGNESI UM I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 2. 5%LOWMAGNESI UM LOWCALCI UM I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 3. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 4. 25%LOWMAGNESI UM I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 4. 25%LOWMAGNESI UM LOWCALCI UM I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX- LM W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX- LM W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX- LM W/ DEXTROSE 3. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX- LM W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELSYM, DEXTROMETHORPHAN POLI STI REX ( OTC)
DELZI COL, MESALAMI NE
DEMADEX, TORSEMI DE
DEMECLOCYCLI NE HYDROCHLORI DE, DEMECLOCYCLI NE HYDROCHLORI DE
DEMEROL, MEPERI DI NE HYDROCHLORI DE
DEMSER, METYROSI NE
DENAVI R, PENCI CLOVI R SODI UM
DENDRI D, I DOXURI DI NE
DEPACON, VALPROATE SODI UM
DEPAKENE, VALPROI C ACI D
DEPAKOTE, DI VALPROEX SODI UM
DEPAKOTE ER, DI VALPROEX SODI UM
DEPEN, PENI CI LLAMI NE
DEPO- ESTRADI OL, ESTRADI OL CYPI ONATE
DEPO- MEDROL, METHYLPREDNI SOLONE ACETATE
DEPO- PROVERA, MEDROXYPROGESTERONE ACETATE
DEPO- SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE
DEPO- TESTOSTERONE, TESTOSTERONE CYPI ONATE
DEPOCYT, CYTARABI NE
DERMA- SMOOTHE/ FS, FLUOCI NOLONE ACETONI DE
DERMABET, BETAMETHASONE VALERATE
DERMATOP, PREDNI CARBATE
DERMATOP E EMOLLI ENT, PREDNI CARBATE
DERMOTI C, FLUOCI NOLONE ACETONI DE
DESFERAL, DEFEROXAMI NE MESYLATE
DESI PRAMI NE HYDROCHLORI DE, DESI PRAMI NE HYDROCHLORI DE
DESLORATADI NE, DESLORATADI NE
DESLORATADI NE AND PSEUDOEPHEDRI NE SULFATE 24 HOUR, DESLORATADI NE
DESMOPRESSI N ACETATE, DESMOPRESSI N ACETATE
DESMOPRESSI N ACETATE , DESMOPRESSI N ACETATE
DESMOPRESSI N ACETATE ( NEEDS NO REFRI GERATI ON) , DESMOPRESSI N ACETATE
DESOGEN, DESOGESTREL
DESOGESTREL AND ETHI NYL ESTRADI OL, DESOGESTREL
DESONATE, DESONI DE
DESONI DE, DESONI DE
DESOWEN, DESONI DE
DESOXI METASONE, DESOXI METASONE
DESOXYN, METHAMPHETAMI NE HYDROCHLORI DE
DESVENLAFAXI NE, DESVENLAFAXI NE
DESVENLAFAXI NE FUMARATE, DESVENLAFAXI NE FUMARATE
DETROL, TOLTERODI NE TARTRATE
DETROL LA, TOLTERODI NE TARTRATE
DEXAMETHASONE, DEXAMETHASONE
DEXAMETHASONE I NTENSOL, DEXAMETHASONE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 16
APPENDI X A - PRODUCT NAME I NDEX
* * D * *
DEXAMETHASONE SODI UM PHOSPHATE, DEXAMETHASONE SODI UM PHOSPHATE
DEXASPORI N, DEXAMETHASONE
DEXBROMPHENI RAMI NE MALEATE AND PSEUDOEPHEDRI NE SULFATE, DEXBROMPHENI RAMI NE MALEATE ( OTC)
DEXCHLORPHENI RAMI NE MALEATE, DEXCHLORPHENI RAMI NE MALEATE
DEXEDRI NE, DEXTROAMPHETAMI NE SULFATE
DEXFERRUM, I RON DEXTRAN
DEXI LANT, DEXLANSOPRAZOLE
DEXMETHYLPHENI DATE HYDROCHLORI DE, DEXMETHYLPHENI DATE HYDROCHLORI DE
DEXRAZOXANE HYDROCHLORI DE, DEXRAZOXANE HYDROCHLORI DE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMI NE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMI NE
DEXTROAMPHETAMI NE SULFATE, DEXTROAMPHETAMI NE SULFATE
DEXTROMETHORPHAN POLI STI REX, DEXTROMETHORPHAN POLI STI REX ( OTC)
DEXTROSE 10%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 10%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 10%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%I N HALF- STRENGTH LACTATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DEXTROSE 20%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 25%, DEXTROSE
DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 30%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 40%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND ELECTROLYTE NO 75 I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND ELECTROLYTE NO. 48 I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DEXTROSE 5%AND POTASSI UM CHLORI DE 0. 075%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND POTASSI UM CHLORI DE 0. 15%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND POTASSI UM CHLORI DE 0. 224%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND POTASSI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N ACETATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DEXTROSE 5%I N LACTATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DEXTROSE 5%I N SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 10MEQ, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 15MEQ ( K) , DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 20MEQ, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 20MEQ ( K) , DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 30MEQ, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 40MEQ, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 5MEQ, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 5MEQ ( K) , DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 10MEQ I N PLASTI C CONTAI NER,
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 15MEQ I N PLASTI C CONTAI NER,
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 20MEQ I N PLASTI C CONTAI NER,
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 30MEQ I N PLASTI C CONTAI NER,
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 17
APPENDI X A - PRODUCT NAME I NDEX
* * D * *
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 40MEQ I N PLASTI C CONTAI NER,
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 5MEQ I N PLASTI C CONTAI NER,
DEXTROSE 5%, SODI UM CHLORI DE 0. 45%AND POTASSI UM CHLORI DE 20MEQ ( K) I N PLASTI C CONTAI NER,
DEXTROSE 50%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 60%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 70%I N PLASTI C CONTAI NER, DEXTROSE
DI ABETA, GLYBURI DE
DI ABI NESE, CHLORPROPAMI DE
DI ALYTE CONCENTRATE W/ DEXTROSE 30%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ALYTE CONCENTRATE W/ DEXTROSE 50%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ALYTE LM/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ALYTE LM/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ALYTE LM/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI AMOX, ACETAZOLAMI DE
DI ANEAL 137 W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL 137 W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL 137 W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL LOWCALCI UM W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL LOWCALCI UM W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL LOWCALCI UM W/ DEXTROSE 3. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL LOWCALCI UM W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 1 W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 1 W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 1 W/ DEXTROSE 3. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 1 W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 2 W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 2 W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 2 W/ DEXTROSE 3. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 2 W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ASTAT, DI AZEPAM
DI ASTAT ACUDI AL, DI AZEPAM
DI AZEPAM, DI AZEPAM
DI AZEPAM I NTENSOL, DI AZEPAM
DI BENZYLI NE, PHENOXYBENZAMI NE HYDROCHLORI DE
DI CLEGI S, DOXYLAMI NE SUCCI NATE
DI CLOFENAC POTASSI UM, DI CLOFENAC POTASSI UM
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
DI CLOFENAC SODI UM , DI CLOFENAC SODI UM
DI CLOFENAC SODI UM AND MI SOPROSTOL, DI CLOFENAC SODI UM
DI CLOXACI LLI N SODI UM, DI CLOXACI LLI N SODI UM
DI CYCLOMI NE HYDROCHLORI DE, DI CYCLOMI NE HYDROCHLORI DE
DI CYCLOMI NE HYDROCHLORI DE ( PRESERVATI VE- FREE) , DI CYCLOMI NE HYDROCHLORI DE
DI DANOSI NE, DI DANOSI NE
DI DREX, BENZPHETAMI NE HYDROCHLORI DE
DI DRONEL, ETI DRONATE DI SODI UM
DI ETHYLPROPI ON HYDROCHLORI DE, DI ETHYLPROPI ON HYDROCHLORI DE
DI FFERI N, ADAPALENE
DI FI CI D, FI DAXOMI CI N
DI FLORASONE DI ACETATE, DI FLORASONE DI ACETATE
DI FLUCAN, FLUCONAZOLE
DI FLUCAN I N DEXTROSE 5%I N PLASTI C CONTAI NER, FLUCONAZOLE
DI FLUCAN I N SODI UM CHLORI DE 0. 9%, FLUCONAZOLE
DI FLUCAN I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, FLUCONAZOLE
DI FLUNI SAL, DI FLUNI SAL
DI GOXI N, DI GOXI N
DI HYDROERGOTAMI NE MESYLATE, DI HYDROERGOTAMI NE MESYLATE
DI LACOR XR, DI LTI AZEM HYDROCHLORI DE
DI LANTI N, PHENYTOI N
DI LANTI N, PHENYTOI N SODI UM
DI LANTI N- 125, PHENYTOI N
DI LATRATE- SR, I SOSORBI DE DI NI TRATE
DI LAUDI D, HYDROMORPHONE HYDROCHLORI DE
DI LAUDI D- HP, HYDROMORPHONE HYDROCHLORI DE
DI LT- CD, DI LTI AZEM HYDROCHLORI DE
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 18
APPENDI X A - PRODUCT NAME I NDEX
* * D * *
DI LTZAC, DI LTI AZEM HYDROCHLORI DE
DI MENHYDRI NATE, DI MENHYDRI NATE
DI METHYL SULFOXI DE, DI METHYL SULFOXI DE
DI OVAN, VALSARTAN
DI OVAN HCT, HYDROCHLOROTHI AZI DE
DI PENTUM, OLSALAZI NE SODI UM
DI PHENHYDRAMI NE HYDROCHLORI DE, DI PHENHYDRAMI NE HYDROCHLORI DE
DI PHENHYDRAMI NE HYDROCHLORI DE PRESERVATI VE FREE, DI PHENHYDRAMI NE HYDROCHLORI DE
DI PHENOXYLATE HYDROCHLORI DE AND ATROPI NE SULFATE, ATROPI NE SULFATE
DI PI VEFRI N HYDROCHLORI DE, DI PI VEFRI N HYDROCHLORI DE
DI PRI VAN, PROPOFOL
DI PROLENE, BETAMETHASONE DI PROPI ONATE
DI PROLENE AF, BETAMETHASONE DI PROPI ONATE
DI PYRI DAMOLE, DI PYRI DAMOLE
DI SOPHROL, DEXBROMPHENI RAMI NE MALEATE ( OTC)
DI SOPYRAMI DE PHOSPHATE, DI SOPYRAMI DE PHOSPHATE
DI SULFI RAM, DI SULFI RAM
DI SULFI RAM , DI SULFI RAM
DI TROPAN XL, OXYBUTYNI N CHLORI DE
DI URI L, CHLOROTHI AZI DE
DI URI L, CHLOROTHI AZI DE SODI UM
DI VALPROEX SODI UM, DI VALPROEX SODI UM
DI VI GEL, ESTRADI OL
DOBUTAMI NE HYDROCHLORI DE, DOBUTAMI NE HYDROCHLORI DE
DOBUTAMI NE HYDROCHLORI DE I N DEXTROSE 5%, DOBUTAMI NE HYDROCHLORI DE
DOBUTAMI NE HYDROCHLORI DE I N DEXTROSE 5%I N PLASTI C CONTAI NER, DOBUTAMI NE HYDROCHLORI DE
DOCEFREZ, DOCETAXEL
DOCETAXEL, DOCETAXEL
DOLOPHI NE HYDROCHLORI DE, METHADONE HYDROCHLORI DE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DOPAMI NE HYDROCHLORI DE, DOPAMI NE HYDROCHLORI DE
DOPAMI NE HYDROCHLORI DE AND DEXTROSE 5%, DOPAMI NE HYDROCHLORI DE
DOPAMI NE HYDROCHLORI DE AND DEXTROSE 5%I N PLASTI C CONTAI NER, DOPAMI NE HYDROCHLORI DE
DOPAMI NE HYDROCHLORI DE I N DEXTROSE 5%I N PLASTI C CONTAI NER, DOPAMI NE HYDROCHLORI DE
DOPRAM, DOXAPRAM HYDROCHLORI DE
DORAL, QUAZEPAM
DORI BAX, DORI PENEM
DORYX, DOXYCYCLI NE HYCLATE
DORZOLAMI DE HYDROCHLORI DE, DORZOLAMI DE HYDROCHLORI DE
DORZOLAMI DE HYDROCHLORI DE AND TI MOLOL MALEATE, DORZOLAMI DE HYDROCHLORI DE
DOTAREM, GADOTERATE MEGLUMI NE
DOVONEX, CALCI POTRI ENE
DOXAPRAM HYDROCHLORI DE, DOXAPRAM HYDROCHLORI DE
DOXAZOSI N MESYLATE, DOXAZOSI N MESYLATE
DOXEPI N HYDROCHLORI DE, DOXEPI N HYDROCHLORI DE
DOXERCALCI FEROL, DOXERCALCI FEROL
DOXI L ( LI POSOMAL) , DOXORUBI CI N HYDROCHLORI DE
DOXORUBI CI N HYDROCHLORI DE, DOXORUBI CI N HYDROCHLORI DE
DOXORUBI CI N HYDROCHLORI DE ( LI POSOMAL) , DOXORUBI CI N HYDROCHLORI DE
DOXY 100, DOXYCYCLI NE HYCLATE
DOXY 200, DOXYCYCLI NE HYCLATE
DOXYCYCLI NE, DOXYCYCLI NE
DOXYCYCLI NE, DOXYCYCLI NE HYCLATE
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
DOXYLAMI NE SUCCI NATE, DOXYLAMI NE SUCCI NATE ( OTC)
DRAXI MAGE MDP- 25, TECHNETI UM TC- 99M MEDRONATE
DRI SDOL, ERGOCALCI FEROL
DRI XORAL, DEXBROMPHENI RAMI NE MALEATE ( OTC)
DRI XORAL PLUS, ACETAMI NOPHEN ( OTC)
DRONABI NOL, DRONABI NOL
DROPERI DOL, DROPERI DOL
DROSPI RENONE AND ETHI NYL ESTRADI OL, DROSPI RENONE
DROXI A, HYDROXYUREA
DTI C- DOME, DACARBAZI NE
DTPA, TECHNETI UM TC- 99M PENTETATE KI T




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 19
APPENDI X A - PRODUCT NAME I NDEX
* * D * *
DUAC, BENZOYL PEROXI DE
DUAVEE, BAZEDOXI FENE ACETATE
DUETACT, GLI MEPI RI DE
DUEXI S, FAMOTI DI NE
DULERA, FORMOTEROL FUMARATE
DULOXETI NE HYDROCHLORI DE, DULOXETI NE HYDROCHLORI DE
DUODOTE, ATROPI NE
DUONEB, ALBUTEROL SULFATE
DURACLON, CLONI DI NE HYDROCHLORI DE
DURAGESI C- 100, FENTANYL
DURAGESI C- 12, FENTANYL
DURAGESI C- 25, FENTANYL
DURAGESI C- 50, FENTANYL
DURAGESI C- 75, FENTANYL
DURAMORPH PF, MORPHI NE SULFATE
DURAPREP, I ODI NE POVACRYLEX ( OTC)
DUREZOL, DI FLUPREDNATE
DUTASTERI DE, DUTASTERI DE
DUTOPROL, HYDROCHLOROTHI AZI DE
DUVOI D, BETHANECHOL CHLORI DE
DYAZI DE, HYDROCHLOROTHI AZI DE
DYMI STA, AZELASTI NE HYDROCHLORI DE
DYNA- HEX, CHLORHEXI DI NE GLUCONATE ( OTC)
DYNACI N, MI NOCYCLI NE HYDROCHLORI DE
DYRENI UM, TRI AMTERENE
* * E * *
E- Z SCRUB 201, POVI DONE- I ODI NE ( OTC)
E- Z SCRUB 241, POVI DONE- I ODI NE ( OTC)
E. E. S. , ERYTHROMYCI N ETHYLSUCCI NATE
E. E. S. 200, ERYTHROMYCI N ETHYLSUCCI NATE
E. E. S. 400, ERYTHROMYCI N ETHYLSUCCI NATE
EC- NAPROSYN, NAPROXEN
ECONAZOLE NI TRATE, ECONAZOLE NI TRATE
ECOZA, ECONAZOLE NI TRATE
EDARBI , AZI LSARTAN KAMEDOXOMI L
EDARBYCLOR, AZI LSARTAN KAMEDOXOMI L
EDECRI N, ETHACRYNATE SODI UM
EDECRI N, ETHACRYNI C ACI D
EDEX, ALPROSTADI L
EDLUAR, ZOLPI DEM TARTRATE
EDURANT, RI LPI VI RI NE HYDROCHLORI DE
EFFEXOR XR, VENLAFAXI NE HYDROCHLORI DE
EFFI ENT, PRASUGREL HYDROCHLORI DE
EFUDEX, FLUOROURACI L
EGRI FTA, TESAMORELI N ACETATE
ELDEPRYL, SELEGI LI NE HYDROCHLORI DE
ELELYSO, TALI GLUCERASE ALFA
ELESTAT, EPI NASTI NE HYDROCHLORI DE
ELESTRI N, ESTRADI OL
ELI DEL, PI MECROLI MUS
ELI GARD, LEUPROLI DE ACETATE
ELI MI TE, PERMETHRI N
ELI NEST, ETHI NYL ESTRADI OL
ELI PHOS, CALCI UM ACETATE
ELI QUI S, API XABAN
ELI XOPHYLLI N, THEOPHYLLI NE
ELLA, ULI PRI STAL ACETATE
ELLENCE, EPI RUBI CI N HYDROCHLORI DE
ELLI OTTS B SOLUTI ON, CALCI UM CHLORI DE
ELMI RON, PENTOSAN POLYSULFATE SODI UM
ELOCON, MOMETASONE FUROATE
ELOXATI N, OXALI PLATI N
EMADI NE, EMEDASTI NE DI FUMARATE
EMBEDA, MORPHI NE SULFATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 20
APPENDI X A - PRODUCT NAME I NDEX
* * E * *
EMBELI NE, CLOBETASOL PROPI ONATE
EMBELI NE E, CLOBETASOL PROPI ONATE
EMCYT, ESTRAMUSTI NE PHOSPHATE SODI UM
EMEND, APREPI TANT
EMEND, FOSAPREPI TANT DI MEGLUMI NE
EMLA, LI DOCAI NE
EMOQUETTE, DESOGESTREL
EMSAM, SELEGI LI NE
EMTRI VA, EMTRI CI TABI NE
ENABLEX, DARI FENACI N HYDROBROMI DE
ENALAPRI L MALEATE, ENALAPRI L MALEATE
ENALAPRI L MALEATE AND HYDROCHLOROTHI AZI DE, ENALAPRI L MALEATE
ENALAPRI LAT, ENALAPRI LAT
ENDOMETRI N, PROGESTERONE
ENDOSOL EXTRA, CALCI UM CHLORI DE
ENFLURANE, ENFLURANE
ENJ UVI A, ESTROGENS, CONJ UGATED SYNTHETI C B
ENLON, EDROPHONI UM CHLORI DE
ENLON- PLUS, ATROPI NE SULFATE
ENOXAPARI N SODI UM, ENOXAPARI N SODI UM
ENOXAPARI N SODI UM ( PRESERVATI VE FREE) , ENOXAPARI N SODI UM
ENPRESSE- 28, ETHI NYL ESTRADI OL
ENSKYCE, DESOGESTREL
ENTACAPONE, ENTACAPONE
ENTEREG, ALVI MOPAN
ENTOCORT EC, BUDESONI DE
ENULOSE, LACTULOSE
EOVI ST, GADOXETATE DI SODI UM
EPANED KI T, ENALAPRI L MALEATE
EPI DUO, ADAPALENE
EPI FOAM, HYDROCORTI SONE ACETATE
EPI NASTI NE HYDROCHLORI DE, EPI NASTI NE HYDROCHLORI DE
EPI PEN, EPI NEPHRI NE
EPI PEN J R. , EPI NEPHRI NE
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
EPI TOL, CARBAMAZEPI NE
EPI VI R, LAMI VUDI NE
EPI VI R- HBV, LAMI VUDI NE
EPLERENONE, EPLERENONE
EPOPROSTENOL SODI UM, EPOPROSTENOL SODI UM
EPROSARTAN MESYLATE, EPROSARTAN MESYLATE
EPZI COM, ABACAVI R SULFATE
EQUETRO, CARBAMAZEPI NE
ERAXI S, ANI DULAFUNGI N
ERGOCALCI FEROL, ERGOCALCI FEROL
ERGOLOI D MESYLATES, ERGOLOI D MESYLATES
ERGOMAR, ERGOTAMI NE TARTRATE
ERGOTAMI NE TARTRATE AND CAFFEI NE, CAFFEI NE
ERI VEDGE, VI SMODEGI B
ERRI N, NORETHI NDRONE
ERTACZO, SERTACONAZOLE NI TRATE
ERY- TAB, ERYTHROMYCI N
ERYC, ERYTHROMYCI N
ERYGEL, ERYTHROMYCI N
ERYPED, ERYTHROMYCI N ETHYLSUCCI NATE
ERYTHRA- DERM, ERYTHROMYCI N
ERYTHRO- STATI N, ERYTHROMYCI N
ERYTHROCI N, ERYTHROMYCI N LACTOBI ONATE
ERYTHROCI N STEARATE, ERYTHROMYCI N STEARATE
ERYTHROMYCI N, ERYTHROMYCI N
ERYTHROMYCI N AND BENZOYL PEROXI DE, BENZOYL PEROXI DE
ERYTHROMYCI N ETHYLSUCCI NATE, ERYTHROMYCI N ETHYLSUCCI NATE
ERYTHROMYCI N ETHYLSUCCI NATE AND SULFI SOXAZOLE ACETYL, ERYTHROMYCI N ETHYLSUCCI NATE
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
ESGI C- PLUS, ACETAMI NOPHEN



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 21
APPENDI X A - PRODUCT NAME I NDEX
* * E * *
ESMOLOL HYDROCHLORI DE, ESMOLOL HYDROCHLORI DE
ESOMEPRAZOLE SODI UM, ESOMEPRAZOLE SODI UM
ESOMEPRAZOLE STRONTI UM, ESOMEPRAZOLE STRONTI UM
ESTARYLLA, ETHI NYL ESTRADI OL
ESTAZOLAM, ESTAZOLAM
ESTRACE, ESTRADI OL
ESTRADERM, ESTRADI OL
ESTRADI OL, ESTRADI OL
ESTRADI OL AND NORETHI NDRONE ACETATE, ESTRADI OL
ESTRADI OL AND NORGESTI MATE, ESTRADI OL
ESTRADI OL CYPI ONATE, ESTRADI OL CYPI ONATE
ESTRADI OL VALERATE, ESTRADI OL VALERATE
ESTRASORB, ESTRADI OL HEMI HYDRATE
ESTRI NG, ESTRADI OL
ESTROGEL, ESTRADI OL
ESTROPI PATE, ESTROPI PATE
ESTROSTEP FE, ETHI NYL ESTRADI OL
ESZOPI CLONE, ESZOPI CLONE
ETHAMBUTOL HYDROCHLORI DE, ETHAMBUTOL HYDROCHLORI DE
ETHAMOLI N, ETHANOLAMI NE OLEATE
ETHOSUXI MI DE, ETHOSUXI MI DE
ETHRANE, ENFLURANE
ETHYOL, AMI FOSTI NE
ETI DRONATE DI SODI UM, ETI DRONATE DI SODI UM
ETODOLAC, ETODOLAC
ETOMI DATE, ETOMI DATE
ETOPOPHOS PRESERVATI VE FREE, ETOPOSI DE PHOSPHATE
ETOPOSI DE, ETOPOSI DE
EURAX, CROTAMI TON
EVAMI ST, ESTRADI OL
EVI STA, RALOXI FENE HYDROCHLORI DE
EVOCLI N, CLI NDAMYCI N PHOSPHATE
EVOXAC, CEVI MELI NE HYDROCHLORI DE
EXALGO, HYDROMORPHONE HYDROCHLORI DE
EXCEDRI N ( MI GRAI NE) , ACETAMI NOPHEN ( OTC)
EXELDERM, SULCONAZOLE NI TRATE
EXELON, RI VASTI GMI NE
EXELON, RI VASTI GMI NE TARTRATE
EXEMESTANE, EXEMESTANE
EXFORGE, AMLODI PI NE BESYLATE
EXFORGE HCT, AMLODI PI NE BESYLATE
EXI DI NE, CHLORHEXI DI NE GLUCONATE ( OTC)
EXJ ADE, DEFERASI ROX
EXPAREL, BUPI VACAI NE
EXTENDED PHENYTOI N SODI UM, PHENYTOI N SODI UM
EXTI NA, KETOCONAZOLE
EXTRANEAL, I CODEXTRI N
* * F * *
FABI OR, TAZAROTENE
FACTI VE, GEMI FLOXACI N MESYLATE
FALMI NA, ETHI NYL ESTRADI OL
FAMCI CLOVI R, FAMCI CLOVI R
FAMOTI DI NE, FAMOTI DI NE ( OTC)
FAMOTI DI NE, FAMOTI DI NE
FAMOTI DI NE PRESERVATI VE FREE, FAMOTI DI NE
FAMOTI DI NE PRESERVATI VE FREE I N PLASTI C CONTAI NER, FAMOTI DI NE
FAMVI R, FAMCI CLOVI R
FANAPT, I LOPERI DONE
FARESTON, TOREMI FENE CI TRATE
FASLODEX, FULVESTRANT
FAZACLO ODT, CLOZAPI NE
FELBAMATE, FELBAMATE
FELBATOL, FELBAMATE
FELDENE, PI ROXI CAM



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 22
APPENDI X A - PRODUCT NAME I NDEX
* * F * *
FELODI PI NE, FELODI PI NE
FEMARA, LETROZOLE
FEMCON FE, ETHI NYL ESTRADI OL
FEMHRT, ETHI NYL ESTRADI OL
FEMRI NG, ESTRADI OL ACETATE
FEMSTAT 3, BUTOCONAZOLE NI TRATE ( OTC)
FEMTRACE, ESTRADI OL ACETATE
FENOFI BRATE, FENOFI BRATE
FENOFI BRATE ( MI CRONI ZED) , FENOFI BRATE
FENOFI BRI C ACI D, CHOLI NE FENOFI BRATE
FENOGLI DE, FENOFI BRATE
FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE
FENOPROFEN CALCI UM, FENOPROFEN CALCI UM
FENTANYL CI TRATE, FENTANYL CI TRATE
FENTANYL CI TRATE PRESERVATI VE FREE, FENTANYL CI TRATE
FENTANYL- 100, FENTANYL
FENTANYL- 12, FENTANYL
FENTANYL- 25, FENTANYL
FENTANYL- 50, FENTANYL
FENTANYL- 75, FENTANYL
FENTORA, FENTANYL CI TRATE
FERAHEME, FERUMOXYTOL
FERRI PROX, DEFERI PRONE
FERRLECI T, SODI UM FERRI C GLUCONATE COMPLEX
FETZI MA, LEVOMI LNACI PRAN HYDROCHLORI DE
FEXOFENADI NE HYDROCHLORI DE, FEXOFENADI NE HYDROCHLORI DE
FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
FEXOFENADI NE HYDROCHLORI DE AND PSEUDOEPHEDRI NE HYDROCHLORI DE, FEXOFENADI NE HYDROCHLORI DE
FEXOFENADI NE HYDROCHLORI DE AND PSEUDOEPHEDRI NE HYDROCHLORI DE, FEXOFENADI NE HYDROCHLORI DE
FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
FI BRI COR, FENOFI BRI C ACI D
FI NACEA, AZELAI C ACI D
FI NASTERI DE, FI NASTERI DE
FI ORI CET, ACETAMI NOPHEN
FI ORI CET W/ CODEI NE, ACETAMI NOPHEN
FI ORI NAL, ASPI RI N
FI ORI NAL W/ CODEI NE, ASPI RI N
FI RAZYR, I CATI BANT ACETATE
FI RMAGON, DEGARELI X ACETATE
FLAGYL, METRONI DAZOLE
FLAGYL ER, METRONI DAZOLE
FLAGYL I . V. RTU I N PLASTI C CONTAI NER, METRONI DAZOLE
FLAREX, FLUOROMETHOLONE ACETATE
FLAVORED COLESTI D, COLESTI POL HYDROCHLORI DE
FLAVOXATE HYDROCHLORI DE, FLAVOXATE HYDROCHLORI DE
FLECAI NI DE ACETATE, FLECAI NI DE ACETATE
FLECTOR, DI CLOFENAC EPOLAMI NE
FLO- PRED, PREDNI SOLONE ACETATE
FLOLAN, EPOPROSTENOL SODI UM
FLOMAX, TAMSULOSI N HYDROCHLORI DE
FLONASE, FLUTI CASONE PROPI ONATE
FLOVENT DI SKUS 100, FLUTI CASONE PROPI ONATE
FLOVENT DI SKUS 250, FLUTI CASONE PROPI ONATE
FLOVENT DI SKUS 50, FLUTI CASONE PROPI ONATE
FLOVENT HFA, FLUTI CASONE PROPI ONATE
FLOXI N OTI C, OFLOXACI N
FLOXURI DI NE, FLOXURI DI NE
FLUCANAZOLE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, FLUCONAZOLE
FLUCONAZOLE, FLUCONAZOLE
FLUCONAZOLE I N DEXTROSE 5%I N PLASTI C CONTAI NER, FLUCONAZOLE
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%, FLUCONAZOLE
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, FLUCONAZOLE
FLUCYTOSI NE, FLUCYTOSI NE
FLUDARABI NE PHOSPHATE, FLUDARABI NE PHOSPHATE
FLUDEOXYGLUCOSE F- 18, FLUDEOXYGLUCOSE F- 18

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 23
APPENDI X A - PRODUCT NAME I NDEX
* * F * *
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F- 18
FLUDROCORTI SONE ACETATE, FLUDROCORTI SONE ACETATE
FLUMADI NE, RI MANTADI NE HYDROCHLORI DE
FLUMAZENI L, FLUMAZENI L
FLUNI SOLI DE, FLUNI SOLI DE
FLUOCI NOLONE ACETONI DE, FLUOCI NOLONE ACETONI DE
FLUOCI NONI DE, FLUOCI NONI DE
FLUOCI NONI DE EMULSI FI ED BASE, FLUOCI NONI DE
FLUORESCI TE, FLUORESCEI N SODI UM
FLUOROPLEX, FLUOROURACI L
FLUOROURACI L, FLUOROURACI L
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FLUOXYMESTERONE, FLUOXYMESTERONE
FLUPHENAZI NE DECANOATE, FLUPHENAZI NE DECANOATE
FLUPHENAZI NE HYDROCHLORI DE, FLUPHENAZI NE HYDROCHLORI DE
FLURAZEPAM HYDROCHLORI DE, FLURAZEPAM HYDROCHLORI DE
FLURBI PROFEN, FLURBI PROFEN
FLURBI PROFEN SODI UM, FLURBI PROFEN SODI UM
FLUTAMI DE, FLUTAMI DE
FLUTI CASONE PROPI ONATE, FLUTI CASONE PROPI ONATE
FLUVASTATI N SODI UM, FLUVASTATI N SODI UM
FLUVOXAMI NE MALEATE, FLUVOXAMI NE MALEATE
FML, FLUOROMETHOLONE
FML FORTE, FLUOROMETHOLONE
FOAMCOAT, ALUMI NUM HYDROXI DE ( OTC)
FOCALI N, DEXMETHYLPHENI DATE HYDROCHLORI DE
FOCALI N XR, DEXMETHYLPHENI DATE HYDROCHLORI DE
FOLI C ACI D, FOLI C ACI D
FOLLI STI M AQ, FOLLI TROPI N ALFA/ BETA
FOLOTYN, PRALATREXATE
FOMEPI ZOLE, FOMEPI ZOLE
FONDAPARI NUX SODI UM, FONDAPARI NUX SODI UM
FORADI L, FORMOTEROL FUMARATE
FORANE, I SOFLURANE
FORFI VO XL, BUPROPI ON HYDROCHLORI DE
FORTAMET, METFORMI N HYDROCHLORI DE
FORTAZ, CEFTAZI DI ME
FORTAZ I N PLASTI C CONTAI NER, CEFTAZI DI ME SODI UM
FORTEO, TERI PARATI DE RECOMBI NANT HUMAN
FORTESTA, TESTOSTERONE
FORTI CAL, CALCI TONI N SALMON RECOMBI NANT
FOSAMAX, ALENDRONATE SODI UM
FOSAMAX PLUS D, ALENDRONATE SODI UM
FOSCARNET SODI UM, FOSCARNET SODI UM
FOSCAVI R, FOSCARNET SODI UM
FOSI NOPRI L SODI UM, FOSI NOPRI L SODI UM
FOSI NOPRI L SODI UM AND HYDROCHLOROTHI AZI DE, FOSI NOPRI L
FOSI NOPRI L SODI UM AND HYDROCHLOROTHI AZI DE, FOSI NOPRI L SODI UM
FOSPHENYTOI N SODI UM, FOSPHENYTOI N SODI UM
FOSRENOL, LANTHANUM CARBONATE
FRAGMI N, DALTEPARI N SODI UM
FREAMI NE HBC 6. 9%, AMI NO ACI DS
FREAMI NE I I I 10%, AMI NO ACI DS
FREAMI NE I I I 3%W/ ELECTROLYTES, AMI NO ACI DS
FREAMI NE I I I 8. 5%, AMI NO ACI DS
FREAMI NE I I I 8. 5%W/ ELECTROLYTES, AMI NO ACI DS
FROVA, FROVATRI PTAN SUCCI NATE
FULYZAQ, CROFELEMER
FURADANTI N, NI TROFURANTOI N
FUROSEMI DE, FUROSEMI DE
FUSI LEV, LEVOLEUCOVORI N CALCI UM
FUZEON, ENFUVI RTI DE
FYCOMPA, PERAMPANEL
* * G * *


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 24
APPENDI X A - PRODUCT NAME I NDEX
* * G * *
GABAPENTI N, GABAPENTI N
GABI TRI L, TI AGABI NE HYDROCHLORI DE
GABLOFEN, BACLOFEN
GADAVI ST, GADOBUTROL
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
GALLI UM CI TRATE GA 67, GALLI UM CI TRATE GA- 67
GALZI N, ZI NC ACETATE
GANCI CLOVI R, GANCI CLOVI R SODI UM
GANI RELI X ACETATE, GANI RELI X ACETATE
GASTROCROM, CROMOLYN SODI UM
GASTROGRAFI N, DI ATRI ZOATE MEGLUMI NE
GATI FLOXACI N, GATI FLOXACI N
GATTEX KI T, TEDUGLUTI DE RECOMBI NANT
GAVI SCON, ALUMI NUM HYDROXI DE ( OTC)
GELNI QUE, OXYBUTYNI N CHLORI DE
GELNI QUE 3%, OXYBUTYNI N
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
GEMFI BROZI L, GEMFI BROZI L
GEMZAR, GEMCI TABI NE HYDROCHLORI DE
GEN- XENE, CLORAZEPATE DI POTASSI UM
GENERLAC, LACTULOSE
GENGRAF, CYCLOSPORI NE
GENOPTI C, GENTAMI CI N SULFATE
GENOTROPI N, SOMATROPI N RECOMBI NANT
GENOTROPI N PRESERVATI VE FREE, SOMATROPI N RECOMBI NANT
GENTAK, GENTAMI CI N SULFATE
GENTAMI CI N SULFATE, GENTAMI CI N SULFATE
GENTAMI CI N SULFATE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, GENTAMI CI N SULFATE
GEODON, ZI PRASI DONE HYDROCHLORI DE
GEODON, ZI PRASI DONE MESYLATE
GI AZO, BALSALAZI DE DI SODI UM
GI LDAGI A, ETHI NYL ESTRADI OL
GI LDESS FE 1. 5/ 30, ETHI NYL ESTRADI OL
GI LDESS FE 1/ 20, ETHI NYL ESTRADI OL
GI LENYA, FI NGOLI MOD
GI LOTRI F, AFATI NI B DI MALEATE
GLEEVEC, I MATI NI B MESYLATE
GLI ADEL, CARMUSTI NE
GLI MEPI RI DE, GLI MEPI RI DE
GLI PI ZI DE, GLI PI ZI DE
GLI PI ZI DE AND METFORMI N HYDROCHLORI DE, GLI PI ZI DE
GLOFI L- 125, I OTHALAMATE SODI UM I - 125
GLUCAGEN, GLUCAGON HYDROCHLORI DE RECOMBI NANT
GLUCAGON, GLUCAGON RECOMBI NANT
GLUCOPHAGE, METFORMI N HYDROCHLORI DE
GLUCOPHAGE XR, METFORMI N HYDROCHLORI DE
GLUCOTROL, GLI PI ZI DE
GLUCOTROL XL, GLI PI ZI DE
GLUCOVANCE, GLYBURI DE
GLUMETZA, METFORMI N HYDROCHLORI DE
GLYBURI DE, GLYBURI DE
GLYBURI DE ( MI CRONI ZED) , GLYBURI DE
GLYBURI DE AND METFORMI N HYDROCHLORI DE, GLYBURI DE
GLYCI NE 1. 5%I N PLASTI C CONTAI NER, GLYCI NE
GLYCOLAX, POLYETHYLENE GLYCOL 3350 ( OTC)
GLYCOLAX, POLYETHYLENE GLYCOL 3350
GLYCOPYRROLATE, GLYCOPYRROLATE
GLYNASE, GLYBURI DE
GLYSET, MI GLI TOL
GOLYTELY, POLYETHYLENE GLYCOL 3350
GONAL- F, FOLLI TROPI N ALFA/ BETA
GONAL- F RFF, FOLLI TROPI N ALFA/ BETA
GONAL- F RFF PEN, FOLLI TROPI N ALFA/ BETA
GRALI SE, GABAPENTI N
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE








34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 25
APPENDI X A - PRODUCT NAME I NDEX
* * G * *
GRANI SETRON HYDROCHLORI DE PRESERVATI VE FREE, GRANI SETRON HYDROCHLORI DE
GRANI STERON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
GRI FULVI N V, GRI SEOFULVI N, MI CROSI ZE
GRI S- PEG, GRI SEOFULVI N, ULTRAMI CROSI ZE
GRI SEOFULVI N, GRI SEOFULVI N, MI CROSI ZE
GRI SEOFULVI N, ULTRAMI CROSI ZE, GRI SEOFULVI N, ULTRAMI CROSI ZE
GRI SEOFULVI N, ULTRAMI CROSI ZE, GRI SEOFULVI N, ULTRAMI CROSI ZE
GUAI FENESI N, GUAI FENESI N ( OTC)
GUANABENZ ACETATE, GUANABENZ ACETATE
GUANFACI NE HYDROCHLORI DE, GUANFACI NE HYDROCHLORI DE
GUANI DI NE HYDROCHLORI DE, GUANI DI NE HYDROCHLORI DE
GYNE- LOTRI MI N, CLOTRI MAZOLE ( OTC)
GYNE- LOTRI MI N 3, CLOTRI MAZOLE ( OTC)
GYNE- LOTRI MI N 3 COMBI NATI ON PACK, CLOTRI MAZOLE ( OTC)
GYNE- LOTRI MI N COMBI NATI ON PACK, CLOTRI MAZOLE ( OTC)
* * H * *
H. P. ACTHAR GEL, CORTI COTROPI N
HABI TROL, NI COTI NE ( OTC)
HALAVEN, ERI BULI N MESYLATE
HALCI ON, TRI AZOLAM
HALDOL, HALOPERI DOL DECANOATE
HALDOL, HALOPERI DOL LACTATE
HALFLYTELY, BI SACODYL
HALOBETASOL PROPI ONATE, HALOBETASOL PROPI ONATE
HALOG, HALCI NONI DE
HALOPERI DOL, HALOPERI DOL
HALOPERI DOL, HALOPERI DOL LACTATE
HALOPERI DOL DECANOATE, HALOPERI DOL DECANOATE
HEATHER, NORETHI NDRONE
HECTOROL, DOXERCALCI FEROL
HELI DAC, BI SMUTH SUBSALI CYLATE
HEMABATE, CARBOPROST TROMETHAMI NE
HEPARI N SODI UM, HEPARI N SODI UM
HEPARI N SODI UM 1, 000 UNI TS AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 1, 000 UNI TS I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 10, 000 UNI TS I N DEXTROSE 5%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 12, 500 UNI TS I N DEXTROSE 5%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 12, 500 UNI TS I N SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 2, 000 UNI TS AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 2, 000 UNI TS I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 20, 000 UNI TS I N DEXTROSE 5%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 25, 000 UNI TS I N DEXTROSE 5%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 25, 000 UNI TS I N SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM PRESERVATI VE FREE, HEPARI N SODI UM
HEPATAMI NE 8%, AMI NO ACI DS
HEPATASOL 8%, AMI NO ACI DS
HEPATOLI TE, TECHNETI UM TC- 99M DI SOFENI N KI T
HEPSERA, ADEFOVI R DI PI VOXI L
HERPLEX, I DOXURI DI NE
HEXABRI X, I OXAGLATE MEGLUMI NE
HEXALEN, ALTRETAMI NE
HI BI CLENS, CHLORHEXI DI NE GLUCONATE ( OTC)
HI BI STAT, CHLORHEXI DI NE GLUCONATE ( OTC)
HI CON, SODI UM I ODI DE I - 131
HI PREX, METHENAMI NE HI PPURATE
HOMATROPI NE METHYLBROMI DE AND HYDROCODONE BI TARTRATE, HOMATROPI NE METHYLBROMI DE
HORI ZANT, GABAPENTI N ENACARBI L
HUMALOG, I NSULI N LI SPRO RECOMBI NANT
HUMALOG KWI KPEN, I NSULI N LI SPRO RECOMBI NANT
HUMALOG MI X 50/ 50, I NSULI N LI SPRO PROTAMI NE RECOMBI NANT
HUMALOG MI X 50/ 50 KWI KPEN, I NSULI N LI SPRO PROTAMI NE RECOMBI NANT
HUMALOG MI X 75/ 25, I NSULI N LI SPRO PROTAMI NE RECOMBI NANT
HUMALOG MI X 75/ 25 KWI KPEN, I NSULI N LI SPRO PROTAMI NE RECOMBI NANT












34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 26
APPENDI X A - PRODUCT NAME I NDEX
* * H * *
HUMATROPE, SOMATROPI N RECOMBI NANT
HUMULI N 70/ 30, I NSULI N RECOMBI NANT HUMAN ( OTC)
HUMULI N 70/ 30 PEN, I NSULI N RECOMBI NANT HUMAN ( OTC)
HUMULI N N, I NSULI N SUSP I SOPHANE RECOMBI NANT HUMAN ( OTC)
HUMULI N R, I NSULI N RECOMBI NANT HUMAN ( OTC)
HUMULI N R, I NSULI N RECOMBI NANT HUMAN
HUMULI N R PEN, I NSULI N RECOMBI NANT HUMAN ( OTC)
HYCAMTI N, TOPOTECAN HYDROCHLORI DE
HYDERGI NE, ERGOLOI D MESYLATES
HYDRA- ZI DE, HYDRALAZI NE HYDROCHLORI DE
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
HYDREA, HYDROXYUREA
HYDRO- RX, HYDROCORTI SONE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
HYDROCODONE BI TARTRATE AND HOMATROPI NE METHYLBROMI DE, HOMATROPI NE METHYLBROMI DE
HYDROCODONE BI TARTRATE AND I BUPROFEN, HYDROCODONE BI TARTRATE
HYDROCODONE POLI STI REX AND CHLORPHENI RAMI NE POLI STI REX, CHLORPHENI RAMI NE POLI STI REX
HYDROCODONE POLI STI REX AND CHLORPHENI RAMNE POLI STI REX, CHLORPHENI RAMI NE POLI STI REX
HYDROCORTI SONE, HYDROCORTI SONE
HYDROCORTI SONE ACETATE, HYDROCORTI SONE ACETATE
HYDROCORTI SONE AND ACETI C ACI D, ACETI C ACI D, GLACI AL
HYDROCORTI SONE BUTYRATE, HYDROCORTI SONE BUTYRATE
HYDROCORTI SONE I N ABSORBASE, HYDROCORTI SONE
HYDROCORTI SONE VALERATE, HYDROCORTI SONE VALERATE
HYDROMORPHONE HYDROCHLORI DE, HYDROMORPHONE HYDROCHLORI DE
HYDROXOCOBALAMI N, HYDROXOCOBALAMI N
HYDROXYCHLOROQUI NE SULFATE, HYDROXYCHLOROQUI NE SULFATE
HYDROXYUREA, HYDROXYUREA
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
HYDROXYZI NE PAMOATE, HYDROXYZI NE PAMOATE
HYLENEX RECOMBI NANT, HYALURONI DASE RECOMBI NANT HUMAN
HYTRI N, TERAZOSI N HYDROCHLORI DE
HYZAAR, HYDROCHLOROTHI AZI DE
* * I * *
I BANDRONATE SODI UM, I BANDRONATE SODI UM
I BU- TAB, I BUPROFEN
I BU- TAB 200, I BUPROFEN ( OTC)
I BUPROFEN, I BUPROFEN ( OTC)
I BUPROFEN, I BUPROFEN
I BUPROFEN AND DI PHENHYDRAMI NE CI TRATE, DI PHENHYDRAMI NE CI TRATE ( OTC)
I BUPROFEN AND DI PHENHYDRAMI NE HYDROCHLORI DE, DI PHENHYDRAMI NE HYDROCHLORI DE ( OTC)
I BUPROFEN AND PSEUDOEPHEDRI NE HYDROCHLORI DE, I BUPROFEN ( OTC)
I BUPROHM, I BUPROFEN ( OTC)
I BUPROHM COLD AND SI NUS, I BUPROFEN ( OTC)
I BUTI LI DE FUMARATE, I BUTI LI DE FUMARATE
I C- GREEN, I NDOCYANI NE GREEN
I CLUSI G, PONATI NI B HYDROCHLORI DE
I DAMYCI N PFS, I DARUBI CI N HYDROCHLORI DE
I DARUBI CI N HYDROCHLORI DE, I DARUBI CI N HYDROCHLORI DE
I DARUBI CI N HYDROCHLORI DE PFS, I DARUBI CI N HYDROCHLORI DE
I DKI T: HP, CI TRI C ACI D
I FEX, I FOSFAMI DE
I FOSFAMI DE, I FOSFAMI DE
I FOSFAMI DE/ MESNA KI T, I FOSFAMI DE
I LEVRO, NEPAFENAC
I MBRUVI CA, I BRUTI NI B
I MI PENEM AND CI LASTATI N, CI LASTATI N SODI UM
I MI PRAMI NE HYDROCHLORI DE, I MI PRAMI NE HYDROCHLORI DE
I MI PRAMI NE PAMOATE, I MI PRAMI NE PAMOATE
I MI QUI MOD, I MI QUI MOD
I MI TREX, SUMATRI PTAN
I MI TREX, SUMATRI PTAN SUCCI NATE
I MI TREX STATDOSE, SUMATRI PTAN SUCCI NATE





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 27
APPENDI X A - PRODUCT NAME I NDEX
* * I * *
I MODI UM, LOPERAMI DE HYDROCHLORI DE
I MODI UM A- D, LOPERAMI DE HYDROCHLORI DE ( OTC)
I MODI UM A- D EZ CHEWS, LOPERAMI DE HYDROCHLORI DE ( OTC)
I MODI UM MULTI - SYMPTOM RELI EF, LOPERAMI DE HYDROCHLORI DE ( OTC)
I MPLANON, ETONOGESTREL
I MURAN, AZATHI OPRI NE
I NAPSI NE, DROPERI DOL
I NCI VEK, TELAPREVI R
I NCRELEX, MECASERMI N RECOMBI NANT
I NDAPAMI DE, I NDAPAMI DE
I NDERAL, PROPRANOLOL HYDROCHLORI DE
I NDERAL LA, PROPRANOLOL HYDROCHLORI DE
I NDERI DE- 40/ 25, HYDROCHLOROTHI AZI DE
I NDI CLOR, I NDI UM I N- 111 CHLORI DE
I NDI UM I N 111 CHLORI DE, I NDI UM I N- 111 CHLORI DE
I NDI UM I N- 111 OXYQUI NOLI NE, I NDI UM I N- 111 OXYQUI NOLI NE
I NDOCI N, I NDOMETHACI N
I NDOCI N, I NDOMETHACI N SODI UM
I NDOCYANI NE GREEN, I NDOCYANI NE GREEN
I NDOMETHACI N, I NDOMETHACI N
I NDOMETHACI N SODI UM, I NDOMETHACI N SODI UM
I NFANTS' FEVERALL, ACETAMI NOPHEN ( OTC)
I NFASURF PRESERVATI VE FREE, CALFACTANT
I NFED, I RON DEXTRAN
I NFUMORPH, MORPHI NE SULFATE
I NFUVI TE ADULT, ALPHA- TOCOPHEROL ACETATE
I NFUVI TE PEDI ATRI C, ASCORBI C ACI D
I NFUVI TE PEDI ATRI C ( PHARMACY BULK PACKAGE) , ASCORBI C ACI D
I NJ ECTAFER, FERRI C CARBOXYMALTOSE
I NLYTA, AXI TI NI B
I NNOPRAN XL, PROPRANOLOL HYDROCHLORI DE
I NOMAX, NI TRI C OXI DE
I NSPRA, EPLERENONE
I NTEGRI LI N, EPTI FI BATI DE
I NTELENCE, ETRAVI RI NE
I NTERMEZZO, ZOLPI DEM TARTRATE
I NTRALI PI D 10%, SOYBEAN OI L
I NTRALI PI D 20%, SOYBEAN OI L
I NTRALI PI D 30%, SOYBEAN OI L
I NTROVALE, ETHI NYL ESTRADI OL
I NTUNI V, GUANFACI NE HYDROCHLORI DE
I NVANZ, ERTAPENEM SODI UM
I NVEGA, PALI PERI DONE
I NVEGA SUSTENNA, PALI PERI DONE PALMI TATE
I NVI RASE, SAQUI NAVI R MESYLATE
I NVOKANA, CANAGLI FLOZI N
I ONOSOL B AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
I ONOSOL MB AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
I OPAMI DOL- 250, I OPAMI DOL
I OPAMI DOL- 300, I OPAMI DOL
I OPAMI DOL- 370, I OPAMI DOL
I OPI DI NE, APRACLONI DI NE HYDROCHLORI DE
I OSAT, POTASSI UM I ODI DE ( OTC)
I PRATROPI UM BROMI DE, I PRATROPI UM BROMI DE
I PRI VASK, DESI RUDI N RECOMBI NANT
I QUI X, LEVOFLOXACI N
I RBESARTAN, I RBESARTAN
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
I SENTRESS, RALTEGRAVI R POTASSI UM
I SOCAI NE HYDROCHLORI DE, MEPI VACAI NE HYDROCHLORI DE
I SOFLURANE, I SOFLURANE
I SOLYTE E I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
I SOLYTE H I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
I SOLYTE M I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 28
APPENDI X A - PRODUCT NAME I NDEX
* * I * *
I SOLYTE P I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
I SOLYTE R I N DEXTROSE 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
I SOLYTE S I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
I SOLYTE S I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
I SOLYTE S PH 7. 4 I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
I SONI AZI D, I SONI AZI D
I SOPTO CARPI NE, PI LOCARPI NE HYDROCHLORI DE
I SORDI L, I SOSORBI DE DI NI TRATE
I SOSORBI DE DI NI TRATE, I SOSORBI DE DI NI TRATE
I SOSORBI DE MONONI TRATE, I SOSORBI DE MONONI TRATE
I SOSULFAN BLUE, I SOSULFAN BLUE
I SOTONI C GENTAMI CI N SULFATE I N PLASTI C CONTAI NER, GENTAMI CI N SULFATE
I SOVUE- 200, I OPAMI DOL
I SOVUE- 250, I OPAMI DOL
I SOVUE- 300, I OPAMI DOL
I SOVUE- 370, I OPAMI DOL
I SOVUE- M 200, I OPAMI DOL
I SOVUE- M 300, I OPAMI DOL
I SRADI PI NE, I SRADI PI NE
I STALOL, TI MOLOL MALEATE
I STODAX, ROMI DEPSI N
I SUPREL, I SOPROTERENOL HYDROCHLORI DE
I TRACONAZOLE, I TRACONAZOLE
I VY BLOCK, BENTOQUATAM ( OTC)
I XEMPRA KI T, I XABEPI LONE
* * J * *
J AKAFI , RUXOLI TI NI B PHOSPHATE
J ALYN, DUTASTERI DE
J ANTOVEN, WARFARI N SODI UM
J ANUMET, METFORMI N HYDROCHLORI DE
J ANUMET XR, METFORMI N HYDROCHLORI DE
J ANUVI A, SI TAGLI PTI N PHOSPHATE
J EANATOPE, ALBUMI N I ODI NATED I - 125 SERUM
J ENCYCLA, NORETHI NDRONE
J ENTADUETO, LI NAGLI PTI N
J EVTANA KI T, CABAZI TAXEL
J UNEL 1. 5/ 30, ETHI NYL ESTRADI OL
J UNEL 1/ 20, ETHI NYL ESTRADI OL
J UNEL FE 1. 5/ 30, ETHI NYL ESTRADI OL
J UNEL FE 1/ 20, ETHI NYL ESTRADI OL
J UNI OR STRENGTH ADVI L, I BUPROFEN ( OTC)
J UNI OR STRENGTH I BUPROFEN, I BUPROFEN ( OTC)
J UNI OR STRENGTH MOTRI N, I BUPROFEN ( OTC)
J UXTAPI D, LOMI TAPI DE MESYLATE
* * K * *
K- TAB, POTASSI UM CHLORI DE
KADI AN, MORPHI NE SULFATE
KALETRA, LOPI NAVI R
KALEXATE, SODI UM POLYSTYRENE SULFONATE
KALYDECO, I VACAFTOR
KANAMYCI N SULFATE, KANAMYCI N SULFATE
KAPVAY, CLONI DI NE HYDROCHLORI DE
KARBI NAL ER, CARBI NOXAMI NE MALEATE
KARI VA, DESOGESTREL
KAYEXALATE, SODI UM POLYSTYRENE SULFONATE
KAZANO, ALOGLI PTI N BENZOATE
KEFLEX, CEPHALEXI N
KEFZOL, CEFAZOLI N SODI UM
KELNOR, ETHI NYL ESTRADI OL
KENALOG, TRI AMCI NOLONE ACETONI DE
KENALOG- 10, TRI AMCI NOLONE ACETONI DE
KENALOG- 40, TRI AMCI NOLONE ACETONI DE
KEPPRA, LEVETI RACETAM





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 29
APPENDI X A - PRODUCT NAME I NDEX
* * K * *
KEPPRA XR, LEVETI RACETAM
KETALAR, KETAMI NE HYDROCHLORI DE
KETAMI NE HYDROCHLORI DE, KETAMI NE HYDROCHLORI DE
KETEK, TELI THROMYCI N
KETOCONAZOLE, KETOCONAZOLE
KETOPROFEN, KETOPROFEN
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
KETOTI FEN FUMARATE, KETOTI FEN FUMARATE ( OTC)
KETOZOLE, KETOCONAZOLE
KHEDEZLA, DESVENLAFAXI NE
KI NEVAC, SI NCALI DE
KI ONEX, SODI UM POLYSTYRENE SULFONATE
KLARON, SULFACETAMI DE SODI UM
KLONOPI N, CLONAZEPAM
KLOR- CON, POTASSI UM CHLORI DE
KLOR- CON M10, POTASSI UM CHLORI DE
KLOR- CON M15, POTASSI UM CHLORI DE
KLOR- CON M20, POTASSI UM CHLORI DE
KOMBI GLYZE XR, METFORMI N HYDROCHLORI DE
KORLYM, MI FEPRI STONE
KURVELO, ETHI NYL ESTRADI OL
KUVAN, SAPROPTERI N DI HYDROCHLORI DE
KYNAMRO, MI POMERSEN SODI UM
KYPROLI S, CARFI LZOMI B
* * L * *
LABETALOL HYDROCHLORI DE, LABETALOL HYDROCHLORI DE
LABETALOL HYDROCLORI DE, LABETALOL HYDROCHLORI DE
LAC- HYDRI N, AMMONI UM LACTATE
LACRI SERT, HYDROXYPROPYL CELLULOSE
LACTATED RI NGER' S AND DEXTROSE 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
LACTATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
LACTULOSE, LACTULOSE
LAMI CTAL, LAMOTRI GI NE
LAMI CTAL CD, LAMOTRI GI NE
LAMI CTAL ODT, LAMOTRI GI NE
LAMI CTAL XR, LAMOTRI GI NE
LAMI SI L, TERBI NAFI NE HYDROCHLORI DE ( OTC)
LAMI SI L, TERBI NAFI NE HYDROCHLORI DE
LAMI SI L AT, TERBI NAFI NE ( OTC)
LAMI SI L AT, TERBI NAFI NE HYDROCHLORI DE ( OTC)
LAMI VUDI NE, LAMI VUDI NE
LAMI VUDI NE AND ZI DOVUDI NE, LAMI VUDI NE
LAMOTRI GI NE, LAMOTRI GI NE
LAMPRENE, CLOFAZI MI NE
LANI AZI D, I SONI AZI D
LANORI NAL, ASPI RI N
LANOXI N, DI GOXI N
LANOXI N PEDI ATRI C, DI GOXI N
LANSOPRAZOLE, LANSOPRAZOLE ( OTC)
LANSOPRAZOLE, LANSOPRAZOLE
LANSOPRAZOLE , LANSOPRAZOLE
LANSOPRAZOLE, AMOXI CI LLI N AND CLARI THROMYCI N, AMOXI CI LLI N
LANTUS, I NSULI N GLARGI NE RECOMBI NANT
LANTUS SOLOSTAR, I NSULI N GLARGI NE RECOMBI NANT
LARI N 1/ 20, ETHI NYL ESTRADI OL
LARI N FE 1. 5/ 30, ETHI NYL ESTRADI OL
LARI N FE 1/ 20, ETHI NYL ESTRADI OL
LAROTI D, AMOXI CI LLI N
LARYNG- O- J ET KI T, LI DOCAI NE HYDROCHLORI DE
LASI X, FUROSEMI DE
LASTACAFT, ALCAFTADI NE
LATANOPROST, LATANOPROST
LATI SSE, BI MATOPROST
LATUDA, LURASI DONE HYDROCHLORI DE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 30
APPENDI X A - PRODUCT NAME I NDEX
* * L * *
LAX- LYTE WI TH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
LAZANDA, FENTANYL CI TRATE
LEFLUNOMI DE, LEFLUNOMI DE
LESCOL, FLUVASTATI N SODI UM
LESCOL XL, FLUVASTATI N SODI UM
LESSI NA- 28, ETHI NYL ESTRADI OL
LETAI RI S, AMBRI SENTAN
LETROZOLE, LETROZOLE
LEUCOVORI N CALCI UM, LEUCOVORI N CALCI UM
LEUCOVORI N CALCI UM PRESERVATI VE FREE, LEUCOVORI N CALCI UM
LEUKERAN, CHLORAMBUCI L
LEUPROLI DE ACETATE, LEUPROLI DE ACETATE
LEVALBUTEROL HYDROCHLORI DE, LEVALBUTEROL HYDROCHLORI DE
LEVAQUI N, LEVOFLOXACI N
LEVAQUI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, LEVOFLOXACI N
LEVATOL, PENBUTOLOL SULFATE
LEVEMI R, I NSULI N DETEMI R RECOMBI NANT
LEVEMI R FLEXPEN, I NSULI N DETEMI R RECOMBI NANT
LEVETI RACETAM, LEVETI RACETAM
LEVETI RACETAM I N SODI UM CHLORI DE, LEVETI RACETAM
LEVI TRA, VARDENAFI L HYDROCHLORI DE
LEVO- T, LEVOTHYROXI NE SODI UM **
LEVOBUNOLOL HYDROCHLORI DE, LEVOBUNOLOL HYDROCHLORI DE
LEVOCARNI TI NE, LEVOCARNI TI NE
LEVOCETI RI ZI NE DI HYDROCHLORI DE, LEVOCETI RI ZI NE DI HYDROCHLORI DE
LEVOFLOXACI N, LEVOFLOXACI N
LEVOFLOXACI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, LEVOFLOXACI N
LEVONEST, ETHI NYL ESTRADI OL
LEVONORGESTREL, LEVONORGESTREL ( OTC)
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
LEVONORGESTREL AND ETHI NYL ESTRADI OL AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
LEVOPHED, NOREPI NEPHRI NE BI TARTRATE
LEVORA 0. 15/ 30- 28, ETHI NYL ESTRADI OL
LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE
LEVOTHROI D, LEVOTHYROXI NE SODI UM **
LEVOTHYROXI NE SODI UM, LEVOTHYROXI NE SODI UM
LEVOTHYROXI NE SODI UM, LEVOTHYROXI NE SODI UM **
LEVOXYL, LEVOTHYROXI NE SODI UM **
LEVULAN, AMI NOLEVULI NI C ACI D HYDROCHLORI DE
LEXAPRO, ESCI TALOPRAM OXALATE
LEXI SCAN, REGADENOSON
LEXI VA, FOSAMPRENAVI R CALCI UM
LI ALDA, MESALAMI NE
LI BRI UM, CHLORDI AZEPOXI DE HYDROCHLORI DE
LI DOCAI NE, LI DOCAI NE
LI DOCAI NE AND PRI LOCAI NE, LI DOCAI NE
LI DOCAI NE HYDROCHLORI DE, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE 0. 2%AND DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE 0. 4%AND DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE 0. 4%I N DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE 0. 8%AND DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE 0. 8%I N DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE 5%AND DEXTROSE 7. 5%, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE AND EPI NEPHRI NE, EPI NEPHRI NE
LI DOCAI NE HYDROCHLORI DE I N PLASTI C CONTAI NER, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE PRESERVATI VE FREE, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE PRESERVATI VE FREE I N PLASTI C CONTAI NER, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE VI SCOUS, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE VI SCOUS, LI DOCAI NE HYDROCHLORI DE
LI DODERM, LI DOCAI NE
LI DOPEN, LI DOCAI NE HYDROCHLORI DE
LI GNOSPAN FORTE, EPI NEPHRI NE BI TARTRATE
LI GNOSPAN STANDARD, EPI NEPHRI NE BI TARTRATE
LI NCOCI N, LI NCOMYCI N HYDROCHLORI DE






34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 31
APPENDI X A - PRODUCT NAME I NDEX
* * L * *
LI NDANE, LI NDANE
LI NEZOLI D, LI NEZOLI D
LI NZESS, LI NACLOTI DE
LI ORESAL, BACLOFEN
LI OTHYRONI NE SODI UM, LI OTHYRONI NE SODI UM
LI PI TOR, ATORVASTATI N CALCI UM
LI POFEN, FENOFI BRATE
LI POSYN I I 10%, SAFFLOWER OI L
LI POSYN I I 20%, SAFFLOWER OI L
LI POSYN I I I 10%, SOYBEAN OI L
LI POSYN I I I 20%, SOYBEAN OI L
LI POSYN I I I 30%, SOYBEAN OI L
LI PTRUZET, ATORVASTATI N CALCI UM
LI SI NOPRI L, LI SI NOPRI L
LI SI NOPRI L AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LI THI UM CARBONATE, LI THI UM CARBONATE
LI THI UM CI TRATE, LI THI UM CI TRATE
LI THOBI D, LI THI UM CARBONATE
LI THOSTAT, ACETOHYDROXAMI C ACI D
LI VALO, PI TAVASTATI N CALCI UM
LO LOESTRI N FE, ETHI NYL ESTRADI OL
LO MI NASTRI N FE, ETHI NYL ESTRADI OL
LO/ OVRAL- 28, ETHI NYL ESTRADI OL
LOCOI D, HYDROCORTI SONE BUTYRATE
LOCOI D LI POCREAM, HYDROCORTI SONE BUTYRATE
LODOSYN, CARBI DOPA
LOESTRI N 21 1. 5/ 30, ETHI NYL ESTRADI OL
LOESTRI N 21 1/ 20, ETHI NYL ESTRADI OL
LOESTRI N 24 FE, ETHI NYL ESTRADI OL
LOESTRI N FE 1. 5/ 30, ETHI NYL ESTRADI OL
LOESTRI N FE 1/ 20, ETHI NYL ESTRADI OL
LOMOTI L, ATROPI NE SULFATE
LONOX, ATROPI NE SULFATE
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE ( OTC)
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE
LOPERAMI DE HYDROCHLORI DE AND SI METHI CONE, LOPERAMI DE HYDROCHLORI DE ( OTC)
LOPI D, GEMFI BROZI L
LOPRESSOR, METOPROLOL TARTRATE
LOPRESSOR HCT, HYDROCHLOROTHI AZI DE
LOPROX, CI CLOPI ROX
LOPURI N, ALLOPURI NOL
LORATADI NE, LORATADI NE ( OTC)
LORATADI NE AND PSEUDOEPHEDRI NE SULFATE, LORATADI NE ( OTC)
LORATADI NE REDI DOSE, LORATADI NE ( OTC)
LORAZEPAM, LORAZEPAM
LORAZEPAM I NTENSOL, LORAZEPAM
LORAZEPAM PRESERVATI VE FREE, LORAZEPAM
LORTAB, ACETAMI NOPHEN
LORYNA, DROSPI RENONE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSEASONI QUE, ETHI NYL ESTRADI OL
LOTEMAX, LOTEPREDNOL ETABONATE
LOTENSI N, BENAZEPRI L HYDROCHLORI DE
LOTENSI N HCT, BENAZEPRI L HYDROCHLORI DE
LOTREL, AMLODI PI NE BESYLATE
LOTRI MI N ULTRA, BUTENAFI NE HYDROCHLORI DE ( OTC)
LOTRI SONE, BETAMETHASONE DI PROPI ONATE
LOTRONEX, ALOSETRON HYDROCHLORI DE
LOVASTATI N, LOVASTATI N
LOVAZA, OMEGA- 3- ACI D ETHYL ESTERS
LOVENOX, ENOXAPARI N SODI UM
LOVENOX ( PRESERVATI VE FREE) , ENOXAPARI N SODI UM
LOW- OGESTREL- 21, ETHI NYL ESTRADI OL
LOW- OGESTREL- 28, ETHI NYL ESTRADI OL

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 32
APPENDI X A - PRODUCT NAME I NDEX
* * L * *
LOXAPI NE SUCCI NATE, LOXAPI NE SUCCI NATE
LTA I I KI T, LI DOCAI NE HYDROCHLORI DE
LUFYLLI N, DYPHYLLI NE
LUMI GAN, BI MATOPROST
LUNESTA, ESZOPI CLONE
LUPANETA PACK, LEUPROLI DE ACETATE
LUPRON DEPOT, LEUPROLI DE ACETATE
LUPRON DEPOT- PED, LEUPROLI DE ACETATE
LUVOX, FLUVOXAMI NE MALEATE
LUVOX CR, FLUVOXAMI NE MALEATE
LUXI Q, BETAMETHASONE VALERATE
LUZU, LULI CONAZOLE
LYMPHAZURI N, I SOSULFAN BLUE
LYMPHOSEEK KI T, TECHNETI UM TC- 99M TI LMANOCEPT
LYRI CA, PREGABALI N
LYSODREN, MI TOTANE
LYSTEDA, TRANEXAMI C ACI D
* * M * *
M- ZOLE 3 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
M. V. I . ADULT, ASCORBI C ACI D
M. V. I . ADULT ( PHARMACY BULK PACKAGE) , ASCORBI C ACI D
M. V. I . PEDI ATRI C, ASCORBI C ACI D
M. V. I . - 12 ( WI THOUT VI TAMI N K) , ASCORBI C ACI D
MACROBI D, NI TROFURANTOI N
MACRODANTI N, NI TROFURANTOI N, MACROCRYSTALLI NE
MACUGEN, PEGAPTANI B SODI UM
MAFENI DE ACETATE, MAFENI DE ACETATE
MAGNESI UM SULFATE, MAGNESI UM SULFATE
MAGNESI UM SULFATE I N DEXTROSE 5%I N PLASTI C CONTAI NER, MAGNESI UM SULFATE
MAGNESI UM SULFATE I N PLASTI C CONTAI NER, MAGNESI UM SULFATE
MAGNEVI ST, GADOPENTETATE DI MEGLUMI NE
MAKENA, HYDROXYPROGESTERONE CAPROATE
MALARONE, ATOVAQUONE
MALARONE PEDI ATRI C, ATOVAQUONE
MALATHI ON, MALATHI ON
MANGANESE CHLORI DE I N PLASTI C CONTAI NER, MANGANESE CHLORI DE
MANNI TOL 10%, MANNI TOL
MANNI TOL 10%I N PLASTI C CONTAI NER, MANNI TOL
MANNI TOL 10%W/ DEXTROSE 5%I N DI STI LLED WATER, MANNI TOL
MANNI TOL 15%, MANNI TOL
MANNI TOL 15%I N PLASTI C CONTAI NER, MANNI TOL
MANNI TOL 15%W/ DEXTROSE 5%I N SODI UM CHLORI DE 0. 45%, MANNI TOL
MANNI TOL 20%, MANNI TOL
MANNI TOL 20%I N PLASTI C CONTAI NER, MANNI TOL
MANNI TOL 25%, MANNI TOL
MANNI TOL 5%, MANNI TOL
MANNI TOL 5%I N PLASTI C CONTAI NER, MANNI TOL
MANNI TOL 5%W/ DEXTROSE 5%I N SODI UM CHLORI DE 0. 12%, MANNI TOL
MAPROTI LI NE HYDROCHLORI DE, MAPROTI LI NE HYDROCHLORI DE
MARCAI NE, BUPI VACAI NE HYDROCHLORI DE
MARCAI NE HYDROCHLORI DE, BUPI VACAI NE HYDROCHLORI DE
MARCAI NE HYDROCHLORI DE PRESERVATI VE FREE, BUPI VACAI NE HYDROCHLORI DE
MARCAI NE HYDROCHLORI DE W/ EPI NEPHRI NE, BUPI VACAI NE HYDROCHLORI DE
MARCAI NE HYDROCHLORI DE W/ EPI NEPHRI NE PRESERVATI VE FREE, BUPI VACAI NE HYDROCHLORI DE
MARI NOL, DRONABI NOL
MARLI SSA, ETHI NYL ESTRADI OL
MARPLAN, I SOCARBOXAZI D
MARQI BO KI T, VI NCRI STI NE SULFATE
MATULANE, PROCARBAZI NE HYDROCHLORI DE
MAVI K, TRANDOLAPRI L
MAXAI R, PI RBUTEROL ACETATE
MAXALT, RI ZATRI PTAN BENZOATE
MAXALT- MLT, RI ZATRI PTAN BENZOATE
MAXI DEX, DEXAMETHASONE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 33
APPENDI X A - PRODUCT NAME I NDEX
* * M * *
MAXI PI ME, CEFEPI ME HYDROCHLORI DE
MAXI TROL, DEXAMETHASONE
MAXZI DE, HYDROCHLOROTHI AZI DE
MAXZI DE- 25, HYDROCHLOROTHI AZI DE
MD- 76R, DI ATRI ZOATE MEGLUMI NE
MD- GASTROVI EW, DI ATRI ZOATE MEGLUMI NE
MDP- BRACCO, TECHNETI UM TC- 99M MEDRONATE KI T
MEBENDAZOLE, MEBENDAZOLE
MECAMYLAMI NE HYDROCHLORI DE, MECAMYLAMI NE HYDROCHLORI DE
MECLI ZI NE HYDROCHLORI DE, MECLI ZI NE HYDROCHLORI DE
MECLOFENAMATE SODI UM, MECLOFENAMATE SODI UM
MEDROL, METHYLPREDNI SOLONE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MEFENAMI C ACI D, MEFENAMI C ACI D
MEFLOQUI NE HYDROCHLORI DE, MEFLOQUI NE HYDROCHLORI DE
MEFOXI N I N PLASTI C CONTAI NER, CEFOXI TI N SODI UM
MEGACE, MEGESTROL ACETATE
MEGACE ES, MEGESTROL ACETATE
MEGATOPE, ALBUMI N I ODI NATED I - 131 SERUM
MEGESTROL ACETATE, MEGESTROL ACETATE
MEKI NI ST, TRAMETI NI B DI METHYL SULFOXI DE
MELOXI CAM, MELOXI CAM
MELPHALAN HYDROCHLORI DE, MELPHALAN HYDROCHLORI DE
MEMBRANEBLUE, TRYPAN BLUE
MEN' S ROGAI NE, MI NOXI DI L ( OTC)
MENEST, ESTROGENS, ESTERI FI ED
MENOPUR, MENOTROPI NS ( FSH
MENOSTAR, ESTRADI OL
MENTAX, BUTENAFI NE HYDROCHLORI DE
MENTAX- TC, BUTENAFI NE HYDROCHLORI DE
MEPERI DI NE HYDROCHLORI DE, MEPERI DI NE HYDROCHLORI DE
MEPERI DI NE HYDROCHLORI DE PRESERVATI VE FREE, MEPERI DI NE HYDROCHLORI DE
MEPHYTON, PHYTONADI ONE
MEPI VACAI NE HYDROCHLORI DE, MEPI VACAI NE HYDROCHLORI DE
MEPROBAMATE, MEPROBAMATE
MEPRON, ATOVAQUONE
MERCAPTOPURI NE, MERCAPTOPURI NE
MEROPENEM, MEROPENEM
MERREM, MEROPENEM
MESALAMI NE, MESALAMI NE
MESNA, MESNA
MESNEX, MESNA
MESTI NON, PYRI DOSTI GMI NE BROMI DE
METADATE CD, METHYLPHENI DATE HYDROCHLORI DE
METADATE ER, METHYLPHENI DATE HYDROCHLORI DE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METARAMI NOL BI TARTRATE, METARAMI NOL BI TARTRATE
METASTRON, STRONTI UM CHLORI DE SR- 89
METAXALONE, METAXALONE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
METHADONE HYDROCHLORI DE, METHADONE HYDROCHLORI DE
METHADONE HYDROCHLORI DE I NTENSOL, METHADONE HYDROCHLORI DE
METHADOSE, METHADONE HYDROCHLORI DE
METHAMPHETAMI NE HYDROCHLORI DE, METHAMPHETAMI NE HYDROCHLORI DE
METHAZOLAMI DE, METHAZOLAMI DE
METHENAMI NE HI PPURATE, METHENAMI NE HI PPURATE
METHERGI NE, METHYLERGONOVI NE MALEATE
METHI MAZOLE, METHI MAZOLE
METHOCARBAMOL, METHOCARBAMOL
METHOCARBAMOL AND ASPI RI N, ASPI RI N
METHOTREXATE PRESERVATI VE FREE, METHOTREXATE SODI UM
METHOTREXATE SODI UM, METHOTREXATE SODI UM
METHOTREXATE SODI UM PRESERVATI VE FREE, METHOTREXATE SODI UM
METHSCOPOLAMI NE BROMI DE, METHSCOPOLAMI NE BROMI DE
METHYCLOTHI AZI DE, METHYCLOTHI AZI DE







34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 34
APPENDI X A - PRODUCT NAME I NDEX
* * M * *
METHYLDOPA, METHYLDOPA
METHYLDOPA AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
METHYLDOPATE HYDROCHLORI DE, METHYLDOPATE HYDROCHLORI DE
METHYLERGONOVI NE MALEATE, METHYLERGONOVI NE MALEATE
METHYLI N, METHYLPHENI DATE HYDROCHLORI DE
METHYLI N ER, METHYLPHENI DATE HYDROCHLORI DE
METHYLPHENI DATE HYDROCHLORI DE, METHYLPHENI DATE HYDROCHLORI DE
METHYLPREDNI SOLONE, METHYLPREDNI SOLONE
METHYLPREDNI SOLONE ACETATE, METHYLPREDNI SOLONE ACETATE
METHYLPREDNI SOLONE SODI UM SUCCI NATE, METHYLPREDNI SOLONE SODI UM SUCCI NATE
METHYLTESTOSTERONE, METHYLTESTOSTERONE
METI PRANOLOL, METI PRANOLOL HYDROCHLORI DE
METOCLOPRAMI DE, METOCLOPRAMI DE HYDROCHLORI DE
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
METOLAZONE, METOLAZONE
METOPI RONE, METYRAPONE
METOPROLOL SUCCI NATE, METOPROLOL SUCCI NATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METOPROLOL TARTRATE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
METOZOLV ODT, METOCLOPRAMI DE HYDROCHLORI DE
METRO I . V. I N PLASTI C CONTAI NER, METRONI DAZOLE
METROCREAM, METRONI DAZOLE
METROGEL, METRONI DAZOLE
METROGEL- VAGI NAL, METRONI DAZOLE
METROLOTI ON, METRONI DAZOLE
METRONI DAZOLE, METRONI DAZOLE
METRONI DAZOLE I N PLASTI C CONTAI NER, METRONI DAZOLE
MEXI LETI NE HYDROCHLORI DE, MEXI LETI NE HYDROCHLORI DE
MI ACALCI N, CALCI TONI N SALMON
MI CARDI S, TELMI SARTAN
MI CARDI S HCT, HYDROCHLOROTHI AZI DE
MI CONAZOLE 3, MI CONAZOLE NI TRATE ( OTC)
MI CONAZOLE 3 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MI CONAZOLE 7, MI CONAZOLE NI TRATE ( OTC)
MI CONAZOLE 7 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MI CONAZOLE NI TRATE, MI CONAZOLE NI TRATE ( OTC)
MI CONAZOLE NI TRATE, MI CONAZOLE NI TRATE
MI CONAZOLE NI TRATE COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MI CORT- HC, HYDROCORTI SONE ACETATE
MI CRO- K, POTASSI UM CHLORI DE
MI CRO- K 10, POTASSI UM CHLORI DE
MI CROGESTI N 1. 5/ 30, ETHI NYL ESTRADI OL
MI CROGESTI N 1/ 20, ETHI NYL ESTRADI OL
MI CROGESTI N FE 1. 5/ 30, ETHI NYL ESTRADI OL
MI CROGESTI N FE 1/ 20, ETHI NYL ESTRADI OL
MI CRONOR, NORETHI NDRONE
MI CROZI DE, HYDROCHLOROTHI AZI DE
MI DAMOR, AMI LORI DE HYDROCHLORI DE
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
MI DAZOLAM HYDROCHLORI DE PRESERVATI VE FREE, MI DAZOLAM HYDROCHLORI DE
MI DODRI NE HYDROCHLORI DE, MI DODRI NE HYDROCHLORI DE
MI DOL LI QUI D GELS, I BUPROFEN ( OTC)
MI DOZALAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
MI FEPREX, MI FEPRI STONE
MI GERGOT, CAFFEI NE
MI GRANAL, DI HYDROERGOTAMI NE MESYLATE
MI LRI NONE LACTATE, MI LRI NONE LACTATE
MI LRI NONE LACTATE I N DEXTROSE 5%, MI LRI NONE LACTATE
MI LRI NONE LACTATE I N DEXTROSE 5%I N PLASTI C CONTAI NER, MI LRI NONE LACTATE
MI LRI NONE LACTATE I N PLASTI C CONTAI NER, MI LRI NONE LACTATE
MI NASTRI N 24 FE, ETHI NYL ESTRADI OL
MI NI PRESS, PRAZOSI N HYDROCHLORI DE
MI NI RI N, DESMOPRESSI N ACETATE
MI NI TRAN, NI TROGLYCERI N
MI NI VELLE, ESTRADI OL



















34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 35
APPENDI X A - PRODUCT NAME I NDEX
* * M * *
MI NOCI N, MI NOCYCLI NE HYDROCHLORI DE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
MI NOXI DI L, MI NOXI DI L ( OTC)
MI NOXI DI L, MI NOXI DI L
MI NOXI DI L ( FOR MEN) , MI NOXI DI L ( OTC)
MI NOXI DI L ( FOR WOMEN) , MI NOXI DI L ( OTC)
MI NOXI DI L EXTRA STRENGTH ( FOR MEN) , MI NOXI DI L ( OTC)
MI OCHOL- E, ACETYLCHOLI NE CHLORI DE
MI OSTAT, CARBACHOL
MI RALAX, POLYETHYLENE GLYCOL 3350 ( OTC)
MI RAPEX, PRAMI PEXOLE DI HYDROCHLORI DE
MI RAPEX ER, PRAMI PEXOLE DI HYDROCHLORI DE
MI RCETTE, DESOGESTREL
MI RENA, LEVONORGESTREL
MI RTAZAPI NE, MI RTAZAPI NE
MI RVASO, BRI MONI DI NE TARTRATE
MI SOPROSTOL, MI SOPROSTOL
MI TOMYCI N, MI TOMYCI N
MI TOSOL, MI TOMYCI N
MI TOXANTRONE HYDROCHLORI DE, MI TOXANTRONE HYDROCHLORI DE
MOBI C, MELOXI CAM
MODAFI NI L, MODAFI NI L
MODI CON 28, ETHI NYL ESTRADI OL
MOEXI PRI L HYDROCHLORI DE, MOEXI PRI L HYDROCHLORI DE
MOEXI PRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
MOMETASONE FUROATE, MOMETASONE FUROATE
MONI STAT 1 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MONI STAT 3, MI CONAZOLE NI TRATE ( OTC)
MONI STAT 3, MI CONAZOLE NI TRATE
MONI STAT 3 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MONI STAT 3 COMBI NATI ON PACK ( PREFI LLED) , MI CONAZOLE NI TRATE ( OTC)
MONI STAT 7, MI CONAZOLE NI TRATE ( OTC)
MONI STAT 7 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MONI STAT- 3 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MONO- LI NYAH, ETHI NYL ESTRADI OL
MONODOX, DOXYCYCLI NE
MONOKET, I SOSORBI DE MONONI TRATE
MONTELUKAST SODI UM, MONTELUKAST SODI UM
MONUROL, FOSFOMYCI N TROMETHAMI NE
MORPHI NE SULFATE, MORPHI NE SULFATE
MOTOFEN, ATROPI NE SULFATE
MOTRI N I B, I BUPROFEN ( OTC)
MOTRI N MI GRAI NE PAI N, I BUPROFEN ( OTC)
MOVI PREP, ASCORBI C ACI D
MOXATAG, AMOXI CI LLI N
MOXEZA, MOXI FLOXACI N HYDROCHLORI DE
MOZOBI L, PLERI XAFOR
MPI DMSA KI DNEY REAGENT, TECHNETI UM TC- 99M SUCCI MER KI T
MPI I NDI UM DTPA I N 111, I NDI UM I N- 111 PENTETATE DI SODI UM
MS CONTI N, MORPHI NE SULFATE
MUCI NEX, GUAI FENESI N ( OTC)
MUCI NEX D, GUAI FENESI N ( OTC)
MUCI NEX DM, DEXTROMETHORPHAN HYDROBROMI DE ( OTC)
MULTAQ, DRONEDARONE HYDROCHLORI DE
MULTI HANCE, GADOBENATE DI MEGLUMI NE
MULTI HANCE MULTI PACK, GADOBENATE DI MEGLUMI NE
MUPI ROCI N, MUPI ROCI N
MUPI ROCI N, MUPI ROCI N CALCI UM
MUSE, ALPROSTADI L
MUSTARGEN, MECHLORETHAMI NE HYDROCHLORI DE
MYAMBUTOL, ETHAMBUTOL HYDROCHLORI DE
MYCAMI NE, MI CAFUNGI N SODI UM
MYCELEX- 7, CLOTRI MAZOLE ( OTC)
MYCELEX- 7 COMBI NATI ON PACK, CLOTRI MAZOLE ( OTC)
MYCOBUTI N, RI FABUTI N





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 36
APPENDI X A - PRODUCT NAME I NDEX
* * M * *
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
MYCOPHENOLI C ACI D, MYCOPHENOLI C ACI D
MYDRI ACYL, TROPI CAMI DE
MYFORTI C, MYCOPHENOLI C ACI D
MYLERAN, BUSULFAN
MYORI SAN, I SOTRETI NOI N
MYOVI EW, TECHNETI UM TC- 99M TETROFOSMI N KI T
MYOVI EW30ML, TECHNETI UM TC- 99M TETROFOSMI N KI T
MYRBETRI Q, MI RABEGRON
MYSOLI NE, PRI MI DONE
MYTELASE, AMBENONI UM CHLORI DE
MYZI LRA, ETHI NYL ESTRADI OL
* * N * *
NABUMETONE, NABUMETONE
NADOLOL, NADOLOL
NADOLOL AND BENDROFLUMETHAZI DE, BENDROFLUMETHI AZI DE
NADOLOL AND BENDROFLUMETHI AZI DE, BENDROFLUMETHI AZI DE
NAFCI LLI N SODI UM, NAFCI LLI N SODI UM
NAFTI N, NAFTI FI NE HYDROCHLORI DE
NALBUPHI NE HYDROCHLORI DE, NALBUPHI NE HYDROCHLORI DE
NALFON, FENOPROFEN CALCI UM
NALLPEN I N PLASTI C CONTAI NER, NAFCI LLI N SODI UM
NALOXONE HYDROCHLORI DE, NALOXONE HYDROCHLORI DE
NALOXONE HYDROCHLORI DE AND PENTAZOCI NE HYDROCHLORI DE, NALOXONE HYDROCHLORI DE
NALTREXONE HYDROCHLORI DE, NALTREXONE HYDROCHLORI DE
NAMENDA, MEMANTI NE HYDROCHLORI DE
NAMENDA XR, MEMANTI NE HYDROCHLORI DE
NANDROLONE DECANOATE, NANDROLONE DECANOATE
NAPHAZOLI NE HYDROCHLORI DE, NAPHAZOLI NE HYDROCHLORI DE
NAPHAZOLI NE HYDROCHLORI DE AND PHENI RAMI NE MALEATE, NAPHAZOLI NE HYDROCHLORI DE ( OTC)
NAPHCON- A, NAPHAZOLI NE HYDROCHLORI DE ( OTC)
NAPRELAN, NAPROXEN SODI UM
NAPROSYN, NAPROXEN
NAPROXEN, NAPROXEN
NAPROXEN AND ESOMEPRAZOLE MAGNESI UM, ESOMEPRAZOLE MAGNESI UM
NAPROXEN SODI UM, NAPROXEN SODI UM ( OTC)
NAPROXEN SODI UM, NAPROXEN SODI UM
NAPROXEN SODI UM AND PSEUDOEPHEDRI NE HYDROCHLORI DE, NAPROXEN SODI UM ( OTC)
NARATRI PTAN, NARATRI PTAN
NARATRI PTAN, NARATRI PTAN HYDROCHLORI DE
NARDI L, PHENELZI NE SULFATE
NAROPI N, ROPI VACAI NE HYDROCHLORI DE
NASACORT ALLERGY 24 HOUR, TRI AMCI NOLONE ACETONI DE ( OTC)
NASCOBAL, CYANOCOBALAMI N
NASONEX, MOMETASONE FUROATE MONOHYDRATE
NATACYN, NATAMYCI N
NATAZI A, DI ENOGEST
NATEGLI NI DE, NATEGLI NI DE
NATRECOR, NESI RI TI DE RECOMBI NANT
NATROBA, SPI NOSAD
NAVANE, THI OTHI XENE
NAVELBI NE, VI NORELBI NE TARTRATE
NAVSTEL, CALCI UM CHLORI DE
NEBUPENT, PENTAMI DI NE I SETHI ONATE
NEDOCROMI L SODI UM, NEDOCROMI L SODI UM
NEFAZODONE HYDROCHLORI DE, NEFAZODONE HYDROCHLORI DE
NEMBUTAL SODI UM, PENTOBARBI TAL SODI UM
NEO- FRADI N, NEOMYCI N SULFATE
NEOMYCI N AND POLYMYXI N B SULFATE, NEOMYCI N SULFATE
NEOMYCI N AND POLYMYXI N B SULFATES AND BACI TRACI N ZI NC, BACI TRACI N ZI NC
NEOMYCI N AND POLYMYXI N B SULFATES AND DEXAMETHASONE, DEXAMETHASONE
NEOMYCI N AND POLYMYXI N B SULFATES AND GRAMI CI DI N, GRAMI CI DI N
NEOMYCI N AND POLYMYXI N B SULFATES AND HYDROCORTI SONE, HYDROCORTI SONE
NEOMYCI N AND POLYMYXI N B SULFATES, BACI TRACI N ZI NC AND HYDROCORTI SONE, BACI TRACI N ZI NC









34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 37
APPENDI X A - PRODUCT NAME I NDEX
* * N * *
NEOMYCI N SULFATE, NEOMYCI N SULFATE
NEOPAP, ACETAMI NOPHEN ( OTC)
NEOPROFEN, I BUPROFEN LYSI NE
NEORAL, CYCLOSPORI NE
NEOSPORI N, GRAMI CI DI N
NEOSPORI N G. U. I RRI GANT, NEOMYCI N SULFATE
NEPHRAMI NE 5. 4%, AMI NO ACI DS
NESACAI NE, CHLOROPROCAI NE HYDROCHLORI DE
NESACAI NE- MPF, CHLOROPROCAI NE HYDROCHLORI DE
NESI NA, ALOGLI PTI N BENZOATE
NEUPRO, ROTI GOTI NE
NEUROLI TE, TECHNETI UM TC- 99M BI CI SATE KI T
NEURONTI N, GABAPENTI N
NEVANAC, NEPAFENAC
NEVI RAPI NE, NEVI RAPI NE
NEXAVAR, SORAFENI B TOSYLATE
NEXCEDE, KETOPROFEN ( OTC)
NEXI UM, ESOMEPRAZOLE MAGNESI UM
NEXI UM I V, ESOMEPRAZOLE SODI UM
NEXPLANON, ETONOGESTREL
NEXTERONE, AMI ODARONE HYDROCHLORI DE
NI ACI N, NI ACI N
NI ACOR, NI ACI N
NI ASPAN, NI ACI N
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
NI CODERM CQ, NI COTI NE ( OTC)
NI CORETTE, NI COTI NE POLACRI LEX ( OTC)
NI CORETTE ( MI NT) , NI COTI NE POLACRI LEX ( OTC)
NI COTI NE, NI COTI NE ( OTC)
NI COTI NE POLACRI LEX, NI COTI NE POLACRI LEX ( OTC)
NI COTROL, NI COTI NE
NI FEDI PI NE, NI FEDI PI NE
NI LANDRON, NI LUTAMI DE
NI MBEX, CI SATRACURI UM BESYLATE
NI MBEX PRESERVATI VE FREE, CI SATRACURI UM BESYLATE
NI MODI PI NE, NI MODI PI NE
NI PENT, PENTOSTATI N
NI RAVAM, ALPRAZOLAM
NI SOLDI PI NE, NI SOLDI PI NE
NI THI ODOTE, SODI UM NI TRI TE
NI TRO- DUR, NI TROGLYCERI N
NI TROFURANTOI N, NI TROFURANTOI N
NI TROFURANTOI N, NI TROFURANTOI N, MACROCRYSTALLI NE
NI TROFURANTOI N ( MONOHYDRATE/ MACROCRYSTALS) , NI TROFURANTOI N
NI TROGLYCERI N, NI TROGLYCERI N
NI TROGLYCERI N I N DEXTROSE 5%, NI TROGLYCERI N
NI TROLI NGUAL PUMPSPRAY, NI TROGLYCERI N
NI TROMI ST, NI TROGLYCERI N
NI TROPRESS, SODI UM NI TROPRUSSI DE
NI TROSTAT, NI TROGLYCERI N
NI X, PERMETHRI N ( OTC)
NI ZATI DI NE, NI ZATI DI NE
NI ZORAL, KETOCONAZOLE
NI ZORAL A- D, KETOCONAZOLE ( OTC)
NOR- QD, NORETHI NDRONE
NORCO, ACETAMI NOPHEN
NORDETTE- 28, ETHI NYL ESTRADI OL
NORDI TROPI N FLEXPRO, SOMATROPI N RECOMBI NANT
NORDI TROPI N NORDI FLEX, SOMATROPI N RECOMBI NANT
NOREPI NEPHRI NE BI TARTRATE, NOREPI NEPHRI NE BI TARTRATE
NORETHI DRONE, NORETHI NDRONE
NORETHI N 1/ 35E- 21, ETHI NYL ESTRADI OL
NORETHI N 1/ 35E- 28, ETHI NYL ESTRADI OL
NORETHI NDRONE, NORETHI NDRONE
NORETHI NDRONE ACETATE, NORETHI NDRONE ACETATE




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 38
APPENDI X A - PRODUCT NAME I NDEX
* * N * *
NORETHI NDRONE ACETATE AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
NORETHI NDRONE ACETATE AND ETHI NYL ESTRADI OL AND FERROUS FUMARATE, ETHI NYL ESTRADI OL
NORETHI NDRONE AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
NORETHI NDRONE AND ETHI NYL ESTRADI OL ( 10/ 11) , ETHI NYL ESTRADI OL
NORETHI NDRONE AND ETHI NYL ESTRADI OL ( 7/ 14) , ETHI NYL ESTRADI OL
NORETHI NDRONE AND ETHI NYL ESTRADI OL AND FERROUS FUMARATE, ETHI NYL ESTRADI OL
NORFLEX, ORPHENADRI NE CI TRATE
NORGESI C, ASPI RI N
NORGESI C FORTE, ASPI RI N
NORGESTI MATE AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
NORI NYL 1+35 21- DAY, ETHI NYL ESTRADI OL
NORI NYL 1+35 28- DAY, ETHI NYL ESTRADI OL
NORI NYL 1+50 28- DAY, MESTRANOL
NORI TATE, METRONI DAZOLE
NORMOCARB HF 25, MAGNESI UM CHLORI DE
NORMOCARB HF 35, MAGNESI UM CHLORI DE
NORMOSOL- M AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
NORMOSOL- R AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
NORMOSOL- R I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
NOROXI N, NORFLOXACI N
NORPACE, DI SOPYRAMI DE PHOSPHATE
NORPACE CR, DI SOPYRAMI DE PHOSPHATE
NORPRAMI N, DESI PRAMI NE HYDROCHLORI DE
NORTREL 0. 5/ 35- 28, ETHI NYL ESTRADI OL
NORTREL 1/ 35- 21, ETHI NYL ESTRADI OL
NORTREL 1/ 35- 28, ETHI NYL ESTRADI OL
NORTREL 7/ 7/ 7, ETHI NYL ESTRADI OL
NORTRI PTYLI NE HYDROCHLORI DE, NORTRI PTYLI NE HYDROCHLORI DE
NORVASC, AMLODI PI NE BESYLATE
NORVI R, RI TONAVI R
NOVOLI N 70/ 30, I NSULI N RECOMBI NANT HUMAN ( OTC)
NOVOLI N N, I NSULI N SUSP I SOPHANE RECOMBI NANT HUMAN ( OTC)
NOVOLI N R, I NSULI N RECOMBI NANT HUMAN ( OTC)
NOVOLOG, I NSULI N ASPART RECOMBI NANT
NOVOLOG FLEXPEN, I NSULI N ASPART RECOMBI NANT
NOVOLOG MI X 70/ 30, I NSULI N ASPART PROTAMI NE RECOMBI NANT
NOVOLOG MI X 70/ 30 FLEXPEN, I NSULI N ASPART PROTAMI NE RECOMBI NANT
NOVOLOG PENFI LL, I NSULI N ASPART RECOMBI NANT
NOXAFI L, POSACONAZOLE
NUCYNTA, TAPENTADOL HYDROCHLORI DE
NUCYNTA ER, TAPENTADOL HYDROCHLORI DE
NUEDEXTA, DEXTROMETHORPHAN HYDROBROMI DE
NULYTELY, POLYETHYLENE GLYCOL 3350
NULYTELY- FLAVORED, POLYETHYLENE GLYCOL 3350
NUTRACORT, HYDROCORTI SONE
NUTRESTORE, GLUTAMI NE
NUTRI LI PI D 10%, SOYBEAN OI L
NUTRI LI PI D 20%, SOYBEAN OI L
NUTROPI N, SOMATROPI N RECOMBI NANT
NUTROPI N AQ, SOMATROPI N RECOMBI NANT
NUTROPI N AQ PEN, SOMATROPI N RECOMBI NANT
NUVARI NG, ETHI NYL ESTRADI OL
NUVI GI L, ARMODAFI NI L
NYMALI ZE, NI MODI PI NE
NYSTATI N, NYSTATI N
NYSTATI N AND TRI AMCI NOLONE ACETONI DE, NYSTATI N
NYSTOP, NYSTATI N
* * O * *
OCTOCAI NE, EPI NEPHRI NE
OCTREOSCAN, I NDI UM I N- 111 PENTETREOTI DE KI T
OCTREOTI DE ACETATE, OCTREOTI DE ACETATE
OCTREOTI DE ACETATE ( PRESERVATI VE FREE) , OCTREOTI DE ACETATE
OCUCLEAR, OXYMETAZOLI NE HYDROCHLORI DE ( OTC)
OCUFEN, FLURBI PROFEN SODI UM



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 39
APPENDI X A - PRODUCT NAME I NDEX
* * O * *
OCUFLOX, OFLOXACI N
OCUPRESS, CARTEOLOL HYDROCHLORI DE
OFI RMEV, ACETAMI NOPHEN
OFLOXACI N, OFLOXACI N
OGEN . 625, ESTROPI PATE
OGEN 1. 25, ESTROPI PATE
OGEN 2. 5, ESTROPI PATE
OGEN 5, ESTROPI PATE
OGESTREL 0. 5/ 50- 28, ETHI NYL ESTRADI OL
OLANZAPI NE, OLANZAPI NE
OLANZAPI NE AND FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
OLEPTRO, TRAZODONE HYDROCHLORI DE
OLUX, CLOBETASOL PROPI ONATE
OLUX E, CLOBETASOL PROPI ONATE
OLYSI O, SI MEPREVI R
OMEPRAZOLE, OMEPRAZOLE ( OTC)
OMEPRAZOLE, OMEPRAZOLE
OMEPRAZOLE AND CLARI THROMYCI N AND AMOXI CI LLI N, AMOXI CI LLI N
OMEPRAZOLE AND SODI UM BI CARBONATE, OMEPRAZOLE
OMEPRAZOLE MAGNESI UM, OMEPRAZOLE MAGNESI UM ( OTC)
OMNARI S, CI CLESONI DE
OMNI PAQUE 140, I OHEXOL
OMNI PAQUE 180, I OHEXOL
OMNI PAQUE 240, I OHEXOL
OMNI PAQUE 300, I OHEXOL
OMNI PAQUE 350, I OHEXOL
OMNI PRED, PREDNI SOLONE ACETATE
OMNI SCAN, GADODI AMI DE
OMNI TROPE, SOMATROPI N RECOMBI NANT
ONDANSETRON, ONDANSETRON
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONFI , CLOBAZAM
ONGLYZA, SAXAGLI PTI N HYDROCHLORI DE
ONMEL, I TRACONAZOLE
OPANA, OXYMORPHONE HYDROCHLORI DE
OPANA ER, OXYMORPHONE HYDROCHLORI DE
OPCON- A, NAPHAZOLI NE HYDROCHLORI DE ( OTC)
OPHTHAI NE, PROPARACAI NE HYDROCHLORI DE
OPHTHETI C, PROPARACAI NE HYDROCHLORI DE
OPSUMI T, MACI TENTAN
OPTI CROM, CROMOLYN SODI UM
OPTI MARK, GADOVERSETAMI DE
OPTI MARK I N PLASTI C CONTAI NER, GADOVERSETAMI DE
OPTI PRANOLOL, METI PRANOLOL HYDROCHLORI DE
OPTI RAY 240, I OVERSOL
OPTI RAY 300, I OVERSOL
OPTI RAY 320, I OVERSOL
OPTI RAY 350, I OVERSOL
OPTI SON, ALBUMI N HUMAN
OPTI VAR, AZELASTI NE HYDROCHLORI DE
ORABLOC, ARTI CAI NE HYDROCHLORI DE
ORACEA, DOXYCYCLI NE
ORAP, PI MOZI DE
ORAPRED, PREDNI SOLONE SODI UM PHOSPHATE
ORAPRED ODT, PREDNI SOLONE SODI UM PHOSPHATE
ORAQI X, LI DOCAI NE
ORAVERSE, PHENTOLAMI NE MESYLATE
ORAVI G, MI CONAZOLE
ORENI TRAM, TREPROSTI NI L
ORETI C, HYDROCHLOROTHI AZI DE
ORFADI N, NI TI SI NONE
ORPHENADRI NE CI TRATE, ORPHENADRI NE CI TRATE
ORPHENADRI NE CI TRATE, ASPI RI N, AND CAFFEI NE, ASPI RI N
ORSYTHI A, ETHI NYL ESTRADI OL

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 40
APPENDI X A - PRODUCT NAME I NDEX
* * O * *
ORTHO CYCLEN- 28, ETHI NYL ESTRADI OL
ORTHO EVRA, ETHI NYL ESTRADI OL
ORTHO TRI - CYCLEN, ETHI NYL ESTRADI OL
ORTHO TRI - CYCLEN LO, ETHI NYL ESTRADI OL
ORTHO- CEPT, DESOGESTREL
ORTHO- NOVUM 1/ 35- 28, ETHI NYL ESTRADI OL
ORTHO- NOVUM 7/ 7/ 7- 28, ETHI NYL ESTRADI OL
ORVATEN, MI DODRI NE HYDROCHLORI DE
OSENI , ALOGLI PTI N BENZOATE
OSMI TROL 10%I N WATER, MANNI TOL
OSMI TROL 10%I N WATER I N PLASTI C CONTAI NER, MANNI TOL
OSMI TROL 15%I N WATER, MANNI TOL
OSMI TROL 15%I N WATER I N PLASTI C CONTAI NER, MANNI TOL
OSMI TROL 20%I N WATER, MANNI TOL
OSMI TROL 20%I N WATER I N PLASTI C CONTAI NER, MANNI TOL
OSMI TROL 5%I N WATER, MANNI TOL
OSMI TROL 5%I N WATER I N PLASTI C CONTAI NER, MANNI TOL
OSMOPREP, SODI UM PHOSPHATE, DI BASI C, ANHYDROUS
OSPHENA, OSPEMI FENE
OTI CAI R, HYDROCORTI SONE
OTREXUP, METHOTREXATE
OVCON- 35, ETHI NYL ESTRADI OL
OVI DE, MALATHI ON
OVI DREL, CHORI OGONADOTROPI N ALFA
OXACI LLI N SODI UM, OXACI LLI N SODI UM
OXALI PLATI N, OXALI PLATI N
OXANDRI N, OXANDROLONE
OXANDROLONE, OXANDROLONE
OXAPROZI N, OXAPROZI N
OXAZEPAM, OXAZEPAM
OXCARBAZEPI NE, OXCARBAZEPI NE
OXECTA, OXYCODONE HYDROCHLORI DE
OXI LAN- 300, I OXI LAN
OXI LAN- 350, I OXI LAN
OXI STAT, OXI CONAZOLE NI TRATE
OXSORALEN, METHOXSALEN
OXSORALEN- ULTRA, METHOXSALEN
OXTELLAR XR, OXCARBAZEPI NE
OXYBUTYNI N CHLORI DE, OXYBUTYNI N CHLORI DE
OXYCET, ACETAMI NOPHEN
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
OXYCODONE AND ASPI RI N, ASPI RI N
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
OXYCODONE HYDROCHLORI DE AND I BUPROFEN, I BUPROFEN
OXYCONTI N, OXYCODONE HYDROCHLORI DE
OXYMORPHONE HYDROCHLORI DE, OXYMORPHONE HYDROCHLORI DE
OXYTOCI N, OXYTOCI N
OXYTROL, OXYBUTYNI N
OXYTROL FOR WOMEN, OXYBUTYNI N ( OTC)
OZURDEX, DEXAMETHASONE
* * P * *
PACERONE, AMI ODARONE HYDROCHLORI DE
PACLI TAXEL, PACLI TAXEL
PAMELOR, NORTRI PTYLI NE HYDROCHLORI DE
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
PAMI NE, METHSCOPOLAMI NE BROMI DE
PAMI NE FORTE, METHSCOPOLAMI NE BROMI DE
PANCREAZE, PANCRELI PASE ( AMYLASE
PANCURONI UM BROMI DE, PANCURONI UM BROMI DE
PANDEL, HYDROCORTI SONE PROBUTATE
PANRETI N, ALI TRETI NOI N
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
PARAFON FORTE DSC, CHLORZOXAZONE
PARAGARD T 380A, COPPER






34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 41
APPENDI X A - PRODUCT NAME I NDEX
* * P * *
PARCOPA, CARBI DOPA
PAREMYD, HYDROXYAMPHETAMI NE HYDROBROMI DE
PARI CALCI TOL, PARI CALCI TOL
PARLODEL, BROMOCRI PTI NE MESYLATE
PARNATE, TRANYLCYPROMI NE SULFATE
PAROEX, CHLORHEXI DI NE GLUCONATE
PAROMOMYCI N SULFATE, PAROMOMYCI N SULFATE
PAROXETI NE HYDROCHLORI DE, PAROXETI NE HYDROCHLORI DE
PASER, AMI NOSALI CYLI C ACI D
PATADAY, OLOPATADI NE HYDROCHLORI DE
PATANASE, OLOPATADI NE HYDROCHLORI DE
PATANOL, OLOPATADI NE HYDROCHLORI DE
PAXI L, PAROXETI NE HYDROCHLORI DE
PAXI L CR, PAROXETI NE HYDROCHLORI DE
PCE, ERYTHROMYCI N
PEDI AMYCI N, ERYTHROMYCI N ETHYLSUCCI NATE
PEDI AMYCI N 400, ERYTHROMYCI N ETHYLSUCCI NATE
PEDI APRED, PREDNI SOLONE SODI UM PHOSPHATE
PEDI ATRI C ADVI L, I BUPROFEN ( OTC)
PEDI OTI C, HYDROCORTI SONE
PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
PEG- 3350; POTASSI UM CHLORI DE; SODI UM BI CARBONATE; SODI UM CHLORI DE, POLYETHYLENE GLYCOL 3350
PEGANONE, ETHOTOI N
PENI CI LLI N G POTASSI UM, PENI CI LLI N G POTASSI UM
PENI CI LLI N G POTASSI UM I N PLASTI C CONTAI NER, PENI CI LLI N G POTASSI UM
PENI CI LLI N G PROCAI NE, PENI CI LLI N G PROCAI NE
PENI CI LLI N G SODI UM, PENI CI LLI N G SODI UM
PENI CI LLI N V POTASSI UM, PENI CI LLI N V POTASSI UM
PENI CI LLI N- VK, PENI CI LLI N V POTASSI UM
PENLAC, CI CLOPI ROX
PENNSAI D, DI CLOFENAC SODI UM
PENTAM, PENTAMI DI NE I SETHI ONATE
PENTAMI DI NE I SETHI ONATE, PENTAMI DI NE I SETHI ONATE
PENTASA, MESALAMI NE
PENTOLAI R, CYCLOPENTOLATE HYDROCHLORI DE
PENTOSTATI N, PENTOSTATI N
PENTOXI FYLLI NE, PENTOXI FYLLI NE
PENTOXI L, PENTOXI FYLLI NE
PEPCI D, FAMOTI DI NE
PEPCI D AC, FAMOTI DI NE ( OTC)
PEPCI D AC , FAMOTI DI NE ( OTC)
PEPCI D COMPLETE, CALCI UM CARBONATE ( OTC)
PERCOCET, ACETAMI NOPHEN
PERCODAN, ASPI RI N
PERFOROMI ST, FORMOTEROL FUMARATE
PERI DEX, CHLORHEXI DI NE GLUCONATE
PERI NDOPRI L ERBUMI NE, PERI NDOPRI L ERBUMI NE
PERI OCHI P, CHLORHEXI DI NE GLUCONATE
PERI OGARD, CHLORHEXI DI NE GLUCONATE
PERI OSTAT, DOXYCYCLI NE HYCLATE
PERMAPEN, PENI CI LLI N G BENZATHI NE
PERMETHRI N, PERMETHRI N ( OTC)
PERMETHRI N, PERMETHRI N
PERPHENAZI NE, PERPHENAZI NE
PERPHENAZI NE AND AMI TRI PTYLI NE HYDROCHLORI DE, AMI TRI PTYLI NE HYDROCHLORI DE
PERSANTI NE, DI PYRI DAMOLE
PERTZYE, PANCRELI PASE ( AMYLASE
PEXEVA, PAROXETI NE MESYLATE
PFI ZERPEN, PENI CI LLI N G POTASSI UM
PHARMASEAL SCRUB CARE, CHLORHEXI DI NE GLUCONATE ( OTC)
PHENDI METRAZI NE TARTRATE, PHENDI METRAZI NE TARTRATE
PHENELZI NE SULFATE, PHENELZI NE SULFATE
PHENOXYBENZAMI NE HYDROCHLORI DE, PHENOXYBENZAMI NE HYDROCHLORI DE
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
PHENTERMI NE RESI N COMPLEX, PHENTERMI NE RESI N COMPLEX



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 42
APPENDI X A - PRODUCT NAME I NDEX
* * P * *
PHENTOLAMI NE MESYLATE, PHENTOLAMI NE MESYLATE
PHENYLEPHRI NE HYDROCHLORI DE, PHENYLEPHRI NE HYDROCHLORI DE
PHENYLEPHRI NE HYDROCHLORI DE AND PROMETHAZI NE HYDROCHLORI DE, PHENYLEPHRI NE HYDROCHLORI DE
PHENYTEK, PHENYTOI N SODI UM
PHENYTOI N, PHENYTOI N
PHENYTOI N SODI UM, PHENYTOI N SODI UM
PHI LI TH, ETHI NYL ESTRADI OL
PHI SOHEX, HEXACHLOROPHENE
PHOSLO GELCAPS, CALCI UM ACETATE
PHOSLYRA, CALCI UM ACETATE
PHOSPHOLI NE I ODI DE, ECHOTHI OPHATE I ODI DE
PHOTOFRI N, PORFI MER SODI UM
PHRENI LI N FORTE, ACETAMI NOPHEN
PHRENI LI N WI TH CAFFEI NE AND CODEI NE, ACETAMI NOPHEN
PHYSI OLYTE I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
PHYSI OSOL I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
PHYTONADI ONE, PHYTONADI ONE
PI CATO, I NGENOL MEBUTATE
PI LOCARPI NE HYDROCHLORI DE, PI LOCARPI NE HYDROCHLORI DE
PI LOPI NE HS, PI LOCARPI NE HYDROCHLORI DE
PI MTREA, DESOGESTREL
PI NDOLOL, PI NDOLOL
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
PI OGLI TAZONE HYDROCHLORI DE AND GLI MEPI RI DE, GLI MEPI RI DE
PI OGLI TAZONE HYDROCHLORI DE AND METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
PI PERACI LLI N, PI PERACI LLI N SODI UM
PI PERACI LLI N AND TAZOBACTAM, PI PERACI LLI N SODI UM
PI RMELLA 1/ 35, ETHI NYL ESTRADI OL
PI RMELLA 7/ 7/ 7, ETHI NYL ESTRADI OL
PI ROXI CAM, PI ROXI CAM
PI TOCI N, OXYTOCI N
PLAN B, LEVONORGESTREL ( OTC)
PLAN B, LEVONORGESTREL
PLAN B ONE- STEP, LEVONORGESTREL ( OTC)
PLAQUENI L, HYDROXYCHLOROQUI NE SULFATE
PLASMA- LYTE 148 AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
PLASMA- LYTE 148 I N WATER I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
PLASMA- LYTE 56 AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
PLASMA- LYTE 56 I N PLASTI C CONTAI NER, MAGNESI UM ACETATE TETRAHYDRATE
PLASMA- LYTE A I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
PLASMA- LYTE M AND DEXTROSE 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PLASMA- LYTE R I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PLAVI X, CLOPI DOGREL BI SULFATE
PLEGI SOL I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PLENDI L, FELODI PI NE
PLETAL, CI LOSTAZOL
PLI AGLI S, LI DOCAI NE
PODOFI LOX, PODOFI LOX
POLOCAI NE, MEPI VACAI NE HYDROCHLORI DE
POLOCAI NE- MPF, MEPI VACAI NE HYDROCHLORI DE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 ( OTC)
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
POLYMYCI N B SULFATE, POLYMYXI N B SULFATE
POLYMYXI N B SULFATE, POLYMYXI N B SULFATE
POLYTRI M, POLYMYXI N B SULFATE
POMALYST, POMALI DOMI DE
PONSTEL, MEFENAMI C ACI D
PORTI A- 28, ETHI NYL ESTRADI OL
POTASSI UM ACETATE I N PLASTI C CONTAI NER, POTASSI UM ACETATE
POTASSI UM CHLORI DE, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 43
APPENDI X A - PRODUCT NAME I NDEX
* * P * *
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 149%I N SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, POTASSI UM
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE 0. 15%I N SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 0. 15%I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 224%I N SODI UM CHLORI DE 0. 9%, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 0. 3%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 10MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 15MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 15MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 15MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 44
APPENDI X A - PRODUCT NAME I NDEX
* * P * *
POTASSI UM CHLORI DE 15MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 15MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%I N SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 20MEQ I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE 30MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE 40MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 40MEQ I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CI TRATE, POTASSI UM CI TRATE
POTI GA, EZOGABI NE
POVI DONE I ODI NE, POVI DONE- I ODI NE ( OTC)
PRADAXA, DABI GATRAN ETEXI LATE MESYLATE
PRALI DOXI ME CHLORI DE, PRALI DOXI ME CHLORI DE
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
PRAMOSONE, HYDROCORTI SONE ACETATE
PRANDI MET, METFORMI N HYDROCHLORI DE
PRANDI N, REPAGLI NI DE
PRAVACHOL, PRAVASTATI N SODI UM
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM
PRAZOSI N HYDROCHLORI DE, PRAZOSI N HYDROCHLORI DE
PRE- OP, HEXACHLOROPHENE
PRE- OP I I , HEXACHLOROPHENE
PRE- PEN, BENZYLPENI CI LLOYL POLYLYSI NE
PRECEDEX, DEXMEDETOMI DI NE HYDROCHLORI DE
PRECOSE, ACARBOSE
PRED FORTE, PREDNI SOLONE ACETATE
PRED MI LD, PREDNI SOLONE ACETATE
PRED- G, GENTAMI CI N SULFATE
PREDNI CARBATE, PREDNI CARBATE
PREDNI SOLONE, PREDNI SOLONE
PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
PREDNI SONE, PREDNI SONE
PREDNI SONE I NTENSOL, PREDNI SONE
PREFEST, ESTRADI OL
PREGABALI N, PREGABALI N
PREGNYL, GONADOTROPI N, CHORI ONI C
PRELONE, PREDNI SOLONE
PREMARI N, ESTROGENS, CONJ UGATED
PREMASOL 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
PREMASOL 6%I N PLASTI C CONTAI NER, AMI NO ACI DS
PREMPHASE 14/ 14, ESTROGENS, CONJ UGATED






34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 45
APPENDI X A - PRODUCT NAME I NDEX
* * P * *
PREMPRO, ESTROGENS, CONJ UGATED
PREPI DI L, DI NOPROSTONE
PREPOPI K, CI TRI C ACI D
PREVACI D, LANSOPRAZOLE
PREVACI D 24 HR, LANSOPRAZOLE ( OTC)
PREVALI TE, CHOLESTYRAMI NE
PREVANTI CS MAXI SWABSTI CK, CHLORHEXI DI NE GLUCONATE ( OTC)
PREVANTI CS SWAB, CHLORHEXI DI NE GLUCONATE ( OTC)
PREVANTI CS SWABSTI CK, CHLORHEXI DI NE GLUCONATE ( OTC)
PREVI FEM, ETHI NYL ESTRADI OL
PREVPAC, AMOXI CI LLI N
PREZI STA, DARUNAVI R ETHANOLATE
PRI ALT, ZI CONOTI DE ACETATE
PRI FTI N, RI FAPENTI NE
PRI LOCAI NE HYDROCHLORI DE, PRI LOCAI NE HYDROCHLORI DE
PRI LOCAI NE HYDROCHLORI DE AND EPI NEPHRI NE BI TARTRATE, EPI NEPHRI NE BI TARTRATE
PRI LOSEC, OMEPRAZOLE
PRI LOSEC, OMEPRAZOLE MAGNESI UM
PRI LOSEC OTC, OMEPRAZOLE MAGNESI UM ( OTC)
PRI MAQUI NE, PRI MAQUI NE PHOSPHATE
PRI MAXI N, CI LASTATI N SODI UM
PRI MI DONE, PRI MI DONE
PRI MSOL, TRI METHOPRI M HYDROCHLORI DE
PRI NI VI L, LI SI NOPRI L
PRI NZI DE, HYDROCHLOROTHI AZI DE
PRI SMASOL B22GK 2/ 0 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL B22GK 4/ 0 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL B22GK 4/ 2. 5 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BGK 0/ 2. 5 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BGK 2/ 0 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BGK 2/ 3. 5 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BGK 4/ 0/ 1. 2 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BGK 4/ 2. 5 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BK 0/ 0/ 1. 2 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BK 0/ 3. 5 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI STI Q, DESVENLAFAXI NE SUCCI NATE
PROAI R HFA, ALBUTEROL SULFATE
PROBALAN, PROBENECI D
PROBENECI D, PROBENECI D
PROBENECI D AND COLCHI CI NE, COLCHI CI NE
PROCAI NAMI DE HYDROCHLORI DE, PROCAI NAMI DE HYDROCHLORI DE
PROCALAMI NE, AMI NO ACI DS
PROCARDI A, NI FEDI PI NE
PROCARDI A XL, NI FEDI PI NE
PROCHLORPERAZI NE, PROCHLORPERAZI NE
PROCHLORPERAZI NE EDI SYLATE, PROCHLORPERAZI NE EDI SYLATE
PROCHLORPERAZI NE MALEATE, PROCHLORPERAZI NE MALEATE
PROCOMP, PROCHLORPERAZI NE MALEATE
PROCTOFOAM HC, HYDROCORTI SONE ACETATE
PROCYSBI , CYSTEAMI NE BI TARTRATE
PROFEN, I BUPROFEN ( OTC)
PROFERDEX, I RON DEXTRAN
PROGESTERONE, PROGESTERONE
PROGLYCEM, DI AZOXI DE
PROGRAF, TACROLI MUS
PROHANCE, GADOTERI DOL
PROHANCE MULTI PACK, GADOTERI DOL
PROLENSA, BROMFENAC SODI UM
PROMACTA, ELTROMBOPAG OLAMI NE
PROMETH HYDROCHLORI DE, PHENYLEPHRI NE HYDROCHLORI DE W/ CODEI NE PHOSPHATE, CODEI NE PHOSPHATE
PROMETH VC PLAI N, PHENYLEPHRI NE HYDROCHLORI DE
PROMETH VC W/ CODEI NE, CODEI NE PHOSPHATE
PROMETH W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMI DE
PROMETHAZI NE DM, DEXTROMETHORPHAN HYDROBROMI DE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 46
APPENDI X A - PRODUCT NAME I NDEX
* * P * *
PROMETHAZI NE HYDROCHLORI DE AND CODEI NE PHOSPHATE, CODEI NE PHOSPHATE
PROMETHAZI NE HYDROCHLORI DE AND DEXTROMETHORPHAN HYDROBROMI DE, DEXTROMETHORPHAN
PROMETHAZI NE HYDROCHLORI DE AND PHENYLEPHRI NE HYDROCHLORI DE, PHENYLEPHRI NE HYDROCHLORI DE
PROMETHAZI NE PLAI N, PROMETHAZI NE HYDROCHLORI DE
PROMETHAZI NE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMI DE
PROMETHAZI NE WI TH CODEI NE, CODEI NE PHOSPHATE
PROMETHEGAN, PROMETHAZI NE HYDROCHLORI DE
PROMETRI UM, PROGESTERONE
PROPAFENONE HYDROCHLORI DE, PROPAFENONE HYDROCHLORI DE
PROPANTHELI NE BROMI DE, PROPANTHELI NE BROMI DE
PROPARACAI NE HYDROCHLORI DE, PROPARACAI NE HYDROCHLORI DE
PROPECI A, FI NASTERI DE
PROPI NE, DI PI VEFRI N HYDROCHLORI DE
PROPOFOL, PROPOFOL
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
PROPRANOLOL HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
PROPYLTHI OURACI L, PROPYLTHI OURACI L
PROSCAR, FI NASTERI DE
PROSOL 20%SULFI TE FREE I N PLASTI C CONTAI NER, AMI NO ACI DS
PROSTI N E2, DI NOPROSTONE
PROSTI N VR PEDI ATRI C, ALPROSTADI L
PROTAMI NE SULFATE, PROTAMI NE SULFATE
PROTONI X, PANTOPRAZOLE SODI UM
PROTONI X I V, PANTOPRAZOLE SODI UM
PROTOPAM CHLORI DE, PRALI DOXI ME CHLORI DE
PROTOPI C, TACROLI MUS
PROTRI PTYLI NE HYDROCHLORI DE, PROTRI PTYLI NE HYDROCHLORI DE
PROVENTI L- HFA, ALBUTEROL SULFATE
PROVERA, MEDROXYPROGESTERONE ACETATE
PROVI GI L, MODAFI NI L
PROVOCHOLI NE, METHACHOLI NE CHLORI DE
PROZAC, FLUOXETI NE HYDROCHLORI DE
PROZAC WEEKLY, FLUOXETI NE HYDROCHLORI DE
PSEUDOEPHEDRI NE HYDROCHLORI DE, PSEUDOEPHEDRI NE HYDROCHLORI DE ( OTC)
PULMI CORT FLEXHALER, BUDESONI DE
PULMI CORT RESPULES, BUDESONI DE
PULMOLI TE, TECHNETI UM TC- 99M ALBUMI N AGGREGATED KI T
PUR- WASH, PURI FI ED WATER ( OTC)
PURI NETHOL, MERCAPTOPURI NE
PYLERA, BI SMUTH SUBCI TRATE POTASSI UM
PYRAZI NAMI DE, PYRAZI NAMI DE
PYRI DOSTI GMI NE BROMI DE, PYRI DOSTI GMI NE BROMI DE
PYRI DOXI NE HYDROCHLORI DE, PYRI DOXI NE HYDROCHLORI DE
PYTEST, UREA, C- 14
PYTEST KI T, UREA, C- 14
* * Q * *
QNASL, BECLOMETHASONE DI PROPI ONATE
QOLI ANA, BRI MONI DI NE TARTRATE
QSYMI A, PHENTERMI NE HYDROCHLORI DE
QUADRAMET, SAMARI UM SM- 153 LEXI DRONAM PENTASODI UM
QUALAQUI N, QUI NI NE SULFATE
QUARTETTE, ETHI NYL ESTRADI OL
QUASENSE, ETHI NYL ESTRADI OL
QUELI CI N, SUCCI NYLCHOLI NE CHLORI DE
QUELI CI N PRESERVATI VE FREE, SUCCI NYLCHOLI NE CHLORI DE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
QUI LLI VANT XR, METHYLPHENI DATE HYDROCHLORI DE
QUI NAPRI L HYDROCHLORI DE, QUI NAPRI L HYDROCHLORI DE
QUI NAPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
QUI NARETI C, HYDROCHLOROTHI AZI DE
QUI NI DI NE GLUCONATE, QUI NI DI NE GLUCONATE
QUI NI DI NE SULFATE, QUI NI DI NE SULFATE
QUI NI NE SULFATE, QUI NI NE SULFATE
QUI XI N, LEVOFLOXACI N


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 47
APPENDI X A - PRODUCT NAME I NDEX
* * Q * *
QUTENZA, CAPSAI CI N
QVAR 40, BECLOMETHASONE DI PROPI ONATE
QVAR 80, BECLOMETHASONE DI PROPI ONATE
* * R * *
R- GENE 10, ARGI NI NE HYDROCHLORI DE
RABEPRAZOLE SODI UM, RABEPRAZOLE SODI UM
RADI OGARDASE ( PRUSSI AN BLUE) , FERRI C HEXACYANOFERRATE( I I )
RAMELTEON, RAMELTEON
RAMI PRI L, RAMI PRI L
RANEXA, RANOLAZI NE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RANOLAZI NE, RANOLAZI NE
RAPAFLO, SI LODOSI N
RAPAMUNE, SI ROLI MUS
RASAGI LI NE MESYLATE, RASAGI LI NE MESYLATE
RAVI CTI , GLYCEROL PHENYLBUTYRATE
RAYOS, PREDNI SONE
RAZADYNE, GALANTAMI NE HYDROBROMI DE
RAZADYNE ER, GALANTAMI NE HYDROBROMI DE
REBETOL, RI BAVI RI N
RECLAST, ZOLEDRONI C ACI D
RECTI V, NI TROGLYCERI N
REGI TI NE, PHENTOLAMI NE MESYLATE
REGLAN, METOCLOPRAMI DE HYDROCHLORI DE
REGONOL, PYRI DOSTI GMI NE BROMI DE
RELENZA, ZANAMI VI R
RELI STOR, METHYLNALTREXONE BROMI DE
RELPAX, ELETRI PTAN HYDROBROMI DE
REMERON, MI RTAZAPI NE
REMERON SOLTAB, MI RTAZAPI NE
REMODULI N, TREPROSTI NI L
RENACI DI N, CI TRI C ACI D
RENAGEL, SEVELAMER HYDROCHLORI DE
RENAMI N W/ O ELECTROLYTES, AMI NO ACI DS
RENOGRAFI N- 76, DI ATRI ZOATE MEGLUMI NE
RENOVA, TRETI NOI N
RENVELA, SEVELAMER CARBONATE
REPAGLI NI DE, REPAGLI NI DE
REPREXAI N, HYDROCODONE BI TARTRATE
REPRONEX, MENOTROPI NS ( FSH
REQUI P, ROPI NI ROLE HYDROCHLORI DE
REQUI P XL, ROPI NI ROLE HYDROCHLORI DE
RESCRI PTOR, DELAVI RDI NE MESYLATE
RESCULA, UNOPROSTONE I SOPROPYL
RESECTI SOL I N PLASTI C CONTAI NER, MANNI TOL
RESERPI NE, RESERPI NE
RESTASI S, CYCLOSPORI NE
RESTORI L, TEMAZEPAM
RETI N- A, TRETI NOI N
RETI N- A MI CRO, TRETI NOI N
RETI SERT, FLUOCI NOLONE ACETONI DE
RETROVI R, ZI DOVUDI NE
REVATI O, SI LDENAFI L CI TRATE
REVI A, NALTREXONE HYDROCHLORI DE
REVLI MI D, LENALI DOMI DE
REYATAZ, ATAZANAVI R SULFATE
REZI RA, HYDROCODONE BI TARTRATE
RHI NOCORT, BUDESONI DE
RI BASPHERE, RI BAVI RI N
RI BAVARI N, RI BAVI RI N
RI BAVI RI N, RI BAVI RI N
RI D MOUSSE, PI PERONYL BUTOXI DE ( OTC)
RI DAURA, AURANOFI N




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 48
APPENDI X A - PRODUCT NAME I NDEX
* * R * *
RI FADI N, RI FAMPI N
RI FAMATE, I SONI AZI D
RI FAMPI N, RI FAMPI N
RI FATER, I SONI AZI D
RI LUTEK, RI LUZOLE
RI LUZOLE, RI LUZOLE
RI MACTANE, RI FAMPI N
RI MANTADI NE HYDROCHLORI DE, RI MANTADI NE HYDROCHLORI DE
RI MSO- 50, DI METHYL SULFOXI DE
RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
RI OMET, METFORMI N HYDROCHLORI DE
RI SEDRONATE SODI UM, RI SEDRONATE SODI UM
RI SPERDAL, RI SPERI DONE
RI SPERDAL CONSTA, RI SPERI DONE
RI SPERI DONE, RI SPERI DONE
RI TALI N, METHYLPHENI DATE HYDROCHLORI DE
RI TALI N LA, METHYLPHENI DATE HYDROCHLORI DE
RI TALI N- SR, METHYLPHENI DATE HYDROCHLORI DE
RI VASTI GMI NE TARTRATE, RI VASTI GMI NE TARTRATE
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
ROBAXI N, METHOCARBAMOL
ROBAXI N- 750, METHOCARBAMOL
ROBI NUL, GLYCOPYRROLATE
ROBI NUL FORTE, GLYCOPYRROLATE
ROCALTROL, CALCI TRI OL
ROCEPHI N, CEFTRI AXONE SODI UM
ROCURONI UM BROMI DE, ROCURONI UM BROMI DE
ROGAI NE ( FOR MEN) , MI NOXI DI L ( OTC)
ROGAI NE ( FOR WOMEN) , MI NOXI DI L ( OTC)
ROGAI NE EXTRA STRENGTH ( FOR MEN) , MI NOXI DI L ( OTC)
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
ROSI GLI TAZONE MALEATE, ROSI GLI TAZONE MALEATE
ROWASA, MESALAMI NE
ROXI CET, ACETAMI NOPHEN
ROXI CODONE, OXYCODONE HYDROCHLORI DE
ROXI LOX, ACETAMI NOPHEN
ROZEREM, RAMELTEON
RYTHMOL, PROPAFENONE HYDROCHLORI DE
RYTHMOL SR, PROPAFENONE HYDROCHLORI DE
* * S * *
SABRI L, VI GABATRI N
SAFYRAL, DROSPI RENONE
SAI ZEN, SOMATROPI N RECOMBI NANT
SALAGEN, PI LOCARPI NE HYDROCHLORI DE
SALONPAS, MENTHOL ( OTC)
SALURON, HYDROFLUMETHI AZI DE
SAMSCA, TOLVAPTAN
SANCTURA, TROSPI UM CHLORI DE
SANCTURA XR, TROSPI UM CHLORI DE
SANCUSO, GRANI SETRON
SANDI MMUNE, CYCLOSPORI NE
SANDOSTATI N, OCTREOTI DE ACETATE
SANDOSTATI N LAR, OCTREOTI DE ACETATE
SAPHRI S, ASENAPI NE MALEATE
SARAFEM, FLUOXETI NE HYDROCHLORI DE
SAVELLA, MI LNACI PRAN HYDROCHLORI DE
SCANDONEST L, LEVONORDEFRI N
SCANDONEST PLAI N, MEPI VACAI NE HYDROCHLORI DE
SCANLUX- 300, I OPAMI DOL
SCANLUX- 370, I OPAMI DOL
SCLEROSOL, TALC
SEASONALE, ETHI NYL ESTRADI OL
SEASONI QUE, ETHI NYL ESTRADI OL
SECONAL SODI UM, SECOBARBI TAL SODI UM


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 49
APPENDI X A - PRODUCT NAME I NDEX
* * S * *
SECTRAL, ACEBUTOLOL HYDROCHLORI DE
SELEGI LI NE HYDROCHLORI DE, SELEGI LI NE HYDROCHLORI DE
SELENI UM SULFI DE, SELENI UM SULFI DE
SELSUN, SELENI UM SULFI DE
SELZENTRY, MARAVI ROC
SEMPREX- D, ACRI VASTI NE
SENSI PAR, CI NACALCET HYDROCHLORI DE
SENSORCAI NE, BUPI VACAI NE HYDROCHLORI DE
SEPTOCAI NE, ARTI CAI NE HYDROCHLORI DE
SEPTRA, SULFAMETHOXAZOLE
SEPTRA DS, SULFAMETHOXAZOLE
SEREVENT, SALMETEROL XI NAFOATE
SEROMYCI N, CYCLOSERI NE
SEROPHENE, CLOMI PHENE CI TRATE
SEROQUEL, QUETI API NE FUMARATE
SEROQUEL XR, QUETI API NE FUMARATE
SEROSTI M, SOMATROPI N RECOMBI NANT
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SEVOFLURANE, SEVOFLURANE
SFROWASA, MESALAMI NE
SHADE UVAGUARD, AVOBENZONE ( OTC)
SI GNI FOR, PASI REOTI DE DI ASPARTATE
SI LDENAFI L CI TRATE, SI LDENAFI L CI TRATE
SI LENOR, DOXEPI N HYDROCHLORI DE
SI LVADENE, SI LVER SULFADI AZI NE
SI MBRI NZA, BRI MONI DI NE TARTRATE
SI MCOR, NI ACI N
SI MVASTATI N, SI MVASTATI N
SI NE- AI D I B, I BUPROFEN ( OTC)
SI NEMET, CARBI DOPA
SI NEMET CR, CARBI DOPA
SI NGULAI R, MONTELUKAST SODI UM
SI NOGRAFI N, DI ATRI ZOATE MEGLUMI NE
SI ROLI MUS, SI ROLI MUS
SI RTURO, BEDAQUI LI NE FUMARATE
SKELAXI N, METAXALONE
SKLI CE, I VERMECTI N
SKYLA, LEVONORGESTREL
SODI UM ACETATE I N PLASTI C CONTAI NER, SODI UM ACETATE ANHYDROUS
SODI UM BI CARBONATE, SODI UM BI CARBONATE
SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE 0. 9%, SODI UM CHLORI DE
SODI UM CHLORI DE 0. 9%, SODI UM CHLORI DE
SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE 0. 9%I N STERI LE PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE 3%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE 5%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM FERRI C GLUCONATE COMPLEX I N SUCROSE, SODI UM FERRI C GLUCONATE COMPLEX
SODI UM FLUORI DE F- 18, SODI UM FLUORI DE F- 18
SODI UM I ODI DE I 123, SODI UM I ODI DE I - 123
SODI UM I ODI DE I 131, SODI UM I ODI DE I - 131
SODI UM I ODI DE I - 131, SODI UM I ODI DE I - 131
SODI UM LACTATE 0. 167 MOLAR I N PLASTI C CONTAI NER, SODI UM LACTATE
SODI UM LACTATE 1/ 6 MOLAR I N PLASTI C CONTAI NER, SODI UM LACTATE
SODI UM LACTATE I N PLASTI C CONTAI NER, SODI UM LACTATE
SODI UM NI TRI TE, SODI UM NI TRI TE
SODI UM PHENYLBUTYRATE, SODI UM PHENYLBUTYRATE
SODI UM PHOSPHATES I N PLASTI C CONTAI NER, SODI UM PHOSPHATE, DI BASI C, HEPTAHYDRATE
SODI UM POLYSTYRENE SULFONATE, SODI UM POLYSTYRENE SULFONATE
SODI UM THI OSULFATE, SODI UM THI OSULFATE
SOJ OURN, SEVOFLURANE
SOLARAZE, DI CLOFENAC SODI UM
SOLODYN, MI NOCYCLI NE HYDROCHLORI DE
SOLTAMOX, TAMOXI FEN CI TRATE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 50
APPENDI X A - PRODUCT NAME I NDEX
* * S * *
SOLU- CORTEF, HYDROCORTI SONE SODI UM SUCCI NATE
SOLU- MEDROL, METHYLPREDNI SOLONE SODI UM SUCCI NATE
SOMA, CARI SOPRODOL
SOMA COMPOUND, ASPI RI N
SOMA COMPOUND W/ CODEI NE, ASPI RI N
SOMATULI NE DEPOT, LANREOTI DE ACETATE
SOMAVERT, PEGVI SOMANT
SONATA, ZALEPLON
SORBI TOL 3%I N PLASTI C CONTAI NER, SORBI TOL
SORBI TOL 3. 3%I N PLASTI C CONTAI NER, SORBI TOL
SORBI TOL- MANNI TOL I N PLASTI C CONTAI NER, MANNI TOL
SORI ATANE, ACI TRETI N
SORI LUX, CALCI POTRI ENE
SORI NE, SOTALOL HYDROCHLORI DE
SOTALOL HYDROCHLORI DE, SOTALOL HYDROCHLORI DE
SOTRADECOL, SODI UM TETRADECYL SULFATE
SOTRET, I SOTRETI NOI N
SOVALDI , SOFOSBUVI R
SPECTRACEF, CEFDI TOREN PI VOXI L
SPI RI VA, TI OTROPI UM BROMI DE MONOHYDRATE
SPI RONOLACTONE, SPI RONOLACTONE
SPI RONOLACTONE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
SPORANOX, I TRACONAZOLE
SPRI NTEC, ETHI NYL ESTRADI OL
SPRI X, KETOROLAC TROMETHAMI NE
SPRYCEL, DASATI NI B
SPS, SODI UM POLYSTYRENE SULFONATE
SSD, SI LVER SULFADI AZI NE
SSD AF, SI LVER SULFADI AZI NE
STALEVO 100, CARBI DOPA
STALEVO 125, CARBI DOPA
STALEVO 150, CARBI DOPA
STALEVO 200, CARBI DOPA
STALEVO 50, CARBI DOPA
STALEVO 75, CARBI DOPA
STARLI X, NATEGLI NI DE
STAVUDI NE, STAVUDI NE
STAXYN, VARDENAFI L HYDROCHLORI DE
STENDRA, AVANAFI L
STERI LE WATER, STERI LE WATER FOR I RRI GATI ON
STERI LE WATER FOR I NJ ECTI ON I N PLASTI C CONTAI NER, STERI LE WATER FOR I NJ ECTI ON
STERI LE WATER I N PLASTI C CONTAI NER, STERI LE WATER FOR I RRI GATI ON
STI E- CORT, HYDROCORTI SONE
STI MATE ( NEEDS NO REFRI GERATI ON) , DESMOPRESSI N ACETATE
STI VARGA, REGORAFENI B
STRATTERA, ATOMOXETI NE HYDROCHLORI DE
STREPTOMYCI N SULFATE, STREPTOMYCI N SULFATE
STRI ANT, TESTOSTERONE
STRI BI LD, COBI CI STAT
STROMECTOL, I VERMECTI N
STRONTI UM CHLORI DE SR- 89, STRONTI UM CHLORI DE SR- 89
SUBLI MAZE PRESERVATI VE FREE, FENTANYL CI TRATE
SUBOXONE, BUPRENORPHI NE HYDROCHLORI DE
SUBSYS, FENTANYL
SUCLEAR, MAGNESI UM SULFATE
SUCRAI D, SACROSI DASE
SUCRALFATE, SUCRALFATE
SUDAFED 12 HOUR, PSEUDOEPHEDRI NE HYDROCHLORI DE ( OTC)
SUDAFED 24 HOUR, PSEUDOEPHEDRI NE HYDROCHLORI DE ( OTC)
SUFENTA PRESERVATI VE FREE, SUFENTANI L CI TRATE
SUFENTANI L CI TRATE, SUFENTANI L CI TRATE
SULAR, NI SOLDI PI NE
SULFACETAMI DE SODI UM, SULFACETAMI DE SODI UM
SULFACETAMI DE SODI UM AND PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
SULFADI AZI NE, SULFADI AZI NE




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 51
APPENDI X A - PRODUCT NAME I NDEX
* * S * *
SULFAMETHOXAZOLE AND TRI METHOPRI M, SULFAMETHOXAZOLE
SULFAMETHOXAZOLE AND TRI METHOPRI M DOUBLE STRENGTH, SULFAMETHOXAZOLE
SULFAMETHOXAZOLE AND TRI METHOPRI M SI NGLE STRENGTH, SULFAMETHOXAZOLE
SULFAMYLON, MAFENI DE ACETATE
SULFASALAZI NE, SULFASALAZI NE
SULFATRI M PEDI ATRI C, SULFAMETHOXAZOLE
SULI NDAC, SULI NDAC
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
SUMAVEL DOSEPRO, SUMATRI PTAN SUCCI NATE
SUPPRELI N LA, HI STRELI N ACETATE
SUPRANE, DESFLURANE
SUPRAX, CEFI XI ME
SUPRENZA, PHENTERMI NE HYDROCHLORI DE
SUPREP BOWEL PREP KI T, MAGNESI UM SULFATE ANHYDROUS
SURFAXI N, LUCI NACTANT
SURMONTI L, TRI MI PRAMI NE MALEATE
SURVANTA, BERACTANT
SUSTI VA, EFAVI RENZ
SUTENT, SUNI TI NI B MALATE
SYEDA, DROSPI RENONE
SYMBI CORT, BUDESONI DE
SYMBYAX, FLUOXETI NE HYDROCHLORI DE
SYMLI N, PRAMLI NTI DE ACETATE
SYNACORT, HYDROCORTI SONE
SYNALAR, FLUOCI NOLONE ACETONI DE
SYNALGOS- DC, ASPI RI N
SYNAREL, NAFARELI N ACETATE
SYNERA, LI DOCAI NE
SYNERCI D, DALFOPRI STI N
SYNRI BO, OMACETAXI NE MEPESUCCI NATE
SYNTHROI D, LEVOTHYROXI NE SODI UM **
SYPRI NE, TRI ENTI NE HYDROCHLORI DE
* * T * *
TAB- PROFEN, I BUPROFEN ( OTC)
TACLONEX, BETAMETHASONE DI PROPI ONATE
TACROLI MUS, TACROLI MUS
TAFI NLAR, DABRAFENI B MESYLATE
TAGAMET, CI METI DI NE
TAGAMET HB, CI METI DI NE ( OTC)
TALC, TALC
TALWI N, PENTAZOCI NE LACTATE
TAMI FLU, OSELTAMI VI R PHOSPHATE
TAMOXI FEN CI TRATE, TAMOXI FEN CI TRATE
TAMSULOSI N HYDROCHLORI DE, TAMSULOSI N HYDROCHLORI DE
TAPAZOLE, METHI MAZOLE
TARCEVA, ERLOTI NI B HYDROCHLORI DE
TARGRETI N, BEXAROTENE
TARKA, TRANDOLAPRI L
TASI GNA, NI LOTI NI B HYDROCHLORI DE MONOHYDRATE
TASMAR, TOLCAPONE
TAVI ST ALLERGY/ SI NUS/ HEADACHE, ACETAMI NOPHEN ( OTC)
TAVI ST- 1, CLEMASTI NE FUMARATE ( OTC)
TAXOL, PACLI TAXEL
TAXOTERE, DOCETAXEL
TAZI CEF, CEFTAZI DI ME
TAZORAC, TAZAROTENE
TAZTI A XT, DI LTI AZEM HYDROCHLORI DE
TECFI DERA, DI METHYL FUMARATE
TECHNELI TE, TECHNETI UM TC- 99M SODI UM PERTECHNETATE GENERATOR
TECHNESCAN, TECHNETI UM TC- 99M OXI DRONATE KI T
TECHNESCAN MAG3, TECHNETI UM TC- 99M MERTI ATI DE KI T
TECHNESCAN PYP KI T, TECHNETI UM TC- 99M PYROPHOSPHATE KI T
TECHNETI UM TC 99M ALBUMI N AGGREGATED KI T, TECHNETI UM TC- 99M ALBUMI N AGGREGATED KI T
TECHNETI UM TC 99M SESTAMI BI , TECHNETI UM TC- 99M SESTAMI BI KI T


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 52
APPENDI X A - PRODUCT NAME I NDEX
* * T * *
TECHNETI UM TC- 99 SESTAMI BI , TECHNETI UM TC- 99M SESTAMI BI KI T
TECHNETI UM TC- 99M MEBROFENI N, TECHNETI UM TC- 99M MEBROFENI N KI T
TEFLARO, CEFTAROLI NE FOSAMI L
TEGRETOL, CARBAMAZEPI NE
TEGRETOL- XR, CARBAMAZEPI NE
TEKAMLO, ALI SKI REN HEMI FUMARATE
TEKTURNA, ALI SKI REN HEMI FUMARATE
TEKTURNA HCT, ALI SKI REN HEMI FUMARATE
TELMI SARTAN, TELMI SARTAN
TELMI SARTAN AND AMLODI PI NE, AMLODI PI NE BESYLATE
TEMAZEPAM, TEMAZEPAM
TEMODAR, TEMOZOLOMI DE
TEMOVATE, CLOBETASOL PROPI ONATE
TEMOVATE E, CLOBETASOL PROPI ONATE
TEMOZOLOMI DE, TEMOZOLOMI DE
TENEX, GUANFACI NE HYDROCHLORI DE
TENORETI C 100, ATENOLOL
TENORETI C 50, ATENOLOL
TENORMI N, ATENOLOL
TENSI LON, EDROPHONI UM CHLORI DE
TENSI LON PRESERVATI VE FREE, EDROPHONI UM CHLORI DE
TENUATE, DI ETHYLPROPI ON HYDROCHLORI DE
TENUATE DOSPAN, DI ETHYLPROPI ON HYDROCHLORI DE
TERAZOL 3, TERCONAZOLE
TERAZOL 7, TERCONAZOLE
TERAZOSI N HYDROCHLORI DE, TERAZOSI N HYDROCHLORI DE
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE ( OTC)
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
TERBUTALI NE SULFATE, TERBUTALI NE SULFATE
TERCONAZOLE, TERCONAZOLE
TERI L, CARBAMAZEPI NE
TERRAMYCI N W/ POLYMYXI N B SULFATE, OXYTETRACYCLI NE HYDROCHLORI DE
TESSALON, BENZONATATE
TESTI M, TESTOSTERONE
TESTOPEL, TESTOSTERONE
TESTOSTERONE, TESTOSTERONE
TESTOSTERONE CYPI ONATE, TESTOSTERONE CYPI ONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
TESTRED, METHYLTESTOSTERONE
TETRACYCLI NE HYDROCHLORI DE, TETRACYCLI NE HYDROCHLORI DE
TEV- TROPI N, SOMATROPI N RECOMBI NANT
TEVETEN, EPROSARTAN MESYLATE
TEVETEN HCT, EPROSARTAN MESYLATE
TEXACORT, HYDROCORTI SONE
THALI TONE, CHLORTHALI DONE
THALLOUS CHLORI DE TL 201, THALLOUS CHLORI DE TL- 201
THALOMI D, THALI DOMI DE
THAM, TROMETHAMI NE
THEO- 24, THEOPHYLLI NE
THEOCHRON, THEOPHYLLI NE
THEOLAI R, THEOPHYLLI NE
THEOPHYLLI NE, THEOPHYLLI NE
THEOPHYLLI NE 0. 04%AND DEXTROSE 5%I N PLASTI C CONTAI NER, THEOPHYLLI NE
THEOPHYLLI NE 0. 08%AND DEXTROSE 5%I N PLASTI C CONTAI NER, THEOPHYLLI NE
THEOPHYLLI NE 0. 16%AND DEXTROSE 5%I N PLASTI C CONTAI NER, THEOPHYLLI NE
THEOPHYLLI NE 0. 32%AND DEXTROSE 5%I N PLASTI C CONTAI NER, THEOPHYLLI NE
THEOPHYLLI NE I N DEXTROSE 5%I N PLASTI C CONTAI NER, THEOPHYLLI NE
THERMAZENE, SI LVER SULFADI AZI NE
THEROXI DI L, MI NOXI DI L ( OTC)
THI AMI NE HYDROCHLORI DE, THI AMI NE HYDROCHLORI DE
THI OGUANI NE, THI OGUANI NE
THI OLA, TI OPRONI N
THI ORI DAZI NE HYDROCHLORI DE, THI ORI DAZI NE HYDROCHLORI DE
THI OTEPA, THI OTEPA
THI OTHI XENE, THI OTHI XENE





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 53
APPENDI X A - PRODUCT NAME I NDEX
* * T * *
THRI VE, NI COTI NE POLACRI LEX ( OTC)
THYROGEN, THYROTROPI N ALFA
THYROLAR- 0. 25, LI OTRI X ( T4
THYROLAR- 0. 5, LI OTRI X ( T4
THYROLAR- 1, LI OTRI X ( T4
THYROLAR- 2, LI OTRI X ( T4
THYROLAR- 3, LI OTRI X ( T4
THYROSAFE, POTASSI UM I ODI DE ( OTC)
THYROSHI ELD, POTASSI UM I ODI DE ( OTC)
TI AGABI NE HYDROCHLORI DE, TI AGABI NE HYDROCHLORI DE
TI AZAC, DI LTI AZEM HYDROCHLORI DE
TI CLOPI DI NE HYDROCHLORI DE, TI CLOPI DI NE HYDROCHLORI DE
TI GAN, TRI METHOBENZAMI DE HYDROCHLORI DE
TI KOSYN, DOFETI LI DE
TI MENTI N, CLAVULANATE POTASSI UM
TI MENTI N I N PLASTI C CONTAI NER, CLAVULANATE POTASSI UM
TI MOLOL MALEATE, TI MOLOL MALEATE
TI MOPTI C, TI MOLOL MALEATE
TI MOPTI C I N OCUDOSE, TI MOLOL MALEATE
TI MOPTI C- XE, TI MOLOL MALEATE
TI NDAMAX, TI NI DAZOLE
TI NI DAZOLE, TI NI DAZOLE
TI OCONAZOLE, TI OCONAZOLE ( OTC)
TI ROSI NT, LEVOTHYROXI NE SODI UM
TI S- U- SOL, MAGNESI UM SULFATE
TI S- U- SOL I N PLASTI C CONTAI NER, MAGNESI UM SULFATE
TI VI CAY, DOLUTEGRAVI R SODI UM
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
TOBI , TOBRAMYCI N
TOBI PODHALER, TOBRAMYCI N
TOBRADEX, DEXAMETHASONE
TOBRADEX ST, DEXAMETHASONE
TOBRAMYCI N, TOBRAMYCI N
TOBRAMYCI N AND DEXAMETHASONE, DEXAMETHASONE
TOBRAMYCI N SULFATE, TOBRAMYCI N SULFATE
TOBRAMYCI N SULFATE ( PHARMACY BULK) , TOBRAMYCI N SULFATE
TOBRAMYCI N SULFATE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, TOBRAMYCI N SULFATE
TOBREX, TOBRAMYCI N
TODAY, NONOXYNOL- 9 ( OTC)
TOFRANI L, I MI PRAMI NE HYDROCHLORI DE
TOFRANI L- PM, I MI PRAMI NE PAMOATE
TOLAZAMI DE, TOLAZAMI DE
TOLBUTAMI DE, TOLBUTAMI DE
TOLMETI N SODI UM, TOLMETI N SODI UM
TOLTERODI NE TARTRATE, TOLTERODI NE TARTRATE
TOPAMAX, TOPI RAMATE
TOPI CORT, DESOXI METASONE
TOPI RAMATE, TOPI RAMATE
TOPI RAMATE , TOPI RAMATE
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
TOPROL- XL, METOPROLOL SUCCI NATE
TORI SEL, TEMSI ROLI MUS
TORSEMI DE, TORSEMI DE
TOTECT, DEXRAZOXANE HYDROCHLORI DE
TOVI AZ, FESOTERODI NE FUMARATE
TPN ELECTROLYTES I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
TRACLEER, BOSENTAN
TRADJ ENTA, LI NAGLI PTI N
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
TRAMADOL HYDROCHLORI DE AND ACETAMI NOPHEN, ACETAMI NOPHEN
TRANDOLAPRI L, TRANDOLAPRI L
TRANDOLAPRI L AND VERAPAMI L HYDROCHLORI DE, TRANDOLAPRI L
TRANEXAMI C ACI D, TRANEXAMI C ACI D
TRANSDERM SCOP, SCOPOLAMI NE
TRANXENE, CLORAZEPATE DI POTASSI UM

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 54
APPENDI X A - PRODUCT NAME I NDEX
* * T * *
TRANYLCYPROMI NE SULFATE, TRANYLCYPROMI NE SULFATE
TRAVASOL 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 10%W/ O ELECTROLYTES, AMI NO ACI DS
TRAVASOL 3. 5%SULFI TE FREE W/ ELECTROLYTES I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 3. 5%W/ ELECTROLYTES, AMI NO ACI DS
TRAVASOL 5. 5%I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 5. 5%SULFI TE FREE W/ ELECTROLYTES I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 5. 5%W/ ELECTROLYTES, AMI NO ACI DS
TRAVASOL 5. 5%W/ O ELECTROLYTES, AMI NO ACI DS
TRAVASOL 8. 5%I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 8. 5%SULFI TE FREE W/ ELECTROLYTES I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 8. 5%W/ ELECTROLYTES, AMI NO ACI DS
TRAVASOL 8. 5%W/ O ELECTROLYTES, AMI NO ACI DS
TRAVATAN Z, TRAVOPROST
TRAVOPROST, TRAVOPROST
TRAZODONE HYDROCHLORI DE, TRAZODONE HYDROCHLORI DE
TREANDA, BENDAMUSTI NE HYDROCHLORI DE
TRECATOR, ETHI ONAMI DE
TRELSTAR, TRI PTORELI N PAMOATE
TRENTAL, PENTOXI FYLLI NE
TRETI NOI N, TRETI NOI N
TREXALL, METHOTREXATE SODI UM
TREXI MET, NAPROXEN SODI UM
TRI - ESTARYLLA, ETHI NYL ESTRADI OL
TRI - LEGEST 21, ETHI NYL ESTRADI OL
TRI - LEGEST FE, ETHI NYL ESTRADI OL
TRI - LI NYAH, ETHI NYL ESTRADI OL
TRI - LUMA, FLUOCI NOLONE ACETONI DE
TRI - NORI NYL 28- DAY, ETHI NYL ESTRADI OL
TRI - PREVI FEM, ETHI NYL ESTRADI OL
TRI - SPRI NTEC, ETHI NYL ESTRADI OL
TRI ACI N- C, CODEI NE PHOSPHATE
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
TRI AMCI NOLONE ACETONI DE I N ABSORBASE, TRI AMCI NOLONE ACETONI DE
TRI AMTERENE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
TRI AZOLAM, TRI AZOLAM
TRI BENZOR, AMLODI PI NE BESYLATE
TRI COR, FENOFI BRATE
TRI DERM, TRI AMCI NOLONE ACETONI DE
TRI DI ONE, TRI METHADI ONE
TRI ESENCE, TRI AMCI NOLONE ACETONI DE
TRI FLUOPERAZI NE HYDROCHLORI DE, TRI FLUOPERAZI NE HYDROCHLORI DE
TRI FLURI DI NE, TRI FLURI DI NE
TRI GLI DE, FENOFI BRATE
TRI HEXYPHENI DYL HYDROCHLORI DE, TRI HEXYPHENI DYL HYDROCHLORI DE
TRI LEPTAL, OXCARBAZEPI NE
TRI LI PI X, CHOLI NE FENOFI BRATE
TRI LYTE, POLYETHYLENE GLYCOL 3350
TRI METHOBENZAMI DE HYDROCHLORI DE, TRI METHOBENZAMI DE HYDROCHLORI DE
TRI METHOBENZAMI DE HYDROCHLORI DE PRESERVATI VE FREE, TRI METHOBENZAMI DE HYDROCHLORI DE
TRI METHOPRI M, TRI METHOPRI M
TRI METHOPRI M SULFATE AND POLYMYXI N B SULFATE, POLYMYXI N B SULFATE
TRI MI PRAMI NE MALEATE, TRI MI PRAMI NE MALEATE
TRI OSTAT, LI OTHYRONI NE SODI UM
TRI SENOX, ARSENI C TRI OXI DE
TRI VAGI ZOLE 3, CLOTRI MAZOLE ( OTC)
TRI VORA- 28, ETHI NYL ESTRADI OL
TRI ZI VI R, ABACAVI R SULFATE
TROKENDI XR, TOPI RAMATE
TROPHAMI NE, AMI NO ACI DS
TROPHAMI NE 10%, AMI NO ACI DS
TROPI CACYL, TROPI CAMI DE
TROPI CAMI DE, TROPI CAMI DE
TROSPI UM CHLORI DE, TROSPI UM CHLORI DE
TRUSOPT, DORZOLAMI DE HYDROCHLORI DE



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 55
APPENDI X A - PRODUCT NAME I NDEX
* * T * *
TRUVADA, EMTRI CI TABI NE
TUDORZA PRESSAI R, ACLI DI NI UM BROMI DE
TUSSI CAPS, CHLORPHENI RAMI NE POLI STI REX
TUSSI GON, HOMATROPI NE METHYLBROMI DE
TUSSI ONEX PENNKI NETI C, CHLORPHENI RAMI NE POLI STI REX
TWI NJ ECT 0. 15, EPI NEPHRI NE
TWI NJ ECT 0. 3, EPI NEPHRI NE
TWYNSTA, AMLODI PI NE BESYLATE
TYGACI L, TI GECYCLI NE
TYKERB, LAPATI NI B DI TOSYLATE
TYLENOL , ACETAMI NOPHEN ( OTC)
TYLENOL W/ CODEI NE NO. 3, ACETAMI NOPHEN
TYLENOL W/ CODEI NE NO. 4, ACETAMI NOPHEN
TYLOX, ACETAMI NOPHEN
TYVASO, TREPROSTI NI L
TYZEKA, TELBI VUDI NE
TYZI NE, TETRAHYDROZOLI NE HYDROCHLORI DE
* * U * *
U- CORT, HYDROCORTI SONE ACETATE
UCERI S, BUDESONI DE
ULESFI A, BENZYL ALCOHOL
ULORI C, FEBUXOSTAT
ULTANE, SEVOFLURANE
ULTI VA, REMI FENTANI L HYDROCHLORI DE
ULTRA- TECHNEKOWFM, TECHNETI UM TC- 99M SODI UM PERTECHNETATE GENERATOR
ULTRACET, ACETAMI NOPHEN
ULTRAM, TRAMADOL HYDROCHLORI DE
ULTRAM ER, TRAMADOL HYDROCHLORI DE
ULTRATAG, TECHNETI UM TC- 99M RED BLOOD CELL KI T
ULTRAVATE, HALOBETASOL PROPI ONATE
ULTRAVI ST ( PHARMACY BULK) , I OPROMI DE
ULTRAVI ST 150, I OPROMI DE
ULTRAVI ST 240, I OPROMI DE
ULTRAVI ST 300, I OPROMI DE
ULTRAVI ST 300 I N PLASTI C CONTAI NER, I OPROMI DE
ULTRAVI ST 370, I OPROMI DE
ULTRESA, PANCRELI PASE ( AMYLASE
UNASYN, AMPI CI LLI N SODI UM
UNI PHYL, THEOPHYLLI NE
UNI RETI C, HYDROCHLOROTHI AZI DE
UNI SOM, DOXYLAMI NE SUCCI NATE ( OTC)
UNI THROI D, LEVOTHYROXI NE SODI UM **
UNI VASC, MOEXI PRI L HYDROCHLORI DE
URECHOLI NE, BETHANECHOL CHLORI DE
UREX, METHENAMI NE HI PPURATE
UROCI T- K, POTASSI UM CI TRATE
UROXATRAL, ALFUZOSI N HYDROCHLORI DE
URSO 250, URSODI OL
URSO FORTE, URSODI OL
URSODI OL, URSODI OL
UVADEX, METHOXSALEN
* * V * *
VAGI FEM, ESTRADI OL
VAGI STAT- 1, TI OCONAZOLE ( OTC)
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
VALCHLOR, MECHLORETHAMI NE HYDROCHLORI DE
VALCYTE, VALGANCI CLOVI R HYDROCHLORI DE
VALI UM, DI AZEPAM
VALNAC, BETAMETHASONE VALERATE
VALPROATE SODI UM, VALPROATE SODI UM
VALPROI C ACI D, VALPROI C ACI D
VALSARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
VALSTAR PRESERVATI VE FREE, VALRUBI CI N
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 56
APPENDI X A - PRODUCT NAME I NDEX
* * V * *
VALTREX, VALACYCLOVI R HYDROCHLORI DE
VALTROPI N, SOMATROPI N RECOMBI NANT
VALTURNA, ALI SKI REN HEMI FUMARATE
VANCOCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
VANCOCI N HYDROCHLORI DE I N PLASTI C CONTAI NER, VANCOMYCI N HYDROCHLORI DE
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
VANDAZOLE, METRONI DAZOLE
VANI QA, EFLORNI THI NE HYDROCHLORI DE
VANOS, FLUOCI NONI DE
VANTAS, HI STRELI N ACETATE
VAPRI SOL I N 5%DEXTROSE I N PLASTI C CONTAI NER, CONI VAPTAN HYDROCHLORI DE
VARDENAFI L HYDROCHLORI DE, VARDENAFI L HYDROCHLORI DE
VARI THENA, POLI DOCANOL
VASCEPA, I COSAPENT ETHYL
VASERETI C, ENALAPRI L MALEATE
VASOCI DI N, PREDNI SOLONE SODI UM PHOSPHATE
VASOTEC, ENALAPRI L MALEATE
VECTI CAL, CALCI TRI OL
VECURONI UM BROMI DE, VECURONI UM BROMI DE
VELCADE, BORTEZOMI B
VELETRI , EPOPROSTENOL SODI UM
VELI VET, DESOGESTREL
VELPHORO, SUCROFERRI C OXYHYDROXI DE
VELTI N, CLI NDAMYCI N PHOSPHATE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
VENOFER, I RON SUCROSE
VENTAVI S, I LOPROST
VENTOLI N HFA, ALBUTEROL SULFATE
VERAMYST, FLUTI CASONE FUROATE
VERAPAMI L HYDROCHLORI DE, VERAPAMI L HYDROCHLORI DE
VERDESO, DESONI DE
VEREGEN, SI NECATECHI NS
VERELAN, VERAPAMI L HYDROCHLORI DE
VERELAN PM, VERAPAMI L HYDROCHLORI DE
VERSACLOZ, CLOZAPI NE
VESI CARE, SOLI FENACI N SUCCI NATE
VEXOL, RI MEXOLONE
VFEND, VORI CONAZOLE
VI AGRA, SI LDENAFI L CI TRATE
VI BATI V, TELAVANCI N HYDROCHLORI DE
VI BI SONE, CYANOCOBALAMI N
VI BRAMYCI N, DOXYCYCLI NE
VI BRAMYCI N, DOXYCYCLI NE CALCI UM
VI BRAMYCI N, DOXYCYCLI NE HYCLATE
VI COPROFEN, HYDROCODONE BI TARTRATE
VI CTOZA, LI RAGLUTI DE RECOMBI NANT
VI CTRELI S, BOCEPREVI R
VI DAZA, AZACI TI DI NE
VI DEX, DI DANOSI NE
VI DEX EC, DI DANOSI NE
VI GAMOX, MOXI FLOXACI N HYDROCHLORI DE
VI I BRYD, VI LAZODONE HYDROCHLORI DE
VI MOVO, ESOMEPRAZOLE MAGNESI UM
VI MPAT, LACOSAMI DE
VI NBLASTI NE SULFATE, VI NBLASTI NE SULFATE
VI NCRI STI NE SULFATE PFS, VI NCRI STI NE SULFATE
VI NORELBI NE, VI NORELBI NE
VI NORELBI NE TARTRATE, VI NORELBI NE TARTRATE
VI OKACE, PANCRELI PASE ( AMYLASE
VI ORELE, DESOGESTREL
VI RACEPT, NELFI NAVI R MESYLATE
VI RAMUNE, NEVI RAPI NE
VI RAMUNE XR, NEVI RAPI NE
VI RAZOLE, RI BAVI RI N
VI READ, TENOFOVI R DI SOPROXI L FUMARATE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 57
APPENDI X A - PRODUCT NAME I NDEX
* * V * *
VI ROPTI C, TRI FLURI DI NE
VI SI NE L. R. , OXYMETAZOLI NE HYDROCHLORI DE ( OTC)
VI SI NE- A, NAPHAZOLI NE HYDROCHLORI DE ( OTC)
VI SI ONBLUE, TRYPAN BLUE
VI SI PAQUE 270, I ODI XANOL
VI SI PAQUE 320, I ODI XANOL
VI STARI L, HYDROXYZI NE PAMOATE
VI STI DE, CI DOFOVI R
VI SUDYNE, VERTEPORFI N
VI TAMI N D, ERGOCALCI FEROL
VI TAMI N K1, PHYTONADI ONE
VI TRASE, HYALURONI DASE
VI TUZ, CHLORPHENI RAMI NE MALEATE
VI VACTI L, PROTRI PTYLI NE HYDROCHLORI DE
VI VELLE, ESTRADI OL
VI VELLE- DOT, ESTRADI OL
VI VI TROL, NALTREXONE
VI ZAMYL, FLUTEMETAMOL F- 18
VOLTAREN, DI CLOFENAC SODI UM
VOLTAREN- XR, DI CLOFENAC SODI UM
VORI CONAZOLE, VORI CONAZOLE
VOSOL, ACETI C ACI D, GLACI AL
VOSOL HC, ACETI C ACI D, GLACI AL
VOSPI RE ER, ALBUTEROL SULFATE
VOTRI ENT, PAZOPANI B HYDROCHLORI DE
VPRI V, VELAGLUCERASE ALFA
VUMON, TENI POSI DE
VUSI ON, MI CONAZOLE NI TRATE
VYFEMLA, ETHI NYL ESTRADI OL
VYTORI N, EZETI MI BE
VYVANSE, LI SDEXAMFETAMI NE DI MESYLATE
* * W * *
WARFARI N SODI UM, WARFARI N SODI UM
WELCHOL, COLESEVELAM HYDROCHLORI DE
WELLBUTRI N, BUPROPI ON HYDROCHLORI DE
WELLBUTRI N SR, BUPROPI ON HYDROCHLORI DE
WELLBUTRI N XL, BUPROPI ON HYDROCHLORI DE
WERA, ETHI NYL ESTRADI OL
* * X * *
XALATAN, LATANOPROST
XALKORI , CRI ZOTI NI B
XANAX, ALPRAZOLAM
XANAX XR, ALPRAZOLAM
XARELTO, RI VAROXABAN
XELJ ANZ, TOFACI TI NI B CI TRATE
XELODA, CAPECI TABI NE
XENAZI NE, TETRABENAZI NE
XENI CAL, ORLI STAT
XENON XE 133, XENON XE- 133
XERESE, ACYCLOVI R
XI FAXAN, RI FAXI MI N
XOFI GO, RADI UM RA- 223 DI CHLORI DE
XOLEGEL, KETOCONAZOLE
XOPENEX, LEVALBUTEROL HYDROCHLORI DE
XOPENEX HFA, LEVALBUTEROL TARTRATE
XTANDI , ENZALUTAMI DE
XYLOCAI NE, LI DOCAI NE HYDROCHLORI DE
XYLOCAI NE 4%PRESERVATI VE FREE, LI DOCAI NE HYDROCHLORI DE
XYLOCAI NE PRESERVATI VE FREE, LI DOCAI NE HYDROCHLORI DE
XYLOCAI NE VI SCOUS, LI DOCAI NE HYDROCHLORI DE
XYLOCAI NE W/ EPI NEPHRI NE, EPI NEPHRI NE
XYREM, SODI UM OXYBATE
XYZAL, LEVOCETI RI ZI NE DI HYDROCHLORI DE




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 58
APPENDI X A - PRODUCT NAME I NDEX
* * Y * *
YASMI N, DROSPI RENONE
YAZ, DROSPI RENONE
* * Z * *
ZADI TOR, KETOTI FEN FUMARATE ( OTC)
ZAFI RLUKAST, ZAFI RLUKAST
ZALEPLON, ZALEPLON
ZANAFLEX, TI ZANI DI NE HYDROCHLORI DE
ZANOSAR, STREPTOZOCI N
ZANTAC, RANI TI DI NE HYDROCHLORI DE
ZANTAC 150, RANI TI DI NE HYDROCHLORI DE ( OTC)
ZANTAC 150, RANI TI DI NE HYDROCHLORI DE
ZANTAC 25, RANI TI DI NE HYDROCHLORI DE
ZANTAC 300, RANI TI DI NE HYDROCHLORI DE
ZANTAC 75, RANI TI DI NE HYDROCHLORI DE ( OTC)
ZARONTI N, ETHOSUXI MI DE
ZAROXOLYN, METOLAZONE
ZAVESCA, MI GLUSTAT
ZEBETA, BI SOPROLOL FUMARATE
ZECUI TY, SUMATRI PTAN SUCCI NATE
ZEGERI D, OMEPRAZOLE
ZEGERI D OTC, OMEPRAZOLE ( OTC)
ZELAPAR, SELEGI LI NE HYDROCHLORI DE
ZELBORAF, VEMURAFENI B
ZEMPLAR, PARI CALCI TOL
ZEMURON, ROCURONI UM BROMI DE
ZENATANE, I SOTRETI NOI N
ZENPEP, PANCRELI PASE ( AMYLASE
ZERI T, STAVUDI NE
ZESTORETI C, HYDROCHLOROTHI AZI DE
ZESTRI L, LI SI NOPRI L
ZETI A, EZETI MI BE
ZETONNA, CI CLESONI DE
ZI AC, BI SOPROLOL FUMARATE
ZI AGEN, ABACAVI R SULFATE
ZI ANA, CLI NDAMYCI N PHOSPHATE
ZI DOVUDI NE, ZI DOVUDI NE
ZI NACEF, CEFUROXI ME SODI UM
ZI NACEF I N PLASTI C CONTAI NER, CEFUROXI ME SODI UM
ZI NC CHLORI DE I N PLASTI C CONTAI NER, ZI NC CHLORI DE
ZI NECARD, DEXRAZOXANE HYDROCHLORI DE
ZI OPTAN, TAFLUPROST
ZI PRASI DONE HYDROCHLORI DE, ZI PRASI DONE HYDROCHLORI DE
ZI PSOR, DI CLOFENAC POTASSI UM
ZI RGAN, GANCI CLOVI R
ZI THROMAX, AZI THROMYCI N
ZMAX, AZI THROMYCI N
ZOCOR, SI MVASTATI N
ZOFRAN, ONDANSETRON HYDROCHLORI DE
ZOFRAN ODT, ONDANSETRON
ZOFRAN PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ZOHYDRO ER, HYDROCODONE BI TARTRATE
ZOLADEX, GOSERELI N ACETATE
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
ZOLI NZA, VORI NOSTAT
ZOLMI TRI PTAN, ZOLMI TRI PTAN
ZOLOFT, SERTRALI NE HYDROCHLORI DE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
ZOLPI MI ST, ZOLPI DEM TARTRATE
ZOMETA, ZOLEDRONI C ACI D
ZOMI G, ZOLMI TRI PTAN
ZOMI G- ZMT, ZOLMI TRI PTAN
ZONALON, DOXEPI N HYDROCHLORI DE
ZONEGRAN, ZONI SAMI DE
ZONI SAMI DE, ZONI SAMI DE



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
A - 59
APPENDI X A - PRODUCT NAME I NDEX
* * Z * *
ZORBTI VE, SOMATROPI N RECOMBI NANT
ZORTRESS, EVEROLI MUS
ZORVOLEX, DI CLOFENAC
ZOSYN, PI PERACI LLI N SODI UM
ZOSYN I N PLASTI C CONTAI NER, PI PERACI LLI N SODI UM
ZOVI A 1/ 35E- 28, ETHI NYL ESTRADI OL
ZOVI A 1/ 50E- 28, ETHI NYL ESTRADI OL
ZOVI RAX, ACYCLOVI R
ZUBSOLV, BUPRENORPHI NE HYDROCHLORI DE
ZUPLENZ, ONDANSETRON
ZUTRI PRO, CHLORPHENI RAMI NE MALEATE
ZYBAN, BUPROPI ON HYDROCHLORI DE
ZYCLARA, I MI QUI MOD
ZYDONE, ACETAMI NOPHEN
ZYFLO, ZI LEUTON
ZYFLO CR, ZI LEUTON
ZYLET, LOTEPREDNOL ETABONATE
ZYLOPRI M, ALLOPURI NOL
ZYMAR, GATI FLOXACI N
ZYMAXI D, GATI FLOXACI N
ZYPREXA, OLANZAPI NE
ZYPREXA RELPREVV, OLANZAPI NE PAMOATE
ZYPREXA ZYDI S, OLANZAPI NE
ZYRTEC, CETI RI ZI NE HYDROCHLORI DE
ZYRTEC ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
ZYRTEC HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
ZYRTEC- D 12 HOUR, CETI RI ZI NE HYDROCHLORI DE ( OTC)
ZYTI GA, ABI RATERONE ACETATE
ZYVOX, LI NEZOLI D


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 1
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * 3 * *
3 M
* 3M CO
PERI DEX, CHLORHEXI DI NE GLUCONATE
* 3M HEALTH CARE I NC
AVAGARD, ALCOHOL ( OTC)
DURAPREP, I ODI NE POVACRYLEX ( OTC)
* 3M PHARMACEUTI CALS I NC
PROVENTI L- HFA, ALBUTEROL SULFATE
* * A * *
AAI PHARMA LLC
* AAI PHARMA LLC
AZASAN, AZATHI OPRI NE
ABBOTT
* ABBOTT LABORATORI ES PHARMACEUTI CAL PRODUCTS DI V
HYTRI N, TERAZOSI N HYDROCHLORI DE
ABBVI E
* ABBVI E I NC
ADVI COR, LOVASTATI N
AKI NETON, BI PERI DEN HYDROCHLORI DE
ANDROGEL, TESTOSTERONE
BI AXI N XL, CLARI THROMYCI N
BI AXI N, CLARI THROMYCI N
CALCI J EX, CALCI TRI OL
CREON, PANCRELI PASE ( AMYLASE
CYCLOSPORI NE, CYCLOSPORI NE
DEPACON, VALPROATE SODI UM
DEPAKENE, VALPROI C ACI D
DEPAKOTE ER, DI VALPROEX SODI UM
DEPAKOTE, DI VALPROEX SODI UM
GENGRAF, CYCLOSPORI NE
K- TAB, POTASSI UM CHLORI DE
KALETRA, LOPI NAVI R
MARI NOL, DRONABI NOL
MAVI K, TRANDOLAPRI L
NI ASPAN, NI ACI N
NI MBEX PRESERVATI VE FREE, CI SATRACURI UM BESYLATE
NI MBEX, CI SATRACURI UM BESYLATE
NORVI R, RI TONAVI R
ORETI C, HYDROCHLOROTHI AZI DE
SI MCOR, NI ACI N
SURVANTA, BERACTANT
SYNTHROI D, LEVOTHYROXI NE SODI UM **
TARKA, TRANDOLAPRI L
TEVETEN HCT, EPROSARTAN MESYLATE
TEVETEN, EPROSARTAN MESYLATE
TRI COR, FENOFI BRATE
TRI DI ONE, TRI METHADI ONE
TRI LI PI X, CHOLI NE FENOFI BRATE
ULTANE, SEVOFLURANE
VI COPROFEN, HYDROCODONE BI TARTRATE
ZEMPLAR, PARI CALCI TOL
ABBVI E ENDOCRI NE
* ABBVI E ENDOCRI NE I NC
LUPANETA PACK, LEUPROLI DE ACETATE
ABBVI E ENDOCRI NE I NC
* ABBVI E ENDOCRI NE I NC
LUPRON DEPOT, LEUPROLI DE ACETATE
LUPRON DEPOT- PED, LEUPROLI DE ACETATE
ABBVI E I NC
* ABBVI E I NC
PROMETRI UM, PROGESTERONE
ABRAXI S BI OSCI ENCE
* ABRAXI S BI OSCI ENCE LLC
ABRAXANE, PACLI TAXEL
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 2
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
ABRAXI S PHARM
* ABRAXI S PHARMACEUTI CAL PRODUCTS
CLI NDAMYCI N PHOSPHATE I N DEXTROSE 5%, CLI NDAMYCI N PHOSPHATE
ACADEMI C PHARMS
* ACADEMI C PHARMACEUTI CALS I NC
SOTALOL HYDROCHLORI DE, SOTALOL HYDROCHLORI DE
ACCELRX LABS
* ACCELRX LABS LLC
CARI SOPRODOL, CARI SOPRODOL
ACCORD HLTHCARE
* ACCORD HEALTHCARE I NC
ALLOPURI NOL, ALLOPURI NOL
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
ANASTROZOLE, ANASTROZOLE
BI CALUTAMI DE, BI CALUTAMI DE
CARBI DOPA AND LEVODOPA, CARBI DOPA
CLONAZEPAM, CLONAZEPAM
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
DOCETAXEL, DOCETAXEL
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
ETOPOSI DE, ETOPOSI DE
FI NASTERI DE, FI NASTERI DE
FLUOROURACI L, FLUOROURACI L
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
GLI MEPI RI DE, GLI MEPI RI DE
GLI PI ZI DE, GLI PI ZI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
LETROZOLE, LETROZOLE
LEVETI RACETAM, LEVETI RACETAM
LI SI NOPRI L, LI SI NOPRI L
METHOTREXATE SODI UM PRESERVATI VE FREE, METHOTREXATE SODI UM
METHYLDOPA, METHYLDOPA
MI TOMYCI N, MI TOMYCI N
MONTELUKAST SODI UM, MONTELUKAST SODI UM
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
NALTREXONE HYDROCHLORI DE, NALTREXONE HYDROCHLORI DE
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
SI MVASTATI N, SI MVASTATI N
TACROLI MUS, TACROLI MUS
TOPI RAMATE, TOPI RAMATE
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
ACCORD HLTHCARE I NC
* ACCORD HEALTHCARE I NC USA
FI NASTERI DE, FI NASTERI DE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
ACELLA PHARMS LLC
* ACELLA PHARMACEUTI CALS LLC
GABAPENTI N, GABAPENTI N
ACORDA
* ACORDA THERAPEUTI CS I NC
AMPYRA, DALFAMPRI DI NE
QUTENZA, CAPSAI CI N
ZANAFLEX, TI ZANI DI NE HYDROCHLORI DE
ACS DOBFAR
* ACS DOBFAR SPA
AMPI CI LLI N AND SULBACTAM, AMPI CI LLI N SODI UM
CEFAZOLI N SODI UM, CEFAZOLI N SODI UM
CEFEPI ME HYDROCHLORI DE, CEFEPI ME HYDROCHLORI DE
CEFOXI TI N, CEFOXI TI N SODI UM
CEFTAZI DI ME, CEFTAZI DI ME
CEFTRI AXONE, CEFTRI AXONE SODI UM
I MI PENEM AND CI LASTATI N, CI LASTATI N SODI UM
KEFZOL, CEFAZOLI N SODI UM
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 3
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* ACS DOBFAR SPA
MEROPENEM, MEROPENEM
ACS DOBFAR I NFO SA
* ACS DOBFAR I NFO SA
CI PROFLOXACI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, CI PROFLOXACI N
FLUCANAZOLE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, FLUCONAZOLE
LEVOFLOXACI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, LEVOFLOXACI N
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
ACS DOBFAR SPA
* ACS DOBFAR SPA
AMPI CI LLI N SODI UM, AMPI CI LLI N SODI UM
ACTAVI S
* ACTAVI S SOUTHATLANTI C LLC
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
ACTAVI S ELI ZABETH
* ACTAVI S ELI ZABETH LLC
ALPRAZOLAM, ALPRAZOLAM
BUPRENORPHI NE HYDROCHLORI DE AND NALOXONE HYDROCHLORI DE, BUPRENORPHI NE HYDROCHLORI DE
CARBI DOPA AND LEVODOPA, CARBI DOPA
CLONAZEPAM, CLONAZEPAM
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMI NE
DEXTROAMPHETAMI NE SULFATE, DEXTROAMPHETAMI NE SULFATE
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
DOXEPI N HYDROCHLORI DE, DOXEPI N HYDROCHLORI DE
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
DULOXETI NE HYDROCHLORI DE, DULOXETI NE HYDROCHLORI DE
FLUVOXAMI NE MALEATE, FLUVOXAMI NE MALEATE
GABAPENTI N, GABAPENTI N
GLYBURI DE AND METFORMI N HYDROCHLORI DE, GLYBURI DE
GUANFACI NE HYDROCHLORI DE, GUANFACI NE HYDROCHLORI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I NDAPAMI DE, I NDAPAMI DE
I SOSORBI DE MONONI TRATE, I SOSORBI DE MONONI TRATE
LAMOTRI GI NE, LAMOTRI GI NE
LEVETI RACETAM, LEVETI RACETAM
LOVASTATI N, LOVASTATI N
MORPHI NE SULFATE, MORPHI NE SULFATE
NI FEDI PI NE, NI FEDI PI NE
OXAZEPAM, OXAZEPAM
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
OXYCODONE HYDROCHLORI DE AND I BUPROFEN, I BUPROFEN
OXYMORPHONE HYDROCHLORI DE, OXYMORPHONE HYDROCHLORI DE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
PROPYLTHI OURACI L, PROPYLTHI OURACI L
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
SPI RONOLACTONE, SPI RONOLACTONE
TEMAZEPAM, TEMAZEPAM
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
ACTAVI S GRP PTC
* ACTAVI S GROUP PTC EHF
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
SI LDENAFI L CI TRATE, SI LDENAFI L CI TRATE
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
ACTAVI S I NC
* ACTAVI S I NC
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
DOCETAXEL, DOCETAXEL
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
ACTAVI S MI D ATLANTI C
* ACTAVI S MI D ATLANTI C LLC
ACETASOL HC, ACETI C ACI D, GLACI AL








34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 4
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* ACTAVI S MI D ATLANTI C LLC
ACYCLOVI R, ACYCLOVI R
ALBUTEROL SULFATE, ALBUTEROL SULFATE
BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CI CLOPI ROX, CI CLOPI ROX
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
CLOTRI MAZOLE AND BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
CLOTRI MAZOLE, CLOTRI MAZOLE ( OTC)
CONSTULOSE, LACTULOSE
ENULOSE, LACTULOSE
FEXOFENADI NE HYDROCHLORI DE, FEXOFENADI NE HYDROCHLORI DE
FLUOCI NONI DE, FLUOCI NONI DE
GRI SEOFULVI N, GRI SEOFULVI N, MI CROSI ZE
HYDROCODONE BI TARTRATE AND HOMATROPI NE METHYLBROMI DE, HOMATROPI NE METHYLBROMI DE
HYDROCORTI SONE, HYDROCORTI SONE
I BUPROFEN, I BUPROFEN
I BUPROFEN, I BUPROFEN ( OTC)
LEVETI RACETAM, LEVETI RACETAM
M- ZOLE 3 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MI CONAZOLE 7, MI CONAZOLE NI TRATE ( OTC)
MI CONAZOLE NI TRATE, MI CONAZOLE NI TRATE
MI CONAZOLE NI TRATE, MI CONAZOLE NI TRATE ( OTC)
MI NOXI DI L ( FOR MEN) , MI NOXI DI L ( OTC)
MI NOXI DI L EXTRA STRENGTH ( FOR MEN) , MI NOXI DI L ( OTC)
NYSTATI N, NYSTATI N
PERMETHRI N, PERMETHRI N
PERMETHRI N, PERMETHRI N ( OTC)
PROMETH VC PLAI N, PHENYLEPHRI NE HYDROCHLORI DE
PROMETH VC W/ CODEI NE, CODEI NE PHOSPHATE
PROMETH W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMI DE
PROMETHAZI NE HYDROCHLORI DE AND CODEI NE PHOSPHATE, CODEI NE PHOSPHATE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
VALNAC, BETAMETHASONE VALERATE
ACTAVI S TOTOWA
* ACTAVI S TOTOWA LLC
BI CALUTAMI DE, BI CALUTAMI DE
CARBOPLATI N, CARBOPLATI N
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
DESI PRAMI NE HYDROCHLORI DE, DESI PRAMI NE HYDROCHLORI DE
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
FI NASTERI DE, FI NASTERI DE
FLUDARABI NE PHOSPHATE, FLUDARABI NE PHOSPHATE
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
LAMOTRI GI NE, LAMOTRI GI NE
LETROZOLE, LETROZOLE
OXALI PLATI N, OXALI PLATI N
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
PACLI TAXEL, PACLI TAXEL
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
VI NORELBI NE TARTRATE, VI NORELBI NE TARTRATE
ACTELI ON PHARMS LTD
* ACTELI ON PHARMACEUTI CALS LTD
OPSUMI T, MACI TENTAN
TRACLEER, BOSENTAN
VALCHLOR, MECHLORETHAMI NE HYDROCHLORI DE
VELETRI , EPOPROSTENOL SODI UM
VENTAVI S, I LOPROST
ZAVESCA, MI GLUSTAT
ACTI ENT PHARMS
* ACTI ENT PHARMACEUTI CALS LLC
DI LATRATE- SR, I SOSORBI DE DI NI TRATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 5
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* ACTI ENT PHARMACEUTI CALS LLC
EDEX, ALPROSTADI L
LEVATOL, PENBUTOLOL SULFATE
ROBAXI N, METHOCARBAMOL
ROBAXI N- 750, METHOCARBAMOL
SEMPREX- D, ACRI VASTI NE
STRI ANT, TESTOSTERONE
TESTOPEL, TESTOSTERONE
THEO- 24, THEOPHYLLI NE
ACTI VI S TOTOWA LLC
* ACTI VI S TOTOWA LLC
TOPI RAMATE, TOPI RAMATE
ACTON PHARMS
* ACTON PHARMACEUTI CALS I NC
AEROSPAN HFA, FLUNI SOLI DE
AEGERI ON
* AEGERI ON PHARMACEUTI CALS I NC
J UXTAPI D, LOMI TAPI DE MESYLATE
AGI LA SPECLTS
* AGI LA SPECI ALTI ES PRI VATE LTD
DEXAMETHASONE SODI UM PHOSPHATE, DEXAMETHASONE SODI UM PHOSPHATE
DOXYCYCLI NE, DOXYCYCLI NE HYCLATE
FAMOTI DI NE PRESERVATI VE FREE, FAMOTI DI NE
FAMOTI DI NE, FAMOTI DI NE
FLUMAZENI L, FLUMAZENI L
HALOPERI DOL, HALOPERI DOL LACTATE
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
LI DOCAI NE HYDROCHLORI DE PRESERVATI VE FREE, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE, LI DOCAI NE HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
RI FAMPI N, RI FAMPI N
TOBRAMYCI N SULFATE, TOBRAMYCI N SULFATE
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
VECURONI UM BROMI DE, VECURONI UM BROMI DE
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
AGOURON
* AGOURON PHARMACEUTI CALS I NC
VI RACEPT, NELFI NAVI R MESYLATE
AJ ANTA PHARMA
* AJ ANTA PHARMA LTD
LEVETI RACETAM, LEVETI RACETAM
AJ ANTA PHARMA LTD
* AJ ANTA PHARMA LTD
RI SPERI DONE, RI SPERI DONE
AKORN
* AKORN I NC
ADENOSI NE, ADENOSI NE
AK- FLUOR 10%, FLUORESCEI N SODI UM
AK- FLUOR 25%, FLUORESCEI N SODI UM
AKBETA, LEVOBUNOLOL HYDROCHLORI DE
AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORI DE
AKPRO, DI PI VEFRI N HYDROCHLORI DE
AKTEN, LI DOCAI NE HYDROCHLORI DE
AKTOB, TOBRAMYCI N
ALFENTA, ALFENTANI L HYDROCHLORI DE
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
BACI TRACI N ZI NC AND POLYMYXI N B SULFATE, BACI TRACI N ZI NC
BACI TRACI N, BACI TRACI N
BAL, DI MERCAPROL
BALANCED SALT, CALCI UM CHLORI DE
BETAXOLOL HYDROCHLORI DE, BETAXOLOL HYDROCHLORI DE
BRI MONI DI NE TARTRATE, BRI MONI DI NE TARTRATE
CALCI TRI OL, CALCI TRI OL


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 6
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* AKORN I NC
CAPASTAT SULFATE, CAPREOMYCI N SULFATE
CARBOPLATI N, CARBOPLATI N
CROMOLYN SODI UM, CROMOLYN SODI UM
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
ENDOSOL EXTRA, CALCI UM CHLORI DE
ERYTHROMYCI N, ERYTHROMYCI N
GENTAK, GENTAMI CI N SULFATE
GENTAMI CI N SULFATE, GENTAMI CI N SULFATE
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
HYDROMORPHONE HYDROCHLORI DE, HYDROMORPHONE HYDROCHLORI DE
I C- GREEN, I NDOCYANI NE GREEN
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
KETOTI FEN FUMARATE, KETOTI FEN FUMARATE ( OTC)
LATANOPROST, LATANOPROST
LEVOFLOXACI N, LEVOFLOXACI N
LI DOCAI NE HYDROCHLORI DE, LI DOCAI NE HYDROCHLORI DE
LORAZEPAM, LORAZEPAM
NEDOCROMI L SODI UM, NEDOCROMI L SODI UM
NEOMYCI N AND POLYMYXI N B SULFATES AND BACI TRACI N ZI NC, BACI TRACI N ZI NC
NEOMYCI N AND POLYMYXI N B SULFATES, BACI TRACI N ZI NC AND HYDROCORTI SONE, BACI TRACI N ZI NC
OFLOXACI N, OFLOXACI N
ORPHENADRI NE CI TRATE, ORPHENADRI NE CI TRATE
PAREMYD, HYDROXYAMPHETAMI NE HYDROBROMI DE
SUBLI MAZE PRESERVATI VE FREE, FENTANYL CI TRATE
SUFENTA PRESERVATI VE FREE, SUFENTANI L CI TRATE
TERBUTALI NE SULFATE, TERBUTALI NE SULFATE
TI MOLOL MALEATE, TI MOLOL MALEATE
TROPI CACYL, TROPI CAMI DE
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
AKORN I NC
* AKORN I NC
APRACLONI DI NE HYDROCHLORI DE, APRACLONI DI NE HYDROCHLORI DE
CEFTRI AXONE, CEFTRI AXONE SODI UM
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
CLI NDAMYCI N PHOSPHATE I N 5%DEXTROSE I N PLASTI C CONTAI NER, CLI NDAMYCI N PHOSPHATE
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
I NAPSI NE, DROPERI DOL
LABETALOL HYDROCHLORI DE, LABETALOL HYDROCHLORI DE
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
NAPHAZOLI NE HYDROCHLORI DE AND PHENI RAMI NE MALEATE, NAPHAZOLI NE HYDROCHLORI DE ( OTC)
NAPHAZOLI NE HYDROCHLORI DE, NAPHAZOLI NE HYDROCHLORI DE
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
PROPARACAI NE HYDROCHLORI DE, PROPARACAI NE HYDROCHLORI DE
TRI METHOPRI M SULFATE AND POLYMYXI N B SULFATE, POLYMYXI N B SULFATE
AKRI MAX PHARMS
* AKRI MAX PHARMACEUTI CALS LLC
I NDERAL LA, PROPRANOLOL HYDROCHLORI DE
ALARA PHARM
* ALARA PHARMACEUTI CAL CORPORATI ON
LEVO- T, LEVOTHYROXI NE SODI UM **
ALCON
* ALCON I NC
TRI ESENCE, TRI AMCI NOLONE ACETONI DE
* ALCON LABORATORI ES I NC
ALCAI NE, PROPARACAI NE HYDROCHLORI DE
ALOMI DE, LODOXAMI DE TROMETHAMI NE
BETOPTI C S, BETAXOLOL HYDROCHLORI DE
BETOPTI C, BETAXOLOL HYDROCHLORI DE
BSS PLUS, CALCI UM CHLORI DE
BSS, CALCI UM CHLORI DE
CARTEOLOL HYDROCHLORI DE, CARTEOLOL HYDROCHLORI DE



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 7
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* ALCON LABORATORI ES I NC
CETAMI DE, SULFACETAMI DE SODI UM
CROMOLYN SODI UM, CROMOLYN SODI UM
CYCLOGYL, CYCLOPENTOLATE HYDROCHLORI DE
CYCLOMYDRI L, CYCLOPENTOLATE HYDROCHLORI DE
DENDRI D, I DOXURI DI NE
EMADI NE, EMEDASTI NE DI FUMARATE
FLAREX, FLUOROMETHOLONE ACETATE
I OPI DI NE, APRACLONI DI NE HYDROCHLORI DE
MAXI DEX, DEXAMETHASONE
MAXI TROL, DEXAMETHASONE
MI OSTAT, CARBACHOL
MYDRI ACYL, TROPI CAMI DE
NAPHCON- A, NAPHAZOLI NE HYDROCHLORI DE ( OTC)
NATACYN, NATAMYCI N
OMNI PRED, PREDNI SOLONE ACETATE
PATANOL, OLOPATADI NE HYDROCHLORI DE
PI LOPI NE HS, PI LOCARPI NE HYDROCHLORI DE
TOBRADEX, DEXAMETHASONE
TOBREX, TOBRAMYCI N
VEXOL, RI MEXOLONE
ALCON LABS I NC
* ALCON LABORATORI ES I NC
CYCLOGYL, CYCLOPENTOLATE HYDROCHLORI DE
ALCON PHARMA
* ALCON RESEARCH LTD
AZELASTI NE HYDROCHLORI DE, AZELASTI NE HYDROCHLORI DE
ZADI TOR, KETOTI FEN FUMARATE ( OTC)
ALCON PHARMS LTD
* ALCON PHARMACEUTI CALS LTD
AZOPT, BRI NZOLAMI DE
BETADI NE, POVI DONE- I ODI NE
BRI MONI DI NE TARTRATE, BRI MONI DI NE TARTRATE
CI LOXAN, CI PROFLOXACI N HYDROCHLORI DE
CI PRO HC, CI PROFLOXACI N HYDROCHLORI DE
CI PRODEX, CI PROFLOXACI N
DEXAMETHASONE SODI UM PHOSPHATE, DEXAMETHASONE SODI UM PHOSPHATE
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
DORZOLAMI DE HYDROCHLORI DE, DORZOLAMI DE HYDROCHLORI DE
DUREZOL, DI FLUPREDNATE
FLUORESCI TE, FLUORESCEI N SODI UM
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
KETOTI FEN FUMARATE, KETOTI FEN FUMARATE ( OTC)
MOXEZA, MOXI FLOXACI N HYDROCHLORI DE
NAVSTEL, CALCI UM CHLORI DE
NEOMYCI N AND POLYMYXI N B SULFATES AND HYDROCORTI SONE, HYDROCORTI SONE
NEVANAC, NEPAFENAC
OFLOXACI N, OFLOXACI N
PATADAY, OLOPATADI NE HYDROCHLORI DE
PATANASE, OLOPATADI NE HYDROCHLORI DE
QOLI ANA, BRI MONI DI NE TARTRATE
SULFACETAMI DE SODI UM AND PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
SULFACETAMI DE SODI UM, SULFACETAMI DE SODI UM
TOBRADEX ST, DEXAMETHASONE
TRAVATAN Z, TRAVOPROST
TRI FLURI DI NE, TRI FLURI DI NE
VI GAMOX, MOXI FLOXACI N HYDROCHLORI DE
ALCON RES
* ALCON RESEARCH LTD
DORZOLAMI DE HYDROCHLORI DE AND TI MOLOL MALEATE, DORZOLAMI DE HYDROCHLORI DE
I SOPTO CARPI NE, PI LOCARPI NE HYDROCHLORI DE
LATANOPROST, LATANOPROST
ALCON RES LTD
* ALCON RESEARCH LTD
I LEVRO, NEPAFENAC

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 8
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* ALCON RESEARCH LTD
SI MBRI NZA, BRI MONI DI NE TARTRATE
ALEMBI C LTD
* ALEMBI C LTD
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LI THI UM CARBONATE, LI THI UM CARBONATE
METRONI DAZOLE, METRONI DAZOLE
MODAFI NI L, MODAFI NI L
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
THEOPHYLLI NE, THEOPHYLLI NE
VALSARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
ALEMBI C PHARMS LTD
* ALEMBI C PHARMACEUTI CALS LTD
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
DESVENLAFAXI NE, DESVENLAFAXI NE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
FAMOTI DI NE, FAMOTI DI NE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I RBESARTAN, I RBESARTAN
LAMOTRI GI NE, LAMOTRI GI NE
LEFLUNOMI DE, LEFLUNOMI DE
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
MEPROBAMATE, MEPROBAMATE
METOPROLOL TARTRATE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONI DAZOLE, METRONI DAZOLE
RI VASTI GMI NE TARTRATE, RI VASTI GMI NE TARTRATE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
ALKEM
* ALKEM LABORATORI ES LTD
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
GABAPENTI N, GABAPENTI N
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
ALKEM LABS LTD
* ALKEM LABORATORI ES LTD
CEFUROXI ME AXETI L, CEFUROXI ME AXETI L
CEPHALEXI N, CEPHALEXI N
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
LAMOTRI GI NE, LAMOTRI GI NE
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
QUETI API NE FUMARATE, QUETI API NE FUMARATE
ALKERMES
* ALKERMES I NC
VI VI TROL, NALTREXONE
ALKERMES GAI NESVI LLE
* ALKERMES GAI NESVI LLE LLC
VERELAN PM, VERAPAMI L HYDROCHLORI DE
VERELAN, VERAPAMI L HYDROCHLORI DE
ALKOPHARMA USA
* ALKOPHARMA USA I NC
AMPHOTEC, AMPHOTERI CI N B
ALLEGI ANCE HLTHCARE
* ALLEGI ANCE HEALTHCARE CORP
POVI DONE I ODI NE, POVI DONE- I ODI NE ( OTC)
ALLERGAN
* ALLERGAN
ACULAR LS, KETOROLAC TROMETHAMI NE
ALPHAGAN P, BRI MONI DI NE TARTRATE
BLEPH- 10, SULFACETAMI DE SODI UM
GENOPTI C, GENTAMI CI N SULFATE
ZYMAXI D, GATI FLOXACI N
* ALLERGAN I NC

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 9
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* ALLERGAN I NC
ACULAR, KETOROLAC TROMETHAMI NE
ACUVAI L, KETOROLAC TROMETHAMI NE
ACZONE, DAPSONE
ALBALON, NAPHAZOLI NE HYDROCHLORI DE
ALOCRI L, NEDOCROMI L SODI UM
ALPHAGAN P, BRI MONI DI NE TARTRATE
AVAGE, TAZAROTENE
AZELEX, AZELAI C ACI D
COMBI GAN, BRI MONI DI NE TARTRATE
ELESTAT, EPI NASTI NE HYDROCHLORI DE
LASTACAFT, ALCAFTADI NE
LATI SSE, BI MATOPROST
LUMI GAN, BI MATOPROST
OCUFLOX, OFLOXACI N
OPTI CROM, CROMOLYN SODI UM
OZURDEX, DEXAMETHASONE
POLYTRI M, POLYMYXI N B SULFATE
RESTASI S, CYCLOSPORI NE
SANCTURA XR, TROSPI UM CHLORI DE
SANCTURA, TROSPI UM CHLORI DE
TAZORAC, TAZAROTENE
ZYMAR, GATI FLOXACI N
* ALLERGAN PHARMACEUTI CAL
BETAGAN, LEVOBUNOLOL HYDROCHLORI DE
BLEPHAMI DE S. O. P. , PREDNI SOLONE ACETATE
BLEPHAMI DE, PREDNI SOLONE ACETATE
FML FORTE, FLUOROMETHOLONE
FML, FLUOROMETHOLONE
HERPLEX, I DOXURI DI NE
OCUFEN, FLURBI PROFEN SODI UM
OPHTHETI C, PROPARACAI NE HYDROCHLORI DE
PRED FORTE, PREDNI SOLONE ACETATE
PRED MI LD, PREDNI SOLONE ACETATE
PRED- G, GENTAMI CI N SULFATE
PROPI NE, DI PI VEFRI N HYDROCHLORI DE
ALLERQUEST
* ALLERQUEST LLC
PRE- PEN, BENZYLPENI CI LLOYL POLYLYSI NE
ALLI ED PHARMA I NC
* ALLI ED PHARMA I NC
CLARI THROMYCI N, CLARI THROMYCI N
GABAPENTI N, GABAPENTI N
ALLOS
* ALLOS THERAPEUTI CS I NC
FOLOTYN, PRALATREXATE
ALMATI CA PHARMA I NC
* ALMATI CA PHARMA I NC
NAPRELAN, NAPROXEN SODI UM
ALPHARMA
* ALPHARMA USPD I NC
PREDNI SOLONE, PREDNI SOLONE
VALPROI C ACI D, VALPROI C ACI D
ALPHARMA KI NG
* ALPHARMA PHARMACEUTI CALS LLC KI NG PHARMACEUTI CALS
EMBEDA, MORPHI NE SULFATE
ALRA
* ALRA LABORATORI ES I NC
CHOLAC, LACTULOSE
CONSTI LAC, LACTULOSE
GEN- XENE, CLORAZEPATE DI POTASSI UM
I BU- TAB 200, I BUPROFEN ( OTC)
I BU- TAB, I BUPROFEN
ALTAI RE PHARMS I NC
* ALTAI RE PHARMACEUTI CALS I NC




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 10
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* ALTAI RE PHARMACEUTI CALS I NC
NAPHAZOLI NE HYDROCHLORI DE AND PHENI RAMI NE MALEATE, NAPHAZOLI NE HYDROCHLORI DE ( OTC)
OFLOXACI N, OFLOXACI N
ALTERNA TCHP LLC
* ALTERNA TCHP LLC
CHI LDREN' S ELI XSURE, I BUPROFEN ( OTC)
ALVOGEN
* ALVOGEN I NC
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
TRAZODONE HYDROCHLORI DE, TRAZODONE HYDROCHLORI DE
ALVOGEN I NC
* ALVOGEN I NC
DOXORUBI CI N HYDROCHLORI DE, DOXORUBI CI N HYDROCHLORI DE
MACROBI D, NI TROFURANTOI N
MACRODANTI N, NI TROFURANTOI N, MACROCRYSTALLI NE
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
TRAMADOL HYDROCHLORI DE AND ACETAMI NOPHEN, ACETAMI NOPHEN
ALVOGEN PI NE BROOK
* ALVOGEN PI NE BROOK I NC
DI SULFI RAM , DI SULFI RAM
AM ANTI BI OTI CS
* AMERI CAN ANTI BI OTI CS I NC
AMOXI CI LLI N, AMOXI CI LLI N
AMAG PHARMS I NC
* AMAG PHARMACEUTI CALS I NC
FERAHEME, FERUMOXYTOL
AMARI N PHARMS
* AMARI N PHARMACEUTI CALS I RELAND LTD
VASCEPA, I COSAPENT ETHYL
AMDERMA PHARMS
* AMDERMA PHARMACEUTI CALS LLC
ECOZA, ECONAZOLE NI TRATE
AMEDRA PHARMS
* AMEDRA PHARMACEUTI CALS LLC
ADRENACLI CK, EPI NEPHRI NE
ALBENZA, ALBENDAZOLE
DARAPRI M, PYRI METHAMI NE
DEXEDRI NE, DEXTROAMPHETAMI NE SULFATE
HYDROCORTI SONE, HYDROCORTI SONE
TWI NJ ECT 0. 15, EPI NEPHRI NE
TWI NJ ECT 0. 3, EPI NEPHRI NE
AMGEN
* AMGEN I NC
SENSI PAR, CI NACALCET HYDROCHLORI DE
AMNEAL PHARM
* AMNEAL PHARMACEUTI CAL
ACEBUTOLOL HYDROCHLORI DE, ACEBUTOLOL HYDROCHLORI DE
BETHANECHOL CHLORI DE, BETHANECHOL CHLORI DE
DEMECLOCYCLI NE HYDROCHLORI DE, DEMECLOCYCLI NE HYDROCHLORI DE
FLECAI NI DE ACETATE, FLECAI NI DE ACETATE
FOLI C ACI D, FOLI C ACI D
GUANFACI NE HYDROCHLORI DE, GUANFACI NE HYDROCHLORI DE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
PRI MI DONE, PRI MI DONE
AMNEAL PHARMS
* AMNEAL PHARMACEUTI CALS
ALBUTEROL SULFATE, ALBUTEROL SULFATE
BUPRENORPHI NE HYDROCHLORI DE AND NALOXONE HYDROCHLORI DE , BUPRENORPHI NE HYDROCHLORI DE
BUPRENORPHI NE HYDROCHLORI DE AND NALOXONE HYDROCHLORI DE, BUPRENORPHI NE HYDROCHLORI DE
CETI RI ZI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 11
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* AMNEAL PHARMACEUTI CALS
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
FELBAMATE, FELBAMATE
FOSPHENYTOI N SODI UM, FOSPHENYTOI N SODI UM
GABAPENTI N, GABAPENTI N
I BUPROFEN, I BUPROFEN ( OTC)
I NDOMETHACI N, I NDOMETHACI N
LEVETI RACETAM, LEVETI RACETAM
LORAZEPAM, LORAZEPAM
MECLI ZI NE HYDROCHLORI DE, MECLI ZI NE HYDROCHLORI DE
METAXALONE, METAXALONE
NI TROFURANTOI N, NI TROFURANTOI N
NI ZATI DI NE, NI ZATI DI NE
NORETHI NDRONE ACETATE, NORETHI NDRONE ACETATE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
OXCARBAZEPI NE, OXCARBAZEPI NE
POTASSI UM CHLORI DE, POTASSI UM CHLORI DE
PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
PROMETHAZI NE HYDROCHLORI DE AND CODEI NE PHOSPHATE, CODEI NE PHOSPHATE
PROMETHAZI NE HYDROCHLORI DE AND DEXTROMETHORPHAN HYDROBROMI DE, DEXTROMETHORPHAN
PROMETHAZI NE HYDROCHLORI DE AND PHENYLEPHRI NE HYDROCHLORI DE, PHENYLEPHRI NE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RI SPERI DONE, RI SPERI DONE
SI LDENAFI L CI TRATE, SI LDENAFI L CI TRATE
SPI RONOLACTONE, SPI RONOLACTONE
TRAMADOL HYDROCHLORI DE AND ACETAMI NOPHEN, ACETAMI NOPHEN
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
WARFARI N SODI UM, WARFARI N SODI UM
* AMNEAL PHARMACEUTI CALS LLC
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
* AMNEAL PHARMACEUTI CALS OF NEWYORK LLC
NORETHI NDRONE ACETATE AND ETHI NYL ESTRADI OL AND FERROUS FUMARATE, ETHI NYL ESTRADI OL
NORETHI NDRONE AND ETHI NYL ESTRADI OL AND FERROUS FUMARATE, ETHI NYL ESTRADI OL
AMNEAL PHARMS NY
* AMNEAL PHARMACEUTI CALS NY LLC
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
ALPRAZOLAM, ALPRAZOLAM
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
EXTENDED PHENYTOI N SODI UM, PHENYTOI N SODI UM
GABAPENTI N, GABAPENTI N
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
HYDROCODONE BI TARTRATE AND I BUPROFEN, HYDROCODONE BI TARTRATE
I BUPROFEN, I BUPROFEN
I BUPROFEN, I BUPROFEN ( OTC)
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
NAPROXEN SODI UM, NAPROXEN SODI UM
NAPROXEN SODI UM, NAPROXEN SODI UM ( OTC)
NAPROXEN, NAPROXEN
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
REPREXAI N, HYDROCODONE BI TARTRATE
SULFAMETHOXAZOLE AND TRI METHOPRI M, SULFAMETHOXAZOLE
AMPHASTAR PHARM
* AMPHASTAR PHARMACEUTI CAL I NC
AMPHADASE, HYALURONI DASE
ENOXAPARI N SODI UM ( PRESERVATI VE FREE) , ENOXAPARI N SODI UM
AMPHASTAR PHARMS I NC
* AMPHASTAR PHARMACEUTI CALS I NC
CORTROSYN, COSYNTROPI N
AMPOLGEN

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 12
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* AMPOLGEN PHARMACEUTI CALS LLC
SODI UM PHENYLBUTYRATE, SODI UM PHENYLBUTYRATE
AMYLI N
* AMYLI N PHARMACEUTI CALS I NC
BYDUREON, EXENATI DE SYNTHETI C
BYETTA, EXENATI DE SYNTHETI C
AMYLI N PHARMS LLC
* AMYLI N PHARMACEUTI CALS LLC
SYMLI N, PRAMLI NTI DE ACETATE
ANBEX
* ANBEX I NC
I OSAT, POTASSI UM I ODI DE ( OTC)
ANCHEN PHARMS
* ANCHEN PHARMACEUTI CALS I NC
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
CLONI DI NE HYDROCHLORI DE , CLONI DI NE HYDROCHLORI DE
FENOFI BRI C ACI D, CHOLI NE FENOFI BRATE
FLUVOXAMI NE MALEATE, FLUVOXAMI NE MALEATE
LAMOTRI GI NE, LAMOTRI GI NE
LEVETI RACETAM, LEVETI RACETAM
POTASSI UM CHLORI DE, POTASSI UM CHLORI DE
TAMSULOSI N HYDROCHLORI DE, TAMSULOSI N HYDROCHLORI DE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
TRETI NOI N, TRETI NOI N
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
* ANCHEN PHARMACEUTI CALS TAI WAN I NC
DI VALPROEX SODI UM, DI VALPROEX SODI UM
* ANCHEN PHARMACEUTI CALS, I NC
ALPRAZOLAM, ALPRAZOLAM
CI PROFLOXACI N EXTENDED RELEASE, CI PROFLOXACI N
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
ANDRX LABS LLC
* ANDRX LABS LLC
ALTOPREV, LOVASTATI N
FORTAMET, METFORMI N HYDROCHLORI DE
ANGELI NI PHARMA
* ANGELI NI PHARMA I NC
OLEPTRO, TRAZODONE HYDROCHLORI DE
ANI PHARMS
* ANI PHARMACEUTI CALS I NC
CORTENEMA, HYDROCORTI SONE
LACTULOSE, LACTULOSE
LUVOX, FLUVOXAMI NE MALEATE
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
REGLAN, METOCLOPRAMI DE HYDROCHLORI DE
ANTARES PHARMA I NC
* ANTARES PHARMA I NC
OTREXUP, METHOTREXATE
ANTI BI OTI CE
* ANTI BI OTI CE SA
NAFCI LLI N SODI UM, NAFCI LLI N SODI UM
ANTI BI OTI COS BRASI L
* ANTI BI OTI COS DO BRASI L LTDA
CEFOXI TI N, CEFOXI TI N SODI UM
APGDI
* ASTELLAS PHARMA GLOBAL DEVELOPMENT I NC
MYRBETRI Q, MI RABEGRON
APOPHARMA I NC
* APOPHARMA I NC
FERRI PROX, DEFERI PRONE
APOTEX
* APOTEX CORP
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 13
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* APOTEX CORP
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
* APOTEX I NC
ALENDRONATE SODI UM, ALENDRONATE SODI UM
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
CAPTOPRI L, CAPTOPRI L
CARBI DOPA AND LEVODOPA, CARBI DOPA
CEFUROXI ME AXETI L, CEFUROXI ME AXETI L
CI METI DI NE, CI METI DI NE
CI METI DI NE, CI METI DI NE ( OTC)
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
CYCLOSPORI NE, CYCLOSPORI NE
DI CLOFENAC POTASSI UM, DI CLOFENAC POTASSI UM
DI LT- CD, DI LTI AZEM HYDROCHLORI DE
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DOXAZOSI N MESYLATE, DOXAZOSI N MESYLATE
ENALAPRI L MALEATE, ENALAPRI L MALEATE
EPI NASTI NE HYDROCHLORI DE, EPI NASTI NE HYDROCHLORI DE
EPLERENONE, EPLERENONE
ETODOLAC, ETODOLAC
FAMCI CLOVI R, FAMCI CLOVI R
FAMOTI DI NE, FAMOTI DI NE
FLUCONAZOLE, FLUCONAZOLE
FLUVOXAMI NE MALEATE, FLUVOXAMI NE MALEATE
GEMFI BROZI L, GEMFI BROZI L
GLI PI ZI DE, GLI PI ZI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
KETOCONAZOLE, KETOCONAZOLE
LAMI VUDI NE, LAMI VUDI NE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
PAROXETI NE HYDROCHLORI DE, PAROXETI NE HYDROCHLORI DE
PENTOXI FYLLI NE, PENTOXI FYLLI NE
PERI NDOPRI L ERBUMI NE, PERI NDOPRI L ERBUMI NE
RAMI PRI L, RAMI PRI L
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
SELEGI LI NE HYDROCHLORI DE, SELEGI LI NE HYDROCHLORI DE
SOTALOL HYDROCHLORI DE, SOTALOL HYDROCHLORI DE
TAMOXI FEN CI TRATE, TAMOXI FEN CI TRATE
TERAZOSI N HYDROCHLORI DE, TERAZOSI N HYDROCHLORI DE
TI CLOPI DI NE HYDROCHLORI DE, TI CLOPI DI NE HYDROCHLORI DE
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
TRAZODONE HYDROCHLORI DE, TRAZODONE HYDROCHLORI DE
TROSPI UM CHLORI DE, TROSPI UM CHLORI DE
APOTEX CORP
* APOTEX CORP
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
AZI THROMYCI N, AZI THROMYCI N
CABERGOLI NE, CABERGOLI NE
CLARI THROMYCI N, CLARI THROMYCI N
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
MONTELUKAST SODI UM, MONTELUKAST SODI UM
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
NARATRI PTAN, NARATRI PTAN
QUI NAPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
RI LUZOLE, RI LUZOLE
SI LDENAFI L CI TRATE, SI LDENAFI L CI TRATE
TOLTERODI NE TARTRATE, TOLTERODI NE TARTRATE
VERAPAMI L HYDROCHLORI DE, VERAPAMI L HYDROCHLORI DE
ZI PRASI DONE HYDROCHLORI DE, ZI PRASI DONE HYDROCHLORI DE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 14
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
APOTEX I NC
* APOTEX I NC
ABACAVI R SULFATE, ABACAVI R SULFATE
ALFUZOSI N HYDROCHLORI DE, ALFUZOSI N HYDROCHLORI DE
ALPRAZOLAM, ALPRAZOLAM
AMLODI PI NE BESYLATE AND BENAZEPRI L HYDROCHLORI DE, AMLODI PI NE BESYLATE
ANASTROZOLE, ANASTROZOLE
ATORVASTATI N CALCI UM, ATORVASTATI N CALCI UM
AZELASTI NE HYDROCHLORI DE, AZELASTI NE HYDROCHLORI DE
CALCI TONI N- SALMON, CALCI TONI N SALMON
CANDESARTAN CI LEXETI L AND HYDROCHLOROTHI AZI DE, CANDESARTAN CI LEXETI L
CANDESARTAN CI LEXETI L, CANDESARTAN CI LEXETI L
CARBAMAZEPI NE, CARBAMAZEPI NE
CARBI DOPA AND LEVODOPA, CARBI DOPA
CEFPROZI L, CEFPROZI L
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CEVI MELI NE, CEVI MELI NE HYDROCHLORI DE
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
FENOFI BRATE ( MI CRONI ZED) , FENOFI BRATE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
I BANDRONATE SODI UM, I BANDRONATE SODI UM
I MI QUI MOD, I MI QUI MOD
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I RBESARTAN, I RBESARTAN
LAMI VUDI NE, LAMI VUDI NE
LAMOTRI GI NE, LAMOTRI GI NE
LETROZOLE, LETROZOLE
LEVETI RACETAM, LEVETI RACETAM
LEVOFLOXACI N, LEVOFLOXACI N
LOVASTATI N, LOVASTATI N
MI LRI NONE LACTATE I N DEXTROSE 5%, MI LRI NONE LACTATE
MOEXI PRI L HYDROCHLORI DE, MOEXI PRI L HYDROCHLORI DE
MONTELUKAST SODI UM, MONTELUKAST SODI UM
MYCOPHENOLI C ACI D, MYCOPHENOLI C ACI D
NABUMETONE, NABUMETONE
NEVI RAPI NE, NEVI RAPI NE
OFLOXACI N, OFLOXACI N
OLANZAPI NE, OLANZAPI NE
OXCARBAZEPI NE, OXCARBAZEPI NE
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
RASAGI LI NE MESYLATE, RASAGI LI NE MESYLATE
RI SPERI DONE, RI SPERI DONE
RI VASTI GMI NE TARTRATE, RI VASTI GMI NE TARTRATE
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
TRAZODONE HYDROCHLORI DE, TRAZODONE HYDROCHLORI DE
TRI AMTERENE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
VALSARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
ZOLMI TRI PTAN, ZOLMI TRI PTAN
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
* APOTEX I NC ETOBI COKE SI TE
ACYCLOVI R, ACYCLOVI R
ALLOPURI NOL, ALLOPURI NOL
BALSALAZI DE DI SODI UM, BALSALAZI DE DI SODI UM
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
CARBAMAZEPI NE, CARBAMAZEPI NE
CARVEDI LOL, CARVEDI LOL
CI LOSTAZOL, CI LOSTAZOL

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 15
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* APOTEX I NC ETOBI COKE SI TE
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
DESMOPRESSI N ACETATE, DESMOPRESSI N ACETATE
DI LTZAC, DI LTI AZEM HYDROCHLORI DE
ENALAPRI L MALEATE AND HYDROCHLOROTHI AZI DE, ENALAPRI L MALEATE
ETODOLAC, ETODOLAC
FOSI NOPRI L SODI UM, FOSI NOPRI L SODI UM
GABAPENTI N, GABAPENTI N
LEFLUNOMI DE, LEFLUNOMI DE
LI SI NOPRI L AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LI SI NOPRI L, LI SI NOPRI L
LORATADI NE, LORATADI NE ( OTC)
MELOXI CAM, MELOXI CAM
MI DODRI NE HYDROCHLORI DE, MI DODRI NE HYDROCHLORI DE
MI RTAZAPI NE, MI RTAZAPI NE
OXAPROZI N, OXAPROZI N
SELEGI LI NE HYDROCHLORI DE, SELEGI LI NE HYDROCHLORI DE
SOTALOL HYDROCHLORI DE, SOTALOL HYDROCHLORI DE
TOPI RAMATE, TOPI RAMATE
TORSEMI DE, TORSEMI DE
ZONI SAMI DE, ZONI SAMI DE
* APOTEX I NC RI CHMOND HI LL
AZELASTI NE HYDROCHLORI DE, AZELASTI NE HYDROCHLORI DE
DESMOPRESSI N ACETATE ( NEEDS NO REFRI GERATI ON) , DESMOPRESSI N ACETATE
FLUNI SOLI DE, FLUNI SOLI DE
FLUTI CASONE PROPI ONATE, FLUTI CASONE PROPI ONATE
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
RI SPERI DONE, RI SPERI DONE
* APOTEX I NC.
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
APOTHECON
* APOTHECON I NC DI V BRI STOL MYERS SQUI BB
CAPOZI DE 25/ 15, CAPTOPRI L
CAPOZI DE 25/ 25, CAPTOPRI L
CAPOZI DE 50/ 15, CAPTOPRI L
CAPOZI DE 50/ 25, CAPTOPRI L
KENALOG- 10, TRI AMCI NOLONE ACETONI DE
KENALOG- 40, TRI AMCI NOLONE ACETONI DE
OPHTHAI NE, PROPARACAI NE HYDROCHLORI DE
APP PHARMS
* APP PHARMACEUTI CALS LLC
DI PHENHYDRAMI NE HYDROCHLORI DE, DI PHENHYDRAMI NE HYDROCHLORI DE
APTALI S PHARMA
* APTALI S PHARMA LTD
RECTI V, NI TROGLYCERI N
APTALI S PHARMA US
* APTALI S PHARMA US I NC
BENTYL PRESERVATI VE FREE, DI CYCLOMI NE HYDROCHLORI DE
BENTYL, DI CYCLOMI NE HYDROCHLORI DE
CANASA, MESALAMI NE
CARAFATE, SUCRALFATE
PYLERA, BI SMUTH SUBCI TRATE POTASSI UM
ULTRESA, PANCRELI PASE ( AMYLASE
URSO 250, URSODI OL
URSO FORTE, URSODI OL
VI OKACE, PANCRELI PASE ( AMYLASE
ZENPEP, PANCRELI PASE ( AMYLASE
APTALI S PHARMATECH
* APTALI S PHARMATECH I NC
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
AQUA PHARMS
* AQUA PHARMACEUTI CALS
CORDRAN SP, FLURANDRENOLI DE
CORDRAN, FLURANDRENOLI DE
MONODOX, DOXYCYCLI NE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 16
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* AQUA PHARMACEUTI CALS LLC
FLUOROPLEX, FLUOROURACI L
XOLEGEL, KETOCONAZOLE
ARBOR PHARMS I NC
* ARBOR PHARMACEUTI CALS I NC
AMPHETAMI NE SULFATE, AMPHETAMI NE SULFATE
BI DI L, HYDRALAZI NE HYDROCHLORI DE
E. E. S. 200, ERYTHROMYCI N ETHYLSUCCI NATE
E. E. S. 400, ERYTHROMYCI N ETHYLSUCCI NATE
E. E. S. , ERYTHROMYCI N ETHYLSUCCI NATE
ERY- TAB, ERYTHROMYCI N
ERYPED, ERYTHROMYCI N ETHYLSUCCI NATE
ERYTHROCI N STEARATE, ERYTHROMYCI N STEARATE
ERYTHROMYCI N ETHYLSUCCI NATE, ERYTHROMYCI N ETHYLSUCCI NATE
ERYTHROMYCI N, ERYTHROMYCI N
NYMALI ZE, NI MODI PI NE
PCE, ERYTHROMYCI N
PEDI AMYCI N 400, ERYTHROMYCI N ETHYLSUCCI NATE
PEDI AMYCI N, ERYTHROMYCI N ETHYLSUCCI NATE
ARBOR PHARMS LLC
* ARBOR PHARMACEUTI CALS LLC
EDARBI , AZI LSARTAN KAMEDOXOMI L
EDARBYCLOR, AZI LSARTAN KAMEDOXOMI L
GLI ADEL, CARMUSTI NE
ARCO PHARMS LLC
* ARCO PHARMACEUTI CALS LLC
THYROSHI ELD, POTASSI UM I ODI DE ( OTC)
AREVA PHARMS
* AREVA PHARMACEUTI CALS I NC
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
ARI AD
* ARI AD PHARMACEUTI CALS I NC
I CLUSI G, PONATI NI B HYDROCHLORI DE
ASCEND
* ASCEND THERAPEUTI CS I NC
ESTROGEL, ESTRADI OL
ASPEN GLOBAL
* ASPEN GLOBAL I NC
MYLERAN, BUSULFAN
ASPEN GLOBAL I NC
* ASPEN GLOBAL I NC
LEUKERAN, CHLORAMBUCI L
THI OGUANI NE, THI OGUANI NE
ASTELLAS
* ASTELLAS PHARMA US I NC
ADENOCARD, ADENOSI NE
ADENOSCAN, ADENOSI NE
AMBI SOME, AMPHOTERI CI N B
ASTAGRAF XL, TACROLI MUS
LEXI SCAN, REGADENOSON
MYCAMI NE, MI CAFUNGI N SODI UM
PROGRAF, TACROLI MUS
PROTOPI C, TACROLI MUS
VAPRI SOL I N 5%DEXTROSE I N PLASTI C CONTAI NER, CONI VAPTAN HYDROCHLORI DE
VESI CARE, SOLI FENACI N SUCCI NATE
XTANDI , ENZALUTAMI DE
ASTRAZENECA
* ASTRAZENECA LP
DUTOPROL, HYDROCHLOROTHI AZI DE
ENTOCORT EC, BUDESONI DE
NEXI UM I V, ESOMEPRAZOLE SODI UM
NEXI UM, ESOMEPRAZOLE MAGNESI UM
PRI LOSEC OTC, OMEPRAZOLE MAGNESI UM ( OTC)
PRI LOSEC, OMEPRAZOLE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 17
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* ASTRAZENECA LP
PRI LOSEC, OMEPRAZOLE MAGNESI UM
PULMI CORT FLEXHALER, BUDESONI DE
PULMI CORT RESPULES, BUDESONI DE
RHI NOCORT, BUDESONI DE
SEROQUEL, QUETI API NE FUMARATE
SYMBI CORT, BUDESONI DE
TENORMI N, ATENOLOL
TOPROL- XL, METOPROLOL SUCCI NATE
* ASTRAZENECA PHARMACEUTI CALS LP
ATACAND HCT, CANDESARTAN CI LEXETI L
ATACAND, CANDESARTAN CI LEXETI L
FASLODEX, FULVESTRANT
PLENDI L, FELODI PI NE
SEROQUEL XR, QUETI API NE FUMARATE
TENORETI C 100, ATENOLOL
TENORETI C 50, ATENOLOL
ZOMI G, ZOLMI TRI PTAN
ZOMI G- ZMT, ZOLMI TRI PTAN
* ASTRAZENECA UK LTD
ACCOLATE, ZAFI RLUKAST
ARI MI DEX, ANASTROZOLE
CASODEX, BI CALUTAMI DE
MERREM, MEROPENEM
ZESTORETI C, HYDROCHLOROTHI AZI DE
ZESTRI L, LI SI NOPRI L
ZOLADEX, GOSERELI N ACETATE
ASTRAZENECA LP
* ASTRAZENECA LP
BRI LI NTA, TI CAGRELOR
ATON
* ATON PHARMA I NC
CUPRI MI NE, PENI CI LLAMI NE
EDECRI N, ETHACRYNATE SODI UM
EDECRI N, ETHACRYNI C ACI D
LACRI SERT, HYDROXYPROPYL CELLULOSE
LODOSYN, CARBI DOPA
SYPRI NE, TRI ENTI NE HYDROCHLORI DE
TI MOPTI C I N OCUDOSE, TI MOLOL MALEATE
TI MOPTI C, TI MOLOL MALEATE
ATON PHARMA VPNA
* ATON PHARMA DI V VALEANT PHARMACEUTI CALS NORTH AMERI CA LLC
DEMSER, METYROSI NE
AUROBI NDO
* AUROBI NDO PHARMA LTD
AMOXI CI LLI N, AMOXI CI LLI N
CEFADROXI L, CEFADROXI L/ CEFADROXI L HEMI HYDRATE
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
CLARI THROMYCI N, CLARI THROMYCI N
DI DANOSI NE, DI DANOSI NE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
LI SI NOPRI L AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LI SI NOPRI L, LI SI NOPRI L
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
MI RTAZAPI NE, MI RTAZAPI NE
NEVI RAPI NE, NEVI RAPI NE
ZI DOVUDI NE, ZI DOVUDI NE
AUROBI NDO PHARM
* AUROBI NDO PHARMA USA I NC
FLUCONAZOLE, FLUCONAZOLE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
GABAPENTI N, GABAPENTI N
LEVETI RACETAM, LEVETI RACETAM
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
AUROBI NDO PHARMA


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 18
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* AUROBI NDO PHARMA
AMPI CI LLI N AND SULBACTAM, AMPI CI LLI N SODI UM
* AUROBI NDO PHARMA LTD
ALENDRONATE SODI UM, ALENDRONATE SODI UM
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
AMPI CI LLI N SODI UM, AMPI CI LLI N SODI UM
ATENOLOL, ATENOLOL
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
BI SOPROLOL FUMARATE, BI SOPROLOL FUMARATE
CARI SOPRODOL, CARI SOPRODOL
CARVEDI LOL, CARVEDI LOL
CEFADROXI L, CEFADROXI L/ CEFADROXI L HEMI HYDRATE
CEFDI NI R, CEFDI NI R
CEFPODOXI ME PROXETI L, CEFPODOXI ME PROXETI L
CEFPROZI L, CEFPROZI L
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
CLI NDAMYCI N HYDROCHLORI DE, CLI NDAMYCI N HYDROCHLORI DE
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
DI DANOSI NE, DI DANOSI NE
FI NASTERI DE, FI NASTERI DE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FOSI NOPRI L SODI UM AND HYDROCHLOROTHI AZI DE, FOSI NOPRI L SODI UM
GLYBURI DE AND METFORMI N HYDROCHLORI DE, GLYBURI DE
GLYBURI DE, GLYBURI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LAMOTRI GI NE, LAMOTRI GI NE
LEVETI RACETAM, LEVETI RACETAM
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
MELOXI CAM, MELOXI CAM
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON, ONDANSETRON
PAROXETI NE HYDROCHLORI DE, PAROXETI NE HYDROCHLORI DE
PENI CI LLI N V POTASSI UM, PENI CI LLI N V POTASSI UM
PERI NDOPRI L ERBUMI NE, PERI NDOPRI L ERBUMI NE
QUI NAPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
RI BAVARI N, RI BAVI RI N
RI BAVI RI N, RI BAVI RI N
RI SPERI DONE, RI SPERI DONE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SI MVASTATI N, SI MVASTATI N
STAVUDI NE, STAVUDI NE
SULFAMETHOXAZOLE AND TRI METHOPRI M, SULFAMETHOXAZOLE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
TOPI RAMATE, TOPI RAMATE
TORSEMI DE, TORSEMI DE
TRANDOLAPRI L, TRANDOLAPRI L
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
ZALEPLON, ZALEPLON
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
AUROBI NDO PHARMA LTD
* AUROBI NDO PHARMA LI MI TED
DI VALPROEX SODI UM, DI VALPROEX SODI UM
FOSI NOPRI L SODI UM, FOSI NOPRI L SODI UM
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
LEVOFLOXACI N, LEVOFLOXACI N
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
* AUROBI NDO PHARMA LTD
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 19
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
* AUROBI NDO PHARMA LTD
ABACAVI R SULFATE, ABACAVI R SULFATE
ACYCLOVI R SODI UM, ACYCLOVI R SODI UM
ALFUZOSI N HYDROCHLORI DE, ALFUZOSI N HYDROCHLORI DE
AMLODI PI NE BESYLATE AND BENAZEPRI L HYDROCHLORI DE, AMLODI PI NE BESYLATE
AMOXI CI LLI N AND CLAVULANATE POTASSI UM, AMOXI CI LLI N
BUPI VACAI NE HYDROCHLORI DE PRESERVATI VE FREE, BUPI VACAI NE HYDROCHLORI DE
CEFPODOXI ME PROXETI L, CEFPODOXI ME PROXETI L
CLI NDAMYCI N PALMI TATE HYDROCHLORI DE, CLI NDAMYCI N PALMI TATE HYDROCHLORI DE
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
DULOXETI NE HYDROCHLORI DE, DULOXETI NE HYDROCHLORI DE
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
FAMCI CLOVI R, FAMCI CLOVI R
FELODI PI NE, FELODI PI NE
FI NASTERI DE, FI NASTERI DE
GABAPENTI N, GABAPENTI N
GLI MEPI RI DE, GLI MEPI RI DE
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I RBESARTAN, I RBESARTAN
LAMI VUDI NE AND ZI DOVUDI NE, LAMI VUDI NE
LAMI VUDI NE, LAMI VUDI NE
LEVOFLOXACI N, LEVOFLOXACI N
LI DOCAI NE HYDROCHLORI DE PRESERVATI VE FREE, LI DOCAI NE HYDROCHLORI DE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
MODAFI NI L, MODAFI NI L
MONTELUKAST SODI UM, MONTELUKAST SODI UM
NAFCI LLI N SODI UM, NAFCI LLI N SODI UM
NAPROXEN SODI UM, NAPROXEN SODI UM
OLANZAPI NE, OLANZAPI NE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
OXACI LLI N SODI UM, OXACI LLI N SODI UM
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
PI OGLI TAZONE HYDROCHLORI DE AND METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
PI PERACI LLI N AND TAZOBACTAM, PI PERACI LLI N SODI UM
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
QUI NAPRI L HYDROCHLORI DE, QUI NAPRI L HYDROCHLORI DE
RAMI PRI L, RAMI PRI L
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TAMSULOSI N HYDROCHLORI DE, TAMSULOSI N HYDROCHLORI DE
VALSARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
* AUROBI NDO PHARMA LTD I NC
CEFPROZI L, CEFPROZI L
CEFUROXI ME AXETI L, CEFUROXI ME AXETI L
CEPHALEXI N, CEPHALEXI N
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
MI RTAZAPI NE, MI RTAZAPI NE
ZI DOVUDI NE, ZI DOVUDI NE
AUROBI NDO PHARMA USA
* AUROBI NDO PHARMA USA I NC
ALPRAZOLAM, ALPRAZOLAM
NAPROXEN, NAPROXEN
AUROLI FE PHARMA LLC
* AUROLI FE PHARMA LLC
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMI NE
DEXTROAMPHETAMI NE SULFATE, DEXTROAMPHETAMI NE SULFATE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 20
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * A * *
AUSTARPHARMA LLC
* AUSTARPHARMA LLC
ALENDRONATE SODI UM, ALENDRONATE SODI UM
METHOCARBAMOL, METHOCARBAMOL
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
AUXI LI UM PHARMS
* AUXI LI UM PHARMACEUTI CALS I NC
TESTI M, TESTOSTERONE
AVACOR PRODS
* AVACOR PRODUCTS LLC
MI NOXI DI L EXTRA STRENGTH ( FOR MEN) , MI NOXI DI L ( OTC)
AVANI R PHARMS
* AVANI R PHARMACEUTI CALS I NC
NUEDEXTA, DEXTROMETHORPHAN HYDROBROMI DE
AVANTHI I NC
* AVANTHI I NC
CHLORPHENI RAMI NE MALEATE, CHLORPHENI RAMI NE MALEATE ( OTC)
DEXBROMPHENI RAMI NE MALEATE AND PSEUDOEPHEDRI NE SULFATE, DEXBROMPHENI RAMI NE MALEATE
DI ETHYLPROPI ON HYDROCHLORI DE, DI ETHYLPROPI ON HYDROCHLORI DE
I NDOMETHACI N, I NDOMETHACI N
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
OXYMORPHONE HYDROCHLORI DE, OXYMORPHONE HYDROCHLORI DE
AVEMA PHARMA
* AVEMA PHARMA SOLUTI ONS
I BUPROFEN, I BUPROFEN ( OTC)
AVENT
* AVENT I NC
PYTEST KI T, UREA, C- 14
PYTEST, UREA, C- 14
AVEVA
* AVEVA DRUG DELI VERY SYSTEMS I NC
CLONI DI NE, CLONI DI NE
FENTANYL- 100, FENTANYL
FENTANYL- 25, FENTANYL
FENTANYL- 50, FENTANYL
FENTANYL- 75, FENTANYL
NI COTI NE, NI COTI NE ( OTC)
AVI D RADI OPHARMS I NC
* AVI D RADI OPHARMACEUTI CALS I NC
AMYVI D, FLORBETAPI R F- 18
AZTI Q PHARMA
* AZTI Q PHARMA I NC
TODAY, NONOXYNOL- 9 ( OTC)
* * B * *
B BRAUN
* B BRAUN MEDI CAL I NC
ACETI C ACI D 0. 25%I N PLASTI C CONTAI NER, ACETI C ACI D, GLACI AL
ALCOHOL 10%AND DEXTROSE 5%, ALCOHOL
ALCOHOL 5%AND DEXTROSE 5%, ALCOHOL
AMI NO ACI DS, AMI NO ACI DS
BALANCED SALT, CALCI UM CHLORI DE
BRETYLI UM TOSYLATE I N DEXTROSE 5%I N PLASTI C CONTAI NER, BRETYLI UM TOSYLATE
CEFAZOLI N AND DEXTROSE, CEFAZOLI N SODI UM
CEFEPI ME AND DEXTROSE I N DUPLEX CONTAI NER, CEFEPI ME HYDROCHLORI DE
CEFOTETAN AND DEXTROSE I N DUPLEX CONTAI NER, CEFOTETAN DI SODI UM
CEFOXI TI N AND DEXTROSE I N DUPLEX CONTAI NER, CEFOXI TI N SODI UM
CEFTAZI DI ME I N DEXTROSE CONTAI NER, CEFTAZI DI ME
CEFTRI AXONE AND DEXTROSE I N DUPLEX CONTAI NER, CEFTRI AXONE SODI UM
CEFUROXI ME AND DEXTROSE I N DUPLEX CONTAI NER, CEFUROXI ME SODI UM
DEXTROSE 10%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 10%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, DEXTROSE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 21
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* B BRAUN MEDI CAL I NC
DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 10%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%I N HALF- STRENGTH LACTATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM
DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N ACETATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DEXTROSE 5%I N LACTATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ALYTE CONCENTRATE W/ DEXTROSE 30%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ALYTE CONCENTRATE W/ DEXTROSE 50%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ALYTE LM/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ALYTE LM/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ALYTE LM/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DOPAMI NE HYDROCHLORI DE AND DEXTROSE 5%I N PLASTI C CONTAI NER, DOPAMI NE HYDROCHLORI DE
DOPAMI NE HYDROCHLORI DE AND DEXTROSE 5%, DOPAMI NE HYDROCHLORI DE
FREAMI NE HBC 6. 9%, AMI NO ACI DS
FREAMI NE I I I 10%, AMI NO ACI DS
FREAMI NE I I I 3%W/ ELECTROLYTES, AMI NO ACI DS
FREAMI NE I I I 8. 5%W/ ELECTROLYTES, AMI NO ACI DS
FREAMI NE I I I 8. 5%, AMI NO ACI DS
GENTAMI CI N SULFATE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, GENTAMI CI N SULFATE
GLYCI NE 1. 5%I N PLASTI C CONTAI NER, GLYCI NE
HEPARI N SODI UM 1, 000 UNI TS I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, HEPARI N
HEPARI N SODI UM 20, 000 UNI TS I N DEXTROSE 5%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 25, 000 UNI TS I N DEXTROSE 5%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPATAMI NE 8%, AMI NO ACI DS
I SOLYTE E I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
I SOLYTE H I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
I SOLYTE M I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
I SOLYTE P I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
I SOLYTE R I N DEXTROSE 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
I SOLYTE S I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
I SOLYTE S I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
I SOLYTE S PH 7. 4 I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
LACTATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
LI DOCAI NE HYDROCHLORI DE 0. 2%AND DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE
LI DOCAI NE HYDROCHLORI DE 0. 4%AND DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE
LI DOCAI NE HYDROCHLORI DE 0. 8%AND DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE
MANNI TOL 10%I N PLASTI C CONTAI NER, MANNI TOL
MANNI TOL 10%W/ DEXTROSE 5%I N DI STI LLED WATER, MANNI TOL
MANNI TOL 10%, MANNI TOL
MANNI TOL 15%I N PLASTI C CONTAI NER, MANNI TOL
MANNI TOL 15%W/ DEXTROSE 5%I N SODI UM CHLORI DE 0. 45%, MANNI TOL
MANNI TOL 15%, MANNI TOL
MANNI TOL 20%I N PLASTI C CONTAI NER, MANNI TOL
MANNI TOL 20%, MANNI TOL
MANNI TOL 5%I N PLASTI C CONTAI NER, MANNI TOL
MANNI TOL 5%W/ DEXTROSE 5%I N SODI UM CHLORI DE 0. 12%, MANNI TOL
MANNI TOL 5%, MANNI TOL
METRO I . V. I N PLASTI C CONTAI NER, METRONI DAZOLE
MI LRI NONE LACTATE I N DEXTROSE 5%I N PLASTI C CONTAI NER, MI LRI NONE LACTATE
NEPHRAMI NE 5. 4%, AMI NO ACI DS
NUTRI LI PI D 10%, SOYBEAN OI L
NUTRI LI PI D 20%, SOYBEAN OI L
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 22
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* B BRAUN MEDI CAL I NC
PHYSI OLYTE I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C
POTASSI UM CHLORI DE 0. 037%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 075%I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 11%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 15%I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE 0. 15%I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, POTASSI UM
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 22%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 3. 3%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 11%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 0. 3%I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE, POTASSI UM CHLORI DE
PROCALAMI NE, AMI NO ACI DS
RESECTI SOL I N PLASTI C CONTAI NER, MANNI TOL
RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE








34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 23
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* B BRAUN MEDI CAL I NC
SODI UM LACTATE 1/ 6 MOLAR I N PLASTI C CONTAI NER, SODI UM LACTATE
SORBI TOL 3. 3%I N PLASTI C CONTAI NER, SORBI TOL
STERI LE WATER FOR I NJ ECTI ON I N PLASTI C CONTAI NER, STERI LE WATER FOR I NJ ECTI ON
STERI LE WATER I N PLASTI C CONTAI NER, STERI LE WATER FOR I RRI GATI ON
THEOPHYLLI NE 0. 04%AND DEXTROSE 5%I N PLASTI C CONTAI NER, THEOPHYLLI NE
THEOPHYLLI NE 0. 08%AND DEXTROSE 5%I N PLASTI C CONTAI NER, THEOPHYLLI NE
THEOPHYLLI NE 0. 16%AND DEXTROSE 5%I N PLASTI C CONTAI NER, THEOPHYLLI NE
THEOPHYLLI NE 0. 32%AND DEXTROSE 5%I N PLASTI C CONTAI NER, THEOPHYLLI NE
TROPHAMI NE 10%, AMI NO ACI DS
TROPHAMI NE, AMI NO ACI DS
BAJ AJ MEDI CAL LLC
* BAJ AJ MECI CAL LLC
DYNA- HEX, CHLORHEXI DI NE GLUCONATE ( OTC)
BANNER PHARMACAPS
* BANNER PHARMACAPS I NC
AMANTADI NE HYDROCHLORI DE, AMANTADI NE HYDROCHLORI DE
BENZONATATE, BENZONATATE
CALCI TRI OL, CALCI TRI OL
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
DUTASTERI DE, DUTASTERI DE
ETHOSUXI MI DE, ETHOSUXI MI DE
I BUPROFEN AND DI PHENHYDRAMI NE HYDROCHLORI DE, DI PHENHYDRAMI NE HYDROCHLORI DE ( OTC)
I BUPROFEN, I BUPROFEN ( OTC)
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE ( OTC)
MI DOL LI QUI D GELS, I BUPROFEN ( OTC)
NAPROXEN SODI UM, NAPROXEN SODI UM ( OTC)
NI MODI PI NE, NI MODI PI NE
PROGESTERONE, PROGESTERONE
VALPROI C ACI D, VALPROI C ACI D
VI TAMI N D, ERGOCALCI FEROL
ZONI SAMI DE, ZONI SAMI DE
BARR
* BARR LABORATORI ES I NC
ALPRAZOLAM, ALPRAZOLAM
AMI LORI DE HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, AMI LORI DE HYDROCHLORI DE
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
ANAGRELI DE HYDROCHLORI DE, ANAGRELI DE HYDROCHLORI DE
ARANELLE, ETHI NYL ESTRADI OL
ASPI RI N AND DI PYRI DAMOLE, ASPI RI N
BALZI VA- 28, ETHI NYL ESTRADI OL
BUPRENORPHI NE HYDROCHLORI DE, BUPRENORPHI NE HYDROCHLORI DE
CAMI LA, NORETHI NDRONE
CHLORDI AZEPOXI DE HYDROCHLORI DE, CHLORDI AZEPOXI DE HYDROCHLORI DE
CHLORZOXAZONE, CHLORZOXAZONE
CLONAZEPAM, CLONAZEPAM
CLONI DI NE, CLONI DI NE
DANAZOL, DANAZOL
DEMECLOCYCLI NE HYDROCHLORI DE, DEMECLOCYCLI NE HYDROCHLORI DE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMI NE
DEXTROAMPHETAMI NE SULFATE, DEXTROAMPHETAMI NE SULFATE
DI AZEPAM, DI AZEPAM
DI DANOSI NE, DI DANOSI NE
DI PHENHYDRAMI NE HYDROCHLORI DE, DI PHENHYDRAMI NE HYDROCHLORI DE
DI PYRI DAMOLE, DI PYRI DAMOLE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DROSPI RENONE AND ETHI NYL ESTRADI OL, DROSPI RENONE
DUTASTERI DE, DUTASTERI DE
ERRI N, NORETHI NDRONE
ERYTHROMYCI N ETHYLSUCCI NATE AND SULFI SOXAZOLE ACETYL, ERYTHROMYCI N ETHYLSUCCI NATE
ESTRADI OL AND NORETHI NDRONE ACETATE, ESTRADI OL
ESTRADI OL AND NORGESTI MATE, ESTRADI OL
ESTROPI PATE, ESTROPI PATE
ETHAMBUTOL HYDROCHLORI DE, ETHAMBUTOL HYDROCHLORI DE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 24
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* BARR LABORATORI ES I NC
FEXOFENADI NE HYDROCHLORI DE AND PSEUDOEPHEDRI NE HYDROCHLORI DE, FEXOFENADI NE
FEXOFENADI NE HYDROCHLORI DE, FEXOFENADI NE HYDROCHLORI DE
FLECAI NI DE ACETATE, FLECAI NI DE ACETATE
FLUDROCORTI SONE ACETATE, FLUDROCORTI SONE ACETATE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FLUVOXAMI NE MALEATE, FLUVOXAMI NE MALEATE
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
HYDROMORPHONE HYDROCHLORI DE, HYDROMORPHONE HYDROCHLORI DE
HYDROXYUREA, HYDROXYUREA
HYDROXYZI NE PAMOATE, HYDROXYZI NE PAMOATE
I SONI AZI D, I SONI AZI D
J UNEL 1. 5/ 30, ETHI NYL ESTRADI OL
J UNEL 1/ 20, ETHI NYL ESTRADI OL
J UNEL FE 1. 5/ 30, ETHI NYL ESTRADI OL
J UNEL FE 1/ 20, ETHI NYL ESTRADI OL
KARI VA, DESOGESTREL
KELNOR, ETHI NYL ESTRADI OL
LEFLUNOMI DE, LEFLUNOMI DE
LESSI NA- 28, ETHI NYL ESTRADI OL
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MEFLOQUI NE HYDROCHLORI DE, MEFLOQUI NE HYDROCHLORI DE
MEGESTROL ACETATE, MEGESTROL ACETATE
MEPERI DI NE HYDROCHLORI DE, MEPERI DI NE HYDROCHLORI DE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
METHOTREXATE SODI UM, METHOTREXATE SODI UM
NALTREXONE HYDROCHLORI DE, NALTREXONE HYDROCHLORI DE
NI ACI N, NI ACI N
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
NORETHI NDRONE ACETATE, NORETHI NDRONE ACETATE
NORETHI NDRONE AND ETHI NYL ESTRADI OL AND FERROUS FUMARATE, ETHI NYL ESTRADI OL
NORTREL 0. 5/ 35- 28, ETHI NYL ESTRADI OL
NORTREL 1/ 35- 21, ETHI NYL ESTRADI OL
NORTREL 1/ 35- 28, ETHI NYL ESTRADI OL
NORTREL 7/ 7/ 7, ETHI NYL ESTRADI OL
ONDANSETRON, ONDANSETRON
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
PORTI A- 28, ETHI NYL ESTRADI OL
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
SPRI NTEC, ETHI NYL ESTRADI OL
TEMOZOLOMI DE, TEMOZOLOMI DE
TREXALL, METHOTREXATE SODI UM
TRI - LEGEST 21, ETHI NYL ESTRADI OL
TRI - LEGEST FE, ETHI NYL ESTRADI OL
TRI - SPRI NTEC, ETHI NYL ESTRADI OL
WARFARI N SODI UM, WARFARI N SODI UM
ZONI SAMI DE, ZONI SAMI DE
* BARR PHARMACEUTI CALS
LEUCOVORI N CALCI UM, LEUCOVORI N CALCI UM
BARR LABS DI V TEVA
* BARR LABORATORI ES I NC SUB TEVA PHARMACEUTI CALS USA
ACAMPROSATE CALCI UM, ACAMPROSATE CALCI UM
BARR LABS I NC
* BARR LABORATORI ES I NC
ACI TRETI N, ACI TRETI N
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMI NE
ESTRADI OL, ESTRADI OL
METHYLPHENI DATE HYDROCHLORI DE, METHYLPHENI DATE HYDROCHLORI DE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
NI MODI PI NE, NI MODI PI NE
NORETHI NDRONE ACETATE AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
OLANZAPI NE, OLANZAPI NE
OXYCODONE HYDROCHLORI DE AND I BUPROFEN, I BUPROFEN
TRETI NOI N, TRETI NOI N
BAUSCH AND LOMB



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 25
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* BAUSCH AND LOMB I NC
ALAWAY, KETOTI FEN FUMARATE ( OTC)
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALREX, LOTEPREDNOL ETABONATE
BESI VANCE, BESI FLOXACI N HYDROCHLORI DE
CARTEOLOL HYDROCHLORI DE, CARTEOLOL HYDROCHLORI DE
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
DORZOLAMI DE HYDROCHLORI DE AND TI MOLOL MALEATE, DORZOLAMI DE HYDROCHLORI DE
DORZOLAMI DE HYDROCHLORI DE, DORZOLAMI DE HYDROCHLORI DE
FLURBI PROFEN SODI UM, FLURBI PROFEN SODI UM
I PRATROPI UM BROMI DE, I PRATROPI UM BROMI DE
I STALOL, TI MOLOL MALEATE
LATANOPROST, LATANOPROST
LOTEMAX, LOTEPREDNOL ETABONATE
MI OCHOL- E, ACETYLCHOLI NE CHLORI DE
OFLOXACI N, OFLOXACI N
OPCON- A, NAPHAZOLI NE HYDROCHLORI DE ( OTC)
PROLENSA, BROMFENAC SODI UM
RETI SERT, FLUOCI NOLONE ACETONI DE
TI MOLOL MALEATE, TI MOLOL MALEATE
VI TRASE, HYALURONI DASE
ZI RGAN, GANCI CLOVI R
ZYLET, LOTEPREDNOL ETABONATE
* BAUSCH AND LOMB PHARMACEUTI CALS I NC
ACETI C ACI D 2%I N AQUEOUS ALUMI NUM ACETATE, ACETI C ACI D, GLACI AL
BACI TRACI N ZI NC AND POLYMYXI N B SULFATE, BACI TRACI N ZI NC
BETAXOLOL HYDROCHLORI DE, BETAXOLOL HYDROCHLORI DE
BRI MONI DI NE TARTRATE, BRI MONI DI NE TARTRATE
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
CROLOM, CROMOLYN SODI UM
CROMOLYN SODI UM, CROMOLYN SODI UM
CROMOLYN SODI UM, CROMOLYN SODI UM ( OTC)
DESMOPRESSI N ACETATE, DESMOPRESSI N ACETATE
DEXAMETHASONE SODI UM PHOSPHATE, DEXAMETHASONE SODI UM PHOSPHATE
DEXASPORI N, DEXAMETHASONE
ERYTHROMYCI N, ERYTHROMYCI N
FLUNI SOLI DE, FLUNI SOLI DE
GENTAMI CI N SULFATE, GENTAMI CI N SULFATE
I PRATROPI UM BROMI DE, I PRATROPI UM BROMI DE
LEVOBUNOLOL HYDROCHLORI DE, LEVOBUNOLOL HYDROCHLORI DE
NEOMYCI N AND POLYMYXI N B SULFATES AND BACI TRACI N ZI NC, BACI TRACI N ZI NC
NEOMYCI N AND POLYMYXI N B SULFATES AND DEXAMETHASONE, DEXAMETHASONE
NEOMYCI N AND POLYMYXI N B SULFATES AND GRAMI CI DI N, GRAMI CI DI N
NEOMYCI N AND POLYMYXI N B SULFATES AND HYDROCORTI SONE, HYDROCORTI SONE
NEOMYCI N AND POLYMYXI N B SULFATES, BACI TRACI N ZI NC AND HYDROCORTI SONE, BACI TRACI N ZI NC
OFLOXACI N, OFLOXACI N
OPTI PRANOLOL, METI PRANOLOL HYDROCHLORI DE
OTI CAI R, HYDROCORTI SONE
PENTOLAI R, CYCLOPENTOLATE HYDROCHLORI DE
PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
PROPARACAI NE HYDROCHLORI DE, PROPARACAI NE HYDROCHLORI DE
SULFACETAMI DE SODI UM AND PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
SULFACETAMI DE SODI UM, SULFACETAMI DE SODI UM
TI MOLOL MALEATE, TI MOLOL MALEATE
TOBRAMYCI N AND DEXAMETHASONE, DEXAMETHASONE
TOBRAMYCI N, TOBRAMYCI N
TRI METHOPRI M SULFATE AND POLYMYXI N B SULFATE, POLYMYXI N B SULFATE
TROPI CAMI DE, TROPI CAMI DE
BAXTER HLTHCARE
* BAXTER HEALTHCARE CORP
ACETI C ACI D 0. 25%I N PLASTI C CONTAI NER, ACETI C ACI D, GLACI AL
AMI NOACETI C ACI D 1. 5%I N PLASTI C CONTAI NER, GLYCI NE
ANCEF I N PLASTI C CONTAI NER, CEFAZOLI N SODI UM
BACTOCI LL I N PLASTI C CONTAI NER, OXACI LLI N SODI UM
BRANCHAMI N 4%I N PLASTI C CONTAI NER, AMI NO ACI DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 26
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* BAXTER HEALTHCARE CORP
BREVI BLOC DOUBLE STRENGTH I N PLASTI C CONTAI NER, ESMOLOL HYDROCHLORI DE
BREVI BLOC I N PLASTI C CONTAI NER, ESMOLOL HYDROCHLORI DE
BREVI BLOC, ESMOLOL HYDROCHLORI DE
CARDI OPLEGI C I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
CEFEPI ME I N PLASTI C CONTAI NER, CEFEPI ME HYDROCHLORI DE
CEFTRI AXONE I N PLASTI C CONTAI NER, CEFTRI AXONE SODI UM
CLI NI MI X 2. 75/ 10 SULFI TE FREE I N DEXTROSE 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 2. 75/ 25 SULFI TE FREE I N DEXTROSE 25%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 2. 75/ 5 SULFI TE FREE I N DEXTROSE 5%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 4. 25/ 10 SULFI TE FREE I N DEXTROSE 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 4. 25/ 20 SULFI TE FREE I N DEXTROSE 20%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 4. 25/ 25 SULFI TE FREE I N DEXTROSE 25%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 4. 25/ 5 SULFI TE FREE I N DEXTROSE 5%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 5/ 10 SULFI TE FREE I N DEXTROSE 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 5/ 15 SULFI TE FREE I N DEXTROSE 15%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 5/ 20 SULFI TE FREE I N DEXTROSE 20%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 5/ 25 SULFI TE FREE I N DEXTROSE 25%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X 5/ 35 SULFI TE FREE I N DEXTROSE 35%I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NI MI X E 2. 75/ 10 SULFI TE- FREE W/ ELECT I N DEXTROSE 10%W/ CALCI UM I N PLASTI C
CLI NI MI X E 2. 75/ 25 SULFI TE- FREE W/ ELECT I N DEXTROSE 25%W/ CALCI UM I N PLASTI C
CLI NI MI X E 2. 75/ 5 SULFI TE- FREE W/ ELECT I N DEXTROSE 5%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 4. 25/ 10 SULFI TE- FREE W/ ELECT I N DEXTROSE 10%W/ CALCI UM I N PLASTI C
CLI NI MI X E 4. 25/ 20 SULFI TE- FREE W/ ELECT I N DEXTROSE 20%W/ CALCI UM I N PLASTI C
CLI NI MI X E 4. 25/ 25 SULFI TE- FREE W/ ELECT I N DEXTROSE 25%W/ CALCI UM I N PLASTI C
CLI NI MI X E 4. 25/ 5 SULFI TE- FREE W/ ELECT I N DEXTROSE 5%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 5/ 10 SULFI TE- FREE W/ ELECT I N DEXTROSE 10%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 5/ 15 SULFI TE- FREE W/ ELECT I N DEXTROSE 15%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 5/ 20 SULFI TE- FREE W/ ELECT I N 20%DEXTROSE W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 5/ 25 SULFI TE- FREE W/ ELECT I N DEXTROSE 25%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI MI X E 5/ 35 SULFI TE- FREE W/ ELECT I N DEXTROSE 35%W/ CALCI UM I N PLASTI C CONTAI NER,
CLI NI SOL 15%SULFI TE FREE I N PLASTI C CONTAI NER, AMI NO ACI DS
CLI NOLI PI D 20%, OLI VE OI L
CYCLOPHOSPHAMI DE, CYCLOPHOSPHAMI DE
CYTOXAN ( LYOPHI LI ZED) , CYCLOPHOSPHAMI DE
DEXTROSE 10%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 10%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 2. 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 20%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 30%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 40%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND ELECTROLYTE NO 75 I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND ELECTROLYTE NO. 48 I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND POTASSI UM CHLORI DE 0. 075%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND POTASSI UM CHLORI DE 0. 15%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND POTASSI UM CHLORI DE 0. 224%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND POTASSI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DEXTROSE 5%I N SODI UM CHLORI DE 0. 2%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N SODI UM CHLORI DE 0. 33%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 10MEQ, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 15MEQ ( K) , DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 20MEQ ( K) , DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 20MEQ, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 30MEQ, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 40MEQ, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 5MEQ ( K) , DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 2%AND POTASSI UM CHLORI DE 5MEQ, DEXTROSE
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 10MEQ I N PLASTI C CONTAI NER,
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 15MEQ I N PLASTI C CONTAI NER,
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 20MEQ I N PLASTI C CONTAI NER,
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 30MEQ I N PLASTI C CONTAI NER,
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 27
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* BAXTER HEALTHCARE CORP
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 40MEQ I N PLASTI C CONTAI NER,
DEXTROSE 5%, SODI UM CHLORI DE 0. 33%AND POTASSI UM CHLORI DE 5MEQ I N PLASTI C CONTAI NER,
DEXTROSE 5%, SODI UM CHLORI DE 0. 45%AND POTASSI UM CHLORI DE 20MEQ ( K) I N PLASTI C
DEXTROSE 50%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 60%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 70%I N PLASTI C CONTAI NER, DEXTROSE
DI ANEAL 137 W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL 137 W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL 137 W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL LOWCALCI UM W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL LOWCALCI UM W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL LOWCALCI UM W/ DEXTROSE 3. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL LOWCALCI UM W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 1 W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 1 W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 1 W/ DEXTROSE 3. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 1 W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 2 W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 2 W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 2 W/ DEXTROSE 3. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DI ANEAL PD- 2 W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DOBUTAMI NE HYDROCHLORI DE I N DEXTROSE 5%I N PLASTI C CONTAI NER, DOBUTAMI NE HYDROCHLORI DE
DOPAMI NE HYDROCHLORI DE I N DEXTROSE 5%I N PLASTI C CONTAI NER, DOPAMI NE HYDROCHLORI DE
ETHRANE, ENFLURANE
EXTRANEAL, I CODEXTRI N
FAMOTI DI NE PRESERVATI VE FREE I N PLASTI C CONTAI NER, FAMOTI DI NE
FLAGYL I . V. RTU I N PLASTI C CONTAI NER, METRONI DAZOLE
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, FLUCONAZOLE
FORANE, I SOFLURANE
HEPARI N SODI UM 1, 000 UNI TS AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, HEPARI N
HEPARI N SODI UM 2, 000 UNI TS AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, HEPARI N
HEPATASOL 8%, AMI NO ACI DS
I FEX, I FOSFAMI DE
I SOTONI C GENTAMI CI N SULFATE I N PLASTI C CONTAI NER, GENTAMI CI N SULFATE
LACTATED RI NGER' S AND DEXTROSE 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
LACTATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
LI DOCAI NE HYDROCHLORI DE 0. 2%AND DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE
LI DOCAI NE HYDROCHLORI DE 0. 4%AND DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE
LI DOCAI NE HYDROCHLORI DE 0. 8%AND DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE
MESNEX, MESNA
MI LRI NONE LACTATE I N DEXTROSE 5%I N PLASTI C CONTAI NER, MI LRI NONE LACTATE
NALLPEN I N PLASTI C CONTAI NER, NAFCI LLI N SODI UM
NEXTERONE, AMI ODARONE HYDROCHLORI DE
NI TROGLYCERI N I N DEXTROSE 5%, NI TROGLYCERI N
OSMI TROL 10%I N WATER I N PLASTI C CONTAI NER, MANNI TOL
OSMI TROL 10%I N WATER, MANNI TOL
OSMI TROL 15%I N WATER I N PLASTI C CONTAI NER, MANNI TOL
OSMI TROL 15%I N WATER, MANNI TOL
OSMI TROL 20%I N WATER I N PLASTI C CONTAI NER, MANNI TOL
OSMI TROL 20%I N WATER, MANNI TOL
OSMI TROL 5%I N WATER I N PLASTI C CONTAI NER, MANNI TOL
OSMI TROL 5%I N WATER, MANNI TOL
PENI CI LLI N G POTASSI UM I N PLASTI C CONTAI NER, PENI CI LLI N G POTASSI UM
PLASMA- LYTE 148 AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
PLASMA- LYTE 148 I N WATER I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
PLASMA- LYTE 56 AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
PLASMA- LYTE 56 I N PLASTI C CONTAI NER, MAGNESI UM ACETATE TETRAHYDRATE
PLASMA- LYTE A I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
PLASMA- LYTE M AND DEXTROSE 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PLASMA- LYTE R I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
POTASSI UM CHLORI DE 0. 15%I N SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, POTASSI UM
POTASSI UM CHLORI DE 0. 15%I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, POTASSI UM
POTASSI UM CHLORI DE 0. 224%I N SODI UM CHLORI DE 0. 9%, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 0. 3%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, POTASSI UM
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 28
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* BAXTER HEALTHCARE CORP
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 10MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 15MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 30MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE, POTASSI UM CHLORI DE
PREMASOL 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
PREMASOL 6%I N PLASTI C CONTAI NER, AMI NO ACI DS
RENAMI N W/ O ELECTROLYTES, AMI NO ACI DS
RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
SEVOFLURANE, SEVOFLURANE
SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE 0. 9%I N STERI LE PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE 3%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE 5%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM LACTATE 0. 167 MOLAR I N PLASTI C CONTAI NER, SODI UM LACTATE
SORBI TOL 3%I N PLASTI C CONTAI NER, SORBI TOL
STERI LE WATER FOR I NJ ECTI ON I N PLASTI C CONTAI NER, STERI LE WATER FOR I NJ ECTI ON
STERI LE WATER I N PLASTI C CONTAI NER, STERI LE WATER FOR I RRI GATI ON
STERI LE WATER, STERI LE WATER FOR I RRI GATI ON
SUPRANE, DESFLURANE
TI S- U- SOL I N PLASTI C CONTAI NER, MAGNESI UM SULFATE
TI S- U- SOL, MAGNESI UM SULFATE
TRAVASOL 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 10%W/ O ELECTROLYTES, AMI NO ACI DS
TRAVASOL 3. 5%SULFI TE FREE W/ ELECTROLYTES I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 3. 5%W/ ELECTROLYTES, AMI NO ACI DS
TRAVASOL 5. 5%I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 5. 5%SULFI TE FREE W/ ELECTROLYTES I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 5. 5%W/ ELECTROLYTES, AMI NO ACI DS
TRAVASOL 5. 5%W/ O ELECTROLYTES, AMI NO ACI DS
TRAVASOL 8. 5%I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 8. 5%SULFI TE FREE W/ ELECTROLYTES I N PLASTI C CONTAI NER, AMI NO ACI DS
TRAVASOL 8. 5%W/ ELECTROLYTES, AMI NO ACI DS
TRAVASOL 8. 5%W/ O ELECTROLYTES, AMI NO ACI DS
VANCOCI N HYDROCHLORI DE I N PLASTI C CONTAI NER, VANCOMYCI N HYDROCHLORI DE
* BAXTER HEALTHCARE I NTERNATI 0NAL SPECI ALTY THERAPI ES DI V
PROSOL 20%SULFI TE FREE I N PLASTI C CONTAI NER, AMI NO ACI DS
BAXTER HLTHCARE CORP
* BAXTER HEALTHCARE CORP ANESTHESI A AND CRI TI CAL CARE
PROTOPAM CHLORI DE, PRALI DOXI ME CHLORI DE
* BAXTER HEALTHCARE CORP ANESTHESI A CRI TI CAL CARE
ATI VAN, LORAZEPAM
OXYTOCI N, OXYTOCI N
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
REGLAN, METOCLOPRAMI DE HYDROCHLORI DE
BAYER
* BAYER HEALTHCARE LLC









34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 29
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* BAYER HEALTHCARE LLC
ALEVE, NAPROXEN SODI UM ( OTC)
ALEVE- D SI NUS & COLD, NAPROXEN SODI UM ( OTC)
FEMSTAT 3, BUTOCONAZOLE NI TRATE ( OTC)
MYCELEX- 7 COMBI NATI ON PACK, CLOTRI MAZOLE ( OTC)
MYCELEX- 7, CLOTRI MAZOLE ( OTC)
RI D MOUSSE, PI PERONYL BUTOXI DE ( OTC)
BAYER HLTHCARE
* BAYER HEALTHCARE PHARMACEUTI CALS I NC
ADALAT CC, NI FEDI PI NE
ADEMPAS, RI OCI GUAT
ANGELI Q, DROSPI RENONE
AVELOX I N SODI UM CHLORI DE 0. 8%I N PLASTI C CONTAI NER, MOXI FLOXACI N HYDROCHLORI DE
AVELOX, MOXI FLOXACI N HYDROCHLORI DE
BETAPACE AF, SOTALOL HYDROCHLORI DE
BETAPACE, SOTALOL HYDROCHLORI DE
BEYAZ, DROSPI RENONE
BI LTRI CI DE, PRAZI QUANTEL
CI PRO I N DEXTROSE 5%I N PLASTI C CONTAI NER, CI PROFLOXACI N
CI PRO, CI PROFLOXACI N
CI PRO, CI PROFLOXACI N HYDROCHLORI DE
CLI MARA PRO, ESTRADI OL
CLI MARA, ESTRADI OL
DESONATE, DESONI DE
DTI C- DOME, DACARBAZI NE
EOVI ST, GADOXETATE DI SODI UM
FI NACEA, AZELAI C ACI D
GADAVI ST, GADOBUTROL
LEVI TRA, VARDENAFI L HYDROCHLORI DE
MAGNEVI ST, GADOPENTETATE DI MEGLUMI NE
MENOSTAR, ESTRADI OL
MI RENA, LEVONORGESTREL
NATAZI A, DI ENOGEST
NEXAVAR, SORAFENI B TOSYLATE
PRECOSE, ACARBOSE
SAFYRAL, DROSPI RENONE
SKYLA, LEVONORGESTREL
STAXYN, VARDENAFI L HYDROCHLORI DE
STI VARGA, REGORAFENI B
ULTRAVI ST ( PHARMACY BULK) , I OPROMI DE
ULTRAVI ST 150, I OPROMI DE
ULTRAVI ST 240, I OPROMI DE
ULTRAVI ST 300 I N PLASTI C CONTAI NER, I OPROMI DE
ULTRAVI ST 300, I OPROMI DE
ULTRAVI ST 370, I OPROMI DE
XOFI GO, RADI UM RA- 223 DI CHLORI DE
YASMI N, DROSPI RENONE
YAZ, DROSPI RENONE
BAYSHORE PHARMS LLC
* BAYSHORE PHARMACEUTI CALS LLC
METHSCOPOLAMI NE BROMI DE, METHSCOPOLAMI NE BROMI DE
BD RX
* BD RX I NC
DI PHENHYDRAMI NE HYDROCHLORI DE PRESERVATI VE FREE, DI PHENHYDRAMI NE HYDROCHLORI DE
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
MORPHI NE SULFATE, MORPHI NE SULFATE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
BECTON DI CKI NSON
* BECTON DI CKI NSON AND CO
CHLORHEXI DI NE GLUCONATE, CHLORHEXI DI NE GLUCONATE ( OTC)
E- Z SCRUB 201, POVI DONE- I ODI NE ( OTC)
E- Z SCRUB 241, POVI DONE- I ODI NE ( OTC)
BEDFORD
* BEDFORD LABORATORI ES DI V BEN VENUE LABORATORI ES I NC
ACETAZOLAMI DE SODI UM, ACETAZOLAMI DE SODI UM
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 30
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* BEDFORD LABORATORI ES DI V BEN VENUE LABORATORI ES I NC
ACETYLCYSTEI NE, ACETYLCYSTEI NE
ACYCLOVI R SODI UM, ACYCLOVI R SODI UM
ADENOSI NE, ADENOSI NE
ALPROSTADI L, ALPROSTADI L
AMI KACI N SULFATE, AMI KACI N SULFATE
AMRI NONE LACTATE, I NAMRI NONE LACTATE
ATRACURI UM BESYLATE PRESERVATI VE FREE, ATRACURI UM BESYLATE
ATRACURI UM BESYLATE, ATRACURI UM BESYLATE
AZATHI OPRI NE SODI UM, AZATHI OPRI NE SODI UM
AZTREONAM, AZTREONAM
BLEOMYCI N SULFATE, BLEOMYCI N SULFATE
BUMETANI DE, BUMETANI DE
BUPRENORPHI NE HYDROCHLORI DE, BUPRENORPHI NE HYDROCHLORI DE
BUTORPHANOL TARTRATE PRESERVATI VE FREE, BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CARBOPLATI N, CARBOPLATI N
CEFTRI AXONE, CEFTRI AXONE SODI UM
CERUBI DI NE, DAUNORUBI CI N HYDROCHLORI DE
CHLOROPROCAI NE HYDROCHLORI DE, CHLOROPROCAI NE HYDROCHLORI DE
CI SPLATI N, CI SPLATI N
CLADRI BI NE, CLADRI BI NE
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
CYCLOSPORI NE, CYCLOSPORI NE
CYTARABI NE, CYTARABI NE
DACARBAZI NE, DACARBAZI NE
DACTI NOMYCI N, DACTI NOMYCI N
DAUNORUBI CI N HYDROCHLORI DE, DAUNORUBI CI N HYDROCHLORI DE
DEFEROXAMI NE MESYLATE, DEFEROXAMI NE MESYLATE
DEXRAZOXANE HYDROCHLORI DE, DEXRAZOXANE HYDROCHLORI DE
DI CYCLOMI NE HYDROCHLORI DE ( PRESERVATI VE- FREE) , DI CYCLOMI NE HYDROCHLORI DE
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
DI PYRI DAMOLE, DI PYRI DAMOLE
DOBUTAMI NE HYDROCHLORI DE, DOBUTAMI NE HYDROCHLORI DE
DOXAPRAM HYDROCHLORI DE, DOXAPRAM HYDROCHLORI DE
DOXORUBI CI N HYDROCHLORI DE, DOXORUBI CI N HYDROCHLORI DE
DOXYCYCLI NE, DOXYCYCLI NE HYCLATE
ENALAPRI LAT, ENALAPRI LAT
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
ETOMI DATE, ETOMI DATE
ETOPOSI DE, ETOPOSI DE
FAMOTI DI NE PRESERVATI VE FREE, FAMOTI DI NE
FAMOTI DI NE, FAMOTI DI NE
FLOXURI DI NE, FLOXURI DI NE
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%, FLUCONAZOLE
FLUPHENAZI NE DECANOATE, FLUPHENAZI NE DECANOATE
FOSPHENYTOI N SODI UM, FOSPHENYTOI N SODI UM
HALOPERI DOL DECANOATE, HALOPERI DOL DECANOATE
HALOPERI DOL, HALOPERI DOL LACTATE
I NDOMETHACI N SODI UM, I NDOMETHACI N SODI UM
KETAMI NE HYDROCHLORI DE, KETAMI NE HYDROCHLORI DE
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
LABETALOL HYDROCHLORI DE, LABETALOL HYDROCHLORI DE
LEUCOVORI N CALCI UM PRESERVATI VE FREE, LEUCOVORI N CALCI UM
LEUCOVORI N CALCI UM, LEUCOVORI N CALCI UM
LEVOCARNI TI NE, LEVOCARNI TI NE
MESNA, MESNA
METHOTREXATE SODI UM PRESERVATI VE FREE, METHOTREXATE SODI UM
METHOTREXATE SODI UM, METHOTREXATE SODI UM
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
MI LRI NONE LACTATE, MI LRI NONE LACTATE
MI TOMYCI N, MI TOMYCI N
MI TOXANTRONE HYDROCHLORI DE, MI TOXANTRONE HYDROCHLORI DE
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
NOREPI NEPHRI NE BI TARTRATE, NOREPI NEPHRI NE BI TARTRATE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 31
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* BEDFORD LABORATORI ES DI V BEN VENUE LABORATORI ES I NC
OCTREOTI DE ACETATE ( PRESERVATI VE FREE) , OCTREOTI DE ACETATE
OCTREOTI DE ACETATE, OCTREOTI DE ACETATE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
PACLI TAXEL, PACLI TAXEL
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
PHENTOLAMI NE MESYLATE, PHENTOLAMI NE MESYLATE
POLYMYXI N B SULFATE, POLYMYXI N B SULFATE
PROCHLORPERAZI NE EDI SYLATE, PROCHLORPERAZI NE EDI SYLATE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RI FAMPI N, RI FAMPI N
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TERBUTALI NE SULFATE, TERBUTALI NE SULFATE
TESTOSTERONE CYPI ONATE, TESTOSTERONE CYPI ONATE
THI OTEPA, THI OTEPA
VALPROATE SODI UM, VALPROATE SODI UM
VECURONI UM BROMI DE, VECURONI UM BROMI DE
VI NBLASTI NE SULFATE, VI NBLASTI NE SULFATE
VI NORELBI NE TARTRATE, VI NORELBI NE TARTRATE
BEDFORD LABS
* BEDFORD LABORATORI ES
ALLOPURI NOL SODI UM, ALLOPURI NOL SODI UM
CAFCI T, CAFFEI NE CI TRATE
CARBOPLATI N, CARBOPLATI N
DI HYDROERGOTAMI NE MESYLATE, DI HYDROERGOTAMI NE MESYLATE
ESMOLOL HYDROCHLORI DE, ESMOLOL HYDROCHLORI DE
FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, FLUCONAZOLE
FLUMAZENI L, FLUMAZENI L
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
I DARUBI CI N HYDROCHLORI DE, I DARUBI CI N HYDROCHLORI DE
I FOSFAMI DE, I FOSFAMI DE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
LORAZEPAM PRESERVATI VE FREE, LORAZEPAM
MELPHALAN HYDROCHLORI DE, MELPHALAN HYDROCHLORI DE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MI LRI NONE LACTATE I N DEXTROSE 5%I N PLASTI C CONTAI NER, MI LRI NONE LACTATE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ORPHENADRI NE CI TRATE, ORPHENADRI NE CI TRATE
PENTOSTATI N, PENTOSTATI N
TORSEMI DE, TORSEMI DE
BELCHER PHARMS
* BELCHER PHARMACEUTI CALS LLC
CEPHALEXI N, CEPHALEXI N
DESLORATADI NE, DESLORATADI NE
BEN VENUE
* BEN VENUE LABORATORI ES I NC
FAMOTI DI NE PRESERVATI VE FREE, FAMOTI DI NE
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
BEXI MCO USA
* BEXI MCO PHARMACEUTI CALS USA I NC
CARVEDI LOL, CARVEDI LOL
BI CON PHARM
* BI CON PHARMACEUTI CAL I NC
FOLI C ACI D, FOLI C ACI D
BI O NUCLEONI CS
* BI O NUCLEONI CS I NC
STRONTI UM CHLORI DE SR- 89, STRONTI UM CHLORI DE SR- 89
BI O PHARM I NC
* BI O PHARM I NC
CETI RI ZI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 32
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* BI O PHARM I NC
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RI SPERI DONE, RI SPERI DONE
BI OCODEX I NC
* BI OCODEX I NC
TOTECT, DEXRAZOXANE HYDROCHLORI DE
BI OGEN I DEC I NC
* BI OGEN I DEC I NC
TECFI DERA, DI METHYL FUMARATE
BI OKEY
* BI OKEY I NC
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
CI LOSTAZOL, CI LOSTAZOL
BI OMARI N PHARM
* BI OMARI N PHARMACEUTI CAL I NC
KUVAN, SAPROPTERI N DI HYDROCHLORI DE
BLAI REX
* BLAI REX LABORATORI ES I NC
BRONCHO SALI NE, SODI UM CHLORI DE ( OTC)
BLU CARI BE
* BLU CARI BE I NC
GEMFI BROZI L, GEMFI BROZI L
SI MVASTATI N, SI MVASTATI N
BLU CARI BE I NC
* BLU CARI BE I NC
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
BOCA PHARMA LLC
* BOCA PHARMACAL LLC
ALPRAZOLAM, ALPRAZOLAM
CARBI NOXAMI NE MALEATE, CARBI NOXAMI NE MALEATE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
LEVETI RACETAM, LEVETI RACETAM
METHI MAZOLE, METHI MAZOLE
METHSCOPOLAMI NE BROMI DE, METHSCOPOLAMI NE BROMI DE
BOEHRI NGER I NGELHEI M
* BOEHRI NGER I NGELHEI M
CATAPRES, CLONI DI NE HYDROCHLORI DE
CATAPRES- TTS- 1, CLONI DI NE
CATAPRES- TTS- 2, CLONI DI NE
CATAPRES- TTS- 3, CLONI DI NE
GI LOTRI F, AFATI NI B DI MALEATE
MI CARDI S HCT, HYDROCHLOROTHI AZI DE
MI CARDI S, TELMI SARTAN
MI RAPEX, PRAMI PEXOLE DI HYDROCHLORI DE
ZANTAC 150, RANI TI DI NE HYDROCHLORI DE ( OTC)
ZANTAC 75, RANI TI DI NE HYDROCHLORI DE ( OTC)
* BOEHRI NGER I NGELHEI M PHARMACEUTI CALS I NC
AGGRENOX, ASPI RI N
APTI VUS, TI PRANAVI R
ATROVENT HFA, I PRATROPI UM BROMI DE
ATROVENT, I PRATROPI UM BROMI DE
COMBI VENT RESPI MAT, ALBUTEROL SULFATE
COMBI VENT, ALBUTEROL SULFATE
FLOMAX, TAMSULOSI N HYDROCHLORI DE
J ENTADUETO, LI NAGLI PTI N
MI RAPEX ER, PRAMI PEXOLE DI HYDROCHLORI DE
MOBI C, MELOXI CAM
PERSANTI NE, DI PYRI DAMOLE
PRADAXA, DABI GATRAN ETEXI LATE MESYLATE
SPI RI VA, TI OTROPI UM BROMI DE MONOHYDRATE
TRADJ ENTA, LI NAGLI PTI N
TWYNSTA, AMLODI PI NE BESYLATE
VI RAMUNE XR, NEVI RAPI NE
VI RAMUNE, NEVI RAPI NE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 33
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
BRACCO
* BRACCO DI AGNOSTI CS I NC
CARDI OGEN- 82, RUBI DI UM CHLORI DE RB- 82
CHOLETEC, TECHNETI UM TC- 99M MEBROFENI N KI T
CHOLOGRAFI N MEGLUMI NE, I ODI PAMI DE MEGLUMI NE
CYSTOGRAFI N DI LUTE, DI ATRI ZOATE MEGLUMI NE
CYSTOGRAFI N, DI ATRI ZOATE MEGLUMI NE
GASTROGRAFI N, DI ATRI ZOATE MEGLUMI NE
I SOVUE- 200, I OPAMI DOL
I SOVUE- 250, I OPAMI DOL
I SOVUE- 300, I OPAMI DOL
I SOVUE- 370, I OPAMI DOL
I SOVUE- M 200, I OPAMI DOL
I SOVUE- M 300, I OPAMI DOL
KI NEVAC, SI NCALI DE
MDP- BRACCO, TECHNETI UM TC- 99M MEDRONATE KI T
MULTI HANCE MULTI PACK, GADOBENATE DI MEGLUMI NE
MULTI HANCE, GADOBENATE DI MEGLUMI NE
PROHANCE MULTI PACK, GADOTERI DOL
PROHANCE, GADOTERI DOL
RENOGRAFI N- 76, DI ATRI ZOATE MEGLUMI NE
SI NOGRAFI N, DI ATRI ZOATE MEGLUMI NE
BRAI NTREE
* BRAI NTREE LABORATORI ES I NC
AXI D, NI ZATI DI NE
GOLYTELY, POLYETHYLENE GLYCOL 3350
HALFLYTELY, BI SACODYL
NULYTELY, POLYETHYLENE GLYCOL 3350
NULYTELY- FLAVORED, POLYETHYLENE GLYCOL 3350
BRAI NTREE LABS
* BRAI NTREE LABORATORI ES I NC
SUCLEAR, MAGNESI UM SULFATE
SUPREP BOWEL PREP KI T, MAGNESI UM SULFATE ANHYDROUS
BRECKENRI DGE PHARM
* BRECKENRI DGE PHARMACEUTI CAL I NC
CETI RI ZI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CI LOSTAZOL, CI LOSTAZOL
EPI NASTI NE HYDROCHLORI DE, EPI NASTI NE HYDROCHLORI DE
ESTRADI OL AND NORETHI NDRONE ACETATE, ESTRADI OL
LEVETI RACETAM, LEVETI RACETAM
MEFENAMI C ACI D, MEFENAMI C ACI D
MELOXI CAM, MELOXI CAM
METHSCOPOLAMI NE BROMI DE, METHSCOPOLAMI NE BROMI DE
OXCARBAZEPI NE, OXCARBAZEPI NE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
BRI STOL MYERS SQUI BB
* BRI STOL MYERS SQUI BB
AZACTAM, AZTREONAM
BARACLUDE, ENTECAVI R
GLUCOVANCE, GLYBURI DE
KOMBI GLYZE XR, METFORMI N HYDROCHLORI DE
LYSODREN, MI TOTANE
MEGACE, MEGESTROL ACETATE
PRAVACHOL, PRAVASTATI N SODI UM
* BRI STOL MYERS SQUI BB CO
AZACTAM I N PLASTI C CONTAI NER, AZTREONAM
DROXI A, HYDROXYUREA
GLUCOPHAGE XR, METFORMI N HYDROCHLORI DE
HYDREA, HYDROXYUREA
I XEMPRA KI T, I XABEPI LONE
ONGLYZA, SAXAGLI PTI N HYDROCHLORI DE
REYATAZ, ATAZANAVI R SULFATE







34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 34
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * B * *
* BRI STOL MYERS SQUI BB CO
SPRYCEL, DASATI NI B
SUSTI VA, EFAVI RENZ
VI DEX EC, DI DANOSI NE
* BRI STOL MYERS SQUI BB CO PHARMACEUTI CAL RESEARCH I NSTI TUTE
ELI QUI S, API XABAN
ETOPOPHOS PRESERVATI VE FREE, ETOPOSI DE PHOSPHATE
GLUCOPHAGE, METFORMI N HYDROCHLORI DE
VI DEX, DI DANOSI NE
ZERI T, STAVUDI NE
* BRI STOL MYERS SQUI BB PHARMA CO
COUMADI N, WARFARI N SODI UM
BRYAN
* BRYAN CORP
SCLEROSOL, TALC
TALC, TALC
* * C * *
CADENCE PHARMS
* CADENCE PHARMACEUTI CALS I NC
OFI RMEV, ACETAMI NOPHEN
CADI LA PHARMS LTD
* CADI LA PHARMACEUTI CALS LTD
ACYCLOVI R, ACYCLOVI R
CADI STA PHARMS
* CADI STA PHARMACEUTI CALS I NC
ALENDRONATE SODI UM, ALENDRONATE SODI UM
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES, CETI RI ZI NE HYDROCHLORI DE ( OTC)
LAMOTRI GI NE, LAMOTRI GI NE
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
OXCARBAZEPI NE, OXCARBAZEPI NE
CARACO
* CARACO PHARMACEUTI CAL LABORATORI ES LTD
ALLOPURI NOL, ALLOPURI NOL
AMI TRI PTYLI NE HYDROCHLORI DE, AMI TRI PTYLI NE HYDROCHLORI DE
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
ATENOLOL, ATENOLOL
BACLOFEN, BACLOFEN
BENZONATATE, BENZONATATE
BETHANECHOL CHLORI DE, BETHANECHOL CHLORI DE
CARVEDI LOL, CARVEDI LOL
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
CLONAZEPAM, CLONAZEPAM
CLOZAPI NE, CLOZAPI NE
ELI XOPHYLLI N, THEOPHYLLI NE
FLUMADI NE, RI MANTADI NE HYDROCHLORI DE
FLURBI PROFEN, FLURBI PROFEN
GEMFI BROZI L, GEMFI BROZI L
GLI PI ZI DE AND METFORMI N HYDROCHLORI DE, GLI PI ZI DE
GLI PI ZI DE, GLI PI ZI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
I NDOMETHACI N, I NDOMETHACI N
I SOSORBI DE DI NI TRATE, I SOSORBI DE DI NI TRATE
MELOXI CAM, MELOXI CAM
MEPERI DI NE HYDROCHLORI DE, MEPERI DI NE HYDROCHLORI DE







34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 35
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * C * *
* CARACO PHARMACEUTI CAL LABORATORI ES LTD
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
METHI MAZOLE, METHI MAZOLE
METHYLPHENI DATE HYDROCHLORI DE, METHYLPHENI DATE HYDROCHLORI DE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
MI RTAZAPI NE, MI RTAZAPI NE
NI TROFURANTOI N, NI TROFURANTOI N
OXAPROZI N, OXAPROZI N
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
PAROMOMYCI N SULFATE, PAROMOMYCI N SULFATE
PAROXETI NE HYDROCHLORI DE, PAROXETI NE HYDROCHLORI DE
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
PROMETHAZI NE HYDROCHLORI DE AND CODEI NE PHOSPHATE, CODEI NE PHOSPHATE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
REPAGLI NI DE, REPAGLI NI DE
SYNALGOS- DC, ASPI RI N
THEOCHRON, THEOPHYLLI NE
TI CLOPI DI NE HYDROCHLORI DE, TI CLOPI DI NE HYDROCHLORI DE
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
TRAMADOL HYDROCHLORI DE AND ACETAMI NOPHEN, ACETAMI NOPHEN
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
VERAPAMI L HYDROCHLORI DE, VERAPAMI L HYDROCHLORI DE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
CARDI NAL HEALTH 4 1 4
* CARDI NAL HEALTH 414 LLC
TECHNETI UM TC 99M SESTAMI BI , TECHNETI UM TC- 99M SESTAMI BI KI T
* CARDI NAL HEALTH 414 LLC CARDI NAL HEALTH NUCLEAR PHARMACY SERVI CES
AMMONI A N 13, AMMONI A N- 13
CARDI NAL HLTH 4 1 4
* CARDI NAL HEALTH 414
SODI UM I ODI DE I 123, SODI UM I ODI DE I - 123
CAREFUSI ON
* CAREFUSI ON 213 LLC
CHLORAPREP ONE- STEP FREPP, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORAPREP ONE- STEP SEPP, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORAPREP ONE- STEP, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORAPREP SI NGLE SWABSTI CK, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORAPREP TRI PLE SWABSTI CK, CHLORHEXI DI NE GLUCONATE ( OTC)
CHLORAPREP WI TH TI NT, CHLORHEXI DI NE GLUCONATE ( OTC)
PHARMASEAL SCRUB CARE, CHLORHEXI DI NE GLUCONATE ( OTC)
CARLSBAD
* CARLSBAD TECHNOLOGY I NC
ACYCLOVI R, ACYCLOVI R
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
FAMOTI DI NE, FAMOTI DI NE
GLI MEPI RI DE, GLI MEPI RI DE
LOVASTATI N, LOVASTATI N
MELOXI CAM, MELOXI CAM
MODAFI NI L, MODAFI NI L
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
CAROLI NA MEDCL
* CAROLI NA MEDI CAL PRODUCTS CO
AMANTADI NE HYDROCHLORI DE, AMANTADI NE HYDROCHLORI DE
HYDROCORTI SONE I N ABSORBASE, HYDROCORTI SONE
I SONI AZI D, I SONI AZI D
SODI UM POLYSTYRENE SULFONATE, SODI UM POLYSTYRENE SULFONATE
SPS, SODI UM POLYSTYRENE SULFONATE
TRI AMCI NOLONE ACETONI DE I N ABSORBASE, TRI AMCI NOLONE ACETONI DE
CATALENT
* CATALENT PHARMA SOLUTI ONS LLC


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 36
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * C * *
* CATALENT PHARMA SOLUTI ONS LLC
VALPROI C ACI D, VALPROI C ACI D
CEDAR PHARMS
* CEDAR PHARMACEUTI CALS LLC
METHI MAZOLE, METHI MAZOLE
SODI UM POLYSTYRENE SULFONATE, SODI UM POLYSTYRENE SULFONATE
CELGENE
* CELGENE CORP
I STODAX, ROMI DEPSI N
POMALYST, POMALI DOMI DE
REVLI MI D, LENALI DOMI DE
THALOMI D, THALI DOMI DE
VI DAZA, AZACI TI DI NE
CEPHALON
* CEPHALON I NC
ACTI Q, FENTANYL CI TRATE
FENTORA, FENTANYL CI TRATE
GABI TRI L, TI AGABI NE HYDROCHLORI DE
NUVI GI L, ARMODAFI NI L
PROVI GI L, MODAFI NI L
TREANDA, BENDAMUSTI NE HYDROCHLORI DE
TRI SENOX, ARSENI C TRI OXI DE
CEREXA
* CEREXA I NC
TEFLARO, CEFTAROLI NE FOSAMI L
CHARTWELL LI FE SCI
* CHARTWELL LI FE SCI ENCE LLC
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
DOXYCYCLI NE, DOXYCYCLI NE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
CHATTEM
* CHATTEM I NC
SELSUN, SELENI UM SULFI DE
UNI SOM, DOXYLAMI NE SUCCI NATE ( OTC)
CHEMI SCH FBRK KRSSLR
* CHEMI SCHE FABRI K KREUSSLER & CO. GMBH
ASCLERA, POLI DOCANOL
CHI RHOCLI N
* CHI RHOCLI N I NC
CHI RHOSTI M, SECRETI N SYNTHETI C HUMAN
CI PHER PHARMS I NC
* CI PHER PHARMACEUTI CALS I NC
CONZI P, TRAMADOL HYDROCHLORI DE
LI POFEN, FENOFI BRATE
CI PLA
* CI PLA LTD
NEVI RAPI NE, NEVI RAPI NE
RI SPERI DONE, RI SPERI DONE
ZI DOVUDI NE, ZI DOVUDI NE
CI PLA LTD
* CI PLA LTD
ALBUTEROL SULFATE AND I PRATROPI UM BROMI DE, ALBUTEROL SULFATE
ALENDRONATE SODI UM, ALENDRONATE SODI UM
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
CARBOPLATI N, CARBOPLATI N
CARVEDI LOL, CARVEDI LOL
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CI CLOPI ROX, CI CLOPI ROX
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
FAMCI CLOVI R, FAMCI CLOVI R
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 37
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * C * *
* CI PLA LTD
I RBESARTAN, I RBESARTAN
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
LAMOTRI GI NE, LAMOTRI GI NE
LEVALBUTEROL HYDROCHLORI DE, LEVALBUTEROL HYDROCHLORI DE
LEVOFLOXACI N, LEVOFLOXACI N
MELOXI CAM, MELOXI CAM
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
STAVUDI NE, STAVUDI NE
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
TOPI RAMATE, TOPI RAMATE
ZALEPLON, ZALEPLON
ZI DOVUDI NE, ZI DOVUDI NE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
CI TI US PHARMS
* CI TI US PHARMACEUTI CALS LLC
SUPRENZA, PHENTERMI NE HYDROCHLORI DE
CI TRON PHARMA LLC
* CI TRON PHARMA LLC
ANTI VERT, MECLI ZI NE HYDROCHLORI DE
CORTI SPORI N, HYDROCORTI SONE
THALI TONE, CHLORTHALI DONE
CLARI S LI FESCI ENCES
* CLARI S LI FESCI ENCES LI MI TED
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
* CLARI S LI FESCI ENCES LTD
CI PROFLOXACI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, CI PROFLOXACI N
CI PROFLOXACI N, CI PROFLOXACI N
FLUCONAZOLE I N DEXTROSE 5%I N PLASTI C CONTAI NER, FLUCONAZOLE
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, FLUCONAZOLE
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%, FLUCONAZOLE
LEVOFLOXACI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, LEVOFLOXACI N
LEVOFLOXACI N, LEVOFLOXACI N
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONI DAZOLE I N PLASTI C CONTAI NER, METRONI DAZOLE
NOREPI NEPHRI NE BI TARTRATE, NOREPI NEPHRI NE BI TARTRATE
CLI NI GEN HLTHCARE
* CLI NI GEN HEALTHCARE LTD
FOSCAVI R, FOSCARNET SODI UM
CLONMEL HLTHCARE
* CLONMEL HEALTHCARE LTD
MORPHI NE SULFATE, MORPHI NE SULFATE
CLOVER PHARMS
* CLOVER PHARMACEUTI CALS CORP
AMI CAR, AMI NOCAPROI C ACI D
CNTY LI NE PHARMS
* COUNTY LI NE PHARMACEUTI CALS LLC
UREX, METHENAMI NE HI PPURATE
COASTAL PHARMS
* COASTAL PHARMACEUTI CALS
BROMFENAC SODI UM, BROMFENAC SODI UM
LI OTHYRONI NE SODI UM, LI OTHYRONI NE SODI UM
METHAMPHETAMI NE HYDROCHLORI DE, METHAMPHETAMI NE HYDROCHLORI DE
NYSTATI N, NYSTATI N
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
OXYCODONE AND ASPI RI N, ASPI RI N
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
COLGATE
* COLGATE ORAL PHARMACEUTI CALS I NC
PERI OGARD, CHLORHEXI DI NE GLUCONATE
COLGATE PALMOLI VE
* COLGATE PALMOLI VE









34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 38
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * C * *
* COLGATE PALMOLI VE
COLGATE TOTAL, SODI UM FLUORI DE ( OTC)
CONCORDI A PHARMS I NC
* CONCORDI A PHARMACEUTI CALS I NC
KAPVAY, CLONI DI NE HYDROCHLORI DE
ORAPRED ODT, PREDNI SOLONE SODI UM PHOSPHATE
ORAPRED, PREDNI SOLONE SODI UM PHOSPHATE
CONTRACT PHARMACAL
* CONTRACT PHARMACAL CORP
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CI METI DI NE, CI METI DI NE ( OTC)
FOLI C ACI D, FOLI C ACI D
I BUPROFEN AND PSEUDOEPHEDRI NE HYDROCHLORI DE, I BUPROFEN ( OTC)
I BUPROFEN, I BUPROFEN
I BUPROFEN, I BUPROFEN ( OTC)
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE ( OTC)
NAPROXEN SODI UM, NAPROXEN SODI UM ( OTC)
PREDNI SONE, PREDNI SONE
PROFEN, I BUPROFEN ( OTC)
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
CORCEPT THERAP
* CORCEPT THERAPEUTI CS I NC
KORLYM, MI FEPRI STONE
CORDEN PHARMA
* CORDEN PHARMA LATI NA SPA
CEENU, LOMUSTI NE
COREPHARMA
* COREPHARMA LLC
ALPRAZOLAM, ALPRAZOLAM
BENZTROPI NE MESYLATE, BENZTROPI NE MESYLATE
CLI NDAMYCI N HYDROCHLORI DE, CLI NDAMYCI N HYDROCHLORI DE
CYPROHEPTADI NE HYDROCHLORI DE, CYPROHEPTADI NE HYDROCHLORI DE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMI NE
DI ETHYLPROPI ON HYDROCHLORI DE, DI ETHYLPROPI ON HYDROCHLORI DE
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
GLI PI ZI DE AND METFORMI N HYDROCHLORI DE, GLI PI ZI DE
GLYBURI DE AND METFORMI N HYDROCHLORI DE, GLYBURI DE
GLYBURI DE, GLYBURI DE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
I SOSORBI DE DI NI TRATE, I SOSORBI DE DI NI TRATE
LEVOCARNI TI NE, LEVOCARNI TI NE
METHENAMI NE HI PPURATE, METHENAMI NE HI PPURATE
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
PI LOCARPI NE HYDROCHLORI DE, PI LOCARPI NE HYDROCHLORI DE
POTASSI UM CI TRATE, POTASSI UM CI TRATE
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
TRANDOLAPRI L, TRANDOLAPRI L
URSODI OL, URSODI OL
CORNERSTONE THERAP
* CORNERSTONE THERAPEUTI CS I NC
BETHKI S, TOBRAMYCI N
CUROSURF, PORACTANT ALFA
HYDROCODONE POLI STI REX AND CHLORPHENI RAMNE POLI STI REX, CHLORPHENI RAMI NE POLI STI REX
ZYFLO CR, ZI LEUTON
ZYFLO, ZI LEUTON
COVI DI EN
* COVI DI EN
LYMPHAZURI N, I SOSULFAN BLUE
COVI S PHARMA
* COVI S PHARMA SARL
FORTAZ I N PLASTI C CONTAI NER, CEFTAZI DI ME SODI UM
FORTAZ, CEFTAZI DI ME
LANOXI N PEDI ATRI C, DI GOXI N
LANOXI N, DI GOXI N
PARNATE, TRANYLCYPROMI NE SULFATE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 39
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * C * *
* COVI S PHARMA SARL
ZANTAC, RANI TI DI NE HYDROCHLORI DE
ZI NACEF I N PLASTI C CONTAI NER, CEFUROXI ME SODI UM
ZI NACEF, CEFUROXI ME SODI UM
COVI S PHARMA SARL
* COVI S PHARMA SARL
KAYEXALATE, SODI UM POLYSTYRENE SULFONATE
NI LANDRON, NI LUTAMI DE
RI LUTEK, RI LUZOLE
UROXATRAL, ALFUZOSI N HYDROCHLORI DE
CPPI CV
* CP PHARMACEUTI CALS I NTERNATI ONAL CV
SUTENT, SUNI TI NI B MALATE
CREALTA PHARMS LLC
* CREALTA PHARMACEUTI CALS LLC
MI GERGOT, CAFFEI NE
CROWN LABS
* CROWN LABORATORI ES I NC
ALA- CORT, HYDROCORTI SONE
ALA- SCALP, HYDROCORTI SONE
TRI DERM, TRI AMCI NOLONE ACETONI DE
CSL BEHRI NG
* CSL BEHRI NG LLC
STI MATE ( NEEDS NO REFRI GERATI ON) , DESMOPRESSI N ACETATE
CSPC OUYI PHARM CO
* CSPC OUYI PHARMACEUTI CAL CO LTD
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
CUBI ST
* CUBI ST PHARMACEUTI CALS I NC
CUBI CI N, DAPTOMYCI N
CUBI ST PHARMS
* CUBI ST PHARMACEUTI CALS I NC
ENTEREG, ALVI MOPAN
CUMBERLAND PHARMS
* CUMBERLAND PHARMACEUTI CALS I NC
ACETADOTE, ACETYLCYSTEI NE
CALDOLOR, I BUPROFEN
LACTULOSE, LACTULOSE
CYPRESS BI OSCI ENCE
* CYPRESS BI OSCI ENCE I NC
SAVELLA, MI LNACI PRAN HYDROCHLORI DE
CYPRESS PHARM
* CYPRESS PHARMACEUTI CAL I NC
CARBI NOXAMI NE MALEATE, CARBI NOXAMI NE MALEATE
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
ELI PHOS, CALCI UM ACETATE
REZI RA, HYDROCODONE BI TARTRATE
VI TUZ, CHLORPHENI RAMI NE MALEATE
ZUTRI PRO, CHLORPHENI RAMI NE MALEATE
* * D * *
DAI I CHI
* DAI I CHI PHARMACEUTI CAL CORP
FLOXI N OTI C, OFLOXACI N
DAI I CHI SANKYO
* DAI I CHI SANKYO I NC
AZOR, AMLODI PI NE BESYLATE
BENI CAR HCT, HYDROCHLOROTHI AZI DE
BENI CAR, OLMESARTAN MEDOXOMI L
EVOXAC, CEVI MELI NE HYDROCHLORI DE
TRI BENZOR, AMLODI PI NE BESYLATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 40
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * D * *
* DAI I CHI SANKYO I NC
WELCHOL, COLESEVELAM HYDROCHLORI DE
DANCO LABS LLC
* DANCO LABORATORI ES LLC
MI FEPREX, MI FEPRI STONE
DARA BI OSCI ENCES
* DARA BI OSCI ENCES I NC
SOLTAMOX, TAMOXI FEN CI TRATE
DAVA I NTL I NC
* DAVA I NTERNATI ONAL I NC
ALPRAZOLAM, ALPRAZOLAM
DAVA PHARMS I NC
* DAVA PHARMACEUTI CALS I NC
ACYCLOVI R, ACYCLOVI R
AMOXI CI LLI N, AMOXI CI LLI N
AMPI CI LLI N TRI HYDRATE, AMPI CI LLI N/ AMPI CI LLI N TRI HYDRATE
ATENOLOL, ATENOLOL
CI METI DI NE HYDROCHLORI DE, CI METI DI NE HYDROCHLORI DE
CI METI DI NE, CI METI DI NE
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
DI AZEPAM, DI AZEPAM
DOXAZOSI N MESYLATE, DOXAZOSI N MESYLATE
GEMFI BROZI L, GEMFI BROZI L
GLYBURI DE ( MI CRONI ZED) , GLYBURI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
METHOTREXATE SODI UM, METHOTREXATE SODI UM
NAPROXEN, NAPROXEN
PENI CI LLI N V POTASSI UM, PENI CI LLI N V POTASSI UM
PROPYLTHI OURACI L, PROPYLTHI OURACI L
PYRAZI NAMI DE, PYRAZI NAMI DE
SELEGI LI NE HYDROCHLORI DE, SELEGI LI NE HYDROCHLORI DE
VOSPI RE ER, ALBUTEROL SULFATE
DAVI S AND GECK
* DAVI S AND GECK DI V AMERI CAN CYANAMI D CO
PRE- OP I I , HEXACHLOROPHENE
PRE- OP, HEXACHLOROPHENE
DELCOR ASSET
* DELCOR ASSET CORP
EVOCLI N, CLI NDAMYCI N PHOSPHATE
LUXI Q, BETAMETHASONE VALERATE
OLUX E, CLOBETASOL PROPI ONATE
ZOVI RAX, ACYCLOVI R
DELCOR ASSET CORP
* DELCOR ASSET CORP
ERYGEL, ERYTHROMYCI N
DENCO ASSET
* DENCO ASSET LLC
DENAVI R, PENCI CLOVI R SODI UM
DENTSPLY PHARM
* DENTSPLY PHARMACEUTI CAL I NC
CI TANEST FORTE DENTAL, EPI NEPHRI NE BI TARTRATE
ORAQI X, LI DOCAI NE
DEPOMED I NC
* DEPOMED I NC
GRALI SE, GABAPENTI N
LAZANDA, FENTANYL CI TRATE
ZI PSOR, DI CLOFENAC POTASSI UM
DEPROCO
* DEPROCO I NC
LI GNOSPAN FORTE, EPI NEPHRI NE BI TARTRATE
LI GNOSPAN STANDARD, EPI NEPHRI NE BI TARTRATE
SCANDONEST L, LEVONORDEFRI N
SCANDONEST PLAI N, MEPI VACAI NE HYDROCHLORI DE
SEPTOCAI NE, ARTI CAI NE HYDROCHLORI DE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 41
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * D * *
DEXCEL LTD
* DEXCEL LTD
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
I SOSORBI DE MONONI TRATE, I SOSORBI DE MONONI TRATE
DEXCEL PHARMA
* DEXCEL PHARMA TECHNOLOGI ES LTD
OMEPRAZOLE, OMEPRAZOLE ( OTC)
PERI OCHI P, CHLORHEXI DI NE GLUCONATE
DEY
* DEY LP
ACCUNEB, ALBUTEROL SULFATE
CROMOLYN SODI UM, CROMOLYN SODI UM
DUONEB, ALBUTEROL SULFATE
I PRATROPI UM BROMI DE, I PRATROPI UM BROMI DE
LEVALBUTEROL HYDROCHLORI DE, LEVALBUTEROL HYDROCHLORI DE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
DI ALYSI S SUPS
* DI ALYSI S SUPPLI ES I NC
NORMOCARB HF 25, MAGNESI UM CHLORI DE
NORMOCARB HF 35, MAGNESI UM CHLORI DE
DI GESTI VE CARE I NC
* DI GESTI VE CARE I NC
PERTZYE, PANCRELI PASE ( AMYLASE
DI SCOVERY LABS
* DI SCOVERY LABORATORI ES I NC
SURFAXI N, LUCI NACTANT
DORADO PHARMA
* DORADO PHARMA LLC
KETOPROFEN, KETOPROFEN
DORC
* DORC I NTERNATI ONAL BV
MEMBRANEBLUE, TRYPAN BLUE
VI SI ONBLUE, TRYPAN BLUE
DOUGLAS PHARMS
* DOUGLAS PHARMACEUTI CALS AMERI CA LTD
MYORI SAN, I SOTRETI NOI N
DOW PHARM
* DOWPHARMACEUTI CAL SCI ENCES
ACANYA, BENZOYL PEROXI DE
AKNE- MYCI N, ERYTHROMYCI N
ATRALI N, TRETI NOI N
NUTRACORT, HYDROCORTI SONE
OXSORALEN- ULTRA, METHOXSALEN
DR REDDYS LA
* DR REDDYS LABORATORI ES LOUI SI ANA LLC
I BUPROFEN, I BUPROFEN
I BUPROFEN, I BUPROFEN ( OTC)
LOPURI N, ALLOPURI NOL
SSD AF, SI LVER SULFADI AZI NE
SSD, SI LVER SULFADI AZI NE
DR REDDYS LABS I NC
* DR REDDYS LABORATORI ES I NC
AMLODI PI NE BESYLATE AND BENAZEPRI L HYDROCHLORI DE, AMLODI PI NE BESYLATE
AMOXI L, AMOXI CI LLI N
AUGMENTI N ' 125' , AMOXI CI LLI N
AUGMENTI N ' 200' , AMOXI CI LLI N
AUGMENTI N ' 250' , AMOXI CI LLI N
AUGMENTI N ' 400' , AMOXI CI LLI N
AUGMENTI N ' 500' , AMOXI CI LLI N
AUGMENTI N ' 875' , AMOXI CI LLI N
AUGMENTI N ES- 600, AMOXI CI LLI N
AUGMENTI N XR, AMOXI CI LLI N
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
FI NASTERI DE, FI NASTERI DE












34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 42
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * D * *
* DR REDDYS LABORATORI ES I NC
FLUCONAZOLE, FLUCONAZOLE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
I BUPROFEN, I BUPROFEN
I BUPROFEN, I BUPROFEN ( OTC)
LAROTI D, AMOXI CI LLI N
LEVOFLOXACI N, LEVOFLOXACI N
MELOXI CAM, MELOXI CAM
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
NAPROXEN SODI UM AND PSEUDOEPHEDRI NE HYDROCHLORI DE, NAPROXEN SODI UM ( OTC)
NAPROXEN SODI UM, NAPROXEN SODI UM ( OTC)
NEFAZODONE HYDROCHLORI DE, NEFAZODONE HYDROCHLORI DE
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RI VASTI GMI NE TARTRATE, RI VASTI GMI NE TARTRATE
SI MVASTATI N, SI MVASTATI N
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
ZI PRASI DONE HYDROCHLORI DE, ZI PRASI DONE HYDROCHLORI DE
DR REDDYS LABS LTD
* DR REDDYS LABORATORI ES LI MI TED
LEVOCETI RI ZI NE DI HYDROCHLORI DE, LEVOCETI RI ZI NE DI HYDROCHLORI DE
* DR REDDYS LABORATORI ES LTD
ALENDRONATE SODI UM, ALENDRONATE SODI UM
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
ANASTROZOLE, ANASTROZOLE
ATORVASTATI N CALCI UM, ATORVASTATI N CALCI UM
AZACI TI DI NE, AZACI TI DI NE
BUSPI RONE HYDROCHLORI DE, BUSPI RONE HYDROCHLORI DE
CANDESARTAN CI LEXETI L AND HYDROCHLOROTHI AZI DE, CANDESARTAN CI LEXETI L
CARVEDI LOL, CARVEDI LOL
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CI PROFLOXACI N EXTENDED RELEASE, CI PROFLOXACI N
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
DECI TABI NE, DECI TABI NE
DESLORATADI NE AND PSEUDOEPHEDRI NE SULFATE 24 HOUR, DESLORATADI NE
DESLORATADI NE, DESLORATADI NE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DULOXETI NE HYDROCHLORI DE, DULOXETI NE HYDROCHLORI DE
ENALAPRI L MALEATE AND HYDROCHLOROTHI AZI DE, ENALAPRI L MALEATE
FAMOTI DI NE, FAMOTI DI NE
FAMOTI DI NE, FAMOTI DI NE ( OTC)
FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
FEXOFENADI NE HYDROCHLORI DE AND PSEUDOEPHEDRI NE HYDROCHLORI DE, FEXOFENADI NE
FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
FEXOFENADI NE HYDROCHLORI DE, FEXOFENADI NE HYDROCHLORI DE
FI NASTERI DE, FI NASTERI DE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FONDAPARI NUX SODI UM, FONDAPARI NUX SODI UM
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
GLI MEPI RI DE, GLI MEPI RI DE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
I BANDRONATE SODI UM, I BANDRONATE SODI UM
I BUPROFEN AND DI PHENHYDRAMI NE CI TRATE, DI PHENHYDRAMI NE CI TRATE ( OTC)
I BUPROFEN AND PSEUDOEPHEDRI NE HYDROCHLORI DE, I BUPROFEN ( OTC)
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 43
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * D * *
* DR REDDYS LABORATORI ES LTD
I RBESARTAN, I RBESARTAN
I RI NOTECAN HYDROCHLORI DE,
LAMOTRI GI NE, LAMOTRI GI NE
I RI NOTECAN HYDROCHLORI DE
LANSOPRAZOLE, LANSOPRAZOLE
LANSOPRAZOLE, LANSOPRAZOLE ( OTC)
LATANOPROST, LATANOPROST
LETROZOLE, LETROZOLE
LEVETI RACETAM, LEVETI RACETAM
METOPROLOL SUCCI NATE, METOPROLOL SUCCI NATE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
MONTELUKAST SODI UM, MONTELUKAST SODI UM
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
NAPROXEN AND ESOMEPRAZOLE MAGNESI UM, ESOMEPRAZOLE MAGNESI UM
NAPROXEN SODI UM, NAPROXEN SODI UM
NATEGLI NI DE, NATEGLI NI DE
NI ZATI DI NE, NI ZATI DI NE
OFLOXACI N, OFLOXACI N
OLANZAPI NE, OLANZAPI NE
OMEPRAZOLE MAGNESI UM, OMEPRAZOLE MAGNESI UM ( OTC)
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
OXAPROZI N, OXAPROZI N
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
RABEPRAZOLE SODI UM, RABEPRAZOLE SODI UM
RAMI PRI L, RAMI PRI L
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
RI SPERI DONE, RI SPERI DONE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
SI LDENAFI L CI TRATE, SI LDENAFI L CI TRATE
TACROLI MUS, TACROLI MUS
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
VI NORELBI NE TARTRATE, VI NORELBI NE TARTRATE
ZAFI RLUKAST, ZAFI RLUKAST
ZENATANE, I SOTRETI NOI N
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
DR REDDYS LABS SA
* DR REDDYS LABORATORI ES SA
FENOFI BRATE ( MI CRONI ZED) , FENOFI BRATE
DRAXI MAGE
* DRAXI MAGE I NC
DTPA, TECHNETI UM TC- 99M PENTETATE KI T
TECHNETI UM TC 99M ALBUMI N AGGREGATED KI T, TECHNETI UM TC- 99M ALBUMI N AGGREGATED KI T
TECHNETI UM TC 99M SESTAMI BI , TECHNETI UM TC- 99M SESTAMI BI KI T
DSM PHARMS I NC
* DSM PHARMACEUTI CALS I NC
GRANI SETRON HYDROCHLORI DE PRESERVATI VE FREE, GRANI SETRON HYDROCHLORI DE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
DUCHESNAY
* DUCHESNAY I NC
DI CLEGI S, DOXYLAMI NE SUCCI NATE
DURAMED PHARMS BARR
* DURAMED PHARMACEUTI CALS I NC SUB BARR LABORATORI ES I NC
AVI ANE- 28, ETHI NYL ESTRADI OL
CRYSELLE, ETHI NYL ESTRADI OL
DESOGESTREL AND ETHI NYL ESTRADI OL, DESOGESTREL
DI AMOX, ACETAZOLAMI DE
ENPRESSE- 28, ETHI NYL ESTRADI OL
METHYLPREDNI SOLONE, METHYLPREDNI SOLONE
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 44
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * D * *
* DURAMED PHARMACEUTI CALS I NC SUB BARR LABORATORI ES I NC
TRI AMTERENE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
VELI VET, DESOGESTREL
DURAMED RES
* DURAMED RESEARCH I NC
AYGESTI N, NORETHI NDRONE ACETATE
DUSA
* DUSA PHARMACEUTI CALS I NC
LEVULAN, AMI NOLEVULI NI C ACI D HYDROCHLORI DE
REDDYS
* DOCTOR REDDYS LABORATORI ES LTD
DESLORATADI NE, DESLORATADI NE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
METOPROLOL SUCCI NATE, METOPROLOL SUCCI NATE
* * E * *
EAGLE PHARMS
* EAGLE PHARMACEUTI CALS I NC
ARGATROBAN I N SODI UM CHLORI DE, ARGATROBAN
EASTMAN KODAK
* EASTMAN KODAK CO
LI DOCAI NE HYDROCHLORI DE AND EPI NEPHRI NE, EPI NEPHRI NE
EBEWE PHARMA
* EBEWE PHARMA
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
* EBEWE PHARMA GES MBH NFG KG
CARBOPLATI N, CARBOPLATI N
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
FLUOROURACI L, FLUOROURACI L
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
METHOTREXATE SODI UM PRESERVATI VE FREE, METHOTREXATE SODI UM
OXALI PLATI N, OXALI PLATI N
PACLI TAXEL, PACLI TAXEL
VI NORELBI NE TARTRATE, VI NORELBI NE TARTRATE
ECLAT PHARMS LLC
* ECLAT PHARMACEUTI CALS LLC
BLOXI VERZ, NEOSTI GMI NE METHYLSULFATE
ECOLAB
* ECOLAB I NC
CHG SCRUB, CHLORHEXI DI NE GLUCONATE ( OTC)
CI DA- STAT, CHLORHEXI DI NE GLUCONATE ( OTC)
ECR
* ECR PHARMACEUTI CALS
DEXAMETHASONE, DEXAMETHASONE
EDGEMONT PHARMS LLC
* EDGEMONT PHARMACEUTI CALS LLC
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FORFI VO XL, BUPROPI ON HYDROCHLORI DE
EI I NC
* EI I NC
THEROXI DI L, MI NOXI DI L ( OTC)
EI SAI I NC
* EI SAI I NC
ACI PHEX SPRI NKLE, RABEPRAZOLE SODI UM
ACI PHEX, RABEPRAZOLE SODI UM
ARI CEPT ODT, DONEPEZI L HYDROCHLORI DE
ARI CEPT, DONEPEZI L HYDROCHLORI DE
BANZEL, RUFI NAMI DE
BELVI Q, LORCASERI N HYDROCHLORI DE
DACOGEN, DECI TABI NE
FRAGMI N, DALTEPARI N SODI UM
FYCOMPA, PERAMPANEL
HALAVEN, ERI BULI N MESYLATE
HEXALEN, ALTRETAMI NE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 45
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * E * *
* EI SAI I NC
PANRETI N, ALI TRETI NOI N
SALAGEN, PI LOCARPI NE HYDROCHLORI DE
ZONEGRAN, ZONI SAMI DE
EKR THERAP
* EKR THERAPEUTI CS I NC
CARDENE I N 0. 83%SODI UM CHLORI DE I N PLASTI C CONTAI NER, NI CARDI PI NE HYDROCHLORI DE
CARDENE I N 0. 86%SODI UM CHLORI DE I N PLASTI C CONTAI NER, NI CARDI PI NE HYDROCHLORI DE
CARDENE I N 4. 8%DEXTROSE I N PLASTI C CONTAI NER, NI CARDI PI NE HYDROCHLORI DE
CARDENE I N 5. 0%DEXTROSE I N PLASTI C CONTAI NER, NI CARDI PI NE HYDROCHLORI DE
CARDENE SR, NI CARDI PI NE HYDROCHLORI DE
CARDENE, NI CARDI PI NE HYDROCHLORI DE
ELI LI LLY AND CO
* ELI LI LLY AND CO
AXI RON, TESTOSTERONE
EFFI ENT, PRASUGREL HYDROCHLORI DE
PROZAC, FLUOXETI NE HYDROCHLORI DE
SARAFEM, FLUOXETI NE HYDROCHLORI DE
ELI LI LLY CO
* ELI LI LLY CO
ADCI RCA, TADALAFI L
ZYPREXA RELPREVV, OLANZAPI NE PAMOATE
ELI TE LABS
* ELI TE LABORATORI ES I NC
HYDROMORPHONE HYDROCHLORI DE, HYDROMORPHONE HYDROCHLORI DE
NALTREXONE HYDROCHLORI DE, NALTREXONE HYDROCHLORI DE
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
EMCURE PHARMS
* EMCURE PHARMACEUTI CALS LTD
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
EMCURE PHARMS I NDI A
* EMCURE PHARMACEUTI CALS LTD I NDI A
FOSI NOPRI L SODI UM AND HYDROCHLOROTHI AZI DE, FOSI NOPRI L
EMCURE PHARMS LTD
* EMCURE PHARMACEUTI CALS LTD
ACARBOSE, ACARBOSE
AMI KACI N SULFATE, AMI KACI N SULFATE
BENZPHETAMI NE HYDROCHLORI DE, BENZPHETAMI NE HYDROCHLORI DE
BI CNU, CARMUSTI NE
CI DOFOVI R, CI DOFOVI R
COLI STI METHATE SODI UM, COLI STI METHATE SODI UM
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
LEVOFLOXACI N, LEVOFLOXACI N
METOCLOPRAMI DE, METOCLOPRAMI DE HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
PROCHLORPERAZI NE EDI SYLATE, PROCHLORPERAZI NE EDI SYLATE
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
EMCURE PHARMS USA
* EMCURE PHARMACEUTI CALS USA I NC
DI FLUNI SAL, DI FLUNI SAL
HYDROXYZI NE PAMOATE, HYDROXYZI NE PAMOATE
METHI MAZOLE, METHI MAZOLE
NI FEDI PI NE, NI FEDI PI NE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 ( OTC)
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
EMCURE USA
* EMCURE PHARMACEUTI CALS USA I NC
BETHANECHOL CHLORI DE, BETHANECHOL CHLORI DE
EMD SERONO
* EMD SERONO I NC
EGRI FTA, TESAMORELI N ACETATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 46
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * E * *
* EMD SERONO I NC
GONAL- F RFF PEN, FOLLI TROPI N ALFA/ BETA
GONAL- F RFF, FOLLI TROPI N ALFA/ BETA
GONAL- F, FOLLI TROPI N ALFA/ BETA
OVI DREL, CHORI OGONADOTROPI N ALFA
SAI ZEN, SOMATROPI N RECOMBI NANT
SEROPHENE, CLOMI PHENE CI TRATE
SEROSTI M, SOMATROPI N RECOMBI NANT
ZORBTI VE, SOMATROPI N RECOMBI NANT
EMD SERONO I NC
* EMD SERONO I NC
CETROTI DE, CETRORELI X
EMMAUS MEDCL
* EMMAUS MEDI CAL I NC
NUTRESTORE, GLUTAMI NE
ENDO PHARM
* ENDO PHARMACEUTI CAL SOLUTI ONS I NC
SUPPRELI N LA, HI STRELI N ACETATE
VALSTAR PRESERVATI VE FREE, VALRUBI CI N
VANTAS, HI STRELI N ACETATE
ENDO PHARMS
* ENDO PHARMACEUTI CALS I NC
DELATESTRYL, TESTOSTERONE ENANTHATE
FORTESTA, TESTOSTERONE
FROVA, FROVATRI PTAN SUCCI NATE
OPANA ER, OXYMORPHONE HYDROCHLORI DE
OPANA, OXYMORPHONE HYDROCHLORI DE
PERCODAN, ASPI RI N
EPI C PHARMA
* EPI C PHARMA I NC
MEPERI DI NE HYDROCHLORI DE, MEPERI DI NE HYDROCHLORI DE
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
* EPI C PHARMA LLC
BETAXOLOL HYDROCHLORI DE, BETAXOLOL HYDROCHLORI DE
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
FLAVOXATE HYDROCHLORI DE, FLAVOXATE HYDROCHLORI DE
SULI NDAC, SULI NDAC
TRANDOLAPRI L, TRANDOLAPRI L
URSODI OL, URSODI OL
EPI C PHARMA I NC
* EPI C PHARMA I NC
SOTALOL HYDROCHLORI DE, SOTALOL HYDROCHLORI DE
EPI C PHARMA LLC
* EPI C PHARMA LLC
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
GUANFACI NE HYDROCHLORI DE, GUANFACI NE HYDROCHLORI DE
MECLI ZI NE HYDROCHLORI DE, MECLI ZI NE HYDROCHLORI DE
PROTRI PTYLI NE HYDROCHLORI DE, PROTRI PTYLI NE HYDROCHLORI DE
ERGOJ ECT
* ERGOJ ECT LLC
METHYLERGONOVI NE MALEATE, METHYLERGONOVI NE MALEATE
ETHYPHARM
* ETHYPHARM
BUPRENORPHI NE HYDROCHLORI DE, BUPRENORPHI NE HYDROCHLORI DE
EURAND
* EURAND AMERI CA I NC
POTASSI UM CHLORI DE, POTASSI UM CHLORI DE
EXALENZ BI OSCI ENCE
* EXALENZ BI OSCI ENCE LTD
I DKI T: HP, CI TRI C ACI D
EXCELLI UM
* EXCELLI UM PHARMACEUTI CAL I NC
BENZTROPI NE MESYLATE, BENZTROPI NE MESYLATE
FOLI C ACI D, FOLI C ACI D





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 47
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * E * *
* EXCELLI UM PHARMACEUTI CAL I NC
FUROSEMI DE, FUROSEMI DE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I MI PRAMI NE HYDROCHLORI DE, I MI PRAMI NE HYDROCHLORI DE
LORAZEPAM, LORAZEPAM
EXELA PHARMA SCI ENCE
* EXELA PHARMA SCI ENCES
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
EXELA PHARMA SCS LLC
* EXELA PHARMA SCI ENCES LLC
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
EXELI XI S
* EXELI XI S I NC
COMETRI Q, CABOZANTI NI B S- MALATE
FOUGERA
* E FOUGERA DI V ALTANA I NC
BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
FLUOCI NOLONE ACETONI DE, FLUOCI NOLONE ACETONI DE
FLUOCI NONI DE, FLUOCI NONI DE
GENTAMI CI N SULFATE, GENTAMI CI N SULFATE
HYDROCORTI SONE, HYDROCORTI SONE
LI DOCAI NE, LI DOCAI NE
NI TROGLYCERI N, NI TROGLYCERI N
NYSTATI N AND TRI AMCI NOLONE ACETONI DE, NYSTATI N
NYSTATI N, NYSTATI N
LI LLY
* ELI LI LLY AND CO
ALI MTA, PEMETREXED DI SODI UM
CI ALI S, TADALAFI L
CYMBALTA, DULOXETI NE HYDROCHLORI DE
EVI STA, RALOXI FENE HYDROCHLORI DE
FORTEO, TERI PARATI DE RECOMBI NANT HUMAN
GEMZAR, GEMCI TABI NE HYDROCHLORI DE
GLUCAGON, GLUCAGON RECOMBI NANT
HUMALOG KWI KPEN, I NSULI N LI SPRO RECOMBI NANT
HUMALOG MI X 50/ 50 KWI KPEN, I NSULI N LI SPRO PROTAMI NE RECOMBI NANT
HUMALOG MI X 50/ 50, I NSULI N LI SPRO PROTAMI NE RECOMBI NANT
HUMALOG MI X 75/ 25 KWI KPEN, I NSULI N LI SPRO PROTAMI NE RECOMBI NANT
HUMALOG MI X 75/ 25, I NSULI N LI SPRO PROTAMI NE RECOMBI NANT
HUMALOG, I NSULI N LI SPRO RECOMBI NANT
HUMATROPE, SOMATROPI N RECOMBI NANT
HUMULI N 70/ 30 PEN, I NSULI N RECOMBI NANT HUMAN ( OTC)
HUMULI N 70/ 30, I NSULI N RECOMBI NANT HUMAN ( OTC)
HUMULI N N, I NSULI N SUSP I SOPHANE RECOMBI NANT HUMAN ( OTC)
HUMULI N R PEN, I NSULI N RECOMBI NANT HUMAN ( OTC)
HUMULI N R, I NSULI N RECOMBI NANT HUMAN
HUMULI N R, I NSULI N RECOMBI NANT HUMAN ( OTC)
PROZAC WEEKLY, FLUOXETI NE HYDROCHLORI DE
QUI NI DI NE GLUCONATE, QUI NI DI NE GLUCONATE
STRATTERA, ATOMOXETI NE HYDROCHLORI DE
SYMBYAX, FLUOXETI NE HYDROCHLORI DE
ZYPREXA ZYDI S, OLANZAPI NE
ZYPREXA, OLANZAPI NE
* * F * *
FACTA FARMA
* FACTA FARMACEUTI CI SPA
CEPHALEXI N, CEPHALEXI N
FALCON PHARMS
* FALCON PHARMACEUTI CALS I NC
TI MOLOL MALEATE, TI MOLOL MALEATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 48
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * F * *
* FALCON PHARMACEUTI CALS LTD
DI PI VEFRI N HYDROCHLORI DE, DI PI VEFRI N HYDROCHLORI DE
GENTAMI CI N SULFATE, GENTAMI CI N SULFATE
LEVOBUNOLOL HYDROCHLORI DE, LEVOBUNOLOL HYDROCHLORI DE
MAXI TROL, DEXAMETHASONE
METI PRANOLOL, METI PRANOLOL HYDROCHLORI DE
TI MOLOL MALEATE, TI MOLOL MALEATE
TOBREX, TOBRAMYCI N
TRI METHOPRI M SULFATE AND POLYMYXI N B SULFATE, POLYMYXI N B SULFATE
FAMY CARE LTD
* FAMY CARE LTD
DESOGESTREL AND ETHI NYL ESTRADI OL, DESOGESTREL
LEVONORGESTREL AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
NORETHI NDRONE ACETATE AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
NORETHI NDRONE AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
NORETHI NDRONE, NORETHI NDRONE
FDC LTD
* FDC LTD
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
OFLOXACI N, OFLOXACI N
TI MOLOL MALEATE, TI MOLOL MALEATE
FEI NSTEI N
* FEI NSTEI N I NSTI TUTE MEDI CAL RESEARCH
AMMONI A N 13, AMMONI A N- 13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F- 18
FERA PHARMS
* FERA PHARMACEUTI CALS LLC
OFLOXACI N, OFLOXACI N
TOBRAMYCI N, TOBRAMYCI N
FERNDALE LABS
* FERNDALE LABORATORI ES I NC
HYDROCORTI SONE ACETATE, HYDROCORTI SONE ACETATE
FERRI NG
* FERRI NG PHARMACEUTI CALS I NC
ACTHREL, CORTI CORELI N OVI NE TRI FLUTATE
BRAVELLE, UROFOLLI TROPI N
CHORI ONI C GONADOTROPI N, GONADOTROPI N, CHORI ONI C
DESMOPRESSI N ACETATE, DESMOPRESSI N ACETATE
ENDOMETRI N, PROGESTERONE
FI RMAGON, DEGARELI X ACETATE
MENOPUR, MENOTROPI NS ( FSH
MI NI RI N, DESMOPRESSI N ACETATE
REPRONEX, MENOTROPI NS ( FSH
TEV- TROPI N, SOMATROPI N RECOMBI NANT
FERRI NG CONTROLLED
* FERRI NG CONTROLLED THERAPEUTI CS LTD
CERVI DI L, DI NOPROSTONE
FERRI NG PHARMS AS
* FERRI NG PHARMACEUTI CALS AS
LYSTEDA, TRANEXAMI C ACI D
PREPOPI K, CI TRI C ACI D
FOREST LABS
* FOREST LABORATORI ES I NC
BYSTOLI C, NEBI VOLOL HYDROCHLORI DE
CAMPRAL, ACAMPROSATE CALCI UM
CELEXA, CI TALOPRAM HYDROBROMI DE
LEXAPRO, ESCI TALOPRAM OXALATE
NAMENDA XR, MEMANTI NE HYDROCHLORI DE
NAMENDA, MEMANTI NE HYDROCHLORI DE
THYROLAR- 0. 25, LI OTRI X ( T4
THYROLAR- 0. 5, LI OTRI X ( T4
THYROLAR- 1, LI OTRI X ( T4
THYROLAR- 2, LI OTRI X ( T4
THYROLAR- 3, LI OTRI X ( T4
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 49
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * F * *
FOREST LABS I NC
* FOREST LABORATORI ES I NC
FETZI MA, LEVOMI LNACI PRAN HYDROCHLORI DE
LI NZESS, LI NACLOTI DE
TUDORZA PRESSAI R, ACLI DI NI UM BROMI DE
VI I BRYD, VI LAZODONE HYDROCHLORI DE
FOREST RES I NST I NC
* FOREST RESEARCH I NSTI TUTE I NC
DALI RESP, ROFLUMI LAST
FOUGERA PHARMS
* FOUGERA PHARMACEUTI CALS I NC
ACLOVATE, ALCLOMETASONE DI PROPI ONATE
ADAPALENE, ADAPALENE
ALCLOMETASONE DI PROPI ONATE, ALCLOMETASONE DI PROPI ONATE
AMCI NONI DE, AMCI NONI DE
BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
C- SOLVE- 2, ERYTHROMYCI N
CALCI POTRI ENE, CALCI POTRI ENE
CI CLOPI ROX, CI CLOPI ROX
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
CLOBETASOL PROPI ONATE ( EMOLLI ENT) , CLOBETASOL PROPI ONATE
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
CLOTRI MAZOLE AND BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
CLOTRI MAZOLE, CLOTRI MAZOLE
CUTI VATE, FLUTI CASONE PROPI ONATE
DESONI DE, DESONI DE
DESOXI METASONE, DESOXI METASONE
DI FLORASONE DI ACETATE, DI FLORASONE DI ACETATE
ECONAZOLE NI TRATE, ECONAZOLE NI TRATE
ERYTHROMYCI N, ERYTHROMYCI N
FLUOCI NONI DE EMULSI FI ED BASE, FLUOCI NONI DE
FLUOCI NONI DE, FLUOCI NONI DE
FLUTI CASONE PROPI ONATE, FLUTI CASONE PROPI ONATE
HALOBETASOL PROPI ONATE, HALOBETASOL PROPI ONATE
HYDROCORTI SONE, HYDROCORTI SONE
I MI QUI MOD, I MI QUI MOD
KETOCONAZOLE, KETOCONAZOLE
LI DOCAI NE AND PRI LOCAI NE, LI DOCAI NE
METRONI DAZOLE, METRONI DAZOLE
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPI ROCI N, MUPI ROCI N
NYSTATI N, NYSTATI N
OXI STAT, OXI CONAZOLE NI TRATE
PAMI NE FORTE, METHSCOPOLAMI NE BROMI DE
PAMI NE, METHSCOPOLAMI NE BROMI DE
PANDEL, HYDROCORTI SONE PROBUTATE
PREDNI CARBATE, PREDNI CARBATE
SOLARAZE, DI CLOFENAC SODI UM
SULFACETAMI DE SODI UM, SULFACETAMI DE SODI UM
TEMOVATE E, CLOBETASOL PROPI ONATE
TEMOVATE, CLOBETASOL PROPI ONATE
TERCONAZOLE, TERCONAZOLE
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
TYZI NE, TETRAHYDROZOLI NE HYDROCHLORI DE
ZONALON, DOXEPI N HYDROCHLORI DE
FRESENI US
* FRESENI US KABI DEUTSCHLAND GMBH
I NTRALI PI D 10%, SOYBEAN OI L
I NTRALI PI D 20%, SOYBEAN OI L
I NTRALI PI D 30%, SOYBEAN OI L
FRESENI US KABI
* FRESENI US KABI AUSTRI A GMBH
LACTULOSE, LACTULOSE
FRESENI US KABI ONCOL
* FRESENI US KABI ONCOLOGY PLC
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 50
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * F * *
* FRESENI US KABI ONCOLOGY PLC
ANASTROZOLE, ANASTROZOLE
BI CALUTAMI DE, BI CALUTAMI DE
CARBOPLATI N, CARBOPLATI N
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
LETROZOLE, LETROZOLE
OXALI PLATI N, OXALI PLATI N
PACLI TAXEL, PACLI TAXEL
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
FRESENI US KABI USA
* FRESENI US KABI USA LLC
ACYCLOVI R SODI UM, ACYCLOVI R SODI UM
ADENOSI NE, ADENOSI NE
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
ASTRAMORPH PF, MORPHI NE SULFATE
AZI THROMYCI N, AZI THROMYCI N
AZTREONAM, AZTREONAM
BACI TRACI N, BACI TRACI N
BACTERI OSTATI C SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
BENZTROPI NE MESYLATE, BENZTROPI NE MESYLATE
BLEOMYCI N SULFATE, BLEOMYCI N SULFATE
CAFFEI NE CI TRATE, CAFFEI NE CI TRATE
CALCI TRI OL, CALCI TRI OL
CARBOPLATI N, CARBOPLATI N
CEFOTETAN, CEFOTETAN DI SODI UM
CEFTRI AXONE, CEFTRI AXONE SODI UM
CHLORAMPHENI COL SODI UM SUCCI NATE, CHLORAMPHENI COL SODI UM SUCCI NATE
CHLOROTHI AZI DE SODI UM, CHLOROTHI AZI DE SODI UM
CHORI ONI C GONADOTROPI N, GONADOTROPI N, CHORI ONI C
CI SPLATI N, CI SPLATI N
CLADRI BI NE, CLADRI BI NE
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
COLI STI METHATE SODI UM, COLI STI METHATE SODI UM
CYTARABI NE, CYTARABI NE
DACARBAZI NE, DACARBAZI NE
DAUNORUBI CI N HYDROCHLORI DE, DAUNORUBI CI N HYDROCHLORI DE
DEFEROXAMI NE MESYLATE, DEFEROXAMI NE MESYLATE
DEXAMETHASONE SODI UM PHOSPHATE, DEXAMETHASONE SODI UM PHOSPHATE
DI MENHYDRI NATE, DI MENHYDRI NATE
DI PRI VAN, PROPOFOL
DI PYRI DAMOLE, DI PYRI DAMOLE
DOXORUBI CI N HYDROCHLORI DE, DOXORUBI CI N HYDROCHLORI DE
DOXY 100, DOXYCYCLI NE HYCLATE
DOXY 200, DOXYCYCLI NE HYCLATE
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
ESMOLOL HYDROCHLORI DE, ESMOLOL HYDROCHLORI DE
ETOPOSI DE, ETOPOSI DE
FAMOTI DI NE PRESERVATI VE FREE, FAMOTI DI NE
FAMOTI DI NE, FAMOTI DI NE
FLOXURI DI NE, FLOXURI DI NE
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%, FLUCONAZOLE
FLUDARABI NE PHOSPHATE, FLUDARABI NE PHOSPHATE
FLUMAZENI L, FLUMAZENI L
FLUOROURACI L, FLUOROURACI L
FLUPHENAZI NE DECANOATE, FLUPHENAZI NE DECANOATE
FLUPHENAZI NE HYDROCHLORI DE, FLUPHENAZI NE HYDROCHLORI DE
FOLI C ACI D, FOLI C ACI D
FOSPHENYTOI N SODI UM, FOSPHENYTOI N SODI UM
FUROSEMI DE, FUROSEMI DE
GANCI CLOVI R, GANCI CLOVI R SODI UM
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
GENTAMI CI N SULFATE, GENTAMI CI N SULFATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 51
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * F * *
* FRESENI US KABI USA LLC
GRANI SETRON HYDROCHLORI DE PRESERVATI VE FREE, GRANI SETRON HYDROCHLORI DE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
HALOPERI DOL DECANOATE, HALOPERI DOL DECANOATE
HALOPERI DOL, HALOPERI DOL LACTATE
HEPARI N SODI UM I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM PRESERVATI VE FREE, HEPARI N SODI UM
HEPARI N SODI UM, HEPARI N SODI UM
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
I DARUBI CI N HYDROCHLORI DE, I DARUBI CI N HYDROCHLORI DE
I FOSFAMI DE, I FOSFAMI DE
I NDOMETHACI N, I NDOMETHACI N
I OPAMI DOL- 250, I OPAMI DOL
I OPAMI DOL- 300, I OPAMI DOL
I OPAMI DOL- 370, I OPAMI DOL
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
KANAMYCI N SULFATE, KANAMYCI N SULFATE
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
LEUCOVORI N CALCI UM PRESERVATI VE FREE, LEUCOVORI N CALCI UM
LEVETI RACETAM, LEVETI RACETAM
LEVOFLOXACI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, LEVOFLOXACI N
LEVOTHYROXI NE SODI UM, LEVOTHYROXI NE SODI UM
LI DOCAI NE HYDROCHLORI DE I N PLASTI C CONTAI NER, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE PRESERVATI VE FREE, LI DOCAI NE HYDROCHLORI DE
MAGNESI UM SULFATE, MAGNESI UM SULFATE
MANNI TOL 25%, MANNI TOL
MESNA, MESNA
METARAMI NOL BI TARTRATE, METARAMI NOL BI TARTRATE
METHOTREXATE PRESERVATI VE FREE, METHOTREXATE SODI UM
METHOTREXATE SODI UM, METHOTREXATE SODI UM
METHYLPREDNI SOLONE SODI UM SUCCI NATE, METHYLPREDNI SOLONE SODI UM SUCCI NATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
MI LRI NONE LACTATE, MI LRI NONE LACTATE
MI TOXANTRONE HYDROCHLORI DE, MI TOXANTRONE HYDROCHLORI DE
NAROPI N, ROPI VACAI NE HYDROCHLORI DE
NEBUPENT, PENTAMI DI NE I SETHI ONATE
NESACAI NE, CHLOROPROCAI NE HYDROCHLORI DE
NESACAI NE- MPF, CHLOROPROCAI NE HYDROCHLORI DE
OCTREOTI DE ACETATE ( PRESERVATI VE FREE) , OCTREOTI DE ACETATE
OCTREOTI DE ACETATE, OCTREOTI DE ACETATE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
OXALI PLATI N, OXALI PLATI N
OXYTOCI N, OXYTOCI N
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
PENTAM, PENTAMI DI NE I SETHI ONATE
POLOCAI NE, MEPI VACAI NE HYDROCHLORI DE
POLOCAI NE- MPF, MEPI VACAI NE HYDROCHLORI DE
POLYMYXI N B SULFATE, POLYMYXI N B SULFATE
POTASSI UM CHLORI DE I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE, POTASSI UM CHLORI DE
PROGESTERONE, PROGESTERONE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
PROTAMI NE SULFATE, PROTAMI NE SULFATE
PYRI DOXI NE HYDROCHLORI DE, PYRI DOXI NE HYDROCHLORI DE
ROCURONI UM BROMI DE, ROCURONI UM BROMI DE
SENSORCAI NE, BUPI VACAI NE HYDROCHLORI DE
SENSORCAI NE, BUPI VACAI NE HYDROCHLORI DE
SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
STERI LE WATER FOR I NJ ECTI ON I N PLASTI C CONTAI NER, STERI LE WATER FOR I NJ ECTI ON
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TERBUTALI NE SULFATE, TERBUTALI NE SULFATE
THI AMI NE HYDROCHLORI DE, THI AMI NE HYDROCHLORI DE




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 52
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * F * *
* FRESENI US KABI USA LLC
TOBRAMYCI N SULFATE ( PHARMACY BULK) , TOBRAMYCI N SULFATE
TOBRAMYCI N SULFATE, TOBRAMYCI N SULFATE
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
TRANEXAMI C ACI D, TRANEXAMI C ACI D
VALPROATE SODI UM, VALPROATE SODI UM
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
VI BI SONE, CYANOCOBALAMI N
VI NBLASTI NE SULFATE, VI NBLASTI NE SULFATE
VI NORELBI NE TARTRATE, VI NORELBI NE TARTRATE
XYLOCAI NE 4%PRESERVATI VE FREE, LI DOCAI NE HYDROCHLORI DE
XYLOCAI NE PRESERVATI VE FREE, LI DOCAI NE HYDROCHLORI DE
XYLOCAI NE VI SCOUS, LI DOCAI NE HYDROCHLORI DE
XYLOCAI NE W/ EPI NEPHRI NE, EPI NEPHRI NE
XYLOCAI NE, LI DOCAI NE HYDROCHLORI DE
FRESENI US MEDCL
* FRESENI US MEDI CAL CARE NORTH AMERI CA
CALCI TRI OL, CALCI TRI OL
DELFLEX W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 1. 5%LOWMAGNESI UM I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 1. 5%LOWMAGNESI UM LOWCALCI UM I N PLASTI C CONTAI NER, CALCI UM
DELFLEX W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 2. 5%LOWMAGNESI UM I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 2. 5%LOWMAGNESI UM LOWCALCI UM I N PLASTI C CONTAI NER, CALCI UM
DELFLEX W/ DEXTROSE 3. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 4. 25%LOWMAGNESI UM I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX W/ DEXTROSE 4. 25%LOWMAGNESI UM LOWCALCI UM I N PLASTI C CONTAI NER, CALCI UM
DELFLEX- LM W/ DEXTROSE 1. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX- LM W/ DEXTROSE 2. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX- LM W/ DEXTROSE 3. 5%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DELFLEX- LM W/ DEXTROSE 4. 25%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PHOSLO GELCAPS, CALCI UM ACETATE
PHOSLYRA, CALCI UM ACETATE
SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
FSC
* FSC LABORATORI ES I NC
PRI MSOL, TRI METHOPRI M HYDROCHLORI DE
* * G * *
G AND W LABS
* G AND WLABORATORI ES I NC
ACEPHEN, ACETAMI NOPHEN ( OTC)
CI CLOPI ROX, CI CLOPI ROX
FLUOCI NOLONE ACETONI DE, FLUOCI NOLONE ACETONI DE
FLUTI CASONE PROPI ONATE, FLUTI CASONE PROPI ONATE
HALOBETASOL PROPI ONATE, HALOBETASOL PROPI ONATE
I NDOMETHACI N, I NDOMETHACI N
METRONI DAZOLE, METRONI DAZOLE
MI CONAZOLE 7 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MI CONAZOLE NI TRATE, MI CONAZOLE NI TRATE ( OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
PROCHLORPERAZI NE, PROCHLORPERAZI NE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
PROMETHEGAN, PROMETHAZI NE HYDROCHLORI DE
G AND W LABS I NC
* G AND WLABORATORI ES I NC
CALCI POTRI ENE, CALCI POTRI ENE
CI CLOPI ROX, CI CLOPI ROX
FLUOCI NONI DE, FLUOCI NONI DE
METRONI DAZOLE, METRONI DAZOLE
MI CONAZOLE NI TRATE, MI CONAZOLE NI TRATE ( OTC)
GALDERMA LABS
* GALDERMA LABORATORI ES I NC
CLOBEX, CLOBETASOL PROPI ONATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 53
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * G * *
GALDERMA LABS LP
* GALDERMA LABORATORI ES L P
CLOBEX, CLOBETASOL PROPI ONATE
* GALDERMA LABORATORI ES LP
CAPEX, FLUOCI NOLONE ACETONI DE
CLOBEX, CLOBETASOL PROPI ONATE
DESOWEN, DESONI DE
DI FFERI N, ADAPALENE
EPI DUO, ADAPALENE
METROCREAM, METRONI DAZOLE
METROGEL, METRONI DAZOLE
METROLOTI ON, METRONI DAZOLE
MI RVASO, BRI MONI DI NE TARTRATE
ORACEA, DOXYCYCLI NE
PERI OSTAT, DOXYCYCLI NE HYCLATE
PLI AGLI S, LI DOCAI NE
TRI - LUMA, FLUOCI NOLONE ACETONI DE
VECTI CAL, CALCI TRI OL
GALEN ( UK)
* GALEN LTD
DAUNOXOME, DAUNORUBI CI N CI TRATE
GALEN SPECI ALTY
* GALEN SPECI ALTY PHARMA US LLC
SYNERA, LI DOCAI NE
GALENA BI OPHARMA
* GALENA BI OPHARMA
ABSTRAL, FENTANYL CI TRATE
GAMBRO RENAL PRODS
* GAMBRO RENAL PRODUCTS
PRI SMASOL B22GK 2/ 0 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL B22GK 4/ 0 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL B22GK 4/ 2. 5 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BGK 0/ 2. 5 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BGK 2/ 0 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BGK 2/ 3. 5 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BGK 4/ 0/ 1. 2 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BGK 4/ 2. 5 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BK 0/ 0/ 1. 2 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
PRI SMASOL BK 0/ 3. 5 I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
GASTROENTERO
* GASTROENTERO LOGI C LLC
OMEPRAZOLE AND CLARI THROMYCI N AND AMOXI CI LLI N, AMOXI CI LLI N
GATE PHARMS
* GATE PHARMACEUTI CALS
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
GAVI S PHARMS
* GAVI S PHARMACEUTI CALS LLC
ACETAMI NOPHEN AND PENTAZOCI NE HYDROCHLORI DE, ACETAMI NOPHEN
NALOXONE HYDROCHLORI DE AND PENTAZOCI NE HYDROCHLORI DE, NALOXONE HYDROCHLORI DE
NYSTATI N, NYSTATI N
ORPHENADRI NE CI TRATE, ORPHENADRI NE CI TRATE
QUI NARETI C, HYDROCHLOROTHI AZI DE
TRI METHOBENZAMI DE HYDROCHLORI DE, TRI METHOBENZAMI DE HYDROCHLORI DE
GD SEARLE
* GD SEARLE LLC
CELEBREX, CELECOXI B
DAYPRO, OXAPROZI N
GD SEARLE LLC
* GD SEARLE LLC
ALDACTAZI DE, HYDROCHLOROTHI AZI DE
ALDACTONE, SPI RONOLACTONE
ARTHROTEC, DI CLOFENAC SODI UM
CALAN, VERAPAMI L HYDROCHLORI DE
COVERA- HS, VERAPAMI L HYDROCHLORI DE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 54
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * G * *
* GD SEARLE LLC
CYTOTEC, MI SOPROSTOL
FLAGYL ER, METRONI DAZOLE
FLAGYL, METRONI DAZOLE
I NSPRA, EPLERENONE
LOMOTI L, ATROPI NE SULFATE
NORPACE CR, DI SOPYRAMI DE PHOSPHATE
NORPACE, DI SOPYRAMI DE PHOSPHATE
SYNAREL, NAFARELI N ACETATE
GE HEALTHCARE
* GE HEALTHCARE
ADREVI EW, I OBENGUANE SULFATE I - 123
CERETEC, TECHNETI UM TC- 99M EXAMETAZI ME KI T
I NDI CLOR, I NDI UM I N- 111 CHLORI DE
I NDI UM I N- 111 OXYQUI NOLI NE, I NDI UM I N- 111 OXYQUI NOLI NE
METASTRON, STRONTI UM CHLORI DE SR- 89
MPI DMSA KI DNEY REAGENT, TECHNETI UM TC- 99M SUCCI MER KI T
MPI I NDI UM DTPA I N 111, I NDI UM I N- 111 PENTETATE DI SODI UM
MYOVI EW30ML, TECHNETI UM TC- 99M TETROFOSMI N KI T
MYOVI EW, TECHNETI UM TC- 99M TETROFOSMI N KI T
OMNI PAQUE 140, I OHEXOL
OMNI PAQUE 180, I OHEXOL
OMNI PAQUE 240, I OHEXOL
OMNI PAQUE 300, I OHEXOL
OMNI PAQUE 350, I OHEXOL
OMNI SCAN, GADODI AMI DE
OPTI SON, ALBUMI N HUMAN
THALLOUS CHLORI DE TL 201, THALLOUS CHLORI DE TL- 201
VI SI PAQUE 270, I ODI XANOL
VI SI PAQUE 320, I ODI XANOL
VI ZAMYL, FLUTEMETAMOL F- 18
GE HLTHCARE I NC
* GE HEALTHCARE I NC
DATSCAN, I OFLUPANE I - 123
GEDEON RI CHTER USA
* GEDEON RI CHTER USA I NC
FI NASTERI DE, FI NASTERI DE
GENENTECH
* GENENTECH I NC
ERI VEDGE, VI SMODEGI B
NUTROPI N AQ PEN, SOMATROPI N RECOMBI NANT
NUTROPI N AQ, SOMATROPI N RECOMBI NANT
NUTROPI N, SOMATROPI N RECOMBI NANT
GENZYME
* GENZYME CORP
CEREZYME, I MI GLUCERASE
CLOLAR, CLOFARABI NE
MOZOBI L, PLERI XAFOR
RENAGEL, SEVELAMER HYDROCHLORI DE
RENVELA, SEVELAMER CARBONATE
THYROGEN, THYROTROPI N ALFA
GENZYME CORP
* GENZYME CORP
HECTOROL, DOXERCALCI FEROL
KYNAMRO, MI POMERSEN SODI UM
GI LEAD
* GI LEAD SCI ENCES I NC
ATRI PLA, EFAVI RENZ
CAYSTON, AZTREONAM
EMTRI VA, EMTRI CI TABI NE
HEPSERA, ADEFOVI R DI PI VOXI L
LETAI RI S, AMBRI SENTAN
RANEXA, RANOLAZI NE
TRUVADA, EMTRI CI TABI NE
GI LEAD SCI ENCES I NC



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 55
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * G * *
* GI LEAD SCI ENCES I NC
COMPLERA, EMTRI CI TABI NE
SOVALDI , SOFOSBUVI R
STRI BI LD, COBI CI STAT
VI READ, TENOFOVI R DI SOPROXI L FUMARATE
VI STI DE, CI DOFOVI R
GLAND PHARMA LTD
* GLAND PHARMA LTD
ADENOSI NE, ADENOSI NE
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
AZI THROMYCI N, AZI THROMYCI N
HALOPERI DOL, HALOPERI DOL LACTATE
LABETALOL HYDROCHLORI DE, LABETALOL HYDROCHLORI DE
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
MI LRI NONE LACTATE, MI LRI NONE LACTATE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
GLATT AI R
* GLATT AI R TECHNI QUES I NC
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
GLAXO GRP LTD
* GLAXO GROUP LTD DBA GLAXOSMI THKLI NE
ALTABAX, RETAPAMULI N
FLOVENT HFA, FLUTI CASONE PROPI ONATE
SEREVENT, SALMETEROL XI NAFOATE
* GLAXO GROUP LTD ENGLAND DBA GLAXOSMI THKLI NE
ADVAI R DI SKUS 100/ 50, FLUTI CASONE PROPI ONATE
ADVAI R DI SKUS 250/ 50, FLUTI CASONE PROPI ONATE
ADVAI R DI SKUS 500/ 50, FLUTI CASONE PROPI ONATE
ADVAI R HFA, FLUTI CASONE PROPI ONATE
ANORO ELLI PTA, UMECLI DI NI UM BROMI DE
BREO ELLI PTA, FLUTI CASONE FUROATE
FLOVENT DI SKUS 100, FLUTI CASONE PROPI ONATE
FLOVENT DI SKUS 250, FLUTI CASONE PROPI ONATE
FLOVENT DI SKUS 50, FLUTI CASONE PROPI ONATE
VENTOLI N HFA, ALBUTEROL SULFATE
ZANTAC 150, RANI TI DI NE HYDROCHLORI DE
ZANTAC 25, RANI TI DI NE HYDROCHLORI DE
ZANTAC 300, RANI TI DI NE HYDROCHLORI DE
ZANTAC, RANI TI DI NE HYDROCHLORI DE
GLAXO WELLCOME
* GLAXOSMI THKLI NE
HYCAMTI N, TOPOTECAN HYDROCHLORI DE
GLAXOSMI THKLI NE
* GLAXOSMI THKLI NE
ABREVA, DOCOSANOL ( OTC)
ALKERAN, MELPHALAN
ALKERAN, MELPHALAN HYDROCHLORI DE
ARI XTRA, FONDAPARI NUX SODI UM
AVODART, DUTASTERI DE
BACTROBAN, MUPI ROCI N
BACTROBAN, MUPI ROCI N CALCI UM
BECONASE AQ, BECLOMETHASONE DI PROPI ONATE MONOHYDRATE
CEFTI N, CEFUROXI ME AXETI L
EPI VI R- HBV, LAMI VUDI NE
FLONASE, FLUTI CASONE PROPI ONATE
HYCAMTI N, TOPOTECAN HYDROCHLORI DE
I MI TREX STATDOSE, SUMATRI PTAN SUCCI NATE
I MI TREX, SUMATRI PTAN
I MI TREX, SUMATRI PTAN SUCCI NATE
J ALYN, DUTASTERI DE
MALARONE PEDI ATRI C, ATOVAQUONE
MALARONE, ATOVAQUONE
NI CORETTE ( MI NT) , NI COTI NE POLACRI LEX ( OTC)
NI CORETTE, NI COTI NE POLACRI LEX ( OTC)



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 56
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * G * *
* GLAXOSMI THKLI NE
PAXI L CR, PAROXETI NE HYDROCHLORI DE
PAXI L, PAROXETI NE HYDROCHLORI DE
POTI GA, EZOGABI NE
PROMACTA, ELTROMBOPAG OLAMI NE
RELENZA, ZANAMI VI R
TAFI NLAR, DABRAFENI B MESYLATE
TAGAMET, CI METI DI NE
TI MENTI N I N PLASTI C CONTAI NER, CLAVULANATE POTASSI UM
TI MENTI N, CLAVULANATE POTASSI UM
VALTREX, VALACYCLOVI R HYDROCHLORI DE
VERAMYST, FLUTI CASONE FUROATE
VOTRI ENT, PAZOPANI B HYDROCHLORI DE
WELLBUTRI N SR, BUPROPI ON HYDROCHLORI DE
WELLBUTRI N, BUPROPI ON HYDROCHLORI DE
ZOFRAN ODT, ONDANSETRON
ZOFRAN PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ZOFRAN, ONDANSETRON HYDROCHLORI DE
ZOVI RAX, ACYCLOVI R
ZYBAN, BUPROPI ON HYDROCHLORI DE
GLAXOSMI THKLI NE CONS
* GLAXOSMI THKLI NE CONSUMER HEALTHCARE
ALLI , ORLI STAT ( OTC)
COMMI T, NI COTI NE POLACRI LEX ( OTC)
NI CORETTE, NI COTI NE POLACRI LEX ( OTC)
GLAXOSMI THKLI NE LLC
* GLAXOSMI THKLI NE LLC
AMERGE, NARATRI PTAN HYDROCHLORI DE
DYAZI DE, HYDROCHLOROTHI AZI DE
FLOLAN, EPOPROSTENOL SODI UM
I NNOPRAN XL, PROPRANOLOL HYDROCHLORI DE
LAMI CTAL CD, LAMOTRI GI NE
LAMI CTAL ODT, LAMOTRI GI NE
LAMI CTAL XR, LAMOTRI GI NE
LAMI CTAL, LAMOTRI GI NE
MEKI NI ST, TRAMETI NI B DI METHYL SULFOXI DE
MEPRON, ATOVAQUONE
REQUI P XL, ROPI NI ROLE HYDROCHLORI DE
REQUI P, ROPI NI ROLE HYDROCHLORI DE
RYTHMOL SR, PROPAFENONE HYDROCHLORI DE
RYTHMOL, PROPAFENONE HYDROCHLORI DE
GLENMARK GENERI CS
* GLENMARK GENERI CS I NC USA
ADAPALENE, ADAPALENE
BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
CALCI POTRI ENE, CALCI POTRI ENE
DI PYRI DAMOLE, DI PYRI DAMOLE
I MI QUI MOD, I MI QUI MOD
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPI ROCI N, MUPI ROCI N CALCI UM
NI ZATI DI NE, NI ZATI DI NE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
ZONI SAMI DE, ZONI SAMI DE
* GLENMARK GENERI CS LI MI TED
BRI ELLYN, ETHI NYL ESTRADI OL
FLUTI CASONE PROPI ONATE, FLUTI CASONE PROPI ONATE
LEVOCETI RI ZI NE DI HYDROCHLORI DE, LEVOCETI RI ZI NE DI HYDROCHLORI DE
* GLENMARK GENERI CS LTD
ACAMPROSATE CALCI UM, ACAMPROSATE CALCI UM
ALCLOMETASONE DI PROPI ONATE, ALCLOMETASONE DI PROPI ONATE
ALYACEN 1/ 35, ETHI NYL ESTRADI OL
ALYACEN 7/ 7/ 7, ETHI NYL ESTRADI OL
ATOVAQUONE AND PROGUANI L HYDROCHLORI DE, ATOVAQUONE
CARVEDI LOL, CARVEDI LOL
CI CLOPI ROX, CI CLOPI ROX



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 57
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * G * *
* GLENMARK GENERI CS LTD
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
DESOXI METASONE, DESOXI METASONE
FELODI PI NE, FELODI PI NE
FLUCONAZOLE, FLUCONAZOLE
GABAPENTI N, GABAPENTI N
HEATHER, NORETHI NDRONE
HYDROCORTI SONE BUTYRATE, HYDROCORTI SONE BUTYRATE
LAMOTRI GI NE, LAMOTRI GI NE
LEVOFLOXACI N, LEVOFLOXACI N
LI THI UM CARBONATE, LI THI UM CARBONATE
MARLI SSA, ETHI NYL ESTRADI OL
MELOXI CAM, MELOXI CAM
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
MOEXI PRI L HYDROCHLORI DE, MOEXI PRI L HYDROCHLORI DE
MOMETASONE FUROATE, MOMETASONE FUROATE
MONTELUKAST SODI UM, MONTELUKAST SODI UM
NAPROXEN SODI UM, NAPROXEN SODI UM
NAPROXEN, NAPROXEN
NORETHI DRONE, NORETHI NDRONE
NORGESTI MATE AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON, ONDANSETRON
OXCARBAZEPI NE, OXCARBAZEPI NE
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM
RI LUZOLE, RI LUZOLE
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
SULFAMETHOXAZOLE AND TRI METHOPRI M, SULFAMETHOXAZOLE
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
THEOPHYLLI NE, THEOPHYLLI NE
TOPI RAMATE, TOPI RAMATE
TRANDOLAPRI L AND VERAPAMI L HYDROCHLORI DE, TRANDOLAPRI L
TROSPI UM CHLORI DE, TROSPI UM CHLORI DE
URSODI OL, URSODI OL
VERAPAMI L HYDROCHLORI DE, VERAPAMI L HYDROCHLORI DE
VI ORELE, DESOGESTREL
ZOLMI TRI PTAN, ZOLMI TRI PTAN
* GLENMARK GENERI CS LTD I NDI A
I NDOMETHACI N, I NDOMETHACI N
LI THI UM CARBONATE, LI THI UM CARBONATE
NORETHI NDRONE ACETATE, NORETHI NDRONE ACETATE
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
GLENMARK PHARMS
* GLENMARK PHARMACEUTI CALS I NC USA
CI CLOPI ROX, CI CLOPI ROX
CLOTRI MAZOLE, CLOTRI MAZOLE
MUPI ROCI N, MUPI ROCI N
* GLENMARK PHARMACEUTI CALS LTD
MOEXI PRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
GLENMARK PHARMS LTD
* GLENMARK PHARMACEUTI CALS LTD
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
GRANULES I NDI A
* GRANULES I NDI A LTD
I BUPROFEN, I BUPROFEN ( OTC)
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
NAPROXEN SODI UM, NAPROXEN SODI UM ( OTC)
GUARDI AN DRUG
* GUARDI AN DRUG CO I NC
FOAMCOAT, ALUMI NUM HYDROXI DE ( OTC)
GUERBET
* GUERBET LLC
DOTAREM, GADOTERATE MEGLUMI NE
HEXABRI X, I OXAGLATE MEGLUMI NE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 58
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * G * *
* GUERBET LLC
OXI LAN- 300, I OXI LAN
OXI LAN- 350, I OXI LAN
HANFORD GC
* GC HANFORD MANUFACTURI NG CO
AMPI CI LLI N AND SULBACTAM, AMPI CI LLI N SODI UM
AMPI CI LLI N SODI UM, AMPI CI LLI N SODI UM
PENI CI LLI N G POTASSI UM, PENI CI LLI N G POTASSI UM
* * H * *
HAEMONETI CS
* HAEMONETI CS CORP
SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
HALOCARBON PRODS
* HALOCARBON PRODUCTS CORP
I SOFLURANE, I SOFLURANE
SEVOFLURANE, SEVOFLURANE
HALOZYME THERAP
* HALOZYME THERAPEUTI CS I NC
HYLENEX RECOMBI NANT, HYALURONI DASE RECOMBI NANT HUMAN
HAMELN RDS GMBH
* HAMELN RDS GMBH
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
HANMI PHARM CO LTD
* HANMI PHARMACEUTI CAL CO LTD
ESOMEPRAZOLE STRONTI UM, ESOMEPRAZOLE STRONTI UM
HARRI S PHARM
* HARRI S PHARMACEUTI CAL I NC
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
HAUPT PHARMA
* HAUPT PHARMA I NC
NORETHI NDRONE, NORETHI NDRONE
HELSI NN HLTHCARE
* HELSI NN HEALTHCARE SA
ALOXI , PALONOSETRON HYDROCHLORI DE
HERCON PHARM
* HERCON PHARMACEUTI CAL LLC
NI TROGLYCERI N, NI TROGLYCERI N
HERI TAGE PHARMS I NC
* HERI TAGE PHARMACEUTI CALS I NC
ACETAZOLAMI DE, ACETAZOLAMI DE
ACHROMYCI N V, TETRACYCLI NE HYDROCHLORI DE
CARI SOPRODOL AND ASPI RI N, ASPI RI N
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
DOXYCYCLI NE, DOXYCYCLI NE
FELODI PI NE, FELODI PI NE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
GLI PI ZI DE AND METFORMI N HYDROCHLORI DE, GLI PI ZI DE
GLYBURI DE AND METFORMI N HYDROCHLORI DE, GLYBURI DE
GLYBURI DE, GLYBURI DE
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
I NDOMETHACI N, I NDOMETHACI N
LEFLUNOMI DE, LEFLUNOMI DE
NARATRI PTAN, NARATRI PTAN HYDROCHLORI DE
NYSTATI N, NYSTATI N
PAROMOMYCI N SULFATE, PAROMOMYCI N SULFATE
SULI NDAC, SULI NDAC
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
VERAPAMI L HYDROCHLORI DE, VERAPAMI L HYDROCHLORI DE
HETERO LABS LTD I I I
* HETERO LABS LTD UNI T I I I
ABACAVI R SULFATE, ABACAVI R SULFATE



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 59
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * H * *
* HETERO LABS LTD UNI T I I I
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
FI NASTERI DE, FI NASTERI DE
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
I NDOMETHACI N, I NDOMETHACI N
LEVETI RACETAM, LEVETI RACETAM
LEVOCETI RI ZI NE DI HYDROCHLORI DE, LEVOCETI RI ZI NE DI HYDROCHLORI DE
LI THI UM CARBONATE, LI THI UM CARBONATE
METHOCARBAMOL, METHOCARBAMOL
NEVI RAPI NE, NEVI RAPI NE
STAVUDI NE, STAVUDI NE
TORSEMI DE, TORSEMI DE
ZI DOVUDI NE, ZI DOVUDI NE
HETERO LABS LTD V
* HETERO LABS LTD UNI T V
ACYCLOVI R, ACYCLOVI R
I RBESARTAN, I RBESARTAN
LAMI VUDI NE, LAMI VUDI NE
HEYL CHEMI SCH
* HEYL CHEMI SCH PHARMAZEUTI SHE FABRI K
RADI OGARDASE ( PRUSSI AN BLUE) , FERRI C HEXACYANOFERRATE( I I )
HI TECH PHARMA
* HI TECH PHARMACAL CO I NC
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
ACYCLOVI R, ACYCLOVI R
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMANTADI NE HYDROCHLORI DE, AMANTADI NE HYDROCHLORI DE
CALCI POTRI ENE, CALCI POTRI ENE
CHLORHEXI DI NE GLUCONATE, CHLORHEXI DI NE GLUCONATE
CI CLOPI ROX, CI CLOPI ROX
CI METI DI NE HYDROCHLORI DE, CI METI DI NE HYDROCHLORI DE
CORMAX, CLOBETASOL PROPI ONATE
DORZOLAMI DE HYDROCHLORI DE AND TI MOLOL MALEATE, DORZOLAMI DE HYDROCHLORI DE
DORZOLAMI DE HYDROCHLORI DE, DORZOLAMI DE HYDROCHLORI DE
EMBELI NE E, CLOBETASOL PROPI ONATE
EMBELI NE, CLOBETASOL PROPI ONATE
ERYTHRO- STATI N, ERYTHROMYCI N
FLUTI CASONE PROPI ONATE, FLUTI CASONE PROPI ONATE
GABAPENTI N, GABAPENTI N
HYDROCODONE BI TARTRATE AND HOMATROPI NE METHYLBROMI DE, HOMATROPI NE METHYLBROMI DE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
LACTULOSE, LACTULOSE
LEVOCARNI TI NE, LEVOCARNI TI NE
LEVOFLOXACI N, LEVOFLOXACI N
LI DOCAI NE AND PRI LOCAI NE, LI DOCAI NE
LI DOCAI NE HYDROCHLORI DE, LI DOCAI NE HYDROCHLORI DE
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE ( OTC)
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
MI NOXI DI L ( FOR MEN) , MI NOXI DI L ( OTC)
MI NOXI DI L ( FOR WOMEN) , MI NOXI DI L ( OTC)
NYSTATI N, NYSTATI N
OFLOXACI N, OFLOXACI N
PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
PROMETHAZI NE HYDROCHLORI DE AND CODEI NE PHOSPHATE, CODEI NE PHOSPHATE
PROMETHAZI NE HYDROCHLORI DE AND DEXTROMETHORPHAN HYDROBROMI DE, DEXTROMETHORPHAN
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
SULFAMETHOXAZOLE AND TRI METHOPRI M, SULFAMETHOXAZOLE
TI MOLOL MALEATE, TI MOLOL MALEATE
VOSOL HC, ACETI C ACI D, GLACI AL
VOSOL, ACETI C ACI D, GLACI AL
HI TECH PHARMA CO
* HI TECH PHARMACAL CO I NC
FLUNI SOLI DE, FLUNI SOLI DE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 60
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * H * *
* HI TECH PHARMACAL CO I NC
PREDNI SOLONE, PREDNI SOLONE
TUSSI CAPS, CHLORPHENI RAMI NE POLI STI REX
HI - TECH PHARMA CO
* HI - TECH PHARMACAL CO I NC
LORAZEPAM, LORAZEPAM
HI - TECH PHARMACAL
* HI - TECH PHARMACAL CO I NC
LEVETI RACETAM, LEVETI RACETAM
HI GH TECH PHARMA
* HI GH TECHNOLOGY PHARMACAL CO I NC
VALPROI C ACI D, VALPROI C ACI D
HI KMA
* HI KMA FARMACEUTI CA LDA
CEFOTAXI ME, CEFOTAXI ME SODI UM
* HI KMA PHARMACEUTI CALS
AMOXI CI LLI N, AMOXI CI LLI N
CARVEDI LOL, CARVEDI LOL
CEFACLOR, CEFACLOR
CEFADROXI L, CEFADROXI L/ CEFADROXI L HEMI HYDRATE
CEPHALEXI N, CEPHALEXI N
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
GABAPENTI N, GABAPENTI N
GLYBURI DE ( MI CRONI ZED) , GLYBURI DE
NAPROXEN SODI UM, NAPROXEN SODI UM
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
HI KMA ( MAPLE)
* HI KMA ( MAPLE) LTD
SODI UM CHLORI DE 0. 9%, SODI UM CHLORI DE
HI KMA FARMACEUTI CA
* HI KMA FARMACEUTI CA ( PORTUGAL) SA
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
BENZTROPI NE MESYLATE, BENZTROPI NE MESYLATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CEFOXI TI N, CEFOXI TI N SODI UM
CEFTRI AXONE, CEFTRI AXONE SODI UM
CI PROFLOXACI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, CI PROFLOXACI N
CI PROFLOXACI N, CI PROFLOXACI N
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
ENALAPRI LAT, ENALAPRI LAT
FLUCONAZOLE I N DEXTROSE 5%I N PLASTI C CONTAI NER, FLUCONAZOLE
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, FLUCONAZOLE
FLUMAZENI L, FLUMAZENI L
FOSPHENYTOI N SODI UM, FOSPHENYTOI N SODI UM
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANI STERON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
LEVETI RACETAM, LEVETI RACETAM
LEVOFLOXACI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, LEVOFLOXACI N
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MI LRI NONE LACTATE I N PLASTI C CONTAI NER, MI LRI NONE LACTATE
MI LRI NONE LACTATE, MI LRI NONE LACTATE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
PROGESTERONE, PROGESTERONE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
TERBUTALI NE SULFATE, TERBUTALI NE SULFATE
TESTOSTERONE CYPI ONATE, TESTOSTERONE CYPI ONATE
VALPROATE SODI UM, VALPROATE SODI UM
* HI KMA FARMACEUTI CA PORTUGAL LDA
CEFAZOLI N SODI UM, CEFAZOLI N SODI UM
CEFUROXI ME SODI UM, CEFUROXI ME SODI UM
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%, FLUCONAZOLE
* HI KMA FARMACEUTI CA PORTUGAL SA
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 61
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * H * *
* HI KMA FARMACEUTI CA PORTUGAL SA
OXYTOCI N, OXYTOCI N
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
* HI KMA FARMACEUTI CA SA
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
HI KMA MAPLE
* HI KMA MAPLE LTD
ACYCLOVI R I N SODI UM CHLORI DE 0. 9%PRESERVATI VE FREE, ACYCLOVI R SODI UM
ACYCLOVI R SODI UM, ACYCLOVI R SODI UM
ADENOSI NE, ADENOSI NE
AMPI CI LLI N AND SULBACTAM, AMPI CI LLI N SODI UM
BUMETANI DE, BUMETANI DE
CEFOXI TI N, CEFOXI TI N SODI UM
CHLORPROMAZI NE HYDROCHLORI DE, CHLORPROMAZI NE HYDROCHLORI DE
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
DEXAMETHASONE SODI UM PHOSPHATE, DEXAMETHASONE SODI UM PHOSPHATE
DI GOXI N, DI GOXI N
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
DI PHENHYDRAMI NE HYDROCHLORI DE, DI PHENHYDRAMI NE HYDROCHLORI DE
DI PYRI DAMOLE, DI PYRI DAMOLE
DOPRAM, DOXAPRAM HYDROCHLORI DE
DURAMORPH PF, MORPHI NE SULFATE
FAMOTI DI NE PRESERVATI VE FREE, FAMOTI DI NE
FAMOTI DI NE, FAMOTI DI NE
FENTANYL CI TRATE PRESERVATI VE FREE, FENTANYL CI TRATE
FLUMAZENI L, FLUMAZENI L
FOSPHENYTOI N SODI UM, FOSPHENYTOI N SODI UM
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
HEPARI N SODI UM, HEPARI N SODI UM
I NFUMORPH, MORPHI NE SULFATE
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
MEPERI DI NE HYDROCHLORI DE PRESERVATI VE FREE, MEPERI DI NE HYDROCHLORI DE
MEPERI DI NE HYDROCHLORI DE, MEPERI DI NE HYDROCHLORI DE
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
MI LRI NONE LACTATE, MI LRI NONE LACTATE
MI TOMYCI N, MI TOMYCI N
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
PHENYTOI N SODI UM, PHENYTOI N SODI UM
PROCHLORPERAZI NE EDI SYLATE, PROCHLORPERAZI NE EDI SYLATE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
ROBAXI N, METHOCARBAMOL
ROBI NUL, GLYCOPYRROLATE
SODI UM CHLORI DE 0. 9%, SODI UM CHLORI DE
SUFENTANI L CI TRATE, SUFENTANI L CI TRATE
TOBRAMYCI N SULFATE, TOBRAMYCI N SULFATE
VI NORELBI NE TARTRATE, VI NORELBI NE TARTRATE
HI KMA PHARM CO LTD
* HI KMA PHARM CO LTD
ARGATROBAN, ARGATROBAN
HI KMA PHARMS
* HI KMA PHARMACEUTI CALS
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
AMOXI CI LLI N AND CLAVULANATE POTASSI UM, AMOXI CI LLI N
AMOXI CI LLI N, AMOXI CI LLI N
CEFADROXI L, CEFADROXI L/ CEFADROXI L HEMI HYDRATE
CEPHALEXI N, CEPHALEXI N
DI GOXI N, DI GOXI N
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
GABAPENTI N, GABAPENTI N
GEMFI BROZI L, GEMFI BROZI L
GLI MEPI RI DE, GLI MEPI RI DE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 62
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * H * *
* HI KMA PHARMACEUTI CALS
I SOSORBI DE MONONI TRATE, I SOSORBI DE MONONI TRATE
LAMOTRI GI NE, LAMOTRI GI NE
LI SI NOPRI L, LI SI NOPRI L
METHOCARBAMOL, METHOCARBAMOL
MODAFI NI L, MODAFI NI L
PENI CI LLI N V POTASSI UM, PENI CI LLI N V POTASSI UM
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TOPI RAMATE , TOPI RAMATE
* HI KMA PHARMACEUTI CALS LLC
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
PREDNI SONE, PREDNI SONE
SODI UM FERRI C GLUCONATE COMPLEX I N SUCROSE, SODI UM FERRI C GLUCONATE COMPLEX
HI KMA PHARMS LLC
* HI KMA PHARMACEUTI CALS LLC
DOXERCALCI FEROL, DOXERCALCI FEROL
LI SI NOPRI L AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
HI LL DERMAC
* HI LL DERMACEUTI CALS I NC
DERMA- SMOOTHE/ FS, FLUOCI NOLONE ACETONI DE
DERMOTI C, FLUOCI NOLONE ACETONI DE
HI SAMI TSU PHARM CO
* HI SAMI TSU PHARMACEUTI CAL CO I NC
SALONPAS, MENTHOL ( OTC)
HI SUN PHARM HANGZHOU
* HI SUN PHARMACEUTI CAL ( HANGZHOU) CO LTD
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
HI TECH PHARMA
* HI TECH PHARMACAL CORP
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
HOFFMAN LA ROCHE
* HOFFMAN LA ROCHE I NC
I NVI RASE, SAQUI NAVI R MESYLATE
HOFFMANN LA ROCHE
* HOFFMANN LA ROCHE I NC
ANAPROX DS, NAPROXEN SODI UM
ANAPROX, NAPROXEN SODI UM
BONI VA, I BANDRONATE SODI UM
I NVI RASE, SAQUI NAVI R MESYLATE
ROCEPHI N, CEFTRI AXONE SODI UM
VALCYTE, VALGANCI CLOVI R HYDROCHLORI DE
XELODA, CAPECI TABI NE
XENI CAL, ORLI STAT
ZELBORAF, VEMURAFENI B
HOPE PHARMS
* HOPE PHARMACEUTI CALS
NI THI ODOTE, SODI UM NI TRI TE
SODI UM NI TRI TE, SODI UM NI TRI TE
SODI UM THI OSULFATE, SODI UM THI OSULFATE
HORI ZON PHARMA
* HORI ZON PHARMA I NC
DUEXI S, FAMOTI DI NE
RAYOS, PREDNI SONE
VI MOVO, ESOMEPRAZOLE MAGNESI UM
HOSPI RA
* HOSPI RA I NC
A- HYDROCORT, HYDROCORTI SONE SODI UM SUCCI NATE
A- METHAPRED, METHYLPREDNI SOLONE SODI UM SUCCI NATE
ACETI C ACI D 0. 25%I N PLASTI C CONTAI NER, ACETI C ACI D, GLACI AL
ACETYLCYSTEI NE, ACETYLCYSTEI NE
ALFENTANI L, ALFENTANI L HYDROCHLORI DE
AMI DATE, ETOMI DATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 63
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * H * *
* HOSPI RA I NC
AMI NOCAPROI C ACI D I N PLASTI C CONTAI NER, AMI NOCAPROI C ACI D
AMI NOPHYLLI NE, AMI NOPHYLLI NE
AMI NOSYN 10%( PH6) , AMI NO ACI DS
AMI NOSYN 10%, AMI NO ACI DS
AMI NOSYN 3. 5%M, AMI NO ACI DS
AMI NOSYN 3. 5%, AMI NO ACI DS
AMI NOSYN 5%, AMI NO ACI DS
AMI NOSYN 7%( PH6) , AMI NO ACI DS
AMI NOSYN 7%W/ ELECTROLYTES, AMI NO ACI DS
AMI NOSYN 7%, AMI NO ACI DS
AMI NOSYN 8. 5%( PH6) , AMI NO ACI DS
AMI NOSYN 8. 5%W/ ELECTROLYTES, AMI NO ACI DS
AMI NOSYN 8. 5%, AMI NO ACI DS
AMI NOSYN I I 10%I N PLASTI C CONTAI NER, AMI NO ACI DS
AMI NOSYN I I 10%W/ ELECTROLYTES, AMI NO ACI DS
AMI NOSYN I I 10%, AMI NO ACI DS
AMI NOSYN I I 15%I N PLASTI C CONTAI NER, AMI NO ACI DS
AMI NOSYN I I 7%, AMI NO ACI DS
AMI NOSYN I I 8. 5%W/ ELECTROLYTES, AMI NO ACI DS
AMI NOSYN I I 8. 5%, AMI NO ACI DS
AMI NOSYN- HBC 7%, AMI NO ACI DS
AMI NOSYN- HF 8%, AMI NO ACI DS
AMI NOSYN- PF 10%, AMI NO ACI DS
AMI NOSYN- PF 7%, AMI NO ACI DS
AMI NOSYN- RF 5. 2%, AMI NO ACI DS
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
AMMONI UM CHLORI DE I N PLASTI C CONTAI NER, AMMONI UM CHLORI DE
AQUASOL A, VI TAMI N A PALMI TATE
ARTI CAI NE HYDROCHLORI DE AND EPI NEPHRI NE BI TARTRATE, ARTI CAI NE HYDROCHLORI DE
ATROPI NE SULFATE ANSYR PLASTI C SYRI NGE, ATROPI NE SULFATE
AZI THROMYCI N, AZI THROMYCI N
BACTERI OSTATI C SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
BACTERI OSTATI C WATER FOR I NJ ECTI ON I N PLASTI C CONTAI NER, STERI LE WATER FOR I NJ ECTI ON
BLEOMYCI N SULFATE, BLEOMYCI N SULFATE
BUMETANI DE, BUMETANI DE
BUPI VACAI NE HYDROCHLORI DE AND EPI NEPHRI NE, BUPI VACAI NE HYDROCHLORI DE
BUPI VACAI NE HYDROCHLORI DE W/ EPI NEPHRI NE, BUPI VACAI NE HYDROCHLORI DE
BUPI VACAI NE HYDROCHLORI DE, BUPI VACAI NE HYDROCHLORI DE
BUPRENORPHI NE HYDROCHLORI DE, BUPRENORPHI NE HYDROCHLORI DE
BUTORPHANOL TARTRATE PRESERVATI VE FREE, BUTORPHANOL TARTRATE
CALCI UM CHLORI DE 10%I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
CARBOCAI NE, MEPI VACAI NE HYDROCHLORI DE
CARBOPLATI N, CARBOPLATI N
CHLOROPROCAI NE HYDROCHLORI DE, CHLOROPROCAI NE HYDROCHLORI DE
CHROMI C CHLORI DE I N PLASTI C CONTAI NER, CHROMI C CHLORI DE
CI PROFLOXACI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, CI PROFLOXACI N
CI PROFLOXACI N, CI PROFLOXACI N
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
CORLOPAM, FENOLDOPAM MESYLATE
CUPRI C CHLORI DE I N PLASTI C CONTAI NER, CUPRI C CHLORI DE
CYTARABI NE, CYTARABI NE
DACARBAZI NE, DACARBAZI NE
DEFEROXAMI NE MESYLATE, DEFEROXAMI NE MESYLATE
DEMEROL, MEPERI DI NE HYDROCHLORI DE
DESMOPRESSI N ACETATE, DESMOPRESSI N ACETATE
DEXTROSE 10%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 20%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 25%, DEXTROSE
DEXTROSE 30%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 40%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DEXTROSE 5%AND RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER, DEXTROSE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 64
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * H * *
* HOSPI RA I NC
DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 50%I N PLASTI C CONTAI NER, DEXTROSE
DEXTROSE 70%I N PLASTI C CONTAI NER, DEXTROSE
DI AZEPAM, DI AZEPAM
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
DI PHENHYDRAMI NE HYDROCHLORI DE, DI PHENHYDRAMI NE HYDROCHLORI DE
DOBUTAMI NE HYDROCHLORI DE I N DEXTROSE 5%I N PLASTI C CONTAI NER, DOBUTAMI NE HYDROCHLORI DE
DOBUTAMI NE HYDROCHLORI DE I N DEXTROSE 5%, DOBUTAMI NE HYDROCHLORI DE
DOBUTAMI NE HYDROCHLORI DE, DOBUTAMI NE HYDROCHLORI DE
DOPAMI NE HYDROCHLORI DE I N DEXTROSE 5%I N PLASTI C CONTAI NER, DOPAMI NE HYDROCHLORI DE
DOPAMI NE HYDROCHLORI DE, DOPAMI NE HYDROCHLORI DE
DROPERI DOL, DROPERI DOL
ENALAPRI LAT, ENALAPRI LAT
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
ERYTHROCI N, ERYTHROMYCI N LACTOBI ONATE
FENTANYL CI TRATE PRESERVATI VE FREE, FENTANYL CI TRATE
FENTANYL CI TRATE, FENTANYL CI TRATE
FLUCONAZOLE I N DEXTROSE 5%I N PLASTI C CONTAI NER, FLUCONAZOLE
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, FLUCONAZOLE
FOSCARNET SODI UM, FOSCARNET SODI UM
FOSPHENYTOI N SODI UM, FOSPHENYTOI N SODI UM
FUROSEMI DE, FUROSEMI DE
GENTAMI CI N SULFATE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, GENTAMI CI N SULFATE
GENTAMI CI N SULFATE, GENTAMI CI N SULFATE
GLYCI NE 1. 5%I N PLASTI C CONTAI NER, GLYCI NE
HEPARI N SODI UM 1, 000 UNI TS I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, HEPARI N
HEPARI N SODI UM 10, 000 UNI TS I N DEXTROSE 5%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 12, 500 UNI TS I N DEXTROSE 5%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 12, 500 UNI TS I N SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, HEPARI N
HEPARI N SODI UM 2, 000 UNI TS I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, HEPARI N
HEPARI N SODI UM 20, 000 UNI TS I N DEXTROSE 5%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 25, 000 UNI TS I N DEXTROSE 5%I N PLASTI C CONTAI NER, HEPARI N SODI UM
HEPARI N SODI UM 25, 000 UNI TS I N SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, HEPARI N
HEPARI N SODI UM PRESERVATI VE FREE, HEPARI N SODI UM
HEPARI N SODI UM, HEPARI N SODI UM
HYDROMORPHONE HYDROCHLORI DE, HYDROMORPHONE HYDROCHLORI DE
I ONOSOL B AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
I ONOSOL MB AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
I SOFLURANE, I SOFLURANE
I SUPREL, I SOPROTERENOL HYDROCHLORI DE
KETAMI NE HYDROCHLORI DE, KETAMI NE HYDROCHLORI DE
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
LABETALOL HYDROCHLORI DE, LABETALOL HYDROCHLORI DE
LACTATED RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
LEVOPHED, NOREPI NEPHRI NE BI TARTRATE
LI DOCAI NE HYDROCHLORI DE 0. 4%I N DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE
LI DOCAI NE HYDROCHLORI DE 0. 8%I N DEXTROSE 5%I N PLASTI C CONTAI NER, LI DOCAI NE
LI DOCAI NE HYDROCHLORI DE 5%AND DEXTROSE 7. 5%, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE AND EPI NEPHRI NE, EPI NEPHRI NE
LI DOCAI NE HYDROCHLORI DE I N PLASTI C CONTAI NER, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE PRESERVATI VE FREE I N PLASTI C CONTAI NER, LI DOCAI NE
LI DOCAI NE HYDROCHLORI DE PRESERVATI VE FREE, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE, LI DOCAI NE HYDROCHLORI DE
LI POSYN I I 10%, SAFFLOWER OI L
LI POSYN I I 20%, SAFFLOWER OI L
LI POSYN I I I 10%, SOYBEAN OI L
LI POSYN I I I 20%, SOYBEAN OI L
LI POSYN I I I 30%, SOYBEAN OI L
LORAZEPAM, LORAZEPAM
LTA I I KI T, LI DOCAI NE HYDROCHLORI DE
M. V. I . ADULT ( PHARMACY BULK PACKAGE) , ASCORBI C ACI D
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 65
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * H * *
* HOSPI RA I NC
M. V. I . ADULT, ASCORBI C ACI D
M. V. I . PEDI ATRI C, ASCORBI C ACI D
M. V. I . - 12 ( WI THOUT VI TAMI N K) , ASCORBI C ACI D
MAGNESI UM SULFATE I N DEXTROSE 5%I N PLASTI C CONTAI NER, MAGNESI UM SULFATE
MAGNESI UM SULFATE I N PLASTI C CONTAI NER, MAGNESI UM SULFATE
MAGNESI UM SULFATE, MAGNESI UM SULFATE
MANGANESE CHLORI DE I N PLASTI C CONTAI NER, MANGANESE CHLORI DE
MANNI TOL 10%I N PLASTI C CONTAI NER, MANNI TOL
MANNI TOL 15%I N PLASTI C CONTAI NER, MANNI TOL
MANNI TOL 20%I N PLASTI C CONTAI NER, MANNI TOL
MANNI TOL 25%, MANNI TOL
MANNI TOL 5%I N PLASTI C CONTAI NER, MANNI TOL
MARCAI NE HYDROCHLORI DE PRESERVATI VE FREE, BUPI VACAI NE HYDROCHLORI DE
MARCAI NE HYDROCHLORI DE W/ EPI NEPHRI NE PRESERVATI VE FREE, BUPI VACAI NE HYDROCHLORI DE
MARCAI NE HYDROCHLORI DE W/ EPI NEPHRI NE, BUPI VACAI NE HYDROCHLORI DE
MARCAI NE HYDROCHLORI DE, BUPI VACAI NE HYDROCHLORI DE
MARCAI NE, BUPI VACAI NE HYDROCHLORI DE
MEPERI DI NE HYDROCHLORI DE PRESERVATI VE FREE, MEPERI DI NE HYDROCHLORI DE
METHOTREXATE SODI UM PRESERVATI VE FREE, METHOTREXATE SODI UM
METHOTREXATE SODI UM, METHOTREXATE SODI UM
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONI DAZOLE I N PLASTI C CONTAI NER, METRONI DAZOLE
MI DAZOLAM HYDROCHLORI DE PRESERVATI VE FREE, MI DAZOLAM HYDROCHLORI DE
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
MI LRI NONE LACTATE I N DEXTROSE 5%I N PLASTI C CONTAI NER, MI LRI NONE LACTATE
MORPHI NE SULFATE, MORPHI NE SULFATE
NALBUPHI NE HYDROCHLORI DE, NALBUPHI NE HYDROCHLORI DE
NALOXONE HYDROCHLORI DE, NALOXONE HYDROCHLORI DE
NI TROGLYCERI N I N DEXTROSE 5%, NI TROGLYCERI N
NORMOSOL- M AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
NORMOSOL- R AND DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
NORMOSOL- R I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
PACLI TAXEL, PACLI TAXEL
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
PANCURONI UM BROMI DE, PANCURONI UM BROMI DE
PHENYTOI N SODI UM, PHENYTOI N SODI UM
PHYSI OSOL I N PLASTI C CONTAI NER, MAGNESI UM CHLORI DE
PLEGI SOL I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
POTASSI UM ACETATE I N PLASTI C CONTAI NER, POTASSI UM ACETATE
POTASSI UM CHLORI DE 0. 149%I N SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, POTASSI UM
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 10MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 10MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 15MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C
POTASSI UM CHLORI DE 15MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 15MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 15MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE 20MEQ I N DEXTROSE 5%I N SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 20MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 20MEQ I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, POTASSI UM
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 66
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * H * *
* HOSPI RA I NC
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 30MEQ I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE 30MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND LACTATED RI NGER' S I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 40MEQ I N DEXTROSE 5%I N PLASTI C CONTAI NER, DEXTROSE
POTASSI UM CHLORI DE 40MEQ I N PLASTI C CONTAI NER, POTASSI UM CHLORI DE
POTASSI UM CHLORI DE 40MEQ I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, POTASSI UM
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 225%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 3%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE 5MEQ I N DEXTROSE 5%AND SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER,
POTASSI UM CHLORI DE, POTASSI UM CHLORI DE
PRECEDEX, DEXMEDETOMI DI NE HYDROCHLORI DE
PROCAI NAMI DE HYDROCHLORI DE, PROCAI NAMI DE HYDROCHLORI DE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
PROPOFOL, PROPOFOL
QUELI CI N PRESERVATI VE FREE, SUCCI NYLCHOLI NE CHLORI DE
QUELI CI N, SUCCI NYLCHOLI NE CHLORI DE
RI NGER' S I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
ROCURONI UM BROMI DE, ROCURONI UM BROMI DE
SODI UM ACETATE I N PLASTI C CONTAI NER, SODI UM ACETATE ANHYDROUS
SODI UM BI CARBONATE, SODI UM BI CARBONATE
SODI UM CHLORI DE 0. 45%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM LACTATE I N PLASTI C CONTAI NER, SODI UM LACTATE
SODI UM PHOSPHATES I N PLASTI C CONTAI NER, SODI UM PHOSPHATE, DI BASI C, HEPTAHYDRATE
SORBI TOL- MANNI TOL I N PLASTI C CONTAI NER, MANNI TOL
STERI LE WATER FOR I NJ ECTI ON I N PLASTI C CONTAI NER, STERI LE WATER FOR I NJ ECTI ON
STERI LE WATER I N PLASTI C CONTAI NER, STERI LE WATER FOR I RRI GATI ON
SUFENTANI L CI TRATE, SUFENTANI L CI TRATE
TALWI N, PENTAZOCI NE LACTATE
TAZI CEF, CEFTAZI DI ME
THAM, TROMETHAMI NE
TOBRAMYCI N SULFATE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, TOBRAMYCI N SULFATE
TOBRAMYCI N SULFATE, TOBRAMYCI N SULFATE
TPN ELECTROLYTES I N PLASTI C CONTAI NER, CALCI UM CHLORI DE
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
VECURONI UM BROMI DE, VECURONI UM BROMI DE
VERAPAMI L HYDROCHLORI DE, VERAPAMI L HYDROCHLORI DE
VI NORELBI NE TARTRATE, VI NORELBI NE TARTRATE
VI TAMI N K1, PHYTONADI ONE
ZI NC CHLORI DE I N PLASTI C CONTAI NER, ZI NC CHLORI DE
* HOSPI RA WORLDWI DE, I NC
DOBUTAMI NE HYDROCHLORI DE, DOBUTAMI NE HYDROCHLORI DE
FLUDARABI NE PHOSPHATE, FLUDARABI NE PHOSPHATE
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
MI TOXANTRONE HYDROCHLORI DE, MI TOXANTRONE HYDROCHLORI DE
NI TROPRESS, SODI UM NI TROPRUSSI DE
TOBRAMYCI N SULFATE, TOBRAMYCI N SULFATE
VI NCRI STI NE SULFATE PFS, VI NCRI STI NE SULFATE
HOSPI RA I NC
* HOSPI RA I NC
A- METHAPRED, METHYLPREDNI SOLONE SODI UM SUCCI NATE
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
AMPI CI LLI N AND SULBACTAM, AMPI CI LLI N SODI UM
ATRACURI UM BESYLATE PRESERVATI VE FREE, ATRACURI UM BESYLATE
ATRACURI UM BESYLATE, ATRACURI UM BESYLATE
CEFAZOLI N SODI UM, CEFAZOLI N SODI UM
CEFEPI ME HYDROCHLORI DE, CEFEPI ME HYDROCHLORI DE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 67
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * H * *
* HOSPI RA I NC
CEFOTAXI ME SODI UM, CEFOTAXI ME SODI UM
CEFOXI TI N, CEFOXI TI N SODI UM
CEFTRI AXONE, CEFTRI AXONE SODI UM
CEFUROXI ME SODI UM, CEFUROXI ME SODI UM
DOCETAXEL, DOCETAXEL
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
HEPARI N SODI UM, HEPARI N SODI UM
HYDROMORPHONE HYDROCHLORI DE, HYDROMORPHONE HYDROCHLORI DE
I MI PENEM AND CI LASTATI N, CI LASTATI N SODI UM
LEVETI RACETAM, LEVETI RACETAM
MAXI PI ME, CEFEPI ME HYDROCHLORI DE
MEPI VACAI NE HYDROCHLORI DE, MEPI VACAI NE HYDROCHLORI DE
MEROPENEM, MEROPENEM
MORPHI NE SULFATE, MORPHI NE SULFATE
NI PENT, PENTOSTATI N
OXALI PLATI N, OXALI PLATI N
PI PERACI LLI N AND TAZOBACTAM, PI PERACI LLI N SODI UM
THEOPHYLLI NE I N DEXTROSE 5%I N PLASTI C CONTAI NER, THEOPHYLLI NE
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
HOSPI RA WORLDWI DE
* HOSPI RA WORLDWI DE PTY
OXALI PLATI N, OXALI PLATI N
HOUSTON CYCLOTRON
* HOUSTON CYCLOTRON PARTNERS LP
AMMONI A N 13, AMMONI A N- 13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F- 18
SODI UM FLUORI DE F- 18, SODI UM FLUORI DE F- 18
HQ SPCLT PHARMA
* HQ SPECI ALTY PHARMA CORP
CI SPLATI N, CI SPLATI N
TAXOL, PACLI TAXEL
HQ SPECI ALI TY PHARMA
* HQ SPECI ALI TY PHARMA LLC
LEVETI RACETAM I N SODI UM CHLORI DE, LEVETI RACETAM
HQ SPECLT PHARMA
* HQ SPECI ALTY PHARMA
VUMON, TENI POSI DE
HRA PHARMA
* HRA PHARMA LLC
METOPI RONE, METYRAPONE
HYPERI ON THERAP I NC
* HYPERI ON THERAPEUTI CS I NC
RAVI CTI , GLYCEROL PHENYLBUTYRATE
HYPERI ON THERAPS I NC
* HYPERI ON THERAPEUTI CS I NC
BUPHENYL, SODI UM PHENYLBUTYRATE
ROCHE
* HOFFMANN LA ROCHE I NC
BONI VA, I BANDRONATE SODI UM
COPEGUS, RI BAVI RI N
FUZEON, ENFUVI RTI DE
KLONOPI N, CLONAZEPAM
TAMI FLU, OSELTAMI VI R PHOSPHATE
VALI UM, DI AZEPAM
* * I * *
I BI
* I STI TUTO BI OCHI MI CO I TALI ANO SPA
AMPI CI LLI N AND SULBACTAM, AMPI CI LLI N SODI UM
AMPI CI LLI N SODI UM, AMPI CI LLI N SODI UM
NAFCI LLI N SODI UM, NAFCI LLI N SODI UM


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 68
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * I * *
* I STI TUTO BI OCHI MI CO I TALI ANO SPA
PENI CI LLI N G POTASSI UM, PENI CI LLI N G POTASSI UM
PI PERACI LLI N AND TAZOBACTAM, PI PERACI LLI N SODI UM
PI PERACI LLI N, PI PERACI LLI N SODI UM
I DENTI PHARMS I NC
* I DENTI PHARMACEUTI CALS I NC
FLUOCI NOLONE ACETONI DE, FLUOCI NOLONE ACETONI DE
I GI LABS I NC
* I GI LABORATORI ES I NC
ECONAZOLE NI TRATE, ECONAZOLE NI TRATE
I MPAX LABS
* I MPAX LABORATORI ES I NC
ACARBOSE, ACARBOSE
ALPRAZOLAM, ALPRAZOLAM
ANAGRELI DE HYDROCHLORI DE, ANAGRELI DE HYDROCHLORI DE
BACLOFEN, BACLOFEN
BENZPHETAMI NE HYDROCHLORI DE, BENZPHETAMI NE HYDROCHLORI DE
BETHANECHOL CHLORI DE, BETHANECHOL CHLORI DE
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
CARBI DOPA AND LEVODOPA, CARBI DOPA
CHLOROQUI NE PHOSPHATE, CHLOROQUI NE PHOSPHATE
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
COLESTI POL HYDROCHLORI DE, COLESTI POL HYDROCHLORI DE
DANTROLENE SODI UM, DANTROLENE SODI UM
DEMECLOCYCLI NE HYDROCHLORI DE, DEMECLOCYCLI NE HYDROCHLORI DE
DI GOXI N, DI GOXI N
DI PYRI DAMOLE, DI PYRI DAMOLE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
FENOFI BRATE ( MI CRONI ZED) , FENOFI BRATE
FENOFI BRATE, FENOFI BRATE
FLUDROCORTI SONE ACETATE, FLUDROCORTI SONE ACETATE
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
LETROZOLE, LETROZOLE
LORATADI NE AND PSEUDOEPHEDRI NE SULFATE, LORATADI NE ( OTC)
LORATADI NE, LORATADI NE ( OTC)
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
METHYLTESTOSTERONE, METHYLTESTOSTERONE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
NADOLOL AND BENDROFLUMETHI AZI DE, BENDROFLUMETHI AZI DE
OMEPRAZOLE, OMEPRAZOLE
OXYMORPHONE HYDROCHLORI DE, OXYMORPHONE HYDROCHLORI DE
PENTOXI FYLLI NE, PENTOXI FYLLI NE
PI LOCARPI NE HYDROCHLORI DE, PI LOCARPI NE HYDROCHLORI DE
PRI MI DONE, PRI MI DONE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
PYRI DOSTI GMI NE BROMI DE, PYRI DOSTI GMI NE BROMI DE
RI LUZOLE, RI LUZOLE
RI MANTADI NE HYDROCHLORI DE, RI MANTADI NE HYDROCHLORI DE
TAMSULOSI N HYDROCHLORI DE, TAMSULOSI N HYDROCHLORI DE
TERBUTALI NE SULFATE, TERBUTALI NE SULFATE
TETRACYCLI NE HYDROCHLORI DE, TETRACYCLI NE HYDROCHLORI DE
I MPAX LABS I NC
* I MPAX LABORATORI ES I NC
CABERGOLI NE, CABERGOLI NE
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
DOXYCYCLI NE, DOXYCYCLI NE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
I MPAX PHARMS
* I MPAX PHARMACEUTI CALS
FEXOFENADI NE HYDROCHLORI DE AND PSEUDOEPHEDRI NE HYDROCHLORI DE, FEXOFENADI NE
FLAVOXATE HYDROCHLORI DE, FLAVOXATE HYDROCHLORI DE
GEMFI BROZI L, GEMFI BROZI L
MI DODRI NE HYDROCHLORI DE, MI DODRI NE HYDROCHLORI DE
ORPHENADRI NE CI TRATE, ORPHENADRI NE CI TRATE
OXYBUTYNI N CHLORI DE, OXYBUTYNI N CHLORI DE








34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 69
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * I * *
* I MPAX PHARMACEUTI CALS
SOTALOL HYDROCHLORI DE, SOTALOL HYDROCHLORI DE
I NCYTE CORP
* I NCYTE CORP
J AKAFI , RUXOLI TI NI B PHOSPHATE
I NDI CUS PHARMA
* I NDI CUS PHARMA LLC
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
LETROZOLE, LETROZOLE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
I NDOCO REMEDI ES
* I NDOCO REMEDI ES LTD
GLI MEPI RI DE, GLI MEPI RI DE
I NJ ECTALI A
* I NJ ECTALI A SRL
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
I NNOPHARMA LI CENSI NG
* I NNOPHARMA LI CENSI NG LLC
ACETYLCYSTEI NE, ACETYLCYSTEI NE
I NO
* I NO THERAPEUTI CS I NC
I NOMAX, NI TRI C OXI DE
I NSI GHT PHARMS
* I NSI GHT PHARMACEUTI CALS CORP
MONI STAT 1 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MONI STAT 3 COMBI NATI ON PACK ( PREFI LLED) , MI CONAZOLE NI TRATE ( OTC)
MONI STAT 3 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MONI STAT 3, MI CONAZOLE NI TRATE
MONI STAT 3, MI CONAZOLE NI TRATE ( OTC)
MONI STAT 7 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MONI STAT 7, MI CONAZOLE NI TRATE ( OTC)
MONI STAT- 3 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
NI X, PERMETHRI N ( OTC)
I NST BI OCHEM
* I NSTI TUT BI OCHEMI QUE SA
FLECTOR, DI CLOFENAC EPOLAMI NE
I NST BI OCHI MI QUE
* I NSTI TUTE BI OCHI MI QUE SA ( I BSA)
TI ROSI NT, LEVOTHYROXI NE SODI UM
I NSTI TUT BI OCHI MI QUE
* I NSTI TUT BI OCHI MI QUE SA I BSA
TI ROSI NT, LEVOTHYROXI NE SODI UM
I NSYS THERAP
* I NSYS THERAPEUTI CS I NC
DRONABI NOL, DRONABI NOL
SUBSYS, FENTANYL
I NTELLI PHARMACEUTI CS
* I NTELLI PHARMACEUTI CS CORP
DEXMETHYLPHENI DATE HYDROCHLORI DE, DEXMETHYLPHENI DATE HYDROCHLORI DE
I NTERGEL PHARM
* I NTERGEL PHARMACEUTI CAL I NC
NI FEDI PI NE, NI FEDI PI NE
I NTL MEDI CATED
* I NTERNATI ONAL MEDI CATED SYSTEMS LTD
MI LRI NONE LACTATE, MI LRI NONE LACTATE
I NTL MEDI CATI ON
* I NTERNATI ONAL MEDI CATI ON SYSTEM
DI PHENHYDRAMI NE HYDROCHLORI DE PRESERVATI VE FREE, DI PHENHYDRAMI NE HYDROCHLORI DE
LARYNG- O- J ET KI T, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE PRESERVATI VE FREE, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE, LI DOCAI NE HYDROCHLORI DE
MANNI TOL 25%, MANNI TOL
MEPERI DI NE HYDROCHLORI DE PRESERVATI VE FREE, MEPERI DI NE HYDROCHLORI DE
NALOXONE HYDROCHLORI DE, NALOXONE HYDROCHLORI DE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 70
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * I * *
* I NTERNATI ONAL MEDI CATI ON SYSTEM
PHYTONADI ONE, PHYTONADI ONE
POTASSI UM CHLORI DE, POTASSI UM CHLORI DE
PROCAI NAMI DE HYDROCHLORI DE, PROCAI NAMI DE HYDROCHLORI DE
* I NTERNATI ONAL MEDI CATI ON SYSTEMS LTD
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
I NTL MEDI CATI ON SYS
* I NTERNATI ONAL MEDI CATI ON SYSTEMS LTD
LORAZEPAM, LORAZEPAM
I NVAGEN PHARMS
* I NVAGEN PHARMACEUTI CALS I NC
ALFUZOSI N HYDROCHLORI DE, ALFUZOSI N HYDROCHLORI DE
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
BENZTROPI NE MESYLATE, BENZTROPI NE MESYLATE
CALCI UM ACETATE, CALCI UM ACETATE
CARBI NOXAMI NE MALEATE, CARBI NOXAMI NE MALEATE
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
FOLI C ACI D, FOLI C ACI D
FOSI NOPRI L SODI UM AND HYDROCHLOROTHI AZI DE, FOSI NOPRI L SODI UM
FOSI NOPRI L SODI UM, FOSI NOPRI L SODI UM
GABAPENTI N, GABAPENTI N
GEMFI BROZI L, GEMFI BROZI L
GLI MEPI RI DE, GLI MEPI RI DE
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
LEVETI RACETAM, LEVETI RACETAM
LI SI NOPRI L, LI SI NOPRI L
MEPROBAMATE, MEPROBAMATE
NABUMETONE, NABUMETONE
NAPROXEN, NAPROXEN
ORPHENADRI NE CI TRATE, ORPHENADRI NE CI TRATE
QUI NAPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
QUI NAPRI L HYDROCHLORI DE, QUI NAPRI L HYDROCHLORI DE
RAMI PRI L, RAMI PRI L
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
TOPI RAMATE, TOPI RAMATE
TRANDOLAPRI L, TRANDOLAPRI L
WARFARI N SODI UM, WARFARI N SODI UM
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
ZONI SAMI DE, ZONI SAMI DE
I NVENTI A HLTHCARE
* I NVENTI A HEALTHCARE PRI VATE LTD
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
I PCA LABS LTD
* I PCA LABORATORI ES LTD
ALLOPURI NOL, ALLOPURI NOL
ATENOLOL, ATENOLOL
CHLOROQUI NE PHOSPHATE, CHLOROQUI NE PHOSPHATE
FUROSEMI DE, FUROSEMI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
HYDROXYCHLOROQUI NE SULFATE, HYDROXYCHLOROQUI NE SULFATE
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
WARFARI N SODI UM, WARFARI N SODI UM
I PR
* I PR PHARMACEUTI CALS I NC
ATENOLOL AND CHLORTHALI DONE, ATENOLOL


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 71
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * I * *
* I PR PHARMACEUTI CALS I NC
ATENOLOL, ATENOLOL
CRESTOR, ROSUVASTATI N CALCI UM
ZOMI G, ZOLMI TRI PTAN
I PR PHARMS I NC
* I PR PHARMACEUTI CALS I NC
CAPRELSA, VANDETANI B
I PSEN I NC
* I PSEN BI OPHARMACEUTI CALS I NC
I NCRELEX, MECASERMI N RECOMBI NANT
I PSEN PHARMA
* I PSEN PHARMA BI OTECH SAS
SOMATULI NE DEPOT, LANREOTI DE ACETATE
I ROKO PHARMS
* I ROKO PHARMACEUTI CALS LLC
I NDOCI N, I NDOMETHACI N
I ROKO PHARMS LLC
* I ROKO PHARMACEUTI CALS LLC
ZORVOLEX, DI CLOFENAC
I SO TEX
* I SO TEX DI AGNOSTI CS I NC
J EANATOPE, ALBUMI N I ODI NATED I - 125 SERUM
MEGATOPE, ALBUMI N I ODI NATED I - 131 SERUM
I SOTEX
* I SOTEX DI AGNOSTI CS
GLOFI L- 125, I OTHALAMATE SODI UM I - 125
I STA PHARMS I NC
* I STA PHARMACEUTI CALS I NC
BEPREVE, BEPOTASTI NE BESI LATE
BROMDAY, BROMFENAC SODI UM
I STI TUTO BI O I TA SPA
* I STI TUTO BI OCHI MI CO I TALI ANO SPA
AMPI CI LLI N SODI UM, AMPI CI LLI N SODI UM
I VAX I NTL
* I VAX I NTERNATI ONAL GMBH
AMRI X, CYCLOBENZAPRI NE HYDROCHLORI DE
SYNRI BO, OMACETAXI NE MEPESUCCI NATE
I VAX PHARMS
* I VAX PHARMACEUTI CALS I NC
PERI NDOPRI L ERBUMI NE, PERI NDOPRI L ERBUMI NE
I VAX SUB TEVA PHARMS
* I VAX PHARMACEUTI CALS I NC SUB TEVA PHARMACEUTI CALS USA
ANAGRELI DE HYDROCHLORI DE, ANAGRELI DE HYDROCHLORI DE
BACLOFEN, BACLOFEN
BENAZEPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, BENAZEPRI L HYDROCHLORI DE
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
BUMETANI DE, BUMETANI DE
CABERGOLI NE, CABERGOLI NE
CETI RI ZI NE HYDROCHLORI DE AND PSEUDOEPHEDRI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CI METI DI NE, CI METI DI NE
CI METI DI NE, CI METI DI NE ( OTC)
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
CLOZAPI NE, CLOZAPI NE
CYCLOSPORI NE, CYCLOSPORI NE
CYPROHEPTADI NE HYDROCHLORI DE, CYPROHEPTADI NE HYDROCHLORI DE
DI AZEPAM, DI AZEPAM
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
FAMOTI DI NE, FAMOTI DI NE
FAMOTI DI NE, FAMOTI DI NE ( OTC)
FLUCONAZOLE, FLUCONAZOLE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FLUTAMI DE, FLUTAMI DE
FUROSEMI DE, FUROSEMI DE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 72
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * I * *
* I VAX PHARMACEUTI CALS I NC SUB TEVA PHARMACEUTI CALS USA
GABAPENTI N, GABAPENTI N
GLI PI ZI DE, GLI PI ZI DE
GLYBURI DE AND METFORMI N HYDROCHLORI DE, GLYBURI DE
GRI SEOFULVI N, GRI SEOFULVI N, MI CROSI ZE
GUANABENZ ACETATE, GUANABENZ ACETATE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I NDAPAMI DE, I NDAPAMI DE
I NDOMETHACI N, I NDOMETHACI N
LABETALOL HYDROCHLORI DE, LABETALOL HYDROCHLORI DE
LI SI NOPRI L AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LI SI NOPRI L, LI SI NOPRI L
LORAZEPAM, LORAZEPAM
METHYLDOPA, METHYLDOPA
MI SOPROSTOL, MI SOPROSTOL
NADOLOL, NADOLOL
NI COTI NE POLACRI LEX, NI COTI NE POLACRI LEX ( OTC)
NI TROFURANTOI N, NI TROFURANTOI N, MACROCRYSTALLI NE
OXAPROZI N, OXAPROZI N
OXAZEPAM, OXAZEPAM
PRAZOSI N HYDROCHLORI DE, PRAZOSI N HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
SI MVASTATI N, SI MVASTATI N
TERAZOSI N HYDROCHLORI DE, TERAZOSI N HYDROCHLORI DE
TETRACYCLI NE HYDROCHLORI DE, TETRACYCLI NE HYDROCHLORI DE
TRI AMTERENE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
VERAPAMI L HYDROCHLORI DE, VERAPAMI L HYDROCHLORI DE
* * J * *
J ACOBUS
* J ACOBUS PHARMACEUTI CAL CO
DAPSONE, DAPSONE
PASER, AMI NOSALI CYLI C ACI D
J ANSSEN BI OTECH
* J ANSSEN BI OTECH I NC
ZYTI GA, ABI RATERONE ACETATE
J ANSSEN PHARMS
* J ANSSEN PHARMACEUTI CALS I NC
AXERT, ALMOTRI PTAN MALATE
CONCERTA, METHYLPHENI DATE HYDROCHLORI DE
DI TROPAN XL, OXYBUTYNI N CHLORI DE
DURAGESI C- 100, FENTANYL
DURAGESI C- 12, FENTANYL
DURAGESI C- 25, FENTANYL
DURAGESI C- 50, FENTANYL
DURAGESI C- 75, FENTANYL
ELMI RON, PENTOSAN POLYSULFATE SODI UM
HALDOL, HALOPERI DOL DECANOATE
HALDOL, HALOPERI DOL LACTATE
I NVEGA SUSTENNA, PALI PERI DONE PALMI TATE
I NVEGA, PALI PERI DONE
I NVOKANA, CANAGLI FLOZI N
LEVAQUI N I N DEXTROSE 5%I N PLASTI C CONTAI NER, LEVOFLOXACI N
LEVAQUI N, LEVOFLOXACI N
MI CRONOR, NORETHI NDRONE
MODI CON 28, ETHI NYL ESTRADI OL
NI ZORAL, KETOCONAZOLE
NUCYNTA ER, TAPENTADOL HYDROCHLORI DE
NUCYNTA, TAPENTADOL HYDROCHLORI DE
ORTHO CYCLEN- 28, ETHI NYL ESTRADI OL
ORTHO EVRA, ETHI NYL ESTRADI OL
ORTHO TRI - CYCLEN LO, ETHI NYL ESTRADI OL
ORTHO TRI - CYCLEN, ETHI NYL ESTRADI OL
ORTHO- CEPT, DESOGESTREL
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 73
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * J * *
* J ANSSEN PHARMACEUTI CALS I NC
ORTHO- NOVUM 1/ 35- 28, ETHI NYL ESTRADI OL
ORTHO- NOVUM 7/ 7/ 7- 28, ETHI NYL ESTRADI OL
PANCREAZE, PANCRELI PASE ( AMYLASE
RAZADYNE ER, GALANTAMI NE HYDROBROMI DE
RAZADYNE, GALANTAMI NE HYDROBROMI DE
RI SPERDAL CONSTA, RI SPERI DONE
RI SPERDAL, RI SPERI DONE
SPORANOX, I TRACONAZOLE
TERAZOL 3, TERCONAZOLE
TERAZOL 7, TERCONAZOLE
TOPAMAX, TOPI RAMATE
TYLENOL W/ CODEI NE NO. 3, ACETAMI NOPHEN
TYLENOL W/ CODEI NE NO. 4, ACETAMI NOPHEN
TYLOX, ACETAMI NOPHEN
ULTRACET, ACETAMI NOPHEN
ULTRAM, TRAMADOL HYDROCHLORI DE
XARELTO, RI VAROXABAN
J ANSSEN PRODS
* J ANSSEN PRODUCTS LP
EDURANT, RI LPI VI RI NE HYDROCHLORI DE
PREZI STA, DARUNAVI R ETHANOLATE
J ANSSEN R AND D
* J ANSSEN RESEARCH AND DEVELOPMENT LLC
I NTELENCE, ETRAVI RI NE
PARAFON FORTE DSC, CHLORZOXAZONE
J ANSSEN RES AND DEV
* J ANSSEN RESEARCH AND DEVELOPMENT LLC
DOXI L ( LI POSOMAL) , DOXORUBI CI N HYDROCHLORI DE
OLYSI O, SI MEPREVI R
J ANSSEN THERAP
* J ANSSEN THERAPEUTI CS DI V J ANSSEN PRODUCTS LP
SI RTURO, BEDAQUI LI NE FUMARATE
J AZZ PHARMS
* J AZZ PHARMACEUTI CALS I NC
LUVOX CR, FLUVOXAMI NE MALEATE
XYREM, SODI UM OXYBATE
J AZZ PHARMS I I I
* J AZZ PHARMACEUTI CALS I I I I NTERNATI ONAL LTD
FAZACLO ODT, CLOZAPI NE
* J AZZ PHARMACEUTI CALS I NTERNATI ONAL I I I
VERSACLOZ, CLOZAPI NE
J AZZ PHARMS I NTL
* J AZZ PHARMACEUTI CALS I NTERNATI ONAL LTD
PRI ALT, ZI CONOTI DE ACETATE
J HP PHARMS
* J HP PHARMACEUTI CALS LLC
ADRENALI N, EPI NEPHRI NE
BREVI TAL SODI UM, METHOHEXI TAL SODI UM
COLY- MYCI N M, COLI STI METHATE SODI UM
COLY- MYCI N S, COLI STI N SULFATE
DANTRI UM, DANTROLENE SODI UM
DELESTROGEN, ESTRADI OL VALERATE
KETALAR, KETAMI NE HYDROCHLORI DE
PI TOCI N, OXYTOCI N
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TI GAN, TRI METHOBENZAMI DE HYDROCHLORI DE
TRI OSTAT, LI OTHYRONI NE SODI UM
J HP PHARMS LLC
* J HP PHARMACEUTI CALS LLC
ADRENALI N, EPI NEPHRI NE
ETOMI DATE, ETOMI DATE
J I ANGSU HANSOH PHARM
* J I ANGSU HANSOH PHARMACEUTI CAL CO LTD







34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 74
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * J * *
* J I ANGSU HANSOH PHARMACEUTI CAL CO LTD
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
VI NORELBI NE TARTRATE, VI NORELBI NE TARTRATE
J I ANGSU HENGRUI MED
* J I ANGSU HENGRUI MEDI CI NE CO LTD
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
LETROZOLE, LETROZOLE
J OHNSON AND J OHNSON
* J OHNSON AND J OHNSON GROUP CONSUMER COMPANI ES
MEN' S ROGAI NE, MI NOXI DI L ( OTC)
ROGAI NE ( FOR MEN) , MI NOXI DI L ( OTC)
ROGAI NE ( FOR WOMEN) , MI NOXI DI L ( OTC)
ROGAI NE EXTRA STRENGTH ( FOR MEN) , MI NOXI DI L ( OTC)
VI SI NE- A, NAPHAZOLI NE HYDROCHLORI DE ( OTC)
* J OHNSON AND J OHNSON HEALTHCARE PRODUCTS
VI SI NE L. R. , OXYMETAZOLI NE HYDROCHLORI DE ( OTC)
J UBI LANT CADI STA
* J UBI LANT CADI STA PHARMACEUTI CALS I NC
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
FOLI C ACI D, FOLI C ACI D
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
MECLI ZI NE HYDROCHLORI DE, MECLI ZI NE HYDROCHLORI DE
METHYLPREDNI SOLONE, METHYLPREDNI SOLONE
PREDNI SONE, PREDNI SONE
PROCOMP, PROCHLORPERAZI NE MALEATE
TERAZOSI N HYDROCHLORI DE, TERAZOSI N HYDROCHLORI DE
J UBI LANT DRAXI MAGE
* J UBI LANT DRAXI MAGE I NC
AN- DTPA, TECHNETI UM TC- 99M PENTETATE KI T
DRAXI MAGE MDP- 25, TECHNETI UM TC- 99M MEDRONATE
HI CON, SODI UM I ODI DE I - 131
PULMOLI TE, TECHNETI UM TC- 99M ALBUMI N AGGREGATED KI T
SODI UM I ODI DE I - 131, SODI UM I ODI DE I - 131
J UBI LANT LI FE
* J UBI LANT LI FE SCI ENCES LTD
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
LAMOTRI GI NE, LAMOTRI GI NE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
J UBI LANT ORGANOSYS
* J UBI LANT ORGANOSYS LTD
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
OLANZAPI NE, OLANZAPI NE
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
RI SPERI DONE, RI SPERI DONE
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
STEVENS J
* J EROME STEVENS PHARMACEUTI CALS I NC
BUTALBI TAL, ASPI RI N, CAFFEI NE, AND CODEI NE PHOSPHATE, ASPI RI N
CEPHALEXI N, CEPHALEXI N
DI GOXI N, DI GOXI N
METHOCARBAMOL AND ASPI RI N, ASPI RI N
ORPHENADRI NE CI TRATE, ASPI RI N, AND CAFFEI NE, ASPI RI N
UNI THROI D, LEVOTHYROXI NE SODI UM **
* * K * *
GRI FFEN
* KWGRI FFEN CO
BI OSCRUB, CHLORHEXI DI NE GLUCONATE ( OTC)
KI NG PFI ZER
* KI NG PHARMACEUTI CALS I NC SUB PFI ZER I NC
AVI NZA, MORPHI NE SULFATE
KI NG PHARMS
* KI NG PHARMACEUTI CALS I NC

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 75
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * K * *
* KI NG PHARMACEUTI CALS I NC
ALTACE, RAMI PRI L
BI CI LLI N C- R 900/ 300, PENI CI LLI N G BENZATHI NE
BI CI LLI N C- R, PENI CI LLI N G BENZATHI NE
BI CI LLI N L- A, PENI CI LLI N G BENZATHI NE
CORGARD, NADOLOL
CORZI DE, BENDROFLUMETHI AZI DE
PENI CI LLI N G PROCAI NE, PENI CI LLI N G PROCAI NE
SI LVADENE, SI LVER SULFADI AZI NE
SKELAXI N, METAXALONE
SYNERCI D, DALFOPRI STI N
TI GAN, TRI METHOBENZAMI DE HYDROCHLORI DE
* KI NG PHARMACEUTI CALS RESEARCH AND DEVELOPMENT I NC SUB KI NG PHARMACEUTI CALS I NC
TAPAZOLE, METHI MAZOLE
TUSSI GON, HOMATROPI NE METHYLBROMI DE
KI NG PHARMS R AND D
* KI NG PHARMACEUTI CALS RESEARCH AND DEVELOPMENT I NC
CYTOMEL, LI OTHYRONI NE SODI UM
LEVOXYL, LEVOTHYROXI NE SODI UM **
* KI NG PHARMACEUTI CALS RESEARCH DEVELOPMENT I NC
OXECTA, OXYCODONE HYDROCHLORI DE
KOWA CO
* KOWA CO LTD
LI VALO, PI TAVASTATI N CALCI UM
KREI TCHMAN PET CTR
* KREI TCHMAN PET CENTER
AMMONI A N 13, AMMONI A N- 13
KREMERS URBAN DEV
* KREMERS URBAN DEVELOPMENT CO
RABEPRAZOLE SODI UM, RABEPRAZOLE SODI UM
KREMERS URBAN PHARMS
* KREMERS URBAN PHARMACEUTI CALS I NC
GLYCOLAX, POLYETHYLENE GLYCOL 3350
GLYCOLAX, POLYETHYLENE GLYCOL 3350 ( OTC)
I SOSORBI DE MONONI TRATE, I SOSORBI DE MONONI TRATE
MONOKET, I SOSORBI DE MONONI TRATE
NI TROGLYCERI N, NI TROGLYCERI N
OMEPRAZOLE, OMEPRAZOLE
KRKA TOVARNA ZDRAVI L
* KRKA TOVARNA ZDRAVI L DD NOVO MESTO
LANSOPRAZOLE , LANSOPRAZOLE
KUDCO I RELAND
* KUDCO I RELAND LTD
ATORVASTATI N CALCI UM, ATORVASTATI N CALCI UM
LETROZOLE, LETROZOLE
METHYLPHENI DATE HYDROCHLORI DE, METHYLPHENI DATE HYDROCHLORI DE
MONTELUKAST SODI UM, MONTELUKAST SODI UM
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
KV PHARM
* KV PHARMACEUTI CAL CO
CLI NDESSE, CLI NDAMYCI N PHOSPHATE
EVAMI ST, ESTRADI OL
MAKENA, HYDROXYPROGESTERONE CAPROATE
KVK TECH
* KVK TECH I NC
BENZPHETAMI NE HYDROCHLORI DE, BENZPHETAMI NE HYDROCHLORI DE
BETAXOLOL HYDROCHLORI DE, BETAXOLOL HYDROCHLORI DE
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
KALEXATE, SODI UM POLYSTYRENE SULFONATE
PHENDI METRAZI NE TARTRATE, PHENDI METRAZI NE TARTRATE
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
* * L * *
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 76
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * L * *
LAB HRA PHARMA
* LABORATOI RE HRA PHARMA
ELLA, ULI PRI STAL ACETATE
LANDELA PHARM
* LANDELA PHARMACEUTI CAL
ALBUTEROL SULFATE, ALBUTEROL SULFATE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
I PRATROPI UM BROMI DE, I PRATROPI UM BROMI DE
LANNETT
* LANNETT CO I NC
ACETAZOLAMI DE, ACETAZOLAMI DE
DI CYCLOMI NE HYDROCHLORI DE, DI CYCLOMI NE HYDROCHLORI DE
DI PHENOXYLATE HYDROCHLORI DE AND ATROPI NE SULFATE, ATROPI NE SULFATE
LANI AZI D, I SONI AZI D
LANORI NAL, ASPI RI N
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
PRI MI DONE, PRI MI DONE
PROBALAN, PROBENECI D
* LANNETT HOLDI NGS I NC
BACLOFEN, BACLOFEN
BETHANECHOL CHLORI DE, BETHANECHOL CHLORI DE
CLI NDAMYCI N HYDROCHLORI DE, CLI NDAMYCI N HYDROCHLORI DE
DANAZOL, DANAZOL
DI PYRI DAMOLE, DI PYRI DAMOLE
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
DOXYCYCLI NE, DOXYCYCLI NE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FLUPHENAZI NE HYDROCHLORI DE, FLUPHENAZI NE HYDROCHLORI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
HYDROMORPHONE HYDROCHLORI DE, HYDROMORPHONE HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
PI LOCARPI NE HYDROCHLORI DE, PI LOCARPI NE HYDROCHLORI DE
RI FAMPI N, RI FAMPI N
TERBUTALI NE SULFATE, TERBUTALI NE SULFATE
URSODI OL, URSODI OL
LANNETT HOLDI NGS I NC
* LANNETT HOLDI NGS I NC
BUTALBI TAL, ACETAMI NOPHEN AND CAFFEI NE, ACETAMI NOPHEN
DI ETHYLPROPI ON HYDROCHLORI DE, DI ETHYLPROPI ON HYDROCHLORI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOXAPI NE SUCCI NATE, LOXAPI NE SUCCI NATE
METHOCARBAMOL, METHOCARBAMOL
MORPHI NE SULFATE, MORPHI NE SULFATE
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
PHENTERMI NE RESI N COMPLEX, PHENTERMI NE RESI N COMPLEX
TRI AMTERENE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LANTHEUS MEDCL
* LANTHEUS MEDI CAL I MAGI NG I NC
ABLAVAR, GADOFOSVESET TRI SODI UM
CARDI OLI TE, TECHNETI UM TC- 99M SESTAMI BI KI T
DEFI NI TY, PERFLUTREN
GALLI UM CI TRATE GA 67, GALLI UM CI TRATE GA- 67
NEUROLI TE, TECHNETI UM TC- 99M BI CI SATE KI T
TECHNELI TE, TECHNETI UM TC- 99M SODI UM PERTECHNETATE GENERATOR
THALLOUS CHLORI DE TL 201, THALLOUS CHLORI DE TL- 201
XENON XE 133, XENON XE- 133
LANTHEUS MEDI CAL
* LANTHEUS MEDI CAL I MAGI NG I NC
QUADRAMET, SAMARI UM SM- 153 LEXI DRONAM PENTASODI UM
LARKEN LABS
* LARKEN LABORATORI ES I NC
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
LAVI PHARM LABS
* LAVI PHARM LABORATORI ES I NC







34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 77
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * L * *
* LAVI PHARM LABORATORI ES I NC
FENTANYL- 100, FENTANYL
FENTANYL- 25, FENTANYL
FENTANYL- 50, FENTANYL
FENTANYL- 75, FENTANYL
LEHI GH VALLEY
* LEHI GH VALLEY TECHNOLOGI ES I NC
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
LEK PHARMS
* LEK PHARMACEUTI CALS D D
BROMOCRI PTI NE MESYLATE, BROMOCRI PTI NE MESYLATE
LEK PHARMS DD
* LEK PHARMACEUTI CALS DD
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
LEO PHARM
* LEO PHARMACEUTI CAL PRODUCTS LTD
DOVONEX, CALCI POTRI ENE
LEO PHARMA AS
* LEO PHARMA AS
DOVONEX, CALCI POTRI ENE
PI CATO, I NGENOL MEBUTATE
TACLONEX, BETAMETHASONE DI PROPI ONATE
LG LI FE
* LG LI FE SCI ENCES LTD
VALTROPI N, SOMATROPI N RECOMBI NANT
LG LI FE SCI ENCES
* LG LI FE SCI ENCES LTD
FACTI VE, GEMI FLOXACI N MESYLATE
LI AONI NG CHENGDA
* LI AONI NG CHENGDA BI OTECHNOLOGY CO LTD
ZI DOVUDI NE, ZI DOVUDI NE
LLOYD
* LLOYD I NC
LEVOTHROI D, LEVOTHYROXI NE SODI UM **
LNK
* LNK I NTERNATI ONAL I NC
DOXYLAMI NE SUCCI NATE, DOXYLAMI NE SUCCI NATE ( OTC)
I BUPROFEN, I BUPROFEN ( OTC)
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE ( OTC)
LOREAL USA
* LOREAL USA PRODUCTS I NC
ANTHELI OS 20, AVOBENZONE ( OTC)
ANTHELI OS 40, AVOBENZONE ( OTC)
ANTHELI OS SX, AVOBENZONE ( OTC)
CAPI TAL SOLEI L 15, AVOBENZONE ( OTC)
LOTUS PHARM CO LTD
* LOTUS PHARMACEUTI CAL CO LTD
LEVETI RACETAM, LEVETI RACETAM
LUI TPOLD
* LUI TPOLD PHARMACEUTI CALS I NC
ACETYLCYSTEI NE, ACETYLCYSTEI NE
ADENOSI NE, ADENOSI NE
AMI NOCAPROI C ACI D, AMI NOCAPROI C ACI D
AMI NOPHYLLI NE, AMI NOPHYLLI NE
BENZTROPI NE MESYLATE, BENZTROPI NE MESYLATE
BETAMETHASONE ACETATE AND BETAMETHASONE SODI UM PHOSPHATE, BETAMETHASONE ACETATE
BROMFENAC SODI UM, BROMFENAC SODI UM
BUPRENORPHI NE HYDROCHLORI DE, BUPRENORPHI NE HYDROCHLORI DE
CAFFEI NE CI TRATE, CAFFEI NE CI TRATE
CALCI TRI OL, CALCI TRI OL
CHLOROTHI AZI DE SODI UM, CHLOROTHI AZI DE SODI UM
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
CYANOCOBALAMI N, CYANOCOBALAMI N
CYCLOSPORI NE, CYCLOSPORI NE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 78
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * L * *
* LUI TPOLD PHARMACEUTI CALS I NC
DACTI NOMYCI N, DACTI NOMYCI N
DEXAMETHASONE SODI UM PHOSPHATE,
DEXFERRUM, I RON DEXTRAN
DEXAMETHASONE SODI UM PHOSPHATE
DOPAMI NE HYDROCHLORI DE, DOPAMI NE HYDROCHLORI DE
DORZOLAMI DE HYDROCHLORI DE, DORZOLAMI DE HYDROCHLORI DE
DROPERI DOL, DROPERI DOL
EPI NASTI NE HYDROCHLORI DE, EPI NASTI NE HYDROCHLORI DE
ESTRADI OL VALERATE, ESTRADI OL VALERATE
ETOMI DATE, ETOMI DATE
FOMEPI ZOLE, FOMEPI ZOLE
FOSPHENYTOI N SODI UM, FOSPHENYTOI N SODI UM
FUROSEMI DE, FUROSEMI DE
GANCI CLOVI R, GANCI CLOVI R SODI UM
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
I BUTI LI DE FUMARATE, I BUTI LI DE FUMARATE
I NJ ECTAFER, FERRI C CARBOXYMALTOSE
LATANOPROST, LATANOPROST
LEVETI RACETAM, LEVETI RACETAM
LEVOCARNI TI NE, LEVOCARNI TI NE
LI DOCAI NE HYDROCHLORI DE, LI DOCAI NE HYDROCHLORI DE
MANNI TOL 25%, MANNI TOL
METHYLDOPATE HYDROCHLORI DE, METHYLDOPATE HYDROCHLORI DE
METHYLERGONOVI NE MALEATE, METHYLERGONOVI NE MALEATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
NEOMYCI N AND POLYMYXI N B SULFATES AND GRAMI CI DI N, GRAMI CI DI N
NEOMYCI N AND POLYMYXI N B SULFATES AND HYDROCORTI SONE, HYDROCORTI SONE
NI TROGLYCERI N, NI TROGLYCERI N
OLANZAPI NE, OLANZAPI NE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
PHENYTOI N SODI UM, PHENYTOI N SODI UM
PROGESTERONE, PROGESTERONE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
SPRI X, KETOROLAC TROMETHAMI NE
TORSEMI DE, TORSEMI DE
TRANEXAMI C ACI D, TRANEXAMI C ACI D
TRI METHOBENZAMI DE HYDROCHLORI DE PRESERVATI VE FREE, TRI METHOBENZAMI DE HYDROCHLORI DE
TRI METHOBENZAMI DE HYDROCHLORI DE, TRI METHOBENZAMI DE HYDROCHLORI DE
VENOFER, I RON SUCROSE
ZI DOVUDI NE, ZI DOVUDI NE
LUKARE MEDI CAL LLC
* LUKARE MEDI CAL LLC
ELLI OTTS B SOLUTI ON, CALCI UM CHLORI DE
LUNDBECK LLC
* LUNDBECK LLC
ONFI , CLOBAZAM
SABRI L, VI GABATRI N
LUPI N
* LUPI N LTD
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
CARVEDI LOL, CARVEDI LOL
CEFADROXI L, CEFADROXI L/ CEFADROXI L HEMI HYDRATE
CEFDI NI R, CEFDI NI R
CEFOTAXI ME SODI UM, CEFOTAXI ME SODI UM
CEFPROZI L, CEFPROZI L
CEFTRI AXONE, CEFTRI AXONE SODI UM
CEFUROXI ME AXETI L, CEFUROXI ME AXETI L
CEPHALEXI N, CEPHALEXI N
DI VALPROEX SODI UM, DI VALPROEX SODI UM

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 79
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * L * *
* LUPI N LTD
ETHAMBUTOL HYDROCHLORI DE, ETHAMBUTOL HYDROCHLORI DE
LEVETI RACETAM, LEVETI RACETAM
LEVOFLOXACI N, LEVOFLOXACI N
LI SI NOPRI L AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LI SI NOPRI L, LI SI NOPRI L
LOVASTATI N, LOVASTATI N
QUI NAPRI L HYDROCHLORI DE, QUI NAPRI L HYDROCHLORI DE
RAMI PRI L, RAMI PRI L
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SI MVASTATI N, SI MVASTATI N
TOPI RAMATE, TOPI RAMATE
TRANDOLAPRI L, TRANDOLAPRI L
LUPI N ATLANTI S
* LUPI N ATLANTI S HOLDI NGS SA
ANTARA ( MI CRONI ZED) , FENOFI BRATE
LUPI N LTD
* LUPI N LI MI TED
LEVETI RACETAM, LEVETI RACETAM
LEVONORGESTREL AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
* LUPI N LTD
ABACAVI R SULFATE, LAMI VUDI NE AND ZI DOVUDI NE, ABACAVI R SULFATE
DAYSEE, ETHI NYL ESTRADI OL
DOXYCYCLI NE, DOXYCYCLI NE
DROSPI RENONE AND ETHI NYL ESTRADI OL, DROSPI RENONE
DULOXETI NE HYDROCHLORI DE, DULOXETI NE HYDROCHLORI DE
ENSKYCE, DESOGESTREL
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
FAMOTI DI NE, FAMOTI DI NE
FENOFI BRATE, FENOFI BRATE
FENOFI BRI C ACI D, CHOLI NE FENOFI BRATE
GATI FLOXACI N, GATI FLOXACI N
I MI PRAMI NE HYDROCHLORI DE, I MI PRAMI NE HYDROCHLORI DE
I MI PRAMI NE PAMOATE, I MI PRAMI NE PAMOATE
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I RBESARTAN, I RBESARTAN
J ENCYCLA, NORETHI NDRONE
KURVELO, ETHI NYL ESTRADI OL
LAMI VUDI NE AND ZI DOVUDI NE, LAMI VUDI NE
LAMOTRI GI NE, LAMOTRI GI NE
LEVETI RACETAM, LEVETI RACETAM
LEVONORGESTREL AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL ( OTC)
LORAZEPAM, LORAZEPAM
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
MEFENAMI C ACI D, MEFENAMI C ACI D
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
NABUMETONE, NABUMETONE
NORETHI NDRONE, NORETHI NDRONE
PERI NDOPRI L ERBUMI NE, PERI NDOPRI L ERBUMI NE
PI RMELLA 1/ 35, ETHI NYL ESTRADI OL
PI RMELLA 7/ 7/ 7, ETHI NYL ESTRADI OL
PREGABALI N, PREGABALI N
QUETI API NE FUMARATE, QUETI API NE FUMARATE
RABEPRAZOLE SODI UM, RABEPRAZOLE SODI UM
RANOLAZI NE, RANOLAZI NE
SUPRAX, CEFI XI ME
TELMI SARTAN AND AMLODI PI NE, AMLODI PI NE BESYLATE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
VALSARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
VYFEMLA, ETHI NYL ESTRADI OL
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE



















34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 80
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * L * *
LUPI N PHARMS
* LUPI N PHARMACEUTI CALS I NC
AMLODI PI NE BESYLATE AND BENAZEPRI L HYDROCHLORI DE, AMLODI PI NE BESYLATE
DESLORATADI NE, DESLORATADI NE
MELOXI CAM, MELOXI CAM
NORGESTI MATE AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM
RI FAMPI N, RI FAMPI N
SUPRAX, CEFI XI ME
ZI PRASI DONE HYDROCHLORI DE, ZI PRASI DONE HYDROCHLORI DE
LYNE
* LYNE LABORATORI ES I NC
CHLORHEXI DI NE GLUCONATE, CHLORHEXI DI NE GLUCONATE
CLI NDAMYCI N PALMI TATE HYDROCHLORI DE, CLI NDAMYCI N PALMI TATE HYDROCHLORI DE
CYPROHEPTADI NE HYDROCHLORI DE, CYPROHEPTADI NE HYDROCHLORI DE
DEXAMETHASONE, DEXAMETHASONE
HYDROCORTI SONE, HYDROCORTI SONE
LEVOCARNI TI NE, LEVOCARNI TI NE
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
LYNROSE LABS
* LYNROSE LABS LLC
CARBI NOXAMI NE MALEATE, CARBI NOXAMI NE MALEATE
PERRI GO
* L PERRI GO CO
ACETAMI NOPHEN, ACETAMI NOPHEN ( OTC)
ACETAMI NOPHEN, ASPI RI N AND CAFFEI NE, ACETAMI NOPHEN ( OTC)
CHI LDREN' S I BUPROFEN, I BUPROFEN ( OTC)
CROMOLYN SODI UM, CROMOLYN SODI UM ( OTC)
DOXYLAMI NE SUCCI NATE, DOXYLAMI NE SUCCI NATE ( OTC)
FAMOTI DI NE, FAMOTI DI NE ( OTC)
I BUPROFEN AND PSEUDOEPHEDRI NE HYDROCHLORI DE, I BUPROFEN ( OTC)
I BUPROFEN, I BUPROFEN ( OTC)
LOPERAMI DE HYDROCHLORI DE AND SI METHI CONE, LOPERAMI DE HYDROCHLORI DE ( OTC)
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE ( OTC)
LORATADI NE, LORATADI NE ( OTC)
MI CONAZOLE 3 COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MI CONAZOLE NI TRATE, MI CONAZOLE NI TRATE ( OTC)
MI NOXI DI L EXTRA STRENGTH ( FOR MEN) , MI NOXI DI L ( OTC)
NAPROXEN SODI UM AND PSEUDOEPHEDRI NE HYDROCHLORI DE, NAPROXEN SODI UM ( OTC)
NAPROXEN SODI UM, NAPROXEN SODI UM ( OTC)
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
TAB- PROFEN, I BUPROFEN ( OTC)
TI OCONAZOLE, TI OCONAZOLE ( OTC)
* * M * *
MACLEODS PHARMS LTD
* MACLEODS PHARMACEUTI CALS LTD
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
FAMCI CLOVI R, FAMCI CLOVI R
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I RBESARTAN, I RBESARTAN
LEVOFLOXACI N, LEVOFLOXACI N
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
SI LDENAFI L CI TRATE, SI LDENAFI L CI TRATE
VALSARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
MALLI NCKRODT
* MALLI NCKRODT CHEMI CAL I NC
ANEXSI A 7. 5/ 650, ACETAMI NOPHEN
ANEXSI A, ACETAMI NOPHEN
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 81
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
* MALLI NCKRODT CHEMI CAL I NC
BUTALBI TAL, ACETAMI NOPHEN AND CAFFEI NE, ACETAMI NOPHEN
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
METHADONE HYDROCHLORI DE, METHADONE HYDROCHLORI DE
METHADOSE, METHADONE HYDROCHLORI DE
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
* MALLI NCKRODT I NC
ANEXSI A 5/ 325, ACETAMI NOPHEN
ANEXSI A 7. 5/ 325, ACETAMI NOPHEN
ANEXSI A, ACETAMI NOPHEN
DEXTROAMPHETAMI NE SULFATE, DEXTROAMPHETAMI NE SULFATE
FENTANYL CI TRATE, FENTANYL CI TRATE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
HYDROMORPHONE HYDROCHLORI DE, HYDROMORPHONE HYDROCHLORI DE
MEPERI DI NE HYDROCHLORI DE, MEPERI DI NE HYDROCHLORI DE
METHADONE HYDROCHLORI DE, METHADONE HYDROCHLORI DE
METHYLI N, METHYLPHENI DATE HYDROCHLORI DE
METHYLPHENI DATE HYDROCHLORI DE, METHYLPHENI DATE HYDROCHLORI DE
MORPHI NE SULFATE, MORPHI NE SULFATE
NALTREXONE HYDROCHLORI DE, NALTREXONE HYDROCHLORI DE
OPTI MARK I N PLASTI C CONTAI NER, GADOVERSETAMI DE
OPTI MARK, GADOVERSETAMI DE
OXYCET, ACETAMI NOPHEN
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
PENNSAI D, DI CLOFENAC SODI UM
SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
TECHNETI UM TC- 99 SESTAMI BI , TECHNETI UM TC- 99M SESTAMI BI KI T
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
* MALLI NCKRODT MEDI CAL I NC
CONRAY 30, I OTHALAMATE MEGLUMI NE
CONRAY 43, I OTHALAMATE MEGLUMI NE
CONRAY, I OTHALAMATE MEGLUMI NE
CYSTO- CONRAY I I , I OTHALAMATE MEGLUMI NE
GALLI UM CI TRATE GA 67, GALLI UM CI TRATE GA- 67
I NDI UM I N 111 CHLORI DE, I NDI UM I N- 111 CHLORI DE
MD- 76R, DI ATRI ZOATE MEGLUMI NE
MD- GASTROVI EW, DI ATRI ZOATE MEGLUMI NE
OCTREOSCAN, I NDI UM I N- 111 PENTETREOTI DE KI T
OPTI RAY 240, I OVERSOL
OPTI RAY 300, I OVERSOL
OPTI RAY 320, I OVERSOL
OPTI RAY 350, I OVERSOL
SODI UM I ODI DE I 123, SODI UM I ODI DE I - 123
SODI UM I ODI DE I 131, SODI UM I ODI DE I - 131
TECHNESCAN MAG3, TECHNETI UM TC- 99M MERTI ATI DE KI T
TECHNESCAN PYP KI T, TECHNETI UM TC- 99M PYROPHOSPHATE KI T
TECHNESCAN, TECHNETI UM TC- 99M OXI DRONATE KI T
THALLOUS CHLORI DE TL 201, THALLOUS CHLORI DE TL- 201
ULTRA- TECHNEKOWFM, TECHNETI UM TC- 99M SODI UM PERTECHNETATE GENERATOR
ULTRATAG, TECHNETI UM TC- 99M RED BLOOD CELL KI T
MALLI NCKRODT I NC
* MALLI NCKRODT I NC
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
BENZPHETAMI NE HYDROCHLORI DE, BENZPHETAMI NE HYDROCHLORI DE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMI NE
EXALGO, HYDROMORPHONE HYDROCHLORI DE
FENTANYL- 100, FENTANYL
FENTANYL- 25, FENTANYL
FENTANYL- 50, FENTANYL
FENTANYL- 75, FENTANYL
GABLOFEN, BACLOFEN
HYDROMORPHONE HYDROCHLORI DE, HYDROMORPHONE HYDROCHLORI DE
METHADONE HYDROCHLORI DE, METHADONE HYDROCHLORI DE
METHYLI N ER, METHYLPHENI DATE HYDROCHLORI DE






















34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 82
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
* MALLI NCKRODT I NC
METHYLPHENI DATE HYDROCHLORI DE, METHYLPHENI DATE HYDROCHLORI DE
MORPHI NE SULFATE, MORPHI NE SULFATE
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
OXYMORPHONE HYDROCHLORI DE, OXYMORPHONE HYDROCHLORI DE
RESTORI L, TEMAZEPAM
ROXI CODONE, OXYCODONE HYDROCHLORI DE
TOFRANI L, I MI PRAMI NE HYDROCHLORI DE
TOFRANI L- PM, I MI PRAMI NE PAMOATE
MALLI NCKRODT LLC
* MALLI NCKRODT LLC
ANAFRANI L, CLOMI PRAMI NE HYDROCHLORI DE
PAMELOR, NORTRI PTYLI NE HYDROCHLORI DE
MARATHON PHARMS
* MARATHON PHARMACEUTI CALS LLC
PEPCI D, FAMOTI DI NE
SECONAL SODI UM, SECOBARBI TAL SODI UM
MARATHON PHARMS LLC
* MARATHON PHARMACEUTI CALS LLC
I PRI VASK, DESI RUDI N RECOMBI NANT
MARKSANS PHARMA
* MARKSANS PHARMA LTD
GABAPENTI N, GABAPENTI N
I BUPROFEN, I BUPROFEN
I BUPROFEN, I BUPROFEN ( OTC)
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
NAPROXEN SODI UM, NAPROXEN SODI UM ( OTC)
NAPROXEN, NAPROXEN
MARSAM PHARMS LLC
* MARSAM PHARMACEUTI CALS LLC
TOBRAMYCI N SULFATE, TOBRAMYCI N SULFATE
MATRI X LABS LTD
* MATRI X LABORATORI ES LTD
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
NI FEDI PI NE, NI FEDI PI NE
STAVUDI NE, STAVUDI NE
MAYNE PHARMA
* MAYNE PHARMA I NTERNATI ONAL PTY LTD
DORYX, DOXYCYCLI NE HYCLATE
ERYC, ERYTHROMYCI N
MCNEI L
* MCNEI L CONSUMER PRODUCTS CO DI V MCNEI LAB I NC
CHI LDREN' S MOTRI N, I BUPROFEN ( OTC)
I BUPROFEN, I BUPROFEN ( OTC)
I MODI UM A- D EZ CHEWS, LOPERAMI DE HYDROCHLORI DE ( OTC)
I MODI UM MULTI - SYMPTOM RELI EF, LOPERAMI DE HYDROCHLORI DE ( OTC)
MOTRI N I B, I BUPROFEN ( OTC)
MOTRI N MI GRAI NE PAI N, I BUPROFEN ( OTC)
ZYRTEC- D 12 HOUR, CETI RI ZI NE HYDROCHLORI DE ( OTC)
MCNEI L CONS
* MCNEI L CONSUMER HEALTHCARE
CHI LDREN' S MOTRI N COLD, I BUPROFEN ( OTC)
CHI LDREN' S MOTRI N, I BUPROFEN ( OTC)
I MODI UM A- D, LOPERAMI DE HYDROCHLORI DE ( OTC)
I MODI UM MULTI - SYMPTOM RELI EF, LOPERAMI DE HYDROCHLORI DE ( OTC)
I MODI UM, LOPERAMI DE HYDROCHLORI DE
J UNI OR STRENGTH MOTRI N, I BUPROFEN ( OTC)
NI ZORAL A- D, KETOCONAZOLE ( OTC)
PEPCI D AC , FAMOTI DI NE ( OTC)
PEPCI D AC, FAMOTI DI NE ( OTC)
PEPCI D COMPLETE, CALCI UM CARBONATE ( OTC)
SI NE- AI D I B, I BUPROFEN ( OTC)
SUDAFED 12 HOUR, PSEUDOEPHEDRI NE HYDROCHLORI DE ( OTC)
SUDAFED 24 HOUR, PSEUDOEPHEDRI NE HYDROCHLORI DE ( OTC)
TYLENOL , ACETAMI NOPHEN ( OTC)




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 83
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
MCNEI L CONSUMER
* MCNEI L CONSUMER HEALTHCARE DI V MCNEI L PPC I NC
CHI LDREN' S ZYRTEC ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S ZYRTEC HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
ZYRTEC ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
ZYRTEC HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
ZYRTEC, CETI RI ZI NE HYDROCHLORI DE
MCPRF
* MAYO CLI NI C PET RADI OCHEMI STRY FACI LI TY
AMMONI A N 13, AMMONI A N- 13
CHOLI NE C- 11, CHOLI NE C- 11
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F- 18
SODI UM FLUORI DE F- 18, SODI UM FLUORI DE F- 18
MEDA PHARMS
* MEDA PHARMACEUTI CALS
DYMI STA, AZELASTI NE HYDROCHLORI DE
EDLUAR, ZOLPI DEM TARTRATE
* MEDA PHARMACEUTI CALS I NC
ANADROL- 50, OXYMETHOLONE
ASTELI N, AZELASTI NE HYDROCHLORI DE
ASTEPRO, AZELASTI NE HYDROCHLORI DE
AVC, SULFANI LAMI DE
BUTI SOL SODI UM, BUTABARBI TAL SODI UM
CESAMET, NABI LONE
COLYTE WI TH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
COLYTE, POLYETHYLENE GLYCOL 3350
CORTI FOAM, HYDROCORTI SONE ACETATE
DEMADEX, TORSEMI DE
DEPEN, PENI CI LLAMI NE
DI PENTUM, OLSALAZI NE SODI UM
ELESTRI N, ESTRADI OL
EPI FOAM, HYDROCORTI SONE ACETATE
FELBATOL, FELBAMATE
GASTROCROM, CROMOLYN SODI UM
LUFYLLI N, DYPHYLLI NE
MUSE, ALPROSTADI L
OPTI VAR, AZELASTI NE HYDROCHLORI DE
PROCTOFOAM HC, HYDROCORTI SONE ACETATE
ROWASA, MESALAMI NE
SFROWASA, MESALAMI NE
TRI LYTE, POLYETHYLENE GLYCOL 3350
* MEDA PHARMACEUTI CALS MEDA PHARMACEUTI CALS I NC
SOMA COMPOUND W/ CODEI NE, ASPI RI N
SOMA COMPOUND, ASPI RI N
SOMA, CARI SOPRODOL
MEDEFI L I NC
* MEDEFI L I NC
SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
SODI UM CHLORI DE 0. 9%, SODI UM CHLORI DE
MEDI CI S
* MEDI CI S PHARMACEUTI CAL CORP
ALDARA, I MI QUI MOD
CALCI UM DI SODI UM VERSENATE, EDETATE CALCI UM DI SODI UM
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
DYNACI N, MI NOCYCLI NE HYDROCHLORI DE
ESTRASORB, ESTRADI OL HEMI HYDRATE
LOPROX, CI CLOPI ROX
LUZU, LULI CONAZOLE
MAXAI R, PI RBUTEROL ACETATE
METROGEL- VAGI NAL, METRONI DAZOLE
MI NI TRAN, NI TROGLYCERI N
NORFLEX, ORPHENADRI NE CI TRATE
NORGESI C FORTE, ASPI RI N
NORGESI C, ASPI RI N
SOLODYN, MI NOCYCLI NE HYDROCHLORI DE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 84
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
* MEDI CI S PHARMACEUTI CAL CORP
SYNACORT, HYDROCORTI SONE
THEOLAI R, THEOPHYLLI NE
VANOS, FLUOCI NONI DE
ZI ANA, CLI NDAMYCI N PHOSPHATE
ZYCLARA, I MI QUI MOD
MEDI CURE
* MEDI CURE I NTERNATI ONAL I NC
AGGRASTAT, TI ROFI BAN HYDROCHLORI DE
MEDI GENE AG
* MEDI GENE AG
VEREGEN, SI NECATECHI NS
MEDI METRI KS PHARMS
* MEDI METRI KS PHARMACEUTI CALS I NC
LOPROX, CI CLOPI ROX
SYNALAR, FLUOCI NOLONE ACETONI DE
MEDI MMUNE
* MEDI MMUNE
ETHYOL, AMI FOSTI NE
MEDTECH PRODS
* MEDTECH PRODUCTS I NC
TAGAMET HB, CI METI DI NE ( OTC)
MEDTRONI C NEURO
* MEDTRONI C NEUROMODULATI ON
LI ORESAL, BACLOFEN
MERCK
* MERCK AND CO I NC
AMI NOHI PPURATE SODI UM, AMI NOHI PPURATE SODI UM
CANCI DAS, CASPOFUNGI N ACETATE
EMEND, APREPI TANT
FOSAMAX PLUS D, ALENDRONATE SODI UM
FOSAMAX, ALENDRONATE SODI UM
MAXALT, RI ZATRI PTAN BENZOATE
MAXALT- MLT, RI ZATRI PTAN BENZOATE
PRI MAXI N, CI LASTATI N SODI UM
PROSCAR, FI NASTERI DE
SI NGULAI R, MONTELUKAST SODI UM
ZOLI NZA, VORI NOSTAT
* MERCK RESEARCH LABORATORI ES DI V MERCK CO I NC
CLI NORI L, SULI NDAC
NOROXI N, NORFLOXACI N
PRI NI VI L, LI SI NOPRI L
PRI NZI DE, HYDROCHLOROTHI AZI DE
PROPECI A, FI NASTERI DE
SI NGULAI R, MONTELUKAST SODI UM
TRUSOPT, DORZOLAMI DE HYDROCHLORI DE
ZOCOR, SI MVASTATI N
MERCK AND CO I NC
* MERCK AND CO I NC
EMEND, FOSAPREPI TANT DI MEGLUMI NE
FOSAMAX, ALENDRONATE SODI UM
MERCK SANTE SAS
* MERCK SANTE SAS
CYANOKI T, HYDROXOCOBALAMI N
MERCK SHARP DOHME
* MERCK SHARP AND DOHME CORP
CELESTONE SOLUSPAN, BETAMETHASONE ACETATE
CLARI NEX D 24 HOUR, DESLORATADI NE
CLARI NEX, DESLORATADI NE
CLARI NEX- D 12 HOUR, DESLORATADI NE
COZAAR, LOSARTAN POTASSI UM
CRI XI VAN, I NDI NAVI R SULFATE
DI PROLENE AF, BETAMETHASONE DI PROPI ONATE
DI PROLENE, BETAMETHASONE DI PROPI ONATE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 85
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
* MERCK SHARP AND DOHME CORP
DULERA, FORMOTEROL FUMARATE
ELOCON, MOMETASONE FUROATE
GUANI DI NE HYDROCHLORI DE, GUANI DI NE HYDROCHLORI DE
HYZAAR, HYDROCHLOROTHI AZI DE
I NVANZ, ERTAPENEM SODI UM
I SENTRESS, RALTEGRAVI R POTASSI UM
J ANUMET XR, METFORMI N HYDROCHLORI DE
J ANUMET, METFORMI N HYDROCHLORI DE
J ANUVI A, SI TAGLI PTI N PHOSPHATE
LI PTRUZET, ATORVASTATI N CALCI UM
LOTRI SONE, BETAMETHASONE DI PROPI ONATE
NI TRO- DUR, NI TROGLYCERI N
NOXAFI L, POSACONAZOLE
REBETOL, RI BAVI RI N
SI NEMET CR, CARBI DOPA
SI NEMET, CARBI DOPA
STROMECTOL, I VERMECTI N
TEMODAR, TEMOZOLOMI DE
VI CTRELI S, BOCEPREVI R
ZI OPTAN, TAFLUPROST
MERI DI AN MEDCL
* MERI DI AN MEDI CAL TECHNOLOGI ES I NC
DUODOTE, ATROPI NE
* MERI DI AN MEDI CAL TECHNOLOGI ES I NC SUB KI NG PHARMACEUTI CALS I NC
ALSUMA, SUMATRI PTAN SUCCI NATE
MERI DI AN MEDCL TECHN
* MERI DI AN MEDI CAL TECHNOLOGI ES I NC
ATROPEN, ATROPI NE
LI DOPEN, LI DOCAI NE HYDROCHLORI DE
MORPHI NE SULFATE, MORPHI NE SULFATE
PRALI DOXI ME CHLORI DE, PRALI DOXI ME CHLORI DE
MERRO PHARM
* MERRO PHARMACEUTI CAL CO LTD
I BUPROFEN, I BUPROFEN ( OTC)
MERZ PHARMS
* MERZ PHARMACEUTI CALS LLC
CUVPOSA, GLYCOPYRROLATE
NAFTI N, NAFTI FI NE HYDROCHLORI DE
ONMEL, I TRACONAZOLE
METHAPHARM
* METHAPHARM I NC
LEVETI RACETAM, LEVETI RACETAM
PROVOCHOLI NE, METHACHOLI NE CHLORI DE
MI CRO LABS LTD
* MI CRO LABS LTD
MEFENAMI C ACI D, MEFENAMI C ACI D
NEVI RAPI NE, NEVI RAPI NE
SI MVASTATI N, SI MVASTATI N
MI CRO LABS LTD I NDI A
* MI CRO LABS LTD I NDI A
CROMOLYN SODI UM, CROMOLYN SODI UM
GLI MEPI RI DE, GLI MEPI RI DE
LEVOCETI RI ZI NE DI HYDROCHLORI DE, LEVOCETI RI ZI NE DI HYDROCHLORI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
TRAMADOL HYDROCHLORI DE AND ACETAMI NOPHEN, ACETAMI NOPHEN
MI KAH PHARMA
* MI KAH PHARMA LLC
DANTROLENE SODI UM, DANTROLENE SODI UM
I SRADI PI NE, I SRADI PI NE
LOXAPI NE SUCCI NATE, LOXAPI NE SUCCI NATE
PHENDI METRAZI NE TARTRATE, PHENDI METRAZI NE TARTRATE
TRI MI PRAMI NE MALEATE, TRI MI PRAMI NE MALEATE
MI KART
* MI KART I NC


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 86
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
* MI KART I NC
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
AMANTADI NE HYDROCHLORI DE, AMANTADI NE HYDROCHLORI DE
AMI NOCAPROI C ACI D, AMI NOCAPROI C ACI D
AMI NOCAPROI C, AMI NOCAPROI C ACI D
BENZONATATE, BENZONATATE
BENZPHETAMI NE HYDROCHLORI DE, BENZPHETAMI NE HYDROCHLORI DE
BUTALBI TAL, ACETAMI NOPHEN AND CAFFEI NE, ACETAMI NOPHEN
BUTAPAP, ACETAMI NOPHEN
CARBI NOXAMI NE MALEATE, CARBI NOXAMI NE MALEATE
CHLORZOXAZONE, CHLORZOXAZONE
DEXTROAMPHETAMI NE SULFATE, DEXTROAMPHETAMI NE SULFATE
DI CYCLOMI NE HYDROCHLORI DE, DI CYCLOMI NE HYDROCHLORI DE
ERGOTAMI NE TARTRATE AND CAFFEI NE, CAFFEI NE
ESGI C- PLUS, ACETAMI NOPHEN
ETHOSUXI MI DE, ETHOSUXI MI DE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
MEPERI DI NE HYDROCHLORI DE, MEPERI DI NE HYDROCHLORI DE
METHAZOLAMI DE, METHAZOLAMI DE
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
PHENDI METRAZI NE TARTRATE, PHENDI METRAZI NE TARTRATE
PYRAZI NAMI DE, PYRAZI NAMI DE
TRI HEXYPHENI DYL HYDROCHLORI DE, TRI HEXYPHENI DYL HYDROCHLORI DE
MI LLENNI UM PHARMS
* MI LLENNI UM PHARMACEUTI CALS I NC
VELCADE, BORTEZOMI B
MI RROR PHARMS
* MI RROR PHARMACEUTI CALS LLC
BUTALBI TAL, ACETAMI NOPHEN AND CAFFEI NE, ACETAMI NOPHEN
CARI SOPRODOL AND ASPI RI N, ASPI RI N
CARI SOPRODOL, ASPI RI N AND CODEI NE PHOSPHATE, ASPI RI N
CARI SOPRODOL, CARI SOPRODOL
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
PROBENECI D AND COLCHI CI NE, COLCHI CI NE
MI SSI ON PHARMA
* MI SSI ON PHARMACAL CO
BI NOSTO, ALENDRONATE SODI UM
LI THOSTAT, ACETOHYDROXAMI C ACI D
PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
TEXACORT, HYDROCORTI SONE
THI OLA, TI OPRONI N
TI NDAMAX, TI NI DAZOLE
UROCI T- K, POTASSI UM CI TRATE
MI ST PHARMS LLC
* MI ST PHARMACEUTI CALS LLC
NI TROMI ST, NI TROGLYCERI N
MN PHARMS
* MN PHARMACEUTI CALS
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
MOBI US THERAP
* MOBI US THERAPEUTI CS LLC
MI TOSOL, MI TOMYCI N
MOLNLYCKE HLTH
* MOLNLYCKE HEALTH CARE
HI BI CLENS, CHLORHEXI DI NE GLUCONATE ( OTC)
HI BI STAT, CHLORHEXI DI NE GLUCONATE ( OTC)
MONARCH PHARMS
* MONARCH PHARMACEUTI CALS I NC
CORTI SPORI N, BACI TRACI N ZI NC
CORTI SPORI N, HYDROCORTI SONE ACETATE
CORTI SPORI N, HYDROCORTI SONE
MENEST, ESTROGENS, ESTERI FI ED
NEOSPORI N G. U. I RRI GANT, NEOMYCI N SULFATE
NEOSPORI N, GRAMI CI DI N
PEDI OTI C, HYDROCORTI SONE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 87
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
* MONARCH PHARMACEUTI CALS I NC
SEPTRA DS, SULFAMETHOXAZOLE
SEPTRA, SULFAMETHOXAZOLE
VI ROPTI C, TRI FLURI DI NE
MORTON GROVE
* MORTON GROVE PHARMACEUTI CALS I NC
LACTULOSE, LACTULOSE
MORTON GROVE PHARMS
* MORTON GROVE PHARMACEUTI CALS I NC
GENERLAC,
MSD CONSUMER
LACTULOSE
* MSD CONSUMER CARE I NC
OXYTROL FOR WOMEN, OXYBUTYNI N
ZEGERI D OTC, OMEPRAZOLE ( OTC)
MSD I NTL
( OTC)
* MSD I NTERNATI ONAL GMBH
VYTORI N, EZETI MI BE
MSD I NTL GMBH
* MSD I NTERNATI ONAL GMBH
ZETI A, EZETI MI BE
MURTY PHARMS
* MURTY PHARMACEUTI CALS I NC
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
DI PYRI DAMOLE, DI PYRI DAMOLE
MUSTAFA NEVSAT
* MUSTAFA NEVSAT I LAC SANAYI I AS
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
METHYLPREDNI SOLONE SODI UM SUCCI NATE, METHYLPREDNI SOLONE SODI UM SUCCI NATE
MUSTAFA NEVZAT
* MUSTAFA NEVZAT I LAC SANAYI I AS
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
VECURONI UM BROMI DE, VECURONI UM BROMI DE
MUTUAL PHARM
* MUTUAL PHARMACEUTI CAL CO I NC
ACETAZOLAMI DE, ACETAZOLAMI DE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALLOPURI NOL, ALLOPURI NOL
AMI TRI PTYLI NE HYDROCHLORI DE, AMI TRI PTYLI NE HYDROCHLORI DE
ATENOLOL AND CHLORTHALI DONE, ATENOLOL
ATENOLOL, ATENOLOL
BACTRI M DS, SULFAMETHOXAZOLE
BACTRI M, SULFAMETHOXAZOLE
CARI SOPRODOL, CARI SOPRODOL
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMI NE
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
ERGOLOI D MESYLATES, ERGOLOI D MESYLATES
FELODI PI NE, FELODI PI NE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
I MI PRAMI NE HYDROCHLORI DE, I MI PRAMI NE HYDROCHLORI DE
LOVASTATI N, LOVASTATI N
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONI DAZOLE, METRONI DAZOLE
MI NOXI DI L, MI NOXI DI L
NYSTATI N, NYSTATI N
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
PI ROXI CAM, PI ROXI CAM
PREDNI SONE, PREDNI SONE
PRI MI DONE, PRI MI DONE
PROPAFENONE HYDROCHLORI DE, PROPAFENONE HYDROCHLORI DE
QUI NI DI NE GLUCONATE, QUI NI DI NE GLUCONATE
QUI NI DI NE SULFATE, QUI NI DI NE SULFATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 88
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
* MUTUAL PHARMACEUTI CAL CO I NC
SPI RONOLACTONE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
SPI RONOLACTONE, SPI RONOLACTONE
SULFAMETHOXAZOLE AND TRI METHOPRI M, SULFAMETHOXAZOLE
SULI NDAC, SULI NDAC
TEMAZEPAM, TEMAZEPAM
THI ORI DAZI NE HYDROCHLORI DE, THI ORI DAZI NE HYDROCHLORI DE
TOLMETI N SODI UM, TOLMETI N SODI UM
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
TRAZODONE HYDROCHLORI DE, TRAZODONE HYDROCHLORI DE
MUTUAL PHARM CO I NC
* MUTUAL PHARMACEUTI CAL CO I NC
FI BRI COR, FENOFI BRI C ACI D
I BANDRONATE SODI UM, I BANDRONATE SODI UM
LEVETI RACETAM, LEVETI RACETAM
QUALAQUI N, QUI NI NE SULFATE
MUTUAL PHARMA
* MUTUAL PHARMACAL CO
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
KETOCONAZOLE, KETOCONAZOLE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
TRI METHOBENZAMI DE HYDROCHLORI DE, TRI METHOBENZAMI DE HYDROCHLORI DE
MYLAN
* MYLAN LABORATORI ES I NC
ACYCLOVI R, ACYCLOVI R
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
ANAGRELI DE HYDROCHLORI DE, ANAGRELI DE HYDROCHLORI DE
CAPTOPRI L, CAPTOPRI L
ETODOLAC, ETODOLAC
OLANZAPI NE, OLANZAPI NE
TERAZOSI N HYDROCHLORI DE, TERAZOSI N HYDROCHLORI DE
* MYLAN PHARMACEUTI CALS
METOPROLOL TARTRATE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
* MYLAN PHARMACEUTI CALS I NC
ACARBOSE, ACARBOSE
ACEBUTOLOL HYDROCHLORI DE, ACEBUTOLOL HYDROCHLORI DE
ACYCLOVI R, ACYCLOVI R
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALENDRONATE SODI UM, ALENDRONATE SODI UM
ALFUZOSI N HYDROCHLORI DE, ALFUZOSI N HYDROCHLORI DE
ALLOPURI NOL, ALLOPURI NOL
ALPRAZOLAM, ALPRAZOLAM
AMI LORI DE HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, AMI LORI DE HYDROCHLORI DE
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
AMI TRI PTYLI NE HYDROCHLORI DE, AMI TRI PTYLI NE HYDROCHLORI DE
AMLODI PI NE BESYLATE AND BENAZEPRI L HYDROCHLORI DE, AMLODI PI NE BESYLATE
ANASTROZOLE, ANASTROZOLE
ATENOLOL AND CHLORTHALI DONE, ATENOLOL
ATENOLOL, ATENOLOL
AVI TA, TRETI NOI N
AZATHI OPRI NE, AZATHI OPRI NE
AZI THROMYCI N, AZI THROMYCI N
BACLOFEN, BACLOFEN
BALSALAZI DE DI SODI UM, BALSALAZI DE DI SODI UM
BENAZEPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, BENAZEPRI L HYDROCHLORI DE
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
BI CALUTAMI DE, BI CALUTAMI DE
BI SOPROLOL FUMARATE AND HYDROCHLOROTHI AZI DE, BI SOPROLOL FUMARATE
BI SOPROLOL FUMARATE, BI SOPROLOL FUMARATE
BROMOCRI PTI NE MESYLATE, BROMOCRI PTI NE MESYLATE
BUDESONI DE, BUDESONI DE
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
BUSPI RONE HYDROCHLORI DE, BUSPI RONE HYDROCHLORI DE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CAPTOPRI L AND HYDROCHLOROTHI AZI DE, CAPTOPRI L







34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
B - 89
* * M * *
* MYLAN PHARMACEUTI CALS I NC
CARBI DOPA AND LEVODOPA, CARBI DOPA
CARVEDI LOL, CARVEDI LOL
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE
CHLOROTHI AZI DE, CHLOROTHI AZI DE
CHLORPROPAMI DE, CHLORPROPAMI DE
CHLORTHALI DONE, CHLORTHALI DONE
CI LOSTAZOL, CI LOSTAZOL
CI METI DI NE, CI METI DI NE
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
CLARI THROMYCI N, CLARI THROMYCI N
CLOMI PRAMI NE HYDROCHLORI DE, CLOMI PRAMI NE HYDROCHLORI DE
CLONAZEPAM, CLONAZEPAM
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
CLORAZEPATE DI POTASSI UM, CLORAZEPATE DI POTASSI UM
CLORPRES, CHLORTHALI DONE
CLOZAPI NE, CLOZAPI NE
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
CYSTAGON, CYSTEAMI NE BI TARTRATE
DI AZEPAM, DI AZEPAM
DI CLOFENAC POTASSI UM, DI CLOFENAC POTASSI UM
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
DI CYCLOMI NE HYDROCHLORI DE, DI CYCLOMI NE HYDROCHLORI DE
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
DI PHENOXYLATE HYDROCHLORI DE AND ATROPI NE SULFATE, ATROPI NE SULFATE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
DOXAZOSI N MESYLATE, DOXAZOSI N MESYLATE
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
DOXYCYCLI NE, DOXYCYCLI NE
ENALAPRI L MALEATE AND HYDROCHLOROTHI AZI DE, ENALAPRI L MALEATE
ENALAPRI L MALEATE, ENALAPRI L MALEATE
ESTRADI OL, ESTRADI OL
ESTROPI PATE, ESTROPI PATE
ETI DRONATE DI SODI UM, ETI DRONATE DI SODI UM
ETOPOSI DE, ETOPOSI DE
EXTENDED PHENYTOI N SODI UM, PHENYTOI N SODI UM
FAMCI CLOVI R, FAMCI CLOVI R
FAMOTI DI NE, FAMOTI DI NE
FAMOTI DI NE, FAMOTI DI NE ( OTC)
FELODI PI NE, FELODI PI NE
FENOFI BRATE, FENOFI BRATE
FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
FEXOFENADI NE HYDROCHLORI DE, FEXOFENADI NE HYDROCHLORI DE
FI NASTERI DE, FI NASTERI DE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FLUPHENAZI NE HYDROCHLORI DE, FLUPHENAZI NE HYDROCHLORI DE
FLURBI PROFEN, FLURBI PROFEN
FLUTAMI DE, FLUTAMI DE
FLUVOXAMI NE MALEATE, FLUVOXAMI NE MALEATE
FUROSEMI DE, FUROSEMI DE
GABAPENTI N, GABAPENTI N
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
GLI MEPI RI DE, GLI MEPI RI DE
GLI PI ZI DE AND METFORMI N HYDROCHLORI DE, GLI PI ZI DE
GLI PI ZI DE, GLI PI ZI DE
GLYBURI DE ( MI CRONI ZED) , GLYBURI DE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
GUANFACI NE HYDROCHLORI DE, GUANFACI NE HYDROCHLORI DE
HALOPERI DOL, HALOPERI DOL
( OTC)
( OTC)


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 90
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
* MYLAN PHARMACEUTI CALS I NC
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
HYDROXYCHLOROQUI NE SULFATE, HYDROXYCHLOROQUI NE SULFATE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
I NDAPAMI DE, I NDAPAMI DE
I NDOMETHACI N, I NDOMETHACI N
KETOCONAZOLE, KETOCONAZOLE
KETOPROFEN, KETOPROFEN
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
LAMOTRI GI NE, LAMOTRI GI NE
LATANOPROST, LATANOPROST
LETROZOLE, LETROZOLE
LEVETI RACETAM, LEVETI RACETAM
LEVOFLOXACI N, LEVOFLOXACI N
LEVOTHYROXI NE SODI UM, LEVOTHYROXI NE SODI UM **
LI OTHYRONI NE SODI UM, LI OTHYRONI NE SODI UM
LI SI NOPRI L AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LI SI NOPRI L, LI SI NOPRI L
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE
LORATADI NE, LORATADI NE ( OTC)
LORAZEPAM, LORAZEPAM
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
LOVASTATI N, LOVASTATI N
LOXAPI NE SUCCI NATE, LOXAPI NE SUCCI NATE
MAPROTI LI NE HYDROCHLORI DE, MAPROTI LI NE HYDROCHLORI DE
MECLOFENAMATE SODI UM, MECLOFENAMATE SODI UM
MELOXI CAM, MELOXI CAM
MENTAX, BUTENAFI NE HYDROCHLORI DE
MENTAX- TC, BUTENAFI NE HYDROCHLORI DE
MERCAPTOPURI NE, MERCAPTOPURI NE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
METHI MAZOLE, METHI MAZOLE
METHOTREXATE SODI UM, METHOTREXATE SODI UM
METHYLDOPA AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
METHYLDOPA, METHYLDOPA
METOLAZONE, METOLAZONE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MI RTAZAPI NE, MI RTAZAPI NE
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
NADOLOL AND BENDROFLUMETHAZI DE, BENDROFLUMETHI AZI DE
NADOLOL, NADOLOL
NAPROXEN, NAPROXEN
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
NI FEDI PI NE, NI FEDI PI NE
NI SOLDI PI NE, NI SOLDI PI NE
NI TROFURANTOI N ( MONOHYDRATE/ MACROCRYSTALS) , NI TROFURANTOI N
NI TROFURANTOI N, NI TROFURANTOI N, MACROCRYSTALLI NE
NORTRI PTYLI NE HYDROCHLORI DE, NORTRI PTYLI NE HYDROCHLORI DE
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON, ONDANSETRON
OXYBUTYNI N CHLORI DE, OXYBUTYNI N CHLORI DE
PACLI TAXEL, PACLI TAXEL
PAROXETI NE HYDROCHLORI DE, PAROXETI NE HYDROCHLORI DE
PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
PEG- 3350; POTASSI UM CHLORI DE; SODI UM BI CARBONATE; SODI UM CHLORI DE, POLYETHYLENE GLYCOL
PENTOXI FYLLI NE, PENTOXI FYLLI NE
PERPHENAZI NE AND AMI TRI PTYLI NE HYDROCHLORI DE, AMI TRI PTYLI NE HYDROCHLORI DE
PHENYTEK, PHENYTOI N SODI UM
PI OGLI TAZONE HYDROCHLORI DE AND METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
PI ROXI CAM, PI ROXI CAM
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 ( OTC)
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 91
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
* MYLAN PHARMACEUTI CALS I NC
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM
PRAZOSI N HYDROCHLORI DE, PRAZOSI N HYDROCHLORI DE
PROBENECI D, PROBENECI D
PROCHLORPERAZI NE MALEATE, PROCHLORPERAZI NE MALEATE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
PROPRANOLOL HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
QUI NAPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
QUI NAPRI L HYDROCHLORI DE, QUI NAPRI L HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
RI SPERI DONE, RI SPERI DONE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
SELEGI LI NE HYDROCHLORI DE, SELEGI LI NE HYDROCHLORI DE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SOTALOL HYDROCHLORI DE, SOTALOL HYDROCHLORI DE
SPI RONOLACTONE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
SPI RONOLACTONE, SPI RONOLACTONE
STAVUDI NE, STAVUDI NE
SULI NDAC, SULI NDAC
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TACROLI MUS, TACROLI MUS
TAMOXI FEN CI TRATE, TAMOXI FEN CI TRATE
TAMSULOSI N HYDROCHLORI DE, TAMSULOSI N HYDROCHLORI DE
TEMAZEPAM, TEMAZEPAM
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
THI ORI DAZI NE HYDROCHLORI DE, THI ORI DAZI NE HYDROCHLORI DE
THI OTHI XENE, THI OTHI XENE
TI MOLOL MALEATE, TI MOLOL MALEATE
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
TOLMETI N SODI UM, TOLMETI N SODI UM
TOPI RAMATE, TOPI RAMATE
TRAMADOL HYDROCHLORI DE AND ACETAMI NOPHEN, ACETAMI NOPHEN
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
TRANDOLAPRI L, TRANDOLAPRI L
TRI AMTERENE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
TRI FLUOPERAZI NE HYDROCHLORI DE, TRI FLUOPERAZI NE HYDROCHLORI DE
URSODI OL, URSODI OL
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
VERAPAMI L HYDROCHLORI DE, VERAPAMI L HYDROCHLORI DE
WARFARI N SODI UM, WARFARI N SODI UM
ZALEPLON, ZALEPLON
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
ZONI SAMI DE, ZONI SAMI DE
MYLAN I NSTI TUTI ONAL
* MYLAN I NSTI TUTI ONAL I NC
SULFAMYLON, MAFENI DE ACETATE
* MYLAN I NSTI TUTI ONAL LLC
ALOPRI M, ALLOPURI NOL SODI UM
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
AMPI CI LLI N AND SULBACTAM, AMPI CI LLI N SODI UM
CARBOPLATI N, CARBOPLATI N
CI DOFOVI R, CI DOFOVI R
COSYNTROPI N, COSYNTROPI N
DEXRAZOXANE HYDROCHLORI DE, DEXRAZOXANE HYDROCHLORI DE
DI METHYL SULFOXI DE, DI METHYL SULFOXI DE
DI PHENHYDRAMI NE HYDROCHLORI DE, DI PHENHYDRAMI NE HYDROCHLORI DE
DOLOPHI NE HYDROCHLORI DE, METHADONE HYDROCHLORI DE
DURACLON, CLONI DI NE HYDROCHLORI DE
ENLON, EDROPHONI UM CHLORI DE
ENLON- PLUS, ATROPI NE SULFATE
ESMOLOL HYDROCHLORI DE, ESMOLOL HYDROCHLORI DE
FLUDARABI NE PHOSPHATE, FLUDARABI NE PHOSPHATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 92
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
* MYLAN I NSTI TUTI ONAL LLC
FOMEPI ZOLE, FOMEPI ZOLE
I BUTI LI DE FUMARATE, I BUTI LI DE FUMARATE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
I SOSULFAN BLUE, I SOSULFAN BLUE
KETAMI NE HYDROCHLORI DE, KETAMI NE HYDROCHLORI DE
MEFOXI N I N PLASTI C CONTAI NER, CEFOXI TI N SODI UM
MELPHALAN HYDROCHLORI DE, MELPHALAN HYDROCHLORI DE
MESNA, MESNA
MI TOXANTRONE HYDROCHLORI DE, MI TOXANTRONE HYDROCHLORI DE
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
OCTREOTI DE ACETATE ( PRESERVATI VE FREE) , OCTREOTI DE ACETATE
RI MSO- 50, DI METHYL SULFOXI DE
ROCURONI UM BROMI DE, ROCURONI UM BROMI DE
SOTRADECOL, SODI UM TETRADECYL SULFATE
TESTOSTERONE CYPI ONATE, TESTOSTERONE CYPI ONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
THI AMI NE HYDROCHLORI DE, THI AMI NE HYDROCHLORI DE
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
TRANEXAMI C ACI D, TRANEXAMI C ACI D
ULTI VA, REMI FENTANI L HYDROCHLORI DE
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
MYLAN LABS
* MYLAN LABORATORI ES LTD
CANDESARTAN CI LEXETI L AND HYDROCHLOROTHI AZI DE, CANDESARTAN CI LEXETI L
NEVI RAPI NE, NEVI RAPI NE
MYLAN PHARMS I NC
* MYLAN PHARMACEUTI CALS I NC
ABACAVI R SULFATE, ABACAVI R SULFATE
ACYCLOVI R, ACYCLOVI R
ALPRAZOLAM, ALPRAZOLAM
AMLODI PI NE BESYLATE AND ATORVASTATI N CALCI UM, AMLODI PI NE BESYLATE
AMNESTEEM, I SOTRETI NOI N
ANAGRELI DE HYDROCHLORI DE, ANAGRELI DE HYDROCHLORI DE
ARMODAFI NI L, ARMODAFI NI L
ATORVASTATI N CALCI UM, ATORVASTATI N CALCI UM
AVI TA, TRETI NOI N
BACLOFEN, BACLOFEN
CABERGOLI NE, CABERGOLI NE
CHLORDI AZEPOXI DE AND AMI TRI PTYLI NE HYDROCHLORI DE, AMI TRI PTYLI NE HYDROCHLORI DE
CI LOSTAZOL, CI LOSTAZOL
CI PROFLOXACI N EXTENDED RELEASE, CI PROFLOXACI N
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
CLI NDAMYCI N HYDROCHLORI DE, CLI NDAMYCI N HYDROCHLORI DE
CLI NDAMYCI N PHOSPHATE AND BENZOYL PEROXI DE, BENZOYL PEROXI DE
CLONAZEPAM, CLONAZEPAM
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
DESLORATADI NE, DESLORATADI NE
DEXMETHYLPHENI DATE HYDROCHLORI DE, DEXMETHYLPHENI DATE HYDROCHLORI DE
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
DI DANOSI NE, DI DANOSI NE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DOXEPI N HYDROCHLORI DE, DOXEPI N HYDROCHLORI DE
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
DOXYCYCLI NE, DOXYCYCLI NE
ENTACAPONE, ENTACAPONE
EPROSARTAN MESYLATE, EPROSARTAN MESYLATE
ESZOPI CLONE, ESZOPI CLONE
FENOFI BRATE ( MI CRONI ZED) , FENOFI BRATE
FENOFI BRATE, FENOFI BRATE
FENOFI BRI C ACI D, CHOLI NE FENOFI BRATE
FENOPROFEN CALCI UM, FENOPROFEN CALCI UM
FI NASTERI DE, FI NASTERI DE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
B - 93
* * M * *
*
*
MYLAN PHARMACEUTI CALS I NC
FLURAZEPAM HYDROCHLORI DE, FLURAZEPAM HYDROCHLORI DE
GABAPENTI N, GABAPENTI N
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I BANDRONATE SODI UM, I BANDRONATE SODI UM
I MI PRAMI NE PAMOATE, I MI PRAMI NE PAMOATE
I NDAPAMI DE, I NDAPAMI DE
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I RBESARTAN, I RBESARTAN
I TRACONAZOLE, I TRACONAZOLE
LANSOPRAZOLE, LANSOPRAZOLE
LEVETI RACETAM, LEVETI RACETAM
LI THI UM CARBONATE, LI THI UM CARBONATE
MALATHI ON, MALATHI ON
MAXZI DE, HYDROCHLOROTHI AZI DE
MAXZI DE- 25, HYDROCHLOROTHI AZI DE
MECLI ZI NE HYDROCHLORI DE, MECLI ZI NE HYDROCHLORI DE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
METHYCLOTHI AZI DE, METHYCLOTHI AZI DE
METOPROLOL SUCCI NATE, METOPROLOL SUCCI NATE
MI DODRI NE HYDROCHLORI DE, MI DODRI NE HYDROCHLORI DE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
MI RTAZAPI NE, MI RTAZAPI NE
MODAFI NI L, MODAFI NI L
MONTELUKAST SODI UM, MONTELUKAST SODI UM
MORPHI NE SULFATE, MORPHI NE SULFATE
MYCOPHENOLI C ACI D, MYCOPHENOLI C ACI D
NABUMETONE, NABUMETONE
NAPROXEN, NAPROXEN
NARATRI PTAN, NARATRI PTAN HYDROCHLORI DE
NEVI RAPI NE, NEVI RAPI NE
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
PAROXETI NE HYDROCHLORI DE, PAROXETI NE HYDROCHLORI DE
PHENYTOI N, PHENYTOI N
PI NDOLOL, PI NDOLOL
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM
PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
QUI NI NE SULFATE, QUI NI NE SULFATE
RABEPRAZOLE SODI UM, RABEPRAZOLE SODI UM
RAMI PRI L, RAMI PRI L
REPAGLI NI DE, REPAGLI NI DE
RI LUZOLE, RI LUZOLE
RI SPERI DONE, RI SPERI DONE
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SI LDENAFI L CI TRATE, SI LDENAFI L CI TRATE
SI MVASTATI N, SI MVASTATI N
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
TOLAZAMI DE, TOLAZAMI DE
TOLBUTAMI DE, TOLBUTAMI DE
TOLTERODI NE TARTRATE, TOLTERODI NE TARTRATE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
TRAZODONE HYDROCHLORI DE, TRAZODONE HYDROCHLORI DE
TRI AZOLAM, TRI AZOLAM
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
VALSARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
VORI CONAZOLE, VORI CONAZOLE
ZI DOVUDI NE, ZI DOVUDI NE
ZI PRASI DONE HYDROCHLORI DE, ZI PRASI DONE HYDROCHLORI DE
ZOLMI TRI PTAN, ZOLMI TRI PTAN
ZONI SAMI DE, ZONI SAMI DE
MYLAN PHARMACEUTI CALS I NC.
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 94
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * M * *
* MYLAN PHARMACEUTI CALS I NC.
FLUVASTATI N SODI UM, FLUVASTATI N SODI UM
NI ZATI DI NE, NI ZATI DI NE
OXYBUTYNI N CHLORI DE, OXYBUTYNI N CHLORI DE
MYLAN SPECLT
* MYLAN SPECI ALTY LP
ALBUTEROL SULFATE, ALBUTEROL SULFATE
EPI PEN J R. , EPI NEPHRI NE
EPI PEN, EPI NEPHRI NE
LEVALBUTEROL HYDROCHLORI DE, LEVALBUTEROL HYDROCHLORI DE
PERFOROMI ST, FORMOTEROL FUMARATE
MYLAN TECHNOLOGI ES
* MYLAN TECHNOLOGI ES I NC
CLONI DI NE, CLONI DI NE
ESTRADI OL, ESTRADI OL
FENTANYL- 100, FENTANYL
FENTANYL- 12, FENTANYL
FENTANYL- 25, FENTANYL
FENTANYL- 50, FENTANYL
FENTANYL- 75, FENTANYL
NI TROGLYCERI N, NI TROGLYCERI N
* * N * *
NATCO PHARMA
* NATCO PHARMA LTD
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
NATCO PHARMA LTD
* NATCO PHARMA LI MI TED
CHLOROQUI NE PHOSPHATE, CHLOROQUI NE PHOSPHATE
* NATCO PHARMA LTD
ANASTROZOLE, ANASTROZOLE
CHLOROQUI NE PHOSPHATE, CHLOROQUI NE PHOSPHATE
LANSOPRAZOLE, LANSOPRAZOLE
LETROZOLE, LETROZOLE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
TRI HEXYPHENI DYL HYDROCHLORI DE, TRI HEXYPHENI DYL HYDROCHLORI DE
NAUTI LUS NEUROSCI ENC
* NAUTI LUS NEUROSCI ENCES I NC
CAMBI A, DI CLOFENAC POTASSI UM
NAVI DEA BI OPHARMS
* NAVI DEA BI OPHARMACEUTI CALS I NC
LYMPHOSEEK KI T, TECHNETI UM TC- 99M TI LMANOCEPT
NAVI NTA LLC
* NAVI NTA LLC
BENZTROPI NE MESYLATE, BENZTROPI NE MESYLATE
FAMOTI DI NE, FAMOTI DI NE
FOMEPI ZOLE, FOMEPI ZOLE
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
NEPHRON
* NEPHRON CORP
ALBUTEROL SULFATE, ALBUTEROL SULFATE
I PRATROPI UM BROMI DE, I PRATROPI UM BROMI DE
* NEPHRON PHARMACEUTI CALS CORP
ALBUTEROL SULFATE AND I PRATROPI UM BROMI DE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
NESHER PHARMS
* NESHER PHARMACEUTI CALS USA LLC
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
I SOSORBI DE MONONI TRATE, I SOSORBI DE MONONI TRATE
MI CRO- K 10, POTASSI UM CHLORI DE
MI CRO- K, POTASSI UM CHLORI DE
MORPHI NE SULFATE, MORPHI NE SULFATE
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE












34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 95
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * N * *
NEW RI VER
* NEWRI VER PHARMACEUTI CALS I NC
PROFERDEX, I RON DEXTRAN
NEXGEN PHARMA
* NEXGEN PHARMA I NC
BUTALBI TAL AND ACETAMI NOPHEN, ACETAMI NOPHEN
BUTALBI TAL, ACETAMI NOPHEN AND CAFFEI NE, ACETAMI NOPHEN
CHENODI OL, CHENODI OL
GLYCOPYRROLATE, GLYCOPYRROLATE
MECAMYLAMI NE HYDROCHLORI DE, MECAMYLAMI NE HYDROCHLORI DE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 ( OTC)
NEXGEN PHARMA I NC
* NEXGEN PHARMA I NC
BUTALBI TAL, ACETAMI NOPHEN, CAFFEI NE AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
BUTALBI TAL, ASPI RI N, CAFFEI NE, AND CODEI NE PHOSPHATE, ASPI RI N
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
NEXTWAVE PHARMS
* NEXTWAVE PHARMACEUTI CALS I NC
QUI LLI VANT XR, METHYLPHENI DATE HYDROCHLORI DE
NEXUS PHARMS
* NEXUS PHARMACEUTI CALS I NC
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
LEVOFLOXACI N, LEVOFLOXACI N
NI AGARA PHARMS
* NI AGARA PHARMACEUTI CALS I NC
PUR- WASH, PURI FI ED WATER ( OTC)
NORTHSTAR HLTHCARE
* NORTHSTAR HEALTHCARE HOLDI NGS LTD
ALLOPURI NOL, ALLOPURI NOL
ATENOLOL, ATENOLOL
BACLOFEN, BACLOFEN
GEMFI BROZI L, GEMFI BROZI L
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
NOSTRUM
* NOSTRUM PHARMACEUTI CALS I NC
CARBAMAZEPI NE, CARBAMAZEPI NE
THEOPHYLLI NE, THEOPHYLLI NE
NOSTRUM LABS
* NOSTRUM LABORATORI ES I NC
PI ROXI CAM, PI ROXI CAM
SUCRALFATE, SUCRALFATE
NOSTRUM PHARMS LLC
* NOSTRUM PHARMACEUTI CALS LLC
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
NOVADEL
* NOVADEL PHARMA I NC
ZOLPI MI ST, ZOLPI DEM TARTRATE
NOVARTI S
* NOVARTI S CONSUMER HEALTH I NC
EXCEDRI N ( MI GRAI NE) , ACETAMI NOPHEN ( OTC)
HABI TROL, NI COTI NE ( OTC)
LAMI SI L AT, TERBI NAFI NE ( OTC)
LAMI SI L AT, TERBI NAFI NE HYDROCHLORI DE ( OTC)
LAMI SI L, TERBI NAFI NE HYDROCHLORI DE ( OTC)
NEXCEDE, KETOPROFEN ( OTC)
PREVACI D 24 HR, LANSOPRAZOLE ( OTC)
TAVI ST ALLERGY/ SI NUS/ HEADACHE, ACETAMI NOPHEN ( OTC)
THRI VE, NI COTI NE POLACRI LEX ( OTC)
TRANSDERM SCOP, SCOPOLAMI NE
VAGI STAT- 1, TI OCONAZOLE ( OTC)

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 96
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * N * *
* NOVARTI S CONSUMER HEALTH I NC
VOLTAREN, DI CLOFENAC SODI UM
* NOVARTI S PHARMACEUTI CALS CORP
AFI NI TOR, EVEROLI MUS
AMTURNI DE, ALI SKI REN HEMI FUMARATE
ARCAPTA NEOHALER, I NDACATEROL MALEATE
CATAFLAM, DI CLOFENAC POTASSI UM
CLOZARI L, CLOZAPI NE
COARTEM, ARTEMETHER
COMBI PATCH, ESTRADI OL
DESFERAL, DEFEROXAMI NE MESYLATE
DI OVAN HCT, HYDROCHLOROTHI AZI DE
DI OVAN, VALSARTAN
ESTRADERM, ESTRADI OL
EXELON, RI VASTI GMI NE
EXELON, RI VASTI GMI NE TARTRATE
EXFORGE HCT, AMLODI PI NE BESYLATE
EXFORGE, AMLODI PI NE BESYLATE
EXJ ADE, DEFERASI ROX
FAMVI R, FAMCI CLOVI R
FANAPT, I LOPERI DONE
FOCALI N XR, DEXMETHYLPHENI DATE HYDROCHLORI DE
FOCALI N, DEXMETHYLPHENI DATE HYDROCHLORI DE
FORADI L, FORMOTEROL FUMARATE
GI LENYA, FI NGOLI MOD
GLEEVEC, I MATI NI B MESYLATE
HYDERGI NE, ERGOLOI D MESYLATES
LAMI SI L, TERBI NAFI NE HYDROCHLORI DE
LAMPRENE, CLOFAZI MI NE
LESCOL XL, FLUVASTATI N SODI UM
LESCOL, FLUVASTATI N SODI UM
LOPRESSOR, METOPROLOL TARTRATE
LOTREL, AMLODI PI NE BESYLATE
MI ACALCI N, CALCI TONI N SALMON
MYFORTI C, MYCOPHENOLI C ACI D
NEORAL, CYCLOSPORI NE
OCUPRESS, CARTEOLOL HYDROCHLORI DE
RECLAST, ZOLEDRONI C ACI D
REGI TI NE, PHENTOLAMI NE MESYLATE
RI TALI N LA, METHYLPHENI DATE HYDROCHLORI DE
RI TALI N, METHYLPHENI DATE HYDROCHLORI DE
RI TALI N- SR, METHYLPHENI DATE HYDROCHLORI DE
SANDI MMUNE, CYCLOSPORI NE
SANDOSTATI N LAR, OCTREOTI DE ACETATE
SANDOSTATI N, OCTREOTI DE ACETATE
SI GNI FOR, PASI REOTI DE DI ASPARTATE
STARLI X, NATEGLI NI DE
TASI GNA, NI LOTI NI B HYDROCHLORI DE MONOHYDRATE
TAVI ST- 1, CLEMASTI NE FUMARATE ( OTC)
TEGRETOL, CARBAMAZEPI NE
TEGRETOL- XR, CARBAMAZEPI NE
TEKAMLO, ALI SKI REN HEMI FUMARATE
TEKTURNA HCT, ALI SKI REN HEMI FUMARATE
TEKTURNA, ALI SKI REN HEMI FUMARATE
TOBI PODHALER, TOBRAMYCI N
TRI LEPTAL, OXCARBAZEPI NE
TYZEKA, TELBI VUDI NE
VALTURNA, ALI SKI REN HEMI FUMARATE
VASOCI DI N, PREDNI SOLONE SODI UM PHOSPHATE
VI VELLE, ESTRADI OL
VI VELLE- DOT, ESTRADI OL
VOLTAREN, DI CLOFENAC SODI UM
VOLTAREN- XR, DI CLOFENAC SODI UM
ZOMETA, ZOLEDRONI C ACI D
ZORTRESS, EVEROLI MUS


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 97
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * N * *
NOVARTI S PHARM
* NOVARTI S PHARMACEUTI CAL CORP
AFI NI TOR DI SPERZ, EVEROLI MUS
NOVARTI S PHARMS
* NOVARTI S PHARMACEUTI CALS CORP
FEMARA, LETROZOLE
TOBI , TOBRAMYCI N
NOVAST LABS
* NOVAST LABORATORI ES CHI NA LTD
NORETHI NDRONE, NORETHI NDRONE
NOVAST LABS LTD
* NOVAST LABORATORI ES LTD
DASETTA 1/ 35, ETHI NYL ESTRADI OL
DASETTA 7/ 7/ 7, ETHI NYL ESTRADI OL
DESOGESTREL AND ETHI NYL ESTRADI OL, DESOGESTREL
ELI NEST, ETHI NYL ESTRADI OL
FALMI NA, ETHI NYL ESTRADI OL
LARI N 1/ 20, ETHI NYL ESTRADI OL
LARI N FE 1. 5/ 30, ETHI NYL ESTRADI OL
LARI N FE 1/ 20, ETHI NYL ESTRADI OL
LEVONEST, ETHI NYL ESTRADI OL
MONO- LI NYAH, ETHI NYL ESTRADI OL
NORETHI NDRONE, NORETHI NDRONE
PHI LI TH, ETHI NYL ESTRADI OL
PI MTREA, DESOGESTREL
TRI - LI NYAH, ETHI NYL ESTRADI OL
WERA, ETHI NYL ESTRADI OL
NOVEL LABS I NC
* NOVEL LABORATORI ES I NC
FAMOTI DI NE, FAMOTI DI NE
HOMATROPI NE METHYLBROMI DE AND HYDROCODONE BI TARTRATE, HOMATROPI NE METHYLBROMI DE
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL ( OTC)
METHYLERGONOVI NE MALEATE, METHYLERGONOVI NE MALEATE
MI SOPROSTOL, MI SOPROSTOL
PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
PEG- 3350; POTASSI UM CHLORI DE; SODI UM BI CARBONATE; SODI UM CHLORI DE, POLYETHYLENE GLYCOL
PHENELZI NE SULFATE, PHENELZI NE SULFATE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 ( OTC)
TEMAZEPAM, TEMAZEPAM
TI NI DAZOLE, TI NI DAZOLE
TRI METHOPRI M, TRI METHOPRI M
NOVEN
* NOVEN PHARMACEUTI CALS I NC
FENTANYL- 100, FENTANYL
FENTANYL- 25, FENTANYL
FENTANYL- 50, FENTANYL
FENTANYL- 75, FENTANYL
MI NI VELLE, ESTRADI OL
NOVEN PHARMS I NC
* NOVEN PHARMACEUTI CALS I NC
DAYTRANA, METHYLPHENI DATE
NOVEN THERAP
* NOVEN THERAPEUTI CS LLC
BRI SDELLE, PAROXETI NE MESYLATE
LI THOBI D, LI THI UM CARBONATE
PEXEVA, PAROXETI NE MESYLATE
NOVEX
* NOVEX PHARMA
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
NOVO NORDI SK
* NOVO NORDI SK PHARMACEUTI CALS I NC
GLUCAGEN, GLUCAGON HYDROCHLORI DE RECOMBI NANT
NOVO NORDI SK I NC





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 98
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * N * *
* NOVO NORDI SK I NC
ACTI VELLA, ESTRADI OL
LEVEMI R FLEXPEN, I NSULI N DETEMI R RECOMBI NANT
LEVEMI R, I NSULI N DETEMI R RECOMBI NANT
NORDI TROPI N FLEXPRO, SOMATROPI N RECOMBI NANT
NORDI TROPI N NORDI FLEX, SOMATROPI N RECOMBI NANT
NOVOLI N 70/ 30, I NSULI N RECOMBI NANT HUMAN ( OTC)
NOVOLI N N, I NSULI N SUSP I SOPHANE RECOMBI NANT HUMAN ( OTC)
NOVOLI N R, I NSULI N RECOMBI NANT HUMAN ( OTC)
NOVOLOG FLEXPEN, I NSULI N ASPART RECOMBI NANT
NOVOLOG MI X 70/ 30 FLEXPEN, I NSULI N ASPART PROTAMI NE RECOMBI NANT
NOVOLOG MI X 70/ 30, I NSULI N ASPART PROTAMI NE RECOMBI NANT
NOVOLOG PENFI LL, I NSULI N ASPART RECOMBI NANT
NOVOLOG, I NSULI N ASPART RECOMBI NANT
PRANDI MET, METFORMI N HYDROCHLORI DE
PRANDI N, REPAGLI NI DE
VAGI FEM, ESTRADI OL
VI CTOZA, LI RAGLUTI DE RECOMBI NANT
NOVOCOL
* NOVOCOL PHARMACEUTI CAL I NC
I SOCAI NE HYDROCHLORI DE, MEPI VACAI NE HYDROCHLORI DE
NOVOCOL I NC
* NOVOCOL I NC
LI DOCAI NE, LI DOCAI NE
NPS PHARMS I NC
* NPS PHARMACEUTI CALS I NC
GATTEX KI T, TEDUGLUTI DE RECOMBI NANT
NU PHARM
* NU PHARM I NC
DI VALPROEX SODI UM, DI VALPROEX SODI UM
NUPATHE
* NUPATHE I NC
ZECUI TY, SUMATRI PTAN SUCCI NATE
NYCOMED US
* NYCOMED US I NC
TERCONAZOLE, TERCONAZOLE
* * O * *
OAK PHARMS
* OAK PHARMACEUTI CALS I NC
EMLA, LI DOCAI NE
NEMBUTAL SODI UM, PENTOBARBI TAL SODI UM
XYLOCAI NE, LI DOCAI NE HYDROCHLORI DE
OAK PHARMS AKORN
* OAK PHARMACEUTI CALS I NC SUB AKORN I NC
COGENTI N, BENZTROPI NE MESYLATE
DI URI L, CHLOROTHI AZI DE SODI UM
* OAK PHARMACEUTI CALS I NC SUBSI DI ARY OF AKORN I NC
AZASI TE, AZI THROMYCI N
COSOPT PF, DORZOLAMI DE HYDROCHLORI DE
COSOPT, DORZOLAMI DE HYDROCHLORI DE
ODYSSEY PHARMS
* ODYSSEY PHARMACEUTI CALS I NC
ANTABUSE, DI SULFI RAM
NYSTATI N, NYSTATI N
SURMONTI L, TRI MI PRAMI NE MALEATE
URECHOLI NE, BETHANECHOL CHLORI DE
VI VACTI L, PROTRI PTYLI NE HYDROCHLORI DE
OHM
* OHM CORP
I BUPROFEN, I BUPROFEN ( OTC)
OHM LABS
* OHM LABORATORI ES I NC
ACETAMI NOPHEN, ACETAMI NOPHEN ( OTC)





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 99
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * O * *
* OHM LABORATORI ES I NC
I BUPROHM COLD AND SI NUS, I BUPROFEN ( OTC)
I BUPROHM, I BUPROFEN ( OTC)
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE ( OTC)
OLTA PHARMS
* OLTA PHARMACEUTI CALS CORP
LI NDANE, LI NDANE
OMAN PHARM PRODUCTS
* OMAN PHARMACEUTI CAL PRODUCTS CO LLC
NEOMYCI N SULFATE, NEOMYCI N SULFATE
ONCO THERAPI ES LTD
* ONCO THERAPI ES LTD
CARBOPLATI N, CARBOPLATI N
CI SPLATI N, CI SPLATI N
CLADRI BI NE, CLADRI BI NE
CYTARABI NE, CYTARABI NE
DOXORUBI CI N HYDROCHLORI DE, DOXORUBI CI N HYDROCHLORI DE
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
FLUDARABI NE PHOSPHATE, FLUDARABI NE PHOSPHATE
FLUOROURACI L, FLUOROURACI L
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
I DARUBI CI N HYDROCHLORI DE, I DARUBI CI N HYDROCHLORI DE
I FOSFAMI DE, I FOSFAMI DE
METHOTREXATE SODI UM PRESERVATI VE FREE, METHOTREXATE SODI UM
MI TOXANTRONE HYDROCHLORI DE, MI TOXANTRONE HYDROCHLORI DE
OXALI PLATI N, OXALI PLATI N
PACLI TAXEL, PACLI TAXEL
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
VI NORELBI NE, VI NORELBI NE
ONY
* ONY I NC
I NFASURF PRESERVATI VE FREE, CALFACTANT
ONYX PHARMS
* ONYX PHARMACEUTI CALS I NC
KYPROLI S, CARFI LZOMI B
OPTI MER PHARMS
* OPTI MER PHARMACEUTI CALS I NC
DI FI CI D, FI DAXOMI CI N
ORAPHARMA
* ORAPHARMA I NC
ARESTI N, MI NOCYCLI NE HYDROCHLORI DE
ORCHI D HLTHCARE
* ORCHI D HEALTHCARE
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
CEFADROXI L, CEFADROXI L/ CEFADROXI L HEMI HYDRATE
CEFDI NI R, CEFDI NI R
CEFPODOXI ME PROXETI L, CEFPODOXI ME PROXETI L
CEFPROZI L, CEFPROZI L
CEFUROXI ME AXETI L, CEFUROXI ME AXETI L
CEPHALEXI N, CEPHALEXI N
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES, CETI RI ZI NE HYDROCHLORI DE ( OTC)
DESLORATADI NE, DESLORATADI NE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
I BANDRONATE SODI UM, I BANDRONATE SODI UM
LEVETI RACETAM, LEVETI RACETAM
LEVOFLOXACI N, LEVOFLOXACI N
MODAFI NI L, MODAFI NI L
NARATRI PTAN, NARATRI PTAN HYDROCHLORI DE
OLANZAPI NE, OLANZAPI NE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 100
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * O * *
* ORCHI D HEALTHCARE
ZALEPLON, ZALEPLON
OREXO AB
* OREXO AB
ZUBSOLV, BUPRENORPHI NE HYDROCHLORI DE
ORGANON SUB MERCK
* ORGANON USA I NC SUB MERCK AND CO I NC
SAPHRI S, ASENAPI NE MALEATE
ORGANON USA I NC
* ORGANON USA I NC
CYCLESSA, DESOGESTREL
DESOGEN, DESOGESTREL
FOLLI STI M AQ, FOLLI TROPI N ALFA/ BETA
GANI RELI X ACETATE, GANI RELI X ACETATE
I MPLANON, ETONOGESTREL
NEXPLANON, ETONOGESTREL
NUVARI NG, ETHI NYL ESTRADI OL
PREGNYL, GONADOTROPI N, CHORI ONI C
REMERON SOLTAB, MI RTAZAPI NE
REMERON, MI RTAZAPI NE
ZEMURON, ROCURONI UM BROMI DE
ORI ON PHARMA
* ORI ON PHARMA
COMTAN, ENTACAPONE
STALEVO 100, CARBI DOPA
STALEVO 125, CARBI DOPA
STALEVO 150, CARBI DOPA
STALEVO 200, CARBI DOPA
STALEVO 50, CARBI DOPA
STALEVO 75, CARBI DOPA
ORI T LABS LLC
* ORI T LABORATORI ES LLC
BENZONATATE, BENZONATATE
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
ERGOCALCI FEROL, ERGOCALCI FEROL
LEVETI RACETAM, LEVETI RACETAM
ORPHAN EUROPE
* ORPHAN EUROPE
CARBAGLU, CARGLUMI C ACI D
ORTHO MCNEI L J ANSSEN
* ORTHO MCNEI L J ANSSEN PHARMACEUTI CALS I NC
NI ZORAL, KETOCONAZOLE
OSI PHARMS
* OSI PHARMACEUTI CALS I NC
TARCEVA, ERLOTI NI B HYDROCHLORI DE
OSMOTI CA PHARM
* OSMOTI CA PHARMACEUTI CAL CORP
NI FEDI PI NE, NI FEDI PI NE
OXYBUTYNI N CHLORI DE, OXYBUTYNI N CHLORI DE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
OSMOTI CA PHARM CORP
* OSMOTI CA PHARMACEUTI CAL CORP
KHEDEZLA, DESVENLAFAXI NE
OTSUKA
* OTSUKA PHARMACEUTI CAL CO LTD
ABI LI FY, ARI PI PRAZOLE
PLETAL, CI LOSTAZOL
* OTSUKA PHARMACEUTI CAL DEVELOPMENT AND COMMERCI ALI ZATI ON I NC
ABI LI FY, ARI PI PRAZOLE
OTSUKA AMERI CA
* OTSUKA AMERI CA PHARMACEUTI CALS I NC
BREATHTEK UBT FOR H- PYLORI , UREA C- 13
OTSUKA AMERI CA PHARM
* OTSUKA AMERI CA PHARMACEUTI CAL I NC
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 101
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * O * *
* OTSUKA AMERI CA PHARMACEUTI CAL I NC
SAMSCA, TOLVAPTAN
OTSUKA PHARM
* OTSUKA PHARMACEUTI CAL CO LTD
BUSULFEX, BUSULFAN
OTSUKA PHARM CO LTD
* OTSUKA PHARMACEUTI CAL CO LTD
ABI LI FY MAI NTENA KI T, ARI PI PRAZOLE
OUTLOOK PHARMS
* OUTLOOK PHARMACEUTI CALS I NC
DEXTROAMPHETAMI NE SULFATE, DEXTROAMPHETAMI NE SULFATE
* * P * *
PACI FI C PHARMA
* PACI FI C PHARMA
TI MOLOL MALEATE, TI MOLOL MALEATE
* PACI FI C PHARMA I NC
TI MOLOL MALEATE, TI MOLOL MALEATE
PACI RA PHARMS I NC
* PACI RA PHARMACEUTI CALS I NC
DEPOCYT, CYTARABI NE
EXPAREL, BUPI VACAI NE
PACK PHARMS LLC
* PACK PHARMACEUTI CALS LLC
CROMOLYN SODI UM, CROMOLYN SODI UM
PADDOCK
* PADDOCK LABORATORI ES I NC
BENZPHETAMI NE HYDROCHLORI DE, BENZPHETAMI NE HYDROCHLORI DE
PADDOCK LABS
* PADDOCK LABORATORI ES I NC
CLI NDAMYCI N PALMI TATE HYDROCHLORI DE, CLI NDAMYCI N PALMI TATE HYDROCHLORI DE
PADDOCK LLC
* PADDOCK LABORATORI ES LLC
BROMOCRI PTI NE MESYLATE, BROMOCRI PTI NE MESYLATE
CAFFEI NE CI TRATE, CAFFEI NE CI TRATE
CALCI UM ACETATE, CALCI UM ACETATE
CI CLOPI ROX, CI CLOPI ROX
CLI NDA- DERM, CLI NDAMYCI N PHOSPHATE
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
CLOTRI MAZOLE, CLOTRI MAZOLE
COLI STI METHATE SODI UM, COLI STI METHATE SODI UM
COLOCORT, HYDROCORTI SONE
COMPRO, PROCHLORPERAZI NE
DI HYDROERGOTAMI NE MESYLATE, DI HYDROERGOTAMI NE MESYLATE
ERYTHRA- DERM, ERYTHROMYCI N
FLAVOXATE HYDROCHLORI DE, FLAVOXATE HYDROCHLORI DE
I NDOMETHACI N, I NDOMETHACI N
KI ONEX, SODI UM POLYSTYRENE SULFONATE
LAX- LYTE WI TH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
LORAZEPAM, LORAZEPAM
MI DAMOR, AMI LORI DE HYDROCHLORI DE
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
MOEXI PRI L HYDROCHLORI DE, MOEXI PRI L HYDROCHLORI DE
MORPHI NE SULFATE, MORPHI NE SULFATE
NARATRI PTAN, NARATRI PTAN HYDROCHLORI DE
NYSTOP, NYSTATI N
PODOFI LOX, PODOFI LOX
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
POTASSI UM CHLORI DE, POTASSI UM CHLORI DE
PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
REPAGLI NI DE, REPAGLI NI DE
SODI UM POLYSTYRENE SULFONATE, SODI UM POLYSTYRENE SULFONATE
TESTOSTERONE CYPI ONATE, TESTOSTERONE CYPI ONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
TROSPI UM CHLORI DE, TROSPI UM CHLORI DE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 102
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * P * *
PAI
* PHARMACEUTI CAL ASSOCI ATES I NC
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
PALADI N LABS
* PALADI N LABS USA I NC
ANTI ZOL, FOMEPI ZOLE
PANACEA BI OTEC LTD
* PANACEA BI OTEC LTD
TACROLI MUS, TACROLI MUS
PAR FORM
* PAR FORMULATI ONS PRI VATE LTD
LABETALOL HYDROCHLORI DE, LABETALOL HYDROCHLORI DE
MAFENI DE ACETATE, MAFENI DE ACETATE
PAR PHARM
* PAR PHARMACEUTI CAL
NABUMETONE, NABUMETONE
OMEPRAZOLE AND SODI UM BI CARBONATE, OMEPRAZOLE
PROPAFENONE HYDROCHLORI DE, PROPAFENONE HYDROCHLORI DE
* PAR PHARMACEUTI CAL I NC
ALPRAZOLAM, ALPRAZOLAM
AMI LORI DE HYDROCHLORI DE, AMI LORI DE HYDROCHLORI DE
AMLODI PI NE BESYLATE AND BENAZEPRI L HYDROCHLORI DE, AMLODI PI NE BESYLATE
CABERGOLI NE, CABERGOLI NE
CALCI TONI N- SALMON, CALCI TONI N SALMON
CAPOTEN, CAPTOPRI L
CHOLESTYRAMI NE LI GHT, CHOLESTYRAMI NE
CHOLESTYRAMI NE, CHOLESTYRAMI NE
CLOMI PHENE CI TRATE, CLOMI PHENE CI TRATE
CLONAZEPAM, CLONAZEPAM
CYPROHEPTADI NE HYDROCHLORI DE, CYPROHEPTADI NE HYDROCHLORI DE
DEXAMETHASONE, DEXAMETHASONE
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
DI PHENOXYLATE HYDROCHLORI DE AND ATROPI NE SULFATE, ATROPI NE SULFATE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DOXEPI N HYDROCHLORI DE, DOXEPI N HYDROCHLORI DE
DOXYCYCLI NE, DOXYCYCLI NE
ESTAZOLAM, ESTAZOLAM
FENTANYL CI TRATE, FENTANYL CI TRATE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FLUTAMI DE, FLUTAMI DE
GLI PI ZI DE, GLI PI ZI DE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDRA- ZI DE, HYDRALAZI NE HYDROCHLORI DE
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
HYDROXYUREA, HYDROXYUREA
I BUPROFEN, I BUPROFEN ( OTC)
I MI PRAMI NE HYDROCHLORI DE, I MI PRAMI NE HYDROCHLORI DE
I SOSORBI DE DI NI TRATE, I SOSORBI DE DI NI TRATE
LAMOTRI GI NE, LAMOTRI GI NE
LEVETI RACETAM, LEVETI RACETAM
MECLI ZI NE HYDROCHLORI DE, MECLI ZI NE HYDROCHLORI DE
MEGACE ES, MEGESTROL ACETATE
MEGESTROL ACETATE, MEGESTROL ACETATE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METRONI DAZOLE, METRONI DAZOLE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
MI NOXI DI L, MI NOXI DI L
NASCOBAL, CYANOCOBALAMI N
NATEGLI NI DE, NATEGLI NI DE
NI FEDI PI NE, NI FEDI PI NE
OLANZAPI NE AND FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
OLANZAPI NE, OLANZAPI NE
OMEPRAZOLE AND SODI UM BI CARBONATE, OMEPRAZOLE
OXANDROLONE, OXANDROLONE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 ( OTC)








34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 103
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * P * *
* PAR PHARMACEUTI CAL I NC
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RI SPERI DONE, RI SPERI DONE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TORSEMI DE, TORSEMI DE
TRAMADOL HYDROCHLORI DE AND ACETAMI NOPHEN, ACETAMI NOPHEN
TRANYLCYPROMI NE SULFATE, TRANYLCYPROMI NE SULFATE
TRAVOPROST, TRAVOPROST
URSODI OL, URSODI OL
VERAPAMI L HYDROCHLORI DE, VERAPAMI L HYDROCHLORI DE
PAR PHARM I NC
* PAR PHARMACEUTI CAL I NC
AMLODI PI NE BESYLATE AND VALSARTAN, AMLODI PI NE BESYLATE
FENTANYL- 100, FENTANYL
FENTANYL- 25, FENTANYL
FENTANYL- 50, FENTANYL
FENTANYL- 75, FENTANYL
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
MORPHI NE SULFATE, MORPHI NE SULFATE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
PARAGON BI OTECK
* PARAGON BI OTECK I NC
PHENYLEPHRI NE HYDROCHLORI DE, PHENYLEPHRI NE HYDROCHLORI DE
PARAPRO LLC
* PARAPRO LLC
NATROBA, SPI NOSAD
PARKE DAVI S
* PARKE DAVI S DI V WARNER LAMBERT CO
CELONTI N, METHSUXI MI DE
DI LANTI N, PHENYTOI N SODI UM
DI LANTI N- 125, PHENYTOI N
NARDI L, PHENELZI NE SULFATE
NEURONTI N, GABAPENTI N
ZARONTI N, ETHOSUXI MI DE
* PARKE DAVI S PHARMACEUTI CAL RESEARCH DI V WARNER LAMBERT CO
ZARONTI N, ETHOSUXI MI DE
PEDI ATRX
* PEDI ATRX I NC
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
PEDI NOL
* PEDI NOL PHARMACAL I NC
GRI S- PEG, GRI SEOFULVI N, ULTRAMI CROSI ZE
PERNI X THERAP
* PERNI X THERAPEUTI CS LLC
CEDAX, CEFTI BUTEN DI HYDRATE
PERNI X THERAPS LLC
* PERNI X THERAPEUTI CS LLC
SI LENOR, DOXEPI N HYDROCHLORI DE
PERRI GO
* PERRI GO CO
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CI CLOPI ROX, CI CLOPI ROX
CI METI DI NE, CI METI DI NE ( OTC)
CLEMASTI NE FUMARATE, CLEMASTI NE FUMARATE ( OTC)
CLI NDETS, CLI NDAMYCI N PHOSPHATE
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
ERYTHROMYCI N, ERYTHROMYCI N
FAMOTI DI NE, FAMOTI DI NE
FAMOTI DI NE, FAMOTI DI NE ( OTC)
HALOBETASOL PROPI ONATE, HALOBETASOL PROPI ONATE
I BUPROFEN, I BUPROFEN ( OTC)
J UNI OR STRENGTH I BUPROFEN, I BUPROFEN ( OTC)
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE ( OTC)
MI CONAZOLE NI TRATE COMBI NATI ON PACK, MI CONAZOLE NI TRATE ( OTC)
MI NOXI DI L ( FOR MEN) , MI NOXI DI L ( OTC)










34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 104
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * P * *
* PERRI GO CO
MI NOXI DI L ( FOR WOMEN) , MI NOXI DI L ( OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
NI COTI NE POLACRI LEX, NI COTI NE POLACRI LEX ( OTC)
PSEUDOEPHEDRI NE HYDROCHLORI DE, PSEUDOEPHEDRI NE HYDROCHLORI DE ( OTC)
STI E- CORT, HYDROCORTI SONE
PERRI GO CO TENNESSEE
* PERRI GO CO TENNESSEE I NC
BACI TRACI N ZI NC AND POLYMYXI N B SULFATE, BACI TRACI N ZI NC
BACI TRACI N, BACI TRACI N
BACI TRACI N- NEOMYCI N- POLYMYXI N W/ HYDROCORTI SONE ACETATE, BACI TRACI N
ERYTHROMYCI N, ERYTHROMYCI N
GENTAMI CI N SULFATE, GENTAMI CI N SULFATE
GRI SEOFULVI N, GRI SEOFULVI N, MI CROSI ZE
NEOMYCI N AND POLYMYXI N B SULFATES AND BACI TRACI N ZI NC, BACI TRACI N ZI NC
NEOMYCI N AND POLYMYXI N B SULFATES AND DEXAMETHASONE, DEXAMETHASONE
SULFACETAMI DE SODI UM, SULFACETAMI DE SODI UM
PERRI GO I SRAEL
* PERRI GO I SRAEL PHARMACEUTI CALS
FLUOCI NONI DE, FLUOCI NONI DE
* PERRI GO I SRAEL PHARMACEUTI CALS LTD
BUTOCONAZOLE NI TRATE, BUTOCONAZOLE NI TRATE
CLI NDAMYCI N PHOSPHATE AND BENZOYL PEROXI DE, BENZOYL PEROXI DE
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
FLUOCI NOLONE ACETONI DE, FLUOCI NOLONE ACETONI DE
FLUTI CASONE PROPI ONATE, FLUTI CASONE PROPI ONATE
HALOBETASOL PROPI ONATE, HALOBETASOL PROPI ONATE
I MI QUI MOD, I MI QUI MOD
KETOCONAZOLE, KETOCONAZOLE
MESALAMI NE, MESALAMI NE
MI NOXI DI L, MI NOXI DI L ( OTC)
NI TROGLYCERI N, NI TROGLYCERI N
TESTOSTERONE, TESTOSTERONE
PERRI GO NEW YORK
* PERRI GO NEWYORK I NC
ACETAMI NOPHEN, ACETAMI NOPHEN ( OTC)
AMMONI UM LACTATE, AMMONI UM LACTATE
BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
CENTANY, MUPI ROCI N
CI CLOPI ROX, CI CLOPI ROX
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
DESONI DE, DESONI DE
DESOXI METASONE, DESOXI METASONE
ECONAZOLE NI TRATE, ECONAZOLE NI TRATE
ERYTHROMYCI N, ERYTHROMYCI N
FLUTI CASONE PROPI ONATE, FLUTI CASONE PROPI ONATE
GENTAMI CI N SULFATE, GENTAMI CI N SULFATE
HYDROCORTI SONE VALERATE, HYDROCORTI SONE VALERATE
HYDROCORTI SONE, HYDROCORTI SONE
KETOCONAZOLE, KETOCONAZOLE
MI NOXI DI L EXTRA STRENGTH ( FOR MEN) , MI NOXI DI L ( OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPI ROCI N, MUPI ROCI N
NYSTATI N, NYSTATI N
PERMETHRI N, PERMETHRI N
PERMETHRI N, PERMETHRI N ( OTC)
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
SELENI UM SULFI DE, SELENI UM SULFI DE
TERCONAZOLE, TERCONAZOLE
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
PERRI GO R AND D
* PERRI GO R AND D CO
CALCI UM CARBONATE, FAMOTI DI NE AND MAGNESI UM HYDROXI DE, CALCI UM CARBONATE ( OTC)
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES, CETI RI ZI NE HYDROCHLORI DE ( OTC)



























34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 105
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * P * *
* PERRI GO R AND D CO
CETI RI ZI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
DESLORATADI NE, DESLORATADI NE
GUAI FENESI N, GUAI FENESI N ( OTC)
I BUPROFEN AND DI PHENHYDRAMI NE CI TRATE, DI PHENHYDRAMI NE CI TRATE ( OTC)
I BUPROFEN, I BUPROFEN
I BUPROFEN, I BUPROFEN ( OTC)
LANSOPRAZOLE, LANSOPRAZOLE ( OTC)
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL ( OTC)
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE ( OTC)
MI CONAZOLE NI TRATE, MI CONAZOLE NI TRATE ( OTC)
NAPROXEN, NAPROXEN
NI COTI NE POLACRI LEX, NI COTI NE POLACRI LEX ( OTC)
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 ( OTC)
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
PERRI GO UK FI NCO
* PERRI GO UK FI NCO LTD PARTNERSHI P
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
PETNET
* PETNET SOLUTI ONS I NC
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F- 18
PF PRI SM
* PF PRI SM CV
LYRI CA, PREGABALI N
PF PRI SM CV
* PF PRI SM CV
RAPAMUNE, SI ROLI MUS
TORI SEL, TEMSI ROLI MUS
TYGACI L, TI GECYCLI NE
XALKORI , CRI ZOTI NI B
XELJ ANZ, TOFACI TI NI B CI TRATE
ZMAX, AZI THROMYCI N
PFI ZER
* PFI ZER CENTRAL RESEARCH
DI FLUCAN, FLUCONAZOLE
ZI THROMAX, AZI THROMYCI N
* PFI ZER CHEMI CALS DI V PFI ZER I NC
DI FLUCAN, FLUCONAZOLE
ZI THROMAX, AZI THROMYCI N
* PFI ZER I NC
ACOVA, ARGATROBAN
ADVI L ALLERGY AND CONGESTI ON RELI EF, CHLORPHENI RAMI NE MALEATE ( OTC)
ADVI L ALLERGY SI NUS, CHLORPHENI RAMI NE MALEATE ( OTC)
ADVI L COLD AND SI NUS, I BUPROFEN ( OTC)
ADVI L CONGESTI ON RELI EF, I BUPROFEN ( OTC)
ADVI L LI QUI - GELS, I BUPROFEN ( OTC)
ADVI L MI GRAI NE LI QUI - GELS, I BUPROFEN ( OTC)
ADVI L PM, DI PHENHYDRAMI NE CI TRATE ( OTC)
ADVI L PM, DI PHENHYDRAMI NE HYDROCHLORI DE ( OTC)
ADVI L, I BUPROFEN ( OTC)
ALAVERT, LORATADI NE ( OTC)
AXI D AR, NI ZATI DI NE ( OTC)
CADUET, AMLODI PI NE BESYLATE
CALAN SR, VERAPAMI L HYDROCHLORI DE
CARDURA XL, DOXAZOSI N MESYLATE
CHI LDREN' S ADVI L ALLERGY SI NUS, CHLORPHENI RAMI NE MALEATE ( OTC)
CHI LDREN' S ADVI L COLD, I BUPROFEN ( OTC)
CHI LDREN' S ADVI L, I BUPROFEN ( OTC)
CHI LDREN' S ADVI L- FLAVORED, I BUPROFEN ( OTC)
DI FLUCAN I N DEXTROSE 5%I N PLASTI C CONTAI NER, FLUCONAZOLE
DI FLUCAN I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, FLUCONAZOLE
DI FLUCAN I N SODI UM CHLORI DE 0. 9%, FLUCONAZOLE




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 106
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * P * *
* PFI ZER I NC
ELELYSO, TALI GLUCERASE ALFA
FLAGYL I . V. RTU I N PLASTI C CONTAI NER, METRONI DAZOLE
GEODON, ZI PRASI DONE HYDROCHLORI DE
GEODON, ZI PRASI DONE MESYLATE
GLUCOTROL XL, GLI PI ZI DE
GLUCOTROL, GLI PI ZI DE
HEPARI N SODI UM PRESERVATI VE FREE, HEPARI N SODI UM
HEPARI N SODI UM, HEPARI N SODI UM
I NLYTA, AXI TI NI B
J UNI OR STRENGTH ADVI L, I BUPROFEN ( OTC)
LI PI TOR, ATORVASTATI N CALCI UM
LORATADI NE, LORATADI NE ( OTC)
NAVANE, THI OTHI XENE
NORVASC, AMLODI PI NE BESYLATE
PEDI ATRI C ADVI L, I BUPROFEN ( OTC)
PROCARDI A, NI FEDI PI NE
REVATI O, SI LDENAFI L CI TRATE
SONATA, ZALEPLON
TESSALON, BENZONATATE
TOVI AZ, FESOTERODI NE FUMARATE
UNASYN, AMPI CI LLI N SODI UM
VFEND, VORI CONAZOLE
ZI THROMAX, AZI THROMYCI N
* PFI ZER LABORATORI ES DI V PFI ZER I NC
CARDURA, DOXAZOSI N MESYLATE
DI ABI NESE, CHLORPROPAMI DE
FELDENE, PI ROXI CAM
MI NI PRESS, PRAZOSI N HYDROCHLORI DE
PERMAPEN, PENI CI LLI N G BENZATHI NE
PFI ZERPEN, PENI CI LLI N G POTASSI UM
PROCARDI A XL, NI FEDI PI NE
TERRAMYCI N W/ POLYMYXI N B SULFATE, OXYTETRACYCLI NE HYDROCHLORI DE
UNASYN, AMPI CI LLI N SODI UM
VI BRAMYCI N, DOXYCYCLI NE
VI BRAMYCI N, DOXYCYCLI NE CALCI UM
VI BRAMYCI N, DOXYCYCLI NE HYCLATE
VI STARI L, HYDROXYZI NE PAMOATE
* PFI ZER PHARMACEUTI CALS I NC
ZOLOFT, SERTRALI NE HYDROCHLORI DE
* PFI ZER PHARMACEUTI CALS PRODUCTI ON CORP LTD
TI KOSYN, DOFETI LI DE
PFI ZER CONS HLTHCARE
* PFI ZER CONSUMER HEALTHCARE
ADVI L, I BUPROFEN SODI UM ( OTC)
PFI ZER I NC
* PFI ZER I NC
CAMPTOSAR, I RI NOTECAN HYDROCHLORI DE
CHANTI X, VARENI CLI NE TARTRATE
ELLENCE, EPI RUBI CI N HYDROCHLORI DE
GEODON, ZI PRASI DONE HYDROCHLORI DE
NI COTROL, NI COTI NE
PFI ZER I RELAND
* PFI ZER I RELAND PHARMACEUTI CALS
RELPAX, ELETRI PTAN HYDROBROMI DE
VI AGRA, SI LDENAFI L CI TRATE
PFI ZER PHARMS
* PFI ZER PHARMACEUTI CALS LTD
ACCUPRI L, QUI NAPRI L HYDROCHLORI DE
ACCURETI C, HYDROCHLOROTHI AZI DE
DI LANTI N, PHENYTOI N
LOPI D, GEMFI BROZI L
NEURONTI N, GABAPENTI N
NI TROSTAT, NI TROGLYCERI N
PHARM ASSOC
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 107
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * P * *
* PHARMACEUTI CAL ASSOC I NC
CYPROHEPTADI NE HYDROCHLORI DE, CYPROHEPTADI NE HYDROCHLORI DE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
LORAZEPAM, LORAZEPAM
NORTRI PTYLI NE HYDROCHLORI DE, NORTRI PTYLI NE HYDROCHLORI DE
PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
* PHARMACEUTI CAL ASSOC I NC DI V BEACH PRODUCTS
AMANTADI NE HYDROCHLORI DE, AMANTADI NE HYDROCHLORI DE
CI METI DI NE HYDROCHLORI DE, CI METI DI NE HYDROCHLORI DE
DI PHENHYDRAMI NE HYDROCHLORI DE, DI PHENHYDRAMI NE HYDROCHLORI DE
ETHOSUXI MI DE, ETHOSUXI MI DE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FLUPHENAZI NE HYDROCHLORI DE, FLUPHENAZI NE HYDROCHLORI DE
HALOPERI DOL, HALOPERI DOL LACTATE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
LACTULOSE, LACTULOSE
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
OXYBUTYNI N CHLORI DE, OXYBUTYNI N CHLORI DE
PREDNI SOLONE, PREDNI SOLONE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
TRI HEXYPHENI DYL HYDROCHLORI DE, TRI HEXYPHENI DYL HYDROCHLORI DE
VALPROI C ACI D, VALPROI C ACI D
* PHARMACEUTI CAL ASSOCI ATES I NC
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
PHARMACEUTI CS
* PHARMACEUTI CS I NTERNATI ONAL I NC
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
PHARMACHEMI E
* PHARMACHEMI E BV
CARBOPLATI N, CARBOPLATI N
CI SPLATI N, CI SPLATI N
DOXORUBI CI N HYDROCHLORI DE, DOXORUBI CI N HYDROCHLORI DE
PHARMACHEMI E BV
* PHARMACHEMI E BV
METHOTREXATE PRESERVATI VE FREE, METHOTREXATE SODI UM
METHOTREXATE SODI UM PRESERVATI VE FREE, METHOTREXATE SODI UM
PHARMACI A AND UPJ OHN
* PHARMACI A AND UPJ OHN
XANAX XR, ALPRAZOLAM
* PHARMACI A AND UPJ OHN CO
ANSAI D, FLURBI PROFEN
AROMASI N, EXEMESTANE
AZULFI DI NE EN- TABS, SULFASALAZI NE
AZULFI DI NE, SULFASALAZI NE
BACI TRACI N, BACI TRACI N
CAVERJ ECT I MPULSE, ALPROSTADI L
CAVERJ ECT, ALPROSTADI L
CLEOCI N HYDROCHLORI DE, CLI NDAMYCI N HYDROCHLORI DE
CLEOCI N PHOSPHATE I N DEXTROSE 5%I N PLASTI C CONTAI NER, CLI NDAMYCI N PHOSPHATE
CLEOCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
CLEOCI N T, CLI NDAMYCI N PHOSPHATE
CLEOCI N, CLI NDAMYCI N PALMI TATE HYDROCHLORI DE
CLEOCI N, CLI NDAMYCI N PHOSPHATE
COLESTI D, COLESTI POL HYDROCHLORI DE
CORTEF, HYDROCORTI SONE
CORVERT, I BUTI LI DE FUMARATE
CYKLOKAPRON, TRANEXAMI C ACI D
DEPO- ESTRADI OL, ESTRADI OL CYPI ONATE
DEPO- MEDROL, METHYLPREDNI SOLONE ACETATE
DEPO- PROVERA, MEDROXYPROGESTERONE ACETATE
DEPO- TESTOSTERONE, TESTOSTERONE CYPI ONATE
DETROL LA, TOLTERODI NE TARTRATE
DETROL, TOLTERODI NE TARTRATE
DI DREX, BENZPHETAMI NE HYDROCHLORI DE
EMCYT, ESTRAMUSTI NE PHOSPHATE SODI UM
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 108
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * P * *
* PHARMACI A AND UPJ OHN CO
ESTRI NG, ESTRADI OL
FLAVORED COLESTI D, COLESTI POL HYDROCHLORI DE
GENOTROPI N PRESERVATI VE FREE, SOMATROPI N RECOMBI NANT
GENOTROPI N, SOMATROPI N RECOMBI NANT
GLYNASE, GLYBURI DE
GLYSET, MI GLI TOL
HALCI ON, TRI AZOLAM
HEMABATE, CARBOPROST TROMETHAMI NE
I DAMYCI N PFS, I DARUBI CI N HYDROCHLORI DE
LI NCOCI N, LI NCOMYCI N HYDROCHLORI DE
MEDROL, METHYLPREDNI SOLONE
MYCOBUTI N, RI FABUTI N
NI COTROL, NI COTI NE
OGEN . 625, ESTROPI PATE
OGEN 1. 25, ESTROPI PATE
OGEN 2. 5, ESTROPI PATE
OGEN 5, ESTROPI PATE
PREPI DI L, DI NOPROSTONE
PROSTI N E2, DI NOPROSTONE
PROSTI N VR PEDI ATRI C, ALPROSTADI L
PROVERA, MEDROXYPROGESTERONE ACETATE
R- GENE 10, ARGI NI NE HYDROCHLORI DE
SOLU- CORTEF, HYDROCORTI SONE SODI UM SUCCI NATE
SOLU- MEDROL, METHYLPREDNI SOLONE SODI UM SUCCI NATE
SOMAVERT, PEGVI SOMANT
XALATAN, LATANOPROST
XANAX, ALPRAZOLAM
ZI NECARD, DEXRAZOXANE HYDROCHLORI DE
ZYVOX, LI NEZOLI D
* PHARMACI A AND UPJ OHN SUB PFI ZER I NC
DEPO- SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE
PHARMACYCLI CS I NC
* PHARMACYCLI CS I NC
I MBRUVI CA, I BRUTI NI B
PHARMAFORCE
* PHARMAFORCE I NC
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
NANDROLONE DECANOATE, NANDROLONE DECANOATE
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
PHARMALUCENCE
* PHARMALUCENCE I NC
AN- SULFUR COLLOI D, TECHNETI UM TC- 99M SULFUR COLLOI D KI T
CI S- MDP, TECHNETI UM TC- 99M MEDRONATE KI T
CI S- PYRO, TECHNETI UM TC- 99M PYROPHOSPHATE KI T
HEPATOLI TE, TECHNETI UM TC- 99M DI SOFENI N KI T
TECHNETI UM TC 99M SESTAMI BI , TECHNETI UM TC- 99M SESTAMI BI KI T
TECHNETI UM TC- 99M MEBROFENI N, TECHNETI UM TC- 99M MEBROFENI N KI T
PHARMAX
* PHARMAX GROUP I NC
BETHANECHOL CHLORI DE, BETHANECHOL CHLORI DE
PHARMAXI S LTD
* PHARMAXI S LTD
ARI DOL KI T, MANNI TOL
PHARMS
* PHARMACEUTI CALS I NTERNATI ONAL
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
PHOTOCURE ASA
* PHOTOCURE ASA
CYSVI EWKI T, HEXAMI NOLEVULI NATE HYDROCHLORI DE
PI ERRE FABRE
* PI ERRE FABRE MEDI CAMENT
NAVELBI NE, VI NORELBI NE TARTRATE
PI ERREL
* PI ERREL S. P. A.



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 109
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * P * *
* PI ERREL S. P. A.
ORABLOC, ARTI CAI NE HYDROCHLORI DE
PI NNACLE BI OLGS
* PI NNACLE BI OLOGI CS I NC
PHOTOFRI N, PORFI MER SODI UM
PI RAMAL CRI TI CAL
* PI RAMAL CRI TI CAL CARE I NC
ENFLURANE, ENFLURANE
I SOFLURANE, I SOFLURANE
SOJ OURN, SEVOFLURANE
PLD ACQUI SI TI ONS
* PLD ACQUI SI TI ONS LLC
I BUPROFEN, I BUPROFEN ( OTC)
PLI VA
* PLI VA I NC
AZI THROMYCI N, AZI THROMYCI N
BENZTROPI NE MESYLATE, BENZTROPI NE MESYLATE
CHLORPROPAMI DE, CHLORPROPAMI DE
CI METI DI NE, CI METI DI NE
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
DOXAZOSI N MESYLATE, DOXAZOSI N MESYLATE
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
KETOCONAZOLE, KETOCONAZOLE
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
METRONI DAZOLE, METRONI DAZOLE
NAPROXEN, NAPROXEN
PENTOXI FYLLI NE, PENTOXI FYLLI NE
PROPAFENONE HYDROCHLORI DE, PROPAFENONE HYDROCHLORI DE
PROPRANOLOL HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
THEOPHYLLI NE, THEOPHYLLI NE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
TRAZODONE HYDROCHLORI DE, TRAZODONE HYDROCHLORI DE
TRI AMTERENE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
WARFARI N SODI UM, WARFARI N SODI UM
PLI VA HRVATSKA DOO
* PLI VA HRVATSKA DOO
ADAPALENE, ADAPALENE
CARVEDI LOL, CARVEDI LOL
CI LOSTAZOL, CI LOSTAZOL
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
RI SPERI DONE, RI SPERI DONE
PLI VA LACHEMA
* PLI VA LACHEMA AS
CARBOPLATI N, CARBOPLATI N
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
PLI VA PHARM I ND
* PLI VA PHARMACEUTI CAL I NDUSTRY I NC
TORSEMI DE, TORSEMI DE
PLX PHARMA
* PLX PHARMA I NC
ASPI RI N, ASPI RI N ( OTC)
POHL BOSKAMP
* POHL BOSKAMP
NI TROLI NGUAL PUMPSPRAY, NI TROGLYCERI N
POLYMEDI CA
* POLYMEDI CA I NDUSTRI ES I NC
NEOPAP, ACETAMI NOPHEN ( OTC)
PRECI SI ON DERMAT
* PRECI SI ON DERMATOLOGY I NC



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 110
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * P * *
* PRECI SI ON DERMATOLOGY I NC
CLI NDAGEL, CLI NDAMYCI N PHOSPHATE
LOCOI D LI POCREAM, HYDROCORTI SONE BUTYRATE
LOCOI D, HYDROCORTI SONE BUTYRATE
MI NOCI N, MI NOCYCLI NE HYDROCHLORI DE
PODOFI LOX, PODOFI LOX
TRETI NOI N, TRETI NOI N
PRECI SI ON DOSE
* PRECI SI ON DOSE I NC
RI SPERI DONE, RI SPERI DONE
PRI NSTON I NC
* PRI NSTON PHARMACEUTI CAL I NC
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
I RBESARTAN, I RBESARTAN
LEVETI RACETAM, LEVETI RACETAM
LI SI NOPRI L AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LI SI NOPRI L, LI SI NOPRI L
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
METHOCARBAMOL, METHOCARBAMOL
NEVI RAPI NE, NEVI RAPI NE
RI SPERI DONE, RI SPERI DONE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
PROCTER AND GAMBLE
* PROCTER AND GAMBLE PHARMACEUTI CALS I NC SUB PROCTER AND GAMBLE CO
DI DRONEL, ETI DRONATE DI SODI UM
PROF DSPLS
* PROFESSI ONAL DI SPOSABLES I NC
PREVANTI CS MAXI SWABSTI CK, CHLORHEXI DI NE GLUCONATE ( OTC)
PREVANTI CS SWAB, CHLORHEXI DI NE GLUCONATE ( OTC)
PREVANTI CS SWABSTI CK, CHLORHEXI DI NE GLUCONATE ( OTC)
PROMETHEUS LABS
* PROMETHEUS LABORATORI ES I NC
HELI DAC, BI SMUTH SUBSALI CYLATE
I MURAN, AZATHI OPRI NE
LOTRONEX, ALOSETRON HYDROCHLORI DE
MERCAPTOPURI NE, MERCAPTOPURI NE
RI DAURA, AURANOFI N
ZYLOPRI M, ALLOPURI NOL
PROMI US PHARMA
* PROMI US PHARMA LLC
SECTRAL, ACEBUTOLOL HYDROCHLORI DE
TENEX, GUANFACI NE HYDROCHLORI DE
PROMI US PHARMA LLC
* PROMI US PHARMA LLC
CLODERM, CLOCORTOLONE PI VALATE
PROSAM LABS
* PROSAM LABS LLC
BACLOFEN, BACLOFEN
BUSPI RONE HYDROCHLORI DE, BUSPI RONE HYDROCHLORI DE
CARI SOPRODOL AND ASPI RI N, ASPI RI N
CARI SOPRODOL, ASPI RI N AND CODEI NE PHOSPHATE, ASPI RI N
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
PAROXETI NE HYDROCHLORI DE, PAROXETI NE HYDROCHLORI DE
RI MACTANE, RI FAMPI N
RI SPERI DONE, RI SPERI DONE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SI MVASTATI N, SI MVASTATI N
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
PROSTRAKAN I NC
* PROSTRAKAN I NC
FARESTON, TOREMI FENE CI TRATE
SANCUSO, GRANI SETRON
PROVENSI S

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 111
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * P * *
* PROVENSI S LTD
VARI THENA, POLI DOCANOL
PROVI DENT PHARM
* PROVI DENT PHARMACEUTI CAL I NC
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
PULSI ON MEDCL
* PULSI ON MEDI CAL SYSTEMS AG
I NDOCYANI NE GREEN, I NDOCYANI NE GREEN
PURACAP PHARM
* PURACAP PHARMACEUTI CAL LLC
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
MELOXI CAM, MELOXI CAM
PURDUE GMP
* PURDUE GMP CENTER LLC DBA THE CHAO CENTER I NDUSTRI AL PHARMACY
SEROMYCI N, CYCLOSERI NE
PURDUE PHARM PRODS
* PURDUE PHARMACEUTI CAL PRODUCTS LP
DI LAUDI D, HYDROMORPHONE HYDROCHLORI DE
DI LAUDI D- HP, HYDROMORPHONE HYDROCHLORI DE
PURDUE PHARMA
* PURDUE PHARMA PRODUCTS LP
I NTERMEZZO, ZOLPI DEM TARTRATE
PURDUE PHARMA LP
* PURDUE PHARMA LP
BUTRANS, BUPRENORPHI NE
MS CONTI N, MORPHI NE SULFATE
OXYCONTI N, OXYCODONE HYDROCHLORI DE
PUREPAC PHARM
* PUREPAC PHARMACEUTI CAL CO
DI PYRI DAMOLE, DI PYRI DAMOLE
* * Q * *
QOL MEDCL
* QOL MEDI CAL LLC
ETHAMOLI N, ETHANOLAMI NE OLEATE
SUCRAI D, SACROSI DASE
QUESTCOR PHARMS
* QUESTCOR PHARMACEUTI CALS I NC
H. P. ACTHAR GEL, CORTI COTROPI N
* * R * *
RANBAXY
* RANBAXY I NC
ABSORI CA, I SOTRETI NOI N
GLYCOPYRROLATE, GLYCOPYRROLATE
* RANBAXY LABORATORI ES I NC
EURAX, CROTAMI TON
EXELDERM, SULCONAZOLE NI TRATE
FAMOTI DI NE, FAMOTI DI NE ( OTC)
HALOG, HALCI NONI DE
KENALOG, TRI AMCI NOLONE ACETONI DE
LAC- HYDRI N, AMMONI UM LACTATE
RI SPERI DONE, RI SPERI DONE
ULTRAVATE, HALOBETASOL PROPI ONATE
* RANBAXY LABORATORI ES LTD
ACYCLOVI R, ACYCLOVI R
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
AMOXI CI LLI N AND CLAVULANATE POTASSI UM, AMOXI CI LLI N
AMOXI CI LLI N, AMOXI CI LLI N
BENAZEPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, BENAZEPRI L HYDROCHLORI DE
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
CARVEDI LOL, CARVEDI LOL
CEFADROXI L, CEFADROXI L/ CEFADROXI L HEMI HYDRATE
CEFPODOXI ME PROXETI L, CEFPODOXI ME PROXETI L









34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 112
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * R * *
* RANBAXY LABORATORI ES LTD
CEFUROXI ME AXETI L, CEFUROXI ME AXETI L
CEPHALEXI N, CEPHALEXI N
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CLARI THROMYCI N, CLARI THROMYCI N
CLI NDAMYCI N HYDROCHLORI DE, CLI NDAMYCI N HYDROCHLORI DE
CLORAZEPATE DI POTASSI UM, CLORAZEPATE DI POTASSI UM
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DOXYCYCLI NE, DOXYCYCLI NE
FENOFI BRATE, FENOFI BRATE
FLECAI NI DE ACETATE, FLECAI NI DE ACETATE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FOSI NOPRI L SODI UM AND HYDROCHLOROTHI AZI DE, FOSI NOPRI L SODI UM
GABAPENTI N, GABAPENTI N
LORATADI NE AND PSEUDOEPHEDRI NE SULFATE, LORATADI NE ( OTC)
LORATADI NE REDI DOSE, LORATADI NE ( OTC)
LORATADI NE, LORATADI NE ( OTC)
LORAZEPAM, LORAZEPAM
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
NEFAZODONE HYDROCHLORI DE, NEFAZODONE HYDROCHLORI DE
ONDANSETRON, ONDANSETRON
OXCARBAZEPI NE, OXCARBAZEPI NE
PSEUDOEPHEDRI NE HYDROCHLORI DE, PSEUDOEPHEDRI NE HYDROCHLORI DE ( OTC)
QUI NAPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
QUI NAPRI L HYDROCHLORI DE, QUI NAPRI L HYDROCHLORI DE
RI SPERI DONE, RI SPERI DONE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SI MVASTATI N, SI MVASTATI N
SOTRET, I SOTRETI NOI N
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TOPI RAMATE, TOPI RAMATE
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
* RANBAXY PHARMACEUTI CALS I NC
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
AMOXI CI LLI N AND CLAVULANATE POTASSI UM, AMOXI CI LLI N
AMOXI CI LLI N, AMOXI CI LLI N
AVENTYL HYDROCHLORI DE, NORTRI PTYLI NE HYDROCHLORI DE
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
LI SI NOPRI L AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LI SI NOPRI L, LI SI NOPRI L
LOPERAMI DE HYDROCHLORI DE AND SI METHI CONE, LOPERAMI DE HYDROCHLORI DE ( OTC)
NALOXONE HYDROCHLORI DE AND PENTAZOCI NE HYDROCHLORI DE, NALOXONE HYDROCHLORI DE
RI OMET, METFORMI N HYDROCHLORI DE
SOTRET, I SOTRETI NOI N
RANBAXY LABS LTD
* RANBAXY LABORATORI ES LI MI TED
NAPROXEN SODI UM, NAPROXEN SODI UM ( OTC)
* RANBAXY LABORATORI ES LTD
ACETAMI NOPHEN, ACETAMI NOPHEN ( OTC)
ATORVASTATI N CALCI UM, ATORVASTATI N CALCI UM
FELODI PI NE, FELODI PI NE
MORPHI NE SULFATE, MORPHI NE SULFATE
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
RAPTOR PHARMS
* RAPTOR PHARMACEUTI CALS CORP
PROCYSBI , CYSTEAMI NE BI TARTRATE
RARE DI S THERAP
* RARE DI SEASE THERAPEUTI CS I NC
CYSTADANE, BETAI NE HYDROCHLORI DE
RECI P





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 113
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * R * *
* RECI P AB
THYROSAFE, POTASSI UM I ODI DE ( OTC)
RECKI TT BENCKI SER
* RECKI TT BENCKI SER LLC
DELSYM, DEXTROMETHORPHAN POLI STI REX ( OTC)
MUCI NEX D, GUAI FENESI N ( OTC)
MUCI NEX DM, DEXTROMETHORPHAN HYDROBROMI DE ( OTC)
MUCI NEX, GUAI FENESI N ( OTC)
* RECKI TT BENCKI SER PHARMACEUTI CALS I NC
BUPRENEX, BUPRENORPHI NE HYDROCHLORI DE
SUBOXONE, BUPRENORPHI NE HYDROCHLORI DE
RECORDATI RARE
* RECORDATI RARE DI SEASES I NC
CHEMET, SUCCI MER
COSMEGEN, DACTI NOMYCI N
DESOXYN, METHAMPHETAMI NE HYDROCHLORI DE
I NDOCI N, I NDOMETHACI N SODI UM
MUSTARGEN, MECHLORETHAMI NE HYDROCHLORI DE
NEOPROFEN, I BUPROFEN LYSI NE
PEGANONE, ETHOTOI N
TRANXENE, CLORAZEPATE DI POTASSI UM
REMPEX PHARMS I NC
* REMPEX PHARMACEUTI CALS I NC
MI NOCI N, MI NOCYCLI NE HYDROCHLORI DE
RENAI SSANCE PHARMA
* RENAI SSANCE PHARMA US HOLDI NGS I NC
ELI MI TE, PERMETHRI N
RHODES PHARMS
* RHODES PHARMACEUTI CALS LP
MORPHI NE SULFATE, MORPHI NE SULFATE
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
THEOPHYLLI NE, THEOPHYLLI NE
UNI PHYL, THEOPHYLLI NE
RHODI A
* RHODI A LTD
I SOFLURANE, I SOFLURANE
RI CONPHARMA LLC
* RI CONPHARMA LLC
GRI SEOFULVI N, ULTRAMI CROSI ZE, GRI SEOFULVI N, ULTRAMI CROSI ZE
ROCHE PALO
* ROCHE PALO ALTO LLC
CELLCEPT, MYCOPHENOLATE MOFETI L
CELLCEPT, MYCOPHENOLATE MOFETI L HYDROCHLORI DE
CYTOVENE, GANCI CLOVI R SODI UM
EC- NAPROSYN, NAPROXEN
NAPROSYN, NAPROXEN
ROCKWELL MEDCL
* ROCKWELL MEDI CAL TECHNOLOGI ES I NC
CALCI TRI OL, CALCI TRI OL
ROMARK
* ROMARK LABORATORI ES
ALI NI A, NI TAZOXANI DE
ROSEDALE THERAPEUTI C
* ROSEDALE THERAPEUTI CS
ERGOMAR, ERGOTAMI NE TARTRATE
ROUSES POI NT PHARMS
* ROUSES POI NT PHARMACEUTI CALS LLC
LEVETI RACETAM, LEVETI RACETAM
ROXANE
* ROXANE LABORATORI ES I NC
ACARBOSE, ACARBOSE
ALENDRONATE SODI UM, ALENDRONATE SODI UM
ALPRAZOLAM, ALPRAZOLAM
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 114
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * R * *
* ROXANE LABORATORI ES I NC
ANASTROZOLE, ANASTROZOLE
AZATHI OPRI NE, AZATHI OPRI NE
BALSALAZI DE DI SODI UM, BALSALAZI DE DI SODI UM
BI CALUTAMI DE, BI CALUTAMI DE
BUPRENORPHI NE HYDROCHLORI DE, BUPRENORPHI NE HYDROCHLORI DE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CALCI TRI OL, CALCI TRI OL
CALCI UM ACETATE, CALCI UM ACETATE
CEVI MELI NE HYDROCHLORI DE, CEVI MELI NE HYDROCHLORI DE
CI LOSTAZOL, CI LOSTAZOL
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
CLARI THROMYCI N, CLARI THROMYCI N
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
CLOTRI MAZOLE, CLOTRI MAZOLE
CODEI NE SULFATE, CODEI NE SULFATE
CYCLOPHOSPHAMI DE, CYCLOPHOSPHAMI DE
DEXAMETHASONE I NTENSOL, DEXAMETHASONE
DEXAMETHASONE, DEXAMETHASONE
DI AZEPAM I NTENSOL, DI AZEPAM
DI AZEPAM, DI AZEPAM
DI GOXI N, DI GOXI N
DI PHENOXYLATE HYDROCHLORI DE AND ATROPI NE SULFATE,
DOLOPHI NE HYDROCHLORI DE, METHADONE HYDROCHLORI DE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DOXERCALCI FEROL, DOXERCALCI FEROL
EXEMESTANE, EXEMESTANE
FAMCI CLOVI R, FAMCI CLOVI R
FLECAI NI DE ACETATE, FLECAI NI DE ACETATE
FLUCONAZOLE, FLUCONAZOLE
FLUTI CASONE PROPI ONATE, FLUTI CASONE PROPI ONATE
FUROSEMI DE, FUROSEMI DE
ATROPI NE SULFATE
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
HYDROMORPHONE HYDROCHLORI DE, HYDROMORPHONE HYDROCHLORI DE
I MI PRAMI NE PAMOATE, I MI PRAMI NE PAMOATE
I PRATROPI UM BROMI DE, I PRATROPI UM BROMI DE
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I RBESARTAN, I RBESARTAN
LACTULOSE, LACTULOSE
LETROZOLE, LETROZOLE
LEUCOVORI N CALCI UM, LEUCOVORI N CALCI UM
LEVETI RACETAM, LEVETI RACETAM
LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE
LI DOCAI NE HYDROCHLORI DE, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE VI SCOUS, LI DOCAI NE HYDROCHLORI DE
LI THI UM CARBONATE, LI THI UM CARBONATE
LI THI UM CI TRATE, LI THI UM CI TRATE
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE ( OTC)
LORAZEPAM I NTENSOL, LORAZEPAM
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
MEFLOQUI NE HYDROCHLORI DE, MEFLOQUI NE HYDROCHLORI DE
MEGESTROL ACETATE, MEGESTROL ACETATE
MEPERI DI NE HYDROCHLORI DE, MEPERI DI NE HYDROCHLORI DE
MERCAPTOPURI NE, MERCAPTOPURI NE
METHADONE HYDROCHLORI DE I NTENSOL, METHADONE HYDROCHLORI DE
METHADONE HYDROCHLORI DE, METHADONE HYDROCHLORI DE
METHOTREXATE SODI UM, METHOTREXATE SODI UM
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
MONTELUKAST SODI UM, MONTELUKAST SODI UM
MORPHI NE SULFATE, MORPHI NE SULFATE
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
NAPROXEN, NAPROXEN
NARATRI PTAN, NARATRI PTAN HYDROCHLORI DE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 115
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * R * *
* ROXANE LABORATORI ES I NC
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
OXCARBAZEPI NE, OXCARBAZEPI NE
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
OXYMORPHONE HYDROCHLORI DE, OXYMORPHONE HYDROCHLORI DE
PERI NDOPRI L ERBUMI NE, PERI NDOPRI L ERBUMI NE
PHENOXYBENZAMI NE HYDROCHLORI DE, PHENOXYBENZAMI NE HYDROCHLORI DE
PI LOCARPI NE HYDROCHLORI DE, PI LOCARPI NE HYDROCHLORI DE
PREDNI SONE I NTENSOL, PREDNI SONE
PREDNI SONE, PREDNI SONE
PROPANTHELI NE BROMI DE, PROPANTHELI NE BROMI DE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
PROTRI PTYLI NE HYDROCHLORI DE, PROTRI PTYLI NE HYDROCHLORI DE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
RAMI PRI L, RAMI PRI L
RI SPERI DONE, RI SPERI DONE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
ROXI CET, ACETAMI NOPHEN
ROXI LOX, ACETAMI NOPHEN
SODI UM POLYSTYRENE SULFONATE, SODI UM POLYSTYRENE SULFONATE
TI NI DAZOLE, TI NI DAZOLE
TORSEMI DE, TORSEMI DE
TRI AZOLAM, TRI AZOLAM
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
ZALEPLON, ZALEPLON
ZI DOVUDI NE, ZI DOVUDI NE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
* * S * *
SAGE PRODS
* SAGE PRODUCTS I NC
CHLORHEXI DI NE GLUCONATE, CHLORHEXI DI NE GLUCONATE ( OTC)
SAGENT AGI LA
* SAGENT AGI LA LLC
ACETAZOLAMI DE SODI UM, ACETAZOLAMI DE SODI UM
BUPI VACAI NE HYDROCHLORI DE PRESERVATI VE FREE, BUPI VACAI NE HYDROCHLORI DE
BUPI VACAI NE HYDROCHLORI DE, BUPI VACAI NE HYDROCHLORI DE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
SAGENT PHARMS
* SAGENT PHARMACEUTI CALS I NC
ATRACURI UM BESYLATE PRESERVATI VE FREE, ATRACURI UM BESYLATE
ATRACURI UM BESYLATE, ATRACURI UM BESYLATE
CAFFEI NE CI TRATE, CAFFEI NE CI TRATE
CALCI TRI OL, CALCI TRI OL
CARBOPLATI N, CARBOPLATI N
DOXORUBI CI N HYDROCHLORI DE, DOXORUBI CI N HYDROCHLORI DE
FLUMAZENI L, FLUMAZENI L
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
HALOPERI DOL, HALOPERI DOL LACTATE
HEPARI N SODI UM PRESERVATI VE FREE, HEPARI N SODI UM
HEPARI N SODI UM, HEPARI N SODI UM
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
LEUCOVORI N CALCI UM PRESERVATI VE FREE, LEUCOVORI N CALCI UM
LEVETI RACETAM, LEVETI RACETAM
LEVOFLOXACI N, LEVOFLOXACI N
MESNA, MESNA
NAFCI LLI N SODI UM, NAFCI LLI N SODI UM
OCTREOTI DE ACETATE ( PRESERVATI VE FREE) , OCTREOTI DE ACETATE
OCTREOTI DE ACETATE, OCTREOTI DE ACETATE
ORPHENADRI NE CI TRATE, ORPHENADRI NE CI TRATE
OXACI LLI N SODI UM, OXACI LLI N SODI UM
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
SAGENT STRI DES
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 116
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* SAGENT STRI DES LLC
AZI THROMYCI N, AZI THROMYCI N
BACI TRACI N, BACI TRACI N
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
LABETALOL HYDROCLORI DE, LABETALOL HYDROCHLORI DE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MI DAZOLAM HYDROCHLORI DE PRESERVATI VE FREE, MI DAZOLAM HYDROCHLORI DE
MI DOZALAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
POLYMYCI N B SULFATE, POLYMYXI N B SULFATE
ROCURONI UM BROMI DE, ROCURONI UM BROMI DE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
SALI X PHARMS
* SALI X PHARMACEUTI CALS I NC
ANUSOL HC, HYDROCORTI SONE
APRI SO, MESALAMI NE
COLAZAL, BALSALAZI DE DI SODI UM
DI URI L, CHLOROTHI AZI DE
FULYZAQ, CROFELEMER
GI AZO, BALSALAZI DE DI SODI UM
METOZOLV ODT, METOCLOPRAMI DE HYDROCHLORI DE
MOVI PREP, ASCORBI C ACI D
OSMOPREP, SODI UM PHOSPHATE, DI BASI C, ANHYDROUS
PEPCI D, FAMOTI DI NE
RELI STOR, METHYLNALTREXONE BROMI DE
XI FAXAN, RI FAXI MI N
SALI X PHARMS I NC
* SALI X PHARMACEUTI CALS I NC
FENOGLI DE, FENOFI BRATE
GLUMETZA, METFORMI N HYDROCHLORI DE
ZEGERI D, OMEPRAZOLE
SAMSON MEDCL
* SAMSON MEDI CAL TECHNOLOGI ES LLC
CEFAZOLI N SODI UM, CEFAZOLI N SODI UM
SANDOZ
* SANDOZ
DOCETAXEL, DOCETAXEL
* SANDOZ CANADA I NC
ANECTI NE, SUCCI NYLCHOLI NE CHLORI DE
ARI STOSPAN, TRI AMCI NOLONE HEXACETONI DE
BRI MONI DI NE TARTRATE, BRI MONI DI NE TARTRATE
COSYNTROPI N, COSYNTROPI N
DI GOXI N, DI GOXI N
DORZOLAMI DE HYDROCHLORI DE, DORZOLAMI DE HYDROCHLORI DE
ESTRADI OL VALERATE, ESTRADI OL VALERATE
FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE
FLUMAZENI L, FLUMAZENI L
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
I NFUVI TE ADULT, ALPHA- TOCOPHEROL ACETATE
I NFUVI TE PEDI ATRI C ( PHARMACY BULK PACKAGE) , ASCORBI C ACI D
I NFUVI TE PEDI ATRI C, ASCORBI C ACI D
I SONI AZI D, I SONI AZI D
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
METHYLPREDNI SOLONE ACETATE, METHYLPREDNI SOLONE ACETATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
REGONOL, PYRI DOSTI GMI NE BROMI DE
ROCURONI UM BROMI DE, ROCURONI UM BROMI DE
TESTOSTERONE CYPI ONATE, TESTOSTERONE CYPI ONATE
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
* SANDOZ I NC
ALPRAZOLAM, ALPRAZOLAM


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 117
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* SANDOZ I NC
ALTAVERA, ETHI NYL ESTRADI OL
AMANTADI NE HYDROCHLORI DE, AMANTADI NE HYDROCHLORI DE
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
AMI TRI PTYLI NE HYDROCHLORI DE, AMI TRI PTYLI NE HYDROCHLORI DE
AMOXI CI LLI N AND CLAVULANATE POTASSI UM, AMOXI CI LLI N
AMOXI CI LLI N, AMOXI CI LLI N
AMPI CI LLI N AND SULBACTAM, AMPI CI LLI N SODI UM
AMPI CI LLI N SODI UM, AMPI CI LLI N SODI UM
AMPI CI LLI N TRI HYDRATE, AMPI CI LLI N/ AMPI CI LLI N TRI HYDRATE
ANASTROZOLE, ANASTROZOLE
APREPI TANT, APREPI TANT
ARGATROBAN I N SODI UM CHLORI DE, ARGATROBAN
ATENOLOL, ATENOLOL
AZI THROMYCI N, AZI THROMYCI N
BENAZEPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, BENAZEPRI L HYDROCHLORI DE
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
BI CALUTAMI DE, BI CALUTAMI DE
BI SOPROLOL FUMARATE AND HYDROCHLOROTHI AZI DE, BI SOPROLOL FUMARATE
BI SOPROLOL FUMARATE, BI SOPROLOL FUMARATE
BUDESONI DE, BUDESONI DE
BUMETANI DE, BUMETANI DE
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
CAFERGOT, CAFFEI NE
CANDESARTAN CI LEXETI L, CANDESARTAN CI LEXETI L
CAPTOPRI L, CAPTOPRI L
CARBOPLATI N, CARBOPLATI N
CARI SOPRODOL AND ASPI RI N, ASPI RI N
CARI SOPRODOL, ASPI RI N AND CODEI NE PHOSPHATE, ASPI RI N
CARVEDI LOL, CARVEDI LOL
CEFADROXI L, CEFADROXI L/ CEFADROXI L HEMI HYDRATE
CEFAZOLI N SODI UM, CEFAZOLI N SODI UM
CEFDI NI R, CEFDI NI R
CEFPODOXI ME PROXETI L, CEFPODOXI ME PROXETI L
CEFPROZI L, CEFPROZI L
CEFTRI AXONE, CEFTRI AXONE SODI UM
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE AND PSEUDOEPHEDRI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CHLORPROMAZI NE HYDROCHLORI DE, CHLORPROMAZI NE HYDROCHLORI DE
CHOLESTYRAMI NE LI GHT, CHOLESTYRAMI NE
CHOLESTYRAMI NE, CHOLESTYRAMI NE
CI LOSTAZOL, CI LOSTAZOL
CLARI THROMYCI N, CLARI THROMYCI N
CLEMASTI NE FUMARATE, CLEMASTI NE FUMARATE
CLEMASTI NE FUMARATE, CLEMASTI NE FUMARATE ( OTC)
CLOMI PRAMI NE HYDROCHLORI DE, CLOMI PRAMI NE HYDROCHLORI DE
CLONAZEPAM, CLONAZEPAM
COSYNTROPI N, COSYNTROPI N
CYCLOSPORI NE, CYCLOSPORI NE
DESI PRAMI NE HYDROCHLORI DE, DESI PRAMI NE HYDROCHLORI DE
DESLORATADI NE, DESLORATADI NE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMI NE
DI CLOFENAC POTASSI UM, DI CLOFENAC POTASSI UM
DI CLOFENAC SODI UM AND MI SOPROSTOL, DI CLOFENAC SODI UM
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
DI CLOXACI LLI N SODI UM, DI CLOXACI LLI N SODI UM
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DORZOLAMI DE HYDROCHLORI DE AND TI MOLOL MALEATE, DORZOLAMI DE HYDROCHLORI DE
ENOXAPARI N SODI UM ( PRESERVATI VE FREE) , ENOXAPARI N SODI UM
EPLERENONE, EPLERENONE
ESTARYLLA, ETHI NYL ESTRADI OL
ETODOLAC, ETODOLAC
FLUDARABI NE PHOSPHATE, FLUDARABI NE PHOSPHATE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 118
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* SANDOZ I NC
FLUOROURACI L, FLUOROURACI L
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FLUPHENAZI NE HYDROCHLORI DE, FLUPHENAZI NE HYDROCHLORI DE
FLUVOXAMI NE MALEATE, FLUVOXAMI NE MALEATE
FOSI NOPRI L SODI UM AND HYDROCHLOROTHI AZI DE, FOSI NOPRI L SODI UM
FOSI NOPRI L SODI UM, FOSI NOPRI L SODI UM
FUROSEMI DE, FUROSEMI DE
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
GLI PI ZI DE, GLI PI ZI DE
GRI SEOFULVI N, GRI SEOFULVI N, MI CROSI ZE
HALOPERI DOL, HALOPERI DOL
HEPARI N SODI UM, HEPARI N SODI UM
HYDROXYCHLOROQUI NE SULFATE, HYDROXYCHLOROQUI NE SULFATE
HYDROXYZI NE PAMOATE, HYDROXYZI NE PAMOATE
I DARUBI CI N HYDROCHLORI DE, I DARUBI CI N HYDROCHLORI DE
I MI PRAMI NE HYDROCHLORI DE, I MI PRAMI NE HYDROCHLORI DE
I NDOMETHACI N, I NDOMETHACI N
I NTROVALE, ETHI NYL ESTRADI OL
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I RBESARTAN, I RBESARTAN
I SONI AZI D, I SONI AZI D
I SOSORBI DE DI NI TRATE, I SOSORBI DE DI NI TRATE
I TRACONAZOLE, I TRACONAZOLE
LABETALOL HYDROCHLORI DE, LABETALOL HYDROCHLORI DE
LANSOPRAZOLE, LANSOPRAZOLE
LEFLUNOMI DE, LEFLUNOMI DE
LEUPROLI DE ACETATE, LEUPROLI DE ACETATE
LEVETI RACETAM, LEVETI RACETAM
LEVOCETI RI ZI NE DI HYDROCHLORI DE, LEVOCETI RI ZI NE DI HYDROCHLORI DE
LEVOFLOXACI N, LEVOFLOXACI N
LI SI NOPRI L AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LI SI NOPRI L, LI SI NOPRI L
LONOX, ATROPI NE SULFATE
LORATADI NE, LORATADI NE ( OTC)
LORAZEPAM, LORAZEPAM
LORYNA, DROSPI RENONE
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
LOVASTATI N, LOVASTATI N
MECLI ZI NE HYDROCHLORI DE, MECLI ZI NE HYDROCHLORI DE
MEFLOQUI NE HYDROCHLORI DE, MEFLOQUI NE HYDROCHLORI DE
MEROPENEM, MEROPENEM
METAXALONE, METAXALONE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
METHADONE HYDROCHLORI DE, METHADONE HYDROCHLORI DE
METHAZOLAMI DE, METHAZOLAMI DE
METHI MAZOLE, METHI MAZOLE
METHOCARBAMOL, METHOCARBAMOL
METHYLPREDNI SOLONE, METHYLPREDNI SOLONE
METOLAZONE, METOLAZONE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MI DODRI NE HYDROCHLORI DE, MI DODRI NE HYDROCHLORI DE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
MI RTAZAPI NE, MI RTAZAPI NE
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
NABUMETONE, NABUMETONE
NADOLOL, NADOLOL
NAFCI LLI N SODI UM, NAFCI LLI N SODI UM
NAPROXEN, NAPROXEN
NARATRI PTAN, NARATRI PTAN HYDROCHLORI DE
NI TROFURANTOI N ( MONOHYDRATE/ MACROCRYSTALS) , NI TROFURANTOI N
NI ZATI DI NE, NI ZATI DI NE
OLANZAPI NE AND FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
OMEPRAZOLE, OMEPRAZOLE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 119
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* SANDOZ I NC
OMNI TROPE, SOMATROPI N RECOMBI NANT
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON, ONDANSETRON
ORPHENADRI NE CI TRATE, ASPI RI N, AND CAFFEI NE, ASPI RI N
ORPHENADRI NE CI TRATE, ORPHENADRI NE CI TRATE
OXACI LLI N SODI UM, OXACI LLI N SODI UM
OXALI PLATI N, OXALI PLATI N
OXAPROZI N, OXAPROZI N
OXAZEPAM, OXAZEPAM
PENI CI LLI N G POTASSI UM, PENI CI LLI N G POTASSI UM
PENI CI LLI N G SODI UM, PENI CI LLI N G SODI UM
PENI CI LLI N V POTASSI UM, PENI CI LLI N V POTASSI UM
PERPHENAZI NE, PERPHENAZI NE
PHENDI METRAZI NE TARTRATE, PHENDI METRAZI NE TARTRATE
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
PI OGLI TAZONE HYDROCHLORI DE AND GLI MEPI RI DE, GLI MEPI RI DE
PI OGLI TAZONE HYDROCHLORI DE AND METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
PI PERACI LLI N AND TAZOBACTAM, PI PERACI LLI N SODI UM
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
PROCHLORPERAZI NE MALEATE, PROCHLORPERAZI NE MALEATE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
QUI NI DI NE SULFATE, QUI NI DI NE SULFATE
RAMI PRI L, RAMI PRI L
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
REPAGLI NI DE, REPAGLI NI DE
RESERPI NE, RESERPI NE
RI BAVI RI N, RI BAVI RI N
RI FAMPI N, RI FAMPI N
RI SPERI DONE, RI SPERI DONE
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
SOTALOL HYDROCHLORI DE, SOTALOL HYDROCHLORI DE
SPI RONOLACTONE, SPI RONOLACTONE
SULFADI AZI NE, SULFADI AZI NE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
SYEDA, DROSPI RENONE
TACROLI MUS, TACROLI MUS
TAMSULOSI N HYDROCHLORI DE, TAMSULOSI N HYDROCHLORI DE
TEMAZEPAM, TEMAZEPAM
TERAZOSI N HYDROCHLORI DE, TERAZOSI N HYDROCHLORI DE
THI OTHI XENE, THI OTHI XENE
TRI - ESTARYLLA, ETHI NYL ESTRADI OL
TRI AMTERENE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
TRI FLUOPERAZI NE HYDROCHLORI DE, TRI FLUOPERAZI NE HYDROCHLORI DE
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
ZONI SAMI DE, ZONI SAMI DE
SANDOZ CANADA I NC
* SANDOZ CANADA I NC
PARI CALCI TOL, PARI CALCI TOL
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
SANDOZ I NC
* SANDOZ I NC
AMOXI CI LLI N AND CLAVULANATE POTASSI UM, AMOXI CI LLI N
ATORVASTATI N CALCI UM, ATORVASTATI N CALCI UM
CEFTRI AXONE, CEFTRI AXONE SODI UM
CI SATRACURI UM BESYLATE PRESERVATI VE FREE, CI SATRACURI UM BESYLATE
CI SATRACURI UM BESYLATE, CI SATRACURI UM BESYLATE
CLI NDAMYCI N PHOSPHATE I N 5%DEXTROSE I N PLASTI C CONTAI NER, CLI NDAMYCI N PHOSPHATE
DOXORUBI CI N HYDROCHLORI DE, DOXORUBI CI N HYDROCHLORI DE
ENOXAPARI N SODI UM, ENOXAPARI N SODI UM
MONTELUKAST SODI UM, MONTELUKAST SODI UM









34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 120
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* SANDOZ I NC
OLANZAPI NE, OLANZAPI NE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
VORI CONAZOLE, VORI CONAZOLE
ZI PRASI DONE HYDROCHLORI DE, ZI PRASI DONE HYDROCHLORI DE
SANOCHEMI A CORP USA
* SANOCHEMI A CORP USA
SCANLUX- 300, I OPAMI DOL
SCANLUX- 370, I OPAMI DOL
SANOFI AVENTI S US
* SANOFI AVENTI S US I NC
J EVTANA KI T, CABAZI TAXEL
* SANOFI AVENTI S US LLC
ALLEGRA ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
ALLEGRA HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
ALLEGRA, FEXOFENADI NE HYDROCHLORI DE
ALLEGRA- D 12 HOUR ALLERGY AND CONGESTI ON, FEXOFENADI NE HYDROCHLORI DE ( OTC)
ALLEGRA- D 24 HOUR ALLERGY AND CONGESTI ON, FEXOFENADI NE HYDROCHLORI DE ( OTC)
AMARYL, GLI MEPI RI DE
AMBI EN CR, ZOLPI DEM TARTRATE
AMBI EN, ZOLPI DEM TARTRATE
ANZEMET, DOLASETRON MESYLATE
API DRA SOLOSTAR, I NSULI N GLULI SI NE RECOMBI NANT
API DRA, I NSULI N GLULI SI NE RECOMBI NANT
ARALEN, CHLOROQUI NE PHOSPHATE
ARAVA, LEFLUNOMI DE
AUBAGI O, TERI FLUNOMI DE
AUVI - Q, EPI NEPHRI NE
AVALI DE, HYDROCHLOROTHI AZI DE
AVAPRO, I RBESARTAN
CANTI L, MEPENZOLATE BROMI DE
CHI LDREN' S ALLEGRA ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S ALLEGRA HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CLAFORAN I N DEXTROSE 5%I N PLASTI C CONTAI NER, CEFOTAXI ME SODI UM
CLAFORAN, CEFOTAXI ME SODI UM
CLOMI D, CLOMI PHENE CI TRATE
DDAVP ( NEEDS NO REFRI GERATI ON) , DESMOPRESSI N ACETATE
DDAVP, DESMOPRESSI N ACETATE
DEMEROL, MEPERI DI NE HYDROCHLORI DE
DI ABETA, GLYBURI DE
DRI SDOL, ERGOCALCI FEROL
ELOXATI N, OXALI PLATI N
FERRLECI T, SODI UM FERRI C GLUCONATE COMPLEX
GAVI SCON, ALUMI NUM HYDROXI DE ( OTC)
HI PREX, METHENAMI NE HI PPURATE
KETEK, TELI THROMYCI N
LANTUS SOLOSTAR, I NSULI N GLARGI NE RECOMBI NANT
LANTUS, I NSULI N GLARGI NE RECOMBI NANT
LASI X, FUROSEMI DE
LOVENOX ( PRESERVATI VE FREE) , ENOXAPARI N SODI UM
LOVENOX, ENOXAPARI N SODI UM
MULTAQ, DRONEDARONE HYDROCHLORI DE
MYTELASE, AMBENONI UM CHLORI DE
NASACORT ALLERGY 24 HOUR, TRI AMCI NOLONE ACETONI DE ( OTC)
NI CODERM CQ, NI COTI NE ( OTC)
NORPRAMI N, DESI PRAMI NE HYDROCHLORI DE
PHI SOHEX, HEXACHLOROPHENE
PLAQUENI L, HYDROXYCHLOROQUI NE SULFATE
PLAVI X, CLOPI DOGREL BI SULFATE
PRI FTI N, RI FAPENTI NE
PRI MAQUI NE, PRI MAQUI NE PHOSPHATE
RI FADI N, RI FAMPI N
RI FAMATE, I SONI AZI D





















34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 121
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* SANOFI AVENTI S US LLC
RI FATER, I SONI AZI D
TAXOTERE, DOCETAXEL
TRENTAL, PENTOXI FYLLI NE
SANOFI PASTEUR I NC
* SANOFI PASTEUR I NC
SKLI CE, I VERMECTI N
SANTARUS
* SANTARUS I NC
UCERI S, BUDESONI DE
SANTEN
* SANTEN I NC
ALAMAST, PEMI ROLAST POTASSI UM
I QUI X, LEVOFLOXACI N
QUI XI N, LEVOFLOXACI N
SANTEN OY
* SANTEN OY
BETI MOL, TI MOLOL
SANTOS BI OTECH
* SANTOS BI OTECH I NDUSTRI ES I NC
ANASTROZOLE, ANASTROZOLE
SAVI ENT PHARMS
* SAVI ENT PHARMACEUTI CALS I NC
OXANDRI N, OXANDROLONE
SB PHARMCO
* SB PHARMCO PUERTO RI CO I NC
AVANDAMET, METFORMI N HYDROCHLORI DE
AVANDARYL, GLI MEPI RI DE
AVANDI A, ROSI GLI TAZONE MALEATE
COREG CR, CARVEDI LOL PHOSPHATE
SCHERI NG
* SCHERI NG CORP
ASMANEX TWI STHALER, MOMETASONE FUROATE
I NTEGRI LI N, EPTI FI BATI DE
NOXAFI L, POSACONAZOLE
REBETOL, RI BAVI RI N
SCHERI NG CORP
* SCHERI NG CORP
LOTRI SONE, BETAMETHASONE DI PROPI ONATE
SCHERI NG PLOUGH
* SCHERI NG PLOUGH HEALTHCARE PRODUCTS I NC
AFRI NOL, PSEUDOEPHEDRI NE SULFATE ( OTC)
CHI LDREN' S CLARI TI N, LORATADI NE ( OTC)
CHLOR- TRI METON, CHLORPHENI RAMI NE MALEATE ( OTC)
CHLOR- TRI METON, CHLORPHENI RAMI NE MALEATE ( OTC)
CLARI TI N HI VES RELI EF REDI TAB, LORATADI NE ( OTC)
CLARI TI N HI VES RELI EF, LORATADI NE ( OTC)
CLARI TI N REDI TABS, LORATADI NE ( OTC)
CLARI TI N, LORATADI NE ( OTC)
CLARI TI N- D 24 HOUR, LORATADI NE ( OTC)
CLARI TI N- D, LORATADI NE ( OTC)
DI SOPHROL, DEXBROMPHENI RAMI NE MALEATE ( OTC)
DRI XORAL PLUS, ACETAMI NOPHEN ( OTC)
DRI XORAL, DEXBROMPHENI RAMI NE MALEATE ( OTC)
GYNE- LOTRI MI N 3 COMBI NATI ON PACK, CLOTRI MAZOLE ( OTC)
GYNE- LOTRI MI N 3, CLOTRI MAZOLE ( OTC)
GYNE- LOTRI MI N COMBI NATI ON PACK, CLOTRI MAZOLE ( OTC)
GYNE- LOTRI MI N, CLOTRI MAZOLE ( OTC)
LOTRI MI N ULTRA, BUTENAFI NE HYDROCHLORI DE ( OTC)
MI RALAX, POLYETHYLENE GLYCOL 3350 ( OTC)
NASONEX, MOMETASONE FUROATE MONOHYDRATE
OCUCLEAR, OXYMETAZOLI NE HYDROCHLORI DE ( OTC)
SHADE UVAGUARD, AVOBENZONE ( OTC)
SCI ECURE PHARMA I NC

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 122
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* SCI ECURE PHARMA I NC
DORAL, QUAZEPAM
SCI EGEN PHARMS I NC
* SCI EGEN PHARMACEUTI CALS I NC
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
NEVI RAPI NE, NEVI RAPI NE
SCI OS LLC
* SCI OS LLC
NATRECOR, NESI RI TI DE RECOMBI NANT
SEBELA I RELAND LTD
* SEBELA I RELAND LTD
MI CORT- HC, HYDROCORTI SONE ACETATE
PRAMOSONE, HYDROCORTI SONE ACETATE
SECAN PHARMS
* SECAN PHARMACEUTI CALS I NC
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
SEPTODONT
* SEPTODONT I NC
BUPI VACAI NE HYDROCHLORI DE AND EPI NEPHRI NE, BUPI VACAI NE HYDROCHLORI DE
OCTOCAI NE, EPI NEPHRI NE
SEPTODONT HOLDI NG
* SEPTODONT HOLDI NG SAS
ORAVERSE, PHENTOLAMI NE MESYLATE
SEPTODONT I NC
* SEPTODONT I NC
PRI LOCAI NE HYDROCHLORI DE AND EPI NEPHRI NE BI TARTRATE, EPI NEPHRI NE BI TARTRATE
PRI LOCAI NE HYDROCHLORI DE, PRI LOCAI NE HYDROCHLORI DE
SETON PHARM
* SETON PHARMACEUTI CAL LLC
PEDI APRED, PREDNI SOLONE SODI UM PHOSPHATE
SHASUN CHEMS
* SHASUN CHEMI CALS AND DRUGS LTD
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
SHASUN USA
* SHASUN USA I NC
I BUPROFEN, I BUPROFEN
SHI ONOGI I NC
* SHI ONOGI I NC
DORI BAX, DORI PENEM
FURADANTI N, NI TROFURANTOI N
KEFLEX, CEPHALEXI N
MOXATAG, AMOXI CI LLI N
OSPHENA, OSPEMI FENE
PONSTEL, MEFENAMI C ACI D
ROBI NUL FORTE, GLYCOPYRROLATE
ROBI NUL, GLYCOPYRROLATE
SULAR, NI SOLDI PI NE
ULESFI A, BENZYL ALCOHOL
SHI RE
* SHI RE DEVELOPMENT I NC
ADDERALL XR 10, AMPHETAMI NE ASPARTATE
ADDERALL XR 15, AMPHETAMI NE ASPARTATE
ADDERALL XR 20, AMPHETAMI NE ASPARTATE
ADDERALL XR 25, AMPHETAMI NE ASPARTATE
ADDERALL XR 30, AMPHETAMI NE ASPARTATE
ADDERALL XR 5, AMPHETAMI NE ASPARTATE
CARBATROL, CARBAMAZEPI NE
I NTUNI V, GUANFACI NE HYDROCHLORI DE
LI ALDA, MESALAMI NE
PENTASA, MESALAMI NE
SHI RE DEVELOPMENT
* SHI RE DEVELOPMENT I NC
VYVANSE, LI SDEXAMFETAMI NE DI MESYLATE
SHI RE HUMAN GENETI C



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 123
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* SHI RE HUMAN GENETI C THERAPI ES I NC
VPRI V, VELAGLUCERASE ALFA
SHI RE LLC
* SHI RE DEVELOPMENT LLC
AGRYLI N, ANAGRELI DE HYDROCHLORI DE
FOSRENOL, LANTHANUM CARBONATE
SALURON, HYDROFLUMETHI AZI DE
SHI RE ORPHAN THERAP
* SHI RE ORPHAN THERAPI ES I NC
FI RAZYR, I CATI BANT ACETATE
SI GMA TAU
* SI GMA TAU PHARMACEUTI CALS I NC
ABELCET, AMPHOTERI CI N B
ADAGEN, PEGADEMASE BOVI NE
CARNI TOR SF, LEVOCARNI TI NE
CARNI TOR, LEVOCARNI TI NE
CYSTARAN, CYSTEAMI NE HYDROCHLORI DE
MATULANE, PROCARBAZI NE HYDROCHLORI DE
SI GMAPHARM LABS LLC
* SI GMAPHARM LABORATORI ES LLC
ADEFOVI R DI PI VOXI L, ADEFOVI R DI PI VOXI L
AMI LORI DE HYDROCHLORI DE, AMI LORI DE HYDROCHLORI DE
DI SULFI RAM, DI SULFI RAM
ERGOCALCI FEROL, ERGOCALCI FEROL
FLUCYTOSI NE, FLUCYTOSI NE
GRI SEOFULVI N, GRI SEOFULVI N, MI CROSI ZE
GRI SEOFULVI N, ULTRAMI CROSI ZE, GRI SEOFULVI N, ULTRAMI CROSI ZE
LI OTHYRONI NE SODI UM, LI OTHYRONI NE SODI UM
PROTRI PTYLI NE HYDROCHLORI DE, PROTRI PTYLI NE HYDROCHLORI DE
SODI UM PHENYLBUTYRATE, SODI UM PHENYLBUTYRATE
SI LARX
* SI LARX PHARMACEUTI CALS I NC
AMANTADI NE HYDROCHLORI DE, AMANTADI NE HYDROCHLORI DE
CETI RI ZI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
DOXEPI N HYDROCHLORI DE, DOXEPI N HYDROCHLORI DE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
HALOPERI DOL, HALOPERI DOL LACTATE
LEVETI RACETAM, LEVETI RACETAM
LORATADI NE, LORATADI NE ( OTC)
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
OXYBUTYNI N CHLORI DE, OXYBUTYNI N CHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
THEOPHYLLI NE, THEOPHYLLI NE
SI LARX PHARMS I NC
* SI LARX PHARMACEUTI CALS I NC
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
SI LVERGATE PHARMS
* SI LVERGATE PHARMACEUTI CALS I NC
EPANED KI T, ENALAPRI L MALEATE
SKI NMEDI CA
* SKI NMEDI CA I NC
VANI QA, EFLORNI THI NE HYDROCHLORI DE
SKYEPHARMA AG
* SKYEPHARMA AG
TRI GLI DE, FENOFI BRATE
SMI THKLI NE BEECHAM
* SMI THKLI NE BEECHAM
LOVAZA, OMEGA- 3- ACI D ETHYL ESTERS


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 124
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* SMI THKLI NE BEECHAM CORP DBA GLAXOSMI THKLI NE
ARRANON, NELARABI NE
COREG, CARVEDI LOL
TREXI MET, NAPROXEN SODI UM
TYKERB, LAPATI NI B DI TOSYLATE
SOAPCO
* SOAPCO I NC
BRI AN CARE, CHLORHEXI DI NE GLUCONATE ( OTC)
SOFGEN PHARMS
* SOFGEN PHARMACEUTI CALS LLC
PROGESTERONE, PROGESTERONE
SOMERSET
* SOMERSET PHARMACEUTI CALS I NC
ELDEPRYL, SELEGI LI NE HYDROCHLORI DE
EMSAM, SELEGI LI NE
SPEAR PHARMS
* SPEAR PHARMACEUTI CALS I NC
FLUOROURACI L, FLUOROURACI L
SPEAR PHARMS I NC
* SPEAR PHARMACEUTI CALS I NC
TRETI NOI N, TRETI NOI N
SPECTRUM PHARMS
* SPECTRUM PHARMACEUTI CALS I NC
FUSI LEV, LEVOLEUCOVORI N CALCI UM
STAND HOMEOPATH
* STANDARD HOMEOPATHI C CO
I VY BLOCK, BENTOQUATAM ( OTC)
STASON
* STASON I NDUSTRI AL CORP
ACYCLOVI R, ACYCLOVI R
CAPTOPRI L, CAPTOPRI L
SELEGI LI NE HYDROCHLORI DE, SELEGI LI NE HYDROCHLORI DE
STASON PHARMS
* STASON PHARMACEUTI CALS I NC
CYPROHEPTADI NE HYDROCHLORI DE, CYPROHEPTADI NE HYDROCHLORI DE
STERI PHARMA
* STERI PHARMA LLC
CEFAZOLI N SODI UM, CEFAZOLI N SODI UM
CEFTRI AXONE, CEFTRI AXONE SODI UM
CEFUROXI ME SODI UM, CEFUROXI ME SODI UM
STI PHARMA LLC
* STI PHARMA LLC
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
DEXAMETHASONE, DEXAMETHASONE
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
MYAMBUTOL, ETHAMBUTOL HYDROCHLORI DE
SULFATRI M PEDI ATRI C, SULFAMETHOXAZOLE
TRI ACI N- C, CODEI NE PHOSPHATE
STI EFEL
* STI EFEL LABORATORI ES I NC
DUAC, BENZOYL PEROXI DE
STI EFEL GSK
* STI EFEL A GSK CO
VELTI N, CLI NDAMYCI N PHOSPHATE
STI EFEL LABS I NC
* STI EFEL LABORATORI ES I NC
EXTI NA, KETOCONAZOLE
FABI OR, TAZAROTENE
OLUX, CLOBETASOL PROPI ONATE
SORI ATANE, ACI TRETI N
SORI LUX, CALCI POTRI ENE
VERDESO, DESONI DE
VUSI ON, MI CONAZOLE NI TRATE
STRI DES





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 125
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* STRI DES I NC
NEVI RAPI NE, NEVI RAPI NE
STRI DES ARCOLAB
* STRI DES ARCOLAB LI MI TED
FOSPHENYTOI N SODI UM, FOSPHENYTOI N SODI UM
STRI DES ARCOLAB LTD
* STRI DES ARCOLAB LTD
ACARBOSE, ACARBOSE
ADENOSI NE, ADENOSI NE
CEFTRI AXONE, CEFTRI AXONE SODI UM
ERGOCALCI FEROL, ERGOCALCI FEROL
ETOMI DATE, ETOMI DATE
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
I BUPROFEN AND DI PHENHYDRAMI NE HYDROCHLORI DE, DI PHENHYDRAMI NE HYDROCHLORI DE ( OTC)
MELOXI CAM, MELOXI CAM
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
SUCAMPO PHARMS
* SUCAMPO PHARMACEUTI CALS I NC
AMI TI ZA, LUBI PROSTONE
RESCULA, UNOPROSTONE I SOPROPYL
SUMMERS
* SUMMERS LABORATORI ES I NC
CROTAN, CROTAMI TON
SUN PHARM I NDS
* SUN PHARMACEUTI CAL I NDUSTRI ES LTD
CARBI DOPA AND LEVODOPA, CARBI DOPA
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
DESLORATADI NE, DESLORATADI NE
DESMOPRESSI N ACETATE, DESMOPRESSI N ACETATE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DOXORUBI CI N HYDROCHLORI DE, DOXORUBI CI N HYDROCHLORI DE
EPI NASTI NE HYDROCHLORI DE, EPI NASTI NE HYDROCHLORI DE
EXTENDED PHENYTOI N SODI UM, PHENYTOI N SODI UM
FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
METOPROLOL TARTRATE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
OCTREOTI DE ACETATE, OCTREOTI DE ACETATE
OLANZAPI NE, OLANZAPI NE
ONDANSETRON, ONDANSETRON
OXCARBAZEPI NE, OXCARBAZEPI NE
RI VASTI GMI NE TARTRATE, RI VASTI GMI NE TARTRATE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TI AGABI NE HYDROCHLORI DE, TI AGABI NE HYDROCHLORI DE
TORSEMI DE, TORSEMI DE
SUN PHARM I NDS ( I N)
* SUN PHARMACEUTI CAL I NDUSTRI ES LTD
CEPHALEXI N, CEPHALEXI N
EXTENDED PHENYTOI N SODI UM, PHENYTOI N SODI UM
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
ZONI SAMI DE, ZONI SAMI DE
SUN PHARM I NDS I NC
* SUN PHARMACEUTI CAL I NDUSTRI ES I NC
ERGOCALCI FEROL, ERGOCALCI FEROL
HYDROCODONE BI TARTRATE AND I BUPROFEN, HYDROCODONE BI TARTRATE
LI THI UM CARBONATE, LI THI UM CARBONATE
NI MODI PI NE, NI MODI PI NE
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
VALPROI C ACI D, VALPROI C ACI D
SUN PHARM I NDS LTD


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 126
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* SUN PHARMACEUTI CAL I NDUSTRI ES LTD
AZI THROMYCI N, AZI THROMYCI N
CARI SOPRODOL, CARI SOPRODOL
CETI RI ZI NE HYDROCHLORI DE AND PSEUDOEPHEDRI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
DESMOPRESSI N ACETATE, DESMOPRESSI N ACETATE
GABAPENTI N, GABAPENTI N
LETROZOLE, LETROZOLE
LEVETI RACETAM, LEVETI RACETAM
NARATRI PTAN, NARATRI PTAN
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
QUI NAPRI L HYDROCHLORI DE, QUI NAPRI L HYDROCHLORI DE
RI LUZOLE, RI LUZOLE
RI SPERI DONE, RI SPERI DONE
TAMSULOSI N HYDROCHLORI DE, TAMSULOSI N HYDROCHLORI DE
TESTOSTERONE CYPI ONATE, TESTOSTERONE CYPI ONATE
TOPI RAMATE, TOPI RAMATE
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
VALPROI C ACI D, VALPROI C ACI D
* SUN PHARMACEUTI CAL I NDUSTRI ES LTD.
ANASTROZOLE, ANASTROZOLE
SUN PHARMA GLOBAL
* SUN PHARMA GLOBAL FZE
AZELASTI NE HYDROCHLORI DE, AZELASTI NE HYDROCHLORI DE
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
CAFFEI NE CI TRATE, CAFFEI NE CI TRATE
CARBI DOPA, LEVODOPA AND ENTACAPONE, CARBI DOPA
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHLOROTHI AZI DE SODI UM, CHLOROTHI AZI DE SODI UM
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
DESMOPRESSI N ACETATE , DESMOPRESSI N ACETATE
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
DOCEFREZ, DOCETAXEL
DOXORUBI CI N HYDROCHLORI DE ( LI POSOMAL) , DOXORUBI CI N HYDROCHLORI DE
DULOXETI NE HYDROCHLORI DE, DULOXETI NE HYDROCHLORI DE
ENTACAPONE, ENTACAPONE
ESOMEPRAZOLE SODI UM, ESOMEPRAZOLE SODI UM
ESZOPI CLONE, ESZOPI CLONE
FI NASTERI DE, FI NASTERI DE
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
LANSOPRAZOLE, LANSOPRAZOLE
LEVETI RACETAM, LEVETI RACETAM
LEVOCETI RI ZI NE DI HYDROCHLORI DE, LEVOCETI RI ZI NE DI HYDROCHLORI DE
NALTREXONE HYDROCHLORI DE, NALTREXONE HYDROCHLORI DE
OXALI PLATI N, OXALI PLATI N
QUETI API NE FUMARATE, QUETI API NE FUMARATE
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
ZOLEDRONI C ACI D, ZOLEDRONI C ACI D
* SUN PHARMA GLOBAL I NC
ALENDRONATE SODI UM, ALENDRONATE SODI UM
ALFUZOSI N HYDROCHLORI DE, ALFUZOSI N HYDROCHLORI DE
ALPRAZOLAM, ALPRAZOLAM
AMI FOSTI NE, AMI FOSTI NE
AZELASTI NE HYDROCHLORI DE, AZELASTI NE HYDROCHLORI DE
BI CALUTAMI DE, BI CALUTAMI DE
CARBOPLATI N, CARBOPLATI N
FOSPHENYTOI N SODI UM, FOSPHENYTOI N SODI UM
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
LEUPROLI DE ACETATE, LEUPROLI DE ACETATE
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 127
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * S * *
* SUN PHARMA GLOBAL I NC
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
VECURONI UM BROMI DE, VECURONI UM BROMI DE
SUNEVA MEDCL
* SUNEVA MEDI CAL I NC
TRETI NOI N, TRETI NOI N
SUNOVI ON
* SUNOVI ON PHARMACEUTI CALS I NC
BROVANA, ARFORMOTEROL TARTRATE
XOPENEX HFA, LEVALBUTEROL TARTRATE
XOPENEX, LEVALBUTEROL HYDROCHLORI DE
SUNOVI ON PHARMS I NC
* SUNOVI ON PHARMACEUTI CALS I NC
APTI OM, ESLI CARBAZEPI NE ACETATE
LATUDA, LURASI DONE HYDROCHLORI DE
LUNESTA, ESZOPI CLONE
SUNSHI NE LAKE
* SUNSHI NE LAKE PHARMA CO LTD
ZI DOVUDI NE, ZI DOVUDI NE
SUNSTAR AMERI CAS
* SUNSTAR AMERI CAS I NC
PAROEX, CHLORHEXI DI NE GLUCONATE
SUPERNUS PHARMS
* SUPERNUS PHARMACEUTI CALS I NC
OXTELLAR XR, OXCARBAZEPI NE
TROKENDI XR, TOPI RAMATE
SUVEN LI FE
* SUVEN LI FE SCI ENCES LTD
MALATHI ON, MALATHI ON
SVADS HOLDI NGS SA
* SVADS HOLDI NGS SA
I BUPROFEN, I BUPROFEN ( OTC)
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
SVC PHARMA
* SVC PHARMA LP
DRONABI NOL, DRONABI NOL
SWEDI SH ORPHAN
* SWEDI SH ORPHAN BI OVI TRUM AB PUBL
ORFADI N, NI TI SI NONE
SYNTHON PHARMS
* SYNTHON PHARMACEUTI CALS I NC
LEVOCETI RI ZI NE DI HYDROCHLORI DE, LEVOCETI RI ZI NE DI HYDROCHLORI DE
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
TAMSULOSI N HYDROCHLORI DE, TAMSULOSI N HYDROCHLORI DE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
* * T * *
MEDI CI NES CO
* THE MEDI CI NES CO
ANGI OMAX, BI VALI RUDI N
CLEVI PREX, CLEVI DI PI NE
RI TEDOSE CORP
* THE RI TEDOSE CORP
ALBUTEROL SULFATE AND I PRATROPI UM BROMI DE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
I PRATROPI UM BROMI DE, I PRATROPI UM BROMI DE
TAKEDA GMBH
* TAKEDA GMBH
ALVESCO, CI CLESONI DE
OMNARI S, CI CLESONI DE
ZETONNA, CI CLESONI DE
TAKEDA PHARMS
* TAKEDA PHARMACEUTI CALS NORTH AMERI CA I NC







34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 128
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * T * *
* TAKEDA PHARMACEUTI CALS NORTH AMERI CA I NC
DEXI LANT, DEXLANSOPRAZOLE
TAKEDA PHARMS USA
* TAKEDA PHARMACEUTI CALS USA I NC
ACTOPLUS MET XR, METFORMI N HYDROCHLORI DE
ACTOPLUS MET, METFORMI N HYDROCHLORI DE
ACTOS, PI OGLI TAZONE HYDROCHLORI DE
BRI NTELLI X, VORTI OXETI NE HYDROBROMI DE
COLCRYS, COLCHI CI NE
DUETACT, GLI MEPI RI DE
KAZANO, ALOGLI PTI N BENZOATE
NESI NA, ALOGLI PTI N BENZOATE
OSENI , ALOGLI PTI N BENZOATE
PREVACI D, LANSOPRAZOLE
PREVPAC, AMOXI CI LLI N
ROZEREM, RAMELTEON
ULORI C, FEBUXOSTAT
TALON THERAP
* TALON THERAPEUTI CS I NC
MARQI BO KI T, VI NCRI STI NE SULFATE
TAMARANG
* TAMARANG SA
ROCURONI UM BROMI DE, ROCURONI UM BROMI DE
TARO
* TARO PHARMACEUTI CAL I NDUSTRI ES LTD
ACETAZOLAMI DE, ACETAZOLAMI DE
CARBAMAZEPI NE, CARBAMAZEPI NE
CARVEDI LOL, CARVEDI LOL
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CLOMI PRAMI NE HYDROCHLORI DE, CLOMI PRAMI NE HYDROCHLORI DE
ENALAPRI L MALEATE, ENALAPRI L MALEATE
ETODOLAC, ETODOLAC
EXTENDED PHENYTOI N SODI UM, PHENYTOI N SODI UM
FLUCONAZOLE, FLUCONAZOLE
FLUOROURACI L, FLUOROURACI L
GABAPENTI N, GABAPENTI N
HYDROCORTI SONE BUTYRATE, HYDROCORTI SONE BUTYRATE
I MI QUI MOD, I MI QUI MOD
KETOCONAZOLE, KETOCONAZOLE
LAMOTRI GI NE, LAMOTRI GI NE
LEVETI RACETAM, LEVETI RACETAM
LORATADI NE, LORATADI NE ( OTC)
MELOXI CAM, MELOXI CAM
METRONI DAZOLE, METRONI DAZOLE
NORTRI PTYLI NE HYDROCHLORI DE, NORTRI PTYLI NE HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
OXCARBAZEPI NE, OXCARBAZEPI NE
PHENYTOI N, PHENYTOI N
* TARO PHARMACEUTI CALS I NC
BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
CLOTRI MAZOLE, CLOTRI MAZOLE
CLOTRI MAZOLE, CLOTRI MAZOLE ( OTC)
DI FLORASONE DI ACETATE, DI FLORASONE DI ACETATE
FLUOCI NOLONE ACETONI DE, FLUOCI NOLONE ACETONI DE
FLUOCI NONI DE, FLUOCI NONI DE
HYDROCORTI SONE VALERATE, HYDROCORTI SONE VALERATE
MI CONAZOLE NI TRATE, MI CONAZOLE NI TRATE ( OTC)
NORTRI PTYLI NE HYDROCHLORI DE, NORTRI PTYLI NE HYDROCHLORI DE
TOPI CORT, DESOXI METASONE
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 129
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * T * *
* TARO PHARMACEUTI CALS I NC
WARFARI N SODI UM, WARFARI N SODI UM
* TARO PHARMACEUTI CALS USA I NC
ACETI C ACI D, ACETI C ACI D, GLACI AL
ALCLOMETASONE DI PROPI ONATE, ALCLOMETASONE DI PROPI ONATE
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
AMMONI UM LACTATE, AMMONI UM LACTATE
BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
CI CLOPI ROX, CI CLOPI ROX
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
CLOBETASOL PROPI ONATE ( EMOLLI ENT) , CLOBETASOL PROPI ONATE
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
CLORAZEPATE DI POTASSI UM, CLORAZEPATE DI POTASSI UM
CLOTRI MAZOLE AND BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
CLOTRI MAZOLE, CLOTRI MAZOLE
DERMABET, BETAMETHASONE VALERATE
DESONI DE, DESONI DE
DI FLORASONE DI ACETATE, DI FLORASONE DI ACETATE
ECONAZOLE NI TRATE, ECONAZOLE NI TRATE
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
FLO- PRED, PREDNI SOLONE ACETATE
FLUOCI NOLONE ACETONI DE, FLUOCI NOLONE ACETONI DE
FLUOCI NONI DE EMULSI FI ED BASE, FLUOCI NONI DE
FLUOCI NONI DE, FLUOCI NONI DE
FLUOROURACI L, FLUOROURACI L
GENTAMI CI N SULFATE, GENTAMI CI N SULFATE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
HALOBETASOL PROPI ONATE, HALOBETASOL PROPI ONATE
HYDROCORTI SONE AND ACETI C ACI D, ACETI C ACI D, GLACI AL
HYDROCORTI SONE, HYDROCORTI SONE
KETOZOLE, KETOCONAZOLE
LI DOCAI NE, LI DOCAI NE
LORATADI NE, LORATADI NE ( OTC)
MI CONAZOLE 3, MI CONAZOLE NI TRATE ( OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPI ROCI N, MUPI ROCI N
NYSTATI N AND TRI AMCI NOLONE ACETONI DE, NYSTATI N
NYSTATI N, NYSTATI N
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RI SPERI DONE, RI SPERI DONE
SULFACETAMI DE SODI UM, SULFACETAMI DE SODI UM
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE ( OTC)
TERCONAZOLE, TERCONAZOLE
TERI L, CARBAMAZEPI NE
TOPI CORT, DESOXI METASONE
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
TRI VAGI ZOLE 3, CLOTRI MAZOLE ( OTC)
U- CORT, HYDROCORTI SONE ACETATE
* TARO PHARMACEUTI CALS, I NC.
HYDROCORTI SONE VALERATE, HYDROCORTI SONE VALERATE
TOPI CORT, DESOXI METASONE
TARO PHARM I NDS
* TARO PHARMACEUTI CAL I NDUSTRI ES LTD
AMCI NONI DE, AMCI NONI DE
CARBAMAZEPI NE, CARBAMAZEPI NE
CI CLOPI ROX, CI CLOPI ROX
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
ENALAPRI L MALEATE AND HYDROCHLOROTHI AZI DE, ENALAPRI L MALEATE
ETODOLAC, ETODOLAC
HYDROCORTI SONE BUTYRATE, HYDROCORTI SONE BUTYRATE
LAMOTRI GI NE, LAMOTRI GI NE
LEVOCETI RI ZI NE DI HYDROCHLORI DE, LEVOCETI RI ZI NE DI HYDROCHLORI DE
TARO PHARMS I RELAND
* TARO PHARMACEUTI CALS I RELAND LTD




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 130
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * T * *
* TARO PHARMACEUTI CALS I RELAND LTD
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, SODI UM CHLORI DE
STERI LE WATER FOR I NJ ECTI ON I N PLASTI C CONTAI NER, STERI LE WATER FOR I NJ ECTI ON
TARO PHARMS NORTH
* TARO PHARMACEUTI CALS NORTH AMERI CA I NC
ACETAMI NOPHEN, ACETAMI NOPHEN ( OTC)
I NFANTS' FEVERALL, ACETAMI NOPHEN ( OTC)
OVI DE, MALATHI ON
TOPI CORT, DESOXI METASONE
TEDOR PHARM
* TEDOR PHARMA I NC
BENZPHETAMI NE HYDROCHLORI DE, BENZPHETAMI NE HYDROCHLORI DE
TEDOR PHARMA I NC
* TEDOR PHARMA I NC
ORPHENADRI NE CI TRATE, ORPHENADRI NE CI TRATE
TEI KOKU PHARMA USA
* TEI KOKU PHARMA USA I NC
LI DODERM, LI DOCAI NE
TEVA
* TEVA NEUROSCI ENCE I NC
AZI LECT, RASAGI LI NE MESYLATE
* TEVA PHARMACEUTI CALS USA I NC
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
ACYCLOVI R, ACYCLOVI R
ADI PEX- P, PHENTERMI NE HYDROCHLORI DE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
AMOXI CI LLI N AND CLAVULANATE POTASSI UM, AMOXI CI LLI N
AMOXI CI LLI N PEDI ATRI C, AMOXI CI LLI N
AMOXI CI LLI N, AMOXI CI LLI N
AMPHETAMI NE ASP AMPHETAMI NE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF, AMPHETAMI NE
ATENOLOL, ATENOLOL
AZI THROMYCI N, AZI THROMYCI N
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
BETA- VAL, BETAMETHASONE VALERATE
BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
BI CALUTAMI DE, BI CALUTAMI DE
BUSPI RONE HYDROCHLORI DE, BUSPI RONE HYDROCHLORI DE
CALCI TRI OL, CALCI TRI OL
CAPTOPRI L AND HYDROCHLOROTHI AZI DE, CAPTOPRI L
CAPTOPRI L, CAPTOPRI L
CARBI DOPA AND LEVODOPA, CARBI DOPA
CARVEDI LOL, CARVEDI LOL
CEFACLOR, CEFACLOR
CEFPROZI L, CEFPROZI L
CEFUROXI ME AXETI L, CEFUROXI ME AXETI L
CEPHALEXI N, CEPHALEXI N
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CHLORHEXI DI NE GLUCONATE, CHLORHEXI DI NE GLUCONATE
CI LOSTAZOL, CI LOSTAZOL
CI METI DI NE HYDROCHLORI DE, CI METI DI NE HYDROCHLORI DE
CI METI DI NE, CI METI DI NE
CLARI THROMYCI N, CLARI THROMYCI N
CLEMASTI NE FUMARATE, CLEMASTI NE FUMARATE
CLI NDAMYCI N HYDROCHLORI DE, CLI NDAMYCI N HYDROCHLORI DE
CLOMI PRAMI NE HYDROCHLORI DE, CLOMI PRAMI NE HYDROCHLORI DE
CLONAZEPAM, CLONAZEPAM
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
CLOTRI MAZOLE, CLOTRI MAZOLE
DI CLOFENAC POTASSI UM, DI CLOFENAC POTASSI UM
DI CLOXACI LLI N SODI UM, DI CLOXACI LLI N SODI UM
DI FLUNI SAL, DI FLUNI SAL
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE




34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 131
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * T * *
* TEVA PHARMACEUTI CALS USA I NC
DI SOPYRAMI DE PHOSPHATE, DI SOPYRAMI DE PHOSPHATE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DOXAZOSI N MESYLATE, DOXAZOSI N MESYLATE
ENALAPRI L MALEATE AND HYDROCHLOROTHI AZI DE, ENALAPRI L MALEATE
ENALAPRI L MALEATE, ENALAPRI L MALEATE
EPI TOL, CARBAMAZEPI NE
ESTAZOLAM, ESTAZOLAM
ETODOLAC, ETODOLAC
FAMOTI DI NE, FAMOTI DI NE
FAMOTI DI NE, FAMOTI DI NE ( OTC)
FENOFI BRATE ( MI CRONI ZED) , FENOFI BRATE
FENOFI BRATE, FENOFI BRATE
FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
FEXOFENADI NE HYDROCHLORI DE, FEXOFENADI NE HYDROCHLORI DE
FI NASTERI DE, FI NASTERI DE
FLUCONAZOLE, FLUCONAZOLE
FLUOCI NONI DE EMULSI FI ED BASE, FLUOCI NONI DE
FLUOCI NONI DE, FLUOCI NONI DE
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FLURBI PROFEN, FLURBI PROFEN
FLUVOXAMI NE MALEATE, FLUVOXAMI NE MALEATE
FOSI NOPRI L SODI UM, FOSI NOPRI L SODI UM
GALZI N, ZI NC ACETATE
GEMFI BROZI L, GEMFI BROZI L
GLI MEPI RI DE, GLI MEPI RI DE
GLYBURI DE ( MI CRONI ZED) , GLYBURI DE
GLYBURI DE, GLYBURI DE
HYDROCODONE BI TARTRATE AND I BUPROFEN, HYDROCODONE BI TARTRATE
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I SOSORBI DE MONONI TRATE, I SOSORBI DE MONONI TRATE
KETOCONAZOLE, KETOCONAZOLE
KETOPROFEN, KETOPROFEN
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
LAMOTRI GI NE, LAMOTRI GI NE
LEVOFLOXACI N, LEVOFLOXACI N
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE
LORATADI NE, LORATADI NE ( OTC)
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
LOVASTATI N, LOVASTATI N
MESALAMI NE, MESALAMI NE
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONI DAZOLE, METRONI DAZOLE
MEXI LETI NE HYDROCHLORI DE, MEXI LETI NE HYDROCHLORI DE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
MI RTAZAPI NE, MI RTAZAPI NE
MOEXI PRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
MOEXI PRI L HYDROCHLORI DE, MOEXI PRI L HYDROCHLORI DE
MUPI ROCI N, MUPI ROCI N
NABUMETONE, NABUMETONE
NAPROXEN SODI UM, NAPROXEN SODI UM
NAPROXEN, NAPROXEN
NEFAZODONE HYDROCHLORI DE, NEFAZODONE HYDROCHLORI DE
NEOMYCI N SULFATE, NEOMYCI N SULFATE
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
NI ZATI DI NE, NI ZATI DI NE
NORTRI PTYLI NE HYDROCHLORI DE, NORTRI PTYLI NE HYDROCHLORI DE
NYSTATI N, NYSTATI N
OFLOXACI N, OFLOXACI N
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 132
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * T * *
* TEVA PHARMACEUTI CALS USA I NC
ONDANSETRON, ONDANSETRON
ORAP, PI MOZI DE
OXAPROZI N, OXAPROZI N
OXYMORPHONE HYDROCHLORI DE, OXYMORPHONE HYDROCHLORI DE
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
PAROXETI NE HYDROCHLORI DE, PAROXETI NE HYDROCHLORI DE
PENI CI LLI N- VK, PENI CI LLI N V POTASSI UM
PI ROXI CAM, PI ROXI CAM
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM
PRELONE, PREDNI SOLONE
PURI NETHOL, MERCAPTOPURI NE
QUI NAPRI L HYDROCHLORI DE, QUI NAPRI L HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RI BAVI RI N, RI BAVI RI N
RI SPERI DONE, RI SPERI DONE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
ROSI GLI TAZONE MALEATE, ROSI GLI TAZONE MALEATE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SOTALOL HYDROCHLORI DE, SOTALOL HYDROCHLORI DE
SUCRALFATE, SUCRALFATE
SULFAMETHOXAZOLE AND TRI METHOPRI M DOUBLE STRENGTH, SULFAMETHOXAZOLE
TAMOXI FEN CI TRATE, TAMOXI FEN CI TRATE
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
TI CLOPI DI NE HYDROCHLORI DE, TI CLOPI DI NE HYDROCHLORI DE
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
TOLMETI N SODI UM, TOLMETI N SODI UM
TOPI RAMATE, TOPI RAMATE
TORSEMI DE, TORSEMI DE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
TRI METHOPRI M, TRI METHOPRI M
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
TEVA BRANDED PHARM
* TEVA BRANDED PHARMACEUTI CAL PRODUCTS R AND D I NC
CENESTI N, ESTROGENS, CONJ UGATED SYNTHETI C A
LOSEASONI QUE, ETHI NYL ESTRADI OL
MI RCETTE, DESOGESTREL
NORDETTE- 28, ETHI NYL ESTRADI OL
PLAN B ONE- STEP, LEVONORGESTREL ( OTC)
PLAN B, LEVONORGESTREL
PLAN B, LEVONORGESTREL ( OTC)
PROAI R HFA, ALBUTEROL SULFATE
PROGLYCEM, DI AZOXI DE
QNASL, BECLOMETHASONE DI PROPI ONATE
QUARTETTE, ETHI NYL ESTRADI OL
QVAR 40, BECLOMETHASONE DI PROPI ONATE
QVAR 80, BECLOMETHASONE DI PROPI ONATE
SEASONALE, ETHI NYL ESTRADI OL
SEASONI QUE, ETHI NYL ESTRADI OL
TEVA PARENTERAL
* TEVA PARENTERAL MEDI CI NES I NC
CALCI TRI OL, CALCI TRI OL
TEVA PHARMS
* TEVA PHARMACEUTI CALS USA
ALBUTEROL SULFATE AND I PRATROPI UM BROMI DE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALENDRONATE SODI UM, ALENDRONATE SODI UM
ALFUZOSI N HYDROCHLORI DE, ALFUZOSI N HYDROCHLORI DE
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
AMLODI PI NE BESYLATE AND BENAZEPRI L HYDROCHLORI DE, AMLODI PI NE BESYLATE
AMLODI PI NE, VALSARTAN AND HYDROCHLOROTHI AZI DE, AMLODI PI NE
ANASTROZOLE, ANASTROZOLE
AZI THROMYCI N, AZI THROMYCI N
BI SOPROLOL FUMARATE, BI SOPROLOL FUMARATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 133
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * T * *
* TEVA PHARMACEUTI CALS USA
BUDESONI DE, BUDESONI DE
CARBAMAZEPI NE, CARBAMAZEPI NE
CEFADROXI L, CEFADROXI L/ CEFADROXI L HEMI HYDRATE
CEFDI NI R, CEFDI NI R
CEFPROZI L, CEFPROZI L
CEFUROXI ME SODI UM, CEFUROXI ME SODI UM
CETI RI ZI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
CROMOLYN SODI UM, CROMOLYN SODI UM
DESMOPRESSI N ACETATE, DESMOPRESSI N ACETATE
DEXMETHYLPHENI DATE HYDROCHLORI DE, DEXMETHYLPHENI DATE HYDROCHLORI DE
DORZOLAMI DE HYDROCHLORI DE AND TI MOLOL MALEATE, DORZOLAMI DE HYDROCHLORI DE
DORZOLAMI DE HYDROCHLORI DE, DORZOLAMI DE HYDROCHLORI DE
DOXEPI N HYDROCHLORI DE, DOXEPI N HYDROCHLORI DE
ETHOSUXI MI DE, ETHOSUXI MI DE
FAMCI CLOVI R, FAMCI CLOVI R
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%I N PLASTI C CONTAI NER, FLUCONAZOLE
FLUVASTATI N SODI UM, FLUVASTATI N SODI UM
GABAPENTI N, GABAPENTI N
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
GEMCI TABI NE HYDROCHLORI DE, GEMCI TABI NE HYDROCHLORI DE
GLI PI ZI DE AND METFORMI N HYDROCHLORI DE, GLI PI ZI DE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
HALOPERI DOL, HALOPERI DOL LACTATE
HYDROCORTI SONE, HYDROCORTI SONE
HYDROXYCHLOROQUI NE SULFATE, HYDROXYCHLOROQUI NE SULFATE
I RBESARTAN, I RBESARTAN
LAMI VUDI NE AND ZI DOVUDI NE, LAMI VUDI NE
LANSOPRAZOLE, LANSOPRAZOLE
LEFLUNOMI DE, LEFLUNOMI DE
LETROZOLE, LETROZOLE
LEVETI RACETAM, LEVETI RACETAM
LEVOCETI RI ZI NE DI HYDROCHLORI DE, LEVOCETI RI ZI NE DI HYDROCHLORI DE
LI NEZOLI D, LI NEZOLI D
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
MEBENDAZOLE, MEBENDAZOLE
MEGESTROL ACETATE, MEGESTROL ACETATE
MELOXI CAM, MELOXI CAM
METHAZOLAMI DE, METHAZOLAMI DE
METHYLPHENI DATE HYDROCHLORI DE, METHYLPHENI DATE HYDROCHLORI DE
MONTELUKAST SODI UM, MONTELUKAST SODI UM
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
NARATRI PTAN, NARATRI PTAN HYDROCHLORI DE
OLANZAPI NE AND FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
OLANZAPI NE, OLANZAPI NE
OXALI PLATI N, OXALI PLATI N
PACLI TAXEL, PACLI TAXEL
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM
PRAZOSI N HYDROCHLORI DE, PRAZOSI N HYDROCHLORI DE
PREGABALI N, PREGABALI N
PROCHLORPERAZI NE MALEATE, PROCHLORPERAZI NE MALEATE
PROGESTERONE, PROGESTERONE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
QUI NI DI NE SULFATE, QUI NI DI NE SULFATE
QUI NI NE SULFATE, QUI NI NE SULFATE
RAMI PRI L, RAMI PRI L
RI SEDRONATE SODI UM, RI SEDRONATE SODI UM
RI ZATRI PTAN BENZOATE, RI ZATRI PTAN BENZOATE
ROCURONI UM BROMI DE, ROCURONI UM BROMI DE
SI LDENAFI L CI TRATE, SI LDENAFI L CI TRATE
SULFAMETHOXAZOLE AND TRI METHOPRI M SI NGLE STRENGTH, SULFAMETHOXAZOLE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 134
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * T * *
* TEVA PHARMACEUTI CALS USA
TAMOXI FEN CI TRATE, TAMOXI FEN CI TRATE
TAMSULOSI N HYDROCHLORI DE, TAMSULOSI N HYDROCHLORI DE
TESTOSTERONE, TESTOSTERONE
THEOPHYLLI NE, THEOPHYLLI NE
TRANDOLAPRI L, TRANDOLAPRI L
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
URSODI OL, URSODI OL
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
VALPROI C ACI D, VALPROI C ACI D
VANDAZOLE, METRONI DAZOLE
VARDENAFI L HYDROCHLORI DE, VARDENAFI L HYDROCHLORI DE
VORI CONAZOLE, VORI CONAZOLE
ZALEPLON, ZALEPLON
TEVA PHARMS USA
* TEVA PHARMACEUTI CALS USA
ACI TRETI N, ACI TRETI N
ADENOSI NE, ADENOSI NE
ALPROSTADI L, ALPROSTADI L
AMI KACI N SULFATE, AMI KACI N SULFATE
BLEOMYCI N SULFATE, BLEOMYCI N SULFATE
CARBOPLATI N, CARBOPLATI N
CEFTRI AXONE, CEFTRI AXONE SODI UM
CLARAVI S, I SOTRETI NOI N
COPAXONE, GLATI RAMER ACETATE
CYTOSAR- U, CYTARABI NE
DACARBAZI NE, DACARBAZI NE
DAUNORUBI CI N HYDROCHLORI DE, DAUNORUBI CI N HYDROCHLORI DE
DESMOPRESSI N ACETATE, DESMOPRESSI N ACETATE
DESVENLAFAXI NE FUMARATE, DESVENLAFAXI NE FUMARATE
DEXMETHYLPHENI DATE HYDROCHLORI DE, DEXMETHYLPHENI DATE HYDROCHLORI DE
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
DOXORUBI CI N HYDROCHLORI DE, DOXORUBI CI N HYDROCHLORI DE
DULOXETI NE HYDROCHLORI DE, DULOXETI NE HYDROCHLORI DE
ENALAPRI LAT, ENALAPRI LAT
EPI RUBI CI N HYDROCHLORI DE, EPI RUBI CI N HYDROCHLORI DE
EPOPROSTENOL SODI UM, EPOPROSTENOL SODI UM
ETOPOSI DE, ETOPOSI DE
FLUCONAZOLE I N SODI UM CHLORI DE 0. 9%, FLUCONAZOLE
FLUDARABI NE PHOSPHATE, FLUDARABI NE PHOSPHATE
FLUOROURACI L, FLUOROURACI L
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
HALOPERI DOL DECANOATE, HALOPERI DOL DECANOATE
HALOPERI DOL, HALOPERI DOL LACTATE
I DARUBI CI N HYDROCHLORI DE PFS, I DARUBI CI N HYDROCHLORI DE
I FOSFAMI DE, I FOSFAMI DE
I FOSFAMI DE/ MESNA KI T, I FOSFAMI DE
I RI NOTECAN HYDROCHLORI DE, I RI NOTECAN HYDROCHLORI DE
LANSOPRAZOLE, AMOXI CI LLI N AND CLARI THROMYCI N, AMOXI CI LLI N
LEUCOVORI N CALCI UM, LEUCOVORI N CALCI UM
LEUPROLI DE ACETATE, LEUPROLI DE ACETATE
LEVALBUTEROL HYDROCHLORI DE, LEVALBUTEROL HYDROCHLORI DE
LEVOCARNI TI NE, LEVOCARNI TI NE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MESNA, MESNA
METHYLPREDNI SOLONE ACETATE, METHYLPREDNI SOLONE ACETATE
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
MI TOXANTRONE HYDROCHLORI DE, MI TOXANTRONE HYDROCHLORI DE
NOREPI NEPHRI NE BI TARTRATE, NOREPI NEPHRI NE BI TARTRATE
OCTREOTI DE ACETATE, OCTREOTI DE ACETATE
PAMI DRONATE DI SODI UM, PAMI DRONATE DI SODI UM
PANCURONI UM BROMI DE, PANCURONI UM BROMI DE
PARI CALCI TOL, PARI CALCI TOL
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 135
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * T * *
* TEVA PHARMACEUTI CALS USA
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
PROPOFOL, PROPOFOL
RAMELTEON, RAMELTEON
SULFAMETHOXAZOLE AND TRI METHOPRI M, SULFAMETHOXAZOLE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TOBRAMYCI N SULFATE, TOBRAMYCI N SULFATE
TOBRAMYCI N, TOBRAMYCI N
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
VECURONI UM BROMI DE, VECURONI UM BROMI DE
VI NCRI STI NE SULFATE PFS, VI NCRI STI NE SULFATE
VI NORELBI NE TARTRATE, VI NORELBI NE TARTRATE
ZANOSAR, STREPTOZOCI N
* TEVA PHARMACEUTI CALS USA I NC
AMOXI CI LLI N AND CLAVULANATE POTASSI UM, AMOXI CI LLI N
CAPECI TABI NE, CAPECI TABI NE
ESTRADI OL AND NORETHI NDRONE ACETATE, ESTRADI OL
I MI QUI MOD, I MI QUI MOD
METRONI DAZOLE, METRONI DAZOLE
OXYBUTYNI N CHLORI DE, OXYBUTYNI N CHLORI DE
RABEPRAZOLE SODI UM, RABEPRAZOLE SODI UM
TRAZODONE HYDROCHLORI DE, TRAZODONE HYDROCHLORI DE
TEVA PHARMS USA I NC
* TEVA PHARMACEUTI CALS USA I NC
ADASUVE, LOXAPI NE
TEVA WOMENS
* TEVA WOMENS HEALTH I NC
ENJ UVI A, ESTROGENS, CONJ UGATED SYNTHETI C B
PARAGARD T 380A, COPPER
PREFEST, ESTRADI OL
REVI A, NALTREXONE HYDROCHLORI DE
ZEBETA, BI SOPROLOL FUMARATE
ZI AC, BI SOPROLOL FUMARATE
THE PHARMA NETWORK
* THE PHARMA NETWORK LLC
BENZONATATE, BENZONATATE
THE PHARMANETWORK
* THE PHARMANETWORK LLC
METHADONE HYDROCHLORI DE, METHADONE HYDROCHLORI DE
THEPHARMANETWORK LLC
* THEPHARMANETWORK LLC
THERMAZENE, SI LVER SULFADI AZI NE
THERAKOS
* THERAKOS I NC
UVADEX, METHOXSALEN
THERAVANCE I NC
* THERAVANCE I NC
VI BATI V, TELAVANCI N HYDROCHLORI DE
THREE RI VERS PHARMS
* THREE RI VERS PHARMACEUTI CALS LLC
ANASTROZOLE, ANASTROZOLE
RI BASPHERE, RI BAVI RI N
RI BAVI RI N, RI BAVI RI N
TOPOTECAN HYDROCHLORI DE, TOPOTECAN HYDROCHLORI DE
TOLMAR
* TOLMAR I NC
ADAPALENE, ADAPALENE
ATRI DOX, DOXYCYCLI NE HYCLATE
BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
CALCI POTRI ENE AND BETAMETHASONE DI PROPI ONATE, BETAMETHASONE DI PROPI ONATE
CALCI POTRI ENE, CALCI POTRI ENE
CI CLOPI ROX, CI CLOPI ROX
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
DI CLOFENAC SODI UM , DI CLOFENAC SODI UM
ERYTHROMYCI N AND BENZOYL PEROXI DE, BENZOYL PEROXI DE



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 136
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * T * *
* TOLMAR I NC
FLUTI CASONE PROPI ONATE, FLUTI CASONE PROPI ONATE
I MI QUI MOD, I MI QUI MOD
KETOCONAZOLE, KETOCONAZOLE
LEVETI RACETAM, LEVETI RACETAM
LI DOCAI NE AND PRI LOCAI NE, LI DOCAI NE
METRONI DAZOLE, METRONI DAZOLE
MOMETASONE FUROATE, MOMETASONE FUROATE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
TOLMAR THERAP
* TOLMAR THERAPEUTI CS I NC
ELI GARD, LEUPROLI DE ACETATE
TORPHARM
* TORPHARM I NC
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
TORRENT PHARM
* TORRENT PHARMA I NC
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
TORRENT PHARMS
* TORRENT PHARMACEUTI CALS LI MI TED
LEVOFLOXACI N, LEVOFLOXACI N
* TORRENT PHARMACEUTI CALS LTD
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
CARBAMAZEPI NE, CARBAMAZEPI NE
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
I SOSORBI DE MONONI TRATE, I SOSORBI DE MONONI TRATE
LAMOTRI GI NE, LAMOTRI GI NE
LEVETI RACETAM, LEVETI RACETAM
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
RI SPERI DONE, RI SPERI DONE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
TOPI RAMATE, TOPI RAMATE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
* TORRENT PHARMACEUTI CALS LTD.
ALFUZOSI N HYDROCHLORI DE, ALFUZOSI N HYDROCHLORI DE
TORRENT PHARMS LLC
* TORRENT PHARMACEUTI CALS LLC
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
OLANZAPI NE, OLANZAPI NE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
TORRENT PHARMS LTD
* TORRENT PHARMACEUTI CALS LTD
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
DULOXETI NE HYDROCHLORI DE, DULOXETI NE HYDROCHLORI DE
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
FELODI PI NE, FELODI PI NE
LAMOTRI GI NE, LAMOTRI GI NE
LEVETI RACETAM, LEVETI RACETAM
MONTELUKAST SODI UM, MONTELUKAST SODI UM
OLANZAPI NE, OLANZAPI NE
PI OGLI TAZONE HYDROCHLORI DE AND METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
QUETI API NE FUMARATE, QUETI API NE FUMARATE
RABEPRAZOLE SODI UM, RABEPRAZOLE SODI UM
SI LDENAFI L CI TRATE, SI LDENAFI L CI TRATE
TELMI SARTAN AND AMLODI PI NE, AMLODI PI NE BESYLATE
TRAZODONE HYDROCHLORI DE, TRAZODONE HYDROCHLORI DE
TRI S PHARMA I NC
* TRI S PHARMA I NC






34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 137
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * T * *
* TRI S PHARMA I NC
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S CETI RI ZI NE HYDROCHLORI DE HI VES RELI EF, CETI RI ZI NE HYDROCHLORI DE ( OTC)
DEXTROAMPHETAMI NE SULFATE, DEXTROAMPHETAMI NE SULFATE
DEXTROMETHORPHAN POLI STI REX, DEXTROMETHORPHAN POLI STI REX ( OTC)
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
HYDROCODONE POLI STI REX AND CHLORPHENI RAMI NE POLI STI REX, CHLORPHENI RAMI NE POLI STI REX
I BUPROFEN, I BUPROFEN ( OTC)
KARBI NAL ER, CARBI NOXAMI NE MALEATE
LEVETI RACETAM, LEVETI RACETAM
METHYLPHENI DATE HYDROCHLORI DE, METHYLPHENI DATE HYDROCHLORI DE
PROMETHAZI NE HYDROCHLORI DE AND CODEI NE PHOSPHATE, CODEI NE PHOSPHATE
PROMETHAZI NE HYDROCHLORI DE AND DEXTROMETHORPHAN HYDROBROMI DE, DEXTROMETHORPHAN
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
RI SPERI DONE, RI SPERI DONE
THEOPHYLLI NE, THEOPHYLLI NE
TWI PHARMS I NC
* TWI PHARMACEUTI CALS I NC
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
* * U * *
UCB I NC
* UCB I NC
KEPPRA XR, LEVETI RACETAM
KEPPRA, LEVETI RACETAM
LORTAB, ACETAMI NOPHEN
METADATE CD, METHYLPHENI DATE HYDROCHLORI DE
METADATE ER, METHYLPHENI DATE HYDROCHLORI DE
METHYLPHENI DATE HYDROCHLORI DE, METHYLPHENI DATE HYDROCHLORI DE
NEUPRO, ROTI GOTI NE
NI RAVAM, ALPRAZOLAM
PARCOPA, CARBI DOPA
TUSSI ONEX PENNKI NETI C, CHLORPHENI RAMI NE POLI STI REX
UNI RETI C, HYDROCHLOROTHI AZI DE
UNI VASC, MOEXI PRI L HYDROCHLORI DE
VI MPAT, LACOSAMI DE
XYZAL, LEVOCETI RI ZI NE DI HYDROCHLORI DE
ZAROXOLYN, METOLAZONE
UCLA BI OMEDI CAL
* UCLA BI OMEDI CAL CYCLOTRON
AMMONI A N 13, AMMONI A N- 13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F- 18
UCYCLYD
* UCYCLYD PHARMA I NC
AMMONUL, SODI UM BENZOATE
UNI CHEM
* UNI CHEM LABORATORI ES LTD
BI SOPROLOL FUMARATE AND HYDROCHLOROTHI AZI DE, BI SOPROLOL FUMARATE
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE HI VES, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
MELOXI CAM, MELOXI CAM
ZALEPLON, ZALEPLON
UNI CHEM LABS LTD
* UNI CHEM LABORATORI ES LI MI TED
DI VALPROEX SODI UM, DI VALPROEX SODI UM
* UNI CHEM LABORATORI ES LTD
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
LAMOTRI GI NE, LAMOTRI GI NE
TI ZANI DI NE HYDROCHLORI DE, TI ZANI DI NE HYDROCHLORI DE
TOPI RAMATE, TOPI RAMATE
UNI CHEM PHARMS ( USA)
* UNI CHEM PHARMACEUTI CALS ( USA) I NC
BI SOPROLOL FUMARATE, BI SOPROLOL FUMARATE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 138
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * U * *
UNI QUE PHARM LABS
* UNI QUE PHARMACEUTI CAL LABORATORI ES
ATENOLOL, ATENOLOL
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE
CETI RI ZI NE HYDROCHLORI DE HI VES, CETI RI ZI NE HYDROCHLORI DE
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
FLUCONAZOLE, FLUCONAZOLE
TI NI DAZOLE, TI NI DAZOLE
UNI TED BI OMEDCL
* UNI TED BI OMEDI CAL I NC
TERBUTALI NE SULFATE, TERBUTALI NE SULFATE
UNI TED GUARDI AN
* UNI TED GUARDI AN I NC
RENACI DI N, CI TRI C ACI D
UNI TED THERAP
* UNI TED THERAPEUTI CS CORP
ORENI TRAM, TREPROSTI NI L
REMODULI N, TREPROSTI NI L
TYVASO, TREPROSTI NI L
UNI V TX MD ANDERSON
* UNI V TEXAS MD ANDERSON CANCER CENTER
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F- 18
SODI UM FLUORI DE F- 18, SODI UM FLUORI DE F- 18
UPSHER SMI TH
* UPSHER SMI TH LABORATORI ES I NC
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
BETHANECHOL CHLORI DE, BETHANECHOL CHLORI DE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
DI VI GEL, ESTRADI OL
FORTI CAL, CALCI TONI N SALMON RECOMBI NANT
LAMOTRI GI NE, LAMOTRI GI NE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
MORPHI NE SULFATE, MORPHI NE SULFATE
NI ACOR, NI ACI N
NYSTATI N, NYSTATI N
ORVATEN, MI DODRI NE HYDROCHLORI DE
OXANDROLONE, OXANDROLONE
PACERONE, AMI ODARONE HYDROCHLORI DE
PENTOXI L, PENTOXI FYLLI NE
PREVALI TE, CHOLESTYRAMI NE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
SORI NE, SOTALOL HYDROCHLORI DE
TOPI RAMATE, TOPI RAMATE
ZALEPLON, ZALEPLON
UPSHER SMI TH LABS
* UPSHER SMI TH LABORATORI ES I NC
KLOR- CON M10, POTASSI UM CHLORI DE
KLOR- CON M15, POTASSI UM CHLORI DE
KLOR- CON M20, POTASSI UM CHLORI DE
UPSHER- SMI TH LABS
* UPSHER- SMI TH LABORATORI ES I NC
KLOR- CON, POTASSI UM CHLORI DE
US PHARMS HOLDI NGS I
* US PHARMACEUTI CALS HOLDI NGS I LLC
LOPRESSOR HCT, HYDROCHLOROTHI AZI DE
LOPRESSOR, METOPROLOL TARTRATE
LOTENSI N HCT, BENAZEPRI L HYDROCHLORI DE
LOTENSI N, BENAZEPRI L HYDROCHLORI DE
METHERGI NE, METHYLERGONOVI NE MALEATE
PARLODEL, BROMOCRI PTI NE MESYLATE
US WORLDMEDS
* US WORLDMEDS LLC
APOKYN, APOMORPHI NE HYDROCHLORI DE
( OTC)
( OTC)
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 139
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * U * *
* US WORLDMEDS LLC
DANTROLENE SODI UM, DANTROLENE SODI UM
USL PHARMA
* USL PHARMA I NC
AMANTADI NE HYDROCHLORI DE, AMANTADI NE HYDROCHLORI DE
BACLOFEN, BACLOFEN
BENZTROPI NE MESYLATE, BENZTROPI NE MESYLATE
CHLORDI AZEPOXI DE HYDROCHLORI DE, CHLORDI AZEPOXI DE HYDROCHLORI DE
CHLORPROMAZI NE HYDROCHLORI DE, CHLORPROMAZI NE HYDROCHLORI DE
ESTRADI OL, ESTRADI OL
FLUOXYMESTERONE, FLUOXYMESTERONE
J ANTOVEN, WARFARI N SODI UM
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
OXYBUTYNI N CHLORI DE, OXYBUTYNI N CHLORI DE
* * V * *
VALEANT
* VALEANT PHARMACEUTI CALS I NTERNATI ONAL
ANCOBON, FLUCYTOSI NE
BONTRI L PDM, PHENDI METRAZI NE TARTRATE
BONTRI L, PHENDI METRAZI NE TARTRATE
D. H. E. 45, DI HYDROERGOTAMI NE MESYLATE
DI ASTAT ACUDI AL, DI AZEPAM
DI ASTAT, DI AZEPAM
MI GRANAL, DI HYDROERGOTAMI NE MESYLATE
MOTOFEN, ATROPI NE SULFATE
MYSOLI NE, PRI MI DONE
PHRENI LI N FORTE, ACETAMI NOPHEN
PHRENI LI N WI TH CAFFEI NE AND CODEI NE, ACETAMI NOPHEN
VALEANT BERMUDA
* VALEANT I NTERNATI ONAL BERMUDA
APLENZI N, BUPROPI ON HYDROBROMI DE
BENZACLI N, BENZOYL PEROXI DE
CARAC, FLUOROURACI L
DERMATOP E EMOLLI ENT, PREDNI CARBATE
DERMATOP, PREDNI CARBATE
ELI DEL, PI MECROLI MUS
I SORDI L, I SOSORBI DE DI NI TRATE
KLARON, SULFACETAMI DE SODI UM
NORI TATE, METRONI DAZOLE
PENLAC, CI CLOPI ROX
RETI N- A, TRETI NOI N
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
XENAZI NE, TETRABENAZI NE
XERESE, ACYCLOVI R
ZOVI RAX, ACYCLOVI R
VALEANT I NTL
* VALEANT I NTERNATI ONAL BARBADOS SRL
ATI VAN, LORAZEPAM
CARDI ZEM CD, DI LTI AZEM HYDROCHLORI DE
CARDI ZEM LA, DI LTI AZEM HYDROCHLORI DE
CARDI ZEM, DI LTI AZEM HYDROCHLORI DE
DI CLOFENAC SODI UM, DI CLOFENAC SODI UM
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
FENOFI BRATE, FENOFI BRATE
NI FEDI PI NE, NI FEDI PI NE
PENTOXI FYLLI NE, PENTOXI FYLLI NE
RENOVA, TRETI NOI N
RETI N- A MI CRO, TRETI NOI N
RETI N- A, TRETI NOI N
TI AZAC, DI LTI AZEM HYDROCHLORI DE
ULTRAM ER, TRAMADOL HYDROCHLORI DE
VASERETI C, ENALAPRI L MALEATE
VASOTEC, ENALAPRI L MALEATE
WELLBUTRI N XL, BUPROPI ON HYDROCHLORI DE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 140
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * V * *
* VALEANT I NTERNATI ONAL SRL
BENZAMYCI N, BENZOYL PEROXI DE
VALEANT LUXEMBOURG
* VALEANT PHARMACEUTI CALS LUXEMBOURG SARL
BENZAMYCI N PAK, BENZOYL PEROXI DE
ERTACZO, SERTACONAZOLE NI TRATE
GRI FULVI N V, GRI SEOFULVI N, MI CROSI ZE
TARGRETI N, BEXAROTENE
VALEANT PHARM I NTL
* VALEANT PHARMACEUTI CALS I NTERNATI ONAL
8- MOP, METHOXSALEN
ANDROI D 10, METHYLTESTOSTERONE
ANDROI D 25, METHYLTESTOSTERONE
EFUDEX, FLUOROURACI L
LI BRI UM, CHLORDI AZEPOXI DE HYDROCHLORI DE
MESTI NON, PYRI DOSTI GMI NE BROMI DE
OXSORALEN, METHOXSALEN
TESTRED, METHYLTESTOSTERONE
VI RAZOLE, RI BAVI RI N
ZELAPAR, SELEGI LI NE HYDROCHLORI DE
VALEANT PHARMS
* VALEANT PHARMACEUTI CALS NORTH AMERI CA
MEPHYTON, PHYTONADI ONE
TENSI LON PRESERVATI VE FREE, EDROPHONI UM CHLORI DE
TENSI LON, EDROPHONI UM CHLORI DE
VALEANT PHARMS I NC
* VALEANT PHARMACEUTI CALS I NTERNATI ONAL I NC
VI SUDYNE, VERTEPORFI N
VALEANT PHARMS LLC
* VALEANT PHARMACEUTI CALS NORTH AMERI CA LLC
CAPI TAL AND CODEI NE, ACETAMI NOPHEN
MACUGEN, PEGAPTANI B SODI UM
MESTI NON, PYRI DOSTI GMI NE BROMI DE
TASMAR, TOLCAPONE
TI MOPTI C- XE, TI MOLOL MALEATE
VALI DUS PHARMS
* VALI DUS PHARMACEUTI CALS LLC
ROCALTROL, CALCI TRI OL
VALI DUS PHARMS I NC
* VALI DUS PHARMACEUTI CALS I NC
EQUETRO, CARBAMAZEPI NE
MARPLAN, I SOCARBOXAZI D
VANSEN PHARMA
* VANSEN PHARMA
SPECTRACEF, CEFDI TOREN PI VOXI L
VEROSCI ENCE
* VEROSCI ENCE LLC
CYCLOSET, BROMOCRI PTI NE MESYLATE
VERSAPHARM
* VERSAPHARM I NC
CI CLOPI ROX, CI CLOPI ROX
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
DEMECLOCYCLI NE HYDROCHLORI DE, DEMECLOCYCLI NE HYDROCHLORI DE
DESOXI METASONE, DESOXI METASONE
ERYTHROMYCI N, ERYTHROMYCI N
ETHOSUXI MI DE, ETHOSUXI MI DE
RI FAMPI N, RI FAMPI N
VERSAPHARM I NC
* VERSAPHARM I NC
RI FAMPI N, RI FAMPI N
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
* VERSAPHARM I NCORPORATED
TRANEXAMI C ACI D, TRANEXAMI C ACI D
VERTEX PHARMS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 141
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * V * *
* VERTEX PHARMACEUTI CALS I NC
I NCI VEK, TELAPREVI R
KALYDECO, I VACAFTOR
VESTI Q PHARMS
* VESTI Q PHARMACEUTI CALS I NC
ORAVI G, MI CONAZOLE
ZUPLENZ, ONDANSETRON
VI CURON
* VI CURON PHARMACEUTI CALS I NC
ERAXI S, ANI DULAFUNGI N
VI FOR FRESENI US
* VI FOR FRESENI US MEDI CAL CARE RENAL PHARMA FRANCE
VELPHORO, SUCROFERRI C OXYHYDROXI DE
VI I V HLTHCARE
* VI I V HEALTHCARE CO
COMBI VI R, LAMI VUDI NE
EPI VI R, LAMI VUDI NE
EPZI COM, ABACAVI R SULFATE
LEXI VA, FOSAMPRENAVI R CALCI UM
RESCRI PTOR, DELAVI RDI NE MESYLATE
RETROVI R, ZI DOVUDI NE
SELZENTRY, MARAVI ROC
TI VI CAY, DOLUTEGRAVI R SODI UM
TRI ZI VI R, ABACAVI R SULFATE
ZI AGEN, ABACAVI R SULFATE
VI NTAGE
* VI NTAGE PHARMACEUTI CALS LLC
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
ACETI C ACI D, ACETI C ACI D, GLACI AL
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALPRAZOLAM, ALPRAZOLAM
AMANTADI NE HYDROCHLORI DE, AMANTADI NE HYDROCHLORI DE
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
BENZTROPI NE MESYLATE, BENZTROPI NE MESYLATE
CETI RI ZI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
FOLI C ACI D, FOLI C ACI D
GLI MEPI RI DE, GLI MEPI RI DE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCORTI SONE AND ACETI C ACI D, ACETI C ACI D, GLACI AL
HYDROCORTI SONE, HYDROCORTI SONE
LI DOCAI NE HYDROCHLORI DE VI SCOUS, LI DOCAI NE HYDROCHLORI DE
LI DOCAI NE HYDROCHLORI DE, LI DOCAI NE HYDROCHLORI DE
LI SI NOPRI L, LI SI NOPRI L
NYSTATI N, NYSTATI N
PHENYLEPHRI NE HYDROCHLORI DE AND PROMETHAZI NE HYDROCHLORI DE, PHENYLEPHRI NE
PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
PREDNI SOLONE, PREDNI SOLONE
PROMETH HYDROCHLORI DE, PHENYLEPHRI NE HYDROCHLORI DE W/ CODEI NE PHOSPHATE, CODEI NE
PROMETHAZI NE DM, DEXTROMETHORPHAN HYDROBROMI DE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
PROMETHAZI NE WI TH CODEI NE, CODEI NE PHOSPHATE
RI SPERI DONE, RI SPERI DONE
SPI RONOLACTONE, SPI RONOLACTONE
SULFAMETHOXAZOLE AND TRI METHOPRI M, SULFAMETHOXAZOLE
TRAZODONE HYDROCHLORI DE, TRAZODONE HYDROCHLORI DE
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
VALPROI C ACI D, VALPROI C ACI D
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
VI NTAGE PHARMS
* VI NTAGE PHARMACEUTI CALS
DI SULFI RAM, DI SULFI RAM
GI LDAGI A, ETHI NYL ESTRADI OL

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 142
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * V * *
* VI NTAGE PHARMACEUTI CALS
GRI SEOFULVI N, GRI SEOFULVI N, MI CROSI ZE
LEVETI RACETAM, LEVETI RACETAM
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
* VI NTAGE PHARMACEUTI CALS I NC
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
ALLOPURI NOL, ALLOPURI NOL
AMI TRI PTYLI NE HYDROCHLORI DE, AMI TRI PTYLI NE HYDROCHLORI DE
BACLOFEN, BACLOFEN
BUTALBI TAL, ACETAMI NOPHEN AND CAFFEI NE, ACETAMI NOPHEN
BUTALBI TAL, ACETAMI NOPHEN, CAFFEI NE AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
CARI SOPRODOL, CARI SOPRODOL
CLONAZEPAM, CLONAZEPAM
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
DEXAMETHASONE, DEXAMETHASONE
DI AZEPAM, DI AZEPAM
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
FUROSEMI DE, FUROSEMI DE
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
HYDROCODONE BI TARTRATE AND I BUPROFEN, HYDROCODONE BI TARTRATE
HYDROCORTI SONE, HYDROCORTI SONE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
I BUPROFEN, I BUPROFEN
I BUPROFEN, I BUPROFEN ( OTC)
I SOSORBI DE MONONI TRATE, I SOSORBI DE MONONI TRATE
LACTULOSE, LACTULOSE
LEVETI RACETAM, LEVETI RACETAM
LORAZEPAM, LORAZEPAM
MECLI ZI NE HYDROCHLORI DE, MECLI ZI NE HYDROCHLORI DE
MEPERI DI NE HYDROCHLORI DE, MEPERI DI NE HYDROCHLORI DE
METHOCARBAMOL, METHOCARBAMOL
METHYLPREDNI SOLONE, METHYLPREDNI SOLONE
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
NYSTATI N, NYSTATI N
OXYBUTYNI N CHLORI DE, OXYBUTYNI N CHLORI DE
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
PERPHENAZI NE, PERPHENAZI NE
PHENTERMI NE HYDROCHLORI DE, PHENTERMI NE HYDROCHLORI DE
PREDNI SONE, PREDNI SONE
PRI MI DONE, PRI MI DONE
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
PROPAFENONE HYDROCHLORI DE, PROPAFENONE HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
SOTALOL HYDROCHLORI DE, SOTALOL HYDROCHLORI DE
SULFASALAZI NE, SULFASALAZI NE
TORSEMI DE, TORSEMI DE
TRI HEXYPHENI DYL HYDROCHLORI DE, TRI HEXYPHENI DYL HYDROCHLORI DE
VI NTAGE PHARMS LLC
* VI NTAGE PHARMACEUTI CALS LLC
CYCLAFEM 1/ 35, ETHI NYL ESTRADI OL
CYCLAFEM 7/ 7/ 7, ETHI NYL ESTRADI OL
EMOQUETTE, DESOGESTREL
FELODI PI NE, FELODI PI NE
GI LDESS FE 1. 5/ 30, ETHI NYL ESTRADI OL
GI LDESS FE 1/ 20, ETHI NYL ESTRADI OL
LETROZOLE, LETROZOLE
LEVETI RACETAM, LEVETI RACETAM
MONTELUKAST SODI UM, MONTELUKAST SODI UM
MORPHI NE SULFATE, MORPHI NE SULFATE
MYCOPHENOLATE MOFETI L, MYCOPHENOLATE MOFETI L
MYZI LRA, ETHI NYL ESTRADI OL
ORSYTHI A, ETHI NYL ESTRADI OL
PERCOCET, ACETAMI NOPHEN
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 143
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * V * *
* VI NTAGE PHARMACEUTI CALS LLC
PREVI FEM, ETHI NYL ESTRADI OL
TRI - PREVI FEM, ETHI NYL ESTRADI OL
ZYDONE, ACETAMI NOPHEN
VI ROPHARMA
* VI ROPHARMA I NC
VANCOCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
VI RTUS PHARM
* VI RTUS PHARMACEUTI CAL I NC
ACARBOSE , ACARBOSE
VI STA PHARMS
* VI STA PHARMACEUTI CALS I NC
SULFAMETHOXAZOLE AND TRI METHOPRI M, SULFAMETHOXAZOLE
VI STAPHARM
* VI STAPHARM I NC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
LACTULOSE, LACTULOSE
METHADONE HYDROCHLORI DE, METHADONE HYDROCHLORI DE
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
MORPHI NE SULFATE, MORPHI NE SULFATE
NYSTATI N, NYSTATI N
OXYCODONE HYDROCHLORI DE, OXYCODONE HYDROCHLORI DE
PHENYTOI N, PHENYTOI N
VI VI MED LABS
* VI VI MED LABS ALATHUR PRI VATE LTD
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
VI VUS
* VI VUS I NC
QSYMI A, PHENTERMI NE HYDROCHLORI DE
STENDRA, AVANAFI L
* * W * *
WARNER CHI LCOTT
* WARNER CHI LCOTT CO LLC
LO MI NASTRI N FE, ETHI NYL ESTRADI OL
NORETHI NDRONE AND ETHI NYL ESTRADI OL AND FERROUS FUMARATE, ETHI NYL ESTRADI OL
* WARNER CHI LCOTT I NC
LOESTRI N 24 FE, ETHI NYL ESTRADI OL
LOESTRI N FE 1/ 20, ETHI NYL ESTRADI OL
WARNER CHI LCOTT LLC
* WARNER CHI LCOTT CO LLC
ACTONEL, RI SEDRONATE SODI UM
ASACOL HD, MESALAMI NE
ASACOL, MESALAMI NE
ATELVI A, RI SEDRONATE SODI UM
CHOLEDYL SA, OXTRI PHYLLI NE
DELZI COL, MESALAMI NE
ENABLEX, DARI FENACI N HYDROBROMI DE
ESTROSTEP FE, ETHI NYL ESTRADI OL
FEMCON FE, ETHI NYL ESTRADI OL
FEMHRT, ETHI NYL ESTRADI OL
FEMTRACE, ESTRADI OL ACETATE
LO LOESTRI N FE, ETHI NYL ESTRADI OL
LOESTRI N 21 1. 5/ 30, ETHI NYL ESTRADI OL
LOESTRI N 21 1/ 20, ETHI NYL ESTRADI OL
LOESTRI N FE 1. 5/ 30, ETHI NYL ESTRADI OL
MI NASTRI N 24 FE, ETHI NYL ESTRADI OL
OVCON- 35, ETHI NYL ESTRADI OL
SARAFEM, FLUOXETI NE HYDROCHLORI DE
WARNER CHI LCOTT US
* WARNER CHI LCOTT US LLC
ESTRACE, ESTRADI OL

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 144
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * W * *
WARNER I RELAND
* WARNER CHI LCOTT I RELAND LTD
FEMRI NG, ESTRADI OL ACETATE
WATSON LABS
* WATSON LABORATORI ES
ACETAMI NOPHEN AND PENTAZOCI NE HYDROCHLORI DE, ACETAMI NOPHEN
ANASTROZOLE, ANASTROZOLE
FOLI C ACI D, FOLI C ACI D
LEVONORGESTREL AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
MI CROGESTI N 1. 5/ 30, ETHI NYL ESTRADI OL
MI CROGESTI N 1/ 20, ETHI NYL ESTRADI OL
MI CROGESTI N FE 1. 5/ 30, ETHI NYL ESTRADI OL
MI CROGESTI N FE 1/ 20, ETHI NYL ESTRADI OL
NORCO, ACETAMI NOPHEN
NORETHI NDRONE ACETATE AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
OXAPROZI N, OXAPROZI N
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
PROPAFENONE HYDROCHLORI DE, PROPAFENONE HYDROCHLORI DE
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
* WATSON LABORATORI ES I NC
ACARBOSE, ACARBOSE
ACEBUTOLOL HYDROCHLORI DE, ACEBUTOLOL HYDROCHLORI DE
ACETOHEXAMI DE, ACETOHEXAMI DE
AFEDI TAB CR, NI FEDI PI NE
ALBUTEROL SULFATE AND I PRATROPI UM BROMI DE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALENDRONATE SODI UM, ALENDRONATE SODI UM
ALLOPURI NOL, ALLOPURI NOL
ALORA, ESTRADI OL
AMLODI PI NE BESYLATE AND BENAZEPRI L HYDROCHLORI DE, AMLODI PI NE BESYLATE
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
AMOXAPI NE, AMOXAPI NE
ANDRODERM, TESTOSTERONE
ATENOLOL AND CHLORTHALI DONE, ATENOLOL
BACLOFEN, BACLOFEN
BI SOPROLOL FUMARATE AND HYDROCHLOROTHI AZI DE, BI SOPROLOL FUMARATE
BREVI CON 28- DAY, ETHI NYL ESTRADI OL
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
BUSPI RONE HYDROCHLORI DE, BUSPI RONE HYDROCHLORI DE
BUTALBI TAL, ACETAMI NOPHEN AND CAFFEI NE, ACETAMI NOPHEN
BUTALBI TAL, ASPI RI N, CAFFEI NE, AND CODEI NE PHOSPHATE, ASPI RI N
CABERGOLI NE, CABERGOLI NE
CAPTOPRI L, CAPTOPRI L
CARBOPLATI N, CARBOPLATI N
CARI SOPRODOL, CARI SOPRODOL
CHLORDI AZEPOXI DE HYDROCHLORI DE, CHLORDI AZEPOXI DE HYDROCHLORI DE
CHLORZOXAZONE, CHLORZOXAZONE
CI METI DI NE, CI METI DI NE ( OTC)
CI PROFLOXACI N HYDROCHLORI DE, CI PROFLOXACI N HYDROCHLORI DE
CI TALOPRAM HYDROBROMI DE, CI TALOPRAM HYDROBROMI DE
CLI NDAMYCI N HYDROCHLORI DE, CLI NDAMYCI N HYDROCHLORI DE
CLONAZEPAM, CLONAZEPAM
CLONI DI NE HYDROCHLORI DE, CLONI DI NE HYDROCHLORI DE
CLORAZEPATE DI POTASSI UM, CLORAZEPATE DI POTASSI UM
COL- PROBENECI D, COLCHI CI NE
CRI NONE, PROGESTERONE
CROMOLYN SODI UM, CROMOLYN SODI UM
CYCLOBENZAPRI NE HYDROCHLORI DE, CYCLOBENZAPRI NE HYDROCHLORI DE
CYCLOSPORI NE, CYCLOSPORI NE
DEFEROXAMI NE MESYLATE, DEFEROXAMI NE MESYLATE
DESMOPRESSI N ACETATE, DESMOPRESSI N ACETATE
DESOGESTREL AND ETHI NYL ESTRADI OL, DESOGESTREL
DI AZEPAM, DI AZEPAM



34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 145
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * W * *
* WATSON LABORATORI ES I NC
DI CYCLOMI NE HYDROCHLORI DE, DI CYCLOMI NE HYDROCHLORI DE
DI LACOR XR, DI LTI AZEM HYDROCHLORI DE
DI PYRI DAMOLE, DI PYRI DAMOLE
DI SOPYRAMI DE PHOSPHATE, DI SOPYRAMI DE PHOSPHATE
DOBUTAMI NE HYDROCHLORI DE, DOBUTAMI NE HYDROCHLORI DE
DOXAPRAM HYDROCHLORI DE, DOXAPRAM HYDROCHLORI DE
DOXYCYCLI NE, DOXYCYCLI NE
DROSPI RENONE AND ETHI NYL ESTRADI OL, DROSPI RENONE
ENALAPRI L MALEATE, ENALAPRI L MALEATE
ERGOLOI D MESYLATES, ERGOLOI D MESYLATES
ESTAZOLAM, ESTAZOLAM
ESTRADI OL CYPI ONATE, ESTRADI OL CYPI ONATE
ESTRADI OL, ESTRADI OL
ESTROPI PATE, ESTROPI PATE
FAMOTI DI NE, FAMOTI DI NE ( OTC)
FENTANYL CI TRATE, FENTANYL CI TRATE
FENTANYL- 100, FENTANYL
FENTANYL- 25, FENTANYL
FENTANYL- 50, FENTANYL
FENTANYL- 75, FENTANYL
FLURAZEPAM HYDROCHLORI DE, FLURAZEPAM HYDROCHLORI DE
FOSI NOPRI L SODI UM, FOSI NOPRI L SODI UM
FUROSEMI DE, FUROSEMI DE
GABAPENTI N, GABAPENTI N
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
GELNI QUE, OXYBUTYNI N CHLORI DE
GEMFI BROZI L, GEMFI BROZI L
GLI MEPI RI DE, GLI MEPI RI DE
GLI PI ZI DE, GLI PI ZI DE
GUANFACI NE HYDROCHLORI DE, GUANFACI NE HYDROCHLORI DE
HYDRALAZI NE HYDROCHLORI DE, HYDRALAZI NE HYDROCHLORI DE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
HYDROXOCOBALAMI N, HYDROXOCOBALAMI N
HYDROXYCHLOROQUI NE SULFATE, HYDROXYCHLOROQUI NE SULFATE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
HYDROXYZI NE PAMOATE, HYDROXYZI NE PAMOATE
I BUPROFEN, I BUPROFEN
I BUPROFEN, I BUPROFEN ( OTC)
I NDAPAMI DE, I NDAPAMI DE
I PRATROPI UM BROMI DE, I PRATROPI UM BROMI DE
I SRADI PI NE, I SRADI PI NE
LABETALOL HYDROCHLORI DE, LABETALOL HYDROCHLORI DE
LAMOTRI GI NE, LAMOTRI GI NE
LEVONORGESTREL AND ETHI NYL ESTRADI OL AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
LEVONORGESTREL AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL ( OTC)
LEVORA 0. 15/ 30- 28, ETHI NYL ESTRADI OL
LI SI NOPRI L, LI SI NOPRI L
LORAZEPAM, LORAZEPAM
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
LOW- OGESTREL- 21, ETHI NYL ESTRADI OL
LOW- OGESTREL- 28, ETHI NYL ESTRADI OL
LOXAPI NE SUCCI NATE, LOXAPI NE SUCCI NATE
MECLI ZI NE HYDROCHLORI DE, MECLI ZI NE HYDROCHLORI DE
MEPERI DI NE HYDROCHLORI DE PRESERVATI VE FREE, MEPERI DI NE HYDROCHLORI DE
MEPERI DI NE HYDROCHLORI DE, MEPERI DI NE HYDROCHLORI DE
MEPI VACAI NE HYDROCHLORI DE, MEPI VACAI NE HYDROCHLORI DE
MEPROBAMATE, MEPROBAMATE
METHOCARBAMOL, METHOCARBAMOL
METHYLDOPA, METHYLDOPA
METHYLPHENI DATE HYDROCHLORI DE, METHYLPHENI DATE HYDROCHLORI DE
METHYLPREDNI SOLONE, METHYLPREDNI SOLONE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 146
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * W * *
* WATSON LABORATORI ES I NC
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONI DAZOLE, METRONI DAZOLE
MI CROZI DE, HYDROCHLOROTHI AZI DE
MI NOCYCLI NE HYDROCHLORI DE, MI NOCYCLI NE HYDROCHLORI DE
MI NOXI DI L, MI NOXI DI L
MI RTAZAPI NE, MI RTAZAPI NE
MORPHI NE SULFATE, MORPHI NE SULFATE
NABUMETONE, NABUMETONE
NALOXONE HYDROCHLORI DE AND PENTAZOCI NE HYDROCHLORI DE, NALOXONE HYDROCHLORI DE
NAPROXEN SODI UM, NAPROXEN SODI UM
NAPROXEN, NAPROXEN
NATEGLI NI DE, NATEGLI NI DE
NEOMYCI N AND POLYMYXI N B SULFATE, NEOMYCI N SULFATE
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
NI COTI NE POLACRI LEX, NI COTI NE POLACRI LEX ( OTC)
NI ZATI DI NE, NI ZATI DI NE
NORCO, ACETAMI NOPHEN
NORETHI N 1/ 35E- 21, ETHI NYL ESTRADI OL
NORETHI N 1/ 35E- 28, ETHI NYL ESTRADI OL
NORETHI NDRONE AND ETHI NYL ESTRADI OL ( 10/ 11) , ETHI NYL ESTRADI OL
NORETHI NDRONE AND ETHI NYL ESTRADI OL ( 7/ 14) , ETHI NYL ESTRADI OL
NORETHI NDRONE AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
NORGESTI MATE AND ETHI NYL ESTRADI OL, ETHI NYL ESTRADI OL
NORI NYL 1+35 21- DAY, ETHI NYL ESTRADI OL
NORI NYL 1+35 28- DAY, ETHI NYL ESTRADI OL
NORI NYL 1+50 28- DAY, MESTRANOL
NORTRI PTYLI NE HYDROCHLORI DE, NORTRI PTYLI NE HYDROCHLORI DE
OGESTREL 0. 5/ 50- 28, ETHI NYL ESTRADI OL
ORPHENADRI NE CI TRATE, ORPHENADRI NE CI TRATE
OXAZEPAM, OXAZEPAM
OXYCODONE AND ACETAMI NOPHEN, ACETAMI NOPHEN
OXYCODONE AND ASPI RI N, ASPI RI N
OXYCODONE AND ASPI RI N, ASPI RI N
OXYCODONE HYDROCHLORI DE AND I BUPROFEN, I BUPROFEN
PENTAMI DI NE I SETHI ONATE, PENTAMI DI NE I SETHI ONATE
PENTOXI FYLLI NE, PENTOXI FYLLI NE
PI ROXI CAM, PI ROXI CAM
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM
PREDNI SOLONE, PREDNI SOLONE
PREDNI SONE, PREDNI SONE
PRI MI DONE, PRI MI DONE
PROBENECI D, PROBENECI D
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
QUASENSE, ETHI NYL ESTRADI OL
QUI NI DI NE GLUCONATE, QUI NI DI NE GLUCONATE
QUI NI DI NE SULFATE, QUI NI DI NE SULFATE
RAMI PRI L, RAMI PRI L
RAPAFLO, SI LODOSI N
RI SPERI DONE, RI SPERI DONE
RI VASTI GMI NE TARTRATE, RI VASTI GMI NE TARTRATE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SI MVASTATI N, SI MVASTATI N
SPI RONOLACTONE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
SULFASALAZI NE, SULFASALAZI NE
SULI NDAC, SULI NDAC
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TACROLI MUS, TACROLI MUS
TAMOXI FEN CI TRATE, TAMOXI FEN CI TRATE
TELMI SARTAN, TELMI SARTAN
TEMAZEPAM, TEMAZEPAM
TESTOSTERONE CYPI ONATE, TESTOSTERONE CYPI ONATE


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 147
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * W * *
* WATSON LABORATORI ES I NC
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
TETRACYCLI NE HYDROCHLORI DE, TETRACYCLI NE HYDROCHLORI DE
THI AMI NE HYDROCHLORI DE, THI AMI NE HYDROCHLORI DE
THI OTHI XENE, THI OTHI XENE
TOPI RAMATE, TOPI RAMATE
TRAMADOL HYDROCHLORI DE AND ACETAMI NOPHEN, ACETAMI NOPHEN
TRANDOLAPRI L, TRANDOLAPRI L
TRAZODONE HYDROCHLORI DE, TRAZODONE HYDROCHLORI DE
TRELSTAR, TRI PTORELI N PAMOATE
TRI - NORI NYL 28- DAY, ETHI NYL ESTRADI OL
TRI AMTERENE AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
TRI AZOLAM, TRI AZOLAM
TRI HEXYPHENI DYL HYDROCHLORI DE, TRI HEXYPHENI DYL HYDROCHLORI DE
TRI METHOPRI M, TRI METHOPRI M
TRI VORA- 28, ETHI NYL ESTRADI OL
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
VANCOMYCI N HYDROCHLORI DE, VANCOMYCI N HYDROCHLORI DE
VECURONI UM BROMI DE, VECURONI UM BROMI DE
VERAPAMI L HYDROCHLORI DE, VERAPAMI L HYDROCHLORI DE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
ZOVI A 1/ 35E- 28, ETHI NYL ESTRADI OL
ZOVI A 1/ 50E- 28, ETHI NYL ESTRADI OL
* WATSON LABS I NC
LI SI NOPRI L AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
WATSON LABS ( UTAH)
* WATSON LABORATORI ES I NC
I NFED, I RON DEXTRAN
NOR- QD, NORETHI NDRONE
OXYTROL, OXYBUTYNI N
PROGESTERONE, PROGESTERONE
WATSON LABS FLORI DA
* WATSON LABORATORI ES I NC FLORI DA
ALPRAZOLAM, ALPRAZOLAM
BENAZEPRI L HYDROCHLORI DE AND HYDROCHLOROTHI AZI DE, BENAZEPRI L HYDROCHLORI DE
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
CARTI A XT, DI LTI AZEM HYDROCHLORI DE
CI PROFLOXACI N EXTENDED RELEASE, CI PROFLOXACI N
CLARI THROMYCI N, CLARI THROMYCI N
DI LTI AZEM HYDROCHLORI DE, DI LTI AZEM HYDROCHLORI DE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
FOSI NOPRI L SODI UM AND HYDROCHLOROTHI AZI DE, FOSI NOPRI L SODI UM
FOSI NOPRI L SODI UM, FOSI NOPRI L SODI UM
GLI MEPI RI DE, GLI MEPI RI DE
HYDROCODONE BI TARTRATE AND ACETAMI NOPHEN, ACETAMI NOPHEN
HYDROCODONE BI TARTRATE AND I BUPROFEN, HYDROCODONE BI TARTRATE
KETOPROFEN, KETOPROFEN
LEVETI RACETAM, LEVETI RACETAM
LORATADI NE AND PSEUDOEPHEDRI NE SULFATE, LORATADI NE ( OTC)
LORATADI NE, LORATADI NE ( OTC)
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
METOPROLOL SUCCI NATE, METOPROLOL SUCCI NATE
MI RTAZAPI NE, MI RTAZAPI NE
OMEPRAZOLE, OMEPRAZOLE
POTASSI UM CHLORI DE, POTASSI UM CHLORI DE
QUI NAPRI L HYDROCHLORI DE, QUI NAPRI L HYDROCHLORI DE
RI SPERI DONE, RI SPERI DONE
TAMOXI FEN CI TRATE, TAMOXI FEN CI TRATE
TAZTI A XT, DI LTI AZEM HYDROCHLORI DE
WATSON LABS I NC
* WATSON LABORATORI ES I NC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMLODI PI NE BESYLATE AND BENAZEPRI L HYDROCHLORI DE, AMLODI PI NE BESYLATE

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 148
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * W * *
* WATSON LABORATORI ES I NC
AMMONI UM LACTATE, AMMONI UM LACTATE
ARMODAFI NI L, ARMODAFI NI L
BUDESONI DE, BUDESONI DE
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
CI CLOPI ROX, CI CLOPI ROX
CYCLOSPORI NE, CYCLOSPORI NE
DEXMETHYLPHENI DATE HYDROCHLORI DE, DEXMETHYLPHENI DATE HYDROCHLORI DE
DI CLOFENAC SODI UM AND MI SOPROSTOL, DI CLOFENAC SODI UM
FI ORI CET W/ CODEI NE, ACETAMI NOPHEN
FI ORI NAL W/ CODEI NE, ASPI RI N
FI ORI NAL, ASPI RI N
GELNI QUE 3%, OXYBUTYNI N
I BANDRONATE SODI UM, I BANDRONATE SODI UM
I NDOMETHACI N, I NDOMETHACI N
I RBESARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
I RBESARTAN, I RBESARTAN
KADI AN, MORPHI NE SULFATE
LAMOTRI GI NE, LAMOTRI GI NE
LEVALBUTEROL HYDROCHLORI DE, LEVALBUTEROL HYDROCHLORI DE
LEVETI RACETAM, LEVETI RACETAM
LEVOFLOXACI N, LEVOFLOXACI N
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL ( OTC)
LI DOCAI NE, LI DOCAI NE
METHYLPHENI DATE HYDROCHLORI DE, METHYLPHENI DATE HYDROCHLORI DE
PREGABALI N, PREGABALI N
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
RASAGI LI NE MESYLATE, RASAGI LI NE MESYLATE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
SI LDENAFI L CI TRATE, SI LDENAFI L CI TRATE
URSODI OL, URSODI OL
VALSARTAN AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
WATSON LABS I NC FL
* WATSON LABORATORI ES I NC FLORI DA
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
FLUTAMI DE, FLUTAMI DE
TRANEXAMI C ACI D, TRANEXAMI C ACI D
TROSPI UM CHLORI DE, TROSPI UM CHLORI DE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
WATSON PHARMS
* WATSON PHARMACEUTI CALS
TENUATE DOSPAN, DI ETHYLPROPI ON HYDROCHLORI DE
TENUATE, DI ETHYLPROPI ON HYDROCHLORI DE
* WATSON PHARMACEUTI CALS I NC
ACTI GALL, URSODI OL
CONDYLOX, PODOFI LOX
CORDRAN, FLURANDRENOLI DE
FI ORI CET, ACETAMI NOPHEN
WEI LL MEDCL COLL
* WEI LL MEDI CAL COLLEGE CORNELL UNI V
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F- 18
WELLSPRI NG PHARM
* WELLSPRI NG PHARMACEUTI CAL CORP
DI BENZYLI NE, PHENOXYBENZAMI NE HYDROCHLORI DE
DUVOI D, BETHANECHOL CHLORI DE
DYRENI UM, TRI AMTERENE
WEST WARD
* WEST WARD I NC
ERGOTAMI NE TARTRATE AND CAFFEI NE, CAFFEI NE
I SOSORBI DE DI NI TRATE, I SOSORBI DE DI NI TRATE
* WEST WARD PHARMACEUTI CAL CORP
BUTALBI TAL, ACETAMI NOPHEN AND CAFFEI NE, ACETAMI NOPHEN
BUTALBI TAL, ACETAMI NOPHEN, CAFFEI NE AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
BUTALBI TAL, ASPI RI N AND CAFFEI NE, ASPI RI N


34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 149
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * W * *
* WEST WARD PHARMACEUTI CAL CORP
CAPTOPRI L, CAPTOPRI L
CHLOROQUI NE PHOSPHATE, CHLOROQUI NE PHOSPHATE
CORTI SONE ACETATE, CORTI SONE ACETATE
DOXYCYCLI NE HYCLATE, DOXYCYCLI NE HYCLATE
FOLI C ACI D, FOLI C ACI D
HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
HYDROXYCHLOROQUI NE SULFATE, HYDROXYCHLOROQUI NE SULFATE
I SOSORBI DE DI NI TRATE, I SOSORBI DE DI NI TRATE
I SOSORBI DE MONONI TRATE, I SOSORBI DE MONONI TRATE
LI THI UM CARBONATE, LI THI UM CARBONATE
METHOCARBAMOL, METHOCARBAMOL
PRI MI DONE, PRI MI DONE
ZALEPLON, ZALEPLON
WEST WARD PHARM CORP
* WEST WARD PHARMACEUTI CAL CORP
NAPROXEN, NAPROXEN
PHENYLEPHRI NE HYDROCHLORI DE, PHENYLEPHRI NE HYDROCHLORI DE
WEST WARD PHARMS
* WEST WARD PHARMACEUTI CALS CORP
RI SPERI DONE, RI SPERI DONE
WEST- WARD PHARM CORP
* WEST- WARD PHARMACEUTI CAL CORP
CEFOTETAN, CEFOTETAN DI SODI UM
FLUDROCORTI SONE ACETATE, FLUDROCORTI SONE ACETATE
WI MEDCL CYCLOTRON
* WI SCONSI N MEDI CAL CYCLOTRON LLC
FLUDEOXYGLUCOSE F- 18, FLUDEOXYGLUCOSE F- 18
WI LSHI RE PHARMS I NC
* WI LSHI RE PHARMACEUTI CALS I NC
LAMOTRI GI NE, LAMOTRI GI NE
WOCKHARDT
* WOCKHARDT AMERI CAS I NC
CAPTOPRI L, CAPTOPRI L
FAMOTI DI NE, FAMOTI DI NE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
* WOCKHARDT EU OPERATI ONS ( SWI SS) AG
ACETAMI NOPHEN AND CODEI NE PHOSPHATE, ACETAMI NOPHEN
ACETI C ACI D, ACETI C ACI D, GLACI AL
AMANTADI NE HYDROCHLORI DE, AMANTADI NE HYDROCHLORI DE
AMOXI CI LLI N AND CLAVULANATE POTASSI UM, AMOXI CI LLI N
AMOXI CI LLI N, AMOXI CI LLI N
BROMFED- DM, BROMPHENI RAMI NE MALEATE
CARBAMAZEPI NE, CARBAMAZEPI NE
CHLORHEXI DI NE GLUCONATE, CHLORHEXI DI NE GLUCONATE
CI METI DI NE HYDROCHLORI DE, CI METI DI NE HYDROCHLORI DE
CLEMASTI NE FUMARATE, CLEMASTI NE FUMARATE
CLI NDAMYCI N PHOSPHATE, CLI NDAMYCI N PHOSPHATE
CLOBETASOL PROPI ONATE, CLOBETASOL PROPI ONATE
CROMOLYN SODI UM, CROMOLYN SODI UM
CYCLOSPORI NE, CYCLOSPORI NE
DEXCHLORPHENI RAMI NE MALEATE, DEXCHLORPHENI RAMI NE MALEATE
DOXEPI N HYDROCHLORI DE, DOXEPI N HYDROCHLORI DE
ERYTHROMYCI N, ERYTHROMYCI N
FLUOXETI NE HYDROCHLORI DE, FLUOXETI NE HYDROCHLORI DE
FLUTI CASONE PROPI ONATE, FLUTI CASONE PROPI ONATE
FUROSEMI DE, FUROSEMI DE
HYDROCODONE BI TARTRATE AND HOMATROPI NE METHYLBROMI DE, HOMATROPI NE METHYLBROMI DE
HYDROXYZI NE HYDROCHLORI DE, HYDROXYZI NE HYDROCHLORI DE
LEVETI RACETAM, LEVETI RACETAM
LI DOCAI NE HYDROCHLORI DE, LI DOCAI NE HYDROCHLORI DE
LI NDANE, LI NDANE
LI THI UM CI TRATE, LI THI UM CI TRATE
LOPERAMI DE HYDROCHLORI DE, LOPERAMI DE HYDROCHLORI DE ( OTC)
LORATADI NE, LORATADI NE ( OTC)





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
B - 150
* * W * *
*
*
WOCKHARDT EU OPERATI ONS ( SWI SS) AG
MEGESTROL ACETATE, MEGESTROL ACETATE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METOCLOPRAMI DE HYDROCHLORI DE, METOCLOPRAMI DE HYDROCHLORI DE
MI NOXI DI L ( FOR MEN) , MI NOXI DI L ( OTC)
MI NOXI DI L EXTRA STRENGTH ( FOR MEN) , MI NOXI DI L ( OTC)
NYSTATI N, NYSTATI N
OXYBUTYNI N CHLORI DE, OXYBUTYNI N CHLORI DE
PHENYTOI N, PHENYTOI N
PREDNI SOLONE SODI UM PHOSPHATE, PREDNI SOLONE SODI UM PHOSPHATE
PREDNI SOLONE, PREDNI SOLONE
PROMETHAZI NE HYDROCHLORI DE AND CODEI NE PHOSPHATE, CODEI NE PHOSPHATE
PROMETHAZI NE PLAI N, PROMETHAZI NE HYDROCHLORI DE
PROMETHAZI NE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMI DE
SELENI UM SULFI DE, SELENI UM SULFI DE
TRETI NOI N, TRETI NOI N
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
VALPROI C ACI D, VALPROI C ACI D
WOCKHARDT LTD
ADENOSI NE, ADENOSI NE
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
AZI THROMYCI N, AZI THROMYCI N
BETAXOLOL HYDROCHLORI DE, BETAXOLOL HYDROCHLORI DE
BETHANECHOL CHLORI DE, BETHANECHOL CHLORI DE
CEFOTAXI ME SODI UM, CEFOTAXI ME SODI UM
CEFOTAXI ME, CEFOTAXI ME SODI UM
CEFPROZI L, CEFPROZI L
CEFTAZI DI ME, CEFTAZI DI ME
CEFTRI AXONE, CEFTRI AXONE SODI UM
CEFUROXI ME AXETI L, CEFUROXI ME AXETI L
CETI RI ZI NE HYDROCHLORI DE ALLERGY, CETI RI ZI NE HYDROCHLORI DE ( OTC)
CETI RI ZI NE HYDROCHLORI DE, CETI RI ZI NE HYDROCHLORI DE
CLARI THROMYCI N, CLARI THROMYCI N
DI VALPROEX SODI UM, DI VALPROEX SODI UM
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
EXTENDED PHENYTOI N SODI UM, PHENYTOI N SODI UM
FAMOTI DI NE, FAMOTI DI NE ( OTC)
FOSPHENYTOI N SODI UM, FOSPHENYTOI N SODI UM
FUROSEMI DE, FUROSEMI DE
KETOROLAC TROMETHAMI NE, KETOROLAC TROMETHAMI NE
LEVETI RACETAM, LEVETI RACETAM
LEVOFLOXACI N, LEVOFLOXACI N
LI SI NOPRI L, LI SI NOPRI L
METOPROLOL SUCCI NATE, METOPROLOL SUCCI NATE
MI DAZOLAM HYDROCHLORI DE, MI DAZOLAM HYDROCHLORI DE
NI ACI N, NI ACI N
NI CARDI PI NE HYDROCHLORI DE, NI CARDI PI NE HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE PRESERVATI VE FREE, ONDANSETRON HYDROCHLORI DE
ONDANSETRON HYDROCHLORI DE, ONDANSETRON HYDROCHLORI DE
PANTOPRAZOLE SODI UM, PANTOPRAZOLE SODI UM
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE ( OTC)
RI SPERI DONE, RI SPERI DONE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SUMATRI PTAN SUCCI NATE, SUMATRI PTAN SUCCI NATE
TAMSULOSI N HYDROCHLORI DE, TAMSULOSI N HYDROCHLORI DE
TERBI NAFI NE HYDROCHLORI DE, TERBI NAFI NE HYDROCHLORI DE
TI MOLOL MALEATE, TI MOLOL MALEATE
VALACYCLOVI R HYDROCHLORI DE, VALACYCLOVI R HYDROCHLORI DE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
ZOLPI DEM TARTRATE, ZOLPI DEM TARTRATE
ZONI SAMI DE, ZONI SAMI DE





34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 151
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * W * *
WOCKHARDT EU OPERATN
* WOCKHARDT EU OPERATI ONS SWI SS AG
AMOXI CI LLI N AND CLAVULANATE POTASSI UM, AMOXI CI LLI N
DEXAMETHASONE, DEXAMETHASONE
TRI AMCI NOLONE ACETONI DE, TRI AMCI NOLONE ACETONI DE
WOCKHARDT LTD
* WOCKHARDT LTD
ALFUZOSI N HYDROCHLORI DE, ALFUZOSI N HYDROCHLORI DE
BUPROPI ON HYDROCHLORI DE, BUPROPI ON HYDROCHLORI DE
CARBI DOPA, LEVODOPA AND ENTACAPONE, CARBI DOPA
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CHI LDREN' S FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
ENTACAPONE, ENTACAPONE
FELODI PI NE, FELODI PI NE
FEXOFENADI NE HYDROCHLORI DE ALLERGY, FEXOFENADI NE HYDROCHLORI DE ( OTC)
FEXOFENADI NE HYDROCHLORI DE HI VES, FEXOFENADI NE HYDROCHLORI DE ( OTC)
LAMOTRI GI NE, LAMOTRI GI NE
LANSOPRAZOLE, LANSOPRAZOLE ( OTC)
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
ZI PRASI DONE HYDROCHLORI DE, ZI PRASI DONE HYDROCHLORI DE
WOCKHARDT USA
* WOCKHARDT USA I NC
EXTENDED PHENYTOI N SODI UM, PHENYTOI N SODI UM
GRANI SETRON HYDROCHLORI DE, GRANI SETRON HYDROCHLORI DE
OCTREOTI DE ACETATE ( PRESERVATI VE FREE) , OCTREOTI DE ACETATE
OCTREOTI DE ACETATE, OCTREOTI DE ACETATE
* WOCKHARDT USA LLC
ENALAPRI L MALEATE, ENALAPRI L MALEATE
LANSOPRAZOLE, LANSOPRAZOLE
TOPI RAMATE, TOPI RAMATE
WORLD GEN
* WORLD GEN LLC
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
WRASER PHARMS
* WRASER PHARMACEUTI CALS LLC
CETRAXAL, CI PROFLOXACI N HYDROCHLORI DE
WYETH PHARMS
* WYETH PHARMACEUTI CALS I NC SUB PFI ZER I NC
LO/ OVRAL- 28, ETHI NYL ESTRADI OL
WYETH PHARMS I NC
* WYETH PHARMACEUTI CALS I NC
BOSULI F, BOSUTI NI B MONOHYDRATE
CORDARONE, AMI ODARONE HYDROCHLORI DE
EFFEXOR XR, VENLAFAXI NE HYDROCHLORI DE
I NDERAL, PROPRANOLOL HYDROCHLORI DE
I NDERI DE- 40/ 25, HYDROCHLOROTHI AZI DE
PHOSPHOLI NE I ODI DE, ECHOTHI OPHATE I ODI DE
PREMARI N, ESTROGENS, CONJ UGATED
PREMPHASE 14/ 14, ESTROGENS, CONJ UGATED
PREMPRO, ESTROGENS, CONJ UGATED
PRI STI Q, DESVENLAFAXI NE SUCCI NATE
PROTONI X I V, PANTOPRAZOLE SODI UM
PROTONI X, PANTOPRAZOLE SODI UM
TRECATOR, ETHI ONAMI DE
ZOSYN I N PLASTI C CONTAI NER, PI PERACI LLI N SODI UM
ZOSYN, PI PERACI LLI N SODI UM
WYETH PHARMS PFI ZER
* WYETH PHARMACEUTI CALS I NC WHOLLY OWNED SUB PFI ZER I NC
DUAVEE, BAZEDOXI FENE ACETATE
* * X * *
X GEN PHARMS
* X GEN PHARMACEUTI CALS I NC
ACETAZOLAMI DE SODI UM, ACETAZOLAMI DE SODI UM

34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 152
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * X * *
* X GEN PHARMACEUTI CALS I NC
AMPHOTERI CI N B, AMPHOTERI CI N B
BACI I M, BACI TRACI N
COLI STI METHATE SODI UM, COLI STI METHATE SODI UM
HYDRO- RX, HYDROCORTI SONE
HYDROCORTI SONE ACETATE, HYDROCORTI SONE ACETATE
LEVETI RACETAM, LEVETI RACETAM
LI OTHYRONI NE SODI UM, LI OTHYRONI NE SODI UM
NEO- FRADI N, NEOMYCI N SULFATE
NEOMYCI N AND POLYMYXI N B SULFATE, NEOMYCI N SULFATE
NEOMYCI N SULFATE, NEOMYCI N SULFATE
NYSTATI N, NYSTATI N
POLYMYXI N B SULFATE, POLYMYXI N B SULFATE
STREPTOMYCI N SULFATE, STREPTOMYCI N SULFATE
TOBRAMYCI N SULFATE, TOBRAMYCI N SULFATE
X- GEN PHARMS
* X- GEN PHARMACEUTI CALS I NC
PHENYTOI N SODI UM, PHENYTOI N SODI UM
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
X- GEN PHARMS I NC
* X- GEN PHARMACEUTI CALS I NC
TRANEXAMI C ACI D, TRANEXAMI C ACI D
XELLI A PHARMS APS
* XELLI A PHARMACEUTI CALS APS
POLYMYXI N B SULFATE, POLYMYXI N B SULFATE
XENOPORT I NC
* XENOPORT I NC
HORI ZANT, GABAPENTI N ENACARBI L
XOMA
* XOMA ( US) LLC
ACEON, PERI NDOPRI L ERBUMI NE
XSPI RE
* XSPI RE LLC
NALFON, FENOPROFEN CALCI UM
XTTRI UM
* XTTRI UM LABORATORI ES I NC
CHLORHEXI DI NE GLUCONATE, CHLORHEXI DI NE GLUCONATE
EXI DI NE, CHLORHEXI DI NE GLUCONATE ( OTC)
* * Y * *
YUNG SHI N PHARM
* YUNG SHI N PHARMACEUTI CAL I NDUSTRI AL CO LTD
CEFACLOR, CEFACLOR
CEPHALEXI N, CEPHALEXI N
* * Z * *
ZACH SYSTEMS
* ZACH SYSTEMS SPA
DORZOLAMI DE HYDROCHLORI DE AND TI MOLOL MALEATE, DORZOLAMI DE HYDROCHLORI DE
DORZOLAMI DE HYDROCHLORI DE, DORZOLAMI DE HYDROCHLORI DE
ZAMBON SPA
* ZAMBON SPA I TALY
MONUROL, FOSFOMYCI N TROMETHAMI NE
ZOGENI X I NC
* ZOGENI X I NC
SUMAVEL DOSEPRO, SUMATRI PTAN SUCCI NATE
ZOHYDRO ER, HYDROCODONE BI TARTRATE
ZYDUS HLTHCARE
* ZYDUS HEALTHCARE USA LLC
LANSOPRAZOLE, LANSOPRAZOLE
ZYDUS PHARMS USA
* ZYDUS PHARMACEUTI CALS USA I NC
AMLODI PI NE BESYLATE, AMLODI PI NE BESYLATE
ATENOLOL, ATENOLOL
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
B - 153
APPENDI X B - PRODUCT NAME SORTED BY APPLI CANT
* * Z * *
* ZYDUS PHARMACEUTI CALS USA I NC
AZATHI OPRI NE, AZATHI OPRI NE
BENAZEPRI L HYDROCHLORI DE, BENAZEPRI L HYDROCHLORI DE
BENZONATATE, BENZONATATE
CLI NDAMYCI N HYDROCHLORI DE, CLI NDAMYCI N HYDROCHLORI DE
HALOPERI DOL, HALOPERI DOL
LAMOTRI GI NE, LAMOTRI GI NE
MELOXI CAM, MELOXI CAM
METFORMI N HYDROCHLORI DE, METFORMI N HYDROCHLORI DE
NAPROXEN, NAPROXEN
PAROXETI NE HYDROCHLORI DE, PAROXETI NE HYDROCHLORI DE
PRAVASTATI N SODI UM, PRAVASTATI N SODI UM
PROMETHAZI NE HYDROCHLORI DE, PROMETHAZI NE HYDROCHLORI DE
RAMI PRI L, RAMI PRI L
RI BAVI RI N, RI BAVI RI N
RI SPERI DONE, RI SPERI DONE
SERTRALI NE HYDROCHLORI DE, SERTRALI NE HYDROCHLORI DE
SI MVASTATI N, SI MVASTATI N
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
WARFARI N SODI UM, WARFARI N SODI UM
ZONI SAMI DE, ZONI SAMI DE
ZYDUS PHARMS USA I NC
* ZYDUS PHARMACEUTI CALS USA I NC
ACETAZOLAMI DE, ACETAZOLAMI DE
ALPRAZOLAM, ALPRAZOLAM
AMI ODARONE HYDROCHLORI DE, AMI ODARONE HYDROCHLORI DE
ANASTROZOLE, ANASTROZOLE
BI CALUTAMI DE, BI CALUTAMI DE
BROMOCRI PTI NE MESYLATE, BROMOCRI PTI NE MESYLATE
CARVEDI LOL, CARVEDI LOL
CLOPI DOGREL BI SULFATE, CLOPI DOGREL BI SULFATE
DI PYRI DAMOLE, DI PYRI DAMOLE
DI VALPROEX SODI UM, DI VALPROEX SODI UM
DONEPEZI L HYDROCHLORI DE, DONEPEZI L HYDROCHLORI DE
DULOXETI NE HYDROCHLORI DE, DULOXETI NE HYDROCHLORI DE
ESCI TALOPRAM OXALATE, ESCI TALOPRAM OXALATE
ETHOSUXI MI DE, ETHOSUXI MI DE
FI NASTERI DE, FI NASTERI DE
GABAPENTI N, GABAPENTI N
GALANTAMI NE HYDROBROMI DE, GALANTAMI NE HYDROBROMI DE
GLI PI ZI DE AND METFORMI N HYDROCHLORI DE, GLI PI ZI DE
HYDROXYCHLOROQUI NE SULFATE, HYDROXYCHLOROQUI NE SULFATE
I NDOMETHACI N, I NDOMETHACI N
I RBESARTAN, I RBESARTAN
LAMOTRI GI NE, LAMOTRI GI NE
LEVETI RACETAM, LEVETI RACETAM
LEVOFLOXACI N, LEVOFLOXACI N
LOSARTAN POTASSI UM AND HYDROCHLOROTHI AZI DE, HYDROCHLOROTHI AZI DE
LOSARTAN POTASSI UM, LOSARTAN POTASSI UM
OMEPRAZOLE, OMEPRAZOLE
PI OGLI TAZONE HYDROCHLORI DE, PI OGLI TAZONE HYDROCHLORI DE
PRAMI PEXOLE DI HYDROCHLORI DE, PRAMI PEXOLE DI HYDROCHLORI DE
PROPRANOLOL HYDROCHLORI DE, PROPRANOLOL HYDROCHLORI DE
RAMI PRI L, RAMI PRI L
RANI TI DI NE HYDROCHLORI DE, RANI TI DI NE HYDROCHLORI DE
RI SPERI DONE, RI SPERI DONE
ROPI NI ROLE HYDROCHLORI DE, ROPI NI ROLE HYDROCHLORI DE
SI ROLI MUS, SI ROLI MUS
TAMSULOSI N HYDROCHLORI DE, TAMSULOSI N HYDROCHLORI DE
TOPI RAMATE, TOPI RAMATE
TRAMADOL HYDROCHLORI DE AND ACETAMI NOPHEN, ACETAMI NOPHEN
TRAMADOL HYDROCHLORI DE, TRAMADOL HYDROCHLORI DE
VENLAFAXI NE HYDROCHLORI DE, VENLAFAXI NE HYDROCHLORI DE
ZOLMI TRI PTAN, ZOLMI TRI PTAN






















































































C- 1 34TH EDI TI ON - 2014 - APPROVED DRUG PRODUCTS LI ST
APPENDIX C
UNIFORM TERMS
DOSAGE FORMS
AEROSOL
AEROSOL, FOAM
AEROSOL, METERED
CAPSULE
CAPSULE, DELAYED REL PELLETS
CAPSULE, DELAYED RELEASE
CAPSULE, EXTENDED RELEASE
CLOTH
CONCENTRATE
CREAM
CREAM, AUGMENTED
ELIXIR
EMULSION
ENEMA
FILM
FILM, EXTENDED RELEASE
FOR SOLUTION
FOR SUSPENSION
FOR SUSPENSION, DELAYED RELEASE
FOR SUSPENSION, EXTENDED RELEASE
GAS
GEL
GEL, AUGMENTED
GEL, METERED
GRANULE
GRANULE, DELAYED RELEASE
GUM, CHEWING
IMPLANT
INHALANT
INJ ECTABLE
INJ ECTABLE, LIPID COMPLEX
INJ ECTABLE, LIPOSOMAL
INSERT
INSERT, EXTENDED RELEASE
INTRAUTERINE DEVICE
J ELLY
LIQUID
LOTION
LOTION, AUGMENTED
LOTION/SHAMPOO
Note: Terms comprise currently marketed products
OIL
OIL/DROPS
OINTMENT
OINTMENT, AUGMENTED
PASTE
PATCH
PELLET
POWDER
POWDER, EXTENDED RELEASE
POWDER, METERED
RING
SHAMPOO
SOLUTION
SOLUTION FOR SLUSH
SOLUTION, GEL FORMING/DROPS
SOLUTION, METERED
SOLUTION/DROPS
SPONGE
SPRAY
SPRAY, METERED
SUPPOSITORY
SUSPENSION
SUSPENSION, EXTENDED RELEASE
SUSPENSION/DROPS
SWAB
SYRUP
SYSTEM
SYSTEM, EXTENDED RELEASE
TABLET
TABLET, CHEWABLE
TABLET, COATED PARTICLES
TABLET, DELAYED RELEASE
TABLET, DELAYED RELEASE, ORALLY
DISINTEGRATING
TABLET, EFFERVESCENT
TABLET, EXTENDED RELEASE
TABLET, FOR SUSPENSION
TABLET, ORALLY DISINTEGRATING
TAPE
TROCHE/LOZENGE















































C- 2 34TH EDI TI ON - 2014 - APPROVED DRUG PRODUCTS LI ST
APPENDIX C
UNIFORM TERMS
ROUTES OF ADMINISTRATION
BUCCAL
DENTAL
ENDOCERVICAL
FOR RX COMPOUNDING
IMPLANTATION
INHALATION
INJ ECTION
INTRA-ANAL
INTRACRANIAL
INTRAMUSCULAR
INTRAOCULAR
INTRAPERITONEAL
INTRAPLEURAL
INTRATHECAL
INTRATRACHEAL
INTRAUTERINE
INTRAVENOUS
INTRAVESICAL
INTRAVITREAL
IONTOPHORESIS
Note: Terms comprise currently marketed products
IRRIGATION
IV (INFUSION)
N/A
NASAL
OPHTHALMIC
ORAL
ORAL-21
ORAL-28
OTIC
PERFUSION, CARDIAC
PERIODONTAL
RECTAL
SPINAL
SUBCUTANEOUS
SUBLINGUAL
TOPICAL
TRANSDERMAL
TRANSMUCOSAL
URETHRAL
VAGINAL
C- 3 34TH EDI TI ON - 2014 - APPROVED DRUG PRODUCTS LI ST
APPENDIX C
UNIFORM TERMS
ABBREVIATIONS
AMP AMPULE
AMPICIL AMPICILLIN
APPROX APPROXIMATELY
BOT BOTTLE
CI CURIE
CSR CAROTID SINUS REFLEX
CU CLINICAL UNITS
DIPROP DIPROPIONATE
ELECT ELECTROLYTE
EQ EQUIVALENT TO
ER EXTENDED RELEASE
GM GRAM
HBR HYDROBROMIDE
HCL HYDROCHLORIDE
HR HOUR
IM INTRAMUSCULAR
INH INHALATION
IU INTERNATIONAL UNITS
IV INTRAVENOUS
KIU KALLIKREIN INHIBITOR UNITS
MCG MICROGRAM
mCi MILLICURIE
MEQ MILLIEQUIVALENT
MG MILLIGRAM
ML MILLILITER
N/A NOT APPLICABLE
PPM PARTS PER MILLION
REL RELEASE
SQ CM SQUARE CENTIMETER
U UNITS
uCi MICROCURIE
UMOLAR MICROMOLAR
USP UNITED STATES PHARMACOPEIA












PATENT AND EXCLUSIVITY INFORMATION ADDENDUM
Thi s Addendum i dent i f i es dr ugs t hat qual i f y under t he Dr ug Pr i ce
Compet i t i on and Pat ent Ter mRest or at i on Act ( 1984 Amendment s) f or per i ods of
excl usi vi t y, dur i ng whi ch abbr evi at ed new dr ug appl i cat i ons ( ANDAs) and
appl i cat i ons descr i bed i n Sect i on 505( b) ( 2) of t he Feder al Food, Dr ug, and
Cosmet i c Act ( t he Act ) f or t hose dr ug pr oduct s may, i n some i nst ances, not be
submi t t ed or made ef f ect i ve as descr i bed bel ow, and pr ovi des pat ent
i nf or mat i on concer ni ng t he l i st ed dr ug pr oduct s. Those dr ugs t hat have
qual i f i ed f or Or phan Dr ug Excl usi vi t y pur suant t o Sect i on 527 of t he Act and
t hose dr ugs t hat have qual i f i ed f or Pedi at r i c Excl usi vi t y pur suant t o Sect i on
505A ar e al so i ncl uded i n t hi s Addendum. Thi s sect i on i s ar r anged i n
al phabet i cal or der by act i ve i ngr edi ent name f ol l owed t he t r ade name. Act i ve
i ngr edi ent headi ngs f or mul t i pl e i ngr edi ent ( combi nat i on) dr ug pr oduct s ar e
ar r anged al phabet i cal l y. For an expl anat i on of t he codes used i n t he
Addendum, see t he Patent and Exclusivity Terms Sect i on. Excl usi vi t y pr event s
t he submi ssi on or ef f ect i ve appr oval of ANDAs or appl i cat i ons descr i bed i n
Sect i on 505( b) ( 2) of t he Act . I t does not pr event t he submi ssi on or appr oval
of a second 505( b) ( 1) appl i cat i on except i n t he case of Or phan Dr ug
excl usi vi t y. Appl i cat i ons qual i f yi ng f or per i ods of excl usi vi t y ar e:
( 1) A new dr ug appl i cat i on appr oved af t er Sept ember 24, 1984, f or a dr ug
pr oduct al l act i ve i ngr edi ent s ( i ncl udi ng any est er or sal t of t he
act i ve i ngr edi ent ) of whi ch had never been appr oved i n any ot her new
dr ug appl i cat i on under Sect i on 505 ( b) of t he Act . No subsequent ANDA
or appl i cat i on descr i bed i n Sect i on 505( b) ( 2) of t he Act f or t he same
dr ug may be submitted f or a per i od of five years f r omt he dat e of
appr oval of t he or i gi nal appl i cat i on, except t hat such an appl i cat i on
may be submitted af t er four years i f i t cont ai ns a cer t i f i cat i on t hat a
pat ent cl ai mi ng t he dr ug i s i nval i d or wi l l not be i nf r i nged by t he
pr oduct f or whi ch appr oval i s sought .
( 2) A new dr ug appl i cat i on appr oved af t er Sept ember 24, 1984, f or a dr ug
pr oduct cont ai ni ng an act i ve i ngr edi ent ( i ncl udi ng any est er or sal t of
t hat act i ve i ngr edi ent ) t hat has been appr oved i n an ear l i er new dr ug
appl i cat i on and t hat i ncl udes r epor t s of new cl i ni cal i nvest i gat i ons
( ot her t han bi oavai l abi l i t y st udi es) . Such i nvest i gat i ons must have
been conduct ed or sponsor ed by t he appl i cant and must have been
essent i al t o appr oval of t he appl i cat i on. I f t hese r equi r ement s ar e
met , t he appr oval of a subsequent ANDA or an appl i cat i on descr i bed i n
Sect i on 505( b) ( 2) of t he Act may not be made effective f or t he same dr ug
or use, i f f or a new i ndi cat i on, bef or e t he expi r at i on of three years
f r omt he dat e of appr oval of t he or i gi nal appl i cat i on. I f an appl i cant
has excl usi vi t y f or a new appl i cat i on or 505( b) ( 2) appl i cat i on f or t he
dr ug pr oduct wi t h i ndi cat i ons or use, t hi s does not pr ecl ude t he
appr oval of an ANDA or 505( b) ( 2) appl i cat i on not cover ed by t he
excl usi vi t y.
( 3) A suppl ement t o a new dr ug appl i cat i on f or a dr ug cont ai ni ng a
pr evi ousl y appr oved act i ve i ngr edi ent i ncl udi ng ( any est er or sal t of
t he act i ve i ngr edi ent ) appr oved af t er Sept ember 24, 1984, t hat cont ai ns
r epor t s of new cl i ni cal i nvest i gat i ons ( ot her t han bi oavai l abi l i t y
st udi es) essent i al t o t he appr oval of t he suppl ement and conduct ed or
sponsor ed by t he appl i cant . The appr oval of a subsequent ANDA or
505( b) ( 2) appl i cat i on f or a change appr oved i n t he suppl ement may not be
AD 1













made effective f or three years f r omt he dat e of appr oval of t he or i gi nal
suppl ement .
The Act r equi r es t hat pat ent i nf or mat i on be f i l ed wi t h al l newl y
submi t t ed Sect i on 505( b) dr ug appl i cat i ons. No NDA may be appr oved af t er
Sept ember 24, 1984, wi t hout t he submi ssi on of pat ent i nf or mat i on t o t he
Agency. Ef f ect i ve August 18, 2003, t hi s i nf or mat i on must be f i l ed usi ng FDA
For m3524a Pat ent I nf or mat i on Submi t t ed wi t h t he Fi l i ng of an NDA, Amendment
or Suppl ement .
Ef f ect i ve August 18, 2003, upon appr oval of an appl i cat i on, pat ent
i nf or mat i on f or pur poses of l i st i ng i n t he Or ange Book must be submi t t ed t o
t he agency wi t hi n 30 days of appr oval on FDA For m3542 Pat ent I nf or mat i on
Submi t t ed Upon and Af t er Appr oval of an NDA or Suppl ement . Pat ent
i nf or mat i on on unappr oved appl i cat i ons or on pat ent s beyond t he scope of t he
Act ( i . e. , pr ocess or manuf act ur i ng pat ent s) wi l l not be publ i shed. FDA f or m
3542 wi l l be t he onl y f or mused f or t he pur poses of t hi s publ i cat i on.
The pat ent s t hat FDA r egar ds as cover ed by t he st at ut or y pr ovi si ons f or
submi ssi on of pat ent i nf or mat i on ar e: pat ent s t hat cl ai mt he act i ve
i ngr edi ent ( s) ; dr ug pr oduct pat ent s whi ch i ncl ude f or mul at i on/ composi t i on
pat ent s; use pat ent s f or a par t i cul ar appr oved i ndi cat i on or met hod of usi ng
t he pr oduct ; and cer t ai n ot her pat ent s as det ai l ed on FDA For m3542. Thi s
i nf or mat i on, as pr ovi ded by t he sponsor on FDA f or m3542, wi l l be publ i shed
as descr i bed above.
A r equi r ement f or submi ssi on of pat ent i nf or mat i on t o FDA f or cer t ai n
ol d ant i bi ot i cs became ef f ect i ve Oct ober 7, 2008 under sect i on 4( b) ( 1) of t he
Q1 Act . A gui dance f or i ndust r y on t hi s subj ect i s avai l abl e at
ht t p: / / www. f da. gov/ downl oads/ About FDA/ Repor t sManual sFor ms/ For ms/ UCM048345. pdf
Upon appr oval , pat ent number s and expi r at i on dat es, i n addi t i on t o
cer t ai n ot her i nf or mat i on on appr opr i at e pat ent s cl ai mi ng dr ug pr oduct s t hat
ar e t he subj ect of appr oved appl i cat i ons, wi l l be publ i shed dai l y i n t he
El ect r oni c Or ange Book Quer y. The Addenduml i st s pat ent and excl usi vi t y
i nf or mat i on up t o J anuar y of t he Edi t i on year . The mont hl y Cumul at i ve
Suppl ement s t o t he annual edi t i on l i st pat ent and excl usi vi t y i nf or mat i on
changes si nce t he Annual Edi t i on Addendum. Si nce al l par t s of t hi s
publ i cat i on ar e subj ect t o changes, addi t i ons, or del et i ons, t he El ect r oni c
Or ange Book, updat ed dai l y, shoul d be consul t ed f or t he most r ecent pat ent
and excl usi vi t y i nf or mat i on.
AD 2
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 1 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ABACAVIR SULFATE - ZIAGEN
N 020977 001 6294540 May 14, 2018 DS DP U-65
ABACAVIR SULFATE - ZIAGEN
N 020978 001 6294540 May 14, 2018 DS DP U-65
6641843 Feb 04, 2019 DP
ABACAVIR SULFATE; LAMIVUDINE - EPZICOM
N 021652 001 5905082 May 18, 2016 DS DP
6294540 May 14, 2018 DS DP U-257
6417191 Mar 28, 2016 DP U-257
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE - ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
A 202912 001 PC Jun 15, 2014
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE - TRIZIVIR
N 021205 001 5905082 May 18, 2016 DS DP U-248
6294540 May 14, 2018 DS DP U-65
6417191 Mar 28, 2016 DP U-248
ABARELIX - PLENAXIS
N 021320 001 5843901 Dec 01, 2015 DS DP
5968895 Dec 11, 2016 DP
6180608 Dec 11, 2016 DP U-549
6423686 Jun 07, 2015 DS
6455499 Jun 07, 2015 U-549
6699833 Dec 11, 2016 DP
ABIRATERONE ACETATE - ZYTIGA
N 202379 001 5604213 Dec 13, 2016 DS DP U-1126 I-663 Dec 10, 2015
5604213 Dec 13, 2016 DS DP U-1314 NCE Apr 28, 2016
ACETAMINOPHEN - OFIRMEV
N 022450 001 6028222 Aug 05, 2017 DP NP Nov 02, 2013
6992218 Jun 06, 2021 DP
ACETAMINOPHEN; ASPIRIN; CAFFEINE - EXCEDRIN (MIGRAINE)
N 020802 001 5972916 Jul 14, 2017 U-296
ACETYLCYSTEINE - ACETADOTE
N 021539 001 8148356 May 21, 2026 DP
8399445 Aug 24, 2025 U-1373
ACLIDINIUM BROMIDE - TUDORZA PRESSAIR
N 202450 001 5840279 Jun 21, 2016 DP NCE Jul 23, 2017
6071498 Jun 21, 2016 DP
6681768 Aug 07, 2022 DP
6750226 Sep 05, 2020 DS DP U-1264
7078412 Jul 16, 2020 DS DP U-1263
8051851 Apr 22, 2027 DP
ACYCLOVIR - SITAVIG
N 203791 001 8592434 Dec 09, 2029 DP U-1460 NP Apr 12, 2016
ACYCLOVIR; HYDROCORTISONE - XERESE
N 022436 001 6514980 Jan 24, 2017 DP U-1006
7223387 Feb 28, 2021 DP U-1006
RE39264 Feb 02, 2016 DP U-1006
ADAPALENE - DIFFERIN
N 021753 001 7579377 Feb 23, 2025 U-818
7737181 Aug 29, 2024 DP
7834060 Mar 12, 2023 U-1078
7838558 Mar 12, 2023 DP
7868044 Mar 12, 2023 U-1078
ADAPALENE - DIFFERIN
N 022502 001 7998467 May 31, 2028 DP U-1078
8435502 Sep 15, 2026 DP U-1078
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 2 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ADAPALENE; BENZOYL PEROXIDE - EPIDUO
N 022320 001 7820186 Nov 23, 2025
7964202 Sep 01, 2024
8071644 Jul 18, 2027
8080537 Jul 18, 2027
8105618 Dec 23, 2022
8129362 Jul 18, 2027
8241649 Dec 23, 2022
8445543 Jul 12, 2027
DP
DP U-1078
DP U-1078
U-1078
U-1078
U-1078
DP
U-1078
NPP Feb 01, 2016
ADEFOVIR DIPIVOXIL - ADEFOVIR DIPIVOXIL
A 202051 001 PC Mar 02, 2014
ADEFOVIR DIPIVOXIL - HEPSERA
N 021449 001 5663159
6451340
Sep 02, 2014
Jul 23, 2018
DS DP
DS DP U-470
ADENOSINE - ADENOSCAN
N 020059 001 5731296 Mar 24, 2015 U-221
AFATINIB DIMALEATE - GILOTRIF
N 201292 001 6251912
8426586
8545884
RE43431
Jul 29, 2018
Oct 10, 2029
Dec 19, 2029
Jan 22, 2022
DS DP U-1067
DS DP
DP
DS DP
NCE
ODE
Jul 12, 2018
Jul 12, 2020
AFATINIB DIMALEATE - GILOTRIF
N 201292 002 6251912
8426586
8545884
RE43431
Jul 29, 2018
Oct 10, 2029
Dec 19, 2029
Jan 22, 2022
DS DP U-1067
DS DP
DP
DS DP
NCE
ODE
Jul 12, 2018
Jul 12, 2020
AFATINIB DIMALEATE - GILOTRIF
N 201292 003 6251912
8426586
8545884
RE43431
Jul 29, 2018
Oct 10, 2029
Dec 19, 2029
Jan 22, 2022
DS DP U-1067
DS DP
DP
DS DP
NCE
ODE
Jul 12, 2018
Jul 12, 2020
ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE
N 020760 001 5763454
6080756
6194429
Jun 15, 2015
Jul 05, 2016
Jul 23, 2018
U-282
ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE
N 020760 002 5763454
6080756
6194429
Jun 15, 2015
Jul 05, 2016
Jul 23, 2018
U-282
ALBUMIN HUMAN - OPTISON
N 020899 001 6723303 Apr 20, 2021 DP M-120 Aug 17, 2015
ALBUTEROL SULFATE - PROVENTIL-HFA
N 020503 001 5605674
5775321
6006745
Feb 25, 2014
Jul 07, 2015
Dec 28, 2016
DP
DP
ALBUTEROL SULFATE - ACCUNEB
N 020949 001 6702997 Dec 28, 2021 U-558
ALBUTEROL SULFATE - ACCUNEB
N 020949 002 6702997 Dec 28, 2021 U-558
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 3 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALBUTEROL SULFATE - VENTOLIN HFA
N 020983 001 6161724
6170717
6315173
6431168
6435372
6510969
6558651
6596260
6743413
6938796
6966467
6997349
7107986
7143908
7350676
7500444
7832351
ALBUTEROL SULFATE - PROAIR HFA
Jan 16, 2018
Dec 23, 2017
Dec 23, 2017
Jun 08, 2018
Jan 16, 2018
Dec 23, 2017
Dec 19, 2016
Aug 10, 2014
Jun 01, 2021
Jan 16, 2018
Dec 23, 2017
Jan 16, 2018
Jun 08, 2018
Jan 16, 2018
Aug 24, 2018
Jan 04, 2025
Jun 19, 2023
DP
DP
DP
DP
DP
DP
DP U-716
DP
U-716
DP
DP
DP
DP
DP
DP
DP
DP
N 021457 001 5605674 Feb 25, 2014 DP
6446627 Dec 18, 2017 DP
7105152 Sep 12, 2023 DP
7566445 Jun 04, 2017 DP
8132712 Sep 07, 2028 DP
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - COMBIVENT
N 020291 001 5603918 Jun 09, 2015
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - DUONEB
N 020950 001 6632842 Dec 28, 2021 U-532
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - COMBIVENT RESPIMAT
N 021747 001 5472143 Sep 29, 2013 DP
5662271 Sep 02, 2014 DP
5911851 Sep 29, 2013 DP
5964416 Oct 04, 2016 DP
6007676 Sep 29, 2013 DP
6149054 Dec 19, 2016 DP
6176442 Oct 04, 2016 DP
6453795 Dec 05, 2016 DP
6503362 Sep 29, 2013 DP
6726124 Oct 04, 2016 DP
6846413 Aug 28, 2018 DP
6977042 Aug 28, 2018 DP
6988496 Feb 23, 2020 DP
7104470 Oct 04, 2016 DP
7246615 May 31, 2016 DP
7284474 Aug 26, 2024 DP
7396341 Oct 10, 2026 DP
7802568 Feb 26, 2019 DP
7837235 Mar 13, 2028 DP
7896264 May 26, 2025 DP
7988001 Aug 04, 2021 DP
ALCAFTADINE - LASTACAFT
NP Oct 07, 2014
N 022134 001 5468743 Apr 20, 2016
ALCOHOL; CHLORHEXIDINE GLUCONATE - AVAGARD
N 021074 001 5897031 Jun 21, 2016
6090395 Jun 22, 2015
6534069 Jun 22, 2015
6623744 Jun 23, 2015
7081246 Aug 03, 2016
7566460 Jun 22, 2015
ALENDRONATE SODIUM - FOSAMAX
DS DP
DP
DP
U-1008
DP
DP U-1008
NCE Jul 28, 2015
N 021575 001 5462932
5994329
6015801
6225294
May 17, 2014
Jul 17, 2018
Jul 17, 2018
Jul 17, 2018
Y
Y
Y
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 4 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALENDRONATE SODIUM - BINOSTO
N 202344 001 7488496
7964212
Aug 11, 2023
Mar 06, 2023
DS DP
DS DP
ALENDRONATE SODIUM; CHOLECALCIFEROL - FOSAMAX PLUS D
N 021762 001 5994329 Jul 17, 2018 U-647 Y
ALFUZOSIN HYDROCHLORIDE - UROXATRAL
N 021287 001 6149940 Aug 22, 2017 M-97
PED
Dec 15, 2013
Jun 15, 2014
ALISKIREN HEMIFUMARATE - TEKTURNA
N 021985 001 5559111 Jul 21, 2018 DS DP U-3
ALISKIREN HEMIFUMARATE - TEKTURNA
N 021985 002 5559111 Jul 21, 2018 DS DP U-3
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N 022545 001 5559111 Jul 21, 2018 DS DP U-3 NC Aug 26, 2013
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N 022545 002 5559111 Jul 21, 2018 DS DP U-3 NC Aug 26, 2013
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N 022545 003 5559111 Jul 21, 2018 DS DP U-3 NC Aug 26, 2013
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N 022545 004 5559111 Jul 21, 2018 DS DP U-3 NC Aug 26, 2013
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 001 5559111
8183295
Jul 21, 2018
May 16, 2023
DS DP U-3
DP
NC Dec 21, 2013
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 002 5559111
8183295
Jul 21, 2018
May 16, 2023
DS DP U-3
DP
NC Dec 21, 2013
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 003 5559111
8183295
Jul 21, 2018
May 16, 2023
DS DP U-3
DP
NC Dec 21, 2013
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 004 5559111
8183295
Jul 21, 2018
May 16, 2023
DS DP U-3
DP
NC Dec 21, 2013
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 005 5559111
8183295
Jul 21, 2018
May 16, 2023
DS DP U-3
DP
NC Dec 21, 2013
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 001 5559111 Jul 21, 2018 DS DP U-3
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 002 5559111 Jul 21, 2018 DS DP U-3
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 003 5559111 Jul 21, 2018 DS DP U-3
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 004 5559111 Jul 21, 2018 DS DP U-3
ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA
N 022217 001 5559111
8168616
Jul 21, 2018
Jul 03, 2026
DS DP U-3
DP
ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA
N 022217 002 5559111
8168616
Jul 21, 2018
Jul 03, 2026
DS DP U-3
DP
ALITRETINOIN - PANRETIN
N 020886 001 5932622 Aug 03, 2016 U-562
ALMOTRIPTAN MALATE - AXERT
N 021001 001 5565447 May 07, 2015 DS DP U-969
ALMOTRIPTAN MALATE - AXERT
N 021001 002 5565447 May 07, 2015 DS DP U-969
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 5 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALOGLIPTIN BENZOATE - NESINA
N 022271 001 6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6211205 Jun 19, 2016 U-1331
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
ALOGLIPTIN BENZOATE - NESINA
N 022271 002 6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6211205 Jun 19, 2016 U-1331
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
ALOGLIPTIN BENZOATE - NESINA
N 022271 003 6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6211205 Jun 19, 2016 U-1331
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 6 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - KAZANO
N 203414 001 5965584 Jun 19, 2016 U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - KAZANO
N 203414 002 5965584 Jun 19, 2016 U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 7 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 001 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 002 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 003 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 8 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 004 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 005 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 006 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
ALOSETRON HYDROCHLORIDE - LOTRONEX
N 021107 001 6284770 Oct 05, 2018 U-405
ALOSETRON HYDROCHLORIDE - LOTRONEX
N 021107 002 6284770 Oct 05, 2018 U-405
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 9 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALPRAZOLAM - NIRAVAM
N 021726 001 6024981
6221392
ALPRAZOLAM - NIRAVAM
Apr 09, 2018
Apr 09, 2018
DP
DP
N 021726 002 6024981
6221392
ALPRAZOLAM - NIRAVAM
Apr 09, 2018
Apr 09, 2018
DP
DP
N 021726 003 6024981
6221392
ALPRAZOLAM - NIRAVAM
Apr 09, 2018
Apr 09, 2018
DP
DP
N 021726 004 6024981
6221392
ALPROSTADIL - CAVERJECT
Apr 09, 2018
Apr 09, 2018
DP
DP
N 020379 001 5741523
ALPROSTADIL - CAVERJECT
Apr 21, 2015
N 020379 002 5741523
ALPROSTADIL - CAVERJECT
Apr 21, 2015
N 020379 003 5741523
ALPROSTADIL - CAVERJECT
Apr 21, 2015
N 020379 004 5741523
ALPROSTADIL - MUSE
Apr 21, 2015
N 020700 001 5886039 Mar 23, 2016 DP U-155
ALPROSTADIL - MUSE
N 020700 002 5886039 Mar 23, 2016 DP U-155
ALPROSTADIL - MUSE
N 020700 003 5886039 Mar 23, 2016 DP U-155
ALPROSTADIL - MUSE
N 020700 004 5886039 Mar 23, 2016 DP U-155
ALPROSTADIL - CAVERJECT IMPULSE
N 021212 001 5716338 Feb 10, 2015 DP
ALPROSTADIL - CAVERJECT IMPULSE
N 021212 002 5716338 Feb 10, 2015 DP
ALVIMOPAN - ENTEREG
N 021775 001 5250542
5434171
6469030
8112290
Mar 29, 2016
Dec 08, 2013
Nov 29, 2020
Jul 31, 2030
DS DP U-878
DS DP U-878
U-879
DP U-1443
M-128 Oct 18, 2016
AMBRISENTAN - LETAIRIS
N 022081 001 5703017
5840722
5840722
7109205
7601730
8349843
RE42462
Dec 30, 2014
Nov 24, 2015
Nov 24, 2015
Oct 07, 2015
Oct 07, 2015
Oct 07, 2015
Jul 29, 2018
DS
U-821
U-1297
DS DP
U-1080
DS DP
DS
ODE Jun 15, 2014
AMBRISENTAN - LETAIRIS
N 022081 002 5703017
5840722
5840722
7109205
7601730
8349843
RE42462
Dec 30, 2014
Nov 24, 2015
Nov 24, 2015
Oct 07, 2015
Oct 07, 2015
Oct 07, 2015
Jul 29, 2018
DS
U-821
U-1297
DS DP
U-1080
DS DP
DS
ODE Jun 15, 2014
AMIFOSTINE - ETHYOL
N 020221 001 5994409 Dec 08, 2017 U-305
AMIFOSTINE - ETHYOL
N 020221 002 5994409 Dec 08, 2017 U-305
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 10 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AMINOLEVULINIC ACID HYDROCHLORIDE - LEVULAN
N 020965 001 5079262 Sep 30, 2013 U-289
5954703 Oct 31, 2017 U-289
6709446 May 01, 2018 U-289
7723910 Jun 17, 2019 U-289
8216289 May 01, 2018 U-289
AMIODARONE HYDROCHLORIDE - NEXTERONE
N 022325 001 6869939 May 04, 2022 DP
7635773 Mar 13, 2029 DP
AMIODARONE HYDROCHLORIDE - NEXTERONE
N 022325 002 6869939 May 04, 2022 DP
7635773 Mar 13, 2029 DP
AMIODARONE HYDROCHLORIDE - NEXTERONE
N 022325 003 6869939 May 04, 2022 DP
7635773 Mar 13, 2029 DP
AMLODIPINE BESYLATE - AMLODIPINE BESYLATE
N 022026 001 6828339 Nov 20, 2022 DS
AMLODIPINE BESYLATE - AMLODIPINE BESYLATE
N 022026 002 6828339 Nov 20, 2022 DS
AMLODIPINE BESYLATE - AMLODIPINE BESYLATE
N 022026 003 6828339 Nov 20, 2022 DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 11 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 001 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 002 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 003 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 004 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 005 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 006 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 007 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 008 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 009 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 010 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 011 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 002 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 003 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 004 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 005 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 006 6162802 Dec 19, 2017 DS DP U-185
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 007 6162802 Dec 19, 2017 DS DP U-185
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 12 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 001 5616599 Apr 25, 2016 DS DP U-3 NC Jul 23, 2013
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 002 5616599 Apr 25, 2016 DS DP U-3 NC Jul 23, 2013
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 003 5616599 Apr 25, 2016 DS DP U-3 NC Jul 23, 2013
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 004 5616599 Apr 25, 2016 DS DP U-3 NC Jul 23, 2013
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 005 5616599 Apr 25, 2016 DS DP U-3 NC Jul 23, 2013
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N 022314 001 6294197
8101599
8475839
8475839*PED
Jun 18, 2017
May 16, 2023
May 16, 2023
Nov 16, 2023
DP U-3
DP
DP
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N 022314 002 6294197
8101599
8475839
8475839*PED
Jun 18, 2017
May 16, 2023
May 16, 2023
Nov 16, 2023
DP U-3
DP
DP
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N 022314 003 6294197
8101599
8475839
8475839*PED
Jun 18, 2017
May 16, 2023
May 16, 2023
Nov 16, 2023
DP U-3
DP
DP
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N 022314 004 6294197
8101599
8475839
8475839*PED
Jun 18, 2017
May 16, 2023
May 16, 2023
Nov 16, 2023
DP U-3
DP
DP
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N 022314 005 6294197
8101599
8475839
8475839*PED
Jun 18, 2017
May 16, 2023
May 16, 2023
Nov 16, 2023
DP U-3
DP
DP
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N 022100 001 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N 022100 002 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N 022100 003 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N 022100 004 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA
N 022401 001 5591762 Jan 07, 2014 DS DP U-3
AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA
N 022401 002 5591762 Jan 07, 2014 DS DP U-3
AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA
N 022401 003 5591762 Jan 07, 2014 DS DP U-3
AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA
N 022401 004 5591762 Jan 07, 2014 DS DP U-3
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 13 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N 021990 002 6294197 Jun 18, 2017 DP U-3
6395728 Jul 08, 2019 DP
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N 021990 003 6294197 Jun 18, 2017 DP U-3
6395728 Jul 08, 2019 DP
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N 021990 004 6294197 Jun 18, 2017 DP U-3
6395728 Jul 08, 2019 DP
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N 021990 005 6294197 Jun 18, 2017 DP U-3
6395728 Jul 08, 2019 DP
AMOXICILLIN - MOXATAG
N 050813 001 6544555 Oct 13, 2020 DS DP U-897
6669948 Oct 13, 2020 DS DP U-897
6723341 Oct 13, 2020 DS DP U-897
8299052 May 07, 2027 U-1304
8357394 Dec 08, 2026 DP
AMOXICILLIN; CLAVULANATE POTASSIUM - AUGMENTIN XR
N 050785 001 6746692 Apr 04, 2020 DP
6783773 Apr 04, 2020 DP
6878386 Apr 04, 2020 U-926
7217430 Apr 04, 2020 DP U-926
7250176 Apr 04, 2020 U-926
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 10
N 011522 007 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 20
N 011522 008 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 5
N 011522 009 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 30
N 011522 010 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 7.5
N 011522 011 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 12.5
N 011522 012 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 15
N 011522 013 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 10
N 021303 001 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 20
N 021303 002 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 14 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 30
N 021303 003 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 25
N 021303 004 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 5
N 021303 005 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 15
N 021303 006 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
AMPHOTERICIN B - ABELCET
N 050724 001 5616334 Apr 01, 2014 DS
6406713 Jun 18, 2019 DS
AMPHOTERICIN B - AMBISOME
N 050740 001 5874104 Feb 23, 2016 DP U-922
5965156 Oct 12, 2016 DP U-922
AMPRENAVIR - AGENERASE
N 021007 001 5585397 Dec 17, 2013
5646180 Jul 08, 2014 U-257
5723490 Mar 03, 2015 U-257
6730679 Nov 11, 2017 DP
AMPRENAVIR - AGENERASE
N 021007 002 5585397 Dec 17, 2013
5646180 Jul 08, 2014 U-257
5723490 Mar 03, 2015 U-257
6730679 Nov 11, 2017 DP
AMPRENAVIR - AGENERASE
N 021039 001 5585397 Dec 17, 2013
5646180 Jul 08, 2014 U-257
5723490 Mar 03, 2015 U-257
ANIDULAFUNGIN - ERAXIS
N 021632 001 5965525 Feb 17, 2020 DS DP U-540
6960564 Apr 12, 2021 DP U-540
7709444 Apr 12, 2021 DP U-540
ANIDULAFUNGIN - ERAXIS
N 021632 002 5965525 Feb 17, 2020 DS DP U-540
6960564 Apr 12, 2021 DP U-540
7709444 Apr 12, 2021 DP U-540
APIXABAN - ELIQUIS
N 202155 001 6413980
6967208
6967208
Dec 22, 2019
Feb 03, 2023
Feb 03, 2023
DS DP U-1200
DS DP U-1200
DS DP U-1323
NCE Dec 28, 2017
APIXABAN - ELIQUIS
N 202155 002 6413980
6967208
6967208
Dec 22, 2019
Feb 03, 2023
Feb 03, 2023
DS DP U-1200
DS DP U-1200
DS DP U-1323
NCE Dec 28, 2017
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 15 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
APREPITANT - EMEND
N 021549 001 5538982 Jul 23, 2013 U-745
5719147 Apr 17, 2015 DS DP U-853
6096742 Jul 01, 2018 DS DP U-745
8258132 Sep 26, 2027 DP U-901
8258132 Sep 26, 2027 DP U-1282
APREPITANT - EMEND
N 021549 002 5538982 Jul 23, 2013 U-745
5719147 Apr 17, 2015 DS DP U-853
6096742 Jul 01, 2018 DS DP U-745
8258132 Sep 26, 2027 DP U-901
8258132 Sep 26, 2027 DP U-1282
APREPITANT - EMEND
N 021549 003 5538982 Jul 23, 2013 U-745
5719147 Apr 17, 2015 DS DP U-853
6096742 Jul 01, 2018 DS DP U-745
8258132 Sep 26, 2027 DP U-901
8258132 Sep 26, 2027 DP U-1282
ARFORMOTEROL TARTRATE - BROVANA
N 021912 001 6040344 Nov 12, 2016 DS
6472563 Nov 09, 2021 DS
6589508 Apr 03, 2014 U-793
6667344 Jun 22, 2021 DP
6720453 Nov 09, 2021 DS
6814953 Jun 22, 2021 U-793
7145036 Nov 09, 2021 DS
7348362 Jun 22, 2021 DP U-793
7462645 Jun 22, 2021 U-793
7465756 Jun 22, 2021 DP
7473710 Jun 22, 2021 U-793
7541385 Jun 22, 2021 U-793
8110706 Nov 09, 2021 DP
ARGATROBAN - ACOVA
N 020883 001 5214052 Jun 30, 2014
ARGATROBAN - ARGATROBAN IN SODIUM CHLORIDE
N 022434 001 7589106 Sep 26, 2027 DP U-1163
7687516 Sep 26, 2027 DP U-1164
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 16 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PATENT
EXPIRATION PATENT
PATENT
DELIST EXCLUSIVITY
EXCLUSIVITY
EXPIRATION
ARIPIPRAZOLE - ABILIFY
DATE CODES REQUESTED CODE(S) DATE
N 021436 001 5006528
7053092
8017615
8017615*PED
8580796
8580796*PED
Oct 20, 2014
Jan 28, 2022
Jun 16, 2024
Dec 16, 2024
Sep 25, 2022
Mar 25, 2023
DS DP U-761
U-839
DP
DS
I-633 Feb 16, 2014
ARIPIPRAZOLE - ABILIFY
N 021436 002 5006528
7053092
8017615
8017615*PED
8580796
8580796*PED
Oct 20, 2014
Jan 28, 2022
Jun 16, 2024
Dec 16, 2024
Sep 25, 2022
Mar 25, 2023
DS DP U-761
U-839
DP
DS
I-633 Feb 16, 2014
ARIPIPRAZOLE - ABILIFY
N 021436 003 5006528
7053092
8017615
8017615*PED
8580796
8580796*PED
Oct 20, 2014
Jan 28, 2022
Jun 16, 2024
Dec 16, 2024
Sep 25, 2022
Mar 25, 2023
DS DP U-761
U-839
DP
DS
I-633 Feb 16, 2014
ARIPIPRAZOLE - ABILIFY
N 021436 004 5006528
7053092
8017615
8017615*PED
8580796
8580796*PED
Oct 20, 2014
Jan 28, 2022
Jun 16, 2024
Dec 16, 2024
Sep 25, 2022
Mar 25, 2023
DS DP U-761
U-839
DP
DS
I-633 Feb 16, 2014
ARIPIPRAZOLE - ABILIFY
N 021436 005 5006528
7053092
8017615
8017615*PED
8580796
8580796*PED
Oct 20, 2014
Jan 28, 2022
Jun 16, 2024
Dec 16, 2024
Sep 25, 2022
Mar 25, 2023
DS DP U-761
U-839
DP
DS
I-633 Feb 16, 2014
ARIPIPRAZOLE - ABILIFY
N 021436 006 5006528
7053092
8017615
8017615*PED
8580796
8580796*PED
Oct 20, 2014
Jan 28, 2022
Jun 16, 2024
Dec 16, 2024
Sep 25, 2022
Mar 25, 2023
DS DP U-761
U-839
DP
DS
I-633 Feb 16, 2014
ARIPIPRAZOLE - ABILIFY
N 021713 001 5006528
6977257
7053092
Oct 20, 2014
Apr 24, 2022
Jan 28, 2022
DS DP U-761
DS DP
U-839
I-633 Feb 16, 2014
ARIPIPRAZOLE - ABILIFY
N 021729 002 5006528
7053092
8017615
8017615*PED
8518421
8518421*PED
8580796
8580796*PED
Oct 20, 2014
Jan 28, 2022
Jun 16, 2024
Dec 16, 2024
Jan 24, 2021
Jul 24, 2021
Sep 25, 2022
Mar 25, 2023
DS DP U-761
U-839
DP
DP
DS
I-633 Feb 16, 2014
ARIPIPRAZOLE - ABILIFY
N 021729 003 5006528
7053092
8017615
8017615*PED
8518421
8518421*PED
8580796
8580796*PED
Oct 20, 2014
Jan 28, 2022
Jun 16, 2024
Dec 16, 2024
Jan 24, 2021
Jul 24, 2021
Sep 25, 2022
Mar 25, 2023
DS DP U-761
U-839
DP
DP
DS
I-633 Feb 16, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 17 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PATENT
EXPIRATION PATENT
PATENT
DELIST EXCLUSIVITY
EXCLUSIVITY
EXPIRATION
ARIPIPRAZOLE - ABILIFY
DATE CODES REQUESTED CODE(S) DATE
N 021729 004 5006528
7053092
8017615
8017615*PED
8518421
8518421*PED
8580796
8580796*PED
Oct 20, 2014
Jan 28, 2022
Jun 16, 2024
Dec 16, 2024
Jan 24, 2021
Jul 24, 2021
Sep 25, 2022
Mar 25, 2023
DS DP U-761
U-839
DP
DP
DS
ARIPIPRAZOLE - ABILIFY
N 021729 005 5006528
7053092
8017615
8017615*PED
8518421
8518421*PED
8580796
8580796*PED
Oct 20, 2014
Jan 28, 2022
Jun 16, 2024
Dec 16, 2024
Jan 24, 2021
Jul 24, 2021
Sep 25, 2022
Mar 25, 2023
DS DP U-761
U-839
DP
DP
DS
ARIPIPRAZOLE - ABILIFY
N 021866 001 5006528
7115587
7550445
Oct 20, 2014
Jul 21, 2024
Jul 21, 2024
DS DP U-763
DS DP U-764
DP
I-633 Feb 16, 2014
ARIPIPRAZOLE - ABILIFY MAINTENA KIT
N 202971 001 5006528
7807680
8030313
8338427
8338428
8399469
Apr 20, 2015
Oct 19, 2024
Oct 19, 2024
Mar 15, 2025
Aug 06, 2023
Dec 29, 2023
DS DP U-543
DP
U-543
DP U-543
DP U-543
DS
NDF Feb 28, 2016
ARIPIPRAZOLE - ABILIFY MAINTENA KIT
N 202971 002 5006528
7807680
8030313
8338427
8338428
8399469
Apr 20, 2015
Oct 19, 2024
Oct 19, 2024
Mar 15, 2025
Aug 06, 2023
Dec 29, 2023
DS DP U-543
DP
U-543
DP U-543
DP U-543
DS
NDF Feb 28, 2016
ARMODAFINIL - NUVIGIL
N 021875 001 7132570
7297346
RE37516
Dec 18, 2023
Nov 29, 2023
Oct 06, 2014
DS DP
DP
DP U-820
ARMODAFINIL - NUVIGIL
N 021875 002 7132570
7297346
RE37516
Dec 18, 2023
Nov 29, 2023
Oct 06, 2014
DS DP
DP
DP U-820
ARMODAFINIL - NUVIGIL
N 021875 003 7132570
7297346
RE37516
Dec 18, 2023
Nov 29, 2023
Oct 06, 2014
DS DP
DP
DP U-820
ARMODAFINIL - NUVIGIL
N 021875 004 7132570
7297346
RE37516
Dec 18, 2023
Nov 29, 2023
Oct 06, 2014
DS DP
DP
DP U-820
ARMODAFINIL - NUVIGIL
N 021875 005 7132570
7297346
RE37516
Dec 18, 2023
Nov 29, 2023
Oct 06, 2014
DS DP
DP
DP U-820
ARSENIC TRIOXIDE - TRISENOX
N 021248 001 6723351
6855339
6861076
6884439
6982096
8273379
Nov 10, 2018
Nov 10, 2018
Nov 10, 2018
Nov 10, 2018
Nov 10, 2018
Nov 10, 2018
U-573
U-617
U-617
U-651
U-651
U-1291
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 18 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ARTEMETHER; LUMEFANTRINE - COARTEM
N 022268 001 5677331 Oct 14, 2014 DP U-977 NCE Apr 07, 2014
ODE Apr 07, 2016
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM
SULFATE - MOVIPREP
N 021881 001 7169381 Sep 01, 2024 DS DP
7658914 Sep 01, 2024 DS DP
ASENAPINE MALEATE - SAPHRIS
N 022117 001 5763476 Jun 09, 2020 DP U-326 I-628 Sep 03, 2013
7741358 Apr 06, 2026 DS DP U-1064 I-629 Sep 03, 2013
NCE Aug 13, 2014
ASENAPINE MALEATE - SAPHRIS
N 022117 002 5763476 Jun 09, 2020 DP U-326 I-628 Sep 03, 2013
7741358 Apr 06, 2026 DS DP U-1064 I-629 Sep 03, 2013
NCE Aug 13, 2014
ASPIRIN; DIPYRIDAMOLE - AGGRENOX
N 020884 001 6015577 Jan 18, 2017 U-302
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
N 021387 001 5622985 Apr 22, 2014 U-335
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
N 021387 002 5622985 Apr 22, 2014 U-335
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
N 021387 003 5622985 Apr 22, 2014 U-335
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
N 021387 004 5622985 Apr 22, 2014 U-335
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
N 021387 005 5622985 Apr 22, 2014 U-335
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
N 021387 006 5622985
ATAZANAVIR SULFATE - REYATAZ
N 021567 001 5849911
6087383
ATAZANAVIR SULFATE - REYATAZ
N 021567 002 5849911
6087383
ATAZANAVIR SULFATE - REYATAZ
N 021567 003 5849911
6087383
ATAZANAVIR SULFATE - REYATAZ
N 021567 004 5849911
6087383
Apr 22, 2014 U-335
Jun 20, 2017
Dec 21, 2018
DS DP U-167
DS DP
D-130 Feb 04, 2014
Jun 20, 2017
Dec 21, 2018
DS DP U-167
DS DP
D-130 Feb 04, 2014
Jun 20, 2017
Dec 21, 2018
DS DP U-167
DS DP
D-130 Feb 04, 2014
Jun 20, 2017
Dec 21, 2018
DS DP U-167
DS DP
D-130 Feb 04, 2014
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 001 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 002 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 003 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 004 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 005 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 006 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 007 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 008 5658590 Nov 26, 2016 U-494
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 19 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ATORVASTATIN CALCIUM - LIPITOR
N 020702 001 5686104
5969156
ATORVASTATIN CALCIUM - LIPITOR
Nov 11, 2014
Jul 08, 2016
DP U-213
DS
N 020702 002 5686104
5969156
ATORVASTATIN CALCIUM - LIPITOR
Nov 11, 2014
Jul 08, 2016
DP U-213
DS
N 020702 003 5686104
5969156
ATORVASTATIN CALCIUM - LIPITOR
Nov 11, 2014
Jul 08, 2016
DP U-213
DS
N 020702 004 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET
N 200153 001 5846966 Sep 21, 2013 DP U-1400
5846966*PED Mar 21, 2014
RE42461 Oct 25, 2016 DS DP U-1400
RE42461*PED Apr 25, 2017
ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET
N 200153 002 5846966 Sep 21, 2013 DP U-1400
5846966*PED Mar 21, 2014
RE42461 Oct 25, 2016 DS DP U-1400
RE42461*PED Apr 25, 2017
ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET
N 200153 003 5846966 Sep 21, 2013 DP U-1400
5846966*PED Mar 21, 2014
RE42461 Oct 25, 2016 DS DP U-1400
RE42461*PED Apr 25, 2017
ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET
N 200153 004 5846966 Sep 21, 2013 DP U-1400
5846966*PED Mar 21, 2014
RE42461 Oct 25, 2016 DS DP U-1400
RE42461*PED Apr 25, 2017
ATOVAQUONE - MEPRON
N 020500 001 6649659 Jul 10, 2016 DS DP U-69
ATOVAQUONE; PROGUANIL HYDROCHLORIDE - MALARONE
N 021078 001 5998449 Nov 25, 2013 U-990
6166046 Nov 25, 2013 U-406
6291488 Nov 25, 2013 U-406
ATOVAQUONE; PROGUANIL HYDROCHLORIDE - MALARONE PEDIATRIC
N 021078 002 5998449 Nov 25, 2013 U-990
6166046 Nov 25, 2013
6291488 Nov 25, 2013 U-406
AVANAFIL - STENDRA
NC
NC
NC
NC
May 03, 2016
May 03, 2016
May 03, 2016
May 03, 2016
N 202276 001 6656935
7501409
AVANAFIL - STENDRA
Sep 13, 2020
May 05, 2023
DS DP U-155
DP
NCE Apr 27, 2017
N 202276 002 6656935
7501409
AVANAFIL - STENDRA
Sep 13, 2020
May 05, 2023
DS DP U-155
DP
NCE Apr 27, 2017
N 202276 003 6656935 Sep 13, 2020
7501409 May 05, 2023
AVOBENZONE; ECAMSULE; OCTOCRYLENE - ANTHELIOS SX
N 021502 001 5587150 Dec 24, 2013
AXITINIB - INLYTA
DS DP U-155
DP
DP U-752
NCE Apr 27, 2017
N 202324 001 6534524
7141581
Jun 30, 2020
Jun 30, 2020
DS DP
U-1220
NCE Jan 27, 2017
AXITINIB - INLYTA
N 202324 002 6534524
7141581
Jun 30, 2020
Jun 30, 2020
DS DP
U-1220
NCE Jan 27, 2017
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 20 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AZELAIC ACID - FINACEA
N 021470 001 6534070 Nov 18, 2018
AZELASTINE HYDROCHLORIDE - ASTEPRO
N 022203 001 8071073 Jun 04, 2028
8518919 Nov 22, 2025
AZELASTINE HYDROCHLORIDE - ASTEPRO
DP
U-1430
M-129
NPP
Aug 30, 2016
Aug 30, 2016
N 022371 001 8071073
8518919
Jun 04, 2028
Nov 22, 2025
DP
U-1430
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE - DYMISTA
N 202236 001 8163723 Aug 29, 2023 U-77
8163723 Aug 29, 2023 U-81
8163723 Aug 29, 2023 U-644
8163723 Aug 29, 2023 U-707
8168620 Feb 24, 2026 DP
NC May 01, 2015
AZILSARTAN KAMEDOXOMIL - EDARBI
N 200796 001 5583141
5958961
7157584
7572920
Dec 10, 2013
Jun 06, 2014
May 22, 2025
Jan 07, 2025
DS DP U-3
DP U-3
DS
DP U-3
NCE Feb 25, 2016
AZILSARTAN KAMEDOXOMIL - EDARBI
N 200796 002 5583141
5958961
7157584
7572920
Dec 10, 2013
Jun 06, 2014
May 22, 2025
Jan 07, 2025
DS DP U-3
DP U-3
DS
DP U-3
NCE Feb 25, 2016
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR
N 202331 001 5583141 Dec 10, 2013 DS DP U-3
7157584 May 22, 2025 DS
7572920 Jan 07, 2025 DP U-3
NC
NCE
Dec 20, 2014
Feb 25, 2016
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR
N 202331 002 5583141 Dec 10, 2013 DS DP U-3
7157584 May 22, 2025 DS
7572920 Jan 07, 2025 DP U-3
NC
NCE
Dec 20, 2014
Feb 25, 2016
AZITHROMYCIN - ZITHROMAX
N 050693 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050710 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050710 002 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050711 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050730 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050733 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050784 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZMAX
N 050797 001 6068859
6268489
6984403
7887844
May 30, 2017
Jul 31, 2018
Feb 14, 2024
Feb 14, 2024
DP
DS
DP U-282
DP
AZITHROMYCIN - AZASITE
N 050810 001 6159458
6239113
6569443
6861411
7056893
Nov 04, 2017
Mar 31, 2019
Mar 31, 2019
Nov 25, 2018
Mar 31, 2019
DP U-709
U-709
DP U-709
U-709
DP U-709
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 21 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AZTREONAM - CAYSTON
N 050814 001 7208141 Dec 20, 2021 DP U-1031 ODE Feb 22, 2017
7214364 Dec 20, 2021 DP
7427633 Dec 20, 2021 DP U-1031
8399496 Dec 20, 2021 DP U-1377
BACLOFEN - KEMSTRO
N 021589 001 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
BACLOFEN - KEMSTRO
N 021589 002 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
BALSALAZIDE DISODIUM - COLAZAL
N 020610 001 7452872 Aug 24, 2026 U-141 ODE Dec 20, 2013
7625884 Aug 24, 2026 U-141 PED Jun 20, 2014
BALSALAZIDE DISODIUM - GIAZO
N 022205 001 6197341 Mar 13, 2018 DP U-1229 NDF Feb 03, 2015
7452872 Aug 24, 2026 U-1229
7625884 Aug 24, 2026 U-1229
8497256 Jun 23, 2031 U-1229
BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED - DUAVEE
N 022247 001 5998402 Apr 04, 2017 DS DP U-594
6479535 May 06, 2019 DP U-594
6479535 May 06, 2019 DP U-904
7138392 Apr 04, 2017 DS DP U-594
7683051 Mar 10, 2027 DS DP U-594
7683051 Mar 10, 2027 DS DP U-904
BECLOMETHASONE DIPROPIONATE - QVAR 80
N 020911 001 5605674 Feb 25, 2014
5683677 Nov 04, 2014
5776432 Jul 07, 2015
BECLOMETHASONE DIPROPIONATE - QVAR 40
N 020911 002 5605674 Feb 25, 2014
5683677 Nov 04, 2014
5776432 Jul 07, 2015
BECLOMETHASONE DIPROPIONATE - QNASL
N 202813 001 5605674 Feb 25, 2014 DP NP Mar 23, 2015
5683677 Nov 04, 2014 DP
5776432 Jul 07, 2015 DP
7780038 Jan 24, 2027 DP
BEDAQUILINE FUMARATE - SIRTURO
N 204384 001 7498343 Oct 02, 2024 DS DP U-1321 NCE Dec 28, 2017
ODE Dec 28, 2019
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 22 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N 022249 001 8436190 Oct 26, 2030 DP ODE Oct 31, 2015
8436190*PED Apr 26, 2031 ODE Mar 20, 2015
8445524 Mar 26, 2029 DS DP U-1402 PED Sep 20, 2015
8445524*PED Sep 26, 2029 PED May 01, 2016
8609863 Jan 12, 2026 DP PED Sep 20, 2013
8609863*PED Jul 12, 2026
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N 022249 002 8436190 Oct 26, 2030 DP ODE Mar 20, 2015
8436190*PED Apr 26, 2031 ODE Oct 31, 2015
8445524 Mar 26, 2029 DS DP U-1402 PED Sep 20, 2015
8445524*PED Sep 26, 2029 PED Sep 20, 2013
8609863 Jan 12, 2026 DP PED May 01, 2016
8609863*PED Jul 12, 2026
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N 022249 003 8344006 Sep 23, 2029 DP U-1402 ODE Oct 31, 2015
8344006*PED Mar 23, 2030 ODE Mar 20, 2015
8445524 Mar 26, 2029 DS PED Sep 20, 2015
8445524*PED Sep 26, 2029 PED May 01, 2016
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N 022249 004 8344006 Sep 23, 2029 DP U-1402 ODE Oct 31, 2015
8344006*PED Mar 23, 2030 ODE Mar 20, 2015
8445524 Mar 26, 2029 DS PED May 01, 2016
8445524*PED Sep 26, 2029 PED Sep 20, 2015
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - DUAC
N 050741 001 5466446 Feb 16, 2014 DS DP
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ACANYA
N 050819 001 5733886 Mar 31, 2015 DP U-124
8288434 Aug 05, 2029 DP U-124
BENZYL ALCOHOL - ULESFIA
N 022129 001 5858383 Aug 11, 2017 U-970 NCE Apr 09, 2014
6139859 Aug 11, 2017 U-970
6793931 Jul 11, 2022 DP U-970
7294342 May 19, 2024 U-970
BEPOTASTINE BESILATE - BEPREVE
N 022288 001 6780877 Sep 19, 2019 DS DP NCE Sep 08, 2014
BESIFLOXACIN HYDROCHLORIDE - BESIVANCE
N 022308 001 5447926 Apr 13, 2016 DS DP U-80 NCE May 28, 2014
6685958 Jun 29, 2021 DP U-80
6699492 Mar 31, 2019 DP U-80
8415342 Nov 07, 2030 U-80
8481526 Jan 09, 2031 DS
8604020 Mar 12, 2030 DP
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE - TACLONEX
N 021852 001 5763426 Jun 09, 2015 DS DP
6753013 Jan 27, 2020 DP U-88
6753013 Jan 27, 2020 DP U-193
RE39706 Jun 09, 2015 DS DP
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE - TACLONEX
N 022185 001 6753013 Jan 27, 2020 DP U-88 I-659 Oct 17, 2015
6753013 Jan 27, 2020 DP U-193
6787529 Jan 27, 2020 DP U-88
6787529 Jan 27, 2020 DP U-193
RE39706 Jun 09, 2015 DS DP
BETAMETHASONE VALERATE - LUXIQ
N 020934 001 6126920 Mar 01, 2016 U-484
7078058 May 24, 2017 DP
BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE - BETOPTIC PILO
N 020619 001 5635172 Jun 03, 2014 U-191
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 23 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BEXAROTENE - TARGRETIN
N 021055 001 5780676 Jul 14, 2015 U-509
5962731 Oct 05, 2016 U-475
BEXAROTENE - TARGRETIN
N 021056 001 5780676 Jul 14, 2015 U-510
5962731 Oct 05, 2016
BIMATOPROST - LUMIGAN
N 021275 001 5688819 Aug 19, 2014 U-446
BIMATOPROST - LUMIGAN
N 022184 001 5688819 Aug 19, 2014 U-1081 NP Aug 31, 2013
7851504 Jun 13, 2027 DS DP
8278353 Mar 16, 2025 DP
8299118 Mar 16, 2025 U-1295
8309605 Mar 16, 2025 U-1293
8309605 Mar 16, 2025 U-1294
8338479 Mar 16, 2025 DP U-1295
8524777 Mar 16, 2025 U-1235
8586630 Mar 16, 2025 U-1458
BIMATOPROST - LATISSE
N 022369 001 7351404 May 25, 2024 U-939
7388029 Jan 21, 2022 U-938
8038988 Aug 25, 2023 DS DP U-1208
8101161 May 25, 2024 U-1217
8101161 May 25, 2024 U-1218
8263054 Aug 25, 2023 U-1277
8541466 Jan 21, 2022 U-1217
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - HALFLYTELY
N 021551 003 7291324 Oct 22, 2022 U-837 NP Jul 16, 2013
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE - PYLERA
N 050786 001 6350468 Dec 14, 2018 U-932
6350468 Dec 14, 2018 U-956
BIVALIRUDIN - ANGIOMAX
N 020873 001 5196404 Dec 15, 2014 DS DP U-1040
5196404 Dec 15, 2014 DS DP U-1232
7582727 Jul 27, 2028 DP
7598343 Jul 27, 2028 DP
BOCEPREVIR - VICTRELIS
N 202258 001 7772178 Nov 11, 2027 DP U-1128 M-126 Feb 27, 2016
8119602 Mar 17, 2027 U-1233 NCE May 13, 2016
RE43298 Feb 22, 2022 DS DP U-1128 NPP Feb 13, 2016
BORTEZOMIB - VELCADE
N 021602 001 5780454 May 03, 2017 DP NR Jan 23, 2015
6083903 Oct 28, 2014 DP U-515
6297217 Oct 28, 2014 U-515
6297217 Oct 28, 2014 U-884
6297217 Oct 28, 2014 U-885
6617317 Oct 28, 2014 DS DP
6713446 Jan 25, 2022 DP
6747150 Oct 28, 2014 DP
6958319 Jan 25, 2022 DP
7119080 Oct 28, 2014 DP
BOSENTAN - TRACLEER
N 021290 001 5292740 Nov 20, 2015
BOSENTAN - TRACLEER
N 021290 002 5292740 Nov 20, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 24 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BOSUTINIB MONOHYDRATE - BOSULIF
N 203341 001 6002008
7417148
7767678
7919625
RE42376
BOSUTINIB MONOHYDRATE - BOSULIF
Mar 27, 2018
Jan 23, 2026
Nov 23, 2026
Dec 11, 2025
Sep 24, 2019
DS DP U-1284
U-1283
DS DP
DP
DS
NCE
ODE
Sep 04, 2017
Sep 04, 2019
N 203341 002 6002008
7417148
7767678
7919625
RE42376
Mar 27, 2018
Jan 23, 2026
Nov 23, 2026
Dec 11, 2025
Sep 24, 2019
DS DP U-1284
U-1283
DS DP
DP
DS
NCE
ODE
Sep 04, 2017
Sep 04, 2019
BRIMONIDINE TARTRATE - ALPHAGAN P
N 021262 001 6562873
6627210
6641834
6673337
Jul 10, 2021
Jul 18, 2021
Jul 28, 2021
Jul 26, 2021
DP
DP
DP
BRIMONIDINE TARTRATE - QOLIANA
N 021764 001 7265117 Aug 19, 2025 DP
BRIMONIDINE TARTRATE - ALPHAGAN P
N 021770 001 6562873
6627210
6641834
6673337
Jul 10, 2021
Jul 18, 2021
Jul 28, 2021
Jul 26, 2021
DP
DP
DP
DP
BRIMONIDINE TARTRATE - MIRVASO
N 204708 001 7439241
8053427
8163725
8231885
8410102
8426410
8513247
8513249
Aug 25, 2025
Jun 13, 2031
Jun 13, 2031
May 24, 2025
May 24, 2025
May 24, 2025
Mar 25, 2031
Mar 25, 2031
U-1428
DP U-1428
DP
DP
U-1428
U-1428
DP U-1428
DP U-1428
NDF Aug 23, 2016
BRIMONIDINE TARTRATE; BRINZOLAMIDE - SIMBRINZA
N 204251 001 6316441 Dec 07, 2019 U-778 NC Apr 19, 2016
BRIMONIDINE TARTRATE; TIMOLOL MALEATE - COMBIGAN
N 021398 001 7030149
7320976
7323463
7642258
8133890
8354409
Apr 19, 2022
Apr 19, 2022
Jan 19, 2023
Apr 19, 2022
Apr 19, 2022
Apr 19, 2022
U-849
U-849
DP
DS DP U-1024
U-1235
DP U-1371
Y
BROMFENAC SODIUM - BROMDAY
N 021664 002 NP Oct 16, 2013
BROMFENAC SODIUM - PROLENSA
N 203168 001 8129431 Sep 11, 2025 DS DP NP Apr 05, 2016
BROMOCRIPTINE MESYLATE - CYCLOSET
N 020866 001 5679685
5716957
7888310
8137992
8137993
8137994
8431155
Oct 21, 2014
Feb 10, 2015
Jul 25, 2023
Jul 25, 2023
Jul 25, 2023
Jul 25, 2023
Apr 30, 2032
DP
U-976
U-1433
U-1433
U-1433
U-1433
DP U-976
BUDESONIDE - RHINOCORT
N 020746 001 6291445
6686346
6986904
BUDESONIDE - RHINOCORT
Apr 29, 2017
Apr 29, 2017
Apr 29, 2017
DP U-557
DP U-699
Y
Y
Y
N 020746 002 6291445
6686346
6986904
Apr 29, 2017
Apr 29, 2017
Apr 29, 2017
DP U-557
DP U-699
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 25 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BUDESONIDE - PULMICORT RESPULES
N 020929 001 6598603
6899099
7524834
Dec 23, 2018
Dec 23, 2018
Nov 11, 2018
U-529
U-529
DP U-966
BUDESONIDE - PULMICORT RESPULES
N 020929 002 6598603
6899099
7524834
Dec 23, 2018
Dec 23, 2018
Nov 11, 2018
U-529
U-529
DP U-966
BUDESONIDE - PULMICORT RESPULES
N 020929 003 6598603
6899099
7524834
Dec 23, 2018
Dec 23, 2018
Nov 11, 2018
U-529
U-529
DP U-966
BUDESONIDE - ENTOCORT EC
N 021324 001 5643602 Jul 01, 2014 U-655
BUDESONIDE - PULMICORT FLEXHALER
N 021949 001 6027714
6142145
6287540
7143764
Jan 09, 2018
May 08, 2018
Jan 09, 2018
Mar 13, 2018
DP U-787
DP
DP
DP
BUDESONIDE - PULMICORT FLEXHALER
N 021949 002 6027714
6142145
6287540
7143764
Jan 09, 2018
May 08, 2018
Jan 09, 2018
Mar 13, 2018
DP U-787
DP
DP
DP
BUDESONIDE - UCERIS
N 203634 001 7410651
7431943
8293273
RE43799
Jun 09, 2020
Jun 09, 2020
Jun 09, 2020
Jun 09, 2020
DP U-1325
DP
DP
DP U-1325
NDF Jan 14, 2016
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT
N 021929 001 5674860
6123924
7367333
7587988
7759328
7967011
8143239
8387615
8528545
8575137
Oct 07, 2014
Sep 26, 2017
Nov 11, 2018
Apr 10, 2026
Jan 29, 2023
Aug 11, 2021
Jan 29, 2023
Nov 10, 2024
Oct 16, 2028
Jan 29, 2023
DP U-1075
DP
DP
DP
DP U-1073
DP
DP U-1073
DP
DP
DP U-1073
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT
N 021929 002 5674860
6123924
7367333
7587988
7759328
7897646
7967011
8143239
8387615
8461211
8528545
8575137
Oct 07, 2014
Sep 26, 2017
Nov 11, 2018
Apr 10, 2026
Jan 29, 2023
Sep 09, 2018
Aug 11, 2021
Jan 29, 2023
Nov 10, 2024
Sep 09, 2018
Oct 16, 2028
Jan 29, 2023
DP U-1075
DP
DP
DP
DP U-1073
U-1118
DP
DP U-1073
DP
U-1118
DP
DP U-1073
BUPIVACAINE - EXPAREL
N 022496 001 6132766
8182835
BUPIVACAINE - EXPAREL
Nov 16, 2013
Sep 18, 2018
DP
DP U-1246
NP Oct 28, 2014
N 022496 002 6132766
8182835
Nov 16, 2013
Sep 18, 2018
DP
DP U-1246
NP Oct 28, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 26 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BUPRENORPHINE - BUTRANS
N 021306 001 6264980 Dec 18, 2015 DP
6344211 Dec 18, 2015 U-1072
RE41408 Sep 29, 2017 U-1072
RE41489 Sep 29, 2017 U-1072
RE41571 Sep 29, 2017 U-1072
BUPRENORPHINE - BUTRANS
N 021306 002 6264980 Dec 18, 2015 DP
6344211 Dec 18, 2015 U-1072
RE41408 Sep 29, 2017 U-1072
RE41489 Sep 29, 2017 U-1072
RE41571 Sep 29, 2017 U-1072
BUPRENORPHINE - BUTRANS
N 021306 003 6264980 Dec 18, 2015 DP
6344211 Dec 18, 2015 U-1072
RE41408 Sep 29, 2017 U-1072
RE41489 Sep 29, 2017 U-1072
RE41571 Sep 29, 2017 U-1072
BUPRENORPHINE - BUTRANS
N 021306 004 6264980 Dec 18, 2015 DP
6344211 Dec 18, 2015 U-1072
RE41408 Sep 29, 2017 U-1072
RE41489 Sep 29, 2017 U-1072
RE41571 Sep 29, 2017 U-1072
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE
N 022410 001 8017150 Feb 13, 2023 DP NDF Aug 30, 2013
8475832 Mar 26, 2030 DP U-1411
8603514 Apr 03, 2024 DP U-1464
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE
N 022410 002 8017150 Feb 13, 2023 DP NDF Aug 30, 2013
8475832 Mar 26, 2030 DP U-1411
8603514 Apr 03, 2024 DP
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE
N 022410 003 8017150 Feb 13, 2023 DP NDF Aug 30, 2013
8475832 Mar 26, 2030 DP U-1411
8603514 Apr 03, 2024 DP
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE
N 022410 004 8017150 Feb 13, 2023 DP NDF Aug 30, 2013
8475832 Mar 26, 2030 DP U-1411
8603514 Apr 03, 2024 DP
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV
N 204242 001 8454996 Sep 24, 2019 U-1421
8470361 Oct 14, 2029 DP U-1425
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV
N 204242 002 8454996 Sep 24, 2019 U-1421
8470361 Oct 14, 2029 DP U-1425
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 27 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BUPROPION HYDROBROMIDE - APLENZIN
N 022108 001 7241805 Jun 27, 2026 DP
7569610 Jun 27, 2026 U-997
7572935 Jun 27, 2026 DP
7585897 Jun 27, 2026 DP
7645802 Jun 27, 2026 DP
7649019 Jun 27, 2026 DP
7662407 Jun 27, 2026 DP
7671094 Jun 27, 2026 DP
BUPROPION HYDROBROMIDE - APLENZIN
N 022108 002 7241805 Jun 27, 2026 DP
7569610 Jun 27, 2026 U-997
7572935 Jun 27, 2026 DP
7585897 Jun 27, 2026 DP
7645802 Jun 27, 2026 DP
7649019 Jun 27, 2026 DP
7662407 Jun 27, 2026 DP
7671094 Jun 27, 2026 DP
BUPROPION HYDROBROMIDE - APLENZIN
N 022108 003 7241805 Jun 27, 2026 DP
7569610 Jun 27, 2026 U-997
7572935 Jun 27, 2026 DP
7585897 Jun 27, 2026 DP
7645802 Jun 27, 2026 DP
7649019 Jun 27, 2026 DP
7662407 Jun 27, 2026 DP
7671094 Jun 27, 2026 DP
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
N 020358 001 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
N 020358 002 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
N 020358 003 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
N 020358 004 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUPROPION HYDROCHLORIDE - ZYBAN
N 020711 002 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUPROPION HYDROCHLORIDE - ZYBAN
N 020711 003 5358970 Aug 12, 2013
5427798 Aug 12, 2013
5731000 Aug 12, 2013
5763493 Aug 12, 2013
BUPROPION HYDROCHLORIDE - WELLBUTRIN XL
N 021515 001 6096341 Oct 30, 2018
BUPROPION HYDROCHLORIDE - WELLBUTRIN XL
N 021515 002 6096341 Oct 30, 2018
BUPROPION HYDROCHLORIDE - FORFIVO XL
N 022497 001 7674479 Jun 25, 2027 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 28 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BUSULFAN - BUSULFEX
N 020954 001 5430057 Sep 30, 2013
5559148 Sep 30, 2013
BUTOCONAZOLE NITRATE - GYNAZOLE-1
U-263
U-264
N 019881 001 5993856 Nov 17, 2017 DP U-457
CABAZITAXEL - JEVTANA KIT
N 201023 001 5438072
5847170
6331635
6372780
6387946
7241907
Nov 22, 2013
Mar 26, 2016
Mar 26, 2016
Mar 26, 2016
Mar 26, 2016
Dec 10, 2025
DP
DS DP
DS DP
U-1067
U-1067
DS
NCE Jun 17, 2015
CABOZANTINIB S-MALATE - COMETRIQ
N 203756 001 7579473 Sep 24, 2024 DS DP NCE
ODE
Nov 29, 2017
Nov 29, 2019
CABOZANTINIB S-MALATE - COMETRIQ
N 203756 002 7579473 Sep 24, 2024 DS DP NCE
ODE
Nov 29, 2017
Nov 29, 2019
CALCIPOTRIENE - DOVONEX
N 020554 001 5763426
RE39706
Jun 09, 2015
Jun 09, 2015
DS DP
DS DP
CALCIPOTRIENE - DOVONEX
N 020611 001 5763426
RE39706
Jun 09, 2015
Jun 09, 2015
DS DP
DS DP
CALCIPOTRIENE - SORILUX
N 022563 001 8263580 May 26, 2026 DP U-1280 I-657
NDF
Sep 27, 2015
Oct 06, 2013
CALCITONIN SALMON - MIACALCIN
N 020313 002 5733569
5759565
Mar 31, 2015
Mar 31, 2015
U-227
CALCITONIN SALMON RECOMBINANT - FORTICAL
N 021406 001 6440392
RE40812
RE43580
Feb 02, 2021
Feb 02, 2021
Feb 02, 2021
DP U-227
DP
DP U-227
CALCITRIOL - CALCIJEX
N 018874 001 6051567
6265392
6274169
CALCITRIOL - CALCIJEX
Aug 02, 2019
Aug 02, 2019
Aug 02, 2019
N 018874 002 6051567
6265392
6274169
CALCIUM ACETATE - PHOSLO
Aug 02, 2019
Aug 02, 2019
Aug 02, 2019
N 021160 002 6576665 Apr 03, 2021
CALCIUM ACETATE - PHOSLO GELCAPS
N 021160 003 6576665
CALCIUM ACETATE - PHOSLYRA
Apr 03, 2021
N 022581 001 8591938
8592480
Feb 23, 2030
Jul 20, 2027
DP U-1469
U-1469
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE - PEPCID COMPLETE
N 020958 001 5989588 Sep 30, 2015 U-349
6814978 Aug 26, 2021 DP
CALCIUM CARBONATE; RISEDRONATE SODIUM - ACTONEL WITH CALCIUM (COPACKAGED)
N 021823 001 5583122 Dec 10, 2013 DS DP U-353
5994329 Jul 17, 2018 U-353
6015801 Jul 17, 2018 U-353
6165513 Jun 10, 2018 DP
6432932 Jul 17, 2018 U-595
6465443 Aug 14, 2018 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 29 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;
SODIUM CHLORIDE; SODIUM PHOSPHATE - NAVSTEL
N 022193 001 7084130 Nov 29, 2021 DP U-891
CANAGLIFLOZIN - INVOKANA
N 204042 001 7943582
7943788
8222219
8513202
Feb 26, 2029
Jul 14, 2027
Jul 30, 2024
Dec 03, 2027
DS DP U-493
DS DP
U-493
DS DP U-493
NCE Mar 29, 2018
CANAGLIFLOZIN - INVOKANA
N 204042 002 7943582
7943788
8222219
8513202
Feb 26, 2029
Jul 14, 2027
Jul 30, 2024
Dec 03, 2027
DS DP U-493
DS DP
U-493
DS DP U-493
NCE Mar 29, 2018
CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL
A 078702 001 PC Jul 09, 2013
CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL
A 078702 002 PC Jul 09, 2013
CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL
A 078702 003 PC Jul 09, 2013
CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL
A 078702 004 PC Jul 09, 2013
CANDESARTAN CILEXETIL - ATACAND
N 020838 001 5534534 Jul 09, 2013 DP
CANDESARTAN CILEXETIL - ATACAND
N 020838 002 5534534 Jul 09, 2013 DP
CANDESARTAN CILEXETIL - ATACAND
N 020838 003 5534534 Jul 09, 2013 DP
CANDESARTAN CILEXETIL - ATACAND
N 020838 004 5534534 Jul 09, 2013 DP
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - AT
N 021093 001 5534534 Jul 09, 2013
5721263 Feb 24, 2015
5958961 Jun 06, 2014
ACAND HCT
DP
DP U-3
DP U-3
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - AT
N 021093 002 5534534 Jul 09, 2013
5721263 Feb 24, 2015
5958961 Jun 06, 2014
ACAND HCT
DP
DP U-3
DP U-3
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - AT
N 021093 003 5534534 Jul 09, 2013
5721263 Feb 24, 2015
5958961 Jun 06, 2014
ACAND HCT
DP
DP U-3
DP U-3
CAPECITABINE - XELODA
N 020896 001 5472949
5472949*PED
Dec 14, 2013
Jun 14, 2014
DS DP U-271 M-131
PED
Dec 10, 2016
Jun 10, 2017
CAPECITABINE - XELODA
N 020896 002 5472949
5472949*PED
Dec 14, 2013
Jun 14, 2014
DS DP U-271 M-131
PED
Dec 10, 2016
Jun 10, 2017
CAPSAICIN - QUTENZA
N 022395 001 6239180 Nov 06, 2016 DP NCE
ODE
Nov 16, 2014
Nov 16, 2016
CARBAMAZEPINE - CARBATROL
N 020712 001 5912013 Jun 15, 2016 U-277
CARBAMAZEPINE - CARBATROL
N 020712 002 5912013 Jun 15, 2016 U-277
CARBAMAZEPINE - CARBATROL
N 020712 003 5912013 Jun 15, 2016 U-277
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 30 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CARBAMAZEPINE - EQUETRO
N 021710 001 5912013
6977253
Jun 15, 2016
May 19, 2024
DP
U-693
CARBAMAZEPINE - EQUETRO
N 021710 002 5912013
6977253
Jun 15, 2016
May 19, 2024
DP
U-693
CARBAMAZEPINE - EQUETRO
N 021710 003 5912013
6977253
Jun 15, 2016
May 19, 2024
DP
U-693
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 50
N 021485 001 5446194
6500867
6797732
Oct 19, 2013
Jun 29, 2020
Jun 29, 2020
DS
DP U-219
DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 100
N 021485 002 5446194
6500867
6797732
Oct 19, 2013
Jun 29, 2020
Jun 29, 2020
DS
DP U-219
DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 150
N 021485 003 5446194
6500867
6797732
Oct 19, 2013
Jun 29, 2020
Jun 29, 2020
DS
DP U-219
DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 200
N 021485 004 5446194
6500867
6797732
Oct 19, 2013
Jun 29, 2020
Jun 29, 2020
DS
DP U-219
DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 75
N 021485 005 5446194
6500867
6797732
Oct 19, 2013
Jun 29, 2020
Jun 29, 2020
DS
DP U-219
DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 125
N 021485 006 5446194
6500867
6797732
Oct 19, 2013
Jun 29, 2020
Jun 29, 2020
DS
DP U-219
DP
CARBINOXAMINE MALEATE - KARBINAL ER
N 022556 001 8062667 Mar 29, 2029 DP
CARFILZOMIB - KYPROLIS
N 202714 001 7232818
7417042
7491704
7737112
8129346
8207125
8207126
8207127
8207297
Apr 14, 2025
Jun 07, 2026
Apr 14, 2025
Dec 07, 2027
Dec 25, 2026
Apr 14, 2025
Apr 14, 2025
Apr 14, 2025
Apr 14, 2025
DS DP
DS DP
U-1260
DP
U-1260
DS DP
DP
U-1260
DS DP
NCE
ODE
Jul 20, 2017
Jul 20, 2019
CARGLUMIC ACID - CARBAGLU
N 022562 001 NCE
ODE
Mar 18, 2015
Mar 18, 2017
CARVEDILOL - COREG
N 020297 001 RE40000 Jun 07, 2015 U-233
CARVEDILOL - COREG
N 020297 002 RE40000 Jun 07, 2015 U-233
CARVEDILOL - COREG
N 020297 003 RE40000 Jun 07, 2015 U-233
CARVEDILOL - COREG
N 020297 004 RE40000 Jun 07, 2015 U-233
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 31 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CARVEDILOL PHOSPHATE - COREG CR
N 022012 001 6022562
7268156
7268156
8101209
RE40000
Oct 17, 2015
Jun 27, 2023
Jun 27, 2023
Sep 11, 2025
Jun 07, 2015
DP
DS DP U-3
DS DP U-313
DP
U-777
Y
CARVEDILOL PHOSPHATE - COREG CR
N 022012 002 6022562
7268156
7268156
8101209
RE40000
Oct 17, 2015
Jun 27, 2023
Jun 27, 2023
Sep 11, 2025
Jun 07, 2015
DP
DS DP U-3
DS DP U-313
DP
U-777
Y
CARVEDILOL PHOSPHATE - COREG CR
N 022012 003 6022562
7268156
7268156
8101209
RE40000
Oct 17, 2015
Jun 27, 2023
Jun 27, 2023
Sep 11, 2025
Jun 07, 2015
DP
DS DP U-3
DS DP U-313
DP
U-777
Y
CARVEDILOL PHOSPHATE - COREG CR
N 022012 004 6022562
7268156
7268156
8101209
RE40000
Oct 17, 2015
Jun 27, 2023
Jun 27, 2023
Sep 11, 2025
Jun 07, 2015
DP
DS DP U-3
DS DP U-313
DP
U-777
Y
CASPOFUNGIN ACETATE - CANCIDAS
N 021227 001 5514650
5952300
6136783
Jan 26, 2015
Mar 28, 2017
Mar 28, 2017
DP U-607
DP
U-607
CASPOFUNGIN ACETATE - CANCIDAS
N 021227 002 5514650
5952300
6136783
Jan 26, 2015
Mar 28, 2017
Mar 28, 2017
DP U-607
DP
U-607
CEFDITOREN PIVOXIL - SPECTRACEF
N 021222 001 5958915 Oct 14, 2016
CEFDITOREN PIVOXIL - SPECTRACEF
N 021222 002 5958915 Oct 14, 2016 DP
CEFTAROLINE FOSAMIL - TEFLARO
N 200327 001 6417175
6906055
7419973
8247400
Dec 17, 2018
Dec 15, 2021
Dec 15, 2021
Feb 10, 2031
DS DP U-282
DS DP
DP
DP U-282
NCE Oct 29, 2015
CEFTAROLINE FOSAMIL - TEFLARO
N 200327 002 6417175
6906055
7419973
8247400
Dec 17, 2018
Dec 15, 2021
Dec 15, 2021
Feb 10, 2031
DS DP U-282
DS DP
DP
DP U-282
NCE Oct 29, 2015
CEFTIBUTEN DIHYDRATE - CEDAX
N 050686 001 5599557
5599557
Feb 04, 2014
Feb 04, 2014
DP U-282
DP U-578
CEFTIBUTEN DIHYDRATE - CEDAX
N 050686 002 5599557
5599557
Feb 04, 2014
Feb 04, 2014
DP U-282
DP U-578
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 32 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CELECOXIB - CELEBREX
N 020998 001 5466823 Nov 30, 2013 DS
5563165 Nov 30, 2013 DP
5760068 Jun 02, 2015 U-672
RE44048 Jun 02, 2015 U-247
RE44048 Jun 02, 2015 U-1348
RE44048 Jun 02, 2015 U-1349
RE44048 Jun 02, 2015 U-1350
RE44048 Jun 02, 2015 U-1351
RE44048 Jun 02, 2015 U-1352
RE44048*PED Dec 02, 2015
CELECOXIB - CELEBREX
N 020998 002 5466823 Nov 30, 2013 DS
5563165 Nov 30, 2013 DP
5760068 Jun 02, 2015 U-672
RE44048 Jun 02, 2015 U-247
RE44048 Jun 02, 2015 U-1348
RE44048 Jun 02, 2015 U-1349
RE44048 Jun 02, 2015 U-1350
RE44048 Jun 02, 2015 U-1351
RE44048 Jun 02, 2015 U-1352
RE44048*PED Dec 02, 2015
CELECOXIB - CELEBREX
N 020998 003 5466823 Nov 30, 2013 DS
5563165 Nov 30, 2013 DP
5760068 Jun 02, 2015 U-672
RE44048 Jun 02, 2015 U-247
RE44048 Jun 02, 2015 U-1348
RE44048 Jun 02, 2015 U-1349
RE44048 Jun 02, 2015 U-1350
RE44048 Jun 02, 2015 U-1351
RE44048 Jun 02, 2015 U-1352
RE44048*PED Dec 02, 2015
CELECOXIB - CELEBREX
N 020998 004 5466823 Nov 30, 2013 DS
5563165 Nov 30, 2013 DP
5760068 Jun 02, 2015 U-672
RE44048 Jun 02, 2015 U-247
RE44048 Jun 02, 2015 U-1348
RE44048 Jun 02, 2015 U-1349
RE44048 Jun 02, 2015 U-1350
RE44048 Jun 02, 2015 U-1351
RE44048 Jun 02, 2015 U-1352
RE44048*PED Dec 02, 2015
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY
N 021621 003 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY
N 021621 004 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF
N 021621 005 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF
N 021621 006 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ZYRTEC-D 12 HOUR
N 021150 002 6469009 Jul 13, 2019 DP U-295
6489329 Apr 08, 2016 DP
7014867 Jun 10, 2022 DP
7226614 Jun 10, 2022 U-295
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 33 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CETRORELIX - CETROTIDE
N 021197 001 6319192 Apr 23, 2019 U-426
6863891 Feb 22, 2014 U-426
7605121 Feb 22, 2014 DP
CETRORELIX - CETROTIDE
N 021197 002 6319192 Apr 23, 2019 U-426
6863891 Feb 22, 2014 U-426
7605121 Feb 22, 2014 DP
CEVIMELINE HYDROCHLORIDE - EVOXAC
N 020989 002 5340821 Jul 07, 2013 U-309
CHLORHEXIDINE GLUCONATE - CHLORHEXIDINE GLUCONATE
N 021669 001 7066916 Feb 17, 2024 U-737
7427574 Apr 25, 2026 DP
7595021 May 12, 2023 DP U-1022
7717889 Feb 27, 2025 DP U-1022
7935093 Oct 02, 2027 DP U-1022
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP
N 020832 001 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT
N 020832 002 5690958 Sep 30, 2016 DP
6729786 Mar 14, 2023 DP
6991394 Jan 31, 2024 DP
7182536 Dec 30, 2023 DP
7241065 Mar 14, 2023 DP
7422388 Apr 25, 2027 DP U-1397
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP FREPP
N 020832 003 5538353 Aug 25, 2015 DP
5690958 Sep 30, 2016 DP
5772346 Apr 22, 2017 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP
N 020832 004 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT
N 020832 005 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
6729786 Mar 14, 2023 DP
7241065 Mar 14, 2023 DP
7422388 Apr 25, 2027 DP U-1397
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP
N 020832 006 5690958 Sep 30, 2016 DP
6991394 Jan 31, 2024 DP
7182536 Dec 30, 2023 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT
N 020832 007 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
6729786 Mar 14, 2023 DP
7241065 Mar 14, 2023 DP
7422388 Apr 25, 2027 DP U-1397
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - PREVANTICS MAXI SWABSTICK
N 021524 003 D468424 Jan 07, 2017
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP SEPP
N 021555 001 5690958 Sep 30, 2016 DP
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - ADVIL ALLERGY SINUS
N 021441 001 7863287 Feb 28, 2027 DP
CHOLINE C-11 - CHOLINE C-11
N 203155 001 NCE Sep 12, 2017
W Sep 12, 2017
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 34 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CHOLINE FENOFIBRATE - TRILIPIX
N 022224 001 7259186 Jan 07, 2025 DS
CHOLINE FENOFIBRATE - TRILIPIX
N 022224 002 7259186 Jan 07, 2025 DS
CHORIOGONADOTROPIN ALFA - OVIDREL
N 021149 001 5767251 Jun 16, 2015
CHORIOGONADOTROPIN ALFA - OVIDREL
N 021149 002 5767251
6706681
Jun 16, 2015
Mar 16, 2021
DS
DP
CICLESONIDE - ALVESCO
N 021658 002 5482934
5605674
5683677
5775321
6006745
6120752
6264923
8371292
CICLESONIDE - ALVESCO
Oct 24, 2017
Feb 25, 2014
Nov 04, 2014
Jul 07, 2015
Dec 28, 2016
May 13, 2018
May 13, 2018
Aug 25, 2027
DS DP U-1002
DP
DP
DP
DP
DP
DP
U-1355
M-125 Dec 17, 2015
N 021658 003 5482934
5605674
5683677
5775321
6006745
6120752
6264923
8371292
Oct 24, 2017
Feb 25, 2014
Nov 04, 2014
Jul 07, 2015
Dec 28, 2016
May 13, 2018
May 13, 2018
Aug 25, 2027
DS DP U-1002
DP
DP
DP
DP
DP
DP
U-1355
M-125 Dec 17, 2015
CICLESONIDE - OMNARIS
N 022004 001 5482934
6767901
6939559
7235247
8371292
8383611
Oct 24, 2017
Oct 21, 2020
Apr 21, 2019
Apr 21, 2019
Aug 25, 2027
Oct 20, 2020
DS DP U-557
DP
DP
DP
U-1356
DP
CICLESONIDE - ZETONNA
N 202129 001 5482934
5605674
5683677
5775321
6006745
6120752
6264923
8371292
Oct 24, 2017
Feb 25, 2014
Nov 04, 2014
Jul 07, 2015
Dec 28, 2016
May 13, 2018
May 13, 2018
Aug 25, 2027
DS DP U-1002
DP
DP
DP
DP
DP
DP
U-1357
NP Jan 20, 2015
CICLOPIROX - LOPROX
N 020519 001 7018656
7026337
Sep 05, 2018
Nov 21, 2016
DP
U-714
CICLOPIROX - LOPROX
N 021159 001 7981909
8227490
Sep 16, 2017
Sep 16, 2017
U-1162
U-1256
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 35 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
APPL/PROD
NO PATENT NO
CINACALCET HYDROCHLORIDE - SENSIPAR
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021688 001 6011068 Mar 08, 2018
6031003 Dec 14, 2016
6211244 Oct 23, 2015
6313146 Dec 14, 2016
7829595 Sep 22, 2026
CINACALCET HYDROCHLORIDE - SENSIPAR
DS DP
U-559
DS DP U-560
DS DP
DP U-1098
I-634
M-101
ODE
Feb 25, 2014
Feb 25, 2014
Feb 25, 2018
N 021688 002 6011068 Mar 08, 2018
6031003 Dec 14, 2016
6211244 Oct 23, 2015
6313146 Dec 14, 2016
7829595 Sep 22, 2026
CINACALCET HYDROCHLORIDE - SENSIPAR
DS DP
DS DP U-560
DS DP
DP U-1098
I-634
M-101
ODE
Feb 25, 2014
Feb 25, 2014
Feb 25, 2018
N 021688 003 6011068
6031003
6211244
6313146
7829595
Mar 08, 2018
Dec 14, 2016
Oct 23, 2015
Dec 14, 2016
Sep 22, 2026
DS DP
U-559
DS DP U-560
DS DP
DP U-1098
I-634
M-101
ODE
Feb 25, 2014
Feb 25, 2014
Feb 25, 2018
CIPROFLOXACIN - CIPRO
N 020780 001 5695784 Dec 09, 2014
CIPROFLOXACIN - CIPRO
N 020780 002 5695784 Dec 09, 2014
CIPROFLOXACIN HYDROCHLORIDE - PROQUIN XR
N 021744 001 5972389 Sep 19, 2016
6340475 Sep 19, 2016
6488962 Jun 20, 2020
6635280 Sep 19, 2016
DP U-663
DP U-663
DP
DP U-663
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE - CIPRO HC
N 020805 001 5843930 Jun 06, 2015 U-646
5965549 Jun 06, 2015 DP
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR
N 021473 001 7709022 Jun 23, 2021 DP
8187632 Jun 23, 2021 DP
8187632*PED Dec 23, 2021
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR
N 021473 002 7709022 Jun 23, 2021 DP
8187632 Jun 23, 2021 DP
8187632*PED Dec 23, 2021
CIPROFLOXACIN; DEXAMETHASONE - CIPRODEX
N 021537 001 6284804 Aug 10, 2020
6359016 Aug 10, 2020
CISAPRIDE MONOHYDRATE - PROPULSID QUICKSOLV
N 020767 001 5648093 Jul 15, 2014
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE - PREPOPIK
N 202535 001 8450338 Oct 10, 2028 DP
8481083 Oct 10, 2028 DP
NP Jul 16, 2015
CLARITHROMYCIN - BIAXIN XL
N 050775 001 6010718
6551616
Apr 11, 2017
Jul 15, 2017
DP U-924
U-924
CLEVIDIPINE - CLEVIPREX
N 022156 001 5739152
5856346
Apr 14, 2015
Jan 05, 2021
DP U-893
DS DP U-893
NCE Aug 01, 2013
CLEVIDIPINE - CLEVIPREX
N 022156 002 5739152
5856346
Apr 14, 2015
Jan 05, 2021
DP U-893
DS DP U-893
NCE Aug 01, 2013
CLINDAMYCIN PHOSPHATE - CLEOCIN
N 050767 001 6495157 Jul 20, 2020 DP
CLINDAMYCIN PHOSPHATE - CLINDAGEL
N 050782 001 6387383 Aug 03, 2020 DP U-818
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 36 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CLINDAMYCIN PHOSPHATE - CLINDESSE
N 050793 001 5993856
6899890
Nov 17, 2017
Apr 27, 2023
DP U-137
DP U-137
CLINDAMYCIN PHOSPHATE - EVOCLIN
N 050801 001 7141237
7374747
Jan 23, 2024
Aug 09, 2026
DS DP
DS DP U-921
CLINDAMYCIN PHOSPHATE; TRETINOIN - ZIANA
N 050802 001 6387383
RE41134
Aug 03, 2020
Feb 24, 2015
DP U-916
DP U-1033
CLINDAMYCIN PHOSPHATE; TRETINOIN - VELTIN
N 050803 001 5690923 Nov 25, 2014 DP
CLOBAZAM - ONFI
N 202067 001 NCE
ODE
Oct 21, 2016
Oct 21, 2018
CLOBAZAM - ONFI
N 202067 002 NCE
ODE
Oct 21, 2016
Oct 21, 2018
CLOBAZAM - ONFI
N 202067 003 NCE
ODE
Oct 21, 2016
Oct 21, 2018
CLOBAZAM - ONFI
N 203993 001 NCE
ODE
Oct 21, 2016
Oct 21, 2018
CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE
A 201402 001 PC Jul 31, 2013
CLOBETASOL PROPIONATE - OLUX
N 021142 001 6126920 Mar 01, 2016 U-484
CLOBETASOL PROPIONATE - CLOBEX
N 021535 001 6106848 Sep 22, 2017
CLOBETASOL PROPIONATE - CLOBEX
N 021644 001 7316810
7700081
8066975
8066976
Jun 17, 2019
Jan 03, 2022
Jun 17, 2019
Jun 17, 2019
DP
U-1044
DP
DP
CLOBETASOL PROPIONATE - CLOBEX
N 021835 001 5972920
5990100
Feb 12, 2018
Mar 24, 2018
DP
DP U-742
CLOBETASOL PROPIONATE - OLUX E
N 022013 001 6730288
7029659
8460641
Sep 08, 2019
Sep 08, 2019
Nov 05, 2028
DP
DP
DP U-1410
CLOFARABINE - CLOLAR
N 021673 001 5661136 Jan 14, 2018 U-626
CLONIDINE HYDROCHLORIDE - JENLOGA
N 022331 001 5869100 Oct 13, 2013 DP
CLONIDINE HYDROCHLORIDE - JENLOGA
N 022331 002 5869100 Oct 13, 2013 DP
CLONIDINE HYDROCHLORIDE - KAPVAY
N 022331 003 5869100 Oct 13, 2013 DP NP Sep 28, 2013
CLONIDINE HYDROCHLORIDE - KAPVAY
N 022331 004 5869100 Oct 13, 2013 DP NP Sep 28, 2013
CLOPIDOGREL BISULFATE - PLAVIX
N 020839 001 6429210
6504030
Jun 10, 2019
Jun 10, 2019
DS DP
DS
M-61
PED
May 06, 2014
Nov 06, 2014
CLOPIDOGREL BISULFATE - PLAVIX
N 020839 002 6429210
6504030
Jun 10, 2019
Jun 10, 2019
DS DP
DS
M-61
PED
May 06, 2014
Nov 06, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 37 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CLOZAPINE - FAZACLO ODT
N 021590 001 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N 021590 002 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N 021590 003 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N 021590 004 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N 021590 005 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N 021590 006 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - STRIBILD
N 203100 001 5814639 Sep 29, 2015 DS DP
5914331 Jul 02, 2017 DS
5922695 Jul 25, 2017 DS U-257
5935946 Jul 25, 2017 DS DP U-257
5977089 Jul 25, 2017 DS DP U-257
6043230 Jul 25, 2017 U-257
6642245 Nov 04, 2020 U-257
6703396 Mar 09, 2021 DS DP
7176220 Nov 20, 2023 DS DP U-257
7635704 Oct 26, 2026 DS DP U-257
8148374 Sep 03, 2029 DS DP U-1279
8592397 Jan 13, 2024 DP U-257
COLCHICINE - COLCRYS
N 022352 001 7601758 Feb 10, 2029 U-1007 ODE Jul 29, 2016
7619004 Dec 03, 2028 U-1020
7820681 Feb 17, 2029 U-1020
7906519 Feb 17, 2029 U-1116
7915269 Feb 17, 2029 U-1007
7935731 Dec 03, 2028 U-1116
7964647 Oct 06, 2028 U-1007
7964648 Oct 06, 2028 U-1161
7981938 Oct 06, 2028 U-1166
8093296 Oct 06, 2028 U-1007
8093297 Oct 06, 2028 U-1161
8093298 Oct 06, 2028 U-1116
8097655 Oct 06, 2028 U-1020
8415395 Oct 06, 2028 U-1007
8415396 Oct 06, 2028 U-1007
8440721 Feb 17, 2029 U-1007
8440722 Feb 17, 2029 U-1020
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 38 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
COLESEVELAM HYDROCHLORIDE - WELCHOL
N 021141 001 5607669
5679717
5693675
5917007
5919832
6066678
6433026
Jun 10, 2014
Apr 29, 2014
Dec 02, 2014
Apr 29, 2014
Jun 10, 2014
Jun 10, 2014
Jun 10, 2014
U-323
U-323
U-323
U-323
COLESEVELAM HYDROCHLORIDE - WELCHOL
N 021176 001 5607669 Jun 10, 2014
5679717 Apr 29, 2014
5693675 Dec 02, 2014
5917007 Apr 29, 2014
5919832 Apr 29, 2014
6066678 Apr 29, 2014
6433026 Apr 29, 2014
6784254 Apr 29, 2014
7101960 Apr 29, 2014
7229613 Apr 17, 2022
COLESEVELAM HYDROCHLORIDE - WELCHOL
U-323
U-323
DS
DS U-323
DS
DS U-323
DS
DS DP
DS DP U-757
U-851
N 022362 001 5607669 Jun 10, 2014
5679717 Apr 29, 2014
5693675 Dec 02, 2014
5917007 Apr 29, 2014
5919832 Apr 29, 2014
6066678 Apr 29, 2014
6433026 Apr 29, 2014
6784254 Apr 29, 2014
7101960 Apr 29, 2014
7229613 Apr 17, 2022
COLESEVELAM HYDROCHLORIDE - WELCHOL
U-757
U-757
DS
DS U-757
DS
DS U-757
DS
DS DP
DS DP U-757
U-493
N 022362 002 5607669
5679717
5693675
5917007
5919832
6066678
6433026
6784254
7101960
7229613
Jun 10, 2014
Apr 29, 2014
Dec 02, 2014
Apr 29, 2014
Apr 29, 2014
Apr 29, 2014
Apr 29, 2014
Apr 29, 2014
Apr 29, 2014
Apr 17, 2022
U-757
U-757
DS
DS U-757
DS
DS U-757
DS
DS DP
DS DP U-757
U-493
CONIVAPTAN HYDROCHLORIDE - VAPRISOL
N 021697 001 5723606
5723606
Dec 15, 2019
Dec 15, 2019
DS DP U-698
DS DP U-868
CONIVAPTAN HYDROCHLORIDE - VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER
N 021697 002 5723606
5723606
Dec 15, 2019
Dec 15, 2019
DS DP U-698
DS DP U-868
CORTICOTROPIN - H.P. ACTHAR GEL
N 008372 008 ODE Oct 15, 2017
CRIZOTINIB - XALKORI
N 202570 001 7230098
7825137
7858643
8217057
Mar 01, 2025
May 12, 2027
Oct 08, 2029
Nov 06, 2029
DS
U-1179
DS DP
DS DP
NCE
ODE
Aug 26, 2016
Aug 26, 2018
CRIZOTINIB - XALKORI
N 202570 002 7230098
7825137
7858643
8217057
Mar 01, 2025
May 12, 2027
Oct 08, 2029
Nov 06, 2029
DS
U-1179
DS DP
DS DP
NCE
ODE
Aug 26, 2016
Aug 26, 2018
CROFELEMER - FULYZAQ
N 202292 001 7323195
7341744
8574634
Jun 07, 2018
Jun 16, 2018
Jan 11, 2018
DP
U-1319
U-1319
NCE Dec 31, 2017
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 39 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CYANOCOBALAMIN - NASCOBAL
N 021642 001 7229636
7404489
7879349
Jun 11, 2024
Mar 12, 2024
Jun 01, 2024
DP U-817
DP
DP U-1152
CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX
N 021777 001 7387793
7544372
7790199
7820203
7829121
Feb 26, 2025
Nov 14, 2023
Nov 14, 2023
Nov 14, 2023
Nov 14, 2023
DP
U-979
DP
DP
U-1088
CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX
N 021777 002 7387793
7544372
7790199
7820203
7829121
Feb 26, 2025
Nov 14, 2023
Nov 14, 2023
Nov 14, 2023
Nov 14, 2023
DP
U-979
DP
DP
U-1088
CYCLOSPORINE - NEORAL
N 050715 001 5985321
CYCLOSPORINE - NEORAL
Sep 26, 2014 DP
N 050715 002 5985321
CYCLOSPORINE - NEORAL
Sep 26, 2014 DP
N 050715 003 5985321
CYCLOSPORINE - NEORAL
Sep 26, 2014 DP
N 050716 001 5985321
CYCLOSPORINE - RESTASIS
Sep 26, 2014 DP
N 050790 001 5474979 May 17, 2014
8629111 Aug 27, 2024
CYSTEAMINE BITARTRATE - PROCYSBI
DP
DP
N 203389 001 8026284
8129433
Sep 22, 2027
Jan 26, 2027
U-1399
DP
NDF Apr 30, 2016
CYSTEAMINE BITARTRATE - PROCYSBI
N 203389 002 8026284
8129433
Sep 22, 2027
Jan 26, 2027
U-1399
DP
NDF Apr 30, 2016
CYSTEAMINE HYDROCHLORIDE - CYSTARAN
N 200740 001 NP
ODE
Oct 02, 2015
Oct 02, 2019
CYTARABINE - DEPOCYT
N 021041 001 5723147 Mar 03, 2015 DP U-806
DABIGATRAN ETEXILATE MESYLATE - PRADAXA
N 022512 001 6087380 Feb 18, 2018
7866474 Aug 31, 2027
7932273 Sep 07, 2025
DABIGATRAN ETEXILATE MESYLATE - PRADAXA
DS DP U-1089
DP
DS DP
NCE Oct 19, 2015
N 022512 002 6087380
7866474
7932273
DABRAFENIB MESYLATE - TAFINLAR
Feb 18, 2018
Aug 31, 2027
Sep 07, 2025
DS DP U-1089
DP
DS DP
NCE Oct 19, 2015
N 202806 001 7994185
8415345
DABRAFENIB MESYLATE - TAFINLAR
Jan 20, 2030
Jan 20, 2030
DS DP U-1406
DS DP U-1406
NCE
ODE
May 29, 2018
May 29, 2020
N 202806 002 7994185
8415345
DALFAMPRIDINE - AMPYRA
Jan 20, 2030
Jan 20, 2030
DS DP U-1406
DS DP U-1406
NCE
ODE
May 29, 2018
May 29, 2020
N 022250 001 5540938
8007826
8354437
8440703
Jul 30, 2018
May 26, 2027
Dec 22, 2026
Apr 08, 2025
U-1030
U-1030
U-1030
U-1030
NCE
ODE
Jan 22, 2015
Jan 22, 2017
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 40 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
NO PATENT NO EXPIRATION
DATE
DAPSONE - ACZONE
N 021794 001 5863560 Sep 11, 2016
6060085 Sep 11, 2016
6620435 Sep 11, 2016
DAPTOMYCIN - CUBICIN
N 021572 001 6468967 Sep 24, 2019
6852689 Sep 24, 2019
8058238 Nov 28, 2020
DAPTOMYCIN - CUBICIN
N 021572 002 6468967 Sep 24, 2019
6852689 Sep 24, 2019
8003673 Sep 04, 2028
8058238 Nov 28, 2020
8129342 Nov 28, 2020
RE39071 Jun 15, 2016
DARIFENACIN HYDROBROMIDE - ENABLEX
N 021513 001 5096890 Mar 13, 2015
6106864 Aug 21, 2016
DARIFENACIN HYDROBROMIDE - ENABLEX
N 021513 002 5096890 Mar 13, 2015
6106864 Aug 21, 2016
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DP
U-124
DP
U-282
U-282
DS DP
U-282
U-282
U-1180
DS DP
DS DP
DS DP U-728
DS DP U-631
DP U-630
DS DP U-631
DP U-630
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 41 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
DARUNAVIR ETHANOLATE - PREZISTA
N 021976 001 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6248775
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED
8597876
RE42889
RE43596
RE43802
DARUNAVIR ETHANOLATE - PREZISTA
N 021976 002 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6248775
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED
8597876
RE42889
RE43596
RE43802
PATENT
EXPIRATION
DATE
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Aug 13, 2014
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Jun 23, 2019
Jun 23, 2019
Jun 23, 2019
Dec 26, 2026
Feb 16, 2024
Aug 16, 2024
Jun 23, 2019
Oct 19, 2016
May 09, 2017
Oct 19, 2016
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Aug 13, 2014
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Jun 23, 2019
Jun 23, 2019
Jun 23, 2019
Dec 26, 2026
Feb 16, 2024
Aug 16, 2024
Jun 23, 2019
Oct 19, 2016
May 09, 2017
Oct 19, 2016
PATENT
PATENT DELIST
CODES REQUESTED
DP U-744
DP U-903
DP U-935
DP U-1209
DP U-1305
U-935
U-1209
U-1305
DS
U-935
U-1209
U-1305
U-935
U-1209
U-1305
DS DP
DS DP
U-1305
DP
DS DP
U-1305
DP U-744
DP U-903
DP U-935
DP U-1209
DP U-1305
U-935
U-1209
U-1305
DS
U-935
U-1209
U-1305
U-935
U-1209
U-1305
DS DP
DS DP
DP
DS DP
U-1305
EXCLUSIVITY
EXCLUSIVITY EXPIRATION
CODE(S) DATE
D-129 Dec 13, 2013
D-135 Feb 01, 2016
NPP Dec 16, 2014
PED Aug 01, 2016
PED Jun 16, 2015
PED Jun 13, 2014
D-129 Dec 13, 2013
D-135 Feb 01, 2016
NPP Dec 16, 2014
PED Jun 16, 2015
PED Jun 13, 2014
PED Aug 01, 2016
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 42 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
DARUNAVIR ETHANOLATE - PREZISTA
N 021976 003 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6248775
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED
8597876
RE42889
RE43596
RE43802
DARUNAVIR ETHANOLATE - PREZISTA
N 021976 004 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6248775
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED
8597876
RE42889
RE43596
RE43802
PATENT
EXPIRATION
DATE
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Aug 13, 2014
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Jun 23, 2019
Jun 23, 2019
Jun 23, 2019
Dec 26, 2026
Feb 16, 2024
Aug 16, 2024
Jun 23, 2019
Oct 19, 2016
May 09, 2017
Oct 19, 2016
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Aug 13, 2014
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Jun 23, 2019
Jun 23, 2019
Jun 23, 2019
Dec 26, 2026
Feb 16, 2024
Aug 16, 2024
Jun 23, 2019
Oct 19, 2016
May 09, 2017
Oct 19, 2016
PATENT
PATENT DELIST
CODES REQUESTED
DP U-744
DP U-903
DP U-935
DP U-1209
DP U-1305
U-935
U-1209
U-1305
DS
U-935
U-1209
U-1305
U-935
U-1209
U-1305
DS DP
DS DP
DP
DS DP
U-1305
DP U-744
DP U-903
DP U-935
DP U-1209
DP U-1305
U-935
U-1209
U-1305
DS
U-935
U-1209
U-1305
U-935
U-1209
U-1305
DS DP
DS DP
DP
DS DP
U-1305
EXCLUSIVITY
EXCLUSIVITY EXPIRATION
CODE(S) DATE
D-129 Dec 13, 2013
D-135 Feb 01, 2016
NPP Dec 16, 2014
PED Jun 13, 2014
PED Jun 16, 2015
PED Aug 01, 2016
D-129 Dec 13, 2013
D-135 Feb 01, 2016
NPP Dec 16, 2014
PED Jun 16, 2015
PED Jun 13, 2014
PED Aug 01, 2016
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 43 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
DARUNAVIR ETHANOLATE - PREZISTA
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021976 005 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6248775
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED
8597876
RE42889
RE43596
RE43802
DARUNAVIR ETHANOLATE - PREZISTA
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Aug 13, 2014
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Jun 23, 2019
Jun 23, 2019
Jun 23, 2019
Dec 26, 2026
Feb 16, 2024
Aug 16, 2024
Jun 23, 2019
Oct 19, 2016
May 09, 2017
Oct 19, 2016
DP U-744
DP U-903
DP U-935
DP U-1209
DP U-1305
U-935
U-1209
U-1305
DS
U-935
U-1209
U-1305
U-935
U-1209
U-1305
DS DP
DS DP
DP
DS DP
U-1305
D-129
D-135
NPP
PED
PED
PED
Dec 13, 2013
Feb 01, 2016
Dec 16, 2014
Jun 16, 2015
Aug 01, 2016
Jun 13, 2014
N 021976 006 5843946
5843946
5843946
5843946
5843946
6037157
6037157
6037157
6248775
6703403
6703403
6703403
7470506
7470506
7470506
7700645
8518987
8518987*PED
8597876
RE42889
RE43596
RE43802
DARUNAVIR ETHANOLATE - PREZISTA
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Dec 01, 2015
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Aug 13, 2014
Jun 26, 2016
Jun 26, 2016
Jun 26, 2016
Jun 23, 2019
Jun 23, 2019
Jun 23, 2019
Dec 26, 2026
Feb 16, 2024
Aug 16, 2024
Jun 23, 2019
Oct 19, 2016
May 09, 2017
Oct 19, 2016
DP U-744
DP U-903
DP U-935
DP U-1209
DP U-1305
U-935
U-1209
U-1305
DS
U-935
U-1209
U-1305
U-935
U-1209
U-1305
DS DP
DS DP
DP
DS DP
U-1305
D-129
D-135
NPP
PED
PED
PED
Dec 13, 2013
Feb 01, 2016
Dec 16, 2014
Jun 16, 2015
Jun 13, 2014
Aug 01, 2016
N 202895 001 5843946
5843946
6037157
6037157
6248775
6703403
6703403
7470506
7470506
7700645
8518987
8518987*PED
8597876
RE42889
RE43596
RE43802
Dec 01, 2015
Dec 01, 2015
Jun 26, 2016
Jun 26, 2016
Aug 13, 2014
Jun 26, 2016
Jun 26, 2016
Jun 23, 2019
Jun 23, 2019
Dec 26, 2026
Feb 16, 2024
Aug 16, 2024
Jun 23, 2019
Oct 19, 2016
May 09, 2017
Oct 19, 2016
DP U-1209
DP U-1305
U-1209
U-1305
DS
U-1209
U-1305
U-1209
U-1305
DS DP
DS DP
U-1305
DP
DS DP
U-1305
D-135
NDF
PED
PED
Feb 01, 2016
Dec 16, 2014
Jun 16, 2015
Aug 01, 2016
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 44 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
DASATINIB - SPRYCEL
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021986 001 6596746
6596746
7125875
7125875
7153856
7491725
Jun 28, 2020
Jun 28, 2020
Apr 13, 2020
Apr 13, 2020
Apr 28, 2020
Mar 28, 2026
DS DP U-748
DS DP U-780
U-779
U-780
U-780
DS DP
M-94 Oct 28, 2013
DASATINIB - SPRYCEL
N 021986 002 6596746
6596746
7125875
7125875
7153856
7491725
Jun 28, 2020
Jun 28, 2020
Apr 13, 2020
Apr 13, 2020
Apr 28, 2020
Mar 28, 2026
DS DP U-748
DS DP U-780
U-779
U-780
U-780
DS DP
M-94 Oct 28, 2013
DASATINIB - SPRYCEL
N 021986 003 6596746
6596746
7125875
7125875
7153856
7491725
Jun 28, 2020
Jun 28, 2020
Apr 13, 2020
Apr 13, 2020
Apr 28, 2020
Mar 28, 2026
DS DP U-748
DS DP U-780
U-779
U-780
U-780
DS DP
M-94 Oct 28, 2013
DASATINIB - SPRYCEL
N 021986 004 6596746
6596746
7125875
7125875
7153856
7491725
Jun 28, 2020
Jun 28, 2020
Apr 13, 2020
Apr 13, 2020
Apr 28, 2020
Mar 28, 2026
DS DP U-748
DS DP U-780
U-779
U-780
U-780
DS DP
M-94 Oct 28, 2013
DASATINIB - SPRYCEL
N 021986 005 6596746
6596746
7125875
7125875
7153856
7491725
Jun 28, 2020
Jun 28, 2020
Apr 13, 2020
Apr 13, 2020
Apr 28, 2020
Mar 28, 2026
DS DP U-748
DS DP U-780
U-779
U-780
U-780
DS DP
M-94 Oct 28, 2013
DASATINIB - SPRYCEL
N 021986 006 6596746
6596746
7125875
7125875
7153856
7491725
Jun 28, 2020
Jun 28, 2020
Apr 13, 2020
Apr 13, 2020
Apr 28, 2020
Mar 28, 2026
DS DP U-748
DS DP U-780
U-779
U-780
U-780
DS DP
M-94 Oct 28, 2013
DEFERASIROX - EXJADE
N 021882 001 6465504
6596750
Apr 05, 2019
Jun 24, 2017
DS DP
DS U-735
I-665 Jan 23, 2016
DEFERASIROX - EXJADE
N 021882 002 6465504
6596750
Apr 05, 2019
Jun 24, 2017
DS DP
DS U-735
I-665 Jan 23, 2016
DEFERASIROX - EXJADE
N 021882 003 6465504
6596750
Apr 05, 2019
Jun 24, 2017
DS DP
DS U-735
I-665 Jan 23, 2016
DEFERIPRONE - FERRIPROX
N 021825 001 NCE
ODE
Oct 14, 2016
Oct 14, 2018
DEGARELIX ACETATE - FIRMAGON
N 022201 001 5925730
DEGARELIX ACETATE - FIRMAGON
May 18, 2021 DS DP U-943 NCE Dec 24, 2013
N 022201 002 5925730 May 18, 2021 DS DP U-943 NCE Dec 24, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 45 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DELAVIRDINE MESYLATE - RESCRIPTOR
N 020705 001 5563142 Oct 08, 2013
DELAVIRDINE MESYLATE - RESCRIPTOR
N 020705 002 5563142 Oct 08, 2013
6177101 Jun 07, 2019
DESFLURANE - SUPRANE
N 020118 001 5617906 Apr 08, 2014 DP
DESIRUDIN RECOMBINANT - IPRIVASK
N 021271 001 5733874 Mar 31, 2015
DESLORATADINE - CLARINEX
N 021165 001 6100274 Jul 07, 2019
7211582 Dec 30, 2014 U-809
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
7405223 Jul 07, 2019 U-886
DESLORATADINE - CLARINEX
N 021300 001 6514520 Jun 01, 2018 DP
7211582 Dec 30, 2014 U-809
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
DESLORATADINE - CLARINEX
N 021312 001 5607697 Jun 07, 2015 DP
6100274 Jul 07, 2019 DP
7211582 Dec 30, 2014 U-809
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
7618649 Dec 19, 2020 DP U-1017
DESLORATADINE - CLARINEX
N 021312 002 5607697 Jun 07, 2015 DP
6100274 Jul 07, 2019 DP
7211582 Dec 30, 2014 U-809
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
7618649 Dec 19, 2020 DP U-1017
DESLORATADINE; PSEUDOEPHEDRINE SULFATE - CLARINEX-D 12 HOUR
N 021313 001 6100274 Jul 07, 2019 DP
6709676 Feb 18, 2021 DP U-707
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
7618649 Dec 19, 2020 DP U-1017
8187630 Dec 19, 2020 DP U-1017
DESLORATADINE; PSEUDOEPHEDRINE SULFATE - CLARINEX D 24 HOUR
N 021605 001 6100274 Jul 07, 2019 DP
6979463 Mar 28, 2022 DP
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
7618649 Dec 19, 2020 DP U-1017
7820199 Mar 28, 2022 DP
DESMOPRESSIN ACETATE - DDAVP
N 017922 001 5674850 Dec 23, 2013
DESMOPRESSIN ACETATE - DDAVP
N 017922 002 5674850 Dec 23, 2013
DESMOPRESSIN ACETATE - DDAVP (NEEDS NO REFRIGERATION)
N 017922 003 5674850 Dec 23, 2013
DESMOPRESSIN ACETATE - DDAVP
N 019955 001 5674850 Dec 23, 2013
7022340 Apr 30, 2023 DP
DESMOPRESSIN ACETATE - DDAVP
N 019955 002 5674850 Dec 23, 2013
7022340 Apr 30, 2023 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 46 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE
N 021795 001 7022340 Apr 30, 2023
DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE
DP
N 021795 002 7022340 Apr 30, 2023 DP
DESONIDE - DESONATE
N 021844 001 6387383 Aug 03, 2020 DS DP U-783
DESONIDE - VERDESO
N 021978 001 6730288
7029659
8460641
Sep 08, 2019
Sep 08, 2019
Nov 05, 2028
DP
DP
DP U-1412
DESOXIMETASONE - TOPICORT
N 204141 001 5990100
8277780
Mar 24, 2018
Apr 23, 2028
DP U-1408
DP U-1408
NDF Apr 11, 2016
DESVENLAFAXINE SUCCINATE - PRISTIQ
N 021992 001 6673838
6673838
8269040
Feb 11, 2022
Feb 11, 2022
Jul 05, 2027
DS DP U-860
DS DP U-1364
DS
I-675 Feb 14, 2016
DESVENLAFAXINE SUCCINATE - PRISTIQ
N 021992 002 6673838
6673838
8269040
Feb 11, 2022
Feb 11, 2022
Jul 05, 2027
DS DP U-860
DS DP U-1364
DS
I-675 Feb 14, 2016
DEXAMETHASONE - OZURDEX
N 022315 001 6726918
6726918
6899717
7033605
7767223
8034366
8034366
8034370
8043628
8063031
8088407
8506987
Oct 20, 2020
Oct 20, 2020
Nov 01, 2023
Oct 20, 2020
Nov 28, 2021
Jan 09, 2023
Jan 09, 2023
Jan 09, 2023
Oct 20, 2020
Oct 20, 2020
Oct 20, 2020
Jan 09, 2023
DP U-1204
DP U-1205
U-1206
DP
DP
DP U-1204
DP U-1205
DP
DP U-1205
DP
DP U-1205
U-1204
ODE Sep 24, 2017
DEXAMETHASONE; TOBRAMYCIN - TOBRADEX ST
N 050818 001 7795316
8101582
Aug 03, 2028
Dec 19, 2027
DP U-1082
DP U-1082
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 47 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DEXLANSOPRAZOLE - DEXILANT
N 022287 001 6462058 Jun 15, 2020 DS DP U-949
6462058 Jun 15, 2020 DS DP U-950
6462058 Jun 15, 2020 DS DP U-951
6664276 Jun 15, 2020 DS DP U-949
6664276 Jun 15, 2020 DS DP U-950
6664276 Jun 15, 2020 DS DP U-951
6939971 Jun 15, 2020 U-949
6939971 Jun 15, 2020 U-950
6939971 Jun 15, 2020 U-951
7285668 Jun 15, 2020 DS
7790755 Aug 02, 2026 DP
8105626 Sep 27, 2026 DP
8173158 Mar 17, 2030 U-949
8173158 Mar 17, 2030 U-950
8173158 Mar 17, 2030 U-951
8461187 Jan 17, 2026 DP
8461187*PED Jul 17, 2026
DEXLANSOPRAZOLE - DEXILANT
N 022287 002 6462058 Jun 15, 2020 DS DP U-949
6462058 Jun 15, 2020 DS DP U-950
6462058 Jun 15, 2020 DS DP U-951
6664276 Jun 15, 2020 DS DP U-949
6664276 Jun 15, 2020 DS DP U-950
6664276 Jun 15, 2020 DS DP U-951
6939971 Jun 15, 2020 U-949
6939971 Jun 15, 2020 U-950
6939971 Jun 15, 2020 U-951
7285668 Jun 15, 2020 DS
7790755 Aug 02, 2026 DP
8105626 Sep 27, 2026 DP
8173158 Mar 17, 2030 U-949
8173158 Mar 17, 2030 U-950
8173158 Mar 17, 2030 U-951
8461187 Jan 17, 2026 DP
8461187*PED Jul 17, 2026
DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX
N 021038 001 4910214 Jul 15, 2013 DS DP U-421
4910214*PED Jan 15, 2014
6716867 Mar 31, 2019 U-1472
6716867*PED Oct 01, 2019
DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX
N 021038 002 4910214 Jul 15, 2013 DS DP U-421
4910214*PED Jan 15, 2014
6716867 Mar 31, 2019 U-1472
6716867*PED Oct 01, 2019
8242158 Jan 04, 2032 DP
8242158*PED Jul 04, 2032
8338470 Jan 04, 2032 DP
8338470*PED Jul 04, 2032
8455527 Jan 04, 2032 U-421
8455527*PED Jul 04, 2032
DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX
N 021038 003 4910214 Jul 15, 2013 DS DP U-421
4910214*PED Jan 15, 2014
6716867 Mar 31, 2019 U-1472
6716867*PED Oct 01, 2019
8242158 Jan 04, 2032 DP
8242158*PED Jul 04, 2032
8338470 Jan 04, 2032 DP
8338470*PED Jul 04, 2032
8455527 Jan 04, 2032 U-421
8455527*PED Jul 04, 2032
DEXMETHYLPHENIDATE HYDROCHLORIDE - DEXMETHYLPHENIDATE HYDROCHLORIDE
A 202580 001 PC May 17, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 48 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N 021278 001 5908850 Dec 04, 2015 U-422
6355656 Dec 04, 2015
6528530 Dec 04, 2015 DS DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N 021278 002 5908850 Dec 04, 2015 U-422
6355656 Dec 04, 2015
6528530 Dec 04, 2015 DS DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N 021278 003 5908850 Dec 04, 2015 U-422
6355656 Dec 04, 2015
6528530 Dec 04, 2015 DS DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 49 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 001 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 002 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 003 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 004 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 005 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 DP U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 006 5837284 Dec 04, 2015 DP U-677
5908850 Dec 04, 2015 DP U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 007 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 DP U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 50 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
APPL/PROD
NO PATENT NO
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021802 008 5837284
5908850
6228398
6355656
6528530
6635284
6730325
7431944
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
DP
DP U-678
DP U-676
DP
DP
DP U-677
DP U-676
DP
DEXRAZOXANE HYDROCHLORIDE - TOTECT
N 022025 001 6727253 Mar 13, 2020 U-829
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - MUCINEX DM
N 021620 001 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-685
7838032 Apr 28, 2020 DP
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - MUCINEX DM
N 021620 002 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-685
7838032 Apr 28, 2020 DP
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE - NUEDEXTA
N 021879 001 7659282 Aug 13, 2026 U-1093
8227484 Jul 17, 2023 U-1093
RE38115 Jan 26, 2016 DP
ODE
NC
Sep 06, 2014
Oct 29, 2013
DEXTROMETHORPHAN POLISTIREX - DELSYM
N 018658 001 5980882
DIAZEPAM - DIASTAT
Apr 16, 2017 DP
N 020648 001 5462740
DIAZEPAM - DIASTAT
Sep 17, 2013 DP
N 020648 002 5462740
DIAZEPAM - DIASTAT
Sep 17, 2013 DP
N 020648 003 5462740
DIAZEPAM - DIASTAT
Sep 17, 2013 DP
N 020648 004 5462740
DIAZEPAM - DIASTAT
Sep 17, 2013 DP
N 020648 005 5462740
DIAZEPAM - DIASTAT ACUDIAL
Sep 17, 2013 DP
N 020648 006 5462740
DIAZEPAM - DIASTAT ACUDIAL
Sep 17, 2013 DP
N 020648 007 5462740
DICLOFENAC - ZORVOLEX
Sep 17, 2013 DP
N 204592 001 NP Oct 18, 2016
DICLOFENAC - ZORVOLEX
N 204592 002 NP Oct 18, 2016
DICLOFENAC EPOLAMINE - FLECTOR
N 021234 001 5607690
DICLOFENAC POTASSIUM - CAMBIA
Apr 13, 2014 DP
N 022165 001 6974595
7482377
7759394
8097651
May 15, 2017
May 15, 2017
Jun 16, 2026
Jun 16, 2026
U-436
DS DP U-436
DS DP U-436
DS DP U-436
DICLOFENAC POTASSIUM - ZIPSOR
N 022202 001 6365180
7662858
7884095
7939518
8110606
Jul 15, 2019
Feb 24, 2029
Feb 24, 2029
Feb 24, 2029
Feb 24, 2029
DP U-980
U-1035
U-1111
U-980
U-980
DICLOFENAC SODIUM - DICLOFENAC SODIUM
N 020809 001 5603929
5653972
Nov 16, 2014
Nov 16, 2014
U-239
U-239
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 51 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DICLOFENAC SODIUM - PENNSAID
N 020947 001 8217078 Jul 10, 2029 U-1248
8546450 Aug 09, 2030 U-1435
8546450 Aug 09, 2030 U-1436
8618164 Jul 10, 2029 U-1477
DICLOFENAC SODIUM - SOLARAZE
N 021005 001 5639738 Jun 17, 2014 U-402
5792753 Aug 11, 2015
5852002 Jun 17, 2014 U-402
5914322 Aug 11, 2015
5929048 Jun 17, 2014 U-402
5985850 Aug 11, 2015 DP
DICLOFENAC SODIUM; MISOPROSTOL - ARTHROTEC
N 020607 001 5601843 Feb 11, 2014
DICLOFENAC SODIUM; MISOPROSTOL - ARTHROTEC
N 020607 002 5601843 Feb 11, 2014
DIENOGEST; DIENOGEST; DIENOGEST; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL
VALERATE; ESTRADIOL VALERATE - NATAZIA
N 022252 001 6133251
6133251
6133251
6884793
8071577
8153616
Oct 25, 2016
Oct 25, 2016
Oct 25, 2016
Oct 25, 2016
May 13, 2026
Jan 30, 2028
DP U-1
DP U-112
DP U-828
DP
DP U-1
U-1240
Y
Y
Y
Y
I-648 Mar 14, 2015
DIFLUPREDNATE - DUREZOL
N 022212 001 6114319
6114319*PED
May 18, 2019
Nov 18, 2019
DP I-653
M-127
ODE
PED
PED
PED
Jun 13, 2015
Mar 22, 2016
Jun 13, 2019
Dec 13, 2015
Sep 22, 2016
Dec 13, 2019
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 001 6923984
7108866
Feb 25, 2021
Dec 17, 2019
DP
DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 002 6923984
7108866
Feb 25, 2021
Dec 17, 2019
DP
DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 003 6923984
7108866
Feb 25, 2021
Dec 17, 2019
DP
DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 004 6923984
7108866
Feb 25, 2021
Dec 17, 2019
DP
DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 005 6923984
7108866
Feb 25, 2021
Dec 17, 2019
DP
DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 006 6923984
7108866
Feb 25, 2021
Dec 17, 2019
DP
DP U-107
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 52 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
DIMETHYL FUMARATE - TECFIDERA
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 204063 001 6509376
7320999
7619001
7803840
8399514
8524773
DIMETHYL FUMARATE - TECFIDERA
Oct 29, 2019
May 18, 2020
Apr 01, 2018
Apr 01, 2018
Feb 07, 2028
Apr 01, 2018
DP
U-1384
U-1384
U-1385
U-1384
U-1384
NCE Mar 27, 2018
N 204063 002 6509376 Oct 29, 2019
7320999 May 18, 2020
7619001 Apr 01, 2018
7803840 Apr 01, 2018
8399514 Feb 07, 2028
8524773 Apr 01, 2018
DIMYRISTOYL LECITHIN; PERFLEXANE - IMAGENT
N 021191 001 5605673 Feb 25, 2014
5626833 May 16, 2014
5639443 Jun 17, 2014
5695741 Dec 09, 2014
5720938 Feb 24, 2015
5798091 Aug 25, 2015
6280704 Jul 30, 2013
6280705 Jul 30, 2013
6287539 Jul 30, 2013
DP
U-1384
U-1384
U-1385
U-1384
U-1384
U-458
U-458
U-458
NCE Mar 27, 2018
DIPHENHYDRAMINE CITRATE; IBUPROFEN - ADVIL PM
N 021394 001 8263647 May 30, 2022
DIVALPROEX SODIUM - DEPAKOTE ER
DP
N 021168 001 6419953
6511678
6528090
6528091
6713086
6720004
Dec 18, 2018
Dec 18, 2018
Dec 18, 2018
Dec 18, 2018
Dec 18, 2018
Dec 18, 2018
DP
U-106
DP U-579
DP
DIVALPROEX SODIUM - DEPAKOTE ER
N 021168 002 6511678
6528090
6713086
6720004
Dec 18, 2018
Dec 18, 2018
Dec 18, 2018
Dec 18, 2018
DP
DP U-579
DP
DOCETAXEL - TAXOTERE
N 020449 001 5438072 Nov 22, 2013 DP PED Nov 13, 2013
DOCETAXEL - TAXOTERE
N 020449 003 PED Nov 13, 2013
DOCETAXEL - TAXOTERE
N 020449 004 PED Nov 13, 2013
DOCOSANOL - ABREVA
N 020941 001 4874794
5534554
Apr 28, 2014
Dec 13, 2013
U-815
DP U-815
DOFETILIDE - TIKOSYN
N 020931 001 6124363 Oct 09, 2018
DOFETILIDE - TIKOSYN
N 020931 002 6124363 Oct 09, 2018
DOFETILIDE - TIKOSYN
N 020931 003 6124363 Oct 09, 2018
DOLUTEGRAVIR SODIUM - TIVICAY
N 204790 001 8129385 Oct 05, 2027 DS DP
DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE
NCE Aug 12, 2018
A 202542 001 PC Jan 22, 2014
DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE
A 202723 001 PC Jan 22, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 53 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
APPL/PROD
NO PATENT NO
DONEPEZIL HYDROCHLORIDE - ARICEPT ODT
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021720 001 7727548
7727552
Jun 23, 2022
Mar 26, 2018
DP U-1062
DP
DONEPEZIL HYDROCHLORIDE - ARICEPT ODT
N 021720 002 7727548
7727552
Jun 23, 2022
Mar 26, 2018
DP U-1062
DP
DONEPEZIL HYDROCHLORIDE - ARICEPT
N 022568 001 8481565 Oct 04, 2026 DP NP Jul 23, 2013
DORIPENEM - DORIBAX
N 022106 001 5317016
8247402
Jun 05, 2015
Mar 30, 2021
DS DP U-282
DS DP
DORIPENEM - DORIBAX
N 022106 002 5317016
8247402
Jun 05, 2015
Mar 30, 2021
DS DP U-282
DS DP
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE - COSOPT PF
N 202667 001 NP Feb 01, 2015
DOXEPIN HYDROCHLORIDE - SILENOR
N 022036 001 5585115
5725884
5866166
5948438
6103219
6211229
6217909
7915307
8513299
DOXEPIN HYDROCHLORIDE - SILENOR
Jan 09, 2015
Jan 09, 2015
Jan 09, 2015
Jan 09, 2015
Jan 09, 2015
Feb 17, 2020
Jan 09, 2015
Aug 24, 2027
Apr 14, 2030
DP
DP
DP
DP
DP
U-620
DP
U-620
U-620
N 022036 002 5585115
5725884
5866166
5948438
6103219
6211229
6217909
7915307
8513299
Jan 09, 2015
Jan 09, 2015
Jan 09, 2015
Jan 09, 2015
Jan 09, 2015
Feb 17, 2020
Jan 09, 2015
Aug 24, 2027
Apr 14, 2030
DP
DP
DP
DP
DP
U-620
DP
U-620
U-620
DOXERCALCIFEROL - HECTOROL
N 020862 001 5602116
5602116
6903083
Feb 11, 2014
Feb 11, 2014
Jul 18, 2021
U-278
U-987
DS DP Y
DOXERCALCIFEROL - HECTOROL
N 020862 002 5602116
5602116
6903083
Feb 11, 2014
Feb 11, 2014
Jul 18, 2021
U-278
U-987
DS DP Y
DOXERCALCIFEROL - HECTOROL
N 020862 003 5602116 Feb 11, 2014 U-987
DOXERCALCIFEROL - HECTOROL
N 021027 001 5602116
6903083
7148211
DOXERCALCIFEROL - HECTOROL
Feb 11, 2014
Jul 18, 2021
Sep 14, 2023
U-321
DS DP
DP
Y
Y
N 021027 002 5602116
7148211
Feb 11, 2014
Sep 14, 2023
U-321
DP Y
DOXORUBICIN HYDROCHLORIDE - DOXIL (LIPOSOMAL)
N 050718 001
DOXORUBICIN HYDROCHLORIDE - DOXIL (LIPOSOMAL)
N 050718 002
ODE
ODE
May 17, 2014
May 17, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 54 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DOXYCYCLINE - ORACEA
N 050805 001 5789395
5919775
7211267
7232572
7749532
8206740
8394405
8394406
8470364
8603506
DOXYCYCLINE HYCLATE - DORYX
Aug 30, 2016
Aug 30, 2016
Apr 05, 2022
Apr 05, 2022
Dec 19, 2027
Dec 24, 2025
Apr 07, 2024
Apr 07, 2024
Apr 07, 2024
Apr 05, 2022
U-925
U-925
U-925
U-925
DP U-1063
DP U-925
DP U-925
DP U-925
DP U-925
U-1063
Y
Y
N 050795 001 6958161
DOXYCYCLINE HYCLATE - DORYX
Dec 15, 2022 DP U-918
N 050795 002 6958161
DOXYCYCLINE HYCLATE - DORYX
Dec 15, 2022 DP U-918
N 050795 003 6958161
DOXYCYCLINE HYCLATE - DORYX
Dec 15, 2022 DP U-918
N 050795 004 6958161
DOXYCYCLINE HYCLATE - DORYX
Dec 15, 2022 DP U-918
N 050795 005 6958161 Dec 15, 2022 DP U-918
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE - DICLEGIS
N 021876 001 6340695 Jun 21, 2021 DP U-1382
7560122 Jan 25, 2019 DP
DRONEDARONE HYDROCHLORIDE - MULTAQ
N 022425 001 5223510 Jul 26, 2016 DS DP U-992
5223510 Jul 26, 2016 DS DP U-1261
7323493 Jun 19, 2018 DP
8318800 Jun 19, 2018 DP
8410167 Apr 16, 2029 U-1387
8410167 Apr 16, 2029 U-1388
8602215 Jun 30, 2031 U-1473
DROSPIRENONE; ESTRADIOL - ANGELIQ
N 021355 001
DROSPIRENONE; ESTRADIOL - ANGELIQ
N 021355 002 6933395 Aug 11, 2017 DS
DROSPIRENONE; ETHINYL ESTRADIOL - YASMIN
N 021098 001 5569652 Oct 29, 2013 U-1
6787531 Aug 31, 2020 DP
6933395 Aug 11, 2017 DS
DROSPIRENONE; ETHINYL ESTRADIOL - YAZ
N 021676 001 5569652 Oct 29, 2013 U-1
5798338 Jul 10, 2015 DP
6787531 Aug 31, 2020 DP
6933395 Aug 11, 2017 DP
6958326 Dec 20, 2021 DP
6987101 Dec 22, 2017 U-758
7163931 Dec 20, 2021 U-1
RE37564 Jun 30, 2014 DP
RE37838 Jun 30, 2014 DP
RE38253 Jun 30, 2014 DP
RE43916 Jun 30, 2014 U-1326
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - BEYAZ
N 022532 001 5798338 Jul 10, 2015 DP
6441168 Apr 17, 2020 DS
6958326 Dec 30, 2021 DP
7163931 Mar 03, 2022 U-1
RE37564 Jun 30, 2014 DP
RE37838 Jun 30, 2014 DP
RE38253 Jun 30, 2014 DP
RE43916 Jun 30, 2014 U-1326
D-136
NS
NP
NCE
NS
NC
NP
Apr 11, 2016
Apr 11, 2016
Apr 08, 2016
Jul 01, 2014
Mar 01, 2015
Sep 24, 2013
Sep 24, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 55 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - SAFYRAL
N 022574 001 5798338 Jul 10, 2015 DP
6441168 Apr 17, 2020 DS
6958326 Dec 20, 2021 DP
7163931 Mar 03, 2022 U-1
NP Dec 16, 2013
DULOXETINE HYDROCHLORIDE - CYMBALTA
N 021427 001 5508276 Jul 18, 2014
6596756 Sep 10, 2019
DULOXETINE HYDROCHLORIDE - CYMBALTA
DP
U-882
I-632
M-61
PED
PED
Nov 04, 2013
Oct 18, 2015
Apr 18, 2016
May 04, 2014
N 021427 002 5508276 Jul 18, 2014
6596756 Sep 10, 2019
DULOXETINE HYDROCHLORIDE - CYMBALTA
DP
U-882
I-632
M-61
PED
PED
Nov 04, 2013
Oct 18, 2015
May 04, 2014
Apr 18, 2016
N 021427 004 5508276
6596756
Jul 18, 2014
Sep 10, 2019
DP
U-882
I-632
M-61
PED
PED
Nov 04, 2013
Oct 18, 2015
Apr 18, 2016
May 04, 2014
DUTASTERIDE - AVODART
N 021319 001 5565467
5846976
5998427
Nov 20, 2015
Sep 17, 2013
Sep 17, 2013
DS DP
U-476
DS DP U-477
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE - JALYN
N 022460 001 5565467 Nov 20, 2015
5846976 Sep 17, 2013
5998427 Sep 17, 2013
DS DP
U-1065
DS DP U-1066
ECONAZOLE NITRATE - ECOZA
N 205175 001 5993830 Jan 16, 2018 DP U-1449 NDF Oct 24, 2016
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 56 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
EFAVIRENZ - SUSTIVA
N 020972 001 5519021*PED
5663169
5663169*PED
6238695
6238695*PED
6555133
6555133*PED
6639071
6639071*PED
6939964
6939964*PED
EFAVIRENZ - SUSTIVA
N 020972 002 5519021*PED
5663169
5663169*PED
6238695
6238695*PED
6555133
6555133*PED
6639071
6639071*PED
6939964
6939964*PED
EFAVIRENZ - SUSTIVA
N 020972 003 5519021*PED
5663169
5663169*PED
6238695
6238695*PED
6555133
6555133*PED
6639071
6639071*PED
6939964
6939964*PED
EFAVIRENZ - SUSTIVA
N 021360 001 5519021*PED
5663169
5663169*PED
6639071
6639071*PED
6939964
6939964*PED
EFAVIRENZ - SUSTIVA
N 021360 002 5519021*PED
5663169
5663169*PED
6639071
6639071*PED
6939964
6939964*PED
PATENT PATENT EXCLUSIVITY
EXPIRATION
DATE
PATENT
CODES
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXPIRATION
DATE
Nov 21, 2013
Sep 02, 2014
Mar 02, 2015
Apr 06, 2019
Oct 06, 2019
Apr 06, 2019
Oct 06, 2019
Feb 14, 2018
Aug 14, 2018
Jan 20, 2018
Jul 20, 2018
U-257
DP
U-248
DS
DS
NPP
PED
May 02, 2016
Nov 02, 2016
Nov 21, 2013
Sep 02, 2014
Mar 02, 2015
Apr 06, 2019
Oct 06, 2019
Apr 06, 2019
Oct 06, 2019
Feb 14, 2018
Aug 14, 2018
Jan 20, 2018
Jul 20, 2018
U-257
DP
U-248
DS
DS
Nov 21, 2013
Sep 02, 2014
Mar 02, 2015
Apr 06, 2019
Oct 06, 2019
Apr 06, 2019
Oct 06, 2019
Feb 14, 2018
Aug 14, 2018
Jan 20, 2018
Jul 20, 2018
U-257
DP
U-248
DS
DS
NPP
PED
May 02, 2016
Nov 02, 2016
Nov 21, 2013
Sep 02, 2014
Mar 02, 2015
Feb 14, 2018
Aug 14, 2018
Jan 20, 2018
Jul 20, 2018
DS
DS
Nov 21, 2013
Sep 02, 2014
Mar 02, 2015
Feb 14, 2018
Aug 14, 2018
Jan 20, 2018
Jul 20, 2018
DS
DS
U-248
NPP
PED
May 02, 2016
Nov 02, 2016
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 57 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - ATRIPLA
N 021937 001 5519021*PED Nov 21, 2013
5663169 Sep 02, 2014 U-750
5663169 Sep 02, 2014 U-1170
5663169*PED Mar 02, 2015
5814639 Sep 29, 2015 DS DP
5914331 Jul 02, 2017 DS
5922695 Jul 25, 2017 DS U-750
5922695 Jul 25, 2017 DS U-1170
5935946 Jul 25, 2017 DS DP U-750
5935946 Jul 25, 2017 DS DP U-1170
5977089 Jul 25, 2017 DS DP U-750
5977089 Jul 25, 2017 DS DP U-1170
6043230 Jul 25, 2017 U-750
6043230 Jul 25, 2017 U-1170
6639071 Feb 14, 2018 DS
6639071*PED Aug 14, 2018
6642245 Nov 04, 2020 U-750
6642245 Nov 04, 2020 U-1170
6703396 Mar 09, 2021 DS DP
6939964 Jan 20, 2018 DS
6939964*PED Jul 20, 2018
8592397 Jan 13, 2024 DP U-750
8592397 Jan 13, 2024 DP U-1170
8598185 May 01, 2028 DP
EFLORNITHINE HYDROCHLORIDE - VANIQA
N 021145 001 5648394 Jul 15, 2014 U-334
ELETRIPTAN HYDROBROMIDE - RELPAX
N 021016 001 5545644 Dec 26, 2016 DS DP U-876
6110940 Aug 29, 2017
ELETRIPTAN HYDROBROMIDE - RELPAX
N 021016 002 5545644 Dec 26, 2016 DS DP U-876
6110940 Aug 29, 2017
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 58 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
ELTROMBOPAG OLAMINE - PROMACTA
N 022291 001 6280959
6280959
7160870
7160870
7332481
7332481
7452874
7473686
7473686
7547719
7547719
7790704
7790704
7795293
7795293
8052993
8052993
ELTROMBOPAG OLAMINE - PROMACTA
N 022291 002 6280959
6280959
7160870
7160870
7332481
7332481
7452874
7473686
7473686
7547719
7547719
7790704
7790704
7795293
7795293
8052994
8052994
ELTROMBOPAG OLAMINE - PROMACTA
N 022291 003 6280959
6280959
7160870
7160870
7332481
7332481
7452874
7473686
7473686
7547719
7547719
7790704
7790704
7795293
7795293
8062665
8062665
PATENT
EXPIRATION
DATE
Oct 30, 2018
Oct 30, 2018
Nov 20, 2022
Nov 20, 2022
May 24, 2021
May 24, 2021
May 24, 2021
May 24, 2021
May 24, 2021
Jul 13, 2025
Jul 13, 2025
May 24, 2021
May 24, 2021
May 21, 2023
May 21, 2023
Aug 01, 2027
Aug 01, 2027
Oct 30, 2018
Oct 30, 2018
Nov 20, 2022
Nov 20, 2022
May 24, 2021
May 24, 2021
May 24, 2021
May 24, 2021
May 24, 2021
Jul 13, 2025
Jul 13, 2025
May 24, 2021
May 24, 2021
May 21, 2023
May 21, 2023
Aug 01, 2027
Aug 01, 2027
Oct 30, 2018
Oct 30, 2018
Nov 20, 2022
Nov 20, 2022
May 24, 2021
May 24, 2021
May 24, 2021
May 24, 2021
May 24, 2021
Jul 13, 2025
Jul 13, 2025
May 24, 2021
May 24, 2021
May 21, 2023
May 21, 2023
Aug 01, 2027
Aug 01, 2027
PATENT EXCLUSIVITY
PATENT DELIST EXCLUSIVITY EXPIRATION
CODES REQUESTED CODE(S) DATE
DS DP U-930 I-664 Nov 16, 2015
DS DP U-1306 NCE Nov 20, 2013
DS DP U-930 ODE Nov 20, 2015
DS DP U-1306
U-930
U-1306
DS DP
DS DP U-930
DS DP U-1306
DS DP U-930
DS DP U-1306
U-930
U-1306
U-930
U-1306
DP U-930
DP U-1306
DS DP U-930 I-664 Nov 16, 2015
DS DP U-1306 NCE Nov 20, 2013
DS DP U-930 ODE Nov 20, 2015
DS DP U-1306
U-930
U-1306
DS DP
DS DP U-930
DS DP U-1306
DS DP U-930
DS DP U-1306
U-930
U-1306
U-930
U-1306
DP U-930
DP U-1306
DS DP U-930 I-664 Nov 16, 2015
DS DP U-1306 NCE Nov 20, 2013
DS DP U-930 ODE Nov 20, 2015
DS DP U-1306
U-930
U-1306
DS DP
DS DP U-930
DS DP U-1306
DS DP U-930
DS DP U-1306
U-930
U-1306
U-930
U-1306
DP U-930
DP U-1306
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 59 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY
DATE CODES REQUESTED CODE(S)
ELTROMBOPAG OLAMINE - PROMACTA
N 022291 004 6280959 Oct 30, 2018 DS DP U-930 I-664
6280959 Oct 30, 2018 DS DP U-1306 NCE
7160870 Nov 20, 2022 DS DP U-930 ODE
7160870 Nov 20, 2022 DS DP U-1306
7332481 May 24, 2021 U-930
7332481 May 24, 2021 U-1306
7452874 May 24, 2021 DS DP
7473686 May 24, 2021 DS DP U-930
7473686 May 24, 2021 DS DP U-1306
7547719 Jul 13, 2025 DS DP U-930
7547719 Jul 13, 2025 DS DP U-1306
7790704 May 24, 2021 U-930
7790704 May 24, 2021 U-1306
7795293 May 21, 2023 U-930
7795293 May 21, 2023 U-1306
8071129 Aug 01, 2027 DP U-930
8071129 Aug 01, 2027 DP U-1306
ELTROMBOPAG OLAMINE - PROMACTA
N 022291 005 6280959 Oct 30, 2018 DS DP U-930 I-664
6280959 Oct 30, 2018 DS DP U-1306 NCE
7160870 Nov 20, 2022 DS DP U-930 ODE
7160870 Nov 20, 2022 DS DP U-1306
7332481 May 24, 2021 U-930
7332481 May 24, 2021 U-1306
7452874 May 24, 2021 DS DP
7473686 May 24, 2021 DS DP U-930
7473686 May 24, 2021 DS DP U-1306
7547719 Jul 13, 2025 DS DP U-930
7547719 Jul 13, 2025 DS DP U-1306
7790704 May 24, 2021 U-930
7790704 May 24, 2021 U-1306
7795293 May 21, 2023 U-930
7795293 May 21, 2023 U-1306
8052995 Aug 01, 2027 DP U-1306
EMEDASTINE DIFUMARATE - EMADINE
N 020706 001 5441958 Dec 08, 2013 U-404
EMTRICITABINE - EMTRIVA
N 021500 001 5814639 Sep 29, 2015 DS DP
5914331 Jul 02, 2017 DS
6642245 Nov 04, 2020 U-257
6642245 Nov 04, 2020 U-541
6703396 Mar 09, 2021 DS DP
EMTRICITABINE - EMTRIVA
N 021896 001 5814639 Sep 29, 2015 DS DP
5914331 Jul 02, 2017 DS
6642245 Nov 04, 2020 U-257
6703396 Mar 09, 2021 DS DP
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE - COMPLERA
N 202123 001 5814639 Sep 29, 2015 DS DP NCE
5914331 Jul 02, 2017 DS NPP
5922695 Jul 25, 2017 DS U-257
5935946 Jul 25, 2017 DS DP U-257
5977089 Jul 25, 2017 DS DP U-257
6043230 Jul 25, 2017 U-257
6642245 Nov 04, 2020 U-257
6703396 Mar 09, 2021 DS DP
6838464 Feb 26, 2021 DS DP
7067522 Dec 20, 2019 DS DP
7125879 Apr 14, 2023 DS DP U-257
8080551 Apr 11, 2023 DS DP
8101629 Aug 09, 2022 DP
8592397 Jan 13, 2024 DP U-257
EXCLUSIVITY
EXPIRATION
DATE
Nov 16, 2015
Nov 20, 2013
Nov 20, 2015
Nov 16, 2015
Nov 20, 2013
Nov 20, 2015
May 20, 2016
Dec 13, 2016
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 60 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - TRUVADA
N 021752 001 5814639 Sep 29, 2015 DS DP
5914331 Jul 02, 2017 DS DP U-248
5922695 Jul 25, 2017 DS U-248
5922695 Jul 25, 2017 DS U-541
5922695 Jul 25, 2017 DS U-1170
5922695 Jul 25, 2017 DS U-1259
5935946 Jul 25, 2017 DS DP U-248
5935946 Jul 25, 2017 DS DP U-541
5935946 Jul 25, 2017 DS DP U-1170
5935946 Jul 25, 2017 DS DP U-1259
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-541
5977089 Jul 25, 2017 DS DP U-1170
5977089 Jul 25, 2017 DS DP U-1259
6043230 Jul 25, 2017 DP U-248
6043230 Jul 25, 2017 DP U-541
6043230 Jul 25, 2017 DP U-1170
6043230 Jul 25, 2017 DP U-1259
6642245 Nov 04, 2020 U-248
6642245 Nov 04, 2020 U-541
6642245 Nov 04, 2020 U-1170
6703396 Mar 09, 2021 DS DP
8592397 Jan 13, 2024 DP U-248
8592397 Jan 13, 2024 DP U-541
8592397 Jan 13, 2024 DP U-1170
ENALAPRIL MALEATE - EPANED KIT
N 204308 001 8568747 Nov 06, 2032 DP
ENFUVIRTIDE - FUZEON
N 021481 001 6133418 Nov 17, 2014 DS DP
6475491 Jun 07, 2015 U-248
ENTACAPONE - COMTAN
N 020796 001 5446194 Oct 19, 2013 DS
6599530 Sep 14, 2018 DP U-219
ENTECAVIR - BARACLUDE
N 021797 001 5206244 Feb 21, 2015 DS D-127 Oct 15, 2013
5206244*PED Aug 21, 2015 NPP Oct 12, 2015
NPP Oct 12, 2015
PED Apr 12, 2016
PED Apr 12, 2016
PED Apr 15, 2014
ENTECAVIR - BARACLUDE
N 021797 002 5206244 Feb 21, 2015 DS D-127 Oct 15, 2013
5206244*PED Aug 21, 2015 NPP Oct 12, 2015
NPP Oct 12, 2015
PED Apr 12, 2016
PED Apr 15, 2014
PED Apr 12, 2016
ENTECAVIR - BARACLUDE
N 021798 001 5206244 Feb 21, 2015 DS D-127 Oct 15, 2013
5206244*PED Aug 21, 2015 NPP Oct 12, 2015
NPP Oct 12, 2015
PED Apr 12, 2016
PED Apr 12, 2016
PED Apr 15, 2014
ENZALUTAMIDE - XTANDI
N 203415 001 7709517 Aug 13, 2027 DS DP NCE Aug 31, 2017
8183274 May 15, 2026 U-1281
EPINEPHRINE - EPIPEN
N 019430 001 7449012 Sep 11, 2025 DP
7794432 Sep 11, 2025 DP
8048035 Sep 11, 2025 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 61 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
EPINEPHRINE - EPIPEN JR.
N 019430 002 7449012 Sep 11, 2025 DP
7794432 Sep 11, 2025 DP
8048035 Sep 11, 2025 DP
EPINEPHRINE - TWINJECT 0.3
N 020800 001 7297136 Jan 18, 2025 DP
7621891 Feb 04, 2025 DP
EPINEPHRINE - TWINJECT 0.15
N 020800 002 7297136 Jan 18, 2025 DP
7621891 Feb 04, 2025 DP
EPINEPHRINE - AUVI-Q
N 201739 001 7731686 Jun 01, 2026 DP
7731690 Jan 15, 2025 DP
7749194 Oct 30, 2028 DP
7918823 Nov 23, 2024 DP
7947017 Mar 12, 2028 DP
8016788 Mar 21, 2025 DP
8021344 Nov 02, 2029 DP
8206360 Feb 27, 2027 DP
8226610 Apr 10, 2029 DP
8231573 Nov 25, 2028 DP
8313466 Nov 23, 2024 DP
8361029 Nov 23, 2024 DP
8425462 Nov 23, 2024 DP
EPINEPHRINE - AUVI-Q
N 201739 002 7731686 Jun 01, 2026 DP
7731690 Jan 15, 2025 DP
7749194 Oct 30, 2028 DP
7918823 Nov 23, 2024 DP
7947017 Mar 12, 2028 DP
8016788 Mar 21, 2025 DP
8021344 Nov 02, 2029 DP
8206360 Feb 27, 2027 DP
8226610 Apr 10, 2029 DP
8231573 Nov 25, 2028 DP
8313466 Nov 23, 2024 DP
8361029 Nov 23, 2024 DP
8425462 Nov 23, 2024 DP
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE - LIDOSITE TOPICAL SYSTEM KIT
N 021504 001 5246418 Sep 30, 2013 DS DP
5873850 Sep 30, 2013 DS DP
6377847 Sep 30, 2013 DS DP
6385488 Sep 30, 2013 DS DP
6629968 Jun 30, 2020 DS DP
6635045 Jun 29, 2021 DS DP
6862473 Sep 30, 2013 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 62 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
EPLERENONE - INSPRA
N 021437 001 6410054 Dec 08, 2019 U-3
6410054 Dec 08, 2019 U-537
6410524 Nov 05, 2019 U-467
6495165 Dec 08, 2019 U-3
6495165 Dec 08, 2019 U-537
6534093 Dec 08, 2019 U-3
6534093 Dec 08, 2019 U-537
6558707 Dec 08, 2019 DP U-537
6747020 Nov 05, 2019 U-587
7157101 Dec 08, 2019 DP U-664
EPLERENONE - INSPRA
N 021437 002 6410054 Dec 08, 2019 U-3
6410054 Dec 08, 2019 U-537
6410524 Nov 05, 2019 U-467
6495165 Dec 08, 2019 U-3
6495165 Dec 08, 2019 U-537
6534093 Dec 08, 2019 U-3
6534093 Dec 08, 2019 U-537
6558707 Dec 08, 2019 DP U-537
6747020 Nov 05, 2019 U-587
7157101 Dec 08, 2019 DP U-664
EPLERENONE - INSPRA
N 021437 003 6410054 Dec 08, 2019 U-3
6410054 Dec 08, 2019 U-537
6410524 Nov 05, 2019 U-467
6495165 Dec 08, 2019 U-3
6495165 Dec 08, 2019 U-537
6534093 Dec 08, 2019 U-3
6534093 Dec 08, 2019 U-537
6558707 Dec 08, 2019 DP U-537
6747020 Nov 05, 2019 U-587
7157101 Dec 08, 2019 DP U-664
EPOPROSTENOL SODIUM - VELETRI
N 022260 001 8318802 Mar 15, 2027 DP
8598227 Feb 02, 2027
EPOPROSTENOL SODIUM - VELETRI
N 022260 002 8318802 Mar 15, 2027 DP
8598227 Feb 02, 2027
EPROSARTAN MESYLATE - TEVETEN
N 020738 004 5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE - TEVETEN
N 020738 005 5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE - TEVETEN
N 020738 006 5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE - TEVETEN HCT
N 021268 001 5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE - TEVETEN HCT
N 021268 002 5656650 Aug 12, 2014 U-3
EPTIFIBATIDE - INTEGRILIN
N 020718 001 5686570 Nov 11, 2014
5747447 May 05, 2015
5756451 Nov 11, 2014
5807825 Sep 15, 2015 U-244
5968902 Jun 02, 2015 U-453
EPTIFIBATIDE - INTEGRILIN
N 020718 002 5686570 Nov 11, 2014
5747447 May 05, 2015
5756451 Nov 11, 2014
5807825 Sep 15, 2015 U-244
5968902 Jun 02, 2015 U-453
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 63 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ERIBULIN MESYLATE - HALAVEN
N 201532 001 6214865
6469182
7470720
8097648
Jun 16, 2019
Jun 16, 2019
Jun 16, 2019
Jan 22, 2021
DS
U-1096
DP
U-1096
NCE Nov 15, 2015
ERLOTINIB HYDROCHLORIDE - TARCEVA
N 021743 001 5747498
6900221
6900221
6900221
6900221
7087613
7087613
7087613
RE41065
Nov 08, 2018
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 08, 2018
DS DP U-659
DS DP U-659
DS DP U-875
DS DP U-1046
DS DP U-1403
U-659
U-1045
U-1403
DS DP
I-671 May 14, 2016
ERLOTINIB HYDROCHLORIDE - TARCEVA
N 021743 002 5747498
6900221
6900221
6900221
6900221
7087613
7087613
7087613
RE41065
Nov 08, 2018
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 08, 2018
DS DP U-659
DS DP U-659
DS DP U-875
DS DP U-1046
DS DP U-1403
U-659
U-1045
U-1403
DS DP
I-671 May 14, 2016
ERLOTINIB HYDROCHLORIDE - TARCEVA
N 021743 003 5747498
6900221
6900221
6900221
6900221
7087613
7087613
7087613
RE41065
Nov 08, 2018
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 09, 2020
Nov 08, 2018
DS DP U-659
DS DP U-659
DS DP U-875
DS DP U-1046
DS DP U-1403
U-659
U-1045
U-1403
DS DP
I-671 May 14, 2016
ERTAPENEM SODIUM - INVANZ
N 021337 001 5478820
5952323
Nov 21, 2015
May 15, 2017
DS DP U-160
DP
ESCITALOPRAM OXALATE - LEXAPRO
N 021323 001 6916941
7420069
ESCITALOPRAM OXALATE - LEXAPRO
Aug 12, 2022
Aug 12, 2022
DS DP
DP
N 021323 002 6916941
7420069
ESCITALOPRAM OXALATE - LEXAPRO
Aug 12, 2022
Aug 12, 2022
DS DP
DP
N 021323 003 6916941
7420069
Aug 12, 2022
Aug 12, 2022
DS DP
DP
ESLICARBAZEPINE ACETATE - APTIOM
N 022416 001 5753646 Jun 27, 2016
8372431 Apr 17, 2030
ESLICARBAZEPINE ACETATE - APTIOM
DS DP U-1451
DP
NCE Nov 08, 2018
N 022416 002 5753646 Jun 27, 2016
8372431 Apr 17, 2030
ESLICARBAZEPINE ACETATE - APTIOM
DS DP U-1451
DP
NCE Nov 08, 2018
N 022416 003 5753646 Jun 27, 2016
8372431 Apr 17, 2030
ESLICARBAZEPINE ACETATE - APTIOM
DS DP U-1451
DP
NCE Nov 08, 2018
N 022416 004 5753646
8372431
Jun 27, 2016
Apr 17, 2030
DS DP U-1451
DP
NCE Nov 08, 2018
ESMOLOL HYDROCHLORIDE - BREVIBLOC IN PLASTIC CONTAINER
N 019386 004 6310094 Jan 12, 2021
6528540 Jan 12, 2021
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 64 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PATENT
EXPIRATION PATENT
PATENT
DELIST EXCLUSIVITY
EXCLUSIVITY
EXPIRATION
CODES DATE REQUESTED
ESMOLOL HYDROCHLORIDE - BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
CODE(S) DATE
N 019386 005 6310094 Jan 12, 2021
6528540 Jan 12, 2021
ESMOLOL HYDROCHLORIDE - BREVIBLOC
N 019386 006 6310094 Jan 12, 2021
6528540 Jan 12, 2021
ESMOLOL HYDROCHLORIDE - BREVIBLOC
N 019386 007 6310094 Jan 12, 2021
6528540 Jan 12, 2021
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 65 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021153 001 5690960 Nov 25, 2014 DP U-373
5690960 Nov 25, 2014 DP U-729
5690960 Nov 25, 2014 DP U-770
5714504 Feb 03, 2015 DP U-373
5714504 Feb 03, 2015 DP U-729
5714504 Feb 03, 2015 DP U-770
5877192 May 27, 2014 DP U-373
5877192 May 27, 2014 DP U-729
5877192 May 27, 2014 DP U-770
5900424 May 04, 2016 DS U-373
5900424 May 04, 2016 DS U-729
5900424 May 04, 2016 DS U-770
6147103 Oct 09, 2018
6166213 Oct 09, 2018
6191148 Oct 09, 2018
6369085 May 25, 2018 DS DP U-729
6369085 May 25, 2018 DS DP U-770
6428810 Nov 03, 2019 DP U-469
6428810 Nov 03, 2019 DP U-729
6428810 Nov 03, 2019 DP U-770
6875872 May 27, 2014 DS
7411070 May 25, 2018 DS
8466175 May 25, 2018 U-1417
8466175*PED Nov 25, 2018
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021153 002 5690960 Nov 25, 2014 DP U-373
5690960 Nov 25, 2014 DP U-729
5690960 Nov 25, 2014 DP U-770
5714504 Feb 03, 2015 DP U-373
5714504 Feb 03, 2015 DP U-729
5714504 Feb 03, 2015 DP U-770
5877192 May 27, 2014 DP U-373
5877192 May 27, 2014 DP U-729
5877192 May 27, 2014 DP U-770
5900424 May 04, 2016 DS U-373
5900424 May 04, 2016 DS U-729
5900424 May 04, 2016 DS U-770
6147103 Oct 09, 2018
6166213 Oct 09, 2018
6191148 Oct 09, 2018
6369085 May 25, 2018 DS DP U-729
6369085 May 25, 2018 DS DP U-770
6428810 Nov 03, 2019 DP U-469
6428810 Nov 03, 2019 DP U-729
6428810 Nov 03, 2019 DP U-770
6875872 May 27, 2014 DS
7411070 May 25, 2018 DS
8466175 May 25, 2018 U-1417
8466175*PED Nov 25, 2018
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021957 001
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 66 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
6428810 Nov 03, 2019 DP U-1207
6875872 May 27, 2014 DS
7411070 May 25, 2018 DS
8466175 May 25, 2018 U-1417
8466175*PED Nov 25, 2018
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021957 002 5690960 Nov 25, 2014 DP U-729
5690960 Nov 25, 2014 DP U-773
5690960 Nov 25, 2014 DP U-1207
5714504 Feb 03, 2015 DP U-729
5714504 Feb 03, 2015 DP U-773
5714504 Feb 03, 2015 DP U-1207
5877192 May 27, 2014 U-729
5877192 May 27, 2014 U-773
5877192 May 27, 2014 U-1207
5900424 May 04, 2016 DS U-729
5900424 May 04, 2016 DS U-773
5900424 May 04, 2016 DS U-1207
6369085 May 25, 2018 DS DP U-729
6369085 May 25, 2018 DS DP U-773
6369085 May 25, 2018 DS DP U-1207
6428810 Nov 03, 2019 DP U-729
6428810 Nov 03, 2019 DP U-773
6428810 Nov 03, 2019 DP U-1207
6875872 May 27, 2014 DS
7411070 May 25, 2018 DS
8466175 May 25, 2018 U-1417
8466175*PED Nov 25, 2018
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021957 003 5690960 Nov 25, 2014 DP U-1207
5714504 Feb 03, 2015 DP U-1207
5877192 May 27, 2014 U-1207
5900424 May 04, 2016 DS U-1207
6369085 May 25, 2018 DS DP U-1207
6428810 Nov 03, 2019 DP U-1207
6875872 May 27, 2014 DS
7411070 May 25, 2018 DS
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021957 004 5690960 Nov 25, 2014 DP U-1207
5714504 Feb 03, 2015 DP U-1207
5877192 May 27, 2014 U-1207
5900424 May 04, 2016 DS U-1207
6369085 May 25, 2018 DS DP U-1207
6428810 Nov 03, 2019 DP U-1207
6875872 May 27, 2014 DS
7411070 May 25, 2018 DS
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 022101 001 5690960 Nov 25, 2014 DP U-858
5714504 Feb 03, 2015 DP U-858
5877192 May 27, 2014 U-858
5900424 May 04, 2016 DS U-858
6369085 May 25, 2018 DS DP U-858
6428810 Nov 03, 2019 DP U-858
6875872 May 27, 2014 DS
7411070 May 25, 2018 DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 67 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO
N 022511 001 5714504 Feb 03, 2015 DP U-1053
5900424 May 04, 2016 DS U-1053
6369085 May 25, 2018 DS DP U-1053
6875872 May 27, 2014 DS
6926907 Feb 28, 2023 DP U-1052
7411070 May 25, 2018 DS U-1053
7745466 Oct 13, 2018 DP U-1053
8557285 May 31, 2022 DP
ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO
N 022511 002 5714504 Feb 03, 2015 DP U-1053
5900424 May 04, 2016 DS U-1053
6369085 May 25, 2018 DS DP U-1053
6875872 May 27, 2014 DS
6926907 Feb 28, 2023 DP U-1052
7411070 May 25, 2018 DS U-1053
7745466 Oct 13, 2018 DP U-1053
8557285 May 31, 2022 DP
ESOMEPRAZOLE SODIUM - NEXIUM IV
N 021689 001 5877192 May 27, 2014 U-643
6143771 May 27, 2014 DP U-643
ESOMEPRAZOLE SODIUM - NEXIUM IV
N 021689 002 5877192 May 27, 2014 U-643
6143771 May 27, 2014 DP U-643
ESTRADIOL - VIVELLE-DOT
N 020538 005 5656286 Aug 12, 2014
6024976 Jan 07, 2014
ESTRADIOL - VIVELLE-DOT
N 020538 006 5656286 Aug 12, 2014
6024976 Jan 07, 2014
ESTRADIOL - VIVELLE-DOT
N 020538 007 5656286 Aug 12, 2014
6024976 Jan 07, 2014
ESTRADIOL - VIVELLE-DOT
N 020538 008 5656286 Aug 12, 2014
6024976 Jan 07, 2014
ESTRADIOL - VIVELLE-DOT
N 020538 009 5656286 Aug 12, 2014 DP
6024976 Jan 07, 2014 DP
ESTRADIOL - VAGIFEM
N 020908 002 5860946 Jul 01, 2017 DP
7018992 Sep 17, 2022 U-1023
ESTRADIOL - MENOSTAR
N 021674 001 5891868 Nov 21, 2017 DP U-594
6692763 Nov 21, 2017 DP U-594
ESTRADIOL - ELESTRIN
N 021813 001 7198801 Jun 25, 2022 DP
7470433 Aug 03, 2021 DP
ESTRADIOL - EVAMIST
N 022014 001 6299900 Feb 19, 2017 DP U-888
6299900 Feb 19, 2017 DP U-889
6818226 Feb 19, 2017 DP U-888
6818226 Feb 19, 2017 DP U-889
6923983 Feb 19, 2017 DP U-888
6923983 Feb 19, 2017 DP U-889
6978945 Nov 30, 2021 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 68 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ESTRADIOL - MINIVELLE
N 203752 001 5656286 Aug 12, 2014 DS DP
6024976 Jan 07, 2014 DS DP
6841716 Apr 27, 2020 DP
8231906 Jul 04, 2030 DS DP
ESTRADIOL - MINIVELLE
N 203752 002 5656286 Aug 12, 2014 DS DP
6024976 Jan 07, 2014 DS DP
6841716 Apr 27, 2020 DP
8231906 Jul 04, 2030 DS DP
ESTRADIOL - MINIVELLE
N 203752 003 5656286 Aug 12, 2014 DS DP
6024976 Jan 07, 2014 DS DP
6841716 Apr 27, 2020 DP
8231906 Jul 04, 2030 DS DP
ESTRADIOL - MINIVELLE
N 203752 004 5656286 Aug 12, 2014 DS DP
6024976 Jan 07, 2014 DS DP
6841716 Apr 27, 2020 DP
8231906 Jul 04, 2030 DS DP
ESTRADIOL ACETATE - FEMRING
N 021367 001 5855906 Dec 19, 2015 U-508
ESTRADIOL ACETATE - FEMRING
N 021367 002 5855906 Dec 19, 2015 U-508
ESTRADIOL ACETATE - FEMTRACE
N 021633 001 6962908 Dec 21, 2021 DP
7572779 Oct 02, 2025 U-904
7799771 Dec 21, 2021 DP
ESTRADIOL ACETATE - FEMTRACE
N 021633 002 6962908 Dec 21, 2021 DP
7572779 Oct 02, 2025 U-904
7799771 Dec 21, 2021 DP
ESTRADIOL ACETATE - FEMTRACE
N 021633 003 6962908 Dec 21, 2021 DP
7572779 Oct 02, 2025 U-904
7799771 Dec 21, 2021 DP
ESTRADIOL HEMIHYDRATE - ESTRASORB
N 021371 001 5629021 Jan 31, 2015 DP
ESTRADIOL; ESTRADIOL; NORGESTIMATE - PREFEST
N 021040 001 6747019 Mar 20, 2020 U-311
7320970 Mar 30, 2020 DP U-844
ESTRADIOL; LEVONORGESTREL - CLIMARA PRO
N 021258 001 5676968 Oct 14, 2014 DP
ESTRADIOL; NORETHINDRONE ACETATE - COMBIPATCH
N 020870 001 5656286 Aug 12, 2014
6024976 Jan 07, 2014
ESTRADIOL; NORETHINDRONE ACETATE - COMBIPATCH
N 020870 002 5656286 Aug 12, 2014
6024976 Jan 07, 2014
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N 020992 001 5908638 Jul 26, 2015 DP
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N 020992 002 5908638 Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N 020992 003 5908638 Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N 020992 004 5908638 Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N 020992 005 5908638 Jul 26, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 69 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N 021443 001 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N 021443 002 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N 021443 003 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N 021443 004 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N 021443 005 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED; ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPHASE 14/14
N 020527 002 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE; MEDROXYPROGESTERONE ACETATE -
PREMPRO
N 020527 001 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE; MEDROXYPROGESTERONE ACETATE -
PREMPRO
N 020527 003 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO
N 020527 004 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO
N 020527 005 5547948 Jan 17, 2015
ESZOPICLONE - LUNESTA
N 021476 001 6444673 Feb 14, 2014 DS DP M-61 Oct 10, 2015
PED Apr 10, 2016
ESZOPICLONE - LUNESTA
N 021476 002 6444673 Feb 14, 2014 DS DP M-61 Oct 10, 2015
PED Apr 10, 2016
ESZOPICLONE - LUNESTA
N 021476 003 6444673 Feb 14, 2014 DS DP M-61 Oct 10, 2015
PED Apr 10, 2016
ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; NORGESTIMATE; NORGESTIMATE; NORGESTIMATE - ORTHO
TRI-CYCLEN LO
N 021241 001 6214815 Jun 09, 2019 U-112
ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; LEVONORGESTREL - SEASONIQUE
N 021840 001 7320969 Jan 30, 2024 U-828
7615545 Jun 15, 2023 U-1
7855190 Dec 05, 2028 U-1
7858605 Jun 23, 2023 DP
ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; LEVONORGESTREL - LOSEASONIQUE
N 022262 001 7615545 Jun 15, 2023 U-1
7855190 Dec 05, 2028 U-1
7858605 Jun 23, 2023 DP
ETHINYL ESTRADIOL; ETONOGESTREL - NUVARING
N 021187 001 5989581 Apr 08, 2018
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 70 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ETHINYL ESTRADIOL; LEVONORGESTREL - PREVEN EMERGENCY CONTRACEPTIVE KIT
N 020946 001 6156742 Dec 05, 2020 U-374
ETHINYL ESTRADIOL; LEVONORGESTREL - SEASONALE
N 021544 001 5898032 Jun 23, 2017 U-1
RE39861 Jun 23, 2017 U-828
ETHINYL ESTRADIOL; LEVONORGESTREL - LYBREL
N 021864 001 6500814 Sep 03, 2018 U-1
ETHINYL ESTRADIOL; LEVONORGESTREL - QUARTETTE
N 204061 001 8415332 Mar 11, 2029 DP NP Mar 28, 2016
8450299 Oct 07, 2025 U-1
ETHINYL ESTRADIOL; NORELGESTROMIN - ORTHO EVRA
N 021180 001 5876746 Nov 20, 2015 DP U-514
5972377 Jun 07, 2015 U-514
ETHINYL ESTRADIOL; NORETHINDRONE - FEMCON FE
N 021490 001 6667050 Apr 06, 2019 DP U-1
ETHINYL ESTRADIOL; NORETHINDRONE - NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
N 022573 001 5552394 Jul 22, 2014 U-828 NP Dec 22, 2013
6667050 Apr 06, 2019 DP U-828
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LOESTRIN 24 FE
N 021871 001 5552394 Jul 22, 2014 U-1
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LO LOESTRIN FE
N 022501 001 5552394 Jul 22, 2014 U-1090 NP Oct 21, 2013
7704984 Feb 02, 2029 U-1090
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - MINASTRIN 24 FE
N 203667 001 5552394 Jul 22, 2014 U-1 NDF May 08, 2016
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
N 204426 001 5552394 Jul 22, 2014 U-1
6652880 Mar 29, 2020 DP
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LO MINASTRIN FE
N 204654 001 5552394 Jul 22, 2014 U-1
6667050 Apr 06, 2019 DP U-1
7704984 Feb 02, 2029 U-1
ETONOGESTREL - NEXPLANON
N 021529 002 NP May 31, 2014
ETRAVIRINE - INTELENCE
N 022187 001 6878717 Nov 05, 2019 U-256 NPP Mar 26, 2015
6878717 Nov 05, 2019 U-1016
6878717 Nov 05, 2019 U-1237
7037917 Dec 13, 2020 DS DP U-256
7037917 Dec 13, 2020 DS DP U-1016
7037917 Dec 13, 2020 DS DP U-1237
7887845 Mar 25, 2019 DP
8003789 Nov 01, 2019 DS DP
ETRAVIRINE - INTELENCE
N 022187 002 6878717 Nov 05, 2019 U-256 NPP Mar 26, 2015
6878717 Nov 05, 2019 U-1016
6878717 Nov 05, 2019 U-1237
7037917 Dec 13, 2020 DS DP U-256
7037917 Dec 13, 2020 DS DP U-1016
7037917 Dec 13, 2020 DS DP U-1237
7887845 Mar 25, 2019 DP
8003789 Nov 01, 2019 DS DP
ETRAVIRINE - INTELENCE
N 022187 003 6878717 Nov 05, 2019 U-256 NPP Mar 26, 2015
6878717 Nov 05, 2019 U-1016
6878717 Nov 05, 2019 U-1237
7037917 Dec 13, 2020 DS DP U-1237
7887845 Mar 25, 2019 DP
8003789 Nov 01, 2019 DS DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 71 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
EVEROLIMUS - ZORTRESS
N 021560 001 5665772
5665772
5665772*PED
6004973
6004973
6004973*PED
6239124
6440990
6440990
6440990*PED
6455518
6455518
6455518*PED
EVEROLIMUS - ZORTRESS
N 021560 002 5665772
5665772
5665772*PED
6004973
6004973
6004973*PED
6239124
6440990
6440990
6440990*PED
6455518
6455518
6455518*PED
EVEROLIMUS - ZORTRESS
N 021560 003 5665772
5665772
5665772*PED
6004973
6004973
6004973*PED
6239124
6440990
6440990
6440990*PED
6455518
6455518
6455518*PED
PATENT
EXPIRATION
DATE
Sep 09, 2019
Sep 09, 2019
Mar 09, 2020
Jul 12, 2016
Jul 12, 2016
Jan 12, 2017
Aug 11, 2017
Sep 24, 2013
Sep 24, 2013
Mar 24, 2014
Jul 29, 2017
Jul 29, 2017
Jan 29, 2018
Sep 09, 2019
Sep 09, 2019
Mar 09, 2020
Jul 12, 2016
Jul 12, 2016
Jan 12, 2017
Aug 11, 2017
Sep 24, 2013
Sep 24, 2013
Mar 24, 2014
Jul 29, 2017
Jul 29, 2017
Jan 29, 2018
Sep 09, 2019
Sep 09, 2019
Mar 09, 2020
Jul 12, 2016
Jul 12, 2016
Jan 12, 2017
Aug 11, 2017
Sep 24, 2013
Sep 24, 2013
Mar 24, 2014
Jul 29, 2017
Jul 29, 2017
Jan 29, 2018
PATENT
PATENT DELIST
CODES REQUESTED
DS DP U-1049
DS DP U-1365
DP U-1049
DP U-1365
U-1049
DP U-1049
DP U-1365
U-1049
U-1365
DS DP U-1049
DS DP U-1365
DP U-1049
DP U-1365
U-1049
DP U-1049
DP U-1365
U-1049
U-1365
DS DP U-1049
DS DP U-1365
DP U-1049
DP U-1365
U-1049
DP U-1049
DP U-1365
U-1049
U-1365
EXCLUSIVITY
EXCLUSIVITY EXPIRATION
CODE(S) DATE
I-668 Feb 15, 2016
NCE Mar 30, 2014
PED Oct 20, 2013
PED Sep 30, 2014
I-668 Feb 15, 2016
NCE Mar 30, 2014
PED Oct 20, 2013
PED Sep 30, 2014
I-668 Feb 15, 2016
NCE Mar 30, 2014
PED Sep 30, 2014
PED Oct 20, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 72 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
EVEROLIMUS - AFINITOR
N 022334 001 5665772
6004973
7297703
8410131
8410131*PED
8436010
8436010*PED
EVEROLIMUS - AFINITOR
N 022334 002 5665772
6004973
7297703
8410131
8410131*PED
8436010
8436010*PED
EVEROLIMUS - AFINITOR
N 022334 003 5665772
6004973
7297703
8410131
8410131*PED
8436010
8436010*PED
EVEROLIMUS - AFINITOR
N 022334 004 5665772
6004973
7297703
8410131
8410131*PED
8436010
8436010*PED
PATENT
EXPIRATION
DATE
Sep 09, 2019
Jul 12, 2016
Dec 06, 2019
May 22, 2025
Nov 22, 2025
Feb 22, 2022
Aug 22, 2022
Sep 09, 2019
Jul 12, 2016
Dec 06, 2019
May 22, 2025
Nov 22, 2025
Feb 22, 2022
Aug 22, 2022
Sep 09, 2019
Jul 12, 2016
Dec 06, 2019
May 22, 2025
Nov 22, 2025
Feb 22, 2022
Aug 22, 2022
Sep 09, 2019
Jul 12, 2016
Dec 06, 2019
May 22, 2025
Nov 22, 2025
Feb 22, 2022
Aug 22, 2022
PATENT
CODES
DS DP
DP
DP
DS DP U-1368
DS DP U-1396
PATENT
DELIST
REQUESTED
DS DP
DP
DP
DS DP U-1368
DS DP U-1396
DS DP
DP
DP
DS DP U-1368
DS DP U-1396
DS DP
DP
DP
DS DP U-1368
DS DP U-1396
EXCLUSIVITY
EXCLUSIVITY EXPIRATION
CODE(S) DATE
I-630 Oct 29, 2013
I-638 May 05, 2014
I-650 Apr 26, 2015
I-655 Jul 20, 2015
NCE Mar 30, 2014
ODE Oct 29, 2017
ODE Apr 26, 2019
ODE May 05, 2018
PED Oct 26, 2015
PED Apr 29, 2018
PED Oct 26, 2019
PED Sep 30, 2014
PED Nov 05, 2018
PED Nov 05, 2014
PED Apr 29, 2014
I-630 Oct 29, 2013
I-638 May 05, 2014
I-650 Apr 26, 2015
I-655 Jul 20, 2015
NCE Mar 30, 2014
ODE Apr 26, 2019
ODE Oct 29, 2017
ODE May 05, 2018
PED Apr 29, 2018
PED Oct 26, 2015
PED Nov 05, 2018
PED Nov 05, 2014
PED Sep 30, 2014
PED Oct 26, 2019
PED Apr 29, 2014
I-630 Oct 29, 2013
I-638 May 05, 2014
I-650 Apr 26, 2015
I-655 Jul 20, 2015
NCE Mar 30, 2014
ODE Apr 26, 2019
ODE May 05, 2018
ODE Oct 29, 2017
PED Oct 26, 2015
PED Oct 26, 2019
PED Apr 29, 2014
PED Apr 29, 2018
PED Nov 05, 2014
PED Sep 30, 2014
PED Nov 05, 2018
I-630 Oct 29, 2013
I-638 May 05, 2014
I-650 Apr 26, 2015
I-655 Jul 20, 2015
NCE Mar 30, 2014
ODE May 05, 2018
ODE Apr 26, 2019
ODE Oct 29, 2017
PED Sep 30, 2014
PED Oct 26, 2019
PED Apr 29, 2018
PED Nov 05, 2018
PED Nov 05, 2014
PED Oct 26, 2015
PED Apr 29, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 73 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PATENT
EXPIRATION PATENT
PATENT
DELIST EXCLUSIVITY
EXCLUSIVITY
EXPIRATION
EVEROLIMUS - AFINITOR DISPERZ
DATE CODES REQUESTED CODE(S) DATE
N 203985 001 5665772
6004973
7297703
Sep 09, 2019
Jul 12, 2016
Dec 06, 2019
DS DP
DP
DP
I-630
NCE
ODE
PED
PED
PED
Oct 29, 2013
Mar 30, 2014
Oct 29, 2017
Apr 29, 2018
Sep 30, 2014
Apr 29, 2014
EVEROLIMUS - AFINITOR DISPERZ
N 203985 002 5665772
6004973
7297703
Sep 09, 2019
Jul 12, 2016
Dec 06, 2019
DS DP
DP
DP
I-630
NCE
ODE
PED
PED
PED
Oct 29, 2013
Mar 30, 2014
Oct 29, 2017
Apr 29, 2014
Sep 30, 2014
Apr 29, 2018
EVEROLIMUS - AFINITOR DISPERZ
N 203985 003 5665772
6004973
7297703
Sep 09, 2019
Jul 12, 2016
Dec 06, 2019
DS DP
DP
DP
I-630
NCE
ODE
PED
PED
PED
Oct 29, 2013
Mar 30, 2014
Oct 29, 2017
Apr 29, 2014
Apr 29, 2018
Sep 30, 2014
EXENATIDE SYNTHETIC - BYETTA
N 021773 001 5424286
5424286
6858576
6872700
6902744
6956026
7297761
7521423
7741269
Dec 01, 2016
Dec 01, 2016
Jan 06, 2017
Jan 14, 2020
Jan 14, 2020
Jan 07, 2018
Oct 15, 2017
Oct 15, 2017
Jan 07, 2018
U-653
U-1108
U-656
U-654
DP
U-687
DP
DP
U-1074
M-111
M-113
Oct 19, 2014
Oct 19, 2014
EXENATIDE SYNTHETIC - BYETTA
N 021773 002 5424286
5424286
6858576
6872700
6902744
6956026
7297761
7521423
7741269
Dec 01, 2016
Dec 01, 2016
Jan 06, 2017
Jan 14, 2020
Jan 14, 2020
Jan 07, 2018
Oct 15, 2017
Oct 15, 2017
Jan 07, 2018
U-653
U-1108
U-656
U-654
DP
U-687
DP
DP
U-1074
M-111
M-113
Oct 19, 2014
Oct 19, 2014
EXENATIDE SYNTHETIC - BYDUREON
N 022200 001 5424286
6479065
6495164
6667061
6824822
6858576
6872700
6956026
7223440
7456254
7563871
7612176
7741269
8329648
8431685
8461105
Dec 01, 2016
Aug 10, 2020
May 25, 2020
May 25, 2020
Oct 09, 2022
Jan 06, 2017
Jan 14, 2020
Jan 07, 2018
Aug 31, 2021
Jun 30, 2025
Apr 15, 2024
Apr 13, 2025
Jan 07, 2018
Aug 18, 2026
Apr 13, 2025
Apr 13, 2025
U-1108
DP
DP
DP
DP
U-656
U-654
U-687
DP
DP U-1223
DP
DP U-1223
U-1224
U-1313
DP U-412
DP U-412
NP Jan 27, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 74 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
EZETIMIBE - ZETIA
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021445 001 5846966
5846966
5846966
7030106
7612058
7612058
RE37721
RE42461
RE42461
Sep 21, 2013
Sep 21, 2013
Sep 21, 2013
Jan 25, 2022
Jan 25, 2022
Jan 25, 2022
Oct 25, 2016
Oct 25, 2016
Oct 25, 2016
U-473
U-474
U-1172
DP
U-1027
U-1173
DS DP U-473
DS DP U-473
DS DP U-1173
M-109 Jan 24, 2015
EZETIMIBE; SIMVASTATIN - VYTORIN
N 021687 001 5846966 Sep 21, 2013
5846966 Sep 21, 2013
RE37721 Oct 25, 2016
RE42461 Oct 25, 2016
DP U-473
DP U-593
DS DP U-473
DS DP U-473
M-109 Jan 24, 2015
EZETIMIBE; SIMVASTATIN - VYTORIN
N 021687 002 5846966 Sep 21, 2013
5846966 Sep 21, 2013
RE37721 Oct 25, 2016
RE42461 Oct 25, 2016
DP U-473
DP U-593
DS DP U-473
DS DP U-473
M-109 Jan 24, 2015
EZETIMIBE; SIMVASTATIN - VYTORIN
N 021687 003 5846966 Sep 21, 2013
5846966 Sep 21, 2013
RE37721 Oct 25, 2016
RE42461 Oct 25, 2016
DP U-473
DP U-593
DS DP U-473
DS DP U-473
M-109 Jan 24, 2015
EZETIMIBE; SIMVASTATIN - VYTORIN
N 021687 004 5846966 Sep 21, 2013
5846966 Sep 21, 2013
RE37721 Oct 25, 2016
RE42461 Oct 25, 2016
DP U-473
DP U-593
DS DP U-473
DS DP U-473
M-109 Jan 24, 2015
EZOGABINE - POTIGA
N 022345 001 NCE Jun 10, 2016
EZOGABINE - POTIGA
N 022345 002 NCE Jun 10, 2016
EZOGABINE - POTIGA
N 022345 003 NCE Jun 10, 2016
EZOGABINE - POTIGA
N 022345 004 NCE Jun 10, 2016
FAMCICLOVIR - FAMVIR
N 020363 001 5840763
5866581
5916893
6124304
Sep 01, 2015
Oct 04, 2014
Sep 01, 2015
Oct 04, 2014
U-96
U-96
U-96
U-96
M-112
M-98
Feb 09, 2015
Jan 31, 2014
FAMCICLOVIR - FAMVIR
N 020363 002 5840763
5866581
5916893
6124304
Sep 01, 2015
Oct 04, 2014
Sep 01, 2015
Oct 04, 2014
U-96
U-96
U-96
U-96
M-112
M-98
Feb 09, 2015
Jan 31, 2014
FAMCICLOVIR - FAMVIR
N 020363 003 5840763
5866581
5916893
6124304
Sep 01, 2015
Oct 04, 2014
Sep 01, 2015
Oct 04, 2014
U-96
U-96
U-96
U-96
M-112
M-98
Feb 09, 2015
Jan 31, 2014
FAMOTIDINE - PEPCID AC
N 020325 001 5854267 Dec 29, 2015 U-267
FAMOTIDINE - PEPCID AC
N 020801 001 5667794
5854267
May 02, 2015
Dec 29, 2015 U-267
Y
FAMOTIDINE - PEPCID AC
N 020801 002 6814978 Aug 26, 2021 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 75 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
FAMOTIDINE - PEPCID AC
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 020902 001 5854267 Dec 29, 2015 U-368
FAMOTIDINE - FLUXID
N 021712 001 6024981
6221392
FAMOTIDINE - FLUXID
Apr 09, 2018
Apr 09, 2018
DP
DP
N 021712 002 6024981
6221392
Apr 09, 2018
Apr 09, 2018
DP
DP
FAMOTIDINE; IBUPROFEN - DUEXIS
N 022519 001 8067033
8067451
8309127
8318202
8449910
8501228
Jul 18, 2026
Jul 18, 2026
Jul 18, 2026
Jul 18, 2026
Jul 18, 2026
Jul 18, 2026
DP
DP U-1196
DP
DP
DP
U-1196
NC Apr 23, 2014
FEBUXOSTAT - ULORIC
N 021856 001 5614520
6225474
7361676
8372872
FEBUXOSTAT - ULORIC
Mar 25, 2019
Jun 18, 2019
Mar 08, 2024
Sep 08, 2031
DS DP U-954
DS
DP
U-1346
NCE Feb 13, 2014
N 021856 002 5614520
6225474
7361676
8372872
Mar 25, 2019
Jun 18, 2019
Mar 08, 2024
Sep 08, 2031
DS DP U-954
DS
DP
U-1346
NCE Feb 13, 2014
FENOFIBRATE - TRICOR
N 021203 001 6074670
6277405
6589552
6652881
7037529
7041319
Jan 09, 2018
Jan 09, 2018
Jan 09, 2018
Jan 09, 2018
Jan 09, 2018
Jan 09, 2018
DP
DP
DP
FENOFIBRATE - TRICOR
N 021203 003 6074670
6277405
6589552
6652881
7037529
7041319
Jan 09, 2018
Jan 09, 2018
Jan 09, 2018
Jan 09, 2018
Jan 09, 2018
Jan 09, 2018
DP
DP
DP
FENOFIBRATE - TRIGLIDE
N 021350 001 6696084
FENOFIBRATE - TRIGLIDE
Sep 11, 2021 DS DP U-680
N 021350 002 6696084 Sep 11, 2021 DS DP U-680
FENOFIBRATE - LIPOFEN
N 021612 001 5545628 Jan 10, 2015 DP U-701
FENOFIBRATE - LIPOFEN
N 021612 002 5545628 Jan 10, 2015 DP U-701
FENOFIBRATE - LIPOFEN
N 021612 003 5545628 Jan 10, 2015 DP U-701
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 76 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FENOFIBRATE - TRICOR
N 021656 001 6277405 Jan 09, 2018 DS
6375986 Sep 21, 2020 DP U-615
6652881 Jan 09, 2018 DS
7037529 Jan 09, 2018 DP
7041319 Jan 09, 2018 DP
7276249 Feb 21, 2023 DP
7320802 Feb 21, 2023 U-847
FENOFIBRATE - TRICOR
N 021656 002 6277405 Jan 09, 2018 DS
6375986 Sep 21, 2020 DP U-615
6652881 Jan 09, 2018 DS
7037529 Jan 09, 2018 DP
7041319 Jan 09, 2018 DP
7276249 Feb 21, 2023 DP
7320802 Feb 21, 2023 U-847
FENOFIBRATE - ANTARA (MICRONIZED)
N 021695 001 7101574 Aug 20, 2020 DS DP
7863331 Aug 08, 2020 U-1106
7863331 Aug 08, 2020 U-1107
FENOFIBRATE - ANTARA (MICRONIZED)
N 021695 003 7101574 Aug 20, 2020 DS DP
7863331 Aug 08, 2020 U-1106
7863331 Aug 08, 2020 U-1107
FENOFIBRATE - ANTARA (MICRONIZED)
N 021695 004 8026281 Apr 22, 2025 U-1447
8026281 Apr 22, 2025 U-1448
FENOFIBRATE - ANTARA (MICRONIZED)
N 021695 005 8026281 Apr 22, 2025 U-1447
8026281 Apr 22, 2025 U-1448
FENOFIBRATE - FENOGLIDE
N 022118 001 7658944 Dec 09, 2024 DP
8124125 Oct 01, 2024 DP U-1234
8481078 Oct 01, 2024 DP U-1416
FENOFIBRATE - FENOGLIDE
N 022118 002 7658944 Dec 09, 2024 DP
8124125 Oct 01, 2024 DP U-1234
8481078 Oct 01, 2024 DP U-1416
FENOFIBRIC ACID - FIBRICOR
N 022418 001 7569612 Aug 20, 2027 U-1000
7741373 Aug 20, 2027 U-1059
7741374 Aug 20, 2027 U-1060
7741374 Aug 20, 2027 U-1061
7915247 Aug 20, 2027 U-1000
7915247 Aug 20, 2027 U-1059
7915247 Aug 20, 2027 U-1061
FENOFIBRIC ACID - FIBRICOR
N 022418 002 7569612 Aug 20, 2027 U-1000
7741373 Aug 20, 2027 U-1059
7741374 Aug 20, 2027 U-1060
7741374 Aug 20, 2027 U-1061
7915247 Aug 20, 2027 U-1000
7915247 Aug 20, 2027 U-1059
7915247 Aug 20, 2027 U-1061
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 77 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
FENTANYL - SUBSYS
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 202788 001 8486972
8486973
FENTANYL - SUBSYS
Apr 26, 2029
Apr 26, 2029
DP
U-55
NP Jan 04, 2015
N 202788 002 8486972
8486973
FENTANYL - SUBSYS
Apr 26, 2029
Apr 26, 2029
DP
U-55
NP Jan 04, 2015
N 202788 003 8486972
8486973
FENTANYL - SUBSYS
Apr 26, 2029
Apr 26, 2029
DP
U-55
NP Jan 04, 2015
N 202788 004 8486972
8486973
FENTANYL - SUBSYS
Apr 26, 2029
Apr 26, 2029
DP
U-55
NP Jan 04, 2015
N 202788 005 8486972
8486973
FENTANYL - SUBSYS
Apr 26, 2029
Apr 26, 2029
DP
U-55
NP Jan 04, 2015
N 202788 006 8486972
8486973
FENTANYL - SUBSYS
Apr 26, 2029
Apr 26, 2029
DP
U-55
NP Jan 04, 2015
N 202788 007 8486972
8486973
Apr 26, 2029
Apr 26, 2029
DP
U-55
NP Jan 04, 2015
FENTANYL CITRATE - FENTORA
N 021947 001 6200604
6974590
7862832
7862833
8092832
Mar 26, 2019
Mar 26, 2019
Jun 15, 2028
Jun 15, 2028
Dec 30, 2024
U-767
U-767
DP
DP
DP
FENTANYL CITRATE - FENTORA
N 021947 002 6200604
6974590
7862832
7862833
8092832
8119158
Mar 26, 2019
Mar 26, 2019
Jun 15, 2028
Jun 15, 2028
Dec 30, 2024
Dec 30, 2024
U-767
U-767
DP
DP
DP
DP
FENTANYL CITRATE - FENTORA
N 021947 003 6200604
6974590
7862832
7862833
8092832
8119158
Mar 26, 2019
Mar 26, 2019
Jun 15, 2028
Jun 15, 2028
Dec 30, 2024
Dec 30, 2024
U-767
U-767
DP
DP
DP
DP
FENTANYL CITRATE - FENTORA
N 021947 004 6200604
6974590
7862832
7862833
8092832
8119158
Mar 26, 2019
Mar 26, 2019
Jun 15, 2028
Jun 15, 2028
Dec 30, 2024
Dec 30, 2024
U-767
U-767
DP
DP
DP
DP
FENTANYL CITRATE - FENTORA
N 021947 005 6200604
6974590
7862832
7862833
8092832
8119158
Mar 26, 2019
Mar 26, 2019
Jun 15, 2028
Jun 15, 2028
Dec 30, 2024
Dec 30, 2024
U-767
U-767
DP
DP
DP
DP
FENTANYL CITRATE - FENTORA
N 021947 006 6200604
6974590
Mar 26, 2019
Mar 26, 2019
U-767
U-767
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 78 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FENTANYL CITRATE - ONSOLIS
N 022266 001 6159498 Oct 18, 2016 DP
7579019 Jan 22, 2020 U-767
FENTANYL CITRATE - ONSOLIS
N 022266 002 6159498 Oct 18, 2016 DP
7579019 Jan 22, 2020 U-767
FENTANYL CITRATE - ONSOLIS
N 022266 003 6159498 Oct 18, 2016 DP
7579019 Jan 22, 2020 U-767
FENTANYL CITRATE - ONSOLIS
N 022266 004 6159498 Oct 18, 2016 DP
7579019 Jan 22, 2020 U-767
FENTANYL CITRATE - ONSOLIS
N 022266 005 6159498 Oct 18, 2016 DP
7579019 Jan 22, 2020 U-767
FENTANYL CITRATE - ABSTRAL
N 022510 001 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - ABSTRAL
N 022510 002 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - ABSTRAL
N 022510 003 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - ABSTRAL
N 022510 004 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - ABSTRAL
N 022510 005 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - ABSTRAL
N 022510 006 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - LAZANDA
N 022569 001 6432440 Apr 20, 2018 DP U-1169 NDF Jun 30, 2014
8216604 Oct 03, 2024 U-767
FENTANYL CITRATE - LAZANDA
N 022569 002 6432440 Apr 20, 2018 DP U-1169 NDF Jun 30, 2014
8216604 Oct 03, 2024 U-767
FENTANYL HYDROCHLORIDE - IONSYS
N 021338 001 5697896 Dec 16, 2014 DP
5843014 Dec 01, 2015 DP
6169920 Jan 02, 2018 DP
6171294 Jun 05, 2015 U-736
6181963 Nov 02, 2019 DP
6195582 Jan 28, 2019 DP U-736
6216033 Jun 05, 2015 DP
6425892 Jun 05, 2015 U-736
6842640 Jun 02, 2015 DP
6881208 Apr 19, 2022 U-736
6975902 Apr 01, 2024 DP
7018370 Jun 05, 2015 U-736
7027859 Sep 26, 2014 DP
7302293 Jun 05, 2015 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 79 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FERRIC CARBOXYMALTOSE - INJECTAFER
N 203565 001 7612109 Feb 05, 2024 DS DP NP Jul 25, 2016
7754702 Feb 13, 2027 DP U-1432
FERUMOXYTOL - FERAHEME
N 022180 001 6599498 Mar 08, 2020 DS DP
7553479 Mar 08, 2020 DS DP
7871597 Mar 08, 2020 DS DP
8501158 Mar 08, 2020 U-1422
8591864 Mar 08, 2020 DP
FESOTERODINE FUMARATE - TOVIAZ
N 022030 001 6858650 Jul 03, 2022 DS U-913 NCE Oct 31, 2013
7384980 May 11, 2019 DS DP U-913
7807715 Jun 07, 2027 DP U-913
7855230 May 11, 2019 U-913
7985772 May 11, 2019 DS DP U-913
8088398 Jun 07, 2027 DP U-913
8338478 May 11, 2019 DS DP U-913
8501723 Jun 07, 2027 DP
FESOTERODINE FUMARATE - TOVIAZ
N 022030 002 6858650 Jul 03, 2022 DS U-913 NCE Oct 31, 2013
7384980 May 11, 2019 DS DP U-913
7807715 Jun 07, 2027 DP U-913
7855230 May 11, 2019 U-913
7985772 May 11, 2019 DS DP U-913
8088398 Jun 07, 2027 DP U-913
8338478 May 11, 2019 DS DP U-913
8501723 Jun 07, 2027 DP
FEXOFENADINE HYDROCHLORIDE - ALLEGRA
N 020625 001 5578610 Nov 26, 2013 U-192
5738872 Feb 28, 2015
5855912 Feb 28, 2015
5932247 Feb 28, 2015
6037353 Mar 14, 2017 U-138
6113942 Feb 28, 2015
7135571 May 18, 2014 DS
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY
N 020872 005 5578610 Nov 26, 2013 DS DP U-1160
5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
7135571 May 18, 2014 DS U-1160
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES
N 020872 006 5578610 Nov 26, 2013 DS DP U-1160
5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
7135571 May 18, 2014 DS U-1160
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE - ALLEGRA ALLERGY
N 020872 007 5578610 Nov 26, 2013 DS DP U-1160
5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
7135571 May 18, 2014 DS U-1160
7138524 May 18, 2014 DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 80 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FEXOFENADINE HYDROCHLORIDE - ALLEGRA HIVES
N 020872 008 5578610 Nov 26, 2013 DS DP U-1160
5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
7135571 May 18, 2014 DS U-1160
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE - ALLEGRA HIVES
N 020872 009 5578610 Nov 26, 2013 DS DP U-1160
5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
7135571 May 18, 2014 DS U-1160
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE - ALLEGRA ALLERGY
N 020872 010 5578610 Nov 26, 2013 DS DP U-1160
5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
7135571 May 18, 2014 DS U-1160
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY
N 021909 002 5578610 Nov 26, 2013 DS DP U-1158
5738872 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1158
6037353 Mar 14, 2017 U-1466
6723348 Nov 26, 2021 DP U-1466
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES
N 021909 003 5578610 Nov 26, 2013 DS DP U-1158
5738872 Feb 28, 2015 DP
6037353 Mar 14, 2017
6723348 Nov 26, 2021 DP
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE - ALLEGRA
N 021963 001 5578610 Nov 26, 2013 DS DP U-772
6037353 Mar 14, 2017 U-772
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY
N 201373 001 5578610 Nov 26, 2013 DS DP U-1157
6037353 Mar 14, 2017 U-1157
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES
N 201373 002 5578610 Nov 26, 2013 DS DP U-1157
6037353 Mar 14, 2017 U-1157
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
N 020786 002 5578610 Nov 26, 2013 DS DP U-1159
5855912 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1159
6039974 Jul 31, 2018 DP
6113942 Feb 28, 2015 DP
7135571 May 18, 2014 DS U-1159
7138524 May 18, 2014 DS
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
N 021704 002 5578610 Nov 26, 2013 DS DP U-1159
6037353 Mar 14, 2017 U-1159
6613357 Dec 25, 2020 DP U-1159
7138524 May 18, 2014 DS
RE39069 May 29, 2018 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 81 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FIDAXOMICIN - DIFICID
N 201699 001 7378508
7863249
7906489
8586551
Jul 31, 2027
Jul 31, 2027
Mar 04, 2027
Apr 12, 2024
DS DP
DS DP
U-319
DS DP
NCE May 27, 2016
FINASTERIDE - FINASTERIDE
A 076436 001 PC Jul 01, 2013
FINASTERIDE - PROSCAR
N 020180 001 5942519 Oct 23, 2018 U-280
FINASTERIDE - PROPECIA
N 020788 001 5547957
5571817
Oct 15, 2013
Nov 05, 2013
U-236
U-259
FINGOLIMOD - GILENYA
N 022527 001 5604229
6004565
8324283
Feb 18, 2014
Sep 23, 2017
Mar 29, 2026
DS U-1086
U-1086
M-106
NCE
Jul 20, 2014
Sep 21, 2015
FLORBETAPIR F-18 - AMYVID
N 202008 001 7687052
8506929
Apr 30, 2027
Apr 30, 2027
DS DP
DS DP U-1423
NCE Apr 06, 2017
FLORBETAPIR F-18 - AMYVID
N 202008 002 7687052
8506929
Apr 30, 2027
Apr 30, 2027
DS DP
DS DP U-1423
NCE Apr 06, 2017
FLORBETAPIR F-18 - AMYVID
N 202008 003 7687052
8506929
Apr 30, 2027
Apr 30, 2027
DS DP
DS DP U-1423
NCE Apr 06, 2017
FLUDARABINE PHOSPHATE - OFORTA
N 022273 001 7148207
7547776
Dec 20, 2022
Dec 10, 2018
DP U-944
DS
ODE Dec 18, 2015
FLUNISOLIDE - AEROSPAN HFA
N 021247 001 5776433
5980867
Jul 07, 2015
Dec 20, 2013
DP
DP
M-128 Aug 28, 2016
FLUOCINOLONE ACETONIDE - RETISERT
N 021737 001 6217895
6548078
Mar 22, 2019
Mar 22, 2019
DP U-708
DP U-708
FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN - TRI-LUMA
N 021112 001 7915243
7939516
8247395
Mar 22, 2026
May 04, 2025
Oct 22, 2022
DP
DP
DP
FLUOCINONIDE - VANOS
N 021758 001 6765001
7220424
7794738
8232264
Dec 21, 2021
Jan 07, 2023
Sep 11, 2022
Mar 09, 2023
DP
U-861
U-1084
DP
FLUOROURACIL - CARAC
N 020985 001 6670335 Jun 02, 2021 DP U-68
FLUOXETINE HYDROCHLORIDE - PROZAC
N 018936 001 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE - PROZAC
N 018936 003 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE - PROZAC
N 018936 004 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE - PROZAC
N 018936 006 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE - PROZAC WEEKLY
N 021235 001 5910319
5985322
RE39030
RE39030
May 29, 2017
May 29, 2017
May 29, 2017
May 29, 2017
U-396
U-397
DP U-396
DP U-397
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 82 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N 021520 001 6960577 Nov 01, 2017 U-962 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N 021520 002 5945416 Mar 24, 2017
6960577 Nov 01, 2017
DS DP
U-962
Y NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N 021520 003 5945416 Mar 24, 2017
6960577 Nov 01, 2017
DS DP
U-962
Y NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N 021520 004 5945416 Mar 24, 2017
6960577 Nov 01, 2017
DS DP
U-962
Y NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N 021520 005 5945416 Mar 24, 2017
6960577 Nov 01, 2017
DS DP
U-962
Y NPP Jul 26, 2016
FLUTEMETAMOL F-18 - VIZAMYL
N 203137 001 8236282
FLUTEMETAMOL F-18 - VIZAMYL
May 21, 2024 DS DP
N 203137 002 8236282
FLUTICASONE FUROATE - VERAMYST
May 21, 2024 DS DP
N 022051 001 6858596
7101866
7541350
8062264
8147461
8347879
Aug 03, 2021
Aug 03, 2021
Aug 03, 2021
Apr 05, 2026
Mar 10, 2025
Apr 01, 2027
DP U-808
DS DP U-808
DP U-988
DP
DP
DP
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - BREO ELLIPTA
N 204275 001 5873360 Feb 23, 2016 DP
6537983 Aug 03, 2021 DP U-1401
6759398 Aug 03, 2021 DP U-1401
6878698 Aug 03, 2021 U-1401
7101866 Aug 03, 2021 DS DP U-1401
7361787 Mar 23, 2023 DS DP U-1401
7439393 Sep 11, 2022 DS DP U-1401
7629335 Aug 03, 2021 DP
7776895 Sep 11, 2022 DP
8113199 Oct 23, 2027 DP
8161968 Feb 05, 2028 DP
8511304 Nov 11, 2025 DP U-1424
8534281 Aug 10, 2029 DP
FLUTICASONE PROPIONATE - FLOVENT DISKUS 50
N 020833 001 5873360 Feb 23, 2016 DP
FLUTICASONE PROPIONATE - FLOVENT DISKUS 100
N 020833 002 5873360 Feb 23, 2016 DP
FLUTICASONE PROPIONATE - FLOVENT DISKUS 250
N 020833 003 5873360 Feb 23, 2016 DP
FLUTICASONE PROPIONATE - CUTIVATE
N 021152 001 7300669 Oct 20, 2019 DP U-835
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 83 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FLUTICASONE PROPIONATE - FLOVENT HFA
N 021433 001 5658549 Aug 19, 2014 DP U-710
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017 DP
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-581
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2018
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Jan 04, 2025 DP
7832351 Jun 19, 2023 DP
FLUTICASONE PROPIONATE - FLOVENT HFA
N 021433 002 5658549 Aug 19, 2014 DP U-710
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017 DP
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-581
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2018
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Jan 04, 2025 DP
7832351 Jun 19, 2023 DP
FLUTICASONE PROPIONATE - FLOVENT HFA
N 021433 003 5658549 Aug 19, 2014 DP U-710
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017 DP
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-581
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2018
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Jan 04, 2025 DP
7832351 Jun 19, 2023 DP
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 100/50
N 021077 001 5873360 Feb 23, 2016 DP
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 250/50
N 021077 002 5873360 Feb 23, 2016 DP
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 500/50
N 021077 003 5873360 Feb 23, 2016 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 84 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA
N 021254 001 5658549 Aug 19, 2014 DP U-738
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-841
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Jan 04, 2025 DP
7832351 Jun 19, 2023 DP
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA
N 021254 002 5658549 Aug 19, 2014 DP U-738
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017 DP
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-841
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Jan 04, 2025 DP
7832351 Jun 19, 2023 DP
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA
N 021254 003 5658549 Aug 19, 2014 DP U-738
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017 DP
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-841
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Jan 04, 2025 DP
7832351 Jun 19, 2023 DP
FLUVASTATIN SODIUM - LESCOL XL
N 021192 001 6242003 Apr 13, 2020
FLUVOXAMINE MALEATE - FLUVOXAMINE MALEATE
A 091476 002 PC Sep 09, 2013
FLUVOXAMINE MALEATE - LUVOX CR
N 022033 001 7465462 May 10, 2020 DP U-929
FLUVOXAMINE MALEATE - LUVOX CR
N 022033 002 7465462 May 10, 2020 DP U-929
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 85 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FOLLITROPIN ALFA/BETA - GONAL-F
N 020378 001 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F
N 020378 002 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F
N 020378 003 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F
N 020378 004 5767067
5767251
7563763
Jun 16, 2015
Jun 16, 2015
Aug 23, 2019
DS
DS
DP
FOLLITROPIN ALFA/BETA - GONAL-F
N 020378 005 5767067
5767251
7563763
Jun 16, 2015
Jun 16, 2015
Aug 23, 2019
DS
DS
DP
FOLLITROPIN ALFA/BETA - FOLLISTIM
N 020582 001 5767251 Jun 16, 2015
FOLLITROPIN ALFA/BETA - FOLLISTIM
N 020582 002 5767251 Jun 16, 2015
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021211 001 5767251
5929028
5929028
7446090
7563763
7563763
7563763
Jun 16, 2015
Jan 14, 2018
Jan 14, 2018
Aug 23, 2019
Aug 23, 2019
Aug 23, 2019
Aug 23, 2019
DS
DP U-567
DP U-1366
DP
U-993
U-1183
U-1367
D-133 Aug 22, 2014
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021211 002 5767251
5929028
5929028
7446090
7563763
7563763
7563763
Jun 16, 2015
Jan 14, 2018
Jan 14, 2018
Aug 23, 2019
Aug 23, 2019
Aug 23, 2019
Aug 23, 2019
DS
DP U-567
DP U-1366
DP
U-993
U-1183
U-1367
D-133 Aug 22, 2014
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021211 003 5767251
5929028
5929028
7446090
7563763
7563763
7563763
Jun 16, 2015
Jan 14, 2018
Jan 14, 2018
Aug 23, 2019
Aug 23, 2019
Aug 23, 2019
Aug 23, 2019
DS
DP U-567
DP U-1366
DP
U-993
U-1183
U-1367
D-133 Aug 22, 2014
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021211 004 5767251
5929028
5929028
7446090
7563763
7563763
7563763
Jun 16, 2015
Jan 14, 2018
Jan 14, 2018
Aug 23, 2019
Aug 23, 2019
Aug 23, 2019
Aug 23, 2019
DS
DP U-567
DP U-1366
DP
U-993
U-1183
U-1367
D-133 Aug 22, 2014
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021273 001 5767251
5929028
Jun 16, 2015
Jan 14, 2018
DS
DP U-1366
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021273 002 5767251
5929028
Jun 16, 2015
Jan 14, 2018
DS
DP U-1366
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 86 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FOLLITROPIN ALFA/BETA - GONAL-F RFF PEN
N 021684 001 5767067 Jun 16, 2015
5767251 Jun 16, 2015
7446090 Aug 23, 2019
7741268 Apr 02, 2024
FOLLITROPIN ALFA/BETA - GONAL-F RFF PEN
N 021684 002 5767067 Jun 16, 2015
5767251 Jun 16, 2015
7446090 Aug 23, 2019
7741268 Apr 02, 2024
FOLLITROPIN ALFA/BETA - GONAL-F RFF PEN
N 021684 003 5767067 Jun 16, 2015
5767251 Jun 16, 2015
7446090 Aug 23, 2019
7741268 Apr 02, 2024
FOLLITROPIN ALFA/BETA - GONAL-F
N 021765 001 5767251 Jun 16, 2015
FOLLITROPIN ALFA/BETA - GONAL-F RFF
N 021765 002 5767067 Jun 16, 2015
5767251 Jun 16, 2015
FOLLITROPIN ALFA/BETA - GONAL-F
N 021765 003 5767251 Jun 16, 2015
FOMEPIZOLE - ANTIZOL
DS
DS
DP
DP
DS
DS
DP
DP
DS
DS
DP
DP
DS
DS
DS
DS
N 020696 001 7553863
FORMOTEROL FUMARATE - FORADIL
Jun 30, 2027 DS DP
N 020831 001 6488027 Mar 08, 2019
6887459 Nov 28, 2020
FORMOTEROL FUMARATE - PERFOROMIST
U-762
N 022007 001 6667344 Jun 22, 2021
6814953 Jun 22, 2021
7348362 Jun 22, 2021
7462645 Jun 22, 2021
FORMOTEROL FUMARATE; MOMETASONE FUROATE - DULERA
N 022518 001 5889015 Jan 27, 2014
6057307 Jan 27, 2014
6068832 Aug 27, 2017
6677323 Jan 27, 2014
7067502 May 21, 2020
7566705 May 21, 2020
FORMOTEROL FUMARATE; MOMETASONE FUROATE - DULERA
N 022518 002 5889015 Jan 27, 2014
6057307 Jan 27, 2014
6068832 Aug 27, 2017
6677323 Jan 27, 2014
7067502 May 21, 2020
7566705 May 21, 2020
FOSAMPRENAVIR CALCIUM - LEXIVA
DP
DP U-813
DP
DP U-813
U-1068
DP U-1068
DP U-1068
U-1068
DP U-1068
DP U-1068
U-1068
DP U-1068
DP U-1068
U-1068
DP U-1068
DP U-1068
N 021548 001 6436989
6514953
FOSAMPRENAVIR CALCIUM - LEXIVA
Dec 24, 2017
Jul 15, 2019
DS DP U-257
DS DP U-257
NPP
PED
Apr 27, 2015
Oct 27, 2015
N 022116 001 6436989 Dec 24, 2017 DS DP U-257 NPP
PED
Apr 27, 2015
Oct 27, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 87 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FOSAPREPITANT DIMEGLUMINE - EMEND
N 022023 001 5512570
5538982
5691336
5716942
Mar 04, 2014
Jul 23, 2013
Mar 04, 2019
Feb 10, 2015
U-850
U-850
DS DP
U-850
FOSAPREPITANT DIMEGLUMINE - EMEND
N 022023 002 5512570
5538982
5691336
5716942
Mar 04, 2014
Jul 23, 2013
Mar 04, 2019
Feb 10, 2015
U-850
U-850
DS DP
U-850
D-128 Nov 12, 2013
FOSPROPOFOL DISODIUM - LUSEDRA
N 022244 001 6204257
6872838
Jul 01, 2022
Aug 07, 2018
DS DP U-945
DS
NCE Dec 12, 2013
FROVATRIPTAN SUCCINATE - FROVA
N 021006 001 5464864
5616603
5637611
5827871
5962501
Nov 07, 2015
Apr 01, 2014
Jun 10, 2014
Oct 27, 2015
Dec 16, 2013
U-436
U-436
U-436
U-436
U-436
FULVESTRANT - FASLODEX
N 021344 001 6774122
7456160
8329680
8466139
8466139*PED
Jan 09, 2021
Jan 09, 2021
Jan 09, 2021
Jan 09, 2021
Jul 09, 2021
U-596
U-596
U-596
U-596
D-126
M-103
M-123
PED
PED
Sep 09, 2013
May 17, 2014
Nov 09, 2015
Mar 09, 2014
Nov 17, 2014
GABAPENTIN - NEURONTIN
N 020235 001 6054482
GABAPENTIN - NEURONTIN
Apr 25, 2017
N 020235 002 6054482
GABAPENTIN - NEURONTIN
Apr 25, 2017
N 020235 003 6054482
GABAPENTIN - NEURONTIN
Apr 25, 2017
N 020882 001 6054482
GABAPENTIN - NEURONTIN
Apr 25, 2017
N 020882 002 6054482
GABAPENTIN - NEURONTIN
Apr 25, 2017
N 021129 001 6054482
7256216
Apr 25, 2017
May 28, 2022 DP
GABAPENTIN - GRALISE
N 022544 001 6340475
6488962
6635280
6723340
7438927
7731989
8192756
8252332
8333992
Sep 19, 2016
Jun 20, 2020
Sep 19, 2016
Oct 25, 2021
Feb 26, 2024
Oct 25, 2022
Oct 25, 2022
Oct 25, 2022
Oct 25, 2022
DP
DP
DP
DP
U-1114
DP
DP U-1114
DP U-1114
DP U-1114
NP Jan 28, 2014
GABAPENTIN - GRALISE
N 022544 002 6340475
6488962
6635280
6723340
7438927
7731989
8192756
8252332
8333992
Sep 19, 2016
Jun 20, 2020
Sep 19, 2016
Oct 25, 2021
Feb 26, 2024
Oct 25, 2022
Oct 25, 2022
Oct 25, 2022
Oct 25, 2022
DP
DP
DP
DP
U-1114
DP
DP U-1114
DP U-1114
DP U-1114
NP Jan 28, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 88 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PATENT
EXPIRATION PATENT
PATENT
DELIST EXCLUSIVITY
EXCLUSIVITY
EXPIRATION
GABAPENTIN ENACARBIL - HORIZANT
DATE CODES REQUESTED CODE(S) DATE
N 022399 001 6818787
8026279
8048917
8114909
Nov 06, 2022
Nov 10, 2026
Nov 06, 2022
Apr 11, 2026
DS DP
DS DP
DS DP U-1247
U-1231
I-652
NCE
Jun 06, 2015
Apr 06, 2016
GABAPENTIN ENACARBIL - HORIZANT
N 022399 002 6818787
8026279
8048917
8114909
Nov 06, 2022
Nov 10, 2026
Nov 06, 2022
Apr 11, 2026
DS DP
DS DP
DS DP U-1247
U-1231
I-652
NCE
Jun 06, 2015
Apr 06, 2016
GADOBENATE DIMEGLUMINE - MULTIHANCE
N 021357 001 I-654 Jul 06, 2015
GADOBENATE DIMEGLUMINE - MULTIHANCE
N 021357 002 I-654 Jul 06, 2015
GADOBENATE DIMEGLUMINE - MULTIHANCE
N 021357 003 I-654 Jul 06, 2015
GADOBENATE DIMEGLUMINE - MULTIHANCE
N 021357 004 I-654 Jul 06, 2015
GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK
N 021358 001 I-654 Jul 06, 2015
GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK
N 021358 002 I-654 Jul 06, 2015
GADOBUTROL - GADAVIST
N 201277 001 5980864 Nov 09, 2016 DS DP U-1119 NCE Mar 14, 2016
GADOBUTROL - GADAVIST
N 201277 002 5980864 Nov 09, 2016 DS DP U-1119 NCE Mar 14, 2016
GADOBUTROL - GADAVIST
N 201277 003 5980864 Nov 09, 2016 DS DP U-1119 NCE Mar 14, 2016
GADOBUTROL - GADAVIST
N 201277 004 5980864 Nov 09, 2016 DS DP U-1119 NCE Mar 14, 2016
GADOBUTROL - GADAVIST
N 201277 005 5980864 Nov 09, 2016 DS DP U-1119 NCE Mar 14, 2016
GADODIAMIDE - OMNISCAN
N 020123 001 5560903 Oct 01, 2013 DP
GADODIAMIDE - OMNISCAN
N 022066 001 5560903 Oct 01, 2013 DP
GADODIAMIDE - OMNISCAN
N 022066 002 5560903 Oct 01, 2013 DP
GADOFOSVESET TRISODIUM - ABLAVAR
N 021711 001 6676929
7011815
7060250
7229606
8017105
8394356
May 04, 2020
Feb 01, 2015
May 26, 2015
May 26, 2015
May 26, 2015
Feb 01, 2015
DP
U-1112
DS
U-1112
DS
U-1112
NCE Dec 22, 2013
GADOFOSVESET TRISODIUM - ABLAVAR
N 021711 002 6676929
7011815
7060250
7229606
8017105
8394356
May 04, 2020
Feb 01, 2015
May 26, 2015
May 26, 2015
May 26, 2015
Feb 01, 2015
DP
U-1112
DS
U-1112
DS
U-1112
NCE Dec 22, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 89 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PATENT
EXPIRATION PATENT
PATENT
DELIST EXCLUSIVITY
EXCLUSIVITY
EXPIRATION
GADOTERATE MEGLUMINE - DOTAREM
DATE CODES REQUESTED CODE(S) DATE
N 204781 001 NCE Mar 20, 2018
GADOTERATE MEGLUMINE - DOTAREM
N 204781 002 NCE Mar 20, 2018
GADOTERATE MEGLUMINE - DOTAREM
N 204781 003 NCE Mar 20, 2018
GADOTERATE MEGLUMINE - DOTAREM
N 204781 004 NCE Mar 20, 2018
GADOTERIDOL - PROHANCE
N 020131 001 5846519 Dec 08, 2015
GADOTERIDOL - PROHANCE MULTIPACK
N 021489 001 5846519 Dec 08, 2015
GADOXETATE DISODIUM - EOVIST
N 022090 001 5798092
6039931
Aug 25, 2015
Nov 13, 2021
DS DP
U-1239
NCE Jul 03, 2013
GADOXETATE DISODIUM - EOVIST
N 022090 002 NCE Jul 03, 2013
GALANTAMINE HYDROBROMIDE - RAZADYNE
N 021169 001 6099863
6358527
Jun 06, 2017
Jun 06, 2017 DP U-322
GALANTAMINE HYDROBROMIDE - RAZADYNE
N 021169 002 6099863
6358527
Jun 06, 2017
Jun 06, 2017 DP U-322
GALANTAMINE HYDROBROMIDE - RAZADYNE
N 021169 003 6099863
6358527
Jun 06, 2017
Jun 06, 2017 DP U-322
GALANTAMINE HYDROBROMIDE - RAZADYNE ER
N 021615 001 7160559 Dec 20, 2019 DP
GALANTAMINE HYDROBROMIDE - RAZADYNE ER
N 021615 002 7160559 Dec 20, 2019 DP
GALANTAMINE HYDROBROMIDE - RAZADYNE ER
N 021615 003 7160559 Dec 20, 2019 DP
GANCICLOVIR - ZIRGAN
N 022211 001 ODE Sep 15, 2016
GANIRELIX ACETATE - GANIRELIX ACETATE
N 021057 001 5767082
6653286
Jun 16, 2015
Jun 16, 2018 U-1354
GATIFLOXACIN - GATIFLOXACIN
A 202653 001 PC Mar 30, 2014
GATIFLOXACIN - ZYMAR
N 021493 001 5880283
6333045
Dec 05, 2015
Aug 20, 2019 DP
GATIFLOXACIN - ZYMAXID
N 022548 001 5880283
6333045
Dec 05, 2015
Aug 20, 2019
DS
DS DP
GEFITINIB - IRESSA
N 021399 001 5770599 May 05, 2017 DS DP U-881
GEMIFLOXACIN MESYLATE - FACTIVE
N 021158 001 5633262
5776944
5962468
6262071
6331550
6340689
6455540
6723734
6803376
6803376
Jun 15, 2015
Apr 04, 2017
Jun 15, 2015
Sep 21, 2019
Sep 21, 2019
Sep 14, 2019
Sep 21, 2019
Mar 20, 2018
Sep 21, 2019
Sep 21, 2019
DS DP
U-282
U-513
U-511
U-512
U-511
DS DP
DS DP U-608
DS DP U-609
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 90 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
GEMTUZUMAB OZOGAMICIN - MYLOTARG
N 021174 001 5585089 Dec 17, 2013
5606040 Feb 25, 2014
5693762 Dec 02, 2014
5739116 Apr 14, 2015
5767285 Jun 16, 2015
5773001 Jun 30, 2015 U-320
GLATIRAMER ACETATE - COPAXONE
N 020622 001 5981589 May 24, 2014
6054430 May 24, 2014
6342476 May 24, 2014 U-441
6362161 May 24, 2014 U-441
6620847 May 24, 2014 DS
6939539 May 24, 2014 DS
7199098 May 24, 2014 DS
GLATIRAMER ACETATE - COPAXONE
N 020622 002 5981589 May 24, 2014
6054430 May 24, 2014
6342476 May 24, 2014 U-441
6362161 May 24, 2014 U-441
6620847 May 24, 2014 DS
6939539 May 24, 2014 DS
7199098 May 24, 2014 DS
8367605 May 24, 2014 DS
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT
N 021925 001 6150383 Jun 19, 2016 U-753
6211205 Jun 19, 2016 U-753
6303640 Aug 09, 2016 U-753
6329404 Jun 19, 2016 DP U-753
7538125 Jun 19, 2016 DP
7700128 Jan 30, 2027 DP
8071130 Jun 08, 2028 DP
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT
N 021925 002 6150383 Jun 19, 2016 U-753
6211205 Jun 19, 2016 U-753
6303640 Aug 09, 2016 U-753
6329404 Jun 19, 2016 DP U-753
7538125 Jun 19, 2016 DP
7700128 Jan 30, 2027 DP
8071130 Jun 08, 2028 DP
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N 021700 001 5741803 Apr 21, 2015 DS DP U-690
5741803 Apr 21, 2015 DS DP U-781
7358366 Apr 19, 2020 DS
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N 021700 002 5741803 Apr 21, 2015 DS DP U-690
5741803 Apr 21, 2015 DS DP U-781
7358366 Apr 19, 2020 DS
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N 021700 003 5741803 Apr 21, 2015 DS DP U-690
5741803 Apr 21, 2015 DS DP U-781
7358366 Apr 19, 2020 DS
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N 021700 004 7358366 Apr 19, 2020 DS
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N 021700 005 7358366 Apr 19, 2020 DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 91 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
GLIPIZIDE - GLUCOTROL XL
N 020329 001 5591454 Jan 07, 2014
RE44459 Mar 26, 2019
U-150
U-1431
GLIPIZIDE - GLUCOTROL XL
N 020329 002 5591454 Jan 07, 2014
RE44459 Mar 26, 2019
U-150
U-1431
GLIPIZIDE - GLUCOTROL XL
N 020329 003 5591454 Jan 07, 2014
RE44459 Mar 26, 2019
U-111
U-1431
GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE
N 021178 001 6303146 Jul 14, 2019 U-412
GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE
N 021178 002 6303146 Jul 14, 2019 U-412
GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE
N 021178 003 6303146 Jul 14, 2019 U-412
GLYCEROL PHENYLBUTYRATE - RAVICTI
N 203284 001 5968979 Feb 07, 2015
8404215 Mar 09, 2032
DS DP U-1378
U-1383
NE
ODE
Feb 01, 2016
Feb 01, 2020
GLYCOPYRROLATE - ROBINUL
N 012827 001 7091236 Apr 24, 2024 U-877 Y
GLYCOPYRROLATE - ROBINUL FORTE
N 012827 002 7091236 Apr 24, 2024 U-877 Y
GLYCOPYRROLATE - CUVPOSA
N 022571 001 7638552 Aug 20, 2023
7816396 Aug 20, 2023
U-1076
U-1076
NP
ODE
Jul 28, 2013
Jul 28, 2017
GOSERELIN ACETATE - ZOLADEX
N 019726 001 7118552 Apr 13, 2022
7220247 Apr 09, 2022
7500964 Feb 26, 2021
DP
DP
DP
GOSERELIN ACETATE - ZOLADEX
N 020578 001 7118552 Apr 13, 2022
7220247 Apr 09, 2022
7500964 Feb 26, 2021
DP
DP
DP
GRANISETRON - SANCUSO
N 022198 001 7608282 Oct 22, 2024 DP U-1011
GRANISETRON HYDROCHLORIDE - KYTRIL
N 020239 001 5952340 Sep 14, 2016 U-519 M-102 Apr 29, 2014
GRANISETRON HYDROCHLORIDE - KYTRIL
N 020239 002 5952340 Sep 14, 2016 U-519 M-102 Apr 29, 2014
GRANISETRON HYDROCHLORIDE - KYTRIL
N 020239 003 M-102 Apr 29, 2014
GRANISETRON HYDROCHLORIDE - KYTRIL
N 020239 004 5952340 Sep 14, 2016 U-519 M-102 Apr 29, 2014
GREPAFLOXACIN HYDROCHLORIDE - RAXAR
N 020695 001 5563138 Oct 08, 2013
GUAIFENESIN - MUCINEX
N 021282 001 6372252 Apr 28, 2020
6955821 Apr 28, 2020
7838032 Apr 28, 2020
U-489
DP U-489
DP
GUAIFENESIN - MUCINEX
N 021282 002 6372252 Apr 28, 2020
6955821 Apr 28, 2020
7838032 Apr 28, 2020
U-489
DP U-489
DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 92 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D
N 021585 001 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-686
7838032 Apr 28, 2020 DP
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D
N 021585 002 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-686
7838032 Apr 28, 2020 DP
GUANFACINE HYDROCHLORIDE - INTUNIV
N 022037 001 5854290 Sep 21, 2015
6287599 Dec 20, 2020
6811794 Jul 04, 2022
GUANFACINE HYDROCHLORIDE - INTUNIV
U-494
DP
DP U-494
Y I-635 Feb 25, 2014
N 022037 002 5854290 Sep 21, 2015
6287599 Dec 20, 2020
6811794 Jul 04, 2022
GUANFACINE HYDROCHLORIDE - INTUNIV
U-494
DP
DP U-494
Y I-635 Feb 25, 2014
N 022037 003 5854290 Sep 21, 2015
6287599 Dec 20, 2020
6811794 Jul 04, 2022
GUANFACINE HYDROCHLORIDE - INTUNIV
U-494
DP
DP U-494
Y I-635 Feb 25, 2014
N 022037 004 5854290 Sep 21, 2015
6287599 Dec 20, 2020
6811794 Jul 04, 2022
HEXAMINOLEVULINATE HYDROCHLORIDE - CYSVIEW KIT
U-494
DP
DP U-494
Y I-635 Feb 25, 2014
N 022555 001 6034267 Mar 08, 2016
7247655 Mar 08, 2016
7348361 Apr 22, 2019
7530461 Jan 11, 2017
HISTRELIN ACETATE - SUPPRELIN LA
U-1087
DP U-1087
DP U-1087
DP U-1087
N 022058 001 8062652 Jun 16, 2026
HYALURONIDASE RECOMBINANT HUMAN - HYLENEX RECOMBINANT
U-1197 ODE May 03, 2014
N 021859 001 7767429 Sep 23, 2027 DS DP
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE - BIDIL
N 020727 001 6465463 Sep 08, 2020 U-71
6784177 Sep 08, 2020 U-71
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N 020758 001 5994348 Jun 07, 2015
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N 020758 002 5994348 Jun 07, 2015
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N 020758 003 5994348 Jun 07, 2015
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N 020758 004 5994348 Jun 07, 2015 DP
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
N 021532 002 5616599 Apr 25, 2016 DS DP U-500
6878703 Nov 19, 2021 U-3
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
N 021532 003 5616599 Apr 25, 2016 DS DP U-500
6878703 Nov 19, 2021 U-3
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
N 021532 005 5616599 Apr 25, 2016 DS DP U-500
6878703 Nov 19, 2021 U-3
Y
Y
Y
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 93 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT
N 021162 001 5591762 Jan 07, 2014
6358986 Jan 10, 2020
DS DP U-3
HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT
N 021162 002 5591762 Jan 07, 2014
6358986 Jan 10, 2020
DS DP U-3
HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT
N 021162 003 5591762 Jan 07, 2014 DS DP U-3
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N 020818 001 6294197 Jun 18, 2017 U-3
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N 020818 002 6294197 Jun 18, 2017 U-3
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N 020818 003 6294197 Jun 18, 2017 U-3
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N 020818 004 6294197 Jun 18, 2017 U-3
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N 020818 005 6294197 Jun 18, 2017 U-3
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 001 6902742 Nov 01, 2019 DP NP Oct 25, 2016
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 002 6902742 Nov 01, 2019 DP NP Oct 25, 2016
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 003 6902742 Nov 01, 2019 DP NP Oct 25, 2016
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 004 6902742 Nov 01, 2019 DP NP Oct 25, 2016
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 005 6902742 Nov 01, 2019 DP NP Oct 25, 2016
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 006 6902742 Nov 01, 2019 DP NP Oct 25, 2016
HYDROCODONE BITARTRATE; IBUPROFEN - VICOPROFEN
N 020716 001 6348216 Jun 10, 2017
6599531 Jun 10, 2017
HYDROCORTISONE BUTYRATE - LOCOID LIPOCREAM
N 020769 001 5635497 Jun 03, 2014
HYDROCORTISONE BUTYRATE - LOCOID
N 022076 001 7378405 Dec 19, 2026
7981877 Jan 23, 2025
DP
DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP
N 019034 001 6589960 Nov 09, 2020 DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP
N 019034 002 6589960 Nov 09, 2020 DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019034 003 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019034 004 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019034 005 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019891 001 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019892 001 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019892 002 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019892 003 6589960 Nov 09, 2020 DS DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 94 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N 021044 001 5958452
5965161
6335033
6589960
6706281
6743442
Nov 04, 2014
Nov 04, 2014
Nov 04, 2014
Nov 09, 2020
Nov 04, 2014
Nov 04, 2014
DP
DP U-616
DP U-616
DP
DP U-616
DP
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N 021044 002 5958452
5965161
6335033
6589960
6706281
6743442
Nov 04, 2014
Nov 04, 2014
Nov 04, 2014
Nov 09, 2020
Nov 04, 2014
Nov 04, 2014
DP
DP U-616
DP U-616
DP
DP U-616
DP
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N 021044 003 5958452
5965161
6335033
6589960
6706281
6743442
Nov 04, 2014
Nov 04, 2014
Nov 04, 2014
Nov 09, 2020
Nov 04, 2014
Nov 04, 2014
DP
DP U-616
DP U-616
DP
DP U-616
DP
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N 021044 004 5958452
5965161
6335033
6589960
6706281
6743442
Nov 04, 2014
Nov 04, 2014
Nov 04, 2014
Nov 09, 2020
Nov 04, 2014
Nov 04, 2014
DP
DP U-616
DP U-616
DP
DP U-616
DP
HYDROMORPHONE HYDROCHLORIDE - EXALGO
N 021217 001 5702725
5914131
Jul 07, 2014
Jul 07, 2014
DP U-1043
DP U-1043
HYDROMORPHONE HYDROCHLORIDE - EXALGO
N 021217 002 5702725
5914131
Jul 07, 2014
Jul 07, 2014
DP U-1043
DP U-1043
HYDROMORPHONE HYDROCHLORIDE - EXALGO
N 021217 003 5702725
5914131
Jul 07, 2014
Jul 07, 2014
DP U-1043
DP U-1043
HYDROMORPHONE HYDROCHLORIDE - EXALGO
N 021217 004 5702725
5914131
Jul 07, 2014
Jul 07, 2014
DP U-1043
DP U-1043
HYDROXOCOBALAMIN - CYANOKIT
N 022041 001 5834448 Nov 14, 2016 DP ODE Dec 15, 2013
HYDROXOCOBALAMIN - CYANOKIT
N 022041 002 5834448 Nov 14, 2016 DP U-789 ODE Dec 15, 2013
HYDROXYPROGESTERONE CAPROATE - MAKENA
N 021945 001 ODE Feb 03, 2018
IBANDRONATE SODIUM - BONIVA
N 021455 001 6143326
6294196
Apr 21, 2017
Oct 07, 2019
U-642
DP
IBANDRONATE SODIUM - BONIVA
N 021455 002 6294196
7192938
7410957
7718634
IBANDRONATE SODIUM - BONIVA
Oct 07, 2019
May 06, 2023
May 06, 2023
May 06, 2023
DP
U-798
U-887
U-642
N 021858 001 5662918 Sep 02, 2014 DP
IBRUTINIB - IMBRUVICA
N 205552 001 7514444
8008309
8476284
8497277
Dec 28, 2026
Dec 28, 2026
Dec 28, 2026
Dec 28, 2026
DS DP
DS DP
U-1456
U-1456
NCE
ODE
Nov 13, 2018
Nov 13, 2020
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 95 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
IBUPROFEN - MIDOL LIQUID GELS
N 021472 001 6251426 Jun 25, 2018
IBUPROFEN - CALDOLOR
N 022348 001 6727286 Nov 27, 2021 DP U-981
IBUPROFEN - CALDOLOR
N 022348 002 6727286 Nov 27, 2021 DP U-981
IBUPROFEN LYSINE - NEOPROFEN
N 021903 001 6342530
6342530
6344479
8415337
Nov 14, 2020
Nov 14, 2020
Mar 20, 2021
Mar 02, 2032
DP U-794
DP U-1127
DS DP U-794
DS DP
Y
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - CHILDREN'S MOTRIN COLD
N 021128 001 6211246 Jun 10, 2019
ICATIBANT ACETATE - FIRAZYR
N 022150 001 5648333 Jul 15, 2014 DS DP U-1187 NCE
ODE
Aug 25, 2016
Aug 25, 2018
ICODEXTRIN - EXTRANEAL
N 021321 001 6077836
6248726
Jun 20, 2017
Jun 19, 2018
U-495
U-495
ICOSAPENT ETHYL - VASCEPA
N 202057 001 8188146
8293727
8293728
8298554
8314086
8318715
8357677
8367652
8377920
8399446
8415335
8426399
8431560
8440650
8445003
8445013
8501225
8518929
8524698
8546372
8551521
8563608
8617593
8617594
8623406
Jan 27, 2020
Feb 09, 2030
Feb 09, 2030
Apr 29, 2030
Feb 09, 2030
Feb 09, 2030
Feb 09, 2030
Feb 09, 2030
Feb 09, 2030
Feb 09, 2030
Feb 09, 2030
Feb 09, 2030
Feb 09, 2030
Feb 09, 2030
Apr 29, 2030
Apr 29, 2030
Apr 29, 2030
Apr 29, 2030
Apr 29, 2030
Apr 29, 2030
Apr 29, 2030
Apr 29, 2030
Apr 29, 2030
Apr 29, 2030
Apr 29, 2030
DS DP
U-1287
U-1287
DP
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1287
U-1478
U-1287
ILOPERIDONE - FANAPT
N 022192 001 RE39198
ILOPERIDONE - FANAPT
Nov 15, 2016 DS DP U-971 NCE May 06, 2014
N 022192 002 RE39198
ILOPERIDONE - FANAPT
Nov 15, 2016 DS DP U-971 NCE May 06, 2014
N 022192 003 RE39198
ILOPERIDONE - FANAPT
Nov 15, 2016 DS DP U-971 NCE May 06, 2014
N 022192 004 RE39198
ILOPERIDONE - FANAPT
Nov 15, 2016 DS DP U-971 NCE May 06, 2014
N 022192 005 RE39198
ILOPERIDONE - FANAPT
Nov 15, 2016 DS DP U-971 NCE May 06, 2014
N 022192 006 RE39198
ILOPERIDONE - FANAPT
Nov 15, 2016 DS DP U-971 NCE May 06, 2014
N 022192 007 RE39198 Nov 15, 2016 DS DP U-971 NCE May 06, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 96 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
IMATINIB MESYLATE - GLEEVEC
N 021335 001 5521184
6894051
6958335
Jan 04, 2015
May 23, 2019
Dec 19, 2021
DS DP
DS DP U-649
U-791
IMATINIB MESYLATE - GLEEVEC
N 021335 002 5521184
6894051
6958335
Jan 04, 2015
May 23, 2019
Dec 19, 2021
DS DP U-649
DS DP U-649
U-791
IMATINIB MESYLATE - GLEEVEC
N 021588 001 5521184
6894051
6958335
7544799
7544799*PED
RE43932
RE43932*PED
Jan 04, 2015
May 23, 2019
Dec 19, 2021
Jan 16, 2019
Jul 16, 2019
Jan 16, 2019
Jul 16, 2019
DS DP
DS DP U-649
U-791
DS DP
DS DP
Y
I-666
ODE
ODE
ODE
ODE
ODE
ODE
ODE
Jan 25, 2016
Oct 19, 2013
Jan 25, 2020
Oct 19, 2013
Oct 19, 2013
Oct 19, 2013
Oct 19, 2013
Dec 19, 2015
IMATINIB MESYLATE - GLEEVEC
N 021588 002 5521184
6894051
6958335
7544799
7544799*PED
RE43932
RE43932*PED
Jan 04, 2015
May 23, 2019
Dec 19, 2021
Jan 16, 2019
Jul 16, 2019
Jan 16, 2019
Jul 16, 2019
DS DP U-649
U-791
DS DP
DS DP
Y
I-666
ODE
ODE
ODE
ODE
ODE
ODE
ODE
Jan 25, 2016
Dec 19, 2015
Oct 19, 2013
Oct 19, 2013
Oct 19, 2013
Oct 19, 2013
Oct 19, 2013
Jan 25, 2020
IMIGLUCERASE - CEREZYME
N 020367 001 5549892
IMIGLUCERASE - CEREZYME
Aug 27, 2013 U-252
N 020367 002 5549892 Aug 27, 2013 U-252
IMIQUIMOD - ALDARA
N 020723 001 7696159
7696159
Apr 01, 2024
Apr 01, 2024
DS
DS
U-1047
U-1048
IMIQUIMOD - ZYCLARA
N 022483 001 8236816
8299109
8598196
8598196
IMIQUIMOD - ZYCLARA
N 022483 002 8222270
Dec 11, 2029
Dec 11, 2029
Aug 18, 2029
Aug 18, 2029
Dec 11, 2029
U-68
U-68
U-172
U-1455
U-68
I-636
NS
Mar 24, 2014
Jul 15, 2014
INDACATEROL MALEATE - ARCAPTA NEOHALER
N 022383 001 6878721
8067437
8479730
Oct 10, 2020
Jun 02, 2020
Oct 11, 2028
DS DP U-1168
U-1168
DP
NCE Jul 01, 2016
INDINAVIR SULFATE - CRIXIVAN
N 020685 001 6645961
6689761
Mar 04, 2018
Feb 10, 2021
DP
U-554
INDINAVIR SULFATE - CRIXIVAN
N 020685 003 6645961
6689761
Mar 04, 2018
Feb 10, 2021
DP
U-554
INDINAVIR SULFATE - CRIXIVAN
N 020685 005 6645961
6689761
Mar 04, 2018
Feb 10, 2021
DP
U-554
INDINAVIR SULFATE - CRIXIVAN
N 020685 006 6645961
6689761
Mar 04, 2018
Feb 10, 2021
DP
U-554
INDIUM IN-111 PENTETREOTIDE KIT - OCTREOSCAN
N 020314 001 5753627
5776894
6123916
May 19, 2015
Jul 07, 2015
Sep 26, 2017
U-1125
DS DP
U-1125
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 97 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
INGENOL MEBUTATE - PICATO
N 202833 001 6432452 Aug 19, 2018 DS U-68 NCE Jan 23, 2017
6844013 Dec 13, 2018 DS DP U-1221
7410656 Aug 19, 2018 DS U-1222
8278292 Feb 20, 2027 DS DP
8372827 Dec 18, 2026 DS DP
8372828 Dec 18, 2026 DS DP
8377919 Dec 18, 2026 DS DP
8536163 Dec 18, 2026 U-1440
INGENOL MEBUTATE - PICATO
N 202833 002 6432452 Aug 19, 2018 DS U-68 NCE Jan 23, 2017
6844013 Dec 13, 2018 DS DP U-1221
7410656 Aug 19, 2018 DS U-1222
8278292 Feb 20, 2027 DS DP
8372827 Dec 18, 2026 DS DP
8372828 Dec 18, 2026 DS DP
8377919 Dec 18, 2026 DS DP
8536163 Dec 18, 2026 U-1440
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30
N 021172 001 5547930 Sep 28, 2013 DS DP
5618913 Jun 07, 2014 DS DP
5834422 Sep 28, 2013 DP U-471
5840680 Sep 28, 2013 DS DP U-471
5866538 Jun 19, 2017 DP
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 PENFILL
N 021172 002 5547930 Sep 28, 2013 DS DP
5618913 Jun 07, 2014 DS DP
5834422 Sep 28, 2013 DP U-471
5840680 Sep 28, 2013 DS DP U-471
5866538 Jun 19, 2017 DP
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 PENFILL
N 021172 003 5547930 Sep 28, 2013 DS DP
5618913 Jun 07, 2014 DS DP
5834422 Sep 28, 2013 DP U-471
5840680 Sep 28, 2013 DS DP U-471
5866538 Jun 19, 2017 DP
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 FLEXPEN
N 021172 004 5547930 Sep 28, 2013 DS DP
5618913 Jun 07, 2014 DS DP
5834422 Sep 28, 2013 DP U-471
5840680 Sep 28, 2013 DS DP U-471
5866538 Jun 19, 2017 DP
6004297 Jan 28, 2019 DP
RE41956 Jan 21, 2021 DP
RE43834 Jan 28, 2019 DP
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 50/50
N 021810 001 5547930 Sep 28, 2013 DS DP
5618913 Jun 07, 2014 DS DP
5834422 Sep 28, 2013 DP U-471
5840680 Sep 28, 2013 DS DP U-471
5866538 Jun 20, 2017 DP
INSULIN ASPART RECOMBINANT - NOVOLOG
N 020986 001 5618913 Jun 07, 2014 DS DP
5866538 Jun 20, 2017 DP
INSULIN ASPART RECOMBINANT - NOVOLOG PENFILL
N 020986 002 5618913 Jun 07, 2014 DS DP
5626566 May 06, 2014 DP
5693027 Dec 02, 2014 DP
5866538 Jun 20, 2017 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 98 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
NO PATENT NO EXPIRATION
DATE
INSULIN ASPART RECOMBINANT - NOVOLOG FLEXPEN
N 020986 003 5618913 Jun 07, 2014
5866538 Jun 20, 2017
6004297 Jan 28, 2019
RE41956 Jan 21, 2021
RE43834 Jan 28, 2019
INSULIN ASPART RECOMBINANT - NOVOLOG INNOLET
N 020986 004 5618913 Jun 07, 2014
5866538 Jun 20, 2017
RE41956 Jan 21, 2021
INSULIN DETEMIR RECOMBINANT - LEVEMIR
N 021536 001 5750497 Jun 16, 2019
5866538 Jun 20, 2017
6011007 Feb 02, 2014
6869930 Feb 02, 2014
INSULIN DETEMIR RECOMBINANT - LEVEMIR FLEXPEN
N 021536 002 5750497 Jun 16, 2019
5866538 Jun 20, 2017
6004297 Jan 28, 2019
6011007 Feb 02, 2014
6869930 Feb 02, 2014
RE41956 Jan 21, 2021
RE43834 Jan 28, 2019
INSULIN DETEMIR RECOMBINANT - LEVEMIR INNOLET
N 021536 003 5750497 Jun 16, 2019
5866538 Jun 20, 2017
6011007 Feb 02, 2014
6869930 Feb 02, 2014
INSULIN DETEMIR RECOMBINANT - LEVEMIR PENFILL
N 021536 004 5750497 Jun 16, 2019
5866538 Jun 20, 2017
6011007 Feb 02, 2014
6869930 Feb 02, 2014
INSULIN GLARGINE RECOMBINANT - LANTUS
N 021081 001 5656722 Aug 12, 2014
7476652 Jul 23, 2023
7713930 Jun 13, 2023
7918833 Sep 23, 2027
INSULIN GLARGINE RECOMBINANT - LANTUS SOLOSTAR
N 021081 002 8512297 Sep 15, 2024
8556864 Mar 03, 2024
8603044 Mar 02, 2024
INSULIN GLULISINE RECOMBINANT - APIDRA
N 021629 001 6221633 Jun 18, 2018
6960561 Jan 25, 2023
7452860 Mar 22, 2022
7696162 Mar 22, 2022
INSULIN GLULISINE RECOMBINANT - APIDRA
N 021629 002 6221633 Jun 18, 2018
6960561 Jan 25, 2023
7452860 Mar 22, 2022
7696162 Mar 22, 2022
INSULIN GLULISINE RECOMBINANT - APIDRA SOLOSTAR
N 021629 003 6221633 Jun 18, 2018
6960561 Jan 25, 2023
7452860 Mar 22, 2022
7696162 Mar 22, 2022
7918833 Sep 23, 2027
8512297 Sep 15, 2024
8556864 Mar 03, 2024
8603044 Mar 02, 2024
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DS DP
DP
DP
DP
DP
DS DP
DP
DP
DS DP U-668
DS DP
DS DP U-668
DS DP U-668
M-115
M-117
Apr 06, 2015
May 18, 2015
DS DP U-668
DS DP
DP
DS DP U-668
DS DP U-668
DP
DP
DS DP U-668
DS DP
DS DP U-668
DS DP U-668
DS DP U-668
DS DP
DS DP U-668
DS DP U-668
DS DP U-948
DP
DP
DP
DP
DP
DP
DS DP U-471
DP U-471
DP
DP U-471
DS DP U-471
DP U-471
DP
DP U-471
DS DP U-471
DP U-471
DP
DP U-471
DP
DP
DP
DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 99 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 75/25
N 021017 001 5461031 Jun 16, 2014 DP U-948
5474978 Jun 16, 2014 DS DP U-948
5747642 Jun 16, 2014 DP
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 75/25 KWIKPEN
N 021017 002 5461031 Jun 16, 2014 DP U-948
5474978 Jun 16, 2014 DS DP U-948
5747642 Jun 16, 2014 DP
7291132 Aug 09, 2024 DP
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 50/50
N 021018 001 5461031 Jun 16, 2014 DP U-948
5474978 Jun 16, 2014 DS DP U-948
5747642 Jun 16, 2014 DP
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 50/50 KWIKPEN
N 021018 002 5461031 Jun 16, 2014 DP U-948
5474978 Jun 16, 2014 DS DP U-948
5747642 Jun 16, 2014 DP
7291132 Aug 09, 2024 DP
INSULIN LISPRO RECOMBINANT - HUMALOG
N 020563 001 5474978 Jun 16, 2014 DS DP U-534 NR Oct 12, 2015
5474978 Jun 16, 2014 DS DP U-948
INSULIN LISPRO RECOMBINANT - HUMALOG PEN
N 020563 002 5474978 Jun 16, 2014 U-534 NR Oct 12, 2015
INSULIN LISPRO RECOMBINANT - HUMALOG KWIKPEN
N 020563 003 5474978 Jun 16, 2014 DS DP U-948
7291132 Aug 09, 2024 DP
INSULIN RECOMBINANT HUMAN - HUMULIN R
N 018780 001 NR Mar 25, 2014
INSULIN RECOMBINANT HUMAN - HUMULIN R PEN
N 018780 005 NR Mar 25, 2014
INSULIN RECOMBINANT HUMAN - EXUBERA
N 021868 001 5740794 Apr 21, 2015 DP
5997848 Mar 07, 2014 U-704
6051256 Mar 07, 2014 DP
6257233 May 14, 2019 U-704
6423344 Mar 07, 2014 DP
6543448 Sep 21, 2014 DP
6546929 May 14, 2019 U-704
6582728 Jun 24, 2020 DP
6592904 Mar 07, 2014 DP
6685967 Sep 11, 2018 DP
6737045 Mar 07, 2014 U-704
INSULIN RECOMBINANT HUMAN - EXUBERA
N 021868 002 5740794 Apr 21, 2015 DP
5997848 Mar 07, 2014 U-704
6051256 Mar 07, 2014 DP
6257233 May 14, 2019 U-704
6423344 Mar 07, 2014 DP
6543448 Sep 21, 2014 DP
6546929 May 14, 2019 U-704
6582728 Jun 24, 2020 DP
6592904 Mar 07, 2014 DP
6685967 Sep 11, 2018 DP
6737045 Mar 07, 2014 U-704
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN - HUMULIN 70/30
N 019717 001 7291132 Aug 09, 2024 DP
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN - HUMULIN 70/30 PEN
N 019717 002 7291132 Aug 09, 2024 DP
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN - HUMULIN N
N 018781 001 7291132 Aug 09, 2024 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 100 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PATENT
EXPIRATION PATENT
PATENT
DELIST EXCLUSIVITY
EXCLUSIVITY
EXPIRATION
DATE
IOBENGUANE SULFATE I-123 - ADREVIEW
CODES REQUESTED CODE(S) DATE
N 022290 001 I-669
NCE
ODE
Mar 20, 2016
Sep 19, 2013
Sep 19, 2015
IOFLUPANE I-123 - DATSCAN
N 022454 001 NCE Jan 14, 2016
IPRATROPIUM BROMIDE - ATROVENT HFA
N 021527 001 5676930
5683677
6739333
6983743
Oct 14, 2014
Nov 04, 2014
May 26, 2020
May 26, 2020
DP
DP
DP
DP
IRBESARTAN - AVAPRO
N 020757 001 6342247 Jun 07, 2015
IRBESARTAN - AVAPRO
N 020757 002 6342247 Jun 07, 2015
IRBESARTAN - AVAPRO
N 020757 003 6342247 Jun 07, 2015
IRINOTECAN HYDROCHLORIDE - CAMPTOSAR
N 020571 001 6403569
6794370
Apr 28, 2020
May 01, 2020
U-449
U-606
IRINOTECAN HYDROCHLORIDE - CAMPTOSAR
N 020571 002 6403569
6794370
Apr 28, 2020
May 01, 2020
U-449
U-606
IRON DEXTRAN - DEXFERRUM
N 040024 001 5624668 Sep 29, 2015
IRON SUCROSE - VENOFER
N 021135 001 NPP Sep 21, 2015
IRON SUCROSE - VENOFER
N 021135 002 NPP Sep 21, 2015
IRON SUCROSE - VENOFER
N 021135 005 NPP Sep 21, 2015
ISOTRETINOIN - ABSORICA
N 021951 001 7435427
8367102
Sep 21, 2021
Sep 21, 2021
DP
U-1347
NP May 25, 2015
ISOTRETINOIN - ABSORICA
N 021951 002 7435427
8367102
Sep 21, 2021
Sep 21, 2021
DP
U-1347
NP May 25, 2015
ISOTRETINOIN - ABSORICA
N 021951 003 7435427
8367102
Sep 21, 2021
Sep 21, 2021
DP
U-1347
NP May 25, 2015
ISOTRETINOIN - ABSORICA
N 021951 004 7435427
8367102
Sep 21, 2021
Sep 21, 2021
DP
U-1347
NP May 25, 2015
ITRACONAZOLE - SPORANOX
N 020083 001 5633015 May 27, 2014
ITRACONAZOLE - SPORANOX
N 020657 001 5707975
6407079
Jan 13, 2015
Jun 18, 2019
ITRACONAZOLE - SPORANOX
N 020966 001 6407079 Jun 18, 2019
ITRACONAZOLE - ONMEL
N 022484 001 6509038
7081255
8486456
8591948
May 12, 2017
May 12, 2017
Oct 03, 2028
May 12, 2017
DP U-1054
DP U-1054
DP U-1054
DP U-1054
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 101 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
IVACAFTOR - KALYDECO
N 203188 001 7495103
8324242
8410274
May 20, 2027
Apr 18, 2027
Dec 28, 2026
DS DP
U-1311
DP
NCE
ODE
Jan 31, 2017
Jan 31, 2019
IVERMECTIN - SKLICE
N 202736 001 6103248 May 22, 2018 DP NP Feb 07, 2015
IXABEPILONE - IXEMPRA KIT
N 022065 001 6670384
6670384
7022330
7125899
7312237
RE41393
RE41911
Jan 23, 2022
Jan 23, 2022
Jan 23, 2022
May 26, 2018
Aug 21, 2024
Feb 08, 2022
Sep 28, 2020
DP U-959
DP U-960
DP U-958
DS DP U-957
U-965
U-961
DS DP U-961
M-61
PED
Oct 18, 2014
Apr 18, 2015
IXABEPILONE - IXEMPRA KIT
N 022065 002 6670384
6670384
7022330
7125899
7312237
RE41393
RE41911
Jan 23, 2022
Jan 23, 2022
Jan 23, 2022
May 26, 2018
Aug 21, 2024
Feb 08, 2022
Sep 28, 2020
DP U-959
DP U-960
DP U-958
DS DP U-957
U-965
U-961
DS DP U-961
M-61
PED
Oct 18, 2014
Apr 18, 2015
KETOCONAZOLE - NIZORAL A-D
N 020310 001 5456851 Apr 07, 2014
KETOCONAZOLE - EXTINA
N 021738 001 7553835
8026238
Oct 19, 2018
Oct 19, 2018
DP U-245
DP U-1213
KETOCONAZOLE - XOLEGEL
N 021946 001 7179475
8232276
Dec 04, 2018
Nov 24, 2020
DP U-792
DP
KETOROLAC TROMETHAMINE - ACULAR LS
N 021528 001 8008338
8207215
8377982
8377982*PED
8541463
8541463*PED
May 24, 2027
May 28, 2024
May 28, 2024
Nov 28, 2024
May 28, 2024
Nov 28, 2024
DS DP U-1181
U-1251
U-1363
U-1441
KETOROLAC TROMETHAMINE - SPRIX
N 022382 001 6333044 Dec 25, 2018 DP U-1057
KETOROLAC TROMETHAMINE - ACUVAIL
N 022427 001 7842714
8512717
Aug 15, 2029
Mar 07, 2028
DS DP
DP
LACOSAMIDE - VIMPAT
N 022253 001 5654301
RE38551
Aug 05, 2014
Mar 17, 2022
DS DP U-914
DS DP U-914
NCE Oct 28, 2013
LACOSAMIDE - VIMPAT
N 022253 002 5654301
RE38551
Aug 05, 2014
Mar 17, 2022
DS DP U-914
DS DP U-914
NCE Oct 28, 2013
LACOSAMIDE - VIMPAT
N 022253 003 5654301
RE38551
Aug 05, 2014
Mar 17, 2022
DS DP U-914
DS DP U-914
NCE Oct 28, 2013
LACOSAMIDE - VIMPAT
N 022253 004 5654301
RE38551
Aug 05, 2014
Mar 17, 2022
DS DP U-914
DS DP U-914
NCE Oct 28, 2013
LACOSAMIDE - VIMPAT
N 022254 001 5654301
RE38551
Aug 05, 2014
Mar 17, 2022
DS DP U-911
DS DP U-911
NCE Oct 28, 2013
LACOSAMIDE - VIMPAT
N 022255 001 5654301
RE38551
Aug 05, 2014
Mar 17, 2022
DS DP U-914
DS DP U-914
NCE Oct 28, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 102 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LAMIVUDINE - EPIVIR
N 020564 001 5905082 May 18, 2016 DS DP U-248
LAMIVUDINE - EPIVIR
N 020564 003 5905082 May 18, 2016
LAMIVUDINE - EPIVIR
N 020596 001 6004968 Mar 20, 2018
LAMIVUDINE - EPIVIR-HBV
N 021003 001 5905082
RE39155
May 18, 2016
Jul 02, 2013 U-250
LAMIVUDINE - EPIVIR-HBV
N 021004 001 6004968
RE39155
Mar 20, 2018
Jul 02, 2013 U-250
LAMIVUDINE; ZIDOVUDINE - COMBIVIR
N 020857 001 5905082 May 18, 2016 DS DP U-248
LAMOTRIGINE - LAMICTAL XR
N 022115 001 I-644 Apr 25, 2014
LAMOTRIGINE - LAMICTAL XR
N 022115 002 I-644 Apr 25, 2014
LAMOTRIGINE - LAMICTAL XR
N 022115 003 I-644 Apr 25, 2014
LAMOTRIGINE - LAMICTAL XR
N 022115 004 I-644 Apr 25, 2014
LAMOTRIGINE - LAMICTAL XR
N 022115 005 I-644 Apr 25, 2014
LAMOTRIGINE - LAMICTAL XR
N 022115 006 I-644 Apr 25, 2014
LAMOTRIGINE - LAMICTAL ODT
N 022251 001 7919115 Jan 04, 2029 DS DP
LAMOTRIGINE - LAMICTAL ODT
N 022251 002 7919115 Jan 04, 2029 DS DP
LAMOTRIGINE - LAMICTAL ODT
N 022251 003 7919115 Jan 04, 2029 DS DP
LAMOTRIGINE - LAMICTAL ODT
N 022251 004 7919115 Jan 04, 2029 DS DP
LANREOTIDE ACETATE - SOMATULINE DEPOT
N 022074 001 5595760 Mar 08, 2020 DP U-831 D-131
ODE
Mar 04, 2014
Aug 30, 2014
LANREOTIDE ACETATE - SOMATULINE DEPOT
N 022074 002 5595760 Mar 08, 2020 DP U-831 D-131
ODE
Mar 04, 2014
Aug 30, 2014
LANREOTIDE ACETATE - SOMATULINE DEPOT
N 022074 003 5595760 Mar 08, 2020 DP U-831 D-131
ODE
Mar 04, 2014
Aug 30, 2014
LANSOPRAZOLE - PREVACID
N 021428 001 6328994
7399485
7431942
7875292
May 17, 2019
May 26, 2018
May 17, 2019
May 17, 2019
DP
DP
DP
LANSOPRAZOLE - PREVACID
N 021428 002 6328994
7399485
7431942
7875292
May 17, 2019
May 26, 2018
May 17, 2019
May 17, 2019
DP
DP
DP
LANSOPRAZOLE - PREVACID IV
N 021566 001 7396841 Aug 17, 2021 DP U-947
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 103 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
LANTHANUM CARBONATE - FOSRENOL
N 021468 001 5968976
7381428
7465465
LANTHANUM CARBONATE - FOSRENOL
N 021468 002 5968976
7381428
7465465
LANTHANUM CARBONATE - FOSRENOL
N 021468 003 5968976
7381428
7465465
LANTHANUM CARBONATE - FOSRENOL
N 021468 004 5968976
7381428
7465465
LAPATINIB DITOSYLATE - TYKERB
N 022059 001 6391874
6391874
6713485
6713485
6727256
6727256
6828320
6828320
7157466
8513262
PATENT
EXPIRATION
DATE
Oct 26, 2018
Aug 26, 2024
Aug 26, 2024
Oct 26, 2018
Aug 26, 2024
Aug 26, 2024
Oct 26, 2018
Aug 26, 2024
Aug 26, 2024
Oct 26, 2018
Aug 26, 2024
Aug 26, 2024
Jul 11, 2017
Jul 11, 2017
Sep 29, 2020
Sep 29, 2020
Jan 08, 2019
Jan 08, 2019
Jul 11, 2017
Jul 11, 2017
Nov 19, 2021
Jan 08, 2019
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
DP U-613
U-890
DP
DP U-613
U-890
DP
DP U-613
U-890
DP
DP U-613
U-890
DP
DS DP U-800
DS DP U-1429
DS DP U-800
DS DP U-1429
DS DP U-800
DS DP U-1429
U-800
U-1429
DS DP
DS DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 104 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LENALIDOMIDE - REVLIMID
N 021880 001 5635517 Oct 04, 2019 DS U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1212
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
LENALIDOMIDE - REVLIMID
N 021880 002 5635517 Oct 04, 2019 DS U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1212
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 105 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LENALIDOMIDE - REVLIMID
N 021880 003 5635517 Oct 04, 2019 DS U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1212
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
LENALIDOMIDE - REVLIMID
N 021880 004 5635517 Oct 04, 2019 DS U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1212
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 106 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LENALIDOMIDE - REVLIMID
N 021880 005 5635517 Oct 04, 2019 DS U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1212
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
LENALIDOMIDE - REVLIMID
N 021880 006 5635517 Oct 04, 2019 DS DP U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 NS Jun 05, 2016
6281230 Jul 24, 2016 U-1212 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
LEUPROLIDE ACETATE - LUPRON DEPOT
N 019732 001 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT
N 020011 001 5575987 Sep 02, 2013
5631021 May 20, 2014
5716640 Sep 02, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 107 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 002 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
M-107 Oct 08, 2014
N 020263 005 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
M-107 Oct 08, 2014
N 020263 006 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
M-107 Oct 08, 2014
N 020263 007 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
DP
DP
DP
DP
NP Aug 15, 2014
N 020263 008 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT
DP
DP
DP
DP
NP Aug 15, 2014
N 020517 001 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT
N 020517 002 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT
N 020517 003 6036976 Dec 13, 2016
7429559 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT
DP
DP
D-132
NS
Jun 17, 2014
Jun 17, 2014
N 020708 001 5575987
5631020
5716640
6036976
LEUPROLIDE ACETATE - VIADUR
Sep 02, 2013
May 20, 2014
Sep 02, 2013
Dec 13, 2016
N 021088 001 5728396
5932547
5985305
6113938
6124261
6132420
6156331
6235712
6375978
6395292
Jan 30, 2017
Jun 13, 2017
Jan 30, 2017
Jul 24, 2018
Jun 13, 2017
Jan 30, 2017
Jan 30, 2017
Jun 13, 2017
Dec 17, 2018
Jan 30, 2017
U-316
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 108 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LEUPROLIDE ACETATE - ELIGARD
N 021343 001 5599552 Feb 04, 2014
6395293 Sep 28, 2013 DP U-801
6565874 Oct 28, 2018 DP U-801
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 DP U-801
LEUPROLIDE ACETATE - ELIGARD
N 021379 001 5599552 Feb 04, 2014
6395293 Sep 28, 2013 DP
6565874 Oct 28, 2018 DP U-801
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 DP U-801
LEUPROLIDE ACETATE - ELIGARD
N 021488 001 5599552 Feb 04, 2014
6395293 Sep 28, 2013 DP
6565874 Oct 28, 2018 DP U-801
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 DP U-801
LEUPROLIDE ACETATE - ELIGARD
N 021731 001 5599552 Feb 04, 2014 DP U-621
6395293 Sep 28, 2013 DP
6565874 Oct 28, 2018 DP U-621
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 U-621
LEUPROLIDE ACETATE; LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 003 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2013
LEUPROLIDE ACETATE; LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 004 5575987 Sep 02, 2013
5631020 May 20, 2014
5716640 Sep 02, 2013
6036976 Dec 13, 2013
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N 020837 001 5547994 Aug 20, 2013 U-332
6451289 Mar 21, 2021
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N 020837 002 5547994 Aug 20, 2013 U-332
6451289 Mar 21, 2021
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N 020837 003 5547994 Aug 20, 2013 U-332
6451289 Mar 21, 2021
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N 020837 004 5547994 Aug 20, 2013 U-332
6451289 Mar 21, 2021 DP
LEVALBUTEROL TARTRATE - XOPENEX HFA
N 021730 001 5547994 Aug 20, 2013 U-636
5605674 Feb 25, 2014 DP
5836299 Nov 17, 2015 DP
7256310 Oct 08, 2024 DS DP U-636
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 109 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LEVETIRACETAM - KEPPRA
N 021035 001 NPP
PED
Dec 16, 2014
Jun 16, 2015
LEVETIRACETAM - KEPPRA
N 021035 002 NPP
PED
Dec 16, 2014
Jun 16, 2015
LEVETIRACETAM - KEPPRA
N 021035 003 NPP
PED
Dec 16, 2014
Jun 16, 2015
LEVETIRACETAM - KEPPRA
N 021035 004 NPP
PED
Dec 16, 2014
Jun 16, 2015
LEVETIRACETAM - KEPPRA
N 021505 001 NPP
PED
Dec 16, 2014
Jun 16, 2015
LEVETIRACETAM - KEPPRA XR
N 022285 001 7858122 Sep 17, 2028 DP
LEVETIRACETAM - KEPPRA XR
N 022285 002 7858122 Sep 17, 2028 DP
LEVOBETAXOLOL HYDROCHLORIDE - BETAXON
N 021114 001 5540918 Jul 30, 2013 DP
LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE
N 020997 001 5708011 Oct 13, 2014 U-276
LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE
N 020997 002 5708011 Oct 13, 2014 U-276
LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE
N 020997 003 5708011 Oct 13, 2014 U-276
LEVOCARNITINE - CARNITOR
N 020182 001 6335369
6429230
6696493
Jan 18, 2021
Jan 18, 2021
Jan 18, 2021
U-433
U-433
U-433
LEVOCETIRIZINE DIHYDROCHLORIDE - XYZAL
N 022064 001 5698558 Jul 26, 2013 U-812
LEVOCETIRIZINE DIHYDROCHLORIDE - XYZAL
N 022157 001 5698558 Jul 26, 2013 U-852
LEVOFLOXACIN - LEVAQUIN
N 021721 001 6806256 Feb 26, 2022 DP
LEVOLEUCOVORIN CALCIUM - FUSILEV
N 020140 001 6500829 Mar 07, 2022 DS DP I-637
ODE
ODE
Apr 29, 2014
Apr 29, 2018
Mar 07, 2015
LEVOLEUCOVORIN CALCIUM - FUSILEV
N 020140 002 6500829 Mar 07, 2022 DS DP I-637
ODE
ODE
Apr 29, 2014
Apr 29, 2018
Mar 07, 2015
LEVOLEUCOVORIN CALCIUM - FUSILEV
N 020140 003 6500829 Mar 07, 2022 DS DP I-637
ODE
ODE
Apr 29, 2014
Apr 29, 2018
Mar 07, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 110 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA
N 204168 001 8481598 Mar 02, 2031
RE43879 Jun 03, 2023
LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA
U-839
U-839
NCE* Jul 25, 2018
N 204168 002 8481598 Mar 02, 2031
RE43879 Jun 03, 2023
LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA
U-839
U-839
NCE* Jul 25, 2018
N 204168 003 8481598 Mar 02, 2031
RE43879 Jun 03, 2023
LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA
U-839
U-839
NCE* Jul 25, 2018
N 204168 004 8481598
RE43879
LEVONORGESTREL - MIRENA
Mar 02, 2031
Jun 03, 2023
U-839
U-839
NCE* Jul 25, 2018
N 021225 001 5785053 Dec 05, 2015
LEVONORGESTREL - PLAN B ONE-STEP
DP
N 021998 001
LEVONORGESTREL - SKYLA
RTO*
RTO**
Apr 30, 2016
Apr 30, 2016
N 203159 001 5785053
7252839
Dec 05, 2015
Nov 13, 2023
DP
DP
NP Jan 09, 2016
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 111 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
LEVOTHYROXINE SODIUM - LEVOXYL
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021301 001 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 002 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 003 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 004 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 005 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 006 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 007 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 008 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 009 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 010 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 011 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 012 6555581
7067148
7101569
Feb 15, 2022
Feb 15, 2022
Oct 02, 2023
DP
U-759
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 112 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 001 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 002 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 003 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 004 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 005 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 006 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 007 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 008 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 009 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 010 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 011 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 002 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 003 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 004 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 005 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 006 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 007 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 008 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 009 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 010 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 022121 001 7723390 Mar 14, 2024 DP
LIDOCAINE - LIDODERM
N 020612 001 5741510
5827529
Mar 30, 2014
Oct 27, 2015
DP
U-486
LIDOCAINE HYDROCHLORIDE - ZINGO
N 022114 001 5630796
5899880
6004286
6881200
8540665
May 20, 2014
May 04, 2016
Mar 17, 2017
Jun 11, 2016
Oct 22, 2029
DP
DP
DP
U-1438
LIDOCAINE; PRILOCAINE - ORAQIX
N 021451 001 6031007 Apr 01, 2017 DP U-553
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 113 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
APPL/PROD
NO PATENT NO
LIDOCAINE; TETRACAINE - SYNERA
N 021623 001 5658583 Jul 28, 2015
5919479 Jul 28, 2015
6306431 Jul 28, 2015
6465006 Jul 28, 2015
6465709 Jul 07, 2020
6546281 Jul 28, 2015
6780426 Jul 28, 2015
LIDOCAINE; TETRACAINE - PLIAGLIS
N 021717 001 5919479 Jul 28, 2015
6528086 Sep 28, 2019
LINACLOTIDE - LINZESS
PATENT
CODES
DP
DP
DP
DP
DP
DP
DP
DP
DP
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 202811 001 7304036
7371727
7704947
7745409
8080526
8110553
LINACLOTIDE - LINZESS
Jan 28, 2024
Jan 28, 2024
Jan 28, 2024
Jan 28, 2024
Jan 28, 2024
Jan 28, 2024
DS DP U-1278
DS
DS DP
DS DP
DS DP
U-1278
NCE Aug 30, 2017
N 202811 002 7304036
7371727
7704947
7745409
8080526
8110553
LINAGLIPTIN - TRADJENTA
Jan 28, 2024
Jan 28, 2024
Jan 28, 2024
Jan 28, 2024
Jan 28, 2024
Jan 28, 2024
DS DP U-1278
DS
DS DP
DS DP
DS DP
U-1278
NCE Aug 30, 2017
N 201280 001 6303661 Apr 24, 2017 U-774
6303661 Apr 24, 2017 U-1270
6890898 Feb 02, 2019 U-493
6890898 Feb 02, 2019 U-1270
7078381 Feb 02, 2019 U-493
7078381 Feb 02, 2019 U-1270
7407955 Aug 12, 2023 DS DP
7459428 Feb 02, 2019 U-493
7459428 Feb 02, 2019 U-1270
8119648 Aug 12, 2023 U-774
8119648 Aug 12, 2023 U-1270
8178541 Aug 12, 2023 U-775
8178541 Aug 12, 2023 U-1244
8178541 Aug 12, 2023 U-1245
8178541 Aug 12, 2023 U-1270
LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO
N 201281 001 6303661 Apr 24, 2017 U-802
6890898 Feb 02, 2019 U-1039
7078381 Feb 02, 2019 U-1039
7407955 Aug 12, 2023 DS DP
7459428 Feb 02, 2019 U-1039
8119648 Aug 12, 2023 U-802
8178541 Aug 12, 2023 DP U-775
LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO
N 201281 002 6303661 Apr 24, 2017 U-802
6890898 Feb 02, 2019 U-1039
7078381 Feb 02, 2019 U-1039
7407955 Aug 12, 2023 DS DP
7459428 Feb 02, 2019 U-1039
8119648 Aug 12, 2023 U-802
8178541 Aug 12, 2023 DP U-775
LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO
N 201281 003 6303661 Apr 24, 2017 U-802
6890898 Feb 02, 2019 U-1039
7078381 Feb 02, 2019 U-1039
M-118
M-121
NCE
NC
NCE
NC
NCE
NC
NCE
Aug 13, 2015
Aug 13, 2015
May 02, 2016
Jan 30, 2015
May 02, 2016
Jan 30, 2015
May 02, 2016
Jan 30, 2015
May 02, 2016
7407955 Aug 12, 2023 DS DP
7459428 Feb 02, 2019 U-1039
8119648 Aug 12, 2023 U-802
8178541 Aug 12, 2023 DP U-775
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 114 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LINEZOLID - ZYVOX
N 021130 001 5688792
6514529
6559305
Nov 18, 2014
Mar 15, 2021
Jan 29, 2021
DS U-319
DP
DS
LINEZOLID - ZYVOX
N 021130 002 5688792
6514529
6559305
Nov 18, 2014
Mar 15, 2021
Jan 29, 2021
DS U-319
DP
DS
LINEZOLID - ZYVOX
N 021131 001 5688792
6559305
Nov 18, 2014
Jan 29, 2021 DS
U-319
LINEZOLID - ZYVOX
N 021132 001 5688792
6559305
Nov 18, 2014
Jan 29, 2021
DS
DS
U-319
LIRAGLUTIDE RECOMBINANT - VICTOZA
N 022341 001 6004297
6268343
6458924
7235627
8114833
RE41956
RE43834
Jan 28, 2019
Aug 22, 2022
Aug 22, 2017
Aug 22, 2017
Aug 13, 2025
Jan 21, 2021
Jan 28, 2019
DP
DS DP U-968
DS DP U-968
DS DP
DP
DP
DP
M-115
NCE
Apr 06, 2015
Jan 25, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 115 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 001 7105486 Jun 29, 2023 U-727 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP NPP Nov 10, 2013
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 002 7105486 Jun 29, 2023 U-727 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP NPP Nov 10, 2013
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 003 7105486 Jun 29, 2023 U-727 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP NPP Nov 10, 2013
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 116 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 004 7105486 Jun 29, 2023 U-842 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP NPP Nov 10, 2013
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 005 7105486 Jun 29, 2023 U-842 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP NPP Nov 10, 2013
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 006 7105486 Jun 29, 2023 U-842 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP NPP Nov 10, 2013
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 117 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LOMITAPIDE MESYLATE - JUXTAPID
N 203858 001 5712279
5739135
6492365
7932268
LOMITAPIDE MESYLATE - JUXTAPID
Feb 21, 2015
Apr 14, 2015
Dec 10, 2019
Aug 19, 2027
DS
DS
U-1317
U-1317
U-1318
U-1316
NCE
ODE
Dec 21, 2017
Dec 21, 2019
N 203858 002 5712279
5739135
6492365
7932268
LOMITAPIDE MESYLATE - JUXTAPID
Feb 21, 2015
Apr 14, 2015
Dec 10, 2019
Aug 19, 2027
DS
DS
U-1317
U-1317
U-1318
U-1316
NCE
ODE
Dec 21, 2017
Dec 21, 2019
N 203858 003 5712279
5739135
6492365
7932268
Feb 21, 2015
Apr 14, 2015
Dec 10, 2019
Aug 19, 2027
DS
DS
U-1317
U-1317
U-1318
U-1316
NCE
ODE
Dec 21, 2017
Dec 21, 2019
LOPERAMIDE HYDROCHLORIDE - IMODIUM A-D EZ CHEWS
N 020448 001 6814978 Aug 26, 2021 DP
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE - IMODIUM MULTI-SYMPTOM RELIEF
N 020606 001 5679376 Oct 21, 2014 Y
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE - IMODIUM MULTI-SYMPTOM RELIEF
N 021140 001 6103260 Jul 17, 2017 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 118 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LOPINAVIR; RITONAVIR - KALETRA
N 021226 001 5541206 Jul 30, 2013 DS U-348
5648497 Jul 15, 2014
5886036 Nov 19, 2013 DS DP
5914332 Dec 13, 2015 U-351
5948436 Sep 13, 2013 DP
6037157 Jun 26, 2016 U-346
6232333 Nov 07, 2017
6284767 Feb 15, 2016 DP U-401
6284767 Feb 15, 2016 DP U-688
6458818 Nov 07, 2017
6521651 Nov 07, 2017 DP
6703403 Jun 26, 2016 U-257
7141593 May 22, 2020 DP
7432294 May 22, 2020 DP
LOPINAVIR; RITONAVIR - KALETRA
N 021251 001 5484801 Jan 28, 2014 DP
5541206 Jul 30, 2013 DS DP U-348
5541206 Jul 30, 2013 DS DP U-895
5648497 Jul 15, 2014 DS
5886036 Nov 19, 2013 DS DP U-895
5914332 Dec 13, 2015 DS DP U-351
5914332 Dec 13, 2015 DS DP U-895
5948436 Sep 13, 2013 DP
6037157 Jun 26, 2016 U-346
6037157 Jun 26, 2016 U-895
6284767 Feb 15, 2016 DP U-401
6284767 Feb 15, 2016 DP U-895
6703403 Jun 26, 2016 U-257
6703403 Jun 26, 2016 U-895
6911214 Nov 28, 2021 DP U-895
8501219 Nov 28, 2021 DP
LOPINAVIR; RITONAVIR - KALETRA
N 021906 001 5541206 Jul 30, 2013 DS DP U-688
5648497 Jul 15, 2014 DS DP
5886036 Nov 19, 2013 DS DP U-895
5914332 Dec 13, 2015 DS DP U-688
6037157 Jun 26, 2016 U-688
6284767 Feb 15, 2016 DP U-688
6703403 Jun 26, 2016 U-688
7148359 Jul 19, 2019 DP
7364752 Nov 10, 2020 DP U-688
8025899 Dec 14, 2027 DP
8025899*PED Jun 14, 2028
8268349 Aug 25, 2024 DP
8309613 Dec 24, 2024 U-688
8377952 Oct 22, 2027 U-1372
8377952*PED Apr 22, 2028
8399015 Aug 25, 2024 DP
8399015*PED Feb 25, 2025
8470347 Sep 17, 2026 DP
8470347*PED Mar 17, 2027
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 119 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
LOPINAVIR; RITONAVIR - KALETRA
N 021906 002 5541206
5648497
5886036
5914332
6037157
6284767
6703403
7148359
7364752
8025899
8025899*PED
8268349
8309613
8377952
8377952*PED
8399015
8399015*PED
8470347
8470347*PED
LORATADINE - CLARITIN
PATENT
EXPIRATION
DATE
Jul 30, 2013
Jul 15, 2014
Nov 19, 2013
Dec 13, 2015
Jun 26, 2016
Feb 15, 2016
Jun 26, 2016
Jul 19, 2019
Nov 10, 2020
Dec 14, 2027
Jun 14, 2028
Aug 25, 2024
Dec 24, 2024
Oct 22, 2027
Apr 22, 2028
Aug 25, 2024
Feb 25, 2025
Sep 17, 2026
Mar 17, 2027
PATENT
CODES
DS DP U-688
DS DP
DS DP U-895
DS DP U-688
U-688
DP U-688
U-688
DP
DP U-688
DP
DP
U-688
U-1372
DP
DP
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 020641 002 6132758 Jun 01, 2018
LORCASERIN HYDROCHLORIDE - BELVIQ
N 022529 001 6953787 Apr 10, 2023
6953787 Apr 10, 2023
6953787 Apr 10, 2023
6953787 Apr 10, 2023
7514422 Apr 10, 2023
7514422 Apr 10, 2023
7514422 Apr 10, 2023
7514422 Apr 10, 2023
7977329 Apr 10, 2023
7977329 Apr 10, 2023
7977329 Apr 10, 2023
7977329 Apr 10, 2023
8168624 Apr 18, 2029
8207158 Apr 10, 2023
8207158 Apr 10, 2023
8207158 Apr 10, 2023
8207158 Apr 10, 2023
8273734 Apr 10, 2023
8273734 Apr 10, 2023
8367657 Apr 10, 2023
8367657 Apr 10, 2023
8367657 Apr 10, 2023
8367657 Apr 10, 2023
8546379 Apr 10, 2023
8546379 Apr 10, 2023
8546379 Apr 10, 2023
8546379 Apr 10, 2023
8575149 Apr 10, 2023
LOTEPREDNOL ETABONATE - LOTEMAX
DS DP U-1252
DS DP U-1253
DS DP U-1254
DS DP U-1255
U-1252
U-1253
U-1254
U-1255
DS DP U-1252
DS DP U-1253
DS DP U-1254
DS DP U-1255
DS DP
U-1252
U-1253
U-1254
U-1255
U-1254
U-1255
DS DP U-1252
DS DP U-1253
DS DP U-1254
DS DP U-1255
DS DP U-1252
DS DP U-1253
DS DP U-1254
DS DP U-1255
U-1452
NCE Jun 27, 2017
N 020583 001 5540930
5747061
LOTEPREDNOL ETABONATE - ALREX
Oct 25, 2013
Oct 25, 2013 DP U-575
N 020803 001 5540930
5747061
LOTEPREDNOL ETABONATE - LOTEMAX
Oct 25, 2013
Oct 25, 2013 DP U-576
N 020841 001 5540930
LOTEPREDNOL ETABONATE - LOTEMAX
Oct 25, 2013
N 200738 001
LOTEPREDNOL ETABONATE - LOTEMAX
NDF
PED
Apr 15, 2014
Oct 15, 2014
N 202872 001 5800807 Jan 29, 2017 DP NDF Sep 28, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 120 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LOTEPREDNOL ETABONATE; TOBRAMYCIN - ZYLET
N 050804 001 5540930 Oct 25, 2013 DP
5747061 Oct 25, 2013 DP U-920
LOVASTATIN - ALTOPREV
N 021316 001 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
LOVASTATIN - ALTOPREV
N 021316 002 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
LOVASTATIN - ALTOPREV
N 021316 003 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
LOVASTATIN - ALTOPREV
N 021316 004 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 121 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LOVASTATIN; NIACIN - ADVICOR
N 021249 001 6080428 May 27, 2017 U-447
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1133
6080428 May 27, 2017 U-1134
6129930 Sep 20, 2013 DP U-448
6129930 Sep 20, 2013 DP U-1132
6129930 Sep 20, 2013 DP U-1133
6129930 Sep 20, 2013 DP U-1134
6406715 Sep 20, 2013 DP U-450
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1130
6469035 Mar 15, 2018 U-1131
6676967 Sep 20, 2013 U-548
6676967 Sep 20, 2013 U-1132
6676967 Sep 20, 2013 U-1133
6676967 Sep 20, 2013 U-1134
6746691 Sep 20, 2013 DP U-586
6818229 Sep 20, 2013 DP
7011848 Sep 20, 2013 U-712
7011848 Sep 20, 2013 U-1135
7011848 Sep 20, 2013 U-1136
7011848 Sep 20, 2013 U-1137
7998506 Sep 20, 2013 U-1135
7998506 Sep 20, 2013 U-1136
7998506 Sep 20, 2013 U-1137
LOVASTATIN; NIACIN - ADVICOR
N 021249 002 6080428 May 27, 2017 U-447
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1133
6080428 May 27, 2017 U-1134
6129930 Sep 20, 2013 DP U-448
6129930 Sep 20, 2013 DP U-1132
6129930 Sep 20, 2013 DP U-1133
6129930 Sep 20, 2013 DP U-1134
6406715 Sep 20, 2013 DP U-450
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1130
6469035 Mar 15, 2018 U-1131
6676967 Sep 20, 2013 U-548
6676967 Sep 20, 2013 U-1132
6676967 Sep 20, 2013 U-1133
6676967 Sep 20, 2013 U-1134
6746691 Sep 20, 2013 DP U-586
6818229 Sep 20, 2013 DP
7011848 Sep 20, 2013 U-712
7011848 Sep 20, 2013 U-1135
7011848 Sep 20, 2013 U-1136
7011848 Sep 20, 2013 U-1137
7998506 Sep 20, 2013 U-1135
7998506 Sep 20, 2013 U-1136
7998506 Sep 20, 2013 U-1137
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 122 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LOVASTATIN; NIACIN - ADVICOR
N 021249 003 6080428 May 27, 2017 U-447
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1133
6080428 May 27, 2017 U-1134
6129930 Sep 20, 2013 DP U-448
6129930 Sep 20, 2013 DP U-1132
6129930 Sep 20, 2013 DP U-1133
6129930 Sep 20, 2013 DP U-1134
6406715 Sep 20, 2013 DP U-450
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1130
6469035 Mar 15, 2018 U-1131
6676967 Sep 20, 2013 U-548
6676967 Sep 20, 2013 U-1132
6676967 Sep 20, 2013 U-1133
6676967 Sep 20, 2013 U-1134
6746691 Sep 20, 2013 DP U-586
6818229 Sep 20, 2013 DP
7011848 Sep 20, 2013 U-712
7011848 Sep 20, 2013 U-1135
7011848 Sep 20, 2013 U-1136
7011848 Sep 20, 2013 U-1137
7998506 Sep 20, 2013 U-1135
7998506 Sep 20, 2013 U-1136
7998506 Sep 20, 2013 U-1137
LOVASTATIN; NIACIN - ADVICOR
N 021249 004 6080428 May 27, 2017 U-447
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1133
6080428 May 27, 2017 U-1134
6129930 Sep 20, 2013 DP U-448
6129930 Sep 20, 2013 DP U-1132
6129930 Sep 20, 2013 DP U-1133
6129930 Sep 20, 2013 DP U-1134
6406715 Sep 20, 2013 DP
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1130
6469035 Mar 15, 2018 U-1131
6676967 Sep 20, 2013 U-548
6676967 Sep 20, 2013 U-1132
6676967 Sep 20, 2013 U-1133
6676967 Sep 20, 2013 U-1134
6746691 Sep 20, 2013 DP U-586
6818229 Sep 20, 2013 DP
7011848 Sep 20, 2013 U-712
7011848 Sep 20, 2013 U-1135
7011848 Sep 20, 2013 U-1136
7011848 Sep 20, 2013 U-1137
7998506 Sep 20, 2013 U-1135
7998506 Sep 20, 2013 U-1136
7998506 Sep 20, 2013 U-1137
LOXAPINE - ADASUVE
N 022549 001 6716416 May 20, 2022 DP NDF Dec 21, 2015
7052679 Mar 20, 2022 DP
7078020 Oct 26, 2021 DP U-1375
7090830 Oct 26, 2021 DP
7458374 Aug 18, 2024 DP
7537009 Oct 26, 2021 DP
7585493 Oct 26, 2021 DP
7601337 Oct 26, 2021 DP
8074644 Oct 26, 2021 DP
8173107 Oct 26, 2021 DP
8235037 Oct 26, 2021 DP
8387612 Oct 23, 2026 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 123 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LUBIPROSTONE - AMITIZA
N 021908 001 5284858
6414016
6414016
6583174
6982283
7064148
7064148
7417067
8026393
8071613
8071613
8088934
8097649
8097653
8097653
8114890
8338639
8389542
8389542
Jul 14, 2014
Sep 05, 2020
Sep 05, 2020
Oct 16, 2020
Dec 04, 2022
Aug 30, 2022
Aug 30, 2022
Oct 16, 2020
Oct 25, 2027
Sep 05, 2020
Sep 05, 2020
May 18, 2021
Oct 16, 2020
Nov 14, 2022
Nov 14, 2022
Sep 05, 2020
Jan 23, 2027
Nov 14, 2022
Nov 14, 2022
DS
U-717
U-1392
DP
U-1391
U-739
U-1404
DP
DP
U-1203
U-1393
DS
DP
U-1214
U-1394
DP
DP
DP U-1345
DP U-1395
I-670 Apr 19, 2016
LUBIPROSTONE - AMITIZA
N 021908 002 5284858
6414016
6583174
7064148
7064148
7417067
7795312
8026393
8071613
8088934
8097649
8114890
8338639
Jul 14, 2014
Sep 05, 2020
Oct 16, 2020
Aug 30, 2022
Aug 30, 2022
Oct 16, 2020
Sep 17, 2024
Oct 25, 2027
Sep 05, 2020
May 18, 2021
Oct 16, 2020
Sep 05, 2020
Jan 23, 2027
DS
U-874
DP
U-739
U-873
DP
U-1085
DP
U-1202
DS
DP
DP
DP
LUCINACTANT - SURFAXIN
N 021746 001 5407914 Nov 17, 2014 DS DP U-1242
LULICONAZOLE - LUZU
N 204153 001 5900488 Jul 05, 2016 DS DP U-540 NCE Nov 14, 2018
LURASIDONE HYDROCHLORIDE - LATUDA
N 200603 001 5532372 Jul 02, 2018 DS D-134
I-674
NCE
Apr 26, 2015
Jun 28, 2016
Oct 28, 2015
LURASIDONE HYDROCHLORIDE - LATUDA
N 200603 002 5532372 Jul 02, 2018 DS D-134
I-674
NCE
Apr 26, 2015
Jun 28, 2016
Oct 28, 2015
LURASIDONE HYDROCHLORIDE - LATUDA
N 200603 003 5532372 Jul 02, 2018 DS D-134
I-674
NCE
Apr 26, 2015
Jun 28, 2016
Oct 28, 2015
LURASIDONE HYDROCHLORIDE - LATUDA
N 200603 004 5532372 Jul 02, 2018 DS D-134
I-674
NCE
Apr 26, 2015
Jun 28, 2016
Oct 28, 2015
LURASIDONE HYDROCHLORIDE - LATUDA
N 200603 005 D-134
I-674
NCE
Apr 26, 2015
Jun 28, 2016
Oct 28, 2015
LUTROPIN ALFA - LUVERIS
N 021322 001 5767251 Jun 16, 2015 DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 124 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MACITENTAN - OPSUMIT
N 204410 001 7094781 Oct 12, 2022 DS DP NCE Oct 18, 2018
8268847 Apr 18, 2029 U-1446 ODE Oct 18, 2020
8367685 Oct 04, 2028 DP U-1445
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 25
N 021910 001 5945449 Oct 31, 2017 DP U-785 ODE Jul 26, 2013
7300674 Mar 04, 2023 DP U-785
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 35
N 021910 002 5945449 Oct 31, 2017 DP U-785 ODE Jul 26, 2013
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021850 001 6489346 Jul 16, 2016 DS DP U-588
6645988 Jul 16, 2016 DS DP U-588
6699885 Jul 16, 2016 U-588
7399772 Jul 16, 2016 U-588
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021850 002 6489346 Jul 16, 2016 DS DP U-623
6645988 Jul 16, 2016 DS DP U-623
6699885 Jul 16, 2016 U-623
7399772 Jul 16, 2016 U-623
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM
BICARBONATE
N 022456 001 6489346 Jul 16, 2016 DP U-588
6489346 Jul 16, 2016 DP U-1021
6645988 Jul 16, 2016 DP
6699885 Jul 16, 2016 DP U-588
6699885 Jul 16, 2016 DP U-1021
7399772 Jul 16, 2016 DP U-588
7399772 Jul 16, 2016 DP U-1021
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM
BICARBONATE
N 022456 002 6489346 Jul 16, 2016 DP U-588
6489346 Jul 16, 2016 DP U-1021
6645988 Jul 16, 2016 DP
6699885 Jul 16, 2016 DP U-588
6699885 Jul 16, 2016 DP U-1021
7399772 Jul 16, 2016 DP U-588
7399772 Jul 16, 2016 DP U-1021
MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE - SUPREP BOWEL PREP KIT
N 022372 001 6946149 Mar 07, 2023 DP U-837 NC Aug 05, 2013
MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE;
SODIUM CHLORIDE; SODIUM SULFATE - SUCLEAR
N 203595 001 NC Jan 18, 2016
MALATHION - OVIDE
N 018613 001 7560445 Feb 01, 2027 DS DP U-986
7977324 Aug 14, 2026 DP
MANNITOL - ARIDOL KIT
N 022368 001 5817028 Feb 23, 2015 U-1091 NP Oct 05, 2013
MARAVIROC - SELZENTRY
N 022128 001 6586430 Dec 01, 2019 DS DP U-824
6667314 Aug 06, 2021 DS DP U-824
7368460 Nov 25, 2022 U-824
7576097 May 25, 2021 DS
MARAVIROC - SELZENTRY
N 022128 002 6586430 Dec 01, 2019 DS DP U-824
6667314 Aug 06, 2021 DS DP U-824
7368460 Nov 25, 2022 U-824
7576097 May 25, 2021 DS
MECASERMIN RECOMBINANT - INCRELEX
N 021839 001 5681814 Sep 18, 2017 DP
5824642 Jul 08, 2014 U-681
6207640 Apr 07, 2014 U-681
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 125 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
APPL/PROD
NO PATENT NO
MECASERMIN RINFABATE RECOMBINANT - IPLEX
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021884 001 5681818 Oct 28, 2014 U-697
MECHLORETHAMINE HYDROCHLORIDE - VALCHLOR
N 202317 001 7838564
7872050
8450375
8501818
8501819
Mar 07, 2026
Jul 08, 2029
Mar 07, 2026
Mar 07, 2026
Mar 07, 2026
DP
U-1427
DP
DP
U-1427
NDF
ODE
Aug 23, 2016
Aug 23, 2020
MEDROXYPROGESTERONE ACETATE - DEPO-SUBQ PROVERA 104
N 021583 001 6495534 May 15, 2020 DP
MEGESTROL ACETATE - MEGACE ES
N 021778 001 6592903
7101576
Sep 21, 2020
Apr 22, 2024
DP
U-755
MELOXICAM - MOBIC
N 021530 001 6184220 Mar 25, 2019 DP
MEMANTINE HYDROCHLORIDE - NAMENDA
N 021487 001 5061703 Apr 11, 2015
MEMANTINE HYDROCHLORIDE - NAMENDA
U-539
N 021487 002 5061703 Apr 11, 2015
MEMANTINE HYDROCHLORIDE - NAMENDA
U-539
N 021627 001 5061703 Apr 11, 2015 U-539
MEMANTINE HYDROCHLORIDE - NAMENDA XR
N 022525 001 5061703
8039009
8168209
8173708
8283379
8329752
8362085
Apr 11, 2015
Mar 24, 2029
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
U-539
U-539
DP
U-539
U-539
DP
U-539
MEMANTINE HYDROCHLORIDE - NAMENDA XR
N 022525 002 5061703
8039009
8168209
8173708
8283379
8329752
8362085
Apr 11, 2015
Mar 24, 2029
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
U-539
U-539
DP
U-539
U-539
DP
U-539
MEMANTINE HYDROCHLORIDE - NAMENDA XR
N 022525 003 5061703
8039009
8168209
8173708
8283379
8329752
8362085
Apr 11, 2015
Mar 24, 2029
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
U-539
U-539
DP
U-539
U-539
DP
U-539
MEMANTINE HYDROCHLORIDE - NAMENDA XR
N 022525 004 5061703
8039009
8168209
8173708
8283379
8329752
8362085
8598233
Apr 11, 2015
Mar 24, 2029
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
Nov 22, 2025
U-539
U-539
DP
U-539
U-539
DP
U-539
DP
MEQUINOL; TRETINOIN - SOLAGE
N 020922 001 5194247
6353029
Dec 10, 2013
Aug 24, 2020
DP U-294
MESALAMINE - SFROWASA
N 019618 002 7645801 Jul 24, 2027 DS DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 126 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MESALAMINE - ASACOL
N 019651 001 5541170
5541171
Jul 30, 2013
Jul 30, 2013
U-141
U-141
MESALAMINE - CANASA
N 021252 002 8217083
8436051
Jun 06, 2028
Jun 06, 2028
DP
DP
MESALAMINE - ASACOL HD
N 021830 001 5541170
5541171
6893662
8580302
Jul 30, 2013
Jul 30, 2013
Nov 15, 2021
Nov 15, 2021
DP U-141
DP U-141
DP U-141
DP
MESALAMINE - LIALDA
N 022000 001 6773720 Jun 08, 2020 DP I-640 Jul 14, 2014
MESALAMINE - APRISO
N 022301 001 6551620
8337886
8496965
Apr 20, 2018
Apr 20, 2018
Apr 20, 2018
DS DP U-907
DP U-1310
DP
MESALAMINE - DELZICOL
N 204412 001 5541170
5541171
6649180
Jul 30, 2013
Jul 30, 2013
Apr 13, 2020
DP U-141
DP U-141
DP
METAXALONE - SKELAXIN
N 013217 003 7122566
7714006
Feb 06, 2026
Dec 03, 2021
U-915
U-1050
METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR
N 021202 001 6475521
6660300
Mar 19, 2018
Mar 19, 2018 U-542
METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR
N 021202 004 6475521
6660300
Mar 19, 2018
Mar 19, 2018 U-542
METFORMIN HYDROCHLORIDE - FORTAMET
N 021574 001 6099859
6495162
6790459
6866866
7919116
8475841
Mar 20, 2018
Mar 20, 2018
Mar 17, 2021
Mar 17, 2021
Mar 20, 2018
Mar 20, 2018
DP
DP
U-604
DP
DP
U-604
METFORMIN HYDROCHLORIDE - FORTAMET
N 021574 002 6099859
6495162
6790459
6866866
7919116
8475841
Mar 20, 2018
Mar 20, 2018
Mar 17, 2021
Mar 17, 2021
Mar 20, 2018
Mar 20, 2018
DP
DP
U-604
DP
DP
U-604
METFORMIN HYDROCHLORIDE - RIOMET
N 021591 001 6890957 Sep 14, 2023 DP
METFORMIN HYDROCHLORIDE - GLUMETZA
N 021748 001 6340475
6488962
6635280
6723340
Sep 19, 2016
Jun 20, 2020
Sep 19, 2016
Oct 25, 2021
DS DP U-669
DS DP
DS DP
DS DP
METFORMIN HYDROCHLORIDE - GLUMETZA
N 021748 002 6488962
7780987
8323692
Jun 20, 2020
Mar 23, 2025
Mar 23, 2025
DS DP
DS DP
DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 127 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET
N 021842 001 5965584 Jun 19, 2016 DP U-1055 M-116 May 17, 2015
6166042 Jun 19, 2016 U-679
6166043 Jun 19, 2016 U-679
6172090 Jun 19, 2016 U-679
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET
N 021842 002 5965584 Jun 19, 2016 DP U-1055 M-116 May 17, 2015
6166042 Jun 19, 2016 U-679
6166043 Jun 19, 2016 U-679
6172090 Jun 19, 2016 U-679
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET XR
N 022024 001 5965584 Jun 19, 2016 DP U-973
6099859 Mar 20, 2018 DP
6166042 Jun 19, 2016 U-973
6166043 Jun 19, 2016 U-973
6172090 Jun 19, 2016 U-973
6495162 Mar 20, 2018 DP
6790459 Mar 17, 2021 U-974
6866866 Mar 17, 2021 DP
7785627 Jul 31, 2026 DP
7919116 Mar 20, 2018 U-973
7919116 Mar 20, 2018 U-1120
7959946 Jul 31, 2026 DP
8470368 Sep 19, 2023 DP
8475841 Mar 20, 2018 U-973
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET XR
N 022024 002 5965584 Jun 19, 2016 DP U-973
6099859 Mar 20, 2018 DP
6166042 Jun 19, 2016 U-973
6166043 Jun 19, 2016 U-973
6172090 Jun 19, 2016 U-973
6495162 Mar 20, 2018 DP
6790459 Mar 17, 2021 U-974
6866866 Mar 17, 2021 DP
7785627 Jul 31, 2026 DP
7919116 Mar 20, 2018 U-973
7919116 Mar 20, 2018 U-1120
7959946 Jul 31, 2026 DP
8470368 Sep 19, 2023 DP
8475841 Mar 20, 2018 U-973
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 128 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 001 5741803
5741803
5965584
6166042
6288095
7358366
8236345
Apr 21, 2015
Apr 21, 2015
Jun 19, 2016
Jun 19, 2016
Feb 11, 2017
Apr 19, 2020
Oct 07, 2022
DS DP U-493
DS DP U-734
U-493
U-493
U-493
DS
DP
Y
Y
Y
Y
Y
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 002 5741803
5741803
5965584
6166042
6288095
7358366
8236345
Apr 21, 2015
Apr 21, 2015
Jun 19, 2016
Jun 19, 2016
Feb 11, 2017
Apr 19, 2020
Oct 07, 2022
DS DP U-493
DS DP U-734
U-493
U-493
U-493
DS
DP
Y
Y
Y
Y
Y
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 003 5741803
5741803
5965584
6166042
6288095
7358366
8236345
Apr 21, 2015
Apr 21, 2015
Jun 19, 2016
Jun 19, 2016
Feb 11, 2017
Apr 19, 2020
Oct 07, 2022
DS DP U-493
DS DP U-734
U-493
U-493
U-493
DS
DP
Y
Y
Y
Y
Y
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 004 5741803
5741803
7358366
8236345
Apr 21, 2015
Apr 21, 2015
Apr 19, 2020
Oct 07, 2022
DS DP U-493
DS DP U-734
DS
DP
Y
Y
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 005 5741803
5741803
7358366
8236345
Apr 21, 2015
Apr 21, 2015
Apr 19, 2020
Oct 07, 2022
DS DP U-493
DS DP U-734
DS
DP
Y
Y
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR
N 200678 001 RE44186 Jul 31, 2023 DS DP U-1097 NCE Jul 31, 2014
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR
N 200678 002 RE44186 Jul 31, 2023 DS DP U-1097 NCE Jul 31, 2014
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR
N 200678 003 RE44186 Jul 31, 2023 DS DP U-1097 NCE Jul 31, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 129 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET
N 022044 001 6303661 Apr 24, 2017 U-802
6699871 Jul 26, 2022 DS DP U-802
6890898 Feb 02, 2019 U-803
6890898 Feb 02, 2019 U-1036
6890898 Feb 02, 2019 U-1038
7078381 Feb 02, 2019 U-803
7078381 Feb 02, 2019 U-1036
7078381 Feb 02, 2019 U-1038
7125873 Jul 26, 2022 DP U-803
7125873 Jul 26, 2022 DP U-1036
7125873 Jul 26, 2022 DP U-1038
7326708 Apr 11, 2026 DS DP U-802
7459428 Feb 02, 2019 U-1036
8414921 Jul 21, 2028 DP U-1036
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET
N 022044 002 6303661 Apr 24, 2017 U-802
6699871 Jul 26, 2022 DS DP U-802
6890898 Feb 02, 2019 U-803
6890898 Feb 02, 2019 U-1036
6890898 Feb 02, 2019 U-1038
7078381 Feb 02, 2019 U-803
7078381 Feb 02, 2019 U-1036
7078381 Feb 02, 2019 U-1038
7125873 Jul 26, 2022 DP U-803
7125873 Jul 26, 2022 DP U-1036
7125873 Jul 26, 2022 DP U-1038
7326708 Apr 11, 2026 DS DP U-802
7459428 Feb 02, 2019 U-1036
8414921 Jul 21, 2028 DP U-1036
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR
N 202270 001 6303661 Apr 24, 2017 U-1227
6340475 Sep 19, 2016 DP
6635280 Sep 19, 2016 DP
6699871 Jul 26, 2022 DS DP U-1227
6890898 Feb 02, 2019 U-1228
7078381 Feb 02, 2019 U-1227
7125873 Jul 26, 2022 DP U-1227
7326708 Apr 11, 2026 DS DP U-1227
7459428 Feb 02, 2019 U-1227
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR
N 202270 002 6303661 Apr 24, 2017 U-1227
6340475 Sep 19, 2016 DP
6635280 Sep 19, 2016 DP
6699871 Jul 26, 2022 DS DP U-1227
6890898 Feb 02, 2019 U-1228
7078381 Feb 02, 2019 U-1227
7125873 Jul 26, 2022 DP U-1227
7326708 Apr 11, 2026 DS DP U-1227
7459428 Feb 02, 2019 U-1227
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR
N 202270 003 6303661 Apr 24, 2017 U-1227
6340475 Sep 19, 2016 DP
6635280 Sep 19, 2016 DP
6699871 Jul 26, 2022 DS DP U-1227
6890898 Feb 02, 2019 U-1228
7078381 Feb 02, 2019 U-1227
7125873 Jul 26, 2022 DP U-1227
7326708 Apr 11, 2026 DS DP U-1227
7459428 Feb 02, 2019 U-1227
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 130 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METHOTREXATE - OTREXUP
N 204824 001 6746429 Apr 12, 2020 DP
7744582 Aug 10, 2019 DP U-1442
7776015 Aug 10, 2019 DP
8021335 Oct 04, 2026 DP
8480631 Mar 19, 2030 DP U-1442
8562564 Jan 24, 2026 DP
8579865 Mar 19, 2030 DP U-1442
METHOTREXATE - OTREXUP
N 204824 002 6746429 Apr 12, 2020 DP
7744582 Aug 10, 2019 DP U-1442
7776015 Aug 10, 2019 DP
8021335 Oct 04, 2026 DP
8480631 Mar 19, 2030 DP U-1442
8562564 Jan 24, 2026 DP
8579865 Mar 19, 2030 DP U-1442
METHOTREXATE - OTREXUP
N 204824 003 6746429 Apr 12, 2020 DP
7744582 Aug 10, 2019 DP U-1442
7776015 Aug 10, 2019 DP
8021335 Oct 04, 2026 DP
8480631 Mar 19, 2030 DP U-1442
8562564 Jan 24, 2026 DP
8579865 Mar 19, 2030 DP U-1442
METHOTREXATE - OTREXUP
N 204824 004 6746429 Apr 12, 2020 DP
7744582 Aug 10, 2019 DP U-1442
7776015 Aug 10, 2019 DP
8021335 Oct 04, 2026 DP
8480631 Mar 19, 2030 DP U-1442
8562564 Jan 24, 2026 DP
8579865 Mar 19, 2030 DP U-1442
METHYL AMINOLEVULINATE HYDROCHLORIDE - METVIXIA
N 021415 001 6034267 Mar 08, 2016 U-804
METHYLNALTREXONE BROMIDE - RELISTOR
N 021964 001 6559158 Nov 03, 2017 U-1185
8247425 Dec 31, 2030 U-1185
8420663 Sep 30, 2029 U-1185
8552025 Apr 08, 2024 DP
METHYLNALTREXONE BROMIDE - RELISTOR
N 021964 002 6559158 Nov 03, 2017 U-1185
8247425 Dec 31, 2030 U-1185
8420663 Sep 30, 2029 U-1185
8552025 Apr 08, 2024 DP
METHYLNALTREXONE BROMIDE - RELISTOR
N 021964 003 8247425 Dec 31, 2030 U-1185
8420663 Sep 30, 2029 U-1185
8552025 Apr 08, 2024 DP
METHYLPHENIDATE - DAYTRANA
N 021514 001 6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
METHYLPHENIDATE - DAYTRANA
N 021514 002 6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
METHYLPHENIDATE - DAYTRANA
N 021514 003 6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
METHYLPHENIDATE - DAYTRANA
N 021514 004 6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 131 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N 021121 001 6919373
6930129
8163798
Jul 31, 2017
Jul 31, 2017
Jul 31, 2017
U-666
U-666
DP
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N 021121 002 6919373
6930129
8163798
Jul 31, 2017
Jul 31, 2017
Jul 31, 2017
U-666
U-666
DP
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N 021121 003 6919373
6930129
8163798
Jul 31, 2017
Jul 31, 2017
Jul 31, 2017
U-666
U-666
DP
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N 021121 004 6919373
6930129
8163798
Jul 31, 2017
Jul 31, 2017
Jul 31, 2017
U-666
U-666
DP
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N 021259 001 6344215 Oct 27, 2020 DP
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N 021259 002 6344215 Oct 27, 2020 DP
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N 021259 003 6344215 Oct 27, 2020 DP
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N 021259 004 6344215 Oct 27, 2020 DP
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N 021284 001 5837284
6228398
6635284
7431944
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
DP
DP U-472
DP U-591
DP
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N 021284 002 5837284
6228398
6635284
7431944
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
DP
DP U-472
DP U-591
DP
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N 021284 003 5837284
6228398
6635284
7431944
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
DP
DP U-472
DP U-591
DP
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N 021284 004 5837284
6228398
6635284
7431944
Dec 04, 2015
Nov 01, 2019
Dec 04, 2015
Dec 04, 2015
DP
DP U-472
DP U-591
DP
METHYLPHENIDATE HYDROCHLORIDE - METHYLIN
N 021419 001 7691880 Oct 07, 2024 DP
METHYLPHENIDATE HYDROCHLORIDE - METHYLIN
N 021419 002 7691880 Oct 07, 2024 DP
METHYLPHENIDATE HYDROCHLORIDE - QUILLIVANT XR
N 202100 001 8062667 Mar 29, 2029
8287903 Feb 15, 2031
8465765 Feb 15, 2031
8563033 Feb 15, 2031
DP
DP
DP U-1415
DP U-1415
NDF Sep 27, 2015
METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT
N 021793 001 6024981 Apr 09, 2018
6221392 Apr 09, 2018
METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT
DP
DP
N 021793 002 6024981
6221392
Apr 09, 2018
Apr 09, 2018
DP
DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 132 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT
N 022246 001 6413549 Jul 11, 2017 DP
METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT
N 022246 002 6413549 Jul 11, 2017 DP
METRONIDAZOLE - METRONIDAZOLE
A 090903 001 PC Dec 28, 2013
METRONIDAZOLE - METROGEL-VAGINAL
N 020208 001 5536743 Jul 16, 2013 U-137
METRONIDAZOLE - METROGEL
N 021789 001 6881726
7348317
Feb 21, 2022
Feb 21, 2022
DP U-743
DP U-743
METRONIDAZOLE - VANDAZOLE
N 021806 001 7456207 Sep 22, 2024 DP
MICAFUNGIN SODIUM - MYCAMINE
N 021506 002 6107458
6107458
6265536
6265536
6774104
6774104
Mar 16, 2019
Mar 16, 2019
Sep 29, 2015
Sep 29, 2015
Jan 08, 2021
Jan 08, 2021
DS DP U-650
DS DP U-845
DS DP U-650
DS DP U-845
DP U-650
DP U-845
MICAFUNGIN SODIUM - MYCAMINE
N 021506 003 6107458
6107458
6265536
6265536
6774104
6774104
Mar 16, 2019
Mar 16, 2019
Sep 29, 2015
Sep 29, 2015
Jan 08, 2021
Jan 08, 2021
DS DP U-650
DS DP U-845
DS DP U-650
DS DP U-845
DP U-650
DP U-845
MICONAZOLE - ORAVIG
N 022404 001 6916485
7651698
8518442
Sep 11, 2022
Sep 11, 2022
Sep 11, 2022
DP U-1051
U-1051
DP
MICONAZOLE NITRATE; MICONAZOLE NITRATE - MONISTAT 1 COMBINATION PACK
N 021308 001 5514698 Mar 21, 2014
6153635 Nov 28, 2020
Y
Y
MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE - VUSION
N 021026 001 8147852 Mar 30, 2028 U-1426
MIFEPRISTONE - KORLYM
N 202107 001 NP
ODE
Feb 17, 2015
Feb 17, 2019
MILNACIPRAN HYDROCHLORIDE - SAVELLA
N 022256 001 6602911 Jan 14, 2023
6992110 Nov 05, 2021
7888342 Nov 05, 2021
7994220 Sep 19, 2029
MILNACIPRAN HYDROCHLORIDE - SAVELLA
U-882
U-882
U-882
U-819
NCE Jan 14, 2014
N 022256 002 6602911 Jan 14, 2023
6992110 Nov 05, 2021
7888342 Nov 05, 2021
7994220 Sep 19, 2029
MILNACIPRAN HYDROCHLORIDE - SAVELLA
U-882
U-882
U-882
U-819
NCE Jan 14, 2014
N 022256 003 6602911 Jan 14, 2023
6992110 Nov 05, 2021
7888342 Nov 05, 2021
7994220 Sep 19, 2029
MILNACIPRAN HYDROCHLORIDE - SAVELLA
U-882
U-882
U-882
U-819
NCE Jan 14, 2014
N 022256 004 6602911
6992110
7888342
7994220
Jan 14, 2023
Nov 05, 2021
Nov 05, 2021
Sep 19, 2029
U-882
U-882
U-882
U-819
NCE Jan 14, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 133 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MINOCYCLINE HYDROCHLORIDE - ARESTIN
N 050781 001 6682348 Mar 29, 2022 DP
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 001 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 002 5908838 Feb 19, 2018 U-917
7541347 Apr 02, 2027 U-917
7544373 Apr 02, 2027 DP
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 003 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 004 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 005 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 006 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 007 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 008 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 134 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MINOCYCLINE HYDROCHLORIDE - XIMINO
N 201922 001 5908838
7541347
7544373
7790705
7919483
8252776
8268804
Feb 19, 2018
Apr 02, 2027
Apr 02, 2027
Jun 24, 2025
Mar 07, 2027
Jun 24, 2025
Jun 24, 2025
U-1376
U-917
DP
U-124
U-124
U-124
U-124
MINOCYCLINE HYDROCHLORIDE - XIMINO
N 201922 003 5908838
7541347
7544373
7790705
7919483
8252776
8268804
Feb 19, 2018
Apr 02, 2027
Apr 02, 2027
Jun 24, 2025
Mar 07, 2027
Jun 24, 2025
Jun 24, 2025
U-1376
U-917
DP
U-124
U-124
U-124
U-124
MINOCYCLINE HYDROCHLORIDE - XIMINO
N 201922 005 5908838
7541347
7544373
7790705
7919483
8252776
8268804
Feb 19, 2018
Apr 02, 2027
Apr 02, 2027
Jun 24, 2025
Mar 07, 2027
Jun 24, 2025
Jun 24, 2025
U-1376
U-917
DP
U-124
U-124
U-124
U-124
MINOXIDIL - MEN'S ROGAINE
N 021812 001 6946120 Apr 20, 2019 DP U-702
MIPOMERSEN SODIUM - KYNAMRO
N 203568 001 5914396
6166197
6222025
6451991
7015315
7101993
7407943
7511131
Jun 22, 2016
Dec 26, 2017
Mar 06, 2015
Feb 11, 2017
Mar 21, 2023
Sep 05, 2023
Aug 01, 2021
Dec 13, 2025
DS
DS
DS
DS
DS
DS
DS
U-1353
NCE
ODE
Jan 29, 2018
Jan 29, 2020
MIRABEGRON - MYRBETRIQ
N 202611 001 6346532
6562375
6699503
7342117
7750029
7982049
Oct 15, 2018
Aug 01, 2020
Sep 10, 2013
Nov 04, 2023
Dec 18, 2023
Nov 04, 2023
DS DP
DP
DP
DS
U-913
DP
NCE Jun 28, 2017
MIRABEGRON - MYRBETRIQ
N 202611 002 6346532
6562375
6699503
7342117
7750029
7982049
Oct 15, 2018
Aug 01, 2020
Sep 10, 2013
Nov 04, 2023
Dec 18, 2023
Nov 04, 2023
DS DP
DP
DP
DS
U-913
DP
NCE Jun 28, 2017
MITOMYCIN - MITOSOL
N 022572 001 7806265
8186511
Feb 01, 2029
Jul 19, 2026
DP
DP
ODE Feb 07, 2019
MODAFINIL - PROVIGIL
N 020717 001 7297346
RE37516
Nov 29, 2023
Oct 06, 2014
DP
U-255
MODAFINIL - PROVIGIL
N 020717 002 7297346
RE37516
Nov 29, 2023
Oct 06, 2014
DP
U-255
MOMETASONE FUROATE - ELOCON
N 019625 002 NP Apr 19, 2016
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 135 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MOMETASONE FUROATE - ASMANEX TWISTHALER
N 021067 001 5687710
5829434
5889015
6057307
6240918
6365581
6503537
6677322
6949532
8173172
Nov 18, 2014
Nov 03, 2015
Jan 27, 2014
Jan 27, 2014
Feb 20, 2017
Jan 27, 2014
Mar 17, 2018
Jan 27, 2014
Jan 27, 2014
Mar 17, 2018
DP
DP
U-645
DP U-645
DP
U-645
DP
U-645
U-645
DP
MOMETASONE FUROATE - ASMANEX TWISTHALER
N 021067 002 5687710
5829434
5889015
6057307
6240918
6365581
6503537
6677322
6949532
8173172
Nov 18, 2014
Nov 03, 2015
Jan 27, 2014
Jan 27, 2014
Feb 20, 2017
Jan 27, 2014
Mar 17, 2018
Jan 27, 2014
Jan 27, 2014
Mar 17, 2018
DP
DP
U-645
DP U-645
DP
U-645
DP
U-645
U-645
DP
MOMETASONE FUROATE MONOHYDRATE - NASONEX
N 020762 001 5837699
6127353
6723713
Jan 27, 2014
Oct 03, 2017
Jan 27, 2014
DP U-625
DS DP
U-625
M-99 Jan 19, 2014
MONTELUKAST SODIUM - SINGULAIR
N 020829 002 NPP Mar 26, 2015
MONTELUKAST SODIUM - SINGULAIR
N 020830 001 NPP Mar 26, 2015
MONTELUKAST SODIUM - SINGULAIR
N 020830 002 NPP Mar 26, 2015
MONTELUKAST SODIUM - SINGULAIR
N 021409 001 8007830 Oct 24, 2022 DP NPP Mar 26, 2015
MORPHINE SULFATE - AVINZA
N 021260 001 6066339 Nov 25, 2017
MORPHINE SULFATE - AVINZA
N 021260 002 6066339 Nov 25, 2017
MORPHINE SULFATE - AVINZA
N 021260 003 6066339 Nov 25, 2017
MORPHINE SULFATE - AVINZA
N 021260 004 6066339 Nov 25, 2017
MORPHINE SULFATE - AVINZA
N 021260 005 6066339 Nov 25, 2017 DP
MORPHINE SULFATE - AVINZA
N 021260 006 6066339 Nov 25, 2017 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 136 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
MORPHINE SULFATE - DEPODUR
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021671 001 5723147
5807572
5891467
5931809
5962016
5997899
6171613
6193998
6241999
MORPHINE SULFATE - DEPODUR
Mar 03, 2015
Sep 15, 2015
Jan 31, 2017
Jul 14, 2015
Jan 31, 2017
Sep 01, 2016
Oct 01, 2016
Sep 01, 2016
Sep 01, 2016
DP U-584
DP
DP
U-584
DP U-584
DP
DP
DP
DP
N 021671 002 5723147
5807572
5891467
5931809
5962016
5997899
6171613
6193998
6241999
MORPHINE SULFATE - DEPODUR
Mar 03, 2015
Sep 15, 2015
Jan 31, 2017
Jul 14, 2015
Jan 31, 2017
Sep 01, 2016
Oct 01, 2016
Sep 01, 2016
Sep 01, 2016
DP U-584
DP
DP
U-584
DP U-584
DP
DP
DP
DP
N 021671 003 5723147 Mar 03, 2015
5807572 Sep 15, 2015
5891467 Jan 31, 2017
5931809 Jul 14, 2015
5962016 Jan 31, 2017
5997899 Sep 01, 2016
6171613 Oct 01, 2016
6193998 Sep 01, 2016
6241999 Sep 01, 2016
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 001 7682633 Jun 19, 2027
7682634 Jun 19, 2027
7815934 Dec 12, 2027
8158156 Jun 19, 2027
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 002 7682633 Jun 19, 2027
7682634 Jun 19, 2027
7815934 Dec 12, 2027
8158156 Jun 19, 2027
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 003 7682633 Jun 19, 2027
7682634 Jun 19, 2027
7815934 Dec 12, 2027
8158156 Jun 19, 2027
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 004 7682633 Jun 19, 2027
7682634 Jun 19, 2027
7815934 Dec 12, 2027
8158156 Jun 19, 2027
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 005 7682633 Jun 19, 2027
7682634 Jun 19, 2027
7815934 Dec 12, 2027
8158156 Jun 19, 2027
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 006 7682633 Jun 19, 2027
7682634 Jun 19, 2027
7815934 Dec 12, 2027
8158156 Jun 19, 2027
MOXIFLOXACIN HYDROCHLORIDE - AVELOX
DP U-584
DP
DP
U-584
DP U-584
DP
DP
DP
DP
U-1241
DP
DP
U-1241
U-1241
DP
DP
U-1241
U-1241
DP
DP
U-1241
U-1241
DP
DP
U-1241
U-1241
DP
DP
U-1241
U-1241
DP
DP
U-1241
N 021085 001 5607942
5849752
Mar 04, 2014
Dec 05, 2016
U-298
U-298
6610327 Oct 29, 2019 DP U-298
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 137 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY
DATE CODES REQUESTED CODE(S)
MOXIFLOXACIN HYDROCHLORIDE - AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
N 021277 001 5607942 Mar 04, 2014 U-298
5849752 Dec 05, 2016 U-298
6548079 Jul 25, 2020 DP U-298
MOXIFLOXACIN HYDROCHLORIDE - VIGAMOX
N 021598 001 5607942 Mar 04, 2014 DS DP U-709
6716830 Sep 29, 2019 DP
7671070 Sep 29, 2019 U-709
MOXIFLOXACIN HYDROCHLORIDE - MOXEZA
N 022428 001 5607942 Mar 04, 2014 DS DP U-709 NP
6716830 Sep 29, 2019 DP PED
7671070 Sep 29, 2019 DP U-709
8450311 May 29, 2029 DP
MUPIROCIN - CENTANY
N 050788 001 6013657 Jul 08, 2018 DP
MUPIROCIN CALCIUM - BACTROBAN
N 050703 001 5569672 Oct 29, 2013 U-1358
MUPIROCIN CALCIUM - BACTROBAN
N 050746 001 5569672 Oct 29, 2013 U-1358
6025389 Oct 20, 2014 DP U-1122
MYCOPHENOLATE MOFETIL - CELLCEPT
N 050759 001 5688529 Nov 18, 2014 DP
MYCOPHENOLATE MOFETIL HYDROCHLORIDE - CELLCEPT
N 050758 001 5543408 Sep 15, 2013 DP
MYCOPHENOLIC ACID - MYFORTIC
N 050791 001 6025391 Apr 10, 2017 DP U-908
6172107 Apr 10, 2017 DP U-908
6306900 Feb 27, 2018 DP
MYCOPHENOLIC ACID - MYFORTIC
N 050791 002 6025391 Apr 10, 2017 DP U-908
6172107 Apr 10, 2017 DP U-908
6306900 Feb 27, 2018 DP
NAFTIFINE HYDROCHLORIDE - NAFTIN
N 019599 002 NS
NAFTIFINE HYDROCHLORIDE - NAFTIN
N 204286 001 NP
NALTREXONE - VIVITROL
N 021897 001 5792477 May 02, 2017 DP I-631
5916598 May 02, 2017 DP
6194006 Dec 30, 2018 DP
6264987 May 19, 2020 DP
6331317 Nov 12, 2019 DP
6379703 Dec 30, 2018 DP
6379704 May 19, 2020 DP
6395304 Nov 12, 2019 DP
6403114 May 02, 2017 DP
6495164 May 25, 2020 DP
6495166 Nov 12, 2019 DP
6534092 May 19, 2020 DP
6537586 Nov 12, 2019 DP
6596316 Dec 30, 2018 DP
6667061 May 25, 2020 DP
6713090 Nov 12, 2019 DP
6939033 Nov 12, 2019 DP
7799345 May 25, 2020 DP
7919499 Oct 15, 2029 U-1123
7919499 Oct 15, 2029 U-1124
EXCLUSIVITY
EXPIRATION
DATE
Nov 19, 2013
May 19, 2014
Jan 13, 2015
Jun 27, 2016
Oct 12, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 138 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NAPROXEN SODIUM - NAPRELAN
N 020353 001 5637320 Jun 10, 2014
NAPROXEN SODIUM - NAPRELAN
N 020353 002 5637320 Jun 10, 2014
NAPROXEN SODIUM - NAPRELAN
N 020353 003 5637320 Jun 10, 2014
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - TREXIMET
N 021926 001 6060499 Aug 14, 2017 DP U-867
6586458 Aug 14, 2017 DP U-867
7332183 Oct 02, 2025 DP U-867
8022095 Aug 14, 2017 DP U-867
NATEGLINIDE - STARLIX
N 021204 001 6559188 Sep 15, 2020 DP U-827
6641841 Nov 14, 2017 DP U-214
6844008 Nov 14, 2017 DP U-214
6878749 Sep 15, 2020 DP
NATEGLINIDE - STARLIX
N 021204 002 6559188 Sep 15, 2020 DP U-827
6641841 Nov 14, 2017 DP U-214
6844008 Nov 14, 2017 DP U-214
6878749 Sep 15, 2020 DP
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N 021742 002 5759580 Jun 02, 2015 DP
6545040 Dec 17, 2021 DP U-3
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N 021742 003 5759580 Jun 02, 2015 DP
6545040 Dec 17, 2021 DP U-3
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N 021742 004 5759580 Jun 02, 2015 DP
6545040 Dec 17, 2021 DP U-3
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N 021742 005 5759580 Jun 02, 2015 DP
6545040 Dec 17, 2021 DP U-3
NELARABINE - ARRANON
N 021877 001 5424295 Jun 13, 2017 DS DP
NELFINAVIR MESYLATE - VIRACEPT
N 020778 001 5484926 Oct 07, 2013
5952343 Oct 07, 2013 U-257
6162812 Oct 07, 2013 U-248
NELFINAVIR MESYLATE - VIRACEPT
N 020779 001 5484926 Oct 07, 2013
5952343 Oct 07, 2013 U-257
6162812 Oct 07, 2013 U-248
NELFINAVIR MESYLATE - VIRACEPT
N 021503 001 5484926 Oct 07, 2013
5952343 Oct 07, 2013 U-257
6162812 Oct 07, 2013 U-248
NEPAFENAC - NEVANAC
N 021862 001 5475034 Jun 06, 2014 U-100
7834059 Jan 31, 2027 U-1095
8071648 Dec 02, 2025 DP
8324281 Dec 02, 2025 DP
NEPAFENAC - ILEVRO
N 203491 001 5475034 Jun 06, 2014 U-100 NP Oct 16, 2015
6403609 Jul 17, 2018 DP
7947295 Jun 08, 2024 DP
NESIRITIDE RECOMBINANT - NATRECOR
N 020920 001 5114923 May 19, 2014 DS DP U-855
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 139 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
NEVIRAPINE - VIRAMUNE XR
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 201152 001 8460704
NEVIRAPINE - VIRAMUNE XR
Mar 12, 2029 U-1409 NDF
NPP
Mar 25, 2014
Nov 08, 2015
N 201152 002 NDF
NPP
Mar 25, 2014
Nov 08, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 140 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NIACIN - NIASPAN
N 020381 001 6080428 May 27, 2017 U-331
6129930 Sep 20, 2013 U-354
6406715 Sep 20, 2013 U-450
6746691 Sep 20, 2013 U-586
6818229 Feb 15, 2014 DP
7011848 Sep 20, 2013 U-712
NIACIN - NIASPAN
N 020381 002 6080428 May 27, 2017 U-331
6080428 May 27, 2017 U-1138
6080428 May 27, 2017 U-1139
6080428 May 27, 2017 U-1140
6080428 May 27, 2017 U-1141
6129930 Sep 20, 2013 DP U-354
6129930 Sep 20, 2013 DP U-1138
6129930 Sep 20, 2013 DP U-1139
6129930 Sep 20, 2013 DP U-1140
6129930 Sep 20, 2013 DP U-1141
6406715 Sep 20, 2013 DP U-450
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1142
6469035 Mar 15, 2018 U-1143
6469035 Mar 15, 2018 U-1144
6469035 Mar 15, 2018 U-1145
6676967 Sep 20, 2013 U-548
6676967 Sep 20, 2013 U-1138
6676967 Sep 20, 2013 U-1139
6676967 Sep 20, 2013 U-1140
6676967 Sep 20, 2013 U-1146
6746691 Sep 20, 2013 DP U-586
6818229 Sep 20, 2013 DP
7011848 Sep 20, 2013 U-712
7011848 Sep 20, 2013 U-1140
7011848 Sep 20, 2013 U-1141
7011848 Sep 20, 2013 U-1147
7011848 Sep 20, 2013 U-1148
7998506 Sep 20, 2013 U-1138
7998506 Sep 20, 2013 U-1139
7998506 Sep 20, 2013 U-1140
7998506 Sep 20, 2013 U-1141
NIACIN - NIASPAN
N 020381 003
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 141 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
7011848 Sep 20, 2013 U-1147
7011848 Sep 20, 2013 U-1148
7998506 Sep 20, 2013 U-1138
7998506 Sep 20, 2013 U-1139
7998506 Sep 20, 2013 U-1140
7998506 Sep 20, 2013 U-1141
NIACIN - NIASPAN
N 020381 004 6080428 May 27, 2017 U-331
6080428 May 27, 2017 U-1138
6080428 May 27, 2017 U-1139
6080428 May 27, 2017 U-1140
6080428 May 27, 2017 U-1141
6129930 Sep 20, 2013 DP U-354
6129930 Sep 20, 2013 DP U-1138
6129930 Sep 20, 2013 DP U-1139
6129930 Sep 20, 2013 DP U-1140
6129930 Sep 20, 2013 DP U-1141
6406715 Sep 20, 2013 DP U-450
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1142
6469035 Mar 15, 2018 U-1143
6469035 Mar 15, 2018 U-1144
6469035 Mar 15, 2018 U-1145
6676967 Sep 20, 2013 U-548
6676967 Sep 20, 2013 U-1138
6676967 Sep 20, 2013 U-1139
6676967 Sep 20, 2013 U-1140
6676967 Sep 20, 2013 U-1141
6676967 Sep 20, 2013 U-1146
6746691 Sep 20, 2013 DP U-586
6818229 Sep 20, 2013 DP
7011848 Sep 20, 2013 U-712
7011848 Sep 20, 2013 U-1140
7011848 Sep 20, 2013 U-1141
7011848 Sep 20, 2013 U-1147
7011848 Sep 20, 2013 U-1148
7998506 Sep 20, 2013 U-1138
7998506 Sep 20, 2013 U-1139
7998506 Sep 20, 2013 U-1140
7998506 Sep 20, 2013 U-1141
NIACIN - NIASPAN TITRATION STARTER PACK
N 020381 005 6080428 May 27, 2017 U-331
6129930 Sep 20, 2013 U-354
6406715 Sep 20, 2013 U-450
6746691 Sep 20, 2013 U-586
7011848 Sep 20, 2013 U-712
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 142 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NIACIN; SIMVASTATIN - SIMCOR
N 022078 001 6080428 May 27, 2017 U-862
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1134
6129930 Sep 20, 2013 DP U-862
6129930 Sep 20, 2013 DP U-1132
6129930 Sep 20, 2013 DP U-1134
6406715 Sep 20, 2013 DP
6469035 Mar 15, 2018 U-863
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1149
6676967 Sep 20, 2013 U-862
6676967 Sep 20, 2013 U-1132
6676967 Sep 20, 2013 U-1134
6746691 Sep 20, 2013 DP
6818229 Sep 20, 2013 DP
7011848 Sep 20, 2013 U-862
7011848 Sep 20, 2013 U-1150
7011848 Sep 20, 2013 U-1151
7998506 Sep 20, 2013 U-1150
7998506 Sep 20, 2013 U-1151
NIACIN; SIMVASTATIN - SIMCOR
N 022078 002 6080428 May 27, 2017 U-862
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1134
6129930 Sep 20, 2013 DP U-862
6129930 Sep 20, 2013 DP U-1132
6129930 Sep 20, 2013 DP U-1134
6406715 Sep 20, 2013 DP
6469035 Mar 15, 2018 U-863
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1149
6676967 Sep 20, 2013 U-862
6676967 Sep 20, 2013 U-1132
6676967 Sep 20, 2013 U-1134
6746691 Sep 20, 2013 DP
6818229 Sep 20, 2013 DP
7011848 Sep 20, 2013 U-862
7011848 Sep 20, 2013 U-1150
7011848 Sep 20, 2013 U-1151
7998506 Sep 20, 2013 U-1150
7998506 Sep 20, 2013 U-1151
NIACIN; SIMVASTATIN - SIMCOR
N 022078 003 6080428 May 27, 2017 U-862
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1134
6129930 Sep 20, 2013 DP U-862
6129930 Sep 20, 2013 DP U-1132
6129930 Sep 20, 2013 DP U-1134
6406715 Sep 20, 2013 DP
6469035 Mar 15, 2018 U-863
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1149
6676967 Sep 20, 2013 U-862
6676967 Sep 20, 2013 U-1132
6676967 Sep 20, 2013 U-1134
6746691 Sep 20, 2013 DP
6818229 Sep 20, 2013 DP
7011848 Sep 20, 2013 U-862
7011848 Sep 20, 2013 U-1150
7011848 Sep 20, 2013 U-1151
7998506 Sep 20, 2013 U-1150
7998506 Sep 20, 2013 U-1151
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 143 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NIACIN; SIMVASTATIN - SIMCOR
N 022078 004 6080428 May 27, 2017 U-862
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1134
6129930 Sep 20, 2013 DP U-862
6406715 Sep 20, 2013 DP
6469035 Mar 15, 2018 U-863
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1149
6676967 Sep 20, 2013 U-862
6676967 Sep 20, 2013 U-1132
6676967 Sep 20, 2013 U-1134
6746691 Sep 20, 2013 DP
6818229 Sep 20, 2013 DP
7011848 Sep 20, 2013 U-862
7011848 Sep 20, 2013 U-1150
7011848 Sep 20, 2013 U-1151
7998506 Sep 20, 2013 U-1150
7998506 Sep 20, 2013 U-1151
NIACIN; SIMVASTATIN - SIMCOR
N 022078 005 6080428 May 27, 2017 U-862
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1134
6129930 Sep 20, 2013 DP U-862
6406715 Sep 20, 2013 DP
6469035 Mar 15, 2018 U-863
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1149
6676967 Sep 20, 2013 U-862
6676967 Sep 20, 2013 U-1132
6676967 Sep 20, 2013 U-1134
6746691 Sep 20, 2013 DP
6818229 Sep 20, 2013 DP
7011848 Sep 20, 2013 U-862
7011848 Sep 20, 2013 U-1150
7011848 Sep 20, 2013 U-1151
7998506 Sep 20, 2013 U-1150
7998506 Sep 20, 2013 U-1151
NICARDIPINE HYDROCHLORIDE - CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
N 019734 002 7612102 Dec 26, 2027 DP
7659291 Apr 18, 2027 U-1029
8455524 Apr 18, 2027 U-1029
NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
N 019734 003 7612102 Dec 26, 2027 DP
7659291 Apr 18, 2027 U-1029
8455524 Apr 18, 2027 U-1029
NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
N 019734 004 7612102 Dec 26, 2027 DP
7659291 Apr 18, 2027 U-1029
8455524 Apr 18, 2027 U-1029
NICARDIPINE HYDROCHLORIDE - CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
N 019734 005 7612102 Dec 26, 2027 DP
7659291 Apr 18, 2027 U-1029
8455524 Apr 18, 2027 U-1029
NICOTINE - NICODERM CQ
N 020165 004 8075911 May 22, 2021 DP
NICOTINE - NICODERM CQ
N 020165 005 8075911 May 22, 2021 DP
NICOTINE - NICODERM CQ
N 020165 006 8075911 May 22, 2021 DP
NICOTINE - NICOTROL
N 020385 001 5656255 Aug 12, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 144 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NICOTINE POLACRILEX - NICORETTE
N 018612 002 8323683 Apr 30, 2028
NICOTINE POLACRILEX - NICORETTE
N 020066 002 8323683 Apr 30, 2028 DP
NICOTINE POLACRILEX - NICORETTE
N 022360 001 8501164 Jun 14, 2029 DP
NICOTINE POLACRILEX - NICORETTE
N 022360 002 8501164 Jun 14, 2029 DP
NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA
N 022068 001 7169791
8163904
8389537
8415363
8501760
Jul 04, 2023
Aug 23, 2028
Jul 18, 2026
Jul 18, 2026
Jul 18, 2026
DS DP U-836
DS DP
DS DP U-1374
DS DP U-1407
DS DP
ODE Oct 29, 2014
NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA
N 022068 002 7169791
8163904
8389537
8415363
8501760
Jul 04, 2023
Aug 23, 2028
Jul 18, 2026
Jul 18, 2026
Jul 18, 2026
DS DP U-836
DS DP
DS DP U-1374
DS DP U-1407
DS DP
I-627
ODE
Jun 17, 2014
Oct 29, 2014
NIMODIPINE - NYMALIZE
N 203340 001 ODE May 10, 2020
NISOLDIPINE - SULAR
N 020356 005 5626874 Nov 30, 2014 DP
NISOLDIPINE - SULAR
N 020356 006 5626874 Nov 30, 2014 DP
NISOLDIPINE - SULAR
N 020356 007 5626874 Nov 30, 2014 DP
NISOLDIPINE - SULAR
N 020356 008 5626874 Nov 30, 2014 DP
NITAZOXANIDE - ALINIA
N 021497 001 5578621
5968961
6020353
Nov 26, 2013
May 07, 2017
Sep 18, 2014
DP U-525
DP
DS DP
NITAZOXANIDE - ALINIA
N 021498 001 5578621
5965590
5968961
6020353
6117894
Sep 08, 2014
Jul 03, 2017
May 07, 2017
Sep 08, 2014
May 07, 2017
U-525
U-523
NITISINONE - ORFADIN
N 021232 001 5550165 Aug 27, 2013
NITISINONE - ORFADIN
N 021232 002 5550165 Aug 27, 2013
NITISINONE - ORFADIN
N 021232 003 5550165 Aug 27, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 145 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NITRIC OXIDE - INOMAX
N 020845 002 5558083
5732693
5752504
6125846
8282966
8291904
8293284
8431163
8431163*PED
8573209
8573209*PED
8573210
8573210*PED
Nov 22, 2013
Dec 13, 2016
Dec 13, 2016
May 16, 2017
Jun 30, 2029
Jan 06, 2031
Jun 30, 2029
Jun 30, 2029
Dec 30, 2029
Jan 06, 2031
Jul 06, 2031
Jan 06, 2031
Jul 06, 2031
DP U-1226
DP U-1230
DP U-1230
DP U-1457
U-1286
DP U-1226
U-1286
U-1286
DP
DP U-1453
NITRIC OXIDE - INOMAX
N 020845 003 5558083
5732693
5752504
6125846
8282966
8291904
8293284
8431163
8431163*PED
8573209
8573209*PED
8573210
8573210*PED
Nov 22, 2013
Dec 13, 2016
Dec 13, 2016
May 16, 2017
Jun 30, 2029
Jan 06, 2031
Jun 30, 2029
Jun 30, 2029
Dec 30, 2029
Jan 06, 2031
Jul 06, 2031
Jan 06, 2031
Jul 06, 2031
DP U-1226
DP U-1230
DP U-1230
DP U-1457
U-1286
DP U-1226
U-1286
U-1286
DP
DP U-1453
NITROGLYCERIN - NITROLINGUAL PUMPSPRAY
N 018705 002 7872049 Mar 14, 2028 DP U-39
NITROGLYCERIN - NITROSTAT
N 021134 001 6500456
NITROGLYCERIN - NITROSTAT
Sep 16, 2018
N 021134 002 6500456
NITROGLYCERIN - NITROSTAT
Sep 16, 2018
N 021134 003 6500456 Sep 16, 2018
NITROGLYCERIN - RECTIV
N 021359 001 7189761 May 27, 2014 DP U-1198 NP Jun 21, 2014
NITROGLYCERIN - NITROMIST
N 021780 001 5869082 Apr 16, 2016 DP
NIZATIDINE - AXID
N 021494 001 6930119 Jul 17, 2022 DP
OCTREOTIDE ACETATE - SANDOSTATIN
N 019667 001 5753618 May 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N 019667 002 5753618 May 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N 019667 003 5753618 May 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N 019667 004 5753618 May 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N 019667 005 5753618 May 19, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 146 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
PATENT
EXPIRATION
APPL/PROD
NO PATENT NO PATENT
PATENT
DELIST EXCLUSIVITY
EXCLUSIVITY
EXPIRATION
DATE
OCTREOTIDE ACETATE - SANDOSTATIN LAR
CODES REQUESTED CODE(S) DATE
N 021008 001 5538739 Jul 23, 2013
5639480 Jun 17, 2014
5688530 Nov 18, 2014
5922338 Jul 13, 2016
5922682 Jul 13, 2016
DP
DP
U-268
DP
DP
OCTREOTIDE ACETATE - SANDOSTATIN LAR
N 021008 002 5538739 Jul 23, 2013
5639480 Jun 17, 2014
5688530 Nov 18, 2014
5922338 Jul 13, 2016
5922682 Jul 13, 2016
DP
U-268
DP
DP
OCTREOTIDE ACETATE - SANDOSTATIN LAR
N 021008 003 5538739 Jul 23, 2013
5639480 Jun 17, 2014
5688530 Nov 18, 2014
5922338 Jul 13, 2016
5922682 Jul 13, 2016
DP
U-268
DP
DP
OLANZAPINE - ZYPREXA
N 020592 001 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA
N 020592 002 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA
N 020592 003 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA
N 020592 004 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA
N 020592 005 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA
N 020592 006 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA ZYDIS
N 021086 001 6960577 Nov 01, 2017 U-964 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA ZYDIS
N 021086 002 6960577 Nov 01, 2017 U-964 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA ZYDIS
N 021086 003 6960577 Nov 01, 2017 U-964 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA ZYDIS
N 021086 004 6960577 Nov 01, 2017 U-964 NPP Jul 26, 2016
OLANZAPINE PAMOATE - ZYPREXA RELPREVV
N 022173 001 6169084 Sep 30, 2018 DS DP U-1026
OLANZAPINE PAMOATE - ZYPREXA RELPREVV
N 022173 002 6169084 Sep 30, 2018 DS DP U-1026
OLANZAPINE PAMOATE - ZYPREXA RELPREVV
N 022173 003 6169084 Sep 30, 2018 DS DP U-1026
OLMESARTAN MEDOXOMIL - BENICAR
N 021286 001 5616599 Apr 25, 2016
6878703 Nov 19, 2021
DS DP U-500
U-3 Y
PED Aug 04, 2013
OLMESARTAN MEDOXOMIL - BENICAR
N 021286 003 5616599 Apr 25, 2016
6878703 Nov 19, 2021
DS DP U-500
U-3 Y
PED Aug 04, 2013
OLMESARTAN MEDOXOMIL - BENICAR
N 021286 004 5616599 Apr 25, 2016
6878703 Nov 19, 2021
DS DP U-500
U-3 Y
PED Aug 04, 2013
OLOPATADINE HYDROCHLORIDE - PATANOL
N 020688 001 5641805 Jun 06, 2015 U-184
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 147 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OLOPATADINE HYDROCHLORIDE - PATADAY
N 021545 001 5641805 Jun 06, 2015 U-765
6995186 Nov 12, 2023 DP U-765
7402609 Jun 19, 2022 DP
OLOPATADINE HYDROCHLORIDE - PATANASE
N 021861 001 7977376 Feb 02, 2023 DP
8399508 Sep 17, 2022 U-726
8399508*PED Mar 17, 2023
OMACETAXINE MEPESUCCINATE - SYNRIBO
N 203585 001 6987103 Jun 28, 2023 U-1300 NCE Oct 26, 2017
7842687 Mar 16, 2019 DS DP U-1299 ODE Oct 26, 2019
OMEGA-3-ACID ETHYL ESTERS - LOVAZA
N 021654 001 5656667 Apr 10, 2017 DS DP U-822
7732488 Jan 30, 2025 DS DP Y
OMEPRAZOLE - PRILOSEC
N 019810 001 6147103 Oct 09, 2018
6150380 Nov 10, 2018
6166213 Oct 09, 2018
6191148 Oct 09, 2018
OMEPRAZOLE - PRILOSEC
N 019810 002 6147103 Oct 09, 2018
6150380 Nov 10, 2018
6166213 Oct 09, 2018
6191148 Oct 09, 2018
OMEPRAZOLE - PRILOSEC
N 019810 003 6147103 Oct 09, 2018
6150380 Nov 10, 2018
6166213 Oct 09, 2018
6191148 Oct 09, 2018
OMEPRAZOLE MAGNESIUM - PRILOSEC OTC
N 021229 001 5690960 Nov 25, 2014
5753265 Jun 07, 2015
5817338 Oct 06, 2015
5900424 May 04, 2016
6403616 Nov 15, 2019
6428810 Nov 03, 2019
OMEPRAZOLE MAGNESIUM - PRILOSEC
N 022056 001 5690960 Nov 25, 2014 DP U-864
5900424 May 04, 2016 DS U-864
6428810 Nov 03, 2019 DP U-864
OMEPRAZOLE MAGNESIUM - PRILOSEC
N 022056 002 5690960 Nov 25, 2014 DP U-864
5900424 May 04, 2016 DS U-864
6428810 Nov 03, 2019 DP U-864
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 148 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021636 001 5840737
6489346
6645988
6699885
6780882
7399772
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
U-588
DS DP U-588
DS DP
U-588
DS DP
U-588
Y
Y
Y
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021636 002 5840737
5840737
6489346
6489346
6645988
6699885
6699885
6780882
7399772
7399772
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
U-623
U-624
DS DP U-623
DS DP U-624
DS DP
U-623
U-624
DS DP
U-623
U-624
Y
Y
Y
Y
Y
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021849 001 7399772 Jul 16, 2016 U-588
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021849 002 7399772 Jul 16, 2016 U-623
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID OTC
N 022281 001 6489346
6645988
6699885
7399772
Jul 15, 2016
Jul 15, 2016
Jul 15, 2016
Jul 15, 2016
DP U-1025
DP
DP
U-1025
Y
Y
Y
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID OTC
N 022283 001 5840737
6780882
7399772
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
U-1025
DP
U-1025
ONDANSETRON - ZOFRAN ODT
N 020781 001 5955488
6063802
Nov 14, 2015
Nov 14, 2015
ONDANSETRON - ZOFRAN ODT
N 020781 002 5955488
6063802
Nov 14, 2015
Nov 14, 2015
ONDANSETRON - ZUPLENZ
N 022524 001 8580830 Nov 23, 2029 DP
ONDANSETRON - ZUPLENZ
N 022524 002 8580830 Nov 23, 2029 DP
ONDANSETRON HYDROCHLORIDE - ZOFRAN
N 020605 001 5854270 Nov 20, 2015 DP U-44
ORLISTAT - XENICAL
N 020766 001 6004996 Jan 06, 2018
ORLISTAT - ALLI
N 021887 001 6004996 Jan 06, 2018 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 149 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OSELTAMIVIR PHOSPHATE - TAMIFLU
N 021087 001 5763483
5866601
5952375
Dec 27, 2016
Feb 02, 2016
Feb 27, 2015
DS U-1113
DS DP
DS DP
NPP Dec 21, 2015
OSELTAMIVIR PHOSPHATE - TAMIFLU
N 021087 002 5763483
5866601
5952375
Dec 27, 2016
Feb 02, 2016
Feb 27, 2015
DS U-1113
DS DP
DS DP
NPP Dec 21, 2015
OSELTAMIVIR PHOSPHATE - TAMIFLU
N 021087 003 5763483
5866601
5952375
Dec 27, 2016
Feb 02, 2016
Feb 27, 2015
DS U-1113
DS DP
DS DP
NPP Dec 21, 2015
OSELTAMIVIR PHOSPHATE - TAMIFLU
N 021246 001 5763483
5763483
5866601
5952375
Dec 27, 2016
Dec 27, 2016
Feb 02, 2016
Feb 27, 2015
DS U-376
DS U-1113
DS DP
DS DP
NPP Dec 21, 2015
OSELTAMIVIR PHOSPHATE - TAMIFLU
N 021246 002 5763483
5866601
5952375
Dec 27, 2016
Feb 02, 2016
Feb 27, 2015
DS DP U-1113
DS DP
DS DP
NPP Dec 21, 2015
OSPEMIFENE - OSPHENA
N 203505 001 6245819
8236861
8236861
8470890
8470890
Jul 21, 2020
Aug 11, 2026
Aug 11, 2026
Feb 13, 2024
Feb 13, 2024
U-1369
U-1369
U-1370
U-1369
U-1370
NCE Feb 26, 2018
OXALIPLATIN - ELOXATIN
N 021492 001 5420319
OXALIPLATIN - ELOXATIN
Aug 09, 2016 DS
N 021492 002 5420319
OXALIPLATIN - ELOXATIN
Aug 09, 2016 DS
N 021759 001 5420319
5716988
OXALIPLATIN - ELOXATIN
Aug 09, 2016
Aug 07, 2015
DS
DP
N 021759 002 5420319
5716988
OXALIPLATIN - ELOXATIN
Aug 09, 2016
Aug 07, 2015
DS
DP
N 021759 003 5420319
5716988
OXANDROLONE - OXANDRIN
Aug 09, 2016
Aug 07, 2015
DS
DP
N 013718 001 5872147
6090799
6576659
6828313
Dec 05, 2017
Jul 18, 2017
Dec 05, 2017
Dec 05, 2017
U-585
U-585
U-585
U-585
OXANDROLONE - OXANDRIN
N 013718 002 5872147
6090799
6576659
6828313
Dec 05, 2017
Jul 18, 2017
Dec 05, 2017
Dec 05, 2017
U-585
U-585
U-585
U-585
OXCARBAZEPINE - TRILEPTAL
N 021014 001 7037525 Feb 12, 2018 U-724
OXCARBAZEPINE - TRILEPTAL
N 021014 002 7037525 Feb 12, 2018 U-724
OXCARBAZEPINE - TRILEPTAL
N 021014 003 7037525 Feb 12, 2018 U-724
OXCARBAZEPINE - TRILEPTAL
N 021285 001 7037525
8119148
Feb 12, 2018
Dec 19, 2020
U-724
DP U-724
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 150 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OXCARBAZEPINE - OXTELLAR XR
N 202810 001 7722898 Apr 13, 2027 DP NDF Oct 19, 2015
7910131 Apr 13, 2027 U-1298
8617600 Apr 13, 2027 DP
OXCARBAZEPINE - OXTELLAR XR
N 202810 002 7722898 Apr 13, 2027 DP NDF Oct 19, 2015
7910131 Apr 13, 2027 U-1298
8617600 Apr 13, 2027 DP
OXCARBAZEPINE - OXTELLAR XR
N 202810 003 7722898 Apr 13, 2027 DP NDF Oct 19, 2015
7910131 Apr 13, 2027 U-1298
8617600 Apr 13, 2027 DP
OXYBUTYNIN - OXYTROL
N 021351 002 5601839 Apr 26, 2015
5834010 Apr 26, 2015
6743441 Apr 26, 2020 DP U-318
7081249 Apr 26, 2020 DP U-318
7081250 Apr 26, 2020 DP U-318
7081251 Apr 26, 2020 DP U-318
7081252 Apr 26, 2020 DP U-318
7179483 Apr 26, 2020 DS DP U-318
OXYBUTYNIN - OXYTROL FOR WOMEN
N 202211 001 5601839 Apr 26, 2015 DP U-1329 NP Jan 25, 2016
5834010 Apr 26, 2015 DP U-1329
6743441 Apr 26, 2020 DP U-1329
7081249 Apr 26, 2020 DP U-1329
7081250 Apr 26, 2020 DP U-1329
7081251 Apr 26, 2020 DP U-1329
7081252 Apr 26, 2020 DP U-1329
7179483 Apr 26, 2020 U-1329
OXYBUTYNIN - GELNIQUE 3%
N 202513 001 7029694 Apr 26, 2020 DP U-318 NP Dec 07, 2014
7179483 Apr 26, 2020 U-318
7198801 Jun 25, 2022 DP
8241662 Apr 26, 2020 U-318
OXYBUTYNIN CHLORIDE - DITROPAN XL
N 020897 001 5674895 May 22, 2015
5840754 May 22, 2015
5912268 May 22, 2015
6262115 May 22, 2015 U-393
OXYBUTYNIN CHLORIDE - DITROPAN XL
N 020897 002 5674895 May 22, 2015
5840754 May 22, 2015
5912268 May 22, 2015
6262115 May 22, 2015 U-393
OXYBUTYNIN CHLORIDE - DITROPAN XL
N 020897 003 5674895 May 22, 2015
5840754 May 22, 2015
5912268 May 22, 2015
6262115 May 22, 2015 U-393
OXYBUTYNIN CHLORIDE - GELNIQUE
N 022204 001 7029694 Apr 26, 2020 DP U-318
7179483 Apr 26, 2020 U-318
8241662 Apr 26, 2020 U-318
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 151 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 001 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-443
8337888 Aug 06, 2022 DP
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 002 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-443
8337888 Aug 06, 2022 DP
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 003 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-443
8337888 Aug 06, 2022 DP
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 004 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-443
8337888 Aug 06, 2022 DP
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 005 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-443
8337888 Aug 06, 2022 DP
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 006 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-443
8337888 Aug 06, 2022 DP
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 007 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-443
8337888 Aug 06, 2022 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 152 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OXYCODONE HYDROCHLORIDE - OXECTA
N 202080 001 7201920
7510726
7981439
8409616
Mar 16, 2025
Nov 26, 2023
Nov 26, 2023
Nov 26, 2023
DP
DP
DP
DP
OXYCODONE HYDROCHLORIDE - OXECTA
N 202080 002 7201920
7510726
7981439
8409616
Mar 16, 2025
Nov 26, 2023
Nov 26, 2023
Nov 26, 2023
DP
DP
DP
DP
OXYMORPHONE HYDROCHLORIDE - OXYMORPHONE HYDROCHLORIDE
A 079087 001 PC Jul 07, 2013
OXYMORPHONE HYDROCHLORIDE - OXYMORPHONE HYDROCHLORIDE
A 079087 003 PC Jul 07, 2013
OXYMORPHONE HYDROCHLORIDE - OXYMORPHONE HYDROCHLORIDE
A 079087 005 PC Jul 02, 2013
OXYMORPHONE HYDROCHLORIDE - OXYMORPHONE HYDROCHLORIDE
A 079087 006 PC Jul 07, 2013
OXYMORPHONE HYDROCHLORIDE - OXYMORPHONE HYDROCHLORIDE
A 079087 007 PC Jul 07, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 153 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 001 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 002 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 003 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 004 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 005 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 006 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 007 5662933 Sep 09, 2013 DP
5958456 Sep 09, 2013 DP
7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 001 7851482 Jul 10, 2029 DS
8075872 Nov 20, 2023 DP
8114383 Aug 08, 2024 DP
8192722 Sep 15, 2025 DP
8309060 Nov 20, 2023 DP
8309122 Feb 04, 2023 DP
8329216 Feb 04, 2023 DP
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 002 7851482 Jul 10, 2029 DS
8075872 Nov 20, 2023 DP
8114383 Aug 08, 2024 DP
8192722 Sep 15, 2025 DP
8309060 Nov 20, 2023 DP
8309122 Feb 04, 2023 DP
8329216 Feb 04, 2023 DP
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 003 7851482 Jul 10, 2029 DS
8075872 Nov 20, 2023 DP
8114383 Aug 08, 2024 DP
8192722 Sep 15, 2025 DP
8309060 Nov 20, 2023 DP
8309122 Feb 04, 2023 DP
8329216 Feb 04, 2023 DP
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 004 7851482 Jul 10, 2029 DS
8075872 Nov 20, 2023 DP
8114383 Aug 08, 2024 DP
8192722 Sep 15, 2025 DP
8309060 Nov 20, 2023 DP
8309122 Feb 04, 2023 DP
8329216 Feb 04, 2023 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 154 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
APPL/PROD
NO PATENT NO
OXYMORPHONE HYDROCHLORIDE - OPANA ER
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 201655 005 7851482
8075872
8114383
8192722
8309060
8309122
8329216
Jul 10, 2029
Nov 20, 2023
Aug 08, 2024
Sep 15, 2025
Nov 20, 2023
Feb 04, 2023
Feb 04, 2023
DS
DP
DP
DP
DP
DP
DP
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 006 7851482
8075872
8114383
8192722
8309060
8309122
8329216
Jul 10, 2029
Nov 20, 2023
Aug 08, 2024
Sep 15, 2025
Nov 20, 2023
Feb 04, 2023
Feb 04, 2023
DS
DP
DP
DP
DP
DP
DP
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 007 7851482
8075872
8114383
8192722
8309060
8309122
8329216
Jul 10, 2029
Nov 20, 2023
Aug 08, 2024
Sep 15, 2025
Nov 20, 2023
Feb 04, 2023
Feb 04, 2023
DS
DP
DP
DP
DP
DP
DP
PACLITAXEL - ABRAXANE
N 021660 001 7758891
7820788
7820788
7820788
7923536
7923536
7923536
8034375
8138229
8138229
8138229
8268348
8314156
8314156
RE41884
RE41884
RE41884
Feb 21, 2026
Mar 03, 2024
Mar 03, 2024
Mar 03, 2024
Dec 09, 2023
Dec 09, 2023
Dec 09, 2023
Aug 13, 2026
Dec 09, 2023
Dec 09, 2023
Dec 09, 2023
Feb 21, 2026
Dec 09, 2023
Dec 09, 2023
Aug 14, 2016
Aug 14, 2016
Aug 14, 2016
U-1434
DP U-1092
DP U-1290
DP U-1434
U-1117
U-1290
U-1434
U-1290
DP U-1092
DP U-1290
DP U-1434
U-1290
U-1290
U-1434
U-1117
U-1290
U-1434
I-658
I-676
ODE
Oct 11, 2015
Sep 06, 2016
Sep 06, 2020
PALIPERIDONE - INVEGA
N 021999 001 NPP
PED
Apr 06, 2014
Oct 06, 2014
PALIPERIDONE - INVEGA
N 021999 002 NPP
PED
Apr 06, 2014
Oct 06, 2014
PALIPERIDONE - INVEGA
N 021999 003 NPP
PED
Apr 06, 2014
Oct 06, 2014
PALIPERIDONE - INVEGA
N 021999 004 NPP
PED
Apr 06, 2014
Oct 06, 2014
PALIPERIDONE - INVEGA
N 021999 006 NPP
PED
Apr 06, 2014
Oct 06, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 155 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N 022264 001 5254556 Oct 15, 2013 DS DP U-543 M-119 Aug 29, 2015
6077843 May 12, 2017 DP U-543
6555544 Nov 10, 2018 DP U-543
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N 022264 002 5254556 Oct 15, 2013 DS DP U-543 M-119 Aug 29, 2015
6077843 May 12, 2017 DP U-543
6555544 Nov 10, 2018 DP U-543
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N 022264 003 5254556 Oct 15, 2013 DS DP U-543 M-119 Aug 29, 2015
6077843 May 12, 2017 DP U-543
6555544 Nov 10, 2018 DP U-543
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N 022264 004 5254556 Oct 15, 2013 DS DP U-543 M-119 Aug 29, 2015
6077843 May 12, 2017 DP U-543
6555544 Nov 10, 2018 DP U-543
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N 022264 005 5254556 Oct 15, 2013 DS DP U-543 M-119 Aug 29, 2015
6077843 May 12, 2017 DP U-543
6555544 Nov 10, 2018 DP U-543
PALONOSETRON HYDROCHLORIDE - ALOXI
N 021372 001 5202333 Apr 13, 2015 DS DP U-528
7947724 Jan 30, 2024 DP
7947725 Jan 30, 2024 DP
7960424 Jan 30, 2024 DP
8518981 Jan 30, 2024 DP
8598218 Jan 30, 2024 DP
8598219 Jan 30, 2024 DP
PALONOSETRON HYDROCHLORIDE - ALOXI
N 021372 002 5202333 Apr 13, 2015 DS DP U-901
7947724 Jan 30, 2024 DP
7947725 Jan 30, 2024 DP
7960424 Jan 30, 2024 DP
8518981 Jan 30, 2024 DP
8598218 Jan 30, 2024 DP
8598219 Jan 30, 2024 DP
PALONOSETRON HYDROCHLORIDE - ALOXI
N 022233 001 5202333 Apr 13, 2015 DS DP U-528
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PERTZYE
N 022175 001 NCE May 17, 2017
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PERTZYE
N 022175 002 NCE May 17, 2017
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - CREON
N 020725 001 M-93 Jul 29, 2013
NCE Apr 30, 2014
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - CREON
N 020725 002 M-93 Jul 29, 2013
NCE Apr 30, 2014
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - CREON
N 020725 003 M-93 Jul 29, 2013
NCE Apr 30, 2014
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - CREON
N 020725 004 M-93 Jul 29, 2019
NCE Apr 30, 2014
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - CREON
N 020725 005 M-93 Jul 29, 2019
NCE Apr 30, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 156 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 001 7658918 Feb 20, 2028 DP NCE
8221747 Feb 20, 2028 DP
8246950 Feb 20, 2028 U-1274
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP
8562980 Feb 20, 2028 DP
8562981 Feb 20, 2028
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 002 7658918 Feb 20, 2028 DP NCE
8221747 Feb 20, 2028 DP
8246950 Feb 20, 2028 U-1274
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP
8562980 Feb 20, 2028 DP
8562981 Feb 20, 2028
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 003 7658918 Feb 20, 2028 DP NCE
8221747 Feb 20, 2028 DP
8246950 Feb 20, 2028 U-1274
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP
8562980 Feb 20, 2028 DP
8562981 Feb 20, 2028
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 004 7658918 Feb 20, 2028 DP NCE
8221747 Feb 20, 2028 DP
8246950 Feb 20, 2028 U-1274
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP
8562980 Feb 20, 2028 DP
8562981 Feb 20, 2028
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 005 8221747 Feb 20, 2028 DP NCE
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP
8562980 Feb 20, 2028 DP
8562981 Feb 20, 2028
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 006 8221747 Feb 20, 2028 DP NCE
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP
8562980 Feb 20, 2028 DP
8562981 Feb 20, 2028
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ULTRESA
N 022222 001 NCE
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ULTRESA
N 022222 002 NCE
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ULTRESA
N 022222 003 NCE
Aug 27, 2014
Aug 27, 2014
Aug 27, 2014
Aug 27, 2014
Aug 27, 2014
Aug 27, 2014
Mar 01, 2017
Mar 01, 2017
Mar 01, 2017
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 157 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - PANCREAZE
N 022523 001 NCE Apr 12, 2015
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - PANCREAZE
N 022523 002 NCE Apr 12, 2015
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - PANCREAZE
N 022523 003 NCE Apr 12, 2015
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - PANCREAZE
N 022523 004 NCE Apr 12, 2015
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - VIOKACE
N 022542 001 NCE Mar 01, 2017
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - VIOKACE
N 022542 002 NCE Mar 01, 2017
PANTOPRAZOLE SODIUM - PROTONIX
N 020987 001 5997903 Dec 07, 2016
PANTOPRAZOLE SODIUM - PROTONIX
N 020987 002 5997903 Dec 07, 2016
PANTOPRAZOLE SODIUM - PROTONIX IV
N 020988 001 6780881 Nov 17, 2021 DP
7351723 Nov 17, 2021 DP
PANTOPRAZOLE SODIUM - PROTONIX
N 022020 001 7544370 Jun 07, 2026 DP
7550153 Sep 30, 2024 U-859
7553498 Sep 30, 2024 U-859
7838027 Sep 30, 2024 DP U-859
PARICALCITOL - PARICALCITOL
A 090829 001 PC Dec 24, 2013
PARICALCITOL - PARICALCITOL
A 090829 002 PC Dec 24, 2013
PARICALCITOL - PARICALCITOL
A 090829 003 PC Dec 24, 2013
PARICALCITOL - ZEMPLAR
N 020819 001 5587497 Dec 24, 2013
5597815 Jul 13, 2015 U-1195
6136799 Apr 08, 2018
6361758 Apr 08, 2018 DP
PARICALCITOL - ZEMPLAR
N 020819 002 5587497 Dec 24, 2013
5597815 Jul 13, 2015 U-1195
6136799 Apr 08, 2018
6361758 Apr 08, 2018 DP
PARICALCITOL - ZEMPLAR
N 021606 001 5587497 Dec 24, 2013 DS
5597815 Jul 13, 2015 U-1195
PARICALCITOL - ZEMPLAR
N 021606 002 5587497 Dec 24, 2013 DS
5597815 Jul 13, 2015 U-1195
PARICALCITOL - ZEMPLAR
N 021606 003 5587497 Dec 24, 2013 DS
5597815 Jul 13, 2015 U-1195
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 158 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PAROXETINE HYDROCHLORIDE - PAXIL
N 020031 001 5872132 May 19, 2015
5900423 May 19, 2015
6113944 Dec 14, 2014
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020031 002 5872132 May 19, 2015
5900423 May 19, 2015
6113944 Dec 14, 2014
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020031 003 5872132 May 19, 2015
5900423 May 19, 2015
6113944 Dec 14, 2014
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020031 004 5872132 May 19, 2015
5900423 May 19, 2015
6113944 Dec 14, 2014
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020031 005 5872132 May 19, 2015
5900423 May 19, 2015
6113944 Dec 14, 2014
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020710 001 5811436 Sep 22, 2015
5872132 May 19, 2015
5900423 May 19, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020885 001 5872132 May 19, 2015
5900423 May 19, 2015
6063927 Apr 23, 2019
6080759 May 19, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
6172233 Jan 15, 2018
PAROXETINE HYDROCHLORIDE - PAXIL
N 020885 002 5872132 May 19, 2015
5900423 May 19, 2015
6063927 Apr 23, 2019
6080759 May 19, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
6172233 Jan 15, 2018
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 159 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PAROXETINE HYDROCHLORIDE - PAXIL
N 020885 003 5872132 May 19, 2015
5900423 May 19, 2015
6063927 Apr 23, 2019
6080759 May 19, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
6172233 Jan 15, 2018
PAROXETINE HYDROCHLORIDE - PAXIL
N 020885 004 5872132 May 19, 2015
5900423 May 19, 2015
6063927 Apr 23, 2019
6080759 May 19, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
6172233 Jan 15, 2018
PAROXETINE HYDROCHLORIDE - PAXIL CR
N 020936 001 5872132 May 19, 2015
5900423 May 19, 2015
6121291 Mar 17, 2017 U-286
6133289 May 19, 2015 U-286
6548084 Jul 19, 2016
7229640 Jul 19, 2016 DP U-816
PAROXETINE HYDROCHLORIDE - PAXIL CR
N 020936 002 5872132 May 19, 2015
5900423 May 19, 2015
6121291 Mar 17, 2017 U-286
6133289 May 19, 2015 U-286
6548084 Jul 19, 2016
7229640 Jul 19, 2016 DP U-816
PAROXETINE HYDROCHLORIDE - PAXIL CR
N 020936 003 5872132 May 19, 2015
5900423 May 19, 2015
6121291 Mar 17, 2017 U-286
6133289 May 19, 2015 U-286
6548084 Jul 19, 2016
7229640 Jul 19, 2016 DP U-816
PAROXETINE MESYLATE - PEXEVA
N 021299 001 5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-286
5874447 Jun 10, 2017 U-518
7598271 Feb 12, 2023 DS DP
PAROXETINE MESYLATE - PEXEVA
N 021299 002 5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-286
5874447 Jun 10, 2017 U-518
7598271 Feb 12, 2023 DS DP
PAROXETINE MESYLATE - PEXEVA
N 021299 003 5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-286
5874447 Jun 10, 2017 U-518
7598271 Feb 12, 2023 DS DP
PAROXETINE MESYLATE - PEXEVA
N 021299 004 5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-286
5874447 Jun 10, 2017 U-518
7598271 Feb 12, 2023 DS DP
PAROXETINE MESYLATE - BRISDELLE
N 204516 001 5874447 Jun 10, 2017 DS NP Jun 28, 2016
7598271 Feb 12, 2023 DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 160 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
PATENT
EXPIRATION
APPL/PROD
NO PATENT NO PATENT
PATENT
DELIST
DATE CODES REQUESTED
PASIREOTIDE DIASPARTATE - SIGNIFOR
N 200677 001 6225284 Jun 28, 2016 DS DP
7473761 Jul 29, 2025 DS DP
8299209 Dec 27, 2025 DS DP
PASIREOTIDE DIASPARTATE - SIGNIFOR
N 200677 002 6225284 Jun 28, 2016 DS DP
7473761 Jul 29, 2025 DS DP
8299209 Dec 27, 2025 DS DP
PASIREOTIDE DIASPARTATE - SIGNIFOR
N 200677 003 6225284 Jun 28, 2016 DS DP
7473761 Jul 29, 2025 DS DP
8299209 Dec 27, 2025 DS DP
PAZOPANIB HYDROCHLORIDE - VOTRIENT
N 022465 001 7105530 Oct 19, 2023 DS DP
7262203 Dec 19, 2021 DS DP
8114885 Dec 19, 2021 DS DP
PAZOPANIB HYDROCHLORIDE - VOTRIENT
N 022465 002 7105530 Oct 19, 2023 DS DP
7262203 Dec 19, 2021 DS DP
8114885 Dec 19, 2021 DS DP
PEGAPTANIB SODIUM - MACUGEN
N 021756 001 5919455 Oct 27, 2013 DS
5932462 Aug 03, 2016
6011020 Jan 04, 2017
DS
DS
6051698 May 19, 2015
6113906 Oct 27, 2013
DS U-622
DS
EXCLUSIVITY
EXCLUSIVITY EXPIRATION
CODE(S) DATE
NCE Dec 14, 2017
ODE Dec 14, 2019
NCE Dec 14, 2017
ODE Dec 14, 2019
NCE Dec 14, 2017
ODE Dec 14, 2019
I-649 Apr 26, 2015
NCE Oct 19, 2014
ODE Apr 26, 2019
I-649 Apr 26, 2015
NCE Oct 19, 2014
ODE Apr 26, 2019
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 161 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 001 7084245
7414105
7528104
7550433
7919118
7919461
May 12, 2024
May 12, 2024
May 12, 2024
Jun 02, 2026
May 12, 2024
Jun 02, 2026
DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238
NCE Mar 27, 2017
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 002 7084245
7414105
7528104
7550433
7919118
7919461
May 12, 2024
May 12, 2024
May 12, 2024
Jun 02, 2026
May 12, 2024
Jun 02, 2026
DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238
NCE Mar 27, 2017
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 003 7084245
7414105
7528104
7550433
7919118
7919461
May 12, 2024
May 12, 2024
May 12, 2024
Jun 02, 2026
May 12, 2024
Jun 02, 2026
DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238
NCE Mar 27, 2017
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 004 7084245
7414105
7528104
7550433
7919118
7919461
May 12, 2024
May 12, 2024
May 12, 2024
Jun 02, 2026
May 12, 2024
Jun 02, 2026
DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238
NCE Mar 27, 2017
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 005 7084245
7414105
7528104
7550433
7919118
7919461
May 12, 2024
May 12, 2024
May 12, 2024
Jun 02, 2026
May 12, 2024
Jun 02, 2026
DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238
NCE Mar 27, 2017
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 006 7084245
7414105
7528104
7550433
7919118
7919461
May 12, 2024
May 12, 2024
May 12, 2024
Jun 02, 2026
May 12, 2024
Jun 02, 2026
DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238
NCE Mar 27, 2017
PEGINESATIDE ACETATE - OMONTYS
N 202799 007 7084245
7414105
7528104
7550433
7919118
7919461
May 12, 2024
May 12, 2024
May 12, 2024
Jun 02, 2026
May 12, 2024
Jun 02, 2026
DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238
PEGINESATIDE ACETATE - OMONTYS
N 202799 008 7084245
7414105
7528104
7550433
7919118
7919461
May 12, 2024
May 12, 2024
May 12, 2024
Jun 02, 2026
May 12, 2024
Jun 02, 2026
DS DP U-1238
DS DP U-1238
DS DP
U-1238
DS DP
U-1238
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 162 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PEGVISOMANT - SOMAVERT
N 021106 001 5849535 Mar 25, 2017 DS
6057292 Sep 21, 2015 U-507
PEGVISOMANT - SOMAVERT
N 021106 002 5849535 Mar 25, 2017 DS
6057292 Sep 21, 2015 U-507
PEGVISOMANT - SOMAVERT
N 021106 003 5849535 Mar 25, 2017 DS
6057292 Sep 21, 2015 U-507
PEMETREXED DISODIUM - ALIMTA
N 021462 001 5344932 Jul 24, 2016 DS DP M-122 Oct 17, 2015
7772209 Nov 24, 2021 U-1077 M-61 Mar 17, 2014
7772209 Nov 24, 2021 U-1296 PED Sep 17, 2014
PEMETREXED DISODIUM - ALIMTA
N 021462 002 5344932 Jul 24, 2016 DS DP M-122 Oct 17, 2015
7772209 Nov 24, 2021 U-1296 M-61 Mar 17, 2014
PED Sep 17, 2014
PENCICLOVIR SODIUM - DENAVIR
N 020629 001 5840763 Sep 01, 2015 U-501
5866581 Oct 04, 2014 U-501
5916893 Sep 01, 2015 U-501
6124304 Oct 04, 2014 U-501
6469015 Oct 22, 2019 U-501
6579981 Jun 17, 2020 U-501
PERAMPANEL - FYCOMPA
N 202834 001 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
PERAMPANEL - FYCOMPA
N 202834 002 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
PERAMPANEL - FYCOMPA
N 202834 003 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
PERAMPANEL - FYCOMPA
N 202834 004 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
PERAMPANEL - FYCOMPA
N 202834 005 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
PERAMPANEL - FYCOMPA
N 202834 006 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE - SKIN EXPOSURE REDUCTION PASTE AGAINST
CHEMICAL WARFARE AGENTS
N 021084 001 5607979 May 30, 2015
PERFLUTREN - DEFINITY
N 021064 001 5527521 Feb 22, 2015 DP U-665
5585112 Dec 17, 2013 DP
6033645 Jun 19, 2016 U-665
PHENTERMINE HYDROCHLORIDE - SUPRENZA
N 202088 001 6149938 Jul 23, 2018 DP
8440170 Mar 14, 2029 DP
PHENTERMINE HYDROCHLORIDE - SUPRENZA
N 202088 002 6149938 Jul 23, 2018 DP
8440170 Mar 14, 2029 DP
PHENTERMINE HYDROCHLORIDE - SUPRENZA
N 202088 003 6149938 Jul 23, 2018 DP U-1243
8440170 Mar 14, 2029 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 163 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA
N 022580 001 7056890 Jun 14, 2020 DP U-1262 NC Jul 17, 2015
7553818 Jun 14, 2020 U-1262
7659256 Jun 14, 2020 DP U-1262
7674776 Jun 14, 2020 DP U-1262
8580298 May 15, 2029 DP
8580299 Jun 14, 2029 U-1262
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA
N 022580 002 7056890 Jun 14, 2020 DP U-1262 NC Jul 17, 2015
7553818 Jun 14, 2020 U-1262
7659256 Jun 14, 2020 DP U-1262
7674776 Jun 14, 2020 DP U-1262
8580298 May 15, 2029 DP
8580299 Jun 14, 2029 U-1262
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA
N 022580 003 7056890 Jun 14, 2020 DP U-1262 NC Jul 17, 2015
7553818 Jun 14, 2020 U-1262
7659256 Jun 14, 2020 DP U-1262
7674776 Jun 14, 2020 DP U-1262
8580298 May 15, 2029 DP
8580299 Jun 14, 2029 U-1262
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA
N 022580 004 7056890 Jun 14, 2020 DP U-1262 NC Jul 17, 2015
7553818 Jun 14, 2020 U-1262
7659256 Jun 14, 2020 DP U-1262
7674776 Jun 14, 2020 DP U-1262
8580298 May 15, 2029 DP
8580299 Jun 14, 2029 U-1262
PHENTOLAMINE MESYLATE - ORAVERSE
N 022159 001 6764678 May 11, 2021 U-967
6872390 May 11, 2021 DP
7229630 Jun 20, 2023 DP
7569230 Oct 17, 2023 U-967
7575757 Apr 21, 2025 DP
PIMECROLIMUS - ELIDEL
N 021302 001 5912238 Jun 15, 2016
6352998 Oct 26, 2015
6423722 Jun 26, 2018
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 164 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PIOGLITAZONE HYDROCHLORIDE - ACTOS
N 021073 001 5965584 Jun 19, 2016 U-753
6150383 Jun 19, 2016 U-418
6150384 Jun 19, 2016 U-419
6166042 Jun 19, 2016 U-414
6166043 Jun 19, 2016 U-415
6172090 Jun 19, 2016 U-416
6211205 Jun 19, 2016 U-410
6271243 Jun 19, 2016 U-411
6303640 Aug 09, 2016 U-425
6329404 Jun 19, 2016 U-753
PIOGLITAZONE HYDROCHLORIDE - ACTOS
N 021073 002 5965584 Jun 19, 2016 U-753
6150383 Jun 19, 2016 U-418
6150384 Jun 19, 2016 U-419
6166042 Jun 19, 2016 U-414
6166043 Jun 19, 2016 U-415
6172090 Jun 19, 2016 U-416
6211205 Jun 19, 2016 U-410
6271243 Jun 19, 2016 U-411
6303640 Aug 09, 2016 U-425
6329404 Jun 19, 2016 U-753
PIOGLITAZONE HYDROCHLORIDE - ACTOS
N 021073 003 5965584 Jun 19, 2016 U-753
6150383 Jun 19, 2016 U-418
6150384 Jun 19, 2016 U-419
6166042 Jun 19, 2016 U-414
6166043 Jun 19, 2016 U-415
6172090 Jun 19, 2016 U-416
6211205 Jun 19, 2016 U-410
6271243 Jun 19, 2016 U-411
6303640 Aug 09, 2016 U-425
6329404 Jun 19, 2016 U-753
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N 050684 001 6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N 050684 002 6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N 050684 003 6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N 050684 004 6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER
N 050750 001 6207661 Feb 22, 2019 DP
6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER
N 050750 002 6207661 Feb 22, 2019 DP
6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER
N 050750 003 6207661 Feb 22, 2019 DP
6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 165 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PITAVASTATIN CALCIUM - LIVALO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 022363 001 5753675
5854259
5856336
6465477
7022713
8557993
May 19, 2015
Dec 29, 2015
Dec 25, 2020
Dec 20, 2016
Feb 19, 2024
Feb 02, 2024
DS DP U-998
DP
DS U-998
DP
U-998
DP
NCE Aug 03, 2014
PITAVASTATIN CALCIUM - LIVALO
N 022363 002 5753675
5854259
5856336
6465477
7022713
8557993
May 19, 2015
Dec 29, 2015
Dec 25, 2020
Dec 20, 2016
Feb 19, 2024
Feb 02, 2024
DS DP U-998
DP
DS U-998
DP
U-998
DP
NCE Aug 03, 2014
PITAVASTATIN CALCIUM - LIVALO
N 022363 003 5753675
5854259
5856336
6465477
7022713
8557993
May 19, 2015
Dec 29, 2015
Dec 25, 2020
Dec 20, 2016
Feb 19, 2024
Feb 02, 2024
DS DP U-998
DP
DS U-998
DP
U-998
DS DP
NCE Aug 03, 2014
PLERIXAFOR - MOZOBIL
N 022311 001 6987102
7897590
RE42152
Jul 22, 2023
Jul 22, 2023
Dec 10, 2018
U-936
U-936
DP
NCE
ODE
Dec 15, 2013
Dec 15, 2015
POLIDOCANOL - ASCLERA
N 021201 001 NCE Mar 30, 2015
POLIDOCANOL - ASCLERA
N 021201 002 NCE Mar 30, 2015
POLIDOCANOL - VARITHENA
N 205098 001 6572873
6846412
6942165
7025290
7357336
7604185
7731986
7814943
7842282
7842283
8122917
8323677
RE38919
RE40640
May 26, 2020
Jul 19, 2022
May 26, 2020
May 26, 2020
May 26, 2020
May 26, 2020
Nov 17, 2024
Nov 19, 2027
May 26, 2020
May 26, 2020
Sep 09, 2024
May 26, 2020
Oct 14, 2014
Oct 14, 2014
U-1461
DP
DP
DP U-1461
U-1461
DS DP U-1462
DS DP U-1463
DP U-1461
U-1461
DP
DP
DS
DS DP
DS DP U-1462
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 166 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
POMALIDOMIDE - POMALYST
N 204026 001 5635517 Jul 24, 2016 U-1359 NCE Feb 08, 2018
6045501 Aug 28, 2018 U-1361 ODE Feb 08, 2020
6315720 Oct 23, 2020 U-1361
6316471 Aug 10, 2016 DP U-1360
6476052 Jul 24, 2016 DP U-1360
6561976 Aug 28, 2018 U-1361
6561977 Oct 23, 2020 U-1361
6755784 Oct 23, 2020 U-1361
6908432 Aug 28, 2018 U-1361
8158653 Aug 10, 2016 DP
8198262 Oct 19, 2024 U-1360
8204763 Aug 28, 2018 U-1361
8315886 Oct 23, 2020 U-1361
8589188 Aug 28, 2018 U-1361
POMALIDOMIDE - POMALYST
N 204026 002 5635517 Jul 24, 2016 U-1359 NCE Feb 08, 2018
6045501 Aug 28, 2018 U-1361 ODE Feb 08, 2020
6315720 Oct 23, 2020 U-1361
6316471 Aug 10, 2016 DP U-1360
6476052 Jul 24, 2016 DP U-1360
6561976 Aug 28, 2018 U-1361
6561977 Oct 23, 2020 U-1361
6755784 Oct 23, 2020 U-1361
6908432 Aug 28, 2018 U-1361
8158653 Aug 10, 2016 DP
8198262 Oct 19, 2024 U-1360
8204763 Aug 28, 2018 U-1361
8315886 Oct 23, 2020 U-1361
8589188 Aug 28, 2018 U-1361
POMALIDOMIDE - POMALYST
N 204026 003 5635517 Jul 24, 2016 U-1359 NCE Feb 08, 2018
6045501 Aug 28, 2018 U-1361 ODE Feb 08, 2020
6315720 Oct 23, 2020 U-1361
6316471 Aug 10, 2016 DP U-1360
6476052 Jul 24, 2016 DP U-1360
6561976 Aug 28, 2018 U-1361
6561977 Oct 23, 2020 U-1361
6755784 Oct 23, 2020 U-1361
6908432 Aug 28, 2018 U-1361
8158653 Aug 10, 2016 DP
8198262 Oct 19, 2024 U-1360
8204763 Aug 28, 2018 U-1361
8315886 Oct 23, 2020 U-1361
8589188 Aug 28, 2018 U-1361
POMALIDOMIDE - POMALYST
N 204026 004 5635517 Jul 24, 2016 U-1359 NCE Feb 08, 2018
6045501 Aug 28, 2018 U-1361 ODE Feb 08, 2020
6315720 Oct 23, 2020 U-1361
6316471 Aug 10, 2016 DP U-1360
6476052 Jul 24, 2016 DP U-1360
6561976 Aug 28, 2018 U-1361
6561977 Oct 23, 2020 U-1361
6755784 Oct 23, 2020 U-1361
6908432 Aug 28, 2018 U-1361
8158653 Aug 10, 2016 DP
8198262 Oct 19, 2024 U-1360
8204763 Aug 28, 2018 U-1361
8315886 Oct 23, 2020 U-1361
8589188 Aug 28, 2018 U-1361
PONATINIB HYDROCHLORIDE - ICLUSIG
N 203469 001 8114874 Dec 22, 2026 DS DP NCE Dec 14, 2017
ODE Dec 14, 2019
PONATINIB HYDROCHLORIDE - ICLUSIG
N 203469 002 8114874 Dec 22, 2026 DS DP NCE Dec 14, 2017
ODE Dec 14, 2019
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 167 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
POSACONAZOLE - NOXAFIL
N 022003 001 5661151
5703079
6958337
8263600
Jul 19, 2019
Aug 26, 2014
Oct 05, 2018
Apr 01, 2022
DS DP U-760
DS DP U-760
DS DP U-760
DP
POSACONAZOLE - NOXAFIL
N 205053 001 5661151
5703079
Jul 19, 2019
Aug 26, 2014
DS DP U-1454
DS DP U-1454
PRALATREXATE - FOLOTYN
N 022468 001 6028071
7622470
8299078
Jul 16, 2022
May 31, 2025
May 31, 2025
DS DP U-1004
U-1015
U-1004
NCE
ODE
Sep 24, 2014
Sep 24, 2016
PRALATREXATE - FOLOTYN
N 022468 002 6028071
7622470
8299078
Jul 16, 2022
May 31, 2025
May 31, 2025
DS DP U-1004
U-1015
U-1004
NCE
ODE
Sep 24, 2014
Sep 24, 2016
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 001 6001861
6194445
Jan 16, 2018
Jan 16, 2018
U-784
U-784
M-104 May 13, 2014
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 002 6001861
6194445
Jan 16, 2018
Jan 16, 2018
U-784
U-784
M-104 May 13, 2014
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 003 6001861
6194445
Jan 16, 2018
Jan 16, 2018
U-784
U-784
M-104 May 13, 2014
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 005 6001861
6194445
Jan 16, 2018
Jan 16, 2018
U-784
U-784
M-104 May 13, 2014
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 006 6001861
6194445
Jan 16, 2018
Jan 16, 2018
U-784
U-784
M-104 May 13, 2014
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 007 6001861
6194445
Jan 16, 2018
Jan 16, 2018
U-784
U-784
M-104 May 13, 2014
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 001 7695734 Apr 26, 2028 DP
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 002 7695734 Apr 26, 2028 DP
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 003 7695734 Apr 26, 2028 DP
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 004 7695734 Apr 26, 2028 DP
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 005 7695734 Apr 26, 2028 DP
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 006 7695734 Apr 26, 2028 DP
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 007 7695734 Apr 26, 2028 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 168 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PRAMLINTIDE ACETATE - SYMLIN
N 021332 001 5686411
5814600
6114304
6608029
PRAMLINTIDE ACETATE - SYMLIN
Mar 16, 2019
Sep 29, 2015
Sep 05, 2017
Sep 07, 2013
DS DP U-638
U-639
U-640
U-641
N 021332 002 5686411
5814600
5814600
5814600
6114304
6114304
6608029
6608029
6608029
PRAMLINTIDE ACETATE - SYMLIN
Mar 16, 2019
Sep 29, 2015
Sep 29, 2015
Sep 29, 2015
Sep 05, 2017
Sep 05, 2017
Sep 07, 2013
Sep 07, 2013
Sep 07, 2013
DS DP U-638
U-637
U-638
U-639
U-637
U-640
U-637
U-640
U-641
N 021332 003 5686411
5814600
5814600
5814600
6114304
6114304
6608029
6608029
6608029
Mar 16, 2019
Sep 29, 2015
Sep 29, 2015
Sep 29, 2015
Sep 05, 2017
Sep 05, 2017
Sep 07, 2013
Sep 07, 2013
Sep 07, 2013
DS DP U-638
U-637
U-638
U-639
U-637
U-640
U-637
U-640
U-641
PRASUGREL HYDROCHLORIDE - EFFIENT
N 022307 001 5288726
8404703
8569325
Apr 14, 2017
Nov 12, 2022
Nov 12, 2022
DS DP U-991
U-1381
NCE Jul 10, 2014
PRASUGREL HYDROCHLORIDE - EFFIENT
N 022307 002 5288726
8404703
8569325
Apr 14, 2017
Nov 12, 2022
Nov 12, 2022
DS DP U-991
U-1381
NCE Jul 10, 2014
PRAVASTATIN SODIUM - PRAVACHOL
N 019898 002 5622985
PRAVASTATIN SODIUM - PRAVACHOL
Apr 22, 2014 U-335
N 019898 003 5622985
PRAVASTATIN SODIUM - PRAVACHOL
Apr 22, 2014 U-335
N 019898 004 5622985
PRAVASTATIN SODIUM - PRAVACHOL
Apr 22, 2014 U-335
N 019898 008 5622985 Apr 22, 2014 U-335
PREDNISOLONE ACETATE - FLO-PRED
N 022067 001 5881926
6071523
6399079
6656482
7799331
7799331
Mar 16, 2016
Jun 03, 2018
Jun 03, 2018
Jun 03, 2018
Oct 11, 2028
Oct 11, 2028
DP
DP
DP
DP
DP U-139
DP U-1068
PREDNISOLONE ACETATE - FLO-PRED
N 022067 002 5881926
6071523
6399079
6656482
7799331
7799331
Mar 16, 2016
Jun 03, 2018
Jun 03, 2018
Jun 03, 2018
Oct 11, 2028
Oct 11, 2028
DP
DP
DP
DP
DP U-139
DP U-1068
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 169 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
NO PATENT NO EXPIRATION PATENT
DATE CODES
PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT
N 021959 001 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
6740341 Nov 24, 2019 DP
PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT
N 021959 002 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
6740341 Nov 24, 2019 DP
PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT
N 021959 003 6024981
6221392
6740341
PREDNISONE - RAYOS
N 202020 001 6488960
6677326
8309124
8394407
PREDNISONE - RAYOS
N 202020 002 6488960
6677326
8309124
8394407
PREDNISONE - RAYOS
N 202020 003 8168218
8309124
8394407
Apr 09, 2018 DP
Apr 09, 2018 DP
Nov 24, 2019 DP
Mar 14, 2020 DP U-1267
Mar 14, 2020 DP U-1268
Apr 23, 2024 U-1292
Apr 23, 2024 DP U-1362
Mar 14, 2020 DP U-1267
Mar 14, 2020 DP U-1268
Apr 23, 2024
Apr 23, 2024 DP U-1362
Jan 07, 2028 DP U-1269
Apr 23, 2024 U-1292
Apr 23, 2024 DP U-1362
PATENT
DELIST
REQUESTED
Y
Y
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
Y
Y
Y
Y
M-128 Jul 26, 2015
M-128 Jul 26, 2015
M-128 Jul 26, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 170 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PREGABALIN - LYRICA
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021446 001 5563175
6001876
6001876
6197819
RE41920
PREGABALIN - LYRICA
Oct 08, 2013
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
U-661
U-55
U-819
DS DP
U-1250
Y
Y
I-651 Jun 20, 2015
N 021446 002 5563175
6001876
6001876
6197819
RE41920
PREGABALIN - LYRICA
Oct 08, 2013
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
U-661
U-55
U-819
DS DP
U-1250
Y
Y
I-651 Jun 20, 2015
N 021446 003 5563175
6001876
6001876
6197819
RE41920
PREGABALIN - LYRICA
Oct 08, 2013
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
U-661
U-55
U-819
DS DP
U-1250
Y
Y
I-651 Jun 20, 2015
N 021446 004 5563175
6001876
6001876
6197819
RE41920
PREGABALIN - LYRICA
Oct 08, 2013
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
U-661
U-55
U-819
DS DP
U-1250
Y
Y
I-651 Jun 20, 2015
N 021446 005 5563175
6001876
6001876
6197819
RE41920
PREGABALIN - LYRICA
Oct 08, 2013
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
U-661
U-55
U-819
DS DP
U-1250
Y
Y
I-651 Jun 20, 2015
N 021446 006 5563175
6001876
6001876
6197819
RE41920
PREGABALIN - LYRICA
Oct 08, 2013
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
U-661
U-55
U-819
DS DP
U-1250
Y
Y
I-651 Jun 20, 2015
N 021446 007 5563175
6001876
6001876
6197819
RE41920
PREGABALIN - LYRICA
Oct 08, 2013
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
U-661
U-55
U-819
DS DP
U-1250
Y
Y
I-651 Jun 20, 2015
N 021446 008 5563175
6001876
6001876
6197819
RE41920
PREGABALIN - LYRICA
Oct 08, 2013
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
U-661
U-55
U-819
DS DP
U-1250
Y
Y
I-651 Jun 20, 2015
N 022488 001 5563175
6001876
6001876
6197819
RE41920
PROGESTERONE - CRINONE
Oct 08, 2013
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
Dec 30, 2018
U-661
U-55
U-819
DS DP
U-1250
Y
Y
I-651 Jun 20, 2015
N 020701 001 5543150
PROGESTERONE - CRINONE
Sep 15, 2013 U-209
N 020701 002 5543150
PROGESTERONE - ENDOMETRIN
Sep 15, 2013 U-209
N 022057 001 7300664
7320800
7393543
Nov 17, 2019
Nov 17, 2019
Nov 17, 2019
U-856
U-856
DP U-880
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 171 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PROPAFENONE HYDROCHLORIDE - RYTHMOL SR
N 021416 001 5681588 Oct 28, 2014
PROPAFENONE HYDROCHLORIDE - RYTHMOL SR
N 021416 002 5681588 Oct 28, 2014
PROPAFENONE HYDROCHLORIDE - RYTHMOL SR
N 021416 003 5681588 Oct 28, 2014
PROPOFOL - DIPRIVAN
N 019627 002 5714520 Mar 22, 2015
5731355 Mar 22, 2015 U-217
5731356 Mar 22, 2015 U-218
5908869 Mar 22, 2015 U-270
8476010 Dec 01, 2024 DS DP
8476010*PED Jun 01, 2025
PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL
N 021438 001 6500454 Oct 04, 2021 DP
PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL
N 021438 002 6500454 Oct 04, 2021 DP
QUAZEPAM - DORAL
N 018708 001 7608616 Jun 03, 2028 U-1012
QUAZEPAM - DORAL
N 018708 003 7608616 Jun 03, 2028 U-1012
QUETIAPINE FUMARATE - SEROQUEL XR
N 022047 001 5948437 May 28, 2017 DP U-601
5948437 May 28, 2017 DP U-814
5948437 May 28, 2017 DP U-839
QUETIAPINE FUMARATE - SEROQUEL XR
N 022047 002 5948437 May 28, 2017 DP U-601
5948437 May 28, 2017 DP U-814
5948437 May 28, 2017 DP U-839
QUETIAPINE FUMARATE - SEROQUEL XR
N 022047 003 5948437 May 28, 2017 DP U-601
5948437 May 28, 2017 DP U-814
5948437 May 28, 2017 DP U-839
QUETIAPINE FUMARATE - SEROQUEL XR
N 022047 004 5948437 May 28, 2017 DP U-601
5948437 May 28, 2017 DP U-814
5948437 May 28, 2017 DP U-839
QUETIAPINE FUMARATE - SEROQUEL XR
N 022047 005 5948437 May 28, 2017 DP U-601
5948437 May 28, 2017 DP U-814
5948437 May 28, 2017 DP U-839
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N 019885 001 5684016 Nov 04, 2014 U-210
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N 019885 002 5684016 Nov 04, 2014 U-210
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N 019885 003 5684016 Nov 04, 2014 U-210
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N 019885 004 5684016 Nov 04, 2014 U-210
RABEPRAZOLE SODIUM - ACIPHEX SPRINKLE
N 204736 001 5045552*PED Nov 08, 2013 NDF Mar 26, 2016
PED Sep 26, 2016
RABEPRAZOLE SODIUM - ACIPHEX SPRINKLE
N 204736 002 5045552*PED Nov 08, 2013 NDF Mar 26, 2016
PED Sep 26, 2016
RADIUM RA-223 DICHLORIDE - XOFIGO
N 203971 001 6635234 Jan 03, 2020 U-1405 NCE May 15, 2018
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 172 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RALOXIFENE HYDROCHLORIDE - EVISTA
N 020815 001 5478847
5811120
5972383
6458811
6797719
6894064
8030330
RE39050
RE39050
Mar 02, 2014
Mar 02, 2014
Mar 02, 2014
Mar 10, 2017
Mar 10, 2017
Mar 10, 2017
Mar 10, 2017
Mar 02, 2014
Mar 02, 2014
U-114
U-287
DS DP U-825
DP
DP U-657
DP
U-657
U-662
Y ODE Sep 13, 2014
RALTEGRAVIR POTASSIUM - ISENTRESS
N 022145 001 7169780
7217713
7435734
7435734
7754731
Oct 03, 2023
Oct 21, 2022
Oct 21, 2022
Oct 21, 2022
Mar 11, 2029
DS DP
U-257
U-257
U-900
DS DP U-257
M-114
NPP
Mar 28, 2015
Dec 21, 2014
RALTEGRAVIR POTASSIUM - ISENTRESS
N 203045 001 7169780
7217713
7435734
7754731
Oct 03, 2023
Oct 21, 2022
Oct 21, 2022
Mar 11, 2029
DS DP
U-257
U-257
DS DP U-257
M-114
NDF
Mar 28, 2015
Dec 21, 2014
RALTEGRAVIR POTASSIUM - ISENTRESS
N 203045 002 7169780
7217713
7435734
7754731
Oct 03, 2023
Oct 21, 2022
Oct 21, 2022
Mar 11, 2029
DS DP
U-257
U-257
DS DP U-257
M-114
NDF
Mar 28, 2015
Dec 21, 2014
RALTEGRAVIR POTASSIUM - ISENTRESS
N 205786 001 NDF Dec 20, 2016
RAMELTEON - ROZEREM
N 021782 001 6034239 Jul 22, 2019 DS DP U-674
RAMIPRIL - ALTACE
N 019901 001 7368469
RAMIPRIL - ALTACE
Aug 30, 2020 U-871
N 019901 002 7368469
RAMIPRIL - ALTACE
Aug 30, 2020 U-871
N 019901 003 7368469
RAMIPRIL - ALTACE
Aug 30, 2020 U-871
N 019901 004 7368469
RAMIPRIL - ALTACE
Aug 30, 2020 U-871
N 022021 001 7368469
RAMIPRIL - ALTACE
Aug 30, 2020 U-871
N 022021 002 7368469
RAMIPRIL - ALTACE
Aug 30, 2020 U-871
N 022021 003 7368469
RAMIPRIL - ALTACE
Aug 30, 2020 U-871
N 022021 004 7368469 Aug 30, 2020 U-871
RANITIDINE BISMUTH CITRATE - TRITEC
N 020559 001 5601848
5629297
Feb 11, 2014
May 13, 2014
U-202
U-186
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 173 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RANOLAZINE - RANEXA
N 021526 001 6303607 May 27, 2019 U-705
6369062 May 27, 2019 DP Y
6479496 May 27, 2019 U-705
6503911 May 27, 2019 DP
6525057 May 27, 2019 U-705
6562826 May 27, 2019 U-705
6617328 May 27, 2019 DP
6620814 May 27, 2019 U-705
6852724 May 27, 2019 U-705
6864258 May 27, 2019 U-705
RANOLAZINE - RANEXA
N 021526 002 6303607 May 27, 2019 U-705
6369062 May 27, 2019 DP
6479496 May 27, 2019 U-705
6503911 May 27, 2019 DP
6525057 May 27, 2019 U-705
6562826 May 27, 2019 U-705
6617328 May 27, 2019 DP
6620814 May 27, 2019 U-705
6852724 May 27, 2019 U-705
6864258 May 27, 2019 U-705
RASAGILINE MESYLATE - AZILECT
N 021641 001 5453446 Feb 07, 2017 U-219
5532415 Jul 02, 2013 DS
6126968 Sep 18, 2016 DP
7572834 Dec 05, 2026 DP
7815942 Aug 27, 2027 DS DP U-219
RASAGILINE MESYLATE - AZILECT
N 021641 002 5453446 Feb 07, 2017 U-219
5532415 Jul 02, 2013 DS
6126968 Sep 18, 2016 DP
7572834 Dec 05, 2026 DP
7815942 Aug 27, 2027 DS DP U-219
REGADENOSON - LEXISCAN
N 022161 001 6403567 Apr 10, 2022 DS DP U-869
6642210 Jun 22, 2019 DS DP U-869
7144872 Jun 22, 2019 DS DP U-116
7144872 Jun 22, 2019 DS DP U-869
7144872 Jun 22, 2019 DS DP U-870
7183264 Jun 22, 2019 DP U-116
7183264 Jun 22, 2019 DP U-869
7183264 Jun 22, 2019 DP U-870
7582617 Jun 22, 2019 U-1003
7655636 Jun 22, 2019 U-869
7655637 Jun 22, 2019 DS DP U-869
7683037 Jun 22, 2019 U-1042
8106029 Jun 22, 2019 U-1042
8106183 Feb 02, 2027 DS
8133879 Jun 22, 2019 DP
8183226 Jun 22, 2019 U-116
8470801 Jun 22, 2019 U-116
8536150 Jun 22, 2019 U-116
REGORAFENIB - STIVARGA
N 203085 001 7351834 Jan 12, 2020 DS I-667 Feb 25, 2016
NCE Sep 27, 2017
ODE Feb 25, 2020
REMIFENTANIL HYDROCHLORIDE - ULTIVA
N 020630 001 5866591 Sep 10, 2017 DP
REMIFENTANIL HYDROCHLORIDE - ULTIVA
N 020630 002 5866591 Sep 10, 2017 DP
REMIFENTANIL HYDROCHLORIDE - ULTIVA
N 020630 003 5866591 Sep 10, 2017 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 174 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PATENT
EXPIRATION PATENT
PATENT
DELIST EXCLUSIVITY
EXCLUSIVITY
EXPIRATION
REPAGLINIDE - REPAGLINIDE
DATE CODES REQUESTED CODE(S) DATE
A 077571 002 PC Jan 20, 2014
REPAGLINIDE - REPAGLINIDE
A 077571 003 PC Jan 20, 2014
RETAPAMULIN - ALTABAX
N 022055 001 7875630
RE39128
RE43390
Feb 14, 2027
Apr 12, 2021
Apr 12, 2021
DS
DS DP U-805
DS DP U-805
RIBAVIRIN - VIRAZOLE
N 018859 001 6150337 Nov 21, 2017 U-400
RIBAVIRIN - REBETOL
N 020903 001 6172046
6172046
6177074
6177074
6461605
6461605
6472373
6472373
6524570
6524570
Sep 21, 2017
Sep 21, 2017
Nov 01, 2016
Nov 01, 2016
Nov 01, 2016
Nov 01, 2016
Sep 21, 2017
Sep 21, 2017
Nov 01, 2016
Nov 01, 2016
U-377
U-1014
U-454
U-1013
U-478
U-1013
U-479
U-1014
U-499
U-1013
RIBAVIRIN - REBETOL
N 020903 002 6172046
6172046
6177074
6177074
6461605
6461605
6472373
6472373
6524570
6524570
Sep 21, 2017
Sep 21, 2017
Nov 01, 2016
Nov 01, 2016
Nov 01, 2016
Nov 01, 2016
Sep 21, 2017
Sep 21, 2017
Nov 01, 2016
Nov 01, 2016
U-377
U-1014
U-454
U-1013
U-478
U-1013
U-479
U-1014
U-499
U-1013
RIBAVIRIN - COPEGUS
N 021511 001 NPP Aug 09, 2014
RIBAVIRIN - REBETOL
N 021546 001 6172046
6172046
6177074
6461605
6461605
6472373
6524570
6790837
Sep 21, 2017
Sep 21, 2017
Nov 01, 2016
Nov 01, 2016
Nov 01, 2016
Sep 21, 2017
Nov 01, 2016
Apr 05, 2023
U-521
U-1014
U-1013
U-521
U-1013
U-521
U-1013
DP
RIFAXIMIN - XIFAXAN
N 021361 001 7045620
7612199
7902206
7906542
7928115
8158644
8158781
8193196
8518949
Jun 19, 2024
Jun 19, 2024
Jun 19, 2024
Jun 01, 2025
Jul 24, 2029
Jun 19, 2024
Jun 19, 2024
Sep 02, 2027
Mar 27, 2026
DS DP
DS DP
DS DP
DS DP
U-1121
DP
DS
DS DP
DP
RIFAXIMIN - XIFAXAN
N 022554 001 7045620
7612199
7902206
7906542
8158644
8158781
8193196
8518949
Jun 19, 2024
Jun 19, 2024
Jun 19, 2024
Jun 01, 2025
Jun 19, 2024
Jun 19, 2024
Sep 02, 2027
Mar 27, 2026
DS
DS DP
DS DP
DS DP
DP
DS
DS DP
DP
ODE Mar 24, 2017
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 175 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RILPIVIRINE HYDROCHLORIDE - EDURANT
N 202022 001 6838464
7067522
7125879
7125879
7638522
8080551
8101629
Feb 26, 2021
Dec 20, 2019
Apr 14, 2023
Apr 14, 2023
Apr 14, 2023
Apr 11, 2023
Aug 09, 2022
DS DP
DS DP
DS DP U-1153
DS DP U-1307
DP
DS DP
DP
NCE May 20, 2016
RIOCIGUAT - ADEMPAS
N 204819 001 6743798
7173037
Jul 16, 2019
Apr 25, 2023
DS DP
DS DP
NCE
ODE
ODE
Oct 08, 2018
Oct 08, 2020
Oct 08, 2020
RIOCIGUAT - ADEMPAS
N 204819 002 6743798
7173037
Jul 16, 2019
Apr 25, 2023
DS DP
DS DP
NCE
ODE
ODE
Oct 08, 2018
Oct 08, 2020
Oct 08, 2020
RIOCIGUAT - ADEMPAS
N 204819 003 6743798
7173037
Jul 16, 2019
Apr 25, 2023
DS DP
DS DP
NCE
ODE
ODE
Oct 08, 2018
Oct 08, 2020
Oct 08, 2020
RIOCIGUAT - ADEMPAS
N 204819 004 6743798
7173037
Jul 16, 2019
Apr 25, 2023
DS DP
DS DP
NCE
ODE
ODE
Oct 08, 2018
Oct 08, 2020
Oct 08, 2020
RIOCIGUAT - ADEMPAS
N 204819 005 6743798
7173037
Jul 16, 2019
Apr 25, 2023
DS DP
DS DP
NCE
ODE
ODE
Oct 08, 2018
Oct 08, 2020
Oct 08, 2020
RISEDRONATE SODIUM - ACTONEL
N 020835 001 5583122
6165513
Dec 10, 2013
Jun 10, 2018
U-222
RISEDRONATE SODIUM - ACTONEL
N 020835 002 5583122
6165513
Dec 10, 2013
Jun 10, 2018
U-222
RISEDRONATE SODIUM - ACTONEL
N 020835 003 5583122
5583122
5994329
6015801
6165513
6432932
6465443
RISEDRONATE SODIUM - ACTONEL
Dec 10, 2013
Dec 10, 2013
Jul 17, 2018
Jul 17, 2018
Jun 10, 2018
Jul 17, 2018
Aug 14, 2018
DS DP U-222
DS DP U-756
U-353
U-353
DP
U-595
DP
N 020835 004 5583122
6165513
Dec 10, 2013
Jun 10, 2018
DS DP U-353
DP
RISEDRONATE SODIUM - ACTONEL
N 020835 005 5583122
6165513
7192938
7718634
Dec 10, 2013
Jun 10, 2018
May 06, 2023
May 06, 2023
DS DP U-353
DP
U-353
U-662
RISEDRONATE SODIUM - ATELVIA
N 022560 001 5583122
5622721
7645459
7645460
8246989
Dec 10, 2013
Apr 21, 2014
Jan 09, 2028
Jan 09, 2028
Jan 16, 2026
DS DP U-662
DP U-662
DP U-662
DP U-662
DP
NDF Oct 08, 2013
RISPERIDONE - RISPERDAL
N 020588 001 5453425
RE39181
Jul 11, 2014
Jul 11, 2014
DP
DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 176 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
RISPERIDONE - RISPERDAL CONSTA
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021346 001 5688801
5688801
5792477
5916598
5965168
6110921
6194006
6368632
6379703
6403114
6596316
6667061
7547452
RISPERIDONE - RISPERDAL CONSTA
Nov 18, 2014
Nov 18, 2014
May 02, 2017
May 02, 2017
Nov 19, 2013
Nov 19, 2013
Dec 30, 2018
Nov 19, 2013
Dec 30, 2018
May 02, 2017
Dec 30, 2018
May 25, 2020
Nov 19, 2013
U-543
U-972
DP
DP
DP
U-543
DP
U-543
DP
DP
DP
DP
DP
N 021346 002 5688801
5688801
5792477
5916598
5965168
6110921
6194006
6368632
6379703
6403114
6596316
6667061
7547452
RISPERIDONE - RISPERDAL CONSTA
Nov 18, 2014
Nov 18, 2014
May 02, 2017
May 02, 2017
Nov 19, 2013
Nov 19, 2013
Dec 30, 2018
Nov 19, 2013
Dec 30, 2018
May 02, 2017
Dec 30, 2018
May 25, 2020
Nov 19, 2013
U-543
U-972
DP
DP
DP
U-543
DP
U-543
DP
DP
DP
DP
DP
N 021346 003 5688801
5688801
5792477
5916598
5965168
6110921
6194006
6368632
6379703
6403114
6596316
6667061
7547452
RISPERIDONE - RISPERDAL CONSTA
Nov 18, 2014
Nov 18, 2014
May 02, 2017
May 02, 2017
Nov 19, 2013
Nov 19, 2013
Dec 30, 2018
Nov 19, 2013
Dec 30, 2018
May 02, 2017
Dec 30, 2018
May 25, 2020
Nov 19, 2013
U-543
U-972
DP
DP
DP
U-543
DP
U-543
DP
DP
DP
DP
DP
N 021346 004 5688801
5688801
5792477
5916598
5965168
6110921
6194006
6368632
6379703
6403114
6596316
7547452
Nov 18, 2014
Nov 18, 2014
May 02, 2017
May 02, 2017
Nov 19, 2013
Nov 19, 2013
Dec 30, 2018
Nov 19, 2013
Dec 30, 2018
May 02, 2017
Dec 30, 2018
Nov 19, 2013
U-543
U-972
DP
DP
DP
U-543
DP
U-543
DP
DP
DP
DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 177 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PATENT
EXPIRATION PATENT
PATENT
DELIST EXCLUSIVITY
EXCLUSIVITY
EXPIRATION
RISPERIDONE - RISPERDAL
DATE CODES REQUESTED CODE(S) DATE
N 021444 001 5648093
6224905
Jul 15, 2014
Jun 10, 2017
DP
DP
RISPERIDONE - RISPERDAL
N 021444 002 5648093
6224905
Jul 15, 2014
Jun 10, 2017
DP
DP
RISPERIDONE - RISPERDAL
N 021444 003 5648093
6224905
Jul 15, 2014
Jun 10, 2017
DP
DP
RISPERIDONE - RISPERDAL
N 021444 004 5648093
6224905
Jul 15, 2014
Jun 10, 2017
DP
DP
RISPERIDONE - RISPERDAL
N 021444 005 5648093
6224905
Jul 15, 2014
Jun 10, 2017
DP
DP
RITONAVIR - NORVIR
N 020659 001 5484801
5541206
5635523
5648497
5674882
5948436
6037157
6703403
Jan 28, 2014
Jul 30, 2013
Jul 30, 2013
Jul 15, 2014
Jul 30, 2013
Sep 13, 2013
Jun 26, 2016
Jun 26, 2016
U-140
U-190
U-688
DP
U-564
RITONAVIR - NORVIR
N 020680 001 5541206
5635523
5648497
5948436
Jul 30, 2013
Jun 03, 2014
Jul 15, 2014
Sep 13, 2013
U-140
U-190
RITONAVIR - NORVIR
N 020945 001 5541206
5635523
5648497
5674882
5948436
6037157
6232333
6703403
7141593
7432294
RITONAVIR - NORVIR
Jul 30, 2013
Jul 30, 2013
Jul 15, 2014
Jul 30, 2013
Sep 13, 2013
Jun 26, 2016
Nov 07, 2017
Jun 26, 2016
May 22, 2020
May 22, 2020
U-348
U-347
U-895
DP
U-895
U-564
DP
DP
N 022417 001 5541206
5635523
5648497
5674882
6037157
6703403
7148359
7364752
8268349
8399015
8399015*PED
8470347
8470347*PED
Jul 30, 2013
Jul 30, 2013
Jul 15, 2014
Jul 30, 2013
Jun 26, 2016
Jun 26, 2016
Jul 19, 2019
Nov 10, 2020
Aug 25, 2024
Aug 25, 2024
Feb 25, 2025
Sep 17, 2026
Mar 17, 2027
DS DP U-688
U-688
DS
U-688
U-688
U-688
DP
DP U-688
DP
DP
DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 178 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RIVAROXABAN - XARELTO
N 022406 001 7157456 Feb 08, 2021 DS DP U-1301 I-660 Nov 02, 2015
7157456 Feb 08, 2021 DS DP U-1302 I-661 Nov 02, 2015
7585860 Dec 11, 2020 DS U-1303 I-662 Nov 02, 2015
7592339 Dec 11, 2020 U-1167 NCE Jul 01, 2016
7592339 Dec 11, 2020 U-1200
7592339 Dec 11, 2020 U-1301
7592339 Dec 11, 2020 U-1302
7592339 Dec 11, 2020 U-1303
RIVAROXABAN - XARELTO
N 022406 002 7157456 Feb 08, 2021 DS DP U-1301 I-643 Nov 04, 2014
7157456 Feb 08, 2021 DS DP U-1302 I-660 Nov 02, 2015
7585860 Dec 11, 2020 DS U-1303 I-661 Nov 02, 2015
7592339 Dec 11, 2020 U-1167 I-662 Nov 02, 2015
7592339 Dec 11, 2020 U-1200 NCE Jul 01, 2016
7592339 Dec 11, 2020 U-1301
7592339 Dec 11, 2020 U-1302
7592339 Dec 11, 2020 U-1303
RIVAROXABAN - XARELTO
N 022406 003 7157456 Feb 08, 2021 DS DP U-1301 I-643 Nov 04, 2014
7157456 Feb 08, 2021 DS DP U-1302 I-660 Nov 02, 2015
7585860 Dec 11, 2020 DS U-1303 I-661 Nov 02, 2015
7592339 Dec 11, 2020 U-1167 I-662 Nov 02, 2015
7592339 Dec 11, 2020 U-1200 NCE Jul 01, 2016
7592339 Dec 11, 2020 U-1301
7592339 Dec 11, 2020 U-1302
7592339 Dec 11, 2020 U-1303
RIVASTIGMINE - EXELON
N 022083 001 5602176 Feb 11, 2014 DS DP U-322
6316023 Jan 08, 2019 DP
6335031 Jan 08, 2019 DP
RIVASTIGMINE - EXELON
N 022083 002 5602176 Feb 11, 2014 DS DP U-322
6316023 Jan 08, 2019 DP
6335031 Jan 08, 2019 DP
RIVASTIGMINE - EXELON
N 022083 005 5602176 Feb 11, 2014 DS DP U-322 NPP Jun 27, 2016
6316023 Jan 08, 2019 DP NS Aug 31, 2015
6335031 Jan 08, 2019 DP
RIVASTIGMINE TARTRATE - EXELON
N 020823 003 5602176 Feb 11, 2014 U-322
RIVASTIGMINE TARTRATE - EXELON
N 020823 004 5602176 Feb 11, 2014 U-322
RIVASTIGMINE TARTRATE - EXELON
N 020823 005 5602176 Feb 11, 2014 U-322
RIVASTIGMINE TARTRATE - EXELON
N 020823 006 5602176 Feb 11, 2014 U-322
RIVASTIGMINE TARTRATE - EXELON
N 021025 001 5602176 Feb 11, 2014 U-322
RIZATRIPTAN BENZOATE - MAXALT
N 020864 001 NPP Dec 16, 2014
PED Jun 16, 2015
RIZATRIPTAN BENZOATE - MAXALT
N 020864 002 NPP Dec 16, 2014
PED Jun 16, 2015
RIZATRIPTAN BENZOATE - MAXALT-MLT
N 020865 001 5457895 Oct 01, 2013 DP NPP Dec 16, 2014
PED Jun 16, 2015
RIZATRIPTAN BENZOATE - MAXALT-MLT
N 020865 002 5457895 Oct 01, 2013 DP NPP Dec 16, 2014
PED Jun 16, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 179 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ROFECOXIB - VIOXX
N 021042 001 5691374
6063811
ROFECOXIB - VIOXX
May 18, 2015
May 06, 2017 U-602
N 021042 002 5691374
6063811
ROFECOXIB - VIOXX
May 18, 2015
May 06, 2017 U-602
N 021042 003 5691374
6063811
ROFECOXIB - VIOXX
May 18, 2015
May 06, 2017 U-602
N 021052 001 5691374
6063811
ROFECOXIB - VIOXX
May 18, 2015
May 06, 2017 U-266
N 021052 002 5691374
6063811
May 18, 2015
May 06, 2017 U-266
ROFLUMILAST - DALIRESP
N 022522 001 5712298
8431154
8536206
8604064
Jan 27, 2015
Feb 19, 2023
Mar 08, 2024
Mar 08, 2024
DS DP U-1115
DP
U-1115
U-1115
NCE Feb 28, 2016
ROMIDEPSIN - ISTODAX
N 022393 001 4977138
7608280
7611724
Aug 22, 2013
Aug 22, 2021
Aug 22, 2021
DS DP
DS
DS
NCE
ODE
ODE
Nov 05, 2014
Nov 05, 2016
Jun 16, 2018
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 001 7927624 Dec 02, 2021
8303986 Apr 12, 2021
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 002 7927624 Dec 02, 2021
8303986 Apr 12, 2021
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 003 7927624 Dec 02, 2021
8303986 Apr 12, 2021
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 004 7927624 Dec 02, 2021
8303986 Apr 12, 2021
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 005 7927624 Dec 02, 2021
8303986 Apr 12, 2021
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 006 7927624 Dec 02, 2021
8303986 Apr 12, 2021
DP U-20
DP
DP U-20
DP
DP U-20
DP
DP U-20
DP
DP U-20
DP
DP U-20
DP
ROPIVACAINE HYDROCHLORIDE - NAROPIN
N 020533 001 5670524 Sep 23, 2014
5834489 May 26, 2014
ROPIVACAINE HYDROCHLORIDE - NAROPIN
DS DP U-833
DS DP U-838
N 020533 003 5670524 Sep 23, 2014
5834489 May 26, 2014
ROPIVACAINE HYDROCHLORIDE - NAROPIN
DS DP U-833
DS DP U-838
N 020533 004 5670524 Sep 23, 2014
5834489 May 26, 2014
ROPIVACAINE HYDROCHLORIDE - NAROPIN
DS DP U-833
DS DP U-838
N 020533 005 5670524
5834489
Sep 23, 2014
May 26, 2014
DS DP U-833
DS DP U-838
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 180 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
ROSIGLITAZONE MALEATE - AVANDIA
N 021071 002 5741803
5741803
6288095
7358366
ROSIGLITAZONE MALEATE - AVANDIA
N 021071 003 5741803
5741803
6288095
7358366
ROSIGLITAZONE MALEATE - AVANDIA
N 021071 004 5741803
5741803
6288095
7358366
ROSUVASTATIN CALCIUM - CRESTOR
N 021366 002 6316460
6858618
7030152
7964614
RE37314
ROSUVASTATIN CALCIUM - CRESTOR
N 021366 003 6316460
6858618
7030152
7964614
RE37314
ROSUVASTATIN CALCIUM - CRESTOR
N 021366 004 6316460
6858618
7030152
7964614
RE37314
ROSUVASTATIN CALCIUM - CRESTOR
N 021366 005 6316460
6858618
7030152
7964614
RE37314
PATENT
EXPIRATION
DATE
Apr 21, 2015
Apr 21, 2015
Feb 11, 2017
Apr 19, 2020
Apr 21, 2015
Apr 21, 2015
Feb 11, 2017
Apr 19, 2020
Apr 21, 2015
Apr 21, 2015
Feb 11, 2017
Apr 19, 2020
Aug 04, 2020
Dec 17, 2021
Apr 02, 2018
Apr 02, 2018
Jan 08, 2016
Aug 04, 2020
Dec 17, 2021
Apr 02, 2018
Apr 02, 2018
Jan 08, 2016
Aug 04, 2020
Dec 17, 2021
Apr 02, 2018
Apr 02, 2018
Jan 08, 2016
Aug 04, 2020
Dec 17, 2021
Apr 02, 2018
Apr 02, 2018
Jan 08, 2016
PATENT EXCLUSIVITY
PATENT DELIST EXCLUSIVITY EXPIRATION
CODES REQUESTED CODE(S) DATE
DS DP U-329 Y
DS DP U-628 Y
U-420 Y
DS
DS DP U-329 Y
DS DP U-628 Y
U-420 Y
DS
DS DP U-329 Y
DS DP U-628 Y
U-420 Y
DS
DP
U-618
U-1032
U-1032
DS
DP
U-618
U-1032
U-1032
DS
DP
U-618
U-1032
U-1032
DS
DP
U-618
U-1032
U-1032
DS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 181 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
ROTIGOTINE - NEUPRO
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021829 001 6699498
6884434
7413747
8246979
8246979
8246980
8617591
Nov 27, 2020
Mar 30, 2021
Mar 18, 2019
Sep 01, 2027
Sep 01, 2027
Nov 27, 2025
Jul 22, 2023
DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474
I-646
I-647
Apr 02, 2015
Apr 02, 2015
ROTIGOTINE - NEUPRO
N 021829 002 6699498
6884434
7413747
8246979
8246979
8246980
8617591
Nov 27, 2020
Mar 30, 2021
Mar 18, 2019
Sep 01, 2027
Sep 01, 2027
Nov 27, 2025
Jul 22, 2023
DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474
I-646
I-647
Apr 02, 2015
Apr 02, 2015
ROTIGOTINE - NEUPRO
N 021829 003 6699498
6884434
7413747
8246979
8246979
8246980
8617591
Nov 27, 2020
Mar 30, 2021
Mar 18, 2019
Sep 01, 2027
Sep 01, 2027
Nov 27, 2025
Jul 22, 2023
DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474
I-646
I-647
Apr 02, 2015
Apr 02, 2015
ROTIGOTINE - NEUPRO
N 021829 004 6699498
6884434
7413747
8246979
8246979
8246980
8617591
Nov 27, 2020
Mar 30, 2021
Mar 18, 2019
Sep 01, 2027
Sep 01, 2027
Nov 27, 2025
Jul 22, 2023
DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474
I-646
I-647
Apr 02, 2015
Apr 02, 2015
ROTIGOTINE - NEUPRO
N 021829 005 6699498
6884434
7413747
8246979
8246979
8246980
8617591
Nov 27, 2020
Mar 30, 2021
Mar 18, 2019
Sep 01, 2027
Sep 01, 2027
Nov 27, 2025
Jul 22, 2023
DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474
I-646
I-647
Apr 02, 2015
Apr 02, 2015
ROTIGOTINE - NEUPRO
N 021829 006 6699498
6884434
7413747
8246979
8246979
8246980
8617591
Nov 27, 2020
Mar 30, 2021
Mar 18, 2019
Sep 01, 2027
Sep 01, 2027
Nov 27, 2025
Jul 22, 2023
DP
DP
DP
DP U-1272
DP U-1273
DP
DP U-1474
I-646
I-647
Apr 02, 2015
Apr 02, 2015
RUFINAMIDE - BANZEL
N 021911 001 6740669
7750028
8076362
Nov 14, 2022
Oct 19, 2018
Jun 08, 2018
DS DP
U-106
DP
NCE
ODE
Nov 14, 2013
Nov 14, 2015
RUFINAMIDE - BANZEL
N 021911 002 6740669
7750028
8076362
Nov 14, 2022
Oct 19, 2018
Jun 08, 2018
DS DP
U-106
DP
NCE
ODE
Nov 14, 2013
Nov 14, 2015
RUFINAMIDE - BANZEL
N 021911 003 6740669
7750028
8076362
Nov 14, 2022
Oct 19, 2018
Jun 08, 2018
DS DP
U-106
DP
NCE
ODE
Nov 14, 2013
Nov 14, 2015
RUFINAMIDE - BANZEL
N 201367 001 6740669
7750028
Nov 14, 2022
Oct 19, 2018
DS DP
U-106
NCE
ODE
Nov 14, 2013
Nov 14, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 182 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RUXOLITINIB PHOSPHATE - JAKAFI
N 202192 001 7598257
8415362
Dec 24, 2027
Dec 24, 2027
DS DP U-1201
DS DP
NCE
ODE
Nov 16, 2016
Nov 16, 2018
RUXOLITINIB PHOSPHATE - JAKAFI
N 202192 002 7598257
8415362
Dec 24, 2027
Dec 24, 2027
DS DP U-1201
DS DP
NCE
ODE
Nov 16, 2016
Nov 16, 2018
RUXOLITINIB PHOSPHATE - JAKAFI
N 202192 003 7598257
8415362
Dec 24, 2027
Dec 24, 2027
DS DP U-1201
DS DP
NCE
ODE
Nov 16, 2016
Nov 16, 2018
RUXOLITINIB PHOSPHATE - JAKAFI
N 202192 004 7598257
8415362
Dec 24, 2027
Dec 24, 2027
DS DP U-1201
DS DP
NCE
ODE
Nov 16, 2016
Nov 16, 2018
RUXOLITINIB PHOSPHATE - JAKAFI
N 202192 005 7598257
8415362
Dec 24, 2027
Dec 24, 2027
DS DP U-1201
DS DP
NCE
ODE
Nov 16, 2016
Nov 16, 2018
SALMETEROL XINAFOATE - SEREVENT
N 020692 001 5873360 Feb 23, 2016 DP
SAPROPTERIN DIHYDROCHLORIDE - KUVAN
N 022181 001 7566462
7566714
7612073
7727987
7947681
8003126
8067416
8318745
RE43797
Nov 16, 2025
Nov 17, 2024
Nov 17, 2024
Nov 17, 2024
Nov 17, 2024
Nov 16, 2025
Nov 17, 2024
Nov 17, 2024
Nov 17, 2024
DP
U-989
U-1010
DP
U-1156
U-989
DP
U-1156
ODE Dec 13, 2014
SAQUINAVIR - FORTOVASE
N 020828 001 6008228
6352717
Jun 06, 2015
Nov 16, 2019
SAQUINAVIR MESYLATE - INVIRASE
N 020628 001
SAQUINAVIR MESYLATE - INVIRASE
N 021785 001
SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA
M-61
PED
M-61
PED
Nov 30, 2015
May 30, 2016
Nov 30, 2015
May 30, 2016
N 022350 001 7951400
RE44186
Nov 30, 2028
Jul 31, 2023
DP
DS DP U-995
M-108
NCE
Dec 16, 2014
Jul 31, 2014
SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA
N 022350 002 7951400
RE44186
Nov 30, 2028
Jul 31, 2023
DP
DS DP U-995
M-108
NCE
Dec 16, 2014
Jul 31, 2014
SELEGILINE - EMSAM
N 021336 001 7070808
7150881
7638140
SELEGILINE - EMSAM
May 10, 2018
Jun 12, 2018
May 10, 2018
DS DP
DS DP
DP
N 021336 002 7070808
7150881
7638140
SELEGILINE - EMSAM
May 10, 2018
Jun 12, 2018
May 10, 2018
DS DP
DS DP
DP
N 021336 003 7070808 May 10, 2018
7150881 Jun 12, 2018
7638140 May 10, 2018
SELEGILINE HYDROCHLORIDE - ZELAPAR
DS DP
DS DP
DP
N 021479 001 5648093
6423342
Jul 15, 2014
Mar 01, 2016
DP
DP
SERTACONAZOLE NITRATE - ERTACZO
N 021385 001 5135943 May 31, 2014 DS DP U-786
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 183 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SERTRALINE HYDROCHLORIDE - ZOLOFT
N 020990 001 6727283 Oct 11, 2019 DP U-580
7067555 Oct 11, 2019 DP
7067555*PED Apr 11, 2020
SEVELAMER CARBONATE - RENVELA
N 022127 001 5496545 Aug 11, 2013 DP U-246
5667775 Sep 16, 2014 U-246
6509013 Aug 11, 2013 DP
6858203 Aug 11, 2013 DP U-246
7014846 Aug 11, 2013 DP U-246
7459151 Aug 11, 2013 U-246
7985418 Oct 27, 2025 DP
SEVELAMER CARBONATE - RENVELA
N 022318 001 5496545 Aug 11, 2013 DP U-246
5667775 Sep 16, 2014 U-246
6509013 Aug 11, 2013 DP
6858203 Aug 11, 2013 DP U-246
7014846 Aug 11, 2013 DP U-246
7459151 Aug 11, 2013 U-246
SEVELAMER CARBONATE - RENVELA
N 022318 002 5496545 Aug 11, 2013 DP U-246
5667775 Sep 16, 2014 U-246
6509013 Aug 11, 2013 DP
6858203 Aug 11, 2013 DP U-246
7014846 Aug 11, 2013 DP U-246
7459151 Aug 11, 2013 U-246
SEVELAMER HYDROCHLORIDE - RENAGEL
N 020926 001 5496545 Aug 11, 2013 U-246
5667775 Sep 16, 2014 U-246
6509013 Aug 11, 2013
SEVELAMER HYDROCHLORIDE - RENAGEL
N 021179 001 5496545 Aug 11, 2013 U-246
5667775 Sep 16, 2014 U-246
6509013 Aug 11, 2013
6733780 Oct 18, 2020 DP
7014846 Aug 11, 2013 DP U-246
7459151 Aug 11, 2013 U-246
SEVELAMER HYDROCHLORIDE - RENAGEL
N 021179 002 5496545 Aug 11, 2013 U-246
5667775 Sep 16, 2014 U-246
6509013 Aug 11, 2013
6733780 Oct 18, 2020 DP
7014846 Aug 11, 2013 DP U-246
7459151 Aug 11, 2013 U-246
SEVOFLURANE - ULTANE
N 020478 001 5990176 Jan 27, 2017
6074668 Jan 09, 2018
6288127 Jan 27, 2017
6444859 Jan 27, 2017
SILDENAFIL CITRATE - VIAGRA
N 020895 001 6469012 Oct 22, 2019 U-155
SILDENAFIL CITRATE - VIAGRA
N 020895 002 6469012 Oct 22, 2019 U-155
SILDENAFIL CITRATE - VIAGRA
N 020895 003 6469012 Oct 22, 2019 U-155
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 184 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
PATENT
EXPIRATION PATENT
PATENT
DELIST EXCLUSIVITY
SILDENAFIL CITRATE - REVATIO
DATE CODES REQUESTED CODE(S)
N 021845 001 M-61
PED
SILDENAFIL CITRATE - REVATIO
N 022473 001 M-61
PED
SILDENAFIL CITRATE - REVATIO
N 203109 001 NDF
PED
SILODOSIN - RAPAFLO
N 022206 001 5387603 Dec 01, 2018 DS DP NCE
SILODOSIN - RAPAFLO
N 022206 002 5387603 Dec 01, 2018 DS DP NCE
SIMEPREVIR - OLYSIO
N 205123 001 7671032
8148399
8349869
May 19, 2025
Sep 05, 2029
Jul 28, 2026
DS DP
DS DP U-1467
DS DP U-1467
NCE
EXCLUSIVITY
EXPIRATION
DATE
Aug 30, 2015
Mar 01, 2016
Aug 30, 2015
Mar 01, 2016
Aug 30, 2015
Mar 01, 2016
Oct 08, 2013
Oct 08, 2013
Nov 22, 2018
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 185 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
NO PATENT NO EXPIRATION
DATE
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 001 6303661 Apr 24, 2017
6699871 Jul 26, 2022
6890898 Feb 02, 2019
6890898 Feb 02, 2019
6890898 Feb 02, 2019
7078381 Feb 02, 2019
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7326708 Apr 11, 2026
7459428 Feb 02, 2019
8168637 Jun 26, 2022
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 002 6303661 Apr 24, 2017
6699871 Jul 26, 2022
6890898 Feb 02, 2019
6890898 Feb 02, 2019
6890898 Feb 02, 2019
7078381 Feb 02, 2019
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7326708 Apr 11, 2026
7459428 Feb 02, 2019
8168637 Jun 26, 2022
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 003 6303661 Apr 24, 2017
6699871 Jul 26, 2022
6890898 Feb 02, 2019
6890898 Feb 02, 2019
6890898 Feb 02, 2019
7078381 Feb 02, 2019
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7326708 Apr 11, 2026
7459428 Feb 02, 2019
8168637 Jun 26, 2022
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 004 6303661 Apr 24, 2017
6699871 Jul 26, 2022
6890898 Feb 02, 2019
6890898 Feb 02, 2019
6890898 Feb 02, 2019
7078381 Feb 02, 2019
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7125873 Jul 26, 2022
7326708 Apr 11, 2026
7459428 Feb 02, 2019
8168637 Jun 26, 2022
PATENT EXCLUSIVITY
PATENT DELIST EXCLUSIVITY EXPIRATION
CODES REQUESTED CODE(S) DATE
U-1188
DS DP U-1188
U-1189
U-1190
U-1191
U-1188
DP U-1189
DP U-1190
DP U-1192
DP U-1193
DS DP U-1188
U-1189
DP U-1188
U-1188
DS DP U-1188
U-1189
U-1190
U-1191
U-1188
DP U-1189
DP U-1190
DP U-1192
DP U-1193
DS DP U-1188
U-1189
DP U-1188
U-1188
DS DP U-1188
U-1189
U-1190
U-1191
U-1188
DP U-1189
DP U-1190
DP U-1192
DP U-1193
DS DP U-1188
U-1189
DP U-1188
U-1188
DS DP U-1188
U-1189
U-1190
U-1191
U-1188
DP U-1189
DP U-1190
DP U-1192
DP U-1193
DS DP U-1188
U-1189
DP U-1188
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 186 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 005 6303661 Apr 24, 2017 U-1188
6699871 Jul 26, 2022 DS DP U-1188
6890898 Feb 02, 2019 U-1189
6890898 Feb 02, 2019 U-1190
6890898 Feb 02, 2019 U-1191
7078381 Feb 02, 2019 U-1188
7125873 Jul 26, 2022 DP U-1189
7125873 Jul 26, 2022 DP U-1190
7125873 Jul 26, 2022 DP U-1192
7125873 Jul 26, 2022 DP U-1193
7326708 Apr 11, 2026 DS DP U-1188
7459428 Feb 02, 2019 U-1189
8168637 Jun 26, 2022 DP U-1188
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 006 6303661 Apr 24, 2017 U-1188
6699871 Jul 26, 2022 DS DP U-1188
6890898 Feb 02, 2019 U-1189
6890898 Feb 02, 2019 U-1190
6890898 Feb 02, 2019 U-1191
7078381 Feb 02, 2019 U-1188
7125873 Jul 26, 2022 DP U-1189
7125873 Jul 26, 2022 DP U-1190
7125873 Jul 26, 2022 DP U-1192
7125873 Jul 26, 2022 DP U-1193
7326708 Apr 11, 2026 DS DP U-1188
7459428 Feb 02, 2019 U-1189
8168637 Jun 26, 2022 DP U-1188
SINCALIDE - KINEVAC
N 017697 001 6803046 Aug 16, 2022 DP
SINECATECHINS - VEREGEN
N 021902 001 5795911 Oct 31, 2020 U-172
5968973 Apr 10, 2017 U-172
7858662 Oct 02, 2026 DP U-172
SIROLIMUS - RAPAMUNE
N 021083 001 5100899 Jul 07, 2013 U-290
5536729 Sep 30, 2013 DP
SIROLIMUS - RAPAMUNE
N 021110 001 5100899 Jul 07, 2013 U-290
5989591 Mar 11, 2018 DP
SIROLIMUS - RAPAMUNE
N 021110 002 5100899 Jul 07, 2013 U-290
5989591 Mar 11, 2018 DP
SIROLIMUS - RAPAMUNE
N 021110 003 5100899 Jul 07, 2013 U-290
5989591 Mar 11, 2018 DP
SIROLIMUS - RAPAMUNE
N 021110 004 5100899 Jul 07, 2013 U-290
5989591 Mar 11, 2018 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 187 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SITAGLIPTIN PHOSPHATE - JANUVIA
N 021995 001 6303661 Apr 24, 2017 U-774
6699871 Jul 26, 2022 DS DP U-774
6890898 Feb 02, 2019 U-775
6890898 Feb 02, 2019 U-1036
6890898 Feb 02, 2019 U-1039
7078381 Feb 02, 2019 U-775
7078381 Feb 02, 2019 U-1036
7078381 Feb 02, 2019 U-1037
7078381 Feb 02, 2019 U-1038
7125873 Jul 26, 2022 U-775
7125873 Jul 26, 2022 U-1036
7125873 Jul 26, 2022 U-1037
7125873 Jul 26, 2022 U-1038
7326708 Apr 11, 2026 DS DP U-802
SITAGLIPTIN PHOSPHATE - JANUVIA
N 021995 002 6303661 Apr 24, 2017 U-774
6699871 Jul 26, 2022 DS DP U-774
6890898 Feb 02, 2019 U-775
6890898 Feb 02, 2019 U-1036
6890898 Feb 02, 2019 U-1039
7078381 Feb 02, 2019 U-775
7078381 Feb 02, 2019 U-1036
7078381 Feb 02, 2019 U-1037
7078381 Feb 02, 2019 U-1038
7125873 Jul 26, 2022 U-775
7125873 Jul 26, 2022 U-1036
7125873 Jul 26, 2022 U-1037
7125873 Jul 26, 2022 U-1038
7326708 Apr 11, 2026 DS DP U-802
SITAGLIPTIN PHOSPHATE - JANUVIA
N 021995 003 6303661 Apr 24, 2017 U-774
6699871 Jul 26, 2022 DS DP U-774
6890898 Feb 02, 2019 U-775
6890898 Feb 02, 2019 U-1036
6890898 Feb 02, 2019 U-1039
7078381 Feb 02, 2019 U-775
7078381 Feb 02, 2019 U-1036
7078381 Feb 02, 2019 U-1037
7078381 Feb 02, 2019 U-1038
7125873 Jul 26, 2022 U-775
7125873 Jul 26, 2022 U-1036
7125873 Jul 26, 2022 U-1037
7125873 Jul 26, 2022 U-1038
7326708 Apr 11, 2026 DS DP U-802
SODIUM NITRITE - SODIUM NITRITE
N 203922 001 8568793 Dec 24, 2031 DS DP ODE Jan 14, 2018
SODIUM NITRITE; SODIUM THIOSULFATE - NITHIODOTE
N 201444 001 8496973 Mar 29, 2031 DS DP U-1419 ODE Jan 14, 2018
8568793 Dec 24, 2031 DS DP
SODIUM OXYBATE - XYREM
N 021196 001 6780889 Jul 04, 2020 DP
7262219 Jul 04, 2020 DP
7668730 Jun 16, 2024 U-1110
7765106 Jun 16, 2024 U-1069
7765107 Jun 16, 2024 U-1070
7851506 Dec 22, 2019 U-1101
7851506 Dec 22, 2019 U-1102
7895059 Dec 17, 2022 U-1110
8263650 Dec 22, 2019 DP U-1101
8263650 Dec 22, 2019 DP U-1102
8324275 Dec 22, 2019 U-1101
8324275 Dec 22, 2019 U-1102
8457988 Dec 17, 2022 U-1110
8589182 Dec 17, 2022 U-1110
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 188 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - OSMOPREP
N 021892 001 7687075 Jun 22, 2028 DS DP
SODIUM THIOSULFATE - SODIUM THIOSULFATE
N 203923 001 8496973 Mar 29, 2031 DS DP U-1419 ODE Jan 14, 2018
SOFOSBUVIR - SOVALDI
N 204671 001 7964580 Mar 26, 2029 DS DP U-1470
8334270 Mar 21, 2028 DS DP U-1470
8580765 Mar 21, 2028 DS DP U-1470
SOLIFENACIN SUCCINATE - VESICARE
N 021518 001 6017927 Nov 19, 2018 DS DP
SOLIFENACIN SUCCINATE - VESICARE
N 021518 002 6017927 Nov 19, 2018 DS DP
SOMATROPIN RECOMBINANT - HUMATROPE
N 019640 001 ODE Nov 01, 2013
SOMATROPIN RECOMBINANT - HUMATROPE
N 019640 004 ODE Nov 01, 2013
SOMATROPIN RECOMBINANT - HUMATROPE
N 019640 005 ODE Nov 01, 2013
SOMATROPIN RECOMBINANT - HUMATROPE
N 019640 006 ODE Nov 01, 2013
SOMATROPIN RECOMBINANT - HUMATROPE
N 019640 007 ODE Nov 01, 2013
SOMATROPIN RECOMBINANT - SAIZEN
N 019764 002 5898030 Apr 27, 2016 DP
SOMATROPIN RECOMBINANT - SAIZEN
N 019764 003 5898030 Apr 27, 2016 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 001 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 002 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 003 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 005 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 008 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 009 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 010 5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 011 5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 012 5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 013 5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - NUTROPIN AQ
N 020522 001 5763394 Jun 09, 2015 DP
SOMATROPIN RECOMBINANT - NUTROPIN AQ PEN
N 020522 002 5763394 Jun 09, 2015 DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 189 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SOMATROPIN RECOMBINANT - SEROSTIM
N 020604 001 5898030 Apr 27, 2016
SOMATROPIN RECOMBINANT - SEROSTIM
DP
N 020604 002 5898030 Apr 27, 2016
SOMATROPIN RECOMBINANT - SEROSTIM
DP
N 020604 003 5898030 Apr 27, 2016
SOMATROPIN RECOMBINANT - SEROSTIM
DP
N 020604 004 5898030 Apr 27, 2016
SOMATROPIN RECOMBINANT - NUTROPIN DEPOT
DP
N 021075 001 5654010
5656297
Aug 05, 2014
Jul 25, 2014
SOMATROPIN RECOMBINANT - NUTROPIN DEPOT
N 021075 002 5654010
5656297
Aug 05, 2014
Jul 25, 2014
SOMATROPIN RECOMBINANT - NUTROPIN DEPOT
N 021075 003 5654010
5656297
Aug 05, 2014
Jul 25, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN
N 021148 001 5849700
5849704
Dec 15, 2015
Dec 15, 2015
U-340 ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN
N 021148 002 5849700
5849704
Dec 15, 2015
Dec 15, 2015
U-340 ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN
N 021148 003 5633352
5849700
5849704
May 27, 2014
Dec 15, 2015
Dec 15, 2015
U-340
ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N 021148 004 5849700
5849704
6004297
6235004
RE41956
Dec 15, 2015
Dec 15, 2015
Jan 28, 2019
Jan 28, 2019
Jan 21, 2021
U-340
DP U-340
DP
DP
DP
ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N 021148 005 5849700
5849704
6004297
6235004
RE41956
Dec 15, 2015
Dec 15, 2015
Jan 28, 2019
Jan 28, 2019
Jan 21, 2021
U-340
DP U-340
DP
DP
DP
ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N 021148 006 5849700
5849704
6004297
6235004
RE41956
Dec 15, 2015
Dec 15, 2015
Jan 28, 2019
Jan 28, 2019
Jan 21, 2021
U-340
DP U-340
DP
DP
DP
ODE May 31, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N 021148 007 5849700
5849704
6004297
RE41956
RE43834
Dec 15, 2015
Dec 15, 2015
Jan 28, 2019
Jan 21, 2021
Jan 28, 2019
U-340
DP U-340
DP
DP
DP
ODE May 31, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 190 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO
N 021148 008 5849700 Dec 15, 2015
5849704 Dec 15, 2015
6899699 Jan 02, 2022
7686786 Aug 03, 2026
SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO
U-1041
DP U-1041
DP
DP
ODE May 31, 2014
N 021148 009 5849700 Dec 15, 2015
5849704 Dec 15, 2015
6899699 Jan 02, 2022
7686786 Aug 03, 2026
SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO
U-1041
DP U-1041
DP
DP
ODE May 31, 2014
N 021148 010 5849700 Dec 15, 2015
5849704 Dec 15, 2015
6899699 Jan 02, 2022
7686786 Aug 03, 2026
SOMATROPIN RECOMBINANT - ZORBTIVE
U-1041
DP U-1041
DP
DP
ODE May 31, 2014
N 021597 004 5898030
SORAFENIB TOSYLATE - NEXAVAR
Apr 27, 2016 DP
N 021923 001 7235576
7351834
7897623
8124630
Jan 12, 2020
Jan 12, 2020
Jan 12, 2020
Jul 13, 2022
DS DP
DS
DP
U-1459
I-677
ODE
ODE
Nov 22, 2016
Nov 16, 2014
Nov 22, 2020
SOTALOL HYDROCHLORIDE - SOTALOL HYDROCHLORIDE
N 022306 001 ODE Jul 02, 2016
SPINOSAD - NATROBA
N 022408 001 6063771
6342482
7030095
Jun 22, 2019
Jun 22, 2019
Jul 02, 2021
DP U-1105
DP U-1105
DP U-1105
NCE Jan 18, 2016
STAVUDINE - ZERIT XR
N 021453 001 7135465 Feb 18, 2023 DP U-167
STAVUDINE - ZERIT XR
N 021453 002 7135465 Feb 18, 2023 DP U-167
STAVUDINE - ZERIT XR
N 021453 003 7135465 Feb 18, 2023 DP U-167
STAVUDINE - ZERIT XR
N 021453 004 7135465 Feb 18, 2023 DP U-167
SUCROFERRIC OXYHYDROXIDE - VELPHORO
N 205109 001 6174442 Dec 19, 2016 DS U-1468 NP Nov 27, 2016
SUMATRIPTAN - IMITREX
N 020626 001 5554639
SUMATRIPTAN - IMITREX
Sep 10, 2013 U-232
N 020626 002 5554639
SUMATRIPTAN - IMITREX
Sep 10, 2013 U-232
N 020626 003 5554639 Sep 10, 2013
SUMATRIPTAN SUCCINATE - SUMAVEL DOSEPRO
U-232
N 022239 001 5891086
5957886
6135979
7776007
7901385
8118771
8241243
8241244
8267903
8287489
8343130
Jul 27, 2014
Mar 08, 2016
Mar 21, 2017
Nov 22, 2026
Jul 31, 2026
Aug 10, 2023
Dec 25, 2025
Nov 21, 2022
Mar 18, 2023
Dec 06, 2024
Oct 18, 2022
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
SUMATRIPTAN SUCCINATE - ALSUMA
N 022377 001 7811254 Aug 26, 2027 DP U-1083
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 191 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SUMATRIPTAN SUCCINATE - ZECUITY
N 202278 001 6745071
7973058
8155737
8366600
8470853
8597272
SUNITINIB MALATE - SUTENT
Feb 21, 2023
Apr 12, 2027
Apr 12, 2027
Apr 21, 2029
Apr 12, 2027
Apr 12, 2027
DP
U-1328
U-1328
U-1327
U-1328
DP
NDF Jan 17, 2016
N 021938 001 6573293
7125905
7211600
Feb 15, 2021
Feb 15, 2021
Dec 22, 2020
DS DP U-1154
DS DP
U-883
I-639 May 20, 2014
SUNITINIB MALATE - SUTENT
N 021938 002 6573293
7125905
7211600
Feb 15, 2021
Feb 15, 2021
Dec 22, 2020
DS DP U-1154
DS DP
U-883
I-639 May 20, 2014
SUNITINIB MALATE - SUTENT
N 021938 003 6573293
7125905
7211600
Feb 15, 2021
Feb 15, 2021
Dec 22, 2020
DS DP U-1154
DS DP
U-883
I-639 May 20, 2014
SUNITINIB MALATE - SUTENT
N 021938 004 6573293
7125905
7211600
Feb 15, 2021
Feb 15, 2021
Dec 22, 2020
DS DP U-1154
DS DP
U-883
I-639 May 20, 2014
TACROLIMUS - PROTOPIC
N 050777 001 5665727
TACROLIMUS - PROTOPIC
Sep 09, 2014 U-919
N 050777 002 5665727 Sep 09, 2014 U-919
TACROLIMUS - ASTAGRAF XL
N 204096 001 6440458
6576259
6884433
8551522
Mar 25, 2019
Mar 25, 2019
Mar 25, 2019
Mar 25, 2019
DP
DP U-1420
DP U-1420
DP
NDF Jul 19, 2016
TACROLIMUS - ASTAGRAF XL
N 204096 002 6440458
6576259
6884433
8551522
Mar 25, 2019
Mar 25, 2019
Mar 25, 2019
Mar 25, 2019
DP
DP U-1420
DP U-1420
DP
NDF Jul 19, 2016
TACROLIMUS - ASTAGRAF XL
N 204096 003 6440458
6576259
6884433
8551522
Mar 25, 2019
Mar 25, 2019
Mar 25, 2019
Mar 25, 2019
DP
DP U-1420
DP U-1420
DP
NDF Jul 19, 2016
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 192 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TADALAFIL - CIALIS
N 021368 001 5859006
6140329
6140329
6821975
6821975
6821975
6943166
6943166
6943166
7182958
7182958
TADALAFIL - CIALIS
Nov 21, 2017
Jul 11, 2016
Jul 11, 2016
Nov 19, 2020
Nov 19, 2020
Nov 19, 2020
Apr 26, 2020
Apr 26, 2020
Apr 26, 2020
Apr 26, 2020
Apr 26, 2020
DS DP
DP U-155
DP U-1184
DS DP U-533
DS DP U-614
DS DP U-1184
U-155
U-614
U-1184
DP U-155
DP U-1184
I-641
I-642
Oct 06, 2014
Oct 06, 2014
N 021368 002 5859006
6140329
6821975
6821975
6943166
6943166
7182958
TADALAFIL - CIALIS
Nov 21, 2017
Jul 11, 2016
Nov 19, 2020
Nov 19, 2020
Apr 26, 2020
Apr 26, 2020
Apr 26, 2020
DS DP
DP U-155
DS DP U-533
DS DP U-614
U-155
U-614
DP U-155
I-641
I-642
Oct 06, 2014
Oct 06, 2014
N 021368 003 5859006
6140329
6821975
6821975
6943166
7182958
TADALAFIL - CIALIS
Nov 21, 2017
Jul 11, 2016
Nov 19, 2020
Nov 19, 2020
Apr 26, 2020
Apr 26, 2020
DS DP
DP U-155
DS DP U-533
DS DP U-614
U-614
DP U-155
I-641
I-642
Oct 06, 2014
Oct 06, 2014
N 021368 004 5859006
6140329
6821975
6821975
6943166
7182958
Nov 21, 2017
Jul 11, 2016
Nov 19, 2020
Nov 19, 2020
Apr 26, 2020
Apr 26, 2020
DS DP
DP U-155
DS DP U-533
DS DP U-614
U-155
DP U-155
I-641
I-642
Oct 06, 2014
Oct 06, 2014
TADALAFIL - ADCIRCA
N 022332 001 5859006
6821975
7182958
Nov 21, 2017
Nov 19, 2020
Apr 26, 2020
DS DP U-975
DS DP
DP
ODE May 22, 2016
TAFLUPROST - ZIOPTAN
N 202514 001 5886035 Dec 18, 2017 DS DP U-778 NCE Feb 10, 2017
TALIGLUCERASE ALFA - ELELYSO
N 022458 001 8227230 Feb 24, 2024 DS DP NCE May 01, 2017
TAMOXIFEN CITRATE - SOLTAMOX
N 021807 001 6127425 Jun 26, 2018 DP
TAPENTADOL HYDROCHLORIDE - NUCYNTA
N 022304 001 6071970 Jun 06, 2017
7994364 Jun 27, 2025
RE39593 Aug 05, 2022
TAPENTADOL HYDROCHLORIDE - NUCYNTA
U-931
DS DP U-931
DS DP U-931
NCE Nov 20, 2013
N 022304 002 6071970 Jun 06, 2017
7994364 Jun 27, 2025
RE39593 Aug 05, 2022
TAPENTADOL HYDROCHLORIDE - NUCYNTA
U-931
DS DP U-931
DS DP U-931
NCE Nov 20, 2013
N 022304 003 6071970
7994364
RE39593
Jun 06, 2017
Jun 27, 2025
Aug 05, 2022
U-931
DS DP U-931
DS DP U-931
NCE Nov 20, 2013
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 193 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TAPENTADOL HYDROCHLORIDE - NUCYNTA ER
N 200533 001 6071970 Jun 06, 2017
6071970 Jun 06, 2017
7994364 Jun 27, 2025
7994364 Jun 27, 2025
8075872 Nov 20, 2023
8114383 Oct 10, 2024
8309060 Nov 20, 2023
8309060 Nov 20, 2023
8420056 Nov 20, 2023
8536130 Sep 22, 2028
RE39593 Aug 05, 2022
RE39593 Aug 05, 2022
TAPENTADOL HYDROCHLORIDE - NUCYNTA ER
U-1178
U-1276
DS DP U-1178
DS DP U-1276
DP
DP
DP U-1178
DP U-1276
DP
U-1276
DS DP U-1178
DS DP U-1276
Y
I-656
NCE
NDF
Aug 28, 2015
Nov 20, 2013
Aug 25, 2014
N 200533 002 6071970 Jun 06, 2017
6071970 Jun 06, 2017
7994364 Jun 27, 2025
7994364 Jun 27, 2025
8075872 Nov 20, 2023
8114383 Oct 10, 2024
8309060 Nov 20, 2023
8309060 Nov 20, 2023
8420056 Nov 20, 2023
8536130 Sep 22, 2028
RE39593 Aug 05, 2022
RE39593 Aug 05, 2022
TAPENTADOL HYDROCHLORIDE - NUCYNTA ER
U-1178
U-1276
DS DP U-1178
DS DP U-1276
DP
DP
DP U-1178
DP U-1276
DP
U-1276
DS DP U-1178
DS DP U-1276
Y
I-656
NCE
NDF
Aug 28, 2015
Nov 20, 2013
Aug 25, 2014
N 200533 003 6071970 Jun 06, 2017
6071970 Jun 06, 2017
7994364 Jun 27, 2025
7994364 Jun 27, 2025
8075872 Nov 20, 2023
8114383 Oct 10, 2024
8309060 Nov 20, 2023
8309060 Nov 20, 2023
8420056 Nov 20, 2023
8536130 Sep 22, 2028
RE39593 Aug 05, 2022
RE39593 Aug 05, 2022
TAPENTADOL HYDROCHLORIDE - NUCYNTA ER
U-1178
U-1276
DS DP U-1178
DS DP U-1276
DP
DP
DP U-1178
DP U-1276
DP
U-1276
DS DP U-1178
DS DP U-1276
Y
I-656
NCE
NDF
Aug 28, 2015
Nov 20, 2013
Aug 25, 2014
N 200533 004 6071970 Jun 06, 2017
6071970 Jun 06, 2017
7994364 Jun 27, 2025
7994364 Jun 27, 2025
8075872 Nov 20, 2023
8114383 Oct 10, 2024
8309060 Nov 20, 2023
8309060 Nov 20, 2023
8420056 Nov 20, 2023
8536130 Sep 22, 2028
RE39593 Aug 05, 2022
RE39593 Aug 05, 2022
TAPENTADOL HYDROCHLORIDE - NUCYNTA ER
U-1178
U-1276
DS DP U-1178
DS DP U-1276
DP
DP
DP U-1178
DP U-1276
DP
U-1276
DS DP U-1178
DS DP U-1276
Y
I-656
NCE
NDF
Aug 28, 2015
Nov 20, 2013
Aug 25, 2014
N 200533 005 6071970
6071970
7994364
7994364
8075872
8114383
8309060
8309060
8420056
8536130
RE39593
RE39593
Jun 06, 2017
Jun 06, 2017
Jun 27, 2025
Jun 27, 2025
Nov 20, 2023
Oct 10, 2024
Nov 20, 2023
Nov 20, 2023
Nov 20, 2023
Sep 22, 2028
Aug 05, 2022
Aug 05, 2022
U-1178
U-1276
DS DP U-1178
DS DP U-1276
DP
DP
DP U-1178
DP U-1276
DP
U-1276
DS DP U-1178
DS DP U-1276
Y
I-656
NCE
NDF
Aug 28, 2015
Nov 20, 2013
Aug 25, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 194 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
PATENT
EXPIRATION
DATE
APPL/PROD
NO PATENT NO
TAPENTADOL HYDROCHLORIDE - NUCYNTA
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 203794 001 6071970
7994364
RE39593
TAZAROTENE - TAZORAC
Jun 06, 2017
Jun 27, 2025
Aug 05, 2022
U-1289
DS DP U-1289
DS DP U-1289
NCE Nov 20, 2013
N 020600 001 5914334
6258830
TAZAROTENE - TAZORAC
Jun 07, 2014
Jun 07, 2014
U-517
U-517
N 020600 002 5914334
6258830
TAZAROTENE - FABIOR
Jun 07, 2014
Jun 07, 2014
U-517
U-517
N 202428 001
TECHNETIUM TC-99M APCITIDE - ACUTECT
NDF May 11, 2015
N 020887 001 5645815 Jul 08, 2014
TECHNETIUM TC-99M MERTIATIDE KIT - TECHNESCAN MAG3
N 019882 001 5573748 Nov 12, 2013 DP
TECHNETIUM TC-99M SULFUR COLLOID KIT - AN-SULFUR COLLOID
N 017858 001
TECHNETIUM TC-99M TEBOROXIME KIT - CARDIOTEC
ODE Aug 13, 2019
N 019928 001 6056941 Jul 28, 2019
TECHNETIUM TC-99M TILMANOCEPT - LYMPHOSEEK KIT
DP
N 202207 001 6409990 May 12, 2020
TEDUGLUTIDE RECOMBINANT - GATTEX KIT
DS NCE Mar 13, 2018
N 203441 001 5789379
7056886
7847061
TELAPREVIR - INCIVEK
Apr 14, 2015
Sep 18, 2022
Nov 01, 2025
DS DP U-1320
DP U-1320
U-1320
NCE
ODE
Dec 21, 2017
Dec 21, 2019
N 201917 001 7820671 Feb 25, 2025
8431615 May 30, 2028
8529882 Aug 31, 2021
TELAVANCIN HYDROCHLORIDE - VIBATIV
DS DP
U-1398
U-1398
NCE May 23, 2016
N 022110 001 6635618 Sep 11, 2023
6858584 Aug 24, 2022
6872701 Jun 05, 2021
7008923 May 06, 2021
7208471 May 01, 2021
7351691 May 01, 2021
7531623 Jan 01, 2027
7544364 May 01, 2021
7700550 May 01, 2021
8101575 May 01, 2021
8158580 May 01, 2021
TELAVANCIN HYDROCHLORIDE - VIBATIV
DS DP U-728
DP
DP
U-1005
DS DP
DS DP U-728
DS
DP
U-282
DP
DP
I-673
NCE
Jun 21, 2016
Sep 11, 2014
N 022110 002 6635618
6858584
6872701
7008923
7208471
7351691
7531623
7544364
7700550
8101575
8158580
Sep 11, 2023
Aug 24, 2022
Jun 05, 2021
May 06, 2021
May 01, 2021
May 01, 2021
Jan 01, 2027
May 01, 2021
May 01, 2021
May 01, 2021
May 01, 2021
DS DP U-728
DP
DP
U-1005
DS DP
DS DP U-728
DS
DP
U-282
DP
DP
I-673
NCE
Jun 21, 2016
Sep 11, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 195 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TELBIVUDINE - TYZEKA
N 022011 001 6395716 Aug 10, 2019 U-782 M-124 Jan 28, 2016
6444652 Aug 10, 2019 U-782
6566344 Aug 10, 2019 U-782
6569837 Oct 25, 2020 U-782
6569837 Oct 25, 2020 U-999
7589079 Sep 11, 2023 DS DP U-999
7795238 Aug 10, 2019 U-999
7858594 Sep 11, 2023 DS DP U-999
TELBIVUDINE - TYZEKA
N 022154 001 6395716 Aug 10, 2019 U-999 M-124 Jan 28, 2016
6444652 Aug 10, 2019 U-999
6566344 Aug 10, 2019 U-999
6569837 Oct 25, 2020 U-999
7795238 Aug 10, 2019 U-999
7858594 Sep 11, 2023 DS DP U-999
TELITHROMYCIN - KETEK
N 021144 001 5635485 Apr 01, 2018 DS DP U-578
D459798 Sep 24, 2015 DP
TELITHROMYCIN - KETEK
N 021144 002 5635485 Apr 01, 2018 DS DP U-578
D459798 Sep 24, 2015 DP
TELMISARTAN - MICARDIS
N 020850 001 5591762 Jan 07, 2014 U-3
6358986 Jan 10, 2020
TELMISARTAN - MICARDIS
N 020850 002 5591762 Jan 07, 2014 DS DP U-3
6358986 Jan 10, 2020
7998953 Jun 06, 2020 U-1177
8003679 Oct 06, 2022 U-1176
TELMISARTAN - MICARDIS
N 020850 003 5591762 Jan 07, 2014 U-3
6358986 Jan 10, 2020
TEMOZOLOMIDE - TEMODAR
N 021029 001 5260291 Aug 11, 2013 DS DP U-619
TEMOZOLOMIDE - TEMODAR
N 021029 002 5260291 Aug 11, 2013 DS DP U-619
TEMOZOLOMIDE - TEMODAR
N 021029 003 5260291 Aug 11, 2013 DS DP U-619
TEMOZOLOMIDE - TEMODAR
N 021029 004 5260291 Aug 11, 2013 DS DP U-619
TEMOZOLOMIDE - TEMODAR
N 021029 005 5260291 Aug 11, 2013 DS DP U-619
TEMOZOLOMIDE - TEMODAR
N 021029 006 5260291 Aug 11, 2013 DS DP U-619
TEMOZOLOMIDE - TEMODAR
N 022277 001 5260291 Aug 11, 2013 DS DP U-619
6987108 Sep 08, 2023 DP
7786118 Feb 21, 2023 DP
TEMSIROLIMUS - TORISEL
N 022088 001 5362718 Apr 18, 2014 DS DP M-61 May 30, 2015
8026276 Jan 20, 2026 DP M-92 Jul 09, 2013
8299116 Jul 25, 2023 DP ODE May 30, 2014
8455539 Jul 25, 2023 DP PED Jan 09, 2014
8455539*PED Jan 25, 2024 PED Oct 26, 2013
PED Nov 30, 2014
PED Nov 30, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 196 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N 021356 001 5922695 Jul 25, 2017 DS U-248 M-128 Jul 24, 2016
5922695 Jul 25, 2017 DS U-250 M-95 Oct 01, 2013
5922695 Jul 25, 2017 DS U-256 NPP Jan 18, 2015
5922695 Jul 25, 2017 DS U-999 NPP Aug 16, 2015
5922695 Jul 25, 2017 DS U-1275 ODE Mar 24, 2017
5935946 Jul 25, 2017 DS DP U-248 PED Jul 18, 2015
5935946 Jul 25, 2017 DS DP U-250 PED Sep 24, 2013
5935946 Jul 25, 2017 DS DP U-256 PED Sep 24, 2017
5935946 Jul 25, 2017 DS DP U-999 PED Apr 01, 2014
5935946 Jul 25, 2017 DS DP U-1275
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-250
5977089 Jul 25, 2017 DS DP U-256
5977089 Jul 25, 2017 DS DP U-999
5977089 Jul 25, 2017 DS DP U-1275
6043230 Jul 25, 2017 U-248
6043230 Jul 25, 2017 U-250
6043230 Jul 25, 2017 U-256
6043230 Jul 25, 2017 U-999
6043230 Jul 25, 2017 U-1275
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N 021356 002 5922695 Jul 25, 2017 DS U-248 M-128 Jul 24, 2016
5922695 Jul 25, 2017 DS U-250 M-95 Oct 01, 2013
5922695 Jul 25, 2017 DS U-256 NPP Jan 18, 2015
5922695 Jul 25, 2017 DS U-999 NPP Aug 16, 2015
5922695 Jul 25, 2017 DS U-1275 ODE Mar 24, 2017
5935946 Jul 25, 2017 DS DP U-248 PED Sep 24, 2013
5935946 Jul 25, 2017 DS DP U-250 PED Jul 18, 2015
5935946 Jul 25, 2017 DS DP U-256 PED Sep 24, 2017
5935946 Jul 25, 2017 DS DP U-999 PED Apr 01, 2014
5935946 Jul 25, 2017 DS DP U-1275
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-250
5977089 Jul 25, 2017 DS DP U-256
5977089 Jul 25, 2017 DS DP U-999
5977089 Jul 25, 2017 DS DP U-1275
6043230 Jul 25, 2017 U-248
6043230 Jul 25, 2017 U-250
6043230 Jul 25, 2017 U-256
6043230 Jul 25, 2017 U-999
6043230 Jul 25, 2017 U-1275
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N 021356 003 5922695 Jul 25, 2017 DS U-248 M-128 Jul 24, 2016
5922695 Jul 25, 2017 DS U-250 M-95 Oct 01, 2013
5922695 Jul 25, 2017 DS U-256 NPP Aug 16, 2015
5922695 Jul 25, 2017 DS U-999 NPP Jan 18, 2015
5922695 Jul 25, 2017 DS U-1275 ODE Mar 24, 2017
5935946 Jul 25, 2017 DS DP U-248 PED Sep 24, 2017
5935946 Jul 25, 2017 DS DP U-250 PED Apr 01, 2014
5935946 Jul 25, 2017 DS DP U-256 PED Sep 24, 2013
5935946 Jul 25, 2017 DS DP U-999 PED Jul 18, 2015
5935946 Jul 25, 2017 DS DP U-1275
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-250
5977089 Jul 25, 2017 DS DP U-256
5977089 Jul 25, 2017 DS DP U-999
5977089 Jul 25, 2017 DS DP U-1275
6043230 Jul 25, 2017 U-248
6043230 Jul 25, 2017 U-250
6043230 Jul 25, 2017 U-256
6043230 Jul 25, 2017 U-999
6043230 Jul 25, 2017 U-1275
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 197 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
NO PATENT NO EXPIRATION
DATE
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N 021356 004 5922695 Jul 25, 2017
5922695 Jul 25, 2017
5922695 Jul 25, 2017
5922695 Jul 25, 2017
5922695 Jul 25, 2017
5935946 Jul 25, 2017
5935946 Jul 25, 2017
5935946 Jul 25, 2017
5935946 Jul 25, 2017
5935946 Jul 25, 2017
5977089 Jul 25, 2017
5977089 Jul 25, 2017
5977089 Jul 25, 2017
5977089 Jul 25, 2017
5977089 Jul 25, 2017
6043230 Jul 25, 2017
6043230 Jul 25, 2017
6043230 Jul 25, 2017
6043230 Jul 25, 2017
6043230 Jul 25, 2017
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N 022577 001 5922695 Jul 25, 2017
5922695 Jul 25, 2017
5922695 Jul 25, 2017
5922695 Jul 25, 2017
5922695 Jul 25, 2017
5935946 Jul 25, 2017
5935946 Jul 25, 2017
5935946 Jul 25, 2017
5935946 Jul 25, 2017
5935946 Jul 25, 2017
5977089 Jul 25, 2017
5977089 Jul 25, 2017
5977089 Jul 25, 2017
5977089 Jul 25, 2017
5977089 Jul 25, 2017
6043230 Jul 25, 2017
6043230 Jul 25, 2017
6043230 Jul 25, 2017
6043230 Jul 25, 2017
6043230 Jul 25, 2017
TERBINAFINE - LAMISIL
N 020846 001 5681849 Oct 28, 2014
TERBINAFINE - LAMISIL AT
N 021958 001 5681849 Oct 28, 2014
TERBINAFINE HYDROCHLORIDE - LAMISIL AT
N 021124 001 5681849 Oct 28, 2014
TERBINAFINE HYDROCHLORIDE - LAMISIL AT
N 021124 002 5681849 Oct 28, 2014
TERIFLUNOMIDE - AUBAGIO
N 202992 001 5679709 Oct 21, 2014
6794410 Apr 15, 2022
TERIFLUNOMIDE - AUBAGIO
N 202992 002 5679709 Oct 21, 2014
6794410 Apr 15, 2022
PATENT
PATENT DELIST
CODES REQUESTED
DS U-248
DS U-250
DS U-256
DS U-999
DS U-1275
DS DP U-248
DS DP U-250
DS DP U-256
DS DP U-999
DS DP U-1275
DS DP U-248
DS DP U-250
DS DP U-256
DS DP U-999
DS DP U-1275
U-248
U-250
U-256
U-999
U-1275
DS U-248
DS U-250
DS U-256
DS U-999
DS U-1275
DS DP U-248
DS DP U-250
DS DP U-256
DS DP U-999
DS DP U-1275
DS DP U-248
DS DP U-250
DS DP U-256
DS DP U-999
DS DP U-1275
U-248
U-250
U-256
U-999
U-1275
DP
DP
DP U-1285
U-1285
DP U-1285
U-1285
EXCLUSIVITY
EXCLUSIVITY EXPIRATION
CODE(S) DATE
M-128 Jul 24, 2016
M-95 Oct 01, 2013
NPP Aug 16, 2015
NPP Jan 18, 2015
ODE Mar 24, 2017
PED Apr 01, 2014
PED Sep 24, 2013
PED Jul 18, 2015
PED Sep 24, 2017
M-128 Jul 24, 2016
M-95 Oct 01, 2013
NDF Jan 18, 2015
NPP Aug 16, 2015
ODE Mar 24, 2017
PED Sep 24, 2017
PED Apr 01, 2014
PED Sep 24, 2013
PED Jul 18, 2015
NCE Sep 12, 2017
NCE Sep 12, 2017
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 198 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TERIPARATIDE RECOMBINANT HUMAN - FORTEO
N 021318 001 6770623 Dec 08, 2018 DP U-597
6977077 Aug 19, 2019 U-597
7144861 Dec 08, 2018 DP
7163684 Aug 19, 2019 U-790
7351414 Aug 19, 2019 U-865
7550434 Dec 08, 2018 DP U-982
TERIPARATIDE RECOMBINANT HUMAN - FORTEO
N 021318 002 6770623 Dec 08, 2018 DP U-982
6977077 Aug 19, 2019 U-982
6977077 Aug 19, 2019 U-994
7144861 Dec 08, 2018 DP
7163684 Aug 19, 2019 U-983
7163684 Aug 19, 2019 U-994
7351414 Aug 19, 2019 U-984
7351414 Aug 19, 2019 U-994
7550434 Dec 08, 2018 DP U-982
TESAMORELIN ACETATE - EGRIFTA
N 022505 001 5861379 May 26, 2015 DS DP U-1100 NCE Nov 10, 2015
6020311 May 26, 2015 DS DP U-1100
7144577 Jul 14, 2020 U-1100
7316997 Aug 14, 2023 U-1100
TESAMORELIN ACETATE - EGRIFTA
N 022505 002 5861379 May 26, 2015 DS DP U-1100 NCE Nov 10, 2015
6020311 May 26, 2015 DS DP U-1100
7144577 Jul 14, 2020 U-1100
7316997 Aug 14, 2023 U-1100
TESTOSTERONE - TESTODERM
N 019762 001 5840327 Aug 15, 2016
TESTOSTERONE - TESTODERM
N 019762 002 5840327 Aug 15, 2016
TESTOSTERONE - ANDRODERM
N 020489 003 NS Oct 20, 2014
TESTOSTERONE - ANDRODERM
N 020489 004 NS Oct 20, 2014
TESTOSTERONE - TESTODERM TTS
N 020791 001 6348210 Nov 10, 2019 U-440
TESTOSTERONE - ANDROGEL
N 021015 001 6503894 Aug 30, 2020 U-490
TESTOSTERONE - ANDROGEL
N 021015 002 6503894 Aug 30, 2020 U-490
TESTOSTERONE - ANDROGEL
N 021015 003 6503894 Aug 30, 2020 U-490
TESTOSTERONE - TESTIM
N 021454 001 7320968 Jan 18, 2025 U-843
7608605 Apr 21, 2023 U-1009
7608606 Apr 21, 2023 U-1009
7608607 Apr 21, 2023 U-1009
7608608 Apr 21, 2023 U-1009
7608609 Apr 21, 2023 U-1009
7608610 Apr 21, 2023 U-1009
7935690 Apr 21, 2023 U-1009
8063029 Apr 21, 2023 U-843
8178518 Apr 21, 2023 DP
TESTOSTERONE - FORTESTA
N 021463 001 6319913 Nov 09, 2018 U-490 NP Dec 29, 2013
6579865 Nov 09, 2018 DP
TESTOSTERONE - STRIANT
N 021543 001 6248358 Aug 23, 2019 U-527
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 199 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
TESTOSTERONE - ANDROGEL
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 022309 001 6503894
8466136
8466137
8466138
8486925
Aug 30, 2020
Oct 12, 2026
Oct 12, 2026
Oct 12, 2026
Oct 12, 2026
U-1103
DP
U-1103
U-1103
DP
NP Apr 29, 2014
TESTOSTERONE - ANDROGEL
N 022309 002 8466136
8466137
8466138
8486925
Oct 12, 2026
Oct 12, 2026
Oct 12, 2026
Oct 12, 2026
DP
U-1103
U-1103
DP
NP Apr 29, 2014
TESTOSTERONE - ANDROGEL
N 022309 003 8466136
8466137
8466138
8486925
Oct 12, 2026
Oct 12, 2026
Oct 12, 2026
Oct 12, 2026
DP
U-1103
U-1103
DP
NP Apr 29, 2014
TESTOSTERONE - AXIRON
N 022504 001 6299900
6818226
6923983
8071075
8419307
8435944
Feb 19, 2017
Feb 19, 2017
Feb 19, 2017
Feb 19, 2017
Feb 26, 2027
Jul 05, 2027
DP U-1103
DP U-1103
DP U-1103
DP U-1103
U-1386
U-1390
NP Nov 23, 2013
TESTOSTERONE - TESTOSTERONE
N 202763 001 NP Feb 14, 2015
TESTOSTERONE - TESTOSTERONE
N 203098 001 NP Jan 31, 2016
TESTOSTERONE - TESTOSTERONE
N 203098 002 NP Jan 31, 2016
TESTOSTERONE - TESTOSTERONE
N 203098 003 NP Jan 31, 2016
TETRABENAZINE - XENAZINE
N 021894 001
TETRABENAZINE - XENAZINE
NCE
ODE
Aug 15, 2013
Aug 15, 2015
N 021894 002 NCE
ODE
Aug 15, 2013
Aug 15, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 200 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
THALIDOMIDE - THALOMID
N 020785 001 5629327 May 13, 2014 U-731
6045501 Aug 28, 2018 U-371
6045501 Aug 28, 2018 U-731
6315720 Oct 23, 2020 U-442
6315720 Oct 23, 2020 U-731
6561976 Aug 28, 2018 U-371
6561976 Aug 28, 2018 U-731
6561977 Oct 23, 2020 U-371
6561977 Oct 23, 2020 U-731
6755784 Oct 23, 2020 U-371
6755784 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-371
6869399 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-732
6869399 Oct 23, 2020 U-733
6908432 Aug 28, 2018 U-371
6908432 Aug 28, 2018 U-731
7141018 Oct 23, 2020 U-371
7141018 Oct 23, 2020 U-731
7141018 Oct 23, 2020 U-732
7141018 Oct 23, 2020 U-733
7230012 Dec 09, 2023 DP
7435745 Nov 03, 2017 U-899
7874984 Aug 28, 2018 U-371
7874984 Aug 28, 2018 U-442
7874984 Aug 28, 2018 U-732
7874984 Aug 28, 2018 U-733
7874984 Aug 28, 2018 U-1109
7959566 Oct 23, 2020 U-1155
8204763 Aug 28, 2018 U-1249
8315886 Oct 23, 2020 U-1249
8589188 Aug 28, 2018 U-1465
THALIDOMIDE - THALOMID
N 020785 002 5629327 May 13, 2014 U-731
6045501 Aug 28, 2018 U-371
6045501 Aug 28, 2018 U-731
6315720 Oct 23, 2020 U-442
6315720 Oct 23, 2020 U-731
6561976 Aug 28, 2018 U-371
6561976 Aug 28, 2018 U-731
6561977 Oct 23, 2020 U-371
6561977 Oct 23, 2020 U-731
6755784 Oct 23, 2020 U-371
6755784 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-371
6869399 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-732
6869399 Oct 23, 2020 U-733
6908432 Aug 28, 2018 U-371
6908432 Aug 28, 2018 U-731
7141018 Oct 23, 2020 U-371
7141018 Oct 23, 2020 U-731
7141018 Oct 23, 2020 U-732
7141018 Oct 23, 2020 U-733
7230012 Dec 09, 2023 DP
7435745 Nov 03, 2017 U-899
7874984 Aug 28, 2018 U-371
7874984 Aug 28, 2018 U-442
7874984 Aug 28, 2018 U-732
7874984 Aug 28, 2018 U-733
7874984 Aug 28, 2018 U-1109
7959566 Oct 23, 2020 U-1155
8204763 Aug 28, 2018 U-1249
8315886 Oct 23, 2020 U-1249
8589188 Aug 28, 2018 U-1465
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 201 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
THALIDOMIDE - THALOMID
N 020785 003 5629327 May 13, 2014 U-731
6045501 Aug 28, 2018 U-371
6045501 Aug 28, 2018 U-731
6315720 Oct 23, 2020 U-442
6315720 Oct 23, 2020 U-731
6561976 Aug 28, 2018 U-371
6561976 Aug 28, 2018 U-731
6561977 Oct 23, 2020 U-371
6561977 Oct 23, 2020 U-731
6755784 Oct 23, 2020 U-371
6755784 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-371
6869399 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-732
6869399 Oct 23, 2020 U-733
6908432 Aug 28, 2018 U-371
6908432 Aug 28, 2018 U-731
7141018 Oct 23, 2020 U-371
7141018 Oct 23, 2020 U-731
7141018 Oct 23, 2020 U-732
7141018 Oct 23, 2020 U-733
7230012 Dec 09, 2023 DP
7435745 Nov 03, 2017 U-899
7874984 Aug 28, 2018 U-371
7874984 Aug 28, 2018 U-442
7874984 Aug 28, 2018 U-732
7874984 Aug 28, 2018 U-733
7874984 Aug 28, 2018 U-1109
7959566 Oct 23, 2020 U-1155
8204763 Aug 28, 2018 U-1249
8315886 Oct 23, 2020 U-1249
8589188 Aug 28, 2018 U-1465
THALIDOMIDE - THALOMID
N 020785 004 5629327 May 13, 2014 U-731
6045501 Aug 28, 2018 U-731
6315720 Oct 23, 2020 U-731
6561976 Aug 28, 2018 U-731
6561977 Oct 23, 2020 U-731
6755784 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-731
6908432 Aug 28, 2018 U-731
7141018 Oct 23, 2020 U-731
7435745 Nov 03, 2017 U-899
7874984 Aug 28, 2018 U-371
7874984 Aug 28, 2018 U-442
7874984 Aug 28, 2018 U-732
7874984 Aug 28, 2018 U-733
7874984 Aug 28, 2018 U-1109
7959566 Oct 23, 2020 U-1155
8204763 Aug 28, 2018 U-1249
8315886 Oct 23, 2020 U-1249
8589188 Aug 28, 2018 U-1465
THYROTROPIN ALFA - THYROGEN
N 020898 001 5840566 Nov 24, 2015 ODE Dec 14, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 202 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TIAGABINE HYDROCHLORIDE - GABITRIL
N 020646 001 5866590
5958951
Apr 29, 2016
Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N 020646 002 5866590
5958951
Apr 29, 2016
Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N 020646 003 5866590
5958951
Apr 29, 2016
Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N 020646 004 5866590
5958951
Apr 29, 2016
Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N 020646 005 5866590
5958951
Apr 29, 2016
Jun 10, 2017
TICAGRELOR - BRILINTA
N 022433 001 6251910
6525060
7250419
7265124
8425934
Jul 15, 2018
Dec 02, 2019
Dec 02, 2019
Jul 09, 2021
Dec 18, 2029
DS
DS DP U-1171
DS DP U-1171
DS DP U-1171
DP
NCE Jul 20, 2016
TIGECYCLINE - TYGACIL
N 021821 001 7879828 Feb 05, 2029
8372995 Oct 08, 2030
RE40183 Apr 09, 2016
TIMOLOL MALEATE - TIMOLOL MALEATE
DP
DP
DS DP
N 020963 001 6174524 Mar 26, 2019 DP
TIMOLOL MALEATE - TIMOLOL MALEATE
N 020963 002 6174524 Mar 26, 2019 DP
TIMOLOL MALEATE - ISTALOL
N 021516 001 6335335
6645963
Nov 02, 2018
Nov 02, 2018
DP
DP
TIOTROPIUM BROMIDE MONOHYDRATE - SPIRIVA
N 021395 001 6777423
6908928
6908928
7070800
7309707
7642268
7694676
8022082
RE38912
RE39820
Sep 24, 2021
Sep 24, 2021
Sep 24, 2021
Jan 22, 2022
Sep 24, 2021
Sep 24, 2021
Mar 12, 2027
Jan 19, 2026
Oct 11, 2021
Jan 30, 2018
DS DP
DS DP U-566
DS DP U-762
DP U-566
DS DP
DS DP
DP
DP U-1186
DP
DS DP U-566
TIPRANAVIR - APTIVUS
N 021814 001 5852195
6147095
6169181
6231887
Jun 22, 2019
Oct 29, 2019
May 06, 2014
Jul 27, 2018
DS
U-670
DS
DP
TIPRANAVIR - APTIVUS
N 022292 001 5852195
6147095
6169181
Jun 22, 2019
Oct 29, 2019
May 06, 2014
DS
DS
U-670
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 203 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N 020912 001 5733919 Oct 23, 2016
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
6770660 May 01, 2023
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N 020913 001 5733919 Oct 23, 2016
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
6770660 Jun 01, 2023
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N 020913 002 5733919 Oct 23, 2016
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
6770660 Jun 01, 2023
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N 020913 003 5733919 Oct 23, 2016
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
6770660 Jun 01, 2023
TOBRAMYCIN - TOBI
N 050753 001 5508269 Oct 19, 2014 DP U-909
TOBRAMYCIN - TOBI PODHALER
N 201688 001 7097827 Apr 16, 2016 DP NP Mar 22, 2016
7368102 Dec 19, 2022 DP U-909
7442388 May 10, 2020 DP
7516741 Jan 11, 2024 DP
7559325 Oct 27, 2025 DP
8069851 Sep 24, 2024 DP
8349294 May 10, 2020 DP
TOBRAMYCIN - BETHKIS
N 201820 001 6987094 Sep 22, 2022 DP
7696178 Mar 17, 2023 DP
7939502 Jun 14, 2022 U-1324
TOFACITINIB CITRATE - XELJANZ
N 203214 001 6956041 Dec 08, 2020 DP NCE Nov 06, 2017
6965027 Mar 25, 2023 DS
7091208 Dec 08, 2020 U-247
7265221 Dec 08, 2020 DS
7301023 May 23, 2022 DS
RE41783 Dec 08, 2020 DS
TOLTERODINE TARTRATE - DETROL LA
N 021228 001 6630162 Nov 11, 2019 DP U-544
6770295 Aug 26, 2019 DP U-544
6911217 Nov 11, 2019 DP U-544
6911217*PED May 11, 2020
TOLTERODINE TARTRATE - DETROL LA
N 021228 002 6630162 Nov 11, 2019 DP U-544
6770295 Aug 26, 2019 DP U-544
6911217 Nov 11, 2019 DP U-544
6911217*PED May 11, 2020
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 204 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TOLVAPTAN - SAMSCA
N 022275 001 5258510 Nov 02, 2013 DS DP NCE May 19, 2014
5753677 May 19, 2015 U-978
8501730 Sep 01, 2026 DS
TOLVAPTAN - SAMSCA
N 022275 002 5258510 Nov 02, 2013 DS DP NCE May 19, 2014
5753677 May 19, 2015 U-978
8501730 Sep 01, 2026 DS
TOLVAPTAN - SAMSCA
N 022275 003 5258510 Nov 02, 2013 DS DP NCE May 19, 2014
5753677 May 19, 2015 U-978
8501730 Sep 01, 2026 DS
TOPIRAMATE - TOPAMAX
N 020505 001 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020505 002 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020505 003 5998380 Oct 13, 2015 U-598
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020505 004 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020505 005 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020505 006 5998380 Oct 13, 2015 U-598
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020844 001 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7125560 Mar 01, 2019 U-766
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020844 002 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7125560 Mar 01, 2019 U-766
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX SPRINKLE
N 020844 003 5998380 Oct 13, 2015 U-598
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7125560 Mar 01, 2019 U-766
7498311 Oct 13, 2015 U-955
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 205 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TOPIRAMATE - TROKENDI XR
N 201635 001 8298576
8298580
Mar 18, 2029
Nov 16, 2027
DP U-106
DP U-106
TOPIRAMATE - TROKENDI XR
N 201635 002 8298576
8298580
Mar 18, 2029
Nov 16, 2027
DP U-106
DP U-106
TOPIRAMATE - TROKENDI XR
N 201635 003 8298576
8298580
Mar 18, 2029
Nov 16, 2027
DP U-106
DP U-106
TOPIRAMATE - TROKENDI XR
N 201635 004 8298576
8298580
Mar 18, 2029
Nov 16, 2027
DP U-106
DP U-106
TOPOTECAN HYDROCHLORIDE - HYCAMTIN
N 020671 001 5674872 Oct 07, 2014 U-910
TOPOTECAN HYDROCHLORIDE - HYCAMTIN
N 020981 001 8158645 Dec 10, 2024 DP
TOPOTECAN HYDROCHLORIDE - HYCAMTIN
N 020981 002 8158645 Dec 10, 2024 DP
TRAMADOL HYDROCHLORIDE - ULTRAM
N 020281 001 6339105 Oct 12, 2019 U-435
TRAMADOL HYDROCHLORIDE - ULTRAM
N 020281 002 6339105 Oct 12, 2019 U-435
TRAMADOL HYDROCHLORIDE - RYBIX ODT
N 021693 001 6106861 Dec 05, 2017 DP
TRAMADOL HYDROCHLORIDE - RYZOLT
N 021745 001 5591452
6254887
6607748
7988998
May 10, 2014
May 10, 2014
Jun 29, 2020
Oct 27, 2023
DP
DP
DP
DP
TRAMADOL HYDROCHLORIDE - RYZOLT
N 021745 002 5591452
6254887
6607748
7988998
May 10, 2014
May 10, 2014
Jun 29, 2020
Oct 27, 2023
DP
DP
DP
DP
TRAMADOL HYDROCHLORIDE - RYZOLT
N 021745 003 5591452
6254887
6607748
7988998
May 10, 2014
May 10, 2014
Jun 29, 2020
Oct 27, 2023
DP
DP
DP
DP
TRAMADOL HYDROCHLORIDE - CONZIP
N 022370 001 7858118 Apr 11, 2022 DP U-1104
TRAMADOL HYDROCHLORIDE - CONZIP
N 022370 002 7858118 Apr 11, 2022 DP U-1104
TRAMADOL HYDROCHLORIDE - CONZIP
N 022370 003 7858118 Apr 11, 2022 DP U-1104
TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST
N 204114 001 7378423
8580304
Sep 13, 2025
Jan 28, 2032
DS DP
DP
NCE
ODE
May 29, 2018
May 29, 2020
TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST
N 204114 002 7378423
8580304
Sep 13, 2025
Jan 28, 2032
DS DP
DP
NCE
ODE
May 29, 2018
May 29, 2020
TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST
N 204114 003 7378423
8580304
Sep 13, 2025
Jan 28, 2032
DS DP
DP
NCE
ODE
May 29, 2018
May 29, 2020
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 206 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TRANDOLAPRIL - MAVIK
N 020528 001 5744496
TRANDOLAPRIL - MAVIK
Apr 28, 2015 U-229
N 020528 002 5744496
TRANDOLAPRIL - MAVIK
Apr 28, 2015 U-229
N 020528 003 5744496 Apr 28, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N 020591 001 5721244 Feb 24, 2015
U-229
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N 020591 002 5721244 Feb 24, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N 020591 003 5721244 Feb 24, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N 020591 004 5721244 Feb 24, 2015
TRANEXAMIC ACID - TRANEXAMIC ACID
A 202093 001 PC Jul 02, 2013
TRANEXAMIC ACID - LYSTEDA
N 022430 001 7947739
8022106
8273795
8487005
Mar 04, 2025
Mar 04, 2025
Mar 04, 2025
Mar 04, 2025
DP
U-1182
U-1182
DP U-1182
TRAVOPROST - TRAVATAN
N 021257 001 5510383
5631287
5849792
5889052
6011062
Aug 03, 2013
Dec 22, 2014
Dec 22, 2014
Dec 02, 2014
Dec 22, 2014
DP U-383
U-382
DP U-383
DP U-383
DP
TRAVOPROST - TRAVATAN Z
N 021994 001 5510383 Aug 03, 2013
5889052 Dec 02, 2014
8268299 Oct 13, 2029
8323630 Sep 20, 2027
8388941 Sep 20, 2027
TRAZODONE HYDROCHLORIDE - OLEPTRO
DP U-383
DP U-383
DP
DP
DP
N 022411 001 6607748
7829120
8133893
Jun 29, 2020
Mar 27, 2027
Mar 13, 2029
DP
DP U-796
DS DP
TRAZODONE HYDROCHLORIDE - OLEPTRO
N 022411 002 6607748
7829120
8133893
Jun 29, 2020
Mar 27, 2027
Mar 13, 2029
DP
DP U-796
DS DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 207 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
TREPROSTINIL - REMODULIN
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
N 021272 001 5153222
6765117
7999007
8497393
TREPROSTINIL - REMODULIN
Oct 06, 2014
Oct 24, 2017
Mar 29, 2029
Dec 15, 2028
U-455
DS
DP U-1437
DS
N 021272 002 5153222
6765117
7999007
8497393
TREPROSTINIL - REMODULIN
Oct 06, 2014
Oct 24, 2017
Mar 29, 2029
Dec 15, 2028
U-455
DS
DP U-1437
DS
N 021272 003 5153222
6765117
7999007
8497393
TREPROSTINIL - REMODULIN
Oct 06, 2014
Oct 24, 2017
Mar 29, 2029
Dec 15, 2028
U-455
DS
DP U-1437
DS
N 021272 004 5153222
6765117
7999007
8497393
TREPROSTINIL - TYVASO
Oct 06, 2014
Oct 24, 2017
Mar 29, 2029
Dec 15, 2028
U-455
DS
DP U-1437
DS
N 022387 001 5153222
6521212
6756033
6765117
8497393
TREPROSTINIL - ORENITRAM
Oct 16, 2014
Nov 13, 2018
Nov 13, 2018
Oct 24, 2017
Dec 15, 2028
DS
DS
U-1019
U-1018
U-1018
ODE Jul 30, 2016
N 203496 001 5153222
6765117
7417070
7544713
8252839
8349892
8410169
8497393
TREPROSTINIL - ORENITRAM
Oct 16, 2014
Oct 24, 2017
Aug 30, 2026
Jul 14, 2024
May 24, 2024
Jan 22, 2031
Feb 13, 2030
Dec 15, 2028
U-1475
DS
DS
U-1475
DP
DP
DP
DS
NDF Dec 20, 2016
N 203496 002 5153222
6765117
7417070
7544713
8252839
8349892
8410169
8497393
TREPROSTINIL - ORENITRAM
Oct 16, 2014
Oct 24, 2017
Aug 30, 2026
Jul 14, 2024
May 24, 2024
Jan 22, 2031
Feb 13, 2030
Dec 15, 2028
U-1475
DS
DS
DP
DP
DP
DS
NDF Dec 20, 2016
N 203496 003 5153222
6765117
7417070
7544713
8252839
8349892
8410169
8497393
TREPROSTINIL - ORENITRAM
Oct 16, 2014
Oct 24, 2017
Aug 30, 2026
Jul 14, 2024
May 24, 2024
Jan 22, 2031
Feb 13, 2030
Dec 15, 2028
U-1475
DS
DS
DP
DP
DP
DS
NDF Dec 20, 2016
N 203496 004 5153222
6765117
7417070
7544713
8252839
8349892
8410169
8497393
Oct 16, 2014
Oct 24, 2017
Aug 30, 2026
Jul 14, 2024
May 24, 2024
Jan 22, 2031
Feb 13, 2030
Dec 15, 2028
U-1475
DS
DS
DP
DP
DP
DS
NDF Dec 20, 2016
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 208 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TRETINOIN - RETIN-A MICRO
N 020475 001 5955109 Sep 21, 2016 DP U-134
TRETINOIN - RETIN-A MICRO
N 020475 002 5955109 Sep 21, 2016 U-134
TRETINOIN - RENOVA
N 021108 001 6531141 Mar 07, 2020
TRETINOIN - ATRALIN
N 022070 001 5670547 Sep 23, 2014 DP
TRIAMCINOLONE ACETONIDE - NASACORT ALLERGY 24 HOUR
N 020468 002 5976573 Jul 03, 2016 DP
6143329 Jul 03, 2016 DP
7977045 Jul 03, 2016 DP
TRIAMCINOLONE ACETONIDE - TRIESENCE
N 022048 001 6395294 Jan 13, 2020 DP U-846
8128960 Dec 17, 2029 DP
8211880 Mar 10, 2029 U-1257
8211880 Mar 10, 2029 U-1258
TRIMETHOPRIM HYDROCHLORIDE - PRIMSOL
N 074973 001 5763449 Aug 07, 2016
5962461 Aug 07, 2016
TRIMETREXATE GLUCURONATE - NEUTREXIN
N 020326 001 6017922 May 18, 2018
TRIMETREXATE GLUCURONATE - NEUTREXIN
N 020326 002 6017922 May 18, 2018
TRIPTORELIN PAMOATE - TRELSTAR
N 020715 001 5776885 Jul 07, 2015
TRIPTORELIN PAMOATE - TRELSTAR
N 021288 001 5776885 Jul 07, 2015 DP
TRIPTORELIN PAMOATE - TRELSTAR
N 022437 001 5776885 Jul 07, 2015 DP
TROGLITAZONE - PRELAY
N 020719 001 5602133 Sep 15, 2013 U-173
5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
6046202 Sep 15, 2013 U-317
TROGLITAZONE - PRELAY
N 020719 002 5602133 Sep 15, 2013 U-173
5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
6046202 Sep 15, 2013 U-317
TROGLITAZONE - PRELAY
N 020719 003 5602133 Sep 15, 2013 U-173
5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
6046202 Sep 15, 2013 U-317
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 209 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TROGLITAZONE - REZULIN
N 020720 001 5602133
5859037
6011049
6046202
TROGLITAZONE - REZULIN
Sep 15, 2013
Nov 13, 2017
Nov 13, 2017
Sep 15, 2013
U-173
U-251
U-301
U-317
N 020720 002 5602133
5859037
6011049
6046202
TROGLITAZONE - REZULIN
Sep 15, 2013
Nov 13, 2017
Nov 13, 2017
Sep 15, 2013
U-173
U-251
U-301
U-317
N 020720 003 5602133
5859037
6011049
6046202
Sep 15, 2013
Nov 13, 2017
Nov 13, 2017
Sep 15, 2013
U-173
U-251
U-301
U-317
TROSPIUM CHLORIDE - SANCTURA XR
N 022103 001 7410978
7759359
7763635
7781448
7781449
Feb 01, 2025
Nov 04, 2024
Nov 04, 2024
Nov 04, 2024
Nov 04, 2024
DP
U-1071
U-1071
U-1071
U-1071
TROVAFLOXACIN MESYLATE - TROVAN
N 020759 001 5763454
6187341
Jun 15, 2015
Jan 20, 2019
U-282
TROVAFLOXACIN MESYLATE - TROVAN
N 020759 002 5763454
6187341
Jun 15, 2015
Jan 20, 2019
U-282
TRYPAN BLUE - MEMBRANEBLUE
N 022278 001 ODE Feb 20, 2016
ULIPRISTAL ACETATE - ELLA
N 022474 001 8426392
8512745
Jun 12, 2030
Feb 14, 2030
U-1389
DP
NCE Aug 13, 2015
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - ANORO ELLIPTA
N 203975 001 5873360 Feb 23, 2016 DP
7361787 Mar 23, 2023 DS DP U-1476
7439393 Sep 11, 2022 DS DP U-1476
7488827 Apr 27, 2025 DS DP
7498440 Apr 27, 2025 DS DP
7776895 Sep 11, 2022 DP
8113199 Oct 23, 2027 DP
8161968 Feb 05, 2028 DP
8183257 Jul 27, 2025 U-1476
8309572 Apr 27, 2025 U-1476
8511304 Nov 11, 2025 DP U-1476
8534281 Aug 10, 2029 DP
UNOPROSTONE ISOPROPYL - RESCULA
N 021214 001 6458836
6458836
6770675
Jul 09, 2021
Jul 09, 2021
Nov 24, 2018
U-333
U-1315
DP U-1322
UROFOLLITROPIN - FERTINEX
N 019415 004 5767067 Jun 16, 2015
UROFOLLITROPIN - FERTINEX
N 019415 005 5767067 Jun 16, 2015
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 210 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
VALACYCLOVIR HYDROCHLORIDE - VALTREX
N 020487 001 5879706
5879706
6107302
6107302
Jan 19, 2016
Jan 19, 2016
Jan 19, 2016
Jan 19, 2016
DP U-530
DP U-894
DS U-530
DS U-894
VALACYCLOVIR HYDROCHLORIDE - VALTREX
N 020487 002 5879706
5879706
6107302
6107302
Jan 19, 2016
Jan 19, 2016
Jan 19, 2016
Jan 19, 2016
DP U-530
DP U-894
DS U-530
DS U-894
VALDECOXIB - BEXTRA
N 021341 002 5633272 Feb 13, 2015 U-462
VALDECOXIB - BEXTRA
N 021341 003 5633272 Feb 13, 2015 U-462
VALGANCICLOVIR HYDROCHLORIDE - VALCYTE
N 021304 001 6083953
6083953
Mar 29, 2015
Mar 29, 2015
DS DP U-384
DS DP U-854
D-125 Aug 05, 2013
VALGANCICLOVIR HYDROCHLORIDE - VALCYTE
N 022257 001 6083953
6083953
Mar 29, 2015
Mar 29, 2015
DS DP U-384
DS DP U-854
VALSARTAN - DIOVAN
N 021283 001 5972990
6294197
Oct 26, 2016
Jun 18, 2017
U-692
U-3
VALSARTAN - DIOVAN
N 021283 002 5972990
6294197
Oct 26, 2016
Jun 18, 2017
U-692
U-3
VALSARTAN - DIOVAN
N 021283 003 5972990
6294197
Oct 26, 2016
Jun 18, 2017
U-692
U-3
VALSARTAN - DIOVAN
N 021283 004 5972990
6294197
Oct 26, 2016
Jun 18, 2017
U-692
U-3
VANDETANIB - CAPRELSA
N 022405 001 7173038
8067427
RE42353
VANDETANIB - CAPRELSA
Aug 14, 2021
Aug 08, 2028
Sep 23, 2017
DS DP
DP
DS DP
NCE
ODE
Apr 06, 2016
Apr 06, 2018
N 022405 002 7173038 Aug 14, 2021
8067427 Aug 08, 2028
RE42353 Sep 23, 2017
VARDENAFIL HYDROCHLORIDE - LEVITRA
DS DP
DP
DS DP
NCE
ODE
Apr 06, 2016
Apr 06, 2018
N 021400 001 6362178
7696206
8273876
Oct 31, 2018
Oct 31, 2018
Jul 23, 2027
DS DP U-533
DS DP U-533
U-1288
VARDENAFIL HYDROCHLORIDE - LEVITRA
N 021400 002 6362178
7696206
8273876
Oct 31, 2018
Oct 31, 2018
Jul 23, 2027
DS DP U-533
DS DP U-533
U-1288
VARDENAFIL HYDROCHLORIDE - LEVITRA
N 021400 003 6362178
7696206
8273876
Oct 31, 2018
Oct 31, 2018
Jul 23, 2027
DS DP U-533
DS DP U-533
U-1288
VARDENAFIL HYDROCHLORIDE - LEVITRA
N 021400 004 6362178
7696206
8273876
Oct 31, 2018
Oct 31, 2018
Jul 23, 2027
DS DP U-533
DS DP U-533
U-1288
VARDENAFIL HYDROCHLORIDE - STAXYN
N 200179 001 6362178
7696206
Oct 31, 2018
Oct 31, 2018
U-155
U-155
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 211 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
VARENICLINE TARTRATE - CHANTIX
N 021928 001 6410550 May 10, 2020 DS DP U-56 M-105 Jul 22, 2014
6890927 May 06, 2022 DS DP U-56
7265119 Aug 03, 2022 DS DP U-56
VARENICLINE TARTRATE - CHANTIX
N 021928 002 6410550 May 10, 2020 DS DP U-56 M-105 Jul 22, 2014
6890927 May 06, 2022 DS DP U-56
7265119 Aug 03, 2022 DS DP U-56
VELAGLUCERASE ALFA - VPRIV
N 022575 001 M-130 Nov 21, 2016
NCE Feb 26, 2015
VELAGLUCERASE ALFA - VPRIV
N 022575 002 M-130 Nov 21, 2016
NCE Feb 26, 2015
VEMURAFENIB - ZELBORAF
N 202429 001 7504509 Oct 22, 2026 DS DP NCE Aug 17, 2016
7863288 Jun 20, 2029 DS DP ODE Aug 17, 2018
8143271 Jun 21, 2026 DS DP
8470818 Aug 02, 2026 U-1418
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N 020699 001 6274171 Mar 20, 2017
6403120 Mar 20, 2017 U-451
6403120 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958 Mar 20, 2017 U-535
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N 020699 002 6274171 Mar 20, 2017
6403120 Mar 20, 2017 U-451
6403120 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958 Mar 20, 2017 U-535
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N 020699 003 6274171 Mar 20, 2017
6403120 Mar 20, 2017 U-451
6403120 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958 Mar 20, 2017 U-535
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N 020699 004 6274171 Mar 20, 2017
6403120 Mar 20, 2017 U-451
6403120 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958 Mar 20, 2017 U-535
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 212 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N 022104 001 6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-839
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N 022104 002 6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-839
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N 022104 003 6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-839
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N 022104 004 6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-839
VERAPAMIL HYDROCHLORIDE - COVERA-HS
N 020552 001 6096339 Apr 04, 2017 U-365
VERAPAMIL HYDROCHLORIDE - COVERA-HS
N 020552 002 6096339 Apr 04, 2017 U-365
VERTEPORFIN - VISUDYNE
N 021119 001 5707608 Aug 02, 2015
5756541 Mar 11, 2016 U-357
5770619 Jan 06, 2015 U-357
5798349 Aug 25, 2015 U-357
VIGABATRIN - SABRIL
N 020427 001 NCE Aug 21, 2014
NPP Oct 26, 2016
PED Feb 21, 2015
PED Apr 26, 2017
VIGABATRIN - SABRIL
N 022006 001 NCE Aug 21, 2014
NPP Oct 26, 2016
ODE Aug 21, 2016
PED Feb 21, 2017
PED Apr 26, 2017
PED Feb 21, 2015
VILAZODONE HYDROCHLORIDE - VIIBRYD
N 022567 001 5532241 Sep 29, 2014 DS DP NCE Jan 21, 2016
7834020 Jun 05, 2022 DS DP U-839
8193195 Jun 05, 2022 U-839
8236804 Jun 05, 2022 U-839
VILAZODONE HYDROCHLORIDE - VIIBRYD
N 022567 002 5532241 Sep 29, 2014 DS DP NCE Jan 21, 2016
7834020 Jun 05, 2022 DS DP U-839
8193195 Jun 05, 2022 U-839
8236804 Jun 05, 2022 U-839
VILAZODONE HYDROCHLORIDE - VIIBRYD
N 022567 003 5532241 Sep 29, 2014 DS DP NCE Jan 21, 2016
7834020 Jun 05, 2022 DS DP U-839
8193195 Jun 05, 2022 U-839
8236804 Jun 05, 2022 U-839
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 213 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
VINCRISTINE SULFATE - MARQIBO KIT
N 202497 001 5543152 Jun 20, 2014
5741516 Jun 20, 2014
5814335 Jun 20, 2014
6723338 Mar 31, 2020
7247316 Sep 25, 2020
7887836 Mar 31, 2020
DP
DP
DP
U-1271
DP
U-1271
NP
ODE
Aug 09, 2015
Aug 09, 2019
VISMODEGIB - ERIVEDGE
N 203388 001 7888364 Nov 11, 2028 DS DP NCE Jan 30, 2017
VORICONAZOLE - VORICONAZOLE
A 202361 001 PC Mar 24, 2014
VORICONAZOLE - VFEND
N 021266 001 5567817
VORICONAZOLE - VFEND
May 24, 2016 DS DP U-540
N 021266 002 5567817
VORICONAZOLE - VFEND
May 24, 2016 DS DP U-540
N 021267 001 5567817
6632803
May 24, 2016
Jun 02, 2018
DS DP U-540
DP
VORICONAZOLE - VFEND
N 021630 001 5567817
VORINOSTAT - ZOLINZA
May 24, 2016 DS DP U-540
N 021991 001 7399787
7456219
7652069
7732490
7851509
8067472
8093295
8101663
RE38506
Feb 09, 2025
Mar 11, 2027
Mar 04, 2023
Mar 04, 2023
Feb 21, 2024
Mar 04, 2023
May 16, 2026
Mar 04, 2023
Jul 07, 2015
U-892
DS
DP
U-892
DP U-892
U-892
DP
U-892
DS DP
ODE Oct 06, 2013
VORTIOXETINE HYDROBROMIDE - BRINTELLIX
N 204447 001 7144884
8476279
Jan 09, 2023
Oct 02, 2022
DS DP U-1439
DP U-1439
NCE Sep 30, 2018
VORTIOXETINE HYDROBROMIDE - BRINTELLIX
N 204447 002 7144884
8476279
Jan 09, 2023
Oct 02, 2022
DS DP U-1439
DP U-1439
NCE Sep 30, 2018
VORTIOXETINE HYDROBROMIDE - BRINTELLIX
N 204447 003 7144884
8476279
Jan 09, 2023
Oct 02, 2022
DS DP U-1439
DP U-1439
NCE Sep 30, 2018
VORTIOXETINE HYDROBROMIDE - BRINTELLIX
N 204447 004 7144884
8476279
Jan 09, 2023
Oct 02, 2022
DS DP U-1439
DP U-1439
NCE Sep 30, 2018
ZAFIRLUKAST - ACCOLATE
N 020547 001 5612367 Mar 18, 2014 U-189
ZAFIRLUKAST - ACCOLATE
N 020547 003 5612367 Mar 18, 2014 U-189
ZANAMIVIR - RELENZA
N 021036 001 5360817
5648379
5648379
5648379
6294572
Jul 26, 2013
Jul 15, 2014
Jul 15, 2014
Jul 15, 2014
Dec 15, 2014
DS DP
U-274
U-721
U-722
DS DP
ZICONOTIDE - PRIALT
N 021060 003 5364842
5364842
5795864
Dec 30, 2016
Dec 30, 2016
Jun 27, 2015
U-48
U-55
DP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 214 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ZICONOTIDE ACETATE - PRIALT
N 021060 001 5364842 Dec 30, 2016 U-48
5364842 Dec 30, 2016 U-55
5795864 Jun 27, 2015 DP
ZICONOTIDE ACETATE - PRIALT
N 021060 002 5364842 Dec 30, 2016 U-48
5364842 Dec 30, 2016 U-55
5795864 Jun 27, 2015 DP
ZICONOTIDE ACETATE - PRIALT
N 021060 004 5364842 Dec 30, 2016 U-48
5364842 Dec 30, 2016 U-55
5795864 Jun 27, 2015 DP
ZILEUTON - ZYFLO CR
N 022052 001 6183778 Sep 21, 2013 DP
ZIPRASIDONE HYDROCHLORIDE - GEODON
N 020825 001 6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N 020825 002 6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N 020825 003 6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N 020825 004 6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N 021483 001 6150366 May 27, 2019 DP U-719
6245766 Dec 18, 2018 U-601
7175855 May 18, 2020 DP
ZIPRASIDONE MESYLATE - GEODON
N 020919 001 6110918 Mar 26, 2017
6232304 Apr 01, 2017
6399777 Apr 01, 2017
ZOLEDRONIC ACID - ZOMETA
N 021223 002 8324189 May 29, 2025 U-53
8324189 May 29, 2025 U-1308
8324189 May 29, 2025 U-1309
ZOLEDRONIC ACID - ZOMETA
N 021223 003 7932241 Feb 05, 2028 DP
8324189 May 29, 2025 U-53
8324189 May 29, 2025 U-1308
8324189 May 29, 2025 U-1309
ZOLEDRONIC ACID - RECLAST
N 021817 001 7932241 Feb 05, 2028 DP
8052987 Oct 27, 2023 U-1199
ZOLMITRIPTAN - ZOMIG
N 021450 004 6750237 Nov 28, 2020 DP
7220767 Nov 28, 2020 DP
ZOLPIDEM TARTRATE - AMBIEN CR
N 021774 001 6514531 Dec 01, 2019 DP
ZOLPIDEM TARTRATE - AMBIEN CR
N 021774 002 6514531 Dec 01, 2019 DP
ZOLPIDEM TARTRATE - EDLUAR
N 021997 001 6761910 Sep 24, 2019 DP U-674
8512747 Sep 24, 2019 U-674
ZOLPIDEM TARTRATE - EDLUAR
N 021997 002 6761910 Sep 24, 2019 DP U-674
8512747 Sep 24, 2019 U-674
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
ADA 215 of 215
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
NO PATENT NO
ZOLPIDEM TARTRATE - ZOLPIMIST
N 022196 001 7632517
ZOLPIDEM TARTRATE - INTERMEZZO
N 022328 001 7658945
7682628
8242131
8252809
ZOLPIDEM TARTRATE - INTERMEZZO
N 022328 002 7658945
7682628
8242131
8252809
PATENT
EXPIRATION
DATE
PATENT
CODES
PATENT
DELIST
REQUESTED
EXCLUSIVITY
CODE(S)
EXCLUSIVITY
EXPIRATION
DATE
Oct 01, 2017 U-70
Apr 15, 2027
Feb 16, 2025
Aug 20, 2029
Feb 16, 2025
DP U-1194
U-1194
U-1266
DP
NP Nov 23, 2014
Apr 15, 2027
Feb 16, 2025
Aug 20, 2029
Feb 16, 2025
DP U-1194
U-1194
U-1266
DP
NP Nov 23, 2014
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 1 of 62
PATENT & EXCLUSIVITY ABBREVIATIONS
D
I
M
NC
NEW DOSING SCHEDULE (SEE INDIVIDUAL REFERENCES)
NEW INDICATION (SEE INDIVIDUAL REFERENCES)
MISCELLANEOUS EXCLUSIVITY CODES (SEE INDIVIDUAL REFERENCES)
NEW COMBINATION
NCE NEW CHEMICAL ENTITY
NCE*
NDF
NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE
SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT).
NEW DOSAGE FORM
NE NEW ESTER OR SALT OF AN ACTIVE INGREDIENT
NP NEW PRODUCT
NP*
NPP
NEW PRODUCT (MINT FLAVORED)
NEW PATIENT POPULATION
NR NEW ROUTE
NS NEW STRENGTH
ODE ORPHAN DRUG EXCLUSIVITY
PC PATENT CHALLENGE
PED PEDIATRIC EXCLUSIVITY
RTO RX TO OTC SWITCH OR OTC USE
RTO* OTC USE FOR WOMEN AGES 15 AND 16
RTO** OTC USE FOR WOMEN 14 AND BELOW
U PATENT USE CODE
W EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR
- SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
EXCLUSI VI TY DOSI NG SCHEDULE
D-1 ONCE A DAY APPLICATION
D-2 ONCE DAILY DOSING
D-3
D-4
D-5
D-6
D-7
SEVEN DAYS/SEVEN DAYS/SEVEN DAYS DOSING SCHEDULE
SEVEN DAYS/FOURTEEN DAYS DOSING SCHEDULE
TEN DAYS/ELEVEN DAYS DOSING SCHEDULE
SEVEN DAYS/NINE DAYS/FIVE DAYS DOSING SCHEDULE
BID DOSING
D-8
D-9
INTRAVENOUS, EPIDURAL AND INTRATHECAL DOSING
NARCOTIC OVERDOSE IN ADULTS
D-10 NARCOTIC OVERDOSE IN CHILDREN
D-11 POSTOPERATIVE NARCOTIC DEPRESSION IN CHILDREN
D-12 BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE DUODENAL ULCER
D-13 INCREASED MAXIMUM DAILY DOSAGE RECOMMENDATION
D-14 BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
D-15
D-16
SINGLE DAILY DOSE OF 25MG/37.5MG
CONTINUOUS INTRAVENOUS INFUSION
D-17 400MG EVERY 12 HOURS FOR THREE DAYS FOR UNCOMPLICATED URINARY TRACT INFECTIONS
D-18 LOWER RECOMMENDED STARTING DOSE GUIDELINES
D-19 BOLUS DOSING GUIDELINES
D-20 SINGLE 32MG DOSE
D-21 ALTERNATIVE DOSAGE OF 300MG ONCE DAILY AFTER THE EVENING MEAL
D-22 REDUCTION IN INFUSION TIME FROM 24 TO 4 HOURS FOR THE 60MG DOSE
D-23 INCREASE MAXIMUM DOSE AND VARIATIONS IN THE DOSING REGIMEN
D-24 FOR OVARIAN CANCER THE RECOMMENDED REGIMEN IS 135MG/M2 OR 175MG/M2 INTRAVENOUSLY
OVER THREE HOURS EVERY THREE WEEKS
D-25
D-26
ADDITIONAL DOSAGE REGIMEN EQUAL TO HALF THE ORIGINAL DOSING REGIMEN
ONCE WEEKLY APPLICATION
D-27 BID DOSING IN PATIENTS 12 YEARS OF AGE AND OLDER FOR PREVENTION OF NAUSEA AND
VOMITING ASSOCIATED WITH MODERATE EMETOGENIC CANCER CHEMOTHERAPY
D-28 USE OF ISOVUE-370 IN EXCRETORY UROGRAPHY AT EQUIVALENT GRAMS OF IODINE TO THE
CURRENTLY APPROVED ISOVUE-250 AND ISOVUE-300
D-29
D-30
INCREASE OF CUMULATIVE DOSE TO 0.3MMOL/KG FOR MRI OF CNS IN ADULTS
5000 IU DOSE FOR PHOPHYLAXIX AGAINST DEEP VEIN THROMBOSIS
D-31
D-32
CHANGE IN RECOMMENDED TOTAL DAILY DOSE TO 80MG (40MG BID)
REMOVAL OF THE RESTRICTIONS LIMITING TREATMENT TO TWO CONSECUTIVE WEEKS AND TO
SMALL AREAS
D-33 ONCE DAILY DOSING FOR PLAQUE PSORIASIS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 2 of 62
EXCLUSI VI TY DOSI NG SCHEDULE
D-34 EVERY FOUR MONTHS DOSAGE REGIMEN
D-35 FOR A ONE WEEK DOSING OF INTERDIGITAL TINEA PEDIS
D-36 FOR A SINGLE 2MG DOSE AS AN ALTERNATIVE TO THE 1MG DOSE GIVEN TWICE DAILY
D-37
D-38
DOSING REGIMEN FOR ADMINISTRATION EITHER ONCE DAILY (QD) OR TWICE DAILY (BID)
CONTINUOUS INFUSION AS AN ALTERNATE METHOD OF ADMINISTRATION
D-39 CHANGE IN TIME TO TAKE THE DRUG PRIOR TO A MEAL TO PREVENT MEAL-INDUCED HEARTBURN
SYMPTOMS FROM "..1/2 TO 1 HOUR BEFORE EATING" TO ".. RIGHT BEFORE EATING OR UP TO
60MIN BEFORE CONSUMING..."
D-40 ONCE-A-DAY DOSING REGIMEN
D-41 DRUG MAY BE DOSED RIGHT BEFORE A MEAL OR ANY TIME UP TO 30MIN BEFORE EATING OR
DRINKING FOOD AND BEVERAGES THAT WOULD BE EXPECTED TO CAUSE SYMPTOMS
D-42 TEN DAY DOSING REGIMEN FOR TRIPLE THERAPY, PREVACID IN COMBINATION WITH
CLARITHROMYCIN AND AMOXICILLIN, FOR THE ERADICATION OF H.PYLORI IN PATIENTS WITH
DUODENAL ULCER DISEASE
D-43
D-44
INITIATION OF TREATMENT WITH 900MG/DAY BY DELETION OF THE REQUIREMENT TO TITRATE
TO 900MG/DAY OVER A 3-DAY PERIOD
IN A CLINICAL TRIAL, FEWER DISCONTINUATIONS DUE TO ADVERSE EVENTS, ESPECIALLY
DIZZINESS AND VERTIGO, WERE OBSERVED WHEN TITRATING THE DOSE IN INCREMENTS OF
50MG/DAY EVERY 3 DAYS UNTIL AN EFFECTIVE DOSE (NOT EXCEEDING 400MG/DAY) WAS
REACHED
D-45 ONCE DAILY DOSING FOR MAINTENANCE ONLY
D-46 NEW DOSING REGIMEN OF 80MG DAILY
D-47
D-48
PREVENTION OF HEARTBURN SYMPTOMS WHEN ADMINISTERED FROM 15 MINUTES UP TO, BUT NOT
INCLUDING, 1 HOUR PRIOR TO A PROVOCATIVE MEAL
ADIMISTRATION OF CISATRICURIUM A NEUROMUSCULAR BLOCKING AGENT AT DOSES OF 3 AND 4X
THE ED95 OF CISATRICURIUM FOLLOWING INDUCTION WITH THIOPENTAL
D-49 PEDIATRIC DOSING GUIDELINES
D-50 INFORMATION FOR USE OF CORVERT IN POST-CARDIAC SURGERY PATIENTS
D-51
D-52
OPTIONAL STARTING DOSE OF 40MG/DAY
ALTERNATE DOSING REGIMEN OF 1250MG TWICE DAILY
D-53 USE IN PEDIATRIC PATIENTS FROM 1 MONTH TO 16 YEARS OF AGE
D-54 USE OF ZYBAN FOR MAINTENANCE THERAPY. TREATMENT UP TO 6 MONTHS WAS SHOWN
EFFICACIOUS
D-55
D-56
ADDITION OF A HIGHER DOSE OF NUTROPIN FOR PUBERTAL PATIENTS (PUBERTAL DOSE LESS
THAN OR EQUAL TO 0.7MG/KG/WEEK)
ADDITION OF POSTPRANDIAL DOSING
D-57 3-HOUR INFUSION OF TAXOL GIVEN EVERY THREE WEEKS AT A DOSE OF 175MG/M2 FOLLOWED BY
CISPLATIN AT A DOSE OF 75MG/M2 FOR THE FIRST-LINE TREATMENT OF ADVANCED OVARIAN
CANCER
D-58 CHANGE IN DOSING INTERVAL TO ONCE-DAILY ADMINISTRATION
D-59 REDUCTION OF ELEVATED LDL-C IN A NEW, HIGHER STRENGTH TABLET, 0.8MG, AND FOR
EXTENSION OF THE DOSAGE RANGE TO 0.8MG DAILY
D-60 ADDITION OF A POST-OPERATIVE DOSING REGIMEN
D-61 ONCE WEEKLY DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
D-62 ONCE WEEKLY DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
D-63 TO ALLOW A TITRATION DOSING REGIMEN USING A 25MG DOSE
D-64 INCREASING DOSAGE FOR NERVE BLOCK ANESTHESIA USING NAROPIN 7.5MG/ML AND FOR
EXTENDING THE DURATION OF TREATMENT FOR POSTOPERATIVE ANALGESIA USING NAROPIN
D-65
2MG/ML
CHANGE DOSING AND ADMINISTRATION TO INDICATE MAINTENANCE OF WEIGHT LOSS OVER AN 18
MONTH PERIOD THUS EXTENDING THE USE OF THIS DRUG FROM ONE TO TWO YEARS
D-66 DOSING RECOMMENDATIONS FOR PATIENTS UNDERGOING PCI
D-67 SHORTER TREATMENT COURSE OF THREE DAYS IN THE TREATMENT OF RECURRENT EPISODES OF
GENITAL HERPES
D-68 CHANGE OF ADMIN RATE FOR INFUSION OF AREDIA FOR TREATMENT OF MODERATE AND SEVERE
HYPERCALCEMIA OF MALIGNANCY FROM 24 HOURS TO 2 HOURS UP TO BUT NOT INCLUDING 24
HOURS
D-69 SHORTENED DOSING REGIMEN TO 5 DAYS FOR THE TREATMENT OF ACUTE EXACERBATION OF
CHRONIC BRONCHITIS
D-70 80MG ONCE DAILY DOSING REGIMEN
D-71 EIGHT WEEK DOSING REGIMEN
D-72 INFORMATION REGARDING INCREASED RATE OF INFUSION FOR DEPACON
D-73 ONCE A WEEK DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
D-74 ONCE A WEEK DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
D-75 INTERMITTENT DOSING REGIMEN, STARTING DAILY DOSE 14 DAYS PRIOR TO THE ANTICIPATED
ONSET OF MENSTRUATION THROUGH THE FIRST FULL DAY OF MENSES AND REPEATING WITH EACH
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 3 of 62
EXCLUSI VI TY DOSI NG SCHEDULE
NEW CYCLE
D-76 FOR USE ON AN "AS NEEDED" OR PRN BASIS FOR THE MANAGEMENT OF NASAL SYMPTOMS IN
PATIENTS FOR WHOM THE DRUG IS INDICATED
D-77 ADDITION OF 20MG AND 40MG DAILY AS OPTIONAL STARTING DOSES WITH 40MG INTENDED FOR
D-78
PATIENTS WHO REQUIRE A LARGE REDUCTION IN LDL-C (MORE THAN 45%)
USE OF FLEXERIL 5MG FOR THE RELIEF OF MUSCLE SPASM ASSOCIATED WITH ACUTE, PAINFUL,
MUSCULOSKELETAL CONDITIONS
D-79 NEW LOWER STARTING DOSE FOR TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS
AND/OR MODERATE TO SEVERE SYMPTOMS OF VULVAR AND VAGINAL ATROPHY ASSOCIATED W/ THE
MENOPAUSE
D-80 CHANGE OF DOSING SCHEDULE FOR LANTUS FROM ONCE DAILY AT BEDTIME TO FLEXIBLE DAILY
DOSING
D-81 NEW LOWER STARTING DOSE FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPORSIS
D-82 USE OF PREMARIN 0.3 MG AND 0.45 MG FOR THE PREVENTION OF POSTMENOPAUSAL
OSTEOPOROSIS
D-83
D-84
750 MG, ONCE DAILY FOR 5 DAYS FOR COMMUNITY ACQUIRED PNEUMONIA (CAP)
ONCE-A-DAY DOSING OF FLOXACIN OTIC FOR THE TREATMENT OF ADULTS AND PEDIATRIC
D-85
PATIENTS(AGES 6 MO & OLDER) W/ OTITIS EXTERNA CAUSED BY SUSCEPTIBLE STRAINS OF
E.COLI, P.AERUGINOSA AND S.AUREUS
LOWER RECOMMENDED STARTING DOSE GUIDELINES FOR TREATMENT OF MODERATE TO SEVERE
VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE
D-86 FOR USE IN SELECT EXTERNAL INSULIN PUMPS
D-87 ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH
OSTEOPOROSIS
D-88 NEW DOSING RANGE OF 200-400MG PER DAY IN TWO DIVIDED DOSES FOR ADULTS WITH PARTIAL
SEIZURES
D-89 USE OF REYATAZ 300 MG/RITONAVIR 100 MG ONCE DAILY FOR TREATMENT IN HIV-INFECTED
ANTIRETROVIRAL-EXPERIENCED PATIENTS
D-90 ADDITION OF DAYTIME ADMINISTRATION TO TREAT VULVOVAGINAL CANDIDIASIS
D-91 ALTERNATE INTERMITTENT DOSING REGIMEN
D-92 ALTERNATIVE DOSAGE OF 1000MG ONCE DAILY AT BEDTIME
D-93 ALTERNATE TWO OR THREE TIMES DAILY DOSING REGIMENS
D-94
D-95
NEW MAXIMUM DOSAGE OF 72 MG/DAY IN ADOLESCENTS 13-17 YEARS OF AGE WITH ATTENTION
DEFECIT HYPERACTIVITY DISORDER (ADHD)
BROADENED INITIAL STARTING DOSE FOR HYPERTENSION FROM 50 MG TO 100 MG TO 25 MG TO
100 MG DOSE RANGE
D-96
D-97
ONCE-MONTHLY TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS WITH BONIVA (IBANDRONATE
SODIUM) 150 MG TABLETS
PED CANCER PT POPULATION EXPANDED TO INCLUDE PTS 6 MOS UP TO BUT NOT INCLUDING 4
YRS AND DOSING INSTRUCTIONS TO ADMIN 30 MIN BEFPRE CHEMO WITH SECOND AND THIRD
DOSES 4 & 8 HOURS AFTER FIRST DOSE
D-98 DOSING FOR PED SURGICAL PTS EXPANDED TO INCLUDE PTS 1 MONTH UP TO BUT NOT
INCLUDING 2 YEARS OF AGE
D-99 ONCE DAILY ADMINISTRATION FOR THE TREATMENT OF HIV INFECTION IN THERAPY NAIVE
ADULT PATIENTS
D-100 750 MG ONCE DAILY FOR FIVE DAYS FOR THE TREATMENT OF ACUTE BACTERIAL SINUSITIS
D-101 ONCE DAILY IN CHRONIC IDIOPATHIC UTICARIA FOR ADULTS AND CHILDREN 12 YEARS OF AGE
AND OLDER
D-102 NEW DOSING REGIMEN OF ONE SPRAY TWICE DAILY FOR SEASONAL ALLERIC RHINITIS IN
PATIENTS 12 YRS OF AGE AND OLDER
D-103 NEW DOSING RECOMMENDATION FOR THE TREATMENT OF RECURRENT GENITAL HERPES IN
IMMUNOCOMPETENT PATIENTS, SPECIFICALLY A REDUCTION IN COURSE OF THERAPY FROM
FAMCICLOVIR 125 MG TWICE-A-DAY FOR 5 DAYS TO 1000 MG TWICE-A-DAY FOR 1 DAY.
D-104 0.5MG/0.1MG FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED
WITH MENOPAUSE IN WOMEN WHO HAVE A UTERUS
D-105 USE OF ACTONEL 75MG TWO CONSECUTIVE DAYS PER MONTH FOR THE PREVENTION AND
TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
D-106
D-107
FIVE DAY TREATMENT OF SELECTED SUSCEPTIBLE STRAINS OF STREPTOCOCCUS PNEUMONIAE,
HAEMOPHILUS INFLUENZA, MYCOPLASMA PNEUMONIAE, AND CHLAMYDIA PNEUMONIAE FOR
COMMUNITY-ACQUIRED PNEUMONIA
PROVIDES FOR THE COMBINATION TABLET OF 70MG ALENDRONATE AND 5600 IU OF VITAMIN D3
FOR THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND TO INCREASE BONE
MASS IN MEN WITH OSTEOPOROSIS
D-108 TREATMENT OF COMPLICATED URINARY TRACT INFECTION AND ACUTE PYELONEPHRITIS WITH
D-109
LEVAQUIN 750MG ONCE DAILY FOR FIVE DAYS
PROVIDE FOR THE USE OF A LOWER DOSE FOR THE TREATMENT OF ADULTS WITH CHRONIC PHASE
CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY
INCLUDING IMATINIB MESYLATE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 4 of 62
EXCLUSI VI TY DOSI NG SCHEDULE
D-110 TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGED 13-17
D-111 PROVIDES FOR ONCE DAILY USE OF CIALIS, 2.5 MG AND 5 MG, FOR THE TREAMTENT OF
ERECTILE DYSFUNCTION
D-112 PROVIDES FOR PEDIATRIC PUMP USE
D-113 ONCE DAILY DOSING REGIMEN FOR PATIENTS WHO BECOME CONSTIPATED ON TWICE DAILY
REGIMEN
D-114 NEW DOSING RECOMMENDATIONS FOR USE OF SIROLIMUS IN COMBINATION WITH CYCLOSPORINE
FOR THE PROPHYLAXIS OF REJECTION IN HIGH-RISK RENAL TRANSPLANT RECIPIENTS
D-115 STARTING DOSE OF 15MG/DAY FOR MONOTHERAPY IN ACUTE TREATMENT OF BIPOLAR DISORDER,
MANIC OR MIXED
D-116 ALTERNATIVE DOSING REGIMEN ATAZANAVIR SULATE CO-ADMINISTERED WITH RITONAVIR FOR
THE TREATMENT OF HIV-1 INFECTION IN TREATMENT NAIVE PATIENTS
D-117 50 MG TABLET FOR INITIATION OF DOSE TITRATION FOR BIPOLAR DISORDER
D-118
D-119
TWO 400MG TABLETS ONCE DAILY, CO-ADMINISTERED WITH 100MG RITONAVIR
DOSING RECOMMENDATIONS FOR HIV INFECTED PEDIATRIC PATIENTS 6 TO LESS THAN 18 YEARS
OF AGE
D-120 DOSING REGIMEN ADJUSTMENTS
D-121 CHANGE TO REMOVE 20 MG MAXIMUM DOSAGE RESTRICTION
D-122 USE OF VAGIFEM 10 MCG FOR THE TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
D-123 ALTERNATIVE DOSING REGIMEN DOSE OF 20 MG/METER SQUARE BY CONTINUOUS INTRAVENOUS
INFUSION OVER 1 HOUR REPEATED DAILY FOR 5 DAYS
D-124 ONCE DAILY DOSING REGIMEN IN ADULT PATIENTS WITH LESS THAN THREE LOPINAVIR
RESISTANCE-ASSOCIATED SUBSTITUTIONS
D-125 EXTEND CURRENT DOSING REGIMEN TO 900MG (2-450MG TABLETS) ONCE A DAY WITHIN 10 DAYS
OF TRANSPLANTATION UNTIL 200 DAYS POST-TRANSPLANTATION FOR THE PREVENTION OF
D-126
CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT PATIENTS AT HIGH RISK.
CHANGE DOSAGE REGIMEN FROM 250MG TO 500MG
D-127 DOSING REGIMEN FOR ADULT PATIENTS WITH CHRONIC HEPATITIS B (CHB) AND DECOMPENSATED
LIVER DESEASE
D-128 SINGLE IV DOSE OF FOSAPREPITANT 150MG, DOSED CONCOMITANTLY WITH 5HT3 RECEPTOR
ANTAGONIST & CORTICOSTEROID, FOR PREVENTION OF ACUTE & DELAYED NAUSEA & VOMITING
ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMO
D-129 800/100 MG DARUNAVIR/RITONAVIR, ONCE DAILY, IN TREATMENT -EXPERIENCED HIV-1
INFECTED PATIENTS WITH NO DARUNIVIR RESISTANCE ASSOCIATED SUBSITUTIONS
D-130 DOSING RECOMMENDATIONS FOR TREATMENT OF HIV-1 INFECTION DURING PREGNANCY BASED ON
D-131
DATA FROM STUDY AI424-182, A STUDY OF ATAZANAVIR/RITONAVIR IN COMBINATION WITH
ZIDOVUDINE/LAMIVUDINE IN HIV INFECTED PREGNANT WOMEN
EVERY 6 TO 8 WEEKS FOR THE 120MG STRENGTH FOR PATIENTS WHO ARE CONTROLLED ON
SOMATULINE DEPOT 60MG OR 90MG
D-132 45MG FOR 6 MONTH ADMINISTRATION
D-133 NEW EFFICACY DATA AND DOSING REGIMEN FOR PREGNANCY IN NORMAL OVULATORY WOMEN
UNDERGOING CONTROLLED OVARIAN STIMULATION AS PART OF AN IVF OR INTRACYTOPLASMIC
D-134
D-135
SPERM INJECTION (ICSI) CYCLE
INCREASING MAXIMUM DOSING OF PATIENTS WITH SCHIZOPHRENIA TO 160 MG/DAY
UPDATE LABELING WITH ONCE DAILY DOSING IN HIV-1 INFECTED, TREATMENT-NAIVE
PEDIATRIC PATIENTS 12 TO LESS THAN 18 YEARS OF AGE
D-136 ALTERNATE DOSING REGIMEN FOR UNCOMPLICATED URETHRAL OR ENDOCERVICAL INFECTION
CAUSED BY CHLAMYDIA TRACHOMATIS, ADMINISTER 200 MG BY MOUTH ONCE-A-DAY FOR 7 DAYS
EXCLUSI VI TY I NDI CATI ON
I-1 DYSMENORRHEA
I-2 CHOLANGIOPANCREATOGRAPHY
I-3 INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
I-4
I-5
PERIPHERAL VENOGRAPHY (PHLEBOGRAPHY)
HYSTEROSALPINGOGRAPHY
I-6 TREATMENT OF JUVENILE ARTHRITIS
I-7 BIOPSY PROVEN MINIMAL CHANGE NEPHROTIC SYNDROME IN CHILDREN
I-8 ADULT INTRAVENOUS CONTRAST-ENHANCED COMPUTED TOMOGRAPHY OF THE HEAD AND BODY
I-9 PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
I-10 PREVENTION OF POSTOPERATIVE DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM IN TOTAL
HIP REPLACEMENT SURGERY
I-11 RELIEF OF MILD TO MODERATE PAIN
I-12 TREATMENT OF CUTANEOUS CANDIDIASIS
I-13 URINARY TRACT INFECTION (UTI) PREVENTION FOR PERIODS UP TO FIVE MONTHS IN WOMEN
WITH A HISTORY OF RECURRENT UTI
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 5 of 62
EXCLUSI VI TY I NDI CATI ON
I-14 SEBORRHEIC DERMATITIS
I-15 PHOTOPHERESIS IN THE PALLIATIVE TREATMENT OF SKIN MANIFESTATIONS OF CUTANEOUS T-
CELL LYMPHOMA IN PERSONS NOT RESPONSIVE TO OTHER TREATMENT
I-16 STIMULATE THE DEVELOPMENT OF MULTIPLE FOLLICLES/OOCYTES IN OVULATORY PATIENTS
PARTICIPATING IN AN IN VITRO FERTILIZATION PROGRAM
I-17 MANAGEMENT OF CONGESTIVE HEART FAILURE
I-18 ENDOSCOPIC RETROGRADE PANCREATOGRAPHY
I-19 HERNIOGRAPHY
I-20 KNEE ARTHROGRAPHY
I-21 HIGH DOSE METHOTREXATE WITH LEUCOVORIN RESCUE IN COMBINATION WITH OTHER
CHEMOTHERAPEUTIC AGENTS TO DELAY RECURRENCE IN PATIENTS WITH NONMETASTATIC
OSTEOSARCOMA WHO HAVE UNDERGONE SURGICAL RESECTION OR AMPUTATION FOR THE PRIMARY
TUMOR
I-22 RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY IN OSTEOSARCOMA
I-23 SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
I-24 TREATMENT OF RHEUMATOID ARTHRITIS
I-25 ADULT INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY OF THE HEAD, NECK, ABDOMINAL,
RENAL AND PERIPHERAL VESSELS
I-26 TREATMENT OF LIVER FLUKES
I-27 ADJUNCTIVE THERAPY TO DIET TO REDUCE THE RISK OF CORONARY ARTERY DISEASE
I-28 SELECTIVE ADULT VISCERAL ARTERIOGRAPHY
I-29 METASTATIC BREAST CANCER IN PREMENOPAUSAL WOMEN AS AN ALTERNATIVE TO OOPHORECTOMY
OR OVARIAN IRRADIATION
I-30 TREATMENT OF TINEA PEDIS
I-31 CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS IN THE SPINE AND
ASSOCIATED TISSUES
I-32 PEDIATRIC MYELOGRAPHY
I-33 ORAL USE OF DILUTED OMNIPAQUE INJECTION IN ADULTS FOR CONTRAST ENHANCED COMPUTED
TOMOGRAPHY OF THE ABDOMEN
I-34 ORAL USE IN ADULTS FOR PASS-THROUGH EXAMINATION OF THE GASTROINTESTINAL TRACT
I-35 PEDIATRIC CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING
I-36 ARTHROGRAPHY OF THE SHOULDER JOINTS IN ADULTS
I-37 RADIOGRAPHY OF THE TEMPOROMANDIBULAR JOINT IN ADULTS
I-38 CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS OF THE CENTRAL
I-39
NERVOUS SYSTEM IN CHILDREN (2 YEARS OF AGE AND OLDER)
TREATMENT OF ACUTE MYOCARDIAL INFARCTION
I-40 PRIMARY NOCTURNAL ENURESIS
I-41 MIGRAINE HEADACHE PROPHYLAXIS
I-42 HERPES ZOSTER
I-43 HERPES SIMPLEX ENCEPHALITIS
I-44 MAINTENANCE THERAPY IN HEALED DUODENAL ULCER PATIENTS AT DOSE OF 1 GRAM TWICE
DAILY
I-45 ACUTE TREATMENT OF VARICELLA ZOSTER VIRUS
I-46 USE IN PEDIATRIC COMPUTED TOMOGRAPHIC HEAD AND BODY IMAGING
I-47 TREATMENT OF PEDIATRIC PATIENTS WITH SYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS
I-48
(HIV) DISEASE
PEDIATRIC ANGIOCARDIOGRAPHY
I-49 TREATMENT OF TRAVELERS' DIARRHEA DUE TO SUSCEPTIBLE STRAINS OF ENTEROTOXIGENIC
ESCHERICHIA COLI
I-50 FOR USE IN WOMEN WITH AXILLARY NODE-NEGATIVE BREAST CANCER
I-51 TREATMENT OF PRIMARY DYSMENORRHEA AND FOR THE TREATMENT OF IDIOPATHIC HEAVY
MENSTRUAL BLOOD LOSS
I-52 PEDIATRIC EXCRETORY UROGRAPHY
I-53
I-54
TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA
RENAL CONCENTRATION CAPACITY TEST
I-55 HYPERTENSION
I-56 EROSIVE GASTROESOPHAGEAL REFLUX DISEASE
I-57 SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER
I-58 INITIAL TREATMENT OF ADVANCED OVARIAN CARCINOMA IN COMBINATION WITH OTHER APPROVED
CHEMOTHERAPEUTIC AGENTS
I-59
I-60
ENDOSCOPICALLY DIAGNOSED ESOPHAGITIS, INCLUDING EROSIVE AND ULCERATIVE
ESOPHAGITIS, AND ASSOCIATED HEARTBURN DUE TO GASTROESOPHAGEAL REFLUX DISEASE
SINGLE APPLICATION TREATMENT OF HEAD LICE IN CHILDREN TWO MONTHS TO TWO YEARS IN
AGE
I-61 FEMALE ANDROGENETIC ALOPECIA
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 6 of 62
EXCLUSI VI TY I NDI CATI ON
I-62 PREVENTION AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
I-63 ONCE DAILY TREATMENT AS INITIAL THERAPY IN THE TREATMENT OF HYPERTENSION
I-64 PREVENTION OF SUPRAVENTRICULAR TACHYCARDIAS
I-65 PREVENTION OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
I-66 UNCOMPLICATED GONORRHEA
I-67 TREATMENT OF ACUTE ASTHMATIC ATTACKS IN CHILDREN SIX YEARS OF AGE AND OLDER
I-68 CENTRAL PRECOCIOUS PUBERTY
I-69 SHORT TERM TREATMENT OF PATIENTS WITH SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE
(GERD), AND FOR THE SHORT TERM TREATMENT OF ESOPHAGITIS DUE TO GERD INCLUDING
ULCERATIVE DISEASE DIAGNOSED BY ENDOSCOPY
I-70 USE IN COMBINATION WITH 5-FLUOROURACIL TO PROLONG SURVIVAL IN THE PALLIATIVE
TREATMENT OF PATIENTS WITH ADVANCED COLORECTAL CANCER
I-71
I-72
VARICELLA INFECTIONS (CHICKENPOX)
PREVENTION OF CMV DISEASE IN TRANSPLANT PATIENTS AT RISK FOR CMV DISEASE
I-73 INITIATE AND MAINTAIN MONITORED ANESTHESIA CARE (MAC) SEDATION DURING DIAGNOSTIC
PROCEDURES
I-74 INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
I-75 TREATMENT OF ENDOSCOPICALLY DIAGNOSED EROSIVE ESOPHAGITIS
I-76 PREVENTION OF OSTEOPOROSIS
I-77 DERMAL INFECTIONS-TINEA PEDIS, TINEA CORPORIS, TINEA CRURIS DUE TO EPIDERMOPHYTON
FLOCCOSUM
I-78 CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY AND
INTRAVENOUS EXCRETORY UROGRAPHY
I-79 MANAGEMENT OF CHRONIC STABLE ANGINA AND ANGINA DUE TO CORONARY ARTERY SPASM
I-80 DIAGNOSIS AND LOCALIZATION OF ISCHEMIA AND CORONARY HEART DISEASE
I-81 PROPHYLAXIS IN DESIGNATED IMMUNOCOMPROMISED CONDITIONS TO REDUCE THE INCIDENCE OF
OROPHARYNGEAL CANDIDIASIS
I-82 TREATMENT OF TRAVELERS' DIARRHEA
I-83
I-84
I-85
ANGIOCARDIOGRAPHY, CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND
BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY IN CHILDREN
INTRAOPERATIVE AND POSTOPERATIVE TACHYCARDIA AND/OR HYPERTENSION
TREATMENT OF ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS WITH AIDS
I-86 TREATMENT OF SECONDARY CARNITINE DEFICIENCY
I-87 RENAL IMAGING AGENT FOR USE IN CHILDREN
I-88 MANAGEMENT OF ENDOMETRIOSIS
I-89 EPIDURAL USE IN LABOR AND DELIVERY AS AN ANALGESIC ADJUNCT TO BUPIVACAINE
I-90 INTENSIVE CARE UNIT SEDATION
I-91 MONOTHERAPY USE FOR HYPERTENSION
I-92 ADJUNCTIVE THERAPY IN THE MANAGEMENT OF HEART FAILURE
I-93 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN CHILDREN AGES 4-11 YEARS
I-94 USE WITH MRI IN ADULTS TO PROVIDE CONTRAST ENHANCEMENT AND FACILITATE
I-95
VISUALIZATION OF LESIONS IN THE BODY [EXCLUDING THE HEART]
TREATMENT OF LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION
I-96 TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
I-97 ORAL OR RECTAL USE IN CHILDREN FOR THE EXAMINATION OF THE GASTROINTESTINAL TRACT
I-98 TREATMENT OF CHILDREN WHO HAVE GROWTH FAILURE ASSOCIATED WITH CHRONIC RENAL
INSUFFICIENCY
I-99 PEDIATRIC ANESTHESIA IN CHILDREN 3 YEARS AND OLDER
I-100 TO DECREASE THE INCIDENCE OF CANDIDIASIS IN PATIENTS UNDERGOING BONE MARROW
I-101
TRANSPLANTATION WHO RECEIVE CYTOTOXIC CHEMOTHERAPY AND/OR RADIATION THERAPY
TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN-DEPENDENT
DIABETES MELLITUS AND RETINOPATHY
I-102 TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER
I-103 PROPHYLAXIS AGAINST PNEUMOCYSTIS CARINII PNEUMONIA IN INDIVIDUALS WHO ARE
IMMUNOCOMPROMISED AND CONSIDERED TO BE AT RISK OF DEVELOPING PNEUMOCYSTIS CARINII
PNEUMONIA
I-104 TREATMENT OF PULMONARY AND EXTRAPULMONARY ASPERGILLOSIS IN PATENTS WHO ARE
INTOLERANT OF OR WHO ARE REFRACTORY TO AMPHOTERICIN B THERAPY
I-105 TREATMENT OF METASTATIC CARCINOMA OF THE BREAST AFTER FAILURE OF FIRST-LINE OR
I-106
SUBSEQUENT CHEMOTHERAPY
TREATMENT OF ACROMEGALY
I-107 VAGINAL CANDIDIASIS
I-108 EXPANDED USE-FOR ICU PATIENTS UNDERGOING LONG-TERM INFUSION DURING MECHANICAL
VENTILATION
I-109 TYPHOID FEVER
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 7 of 62
EXCLUSI VI TY I NDI CATI ON
I-110 PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIOTHERAPY
I-111 TREATMENT OF PAGET'S DISEASE OF BONE
I-112 MANAGEMENT OF MODERATE TO SEVERE PAIN
I-113 TREATMENT OF PROSTATITIS
I-114 USE IN CHILDREN TO VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE BRAIN
I-115
(INTRACRANIAL LESIONS), SPINE, AND ASSOCIATED TISSUE
USE IN MRI IN ADULTS TO VISUALIZE LESIONS IN THE HEAD AND NECK
I-116 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
I-117 TO SLOW THE PROGRESSION FO CORONANY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY
HEART DISEASE
I-118 PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM FOLLOWING
KNEE REPLACEMENT SURGERY
I-119 TREATMENT OF ANEMIA CAUSED BY UTERINE LEIOMYOMATA IN WOMEN WHO FAIL IRON THERAPY
I-120 MAINTENANCE THERAPY FOR GASTRIC ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING
ACUTE ULCERS
I-121 EXPANDED PATIENT POPULATION -- USE IN ICU PATIENTS
I-122 PSORIASIS OF THE SCALP
I-123 RELIEF OF MILD TO MODERATE PAIN IN PATIENTS AGED 6 MONTHS AND OLDER
I-124 LEUCOCYTE LABELED SCINTIGRAPHY AS AN ADJUNCT IN THE LOCALIZATION OF INTRA-
ABDOMINAL INFECTION AND INFLAMMATORY BOWEL DISEASE
I-125 EXPANSION OF CONSCIOUS SEDATION INDICATION TO INCLUDE SHORT THERAPEUTIC PROCEDURES
I-126 ADJUNCT TO THALLIUM- 201 MYOCARDIAL PERFUSION IN PATIENTS UNABLE TO EXERCISE
I-127
ADEQUATELY
TREATMENT OF ACYCLOVIR-RESISTANT HERPES IN IMMUNOCOMPROMISED PATIENTS
I-128 IN PT W/ CH DISEASE AND HYPERCHOLESTEROLEMIA: REDUCE RISK TOTAL MORTALITY BY
REDUCING CORONARY DEATH; REDUCE RISK NON-FATAL MI; REDUCE RISK UNDERGOING
MYOCARDIAL REVASCULARIZATION PROCEDURES; REDUCTION ELEVATED TOTAL AND LDL CHOL
LEVELS...
I-129 TREATMENT OF ALCOHOL DEPENDENCE
I-130 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
I-131 PERIPHERAL ARTERIOGRAPHY
I-132 TREATMENT OF MANIC PHASE OF BIPOLAR DISORDER
I-133 MANAGEMENT OF CHRONIC STABLE ANGINA
I-134 HEART FAILURE POST MYOCARDIAL INFARCTION
I-135 BONE METASTASES ASSOCIATED WITH MULTIPLE MYELOMA
I-136 IDIOPATHIC CHRONIC URTICARIA
I-137 PREVENTION OF METAL-INDUCED HEART BURN, ACID INDIGESTION, AND SOUR STOMACH WHEN
TAKEN 30 MINUTES PRIOR TO CONSUMING FOOD OR BEVERAGES
I-138 TREATMENT OF ACUTE RECURRENT GENITAL HERPES
I-139 PALLIATIVE TREATMENT OF ADVANCED BREAST CANCER IN PRE- AND PERIMENOPAUSAL WOMEN
I-140 PREVENTION OF CYTOMEGALOVIRUS (CMV) DISEASE IN INDIVIDUALS WITH HIV INFECTION AT
RISK FOR DEVELOPING CMV DISEASE
I-141 TREATMENT OF HEMODYNAMICALLY STABLE PATIENTS WITHIN 24 HOURS OF ACUTE MYOCARDIAL
INFARCTION TO IMPROVE SURVIVAL
I-142
I-143
LOCALIZE MYOCARDIAL ISCHEMIA(REVERSIBLE DEFECT) AND INFARCTION (NON-REVERSIBLE
DEFECTS) IN EVALUATING MYOCARDIAL FUNCTION
EPISODIC TREATMENT OF RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT ADULTS
I-144 ENHANCEMENT OF MRI OF THE ADULT BODY INTERNAL ORGANS
I-145
I-146
0.1MMOL/KG AS A SINGLE INTRAVEOUS BOLUS FOR MRI OF THE CNS IN CHILDREN
CONTRAST ENHANCEMENT AND FACILITATION OF VISUALIZATION OF EXTRACRANIAL HEAD AND
NECK LESIONS
I-147 PREVENTION OF GALLSTONE FORMATION IN OBESE PATIENTS EXPERIENCING RAPID WEIGHT LOSS
I-148
I-149
TREATMENT OF ACUTE PNEUMOCYSTIC CARINI PNEUMONIA (PCP) IN HIV-INFECTED PATIENTS
WHOSE ALVEOLAR-ARTERIAL OXYGEN DIFFERENCE (AaDO2) IS LESS THAN OR EQUAL TO 55 TORR
TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER
I-150 TREATMENT OF OBSESSIVE COMPULSIVE DISORDER AND PANIC DISORDER
I-151 PREVENTION OF AND PREVENTION OF FURTHER POSTOPERATIVE NAUSEA AND VOMITING IN
PEDIATRIC PATIENTS RECEIVING GENERAL ANESTHESIA
I-152 SLOWING THE PROGRESSION OF CORONARY ATHEROSCLEROSIS AND REDUCING THE RISK OF ACUTE
CORONARY EVENTS
I-153
I-154
MANAGEMENT OF SEVERE SPASTICITY [ENCOMPASES SPINAL AND CEREBRAL ORIGIN]
PATIENT POPULATION ALTERED TO INCLUDE PEDIATRIC USE
I-155 TREATMENT OF ONCHOMYCOSIS DUE TO DERMATOPHYTES (TINEA UNGUIUM) OF THE TOENAIL WITH
OR WITHOUT FINGERNAIL INVOLVEMENT
I-156 ADDITIONAL DATA REGARDING THE SAFE USE OF NORVASC IN PATIENTS WITH HEART FAILURE
I-157 TREATMENT OF ACUTE UNCOMPLICATED CYSTITIS IN FEMALES
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 8 of 62
EXCLUSI VI TY I NDI CATI ON
I-158 TREATMENT OF OSTEOLYTIC BONE METASTASES OF BREAST CANCER
I-159 FOR HYPERCHOLESTEROLEMIC PATIENTS WITHOUT CLINICALLY EVIDENT HEART DISEASE REDUCE
THE RISK OF MYOCARDIAL INFARCTION, REVASCULARIZATION, AND DEATH DUE TO
CARDIOVASCULAR CAUSES WITH NO INCREASE IN DEATH FROM NON-CARDIOVASCULAR CAUSES
I-160 TREATMENT OF BACTERIAL CORNEAL ULCERS
I-161 TREATMENT OF ADULT-ONSET OR CHILDHOOD-ONSET ADULT GROWTH HORMONE DEFICIENCY
I-162 FOR USE IN PATIENTS 6-11 YEARS OF AGE
I-163 TREATMENT OF PHOTOPHOBIA
I-164 CHRONIC BACTERIAL PROSTATITIS
I-165 MANAGEMENT OF ADULTS WITH ACTIVE, CLASSIC AND DEFINITIVE RHEUMATOID ARTHRITIS WHO
HAVE HAD INSUFFICIENT THERAPEUTIC RESPONSE TO OR ARE INTOLERANT OF AN ADEQUATE
TRIAL OF FULL DOSES OF ONE OR MORE NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
I-166 TREATMENT OF BULIMIA
I-167
I-168
I-169
COMPLICATED INTRA-ABDOMINAL INFECTIONS (USED IN COMBINATION WITH METRONIDAZOLE)
CAUSED BY MIXED AEROBIC/ANAEROBIC PATHOGENS
MANAGEMENT OF LOCALLY CONFINED STAGE B2-C METASTATIC CARCINOMA OF THE PROSTATE (IN
COMBINATION WITH LHRH AGONISTS)
USE IN COMBINATION WITH CORTICOSTEROIDS AS INITIAL CHEMOTHERAPY FOR THE TREATMENT
OF PATIENTS WITH PAIN RELATED TO ADVANCED HORMONE-REFRACTORY PROSTATE CANCER
I-170 PROPHYLACTIC USE DURING HEAD LICE EPIDEMICS
I-171 RELIEF OF SYMPTOMS OF THE COMMON COLD
I-172 TREATMENT OF INITIAL EPISODE OF GENITAL HERPES
I-173 PREOPERATIVELY FOR THE PREVENTION OF INFECTION IN TRANSRECTAL PROSTATE BIOPSY
I-174 PELVIC INFLAMMATORY DISEASE
I-175 TREATMENT OF TINEA CORPORIS AND TINEA CRURIS
I-176 TREATMENT OF POSTOPERATIVE INFLAMMATION IN PATIENTS WHO HAVE UNDERGONE CATARACT
EXTRACTION
I-177 TX OF MODERATE ACNE VULGARIS IN FEMALES,GREATER OR EQUAL TO 15YRS OF AGE,WHO HAVE
NO KNOWN CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY,DESIRE CONTRACEPTION,HAVE
ACHIEVED MENARCHE AND ARE UNRESPONSIVE TO TOPICAL ANTI-ACNE MEDICATIONS
I-178 TREATMENT OF ONCHOMYCOSIS OF THE FINGERNAIL WITHOUT CONCOMITANT ONCHOMYCOSIS OF
THE TOENAIL WITH A PULSE DOSING REGIMEN
I-179 NOSOCOMIAL PNEUMONIA-MILD TO MODERATE AND SEVERE CAUSED BY HAEMOPHILUS INFLUENZAE
OR KLEBSIELLA PNEUMONIAE
I-180
I-181
TREATMENT OF PLANTAR TINEA PEDIS (MOCCASIN TYPE)
TREATMENT OF PATIENTS WITH COMPLEX PARTIAL SEIZURES WITH AND WITHOUT SECONDARY
GENERALIZATION
I-182 TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME
I-183 MAINTENANCE THERAPY IN THE MANAGEMENT OF MILD TO MODERATE ASTHMA IN PEDIATRIC
PATIENTS AGES 6-11
I-184
I-185
TREATMENT OF PANIC DISORDER AT A RECOMMENDED DOSE RANGE OF 1 TO 2MG/DAY (MAXIMUM
OF 4MG)
PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
I-186
I-187
TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR CAUSED BY OR PRESUMED TO BE CAUSED BY
PITYROSPORUM ORBICULARE (ALSO KNOWN AS MALASSEZIA FURFUR OR M. ORBICULARE)
PREVENTION OF FRACTURES IN THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
I-188 TREATMENT OF ACUTE SINUSITIS AND ACUTE EXACERBATION OF CHRONIC SINUSITIS
I-189 TREATMENT OF ACUTE OTITIS MEDIA IN PEDIATRIC PATIENTS
I-190 PLANAR IMAGING AS A SECOND LINE DIAGNOSTIC DRUG AFTER MAMMOGRAPHY TO ASSIST IN THE
EVALUATION OF BREAST LESIONS IN PATIENTS WITH AN ABNORMAL MAMMOGRAM OR A PALPABLE
BREAST MASS
I-191 ENDOMETRIAL THINNING AGENT PRIOR TO ENDOMETRIAL ABLATION FOR DYSFUNCTIONAL UTERINE
BLEEDING
I-192 THE PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM, IN
PATIENTS UNDERGOING ABDOMINAL SURGERY WHO ARE AT RISK FOR THROMBOEMBOLIC
I-193
I-194
COMPLICATIONS AND A NEW DOSAGE REGIMEN, 40MG ONCE DAILY, FOR THIS INDICATION
TREATMENT OF PANIC DISORDER IN A RECOMMENDED DOSE RANGE OF 50 TO 200MG/DAY
CONGESTIVE HEART FAILURE
I-195 FOR USE OF LANSOPRAZOLE IN COMBINATION WITH CLARITHROMYCIN AND AMOXICILLIN FOR THE
ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE
OR A ONE-YEAR HISTORY OF DUODENAL ULCER
I-196 ACUTE TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
I-197 MAINTENANCE OF HEALING OF DUODENAL ULCER
I-198 FOR THE USE OF LANSOPRAZOLE IN COMBINATION WITH AMOXICILLIN FOR THE ERADICATION OF
HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE OR A ONE-YEAR
HISTORY OF A DUODENAL ULCER
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 9 of 62
EXCLUSI VI TY I NDI CATI ON
I-199 MONOTHERAPY AND COMBINATION THERAPY WITH SULFONYL UREAS IN THE TREATMENT OF TYPE
II DIABETES
I-200
I-201
TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR
EMPIRICAL THERAPY FOR FEBRILE NEUTROPENIC PATIENTS
I-202 SECOND-LINE TREAMENT OF AIDS-RELATED KAPOSI'S SARCOMA
I-203 MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
I-204 USE IN PEDIATRIC PATIENTS BETWEEN THE AGES OF 6 AND 11 FOR THE TREATMENT OF THE
NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS
I-205 INITIAL ANTICONVULSANT TREATMENT OF STATUS EPILEPTICUS
I-206 TREATMENT OF EDEMA ASSOCIATED WITH CHRONIC RENAL FAILURE
I-207 FOR THE SUPPRESSION OF RECURRENT EPISODES OF GENITAL HERPES IN IMMUNOCOMPETENT
ADULTS
I-208 TREATMENT OF OBSESSIVE COMPULSIVE DISORDER IN THE PEDIATRIC POPULATION
I-209
I-210
PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT)
TO SLOW THE PROGRESSION OF CORONARY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY
HEART DISEASE AS PART OF A TREATMENT STRATEGY TO LOWER TOTAL AND LDL CHOLESTEROL
TO TARGET LEVELS
I-211 FOR USE IN PEDIATRIC POPULATION
I-212 TREATMENT OF SYMPTOMS OF DRY MOUTH IN PATIENTS WITH SJOGREN'S SYNDROME
I-213 TEMPORARY RELIEF OF PAIN AND PHOTOPHOBIA IN PATIENTS UNDERGOING CORNEAL REFRACTIVE
SURGERY
I-214 TREATMENT OF OSTEOPOROSIS
I-215 PRE-PROCEDURAL APPLICATION TO ADULT MALE GENITAL SKIN PRIOR TO SITE-SPECIFIC
SUBCUTANEOUS INFILTRATION WITH LIDOCAINE FOR THE REMOVAL OF GENITAL WARTS
I-216 FOR THE LONG-TERM TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE
MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD, INCLUDING CHRONIC
BRONCHITIS AND EMPHYSEMA
I-217
I-218
PREVENTION (DURING AND FOLLOWING HOSPITALIZATION) OF DEEP VEIN THROMBOSIS, WHICH
MAY LEAD TO PULMONARY EMBOLISM, IN PATIENTS UNDERGOING HIP REPLACEMENT SURGERY
USE OF LIPITOR AS AN ADJUNCTIVE THERAPY TO DIET FOR THE TREATMENT OF PATIENTS WITH
I-219
I-220
I-221
ELEVATED SERUM TRIGLYCERIDE LEVELS (FREDERICKSON TYPE IV)
USE OF LIPITOR BY PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDERICKSON TYPE
III) WHO DO NOT RESPOND ADEQUATELY TO DIET
TREATMENT OF EPISODIC- HEARTBURN, ACID INDIGESTION AND SOUR STOMACH
TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WITH AN ENLARGED PROSTATE
TO IMPROVE SYMPTOMS, REDUCE THE RISK OF ACUTE URINARY RETENTION AND REDUCE THE
RISK OF THE NEED OF SURGERY
I-222
I-223
PREVENTION OF ISCHEMIC COMPLICATIONS OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL
INFARCTION, WHEN CONCURRENTLY ADMINISTERED WITH ASPIRIN
USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH ALLERGIC AND
NONALLERGIC-PERENNIAL RHINITIS IN CHILDREN AGE 6-11 YEARS
I-224 FOR THE USE IN PEDIATRIC PATIENTS 4 TO 11 YEARS OF AGE FOR THE MANAGEMENT OF THE
NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS
I-225
I-226
USE IN PATIENTS WITH PREVIOUS MI AND NORMAL CHOLESTEROL LEVELS, TO REDUCE RISK OF
RECURRENT MI, MYOCARDIAL REVASCULARIZATION, AND CEREBROVASCULAR DISEASE EVENTS
FIRST-LINE THERAPY FOR THE TREATMENT OF ADVANCED CARCINOMA OF THE OVARY IN
COMBINATION WITH CISPLATIN
I-227
I-228
SHORT-TERM TREATMENT OF SYMPTOMATIC GASTROESPHAGEAL REFLUX DISEASE (GERD)
PREVENTION OF MEAL INDUCED HEARTBURN AT A DOSE OF 75MG TAKEN 30-60MIN PRIOR TO A
MEAL
I-229 PRILOSEC (OMEPRAZOLE), AMOXICILLIN, AND CLARITHROMYCIN FOR THE ERADICATION OF H.
PYLORI IN PATIENTS WITH DUODENAL ULCER DISEASE
I-230 IN COMBINATION WITH CIS-PLATIN, FOR THE FIRST LINE TREATMENT OF NON-SMALL CELL
LUNG CANCER IN PATIENTS WHO ARE NOT CANDIDATES FOR POTENTIALLY CURATIVE SURGERY
I-231
AND/OR RADIATION
TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER AFTER
FAILURE OF PRIOR CHEMOTHERAPY
I-232 TREATMENT OF RECURRENT MUCOCUTANEOUS HERPES SIMPLEX INFECTIONS IN HIV-AFFECTED
PATIENTS AT A DOSE OF 500MG TWICE DAILY
I-233 PROPHYLACTIC USE TO REDUCE PERIOPERATIVE BLOOD LOSS AND THE NEED FOR BLOOD
TRANSUFSION IN PATIENTS UNDERGOING CARDIOPULMONARY BYPASS IN THE COURSE OF
CORONARY ARTERY BYPASS GRAFT SURGERY
I-234 FOR USE IN COMBINATION WITH CISPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS
WITH INOPERABLE LOCALLY ADVANCED (STAGE IIIA OR IIIB) OR METASTATIC (STAGE IV)
NON-SMALL CELL LUNG CANCER
I-235 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 12 YEARS OF AGE AND OLDER
I-236 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 10 of 62
EXCLUSI VI TY I NDI CATI ON
I-237 MAINTENANCE TREATMENT OF ASTHMA AND PREVENTION OF BRONCHOSPASM IN PATIENTS 4 YEARS
OF AGE AND OLDER
I-238 ADJUNCTIVE TREATMENT OF LENNOX-GASTAUT SYNDROME IN PEDIATRIC AND ADULT PATIENTS
I-239 TREATMENT OF PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
I-240 MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM AND RESULTANT METABOLIC BONE DISEASE
IN PATIENTS WITH MODERATE TO SEVERE CHRONIC RENAL FAILURE (CCR 15 TO 55ML/MIN) NOT
YET ON DIALYSIS
I-241 USE IN PHOTODYNAMIC THERAPY (PDT) FOR REDUCTION OF OBSTRUCTION AND PALLIATION OF
SYMPTOMS IN PATIENTS WITH COMPLETELY OR PARTIALLY OBSTRUCTING ENDOBRONCHIAL
NONSMALL CELL LUNG CANCER
I-242 TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE
AND IN THE TREATMENT OF VULVAR AND VAGINAL ATROPHY IN WOMEN WITH AN INTACT UTERUS
I-243 USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH THE COMMON COLD IN
CHILDREN AGE 5 TO 11 YEARS
I-244 REDUCE THE INCIDENCE OF BREAST CANCER IN WOMEN AT HIGH RISK FOR BREAST CANCER
I-245 TREATMENT OF ACUTE SINUSITIS
I-246 TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
I-247 USE IN CONVERSION TO MONOTHERAPY IN ADULTS WITH PARTIAL SEIZURES WHO ARE RECEIVING
TREATMENT WITH A SINGLE ENZYME-INDUCING ANTIEPILEPTIC DRUG
I-248 INPATIENT TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITH/WITHOUT PULMONARY EMBOLISM
WHEN ADMIN WITH WARFARIN SODIM AND OUTPATIENT TREATMENT OF ACUTE DEEP VEIN
THROMBOSIS WITHOUT PULMONARY EMBOLISM WHEN ADMIN WITH WARFARIN SODIUM
I-249 TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS WITH COMPENSATED LIVER DISEASE
PREVIOUSLY UNTREATED WITH ALPHA INTERFERON THERAPY
I-250 PRIMARY PREVENTION OF CORONARY HEART DISEASE IN PATIENTS WITHOUT SYMPATOMATIC
CARDIOVASCULAR DISEASE WHO HAVE AVERAGE TO MODERATELY ELEVATED TOTAL-C AND LDL-C
AND BELOW AVERAGE HDL-C
I-251 TREATMENT OF GENERALIZED ANXIETY DISORDER
I-252 NEW COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET
PLUS METFORMIN
I-253 COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET
PLUS INSULIN
I-254
I-255
I-256
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS (LOSS OF BONE MASS)
PREVENTION OF PNEUMOCYSTIS CARINII PNEUMONIA (PCP)
USE IN TREATMENT OF SMALL CELL LUNG CANCER SENSITIVE DISEASE AFTER FAILURE OF
FIRST-LINE CHEMOTHERAPY
I-257 TREATMENT OF CHRONIC HEPATITIS B ASSOCIATED WITH EVIDENCE OF HEPATITIS B VIRAL
REPLICATION AND ACTIVE LIVER INFLAMATION
I-258 FOR PERENNIAL NONALLERGIC RHINITIS FOR AGES 4 AND ABOVE
I-259 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM,
IN PATIENTS UNDERGOING HIP REPLACEMENT SURGERY
I-260
I-261
EXPANDED PEDIATRIC USE IN CHILDREN YOUNGER THAN ONE MONTH OF AGE TO BIRTH (WITH A
GESTATIONAL AGE OF 37 WEEKS OR GREATER)
TREATMENT OF SOCIAL ANXIETY DISORDER
I-262 TREATMENT OR PREVENTION OF BRONCHOSPASM WITH REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE
AND FOR THE PREVENTION OF EXERCISE INDUCED BRONCHOSPASM IN CHILDREN AGES 4-12
I-263 TREATMENT OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL INFARCTION FOR THE
PREVENTION OF ISCHEMIC COMPLICATIONS IN PATIENTS ON CONCURRENT ASPIRIN THERAPY
I-264
I-265
PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIATION, INCLUDING TOTAL BODY
IRRADIATION (TBI) AND FRACTIONATED ABDOMINAL RADIATION
TREATMENT OF ATOPIC DERMATITIS IN PEDIATRIC PATIENTS 6 YEARS AND OLDER
I-266 USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS AGES 2-16 YEARS WITH
PARTIAL ONSET SEIZURES
I-267 USE IN PEDIATRIC PATIENTS 3 MONTHS OLD AND OLDER - FOR CORTICOSTEROID-RESPONSIVE
DERMATOSES
I-268 PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 7-11 YEARS OF AGE
I-269 PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH HIGHLY EMETOGENIC CANCER
I-270
CHEMOTHERAPY, INCLUDING CISPLATIN
ADJUVANT TREATMENT OF NODE-POSITIVE BREAST CANCER ADMINISTRERED SEQUENTIALLY TO
STANDARD DOXORUBICIN-CONTAINING COMBINATION CHEMOTHERAPY
I-271 TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
I-272 TREATMENT OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN MEN AND WOMEN RECEIVING
GLUCOCORTICOIDS IN A DAILY DOSE EQUIVALENT TO 7.5MG OR GREATER OF PREDNISONE AND
WHO HAVE LOW BONE MINERAL DENSITY
I-273 ADJUNCT TO DIET TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(HETEROZYGOUS FAMILIAL AND NON FAMILIAL) AND MIXED DYSLIPIDEMIA (FREDERICKSON
TYPES IIA AND IIB)
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 11 of 62
EXCLUSI VI TY I NDI CATI ON
I-274 USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED
TONIC-CLONIC SEIZURES
I-275 USE IN COMBINATION WITH METFORMIN AND SULFONYLUREA IN PATIENTS WITH TYPE 2
DIABETES
I-276 USE OF REZULIN IN COMBINATION WITH METFORMIN AND SULFONYLUREAS IN PATIENTS WITH
TYPE 2 DIABETES
I-277 TREATMENT OF TYPE III HYPERLIPOPROTEINEMIA
I-278
I-279
TREATMENT OF PATIENTS WITH ISOLATED HYPERTRIGLYCERIDEMIA (FREDERICKSON TYPE IV)
TREATMENT OF POST-TRAUMATIC STRESS DISORDER
I-280 USE OF CARNITOR INJECTION FOR THE PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY
IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
I-281
I-282
INCREASING HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA (HETEROZYGOUS
FAMILIAL AND NONFAMILIAL) AND MIXED DYSLIPIDEMIA (FREDERICKSON TYPES IIA AND IIB)
TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG
CANCER AFTER FAILURE OF PRIOR PLATINUM-BASED CHEMOTHERAPY
I-283 TO REDUCE THE INCIDENCE OF MODERATE TO SEVERE XEROSTOMIA IN PATIENTS UNDERGOING
POST-OPERATIVE RADIATION TREATMENT FOR HEAD AND NECK CANCER, WHERE THE RADIATION
PORT INCLUDES A SUBSTANTIAL PORTION OF THE PAROTID GLANDS
I-284 TO REDUCE THE NUMBER OF ADENOMATOUS COLORECTAL POLYPS IN FAMILIAL ADENOMATOUS
POLYPOSIS PATIENTS AS AN ADJUNCT TO USUAL CARE
I-285 TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN ADULTS AND
CHILDREN 3 YEARS OF AGE AND OLDER
I-286 TREATMENT OF PATIENTS WITH FREDERICKSON TYPE III
I-287 USE OF PRAVASTATIN IN PATIENTS WITH EVIDENT CORONARY HEART DISEASE TO REDUCE THE
RISK OF TOTAL MORTALITY BY REDUCING CORONARY DEATH
I-288 CHANGES IN SEVERAL SECTIONS OF THE INSERT TO INCORPORATE STATEMENTS CONCERNING THE
USE OF HIGH DOSES OF LISINOPRIL TO REDUCE THE RISK OF THE COMBINED OUTCOMES OF
MORTALITY AND HOSPITALIZATION IN PATIENTS WITH CONGESTIVE HEART FAILURE
I-289 USE OF AVANDIA IN COMBINATION WITH A SULFONYLUREA IN PATIENTS WITH TYPE 2 DIABETES
MELLLITUS WHEN DIET AND EXERCISE WITH EITHER SINGLE AGENT DOES NOT ACHIEVE
I-290
ADEQUATE GLYCEMIC CONTROL
PREVENTION OF CORTICOSTEROID-INDUCED OSTEOPOROSIS
I-291 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
I-292 TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
I-293 TREATMENT OF CORTICOSTEROID-INDUCED OSTEOPOROSIS
I-294 TREATMENT OF UNCOMPLICATED ACUTE ILLNESS DUE TO INFLUENZA A AND B IN PEDIATRIC
PATIENTS 7 YEARS AND OLDER WHO HAVE BEEN SYMPTOMATIC FOR NO MORE THAN 2 DAYS
I-295 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR WOMEN WITH AN INTACT UTERUS
I-296 LONG-TERM INTRAVENOUS TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH THE
SCLERODERMA SPECTRUM OF DISEASE IN NYHA CLASS III AND CLASS IV PATIENTS WHO DO NOT
RESPOND TO CONVENTIONAL THERAPY
I-297 SHORT-TERM TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
I-298 TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IIA AND IIB HYPERLIPOPROTEINEMIA
I-299 USE OF CAMPTOSAR AS A COMPONENT OF FIRST-LINE THERAPY IN COMBINATION WITH 5-
FLUROURACIL AND LEUCOVARIN FOR PATIENTS WITH METASTATIC CARCINOMA OF THE COLON OR
RECTUM
I-300 PROPHYLAXIS FOR ASTHMA IN CHILDREN 2-5 YEARS OF AGE
I-301 TREATMENT OF SIGNS AND SYMPTOMS OF ALLERGIC CONJUNCTIVITIS
I-302 TREATMENT OF PEDIATRIC PATIENTS WITH PRADER-WILLI SYNDROME
I-303 INCREASING HDL-CHOLESTEROL IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA AND MIXED
DYSLIPIDEMIAS
I-304 TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IV
I-305 TREATMENT OF LEVOFLOXACIN SUSCEPTIBLE STRAINS OF PENICILLIN-RESISTANT
I-306
STREPTOCOCCUS PNEUMONIAE IN PATIENTS WITH COMMUNITY ACQUIRED PNEUMONIA
INDUCTION OF SPERMATOGENESIS IN MEN WITH PRIMARY AND SECONDARY HYPOGONADOTROPIC
HYPOGONADISM IN WHOM THE CAUSE OF INFERTILITY IS NOT DUE TO PRIMARY TESTICULAR
FAILURE
I-307 NEW COMBINATION USE OF METFORMIN AND INSULIN IN TYPE 2 DIABETES
I-308 TREATMENT OF PEDIATRIC PATIENTS WITH POLYARTICULAR COURSE JUVENILE RHEUMOTOID
I-309
ARTHRITIS WHO RESPONDED INADEQUATELY TO SALICYLATES OR OTHER NSAIDS
USE OF ACTONEL 35MG ONCE A WEEK TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
I-310 REDUCTION IN RISK OF MYOCARDIAL INFARCTION, STROKE, AND DEATH FROM CARDIOVASCULAR
CAUSES
I-311 ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS AGE
3 TO 12 YEARS
I-312 FIRST LINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR
HORMONE RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 12 of 62
EXCLUSI VI TY I NDI CATI ON
I-313 EXTENSION OF INDICATION TO PROVIDE FOR MAINTENANCE OF RESPONSE
I-314 TOPICAL ANESTHETIC FOR SUPERFICIAL MINOR SURGERY OF GENITAL MUCOUS MEMBRANES AND
AS AN ADJUNCT FOR LOCAL INFILTRATION ANESTHESIA IN GENITAL MUCOUS MEMBRANES
I-315 THROMBOPROPHYLAXIS OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY
EMBOLISM,IN MEDICAL PATIENTS WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS DUE
TO SEVERELY RESTRICTED MOBILITY DURING ACUTE ILLNESS
I-316 TREATMENT OF NSAID-ASSOCIATED GASTRIC ULCER PATIENTS WHO CONTINUE NSAID USE AND
REDUCING RISK OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS WITH HISTORY OF
I-317
DOCUMENTED GASTRIC ULCER WHO REQUIRE USE OF AN NSAID
PROPHYLAXIS OF INFLUENZA IN ADULTS AND ADOLESCENTS 13 YEARS AND OLDER
I-318 FIRSTLINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR
HORMONE RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER
I-319 USE FOR SUSPECTED OR CONFIRMED METHANOL POISONING, EITHER ALONE OR IN COMBINATION
WITH HEMODIALYSIS
I-320
I-321
TREATMENT OF TYPE 2 DIABETES IN PEDIATRIC PATIENTS (AGES 10-16 YEARS)
JUVENILE RHEUMATOID ARTHRITIS
I-322 USE OF DIPRIVAN IN PATIENTS 3 MONTHS TO 16 YEARS
I-323 COLORECTAL CANCER
I-324 REDUCING NEUROLOGIC DISABILITY AND/OR FREQUENCY OF CLINICAL RELAPSES IN PATIENTS
WITH SECONDARY (CHRONIC) PROGRESSIVE, PROGRESSIVE RELAPSING, OR WORSENING
RELAPSING-REMITTING MULTIPLE SCLEROSIS
I-325 PREVENTION OF RELAPSE AND RECURRENCE OF DEPRESSION
I-326 GENERALIZED ANXIETY DISORDER
I-327 SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN
PATIENTS 5 YEARS AND OLDER
I-328 PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 5-6 YEARS OF AGE
I-329 UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
I-330 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND CONTROL OF DAYTIME AND NIGHTTIME
HEARTBURN SYSTOMS IN PATIENTS WITH GERD
I-331 TREATMENT OF MODERATE ACNE VULGARIS
I-332 EMPIRIC THERAPY IN FEBRILE NEUTROPENIC PATIENTS WITH SUSPECTED FUNGAL INFECTIONS
I-333
I-334
(EFTN)
TOPICAL TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR DUE TO MALASSEZIA FURFUR
(FORMERLY PITYROSPORUM ORBICULARE)
LONG-TERM TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE
WHO FAIL TO MANIFEST CATCH-UP GROWTH BY TWO YEARS OF AGE
I-335 ADJUNCTIVE THERAPY IN PATIENTS TWO YEARS AND OLDER WITH SEIZURES ASSOCIATED WITH
LENNOX-GASTAUT SYNDROME
I-336 EXPANSION OF INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH PREDOMINATELY
CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO PATHOLOGIC MYOPIA OR
PRESUMED OCULAR HISTOPLASMOSIS
I-337 PATHOLOGICAL HYPERSECRETION ASSOCIATED WITH ZOLLINGER-ELLISON SNYDROME
I-338 MANAGEMENT OF ACUTE PAIN IN ADULTS AND TREATMENT OF PRIMARY DYSMENORRHEA
I-339 TREATMENT OF HEPATITIS B IN PEDIATRIC PATIENTS AGES 2-17 YEARS
I-340 ATOPIC DERMATITIS IN PEDIATRIC PATIENTS AGES 2-5
I-341 BREAST CANCER COMBINATION THERAPY
I-342 USE OF FORADIL FOR LONG-TERM, TWICE DAILY (MORNING AND EVENING) ADMINISTRATION IN
THE MAINTENANCE TREATMENT OF BRONCHO-CONSTRICTION IN PATIENTS WITH COPD INCLUDING
CHRONIC BRONCHITIS AND EMPHYSEMA
I-343 USE OF COREG FOR SEVERE HEART FAILURE
I-344 ACNE VULGARIS
I-345 TREATMENT OF POSTTRAUMATIC STRESS DISORDER
I-346
I-347
TREATMENT OF SYMPTOMATIC GASTRO ESOPHAGEAL REFLUX DISEASE (GERD)
TREATMENT OR PREVENTION OF BRONCHOSPASM IN CHILDREN 6 YEARS OF AGE AND OLDER WITH
OBSTRUCTIVE AIRWAY DISEASE
I-348
I-349
LONG-TERM, TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE MAINTENANCE
TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD (INCLUDING EMPHYSEMA AND CHRONIC
BRONCHITIS)
ACUTE CORONARY SYNDROME
I-350 TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND
GIRLS AT LEAST ONE YEAR POSTMENARCHAL, AGES 10 TO 17 YEARS, WITH A RECOMMENDED
DOSING RANGE OF 10 TO 40MG ONCE DAILY
I-351 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR ALL STRENGTHS
I-352 ANTICOAGULANT IN PATIENTS WITH OR AT RISK FOR HEPARIN-INDUCED THROMBOCYTOPENIA
I-353
UNDERGOING PERCUTANEOUS CORONARY INTERVENTIONS (PCI)
TREATMENT OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 13 of 62
EXCLUSI VI TY I NDI CATI ON
I-354 MANAGEMENT OF POST HERPETIC NEURALGIA
I-355 PREMENSTRUAL DYSPHORIC DISORDER
I-356 TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS, INCLUDING ZOLLINGER-ELLISON
SYNDROME
I-357 TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
I-358 TREATMENT OF PANIC DISORDER
I-359 TREATMENT OF VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH THE MENOPAUSE
I-360 TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN CHILDREN AGES
TWO UP TO AGE THREE
I-361 TREATMENT OF MULTIPLE MYELOMA AND DOCUMENTED BONE METASTASES FROM SOLID TUMORS, IN
CONJUNCTION WITH STANDARD ANTINEOPLASTIC THERAPY. PROSTATE CANCER SHOULD HAVE
PROGRESSED AFTER TREATMENT WITH AT LEAST ONE HORMONAL THERAPY
I-362
I-363
TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA
ADJUVANT TREATMENT OF POST MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE EARLY
BREAST CANCER
I-364
I-365
TREATMENT OF COMMUNITY-ACQUIRED PNEUMONIA IN ADULTS
TREATMENT OF HEART FAILURE (NYHA CLASS II-IV) IN PATIENTS WHO ARE INTOLERANT TO AN
ACE INHIBITOR
I-366 PREVENTION OF RELAPSE FOLLOWING LONG-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER
I-367 COMBINATION THERAPY WITH THIAZOLIDINEDIONE TO LOWER BLOOD GLUCOSE IN PTS WHOSE
I-368
HYPERGLYCEMIA CANNOT BE CONTROLLED BY DIET/EXERCISE PLUS MONOTHERAPY WITH ANY OF
THE FOLLOWING AGENTS:METFORMIN,SULFONYLUREAS,REPAGLINIDE,OR THIAZOLIDINEDIONES
USE OF GLUCOVANCE WITH A THIAZOLIDINEDIONE WHEN GLYCEMIC CONTROL IS NOT OBTAINED
WITH GLUCOVANCE ALONE
I-369 PREVENTION AND TREATMENT OF POSTOPERATIVE NAUSEA AND VOMITING
I-370 TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN CHILDREN, AGES 8-13
YEARS, WITH RECOMMENDED DOSE OF 20MG ONCE DAILY AND IN ADOLESCENTS, AGES 14-18
WITH A RECOMMENDED DOSE OF 40MG ONCE DAILY
I-371 HELICOBACTER PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
I-372 NOSOCOMIAL PNEUMONIA
I-373 TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY
I-374 SHORT TERM TOPICAL TREATMENT OF MILD TO MODERATE PLAQUE-TYPE PSORIASIS OF NON
SCALP REGIONS
I-375 FIRST LINE THERAPY FOR THE REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH
OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION
I-376 TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE
I-377
CHRONIC MYELOID LEUKEMIA (CML)
USE OF BRAVELLE FOR MULTIPLE FOLLICULAR DEVELOPMENT (CONTROLLED OVARIAN
STIMULATION) DURING ASSISTED REPRODUCTIVE TECHNOLOGY CYCLES IN PATIENTS WHO HAVE
PREVIOUSLY RECEIVED PITUITARY SUPPRESSION
I-378 RELIEF OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS
2 YEARS OF AGE AND OLDER
I-379 USE TAXOTERE IN COMBINATION WITH CISPLATIN FOR THE TREATMENT OF PATIENTS WITH
UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHO HAVE
NOT PREVIOUSLY RECEIVED CHEMOTHERAPY FOR THIS CONDITION
I-380 TO TREAT PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER AT RISK FOR
EMERGENT SUICIDAL BEHAVIOR
I-381 TREATMENT OF COLD SORES (HERPES LABIALIS) IN ADULT AND ADOLESCENT PATIENTS 12
YEARS OF AGE AND OLDER
I-382 FOR NEWLY-DIAGNOSED HIGH GRADE MALIGNANT GLIOMA PATIENTS AS AN ADJUNCT TO SURGERY
AND RADIATION
I-383 TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY
I-384 USE IN COMBINATION WITH INSULIN FOR THE TREATMENT OF PATIENTS WITH TYPE 2 DIABETES
MELLITUS
I-385
I-386
MODIFICATION OF THE INDICATION FOR COMMUNITY ACQUIRED PNEUMONIA TO ADD"INCLUDING
PENICILLIN-RESISTANT STRAINS, MIC PENICILLIN>=2MCG/ML TO STREPTOCOCCUS PNEUMONIAE
RAPAMUNE (SIROLIMUS) WITHIN AN IMMUNOSUPPRESSIVE REGIMEN THAT WOULD ALLOW FOR THE
WITHDRAWAL OF CYCLOSPORINE 2 TO 4 MONTHS AFTER RENAL TRANSPLANTATION IN PATIENTS
CONSIDERED AT LOW TO MODERATE IMMUNOLOGIC RISK FOR RENAL TRANSPLANT REJECTION
I-387 ADJUNCTIVE THERAPY OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS GREATER THAT OR EQUAL
TO 2 YEARS OF AGE
I-388 TREATMENT OF PATIENTS WITH LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL
INFARCTION
I-389 SUPRESSION OF RECURRENT GENITAL HERPES IN HIV-INFECTED INDIVIDUALS
I-390 USE IN PTS AT HIGH RISK CORONARY EVENTS DUE TO EXISTING CORONARY HEART
DISEASE,DIABETES,PERIPHERAL VESSEL DISEASE,STROKE HISTORY,OTHER CV DISEASE TO
REDUCE RISK TOTAL MORTALITY BY REDUCING CORONARY DEATH,REDUCE NONFATAL MI &
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 14 of 62
EXCLUSI VI TY I NDI CATI ON
I-391 ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT
UNDERGO ESOPHAGECTOMY
I-392 TX OF PED PATIENTS W/PH+ CHRONIC PHASE CML DISEASE RECUR AFTER STEM CELL TRNSPLT
OR RESIST TO INTERFERON ALPHA THERAPY.NO CONTROLLED TRIALS DEMONSTRATING A
CLINICAL BENEFIT SUCH AS IMPROVE IN DISEASE RELATED SX OR INCREASED SURVIVAL
I-393 CHRONIC BACTERIAL PROSTATITIS
I-394 USE IN PATIENTS WITH CORONARY HEART DISEASE TO REDUCE THE RISK OF UNDERGOING
CORONARY REVASCULARIZATION PROCEDURES
I-395 TO IMPROVE PHYSICAL FUNCTION
I-396 EXPANDED INDICATION TO INCLUDE THE ASSESSMENT OF VENTRICULAR FUNCTION IN SUBJECTS
I-397
BEING EVALUATED FOR HEART DISEASE AND/OR VENTRICULAR FUNCTION
EXTENDED PROPHYLAXIS IN PATIENTS UNDERGOING HIP FRACTURE SURGERY
I-398 IDIOPATHIC SHORT STATURE
I-399 TREATMENT OF CANDIDEMIA AND THE FOLLOWING CANDIDA INFECTIONS: INTRA-ABDOMINAL
I-400
ABSCESSES, PERITONITIS AND PLEURAL SPACE INFECTIONS
USE OF OLANZAPINE IN COMBINATION WITH LITHIUM OR VALPROATE FOR THE TREATMENT OF
ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER
I-401 LONGER-TERM EFFICACY OF ARIPIPRAZOLE IN THE TREATMENT OF SCHIZOPHRENIA
I-402 DIABETIC FOOT INFECTIONS WITHOUT CONCOMITANT OSTEOMYELITIS
I-403 USE OF VALTREX IN COMBINATION WITH SAFER SEX PRACTICES FOR THE REDUCTION OF THE
RISK OF TRANSMISSION OF GENITAL HERPES DURING SUPPRESIVE THERAPY OF THE SOURCE
PARTNER IN A HETEROSEXUAL COUPLE
I-404 MAINTENANCE TREATMENT OF BIPOLAR I DISORDER TO DELAY THE TIME TO OCCURRENCE OF
MOOD EPISODES (DEPRESSION, MANIA, HYPOMANIA, MIXED EPISODES) IN PATIENTS TREATED
FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
I-405 TREATMENT OF PREMENSTRUAL DYSPHORIC DISORDER (PMDD) USING AN INTERMITTENT DOSING
REGIMEN
I-406
I-407
PREVENTION OF CYTOMEGALOVIRUS DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS
TRANSPLANT PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV
SERONEGATIVE)
IMPROVE SURVIVAL OF STABLE PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
(EJECTION FRACTION<=40%) AND CLINICAL EVIDENCE OF CONGESTIVE HEART FAILURE AFTER
AN ACUTE MYOCARDIAL INFARCTION
I-408 STIMULATION OF PANCREATIC SECRETIONS TO FACILITATE THE INDENTIFICATION OF THE
AMPULLA OF VATER AND ACCESSORY PAPILLA DURING ENDOSCOPIC RETROGRADE CHOLANGIO-
I-409
PANCREATOGRAPHY (ERCP)
ESOPHAGEAL CANDIDIASIS
I-410 USE OF ADVAIR DISKUS 250/50 FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
ASSOCIATED WITH CHRONIC BRONCHITIS
I-411 EXPANDED INDICATION FOR USE IN COMBINATION WITH ANTIDIABETIC DRUGS IN THE
THIAZOLIDINEDIONE CLASS
I-412 MONOTHERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES
ASSOCIATED WITH BIPOLAR I DISORDER
I-413 ADJUNCTIVE THERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES
ASSOCIATED WITH BIPOLAR I DISORDER
I-414 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM
(PE) IN MEDICAL PATIENTS WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS DUE TO
SEVERELY RESTRICTED MOBILITY DURING ACUTE ILLNESS
I-415 SEVERE HYPERTENSION WHEN THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL
EXCEEDS THE RISK OF INITIATING COMBINATION THERAPY
I-416 THE USE OF CIPRO XR FOR COMPLICATED URINARY TRACT INFECTIONS AND ACUTE
UNCOMPLICATED PYELONEPHRITIS
I-417 USE IN THE LONG TERM TREATMENT OF BIPOLAR I DISORDER
I-418 ADJUNCTIVE THERAPY W/ MOOD STABILIZERS (LITHIUM OR DIVALPROEX) IN THE TREATMENT OF
ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDERS
I-419 MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I
DISORDER
I-420 TOPICAL TREATMENT OF CLINICALLY TYPICAL, NONHYPERKERATOTIC, NONHYPERTROPHIC
ACTINIC KERATOSES ON THE FACE OR SCALP IN IMMUNOCOMPETENT ADULTS
I-421 TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND PYELONEPHRITIS DUE TO E.COLI
I-422
FOR PED PATIENTS (1-17) NOT AS FIRST CHOICE
INDICATED FOR THE IN-HOSPITAL SHORT-TERM (UP TO 4 HOURS) REDUCTION IN BLOOD
PRESSURE IN PEDIATRIC PATIENTS
I-423 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
I-424 MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH MODERATE TO SEVERE
CHRONIC RENAL INSUFFICIENCY NOT YET ON DIALYSIS
I-425 FLOXATIN IN COMBINATION WITH INFUSIONAL 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV)
FOR THE TREATMENT OF PATIENTS PREVIOUSLY UNTREATED FOR ADVANCED COLORECTAL CANCER
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 15 of 62
EXCLUSI VI TY I NDI CATI ON
I-426 TREATMENT OF ACUTE PULMONARY EMBOLISM WHEN ADMINISTERED IN CONJUNCTION WITH
WARFARIN SODIUM
I-427 TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITHOUT PULMONARY EMBOLISM WHEN
ADMINISTERED IN CONJUNCTION WITH WARFARIN SODIUM
I-428 FOR USE IN COMBINATION WITH PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS
WITH METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR ANTHRACYCLINE CONTAINING
ADJUVANT CHEMOTHERAPY UNLESS ANTHRACYCLINES WERE CLINICALLY CONTRAINDICATED
I-429 FOR USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH ANDROGEN
I-430
INDEPENDENT (HORMONE REFRACTORY) METASTATIC PROSTATE CANCER
FOR USE IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN ADULTS
I-431 NOSOCOMIAL PNEUMONIA AND COMMUNITY-ACQUIRED PNEUMONIA CAUSED BY STREPTOCOCCUS
PNEUMONIAE INDICATION EXPANDED TO INCLUDE MULTI-DRUG RESISTANT STRAINS
I-432 TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA CAUSED BY MULTI-DRUG RESISTANT
STREPTOCOCCUS PNEUMONIAE
I-433
I-434
TREATMENT OF BIOPSY-CONFIRMED, PRIMARY SUPERFICIAL BASAL CELL CARCINOMA IN
IMMUNOCOMPETENT ADULTS, WITH A MAXIMUM TUMOR DIAMETER OF 2.0CM, LOCATED ON THE
TRUNK (EXCLUDING ANOGENITAL SKIN), NECK, OR EXTREMITIES (EXCLUDING HANDS AND FEET)
PREVENTION OF CARDIOVASCULAR DISEASE IN ADULT PATIENTS WITHOUT CLINICALLY EVIDENT
HEART DISEASE, BUT WITH MULTIPLE RISK FACTORS FOR CORONARY HEART DISEASE TO REDUCE
RISK OF MI AND RISK FOR REVASCULARIZATION PROCEDURES AND ANGINA
I-435 CHRONIC IDIOPATHIC CONSTIPATION
I-436 FOR USE IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE FOR THE ADJUVANT
TREATMENT OF PATIENTS WITH OPERABLE NODE-POSITIVE BREAST CANCER
I-437 TREATMENT OF ACUTE MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR DISORDER
I-438
I-439
EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE, NEUTROPENIC PATIENTS
USED TO TREAT ADULTS WITH GROWTH HORMONE DEFICIENCY
I-440 FOR THE REPLACEMENT OF ENDOGENOUS GROWTH HORMONE IN ADULTS WITH GROWTH HORMONE
DEFICIENCY
I-441 USE COMBINATION WITH INFUSIONAL 5-FU/LV FOR ADJUVANT TREATMENT STAGE III COLON
CANCER PTS WHO HAVE UNDERGONE COMPLETE RESECTION PRIMARY TUMOR-BASED ON
IMPROVEMENT IN DISEASE FREE SURVIVAL, NO DEMONSTRATED BENEFIT OVERALL SURVIVAL
AFTER 4YRS
I-442 USED FOR CANDIDEMIA IN NONNEUTROPENIC PATIENTS AND THE FOLLOWING CANDIDA
I-443
INFECTIONS: DISSEMINATED INFECTIONS IN SKIN & INFECTIONS IN ABDOMEN, KIDNEY,
BLADDER WALL, AND WOUNDS
TREATMENT OF NASAL POLYPS IN PATIENTS 18 YEARS OF AGE AND OLDER
I-444 USE OF PROTONIX IV FOR INJECTION AS STAND ALONE THERAPY FOR THE SHORT-TERM
TREATMENT OF PATIENTS HAVING GASTROESOPHAGEAL REFLUX (GERD) WITH A HISTORY OF
EROSIVE ESOPHAGITIS
I-445 TO IMPROVE (COMPARED TO 4.25% DEXTROSE) LONG-DWELL ULTRAFILTRATION AND CLEARANCE
OF CREATININE AND UREA NITROGEN IN PATIENTS WITH HIGH AVERAGE OR GREATER TRANSPORT
I-446
CHARACTERISTICS, AS DEFINED USING THE PERITONEAL EQUILIBRATION TEST (PET)
EXTENDED ADJUVANT TREATMENT OF EARLY BREAST CANCER IN POSTMENOPAUSAL WOMEN WHO
HAVE RECEIVED 5 YRS ADJUVANT TAMOXIFEN THERAPY-EFFECTIVENESS BASED ON AN ANALYSIS
OF DISEASE FREE SURVIVAL IN PATIENTS TREATED FOR A MEDIAN 24 MONTHS
I-447
I-448
USE OF COPEGUS (RIBAVIRIN) FOR TREATMENT OF CHRONIC HEPATITIS C IN ADULT PATIENTS
COINFECTED WITH HIV IN COMBINATION WITH PEGASYS (PEGINTERFERON ALFA-2A)
TREATMENT OF HEART FAILURE (NYHA CLASS II-IV AND EJECTION FRACTION <=40%) TO
REDUCE THE RISK OF DEATH FROM CARDIOVASCULAR CAUSES AND TO REDUCE HOSPITALIZATIONS
FOR HEART FAILURE
I-449 TO IMPROVE WAKEFULNESS IN TWO NEW PATIENT POPULATIONS WITH EXCESSIVE SLEEPINESS:
THOSE WITH OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME AND THOSE WITH SHIFT WORK
SLEEP DISORDER
I-450 TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED HIGH GRADE GLIOMAS CONCOMITANTLY WITH
RADIOTHERAPY AND THEN AS ADJUVANT TREATMENT
I-451 MANAGEMENT OF ENDOMETRIOSIS ASSOCIATED PAIN
I-452 EXPANDED INDICATION TO INCLUDE TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE
RECEIVED AT LEAST 1 PRIOR THERAPY
I-453
I-454
USE IN COMBINATION WITH A SULFONYLUREA PLUS METFORMIN WHEN DIET, EXERCISE AND BOTH
AGENTS DO NOT RESULT IN ADEQUATE GLYCEMIC CONTROL (TRIPLE THERAPY)
MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE CHRON'S DISEASE INVOLVING
I-455
THE ILEUM AND/OR THE ASCENDING COLON FOR UP TO 3 MONTHS
MODIFIED HEART FAILURE INDICATION TO INCLUDE TREATMENT OF HEART FAILURE IN
I-456
PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION (NYHA CLASS II-IV; EJECTION
FRACTION LESS THAN OR EQUAL TO 40%
TO REDUCE CARDIOVASCULAR DEATH AND TO REDUCE HEART FAILURE HOSPITALIZATIONS.
INCLUDES ADDITIONAL INFORMATION ON THE ADDED EFFECT ON THESE OUTCOMES WHEN USED
WITH AN ACE INHIBITOR
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 16 of 62
EXCLUSI VI TY I NDI CATI ON
I-457 TREATMENT OF PATIENTS UNDERGOING ABDOMINAL SUREGERY WHO ARE AT RISK FOR
THROMBOEMBOLIC COMPLIATIONS
I-458
I-459
USE OF BIVALIRUDIN FOR INJECTION WITH PROVISIONAL USE OF GLYCOPROTEIN IIB/IIA
INHIBITOR (GPI) AS LISTED IN THE CLINICAL TRIALS REPLACE-2 SECTION FOR USE AS AN
ANTICOAGULANT IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)
NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE (NDD-CKD) PATIENTS RECEIVING OR NOT
RECEIVING AN ERYTHROPOIETIN
I-460 TREATMENT OF DIARRHEA CAUSED BY CRYPTOSPORIDIUM PARVUM IN NON-HIV INFECTED
PATIENTS 12 YEARS OF AGE AND OLDER
I-461 USE AS A SINGLE AGENT FOR ADJUVANT TREATMENT IN PATIENTS WITH DUKES' C COLON
CANCER WHO HAVE UNDERGONE COMPLETE RESECTION OF THE PRIMARY TUMOR WHEN TREATMENT
WITH FLUOROPYRIMIDINE THERAPY ALONE IS PREFERRED
I-462 LONG TERM TREATMENT OF IDIOPATHIC SHORT STATURE
I-463 TREATMENT OF PATIENTS POST MYOCARDIAL INFARCTION
I-464 TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME
I-465 PERENNIAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND
OLDER
I-466 FOR RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS
I-467 USE OF TOPIRAMATE AS INITIAL MONOTHERAPY IN PATIENTS 10 YEARS OF AGE AND OLDER
WITH PARTIAL ONSET OR PRIMARY GENERALIZED TONIC CLONIC SEIZURES
I-468 USE IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE TO REDUSE THE RISK OF
CARDIOVASCULAR MORTALITY OR NON-FATAL MYOCARDIAL INFECTION
I-469 RELIEF OF THE SIGNS AND SYMPTOMS OF PAUCIARTICULAR OR POLYARTICULAR COURSE
JUVENILE RHEUMATOID ARTHRITIS IN PATIENTS 2 YEARS OF AGE AND OLDER
I-470 DIABETIC PERIPHERAL NEUROPATHIC PAIN
I-471 INDICATED TO REDUCE THE RISK OF MYOCARDIAL INFARCTION AND STROKE IN PATIENTS WITH
TYPE 2 DIABETES AND WITHOUT CLINICALLY EVIDENT CORONARY HEART DISEASE BUT WITH
MULTIPLE RISK FACTORS FOR CORONARY HEART DISEASE
I-472 USE IN PATIENTS WITH ANGIOGRAPHICALLY DOCUMENTED CORONARY ARTERY DISEASE
I-473 USE IN COMBINATION WITH GEMCITABINE FOR THE FIRST LINE TREATMENT OF PATIENTS WITH
LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC CANCER
I-474 TREATMENT OF IRON DEFICIENCY ANEMIA IN PERITONEAL DIALYSIS DEPENDANT CHRONIC
KIDNEY DISEASE IN PATIENTS RECIEVING AN ERYTHROPOIETIN
I-475 PREVENTION OF NAUSEA AND VOMITTING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF
MODERATELY EMETOGENIC CANCER CHEMOTHERAPY
I-476 TREATMENT OF DIABETIC FOOT INFECTIONS WITHOUT OSTEOMYELITIS
I-477 TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY METHICILLIN
SUSCEPTIBLE STAPHYLOCOCCUS AUREUS, ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR
ENTEROBACTER CLOACAE
I-478 FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN CHILDREN
WITH EPILEPSY AGED 2-4 YEARS
I-479 TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS CAUSED BY E.COLI, B. FRAGILIS,
S.ANGINOSUS, S.CONSTELLATUS, E. FAECALIS, P. MIRABILIS, C. PERFRINGENS, B.
THETAIOTAOMICRON OR PEPTOSTREPTOCOCCUS SPECIES
I-480 PROPHYLAXIS OF INFLUENZA FOR PATIENTS BETWEEN 1-12 YEARS OF AGE
I-481 INDICATED FOR THE ADJUVANT TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR
POSITIVE EARLY BREAST CANCER
I-482 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH
OR WITHOUT PSYCHOTIC FEATURES
I-483 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
I-484 FOR THE RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS
I-485 TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS
WHO HAVE UNDERGONE CATARACT EXTRACTION
I-486
I-487
ANGIOMAX IS INDICATED FOR PATIENTS WITH, OR AT RISK OF, HIT/HITTS UNDERGOING PCI
INDICATED FOR THE RELIEF OF THE INFAMMATORY AND PRURITIC MANIFESTATIONS OF
CORTICOSTEROID RESPONSIVE DERMATOSES IN PATIENTS 12 YRS OF AGE OR OLDER
I-488 MAINTENANCE THERAPY IN BIPOLAR I DISORDER
I-489 FOR USE IN PEDIATRIC PATIENTS WITH TYPE I DIABETES
I-490 FOR USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE TREATMENT OF
PATIENTS WITH ADVANCED GASTRIC ADENOCARCINOMA, INCLUDING ADENOCARCINOMA OF
GASTROESOPHAGEAL JUNCTION, WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY FOR ADVANCED
DISEASE
I-491 INFLUENZA PROPHYLAXIS
I-492 MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC OR MIXED EPISODES IN BIPOLAR I
I-493
DISORDER, WITH OR WITHOUT PSYCHOTIC FEATURES
ADMINISTERED IN COMBINATION WITH FENOFIBRATE, AS ADJUNCTIVE THERAPY TO DIET FOR
THE REDUCTION OF ELEVATED TOTAL-C, LDL-C, APO B, AND NON-HDL-C IN PATIENTS WITH
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 17 of 62
EXCLUSI VI TY I NDI CATI ON
MIXED HYPERLIPIDEMIA
I-494 CLINICAL DATA IN SUPPORT OF AVANDAMET AS AN ADJUNCT TO DIET AND EXERCISE TO
IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT
WITH DUAL ROSIGLITAZONE AND METFORMIN THERAPY IS APPROPRIATE
I-495 ADJUVANT TX OF POSTMENOPAUSAL WOMEN WITH ESTROGEN-RECEPTOR POSITIVE EARLY BREAST
CANCER WHO HAVE RECEIVED 2 TO 3 YRS OF TAMOXIFEN AND ARE SWITCHED TO AROMASIN FOR
COMPLETION OF A TOTAL OF 5 CONSECUTIVE YRS OF ADJUVANT HORMONAL THERAPY
I-496 LONG TERM TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME IN PATIENTS
WHO HAVE OPEN EPIPHYSES
I-497 PREVENTION OF SEASONAL MAJOR DEPRESSIVE EPISODES IN PATIENTS WITH SEASONAL
AFFECTIVE DISORDER
I-498 PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
I-499 USE OF GEMZAR IN COMBINATION WITH CARBOPLATIN FOR THE TREATMENT OF PATIENTS WITH
ADVANCED OVARIAN CANCER THAT HAS RELAPSED AT LEAST 6 MONTHS AFTER COMPLETION OF
PLATINUM-BASED THERAPY
I-500 FOR USE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF MULTIPLE MYELOMA
PATIENTS WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
I-501 TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN IMMUNOCOMPETANT PATIENTS
WITH A SINGLE DOSE OF FAMCICLOVIR 1500 MG.
I-502 FOR PTS WITH ST-SEGMENT ELEVATION ACUTE MYOCARDIAL INFARCTION, PLAVIX TO REDUCE
RATE OF DEATH FROM ANY CAUSE AND THE RATE OF A COMBINED ENDPOINT OF DEATH,
REINFARCTION OR STROKE. NOT KNOWN TO PERTAIN TO PTS WHO RECEIVE PRIMARY
ANGIOPLASTY
I-503 TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER
I-504 TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME
I-505 TREATMENT OF STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA), INCLUDING
THOSE WITH RIGHT SIDED INFECTIVE ENDOCARDITIS, CAUSED BY METHICILLIN-SUSCEPTIBLE
AND METHICILLIN-RESISTANT ISOLATES
I-506 ADJUNCTIVE THERAPY OF MYOCLONIC SEIZURES IN ADULTS AND ADOLESCENTS AGE 12 AND OVER
WITH JUVENILE MYOCLONIC EPILEPSY
I-507 ADJUNCT TO DIET TO REDUCE TOTAL-C, LDL-C AND APO B LEVELS IN ADOLESCENT BOYS AND
GIRLS WHO ARE AT LEAST ONE YEAR POST-MENARCHE, 10-16 YEARS OF AGE, WITH
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
I-508 PREMENSTRUAL DYSPHONIC DISORDER
I-509 TREATMENT OF IRRATABILITY ASSOCIATED WITH AUTISTIC DISORDER
I-510
I-511
I-512
I-513
I-514
I-515
ADULT DERMAFIBROSARCOMA PROTUBERANS (DFSP)
ADULT MYELODYSPLASTIC SYNDROME/MYELOPROLIFERATIVE DISEASES (MDS/MDP)
ADULT PH+ ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) MONOTHERAPY
ADULT AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM)
ADULT HYPEREOSINOPHILIC SYNDROME/CHRONIC EOSINOPHILIC LEUKEMIA (HES/CEL)
PROPHYLAXIS OF SURGICAL SITE INFECTION FOLLOWING ELECTIVE COLORECTAL SURGERY
I-516 PRIMARY GENERALIZED TONIC CLONIC SEIZURES IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS
OF AGE AND OLDER
I-517
I-518
I-519
TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEG SYNDROME (RLS)
TREATMENT OF SHORT STATURE OR GROWTH FAILURE IN CHILDREN WITH SHOX (SHORT STATURE
HOMEOBOX CONTAINING GENE) DEFICIENCY WHOSE EPIPHYSES ARE NOT CLOSED
USE OF TAXOTERE (DOCETAXEL) INJECTION CONCENTRATE IN COMBINATION WITH CISPLATIN
AND FLUOROURACIL FOR THE INDUCTION OF PATIENTS WITH INOPERABLE LOCALLY ADVANCED
I-520
SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)
USE OF EXENATIDE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE USING A
THIAZOLIDINEDIONE ALONE OR IN COMBINATION WITH METFORMIN BUT HAVE NOT ACHIEVED
I-521
ADEQUATE GLYCEMIC CONTROL
TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 YEAR
PRIOR THERAPY
I-522 TREATMENT OF MODERATE ACNE VULGARIS IN WOMEN AT LEAST 14 YRS OF AGE, WHO HAVE NO
KNOWN CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY, AND HAVE ACHIEVED MENARCHE,
IF THE PATIENT DESIRES AN ORAL CONTRACEPTIVE FOR BIRTH CONTROL.
I-523 USE IN ADULT PATIENTS WITH CLINICALLY EVIDENT CORONARY HEART DISEASE TO REDUCE THE
RISK OF NONFATAL MYOCARDIAL INFARCTION, FATAL AND NONFATAL STROKE, ANGINA,
REVASCULARIZATION PROCEDURES AND HOSPITALIZATION FOR CONGESTIVE HEART FAILURE
I-524
I-525
I-526
GENERALIZED ANXIETY DISORDER (GAD)
USE OF 0.5MG/0.1MG FOR PREVENTION OF POST-MENOPAUSAL OSTEOPOROSIS
TREATMENT OF HYPONATREMIA IN HOSPITALIZED PATIENTS
I-527 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER WITH IDIOPATHIC GENERALIZED
EPILEPSY
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 18 of 62
EXCLUSI VI TY I NDI CATI ON
I-528 TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE,
SYMPTOMS OF VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH MENOPAUSE
I-529 TREATMENT OF DEMENTIA OF THE ALZHEIMER'S TYPE IN PATIENTS WITH SEVERE ALZHEIMER'S
DISEASE
I-530 PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION IN PATIENTS 15 YEARS OF AGE AND
OLDER
I-531 MAINTENANCE TREATMENT OF SCHIZOPHRENIA
I-532 TREATMENT OF BACTERIAL VAGINOSIS IN NON-PREGNANT FEMALES
I-533
I-534
ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI)
EXTENDED TREATMENT OF SYMPTOMATIC VENOUS THROMBOEMBOLISM (VTE) AND/OR PULMONARY
EMBOLISM TO REDUCE THE RECCURENCE OF VTE IN PATIENTS WITH CANCER
I-535 MANAGEMENT OF FIBROMYALGIA
I-536 FOR THE TREATMENT OF SHORT STATURE IN CHILDREN WITH NOONAN SYNDROME
I-537 LONG TERM TREATMENT OF PANIC DISORDER
I-538 SHORT TERM TREATMENT OF PANIC DISORDER
I-539 REDUCTION IN RISK OF INVASIVE BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH
OSTEOPOROSIS OR AT HIGH RISK FOR INVASIVE BREAST CANCER
I-540 TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGES 13-17
I-541 TREATMENT OF BIPOLAR I DISORDER IN CHILDREN AGES 10-12 AND ADOLESCENTS AGES 13-17
I-542 EXPANSION OF PATIENT POPULATION FOR HEAD AND NECK CANCER FROM "INOPERABLE"
PATIENTS TO ALL PATIENTS
I-543 USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE INDUCTION TREATMENT OF
I-544
PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
(SCCHN)
ADJUNCTIVE THERAPY OF MYOCLONIC SEIZURES IN ADULTS AND ADOLESCENTS AGE 16 AND OVER
WITH JUVENILE MYOCLONIC EPILEPSY
I-545 ADJUNCTIVE TREATMENT TO TREAT PATIENTS WITH MAJOR DEPRESSIVE DISORDER
I-546 TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA
I-547 ADJUNCTIVE THERAPY TO DIET TO SLOW THE PROGRESSION OF ARTHEROSCLEROSIS IN ADULT
PATIENTS AS PART OF A TREATMENT STRATEGY TO LOWER TOTAL-C AND LDL-C TO TARGET
LEVELS
I-548 SEASONAL ALLERGIC RHINITIS IN PATIENTS 6 THROUGH LESS THAN 12 YEARS OF AGE
I-549 USE OF AVALIDE TABLETS AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED
MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD PRESSURE GOALS
I-550 TREATMENT OF HYPERTENSION IN PEDIATRIC PATIENTS 6-16 YEARS OF AGE
I-551 TREATMENT OF SHORT STATURE IN CHILDREN WITH TURNER'S SYNDROME
I-552 ADJUNCTIVE TREATMENT FOR RADIOIODINE ABLATION OF THYROID TISSUE REMNANTS IN
PATIENTS WHO HAVE UNDERGONE THYROIDECTOMY FOR WELL-DIFFERENTIATED THYROID CANCER
AND WHO DO NOT HAVE EVIDENCE OF METASTATIC THYROID CANCER
I-553 FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS
WITH TYPE 2 DIABETES MELLITUS
I-554 TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA
PERITONIS AND ABSCESSES
I-555 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN
PEDIATRIC PATIENTS AGED 10-17 YEARS
I-556 PREVENTION OF POST OPERATIVE NAUSEA AND VOMITING FOR UP TO 24 HOURS FOLLOWING
SURGERY
I-557
I-558
USE OF AMITIZA (LUBIPROSTONE) 8 MCG TWICE DAILY FOR TREATMENT OF IRRITABLE BOWEL
SYNDROME WITH CONSTIPATION IN WOMEN GREATER THAN OR EQUAL TO 18 YEARS OLD
MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION AND REDUCING EXACERATIONS IN PATIENTS
WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND
EMPHYSEMA
I-559 ADJUNCTIVE THERAPY ADDED TO LITHIUM OR VALPROATE IN SHORT TERM TREATMENT OF
I-560
BIPOLAR DISORDER, MANIC OR MIXED
MAINTENANCE TREATMENT FOR BIPOLAR I DISORDER, AS ADJUNCTIVE THERAPY TO LITHIUM OR
DIVALPROEX
I-561 LONG-TERM TREATMENT OF SOCIAL ANXIETY DISORDER
I-562 MAINTENANCE TREATMENT OF ATTENTION-DEFICIT DISORDER (ADHD) IN CHILDREN AND
ADOLESCENTS
I-563 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SIEZURES
IN ADULTS AND CHILDREN 16 YEARS OF AGE AND OLDER WITH IDIOPATHIC GENERALIZED
EPILEPSY
I-564 TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
I-565 USE OF DUTASTERIDE IN COMBINATION WITH TAMSULOSIN FOR THE TREATMENT OF SYMPTOMATIC
I-566
BENIGN PROSTATIC HYPERPLASIA (BPH)
MANAGEMENT OF FIBROMYALGIA
I-567 INITIAL THERAPY IN PATIENTS LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 19 of 62
EXCLUSI VI TY I NDI CATI ON
PRESSURE GOALS
I-568 USE OF APTIVUS, CO-ADMINISTERED W/RITONAVIR, FOR COMBINATION ANTIRETROVIRAL
TREATMENT OF HIV-1 INFECTED PED (AGE 2-18 YRS) PATIENTS WHO ARE TREATMENT-
EXPERIENCED AND INFECTED W/HIV-1 STRAINS RESISTANT TO MORE THAN ONE PROTEASE
INHIBITOR
I-569 TREATMENT OF CHRONIC HEPATITIS B
I-570 TREATMENT OF CHICKEN POX IN IMMUNOCOMPETENT PEDIATRIC PATIENTS 2 TO <18 YEARS OF
AGE
I-571 NON-SMALL CELL LUNG CANCER IN COMBINATION WITH CISPLATIN AND AS SINGLE AGENT FOR
NONSQAUMOUS NON-SMALL CELL LUNG CANCER
I-572 TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA) WITH
NO CATCH-UP BY AGE 2-4 YRS.
I-573 TO TREAT PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDICKSON TYPE III
HYPERLIPOPROTEINEMIA) AS AN ADJUNCT TO DIET
I-574 MONOTHERAPY IN THE TREATMENT OF BIPOLAR DEPRESSION
I-575 MONOTHERAPY IN THE TREATMENT OF BIPOLAR MANIA
I-576 ADJUNCTIVE THERAPY IN THE TREATMENT OF BIPOLAR MANIA
I-577 SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER
PROCUDURES
I-578 EXPANSION OF INDICATION TO INCLUDE TREATMENT OF HIV IN TREATMENT NAIVE ADULTS
I-579 TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA, A SYMPTOM OF VULVAR AND VAGINAL
ATROPHY, DUE TO MENOPAUSE AND NEW TWICE WEEKLY DOSING REGIMEN FOR THIS INDICATION
I-580 INDOLENT B-CELL NON-HODGKINS LYMPHOMA (NHL) THAT HAS PROGRESSED DURING OR WITHIN
SIX MONTHS OF TREATMENT WITH RITUXIMAB OR A RITUXIMAB CONTAINING REGIMEN
I-581 TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
I-582 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
I-583 ADJUVANT TREATMENT OF ADULT PATIENTS FOLLOWING COMPLETE GROSS RESECTION OF KIT
(CD117) POSITIVE GASTOINTESTINAL STROMAL TUMORS (GIST)
I-584 TREATMENT AND PREVENTION OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN PATIENTS
EXPECTED TO BE ON GLUCOCORTICOIDS FOR AT LEAST 12 MONTHS
I-585 TREATMENT OF SHORT STATURE IN PEDIATRIC PATIENTS SMALL FOR GESTATIONAL AGE WHO DO
NOT MANIFEST CATCH UP GROWTH BY AGE 2 TO 4 YEARS
I-586 COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
I-587 ADDITIONAL PATHOGENS TO COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS INDICATION
I-588 ADDITIONAL PATHOGENS TO COMPLICATED INTRA-ABDOMINAL INFECTIONS INDICATION
I-589 TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH OLANZAPINE
I-590 ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN
COMBINATION WITH OLANZAPINE)
I-591 TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH FLUOXETINE
I-592 ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN
COMBINATION WITH FLUOXETINE)
I-593 TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD)
I-594 INDICATION EXPANDED TO INCLUDE PATIENTS WHO HAVE EXPERIENCED A FIRST CLINICAL
EPISODE AND HAVE MRI FEATURES CONSISTENT WITH MULTIPLE SCLEROSIS
I-595 PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
I-596 USE AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE FOR THE MAINTENANCE TREATMENT
OF BIPOLAR I DISORDER
I-597 MONOTHERAPY FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER
I-598 TREATMENT OF PULMONARY ARTERIAL HYPERTENSION INDICATION EXPANDED TO INCLUDE DELAY
IN CLINICAL WORSENING
I-599 PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC
KIDNEY DISEASE (CKD) STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS
I-600 FOR USE AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED MULTIPLE DRUGS TO
ACHIEVE THEIR BLOOD PRESSURE GOALS
I-601 MAINTENANCE TREATMENT IN PATIENTS WITH ADVANCED OR METASTATIC NONSQUAMOUS NON-
SMALL CELL LUNG CANCER WHOSE DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES OF
PLATINUM-BASED FIRST LINE CHEMOTHERAPY
I-602 TREATMENT OF MEN AND WOMEN WITH OSTEOPOROSIS ASSOCIATED WITH SUSTAINED SYSTEMIC
GLUCOCORTICOID THERAPY AT HIGH RISK FOR FRACTURE
I-603 GOUT FLARES
I-604 PREVENTION OF CMV DISEASE IN KIDNEY AND HEART TRANSPLANT PATIENTS 4 MONTHS TO 16
YEARS AT HIGH RISK
I-605 ADJUNCT TO MOOD STABILIZERS AND/OR ANTIDEPRESSANTS FOR SCHIZOAFFECTIVE DISORDER
I-606 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY
I-607 INDICATION EXPANDED TO INCLUDE TREATMENT OF PULMONARY ARTENAL HYPERTENSION (WHO
GROUP I) IN PATIENTS WITH CLASS II SYMPTOMS
I-608 REDUCE LDL-C LEVELS IN BOYS AND POSTMENARCHAL GIRLS, 10 TO 17 YEARS OF AGE, WITH
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 20 of 62
EXCLUSI VI TY I NDI CATI ON
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA AS MONOTHERAPY OR IN COMBINATION WITH A
I-610
STATIN AFTER FAILING AN ADEQUATE TRIAL OF DIET THERAPY
TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR WOMEN WHO CHOOSE TO USE INTRAUTERINE
CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION
I-611 TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND
POSTMENARCHAL GIRLS, AGES 10 TO 17 YEARS, WITH A RECOMMENDATION DOSING RANGE OF 5
TO 20 MG ONCE DAILY
I-612 MICARDIS 80 MG FOR REDUCTION OF THE RISK OF MYOCARDIAL INFARCTION, STROKE, OR
DEATH FROM CARDIOVASCULAR CAUSES IN PATIENTS 55 YEARS OF AGE OR OLDER AT HIGH RISK
OF DEVELOPING MAJOR CARDIOVASCULAR EVENTS WHO ARE UNABLE TO TAKE ACE INHIBITORS
I-613 MILD TO MODERATE ATOPIC DERMATITIS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 18
YEARS OF AGE
I-614 SHORT TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD IN PEDIATRIC
PATIENTS AGES FIVE YEARS AND OLDER
I-615 MAINTENANCE TREATMENT OF BIPOLAR DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE
I-616 TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS
AGES 6-17 YEARS OF AGE
I-617
I-618
I-619
MAINTENANCE OF GENERALIZED ANXIETY DISORDER (GAD)
ADJUNCTIVE THERAPY IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
INTRAVENOUS CONTRAST ENHANCED COMPUTER TOMOGRAPHY OF THE HEAD AND BODY
I-620 FOR USE IN COMBINATION WITH LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN
WITH HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER THAT OVEREXPRESSES THE
HER2 RECEPTOR FOR WHOM HORMONAL THERAPY IS INDICATED
I-621
I-622
PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE, BASED ON THE RESULTS OF
JUSTIFICATION FOR THE USE OF STATINS IN PRIMARY PREVENTION; AN INTERVENTION TRIAL
EVALUATING ROSUVASTATIN (JUPITER)
ADJUNCTIVE THERAPY FOR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS
THIRTEEN YEARS OF AGE AND OLDER
I-623 TREATMENT OF SIGNS AND SYMPTOMS OF ADVANCED IDIOPATHIC PARKINSON'S DISEASE
I-624 MAINTENANCE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL
CELL LUNG CANCER WHOSE DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES OF PLATINUM-
BASED FIRST-LINE CHEMOTHERAPY
I-625 PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY
I-626 RELIEF OF NASAL CONGESTION ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS
AND PEDIATRIC PATENTS 2 YEARS OF AGE AND OLDER
I-627 TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE
I-628
CHRONIC MYELOID LEUKEMIA (PH & CML) IN CHRONIC PHASE.
MAINTENANCE TREATMENT OF SCHIZOPHRENIA IN ADULTS
I-629 ADJUNCTIVE THERAPY WITH EITHER LITHIUM OR VALPROATE FOR THE ACUTE TREATMENT OF
MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
I-630 TREATMENT OF PATIENTS WITH SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) ASSOCIATED
WITH TUBEROUS SCLEROSIS (TS) WHO REQUIRE THERAPEUTIC INTERVENTION BUT ARE NOT
CANDIDATES FOR CURATIVE SURGICAL RESECTION.
I-631 PREVENTION OF RELAPSE TO OPIOID DEPENDENCE FOLLOWING OPIOID DETOXIFICATION
I-632 MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN
I-633 MAINTENANCE TREATMENT OF BIPOLAR I DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE
I-634 TREATMENT OF SEVERE HYPERCALCEMIA IN PATIENTS WITH PRIMARY HYPERPARATHYROIDISM WHO
ARE UNABLE TO UNDERGO PARATHYROIDECTOMY
I-635 ADJUNCTIVE TREATMENT WITH LONG-ACTING ORAL PSYCHOSTIMULANTS FOR THE TREATMENT OF
I-636
ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
TREATMENT OF EXTERNAL GENITAL AND PERIANAL WARTS/CONDYLOMA ACUMINATA IN PATIENTS
12 YEARS OR OLDER
I-637 USE IN COMBINATION CHEMOTHERAPY WITH 5-FLUOROURACIL IN THE PALLIATIVE TREATMENT OF
PATIENTS WITH ADVANCED METASTATIC COLORECTAL CANCER
I-638
I-639
I-640
FOR PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET)
THAT ARE UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC.
TREATMENT OF PROGRESSIVE, WELL-DIFFERENTIATED PANCREATIC NEUROENDOCRINE TUMORS IN
PATIENTS WITH UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC DISEASE
MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
I-641
I-642
I-643
TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA (BPH)
TREATMENT OF ERECTILE DYSFUNCTION (ED) AND THE SIGNS AND SYMPTOMS OF BENIGN
PROSTATIC HYPERPLASIA (BPH)
REDUCE THE RISK OF STROKE AND SYSTEMIC EMBOLISM IN PATIENTS WITH NONVALVULAR
ATRIAL FIBRILLATION.
I-644 MONOTHERAPY IN PATIENTS 13 YEARS OF AGE AND OLDER WITH PARTIAL SEIZURES WHO ARE
I-645
RECEIVING THERAPY WITH A SINGLE ANTIEPILEPTIC DRUG (AED)
MAINTENANCE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN ADULTS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 21 of 62
EXCLUSI VI TY I NDI CATI ON
I-646 SIGNS AND SYMPTOMS OF ADVANCED PARKINSON'S DISEASE (APD)
I-647 SIGNS AND SYMPTOMS OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)
I-648 TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO
CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION
I-649 TREATMENT OF PATIENTS WITH ADVANCED SOFT TISSUE SARCOMA (STS) WHO HAVE RECEIVED
PRIOR CHEMOTHERAPY
I-650 TREATMENT OF ADULTS WITH RENAL ANGIOMYOLIPOMA AND TUBEROUS SCLEROSIS COMPLEX
(TSC), NOT REQUIRING IMMEDIATE SURGERY
I-651 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH SPINAL CORD INJURY
I-652 MANAGEMENT OF POSTHERPETIC NEURALGIA
I-653 TREATMENT OF ENDOGENOUS ANTERIOR UVEITIS
I-654 MAGNETIC RESONANCE ANGIOGRAPHY (MRA) TO EVALUATE ADULTS WITH KNOWN OR SUSPECTED
RENAL OR AORTO-ILIO-FEMORAL OCCLUSIVE VASCULAR DISEASE
I-655 TREATMENT OF POSTMENOPAUSAL WOMEN WITH ADVANCED HORMONE RECEPTOR-POSITIVE,HER2-
NEGATIVE BREAST CANCER (ADVANCED HR+BC) IN COMBINATION WITH EXEMESTANE, AFTER
FAILURE OF TREATMENT WITH LETROZOLE OR ANASTROZOLE
I-656 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
(DPN) IN ADULTS WHEN A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC IS NEEDED FOR
AN EXTENDED PERIOD OF TIME
I-657 PLAQUE PSORIASIS OF THE SCALP
I-658 FIRST-LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER,
IN COMBINATION WITH CARBOPLATIN, IN PATIENTS WHO ARE NOT CANDIDATES FOR CURATIVE
SURGERY OR RADIATION THERAPY
I-659 PLAQUE PSORIASIS OF THE BODY
I-660 TREATMENT OF DEEP VEIN THROMBOSIS
I-661 TREATMENT OF PULMONARY EMBOLISM
I-662 REDUCTION IN RISK FOR DEEP VEIN THROMBOSIS AND THE REDUCTION IN RISK FOR PULMONARY
EMBOLISM
I-663 IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER
I-664 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE
INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
I-665 TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS OF AGE AND OLDER WITH
(NTDT)SYNDROMES AND WITH A (LIC) OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY
WEIGHT (MG FE/G DW) AND SERUM FERRITIN GREATER THAN 300MCG/L
I-666 TREATMENT OF PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-
POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ALL) IN COMBINATION WITH CHEMOTHERAPY
I-667 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE OR METASTATIC
GASTROINTESTINAL STROMAL TUMOR (GIST) WHO HAVE BEEN PREVIOUSLY TREATED WITH
IMATINIB MESYLATE AND SUNITINIB MALATE
I-668 PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT
I-669 SCINTIGRAPIC ASSESSMENT OF SYMPATHETIC INNERVATION OF THE MYOCARDIUM BY
MEASUREMENT OF THE HEART TO MEDIASTINUM (H/M) RATIO OF RADIOACTIVITY UPTAKE IN
PATIENTS WITH NYHA CLASS II OR CLASS III HEART FAILURE AND LVEF LESS THAN 35%
I-670 TREATMENT OF OPIOID-INDUCED CONSTIPATION (OIC) IN ADULTS WITH CHRONIC, NON-CANCER
PAIN
I-671 FIRSTLINE TREATMENT OF PATIENTS WITH METASTATIC NON- SMALL CELL LUNG CANCER
(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19
DELETIONS OR EXON 21(L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA- APPROVED
TEST
I-672 USE IN PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED
AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
I-673 TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA/VENTILATOR-ASSOCIATED BACTERIAL
PNEUMONIA (HABP/VABP) CAUSED BY SUSCEPTIBLE ISOLATES OF S. AUREUS (INCL.
METHICILLIN-SUSCEPTIBLE AND -RESISTANT ISOLATES) WHEN ALTERNATIVE TREATMENTS ARE
NOT SUITABLE
I-674 TREATMENT OF PATIENTS WITH DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
(BIPOLAR DEPRESSION) AS MONOTHERAPY AND AS ADJUNCTIVE THERAPY WITH LITHIUM OR
VALPROATE
I-675 MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER
I-676 FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARACINOMA OF THE PANCREAS,
IN COMBINATION WITH GEMCITABINE
I-677 TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE,
DIFFERENTIATED THYROID CARCINOMA (DTC) THAT IS REFRACTORY TO RADIOCACTIVE IODINE
TREATMENT
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 22 of 62
EXCLUSI VI TY MI SCELLANEOUS
M-1 INFORMATION REGARDING SUPERIORITY CLAIM OVER RANITIDINE FOR DAY AND NIGHT
HEARTBURN ADDED TO CLINICAL STUDIES SECTION
M-2 APPROVAL FOR ADDTION TO CLINICAL PHARMACOLOGY SECTION OF THE LABEL REGARDING (1)
IMPROVEMENT IN BONE MINERAL DENSITY IN CHILDHOOD-ONSET ADULT GROWTH HORMONE
M-3
DEFICIENT PATIENTS AND (2) INCREASES IN SERUM ALKALINE PHOSPHATASE
ADDITION OF EFFICACY AND SAFETY INFORMATION IN WHICH FOSAMAX WAS USED
CONCOMITANTLY WITH ESTROGEN ALONE OR WITH ESTROGEN PLUS PROGESTIN
M-4 CHANGES TO PEDIATRIC USE SECTION TO PROVIDE INFORMATION REGARDING SAFETY AND
EFFICACY IN PEDIATRIC PATIENTS AS YOUNG AS 2 YEARS OLD
M-5 INFORMATION REGARDING EFFECTS IN PATIENTS WITH ASTHMA ON CONCOMITANT INHALED
CORTICOSTEROIDS IN CLINICAL PHARMACOLOGY SECTION
M-6 ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH GLUCOPHAGE/GLYBURIDE
COMBINATION ADDED TO CLINICAL PHARMACOLOGY AND DOSING AND ADMINISTRATION
M-7
M-8
M-9
CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS; DOSAGE AND ADMINISTRATION INFORMATION
ADDITIONAL INFORMATION FOR THE USE OF SONATA CAPSULES FOR UP TO 5 WEEKS (35
NIGHTS) OF TREATMENT IN A CONTROLLED TRIAL SETTING
ADDITION TO THE CLINICAL STUDIES SECTION OF THE LABELING OF TEXT AND TWO TABLES
M-10
CONTAINING INFORMATION FOR THE PRESCRIBING PHYSICIAN ON BLOOD PRESSURE, HEART
RATE, AND HEART RATE VARIABILITY
INFORMATION REGARDING MAINTENANCE OF AN ANTIDEPRESSANT EFFECT UP TO 1 YEAR OF
DOSING
M-11 USE FOR LONG-TERM TREATMENT OF POSTTRAUMATIC STRESS DISORDER
M-12 NEW LANGUAGE FOR PEDIATRIC USE
M-13 INFORMATION FROM PEDIATRIC STUDIES ADDED TO CLINICAL PHARMACOLOGY, PRECAUTIONS,
AND DOSAGE AND ADMINISTRATION
M-14 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
M-15 LONGER TERM EFFICACY INFORMATION FOR RISPERIDONE IN THE TREATMENT OF SCHIZOPHRENIA
M-16 CHANGE IN WORDING OF THE PEDIATRIC SECTION OF THE PACKAGE INSERT
M-17 INFORMATION REGARDING USE OF ULTANE IN PEDIATRIC PATIENTS WITH CONGENITAL HEART
DISEASE
M-18 INFORMATION DENOTING THE EFFICACY OF REMERON IN MAINTAINING A RESPONSE IN PATIENTS
M-19
WITH MAJOR DEPRESSIVE DISORDER (MDD)
INFORMATION REGARDING USE IN PEDIATRIC PATIENTS TWO YEARS OF AGE AND OLDER
M-20 LABELING REVISIONS RELATED TO MCCUNE ALBRIGHT SYNDROME
M-21 COMPARISON DATA ON THE ANTIHYPERTENSIVE EFFECTS OF ATACAND AND COZAAR
M-22 CHANGE IN TIME TO ONSET OF ACTION
M-23 INFORMATION REGARDING ELIMINATION ADDED TO CLINICAL PHARMACOLOGY, STUDY RESULTS IN
PATIENTS WITH HEPATIC AND RENAL IMPAIRMENT
M-24 INFORMATION ON RESULTS OF A LONG TERM LONGITUDINAL GROWTH STUDY AND PEDIATRIC
SAFETY INFORMATION
M-25 ADDITIONAL SAFETY & PK INFORMATION IN CHILDREN 6 MONTHS TO LESS THAN 6 YEARS OF
AGE ADDED TO PKG INSERT
M-26 INCORPORATION OF INFORMATION CONTAINED IN THE PEG-INTRON PACKAGE INSERT INTO THE
REBETOL PACKAGE INSERT AND MEDGUIDE-PEG-INTRON WAS APPROVED FOR USE IN COMBINATION
M-27
WITH REBETOL FOR TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION ON 8/7/01
INFORMATION DESCRIBING ASPIRIN ENDOSCOPY STUDY AND THE MAXIMUM RECOMMENDED DOSE
FOR PATIENTS WITH MODERATE HEPATIC INSUFFICIENCY
M-28 INFORMATION FROM A STUDY IN PEDIATRIC PATIENTS IN ASSOCIATION WITH A NEUROLOGICAL
CONDITION
M-29 LABELING CHANGES TO PROVIDE INFORMATION IN THE MANAGEMENT OF OBESITY IN
ADOLESCENTS AGED 12 TO 16 YEARS
M-30 CHANGES TO CLINICAL PHARMACOLOGY, PRECAUTIONS, AND DOSAGE AND ADMINISTRATION
SECTIONS OF LABELING CONCERNING USE OF LOTENSIN IN PEDIATRIC PATIENTS WITH
HYPERTENSION
M-31 INFORMATION FOR USE IN PEDIATRIC PATIENTS WITH CHRONIC KIDNEY DISEASE STAGE 5
M-32
(END-STAGE RENAL DISEASE)
ADDITIONAL LANGUAGE TO CLINICAL PHARMACOLOGY AND CLINICAL STUDIES
M-33 INFORMATION FOR USE OF ADVAIR DISKUS 100/50 IN CHILDREN 4 TO 11 YEARS OF AGE WITH
ASTHMA
M-34 EXPANDED INFORMATION TO PEDIATRIC USE SUBSECTION OF LABELING IN RESPONSE TO
M-35
PEDIATRIC WRITTEN REQUEST
ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH ACTOS IN COMBINATION
M-36
WITH METFORMIN, A SULFONYLUREA, OR INSULIN ADDED TO CLINICAL PHARMACOLOGY
ADDITION OF INFORMATION TO CLINICAL STUDIES REGARDING PREVENTION OF CARDIOVASCULAR
DISEASE
M-37 INFORMATION ADDED TO THE LABELING THAT DETAILS INFORMATION RELATIVE TO STUDIES
DONE IN PEDIATRIC POPULATIONS IN THE CLINICAL PHARMACOLOGY AND PEDIATRIC USE
SUBSECTIONS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 23 of 62
EXCLUSI VI TY MI SCELLANEOUS
M-38 SAFETY AND IOP-LOWERING EFFECTS OF TRUSOPT HAVE BEEN DEMONSTRATED IN PEDIATRIC
PATIENTS IN A 3 MONTH, MULTI-CENTER DOUBLE MASKED ACTIVE-TREATMENT-CONTROLLED
TRIAL
M-39 FOR LABELING CHANGES BASED ON RESULTS OF THE SPD422-202 CLINICAL STUDY REPORT
M-40
(CSR) SUBMITTED IN RESPONSE TO THE WRITTEN REQUEST
ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED IN PEDIATRIC PATIENTS
WITH LEUKEMIA ADDED TO PRECAUTIONS
M-41 REVISION TO THE PEDIATRIC USE PRECAUTIONS OF THE PRESCRIBING INFORMATION TO
INCORPORATE THE RESULTS FROM THE CAPPS-169 STUDY ENTITLED "THE EFFECT OF ORTHO
TRICYCLEN ON BONE MINERAL DENISTY IN PEDIATRIC SUBJECTS WITH ANOREXIA NERVOSA"
M-42 ADDITION OF A GERIATRIC USE SUBSECTION TO THE PRECAUTIONS SECTION OF THE PACKAGE
INSERT AND GERIATRIC DOSING INFORMATION
M-43 INCLUSION OF RESULTS OF STUDY-"PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY AND
PILOT EFFICACY OF ILOPROST AS ADD ON THERAPY WITH BOSENTAN IN SUBJECTS WITH
PULMONARY ARTERIAL HYPERTENSION
M-44 CLINICAL INFORMATION ADDED TO THE PEDIATRIC USE SUBSECTION OF PRECAUTIONS
REGARDING THE USE OF NOVOLOG IN ADOLESCENTS WITH TYPE I DIABETES AGE 6 TO 18
M-45 INFORMATION ADDED TO CLINICAL TRIALS SECTION OF LABELING - EFFECTS OF HUMATROPE
TREATMENT IN ADULTS WITH GROWTH HORMONE DEFICIENCY
M-46 PROVISION OF RESULTS OF STUDY AND PROPOSED REVISIONS TO PACKAGE INSERT SEE SECTION
ON CARDIAC ELECTROPHYSIOLOGY
M-47 PROVIDES FOR USE OF ANTARA WITHOUT REGARD TO MEALS
M-48 CHANGES TO THE LABELING DESCRIBING THE RESULTS OF A STUDY OF THE USE OF NOVOLOG
M-49
MIX 70/30 WITH ORAL ANTIDIABETIC AGENTS IN PATIENTS WITH TYPE 2 DIABETES
CLINICAL DATA ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING EFFECT OF
SINGULAIR ON GROWTH RATES IN PREPUBERTAL CHILDREN
M-50 NEW INFO TO THE CLINICAL STUDIES, ADULT GROWTH HORMONE DEFICIENCY (GHD) SUBSECTION
OF THE NUTROPIN AQ PACKAGE INSERT DESCRIBING THE EFFECTS OF SOMATROPIN ON VISCERAL
ADIPOSE TISSUE IN THE ADULT GROWTH HORMONE DEFICIENT PATIENT POPULATION
M-51 INFORMATION ADDED TO LABELING REGARDING OSTEOGENESIS IMPERFECTA STUDY
M-52 INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY/CLINICAL STUDIES SECTION REGARDING
THE USE OF RISEDRONATE ADMINISTERED ONCE A WEEK IN THE PREVENTION OF OSTEOPOROSIS
IN POSTMENOPAUSAL WOMEN
M-53 FOR LABELING CHANGES TO THE QUALITY OF LIFE (QOL) STATEMENT IN THE APPROVED
PACKAGE INSERT
M-54 INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
M-55 INFORMATION ON RESULTS OF A STUDY OF THE USE OF SANDOSTATIN LAR DEPOT IN PEDIATRIC
PATIENTS WITH HYPOTHALAMIC OBESITY.
M-56 INFORMATION ADDED TO CLINICAL TRIAL SECTION WITH INFORMATION ON "GEMINI" TRIAL
M-57 CLINICAL DATA ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING THE
PHARMACOKINETICS OF EZETIMIBE IN ASIAN SUBJECTS
M-58 CHANGES TO THE CLINICAL STUDIES, PRIMARY HYPERCHOLESTEROLEMIA, VYTORIN SUBSECTION
OF THE PACKAGE INSERT TO ADD EFFICACY DATA FOR THE EZETIMIBE/SIMVASTATIN
COMBINATION PRODUCT AND FOR AN ATORVASTATIN PRODUCT ON LDL-C AND OTHER LIPID
PRMTRS
M-59 RESULTS OF THE T20-310 STUDY WHICH EVALUATED THE PHARMACOKINETICS, SAFETY, AND
ANTIVIRAL ACTIVITY OF FUZEON IN TREATMENT EXPERIENCED PEDIATRIC SUBJECTS AND
ADOLSCENTS WAS ADDED TO THE PEDIATRIC SUBSECTION OF PRECAUTIONS
M-60 CHANGES TO CLINICAL STUDIES, PRIMARY HYPERCHOLESTEROLEMIA, TO ADD EFFICACY DATA
FOR THE EZETIMIBE/SIMVASTATIN COMBINATION PRODUCT AND FOR A ROSUVASTATIN PRODUCT
ON LDL-C AND OTHER LIPID PARAMETERS IN PATIENTS WTH HYPERCHOLESTEROLEMIA
M-61 REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN
M-62
REQUEST
CLINICAL INFORMATION FROM ONE CLINICAL STUDY INVESTIGATING THE USE OF AVANDAMET
PLUS INSULIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE NOT ACHIEVED
M-63
ADEQUATE GLYCEMIC CONTROL WITH PREVIOUS ANTI-DIABETIC THERAPIES
DETAILED INFORMATION ON AN INCONCLUSIVE PEDIATRIC STUDY
M-64 CHANGES TO CLINICAL PHARMACOLOGY DETAILING STUDY RESULTS
M-65 ADDITION OF INFORMATION TO LABEL TO INCLUDE INFORMATION REGARDING USE IN PATIENTS
M-66
WITH HIV-ASSOCIATED ADIPOSE REDISTRIBUTION SYNDROME (HARS)
USE IN SPECIFIC POPULATIONS - PATIENTS WITH CONCOMITANT ILLNESS SUBSECTION OF THE
LABELING REGARDING USE OF STRATTERA IN PATIENTS WITH ADHD WHO HAVE COMORBID TIC
DISORDER
M-67 INDICATION EXPANDED TO INCLUDE PATIENTS ON PERITONEAL DIALYSIS
M-68 DESCRIPTION OF RESULTS OF STUDY OF INITIAL THERAPY IN COMBINATION WITH METFORMIN
WHEN DIET AND EXERCISE DO NOT PROVIDE GLYCEMIC CONTROL
M-69 RESULTS OF STUDY OF COMBINATION THERAPY AND NON-INFERIORITY STUDY
M-70 PROVISION OF INFORMATION OF THE RESULTS OF A PHASE 2 RANDOMIZED TRIAL OF SPRYCEL
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 24 of 62
EXCLUSI VI TY MI SCELLANEOUS
70MG TWICE DAILY OR IMATINIB 800MG DAILY
M-71 REVISIONS TO PROVIDE FOR RESULTS OF MAINTENANCE DATA IN ADULT PATIENTS WITH MAJOR
DEPRESSIVE DISORDER
M-72 INFORMATION ABOUT USE OF INSPRA (EPLERENONE) FOR HYPERTENSION IN PEDIATRIC
PATIENTS
M-73 NEW INFORMATION ADDED REGARDING THE TUMOR SHRINKING POTENTIAL OF SANDOSTATIN LAR
DEPOT INJECTION ON GH - SECRETING PITUITARY ADENOMAS
M-74 REVISIONS TO CLINICAL STUDIES - CHILDREN AND ADOLSCENTS BASED ON CLINICAL TRIAL
DATA TO SUPPORT A DURATION OF ACTION CLAIM UP TO 12 HOURS
M-75 PROVISION FOR USE OF ARGAGATROBAN IN CERTAIN PEDIATRIC PATIENTS WITH HEPARIN-
M-76
INDUCED THROMBOCYTOPENIA (HIT) OR HEPARIN-INDUCED THROMBOCYTOPENIA WITH THROMBOSIS
(HITTS)
REMOVAL OF SCREEN REQUIREMENT IN PTS WITH G6PD DEFICIENCY PRIOR TO INITIATING
ACZONE TREATMENT; REMOVAL OF BLOOD COUNT & RETICULOCYTE MONITORING DURING
TREATMENT IN G6PD DEFICIENT PTS AND IN PATIENTS WITH HISTORY OF ANEMIA
M-77 USE IN COMBINATION WITH THE NEW AKTILITE CL128 LAMP FOR THE TREATMENT OF THIN AND
MODERATELY THICK, NON-HYPERKERATOTIC, NON-PIGMENTED ACTINIC KERATOSES OF THE FACE
AND SCALP IN IMMUNOCOMPETENT PATIENTS
M-78 CLINICAL TRIAL INFO ON USE OF STRATTERA IN PATIENTS WITH ATTENTION DEFICIT
HYPERACTIVITY DISORDER (ADHD) AND COMORBID ANXIETY DISORDER WITHOUT CAUSING
WORSENING OF ANXIETY
M-79 LABELING REVISIONS RELATED TO SMOKING AND ERLOTIMB EXPOSURE
M-80
M-81
M-82
ADDITIONAL TIME POINT OF 30 MINUTES (0.5 HOUR) IN CHILDREN AGED 6-12 YEARS WITH A
DIAGNOSIS OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD)
ADDITIONAL INFO FOR PEDIATRIC USE FOR CASODEX (STUDIED IN COMBINATION WITH
ARIMIDEX) IN THE PEDIATRIC POPULATION, SPECIFICALLY BOYS WITH FAMILIAL MALE-
LIMITED PRECOCIOUS PUBERTY (TESTOXICOSIS)
LABELING REVISIONS RELATED TO CLINICAL STUDIES
M-83 ADDITIONAL INFORMATION ADDED TO LABELING REGARDING ESTABLISHMENT OF EFFICACY IN
ADDITIONAL CLINICAL TRIALS AND ONE MAINTENANCE TRIAL
M-84 STUDY INFORMATION ADDED TO LABEL REGARDING BONE MINERAL DENSITY
M-85 INFORMATION ADDED TO LABELING REGARDING USE OF PREVACID IN PATIENTS LESS THAN 1
YEAR WITH SYMPTOMATIC GERD
M-86 LABELING CHANGES SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST FOR INFANTS
AGES BIRTH TO 11 MONTH INCLUSIVE REFLECTING LACK OF EFFICACY FOR GERD INDICATION
FOR THIS PATIENT POPULATION
M-87 INCLUSION OF RESULTS FROM TWO DRUG INTERACTION STUDIES WITH LIPITOR AND CRESTOR IN
CLINICAL PHARMACOLOGY SECTION
M-88 ADDITION OF INFORMATION REGARDING ABUSE POTENTIAL OF CONCERTA VERSUS IMMEDIATE-
RELEASE METHYLPHENIDATE
M-89 PROVIDES FOR REVISIONS TO MULTIPLE SECTIONS OF THE PACKAGE INSERT TO REFLECT
RESULTS OF CLINICAL TRIALS 205.235 (UPLIFT) AND 205.266 (VA STUDY) IN SUPPORT OF
EXACERBATION CLAIM
M-90 LABELING CHANGES BASED ON DATA FROM CLINICAL STUDIES NV20235 AND NV20236 STUDIES
OF SEASONAL PROPHYLAXIS OF INFLUENZA IN IMMUNOCOMPROMISED PATIENTS AND CHILDREN
AGES 1-12
M-91 UPDATED LABELING BASED UPON STUDY: A SINGLE-DOSE, SINGLE-BLIND, PLACEBO-AND
MOXIFLOXACIN-CONTROLLED 2-PERIOD, RANDOMIZED, CROSSOVER, 3RD PERIOD SEQUENTIAL
STUDY OF SIDE EFFECTS OF TEMSIROLIMUS ON CARDIAC REPOLARIZATION IN HEALTHY
SUBJECTS
M-92 UPDATES TO THE PACKAGE INSERT BASED UPON THE TRIAL ENTITLED "A PHASE I
PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF TEMSIROLIMUS IN PATIENTS WITH
ADVANCED MALIGNANCIES AND NORMAL AND IMPAIRED LIVER FUNCTION
M-93 EXPANSION OF LABELING TO INCLUDE INFORMATION ON SAFETY AND EFFICACY OF CREON IN
PATIENTS AGES 7 YEARS THROUGH 11 YEARS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE
TO CYSTIC FIBROSIS
M-94 INFO ADDED TO LABEL RELATED TO NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME POSITIVE
M-95
(PH+) CHRONIC MYELOID LEUKEMIA IC CHRONIC PHASE
INFORMATION FOR TREATMENT OF CHRONIC HEPATITIS B (CHB) IN ADULT PATIENTS WITH
DECOMPENSATED LIVER DISEASE BASED ON DATA FROM CLINICAL TRIAL GS-US-174-0108
M-96 UPDATED INFORMATION IN THE CLINICAL STUDIES SECTION RELATED TO THE LOSS AND
RECOVERY OF BONE MINERAL DENSITY IN ADOLESCENT GIRLS DURING AND FOLLOWING THE USE
OF DEPO-PROVERA CONTRACEPTIVE INJECTION
M-97 LABELING CHANGES IN RESPONSE TO PEDIATRIC STUDIES - NOT INDICATED FOR USE IN
PEDIATRIC POPULATION
M-98 NEW INFORMATION FROM A STUDY WHICH EVALUATED THE SAFETY AND EFFICACY OF FAMVIR IN
TREATING RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT BLACK/AFRICAN AMERICAN
SUBJECTS.
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 25 of 62
EXCLUSI VI TY MI SCELLANEOUS
M-99 ADDITION OF FINDINGS FROM A SINGLE PEDIATRIC CLINICAL TRIAL (P04292) OF NASONEX
NASAL SPRAY IN THE TREATMENT OF NASAL POLYPS IN PATENTS 6 TO <18 YEARS OF AGE TO
THE PACKAGE INSERT.
M-100 INFORMATION ADDED TO LABEL BASED UPON COMPLETED CLINICAL TRIAL REPORTS
M-101 INCLUSION OF DATA FROM AN ADDITIONAL 19 SUBJECTS WITH HYPERCALCEMIA FROM
PARATHYROID CARCINOMA TO THE INFORMATION CURRENTLY PRESENTED IN THE LABEL
M-102 INFORMATION FROM PEDIATRIC STUDY REPORT ML16633, "INTRAVENOUS GRANISETRON (KYTRIL)
IN THE PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING (PONV) IN PEDIATRIC
SUBJECTS UNDERGOING TONSILLECTOMY OR ADENOTONSILLECTOMY."
M-103 SAFETY, EFFICACY AND PHARMACOKINETIC INFO FOR FASLODEX IN THE PEDIATRIC
POPULATION, SPECIFICALLY FOR GIRLS WITH PROGRESSIVE PRECOCIOUS PUBERTY ASSOCIATED
WITH MCCUNE-ALBRIGHT SYNDROME ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING
M-104 INFORMATION ADDED TO DOSING AND ADMINISTRATION REGARDING A 26 WEEK STUDY
M-105 NEW LANGUAGE ADDED TO CLINICAL STUDIES REGARDING USE IN SMOKERS WITH
M-106
CARDIOVASCULAR DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND USE ACCORDING
TO AN ALTERNATIVE SET OF DIRECTIONS FOR SETTING A QUIT DATE
ADDITION OF THE T1-WEIGHTED GD-ENHANCED LESION EFFICACY VARIABLE IN THE CLINICAL
STUDIES SECTION 14 OF THE PACKAGE INSERT
M-107 INFORMATION TO THE CLINICAL STUDIES SECTION OF THE LUPRON DEPOT-PED,1-MONTH,BASED
UPON THE PHASE 3/4 COMPLETED CLINICAL STUDY REPORT FOR STUDY M90-516, ENTITLED
"STUDY OF LUPRON DEPOT IN THE TREATMENT OF CENTRAL PRECOCIOUS PUBERTY".
M-108 CHANGES ARE BASED ON RESULTS FROM STUDY CV181057
M-109 CHANGES TO THE PACKAGE INSERT TO REFLECT THE RESULTS OF THE STUDY OF HEART AND
M-110
RENAL PROTECTION (SHARP) TRIAL
CHANGES TO THE PACKAGE INSERT TO REFLECT THE RESULTS OF THE STUDY OF HEART AND
M-111
RENAL PROTECTION (SHARP) TRIAL
LABELING CHANGES BASED ON STUDY HW80-EW-GWCI ENTITLED A PLACEBO AND POSITIVE
CONTROLLED STUDY OF THE ELECTROPHYSIOLOGICAL EFFECTS OF A SINGLE 10 MCG DOSE OF
M-112
EXENATIDE ON THE 12 LEAD ELECTROCARDIOGRAM QT INTERVAL IN HEALTHY SUBJECTS
REVISIONS TO THE PEDIATRIC USE SECTION OF THE PACKAGE INSERT TO ADD INFORMATION
FROM A PEDIATRIC STUDY IN PATIENTS AGED 12 YEARS TO LESS THAN 18 YEARS OF AGE WITH
RECURRENT HERPES LABIALIS
M-113 LABELING CHANGES BASED ON STUDY H80-US-GWCO ENTITLED A RANDOMIZED TRIAL COMPARING
EXENATIDE WITH PLACEBO IN SUBJECTS WITH TYPE 2 DIABETES ON INSULIN GLARGINE WITH
OR WITHOUT ORAL ANTIHYPERGLYCEMIC MEDICATIONS
M-114 CHANGES IN SECTION 14 OF THE PACKAGE INSERT TO INCLUDE DATA FROM THE SWITCHMRK
M-115
STUDIES (SWITCH OF SUPPRESSED SUBJECTS FROM LOPINAVIR/RITONAVIR TO RALTEGRAVIR)
REVISIONS TO THE PI BASED ON RESULTS FROM STUDY NN2211-1842, ENTITLED THE EFFECT
OF INSULIN DETEMIR IN COMBINATION WITH LIRAGLUTIDE AND METFORMIN COMPARED TO
LIRAGLUTIDE AND METFORMIN IN SUBJECTS WITH TYPE 2 DIABETES
M-116 LABELING CHANGES BASED ON RESULTS FROM CLINICAL STUDY 01-06-TL-OPIMET-008
M-117 ADDITION OF RESULTS OF PEDIATRIC TRIAL TO LABEL
M-118 LABELING CHANGES BASED UPON SAFETY AND EFFICACY RESULTS FROM TRIAL 1218.36
M-119 LABELING CHANGES REGARDING MISSED DOSES
M-120 CHANGES TO CLINICAL TRIALS DETAILING STUDY RESULTS
M-121 LABELING CHANGES BASED UPON SAFETY AND EFFICACY RESULTS FROM TRIAL 1218.43
M-122 LABELING CHANGES TO INCLUDE THE RESULTS OF THE PARAMOUNT TRIAL
M-123 UPDATED RESULTS OF OVERALL SURVIVAL FROM 'CONFIRM' STUDY
M-124 LONG TERM SAFETY AND EFFICACY DATA FROM STUDY CLDT600A2303 FOR SUBJECTS PREVIOUSLY
ENROLLED IN THE ORIGINAL TWO YEAR GLOBE (NV-02B-007/CLDT600A2302) AND NV02B-015
STUDIES WHO CONTINUED TELBIVUDINE TREATMENT FOR UP TO 208 WEEKS
M-125 LABELING CHANGES TO INCLUDE LACK OF EFFICACY IN CHILDREN 6 MONTHS TO 4 YEARS OF
AGE
M-126 UPDATES TO THE CLINICAL STUDIES SECTION 14, OF THE PACKAGE INSERT (PI), WITH THE
RESULTS OF CLINICAL TRIAL P06086
M-127 REVISIONS TO THE PEDIATRIC USE SECTION OF THE PACKAGE INSERT TO REFLECT THE
RESULTS FROM CLINICAL STUDY C-10-004
M-128 CLINICAL TRIAL STUDY RESULTS
M-129 RESULTS OF A CLINICAL STUDY REPORT WHICH ASSESSES THE SAFETY AND EFFICACY IN
CHILDREN AGES 6 TO 12 YEARS OF AGE
M-130 ADDITION OF INFORMATION ON LONG-TERM TREATMENT WITH VPRIV IN THE CLINICAL TRIALS
SECTION OF THE PACKAGE INSERT
M-131 INFORMATION FROM STUDIES CONDUCTED IN PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED NON-
DISSEMINATED DIFFUSED INTRINSIC BRAINSTEM GLIOMAS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 26 of 62
PATENT USE
U-1 PREVENTION OF PREGNANCY
U-2 TREATMENT OR PROPHYLAXIS OF ANGINA PECTORIS AND ARRHYTHMIA
U-3 TREATMENT OF HYPERTENSION
U-4 PROVIDING PREVENTION AND TREATMENT OF EMESIS AND NAUSEA IN MAMMALS
U-5 METHOD OF PRODUCING BRONCHODILATION
U-6 METHOD OF PRODUCING SYMPATHOMIMETIC EFFECTS
U-7 INCREASING CARDIAC CONTRACTILITY
U-8 ACUTE MYOCARDIAL INFARCTION
U-9 CONTROL OF EMESIS ASSOCIATED WITH ANY CANCER CHEMOTHERAPY AGENT
U-10 DIAGNOSTIC METHOD FOR DISTINGUISHING BETWEEN HYPOTHALMIC MALFUNCTIONS OR LESIONS
IN HUMANS
U-11 TREATMENT OR PROPHYLAXIS OF CARDIAC DISORDERS
U-12
U-13
METHOD OF TREATING [A] HUMAN SUFFERING FROM DEPRESSION
A METHOD FOR TREATING ANXIETY IN A HUMAN SUBJECT IN NEED OF SUCH TREATMENT
U-14 ADJUNCTIVE THERAPY FOR THE PREVENTION AND TREATMENT OF HYPERAMMONEMIA IN THE
CHRONIC MANAGEMENT OF PATIENTS WITH UREA CYCLE ENZYMOPATHIES
U-15 METHOD OF LOWERING INTRAOCULAR PRESSURE
U-16 USE IN LUNG SCANNING PROCEDURES
U-17 TREATMENT OF VENTRICULAR AND SUPRAVENTRICULAR ARRHYTHMIAS
U-18 METHOD FOR INHIBITING GASTRIC SECRETION IN MAMMALS
U-19 TREATMENT OF INFLAMMATION
U-20 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED
OF TREATMENT
U-21 TREATMENT OF HUMANS SUFFERING UNDESIRED UROTOXIC SIDE EFFECTS CAUSED BY
CYTOSTATICALLY ACTIVE ALKYLATING AGENTS
U-22 METHOD OF COMBATTING PATHOLOGICALLY REDUCED CEREBRAL FUNCTIONS AND PERFORMANCE
WEAKNESSES, CEREBRAL INSUFFICIENCY AND DISORDERS IN CEREBRAL CIRCULATION AND
METABOLISM IN WARM-BLOODED ANIMALS
U-23 METHOD FOR TREATING PROSTATIC CARCINOMA COMPRISING ADMINISTERING FLUTAMIDE
U-24 METHOD FOR TREATING PROSTATE ADENOCARCINOMA COMPRISING ADMINISTERING AN
ANTIANDROGEN INCLUDING FLUTAMIDE AND AN LHRH AGONIST
U-25 REDUCING CHOLESTEROL IN CHOLELITHIASIS PATIENTS
U-26
U-27
U-28
REDUCING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF
DISSOLVING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF
CEREBRAL, CORONARY, PERIPHERAL, VISCERAL AND RENAL ARTERIOGRAPHY, AORTOGRAPHY AND
LEFT VENTRICULOGRAPHY
U-29
U-30
U-31
CT IMAGING OF THE HEAD AND BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY
CEREBRAL ANGIOGRAPHY, AND VENOGRAPHY
INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY
U-32 PALLIATIVE TREATMENT OF PATIENTS WITH OVARIAN CARCINOMA RECURRENT AFTER PRIOR
U-33
CHEMOTHERAPY, INCLUDING PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED WITH CISPLATIN
TREATING VIRAL INFECTIONS IN A MAMMAL
U-34 TREATING VIRAL INFECTIONS IN A WARM-BLOODED ANIMAL
U-35 TREATING CYTOMEGALOVIRUS IN A HUMAN WITH AN INJECTABLE COMPOSITION
U-36 METHODS OF TREATING BACTERIAL ILLNESSES
U-37 METHOD OF TREATING GASTROINTESTINAL DISEASE
U-38 TREATMENT OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA
U-39 ANGINA PECTORIS
U-40 METHOD OF TREATMENT OF BURNS
U-41 METHOD OF TREATING CARDIAC ARRHYTHMIAS
U-42 ADJUVANT TREATMENT IN COMBINATION WITH FLUOROURACIL AFTER SURGICAL RESECTION IN
PATIENTS WITH DUKES' STAGE C COLON CANCER
U-43
U-44
MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
RELIEF OF NAUSEA AND VOMITING
U-45 TREATMENT OF INFLAMMATION AND ANALGESIA
U-46 TREATMENT OF PANIC DISORDER
U-47 STIMULATION OF THE RELEASE OF GROWTH HORMONE
U-48 ANALGESIA
U-49 SYMPTOMATIC CANCER-RELATED HYPERCALCEMIA
U-50 USE IN TREATING INFLAMMATORY DERMATOSES
U-51 BLOOD POOL IMAGING, INCLUDING CARDIAC FIRST PASS AND GATED EQUILIBRIUM IMAGING AND
FOR DETECTION OF SITES OF GASTROINTESTINAL BLEEDING
U-52 TREATMENT OF ADULT AND PEDIATRIC PATIENTS(OVER SIX MONTHS OF AGE) WITH ADVANCED
HIV INFECTION
U-53 HYPERCALCEMIA OF MALIGNANCY
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 27 of 62
PATENT USE
U-54 REVERSAL AGENT OR ANTAGONIST OF NONDEPOLARIZING NEUROMUSCULAR BLOCKING AGENTS
U-55 TREATMENT OF PAIN
U-56 AID TO SMOKING CESSATION
U-57 OPHTHALMIC USE OF NORFLOXACIN
U-58 METHOD OF TREATING INFLAMMATORY INTESTINAL DISEASES
U-59 METHOD OF TREATING HYPERCHOLESTEROLEMIA
U-60 NASAL ADMINISTRATION OF BUTORPHANOL
U-61 CEREBRAL AND PERIPHERAL ARTERIOGRAPHY AND CT IMAGING OF THE HEAD
U-62
U-63
CORONARY ARTERIOGRAPHY, LEFT VENTRICULOGRAPHY, CT IMAGING OF THE BODY, INTRAVENOUS
EXCRETORY UROGRAPHY, INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY AND VENOGRAPHY
ISOPRENALINE ANTAGONISM ON THE HEART RATE OR BLOOD PRESSURE
U-64 TREATMENT OF VIRAL INFECTIONS
U-65 METHOD OF TREATMENT OF A PATIENT INFECTED WITH HIV
U-66 TRIPHASIC REGIMEN
U-67 METHOD OF INDUCING ANESTHESIA IN A WARM BLOODED ANIMAL
U-68 TREATMENT OF ACTINIC KERATOSIS
U-69 TREATMENT OF PNEUMOCYSTIS CARINII INFECTIONS
U-70 TREATMENT OF TRANSIENT INSOMNIA
U-71 METHOD OF TREATMENT OF HEART FAILURE
U-72 TREATMENT OF MIGRAINE
U-73 METHOD OF TREATING DISEASES OR INFECTIONS CAUSED BY MYCETES
U-74 METHOD OF PROVIDING HYPNOTIC EFFECT
U-75 RELIEF OF OCULAR ITCHING DUE TO SEASONAL ALLERGIC CONJUNCTIVITIS
U-76 USE TO IMAGE A SUBJECT WITH A MAGNETIC RESONANCE IMAGING SYSTEM
U-77 TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
U-78 ULCERATIVE COLITIS
U-79 SYMPTOMATIC TREATMENT OF PATIENTS WITH NOCTURNAL HEARTBURNDUE TO GERD
U-80 METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
U-81 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS
U-82 TREATMENT FOR DEMENTIA IN PATIENTS WITH ALZHEIMER'S DISEASE
U-83 TREATMENT OF SEIZURES
U-84 A METHOD OF BLOCKING THE UPTAKE OF MONOAMINES BY BRAIN NEURONS IN ANIMALS
U-85 NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
U-86 METHOD OF TREATING CERTAIN FORMS OF EPILEPSY
U-87
U-88
U-89
METHOD FOR NONINVASIVE ADMINISTRATION OF SEDATIVES, ANALGESICS, AND ANESTHETICS
TREATMENT OF MODERATE PLAQUE PSORIASIS
TREATMENT OR PROPHYLAXIS OF EMESIS
U-90 TREATMENT OF PYSCHOTIC DISORDERS
U-91 ALTERNATIVE THERAPY TO TRIMETHOPRIM-SULFAMETHOXAZOLE FOR TREATMENT OF MODERATE-TO-
SEVERE PNEUMOCYSTIS CARINII PNEUMONIA IN IMMUNOCOMPROMISED AND AIDS PATIENTS
U-92 TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN DEPENDENT
DIABETES MELLITUS AND RETINOPATY
U-93
U-94
USE AS AN ANTIHISTAMINE/DECONGESTANT
TREATMENT-ADULTS W/ ADVANCED HIV,INTOLERANT OF APPROVED THERAPIES,INTOLERANT OF
APPROVED THERAPIES W/PROVEN BENEFIT OR HAVE EXPERIENCED CLINICAL/IMMUNOLOGICAL
DETERIORATION WHILE RECEIVING..OR FOR WHOM SUCH THERAPIES-CONTRAINDICATED
U-95 SHORT TERM MANAGEMENT OF MODERATE PRURITIS IN ADULTS WITH ATOPIC DERMATITIS AND
LICHEN SIMPLEX CHRONICUS
U-96
U-97
METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS
A METHOD OF TREATING A PATIENT IN NEED OF MEMORY ENHANCEMENT
U-98 A METHOD OF INDUCING REGRESSION OF LEUKEMIA CELL GROWTH IN A MAMMAL
U-99 METHOD OF PROVIDING POTASSIUM TO A SUBJECT IN NEED OF POTASSIUM
U-100 METHOD OF TREATING OCULAR INFLAMMATION
U-101 ADJUNCT TO CONVENTIONAL CT OR MRI IMAGING IN THE LOCALIZATION OF STROKE IN
PATIENTS IN WHOM STROKE HAS ALREADY BEEN DIAGNOSED
U-102 METHOD OF HORMONALLY TREATING MENOPAUSAL OR POST-MENOPAUSAL DISORDERS IN WOMEN
U-103 TREATMENT OF OCULAR HYPERTENSION
U-104
U-105
TREATMENT OF AQUEOUS HUMOR FORMATION AND INTRAOCULAR PRESSURE
EMESIS
U-106 TREATMENT OF EPILEPSY
U-107 TREATMENT OF HYPERTENSION AND ANGINA PECTORIS
U-108 SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER, GASTROESOPHAGEAL REFLUX DISEASE
(GERD), SEVERE EROSIVE ESOPHAGITIS, POORLY RESPONSIVE SYMPTOMATIC GERD AND
PATHOLOGIAL HYPERSECRETORY CONDITIONS AND MAINTENANCE HEALING OF EROSIVE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 28 of 62
PATENT USE
ESOPHAGITIS
U-109 ADJUNCT DIET IN THE TX OF ELEVATED TOTAL CHOLESTEROL AND LDL-C LEVELS IN PTS
U-110
W/PRIMARY HYPERCHOLESTEROLEMIA WHOSE RESPONSE TO DIETARY RESTRICTION OF SAT FAT
AND CHOLESTEROL AND OTHER NONPHARMACOLOGICAL MEASURES HAS NOT BEEN ADEQUATE
USE AS A RETRIEVABLE PERSSARY
U-111 DIABETES
U-112 CONTRACEPTION
U-113 METHOD OF CONDUCTING RADIOLOGICAL EXAMINATION OF A PATIENT BY ADMINISTERING TO
U-114
SAID PATIENT A RADIOPAQUE AMOUNT OF IOPROMIDE
USE FOR INHIBITING BONE RESORPTION
U-115
U-116
USE OF VASODILATORS TO EFFECT AND ENHANCE AN ERECTION (AND THUS TREAT ERECTILE
DYSFUNCTION), BY INJECTION INTO THE PENIS
METHOD OF MYOCARDIAL IMAGING
U-117 TREATMENT OF OCULAR ALLERGIC RESPONSE IN HUMAN EYES
U-118 METHOD OF LOWERING BLOOD SUGAR LEVEL
U-119 TREATMENT OF NASAL HYPERSECRETION
U-120 CONTROLLING OR PREVENTING POST-OPERATIVE INTRAOCULAR PRESSURE RISES ASSOCIATED
WITH OPHTHALMIC LASER SURGICAL PROCEDURES
U-121 METHOD OF TREATING CONDITIONS MEDIATED THROUGH HISTAMINE H2-RECEPTORS
U-122 A THERAPEUTIC METHOD FOR CONTROLLING THROMBOSIS
U-123 METHOD FOR CONTROLLING THROMBOSIS AND DECREASING BLOOD HYPERCOAGULATION AND
HEMORRHAGING RISKS
U-124 TREATMENT OF ACNE
U-125 TREATMENT NEUROGENERATIVE DISEASES
U-126 TREATMENT OF GASTRITIS
U-127 METHOD OF PRODUCING NEUROMUSCULAR BLOCKADE
U-128 METHOD FOR TREATMENT OF TUMORS
U-129 METHOD TO DESTROY OR IMPAIR TARGET CELLS
U-130 MANAGEMENT OF PATIENTS WITH MASTOCYTOSIS
U-131 PHOTODAMAGED SKIN
U-132 INHIBITING HIV PROTEASE
U-133 MANAGEMENT OF OBESITY INCLUDING WEIGHT LOSS AND MAINTENANCE IN PATIENTS ON A
REDUCED-CALORIE DIET
U-134 TREATMENT OF ACNE VULGARIS
U-135 ANTITUMOR AGENT
U-136 PROCESS FOR WASTE NITROGEN REMOVAL
U-137 METHOD OF TREATING BACTERIAL VAGINOSIS
U-138 TREATMENT OF ALLERGIC RHINITIS
U-139 TREATMENT OF ALLERGIC REACTIONS
U-140 USE OF NORVIR TO INHIBIT HIV PROTEASE OR TO INHIBIT AN HIV INFECTION
U-141 TREATMENT OF ULCERATIVE COLITIS
U-142 METHOD OF TREATING ALLERGIC REACTIONS IN A MAMMAL BY USING THIS ACTIVE METABOLITE
U-143 BIODEGRADABLE SUPERPARAMAGNETIC METAL OXIDES AS CONTRAST AGENTS FOR MR IMAGING
U-144 BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC MATERIALS FOR USE IN CLINICAL
APPLICATIONS
U-145 BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC PARTICLES FOR USE AS NUCLEAR MAGNETIC
RESONANCE IMAGING AGENTS
U-146 METHOD OF TREATING SUSCEPTIBLE NEOPLASMS IN MAMMALS
U-147 DETECTION OF GASTROINTESTINAL DISORDERS AND THE SUBSEQUENT BREATH COLLECTION AND
MEASUREMENT OF 13CO2
U-148 DEVICE FOR COLLECTING A BREATH SAMPLE
U-149
U-150
METHOD OF TREATING AN ANIMAL, INCLUDING A HUMAN SUFFERING FROM OR SUSCEPTIBLE TO
PSYCHOSIS, ACUTE MANIA OR MILD ANXIETY STATES
METHOD OF USE FOR CONTROLLING HYPERGLYCEMIA BY ADMINISTRATION OF THIS SUSTAINED
RELEASE DOSAGE FORM OF GLIPIZIDE
U-151 RELIEF OF SYMPTOMS OF THE COMMON COLD
U-152 METHOD OF TREATING ANXIETY RELATED DISORDERS INCLUDING OBSESSIVE COMPULSIVE
DISORDER
U-153 TREATMENT OF INITIAL EPISODE GENITAL HERPES
U-154 METHOD OF TREATING ANIMALS SUFFERING FROM AN APPETITE DISORDER
U-155 TREATMENT OF ERECTILE DYSFUNCTION
U-156 METHOD OF PROVIDING ANESTHESIA
U-157 TREATMENT OF A HUMAN SUFFERING FROM VITAMIN B12 DEFICIENCY
U-158 ANGINA
U-159 TREATMENT OF INTERSTITIAL CYSTITIS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 29 of 62
PATENT USE
U-160 TREATMENT OF BACTERIAL INFECTIOUS DISEASE
U-161 METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS IN A PATIENT
U-162 METHOD OF USE TO INHIBIT CHOLESTEROL SYNTHESIS IN A HUMAN SUFFERING FROM
HYPERCHOLESTEROLEMIA
U-163 METHOD OF USING TROGLITAZONE TO TREAT IMPAIRED GLUCOSE TOLERANCE TO PREVENT OR
DELAY THE ONSET OF NONINSULIN-DEPENDENT DIABETES MELLITUS
U-164 METHOD OF USING TROGLITAZONE TO PREVENT OR DELAY THE ONSET OF NONINSULIN-DEPENDENT
DIABETES MELLITUS IN A DEFINED POPULATION OF PATIENTS
U-165 TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
U-166 TREATMENT OF H.PYLORI-ASSOCIATED DUODENAL ULCER
U-167 METHOD FOR TREATING HIV-1 INFECTION
U-168 METHOD OF INHIBITING LIPOXYGENASE ACTIVITY IN A MAMMAL WHICH IS THE MODE OF ACTION
IN THE TREATMENT OF ASTHMA
U-169 METHODS OF USING THE COMPOUND/DRUG PRODUCT AS A CONTRAST AGENT IN MAGNETIC
RESONANCE IMAGING
U-170 METHOD OF OBTAINING AN MR IMAGE USING THE COMPOSITION/DRUG PRODUCT AS A CONTRAST
AGENT
U-171 METHODS OF USING THE COMPOUND/DRUG PRODUCT AS AN ORAL CONTRAST AGENT IN MAGNETIC
RESONANCE IMAGING OF THE GASTROINTESTINAL TRACT
U-172 TREATMENT OF GENITAL WARTS
U-173 ADMINISTRATION TO A HOST SUFFERING FROM GESTATIONAL DIABETES
U-174 USE AS AN ANTIHISTAMINE AGENT
U-175 METHOD OF TREATING MALIGNANT TUMORS
U-176 METHOD OF TREATING A PATIENT SUFFERING FROM LISTED CONDITIONS, INCLUDING SPECIFIC
PSYCHOSES
U-177 FUNGICIDE
U-178 FACILITATED ADHERENCE OF AGENTS TO SKIN
U-179 ENHANCED CUTANEOUS PENETRATION OF A DERMALLY-APPLIED PHARMACOLOGICALLY ACTIVE
AGENT
U-180 TREATMENT OF ADULT AND PEDIATRIC PATIENTS (OVER 6 MONTHS OF AGE) WITH ADVANCED HIV
INFECTION
U-181 PRODUCING ALPHA ADRENERGIC ANTAGONISTIC ACTION IN A HOST
U-182 USE OF SALMETEROL IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION
U-183 TREATMENT OF CONDITIONS CAUSED BY DISTURBANCE OF NEURONAL 5HT FUNCTION
U-184 TREATING ALLERGIC EYE DISEASES IN HUMANS
U-185 METHOD OF TREATING HYPERTENSION
U-186 METHOD FOR TREATING GI DISORDERS CAUSED BY H.RYLORI WHICH COMPRISES ADMINISTRATION
OF RANITIDINE BISMUTH CITRATE AND CLARITHROMYCIN FOR A GREATER THAN ADDITIVE
EFFECT
U-187 THERAPEUTIC TREATMENT OF CALCIFIC TUMORS
U-188 TREATMENT OF H.PYLORI ASSOCIATED DUODENAL ULCER
U-189 ENHANCEMENT OF THE BIOAVAILABILITY OF THE DRUG SUBSTANCE
U-190 USE OF RITONAVIR IN COMBINATION WITH ANY REVERSE TRANSCRIPTASE INHIBITOR
U-191 METHOD OF TREATMENT FOR CONTROLLING AND LOWERING INTRAOCULAR PRESSURE IN A HUMAN
U-192 USE IN TREATING ALLERGIC REACTIONS
U-193 PSORIASIS
U-194 TREATING ANGINA PECTORIS AND HIGH BLOOD PRESSURE
U-195 METHOD FOR THE DIAGNOSIS OF GASTROINTESTINAL DISORDERS BY UREA ISOTOAC OR NITROGEN
LABELED CARBON
U-196 TREATMENT OF METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH ESTROGEN
RECEPTOR POSITIVE TUMORS
U-197 USE IN COMBINATION WITH CERTAIN LHRH ANALOGUES FOR THE TREATMENT OF ADVANCED
PROSTATE CANCER
U-198 TREATMENT METASTATIC CARCINOMA OF OVARY AFTER 1ST LINE FAILURE OR SUBSQUENT
CHEMOTHERAPY, TREATMENT OF BREAST CANCER AFTER FAILURE OF COMBINATION CHEMOTHERAPY
FOR METASTATIC DISEASE AND 2ND LINE TREATMENT OF AIDS RELATED KAPOSI'S SARCOMA
U-199 METHOD OF TREATING INFECTIOUS UPPER GI TRACT DISORDERS CAUSED BY CAMPYLOBACTER
PYLORIDIS INFECTION COMPRISING ADMINISTRATION OF A BISMUTH AGENT AND AN
ANTIMICROBIAL AGENT
U-200 METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF A BISMUTH-CONTAINING
AGENT AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT
U-201 METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF CAMPYLOBACTER-
INHIBITING ANTIMICROBIAL AGENT AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT
U-202 METHOD OF TREATING PEPTIC ULCER DISEASE CAUSED BY CAMPYLOBACTER PYLORIDIS
U-203
COMPRISING ORAL ADMINISTRATION OF 50 TO 5,000MG BISMUTH DAILY FOR 3-56 DAYS
TREATMENT OF ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH DISEASE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 30 of 62
PATENT USE
PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
U-204 USE OF TAXOL IN COMBINATION WITH G-CSF FOR TREATMENT OF PATIENTS WITH AIDS-RELATED
KAPOSI'S SARCOMA
U-205 METHOD FOR TREATING HEARTBURN
U-206 METHOD OF USING FSH ALONE, WITHOUT THE PRESENCE OF EXOGENEOUS LH, IN IN VITRO
FERTILIZATION
U-207 USE AS NASAL SPRAY
U-208 VAGINAL ADMINISTRATION USING SPECIFIED FORMULATION
U-209 VAGINAL ADMINISTRATION OF PROGESTERONE USING SPECIFIED FORMULATION
U-210 METHOD OF TREATING CONGESTIVE HEART FAILURE
U-211 USE IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION
U-212 METHOD OF TREATMENT OF PARKINSON'S DISEASE
U-213 METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS AND TREATING HYPERCHOLESTEROLEMIA
AND METHOD FOR TREATING HYPERLIPIDEMIA
U-214 USE AS A BLOOD GLUCOSE-LOWERING AGENT
U-215 TREATMENT OF EPILEPSY TWICE DAILY. TREATING A PATIENT BY ADMINISTERING
CARBAMAZEPINE IN A DOSAGE FORM CAPABLE OF MAINTAINING BLOOD CONCENTRATION FROM 4-
U-216
12MCG/ML OVER 12 HOURS
TREATMENT OF ADENOCARCINOMA, INCLUDING STAGE B2-C BY ADMINISTERING AN AGONIST OF
LH-RH AND FLUTAMIDE
U-217 METHOD OF PRODUCING ANESTHESIA
U-218 METHOD FOR LIMITING THE POTENTIAL FOR MICROBIAL GROWTH IN THE DRUG PRODUCT
U-219 TREATMENT OF PARKINSON'S DISEASE
U-220 METHOD OF DIAGNOSIS
U-221 SELECTIVE VASODILATION BY CONTINUOUS ADENOSINE INFUSION
U-222 METHOD OF TREATING PAGET'S DISEASE USING ACTONEL
U-223 TREATMENT OF BACTERIAL CONJUNCTIVITIS CAUSED BY SUSCEPTIBLE STRAINS OF
MICROORGANISMS
U-224 CONTROLLING INTRAOCULAR PRESSURE
U-225 METHOD FOR DELIVERY
U-226 METHOD OF ENHANCING THE DISSOLUTION PROFILE OF A PHARMACEUTICAL FROM A SOLID
DOSAGE FORM CONTAINING THE PHARMACEUTICAL AND SIMETHICONE
U-227 NASAL ADMINISTRATION
U-228 ASTHMA
U-229
U-230
CARDIAC INSUFFICIENCY (CONGESTIVE HEART FAILURE)
PREVENTION OF ACUTE CARDIAC ISCHEMIC EVENTS
U-231 USE IN PARKINSON'S DISEASE
U-232 METHOD OF TREATING MIGRAINE
U-233 DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE
U-234 METHOD OF USING RIBAVIRIN TO TREAT VIRAL INFECTIONS IN MAMMALS
U-235 METHOD OF MODULATING TH1 AND TH2 RESPONSE IN ACTIVATED T CELLS OF A HUMAN
COMPRISING ADMINISTERING RIBAVIRIN TO THE T CELLS IN A DOSAGE WHICH PROMOTES THE
TH1 RESPONSE AND SUPPRESSES THE TH2 RESPONSE
U-236
U-237
TREATING MALE PATTERN BALDNESS WITH 0.05 TO 3.0MG/DAY
METHOD OF PERFORMING NMR IMAGING WITH A PATIENT COMPRISING ADMINISTERING TO THE
PATIENT AN EFFECTIVE AMOUNT OF CONTRAST AGENT DISCLOSED IN THE CLAIMS
U-238 IMAGING A BODY TISSUE AND SUBJECTING TO NMR TOMOGRAPHY, ADMINISTERING AN AMOUNT OF
PHARMACEUTICAL AGENT FOR AFFECTING THE RELAXATION TIMES OF ATOMS IN BODY TISSUES
U-239
UNDERGOING NMR DIAGNOSIS, WHEREBY THE IMAGE CONTRAST IN ENHANCED....
TREATING OR CONTROLLING OCULAR INFLAMATION WHICH COMPRISES TOPICALLY ADMINISTERING
TO AFFECTED EYE A COMPOSITION COMPRISING AN NSAID, A POLYMERIC QUATERNARY AMMONIUM
COMPOUND AND BORIC ACID
U-240 TREATMENT OF ACUTE MIGRAINE ATTACKS
U-241 FOR SHORT-TERM TREATMENT ACTIVE DUODENAL ULCER, MAINTENANCE THERAPY FOR DUODENAL
ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING OF ACTIVE ULCER, SHORT-TERM
TREATMENT ACTIVE BENIGN GASTRIC ULCER & GERD, PATHOLOGICAL HYPERSECRETORY
CONDITIONS
U-242 USE OF FOLLITROPIN ALPHA ALONE IN IN-VITRO FERTILIZATION
U-243 TOPICAL ADMINISTRATION
U-244 PLATELET AGGREGATION INHIBITORS
U-245 TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
U-246 PHOSPHATE BINDING
U-247 TREATMENT OF RHEUMATOID ARTHRITIS
U-248 TREATMENT OF HIV
U-249 METHOD OF TREATING ALLERGIC OR NON-ALLERGIC RHINITIS IN PATIENTS BY ADMINISTERING
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 31 of 62
PATENT USE
AEROSOLIZED PARTICLES OF MOMETASONE FUROATE
U-250 TREATMENT OF HEPATITIS B INFECTION
U-251 USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS IN THE TREATMENT OF TYPE II
DIABETES
U-252 METHOD OF TREATING A HUMAN SUBJECT HAVING GAUCHER'S DISEASE
U-253 ORAL TRANSMUCOSAL USE
U-254 USE OF AGGRASTAT IN COMBINATION WITH HEPARIN
U-255 IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH
NARCOLEPSY
U-256 TREATMENT OF HIV INFECTION IN COMBINATION WITH ONE OR MORE ADDITIONAL HIV
ANTIVIRAL AGENTS
U-257 TREATMENT OF HIV INFECTION
U-258 TREATMENT OF NEURODEGENERATIVE DISEASES
U-259 TREATMENT OF ANDROGENIC ALOPECIA BY ORAL ADMINISTRATION DRUG SUBSTANCE
U-260 REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA AND OCULAR
HYPERTENSION WHO ARE INTOLERANT OF OTHER IOP LOWERING MEDICATIONS OR
INSUFFICIENTLY RESPONSIVE TO ANOTHER IOP LOWERING MEDICATION
U-261 TREATING BENIGN PROSTATIC HYPERPLASIA WITH A GENUS OF COMPOUNDS, INCLUDING
FINASTERIDE
U-262 TREATING BENIGN PROSTATIC HYPERTROPHY WITH FINASTERIDE
U-263 METHOD OF TREATING A MALIGNANT CONDITION THROUGH INTRAVASCULAR ADMINISTRATION OF
BUSULFAN. METHOD FOR TREATING LEUKEMIA OR LYMPHOMA IN A PATIENT UNDERGOING A BONE
MARROW TRANSPLANT THROUGH INTRAVENOUS ADMINISTRATION OF BUSULFAN
U-264 METHOD OF TREATING A MALIGNANT DISEASE THROUGH PARENTERAL ADMINISTRATION OF
BUSULFAN. METHOD FOR TREATING A PATIENT UNDERGOING A BONE MARROW TRANSPLANT
THROUGH INTRAVASCULAR ADMINISTRATION OF BUSULFAN
U-265 USE AS LAXATIVE
U-266
U-267
RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS; RELIEF OF THE SIGNS AND
SYMPTOMS OF RHEUMATOID ARTHRITIS IN ADULTS; MANAGEMENT OF ACUTE PAIN IN ADULTS;
TREATMENT OF PRIMARY DYSMENNORRHEA; ACUTE TREATMENT OF MIGRAINE ATTACKS IN ADULTS
PREVENTING HEARTBURN EPISODES FOLLOWING INGESTION OF HEARTBURN-INDUCING
U-268
FOOD/BEVERAGE, COMPRISING ADMIN TO PT, 30 MIN PRIOR TO CONSUMPTION BY THE PT THE
FOOD/BEVERAGE, A COMPOSITION COMPRISING 10MG FAMOTIDINE
ACROMEGALY
U-269 EXCESS GH-SECRETION OR GASTRO-INTESTINAL DISORDERS
U-270 METHOD OF IMPROVING THE TIME FOR ADMINISTRATION OR THE TIME BETWEEN CHANGES OF
GIVING SETS FOR THE DRUG PRODUCT
U-271 METHOD OF TREATING TUMORS
U-272 METHOD OF TREATING CARCINOMA
U-273 CUTANEOUS T-CELL LYMPHOMA
U-274 ZANAMIVIR FOR INHALATION
U-275 METHOD OF USE OF THE DRUG SUBSTANCE
U-276 METHOD OF USE OF LEVOBUPIVACAINE
U-277
U-278
NEUROLOGICAL AND OTHER DISORDERS (TREATMENT OF EPILEPSY, BID ORAL DOSING)
METHOD OF USE OF THE INDICATION OF THE DRUG PRODUCT
U-279 METHOD OF USE OF THE APPROVED PRODUCT
U-280 TREATING PRECIPITATED ACUTE URINARY RETENTION WITH FINASTERIDE
U-281
U-282
ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS
METHOD OF TREATING BACTERIAL INFECTIONS
U-283 METHOD FOR TREATING MENOPAUSAL SYMPTOMS IN A POSTMENOPAUSAL FEMALE
U-284
U-285
U-286
MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCIATED
WITH MENOPAUSE, AND VULVAR AND VAGINAL ATROPHY) AND OSTEOPOROSIS
DEPRESSION AND SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA
DEPRESSION
U-287 TREATMENT OR PREVENTION OF OSTEOPOROSIS
U-288 THERAPY OF INFLUENZA
U-289 TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
U-290
U-291
INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS)
INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH
CYCLOSPORIN
U-292 INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH
AZATHIOPRINE
U-293 INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH A
CORTICOSTEROID
U-294 TREATMENT OF HYPERPIGMENTARY DISORDERS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 32 of 62
PATENT USE
U-295 TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
U-296 TREATING MIGRAINE PAIN AND ONE OR MORE OF A CLUSTER OF SYMPTOMS CHARACTERISTIC OF
A MIGRAINE ATTACK SYMPTOMS BEING SELECTED FROM PHOTOPHOBIA, PHONOPHOBIA NAUSEA AND
FUNCTIONAL DISABILITY
U-297 PREVENTION OR TREATMENT OF REVERSIBLE VASOCONSTRICTION BY THE INHALATION OF NITRIC
OXIDE WITH AN OXYGEN CONTAINING GAS
U-298 METHOD OF COMBATING BACTERIA IN A PATIENT
U-299 TREATMENT OF ADENOMATOUS POLYPS
U-300 INDICATED FOR THE REDUCTION OF ELEVATED TOTAL AND LDL CHOLESTEROL LEVELS IN
PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
U-301 USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS AND BIGUANIDES IN THE
TREATMENT OF TYPE II DIABETES
U-302 TO REDUCE THE RISK OF STROKE IN PATIENTS WHO HAVE HAD TRANSIENT ISCHEMIA OF THE
BRAIN OR COMPLETED ISCHEMIC STROKE DUE TO THROMBOSIS
U-303
U-304
METHOD OF USE PATENT-PRODUCT APPROVED FOR TREATMENT OF OSTEOPOROSIS, PAGET'S
DISEASE, PREVENTION AND TREATMENT OF GLUCOCORTICOID INDUCED OSTEOPOROSIS
A METHOD OF TREATMENT OF A CONDITION INVOLVING AN ANTIBODY ANTIGEN REACTION
U-305 METHODS FOR USING THE DRUG PRODUCT
U-306 TREATMENT OF POST-MENOPAUSAL UROGENITAL SYMPTOMS ASSOCIATED WITH ESTROGEN
DEFICIENCY
U-307 CLAIMS AN OLANZAPINE POLYMORPH USEFUL FOR TREATING ANY NUMBER OF LISTED
CONDITIONS, INCLUDING SPECIFIC PSYCHOSES,EMPLOYING OLANZAPINE AS PER THE
INDICATION OF THIS NDA
U-308 CLAIMS A SOLID ORAL FORMULATION INCLUDING TABLETS AND GRANULES OF OLANZAPINE
USEFUL FOR TREATING ANY NUMBER OF LISTED CONDITIONS, INCLUDING SPECIFIC PSYCHOLES,
EMPLOYING OLANZAPINE AS PER THE INDICATIONS OF THIS NDA
U-309 TREATING SJOEGREN SYNDROME
U-310 TREATMENT OF XEROSTOMIA
U-311 HORMONE REPLACEMENT
U-312
U-313
PANIC DISORDER, OBSESSIVE-COMPULSIVE DISORDER, POSTTRAUMATIC STRESS DISORDER
TREATMENT OF CONGESTIVE HEART FAILURE
U-314 METHOD FOR TREATING HYPERPARATHYROIDISM WHICH COMPRISES SUPPRESSING PARATHYROID
ACTIVITY
U-315 METHOD FOR ADMINISTERING DRUG TO GASTROINTESTINAL TRACT
U-316 METHOD OF TREATING A SUBJECT SUFFERING FROM PROSTATE CANCER
U-317 METHOD OF USING TROGLITAZONE TO TREAT PATIENTS HAVING INSULIN RESISTANCE
U-318 TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY
U-319
FREQUENCY, URGENCY, OR URGE INCONTINENCE
TREATMENT OF MICROBIAL INFECTIONS
U-320 INHIBITING OR ELIMINATING ACUTE MYELOID LEUKEMIA
U-321 REDUCTION OF ELEVATED IPTH LEVELS IN THE MGT OF SECONDARY HYPERPARATHYROIDISM IN
PATIENTS UNDERGONG CHRONIC RENAL DIALYSIS
U-322 TREATMENT OF ALZHEIMER'S DEMENTIA
U-323
U-324
USE AS A BILE ACID SEQUESTRANT
METHOD OF TREATING AN ANIMAL, INCLUDING A HUMAN, SUFFERING FROM OR SUSCEPTIBLE TO
PSYCHOSIS OR ACUTE MANIA EMPLOYING OLANZAPINE
U-325 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS,
INCLUDING "BIPOLAR DISORDER NOS" EMPLOYING OLANZAPINE
U-326 METHOD OF TREATING SCHIZOPHRENIA AND BIPOLAR DISORDER
U-327 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED PSYCHOTIC
CONDITONS EMPLOYING OLANZAPINE
U-328 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS
INCLUDING "A PSYCHOTIC CONDITION" EMPLOYING AN OLANZAPINE POLYMORPH
U-329 USE OF AVANDIA AS MONOTHERAPY, IN COMBINATION WITH METFORMIN, AND IN COMBINATION
WITH SULFONYLUREAS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES
MELLITUS
U-330 TREATMENT OF NAUSEA AND VOMITING
U-331 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN
THE EVENING OR AT NIGHT
U-332 TREATMENT OR PREVENTION OF BRONCHOSPASM
U-333 METHOD OF TREATING OCULAR HYPERTENSION
U-334 TREATMENT OF EXCESSIVE FEMALE FACIAL HAIR
U-335 USE OF PRAVASTATIN SODIUM FOR SECONDARY PREVENTION OF CORONARY EVENTS IN MEN AND
WOMEN WHO HAVE HAD A MYOCARDIAL INFARCTION AND HAVE NORMAL CHOLESTEROL LEVELS
U-336 DIAGNOSTIC RADIOIMAGING
U-337 USE OF CARDIOLITE/MIRALUMA KIT FOR THE PREPARATION OF TC99M SESTAMIBI
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 33 of 62
PATENT USE
U-338
U-339
METHODS FOR TREATING DISTURBANCES OF MOOD, DISTURBANCES OF APPETITE, DEPRESSED
MOOD, OR CARBOHYDRATE CRAVING ALL ASSOCIATED WITH PREMENSTRUAL SYNDROME
PREVENTION OF CARDIO-TOXICITY CAUSED BY THE ADMINISTRATION OF DOXORUBICIN
U-340 THE LONG TERM TREATMENT OF GROWTH FAILURE DUE TO LACK OF ADEQUATE ENDOGENOUS
GROWTH HORMONE SECRETION IN CHILDREN
U-341 METHOD FOR ENHANCING THE TREATMENT OF ... LATE LUTEAL PHASE DYSPHORIC DISORDER
U-342 METHOD FOR TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER
U-343
U-344
REDUCTION OF INTESTINAL GAS, CRAMPING AND ANORECTAL IRRITATION
METHOD FOR INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH
ANOTHER HIV PROTEASE INHIBITOR
U-345 RITONAVIR AND ANOTHER HIV PROTEASE INHIBITOR FOR CONCOMITANT ADMINISTRATION FOR
THE TREATMENT OF AN HIV INFECTION
U-346 METHOD FOR INHIBITING CYTOCHROME P450 MONOOXYGENASE WITH RITONAVIR AND A METHOD
FOR IMPROVING THE PHARMCOKINETICS OF A DRUG THAT IS MTABOLIZED BY CYTOCHROME P450
MONOOXYGENASE BY ADMIN THE DRUG AND RITONAVIR
U-347 METHOD OF USE IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS
U-348 METHOD OF USE FOR INHIBITING HIV INFECTION
U-349 METHOD OF USE WHICH IS SUBJECT OF THE APPLICATION
U-350 PREPARATION OF A PHARMACEUTICAL COMPOSITION FOR CONCOMITANT ADMIN WITH A REVERSE
TRANSCRIPTASE INHIBITOR
U-351 INHIBITING PROTEASE WITH LOPINAVIR AND INHIBITING AN HIV INFECTION WITH LOPINAVIIR
U-352 INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH A REVERSE
TRANSCRIPTASE INHIBITOR
U-353 PREVENTION AND TREATMENT OF OSTEOPOROSIS
U-354 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENT-
LIMITING ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY
DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
U-355 METHOD OF ASSISTING PERSON TO QUIT SMOKING...TRANSDERMALLY ADMIN NICOTINE
VIA..PATCH ADHERED TO SKIN AT DOSING RATE APPROX SAME AS ABSORBED FROM SMOKING
U-356 DELIVERING A MEDICINAL AEROSOL FORMULATION USING CFC-FREE PROPELLANT 134A.
U-357 USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF
AGE-RELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED
NEOVASCULATURE IN THE EYE
U-358 DEPRESSION, OBSESSIVE COMPULSIVE DISORDER, PANIC DISORDER AND SOCIAL ANXIETY
DISORDER
U-359 METHOD OF USE OF VISICOL
U-360 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF PATHOLOGICAL
PSYCHOLOGICAL CONDITIONS INCLUDING MENTAL DISORDERS EMPLOYING OLANZAPINE AS PER
THE INDICATION WHICH IS THE SUBJECT MATTER OF THIS SNDA-011
U-361 MANAGEMENT OF ANXIETY DISORDERS AND THE SHORT-TERM RELIEF OF THE SYMPTOMS OF
ANXIETY
U-362 USE OF APPROVED FORMULATIONS TO TREAT ALL APPROVED DISEASE INDICATIONS
U-363 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF PATHOLOGICAL
PSYCHOLOGICAL CONDITIONS THAT RELATE TO THE USE OF A PSYCHOACTIVE SUBSTANCE
EMPLOYING OLANZAPINE AS PER THE INDICATION THE SUBJECT MATTER OF SUPPLEMENT 011
U-364 TREATING A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ANY NUMBER OF LISTED
CONDITIONS INCLUDING PSYCHOSIS, EMPLOYING OLANZAPINE AS PER THE INDICATION WHICH
IS THE SUBJECT MATTER OF THIS SNDA-011
U-365 METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A
U-366
CALCIUM BLOCKING VASODILATOR IN OUR EXTENDED, CONTROLLED RELEASE FORMULATION
METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A
CALCIUM BLOCKING VASODILATOR IN A DELAYED RELEASE FORMULATION
U-367 TREATMENT OF CARDIOVASCULAR DISORDERS
U-368 HEARTBURN
U-369 METHOD OF CONTROLLING AND LOWERING INTRAOCULAR PRESSURE
U-370 INTRAVAGINAL TREATMENT OF VAGINAL INFECTIONS WITH BUFFERED METRONIDAZOLE
COMPOSITIONS
U-371 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA
U-372
CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)
METHOD FOR ADMINISTERING A BENEFICIAL DRUG TO THE GI TRACT OF AN ANIMAL, WHICH
METHOD COMPRISES ADMITTING AN OSMOTIC DEVICE ORALLY INTO THE ANIMAL...
U-373 GENERAL USE CLAIM SUBMITTED FOR 12 NEXIUM PATIENTS STATING "PERTINENT TO THE
CAPSULE FORMULATION FOR NEXIUM AND ITS INDICATIONS FOR THE TREATMENT OF GERD AND
ERADICATION OF H.PYLORI TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
U-374 KIT ADAPTED AND DESIGNED TO PROVIDE BOTH DATA ON THE CURRENT REPRODUCTIVE STATUS
OF A PATIENT AND CONTRACEPTION FOR THOSE WHO ARE NOT PREGNANT, BUT RECENTLY
ENGAGED IN UNPROTECTED SEX
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 34 of 62
PATENT USE
U-375 METHOD OF USING RIBAVIRIN FOR TREATING A DISEASE RESPONSIVE TO RIBAVIRIN, E.G.
HEPATITIS C
U-376 TREATMENT OF INFLUENZA
U-377 METHOD OF TREATING PT WITH CHRONIC HEPATITIS C HAVING HCV GENOTYPE 1 AND VIRAL
LOAD GREATER THAN 2 MILLION COPIES/ML TO ERADICATE DETECTABLE HCV-RNA BY ADMIN
COMBINATION OF RIBAVIRIN AND INTERFERON ALFA-2B FOR A LEAST 24 WEEKS
U-378 METHOD FOR TREATING INCONTINENCE
U-379 METHOD OF TREATING ONYCHROMYCOSIS
U-380 COMBINATIONS OF TAXOL (PACLITAXEL) AND CISPLATIN WHICH ARE SUITABLE FOR THE
TREATMENT OF OVARIAN AND NON-SMALL CELL LUNG CARCINOMAS
U-381 TREATMENT OF HYPERPHOSPHATEMIA
U-382 METHOD OF STABLIZING PROSTAGLANDIN
U-383 METHOD FOR TREATING GLAUCOMA AND OCULAR HYPERTENSION
U-384 TREATMENT OF CMV RETINITIS
U-385 TREATMENT OF PEPTIC ULCERS
U-386 TREATMENT OF PATIENTS SUFFERING FROM A LATE ASTHMATIC REACTION OR LATE PHASE
ASTHMA
U-387 TREATMENT OF PATIENTS WITH RESPIRATORY DISORDERS
U-388 SMOKING CESSATION AID APPLIED TO THE SKIN
U-389 SMOKING CESSATION AID APPLIED TO THE SKIN ON WAKING AND REMOVED PRIOR TO SLEEP
AFTER ABOUT 16 HOURS
U-390
U-391
METHOD OF USING THE DRUG TO TREAT NEUROIMMUNOLOGIC DISEASES (INCLUDING MULTIPLE
SCLEROSIS)
USE OF CASODEX IN COMBINATION WITH LHRH AGONISTS FOR THE TREATMENT OF PROSTATE
CANCER
U-392 TREATMENT OF PATIENTS FOR INFLAMMATION
U-393 MANAGEMENT OF INCONTINENCE, MGT OF HORMONE REPLACEMENT THERAPY, TREATMENT OF
INVOLUNTARY INCONTINENCE, MGT OVERACTIVE BLADDER AND INCREASING COMPLIANCE IN SUCH
PT
U-394 METHOD OF USE OF ALPHAGAN
U-395 METHOD OF USE OF ALPHAGAN P
U-396 METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION
U-397 METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION WITHOUT AN INCREASE IN NAUSEA
U-398 TREATMENT OF GENERALIZED ANXIETY DISORDER
U-399 IN-THE-EYE USE OF CHLORINE DIOXIDE CONTAINING COMPOSITIONS
U-400 USE OF RIBAVIRIN TO INCREASE TYPE 1 CYTOKINE RESPONSE AND SUPPRESS TYPE 2 CYTOKINE
RESP0NSE TO LYMPHOCYTES, INCLUDING METHODS THAT TAKE ADVANTAGE OF SUCH MODULATION
TO TREAT INFECTIONS AND INFESTATIONS
U-401 USE OF LOPINAVIR IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS FOR TREATING
HIV INFECTION AND IN COMBO WITH OTHER HIV PROTEASE INHIBITORS
U-402 TREATMENT OF ACTINIC KERATOSES
U-403 ANTI-ALLERGIC FOR VARIOUS ALLERGIC DISEASES
U-404 TREATMENT OF ALLERGIC CONJUNCTIVITIS
U-405
U-406
U-407
FOR WOMEN WITH SEVERE DIARRHEA-PREDOMINANT IRRITABLE BOWEL SYNDROME (IBS)
METHOD OF USE OF ATOVAQUONE AND PROGUANIL
METHOD OF TREATING OTOPATHY
U-408 FOR INDUCING OVULATION IN CONJUNCTION WITH A GONADOTROPIN RELEASING FACTOR
ANTAGONIST AND RECRUITING OOCYTES FOR IN-VITRO FERTILIZATION
U-409 METHOD OF TREATING INFLAMMATION USING DRUG SUBSTANCE
U-410 METHOD OF REDUCING AMOUNT OF RESPECTIVE ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA
U-411
(INCLUDING PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
METHOD OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA
U-412
(WHICH INCLUDES PIOGLITAZONE) IN COMBINATION WITH AN INSULIN PREPARATION
TREATMENT OF TYPE 2 DIABETES
U-413 USE OF THE ACTIVE INGREDIENT FOR INHIBITING THE BIOSYNTHESIS OF CHOLESTEROL AND
TREATMENT OF ATHEROSCLEROSIS
U-414 A METHOD OF TREATING GLYCOMETABOLISM DISORDERS BY ADMINISTERING AN INSULIN
U-415
SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE
A METHOD FOR REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE)
IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
U-416 A METHOD FOR REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE)
IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 35 of 62
PATENT USE
U-417 COMBINATION USE OF AD-4833 WITH A BIGUANIDE
U-418 A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING A CHEMICAL
COMPOUND HAVING A PARTICULAR FORMULA (WHICH INCLUDES PIOGLITAZONE) IN COMBINATION
WITH AN INSULIN SECRETION ENHANCER
U-419 A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING AN INSULIN
U-420
SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE
METHOD OF TREATMENT OF TYPE II DIABETES
U-421 USE FOR SEDATION
U-422 METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER AND ATTENTION
DEFICIT HYPERACTIVITY DISORDER
U-423
U-424
METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER, ATTENTION DEFICIT
HYPERACTIVITY DISORDER, OR AIDS RELATED DEMENTIA
FOR ONCE DAILY, BOLUS ADMINISTRATION TO A PATIENT IN ORDER TO ENGENDER TREATMENT
FOR A NERVOUS DISORDER FOR SUBSTANTIALLY AN ENTIRE DAY ON A CHRONIC BASIS
U-425 METHOD OF REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMIN TO A DIABETIC BY ADMIN
A CHEMICAL COMPOUND HAVING FORMULA (INCL PIOGLITAZONE) IN COMBINATION WITH AN
INSULIN SECRETION ENHANCER
U-426 PREVENTION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN
STIMULATION
U-427 METHOD OF TREATING ALLERGIC REACTIONS IN MAMMALS
U-428 METHOD OF TREATING ALLERGY IN A MAMMAL USING THIS ACTIVE METABOLITE
U-429 METHOD OF USING DESLORATADINE TO TREAT ALLERGIC RHINITIS
U-430 METHOD OF TREATING A DIABETIC BY ADMINISTERING AN INSULIN SENSITIZER IN
COMBINATION WITH AN INSULIN SECRETION ENHANCER, AND A DRUG PRODUCT C0MPRISING AN
INSULIN SENSITIZER AND AN INSULIN SECRETION ENHANCER
U-431 POSTTRAUMATIC STRESS DISORDER
U-432 REDUCTION OF ATHEROSCLEROTIC EVENTS (MYOCARDIAL INFARCTION, STROKE, AND VASCULAR
DEATH) IN PATIENTS WITH ATHEROSCLEROSIS DOCUMENTED BY RECENT STROKE, RECENT
MYOCARDIAL INFARCTION OR ESTABLISHED PERIPHERAL ARTERIAL DISEASE
U-433 USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN
PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
U-434 CONTROLLED SYMPTOMS OF DIARRHEA, BLOATING PRESSURE AND CRAMPS, COMMONLY REFERRED
TO AS GAS
U-435 A TITRATION DOSING REGIMEN FOR THE TREATMENT OF PAIN USING AN INITIAL DOSE OF
ABOUT 25MG
U-436 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
U-437
U-438
U-439
METHOD OF USE EQUAL TO PROCESS OF PREPARATION
TREATMENT/PREVENTION OF NEURODEGENERATIVE DISEASE
TREATMENT OF OBESITY
U-440 METHOD FOR TRANSDERMAL ADMINISTRATION OF A DRUG THROUGH NON-SCROTAL SKIN USING A
TRANSDERMAL DRUG DELIVERY DEVICE CONTAINING THE DRUG AND HAVING AN ADHESIVE
SURFACE
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
U-442 METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE
OCCURENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID
DRUG
U-443 MANAGEMENT OF MODERATE TO SEVERE PAIN WHEN A CONTINUOUS, AROUND-THE-CLOCK
ANALGESIC IS NEEDED FOR AN EXTENDED PERIOD OF TIME
U-444 TREATMENT OF MIGRAINE
U-445 USE AS AN ANTIMYCOTIC AGENT
U-446 TOPICAL TREATMENT OF OCULAR HYPERTENSION AND GLAUCOMA
U-447 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN
THE EVENING OR AT NIGHT
U-448 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENT-
LIMITING ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY
DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
U-449 USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF
METASTATIC COLORECTAL CANCER WHERE THE DOSE OF LEUCOVORIN IS AT LEAST 200MG PER
U-450
SQUARE METER
INTERMEDIATE REL NICOTINIC ACID FORMULATIONS HAVING UNIQUE URINARY METAB PROFILES
RESULTING FROM ABSORPTION PROFILES OF NICOTINIC ACID FROM THE INTERMEDIATE
U-451
NICOTINIC ACID FORMULATIONS,SUITABLE FOR TX HYPERLIPIDEMIA FOLLOWING QD DOSING
TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER
U-452 USE OF LANSOPRAZOLE FOR COMBATTING DISEASES CAUSED BY THE GENUS CAMPYLOBACTER
U-453
(C.PYLORI=H.PYLORI)
TREATMENT OF PLATELET ASSOCIATED ISCHEMIC DISORDERS
U-454 METHOD OF TX A PT SUSPECTED OF HAVING HEPATITIS C BY ADMIN, IN COMBINATION, A
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 36 of 62
PATENT USE
U-455
CONJUGATE COMPRISING PEG 12000 & INTERFERON ALFA-2B IN AN AMT OF FROM 0.5MCG/KG TO
2MCG/KG, ONCE WEEKLY, AND RIBAVIRIN
TREATMENT OF PULMONARY HYPERTENSION WITH UT-15
U-456 METHOD OF DECREASING THE PRODUCTION OF A-BETA USING A COMPOSITION WHICH DECREASES
BLOOD CHOLESTEROL IN PATIENTS AT RISK OF OR EXHIBITING SYMPTOMS OF ALZHEIMER'S
DISEASE
U-457 METHOD OF TREATING A VAGINAL FUNGAL INFECTION IN A FEMALE HUMAN
U-458 METHOD OF USE OF IMAGENT
U-459 TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER
U-460 METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS
USING SERTRALINE
U-461 METHOD OF TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER (PMDD) USING
SERTRALINE
U-462 SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND ADULT RHEUMATOID ARTHRITIS AND TREATMENT
OF PRIMARY DYSMENORRHEA
U-463 VENOGRAPHY
U-464 PERIPHERAL ARTERIOGRAPHY
U-465 CT IMAGING OF THE HEAD
U-466 TREATMENT OF IRRITABLE BOWEL SYNDROME
U-467 USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE)
INHIBITOR FOR TREATING HYPERTENSION
U-468 METHOD OF USING FEXOFENADINE HCL IN TREATING ALLERGIC RHINITIS
U-469 TREATMENT OF GASTROESOPHAGEAL REFLEX DISEASE (GERD) AND ERADICATION OF H.PYLORI TO
REDUCE RISK OF DUODENAL ULCER RECURRENCE
U-470 THERAPY IN CHRONIC HEPATITIS B VIRUS INFECTION
U-471 METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
U-472 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-
MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES
U-473 TO REDUCE PLASMA CHOLESTEROL LEVELS IN A MAMMAL
U-474 TO REDUCE PLASMA CHOLESTEROL LEVELS BY ADMIN EZETIMIBE IN COMBO WITH CHOLESTEROL
BIOSYNTHESIS INHIB SELECTED FROM GROUP CONSISTING OF HMG COA REDUCTASE INHIBITORS
INCL SIMVASTATIN
U-475 TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO
ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
U-476 METHOD OF TREATING ANDROGEN RESPONSIVE/MEDIATED CONDITION IN MAMMAL BY ADMIN A
SAFE, EFFECTIVE AMOUNT OF DUTASTERIDE OR PHARMACEUTICALLY ACCEPTABLE DERIVATIVE
THEREOF..CONDITIONS INCLUDE BENIGN PROSTATIC HYPERTROPHY
U-477 METHOD OF INHIBITING 5 ALPHA TESTOSTERONE REDUCTASE ENZYME WITH DUTASTERIDE OR ITS
DERIVATIVE AND TREATING ANDROGEN RESPONSIVE/MEDIATED DISEASE INCLUDING BENIGN
PROSTATIC HYPERPLASIA
U-478 METHOD OF TREATING HEPATITIS C VIRAL INFECTION BY CONTINUOUS PARENTERAL ADMIN
INTERFERON ALPHA 2-10 MILLION IU WEEKLY, SUBCUTANEOUSLY, INJECTION OF POLYMER-
INTERFERON ALPHA CONJUGATE-POLYMER IS PEG-INTERFERON IS ALPHA 2B
U-479 METHOD OF USING PEG-INTRON/REBETOL COMBINATION THERAPY AND INTRON/REBETOL
COMBINATION THERAPY
U-480 CONTRAST AGENT FOR MRI
U-481 DISUBSTITUTED ACETYLENES BEARING HETEROAROMATIC AND HETEROBICYCLIC GROUPS HAVING
RETINOID-LIKE ACTIVITY
U-482 METHOD OF IN VITRO FERTILIZATION THERAPY INCLUDING MEANS FOR INDUCING
OVULATION....
U-483 METHOD FOR THE ADMINISTRATION OF DRUGS USING THAT COMPOUND
U-484 METHOD OF TREATING A SKIN DISEASE WITH A CORTICOSTEROID-CONTAINING PHARMACEUTICAL
COMPOSITION
U-485 METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES
U-486
(HERPES ZOSTER AND POST-HERPETIC NEURALGIA)
EXTERNAL PREPARATION FOR APPLICATION TO THE SKIN CONTAINING LIDOCAINE-DRUG
RETAINING LAYER PLACED ON SUPPORT AND COMPRISES ADHESIVE GEL BASE 1-10% BY WEIGHT
OF LIDOCAINE
U-487 METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES
U-488
(HERPES ZOSTER AND POST-HERPETIC NEURALGIA)
METHOD FOR REDUCING THE PAIN ASSOCIATED WITH HERPES-ZOSTER AND POST-HERPETIC
NEURALGIA
U-489 EXPECTORANT
U-490 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A
DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
U-491 METHOD OF DELIVERING A DRUG TO THE LUNG
U-492 METHOD FOR THE TREATMENT OF SKIN, SUFFERING FROM A CONDITION SELECTED FROM A GROUP
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 37 of 62
PATENT USE
CONSISTING OF NONACNE INFLAMMATORY DERMATOSES... COMPRISING APPLYING TO AFFECTED
AREA. A THERAPEUTICALLY EFFECTIVE AMT AZELAIC ACID
U-493 TREATMENT OF TYPE 2 DIABETES MELLITUS
U-494 TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER
U-495 PERITONEAL DIALYSIS SOLUTION
U-496 METHOD FOR TREATING CHRONIC RENAL FAILURE
U-497 RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS
U-498 INTRA-ARTERIAL AND INTRAVENOUS USES OF ULTRAVIST
U-499 METHOD OF USING REBETOL CAPSULES IN COMBINATION WITH A CONJUGATE COMPRISING
POLYETHYLENE GLYCOL(PEG) AND AN ALPHA INTERFERON, INCLUDING, FOR EXAMPLE, PEG-
INTRON POWDER FOR INJECTION
U-500 USE AS AN ANTIHYPERTENSIVE AGENT
U-501
U-502
TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS
PITYRIASIS VERSICOLOR
U-503 GENERATOR MUST BE USED WITH INFUSION SYSTEM SPECIFICALLY LABELED FOR USE WITH
GENERATOR
U-504
U-505
TINEA PEDIS, TINEA CRURIS, TINEA CORPORIS
ULTRASOUND CONTRAST AGENT
U-506
U-507
U-508
PHARM PRODUCT CONTAINER 1ST CHAMBER IS DISPOSED AQUEOUS DILUENT SOL 2ND CHAMBER
PHARM ACTIVE AGENT COMPRISING ACETYLCHOLINE,BUFFER IN 1ST CHAM IS SUFFICIENT TO
BUFFER PH OF MIXED SOL RESULTING MIXTURE OF AQUEOUS DILUENT SOL & PHARM ACTIVE..
ACROMEGALY IN PATIENTS W/INADEQUATE RESPONSE TO SURGERY AND/OR RADIATION THERAPY
AND/OR MEDICAL THERAPIES, OR FOR WHOM THESE THERAPIES ARE NOT APPROPRIATE
METHOD OF RELEASING 17-BETA OESTRADIOL PRECURSOR IN A SUBSTANTIALLY ZERO ORDER
PATTERN FOR AT LEAST THREE WEEKS
U-509 TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO
ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
U-510 TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA
(STAGE IA AND IB) WHO HAVE REFRACTORY OR PERSISTENT DISEASE AFTER OTHER THERAPIES
OR WHO HAVE NOT TOLERATED OTHER THERAPIES
U-511
U-512
U-513
USE OF QUINOLONE COMPOUNDS AGAINST ANAEROBIC PATHOGENIC BACTERIA
USE OF QUINOLONE COMPOUNDS AGAINST ATYPICAL UPPER RESPIRATORY PATHOGENIC BACTERIA
METHODS OF USE OF ANTIMICROBIAL COMPOUNDS AGAINST PATHOGENIC AMYCOPLASMA BACTERIA
U-514 PREVENTION OF OVULATION IN A WOMAN
U-515 TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR
THERAPIES AND HAVE DEMONSTRATED DISEASE PROGRESSION ON THE LAST THERAPY
U-516 METHOD OF TREATING A PSYCHOTIC DISEASE
U-517 STABLE GEL FORMULATION FOR TOPICAL TREATMENT OF SKIN CONDITIONS
U-518 OBSESSIVE COMPULSIVE DISORDER
U-519 POST OPERATIVE NAUSEA AND VOMITING
U-520 PREMENOPAUSAL OSTEOPOROSIS
U-521
U-522
METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B
RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
TREATMENT OF CMV RETINITIS BY INTRAVITREAL ADMIN OF A PHOSPHOROTHIOATE
OLIGONUCLEOTIDE CAPABLE OF HYBRIDIZING WITH CMV MRNA
U-523 METHOD OF TREATING INFECTION BY CRYPTOSPORIDIUM PARVUM IN AN IMMUNOCOMPROMISED
MAMMAL
U-524 METHOD OF TREATING DIARRHEA
U-525 METHOD OF TREATING PARASITIC INFECTIONS
U-526 METHOD OF PROVIDING CONTROLLED RELEASE OF A TREATING AGENT USING A CONTROLLED
RELEASE COMPOSITION
U-527 METHOD OF DELIVERING AN ACTIVE INGREDIENT USING A PROGRESSIVE HYDRATION
BIOADHESIVE
U-528 PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
U-529 ONCE DAILY TREATMENT OF ASTHMA WITH NEBULIZED BUDESONIDE
U-530 TREATMENT OF HERPES ZOSTER, TREATMENT OF GENITAL HERPES, TREATMENT OF COLD SORES,
SUPPRESSION OF GENITAL HERPES IN IMMUNOCOPETENT AND HIV-INFECTED INDIVIDUALS,
REDUCTION OF RISK OF HETEROSEXUAL TRANSMISSION OF GENITAL HERPES
U-531 TREATMENT OF PATIENTS WITH ESSENTIAL HYPERTENSION. MAY BE USED ALONE OR GIVEN
U-532
WITH OTHER CLASSES OF ANTIHYPERTENSIVES, ESPECIALLY THIAZIDE DERIVATIVES
TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD IN PATIENTS REQUIRING MORE THAN ONE
BRONCHO DILATOR
U-533 ERECTILE DYSFUNCTION
U-534 HUMALOG IS AN INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH
DIABETES MELLITUS FOR THE CONTROL OF HYPERGLYCEMIA
U-535 TREATMENT OF SOCIAL ANXIETY DISORDER
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 38 of 62
PATENT USE
U-536 CONTRAST AGENT FOR MAGNETIC RESONACE IMAGING
U-537 TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND
U-538
CARDIAC INSUFFICIENCY, WITH EPLERENONE
FIRST LINE TREATMENT OF SEVERE HYPERTENSION, IN PATIENTS WITH HYPERTENSION SEVERE
ENOUGH THAT THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL EXCEEDS THE RISK
OF INITIATING COMBINATION THERAPY IN THESE PATIENTS
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
U-540 TREATMENT OF FUNGAL INFECTIONS
U-541 METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
U-542 METHOD OF TREATING PATIENT WITH TYPE 2 DIABETES BY ONCE DAILY ADMINISTRATION
U-543 TREATMENT OF SCHIZOPHRENIA
U-544 TREATMENT OF OVERACTIVE BLADDER. TREATMENT OF URINARY INCONTINENCE.
U-545 METHOD FOR THE PREVENTION AND/OR TREATMENT OF THROMBOTIC EPISODES, SUCH AS
MYOCARDIAL INFARCTION, IN A HUMAN PATIENT AND METHOD FOR THE PREVENTION OF VENOUS
THROMBOSIS IN A POSTOPERATIVE HUMAN PATIENT
U-546 USE OF REPAGLINIDE IN COMBINATION WITH METFORMIN TO LOWER BLOOD GLUCOSE
U-547 MAINTENANCE MONOTHERAPY FOR BIPOLAR DISORDER
U-548 A METHOD OF REDUCING FLUSH IN AN INDIVIDUAL BEING TREATED FOR A LIPIDEMIC DISORDER
AND EFFECTIVELY TREATING THE LIPIDEMIC DISORDER
U-549 USE IN THE TREATMENT OF MEN WITH ADVANCED SYMPTOMATIC PROSTATE CANCER
U-550 TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
U-551 METHOD FOR REDUCING TOXICITY OF ALIMTA TREATED PATIENTS BY ADMINISTERING FOLIC
ACID
U-552 TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION
U-553 MANAGEMENT OF PAIN AND DISCOMFORT ASSOCIATED WITH PERIDONTAL SCALING AND ROOT
PLANNING PROCEDURES BY APPLICATION OF AN EUTECTIC MIXTURE OF LOCAL ANESTHETICS TO
PERIDONTAL POCKETS
U-554 TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL
AGENTS
U-555 TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND ACUTE UNCOMPLICATED
PYELONEPHRITIS
U-556
U-557
USE AS ADJUNCT DIAGNOSTIC FOR SERUM THYROGLOBULIN (TG) TESTING
NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
U-558 INDICATED FOR THE RELIEF OF BRONCHOSPASM IN PATIENTS 2-12 YEARS OF AGE WITH ASTHMA
U-559
(REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE)
METHOD OF DECREASING OR REDUCING PARATHYROID HORMONE LEVEL; METHOD OF MODULATING
PARATHYROID HORMONE SECRETION;METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF
REDUCING SERUM IONIZED CALCIUM LEVEL
U-560 METHOD OF DECREASING PARATHYROID HORMONE LEVEL;METHOD OF TREATING
HYPERPARATHYROIDISM
U-561 COSOPT IS INDICATED FOR THE REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS
WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION WHO ARE INSUFFICIENTLY RESPONSIVE
TO BETA BLOCKERS
U-562 TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH AIDS-RELATED KAPOSI'S
SARCOMA
U-563 MARINOL IS INDICATED FOR, INTER ALIA, ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN
PATIENTS WITH AIDS
U-564 TREATMENT OF HIV IN CONCOMITANT THERAPY
U-565 TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS, AND CHRONIC
URTICARIA
U-566 FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED
WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS
AND EMPHYSEMA
U-567 METHOD OF TREATING INFERTILITY
U-568
U-569
METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION
METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION AND
WHEREIN THEREAFTER AN OVULATORY INDUCING AMOUNT OF HCG IS ADMINISTERED
U-570
U-571
METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION AND
WHEREIN THE DAILY AMOUNT OF FSH IS ABOUT 5-10 IU/KG
TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA AND BIPOLAR I MANIA
U-572 INTENSIVE CARE UNIT SEDATION
U-573
U-574
TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL)
PROPHYLAXIS AND TREATMENT OF THE NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS AND
TREATMENT OF THE NASAL SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS IN ADULTS AND
PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
U-575 LOTEMAX OPTHALMIC SUSPENSION IS INDICATED FOR THE TREATMENT OF STEROID RESPONSIVE
CONDITIONS OF THE PALPEBRAL BULBAR CONJUNCTIVA, CORNEA AND ANTERIOR SEGMENT OF THE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 39 of 62
PATENT USE
GLOBE.
U-576 ALREX OPTHALMIC SUSPENSION IS INDICATED FOR THE TEMPORARY RELIEF OF THE SIGNS AND
SYMPTOMS OF SEASONAL ALLERGIC CONJUNCTIVITIS.
U-577 TREATMENT OF BENIGN PROSTATIC HYPERPLASIA WITH FINASTERIDE IN COMBINATION WITH
DOXAZOSIN
U-578 TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA, ACUTE EXACERBATION OF CHRONIC
BRONCHITIS, AND ACUTE BACTERIAL SINUSITIS CAUSED BY SUSCEPTIBLE STRAINS OF
DESIGNATED MICROORGANISMS IN PATIENTS 18 YEARS AND OLDER.
U-579
U-580
TREATMENT OF EPILEPSY AND/OR MIGRAINE.
TREATMENT OF DISORDERS OF THE SEROTONERGIC SYSTEM SUCH AS DEPRESSION AND ANXIETY-
RELATED DISORDERS
U-581 METHOD OF TREATING A CONDITION CAPABLE OF TREATMENT BY INHALATION, E.G. ASTHMA,
COMPRISING ADMINISTRATION OF A FORMULATION CLAIMED IN US PATENT NO. 6743413
U-582 METHOD FOR THE TREATMENT OF A RESPIRATORY DISORDER, E.G. ASTHMA, COMPRISING
ADMINISTERING AN EFFECTIVE AMOUNT OF AN AEROSOL COMPOSITION TO A PATIENT FROM A
METERED DOSE INHALER SYSTEM AS CLAIMED IN US PATENT NO. 6253762
U-583 METHOD FOR THE TREATMENT OF A RESPIRATORY DISORDER, E.G. ASTHMA, COMPRISING
ADMINISTERING TO A PATIENT BY INHALATION, A METERED AEROSOL DOSE OF A DRUG
FORMULATION FROM THE METERED DOSE INHALER SYSTEM CLAIMED IN US 6546928
U-584 SINGLE-DOSE ADMINISTRATION BY THE EPIDURAL ROUTE, AT THE LUMBAR LEVEL, FOR THE
TREATMENT OF PAIN FOLLOWING MAJOR SURGERY
U-585 TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
U-586 AN INTERMEDIATE RELEASE NICOTINIC ACID FORMULATION SUITABLE FOR ORAL
ADMINISTRATION ONCE-A-DAY AS A SINGLE DOSE FOR TREATING HYPERLIPIDEMIA WITHOUT
CAUSING DRUG-INDUCED HEPATOTOXICITY OR ELEVATIONS IN URIC ACID OR GLUCOSE OR BOTH
U-587 USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE)
INHIBITOR (AND OPTIONALLY A DIURETIC) FOR TREATING CONGESTIVE HEART FAILURE AND
HYPERTENSION
U-588 SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER; TREATMENT OF HEARTBURN AND OTHER
SYMPTOMS ASSOCIATED WITH GERD; SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS;
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
U-589 METHOD FOR TREATMENT OF A RESPIRATORY DISORDER, E.G., BRONCHOSPASM, COMPRISING
ADMINISTERING AN EFFECTIVE AMOUNT OF AN AEROSOL COMPOSITION TO A PATIENT FROM A
METERED DOSE INHALER SYSTEM AS CLAIMED IN U.S. PATENT NO. 6131966
U-590 METHOD FOR TREATMENT OF A RESPIRATORY DISORDER,E.G.,BRONCHOSPASM,COMPRISING
ADMINISTERING TO A PATIENT BY ORAL OR NASAL INHALATION A DRUG FORMULATION BY USING
THE METERED DOSE INHALER SYSTEM AS CLAIMED IN US PATENT NO.6532955
U-591 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING A DOSAGE FORM WHICH
PROVIDES ONCE-DAILY ORAL ADMINISTRATION OF A PHENIDATE DRUG
U-592
U-593
U-594
TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA, MIXED HYPERLIPIDEMIA AND/OR HOMOZYGOUS
FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA, MIXED HYPERLIPIDEMIA AND/OR HOMOZYGOUS
FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
U-595 35 MG ORALLY ONCE A WEEK FOR PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN;
35 MG ORALLY ONCE A WEEK FOR TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-596 TREATMENT OF HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER IN POSTMENOPAUSAL
WOMEN WITH DISEASE PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
U-597 FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS
WHO ARE AT HIGH RISK FOR FRACTURE
U-598 PROPHYLACTIC TREATMENT OF MIGRAINE
U-599 METHOD FOR TREATING ALLERGIC CONJUNCTIVITIS
U-600 A METHOD OF TREATING A PATIENT IN NEED OF OPHTHALMIC ANTIMICROBIAL THERAPY WITH
LEVOFLOXACIN
U-601 TREATMENT OF BIPOLAR DISORDER
U-602
U-603
SIGNS AND SYMPTOMS OF OSTEOARTHRITIS, RHEUMATOID ARTHRITIS IN ADULTS, AND/OR
PAUCIARTICULAR OR POLYARTICULAR COURSE JUVENILE RHEUMATOID ARTHRITIS, ACUTE PAIN
IN ADULTS; PRIMARY DYSMENORRHEA; AND/OR ACUTE MIGRAINE ATTACKS IN ADULTS
METHOD OF TREATING INFECTIONS COMPRISING ORALLY ADMINISTERING AN EFFECTIVE AMOUNT
OF THE FDA APPROVED ORAL SUSPENSION
U-604 METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
U-605 TREATMENT OF MAJOR DEPRESSIVE DISORDER(MDD);ALTHOUGH THE MEHCHANISM OF THE
ANTIDEPRESSANT ACTION OF DULOXETINE IN HUMANS IS UNKNOWN, IT IS BELIEVED TO BE
RELATED TO ITS POTENTIATION OF SERATONERGIC AND NORADRENERGIC ACTIVITY IN THE CNS
U-606 USE OF IRINOTECAN IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE
TREATMENT OF METASTATIC COLRECTAL CANCER
U-607 CANCIDAS IS INDICATED FOR EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN
FEBRILE, NEUTROPENIC PATIENTS.
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 40 of 62
PATENT USE
U-608
U-609
USE OF QUINOLONE COMPOUNDS AGAINST PNEUMOCOCCAL PATHOGENIC BACTERIA
USE OF QUINOLONE COMPOUNDS AGAINST QUINOLONE-RESISTANT PNEUMOCOCCAL PATHOGENIC
BACTERIA
U-610 ATROVENT HFA (IPRATROPIUM BROMIDE HFA) INHALATION AEROSOL IS INDICATED AS A
BRONCHODILATOR FOR MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC
U-611
U-612
OBSTRUCTIVE PULMONARY DISEASE, INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA.
METHOD OF USING DESLORATADINE TO TREAT SEASONAL AND PERENNIAL ALLERGIC RHINITIS,
PRURITIS, AND CHRONIC IDIOPATHIC URTICARIA IN PATIENTS 2 YEARS OF AGE AND OLDER
TREATMENT OF SEASONAL ALLERGY SYMPTOMS WITH NASAL CONGESTION IN ADULTS AND
CHILDREN 12 YEARS OF AGE AND OLDER
U-613 REDUCTION OF SERUM PHOSPHATE
U-614 TREATMENT OF SEXUAL DYSFUNCTION
U-615
U-616
ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TOTAL-C, TRIGLYCERIDES AND
APO B, AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED
DYSLIPIDEMIA (TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
MANAGEMENT OF PERSISTENT, MODERATE TO SEVERE PAIN IN PATIENTS REQUIRING
CONTINUOUS, AROUND-THE-CLOCK ANALGESIA WITH A HIGH POTENCY OPIOID FOR AN EXTENDED
PERIOD OF TIME GENERALLY WEEKS TO MONTHS OR LONGER
U-617
U-618
U-619
TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL)
USE OF ROSUVASTATIN CALCIUM TO REDUCE ELEVATED TOTAL-C, LDL-C, APOB, NONHDL-C OR
TG LEVELS; TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR
MIXED DYSLIPIDEMIA; AND TO SLOW THE PROGRESSION OF ATHEROSCLEROSIS.
TREATMENT OF MALIGNANT NEOPLASM
U-620 TREATMENT OF INSOMNIA
U-621 METHOD OF TREATING CANCER
U-622 TREATMENT OF VEGF MEDIATED OCULAR DISEASE.
U-623 SHORT TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
U-624 REDUCTION OF RISK OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
U-625 ALLERGIC RHINITIS OR NASAL POLYPS
U-626 CLOLAR IS INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 TO 21 YEARS OLD WITH
RELAPSED OR REFRACTORY ACUTE LYMPHOBLASTIC LEUKEMIA AFTER AT LEAST TWO PRIOR
REGIMENS
U-627 TREATMENT OF PATIENTS USING EXTENDED-RELEASE CARBAMAZEPINE
U-628 USE OF AVANDIA IN COMBINATION WITH A SULFONYLUREA, AND IN COMBINATION WITH
METFORMIN AND A SULFONYLUREA TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES MELLITUS
U-629 METHOD OF INDUCING A HYPNOTIC OR SEDATIVE EFFECT IN A HUMAN BY ADMINISTERING
ESZOPICLONE
U-630 TREATING URINARY INCONTINENCE BY ADMINISTERING AN EXTENDED-RELEASE FORM OF
DARIFENACIN
U-631 TREATING A DISEASE OF ALTERED MOTILITY OR TONE OF SMOOTH MUSCLE BY ADMINISTERING A
MUSCARINIC RECEPTOR ANTAGONIZING AMOUNT OF DARIFENACIN
U-632 METHOD OF TREATMENT OF CANCER BY ADMINISTERING PARTICLES OF PACLITAXEL THAT HAVE A
PROTEIN COATING
U-633 METHOD FOR TREATMENT OF TUMORS BY ADMINISTERING PACLITAXEL AT A DOSE IN THE RANGE
OF ABOUT 30MG/METER SQUARE TO ABOUT 100MG/METER SQUARE IN A PHARMACEUTICALLY
ACCEPTABLE FORMULATION THAT DOES NOT CONTAIN CREMOPHOR
U-634 METHOD FOR DELIVERY OF A BIOLOGIC (INCLUDING ANTINEOPLASTIC AGENTS) BY
ADMINISTERING TO A PATIENT AN EFFECTIVE AMOUNT OF A BIOLOGIC AS A SOLID OR LIQUID
WITH A POLYMERIC BIOCOMPATIBLE MATERIAL
U-635 TREATMENT OF GERD, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND RISK
REDUCTION OF NSAID ASSOCIATED GASTRIC ULCERS
U-636 TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS
U-637 TREATMENT OF DIABETES WITH AN AMYLIN AGONIST
U-638
U-639
TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, INCLUDING WITH INSULIN
TREATMENT OF A MAMMAL HAVING A NEED OF OR REDUCED ABILITY TO PRODUCE INSULIN WITH
AN INSULIN AND AN AMYLIN SUCH AS PRAMLINTIDE
U-640 USE OF AN AMYLIN AGONIST TO REDUCE GASTRIC MOTILITY AND TREAT POST PRANDIAL
HYPERGYLCEMIA
U-641 USE OF AN AMYLIN AGONIST HAVING SPECIFIED BINDING ACTIVITY TO REDUCE GASTRIC
U-642
MOTILITY, INCLUDING USE THROUGH PARENTERAL ADMINISTRATION
TREATMENT AND PREVENTION OF OSTEOPOROSIS
U-643 THE SHORT TERM TREATMENT (UP TO 10 DAYS) IN PTS HAVING GASTROESOPHAGEAL REFLUX
DISEASE (GERD) AS AN ALTERNATIVE TO ORAL THERAPY IN PTS WHEN THERAPY WITH NEXIUM
CAPSULES IS NOT POSSIBLE OR APPROPRIATE
U-644 TREATMENT OF SEASONAL ALLERGIC RHINITIS
U-645 TREATMENT OF ASTHMA
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PATENT AND EXCLUSIVITY TERMS ADB 41 of 62
PATENT USE
U-646 METHOD OF TREATING OTITIS
U-647 TREATMENT OF OSTEOPOROSIS IN POST MENOPAUSAL WOMEN AND/OR THE TREATMENT TO
INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
U-648 THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND/OR THE TREATMENT TO
INCREASE BONE MASS IN MEN
U-649 A METHOD FOR TREATING A TUMOR DISEASE
U-650 TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT
PATIENTS
U-651
U-652
TREATMENT OF ACUTE PROMYELOCYTIC LEUKEMIA (APL)
TREATMENT OF CARDIAC ARRHYTHMIA
U-653 STIMULATING INSULIN RELEASE BY ADMINISTERING EXENATIDE
U-654
U-655
LOWERING PLASMA GLUCAGON IN A SUBJECT IN NEED THEREOF, INCLUDING ONE WITH TYPE 2
DIABETES, BY ADMINISTERING AN EXEDIN OR ANALOG, SUCH AS EXENDIN-4
TREATMENT OF MILD TO MODERATE ACTIVE CHROHN'S DISEASE INVOLVING THE ILEUM AND/OR
THE ASCENDING COLON AND THE MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE
U-656
CROHN'S DISEASE INVOLVING THE ILEUM AND/OR ASCENDING COLON FOR UP TO 3 MONTHS
REDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN
U-657
EXENDIN, SUCH AS EXENDIN-4
PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-658 TREATMENT OF ADVANCED HORMONE-DEPENDENT BREAST CANCER
U-659 TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC)
AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
U-660 TREATMENT OF HYPERTENSION AND TREATMENT OF HEART FAILURE
U-661 TREATMENT OF SEIZURE DISORDER
U-662 TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-663 THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
U-664
U-665
U-666
TREATMENT OF CONDITIONS FOR WHICH AN ALDOSTERONE RECEPTOR BLOCKER IS INDICATED,
SUCH AS HYPERTENSION, HEART FAILURE, AND POST-MYOCARDIAL INFARCTION
METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
METHOD OF TREATING ADHD
U-667
U-668
MANAGEMENT OF INCONTINENCE; METHOD FOR TREATING INCONTINENCE
LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT
OF PATIENTS WITH DIABETES MELLITUS
U-669 INDICATION OF TYPE II DIABETES
U-670 TREATMENT OF HIV-1 INFECTION BY THE CO-ADMINISTRATION OF TIPRANAVIR AND RITONAVIR.
U-671 PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC
U-672
KIDNEY DISEASE (CKD) STAGE 3 AND 4
TREATMENT OF INFLAMMATION OR AN INFLAMMATION-ASSOCIATED DISORDER
U-673
U-674
METHOD OF TREATMENT WITH ONCE-DAILY DOSES OF 625MG/5ML
METHOD OF TREATING INSOMNIA CHARACHTERIZED BY DIFFICULTY WITH SLEEP ONSET
U-675 PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA; RELIEF OF SYMPTOMS OF ALLERGIC
RHINITIS
U-676 METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-
MODAL OR PULSATILE RELEASE COMPOSITION
U-677 A METHOD OF TREATING DISEASE AMENABLE TO TREATMENT WITH A PHENIDATE DRUG BY ONCE
DAILY ORAL ADMINISTRATION OF AN EXTENDED RELEASE DOSAGE FORM
U-678 METHOD OF TREATING ATTENTION DEFICIT DISORDER AND/OR ATTENTION DEFICIT
HYPERACTIVITY DISORDER
U-679 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
U-680 A METHOD OF TREATING DYSLIPIDEMIA AND DYSLIPOPROTEINEMIA USING A DOSAGE FORM THAT
CAN PROVIDE AN EFFECTIVE AMOUNT OF FENOFIBRATE TO A PATIENT IN A FASTED STATE
WHICH IS AT LEAST 90% OF THE AUC AMOUNT PROVIDED BY THE DOSAGE FORM
U-681 TREATMENT OF PRIMARY IGF-1 DEFICIENCY
U-682
U-683
NON-BENZODIAZEPINE HYPNOTIC AGENT INDICATED FOR TREATMENT OF INSOMNIA,
CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE
PREVENTION OR TREATMENT OF ISCHEMIC HEART DISEASE
U-684 TREATMENT OF UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN
ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER
U-685 EXPECTORANT AND COUGH SUPPRESSANT
U-686 EXPECTORANT AND NASAL DECONGESTANT
U-687 REDUCING FOOD INTAKE IN A SUBJECT WITH TYPE 2 DIABETES BY ADMINISTERING AN
U-688
EXENDIN, SUCH AS EXENDIN-4
TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
U-689 TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA WHOSE DISEASE HAS
NOT RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 42 of 62
PATENT USE
CHEMOTHERAPY REGIMENS
U-690 TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
U-691 USE AS A MONOTHERAPY, IN COMBINATION WITH A SULFONYLUREA, METFORMIN OR INSULIN OR
IN COMBINATION WITH A SULFONYLUREA PLUS METFORMIN TO IMPROVE GLYCEMIC CONTROL IN
PATIENTS WITH TYPE 2 DIABETES MELLITUS
U-692 USE OF VALSARTAN TO REDUCE CARDIOVASCULAR MORTALITY IN CLINICALLY STABLE PATIENTS
WITH LEFT VENTRICULAR FAILURE OR LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL
INFARCTION
U-693 THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE
DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL
CLINICAL RESPONSE.
U-694 LENALIDOMIDE IS AN ANALOGUE OF THALIDOMIDE. THALIDOMIDE IS A KNOWN HUMAN TERATOGEN
THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF LENALIDOMIDE IS TAKEN
U-695
DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY.
TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA AND T-CELL
LYMPHOBLASTIC LYMPHOMA WHOSE DISEASE HAS NOT RESPONDED TO OR HAS RELAPSED
FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY REGIMENS
U-696 TREATMENT OF PATIENTS WITH T-CELL LYMPHOBLASTIC LYMPHOMA WHOSE DISEASE HAS NOT
RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY
REGIMENS
U-697
U-698
A METHOD OF USING RINFABATE RECOMBINANT (RHIGFBP-3) WITH MECASERMIN RECOMBINANT
(RHIGF-1) TO PROMOTE LINEAR GROWTH IN THE TRATMENT OF PRIMARY IGF-1 DEFICIENCY
METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR
INTRAVENOUS TREATMENT OF PATEINTS WITH EUVOLEMIC HYPONATREMIA
U-699 NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
U-700 TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-701
U-702
TREATMENT OF HYPERCHOLESTEROLEMIA AND/OR HYPERTRIGLYCERIDEMIA
TOPICAL AEROSOL HAIR REGROWTH TREATMENT
U-703 TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL
TUMOR AND RENAL CELL CARCINOMA WITH SUNITINIB
U-704 METHOD OF ADMINISTERING INSULIN VIA INHALATION
U-705 TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE
U-706 TREATMENT OF BENIGN PROSTATIC HYPERPLASIA
U-707 ALLERGIC RHINITIS
U-708 TREATMENT OF CHRONIC NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE
EYE
U-709 METHOD OF COMBATING BACTERIA IN A PATIENT
U-710 A METHOD OF TREATING RESPIRATORY DISORDERS, E.G., ASTHMA, WHICH COMPRISES
ADMINISTRATION BY INHALATION OF AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL
FORMULATION AS CLAIMED IN US PATENT NO. 5658549
U-711 ACUTE AND LONGER-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER
U-712
U-713
A METHOD OF USING A NICOTINIC ACID FORMULATION TO REDUCE ELEVATED TC, LDL-C AND TG
LEVELS, AND RAISE HDL-C LEVELS IN PATIENTS WITH HYPERLIPIDEMIA
TREATMENT OF MILD TO MODERATE DEMENTIA OF THE ALZHEIMER'S TYPE
U-714 TOPICAL TREATMENT OF INTERDIGITAL TINEA PEDIS AND TINEA CORPORIS DUE TO
U-715
TRICHOPHYTON RUBRUM, TRICHOPHYTON MENTAGROPHYTES OR EPIDERMOPHYTON FLOCCOSUM
FOR CLEANSING THE BOWEL IN PREPARATION FOR COLONOSCOPY, IN ADULTS 18 YEARS OF AGE
OR OLDER
U-716 THE TREATMENT OR PREVENTION OF BRONCHOSPASM IN ADULTS AND CHILDREN 4 YEARS OF AGE
AND OLDER WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE AND THE PREVENTION OF
EXERCISED-INDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
U-717 METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
U-718 TREATMENT OF FUNGAL INFECTIONS
U-719 TREATENT OF PSYCHOSIS
U-720 TREATMENT OF NEUROLEPTIC DISEASES
U-721 TREATMENT OF INFLUENZA
U-722 PROPHYLAXIS OF INFLUENZA
U-723 PROPHYLACTIC TREATMENT OF MIGRAINE
U-724 METHOD OF TREATING SEIZURES
U-725 ALLERGIC RHINITIS AND URTICARIA
U-726 ALLERGIC RHINITIS
U-727
U-728
FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
METHOD FOR TREATING BACTERIAL INFECTION
U-729 TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), RISK-REDUCTION OF NSAID-
ASSOCIATED GASTRIC ULCER, H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL
ULCER RECURRENCE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 43 of 62
PATENT USE
U-730 USE AS A NASAL SPRAY FOR TREATMENT OF THE SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
AND VASOMOTOR RHINITIS
U-731 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS
WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
U-732 ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA
U-733
NODOSUM LEPROSUM (ENL)
MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS
OF ENL RECURRENCE
U-734 FIRST LINE THERAPY FOR TYPE 2 DIABETES MELLITUS
U-735 METHOD OF TREATING CHRONIC IRON OVERLOAD
U-736 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
U-737 DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
U-738 INDICATED FOR THE LONG-TERM, TWICE-DAILY MAINTENANCE TREATMENT OF ASTHMA IN
PATIENTS 12 YEARS OF AGE OR OLDER
U-739 METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMALIAN SUBJECT
U-740 FOR THE TREATMENT OF PATIENTS WITH PRIMARY BILIARY CIRRHOSIS
U-741 COMBINATION THERAPY WITH CISPLATIN FOR THE TREATMENT OF LATE STAGE CERVICAL CANCER
U-742
U-743
TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS.
ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
U-744 TREATMENT OF HIV INFECTION IN ANTIRETROVIRAL TREATMENT-EXPERIENCED ADULT PATIENTS
U-745 TREATMENT OR PREVENTION OF EMESIS
U-746 PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC
AGENT
U-747 PREVENTION OR TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
U-748 A METHOD FOR THE TREATMENT OF A PROTEIN TYROSINE KINASE-ASSOCIATED DISORDER
U-749 METHOD OF CONTRACEPTION
U-750 TREATMENT OF HIV-1 INFECTION IN ADULTS
U-751 ONCE DAILY DOSING OF BUDESONIDE VIA NEBULIZER FOR THE TREATMENT OF ASTHMA
U-752 SUNSCREEN
U-753 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH
TYPE 2 DIABETES
U-754 USE FOR THE LONG-TERM MAINTENANCE TREATMENT OF ASTHMA
U-755
U-756
TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN
PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH
OSTEOPOROSIS
U-757
U-758
USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL
TREATMENT OF SYMPTOMS OF PREMENSTRUAL DYSPHORIC DISORDER
U-759 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
U-760 PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS AND TREATMENT OF
OROPHARYNGEAL CANDIDAIASIS
U-761 TREATMENT OF SCHIZOPHRENIA INCLUDING MAINTAINING STABILITY IN PATIENTS WITH
SCHIZOPHRENIA
U-762 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
U-763 ADMINISTRATION OF ARIPIPRAZOLE BY INJECTION
U-764 TREATMENT OF SCHIZOPHRENIA
U-765 METHOD OF TREATING ALLERGIC CONJUNCTIVITIS
U-766 TREATMENT OF SEIZURES
U-767 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
U-768 A METHOD OF REDUCING THE CAPACITY OF EXTENDED RELEASE NICOTINIC ACID TO PROVOKE A
FLUSHING REACTION BY PRETREATING AN INDIVIDUAL WITH A FLUSH INHIBITING AGENT PRIOR
TO THE ADMINISTRATION OF THE EXTENDED RELEASE NICOTINIC ACID
U-769 REVLIMID (LENALIDOMIDE) IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE
TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEASET ONE PRIOR
THERAPY
U-770 LONG-TERM TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS
U-771
U-772
METHOD FOR THE TREATMENT OF DIABETES MELLITUS, SUCH AS TYPE 1 DIABETES MELLITUS OR
TYPE 2 DIABETES MELITUS, IN A HUMAN PATIENT
RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN CHILDREN 2 TO 11
YEARS AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH UNCOMPLICATED SKIN
MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN CHILDREN 6 MONTHS TO 11 YEARS
U-773 PATHOLOGICAL HYPERSECRETORY CONDITIONS
U-774 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASTE-IV INHIBITOR
U-775 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 44 of 62
PATENT USE
U-776 TREATMENT OF CUTANEOUS MANIFESTATION IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA
(CTCL) WHO HAVE PROGRESSIVE, PERSISTENT OR RECURRENT DISEASE ON OR FOLLOWING TWO
SYSTEMIC THERAPIES.
U-777 DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE
U-778 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATEINTS WITH OPEN ANGLE GLAUCOMA OR
OCULAR HYPERTENSION
U-779 A METHOD FOR TREATMENT OF A CANCER, WHEREIN THE CANCER IS CHRONIC MYELOGENOUS
LEUKEMIA
U-780 A METHOD FOR THE TREATMENT OF CANCER
U-781 FOR TREATMENT OF ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE NAIVE TO
PHARMACOLOGIC THERAPY
U-782 TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL
REPLICATION AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM
U-783
AMINOTRANSFERASES (ALT OR AST) OR HISTOLOGICALLY ACTIVE DISEASE
DESONATE GEL IS INDICATED FOR THE TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS
IN PATIENTS 3 MONTHS OF AGE AND OLDER
U-784
U-785
TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)
USE AS REPLACEMENT SOLUTION, HEMOFILTRATION SOLUTION OR HEMODIAFILTRATION SOLUTION
IN CONTINUOUS RENAL REPLACEMENT THERAPY
U-786 PRODUCT IS APPROVED FOR THE TOPICAL TREATMENT OF TINEA PEDIS
U-787 MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND PEDIATRIC
PATIENTS SIX YEARS OF AGE OR OLDER, INCLUDING PATIENTS REQUIRING ORAL
CORTICOSTEROID THERAPY FOR ASTHMA
U-788 METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS
USING PAROXETINE
U-789 TREATMENT OF KNOWN OR SUSPECTED CYANIDE POISONING
U-790 FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS
WHO ARE AT RISK FOR FRACTURE. FORTEO CAN BE USED BY PEOPLE WHO HAVE HAD A FRACTURE
RELATED TO OSTEOPOROSIS
U-791
U-792
GLEEVEC IS ALSO INDICATED FOR THE TREATMENT OF PATIENTS WITH KIT (CD117) POSITIVE
UNRESECTABLE AND/OR METASTATIC MALIGNANT GASTROINTESTINAL STROMAL TUMORS (GIST)
TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
U-793 FOR THE LONG TERM TREATMENT, TWICE DAILY (MORNING AND EVENING) MAINTENANCE
TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY
U-794
DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS
WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN
USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
U-795 METHOD FOR INHIBITING NOREPINEPHRINE UPTAKE
U-796 METHOD OF TREATING DEPRESSION
U-797 METHOD OF TREATING ANXIETY
U-798 TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN BY ONCE-MONTHLY
ORAL ADMINISTRATION OF IBANDRONATE SODIUM MONOHYDRATE EQUIVALENT TO 150MG OF
IBANDRONIC ACID
U-799 METHOD FOR INHIBITING SEROTONIN UPTAKE
U-800 TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS
OVEREXPRESS HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A
TAXANE AND TRASTUZUMAB
U-801 METHOD OF TREATING CANCER
U-802 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR
U-803 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN
U-804 TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY
U-805 TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES
U-806 INTRATHECAL TREATMENT OF LYMPHOMATOUS MENINGITIS
U-807 PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION
U-808 THE TREATMENT OF THE SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN
PATIENTS 2 YEARS OF AGE AND OLDER
U-809 TREATMENT OF CHRONIC IDIOPATHIC URTICARIA
U-810 METHOD OF TREATMENT TO ALLEVIATE INFLAMMATION OF THE EYE
U-811 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS AND
TREATMENT OF THE UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA
U-812 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
U-813 MAINTENANCE TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE
U-814
PULMONARY DISEASE (COPD)
TREATMENT OF SCHIZOPHRENIA
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 45 of 62
PATENT USE
U-815
U-816
U-817
TREATS COLD SORES/FEVER BLISTERS ON THE FACE OR LIPS. SHORTENS HEALING TIME AND
DURATION OF SYMPTOMS: TINGLING, PAIN, BURNING AND/OR ITCHING
DEPRESSION, PANIC DISORDER, PREMENSTRUAL DISORDERS AND SOCIAL ANXIETY DISORDER
NASAL ADMINISTRATION OF CYANOCOBALAMIN
U-818 TOPICAL TREATMENT OF ACNE VULGARIS
U-819 MANAGEMENT OF FIBROMYALGIA
U-820 IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE SLEEPINESS ASSOCIATED WITH
NARCOLEPSY, OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME, AND SHIFT WORK SLEEP
DISORDER
U-821 METHOD OF INHIBITING ENTHOTHELIN RECEPTORS BY ADMINISTERING AMBRISENTAN TO A
PATIENT TO TREAT PULMONARY ARTERIAL HYPERTENSION.
U-822 USE IN LIPID MANAGEMENT
U-823 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS AND FOR THE
TREATMENT OF UNCOMPLCATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN
CHILDREN 6 TO 11 YEARS OF AGE
U-824 METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1
U-825 USE FOR PREVENTION OF BREAST CANCER
U-826 RELIEF OF MODERATE TO SEVERE PAIN
U-827
U-828
USE FOR TREATMENT OF DIABETES, PARTICULARLY TYPE 2 DIABETES
PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD
OF CONTRACEPTION
U-829 TREATMENT OF EXTRAVASATION RESULTING FROM IV ANTHRACYCLINE CHEMOTHERAPY
U-830 TREATMENT OF RELAPSED SMALL CELL LUNG CANCER
U-831 METHOD OF ADMINISTERING LANREOTIDE ACETATE
U-832 ZINGO IS INDICATED FOR THE USE ON INTACT SKIN TO PROVIDE LOCAL ANALGESIA PRIOR TO
VENIPUNCTURE OR INTRAVENOUS CANNULATION.
U-833 METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE
AND ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.25% BY WEIGHT OF
ROPIVACAINE
U-834 INVIRASE IN COMBINATION WITH RITONAVIR AND OTHER ANTIRETROVIRAL AGENTS IS
INDICATED FOR THE TREATMENT OF HIV INFECTION
U-835 RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF ATOPIC DERMATITIS IN
PATIENTS ONE YEAR OF AGE OR OLDER
U-836 A METHOD FOR THE TREATMENT OF LEUKEMIAS
U-837 GASTROINTESTINAL LAVAGE INDICATED FOR CLEANSING OF THE COLON AS A PREPARATION FOR
COLONOSCOPY IN ADULTS
U-838 METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE
AND ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.5% BY WEIGHT OF ROPIVACAINE
U-839
U-840
TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
TREATMENT FOR TYPE 2 DIABETES MELLITUS
U-841 INDICATED FOR THE LONG-TERM, MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS
OF AGE AND OLDER
U-842
U-843
INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
METHOD FOR ADMINISTRATION OF TESTOSTERONE
U-844 PREFEST IS INDICATED IN WOMEN WHO HAVE A UTERUS FOR THE TREATMENT OF MODERATE TO
U-845
SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE; TREATMENT OF VULVAR AND
VAGINAL ATROPHY; PREVENTION OF OSTEOPOROSIS
TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA
PERITONITIS AND ABCESSES
U-846
U-847
USE FOR DELINEATION (VISUALIZATION) DURING A VITRECTOMY SURGICAL PROCEDURE
ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TRIGLYCERIDES AND APO B, AND
INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA
U-848
(TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
U-849 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR
OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO
INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE
TWICE DAILY
U-850 PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC
AGENT
U-851 TREATMENT OF TYPE 2 DIABETES MELLITUS
U-852 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
U-853 TREATMENT OR PREVENTION OF EMESIS
U-854
U-855
PREVENTION OF CMV DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS TRANSPLANT
PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE)
METHOD TO INDUCE NATRIURESIS, DIURESIS AND/OR VASODILATION
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 46 of 62
PATENT USE
U-856 SUPPORT EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS
LUTEAL FUNCTION AS PART OF AN ASSISTED REPORDUCTIVE TECHNOLOGY (ART) TREATMENT
PROGRAM FOR INFERTILE WOMEN
U-857 INHIBITION OF TRANSPLANT REJECTION
U-858
U-859
PEDIATRIC USE AGED 1-11 YEARS, GERD AND EROSIVE ESOPHAGITIS
EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS
IN PATIENTS WITH GERD
U-860
U-861
FOR THE APPROVED USES AND CONDITIONS OF USE, INCLUDING DEPRESSION
RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID
RESPONSIVE DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER
U-862
U-863
ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A)
LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED
DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA
TAKING ASPIRIN OR NON-STEROIDAL ANTI-INFLAMMATORY MEDICATIONS APPROXIMATELY 30
MINUTES BEFORE DOSING CAN MINIMIZE FLUSHING, A COMMON SIDE EFFECT OF NIACIN
THERAPY
U-864
U-865
PEDIATRIC USE AGES 1-2 YEARS, GERD AND EROSIVE ESOPHAGITIS
TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND A HIGH RISK FOR BONE FRACTURE BY
REDUCING THE RISK OF VERTEBRAL AND NONVERTEBRAL BONE FRACTURE
U-866 THE LABEL REFERENCES THE EFFECTS OF THE ACTIVE INGREDIENT OF REVLIMID UPON
CYTOKINES
U-867 TREATMENT OF MIGRAINE
U-868 METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR
INTRAVENOUS TREATMENT OF PATIENTS WITH HYPERVOLEMIC HYPONATREMIA
U-869 METHOD FOR STIMULATING CORONOARY VASODILATION FOR PURPOSES OF IMAGING THE HEART
U-870 METHOD OF PRODUCING CORONARY VASODILATION WITHOUT PERIPHERAL VASODILATION
U-871
U-872
METHOD OF REDUCING RISK OF MYOCARDIAL INFARCTION, STROKE AND DEATH
TWICE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC
OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA.
TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
U-873 METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME BY
U-874
OPENING CHLORIDE CHANNELS (CIC)
METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME
U-875 FIRST-LINE TREATMENT OF LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC
U-876
CANCER, IN COMBINATION WITH GEMCITABINE
TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
U-877 FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PEPTIC ULCER
U-878 A METHOD FOR BINDING A PERIPHERAL OPIOID RECEPTOR
U-879 A METHOD OF TREATING OR PREVENTING ILEUS
U-880 ENDOMETRIN IS A PROGESTERONE INDICATED TO SUPPORT EMBRYO IMPLANTATION AND EARLY
PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED
U-881
REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN
TREATMENT OF NON-SMALL CELL LUNG CANCER
U-882
U-883
MANAGEMENT OF FIBROMYALGIA (FM)
TREATMENT OF GASTROINTESTINAL STROMAL TUMOR WITH SUNITINIB
U-884 TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
U-885 TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR
THERAPY
U-886
U-887
ADMINISTERING DESLORATADINE TO TREAT THE SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS,
SEASONAL ALLERGIC RHINITIS, OR CHRONIC IDIOPATHIC URTICARIA
TREATMENT AND PREVENTION OF OSTEOPOROSIS
U-888 FEMALE HORMONE REPLACEMENT THERAPY FOR POSTMENOPAUSAL WOMEN
U-889
U-890
MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCCIATED
WITH MENOPAUSE)
REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
U-891 USE AS AN INTRAOCULAR IRRIGATING SOLUTION DURING SURGICAL PROCEDURES INVOLVING
PERFUSION OF THE EYE
U-892 TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA
U-893
(CTCL)
CLEVIPREX IS A DIHYDROPYRIDINE CALCIUM CHANNEL BLOCKER INDICATED FOR THE REDUCTION
OF BLOOD PRESSURE WHEN ORAL THERAPY IS NOT FEASIBLE OR NOT DESIRABLE
U-894 TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER
U-895 TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
U-896 TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS
AND CHILDREN TWO YEARS OF AGE AND OLDER
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 47 of 62
PATENT USE
U-897 METHOD OF TREATING TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS
PYOGENES IN A ONCE-A-DAY AMOXICILLIN PRODUCT
U-898 USE OF GLUTAMINE TOGETHER WITH GROWTH HORMONE FOR THE TREATMENT OF PATIENTS WITH
SHORT BOWEL SYNDROME
U-899 USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS
WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
U-900 INTEGRASE INHIBITION FOR THE TREATMENT OF HIV INFECTION
U-901 PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
U-902 USE IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA
U-903
U-904
(BPH)
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN ADULT PATIENTS
TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
U-905
U-906
U-907
TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE,
SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
PROPHYLAXIS OF ORGAN REJECTION IN KIDNEY, LIVER AND HEART ALLOGENIC TRANSPLANTS;
TREATMENT OF PATIENTS WITH SEVERE ACTIVE, RHEUMATOID ARTHRITIS; TREATMENT OF
ADULT, NONIMMUNOCOMPROMISED PATIENTS WITH SEVERE, RECALCITRANT, PLAQUE PSORIASIS
FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS IN SUBJECTS 18 YEARS OF AGE
AND OLDER
U-908 PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS RECEIVING ALLOGENEIC RENAL TRANSPLANTS
U-909 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
U-910 TREATMENT OF METASTATIC CARCINOMA OF THE OVARY AFTER FAILURE OF INITIAL OR
U-911
SUBSEQUENT CHEMOTHERAPY
METHOD OF TREATING, AS ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT
WITH EPILEPSY AGED 17 YEARS AND OLDER WHEN ORAL TREATMENT IS TEMPORARILY NOT
FEASIBLE
U-912 SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER
PROCEDURES
U-913
U-914
TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE,
URGENCY, AND FREQUENCY
METHOD OF TREATING, AS ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT
WITH EPILEPSY AGED 17 YEARS AND OLDER
U-915 TREATMENT OF MUSCULOSKELETAL CONDITIONS
U-916 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
U-917 TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
U-918 TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-
RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET
U-919 FOR THE TREATMENT OF DERMATITIS
U-920 STEROID-RESPONSIVE INFLAMMATORY OCULAR CONDITIONS FOR WHICH A CORTICOSTEROID IS
INDICATED AND WHERE SUPERFICIAL BACTERIAL OCULAR INFECTION OR A RISK OF BACTERIAL
OCULAR INFECTION EXISTS
U-921 TREATMENT OF ACNE VULGARIS
U-922 FOR THE TREATMENT OF FUNGAL INFECTIONS
U-923 METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION
U-924 TREATMENT OF MILD TO MODERATE INFECTION CAUSED ABY SUSCEPTIBLE STRAINS
U-925
U-926
U-927
TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTILES) OF ROSACEA
MGT SPECIFIC BACTERIAL INFECTIONS. TREATMENT PTS W/ COMMUNITY ACQUIRED PNEUMONIA
OR BACTERIAL SINUSITIS DUE TO CONFIRMED, OR SUSPECTED B-LACTAMASE PRODUCING
PATHOGENS & S. PNEUMONIAE WITH REDUCED SUSCEPTIBILITY TO PENICILLIN (MIC=2MC/ML)
METHOD FOR INCREASING TEAR PRODUCTION
U-928 TREATMENT OF BACTERIAL INFECTIOUS DISEASE
U-929 TREATMENT OF OBSESSIVE COMPULSIVE DISORDER TREATABLE WITH AN SSRI
U-930
U-931
TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
RELIEF OF MODERATE TO SEVERE ACUTE PAIN
U-932 PYLERA CAPSULES, IN COMBINATION WITH OMEPRAZOLE ARE INDICATED FOR THE TREATMENT OF
PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL ULCER DISEASE TO
ERADICATE H. PYLORI
U-933 FOR THE TREATMENT OF PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL
ULCER DISEASE TO ERADICATE H. PYLORI. THE ERADICATION OF HELICOBACTER PYLORI HAS
BEEN SHOWN TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
U-934 IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE
HEMATOPOIETIC STEM CELL TO THE PERIPHERAL BLOOD FOR COLLECTION AND SUBSEQUENT
AUTOLOGOUS TRANSPLANTATION WITH NON-HODGKINS LYMPHOMA AND MULTIPLE MYELOMA
U-935 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF
AGE AND OLDER
U-936 USE IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 48 of 62
PATENT USE
HEMATOPOIETIC STEM CELLS TO PERIPHERAL BLOOD FOR COLLECTION & SUBSEQUENT
AUTOLOGOUS TRANSPLANTATION IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA & MULTIPLE
MYELOMA
U-937 TREATMENT OF PROSTATE CANCER
U-938 TREATMENT OF HAIR LOSS AND HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR
U-939
GROWTH INCLUDING LENGTH, THICKNESS AND DARKNESS
TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING AND STIMULATING THEIR
U-940
GROWTH INCLUDING LENGTH, THICKNESS AND DARKNESS
METHOD TO TREAT AIDS-RELATED KAPOSI'S SARCOMA
U-941 METHOD TO TREAT OVARIAN CANCER
U-942 METHOD TO TREAT MULTIPLE MYELOMA
U-943 GNRH ANTAGONIST INDICATED FOR TREATMENT OF PATIENTS WITH ADVANCED PROSTATE CANCER
U-944
U-945
U-946
TREATMENT OF PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
SEDATIVE-HYPNOTIC AGENT INDICATED FOR MONITORED ANESTHESIA CARE (MAC) SEDATION
TREATMENT OF BREAST CANCER
U-947 WHEN PATIENTS ARE UNABLE TO TAKE THE ORAL FORMULATIONS, PREVACID IV, FOR INJECTION
IS INDICATED AS AN ALTERNATIVE FOR THE SHORT-TERM TREATMENT (UP TO 7 DAYS) OF ALL
GRADES OF EROSIVE ESOPHAGITIS
U-948 TREATMENT OF DIABETES MELLITUS
U-949
U-950
U-951
HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE
U-952
(GERD) FOR 4 WEEKS
USE AS AN ANALGESIC
U-953 METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION
U-954 CHRONIC MANAGEMENT OF HYPERURICEMIA IN PATIENTS WITH GOUT. NOT RECOMMENDED FOR THE
TREATMENT OF ASYMPTOMATIC HYPERURICEMIA
U-955 PROPHYLACTIC TREATMENT OF MIGRAINE
U-956 TREATMENT OF PATIENTS WITH H. PYLORI INFECTION AND DUODENAL ULCER DISEASE
U-957 A METHOD OF TREATING CANCER IN A PATIENT COMPRISING ADMINISTERING IXABEPILONE OR
PHARMACEUTICAL COMPOSITIONS COMPRISING IXABEPILONE
U-958 METHOD OF TREATING PATIENT COMPRISING MIXING FIRST AND SECOND VIALS OF PRODUCT
COMPRISING LYOPHILIZED IXABEPILONE TO PROVIDE AN EPOTHILONE ANALOG SOLUTION,
DILUTING SOLUTION WITH A SUITABLE DILUENT TO PREPARE INTRAVENOUS FORMULATION FOR
PT
U-959
U-960
METHOD OF TREATING CANCER, IV ADMIN, LYOPHYLIZED IXABEPILONE DILUTED, EVERY WEEK
OR 3 WEEKS; LYOPHILIZED IXABEPILONE WITH SOLVENT(DEHYDRATED ETHANOL) DILUTED TO
CONCENTRATION OF 0.1MG/ML TO 0.9MG/ML
METHOD OF TREATING CANCER IN A PATIENT COMPRISING INTRAVENOUSLY ADMINISTERING TO
THE PATIENT IXABEPILONE DILUTED IN A PARENTERAL DILUENT
U-961 METHOD OF TREATING BREAST CANCER BY ADMINISTERING IXABEPILONE; A METHOD OF
TREATING A CANCER RESPONSIBLE TO MICROTUBULE STABILIZATION BY ADMINISTERING
IXABEPILONE
U-962 SYMBYAX IS INDICATED FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN
ADULTS
U-963 PROZAC AND OLANZAPINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT
RESISTANT DEPRESSION IN ADULTS
U-964 ZYPREXA ZYDIS AND FLUOXETINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT
RESISTANT DEPRESSION IN ADULTS
U-965 USE OF IXABEPILONE IN COMBINATION WITH CAPECITABINE IN TREATMENT OF METASTASIS
BREAST CANCER
U-966
U-967
TREATMENT OF ASTHMA (MAINTENANCE AND PROPHYLACTIC THERAPY)
A METHOD OF REVERSING SOFT-TISSUE ANESTHESIA I.E. ANESTHESIA OF THE LIP AND
TONGUE, AND THE ASSOCIATED FUNCTIONAL DEFICITS RESULTING FROM AN INTRAORAL
SUBMUCOSAL INJECTION OF A LOCAL ANESTHETIC
U-968 A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
U-969 TREATMENT OF MIGRAINE
U-970 TOPICAL TREATMENT OF LICE INFESTATIONS
U-971 INDICATED FOR THE ACUTE TREATMENT OF ADULTS WITH SCHIZOPHRENIA
U-972 MONOTHERAPY OR AS ADJUNCTIVE THERAPY TO LITHIUM OR VALPROATE FOR THE MAINTENANCE
TREATMENT OF BIPOLAR I DISORDER
U-973 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2
DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO
U-974
HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE
ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
U-975 TREATMENT OF PULMONARY HYPERTENSION
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 49 of 62
PATENT USE
U-976 IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
U-977 TREATMENT OF ACUTE, UNCOMPLICATED MALARIA INFECTION DUE TO PLASMODIUM FALCIPARUM
IN PATIENTS OF 5KG BODYWEIGHT AND ABOVE
U-978 METHOD OF TREATING HYPONATREMIA
U-979 RELIEF OF MUSCLE SPASM
U-980 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE
PAIN
U-981
U-982
MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN
ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY,
ANALGESIC, AND ANTIPYRETIC ACTIVITY
A METHOD OF TREATING OSTEOPOROSIS
U-983 METHOD OF TREATING OSTEOPOROSIS IN A POST-MENOPAUSAL WOMAN AT RISK FOR FRACTURE
U-984 METHOD FOR THE TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND AT RISK FOR BONE
FRACTURE
U-985
U-986
U-987
TREATMENT OF MACULAR EDEMA FOLLOWING BRANCH RETINAL VEIN OCCLUSION (BRVO) OR
CENTRAL RETINAL VEIN OCCLUSION (CRVO)
TREATMENT OF PATIENTS INFECTED WITH PEDICULUS HUMANUS CAPITIS (HEAD LICE AND THEIR
OVA) OF THE SCALP HAIR
TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH CHRONIC KIDNEY DISEASE
ON DIALYSIS
U-988 TREATMENT OF RHINITIS COMPRISING THE NASAL APPLICATION OF A PHARMACEUTICAL
FORMULATION AS CLAIMED IN US PATENT 7541350
U-989 FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM
HYPERPHENYLALANINEMIA
U-990 TREATMENT OF PROTOZOAL INFECTION
U-991 TREATMENT OR PROPHYLAXIS OF THROMBOSIS OR EMBOLISMS
U-992 REDUCTION OF THE RISK OF CARDIOVASCULAR HOSPITALIZATION
U-993 METHOD OF TREATING INFERTILITY
U-994 METHOD OF TREATMENT OF OSTEOPOROSIS WHEREIN THE OSTEOPOROSIS IS STEROID-INDUCED
U-995 METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN
U-996 AN ADJUNCTIVE THERAPY TO DIET TO REDUCT ELEVATED TOTAL CHLORESTEROL (TC), LOW-
DENSITY LIPOPROTEIN CHOLESTEROL, APOLIPOPROTEIN B, TRIGLYCERIDES, AND TO INCREASE
HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIX DYSLIPIDEMIA
U-997 TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
U-998 ADJUNCITVE THERAPY TO DIET TO REDUCE ELEVATED TOTAL CHOLESTEROL, LOW-DENSITY
LIPOPROTEIN CHOLESTEROL, APOLIPOPRTEIN B, TRIGLYCERIDES AND TO INCREASE HDL-C IN
ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA
U-999 TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
U-1000 ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS
U-1001 METHOD FOR DELIVERING DRUG TO LUNG OF MAMMAL, COMPRISING ADMINISTERING DRUG
PRODUCT BY INHALATION. TREATING A MAMMAL HAVING A CONDITION CAPABLE OF TREATMENT
U-1002
BY INHALATION, COMPRISING ADMINISTERING TO THE LUNG THE DRUG PRODUCT BY INHALATION
METHOD OF TREATING INFLAMMATORY CONDITIONS
U-1003 A METHOD OF MYOCARDIAL PERFUSION IMAGING AND INCREASING CORONARY BLOOD FLOW
U-1004 TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
U-1005 METHOD OF TREATING A STAPHYLOCOCCAL INFECTION
U-1006
U-1007
NEW COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD
SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION
HEALING TIME IN ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER)
METHOD OF TREATING GOUT FLARES
U-1008 APPLICATION OF ANTISEPTIC WITH MOISTURIZERS FOR SURGICAL AND HEALTHCARE PERSONNEL
SKIN DISINFECTION
U-1009 METHOD FOR ADMINISTRATION OF TESTOSTERONE
U-1010 TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO
TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH
FOOD TO INCREASE ABSORPTION
U-1011 USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA
AND VOMITING
U-1012 METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG
INTERACTION
U-1013 METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO
TREAT PATIENTS WITH CHRONIC HEPATITIS C
U-1014
U-1015
METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTERFERON ALPHA-2B(PEGYLATED AND
NONPEGYLATED) TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
U-1016 IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1
INFECTION IN TREATMENT-EXPERIENCED ADULT PATIENTS, WHO HAVE EVIDENCE OF VIRAL
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 50 of 62
PATENT USE
REPLICATION AND HIV-1 STRAINS RESISTANT TO AN NNRTI AND OTHER ANTIRETROVIRAL
AGENTS
U-1017 A METHOD OF TREATING NASAL AND NON-NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
U-1018 TREATMENT OF PULMONARY HYPERTENSION BY INHALATION
U-1019 TREATMENT OF PULMONARY HYPERTENSION
U-1020 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
U-1021
U-1022
SHORT-TERM TREATMENT (4-8 WEEKS) OF ACTIVE BENIGN GASTRIC ULCER
FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN
POTENTIALLY CAUSE SKIN INFECTION
U-1023 TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
U-1024 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR
HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY
CONTROLLED IOP
U-1025
U-1026
TREATING FREQUENT HEARTBURN
A METHOD OF TREATING HUMAN SUFFERING FROM OR SUSCEPTIBLE TO PSYCHOSIS.
U-1027
U-1028
REDUCTION OF ELEVATED PLASMA STEROL AND/OR STANOL LEVELS IN A MAMMAL
A METHOD OF DISTRIBUTING SODIUM OXYBATE UNDER CONTROL OF A CENTRAL PHARMACY
U-1029 METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED
THEREOF
U-1030
U-1031
IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)
IMPROVE RESPIRATORY SYMPTOMS IN CYSTIC FIBROSIS IN PATIENTS WITH PSEUDOMONAS
AERUGINOSA
U-1032 USE OF ROSUVASTATIN CALCIUM FOR THE PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE
IN INDIVIDUALS WITHOUT CLINICALLY EVIDENT CORONARY HEART DISEASE BUT WITH
INCREASED RISK FACTORS
U-1033 TOPICAL TREATMENT OF ACNE VULGARIS
U-1034
U-1035
TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN ADULTS
NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE
PAIN
U-1036 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
U-1037 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR IN COMBINATION WITH A PPAR-GAMMA AGONIST
U-1038 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
U-1039 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN
U-1040 INHIBITION OF THROMBIN IN A PATIENT
U-1041 TREATMENT OF DISORDERS RESPONSIVE TO GROWTH HORMONE
U-1042 METHOD FOR STIMULATING CORONARY VASODILATION FOR PURPOSES OF IMAGING THE HEART
U-1043 MANAGEMENT OF MODERATE TO SEVERE PAIN
U-1044 TOPICAL TREATMENT OF SCALP PSORIASIS
U-1045 MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NSCLC WHO
HAVE NOT PROGRESSED ON 1ST-LINE TREATMENT WTH PLATINUM-BASED CHEMOTHERAPY
U-1046 MAINTENANCE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NSCLC WHOSE
DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES PLATINUM-BASED CHEMOTHERAPY
U-1047
U-1048
TREATMENT OF BIOPSY-CONFIRMED, PRIMARY SUPERFICIAL BASAL CELL CARCINOMA (SBCC)
WORKS THROUGH THE INDUCTION OF INTERFERON AND OTHER CYTOKINES
U-1049 PROPHYLAXIS OF ORGAN REJECTION IN ADULT PATIENTS AT LOW-MODERATE IMMUNOLOGIC RISK
RECEIVING A RENAL TRANSPLANT
U-1050 USE OF METAXALONE FOR TREATMENT OF MUSCULSKELETAL CONDITIONS
U-1051 TREATMENT OF OROPHARYNGEAL CANDIDIASIS
U-1052 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED
GASTRIC ULCER
U-1053 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
U-1054 ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON
U-1055
MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2
U-1056
DIABETES MELLITUS WHO ARE ALREADY TREATED WITH A THIAZOLIDINEDIONE (TZD) AND
METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A TZD OR METFORMIN ALONE
TREATMENT OF PAIN USING A NASAL SPRAY OF KETOROLAC TROMETHAMINE
U-1057 TREATMENT OF INFLAMMATION AND PAIN USING A NASAL SPRAY OF KETOROLAC TROMETHAMINE
U-1058 USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS
WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
U-1059 ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA
U-1060 ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 51 of 62
PATENT USE
LEVELS
U-1061 ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA
U-1062 ADMINISTRATION OF APPROVED PRODUCT FOR TREATMENT OF ALZHEIMER'S DISEASE
U-1063
U-1064
TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
U-1065 METHOD OF TREATING ANDROGEN RESPONSIVE OR MEDICATED CONDITION IN A MAMMAL BY
ADMINISTERING A SAFE & EFFECTIVE AMOUNT OF DUTASTERIDE OR A PHARMACEUTICALLY
ACCEPTABLE SOLVATE THEREOF.. CONDITIONS INCLUDE BENIGN PROSTATIC HYPERTROPHY
U-1066 METHOD OF TREATING AN ANDROGEN RESPONSE OR MEDIATED DISEASE IN A MAMMAL BY
ADMININSTERING AN EFFECTIVE ANDROGEN RESPONSIVE OR MEDICATED DISEASE AMOUNT OF
DUTASTERIDE..CONDITIONS INCLUDE BENIGN PROSTATIC HYPERPLASIA
U-1067 TREATMENT OF CANCER
U-1068 TREATMENT OF ASTHMA
U-1069 A METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING AN EXCLUSIVE
COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION
U-1070 A METHOD TO CONTROL ABUSE OF A SENSITIVE DRUG BY CONTROLLING WITH A COMPUTER
PROCESSOR THE DISTRIBUTION OF THE SENSITIVE DRUG VIA AN EXCLUSIVITY CENTRAL
PHARMACY THAT MAINTAINS A CENTRAL DATABASE
U-1071 METHOD OF TREATING BLADDER DSYFUNCTION WITH ONCE A DAY TROSPIUM SALT FORMULATION
U-1072
U-1073
THE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A
CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME
USE FOR THE TREATMENT OF ASTHMA AND COPD
U-1074 USE OF EXENATIDE MAY RESULT IN REDUCTION IN BODY WEIGHT
U-1075 USE FOR THE TREATMENT OF ASTHMA
U-1076 REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA) IN PATIENTS WITH NEUROLOGIC
CONDITIONS ASSOCIATED WITH PROBLEM DROOLING
U-1077 PRETREATMENT OF PATIENTS WITH VITAMIN B12 AND FOLIC ACID PRIOR TO PEMETREXED
DISODIUM ADMINISTRATION
U-1078 TREATMENT OF ACNE
U-1079
U-1080
REVLIMID (LENALIDOMIDE) IS INDICATED FOR THE TREATMENT OF PATIENTS WITH
TRANSFUSION-DEPENDENT ANEMIA IN MYELODYSPLASTIC SYNDROMES (MDS)
METHOD TO TREAT PULMONARY HYPERTENSION BY ADMINISTERING AMBRISENTAN TO A PATIENT
U-1081 LUMIGAN IS A PROSTAGLANDIN ANALOG INDICATED FOR THE REDUCTION OF ELEVATED
INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
U-1082 USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION
WHERE AN INFECTION OR RISK OF INFECTION EXISTS
U-1083 ACUTE TREATMENT OF MIGRAINE ATTACKS, WITH OR WITHOUT AURA, AND THE TREATMENT OF
CLUSTER HEADACHE EPISODES
U-1084 RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID
RESPONSIVE DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER
U-1085 METHOD FOR TREATING IRRITABLE BOWEL SYNDROME AND METHOD FOR TREATING ABDOMINAL
DISCOMFORT ASSOCIATED WITH IRRITABLE BOWEL SYNDROME
U-1086 TREATMENT OF AUTOIMMUNE DISEASE
U-1087 DETECTION OF NON-MUSCLE INVASIVE PAPILLARY CANCER OF THE BLADDER BY PHOTODYNAMIC
CYSTOSCOPY
U-1088 RELIEF OF MUSCLE SPASM
U-1089 INHIBITION OF THROMBIN
U-1090 LO LOESTRIN FE IS INDICATED FOR THE PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO
USE ORAL CONTRACEPTIVES AS A METHOF OF CONTRACEPTION
U-1091 ASSESSMENT OF BRONCHIAL HYPERRESPONSIVENESS IN PATIENTS 6 YEARS OF AGE OR OLDER
WHO DO NOT HAVE CLINICALLY APPARENT ASTHMA
U-1092 TREATMENT OF BREAST CANCER
U-1093 TREATMENT OF PSEUDOBULBAR AFFECT
U-1094 MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN
U-1095 METHOD OF TREATING OCULAR INFLAMMATION
U-1096 TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER
U-1097 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2
DIABETES MELLITUS WHEN TREATMENT WITH BOTH SAXAGLIPTIN AND METFORMIN IS
APPROPRIATE
U-1098
U-1099
U-1100
METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA
TREATMENT OF PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL
NEUROPATHY, POSTHERPETIC NEURALGIA, AND FIBROMYALGIA
REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY
U-1101 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
U-1102 METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY
U-1103 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 52 of 62
PATENT USE
DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
U-1104 USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN
U-1105 TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS FOUR (4) YEARS OF AGE AND
OLDER
U-1106 TREATING HYPERTRIGLYCERIDEMIAS WITH REDUCTION OF FOOD EFFECT
U-1107 TREATING HYPERCHOLESTEROLEMIAS WITH REDUCTION OF FOOD EFFECT
U-1108 TREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE
U-1109 TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL) IN
CONNECTION WITH A SPECIAL PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE
U-1110
EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)
METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN
A COMPUTER SYSTEM FOR DISTRIBUTION
U-1111 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE
PAIN
U-1112 METHOD OF MR IMAGING OF A MAMMAL
U-1113 TREATMENT AND PROPHYLAXIS OF INFLUENZA
U-1114 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING
NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
U-1115 TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD
ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
U-1116 METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
U-1117 TREATMENT OF BREAST CANCER
U-1118 USE FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING
CHRONIC BRONCHITIS AND EMPHYSEMA
U-1119 CONTRAST AGENT FOR MAGNETIC RESONANCE IMAGING
U-1120 TO REDUCE GASTROINTESTINAL SIDE EFFECTS ADMINISTER WITH A MEAL; AS STARTING DOSE
ADMINISTER ONCE DAILY WITH EVENING MEAL
U-1121 METHOD OF TREATING TRAVELERS' DIARRHEA
U-1122 TREATMENT OF SECONDARILY INFECTED TRAUMATIC SKIN LESIONS DUE TO S. AUREUS AND S.
PYOGENES
U-1123 TREATMENT OF ALCOHOL DEPENDENCE
U-1124
U-1125
PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION
METHOD FOR THE DETECTION OF NEUROENDOCRINE TUMORS
U-1126 USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE RECEIVED PRIOR CHEMOTHERAPY
CONTAINING DOCETAXEL
U-1127 TREATMENT OF PATENT DUCTUS ARTERIOSUS
U-1128 TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION IN COMBINATION WITH
PEGINTERFERON ALFA AND RIBAVIRIN IN ADULT PATIENTS (>=18 YEARS OF AGE) WITH
COMPENSATED LIVER DISEASE
U-1129 TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
U-1130
NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE
EVENING OR A NIGHT WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN
U-1131 TREATMENT OF HYPERTRIGLYDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
U-1132
NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT
U-1133 SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE
EVENING OR AT NIGHT
U-1134 TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT
U-1135 TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
U-1136
NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A) AND INCREASE OF HDL-C
SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE
EVENING OR AT NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF
HDL-C
U-1137 TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
U-1138
NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C
TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING
OR AT NIGHT
U-1139 REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER
DAY IN THE EVENING OR AT NIGHT
U-1140 REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT
U-1141 REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
U-1142 TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 53 of 62
PATENT USE
OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN
U-1143 REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER
DAY IN THE EVENING OR A T NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT
SUCH AS ASPIRIN
U-1144 REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
U-1145 REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH
PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN
U-1146 REDUCTION IN TG WITH REDUCED FLUSHING BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT
U-1147 TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING
OR AT NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C
U-1148 REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER
DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTINO OF LDL-C, TC, TG, LP(A), AND
INCREASE OF HDL-C
U-1149 TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN
U-1150 TRETMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, TG, LP(A), AND INCREASE OF HDL-C
U-1151 TREATMENT OF HYPERTRIGLYCDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, LP(A), AND INCREASE OF HDL-C
U-1152 CYANOCOBALAMIN ADMINISTRATION THROUGH NASAL INFUSION
U-1153 IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, IS INDICATED FOR THE TREATMENT OF
HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN ANTIRETROVIRAL TREATMENT-
NAIVE ADULT PATIENTS, AS SET FORTH IN THE LABELING, INCLUDING I&U SECTION
U-1154 TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL
TUMORS, RENAL CELL CARCINOMA AND ADVANCED PANCREATIC NEUROENDOCRINE TUMORS, WITH
SUNITINIB
U-1155 USE OF THALIDOMIDE IN TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM
LEPROSUM (ENL)
U-1156 TO REDUCE BLOOD PHENYLALANINE (PHE) LEVELS IN PATINETS WITH HYPERPHENYLALANINEMIA
(HPA)
U-1157 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES IN ADULTS AND CHILDREN 2
YEARS OF AGE AND OLDER AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH HIVES
(URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER
U-1158 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES AND FOR THE RELIEF OF
SYMPTOMS ASSOCIATED WITH HIVES (URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE
AND OLDER
U-1159 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES, SWELLING OF THE NASAL
PASSAGES AND SINUS CONGESTION AND PRESSURE IN ADULTS AND CHILDREN 12 YEARS OF AGE
AND OLDER
U-1160 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES AND FOR THE RELIEF OF
SYMPTOMS ASSOCIATED WITH HIVES (URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE
AND OLDER AND 12 YEARS OF AGE AND OLDER
U-1161 FOR THE TREATMENT AND PROPHYLAXIS OF GOUT FLARES & THE TREATMENT OF FAMILIAL
MEDITERRANEAN FEVER
U-1162 TREATMENT OF SEBORRHEIC DERMATITIS OF THE SCALP
U-1163 METHOD OF TREATING THROMBOSIS
U-1164 METHOD OF TREATING AN ARGATROBAN TREATABLE CONDITION
U-1165 USE FOR THE TREATMENT OF MULTIPLE MYELOMA
U-1166 A METHOD FOR TREATMENT OF GOUT FLARES DURING PROPHYLAXIS
U-1167 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)
U-1168 THE LONG TERM, ONCE-DAILY MAINTENANCE BROCHODILATOR TREATMENT OF AIRFLOW
OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD),
INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
U-1169 MANAGEMENT OF BREAKTHROUGH PAIN IN CANCER PATIENTS 18 YEARS OF AGE AND OLDER WHO
ARE RECEIVING AND TOLERANT TO OPIOID THERAPY FOR THEIR UNDERLYING PERSISTENT
CANCER PAIN
U-1170 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
U-1171 REDUCTION OF THE RATE OF THROMBOTIC EVENTS IN PATIENTS WITH ACUTE CORONARY
SYNDROME
U-1172 TO REDUCE ELEVATED TOTAL-C, APO B, AND NON-HDL-C IN PATIENTS WIHT PRIMARY
HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE IN COMBINATION WITH A STATIN
U-1173 TO REDUCE ELEVATED TOTAL-C, LDL-C, APO B AND NON-HDL-C IN PATIENTS WITH PRIMARY
HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE ALONE OR IN COMBINATION WITH A
STATIN OR WITH FENOFIBRATE
U-1174 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER
FOR INJECTION, 0.9% SODIUM CHLORIDE INJECTION, OR FLOLAN STERIILE DILUENT FOR
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 54 of 62
PATENT USE
INJECTION PRIOR TO ADMINISTRATION
U-1175 REDUCTION OF CARDIAC TISSUE DAMAGE ASSOCIATED WITH MYOCARDIAL INFARCTION
U-1176 TREATMENT OR PREVENTION OF STROKE
U-1177 REDUCTION OF CARDIAC TISSUE DAMAGE ASSOCIATED WITH MYOCARDIAL INFARCTION
U-1178 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
U-1179
U-1180
TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE
INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING
THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS
U-1181 A METHOD OF TREATING OR PREVENTING OCULAR PAIN IN A PATIENT
U-1182 TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
U-1183 A METHOD FOR ADMINISTERING FOLLICLE STIMULATING HORMONE (FSH) FOR OVARIAN FOLLICLE
OR TESTICULAR STIMULATION IN THE HUMAN
U-1184 TREATMENT OF ERECTILE DYSFUNCTION AND THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC
HYPERPLASIA
U-1185 TREATMENT OF OPIOID-INDUCED CONSTIPATION
U-1186 ADMINISTRATION OF AN INHALABLE POWDER COMPRISING TIOTROPIUM VIA DEVICE
U-1187 TREATMENT OF PATHOLOGICAL STATE BY ANTAGONIZING BRADYKININ RECEPTOR INCLUDING
U-1188
TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE)
METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
U-1189 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
U-1190
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
U-1191
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
METHOD OF TX TYPE 2 DM IN PTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND
U-1192
SIMVASTATIN IS APPROPRIATE, IN COMBO WITH AN AGENT ACTING ON AN ATP-DEPENDENT
CHANNEL IN BETA CELLS SUCH AS A SULFYONYLUREA(INCL GLIPIZIDE, GLIMEPIRIIDE &
GLYBURIDE)
METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
U-1193
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A
SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
METHOD OF TREATING TYPE 2 DIABETES MELITUS IN PATIENTS FOR WHOM TREATMENT WITH
U-1194
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA
AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
METHOD FOR TREATING INSOMNIA
U-1195 PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC
KIDNEY DISEASE (CKD) STAGE 5, WHICH MAY RESULT IN RENAL OSTEODYSTROPHY, WHILE
AVOIDING HYPERPHOSPHATEMIA
U-1196 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO
DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE
TAKING IBUPROFEN FOR THOSE INDICATIONS
U-1197 METHOD OF TREATMENT OF CHILDREN WITH CENTRAL PRECOCIOUS PUBERTY
U-1198 RECTIV IS A NITRATE VASODILATOR INDICATED FOR THE TREATMENT OF MODERATE TO SEVERE
PAIN ASSOCIATED WITH CHRONIC ANAL FISSURE
U-1199 TREATMENT AND PREVENTION OF POSTMENOPAUSAL OR GLUCOCORTICOID-INDUCED OSTEOPOROSIS
AND TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
U-1200 REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
U-1201 FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS
U-1202 METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL
SYNDROME
U-1203 METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
U-1204 TREATMENT OF UVEITIS
U-1205 TREATMENT OF MACULAR EDEMA
U-1206 DELIVERING AN OCULAR IMPLANT AS DESCRIBED IN THE DOSAGE AND ADMINISTRATION SECTION
OF THE APPROVED LABELING OF OZURDEX
U-1207
U-1208
INFANT USE AGED 1 MONTH TO LESS THAN ONE YEAR, GERD AND EROSIVE ESOPHAGITIS
TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR GROWTH INCLUDING
U-1209
LENGTH, THICKNESS AND DARKNESS
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3
YEARS OF AGE AND OLDER
U-1210
U-1211
U-1212
USE OF REVLIMID (LENALIDOMIDE) WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER
CONTRAINDICATED INDIVIDUAL TO REVLIMID (LENALIDOMIDE)
USE OF REVLIMID (LENALIDOMIDE) TO INHIBIT THE SECRETION OF PRO-INFLAMMATORY
CYTOKINES, INCLUDING TUMOR NECROSIS FACTOR ALPHA
USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA AND
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 55 of 62
PATENT USE
U-1213
TRANSFUSION-DEPENDENT ANEMIA IN MYELODYSPLASTIC SYNDROMES (MDS)
TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN IMMUNOCOMPETETENT PATIENTS 12 YEARS
OF AGE AND OLDER
U-1214 METHOD FOR RELIEVING CONSTIPATION IN A HUMAN PATIENT THAT COMPRISES ADMINISTERING
U-1215
U-1216
U-1217
TO THE PATIENT A DOSAGE UNIT COMPRISING (I) 24MCG+/- 10% OF A DRUG SUBSTANCE AND
(II) A PHARMACEUTICALLY SUITABLE EXCIPIENT
USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF TRANSFUSION-DEPENDENT ANEMIA
IN MYELODYSPLASTIC SYNDROMES (MDS)
USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA
METHOD OF INCREASING HAIR GROWTH
U-1218 METHOD OF STIMULATING HAIR GROWTH
U-1219 METHOD OF INCREASING THE NUMBER OF HAIRS
U-1220 TREATMENT OF RENAL CELL CARCINOMA
U-1221 TO STIMULATE THE IMMUNE SYSTEM TO INDUCE T CELL PROLIFERATION
U-1222 TO INHIBIT THE PROLIFERATIVE ACTIVITY OF NEOPLASTIC CELLS
U-1223 METHOD FOR TREATING TYPE 2 DIABETES USING A SUSTAINED-RELEASE COMPOSITION
CONTAINING EXENATIDE
U-1224 REDUCTIONS IN BODY WEIGHT ARE OBSERVED WITH EXENATIDE
U-1225 ACCELERATING THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING
PARTIAL LARGE OR SMALL BOWEL RESECTION SURGERY WITH PRIMARY ANASTOMOSIS
U-1226 A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
U-1227 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
U-1228 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE ALONE OR IN
COMBINATION WITH INSULIN
U-1229 TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
U-1230 A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT
U-1231 TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS
U-1232
U-1233
USE AS ANTICOAGULANT IN PTS W/ UNSTABLE ANGINA UNDERGOING PTCA; W/ PROVISIONAL USE
OF GLYCOPROTEIN IIB/IIIA INHIBITOR, AS ANTICOAGULANT IN PTS UNDERGOING PCI AND FOR
PTS W/, OR AT RISK OF, HIT/HITTS UNDERGOING PCI.INTENTED FOR USE W/ASPIRIN
TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION, ADMINISTERED WITH
FOOD
U-1234
U-1235
FOR REDUCING TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL
TRIGLYCERIDES, AND TREATING HYPERTRIGLYCERIDEMIA
REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR
HYPERTENSION
U-1236
U-1237
USE OF THALOMID (THALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA
COMBO W/ OTHER ANTIRETROVIRALS FOR TX OF HIV-1 IN ANTIRETROVIRAL TX-EXPERIENCED PT
6 YEARS UP, WHO HAVE EVIDENCE OF VIRAL REPLICATION AND HIV-1 STRAINS RESISTANT TO
NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR AND OTHER ANTIRETROVIRALS
U-1238 TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
U-1239 MAGNETIC RESONANCE IMAGING OF THE LIVER
U-1240 TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO
CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION
U-1241 MANAGEMENT OF MODERATE TO SEVERE PAIN BY ORALLY ADMINISTERING AN INTACT
COMPOSITION AS CLAIMED
U-1242
U-1243
PREVENTION OF RESPIRATORY DISTRESS (RDS) IN PREMATURE INFANTS
WITH DRY HANDS, GENTLY REMOVE THE SUPRENZA (PHENTERMINE HYDROCHLORIDE ODT) TABLET
FROM THE BOTTLE. IMMEDIATELY PLACE THE SUPRENZA TABLET ON TOP OF THE TONGUE WHERE
U-1244
IT WILL DISSOLVE, THEN SWALLOW WITH OR WITHOUT WATER
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH SULFONLYUREA
U-1245 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH PIOGLITAZONE
U-1246 SINGLE DOSE ADMINISTRATION INTO THE SURGICAL SITE TO PRODUCE POSTSURGICAL
ANALGESIA
U-1247
U-1248
MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS
USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME
KNEE
U-1249 TREATMENT OF MALE PATIENT HAVING A DISEASE OR CONDITION RESPONSIVE TO A
TERATOGENIC DRUG
U-1250
U-1251
TREATMENT OF PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL
NEUROPATHY OR SPINAL CORD INJURY, POSTHERPETIC NEURALGIA, AND FIBROMYALGIA
A METHOD OF CONTROLLING POSTOPERATIVE OCULAR PAIN AND BURNING/STINGING IN A
PATIENT
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 56 of 62
PATENT USE
U-1252 METHOD FOR CHRONIC WEIGHT MANAGEMENT BY DECREASING FOOD INTAKE
U-1253 METHOD FOR CHRONIC WEIGHT MANAGEMENT BY INDUCING SATIETY
U-1254 METHOD FOR CHRONIC WIEGHT MANAGEMENT BY CONTROLLING WEIGHT GAIN
U-1255 METHOD FOR CHRONIC WEIGHT MANAGEMENT BY TREATING OBESITY
U-1256 TREATMENT OF SEBORRHEIC DERMATITIS
U-1257 TREATMENT OF OPHTHALMIC DISORDERS
U-1258 VISUALIZATION DURING VITRECTOMY PROCEDURES
U-1259 PROPHYLAXIS OF HIV-1 INFECTION
U-1260 TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR
THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED
DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
U-1261 REDUCTION OF THE RISK OF HOSPITALIZATION FOR ATRIAL FIBRILLATION
U-1262
U-1263
U-1264
USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT
NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) OR CHRONIC BRONCHITIS
TREATMENT OF A RESPIRATORY DISEASE
U-1265 PATENTED METHOD OF USING REPAGLINIDE IN COMBINATION WITH METFORMIN AS INDICATED
FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
U-1266 METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA
U-1267 TREATMENT OF RHEUMATOID ARTHRITIS BY DELAYED RELEASE FORMULATION OF 1MG OR 2MG OF
PREDNISONE
U-1268 TREATMENT OF PULMONARY, GASTROINTESTINAL AND/OR RHEUMATOLOGICAL DISEASES OR
CONDITIONS BY USE OF DELAYED RELEASE FORMULATIONS OF 1MG OR 2MG PREDNISONE
U-1269 TREATMENT OF RHEUMATOLOGIC, ALLERGIC, PULMONARY, GASTROINTESTINAL, DERMATOLOGIC
DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 5MG PREDNISONE TABLET
U-1270 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN
U-1271
COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE(PH-) ACUTE
LYMPHOBLASTIC LEUKEMIA (ALL) IN SECOND OR GREATER RELAPSE OR WHOSE DISEASE HAS
PROGRESSED FOLLOWING TWO OR MOR ANTI-LEUKEMIA THERAPIES
U-1272 TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSON'S DISEASE BY APPLICATION OF CLAIMED
TRANSDERMAL SYSTEM
U-1273 TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY
SYSTEM
U-1274 TREATMENT OF EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CYSTIC FIBROSIS OR OTHER
CONDITIONS
U-1275 TREATMENT OF CHRONIC HEPATITIS B IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE
AND OLDER
U-1276 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
U-1277 METHOD OF INCREASING EYELASH GROWTH INCLUDING LENGTH, THICKNESS, DARKNESS AND/OR
NUMBER OF EYELASHES BY ADMINISTERING BIMATOPROST TO AN EYELID MARGIN
U-1278 METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS
U-1279 TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKNIETIC
ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
U-1280 USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
U-1281 THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO
HAVE PREVIOUSLY RECEIVED DOCETAXEL
U-1282 PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING
U-1283 A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
U-1284 A METHOD OF TREATING A NEOPLASM
U-1285 TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
U-1286 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT
WITH INHALED NITRIC OXIDE
U-1287 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
U-1288 TREATEMENT OF ERECTIILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET
U-1289 MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN
U-1290 TREATMENT OF LUNG CANCER
U-1291 TREATMENT OF ACUTE PROMYELOCYTIC LEUKEMIA (APL) IN PATIENTS WHOSE APL IS
CHARACTERIZED BY THE PRESENCE OF THE (15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE
EXPRESSION
U-1292 TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 1, 2, OR 5 MG
PREDNISONE TABLET
U-1293 A METHOD OF LOWERING INTRAOCULAR PRESSURE IN A PATIENT WITH OPEN ANGLE GLAUCOMA OR
OCULAR HYPERTENSION
U-1294 METHOD OF TREATING GLAUCOMA IN A PATIENT
U-1295 A METHOD OF TREATING A PATIENT WITH GLAUCOMA OR OCULAR HYPERTENSION
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 57 of 62
PATENT USE
U-1296 USE OF PEMETREXED WITH PRIOR AND/OR REPEATED VITAMIN B12 AND FOLIC ACID
ADMINISTRATION
U-1297 TREATMENT OF PULMONARY ARTERIAL HYPERTENSION BY INHIBITING ENDOTHELIN RECEPTORS
U-1298 ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES
U-1299
U-1300
U-1301
U-1302
U-1303
TREATMENT OF PATIENTS WITH LEUKEMIA INCLUDING CHRONIC MYELOID/MYELOGENOUS LEUKEMIA
(CML)
TREATMENT OF PATIENTS WITH TYROSINE KINASE INHIBITOR (TKI) RESISTANT OR INTOLERANT
CHRONIC MYELOID/MYELOGENOUS LEUKEMIA (CML)
TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
TREATMENT OF PULMONARY EMBOLISM (PE)
REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY
EMBOLISM
U-1304 USE OF ONCE-A-DAY AMOXICILLIN PRODUCT TO TREAT TONSILLITIS AND/OR PHARYNGITIS
SECONDARY TO STREPTOCOCCUS PYOGENES
U-1305
U-1306
TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN
PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR
(PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE
INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
U-1307 IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1
U-1308
INFECTION IN TREATMENT-NAIVE ADULT PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO
100,000 AT THE START OF THERAPY
MULTIPLE MYELOMA
U-1309 BONE METASTASES
U-1310 FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
U-1311 METHOD OF TREATING CYSTIC FIBROSIS
U-1312 USE FOR THE TREATMENT OF HYPERGLYCEMIA
U-1313 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE
2 DIABETES MELLITUS
U-1314 USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER
U-1315 THE LONG TERM TREATMENT OF PROPHYLACTIC MANAGEMENT OF OCULAR HYPERTENSION AND
GLAUCOMA
U-1316 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN
PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-
WISE INCREASING DOSES
U-1317 TREATMENT OF HYPERCHOLESTEROLEMIA, HYPERLIPIDEMIA AND HYPERLIPOPROTEINEMIA IN
PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
U-1318 TREATMENT OF HYPERCHOLESTEROLEMIA BY DECREASING THE AMOUNT OR ACTIVITY OF
MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN IN PATIENTS WITH HOMOZYGOUS FAMILIAL
HYPERCHOLESTEROLEMIA
U-1319 SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON
PARENTERAL SUPPORT
U-1321 TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS
U-1322 METHOD OF REDUCING OCULAR HYPERTENSION
U-1323 REDUCING THE RISK OF STROKE
U-1324 MANAGEMENT OF CYSTIC FIBROSIS PATIENTS
U-1325 INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE
COLITIS
U-1326 METHOD OF INDUCING CONTRACEPTION IN A FEMALE OF REPRODUCTIVE AGE WHO HAS NOT YET
REACHED PREMENOPAUSE
U-1327 METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING
IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF, USING A
FLOWABLE HYDROGEL FORMULATION
U-1328 METHOF FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING
IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF
U-1329 TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER
U-1330 METHODS OF TREATING LIPID METABOLISM AND GLYCOMETABOLISM DISORDERS COMPRISING
ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION
WITH AN INSULIN SECRETION ENHANCER
U-1331 METHODS OF REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
U-1332 METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 58 of 62
PATENT USE
U-1333 METHODS OF LOWERING ELEVATED POST PRANDIAL BLOOD GLUCOSE LEVELS COMPRISING
ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR
U-1334 METHODS OF TREATING DIABETES COMPRISING ADMINISTERING AN INSULIN SENSITIVITY
ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
U-1335 METHODS OF MODIFYING GLUCOSE METABOLISM AND TREATING DIABETES COMPRISING
ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR AND ONE OR MORE OTHER THERAPEUTIC
AGENTS SUCH AS METFORMIN
U-1336 METHODS OF TREATING DIABETES COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE
INHIBITOR AND METFORMIN
U-1337 METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
U-1338 METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
U-1339 METHODS OF TREATING DIABETES COMPRISING ADMINISTERING AN INSULIN SENSITIVITY
ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
U-1340 METHODS OF TREATING LIPID METABOLISM DISORDERS COMPRISING ADMINISTERING AN INSULIN
SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS
METFORMIN
U-1341 METHODS OF TREATING GLYCOMETABOLISM DISORDERS COMPRISING ADMINISTERING AN INSULIN
SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS
METFORMIN
U-1342 METHODS OF REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
U-1343 METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
U-1344 METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH AN INSULIN PREPARATION
U-1345 USE IN RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH A DOSAGE UNIT
COMPRISING 24MICROG+/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE
EXCIPIENT
U-1346 USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM
GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF
THEOPHYLLINE
U-1347 TREATMENT OF A SKIN DISORDER
U-1348 TREATMENT OF OSTEOARTHRITIS
U-1349 TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS
U-1350 TREATMENT OF ANKYLOSING SPONDYLITIS
U-1351 TREATMENT OF ACUTE PAIN
U-1352 TREATMENT OF PRIMARY DYSMENORRHEA
U-1353 ADJUNCTIVE THERAPY TO LIPID-LOWERING MEDICATIONS AND DIET TO REDUCE LOW DENSITY
LIPOPROTEIN-CHOLESTEROL, APOLIPOPROTEIN B, TOTAL CHOLESTEROL, AND NON-HIGH DENSITY
LIPOPROTEIN CHOLESTEROL IN PTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
U-1354 INHIBITION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN
HYPERSTIMULATION WITH FSH
U-1355 MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND ADOLESCENT
PATIENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHOD FOR TREATING A
RESPIRATORY DISEASE IN A CHILD
U-1356 TREATMENT OF NASAL SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS
AND CHILDREN 6 YEARS OF AGE AND OLDER. TREATMENT OF NASAL SYMPTOMS ASSOCIATED W
PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER
U-1357 TREATMENT OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN
ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHODS FOR
TREATING A RESPIRATORY DISEASE IN A CHILD
U-1358 TREATMENT OF BACTERIAL INFECTIONS IN THE NASAL PASSAGE OF ADULT PATIENTS AND
HEALTH CARE WORKERS WITH METHICILLIN RESISTANT S. AUREUS
U-1359 USE OF POMALIDOMIDE TO INHIBIT THE SECRETION OF PRO-INFLAMMATION CYTOKINES,
INCLUDING TUMOR NECROSIS FACTOR ALPHA
U-1360 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
U-1361 USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER
CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
U-1362 TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG
PREDNISONE TABLET
U-1363 A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING/STINGING FOLLOWING
CORNEAL SURGERY
U-1364
U-1365
MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT
U-1366 TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 59 of 62
PATENT USE
ANOVULATORY INFERTILE WOMEN
U-1367 METHOD OF ADMINISTERING FSH FOR THE TREATMENT OF INFERTILITY THROUGH INDUCTION OF
OVULATION AND PREGNANCY IN ANOVULATORY INFERTILE WOMEN
U-1368 TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC),
AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
U-1369 TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING
OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE
U-1370 TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
U-1371 REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH ELEVATED INTRAOCULAR PRESSURE
OR GLAUCOMA
U-1372 ADMINISTRATION WITHOUT FOOD FOR TREATMENT OF HIV-1 INFECTION
U-1373 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
U-1374
U-1375
TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML)
ADASUVE IS A TYPICAL ANTIPSYCHOTIC INDICATED FOR THE ACUTE TREATMENT OF AGITATION
ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I DISORDER IN ADULTS
U-1376 TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
U-1377 IMPROVE RESPIRATORY SYMPTOMS IN CYSTIC FIBROSIS IN PATIENTS WITH PSEUDOMONAS
AERUGINOSA
U-1378 TREATMENT OF A NITROGEN METAOLISM DISORDER
U-1379 IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE
ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
U-1380 IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE
ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS WHEREIN THE PATIENT HAS
CARDIOVASCULAR DISEASE
U-1381 USE OF PRASUGREL AND ASPIRIN IN PATIENTS REQUIRING THE REDUCTION OF THROMBOTIC
CARDIOVASCULAR EVENTS
U-1382 TREATMETN OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO
CONSERVATIVE MANAGEMENT
U-1383 DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE
DISORDER
U-1384 METHOD OF TREATING MULTIPLE SCLEROSIS
U-1385 METHOD OF TREATING AN AUTOIMMUNE DISEASE SELECTED FROM AUTOIMMUNE POLYARTHRITIS
AND MULTIPLE SCLEROSIS BUT NOT TREATING PSORIATIC ARTHRITIS
U-1386 A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF
U-1387 REDUCTION IN RISK OF HOSPITALIZATION IN PATIENTS WITH A HISTORY OF PAROXYSMAL OR
PERSISTENT AF WITHOUT SEVERE HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY
ADMINISTRATION TWICE A DAILY WITH MORNING AND EVENING MEALS
U-1388 TREATMENT OF PATIENTS WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF WITHOUT SEVERE
HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH
MORNING AND EVENING MEALS
U-1389 ELLA IS AN PROGESTERONE AGONIST/ANTAGONIST EMERGENCY CONTRACEPTION INDICATED FOR
THE PREVENTION OF PREGNANCY FOLLOWING UNPROTECTED INTERCOURSE OR A KNOWN OR
SUSPECTED CONTRACEPTIVE FAILURE. ELLA CAN BE TAKEN WITH OR WITHOUT FOOD
U-1390 A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN
NEED THEREOF
U-1391 METHOD FOR TREATING OPIOID-INDUCED CONSTIPATION
U-1392 METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH OPIOID-
INDUCED CONSTIPATION
U-1393 METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED
CONSTIPATION
U-1394 METHOD FOR RELIEVING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION
U-1395
THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING(I)24MICROG+/-
10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT
USE IN RELIEVING OR PREVENTING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED
CONSTIPATION WITH A DOSAGE UNIT COMPRISING 24MICROG +/- 10% OF A DRUG SUBSTANCE
AND A PHARMACEUTICALLY SUITABLE EXCIPIENT
U-1396 TREATMENT OF ADVANCED HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE BREAST CANCER IN
COMBINATION WITH EXEMESTANE AFTER FAILURE OF TREATMENT WITH LETROZOLE OR
ANASTROZOLE
U-1397 USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY
U-1398 METHOD OF TREATING CHRONIC HEPATITIS C
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO
DIVIDED DOSES
U-1400 FOR THE TREATMENT OF PRIMARY HYPERLIPIDEMIA, MIXED HYPERLIPIDEMIA OR HOMOZYGOUS
FAMILIAL HYPERCHOLESTEROLEMIA
U-1401 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION
IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 60 of 62
PATENT USE
EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
U-1402
U-1403
FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
FIRST-LINE TREATMENT OF METASTATIC NON SMAL-CELL LUNG CANCER (NSCLC) WITH EGFR
EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-
APPROVED TEST
U-1404 METHOD FOR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION BY
OPENING CIC CHANNELS
U-1405 THERAPEUTIC TREATMENT OF BONE METASTASES
U-1406 TREATMENT OF MELANOMA
U-1407 TREATMENT OF NEWLY DIAGNOSED PHILADELPIA CHROMOSOME POSITIVE CHRONIC MYELOID
U-1408
U-1409
LEUKEMIA (PH + CML)
TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER
TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATION
U-1410 TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES
U-1411 THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT
OF OPIOID DEPENDENCE
U-1412 TREATMENT OF ATOPIC DERMATITIS
U-1413 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH FLOLAN STERILE
DILUENT FOR INJECTION PRIOR TO INFUSION
U-1414
U-1415
USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MANTLE CELL LYMPHOMA (MCL)
TREATMING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH
METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS
1 OR 2
U-1416
U-1417
USE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-
LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES
USE FOR TREATMENT OF HELICOBACTER INFECTIONS
U-1418 TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAFV600E
MUTATION AS DETECTED BY AN FDA APPROVED TEST
U-1419 TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
U-1420 METHOD OF ONCE A DAY ADMINISTRATION
U-1421 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE
U-1422 METHOD OF TREATING PATIENTS NEEDING AN IRON SUPPLEMENT
U-1423 AMYVID IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET)
IMAGING OF THE BRAIN TO ESTIMATE BETA-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT
PATIENTS WITH COGNITIVE IMPAIRMENT
U-1424 LONG-TERM, ONCE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH
COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSOTO REDUCE EXACERBATIONS
OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
U-1425 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE
AND NALOXONE
U-1426 USE FOR TREATMENT OF DIAPER DERMATITIS COMPLICATED BY CANDIDIASIS
U-1427 ALKYLATING DRUG INDICATED FOR THE TOPICAL TREATMENT OF STAGE IA AND IB MYCOSIS
FUNGOIDES-TYPE CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO HAVE RECEIVED PRIOR SKIN
DIRECTED THERAPY
U-1428 TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
U-1429 TREATMENT OF PATIENTS WITH BREAST CANCER WHOSE TUMORS OVEREXPRESS THE HER2
RECEPTOR
U-1430
U-1431
TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS
METHOD OF TREATING HYPERGLYCEMIA TO IMPROVE GLYCEMIC CONTROL IN A PATIENT BY ORAL
U-1432
ADMIN OF ONCE A DAY OSMOTIC DOSAGE FORM OF GLIPIZIDE WITH POLYETHYLENE OXIDE,
HYDROXYPROPYLMETHYLCELLULOSE, CELLULOSE ACETATE, AND SODIUM CHLORIDE
METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF
ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX
U-1433 IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE
OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
U-1434 TREATMENT OF PANCREATIC CANCER
U-1435 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AN DADMINISTRATION OF AN ORAL
NSAID.
U-1436 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM
SUNSCREEN AND INSECT REPELLANT
U-1437 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT
FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
U-1438 ZINGO INTRADERMAL INJECTION SYSTEM IS A DRUG DELIVERY SYSTEM THAT IS CAPABLE OF
DELIVERING FINE DRY POWDERED LIDOCAINE HYDROCHLORIDE MONOHYDRATE FOR LOCAL
ANESTHETIC ACTION
U-1439 METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 61 of 62
PATENT USE
U-1440 USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
U-1441
U-1442
A METHOD OF TREATING OR REDUCING OCULAR PAIN AND BURNING/STINGING
SUBCUTANEOUS INJECTION OF METHOTREXATE
U-1443 ACCELERATING THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING
SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS
U-1444
U-1445
A DOSING REGIMEN OF AGGRASTAT (TIROFIBAN HYDROCHLORIDE)(25MCG/KG FOLLOWED BY
0.15MCG/KG/MIN) TO REDUCE THE RATE OF THROMBOTIC CORONARY EVENTS ASSOCIATED WITH
ACUTE CORONARY SYNDROME (ACS) IN PATIENTS WITH NON-ST ELEVATION ACS
METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A
PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHERIN THE
POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION
U-1446 METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING ADMINISTERING MACITENTAN IN
COMBINATION WITH A COMPOUND HAVING PHOSPHODIESTERASE-5 INHIBITORY PROPERTIES
U-1447 TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
U-1448 TREATING SEVERE HYPERTRIGLYCERIDEMIA
U-1449 METHOD OF ALLEVIATING A SKIN CONDITION
U-1450 TREATMENT OF ALLERGIC RHINITIS SYMPTOMS
U-1451 APPROVED INDICATIONS: APTIOM (ESLICARBAZEPINE ACETATE) IS INDICATED AS ADJUNCTIVE
TREATMENT OF PARTIAL-ONSET SEIZURES AND APPROVED IN PATIENTS WITH EPILEPSY.
PATENT CLAIMS: IN A METHOD OF TREATING A SUBJECT AFFLICTED WITH EPILEPSY
U-1452 METHOD FOR CHRONIC WEIGHT MANAGEMENT
U-1453 A METHOD OF TREATING HYPOXIC RESPIRATORY FAILURE BY VERIFYING GAS INFORMATION OF
NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
U-1454 PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
U-1455 TREATMENT OF PERIANAL WARTS
U-1456 TREATMENT OF MANTLE CELL LYMPHOMA
U-1457 A METHOD OF PURGING A NITRIC OXIDE DELIVERY SYSTEM
U-1458 A METHOD OF REDUCING INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR
OCULAR HYPERTENSION
U-1459 TREATMENT OF CARCINOMA OF THE THYROID
U-1460 TREATMENT OF HERPES LABIALIS
U-1461 A METHOD OF GENERATING AN INJECTABLE FOAM OF CONTROLLED DENSITY AND BUBBLE SIZE
U-1462 A METHOD OF USING A SCLEROSING AGENT FOR THE TREATMENT OF INCOMPETENT GREAT
U-1463
SAPHENOUS VEINS, ACCESSORY SAPHENOUS VEINS AND VISIBLE VARICOSITIES OF THE GREAT
SAPHENOUS (GSV) SYSTEM ABOVE AND BELOW THE KNEE
A METHOD OF INTRAVENOUS INJECTION USING ULTRASOUND GUIDANCE, ADMINISTERED VIA A
SINGLE CANNULA INTO THE LUMEN OF THE TARGET INCOMPETENT TRUNK VEINS OR BY DIRECT
INJECTION INTO VARICOSITIES
U-1464
U-1465
TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
USE OF THALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER
CONTRAINDICATED INDIVIDUAL TO THALIDOMIDE
U-1466 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES ADULTS AND CHILDREN 6
YEARS OF AGE AND OLDER
U-1467 METHOD OF TREATING HEPATITIS C
U-1468 CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS
U-1469 USE OF PHOSYLRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
U-1470 FOR THE TREATMENT OF HEPATITIS C
U-1471 A METHOD FOR TREATING CARDIOVASCULAR DISEASE COMPRISING ADMINISTERING A
RECONSTITUTED LYOPHILIZED PHARMACEUTICAL COMPOSITION COMPRISING EPOPROSTENOL,
ARGININE AND SODIUM HYDROXIDE.
U-1472
U-1473
INTENSIVE CARE UNIT SEDATION, INCLUDING SEDATION OF NON-INTUBATED PATIENTS PRIOR
TO AND/OR DURING SURGICAL AND OTHER PROCEDURES
MANAGEMENT OF RISK OF DRONEDARONE/BETA-BLOCKER INTERACTION IN PATIENTS IN SINUS
RYTHM WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF
U-1474 A METHOD FOR THE TREATMENT OF A PATIENT SUFFERING FROM A DISEASE TREATABLE WITH
ROTIGOTINE, COMPRISING APPLYING THE CLAIMED TRANSDERMAL DELIVERY SYSTEM (TDS) TO
THE SKIN OF THE PATIENT
U-1475
U-1476
U-1477
USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO
GROUP 1).
INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW
OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD),
INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION
ON THE SAME KNEE
U-1478 METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE
HYPERTRIGLYCERIDEMIA
U-1479 INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY
34TH EDITION - 2014 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 62 of 62
PATENT USE
EYE).
U-1480 TREATMENT OF ADVANCED RENAL CELL CARCINOMA

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