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Approved Drug Product List - Orange Book

FR Notice Determination of Safety or Effectiveness List


*See List Footnote

March 2016
ACAMPROSATE CALCIUM

TABLET, DELAYED RELEASE;ORAL

CAMPRAL

DISC FOREST LABS
333MG
ACETAMINOPHEN; CODEINE PHOSPHATE

TABLET;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE

DISC KV PHARM
325MG;45MG
DISC ROXANE
500MG;15MG
DISC
500MG;30MG
DISC
500MG;60MG
TYLENOL W/ CODEINE

DISC ORTHO MCNEIL PHARM 325MG;7.5MG


DISC
325MG;15MG
DISC
325MG;30MG
DISC
325MG;60MG

Page 1 of 40

N 021431 001 Apr 04, 2016 Current OB:YES


A
A
A
A

085363
089511
089512
089513

001
001
001
001

Feb
May
May
May

26,
07,
07,
07,

1996 Current
2002 Current
2002 Current
2002 Current

OB:YES

OB:NO

OB:NO

OB:NO

A
A
A
A

085056
085056
085056
085056

001
002
003
004

Nov
Nov
Nov
Nov

25,
25,
25,
25,

2015 Current
2015 Current
2015 Current
2015 Current

OB:YES

OB:YES

OB:YES

OB:YES

ACETAMINOPHEN; HYDROCODONE BITARTRATE



TABLET;ORAL

NORCO

RX
WATSON LABS
325MG;5MG

A 040099 001 Mar 28, 2000 Current OB:NO


ACETAZOLAMIDE

TABLET;ORAL

DIAMOX

DISC TEVA BRANDED PHARM 125MG
DISC
250MG

N 008943 001 Oct 21, 2014 Current OB:YES



N 008943 002 Oct 21, 2014 Current OB:YES

ACETAZOLAMIDE SODIUM

INJECTABLE;INJECTION

DIAMOX

DISC TEVA WOMENS

N 009388 001 Oct 21, 2014 Current OB:YES


EQ 500MG BASE/VIAL

ACETYLCYSTEINE

SOLUTION;INHALATION, ORAL

MUCOMYST

DISC APOTHECON
10%
DISC
20%

N 013601 002 Nov 12, 2013 Current OB:NO



N 013601 001 Nov 12, 2013 Current OB:NO

ACYCLOVIR

TABLET;ORAL

ACYCLOVIR

DISC TEVA

200MG

A 074556 001 May 21, 1996 Current OB:YES


ACYCLOVIR SODIUM

INJECTABLE;INJECTION

ZOVIRAX

DISC GLAXOSMITHKLINE
DISC
DISC

EQ 1GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL

N 018603 002 Apr 11, 2014 Current OB:YES



N 018603 003 Apr 11, 2014 Current OB:YES

N 018603 001 Apr 11, 2014 Current OB:YES

EQ 0.083% BASE
EQ 0.5% BASE

N 019243 002 May 23, 2007 Current OB:NO



N 019243 001 May 23, 2007 Current OB:NO

EQ 0.5% BASE

N 019269 002 Apr 04, 2003 Current OB:NO


EQ 2MG BASE/5ML

N 018062 001 Apr 28, 2008 Current OB:NO


ALBUTEROL SULFATE

SOLUTION;INHALATION

PROVENTIL

DISC SCHERING
DISC
VENTOLIN

DISC GLAXOSMITHKLINE
SYRUP;ORAL

PROVENTIL

DISC SCHERING

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Page 2 of 40

ALCLOMETASONE DIPROPIONATE
CREAM;TOPICAL
ACLOVATE
DISC FOUGERA PHARMS
0.05%
OINTMENT;TOPICAL
ACLOVATE
DISC FOUGERA PHARMS
0.05%

N 018702 001 Jul 20, 2015 Current OB:YES

ALENDRONATE SODIUM
TABLET;ORAL
FOSAMAX
DISC MERCK AND CO INC
DISC
DISC
DISC

N
N
N
N

020560
020560
020560
020560

003
001
004
002

Aug
Aug
Aug
Aug

14,
14,
14,
14,

2014 Current
2014 Current
2014 Current
2014 Current

OB:YES
OB:YES
OB:YES
OB:YES

N
N
N
N

021726
021726
021726
021726

001
002
003
004

Jan
Jan
Jan
Jan

09,
09,
09,
09,

2015 Current
2015 Current
2015 Current
2015 Current

OB:YES
OB:YES
OB:YES
OB:YES

EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
35MG BASE
40MG BASE

ALPRAZOLAM
TABLET, ORALLY DISINTEGRATING;ORAL
NIRAVAM
DISC UCB INC
0.25MG
DISC
0.5MG
DISC
1MG
DISC
2MG
AMANTADINE HYDROCHLORIDE
CAPSULE;ORAL
SYMMETREL
100MG
DISC ENDO PHARMS
TABLET;ORAL
SYMMETREL
DISC ENDO PHARMS
100MG

N 018707 001 Jul 20, 2015 Current OB:YES

N 016020 001 Apr 04, 2016 Current OB:YES

N 018101 001 Mar 02, 2011 Current OB:NO

AMIKACIN SULFATE
INJECTABLE;INJECTION
AMIKIN
DISC APOTHECON
DISC

EQ 50MG BASE/ML
EQ 250MG BASE/ML

N 050495 001 Oct 30, 2015 Current OB:YES


N 050495 002 Oct 30, 2015 Current OB:YES

AMILORIDE HYDROCHLORIDE
TABLET;ORAL
MIDAMOR
RX
PADDOCK LLC

5MG

N 018200 001 Apr 28, 2008 Current OB:NO

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE


TABLET;ORAL
MODURETIC 5-50
DISC MERCK
EQ 5MG ANHYDROUS;50MG

N 018201 001 Apr 28, 2008 Current OB:NO

AMINOCAPROIC ACID
INJECTABLE;INJECTION
AMICAR
DISC CLOVER PHARMS

N 015229 002 May 14, 2009 Current OB:YES

250MG/ML

AMIODARONE HYDROCHLORIDE
INJECTABLE;INJECTION
CORDARONE
DISC WYETH PHARMS INC
50MG/ML
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
TABLET;ORAL
LIMBITROL
DISC HERITAGE PHARMS
EQ 12.5MG BASE;5MG
INC
LIMBITROL DS
DISC HERITAGE PHARMS
EQ 25MG BASE;10MG
INC

N 020377 001 Oct 01, 2008 Current OB:NO

N 016949 001 Sep 27, 2012 Current OB:NO

N 016949 002 Sep 27, 2012 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
AMOXICILLIN; CLAVULANATE
FOR SUSPENSION;ORAL

AUGMENTIN '200'

RX
DR REDDYS LABS INC
AUGMENTIN '400'

RX
DR REDDYS LABS INC
AUGMENTIN ES-600

RX
DR REDDYS LABS INC
TABLET, CHEWABLE;ORAL

AUGMENTIN '125'

RX
DR REDDYS LABS INC
AUGMENTIN '200'

RX
DR REDDYS LABS INC
AUGMENTIN '250'

RX
DR REDDYS LABS INC
AUGMENTIN '400'

RX
DR REDDYS LABS INC

Page 3 of 40

POTASSIUM

200MG/5ML;EQ 28.5MG BASE/5ML

N 050725 001 Dec 07, 2010 Current OB:NO


400MG/5ML;EQ 57MG BASE/5ML

N 050725 002 Dec 07, 2010 Current OB:NO


600MG/5ML;EQ 42.9MG BASE/5ML

N 050755 001 Dec 07, 2010 Current OB:NO


125MG;EQ 31.25MG BASE

N 050597 001 Dec 07, 2010 Current OB:NO


200MG;EQ 28.5MG BASE

N 050726 001 Dec 07, 2010 Current OB:NO


250MG;EQ 62.5MG BASE

N 050597 002 Dec 07, 2010 Current OB:NO


400MG;EQ 57MG BASE

N 050726 002 Dec 07, 2010 Current OB:NO


AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE



CAPSULE;ORAL

DELCOBESE

DISC TEVA
1.25MG;1.25MG;1.25MG;1.25MG
A 083564 001 Nov 10, 2003 Current OB:YES
DISC
2.5MG;2.5MG;2.5MG;2.5MG
A 083564 002 Nov 10, 2003 Current OB:YES
DISC
3.75MG;3.75MG;3.75MG;3.75MG
A 083564 003 Nov 10, 2003 Current OB:YES
DISC
5MG;5MG;5MG;5MG
A 083564 004 Nov 10, 2003 Current OB:YES
TABLET;ORAL
DELCOBESE
DISC TEVA
1.25MG;1.25MG;1.25MG;1.25MG
A 083563 004 Nov 10, 2003 Current OB:NO
DISC
2.5MG;2.5MG;2.5MG;2.5MG
A 083563 003 Nov 10, 2003 Current OB:NO
DISC
3.75MG;3.75MG;3.75MG;3.75MG
A 083563 002 Nov 10, 2003 Current OB:NO
DISC
5MG;5MG;5MG;5MG
A 083563 001 Nov 10, 2003 Current OB:NO
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE;
SULFATE

TABLET;ORAL

ADDERALL 10

DISC TEVA WOMENS
2.5MG;2.5MG;2.5MG;2.5MG
N 011522 007 Nov
ADDERALL 12.5

DISC TEVA WOMENS
3.125MG;3.125MG;3.125MG;3.125MG N 011522 012 Nov
ADDERALL 15

DISC TEVA WOMENS
3.75MG;3.75MG;3.75MG;3.75MG
N 011522 013 Nov
ADDERALL 20

DISC TEVA WOMENS
5MG;5MG;5MG;5MG
N 011522 008 Nov
ADDERALL 30

DISC TEVA WOMENS
7.5MG;7.5MG;7.5MG;7.5MG
N 011522 010 Nov
ADDERALL 5

DISC TEVA WOMENS
1.25MG;1.25MG;1.25MG;1.25MG
N 011522 009 Nov
ADDERALL 7.5

DISC TEVA WOMENS
1.875MG;1.875MG;1.875MG;1.875MG N 011522 011 Nov

DEXTROAMPHETAMINE

12, 2013 Current OB:YES



12, 2013 Current OB:YES

12, 2013 Current OB:YES

12, 2013 Current OB:YES

12, 2013 Current OB:YES

12, 2013 Current OB:YES

12, 2013 Current OB:YES

AMPHETAMINE SULFATE

TABLET;ORAL

AMPHETAMINE SULFATE

DISC LANNETT
5MG
DISC
10MG

A 083901 001 Nov 10, 2010 Current OB:NO



A 083901 002 Nov 10, 2010 Current OB:NO

AMPRENAVIR

SOLUTION;ORAL

AGENERASE

DISC GLAXOSMITHKLINE

N 021039 001 Jul 22, 2011 Current OB:YES


15MG/ML

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
ANAGRELIDE HYDROCHLORIDE

CAPSULE;ORAL

AGRYLIN

DISC SHIRE LLC
EQ 1MG BASE
ARDEPARIN SODIUM

INJECTABLE;INJECTION

NORMIFLO

DISC PHARMACIA AND
UPJOHN

DISC

N 020333 002 Oct 01, 2008 Current OB:NO


5,000 UNITS/0.5ML

N 020227 002 May 23, 2002 Current OB:YES


10,000 UNITS/0.5ML

N 020227 001 May 23, 2002 Current OB:YES


ARIPIPRAZOLE

SOLUTION;ORAL

ABILIFY

DISC OTSUKA
1MG/ML
TABLET, ORALLY DISINTEGRATING;ORAL

ABILIFY

DISC OTSUKA
20MG
DISC
30MG
ARMODAFINIL

TABLET;ORAL

NUVIGIL

DISC CEPHALON
RX

Page 4 of 40

100MG
200MG

N 021713 001 Jun 23, 2015 Current OB:YES


N 021729 004 Dec 03, 2009 Current OB:YES



N 021729 005 Dec 03, 2009 Current OB:YES

N 021875 002 Jul 22, 2011 Current OB:NO



N 021875 005 Jul 22, 2011 Current OB:NO

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE



TABLET;ORAL

NORGESIC

DISC MEDICIS
385MG;30MG;25MG
NORGESIC FORTE

DISC MEDICIS
770MG;60MG;50MG

N 013416 004 Oct 30, 2015 Current OB:YES


ASPIRIN; HYDROCODONE BITARTRATE

TABLET;ORAL

AZDONE

DISC SCHWARZ PHARMA
500MG;5MG

A 089420 001 Oct 05, 2010 Current OB:YES


ATAZANAVIR SULFATE

CAPSULE;ORAL

REYATAZ

DISC BRISTOL MYERS
SQUIBB

ATENOLOL

INJECTABLE;INJECTION

TENORMIN

DISC ASTRAZENECA

EQ 100MG BASE

N 021567 001 Jan 06, 2015 Current OB:YES


0.5MG/ML

N 019058 001 Dec 19, 2008 Current OB:YES


ATORVASTATIN CALCIUM; EZETIMIBE

TABLET;ORAL

LIPTRUZET

DISC MERCK SHARP DOHME
EQ 10MG
DISC
EQ 20MG
DISC
EQ 40MG
DISC
EQ 80MG
ATOVAQUONE

TABLET;ORAL

MEPRON

DISC GLAXOSMITHKLINE
LLC

N 013416 003 Oct 30, 2015 Current OB:YES


250MG

BASE;10MG
BASE;10MG
BASE;10MG
BASE;10MG

N
N
N
N

200153
200153
200153
200153

001
002
003
004

Nov
Nov
Nov
Nov

20,
20,
20,
20,

2015 Current
2015 Current
2015 Current
2015 Current

OB:YES

OB:YES

OB:YES

OB:YES

N 020259 001 May 16, 2007 Current OB:YES


Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
ATRACURIUM BESYLATE

INJECTABLE;INJECTION

TRACRIUM

DISC HOSPIRA
10MG/ML
TRACRIUM PRESERVATIVE FREE

DISC HOSPIRA
10MG/ML

Page 5 of 40

N 018831 002 May 14, 2009 Current OB:YES



N 018831 001 May 14, 2009 Current OB:YES

AZATHIOPRINE

TABLET;ORAL

IMURAN

DISC SEBELA IRELAND LTD 25MG

N 016324 002 Feb 20, 2002 Current OB:NO


AZATHIOPRINE SODIUM

INJECTABLE;INJECTION

IMURAN

DISC SEBELA IRELAND LTD EQ 100MG BASE/VIAL

N 017391 001 May 23, 2007 Current OB:NO


AZITHROMYCIN

CAPSULE;ORAL

ZITHROMAX

DISC PFIZER

N 050670 001 May 20, 2005 Current OB:YES


EQ 250MG BASE

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE



OINTMENT;OPHTHALMIC

CORTISPORIN

DISC CASPER PHARMA LLC
400 UNITS/GM;1%;EQ 3.5MG
N 050416 002 Mar 07, 2008 Current OB:NO

BASE/GM;10,000 UNITS/GM

BACLOFEN

TABLET;ORAL

LIORESAL

DISC NOVARTIS
DISC

10MG
20MG

N 017851 001 Aug 06, 2003 Current OB:NO



N 017851 003 Aug 06, 2003 Current OB:NO

BENZONATATE

CAPSULE;ORAL

TESSALON

DISC PFIZER

200MG

N 011210 003 Jul 20, 2015 Current OB:YES


BENZPHETAMINE HYDROCHLORIDE

TABLET;ORAL

DIDREX

DISC PHARMACIA AND
25MG
UPJOHN

DISC
50MG
BENZTROPINE MESYLATE

TABLET;ORAL

COGENTIN

DISC MERCK
DISC
DISC

N 012427 003 Mar 25, 2010 Current OB:NO



N 012427 002 Dec 04, 2015 Current OB:YES

0.5MG
1MG
2MG

N 009193 004 Aug 06, 2003 Current OB:NO



N 009193 003 Aug 06, 2003 Current OB:NO

N 009193 002 Aug 06, 2003 Current OB:NO

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE



INJECTABLE;INJECTION

CELESTONE SOLUSPAN

RX
MERCK SHARP DOHME
3MG/ML;EQ 3MG BASE/ML

N 014602 001 Jan 12, 2006 Current OB:NO


BETAMETHASONE SODIUM PHOSPHATE



INJECTABLE;INJECTION

CELESTONE

DISC SCHERING
EQ 3MG BASE/ML

N 017561 001 Jan 12, 2006 Current OB:YES


Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
BETHANECHOL CHLORIDE

INJECTABLE;INJECTION

URECHOLINE

DISC ODYSSEY PHARMS
TABLET;ORAL

URECHOLINE

DISC ODYSSEY PHARMS
DISC
DISC
DISC

Page 6 of 40

5MG/ML

N 006536 001 Aug 09, 1999 Current OB:YES


5MG
10MG
25MG
50MG

N
N
N
N

BIMATOPROST

SOLUTION/DROPS;OPHTHALMIC

LUMIGAN

DISC ALLERGAN
0.03%

006536
006536
006536
006536

003
002
004
005

Feb
Feb
Feb
Feb

21,
21,
21,
21,

2001 Current
2001 Current
2001 Current
2001 Current

OB:NO
OB:NO
OB:NO
OB:NO

N 021275 001 Oct 27, 2014 Current OB:YES


BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL

HALFLYTELY

DISC BRAINTREE
5MG,N/A;N/A,210GM;N/A,0.74GM;N/ N 021551 003 Jul 20, 2015 Current OB:YES

A,2.86GM;N/A,5.6GM

BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

TABLET, CHEWABLE, TABLET, CAPSULE;ORAL

HELIDAC

DISC SEBELA IRELAND LTD 262.4MG,N/A,N/A;N/A,250MG,N/A;N N 050719 001 Jul 20, 2015 Current OB:YES

/A,N/A,500MG

BRIMONIDINE TARTRATE

SOLUTION/DROPS;OPHTHALMIC

ALPHAGAN

DISC ALLERGAN
0.2%
BROMFENAC SODIUM

SOLUTION/DROPS;OPHTHALMIC

BROMDAY

DISC BAUSCH AND LOMB
EQ 0.09% ACID
INC

XIBROM

DISC BAUSCH AND LOMB
EQ 0.09% ACID
INC

BUMETANIDE

INJECTABLE;INJECTION

BUMEX

DISC VALIDUS PHARMS INC
TABLET;ORAL

BUMEX

RX
VALIDUS PHARMS INC
RX
RX

N 020613 001 Jun 11, 2003 Current OB:NO


N 021664 002 Dec 04, 2015 Current OB:YES


N 021664 001 May 13, 2011 Current OB:NO


0.25MG/ML

N 018226 001 Sep 06, 2007 Current OB:NO


0.5MG
1MG
2MG

N 018225 002 Oct 30, 2015 Current OB:YES



N 018225 001 Oct 30, 2015 Current OB:YES

N 018225 003 Oct 30, 2015 Current OB:YES

BUPRENORPHINE HYDROCHLORIDE

TABLET;SUBLINGUAL

SUBUTEX

DISC INDIVIOR INC
EQ 2MG BASE
DISC
EQ 8MG BASE

N 020732 002 Feb 13, 2015 Current OB:YES



N 020732 003 Feb 13, 2015 Current OB:YES

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE



TABLET;SUBLINGUAL

SUBOXONE

DISC INDIVIOR INC
EQ 2MG BASE;EQ 0.5MG BASE
DISC
EQ 8MG BASE;EQ 2MG BASE

N 020733 001 Jun 06, 2013 Current OB:NO



N 020733 002 Jun 06, 2013 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
BUSPIRONE HYDROCHLORIDE
TABLET;ORAL
BUSPAR
DISC BRISTOL MYERS
SQUIBB
DISC
DISC
CABERGOLINE
TABLET;ORAL
DOSTINEX
DISC PHARMACIA AND
UPJOHN

10MG

N 018731 002 Oct 19, 2010 Current OB:NO

15MG
30MG

N 018731 003 Oct 19, 2010 Current OB:NO


N 018731 004 Oct 19, 2010 Current OB:NO

0.5MG

N 020664 001 Mar 11, 2010 Current OB:NO

CAFFEINE; ERGOTAMINE TARTRATE


SUPPOSITORY;RECTAL
CAFERGOT
DISC NOVARTIS
100MG;2MG
CALCIPOTRIENE
OINTMENT;TOPICAL
DOVONEX
DISC LEO PHARMA AS
SOLUTION;TOPICAL
DOVONEX
DISC LEO PHARM
CALCIUM ACETATE
TABLET;ORAL
PHOSLO
DISC FRESENIUS MEDCL

Page 7 of 40

N 009000 002 Apr 28, 2008 Current OB:NO

0.005%

N 020273 001 Mar 09, 2010 Current OB:NO

0.005%

N 020611 001 Oct 27, 2014 Current OB:YES

EQ 169MG CALCIUM

N 019976 001 Aug 06, 2007 Current OB:NO

CALCIUM CARBONATE; RISEDRONATE SODIUM


TABLET, TABLET;ORAL
ACTONEL WITH CALCIUM (COPACKAGED)
DISC WARNER CHILCOTT
EQ 500MG BASE,N/A;N/A,35MG

N 021823 001 Jul 07, 2010 Current OB:YES

CAPTOPRIL
TABLET;ORAL
CAPOTEN
DISC PAR PHARM
DISC
DISC
DISC
DISC
DISC
DISC

N
N
N
N
N
N
N

12.5MG
25MG
37.5MG
50MG
75MG
100MG
150MG

CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
CAPOZIDE 25/15
DISC APOTHECON
25MG;15MG
CAPOZIDE 25/25
DISC APOTHECON
25MG;25MG
CAPOZIDE 50/15
DISC APOTHECON
50MG;15MG
CAPOZIDE 50/25
DISC APOTHECON
50MG;25MG
CARBIDOPA; LEVODOPA
TABLET, ORALLY DISINTEGRATING;ORAL
PARCOPA
10MG;100MG
DISC UCB INC
25MG;100MG
DISC
25MG;250MG
DISC

018343
018343
018343
018343
018343
018343
018343

005
002
006
001
007
003
004

Oct
Oct
Jan
Oct
Jan
Oct
Jan

30,
30,
21,
30,
21,
30,
21,

2015 Current
2015 Current
2016 Current
2015 Current
2016 Current
2015 Current
2016 Current

OB:YES
OB:YES
OB:YES
OB:YES
OB:YES
OB:YES
OB:YES

N 018709 001 Jan 09, 2015 Current OB:YES


N 018709 002 Jan 09, 2015 Current OB:YES
N 018709 004 Jan 09, 2015 Current OB:YES
N 018709 003 Jan 09, 2015 Current OB:YES

A 076699 001 Jan 09, 2015 Current OB:YES


A 076699 002 Jan 09, 2015 Current OB:YES
A 076699 003 Jan 09, 2015 Current OB:YES

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
CARBINOXAMINE MALEATE

ELIXIR;ORAL

CLISTIN

DISC MCNEIL

4MG/5ML

CARBOPLATIN

INJECTABLE;INJECTION

PARAPLATIN

DISC CORDEN PHARMA
50MG/VIAL
DISC
150MG/VIAL
INJECTABLE;IV (INFUSION)

PARAPLATIN

DISC CORDENPHARMA
50MG/5ML (10MG/ML)
DISC
150MG/15ML (10MG/ML)
DISC
450MG/45ML (10MG/ML)
DISC
600MG/60ML (10MG/ML)
CEFADROXIL/CEFADROXIL HEMIHYDRATE

CAPSULE;ORAL

DURICEF

DISC WARNER CHILCOTT
EQ 500MG BASE
FOR SUSPENSION;ORAL

DURICEF

DISC WARNER CHILCOTT
EQ 125MG BASE/5ML
DISC
EQ 250MG BASE/5ML
DISC
EQ 500MG BASE/5ML
TABLET;ORAL

DURICEF

DISC WARNER CHILCOTT
EQ 1GM BASE
CEFAZOLIN SODIUM

INJECTABLE;INJECTION

ANCEF

DISC GLAXOSMITHKLINE
DISC
DISC
DISC
CEFAZOLIN SODIUM

DISC FRESENIUS KABI USA
DISC
CEFIXIME

FOR SUSPENSION;ORAL

SUPRAX

DISC LEDERLE
TABLET;ORAL

SUPRAX

DISC LEDERLE
DISC

EQ
EQ
EQ
EQ

1GM BASE/VIAL
5GM BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL

N 008955 001 Apr 10, 2000 Current OB:YES


N 019880 001 Dec 19, 2008 Current OB:NO



N 019880 002 Dec 19, 2008 Current OB:NO

N
N
N
N

020452
020452
020452
020452

001
002
003
004

Jun
Jun
Jun
Jun

15,
15,
15,
15,

2012 Current
2012 Current
2012 Current
2012 Current

OB:NO

OB:NO

OB:NO

OB:NO

N 050512 001 Mar 26, 2007 Current OB:NO


N 050527 002 Mar 02, 2011 Current OB:NO



N 050527 003 Mar 02, 2011 Current OB:NO

N 050527 001 Mar 02, 2011 Current OB:NO

N 050528 001 Mar 26, 2007 Current OB:NO


N
N
N
N

050461
050461
050461
050461

003
004
001
002

Oct
Mar
Mar
Mar

30,
07,
07,
07,

2015 Current
2008 Current
2008 Current
2008 Current

OB:YES

OB:YES

OB:YES

OB:NO

EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL

A 064169 002 Oct 30, 2015 Current OB:YES



A 064169 001 Oct 30, 2015 Current OB:YES

100MG/5ML

N 050622 001 Feb 18, 2004 Current OB:YES


200MG
400MG

N 050621 001 Feb 18, 2004 Current OB:YES



N 050621 002 Feb 18, 2004 Current OB:YES

CEFMETAZOLE SODIUM

INJECTABLE;INJECTION

ZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND
EQ 20MG BASE/ML
UPJOHN

DISC
EQ 40MG BASE/ML
CEFOTETAN DISODIUM

INJECTABLE;INJECTION

CEFOTAN

RX
TELIGENT PHARMA
INC

RX
DISC

Page 8 of 40

N 050683 001 Mar 10, 2014 Current OB:YES



N 050683 002 Mar 10, 2014 Current OB:YES

EQ 1GM BASE/VIAL

N 050588 001 Jun 07, 2007 Current OB:NO


EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL

N 050588 002 Jun 07, 2007 Current OB:NO



N 050588 003 Jun 07, 2007 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
CEFOXITIN SODIUM
INJECTABLE;INJECTION
MEFOXIN
DISC MYLAN
INSTITUTIONAL
DISC
DISC
CEFPODOXIME PROXETIL
FOR SUSPENSION;ORAL
VANTIN
DISC PHARMACIA AND
UPJOHN
DISC

EQ 1GM BASE/VIAL

N 050517 001 Sep 06, 2007 Current OB:NO

EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL

N 050517 002 Sep 06, 2007 Current OB:NO


N 050517 003 Sep 06, 2007 Current OB:NO

EQ 50MG BASE/5ML

N 050675 001 Jan 21, 2016 Current OB:YES

EQ 100MG BASE/5ML

N 050675 002 Jan 21, 2016 Current OB:YES

CEFTRIAXONE SODIUM
INJECTABLE;INJECTION
ROCEPHIN
DISC HOFFMANN LA ROCHE
EQ
INJECTABLE;INTRAMUSCULAR,
ROCEPHIN
EQ
DISC HOFFMANN LA ROCHE
EQ
DISC
EQ
DISC
EQ
DISC
CEPHALEXIN
CAPSULE;ORAL
KEFLEX
DISC SHIONOGI INC
FOR SUSPENSION;ORAL
CEPHALEXIN
DISC FACTA FARMA
DISC
DISC
KEFLEX
DISC PRAGMA PHARMS LLC
DISC
DISC
CHENODIOL
TABLET;ORAL
CHENIX
DISC SIGMA TAU
CHLOROTHIAZIDE
SUSPENSION;ORAL
DIURIL
RX
SALIX PHARMS
TABLET;ORAL
DIURIL
DISC OAK PHARMS AKORN
DISC
CHLORPROMAZINE
SUPPOSITORY;RECTAL
THORAZINE
DISC GLAXOSMITHKLINE
DISC

Page 9 of 40

10GM BASE/VIAL
INTRAVENOUS

N 050585 005 Mar 15, 2011 Current OB:NO

1GM BASE/VIAL
2GM BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL

N
N
N
N

050585
050585
050585
050585

003
004
001
002

Mar
Mar
Mar
Mar

15,
15,
15,
15,

2011 Current
2011 Current
2011 Current
2011 Current

OB:NO
OB:NO
OB:NO
OB:NO

EQ 333MG BASE

N 050405 004 Apr 12, 2011 Current OB:NO

EQ 100MG BASE/ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML

A 062117 001 Mar 15, 2016 Current OB:YES


A 062117 002 Mar 15, 2016 Current OB:YES
A 062117 003 Mar 15, 2016 Current OB:YES

EQ 100MG BASE/ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML

N 050406 003 Mar 15, 2016 Current OB:YES


N 050406 001 Mar 15, 2016 Current OB:YES
N 050406 002 Mar 15, 2016 Current OB:YES

250MG

N 018513 002 May 23, 2007 Current OB:NO

250MG/5ML

N 011870 001 May 23, 2007 Current OB:NO

250MG
500MG

N 011145 004 May 23, 2007 Current OB:NO


N 011145 002 May 23, 2007 Current OB:NO

25MG
100MG

N 009149 024 Jun 15, 2009 Current OB:YES


N 009149 033 Jun 15, 2009 Current OB:YES

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
CHLORPROMAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
THORAZINE
30MG/ML
DISC GLAXOSMITHKLINE
100MG/ML
DISC
INJECTABLE;INJECTION
THORAZINE
DISC GLAXOSMITHKLINE
25MG/ML
SYRUP;ORAL
THORAZINE
DISC GLAXOSMITHKLINE
10MG/5ML
TABLET;ORAL
CHLORPROMAZINE HYDROCHLORIDE
10MG
DISC SANDOZ
25MG
DISC
50MG
DISC
100MG
DISC
200MG
DISC
THORAZINE
10MG
DISC GLAXOSMITHKLINE
25MG
DISC
50MG
DISC
100MG
DISC
200MG
DISC
CHLORTHALIDONE
TABLET;ORAL
HYGROTON
DISC SANOFI AVENTIS US
DISC

25MG
50MG

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE


TABLET;ORAL
COMBIPRES
DISC BOEHRINGER
15MG;0.1MG
INGELHEIM
DISC
15MG;0.2MG
DISC
15MG;0.3MG

Page 10 of 40

N 009149 032 Jun 15, 2009 Current OB:YES


N 009149 043 Jun 15, 2009 Current OB:YES

N 009149 011 Jun 15, 2009 Current OB:NO

N 009149 022 Jun 15, 2009 Current OB:YES

A
A
A
A
A

080439
080439
080439
080439
080439

001
002
003
004
005

Jan
Jan
Jan
Jan
Jan

21,
21,
21,
21,
21,

2016 Current
2016 Current
2016 Current
2016 Current
2016 Current

OB:YES
OB:YES
OB:YES
OB:YES
OB:YES

N
N
N
N
N

009149
009149
009149
009149
009149

002
007
013
018
020

May
May
May
May
May

23,
23,
23,
23,
23,

2007 Current
2007 Current
2007 Current
2007 Current
2007 Current

OB:YES
OB:YES
OB:YES
OB:YES
OB:YES

N 012283 004 Feb 18, 2004 Current OB:YES


N 012283 003 Feb 18, 2004 Current OB:YES

N 017503 001 Feb 18, 2004 Current OB:YES


N 017503 002 Feb 18, 2004 Current OB:YES
N 017503 003 Feb 18, 2004 Current OB:YES

CHLORZOXAZONE
TABLET;ORAL
PARAFLEX
DISC ORTHO MCNEIL PHARM 250MG

N 011300 003 Oct 23, 2013 Current OB:YES

CHYMOPAPAIN
INJECTABLE;INJECTION
CHYMODIACTIN
DISC CHART MEDCL

10,000 UNITS/VIAL

N 018663 001 Jan 27, 2003 Current OB:YES

EQ 75MG BASE/ML

N 020638 001 Oct 30, 2015 Current OB:YES

200MG
300MG
400MG
800MG

N
N
N
N

CIDOFOVIR
INJECTABLE;INJECTION
VISTIDE
DISC GILEAD SCIENCES
INC
CIMETIDINE
TABLET;ORAL
TAGAMET
DISC GLAXOSMITHKLINE
DISC
DISC
DISC

017920
017920
017920
017920

002
003
004
005

Jan
Jan
Jan
Jan

09,
09,
09,
09,

2015 Current
2015 Current
2015 Current
2015 Current

OB:YES
OB:YES
OB:YES
OB:YES

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Page 11 of 40

CIMETIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

TAGAMET

DISC GLAXOSMITHKLINE
EQ 300MG BASE/2ML
N 017939 002 May 23, 2007 Current OB:NO

TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE
EQ 6MG BASE/ML
N 019434 001 May 23, 2007 Current OB:NO

SOLUTION;ORAL

TAGAMET

DISC GLAXOSMITHKLINE
EQ 300MG BASE/5ML
N 017924 001 Mar 11, 2010 Current OB:NO

CITALOPRAM HYDROBROMIDE

SOLUTION;ORAL

CELEXA

DISC FOREST LABS
EQ 10MG BASE/5ML

N 021046 001 Aug 14, 2014 Current OB:YES


CLADRIBINE

INJECTABLE;INJECTION

LEUSTATIN

DISC JANSSEN PHARMS

N 020229 001 Aug 14, 2014 Current OB:YES


1MG/ML

CLARITHROMYCIN

TABLET, EXTENDED RELEASE;ORAL

BIAXIN XL

DISC ABBVIE
500MG

N 050775 001 Aug 27, 2015 Current OB:YES


CLEMASTINE FUMARATE

SYRUP;ORAL

TAVIST

DISC NOVARTIS

N 018675 001 May 23, 2007 Current OB:NO


EQ 0.5MG BASE/5ML

CLINDAMYCIN PALMITATE HYDROCHLORIDE



FOR SOLUTION;ORAL

CLEOCIN

DISC PHARMACIA AND
EQ 75MG BASE/5ML
UPJOHN

CLOBETASOL PROPIONATE

CREAM;TOPICAL

TEMOVATE

DISC FOUGERA PHARMS
TEMOVATE E

DISC FOUGERA PHARMS
GEL;TOPICAL

TEMOVATE

DISC FOUGERA PHARMS
SOLUTION;TOPICAL

TEMOVATE

DISC FOUGERA PHARMS

A 061827 001 Jan 21, 2016 Current OB:YES


0.05%

N 019322 001 Oct 30, 2015 Current OB:YES


0.05%

N 020340 001 Oct 30, 2015 Current OB:YES


0.05%

N 020337 001 Oct 30, 2015 Current OB:YES


0.05%

N 019966 001 Jan 26, 2015 Current OB:YES


CLONAZEPAM

TABLET, ORALLY DISINTEGRATING;ORAL

KLONOPIN RAPIDLY DISINTEGRATING



DISC ROCHE
0.125MG
DISC
0.25MG
DISC
0.5MG
DISC
1MG
DISC
2MG
CLONIDINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

JENLOGA

DISC CONCORDIA PHARMS
0.1MG
INC

DISC
0.2MG
KAPVAY

DISC CONCORDIA PHARMS
0.2MG

N
N
N
N
N

020813
020813
020813
020813
020813

001
002
003
004
005

Aug
Aug
Aug
Aug
Aug

14,
14,
14,
14,
14,

2014 Current
2014 Current
2014 Current
2014 Current
2014 Current

OB:YES

OB:YES

OB:YES

OB:YES

OB:YES

N 022331 001 Feb 13, 2012 Current OB:NO



N 022331 002 Feb 13, 2012 Current OB:NO

N 022331 004 Feb 13, 2012 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Page 12 of 40

TABLET, EXTENDED RELEASE;ORAL


KAPVAY
INC
CLOTRIMAZOLE
SOLUTION;TOPICAL
MYCELEX
DISC BAYER HLTHCARE
TROCHE/LOZENGE;ORAL
MYCELEX
DISC BAYER HLTHCARE

1%

N 018181 001 Aug 19, 2013 Current OB:NO

10MG

N 018713 001 Aug 19, 2013 Current OB:NO

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE



SYRUP;ORAL

PHENERGAN VC W/ CODEINE

DISC ANI PHARMS


10MG/5ML;5MG/5ML;6.25MG/5ML
N 008306 005 Apr 28, 2008 Current OB:NO

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHENERGAN W/ CODEINE

DISC ANI PHARMS


10MG/5ML;6.25MG/5ML

N 008306 004 Apr 28, 2008 Current OB:NO


COLCHICINE; PROBENECID

TABLET;ORAL

COLBENEMID

DISC MERCK

N 012383 001 Aug 06, 2003 Current OB:NO


0.5MG;500MG

CROMOLYN SODIUM

CAPSULE;INHALATION

INTAL

DISC SANOFI AVENTIS US
20MG
SOLUTION/DROPS;OPHTHALMIC

OPTICROM

DISC ALLERGAN
4%
CYANOCOBALAMIN

INJECTABLE;INJECTION

RUBRAMIN PC

DISC BRISTOL MYERS
SQUIBB

DISC

N 016990 001 Oct 23, 2013 Current OB:YES


N 018155 001 Mar 09, 2015 Current OB:YES


1MG/ML

N 006799 004 Dec 19, 2008 Current OB:NO


1MG/ML

N 006799 010 Dec 19, 2008 Current OB:NO


CYCLOPHOSPHAMIDE

TABLET;ORAL

CYTOXAN

DISC BAXTER HLTHCARE
DISC

25MG
50MG

N 012141 002 Mar 11, 2010 Current OB:NO



N 012141 001 Mar 11, 2010 Current OB:NO

CYCLOSPORINE

CAPSULE;ORAL

NEORAL

DISC NOVARTIS

50MG

N 050715 003 Jun 20, 2001 Current OB:NO


CYPROHEPTADINE HYDROCHLORIDE

TABLET;ORAL

PERIACTIN

DISC MERCK
4MG

N 012649 001 May 28, 2003 Current OB:NO


CYSTEINE HYDROCHLORIDE

INJECTABLE;INJECTION

CYSTEINE HYDROCHLORIDE

DISC HOSPIRA
7.25%

N 019523 001 Jun 04, 2010 Current OB:YES


Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Page 13 of 40

CYTARABINE

INJECTABLE;INJECTION

CYTARABINE

DISC TEVA PARENTERAL
DISC
DISC
DISC

1GM/VIAL
2GM/VIAL
100MG/VIAL
500MG/VIAL

N
N
N
N

DARUNAVIR ETHANOLATE

TABLET;ORAL

PREZISTA

DISC JANSSEN PRODS
DISC

EQ 300MG BASE
EQ 400MG BASE

N 021976 001 Jan 18, 2012 Current OB:YES



N 021976 003 Apr 02, 2014 Current OB:YES

016793
016793
016793
016793

003
004
001
002

Jan
Jan
Jan
Jan

21,
21,
21,
21,

2016 Current
2016 Current
2016 Current
2016 Current

OB:YES

OB:YES

OB:YES

OB:YES

DESOGESTREL; ETHINYL ESTRADIOL

TABLET;ORAL-28

MIRCETTE

DISC TEVA BRANDED PHARM 0.15MG,N/A;0.02MG,0.01MG;0.02MG N 020713 001 Jan 09, 2015 Current OB:YES

,0.01MG

DESOXIMETASONE

CREAM;TOPICAL

TOPICORT

DISC TARO PHARMS NORTH
TOPICORT LP

DISC TARO PHARMS NORTH
OINTMENT;TOPICAL

TOPICORT

DISC TARO PHARMS NORTH
DEXAMETHASONE

AEROSOL;TOPICAL

AEROSEB-DEX

DISC ALLERGAN HERBERT
DECASPRAY

DISC MERCK
TABLET;ORAL

DECADRON

DISC MERCK
DISC
DISC
DISC
DISC
DISC
DEXAMETHASONE ACETATE

INJECTABLE;INJECTION

DECADRON-LA

DISC MERCK

0.25%

N 017856 001 Oct 27, 2014 Current OB:YES


0.05%

N 018309 001 Apr 04, 2016 Current OB:YES


0.25%

N 018763 001 Sep 07, 2012 Current OB:NO


0.01%

A 083296 002 Feb 09, 2011 Current OB:YES


0.04%

N 012731 002 Feb 09, 2011 Current OB:YES


0.25MG
0.5MG
0.75MG
1.5MG
4MG
6MG

N
N
N
N
N
N

EQ 8MG BASE/ML

N 016675 001 Aug 24, 2004 Current OB:YES


011664
011664
011664
011664
011664
011664

004
001
002
003
005
006

May
May
May
Dec
May
May

23,
14,
14,
28,
23,
23,

2007 Current
2009 Current
2009 Current
2005 Current
2007 Current
2007 Current

OB:YES

OB:YES

OB:YES

OB:NO

OB:NO

OB:NO

DEXAMETHASONE SODIUM PHOSPHATE



INJECTABLE;INJECTION

DECADRON

DISC MERCK
EQ 4MG PHOSPHATE/ML
DISC
EQ 24MG PHOSPHATE/ML
HEXADROL

DISC ORGANON USA INC
EQ 4MG PHOSPHATE/ML
DISC
EQ 10MG PHOSPHATE/ML

N 014694 002 Oct 10, 2003 Current OB:NO



N 014694 003 Oct 10, 2003 Current OB:NO

DEXTROAMPHETAMINE SULFATE

ELIXIR;ORAL

DEXEDRINE

DISC GLAXOSMITHKLINE
5MG/5ML

A 083902 001 Aug 07, 2007 Current OB:YES


N 012071 002 Oct 10, 2003 Current OB:NO



N 012071 004 Oct 10, 2003 Current OB:YES

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
TABLET;ORAL

DEXEDRINE

DISC GLAXOSMITHKLINE
5MG
DEXTROAMPHETAMINE SULFATE

DISC LANNETT
15MG
DEXTROSTAT

DISC SHIRE
5MG
DISC
10MG

Page 14 of 40

A 084935 001 Mar 02, 2011 Current OB:NO



A 085652 001 Oct 18, 2002 Current OB:NO

A 084051 001 Mar 02, 2011 Current OB:NO

A 084051 002 Mar 02, 2011 Current OB:NO

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE



SYRUP;ORAL

PROMETH W/ DEXTROMETHORPHAN

RX
G AND W LABS INC
15MG/5ML;6.25MG/5ML
A 088762 001 Jul 20, 2015 Current OB:YES

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS
15MG/5ML;6.25MG/5ML
N 011265 002 Apr 28, 2008 Current OB:NO

DIAZEPAM

GEL;RECTAL

DIASTAT

DISC VALEANT PHARMS
NORTH

DISC
DISC
DISC
INJECTABLE;INJECTION

DIAZEPAM

DISC US ARMY

5MG/ML (5MG/ML)

N 020648 002 Aug 18, 2010 Current OB:YES


10MG/2ML (5MG/ML)
15MG/3ML (5MG/ML)
20MG/4ML (5MG/ML)

N 020648 003 Aug 18, 2010 Current OB:NO



N 020648 004 Aug 18, 2010 Current OB:NO

N 020648 005 Aug 18, 2010 Current OB:NO

5MG/ML

N 020124 001 Dec 30, 2002 Current OB:NO


DICHLORPHENAMIDE

TABLET;ORAL

DARANIDE

DISC TARO

50MG

N 011366 001 Aug 06, 2007 Current OB:YES


DICLOFENAC POTASSIUM

TABLET;ORAL

CATAFLAM

DISC NOVARTIS

25MG

N 020142 001 Nov 18, 2003 Current OB:YES


DICLOFENAC SODIUM

TABLET, DELAYED RELEASE;ORAL

VOLTAREN

DISC NOVARTIS
25MG
DISC
50MG
DISC
75MG

N 019201 001 May 23, 2007 Current OB:NO



N 019201 002 May 23, 2007 Current OB:NO

N 019201 003 Jul 22, 2011 Current OB:NO

DIFLUNISAL

TABLET;ORAL

DOLOBID

DISC MERCK
DISC

N 018445 001 Jun 15, 2009 Current OB:YES



N 018445 002 Jun 15, 2009 Current OB:NO

250MG
500MG

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

CARDIZEM SR

DISC BIOVAIL
60MG
DISC
90MG
DISC
120MG
DISC
180MG
DILACOR XR

DISC ACTAVIS LABS UT
120MG
INC

DISC
180MG
DISC
240MG

N
N
N
N

019471
019471
019471
019471

001
002
003
004

May
May
May
May

23,
23,
23,
23,

2007 Current
2007 Current
2007 Current
2007 Current

OB:NO

OB:NO

OB:NO

OB:NO

N 020092 001 Jul 20, 2015 Current OB:YES



N 020092 002 Jul 20, 2015 Current OB:YES

N 020092 003 Jul 20, 2015 Current OB:YES

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
INJECTABLE;INJECTION

CARDIZEM

DISC BIOVAIL LABS INTL
DISC

Page 15 of 40

5MG/ML
25MG/VIAL

N 020027 001 Jun 15, 2009 Current OB:NO



N 020027 003 Jun 15, 2009 Current OB:YES

5MG/ML

N 019817 001 May 23, 2007 Current OB:NO


DISULFIRAM

TABLET;ORAL

ANTABUSE

DISC TEVA WOMENS
DISC

250MG
500MG

N 007883 003 Sep 26, 2001 Current OB:NO



N 007883 002 Jul 13, 2001 Current OB:NO

DOCETAXEL

INJECTABLE;INJECTION

TAXOTERE

DISC SANOFI AVENTIS US

40MG/ML

N 020449 001 Nov 28, 2011 Current OB:YES


EQ
EQ
EQ
EQ
EQ
EQ

N
N
N
N
N
N

DIPYRIDAMOLE

INJECTABLE;INJECTION

IV PERSANTINE

DISC BOEHRINGER
INGELHEIM

DOXEPIN HYDROCHLORIDE

CAPSULE;ORAL

SINEQUAN

DISC PFIZER
DISC
DISC
DISC
DISC
DISC
CONCENTRATE;ORAL

SINEQUAN

DISC PFIZER

10MG BASE
25MG BASE
50MG BASE
75MG BASE
100MG BASE
150MG BASE

EQ 10MG BASE/ML

016798
016798
016798
016798
016798
016798

003
001
002
006
005
007

Jul
Jul
Jul
Jul
Jul
Jul

22,
22,
22,
22,
22,
22,

2011 Current
2011 Current
2011 Current
2011 Current
2011 Current
2011 Current

OB:NO

OB:NO

OB:NO

OB:NO

OB:NO

OB:NO

N 017516 001 Jul 22, 2011 Current OB:NO


DOXYCYCLINE HYCLATE

CAPSULE, DELAYED RELEASE;ORAL

DORYX

DISC MAYNE PHARMA INTL
EQ 75MG BASE
DISC
EQ 100MG BASE
CAPSULE;ORAL

PERIOSTAT

DISC COLLAGENEX
EQ 20MG BASE
TABLET;ORAL

PERIOSTAT

DISC GALDERMA LABS LP
EQ 20MG BASE
VIBRA-TABS

DISC PFIZER
EQ 100MG BASE

N 050533 001 Aug 14, 2014 Current OB:YES


DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL



BENDECTIN

DISC SANOFI AVENTIS US
10MG;10MG

N 010598 002 Jul 10, 1996 Current OB:YES


DYCLONINE HYDROCHLORIDE

SOLUTION;TOPICAL

DYCLONE

DISC ASTRAZENECA
0.5%
DISC
1%

N 009925 002 Nov 16, 2004 Current OB:YES



N 009925 001 Nov 16, 2004 Current OB:YES

EDROPHONIUM CHLORIDE

INJECTABLE;INJECTION

TENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA
10MG/ML
INC

N 050582 002 Dec 19, 2008 Current OB:NO



N 050582 001 Dec 19, 2008 Current OB:NO

N 050744 001 May 16, 2005 Current OB:NO


N 050783 001 Jan 26, 2015 Current OB:YES


N 007959 002 Oct 30, 2015 Current OB:YES


Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
EFAVIRENZ

CAPSULE;ORAL

SUSTIVA

DISC BRISTOL MYERS
SQUIBB

TABLET;ORAL

SUSTIVA

DISC BRISTOL MYERS
SQUIBB

Page 16 of 40

100MG

N 020972 002 Jun 15, 2012 Current OB:YES


300MG

N 021360 001 Feb 02, 2007 Current OB:YES


ENOXAPARIN SODIUM

INJECTABLE;SUBCUTANEOUS

LOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US


90MG/0.6ML (150MG/ML)

N 020164 006 Mar 08, 2004 Current OB:YES


ERYTHROMYCIN

SOLUTION;TOPICAL

STATICIN

DISC WESTWOOD SQUIBB
T-STAT

DISC WESTWOOD SQUIBB

1.5%

N 050526 001 Jan 21, 2016 Current OB:YES


2%

A 062436 001 Jan 21, 2016 Current OB:YES


ESMOLOL HYDROCHLORIDE

INJECTABLE;INJECTION

BREVIBLOC

RX
BAXTER HLTHCARE

10MG/ML

N 019386 006 Aug 04, 2004 Current OB:NO


ESTAZOLAM

TABLET;ORAL

PROSOM

DISC ABBOTT
DISC

1MG
2MG

N 019080 001 May 14, 2009 Current OB:YES



N 019080 002 May 14, 2009 Current OB:YES

0.5MG

A 081295 001 Nov 12, 2013 Current OB:NO


1MG
2MG

A 084499 001 Nov 12, 2013 Current OB:NO



A 084500 001 Nov 12, 2013 Current OB:NO

25MCG

N 020908 001 May 22, 2015 Current OB:YES


ESTRADIOL

TABLET;ORAL

ESTRACE

DISC BRISTOL MYERS
SQUIBB

DISC
DISC
TABLET;VAGINAL

VAGIFEM

DISC NOVO NORDISK INC

ESTRADIOL; NORGESTIMATE

TABLET;ORAL

PREFEST

DISC TEVA WOMENS
1MG,1MG;1MG,1MG;N/A,0.09MG

N 021040 001 Jan 26, 2015 Current OB:YES


ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE



TABLET;ORAL-21

DEMULEN 1/35-21

DISC GD SEARLE LLC


0.035MG;1MG
TABLET;ORAL-28

DEMULEN 1/35-28

DISC GD SEARLE LLC


0.035MG;1MG
DEMULEN 1/50-28

DISC GD SEARLE LLC


0.05MG;1MG

N 016936 001 Dec 05, 2011 Current OB:NO


ETHINYL ESTRADIOL; LEVONORGESTREL



TABLET;ORAL

LYBREL

DISC WYETH PHARMS INC
0.02MG;0.09MG

N 021864 001 Oct 27, 2014 Current OB:YES


N 018168 001 Dec 05, 2011 Current OB:YES


N 018160 001 Dec 05, 2011 Current OB:NO


Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
TABLET;ORAL-21
ALESSE
DISC WYETH PHARMS
LEVLITE
DISC BAYER HLTHCARE
TRIPHASIL-21
DISC WYETH PHARMS
TABLET;ORAL-28
ALESSE
DISC WYETH PHARMS
LEVLITE
DISC BAYER HLTHCARE
NORDETTE-28
DISC TEVA BRANDED PHARM
TRIPHASIL-28
DISC WYETH PHARMS INC

Page 17 of 40

0.02MG;0.1MG

N 020683 001 Mar 11, 2010 Current OB:YES

0.02MG;0.1MG

N 020860 001 Mar 11, 2010 Current OB:NO

0.03MG;0.03MG;0.04MG;0.05MG;0.0 N 019192 001 Dec 05, 2011 Current OB:YES


75MG;0.125MG

0.02MG;0.1MG

N 020683 002 Mar 11, 2010 Current OB:NO

0.02MG;0.1MG

N 020860 002 Mar 11, 2010 Current OB:NO

0.03MG;0.15MG

N 018782 001 Dec 04, 2015 Current OB:YES

0.03MG;0.03MG;0.04MG;0.05MG;0.0 N 019190 001 Dec 05, 2011 Current OB:NO


75MG;0.125MG

ETHINYL ESTRADIOL; NORELGESTROMIN


FILM, EXTENDED RELEASE;TRANSDERMAL
ORTHO EVRA
DISC JANSSEN PHARMS
0.035MG/24HR;0.15MG/24HR
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET;ORAL-21
ORTHO-NOVUM 10/11-21
DISC ORTHO MCNEIL
0.035MG;0.035MG;0.5MG;1MG
JANSSEN
OVCON-35
0.035MG;0.4MG
DISC WARNER CHILCOTT
TABLET;ORAL-28
ORTHO-NOVUM 10/11-28
DISC ORTHO MCNEIL
0.035MG;0.035MG;0.5MG;1MG
JANSSEN
OVCON-35
DISC WARNER CHILCOTT
0.035MG;0.4MG
LLC

N 021180 001 Sep 29, 2015 Current OB:YES

N 018354 001 Aug 10, 2010 Current OB:NO

N 018127 001 Apr 04, 2016 Current OB:YES

N 018354 002 Aug 10, 2010 Current OB:NO

N 017716 001 Dec 04, 2015 Current OB:YES

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE


TABLET;ORAL
FEMHRT
DISC ALLERGAN PHARMS
0.005MG;1MG
N 021065 002 Aug 19, 2013 Current OB:NO
INTL
LOESTRIN 24 FE
RX
WARNER CHILCOTT
0.02MG;1MG
N 021871 001 Jul 20, 2015 Current OB:NO
TABLET;ORAL-21
ESTROSTEP 21
DISC ALLERGAN PHARMS
0.02MG;0.035MG;0.03MG;1MG;1MG;1 N 020130 001 May 23, 2007 Current OB:NO
INTL
MG
ETODOLAC
CAPSULE;ORAL
LODINE
DISC WYETH PHARMS
TABLET, EXTENDED
LODINE XL
DISC WYETH PHARMS
TABLET;ORAL
LODINE
DISC WYETH PHARMS
DISC

INC
200MG
RELEASE;ORAL

N 018922 002 May 23, 2007 Current OB:NO

INC

600MG

N 020584 002 May 23, 2007 Current OB:NO

INC

400MG
500MG

N 018922 004 May 23, 2007 Current OB:NO


N 018922 005 May 23, 2007 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Page 18 of 40

ETOPOSIDE

INJECTABLE;INJECTION

VEPESID

DISC CORDEN PHARMA

20MG/ML

N 018768 001 Mar 02, 2011 Current OB:NO


EVANS BLUE

INJECTABLE;INJECTION

EVANS BLUE

DISC PARKE DAVIS

0.5%

N 008041 001 Nov 15, 1996 Current OB:YES


FAMOTIDINE

INJECTABLE;INJECTION

PEPCID

DISC MERCK
10MG/ML
PEPCID PRESERVATIVE FREE

DISC MERCK
10MG/ML
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME
0.4MG/ML
FELODIPINE

TABLET, EXTENDED RELEASE;ORAL

PLENDIL

DISC ASTRAZENECA
2.5MG
DISC
5MG
DISC
10MG
FENOFIBRATE

CAPSULE;ORAL

TRICOR (MICRONIZED)

DISC ABBVIE
DISC
DISC
TABLET;ORAL

TRICOR

DISC ABBOTT
DISC

N 019510 001 Aug 19, 2013 Current OB:NO



N 019510 004 Aug 19, 2013 Current OB:NO

N 020249 001 Aug 19, 2013 Current OB:NO

N 019834 004 Mar 15, 2016 Current OB:YES



N 019834 001 Mar 15, 2016 Current OB:YES

N 019834 002 Mar 15, 2016 Current OB:YES

67MG
134MG
200MG

N 019304 002 Oct 10, 2003 Current OB:NO



N 019304 003 Oct 10, 2003 Current OB:NO

N 019304 004 Oct 10, 2003 Current OB:NO

54MG
160MG

N 021203 001 Sep 06, 2007 Current OB:NO



N 021203 003 Sep 06, 2007 Current OB:NO

FENTANYL CITRATE

TABLET;BUCCAL, SUBLINGUAL

FENTORA

DISC CEPHALON
EQ 0.3MG BASE

N 021947 006 Apr 11, 2011 Current OB:NO


FLECAINIDE ACETATE

TABLET;ORAL

TAMBOCOR

DISC CNTY LINE PHARMS
DISC
DISC

50MG
100MG
150MG

N 018830 004 Nov 12, 2013 Current OB:NO



N 018830 001 Nov 12, 2013 Current OB:NO

N 018830 003 Nov 12, 2013 Current OB:NO

FLOXURIDINE

INJECTABLE;INJECTION

FUDR

DISC HOSPIRA

500MG/VIAL

N 016929 001 May 14, 2009 Current OB:YES


FLUDARABINE PHOSPHATE

INJECTABLE;INJECTION

FLUDARA

DISC GENZYME CORP

50MG/VIAL

N 020038 001 Sep 27, 2012 Current OB:NO


FLUDEOXYGLUCOSE F-18

INJECTABLE;INJECTION

FLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL
4-40mCi/ML
DISC
4-90mCi/ML

N 020306 001 Oct 01, 2008 Current OB:YES



N 020306 002 Oct 01, 2008 Current OB:YES

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Page 19 of 40

INJECTABLE;INTRAVENOUS

FLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL
10-100mCi/ML

N 021768 001 Jan 09, 2015 Current OB:YES


FLUDROCORTISONE ACETATE

TABLET;ORAL

FLORINEF

DISC CASPER PHARMA LLC
0.1MG

N 010060 001 Dec 19, 2008 Current OB:NO


FLUMAZENIL

INJECTABLE;INJECTION

ROMAZICON

DISC HOFFMANN LA ROCHE
DISC

1MG/10ML (0.1MG/ML)
0.5MG/5ML (0.1MG/ML)

N 020073 001 Aug 14, 2014 Current OB:YES



N 020073 002 Aug 14, 2014 Current OB:YES

0.05%

N 016908 002 Aug 19, 2013 Current OB:NO


0.05%

N 016908 003 Aug 19, 2013 Current OB:NO


0.05%

N 017373 001 Aug 14, 2014 Current OB:YES


0.05%

N 016909 002 Aug 14, 2014 Current OB:YES


FLUOCINONIDE

CREAM;TOPICAL

LIDEX

DISC CNTY LINE PHARMS
LIDEX-E

DISC CNTY LINE PHARMS
GEL;TOPICAL

LIDEX

DISC CNTY LINE PHARMS
OINTMENT;TOPICAL

LIDEX

DISC CNTY LINE PHARMS

FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL

SARAFEM

DISC ELI LILLY AND CO
EQ
DISC
EQ
SOLUTION;ORAL

PROZAC

DISC LILLY
EQ
TABLET;ORAL

PROZAC

DISC LILLY
EQ
DISC
EQ

10MG BASE
20MG BASE

N 018936 007 Jul 20, 2015 Current OB:YES



N 018936 008 Jul 20, 2015 Current OB:YES

20MG BASE/5ML

N 020101 001 Mar 11, 2010 Current OB:NO


10MG BASE
20MG BASE

N 020974 001 Jun 21, 2000 Current OB:NO



N 020974 002 Jun 21, 2000 Current OB:NO

FLURANDRENOLIDE

OINTMENT;TOPICAL

CORDRAN

DISC AQUA PHARMS
RX

0.025%
0.05%

N 012806 004 Jun 11, 2013 Current OB:YES



N 012806 001 Jun 11, 2013 Current OB:NO

FLUTICASONE PROPIONATE

CREAM;TOPICAL

CUTIVATE

DISC FOUGERA PHARMS

0.05%

N 019958 001 Jan 09, 2015 Current OB:YES


FOSAPREPITANT DIMEGLUMINE

POWDER;INTRAVENOUS

EMEND

DISC MERCK AND CO INC
EQ 115MG BASE/VIAL
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

TABLET;ORAL

MONOPRIL-HCT

DISC BRISTOL MYERS
10MG;12.5MG
SQUIBB

DISC
20MG;12.5MG

N 022023 001 Feb 18, 2014 Current OB:YES


N 020286 002 Mar 11, 2010 Current OB:NO



N 020286 001 Mar 11, 2010 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Page 20 of 40

FOSPHENYTOIN SODIUM

INJECTABLE;INJECTION

CEREBYX

RX
PARKE DAVIS

EQ 50MG PHENYTOIN NA/ML

N 020450 001 Mar 02, 2011 Current OB:NO


FUROSEMIDE

INJECTABLE;INJECTION

LASIX

DISC SANOFI AVENTIS US

10MG/ML

N 016363 001 May 23, 2007 Current OB:NO


GALLIUM NITRATE

INJECTABLE;INJECTION

GANITE

DISC CHAPTER 7 TRUSTEE

25MG/ML

N 019961 002 Feb 18, 2014 Current OB:YES


GANCICLOVIR

CAPSULE;ORAL

CYTOVENE

DISC ROCHE PALO
DISC

250MG
500MG

N 020460 001 Apr 28, 2008 Current OB:YES



N 020460 002 Apr 28, 2008 Current OB:YES

GANCICLOVIR SODIUM

INJECTABLE;INJECTION

CYTOVENE

RX
ROCHE PALO

EQ 500MG BASE/VIAL

N 019661 001 Jun 15, 2009 Current OB:NO


GENTAMICIN SULFATE

CREAM;TOPICAL

GARAMYCIN

DISC SCHERING
EQ 0.1% BASE
SOLUTION/DROPS;OPHTHALMIC

GARAMYCIN

DISC SCHERING
EQ 0.3% BASE

A 060462 001 Feb 18, 2004 Current OB:NO


N 050039 002 Feb 18, 2014 Current OB:YES


GLIMEPIRIDE; ROSIGLITAZONE MALEATE



TABLET;ORAL

AVANDARYL

DISC SB PHARMCO
1MG;4MG
DISC
2MG;4MG
DISC
2MG;8MG
DISC
4MG;4MG
DISC
4MG;8MG

N
N
N
N
N

GLUCAGON HYDROCHLORIDE

INJECTABLE;INJECTION

GLUCAGON

DISC LILLY
DISC

EQ 1MG BASE/VIAL
EQ 10MG BASE/VIAL

N 012122 001 Sep 09, 2015 Current OB:YES



N 012122 002 Sep 09, 2015 Current OB:YES

4.5MG

N 020051 003 Nov 15, 1996 Current OB:NO


1.25MG

N 017498 001 Mar 11, 2010 Current OB:NO


5MG

N 017498 003 Mar 11, 2010 Current OB:NO


GLYBURIDE

TABLET;ORAL

GLYNASE

DISC PHARMACIA AND
UPJOHN

MICRONASE

DISC PHARMACIA AND
UPJOHN

DISC

GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLUCOVANCE

DISC BRISTOL MYERS
1.25MG;250MG
SQUIBB

021700
021700
021700
021700
021700

001
002
004
003
005

Oct
Oct
Oct
Oct
Oct

30,
30,
30,
30,
30,

2015 Current
2015 Current
2015 Current
2015 Current
2015 Current

OB:YES

OB:YES

OB:YES

OB:YES

OB:YES

N 021178 001 Jan 21, 2016 Current OB:YES


Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION

KYTRIL

EQ 0.1MG BASE/ML (EQ 0.1MG
DISC ROCHE

BASE/ML)

EQ 1MG BASE/ML (EQ 1MG BASE/ML)


DISC

EQ 3MG BASE/ML

DISC

EQ 4MG BASE/4ML (EQ 1MG

DISC

BASE/ML)

SOLUTION;ORAL

KYTRIL

EQ 2MG BASE/10ML

DISC ROCHE

TABLET;ORAL

KYTRIL

EQ 1MG BASE

DISC ROCHE

EQ 2MG BASE

DISC

GRISEOFULVIN, MICROCRYSTALLINE

SUSPENSION;ORAL

GRIFULVIN V

DISC JOHNSON AND
125MG/5ML

JOHNSON

TABLET;ORAL

GRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG

Page 21 of 40

N 020239 003 Oct 27, 2014


Current OB:YES

N 020239 004 Oct 27, 2014
Current OB:YES

N 020239 001 Oct 27, 2014
Current OB:YES

N 020239 002 Oct 27, 2014
Current OB:YES

N 021238 001 Jun 15, 2009


Current OB:NO

N 020305 001 Dec 28, 2015


Current OB:YES

N 020305 002 Dec 28, 2015
Current OB:YES

N 050448 001 Jul 20, 2015


Current OB:YES

A 062279 002 May 01, 2012


Current OB:YES

GRISEOFULVIN, MICROSIZE

SUSPENSION;ORAL

GRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG/5ML

A 062483 001 Jul 20, 2015


Current OB:YES

HALOPERIDOL

TABLET;ORAL

HALDOL

DISC ORTHO MCNEIL

DISC

DISC

DISC

DISC

DISC

N
N
N
N
N
N

0.5MG

1MG

2MG

5MG

10MG

20MG

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

SYRUP;ORAL

HYCODAN

1.5MG/5ML;5MG/5ML

DISC ENDO PHARMS

TABLET;ORAL

HYCODAN

1.5MG;5MG

DISC ENDO PHARMS

015921
015921
015921
015921
015921
015921

001
002
003
004
005
006

Aug
Aug
Aug
Aug
Aug
Aug

06,
06,
06,
06,
06,
06,

2003
Current
2003
Current
2003
Current
2003
Current
2003
Current
2003
Current

OB:NO

OB:NO

OB:NO

OB:NO

OB:NO

OB:NO

N 005213 002 Dec 30, 2011


Current OB:NO

N 005213 001 Dec 30, 2011


Current OB:NO

HYALURONIDASE

INJECTABLE;INJECTION

WYDASE

DISC BAXTER HLTHCARE

DISC

150 UNITS/VIAL

1,500 UNITS/VIAL

N 006343 006 Nov 06, 2003


Current OB:YES

N 006343 005 Nov 06, 2003
Current OB:YES

HYDROCHLOROTHIAZIDE

TABLET;ORAL

HYDRODIURIL

DISC MERCK

DISC

DISC

25MG

50MG

100MG

N 011835 003 Aug 06, 2003


Current OB:NO

N 011835 006 Aug 06, 2003
Current OB:NO

N 011835 007 Aug 06, 2003
Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Page 22 of 40

HYDROCHLOROTHIAZIDE; IRBESARTAN

TABLET;ORAL

AVALIDE

DISC SANOFI AVENTIS US
12.5MG;75MG

DISC
25MG;300MG

N 020758 001 Jan 11, 2012


Current OB:YES

N 020758 004 Jan 11, 2012
Current OB:YES

HYDROCHLOROTHIAZIDE; LISINOPRIL

TABLET;ORAL

PRINZIDE

DISC MERCK
25MG;20MG

N 019778 002 Dec 19, 2008


Current OB:YES

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

TABLET;ORAL

LOPRESSOR HCT

DISC US PHARMS HOLDINGS
50MG;100MG

I

HYDROCORTISONE ACETATE

OINTMENT;TOPICAL

CORTEF ACETATE

DISC PHARMACIA AND

UPJOHN

2.5%

HYDROCORTISONE VALERATE

CREAM;TOPICAL

WESTCORT

0.2%

DISC RANBAXY

OINTMENT;TOPICAL

WESTCORT

DISC RANBAXY

0.2%

HYDROXYPROGESTERONE CAPROATE

INJECTABLE;INJECTION

DELALUTIN

125MG/ML

DISC BRISTOL MYERS
SQUIBB
125MG/ML

DISC
250MG/ML

DISC
250MG/ML

DISC

N 018303 003 Aug 10, 2010


Current OB:NO

N 008917 001 Sep 26, 2001


Current OB:YES

N 017950 001 Sep 27, 2012


Current OB:NO

N 018726 001 Nov 12, 2013


Current OB:NO

N 010347 004 Jun 25, 2010


Current OB:YES

N 016911 001 Jun 25, 2010
Current OB:YES

N 010347 002 Jun 25, 2010
Current OB:YES

N 016911 002 Jun 25, 2010
Current OB:YES

HYDROXYZINE PAMOATE

CAPSULE;ORAL

VISTARIL

DISC PFIZER

EQ 100MG HCL

N 011459 006 Apr 28, 2008


Current OB:NO

IBANDRONATE SODIUM

TABLET;ORAL

BONIVA

DISC HOFFMANN LA ROCHE

EQ 2.5MG BASE

N 021455 001 Mar 11, 2010


Current OB:YES

IFOSFAMIDE

INJECTABLE;INJECTION

IFEX

RX
BAXTER HLTHCARE

RX

1GM/VIAL

3GM/VIAL

N 019763 001 May 14, 2002


Current OB:NO

N 019763 002 May 14, 2002
Current OB:NO

IMATINIB MESYLATE

CAPSULE;ORAL

GLEEVEC

DISC NOVARTIS

DISC

EQ 50MG BASE

EQ 100MG BASE

N 021335 001 Dec 07, 2010


Current OB:NO

N 021335 002 Dec 07, 2010
Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
INDAPAMIDE

TABLET;ORAL

LOZOL

DISC SANOFI AVENTIS US
DISC

1.25MG
2.5MG

INDOMETHACIN

CAPSULE, EXTENDED RELEASE;ORAL

INDOCIN SR

DISC IROKO PHARMS
75MG
CAPSULE;ORAL

INDOCIN

DISC IROKO PHARMS LLC
25MG
DISC
50MG
SUPPOSITORY;RECTAL

INDOCIN

DISC IROKO PHARMS
50MG
IPRATROPIUM BROMIDE

SOLUTION;INHALATION

ATROVENT

DISC BOEHRINGER
INGELHEIM

Page 23 of 40

N 018538 002 May 14, 2009 Current OB:YES



N 018538 001 May 14, 2009 Current OB:YES

N 018185 001 Mar 15, 2016 Current OB:YES


N 016059 001 Mar 15, 2016 Current OB:YES



N 016059 002 Mar 15, 2016 Current OB:YES

N 017814 001 Aug 06, 2003 Current OB:NO


0.02%

N 020228 001 Oct 01, 2008 Current OB:NO


10MG

N 012093 002 Jul 20, 2015 Current OB:YES

20MG
30MG

N 012093 006 Jul 20, 2015 Current OB:YES


N 012093 005 Jul 20, 2015 Current OB:YES

ISOSORBIDE DINITRATE

TABLET;ORAL

ISORDIL

DISC VALEANT PHARMS
NORTH
DISC
DISC
TABLET;SUBLINGUAL
ISORDIL
DISC BIOVAIL
DISC
DISC
ISOSORBIDE DINITRATE
DISC WATSON LABS
DISC

2.5MG
5MG
10MG

N 012940 004 Jun 15, 2009 Current OB:NO


N 012940 003 Jun 15, 2009 Current OB:NO
N 012940 005 Jun 15, 2009 Current OB:YES

2.5MG
5MG

A 086033 001 Aug 19, 2013 Current OB:YES


A 086031 001 Aug 19, 2013 Current OB:YES

ISOSULFAN BLUE
INJECTABLE;INJECTION
LYMPHAZURIN
DISC COVIDIEN

1%

N 018310 001 Jan 26, 2015 Current OB:YES

ISOTRETINOIN
CAPSULE;ORAL
ACCUTANE
DISC HOFFMANN LA ROCHE
DISC
DISC

10MG
20MG
40MG

N 018662 002 Jul 07, 2010 Current OB:NO


N 018662 004 Jul 07, 2010 Current OB:NO
N 018662 003 Jul 07, 2010 Current OB:NO

ISRADIPINE
TABLET, EXTENDED RELEASE;ORAL
DYNACIRC CR
DISC GLAXOSMITHKLINE
5MG
LLC
DISC
10MG
KETOPROFEN
CAPSULE, EXTENDED RELEASE;ORAL
ORUVAIL
DISC WYETH PHARMS INC
150MG
DISC
200MG

N 020336 001 Nov 12, 2013 Current OB:YES


N 020336 002 Nov 12, 2013 Current OB:YES

N 019816 002 Dec 19, 2008 Current OB:NO


N 019816 001 Dec 19, 2008 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
CAPSULE;ORAL
ORUDIS
DISC WYETH AYERST
DISC
DISC

25MG
50MG
75MG

KETOROLAC TROMETHAMINE
INJECTABLE;INJECTION
KETOROLAC TROMETHAMINE
15MG/ML
DISC BEDFORD
30MG/ML
DISC
30MG/ML
DISC
TORADOL
15MG/ML
DISC ROCHE PALO
30MG/ML
DISC
TABLET;ORAL
TORADOL
DISC ROCHE PALO
10MG
LABETALOL HYDROCHLORIDE
INJECTABLE;INJECTION
TRANDATE
DISC SEBELA IRELAND LTD 5MG/ML
LACTULOSE
SOLUTION;ORAL
CHRONULAC
DISC SANOFI AVENTIS US
SOLUTION;ORAL, RECTAL
CEPHULAC
DISC SANOFI AVENTIS US

Page 24 of 40

N 018754 001 Apr 28, 2008 Current OB:NO


N 018754 002 Apr 28, 2008 Current OB:NO
N 018754 003 Apr 28, 2008 Current OB:NO

A 075222 001 Oct 27, 2014 Current OB:YES


A 075222 002 Oct 27, 2014 Current OB:YES
A 075228 001 Oct 27, 2014 Current OB:YES
N 019698 001 Aug 04, 2004 Current OB:NO
N 019698 002 Aug 04, 2004 Current OB:NO

N 019645 001 Dec 19, 2008 Current OB:NO

N 019425 001 Mar 11, 2010 Current OB:NO

10GM/15ML

N 017884 001 Feb 18, 2004 Current OB:YES

10GM/15ML

N 017657 001 Aug 06, 2003 Current OB:NO

LANSOPRAZOLE; NAPROXEN
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
PREVACID NAPRAPAC 250 (COPACKAGED)
DISC TAKEDA PHARMS NA
15MG,N/A;N/A,250MG

N 021507 002 Aug 07, 2007 Current OB:YES

LEUCOVORIN CALCIUM
INJECTABLE;INJECTION
LEUCOVORIN CALCIUM PRESERVATIVE FREE
DISC HOSPIRA
EQ 10MG BASE/ML

A 040147 001 Jun 16, 2014 Current OB:YES

LEUPROLIDE ACETATE
INJECTABLE;INJECTION
LUPRON DEPOT
DISC ABBVIE ENDOCRINE
INC
LUPRON DEPOT-PED
DISC ABBVIE ENDOCRINE
INC
DISC

3.75MG/VIAL

N 020011 001 Oct 08, 2014 Current OB:YES

3.75MG/VIAL,7.5MG/VIAL;3.75MG/V N 020263 003 Aug 20, 2014 Current OB:YES


IAL,7.5MG/VIAL
7.5MG/VIAL,7.5MG/VIAL;7.5MG/VIA N 020263 004 Aug 20, 2014 Current OB:YES
L,7.5MG/VIAL

LEVOFLOXACIN
SOLUTION/DROPS;OPHTHALMIC
IQUIX
DISC SANTEN
1.5%
QUIXIN
DISC SANTEN
0.5%
LEVOLEUCOVORIN CALCIUM
SOLUTION;IV (INFUSION)
FUSILEV
DISC SPECTRUM PHARMS
EQ 175MG BASE/17.5ML (EQ 10MG
BASE/ML)
DISC
EQ 250MG BASE/25ML (EQ 10MG
BASE/ML)

N 021571 001 Jan 09, 2015 Current OB:YES


N 021199 001 Dec 04, 2015 Current OB:YES

N 020140 002 Aug 22, 2014 Current OB:YES


N 020140 003 Aug 22, 2014 Current OB:YES

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Page 25 of 40

LEVOMETHADYL ACETATE HYDROCHLORIDE



CONCENTRATE;ORAL

ORLAAM

DISC ROXANE
10MG/ML

N 020315 001 Jun 06, 2011 Current OB:YES


LEVONORGESTREL

IMPLANT;IMPLANTATION

JADELLE

DISC POPULATION COUNCIL 75MG/IMPLANT

N 020544 001 Aug 29, 2014 Current OB:YES


LEVOTHYROXINE SODIUM

TABLET;ORAL

LEVOXYL

DISC KING PHARMS R AND
D

LINEZOLID

TABLET;ORAL

ZYVOX

DISC PHARMACIA AND
UPJOHN

0.3MG

N 021301 012 Jun 15, 2009 Current OB:NO


400MG

N 021130 001 Jun 30, 2005 Current OB:YES


LITHIUM CARBONATE

TABLET, EXTENDED RELEASE;ORAL

ESKALITH CR

DISC JDS PHARMS
450MG

N 018152 001 Apr 28, 2008 Current OB:NO


LOVASTATIN

TABLET;ORAL

MEVACOR

DISC MERCK
DISC
DISC

10MG
20MG
40MG

N 019643 002 Mar 07, 2008 Current OB:NO


N 019643 003 Jan 21, 2016 Current OB:YES
N 019643 004 Jan 21, 2016 Current OB:YES

EQ 5MG BASE

N 017525 001 Sep 23, 2011 Current OB:NO


EQ 10MG BASE
EQ 25MG BASE

N 017525 002 Sep 23, 2011 Current OB:NO



N 017525 003 Sep 23, 2011 Current OB:NO

LOXAPINE SUCCINATE

CAPSULE;ORAL

LOXITANE

DISC ACTAVIS LABS UT
INC

DISC
DISC

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM

BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE

SOLUTION;ORAL

SUCLEAR

DISC BRAINTREE LABS
1.6GM;210GM;0.74GM;3.13GM;2.86G N 203595 001 Jan 21, 2016 Current OB:YES

M;5.6GM;17.5GM

MAZINDOL

TABLET;ORAL

SANOREX

DISC NOVARTIS
DISC

1MG
2MG

N 017247 001 Jul 15, 2008 Current OB:YES



N 017247 002 Jul 15, 2008 Current OB:YES

MEBENDAZOLE

TABLET, CHEWABLE;ORAL

VERMOX

DISC JANSSEN PHARMS
100MG

N 017481 001 Sep 06, 2007 Current OB:NO


MECAMYLAMINE HYDROCHLORIDE

TABLET;ORAL

INVERSINE

DISC TARGACEPT
2.5MG

N 010251 001 Jul 22, 2011 Current OB:NO


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FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

MEDROXYPROGESTERONE ACETATE

INJECTABLE;INJECTION

DEPO-PROVERA

DISC PHARMACIA AND
100MG/ML

UPJOHN

MEGESTROL ACETATE

TABLET;ORAL

MEGACE

DISC BRISTOL MYERS
SQUIBB

DISC
MEPHENYTOIN

TABLET;ORAL

MESANTOIN

DISC NOVARTIS

N 012541 002 Jan 27, 1998


Current OB:YES

20MG

N 016979 001 Mar 02, 2011


Current OB:NO

40MG

N 016979 002 Mar 02, 2011


Current OB:NO

100MG

N 006008 001 Dec 03, 2009


Current OB:YES

MEPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CARBOCAINE

DISC EASTMAN KODAK
3%

MEPROBAMATE

TABLET;ORAL

MILTOWN

DISC MEDPOINTE PHARM
HLC

DISC

Page 26 of 40

N 012125 003 Apr 28, 2008


Current OB:NO

200MG

N 009698 004 Sep 06, 2007


Current OB:NO

400MG

N 009698 002 Sep 06, 2007


Current OB:NO

MERCAPTOPURINE

TABLET;ORAL

PURINETHOL

DISC STASON PHARMS

50MG

N 009053 002 Dec 04, 2015


Current OB:YES

MESALAMINE

SUPPOSITORY;RECTAL

ROWASA

DISC MEDA PHARMS

500MG

N 019919 001 Feb 21, 2001


Current OB:NO

METARAMINOL BITARTRATE

INJECTABLE;INJECTION

ARAMINE

DISC MERCK

EQ 10MG BASE/ML

N 009509 002 Apr 28, 2008


Current OB:NO

METAXALONE

TABLET;ORAL

SKELAXIN

DISC KING PHARMS

400MG

N 013217 001 Apr 07, 2014


Current OB:YES

METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLUCOPHAGE

DISC BRISTOL MYERS
625MG

SQUIBB

DISC
750MG

N 020357 003 May 24, 2001


Current OB:NO

N 020357 004 Jun 20, 2001
Current OB:NO

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

TABLET;ORAL

AVANDAMET

DISC SB PHARMCO
500MG;EQ 1MG BASE

N 021410 001 Jan 09, 2015


Current OB:YES

METHIMAZOLE

TABLET;ORAL

TAPAZOLE

DISC KING PHARMS
DISC

N 007517 002 Apr 28, 2008


Current OB:NO

N 007517 004 Apr 28, 2008
Current OB:NO

5MG

10MG

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
METHOTREXATE SODIUM

INJECTABLE;INJECTION

METHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA
EQ 500MG BASE/20ML (EQ 25MG
BASE/ML)

Page 27 of 40

N 011719 013 Aug 08, 2007 Current OB:YES


METHYCLOTHIAZIDE

TABLET;ORAL

ENDURON

DISC ABBVIE
DISC

2.5MG
5MG

N 012524 001 Sep 27, 2012 Current OB:YES



N 012524 004 Sep 27, 2012 Current OB:NO

METHYLDOPA

TABLET;ORAL

ALDOMET

DISC MERCK
DISC
DISC

125MG
250MG
500MG

N 013400 003 May 23, 2007 Current OB:NO



N 013400 001 May 23, 2007 Current OB:NO

N 013400 002 May 23, 2007 Current OB:NO

METHYLDOPATE HYDROCHLORIDE

INJECTABLE;INJECTION

ALDOMET

DISC MERCK
50MG/ML

N 013401 001 May 23, 2007 Current OB:NO


METHYLPHENIDATE HYDROCHLORIDE

TABLET, CHEWABLE;ORAL

METHYLIN

DISC MALLINCKRODT
2.5MG
DISC
5MG
DISC
10MG
TABLET, EXTENDED RELEASE;ORAL

METADATE ER

DISC UCB INC
10MG

N 021475 001 Mar 15, 2016 Current OB:YES



N 021475 002 Mar 15, 2016 Current OB:YES

N 021475 003 Mar 15, 2016 Current OB:YES

METOCLOPRAMIDE HYDROCHLORIDE

SOLUTION;ORAL

REGLAN

DISC ROBINS AH
EQ 5MG BASE/5ML
TABLET, ORALLY DISINTEGRATING;ORAL

METOZOLV ODT

DISC SALIX PHARMS
EQ 10MG BASE

N 018821 001 May 14, 2009 Current OB:YES


MIDAZOLAM HYDROCHLORIDE

INJECTABLE;INJECTION

VERSED

DISC HLR
EQ 1MG BASE/ML
DISC
EQ 5MG BASE/ML
SYRUP;ORAL

VERSED

DISC ROCHE
EQ 2MG BASE/ML
MILRINONE LACTATE

INJECTABLE;INJECTION

PRIMACOR

DISC SANOFI AVENTIS US

EQ 1MG BASE/ML

MINOCYCLINE HYDROCHLORIDE

CAPSULE;ORAL

MINOCIN

DISC PRECISION DERMAT
EQ 75MG BASE
TABLET, EXTENDED RELEASE;ORAL

SOLODYN

DISC MEDICIS
EQ 45MG BASE
DISC
EQ 90MG BASE
DISC
EQ 135MG BASE

A 040306 001 Jul 05, 2013 Current OB:NO


N 022246 002 Aug 14, 2014 Current OB:YES


N 018654 002 Aug 06, 2003 Current OB:NO



N 018654 001 Aug 06, 2003 Current OB:NO

N 020942 001 Aug 06, 2003 Current OB:NO


N 019436 001 Aug 10, 2010 Current OB:NO


N 050649 003 Feb 29, 2008 Current OB:NO


N 050808 001 Nov 12, 2013 Current OB:NO



N 050808 002 Nov 12, 2013 Current OB:NO

N 050808 003 Nov 12, 2013 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
TABLET;ORAL

MINOCYCLINE HYDROCHLORIDE

EQ 50MG BASE

DISC TRIAX PHARMS

EQ 100MG BASE

DISC

MINOXIDIL

TABLET;ORAL

LONITEN

DISC PHARMACIA AND
UPJOHN
DISC
MITOMYCIN

INJECTABLE;INJECTION

MITOZYTREX

DISC SUPERGEN

MOLINDONE HYDROCHLORIDE

CAPSULE;ORAL

MOBAN

DISC ENDO PHARMS

DISC

DISC

TABLET;ORAL

MOBAN

DISC ENDO PHARMS

DISC

DISC

DISC

DISC

N 050451 003 May 21, 1998


Current OB:NO

N 050451 002 May 22, 1998
Current OB:NO

2.5MG

N 018154 001 Jun 15, 2009


Current OB:NO

10MG

N 018154 003 Jun 15, 2009


Current OB:NO

5MG/VIAL

N 050763 001 Aug 19, 2013


Current OB:NO

MITOXANTRONE HYDROCHLORIDE

INJECTABLE;INJECTION

NOVANTRONE

EQ 25MG BASE/12.5ML (EQ 2MG

DISC EMD SERONO



BASE/ML)

EQ 30MG BASE/15ML (EQ 2MG

DISC

BASE/ML)

MIVACURIUM CHLORIDE

SOLUTION;INTRAVENOUS

MIVACRON

DISC ABBVIE

Page 28 of 40

N 019297 002 Apr 13, 2011


Current OB:NO

N 019297 003 Apr 13, 2011
Current OB:NO

EQ 2MG BASE/ML (EQ 2MG BASE/ML) N 020098 001 Aug 07, 2007
Current OB:NO

5MG

10MG

25MG

N 017111 001 Nov 06, 2013


Current OB:YES

N 017111 002 Nov 06, 2013
Current OB:YES

N 017111 003 Nov 06, 2013
Current OB:YES

5MG

10MG

25MG

50MG

100MG

N
N
N
N
N

NABUMETONE

TABLET;ORAL

RELAFEN

DISC SMITHKLINE BEECHAM 500MG

750MG

DISC

NAFCILLIN SODIUM

INJECTABLE;INJECTION

UNIPEN

EQ 1GM BASE/VIAL

DISC WYETH AYERST



EQ 2GM BASE/VIAL

DISC

EQ 2GM BASE/VIAL

DISC

EQ 4GM BASE/VIAL

DISC

EQ 10GM BASE/VIAL

DISC

EQ 20GM BASE/VIAL

DISC

EQ 500MG BASE/VIAL

DISC

EQ 500MG BASE/VIAL

DISC

UNIPEN IN PLASTIC CONTAINER

DISC WYETH AYERST
EQ 1GM BASE/VIAL

017111
017111
017111
017111
017111

004
005
006
007
008

Nov
Nov
Nov
Nov
Nov

06,
06,
06,
06,
06,

2013
Current
2013
Current
2013
Current
2013
Current
2013
Current

OB:YES

OB:YES

OB:YES

OB:YES

OB:YES

N 019583 001 Mar 07, 2008


Current OB:NO

N 019583 002 Mar 07, 2008
Current OB:NO

A
A
N
N
N
N
A
N

062717
062717
050320
050320
050320
050320
062717
050320

002
004
003
004
005
006
001
001

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

15,
15,
15,
15,
15,
15,
15,
15,

2016
Current
2016
Current
2016
Current
2016
Current
2016
Current
2016
Current
2016
Current
2016
Current

OB:YES

OB:YES

OB:YES

OB:YES

OB:YES

OB:YES

OB:YES

OB:YES

N 050320 002 Mar 15, 2016


Current OB:YES

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
TABLET;ORAL
UNIPEN
DISC WYETH AYERST

EQ 500MG BASE

Page 29 of 40

N 050462 001 Feb 18, 2004 Current OB:YES

NALBUPHINE HYDROCHLORIDE
INJECTABLE;INJECTION
NUBAIN
DISC ENDO PHARMS
10MG/ML
DISC
20MG/ML

N 018024 001 Nov 21, 2008 Current OB:NO


N 018024 002 Nov 21, 2008 Current OB:NO

NALOXONE HYDROCHLORIDE
INJECTABLE;INJECTION
NARCAN
DISC ADAPT
DISC
DISC

0.02MG/ML
0.4MG/ML
1MG/ML

N 016636 002 May 14, 2009 Current OB:YES


N 016636 001 May 14, 2009 Current OB:YES
N 016636 003 May 14, 2009 Current OB:YES

NANDROLONE DECANOATE
INJECTABLE;INJECTION
DECA-DURABOLIN
DISC ASPEN GLOBAL INC

200MG/ML

N 013132 003 Aug 10, 2010 Current OB:NO

NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
ALBALON
DISC ALLERGAN
0.1%

A 080248 001 Jan 09, 2015 Current OB:YES

NIFEDIPINE
CAPSULE;ORAL
PROCARDIA
DISC PFIZER

20MG

N 018482 002 Mar 02, 2011 Current OB:NO

NIMODIPINE
CAPSULE;ORAL
NIMOTOP
DISC BAYER PHARMS

30MG

N 018869 001 Apr 02, 2014 Current OB:YES

NISOLDIPINE
TABLET, EXTENDED RELEASE;ORAL
SULAR
10MG
DISC SHIONOGI INC
20MG
DISC
25.5MG
DISC
30MG
DISC
40MG
DISC

N
N
N
N
N

NITRIC OXIDE
GAS;INHALATION
INOMAX
DISC MALLINCKRODT HOSP

N 020845 002 Jan 21, 2016 Current OB:YES

100PPM

NITROGLYCERIN
FILM, EXTENDED RELEASE;TRANSDERMAL
TRANSDERM-NITRO
0.1MG/HR
DISC NOVARTIS
0.2MG/HR
DISC
0.4MG/HR
DISC
0.6MG/HR
DISC
0.8MG/HR
DISC
INJECTABLE;INJECTION
NITROGLYCERIN
DISC HOSPIRA
5MG/ML

N
N
N
N
N

020356
020356
020356
020356
020356

020144
020144
020144
020144
020144

001
002
006
003
004

001
002
003
004
005

Aug
Aug
Aug
Aug
Aug

May
May
May
May
May

25,
25,
25,
25,
25,

23,
23,
23,
23,
23,

2014 Current
2014 Current
2014 Current
2014 Current
2014 Current

2007 Current
2007 Current
2007 Current
2007 Current
2007 Current

OB:YES
OB:YES
OB:YES
OB:YES
OB:YES

OB:NO
OB:NO
OB:NO
OB:NO
OB:NO

N 018531 001 Nov 12, 2013 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
NORTRIPTYLINE HYDROCHLORIDE
SOLUTION;ORAL
AVENTYL
DISC RANBAXY
EQ 10MG BASE/5ML
NYSTATIN
CREAM;TOPICAL
MYCOSTATIN
DISC DELCOR ASSET CORP
OINTMENT;TOPICAL
MYCOSTATIN
DISC DELCOR ASSET CORP
POWDER;TOPICAL
MYCOSTATIN
DISC DELCOR ASSET CORP
TABLET;ORAL
NILSTAT
DISC LEDERLE

Page 30 of 40

N 014685 001 Aug 14, 2014 Current OB:YES

100,000 UNITS/GM

A 060575 001 Dec 04, 2015 Current OB:YES

100,000 UNITS/GM

A 060571 001 Dec 04, 2015 Current OB:YES

100,000 UNITS/GM

A 060578 001 Dec 04, 2015 Current OB:YES

500,000 UNITS

A 061151 001 Mar 02, 2011 Current OB:NO

NYSTATIN; TRIAMCINOLONE ACETONIDE


CREAM;TOPICAL
MYCOLOG-II
DISC DELCOR ASSET CORP
100,000 UNITS/GM;0.1%
DISC
100,000 UNITS/GM;0.1%

A 060576 002 Mar 15, 2016 Current OB:YES


A 062606 001 Mar 15, 2016 Current OB:YES

ONDANSETRON HYDROCHLORIDE
INJECTABLE;INJECTION
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
DISC GLAXOSMITHKLINE
EQ 0.64MG BASE/ML

N 020403 001 Sep 23, 2011 Current OB:NO

OXACILLIN SODIUM
INJECTABLE;INJECTION
BACTOCILL
DISC GLAXOSMITHKLINE
DISC
DISC
DISC
DISC
OXACILLIN SODIUM
DISC APOTHECON
DISC
DISC
DISC
DISC

EQ
EQ
EQ
EQ
EQ

1GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL
10GM BASE/VIAL
500MG BASE/VIAL

A
A
A
A
A

061334
061334
061334
061334
061334

006
007
008
010
009

Apr
Apr
Apr
Apr
Apr

04,
04,
04,
04,
04,

2016 Current
2016 Current
2016 Current
2016 Current
2016 Current

OB:YES
OB:YES
OB:YES
OB:YES
OB:YES

EQ
EQ
EQ
EQ
EQ

1GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL

N
N
N
N
N

050195
050195
050195
050195
050195

003
004
005
001
002

Apr
Apr
Apr
Apr
Apr

04,
04,
04,
04,
04,

2016 Current
2016 Current
2016 Current
2016 Current
2016 Current

OB:YES
OB:YES
OB:YES
OB:YES
OB:YES

OXALIPLATIN
INJECTABLE;IV (INFUSION)
ELOXATIN
DISC SANOFI AVENTIS US
50MG/VIAL
DISC
100MG/VIAL

N 021492 001 Nov 26, 2007 Current OB:NO


N 021492 002 Nov 26, 2007 Current OB:NO

OXYBUTYNIN CHLORIDE
TABLET;ORAL
DITROPAN
DISC JANSSEN PHARMS

N 017577 001 Sep 27, 2012 Current OB:NO

5MG

OXYMORPHONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
OPANA ER
DISC ENDO PHARMS
7.5MG
DISC
15MG

N 021610 005 Aug 30, 2011 Current OB:NO


N 021610 006 Aug 30, 2011 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
OXYTOCIN

INJECTABLE;INJECTION

OXYTOCIN 10 USP UNITS IN DEXTROSE 5%

DISC ABBOTT
1USP UNITS/100ML
DISC
2USP UNITS/100ML
OXYTOCIN 20 USP UNITS IN DEXTROSE 5%

DISC ABBOTT
2USP UNITS/100ML
OXYTOCIN 5 USP UNITS IN DEXTROSE 5%

DISC ABBOTT
1USP UNITS/100ML
PACLITAXEL

INJECTABLE;INJECTION

TAXOL

RX
HQ SPCLT PHARMA

6MG/ML

Page 31 of 40

N 019185 004 Apr 22, 2015 Current OB:YES



N 019185 003 Apr 22, 2015 Current OB:YES

N 019185 002 Apr 22, 2015 Current OB:YES

N 019185 001 Apr 22, 2015 Current OB:YES

N 020262 001 Mar 02, 2011 Current OB:NO


PALIPERIDONE

TABLET, EXTENDED RELEASE;ORAL

INVEGA

DISC JANSSEN PHARMS
12MG

N 021999 004 Nov 04, 2013 Current OB:YES


PALONOSETRON HYDROCHLORIDE

CAPSULE;ORAL

ALOXI

DISC HELSINN HLTHCARE
EQ 0.5MG BASE

N 022233 001 Sep 04, 2012 Current OB:YES


PAMIDRONATE DISODIUM

INJECTABLE;INJECTION

AREDIA

DISC NOVARTIS
DISC
DISC

N 020036 001 Sep 27, 2012 Current OB:NO



N 020036 003 Sep 27, 2012 Current OB:NO

N 020036 004 Sep 27, 2012 Current OB:NO

30MG/VIAL
60MG/VIAL
90MG/VIAL

PAROXETINE HYDROCHLORIDE

CAPSULE;ORAL

PAXIL

DISC APOTEX
EQ
TECHNOLOGIES

DISC
EQ
DISC
EQ
DISC
EQ
PENBUTOLOL SULFATE

TABLET;ORAL

LEVATOL

DISC AUXILIUM PHARMS
INC

DISC

10MG BASE

N 020885 001 Jun 21, 2000 Current OB:YES


20MG BASE
30MG BASE
40MG BASE

N 020885 002 Jun 21, 2000 Current OB:YES



N 020885 003 Jun 21, 2000 Current OB:YES

N 020885 004 Jun 21, 2000 Current OB:YES

10MG

N 018976 001 Jan 09, 2015 Current OB:YES


20MG

N 018976 004 Jan 09, 2015 Current OB:YES


PENICILLIN G POTASSIUM

INJECTABLE;INJECTION

PENICILLIN G POTASSIUM

DISC SANDOZ
1,000,000 UNITS/VIAL
PFIZERPEN

DISC PFIZER
1,000,000 UNITS/VIAL

A 060657 001 Dec 05, 2014 Current OB:YES


PENTAGASTRIN

INJECTABLE;INJECTION

PEPTAVLON

DISC WYETH AYERST

N 017048 001 Feb 10, 2006 Current OB:YES


0.25MG/ML

PENTETATE CALCIUM TRISODIUM



SOLUTION;INHALATION, INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

DISC HAMELN PHARMA PLUS EQ 1GM BASE/5ML (EQ 200MG
BASE/ML)

A 065079 001 Dec 05, 2014 Current OB:YES


N 021749 001 Aug 19, 2011 Current OB:YES


Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
PENTETATE ZINC TRISODIUM

SOLUTION;INHALATION, INTRAVENOUS

PENTETATE ZINC TRISODIUM

DISC HAMELN PHARMA PLUS EQ 1GM BASE/5ML (EQ 200MG
BASE/ML)

Page 32 of 40

N 021751 001 Aug 19, 2011 Current OB:YES


PERPHENAZINE

TABLET;ORAL

TRILAFON

DISC SCHERING
DISC
DISC
DISC

2MG
4MG
8MG
16MG

N
N
N
N

PHENACEMIDE

TABLET;ORAL

PHENURONE

DISC ABBVIE

500MG

N 007707 001 Feb 29, 2012 Current OB:YES


010775
010775
010775
010775

001
002
003
004

Oct
Oct
Oct
Oct

10,
10,
10,
10,

2003 Current
2003 Current
2003 Current
2003 Current

OB:NO

OB:NO

OB:NO

OB:NO

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE

TABLET;ORAL

AZO GANTANOL

DISC ROCHE
100MG;500MG

N 013294 001 Jun 12, 2014 Current OB:YES


PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE

TABLET;ORAL

AZO GANTRISIN

DISC ROCHE
50MG;500MG

N 019358 001 Jun 12, 2014 Current OB:YES


PHENTERMINE HYDROCHLORIDE

TABLET;ORAL

WILPO

DISC SANDOZ
8MG

N 012737 001 Feb 13, 2012 Current OB:YES


PHENTERMINE RESIN COMPLEX



CAPSULE, EXTENDED RELEASE;ORAL

IONAMIN

DISC UCB INC
EQ 15MG BASE
DISC
EQ 30MG BASE

N 011613 004 Dec 19, 2008 Current OB:NO



N 011613 002 Dec 19, 2008 Current OB:NO

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHENERGAN VC

DISC ANI PHARMS
5MG/5ML;6.25MG/5ML

N 008604 003 Apr 28, 2008 Current OB:NO


PINDOLOL

TABLET;ORAL

VISKEN

DISC NOVARTIS
DISC

5MG
10MG

N 018285 001 Jun 15, 2009 Current OB:NO



N 018285 002 Jun 15, 2009 Current OB:NO

PIPERACILLIN SODIUM

INJECTABLE;INJECTION

PIPRACIL

DISC WYETH PHARMS INC
DISC
DISC
DISC

EQ
EQ
EQ
EQ

N
N
N
N

POTASSIUM CITRATE

FOR SOLUTION;ORAL

POTASSIUM CITRATE

DISC UT SW MEDCTR
DISC

10MEQ/PACKET
20MEQ/PACKET

2GM BASE/VIAL
3GM BASE/VIAL
4GM BASE/VIAL
40GM BASE/VIAL

050545
050545
050545
050545

002
003
004
006

Oct
Oct
Oct
Jul

29,
29,
29,
03,

2003 Current
2003 Current
2003 Current
2002 Current

OB:NO

OB:NO

OB:NO

OB:NO

N 019647 002 Oct 10, 2003 Current OB:YES



N 019647 001 Oct 23, 2013 Current OB:YES

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
PRAVASTATIN SODIUM

TABLET;ORAL

PRAVACHOL

DISC BRISTOL MYERS
SQUIBB

10MG

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

SOLUTION/DROPS;OPHTHALMIC

VASOCIDIN

DISC NOVARTIS
EQ 0.23% PHOSPHATE;10%
PROCAINAMIDE HYDROCHLORIDE

CAPSULE;ORAL

PRONESTYL

DISC APOTHECON
250MG
DISC
375MG
DISC
500MG
INJECTABLE;INJECTION

PRONESTYL

DISC APOTHECON
100MG/ML
DISC
500MG/ML
PROMETHAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

PHENERGAN

DISC WYETH AYERST
25MG/ML
DISC
50MG/ML
PROMETHAZINE HYDROCHLORIDE

DISC TEVA PHARMS USA
25MG/ML
DISC
50MG/ML
SUPPOSITORY;RECTAL

PHENERGAN

DISC DELCOR ASSET CORP
12.5MG
DISC
25MG
DISC
50MG
SYRUP;ORAL

PROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS
6.25MG/5ML
DISC
25MG/5ML
TABLET;ORAL

PHENERGAN

DISC DELCOR ASSET CORP
12.5MG
DISC
25MG
DISC
50MG
PROPANTHELINE BROMIDE

TABLET;ORAL

PRO-BANTHINE

DISC SHIRE
DISC

7.5MG
15MG

Page 33 of 40

N 019898 002 Jul 20, 2015 Current OB:YES


N 018988 001 Jul 20, 2015 Current OB:YES


N 007335 001 Apr 04, 2016 Current OB:YES



N 007335 004 Apr 04, 2016 Current OB:YES

N 007335 003 Apr 04, 2016 Current OB:YES

N 007335 002 Apr 04, 2016 Current OB:YES



N 007335 005 Apr 04, 2016 Current OB:YES

N 008857 002 May 23, 2007 Current OB:NO



N 008857 003 May 23, 2007 Current OB:NO

A 040454 001 Jul 20, 2015 Current OB:YES

A 040454 002 Jul 20, 2015 Current OB:YES

N 010926 002 Aug 06, 2007 Current OB:NO



N 010926 001 Aug 06, 2007 Current OB:NO

N 011689 001 Apr 28, 2008 Current OB:NO

N 008381 004 Apr 28, 2008 Current OB:NO



N 008381 003 Apr 28, 2008 Current OB:YES

N 007935 002 Jul 14, 2006 Current OB:NO



N 007935 003 Apr 28, 2008 Current OB:NO

N 007935 004 Jul 14, 2006 Current OB:NO

N 008732 003 Mar 11, 2010 Current OB:YES



N 008732 002 Mar 11, 2010 Current OB:NO

PROPARACAINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

OPHTHAINE

DISC APOTHECON
0.5%
OPHTHETIC

DISC ALLERGAN
0.5%

N 012583 001 Dec 04, 2015 Current OB:YES


PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL

INDERAL

DISC WYETH PHARMS INC
10MG
DISC
20MG
DISC
80MG

N 016418 001 Jan 09, 2008 Current OB:NO



N 016418 003 Jan 09, 2008 Current OB:NO

N 016418 004 Aug 14, 2014 Current OB:YES

N 008883 001 Dec 04, 2015 Current OB:YES


Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Page 34 of 40

TABLET;ORAL

INDERAL

DISC

90MG

N 016418 010 Jan 09, 2008 Current OB:YES


PROTAMINE SULFATE

INJECTABLE;INJECTION

PROTAMINE SULFATE

DISC LILLY

10MG/ML

N 006460 002 May 23, 2007 Current OB:NO


PYRIDOSTIGMINE BROMIDE

TABLET;ORAL

PYRIDOSTIGMINE BROMIDE

DISC SOLVAY
30MG

A 089572 001 Jun 21, 2005 Current OB:NO


QUETIAPINE FUMARATE

TABLET;ORAL

SEROQUEL

DISC ASTRAZENECA PHARMS EQ 150MG BASE

N 020639 004 Jan 25, 2008 Current OB:NO


RABEPRAZOLE SODIUM

TABLET, DELAYED RELEASE;ORAL

ACIPHEX

DISC EISAI INC
10MG

N 020973 001 Mar 28, 2005 Current OB:YES


RAMIPRIL

TABLET;ORAL

ALTACE

DISC KING PFIZER
DISC
DISC
DISC

N
N
N
N

1.25MG
2.5MG
5MG
10MG

RANITIDINE HYDROCHLORIDE

CAPSULE;ORAL

ZANTAC 150

DISC GLAXOSMITHKLINE
EQ 150MG BASE
ZANTAC 300

DISC GLAXOSMITHKLINE
EQ 300MG BASE
RISEDRONATE SODIUM

TABLET;ORAL

ACTONEL

DISC ALLERGAN PHARMS
INTL

ROCURONIUM BROMIDE

INJECTABLE;INJECTION

ZEMURON

DISC ORGANON USA INC
DISC
DISC

001
002
003
004

Nov
Nov
Nov
Nov

12,
12,
12,
12,

2013 Current
2013 Current
2013 Current
2013 Current

OB:NO

OB:NO

OB:NO

OB:NO

N 020095 001 Aug 06, 2003 Current OB:NO



N 020095 002 Aug 06, 2003 Current OB:NO

75MG

N 020835 004 Jul 07, 2010 Current OB:YES


50MG/5ML (10MG/ML)
10MG/ML (10MG/ML)
100MG/10ML (10MG/ML)

N 020214 001 Jan 26, 2015 Current OB:YES



N 020214 002 Jan 26, 2015 Current OB:YES

N 020214 003 Jan 26, 2015 Current OB:YES

ROPINIROLE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

REQUIP XL

DISC GLAXOSMITHKLINE
EQ 3MG BASE
LLC

RUFINAMIDE

TABLET;ORAL

BANZEL

DISC EISAI INC

022021
022021
022021
022021

100MG

N 022008 002 Feb 21, 2012 Current OB:NO


N 021911 001 Nov 21, 2013 Current OB:YES


Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Page 35 of 40

SAQUINAVIR

CAPSULE;ORAL

FORTOVASE

DISC HOFFMANN LA ROCHE

200MG

N 020828 001 Sep 23, 2011 Current OB:NO


SERMORELIN ACETATE

INJECTABLE;INJECTION

GEREF

DISC EMD SERONO
DISC EMD SERONO INC
DISC

EQ 0.05MG BASE/AMP
EQ 0.5MG BASE/VIAL
EQ 1MG BASE/VIAL

N 019863 001 Mar 04, 2013 Current OB:YES



N 020443 001 Mar 04, 2013 Current OB:YES

N 020443 002 Mar 04, 2013 Current OB:YES

SERTRALINE HYDROCHLORIDE

TABLET;ORAL

ZOLOFT

DISC PFIZER
EQ 150MG BASE
DISC
EQ 200MG BASE

N 019839 003 Sep 17, 2004 Current OB:NO



N 019839 004 Sep 17, 2004 Current OB:NO

SIMVASTATIN; SITAGLIPTIN
TABLET;ORAL

JUVISYNC

DISC MERCK SHARP DOHME
DISC
DISC
DISC
DISC
DISC

10MG;EQ
10MG;EQ
20MG;EQ
20MG;EQ
40MG;EQ
40MG;EQ

N
N
N
N
N
N

SIROLIMUS

TABLET;ORAL

RAPAMUNE

DISC PF PRISM CV

5MG

PHOSPHATE

50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE

SODIUM BICARBONATE

INJECTABLE;INJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC ABBOTT
0.9MEQ/ML
DISC
1MEQ/ML
SODIUM FLUORIDE F-18

INJECTABLE;INTRAVENOUS

FLUORINE F-18

DISC GE HEALTHCARE
2mCi/ML
SODIUM FLUORIDE F 18

DISC NIH NCI DCTD
10-200mCi/ML
SODIUM NITROPRUSSIDE

INJECTABLE;INJECTION

NITROPRESS

DISC ABBVIE
50MG/VIAL
SODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE
50MG/VIAL

202343
202343
202343
202343
202343
202343

004
001
005
002
006
003

Feb
Feb
Feb
Feb
Feb
Feb

18,
18,
18,
18,
18,
18,

2014 Current
2014 Current
2014 Current
2014 Current
2014 Current
2014 Current

OB:YES

OB:YES

OB:YES

OB:YES

OB:YES

OB:YES

N 021110 003 May 23, 2007 Current OB:YES


N 019443 001 Nov 29, 2004 Current OB:NO



N 019443 002 Nov 29, 2004 Current OB:NO

N 017042 001 Mar 10, 2000 Current OB:YES



N 022494 001 Jun 24, 2011 Current OB:NO

N 018450 001 Mar 15, 2016 Current OB:YES



N 018581 001 Feb 18, 2004 Current OB:YES

SODIUM TETRADECYL SULFATE



INJECTABLE;INJECTION

SOTRADECOL

DISC ELKINS SINN
1%
DISC
3%

N 005970 004 Nov 07, 2002 Current OB:YES



N 005970 005 Nov 07, 2002 Current OB:YES

SULFACETAMIDE SODIUM

OINTMENT;OPHTHALMIC

SODIUM SULAMYD

DISC SCHERING

N 005963 002 May 13, 2015 Current OB:YES


10%

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
SOLUTION/DROPS;OPHTHALMIC
SODIUM SULAMYD
DISC SCHERING
10%
DISC
30%

N 005963 001 May 13, 2015 Current OB:YES


N 005963 003 May 13, 2015 Current OB:YES

SULFAMETHOXAZOLE; TRIMETHOPRIM
SUSPENSION;ORAL
BACTRIM
DISC MUTUAL PHARM
200MG/5ML;40MG/5ML
BACTRIM PEDIATRIC
DISC MUTUAL PHARM
200MG/5ML;40MG/5ML
SEPTRA
DISC MONARCH PHARMS
200MG/5ML;40MG/5ML
SEPTRA GRAPE
DISC MONARCH PHARMS
200MG/5ML;40MG/5ML
SULFAMETHOXAZOLE AND TRIMETHOPRIM
DISC ANI PHARMS INC
200MG/5ML;40MG/5ML
SULFINPYRAZONE
CAPSULE;ORAL
ANTURANE
DISC NOVARTIS
TABLET;ORAL
ANTURANE
DISC NOVARTIS

Page 36 of 40

N 017560 001 Mar 15, 2016 Current OB:YES


N 017560 002 Mar 15, 2016 Current OB:YES
N 017598 001 Mar 15, 2016 Current OB:YES
N 017598 002 Mar 15, 2016 Current OB:YES
A 077612 001 Apr 04, 2016 Current OB:YES

200MG

N 011556 004 Jun 15, 2009 Current OB:YES

100MG

N 011556 003 Jun 15, 2009 Current OB:YES

SULINDAC
TABLET;ORAL
CLINORIL
DISC MERCK

150MG

N 017911 001 Mar 02, 2011 Current OB:YES

SUTILAINS
OINTMENT;TOPICAL
TRAVASE
DISC ABBOTT

82,000 UNITS/GM

N 012828 001 Oct 19, 1998 Current OB:YES

TAMOXIFEN CITRATE
TABLET;ORAL
NOLVADEX
DISC ASTRAZENECA
DISC

EQ 10MG BASE
EQ 20MG BASE

N 017970 001 Dec 19, 2008 Current OB:NO


N 017970 002 Dec 19, 2008 Current OB:NO

TECHNETIUM TC-99M SODIUM PERTECHNETATE


SOLUTION;INJECTION, ORAL
SODIUM PERTECHNETATE TC 99M
DISC GE HEALTHCARE
2-100mCi/ML
DISC MALLINCKRODT
10-60mCi/ML

N 017471 001 May 29, 2014 Current OB:YES


N 017725 001 May 29, 2014 Current OB:YES

TERAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
HYTRIN
DISC ABBOTT
DISC
DISC
DISC

N
N
N
N

TERBUTALINE SULFATE
INJECTABLE;INJECTION
BRETHINE
DISC AAIPHARMA LLC
TABLET;ORAL
BRETHINE
DISC LEHIGH VALLEY
DISC

EQ
EQ
EQ
EQ

1MG BASE
2MG BASE
5MG BASE
10MG BASE

020347
020347
020347
020347

001
002
003
004

Aug
Aug
Aug
Aug

14,
14,
14,
14,

2014 Current
2014 Current
2014 Current
2014 Current

OB:YES
OB:YES
OB:YES
OB:YES

1MG/ML

N 018571 001 Jul 19, 2007 Current OB:NO

2.5MG
5MG

N 017849 001 Dec 19, 2008 Current OB:NO


N 017849 002 Dec 19, 2008 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
THEOPHYLLINE

SOLUTION;ORAL

THEOPHYLLINE

DISC ROXANE

80MG/15ML

THIORIDAZINE HYDROCHLORIDE

TABLET;ORAL

MELLARIL

DISC NOVARTIS
10MG
DISC
15MG
DISC
25MG
DISC
50MG
DISC
100MG
DISC
150MG
DISC
200MG

Page 37 of 40

A 087449 001 Feb 22, 2011 Current OB:NO


N
N
N
N
N
N
N

011808
011808
011808
011808
011808
011808
011808

003
016
006
011
009
017
015

May
May
May
May
May
May
May

23,
23,
23,
23,
23,
23,
23,

2007 Current
2007 Current
2007 Current
2007 Current
2007 Current
2007 Current
2007 Current

OB:NO

OB:NO

OB:NO

OB:NO

OB:NO

OB:NO

OB:NO

THIOTEPA

INJECTABLE;INJECTION

THIOPLEX

DISC IMMUNEX
THIOTEPA

DISC TEVA PARENTERAL
DISC

15MG/VIAL

N 020058 001 Feb 18, 2004 Current OB:YES


15MG/VIAL
30MG/VIAL

A 075730 001 Apr 04, 2016 Current OB:YES



A 075730 002 Apr 04, 2016 Current OB:YES

TILUDRONATE DISODIUM

TABLET;ORAL

SKELID

DISC SANOFI AVENTIS US

EQ 200MG BASE

N 020707 001 Feb 18, 2014 Current OB:YES


TIZANIDINE HYDROCHLORIDE

TABLET;ORAL

ZANAFLEX

DISC ACORDA
EQ 2MG BASE
TOBRAMYCIN SULFATE

INJECTABLE;INJECTION

NEBCIN

DISC LILLY
EQ 1.2GM BASE/VIAL
DISC
EQ 10MG BASE/ML
DISC
EQ 40MG BASE/ML
TOBRAMYCIN SULFATE (PHARMACY BULK)

DISC HOSPIRA
EQ 40MG BASE/ML
TOLAZAMIDE

TABLET;ORAL

TOLINASE

DISC PHARMACIA AND
UPJOHN

DISC
DISC
TORSEMIDE

INJECTABLE;INJECTION

DEMADEX

DISC ROCHE
DISC

N 020397 002 May 14, 2009 Current OB:YES


N 050519 001 May 23, 2007 Current OB:NO



N 050477 005 May 23, 2007 Current OB:NO

A 062008 001 May 23, 2007 Current OB:NO

A 063116 001 Dec 04, 2015 Current OB:YES

100MG

N 015500 002 Jun 15, 2009 Current OB:YES


250MG
500MG

N 015500 004 Jun 15, 2009 Current OB:NO



N 015500 005 Jun 15, 2009 Current OB:NO

50MG/5ML (10MG/ML)
20MG/2ML (10MG/ML)

N 020137 002 Aug 17, 2009 Current OB:NO



N 020137 001 Aug 17, 2009 Current OB:NO

TRAMADOL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

RYZOLT

DISC PURDUE PHARMA
100MG
DISC
200MG
DISC
300MG

N 021745 001 Nov 12, 2013 Current OB:NO



N 021745 002 Nov 12, 2013 Current OB:NO

N 021745 003 Nov 12, 2013 Current OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
TRAVOPROST

SOLUTION/DROPS;OPHTHALMIC

IZBA

DISC ALCON LABS INC
0.003%
TRAVATAN

DISC ALCON PHARMS LTD
0.004%
TRAZODONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

OLEPTRO

DISC ANGELINI PHARMA
150MG
DISC
300MG
TABLET;ORAL

DESYREL

DISC PRAGMA PHARMS LLC
50MG
DISC
100MG
DISC
150MG
DISC
300MG
TRETINOIN

CAPSULE;ORAL

VESANOID

DISC ROCHE
TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

KENALOG

DISC DELCOR ASSET CORP
DISC
LOTION;TOPICAL

KENALOG

DISC DELCOR ASSET CORP
DISC
PASTE;DENTAL

KENALOG IN ORABASE

DISC DELCOR ASSET CORP

Page 38 of 40

N 204822 001 Jan 26, 2016 Current OB:YES



N 021257 001 Nov 16, 2011 Current OB:NO

N 022411 001 Oct 30, 2015 Current OB:YES



N 022411 002 Oct 30, 2015 Current OB:YES

N
N
N
N

018207
018207
018207
018207

001
002
003
004

Mar
Mar
Mar
Mar

11,
11,
11,
11,

2010 Current
2010 Current
2010 Current
2010 Current

OB:NO
OB:NO
OB:NO
OB:NO

10MG

N 020438 001 Sep 14, 2010 Current OB:NO


0.025%
0.1%

N 011601 003 Nov 12, 2013 Current OB:YES



N 011601 006 Nov 12, 2013 Current OB:YES

0.025%
0.1%

N 011602 003 Mar 15, 2016 Current OB:YES



N 011602 001 Mar 15, 2016 Current OB:YES

0.1%

N 012097 001 Mar 11, 2010 Current OB:NO


TRIAMCINOLONE DIACETATE

INJECTABLE;INJECTION

ARISTOCORT

DISC SANDOZ
40MG/ML

N 012802 001 Jul 11, 2007 Current OB:YES


TRIFLUOPERAZINE HYDROCHLORIDE

TABLET;ORAL

STELAZINE

DISC GLAXOSMITHKLINE
EQ 1MG BASE
DISC
EQ 2MG BASE
DISC
EQ 5MG BASE
DISC
EQ 10MG BASE

N
N
N
N

TRIHEXYPHENIDYL HYDROCHLORIDE

TABLET;ORAL

ARTANE

DISC LEDERLE
2MG
DISC
5MG

N 006773 005 May 23, 2007 Current OB:NO



N 006773 003 May 23, 2007 Current OB:NO

TRIMETHOPRIM

TABLET;ORAL

TRIMETHOPRIM

DISC TEVA

A 071259 001 Feb 18, 2014 Current OB:YES


200MG

011552
011552
011552
011552

001
002
003
004

Jun
Jun
Jun
Jun

15,
15,
15,
15,

2009 Current
2009 Current
2009 Current
2009 Current

OB:NO

OB:NO

OB:NO

OB:NO

Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016
TROSPIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

SANCTURA XR

DISC ALLERGAN
60MG
TABLET;ORAL

SANCTURA

DISC ALLERGAN
20MG

Page 39 of 40

N 022103 001 Dec 04, 2015 Current OB:YES


N 021595 001 Dec 04, 2015 Current OB:YES


VALPROIC ACID

CAPSULE, DELAYED RELEASE;ORAL

STAVZOR

DISC BIONPHARMA INC
125MG
DISC
250MG
DISC
500MG

N 022152 001 Feb 18, 2014 Current OB:YES



N 022152 002 Feb 18, 2014 Current OB:YES

N 022152 003 Feb 18, 2014 Current OB:YES

VANCOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION

VANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC
EQ 1GM BASE/VIAL
DISC
EQ 10GM BASE/VIAL
DISC
EQ 500MG BASE/VIAL

A 062812 002 Dec 17, 2015 Current OB:YES



A 062812 003 Dec 17, 2015 Current OB:YES

A 062812 001 Dec 17, 2015 Current OB:YES

VENLAFAXINE HYDROCHLORIDE

TABLET;ORAL

EFFEXOR

DISC WYETH PHARMS INC
EQ
DISC
EQ
DISC
EQ
DISC
EQ
DISC
EQ
DISC
EQ

N
N
N
N
N
N

ZIDOVUDINE

TABLET;ORAL

RETROVIR

DISC VIIV HLTHCARE

12.5MG BASE
25MG BASE
37.5MG BASE
50MG BASE
75MG BASE
100MG BASE

300MG

ZOLEDRONIC ACID

INJECTABLE;IV (INFUSION)

ZOMETA

DISC NOVARTIS
EQ 4MG BASE/VIAL

020151
020151
020151
020151
020151
020151

001
002
006
003
004
005

Jan
Jan
Jan
Jan
Jan
Jan

26,
26,
26,
26,
26,
26,

2015 Current
2015 Current
2015 Current
2015 Current
2015 Current
2015 Current

OB:YES

OB:YES

OB:YES

OB:YES

OB:YES

OB:YES

N 020518 002 Nov 12, 2013 Current OB:NO


N 021223 001 Apr 14, 2009 Current OB:YES


Approved Drug Product List - Orange Book


FR Notice Determination of Safety or Effectiveness List
*See List Footnote

March 2016

Orange Book Approved Products Report Total: 818

Page 40 of 40

Current Edition Footnote Count: 447


Annual Orange Book Preface 1.11 Discontinued Section



Those drug products in the Discontinued Section of the Orange Book in which a determination has

already been made that the products were not withdrawn for safety or efficacy reasons have

**Federal Register determination that product was not discontinued or withdrawn for safety or

efficacy reasons** following the product strength. Those drug products are only reflective of

citizen petitions determinations made since 1995. The identification of these drug products in the

Discontinued Section of the Orange Book should avoid the submission of multiple citizen petitions

for the same drug product. FR notices no longer applicable are removed from the Annual Edition

(i.e., there is a currently marketed Reference Listed Drug and no applicable patent or

exclusivity). http://www.fda.gov/cder/ogd/OrangeBookFRSafetyorEffectivenessDeterminationsList.pdf

lists products that have current and removed notices. The list is updated quarterly. Notices

issued during the year are added to the Electronic Orange Book Query in the month they become

effective.

The report is sorted by Active Ingredient(s), Dosage Form;Route, Trade Name, Firm Name and

Potency. Included are Type (Rx, OTC, Discn), Application Number, Product Number, Federal Register

Notice Date and Yes/No denoting whether the Footnote is currently in the Annual Edition Orange

Book or has been added to the Electronic Orange Book Query since the last edition was published.

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