APPROVED

DRUG

PRODUCTS

WITH

THERAPEUTIC

EQUIVALENCE

EVALUATIONS

32nd 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 PHARMACEUTICAL SCIENCE

OFFICE OF GENERIC DRUGS

2012

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, 2011.

32nd EDITION

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PHARMACEUTICAL SCIENCE

OFFICE OF GENERIC DRUGS

2012

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH
APPROVED DRUG PRODUCTS
with
Therapeutic Equivalence Evaluations

CONTENTS
PAGE

PREFACE TO THIRTY SECOND EDITION

2
2.1
2.2
2.3

..................iv

HOW TO USE THE DRUG PRODUCTS LISTS ..............................................................2-1

Key Sections for Using the Drug Product Lists ........2-1

Drug Product Illustration ......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

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

Drug Products Which Must Demonstrate in vivo Bioavailability

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

iii

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

APPROVED DRUG PRODUCTS

with

Therapeutic Equivalence Evaluations

PREFACE TO THIRTY SECOND EDITION

The publication, Approved Drug Products with Therapeutic Equivalence
Evaluations (the List, commonly known as the Orange Book), identifies drug
products approved on the basis of safety and effectiveness by the Food and
Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the
Act). Drugs on the market approved only on the basis of safety (covered by
the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal
Tablets and Librax Capsules] or pre-1938 drugs [e.g., Phenobarbital
Tablets]) are not included in this publication. The main criterion for the
inclusion of any product is that the product is the subject of an application
with an effective approval that has not been withdrawn for safety or efficacy
reasons. Inclusion of products on the List is independent of any current
regulatory action through administrative or judicial means against a drug
product. In addition, the List contains therapeutic equivalence evaluations
for approved multisource prescription drug products. These evaluations have
been prepared to serve as public information and advice to state health
agencies, prescribers, and pharmacists to promote public education in the area
of drug product selection and to foster containment of health care costs.
Therapeutic equivalence evaluations in this publication are not official FDA
actions affecting the legal status of products under the Act.
Background of the Publication. To contain drug costs, virtually every
state has adopted laws and/or regulations that encourage the substitution of
drug products. These state laws generally require either that substitution be
limited to drugs on a specific list (the positive formulary approach) or that
it be permitted for all drugs except those prohibited by a particular list
(the negative formulary approach). Because of the number of requests in the
late 1970s for FDA assistance in preparing both positive and negative
formularies, it became apparent that FDA could not serve the needs of each
state on an individual basis. The Agency also recognized that providing a
single list based on common criteria would be preferable to evaluating drug
products on the basis of differing definitions and criteria in various state
laws. As a result, on May 31, 1978, the Commissioner of the Food and Drug
Administration sent a letter to officials of each state stating FDA's intent
to provide a list of all prescription drug products that are approved by FDA
for safety and effectiveness, along with therapeutic equivalence
determinations for multisource prescription products.
The List was distributed as a proposal in January l979. It included only
currently marketed prescription drug products approved by FDA through new drug
applications (NDAs) and abbreviated new drug applications (ANDAs) under the
provisions of Section 505 of the Act.
The therapeutic equivalence evaluations in the List reflect FDA's
application of specific criteria to the multisource prescription drug products
on the List approved under Section 505 of the Act. These evaluations are
presented in the form of code letters that indicate the basis for the
evaluation made. An explanation of the code appears in the Introduction.
A complete discussion of the background and basis of FDA's therapeutic
equivalence evaluation policy was published in the Federal Register on
January 12, 1979 (44 FR 2932). The final rule, which includes FDA's responses
to the public comments on the proposal, was published in the Federal Register

iv

on October 31, 1980 (45 FR 72582). The first publication, October 1980, of
the final version of the List incorporated appropriate corrections and
additions. Each subsequent edition has included the new approvals and made
appropriate changes in data.
On September 24, 1984, the President signed into law the Drug Price
Competition and Patent Term Restoration Act (1984 Amendments). The 1984
Amendments require that FDA, among other things, make publicly available a
list of approved drug products with monthly supplements. The Approved Drug
Products with Therapeutic Equivalence Evaluations publication and its monthly
Cumulative Supplements satisfy this requirement. The Addendum to this
publication identifies drugs that qualify under the 1984 Amendments for
periods of exclusivity (during which ANDAs or applications described in
Section 505(b)(2) of the Act for those drugs may not be submitted for a
specified period of time and, if allowed to be submitted, would be tentatively
approved) and provides patent information concerning the listed drugs which
also may delay the approval of ANDAs or Section 505(b)(2) applications. The
Addendum also provides additional information that may be helpful to those
submitting a new drug application to the Agency.
The Agency intends to use this publication to further its objective of
obtaining input and comment on the publication itself and related Agency
procedures. Therefore, if you have comments on how the publication can be
improved, please send them to the Director, Division of Labeling and Program
Support, HFD-610, Office of Generic Drugs, Center for Drug and Evaluation and
Research, 7620 Standish Place, Rockville, MD 20855. Comments received are
publicly available to the extent allowable under the Freedom of Information
regulations.

1. INTRODUCTION

1.1 Content and Exclusion

The List is composed of four parts: (1) approved prescription drug
products with therapeutic equivalence evaluations; (2) approved
over-the-counter (OTC) drug products for those drugs that may not be marketed
without NDAs or ANDAs because they are not covered under existing OTC
monographs; (3) drug products with approval under Section 505 of the Act
administered by the Center for Biologics Evaluation and Research; and (4) a
cumulative list of approved products that have never been marketed, are for
exportation, are for military use, have been discontinued from marketing, or
have had their approvals withdrawn for other than safety or efficacy reasons
subsequent to being discontinued from marketing. 1 This publication also
includes indices of prescription and OTC drug products by trade or established
name (if no trade name exists) and by applicant name (holder of the approved
application). All established names for active ingredients generally conform
to official compendial names or United States Adopted Names (USAN) as
prescribed in (21 CFR 299.4(e)). The latter list includes applicants names
as abbreviated in this publication; in addition, a list of uniform terms is
provided.
An Addendum contains drug patent and exclusivity information for the
Prescription, OTC, Discontinued Drug Product Lists, and for the Drug Products
with Approval under Section 505 of the Act Administered by the Center for
Biologics Evaluation and Research. The publication may include additional
information that the Agency deems appropriate to disseminate.
Prior to the 6th Edition, the publication had excluded OTC drug products
and drug products with approval under Section 505 of the Act administered by
the Center for Biologics Evaluation and Research because the main purpose of
the publication was to provide information to states regarding FDA's
recommendation as to which generic prescription drug products were acceptable
candidates for drug product selection. The 1984 Amendments required the
Agency to begin publishing an up-to-date list of all marketed drug products,
OTC as well as prescription, that have been approved for safety and efficacy
and for which new drug applications are required.
Under the 1984 Amendments, some drug products are given tentative
approvals. The Agency will not include drug products with tentative approval
in the List. Tentative approval lists are available at ANDA (Generic) Drug
Approvals. When the tentative approval becomes a full approval through a
subsequent action letter to the application holder, the Agency will list the
drug product and the final approval date in the appropriate approved drug
product list.
Distributors or repackagers of products on the List are not identified.
Because distributors or repackagers are not required to notify FDA when they
shift their sources of supply from one approved manufacturer to another, it is
not possible to maintain complete information linking product approval with
the distributor or repackager handling the products.
1.2 Therapeutic Equivalence-Related Terms
Pharmaceutical Equivalents. Drug products are considered pharmaceutical
equivalents if they contain the same active ingredient(s), are of the same
1
Newly approved products are added to parts 1, 2, or 3, of the List, depending on the dispensing
requirements (prescription or OTC) or approval authority, unless the Orange Book staff is
otherwise notified before publication.

vi

dosage form, route of administration and are identical in strength or

concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules).
Pharmaceutically equivalent drug products are formulated to contain the same
amount of active ingredient in the same dosage form and to meet the same or
compendial or other applicable standards (i.e., strength, quality, purity, and
identity), but they may differ in characteristics such as shape, scoring
configuration, release mechanisms, packaging, excipients (including colors,
flavors, preservatives), expiration time, and, within certain limits,
labeling.
Pharmaceutical Alternatives. Drug products are considered pharmaceutical
alternatives if they contain the same therapeutic moiety, but are different
salts, esters, or complexes of that moiety, or are different dosage forms or
strengths (e.g., tetracycline hydrochloride, 250mg capsules vs. tetracycline
phosphate complex, 250mg capsules; quinidine sulfate, 200mg tablets vs.
quinidine sulfate, 200mg capsules). Data are generally not available for FDA
to make the determination of tablet to capsule bioequivalence. Different
dosage forms and strengths within a product line by a single manufacturer are
thus pharmaceutical alternatives, as are extended-release products when
compared with immediate-release or standard-release formulations of the same
active ingredient.
Therapeutic Equivalents. Drug products are considered to be therapeutic
equivalents only if they are pharmaceutical equivalents and if they can be
expected to have the same clinical effect and safety profile when administered
to patients under the conditions specified in the labeling.
FDA classifies as therapeutically equivalent those products that meet the
following general criteria: (1) they are approved as safe and effective; (2)
they are pharmaceutical equivalents in that they (a) contain identical amounts
of the same active drug ingredient in the same dosage form and route of
administration, and (b) meet compendial or other applicable standards of
strength, quality, purity, and identity; (3) they are bioequivalent in that
(a) they do not present a known or potential bioequivalence problem, and they
meet an acceptable in vitro standard, or (b) if they do present such a known
or potential problem, they are shown to meet an appropriate bioequivalence
standard; (4) they are adequately labeled; (5) they are manufactured in
compliance with Current Good Manufacturing Practice regulations. 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 drug product in the List repackaged and/or distributed by other
than the application holder is considered to be therapeutically equivalent to
the application holder's drug product even if the application holder's drug
product is single source or coded as non-equivalent (e.g., BN). Also,
distributors or repackagers of an application holder's drug product are
considered to have the same code as the application holder. Therapeutic
equivalence determinations are not made for unapproved, off-label indications.
FDA considers drug products to be therapeutically equivalent if they meet
the criteria outlined above, even though they may differ in certain other
characteristics such as shape, scoring configuration, release mechanisms,
packaging, excipients (including colors, flavors, preservatives), expiration
date/time and minor aspects of labeling (e.g., the presence of specific
pharmacokinetic information) and storage conditions. When such differences
are important in the care of a particular patient, it may be appropriate for
the prescribing physician to require that a particular brand be dispensed as a
medical necessity. With this limitation, however, FDA believes that products
classified as therapeutically equivalent can be substituted with the full
expectation that the substituted product will produce the same clinical effect
and safety profile as the prescribed product.
Bioavailability. This term means the rate and extent to which the active
ingredient or active moiety is absorbed from a drug product and becomes

vii

available at the site of action. For drug products that are not intended to
be absorbed into the bloodstream, bioavailability may be assessed by
measurements intended to reflect the rate and extent to which the active
ingredient or active moiety becomes available at the site of action.
Bioequivalent Drug Products. This term describes pharmaceutical equivalent
or pharmaceutical alternative products that display comparable bioavailability
when studied under similar experimental conditions. Section 505 (j)(8)(B) of
the Act describes one set of conditions under which a test and reference
listed drug (see Section 1.4) shall be considered bioequivalent:
the rate and extent of absorption of the test drug do not show a
significant difference from the rate and extent of absorption of the
reference drug when administered at the same molar dose of the
therapeutic ingredient under similar experimental conditions in either
a single dose or multiple doses; or
the extent of absorption of the test drug does not show a significant
difference from the extent of absorption of the reference drug when
administered at the same molar dose of the therapeutic ingredient under
similar experimental conditions in either a single dose or multiple
doses and the difference from the reference drug in the rate of
absorption of the drug is intentional, is reflected in its proposed
labeling, is not essential to the attainment of effective body drug
concentrations on chronic use, and is considered medically
insignificant for the drug.
Where these above methods are not applicable (e.g., for drug products that
are not intended to be absorbed into the bloodstream), other in vivo or in
vitro test methods to demonstrate bioequivalence may be appropriate.
Bioequivalence may sometimes be demonstrated using an in vitro
bioequivalence standard, especially when such an in vitro test has been
correlated with human in vivo bioavailability data. In other situations,
bioequivalence may sometimes be demonstrated through comparative clinical
trials or pharmacodynamic studies.
1.3 Statistical Criteria for Bioequivalence
Under the Drug Price Competition and Patent Term Restoration Act of 1984,
manufacturers seeking approval to market a generic drug product must submit
data demonstrating that the drug product is bioequivalent to the pioneer
(innovator) drug product. A major premise underlying the 1984 law is that
bioequivalent drug products are therapeutically equivalent, and therefore,
interchangeable.
Bioavailability refers to the rate and extent to which the active
ingredient or therapeutic ingredient is absorbed from a drug product and
becomes available at the site of drug action (Federal Food, Drug and Cosmetic
Act, section 505(j)(8)). Bioequivalence refers to equivalent release of the
same drug substance from two or more drug products or formulations. This
leads to an equivalent rate and extent of absorption from these formulations.
Underlying the concept of bioequivalence is the thesis that, if a drug product
contains a drug substance that is chemically identical and is delivered to the
site of action at the same rate and extent as another drug product, then it is
equivalent and can be substituted for that drug product. Methods used to
define bioequivalence can be found in 21 CFR 320.24, and include (1)
pharmacokinetic (PK) studies, (2) pharmacodynamic (PD) studies, (3)
comparative clinical trials, and (4) in-vitro studies. The choice of study
used is based on the site of action of the drug and the ability of the study
design to compare drug delivered to that site by the two products.
The standard bioequivalence (PK) study is conducted using a two-treatment
crossover study design in a limited number of volunteers, usually 24 to 36

viii

adults. Alternately, a four-period, replicate design crossover study may also

be used.
Single doses of the test and reference drug products are
administered and blood or plasma levels of the drug are measured over time.
Pharmacokinetic parameters characterizing rate and extent of drug absorption
are evaluated statistically. The PK parameters of interest are the resulting
area under the plasma concentration-time curve (AUC), calculated to the last
measured concentration (AUC(0-t)) and extrapolated to infinity (AUC(0-inf)), for
extent of absorption; and the maximum or peak drug concentrations (Cmax), for
rate of absorption. Crossover studies may not be practical in drugs with a
long half-life in the body, and a parallel study design may be used instead.
Alternate study methods, such as in-vitro studies or equivalence studies with
clinical or pharmacodynamic endpoints, are used for drug products where plasma
concentrations are not useful to determine delivery of the drug substance to
the site of activity (such as inhalers, nasal sprays and topical products
applied to the skin).
The statistical methodology for analyzing these bioequivalence studies is
called the two one-sided test procedure. Two situations are tested with this
statistical methodology. The first of the two one-sided tests determines
whether a generic product (test), when substituted for a brand-name product
(reference) is significantly less bioavailable. The second of the two onesided tests determines whether a brand-name product when substituted for a
generic product is significantly less bioavailable. Based on the opinions of
FDA medical experts, a difference of greater than 20% for each of the above
tests was determined to be significant, and therefore, undesirable for all
drug products. Numerically, this is expressed as a limit of test-product
average/reference-product average of 80% for the first statistical test and a
limit of reference-product average/test-product average of 80% for the second
statistical test. By convention, all data is expressed as a ratio of the
average response (AUC and Cmax) for test/reference, so the limit expressed in
the second statistical test is 125% (reciprocal of 80%).
For statistical reasons, all data is log-transformed prior to conducting
statistical testing. In practice, these statistical tests are carried out
using an analysis of variance procedure (ANOVA) and calculating a 90%
confidence interval for each pharmacokinetic parameter (Cmax and AUC). The
confidence interval for both pharmacokinetic parameters, AUC and Cmax, must be
entirely within the 80% to 125% boundaries cited above. Because the mean of
the study data lies in the center of the 90% confidence interval, the mean of
the data is usually close to 100% (a test/reference ratio of 1). Different
statistical criteria are sometimes used when bioequivalence is demonstrated
through comparative clinical trials pharmacodynamic studies, or comparative
in-vitro methodology.
The bioequivalence methodology and criteria described above simultaneously
control for both differences in the average response between test and
reference, as well as the precision with which the average response in the
population is estimated. This precision depends on the within-subject (normal
volunteer or patient) variability in the pharmacokinetic parameters (AUC and
Cmax) of the two products and on the number of subjects in the study. The
width of the 90% confidence interval is a reflection in part of the withinsubject variability of the test and reference products in the bioequivalence
study. A test product with no differences in the average response when
compared to the reference might still fail to pass the bioequivalence criteria
if the variability of one or both products is high and the bioequivalence
study has insufficient statistical power (i.e., insufficient number of
subjects). Likewise, a test product with low variability may pass the
bioequivalence criteria, when there are somewhat larger differences in the
average response.
This system of assessing bioequivalence of generic products assures that
these substitutable products do not deviate substantially in in-vivo
performance from the reference product. The Office of Generic Drugs has
conducted two surveys to quantify the differences between generic and brand
name products. The first survey included 224 bioequivalence studies submitted

ix

in approved applications during 1985 and 1986. The observed average

differences between reference and generic products for AUC was 3.5% (JAMA,
Sept. 4, 1987, Vol. 258, No. 9). The second survey included 127
bioequivalence studies submitted to the agency in 273 ANDAs approved in 1997.
The three measures reviewed include AUC(0-t), AUC(0-inf), and Cmax. The observed
average differences between the reference and generic products were + 3.47%
(SD 2.84) for AUC(0-t), + 3.25% (SD 2.97) for AUC(0-inf), and + 4.29% (SD 3.72)
for Cmax (JAMA, Dec. 1, 1999, Vol. 282, No. 21).
The primary concern from the regulatory point of view is the protection of
the patient against approval of products that are not bioequivalent. The
current practice of carrying out two one-sided tests at the 0.05 level of
significance ensures that there is no more than a 5% chance that a generic
product that is not truly equivalent to the reference will be approved.
1.4 Reference Listed Drug
A reference listed drug (21 CFR 314.94(a)(3)) means the listed drug
identified by FDA as the drug product upon which an applicant relies in
seeking approval of its ANDA.
FDA has identified in the Prescription Drug Product and OTC Drug Product
Lists those reference listed drugs to which the in vivo bioequivalence
(reference standard) and, in some instances, the in vitro bioequivalence of
the applicant's product is compared. By designating a single reference listed
drug as the standard to which all generic versions must be shown to be
bioequivalent, FDA hopes to avoid possible significant variations among
generic drugs and their brand name counterpart. Such variations could result
if generic drugs were compared to different reference listed drugs. However,
in some instances when listed drugs are approved for a single drug product, a
product not designated as the reference listed drug and not shown to be
bioequivalent to the reference listed drug may be shielded from generic
competition. A firm wishing to market a generic version of a listed drug that
is not designated as the reference listed drug may petition the Agency through
the Citizen Petition procedure (see 21 CFR 10.25(a) and CFR 10.30). When the
Citizen Petition is approved, the second listed drug will be designated as an
additional reference listed drug and the petitioner may submit an Abbreviated
New Drug Application citing the designated reference listed drug. Section
1.7, Therapeutic Equivalence Evaluations Codes products meeting necessary
bioequivalence requirements explains the (AB, AB1, AB2, AB3... coding system
for multisource drug products listed under the same heading with two reference
listed drugs.
In addition, there are two situations in which two listed drugs that have
been shown to be bioequivalent to each other may both be designated as
reference listed drugs. The first situation occurs when the in vivo
determination of bioequivalence is self-evident and a waiver of the in vivo
bioequivalence may be granted. The second situation occurs when the
bioequivalence of two listed products may be determined through in vitro
methodology. The reference listed drug is identified by the symbol "+" in the
Prescription and Over-the-Counter (OTC) Drug Product Lists. These identified
reference listed drugs represent the best judgment of the Division of
Bioequivalence at this time. The Prescription and OTC Drug Product Lists
identify reference drugs for oral dosage forms, Injectables, ophthalmics,
otics, and topical products. It is recommended that a firm planning to
conduct an in vivo bioequivalence study, or planning to manufacture a batch of
a drug product for which an in vivo waiver of bioequivalence will be
requested, contact the Division of Bioequivalence, Office of Generic Drugs, to
confirm the appropriate reference listed drug.

1.5 General Policies and Legal Status

The List contains public information and advice. It does not mandate the
drug products which is purchased, prescribed, dispensed, or substituted for
one another, nor does it, conversely, mandate the products that should be
avoided. To the extent that the List sets forth FDA's evaluations of the
therapeutic equivalence of drug products that have been approved, it contains
FDA's advice to the public, to practitioners and to the states regarding drug
product selection. These evaluations do not constitute determinations that
any product is in violation of the Act or that any product is preferable to
any other. Therapeutic equivalence evaluations are a scientific judgment
based upon evidence, while generic substitution may involve social and
economic policy administered by the states, intended to reduce the cost of
drugs to consumers. To the extent that the List identifies drug products
approved under Section 505 of the Act, it sets forth information that the
Agency is required to publish and that the public is entitled to under the
Freedom of Information Act. Exclusion of a drug product from the List does
not necessarily mean that the drug product is either in violation of Section
505 of the Act, or that such a product is not safe or effective, or that such
a product is not therapeutically equivalent to other drug products. Rather,
the exclusion is based on the fact that FDA has not evaluated the safety,
effectiveness, and quality of the drug product.
1.6

Practitioner/User Responsibilities

Professional care and judgment should be exercised in using the List.

Evaluations of therapeutic equivalence for prescription drugs are based on
scientific and medical evaluations by FDA. Products evaluated as
therapeutically equivalent can be expected, in the judgment of FDA, to have
equivalent clinical effect and no difference in their potential for adverse
effects when used under the conditions of their labeling. However, these
products may differ in other characteristics such as shape, scoring
configuration, release mechanisms, packaging, excipients (including colors,
flavors, preservatives), expiration date/time, and, in some instances,
labeling. If products with such differences are substituted for each other,
there is a potential for patient confusion due to differences in color or
shape of tablets, inability to provide a given dose using a partial tablet if
the proper scoring configuration is not available, or decreased patient
acceptance of certain products because of flavor. There may also be better
stability of one product over another under adverse storage conditions, or
allergic reactions in rare cases due to a coloring or a preservative
ingredient, as well as differences in cost to the patient.
FDA evaluation of therapeutic equivalence in no way relieves practitioners
of their professional responsibilities in prescribing and dispensing such
products with due care and with appropriate information to individual
patients. In those circumstances where the characteristics of a specific
product, other than its active ingredient, are important in the therapy of a
particular patient, the physician's specification of that product is
appropriate. Pharmacists must also be familiar with the expiration
dates/times and labeling directions for storage of the different products,
particularly for reconstituted products, to assure that patients are properly
advised when one product is substituted for another.
Multisource and single-source drug products. FDA has evaluated for
therapeutic equivalence only multisource prescription drug products approved
under Section 505 of the Act, which in most instances means those
pharmaceutical equivalents available from more than one manufacturer. For
such products, a therapeutic equivalence code is included and, in addition,
product information is highlighted in bold face and underlined. Those
products with approved applications that are single-source (i.e., there is
only one approved product available for that active ingredient, dosage form,
route of administration, and strength) are also included on the List, but no
therapeutic equivalence code is included with such products. Any drug product

xi

in the List repackaged and/or distributed by other than the application holder
is considered to be therapeutically equivalent to the application holder's
drug product even if the application holder's drug product is single source or
coded as non-equivalent (e.g., BN). Also, although not identified in the
List, distributors or repackagers of an application holder's drug product are
considered to have the same code as the application holder. The details of
these codes and the policies underlying them are discussed in Section 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 applicant may have had its product manufactured by a
contract manufacturer and may simply be distributing the product for which it
has obtained approval. In most instances, however, the manufacturer of the
product is also the applicant. The name of the manufacturer is permitted by
regulation to appear on the label, even when the manufacturer is not the
marketer.
Although the products on the List are identified by the names of the
applicants, circumstances, such as changing corporate ownership, have
sometimes made identification of the applicant difficult. The Agency
believes, based on continuing document review and communication with firms,
that the applicant designations on the List are, in most cases, correct.
To relate firm name information on a product label to that on the List,
the following should be noted: the applicant's name always appears on the
List. This applies whether the applicant (firm name on the Form FDA 356h in
the application) is the marketer (firm name in largest letters on the label)
or not. However, the applicant's name may not always appear on the label of
the product.
If the applicant is the marketer, its name appears on the List and on the
label; if the applicant is not the marketer, and the Agency is aware of a
corporate relationship (e.g., parent and subsidiary) between the applicant and
the marketer, the name of the applicant appears on the List and both firm
names may appear on the label. Firms with known corporate relationships are
displayed in Appendix B. If there is no known corporate relationship between
the applicant and the marketer, the applicant's name appears on the List;
however, unless the applicant is the manufacturer, packager, or distributor,
the applicant's name may not appear on the label. In this case, the
practitioner, from labeling alone, will not be able to relate the marketed
product to an applicant cited in the List, and hence to a specific approved
drug product. In such cases, to assure that the product in question is the
subject of an approved application, the firm named on the label should be
contacted.
To relate trade name (proprietary name) information on a product label to
that on the List, the following should be noted: if the applicant is the
marketer, its name appears on the List and on the label; if the Agency is
aware of a corporate relationship between the applicant and the marketer, the
trade name (proprietary name) of the drug product (established drug name if no
trade name exists) appears on the List. If a corporate relationship exists
between an application holder and a marketer and both firms are distributing
the drug product, the FDA reserves the right to select the trade name of
either the marketer or the application holder to appear on the List. If there
is no known corporate relationship between the applicant and the marketer, the
established drug name appears on the List.
Every product on the List is subject at all times to regulatory action.
From time to time, approved products may be found in violation of one or more
provisions of the Act. In such circumstances, the Agency will commence
appropriate enforcement action to correct the violation, if necessary, by
securing removal of the product from the market by voluntary recall, seizure,
or other enforcement actions. Such regulatory actions are, however,
independent of the inclusion of a product on the List. The main criterion for

xii

inclusion of a product is that it has an application with an effective

approval that has not been withdrawn for safety or efficacy reasons. FDA
believes that retention of a violative product on the List will not have any
significant adverse health consequences, because other legal mechanisms are
available to the Agency to prevent the product's actual marketing. FDA may
however, change a product's therapeutic equivalence rating if the
circumstances giving rise to the violation change or otherwise call into
question the data upon which the Agency's assessment of whether a product
meets the criteria for therapeutic equivalence was made.

1.7 Therapeutic Equivalence Evaluations Codes

The coding system for therapeutic equivalence evaluations is constructed
to allow users to determine quickly whether the Agency has evaluated a
particular approved product as therapeutically equivalent to other
pharmaceutically equivalent products (first letter) and to provide additional
information on the basis of FDA's evaluations (second letter). With few
exceptions, the therapeutic equivalence evaluation date is the same as the
approval date.
The two basic categories into which multisource drugs have been placed are
indicated by the first letter as follows:
A Drug products that FDA considers to be therapeutically equivalent to
other pharmaceutically equivalent products, i.e., drug products for which:
(1) there are no known or suspected bioequivalence problems. These are
designated AA, AN, AO, AP, or AT, depending on the dosage form; or
(2) actual or potential bioequivalence problems have been resolved with
adequate in vivo and/or in vitro evidence supporting
bioequivalence. These are designated AB.
B Drug products that FDA at this time, considers not to be
therapeutically equivalent to other pharmaceutically equivalent products,
i.e.,
drug products for which actual or potential bioequivalence problems
have not been resolved by adequate evidence of bioequivalence. Often
the problem is with specific dosage forms rather than with the active
ingredients. These are designated BC, BD, BE, BN, BP, BR, BS, BT, BX,
or B*.
Individual drug products have been evaluated as therapeutically equivalent
to the reference product in accordance with the definitions and policies
outlined below:
"A" CODES
Drug products that are considered to be therapeutically equivalent to other pharmaceutically
equivalent products.
"A" products are those for which actual or potential bioequivalence
problems have been resolved with adequate in vivo and/or in vitro evidence
supporting bio-equivalence. Drug products designated with an "A" code fall
under one of two main policies:
(1) for those active ingredients or dosage forms for which no in vivo
bioequivalence issue is known or suspected, the information necessary to
show bioequivalence between pharmaceutically equivalent products is
presumed and considered self-evident based on other data in the
application for some dosage forms (e.g., solutions) or satisfied for

xiii

solid oral dosage forms by a showing that an acceptable in vitro

dissolution standard is met. A therapeutically equivalent rating is
assigned such products so long as they are manufactured in accordance
with Current Good Manufacturing Practice regulations and meet the other
requirements of their approved applications (these are designated AA, AN,
AO, AP, or AT, depending on the dosage form, as described below); or
(2) for those DESI drug products containing active ingredients or dosage

forms that have been identified by FDA as having actual or potential

bioequivalence problems, and for post-1962 drug products in a dosage

form presenting a potential bioequivalence problem, an evaluation of

therapeutic equivalence is assigned to pharmaceutical equivalents only

if the approved application contains adequate scientific evidence

establishing through in vivo and/or in vitro studies the bioequivalence

of the product to a selected reference product (these products are

designated as AB).

There are some general principles that may affect the substitution of
pharmaceutically equivalent products in specific cases. Prescribers and
dispensers of drugs should be alert to these principles so as to deal
appropriately with situations that require professional judgment and
discretion.
There may be labeling differences among pharmaceutically equivalent
products that require attention on the part of the health professional. For
example, pharmaceutically equivalent powders to be reconstituted for
administration as oral or injectable liquids may vary with respect to their
expiration time or storage conditions after reconstitution. An FDA evaluation
that such products are therapeutically equivalent is applicable only when each
product is reconstituted, stored, and used under the conditions specified in
the labeling of that product.
The Agency will use notes in this publication to point out special
situations such as potential differences between two drug products that have
been evaluated as bioequivalent and otherwise therapeutically equivalent, when
they should be brought to the attention of health professionals. These notes
are contained in Section 1.8, Description of Special Situations.
For example, in rare instances, there may be variations among
therapeutically equivalent products in their use or in conditions of
administration. Such differences may be due to patent or exclusivity rights
associated with such use. When such variations may, in the Agency's opinion,
affect prescribing or substitution decisions by health professionals, a note
will be added to Section 1.8.
Also, occasionally a situation may arise in which changes in a listed drug
product after its approval (for example, a change in dosing interval) may have
an impact on the substitutability of already approved generic versions of that
product that were rated by the Agency as therapeutically equivalent to the
listed product. When such changes in the listed drug product are considered
by the Agency to have a significant impact on therapeutic equivalence, the
Agency will change the therapeutic equivalence ratings for other versions of
the drug product unless the manufacturers of those other versions of the
product provide additional information to assure equivalence under the changed
conditions. Pending receipt of the additional data, the Agency may add a note
to Section 1.8, or, in rare cases, may even change the therapeutic equivalence
rating.
In some cases (e.g., Isolyte S w/ Dextrose 5% in Plastic Container and
Plasma-Lyte 148 and Dextrose 5% in Plastic Container), closely related
products are listed as containing the same active ingredients, but in somewhat
different amounts. In determining which of these products are
pharmaceutically equivalent, the Agency has considered products to be
pharmaceutically equivalent with labeled strengths of an ingredient that do
not vary by more than 1%.

xiv

Different salts and esters of the same therapeutic moiety are regarded as
pharmaceutical alternatives. For the purpose of this publication, such
products are not considered to be therapeutically equivalent. There are no
instances in this List where pharmaceutical alternatives are evaluated or
coded with regard to therapeutic equivalence. Anhydrous and hydrated entities,
as well as different polymorphs, are considered pharmaceutical equivalents and
must meet the same standards and, where necessary, as in the case of
ampicillin/ampicillin trihydrate, their equivalence is supported by
appropriate bioavailability/bioequivalence studies.
The codes in this book are not intended to preclude health care
professionals from converting pharmaceutically different concentrations into
pharmaceutical equivalents using accepted professional practice.
Where package size variations have therapeutic implications, products so
packaged have not been considered pharmaceutically equivalent. For example,
some oral contraceptives are supplied in 21-tablet and 28-tablet packets; the
28-tablet packets contain 7 placebo or iron tablets. These two packaging
configurations are not regarded as pharmaceutically equivalent; thus, they are
not designated as therapeutically equivalent.
Preservatives may differ among some therapeutically equivalent drug
products. Differences in preservatives and other inactive ingredients do not
affect FDA's evaluation of therapeutic equivalence except in cases where these
components may influence bioequivalence or routes of administration.
The specific sub-codes for those drugs evaluated as therapeutically
equivalent and the policies underlying these sub-codes follow:
AA Products in conventional dosage forms not presenting bioequivalence problems
Products coded as AA contain active ingredients and dosage forms that are
not regarded as presenting either actual or potential bioequivalence
problems or drug quality or standards issues. However, all oral dosage
forms must, nonetheless, meet an appropriate in vitro bioequivalence
standard that is acceptable to the Agency in order to be approved.
AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements
Multisource drug products listed under the same heading (i.e., identical
active ingredients(s), dosage form, and route(s) of administration) and
having the same strength (see Section 1.2, Therapeutic Equivalence-Related
Terms, Pharmaceutical Equivalents) generally will be coded AB if a study
is submitted demonstrating bioequivalence.
In certain instances, a number is added to the end of the AB code to make
a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes
are assigned only in situations when more than one reference listed drug
of the same strength has been designated under the same heading. Two or
more reference listed drugs are generally selected only when there are at
least two potential reference drug products which are not bioequivalent to
each other. If a study is submitted that demonstrates bioequivalence to a
specific listed drug product, the generic product will be given the same
three-character code as the reference listed drug it was compared against.
For example, Adalat CC (Miles) and Procardia XL (Pfizer), extendedrelease tablets, are listed under the active ingredient nifedipine. These
drug products, listed under the same heading, are not bioequivalent to
each other. Generic drug products deemed by FDA to be bioequivalent to
Adalat CC and Procardia XL have been approved, Adalat CC and Procardia
XL have been assigned ratings of AB1 and AB2, respectively. The generic
drug products bioequivalent to Adalat CC would be assigned a rating of
AB1 and those bioequivalent to Procardia XL would be assigned a rating of

xv

AB2. (The assignment of an AB1 or AB2 rating to a specific product does

not imply product preference.) Even though drug products of distributors
and/or repackagers are not included in the List, they are considered
therapeutically equivalent to the application holder's drug product if the
application holder's drug product is rated either with an AB or threecharacter code or is single source in the List. Drugs coded as AB under a
heading are considered therapeutically equivalent only to other drugs
coded as AB under that heading. Drugs coded with a three-character code
under a heading are considered therapeutically equivalent only to other
drugs coded with the same three-character code under that heading.
AN Solutions and powders for aerosolization
Uncertainty regarding the therapeutic equivalence of aerosolized products
arises primarily because of differences in the drug delivery system.
Solutions and powders intended for aerosolization that are marketed for
use in any of several delivery systems are considered to be
pharmaceutically and therapeutically equivalent and are coded AN. Those
products that are compatible only with a specific delivery system or those
products that are packaged in and with a specific delivery system are
coded BN, unless they have met an appropriate bioequivalence standard.
Solutions or suspensions in a specific delivery system will be coded AN if
the bioequivalence standard is based upon in vitro methodology, if
bioequivalence needs to be demonstrated by in vivo methodology then the
drug products will be coded AB.

AO Injectable oil solutions

The absorption of drugs in injectable (parenteral) oil solutions may vary
substantially with the type of oil employed as a vehicle and the
concentration of the active ingredient. Injectable oil solutions are
therefore considered to be pharmaceutically and therapeutically equivalent
only when the active ingredient, its concentration, and the type of oil
used as a vehicle are all identical.

AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous

solutions
It should be noted that even though injectable (parenteral) products under
a specific listing may be evaluated as therapeutically equivalent, there
may be important differences among the products in the general category,
Injectable; Injection. For example, some injectable products that are
rated therapeutically equivalent are labeled for different routes of
administration. In addition, some products evaluated as therapeutically
equivalent may have different preservatives or no preservatives at all.
Injectable products available as dry powders for reconstitution,
concentrated sterile solutions for dilution, or sterile solutions ready
for injection are pharmaceutical alternative drug products. They are not
rated as therapeutically equivalent (AP) to each other even if these
pharmaceutical alternative drug products are designed to produce the same
concentration prior to injection and are similarly labeled.
Consistent
with accepted professional practice, it is the responsibility of the
prescriber, dispenser, or individual administering the product to be
familiar with a product's labeling to assure that it is given only by the
route(s) of administration stated in the labeling.
Certain commonly used large volume intravenous products
containers are not included on the List (e.g., dextrose
dextrose injection 10%, sodium chloride injection 0.9%)
products are on the market without FDA approval and the

xvi

in glass
injection 5%,
since these
FDA has not

published conditions for marketing such parenteral products under approved

NDAs. When packaged in plastic containers, however, FDA regulations
require approved applications prior to marketing. Approval then depends
on, among other things, the extent of the available safety data involving
the specific plastic component of the product. All large volume
parenteral products are manufactured under similar standards, regardless
of whether they are packaged in glass or plastic. Thus, FDA has no reason
to believe that the packaging container of large volume parenteral drug
products that are pharmaceutically equivalent would have any effect on
their therapeutic equivalence.
The strength of parenteral drugs products is defined as the total drug
content of the container. Until recently the strength of liquid
parenteral drug products in the Orange Book have not been displayed. The
concentration of the liquid parenteral drug product in the Orange Book has
been shown as xmg/ml. The amount of dry powder or freeze dried powder in
a container has always been identified as the strength.
With the finalization of the Waxman-Hatch amendments that characterized
each strength of a drug product as a listed drug, it became evident that
the format of the Orange Book should be changed to reflect each strength
of a parenteral solution. To this end the OGD has started to display the
strength of all new approvals of parenteral solutions. Previously we
would have displayed only the concentration of an approved parenteral
solution, e.g. 50mg/ml. If this drug product had a 20 ml and 60 ml
container approved the two products would be shown as 1Gm / 20ml (50mg/ml)
and 3Gm / 60ml (50mg/ml).

AT Topical products
There are a variety of topical dosage forms available for dermatologic,
ophthalmic, otic, rectal, and vaginal administration, including creams,
gels, lotions, oils, ointments, pastes, solutions, sprays and
suppositories. Even though different topical dosage forms may contain the
same active ingredient and potency, these dosage forms are not considered
pharmaceutically equivalent. Therefore, they are not considered
therapeutically equivalent. All solutions and DESI drug products
containing the same active ingredient in the same topical dosage form for
which a waiver of in vivo bioequivalence has been granted and for which
chemistry and manufacturing processes are adequate to demonstrate
bioequivalence, are considered therapeutically equivalent and coded AT.
Pharmaceutically equivalent topical products that raise questions of
bioequivalence, including all post-1962 non-solution topical drug
products, are coded AB when supported by adequate bioequivalence data, and
BT in the absence of such data.

"B" CODES
Drug products that FDA, at this time, considers not to be therapeutically equivalent to other
pharmaceutically equivalent products.
"B" products, for which actual or potential bioequivalence problems have
not been resolved by adequate evidence of bioequivalence, often have a problem
with specific dosage forms rather than with the active ingredients. Drug
products designated with a "B" code fall under one of three main policies:
(1)

the drug products contain active ingredients or are manufactured in

dosage forms that have been identified by the Agency as having
documented bio-equivalence problems or a significant potential for
such problems and for which no adequate studies demonstrating
bioequivalence have been submitted to FDA; or

xvii

(2)

the quality standards are inadequate or FDA has an insufficient basis

to determine therapeutic equivalence; or

(3)

the drug products are under regulatory review.

The specific coding definitions and policies for the "B" sub-codes are as
follows:

B* Drug products requiring further FDA investigation and review to determine therapeutic
equivalence
The code B* is assigned to products previously assigned an A or B code
when FDA receives new information that raises a significant question
regarding therapeutic equivalence that can be resolved only through
further Agency investigation and/or review of data and information
submitted by the applicant. The B* code signifies that the Agency will
take no position regarding the therapeutic equivalence of the product
until the Agency completes its investigation and review.
BC Extended-release dosage forms (capsules, injectables and tablets)
Extended-release tablets are formulated in such a manner as to make the
contained medicament available over an extended period of time following
ingestion.
Although bioavailability studies have been conducted on these dosage
forms, they may be subject to bioavailability differences, primarily
because firms developing extended-release products for the same active
ingredient rarely employ the same formulation approach. FDA, therefore,
does not consider different extended-release dosage forms containing the
same active ingredient in equal strength to be therapeutically equivalent
unless equivalence between individual products in both rate and extent has
been specifically demonstrated through appropriate bioequivalence studies.
Extended-release products for which such bioequivalence data have not been
submitted are coded BC, while those for which such data are available have
been coded AB.

BD Active ingredients and dosage forms with documented bioequivalence problems

The BD code denotes products containing active ingredients with known
bioequivalence problems and for which adequate studies have not been
submitted to FDA demonstrating bioequivalence. Where studies showing
bioequivalence have been submitted, the product has been coded AB.

BE Delayed-release oral dosage forms

Where the drug may be destroyed or inactivated by the gastric juice or
where it may irritate the gastric mucosa, the use of enteric coatings is
indicated. Such coatings are intended to delay the release of the
medication until the tablet has passed through the stomach. Drug products
in delayed-release dosage forms containing the same active ingredients are
subject to significant differences in absorption. Unless otherwise
specifically noted, the Agency considers different delayed-release
products containing the same active ingredients as presenting a potential
bioequivalence problem and codes these products BE in the absence of
in vivo studies showing bioequivalence. If adequate in vivo studies have
demonstrated the bioequivalence of specific delayed-release products, such
products are coded AB.

xviii

BN Products in aerosol-nebulizer drug delivery systems

This code applies to drug solutions or powders that are marketed only as a
component of, or as compatible with, a specific drug delivery system.
There may, for example, be significant differences in the dose of drug and
particle size delivered by different products of this type. Therefore,
the Agency does not consider different metered aerosol dosage forms
containing the same active ingredient(s) in equal strengths to be
therapeutically equivalent unless the drug products meet an appropriate
bioequivalence standard, such products are coded AB.

BP Active ingredients and dosage forms with potential bioequivalence problems

FDA's bioequivalence regulations (21 CFR 320.33) contain criteria and
procedures for determining whether a specific active ingredient in a
specific dosage form has a potential for causing a bioequivalence problem.
It is FDA's policy to consider an ingredient meeting these criteria as
having a potential bioequivalence problem even in the absence of positive
data demonstrating inequivalence. Pharmaceutically equivalent products
containing these ingredients in oral dosage forms are coded BP until
adequate in vivo bioequivalence data are submitted, such products are
coded AB. Injectable suspensions containing an active ingredient
suspended in an aqueous or oleaginous vehicle have also been coded BP.
Injectable suspensions are subject to bioequivalence problems because
differences in particle size, polymorphic structure of the suspended
active ingredient, or the suspension formulation can significantly affect
the rate of release and absorption. FDA does not consider pharmaceutical
equivalents of these products bioequivalent without adequate evidence of
bioequivalence, such products would be coded AB.

BR Suppositories or enemas that deliver drugs for systemic absorption

The absorption of active ingredients from suppositories or enemas that are
intended to have a systemic effect (as distinct from suppositories
administered for local effect) can vary significantly from product to
product. Therefore, FDA considers pharmaceutically equivalent systemic
suppositories or enemas bio-equivalent only if in vivo evidence of
bioequivalence is available. In those cases where in vivo evidence is
available, the product is coded AB. If such evidence is not available,
the products are coded BR.

BS Products having drug standard deficiencies

If the drug standards for an active ingredient in a particular dosage form
are found by FDA to be deficient so as to prevent an FDA evaluation of
either pharmaceutical or therapeutic equivalence, all drug products
containing that active ingredient in that dosage form are coded BS. For
example, if the standards permit a wide variation in pharmacologically
active components of the active ingredient such that pharmaceutical
equivalence is in question, all products containing that active ingredient
in that dosage form are coded BS.

xix

BT Topical products with bioequivalence issues

This code applies mainly to post-1962 dermatologic, ophthalmic, otic,
rectal, and vaginal products for topical administration, including creams,
ointments, gels, lotions, pastes, and sprays, as well as suppositories not
intended for systemic drug absorption. Topical products evaluated as
having acceptable clinical performance, but that are not bioequivalent to
other pharmaceutically equivalent products or that lack sufficient
evidence of bioequivalence, will be coded BT.

BX Drug products for which the data are insufficient to determine therapeutic equivalence
The code BX is assigned to specific drug products for which the data that
have been reviewed by the Agency are insufficient to determine therapeutic
equivalence under the policies stated in this document. In these
situations, the drug products are presumed to be therapeutically
inequivalent until the Agency has determined that there is adequate
information to make a full evaluation of therapeutic equivalence.

1.8 Description of Special Situations

Certain drugs listed in the Orange Book present special situations that
merit further discussion. Following is a description of those special
situations:
Amino Acid and Protein Hydrolysate Injections. These products differ in
the amount and kinds of amino acids they contain and, therefore, are not
considered pharmaceutical equivalents. For this reason, these products are
not considered therapeutically equivalent. At the same time, the Agency
believes that it is appropriate to point out that where nitrogen balance is
the sole therapeutic objective and individual amino acid content is not a
consideration, pharmaceutical alternatives with the same total amount of
nitrogen content may be considered therapeutically equivalent.
Follitropin Alfa and Beta. Based on available data derived from physico
chemical tests and bioassay, follitropin alfa and follitropin beta are
indistinguishable.
Gaviscon.
Gaviscon is an OTC product which has been marketed since
September 1970. The active ingredients in this product, aluminum hydroxide
and magnesium trisilicate, were reviewed by the Agency's OTC Antacid Panel and
were considered to be safe and effective ingredients (Category I) by that
Panel. However, the tablet failed to pass the antacid test which is required
of all antacid products. The Agency, therefore, placed the tablet in Category
III for lack of effectiveness. A full NDA with clinical studies was submitted
by Marion Laboratories, Inc., and approved by FDA on December 9, 1983.
Gaviscons activity in treating reflux acidity is made possible by the
physical-chemical properties of the inactive ingredients, sodium bicarbonate
and alginic acid. Therefore, all ANDAs which cite Gaviscon tablets as the
listed drug must contain the inactive ingredients sodium bicarbonate and
alginic acid. A full NDA will be required to support the effectiveness of the
drug product if different inactive ingredients are to be substituted for
sodium bicarbonate or alginic acid or if different proportions of these
ingredients are to be used.
Levothyroxine Sodium. Because there are multiple reference listed drugs
of levothyroxine sodium tablets and some reference listed drugs' sponsors have
conducted studies to establish their drugs' therapeutic equivalence to other
reference listed drugs, FDA has determined that its usual practice of
assigning two or three character TE codes may be potentially confusing and
inadequate for these drug products. Accordingly, FDA provides the following
explanation and chart of therapeutic equivalence evaluations for levothyroxine

xx

sodium drug products.

Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be
therapeutically equivalent to corresponding strengths of Unithroid (Jerome
Stevens NDA 021210) tablets.
Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187), Unithroid
(Jerome Stevens NDA 021210), and Levothyroxine Sodium (Merck KGAA ANDA
76752)tablets have been determined to be therapeutically equivalent to
corresponding strengths of Synthroid (Abbott NDA 021402) tablets.
Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210),
Levothyroxine Sodium (Mylan ANDA 076187), and Levothyroxine Sodium (Merck KGAA
ANDA 76752) tablets have been determined to be therapeutically equivalent to
corresponding strengths of Levoxyl (King Pharms NDA 021301) tablets.
Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be
therapeutically equivalent to corresponding strengths of Levothroid (Lloyd NDA
021116) tablets.
The chart outlines TE codes for all 0.025mg products. Other product strengths
may be similar. Therapeutic equivalence has been established between products
that have the same AB+number TE code. More than one TE code may apply to some
products. One common TE code indicates therapeutic equivalence between
products.
Trade Name

Applicant

Potency

TE
Code

Appl
No

Product
No

UNITHROID
LEVOTHYROXINE SODIUM
LEVOXYL
SYNTHROID
LEVO-T

STEVENS J
MYLAN
KING PHARMS
ABBOTT
ALARA PHARM

0.025MG
0.025MG
0.025MG
0.025MG
0.025MG

AB1
AB1
AB1
AB1
AB1

021210
076187
021301
021402
021342

001
001
001
001
001

SYNTHROID
LEVOTHYROXINE SODIUM
LEVO-T
UNITHROID
LEVOTHYROXINE SODIUM

ABBOTT
MYLAN
ALARA PHARM
STEVENS J
MERCK KGAA

0.025MG
0.025MG
0.025MG
0.025MG
0.025MG

AB2
AB2
AB2
AB2
AB2

021402
076187
021342
021210
076752

001
001
001
001
001

LEVOXYL
LEVO-T
UNITHROID
LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM

KING PHARMS
ALARA PHARM
STEVENS J
MYLAN
MERCK KGAA

0.025MG
0.025MG
0.025MG
0.025MG
0.025MG

AB3
AB3
AB3
AB3
AB3

021301
021342
021210
076187
076752

001
001
001
001
001

LEVOTHROID
LEVOTHYROXINE SODIUM

LLOYD
MYLAN

0.025MG
0.025MG

AB4
AB4

021116
076187

001
001

Patent Certification(s) Reference Listed Drug based upon a suitability

petition. An abbreviated new drug application that refers to a Reference
Listed Drug (RLD) approved pursuant to a suitability petition must demonstrate
that the proposed product is bioequivalent to the RLD, and it must include
appropriate patent certification(s) and an exclusivity statement with respect
to the listed drug which served as the basis for the approved suitability
petition. This concept also applies to an ANDA applicant that cites a RLD
that was based upon an NDA that is still covered by patent (s) and/or

xxi

exclusivity, e.g. a second RLD that was selected when the in vivo
determination of bioequivalence of the original RLD is self evident and the
waiver of the in vivo determination of bioequivalence may be granted.
Waived exclusivity. If a new drug application (NDA) submitted under
section 505(b) of the Federal Food, Drug, and Cosmetic Act (Act) qualifies for
exclusivity under sections 505(c)(3)(D) and 505(j)(5)(D), the exclusivity is
listed in the Patent and Exclusivity Section of the Orange Book. If a drug
product has received this exclusivity, the FDA will delay the approval of a
505(b)(2) application or an abbreviated new drug application (ANDA) under
section 505(j) of the Act until the expiration of the exclusivity. If the
listed drug is also protected by one or more patents, the approval date for
the 505(b)(2) application or ANDA will be determined by the latest expiring
patent or exclusivity listed in the Orange Book. However, the holder of the
NDA may waiver its exclusivity as to any or all 505(b)(2) and ANDA
applications referencing the protected drug product. If an NDA sponsor
waivers its right to the exclusivity protection, qualified 505(b)(2) or ANDA
applications may be approved without regard to the NDA holder's exclusivity.
An NDA for which the holder has waived its exclusivity as to all 505(b)(2) and
ANDA applications will be coded with a W in the Patent and Exclusivity Section
of the Orange Book and be referred to this section. The applicant referencing
this listed drug should indicate in the exclusivity statement that the holder
of the listed drug has waived its exclusivity.

1.9 Therapeutic Equivalence Code Change for a Drug Entity

The Agency will use the following procedures when, in response to a
petition or on its own initiative, it is considering a change in the
therapeutic equivalence code for approved multi-source drug products. Such
changes will generally occur when the Agency becomes aware of new scientific
information affecting the therapeutic equivalence of an entire category of
drug products in the List (e.g., information concerning the active ingredient
or the dosage form), rather than information concerning a single drug product
within the category. These procedures will be used when a change in
therapeutic equivalence code is under consideration for all drug products
found in the Prescription Drug Product List under a specific drug entity and
dosage form. The change may be from the code signifying that the drug does
not present a bioequivalence problem (e.g., AA) to a code signifying a
bioequivalence problem (e.g., BP), or vice versa. This procedure does not
apply to a change of a particular product code (e.g., a change from BP to AB
or from AB to BX).
Before making a change in a therapeutic equivalence code for an entire
category of drugs, the Agency will announce in the Introduction to the
Cumulative Supplement that it is considering the change and will invite
comment. Comments, along with scientific data, may be sent to the Director,
Division of Bioequivalence, Office of Generic Drugs, Center for Drug
Evaluation and Research, HFD-650, 7620 Standish Place, Rockville, MD 20855.
The comment period will generally be 60 days in length, and the closing
date for comments will be listed in the description of the proposed change for
each drug entity.
The most useful type of scientific data submission is an in vivo
bioavailability/bioequivalence study conducted on batches of the subject drug
products. These submissions should present a full description of the
analytical procedures and equipment used, a validation of the analytical
methodology, including the standard curve, a description of the method of
calculating results, and a description of the pharmacokinetic and statistical
models used in analyzing the data. Anecdotal or testimonial information is
the least useful to the Agency, and such submissions are discouraged. Copies

xxii

of supporting reports published in the scientific literature or unpublished

material, however, are welcome.

1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product

The aforementioned procedure does not apply to a change in a single drug
product code. For example, a change in a single drug product's code from BP
to AB as a result of the submission of an acceptable bioequivalence study
ordinarily will not be the subject of notice and comment. Likewise, a change
in a single drug product's code from AB to BX (e.g., as a result of new
information raising a significant question as to bioequivalence) does not
require notice and comment. The Agency's responsibility to provide the public
with the Agency's most current information related to therapeutic equivalence
may require a change in a drug product's code prior to any formal notice and
opportunity for the applicant to be heard. The publication in the Federal
Register of a proposal to withdraw approval of a drug product will ordinarily
result in a change in a product's code from AB to BX if this action has not
already been taken.
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). FR Safety or Effectiveness Determinations
List 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.
Generally, approved products are added to the Discontinued Section of the
Orange Book when the applicant holder notifies the Orange Book staff of the
products not marketed status. Products may also be added if annual reports
indicate the product is no longer marketed or other Agency administrative
action (e.g., Withdrawal of an Application). Changes to the Orange Book are
not affected by the drug registration and listing requirements of Section 510
of the Act.

xxiii

1.12 Changes to the Orange Book

Every effort is made to ensure the Annual Edition is current and
accurate. Applicant holders are requested to inform the FDA Orange Book Staff
(OBS) of any changes or corrections. Please inform the OBS when products are
no longer marketed. Notification of the Orange Book staff to include the
newly approved product in the Discontinued Drug Product List rather than parts
1, 2 or 3 of the List (as discussed in Section 1.1) must occur by the end of
the month in which the product is approved to ensure that the product is not
included in the active portions of the next published Orange Book update
We can be contacted by email at drugproducts@fda.hhs.gov.
FAX: 240-276-8974; mail to:

Send Changes by

FDA/CDER Orange Book Staff

Office of Generic Drugs, HFD-610
7620 Standish Place
Rockville, MD 20855

1.13 Availability of the Edition

Commencing with the 25th edition, the Annual Edition and current monthly
Cumulative Supplement are available in a Portable Document Format (PDF) at the
EOB home page, Electronic Orange Book Query, by clicking on Publications. The
PDF annual format duplicates previous paper versions except for the Orphan
Products Designations and Approvals List. An annual subscription of the PDF
format may be obtained from the U.S. Government Printing Office, 866-512-1800.

xxiv

2. HOW TO USE THE DRUG PRODUCT LISTS

2.1

Key Sections for Using the Drug Product Lists

This publication contains illustrations, along with Drug Product Lists,

indices, and lists of abbreviations and terms which facilitate their use.
Illustrations. The annotated Drug Product Illustration, see Section
2.2, and the Therapeutic Equivalence Evaluations Illustration, see
Section 2.3, are offered to provide further clarification. These depict the
format found in the Prescription Drug Product List (the only list in which
therapeutic equivalence evaluation codes are displayed).
Drug Product Lists. The Prescription and OTC Drug Product Lists,
arranged alphabetically by active ingredient(s), contain product
identification information (active ingredients, dosage forms, routes of
administration, product names, application holders, strengths) for single and
multiple ingredient drug products. Also shown are the application number and
drug product number (FDA internal computer data use only) and approval dates
for those drug products approved on or after January 1, 1982. The application
number preceded by N is a New Drug Application (NDA or commonly the
innovator). The application number preceded by an A is an Abbreviated New
Drug Application (ANDA or commonly the generic).
The Discontinued Product List, arranged alphabetically by active
ingredient(s), contains product identification information (dosage form,
product name, strength, and application number).
If a prescription drug product is available from more than one source
(multisource), a therapeutic equivalence code will appear in front of the
applicant's name. If a product is therapeutically equivalent to one or more
products or to an appropriate reference, it will be designated with a code
beginning with "A" and the entry will be underlined and printed in bold font
for emphasis.
Active ingredient headings for multiple ingredient (combination) drug
products are arranged alphabetically. For purposes of this publication, this
alphabetical sort takes precedence over United States Pharmacopeia official
monograph order (i.e., Reserpine, Hydralazine Hydrochloride,
Hydrochlorothiazide). For example, product information labeled as Reserpine,
Hydrochlorothiazide and Hydralazine Hydrochloride appears under the active
ingredient heading Hydralazine Hydrochloride; Hydrochlorothiazide; Reserpine.
A cross-reference to the product information (for prescription and OTC
products) appears for each additional active ingredient in the product. For
combination drug products, the ingredient strengths are separated by
semicolons and appear in the same relative sequence as the ingredients in the
heading. Available strengths of the dosage form from an applicant appear on
separate lines.
To use the Drug Product Lists, determine by alphabetical order the
ingredient under which the product information is listed, using the Product
Name Index, if necessary. Then, find the ingredient in the applicable Drug
Product List. Proceed to the dosage form and route of administration and
compare products within that ingredient heading only. Therapeutic equivalence
or inequivalence for prescription products is determined on the basis of the
therapeutic equivalence codes provided within that specific dosage form and
route heading. The OTC Drug Product List, Discontinued Drug Product List, and

2-1

Drug Products with Approval under Section 505 of the Act Administered by the
Center for Biologics Evaluation and Research List have their data arranged
similarly.
The Discontinued Drug Product List contains approved products that have
never been marketed, have been discontinued from marketing, are for military
use, or have had their approvals withdrawn for other than safety or efficacy
reasons subsequent to being discontinued from marketing. All products having
a "@" in the 12th Cumulative Supplement of the 31st Edition List have been
added to the Discontinued Drug Product List appearing in the 32nd Edition. In
addition, approved drug products that are not in the commercial distribution
channel e.g., approved drug products in applications for export only are also
listed in the Discontinued Section of the Orange Book.
Product Name Index (Prescription and OTC Drug Product Lists). This is an
index of drug products by established or trade name. The second term of each
entry indicates the active ingredient name under which product information can
be found in the appropriate Drug Product List. For those drug products with
multiple active ingredients, only the first active ingredient (in alphabetical
order) will appear. OTC products are so designated.
Product Name Index Listed by Applicant (Prescription and OTC Drug
Product Lists). This is an index that cross-references applicants to drug
products. The bolded and underlined entry represents the applicant name
abbreviation used in this publication. Each complete applicant name that is
represented by the abbreviated name is marked with an asterisk (*). Listed
under each complete applicant name is the first alphabetically arranged
ingredient under which product information can be found in the appropriate
Drug Product List. OTC products are so designated. To use the Drug Product
Lists, determine by alphabetical order the ingredient under which the product
information is listed, using the Product Name Index, if appropriate.
Uniform Terms. To improve readability, uniform terms are used to
designate dosage forms, routes of administration, and abbreviations used to
express strengths. These terms are listed in Appendix C. In some cases, the
terms used may differ from those used in product labels and other labeling.

2-2

2.2

DRUG PRODUCT ILLUSTRATION

SINGLE INGREDIENT

ACTIVE INGREDIENT

MEPERIDINE HYDROCHLORIDE

DOSAGE FORM; ROUTE OF ADMINISTRATION

INJECTABLE;INJECTION
HEXANON

TRADE OR GENERIC NAMES

AP + PAGE PHARMA

AP +
AP +

25MG/ML

50MG/ML

75MG/ML

REFERENCE LISTED DRUG

AP +

100MG/ML

THERAPEUTIC EQUIVALENCE (TE)

AP
AP
AP

CODE FOR MULTISOURCE PRODUCT

MEPERIDINE HCL
GREENBERG PHARM

25MG/ML
50MG/ML
75MG/ML

AP

N13111 001
N13111 002
N13111 003
AUG 22, 1983
N13111 004
JAN 04, 1985
A64890 001
A79421 001
A66331 002
AUG 27, 1987
A66331 003

FINAL APPROVAL DATE

SINGLE SOURCE PRODUCT (NO TE CODE)

AP

HOLOVAC LLC

RHONDA PHARM

10MG/ML
25MG/ML
150MG/ML

A99225 001
A99226 001
A79444 001

JOHNSON MED

APPLICANT
AVAILABLE STRENGTH(S) OF A PRODUCT
APPLICATION NUMBER AND PRODUCT NUMBER
PRODUCT NUMBER IS FOR FDA INTERNAL COMPUTER DATA USE ONLY

100MG/ML

MULTIPLE INGREDIENTS WITH PRODUCT INFORMATION

ALPHABETICALLY SORTED BY
ACTIVE INGREDIENT
PRODUCT INFORMATION

THIS EXAMPLE IS FOR PURPOSES OF ILLUSTRATION ONLY.

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

TABLET; ORAL
HYDROCHLOROTHIAZIDE, RESERPINE AND HYDRALAZINE HCL
MADISON
25MG;15MG;0.1MG A69808 001
AUG 27, 1987
JAN 18, 1982

IT DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE PRESCRIPTION DRUG PRODUCT LIST.

2.3

THERAPEUTIC EQUIVALENCE EVALUATIONS ILLUSTRATION

DRUG PRODUCTS CODED AB (OR ANY CODE BEGINNING WITH AN "A") UNDER AN INGREDIENT AND DOSAGE FORM HEADING ARE CONSIDERED
THERAPEUTICALLY EQUIVALENT ONLY TO OTHER PRODUCTS CODED AB (OR ANY CODE BEGINNING WITH AN A") AND NOT TO THOSE CODED BP (OR ANY
CODE BEGINNING WITH "B") AND ANY PRODUCTS NOT LISTED. DRUG PRODUCTS CODED BP (OR ANY CODE BEGINNING WITH A "B") ARE NOT CONSIDERED
THERAPEUTICALLY EQUIVALENT TO ANY OTHER PRODUCT. FOR A COMPLETE EXPLANATION OF THE TE CODES REFER TO SECTION 1.7 OF THE
INTRODUCTION.

SULFASALAZINE
TABLET; ORAL
FAZINE
AB

PARKLAND

PRODUCTS CONSIDERED THERAPEUTICALLY

500MG

A42999 001

500MG

A42222 001

500MG

A41297 001

500MG

A42999 001

BROWN

500MG

A41297 001

SOUTH

500MG

A67627 001

SULAZINE
AB

URSA

EQUIVALENT TO EACH OTHER

SULFASALAZINE
PRODUCTS CONSIDERED NOT THERAPEUTICALLY

BP

BROWN

EQUIVALENT TO ANY OTHER PRODUCTS LISTED

SULFASALAZINE
TABLET; ORAL
FAZINE
AB
PRODUCTS CONSIDERED NOT THERAPEUTICALLY

PARKLAND
SULFASALAZINE

BP
EQUIVALENT TO EACH OTHER

NOTE: BOLD FONT AND UNDERLINING DENOTES MULTISOURCE PRODUCTS WHICH ARE CONSIDERED THERAPEUTICALLY EQUIVALENT.
THIS EXAMPLE IS FOR PURPOSES OF ILLUSTRATION ONLY.

IT DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE PRESCRIPTION DRUG PRODUCT LIST.

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 1 (of 424)

ABACAVIR SULFATE
SOLUTION; ORAL

ZIAGEN

XX + VIIV HLTHCARE

EQ 20MG BASE/ML

N020978 001

Dec 17, 1998

TABLET; ORAL

ZIAGEN

XX + VIIV HLTHCARE

EQ 300MG BASE

N020977 001

Dec 17, 1998

N021652 001

Aug 02, 2004

EQ 300MG BASE;150MG;300MG

N021205 001

Nov 14, 2000

250MG

N202379 001

Apr 28, 2011

TABLET, DELAYED RELEASE; ORAL

CAMPRAL

333MG
XX + FOREST LABS

N021431 001

Jul 29, 2004

25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG

A078441
A078441
A078441
A091053
A091053
A091053
A078470
A078470
A078470
A090912
A090912
A090912
A077532
A077532
A077532

May
May
May
Jan
Jan
Jan
May
May
May
Jul
Jul
Jul
May
May
May

25MG
50MG
100MG

N020482 004
N020482 001
N020482 002

May 29, 1997

Sep 06, 1995
Sep 06, 1995

A075047
A075047
A074288
A074288
A074007

Dec
Dec
Apr
Apr
Oct

ABACAVIR SULFATE; LAMIVUDINE

TABLET; ORAL

EPZICOM

XX + VIIV HLTHCARE

EQ 600MG BASE;300MG

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

TABLET; ORAL

TRIZIVIR

XX + VIIV HLTHCARE

ABIRATERONE ACETATE
TABLET; ORAL

ZYTIGA

XX + JANSSEN BIOTECH

ACAMPROSATE CALCIUM

ACARBOSE
TABLET; ORAL
ACARBOSE
IMPAX LABS
AB
AB
AB
MYLAN
AB
AB
AB
ROXANE
AB
AB
AB
STRIDES ARCOLAB LTD
AB
AB
AB
WATSON LABS
AB
AB
AB
PRECOSE
AB + BAYER HLTHCARE
AB
AB

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

14,
14,
14,
06,
06,
06,
07,
07,
07,
27,
27,
27,
07,
07,
07,

2009
2009
2009
2011
2011
2011
2008
2008
2008
2011
2011
2011
2008
2008
2008

ACEBUTOLOL HYDROCHLORIDE

AB
AB
AB
AB
AB

CAPSULE; ORAL
ACEBUTOLOL HYDROCHLORIDE
AMNEAL PHARM
EQ
EQ
MYLAN
EQ
EQ
WATSON LABS
EQ

200MG
400MG
200MG
400MG
200MG

BASE
BASE
BASE
BASE
BASE

001
002
001
002
001

30,
30,
24,
24,
18,

1999
1999
1995
1995
1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 2 (of 424)

ACEBUTOLOL HYDROCHLORIDE
CAPSULE; ORAL
ACEBUTOLOL HYDROCHLORIDE
WATSON LABS
AB
EQ 400MG BASE
SECTRAL
PROMIUS PHARMA
AB
EQ 200MG BASE
AB +
EQ 400MG BASE

A074007 002

Oct 18, 1995

N018917 001
N018917 003

Dec 28, 1984

Dec 28, 1984

1000MG/100ML (10MG/ML)

N022450 001

Nov 02, 2010

650MG;50MG

A088831 001

Jun 19, 1985

A089987 001

Oct 26, 1992

A087811 001

Jun 19, 1985

A090956 001

Aug 23, 2011

A089988 001

Oct 26, 1992

A040261 001

Oct 28, 1998

A040085 001

Mar 28, 1996

A089007 001
A040885 001

Mar 17, 1986

Nov 16, 2009

A040387 001

Jan 31, 2003

A087804
A089175
A040864
A040883
A040511
A040513
A040267
A089718
A040336

Jan
Jan
Dec
Dec
Aug
Aug
Jul
Jun
Aug

ACETAMINOPHEN
SOLUTION; IV (INFUSION)

OFIRMEV

XX + CADENCE PHARMS

ACETAMINOPHEN; BUTALBITAL
CAPSULE; ORAL

PHRENILIN FORTE

XX + VALEANT

AA
AA
XX
XX

TABLET; ORAL
BUTAPAP
MIKART
325MG;50MG
PHRENILIN
+ VALEANT
325MG;50MG
BUTALBITAL AND ACETAMINOPHEN
NEXGEN PHARMA
300MG;50MG
BUTAPAP
+ MIKART
650MG;50MG

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

AA
AA
XX
XX

CAPSULE; ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
WEST WARD
500MG;50MG;40MG
ESGIC-PLUS
+ MIKART
500MG;50MG;40MG
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
+ MIKART
325MG;50MG;40MG
+ NEXGEN PHARMA
300MG;50MG;40MG

SOLUTION; ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

325MG/15ML;50MG/15ML;40MG/15ML
XX + MIKART

AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
XX

TABLET; ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
MALLINCKRODT
325MG;50MG;40MG
MIKART
325MG;50MG;40MG
MIRROR PHARMS
325MG;50MG;40MG
500MG;50MG;40MG
VINTAGE PHARMS
325MG;50MG;40MG
500MG;50MG;40MG
WATSON LABS
500MG;50MG;40MG
WEST WARD
325MG;50MG;40MG
500MG;50MG;40MG
ESGIC-PLUS
500MG;50MG;40MG
+ MIKART
FIORICET
+ WATSON PHARMS
325MG;50MG;40MG
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
+ MIKART
750MG;50MG;40MG

001
001
001
001
001
001
001
001
001

24,
21,
01,
23,
27,
25,
30,
12,
18,

1985
1987
2008
2008
2003
2003
1998
1995
1999

A089451 001

May 23, 1988

A088616 001

Nov 09, 1984

A040496 001

Dec 23, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 3 (of 424)

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE; ORAL
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
NEXGEN PHARMA INC
325MG;50MG;40MG;30MG
VINTAGE PHARMS
325MG;50MG;40MG;30MG
WEST WARD
325MG;50MG;40MG;30MG
FIORICET W/ CODEINE
+ WATSON LABS INC
325MG;50MG;40MG;30MG
PHRENILIN WITH CAFFEINE AND CODEINE
VALEANT
325MG;50MG;40MG;30MG

A076560 001
A075929 001
A075618 001

Jun 10, 2004

Apr 22, 2002
Mar 23, 2001

N020232 001

Jul 30, 1992

A074911 001

Aug 22, 2001

CAPSULE; ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
AA + MIKART
356.4MG;30MG;16MG
WRASER PHARMS LLC
AA
356.4MG;30MG;16MG

A040109 001
A040688 001

Aug 26, 1997

Apr 03, 2007

TABLET; ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
BOCA PHARMA
AA
712.8MG;60MG;32MG
AA + MIKART
712.8MG;60MG;32MG

A040701 001
A040316 001

Apr 03, 2007

Apr 28, 1999

A040119
A089450
A087508
A091238
A087006

Apr 26, 1996

Oct 27, 1992

AB
AB
AB
AB
AB

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

ACETAMINOPHEN; CODEINE PHOSPHATE

AA
AA
AA
AA
AA

SOLUTION; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
HI TECH PHARMA
120MG/5ML;12MG/5ML
MIKART
120MG/5ML;12MG/5ML
PHARM ASSOC
120MG/5ML;12MG/5ML
VINTAGE PHARMS
120MG/5ML;12MG/5ML
WOCKHARDT
120MG/5ML;12MG/5ML

SUSPENSION; ORAL
CAPITAL AND CODEINE
AA + VALEANT

AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
XX
XX

120MG/5ML;12MG/5ML

TABLET; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
AMNEAL PHARMS NY
300MG;30MG
+ MALLINCKRODT INC
300MG;15MG
300MG;30MG
300MG;60MG
MIKART
300MG;30MG
RANBAXY
300MG;30MG
300MG;60MG
TEVA
300MG;15MG
300MG;30MG
+
300MG;60MG
VINTAGE
300MG;15MG
300MG;30MG
VINTAGE PHARMS
300MG;60MG
TYLENOL W/ CODEINE NO. 3
+ JANSSEN PHARMS
300MG;30MG
TYLENOL W/ CODEINE NO. 4
JANSSEN PHARMS
300MG;60MG
ACETAMINOPHEN AND CODEINE PHOSPHATE
+ MIKART
650MG;30MG
+
650MG;60MG

001
001
001
001
001

Nov 10, 2011

A086024 001

A040779
A040419
A040419
A040419
A089238
A085868
A087083
A088627
A088628
A088629
A089990
A089805
A089828

001
001
002
003
001
001
001
001
001
001
001
001
001

May
May
May
May
Feb

29,
31,
31,
31,
25,

2008
2001
2001
2001
1986

Mar
Mar
Mar
Sep
Sep
Sep

06,
06,
06,
30,
30,
30,

1985
1985
1985
1988
1988
1988

A085055 003
A085055 004
A089231 001
A089363 001

Mar 03, 1986

Sep 09, 1991

A081067 001

Nov 30, 1989

ACETAMINOPHEN; HYDROCODONE BITARTRATE

CAPSULE; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MIKART
AA
500MG;5MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 4 (of 424)

ACETAMINOPHEN; HYDROCODONE BITARTRATE

CAPSULE; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MIKART
AA
500MG;5MG

AA
AA
AA
AA
AA
AA
AA
XX
XX

SOLUTION; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
BOCA PHARMA
325MG/15ML;7.5MG/15ML
MALLINCKRODT
500MG/15ML;7.5MG/15ML
+ MIKART
325MG/15ML;7.5MG/15ML
+
500MG/15ML;7.5MG/15ML
NESHER PHARMS
500MG/15ML;7.5MG/15ML
PHARM ASSOC
500MG/15ML;7.5MG/15ML
VINTAGE PHARMS
500MG/15ML;7.5MG/15ML
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
+ MIKART
300MG/15ML;10MG/15ML
+ PHARM ASSOC
325MG/15ML;10MG/15ML

TABLET; ORAL
ANEXSIA
MALLINCKRODT
AA
500MG;5MG
AA
750MG;10MG
ANEXSIA 5/325
MALLINCKRODT
AA
325MG;5MG
ANEXSIA 7.5/325
MALLINCKRODT
AA
325MG;7.5MG
ANEXSIA 7.5/650
MALLINCKRODT
AA
650MG;7.5MG
CO-GESIC
UCB INC
AA
500MG;5MG
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AMNEAL PHARMS NY
AA
325MG;5MG
AA
325MG;10MG
AA
500MG;5MG
AA
500MG;7.5MG
AA
500MG;10MG
AA
650MG;7.5MG
AA
650MG;10MG
AA
750MG;7.5MG
BOCA PHARMA
AA
300MG;5MG
AA
300MG;7.5MG
AA
300MG;10MG
MALLINCKRODT
AA
325MG;10MG
AA
500MG;5MG
AA
500MG;7.5MG
AA
500MG;10MG
AA
650MG;10MG
AA +
660MG;10MG
AA
750MG;7.5MG
AA + MIKART
300MG;5MG
AA +
300MG;7.5MG
AA +
300MG;10MG
AA
325MG;7.5MG
AA +
500MG;2.5MG
AA +
500MG;7.5MG
AA +
650MG;7.5MG
AA +
650MG;10MG
SUN PHARM INDS INC
AA
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
AA
500MG;5MG
AA
500MG;7.5MG

A089008 001

Feb 21, 1986

A040894
A040418
A040482
A081051
A040366
A040182
A040520

Jul
Jun
Sep
Aug
Jan
Mar
Oct

001
001
001
001
001
001
001

19,
27,
25,
28,
23,
13,
30,

2011
2001
2003
1992
2002
1998
2003

A040881 001
A040834 001

Feb 25, 2010

Apr 18, 2008

A089160 001
A040468 001

Apr 23, 1987

Oct 31, 2002

A040409 001

Oct 20, 2000

A040405 001

Sep 08, 2000

A089725 001

Sep 30, 1987

A087757 001

May 03, 1982

A040736
A040746
A040729
A040748
A040813
A040754
A040757
A040769
A090415
A090415
A090415
A040400
A040084
A040201
A040201
A040084
A040084
A040084
A040658
A040556
A040556
A040432
A089698
A089699
A089689
A081223
A090118
A090118
A090118
A090265
A090265

Aug
Aug
Aug
Aug
Feb
Aug
Aug
Aug
Jan
Jan
Jan
Jul
Jun
Feb
Feb
Oct
Jul
Jun
Jan
Mar
Jun
Jan
Aug
Aug
Jun
May
Dec
Dec
Dec
Dec
Dec

001
001
001
001
001
001
001
001
001
002
003
001
002
001
002
004
003
001
001
002
001
001
001
001
001
001
001
002
003
001
002

25,
25,
25,
25,
23,
25,
25,
28,
24,
24,
24,
26,
01,
27,
27,
16,
29,
01,
19,
24,
23,
22,
25,
25,
29,
29,
23,
23,
23,
23,
23,

2006
2006
2006
2006
2007
2006
2006
2006
2011
2011
2011
2000
1995
1998
1998
1996
1996
1995
2006
2006
2004
2003
1989
1989
1988
1992
2008
2008
2008
2008
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 5 (of 424)

ACETAMINOPHEN; HYDROCODONE BITARTRATE

TABLET; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
SUN PHARM INDS INC
AA
500MG;10MG
AA
650MG;7.5MG
AA
650MG;10MG
AA
660MG;10MG
AA
750MG;7.5MG
VINTAGE PHARMS
AA
325MG;5MG
AA
325MG;7.5MG
AA
325MG;10MG
AA
500MG;2.5MG
AA
500MG;5MG
AA
500MG;7.5MG
AA
500MG;10MG
AA
650MG;7.5MG
AA
650MG;10MG
AA
660MG;10MG
AA
750MG;7.5MG
WATSON LABS
AA
500MG;2.5MG
AA
500MG;5MG
AA
500MG;7.5MG
AA
500MG;10MG
AA
650MG;7.5MG
AA
650MG;10MG
AA
660MG;10MG
AA
750MG;7.5MG
AA +
750MG;10MG
WATSON LABS FLORIDA
AA
660MG;10MG
LORTAB
UCB INC
AA
500MG;5MG
AA +
500MG;10MG
NORCO
AA + WATSON LABS
325MG;5MG
AA +
325MG;7.5MG
AA +
325MG;10MG
VICODIN
AA + ABBOTT
500MG;5MG
VICODIN ES
AA + ABBOTT
750MG;7.5MG
VICODIN HP
ABBOTT
AA
660MG;10MG
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MIKART
325MG;2.5MG
XX
650MG;5MG
XX
ZYDONE
400MG;5MG
XX + ENDO PHARMS
400MG;7.5MG
XX +
400MG;10MG
XX +

A090265
A090380
A090380
A090380
A090380
A040655
A040656
A040355
A040144
A089971
A040144
A040356
A040155
A040143
A040358
A040157
A081079
A089883
A081080
A040148
A040094
A040094
A040094
A081083
A040094
A040495

003
001
002
003
004
001
001
001
002
001
001
001
001
001
001
001
001
001
001
002
001
002
003
001
004
001

Dec
Dec
Dec
Dec
Dec
Jan
Jan
May
Apr
Dec
Feb
May
Apr
Feb
May
Apr
Aug
Dec
Aug
Feb
Sep
Sep
Aug
Aug
Mar
May

23,
23,
23,
23,
23,
19,
19,
31,
25,
02,
22,
31,
14,
22,
31,
12,
30,
01,
30,
14,
29,
29,
08,
30,
22,
28,

2008
2008
2008
2008
2008
2006
2006
2000
1997
1988
1996
2000
1997
1996
2000
1996
1991
1988
1991
1997
1995
1995
2000
1991
1999
2003

A087722 001
A040100 001

Jul 09, 1982

Jan 26, 1996

A040099 001
A040148 003
A040148 001

Jun 25, 1997

Sep 12, 2000
Feb 14, 1997

A088058 001

Jan 07, 1983

A089736 001

Dec 09, 1988

A040117 001

Sep 23, 1996

A040846 001
A040849 001

Jun 09, 2010

Jun 09, 2010

A040288 001
A040288 002
A040288 003

Nov 27, 1998

Nov 27, 1998
Nov 27, 1998

A040289
A040257
A040106
A040234

Mar
Aug
Jul
Oct

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

AA
AA
AA
AA
AA

CAPSULE; ORAL
OXYCODONE AND ACETAMINOPHEN
DURAMED PHARMS BARR
500MG;5MG
MALLINCKRODT
500MG;5MG
VINTAGE PHARMS
500MG;5MG
WATSON LABS
500MG;5MG
ROXILOX
ROXANE
500MG;5MG

001
001
001
001

A040061 001

16,
04,
30,
30,

1999
1998
1996
1997

Jul 03, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 6 (of 424)

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

CAPSULE; ORAL
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

A087463 001

Dec 07, 1983

A040777
A040778
A040789
A040789
A090177
A090177
A090177
A090177
A090177
A090177
A040545
A040545
A040550
A040550
A040105
A040171
A040535
A040535
A040371
A040371

001
001
001
002
001
002
003
004
005
006
001
002
001
002
001
001
001
002
001
002

Nov
Nov
Nov
Nov
Oct
Oct
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Jul
Oct
Sep
Sep
Dec
Dec

27,
27,
27,
27,
20,
20,
20,
20,
20,
20,
30,
30,
30,
30,
30,
30,
05,
05,
29,
29,

2007
2007
2007
2007
2008
2008
2008
2008
2008
2008
2004
2004
2004
2004
1996
1997
2003
2003
2000
2000

A040330
A040330
A040434
A040434
A040341
A040341

001
002
001
002
001
002

Jun
Jun
Nov
Nov
Jul
Jul

25,
25,
23,
23,
26,
26,

1999
1999
2001
2001
1999
1999

Dec
Dec
Dec
Dec
May
Apr
Apr
Apr
Apr

30,
30,
30,
30,
16,
27,
27,
27,
19,

2005
2005
2005
2005
2006
2006
2006
2006
2006

AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX

TABLET; ORAL
OXYCET
MALLINCKRODT
325MG;5MG
OXYCODONE AND ACETAMINOPHEN
AMNEAL PHARMS NY
325MG;5MG
325MG;10MG
500MG;7.5MG
650MG;10MG
COASTAL PHARMS
325MG;2.5MG
325MG;5MG
325MG;7.5MG
325MG;10MG
500MG;7.5MG
650MG;10MG
MALLINCKRODT
325MG;7.5MG
325MG;10MG
500MG;7.5MG
650MG;10MG
VINTAGE PHARMS
325MG;5MG
WATSON LABS
325MG;5MG
325MG;7.5MG
325MG;10MG
500MG;7.5MG
650MG;10MG
PERCOCET
+ ENDO PHARMS
325MG;2.5MG
+
325MG;5MG
+
325MG;7.5MG
+
325MG;10MG
+
500MG;7.5MG
+
650MG;10MG
ROXICET
ROXANE
325MG;5MG
OXYCODONE AND ACETAMINOPHEN
+ MIKART
300MG;2.5MG
+
300MG;5MG
+
300MG;7.5MG
+
300MG;10MG
+
400MG;2.5MG
+
400MG;5MG
+
400MG;7.5MG
+
400MG;10MG
500MG;10MG
ROXICET 5/500
+ ROXANE
500MG;5MG

A087003 001
A040608
A040608
A040608
A040608
A040679
A040687
A040698
A040692
A040676

001
002
003
004
001
001
001
001
001

A089775 001

Jan 12, 1989

A076202 001
A074699 001

Aug 02, 2002

Mar 24, 2000

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

TABLET; ORAL
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
GAVIS PHARMS
AB
650MG;EQ 25MG BASE
AB + WATSON LABS
650MG;EQ 25MG BASE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 7 (of 424)

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

AB
AB
AB
AB
AB
AB

TABLET; ORAL
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
AMNEAL PHARMS
325MG;37.5MG
CARACO
325MG;37.5MG
MYLAN
325MG;37.5MG
PAR PHARM
325MG;37.5MG
WATSON LABS
325MG;37.5MG
ULTRACET
+ JANSSEN PHARMS
325MG;37.5MG

A090485
A077184
A077858
A076475
A076914

001
001
001
001
001

Dec
Dec
Sep
Apr
Jul

09,
16,
26,
21,
26,

2009
2005
2008
2005
2006

N021123 001

Aug 15, 2001

A090779 001
A040904 001

Jul 14, 2011

Dec 10, 2008

ACETAZOLAMIDE
CAPSULE, EXTENDED RELEASE; ORAL
ACETAZOLAMIDE
HERITAGE PHARMS INC
AB
500MG
ZYDUS PHARMS USA INC 500MG
AB
DIAMOX
AB + DURAMED PHARMS BARR
500MG

AB
AB
AB
AB
AB

TABLET; ORAL
ACETAZOLAMIDE
LANNETT
MUTUAL PHARM
TARO
+
WATSON LABS

N012945 001

250MG
125MG
125MG
250MG
250MG

A084840
A089752
A040195
A040195
A088882

001
001
001
002
001

EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL

A040089 001
A040784 001

Feb 28, 1995

Dec 10, 2008

EQ 500MG BASE/VIAL

N009388 001

Dec 05, 1990

N018161 001
N018523 001
N017656 001

Feb 19, 1982

2%
2%
2%

A088638 001
A040607 001
A040166 001

Sep 06, 1984

Feb 24, 2005
Jul 26, 1996

2%

N012179 001

Jun
May
May
Oct

22,
28,
28,
22,

1988
1997
1997
1985

ACETAZOLAMIDE SODIUM
INJECTABLE; INJECTION
ACETAZOLAMIDE SODIUM
BEDFORD
AP
X GEN PHARMS
AP
DIAMOX
AP + DURAMED PHARMS BARR

ACETIC ACID, GLACIAL

SOLUTION; IRRIGATION, URETHRAL
ACETIC ACID 0.25% IN PLASTIC CONTAINER
B BRAUN
AT
250MG/100ML
BAXTER HLTHCARE
AT
250MG/100ML
HOSPIRA
AT
250MG/100ML

AT
AT
AT
AT

SOLUTION/DROPS; OTIC
ACETIC ACID
TARO
VINTAGE
+ WOCKHARDT
VOSOL
HI TECH PHARMA

ACETIC ACID, GLACIAL; ALUMINUM ACETATE

SOLUTION/DROPS; OTIC

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE

XX + BAUSCH AND LOMB

2%;0.79%

A040063 001

Feb 25, 1994

A087143 001

Jan 13, 1982

A088759 001

Mar 04, 1985

ACETIC ACID, GLACIAL; HYDROCORTISONE

SOLUTION/DROPS; OTIC
ACETASOL HC
ACTAVIS MID ATLANTIC 2%;1%
AT
HYDROCORTISONE AND ACETIC ACID
TARO
AT
2%;1%

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 8 (of 424)

ACETIC ACID, GLACIAL; HYDROCORTISONE

SOLUTION/DROPS; OTIC
HYDROCORTISONE AND ACETIC ACID
VINTAGE
AT
2%;1%
VOSOL HC
AT + HI TECH PHARMA
2%;1%

A040609 001

Feb 06, 2006

N012770 001

ACETOHEXAMIDE
TABLET; ORAL
ACETOHEXAMIDE
WATSON LABS
XX
XX +

250MG
500MG

A071893 001
A071894 001

Nov 25, 1987

Nov 25, 1987

250MG

N018749 001

May 31, 1983

20MG/VIAL

N020213 001

Sep 22, 1993

6GM/30ML (200MG/ML)

N021539 001

Jan 23, 2004

A072323
A072324
A073664
A074037
A072489
A072547

001
001
001
001
001
001

Apr
Apr
Aug
Aug
Jul
Jul

30,
30,
30,
30,
28,
28,

1992
1992
1994
1994
1995
1995

N019821
N019821
N019821
N019821

001
003
004
002

Oct
Aug
Aug
Oct

28,
06,
06,
28,

1996
2009
2009
1996

ACETOHYDROXAMIC ACID
TABLET; ORAL

LITHOSTAT

XX + MISSION PHARMA

ACETYLCHOLINE CHLORIDE
FOR SOLUTION; OPHTHALMIC

MIOCHOL-E

XX + BAUSCH AND LOMB

ACETYLCYSTEINE
INJECTABLE; INTRAVENOUS

ACETADOTE

XX + CUMBERLAND PHARMS

SOLUTION; INHALATION, ORAL

ACETYLCYSTEINE
BEDFORD
AN
10%
AN
20%
HOSPIRA
AN
10%
AN
20%
AN + LUITPOLD
10%
AN +
20%

ACITRETIN
CAPSULE; ORAL

SORIATANE

STIEFEL LABS INC

XX
XX
XX
XX +

10MG
17.5MG
22.5MG
25MG

ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE

CAPSULE; ORAL

SEMPREX-D

XX + UCB INC

8MG;60MG

N019806 001

Mar 25, 1994

200MG
200MG
200MG
200MG
200MG
200MG
200MG

A075677
A074833
A074727
A074977
A074975
A075090
A074578

Sep
Apr
Apr
Apr
Sep
Jan
Apr

ACYCLOVIR
CAPSULE; ORAL
ACYCLOVIR
APOTEX INC
AB
DAVA PHARMS INC
AB
MYLAN
AB
AB
RANBAXY
AB
STASON
AB
TEVA
AB

001
001
001
001
001
001
001

28,
22,
22,
13,
30,
26,
22,

2005
1997
1997
1998
1998
1999
1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 9 (of 424)

ACYCLOVIR
CAPSULE; ORAL
ACYCLOVIR
WATSON LABS
AB
ZOVIRAX
AB + GLAXOSMITHKLINE

200MG

A075101 001

Apr 15, 1998

200MG

N018828 001

Jan 25, 1985

CREAM; TOPICAL

ZOVIRAX

XX + VALEANT INTL

5%

N021478 001

Dec 30, 2002

OINTMENT; TOPICAL

ZOVIRAX

XX + VALEANT INTL

5%

N018604 001

Mar 29, 1982

200MG/5ML
200MG/5ML

A074738 001
A077026 001

Apr 28, 1997

Jun 07, 2005

200MG/5ML

N019909 001

Dec 22, 1989

400MG
800MG
400MG
800MG
400MG
800MG
400MG
400MG
800MG
800MG
400MG
800MG
400MG
800MG

A077309
A077309
A075382
A075382
A074946
A074946
A074976
A075211
A074976
A075211
A074980
A074980
A074556
A074556

Sep
Sep
Apr
Apr
Nov
Nov
Apr
Sep
Apr
Sep
Sep
Sep
Apr
Apr

400MG
800MG

N020089 001
N020089 002

Apr 30, 1991

Apr 30, 1991

A074930
A075015
A074913
A074913
A074596
A074596

May
Apr
Oct
Oct
Apr
Apr

SUSPENSION; ORAL
ACYCLOVIR
ACTAVIS MID ATLANTIC
AB
HI TECH PHARMA
AB
ZOVIRAX
AB + GLAXOSMITHKLINE
TABLET; ORAL
ACYCLOVIR
APOTEX INC
AB
AB
CARLSBAD
AB
AB
DAVA PHARMS INC
AB
AB
MYLAN
AB
AB
AB
AB
RANBAXY
AB
AB
TEVA
AB
AB
ZOVIRAX
GLAXOSMITHKLINE
AB
AB +

001
002
001
002
001
002
001
001
002
002
001
002
002
003

29,
29,
30,
30,
19,
19,
13,
28,
13,
28,
30,
30,
22,
22,

2005
2005
1999
1999
1997
1997
1998
1998
1998
1998
1998
1998
1997
1997

ACYCLOVIR SODIUM
INJECTABLE; INJECTION
ACYCLOVIR SODIUM
AP + APP PHARMS
EQ 50MG BASE/ML
AP +
EQ 500MG BASE/VIAL
BAXTER HLTHCARE
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
BEDFORD
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE
EQ 500MG BASE/VIAL
XX + BAXTER HLTHCARE
EQ 1GM BASE/VIAL
XX

001
001
001
002
002
001

13,
30,
15,
15,
22,
22,

1998
1998
1997
1997
1997
1997

A074885 001
A074885 002

Dec 19, 1997

Dec 19, 1997

N022436 001

Jul 31, 2009

ACYCLOVIR; HYDROCORTISONE
CREAM; TOPICAL

XERESE

XX + VALEANT INTL

5%;1%

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 10 (of 424)

ADAPALENE
CREAM; TOPICAL
ADAPALENE
NYCOMED US
AB
DIFFERIN
AB + GALDERMA LABS LP

AB
AB
AB
XX

GEL; TOPICAL
ADAPALENE
GLENMARK GENERICS
PLIVA HRVATSKA DOO
DIFFERIN
+ GALDERMA LABS LP
DIFFERIN
+ GALDERMA LABS LP

LOTION; TOPICAL

DIFFERIN

XX + GALDERMA R AND D

0.1%

A090824 001

Jun 30, 2010

0.1%

N020748 001

May 26, 2000

0.1%
0.1%

A091314 001
A090962 001

Jul 01, 2010

Jun 02, 2010

0.1%

N020380 001

May 31, 1996

0.3%

N021753 001

Jun 19, 2007

0.1%

N022502 001

Mar 17, 2010

0.1%;2.5%

N022320 001

Dec 08, 2008

10MG

N021449 001

Sep 20, 2002

3MG/ML

N019937 002

Oct 30, 1989

3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML

A078076
A077133
A076500
A076404
A077283
A090010
A078686
A076564
A078676
A090220

Oct
Apr
Jun
Jun
Jun
Apr
May
Jun
Jul
Jul

3MG/ML

N020059 001

May 18, 1995

200MG

N020666 001

Jun 11, 1996

10MG/ML

N020899 001

Dec 31, 1997

ADAPALENE; BENZOYL PEROXIDE

GEL; TOPICAL

EPIDUO

XX + GALDERMA LABS

ADEFOVIR DIPIVOXIL
TABLET; ORAL

HEPSERA

XX + GILEAD

ADENOSINE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
XX

INJECTABLE; INJECTION
ADENOCARD
+ ASTELLAS
ADENOSINE
AKORN
APP PHARMS
BAXTER HLTHCARE
BEDFORD
GLAND PHARMA LTD
LUITPOLD
STRIDES ARCOLAB LTD
TEVA PARENTERAL
WOCKHARDT
ADENOSCAN
+ ASTELLAS

001
001
001
001
001
001
001
001
001
001

31,
27,
16,
16,
14,
28,
13,
16,
31,
20,

2008
2005
2004
2004
2007
2009
2009
2004
2008
2009

ALBENDAZOLE
TABLET; ORAL

ALBENZA

XX + COREPHARMA

ALBUMIN HUMAN
INJECTABLE; INJECTION

OPTISON

XX + GE HEALTHCARE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 11 (of 424)

ALBUMIN IODINATED I-125 SERUM

INJECTABLE; INJECTION
JEANATOPE
ISO TEX
XX
XX
XX +

100UCI/10ML (10UCI/ML)
500uCi/0.5ML
1,000uCi/ML

N017836 003
N017836 001
N017836 002

Jun 08, 2004

ALBUMIN IODINATED I-131 SERUM

INJECTABLE; INJECTION

MEGATOPE

XX + ISO TEX
XX +

0.5mCi/VIAL
1mCi/VIAL

N017837 001
N017837 002

ALBUTEROL SULFATE
AEROSOL, METERED; INHALATION
PROAIR HFA
BX + TEVA GLOBAL
EQ 0.09MG BASE/INH
PROVENTIL-HFA
BX + 3M
EQ 0.09MG BASE/INH
VENTOLIN HFA
BX + GLAXOSMITHKLINE
EQ 0.09MG BASE/INH
SOLUTION; INHALATION
ACCUNEB
AN + DEY
AN +
ALBUTEROL SULFATE
APOTEX INC
AN
AN
AN
AN + BAUSCH AND LOMB
AN + DEY
HI TECH PHARMA
AN
AN
LANDELA PHARM
AN
NEPHRON
AN
AN
AN
AN
NOVEX
AN
RITEDOSE CORP
AN
TEVA PARENTERAL
AN
WATSON LABS
AN
AN
WATSON LABS INC
AN
WOCKHARDT
AN

AA
AA
AA
AA
AA
AA

SYRUP; ORAL
ALBUTEROL SULFATE
ACTAVIS MID ATLANTIC
AMNEAL PHARMS
HI TECH PHARMA
+ TEVA
VINTAGE
VISTAPHARM

TABLET; ORAL
ALBUTEROL SULFATE
MUTUAL PHARM
AB
AB
MYLAN
AB
AB +

N021457 001

Oct 29, 2004

N020503 001

Aug 15, 1996

N020983 001

Apr 19, 2001

EQ 0.021% BASE
EQ 0.042% BASE

N020949 002
N020949 001

Apr 30, 2001

Apr 30, 2001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

0.021% BASE
0.042% BASE
0.083% BASE
0.5% BASE
0.083% BASE
0.083% BASE
0.5% BASE
0.083% BASE
0.021% BASE
0.042% BASE
0.083% BASE
0.5% BASE
0.5% BASE
0.083% BASE
0.083% BASE
0.021% BASE
0.042% BASE
0.083% BASE
0.083% BASE

A078623
A078623
A075717
A075050
A072652
A075063
A074543
A077569
A076355
A076355
A074880
A075664
A076391
A077839
A075343
A077772
A077772
A076370
A075394

001
002
001
001
001
001
001
001
002
001
001
001
001
001
001
001
002
001
001

Apr
Apr
Feb
Jun
Feb
Feb
Jan
Apr
Mar
Jun
Sep
Jun
Apr
Dec
Nov
Sep
Sep
Nov
Nov

05,
05,
02,
18,
21,
09,
15,
04,
31,
28,
17,
26,
01,
16,
09,
25,
25,
24,
22,

2010
2010
2007
1998
1992
1999
1998
2006
2010
2004
1997
2001
2003
2008
1999
2007
2007
2003
1999

EQ
EQ
EQ
EQ
EQ
EQ

2MG
2MG
2MG
2MG
2MG
2MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A074454
A079241
A074749
A073419
A078105
A077788

001
001
001
001
001
001

Sep
May
Jan
Mar
Dec
Jun

25,
12,
30,
30,
27,
26,

1995
2010
1998
1992
2006
2007

EQ
EQ
EQ
EQ

2MG
4MG
2MG
4MG

BASE
BASE
BASE
BASE

A072637
A072637
A072894
A072894

002
001
002
001

Dec
Dec
Jan
Jan

05,
05,
17,
17,

1989
1989
1991
1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 12 (of 424)

ALBUTEROL SULFATE
TABLET; ORAL
ALBUTEROL SULFATE
WATSON LABS
AB

A072764 001

Aug 28, 1991

BASE
BASE

A078092 002
A078092 001

Jan 29, 2007

Jan 29, 2007

BASE
BASE

A076130 002
A076130 003

Sep 26, 2002

Sep 26, 2002

N020291 001

Oct 24, 1996

A077117
A076749
A076867
A076724
A077063
A077559

Dec
Dec
Dec
Dec
Dec
Dec

EQ 2MG BASE

TABLET, EXTENDED RELEASE; ORAL

ALBUTEROL SULFATE
MYLAN
AB
EQ 4MG
AB
EQ 8MG
VOSPIRE ER
DAVA PHARMS INC
AB
EQ 4MG
AB +
EQ 8MG

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

AEROSOL, METERED; INHALATION

COMBIVENT

XX + BOEHRINGER INGELHEIM EQ 0.09MG BASE/INH;0.018MG/INH

AN
AN
AN
AN
AN
AN
AN

SOLUTION; INHALATION
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
APOTEX CORP
EQ 0.083% BASE;0.017%
NEPHRON
EQ 0.083% BASE;0.017%
SANDOZ
EQ 0.083% BASE;0.017%
TEVA PARENTERAL
EQ 0.083% BASE;0.017%
WATSON LABS
EQ 0.083% BASE;0.017%
EQ 0.083% BASE;0.017%
DUONEB
+ DEY
EQ 0.083% BASE;0.017%

SPRAY, METERED; INHALATION

COMBIVENT RESPIMAT

XX + BOEHRINGER INGELHEIM EQ 0.1MG BASE/INH;0.02MG/INH

001
001
001
001
001
001

31,
31,
21,
31,
31,
31,

2007
2007
2006
2007
2007
2007

N020950 001

Mar 21, 2001

N021747 001

Oct 07, 2011

N022134 001

Jul 28, 2010

N018707 001

Dec 14, 1982

A076973 001
A079061 001
A076587 001

Jul 12, 2005

Jun 23, 2009
Sep 15, 2005

N018702 001

Dec 14, 1982

A076884 001
A079227 001
A076730 001

Jul 18, 2005

Jul 30, 2009
Jul 29, 2004

ALCAFTADINE
SOLUTION/DROPS; OPHTHALMIC

LASTACAFT

XX + ALLERGAN
0.25%

ALCLOMETASONE DIPROPIONATE

AB
AB
AB
AB

AB
AB
AB
AB

CREAM; TOPICAL
ACLOVATE
+ FOUGERA PHARMS
0.05%
ALCLOMETASONE DIPROPIONATE
ALTANA
0.05%
GLENMARK GENERICS
0.05%
TARO
0.05%
OINTMENT; TOPICAL
ACLOVATE
+ FOUGERA PHARMS
0.05%
ALCLOMETASONE DIPROPIONATE
ALTANA
0.05%
GLENMARK GENERICS
0.05%
TARO
0.05%

ALCOHOL; DEXTROSE
INJECTABLE; INJECTION
ALCOHOL 5% AND DEXTROSE 5%
AP + B BRAUN
5ML/100ML;5GM/100ML
ALCOHOL 10% AND DEXTROSE 5%
10ML/100ML;5GM/100ML
XX + B BRAUN

N004589 004
N004589 006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 13 (of 424)

ALENDRONATE SODIUM
SOLUTION; ORAL

FOSAMAX

XX + MERCK
TABLET; ORAL
ALENDRONATE SODIUM
APOTEX
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AUSTARPHARMA LLC
AB
AB
AB
AB
CADISTA PHARMS
AB
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
SUN PHARMA GLOBAL
AB
AB
AB
AB
TEVA PHARMS
AB
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
AB
AB
AB
AB
FOSAMAX
MERCK AND CO INC
AB
AB
AB
AB
AB +

EQ 70MG BASE/75ML

N021575 001

Sep 17, 2003

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
35MG BASE
70MG BASE
10MG BASE
35MG BASE
70MG BASE
5MG BASE
10MG BASE
35MG BASE
70MG BASE
5MG BASE
10MG BASE
35MG BASE
70MG BASE
5MG BASE
10MG BASE
35MG BASE
70MG BASE
5MG BASE
10MG BASE
35MG BASE
35MG BASE
70MG BASE
70MG BASE
5MG BASE
10MG BASE
35MG BASE
70MG BASE
5MG BASE
10MG BASE
35MG BASE
40MG BASE
70MG BASE
5MG BASE
10MG BASE
35MG BASE
35MG BASE
40MG BASE
40MG BASE
70MG BASE
70MG BASE

A077982
A077982
A077982
A077982
A090124
A090124
A090124
A090258
A090258
A090258
A090258
A090557
A090557
A090557
A090557
A079109
A079109
A079049
A079049
A076584
A076584
A076584
A078638
A076584
A078638
A090022
A090022
A090022
A090022
A075710
A075710
A075710
A075710
A075710
A076768
A076768
A076768
A076984
A076768
A076984
A076768
A076984

001
002
003
004
001
002
003
001
002
003
004
001
002
003
004
001
002
001
002
001
002
003
001
004
002
001
002
003
004
001
002
003
004
005
001
002
003
001
004
002
005
003

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep
Feb
Feb
Feb
Feb
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep
Feb
Feb
Feb
Feb
Feb
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug

04,
04,
04,
04,
04,
04,
04,
24,
24,
24,
24,
18,
18,
18,
18,
04,
04,
04,
04,
04,
04,
04,
04,
04,
04,
10,
10,
10,
10,
06,
06,
06,
06,
06,
04,
04,
04,
04,
04,
04,
04,
04,

2008
2008
2008
2008
2008
2008
2008
2009
2009
2009
2009
2010
2010
2010
2010
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008

EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
35MG BASE
40MG BASE
70MG BASE

N020560
N020560
N020560
N020560
N020560

003
001
004
002
005

Apr
Sep
Oct
Sep
Oct

25,
29,
20,
29,
20,

1997
1995
2000
1995
2000

ALENDRONATE SODIUM; CHOLECALCIFEROL

TABLET; ORAL
FOSAMAX PLUS D
MERCK
XX
XX +

EQ 70MG BASE;2,800 IU
EQ 70MG BASE;5,600 IU

N021762 001
N021762 002

Apr 07, 2005

Apr 26, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 14 (of 424)

ALFENTANIL HYDROCHLORIDE
INJECTABLE; INJECTION
ALFENTA
AP + AKORN
ALFENTANIL
HOSPIRA
AP

EQ 0.5MG BASE/ML

N019353 001

Dec 29, 1986

EQ 0.5MG BASE/ML

A075221 001

Oct 28, 1999

10MG
10MG
10MG
10MG
10MG

A079013
A079014
A079057
A079056
A079054

Jul
Jul
Jul
Jul
Jul

10MG

N021287 001

Jun 12, 2003

80 UNITS/ML

N020057 003

Apr 05, 1991

EQ 150MG BASE
EQ 300MG BASE

N021985 001
N021985 002

Mar 05, 2007

Mar 05, 2007

N022545
N022545
N022545
N022545

001
002
003
004

Aug
Aug
Aug
Aug

26,
26,
26,
26,

2010
2010
2010
2010

N200045
N200045
N200045
N200045
N200045

001
002
003
004
005

Dec
Dec
Dec
Dec
Dec

21,
21,
21,
21,
21,

2010
2010
2010
2010
2010

N022107
N022107
N022107
N022107

001
002
003
004

Jan
Jan
Jan
Jan

18,
18,
18,
18,

2008
2008
2008
2008

ALFUZOSIN HYDROCHLORIDE

AB
AB
AB
AB
AB
AB

TABLET, EXTENDED RELEASE;

ALFUZOSIN HYDROCHLORIDE
APOTEX INC
MYLAN
SUN PHARMA GLOBAL
TEVA PHARMS
TORRENT PHARMS
UROXATRAL
+ SANOFI AVENTIS US

ORAL
001
001
001
001
001

18,
18,
18,
18,
18,

2011
2011
2011
2011
2011

ALGLUCERASE
INJECTABLE; INJECTION

CEREDASE

XX + GENZYME

ALISKIREN HEMIFUMARATE
TABLET; ORAL

TEKTURNA

XX
NOVARTIS

XX +

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

TABLET; ORAL
TEKAMLO
NOVARTIS
XX
XX
XX
XX +

EQ
EQ
EQ
EQ

150MG
150MG
300MG
300MG

BASE;EQ
BASE;EQ
BASE;EQ
BASE;EQ

5MG BASE
10MG BASE
5MG BASE
10MG BASE

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
AMTURNIDE
NOVARTIS
XX
XX
XX
XX
XX +

EQ
EQ
EQ
EQ
EQ

150MG
300MG
300MG
300MG
300MG

BASE;EQ
BASE;EQ
BASE;EQ
BASE;EQ
BASE;EQ

5MG BASE;12.5MG
5MG BASE;12.5MG
5MG BASE;25MG
10MG BASE;12.5MG
10MG BASE;25MG

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL

TEKTURNA HCT

NOVARTIS
XX
XX
XX +
XX +

EQ
EQ
EQ
EQ

150MG
150MG
300MG
300MG

BASE;12.5MG

BASE;25MG

BASE;12.5MG
BASE;25MG

ALISKIREN HEMIFUMARATE; VALSARTAN

TABLET; ORAL

VALTURNA

NOVARTIS
XX
XX +

EQ 150MG BASE;160MG

EQ 300MG BASE;320MG

N022217 001
N022217 002

Sep 16, 2009

Sep 16, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 15 (of 424)

ALITRETINOIN
GEL; TOPICAL

PANRETIN

XX + EISAI INC

EQ 0.1% BASE

N020886 001

Feb 02, 1999

100MG
300MG
100MG
300MG
100MG
300MG
100MG
300MG
100MG
300MG
100MG
300MG
100MG
300MG
100MG
300MG

A077353
A077353
A078390
A078390
A090637
A090637
A071449
A071450
N018659
N018659
A078253
A078253
A075798
A075798
N018832
N018877

Sep
Sep
Aug
Aug
Mar
Mar
Jan
Jan
Oct
Oct
Sep
Sep
Jun
Jun
Sep
Sep

100MG
300MG

A071586 001
A071587 001

100MG
300MG

N016084 001
N016084 002

EQ 500MG BASE/VIAL

A076870 001

Aug 26, 2004

EQ 500MG BASE/VIAL

N020298 001

May 17, 1996

EQ 6.25MG BASE
EQ 12.5MG BASE

N021001 001
N021001 002

May 07, 2001

May 07, 2001

EQ 0.5MG BASE
EQ 1MG BASE

N021107 002
N021107 001

Dec 23, 2003

Feb 09, 2000

ALLOPURINOL
TABLET; ORAL
ALLOPURINOL
APOTEX INC
AB
AB
CARACO
AB
AB
IPCA LABS LTD
AB
AB
MUTUAL PHARM
AB
AB
MYLAN
AB
AB
NORTHSTAR HLTHCARE
AB
AB
VINTAGE PHARMS
AB
AB
WATSON LABS
AB
AB
LOPURIN
DR REDDYS LA
AB
AB
ZYLOPRIM
PROMETHEUS LABS
AB
AB +

001
002
001
002
001
002
001
001
001
002
001
002
001
002
002
001

08,
08,
30,
30,
16,
16,
09,
09,
24,
24,
11,
11,
27,
27,
28,
28,

2005
2005
2007
2007
2011
2011
1987
1987
1986
1986
2007
2007
2003
2003
1984
1984

Apr 02, 1987

Apr 02, 1987

ALLOPURINOL SODIUM
INJECTABLE; INJECTION
ALLOPURINOL SODIUM
BEDFORD LABS
AP
ALOPRIM
AP + MYLAN INSTITUTIONAL

ALMOTRIPTAN MALATE
TABLET; ORAL
AXERT
JANSSEN PHARMS
XX
XX +

ALOSETRON HYDROCHLORIDE
TABLET; ORAL
LOTRONEX
PROMETHEUS LABS
XX
XX +

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

XX + SANDOZ

2 IU/ML;40MG/ML;12MCG/ML;40
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

N021163 001

May 18, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 16 (of 424)

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; IV (INFUSION)

INFUVITE ADULT

XX + SANDOZ
2 IU/ML;40MG/ML;12MCG/ML;40
IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1
.2MG/ML;0.72MG/ML;1.2MG/ML;660
IU/ML;30MCG/ML

N021559 001

Jun 16, 2003

1MG/ML

A074312 001

Oct 31, 1993

0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG

A074342
A074342
A074342
A074342
A074046
A074046
A074046
A074046
A077741
A077741
A077741
A077741
A090248
A090248
A090248
A090248
A074174
A074174
A074174
A074174
A074215
A074215
A074215
A074215
A074112
A074112
A074112
A074909
A090082
A090082
A090082
A090082
A078491
A078491
A078491
A078491

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
001
001
002
003
004
001
002
003
004

Oct
Oct
Oct
Oct
Oct
Oct
Oct
May
Jan
Jan
Jan
Jan
Sep
Sep
Sep
Sep
Oct
Oct
Oct
Oct
Jan
Jan
Jan
Jan
Dec
Dec
Dec
Mar
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Dec

0.25MG
0.5MG
1MG
2MG

N018276
N018276
N018276
N018276

001
002
003
004

Nov 27, 1985

A078056 001
A078056 002

Feb 13, 2007

Feb 13, 2007

ALPRAZOLAM
CONCENTRATE; ORAL

ALPRAZOLAM

XX + ROXANE
TABLET; ORAL
ALPRAZOLAM
ACTAVIS ELIZABETH
AB
AB
AB
AB
ALPHAPHARM
AB
AB
AB
AB
APOTEX INC
AB
AB
AB
AB
BOCA PHARMA
AB
AB
AB
AB
DAVA INTL INC
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
SUN PHARMA GLOBAL
AB
AB
AB
AB
VINTAGE
AB
AB
AB
AB
XANAX
PHARMACIA AND UPJOHN
AB
AB
AB +
AB

TABLET, EXTENDED RELEASE; ORAL

ALPRAZOLAM
ACTAVIS ELIZABETH
AB
0.5MG
AB
1MG

31,
31,
31,
31,
19,
19,
19,
07,
19,
19,
19,
19,
17,
17,
17,
17,
19,
19,
19,
19,
27,
27,
27,
27,
29,
29,
29,
25,
17,
17,
17,
17,
25,
25,
25,
12,

1993
1993
1993
1993
1993
1993
1993
1997
2007
2007
2007
2007
2010
2010
2010
2010
1993
1993
1993
1993
1994
1994
1994
1994
1995
1995
1995
1998
2010
2010
2010
2010
2008
2008
2008
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 17 (of 424)

ALPRAZOLAM
TABLET, EXTENDED RELEASE; ORAL
ALPRAZOLAM
ACTAVIS ELIZABETH
AB
2MG
AB
3MG
AMNEAL PHARMS NY
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
ANCHEN PHARMS
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
APOTEX INC
AB
0.5MG
AB
2MG
AB
3MG
AUROBINDO PHARMA USA 0.5MG
AB
AB
1MG
AB
2MG
AB
3MG
BARR
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
COREPHARMA
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
IMPAX LABS
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
MYLAN
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
SANDOZ
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
TEVA PHARMS
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
VINTAGE
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
WATSON LABS FLORIDA
AB
0.5MG
AB
1MG
AB
2MG
AB
3MG
ZYDUS PHARMS USA INC 0.5MG
AB
AB
1MG
AB
2MG
AB
3MG
XANAX XR
PHARMACIA AND UPJOHN 0.5MG
AB
AB
1MG
AB
2MG

A078056
A078056
A078387
A078387
A078387
A078387
A078469
A078469
A078469
A078469
A078449
A078449
A078449
A090871
A090871
A090871
A090871
A077725
A077725
A077725
A077725
A077996
A077996
A077996
A077996
A077968
A077968
A077968
A077968
A077391
A077391
A077391
A077391
A077777
A077777
A077777
A077777
A077979
A077979
A077979
A077979
A078442
A078442
A078442
A078442
A077198
A077198
A077198
A077198
A078489
A078489
A078489
A078489

003
004
001
002
003
004
001
002
003
004
001
002
003
001
002
003
004
001
002
004
003
001
002
003
004
004
003
002
001
002
003
004
001
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

N021434 001
N021434 002
N021434 003

Feb
Feb
May
May
May
May
Sep
Sep
Sep
Sep
Nov
Nov
Nov
Jun
Jun
Jun
Jun
Jul
Jul
Jul
Jul
Jan
Jan
Jan
Jan
May
May
May
May
Jan
Jan
Jan
Jan
Jun
Jun
Jun
Jun
Feb
Feb
Feb
Feb
Oct
Oct
Oct
Oct
May
May
May
May
Oct
Oct
Oct
Oct

13,
13,
30,
30,
30,
30,
29,
29,
29,
29,
12,
12,
12,
07,
07,
07,
07,
31,
31,
31,
31,
31,
31,
31,
31,
24,
24,
24,
24,
26,
26,
26,
26,
30,
30,
30,
30,
28,
28,
28,
28,
15,
15,
15,
15,
13,
13,
13,
13,
17,
17,
17,
17,

2007
2007
2008
2008
2008
2008
2011
2011
2011
2011
2008
2008
2008
2011
2011
2011
2011
2006
2006
2006
2006
2007
2007
2007
2007
2007
2007
2007
2007
2006
2006
2006
2006
2006
2006
2006
2006
2007
2007
2007
2007
2007
2007
2007
2007
2010
2010
2010
2010
2008
2008
2008
2008

Jan 17, 2003

Jan 17, 2003
Jan 17, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 18 (of 424)

ALPRAZOLAM
TABLET, EXTENDED RELEASE; ORAL
XANAX XR
AB + PHARMACIA AND UPJOHN 3MG

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET, ORALLY DISINTEGRATING; ORAL

ALPRAZOLAM
ACTAVIS ELIZABETH
0.25MG
0.5MG
1MG
2MG
PAR PHARM
0.25MG
0.5MG
1MG
2MG
NIRAVAM
SCHWARZ PHARMA
0.25MG
0.5MG
+
1MG
2MG

N021434 004

Jan 17, 2003

A078561
A078561
A078561
A078561
A078088
A078088
A078088
A078088

001
002
003
004
001
002
003
004

Mar
Mar
Mar
Mar
Jan
Jan
Jan
Jan

16,
16,
16,
16,
09,
09,
09,
09,

2010
2010
2010
2010
2009
2009
2009
2009

N021726
N021726
N021726
N021726

001
002
003
004

Jan
Jan
Jan
Jan

19,
19,
19,
19,

2005
2005
2005
2005

ALPROSTADIL

AP
AP
AP
AP
AP
AP
AP
AP
AP
XX
XX
XX
XX
XX
XX

INJECTABLE; INJECTION
ALPROSTADIL
BEDFORD
TEVA PARENTERAL
CAVERJECT
PHARMACIA AND UPJOHN
+
+
EDEX
SCHWARZ PHARMA
+
PROSTIN VR PEDIATRIC
+ PHARMACIA AND UPJOHN
CAVERJECT
PHARMACIA AND UPJOHN
CAVERJECT IMPULSE
PHARMACIA AND UPJOHN
EDEX
+ SCHWARZ PHARMA
+
+

SUPPOSITORY; URETHRAL
MUSE
MEDA PHARMS
XX
XX
XX
XX +

0.5MG/ML
0.5MG/ML

A074815 001
A075196 001

Jan 20, 1998

Apr 30, 1999

0.01MG/VIAL
0.02MG/VIAL
0.04MG/VIAL

N020379 001
N020379 002
N020379 004

Jul 06, 1995

Jul 06, 1995
May 19, 1997

0.01MG/VIAL
0.02MG/VIAL
0.04MG/VIAL

N020649 002
N020649 003
N020649 004

Jun 12, 1997

Jun 12, 1997
Jun 12, 1997

0.5MG/ML

N018484 001

0.005MG/VIAL

N020379 003

Jun 27, 1996

0.01MG/VIAL
0.02MG/VIAL

N021212 001
N021212 002

Jun 11, 2002

Jun 11, 2002

0.01MG/VIAL
0.02MG/VIAL
0.04MG/VIAL

N020649 005
N020649 006
N020649 007

Jul 30, 1998

Jul 30, 1998
Jul 30, 1998

0.125MG
0.25MG
0.5MG
1MG

N020700
N020700
N020700
N020700

Nov
Nov
Nov
Nov

50MG

N019926 001

Dec 26, 1990

12MG

N021775 001

May 20, 2008

001
002
003
004

19,
19,
19,
19,

1996
1996
1996
1996

ALTRETAMINE
CAPSULE; ORAL

HEXALEN

XX + EISAI INC

ALVIMOPAN
CAPSULE; ORAL

ENTEREG

XX + ADOLOR

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 19 (of 424)

AMANTADINE HYDROCHLORIDE
CAPSULE; ORAL
AMANTADINE HYDROCHLORIDE
BANNER PHARMACAPS
AB
100MG
SANDOZ
AB
100MG
AB + USL PHARMA
100MG

AA
AA
AA
AA
AA
AA
AA

SYRUP; ORAL
AMANTADINE HYDROCHLORIDE
+ CAROLINA MEDCL
50MG/5ML
+ HI TECH PHARMA
50MG/5ML
+ MIKART
50MG/5ML
+ PHARM ASSOC
50MG/5ML
+ SILARX
50MG/5ML
+ VINTAGE
50MG/5ML
+ WOCKHARDT
50MG/5ML

TABLET; ORAL

AMANTADINE HYDROCHLORIDE

100MG
XX + USL PHARMA

A078720 001
A071293 001
A070589 001

May 29, 2008

Feb 18, 1987
Aug 05, 1986

A075819
A074170
A074028
A074509
A076352
A077992
A075060

Sep
Oct
Jun
Jul
Sep
Dec
Dec

001
001
001
001
001
001
001

A076186 001

11,
28,
28,
17,
10,
12,
24,

2002
1994
1993
1995
2004
2006
1998

Dec 16, 2002

AMBENONIUM CHLORIDE
TABLET; ORAL

MYTELASE

XX + SANOFI AVENTIS US

10MG

N010155 002

5MG
10MG

N022081 001
N022081 002

Jun 15, 2007

Jun 15, 2007

CREAM; TOPICAL
AMCINONIDE
AB + ALTANA
TARO PHARM INDS
AB

0.1%
0.1%

A076065 001
A076229 001

May 15, 2003

May 31, 2002

LOTION; TOPICAL

AMCINONIDE

XX + ALTANA

0.1%

A076329 001

Nov 06, 2002

OINTMENT; TOPICAL
AMCINONIDE
AB + ALTANA
TARO PHARM INDS
AB

0.1%
0.1%

A076096 001
A076367 001

Nov 19, 2002

Mar 19, 2003

500MG/VIAL

A077126 001

Mar 14, 2008

500MG/VIAL

N020221 001

Dec 08, 1995

EQ
EQ
EQ
EQ
EQ

A063313
A063315
A063263
A063264
A064045

Apr
Apr
Nov
Nov
Sep

AMBRISENTAN
TABLET; ORAL
LETAIRIS
GILEAD
XX
XX +

AMCINONIDE

AMIFOSTINE
INJECTABLE; INJECTION
AMIFOSTINE
SUN PHARMA GLOBAL
AP
ETHYOL
AP + MEDIMMUNE

AMIKACIN SULFATE
INJECTABLE; INJECTION
AMIKACIN SULFATE
AP + BEDFORD
AP +
HOSPIRA
AP
AP
TEVA PARENTERAL
AP

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

001
001
001
001
002

11,
11,
30,
30,
28,

1994
1994
1994
1994
1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 20 (of 424)

AMILORIDE HYDROCHLORIDE
TABLET; ORAL
AMILORIDE HYDROCHLORIDE
5MG
AB + PAR PHARM
SIGMAPHARM LABS LLC
5MG
AB
MIDAMOR
PADDOCK LLC
AB
5MG

A070346 001
A079133 001

Jan 22, 1986

Jan 30, 2009

N018200 001

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
BARR
AB
EQ 5MG ANHYDROUS;50MG
AB + MYLAN
EQ 5MG ANHYDROUS;50MG

A071111 001

A073209 001

May 10, 1988

Oct 31, 1991

AMINO ACIDS

XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX

INJECTABLE; INJECTION
AMINOSYN 10%
HOSPIRA
10% (10GM/100ML)
AMINOSYN 10% (PH6)
HOSPIRA
10% (10GM/100ML)
AMINOSYN 3.5%
HOSPIRA
3.5% (3.5GM/100ML)
AMINOSYN 5%
HOSPIRA
5% (5GM/100ML)
AMINOSYN 7%
HOSPIRA
7% (7GM/100ML)
AMINOSYN 7% (PH6)
HOSPIRA
7% (7GM/100ML)
AMINOSYN 8.5%
HOSPIRA
8.5% (8.5GM/100ML)
AMINOSYN 8.5% (PH6)
HOSPIRA
8.5% (8.5GM/100ML)
AMINOSYN II 10%
HOSPIRA
10% (10GM/100ML)
AMINOSYN II 10% IN PLASTIC CONTAINER
HOSPIRA
10% (10GM/100ML)
AMINOSYN II 15% IN PLASTIC CONTAINER
HOSPIRA
15% (15GM/100ML)
AMINOSYN II 7%
HOSPIRA
7% (7GM/100ML)
AMINOSYN II 8.5%
HOSPIRA
8.5% (8.5GM/100ML)
AMINOSYN-HBC 7%
HOSPIRA
7% (7GM/100ML)
AMINOSYN-HF 8%
HOSPIRA
8% (8GM/100ML)
AMINOSYN-PF 10%
HOSPIRA
10% (10GM/100ML)
AMINOSYN-PF 7%
HOSPIRA
7% (7GM/100ML)
AMINOSYN-RF 5.2%
HOSPIRA
5.2% (5.2GM/100ML)
BRANCHAMIN 4% IN PLASTIC CONTAINER
BAXTER HLTHCARE
4% (4GM/100ML)
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER
CLINTEC NUTR
15% (15GM/100ML)
FREAMINE HBC 6.9%
B BRAUN
6.9% (6.9GM/100ML)
FREAMINE III 10%
B BRAUN
10% (10GM/100ML)

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

N020345 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

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 21 (of 424)

AMINO ACIDS

XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX

INJECTABLE; INJECTION
FREAMINE III 8.5%
B BRAUN
8.5% (8.5GM/100ML)
HEPATAMINE 8%
B BRAUN
8% (8GM/100ML)
HEPATASOL 8%
BAXTER HLTHCARE
8% (8GM/100ML)
NEPHRAMINE 5.4%
B BRAUN
5.4% (5.4GM/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)
TRAVASOL 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE
10% (10MG/100ML)
TRAVASOL 10% W/O ELECTROLYTES
BAXTER HLTHCARE
10% (10GM/100ML)
TRAVASOL 5.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5.5% (5.5GM/100ML)
TRAVASOL 5.5% W/O ELECTROLYTES
BAXTER HLTHCARE
5.5% (5.5GM/100ML)
TRAVASOL 8.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
8.5% (8.5GM/100ML)
TRAVASOL 8.5% W/O ELECTROLYTES
BAXTER HLTHCARE
8.5% (8.5GM/100ML)

TROPHAMINE

+ B BRAUN
6% (6GM/100ML)
TROPHAMINE 10%
+ B BRAUN
10% (10GM/100ML)

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

N018931 003

Aug 23, 1984

N017493 006
N018931 001

Aug 23, 1984

N017493 004
N018931 002

Aug 23, 1984

N017493 005

N019018 001

Jul 20, 1984

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
XX

3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG
/100ML;150MG/100ML;200MG/100ML;120MG/10
0ML

N018582 001

May 08, 1982

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE,

DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

XX

XX

XX

XX

XX

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

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 22 (of 424)

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE,

DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

XX

XX

XX

XX

XX

XX

XX

INJECTABLE; INJECTION
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

XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX

INJECTABLE; INJECTION
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE
2.75%;10GM/100ML
N020734
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE
2.75%;25GM/100ML
N020734
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
2.75%;5GM/100ML
N020734
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE
4.25%;10GM/100ML
N020734
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE
4.25%;20GM/100ML
N020734
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
N020734
BAXTER HLTHCARE
4.25%;25GM/100ML
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
N020734
BAXTER HLTHCARE
4.25%;5GM/100ML
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
N020734
BAXTER HLTHCARE
5%;10GM/100ML
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER
N020734
BAXTER HLTHCARE
5%;15GM/100ML
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
N020734
BAXTER HLTHCARE
5%;20GM/100ML
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5%;25GM/100ML
N020734
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5%;35GM/100ML
N020734

002

Sep 29, 1997

005

Sep 29, 1997

001

Sep 29, 1997

008

Sep 29, 1997

010

Sep 29, 1997

011

Sep 29, 1997

007

Sep 29, 1997

014

Sep 29, 1997

015

Sep 29, 1997

016

Sep 29, 1997

017

Sep 29, 1997

018

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
XX
;440MG/100ML;690MG/100ML

N016822 007

Jul 01, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 23 (of 424)

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE; INJECTION

AMINOSYN 3.5% M

HOSPIRA
XX

3.5%;21MG/100ML;40MG/100ML;128MG/100ML;
234MG/100ML

N017789 003

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
XX
0MG/100ML;120MG/100ML

N016822 003

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;
XX
410MG/100ML
AMINOSYN II 8.5% W/ ELECTROLYTES
HOSPIRA
8.5%;102MG/100ML;45MG/100ML;522MG/100ML
XX
;410MG/100ML

N019437 004

Apr 03, 1986

N019437 005

Apr 03, 1986

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
XX
;35MG/100ML
TRAVASOL 3.5% W/ ELECTROLYTES
BAXTER HLTHCARE
3.5%;51MG/100ML;131MG/100ML;218MG/100ML
XX
;35MG/100ML
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
BAXTER HLTHCARE
5.5%;102MG/100ML;522MG/100ML;431MG/100M
XX
L;224MG/100ML
TRAVASOL 5.5% W/ ELECTROLYTES
BAXTER HLTHCARE
5.5%;102MG/100ML;522MG/100ML;431MG/100M
XX
L;224MG/100ML
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
XX
BAXTER HLTHCARE
8.5%;102MG/100ML;522MG/100ML;594MG/100M
L;154MG/100ML
TRAVASOL 8.5% W/ ELECTROLYTES
XX
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
XX
AMINOSYN 8.5% W/ ELECTROLYTES

HOSPIRA
8.5%;102MG/100ML;522MG/100ML;410MG/100M
XX
L

N017789 002

N017673 005

AMINOCAPROIC ACID
INJECTABLE; INJECTION
AMINOCAPROIC ACID
LUITPOLD
AP
250MG/ML
AMINOCAPROIC ACID IN PLASTIC CONTAINER
AP + HOSPIRA
250MG/ML

A071192 001

Dec 01, 1987

A070010 001

Mar 09, 1987

SYRUP; ORAL
AMICAR
AA + XANODYNE PHARM

N015230 002

1.25GM/5ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 24 (of 424)

AMINOCAPROIC ACID
SYRUP; ORAL
AMINOCAPROIC ACID
MIKART
AA
TABLET; ORAL
AMICAR
XANODYNE PHARM
AB
AMINOCAPROIC
MIKART
AB
AMICAR
XX + XANODYNE PHARM

Sep 02, 1998

1.25GM/5ML

A074759 001

500MG

N015197 001

500MG

A075602 001

May 24, 2001

1GM

N015197 002

Jun 24, 2004

20%

N005619 001

AMINOHIPPURATE SODIUM
INJECTABLE; INJECTION

AMINOHIPPURATE SODIUM

XX + MERCK

AMINOLEVULINIC ACID HYDROCHLORIDE

SOLUTION; TOPICAL

LEVULAN

XX + DUSA

20%

N020965 001

Dec 03, 1999

25MG/ML
25MG/ML
25MG/ML
25MG/ML

A087242
A087209
A087600
A087392

Oct 26, 1983

Feb 01, 1982

100MG
200MG

A084540 001
A085003 001

AMINOPHYLLINE

AP
AP
AP
AP

INJECTABLE; INJECTION
AMINOPHYLLINE
+ HOSPIRA
INTL MEDICATION
LUITPOLD
PHARMA SERVE NY

TABLET; ORAL

AMINOPHYLLINE

XX + WEST WARD
XX +

001
001
001
001

Dec 15, 1983

AMINOSALICYLIC ACID
GRANULE, DELAYED RELEASE; ORAL

PASER

4GM/PACKET
XX + JACOBUS

A074346 001

Jun 30, 1994

A076232
A075761
A076018
A076299
A076217
A076394
A077161
A077234
A075955
A076163
A077610
A077834

Jul
Oct
Oct
Oct
Oct
Apr
Apr
Feb
Oct
Sep
Oct
Oct

AMIODARONE HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
XX
XX

INJECTABLE; INJECTION
AMIODARONE HYDROCHLORIDE
+ AKORN
50MG/ML
+ APP PHARMS
50MG/ML
+ BEDFORD
50MG/ML
+ BEDFORD LABS
50MG/ML
+ BIONICHE PHARMA
50MG/ML
+ CLARIS LIFESCIENCES
50MG/ML
+ GLAND PHARMA LTD
50MG/ML
HIKMA FARMACEUTICA
50MG/ML
+ HOSPIRA
50MG/ML
+ TEVA PARENTERAL
50MG/ML
WOCKHARDT
50MG/ML
50MG/ML
NEXTERONE
BAXTER HLTHCARE
50MG/ML
NEXTERONE
+ BAXTER HLTHCARE
150MG/100ML (1.5MG/ML)
+
360MG/200ML (1.8MG/ML)

001
001
001
001
001
001
001
001
001
001
001
001

05,
15,
15,
24,
15,
25,
20,
25,
18,
05,
30,
30,

2006
2002
2002
2002
2002
2003
2005
2008
2002
2003
2008
2008

N022325 001

Dec 24, 2008

N022325 002
N022325 003

Nov 16, 2010

Nov 16, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 25 (of 424)

AMIODARONE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
XX

TABLET; ORAL
AMIODARONE HYDROCHLORIDE
APOTEX CORP
200MG
AUROSAL PHARMS
200MG
400MG
BARR
200MG
MYLAN
200MG
SANDOZ
200MG
400MG
TARO
100MG
200MG
400MG
TEVA PHARMS
200MG
ZYDUS PHARMS USA INC 200MG
CORDARONE
+ WYETH PHARMS INC
200MG
PACERONE
UPSHER SMITH
100MG
200MG
AMIODARONE HYDROCHLORIDE
TARO
300MG

A078578
A077069
A077069
A075389
A075188
A075315
A075315
A075424
A075424
A076362
A074739
A079029

001
001
002
001
001
001
002
002
001
001
001
001

Nov
Apr
Apr
Jan
Feb
Dec
Jun
Dec
Mar
Nov
Nov
Sep

06,
08,
08,
25,
24,
23,
30,
18,
30,
29,
30,
16,

2008
2005
2005
2001
1999
1998
2000
2002
2001
2002
1998
2008

N018972 001

Dec 24, 1985

A075135 002
A075135 001

Apr 12, 2005

Apr 30, 1998

A076362 002

Dec 02, 2003

A040815
A040816
A040817
A040818
A040819
A040820
A089398
A089399
A089400
A089401
A089402
A089403
A086009
A086009
A086009
A086009
A086009
A086009
A085969
A085966
A085968
A085971
A085967
A085970
A040218
A040218
A040218
A040218
A040218
A040218

Jun
Jun
Jun
Jun
Jun
Jun
Jul
Jul
Jul
Jul
Jul
Jul

27,
27,
27,
27,
27,
27,
14,
14,
14,
14,
14,
14,

2008
2008
2008
2008
2008
2008
1987
1987
1987
1987
1987
1987

Sep
Sep
Sep
Sep
Sep
Sep

11,
11,
11,
11,
11,
11,

1997
1997
1997
1997
1997
1997

AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL
AMITRIPTYLINE HYDROCHLORIDE
CARACO
AB
10MG
AB
25MG
AB
50MG
AB
75MG
AB
100MG
AB
150MG
MUTUAL PHARM
AB
10MG
AB
25MG
AB
50MG
AB
75MG
AB
100MG
AB
150MG
MYLAN
AB
10MG
AB
25MG
AB
50MG
AB
75MG
AB
100MG
AB
150MG
SANDOZ
AB
10MG
AB +
25MG
AB
50MG
AB
75MG
AB
100MG
AB
150MG
VINTAGE PHARMS
AB
10MG
AB
25MG
AB
50MG
AB
75MG
AB
100MG
AB
150MG

001
001
001
001
001
001
001
001
001
001
001
001
002
003
001
004
005
006
001
001
001
001
001
001
001
002
003
004
005
006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 26 (of 424)

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

TABLET; ORAL
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
MYLAN
AB
EQ 12.5MG BASE;5MG
AB
EQ 25MG BASE;10MG
LIMBITROL
VALEANT PHARM INTL
AB
EQ 12.5MG BASE;5MG
LIMBITROL DS
AB + VALEANT PHARM INTL
EQ 25MG BASE;10MG

A071297 002
A071297 001

Dec 10, 1986

Dec 10, 1986

N016949 001
N016949 002

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

TABLET; ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
MYLAN
10MG;2MG
XX
10MG;4MG
XX
25MG;2MG
XX +
25MG;4MG
XX +
50MG;4MG
XX +

A071443
A071443
A071443
A071443
A071443

002
003
004
005
001

Nov
Nov
Nov
Nov
Nov

10,
10,
10,
10,
10,

1988
1988
1988
1988
1988

AMLEXANOX
PASTE; DENTAL

APHTHASOL

XX + ULURU

5%

N020511 001

Dec 17, 1996

A078925
A078925
A078925
A078477
A078477
A078477
A076719
A076719
A076719
A078021
A078021
A078021
A078231
A078231
A078231
A076692
A076692
A076692
A078552
A078552
A078552
A077771
A077771
A077771
A077955
A077955
A077955
A076859
A076859
A076859
A078043
A078043
A078043

May
May
May
Jan
Jan
Jan
May
May
May
Jul
Jul
Jul
Nov
Nov
Nov
Jul
Jul
Jul
Apr
Apr
Apr
Apr
Apr
Apr
Aug
Aug
Aug
Sep
Sep
Sep
Jul
Jul
Jul

AMLODIPINE BESYLATE
TABLET; ORAL
AMLODIPINE BESYLATE
ALKEM
AB
AB
AB
AMNEAL PHARMS NY
AB
AB
AB
APOTEX
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
CARACO
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
LEK PHARMS DD
AB
AB
AB
LUPIN
AB
AB
AB

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

04,
04,
04,
16,
16,
16,
23,
23,
23,
17,
17,
17,
30,
30,
30,
20,
20,
20,
08,
08,
08,
12,
12,
12,
28,
28,
28,
10,
10,
10,
12,
12,
12,

2009
2009
2009
2008
2008
2008
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2009
2009
2009
2011
2011
2011
2007
2007
2007
2007
2007
2007
2007
2007
2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 27 (of 424)

AMLODIPINE BESYLATE
TABLET; ORAL
AMLODIPINE BESYLATE
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
UPSHER SMITH
AB
AB
AB
VINTAGE
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
AB
AB
WOCKHARDT
AB
AB
AB
WORLD GEN
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB
NORVASC
PFIZER
AB
AB
AB +

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
2.5MG BASE
5MG BASE
5MG BASE
10MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE

EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE

A078224
A078224
A078224
A076418
A076418
A076418
A078453
A078453
A078453
A078131
A078131
A078131
A077974
A077974
A077974
A077262
A077262
A077262
A090752
A090752
A076846
A076846
A076846
A078573
A078573
A078573
A077759
A077759
A077759
A078414
A078414
A078414
A077073
A077671
A077073
A077671
A077073
A077671
A078500
A078500
A078500
A077516
A077516
A077516
A078226
A078226
A078226

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003
001
002
003

Feb
Feb
Feb
Oct
Oct
Oct
Jul
Jul
Jul
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul
Apr
Apr
Jun
Jun
Jun
Sep
Sep
Sep
Jul
Jul
Jul
Apr
Apr
Apr
Sep
Jul
Sep
Jul
Sep
Jul
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul

27,
27,
27,
03,
03,
03,
02,
02,
02,
04,
04,
04,
09,
09,
09,
09,
09,
09,
15,
15,
28,
28,
28,
22,
22,
22,
09,
09,
09,
07,
07,
07,
26,
19,
26,
19,
26,
19,
06,
06,
06,
11,
11,
11,
09,
09,
09,

2008
2008
2008
2005
2005
2005
2009
2009
2009
2007
2007
2007
2007
2007
2007
2007
2007
2007
2011
2011
2007
2007
2007
2008
2008
2008
2007
2007
2007
2010
2010
2010
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007

N019787 001
N019787 002
N019787 003

Jul 31, 1992

Jul 31, 1992
Jul 31, 1992

N021540 009
N021540 010

Jul 29, 2004

Jul 29, 2004

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

TABLET; ORAL

CADUET

PFIZER
XX
XX

EQ 2.5MG BASE;EQ 10MG BASE

EQ 2.5MG BASE;EQ 20MG BASE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 28 (of 424)

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

TABLET; ORAL
CADUET
PFIZER
XX
XX
XX
XX
XX
XX
XX
XX
XX +

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

2.5MG BASE;EQ 40MG BASE

5MG BASE;EQ 10MG BASE
5MG BASE;EQ 20MG BASE
5MG BASE;EQ 40MG BASE
5MG BASE;EQ 80MG BASE
10MG BASE;EQ 10MG BASE
10MG BASE;EQ 20MG BASE
10MG BASE;EQ 40MG BASE
10MG BASE;EQ 80MG BASE

N021540
N021540
N021540
N021540
N021540
N021540
N021540
N021540
N021540

011
001
002
003
004
005
006
007
008

Jul
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan

29,
30,
30,
30,
30,
30,
30,
30,
30,

2004
2004
2004
2004
2004
2004
2004
2004
2004

A077183
A077183
A077183
A090149
A077183
A090149
A078466
A078466
A078466
A078466
A078466
A078466
A077375
A077375
A077375
A079047
A077375
A079047
A078381
A078381
A078381
A078381
A078381
A078381
A077179
A077179
A077179
A077179
A077179
A077179
A077890
A077890
A077890
A077890
A090364
A090364

001
002
003
001
004
002
001
002
003
005
004
006
001
002
003
001
004
002
001
002
003
005
004
006
001
002
003
005
004
006
001
002
003
004
001
002

Apr
Apr
Apr
Jul
Apr
Jul
Feb
Feb
Feb
Jul
Feb
Jul
May
May
May
Jul
May
Jul
Jul
Jul
Jul
Jul
Jul
Jul
May
May
May
Jul
May
Jul
Oct
Oct
Oct
Oct
Jul
Jul

15,
15,
15,
05,
15,
05,
05,
05,
05,
05,
05,
05,
21,
21,
21,
05,
21,
05,
29,
29,
29,
29,
29,
29,
18,
18,
18,
05,
18,
05,
14,
14,
14,
14,
05,
05,

2010
2010
2010
2011
2010
2011
2010
2010
2010
2011
2010
2011
2010
2010
2010
2011
2010
2011
2010
2010
2010
2010
2010
2010
2007
2007
2007
2011
2007
2011
2010
2010
2010
2010
2011
2011

N020364
N020364
N020364
N020364
N020364
N020364

002
003
004
007
005
006

Mar
Mar
Mar
Apr
Jun
Apr

03,
03,
03,
11,
20,
11,

1995
1995
1995
2006
2002
2006

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

CAPSULE; ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
DR REDDYS LABS INC
AB
EQ 2.5MG BASE;10MG
AB
EQ 5MG BASE;10MG
AB
EQ 5MG BASE;20MG
AB
EQ 5MG BASE;40MG
AB
EQ 10MG BASE;20MG
AB
EQ 10MG BASE;40MG
LUPIN PHARMS
AB
EQ 2.5MG BASE;10MG
AB
EQ 5MG BASE;10MG
AB
EQ 5MG BASE;20MG
AB
EQ 5MG BASE;40MG
AB
EQ 10MG BASE;20MG
AB
EQ 10MG BASE;40MG
MYLAN
AB
EQ 2.5MG BASE;10MG
AB
EQ 5MG BASE;10MG
AB
EQ 5MG BASE;20MG
AB
EQ 5MG BASE;40MG
AB
EQ 10MG BASE;20MG
AB
EQ 10MG BASE;40MG
PAR PHARM
AB
EQ 2.5MG BASE;10MG
AB
EQ 5MG BASE;10MG
AB
EQ 5MG BASE;20MG
AB
EQ 5MG BASE;40MG
AB
EQ 10MG BASE;20MG
AB
EQ 10MG BASE;40MG
TEVA PHARMS
AB
EQ 2.5MG BASE;10MG
AB
EQ 5MG BASE;10MG
AB
EQ 5MG BASE;20MG
AB
EQ 5MG BASE;40MG
AB
EQ 10MG BASE;20MG
AB
EQ 10MG BASE;40MG
WATSON LABS
AB
EQ 2.5MG BASE;10MG
AB
EQ 5MG BASE;10MG
AB
EQ 5MG BASE;20MG
AB
EQ 10MG BASE;20MG
WATSON LABS INC
AB
EQ 5MG BASE;40MG
AB
EQ 10MG BASE;40MG
LOTREL
NOVARTIS
AB
EQ 2.5MG BASE;10MG
AB
EQ 5MG BASE;10MG
AB
EQ 5MG BASE;20MG
AB
EQ 5MG BASE;40MG
AB
EQ 10MG BASE;20MG
AB +
EQ 10MG BASE;40MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 29 (of 424)

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

TABLET; ORAL

TRIBENZOR

DAIICHI SANKYO
XX
XX
XX
XX
XX +

EQ
EQ
EQ
EQ
EQ

5MG BASE;12.5MG;20MG

5MG BASE;12.5MG;40MG

5MG BASE;25MG;40MG

10MG BASE;12.5MG;40MG

10MG BASE;25MG;40MG

N200175
N200175
N200175
N200175
N200175

001
002
003
004
005

Jul
Jul
Jul
Jul
Jul

23,
23,
23,
23,
23,

2010
2010
2010
2010
2010

N022314
N022314
N022314
N022314
N022314

001
002
003
004
005

Apr
Apr
Apr
Apr
Apr

30,
30,
30,
30,
30,

2009
2009
2009
2009
2009

N022100
N022100
N022100
N022100

001
002
003
004

Sep
Sep
Sep
Sep

26,
26,
26,
26,

2007
2007
2007
2007

N022401
N022401
N022401
N022401

001
003
002
004

Oct
Oct
Oct
Oct

16,
16,
16,
16,

2009
2009
2009
2009

N021990
N021990
N021990
N021990

002
004
003
005

Jun
Jun
Jun
Jun

20,
20,
20,
20,

2007
2007
2007
2007

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

TABLET; ORAL

EXFORGE HCT

NOVARTIS
XX
XX
XX
XX
XX +

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
XX
XX
XX
XX +

EQ
EQ
EQ
EQ

5MG BASE;20MG

5MG BASE;40MG

10MG BASE;20MG

10MG BASE;40MG

AMLODIPINE BESYLATE; TELMISARTAN

TABLET; ORAL

TWYNSTA

BOEHRINGER INGELHEIM
XX
XX
XX
XX +

EQ
EQ
EQ
EQ

5MG BASE;40MG

5MG BASE;80MG

10MG BASE;40MG

10MG BASE;80MG

AMLODIPINE BESYLATE; VALSARTAN

TABLET; ORAL

EXFORGE

NOVARTIS

XX
XX
XX +
XX +

EQ
EQ
EQ
EQ

5MG BASE;160MG
5MG BASE;320MG
10MG BASE;160MG
10MG BASE;320MG

AMMONIA, N-13

INJECTABLE; INTRAVENOUS

AMMONIA N 13

XX + FEINSTEIN

30MCI-300MCI/8ML (3.75-37.5MCI/ML)

N022119 001

Aug 23, 2007

A088366 001

Jun 13, 1984

A076829 001
A075774 001
A075883 001

Feb 07, 2006

May 01, 2002
Apr 10, 2003

AMMONIUM CHLORIDE
INJECTABLE; INJECTION

AMMONIUM CHLORIDE IN PLASTIC CONTAINER

5MEQ/ML
XX + HOSPIRA

AMMONIUM LACTATE
CREAM; TOPICAL
AMMONIUM LACTATE
PADDOCK LLC
AB
PERRIGO NEW YORK
AB
TARO
AB

EQ 12% BASE
EQ 12% BASE
EQ 12% BASE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 30 (of 424)

AMMONIUM LACTATE
CREAM; TOPICAL
LAC-HYDRIN
AB + RANBAXY

AB
AB
AB
AB

LOTION; TOPICAL
AMMONIUM LACTATE
PADDOCK LLC
PERRIGO NEW YORK
TARO
LAC-HYDRIN
+ RANBAXY

EQ 12% BASE

N020508 001

Aug 29, 1996

EQ 12% BASE
EQ 12% BASE
EQ 12% BASE

A075575 001
A075570 001
A076216 001

Jun 11, 2002

Jun 23, 2004
May 28, 2004

EQ 12% BASE

N019155 001

Apr 24, 1985

25MG
50MG
100MG
150MG

A072688
A072689
A072690
A072691

001
001
001
001

Aug
Aug
Aug
Aug

28,
28,
28,
28,

1992
1992
1992
1992

001
002
001
002
001
001
001
002
001
002
001
002
001
003

Nov
Nov
Feb
Feb
Feb
Feb
Apr
Apr
Sep
Sep

09,
09,
25,
25,
05,
05,
08,
08,
30,
30,

2005
2005
1988
1988
2007
2007
1999
1999
1994
1994

Dec
Dec
Nov
Nov
Jun
Jun
Jun
Jun
Nov
Nov
Mar
Mar
Mar
Mar

28,
28,
25,
25,
19,
19,
19,
19,
29,
29,
26,
26,
26,
26,

2006
2006
1988
1988
2006
2006
2006
2006
2002
2002
2007
2007
2007
2007

AMOXAPINE
TABLET; ORAL
AMOXAPINE
WATSON LABS
XX
XX
XX
XX +

AMOXICILLIN
CAPSULE; ORAL
AMOXICILLIN
AM ANTIBIOTICS
AB
AB
AUROBINDO
AB
AB
DAVA PHARMS INC
AB
AB
HIKMA PHARMS
AB
AB
RANBAXY
AB
AB
SANDOZ
AB
AB
TEVA
AB
AB +
AMOXIL
DR REDDYS LABS INC
AB
AB

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

A062058
A062058
A065271
A065271
A062884
A062881
A065291
A065291
A065016
A065016
A064076
A064076
A061926
A061926

250MG
500MG

A062216 001
A062216 004

FOR SUSPENSION; ORAL

AMOXICILLIN
AUROBINDO
AB
AB
DAVA PHARMS INC
AB
AB
HIKMA
AB
AB
AB
AB
RANBAXY
AB
AB
SANDOZ
AB
AB
AB
AB
TEVA
AB
AB
AB +
AB +

200MG/5ML
400MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
200MG/5ML
250MG/5ML
400MG/5ML
200MG/5ML
400MG/5ML
125MG/5ML
200MG/5ML
250MG/5ML
400MG/5ML
125MG/5ML
200MG/5ML
250MG/5ML
400MG/5ML

A065334
A065334
A062927
A062927
A065322
A065325
A065322
A065325
A065113
A065113
A065387
A065378
A065387
A065378
A061931
A065119
A061931
A065119

001
002
001
002
002
002
001
001
001
002
001
001
002
002
001
001
002
002

Dec 04, 2002

Dec 04, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 31 (of 424)

AMOXICILLIN
FOR SUSPENSION; ORAL
AMOXICILLIN
WOCKHARDT
AB
AMOXICILLIN PEDIATRIC
TEVA
AB
AMOXIL
DR REDDYS LABS INC
AB
AB
AB
AB
AB
LAROTID
DR REDDYS LABS INC
AB
AB

400MG/5ML

A065319 002

Jun 18, 2007

50MG/ML

A061931 003

Dec 01, 1982

50MG/ML
125MG/5ML
200MG/5ML
250MG/5ML
400MG/5ML

A062226
A062226
N050760
A062226
N050760

Apr 15, 1999

125MG/5ML
250MG/5ML

A062226 003
A062226 004

500MG
875MG
875MG
875MG
500MG
875MG
500MG
875MG
500MG
875MG

A065256
A065256
A065344
A065255
A065059
A065059
A065228
A065228
A065056
A065056

500MG
875MG

N050754 002
N050754 001

Jul 10, 1998

Jul 10, 1998

125MG
250MG
125MG
250MG
125MG
250MG

A064139
A064139
A065021
A065021
A064013
A064013

001
002
001
002
002
001

Jan
Jan
Dec
Dec
Sep
Dec

125MG
200MG
250MG
400MG

N050542
N050761
N050542
N050761

002
001
001
002

200MG
400MG

A065060 001
A065060 002

Nov 29, 2000

Nov 29, 2000

TABLET, EXTENDED RELEASE; ORAL

MOXATAG

775MG
XX + SHIONOGI INC

N050813 001

Jan 23, 2008

A065324 001
A065324 002

Jan 17, 2007

Jan 17, 2007

A065159 001

Dec 04, 2003

TABLET; ORAL
AMOXICILLIN
AUROBINDO
AB
AB
DAVA PHARMS INC
AB
HIKMA
AB
RANBAXY
AB
AB
SANDOZ
AB
AB
TEVA
AB
AB +
AMOXIL
DR REDDYS LABS INC
AB
AB
TABLET, CHEWABLE; ORAL
AMOXICILLIN
DAVA PHARMS INC
AB
AB
RANBAXY
AB
AB
TEVA
AB
AB +
AMOXIL
DR REDDYS LABS INC
AB
AB
AB
AB
AMOXICILLIN
RANBAXY
XX
XX

TABLET, FOR SUSPENSION; ORAL

AMOXICILLIN
AUROBINDO PHARMA
AB
200MG
AB
400MG
DISPERMOX
600MG
XX + RANBAXY

005
001
001
002
002

001
002
001
001
001
002
001
002
001
002

Apr 15, 1999

Nov
Nov
Jan
Mar
Nov
Nov
Jul
Jul
Sep
Sep

09,
09,
15,
29,
24,
24,
13,
13,
18,
18,

29,
29,
23,
23,
11,
22,

2005
2005
2009
2006
2000
2000
2005
2005
2000
2000

1996
1996
1999
1999
1995
1992

Apr 15, 1999

Apr 15, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 32 (of 424)

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS; ORAL

PREVPAC

500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M
XX + TAKEDA PHARMS NA
G

N050757 001

Dec 02, 1997

N050824 001

Feb 08, 2011

A065191
A065191
A065373
A065098
A065098
A065358
A065132
A065132
A065207
A065066
A065066
A065089
A065089
A065162
A065431

Jan
Jan
Nov
Dec
Dec
Aug
Mar
Mar
Jan
Jun
Jun
May
May
Mar
Nov

AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE, TABLET; ORAL

OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN

XX + GASTROENTERO
500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20M
G

AMOXICILLIN; CLAVULANATE POTASSIUM

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

FOR SUSPENSION; ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM
HIKMA PHARMS
200MG/5ML;EQ 28.5MG BASE/5ML
400MG/5ML;EQ 57MG BASE/5ML
600MG/5ML;EQ 42.9MG BASE/5ML
LEK PHARMS
200MG/5ML;EQ 28.5MG BASE/5ML
400MG/5ML;EQ 57MG BASE/5ML
LEK PHARMS DD
600MG/5ML;EQ 42.9MG BASE/5ML
RANBAXY
200MG/5ML;EQ 28.5MG BASE/5ML
400MG/5ML;EQ 57MG BASE/5ML
600MG/5ML;EQ 42.9MG BASE/5ML
SANDOZ
200MG/5ML;EQ 28.5MG BASE/5ML
400MG/5ML;EQ 57MG BASE/5ML
TEVA
200MG/5ML;EQ 28.5MG BASE/5ML
+
400MG/5ML;EQ 57MG BASE/5ML
+
600MG/5ML;EQ 42.9MG BASE/5ML
WOCKHARDT
250MG/5ML;EQ 62.5MG BASE/5ML
AUGMENTIN '125'
DR REDDYS LABS INC
125MG/5ML;EQ 31.25MG BASE/5ML
AUGMENTIN '200'
DR REDDYS LABS INC
200MG/5ML;EQ 28.5MG BASE/5ML
AUGMENTIN '250'
+ DR REDDYS LABS INC
250MG/5ML;EQ 62.5MG BASE/5ML
AUGMENTIN '400'
DR REDDYS LABS INC
400MG/5ML;EQ 57MG BASE/5ML
AUGMENTIN ES-600
DR REDDYS LABS INC
600MG/5ML;EQ 42.9MG BASE/5ML

002
001
001
001
002
001
001
002
002
001
002
001
002
001
001

25,
25,
09,
16,
16,
13,
19,
19,
30,
05,
05,
25,
25,
12,
25,

2005
2005
2007
2002
2002
2007
2003
2003
2007
2002
2002
2004
2004
2004
2008

N050575 001

Aug 06, 1984

N050725 001

May 31, 1996

N050575 002

Aug 06, 1984

N050725 002

May 31, 1996

N050755 001

Jun 22, 2001

SUSPENSION; ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AUROBINDO PHARMA LTD 200MG/5ML;EQ 28.5MG BASE/5ML
AB
AB
400MG/5ML;EQ 57MG BASE/5ML
AB
600MG/5ML;EQ 42.9MG BASE/5ML

A201090 001
A201090 002
A201091 001

Dec 20, 2011

Dec 20, 2011
Dec 20, 2011

TABLET; ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
APOTEX
AB
250MG;EQ 125MG
AB
500MG;EQ 125MG
APOTEX INC
AB
875MG;EQ 125MG
LEK PHARMS
AB
500MG;EQ 125MG
AB
875MG;EQ 125MG
RANBAXY
AB
500MG;EQ 125MG
AB
875MG;EQ 125MG
SANDOZ
AB
250MG;EQ 125MG
AB
500MG;EQ 125MG
AB
875MG;EQ 125MG
TEVA
AB
500MG;EQ 125MG
AB +
875MG;EQ 125MG

A065333
A065333
A065317
A065117
A065093
A065109
A065102
A065189
A065064
A065063
A065101
A065096

Feb
Feb
Oct
Nov
Nov
Nov
Sep
Aug
Mar
Mar
Oct
Oct

AB
AB
AB
AB
AB

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
002
003
001
001
001
001
001
001
001
001
001

24,
24,
20,
27,
21,
04,
17,
23,
15,
14,
30,
29,

2009
2009
2008
2002
2002
2002
2002
2005
2002
2002
2002
2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 33 (of 424)

AMOXICILLIN; CLAVULANATE POTASSIUM

TABLET; ORAL
AUGMENTIN '250'
DR REDDYS LABS INC
AB
AUGMENTIN '500'
DR REDDYS LABS INC
AB
AUGMENTIN '875'
DR REDDYS LABS INC
AB

250MG;EQ 125MG BASE

N050564 001

Aug 06, 1984

500MG;EQ 125MG BASE

N050564 002

Aug 06, 1984

875MG;EQ 125MG BASE

N050720 001

Feb 13, 1996

A065161
A065161
A065065
A065065
A065205
A065205

Dec
Dec
Apr
Apr
Feb
Feb

TABLET, CHEWABLE; ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM
RANBAXY
AB
200MG;EQ 28.5MG BASE
AB
400MG;EQ 57MG BASE
SANDOZ
AB
200MG;EQ 28.5MG BASE
AB
400MG;EQ 57MG BASE
TEVA
AB
200MG;EQ 28.5MG BASE
AB +
400MG;EQ 57MG BASE
AUGMENTIN '125'
DR REDDYS LABS INC
AB
125MG;EQ 31.25MG BASE
AUGMENTIN '200'
DR REDDYS LABS INC
AB
200MG;EQ 28.5MG BASE
AUGMENTIN '250'
DR REDDYS LABS INC
AB
250MG;EQ 62.5MG BASE
AUGMENTIN '400'
DR REDDYS LABS INC
AB
400MG;EQ 57MG BASE
TABLET, EXTENDED RELEASE; ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
SANDOZ
AB
1GM;EQ 62.5MG BASE
AUGMENTIN XR
AB + DR REDDYS LABS INC
1GM;EQ 62.5MG BASE

001
002
001
002
001
002

03,
03,
18,
18,
09,
09,

2003
2003
2002
2002
2005
2005

N050597 001

Jul 22, 1985

N050726 001

May 31, 1996

N050597 002

Jul 22, 1985

N050726 002

May 31, 1996

A090227 001

Apr 21, 2010

N050785 001

Sep 25, 2002

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE;

DEXTROAMPHETAMINE SULFATE

XX
XX
XX
XX
XX
XX

CAPSULE, EXTENDED RELEASE; ORAL

ADDERALL XR 10
SHIRE
2.5MG;2.5MG;2.5MG;2.5MG
ADDERALL XR 15
SHIRE
3.75MG;3.75MG;3.75MG;3.75MG
ADDERALL XR 20
SHIRE
5MG;5MG;5MG;5MG
ADDERALL XR 25
SHIRE
6.25MG;6.25MG;6.25MG;6.25MG
ADDERALL XR 30
+ SHIRE
7.5MG;7.5MG;7.5MG;7.5MG
ADDERALL XR 5
SHIRE
1.25MG;1.25MG;1.25MG;1.25MG

N021303 001

Oct 11, 2001

N021303 006

May 22, 2002

N021303 002

Oct 11, 2001

N021303 004

May 22, 2002

N021303 003

Oct 11, 2001

N021303 005

May 22, 2002

TABLET; ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
BARR
AB
1.25MG;1.25MG;1.25MG;1.25MG
A040422
AB
1.875MG;1.875MG;1.875MG;1.875MG
A040422
AB
2.5MG;2.5MG;2.5MG;2.5MG
A040422
AB
3.125MG;3.125MG;3.125MG;3.125MG
A040422
AB
3.75MG;3.75MG;3.75MG;3.75MG
A040422
AB
5MG;5MG;5MG;5MG
A040422
AB +
7.5MG;7.5MG;7.5MG;7.5MG
A040422
COREPHARMA
AB
1.25MG;1.25MG;1.25MG;1.25MG
A040444
AB
2.5MG;2.5MG;2.5MG;2.5MG
A040444
AB
5MG;5MG;5MG;5MG
A040444
AB
7.5MG;7.5MG;7.5MG;7.5MG
A040444
SANDOZ
AB
1.25MG;1.25MG;1.25MG;1.25MG
A040439
AB
2.5MG;2.5MG;2.5MG;2.5MG
A040439

001
005
002
006
007
003
004
001
002
003
004
004
001

Feb
Mar
Feb
Mar
Mar
Feb
Feb
Jun
Jun
Jun
Jun
Sep
Jun

11,
19,
11,
19,
19,
11,
11,
19,
19,
19,
19,
27,
14,

2002
2003
2002
2003
2003
2002
2002
2002
2002
2002
2002
2002
2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 34 (of 424)

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE;

DEXTROAMPHETAMINE SULFATE
TABLET; ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
SANDOZ
AB
5MG;5MG;5MG;5MG
A040439
AB
7.5MG;7.5MG;7.5MG;7.5MG
A040439
TEVA PHARMS
AB
1.25MG;1.25MG;1.25MG;1.25MG
A040472
AB
2.5MG;2.5MG;2.5MG;2.5MG
A040472
AB
5MG;5MG;5MG;5MG
A040472
AB
7.5MG;7.5MG;7.5MG;7.5MG
A040472

002
003
001
002
003
004

Jun
Jun
Sep
Sep
Sep
Sep

14,
14,
30,
30,
30,
30,

2002
2002
2003
2003
2003
2003

AMPHOTERICIN B
INJECTABLE; INJECTION
AMPHOTERICIN B
AP + X GEN PHARMS

50MG/VIAL

A063206 001

Apr 29, 1992

INJECTABLE, LIPID COMPLEX; INJECTION

ABELCET

5MG/ML
XX + SIGMA TAU
AMPHOTEC
50MG/VIAL
XX + ALDOPHARMA USA
100MG/VIAL
XX +

N050724 001

Nov 20, 1995

N050729 001
N050729 002

Nov 22, 1996

Nov 22, 1996

INJECTABLE, LIPOSOMAL; INJECTION

AMBISOME

50MG/VIAL
XX + ASTELLAS

N050740 001

Aug 11, 1997

A090354
A090354
A090354
A090354
A065499
A065499
A065499
A065499
A065499
A065493
A063145
A063146
A062772
A063140
A063142
A062719
A062719
A062719
A062797
A062797
A061395
A061395
A061395
A061395
A062738
A061395
A062738
A061395

Dec
Dec
Dec
Dec
Aug
Aug
Aug
Aug
Aug
Aug
Apr
Apr
Apr
Apr
Apr
May
May
May
Jul
Jul

AMPICILLIN SODIUM
INJECTABLE; INJECTION
AMPICILLIN SODIUM
ACIC FINE CHEMS
AP
AP
AP
AP
AUROBINDO PHARMA
AP
AP
AP
AP
AP
AP
HANFORD GC
AP
AP
AP
AP
AP
IBI
AP
AP
AP
INSTITUTO BIOCHEMICO
AP
AP
AP + SANDOZ
AP +
AP +
AP +
AP
AP +
AP
AP +

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
125MG BASE/VIAL
2GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL

001
002
003
004
001
002
003
004
005
001
001
001
001
001
001
001
003
002
001
002
001
002
003
004
001
005
002
006

28,
28,
28,
28,
17,
17,
17,
17,
17,
17,
15,
15,
15,
15,
15,
12,
12,
12,
12,
12,

2009
2009
2009
2009
2010
2010
2010
2010
2010
2010
1993
1993
1993
1993
1993
1987
1987
1987
1993
1993

Feb 19, 1987

Feb 19, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 35 (of 424)

AMPICILLIN SODIUM; SULBACTAM SODIUM

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
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
AMPICILLIN AND SULBACTAM
ACS DOBFAR
EQ
EQ
EQ
AUROBINDO PHARMA
EQ
EQ
EQ
EQ
EQ
BAXTER HLTHCARE
EQ
EQ
EQ
BIONICHE PHARMA
EQ
EQ
HANFORD GC
EQ
EQ
EQ
HOSPIRA INC
EQ
EQ
EQ
EQ
EQ
INSTITUTO BIOCHIMICO EQ
EQ
EQ
SANDOZ
EQ
EQ
EQ
EQ
EQ
UNASYN
PFIZER
EQ
+
EQ
+
EQ
+
EQ

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

2GM BASE/VIAL;EQ 1GM BASE/VIAL
10GM BASE/VIAL;EQ 5GM BASE/VIAL
1GM BASE/VIAL;EQ 500MG BASE/VIAL
1GM BASE/VIAL;EQ 500MG BASE/VIAL
2GM BASE/VIAL;EQ 1GM BASE/VIAL
2GM BASE/VIAL;EQ 1GM BASE/VIAL
10GM BASE/VIAL;EQ 5GM BASE/VIAL
1GM BASE/VIAL;EQ 500MG BASE/VIAL
2GM BASE/VIAL;EQ 1GM BASE/VIAL
10GM BASE/VIAL;EQ 5GM BASE/VIAL
1GM BASE/VIAL;EQ 500MG BASE/VIAL
2GM BASE/VIAL;EQ 1GM BASE/VIAL
1GM BASE/VIAL;EQ 500MG BASE/VIAL
2GM BASE/VIAL;EQ 1GM BASE/VIAL
10GM BASE/VIAL;EQ 5GM BASE/VIAL
1GM BASE/VIAL;EQ 500MG BASE/VIAL
1GM BASE/VIAL;EQ 500MG BASE/VIAL
2GM BASE/VIAL;EQ 1GM BASE/VIAL
2GM BASE/VIAL;EQ 1GM BASE/VIAL
10GM BASE/VIAL;EQ 5GM BASE/VIAL
1GM BASE/VIAL;EQ 500MG BASE/VIAL
2GM BASE/VIAL;EQ 1GM BASE/VIAL
10GM BASE/VIAL;EQ 5GM BASE/VIAL
1GM BASE/VIAL;EQ 500MG BASE/VIAL
1GM BASE/VIAL;EQ 500MG BASE/VIAL
2GM BASE/VIAL;EQ 1GM BASE/VIAL
2GM BASE/VIAL;EQ 1GM BASE/VIAL
10GM BASE/VIAL;EQ 5GM BASE/VIAL

A065406
A065406
A065403
A090340
A090349
A090340
A090349
A090339
A065074
A065074
A065076
A065316
A065316
A065176
A065176
A065188
A090375
A090653
A090375
A090653
A090646
A065222
A065222
A065314
A065241
A065310
A065241
A065310
A065240

001
002
001
001
001
002
002
001
001
002
001
001
002
001
002
001
001
001
002
002
001
001
002
001
001
001
002
002
001

Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Jun
Jun
Nov
Nov
Nov
Dec
Dec
Dec
Dec
Dec
Nov
Nov
Nov
Jul
Jul
Jul
Jul
Jul

22,
22,
23,
20,
20,
20,
20,
20,
19,
19,
19,
29,
29,
30,
30,
25,
21,
21,
21,
21,
21,
29,
29,
27,
25,
25,
25,
25,
25,

2009
2009
2009
2010
2010
2010
2010
2010
2002
2002
2002
2007
2007
2005
2005
2005
2011
2011
2011
2011
2011
2005
2005
2006
2006
2006
2006
2006
2006

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

1GM BASE/VIAL;EQ 500MG BASE/VIAL
2GM BASE/VIAL;EQ 1GM BASE/VIAL
10GM BASE/VIAL;EQ 5GM BASE/VIAL

A062901
N050608
N050608
N050608

001
002
001
005

Nov
Dec
Dec
Dec

23,
31,
31,
10,

1988
1986
1986
1993

A062883
A062882
A064082
A064082

001
001
001
002

Feb
Feb
Aug
Aug

25,
25,
29,
29,

1988
1988
1995
1995

AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE; ORAL
AMPICILLIN TRIHYDRATE
DAVA PHARMS INC
AB
AB +
SANDOZ
AB
AB

EQ
EQ
EQ
EQ

FOR SUSPENSION; ORAL

AMPICILLIN TRIHYDRATE
DAVA PHARMS INC
XX
XX +

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

250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE

A062982 001
A062982 002

Feb 10, 1989

Feb 10, 1989

0.5MG BASE

N020333 001

Mar 14, 1997

0.5MG BASE
1MG BASE
0.5MG BASE
1MG BASE
0.5MG BASE

A077613
A077613
A076530
A076530
A076910

Jun
Jun
Apr
Apr
Apr

ANAGRELIDE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
AGRYLIN
SHIRE
EQ
ANAGRELIDE HYDROCHLORIDE
ALPHAPHARM
EQ
EQ
BARR
EQ
EQ
IMPAX LABS
EQ

001
002
001
002
001

27,
27,
18,
18,
18,

2006
2006
2005
2005
2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 36 (of 424)

ANAGRELIDE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
ANAGRELIDE HYDROCHLORIDE
IMPAX LABS
EQ
IVAX SUB TEVA PHARMS EQ
+
EQ
MYLAN
EQ
EQ
SANDOZ
EQ
EQ
WATSON LABS
EQ
EQ

A076910
A076468
A076468
A076811
A076811
A076683
A076683
A076417
A076417

002
001
002
001
002
001
002
001
002

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

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

2005
2005
2005
2005
2005
2005
2005
2005
2005

1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG

A090568
A090732
A090088
A091331
A091051
A079220
A078485
A079007
A078944
A091177
A078058
A091164
A078984
A078921

001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jun
Jun
Jan
Jun
Jun
Jun
Jun
Jun
Jul
Jun
Jun
Jun
Jun

28,
28,
28,
05,
28,
28,
28,
28,
28,
15,
28,
28,
28,
28,

2010
2010
2010
2011
2010
2010
2010
2010
2010
2011
2010
2010
2010
2010

1MG

N020541 001

Dec 27, 1995

N021632 001
N021632 002

Feb 17, 2006

Nov 14, 2006

N021264 002

Apr 20, 2004

A077764 001

Mar 12, 2009

N020258 001

Jul 30, 1993

N019779 001

Dec 31, 1987

N021549 003
N021549 001
N021549 002

Jun 30, 2006

Mar 26, 2003
Mar 26, 2003

1MG BASE
0.5MG BASE
1MG BASE
0.5MG BASE
1MG BASE
0.5MG BASE
1MG BASE
0.5MG BASE
1MG BASE

ANASTROZOLE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
ANASTROZOLE
ACCORD HLTHCARE INC
DR REDDYS LABS LTD
FRESENIUS KABI ONCOL
KUDCO IRELAND
MYLAN
NATCO PHARMA LTD
ROXANE
SANDOZ
SANTOS BIOTECH
SUN PHARM INDS LTD
TEVA PHARMS
THREE RIVERS PHARMS
WATSON LABS
ZYDUS PHARMS USA INC
ARIMIDEX
+ ASTRAZENECA

ANIDULAFUNGIN
INJECTABLE; IV (INFUSION)

ERAXIS

XX + VICURON
50MG/VIAL
XX +
100MG/VIAL

APOMORPHINE HYDROCHLORIDE
INJECTABLE; SUBCUTANEOUS

APOKYN

XX + US WORLDMEDS

30MG/3ML (10MG/ML)

APRACLONIDINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
APRACLONIDINE HYDROCHLORIDE
AKORN INC
AT
EQ 0.5% BASE
IOPIDINE
AT + ALCON
EQ 0.5% BASE
IOPIDINE
EQ 1% BASE
XX + ALCON

APREPITANT
CAPSULE; ORAL
EMEND
MERCK
XX
XX
XX +

40MG
80MG
125MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 37 (of 424)

APROTININ
INJECTABLE; INJECTION

TRASYLOL

XX + BAYER HLTHCARE

10,000KIU/ML

N020304 001

Dec 29, 1993

EQ 0.015MG BASE/2ML

N021912 001

Oct 06, 2006

100MG/ML

N020883 001

Jun 30, 2000

N022434 001
N022485 001

Jun 29, 2011

May 09, 2011

ARFORMOTEROL TARTRATE
SOLUTION; INHALATION

BROVANA

XX + SUNOVION

ARGATROBAN
INJECTABLE; INJECTION

ARGATROBAN

XX + PFIZER

INJECTABLE; IV (INFUSION)

ARGATROBAN IN SODIUM CHLORIDE

XX + EAGLE PHARMS
50MG/50ML (1MG/ML)
XX + SANDOZ
125MG/125ML (1MG/ML)

ARGININE HYDROCHLORIDE
INJECTABLE; INJECTION

R-GENE 10

XX + PHARMACIA AND UPJOHN 10GM/100ML

N016931 001

ARIPIPRAZOLE
INJECTABLE; INTRAMUSCULAR

ABILIFY

XX + OTSUKA
9.75MG/1.3ML (7.5MG/ML)

N021866 001

Sep 20, 2006

SOLUTION; ORAL

ABILIFY

XX + OTSUKA

1MG/ML

N021713 001

Dec 10, 2004

TABLET; ORAL

ABILIFY

OTSUKA

XX
XX +

XX +

XX
XX
XX

2MG
5MG
10MG
15MG
20MG
30MG

N021436
N021436
N021436
N021436
N021436
N021436

Nov
Nov
Nov
Nov
Nov
Nov

TABLET, ORALLY DISINTEGRATING; ORAL

ABILIFY

XX + OTSUKA
10MG
XX
15MG

006
005
001
002
003
004

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

2002
2002
2002
2002
2002
2002

N021729 002
N021729 003

Jun 07, 2006

Jun 07, 2006

50MG
150MG
250MG

N021875 001
N021875 003
N021875 004

Jun 15, 2007

Jun 15, 2007
Jun 15, 2007

1MG/ML

N021248 001

Sep 25, 2000

ARMODAFINIL
TABLET; ORAL

NUVIGIL

CEPHALON

XX
XX
XX +

ARSENIC TRIOXIDE
INJECTABLE; INJECTION

TRISENOX

XX + CEPHALON

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 38 (of 424)

ARTEMETHER; LUMEFANTRINE
TABLET; ORAL

COARTEM

XX + NOVARTIS

20MG;120MG

N022268 001

Apr 07, 2009

A079138 001

Jun 18, 2010

N020971 001

Apr 03, 2000

N022466 001

Feb 26, 2010

N022466 002

Feb 26, 2010

N022010 001

Mar 30, 2006

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

INJECTABLE; INJECTION
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
HOSPIRA
AP
4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG
BASE/ML)
SEPTOCAINE
AP + DEPROCO
4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG
BASE/ML)
ARTICAINE HYDROCHLORIDE WITH EPINEPHRINE
PIERREL
4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG
XX
BASE/ML)
4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG
XX +
BASE/ML)

SEPTOCAINE

4%;EQ 0.0085MG BASE/1.7ML (4%;EQ

XX + DEPROCO
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

80MG/VIAL;0.02MG/VIAL;400
XX + SANDOZ
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
XX

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)

+ SANDOZ
80MG/VIAL;0.02MG/VIAL;400
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

N021265 001

Feb 21, 2001

N021646 001

Jan 29, 2004

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
XX + HOSPIRA
80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/
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

N018920 001

Sep 21, 2000

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)

XX + HOSPIRA
20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;
0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0
.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

N008809 006

Sep 09, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 39 (of 424)

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
XX + HOSPIRA
200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M
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
XX

M.V.I. ADULT (PHARMACY BULK PACKAGE)

+ HOSPIRA
200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5
ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5
ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0
.15MG/5ML

N021625 001

Jan 30, 2004

N021643 001

Feb 18, 2004

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE;

SODIUM CHLORIDE; SODIUM SULFATE
FOR SOLUTION; ORAL

MOVIPREP

XX + SALIX PHARMS

4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

N021881 001

Aug 02, 2006

EQ 5MG BASE
EQ 10MG BASE

N022117 001
N022117 002

Aug 13, 2009

Aug 13, 2009

325MG;50MG;40MG

N017534 005

Apr 16, 1986

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

A075231 001
A074951 001
A074359 001

Nov 30, 2001

Aug 31, 1998
Aug 31, 1995

N019429 003

Oct 26, 1990

N011483 004

Sep 06, 1983

385MG;30MG;25MG

A074817 001

Nov 27, 1996

770MG;60MG;50MG

A074817 002

Nov 27, 1996

385MG;30MG;25MG

N013416 003

Oct 27, 1982

770MG;60MG;50MG

N013416 004

Oct 27, 1982

ASENAPINE MALEATE
TABLET; SUBLINGUAL
SAPHRIS
XX
ORGANON USA INC
XX +

ASPIRIN; BUTALBITAL; CAFFEINE

CAPSULE; ORAL
FIORINAL
AA + WATSON LABS INC
LANORINAL
LANNETT
AA

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

AB
AB
AB
AB

CAPSULE; ORAL
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
NEXGEN PHARMA INC
325MG;50MG;40MG;30MG
STEVENS J
325MG;50MG;40MG;30MG
WATSON LABS
325MG;50MG;40MG;30MG
FIORINAL W/CODEINE
+ WATSON LABS INC
325MG;50MG;40MG;30MG

ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE

CAPSULE; ORAL

SYNALGOS-DC

XX + CARACO

356.4MG;30MG;16MG

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

AB
AB
AB
AB

TABLET; ORAL
INVAGESIC
SANDOZ
INVAGESIC FORTE
SANDOZ
NORGESIC
MEDICIS
NORGESIC FORTE
+ MEDICIS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 40 (of 424)

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

TABLET; ORAL
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
SANDOZ
AB
385MG;30MG;25MG
AB
770MG;60MG;50MG
STEVENS J
AB
385MG;30MG;25MG
AB
770MG;60MG;50MG

A074654
A074654
A074988
A074988

001
002
001
002

Dec
Dec
Apr
Apr

31,
31,
30,
30,

1996
1996
1999
1999

A089594
A040832
A040252
A040116

001
001
001
001

Mar
Jan
Dec
Apr

31,
07,
10,
25,

1989
2010
1997
1996

ASPIRIN; CARISOPRODOL

AB
AB
AB
AB
AB

TABLET; ORAL
CARISOPRODOL AND ASPIRIN
HERITAGE PHARMS INC
325MG;200MG
MIRROR PHARMS
325MG;200MG
PROSAM LABS
325MG;200MG
SANDOZ
325MG;200MG
SOMA COMPOUND
+ MEDA PHARMS
325MG;200MG

N012365 005

Jul 11, 1983

A040860 001
A040283 001
A040118 001

Jan 07, 2010

Dec 29, 1998
Apr 16, 1996

N012366 002

Jul 11, 1983

N020884 001

Nov 22, 1999

A078804 001

Aug 14, 2009

A081145 001

Jan 31, 1995

325MG;4.8355MG
325MG;4.8355MG

A091670 001
A090084 001

Mar 16, 2011

Mar 22, 2011

325MG;4.8355MG

N007337 007

Aug 05, 2005

325MG;4.5MG;0.38MG

A040255 001

Feb 27, 1998

EQ
EQ
EQ
EQ

N021567
N021567
N021567
N021567

Jun
Jun
Jun
Oct

ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE

AB
AB
AB
AB

TABLET; ORAL
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
MIRROR PHARMS
325MG;200MG;16MG
PROSAM LABS
325MG;200MG;16MG
SANDOZ
325MG;200MG;16MG
SOMA COMPOUND W/ CODEINE
+ MEDA PHARMS
325MG;200MG;16MG

ASPIRIN; DIPYRIDAMOLE
CAPSULE, EXTENDED RELEASE; ORAL
AGGRENOX
AB + BOEHRINGER INGELHEIM 25MG;200MG
ASPIRIN AND DIPYRIDAMOLE
BARR
AB
25MG;200MG

ASPIRIN; METHOCARBAMOL
TABLET; ORAL

METHOCARBAMOL AND ASPIRIN

325MG;400MG
XX + STEVENS J

ASPIRIN; OXYCODONE HYDROCHLORIDE

TABLET; ORAL
OXYCODONE AND ASPIRIN
COASTAL PHARMS
AA
WATSON LABS
AA
PERCODAN
AA + ENDO PHARMS

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

TABLET; ORAL
OXYCODONE AND ASPIRIN
WATSON LABS
XX

ATAZANAVIR SULFATE
CAPSULE; ORAL
REYATAZ
BRISTOL MYERS SQUIBB
XX
XX
XX
XX +

100MG
150MG
200MG
300MG

BASE
BASE
BASE
BASE

001
002
003
004

20,
20,
20,
16,

2003
2003
2003
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 41 (of 424)

ATENOLOL
TABLET; ORAL
ATENOLOL
AUROBINDO PHARMA
AB
AB
AB
CARACO
AB
AB
AB
DAVA PHARMS INC
AB
AB
AB
IPCA LABS LTD
AB
AB
AB
IPR
AB
AB
AB
MUTUAL PHARM
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
NORTHSTAR HLTHCARE
AB
AB
AB
SANDOZ
AB
AB
AB
TEVA
AB
AB
AB
UNIQUE PHARM LABS
AB
AB
AB
WATSON LABS
AB
AB
ZYDUS PHARMS USA
AB
AB
AB
TENORMIN
ASTRAZENECA
AB
AB
AB +

001
002
003
001
002
003
001
001
001
001
002
003
001
001
001
001
001
001
002
003
001
001
001
002
001
002
003
001
001
001
003
001
002
001
002
003
001
001
001
002
003

Oct
Oct
Oct
Jul
Jul
Jul
Apr
Dec
Dec
Dec
Dec
Dec
Jul
Jul
Jul
Jul
Mar
Mar
Apr
Aug
Jan
Mar
Jan
Mar
Sep
Sep
Sep
May
Sep
Sep
Jul
Jan
Jan
Sep
Sep
Sep
Dec
Dec
Jan
Jan
Jan

31,
31,
31,
10,
10,
10,
28,
19,
19,
27,
27,
27,
31,
15,
15,
30,
30,
30,
26,
26,
24,
23,
24,
23,
25,
25,
25,
01,
17,
17,
19,
18,
18,
13,
13,
13,
27,
27,
28,
28,
28,

2007
2007
2007
2007
2007
2007
1992
1991
1991
2006
2006
2006
1992
1988
1988
1997
1993
1993
1999
1998
1992
1994
1992
1994
2009
2009
2009
1992
1991
1991
2004
1995
1995
2006
2006
2006
1991
1991
2005
2005
2005

25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
25MG
50MG
50MG
100MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
50MG
100MG
25MG
50MG
100MG

A078512
A078512
A078512
A078210
A078210
A078210
A074099
A073542
A073543
A077877
A077877
A077877
A073646
A072303
A072304
A074499
A073475
A073476
A073457
A074126
A073456
A074126
A073457
A074126
A078254
A078254
A078254
A074052
A073025
A073026
A074056
A074056
A074056
A077443
A077443
A077443
A073352
A073353
A076900
A076900
A076900

25MG
50MG
100MG

N018240 004
N018240 001
N018240 002

Apr 09, 1990

A072301
A072302
A073581
A073582
A074203
A074203
A073665
A073665

May
May
Apr
Apr
Oct
Oct
Jul
Jul

ATENOLOL; CHLORTHALIDONE
TABLET; ORAL
ATENOLOL AND CHLORTHALIDONE
IPR
AB
50MG;25MG
AB
100MG;25MG
MUTUAL PHARM
AB
50MG;25MG
AB
100MG;25MG
MYLAN
AB
50MG;25MG
100MG;25MG
AB
WATSON LABS
AB
50MG;25MG
AB
100MG;25MG

001
001
001
001
001
002
001
002

31,
31,
29,
29,
31,
31,
02,
02,

1990
1990
1993
1993
1993
1993
1992
1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 42 (of 424)

ATENOLOL; CHLORTHALIDONE
TABLET; ORAL
TENORETIC 100
AB + ASTRAZENECA
TENORETIC 50
ASTRAZENECA
AB

100MG;25MG

N018760 001

Jun 08, 1984

50MG;25MG

N018760 002

Jun 08, 1984

A079016
A079016
A079016
A079016
A079016
A079016
A079016
A079021
A079021
A079021
A079021
A079021
A079021
A079021
A079018
A079018
A079018
A079018
A079018
A079018
A079018
A079020
A079020
A079020
A079020
A079020
A079020
A079020
A079022
A079022
A079022
A079022
A079022
A079022
A079022
A079017
A079017
A079017
A079017
A079017
A079017

001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Sep

13,
13,
13,
13,
13,
13,
13,
30,
30,
30,
30,
30,
30,
30,
13,
13,
13,
13,
13,
13,
13,
30,
30,
30,
30,
30,
30,
30,
01,
01,
01,
01,
01,
01,
01,
17,
17,
17,
17,
17,
17,

2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010

N021411
N021411
N021411
N021411
N021411
N021411
N021411

002
003
004
005
006
007
008

Nov
Nov
Nov
Nov
Nov
Feb
Feb

26,
26,
26,
26,
26,
14,
14,

2002
2002
2002
2002
2002
2005
2005

ATOMOXETINE HYDROCHLORIDE
CAPSULE; ORAL
ATOMOXETINE HYDROCHLORIDE
AUROBINDO PHARM
AB
10MG
AB
18MG
AB
25MG
AB
40MG
AB
60MG
AB
80MG
AB
100MG
MYLAN
AB
10MG
AB
18MG
AB
25MG
AB
40MG
AB
60MG
AB
80MG
AB
100MG
SANDOZ
AB
10MG
AB
18MG
AB
25MG
AB
40MG
AB
60MG
AB
80MG
AB
100MG
SUN PHARMA GLOBAL
AB
10MG
AB
18MG
AB
25MG
AB
40MG
AB
60MG
AB
80MG
AB
100MG
TEVA PHARMS
AB
10MG
AB
18MG
AB
25MG
AB
40MG
AB
60MG
AB
80MG
AB
100MG
ZYDUS PHARMS USA INC 18MG
AB
AB
25MG
AB
40MG
AB
60MG
AB
80MG
AB
100MG
STRATTERA
LILLY
AB
10MG
AB
18MG
AB
25MG
AB
40MG
AB +
60MG
AB
80MG
AB
100MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 43 (of 424)

ATORVASTATIN CALCIUM
TABLET; ORAL
ATORVASTATIN CALCIUM
RANBAXY LABS LTD
AB
AB
AB
AB
LIPITOR
PFIZER
AB
AB
AB
AB +

EQ
EQ
EQ
EQ

10MG
20MG
40MG
80MG

BASE
BASE
BASE
BASE

A076477
A076477
A076477
A076477

001
002
003
004

Nov
Nov
Nov
Nov

30,
30,
30,
30,

2011
2011
2011
2011

EQ
EQ
EQ
EQ

10MG
20MG
40MG
80MG

BASE
BASE
BASE
BASE

N020702
N020702
N020702
N020702

001
002
003
004

Dec
Dec
Dec
Apr

17,
17,
17,
07,

1996
1996
1996
2000

ATOVAQUONE
SUSPENSION; ORAL

MEPRON

XX + GLAXOSMITHKLINE LLC

750MG/5ML

N020500 001

Feb 08, 1995

A091211 001

Jan 12, 2011

N021078 001

Jul 14, 2000

N021078 002

Jul 14, 2000

A074901 001

Jul 18, 1997

A074900 001

Jul 18, 1997

N017106
N017106
N017106
N017106

004
003
002
001

Sep 17, 2004

Jun 19, 2003
Jun 19, 2003

N021146 002
N021146 001

Jul 09, 2001

Jul 09, 2001

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

TABLET; ORAL
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
GLENMARK GENERICS
AB
250MG;100MG
MALARONE
AB + GLAXOSMITHKLINE
250MG;100MG
MALARONE PEDIATRIC
GLAXOSMITHKLINE
62.5MG;25MG
XX

ATRACURIUM BESYLATE
INJECTABLE; INJECTION

ATRACURIUM BESYLATE

10MG/ML
XX + BEDFORD
ATRACURIUM BESYLATE PRESERVATIVE FREE
10MG/ML
XX + BEDFORD

ATROPINE

XX
XX
XX
XX

INJECTABLE; INJECTION

ATROPEN

+ MERIDIAN MEDCL TECHN

+
+
+

EQ
EQ
EQ
EQ

0.25MG SULFATE/0.3ML
0.5MG SULFATE/0.7ML
1MG SULFATE/0.7ML
2MG SULFATE/0.7ML

ATROPINE SULFATE
INJECTABLE; IM-IV-SC
ATROPINE SULFATE ANSYR PLASTIC SYRINGE
XX
HOSPIRA
0.05MG/ML
XX +
0.1MG/ML

ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

TABLET; ORAL

MOTOFEN

XX + VALEANT

0.025MG;1MG

N017744 002

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

SOLUTION; ORAL
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ROXANE
AA
0.025MG/5ML;2.5MG/5ML
LOMOTIL
AA + GD SEARLE LLC
0.025MG/5ML;2.5MG/5ML

A087708 001
N012699 001

May 03, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 44 (of 424)

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

AA
AA
AA
AA
AA

TABLET; ORAL
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
LANNETT
0.025MG;2.5MG
MYLAN
0.025MG;2.5MG
PAR PHARM
0.025MG;2.5MG
LOMOTIL
+ GD SEARLE LLC
0.025MG;2.5MG
LONOX
SANDOZ
0.025MG;2.5MG

A085372 001
A085762 001
A040357 001

May 02, 2000

N012462 001
A085311 002

ATROPINE SULFATE; EDROPHONIUM CHLORIDE

INJECTABLE; INJECTION

ENLON-PLUS

XX + MYLAN INSTITUTIONAL

0.14MG/ML;10MG/ML

N019678 001

Nov 06, 1991

N021983 001

Sep 28, 2006

3MG

N018689 001

May 24, 1985

100MG/VIAL

N050794 001

May 19, 2004

25MG
50MG
75MG
100MG

A075252
A075252
A075252
A075252

002
001
003
004

Feb
Jun
Feb
Feb

03,
07,
03,
03,

2003
1999
2003
2003

50MG
50MG
25MG
50MG
75MG
100MG

A075568
A074069
A077621
A077621
A077621
A077621

001
001
002
001
003
004

Dec
Feb
Sep
Mar
Sep
Sep

13,
16,
05,
15,
05,
05,

1999
1996
2008
2007
2008
2008

50MG

N016324 001

EQ 100MG BASE/VIAL

A074419 001

Mar 31, 1995

20%

N020428 001

Sep 13, 1995

ATROPINE; PRALIDOXIME CHLORIDE

INJECTABLE; INTRAMUSCULAR

DUODOTE

2.1MG/0.7ML;600MG/2ML
XX + MERIDIAN MEDCL

AURANOFIN
CAPSULE; ORAL

RIDAURA

XX + PROMETHEUS LABS

AZACITIDINE
INJECTABLE; IV-SC

VIDAZA

XX + CELGENE

AZATHIOPRINE
TABLET; ORAL
AZASAN
AAIPHARMA LLC
AB
AB
AB
AB
AZATHIOPRINE
MYLAN
AB
ROXANE
AB
ZYDUS PHARMS USA
AB
AB
AB
AB
IMURAN
AB + PROMETHEUS LABS

AZATHIOPRINE SODIUM
INJECTABLE; INJECTION

AZATHIOPRINE SODIUM

XX + BEDFORD

AZELAIC ACID
CREAM; TOPICAL

AZELEX

XX + ALLERGAN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 45 (of 424)

AZELAIC ACID
GEL; TOPICAL

FINACEA

XX + INTENDIS

15%

N021470 001

Dec 24, 2002

A078621 001
A078738 001

Aug 03, 2009

Jun 21, 2010

N021127 001

May 22, 2000

N020114 001

Nov 01, 1996

A077954 001

Apr 30, 2009

N022371 001

Aug 31, 2009

N200796 001
N200796 002

Feb 25, 2011

Feb 25, 2011

EQ 40MG MEDOXOMIL;12.5MG
EQ 40MG MEDOXOMIL;25MG

N202331 001
N202331 002

Dec 20, 2011

Dec 20, 2011

EQ
EQ
EQ
EQ
EQ
EQ

A065246
A065246
A065297
A065297
A065419
A065419

Jul
Jul
Sep
Sep
Jun
Jun

AZELASTINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
AZELASTINE HYDROCHLORIDE
APOTEX INC
AT
0.05%
SUN PHARMA GLOBAL
AT
0.05%
OPTIVAR
AT + MEDA PHARMS
0.05%
SPRAY, METERED; NASAL
ASTELIN
AB + MEDA PHARMS
EQ 0.125MG BASE/SPRAY
AZELASTINE HYDROCHLORIDE
APOTEX INC
AB
EQ 0.125MG BASE/SPRAY
ASTEPRO
EQ 0.1876MG BASE/SPRAY
XX + MEDA PHARMS

AZILSARTAN KAMEDOXOMIL
TABLET; ORAL
EDARBI
XX
TAKEDA PHARMS
XX +

EQ 40MG MEDOXOMIL
EQ 80MG MEDOXOMIL

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

TABLET; ORAL
EDARBYCLOR
TAKEDA PHARMS
XX
XX +

AZITHROMYCIN
FOR SUSPENSION; ORAL
AZITHROMYCIN
PLIVA
AB
AB
SANDOZ
AB
AB
TEVA PHARMS
AB
AB
ZITHROMAX
PFIZER
AB
AB +
ZITHROMAX
XX + PFIZER

100MG
200MG
100MG
200MG
100MG
200MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

002
001
001
002
001
002

05,
05,
18,
18,
24,
24,

2006
2006
2006
2006
2008
2008

EQ 100MG BASE/5ML
EQ 200MG BASE/5ML

N050710 001
N050710 002

Oct 19, 1995

Oct 19, 1995

EQ 1GM BASE/PACKET

N050693 001

Sep 28, 1994

FOR SUSPENSION, EXTENDED RELEASE; ORAL

ZMAX

EQ 2GM BASE/BOT
XX + PFIZER GLOBAL

N050797 001

Jun 10, 2005

INJECTABLE; INJECTION
AZITHROMYCIN
APP PHARMS
AP
GLAND PHARMA LTD
AP
HOSPIRA
AP
AP
PLIVA HRVATSKA DOO
AP
SAGENT STRIDES
AP
AP + TEVA PARENTERAL

A065179
A065501
A065500
A065511
A065265
A065506
N050809

Dec
Nov
Jun
Jun
Jan
Mar
Dec

EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG
500MG
500MG
500MG
500MG
500MG
500MG

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

001
001
001
001
001
001
001

13,
09,
26,
26,
18,
24,
19,

2005
2009
2009
2009
2007
2009
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 46 (of 424)

AZITHROMYCIN
INJECTABLE; INJECTION
ZITHROMAX
AP + PFIZER
AZITHROMYCIN
XX + TEVA PARENTERAL

EQ 500MG BASE/VIAL

N050733 001

Jan 30, 1997

EQ 2.5GM BASE/VIAL

N050809 002

Dec 19, 2006

N050810 001

Apr 27, 2007

A065507
A065509
A065508
A065365
A065366
A065360
A065225
A065223
A065218
A065211
A065212
A065209
A065153
A065193
A065150
A065404
A065405
A065302

Jul
Jul
Jul
May
May
Jan
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Feb
Feb
Feb

SOLUTION/DROPS; OPHTHALMIC

AZASITE

XX + INSPIRE
1%
TABLET; ORAL
AZITHROMYCIN
APOTEX CORP
AB
AB
AB
MYLAN
AB
AB
AB
PLIVA
AB
AB
AB
SANDOZ
AB
AB
AB
TEVA
AB
AB
AB
WOCKHARDT
AB
AB
AB
ZITHROMAX
PFIZER
AB
AB
AB +

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

250MG
500MG
600MG
250MG
500MG
600MG
250MG
500MG
600MG
250MG
500MG
600MG
250MG
500MG
600MG
250MG
500MG
600MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
003

13,
13,
13,
30,
30,
08,
14,
14,
14,
14,
14,
14,
14,
14,
14,
11,
11,
11,

2011
2011
2011
2007
2007
2007
2005
2005
2005
2005
2005
2005
2005
2005
2005
2008
2008
2008

EQ 250MG BASE
EQ 500MG BASE
EQ 600MG BASE

N050711 001
N050784 001
N050730 001

Jul 18, 1996

May 24, 2002
Jun 12, 1996

75MG/VIAL

N050814 001

Feb 22, 2010

N050580 002
N050580 003

Dec 31, 1986

Dec 31, 1986

A065439
A065439
A065286
A065286

Jun
Jun
Mar
Mar

AZTREONAM
FOR SOLUTION; INHALATION

CAYSTON

XX + GILEAD

INJECTABLE; INJECTION
AZACTAM
AP + BRISTOL MYERS SQUIBB 1GM/VIAL
AP +
2GM/VIAL
AZTREONAM
APP PHARMS
AP
1GM/VIAL
AP
2GM/VIAL
BEDFORD
AP
1GM/VIAL
AP
2GM/VIAL
AZACTAM IN PLASTIC CONTAINER
XX + BRISTOL MYERS SQUIBB 20MG/ML
40MG/ML
XX +
AZTREONAM
APP PHARMS
500MG/VIAL
XX

002
003
001
002

18,
18,
23,
23,

2010
2010
2011
2011

N050632 002
N050632 001

May 24, 1989

May 24, 1989

A065439 001

Jun 18, 2010

50,000 UNITS/VIAL

A064153 001

May 09, 1997

50,000 UNITS/VIAL

A065116 001

Dec 03, 2002

BACITRACIN
INJECTABLE; INJECTION
BACIIM
X GEN PHARMS
AP
BACITRACIN
APP PHARMS
AP

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 47 (of 424)

BACITRACIN
INJECTABLE; INJECTION
BACITRACIN
AP + PHARMACIA AND UPJOHN
SAGENT STRIDES
AP
BACITRACIN

PHARMACIA AND UPJOHN

XX

50,000 UNITS/VIAL
50,000 UNITS/VIAL

A060733 002
A090211 001

10,000 UNITS/VIAL

A060733 001

OINTMENT; OPHTHALMIC

BACITRACIN

XX + FERA PHARMS

500 UNITS/GM

A061212 001

POWDER; FOR RX COMPOUNDING

BACI-RX

X GEN PHARMS
5,000,000 UNITS/BOT
XX

May 11, 2010

A061580 001

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

400 UNITS/GM;1%;EQ 3.5MG

A064068 001
XX + BAUSCH AND LOMB
BASE/GM;10,000 UNITS/GM
OINTMENT; TOPICAL

CORTISPORIN

XX + MONARCH PHARMS

400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000

UNITS/GM

Oct 30, 1995

N050168 002

May 04, 1984

A065088 001

Feb 06, 2004

A064064 001

Oct 30, 1995

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
AKORN
AT
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
UNITS/GM
AT + BAUSCH AND LOMB
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
UNITS/GM
FERA PHARMS
AT
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
UNITS/GM

A060764 002

BACITRACIN ZINC; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC
BACITRACIN ZINC AND POLYMYXIN B SULFATE
AKORN
AT
500 UNITS/GM;10,000 UNITS/GM
AT + BAUSCH AND LOMB
500 UNITS/GM;10,000 UNITS/GM
FERA PHARMS
AT
500 UNITS/GM;10,000 UNITS/GM

A064028 001
A064046 001
A065022 001

Jan 30, 1995

Jan 26, 1995
Feb 27, 2002

BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
400 UNITS/GM;1%;EQ 3.5MG
XX + FERA PHARMS
BASE/GM;10,000 UNITS/GM

A062166 002

BACLOFEN
INJECTABLE; INTRATHECAL
GABLOFEN
CNS THERAPS INC
AP
AP
AP
LIORESAL
AP + MEDTRONIC
AP +
AP +
TABLET; ORAL
BACLOFEN
CARACO
AB

0.05MG/ML
0.5MG/ML
2MG/ML

N022462 001
N022462 002
N022462 003

Nov 19, 2010

Nov 19, 2010
Nov 19, 2010

0.05MG/ML
0.5MG/ML
2MG/ML

N020075 003
N020075 001
N020075 002

Nov 07, 1996

Jun 17, 1992
Jun 17, 1992

10MG

A077984 001

Aug 14, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 48 (of 424)

BACLOFEN
TABLET; ORAL
BACLOFEN
CARACO
AB
IMPAX LABS
AB
AB
IVAX SUB TEVA PHARMS
AB
AB +
LANNETT
AB
AB
MATRIX LABS LTD
AB
AB
MYLAN
AB
AB
NORTHSTAR HLTHCARE
AB
AB
PROSAM LABS
AB
AB
USL PHARMA
AB
AB
VINTAGE PHARMS
AB
AB
WATSON LABS
AB
AB

002
001
002
001
001
001
001
001
002
001
002
001
001
001
001
001
002
001
001
001
001

Aug
Oct
Oct
Jul
Jul
Jul
Dec
Feb
Feb
Jul
Jul
Sep
Sep
Oct
Oct
Aug
Aug
Aug
Aug
Sep
Sep

14,
26,
26,
21,
21,
06,
20,
18,
18,
29,
29,
18,
18,
31,
31,
19,
19,
30,
30,
18,
18,

2006
2007
2007
1988
1988
2007
2005
2010
2010
2005
2005
2009
2009
2007
2007
1996
1996
2005
2005
1991
1991

20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG

A077862
A078146
A077971
A072234
A072235
A078220
A077241
A090334
A090334
A077181
A077121
A078504
A078401
A077089
A077088
A074584
A074584
A077156
A077068
A072824
A072825

750MG
750MG
750MG

A077883 001
A077807 001
A077806 001

Dec 28, 2007

Dec 28, 2007
Dec 28, 2007

750MG

N020610 001

Jul 18, 2000

N020911 002

Sep 15, 2000

N020911 001

Sep 15, 2000

N019389 001

Jul 27, 1987

A077128
A077128
A077128
A077128
A078212
A078212
A078212
A076820
A076820
A076820
A076820

Mar
Mar
Mar
Mar
May
May
May
Feb
Feb
Feb
Feb

BALSALAZIDE DISODIUM

AB
AB
AB
AB

CAPSULE; ORAL
BALSALAZIDE DISODIUM
APOTEX INC
MYLAN
ROXANE
COLAZAL
+ SALIX PHARMS

BECLOMETHASONE DIPROPIONATE
AEROSOL, METERED; INHALATION

QVAR 40

0.04MG/INH
XX + TEVA BRANDED PHARM
QVAR 80

0.08MG/INH
XX + TEVA BRANDED PHARM

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

SPRAY, METERED; NASAL

BECONASE AQ

XX + GLAXOSMITHKLINE

EQ 0.042MG DIPROP/SPRAY

BENAZEPRIL HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
BENAZEPRIL HYDROCHLORIDE
APOTEX INC
5MG
10MG
20MG
40MG
AUROBINDO PHARMA
10MG
20MG
40MG
BIOKEY
5MG
10MG
20MG
40MG

001
002
003
004
001
002
003
001
002
003
004

08,
08,
08,
08,
22,
22,
22,
03,
03,
03,
03,

2006
2006
2006
2006
2008
2008
2008
2006
2006
2006
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 49 (of 424)

BENAZEPRIL HYDROCHLORIDE
TABLET; ORAL
BENAZEPRIL HYDROCHLORIDE
IVAX SUB TEVA PHARMS 5MG
AB
AB
10MG
AB
20MG
AB
40MG
MYLAN
AB
5MG
AB
10MG
AB
20MG
AB
40MG
PRINSTON INC
AB
5MG
AB
10MG
AB
20MG
AB
40MG
RANBAXY
AB
5MG
AB
10MG
AB
20MG
AB
40MG
SANDOZ
AB
5MG
AB
10MG
AB
20MG
AB
40MG
TEVA
AB
5MG
AB
10MG
AB
20MG
AB
40MG
WATSON LABS FLORIDA
AB
5MG
AB
10MG
AB
20MG
AB
40MG
ZYDUS PHARMS USA
AB
5MG
AB
10MG
AB
20MG
AB
40MG
LOTENSIN
NOVARTIS
AB
5MG
AB
10MG
AB
20MG
AB +
40MG

A076333
A076333
A076333
A076333
A076430
A076430
A076430
A076430
A076118
A076118
A076118
A076118
A076344
A076344
A076344
A076344
A076402
A076402
A076402
A076402
A076211
A076211
A076211
A076211
A076267
A076267
A076267
A076267
A078848
A078848
A078848
A078848

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
May
May
May
May

11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
23,
23,
23,
23,

2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2008
2008
2008
2008

N019851
N019851
N019851
N019851

001
002
003
004

Jun
Jun
Jun
Jun

25,
25,
25,
25,

1991
1991
1991
1991

A076348
A076348
A076348
A076348
A076612
A076688
A076612
A076688
A076612
A076688
A076612
A076688
A077483
A077483
A077483
A077483

001
002
003
004
001
001
002
002
003
003
004
004
001
002
003
004

Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Sep
Sep
Sep
Sep

11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
08,
08,
08,
08,

2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2005
2005
2005
2005

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
IVAX SUB TEVA PHARMS 5MG;6.25MG
AB
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
20MG;25MG
MYLAN
AB
5MG;6.25MG
AB
5MG;6.25MG
AB
10MG;12.5MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
20MG;12.5MG
AB
20MG;25MG
AB
20MG;25MG
RANBAXY
AB
5MG;6.25MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
20MG;25MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 50 (of 424)

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
SANDOZ
AB
5MG;6.25MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
20MG;25MG
WATSON LABS FLORIDA
AB
5MG;6.25MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB
20MG;25MG
LOTENSIN HCT
NOVARTIS
AB
5MG;6.25MG
AB
10MG;12.5MG
AB
20MG;12.5MG
AB +
20MG;25MG

A076631
A076631
A076631
A076631
A076342
A076342
A076342
A076342

001
002
003
004
001
002
003
004

Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb

11,
11,
11,
11,
11,
11,
11,
11,

2004
2004
2004
2004
2004
2004
2004
2004

N020033
N020033
N020033
N020033

001
002
004
003

May
May
May
May

19,
19,
19,
19,

1992
1992
1992
1992

BENDAMUSTINE HYDROCHLORIDE
POWDER; IV (INFUSION)

TREANDA

XX + CEPHALON
XX +

25MG/VIAL
100MG/VIAL

N022249 002
N022249 001

May 01, 2009

Mar 20, 2008

N018647 001
N018647 002

May 25, 1983

May 25, 1983

A078688 001
A078688 002

Feb 15, 2008

Feb 15, 2008

A077833 001
A077833 002

Mar 30, 2007

Mar 30, 2007

100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG

A081297
A081297
A040851
A040851
A040795
A040795
A040682
A040682
A040587
A040587
A040627
A040749
A040597
A040597

Jan
Oct
Nov
Nov
Oct
Oct
Jul
Jul
Mar
Mar
Mar
Jul
Jun
Jun

100MG
200MG

N011210 001
N011210 003

Jun 25, 1999

150MG

A040851 002

Nov 09, 2009

BENDROFLUMETHIAZIDE; NADOLOL

AB
AB
AB
AB
AB
AB

TABLET; ORAL
CORZIDE
KING PHARMS
5MG;40MG
+
5MG;80MG
NADOLOL AND BENDROFLUMETHAZIDE
MYLAN
5MG;40MG
5MG;80MG
NADOLOL AND BENDROFLUMETHIAZIDE
IMPAX LABS
5MG;40MG
5MG;80MG

BENZONATATE
CAPSULE; ORAL
BENZONATATE
BANNER PHARMACAPS
AA
AA
MIKART
AA
AA
NESHER PHARMS
AA
AA
ORIT LABS LLC
AA
AA
SUN PHARM INDS INC
AA
AA
THE PHARMA NETWORK
AA
AA
ZYDUS PHARMS USA
AA
AA
TESSALON
AA + FOREST LABS
AA +
BENZONATATE
MIKART
XX

001
002
001
003
001
002
001
002
001
002
001
001
001
002

29,
30,
09,
09,
31,
31,
30,
30,
19,
19,
30,
25,
08,
08,

1993
2007
2009
2009
2007
2007
2007
2007
2008
2008
2007
2007
2007
2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 51 (of 424)

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

AB
AB
BT
BT
XX

GEL; TOPICAL
BENZACLIN
SANOFI AVENTIS US
5%;EQ 1% BASE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
DOW PHARM SCIENCES
5%;EQ 1% BASE
BENZACLIN
+ SANOFI AVENTIS US
5%;EQ 1% BASE
DUAC
+ STIEFEL
5%;EQ 1% BASE
ACANYA
+ DOW PHARM SCI
2.5%;1.2%

N050756 001

Dec 21, 2000

A065443 001

Aug 11, 2009

N050756 002

Apr 20, 2007

N050741 001

Aug 26, 2002

N050819 001

Oct 23, 2008

N050557 001

Oct 26, 1984

A065112 001

Mar 29, 2004

N050769 001

Nov 27, 2000

A040714
A040845
A090968
A040773
A090473
A090473
A040578
A040747

Oct
Nov
Jul
Apr
Sep
Sep
Apr
Mar

BENZOYL PEROXIDE; ERYTHROMYCIN

GEL; TOPICAL
BENZAMYCIN
AB + SANOFI AVENTIS US
5%;3%
ERYTHROMYCIN AND BENZOYL PEROXIDE
TOLMAR
AB
5%;3%
BENZAMYCIN PAK
5%;3%
XX + SANOFI AVENTIS US

BENZPHETAMINE HYDROCHLORIDE

AA
AA
AA
AA
AA
AA
AA
AA
AA

TABLET; ORAL
BENZPHETAMINE HYDROCHLORIDE
COREPHARMA
50MG
IMPAX LABS
50MG
KVK TECH
50MG
MALLINCKRODT INC
50MG
MIKART
25MG
50MG
PADDOCK
50MG
TEDOR PHARM
50MG
DIDREX
+ PHARMACIA AND UPJOHN 50MG

001
001
001
001
001
002
001
001

29,
18,
20,
25,
15,
15,
17,
30,

2007
2008
2010
2007
2010
2010
2006
2007

N012427 002

BENZTROPINE MESYLATE

AP
AP
AP
AP

INJECTABLE; INJECTION
BENZTROPINE MESYLATE
HIKMA FARMACEUTICA
LUITPOLD
NEXUS PHARMS
COGENTIN
+ LUNDBECK INC

TABLET; ORAL
BENZTROPINE MESYLATE
COREPHARMA
AA
AA
AA
INVAGEN PHARMS
AA
AA
AA
AA + LANNETT
AA +
AA +
PLIVA
AA
AA
AA
USL PHARMA
AA
AA

1MG/ML
1MG/ML
1MG/ML

A090287 001
A091152 001
A090233 001

1MG/ML

N012015 001

0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG

A072264
A072265
A072266
A090294
A090294
A090294
A088877
A088894
A088895
A089058
A089059
A089060
A040103
A040103

001
001
001
001
002
003
001
001
001
001
001
001
001
002

Aug 31, 2009

Mar 29, 2010
Jul 28, 2009

Feb
Feb
Feb
Mar
Mar
Mar
Apr
Apr
Apr
Aug
Aug
Aug
Dec
Dec

27,
27,
27,
29,
29,
29,
11,
11,
11,
10,
10,
10,
12,
12,

1989
1989
1989
2010
2010
2010
1985
1985
1985
1988
1988
1988
1996
1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 52 (of 424)

BENZTROPINE MESYLATE
TABLET; ORAL
BENZTROPINE MESYLATE
USL PHARMA
AA
VINTAGE
AA
AA
AA

2MG
0.5MG
1MG
2MG

A040103
A040738
A040742
A040715

003
001
001
003

5%

N022129 001

Dec
Aug
Aug
Aug

12,
27,
27,
27,

1996
2007
2007
2007

BENZYL ALCOHOL
LOTION; TOPICAL

ULESFIA

XX + SHIONOGI INC

Apr 09, 2009

BENZYLPENICILLOYL POLYLYSINE
INJECTABLE; INJECTION

PRE-PEN

XX + ALLERQUEST

60UMOLAR

N050114 001

BEPOTASTINE BESILATE
SOLUTION/DROPS; OPHTHALMIC

BEPREVE

1.5%
XX + ISTA PHARMS

N022288 001

Sep 08, 2009

N020032 001

Jul 01, 1991

N022308 001

May 28, 2009

1GM/SCOOPFUL

N020576 001

Oct 25, 1996

0.6MG/5ML

N014215 002

BERACTANT
SUSPENSION; INTRATRACHEAL

SURVANTA

25MG/ML
XX + ROSS LABS

BESIFLOXACIN HYDROCHLORIDE
SUSPENSION/DROPS; OPHTHALMIC

BESIVANCE

EQ 0.6% BASE
XX + BAUSCH AND LOMB

BETAINE HYDROCHLORIDE
FOR SOLUTION; ORAL

CYSTADANE

XX + RARE DIS THERAP

BETAMETHASONE
SYRUP; ORAL

CELESTONE

XX + SCHERING

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

INJECTABLE; INJECTION
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
LUITPOLD
AB
3MG/ML;EQ 3MG BASE/ML
CELESTONE SOLUSPAN
AB + SCHERING
3MG/ML;EQ 3MG BASE/ML

A090747 001

Jul 31, 2009

N014602 001

BETAMETHASONE DIPROPIONATE
CREAM; TOPICAL
BETAMETHASONE DIPROPIONATE
ACTAVIS MID ATLANTIC EQ 0.05% BASE
AB
AB + FOUGERA
EQ 0.05% BASE
TARO
AB
EQ 0.05% BASE

A070885 001
N019137 001
A073552 001

Feb 03, 1987

Jun 26, 1984
Apr 30, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 53 (of 424)

BETAMETHASONE DIPROPIONATE

AB
AB
AB
AB
AB

CREAM, AUGMENTED; TOPICAL

BETAMETHASONE DIPROPIONATE
ALTANA
EQ
GLENMARK GENERICS
EQ
PERRIGO NEW YORK
EQ
TARO
EQ
TOLMAR
EQ
DIPROLENE AF
+ SCHERING
EQ

0.05%
0.05%
0.05%
0.05%
0.05%

BASE
BASE
BASE
BASE
BASE

A076215
A078930
A076592
A076543
A076603

001
001
001
001
001

Dec
Sep
Dec
Dec
Jan

09,
23,
09,
09,
23,

2003
2008
2003
2003
2004

0.05% BASE

N019555 001

Apr 27, 1987

GEL, AUGMENTED; TOPICAL

BETAMETHASONE DIPROPIONATE
AB + ALTANA
EQ 0.05% BASE
TARO
AB
EQ 0.05% BASE

A075276 001
A076508 001

May 13, 2003

Dec 02, 2003

A070281
A070275
A072538
A071467

Jul
Aug
Jan
Aug

AB

AB
AB
AB
AB

LOTION; TOPICAL
BETAMETHASONE DIPROPIONATE
ACTAVIS MID ATLANTIC EQ 0.05% BASE
+ FOUGERA
EQ 0.05% BASE
PERRIGO NEW YORK
EQ 0.05% BASE
TEVA
EQ 0.05% BASE

001
001
001
001

31,
12,
31,
10,

1985
1985
1990
1987

LOTION, AUGMENTED; TOPICAL

BETAMETHASONE DIPROPIONATE
ALTANA
AB
EQ 0.05% BASE
TARO
AB
EQ 0.05% BASE
DIPROLENE
AB + SCHERING
EQ 0.05% BASE

A077111 001
A077477 001

May 21, 2007

May 21, 2007

N019716 001

Aug 01, 1988

OINTMENT; TOPICAL
BETAMETHASONE DIPROPIONATE
ACTAVIS MID ATLANTIC EQ 0.05% BASE
AB
AB + FOUGERA
EQ 0.05% BASE
TARO
AB
EQ 0.05% BASE

A071012 001
N019141 001
A074271 001

Feb 03, 1987

Sep 04, 1984
Sep 15, 1994

0.05% BASE
0.05% BASE
0.05% BASE

A074304 001
A075373 001
A076753 001

Aug 31, 1995

Jun 22, 1999
Oct 12, 2004

0.05% BASE

N018741 001

Jul 27, 1983

AB
AB
AB
AB

OINTMENT, AUGMENTED; TOPICAL

BETAMETHASONE DIPROPIONATE
ACTAVIS MID ATLANTIC EQ
ALTANA
EQ
TARO
EQ
DIPROLENE
+ SCHERING
EQ

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE

OINTMENT; TOPICAL

TACLONEX

XX + LEO PHARM

0.064%;0.005%

N021852 001

Jan 09, 2006

SUSPENSION; TOPICAL

TACLONEX SCALP

XX + LEO PHARM PRODS

0.064%;0.005%

N022185 001

May 09, 2008

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

CREAM; TOPICAL
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ACTAVIS MID ATLANTIC EQ 0.05% BASE;1%
ALTANA
EQ 0.05% BASE;1%
TARO
EQ 0.05% BASE;1%
LOTRISONE
+ SCHERING
EQ 0.05% BASE;1%

A076002 001
A075502 001
A075673 001

Aug 02, 2002

Jun 05, 2001
May 29, 2001

N018827 001

Jul 10, 1984

LOTION; TOPICAL
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ALTANA PHARMA
AB
EQ 0.05% BASE;1%

A076516 001

Jun 16, 2005

AB
AB
AB
AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 54 (of 424)

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

LOTION; TOPICAL
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
TARO
AB
EQ 0.05% BASE;1%
LOTRISONE
AB + SCHERING PLOUGH RES
EQ 0.05% BASE;1%

A076493 001

Jul 28, 2004

N020010 001

Dec 08, 2000

EQ 0.12% BASE

N020934 001

Feb 28, 1999

EQ 0.1% BASE

N018861 001

Aug 31, 1983

EQ 0.1% BASE

N018642 001

Mar 24, 1983

EQ 0.1% BASE

A072041 001

Jan 06, 1988

EQ 0.1% BASE

A070050 001

Oct 10, 1984

EQ 0.1% BASE
EQ 0.1% BASE

N018866 001
A070052 001

Aug 31, 1983

Jul 31, 1985

EQ 0.1% BASE

A070072 001

Jun 27, 1985

EQ 0.1% BASE
EQ 0.1% BASE

A070051 001
N018865 001

Oct 10, 1984

Aug 31, 1983

A075386
A075630
A075446
A078694

Jun
Apr
Sep
Nov

BETAMETHASONE VALERATE
AEROSOL, FOAM; TOPICAL

LUXIQ

XX + CONNECTICS

AB
AB
AB
AB

CREAM; TOPICAL
BETAMETHASONE VALERATE
+ FOUGERA
BETA-VAL
TEVA
DERMABET
TARO
VALNAC
ACTAVIS MID ATLANTIC

LOTION; TOPICAL
BETAMETHASONE VALERATE
AB + FOUGERA
STI PHARMA LLC
AB
BETA-VAL
TEVA
AB
OINTMENT; TOPICAL
BETAMETHASONE VALERATE
ACTAVIS MID ATLANTIC
AB
AB + FOUGERA

BETAXOLOL HYDROCHLORIDE

AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
BETAXOLOL HYDROCHLORIDE
AKORN
EQ
BAUSCH AND LOMB
EQ
NOVEX
EQ
WOCKHARDT
EQ
BETOPTIC
+ ALCON
EQ

0.5%
0.5%
0.5%
0.5%

BASE
BASE
BASE
BASE

001
001
001
001

30,
12,
28,
16,

2000
2001
2000
2009

N019270 001

Aug 30, 1985

SUSPENSION/DROPS; OPHTHALMIC

BETOPTIC S

EQ 0.25% BASE
XX + ALCON

N019845 001

Dec 29, 1989

TABLET; ORAL
BETAXOLOL HYDROCHLORIDE
EPIC PHARMA
AB
10MG
AB +
20MG
KVK TECH
AB
10MG
AB
20MG

A075541
A075541
A078962
A078962

001
002
001
002

Oct
Oct
Jun
Jun

22,
22,
27,
27,

1999
1999
2008
2008

A040855
A040855
A040855
A040855
A091256
A091256

001
002
003
004
001
002

Nov
Nov
Nov
Nov
May
May

21,
21,
21,
21,
04,
04,

2007
2007
2007
2007
2010
2010

AT

0.5% BASE

BETHANECHOL CHLORIDE
TABLET; ORAL
BETHANECHOL CHLORIDE
AMNEAL PHARM
AA
AA
AA
AA
EMCURE USA
AA
AA

5MG
10MG
25MG
50MG
5MG
10MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 55 (of 424)

BETHANECHOL CHLORIDE
TABLET; ORAL
BETHANECHOL CHLORIDE
EMCURE USA
AA
AA
IMPAX LABS
AA
AA
AA
AA
LANNETT
AA
AA
AA
AA
PHARMAX
AA
AA
AA
AA
SUN PHARM INDS INC
AA
AA
AA
AA
UPSHER SMITH
AA
AA
AA
AA
WOCKHARDT
AA
AA
AA
AA
DUVOID
WELLSPRING PHARM
AA
AA
AA
URECHOLINE
AA + ODYSSEY PHARMS
AA +
AA +
AA +

003
004
001
001
001
004
001
001
003
001
001
001
001
001
001
002
003
004
001
001
001
001
001
001
001
001

May
May
Nov
Nov
Nov
Nov
Mar
Mar
Mar
Mar
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Sep

04,
04,
01,
01,
01,
01,
27,
27,
27,
27,
26,
26,
26,
26,
22,
22,
22,
22,
01,
01,
01,
01,
29,
29,
29,
29,

2010
2010
2006
2006
2006
2006
2008
2008
2008
2008
2007
2007
2007
2007
2009
2009
2009
2009
2005
2005
2005
2005
2003
2003
2003
2003

Dec
May
May
Dec

19,
29,
29,
19,

1985
1984
1984
1985

25MG
50MG
5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG

A091256
A091256
A040739
A040741
A040740
A040721
A040703
A040704
A040678
A040677
A040725
A040726
A040727
A040728
A040897
A040897
A040897
A040897
A040633
A040634
A040635
A040636
A040532
A040533
A040534
A040518

10MG
25MG
50MG

A086262 001
A086263 001
A085882 003

5MG
10MG
25MG
50MG

A089095
A088440
A088441
A089096

CAPSULE; ORAL

TARGRETIN

XX + EISAI INC

75MG

N021055 001

Dec 29, 1999

GEL; TOPICAL

TARGRETIN

XX + EISAI INC

1%

N021056 001

Jun 28, 2000

50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG

A078917
A078634
A079045
A077995
A079185
A078285
A078575
A079110
A077973
A076932

Jul
Aug
May
Jul
Jul
Mar
Jul
Jul
Jul
Jul

001
001
001
001

BEXAROTENE

BICALUTAMIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
BICALUTAMIDE
ACCORD HLTHCARE INC
ACTAVIS TOTOWA
FRESENIUS KABI ONCOL
KUDCO IRELAND
MYLAN
ROXANE
SANDOZ
SUN PHARMA GLOBAL
SYNTHON PHARMS
TEVA

001
001
001
001
001
001
001
001
001
001

06,
28,
13,
06,
06,
24,
06,
06,
06,
06,

2009
2009
2010
2009
2009
2011
2009
2009
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 56 (of 424)

BICALUTAMIDE
TABLET; ORAL
BICALUTAMIDE
ZYDUS PHARMS USA INC
AB
CASODEX
AB + ASTRAZENECA

50MG

A079089 001

Jul 06, 2009

50MG

N020498 001

Oct 04, 1995

SOLUTION/DROPS; OPHTHALMIC

LUMIGAN

0.01%
XX + ALLERGAN
0.03%
XX +

N022184 001
N021275 001

Aug 31, 2010

Mar 16, 2001

SOLUTION/DROPS; TOPICAL

LATISSE

XX + ALLERGAN

0.03%

N022369 001

Dec 24, 2008

2MG

N012003 001

BIMATOPROST

BIPERIDEN HYDROCHLORIDE
TABLET; ORAL

AKINETON

XX + ABBOTT

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

CHLORIDE
FOR SOLUTION; TABLET, DELAYED RELEASE; ORAL

HALFLYTELY

5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM
XX + BRAINTREE
;N/A,5.6GM

N021551 003

Jul 16, 2010

N050786 001

Sep 28, 2006

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE

CAPSULE; ORAL

PYLERA

XX + APTALIS PHARMA US

140MG;125MG;125MG

BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

TABLET, CHEWABLE, TABLET, CAPSULE; ORAL

HELIDAC

262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,5
XX + PROMETHEUS LABS
00MG

N050719 001

Aug 15, 1996

5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG

A077910
A077910
A075831
A075831
A075643
A075643
A075644
A075644
A078635
A078635

Dec
Dec
Dec
Dec
Nov
Nov
Jun
Jun
Aug
Aug

5MG
10MG

N019982 002
N019982 001

BISOPROLOL FUMARATE
TABLET; ORAL
BISOPROLOL FUMARATE
AUROBINDO PHARMA
AB
AB
MYLAN
AB
AB
SANDOZ
AB
AB
TEVA PHARMS
AB
AB
UNICHEM PHARMS (USA)
AB
AB
ZEBETA
DURAMED PHARMS BARR
AB
AB +

001
002
001
002
001
002
001
002
001
002

27,
27,
14,
14,
16,
16,
26,
26,
18,
18,

2006
2006
2005
2005
2000
2000
2001
2001
2009
2009

Jul 31, 1992

Jul 31, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 57 (of 424)

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
BISOPROLOL FUMARATE AND
MYLAN
AB
AB
AB
SANDOZ
AB
AB
AB
UNICHEM
AB
AB
AB
WATSON LABS
AB
AB
AB
ZIAC
DURAMED PHARMS BARR
AB
AB
AB +

HYDROCHLOROTHIAZIDE
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

A075768
A075768
A075768
A075579
A075579
A075579
A079106
A079106
A079106
A075469
A075469
A075469

2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG

N020186 003
N020186 001
N020186 002

Mar 26, 1993

Mar 26, 1993
Mar 26, 1993

250MG/VIAL

N020873 001

Dec 15, 2000

A065185
A065185
A065042
A065042
A065031
A065031
A065201
A065033
A065033

Jan
Jan
Oct
Oct
Mar
Mar
Dec
Jun
Jun

001
002
003
001
002
003
001
002
003
001
002
003

Sep
Sep
Sep
Sep
Sep
Sep
Jul
Jul
Jul
Sep
Sep
Sep

25,
25,
25,
25,
25,
25,
28,
28,
28,
25,
25,
25,

2000
2000
2000
2000
2000
2000
2010
2010
2010
2000
2000
2000

BIVALIRUDIN
INJECTABLE; INTRAVENOUS

ANGIOMAX

XX + MEDICINES CO

BLEOMYCIN SULFATE
INJECTABLE; INJECTION
BLEOMYCIN SULFATE
AP + APP PHARMS
AP +
BEDFORD
AP
AP
HOSPIRA
AP
AP
PHARMACHEMIE BV
AP
TEVA PARENTERAL
AP
AP

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

15
30
15
30
15
30
15
15
30

UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

001
002
002
001
001
002
001
001
002

28,
28,
17,
17,
10,
10,
13,
27,
27,

2008
2008
2001
2001
2000
2000
2007
2000
2000

BOCEPREVIR
CAPSULE; ORAL

VICTRELIS

XX + SCHERING

200MG

N202258 001

May 13, 2011

3.5MG/VIAL

N021602 001

May 13, 2003

62.5MG
125MG

N021290 001
N021290 002

Nov 20, 2001

Nov 20, 2001

N019121 001
N019121 002

Apr 29, 1986

Apr 29, 1986

BORTEZOMIB
INJECTABLE; INTRAVENOUS

VELCADE

XX + MILLENNIUM PHARMS

BOSENTAN
TABLET; ORAL
TRACLEER
ACTELION
XX
XX +

BRETYLIUM TOSYLATE
INJECTABLE; INJECTION

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER

100MG/100ML
XX + B BRAUN
200MG/100ML
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 58 (of 424)

BRETYLIUM TOSYLATE
INJECTABLE; INJECTION

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER

400MG/100ML
XX + B BRAUN

N019121 003

Apr 29, 1986

N021262 001

Mar 16, 2001

A076439
N021764
A076254
A076260
A078075

Mar
May
Sep
May
Jan

BRIMONIDINE TARTRATE

AT
AT
AT
AT
AT
AT
XX

SOLUTION/DROPS; OPHTHALMIC
ALPHAGAN P
+ ALLERGAN
0.15%
BRIMONIDINE TARTRATE
AKORN
0.2%
ALCON PHARMS LTD
0.15%
0.2%
+ BAUSCH AND LOMB
0.2%
SANDOZ
0.2%
ALPHAGAN P
+ ALLERGAN
0.1%

001
001
001
001
001

14,
22,
16,
28,
30,

2006
2006
2003
2003
2008

N021770 001

Aug 19, 2005

N021398 001

Oct 30, 2007

N020816 001

Apr 01, 1998

N021664 002

Oct 16, 2010

A201211 001

May 11, 2011

EQ 5MG BASE
EQ 5MG BASE

A077226 001
A078899 001

Apr 04, 2005

Jul 30, 2008

EQ 5MG BASE

N017962 002

Mar 01, 1982

EQ 2.5MG BASE
EQ 2.5MG BASE
EQ 2.5MG BASE

A074631 001
A076962 001
A077646 001

Jan 13, 1998

Sep 24, 2004
Oct 01, 2008

EQ 2.5MG BASE

N017962 001

EQ 0.8MG BASE

N020866 001

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

SOLUTION/DROPS; OPHTHALMIC

COMBIGAN

0.2%;0.5%
XX + ALLERGAN

BRINZOLAMIDE
SUSPENSION/DROPS; OPHTHALMIC

AZOPT

XX + ALCON PHARMS LTD

1%

BROMFENAC SODIUM
SOLUTION/DROPS; OPHTHALMIC

BROMDAY

0.09%
XX + ISTA PHARMS INC
BROMFENAC SODIUM
COASTAL PHARMS
0.09%
XX

BROMOCRIPTINE MESYLATE
CAPSULE; ORAL
BROMOCRIPTINE MESYLATE
MYLAN
AB
ZYDUS PHARMS USA INC
AB
PARLODEL
AB + NOVARTIS

AB
AB
AB
AB
XX

TABLET; ORAL
BROMOCRIPTINE MESYLATE
LEK PHARMS
MYLAN
PADDOCK LLC
PARLODEL
+ NOVARTIS
CYCLOSET
+ VEROSCIENCE

May 05, 2009

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SYRUP; ORAL

BROMFED-DM

XX + WOCKHARDT

2MG/5ML;10MG/5ML;30MG/5ML

A088811 001

Jun 07, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 59 (of 424)

BUDESONIDE
CAPSULE; ORAL
BUDESONIDE
MYLAN
AB
ENTOCORT EC
AB + ASTRAZENECA

3MG

A090410 001

May 16, 2011

3MG

N021324 001

Oct 02, 2001

POWDER, METERED; INHALATION

PULMICORT

0.16MG/INH
XX + ASTRAZENECA
PULMICORT FLEXHALER
ASTRAZENECA
0.08MG/INH
XX
0.16MG/INH
XX +

N020441 002

Jun 24, 1997

N021949 001
N021949 002

Jul 12, 2006

Jul 12, 2006

SPRAY, METERED; NASAL

RHINOCORT

XX + ASTRAZENECA

0.032MG/INH

N020746 001

Oct 01, 1999

0.25MG/2ML
0.5MG/2ML
0.25MG/2ML
0.5MG/2ML

A078202
A078202
A077519
A077519

Mar
Mar
Nov
Nov

0.25MG/2ML
0.5MG/2ML

N020929 001
N020929 002

Aug 08, 2000

Aug 08, 2000

1MG/2ML

N020929 003

Aug 08, 2000

N021929 001
N021929 002

Jul 21, 2006

Jul 21, 2006

SUSPENSION; INHALATION
BUDESONIDE
APOTEX
AN
AN
TEVA PARENTERAL
AN
AN
PULMICORT RESPULES
ASTRAZENECA
AN
AN
PULMICORT RESPULES
XX + ASTRAZENECA

001
002
001
002

30,
30,
18,
18,

2009
2009
2008
2008

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

SPRAY, METERED; INHALATION

SYMBICORT

0.08MG/INH;0.0045MG/INH
XX + ASTRAZENECA
0.16MG/INH;0.0045MG/INH
XX +

BUMETANIDE
INJECTABLE; INJECTION
BUMETANIDE
BAXTER HLTHCARE
AP
AP + BEDFORD
HOSPIRA
AP

0.25MG/ML
0.25MG/ML
0.25MG/ML

A079196 001
A074441 001
A074332 001

Apr 30, 2008

Jan 27, 1995
Oct 31, 1994

TABLET; ORAL
BUMETANIDE
IVAX SUB TEVA PHARMS
AB
AB
AB
SANDOZ
AB
AB
AB +

0.5MG
1MG
2MG
0.5MG
1MG
2MG

A074225
A074225
A074225
A074700
A074700
A074700

Apr
Apr
Apr
Nov
Nov
Nov

001
002
003
001
002
003

24,
24,
24,
21,
21,
21,

1995
1995
1995
1996
1996
1996

BUPIVACAINE
INJECTABLE, LIPOSOMAL; INJECTION

EXPAREL

133MG/10ML (13.3MG/ML)
XX + PACIRA PHARMS INC
266MG/20ML (13.3MG/ML)
XX +

N022496 001
N022496 002

Oct 28, 2011

Oct 28, 2011

A070583 001
A070586 001

Feb 17, 1987

Mar 03, 1987

BUPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION
BUPIVACAINE HYDROCHLORIDE
HOSPIRA
AP
0.25%
AP
0.25%

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 60 (of 424)

BUPIVACAINE HYDROCHLORIDE

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
AP

INJECTABLE; INJECTION
BUPIVACAINE HYDROCHLORIDE
HOSPIRA
0.25%
0.25%
0.5%
0.5%
0.5%
0.5%
0.75%
0.75%
0.75%
SAGENT STRIDES
0.25%
0.5%
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
INTL MEDICATED
0.25%
0.5%
0.75%
SAGENT STRIDES
0.25%
0.5%
0.75%
MARCAINE HYDROCHLORIDE
+ HOSPIRA
0.25%
+
0.5%
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
+ HOSPIRA
0.25%
+
0.5%
+
0.75%
SENSORCAINE
APP PHARMS
0.25%
0.25%
0.5%
0.5%
0.75%
0.75%

INJECTABLE; SPINAL
BUPIVACAINE HYDROCHLORIDE
HOSPIRA
0.75%
AP
MARCAINE
AP + HOSPIRA
0.75%
SENSORCAINE
APP PHARMS
AP
0.75%

Feb 17, 1987

A070590
N018053
A070584
A070597
A070609
N018053
A070585
A070587
N018053
A091503
A091503

001
002
001
001
001
001
001
001
003
001
002

Oct 18, 2011

Oct 18, 2011

A076012
A076012
A076012
A091487
A091487
A091487

001
002
003
002
001
003

Jan
Jan
Jan
Oct
Oct
Oct

Feb 17, 1986

Mar 03, 1987
Mar 03, 1987
Mar 03, 1987
Mar 03, 1987

09,
09,
09,
18,
18,
18,

2002
2002
2002
2011
2011
2011

N016964 001
N016964 006
N016964 012
N016964 005
N016964 009
A070552
N018304
A070553
N018304
A070554
N018304

001
001
001
002
001
003

May 21, 1986

May 21, 1986
May 21, 1986

A071810 001

Dec 11, 1987

N018692 001

May 04, 1984

A071202 001

Apr 15, 1987

A071168 001
A071170 001

Jun 16, 1988

Jun 16, 1988

A071165 001
A071167 001

Jun 16, 1988

Jun 16, 1988

A077250 001

Sep 27, 2006

N022046 001

Jul 13, 1983

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

AP
AP
XX
XX

INJECTABLE; INJECTION
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
+ HOSPIRA
0.5%;0.005MG/ML
0.5%;0.005MG/ML
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
+ HOSPIRA
0.25%;0.005MG/ML
0.25%;0.005MG/ML

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

INJECTABLE; INJECTION
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
SEPTODONT
AP
0.5%;0.0091MG/ML
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE
AP + HOSPIRA
0.5%;0.0091MG/ML
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
AP + HOSPIRA
0.25%;0.0091MG/ML

N016964 004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 61 (of 424)

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
+ HOSPIRA
0.5%;0.0091MG/ML
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
+ HOSPIRA
0.25%;0.0091MG/ML
+
0.5%;0.0091MG/ML
+
0.75%;0.0091MG/ML
SENSORCAINE
APP PHARMS
0.25%;0.0091MG/ML
0.25%;0.0091MG/ML
0.5%;0.0091MG/ML
0.5%;0.0091MG/ML
0.75%;0.0091MG/ML

N016964 008
N016964 013
N016964 007
N016964 010
A070966
A070967
A070968
N018304
N018304

001
001
001
004
005

Oct
Oct
Oct
Sep
Sep

13,
13,
13,
02,
02,

1987
1987
1987
1983
1983

BUPRENORPHINE
FILM, EXTENDED RELEASE; TRANSDERMAL

BUTRANS

PURDUE PHARMA LP
5MCG/HR

XX
10MCG/HR

XX
20MCG/HR
XX +

N021306 001
N021306 002
N021306 003

Jun 30, 2010

Jun 30, 2010
Jun 30, 2010

BUPRENORPHINE HYDROCHLORIDE

AP
AP
AP
AP

AB
AB
AB
AB
AB
AB
AB
AB

INJECTABLE; INJECTION
BUPRENEX
+ RECKITT BENCKISER
EQ 0.3MG
BUPRENORPHINE HYDROCHLORIDE
BEDFORD
EQ 0.3MG
HOSPIRA
EQ 0.3MG
LUITPOLD
EQ 0.3MG

BASE/ML

N018401 001

BASE/ML
BASE/ML
BASE/ML

A076931 001
A074137 001
A078331 001

Mar 02, 2005

Jun 03, 1996
Mar 27, 2007

BASE
BASE
BASE
BASE
BASE
BASE

A090360
A090360
A090622
A090622
A078633
A078633

May
May
Sep
Sep
Oct
Oct

BASE
BASE

N020732 002
N020732 003

Oct 08, 2002

Oct 08, 2002

2MG;0.5MG
8MG;2MG

N020733 001
N020733 002

Oct 08, 2002

Oct 08, 2002

2MG;0.5MG
8MG;2MG

N022410 001
N022410 002

Aug 30, 2010

Aug 30, 2010

N022108 001
N022108 002

Apr 23, 2008

Apr 23, 2008

TABLET; SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE
BARR
EQ 2MG
EQ 8MG
ETHYPHARM
EQ 2MG
EQ 8MG
ROXANE
EQ 2MG
EQ 8MG
SUBUTEX
RECKITT BENCKISER
EQ 2MG
+
EQ 8MG

001
002
001
002
001
002

07,
07,
24,
24,
08,
08,

2010
2010
2010
2010
2009
2009

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

TABLET; SUBLINGUAL
SUBOXONE
RECKITT BENCKISER
XX
XX +

BUPRENORPHINE; NALOXONE
FILM; SUBLINGUAL
SUBOXONE
RECKITT BENCKISER
XX
XX +

BUPROPION HYDROBROMIDE
TABLET, EXTENDED RELEASE; ORAL
APLENZIN
VALEANT INTL
174MG
XX
348MG
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 62 (of 424)

BUPROPION HYDROBROMIDE
TABLET, EXTENDED RELEASE; ORAL
APLENZIN
VALEANT INTL
522MG
XX

N022108 003

Apr 23, 2008

A076143
A076143
A075491
A075491
A075584
A075584
A075310
A075310

Jan
Jan
Apr
Apr
Feb
Feb
Nov
Nov

BUPROPION HYDROCHLORIDE
TABLET; ORAL
BUPROPION HYDROCHLORIDE
APOTEX INC
AB
75MG
AB
100MG
MYLAN
AB
75MG
AB
100MG
SANDOZ
AB
75MG
AB
100MG
TEVA
AB
75MG
AB
100MG
WELLBUTRIN
GLAXOSMITHKLINE
AB
75MG
AB +
100MG
TABLET, EXTENDED RELEASE;
BUPROPION HYDROCHLORIDE
ACTAVIS
AB1
AB1
AB1
ANCHEN PHARMS
AB1
AB1
AB1
IMPAX LABS
AB1
AB1
AB1
MYLAN
AB1
AB1
AB1
SANDOZ
AB1
AB1
AB1
SUN PHARMA GLOBAL
AB1
AB1
AB1
WATSON LABS FLORIDA
AB1
AB1
AB1
WELLBUTRIN SR
GLAXOSMITHKLINE
AB1
AB1 +
AB1
BUPROPION HYDROCHLORIDE
ACTAVIS
AB2
ANCHEN PHARMS
AB2
IMPAX LABS
AB2
MYLAN
AB2
WATSON LABS FLORIDA
AB2
ZYBAN
AB2 + GLAXOSMITHKLINE
BUPROPION HYDROCHLORIDE
ACTAVIS
AB3
AB3
ANCHEN PHARMS
AB3
AB3
IMPAX LABS
AB3

001
002
001
002
001
002
001
002

17,
17,
17,
17,
07,
07,
29,
29,

2006
2006
2000
2000
2000
2000
1999
1999

N018644 002
N018644 003

Dec 30, 1985

Dec 30, 1985

100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG
100MG
150MG
200MG

A077455
A077455
A077455
A091459
A091459
A091459
A075913
A075913
A076711
A090325
A090325
A090325
A075932
A075932
A075932
A078866
A078866
A078866
A079095
A079095
A079095

Jul
Mar
Jul
Jun
Jun
Jun
Jan
Mar
Dec
Apr
Apr
Apr
Nov
Mar
Jun
Apr
Apr
Apr
Mar
Mar
Mar

100MG
150MG
200MG

N020358 002
N020358 003
N020358 004

Oct 04, 1996

Oct 04, 1996
Jun 14, 2002

150MG
150MG
150MG
150MG
150MG

A077475
A091520
A075914
A090941
A079094

Mar
Jun
May
May
Mar

150MG

N020711 003

May 14, 1997

150MG
300MG
150MG
300MG
150MG

A077285
A077285
A077284
A077284
A077415

Nov
Aug
Dec
Dec
Nov

ORAL
001
002
003
001
002
003
001
002
001
001
002
003
001
002
003
001
002
003
001
002
003

001
001
001
001
001

001
002
001
002
001

19,
12,
19,
09,
09,
09,
28,
22,
03,
08,
08,
08,
25,
22,
22,
06,
06,
06,
24,
24,
24,

12,
09,
27,
03,
24,

26,
15,
14,
14,
26,

2010
2008
2010
2011
2011
2011
2004
2004
2004
2010
2010
2010
2003
2004
2005
2010
2010
2010
2009
2009
2009

2008
2011
2004
2010
2009

2008
2008
2006
2006
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 63 (of 424)

BUPROPION HYDROCHLORIDE
TABLET, EXTENDED RELEASE;
BUPROPION HYDROCHLORIDE
IMPAX LABS
AB3
MYLAN
AB3
AB3
WATSON LABS
AB3
AB3
WELLBUTRIN XL
AB3 + VALEANT INTL
AB3
FORFIVO XL
XX + INTELGENX CORP

ORAL
002
001
002
001
002

Dec
Jul
Jul
Nov
Jun

15,
14,
14,
26,
13,

2006
2010
2010
2008
2007

300MG
150MG
300MG
150MG
300MG

A077415
A090942
A090942
A077715
A077715

150MG
300MG

N021515 001
N021515 002

Aug 28, 2003

Aug 28, 2003

450MG

N022497 001

Nov 10, 2011

A075521
A075521
A075521
A078246
A078246
A078246
A078246
A075119
A075119
A075119
A075272
A075467
A075467
A075272
A075467
A075272
A075467
A076008
A075572
A075572
A075572
A075022
A075022
A075022
A075022
A074253
A074253
A074253

Apr
Apr
Apr
Feb
Feb
Feb
Feb
Mar
Mar
Jan
Mar
Feb
Mar
Mar
Feb
Mar
Feb
Jun
Feb
Feb
Feb
Feb
Feb
Feb
Mar
Mar
Mar
Mar

BUSPIRONE HYDROCHLORIDE
TABLET; ORAL
BUSPIRONE HYDROCHLORIDE
APOTEX
AB
5MG
AB
10MG
AB
15MG
DR REDDYS LABS LTD
AB
5MG
AB
10MG
AB
15MG
AB
30MG
EGIS
AB
5MG
AB
10MG
AB
15MG
MYLAN
AB
5MG
AB
5MG
AB
7.5MG
AB
10MG
AB
10MG
AB
15MG
AB
15MG
AB
30MG
NESHER PHARMS
AB
5MG
AB
10MG
AB
15MG
TEVA
AB
5MG
AB
10MG
AB +
15MG
AB
30MG
WATSON LABS
AB
5MG
AB
10MG
AB
15MG

001
002
003
001
002
003
004
001
002
003
001
001
002
002
003
003
004
001
001
002
003
001
002
003
004
001
002
003

05,
05,
05,
27,
27,
27,
27,
14,
14,
23,
01,
28,
28,
01,
28,
28,
28,
28,
27,
27,
27,
28,
28,
28,
25,
28,
28,
13,

2002
2002
2002
2009
2009
2009
2009
2002
2002
2003
2002
2002
2001
2002
2002
2001
2002
2001
2002
2002
2002
2002
2002
2002
2004
2001
2001
2002

BUSULFAN
INJECTABLE; INJECTION

BUSULFEX

XX + OTSUKA PHARM

6MG/ML

N020954 001

TABLET; ORAL

MYLERAN

XX + ASPEN GLOBAL

2MG

N009386 001

30MG/5ML

A085380 001

BUTABARBITAL SODIUM
ELIXIR; ORAL

BUTISOL SODIUM

XX + MEDA PHARMS

Feb 04, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 64 (of 424)

BUTABARBITAL SODIUM
TABLET; ORAL

BUTISOL SODIUM

XX + MEDA PHARMS
XX +

30MG
50MG

N000793 004
N000793 003

1%

N020524 001

Oct 18, 1996

1%

N021408 001

Oct 17, 2002

2%

N019881 001

Feb 07, 1997

A075046
A075697
A078400
A078247
A078400

001
001
001
001
002

Aug
Oct
May
Apr
May

12,
23,
01,
29,
01,

1998
2001
2009
2009
2009

A075045
A075045
A075695
A075695
A074626
A074626

001
002
001
002
001
002

Aug
Aug
Oct
Oct
Jan
Jan

12,
12,
23,
23,
23,
23,

1998
1998
2001
2001
1997
1997

BUTENAFINE HYDROCHLORIDE
CREAM; TOPICAL

MENTAX

XX + MYLAN
MENTAX-TC
XX + MYLAN

BUTOCONAZOLE NITRATE
CREAM; VAGINAL

GYNAZOLE-1

XX + KV PHARM

BUTORPHANOL TARTRATE
INJECTABLE; INJECTION
BUTORPHANOL TARTRATE
BEDFORD
AP
2MG/ML
CLARIS LIFESCIENCES
AP
2MG/ML
HIKMA FARMACEUTICA
AP
1MG/ML
AP
2MG/ML
AP
2MG/ML
BUTORPHANOL TARTRATE PRESERVATIVE FREE
BEDFORD
AP
1MG/ML
AP
2MG/ML
CLARIS LIFESCIENCES
AP
1MG/ML
AP
2MG/ML
HOSPIRA
AP
1MG/ML
AP
2MG/ML
STADOL
AP + APOTHECON
2MG/ML
STADOL PRESERVATIVE FREE
AP + APOTHECON
1MG/ML
AP +
2MG/ML

N017857 001
N017857 002

SPRAY, METERED; NASAL

BUTORPHANOL TARTRATE
AB + MYLAN
NOVEX
AB
ROXANE
AB

1MG/SPRAY
1MG/SPRAY
1MG/SPRAY

A075759 001
A075499 001
A075824 001

Aug 08, 2001

Dec 04, 2002
Mar 12, 2002

60MG/1.5ML (40MG/ML)

N201023 001

Jun 17, 2010

0.5MG
0.5MG
0.5MG
0.5MG

A077843
A077750
A076310
A078035

Jul
Mar
Dec
Apr

N017857 004

CABAZITAXEL
SOLUTION; IV (INFUSION)

JEVTANA KIT

XX + SANOFI AVENTIS US

CABERGOLINE

AB
AB
AB
AB

TABLET; ORAL
CABERGOLINE
IMPAX LABS INC
IVAX SUB TEVA PHARMS
+ PAR PHARM
WATSON LABS

001
001
001
001

03,
07,
29,
21,

2007
2007
2005
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 65 (of 424)

CAFFEINE CITRATE

AP
AP
AP
AP
AP

AA
AA
AA
AA
AA

SOLUTION; INTRAVENOUS
CAFCIT
+ MEAD JOHNSON
CAFFEINE CITRATE
APP PHARMS
LUITPOLD
PADDOCK LLC
SUN PHARMA GLOBAL
SOLUTION; ORAL
CAFCIT
+ MEAD JOHNSON
CAFFEINE CITRATE
APP PHARMS
LUITPOLD
PADDOCK LLC
SUN PHARMA GLOBAL

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

N020793 001

Sep 21, 1999

EQ
EQ
EQ
EQ

A077997
A077906
A077233
A090077

Jul
May
Sep
Sep

30MG
30MG
30MG
30MG

BASE/3ML
BASE/3ML
BASE/3ML
BASE/3ML

(EQ
(EQ
(EQ
(EQ

10MG
10MG
10MG
10MG

BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)

001
001
001
001

20,
15,
21,
30,

2007
2007
2006
2009

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

N020793 002

Apr 12, 2000

EQ
EQ
EQ
EQ

A078002
A090064
A077304
A090357

Jan
Nov
Sep
Sep

30MG
30MG
30MG
30MG

BASE/3ML
BASE/3ML
BASE/3ML
BASE/3ML

(EQ
(EQ
(EQ
(EQ

10MG
10MG
10MG
10MG

BASE/ML)
BASE/ML)
BASE/ML)
BASE/ML)

001
001
001
001

31,
20,
21,
30,

2008
2009
2006
2009

CAFFEINE; ERGOTAMINE TARTRATE

SUPPOSITORY; RECTAL

MIGERGOT

XX + G AND W LABS

100MG;2MG

TABLET; ORAL
CAFERGOT
AA + SANDOZ
100MG;1MG
ERGOTAMINE TARTRATE AND CAFFEINE
MIKART
AA
100MG;1MG
WEST WARD
AA
100MG;1MG

A086557 001

Oct 04, 1983

A084294 001
A040590 001
A040510 001

Sep 16, 2005

Sep 17, 2004

CALCIPOTRIENE
AEROSOL, FOAM; TOPICAL

SORILUX

XX + STIEFEL LABS INC

0.005%

N022563 001

Oct 06, 2010

CREAM; TOPICAL

DOVONEX

XX + LEO PHARM

0.005%

N020554 001

Jul 22, 1996

OINTMENT; TOPICAL

CALCIPOTRIENE

XX + GLENMARK GENERICS

0.005%

A090633 001

Mar 24, 2010

0.005%
0.005%
0.005%
0.005%

A078468
A077579
A078305
A077029

Mar
Nov
May
Nov

0.005%

N020611 001

Mar 03, 1997

200 IU/ML

N017808 002

Mar 29, 1991

200 IU/SPRAY
200 IU/SPRAY

A076396 001
A076979 001

Nov 17, 2008

Jun 08, 2009

200 IU/SPRAY

N020313 002

Aug 17, 1995

AT
AT
AT
AT
AT

SOLUTION; TOPICAL
CALCIPOTRIENE
G AND W LABS INC
HI TECH PHARMA
NYCOMED US
TOLMAR
DOVONEX
+ LEO PHARM

001
001
001
001

24,
19,
06,
20,

2011
2009
2008
2009

CALCITONIN SALMON
INJECTABLE; INJECTION

MIACALCIN

XX + NOVARTIS
SPRAY, METERED; NASAL
CALCITONIN-SALMON
APOTEX INC
AB
PAR PHARM
AB
MIACALCIN
AB + NOVARTIS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 66 (of 424)

CALCITONIN SALMON RECOMBINANT

SPRAY, METERED; NASAL

FORTICAL

XX + UPSHER SMITH

200 IU/SPRAY

N021406 001

Aug 12, 2005

0.25MCG
0.25MCG
0.5MCG

A076917 001
A075765 001
A075765 002

Mar 27, 2006

Oct 12, 2001
Oct 12, 2001

0.25MCG
0.5MCG

N018044 001
N018044 002

CALCITRIOL
CAPSULE; ORAL
CALCITRIOL
ROXANE
AB
TEVA
AB
AB
ROCALTROL
VALIDUS PHARMS
AB
AB +
INJECTABLE; INJECTION
CALCIJEX
AP + ABBOTT
AP +
CALCITRIOL
AKORN
AP
AP
APP PHARMS
AP
AP
FRESENIUS MEDCL
AP
AP
LUITPOLD
AP
AP
ROCKWELL MEDCL
AP
SAGENT PHARMS
AP
TEVA PARENTERAL
AP

0.001MG/ML
0.002MG/ML

N018874 001
N018874 002

Sep 25, 1986

Sep 25, 1986

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

A078066
A078066
A075836
A075836
A075766
A075766
A075746
A075746
A076206
A077102
A075823

Jan
Jan
Dec
Dec
Feb
Feb
Sep
Sep
Sep
Feb
Mar

OINTMENT; TOPICAL

VECTICAL

XX + GALDERMA LABS LP

3MCG/GM

N022087 001

Jan 23, 2009

1MCG/ML

A076242 001

Jul 18, 2003

1MCG/ML

N021068 001

Nov 20, 1998

SOLUTION; ORAL
CALCITRIOL
ROXANE
AA
ROCALTROL
AA + VALIDUS PHARMS

001
002
001
002
001
002
001
002
001
001
002

29,
29,
31,
31,
20,
20,
26,
26,
17,
08,
31,

2008
2008
2002
2002
2003
2003
2003
2003
2003
2006
2003

CALCIUM ACETATE
CAPSULE; ORAL
CALCIUM ACETATE
ROXANE
AB
PHOSLO GELCAPS
AB + FRESENIUS MEDCL

EQ 169MG CALCIUM

A077728 001

Feb 26, 2008

EQ 169MG CALCIUM

N021160 003

Apr 02, 2001

SOLUTION; ORAL

PHOSLYRA

XX + FRESENIUS MEDCL

EQ 169MG CALCIUM/5ML

N022581 001

Apr 18, 2011

EQ 169MG CALCIUM

A091561 001

Apr 13, 2011

EQ 169MG CALCIUM

A078502 001

Nov 25, 2008

N021117 001

Jan 28, 2000

TABLET; ORAL
CALCIUM ACETATE
PADDOCK LLC
AB
ELIPHOS
AB + CYPRESS PHARM

CALCIUM CHLORIDE
INJECTABLE; INJECTION

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER

100MG/ML
XX + HOSPIRA

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 67 (of 424)

CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM

CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
SOLUTION; IRRIGATION
BSS PLUS
AT + ALCON

AT

ENDOSOL EXTRA
+ AKORN

0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L

N018469 001

0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L

N020079 001

Nov 27, 1991

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;

SODIUM BICARBONATE; SODIUM CHLORIDE
INJECTABLE; INJECTION

PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER

N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0
XX + GAMBRO RENAL PRODS
5GM/1000ML;0.157GM/1000ML;2.21GM/1000ML
;7.07GM/1000ML
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0
XX + GAMBRO RENAL PRODS
5GM/1000ML;0.314GM/1000ML;2.21GM/1000ML
;7.07GM/1000ML
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
XX + GAMBRO RENAL PRODS
3.05GM/1000ML;0.314GM/1000ML;2.21GM/100
0ML;7.07GM/1000ML
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
XX + GAMBRO RENAL PRODS
3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;
6.46GM/1000ML
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.0
XX + GAMBRO RENAL PRODS
3GM/1000ML;0.157GM/1000ML;3.09GM/1000ML
;6.46GM/1000ML
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;
XX + GAMBRO RENAL PRODS
2.03GM/1000ML;0.157GM/1000ML;3.09GM/100
0ML;6.46GM/1000ML
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.4
XX + GAMBRO RENAL PRODS
4GM/1000ML;0.314GM/1000ML;3.09GM/1000ML
;6.46GM/1000ML
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
XX + GAMBRO RENAL PRODS
3.05GM/1000ML;0.314GM/1000ML;3.09GM/100
0ML;6.46GM/1000ML
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44
XX + GAMBRO RENAL PRODS
GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46
GM/1000ML
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2
XX + GAMBRO RENAL PRODS
.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

XX + ALCON PHARMS LTD

0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/M
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L

N022193 001

Jul 24, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 68 (of 424)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;

SODIUM CHLORIDE
INJECTABLE; INJECTION

ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER

37MG/100ML;5GM/100ML;31MG/100ML;120MG/1
XX + B BRAUN
00ML;330MG/100ML;88MG/100ML

N019864 001

Jun 10, 1993

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;

SODIUM CHLORIDE; SODIUM CITRATE
INJECTABLE; INJECTION

ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER

XX + B BRAUN
35MG/100ML;5GM/100ML;30MG/100ML;74MG/10
0ML;640MG/100ML;500MG/100ML;74MG/100ML

N019867 001

Dec 20, 1993

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;

SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE; INJECTION

PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER

37MG/100ML;5GM/100ML;30MG/100ML;119MG/1
XX + BAXTER HLTHCARE
00ML;161MG/100ML;94MG/100ML;138MG/100ML

N017390 001

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

XX
XX

XX
XX

SOLUTION; INTRAPERITONEAL

DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER

+ B BRAUN
510MG/100ML;30GM/100ML;200MG/100ML;9.4G
M/100ML;11GM/100ML
+
510MG/100ML;30GM/100ML;200MG/100ML;9.2G
M/100ML;9.6GM/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 003

Aug 26, 1983

N018807 001

Aug 26, 1983

N018807 002

Aug 26, 1983

N018807 004

Aug 26, 1983

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

AT
AT

AT

AT

AT
AT

AT

AT

AT

SOLUTION; INTRAPERITONEAL
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N018379
67MG/100ML;392MG/100ML
25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N018883
67MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N018883
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
FRESENIUS MEDCL
18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020171
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N018379
67MG/100ML;392MG/100ML
25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N018883
67MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N018883
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
FRESENIUS MEDCL
18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020171
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5 N018379
67MG/100ML;392MG/100ML

002
001

Nov 30, 1984

004

Nov 30, 1984

001

Aug 19, 1992

003
002

Nov 30, 1984

005

Nov 30, 1984

002

Aug 19, 1992

007

Jun 24, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 69 (of 424)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

AT
AT

AT

AT

AT

AT

AT

AT

AT

AT

AT

AT

AT

AT

AT

AT

AT
AT

AT
AT

AT

AT

SOLUTION; INTRAPERITONEAL
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N018379
567MG/100ML;392MG/100ML
25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N018883
567MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N018883
538MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
FRESENIUS MEDCL
18.4MG/100ML;4.25GM/100ML;5.08MG/100ML; N020171
538MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N018379
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N018379
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5 N018379
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N018379
538MG/100ML;448MG/100ML
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N017512
67MG/100ML;392MG/100ML
DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N017512
67MG/100ML;392MG/100ML
DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
BAXTER HLTHCARE
25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N017512
567MG/100ML;392MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020183
38MG/100ML;448MG/100ML
DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N017512
67MG/100ML;392MG/100ML
DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N017512
67MG/100ML;392MG/100ML
DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5 N017512
67MG/100ML;392MG/100ML
DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
BAXTER HLTHCARE
25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N017512
567MG/100ML;392MG/100ML
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N017512
38MG/100ML;448MG/100ML
25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020163
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N017512
38MG/100ML;448MG/100ML
25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020163
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5 N017512
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
BAXTER HLTHCARE
25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N017512
538MG/100ML;448MG/100ML

001
003

Nov 30, 1984

006

Nov 30, 1984

003

Aug 19, 1992

004

Jul 07, 1982

005

Jul 07, 1982

008

Jun 24, 1988

006

Jul 07, 1982

001

003

002

001

Dec 04, 1992

007

Jul 09, 1984

008

Jul 09, 1984

010

Nov 18, 1985

009

Jul 09, 1984

004
001

Dec 04, 1992

005
002

Dec 04, 1992

011

Nov 18, 1985

006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 70 (of 424)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

AT

AT

AT

AT

XX

XX

XX

XX

XX

XX

XX

SOLUTION; INTRAPERITONEAL
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
BAXTER HLTHCARE
25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;
538MG/100ML;448MG/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 4.25% IN PLASTIC CONTAINER
FRESENIUS
18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;
538MG/100ML;448MG/100ML
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER
B BRAUN
26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/
100ML;450MG/100ML
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN
26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/
100ML;450MG/100ML
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
B BRAUN
26MG/100ML;4.25GM/100ML;5MG/100ML;530MG
/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
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
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;
538MG/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

N020163 003

Dec 04, 1992

N020374 001

Jun 13, 1994

N020374 002

Jun 13, 1994

N020374 004

Jun 13, 1994

N018460 007

Jan 29, 1986

N018460 005

Nov 02, 1983

N018460 009

Jan 29, 1986

N020183 002

Dec 04, 1992

N020183 003

Dec 04, 1992

N020183 004

Dec 04, 1992

N020374 003

Jun 13, 1994

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM

BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INTRATHECAL

ELLIOTTS B SOLUTION

XX + QOL MEDCL

0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9
MG/ML;7.3MG/ML;0.2MG/ML

N020577 001

Sep 27, 1996

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION

DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER

20MG/100ML;5GM/100ML;30MG/100ML;380MG/1
XX + B BRAUN
00ML;600MG/100ML

N018258 001

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE; INJECTION
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER
HOSPIRA
AP
33MG/100ML;5GM/100ML;30MG/100ML;860MG/1
00ML
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
B BRAUN
AP
33MG/100ML;5GM/100ML;30MG/100ML;860MG/1
00ML
BAXTER HLTHCARE
AP
33MG/100ML;5GM/100ML;30MG/100ML;860MG/1
00ML

N018254 001

N020000 001
N016695 001

Apr 17, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 71 (of 424)

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

AP

AP

AP

AP

AP
AP
AP
AP

AP

AP
AP

XX

XX
XX

XX

INJECTABLE; INJECTION
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA
20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N017608 001
00ML;310MG/100ML
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN
Feb
20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N019634 003
00ML;310MG/100ML
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
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
BAXTER HLTHCARE
Apr
20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 006
100ML;310MG/100ML
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
BAXTER HLTHCARE
Apr
20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 004
100ML;310MG/100ML
Apr
20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 005
100ML;310MG/100ML
HOSPIRA
Oct
20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019685 002
100ML;310MG/100ML
Oct
20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 008
100ML;310MG/100ML
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
BAXTER HLTHCARE
Apr
20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 007
100ML;310MG/100ML
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
BAXTER HLTHCARE
Apr
20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 008
100ML;310MG/100ML
HOSPIRA
Oct
20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 004
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
/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
100ML;310MG/100ML
20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 003
Apr
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
100ML;310MG/100ML

24, 1988

05, 1985

05, 1985
05, 1985
17, 1988
17, 1988

05, 1985

05, 1985
17, 1988

24, 1988

05, 1985
05, 1985

05, 1985

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM

CHLORIDE
INJECTABLE; INJECTION

TPN ELECTROLYTES IN PLASTIC CONTAINER

16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;
XX + HOSPIRA
16.1MG/ML

N018895 001

Jul 20, 1984

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM

CHLORIDE; SODIUM CITRATE
INJECTABLE; INJECTION

ISOLYTE E IN PLASTIC CONTAINER

35MG/100ML;30MG/100ML;74MG/100ML;640MG/
XX + B BRAUN
100ML;500MG/100ML;74MG/100ML
SOLUTION; IRRIGATION
BALANCED SALT
AKORN
AT
AT

B BRAUN

0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6
.4MG/ML;1.7MG/ML
0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6
.4MG/ML;1.7MG/ML

N019718 001

Sep 29, 1989

A075503 001

Sep 27, 2006

A091387 001

Feb 03, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 72 (of 424)

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM

CHLORIDE; SODIUM CITRATE
SOLUTION; IRRIGATION
BSS
AT + ALCON

0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6
.4MG/ML;1.7MG/ML

N020742 001

Dec 10, 1997

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM

CHLORIDE; SODIUM LACTATE
INJECTABLE; INJECTION

PLASMA-LYTE R IN PLASTIC CONTAINER

XX + BAXTER HLTHCARE
36.8MG/100ML;30.5MG/100ML;74.6MG/100ML;
640MG/100ML;496MG/100ML;89.6MG/100ML

N017438 001

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

SOLUTION; PERFUSION, CARDIAC
CARDIOPLEGIC IN PLASTIC CONTAINER
BAXTER HLTHCARE
AT
17.6MG/100ML;325.3MG/100ML;119.3MG/100M
L;643MG/100ML
PLEGISOL IN PLASTIC CONTAINER
AT + HOSPIRA
17.6MG/100ML;325.3MG/100ML;119.3MG/100M
L;643MG/100ML

A075323 001

Apr 21, 2000

N018608 001

Feb 26, 1982

INJECTABLE; INJECTION
RINGER'S IN PLASTIC CONTAINER
B BRAUN
AP
33MG/100ML;30MG/100ML;860MG/100ML
BAXTER HLTHCARE
AP
33MG/100ML;30MG/100ML;860MG/100ML
HOSPIRA
AP
33MG/100ML;30MG/100ML;860MG/100ML

N020002 001
N016693 001
N018251 001

Apr 17, 1992

SOLUTION; IRRIGATION
RINGER'S IN PLASTIC CONTAINER
B BRAUN
AT
33MG/100ML;30MG/100ML;860MG/100ML
BAXTER HLTHCARE
AT
33MG/100ML;30MG/100ML;860MG/100ML
HOSPIRA
AT
33MG/100ML;30MG/100ML;860MG/100ML

N018156 001
N018495 001
N017635 001

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Feb 19, 1982

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE; INJECTION
LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN
AP
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML
BAXTER HLTHCARE
AP
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML
HOSPIRA
AP
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML
SOLUTION; IRRIGATION
LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN
AT
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML
BAXTER HLTHCARE
AT
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML
AT
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML
AT
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML
HOSPIRA
AT
20MG/100ML;30MG/100ML;600MG/100ML;310MG
/100ML

N019632 001

Feb 29, 1988

N016682 001
N017641 001

N018681 001

Dec 27, 1982

N018494 001

Feb 19, 1982

N018921 001

Apr 03, 1984

N019933 001

Aug 29, 1989

N019416 001

Jan 17, 1986

N020521 001

Jul 01, 1998

CALFACTANT
SUSPENSION; INTRATRACHEAL

INFASURF PRESERVATIVE FREE

35MG/ML
XX + ONY

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 73 (of 424)

CANDESARTAN CILEXETIL
TABLET; ORAL
ATACAND
ASTRAZENECA
XX
XX
XX
XX +

4MG
8MG
16MG
32MG

N020838
N020838
N020838
N020838

001
002
003
004

Jun
Jun
Jun
Jun

04,
04,
04,
04,

1998
1998
1998
1998

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

TABLET; ORAL
ATACAND HCT
ASTRAZENECA
XX
XX
XX +

16MG;12.5MG
32MG;12.5MG
32MG;25MG

N021093 001
N021093 002
N021093 003

Sep 05, 2000

Sep 05, 2000
May 16, 2008

150MG
500MG

N020896 001
N020896 002

Apr 30, 1998

Apr 30, 1998

EQ 1GM BASE/VIAL

N050095 001

8%

N022395 001

Nov 16, 2009

12.5MG
25MG
50MG
100MG

N018343
N018343
N018343
N018343

005
002
001
003

Jan 17, 1985

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

A074737
A074737
A074737
A074737
A074434
A074434
A074434
A074434
A074477
A074477
A074477
A074477
A074363
A074363
A074363
A074363
A074677
A074677
A074677
A074677

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
004
002
001
003

Oct
Oct
Oct
Oct
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Nov
Nov
Nov
Nov
May
May
May
May

CAPECITABINE
TABLET; ORAL
XELODA
HOFFMANN LA ROCHE
XX
XX +

CAPREOMYCIN SULFATE
INJECTABLE; INJECTION

CAPASTAT SULFATE

XX + AKORN

CAPSAICIN
PATCH; TOPICAL

QUTENZA

XX + NEUROGESX

CAPTOPRIL
TABLET; ORAL
CAPOTEN
PAR PHARM
AB
AB
AB
AB +
CAPTOPRIL
APOTEX
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
PRINSTON INC
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
STASON
AB
AB
AB
AB

28,
28,
28,
28,
13,
13,
13,
13,
13,
13,
13,
13,
09,
09,
09,
09,
30,
30,
30,
30,

1998
1998
1998
1998
1996
1996
1996
1996
1996
1996
1996
1996
1995
1995
1995
1995
1997
1997
1997
1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 74 (of 424)

CAPTOPRIL
TABLET; ORAL
CAPTOPRIL
TEVA
AB
AB
AB
AB
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
AB
AB
AB
AB
WEST WARD
AB
AB
AB
AB
WOCKHARDT
AB
AB
AB
AB

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

A074322
A074483
A074322
A074483
A074322
A074483
A074322
A074483
A074386
A074451
A074386
A074451
A074386
A074451
A074386
A074451
A074505
A074505
A074505
A074505
A074532
A074532
A074532
A074532

001
001
002
002
003
003
004
004
001
001
002
002
003
003
004
004
001
002
003
004
001
002
003
004

Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
May
Feb
May
Feb
May
Feb
May
Feb
Feb
Feb
Feb
Feb
Mar
Mar
Mar
Mar

13,
13,
13,
13,
13,
13,
13,
13,
23,
13,
23,
13,
23,
13,
23,
13,
13,
13,
13,
13,
28,
28,
28,
28,

1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1997
1997
1997
1997

CAPTOPRIL; HYDROCHLOROTHIAZIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
CAPOZIDE 25/15
APOTHECON
25MG;15MG
CAPOZIDE 25/25
+ APOTHECON
25MG;25MG
CAPOZIDE 50/15
+ APOTHECON
50MG;15MG
CAPOZIDE 50/25
APOTHECON
50MG;25MG
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
MYLAN
25MG;15MG
25MG;25MG
50MG;15MG
50MG;25MG
TEVA
25MG;15MG
25MG;25MG
50MG;15MG
50MG;25MG

N018709 001

Oct 12, 1984

N018709 002

Oct 12, 1984

N018709 004

Oct 12, 1984

N018709 003

Oct 12, 1984

A074896
A074896
A074896
A074896
A074827
A074827
A074827
A074827

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

29,
29,
29,
29,
29,
29,
29,
29,

1997
1997
1997
1997
1997
1997
1997
1997

Nov
Nov
Nov
May

25,
25,
25,
20,

2011
2011
2011
2011

001
002
004
003
001
002
004
003

CARBACHOL
SOLUTION; INTRAOCULAR

MIOSTAT

XX + ALCON

0.01%

N016968 001

CARBAMAZEPINE
CAPSULE, EXTENDED RELEASE; ORAL
CARBAMAZEPINE
APOTEX INC
AB
100MG
AB
200MG
AB
300MG
NOSTRUM
AB
100MG

A078986
A078986
A078986
A076697

001
002
003
001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 75 (of 424)

CARBAMAZEPINE
CAPSULE, EXTENDED RELEASE; ORAL
CARBAMAZEPINE
NOSTRUM
200MG
AB
300MG
AB
CARBATROL
SHIRE
100MG
AB
200MG
AB
300MG
AB +
EQUETRO
VALIDUS PHARMS INC
100MG
XX
200MG
XX
300MG
XX +
SUSPENSION; ORAL
CARBAMAZEPINE
WOCKHARDT
AB
TEGRETOL
AB + NOVARTIS
TERIL
TARO
AB

AB
AB
AB
AB
AB
XX
XX
XX

AB
AB
AB
AB
XX

TABLET; ORAL
CARBAMAZEPINE
APOTEX INC
TARO
TORRENT PHARMS
EPITOL
TEVA
TEGRETOL
+ NOVARTIS
CARBAMAZEPINE
TORRENT PHARMS

TABLET, CHEWABLE; ORAL

CARBAMAZEPINE
TARO PHARM INDS
TORRENT PHARMS
EPITOL
TEVA
TEGRETOL
+ NOVARTIS
CARBAMAZEPINE
+ TARO PHARM INDS

A076697 002
A076697 003

May 20, 2011

May 20, 2011

N020712 003
N020712 001
N020712 002

Sep 30, 1997

Sep 30, 1997
Sep 30, 1997

N021710 001
N021710 002
N021710 003

Dec 10, 2004

Dec 10, 2004
Dec 10, 2004

100MG/5ML

A075714 001

Jun 05, 2002

100MG/5ML

N018927 001

Dec 18, 1987

100MG/5ML

A076729 001

Sep 20, 2004

200MG
200MG
200MG

A075948 001
A074649 001
A077272 002

Feb 27, 2002

Oct 03, 1996
Dec 07, 2005

200MG

A070541 001

Sep 17, 1986

200MG

N016608 001

100MG
300MG
400MG

A077272 001
A077272 003
A077272 004

Dec 07, 2005

Dec 07, 2005
Dec 07, 2005

100MG
100MG

A075687 001
A075712 001

Oct 24, 2000

Jul 05, 2001

100MG

A073524 001

Jul 29, 1992

100MG

N018281 001

200MG

A075687 002

Jul 29, 2002

A078115 001
A078115 002
A078115 003

Mar 31, 2009

Mar 31, 2009
Mar 31, 2009

N020234 001
N020234 002
N020234 003

Mar 25, 1996

Mar 25, 1996
Mar 25, 1996

TABLET, EXTENDED RELEASE; ORAL

CARBAMAZEPINE
TARO
100MG
AB
200MG
AB
400MG
AB
TEGRETOL-XR
NOVARTIS
AB
100MG
AB
200MG
AB +
400MG

CARBIDOPA
TABLET; ORAL

LODOSYN

XX + ATON

25MG

N017830 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 76 (of 424)

CARBIDOPA; ENTACAPONE; LEVODOPA

XX
XX
XX
XX
XX
XX

TABLET; ORAL

STALEVO 100

ORION
STALEVO 125

ORION
STALEVO 150

ORION
STALEVO 200

+ ORION
STALEVO 50

+ ORION
STALEVO 75

ORION

25MG;200MG;100MG

N021485 002

Jun 11, 2003

31.25MG;200MG;125MG

N021485 006

Aug 29, 2008

37.5MG;200MG;150MG

N021485 003

Jun 11, 2003

50MG;200MG;200MG

N021485 004

Aug 02, 2007

12.5MG;200MG;50MG

N021485 001

Jun 11, 2003

18.75MG;200MG;75MG

N021485 005

Aug 29, 2008

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
25MG;250MG

A074260
A074260
A074260
A077120
A077120
A077120
A090324
A090324
A090324
A078536
A078536
A078536
A073618
A073589
A073607

Sep
Sep
Sep
Jun
Jun
Jun
Sep
Sep
Sep
Oct
Oct
Oct
Aug
Aug
Aug

03,
03,
03,
02,
02,
02,
28,
28,
28,
28,
28,
28,
28,
28,
28,

1993
1993
1993
2008
2008
2008
2009
2009
2009
2008
2008
2008
1992
1992
1992

10MG;100MG
25MG;100MG
25MG;250MG

N017555 001
N017555 003
N017555 002

Jun
Jun
May
May
Apr
Sep
Aug
Aug

16,
16,
14,
14,
21,
30,
23,
23,

2004
2004
2004
2004
2000
1999
2007
2007

CARBIDOPA; LEVODOPA
TABLET; ORAL
CARBIDOPA AND LEVODOPA
ACTAVIS ELIZABETH
AB
AB
AB
APOTEX INC
AB
AB
AB
MYLAN
AB
AB
AB
SUN PHARM INDS
AB
AB
AB
TEVA
AB
AB
AB
SINEMET
MERCK SHARP DOHME
AB
AB
AB +

TABLET, EXTENDED RELEASE; ORAL

CARBIDOPA AND LEVODOPA
APOTEX
AB
25MG;100MG
AB
50MG;200MG
IMPAX LABS
AB
25MG;100MG
AB
50MG;200MG
MYLAN
AB
25MG;100MG
AB
50MG;200MG
SUN PHARM INDS
AB
25MG;100MG
AB
50MG;200MG
SINEMET CR
MERCK SHARP DOHME
AB
25MG;100MG
AB +
50MG;200MG

AB
AB
AB
AB
AB
AB
AB
AB

TABLET, ORALLY DISINTEGRATING; ORAL

CARBIDOPA AND LEVODOPA
IMPAX LABS
10MG;100MG
25MG;100MG
25MG;250MG
MYLAN
10MG;100MG
25MG;100MG
25MG;250MG
SUN PHARM INDS
10MG;100MG
25MG;100MG

A076212
A076212
A076521
A076521
A075091
A075091
A077828
A077828

001
002
003
001
002
003
001
002
003
001
002
003
001
001
001

001
002
001
002
002
001
001
002

N019856 002
N019856 001

Dec 24, 1992

May 30, 1991

A090631
A090631
A090631
A078893
A078893
A078893
A078690
A078690

Jun
Jun
Jun
Sep
Sep
Sep
Jul
Jul

001
002
003
001
002
003
001
002

08,
08,
08,
18,
18,
18,
31,
31,

2010
2010
2010
2008
2008
2008
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 77 (of 424)

CARBIDOPA; LEVODOPA

AB
AB
AB
AB

TABLET, ORALLY DISINTEGRATING; ORAL

CARBIDOPA AND LEVODOPA
SUN PHARM INDS
25MG;250MG
PARCOPA
SCHWARZ PHARMA
10MG;100MG
25MG;100MG
+
25MG;250MG

A078690 003

Jul 31, 2009

A076699 001
A076699 002
A076699 003

Aug 27, 2004

Aug 27, 2004
Aug 27, 2004

4MG/5ML
4MG/5ML
4MG/5ML

A040814 001
A090418 001
A040458 001

Feb 26, 2008

May 04, 2010
Apr 25, 2003

4MG
4MG
4MG
4MG
4MG

A040639
A090417
A090435
A090756
A040442

002
001
001
001
001

May
Aug
Apr
May
Mar

30,
23,
15,
27,
19,

2008
2010
2010
2011
2003

50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
50MG/VIAL
150MG/VIAL
150MG/VIAL
450MG/VIAL
450MG/VIAL

A076235
A076235
A076235
A076099
A076099
A076099
A076602
A076602
A076602
A076959
A076959
A076959
A076162
A077383
A076162
A077383
A076162
A077383

001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003

Oct
Oct
Oct
Oct
Oct
Oct
Nov
Nov
Nov
Mar
Mar
Mar
Oct
Jan
Oct
Jan
Oct
Jan

14,
14,
14,
14,
14,
14,
16,
16,
16,
18,
18,
18,
14,
27,
14,
27,
14,
27,

2004
2004
2004
2004
2004
2004
2004
2004
2004
2005
2005
2005
2004
2006
2004
2006
2004
2006

A090475
A090475
A090475
A091268
A077266
A077266
A077247
A077266
A077266
A077244
A077244
A077244
A077244
A077998

001
002
003
002
001
002
003
003
004
001
002
003
004
001

Jul
Jul
Jul
Jul
Feb
Feb
Oct
Feb
Feb
Oct
Oct
Oct
Jan
Apr

29,
29,
29,
28,
15,
15,
21,
15,
15,
15,
15,
15,
20,
24,

2009
2009
2009
2010
2006
2006
2004
2006
2006
2004
2004
2004
2006
2007

CARBINOXAMINE MALEATE
SOLUTION; ORAL
CARBINOXAMINE MALEATE
BOCA PHARMA
AA
CYPRESS PHARM
AA
AA + MIKART

AA
AA
AA
AA
AA

TABLET; ORAL
CARBINOXAMINE MALEATE
BOCA PHARMA
CYPRESS PHARM
INVAGEN PHARMS
LYNROSE LABS
+ MIKART

CARBOPLATIN
INJECTABLE; INJECTION
CARBOPLATIN
APP PHARMS
AP
AP
AP
BEDFORD
AP
AP
AP
PLIVA
AP
AP
AP
SANDOZ
AP
AP
AP
AP + WATSON LABS
AP
AP +
AP
AP +
AP

INJECTABLE; IV (INFUSION)
CARBOPLATIN
AKORN
AP
50MG/5ML (10MG/ML)
AP
150MG/15ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
AP
600MG/60ML (10MG/ML)
APP PHARMS
AP
50MG/5ML (10MG/ML)
AP
150MG/15ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
AP
600MG/60ML (10MG/ML)
BEDFORD LABS
AP
50MG/5ML (10MG/ML)
AP
150MG/15ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
AP
600MG/60ML (10MG/ML)
BIONICHE PHARMA USA
AP
50MG/5ML (10MG/ML)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 78 (of 424)

CARBOPLATIN
INJECTABLE; IV (INFUSION)
CARBOPLATIN
BIONICHE PHARMA USA
AP
150MG/15ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
EBEWE PHARMA
AP
50MG/5ML (10MG/ML)
AP
150MG/15ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
FRESENIUS KABI ONCOL 450MG/45ML (10MG/ML)
AP
AP
50MG/5ML (10MG/ML)
AP
150MG/15ML (10MG/ML)
HOSPIRA
AP
50MG/5ML (10MG/ML)
AP
150MG/15ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
AP
600MG/60ML (10MG/ML)
ONCO THERAPIES LTD
AP
50MG/5ML (10MG/ML)
AP
150MG/15ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
AP
600MG/60ML (10MG/ML)
AP + PHARMACHEMIE
50MG/5ML (10MG/ML)
AP +
150MG/15ML (10MG/ML)
AP +
450MG/45ML (10MG/ML)
AP +
600MG/60ML (10MG/ML)
PHARMACHEMIE BV
AP
50MG/5ML (10MG/ML)
AP
150MG/15ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
PLIVA LACHEMA
AP
50MG/5ML (10MG/ML)
AP
150MG/15ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
AP
600MG/60ML (10MG/ML)
SUN PHARMA GLOBAL
AP
50MG/5ML (10MG/ML)
AP
150MG/15ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
AP + TEVA PARENTERAL
50MG/5ML (10MG/ML)
AP +
150MG/15ML (10MG/ML)
AP +
450MG/45ML (10MG/ML)
AP +
600MG/60ML (10MG/ML)
WATSON LABS
AP
50MG/5ML (10MG/ML)
AP
150MG/15ML (10MG/ML)
AP
450MG/45ML (10MG/ML)
AP
600MG/60ML (10MG/ML)
CARBOPLATIN
1GM/100ML (10MG/ML)
XX + ONCO THERAPIES LTD

A077998
A077998
A078280
A078280
A078280
A077432
A077432
A077432
A076517
A076517
A076517
A077059
A091063
A091063
A091063
A091063
A077269
A077269
A077269
A077269
A077679
A077679
A077679
A078631
A078631
A078631
A078631
A077926
A077926
A077926
A077139
A077139
A077139
A077139
A077861
A077861
A077861
A077861

002
003
001
002
003
003
001
002
001
002
003
001
001
002
003
004
001
002
003
004
001
002
003
001
002
003
004
001
002
003
001
002
003
004
001
002
003
004

A091478 001

Apr
Apr
May
May
May
Sep
Sep
Sep
Oct
Oct
Oct
Nov
Nov
Nov
Nov
Nov
Oct
Oct
Oct
Dec
Feb
Feb
Feb
Dec
Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Jan
Jan
Jan
Jan

24,
24,
08,
08,
08,
29,
29,
29,
14,
14,
14,
23,
09,
09,
09,
09,
14,
14,
14,
28,
25,
25,
25,
02,
02,
02,
02,
19,
19,
19,
21,
21,
21,
21,
18,
18,
18,
18,

2007
2007
2008
2008
2008
2006
2006
2006
2004
2004
2004
2004
2011
2011
2011
2011
2004
2004
2004
2007
2009
2009
2009
2008
2008
2008
2008
2008
2008
2008
2005
2005
2005
2005
2007
2007
2007
2007

Nov 23, 2011

CARBOPROST TROMETHAMINE
INJECTABLE; INJECTION

HEMABATE

XX + PHARMACIA AND UPJOHN

EQ 0.25MG BASE/ML

N017989 001

200MG

N022562 001

Mar 18, 2010

350MG
350MG
350MG

A040576 001
A040792 001
A040397 001

Jun 07, 2005

Aug 06, 2009
Sep 21, 2000

CARGLUMIC ACID
TABLET; ORAL

CARBAGLU

XX + ORPHAN EUROPE

CARISOPRODOL
TABLET; ORAL
CARISOPRODOL
ADVENT PHARMS
AA
AUROBINDO PHARMA
AA
COREPHARMA
AA

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 79 (of 424)

CARISOPRODOL

AA
AA
AA
AA
AA
AA
AA

TABLET; ORAL
CARISOPRODOL
MIRROR PHARMS
MUTUAL PHARM
PROSAM LABS
SUN PHARM INDS LTD
VINTAGE PHARMS
WATSON LABS
WEST WARD
SOMA
MEDA PHARMS
SOMA
+ MEDA PHARMS

22,
17,
07,
27,
08,
20,
24,

2008
1991
1997
2007
1997
1982
1996

A040823
A089346
A040188
A040755
A040245
A087499
A040124

350MG

N011792 001

250MG

N011792 004

Sep 13, 2007

IMPLANT; INTRACRANIAL

GLIADEL

XX + EISAI INC

7.7MG

N020637 001

Sep 23, 1996

INJECTABLE; INJECTION

BICNU

XX + BRISTOL

100MG/VIAL

N017422 001

AA
XX

001
001
001
001
001
001
001

Oct
Oct
Mar
Feb
Sep
Apr
Jan

350MG
350MG
350MG
350MG
350MG
350MG
350MG

CARMUSTINE

CARTEOLOL HYDROCHLORIDE

AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
CARTEOLOL HYDROCHLORIDE
ALCON
1%
BAUSCH AND LOMB
1%
NOVEX
1%
OCUPRESS
+ NOVARTIS
1%

A075476 001
A075546 001
A076097 001

Jan 03, 2000

Jan 20, 2000
Feb 06, 2002

N019972 001

May 23, 1990

A078165
A078165
A078165
A078165
A078332
A078332
A078332
A078332
A078384
A078384
A078384
A078384
A077346
A077346
A077346
A077346
A076649
A076649
A076649
A076649
A078251
A078251
A078251
A078251
A077887

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

CARVEDILOL
TABLET; ORAL
CARVEDILOL
APOTEX INC
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
BEXIMCO USA
AB
AB
AB
AB
CARACO
AB
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
AB
HIKMA
AB

3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG

001
002
003
004
001
002
003
004
001
002
003
004
004
001
002
003
001
002
003
004
001
002
003
004
001

05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
07,

2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 80 (of 424)

CARVEDILOL
TABLET; ORAL
CARVEDILOL
HIKMA
AB
AB
AB
LUPIN
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
PLIVA HRVATSKA DOO
AB
AB
AB
AB
RANBAXY
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
TARO
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
WOCKHARDT
AB
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB
AB
AB
COREG
SMITHKLINE BEECHAM
AB
AB
AB +
AB

6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG
3.125MG
6.25MG
12.5MG
25MG

A077887
A077887
A077887
A078217
A078217
A078217
A078217
A077316
A077316
A077316
A077316
A078240
A078240
A078240
A078240
A076989
A076989
A076989
A076989
A078227
A078227
A078227
A078227
A077780
A077780
A077780
A077780
A076373
A076373
A076373
A076373
A077474
A077474
A077474
A077474
A078786
A078786
A078786
A078786
A077614
A077614
A077614
A077614

002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
004
001
002
003

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Dec
Dec
Dec
Dec
Sep
Sep
Sep
Sep

07,
07,
07,
05,
05,
05,
05,
05,
05,
05,
05,
30,
30,
30,
30,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
05,
22,
22,
22,
22,
05,
05,
05,
05,

2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2009
2009
2009
2009
2007
2007
2007
2007

3.125MG
6.25MG
12.5MG
25MG

N020297
N020297
N020297
N020297

004
003
002
001

May
Sep
Sep
Sep

29,
14,
14,
14,

1997
1995
1995
1995

N022012
N022012
N022012
N022012

001
002
003
004

Oct
Oct
Oct
Oct

20,
20,
20,
20,

2006
2006
2006
2006

CARVEDILOL PHOSPHATE
CAPSULE, EXTENDED RELEASE; ORAL
COREG CR
SB PHARMCO
10MG
XX
20MG
XX
40MG
XX +
80MG
XX

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 81 (of 424)

CASPOFUNGIN ACETATE
INJECTABLE; IV (INFUSION)

CANCIDAS

XX + MERCK
50MG/VIAL
XX +
70MG/VIAL

N021227 001
N021227 002

Jan 26, 2001

Jan 26, 2001

CEFACLOR
CAPSULE; ORAL
CEFACLOR
HIKMA
AB
AB +
RANBAXY
AB
AB
YUNG SHIN PHARM
AB
AB

XX
XX
XX
XX

FOR SUSPENSION; ORAL

CEFACLOR

+ RANBAXY
+
+
+

TABLET, CHEWABLE; ORAL

RANICLOR
RANBAXY
XX
XX
XX
XX +

EQ
EQ
EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE

A065350
A065350
A064156
A064156
A065146
A065146

001
002
001
002
001
002

Apr
Apr
Aug
Aug
Jan
Jan

03,
03,
28,
28,
22,
22,

2007
2007
1997
1997
2004
2004

EQ
EQ
EQ
EQ

125MG
187MG
250MG
375MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A064166
A064165
A064164
A064155

001
001
001
001

Oct
Oct
Oct
Oct

02,
02,
02,
02,

1997
1997
1997
1997

EQ
EQ
EQ
EQ

125MG
187MG
250MG
375MG

BASE
BASE
BASE
BASE

A065092
A065092
A065092
A065092

001
002
003
004

Dec
Dec
Dec
Dec

22,
22,
22,
22,

2003
2003
2003
2003

TABLET, EXTENDED RELEASE; ORAL

CEFACLOR
TEVA
EQ 375MG BASE
XX
EQ 500MG BASE
XX +

A065058 001
A065058 002

Sep 04, 2002

Sep 04, 2002

CEFADROXIL/CEFADROXIL HEMIHYDRATE

AB
AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
CEFADROXIL
AUROBINDO PHARMA
HIKMA
LUPIN
ORCHID HLTHCARE
RANBAXY
SANDOZ
+ TEVA PHARMS

EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG
500MG
500MG
500MG
500MG
500MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE

A065352
A065311
A065392
A065309
A065015
A062291
A065282

001
001
001
001
001
001
001

Jan
Feb
May
Sep
Jun

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A065396
A065396
A065307
A065307
A065115
A065115
A065278
A065278

001
002
002
003
002
003
001
002

Feb
Feb
Oct
Oct
Mar
Mar
Jan
Jan

25,
07,
29,
18,
22,

2007
2006
2007
2006
1999

Jan 20, 2006

FOR SUSPENSION; ORAL

CEFADROXIL
LUPIN
AB
AB +
ORCHID HLTHCARE
AB
AB
RANBAXY
AB
AB
TEVA PHARMS
AB
AB
CEFADROXIL
RANBAXY
XX

EQ 125MG BASE/5ML

A065115 001

Mar 26, 2003

TABLET; ORAL
CEFADROXIL
HIKMA
AB
ORCHID HLTHCARE
AB
RANBAXY
AB

EQ 1GM BASE
EQ 1GM BASE
EQ 1GM BASE

A065260 001
A065301 001
A065018 001

Mar 30, 2006

Sep 18, 2006
Apr 23, 1999

21,
21,
16,
16,
26,
26,
20,
20,

2008
2008
2006
2006
2003
2003
2006
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 82 (of 424)

CEFADROXIL/CEFADROXIL HEMIHYDRATE
TABLET; ORAL

CEFADROXIL

XX + IVAX SUB TEVA PHARMS

EQ 1GM BASE

A062774 001

Apr 08, 1987

500MG BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
20GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
20GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
500MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
20GM BASE/VIAL

A065303
A065303
A065306
A064169
A064169
A064170
A064170
A065395
A065395
A065280
A065280
A065295
A065296
A065047
A065047
A065143
A065226
A065226
A065244
A065247
A062831
A062831
A065345
A062831
A063214
A063216
A063207
A063208
A063209
A063209

Oct
Oct
Oct
Aug
Aug
Mar
Mar
Aug
Aug
Mar
Mar
Mar
Mar
Sep
Sep
Oct
Apr
Apr
Aug
Aug
Dec
Dec
May
Sep
Dec
Dec
Dec
Dec
Dec
Apr

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

A061773 002
A061773 003
A061773 004

10MG BASE/ML
20MG BASE/ML

A063002 001
A063002 002

Mar 28, 1991

Mar 28, 1991

1GM BASE/VIAL

N050779 002

Jul 27, 2000

100GM BASE/VIAL
300GM BASE/VIAL

A065141 001
A065141 002

Nov 29, 2006

Nov 29, 2006

A065434
A065264
A065418
A065330
A065368

Jan
May
Jul
Apr
May

CEFAZOLIN SODIUM
INJECTABLE; INJECTION
CEFAZOLIN SODIUM
ACS DOBFAR
AP
EQ
AP
EQ
AP
EQ
AP + APP PHARMS
EQ
AP +
EQ
AP +
EQ
AP +
EQ
AUROBINDO PHARMA
AP
EQ
AP
EQ
CEPHAZONE PHARMA
AP
EQ
AP
EQ
AP
EQ
AP
EQ
HIKMA FARMACEUTICA
AP
EQ
AP
EQ
AP
EQ
HOSPIRA INC
AP
EQ
AP
EQ
AP
EQ
AP
EQ
SANDOZ
AP
EQ
AP
EQ
AP
EQ
AP
EQ
STERI PHARMA
AP
EQ
AP
EQ
AP
EQ
AP
EQ
AP
EQ
AP
EQ
KEFZOL
ACS DOBFAR
AP
EQ
AP
EQ
AP
EQ
ANCEF IN PLASTIC CONTAINER
EQ
XX + BAXTER HLTHCARE
EQ
XX +
CEFAZOLIN AND DEXTROSE
EQ
XX + B BRAUN
CEFAZOLIN SODIUM
EQ
XX + SAMSON MEDCL
EQ
XX +

001
002
001
001
002
001
002
001
002
001
002
001
001
001
002
001
001
002
001
001
001
002
001
003
001
001
001
001
001
002

22,
22,
22,
14,
14,
18,
18,
08,
08,
18,
18,
18,
18,
18,
18,
18,
21,
21,
12,
12,
09,
09,
09,
25,
27,
27,
27,
27,
27,
30,

2008
2008
2008
1998
1998
1998
1998
2008
2008
2009
2009
2009
2009
2001
2001
2004
2005
2005
2005
2005
1988
1988
2007
1992
1991
1991
1991
1991
1991
1999

CEFDINIR

AB
AB
AB
AB
AB

CAPSULE; ORAL
CEFDINIR
AUROBINDO PHARMA
LUPIN
ORCHID HLTHCARE
+ SANDOZ
TEVA PHARMS

300MG
300MG
300MG
300MG
300MG

001
001
001
001
001

07,
19,
18,
06,
09,

2008
2006
2007
2007
2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 83 (of 424)

CEFDINIR
FOR SUSPENSION; ORAL
CEFDINIR
AUROBINDO PHARMA
AB
AB
LUPIN
AB
AB
ORCHID HLTHCARE
AB
AB
SANDOZ
AB
AB +
TEVA PHARMS
AB
AB

001
002
001
002
001
002
001
002
001
002

Dec
Dec
May
May
Jul
Jul
Apr
Apr
May
May

14,
14,
31,
07,
18,
18,
06,
06,
04,
04,

2007
2007
2006
2007
2007
2007
2007
2007
2007
2007

125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML

A065473
A065473
A065259
A065259
A065429
A065429
A065337
A065337
A065332
A065332

200MG
400MG

N021222 001
N021222 002

Aug 29, 2001

Jul 21, 2008

A065441
A065441
A065369
A065369
A065369
A090291
A090291
A090291

Mar
Mar
Jun
Jun
Jun
Dec
Dec
Dec

CEFDITOREN PIVOXIL
TABLET; ORAL
SPECTRACEF
CORNERSTONE THERAP
XX
XX +

CEFEPIME HYDROCHLORIDE
INJECTABLE; INJECTION
CEFEPIME HYDROCHLORIDE
ACS DOBFAR
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
HOSPIRA INC
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
SANDOZ
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
MAXIPIME
AP + HOSPIRA INC
EQ 500MG BASE/VIAL
AP +
EQ 1GM BASE/VIAL
AP +
EQ 2GM BASE/VIAL
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
B BRAUN
EQ 1GM BASE/VIAL
XX
EQ 2GM BASE/VIAL
XX
CEFEPIME IN PLASTIC CONTAINER
EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
XX + BAXTER HLTHCARE
EQ 2GM BASE/100ML (EQ 20MG BASE/ML)
XX +

001
002
001
002
003
001
002
003

20,
20,
18,
18,
18,
21,
21,
21,

2008
2008
2007
2007
2007
2010
2010
2010

N050679 001
N050679 002
N050679 003

Jan 18, 1996

Jan 18, 1996
Jan 18, 1996

N050821 001
N050821 002

May 06, 2010

May 06, 2010

N050817 001
N050817 002

Aug 05, 2008

Aug 05, 2008

CEFIXIME
SUSPENSION; ORAL
SUPRAX
LUPIN PHARMS
XX
XX +

100MG/5ML
200MG/5ML

A065129 001
A065355 001

Feb 23, 2004

Apr 10, 2007

TABLET; ORAL

SUPRAX

XX + LUPIN PHARMS

400MG

A065130 001

Feb 12, 2004

TABLET, CHEWABLE; ORAL

SUPRAX
LUPIN LTD
XX
XX
XX +

100MG
150MG
200MG

A065380 001
A065380 002
A065380 003

Oct 25, 2010

Oct 25, 2010
Oct 25, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 84 (of 424)

CEFOTAXIME SODIUM
INJECTABLE; INJECTION
CEFOTAXIME
APP PHARMS
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
HIKMA
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
WOCKHARDT
AP
EQ 1GM BASE/VIAL
CEFOTAXIME SODIUM
AUROBINDO PHARMA
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
CEPHAZONE PHARMA
AP
EQ 10GM BASE/VIAL
HOSPIRA INC
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
LUPIN
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
WOCKHARDT
AP
EQ 500MG BASE/VIAL
AP
EQ 2GM BASE/VIAL
CLAFORAN
AP + SANOFI AVENTIS US
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP +
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP +
EQ 2GM BASE/VIAL
AP +
EQ 10GM BASE/VIAL
CEFOTAXIME
EQ 20GM BASE/VIAL
XX + APP PHARMS
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
EQ 20MG BASE/ML
XX + SANOFI AVENTIS US
EQ 40MG BASE/ML
XX +

A064200
A064200
A064200
A064201
A065072
A065072
A065072
A065071
A065197

001
002
003
001
001
002
003
001
001

Mar
Mar
Mar
Mar
Nov
Nov
Nov
Nov
Aug

24,
24,
24,
24,
20,
20,
20,
20,
29,

2000
2000
2000
2000
2002
2002
2002
2002
2006

A065517
A065517
A065517
A065516
A065348
A065290
A065290
A065293
A065290
A065293
A065292
A065124
A065124
A065124
A065197
A065197

001
002
003
001
001
001
002
001
003
002
001
001
002
003
002
003

Nov
Nov
Nov
Nov
Jan
Aug
Aug
Aug
Aug
Aug
Aug
Sep
Sep
Sep
Jun
Jun

06,
06,
06,
06,
25,
11,
11,
10,
11,
10,
10,
24,
24,
24,
20,
20,

2009
2009
2009
2009
2010
2006
2006
2006
2006
2006
2006
2003
2003
2003
2008
2008

N050547
A062659
N050547
A062659
N050547
N050547

001
001
002
002
003
004

Dec 29, 1983

A064201 002

Mar 24, 2000

N050596 002
N050596 004

May 20, 1985

May 20, 1985

A065374
A065374
A065375
A091031
A091031
A091030

Aug
Aug
Aug
Oct
Oct
Oct

Jan 13, 1987

Jan 13, 1987

CEFOTETAN DISODIUM

AP
AP
AP
AP
AP
AP
XX
XX

INJECTABLE; INJECTION
CEFOTETAN
+ APP PHARMS
+
+
WEST-WARD PHARM CORP

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
+ B BRAUN
EQ 1GM BASE/VIAL
+
EQ 2GM BASE/VIAL

001
002
001
001
002
001

09,
09,
09,
26,
26,
26,

2007
2007
2007
2011
2011
2011

A065430 001
A065430 002

Aug 09, 2007

Aug 09, 2007

A065467 001
A065467 002

Aug 31, 2011

Aug 31, 2011

CEFOXITIN
INJECTABLE; INJECTION
CEFOXITIN
ANTIBIOTICOS BRASIL
AP
AP

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 85 (of 424)

CEFOXITIN
INJECTABLE; INJECTION
CEFOXITIN
ANTIBIOTICOS BRASIL
AP

EQ 10GM BASE/VIAL

A065464 001

Aug 31, 2011

A065414
A065414
A065415
A065012
A065012
A065011
A065051
A065051
A065050
A065238
A065238
A065239
A065313
A065313
A065312

Jun
Jun
May
Jul
Jul
Jul
Sep
Sep
Sep
Mar
Mar
Mar
Jan
Jan
Feb

CEFOXITIN SODIUM
INJECTABLE; INJECTION
CEFOXITIN
ACS DOBFAR
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
AP + APP PHARMS
EQ 1GM BASE/VIAL
AP +
EQ 2GM BASE/VIAL
AP +
EQ 10GM BASE/VIAL
BAXTER HLTHCARE
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
HIKMA FARMACEUTICA
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
HOSPIRA INC
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
B BRAUN
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
MEFOXIN IN PLASTIC CONTAINER
EQ 20MG BASE/ML
XX + BIONICHE PHARMA
EQ 40MG BASE/ML
XX +

001
002
001
001
002
001
001
002
001
001
002
001
001
002
001

12,
12,
19,
03,
03,
03,
11,
11,
11,
12,
12,
02,
23,
23,
13,

2009
2009
2010
2000
2000
2000
2000
2000
2000
2010
2010
2010
2006
2006
2006

A065214 001
A065214 002

Mar 10, 2006

Mar 10, 2006

A063182 001
A063182 002

Jan 25, 1993

Jan 25, 1993

CEFPODOXIME PROXETIL
FOR SUSPENSION; ORAL
CEFPODOXIME PROXETIL
AUROBINDO PHARMA
AB
AB +
RANBAXY
AB
AB
SANDOZ
AB
AB

EQ
EQ
EQ
EQ
EQ
EQ

50MG BASE/5ML
100MG BASE/5ML
50MG BASE/5ML
100MG BASE/5ML
50MG BASE/5ML
100MG BASE/5ML

A065409
A065409
A065082
A065082
A090031
A090031

001
002
001
002
001
002

Jun
Jun
May
May
Jan
Jan

08,
08,
31,
31,
14,
14,

2007
2007
2002
2002
2009
2009

TABLET; ORAL
CEFPODOXIME PROXETIL
AUROBINDO PHARMA
AB
AB
ORCHID HLTHCARE
AB
AB
RANBAXY
AB
AB
SANDOZ
AB
AB +

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG

A065370
A065370
A065388
A065388
A065083
A065083
A065462
A065462

001
002
001
002
001
002
001
002

Jun
Jun
Nov
Nov
Aug
Aug
May
May

11,
11,
14,
14,
20,
20,
28,
28,

2007
2007
2007
2007
2003
2003
2008
2008

A065381
A065381
A065261
A065261
A065284
A065284
A065202

001
002
001
002
002
001
001

Jan
Jan
Dec
Dec
Dec
Dec
Jun

30,
30,
19,
19,
30,
30,
30,

2007
2007
2005
2005
2005
2005
2006

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

CEFPROZIL
FOR SUSPENSION; ORAL
CEFPROZIL
AUROBINDO PHARMA
AB
AB
LUPIN
AB
AB +
ORCHID HLTHCARE
AB
AB
RANBAXY
AB

125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 86 (of 424)

CEFPROZIL
FOR SUSPENSION; ORAL
CEFPROZIL
RANBAXY
AB
SANDOZ
AB
AB
TEVA PHARMS
AB
AB

250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML

A065202
A065257
A065257
A065236
A065236

002
001
002
001
002

Jun
Dec
Dec
Dec
Dec

30,
08,
08,
08,
08,

2006
2005
2005
2005
2005

TABLET; ORAL
CEFPROZIL
APOTEX INC
AB
AB
AUROBINDO PHARMA LTD
AB
AB
LUPIN
AB
AB +
ORCHID HLTHCARE
AB
AB
RANBAXY
AB
AB
SANDOZ
AB
AB
TEVA
AB
AB
WOCKHARDT
AB
AB

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

A065327
A065327
A065340
A065340
A065276
A065276
A065267
A065267
A065198
A065198
A065235
A065235
A065208
A065208
A065428
A065428

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Mar
Mar
May
May
Dec
Dec
Dec
Dec
Dec
Dec
Nov
Nov
Dec
Dec
Jun
Jun

26,
26,
24,
24,
08,
08,
19,
19,
13,
13,
14,
14,
06,
06,
14,
14,

2008
2008
2007
2007
2005
2005
2005
2005
2006
2006
2005
2005
2005
2005
2007
2007

400MG/VIAL
600MG/VIAL

N200327 001
N200327 002

Oct 29, 2010

Oct 29, 2010

500MG/VIAL
1GM/VIAL
2GM/VIAL
6GM/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL
6GM/VIAL
1GM/VIAL

A062640
A062640
A062640
A062640
A065481
A065481
A065481
A065482
A065196

001
002
003
004
001
002
003
001
001

Nov
Nov
Nov
Feb
May
May
May
May
Oct

20,
20,
20,
03,
28,
28,
28,
28,
15,

1985
1985
1985
1992
2010
2010
2010
2010
2008

500MG/VIAL
1GM/VIAL
2GM/VIAL
6GM/VIAL

N050578
N050578
N050578
N050578

001
002
003
004

Jul
Jul
Jul
Jul

19,
19,
19,
19,

1985
1985
1985
1985

500MG/VIAL
1GM/VIAL
1GM/VIAL
2GM/VIAL
2GM/VIAL
6GM/VIAL
CONTAINER
EQ 1GM BASE
EQ 2GM BASE

A062662
A062662
A064032
A062662
A064032
A062662

001
002
001
003
002
004

Mar
Mar
Oct
Mar
Oct
Mar

06,
06,
31,
06,
31,
06,

1986
1986
1993
1986
1993
1986

CEFTAROLINE FOSAMIL
POWDER; IV (INFUSION)
TEFLARO
CEREXA
XX
XX +

CEFTAZIDIME
INJECTABLE; INJECTION
CEFTAZIDIME
ACS DOBFAR
AP
AP
AP
AP
AUROBINDO PHARMA
AP
AP
AP
AP
WOCKHARDT
AP
FORTAZ
AP + GLAXOSMITHKLINE
AP +
AP +
AP +
TAZICEF
HOSPIRA
AP
AP
AP
AP
AP
AP
CEFTAZIDIME IN DEXTROSE
B BRAUN
XX
XX +

N050823 001
N050823 002

Jun 13, 2011

Jun 13, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 87 (of 424)

CEFTAZIDIME SODIUM
INJECTABLE; INJECTION

FORTAZ IN PLASTIC CONTAINER

EQ 20MG BASE/ML
XX + GLAXOSMITHKLINE
EQ 40MG BASE/ML
XX +

N050634 002
N050634 003

Apr 28, 1989

Apr 28, 1989

CEFTIBUTEN DIHYDRATE
CAPSULE; ORAL

CEDAX

XX + PERNIX THERAP

EQ 400MG BASE

N050685 002

Dec 20, 1995

FOR SUSPENSION; ORAL

CEDAX

XX + PERNIX THERAP

EQ 90MG BASE/5ML

N050686 001

Dec 20, 1995

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A065245
A065245
A065245
A065245
A065505
A065505
A065505
A065505
A065465
A065465
A065465
A065465
A065294
A065294
A065294
A065294
A065342
A065342
A065342
A065342
A065230
A065230
A065230
A065230
A065305
A065305
A065305
A065305
A065125
A065125
A065125
A065125
A065169
A065169
A065169
A065169
A065268
A065268
A065262
A065262
A065227
A065227
A065227

Feb
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Aug
Aug
Aug
Aug
Mar
Mar
Mar
Mar
Jan
Jan
Jan
Jan
Aug
Aug
Aug
Aug
Jan
Jan
Jan
Jan
Sep
Sep
Sep
Sep
May
May
May
May
Feb
Feb
Jun
Jun
Mar
Mar
Mar

CEFTRIAXONE SODIUM
INJECTABLE; IM-IV
CEFTRIAXONE
APP PHARMS
AP
AP
AP
AP
AUROBINDO PHARMA
AP
AP
AP
AP
BEDFORD
AP
AP
AP
AP
CEPHAZONE PHARMA
AP
AP
AP
AP
HIKMA FARMACEUTICA
AP
AP
AP
AP
HOSPIRA INC
AP
AP
AP
AP
LUITPOLD
AP
AP
AP
AP
LUPIN
AP
AP
AP
AP
AP + SANDOZ
AP +
AP +
AP +
STERI PHARMA
AP
AP
TEVA
AP
AP
TEVA PARENTERAL
AP
AP
AP

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

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
001
002
001
002
003

15,
15,
15,
15,
31,
31,
31,
31,
18,
18,
18,
18,
26,
26,
26,
26,
10,
10,
10,
10,
02,
02,
02,
02,
11,
11,
11,
11,
30,
30,
30,
30,
09,
09,
09,
09,
28,
28,
29,
29,
15,
15,
15,

2006
2006
2006
2006
2008
2008
2008
2008
2008
2008
2008
2008
2007
2007
2007
2007
2008
2008
2008
2008
2005
2005
2005
2005
2008
2008
2008
2008
2003
2003
2003
2003
2005
2005
2005
2005
2007
2007
2006
2006
2007
2007
2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 88 (of 424)

CEFTRIAXONE SODIUM
INJECTABLE; IM-IV
CEFTRIAXONE
TEVA PARENTERAL
AP
WOCKHARDT
AP
AP
AP

EQ
EQ
EQ
EQ

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

INJECTABLE; INJECTION
CEFTRIAXONE
ACS DOBFAR
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
APP PHARMS
AP
EQ 10GM BASE/VIAL
AUROBINDO PHARMA
AP
EQ 10GM BASE/VIAL
BEDFORD
AP
EQ 10GM BASE/VIAL
HOSPIRA INC
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP
EQ 10GM BASE/VIAL
LUPIN
AP
EQ 10GM BASE/VIAL
SANDOZ
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
AP +
EQ 10GM BASE/VIAL
STERI PHARMA
AP
EQ 10GM BASE/VIAL
TEVA
AP
EQ 10GM BASE/VIAL
WOCKHARDT
AP
EQ 1GM BASE/VIAL
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
AP + B BRAUN
EQ 1GM BASE/VIAL
AP +
EQ 2GM BASE/VIAL
ROCEPHIN
AP + HOFFMANN LA ROCHE
EQ 500MG BASE/VIAL
AP +
EQ 1GM BASE/VIAL
CEFTRIAXONE IN PLASTIC CONTAINER
BAXTER HLTHCARE
EQ 20MG BASE/ML
XX
EQ 40MG BASE/ML
XX

A065227
A065391
A065391
A065391

004
001
002
003

Mar
Apr
Apr
Apr

15,
12,
12,
12,

2007
2007
2007
2007

A065329
A065329
A065329
A065328
A065252
A065504
A065475
A065231
A065231
A065232
A065263
A065204
A065204
A065168
A065269
A065274
A065180

001
002
003
001
001
001
001
001
002
001
001
001
002
001
001
001
001

Jul
Jul
Jul
Jul
Feb
Jul
Aug
Aug
Aug
Aug
Sep
May
May
May
Feb
May
May

24,
24,
24,
24,
15,
31,
18,
02,
02,
02,
12,
03,
03,
17,
28,
01,
12,

2008
2008
2008
2008
2006
2008
2008
2005
2005
2005
2006
2005
2005
2005
2007
2006
2006

N050796 001
N050796 002

Apr 20, 2005

Apr 20, 2005

A063239 002
A063239 003

Aug 13, 1993

Aug 13, 1993

A065224 001
A065224 002

Aug 23, 2005

Aug 23, 2005

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

N050672 001
N050672 002

Jun 30, 1994

Apr 29, 1997

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

A065323 001
A065323 002

Feb 05, 2008

Feb 05, 2008

EQ 125MG BASE
EQ 250MG BASE
EQ 500MG BASE

N050605 001
N050605 002
N050605 003

Dec 28, 1987

Dec 28, 1987
Dec 28, 1987

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A065496
A065496
A065069
A065069
A065308
A065308
A065308
A065135
A065135
A065359

Jun
Jun
Oct
Oct
Mar
Mar
Mar
Jul
Jul
Feb

CEFUROXIME AXETIL
FOR SUSPENSION; ORAL
CEFTIN
GLAXOSMITHKLINE
AB
AB +
CEFUROXIME AXETIL
RANBAXY
AB
AB
TABLET; ORAL
CEFTIN
GLAXOSMITHKLINE
AB
AB
AB +
CEFUROXIME AXETIL
ALKEM LABS LTD
AB
AB
APOTEX
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
LUPIN
AB
AB
ORCHID HLTHCARE
AB

250MG
500MG
250MG
500MG
125MG
250MG
500MG
250MG
500MG
125MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
002
001
002
001
002
003
001
002
001

07,
07,
02,
02,
29,
29,
29,
25,
25,
15,

2010
2010
2002
2002
2006
2006
2006
2003
2003
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 89 (of 424)

CEFUROXIME AXETIL
TABLET; ORAL
CEFUROXIME AXETIL
ORCHID HLTHCARE
AB
AB
RANBAXY
AB
AB
AB
AB
AB
AB
TEVA
AB
AB
WOCKHARDT
AB
AB
AB

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

250MG
500MG
125MG
125MG
250MG
250MG
500MG
500MG
250MG
500MG
125MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A065359
A065359
A065043
A065118
A065043
A065118
A065043
A065118
A065190
A065190
A065166
A065166
A065166

002
003
003
001
002
002
001
003
001
002
001
002
003

Feb
Feb
Feb
Apr
Feb
Apr
Feb
Apr
Oct
Oct
Jul
Jul
Jul

15,
15,
15,
25,
15,
25,
15,
25,
18,
18,
29,
29,
29,

2008
2008
2002
2003
2002
2003
2002
2003
2004
2004
2005
2005
2005

EQ
EQ
EQ
EQ

750MG
750MG
750MG
750MG

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

A065001
A065048
A064125
A064192

001
001
001
002

May
Jan
May
Apr

30,
09,
30,
16,

2001
2004
1997
1998

CEFUROXIME SODIUM

AB
AB
AB
AB
AB
AP

INJECTABLE; IM-IV
CEFUROXIME SODIUM
APP PHARMS
HIKMA FARMACEUTICA
STERI PHARMA
TEVA
ZINACEF
+ GLAXOSMITHKLINE
CEFUROXIME SODIUM
HOSPIRA INC

EQ 750MG BASE/VIAL

N050558 002

Oct 19, 1983

EQ 750MG BASE/VIAL

A065483 001

Oct 15, 2008

N050780 001
N050780 002

Feb 21, 2001

Feb 21, 2001

A065001
A065002
A065048
A065046
A065483
A065503
A065484
A064125
A064124
A064192
A064191

May
Sep
Jan
Jan
Oct
Oct
Oct
May
May
Apr
Apr

INJECTABLE; INJECTION
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
AP + B BRAUN
EQ 750MG BASE/VIAL
AP +
EQ 1.5GM BASE/VIAL
CEFUROXIME SODIUM
APP PHARMS
AP
EQ 1.5GM BASE/VIAL
AP
EQ 7.5GM BASE/VIAL
HIKMA FARMACEUTICA
AP
EQ 1.5GM BASE/VIAL
AP
EQ 7.5GM BASE/VIAL
HOSPIRA INC
AP
EQ 1.5GM BASE/VIAL
AP
EQ 1.5GM BASE/VIAL
AP
EQ 7.5GM BASE/VIAL
STERI PHARMA
AP
EQ 1.5GM BASE/VIAL
AP
EQ 7.5GM BASE/VIAL
TEVA
AP
EQ 1.5GM BASE/VIAL
AP
EQ 7.5GM BASE/VIAL
ZINACEF
AP + GLAXOSMITHKLINE
EQ 1.5GM BASE/VIAL
AP +
EQ 7.5GM BASE/VIAL
CEFUROXIME SODIUM IN PLASTIC CONTAINER
EQ 75GM BASE/VIAL
XX + SAMSON MEDCL
EQ 225GM BASE/VIAL
XX +
ZINACEF IN PLASTIC CONTAINER
EQ 15MG BASE/ML
XX + GLAXOSMITHKLINE
EQ 30MG BASE/ML
XX +

002
001
002
001
002
001
001
002
001
001
001

30,
28,
09,
09,
15,
15,
15,
30,
30,
16,
16,

2001
1998
2004
2004
2008
2008
2008
1997
1997
1998
1998

N050558 003
N050558 004

Oct 19, 1983

Oct 23, 1986

A065251 001
A065251 002

Dec 30, 2009

Dec 30, 2009

N050643 001
N050643 002

Apr 28, 1989

Apr 28, 1989

N020998 004
N020998 001
N020998 002

Dec 15, 2006

Dec 31, 1998
Dec 31, 1998

CELECOXIB
CAPSULE; ORAL
CELEBREX
GD SEARLE
XX
XX
XX

50MG
100MG
200MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 90 (of 424)

CELECOXIB
CAPSULE; ORAL

CELEBREX

XX + GD SEARLE

400MG

N020998 003

Aug 29, 2002

A090836
A090836
A065253
A065253
A062713
A062713
A062118
A062118
A065215
A065215
A065229
A065229
A065248
A065248
A065007
A065007
A062870
A062791
A062791
A062702
A062702
A065152
A065152

Dec
Dec
Nov
Nov
Jul
Jul

20,
20,
16,
16,
15,
15,

2010
2010
2005
2005
1988
1988

Jan
Jan
Nov
Nov
Jun
Jun
Sep
Sep
Mar
Jun
Jun
Feb
Feb
Feb
Feb

24,
24,
25,
25,
28,
28,
16,
16,
17,
11,
11,
13,
13,
24,
24,

2006
2006
2005
2005
2005
2005
1999
1999
1988
1987
1987
1987
1987
2005
2005

CEPHALEXIN
CAPSULE; ORAL
CEPHALEXIN
ALKEM
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
AB
KEFLEX
SHIONOGI INC
AB
AB
KEFLEX
XX + SHIONOGI INC

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
001
002
001
002
001
002

EQ 250MG BASE
EQ 500MG BASE

N050405 002
N050405 003

EQ 750MG BASE

N050405 005

May 12, 2006

FOR SUSPENSION; ORAL

CEPHALEXIN
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
AB

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A062117
A062117
A065444
A065444
A065234
A065234
A065326
A065326
A065081
A065081
A062703
A062703
A065336
A065336

Aug
Aug
Aug
Aug
Jul
Jul
Jul
Jul
Feb
Feb
Jul
Jul

TABLET; ORAL

CEPHALEXIN

TEVA

XX
XX +

EQ 250MG BASE
EQ 500MG BASE

125MG
250MG
125MG
250MG
125MG
250MG
125MG
250MG
125MG
250MG
125MG
250MG
125MG
250MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

002
003
001
002
001
002
001
002
001
002
001
002
001
002

A063023 001
A063024 001

28,
28,
17,
17,
10,
10,
27,
27,
13,
13,
25,
25,

2009
2009
2005
2005
2006
2006
2001
2001
1987
1987
2007
2007

Jan 12, 1989

Jan 12, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 91 (of 424)

CETIRIZINE HYDROCHLORIDE

AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA

SYRUP; ORAL
CETIRIZINE HYDROCHLORIDE
AMNEAL PHARMS
5MG/5ML
APOTEX INC
5MG/5ML
AUROBINDO PHARMA
5MG/5ML
CYPRESS PHARM
5MG/5ML
DR REDDYS LABS LTD
5MG/5ML
PERRIGO R AND D
5MG/5ML
RANBAXY
5MG/5ML
SUN PHARM INDS INC
5MG/5ML
TARO
5MG/5ML
TEVA PHARMS
5MG/5ML
VINTAGE
5MG/5ML
WOCKHARDT
5MG/5ML
ZYRTEC
+ MCNEIL CONSUMER
5MG/5ML

A090766
A078412
A090751
A078488
A078870
A078398
A077472
A090191
A076601
A077279
A078496
A078757

001
001
001
001
001
001
001
001
001
001
001
001

Oct
Jun
Dec
Oct
Apr
Jun
Jun
Nov
Jun
May
Sep
Aug

07,
18,
16,
06,
27,
17,
18,
12,
20,
27,
25,
28,

2009
2008
2009
2008
2009
2008
2008
2009
2008
2008
2009
2009

N020346 001

Sep 27, 1996

EQ 0.25MG BASE/ML
EQ 3MG BASE/ML

N021197 001
N021197 002

Aug 11, 2000

Aug 11, 2000

30MG

A091260 001

Aug 25, 2011

30MG

N020989 002

Jan 11, 2000

250MG

A091019 001

Oct 22, 2009

2MG

N010669 002

CETRORELIX
INJECTABLE; INJECTION

CETROTIDE

XX + EMD SERONO
XX +

CEVIMELINE HYDROCHLORIDE
CAPSULE; ORAL
CEVIMELINE
APOTEX INC
AB
EVOXAC
AB + DAIICHI SANKYO CO

CHENODIOL
TABLET; ORAL

CHENODIOL

XX + NEXGEN PHARMA

CHLORAMBUCIL
TABLET; ORAL

LEUKERAN

XX + PBS

CHLORAMPHENICOL SODIUM SUCCINATE

INJECTABLE; INJECTION

CHLORAMPHENICOL SODIUM SUCCINATE

EQ 1GM BASE/VIAL
XX + APP PHARMS

A062365 001

CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE; ORAL
CHLORDIAZEPOXIDE HYDROCHLORIDE
BARR
AB
5MG
AB
10MG
AB
25MG
USL PHARMA
AB
10MG
WATSON LABS
AB
5MG
AB
10MG
AB
25MG
LIBRIUM
VALEANT PHARM INTL
AB
5MG
AB
10MG

A084768
A083116
A084769
A084623
A086383
A086294
A086382

001
001
001
001
001
001
001

A085461 001
A085472 001

Aug 25, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 92 (of 424)

CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE; ORAL
LIBRIUM
AB + VALEANT PHARM INTL

25MG

A085475 001

0.12%
0.12%
0.12%
0.12%
0.12%
0.12%
0.12%

A074356
A076434
A074291
A075561
A074522
A075006
A077789

0.12%

N019028 001

Aug 13, 1986

0.12%

A073695 001

Jan 14, 1994

2.5MG

N020774 001

May 15, 1998

A040273
A040273
A087447
A087446

Sep
Sep
Apr
Apr

CHLORHEXIDINE GLUCONATE

AT
AT
AT
AT
AT
AT
AT
AT
AT

SOLUTION; DENTAL
CHLORHEXIDINE GLUCONATE
HI TECH PHARMA
JOHN O BUTLER CO
LYNE
NOVEX
TEVA
WOCKHARDT
XTTRIUM
PERIDEX
+ 3M
PERIOGARD
COLGATE

TABLET; DENTAL

PERIOCHIP

XX + DEXCEL PHARMA

001
001
001
001
001
001
001

May
Nov
Dec
Nov
Dec
Mar
Jun

07,
29,
28,
14,
15,
03,
18,

1996
2005
1995
2000
1995
2004
2009

CHLOROPROCAINE HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
XX

INJECTABLE; INJECTION
CHLOROPROCAINE HYDROCHLORIDE
BEDFORD
2%
3%
HOSPIRA
2%
3%
NESACAINE
APP PHARMS
2%
NESACAINE-MPF
+ APP PHARMS
2%
+
3%
NESACAINE
+ APP PHARMS
1%

001
002
001
001

09,
09,
16,
16,

1998
1998
1982
1982

N009435 002
N009435 006
N009435 007

May 02, 1996

May 02, 1996

N009435 001

CHLOROQUINE PHOSPHATE
TABLET; ORAL
ARALEN
AA + SANOFI AVENTIS US
CHLOROQUINE PHOSPHATE
IMPAX LABS
AA
AA
IPCA LABS LTD
AA
AA
NATCO PHARMA LTD
AA
AA
AA + WEST WARD
AA

EQ 300MG BASE

N006002 001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A080880
A040516
A090610
A090249
A091621
A090612
A083082
A083082

150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
001
001
002

CHLOROTHIAZIDE
SUSPENSION; ORAL

DIURIL

XX + SALIX PHARMS

250MG/5ML

N011870 001

TABLET; ORAL
CHLOROTHIAZIDE
AB + MYLAN

250MG

A084388 001

Aug
Dec
Dec
Jan
Jan

29,
03,
03,
21,
21,

2003
2009
2009
2011
2011

Sep 17, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 93 (of 424)

CHLOROTHIAZIDE

TABLET; ORAL

CHLOROTHIAZIDE
MYLAN
AB
WEST WARD
AB
AB

500MG
250MG
500MG

A084217 001
A086028 001
A087736 001

Jul 14, 1982

Jul 14, 1982

EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL

A090896 001
A091546 001

Oct 16, 2009

Jul 26, 2011

EQ 500MG BASE/VIAL

N011145 005

CHLOROTHIAZIDE SODIUM
INJECTABLE; INJECTION
CHLOROTHIAZIDE SODIUM
APP PHARMS
AP
SUN PHARMA GLOBAL
AP
DIURIL
AP + LUNDBECK INC

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION; ORAL

ZUTRIPRO

XX + CYPRESS PHARM

4MG/5ML;5MG/5ML;60MG/5ML

N022439 001

Jun 08, 2011

A077273 002
A077273 001

Sep 24, 2007

Sep 24, 2007

A091632 001

Oct 01, 2010

N019111 001

Dec 31, 1987

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

CAPSULE, EXTENDED RELEASE; ORAL
TUSSICAPS
HI-TECH PHARMA CO
EQ 4MG MALEATE;EQ 5MG BITARTRATE
XX
EQ 8MG MALEATE;EQ 10MG BITARTRATE
XX +
SUSPENSION, EXTENDED RELEASE; ORAL
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
TRIS PHARMA INC
AB
EQ 8MG MALEATE/5ML;EQ 10MG
BITARTRATE/5ML
TUSSIONEX PENNKINETIC
AB + UCB INC
EQ 8MG MALEATE/5ML;EQ 10MG
BITARTRATE/5ML

CHLORPROMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION

CHLORPROMAZINE HYDROCHLORIDE

25MG/ML
XX + BAXTER HLTHCARE

A083329 001

TABLET; ORAL
CHLORPROMAZINE HYDROCHLORIDE
BP
SANDOZ
10MG
BP
25MG
BP
50MG
BP +
100MG
BP
200MG
BP
USL PHARMA
10MG
BP
25MG
BP
50MG
BP
100MG
BP
200MG

A080439
A080439
A080439
A080439
A080439
A083386
A084112
A084113
A084114
A084115

001
002
003
004
005
001
001
001
001
001

A088549
A088549
A088921
A088922
A088852
A088826

002
001
001
001
001
001

CHLORPROPAMIDE
TABLET; ORAL
CHLORPROPAMIDE
MYLAN
AB
AB
PLIVA
AB
AB
WATSON LABS
AB
AB

100MG
250MG
100MG
250MG
100MG
250MG

Jun
Jun
Apr
Apr
Sep
Sep

01,
01,
12,
12,
26,
26,

1984
1984
1985
1985
1984
1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 94 (of 424)

CHLORPROPAMIDE
TABLET; ORAL
DIABINESE
PFIZER
AB
AB +

100MG
250MG

N011641 003
N011641 006

25MG
50MG
25MG
50MG

A086831
A086831
A088902
A088903

002
001
001
001

Sep 19, 1985

Sep 19, 1985

15MG

N019574 001

Dec 20, 1988

15MG;0.1MG
15MG;0.2MG
15MG;0.3MG

A071325 003
A071325 002
A071325 001

Feb 09, 1987

Feb 09, 1987
Feb 09, 1987

500MG
500MG
500MG
500MG

A089895
A040137
A081040
A089859

May
Aug
Aug
May

500MG

N011529 002

Jun 15, 1987

375MG
750MG

A040861 001
A040861 002

Jun 01, 2010

Jun 01, 2010

CHLORTHALIDONE
TABLET; ORAL
CHLORTHALIDONE
MYLAN
AB
AB +
PLIVA
AB
AB
THALITONE
XX + MONARCH PHARMS

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

TABLET; ORAL
CLORPRES
MYLAN
XX
XX
XX +

CHLORZOXAZONE
TABLET; ORAL
CHLORZOXAZONE
BARR
AA
WATSON LABS
AA
AA
AA
PARAFON FORTE DSC
AA + JANSSEN R AND D
CHLORZOXAZONE
MIKART
XX
XX

001
001
001
001

04,
09,
22,
04,

1988
1996
1989
1988

CHOLESTYRAMINE
POWDER; ORAL
CHOLESTYRAMINE
PAR PHARM
AB
AB
AB + SANDOZ
AB
CHOLESTYRAMINE LIGHT
PAR PHARM
AB
AB
SANDOZ
AB
AB +
LOCHOLEST
SANDOZ
AB
AB
LOCHOLEST LIGHT
SANDOZ
AB
AB
PREVALITE
UPSHER SMITH
AB
AB

EQ
EQ
EQ
EQ

4GM
4GM
4GM
4GM

RESIN/SCOOPFUL
RESIN/PACKET
RESIN/PACKET
RESIN/SCOOPFUL

A077204
A077204
A074557
A074557

002
001
001
002

Aug
Aug
Aug
Aug

26,
26,
15,
15,

2005
2005
1996
1996

EQ
EQ
EQ
EQ

4GM
4GM
4GM
4GM

RESIN/PACKET
RESIN/SCOOPFUL
RESIN/SCOOPFUL
RESIN/PACKET

A077203
A077203
A074558
A074558

001
002
002
001

Aug
Aug
Aug
Aug

26,
26,
15,
15,

2005
2005
1996
1996

EQ 4GM RESIN/SCOOPFUL
EQ 4GM RESIN/PACKET

A074561 002
A074561 001

Aug 15, 1996

Aug 15, 1996

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

A074562 001
A074562 002

Aug 15, 1996

Aug 15, 1996

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

A073263 001
A073263 002

Feb 22, 1996

Oct 30, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 95 (of 424)

CHOLINE FENOFIBRATE
CAPSULE, DELAYED RELEASE; ORAL
TRILIPIX
ABBOTT LABS
EQ 45MG FENOFIBRIC ACID
XX
EQ 135MG FENOFIBRIC ACID
XX +

N022224 001
N022224 002

Dec 15, 2008

Dec 15, 2008

N021149 002

Oct 06, 2003

N018961 001

Jun 26, 1986

AEROSOL, METERED; INHALATION

ALVESCO
NYCOMED US
0.08MG/INH
XX
0.16MG/INH
XX +

N021658 002
N021658 003

Jan 10, 2008

Jan 10, 2008

SPRAY, METERED; NASAL

OMNARIS

XX + NYCOMED US

0.05MG/INH

N022004 001

Oct 20, 2006

0.77%
0.77%
0.77%
0.77%
0.77%

A076435
A078463
A090273
A077364
A076790

Dec
Dec
Nov
Mar
Apr

0.77%

N018748 001

Dec 30, 1982

0.77%
0.77%

A077896 001
A078266 001

Jun 10, 2008

Jan 07, 2009

0.77%

N020519 001

Jul 21, 1997

May
Nov
Feb
Feb

CHORIOGONADOTROPIN ALFA
INJECTABLE; SUBCUTANEOUS

OVIDREL

XX + EMD SERONO

EQ 0.25MG /0.5ML

CHROMIC CHLORIDE
INJECTABLE; INJECTION

CHROMIC CHLORIDE IN PLASTIC CONTAINER

XX + HOSPIRA
EQ 0.004MG CHROMIUM/ML

CICLESONIDE

CICLOPIROX

AB
AB
AB
AB
AB
AB

CREAM; TOPICAL
CICLOPIROX
ALTANA
G AND W LABS INC
GLENMARK PHARMS
PERRIGO
TARO
LOPROX
+ MEDICIS

GEL; TOPICAL
CICLOPIROX
NYCOMED US
AB
PADDOCK LLC
AB
LOPROX
AB + MEDICIS

001
001
001
001
001

29,
20,
10,
03,
12,

2004
2010
2009
2006
2005

1%
1%
1%
1%

A090146
A090490
A078594
A090269

AT

SHAMPOO; TOPICAL
CICLOPIROX
NYCOMED US
PADDOCK LLC
PERRIGO
TARO
LOPROX
+ MEDICIS

1%

N021159 001

Feb 28, 2003

AT
AT
AT
AT
AT
AT
AT
AT

SOLUTION; TOPICAL
CICLOPIROX
ACTAVIS MID ATLANTIC
APOTEX CORP
G AND W LABS
HI TECH PHARMA
PERRIGO NEW YORK
SYNERX PHARMA
TARO PHARM INDS
TEVA PHARMS

8%
8%
8%
8%
8%
8%
8%
8%

A078046
A078172
A078233
A078270
A077623
A078567
A078144
A078079

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

AT
AT
AT
AT

001
001
001
001

001
001
001
001
001
001
001
001

25,
24,
16,
23,

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

2010
2009
2010
2011

2007
2007
2007
2007
2007
2007
2007
2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 96 (of 424)

CICLOPIROX

AT
AT
AT
AT

AB
AB
AB
AB

SOLUTION; TOPICAL
CICLOPIROX
TOLMAR
VERSAPHARM
WATSON LABS
PENLAC
+ SANOFI AVENTIS US
SUSPENSION; TOPICAL
CICLOPIROX
ALTANA
PERRIGO NEW YORK
TARO
LOPROX
+ MEDICIS

8%
8%
8%

A077687 001
A078975 001
A078124 001

Sep 18, 2007

Feb 17, 2010
Sep 18, 2007

8%

N021022 001

Dec 17, 1999

0.77%
0.77%
0.77%

A076422 001
A077676 001
A077092 001

Aug 06, 2004

Dec 15, 2006
Aug 10, 2005

0.77%

N019824 001

Dec 30, 1988

EQ 75MG BASE/ML

N020638 001

Jun 26, 1996

CIDOFOVIR
INJECTABLE; INJECTION

VISTIDE

XX + GILEAD

CILASTATIN SODIUM; IMIPENEM

INJECTABLE; INJECTION
IMIPENEM AND CILASTATIN
ACS DOBFAR
AP
EQ
AP
EQ
HOSPIRA INC
AP
EQ
AP
EQ
AP
EQ
PRIMAXIN
MERCK
AP
EQ
AP +
EQ
AP
EQ
AP +
EQ
AP
EQ

250MG
500MG
250MG
500MG
500MG

BASE/VIAL;250MG/VIAL
BASE/VIAL;500MG/VIAL
BASE/VIAL;250MG/VIAL
BASE/VIAL;500MG/VIAL
BASE/VIAL;500MG/VIAL

A090577
A090577
A090825
A090825
A091007

001
002
001
002
001

Dec
Dec
Nov
Nov
Nov

21,
21,
16,
16,
16,

2011
2011
2011
2011
2011

250MG
250MG
500MG
500MG
500MG

BASE/VIAL;250MG/VIAL
BASE/VIAL;250MG/VIAL
BASE/VIAL;500MG/VIAL
BASE/VIAL;500MG/VIAL
BASE/VIAL;500MG/VIAL

A062756
N050587
A062756
N050587
N050630

001
001
002
002
001

Jan
Nov
Jan
Nov
Dec

08,
26,
08,
26,
14,

1987
1985
1987
1985
1990

50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG

A077019
A077019
A077030
A077030
A077708
A077708
A077150
A077022
A077323
A077323
A077898
A077898
A077024
A077024
A077310
A077021
A077027
A077027

001
002
001
002
001
002
001
001
002
001
001
002
001
002
001
001
001
002

Nov
Nov
Dec
Dec
Sep
Sep
Mar
Nov
Apr
Apr
Oct
Oct
May
May
Nov
Nov
Nov
Nov

23,
23,
10,
10,
28,
28,
11,
23,
20,
20,
29,
29,
17,
17,
08,
23,
24,
24,

2004
2004
2004
2004
2009
2009
2005
2004
2006
2006
2007
2007
2005
2005
2005
2004
2004
2004

50MG
100MG

N020863 001
N020863 002

CILOSTAZOL
TABLET; ORAL
CILOSTAZOL
ALPHAPHARM
AB
AB
APOTEX INC
AB
AB
BRECKENRIDGE PHARM
AB
AB
COREPHARMA
AB
AB
MYLAN
AB
AB
PLIVA HRVATSKA DOO
AB
AB
ROXANE
AB
AB
SANDOZ
AB
AB
TEVA
AB
AB
PLETAL
AB + OTSUKA
AB +

Jan 15, 1999

Jan 15, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 97 (of 424)

CIMETIDINE
TABLET; ORAL
CIMETIDINE
APOTEX
AB
AB
AB
AB
DAVA PHARMS INC
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
PLIVA
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
TAGAMET
GLAXOSMITHKLINE
AB
AB
AB
AB +

200MG
300MG
400MG
800MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG

A074890
A074890
A074890
A074890
A074340
A074340
A074339
A074424
A074424
A074424
A074424
A074246
A074246
A074246
A074246
A074568
A074568
A074568
A074566
A074506
A074506
A074506
A074506
A074151
A074151
A074151
A074463
A074349
A074349
A074349
A074316

001
002
003
004
001
002
001
001
002
003
004
001
002
003
004
001
002
003
001
001
002
003
004
001
002
003
001
001
002
003
001

Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jul
Jul
Jul
Jul
May
May
May
May
Feb
Feb
Feb
Feb
Jan
Jan
Jan
Jan
May
May
May
May
Aug
Aug
Aug
Feb

18,
18,
18,
18,
23,
23,
23,
28,
28,
28,
28,
17,
17,
17,
17,
27,
27,
27,
27,
24,
24,
24,
24,
17,
17,
17,
17,
30,
30,
30,
28,

1998
1998
1998
1998
1995
1995
1995
1995
1995
1995
1995
1994
1994
1994
1994
1997
1997
1997
1997
1996
1996
1996
1996
1994
1994
1994
1994
1996
1996
1996
1996

200MG
300MG
400MG
800MG

N017920
N017920
N017920
N017920

002
003
004
005

Dec 14, 1983

Apr 30, 1986

A074428 001
A074344 001
A074345 001

Apr 25, 1996

Jan 31, 1995
Jan 31, 1995

A074664
A075560
A074553
A074610
A074757

Oct
Mar
Jan
Sep
Oct

CIMETIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
CIMETIDINE HYDROCHLORIDE
DAVA PHARMS INC
AP
EQ 300MG BASE/2ML
HOSPIRA
AP
EQ 300MG BASE/2ML
AP
EQ 300MG BASE/2ML

AA
AA
AA
AA
AA

SOLUTION; ORAL
CIMETIDINE HYDROCHLORIDE
+ HI TECH PHARMA
EQ
NOVEX
EQ
PHARM ASSOC
EQ
TEVA
EQ
WOCKHARDT
EQ

300MG
300MG
300MG
300MG
300MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

001
001
001
001
001

28,
15,
27,
26,
17,

1997
2000
1997
1996
1997

CINACALCET HYDROCHLORIDE
TABLET; ORAL
SENSIPAR
AMGEN
XX
XX
XX +

EQ 30MG BASE
EQ 60MG BASE
EQ 90MG BASE

N021688 001
N021688 002
N021688 003

Mar 08, 2004

Mar 08, 2004
Mar 08, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 98 (of 424)

CIPROFLOXACIN
FOR SUSPENSION; ORAL
CIPRO
BAYER HLTHCARE
XX
XX +

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
CIPRO
+ BAYER HLTHCARE
+
CIPRO IN DEXTROSE 5% IN
+ BAYER HLTHCARE
+
CIPROFLOXACIN
CLARIS LIFESCIENCES

250MG/5ML
500MG/5ML

N020780 001
N020780 002

Sep 26, 1997

Sep 26, 1997

400MG/40ML (10MG/ML)
200MG/20ML (10MG/ML)
PLASTIC CONTAINER
200MG/100ML
400MG/200ML

N019847 001
N019847 002

Dec 26, 1990

Dec 26, 1990

N019857 001
N019857 002

Dec 26, 1990

Dec 26, 1990

A078062
A078062
A076717
A076717
A077245
A077245
A077782
A077782

001
002
001
002
002
001
002
001

Apr
Apr
Dec
Dec
Aug
Aug
Aug
Aug

29,
29,
22,
22,
28,
28,
28,
28,

2008
2008
2009
2009
2006
2006
2006
2006

A078252
A078252
A077888
A077888
A078024
A078024
A078431
A077753
A077753

001
002
001
002
001
002
001
001
002

Mar
Mar
Mar
Mar
Mar
Mar
Nov
Mar
Mar

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

2008
2008
2008
2008
2008
2008
2009
2008
2008

200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
HIKMA FARMACEUTICA
200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
HOSPIRA
400MG/40ML (10MG/ML)
200MG/20ML (10MG/ML)
TEVA PARENTERAL
400MG/40ML (10MG/ML)
200MG/20ML (10MG/ML)
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ACS DOBFAR INFO SA
200MG/100ML
400MG/200ML
BAXTER HLTHCARE
200MG/100ML
400MG/200ML
CLARIS LIFESCIENCES
200MG/100ML
400MG/200ML
HIKMA FARMACEUTICA
400MG/200ML
HOSPIRA
200MG/100ML
400MG/200ML

CIPROFLOXACIN HYDROCHLORIDE
OINTMENT; OPHTHALMIC

CILOXAN

XX + ALCON PHARMS LTD

AT
AT
AT
AT
AT
AT
AT
AT

EQ 0.3% BASE

SOLUTION/DROPS; OPHTHALMIC
CILOXAN
+ ALCON PHARMS LTD
EQ 0.3%
CIPROFLOXACIN HYDROCHLORIDE
AKORN INC
EQ 0.3%
APOTEX
EQ 0.3%
BAUSCH AND LOMB
EQ 0.3%
FDC LTD
EQ 0.3%
HITECH PHARMA
EQ 0.3%
NEXUS PHARMS
EQ 0.3%
PHARMAFORCE
EQ 0.3%

SOLUTION/DROPS; OTIC

CETRAXAL

XX + WRASER PHARMS

N020369 001

Mar 30, 1998

BASE

N019992 001

Dec 31, 1990

BASE
BASE
BASE
BASE
BASE
BASE
BASE

A076555
A075928
A076754
A077568
A076673
A077689
A078598

Dec
Jun
Jun
Jun
Jan
Dec
Jan

EQ 0.2% BASE

TABLET; ORAL
CIPRO
BAYER HLTHCARE
AB
EQ 100MG
AB
EQ 250MG
AB +
EQ 500MG
AB
EQ 750MG
CIPROFLOXACIN HYDROCHLORIDE
APOTEX
AB
EQ 250MG
AB
EQ 500MG

001
001
001
001
001
001
001

11,
09,
09,
30,
21,
13,
16,

2008
2004
2004
2008
2005
2006
2008

N021918 001

May 01, 2009

BASE
BASE
BASE
BASE

N019537
N019537
N019537
N019537

Apr
Oct
Oct
Oct

BASE
BASE

A076896 001
A076896 002

001
002
003
004

08,
22,
22,
22,

1996
1987
1987
1987

Nov 04, 2004

Nov 04, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 99 (of 424)

CIPROFLOXACIN HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
BX
BX
BX
BX

TABLET; ORAL
CIPROFLOXACIN HYDROCHLORIDE
APOTEX
EQ 750MG
AUROBINDO PHARMA
EQ 250MG
EQ 500MG
EQ 750MG
CARLSBAD
EQ 250MG
EQ 500MG
EQ 750MG
DR REDDYS LABS LTD
EQ 100MG
EQ 250MG
EQ 500MG
EQ 750MG
HIKMA
EQ 250MG
EQ 500MG
EQ 750MG
IVAX SUB TEVA PHARMS EQ 250MG
EQ 500MG
EQ 750MG
MYLAN
EQ 100MG
EQ 250MG
EQ 250MG
EQ 500MG
EQ 500MG
EQ 750MG
EQ 750MG
RANBAXY
EQ 250MG
EQ 500MG
EQ 750MG
TARO
EQ 100MG
EQ 250MG
EQ 500MG
EQ 750MG
UNIQUE PHARM LABS
EQ 250MG
EQ 500MG
EQ 750MG
WATSON LABS
EQ 100MG
EQ 250MG
EQ 500MG
EQ 750MG
CIPROFLOXACIN HYDROCHLORIDE
PLIVA
EQ 100MG
EQ 250MG
EQ 500MG
EQ 750MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A076896
A077859
A077859
A077859
A076126
A076126
A076126
A075593
A075593
A075593
A075593
A076558
A076558
A076558
A076089
A076089
A076089
A075817
A075685
A075817
A075685
A075817
A075685
A075817
A075747
A075747
A075747
A076912
A076912
A076912
A076912
A076639
A076639
A076639
A076794
A076794
A076794
A076794

003
001
002
003
002
003
004
002
003
004
001
002
003
004
002
003
004
001
002
002
003
003
001
004
001
002
003
001
002
003
004
001
002
003
001
002
003
004

Nov
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Feb
Oct
Oct
Oct
Sep
Sep
Sep
Feb
Jun
Jun
Jun

04,
26,
26,
26,
09,
09,
09,
09,
09,
09,
09,
09,
09,
09,
09,
09,
09,
25,
09,
09,
09,
09,
09,
09,
09,
09,
09,
18,
06,
06,
06,
10,
10,
10,
10,
09,
09,
09,

2004
2007
2007
2007
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2007
2004
2004
2004
2004
2004
2004
2004
2004
2004
2005
2004
2004
2004
2004
2004
2004
2005
2004
2004
2004

BASE
BASE
BASE
BASE

A076426
A076426
A076426
A076426

001
002
003
004

Jun
Jun
Jun
Jun

15,
15,
15,
15,

2005
2005
2005
2005

CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE

SUSPENSION/DROPS; OTIC

CIPRO HC

XX + ALCON PHARMS LTD

EQ 0.2% BASE;1%

N020805 001

Feb 10, 1998

287.5MG BASE
574.9MG BASE

N021473 001
N021473 002

Dec 13, 2002

Aug 28, 2003

287.5MG BASE
574.9MG BASE

A078166 002
A078166 001

Nov 27, 2007

Nov 27, 2007

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

AB
AB
AB
AB

TABLET, EXTENDED RELEASE; ORAL

CIPRO XR
+ BAYER HLTHCARE
212.6MG;EQ
+
425.2MG;EQ
CIPROFLOXACIN EXTENDED RELEASE
ANCHEN PHARMS
212.6MG;EQ
425.2MG;EQ

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 100 (of 424)

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

AB
AB
AB
AB
AB
AB

TABLET, EXTENDED RELEASE; ORAL

CIPROFLOXACIN EXTENDED RELEASE
DR REDDYS LABS LTD
212.6MG;EQ
425.2MG;EQ
MYLAN
212.6MG;EQ
425.2MG;EQ
WATSON LABS FLORIDA
212.6MG;EQ
425.2MG;EQ

287.5MG
574.9MG
287.5MG
574.9MG
287.5MG
574.9MG

BASE
BASE
BASE
BASE
BASE
BASE

A077902
A077701
A078183
A078183
A077417
A077809

001
001
001
002
001
001

Oct
Mar
Mar
Mar
Nov
Nov

31,
26,
22,
22,
30,
30,

2007
2007
2007
2007
2010
2010

CIPROFLOXACIN; DEXAMETHASONE
SUSPENSION/DROPS; OTIC

CIPRODEX

XX + ALCON PHARMS LTD

0.3%;0.1%

N021537 001

Jul 18, 2003

N020551 001

Dec 15, 1995

N020551 003
N020551 002

Dec 15, 1995

Dec 15, 1995

A074735
A075036
A074656
A074814

Jul
Nov
May
May

CISATRACURIUM BESYLATE
INJECTABLE; INJECTION

NIMBEX

EQ 2MG BASE/ML
XX + ABBOTT
NIMBEX PRESERVATIVE FREE
EQ 2MG BASE/ML
XX + ABBOTT
EQ 10MG BASE/ML
XX +

CISPLATIN

AP
AP
AP
AP

INJECTABLE; INJECTION
CISPLATIN
+ APP PHARMS
BEDFORD
PHARMACHEMIE
TEVA PARENTERAL

1MG/ML
1MG/ML
1MG/ML
1MG/ML

001
001
001
001

16,
07,
16,
16,

1999
2000
2000
2000

CITALOPRAM HYDROBROMIDE
CAPSULE; ORAL
CITALOPRAM HYDROBROMIDE
ALPHAPHARM
EQ 10MG BASE
XX
EQ 20MG BASE
XX
EQ 40MG BASE
XX +

AA
AA
AA
AA

SOLUTION; ORAL
CELEXA
+ FOREST LABS
CITALOPRAM HYDROBROMIDE
AUROBINDO PHARMA LTD
ROXANE
SILARX

TABLET; ORAL
CELEXA
FOREST LABS
AB
AB
AB +
CITALOPRAM HYDROBROMIDE
ALPHAPHARM
AB
AB
AB
AMNEAL PHARMS NY
AB
AB
AB
APOTEX INC
AB
AB
AB

A077668 001
A077668 002
A077668 003

Feb 28, 2007

Feb 28, 2007
Feb 28, 2007

EQ 10MG BASE/5ML

N021046 001

Dec 22, 1999

EQ 10MG BASE/5ML
EQ 10MG BASE/5ML
EQ 10MG BASE/5ML

A077812 001
A077043 001
A077629 001

Aug 28, 2006

Dec 13, 2004
Jun 15, 2006

EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE

N020822 001
N020822 002
N020822 003

Apr 27, 2000

Jul 17, 1998
Jul 17, 1998

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A077037
A077037
A077037
A077289
A077289
A077289
A077046
A077046
A077046

Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov

10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
002
003
001
002
003
001
002
003

05,
05,
05,
30,
30,
30,
24,
24,
24,

2004
2004
2004
2006
2006
2006
2004
2004
2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 101 (of 424)

CITALOPRAM HYDROBROMIDE
TABLET; ORAL
CITALOPRAM HYDROBROMIDE
AUROBINDO
EQ
AB
EQ
AB
EQ
AB
CARACO
EQ
AB
EQ
AB
EQ
AB
COREPHARMA
EQ
AB
EQ
AB
EQ
AB
DR REDDYS LABS LTD
EQ
AB
EQ
AB
EQ
AB
EPIC PHARMA
EQ
AB
EQ
AB
EQ
AB
GLENMARK GENERICS
EQ
AB
EQ
AB
EQ
AB
INVAGEN PHARMS
EQ
AB
EQ
AB
EQ
AB
IVAX SUB TEVA PHARMS EQ
AB
EQ
AB
EQ
AB
MYLAN
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
NATCO PHARMA LTD
EQ
AB
EQ
AB
PLIVA
EQ
AB
EQ
AB
EQ
AB
SANDOZ
EQ
AB
EQ
AB
EQ
AB
TORRENT PHARMS
EQ
AB
EQ
AB
EQ
AB
WATSON LABS
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB

10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
10MG
20MG
20MG
40MG
40MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
10MG
20MG
20MG
40MG
40MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A077031
A077031
A077031
A077032
A077032
A077032
A077036
A077036
A077036
A077038
A077038
A077038
A077045
A077045
A077045
A077654
A077654
A077654
A077534
A077534
A077534
A077048
A077048
A077048
A077039
A077042
A077039
A077042
A077039
A077042
A077141
A077141
A077232
A077232
A077232
A077035
A077035
A077035
A078216
A078216
A078216
A077034
A077044
A077034
A077044
A077034
A077044

001
002
003
001
002
003
001
002
003
001
002
003
003
002
001
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
002
001
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003

Oct
Oct
Oct
Nov
Nov
Nov
Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Feb
Feb
Feb
Oct
Oct
Oct
Nov
Nov
Nov
Feb
Nov
Feb
Nov
Feb
Nov
Apr
Apr
Oct
Oct
Oct
Oct
Oct
Oct
Mar
Mar
Mar
Jun
Nov
Jun
Nov
Jun
Nov

28,
28,
28,
12,
12,
12,
28,
28,
28,
28,
28,
28,
29,
29,
29,
27,
27,
27,
03,
03,
03,
16,
16,
16,
03,
05,
03,
05,
03,
05,
10,
10,
31,
31,
31,
28,
28,
28,
27,
27,
27,
30,
05,
30,
05,
30,
05,

2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2005
2005
2005
2009
2009
2009
2006
2006
2006
2004
2004
2004
2005
2004
2005
2004
2005
2004
2008
2008
2005
2005
2005
2004
2004
2004
2007
2007
2007
2005
2004
2005
2004
2005
2004

CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE

SOLUTION; IRRIGATION

RENACIDIN

XX + UNITED GUARDIAN

6.602GM/100ML;198MG/100ML;3.177GM/100ML

N019481 001

Oct 02, 1990

N021314 001

Dec 17, 2002

CITRIC ACID; UREA C-13

FOR SOLUTION, TABLET, FOR SOLUTION; ORAL

IDKIT:HP

XX + EXALENZ BIOSCIENCE
N/A,4GM;75MG,N/A

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 102 (of 424)

CLADRIBINE

AP
AP
AP
AP

INJECTABLE; INJECTION
CLADRIBINE
APP PHARMS
BEDFORD
ONCO THERAPIES LTD
LEUSTATIN
+ JANSSEN PHARMS

1MG/ML
1MG/ML
1MG/ML

A076571 001
A075405 001
A200510 001

Apr 22, 2004

Feb 28, 2000
Oct 06, 2011

1MG/ML

N020229 001

Feb 26, 1993

125MG/5ML
250MG/5ML

N050698 001
N050698 002

Dec 23, 1993

Dec 23, 1993

125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML

A065382
A065382
A065283
A065283

Aug
Aug
Sep
Sep

250MG
500MG

N050662 001
N050662 002

Oct 31, 1991

Oct 31, 1991

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

A065384
A065384
A065195
A065195
A065174
A065174
A065178
A065178
A065144
A065136
A065155
A065155
A065266
A065266

Aug
Aug
Mar
Mar
Sep
Sep
May
May
Oct
Aug
May
May
May
May

CLARITHROMYCIN
FOR SUSPENSION; ORAL
BIAXIN
ABBOTT
AB
AB +
CLARITHROMYCIN
RANBAXY
AB
AB
SANDOZ
AB
AB
TABLET; ORAL
BIAXIN
AB + ABBOTT
AB +
CLARITHROMYCIN
APOTEX CORP
AB
AB
MYLAN
AB
AB
RANBAXY
AB
AB
ROXANE
AB
AB
SANDOZ
AB
AB
TEVA
AB
AB
WOCKHARDT
AB
AB

AB
AB
AB
AB

TABLET, EXTENDED RELEASE;

BIAXIN XL
+ ABBOTT
CLARITHROMYCIN
SANDOZ
TEVA
WATSON LABS FLORIDA

001
002
002
003

001
002
001
002
001
002
002
001
001
001
001
002
001
002

30,
30,
04,
04,

20,
20,
11,
11,
24,
24,
25,
25,
18,
25,
31,
31,
31,
31,

2007
2007
2007
2007

2007
2007
2005
2005
2004
2004
2004
2004
2005
2005
2005
2005
2006
2006

ORAL
500MG

N050775 001

Mar 03, 2000

500MG
500MG
500MG

A065250 001
A065154 001
A065145 001

Aug 25, 2005

May 18, 2005
Jun 24, 2004

N050590
A062691
N050590
N050590

Aug
Dec
Apr
Apr

CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM

INJECTABLE; INJECTION

TIMENTIN

EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL

XX + GLAXOSMITHKLINE
EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL
XX
EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL
XX +
EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL
XX +
TIMENTIN IN PLASTIC CONTAINER
EQ 100MG BASE/100ML;EQ 3GM BASE/100ML
XX + GLAXOSMITHKLINE

003
001
001
002

N050658 001

18,
19,
01,
01,

1987
1986
1985
1985

Dec 15, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 103 (of 424)

CLEMASTINE FUMARATE

AA
AA
AA
AA

SYRUP; ORAL
CLEMASTINE FUMARATE
NOVEX
SILARX
+ TEVA
WOCKHARDT

TABLET; ORAL
CLEMASTINE FUMARATE
SANDOZ
AB
AB + TEVA

EQ
EQ
EQ
EQ

0.5MG
0.5MG
0.5MG
0.5MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A075703
A074884
A073399
A074863

001
001
001
001

Nov
Dec
Jun
Mar

27,
17,
30,
13,

2000
1997
1994
1998

2.68MG
2.68MG

A073459 001
A073283 001

Oct 31, 1993

Jan 31, 1992

25MG/50ML (0.5MG/ML)
50MG/100ML (0.5MG/ML)

N022156 001
N022156 002

Aug 01, 2008

Aug 01, 2008

75MG BASE
150MG BASE
300MG BASE

N050162 001
N050162 002
N050162 003

Apr 14, 1988

150MG BASE
300MG BASE
150MG BASE
300MG BASE
75MG BASE
150MG BASE
300MG BASE
75MG BASE
150MG BASE
300MG BASE
150MG BASE
300MG BASE
150MG BASE
300MG BASE
150MG BASE
300MG BASE
75MG BASE
150MG BASE
300MG BASE

A065442
A065442
A065194
A065194
A065242
A065242
A065243
A091225
A091225
A091225
A065061
A065061
A063029
A063029
A063083
A063083
A065217
A065217
A065217

Aug
Aug
Mar
Mar
Aug
Aug
Aug
May
May
May
Feb
Feb
Sep
Aug
Jul
Mar
Jan
Jan
Jan

CLEVIDIPINE BUTYRATE
EMULSION; INTRAVENOUS

CLEVIPREX

XX + MEDICINES CO
XX +

CLINDAMYCIN HYDROCHLORIDE
CAPSULE; ORAL
CLEOCIN HYDROCHLORIDE
PHARMACIA AND UPJOHN EQ
AB
AB
EQ
AB +
EQ
CLINDAMYCIN HYDROCHLORIDE
AUROBINDO PHARMA
AB
EQ
AB
EQ
COREPHARMA
AB
EQ
AB
EQ
LANNETT
AB
EQ
AB
EQ
AB
EQ
MATRIX LABS LTD
AB
EQ
AB
EQ
AB
EQ
RANBAXY
AB
EQ
AB
EQ
TEVA
AB
EQ
AB
EQ
WATSON LABS
AB
EQ
AB
EQ
ZYDUS PHARMS USA
AB
EQ
AB
EQ
AB
EQ

001
002
001
002
001
002
001
001
002
003
001
002
001
002
001
002
001
002
003

26,
26,
22,
22,
12,
12,
12,
31,
31,
31,
02,
02,
20,
05,
31,
18,
31,
31,
31,

2009
2009
2004
2004
2005
2005
2005
2011
2011
2011
2001
2001
1989
2005
1991
2003
2005
2005
2005

CLINDAMYCIN PALMITATE HYDROCHLORIDE

FOR SOLUTION; ORAL
CLEOCIN
AA + PHARMACIA AND UPJOHN EQ 75MG BASE/5ML
CLINDAMYCIN PALMITATE HYDROCHLORIDE
PADDOCK LABS
AA
EQ 75MG BASE/5ML

A062644 001

Apr 07, 1986

A090902 001

Jul 07, 2010

1%

A090785 001

Mar 31, 2010

1%

N050801 001

Oct 22, 2004

CLINDAMYCIN PHOSPHATE
AEROSOL, FOAM; TOPICAL
CLINDAMYCIN PHOSPHATE
PERRIGO UK FINCO
AT
EVOCLIN
AT + STIEFEL LABS INC

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 104 (of 424)

CLINDAMYCIN PHOSPHATE
CREAM; VAGINAL
CLEOCIN
AB + PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE
NYCOMED US
AB
CLINDESSE
XX + KV PHARM
GEL; TOPICAL
CLEOCIN T
AB + PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE
ALTANA
AB
CLINDAGEL
BT + GALDERMA LABS LP

EQ 2% BASE

N050680 002

Mar 02, 1998

EQ 2% BASE

A065139 001

Dec 27, 2004

EQ 2% BASE

N050793 001

Nov 30, 2004

EQ 1% BASE

N050615 001

Jan 07, 1987

EQ 1% BASE

A064160 001

Jan 28, 2000

EQ 1% BASE

N050782 001

Nov 27, 2000

A062803 001
N050441 001

Oct 16, 1987

A065346
A065347
A062889
A065206
A062800
A062801
A062943
A090108
A090109

Mar
May
Apr
Sep
Jul
Jul
Sep
Sep
Sep

INJECTABLE; INJECTION
CLEOCIN PHOSPHATE
PHARMACIA AND UPJOHN EQ 150MG BASE/ML
AP
AP +
EQ 150MG BASE/ML
CLINDAMYCIN PHOSPHATE
APP PHARMS
AP
EQ 150MG BASE/ML
AP
EQ 150MG BASE/ML
BAXTER HLTHCARE
AP
EQ 150MG BASE/ML
BEDFORD
AP
EQ 150MG BASE/ML
HOSPIRA
AP
EQ 150MG BASE/ML
AP
EQ 150MG BASE/ML
AP
EQ 150MG BASE/ML
SAGENT STRIDES
AP
EQ 150MG BASE/ML
AP
EQ 150MG BASE/ML
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
XX + PHARMACIA AND UPJOHN EQ 6MG BASE/ML
EQ 12MG BASE/ML
XX +
EQ 18MG BASE/ML
XX +
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
EQ 900MG BASE/100ML
XX + ABRAXIS PHARM
LOTION; TOPICAL
CLEOCIN T
AB + PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE
ALTANA
AB

AT
AT
AT
AT
AT
AT
AT

SOLUTION; TOPICAL
CLEOCIN T
+ PHARMACIA AND UPJOHN
CLINDA-DERM
PADDOCK LLC
CLINDAMYCIN PHOSPHATE
ALTANA
FOUGERA
PERRIGO NEW YORK
TARO PHARM INDS
WOCKHARDT

SUPPOSITORY; VAGINAL

CLEOCIN

XX + PHARMACIA AND UPJOHN

SWAB; TOPICAL
CLEOCIN
PHARMACIA AND UPJOHN
AT
CLINDAMYCIN PHOSPHATE
PERRIGO NEW YORK
AT

001
001
001
001
001
001
001
001
001

29,
09,
25,
24,
24,
24,
29,
30,
30,

2007
2007
1988
2004
1987
1987
1988
2011
2011

N050639 001
N050639 002
N050639 003

Aug 30, 1989

Aug 30, 1989
Apr 10, 1991

N050635 001

Dec 22, 1989

EQ 1% BASE

N050600 001

May 31, 1989

EQ 1% BASE

A065067 001

Jan 31, 2002

EQ 1% BASE

N050537 001

EQ 1% BASE

A063329 001

Sep 30, 1992

EQ
EQ
EQ
EQ
EQ

A065254
A064159
A064050
A065184
A063304

Feb
Jun
Nov
Mar
Jul

1%
1%
1%
1%
1%

BASE
BASE
BASE
BASE
BASE

001
001
001
001
001

14,
05,
30,
31,
15,

2006
1997
1995
2004
1997

100MG

N050767 001

Aug 13, 1999

EQ 1% BASE

N050537 002

Feb 22, 1994

EQ 1% BASE

A065049 001

May 25, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 105 (of 424)

CLINDAMYCIN PHOSPHATE
SWAB; TOPICAL
CLINDAMYCIN PHOSPHATE
VERSAPHARM
AT
CLINDETS
PERRIGO
AT

EQ 1% BASE

A065513 001

Jun 17, 2010

EQ 1% BASE

A064136 001

Sep 30, 1996

1.2%;0.025%

N050803 001

Jul 16, 2010

1.2%;0.025%

N050802 001

Nov 07, 2006

5MG
10MG
20MG

N202067 001
N202067 002
N202067 003

Oct 21, 2011

Oct 21, 2011
Oct 21, 2011

0.05%

A077763 001

Mar 10, 2008

0.05%

N021142 001

May 26, 2000

0.05%

N022013 001

Jan 12, 2007

A074392 001
A074249 001
A074087 001

Sep 30, 1996

Jul 08, 1996
Feb 16, 1994

A074220 001

May 16, 1997

N019322 001

Dec 27, 1985

A075430 001
A075633 001

May 26, 1999

May 17, 2000

A075325 001

Dec 24, 1998

N020340 001

Jun 17, 1994

0.05%
0.05%
0.05%

A075368 001
A075027 001
A075279 001

Feb 15, 2000

Oct 31, 1997
May 28, 1999

0.05%

A076141 001

Apr 12, 2002

0.05%

N020337 001

Apr 29, 1994

0.05%

A078223 001

Dec 04, 2008

0.05%

N021535 001

Jul 24, 2003

CLINDAMYCIN PHOSPHATE; TRETINOIN

GEL; TOPICAL
VELTIN
BX
STIEFEL GSK
ZIANA
BX + MEDICIS

CLOBAZAM
TABLET; ORAL
ONFI
XX
LUNDBECK INC
XX
XX +

CLOBETASOL PROPIONATE
AEROSOL, FOAM; TOPICAL
CLOBETASOL PROPIONATE
PERRIGO ISRAEL
AB
OLUX
AB + STIEFEL LABS INC
OLUX E
XX + STIEFEL LABS INC

CREAM; TOPICAL
CLOBETASOL PROPIONATE
FOUGERA
AB1
0.05%
TARO
AB1
0.05%
TEVA PHARMS
AB1
0.05%
CORMAX
HI TECH PHARMA
AB1
0.05%
TEMOVATE
AB1 + NYCOMED US
0.05%
CLOBETASOL PROPIONATE (EMOLLIENT)
ALTANA
AB2
0.05%
TARO
AB2
0.05%
EMBELINE E
HI TECH PHARMA
AB2
0.05%
TEMOVATE E
AB2 + FOUGERA PHARMS
0.05%

AB
AB
AB
AB
AB

GEL; TOPICAL
CLOBETASOL PROPIONATE
ALTANA
PERRIGO
TARO
EMBELINE
HI TECH PHARMA
TEMOVATE
+ NYCOMED US

LOTION; TOPICAL
CLOBETASOL PROPIONATE
ACTAVIS MID ATLANTIC
AB
CLOBEX
AB + GALDERMA LABS LP

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 106 (of 424)

CLOBETASOL PROPIONATE

AB
AB
AB
AB
AB

OINTMENT; TOPICAL
CLOBETASOL PROPIONATE
NYCOMED US
TARO
TEVA PHARMS
EMBELINE
HI TECH PHARMA
TEMOVATE
+ NYCOMED US

SHAMPOO; TOPICAL
CLOBETASOL PROPIONATE
ACTAVIS MID ATLANTIC
AB
CLOBEX
AB + GALDERMA LABS
SOLUTION; TOPICAL
CLOBETASOL PROPIONATE
NYCOMED US
AT
TARO
AT
AT
TOLMAR
AT
WOCKHARDT
AT
EMBELINE
HI TECH PHARMA
AT
TEMOVATE
AT + NYCOMED US
SPRAY; TOPICAL
CLOBETASOL PROPIONATE
PADDOCK LLC
AT
CLOBEX
AT + GALDERMA LABS LP

0.05%
0.05%
0.05%

A074407 001
A074248 001
A074089 001

Feb 23, 1996

Jul 12, 1996
Feb 16, 1994

0.05%

A074221 001

Mar 31, 1995

0.05%

N019323 001

Dec 27, 1985

0.05%

A078854 001

Jun 07, 2011

0.05%

N021644 001

Feb 05, 2004

0.05%
0.05%
0.05%
0.05%
0.05%

A075391
A075224
A075363
A076977
A075205

Feb
Nov
Dec
Aug
Nov

0.05%

A074222 001

Dec 06, 1995

0.05%

N019966 001

Feb 22, 1990

0.05%

A090898 001

Jun 16, 2011

0.05%

N021835 001

Oct 27, 2005

0.1%

N017765 001

001
001
001
001
001

08,
16,
29,
05,
13,

1999
1998
2000
2005
1998

CLOCORTOLONE PIVALATE
CREAM; TOPICAL

CLODERM

XX + PROMIUS PHARMA LLC

CLOFARABINE
INJECTABLE; IV (INFUSION)

CLOLAR

20MG/20ML (1MG/ML)
XX + GENZYME

N021673 001

Dec 28, 2004

50MG

N019500 002

Dec 15, 1986

50MG

N016131 002

50MG

A075528 001

Aug 30, 1999

50MG

N018361 001

Mar 22, 1982

CLOFAZIMINE
CAPSULE; ORAL

LAMPRENE

XX + NOVARTIS

CLOMIPHENE CITRATE
TABLET; ORAL
CLOMID
AB + SANOFI AVENTIS US
CLOMIPHENE CITRATE
PAR PHARM
AB
SEROPHENE
EMD SERONO
AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 107 (of 424)

CLOMIPRAMINE HYDROCHLORIDE
CAPSULE; ORAL
ANAFRANIL
MALLINCKRODT LLC
AB
25MG
AB +
50MG
AB
75MG
CLOMIPRAMINE HYDROCHLORIDE
MYLAN
AB
25MG
AB
50MG
AB
75MG
SANDOZ
AB
25MG
AB
50MG
AB
75MG
TARO
AB
25MG
AB
50MG
AB
75MG
TEVA
AB
25MG
AB
50MG
AB
75MG

N019906 001
N019906 002
N019906 003

Dec 29, 1989

Dec 29, 1989
Dec 29, 1989

A074947
A074947
A074947
A074364
A074364
A074364
A074694
A074694
A074694
A074958
A074958
A074958

001
002
003
001
002
003
001
002
003
001
002
003

Apr
Apr
Apr
Mar
Mar
Mar
Dec
Dec
Dec
Aug
Aug
Aug

30,
30,
30,
29,
29,
29,
31,
31,
31,
26,
26,
26,

1998
1998
1998
1996
1996
1996
1996
1996
1996
1997
1997
1997

0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG

A077147
A077147
A077147
A074869
A074869
A074869
A074940
A074940
A074940
A075468
A075468
A075468
A075423
A075423
A075423
A075150
A075150
A075150
A074979
A074979
A074979
A074569
A074569
A074569
A077856
A077856
A077856
A074964
A074964
A074964

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

May
May
May
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Oct
Oct
Oct
Aug
Aug
Aug
Sep
Sep
Sep
Jun
Jun
Jun
Dec
Dec
Dec

02,
02,
02,
31,
31,
31,
30,
30,
30,
06,
06,
06,
27,
27,
27,
05,
05,
05,
29,
29,
29,
10,
10,
10,
28,
28,
28,
30,
30,
30,

2005
2005
2005
1996
1996
1996
1997
1997
1997
2000
2000
2000
2001
2001
2001
1998
1998
1998
1997
1997
1997
1996
1996
1996
2006
2006
2006
1997
1997
1997

0.5MG
1MG
2MG

N017533 001
N017533 002
N017533 003

CLONAZEPAM
TABLET; ORAL
CLONAZEPAM
ACCORD HLTHCARE INC
AB
AB
AB
ACTAVIS ELIZABETH
AB
AB
AB
ALPHAPHARM
AB
AB
AB
APOTEX
AB
AB
AB
CARACO
AB
AB
AB
MYLAN
AB
AB
AB
SANDOZ
AB
AB
AB
TEVA
AB
AB
AB
VINTAGE PHARMS
AB
AB
AB
WATSON LABS
AB
AB
AB
KLONOPIN
ROCHE
AB
AB +
AB

TABLET, ORALLY DISINTEGRATING; ORAL

CLONAZEPAM
BARR
AB
0.125MG

A077194 001

Aug 10, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 108 (of 424)

CLONAZEPAM
TABLET, ORALLY DISINTEGRATING; ORAL
CLONAZEPAM
BARR
AB
0.25MG
AB
0.5MG
AB
1MG
AB
2MG
PAR PHARM
AB
0.125MG
AB
0.25MG
AB
0.5MG
AB +
1MG
AB
2MG

A077194
A077194
A077194
A077194
A077171
A077171
A077171
A077171
A077171

002
003
004
005
001
002
003
004
005

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug

10,
10,
10,
10,
03,
03,
03,
03,
03,

2005
2005
2005
2005
2005
2005
2005
2005
2005

CLONIDINE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

FILM, EXTENDED RELEASE; TRANSDERMAL

CATAPRES-TTS-1
BOEHRINGER INGELHEIM 0.1MG/24HR
CATAPRES-TTS-2
BOEHRINGER INGELHEIM 0.2MG/24HR
CATAPRES-TTS-3
+ BOEHRINGER INGELHEIM 0.3MG/24HR
CLONIDINE
AVEVA
0.1MG/24HR
0.2MG/24HR
0.3MG/24HR
BARR
0.1MG/24HR
0.2MG/24HR
0.3MG/24HR
MYLAN TECHNOLOGIES
0.1MG/24HR
0.2MG/24HR
0.3MG/24HR

N018891 001

Oct 10, 1984

N018891 002

Oct 10, 1984

N018891 003

Oct 10, 1984

A076157
A076157
A076157
A079090
A079090
A079090
A076166
A076166
A076166

001
002
003
001
002
003
001
002
003

Aug
Aug
Aug
Aug
Aug
Aug
Jul
Jul
Jul

18,
18,
18,
20,
20,
20,
16,
16,
16,

2009
2009
2009
2010
2010
2010
2010
2010
2010

A200673
A200673
A200300
A200300
A091104
A091104

001
002
001
002
001
002

Jul
Jul
Jan
Jan
Oct
Oct

08,
08,
26,
26,
08,
08,

2011
2011
2011
2011
2009
2009

CLONIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
CLONIDINE HYDROCHLORIDE
APP PHARMS
AP
1MG/10ML (0.1MG/ML)
AP
5MG/10ML (0.5MG/ML)
HIKMA FARMACEUTICA
AP
1MG/10ML (0.1MG/ML)
AP
5MG/10ML (0.5MG/ML)
LUITPOLD
AP
1 MG/10 ML (0.1 MG/ML)
AP
5 MG/10 ML (0.5 MG/ML)
DURACLON
BIONICHE PHARMA USA
AP
1 MG/10 ML (0.1 MG/ML)
AP +
5 MG/10 ML (0.5 MG/ML)
TABLET; ORAL
CATAPRES
BOEHRINGER INGELHEIM
AB
AB
AB +
CLONIDINE HYDROCHLORIDE
ACTAVIS ELIZABETH
AB
AB
AB
ALEMBIC PHARMS LTD
AB
AB
AB
DAVA PHARMS INC
AB
AB
AB
IMPAX LABS
AB

N020615 001
N020615 002

0.1MG
0.2MG
0.3MG

N017407 001
N017407 002
N017407 003

0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG
0.2MG
0.3MG
0.1MG

A070974
A070975
A070976
A091368
A091368
A091368
A071783
A071784
A071785
A078099

001
001
001
001
002
003
001
001
001
001

Oct 02, 1996

Apr 27, 1999

Dec
Dec
Dec
Dec
Dec
Dec
Apr
Apr
Apr
Aug

16,
16,
16,
06,
06,
06,
05,
05,
05,
27,

1986
1986
1986
2011
2011
2011
1988
1988
1988
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 109 (of 424)

CLONIDINE HYDROCHLORIDE
TABLET; ORAL
CLONIDINE HYDROCHLORIDE
IMPAX LABS
AB
0.2MG
AB
0.3MG
MUTUAL PHARM
AB
0.1MG
AB
0.2MG
AB
0.3MG
MYLAN
AB
0.1MG
AB
0.2MG
AB
0.3MG
UNICHEM
AB
0.1MG
AB
0.2MG
AB
0.3MG
VINTAGE
AB
0.1MG
AB
0.2MG
AB
0.3MG
WATSON LABS
AB
0.3MG

A078099
A078099
A070925
A070924
A070923
A070317
A070317
A070317
A078895
A078895
A078895
A077901
A077901
A077901
A070963

TABLET, EXTENDED RELEASE; ORAL

KAPVAY

0.1MG
XX + SHIONOGI INC

N022331 003

Sep 28, 2010

N020839 001
N020839 002

Nov 17, 1997

Sep 20, 2007

A071858
A071858
A071858
A076911
A076911
A076911
A075731
A075731
A075731
A071852
A071853
A071854

Jul
Jul
Jul
Sep
Sep
Sep
Apr
Apr
Apr
Feb
Feb
Feb

002
003
001
001
001
002
003
001
001
002
003
001
002
003
001

Aug
Aug
Sep
Sep
Sep
Jul
Jun
Jun
Aug
Aug
Aug
Mar
Mar
Mar
Jul

27,
27,
04,
04,
04,
09,
09,
09,
26,
26,
26,
09,
09,
09,
08,

2009
2009
1987
1987
1987
1987
1987
1987
2009
2009
2009
2007
2007
2007
1986

CLOPIDOGREL BISULFATE
TABLET; ORAL
PLAVIX
SANOFI AVENTIS US
XX
XX +

EQ 75MG BASE
EQ 300MG BASE

CLORAZEPATE DIPOTASSIUM
TABLET; ORAL
CLORAZEPATE DIPOTASSIUM
MYLAN
AB
3.75MG
AB
7.5MG
AB
15MG
RANBAXY
AB
3.75MG
AB
7.5MG
AB
15MG
TARO
AB
3.75MG
AB
7.5MG
AB
15MG
WATSON LABS
AB
3.75MG
AB
7.5MG
AB
15MG
GEN-XENE
ALRA
AB
3.75MG
AB
7.5MG
AB
15MG
TRANXENE
LUNDBECK INC
AB
3.75MG
AB
7.5MG
AB +
15MG

002
003
001
001
002
003
003
002
001
001
001
001

A071787 001
A071788 001
A071789 001

17,
17,
17,
29,
29,
29,
27,
27,
27,
09,
09,
09,

1987
1987
1987
2004
2004
2004
2000
2000
2000
1988
1988
1988

Apr 26, 1988

Apr 26, 1988
Apr 26, 1988

N017105 006
N017105 007
N017105 008

CLOTRIMAZOLE
CREAM; TOPICAL
CLOTRIMAZOLE
GLENMARK PHARMS
AB
NYCOMED US
AB
AB + TARO

1%
1%
1%

A090219 001
A078338 001
A072640 001

Aug 03, 2010

Sep 02, 2008
Aug 31, 1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 110 (of 424)

CLOTRIMAZOLE
SOLUTION; TOPICAL
CLOTRIMAZOLE
TARO
AT
TEVA
AT
MYCELEX
AT + BAYER HLTHCARE
TROCHE/LOZENGE; ORAL
CLOTRIMAZOLE
PADDOCK LLC
AB
ROXANE
AB
MYCELEX
AB + BAYER HLTHCARE

Jul 29, 1996

Feb 28, 1995

1%
1%

A074580 001
A073306 001

1%

N018181 001

10MG
10MG

A076763 001
A076387 001

Oct 28, 2005

Jul 29, 2004

10MG

N018713 001

Jun 17, 1983

25MG
50MG
100MG
25MG
50MG
50MG
100MG
100MG
25MG
100MG

A075713
A075713
A075713
A074949
A074949
A076809
A074949
A076809
A075417
A075417

Nov
Aug
Nov
Nov
Apr
Dec
Nov
Dec
May
May

25MG
100MG

N019758 001
N019758 002

Sep 26, 1989

Sep 26, 1989

12.5MG
200MG

A074949 003
A076809 001

Jul 31, 2003

Dec 16, 2005

N021590
N021590
N021590
N021590
N021590

May
Feb
Feb
Jul
Jul

CLOZAPINE
TABLET; ORAL
CLOZAPINE
CARACO
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
AB
AB
MYLAN
AB
AB
CLOZARIL
NOVARTIS
AB
AB +
CLOZAPINE
IVAX SUB TEVA PHARMS
XX
XX

XX
XX
XX
XX
XX

TABLET, ORALLY DISINTEGRATING; ORAL

FAZACLO ODT
AZUR PHARMA INTL
12.5MG
25MG
+
100MG
150MG
200MG

001
003
002
001
004
003
002
002
001
002

004
001
002
005
006

15,
19,
15,
26,
25,
16,
26,
16,
27,
27,

30,
10,
10,
09,
09,

2002
2005
2002
1997
2005
2005
1997
2005
1999
1999

2007
2004
2004
2010
2010

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
VINTAGE
AA
10MG/5ML;5MG/5ML;6.25MG/5ML
A040660 001
PROMETH VC W/ CODEINE
AA + ACTAVIS MID ATLANTIC 10MG/5ML;5MG/5ML;6.25MG/5ML
A088764 001

Dec 07, 2006

Oct 31, 1984

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

AA
AA
AA
AA
AA
AA

SYRUP; ORAL
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
+ ACTAVIS MID ATLANTIC 10MG/5ML;6.25MG/5ML
HI TECH PHARMA
10MG/5ML;6.25MG/5ML
PHARM ASSOC
10MG/5ML;6.25MG/5ML
SUN PHARM INDS INC
10MG/5ML;6.25MG/5ML
WOCKHARDT
10MG/5ML;6.25MG/5ML
PROMETHAZINE WITH CODEINE
VINTAGE
10MG/5ML;6.25MG/5ML

A088763
A040151
A089647
A090180
A088875

001
001
001
001
001

A040650 001

Oct
Aug
Dec
Mar
Dec

31,
26,
22,
17,
17,

1984
1997
1988
2010
1984

Jan 31, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 111 (of 424)

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

SYRUP; ORAL

TRIACIN-C

XX + STI PHARMA LLC

10MG/5ML;30MG/5ML;1.25MG/5ML

A088704 001

Mar 22, 1985

SOLUTION; ORAL

CODEINE SULFATE

XX + ROXANE

30MG/5ML

N202245 001

Jun 30, 2011

TABLET; ORAL
CODEINE SULFATE
ROXANE
XX
XX
XX +

15MG
30MG
60MG

N022402 001
N022402 002
N022402 003

Jul 16, 2009

Jul 16, 2009
Jul 16, 2009

0.6MG

N022352 001

Jul 29, 2009

CODEINE SULFATE

COLCHICINE
TABLET; ORAL

COLCRYS

XX + AR HOLDING CO INC

COLCHICINE; PROBENECID
TABLET; ORAL
COL-PROBENECID
AB + WATSON LABS
0.5MG;500MG
PROBENECID AND COLCHICINE
MIRROR PHARMS
0.5MG;500MG
AB

A084279 001
A040618 001

May 13, 2008

COLESEVELAM HYDROCHLORIDE
FOR SUSPENSION; ORAL

WELCHOL

DAIICHI SANKYO

XX
XX +

1.875GM/PACKET
3.75GM/PACKET

N022362 001
N022362 002

Oct 02, 2009

Oct 02, 2009

TABLET; ORAL

WELCHOL

XX + DAIICHI SANKYO

625MG

N021176 001

May 26, 2000

N017563 003
N017563 004

Sep 22, 1995

Sep 22, 1995

A077277 002
A077277 001

May 02, 2006

May 02, 2006

COLESTIPOL HYDROCHLORIDE

AB
AB
AB
AB
XX
XX

GRANULE; ORAL
COLESTID
PHARMACIA AND UPJOHN 5GM/SCOOPFUL
5GM/PACKET
+
COLESTIPOL HYDROCHLORIDE
IMPAX LABS
5GM/PACKET
5GM/SCOOPFUL
FLAVORED COLESTID

PHARMACIA AND UPJOHN 5GM/PACKET

5GM/SCOOPFUL

TABLET; ORAL
COLESTID
AB + PHARMACIA AND UPJOHN 1GM
COLESTIPOL HYDROCHLORIDE
IMPAX LABS
1GM
AB

N017563 001

N017563 002

N020222 001

Jul 19, 1994

A077510 001

Oct 24, 2006

A065364 001
A065177 001
A064216 001

Apr 17, 2008

Mar 19, 2004
Feb 26, 1999

COLISTIMETHATE SODIUM
INJECTABLE; INJECTION
COLISTIMETHATE SODIUM
APP PHARMS
AP
PADDOCK LLC
AP
X GEN PHARMS
AP

EQ 150MG BASE/VIAL
EQ 150MG BASE/VIAL
EQ 150MG BASE/VIAL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 112 (of 424)

COLISTIMETHATE SODIUM
INJECTABLE; INJECTION
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

XX + JHP PHARMS

EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG

BASE/ML;0.5MG/ML

N050356 001

CONIVAPTAN HYDROCHLORIDE
INJECTABLE; IV (INFUSION)
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER
XX + ASTELLAS
20MG/100ML (0.2MG/ML)

N021697 002

Oct 08, 2008

N018680 001

Nov 15, 1984

EQ 0.1MG BASE/VIAL

N020162 001

May 23, 1996

80 UNITS/ML

N008372 008

25MG

A080776 002

0.25MG/VIAL

N016750 001

0.25MG/VIAL

A090574 001

Dec 17, 2009

0.25MG/ML (0.25MG/ML)

N022028 001

Feb 21, 2008

200MG
250MG

N202570 001
N202570 002

Aug 26, 2011

Aug 26, 2011

N018887 001

Dec 05, 1985

COPPER
INTRAUTERINE DEVICE; INTRAUTERINE

PARAGARD T 380A

309MG/COPPER
XX + DURAMED RES

CORTICORELIN OVINE TRIFLUTATE

INJECTABLE; INJECTION

ACTHREL

XX + FERRING

CORTICOTROPIN
INJECTABLE; INJECTION
H.P. ACTHAR GEL
XX + QUESTCOR PHARMS

CORTISONE ACETATE
TABLET; ORAL

CORTISONE ACETATE

XX + WEST WARD

COSYNTROPIN
INJECTABLE; INJECTION
CORTROSYN
AP + AMPHASTAR PHARMS INC
COSYNTROPIN
BIONICHE PHARMA
AP
SOLUTION; INTRAVENOUS
COSYNTROPIN
SANDOZ
XX

CRIZOTINIB
CAPSULE; ORAL
XALKORI
PFIZER
XX
XX +

CROMOLYN SODIUM
AEROSOL, METERED; INHALATION
INTAL
XX + KING PHARMS
0.8MG/INH

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 113 (of 424)

CROMOLYN SODIUM
CONCENTRATE; ORAL
CROMOLYN SODIUM
PACK PHARMS LLC
AA
GASTROCROM
AA + AZUR PHARMA

AN
AN
AN
AN
AN
AN

AT
AT
AT
AT
AT

SOLUTION; INHALATION
CROMOLYN SODIUM
BAUSCH AND LOMB
DEY
NOVEX
+ TEVA PARENTERAL
WATSON LABS
WOCKHARDT

100MG/5ML

A202583 001

Oct 27, 2011

100MG/5ML

N020479 001

Feb 29, 1996

10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML

A075585
A074209
A075333
A075271
A076469
A075346

Dec
Apr
Apr
Jan
Jun
Oct

SOLUTION/DROPS; OPHTHALMIC
CROLOM
BAUSCH AND LOMB
4%
CROMOLYN SODIUM
AKORN
4%
ALCON
4%
NOVEX
4%
OPTICROM
+ ALLERGAN
4%

001
001
001
001
001
001

21,
26,
30,
18,
17,
25,

2000
1994
2002
2000
2005
1999

A074443 001

Jan 30, 1995

A074706 001
A075282 001
A075615 001

Apr 29, 1998

Jun 16, 1999
Jan 26, 2001

N018155 001

Oct 03, 1984

CROTAMITON
CREAM; TOPICAL

EURAX

XX + RANBAXY
LOTION; TOPICAL
CROTAN
SUMMERS
AT
EURAX
AT + RANBAXY

10%

N006927 001

10%

A087204 001

10%

N009112 003

CUPRIC CHLORIDE
INJECTABLE; INJECTION

CUPRIC CHLORIDE IN PLASTIC CONTAINER

EQ 0.4MG COPPER/ML
XX + HOSPIRA

N018960 001

Jun 26, 1986

CYANOCOBALAMIN
INJECTABLE; INJECTION
CYANOCOBALAMIN
AP + LUITPOLD
VIBISONE
AP + APP PHARMS
SPRAY, METERED; NASAL

NASCOBAL

XX + PAR PHARM

1MG/ML

A080737 001

1MG/ML

A080557 003

0.5MG/SPRAY

N021642 001

Jan 31, 2005

N021777 001
N021777 002

Feb 01, 2007

Feb 01, 2007

A090738 001
A090738 002

Apr 18, 2011

Apr 18, 2011

CYCLOBENZAPRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
AMRIX
ANESTA AG
AB
15MG
AB +
30MG
CYCLOBENZAPRINE HYDROCHLORIDE
MYLAN
AB
15MG
AB
30MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 114 (of 424)

CYCLOBENZAPRINE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
AUROBINDO PHARMA
5MG
10MG
INVAGEN PHARMS
5MG
10MG
JUBILANT CADISTA
5MG
10MG
KVK TECH
5MG
10MG
MUTUAL PHARM
5MG
10MG
MYLAN
5MG
10MG
ORIT LABS LLC
10MG
PLIVA
10MG
PROSAM LABS
5MG
10MG
RANBAXY
5MG
7.5MG
10MG
SANDOZ
5MG
10MG
VINTAGE PHARMS
5MG
10MG
WATSON LABS
5MG
7.5MG
10MG
FLEXERIL
JANSSEN R AND D
5MG
+
10MG

A078643
A078643
A090478
A090478
A077563
A077563
A078048
A078048
A073541
A073541
A073144
A073144
A078218
A074421
A077291
A077209
A078722
A078722
A078722
A072854
A072854
A077797
A077797
A071611
A071611
A071611

001
002
001
002
001
002
001
002
002
001
002
001
001
001
001
001
001
002
003
002
001
001
002
002
003
001

Sep
Sep
Jul
Jul
Apr
Apr
Feb
Feb
Apr
May
Feb
May
Apr
Sep
Feb
Oct
May
May
May
Feb
Nov
Feb
Feb
Feb
Feb
May

26,
26,
23,
23,
19,
19,
28,
28,
06,
23,
03,
30,
18,
29,
03,
04,
12,
12,
12,
03,
19,
28,
28,
03,
03,
03,

2008
2008
2010
2010
2006
2006
2011
2011
2006
1995
2006
1991
2008
1995
2006
2005
2008
2008
2008
2006
1991
2007
2007
2006
2006
1989

N017821 001
N017821 002

CYCLOPENTOLATE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
AKPENTOLATE
AKORN
AT
1%
AT
2%
CYCLOGYL
AT + ALCON
1%
AT +
2%
PENTOLAIR
BAUSCH AND LOMB
1%
AT
CYCLOGYL
0.5%
XX + ALCON

A040164 001
A040165 001

Jan 13, 1997

Jan 13, 1997

A084110 001
A084108 001
A040075 001

Apr 29, 1994

A084109 001

CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

SOLUTION/DROPS; OPHTHALMIC

CYCLOMYDRIL

0.2%;1%
XX + ALCON

A084300 001

CYCLOPHOSPHAMIDE

AP
AP
AP
AP
AP

INJECTABLE; INJECTION
CYCLOPHOSPHAMIDE
+ BAXTER HLTHCARE
+
+
CYTOXAN
BAXTER HLTHCARE

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

A040745 001
A040745 002
A040745 003

May 21, 2008

May 21, 2008
May 21, 2008

500MG/VIAL
1GM/VIAL

N012142 003
N012142 004

Aug 30, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 115 (of 424)

CYCLOPHOSPHAMIDE
INJECTABLE; INJECTION
CYTOXAN
BAXTER HLTHCARE
AP

2GM/VIAL

N012142 005

Aug 30, 1982

TABLET; ORAL
CYCLOPHOSPHAMIDE
ROXANE
XX
XX +

25MG
50MG

A040032 001
A040032 002

Aug 17, 1999

Aug 17, 1999

250MG

A060593 001

25MG
50MG
100MG
25MG
100MG
25MG
100MG

A065110
A065110
A065110
A065044
A065044
A065017
A065017

25MG
50MG
100MG

A065003 001
A065003 002
A065003 003

May 12, 2000

May 12, 2000
May 12, 2000

25MG
100MG

N050715 001
N050715 002

Jul 14, 1995

Jul 14, 1995

25MG
100MG

A065040 001
A065040 002

May 09, 2002

May 09, 2002

25MG
100MG

N050625 001
N050625 002

Mar 02, 1990

Mar 02, 1990

50MG

N050625 003

Nov 23, 1992

0.05%

N050790 001

Dec 23, 2002

50MG/ML
50MG/ML

A065004 001
A065151 001

Oct 29, 1999

Oct 07, 2003

50MG/ML

N050573 001

Nov 14, 1983

100MG/ML
100MG/ML
100MG/ML
100MG/ML

A065025
A065078
A065167
A065054

Mar
Mar
Jan
Dec

100MG/ML

N050716 001

Jul 14, 1995

100MG/ML

A065133 001

Sep 17, 2004

CYCLOSERINE
CAPSULE; ORAL

SEROMYCIN

XX + PURDUE GMP

CYCLOSPORINE
CAPSULE; ORAL
CYCLOSPORINE
IVAX SUB TEVA PHARMS
AB1
AB1
AB1
PLIVA
AB1
AB1
SANDOZ
AB1
AB1
GENGRAF
ABBOTT
AB1
AB1
AB1
NEORAL
NOVARTIS
AB1
AB1 +
CYCLOSPORINE
APOTEX
AB2
AB2
SANDIMMUNE
NOVARTIS
AB2
AB2 +
SANDIMMUNE
BX
NOVARTIS
EMULSION; OPHTHALMIC

RESTASIS

XX + ALLERGAN
INJECTABLE; INJECTION
CYCLOSPORINE
BEDFORD
AP
LUITPOLD
AP
SANDIMMUNE
AP + NOVARTIS
SOLUTION; ORAL
CYCLOSPORINE
ABBOTT
AB1
IVAX SUB TEVA PHARMS
AB1
NOVEX
AB1
WATSON LABS
AB1
NEORAL
AB1 + NOVARTIS
CYCLOSPORINE
WOCKHARDT
AB2

003
001
002
002
001
002
001

001
001
001
001

Mar
Mar
Mar
Dec
Dec
Jan
Jan

29,
29,
29,
20,
20,
13,
13,

03,
25,
05,
18,

2005
2005
2005
2000
2000
2000
2000

2000
2005
2005
2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 116 (of 424)

CYCLOSPORINE
SOLUTION; ORAL
SANDIMMUNE
AB2 + NOVARTIS

N050574 001

Nov 14, 1983

A040668 001

Jun 28, 2006

A040537
A087056
A087129
A040644

001
001
001
001

Sep 30, 2003

EQ 50MG BASE
EQ 150MG BASE

N020392 001
N020392 002

Aug 15, 1994

Aug 15, 1994

100MG/ML
100MG/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL
20MG/ML
20MG/ML
20MG/ML
100MG/ML
20MG/ML
20MG/ML
20MG/ML

A076512
A071471
A071472
A074245
A074245
A071868
A072168
A072945
A075383
A200914
A200915
A200916

001
001
001
001
002
001
001
001
001
001
001
001

Jan
Aug
Aug
Aug
Aug
Jun
Aug
Feb
Nov
Dec
Dec
Dec

15,
02,
02,
31,
31,
04,
31,
28,
22,
13,
13,
13,

2004
1989
1989
1994
1994
1990
1990
1994
1999
2011
2011
2011

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

A075206
A075206
A075206
A075206

001
002
004
003

Dec
Dec
Dec
Dec

30,
30,
30,
30,

1998
1998
1998
1998

100MG/ML

CYPROHEPTADINE HYDROCHLORIDE
SYRUP; ORAL
CYPROHEPTADINE HYDROCHLORIDE
AA + LYNE
2MG/5ML

AA
AA
AA
AA

TABLET; ORAL
CYPROHEPTADINE HYDROCHLORIDE
COREPHARMA
4MG
+ IVAX SUB TEVA PHARMS 4MG
PAR PHARM
4MG
STASON PHARMS
4MG

May 30, 2006

CYSTEAMINE BITARTRATE
CAPSULE; ORAL
CYSTAGON
MYLAN
XX
XX +

CYTARABINE
INJECTABLE; INJECTION
CYTARABINE
AP + APP PHARMS
BEDFORD
AP
AP
AP
AP
AP + HOSPIRA
AP +
AP +
AP
ONCO THERAPIES LTD
AP
AP
AP
CYTOSAR-U
TEVA PARENTERAL
AP
AP +
AP +
AP +

INJECTABLE, LIPOSOMAL; INJECTION

DEPOCYT

10MG/ML
XX + PACIRA PHARMS INC

N021041 001

Apr 01, 1999

75MG
150MG

N022512 001
N022512 002

Oct 18, 2010

Oct 18, 2010

100MG/VIAL
200MG/VIAL
200MG/VIAL
500MG/VIAL

A075371
A075371
A075812
A075812

Aug
Aug
Jun
Oct

DABIGATRAN ETEXILATE MESYLATE

CAPSULE; ORAL
PRADAXA
BOEHRINGER INGELHEIM
XX
XX +

DACARBAZINE
INJECTABLE; INJECTION
DACARBAZINE
APP PHARMS
AP
AP
BEDFORD
AP
AP

001
002
001
002

27,
27,
15,
31,

1999
1999
2001
2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 117 (of 424)

DACARBAZINE

AP
AP
AP
AP
AP

INJECTABLE; INJECTION
DACARBAZINE
HOSPIRA
TEVA PARENTERAL
+
DTIC-DOME
+ BAYER HLTHCARE
+

Oct 18, 2001

Aug 27, 1998
Sep 22, 2000

200MG/VIAL
200MG/VIAL
500MG/VIAL

A075940 001
A075259 002
A075259 001

100MG/VIAL
200MG/VIAL

N017575 001
N017575 002

0.5MG/VIAL

N050682 001

0.5MG/VIAL

A090304 001

Mar 16, 2010

N022250 001

Jan 22, 2010

N050748 001

Sep 21, 1999

2,500IU/0.2ML (12,500IU/ML)
5,000IU/0.2ML (25,000IU/ML)
7,500IU/0.3ML (25,000IU/ML)
10,000IU/ML (10,000IU/ML)
10,000IU/0.4ML (25,000IU/ML)
12,500IU/0.5ML (25,000IU/ML)
15,000IU/0.6ML (25,000IU/ML)
18,000IU/0.72ML (25,000IU/ML)
95,000IU/3.8ML (25,000IU/ML)
95,000IU/9.5ML (10,000IU/ML)

N020287
N020287
N020287
N020287
N020287
N020287
N020287
N020287
N020287
N020287

001
003
005
004
002
009
010
011
006
007

Dec
Mar
Apr
Jan
May
May
May
May
Apr
Apr

22,
18,
04,
30,
01,
01,
01,
01,
04,
04,

1994
1996
2002
1998
2007
2007
2007
2007
2002
2002

50MG
100MG
200MG
50MG
100MG
200MG

A074582
A074582
A074582
A078214
A078214
A077246

003
002
001
001
002
001

May
May
Aug
Apr
Apr
Sep

29,
29,
09,
19,
19,
28,

1998
1998
1996
2007
2007
2005

25MG
50MG
100MG

N017443 001
N017443 003
N017443 002

25MG

A076856 001

DACTINOMYCIN
INJECTABLE; INJECTION
COSMEGEN
AP + LUNDBECK INC
DACTINOMYCIN
BEDFORD
AP

DALFAMPRIDINE
TABLET, EXTENDED RELEASE; ORAL

AMPYRA

XX + ACORDA
10MG

DALFOPRISTIN; QUINUPRISTIN
INJECTABLE; IV (INFUSION)

SYNERCID

350MG/VIAL;150MG/VIAL
XX + KING PHARMS

DALTEPARIN SODIUM
INJECTABLE; SUBCUTANEOUS
FRAGMIN
EISAI INC
XX
XX
XX
XX
XX
XX
XX
XX
XX +
XX

DANAZOL
CAPSULE; ORAL
DANAZOL
BARR
AB
AB
AB +
LANNETT
AB
AB
AB

DANTROLENE SODIUM
CAPSULE; ORAL
DANTRIUM
JHP PHARMS
AB
AB
AB +
DANTROLENE SODIUM
IMPAX LABS
AB

Mar 01, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 118 (of 424)

DANTROLENE SODIUM
CAPSULE; ORAL
DANTROLENE SODIUM
IMPAX LABS
AB
AB

Mar 01, 2005

Mar 01, 2005

50MG
100MG

A076856 002
A076856 003

20MG/VIAL

N018264 001

20MG/VIAL

A078378 001

Jul 24, 2007

GEL; TOPICAL

ACZONE

XX + ALLERGAN

5%

N021794 001

Jul 07, 2005

TABLET; ORAL

DAPSONE

JACOBUS
XX
XX +

25MG

100MG

A086841 001

A086842 001

INJECTABLE; INJECTION
DANTRIUM
AP + JHP PHARMS
DANTROLENE SODIUM
US WORLDMEDS
AP

DAPSONE

DAPTOMYCIN
INJECTABLE; IV (INFUSION)

CUBICIN

XX + CUBIST
500MG/VIAL

N021572 002

Sep 12, 2003

N021513 001
N021513 002

Dec 22, 2004

Dec 22, 2004

DARIFENACIN HYDROBROMIDE
TABLET, EXTENDED RELEASE; ORAL
ENABLEX
XX
WARNER CHILCOTT LLC
EQ 7.5MG BASE
XX +
EQ 15MG BASE

DARUNAVIR ETHANOLATE
SUSPENSION; ORAL

PREZISTA

XX + TIBOTEC

EQ 100MG BASE/ML

N202895 001

Dec 16, 2011

TABLET; ORAL
PREZISTA
TIBOTEC
XX
XX
XX
XX +

EQ
EQ
EQ
EQ

N021976
N021976
N021976
N021976

004
005
003
002

Dec
Dec
Oct
Feb

18,
18,
21,
25,

2008
2008
2008
2008

N021986
N021986
N021986
N021986
N021986
N021986

001
002
003
005
004
006

Jun
Jun
Jun
Oct
May
Oct

28,
28,
28,
28,
30,
28,

2006
2006
2006
2010
2008
2010

75MG BASE
150MG BASE
400MG BASE
600MG BASE

DASATINIB
TABLET; ORAL

SPRYCEL

BRISTOL MYERS SQUIBB

XX
XX
XX
XX
XX
XX +

20MG

50MG

70MG

80MG

100MG

140MG

DAUNORUBICIN CITRATE
INJECTABLE, LIPOSOMAL; INJECTION

DAUNOXOME

EQ 2MG BASE/ML
XX + GALEN (UK)

N050704 002

Apr 08, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 119 (of 424)

DAUNORUBICIN HYDROCHLORIDE

AP
AP
AP
AP
XX

INJECTABLE; INJECTION
CERUBIDINE
+ BEDFORD
EQ
DAUNORUBICIN HYDROCHLORIDE
APP PHARMS
EQ
+ BEDFORD
EQ
TEVA PARENTERAL
EQ
DAUNORUBICIN HYDROCHLORIDE
APP PHARMS
EQ

20MG BASE/VIAL

A064103 001

Feb 03, 1995

20MG BASE/VIAL
5MG BASE/ML
5MG BASE/ML

A065000 001
N050731 001
A065035 001

May 25, 1999

Jan 30, 1998
Jan 24, 2000

5MG BASE/VIAL

A065034 001

Nov 20, 2001

N021790 001

May 02, 2006

N021882 001
N021882 002
N021882 003

Nov 02, 2005

Nov 02, 2005
Nov 02, 2005

500MG

N021825 001

Oct 14, 2011

500MG/VIAL
2GM/VIAL
500MG/VIAL
2GM/VIAL
500MG/VIAL
2GM/VIAL
500MG/VIAL
2GM/VIAL

A078718
A078718
A078086
A078086
A076019
A076019
A076806
A076806

Sep
Sep
May
May
Mar
Mar
Mar
Mar

500MG/VIAL
2GM/VIAL

N016267 001
N016267 002

May 25, 2000

EQ 80MG BASE/VIAL
EQ 120MG BASE/VIAL

N022201 001
N022201 002

Dec 24, 2008

Dec 24, 2008

100MG
200MG

N020705 001
N020705 002

Apr 04, 1997

Jul 14, 1999

DECITABINE
INJECTABLE; INTRAVENOUS

DACOGEN

XX + EISAI INC

50MG/VIAL

DEFERASIROX
TABLET, FOR SUSPENSION; ORAL
EXJADE
NOVARTIS
125MG
XX
250MG
XX
500MG
XX +

DEFERIPRONE
TABLET; ORAL

FERRIPROX

XX + APOPHARMA INC

DEFEROXAMINE MESYLATE
INJECTABLE; INJECTION
DEFEROXAMINE MESYLATE
APP PHARMS
AP
AP
BEDFORD
AP
AP
HOSPIRA
AP
AP
WATSON LABS
AP
AP
DESFERAL
AP + NOVARTIS
AP +

001
002
001
002
001
002
001
002

15,
15,
30,
30,
17,
17,
31,
31,

2009
2009
2007
2007
2004
2004
2006
2006

DEGARELIX ACETATE
POWDER; SUBCUTANEOUS
FIRMAGON
FERRING
XX
XX +

DELAVIRDINE MESYLATE
TABLET; ORAL
RESCRIPTOR
VIIV HLTHCARE
XX
XX +

DEMECLOCYCLINE HYDROCHLORIDE
TABLET; ORAL
DECLOMYCIN
COREPHARMA
AB

150MG

N050261 002

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PRESCRIPTION DRUG PRODUCT LIST

3 - 120 (of 424)

DEMECLOCYCLINE HYDROCHLORIDE
TABLET; ORAL
DECLOMYCIN
AB + COREPHARMA
300MG
DEMECLOCYCLINE HYDROCHLORIDE
AMNEAL PHARM
150MG
AB
300MG
AB
BARR
150MG
AB
300MG
AB
IMPAX LABS
150MG
AB
300MG
AB
VERSAPHARM
150MG
AB
300MG
AB

N050261 003
A065425
A065425
A065171
A065171
A065094
A065094
A065389
A065389

001
002
001
002
001
002
001
002

Feb
Feb
Dec
Dec
Mar
Mar
Dec
Dec

27,
27,
13,
13,
22,
22,
01,
01,

2008
2008
2004
2004
2004
2004
2008
2008

DESFLURANE
LIQUID; INHALATION

SUPRANE

XX + BAXTER HLTHCARE CORP

99.9%

N020118 001

Sep 18, 1992

A074430
A071601
A071588
A071602
A071766
A074430
A072099
A072100
A072101
A072102
A072103
A072104

001
001
001
001
001
002
001
001
001
001
001
001

Feb
Jun
Jun
Oct
Oct
Feb
May
May
May
Jun
Jun
Jun

N014399
N014399
N014399
N014399
N014399
N014399

007
001
003
004
005
006

Feb 11, 1982

15MG/VIAL

N021271 001

Apr 04, 2003

0.5MG/ML

N021300 001

Sep 01, 2004

5MG

N021165 001

Dec 21, 2001

5MG
5MG
5MG
5MG

A078365
A078352
A078357
A078361

Mar
Oct
Feb
Dec

DESIPRAMINE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
DESIPRAMINE HYDROCHLORIDE
ACTAVIS TOTOWA
10MG
25MG
50MG
75MG
100MG
150MG
SANDOZ
10MG
25MG
50MG
75MG
100MG
150MG
NORPRAMIN
SANOFI AVENTIS US
10MG
25MG
+
50MG
75MG
+
100MG
150MG

09,
05,
05,
05,
05,
09,
24,
24,
24,
20,
20,
20,

1996
1987
1987
1987
1987
1996
1988
1988
1988
1988
1988
1988

DESIRUDIN RECOMBINANT
INJECTABLE; SUBCUTANEOUS

IPRIVASK

XX + CANYON

DESLORATADINE
SYRUP; ORAL

CLARINEX

XX + SCHERING

AB
AB
AB
AB
AB

TABLET; ORAL
CLARINEX
+ SCHERING PLOUGH
DESLORATADINE
DR REDDYS LABS LTD
LUPIN PHARMS
ORCHID HLTHCARE
PERRIGO R AND D

001
001
001
001

08,
25,
19,
22,

2011
2010
2010
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 121 (of 424)

DESLORATADINE
TABLET; ORAL
DESLORATADINE
SANDOZ
AB
SUN PHARM INDS
AB

AB
AB
AB
AB

A078364 001
A078359 001

Dec 03, 2010

Nov 16, 2010

N021312 002
N021312 001

Jul 14, 2005

Jun 26, 2002

A078367 001
A078367 002

Jul 12, 2010

Jul 12, 2010

N021605 001

Mar 03, 2005

A078366 001

Apr 26, 2011

N021313 001

Feb 01, 2006

0.004MG/ML

N018938 001

Mar 30, 1984

0.004MG/ML
0.004MG/ML

A075220 001
A074888 001

Aug 28, 2000

Oct 15, 1997

0.01%

N017922 001

5MG
5MG

TABLET, ORALLY DISINTEGRATING; ORAL

CLARINEX
SCHERING
2.5MG
+
5MG
DESLORATADINE
REDDYS
2.5MG
5MG

DESLORATADINE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE; ORAL
CLARINEX D 24 HOUR
AB + SCHERING
5MG;240MG
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR
DR REDDYS LABS LTD
AB
5MG;240MG
CLARINEX-D 12 HOUR
XX + SCHERING
2.5MG;120MG

DESMOPRESSIN ACETATE
INJECTABLE; INJECTION
DDAVP
AP + SANOFI AVENTIS US
DESMOPRESSIN ACETATE
HOSPIRA
AP
TEVA PARENTERAL
AP
SOLUTION; NASAL

DDAVP

XX + SANOFI AVENTIS US

AB
AB
AB
AB
XX

SPRAY, METERED; NASAL

DDAVP (NEEDS NO REFRIGERATION)
+ SANOFI AVENTIS US
0.01MG/SPRAY
DESMOPRESSIN ACETATE
+ BAUSCH AND LOMB
0.01MG/SPRAY
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
APOTEX INC
0.01MG/SPRAY
MINIRIN
+ FERRING
0.01MG/SPRAY
STIMATE (NEEDS NO REFRIGERATION)
+ CSL BEHRING
1.5MG/SPRAY

TABLET; ORAL
DDAVP
SANOFI AVENTIS US
AB
AB +
DESMOPRESSIN ACETATE
APOTEX INC
AB
AB
TEVA PHARMS
AB
AB
WATSON LABS
AB
AB
DESMOPRESSIN ACETATE
FERRING
XX
XX +

N017922 003

Aug 07, 1996

A074830 001

Jan 25, 1999

A076703 001

Jan 27, 2005

N021333 001

Sep 16, 2002

N020355 002

Oct 24, 2007

0.1MG
0.2MG

N019955 001
N019955 002

Sep 06, 1995

Sep 06, 1995

0.1MG
0.2MG
0.1MG
0.2MG
0.1MG
0.2MG

A077414
A077414
A077122
A077122
A076470
A076470

Mar
Mar
Jan
Jan
Jul
Jul

0.1MG
0.2MG

N021795 001
N021795 002

001
002
001
002
001
002

07,
07,
25,
25,
01,
01,

2006
2006
2006
2006
2005
2005

May 08, 2008

May 08, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 122 (of 424)

DESOGESTREL; ETHINYL ESTRADIOL

TABLET; ORAL-28
CYCLESSA
AB + ORGANON USA INC

0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.
025MG

N021090 001

Dec 20, 2000

0.15MG;0.03MG
ESTRADIOL
0.15MG;0.03MG
0.15MG,N/A;0.02MG,0.01MG
0.15MG;0.03MG

N020071 002

Dec 10, 1992

A075256 002
A076916 001
A076915 001

Aug 12, 1999

Dec 29, 2008
Jul 29, 2005

0.15MG;0.03MG

A076675 001

Feb 25, 2011

0.15MG,N/A;0.02MG,0.01MG

A075863 001

Apr 05, 2002

0.15MG,N/A;0.02MG,0.01MG

N020713 001

Apr 22, 1998

0.15MG;0.03MG

N020301 002

Dec 14, 1992

0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.
025MG

A076455 001

Feb 24, 2004

0.05%

N021978 001

Sep 19, 2006

0.05%
0.05%

N017010 001
A073548 001

Jun 30, 1992

0.05%

N019048 001

Dec 14, 1984

0.05%

N021844 001

Oct 20, 2006

LOTION; TOPICAL
DESONIDE
ALTANA
AB
DESOWEN
AB + GALDERMA LABS LP

0.05%

A075860 001

Mar 19, 2002

0.05%

A072354 001

Jan 24, 1992

OINTMENT; TOPICAL
DESONIDE
ALTANA
+ PERRIGO NEW YORK
TARO
DESOWEN
GALDERMA LABS LP

0.05%
0.05%
0.05%

A075751 001
N017426 001
A074254 001

Mar 12, 2001

0.05%

A071425 001

Jun 15, 1988

0.25%
0.25%
0.05%
0.25%

A078369
A076510
A073210
A073193

Jun
Jul
Nov
Nov

0.25%

N017856 001

0.05%

N018309 001

AB
AB
AB
AB
AB
AB
AB
AB
AB

DESOGEN
ORGANON USA INC
DESOGESTREL AND ETHINYL
DURAMED PHARMS BARR
WATSON LABS
EMOQUETTE
VINTAGE
KARIVA
BARR
MIRCETTE
+ TEVA WOMENS
ORTHO-CEPT
+ JANSSEN PHARMS
VELIVET
DURAMED PHARMS BARR

DESONIDE
AEROSOL, FOAM; TOPICAL

VERDESO

XX + STIEFEL LABS INC

CREAM; TOPICAL
DESONIDE
AB + PERRIGO NEW YORK
TARO
AB
DESOWEN
GALDERMA LABS LP
AB
GEL; TOPICAL

DESONATE

XX + INTENDIS

AB
AB
AB
AB

Aug 03, 1994

DESOXIMETASONE
CREAM; TOPICAL
DESOXIMETASONE
NYCOMED US
AB
PERRIGO NEW YORK
AB
AB + TARO
AB
TOPICORT
AB + TARO PHARMS NORTH
TOPICORT LP
TARO PHARMS NORTH
AB

001
001
001
001

29,
01,
30,
30,

2010
2003
1990
1990

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 123 (of 424)

DESOXIMETASONE
GEL; TOPICAL
DESOXIMETASONE
PERRIGO NEW YORK
TARO
VERSAPHARM
TOPICORT
+ TARO PHARMS NORTH

0.05%
0.05%
0.05%

A077552 001
A074904 001
A090727 001

Jan 09, 2006

Jul 14, 1998
Mar 10, 2011

0.05%

N018586 001

Mar 29, 1982

0.25%

A074286 001

Jun 07, 1996

0.25%

N018763 001

Sep 30, 1983

0.05%

N018594 001

Jan 17, 1985

N021992 001
N021992 002

Feb 29, 2008

Feb 29, 2008

A088252 001

Sep 01, 1983

0.5MG/5ML
0.5MG/5ML
0.5MG/5ML
0.5MG/5ML

A090891
A084754
A091188
A088254

001
001
001
001

Jul 12, 2011

IMPLANT; INTRAVITREAL

OZURDEX

XX + ALLERGAN

0.7MG

N022315 001

Jun 17, 2009

SOLUTION; ORAL

DEXAMETHASONE

XX + ROXANE

0.5MG/5ML

A088248 001

Sep 01, 1983

AB
AB
AB
AB

OINTMENT; TOPICAL
DESOXIMETASONE
TARO
AB
TOPICORT
AB + TARO PHARMS NORTH
TOPICORT
XX + TARO PHARMS NORTH

DESVENLAFAXINE SUCCINATE
TABLET, EXTENDED RELEASE; ORAL

PRISTIQ

EQ 50MG BASE
XX + WYETH PHARMS INC
EQ 100MG BASE
XX +

DEXAMETHASONE
CONCENTRATE; ORAL

DEXAMETHASONE INTENSOL

1MG/ML
XX + ROXANE

AA
AA
AA
AA

ELIXIR; ORAL
DEXAMETHASONE
LYNE
+ STI PHARMA LLC
VINTAGE PHARMS
+ WOCKHARDT

SUSPENSION/DROPS; OPHTHALMIC

MAXIDEX

XX + ALCON
0.1%
TABLET; ORAL
DEXAMETHASONE
ECR
AB
ROXANE
AB
DEXAMETHASONE
BP
PAR PHARM
BP
BP
BP
BP +
BP
ROXANE
BP
BP
BP
BP
BP +

May 11, 2011

Jul 27, 1983

N013422 001

1.5MG
1.5MG

A040700 001
A084610 001

Aug 15, 2008

0.5MG
0.75MG
1.5MG
4MG
6MG
0.5MG
0.75MG
1MG
2MG
4MG
6MG

A088148
A088160
A088237
A088238
A088481
A084611
A084613
A088306
A087916
A084612
A088316

Apr
Apr
Apr
Apr
Nov

001
001
001
001
001
001
001
001
001
001
001

28,
28,
28,
28,
28,

1983
1983
1983
1983
1983

Sep 15, 1983

Aug 26, 1982
Sep 15, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 124 (of 424)

DEXAMETHASONE SODIUM PHOSPHATE

INJECTABLE; INJECTION
DEXAMETHASONE SODIUM PHOSPHATE
APP PHARMS
AP
EQ 4MG PHOSPHATE/ML
AP
EQ 10MG PHOSPHATE/ML
AP
EQ 10MG PHOSPHATE/ML
AP + BAXTER HLTHCARE
EQ 10MG PHOSPHATE/ML
AP + LUITPOLD
EQ 4MG PHOSPHATE/ML
PFIZER
AP
EQ 4MG PHOSPHATE/ML
AP
EQ 10MG PHOSPHATE/ML

A084916
A040491
A040572
A087702
A087440
A040803
A040802

SOLUTION/DROPS; OPHTHALMIC, OTIC

DEXAMETHASONE SODIUM PHOSPHATE
AT + ALCON UNIVERSAL
EQ 0.1% PHOSPHATE
BAUSCH AND LOMB
AT
EQ 0.1% PHOSPHATE

A088771 001
A040069 001

001
001
001
001
001
001
001

Apr
Apr
Sep
Jul
Aug
Aug

11,
22,
07,
21,
29,
29,

2003
2005
1982
1982
2008
2008

Jan 16, 1985

Jul 26, 1996

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC
MAXITROL
AT + FALCON PHARMS
0.1%;EQ 3.5MG
NEOMYCIN AND POLYMYXIN B SULFATES AND
BAUSCH AND LOMB
AT
0.1%;EQ 3.5MG
FERA PHARMS
AT
0.1%;EQ 3.5MG

AT
AT
AT
AT

SUSPENSION/DROPS; OPHTHALMIC
DEXASPORIN
BAUSCH AND LOMB
0.1%;EQ 3.5MG
MAXITROL
ALCON
0.1%;EQ 3.5MG
+ FALCON PHARMS
0.1%;EQ 3.5MG
NEOMYCIN AND POLYMYXIN B SULFATES AND
ALCON UNIVERSAL
0.1%;EQ 3.5MG

BASE/GM;10,000 UNITS/GM
DEXAMETHASONE
BASE/GM;10,000 UNITS/GM
BASE/GM;10,000 UNITS/GM

N050065 002
A064063 001
A062938 001

Jul 25, 1994

Jul 31, 1989

BASE/ML;10,000 UNITS/ML

A064135 001

Sep 13, 1995

BASE/ML;10,000 UNITS/ML
BASE/ML;10,000 UNITS/ML
DEXAMETHASONE
BASE/ML;10,000 UNITS/ML

A062341 001
N050023 002

May 22, 1984

A062721 001

Nov 17, 1986

N050616 001

Sep 28, 1988

N050592 001

Aug 18, 1988

A064134 001

Oct 27, 1999

N050818 001

Feb 13, 2009

A088251 001

Mar 23, 1984

N022287 001
N022287 002

Jan 30, 2009

Jan 30, 2009

N021038 001

Dec 17, 1999

DEXAMETHASONE; TOBRAMYCIN
OINTMENT; OPHTHALMIC

TOBRADEX

XX + ALCON

0.1%;0.3%

SUSPENSION/DROPS; OPHTHALMIC
TOBRADEX
AB + ALCON
0.1%;0.3%
TOBRAMYCIN AND DEXAMETHASONE
BAUSCH AND LOMB
AB
0.1%;0.3%
TOBRADEX ST
0.05%;0.3%
XX + ALCON PHARMS LTD

DEXCHLORPHENIRAMINE MALEATE
SYRUP; ORAL

DEXCHLORPHENIRAMINE MALEATE

2MG/5ML
XX + WOCKHARDT

DEXLANSOPRAZOLE
CAPSULE, DELAYED RELEASE; ORAL
DEXILANT
XX
TAKEDA PHARMS
30MG
XX +
60MG

DEXMEDETOMIDINE HYDROCHLORIDE
INJECTABLE; INJECTION

PRECEDEX

XX + HOSPIRA

EQ 100MCG BASE/ML (EQ100MCG BASE/ML)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 125 (of 424)

DEXMETHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
FOCALIN XR
NOVARTIS
5MG
XX
10MG
XX
15MG
XX
20MG
XX
25MG
XX
30MG
XX
35MG
XX
40MG
XX +

N021802
N021802
N021802
N021802
N021802
N021802
N021802
N021802

TABLET; ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDE
TEVA PHARMS
AB
2.5MG
AB
5MG
AB
10MG
FOCALIN
NOVARTIS
AB
2.5MG
AB
5MG
AB +
10MG

001
002
004
003
008
005
007
006

May
May
Aug
May
Apr
Oct
Apr
Aug

26,
26,
01,
26,
21,
23,
21,
11,

2005
2005
2006
2005
2011
2009
2011
2010

A077107 003
A077107 001
A077107 002

Jan 29, 2007

Jan 29, 2007
Jan 29, 2007

N021278 001
N021278 002
N021278 003

Nov 13, 2001

Nov 13, 2001
Nov 13, 2001

A076068
A076068
A200752
A200752

Sep
Sep
Oct
Oct

DEXRAZOXANE HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
XX

INJECTABLE; INJECTION
DEXRAZOXANE HYDROCHLORIDE
BEDFORD
EQ
EQ
MYLAN INSTITUTIONAL
EQ
EQ
ZINECARD
+ PHARMACIA AND UPJOHN EQ
+
EQ
TOTECT
+ TOPOTARGET
EQ

250MG
500MG
250MG
500MG

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

001
002
001
002

28,
28,
19,
19,

2004
2004
2011
2011

250MG BASE/VIAL
500MG BASE/VIAL

N020212 001
N020212 002

May 26, 1995

May 26, 1995

500MG BASE/VIAL

N022025 001

Sep 06, 2007

DEXTROAMPHETAMINE SULFATE
CAPSULE, EXTENDED RELEASE; ORAL
DEXEDRINE
COREPHARMA
AB
5MG
AB
10MG
AB +
15MG
DEXTROAMPHETAMINE SULFATE
BARR
5MG
AB
10MG
AB
15MG
AB
MALLINCKRODT
5MG
AB
10MG
AB
15MG
AB

A076137
A076137
A076137
A076353
A076353
A076353

SOLUTION; ORAL

DEXTROAMPHETAMINE SULFATE

5MG/5ML
XX + OUTLOOK PHARMS

A040776 001

Jan 29, 2008

TABLET; ORAL
DEXTROAMPHETAMINE SULFATE
BARR
5MG
AA
10MG
AA +
MALLINCKRODT
5MG
AA
10MG
AA
MIKART
5MG
AA
10MG
AA
NESHER PHARMS
5MG
AA

A040361
A040361
A040436
A040436
A090533
A090533
A040365

Jan
Jan
Jan
Jan
Oct
Oct
Oct

N017078 001
N017078 002
N017078 003
001
002
003
001
002
003

001
002
001
002
002
004
001

Jan
Jan
Jan
May
May
May

18,
18,
18,
06,
06,
06,

31,
31,
29,
29,
25,
25,
31,

2002
2002
2002
2003
2003
2003

2001
2001
2002
2002
2011
2011
2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 126 (of 424)

DEXTROAMPHETAMINE SULFATE
TABLET; ORAL
DEXTROAMPHETAMINE SULFATE
NESHER PHARMS
AA
10MG
DEXTROAMPHETAMINE SULFATE
MIKART
2.5MG

XX
7.5MG

XX
15MG

XX
20MG

XX
30MG

XX

A040367 001

Oct 31, 2002

A090533
A090533
A090533
A090533
A090533

Oct
Oct
Oct
Oct
Oct

001
003
005
006
007

25,
25,
25,
25,
25,

2011
2011
2011
2011
2011

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

AA
AA
AA
AA
AA

SYRUP; ORAL
PROMETH W/ DEXTROMETHORPHAN
+ ACTAVIS MID ATLANTIC 15MG/5ML;6.25MG/5ML
PROMETHAZINE DM
VINTAGE
15MG/5ML;6.25MG/5ML
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
AMNEAL PHARMS
15MG/5ML;6.25MG/5ML
HI TECH PHARMA
15MG/5ML;6.25MG/5ML
PROMETHAZINE W/ DEXTROMETHORPHAN
WOCKHARDT
15MG/5ML;6.25MG/5ML

A088762 001

Oct 31, 1984

A040649 001

Feb 14, 2006

A090575 001
A040027 001

Feb 08, 2011

Jul 31, 1996

A088864 001

Jan 04, 1985

N021879 001

Oct 29, 2010

N019626 004
N016694 001
N018080 001

Feb 02, 1988

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

CAPSULE; ORAL

NUEDEXTA

XX + AVANIR PHARMS

20MG;10MG

DEXTROSE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
DEXTROSE 10% IN PLASTIC CONTAINER
+ B BRAUN
10GM/100ML
+ BAXTER HLTHCARE
10GM/100ML
+ HOSPIRA
10GM/100ML
DEXTROSE 20% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
20GM/100ML
+ HOSPIRA
20GM/100ML
DEXTROSE 30% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
30GM/100ML
+ HOSPIRA
30GM/100ML
DEXTROSE 40% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
40GM/100ML
+ HOSPIRA
40GM/100ML
DEXTROSE 5% IN PLASTIC CONTAINER
+ B BRAUN
50MG/ML
+
5GM/100ML
+
5GM/100ML
+ BAXTER HLTHCARE
50MG/ML
+
50MG/ML
+
5GM/100ML
+
5GM/100ML
+ HOSPIRA
50MG/ML
+
50MG/ML
+
5GM/100ML
+
5GM/100ML
DEXTROSE 50% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
50GM/100ML
+
50GM/100ML
HOSPIRA
500MG/ML
+
50GM/100ML

N017521 004
N018564 001

Mar 23, 1982

N017521 003
N019345 001

Jan 26, 1985

N017521 002
N018562 001

Mar 23, 1982

N016730
N016730
N019626
N016673
N020179
N016673
N020179
N016367
N019222
N019466
N019479

002
001
002
003
002
001
001
002
001
001
001

Jul 13, 1984

Jul 15, 1985
Sep 17, 1985

N017521
N020047
N019445
N018563

001
001
001
001

Jul 02, 1991

Jun 03, 1986
Mar 23, 1982

Feb 02, 1988

Oct 30, 1985
Dec 07, 1992
Dec 07, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 127 (of 424)

DEXTROSE

AP
AP
AP
AP
AP
AP
XX

INJECTABLE; INJECTION
DEXTROSE 50% IN PLASTIC
+ HOSPIRA
DEXTROSE 60% IN PLASTIC
+ BAXTER HLTHCARE
DEXTROSE 70% IN PLASTIC
+ BAXTER HLTHCARE
+
+ HOSPIRA
+
DEXTROSE 25%
+ HOSPIRA

CONTAINER
50GM/100ML
CONTAINER
60GM/100ML
CONTAINER
70GM/100ML
70GM/100ML
70GM/100ML
70GM/100ML
250MG/ML

N019445 002

N019894 001

Dec 26, 1989

N017521 005

Mar 26, 1982

N017521
N020047
N018561
N019893

Mar
Jul
Mar
Dec

006
003
001
001

26,
02,
23,
26,

1982
1991
1982
1989

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/
XX
100ML

N017385 001

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/
XX
100ML

N017610 001

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
XX
00ML;320MG/100ML

N019873 001

Jun 10, 1993

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/
XX
100ML;180MG/100ML;280MG/100ML;16MG/100M
L

N019515 001

May 08, 1986

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
XX
00ML;12MG/100ML;260MG/100ML

N017484 001

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
XX
00ML;260MG/100ML;25MG/100ML

N019513 001

May 08, 1986

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
XX
00ML;140MG/100ML

N019844 001

Jun 10, 1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 128 (of 424)

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
XX
00ML;530MG/100ML;500MG/100ML
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA
5GM/100ML;30MG/100ML;37MG/100ML;222MG/1
XX
00ML;526MG/100ML;502MG/100ML
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;30MG/100ML;37MG/100ML;368MG/1
XX
00ML;526MG/100ML;502MG/100ML

N019843 001

Aug 09, 1993

N017609 001

N017451 001

DEXTROSE; POTASSIUM CHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
XX
XX
XX

INJECTABLE; INJECTION
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;75MG/100ML
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;150MG/100ML
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;224MG/100ML
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;300MG/100ML
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;75MG/100ML
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;150MG/100ML
5GM/100ML;150MG/100ML
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;300MG/100ML
5GM/100ML;300MG/100ML
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA
5GM/100ML;224MG/100ML
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;220MG/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

N017634 004
N017634 001
N017634 003
N017634 002
N018744 001

Nov 09, 1982

N018744 002
N019699 004

Nov 09, 1982

Sep 29, 1989

N018744 004
N019699 006

Nov 09, 1982

Sep 29, 1989

N018371 003
N018744 003

Nov 09, 1982

N018371 001
N018371 002

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
XX
/100ML;91MG/100ML

N019870 001

Jun 10, 1993

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE;

SODIUM LACTATE
INJECTABLE; INJECTION
DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;205MG/100ML;100MG/100ML;120MG
XX
/100ML;220MG/100ML

N018840 001

Jun 29, 1983

INJECTABLE; INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ
BAXTER HLTHCARE
AP
5GM/100ML;75MG/100ML;200MG/100ML
N018037 006
AP
5GM/100ML;150MG/100ML;200MG/100ML
N018037 007
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
BAXTER HLTHCARE
AP
5GM/100ML;224MG/100ML;200MG/100ML
N018037 004

Apr 13, 1982

Apr 13, 1982

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 129 (of 424)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

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
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
DEXTROSE 5%, SODIUM
BAXTER HLTHCARE
DEXTROSE 5%, SODIUM
BAXTER HLTHCARE
DEXTROSE 5%, SODIUM
BAXTER HLTHCARE
DEXTROSE 5%, SODIUM
BAXTER HLTHCARE
DEXTROSE 5%, SODIUM
BAXTER HLTHCARE
DEXTROSE 5%, SODIUM
BAXTER HLTHCARE
DEXTROSE 5%, SODIUM
BAXTER HLTHCARE

CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ

Apr 13, 1982
5GM/100ML;150MG/100ML;200MG/100ML
N018037 008
CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
5GM/100ML;300MG/100ML;200MG/100ML
N018037 001
CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ
Apr 13, 1982
5GM/100ML;224MG/100ML;200MG/100ML
N018037 005
CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
Apr 13, 1982
5GM/100ML;300MG/100ML;200MG/100ML
N018037 009
CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ
5GM/100ML;75MG/100ML;200MG/100ML
N018037 002
CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)
5GM/100ML;150MG/100ML;200MG/100ML
N018037 003
CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
Mar 23, 1982
5GM/100ML;75MG/100ML;330MG/100ML
N018629 005
Mar 23, 1982
5GM/100ML;150MG/100ML;330MG/100ML
N018629 002
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
BAXTER HLTHCARE
Mar 23, 1982
5GM/100ML;224MG/100ML;330MG/100ML
N018629 003
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
BAXTER HLTHCARE
Mar 23, 1982
5GM/100ML;150MG/100ML;330MG/100ML
N018629 004
Mar 23, 1982
5GM/100ML;300MG/100ML;330MG/100ML
N018629 006
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
BAXTER HLTHCARE
Mar 23, 1982
5GM/100ML;224MG/100ML;330MG/100ML
N018629 007
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
BAXTER HLTHCARE
Mar 23, 1982
5GM/100ML;300MG/100ML;330MG/100ML
N018629 008
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
BAXTER HLTHCARE
Mar 23, 1982
5GM/100ML;75MG/100ML;330MG/100ML
N018629 001
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
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
B BRAUN
Feb 17, 1988
5GM/100ML;75MG/100ML;200MG/100ML
N019630 008
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN
Feb 17, 1988
5GM/100ML;75MG/100ML;330MG/100ML
N019630 014
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
Feb 17, 1988
5GM/100ML;75MG/100ML;450MG/100ML
N019630 020
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
Feb 17, 1988
5GM/100ML;75MG/100ML;900MG/100ML
N019630 026
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN
Feb 17, 1988
5GM/100ML;150MG/100ML;200MG/100ML
N019630 010
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN
Feb 17, 1988
5GM/100ML;150MG/100ML;330MG/100ML
N019630 016
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
Feb 17, 1988
5GM/100ML;150MG/100ML;450MG/100ML
N019630 022
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
Feb 17, 1988
5GM/100ML;150MG/100ML;900MG/100ML
N019630 028
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN
Feb 17, 1988
5GM/100ML;300MG/100ML;200MG/100ML
N019630 012
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN
Feb 17, 1988
5GM/100ML;300MG/100ML;330MG/100ML
N019630 018
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
Feb 17, 1988
5GM/100ML;300MG/100ML;450MG/100ML
N019630 024
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Feb 17, 1988
B BRAUN
5GM/100ML;300MG/100ML;900MG/100ML
N019630 030
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE
Apr 28, 1982
5GM/100ML;75MG/100ML;450MG/100ML
N018008 005
Apr 28, 1982
5GM/100ML;150MG/100ML;450MG/100ML
N018008 006
HOSPIRA
Mar 28, 1988
5GM/100ML;74.5MG/100ML;450MG/100ML
N018362 005
Jul 05, 1983
5GM/100ML;74.5MG/100ML;450MG/100ML
N018362 009
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE
Apr 05, 1985
5GM/100ML;75MG/100ML;900MG/100ML
N019308 004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 130 (of 424)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

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
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX

INJECTABLE; INJECTION
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE
Apr 05, 1985
5GM/100ML;150MG/100ML;900MG/100ML
N019308 002
HOSPIRA
Mar 24, 1988
5GM/100ML;74.5MG/100ML;900MG/100ML
N019691 002
Mar 24, 1988
5GM/100ML;149MG/100ML;900MG/100ML
N019691 004
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA
Mar 28, 1988
5GM/100ML;224MG/100ML;450MG/100ML
N018362 006
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA
Mar 24, 1988
5GM/100ML;224MG/100ML;900MG/100ML
N019691 006
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE
Apr 28, 1982
5GM/100ML;150MG/100ML;450MG/100ML
N018008 007
HOSPIRA
Jul 05, 1983
5GM/100ML;149MG/100ML;450MG/100ML
N018362 010
Mar 28, 1988
5GM/100ML;298MG/100ML;450MG/100ML
N018362 007
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE
Apr 05, 1985
5GM/100ML;150MG/100ML;900MG/100ML
N019308 005
Apr 05, 1985
5GM/100ML;300MG/100ML;900MG/100ML
N019308 003
HOSPIRA
Mar 24, 1988
5GM/100ML;149MG/100ML;900MG/100ML
N019691 005
Mar 24, 1988
5GM/100ML;298MG/100ML;900MG/100ML
N019691 008
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE
Apr 28, 1982
5GM/100ML;224MG/100ML;450MG/100ML
N018008 008
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
Apr 05, 1985
5GM/100ML;224MG/100ML;900MG/100ML
N019308 006
HOSPIRA
Mar 24, 1988
5GM/100ML;224MG/100ML;900MG/100ML
N019691 007
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE
Apr 28, 1982
5GM/100ML;300MG/100ML;450MG/100ML
N018008 009
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
Apr 05, 1985
5GM/100ML;300MG/100ML;900MG/100ML
N019308 007
HOSPIRA
Mar 24, 1988
5GM/100ML;298MG/100ML;900MG/100ML
N019691 009
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
Mar 28, 1988
5GM/100ML;74.5MG/100ML;450MG/100ML
N018362 008
Mar 28, 1988
5GM/100ML;149MG/100ML;450MG/100ML
N018362 004
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE
Apr 05, 1985
5GM/100ML;150MG/100ML;900MG/100ML
N019308 001
HOSPIRA
Mar 24, 1988
5GM/100ML;74.5MG/100ML;900MG/100ML
N019691 001
Mar 24, 1988
5GM/100ML;149MG/100ML;900MG/100ML
N019691 003
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;37MG/100ML;200MG/100ML
N019630 031
Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;37MG/100ML;450MG/100ML
N019630 037
Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;37MG/100ML;900MG/100ML
N019630 043
Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;37MG/100ML;110MG/100ML
N019630 001
Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;37MG/100ML;200MG/100ML
N019630 007
Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;37MG/100ML;330MG/100ML
N019630 013
Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;37MG/100ML;450MG/100ML
N019630 019
Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;37MG/100ML;900MG/100ML
N019630 025
Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;75MG/100ML;200MG/100ML
N019630 032
Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;75MG/100ML;450MG/100ML
N019630 038
Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;75MG/100ML;900MG/100ML
N019630 044
Feb 17, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 131 (of 424)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX

INJECTABLE;
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN

INJECTION
CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
3.3GM/100ML;75MG/100ML;300MG/100ML
N019630 049
May 07, 1992
CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
5GM/100ML;75MG/100ML;110MG/100ML
N019630 002
Feb 17, 1988
CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
10GM/100ML;110MG/100ML;200MG/100ML
N019630 033
Feb 17, 1988
CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
10GM/100ML;110MG/100ML;450MG/100ML
N019630 039
Feb 17, 1988
CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
10GM/100ML;110MG/100ML;900MG/100ML
N019630 045
Feb 17, 1988
CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
3.3GM/100ML;110MG/100ML;300MG/100ML
N019630 050
May 07, 1992
CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
5GM/100ML;110MG/100ML;110MG/100ML
N019630 003
Feb 17, 1988
CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
5GM/100ML;110MG/100ML;200MG/100ML
N019630 009
Feb 17, 1988
CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
5GM/100ML;110MG/100ML;330MG/100ML
N019630 015
Feb 17, 1988
CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
5GM/100ML;110MG/100ML;450MG/100ML
N019630 021
Feb 17, 1988
CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
5GM/100ML;110MG/100ML;900MG/100ML
N019630 027
Feb 17, 1988
CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
10GM/100ML;150MG/100ML;200MG/100ML
N019630 034
Feb 17, 1988
CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
10GM/100ML;150MG/100ML;450MG/100ML
N019630 040
Feb 17, 1988
CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
10GM/100ML;150MG/100ML;900MG/100ML
N019630 046
Feb 17, 1988
CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
3.3GM/100ML;150MG/100ML;300MG/100ML
N019630 051
May 07, 1992
CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
5GM/100ML;150MG/100ML;110MG/100ML
N019630 004
Feb 17, 1988
CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
10GM/100ML;220MG/100ML;200MG/100ML
N019630 035
Feb 17, 1988
CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
10GM/100ML;220MG/100ML;450MG/100ML
N019630 041
Feb 17, 1988
CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
10GM/100ML;220MG/100ML;900MG/100ML
N019630 047
Feb 17, 1988
CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
3.3GM/100ML;220MG/100ML;300MG/100ML
N019630 052
May 07, 1992
CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
5GM/100ML;220MG/100ML;110MG/100ML
N019630 005
Feb 17, 1988
CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
5GM/100ML;220MG/100ML;200MG/100ML
N019630 011
Feb 17, 1988
CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
5GM/100ML;220MG/100ML;330MG/100ML
N019630 017
Feb 17, 1988
CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
5GM/100ML;220MG/100ML;450MG/100ML
N019630 023
Feb 17, 1988
CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
5GM/100ML;220MG/100ML;900MG/100ML
N019630 029
Feb 17, 1988
CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
10GM/100ML;300MG/100ML;200MG/100ML
N019630 036
Feb 17, 1988
CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
10GM/100ML;300MG/100ML;450MG/100ML
N019630 042
Feb 17, 1988
CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
10GM/100ML;300MG/100ML;900MG/100ML
N019630 048
Feb 17, 1988
CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
3.3GM/100ML;300MG/100ML;300MG/100ML
N019630 053
May 07, 1992
CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
5GM/100ML;300MG/100ML;110MG/100ML
N019630 006
Feb 17, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 132 (of 424)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE; INJECTION
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,
XX
5GM/100ML;149MG/100ML;225MG/100ML
N018365 006
Mar 28,
XX
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,
XX
5GM/100ML;149MG/100ML;300MG/100ML
N018876 006
Mar 28,
XX
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,
XX
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,
XX
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA
5GM/100ML;149MG/100ML;225MG/100ML
N018365 001
XX
5GM/100ML;298MG/100ML;225MG/100ML
N018365 009
Mar 28,
XX
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,
XX
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,
XX
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,
XX
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,
XX
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,
XX
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,
XX
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,
XX
5GM/100ML;149MG/100ML;225MG/100ML
N018365 007
Mar 28,
XX
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA
5GM/100ML;74.5MG/100ML;300MG/100ML
N018876 005
Mar 28,
XX
5GM/100ML;149MG/100ML;300MG/100ML
N018876 009
Mar 28,
XX

1983
1988
1986
1988
1988
1988

1988
1988
1986
1983
1986
1983
1988
1988
1988
1988
1988

DEXTROSE; SODIUM CHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;900MG/100ML
BAXTER HLTHCARE
10GM/100ML;900MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
2.5GM/100ML;450MG/100ML
BAXTER HLTHCARE
2.5GM/100ML;450MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;200MG/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
B BRAUN
5GM/100ML;450MG/100ML
HOSPIRA
5GM/100ML;450MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;900MG/100ML
HOSPIRA
5GM/100ML;900MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;200MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;330MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;450MG/100ML
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;900MG/100ML

N019631 015
N016696 001

Feb 24, 1988

N019631 004
N016697 001

Feb 24, 1988

N019631 007

Feb 24, 1988

N019631 008

Feb 24, 1988

N019631 009
N017607 001

Feb 24, 1988

N019631 010
N017585 001

Feb 24, 1988

N016689 001
N016687 001
N016683 001
N016678 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 133 (of 424)

DEXTROSE; SODIUM CHLORIDE

XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX

INJECTABLE; INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;110MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;200MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;330MG/100ML
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML;450MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN
2.5GM/100ML;110MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN
2.5GM/100ML;200MG/100ML
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN
2.5GM/100ML;330MG/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
B BRAUN
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 0.225% IN PLASTIC CONTAINER
HOSPIRA
5GM/100ML;225MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA
5GM/100ML;300MG/100ML

N019631 011

Feb 24, 1988

N019631 012

Feb 24, 1988

N019631 013

Feb 24, 1988

N019631 014

Feb 24, 1988

N019631 001

Feb 24, 1988

N019631 002

Feb 24, 1988

N019631 003

Feb 24, 1988

N019631 005

Feb 24, 1988

N019631 016

Jan 19, 1990

N019631 006

Feb 24, 1988

N017606 001
N017799 001

DIATRIZOATE MEGLUMINE
SOLUTION; URETHRAL
CYSTOGRAFIN
XX
BRACCO
CYSTOGRAFIN DILUTE
XX
BRACCO

30%

N010040 018

18%

N010040 022

Nov 09, 1982

66%;10%

N019292 001

Sep 29, 1989

66%;10%

N010040 001

66%;10%

N011245 003

66%;10%

A087388 001

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

INJECTABLE; INJECTION
MD-76R
AP + MALLINCKRODT
RENOGRAFIN-76
AP + BRACCO
SOLUTION; ORAL, RECTAL
GASTROGRAFIN
AA + BRACCO
MD-GASTROVIEW
MALLINCKRODT
AA

DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE

SOLUTION; INTRAUTERINE
SINOGRAFIN
XX + BRACCO

52.7%;26.8%

N011324 002

5MG/ML

A071415 001

Apr 03, 1987

2.5MG/0.5ML (5MG/ML)

N020648 001

Jul 29, 1997

10MG/2ML (5MG/ML)

N020648 007

Sep 15, 2005

DIAZEPAM
CONCENTRATE; ORAL
DIAZEPAM INTENSOL
XX + ROXANE
GEL; RECTAL
DIASTAT
VALEANT
XX
DIASTAT ACUDIAL
VALEANT
XX

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 134 (of 424)

DIAZEPAM
GEL; RECTAL

DIASTAT ACUDIAL

XX + VALEANT

20MG/4ML (5MG/ML)

N020648 006

Sep 15, 2005

INJECTABLE; INJECTION
DIAZEPAM
AP + HOSPIRA
AP
AP
WATSON LABS
AP

5MG/ML
5MG/ML
5MG/ML
5MG/ML

A071583
A071584
A072079
A070296

Oct
Oct
Dec
Feb

SOLUTION; ORAL

DIAZEPAM

XX + ROXANE

5MG/5ML

A070928 001

Apr 03, 1987

2MG
10MG
2MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG

A070152
A070154
A070226
A071307
A071321
A071322
A070325
A070325
A070325
A077749
A077749
A077749
A071134
A071135
A071136

Nov
Nov
Sep
Dec
Dec
Dec
Sep
Sep
Sep
Mar
Mar
Mar
Feb
Feb
Feb

2MG
5MG
10MG

N013263 002
N013263 004
N013263 006

50MG/ML

N017453 001

1.3%

N021234 001

Jan 31, 2007

CAPSULE; ORAL

ZIPSOR

XX + XANODYNE PHARM

25MG

N022202 001

Jun 16, 2009

FOR SOLUTION; ORAL

CAMBIA

XX + NAUTILUS NEUROSCIENC

50MG

N022165 001

Jun 17, 2009

50MG

N020142 002

Nov 24, 1993

50MG
50MG
50MG

A076561 001
A075463 001
A075229 001

Mar 18, 2004

Jul 26, 1999
Nov 20, 1998

TABLET; ORAL
DIAZEPAM
BARR
AB
AB
DAVA PHARMS INC
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
MYLAN
AB
AB
AB
VINTAGE PHARMS
AB
AB
AB
WATSON LABS
AB
AB
AB
VALIUM
ROCHE
AB
AB
AB +

001
001
001
001

001
001
001
001
001
001
002
003
001
001
002
003
001
001
001

13,
13,
20,
12,

01,
01,
26,
10,
10,
10,
04,
04,
04,
31,
31,
31,
03,
03,
03,

1987
1987
1988
1986

1985
1985
1985
1986
1986
1986
1985
1985
1985
2006
2006
2006
1987
1987
1987

DIAZOXIDE
SUSPENSION; ORAL

PROGLYCEM

XX + TEVA GLOBAL

DICLOFENAC EPOLAMINE
PATCH; TOPICAL

FLECTOR

XX + INST BIOCHEM

DICLOFENAC POTASSIUM

AB
AB
AB
AB

TABLET; ORAL
CATAFLAM
+ NOVARTIS
DICLOFENAC POTASSIUM
APOTEX
MYLAN
SANDOZ

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 135 (of 424)

DICLOFENAC POTASSIUM
TABLET; ORAL
DICLOFENAC POTASSIUM
TEVA
AB

50MG

A075219 001

Aug 06, 1998

DICLOFENAC SODIUM
GEL; TOPICAL

SOLARAZE

XX + FOUGERA PHARMS
VOLTAREN
XX + NOVARTIS

3%

N021005 001

Oct 16, 2000

1%

N022122 001

Oct 17, 2007

SOLUTION; TOPICAL

PENNSAID

XX + MALLINCKRODT

1.5%

N020947 001

Nov 04, 2009

A077845
A078031
A077600
A078792
A078553

Apr
Feb
Nov
Dec
Dec

AT
AT
AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
DICLOFENAC SODIUM
AKORN
0.1%
ALCON PHARMS LTD
0.1%
APOTEX INC
0.1%
BAUSCH AND LOMB
0.1%
NEXUS PHARMS
0.1%
VOLTAREN
+ NOVARTIS
0.1%

AB
AB
AB
AB
AB

17,
06,
13,
28,
28,

2008
2008
2008
2007
2007

N020037 001

Mar 28, 1991

A074514
A074514
A075281
A075281
A075185
A075185
A075185
A074376
A074376
A074394
A090066
A090066
A077863

001
002
002
003
002
003
001
001
002
001
001
002
003

Mar
Mar
Feb
Feb
Nov
Nov
Nov
Sep
Sep
Nov
Dec
Dec
Jun

26,
26,
12,
12,
13,
13,
13,
28,
28,
30,
01,
01,
08,

1996
1996
2002
2002
1998
1998
1998
1995
1995
1995
2010
2010
2007

100MG
100MG
100MG
100MG

A075910
A076201
A076152
A075492

001
001
001
001

Jan
Nov
Dec
Feb

07,
06,
13,
11,

2002
2002
2001
2000

100MG

N020254 001

Mar 08, 1996

N020607 001
N020607 002

Dec 24, 1997

Dec 24, 1997

A061454 001
A061454 003
A062286 001

Jun 03, 1982

TABLET, DELAYED RELEASE; ORAL

DICLOFENAC SODIUM
ACTAVIS ELIZABETH
AB
50MG
AB
75MG
ALPHAPHARM
AB
50MG
AB
75MG
CARLSBAD
AB
25MG
AB
50MG
AB
75MG
AB + SANDOZ
25MG
AB +
50MG
AB +
75MG
UNIQUE PHARM LABS
AB
25MG
AB
50MG
AB
75MG
TABLET, EXTENDED RELEASE;
DICLOFENAC SODIUM
ACTAVIS ELIZABETH
DEXCEL LTD
MYLAN
VALEANT INTL
VOLTAREN-XR
+ NOVARTIS

001
001
001
001
001

ORAL

DICLOFENAC SODIUM; MISOPROSTOL

TABLET, DELAYED RELEASE; ORAL
ARTHROTEC
GD SEARLE LLC
50MG;0.2MG
XX
75MG;0.2MG
XX +

DICLOXACILLIN SODIUM
CAPSULE; ORAL
DICLOXACILLIN SODIUM
SANDOZ
AB
AB +
TEVA
AB

EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 136 (of 424)

DICLOXACILLIN SODIUM
CAPSULE; ORAL
DICLOXACILLIN SODIUM
TEVA
AB
DICLOXACILLIN SODIUM
SANDOZ
XX

EQ 500MG BASE

A062286 002

EQ 125MG BASE

A061454 002

Jun 03, 1982

DICYCLOMINE HYDROCHLORIDE

AB
AB
AB
AB
AB

CAPSULE; ORAL
BENTYL
+ APTALIS PHARMA US
10MG
DICYCLOMINE HYDROCHLORIDE
LANNETT
10MG
MYLAN
10MG
WATSON LABS
10MG
WEST WARD
10MG

INJECTABLE; INJECTION
BENTYL
AP + APTALIS PHARMA US
10MG/ML
BENTYL PRESERVATIVE FREE
AP + APTALIS PHARMA US
10MG/ML
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE)
BEDFORD
AP
10MG/ML
SYRUP; ORAL
BENTYL
AA + APTALIS PHARMA US
10MG/5ML
DICYCLOMINE HYDROCHLORIDE
MIKART
AA
10MG/5ML

AB
AB
AB
AB
AB

TABLET; ORAL
BENTYL
+ APTALIS PHARMA US
20MG
DICYCLOMINE HYDROCHLORIDE
LANNETT
20MG
MYLAN
20MG
WATSON LABS
20MG
WEST WARD
20MG

N007409 003

Oct 15, 1984

A084285
A040319
A085082
A040204

001
001
001
001

Sep 07, 1999

Jun 19, 1986
Feb 28, 1997

N008370 001

Oct 15, 1984

N008370 002

Oct 15, 1984

A040465 001

Jun 30, 2003

N007961 002

Oct 15, 1984

A040169 001

Mar 24, 2005

N007409 001

Oct 15, 1984

A040230
A040317
A085223
A040161

001
001
001
001

Feb
Sep
Jul
Oct

26,
07,
30,
01,

1999
1999
1986
1996

DIDANOSINE
CAPSULE, DELAYED REL PELLETS; ORAL
DIDANOSINE
AUROBINDO PHARMA
125MG
AB
200MG
AB
250MG
AB
400MG
AB
BARR
200MG
AB
250MG
AB
400MG
AB
MATRIX LABS LTD
125MG
AB
200MG
AB
250MG
AB
400MG
AB
VIDEX EC
BRISTOL MYERS SQUIBB 125MG
AB
200MG
AB
250MG
AB
400MG
AB +

A090094
A090094
A090094
A090094
A077167
A077167
A077167
A090788
A090788
A090788
A090788

001
002
003
004
001
002
003
001
002
003
004

Sep
Sep
Sep
Sep
Dec
Dec
Dec
Apr
Apr
Apr
Apr

24,
24,
24,
24,
03,
03,
03,
08,
08,
08,
08,

2008
2008
2008
2008
2004
2004
2004
2010
2010
2010
2010

N021183
N021183
N021183
N021183

001
002
003
004

Oct
Oct
Oct
Oct

31,
31,
31,
31,

2000
2000
2000
2000

FOR SOLUTION; ORAL

DIDANOSINE
AUROBINDO PHARMA
AA

A078112 001

10MG/ML

Mar 08, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 137 (of 424)

DIDANOSINE
FOR SOLUTION; ORAL

VIDEX

AA + BRISTOL MYERS SQUIBB

10MG/ML

N020156 001

Oct 09, 1991

N022252 001

May 06, 2010

A201212 001
A040828 001
A200177 001

Dec 22, 2010

Nov 05, 2008
Jul 18, 2011

DIENOGEST; ESTRADIOL VALERATE

TABLET; ORAL-28

NATAZIA

XX + BAYER HLTHCARE

N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A

DIETHYLPROPION HYDROCHLORIDE

AA
AA
AA
AA

TABLET; ORAL
DIETHYLPROPION HYDROCHLORIDE
AVANTHI INC
25MG
COREPHARMA
25MG
LANNETT HOLDINGS INC 25MG
TENUATE
+ WATSON PHARMS
25MG

TABLET, EXTENDED RELEASE; ORAL

DIETHYLPROPION HYDROCHLORIDE
LANNETT HOLDINGS INC 75MG
AB
TENUATE DOSPAN
AB + WATSON PHARMS
75MG

N011722 002

A091680 001

Oct 24, 2011

N012546 001

DIFLORASONE DIACETATE
CREAM; TOPICAL
DIFLORASONE DIACETATE
AB1 + ALTANA
TARO
AB1
DIFLORASONE DIACETATE
BX + ALTANA

0.05%
0.05%

A075187 001
A075508 001

Mar 30, 1998

Apr 24, 2000

0.05%

A076263 001

Dec 20, 2002

OINTMENT; TOPICAL
DIFLORASONE DIACETATE
ALTANA
AB
AB + TARO

0.05%
0.05%

A075374 001
A075331 001

Apr 27, 1999

May 14, 1999

500MG

A073673 001

Jul 31, 1992

0.05%

N022212 001

Jun 23, 2008

0.05MG/ML

N021648 001

Aug 26, 2004

0.25MG/ML
0.25MG/ML
0.25MG/ML

A083391 001
A040093 001
A040481 001

May 16, 1996

Aug 21, 2003

0.25MG/ML

N009330 002

0.1MG/ML

N009330 004

DIFLUNISAL
TABLET; ORAL

DIFLUNISAL

XX + TEVA

DIFLUPREDNATE
EMULSION; OPHTHALMIC

DUREZOL

XX + ALCON PHARMS LTD

DIGOXIN
ELIXIR; ORAL

DIGOXIN

XX + ROXANE

AP
AP
AP
AP
XX

INJECTABLE; INJECTION
DIGOXIN
BAXTER HLTHCARE
HOSPIRA
SANDOZ
LANOXIN
+ COVIS PHARMA
LANOXIN PEDIATRIC
+ COVIS PHARMA

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 138 (of 424)

DIGOXIN
TABLET; ORAL
DIGOXIN
CARACO
AB
AB
IMPAX LABS
AB
AB
STEVENS J
AB
AB
WEST WARD
AB
AB
LANOXIN
COVIS PHARMA
AB
AB +

0.125MG
0.25MG
0.125MG
0.25MG
0.125MG
0.25MG
0.125MG
0.25MG

A076363
A076363
A078556
A078556
A076268
A076268
A077002
A077002

001
002
001
002
001
002
002
001

0.125MG
0.25MG

N020405 002
N020405 004

Jan
Jan
Jul
Jul
Jul
Jul
Oct
Oct

31,
31,
20,
20,
26,
26,
30,
30,

2003
2003
2009
2009
2002
2002
2007
2007

Sep 30, 1997

Sep 30, 1997

DIHYDROERGOTAMINE MESYLATE
INJECTABLE; INJECTION
D.H.E. 45
AP + VALEANT
1MG/ML
DIHYDROERGOTAMINE MESYLATE
BEDFORD LABS
AP
1MG/ML
PADDOCK LLC
AP
1MG/ML

A040453 001
A040475 001

Jun 09, 2003

Apr 28, 2003

SPRAY, METERED; NASAL

MIGRANAL

XX + VALEANT

N020148 001

Dec 08, 1997

N020092 001
N020092 002
N020092 003

May 29, 1992

May 29, 1992
May 29, 1992

A074943
A074943
A074943
A075124
A075124
A075124
A074852
A074852
A074852

003
002
001
002
003
001
001
002
003

Dec
Dec
Aug
Mar
Mar
Mar
Oct
Oct
Oct

19,
19,
06,
18,
18,
18,
10,
10,
10,

2000
2000
1998
1998
1998
1998
1997
1997
1997

N020062
N020062
N020062
N020062
N020062

001
002
003
004
005

Aug
Dec
Dec
Dec
Aug

10,
27,
27,
27,
24,

1992
1991
1991
1991
1999

A074752
A074752
A074752
A074752

002
001
003
004

Jul
Jul
Jul
Jul

09,
09,
09,
09,

1998
1998
1998
1998

A076151
A076151
A076151
A076151

001
002
003
004

May
May
May
May

20,
20,
20,
20,

2004
2004
2004
2004

0.5MG/INH

N005929 001

DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
DILACOR XR
WATSON LABS
AB2
120MG
AB2
180MG
AB2 +
240MG
DILTIAZEM HYDROCHLORIDE
APOTEX
AB2
120MG
AB2
180MG
AB2
240MG
MYLAN
AB2
120MG
AB2
180MG
AB2
240MG
WATSON LABS FLORIDA
AB2
120MG
AB2
180MG
AB2
240MG
CARDIZEM CD
VALEANT INTL
AB3
120MG
AB3
180MG
AB3
240MG
AB3
300MG
AB3 +
360MG
CARTIA XT
WATSON LABS FLORIDA
AB3
120MG
AB3
180MG
AB3
240MG
AB3
300MG
DILT-CD
APOTEX
AB3
120MG
AB3
180MG
AB3
240MG
AB3
300MG
DILTIAZEM HYDROCHLORIDE
ACTAVIS ELIZABETH
AB3
120MG

A074984 001

Dec 20, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 139 (of 424)

DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
DILTIAZEM HYDROCHLORIDE
ACTAVIS ELIZABETH
AB3
180MG
AB3
240MG
AB3
300MG
SUN PHARMA GLOBAL
AB3
120MG
AB3
180MG
AB3
240MG
AB3
300MG
AB3
360MG
VALEANT INTL
AB3
120MG
AB3
180MG
AB3
240MG
AB3
300MG
DILTIAZEM HYDROCHLORIDE
NESHER PHARMS
AB4
120MG
AB4
180MG
AB4
240MG
AB4
300MG
AB4
360MG
AB4
420MG
SUN PHARMA GLOBAL
AB4
120MG
AB4
180MG
AB4
240MG
AB4
300MG
AB4
360MG
DILTZAC
APOTEX INC
AB4
120MG
AB4
180MG
AB4
240MG
AB4
300MG
AB4
360MG
TAZTIA XT
WATSON LABS FLORIDA
AB4
120MG
AB4
180MG
AB4
240MG
AB4
300MG
AB4
360MG
TIAZAC
VALEANT INTL
AB4
120MG
AB4
180MG
AB4
240MG
AB4
300MG
AB4
360MG
AB4 +
420MG
DILTIAZEM HYDROCHLORIDE
BC + MYLAN
120MG
DILTIAZEM HYDROCHLORIDE
MYLAN
60MG
XX
90MG
XX

AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
DILTIAZEM HYDROCHLORIDE
APOTEX INC
BAXTER HLTHCARE
+ BEDFORD
HOSPIRA
INTL MEDICATION
TAYLOR PHARMA
TEVA PARENTERAL

5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML

A074984
A074984
A074984
A090492
A090492
A090492
A090492
A090492
A075116
A075116
A075116
A075116

002
003
004
001
002
003
004
005
001
002
003
004

Dec
Dec
Dec
Oct
Oct
Oct
Oct
Oct
Dec
Dec
Dec
Dec

20,
20,
20,
28,
28,
28,
28,
28,
23,
23,
23,
23,

1999
1999
1999
2011
2011
2011
2011
2011
1999
1999
1999
1999

A076563
A076563
A076563
A076563
A076563
A076563
A090421
A090421
A090421
A090421
A090421

002
003
004
005
006
001
001
002
003
004
005

Sep
Sep
Sep
Sep
Sep
Sep
Nov
Nov
Nov
Nov
Nov

12,
12,
12,
12,
12,
12,
15,
15,
15,
15,
15,

2006
2006
2006
2006
2006
2006
2010
2010
2010
2010
2010

A076395
A076395
A076395
A076395
A076395

001
002
003
004
005

Feb
Feb
Feb
Feb
Feb

01,
01,
01,
01,
01,

2006
2006
2006
2006
2006

A075401
A075401
A075401
A075401
A075401

001
002
003
004
005

Apr
Apr
Apr
Apr
Apr

10,
10,
10,
10,
10,

2003
2003
2003
2003
2003

N020401
N020401
N020401
N020401
N020401
N020401

001
002
003
004
005
006

Sep
Sep
Sep
Sep
Sep
Oct

11,
11,
11,
11,
11,
16,

1995
1995
1995
1995
1995
1998

A074910 003

May 02, 1997

A074910 001
A074910 002

May 02, 1997

May 02, 1997

A075375
A078538
A074617
A074941
A075749
A075086
A074894

Sep
Dec
Feb
Apr
Nov
Apr
Aug

001
001
001
001
001
001
001

30,
17,
28,
15,
21,
09,
26,

1999
2008
1996
1998
2001
1998
1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 140 (of 424)

DILTIAZEM HYDROCHLORIDE
INJECTABLE; INJECTION

DILTIAZEM HYDROCHLORIDE

100MG/VIAL
XX + HOSPIRA
10MG/ML
XX + TEVA PARENTERAL
TABLET; ORAL
CARDIZEM
VALEANT INTL
AB
AB
AB
AB +
DILTIAZEM HYDROCHLORIDE
DAVA PHARMS INC
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
TEVA
AB
AB
AB
AB

A075853 001
A074894 002

Dec 17, 2002

Apr 19, 2002

30MG
60MG
90MG
120MG

N018602
N018602
N018602
N018602

001
002
003
004

Nov
Nov
Dec
Dec

05,
05,
08,
08,

1982
1982
1986
1986

30MG
60MG
90MG
120MG
30MG
60MG
90MG
120MG
30MG
60MG
90MG
120MG

A074093
A074093
A074093
A074093
A072838
A072838
A072838
A072838
A074185
A074185
A074185
A074185

001
002
003
004
004
003
002
001
001
002
003
004

Nov
Nov
Nov
Nov
Nov
Nov
Nov
Nov
May
May
May
May

05,
05,
05,
05,
05,
05,
05,
05,
31,
31,
31,
31,

1992
1992
1992
1992
1992
1992
1992
1992
1995
1995
1995
1995

N021392
N021392
N021392
N021392
N021392
N021392

001
002
003
004
005
006

Feb
Feb
Feb
Feb
Feb
Feb

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

2003
2003
2003
2003
2003
2003

A077686
A077686
A077686
A077686
A077686
A077686

006
005
004
003
002
001

Mar
Mar
Mar
Mar
Mar
Mar

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

2010
2010
2010
2010
2010
2010

TABLET, EXTENDED RELEASE; ORAL

CARDIZEM LA
VALEANT INTL
AB
120MG
AB
180MG
AB
240MG
AB
300MG
AB
360MG
AB +
420MG
DILTIAZEM HYDROCHLORIDE
WATSON LABS FLORIDA
AB
120MG
AB
180MG
AB
240MG
AB
300MG
AB
360MG
AB
420MG

DIMENHYDRINATE
INJECTABLE; INJECTION
DIMENHYDRINATE
APP PHARMS
AP
AP + WATSON LABS

50MG/ML
50MG/ML

A040519 001
A080615 001

10%

N005939 001

50%

A076185 001

50%

N017788 001

Jun 23, 2004

DIMERCAPROL
INJECTABLE; INJECTION

BAL

XX + AKORN

DIMETHYL SULFOXIDE
SOLUTION; INTRAVESICAL
DIMETHYL SULFOXIDE
BIONICHE PHARMA
AT
RIMSO-50
AT + BIONICHE PHARMA

Nov 29, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 141 (of 424)

DINOPROSTONE
GEL; ENDOCERVICAL

PREPIDIL

XX + PHARMACIA AND UPJOHN

0.5MG/3GM

N019617 001

Dec 09, 1992

INSERT, EXTENDED RELEASE; VAGINAL

CERVIDIL

10MG
XX + CONTROLLED THERAP

N020411 001

Mar 30, 1995

SUPPOSITORY; VAGINAL

PROSTIN E2

XX + PHARMACIA AND UPJOHN

N017810 001

20MG

DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

50MG
XX + BARR

A080738 001

ELIXIR; ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

12.5MG/5ML
XX + PHARM ASSOC

A087513 001

AP
AP
AP
AP
AP
AP
AP
AP
AP
XX

INJECTABLE; INJECTION
BENADRYL
+ MCNEIL CONS
50MG/ML
BENADRYL PRESERVATIVE FREE
+ MCNEIL CONS
50MG/ML
DIPHENHYDRAMINE HYDROCHLORIDE
APP PHARMS
50MG/ML
BAXTER HLTHCARE
50MG/ML
BIONICHE PHARMA
50MG/ML
HOSPIRA
50MG/ML
WATSON LABS
50MG/ML
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
INTL MEDICATION
50MG/ML
WATSON LABS
50MG/ML
DIPHENHYDRAMINE HYDROCHLORIDE
+ WATSON LABS
10MG/ML

Feb 10, 1982

N006146 002
N009486 001
A040466
A080817
A040498
A040140
A080873

001
002
001
001
002

May 28, 2002

Jul 12, 2005
Nov 20, 1998

A084094 001
A080873 003
A080873 001

DIPIVEFRIN HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
AKPRO
AKORN
AT
0.1%
DIPIVEFRIN HYDROCHLORIDE
FALCON PHARMS
AT
0.1%
PROPINE
AT + ALLERGAN
0.1%

A074382 001

Sep 29, 1995

A073636 001

Jun 30, 1994

N018239 001

DIPYRIDAMOLE

AP
AP
AP
AP
AP

INJECTABLE; INJECTION
DIPYRIDAMOLE
APP PHARMS
BAXTER HLTHCARE
+ BEDFORD
CLARIS LIFESCIENCES
TEVA PARENTERAL

TABLET; ORAL
DIPYRIDAMOLE
BARR
AB
AB
AB
GLENMARK GENERICS
AB
AB

5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML

A074956
A074521
A074939
A075769
A074952

001
001
001
001
001

Sep
Oct
Apr
Nov
Nov

30,
18,
13,
27,
26,

1998
1996
1998
2002
1997

25MG
50MG
75MG
25MG
50MG

A087184
A087716
A087717
A088999
A089000

001
001
001
001
001

Oct
Oct
Oct
Feb
Feb

03,
03,
03,
05,
05,

1990
1990
1990
1991
1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 142 (of 424)

DIPYRIDAMOLE
TABLET; ORAL
DIPYRIDAMOLE
GLENMARK GENERICS
AB
IMPAX LABS
AB
AB
AB
LANNETT
AB
AB
AB
MURTY PHARMS
AB
AB
AB
PROSAM LABS
AB
AB
AB
PUREPAC PHARM
AB
WATSON LABS
AB
ZYDUS PHARMS USA INC
AB
AB
AB
PERSANTINE
BOEHRINGER INGELHEIM
AB
AB
AB +

001
001
002
003
001
002
003
001
002
003
001
002
003
001
001
001
002
003

Feb
Jul
Jul
Jul
Apr
Apr
Apr
Feb
Feb
Feb
Apr
Apr
Apr
Jul
Jun
Jan
Jan
Jan

05,
18,
18,
18,
23,
23,
23,
13,
13,
13,
21,
21,
21,
12,
07,
28,
28,
28,

1991
2007
2007
2007
2008
2008
2008
2007
2007
2007
2006
2006
2006
1990
1996
2008
2008
2008

75MG
25MG
50MG
75MG
25MG
50MG
75MG
25MG
50MG
75MG
25MG
50MG
75MG
25MG
50MG
25MG
50MG
75MG

A089001
A040782
A040782
A040782
A040898
A040898
A040898
A040733
A040733
A040733
A040542
A040542
A040542
A089425
A087160
A040874
A040874
A040874

25MG
50MG
75MG

N012836 003
N012836 004
N012836 005

Dec 22, 1986

Feb 06, 1987
Feb 06, 1987

A070101
A070102
A070173
A070174

Feb
Feb
May
May

DISOPYRAMIDE PHOSPHATE
CAPSULE; ORAL
DISOPYRAMIDE PHOSPHATE
TEVA
AB
AB
WATSON LABS
AB
AB
NORPACE
GD SEARLE LLC
AB
AB +

EQ
EQ
EQ
EQ

100MG
150MG
100MG
150MG

BASE
BASE
BASE
BASE

EQ 100MG BASE
EQ 150MG BASE

CAPSULE, EXTENDED RELEASE; ORAL

DISOPYRAMIDE PHOSPHATE
NESHER PHARMS
AB
EQ 150MG BASE
NORPACE CR
AB + GD SEARLE LLC
EQ 150MG BASE
NORPACE CR
GD SEARLE LLC
EQ 100MG BASE
XX

001
001
001
001

22,
22,
31,
31,

1985
1985
1985
1985

N017447 001
N017447 002

A071200 001

Dec 15, 1987

N018655 002

Jul 20, 1982

N018655 001

Jul 20, 1982

250MG
500MG

A088482 001
A088483 001

Dec 08, 1983

Dec 08, 1983

250MG
500MG

A091619 001
A091619 002

Mar 28, 2011

Mar 28, 2011

N019680 001

Sep 12, 1989

A078979 001
A090407 001

Jan 23, 2009

Mar 28, 2011

DISULFIRAM
TABLET; ORAL
ANTABUSE
ODYSSEY PHARMS
AB
AB +
DISULFIRAM
SIGMAPHARM LABS LLC
AB
AB

DIVALPROEX SODIUM
CAPSULE, DELAYED REL PELLETS; ORAL
DEPAKOTE
AB + ABBOTT
EQ 125MG VALPROIC ACID
DIVALPROEX SODIUM
DR REDDYS LABS LTD
AB
EQ 125MG VALPROIC ACID
MYLAN
AB
EQ 125MG VALPROIC ACID

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 143 (of 424)

DIVALPROEX SODIUM
CAPSULE, DELAYED REL PELLETS; ORAL
DIVALPROEX SODIUM
ZYDUS PHARMS USA INC EQ 125MG VALPROIC ACID
AB

A078919 001

Jan 27, 2009

TABLET, DELAYED RELEASE; ORAL

DEPAKOTE
ABBOTT
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB +
EQ 500MG VALPROIC ACID
DIVALPROEX SODIUM
ANCHEN PHARMS
AB
EQ 500MG VALPROIC ACID
AUROBINDO PHARMA LTD EQ 125MG VALPROIC ACID
AB
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
DR REDDYS LABS LTD
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
LUPIN
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
MYLAN
AB
EQ 125MG VALPROIC ACID
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
NU PHARM
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
ORCHID HLTHCARE
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
SANDOZ
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
SUN PHARM INDS
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
TEVA
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
UNICHEM LABS LTD
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
UPSHER SMITH
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
VINTAGE
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
WATSON LABS FLORIDA
AB
EQ 500MG VALPROIC ACID
WOCKHARDT
AB
EQ 125MG VALPROIC ACID
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID
ZYDUS PHARMS USA INC EQ 125MG VALPROIC ACID
AB
AB
EQ 250MG VALPROIC ACID
AB
EQ 500MG VALPROIC ACID

N018723 003
N018723 001
N018723 002

Oct 26, 1984

Mar 10, 1983
Mar 10, 1983

A078411
A090554
A090554
A090554
A078755
A078755
A078755
A078790
A078790
A078790
A077254
A090062
A077254
A090062
A077254
A090062
A077615
A077615
A077615
A078853
A078853
A078853
A078290
A078290
A078290
A078597
A078597
A078597
A076941
A076941
A076941
A079163
A079163
A079163
A078182
A078182
A078182
A090210
A090210
A090210
A079080
A077296
A077296
A077296
A077100
A077100
A077100

Nov
Apr
Apr
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Mar
Jul
Mar
Jul
Mar
Jul
Jul
Jul
Nov
Nov
Nov
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Apr
Apr
Apr
Jul
Jul
Jul
Nov
Nov
Nov
Feb
Jul
Jul
Jul
Mar
Mar
Mar

TABLET, EXTENDED RELEASE; ORAL

DEPAKOTE ER
ABBOTT
AB
EQ 250MG VALPROIC ACID

N021168 002

001
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
003
002
001
001
002
003
003
002
001
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
003
001
002
003

03,
21,
21,
21,
29,
29,
29,
29,
29,
29,
29,
17,
29,
17,
29,
17,
29,
29,
29,
25,
25,
25,
29,
29,
29,
29,
29,
29,
29,
29,
29,
05,
05,
05,
29,
29,
29,
30,
30,
30,
25,
31,
31,
31,
05,
05,
05,

2008
2011
2011
2011
2008
2008
2008
2008
2008
2008
2008
2009
2008
2009
2008
2009
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2011
2011
2011
2008
2008
2008
2009
2009
2009
2011
2008
2008
2008
2009
2009
2009

May 31, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 144 (of 424)

DIVALPROEX SODIUM
TABLET, EXTENDED RELEASE; ORAL
DEPAKOTE ER
AB + ABBOTT
EQ 500MG
DIVALPROEX SODIUM
ANCHEN PHARMS
AB
EQ 250MG
AB
EQ 500MG
IMPAX LABS
AB
EQ 250MG
AB
EQ 500MG
MYLAN
AB
EQ 250MG
AB
EQ 500MG
TEVA PHARMS
AB
EQ 500MG
WOCKHARDT
AB
EQ 250MG
AB
EQ 500MG
ZYDUS PHARMS USA INC EQ 250MG
AB
AB
EQ 500MG

VALPROIC ACID

N021168 001

Aug 04, 2000

VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC
VALPROIC

A078445
A078445
A078791
A078791
A077567
A077567
A078700
A078705
A078705
A078239
A078239

001
002
001
002
001
002
001
002
001
001
002

Feb
Aug
May
Aug
Jan
Jan
Aug
Feb
Aug
Feb
Aug

26,
04,
06,
04,
29,
29,
03,
10,
04,
27,
04,

2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009

A074277
A074086
A074292
A074114

001
001
001
001

Oct
Nov
Feb
Nov

31,
29,
16,
30,

1994
1993
1995
1993

ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID
ACID

DOBUTAMINE HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
DOBUTAMINE HYDROCHLORIDE
BEDFORD
EQ 12.5MG BASE/ML
HOSPIRA
EQ 12.5MG BASE/ML
+
EQ 12.5MG BASE/ML
WATSON LABS
EQ 12.5MG BASE/ML
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
+ HOSPIRA
EQ 50MG BASE/100ML
+
EQ 100MG BASE/100ML
+
EQ 200MG BASE/100ML
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
EQ 50MG BASE/100ML
+
EQ 100MG BASE/100ML
+
EQ 200MG BASE/100ML
+
EQ 400MG BASE/100ML
+ HOSPIRA
EQ 50MG BASE/100ML
+
EQ 100MG BASE/100ML
+
EQ 200MG BASE/100ML
+
EQ 400MG BASE/100ML

N020269 001
N020269 002
N020269 003

Oct 19, 1993

Oct 19, 1993
Oct 19, 1993

N020255
N020255
N020255
N020255
N020201
N020201
N020201
N020201

001
003
004
005
003
002
001
006

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Jul

19,
19,
19,
19,
19,
19,
19,
07,

1993
1993
1993
1993
1993
1993
1993
1994

20MG/2ML (10MG/ML)
80MG/8ML (10MG/ML)
160MG/16ML (10MG/ML)
20MG/2ML (10MG/ML)
160MG/16ML (10MG/ML)
80MG/8ML (10MG/ML)

N022234
N022234
N022234
N201525
N201525
N201525

001
002
003
001
003
002

Mar
Mar
Mar
Jun
Jun
Jun

08,
08,
08,
29,
29,
29,

2011
2011
2011
2011
2011
2011

20MG/VIAL
80MG/VIAL

N022534 001
N022534 002

May 03, 2011

May 03, 2011

20MG/0.5ML (40MG/ML)
80MG/2ML (40MG/ML)

N201195 001
N201195 002

Jun 08, 2011

Jun 08, 2011

20MG/ML (20MG/ML)
80MG/4ML (20MG/ML)

N020449 003
N020449 004

Aug 03, 2010

Aug 02, 2010

DOCETAXEL

AP
AP
AP
AP
AP
AP
XX
XX
XX
XX
XX
XX

INJECTABLE; INJECTION
DOCETAXEL
+ HOSPIRA INC
+
+
SANDOZ
SANDOZ INC
DOCEFREZ
+ SUN PHARMA GLOBAL
+
DOCETAXEL
ACCORD HLTHCARE
TAXOTERE
+ SANOFI AVENTIS US
+

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 145 (of 424)

DOFETILIDE
CAPSULE; ORAL
TIKOSYN
PFIZER
XX
XX
XX +

0.125MG
0.25MG
0.5MG

N020931 001
N020931 002
N020931 003

Oct 01, 1999

Oct 01, 1999
Oct 01, 1999

INJECTABLE; INJECTION

ANZEMET

XX + SANOFI AVENTIS US
XX +
XX +

12.5MG/0.625ML (20MG/ML)
100MG/5ML (20MG/ML)
500MG/25ML (20MG/ML)

N020624 002
N020624 001
N020624 003

Sep 11, 1997

Sep 11, 1997
Dec 11, 2001

TABLET; ORAL
ANZEMET
SANOFI AVENTIS US
XX
XX +

50MG
100MG

N020623 001
N020623 002

Sep 11, 1997

Sep 11, 1997

N020690 002
N020690 001

Nov 25, 1996

Nov 25, 1996

A201335
A201335
A090551
A090551
A078841
A078841
A090056
A090056
A077518
A077518
A201001
A201001
A090247
A090247
A200292
A200292
A090768
A090768
A090521
A090521
A090425
A090425
A076786
A076786
A078662
A078662
A090290
A090290
A090493
A090493
A077344
A077344
A090686
A090686
A091267
A091267

Aug
Aug
May
May
Jun
Jun
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
Nov
Nov
May
May
May
May
May
May
May
May
May
May
May
May

DOLASETRON MESYLATE

DONEPEZIL HYDROCHLORIDE
TABLET; ORAL
ARICEPT
EISAI INC
AB
5MG
AB +
10MG
DONEPEZIL HYDROCHLORIDE
ACCORD HLTHCARE
AB
5MG
AB
10MG
ACTAVIS PHARMA
AB
5MG
AB
10MG
APOTEX
AB
5MG
AB
10MG
AUROBINDO
AB
5MG
AB
10MG
CIPLA LTD
AB
5MG
AB
10MG
DR REDDYS LABS LTD
AB
5MG
AB
10MG
HIKMA PHARMS
AB
5MG
AB
10MG
HUAHAI US INC
AB
5MG
AB
10MG
JUBILANT LIFE
AB
5MG
AB
10MG
MATRIX LABS LTD
AB
5MG
AB
10MG
PLIVA HRVATSKA DOO
AB
5MG
AB
10MG
RANBAXY
AB
5MG
AB
10MG
ROXANE
AB
5MG
AB
10MG
SANDOZ
AB
5MG
AB
10MG
SUN PHARM INDS
AB
5MG
AB
10MG
TEVA
AB
5MG
AB
10MG
TORRENT PHARMS
AB
5MG
AB
10MG
WOCKHARDT
AB
5MG
AB
10MG

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

29,
29,
31,
31,
02,
02,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,
26,
26,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,

2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2010
2010
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 146 (of 424)

DONEPEZIL HYDROCHLORIDE
TABLET; ORAL

ARICEPT

XX + EISAI INC

AB
AB
AB
AB
AB
AB
AB
AB

23MG

TABLET, ORALLY DISINTEGRATING; ORAL

ARICEPT ODT
EISAI INC
5MG
+
10MG
DONEPEZIL HYDROCHLORIDE
BARR
5MG
10MG
SANDOZ
5MG
10MG
ZYDUS PHARMS USA INC 5MG
10MG

N022568 001

Jul 23, 2010

N021720 001
N021720 002

Oct 18, 2004

Oct 18, 2004

A078388
A078388
A091198
A091198
A090175
A090175

002
001
001
002
001
002

Nov
Nov
May
May
May
May

26,
26,
10,
10,
10,
10,

2010
2010
2011
2011
2011
2011

N018132
N018132
N018132
N018132
A070799
A070820
A070826

001
002
004
003
001
001
001

Feb
Jul
Feb
Feb
Feb
Feb

04,
09,
04,
11,
11,
11,

1982
1982
1982
1987
1987
1987

DOPAMINE HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
XX
XX

INJECTABLE; INJECTION
DOPAMINE HYDROCHLORIDE
+ HOSPIRA
+
+
+
+ LUITPOLD
+
+
DOPAMINE HYDROCHLORIDE
+ B BRAUN
+
DOPAMINE HYDROCHLORIDE
+ B BRAUN
DOPAMINE HYDROCHLORIDE
+ BAXTER HLTHCARE
+
+
+ HOSPIRA
+
+
DOPAMINE HYDROCHLORIDE
+ B BRAUN
DOPAMINE HYDROCHLORIDE
+ BAXTER HLTHCARE

40MG/ML
80MG/100ML
80MG/ML
160MG/100ML
40MG/ML
80MG/ML
160MG/ML
AND DEXTROSE 5%
80MG/100ML
320MG/100ML
AND DEXTROSE 5% IN PLASTIC CONTAINER
160MG/100ML
IN DEXTROSE 5% IN PLASTIC CONTAINER
80MG/100ML
160MG/100ML
320MG/100ML
80MG/100ML
160MG/100ML
320MG/100ML
AND DEXTROSE 5% IN PLASTIC CONTAINER
40MG/100ML
IN DEXTROSE 5% IN PLASTIC CONTAINER
640MG/100ML

N019099 002
N019099 004

Oct 15, 1986

Oct 15, 1986

N019099 003

Oct 15, 1986

N019615
N019615
N019615
N018826
N018826
N018826

Mar
Mar
Mar
Sep
Sep
Sep

001
002
003
001
002
003

27,
27,
27,
30,
30,
30,

1987
1987
1987
1983
1983
1983

N019099 001

Oct 15, 1986

N019615 004

Mar 27, 1987

N022106 002
N022106 001

Oct 05, 2010

Oct 12, 2007

A078981
A078395
A090143
A077846
A079186
A078748
A078756

Apr
Oct
Jun
Oct
Nov
Nov
Dec

DORIPENEM
INJECTABLE; IV (INFUSION)
DORIBAX
JANSSEN PHARMS
250MG/VIAL
XX
XX +
500MG/VIAL

DORZOLAMIDE HYDROCHLORIDE

AT
AT
AT
AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
DORZOLAMIDE HYDROCHLORIDE
ALCON PHARMS LTD
EQ
APOTEX INC
EQ
BAUSCH AND LOMB
EQ
HI TECH PHARMA
EQ
LUITPOLD
EQ
SANDOZ
EQ
TEVA PHARMS
EQ

2%
2%
2%
2%
2%
2%
2%

BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
001
001
001
001
001
001

13,
28,
25,
28,
18,
06,
04,

2009
2008
2009
2008
2009
2008
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 147 (of 424)

DORZOLAMIDE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
TRUSOPT
AT + MERCK
EQ 2% BASE

N020408 001

Dec 09, 1994

N020869 001

Apr 07, 1998

A090604
A078201
A090037
A077847
A078749
A078704

Nov
Oct
Jul
Oct
Nov
Sep

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

AT
AT
AT
AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
COSOPT
+ MERCK
EQ 2%
DORZOLAMIDE HYDROCHLORIDE AND
ALCON RES
EQ 2%
APOTEX INC
EQ 2%
BAUSCH AND LOMB
EQ 2%
HI TECH PHARMA
EQ 2%
SANDOZ
EQ 2%
TEVA PARNTL
EQ 2%

BASE;EQ
TIMOLOL
BASE;EQ
BASE;EQ
BASE;EQ
BASE;EQ
BASE;EQ
BASE;EQ

0.5% BASE
MALEATE
0.5% BASE
0.5% BASE
0.5% BASE
0.5% BASE
0.5% BASE
0.5% BASE

001
001
001
001
001
001

18,
28,
14,
28,
06,
28,

2009
2008
2009
2008
2008
2009

DOXAPRAM HYDROCHLORIDE
INJECTABLE; INJECTION
DOPRAM
AP + BAXTER HLTHCARE
DOXAPRAM HYDROCHLORIDE
BEDFORD
AP
WATSON LABS
AP

20MG/ML

N014879 001

20MG/ML
20MG/ML

A076266 001
A073529 001

Jan 10, 2003

Jan 30, 1992

DOXAZOSIN MESYLATE
TABLET; ORAL
CARDURA
AB + PFIZER
AB
AB
AB
DOXAZOSIN MESYLATE
APOTEX
AB
AB
AB
AB
DAVA PHARMS INC
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
NESHER PHARMS
AB
AB
AB
AB
PLIVA
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
WATSON LABS
AB
AB
AB

EQ
EQ
EQ
EQ

1MG
2MG
4MG
8MG

BASE
BASE
BASE
BASE

N019668
N019668
N019668
N019668

001
002
003
004

Nov
Nov
Nov
Nov

02,
02,
02,
02,

1990
1990
1990
1990

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A075580
A075580
A075580
A075580
A076161
A076161
A076161
A076161
A075509
A075509
A075509
A075509
A075609
A075609
A075609
A075609
A075750
A075750
A075750
A075750
A075536
A075536
A075536
A075536
A075426
A075426
A075426

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003

Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Oct
Oct
Oct

18,
18,
18,
18,
10,
10,
10,
10,
19,
19,
19,
19,
18,
18,
18,
18,
08,
08,
08,
08,
18,
18,
18,
18,
18,
18,
18,

2000
2000
2000
2000
2004
2004
2004
2004
2000
2000
2000
2000
2000
2000
2000
2000
2001
2001
2001
2001
2000
2000
2000
2000
2000
2000
2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 148 (of 424)

DOXAZOSIN MESYLATE
TABLET; ORAL
DOXAZOSIN MESYLATE
WATSON LABS
AB

EQ 8MG BASE

A075426 004

Oct 18, 2000

TABLET, EXTENDED RELEASE; ORAL

CARDURA XL
PFIZER
EQ 4MG BASE
XX
EQ 8MG BASE
XX +

N021269 001
N021269 002

Feb 22, 2005

Feb 22, 2005

A070791
A070791
A070791
A070791
A070791
A071697
A071437
A071595
A071608
A071422
A071485
A071486
A071238
A071326
A071239

May
May
May
May
May
Nov
Nov
Nov
Nov
Nov
Apr
Apr
Apr
Apr
Apr

DOXEPIN HYDROCHLORIDE
CAPSULE; ORAL
DOXEPIN HYDROCHLORIDE
MYLAN
AB
AB
AB
AB
AB
PAR PHARM
AB
AB +
AB
AB
AB +
WATSON LABS
AB
AB
AB
AB
AB
DOXEPIN HYDROCHLORIDE
PAR PHARM
XX

AA
AA
AA
AA

CONCENTRATE; ORAL
DOXEPIN HYDROCHLORIDE
PHARM ASSOC
SILARX
+ TEVA PHARMS
WOCKHARDT

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

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

002
003
001
004
005
001
001
001
001
001
001
001
001
001
001

13,
13,
13,
13,
13,
09,
09,
09,
09,
09,
30,
30,
30,
30,
30,

1986
1986
1986
1986
1986
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987

EQ 150MG BASE

A071669 001

Nov 09, 1987

EQ
EQ
EQ
EQ

A075924
A074721
A071609
A071918

Jan
Dec
Nov
Jul

10MG
10MG
10MG
10MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML

001
001
001
001

15,
29,
09,
20,

2004
1998
1987
1988

CREAM; TOPICAL

ZONALON

XX + NYCOMED US

5%

N020126 001

Apr 01, 1994

TABLET; ORAL
SILENOR
SOMAXON
XX
XX +

EQ 3MG BASE
EQ 6MG BASE

N022036 001
N022036 002

Mar 17, 2010

Mar 17, 2010

0.5MCG

A091433 001

Sep 23, 2011

0.5MCG

N020862 002

Apr 23, 2004

1MCG
2.5MCG

N020862 003
N020862 001

Jul 13, 2009

Jun 09, 1999

2MCG/ML (2MCG/ML)
4MCG/2ML (2MCG/ML)

N021027 002
N021027 001

Apr 06, 2000

Apr 06, 2000

DOXERCALCIFEROL

AB
AB
XX
XX

CAPSULE; ORAL
DOXERCALCIFEROL
ROXANE
HECTOROL
GENZYME CORP
HECTOROL
GENZYME CORP
+

INJECTABLE; INJECTION
HECTOROL
GENZYME CORP
XX
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 149 (of 424)

DOXORUBICIN HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
DOXORUBICIN HYDROCHLORIDE
APP PHARMS
2MG/ML
+ BEDFORD
2MG/ML
+
10MG/VIAL
+
20MG/VIAL
+
50MG/VIAL
+
200MG/100ML
ONCO THERAPIES LTD
10MG/VIAL
50MG/VIAL
PHARMACHEMIE
2MG/ML
10MG/VIAL
20MG/VIAL
50MG/VIAL
200MG/100ML
TEVA PARENTERAL
2MG/ML
200MG/100ML

INJECTABLE, LIPOSOMAL; INJECTION

DOXIL

20MG/10ML (2MG/ML)
XX + ORTHO BIOTECH
50MG/25ML (2MG/ML)
XX +

A063277
A062975
A062921
A062921
A062921
A064097
A200170
A200170
A063336
A063097
A063097
A063097
A063336
A064140
A064140

001
001
001
002
003
001
001
002
001
001
002
003
004
001
002

Oct
Mar
Mar
Mar
Mar
Sep
Oct
Oct
Feb
May
May
May
Feb
Jul
Jul

26,
17,
17,
17,
17,
13,
28,
28,
28,
21,
21,
21,
28,
28,
28,

1995
1989
1989
1989
1989
1994
2011
2011
1995
1990
1990
1990
1995
1995
1995

N050718 001
N050718 002

Nov 17, 1995

Jun 13, 2000

EQ 150MG BASE
40MG
EQ 50MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE

A200065
A090855
A065055
A065055
A065055
A065053
A065053
A065053
A065032
A065032
A065041
A065041

Feb
Jul
Dec
Dec
Jul
Nov
Sep
Nov
Jun
Jun
Apr
Apr

EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE

N050641 002
N050641 003
N050641 001

Feb 10, 1992

Oct 18, 2006
Dec 29, 1989

40MG

N050805 001

May 26, 2006

EQ 25MG BASE/5ML

A065454 001

Jul 16, 2008

EQ 25MG BASE/5ML

N050006 001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A091605
A091605
A091605
A091605
A065285
A065285
A065285
A065285
A065377

DOXYCYCLINE
CAPSULE; ORAL
DOXYCYCLINE
IMPAX LABS INC
AB
MYLAN
AB
PAR PHARM
AB
AB
AB +
RANBAXY
AB
AB
AB
SANDOZ
AB
AB
WATSON LABS
AB
AB
MONODOX
WATSON PHARMS
AB
AB
AB +
ORACEA
AB + GALDERMA LABS LP
FOR SUSPENSION; ORAL
DOXYCYCLINE
IVAX SUB TEVA PHARMS
AB
VIBRAMYCIN
AB + PFIZER
TABLET; ORAL
DOXYCYCLINE
HERITAGE PHARMS INC
AB
AB
AB
AB
LANNETT
AB
AB
AB
AB
MYLAN
AB

50MG BASE
75MG BASE
100MG BASE
150MG BASE
50MG BASE
75MG BASE
100MG BASE
150MG BASE
50MG BASE

001
001
001
002
003
001
003
002
001
002
001
002

001
002
003
004
001
003
002
004
001

Dec
Dec
Dec
Dec
Dec
Jul
Dec
Jul
Nov

17,
01,
01,
01,
15,
22,
10,
22,
30,
30,
28,
28,

20,
20,
20,
20,
08,
30,
08,
30,
07,

2011
2010
2000
2000
2005
2000
2003
2000
2000
2000
2000
2000

2011
2011
2011
2011
2005
2008
2005
2008
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 150 (of 424)

DOXYCYCLINE
TABLET; ORAL
DOXYCYCLINE
MYLAN
AB
AB
AB
PAR PHARM
AB
AB
AB
AB +
RANBAXY
AB
AB
AB
SANDOZ
AB
AB
AB

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

75MG BASE
100MG BASE
150MG BASE
50MG BASE
75MG BASE
100MG BASE
150MG BASE
50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE

A065377
A065377
A065427
A065070
A065070
A065070
A065070
A065356
A065356
A065356
A065353
A065353
A065353

002
003
001
001
003
002
004
001
002
003
001
002
003

Nov
Nov
Jun
Dec
Dec
Dec
Jul
May
May
May
Nov
Nov
Nov

07,
07,
07,
15,
30,
15,
14,
31,
31,
31,
27,
27,
27,

2006
2006
2007
2000
2002
2000
2005
2006
2006
2006
2006
2006
2006

Sep
Sep
Jul
Jul
Oct

11,
11,
10,
10,
13,

1984
1984
1986
1986
1982

DOXYCYCLINE CALCIUM
SUSPENSION; ORAL

VIBRAMYCIN

XX + PFIZER

EQ 50MG BASE/5ML

N050480 001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A062500
A062500
A062675
A062676
A062031
A062031
A062396
A062396

DOXYCYCLINE HYCLATE
CAPSULE; ORAL
DOXYCYCLINE HYCLATE
IVAX SUB TEVA PHARMS
AB
AB
MUTUAL PHARM
AB
AB
WATSON LABS FLORIDA
AB
AB
WEST WARD
AB
AB
VIBRAMYCIN
PFIZER
AB
AB +
DOXYCYCLINE HYCLATE
XX + WEST WARD

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

Nov 07, 1984

May 07, 1984

EQ 50MG BASE
EQ 100MG BASE

N050007 001
N050007 002

EQ 20MG BASE

A065103 001

May 13, 2005

A065281 001
A065281 002

Dec 21, 2005

Dec 21, 2005

EQ 100MG BASE/VIAL

A062475 001

Dec 09, 1983

EQ 100MG BASE/VIAL

A062569 001

Mar 09, 1988

EQ 200MG BASE/VIAL

CAPSULE, DELAYED RELEASE; ORAL

DOXYCYCLINE HYCLATE
MEDICIS
EQ 75MG BASE
XX
EQ 100MG BASE
XX +
INJECTABLE; INJECTION
DOXY 100
AP + APP PHARMS
DOXYCYCLINE
AP + BEDFORD
DOXY 200
XX + APP PHARMS

001
002
001
001
002
001
002
001

A062475 002

Dec 09, 1983

SYSTEM, EXTENDED RELEASE; PERIODONTAL

ATRIDOX

50MG
XX + TOLMAR

N050751 001

Sep 03, 1998

TABLET; ORAL
DOXYCYCLINE HYCLATE
COREPHARMA
AB
IVAX SUB TEVA PHARMS
AB
AB
LANNETT
AB
MUTUAL PHARM
AB

A065182
A065163
A062505
A065277
A062677

May
May
Sep
Nov
Jul

EQ
EQ
EQ
EQ
EQ

20MG BASE
20MG BASE
100MG BASE
20MG BASE
100MG BASE

001
001
001
001
001

13,
13,
11,
10,
10,

2005
2005
1984
2005
1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 151 (of 424)

DOXYCYCLINE HYCLATE

AB
AB
AB
AB
AB

TABLET; ORAL
DOXYCYCLINE HYCLATE
MUTUAL PHARMA
VINTAGE PHARMS
WATSON LABS
+ WEST-WARD PHARM CORP
PERIOSTAT
+ GALDERMA LABS LP

EQ
EQ
EQ
EQ

20MG BASE
100MG BASE
100MG BASE
100MG BASE

EQ 20MG BASE

TABLET, DELAYED RELEASE; ORAL

DORYX
MAYNE PHARMA
AB
EQ 75MG BASE
AB
EQ 100MG BASE
DOXYCYCLINE HYCLATE
ACTAVIS ELIZABETH
AB
EQ 75MG BASE
AB
EQ 100MG BASE
IMPAX LABS INC
AB
EQ 75MG BASE
AB
EQ 100MG BASE
MYLAN
AB
EQ 75MG BASE
AB
EQ 100MG BASE
DORYX
EQ 150MG BASE
XX + MAYNE PHARMA

A065134
A062538
A062421
A065095

001
001
001
001

May
Apr
Feb
Jul

13,
07,
02,
02,

2005
1986
1983
2003

N050783 001

Feb 02, 2001

N050795 001
N050795 002

May 06, 2005

May 06, 2005

A090134
A090134
A090505
A090505
A090431
A090431

Dec
Dec
Dec
Dec
Dec
Dec

001
002
001
002
001
002

14,
14,
28,
28,
28,
28,

2011
2011
2010
2010
2010
2010

N050795 003

Jun 20, 2008

2.5MG
5MG
10MG
2.5MG
5MG
10MG

A078501
A078501
A078501
A078292
A078292
A078292

Aug
Aug
Aug
Jun
Jun
Jun

2.5MG
5MG
10MG

N018651 001
N018651 002
N018651 003

May 31, 1985

May 31, 1985
May 31, 1985

EQ 400MG BASE

N022425 001

Jul 01, 2009

2.5MG/ML
2.5MG/ML

A071981 001
A072123 001

Feb 29, 1988

Oct 24, 1988

2.5MG/ML

N016796 001

0.5MG;1MG

N021355 002

Sep 28, 2005

A078515 001

Mar 30, 2009

DRONABINOL
CAPSULE; ORAL
DRONABINOL
INSYS THERAP
AB
AB
AB
SVC PHARMA
AB
AB
AB
MARINOL
ABBOTT PRODS
AB
AB +
AB

001
002
003
001
002
003

19,
19,
19,
27,
27,
27,

2011
2011
2011
2008
2008
2008

DRONEDARONE HYDROCHLORIDE
TABLET; ORAL

MULTAQ

XX + SANOFI AVENTIS US

DROPERIDOL
INJECTABLE; INJECTION
DROPERIDOL
HOSPIRA
AP
LUITPOLD
AP
INAPSINE
AP + AKORN INC

DROSPIRENONE; ESTRADIOL
TABLET; ORAL

ANGELIQ

XX + BAYER HLTHCARE

DROSPIRENONE; ETHINYL ESTRADIOL

TABLET; ORAL
DROSPIRENONE AND ETHINYL ESTRADIOL
BARR
AB
3MG;0.02MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 152 (of 424)

DROSPIRENONE; ETHINYL ESTRADIOL

TABLET; ORAL
DROSPIRENONE AND ETHINYL ESTRADIOL
WATSON LABS
AB
3MG;0.02MG
LORYNA
SANDOZ
AB
3MG;0.02MG
YAZ
AB + BAYER HLTHCARE
3MG;0.02MG

AB
AB
AB
AB

A078833 001

Nov 28, 2011

A079221 001

Mar 28, 2011

N021676 001

Mar 16, 2006

A077527 001
A090081 001

May 09, 2008

Sep 07, 2010

A090114 001

Mar 28, 2011

N021098 001

May 11, 2001

3MG,N/A;0.02MG,N/A;0.451MG,0.451MG

N022532 001

Sep 24, 2010

3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

N022574 001

Dec 16, 2010

N021427 001
N021427 002
N021427 004

Aug 03, 2004

Aug 03, 2004
Aug 03, 2004

0.5MG

N021319 001

Nov 20, 2001

0.5MG

A090095 001

Dec 21, 2010

0.5MG;0.4MG

N022460 001

Jun 14, 2010

200MG
400MG

A084566 001

A084566 002

0.125%

N011963 001

1%
1%

A076075 001
A076479 001

TABLET; ORAL-28
DROSPIRENONE AND ETHINYL ESTRADIOL
BARR
3MG;0.03MG
WATSON LABS
3MG;0.03MG
SYEDA
SANDOZ
3MG;0.03MG
YASMIN
+ BAYER HLTHCARE
3MG;0.03MG

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

TABLET; ORAL

BEYAZ

XX + BAYER HLTHCARE
SAFYRAL
BAYER HLTHCARE
XX

DULOXETINE HYDROCHLORIDE
CAPSULE, DELAYED REL PELLETS; ORAL
CYMBALTA
LILLY
EQ 20MG BASE
XX
EQ 30MG BASE
XX
EQ 60MG BASE
XX +

DUTASTERIDE
CAPSULE; ORAL
AVODART
AB + GLAXOSMITHKLINE
DUTASTERIDE
BARR
AB

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

CAPSULE; ORAL

JALYN

XX + GLAXOSMITHKLINE

DYPHYLLINE
TABLET; ORAL

LUFYLLIN

MEDA PHARMS
XX
XX +

ECHOTHIOPHATE IODIDE
FOR SOLUTION; OPHTHALMIC

PHOSPHOLINE IODIDE

XX + WYETH PHARMS INC

ECONAZOLE NITRATE
CREAM; TOPICAL
ECONAZOLE NITRATE
AB + ALTANA
PERRIGO NEW YORK
AB

Nov 26, 2002

Jun 23, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 153 (of 424)

ECONAZOLE NITRATE
CREAM; TOPICAL
ECONAZOLE NITRATE
PRASCO
AB
TARO
AB

1%
1%

A076574 001
A076005 001

Dec 17, 2004

Nov 26, 2002

EDETATE CALCIUM DISODIUM

INJECTABLE; INJECTION

CALCIUM DISODIUM VERSENATE

200MG/ML
XX + MEDICIS

N008922 001

EDROPHONIUM CHLORIDE
INJECTABLE; INJECTION
ENLON
BIONICHE PHARMA
AP
10MG/ML
TENSILON
AP + VALEANT PHARM INTL
10MG/ML

TENSILON PRESERVATIVE FREE

AP + VALEANT PHARM INTL

10MG/ML

A088873 001

Aug 06, 1985

N007959 001
N007959 002

EFAVIRENZ
CAPSULE; ORAL

SUSTIVA

BRISTOL MYERS SQUIBB

XX
XX +

50MG

200MG

N020972 001
N020972 003

Sep 17, 1998

Sep 17, 1998

TABLET; ORAL

SUSTIVA

XX + BRISTOL MYERS SQUIBB 600MG

N021360 002

Feb 01, 2002

N021937 001

Jul 12, 2006

13.9%

N021145 001

Jul 27, 2000

EQ 20MG BASE

EQ 40MG BASE

N021016 001
N021016 002

Dec 26, 2002

Dec 26, 2002

N022291
N022291
N022291
N022291

Oct
Nov
Nov
Sep

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET; ORAL

ATRIPLA

XX + GILEAD

600MG;200MG;300MG

EFLORNITHINE HYDROCHLORIDE
CREAM; TOPICAL

VANIQA

XX + SKINMEDICA

ELETRIPTAN HYDROBROMIDE
TABLET; ORAL

RELPAX

PFIZER IRELAND
XX
XX +

ELTROMBOPAG OLAMINE
TABLET; ORAL

PROMACTA

GLAXOSMITHKLINE
XX
XX
XX +
XX

EQ
EQ
EQ
EQ

12.5MG ACID

25MG ACID

50MG ACID

75MG ACID

004
001
002
003

20,
20,
20,
08,

2011
2008
2008
2009

EMEDASTINE DIFUMARATE
SOLUTION/DROPS; OPHTHALMIC

EMADINE

XX + ALCON
0.05%

N020706 001

Dec 29, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 154 (of 424)

EMTRICITABINE
CAPSULE; ORAL

EMTRIVA

XX + GILEAD

200MG

N021500 001

Jul 02, 2003

SOLUTION; ORAL

EMTRIVA

XX + GILEAD

10MG/ML

N021896 001

Sep 28, 2005

N202123 001

Aug 10, 2011

200MG;300MG

N021752 001

Aug 02, 2004

2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
2.5MG
2.5MG
5MG
5MG
10MG
10MG
20MG
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

A075178
A075178
A075178
A075178
A075496
A075496
A075459
A075459
A075472
A075480
A075472
A075480
A075472
A075480
A075472
A075480
A075621
A075621
A075621
A075621
A075657
A075657
A075657
A075657
A075479
A075479
A075479
A075479
A075501
A075501
A075501
A075501
A075483
A075483
A075483
A075483

Mar
Mar
Mar
Mar
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Jan
Jan
Jan
Jan
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug

2.5MG
5MG

N018998 005
N018998 001

EMTRICITABINE; RILPIVIRINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET; ORAL

COMPLERA

XX + GILEAD SCIENCES INC

200MG;25MG;300MG

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET; ORAL

TRUVADA

XX + GILEAD

ENALAPRIL MALEATE
TABLET; ORAL
ENALAPRIL MALEATE
APOTEX
AB
AB
AB
AB
LEK PHARMS
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
AB
AB
SANDOZ
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
AB
VASOTEC
VALEANT INTL
AB
AB

002
001
003
004
001
002
001
002
001
001
002
002
003
003
004
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

23,
23,
23,
23,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
23,
23,
23,
23,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,

2001
2001
2001
2001
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2001
2001
2001
2001
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000

Jul 26, 1988

Dec 24, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 155 (of 424)

ENALAPRIL MALEATE
TABLET; ORAL
VASOTEC
VALEANT INTL
AB
AB +

10MG
20MG

N018998 002
N018998 003

Dec 24, 1985

Dec 24, 1985

A076486
A076486
A075909
A075909
A075624
A075624
A076116
A076116
A075788
A075788
A075727
A075727

Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
APOTEX INC
5MG;12.5MG
AB
10MG;25MG
AB
DR REDDYS LABS LTD
5MG;12.5MG
AB
10MG;25MG
AB
MYLAN
5MG;12.5MG
AB
10MG;25MG
AB
SANDOZ
5MG;12.5MG
AB
10MG;25MG
AB
TARO PHARM INDS
5MG;12.5MG
AB
10MG;25MG
AB
TEVA
5MG;12.5MG
AB
10MG;25MG
AB
VASERETIC
VALEANT INTL
AB
5MG;12.5MG
AB +
10MG;25MG

001
002
001
002
001
002
001
002
001
002
001
002

27,
27,
15,
15,
18,
18,
19,
19,
18,
18,
18,
18,

2004
2004
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001

N019221 003
N019221 001

Jul 12, 1995

Oct 31, 1986

1.25MG/ML
1.25MG/ML
1.25MG/ML
1.25MG/ML

A075634
A078687
A075458
A075578

Aug
Dec
Aug
Aug

99.9%

A074396 001

99.9%

N017087 001

90MG/VIAL

N021481 001

Mar 13, 2003

A078660 001

Nov 28, 2011

N020164 009

Jan 23, 2003

A076684
A076684
A076684
A076684
A076684
A076684

Sep
Sep
Sep
Sep
Sep
Sep

ENALAPRILAT

AP
AP
AP
AP

INJECTABLE; INJECTION
ENALAPRILAT
+ BEDFORD
HIKMA FARMACEUTICA
+ HOSPIRA
TEVA PARENTERAL

001
001
001
001

22,
23,
22,
22,

2000
2008
2000
2000

ENFLURANE
LIQUID; INHALATION
ENFLURANE
PIRAMAL CRITICAL
AN
ETHRANE
AN + BAXTER HLTHCARE CORP

Jul 29, 1994

ENFUVIRTIDE
INJECTABLE; SUBCUTANEOUS

FUZEON

XX + ROCHE

ENOXAPARIN SODIUM
INJECTABLE; INTRAVENOUS, SUBCUTANEOUS
ENOXAPARIN SODIUM
SANDOZ INC
AB
300MG/3ML (100MG/ML)
LOVENOX
SANOFI AVENTIS US
AB
300MG/3ML (100MG/ML)

AP
AP
AP
AP
AP
AP

INJECTABLE; SUBCUTANEOUS
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
AMPHASTAR PHARM
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)

001
002
003
004
005
006

19,
19,
19,
19,
19,
19,

2011
2011
2011
2011
2011
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 156 (of 424)

ENOXAPARIN SODIUM

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; SUBCUTANEOUS
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
AMPHASTAR PHARM
150MG/ML (150MG/ML)
SANDOZ
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)
LOVENOX (PRESERVATIVE FREE)
SANOFI AVENTIS US
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)

A076684
A077857
A077857
A077857
A077857
A077857
A077857
A077857

007
002
003
004
005
001
006
007

Sep
Jul
Jul
Jul
Jul
Jul
Jul
Jul

19,
23,
23,
23,
23,
23,
23,
23,

2011
2010
2010
2010
2010
2010
2010
2010

N020164
N020164
N020164
N020164
N020164
N020164
N020164

001
002
003
004
005
007
008

Mar
Jan
Mar
Mar
Mar
Jun
Jun

29,
30,
27,
27,
27,
02,
02,

1993
1998
1998
1998
1998
2000
2000

ENTACAPONE
TABLET; ORAL

COMTAN

XX + ORION

200MG

N020796 001

Oct 19, 1999

SOLUTION; ORAL

BARACLUDE

XX + BRISTOL MYERS SQUIBB

0.05MG/ML

N021798 001

Mar 29, 2005

TABLET; ORAL
BARACLUDE
BRISTOL MYERS SQUIBB
XX
XX +

0.5MG
1MG

N021797 001
N021797 002

Mar 29, 2005

Mar 29, 2005

N021565 001

Oct 16, 2003

A090919
A090870
A090951
A091626

Oct
Mar
Oct
Oct

ENTECAVIR

EPINASTINE HYDROCHLORIDE

AT
AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
ELESTAT
+ ALLERGAN
0.05%
EPINASTINE HYDROCHLORIDE
APOTEX
0.05%
CYPRESS PHARM
0.05%
PHARMAFORCE
0.05%
SUN PHARM INDS
0.05%

001
001
001
001

31,
14,
31,
31,

2011
2011
2011
2011

EPINEPHRINE

BX
BX
BX
BX

INJECTABLE; IM-SC
ADRENACLICK
+ SHIONOGI INC
+
TWINJECT 0.15
+ SHIONOGI INC
TWINJECT 0.3
+ SHIONOGI INC

EQ 0.15MG /DELIVERY
EQ 0.3MG /DELIVERY

N020800 003
N020800 004

Nov 25, 2009

Nov 25, 2009

EQ 0.15MG /DELIVERY

N020800 002

May 28, 2004

EQ 0.3MG /DELIVERY

N020800 001

May 30, 2003

N019430 001

Dec 22, 1987

N019430 002

Dec 22, 1987

INJECTABLE; INTRAMUSCULAR
EPIPEN
BX + MERIDIAN MEDCL TECHN 0.3MG/DELIVERY
EPIPEN JR.
BX + MERIDIAN MEDCL TECHN 0.15MG/DELIVERY

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PRESCRIPTION DRUG PRODUCT LIST

3 - 157 (of 424)

EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION

LIGNOSPAN FORTE

XX + DEPROCO
LIGNOSPAN STANDARD
XX + DEPROCO

EQ 0.02MG BASE/ML;2%

A088389 001

Jan 22, 1985

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%
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
SEPTODONT INC
AP
0.005MG/ML;4%

N021383 001
A078959 001

Aug 30, 2011

A040057
A040057
A089635
A088571
A089645
A089651
A089644
A078772
A089646
A078772

Feb
Feb
Jun
Sep
Jun
Jun
Jun
May
Jun
May

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
EASTMAN KODAK
0.01MG/ML;2%
AP
0.02MG/ML;2%
AP
HOSPIRA
0.005MG/ML;0.5%
AP
0.005MG/ML;1.5%
AP
0.005MG/ML;1.5%
AP
0.005MG/ML;2%
AP
0.01MG/ML;1%
AP
0.01MG/ML;2%
AP
0.01MG/ML;2%
AP
0.02MG/ML;2%
AP
OCTOCAINE
SEPTODONT
AP
0.01MG/ML;2%
AP +
0.02MG/ML;2%
XYLOCAINE DENTAL WITH EPINEPHRINE
0.01MG/ML;2%
AP + DENTSPLY PHARM
0.02MG/ML;2%
AP +
XYLOCAINE W/ EPINEPHRINE
0.005MG/ML;0.5%
AP + APP PHARMS
0.005MG/ML;1%
AP +
0.005MG/ML;1.5%
AP +
0.005MG/ML;2%
AP +
0.01MG/ML;1%
AP +
0.02MG/ML;2%
AP +

002
001
001
001
001
001
001
001
001
002

26,
26,
21,
13,
21,
21,
21,
12,
21,
12,

1993
1993
1988
1985
1988
1988
1988
2008
1988
2008

A084048 001
A084048 002
N021381 001
N021381 002
N006488
N006488
N006488
N006488
N006488
N006488

012
018
017
019
004
005

Nov 13, 1986

Nov 13, 1986

EPIRUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
ELLENCE
200MG/100ML (2MG/ML)
AP + PFIZER INC
AP
50MG/25ML (2MG/ML)
EPIRUBICIN HYDROCHLORIDE
ACTAVIS TOTOWA
10MG/5ML (2MG/ML)
AP
50MG/25ML (2MG/ML)
AP
200MG/100ML (2MG/ML)
AP
AKORN INC
50MG/25ML (2MG/ML)
AP
APP PHARMS
10MG/5ML (2MG/ML)
AP
150MG/75ML (2MG/ML)
AP
200MG/100ML (2MG/ML)
AP
50MG/25ML (2MG/ML)
AP
BEDFORD
200MG/100ML (2MG/ML)
AP
50MG/25ML (2MG/ML)
AP
BIONICHE PHARMA USA
50MG/25ML (2MG/ML)
AP
200MG/100ML (2MG/ML)
AP
EBEWE PHARMA
50MG/25ML (2MG/ML)
AP

N050778 001
N050778 002
A065445
A065445
A065445
A090163
A065408
A065408
A065408
A065408
A065289
A065289
A065371
A065371
A065339

001
002
003
001
001
003
004
002
002
001
001
002
001

Sep 15, 1999

Sep 15, 1999
Sep
Sep
Sep
Jun
Oct
Oct
Oct
Oct
Jun
Jun
Nov
Nov
Dec

18,
18,
18,
24,
15,
15,
15,
15,
27,
27,
28,
28,
22,

2008
2008
2008
2009
2007
2007
2007
2007
2007
2007
2007
2007
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 158 (of 424)

EPIRUBICIN HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
EPIRUBICIN HYDROCHLORIDE
EBEWE PHARMA
200MG/100ML (2MG/ML)
FRESENIUS KABI ONCOL 200MG/100ML (2MG/ML)
50MG/25ML (2MG/ML)
HOSPIRA
200MG/100ML (2MG/ML)
50MG/25ML (2MG/ML)
10MG/5ML (2MG/ML)
150MG/75ML (2MG/ML)
MUSTAFA NEVSAT
200MG/100ML (2MG/ML)
50MG/25ML (2MG/ML)
TEVA PARENTERAL
50MG/25ML (2MG/ML)
200MG/100ML (2MG/ML)
WATSON LABS
200MG/100ML (2MG/ML)
50MG/25ML (2MG/ML)
X GEN PHARMS
50MG/25ML (2MG/ML)
200MG/100ML (2MG/ML)

INJECTABLE; IV (INFUSION)

EPIRUBICIN HYDROCHLORIDE

50MG/VIAL
XX + HOSPIRA

A065339
A065411
A065411
A065343
A065343
A065343
A065343
A090266
A090266
A065331
A065331
A065361
A065361
A090075
A090075

002
001
002
004
002
001
003
002
001
001
002
002
001
001
002

Dec
Aug
Aug
Apr
Apr
Apr
Apr
Apr
Apr
Aug
Aug
Oct
Oct
Mar
Mar

22,
20,
20,
19,
19,
19,
19,
15,
15,
09,
09,
22,
22,
25,
25,

2009
2007
2007
2007
2007
2007
2007
2011
2011
2007
2007
2007
2007
2010
2010

N050807 001

Sep 15, 2006

25MG
50MG
25MG
50MG

A078482
A078482
A078510
A078510

Jul
Jul
Aug
Aug

25MG
50MG

N021437 001
N021437 002

Sep 27, 2002

Sep 27, 2002

EQ 0.5MG BASE/VIAL
EQ 1.5MG BASE/VIAL

A078396 001
A078396 002

Apr 23, 2008

Apr 23, 2008

EQ 0.5MG BASE/VIAL
EQ 1.5MG BASE/VIAL

N020444 001
N020444 002

Sep 20, 1995

Sep 20, 1995

EQ 1.5MG BASE/VIAL

N022260 001

Jun 27, 2008

EQ 400MG BASE
EQ 600MG BASE

A202012 001
A202012 002

Nov 16, 2011

Nov 16, 2011

EQ 400MG BASE
EQ 600MG BASE

N020738 005
N020738 006

Dec 22, 1997

May 27, 1999

N021268 001
N021268 002

Nov 01, 2001

Nov 01, 2001

EPLERENONE
TABLET; ORAL
EPLERENONE
APOTEX
AB
AB
SANDOZ
AB
AB
INSPRA
GD SEARLE LLC
AB
AB +

001
002
001
002

30,
30,
01,
01,

2008
2008
2008
2008

EPOPROSTENOL SODIUM
INJECTABLE; INJECTION
EPOPROSTENOL SODIUM
TEVA PARENTERAL
AP
AP
FLOLAN
AP + GLAXOSMITHKLINE LLC
AP +
VELETRI
XX + ACTELION

EPROSARTAN MESYLATE
TABLET; ORAL
EPROSARTAN MESYLATE
MYLAN PHARMS INC
AB
AB
TEVETEN
ABBOTT
AB
AB +

EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
TEVETEN HCT
ABBOTT
XX
XX +

600MG;12.5MG
600MG;25MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 159 (of 424)

EPTIFIBATIDE
INJECTABLE; INJECTION

INTEGRILIN

XX + SCHERING
XX +

2MG/ML
75MG/100ML

N020718 001
N020718 002

50,000 IU

N003444 001

50,000
50,000
50,000
50,000

A040833
A091004
A090455
A040865

May 18, 1998

May 18, 1998

ERGOCALCIFEROL

AA
AA
AA
AA
AA
AA

CAPSULE; ORAL
DRISDOL
+ SANOFI AVENTIS US
ERGOCALCIFEROL
ORIT LABS LLC
SIGMAPHARM LABS LLC
STRIDES ARCOLAB LTD
SUN PHARM INDS INC
VITAMIN D
BANNER PHARMACAPS

IU
IU
IU
IU

001
001
001
001

50,000 IU

A080704 001

May
Jul
Aug
Dec

20,
14,
03,
29,

2009
2010
2010
2009

ERGOLOID MESYLATES
TABLET; ORAL
ERGOLOID MESYLATES
MUTUAL PHARM
AB
HYDERGINE
AB + NOVARTIS

1MG

A081113 001

1MG

N017993 001

TABLET; SUBLINGUAL

ERGOLOID MESYLATES

WATSON LABS
XX

0.5MG

A087233 001

2MG

A087693 001

Feb 24, 1983

1MG/2ML (0.5MG/ML)

N201532 001

Nov 15, 2010

EQ 25MG BASE
EQ 100MG BASE
EQ 150MG BASE

N021743 001
N021743 002
N021743 003

Nov 18, 2004

Nov 18, 2004
Nov 18, 2004

N021337 001

Nov 21, 2001

Oct 31, 1991

ERGOTAMINE TARTRATE
TABLET; SUBLINGUAL

ERGOMAR

XX + ROSEDALE THERAPEUTIC

ERIBULIN MESYLATE
SOLUTION; INTRAVENOUS

HALAVEN

XX + EISAI INC

ERLOTINIB HYDROCHLORIDE
TABLET; ORAL
TARCEVA
OSI PHARMS
XX
XX
XX +

ERTAPENEM SODIUM
INJECTABLE; INTRAMUSCULAR, IV (INFUSION)

INVANZ

XX + MERCK
EQ 1GM BASE/VIAL

ERYTHROMYCIN
CAPSULE, DELAYED REL PELLETS; ORAL
ERYC
AB + HOSPIRA
250MG
WARNER CHILCOTT
AB
250MG
ERYTHROMYCIN
ARBOR PHARMS INC
AB
250MG

N050536 001
A062338 001
A062746 001

Dec 22, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 160 (of 424)

ERYTHROMYCIN
GEL; TOPICAL
E-GLADES
COREPHARMA
ERYGEL
+ MERZ PHARMS
ERYTHROMYCIN
ALTANA
PERRIGO

2%

A065009 001

Mar 18, 2002

2%

N050617 001

Oct 21, 1987

2%
2%

A064184 001
A063211 001

Sep 30, 1997

Jan 29, 1993

OINTMENT; OPHTHALMIC
ERYTHROMYCIN
AKORN
AT
BAUSCH AND LOMB
AT
AT + FERA PHARMS

0.5%
0.5%
0.5%

A064030 001
A064067 001
A062447 001

Jul 18, 1996

Jul 29, 1994
Sep 26, 1983

OINTMENT; TOPICAL

AKNE-MYCIN

XX + DOW PHARM SCIENCES

2%

N050584 001

Jan 10, 1985

2%

A062687 001

Feb 05, 1988

2%
2%
2%

A064187 001
A063038 001
A062825 001

Sep 30, 1997

Jan 11, 1991
Oct 23, 1987

2%

A064101 001

Oct 22, 1996

SWAB; TOPICAL
ERYTHROMYCIN
AT + ALTANA
AT + PERRIGO
VERSAPHARM
AT

2%
2%
2%

A065320 001
A064126 001
A090215 001

Jul 25, 2006

Jul 03, 1996
May 12, 2010

TABLET; ORAL

ERYTHROMYCIN

ARBOR PHARMS INC

XX
XX +

250MG
500MG

A061621 001

A061621 002

TABLET, COATED PARTICLES; ORAL

PCE
ARBOR PHARMS INC
333MG
XX
500MG
XX +

N050611 001
N050611 002

Sep 09, 1986

Aug 22, 1990

TABLET, DELAYED RELEASE; ORAL

ERY-TAB

250MG
XX + ARBOR PHARMS INC
333MG
XX +
500MG
XX +

A062298 001
A062298 003
A062298 002

Mar 29, 1982

AT
AT
AT
AT

AT
AT
AT
AT
AT

SOLUTION; TOPICAL
ERYTHRA-DERM
PADDOCK LLC
ERYTHROMYCIN
+ FOUGERA PHARMS
PERRIGO NEW YORK
WOCKHARDT
ERYTHRO-STATIN
HI TECH PHARMA

ERYTHROMYCIN ETHYLSUCCINATE
GRANULE; ORAL
E.E.S.
ARBOR PHARMS INC
AB
ERYPED
ARBOR PHARMS INC
AB
ERYPED
XX + ARBOR PHARMS INC
SUSPENSION; ORAL
E.E.S. 200
ARBOR PHARMS INC
AB
E.E.S. 400
AB + ARBOR PHARMS INC

EQ 200MG BASE/5ML

N050207 001

EQ 200MG BASE/5ML

N050207 003

EQ 400MG BASE/5ML

N050207 002

EQ 200MG BASE/5ML

A061639 001

EQ 400MG BASE/5ML

A061639 002

Mar 30, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 161 (of 424)

ERYTHROMYCIN ETHYLSUCCINATE
SUSPENSION; ORAL
PEDIAMYCIN
ARBOR PHARMS INC
AB
PEDIAMYCIN 400
ARBOR PHARMS INC
AB

EQ 200MG BASE/5ML

A062304 001

EQ 400MG BASE/5ML

A062304 002

TABLET; ORAL
E.E.S. 400
BX + ARBOR PHARMS INC
EQ 400MG BASE
ERYTHROMYCIN ETHYLSUCCINATE
BX + ARBOR PHARMS INC
EQ 400MG BASE

A061905 002

Aug 12, 1982

A061904 001

ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL

GRANULE; ORAL

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL

EQ 200MG BASE/5ML;EQ 600MG BASE/5ML

XX + BARR

A062759 001

May 20, 1988

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

A062638 001
N050609 001
A062638 002

Oct 31, 1986

Sep 24, 1986
Oct 31, 1986

EQ 250MG BASE

A060359 001

SOLUTION; ORAL

LEXAPRO

XX + FOREST LABS

EQ 5MG BASE/5ML

N021365 001

Nov 27, 2002

TABLET; ORAL
LEXAPRO
FOREST LABS
XX
XX
XX +

EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE

N021323 001
N021323 002
N021323 003

Aug 14, 2002

Aug 14, 2002
Aug 14, 2002

N019386 006

Feb 25, 2003

A076573 001
A076323 001
A076474 001

May 02, 2005

Aug 10, 2004
May 02, 2005

N019386 005

Jan 27, 2003

N019386 004

Feb 16, 2001

N021153 001
N021153 002

Feb 20, 2001

Feb 20, 2001

ERYTHROMYCIN LACTOBIONATE
INJECTABLE; INJECTION
ERYTHROCIN
HOSPIRA
AP
AP +
AP +

ERYTHROMYCIN STEARATE
TABLET; ORAL

ERYTHROCIN STEARATE

XX + ARBOR PHARMS INC

ESCITALOPRAM OXALATE

ESMOLOL HYDROCHLORIDE

AP
AP
AP
AP
XX
XX

INJECTABLE; INJECTION
BREVIBLOC
+ BAXTER HLTHCARE CORP 10MG/ML
ESMOLOL HYDROCHLORIDE
APP PHARMS
10MG/ML
BEDFORD LABS
10MG/ML
BIONICHE PHARMA
10MG/ML
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
+ BAXTER HLTHCARE CORP 2GM/100ML
BREVIBLOC IN PLASTIC CONTAINER
+ BAXTER HLTHCARE CORP 1GM/100ML

ESOMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED REL PELLETS; ORAL
NEXIUM
ASTRAZENECA
EQ 20MG BASE
XX
EQ 40MG BASE
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 162 (of 424)

ESOMEPRAZOLE MAGNESIUM
FOR SUSPENSION, DELAYED RELEASE; ORAL
NEXIUM
ASTRAZENECA
EQ 10MG BASE/PACKET
XX
EQ 20MG BASE/PACKET
XX
EQ 40MG BASE/PACKET
XX +

N022101 001
N021957 001
N021957 002

Feb 27, 2008

Oct 20, 2006
Oct 20, 2006

N022511 002
N022511 001

Apr 30, 2010

Apr 30, 2010

EQ 20MG BASE/VIAL
EQ 40MG BASE/VIAL

N021689 001
N021689 002

Mar 31, 2005

Mar 31, 2005

1MG
2MG
1MG
2MG
1MG
2MG

A074826
A074826
A074921
A074921
A074818
A074818

Jul
Jul
Jul
Jul
Aug
Aug

0.01%

A086069 001

Jan 31, 1984

N020375 005
N020375 006

May 27, 2003

May 27, 2003

A075182 004
A075182 005

Jul 20, 2006

Jul 20, 2006

N020323 002
N020323 004

Oct 28, 1994

Oct 28, 1994

N020538 006
N020538 008

Jan 08, 1999

Jan 08, 1999

N020375
N020375
N020375
N020375

004
001
003
002

Mar
Dec
Mar
Dec

05,
22,
23,
22,

1999
1994
1998
1994

A075182
A075182
A075182
A075182

003
006
002
001

Jan
Feb
Jan
Feb

26,
24,
26,
24,

2005
2000
2005
2000

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

TABLET, DELAYED RELEASE; ORAL
VIMOVO
ASTRAZENECA LP
EQ 20MG BASE;375MG
XX
EQ 20MG BASE;500MG
XX +

ESOMEPRAZOLE SODIUM
INJECTABLE; INTRAVENOUS

NEXIUM IV

XX + ASTRAZENECA
XX +

ESTAZOLAM
TABLET; ORAL
ESTAZOLAM
PAR PHARM
AB
AB
TEVA
AB
AB +
WATSON LABS
AB
AB

001
002
001
002
001
002

03,
03,
10,
10,
19,
19,

1997
1997
1997
1997
1997
1997

ESTRADIOL
CREAM; VAGINAL

ESTRACE

XX + WARNER CHILCOTT

FILM, EXTENDED RELEASE; TRANSDERMAL

CLIMARA
BAYER HLTHCARE
AB
0.0375MG/24HR
AB
0.06MG/24HR
ESTRADIOL
MYLAN TECHNOLOGIES
AB
0.0375MG/24HR
AB
0.06MG/24HR
VIVELLE
NOVARTIS
AB1
0.05MG/24HR
AB1
0.1MG/24HR
VIVELLE-DOT
NOVARTIS
AB1
0.05MG/24HR
AB1 +
0.1MG/24HR
CLIMARA
BAYER HLTHCARE
AB2
0.025MG/24HR
AB2
0.05MG/24HR
AB2
0.075MG/24HR
AB2 +
0.1MG/24HR
ESTRADIOL
MYLAN TECHNOLOGIES
AB2
0.025MG/24HR
AB2
0.05MG/24HR
AB2
0.075MG/24HR
AB2
0.1MG/24HR
ALORA
BX
WATSON LABS
0.025MG/24HR
BX
0.05MG/24HR
BX
0.075MG/24HR

N020655 004
N020655 001
N020655 002

Apr 05, 2002

Dec 20, 1996
Dec 20, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 163 (of 424)

ESTRADIOL

BX

FILM, EXTENDED RELEASE; TRANSDERMAL

ALORA
WATSON LABS
0.1MG/24HR
ESTRADERM
NOVARTIS
0.05MG/24HR
+
0.1MG/24HR
VIVELLE-DOT
NOVARTIS
0.025MG/24HR
0.0375MG/24HR
0.075MG/24HR
MENOSTAR
+ BAYER HLTHCARE
0.014MG/24HR

N020655 003

Dec 20, 1996

N019081 002
N019081 003

Sep 10, 1986

Sep 10, 1986

N020538 009
N020538 005
N020538 007

May 03, 2002

Jan 08, 1999
Jan 08, 1999

N021674 001

Jun 08, 2004

N022038 002
N022038 001
N022038 003

Jun 04, 2007

Jun 04, 2007
Jun 04, 2007

N021813 001

Dec 15, 2006

N021166 002

Feb 09, 2004

INSERT, EXTENDED RELEASE; VAGINAL

ESTRING

XX + PHARMACIA AND UPJOHN 0.0075MG/24HR

N020472 001

Apr 26, 1996

SPRAY; TRANSDERMAL

EVAMIST

XX + KV PHARM

1.53MG/SPRAY

N022014 001

Jul 27, 2007

BX
BX
BX
BX
BX
XX

GEL; TRANSDERMAL
DIVIGEL
UPSHER SMITH
XX
XX
XX +

0.1% (0.5GM/PACKET)
0.1% (0.25GM/PACKET)
0.1% (1GM/PACKET)

GEL, METERED; TRANSDERMAL

ELESTRIN

0.06% (0.87GM/ACTIVATION)
XX + AZUR PHARMA II
ESTROGEL
0.06% (1.25GM/ACTIVATION)
XX + ASCEND

TABLET; ORAL
ESTRACE
BRISTOL MYERS SQUIBB
AB
AB +
ESTRADIOL
BARR
AB
AB
AB
MYLAN
AB
AB
AB
USL PHARMA
AB
AB
AB
WATSON LABS
AB
AB
AB

1MG
2MG

A084499 001
A084500 001

0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG

A040197
A040197
A040197
A040326
A040326
A040326
A040297
A040297
A040297
A040114
A040114
A040114

TABLET; VAGINAL

VAGIFEM

XX + NOVO NORDISK INC

10MCG

N020908 002

Nov 25, 2009

INSERT, EXTENDED RELEASE; VAGINAL

FEMRING
GALEN LTD
EQ 0.05MG BASE/24HR
XX
EQ 0.1MG BASE/24HR
XX +

N021367 001
N021367 002

Mar 20, 2003

Mar 20, 2003

TABLET; ORAL
FEMTRACE
WARNER CHILCOTT
XX
XX

N021633 001
N021633 002

Aug 20, 2004

Aug 20, 2004

001
002
003
001
002
003
001
002
003
003
001
002

Oct
Oct
Oct
Apr
Apr
Apr
Apr
Apr
Apr
Mar
Mar
Mar

22,
22,
22,
21,
21,
21,
17,
17,
17,
14,
14,
14,

1997
1997
1997
1999
1999
1999
2002
2002
2002
1996
1996
1996

ESTRADIOL ACETATE

0.45MG
0.9MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 164 (of 424)

ESTRADIOL ACETATE
TABLET; ORAL

FEMTRACE

XX + WARNER CHILCOTT

1.8MG

N021633 003

5MG/ML

A085470 003

5MG/ML

A085620 001

0.25%

N021371 001

10MG/ML
20MG/ML
40MG/ML

N009402 002
N009402 004
N009402 003

20MG/ML
40MG/ML
10MG/ML
20MG/ML
40MG/ML
20MG/ML
40MG/ML

A090920
A090920
A040628
A040628
A040628
A083547
A083714

Aug 20, 2004

ESTRADIOL CYPIONATE
INJECTABLE; INJECTION
DEPO-ESTRADIOL
AO + PHARMACIA AND UPJOHN
ESTRADIOL CYPIONATE
WATSON LABS
AO

ESTRADIOL HEMIHYDRATE
EMULSION; TOPICAL

ESTRASORB

XX + MEDICIS

Oct 09, 2003

ESTRADIOL VALERATE

AO
AO
AO
AO
AO
AO
AO
AO
AO
AO

INJECTABLE; INJECTION
DELESTROGEN
+ JHP PHARMS
+
+
ESTRADIOL VALERATE
LUITPOLD
SANDOZ

WATSON LABS

001
002
001
002
003
001
001

Jan
Jan
Oct
Oct
Oct

19,
19,
04,
04,
04,

2010
2010
2007
2007
2007

ESTRADIOL; LEVONORGESTREL
FILM, EXTENDED RELEASE; TRANSDERMAL

CLIMARA PRO

0.045MG/24HR;0.015MG/24HR
XX + BAYER HLTHCARE

N021258 001

Nov 21, 2003

N020870 001
N020870 002

Aug 07, 1998

Aug 07, 1998

N020907 002
N020907 001

Dec 28, 2006

Nov 18, 1998

A079193 001
A078324 002
A078324 001

May 11, 2010

Jun 09, 2011
Apr 17, 2008

A076812 001

Apr 29, 2005

N021040 001

Oct 22, 1999

ESTRADIOL; NORETHINDRONE ACETATE

FILM, EXTENDED RELEASE; TRANSDERMAL
COMBIPATCH
NOVARTIS
0.05MG/24HR;0.14MG/24HR
XX
0.05MG/24HR;0.25MG/24HR
XX +

AB
AB
AB
AB
AB

TABLET; ORAL
ACTIVELLA
NOVO NORDISK INC
0.5MG;0.1MG
+
1MG;0.5MG
ESTRADIOL AND NORETHINDRONE ACETATE
BARR
1MG;0.5MG
BRECKENRIDGE PHARM
0.5MG;0.1MG
1MG;0.5MG

ESTRADIOL; NORGESTIMATE
TABLET; ORAL
ESTRADIOL AND NORGESTIMATE
BARR
AB
1MG,1MG;N/A,0.09MG
PREFEST
AB + TEVA WOMENS
1MG,1MG;N/A,0.09MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 165 (of 424)

ESTRAMUSTINE PHOSPHATE SODIUM

CAPSULE; ORAL

EMCYT

XX + PHARMACIA AND UPJOHN

EQ 140MG PHOSPHATE

N018045 001

CREAM; TOPICAL, VAGINAL

PREMARIN

XX + WYETH PHARMS INC

0.625MG/GM

N020216 001

INJECTABLE; INJECTION

PREMARIN

XX + WYETH PHARMS INC

25MG/VIAL

N010402 001

TABLET; ORAL
PREMARIN
WYETH PHARMS INC
XX
XX
XX +
XX +
XX +

0.3MG
0.45MG
0.625MG
0.9MG
1.25MG

N004782
N004782
N004782
N004782
N004782

ESTROGENS, CONJUGATED

003
006
004
005
001

Jul 16, 2003

Jan 26, 1984

ESTROGENS, CONJUGATED SYNTHETIC A

CREAM; VAGINAL

SYNTHETIC CONJUGATED ESTROGENS A

XX + TEVA WOMENS
0.625MG/GM

N021788 001

Nov 28, 2008

TABLET; ORAL
CENESTIN
XX
TEVA WOMENS
XX
XX
XX
XX +

N020992
N020992
N020992
N020992
N020992

001
005
002
003
004

Jun
Feb
Mar
Mar
Mar

21,
05,
24,
24,
13,

2002
2004
1999
1999
2000

N021443
N021443
N021443
N021443
N021443

001
002
003
005
004

Dec
Dec
May
Apr
May

20,
20,
10,
27,
10,

2004
2004
2004
2007
2004

0.3MG
0.45MG
0.625MG
0.9MG
1.25MG

ESTROGENS, CONJUGATED SYNTHETIC B

TABLET; ORAL
ENJUVIA
TEVA WOMENS
XX
XX
XX
XX
XX +

0.3MG
0.45MG
0.625MG
0.9MG
1.25MG

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

XX
XX
XX
XX
XX

TABLET; ORAL-28

PREMPHASE 14/14

+ WYETH PHARMS INC

PREMPRO
+ WYETH PHARMS INC
+
+
+

0.625MG,0.625MG;N/A,5MG

N020527 002

Nov 17, 1995

0.3MG;1.5MG
0.45MG;1.5MG
0.625MG;2.5MG
0.625MG;5MG

N020527
N020527
N020527
N020527

005
004
001
003

Jun
Mar
Nov
Jan

0.3MG
0.625MG
1.25MG
2.5MG

A084951
A084948
A084950
A084949

001

001

001

001

ESTROGENS, ESTERIFIED
TABLET; ORAL

MENEST

MONARCH PHARMS
XX
XX
XX
XX +

04,
12,
17,
09,

2003
2003
1995
1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 166 (of 424)

ESTRONE
INJECTABLE; INJECTION

ESTRONE

XX + WATSON LABS

5MG/ML

A085239 001

0.75MG
1.5MG
3MG
0.75MG
1.5MG
0.75MG
1.5MG
3MG
6MG

A040135
A040135
A040135
A040359
A040359
A081213
A081214
A081215
A081216

0.75MG

A083220 001

1.5MG

A083220 002

3MG

A083220 003

6MG

A083220 004

0.75MG
1.5MG

A089567 001
A089582 001

Feb 27, 1991

Jul 17, 1991

1MG
2MG
3MG

N021476 001
N021476 002
N021476 003

Dec 15, 2004

Dec 15, 2004
Dec 15, 2004

EQ 50MG BASE/VIAL

N016093 001

25MG

N016092 001

ESTROPIPATE
TABLET; ORAL
ESTROPIPATE
BARR
AB
AB
AB
MYLAN
AB
AB
WATSON LABS
AB
AB
AB
AB
OGEN .625
PHARMACIA AND UPJOHN
AB
OGEN 1.25
PHARMACIA AND UPJOHN
AB
OGEN 2.5
AB + PHARMACIA AND UPJOHN
OGEN 5
PHARMACIA AND UPJOHN
AB
ORTHO-EST
SUN PHARM INDS (IN)
AB
AB

001
002
003
001
002
001
001
001
001

Nov
Nov
Nov
Aug
Aug
Sep
Sep
Sep
Sep

27,
27,
27,
26,
26,
23,
23,
23,
23,

1996
1996
1996
1999
1999
1993
1993
1993
1993

ESZOPICLONE
TABLET; ORAL
LUNESTA
SUNOVION PHARMS INC
XX
XX
XX +

ETHACRYNATE SODIUM
INJECTABLE; INJECTION

EDECRIN

XX + ATON

ETHACRYNIC ACID
TABLET; ORAL

EDECRIN

XX + ATON

ETHAMBUTOL HYDROCHLORIDE
TABLET; ORAL
ETHAMBUTOL HYDROCHLORIDE
BARR
AB
400MG
LUPIN
AB
100MG
AB
400MG
WEST WARD
AB
100MG
AB +
400MG
MYAMBUTOL
STI PHARMA LLC
AB
100MG
AB
400MG

A076057
A078939
A078939
A075095
A075095

001
001
002
001
002

N016320 001
N016320 003

Nov
Jun
Jun
Nov
Nov

26,
17,
17,
30,
30,

2001
2009
2009
1999
1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 167 (of 424)

ETHANOLAMINE OLEATE
INJECTABLE; INJECTION
ETHAMOLIN
XX + QOL MEDCL

N019357 001

Dec 22, 1988

0.035MG;1MG

A076785 001

May 23, 2005

0.035MG;1MG

A072721 001

Dec 30, 1991

0.05MG;1MG

A072723 001

Dec 30, 1991

N021187 001

Oct 03, 2001

A079064 001

Sep 27, 2010

A091674 001
A077502 001

Oct 26, 2011

Nov 23, 2011

A079218 001
A200407 001

Jun 06, 2011

Oct 25, 2011

A078834 001

May 31, 2011

N022262 001

Oct 24, 2008

N021864 001

May 22, 2007

A077101 001

Sep 06, 2006

N021544 001

Sep 05, 2003

N021840 001

May 25, 2006

0.03MG;0.15MG

A079102 001

Aug 03, 2010

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1
25MG

A075809 002

Jul 16, 2001

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1
25MG

A090719 001

Dec 29, 2010

0.03MG;0.15MG

A073594 001

Dec 13, 1993

0.03MG;0.15MG

N018782 001

Jul 21, 1982

0.03MG;0.15MG

A075866 002

May 23, 2002

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1
25MG

A074538 002

Dec 18, 1997

0.02MG;0.1MG

A075796 001

Apr 30, 2001

50MG/ML

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

TABLET; ORAL-28
KELNOR
BARR
AB
ZOVIA 1/35E-28
WATSON LABS
AB
ZOVIA 1/50E-28
XX + WATSON LABS

ETHINYL ESTRADIOL; ETONOGESTREL

RING; VAGINAL
NUVARING
XX + ORGANON USA INC

0.015MG;0.12MG

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET; ORAL
INTROVALE
SANDOZ
AB
0.03MG;0.15MG
LEVONORGESTREL AND ETHINYL ESTRADIOL
LUPIN LTD
AB
0.02MG,0.01MG;0.1MG,N/A
VINTAGE PHARMS
AB
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1
25MG
WATSON LABS
AB
0.02MG;0.09MG
AB
0.02MG,0.01MG;0.1MG,N/A
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
WATSON LABS
AB
0.03MG,0.01MG;0.15MG,N/A
LOSEASONIQUE
TEVA WOMENS
AB
0.02MG,0.01MG;0.1MG,N/A
LYBREL
AB + WYETH PHARMS INC
0.02MG;0.09MG
QUASENSE
WATSON LABS
AB
0.03MG;0.15MG
SEASONALE
AB + DURAMED RES
0.03MG;0.15MG
SEASONIQUE
AB + TEVA WOMENS
0.03MG,0.01MG;0.15MG,N/A
TABLET; ORAL-28
ALTAVERA
SANDOZ
AB
ENPRESSE-28
DURAMED PHARMS BARR
AB

AB

AB
AB
AB
AB

AB1

LEVONEST
NOVAST LABS LTD
LEVORA 0.15/30-28
WATSON LABS
NORDETTE-28
+ DURAMED
PORTIA-28
BARR
TRIVORA-28
+ WATSON LABS
AVIANE-28
DURAMED PHARMS BARR

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 168 (of 424)

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET; ORAL-28
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB1 + WATSON LABS
0.02MG;0.1MG
ORSYTHIA
VINTAGE PHARMS
AB1
0.02MG;0.1MG
LESSINA-28
BARR
AB2
0.02MG;0.1MG
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB2 + WATSON LABS
0.02MG;0.1MG

A076625 001

Nov 18, 2004

A077099 001

May 11, 2011

A075803 002

Mar 20, 2002

A077681 001

May 31, 2006

N021180 001

Nov 20, 2001

A071480 001

Apr 12, 1988

A070685 001

Jan 29, 1987

ETHINYL ESTRADIOL; NORELGESTROMIN

FILM, EXTENDED RELEASE; TRANSDERMAL

ORTHO EVRA

0.02MG/24HR;0.15MG/24HR
XX + JANSSEN PHARMS

ETHINYL ESTRADIOL; NORETHINDRONE

AB
AB
AB
AB
XX
XX
XX
XX

AB
AB
AB
AB
AB
AB

AB
AB

AB
AB
AB
AB

TABLET; ORAL-21
NORETHIN 1/35E-21
WATSON LABS
0.035MG;1MG
NORETHINDRONE AND ETHINYL ESTRADIOL
WATSON LABS
0.035MG;1MG
NORINYL 1+35 21-DAY
WATSON LABS
0.035MG;1MG
NORTREL 1/35-21
BARR
0.035MG;1MG
NORETHINDRONE AND ETHINYL ESTRADIOL
WATSON LABS
0.035MG;0.4MG
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
WATSON LABS
0.035MG,0.035MG;0.5MG,1MG
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
0.035MG,0.035MG;0.5MG,1MG
WATSON LABS
NORTREL 7/7/7
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
BARR
G
TABLET; ORAL-28
ARANELLE
BARR
BALZIVA-28
BARR
BREVICON 28-DAY
WATSON LABS
BRIELLYN
GLENMARK GENERICS
CYCLAFEM 1/35
VINTAGE
CYCLAFEM 7/7/7
VINTAGE
DASETTA 1/35
NOVAST LABS LTD
DASETTA 7/7/7
NOVAST LABS LTD

N017565 001
A072693 001

Feb 28, 1992

A078379 001

Feb 23, 2010

A071043 001

Apr 01, 1988

A071041 001

Sep 24, 1991

A075478 001

Aug 30, 2002

0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG

A076783 001

Sep 29, 2004

0.035MG;0.4MG

A076238 001

Apr 22, 2004

0.035MG;0.5MG

N017743 001

0.035MG;0.4MG

A090538 001

Mar 22, 2011

0.035MG;1MG

A076337 001

Nov 12, 2010

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
G

A076338 001

Nov 16, 2010

0.035MG;1MG

A090948 001

Dec 22, 2011

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
G

A090946 001

Dec 22, 2011

MODICON 28
+ JANSSEN PHARMS
0.035MG;0.5MG
NORETHIN 1/35E-28
WATSON LABS
0.035MG;1MG
NORETHINDRONE AND ETHINYL ESTRADIOL
WATSON LABS
0.035MG;0.4MG

0.035MG;0.5MG

N017735 001
A071481 001

Apr 12, 1988

A078323 001
A070686 001

Feb 04, 2010

Jan 29, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 169 (of 424)

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET; ORAL-28
NORETHINDRONE AND ETHINYL ESTRADIOL
WATSON LABS
AB
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
G
AB
0.035MG;1MG
NORINYL 1+35 28-DAY
WATSON LABS
0.035MG;1MG
AB
NORTREL 0.5/35-28
BARR
0.035MG;0.5MG
AB
NORTREL 1/35-28
BARR
0.035MG;1MG
AB
NORTREL 7/7/7
BARR
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
AB
G
ORTHO-NOVUM 1/35-28
AB + JANSSEN PHARMS
0.035MG;1MG
ORTHO-NOVUM 7/7/7-28
AB + JANSSEN PHARMS
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
G
OVCON-35
AB + WARNER CHILCOTT
0.035MG;0.4MG
PHILITH
NOVAST LABS LTD
AB
0.035MG;0.4MG
TRI-NORINYL 28-DAY
AB + WATSON LABS
0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
WATSON LABS
0.035MG,0.035MG;0.5MG,1MG
XX
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
WATSON LABS
0.035MG,0.035MG;0.5MG,1MG
XX
OVCON-50
0.05MG;1MG
XX + WARNER CHILCOTT

AB
AB
AB
XX

TABLET, CHEWABLE; ORAL

FEMCON FE
+ WARNER CHILCOTT
0.035MG;0.4MG
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
BARR
0.035MG;0.4MG
WATSON LABS
0.035MG;0.4MG
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
+ WATSON LABS INC
0.025MG;0.8MG

A076393 001

Feb 04, 2010

A070687 001

Jan 29, 1987

N017565 002
A072695 001

Feb 28, 1992

A072696 001

Feb 28, 1992

A075478 002

Aug 30, 2002

N017919 002
N018985 002

Apr 04, 1984

N017716 001
A090947 001

Dec 22, 2011

N018977 002

Apr 13, 1984

A071044 001

Apr 01, 1988

A071042 001

Sep 24, 1991

N017576 001

N021490 001

Nov 14, 2003

A078965 001
A078892 001

Aug 05, 2010

Sep 26, 2011

N022573 001

Dec 22, 2010

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

AB
AB
AB
AB
XX
XX

TABLET; ORAL
FEMHRT
+ WARNER CHILCOTT
0.005MG;1MG
N021065 002
LOESTRIN 24 FE
+ WARNER CHILCOTT
0.02MG;1MG
N021871 001
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
BARR
0.005MG;1MG
A076221 001
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
WATSON LABS
0.02MG;1MG
A078267 001
FEMHRT
WARNER CHILCOTT
0.0025MG;0.5MG
N021065 001
LO LOESTRIN FE
+ WARNER CHILCOTT CO
0.01MG,0.01MG;1MG,N/A
N022501 001

TABLET; ORAL-21
JUNEL 1.5/30
BARR
AB
JUNEL 1/20
BARR
AB

Oct 15, 1999

Feb 17, 2006
Nov 06, 2009
Sep 01, 2009
Jan 14, 2005
Oct 21, 2010

0.03MG;1.5MG

A076381 001

May 30, 2003

0.02MG;1MG

A076380 001

May 30, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 170 (of 424)

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

AB
AB
AB
AB
XX

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL-21
LOESTRIN 21 1.5/30
WARNER CHILCOTT
LOESTRIN 21 1/20
WARNER CHILCOTT
MICROGESTIN 1.5/30
WATSON LABS
MICROGESTIN 1/20
WATSON LABS
TRI-LEGEST 21
BARR

0.03MG;1.5MG

N017875 001

0.02MG;1MG

N017876 001

0.03MG;1.5MG

A075548 002

Jul 30, 2003

0.02MG;1MG

A075647 002

Jul 30, 2003

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

A076405 001

Oct 26, 2007

N020130 002

Oct 09, 1996

A077075 001

Apr 28, 2005

A077077 001

May 20, 2005

A076064 001

Sep 18, 2003

A076081 001

Sep 18, 2003

TABLET; ORAL-28
ESTROSTEP FE
+ WARNER CHILCOTT
0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
GILDESS FE 1.5/30
VINTAGE
0.03MG;1.5MG
GILDESS FE 1/20
VINTAGE
0.02MG;1MG
JUNEL FE 1.5/30
BARR
0.03MG;1.5MG
JUNEL FE 1/20
BARR
0.02MG;1MG
LOESTRIN FE 1.5/30
+ WARNER CHILCOTT
0.03MG;1.5MG
LOESTRIN FE 1/20
WARNER CHILCOTT
0.02MG;1MG
MICROGESTIN FE 1.5/30
WATSON LABS
0.03MG;1.5MG
MICROGESTIN FE 1/20
WATSON LABS
0.02MG;1MG
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
WATSON LABS
0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
TRI-LEGEST FE
BARR
0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

N017355 001
N017354 001
A075548 001

Feb 05, 2001

A075647 001

Feb 05, 2001

A076629 001

Mar 18, 2010

A076105 001

Oct 26, 2007

A200494 001

Jun 17, 2011

A090479 001

Mar 09, 2011

A076626 001

Aug 17, 2006

A076627 001

Aug 17, 2006

N019653 002

Dec 29, 1989

N019697 001

Jul 03, 1992

N021241 001

Aug 22, 2002

A076334 001

Jan 09, 2004

A075804 001

Sep 25, 2002

ETHINYL ESTRADIOL; NORGESTIMATE

TABLET; ORAL
NORGESTIMATE AND ETHINYL ESTRADIOL
GLENMARK GENERICS
AB
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,
0.25MG
TABLET; ORAL-28
NORGESTIMATE AND ETHINYL ESTRADIOL
WATSON LABS
AB
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,
0.25MG
AB
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,
0.25MG
AB
0.035MG;0.25MG
ORTHO CYCLEN-28
AB + JANSSEN PHARMS
0.035MG;0.25MG
ORTHO TRI-CYCLEN
AB + JANSSEN PHARMS
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,
0.25MG
ORTHO TRI-CYCLEN LO
AB + JANSSEN PHARMS
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,
0.25MG
PREVIFEM
VINTAGE
AB
0.035MG;0.25MG
SPRINTEC
BARR
AB
0.035MG;0.25MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 171 (of 424)

ETHINYL ESTRADIOL; NORGESTIMATE

TABLET; ORAL-28
TRI LO SPRINTEC
BARR
AB

AB

TRI-PREVIFEM
VINTAGE

AB

TRI-SPRINTEC
BARR

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,
0.25MG

A076784 001

Jun 29, 2009

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,
0.25MG

A076335 001

Mar 26, 2004

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,
0.25MG

A075808 001

Dec 29, 2003

0.03MG;0.3MG

A075840 001

Nov 30, 2001

0.03MG;0.3MG

A075288 001

Jul 28, 1999

0.03MG;0.3MG

A075840 002

Nov 30, 2001

0.03MG;0.3MG

N017802 001

0.03MG;0.3MG

A075288 002

Jul 28, 1999

0.05MG;0.5MG

A075406 002

Dec 15, 1999

250MG

N013026 002

250MG
250MG

A040430 001
A040686 001

250MG

N012380 001

250MG/5ML
250MG/5ML
250MG/5ML

A040506 001
A040253 001
A081306 001

250MG/5ML

A080258 001

250MG

N010841 001

200MG
400MG

N017831 001
N017831 002

200MG

A075800 001

ETHINYL ESTRADIOL; NORGESTREL

TABLET; ORAL-21
CRYSELLE
DURAMED PHARMS BARR
AB
LOW-OGESTREL-21
AB + WATSON LABS

AB
AB
AB
XX

TABLET; ORAL-28
CRYSELLE
DURAMED PHARMS BARR
LO/OVRAL-28
WYETH PHARMS
LOW-OGESTREL-28
WATSON LABS
OGESTREL 0.5/50-28
+ WATSON LABS

ETHIONAMIDE
TABLET; ORAL

TRECATOR

XX + WYETH PHARMS INC

ETHOSUXIMIDE
CAPSULE; ORAL
ETHOSUXIMIDE
BANNER PHARMACAPS
AB
VERSAPHARM
AB
ZARONTIN
AB + PARKE DAVIS

AA
AA
AA
AA

SYRUP; ORAL
ETHOSUXIMIDE
MIKART
PHARM ASSOC
TEVA PHARMS
ZARONTIN
+ PARKE DAVIS

Oct 28, 2002

May 28, 2008

Dec 22, 2003

Nov 22, 2000
Jul 30, 1993

ETHOTOIN
TABLET; ORAL

PEGANONE

XX + LUNDBECK INC

ETIDRONATE DISODIUM
TABLET; ORAL
DIDRONEL
PROCTER AND GAMBLE
AB
AB +
ETIDRONATE DISODIUM
MYLAN
AB

Jan 24, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 172 (of 424)

ETIDRONATE DISODIUM
TABLET; ORAL
ETIDRONATE DISODIUM
MYLAN
AB

400MG

A075800 002

Jan 24, 2003

CAPSULE; ORAL
ETODOLAC
APOTEX
AB
AB
TARO
AB
AB +
TEVA
AB

200MG
300MG
200MG
300MG
300MG

A075419
A075419
A075078
A075078
A075126

001
002
001
002
002

Jul
Jul
Apr
Apr
Sep

28,
28,
30,
30,
16,

2000
2000
1998
1998
1999

TABLET; ORAL
ETODOLAC
APOTEX INC
AB
AB
MYLAN
AB
AB
SANDOZ
AB
AB
TARO PHARM INDS
AB
AB +
TEVA
AB
AB

400MG
500MG
400MG
500MG
400MG
500MG
400MG
500MG
400MG
500MG

A076004
A076004
A075104
A075104
A074903
A074903
A075074
A075074
A075009
A075009

001
002
001
002
001
002
001
002
001
002

Dec
Dec
Feb
Nov
Apr
Apr
Mar
Apr
Nov
Dec

03,
03,
06,
20,
11,
19,
11,
25,
26,
28,

2002
2002
1998
1998
1997
1999
1998
2000
1997
1999

TABLET, EXTENDED RELEASE; ORAL

ETODOLAC
TARO
AB
400MG
AB
500MG
AB
600MG
TEVA
AB
400MG
AB
500MG
AB +
600MG

A076174
A076174
A076174
A075665
A075665
A075665

001
002
003
003
002
001

Mar
Mar
Mar
Feb
Jul
Jul

13,
13,
13,
05,
31,
31,

2003
2003
2003
2001
2000
2000

ETODOLAC

ETOMIDATE
INJECTABLE; INJECTION
AMIDATE
+ HOSPIRA
ETOMIDATE
BEDFORD
LUITPOLD
STRIDES ARCOLAB LTD

2MG/ML

N018227 001

Sep 07, 1982

2MG/ML
2MG/ML
2MG/ML

A074593 001
A078867 001
A078289 001

Nov 04, 1996

Dec 22, 2009
Jan 02, 2009

68MG/IMPLANT

N021529 001

Jul 17, 2006

68MG/IMPLANT

N021529 002

May 31, 2011

CAPSULE; ORAL

ETOPOSIDE

XX + MYLAN

50MG

A075635 001

Sep 19, 2001

INJECTABLE; INJECTION
ETOPOSIDE
ACCORD HLTHCARE INC
AP
APP PHARMS
AP
AP + BEDFORD

20MG/ML
20MG/ML
20MG/ML

A074513 001
A074983 001
A074290 001

Mar 14, 1996

Sep 30, 1998
Jul 17, 1995

AP
AP
AP
AP

ETONOGESTREL
IMPLANT; IMPLANTATION

IMPLANON

XX + ORGANON USA INC

NEXPLANON
XX + ORGANON USA INC

ETOPOSIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 173 (of 424)

ETOPOSIDE
INJECTABLE; INJECTION
ETOPOSIDE
PHARMACHEMIE
AP
TEVA PARENTERAL
AP
AP

A074227 001
A074284 001
A074529 001

Feb 22, 1996

Feb 10, 1994
Jul 24, 1996

N020457 001

May 17, 1996

100MG
200MG

N022187 001
N022187 002

Jan 18, 2008

Dec 22, 2010

2.5MG
5MG
10MG

N022334 003
N022334 001
N022334 002

Jul 09, 2010

Mar 30, 2009
Mar 30, 2009

0.25MG
0.5MG
0.75MG

N021560 001
N021560 002
N021560 003

Apr 20, 2010

Apr 20, 2010
Apr 20, 2010

25MG

N020753 001

Oct 21, 1999

25MG

A077431 001

Apr 01, 2011

300MCG/1.2ML (250MCG/ML)
600MCG/2.4ML (250MCG/ML)

N021773 001
N021773 002

Apr 28, 2005

Apr 28, 2005

10MG

N021445 001

Oct 25, 2002

10MG;10MG
10MG;20MG
10MG;40MG
10MG;80MG

N021687
N021687
N021687
N021687

Jul
Jul
Jul
Jul

50MG

N022345 001

20MG/ML
20MG/ML
20MG/ML

ETOPOSIDE PHOSPHATE
INJECTABLE; INJECTION

ETOPOPHOS PRESERVATIVE FREE

XX + BRISTOL MYERS SQUIBB EQ 100MG BASE/VIAL

ETRAVIRINE
TABLET; ORAL

INTELENCE

TIBOTEC

XX
XX +

EVEROLIMUS
TABLET; ORAL

AFINITOR

NOVARTIS

XX
XX
XX +

ZORTRESS

NOVARTIS

XX
XX
XX +

EXEMESTANE
TABLET; ORAL
AROMASIN
AB + PHARMACIA AND UPJOHN
EXEMESTANE
ROXANE
AB

EXENATIDE SYNTHETIC
INJECTABLE; SUBCUTANEOUS

BYETTA

XX + AMYLIN

XX +

EZETIMIBE
TABLET; ORAL

ZETIA

XX + MSP SINGAPORE

EZETIMIBE; SIMVASTATIN
TABLET; ORAL

VYTORIN

MSD INTL

XX
XX
XX
XX +

001
002
003
004

23,
23,
23,
23,

2004
2004
2004
2004

EZOGABINE
TABLET; ORAL

POTIGA

VALEANT PHARMS

XX

Jun 10, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 174 (of 424)

EZOGABINE
TABLET; ORAL
POTIGA
VALEANT PHARMS
XX
XX
XX +

200MG
300MG
400MG

N022345 002
N022345 003
N022345 004

Jun 10, 2011

Jun 10, 2011
Jun 10, 2011

125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG

A091480
A091480
A091480
A091114
A091114
A091114
A201333
A201333
A201333
A090128
A090128
A090128
A077487
A077487
A077487
A078278
A078278
A078278

Jul
Jul
Jul
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Aug
Aug
Aug
Mar
Mar
Mar

125MG
250MG
500MG

N020363 003
N020363 001
N020363 002

Dec 11, 1995

Apr 26, 1996
Jun 29, 1994

40MG/5ML
40MG/5ML

A090440 001
A091020 001

Jun 29, 2010

May 27, 2010

40MG/5ML

N019527 001

Feb 02, 1987

A075709
A075488
A075799
A075651
A075684
A078641

001
001
001
001
001
001

Apr
Apr
Apr
Apr
Apr
Jun

16,
16,
30,
16,
16,
25,

2001
2001
2002
2001
2001
2008

A075813
A075486
A075789
A075622
A075825
A076324
A078642

001
001
001
001
001
001
001

Apr
Apr
Apr
Apr
Apr
Nov
Jun

16,
16,
30,
16,
17,
27,
25,

2001
2001
2002
2001
2001
2002
2008

FAMCICLOVIR
TABLET; ORAL
FAMCICLOVIR
APOTEX
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
MYLAN
AB
AB
AB
ROXANE
AB
AB
AB
TEVA PHARMS
AB
AB
AB
WATSON LABS
AB
AB
AB
FAMVIR
NOVARTIS
AB
AB
AB +

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

22,
22,
22,
21,
21,
21,
24,
24,
24,
21,
21,
21,
24,
24,
24,
21,
21,
21,

2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2007
2007
2007
2011
2011
2011

FAMOTIDINE
FOR SUSPENSION; ORAL
FAMOTIDINE
LUPIN LTD
AB
NAVINTA LLC
AB
PEPCID
AB + SALIX PHARMS

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
FAMOTIDINE
APP PHARMS
+ BAXTER HLTHCARE
+
BEDFORD

10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
PFIZER
10MG/ML
FAMOTIDINE PRESERVATIVE FREE
APP PHARMS
10MG/ML
+ BAXTER HLTHCARE
10MG/ML
+
10MG/ML
BEDFORD
10MG/ML
BEN VENUE
10MG/ML
CLARIS LIFESCIENCES
10MG/ML
PFIZER
10MG/ML
FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)
CLARIS LIFESCIENCES
10MG/ML
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
0.4MG/ML

A076322 001

Nov 27, 2002

A075591 001

May 10, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 175 (of 424)

FAMOTIDINE
TABLET; ORAL
FAMOTIDINE
ALEMBIC PHARMS LTD
AB
AB
APOTEX
AB
AB
CARLSBAD
AB
AB
DR REDDYS LABS LTD
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
MYLAN
AB
AB
AB
AB
PERRIGO
AB
AB
SANDOZ
AB
AB
TEVA
AB
AB
WATSON LABS
AB
AB
WOCKHARDT
AB
AB
PEPCID
MERCK
AB
AB +

001
002
001
002
001
002
001
002
001
002
001
001
002
002
002
001
001
002
001
002
002
001
001
002

May
May
Jul
Jul
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Jul
Jul
May
May
Apr
Apr
Apr
Apr
Apr
Apr

22,
22,
23,
23,
16,
16,
16,
16,
16,
16,
18,
16,
18,
16,
27,
27,
10,
10,
16,
16,
16,
16,
16,
16,

2009
2009
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001
2005
2005
2001
2001
2001
2001
2001
2001
2001
2001

20MG
40MG
20MG
40MG
20MG
40MG
20MG
40MG
20MG
40MG
20MG
20MG
40MG
40MG
20MG
40MG
20MG
40MG
20MG
40MG
20MG
40MG
20MG
40MG

A078916
A078916
A075611
A075611
A075805
A075805
A075718
A075718
A075511
A075511
A075457
A075704
A075457
A075704
A077352
A077352
A075607
A075607
A075311
A075311
A075062
A075062
A075786
A075786

20MG
40MG

N019462 001
N019462 002

Oct 15, 1986

Oct 15, 1986

26.6MG;800MG

N022519 001

Apr 23, 2011

40MG
80MG

N021856 001
N021856 002

Feb 13, 2009

Feb 13, 2009

600MG/5ML

A202385 001

Dec 16, 2011

600MG/5ML

N020189 003

Jul 29, 1993

400MG
600MG

A201680 001
A201680 002

Sep 13, 2011

Sep 13, 2011

400MG
600MG

N020189 001
N020189 002

Jul 29, 1993

Jul 29, 1993

FAMOTIDINE; IBUPROFEN
TABLET; ORAL

DUEXIS

XX + HORIZON PHARMA

FEBUXOSTAT
TABLET; ORAL
ULORIC
TAKEDA PHARMS
XX
XX +

FELBAMATE
SUSPENSION; ORAL
FELBAMATE
AMNEAL PHARMS
AB
FELBATOL
AB + MEDA PHARMS
TABLET; ORAL
FELBAMATE
AMNEAL PHARMS
AB
AB
FELBATOL
MEDA PHARMS
AB
AB +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 176 (of 424)

FELODIPINE
TABLET, EXTENDED RELEASE; ORAL
FELODIPINE
ENDO PHARMS
AB
2.5MG
AB
5MG
AB
10MG
GLENMARK GENERICS
AB
2.5MG
AB
5MG
AB
10MG
MUTUAL PHARM
AB
2.5MG
AB
5MG
AB
10MG
MYLAN
AB
2.5MG
AB
5MG
AB +
10MG
TORRENT PHARMS LTD
AB
2.5MG
AB
5MG
AB
10MG
PLENDIL
ASTRAZENECA
AB
2.5MG
AB
5MG
AB
10MG

A200815
A200815
A200815
A090365
A090365
A090365
A075896
A075896
A075896
A078855
A078855
A078855
A202170
A202170
A202170

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Oct
Oct
Oct
Dec
Dec
Dec
Nov
Nov
Nov
Apr
Apr
Apr
Nov
Nov
Nov

28,
28,
28,
17,
17,
17,
02,
02,
02,
17,
17,
17,
28,
28,
28,

2011
2011
2011
2010
2010
2010
2004
2004
2004
2008
2008
2008
2011
2011
2011

N019834 004
N019834 001
N019834 002

Sep 22, 1994

Jul 25, 1991
Jul 25, 1991

A075868
A075868
A075868
A075753
A075753
A075753

Oct
Oct
Oct
Sep
Apr
Apr

FENOFIBRATE

AB
AB
AB
AB
AB
AB
XX
XX
XX
XX

CAPSULE; ORAL
FENOFIBRATE (MICRONIZED)
IMPAX LABS
67MG
134MG
200MG
TEVA
67MG
134MG
+
200MG
ANTARA (MICRONIZED)
LUPIN ATLANTIS
43MG
+
130MG
LIPOFEN
CIPHER PHARMS INC
50MG
+
150MG

TABLET; ORAL
FENOFIBRATE
IMPAX LABS
AB
AB
LUPIN LTD
AB
AB
MYLAN
AB
AB
RANBAXY
AB
AB
TEVA
AB
AB +
TRICOR
ABBOTT LABS PHARM
AB
AB +
TRIGLIDE
BX + SKYEPHARMA AG
FENOFIBRATE
RANBAXY
XX
FENOGLIDE
SANTARUS
XX
XX +

001
002
003
001
002
003

27,
27,
27,
03,
09,
09,

2003
2003
2003
2002
2002
2002

N021695 001
N021695 003

Nov 30, 2004

Nov 30, 2004

N021612 001
N021612 003

Jan 11, 2006

Jan 11, 2006

54MG
160MG
48MG
145MG
54MG
160MG
54MG
160MG
54MG
160MG

A076509
A076509
A090856
A090856
A076520
A076520
A076635
A076635
A076433
A076433

Mar
Mar
Dec
Dec
Oct
Oct
Oct
Oct
May
May

48MG
145MG

N021656 001
N021656 002

Nov 05, 2004

Nov 05, 2004

160MG

N021350 002

May 07, 2005

107MG

A076635 002

Oct 31, 2005

40MG
120MG

N022118 001
N022118 002

Aug 10, 2007

Aug 10, 2007

001
002
001
002
001
003
001
003
001
002

26,
26,
23,
23,
25,
25,
31,
31,
13,
13,

2008
2008
2011
2011
2007
2007
2005
2005
2005
2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 177 (of 424)

FENOFIBRATE
TABLET; ORAL
TRIGLIDE
SKYEPHARMA AG
XX

50MG

N021350 001

May 07, 2005

35MG
105MG

N022418 001
N022418 002

Aug 14, 2009

Aug 14, 2009

EQ 10MG BASE/ML

N019922 001

Sep 23, 1997

EQ 10MG BASE/ML
EQ 10MG BASE/ML

A076582 001
A077155 001

Oct 12, 2004

Feb 15, 2005

CAPSULE; ORAL

NALFON

XX + PEDINOL
XX

EQ 200MG BASE
EQ 400MG BASE

N017604 003
N017604 004

Jul 21, 2009

TABLET; ORAL
FENOPROFEN CALCIUM
IVAX SUB TEVA PHARMS
AB
AB + MYLAN

EQ 600MG BASE
EQ 600MG BASE

A072557 001
A072267 001

Aug 29, 1988

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

A077062
A077051
A077154
A076258
A077775
A077449
A076709

Aug
Aug
Feb
Jan
Oct
Oct
Aug

FENOFIBRIC ACID
TABLET; ORAL
FIBRICOR
AR HOLDING CO INC
XX
XX +

FENOLDOPAM MESYLATE
INJECTABLE; INJECTION
CORLOPAM
AP + HOSPIRA
FENOLDOPAM MESYLATE
BEDFORD LABS
AP
SANDOZ
AP

FENOPROFEN CALCIUM

FENTANYL

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

FILM, EXTENDED RELEASE; TRANSDERMAL

DURAGESIC-100
JANSSEN PHARMS
100MCG/HR
DURAGESIC-12
JANSSEN PHARMS
12.5MCG/HR
DURAGESIC-25
+ JANSSEN PHARMS
25MCG/HR
DURAGESIC-50
JANSSEN PHARMS
50MCG/HR
DURAGESIC-75
JANSSEN PHARMS
75MCG/HR
FENTANYL-100
ACTAVIS
100MCG/HR
LAVIPHARM LABS
100MCG/HR
MALLINCKRODT INC
100MCG/HR
MYLAN TECHNOLOGIES
100MCG/HR
NOVEN
100MCG/HR
TEVA PHARMS
100MCG/HR
WATSON LABS
100MCG/HR
FENTANYL-12
MYLAN TECHNOLOGIES
12.5MCG/HR
FENTANYL-25
ACTAVIS
25MCG/HR
LAVIPHARM LABS
25MCG/HR
MALLINCKRODT INC
25MCG/HR
MYLAN TECHNOLOGIES
25MCG/HR
NOVEN
25MCG/HR
TEVA PHARMS
25MCG/HR
WATSON LABS
25MCG/HR

004
004
004
004
004
004
004

20,
04,
09,
28,
16,
20,
20,

2007
2006
2011
2005
2009
2008
2007

A076258 005

Jan 23, 2007

A077062
A077051
A077154
A076258
A077775
A077449
A076709

Aug
Aug
Feb
Jan
Oct
Oct
Aug

001
001
001
001
001
001
001

20,
04,
09,
28,
16,
20,
20,

2007
2006
2011
2005
2009
2008
2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 178 (of 424)

FENTANYL

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

FILM, EXTENDED RELEASE; TRANSDERMAL

FENTANYL-50
ACTAVIS
50MCG/HR
LAVIPHARM LABS
50MCG/HR
MALLINCKRODT INC
50MCG/HR
MYLAN TECHNOLOGIES
50MCG/HR
NOVEN
50MCG/HR
TEVA PHARMS
50MCG/HR
WATSON LABS
50MCG/HR
FENTANYL-75
ACTAVIS
75MCG/HR
LAVIPHARM LABS
75MCG/HR
MALLINCKRODT INC
75MCG/HR
MYLAN TECHNOLOGIES
75MCG/HR
NOVEN
75MCG/HR
TEVA PHARMS
75MCG/HR
WATSON LABS
75MCG/HR

A077062
A077051
A077154
A076258
A077775
A077449
A076709

002
002
002
002
002
002
002

Aug
Aug
Feb
Jan
Oct
Oct
Aug

20,
04,
09,
28,
16,
20,
20,

2007
2006
2011
2005
2009
2008
2007

A077062
A077051
A077154
A076258
A077775
A077449
A076709

003
003
003
003
003
003
003

Aug
Aug
Feb
Jan
Oct
Oct
Aug

20,
04,
09,
28,
16,
20,
20,

2007
2006
2011
2005
2009
2008
2007

N022266
N022266
N022266
N022266
N022266

001
002
003
004
005

Jul
Jul
Jul
Jul
Jul

16,
16,
16,
16,
16,

2009
2009
2009
2009
2009

FENTANYL CITRATE
FILM; BUCCAL
ONSOLIS
MEDA PHARMS
XX
XX +
XX
XX
XX

AP
AP
AP
AP

EQ
EQ
EQ
EQ
EQ

0.2MG
0.4MG
0.6MG
0.8MG
1.2MG

BASE
BASE
BASE
BASE
BASE

INJECTABLE; INJECTION
FENTANYL CITRATE
HOSPIRA
EQ 0.05MG BASE/ML
FENTANYL CITRATE PRESERVATIVE FREE
+ BAXTER HLTHCARE
EQ 0.05MG BASE/ML
HOSPIRA
EQ 0.05MG BASE/ML
SUBLIMAZE PRESERVATIVE FREE
+ AKORN
EQ 0.05MG BASE/ML

SPRAY, METERED; NASAL

LAZANDA
ARCHIMEDES
XX
XX +

100MCG
400MCG

N019115 001

Jan 12, 1985

N019101 001
A072786 001

Jul 11, 1984

Sep 24, 1991

N016619 001

N022569 001
N022569 002

Jun 30, 2011

Jun 30, 2011

TABLET; BUCCAL
FENTANYL CITRATE
WATSON LABS
AB
AB
AB
AB
AB
FENTORA
CEPHALON
AB
AB
AB +
AB
AB

EQ
EQ
EQ
EQ
EQ

0.1MG
0.2MG
0.4MG
0.6MG
0.8MG

BASE
BASE
BASE
BASE
BASE

A079075
A079075
A079075
A079075
A079075

001
002
003
004
005

Jan
Jan
Jan
Jan
Jan

07,
07,
07,
07,
07,

2011
2011
2011
2011
2011

EQ
EQ
EQ
EQ
EQ

0.1MG
0.2MG
0.4MG
0.6MG
0.8MG

BASE
BASE
BASE
BASE
BASE

N021947
N021947
N021947
N021947
N021947

001
002
003
004
005

Sep
Sep
Sep
Sep
Sep

25,
25,
25,
25,
25,

2006
2006
2006
2006
2006

TABLET; SUBLINGUAL
ABSTRAL
PROSTRAKAN INC
XX
XX
XX
XX +
XX

EQ
EQ
EQ
EQ
EQ

0.1MG
0.2MG
0.3MG
0.4MG
0.6MG

BASE
BASE
BASE
BASE
BASE

N022510
N022510
N022510
N022510
N022510

001
002
003
004
005

Jan
Jan
Jan
Jan
Jan

07,
07,
07,
07,
07,

2011
2011
2011
2011
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 179 (of 424)

FENTANYL CITRATE
TABLET; SUBLINGUAL
ABSTRAL
PROSTRAKAN INC
XX

EQ 0.8MG BASE

TROCHE/LOZENGE; TRANSMUCOSAL
ACTIQ
CEPHALON
AB
EQ 0.2MG BASE
AB +
EQ 0.4MG BASE
AB
EQ 0.6MG BASE
AB
EQ 0.8MG BASE
AB
EQ 1.2MG BASE
AB
EQ 1.6MG BASE
FENTANYL CITRATE
BARR
AB
EQ 0.2MG BASE
AB
EQ 0.4MG BASE
AB
EQ 0.6MG BASE
AB
EQ 0.8MG BASE
AB
EQ 1.2MG BASE
AB
EQ 1.6MG BASE
MALLINCKRODT
AB
EQ 0.2MG BASE
AB
EQ 0.4MG BASE
AB
EQ 0.6MG BASE
AB
EQ 0.8MG BASE
AB
EQ 1.2MG BASE
AB
EQ 1.6MG BASE

N022510 006

Jan 07, 2011

N020747
N020747
N020747
N020747
N020747
N020747

001
002
003
004
005
006

Nov
Nov
Nov
Nov
Nov
Nov

04,
04,
04,
04,
04,
04,

1998
1998
1998
1998
1998
1998

A077312
A077312
A077312
A077312
A077312
A077312
A078907
A078907
A078907
A078907
A078907
A078907

001
002
003
004
005
006
001
002
003
004
005
006

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,

2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009

FERRIC HEXACYANOFERRATE(II)
CAPSULE; ORAL

RADIOGARDASE (PRUSSIAN BLUE)

500MG
XX + HEYL CHEMISCH

N021626 001

Oct 02, 2003

EQ 11.2MG IRON/ML

N020416 001

Aug 30, 1996

EQ 0.175MG IRON/ML

N020410 001

Dec 06, 1996

EQ 510MG IRON/17ML (EQ 30MG IRON/ML)

N022180 001

Jun 30, 2009

N022030 001
N022030 002

Oct 31, 2008

Oct 31, 2008

N021963 001

Oct 16, 2006

A076191 001

Aug 31, 2005

FERUMOXIDES
INJECTABLE; INJECTION

FERIDEX I.V.

XX + AMAG PHARMS INC

FERUMOXSIL
SUSPENSION; ORAL

GASTROMARK

XX + AMAG PHARMS INC

FERUMOXYTOL
SOLUTION; INTRAVENOUS

FERAHEME

XX + AMAG PHARMS INC

FESOTERODINE FUMARATE
TABLET, EXTENDED RELEASE; ORAL
TOVIAZ
PFIZER
4MG
XX
8MG
XX +

FEXOFENADINE HYDROCHLORIDE
SUSPENSION; ORAL

ALLEGRA

XX + SANOFI AVENTIS US

30MG/5ML

TABLET; ORAL
FEXOFENADINE HYDROCHLORIDE
BARR
AB
30MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 180 (of 424)

FEXOFENADINE HYDROCHLORIDE
TABLET; ORAL
FEXOFENADINE HYDROCHLORIDE
BARR
60MG
AB
180MG
AB
DR REDDYS LABS LTD
30MG
AB
60MG
AB
180MG
AB
MYLAN
30MG
AB
60MG
AB
180MG
AB
TEVA
30MG
AB
60MG
AB
180MG
AB

A076191
A076191
A076502
A076502
A076502
A077081
A077081
A077081
A076447
A076447
A076447

002
003
001
002
003
002
003
001
001
002
003

Aug
Aug
Apr
Apr
Apr
Apr
Apr
Apr
Sep
Sep
Sep

31,
31,
11,
11,
11,
11,
11,
16,
01,
01,
01,

2005
2005
2006
2006
2006
2008
2008
2007
2005
2005
2005

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
BARR
AB
60MG;120MG
IMPAX PHARMS
AB
60MG;120MG

A076236 001
A076298 001

Apr 14, 2005

Nov 12, 2010

200MG

N201699 001

May 27, 2011

5MG
5MG
5MG
1MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG

A090121
A077914
A078341
A076436
A076437
A077251
A090061
A077578
A090507
A076511
A078900

Feb
Mar
Oct
Jul
Feb
Dec
Jun
Dec
Aug
Dec
Dec

1MG

N020788 001

Dec 19, 1997

5MG

N020180 001

Jun 19, 1992

0.5MG

N022527 001

Sep 21, 2010

TABLET; ORAL
FLAVOXATE HYDROCHLORIDE
EPIC PHARMA
100MG
AB
IMPAX PHARMS
100MG
AB
100MG
AB + PADDOCK LLC

A076835 001
A076234 001
A076831 001

Nov 30, 2005

Aug 28, 2003
Dec 16, 2004

FIDAXOMICIN
TABLET; ORAL
DIFICID
XX + OPTIMER PHARMS

FINASTERIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
FINASTERIDE
ACCORD HLTHCARE INC
ACTAVIS TOTOWA
AUROBINDO PHARMA
DR REDDYS LABS INC
DR REDDYS LABS LTD
GEDEON RICHTER USA
HETERO DRUGS LTD
MYLAN
SUN PHARMA GLOBAL
TEVA
ZYDUS PHARMS USA INC
PROPECIA
+ MERCK
PROSCAR
+ MERCK

001
001
001
001
001
001
001
001
001
001
001

23,
28,
30,
28,
28,
22,
07,
18,
16,
15,
28,

2010
2007
2007
2006
2007
2006
2010
2006
2011
2006
2009

FINGOLIMOD
CAPSULE; ORAL

GILENYA

XX + NOVARTIS

FLAVOXATE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 181 (of 424)

FLECAINIDE ACETATE
TABLET; ORAL
FLECAINIDE ACETATE
AMNEAL PHARM
AB
AB
AB
APOTEX INC
AB
AB
AB
BARR
AB
AB
AB
RANBAXY
AB
AB
AB
ROXANE
AB
AB
AB
TAMBOCOR
MEDICIS
AB
AB
AB +

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jul
Jul
Jul
Jul
Jul
Jul
Oct
Oct
Oct
Mar
Mar
Mar
Jan
Jan
Jan

31,
31,
31,
09,
09,
09,
28,
28,
28,
28,
28,
28,
14,
14,
14,

2001
2001
2001
2009
2009
2009
2002
2002
2002
2003
2003
2003
2003
2003
2003

50MG
100MG
150MG
50MG
100MG
150MG
50MG
100MG
150MG
50MG
100MG
150MG
50MG
100MG
150MG

A075442
A075442
A075442
A079164
A079164
A079164
A075882
A075882
A075882
A076421
A076421
A076421
A076278
A076278
A076278

50MG
100MG
150MG

N018830 004
N018830 001
N018830 003

Aug 23, 1988

Oct 31, 1985
Jun 03, 1988

500MG/VIAL
500MG/VIAL

A075837 001
A075387 001

Feb 22, 2001

Apr 16, 2000

50MG/5ML
200MG/5ML

N020090 001
N020090 002

Dec 23, 1993

Dec 23, 1993

50MG/5ML
200MG/5ML
50MG/5ML
200MG/5ML
50MG/5ML
200MG/5ML
50MG/5ML
200MG/5ML
50MG/5ML
200MG/5ML

A079150
A079150
A077523
A077523
A076332
A076332
A076246
A076246
A076918
A076918

Sep
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Dec
Dec

FLOXURIDINE
INJECTABLE; INJECTION
FLOXURIDINE
APP PHARMS
AP
AP + BEDFORD

FLUCONAZOLE
FOR SUSPENSION; ORAL
DIFLUCAN
PFIZER
AB
AB +
FLUCONAZOLE
AUROBINDO PHARM
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
RANBAXY
AB
AB
ROXANE
AB
AB
TARO PHARM INDS
AB
AB

AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
+ PFIZER
200MG/100ML (2MG/ML)
+
400MG/200ML (2MG/ML)
DIFLUCAN IN SODIUM CHLORIDE 0.9%
+ PFIZER
200MG/100ML (2MG/ML)
+
400MG/200ML (2MG/ML)
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
+ PFIZER
200MG/100ML (2MG/ML)
+
400MG/200ML (2MG/ML)
FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ACS DOBFAR INFO SA
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
APOTEX INC
200MG/100ML (2MG/ML)

001
002
001
002
001
002
001
002
001
002

18,
18,
12,
12,
29,
29,
29,
29,
18,
18,

2009
2009
2007
2007
2004
2004
2004
2004
2006
2006

N019950 003
N019950 005

Sep 29, 1992

Jul 08, 1994

N019950 001
N019950 006

Jan 29, 1990

Jan 29, 1990

N019950 002
N019950 004

Jan 29, 1990

Jan 29, 1990

A079104 001
A079104 002

Jul 30, 2009

Jul 30, 2009

A076888 001

Mar 25, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 182 (of 424)

FLUCONAZOLE
INJECTABLE; INJECTION
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
APOTEX INC
AP
400MG/200ML (2MG/ML)
HOSPIRA
AP
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
APP PHARMS
AP
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
BEDFORD
AP
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
CLARIS LIFESCIENCES
AP
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
HIKMA FARMACEUTICA
AP
200MG/100ML (2MG/ML)
TEVA PARENTERAL
AP
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE
AP
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
BEDFORD LABS
AP
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
CLARIS LIFESCIENCES
AP
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
HOSPIRA
AP
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
TEVA PARENTERAL
AP
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
FULCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
CLARIS LIFESCIENCES
AP
200MG/100ML (2MG/ML)
AP
400MG/200ML (2MG/ML)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
BEDFORD
100MG/50ML (2MG/ML)
XX
TABLET; ORAL
DIFLUCAN
PFIZER
AB
AB
AB
AB +
FLUCONAZOLE
AMNEAL PHARM
AB
AB
AB
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

A076888 002
A076304 001
A076304 002

Mar 25, 2005

Jul 29, 2004
Jul 29, 2004

A076145
A076145
A076087
A076087
A077947
A077947
A076736
A076653
A076653

001
002
001
003
001
002
001
001
002

Jul
Jul
Jul
Jul
May
May
Aug
Jul
Jul

29,
29,
29,
29,
26,
26,
23,
29,
29,

2004
2004
2004
2004
2010
2010
2005
2004
2004

A076766
A076766
A078107
A078107
A077909
A077909
A076303
A076303
A076837
A076837

001
002
001
002
001
002
001
002
001
002

Jul
Jul
Jul
Jul
May
May
Jul
Jul
Jan
Jan

29,
29,
30,
30,
26,
26,
29,
29,
13,
13,

2004
2004
2008
2008
2010
2010
2004
2004
2005
2005

A077988 001
A077988 002

May 26, 2010

May 26, 2010

A076087 002

Sep 26, 2008

50MG
100MG
150MG
200MG

N019949
N019949
N019949
N019949

001
002
004
003

Jan
Jan
Jun
Jan

29,
29,
30,
29,

1990
1990
1994
1990

50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG

A078423
A078423
A078423
A078423
A076665
A076665
A076665
A076665
A077731
A077731
A077731
A077731
A077253
A077253
A077253
A077253
A076077
A076077
A076077
A076077
A076042

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001

Mar
Mar
Mar
Mar
Jul
Jul
Jul
Jul
Oct
Oct
Oct
Oct
Jan
Jan
Jan
Jan
Jul
Jul
Jul
Jul
Jul

07,
07,
07,
07,
29,
29,
29,
29,
07,
07,
07,
07,
25,
25,
25,
25,
29,
29,
29,
29,
29,

2011
2011
2011
2011
2004
2004
2004
2004
2008
2008
2008
2008
2006
2006
2006
2006
2004
2004
2004
2004
2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 183 (of 424)

FLUCONAZOLE
TABLET; ORAL
FLUCONAZOLE
MYLAN
AB
AB
AB
AB
AB
AB
AB
RANBAXY
AB
AB
AB
AB
TARO
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
UNIQUE PHARM LABS
AB
AB
AB
FLUCONAZOLE
BX
DR REDDYS LABS INC
BX
BX
BX
BX
PLIVA
BX
BX
BX

50MG
100MG
100MG
150MG
150MG
200MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG
50MG
100MG
200MG

A076351
A076042
A076351
A076042
A076351
A076042
A076351
A076386
A076386
A076386
A076386
A076507
A076507
A076507
A076507
A074681
A074681
A074681
A074681
A076957
A076957
A076957

001
002
002
003
003
004
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Sep
Sep
Sep

29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
28,
28,
28,

2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2005
2005
2005

50MG
100MG
150MG
200MG
50MG
100MG
150MG
200MG

A076658
A076658
A076658
A076658
A076424
A076424
A076424
A076424

001
002
003
004
001
002
003
004

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

29,
29,
29,
29,
29,
29,
29,
29,

2004
2004
2004
2004
2004
2004
2004
2004

250MG
500MG

N017001 001
N017001 002

250MG
500MG

A201566 001
A201566 002

Jun 28, 2011

Jun 28, 2011

50MG/VIAL

N020038 001

Apr 18, 1991

50MG/VIAL
50MG/2ML (25MG/ML)
50MG/VIAL
50MG/2ML (25MG/ML)
50MG/VIAL
50MG/2ML (25MG/ML)
50MG/2ML (25MG/ML)
50MG/VIAL
50MG/2ML (25MG/ML)

A078610
A078393
A078544
A090724
A077790
A200647
N022137
A076349
A076661

Feb
Oct
Oct
Sep
Apr
Dec
Sep
Aug
Apr

FLUCYTOSINE
CAPSULE; ORAL
ANCOBON
VALEANT
AB
AB +
FLUCYTOSINE
SIGMAPHARM LABS LLC
AB
AB

FLUDARABINE PHOSPHATE
INJECTABLE; INJECTION
FLUDARA
AP + GENZYME
FLUDARABINE PHOSPHATE
ACTAVIS TOTOWA
AP
APP PHARMS
AP
AP
BIONICHE PHARMA USA
AP
HOSPIRA
AP
ONCO THERAPIES LTD
AP
AP + SANDOZ
TEVA PARENTERAL
AP
AP +

001
001
001
001
001
001
001
001
001

11,
15,
15,
27,
06,
21,
21,
28,
28,

2009
2007
2007
2010
2007
2011
2007
2003
2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 184 (of 424)

FLUDARABINE PHOSPHATE
TABLET; ORAL

OFORTA

XX + SANOFI AVENTIS US

10MG

N022273 001

Dec 18, 2008

20-200mCi/ML
20-200mCi/ML

N021870 001
A079086 001

Aug 19, 2005

Feb 25, 2011

10-100mCi/ML

N021768 001

Aug 05, 2004

20-300mCi/ML

N021870 002

Nov 21, 2008

A040425 001
A040431 001
A091302 001

Jan 21, 2003

Mar 18, 2002
Jul 22, 2011

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

A076955
A076955
A076787
A076787
A076256
A076256
A076755
A076755
A078527
A078527
A078595
A078595
A077071
A077071
A076589
A076589

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Mar
Mar
May
May
May
May
Oct
Oct

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

N020073 001
N020073 002

Dec 20, 1991

Dec 20, 1991

AEROSOL, METERED; INHALATION

AEROBID

0.25MG/INH
XX + ROCHE PALO
AEROSPAN HFA
EQ 78MCG BASE/INH
XX + ACTON PHARMS

N018340 001

Aug 17, 1984

N021247 001

Jan 27, 2006

SPRAY, METERED; NASAL

FLUNISOLIDE
AB + BAUSCH AND LOMB
HH AND P
AB
FLUNISOLIDE
XX + APOTEX INC

0.025MG/SPRAY
0.025MG/SPRAY

A074805 001
A077704 001

Feb 20, 2002

Aug 03, 2006

0.029MG/SPRAY

A077436 001

Aug 09, 2007

FLUDEOXYGLUCOSE F-18

AP
AP
XX
XX

INJECTABLE; INTRAVENOUS
FLUDEOXYGLUCOSE F18
+ FEINSTEIN
PETNET
FLUDEOXYGLUCOSE F 18
+ WEILL MEDCL COLL
FLUDEOXYGLUCOSE F18
+ FEINSTEIN

FLUDROCORTISONE ACETATE
TABLET; ORAL
FLUDROCORTISONE ACETATE
BARR
AB
0.1MG
AB + IMPAX LABS
0.1MG
WEST-WARD PHARM CORP 0.1MG
AB

FLUMAZENIL
INJECTABLE; INJECTION
FLUMAZENIL
APP PHARMS
AP
AP
BAXTER HLTHCARE
AP
AP
BEDFORD LABS
AP
AP
CLARIS LIFESCIENCES
AP
AP
HIKMA FARMACEUTICA
AP
AP
PFIZER
AP
AP
SANDOZ
AP
AP
TEVA PARENTERAL
AP
AP
ROMAZICON
AP + HOFFMANN LA ROCHE
AP

002
001
002
001
002
001
002
001
001
002
001
002
002
001
002
001

12,
12,
12,
12,
12,
12,
12,
12,
23,
23,
13,
13,
03,
03,
12,
12,

2004
2004
2004
2004
2004
2004
2004
2004
2009
2009
2008
2008
2005
2005
2004
2004

FLUNISOLIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 185 (of 424)

FLUOCINOLONE ACETONIDE
CREAM; TOPICAL
FLUOCINOLONE ACETONIDE
FOUGERA
AT
AT
G AND W LABS
AT
AT
TARO
AT
SYNALAR
AT + MEDIMETRIKS PHARMS
AT +
AT +

0.01%
0.025%
0.01%
0.025%
0.025%

A088170
A088169
A089526
A089525
A087104

0.01%
0.025%
0.025%

N012787 004
N012787 002
N012787 005

IMPLANT; INTRAVITREAL

RETISERT

XX + BAUSCH AND LOMB

0.59MG

N021737 001

Apr 08, 2005

0.01%
0.01%

N019452 001
N019452 002

Feb 03, 1988

Nov 09, 2005

0.01%
0.01%

A201759 001
A201764 001

Oct 17, 2011

Oct 17, 2011

0.01%

N019452 003

Nov 09, 2005

0.1%

A091306 001

Oct 17, 2011

0.025%
0.025%
0.025%

A088168 001
A089524 001
A040041 001

Dec 16, 1982

Jul 26, 1988
Sep 15, 1994

0.025%

N013960 001

0.01%

N020001 001

Aug 27, 1990

0.01%
0.01%

A088167 001
A089124 001

Dec 16, 1982

Sep 11, 1985

0.01%

N015296 001

OIL; TOPICAL
DERMA-SMOOTHE/FS
AT + HILL DERMAC
AT +
FLUOCINOLONE ACETONIDE
IDENTI PHARMS INC
AT
AT
OIL/DROPS; OTIC
DERMOTIC
AT + HILL DERMAC
FLUOCINOLONE ACETONIDE
IDENTI PHARMS INC
AT

AT
AT
AT
AT

OINTMENT; TOPICAL
FLUOCINOLONE ACETONIDE
FOUGERA
G AND W LABS
TARO
SYNALAR
+ MEDIMETRIKS PHARMS

SHAMPOO; TOPICAL

CAPEX

XX + GALDERMA LABS LP
SOLUTION; TOPICAL
FLUOCINOLONE ACETONIDE
FOUGERA
AT
TARO
AT
SYNALAR
AT + MEDIMETRIKS PHARMS

001
001
001
001
001

Dec
Dec
Jul
Jul
Apr

16,
16,
26,
26,
27,

1982
1982
1988
1988
1982

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

CREAM; TOPICAL

TRI-LUMA

XX + GALDERMA LABS LP

0.01%;4%;0.05%

N021112 001

Jan 18, 2002

0.05%
0.05%
0.05%
0.05%

A073085
A073030
N019117
A072488

Feb
Oct
Jun
Feb

0.05%

N016908 002

FLUOCINONIDE
CREAM; TOPICAL
FLUOCINONIDE
ACTAVIS MID ATLANTIC
AB1
FOUGERA
AB1
TARO
AB1
TEVA
AB1
LIDEX
AB1 + MEDICIS

001
001
001
001

14,
17,
26,
06,

1992
1994
1984
1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 186 (of 424)

FLUOCINONIDE
CREAM; TOPICAL
FLUOCINONIDE EMULSIFIED BASE
ALTANA
AB2
0.05%
TARO
AB2
0.05%
TEVA
AB2
0.05%
LIDEX-E
AB2 + MEDICIS
0.05%
VANOS
0.1%
XX + MEDICIS

AB
AB
AB
AB

AB
AB
AB
AB

AT
AT
AT
AT
AT

GEL; TOPICAL
FLUOCINONIDE
FOUGERA
TARO
TEVA
LIDEX
+ MEDICIS
OINTMENT; TOPICAL
FLUOCINONIDE
ALTANA
TARO
TEVA
LIDEX
+ MEDICIS
SOLUTION; TOPICAL
FLUOCINONIDE
ACTAVIS MID ATLANTIC
FOUGERA
TARO
TEVA
LIDEX
+ MEDICIS

A076586 001
A072494 001
A072490 001

Jun 23, 2004

Jan 19, 1989
Feb 07, 1989

N016908 003
N021758 001

Feb 11, 2005

0.05%
0.05%
0.05%

A072933 001
A074935 001
A072537 001

Dec 30, 1994

Jul 29, 1997
Feb 07, 1989

0.05%

N017373 001

0.05%
0.05%
0.05%

A074905 001
A075008 001
A073481 001

0.05%

N016909 002

0.05%
0.05%
0.05%
0.05%

A071535
A072934
A074799
A072511

0.05%

N018849 001

Apr 06, 1984

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

N022186 001

Aug 08, 2008

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

N021980 001

Mar 28, 2006

0.1%

N017760 001

Sep 04, 1985

N016851 002

Jul 28, 1982

N019216 001

Apr 23, 1986

N019079 001

Feb 11, 1986

001
001
001
001

Aug 26, 1997

Jun 30, 1999
Dec 27, 1991

Dec
Feb
Dec
Feb

02,
27,
31,
07,

1988
1995
1996
1989

FLUORESCEIN SODIUM
INJECTABLE; INTRAVENOUS
AK-FLUOR 10%
AKORN
AP
FLUORESCITE
AP + ALCON PHARMS LTD

FLUOROMETHOLONE
OINTMENT; OPHTHALMIC

FML

XX + ALLERGAN

SUSPENSION/DROPS; OPHTHALMIC

FML

0.1%
XX + ALLERGAN
FML FORTE
ALLERGAN
0.25%
XX

FLUOROMETHOLONE ACETATE
SUSPENSION/DROPS; OPHTHALMIC

FLAREX

XX + ALCON
0.1%

FLUOROURACIL
CREAM; TOPICAL

EFUDEX

AB + VALEANT PHARM INTL

5%

N016831 003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 187 (of 424)

FLUOROURACIL

AB
AB
XX
XX

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

CREAM; TOPICAL
FLUOROURACIL
SPEAR PHARMS
TARO
CARAC
+ SANOFI AVENTIS US
FLUOROPLEX
+ ALLERGAN HERBERT
INJECTABLE; INJECTION
FLUOROURACIL
+ APP PHARMS
+
+
+
+ BIONICHE PHARMA
+
+
+
EBEWE PHARMA
SANDOZ
+
+
+

TEVA PARENTERAL

SOLUTION; TOPICAL
EFUDEX
AT + VALEANT PHARM INTL
AT +
FLUOROURACIL
TARO
AT
AT

5%
5%

A077524 001
A090368 001

Apr 11, 2008

Mar 05, 2010

0.5%

N020985 001

Oct 27, 2000

1%

N016988 001

500MG/10ML (50MG/ML)
1GM/20ML (50MG/ML)
2.5GM/50ML (50MG/ML)
5GM/100ML (50MG/ML)
500MG/10ML (50MG/ML)
1GM/20ML (50MG/ML)
2.5GM/50ML (50MG/ML)
5GM/100ML (50MG/ML)
500MG/10ML (50MG/ML)
2.5GM/50ML (50MG/ML)
5GM/100ML (50MG/ML)
500MG/10ML (50MG/ML)
2.5GM/50ML (50MG/ML)
5GM/100ML (50MG/ML)

A040279
A040279
A040278
A040278
A040743
A040743
A040798
A040798
A040772
A091299
A091299
A040333
A040334
A040334

2%
5%

N016831 001
N016831 002

2%
5%

A076526 001
A076526 002

Nov 05, 2003

Nov 05, 2003

A090223
A078619
A075465
A075245
A075207
A076990
A075049
A075452
A078143

Mar
Jan
Aug
Sep
May
Dec
Jan
Jan
Jan

002
001
001
002
002
001
002
001
001
001
002
001
001
002

Sep
Sep
Sep
Sep
Apr
Apr
Apr
Apr
Aug
May
May
Jan
Feb
Feb

30,
30,
30,
30,
26,
26,
26,
26,
11,
02,
02,
27,
25,
25,

1998
1998
1998
1998
2007
2007
2007
2007
2008
2011
2011
2000
2000
2000

FLUOXETINE HYDROCHLORIDE
CAPSULE; ORAL
FLUOXETINE HYDROCHLORIDE
ALEMBIC PHARMS LTD
AB
EQ
AUROBINDO PHARMA
AB
EQ
DR REDDYS LABS INC
AB
EQ
IVAX SUB TEVA PHARMS EQ
AB
MYLAN
AB
EQ
RANBAXY
AB
EQ
SANDOZ
AB
EQ
TEVA
AB
EQ
WOCKHARDT
AB
EQ
PROZAC
AB + LILLY
EQ
FLUOXETINE HYDROCHLORIDE
ALEMBIC PHARMS LTD
AB1
EQ
AB1
EQ
ALPHAPHARM
AB1
EQ
AB1
EQ
AUROBINDO PHARMA
AB1
EQ
AB1
EQ
BARR
AB1
EQ
AB1
EQ
BEIJING DOUBLE CRANE EQ
AB1
AB1
EQ
CARLSBAD
AB1
EQ
AB1
EQ

40MG
40MG
40MG
40MG
40MG
40MG
40MG
40MG
40MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

003
003
003
003
003
001
003
003
003

19,
31,
02,
28,
25,
13,
29,
29,
16,

2009
2008
2001
2004
2007
2004
2002
2002
2008

40MG BASE

N018936 003

Jun 15, 1999

10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG

A090223
A090223
A075577
A075577
A078619
A078619
A074803
A074803
A076165
A076165
A076022
A076022

Mar
Mar
Jan
Jan
Jan
Jan
Jan
Aug
Feb
Feb
Jan
Jan

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
002
001
002
001
002
002
001
001
002
001
002

19,
19,
29,
29,
31,
31,
30,
02,
01,
01,
30,
30,

2009
2009
2002
2002
2008
2008
2002
2001
2002
2002
2002
2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 188 (of 424)

FLUOXETINE HYDROCHLORIDE
CAPSULE; ORAL
FLUOXETINE HYDROCHLORIDE
DR REDDYS LABS INC
AB1
EQ
AB1
EQ
IVAX SUB TEVA PHARMS EQ
AB1
AB1
EQ
LANDELA PHARM
AB1
EQ
AB1
EQ
MALLINCKRODT
AB1
EQ
AB1
EQ
MYLAN
AB1
EQ
AB1
EQ
PLIVA
AB1
EQ
AB1
EQ
SANDOZ
AB1
EQ
AB1
EQ
TEVA
AB1
EQ
AB1
EQ
WOCKHARDT
AB1
EQ
AB1
EQ
PROZAC
LILLY
AB1
EQ
AB1
EQ
FLUOXETINE HYDROCHLORIDE
MYLAN
AB2
EQ
AB2
EQ
SANDOZ
AB2
EQ
AB2
EQ
TEVA
AB2
EQ
AB2
EQ
SARAFEM
LILLY
AB2
EQ
AB2 +
EQ

10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A075465
A075465
A075245
A075245
A075464
A075464
A075658
A075658
A075207
A075207
A076001
A076001
A075049
A075049
A075452
A075452
A078143
A078143

001
002
002
001
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Aug
Jan
Jan
Jan
Jan
Jan

29,
29,
31,
31,
30,
30,
29,
29,
30,
30,
29,
29,
02,
29,
29,
29,
16,
16,

2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2001
2002
2002
2002
2008
2008

10MG BASE
20MG BASE

N018936 006
N018936 001

Dec 23, 1992

Dec 29, 1987

10MG
20MG
10MG
20MG
10MG
20MG

A078045
A078045
A077469
A077469
A076287
A076287

Nov
Nov
Nov
Nov
May
May

BASE
BASE
BASE
BASE
BASE
BASE

001
002
001
002
001
002

17,
17,
17,
17,
20,
20,

2008
2008
2008
2008
2008
2008

10MG BASE
20MG BASE

N018936 007
N018936 008

Jul 06, 2000

Jul 06, 2000

CAPSULE, DELAYED REL PELLETS; ORAL

FLUOXETINE HYDROCHLORIDE
BARR
AB
EQ 90MG BASE
DR REDDYS LABS LTD
AB
EQ 90MG BASE
PROZAC WEEKLY
AB + LILLY
EQ 90MG BASE

A076237 001
A078572 001

Mar 24, 2010

Mar 22, 2010

N021235 001

Feb 26, 2001

A079209
A076458
A075920
A075292
A076015
A077849
A075506
A075514

Mar
May
Jan
Feb
Jan
Feb
Aug
Aug

AA
AA
AA
AA
AA
AA
AA
AA

AB
AB
AB
XX
XX
XX

SOLUTION; ORAL
FLUOXETINE HYDROCHLORIDE
AUROBINDO PHARM
EQ
LANNETT
EQ
MALLINCKRODT
EQ
NOVEX
EQ
+ PHARM ASSOC
EQ
SILARX
EQ
TEVA
EQ
WOCKHARDT
EQ
TABLET; ORAL
FLUOXETINE HYDROCHLORIDE
DR REDDYS LABS INC
EQ
MYLAN
EQ
TEVA
EQ
FLUOXETINE HYDROCHLORIDE
EDGEMONT PHARMS LLC
EQ
+ MYLAN
EQ
SARAFEM
WARNER CHILCOTT
EQ

20MG
20MG
20MG
20MG
20MG
20MG
20MG
20MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

001
001
001
001
001
001
001
001

20,
14,
29,
07,
30,
09,
02,
29,

2009
2004
2002
2002
2002
2007
2001
2002

10MG BASE
10MG BASE
10MG BASE

A076006 001
A075755 001
A075872 001

Jan 30, 2002

Aug 02, 2001
Jan 29, 2002

60MG BASE
20MG BASE

N202133 001
A075755 002

Oct 06, 2011

Aug 02, 2001

10MG BASE

N021860 001

May 19, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 189 (of 424)

FLUOXETINE HYDROCHLORIDE
TABLET; ORAL
SARAFEM
WARNER CHILCOTT
XX
XX +

EQ 15MG BASE
EQ 20MG BASE

N021860 002
N021860 003

May 19, 2006

May 19, 2006

N021520
N021520
N021520
N021520
N021520

Apr
Dec
Dec
Dec
Dec

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

CAPSULE; ORAL
SYMBYAX
LILLY
XX
XX
XX
XX +
XX

EQ
EQ
EQ
EQ
EQ

25MG
25MG
25MG
50MG
50MG

BASE;EQ
BASE;EQ
BASE;EQ
BASE;EQ
BASE;EQ

3MG BASE
6MG BASE
12MG BASE
6MG BASE
12MG BASE

001
002
004
003
005

09,
24,
24,
24,
24,

2007
2003
2003
2003
2003

FLUOXYMESTERONE
TABLET; ORAL

FLUOXYMESTERONE

XX + USL PHARMA

10MG

A088342 001

Oct 21, 1983

25MG/ML
25MG/ML
25MG/ML

A071413 001
A074531 001
A075918 001

Jul 14, 1987

Aug 30, 1996
Aug 17, 2001

CONCENTRATE; ORAL

FLUPHENAZINE HYDROCHLORIDE

5MG/ML
XX + PHARM ASSOC

A074725 001

Sep 16, 1996

ELIXIR; ORAL

FLUPHENAZINE HYDROCHLORIDE

2.5MG/5ML
XX + PHARM ASSOC

A040146 001

Aug 21, 1996

INJECTABLE; INJECTION

FLUPHENAZINE HYDROCHLORIDE

2.5MG/ML
XX + APP PHARMS

A089556 001

Apr 16, 1987

TABLET; ORAL
FLUPHENAZINE HYDROCHLORIDE
LANNETT
AB
1MG
AB
2.5MG
AB
5MG
AB
10MG
MYLAN
AB
1MG
AB
2.5MG
AB
5MG
AB +
10MG
SANDOZ
AB
1MG
AB
2.5MG
AB
5MG
AB
10MG

A089740
A089741
A089742
A089743
A089804
A089804
A089804
A089804
A089583
A089584
A089585
A089586

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Oct
Oct
Oct
Oct

FLUPHENAZINE DECANOATE
INJECTABLE; INJECTION
FLUPHENAZINE DECANOATE
AO + APP PHARMS
BEDFORD
AO
CLARIS LIFESCIENCES
AO

FLUPHENAZINE HYDROCHLORIDE

001
001
001
001
002
003
004
001
001
001
001
001

FLURANDRENOLIDE
CREAM; TOPICAL
CORDRAN SP
WATSON PHARMS
XX

0.025%

N012806 003

25,
25,
25,
25,
12,
12,
12,
12,
16,
16,
16,
16,

1988
1988
1988
1988
1988
1988
1988
1988
1987
1987
1987
1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 190 (of 424)

FLURANDRENOLIDE
LOTION; TOPICAL

CORDRAN

XX + WATSON LABS

0.05%

N013790 001

TAPE; TOPICAL

CORDRAN

XX + WATSON PHARMS

0.004MG/SQ CM

N016455 001

FLURAZEPAM HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
FLURAZEPAM HYDROCHLORIDE
MYLAN PHARMS INC
15MG
+
30MG
WATSON LABS
15MG
30MG
30MG
WEST WARD
15MG
30MG

A070345
A070345
A071205
A071068
A072369
A071107
A071108

002
001
001
001
001
001
001

Nov
Nov
Nov
Nov
Mar
Dec
Dec

27,
27,
25,
25,
30,
08,
08,

1985
1985
1986
1986
1989
1986
1986

FLURBIPROFEN
TABLET; ORAL
ANSAID
PHARMACIA AND UPJOHN
AB
AB +
FLURBIPROFEN
CARACO
AB
AB
MYLAN
AB
AB
TEVA
AB

50MG
100MG

N018766 002
N018766 003

Oct 31, 1988

Oct 31, 1988

50MG
100MG
50MG
100MG
100MG

A075058
A075058
A074358
A074358
A074431

Apr
Apr
Jun
Jun
May

001
002
001
002
001

27,
27,
20,
20,
31,

2001
2001
1994
1994
1995

FLURBIPROFEN SODIUM
SOLUTION/DROPS; OPHTHALMIC
FLURBIPROFEN SODIUM
BAUSCH AND LOMB
AT
0.03%
OCUFEN
AT + ALLERGAN
0.03%

A074447 001

Jan 04, 1995

N019404 001

Dec 31, 1986

125MG
125MG
125MG
125MG
125MG

A075780
A076224
A075298
A075818
A075820

Sep
May
Sep
Sep
Sep

0.0275MG/INH

N022051 001

Apr 27, 2007

N021433 003
N021433 002
N021433 001

May 14, 2004

May 14, 2004
May 14, 2004

FLUTAMIDE

AB
AB
AB
AB
AB

CAPSULE; ORAL
FLUTAMIDE
IVAX SUB TEVA PHARMS
MYLAN
PAR PHARM
+ SANDOZ
WATSON LABS

001
001
001
001
001

19,
09,
18,
18,
18,

2001
2003
2001
2001
2001

FLUTICASONE FUROATE
SPRAY, METERED; NASAL

VERAMYST

XX + GLAXOSMITHKLINE

FLUTICASONE PROPIONATE
AEROSOL, METERED; INHALATION
FLOVENT HFA
0.044MG/INH
XX + GLAXO GRP LTD
0.11MG/INH
XX +
0.22MG/INH
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 191 (of 424)

FLUTICASONE PROPIONATE

AB
AB
AB
AB
AB
AB

CREAM; TOPICAL
CUTIVATE
+ ALTANA
FLUTICASONE PROPIONATE
ALTANA
G AND W LABS
NESHER PHARMS
PERRIGO NEW YORK
TOLMAR

LOTION; TOPICAL
CUTIVATE
AB + FOUGERA PHARMS
FLUTICASONE PROPIONATE
GLENMARK GENERICS
AB

AB
AB
AB
AB

OINTMENT; TOPICAL
CUTIVATE
+ FOUGERA PHARMS
FLUTICASONE PROPIONATE
ALTANA
G AND W LABS
PERRIGO NEW YORK

POWDER; INHALATION

FLOVENT DISKUS 100

XX + GLAXOSMITHKLINE
FLOVENT DISKUS 250
XX + GLAXOSMITHKLINE
FLOVENT DISKUS 50
XX + GLAXOSMITHKLINE

AB
AB
AB
AB
AB

SPRAY, METERED; NASAL

FLONASE
+ GLAXOSMITHKLINE
FLUTICASONE PROPIONATE
APOTEX INC
HI TECH PHARMA
ROXANE
WOCKHARDT

0.05%

N019958 001

Dec 18, 1990

0.05%
0.05%
0.05%
0.05%
0.05%

A076451
A077055
A076865
A076793
A076633

May
Jun
Sep
May
May

0.05%

N021152 001

Mar 31, 2005

0.05%

A090759 001

May 02, 2011

0.005%

N019957 001

Dec 14, 1990

0.005%
0.005%
0.005%

A076300 001
A077168 001
A076668 001

May 14, 2004

Mar 03, 2006
May 14, 2004

0.1MG/INH

N020833 002

Sep 29, 2000

0.25MG/INH

N020833 003

Sep 29, 2000

0.05MG/INH

N020833 001

Sep 29, 2000

0.05MG/SPRAY

N020121 001

Oct 19, 1994

0.05MG/SPRAY
0.05MG/SPRAY
0.05MG/SPRAY
0.05MG/SPRAY

A077538
A077570
A076504
A078492

Sep
Jan
Feb
Jan

001
001
001
001
001

001
001
001
001

14,
30,
10,
14,
14,

12,
16,
22,
09,

2004
2006
2004
2004
2004

2007
2008
2006
2012

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

AEROSOL, METERED; INHALATION

ADVAIR HFA

0.045MG/INH;EQ 0.021MG BASE/INH

XX + GLAXOSMITHKLINE
0.115MG/INH;EQ 0.021MG BASE/INH
XX +
0.23MG/INH;EQ 0.021MG BASE/INH
XX +
POWDER; INHALATION

ADVAIR DISKUS 100/50

XX + GLAXOSMITHKLINE
ADVAIR DISKUS 250/50
XX + GLAXOSMITHKLINE
ADVAIR DISKUS 500/50
XX + GLAXOSMITHKLINE

N021254 001
N021254 002
N021254 003

Jun 08, 2006

Jun 08, 2006
Jun 08, 2006

0.1MG/INH;EQ 0.05MG BASE/INH

N021077 001

Aug 24, 2000

0.25MG/INH;EQ 0.05MG BASE/INH

N021077 002

Aug 24, 2000

0.5MG/INH;EQ 0.05MG BASE/INH

N021077 003

Aug 24, 2000

EQ 20MG BASE
EQ 40MG BASE

N020261 001
N020261 002

Dec 31, 1993

Dec 31, 1993

FLUVASTATIN SODIUM
CAPSULE; ORAL

LESCOL

NOVARTIS

XX
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 192 (of 424)

FLUVASTATIN SODIUM
TABLET, EXTENDED RELEASE; ORAL

LESCOL XL

80MG
XX + NOVARTIS

N021192 001

Oct 06, 2000

N022033 001
N022033 002

Feb 28, 2008

Feb 28, 2008

25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG

A075902
A075902
A075902
A075897
A075897
A075897
A075900
A075900
A075900
A075889
A075889
A075889
A075888
A075888
A075888
A075893
A075893
A075893

May
May
May
Jan
Jan
Jan
Feb
Feb
Feb
Nov
Nov
Nov
Nov
Nov
Nov
Sep
Sep
Sep

25MG
50MG
100MG

N021519 001
N021519 002
N021519 003

Dec 20, 2007

Dec 20, 2007
Dec 20, 2007

5MG/ML

A089202 001

Feb 18, 1986

1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG

A040625
A085061
A040796
A090035
A040514
A040756
A080680
A080600

001
001
001
001
001
001
001
001

Jul 21, 2005

Jan
Jun
Jun
Jun

12,
09,
14,
04,

2009
2009
2005
2010

75 IU/0.5ML
150 IU/0.5ML
300 IU/0.36ML
600 IU/0.72ML
900 IU/1.08ML

N021273
N021273
N021211
N021211
N021211

001
002
001
002
004

Aug
Aug
Mar
Mar
Feb

26,
26,
23,
23,
11,

2005
2005
2004
2004
2005

FLUVOXAMINE MALEATE
CAPSULE, EXTENDED RELEASE; ORAL
LUVOX CR
JAZZ
100MG
XX
150MG
XX +
TABLET; ORAL
FLUVOXAMINE MALEATE
APOTEX
AB
AB
AB
BARR
AB
AB
AB
CARACO
AB
AB
AB
MYLAN
AB
AB
AB
SANDOZ
AB
AB
AB +
TEVA
AB
AB
AB
LUVOX
ANI PHARMS
AB
AB
AB

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

07,
07,
07,
25,
25,
25,
23,
23,
23,
29,
29,
29,
29,
29,
29,
10,
10,
10,

2001
2001
2001
2001
2001
2001
2006
2006
2006
2000
2000
2000
2000
2000
2000
2002
2002
2002

FOLIC ACID
INJECTABLE; INJECTION

FOLIC ACID

XX + APP PHARMS

AA
AA
AA
AA
AA
AA
AA
AA

TABLET; ORAL
FOLIC ACID
+ AMNEAL PHARM
CONTRACT PHARMACAL
EXCELLIUM
INVAGEN PHARMS
JUBILANT CADISTA
VINTAGE
+ WATSON LABS
WEST WARD

FOLLITROPIN ALFA/BETA

XX
XX
XX
XX
XX

INJECTABLE; SUBCUTANEOUS
FOLLISTIM AQ
+ ORGANON USA INC
+
+
+
+

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 193 (of 424)

FOLLITROPIN ALFA/BETA
INJECTABLE; SUBCUTANEOUS

GONAL-F

XX + EMD SERONO
XX
GONAL-F RFF
XX + EMD SERONO
GONAL-F RFF PEN
XX + EMD SERONO
XX +
XX +

450 IU/VIAL
1,050 IU/VIAL

N020378 005
N020378 004

Mar 26, 2004

Feb 28, 2001

75 IU/VIAL

N021765 002

Mar 25, 2004

300 IU/0.5ML
450 IU/0.75ML
900 IU/1.5ML

N021684 001
N021684 002
N021684 003

May 25, 2004

May 25, 2004
May 25, 2004

1.5GM/1.5ML (1GM/ML)

N020696 001

Dec 04, 1997

1.5GM/1.5ML
1.5GM/1.5ML
1.5GM/1.5ML
1.5GM/1.5ML

A079033
A078368
A078537
A078639

001
001
001
001

Apr
Dec
Mar
Mar

07,
14,
06,
03,

2009
2007
2008
2008

2.5MG/0.5ML
5MG/0.4ML
7.5MG/0.6ML
10MG/0.8ML

N021345
N021345
N021345
N021345

001
002
003
004

Dec
May
May
May

07,
28,
28,
28,

2001
2004
2004
2004

2.5MG/0.5ML
5MG/0.4ML
7.5MG/0.6ML
10MG/0.8ML

A091316
A091316
A091316
A091316

001
002
003
004

Jul
Jul
Jul
Jul

11,
11,
11,
11,

2011
2011
2011
2011

POWDER; INHALATION

FORADIL

XX + NOVARTIS

0.012MG/INH

N020831 001

Feb 16, 2001

SOLUTION; INHALATION

PERFOROMIST

XX + DEY PHARMA

0.02MG/2ML

N022007 001

May 11, 2007

N022518 001
N022518 002

Jun 22, 2010

Jun 22, 2010

FOMEPIZOLE

AP
AP
AP
AP
AP

INJECTABLE; INJECTION
ANTIZOL
+ PALADIN LABS
FOMEPIZOLE
BIONICHE PHARMA USA
LUITPOLD
NAVINTA LLC
SYNERX PHARMA

(1GM/ML)
(1GM/ML)
(1GM/ML)
(1GM/ML)

FONDAPARINUX SODIUM

AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; SUBCUTANEOUS
ARIXTRA
+ GLAXOSMITHKLINE
+
+
+
FONDAPARINUX SODIUM
DR REDDYS LABS LTD

FORMOTEROL FUMARATE

FORMOTEROL FUMARATE; MOMETASONE FUROATE

AEROSOL, METERED; INHALATION

DULERA

0.005MG/INH;0.1MG/INH
XX + SCHERING
0.005MG/INH;0.2MG/INH
XX +

FOSAMPRENAVIR CALCIUM
SUSPENSION; ORAL

LEXIVA

XX + VIIV HLTHCARE

EQ 50MG BASE/ML

N022116 001

Jun 14, 2007

TABLET; ORAL

LEXIVA

XX + VIIV HLTHCARE

EQ 700MG BASE

N021548 001

Oct 20, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 194 (of 424)

FOSAPREPITANT DIMEGLUMINE
POWDER; INTRAVENOUS

EMEND

XX + MERCK AND CO INC

XX +

EQ 115MG BASE/VIAL
EQ 150MG BASE/VIAL

N022023 001
N022023 002

Jan 25, 2008

Nov 12, 2010

2.4GM/100ML

A077174 001

May 31, 2005

2.4GM/100ML

N020068 001

Sep 27, 1991

EQ 3GM BASE/PACKET

N050717 001

Dec 19, 1996

10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
10MG
20MG
20MG
40MG
40MG
10MG
20MG
40MG

A076906
A076906
A076906
A091163
A091163
A091163
A077222
A077222
A077222
A076580
A076580
A076580
A076483
A076483
A076483
A076139
A076139
A076139
A076987
A077531
A076987
A077531
A076987
A077531
A076620
A076620
A076620

May
May
May
Mar
Mar
Mar
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Nov
Nov
Nov
Dec
Aug
Dec
Aug
Dec
Aug
Oct
Oct
Oct

10MG
20MG
40MG

N019915 002
N019915 003
N019915 004

May 16, 1991

May 16, 1991
Mar 28, 1995

A079245
A079245
A090228
A090228

Jul
Jul
Jul
Jul

FOSCARNET SODIUM
INJECTABLE; INJECTION
FOSCARNET SODIUM
HOSPIRA
AP
FOSCAVIR
AP + CLINIGEN HLTHCARE

FOSFOMYCIN TROMETHAMINE
FOR SUSPENSION; ORAL

MONUROL

XX + ZAMBON SPA

FOSINOPRIL SODIUM
TABLET; ORAL
FOSINOPRIL SODIUM
APOTEX INC
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
RANBAXY
AB
AB
AB
SANDOZ
AB
AB
AB
TEVA
AB
AB
AB +
WATSON LABS
AB
AB
AB
AB
AB
AB
WATSON LABS FLORIDA
AB
AB
AB
MONOPRIL
BRISTOL MYERS SQUIBB
AB
AB
AB +

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003

17,
17,
17,
30,
30,
30,
20,
20,
20,
23,
23,
23,
23,
23,
23,
25,
25,
25,
23,
31,
23,
31,
23,
31,
15,
15,
15,

2005
2005
2005
2011
2011
2011
2005
2005
2005
2004
2004
2004
2004
2004
2004
2003
2003
2003
2004
2006
2004
2006
2004
2006
2004
2004
2004

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

TABLET; ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
AUROBINDO PHARMA
10MG;12.5MG
AB
20MG;12.5MG
AB
INVAGEN PHARMS
10MG;12.5MG
AB
20MG;12.5MG
AB

001
002
001
002

09,
09,
09,
09,

2009
2009
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 195 (of 424)

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

TABLET; ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
MYLAN
10MG;12.5MG
AB
20MG;12.5MG
AB
RANBAXY
10MG;12.5MG
AB
20MG;12.5MG
AB
SANDOZ
10MG;12.5MG
AB
20MG;12.5MG
AB
WATSON LABS FLORIDA
10MG;12.5MG
AB
20MG;12.5MG
AB

A077705
A077705
A076739
A076739
A076961
A076961
A076608
A076608

001
002
001
002
001
002
001
002

Aug
Aug
Dec
Dec
Sep
Sep
Dec
Dec

14,
14,
17,
17,
28,
28,
03,
03,

2006
2006
2004
2004
2005
2005
2004
2004

FOSINOPRIL; HYDROCHLOROTHIAZIDE
TABLET; ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
EMCURE PHARMS USA
AB
10MG;12.5MG
AB
20MG;12.5MG

A079025 001
A079025 002

Sep 17, 2010

Sep 17, 2010

FOSPHENYTOIN SODIUM

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
FOSPHENYTOIN SODIUM
APOTEX INC
+ APP PHARMS
BAXTER HLTHCARE
BEDFORD
HIKMA FARMACEUTICA
HOSPIRA
LUITPOLD
PFIZER
STRIDES ARCOLAB
SUN PHARMA GLOBAL
TEVA PARENTERAL
WOCKHARDT

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG

PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PNENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN
PHENYTOIN

NA/ML
NA/ML
NA/ML
NA/ML
NA/ML
NA/ML
NA/ML
NA/ML
NA/ML
NA/ML
NA/ML
NA/ML
NA/ML

A078126
A078052
A077989
A077481
A078765
A078158
A078277
A090099
A078476
A078736
A078417
A076886
A078137

001
001
001
001
001
001
001
001
001
001
001
001
001

Aug
Aug
Aug
Aug
Dec
Aug
Aug
May
Mar
Jun
Mar
Aug
Aug

06,
06,
06,
06,
02,
06,
06,
13,
18,
08,
18,
06,
06,

2007
2007
2007
2007
2009
2007
2007
2010
2008
2010
2008
2007
2007

FOSPROPOFOL DISODIUM
SOLUTION; INTRAVENOUS

LUSEDRA

XX + EISAI INC

1050MG/30ML (35MG/ML)

N022244 001

Dec 12, 2008

EQ 2.5MG BASE

N021006 001

Nov 08, 2001

N021344 001

Apr 25, 2002

N018902
A070578
A075241
N018667
N018025
N018579

May
Jul
May
May

FROVATRIPTAN SUCCINATE
TABLET; ORAL

FROVA

XX + ENDO PHARMS

FULVESTRANT
INJECTABLE; INTRAMUSCULAR

FASLODEX

50MG/ML
XX + ASTRAZENECA

FUROSEMIDE
INJECTABLE; INJECTION
FUROSEMIDE
APP PHARMS
AP
HOSPIRA
AP
AP
AP
INTL MEDICATION
AP
AP + LUITPOLD

10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML

001
001
001
001
001
001

22,
08,
28,
28,

1984
1987
1999
1982

Nov 30, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 196 (of 424)

FUROSEMIDE
INJECTABLE; INJECTION
FUROSEMIDE
WOCKHARDT
AP
SOLUTION; ORAL
FUROSEMIDE
AA + ROXANE
WOCKHARDT
AA
FUROSEMIDE
ROXANE
XX
TABLET; ORAL
FUROSEMIDE
DAVA PHARMS INC
AB
AB
AB
EXCELLIUM
AB
AB
AB
IPCA LABS LTD
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
MYLAN
AB
AB
AB
ROXANE
AB
AB
AB
SANDOZ
AB
AB
AB
VINTAGE PHARMS
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
AB
AB
LASIX
SANOFI AVENTIS US
AB
AB
AB +

10MG/ML

A077941 001

Mar 22, 2007

10MG/ML
10MG/ML

A070434 001
A070655 001

Apr 22, 1987

Oct 02, 1987

40MG/5ML

A070433 001

Apr 22, 1987

20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG
20MG
20MG
20MG
40MG
80MG
80MG

N018415
N018415
N018415
A077293
A077293
A077293
A078010
A078010
A078010
N018413
N018413
N018487
N018487
A070082
N018823
N018823
A070086
N018569
N018569
N018569
A076796
A076796
A076796
A070412
A070449
A071379
A070450
A070528
A071594

Jul
Jul
Nov
Nov
Nov
Nov
Sep
Sep
Sep
Nov
Nov

27,
27,
26,
09,
09,
09,
18,
18,
18,
30,
30,

1982
1982
1984
2005
2005
2005
2006
2006
2006
1983
1983

Oct
Nov
Nov
Jan

29,
10,
10,
24,

1986
1983
1983
1986

Aug
Mar
Mar
Mar
Feb
Nov
Jan
Nov
Jan
Feb

14,
26,
26,
26,
26,
22,
02,
22,
07,
09,

1984
2004
2004
2004
1986
1985
1987
1985
1986
1988

20MG
40MG
80MG

N016273 002
N016273 001
N016273 003

100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG

A075350
A075350
A075350
A090858
A090858
A090858
A078428
A078428
A078428
A075360
A075360

Sep
Sep
Sep
Dec
Dec
Dec
Jul
Jul
Jul
Apr
Apr

12,
12,
12,
17,
17,
17,
25,
25,
25,
06,
06,

2003
2003
2003
2010
2010
2010
2007
2007
2007
2005
2005

001
002
003
001
002
003
001
002
003
001
002
001
002
001
001
002
001
002
001
005
001
002
003
001
001
001
001
001
001

GABAPENTIN
CAPSULE; ORAL
GABAPENTIN
ACTAVIS ELIZABETH
AB
AB
AB
ALKEM
AB
AB
AB
AMNEAL PHARMS NY
AB
AB
AB
APOTEX INC
AB
AB

001
002
003
001
002
003
001
002
003
001
002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 197 (of 424)

GABAPENTIN
CAPSULE; ORAL
GABAPENTIN
APOTEX INC
AB
AUROBINDO PHARM
AB
AB
AB
HIKMA
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
MARKSANS PHARMA
AB
AB
AB
MYLAN
AB
AB
AB
RANBAXY
AB
AB
AB
SUN PHARM INDS LTD
AB
AB
AB
TEVA PHARMS
AB
AB
AB
WATSON LABS
AB
AB
AB
NEURONTIN
PFIZER PHARMS
AB
AB
AB +

003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
003
002
001

Apr
Jan
Jan
Jan
Sep
Sep
Sep
Dec
Dec
Dec
Jul
Jul
Jul
Feb
Feb
Feb
Oct
Oct
Oct
Aug
Aug
Aug
Oct
Oct
Oct
May
May
May

06,
31,
31,
31,
25,
25,
25,
30,
30,
30,
21,
21,
21,
14,
14,
14,
07,
07,
07,
24,
24,
24,
08,
08,
08,
11,
11,
11,

2005
2008
2008
2008
2007
2007
2007
2009
2009
2009
2011
2011
2011
2011
2011
2011
2005
2005
2005
2006
2006
2006
2004
2004
2004
2007
2007
2007

400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG

A075360
A078787
A078787
A078787
A078150
A078150
A078150
A090705
A090705
A090705
A090007
A090007
A090007
A090158
A090158
A090158
A076606
A076606
A076606
A077242
A077242
A077242
A075435
A075435
A075435
A075485
A075485
A075485

100MG
300MG
400MG

N020235 001
N020235 002
N020235 003

Dec 30, 1993

Dec 30, 1993
Dec 30, 1993

SOLUTION; ORAL
GABAPENTIN
HI TECH PHARMA
AA
NEURONTIN
AA + PARKE DAVIS

250MG/5ML

A078974 001

Feb 18, 2011

250MG/5ML

N021129 001

Mar 02, 2000

TABLET; ORAL
GABAPENTIN
ACTAVIS ELIZABETH
AB
AB
APOTEX INC
AB
AB
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
GLENMARK GENERICS
AB
AB
HIKMA PHARMS
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
AB
AB

600MG
800MG
100MG
300MG
400MG
600MG
800MG
600MG
800MG
600MG
800MG
600MG
800MG
100MG
300MG
400MG
600MG
800MG

A075694
A075694
A077894
A077894
A077894
A077661
A077661
A200651
A200651
A077662
A077662
A078782
A078782
A076017
A076017
A076017
A076017
A076017

Oct
Oct
Oct
Oct
Oct
Sep
Sep
Oct
Oct
Aug
Aug
Jul
Jul
Apr
Apr
Apr
Apr
Apr

001
002
001
002
003
004
005
001
002
001
002
001
002
001
002
003
004
005

21,
21,
10,
10,
10,
13,
13,
06,
06,
18,
18,
21,
21,
28,
28,
28,
29,
29,

2004
2004
2006
2006
2006
2006
2006
2011
2011
2006
2006
2011
2011
2004
2004
2004
2005
2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 198 (of 424)

GABAPENTIN
TABLET; ORAL
GABAPENTIN
MATRIX LABS LTD
AB
AB
SUN PHARM INDS LTD
AB
AB
ZYDUS PHARMS USA INC
AB
AB
NEURONTIN
PFIZER PHARMS
AB
AB +
GRALISE
BX + DEPOMED INC
BX +

001
002
001
002
001
002

Jun
Jun
Aug
Aug
Feb
Feb

01,
01,
24,
24,
11,
11,

2010
2010
2006
2006
2011
2011

600MG
800MG
600MG
800MG
600MG
800MG

A090335
A090335
A077525
A077525
A078926
A078926

600MG
800MG

N020882 001
N020882 002

Oct 09, 1998

Oct 09, 1998

300MG
600MG

N022544 001
N022544 002

Jan 28, 2011

Jan 28, 2011

N022399 002
N022399 001

Dec 13, 2011

Apr 06, 2011

2.645GM/5ML (529MG/ML)
5.29GM/10ML (529MG/ML)
7.935GM/15ML (529MG/ML)
10.58GM/20ML (529MG/ML)

N021357
N021357
N021357
N021357

Nov
Nov
Nov
Nov

26.45GM/50ML (529MG/ML)
52.9GM/100ML (529MG/ML)

N021358 001
N021358 002

Nov 23, 2004

Nov 23, 2004

4.5354GM/7.5ML (604.72MG/ML)
6.0472GM/10ML (604.72MG/ML)
9.0708GM/15ML (604.72MG/ML)
18.1416GM/30ML (604.72MG/ML)
39.3068GM/65ML (604.72MG/ML)

N201277
N201277
N201277
N201277
N201277

Mar
Mar
Mar
Mar
Mar

287MG/ML
28.7GM/100ML (287MG/ML)

N020123 001
N022066 002

Jan 08, 1993

Sep 05, 2007

2440MG/10ML (244MG/ML)

3660MG/15ML (244MG/ML)

N021711 001
N021711 002

Dec 22, 2008

Dec 22, 2008

469.01MG/ML
469.01MG/ML

N019596 001
N021037 001

Jun 02, 1988

Mar 10, 2000

GABAPENTIN ENACARBIL
TABLET, EXTENDED RELEASE; ORAL

HORIZANT

XX
GLAXO GRP LTD
300MG

XX +
600MG

GADOBENATE DIMEGLUMINE

XX
XX
XX
XX
XX
XX

INJECTABLE; INTRAVENOUS

MULTIHANCE

+ BRACCO
+
+
+
MULTIHANCE MULTIPACK
+ BRACCO
+

001
002
003
004

23,
23,
23,
23,

2004
2004
2004
2004

GADOBUTROL

XX
XX
XX
XX
XX

SOLUTION; INTRAVENOUS

GADAVIST

+ BAYER HLTHCARE
+
+
+
+

001
002
003
004
005

14,
14,
14,
14,
14,

2011
2011
2011
2011
2011

GADODIAMIDE
INJECTABLE; INJECTION

OMNISCAN

XX + GE HEALTHCARE
XX +

GADOFOSVESET TRISODIUM
SOLUTION; INTRAVENOUS

ABLAVAR

LANTHEUS MEDCL
XX
XX +

GADOPENTETATE DIMEGLUMINE
INJECTABLE; INJECTION

MAGNEVIST

XX + BAYER HLTHCARE
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 199 (of 424)

GADOTERIDOL
INJECTABLE; INJECTION

PROHANCE

XX + BRACCO
PROHANCE MULTIPACK
XX + BRACCO

279.3MG/ML

N020131 001

Nov 16, 1992

279.3MG/ML

N021489 001

Oct 09, 2003

N020937
N020937
N020937
N020937
N020975

001
002
003
004
001

Dec
Dec
Dec
Dec
Dec

08,
08,
08,
08,
08,

1999
1999
1999
1999
1999

N020976
N020976
N020976
N020976

002
003
004
001

Dec
Dec
Dec
Dec

08,
08,
08,
08,

1999
1999
1999
1999

GADOVERSETAMIDE

XX
XX
XX
XX
XX
XX
XX
XX
XX

INJECTABLE; INJECTION

OPTIMARK

+ MALLINCKRODT
1654.5MG/5ML (330.9MG/ML)
+
3309MG/10ML (330.9MG/ML)
+
4963.5MG/15ML (330.9MG/ML)
+
6618MG/20ML (330.9MG/ML)
+
16.545GM/50ML (330.9MG/ML)
OPTIMARK IN PLASTIC CONTAINER
+ MALLINCKRODT
3309MG/10ML (330.9MG/ML)
+
4963.5MG/15ML (330.9MG/ML)
+
6618MG/20ML (330.9MG/ML)
+
9927MG/30ML (330.9MG/ML)

GADOXETATE DISODIUM
SOLUTION; INTRAVENOUS

EOVIST

XX + BAYER HLTHCARE

1.8143GM/10ML (181.43MG/ML)

N022090 001

Jul 03, 2008

A078189
A078189
A078189
A078484
A078484
A078484
A090900
A090900
A090900
A090178
A090178
A090178
A079028
A079028
A079028

Sep
Sep
Sep
May
May
May
Jan
Jan
Jan
Feb
Feb
Feb
Dec
Dec
Dec

GALANTAMINE HYDROBROMIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

CAPSULE, EXTENDED RELEASE; ORAL

GALANTAMINE HYDROBROMIDE
BARR
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE
IMPAX LABS
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE
MYLAN
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE
SUN PHARMA GLOBAL
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE
WATSON LABS
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE
RAZADYNE ER
+ JANSSEN PHARMS
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE

SOLUTION; ORAL
GALANTAMINE HYDROBROMIDE
ROXANE
AA
4MG/ML
RAZADYNE
AA + JANSSEN PHARMS
4MG/ML

AB
AB
AB
AB

TABLET; ORAL
GALANTAMINE HYDROBROMIDE
APOTEX INC
EQ
EQ
EQ
AUROBINDO PHARMA LTD EQ

4MG BASE
8MG BASE
12MG BASE
4MG BASE

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

15,
15,
15,
27,
27,
27,
24,
24,
24,
02,
02,
02,
15,
15,
15,

2008
2008
2008
2009
2009
2009
2011
2011
2011
2011
2011
2011
2008
2008
2008

N021615 001
N021615 002
N021615 003

Apr 01, 2005

Apr 01, 2005
Apr 01, 2005

A078185 001

Jan 30, 2009

N021224 001

Jun 22, 2001

A077781
A077781
A077781
A090957

Sep
Sep
Sep
Mar

001
002
003
001

27,
27,
27,
29,

2011
2011
2011
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 200 (of 424)

GALANTAMINE HYDROBROMIDE
TABLET; ORAL
GALANTAMINE HYDROBROMIDE
AUROBINDO PHARMA LTD EQ
AB
AB
EQ
BARR
AB
EQ
AB
EQ
AB
EQ
DR REDDYS LABS LTD
AB
EQ
AB
EQ
AB
EQ
MYLAN
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
ROXANE
AB
EQ
AB
EQ
AB
EQ
SANDOZ
AB
EQ
AB
EQ
AB
EQ
TEVA PHARMS
AB
EQ
AB
EQ
AB
EQ
ZYDUS PHARMS USA INC EQ
AB
AB
EQ
AB
EQ
RAZADYNE
AB + JANSSEN PHARMS
EQ
AB
EQ
AB
EQ

8MG BASE
12MG BASE
4MG BASE
8MG BASE
12MG BASE
4MG BASE
8MG BASE
12MG BASE
4MG BASE
4MG BASE
8MG BASE
8MG BASE
12MG BASE
12MG BASE
4MG BASE
8MG BASE
12MG BASE
4MG BASE
8MG BASE
12MG BASE
4MG BASE
8MG BASE
12MG BASE
4MG BASE
8MG BASE
12MG BASE

A090957
A090957
A077605
A077605
A077605
A077593
A077593
A077593
A077590
A077603
A077590
A077603
A077590
A077603
A077608
A077608
A077608
A077589
A077589
A077589
A077587
A077587
A077587
A078898
A078898
A078898

002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003
001
002
003
001
002
003

4MG BASE
8MG BASE
12MG BASE

N021169 001
N021169 002
N021169 003

Mar
Mar
Aug
Aug
Aug
Sep
Sep
Sep
May
Aug
May
Aug
May
Aug
Feb
Feb
Feb
Jun
Jun
Jun
Jul
Jul
Jul
Feb
Feb
Feb

29,
29,
28,
28,
28,
11,
11,
11,
29,
28,
29,
28,
29,
28,
11,
11,
11,
22,
22,
22,
09,
09,
09,
17,
17,
17,

2011
2011
2008
2008
2008
2008
2008
2008
2009
2008
2009
2008
2009
2008
2009
2009
2009
2009
2009
2009
2009
2009
2009
2011
2011
2011

Feb 28, 2001

Feb 28, 2001
Feb 28, 2001

GALLIUM CITRATE GA-67

INJECTABLE; INJECTION
GALLIUM CITRATE GA 67
BS
LANTHEUS MEDCL
BS
MALLINCKRODT

2mCi/ML
2mCi/ML

N017478 001
N018058 001

25MG/ML

N019961 002

Jan 17, 1991

CAPSULE; ORAL
GANCICLOVIR
RANBAXY
XX
XX +

250MG
500MG

A076457 001
A076457 002

Jun 27, 2003

Jun 27, 2003

GEL; OPHTHALMIC

ZIRGAN

XX + BAUSCH AND LOMB

0.15%

N022211 001

Sep 15, 2009

IMPLANT; IMPLANTATION

VITRASERT

XX + BAUSCH AND LOMB

4.5MG

N020569 001

Mar 04, 1996

GALLIUM NITRATE
INJECTABLE; INJECTION

GANITE

XX + GENTA

GANCICLOVIR

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 201 (of 424)

GANCICLOVIR SODIUM
INJECTABLE; INJECTION
CYTOVENE
AP + ROCHE PALO
GANCICLOVIR
APP PHARMS
AP

EQ 500MG BASE/VIAL

N019661 001

Jun 23, 1989

EQ 500MG BASE/VIAL

A090658 001

Jun 21, 2010

N021057 001

Jul 29, 1999

A079084 001

Aug 19, 2011

N021493 001

Mar 28, 2003

N022548 001

May 18, 2010

A091594
A091594
A091594
A079160
A079160
A090242
A091365
A091365
A090799
A090799
A090799
A078339
A078339
A079183
A200145
A200145
A200145
A078433
A078433
A077983
A077983
A078759
A078759

Jul
Jul
Jul
Jul
Jul
May
Jul
Jul
Jul
Jul
May
Jul
Jul
Nov
Jul
Jul
Jul
Jul
Jul
Jan
Jan
Jul
Jul

GANIRELIX ACETATE
INJECTABLE; INJECTION

GANIRELIX ACETATE INJECTION

EQ 250MCG BASE/0.5ML
XX + ORGANON USA INC

GATIFLOXACIN
SOLUTION/DROPS; OPHTHALMIC
GATIFLOXACIN
APOTEX CORP
AT
0.3%
ZYMAR
AT + ALLERGAN
0.3%
ZYMAXID
0.5%
XX + ALLERGAN

GEMCITABINE HYDROCHLORIDE

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
XX
XX
XX

INJECTABLE; INJECTION
GEMCITABINE HYDROCHLORIDE
ACCORD HLTHCARE
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
ACTAVIS TOTOWA
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
APP PHARMS
EQ 2GM BASE/VIAL
DR REDDYS LABS LTD
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
FRESENIUS KABI ONCOL EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
HOSPIRA
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
+ HOSPIRA INC
EQ 2GM BASE/VIAL
ONCO THERAPIES LTD
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
SUN PHARMA GLOBAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
TEVA PARENTERAL
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
WATSON LABS
EQ 200MG BASE/VIAL
EQ 1GM BASE/VIAL
GEMZAR
+ LILLY
EQ 200MG BASE/VIAL
+
EQ 1GM BASE/VIAL
GEMCITABINE
+ HOSPIRA INC
200MG/5.26ML (38MG/ML)
+
1GM/26.3ML (38MG/ML)
+
2GM/52.6ML (38MG/ML)

001
002
003
001
002
003
001
002
001
002
003
001
002
001
001
002
003
001
002
002
001
001
002

25,
25,
25,
25,
25,
16,
25,
25,
25,
25,
16,
25,
25,
15,
25,
25,
25,
25,
25,
25,
25,
25,
25,

2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2010
2011
2011
2011
2011
2011
2011
2011
2011
2011

N020509 001
N020509 002

May 15, 1996

May 15, 1996

N200795 001
N200795 002
N200795 003

Aug 04, 2011

Aug 04, 2011
Aug 04, 2011

A075034 001
A078012 001

Jul 20, 1998

Mar 26, 2007

GEMFIBROZIL
TABLET; ORAL
GEMFIBROZIL
APOTEX
AB
BLU CARIBE
AB

600MG
600MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 202 (of 424)

GEMFIBROZIL

AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
GEMFIBROZIL
DAVA PHARMS INC
HIKMA PHARMS
IMPAX PHARMS
INVAGEN PHARMS
NORTHSTAR HLTHCARE
SUN PHARM INDS INC
TEVA
WATSON LABS
LOPID
+ PFIZER PHARMS

001
001
001
001
001
001
001
001

Sep
Aug
Jun
Jul
Sep
Dec
Oct
Apr

27,
16,
01,
27,
13,
29,
31,
28,

1993
2010
2007
2006
2010
2008
1993
1995

600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG

A074270
A078599
A078207
A077836
A079072
A079239
A074256
A074442

600MG

N018422 003

Nov 20, 1986

EQ 320MG BASE

N021158 001

Apr 04, 2003

EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE

A062531 001
A062307 001
A062427 001

Jul 05, 1984

A062356
A062356
A062366
A062420
A062612
A062420

001
002
001
001
004
002

Mar
Mar
Aug
Aug
Feb
Aug

04,
04,
04,
15,
20,
15,

1982
1982
1983
1983
1986
1983

A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062814
A062414
A062414
A062414
A062414
A062414
A062414
A062414
A062414
A062414
A062414

001
002
003
004
005
006
007
008
009
010
011
012
013
014
001
002
003
004
005
006
007
008
009
010

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug

28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
15,
15,
15,
15,
15,
15,
15,
15,
15,
15,

1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1983
1983
1983
1983
1983
1983
1983
1983
1983
1983

GEMIFLOXACIN MESYLATE
TABLET; ORAL

FACTIVE

XX + CORNERSTONE THERAP

GENTAMICIN SULFATE
CREAM; TOPICAL
GENTAMICIN SULFATE
AT + FOUGERA
PERRIGO NEW YORK
AT
TARO
AT

INJECTABLE; INJECTION
GENTAMICIN SULFATE
AP + APP PHARMS
EQ 10MG BASE/ML
AP +
EQ 40MG BASE/ML
AP
EQ 40MG BASE/ML
HOSPIRA
AP
EQ 10MG BASE/ML
AP
EQ 10MG BASE/ML
AP
EQ 40MG BASE/ML
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP + B BRAUN
EQ 0.8MG BASE/ML
AP +
EQ 1.2MG BASE/ML
AP +
EQ 1.4MG BASE/ML
AP +
EQ 1.6MG BASE/ML
AP +
EQ 1.8MG BASE/ML
AP +
EQ 2MG BASE/ML
AP +
EQ 2.4MG BASE/ML
AP +
EQ 40MG BASE/100ML
AP +
EQ 60MG BASE/100ML
AP +
EQ 70MG BASE/100ML
AP +
EQ 80MG BASE/100ML
AP +
EQ 90MG BASE/100ML
AP +
EQ 100MG BASE/100ML
AP +
EQ 120MG BASE/100ML
HOSPIRA
AP
EQ 1.2MG BASE/ML
AP
EQ 1.4MG BASE/ML
AP
EQ 1.6MG BASE/ML
AP
EQ 1.8MG BASE/ML
AP
EQ 2MG BASE/ML
AP
EQ 60MG BASE/100ML
AP
EQ 70MG BASE/100ML
AP
EQ 80MG BASE/100ML
AP
EQ 90MG BASE/100ML
AP
EQ 100MG BASE/100ML
ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
BAXTER HLTHCARE
AP
EQ 0.8MG BASE/ML

A062373 001

May 26, 1983

Sep 07, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 203 (of 424)

GENTAMICIN SULFATE
INJECTABLE; INJECTION
ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
BAXTER HLTHCARE
AP
EQ 1.2MG BASE/ML
AP
EQ 1.6MG BASE/ML
AP
EQ 2MG BASE/ML
AP
EQ 2.4MG BASE/ML
AP
EQ 40MG BASE/100ML
AP
EQ 60MG BASE/100ML
AP
EQ 80MG BASE/100ML
AP
EQ 100MG BASE/100ML
AP
EQ 120MG BASE/100ML

A062373
A062373
A062373
A062373
A062373
A062373
A062373
A062373
A062373

OINTMENT; OPHTHALMIC
GENTAMICIN SULFATE
AT + AKORN
FERA PHARMS
AT

EQ 0.3% BASE
EQ 0.3% BASE

A064093 001
A065024 001

Aug 31, 1995

Jul 30, 2004

OINTMENT; TOPICAL
GENTAMICIN SULFATE
FOUGERA
AT
AT + PERRIGO NEW YORK
TARO
AT

EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE

A062533 001
A062351 001
A062477 001

Oct 05, 1984

Feb 18, 1982
Dec 23, 1983

0.3% BASE

A062452 001

Oct 10, 1984

0.3% BASE

A064163 001

Oct 12, 2001

0.3%
0.3%
0.3%
0.3%

A062635
A064048
A062196
A065121

001
001
001
001

Jan 08, 1987

May 11, 1994

N050612 001

Dec 01, 1989

N050586 001

Jun 10, 1988

20MG/ML

N020622 002

Feb 12, 2002

1MG
2MG
4MG

N020496 001
N020496 002
N020496 003

Nov 30, 1995

Nov 30, 1995
Nov 30, 1995

1MG
2MG
4MG
1MG
2MG
4MG
1MG

A078181
A078181
A078181
A077911
A077911
A077911
A077274

Aug
Aug
Aug
Sep
Sep
Sep
Oct

AT
AT
AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
GENOPTIC
ALLERGAN
EQ
GENTAK
AKORN
EQ
GENTAMICIN SULFATE
AKORN
EQ
+ BAUSCH AND LOMB
EQ
FALCON PHARMS
EQ
FERA PHARMS
EQ

BASE
BASE
BASE
BASE

007
008
009
010
003
004
002
005
006

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

07,
07,
07,
07,
07,
07,
07,
07,
07,

1982
1982
1982
1982
1982
1982
1982
1982
1982

Jan 30, 2004

GENTAMICIN SULFATE; PREDNISOLONE ACETATE

OINTMENT; OPHTHALMIC

PRED-G

XX + ALLERGAN

EQ 0.3% BASE;0.6%

SUSPENSION/DROPS; OPHTHALMIC

PRED-G

XX + ALLERGAN
EQ 0.3% BASE;1%

GLATIRAMER ACETATE
INJECTABLE; SUBCUTANEOUS

COPAXONE

XX + TEVA

GLIMEPIRIDE
TABLET; ORAL
AMARYL
AB + SANOFI AVENTIS US
AB
AB
GLIMEPIRIDE
ACCORD HLTHCARE
AB
AB
AB
CARLSBAD
AB
AB
AB
COREPHARMA
AB

001
002
003
001
002
003
001

23,
23,
23,
22,
22,
22,
06,

2007
2007
2007
2009
2009
2009
2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 204 (of 424)

GLIMEPIRIDE
TABLET; ORAL
GLIMEPIRIDE
COREPHARMA
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
RANBAXY
AB
AB
AB
AB
TEVA
AB
AB
AB
VINTAGE
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
WATSON LABS FLORIDA
AB
AB
AB

2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
1MG
2MG
2MG
4MG
4MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
1MG
2MG
4MG

A077274
A077274
A077091
A077091
A077091
A077295
A077295
A077295
A077486
A077624
A077486
A077624
A077486
A077624
A076875
A076875
A076875
A076875
A076802
A076802
A076802
A077370
A077370
A077370
A077370
A077280
A077280
A077280
A076995
A076995
A076995

002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
004
001
002
003
001
002
003
004
001
002
003
001
002
003

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Feb
Nov
Feb
Nov
Feb
Nov
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Dec
Dec
Dec
Dec
Feb
Feb
Feb
Apr
Apr
Apr

06,
06,
06,
06,
06,
06,
06,
06,
10,
28,
10,
28,
10,
28,
06,
06,
06,
06,
06,
06,
06,
23,
23,
23,
23,
03,
03,
03,
27,
27,
27,

2005
2005
2005
2005
2005
2005
2005
2005
2006
2005
2006
2005
2006
2005
2005
2005
2005
2005
2005
2005
2005
2005
2005
2005
2005
2006
2006
2006
2010
2010
2010

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

TABLET; ORAL

DUETACT

XX + TAKEDA GLOBAL
XX

2MG;30MG
4MG;30MG

N021925 001
N021925 002

Jul 28, 2006

Jul 28, 2006

1MG;4MG
2MG;4MG
2MG;8MG
4MG;4MG
4MG;8MG

N021700
N021700
N021700
N021700
N021700

001
002
004
003
005

Nov
Nov
Mar
Nov
Mar

23,
23,
30,
23,
30,

2005
2005
2007
2005
2007

5MG
10MG
5MG
10MG
5MG
10MG
5MG

A074550
A074550
A075795
A075795
A077820
A077820
A074497

001
002
001
002
001
002
001

Sep
Sep
Jun
Jun
Jul
Jul
Aug

11,
11,
13,
13,
11,
11,
31,

1997
1997
2001
2001
2006
2006
1995

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

TABLET; ORAL

AVANDARYL

XX + SB PHARMCO
XX
XX
XX
XX

GLIPIZIDE
TABLET; ORAL
GLIPIZIDE
ACCORD HLTHCARE INC
AB
AB
APOTEX
AB
AB
CARACO
AB
AB
IVAX SUB TEVA PHARMS
AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 205 (of 424)

GLIPIZIDE
TABLET; ORAL
GLIPIZIDE
IVAX SUB TEVA PHARMS
AB
MYLAN
AB
AB
AB
AB
SANDOZ
AB
AB
WATSON LABS
AB
AB
AB
AB
GLUCOTROL
PFIZER
AB
AB +

31,
10,
20,
10,
20,
07,
07,
27,
22,
27,
22,

1995
1994
1995
1994
1995
1995
1995
1995
1994
1995
1994

A074497
A074226
A074438
A074226
A074438
A074305
A074305
A074223
A074370
A074223
A074370

5MG
10MG

N017783 001
N017783 002

May 08, 1984

May 08, 1984

A076467 003
A076467 001
A076467 002

Mar 27, 2006

Sep 08, 2003
Nov 07, 2003

N020329 003
N020329 001
N020329 002

Aug 10, 1999

Apr 26, 1994
Apr 26, 1994

A077620
A077620
A077620
A077507
A077507
A077507
A078728
A078728
A078728
A078083
A078083
A078083
A077270
A077270
A077270
A078905
A078905
A078905

Jan
Jan
Jan
Oct
Oct
Oct
Jun
Jun
Jun
Apr
Apr
Apr
Oct
Oct
Oct
Jan
Jan
Jan

TABLET, EXTENDED RELEASE; ORAL

GLIPIZIDE
WATSON LABS
AB
2.5MG
AB
5MG
AB
10MG
GLUCOTROL XL
PFIZER
AB
2.5MG
AB
5MG
AB +
10MG

002
001
001
002
002
001
002
001
001
002
002

Aug
May
Jun
May
Jun
Apr
Apr
Feb
Nov
Feb
Nov

10MG
5MG
5MG
10MG
10MG
5MG
10MG
5MG
5MG
10MG
10MG

GLIPIZIDE; METFORMIN HYDROCHLORIDE

TABLET; ORAL
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
CARACO
AB
2.5MG;250MG
AB
2.5MG;500MG
AB
5MG;500MG
COREPHARMA
AB
2.5MG;250MG
AB
2.5MG;500MG
AB
5MG;500MG
HERITAGE PHARMS INC
AB
2.5MG;250MG
AB
2.5MG;500MG
AB
5MG;500MG
MYLAN
AB
2.5MG;250MG
AB
2.5MG;500MG
AB
5MG;500MG
TEVA PHARMS
AB
2.5MG;250MG
AB
2.5MG;500MG
AB +
5MG;500MG
ZYDUS PHARMS USA INC 2.5MG;250MG
AB
AB
2.5MG;500MG
AB
5MG;500MG

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

11,
11,
11,
27,
27,
27,
23,
23,
23,
12,
12,
12,
28,
28,
28,
31,
31,
31,

2008
2008
2008
2005
2005
2005
2010
2010
2010
2007
2007
2007
2005
2005
2005
2011
2011
2011

GLUCAGON HYDROCHLORIDE RECOMBINANT

INJECTABLE; INJECTION

GLUCAGEN

XX + NOVO NORDISK

EQ 1MG BASE/VIAL

N020918 001

Jun 22, 1998

1MG/VIAL

N020928 001

Sep 11, 1998

GLUCAGON RECOMBINANT
INJECTABLE; INJECTION

GLUCAGON

XX + LILLY

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 206 (of 424)

GLUTAMINE
FOR SOLUTION; ORAL

NUTRESTORE

XX + EMMAUS MEDCL

5GM/PACKET

N021667 001

Jun 10, 2004

1.25MG
2.5MG
5MG
1.25MG
2.5MG
5MG
1.25MG
2.5MG
5MG
1.25MG
2.5MG
5MG

A077537
A077537
A077537
A076257
A076257
A076257
A090937
A090937
A090937
A074388
A074388
A074388

001
002
003
001
002
003
001
002
003
001
002
003

Oct
Oct
Oct
Jun
Jun
Jun
Feb
Feb
Feb
Aug
Aug
Aug

18,
18,
18,
27,
27,
27,
28,
28,
28,
29,
29,
29,

2007
2007
2007
2002
2002
2002
2011
2011
2011
1995
1995
1995

1.5MG
3MG
4.5MG
6MG
1.5MG
3MG
6MG
1.5MG
3MG
6MG
1.5MG
3MG
4.5MG
6MG

A074591
A074591
A074591
A074591
A075890
A075890
A075890
A074792
A074792
A074792
A074686
A074686
A074686
A074686

001
002
003
004
001
002
003
001
002
003
001
002
003
004

Dec
Dec
Dec
Dec
Jul
Jul
Jul
Jun
Jun
Aug
Apr
Apr
Apr
Apr

22,
22,
22,
22,
31,
31,
31,
26,
26,
17,
20,
20,
20,
20,

1997
1997
1997
1997
2003
2003
2003
1998
1998
1999
1999
1999
1999
1999

1.5MG
3MG
6MG

N020051 001
N020051 002
N020051 004

Mar 04, 1992

Mar 04, 1992
Sep 24, 1993

1.25MG
2.5MG
5MG

N017532 001
N017532 002
N017532 003

May 01, 1984

May 01, 1984
May 01, 1984

N021178 001
N021178 002
N021178 003

Jul 31, 2000

Jul 31, 2000
Jul 31, 2000

A076716
A076716
A076716
A077870
A077870
A077870
A076731
A076731
A076731

Jun
Jun
Jun
Nov
Nov
Nov
Nov
Nov
Nov

GLYBURIDE
TABLET; ORAL
GLYBURIDE
AUROBINDO PHARMA
AB
AB
AB
COREPHARMA
AB
AB
AB
HERITAGE PHARMS INC
AB
AB
AB
TEVA
AB
AB
AB +
GLYBURIDE (MICRONIZED)
DAVA PHARMS INC
AB
AB
AB
AB
HIKMA
AB
AB
AB
MYLAN
AB
AB
AB
TEVA
AB
AB
AB
AB
GLYNASE
PHARMACIA AND UPJOHN
AB
AB
AB +
DIABETA
BX
SANOFI AVENTIS US
BX
BX +

GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET; ORAL
GLUCOVANCE
BRISTOL MYERS SQUIBB
AB
AB +
AB
GLYBURIDE AND METFORMIN
ACTAVIS ELIZABETH
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
COREPHARMA
AB
AB
AB

1.25MG;250MG
2.5MG;500MG
5MG;500MG
HYDROCHLORIDE
1.25MG;250MG
2.5MG;500MG
5MG;500MG
1.25MG;250MG
2.5MG;500MG
5MG;500MG
1.25MG;250MG
2.5MG;500MG
5MG;500MG

001
002
003
001
002
003
001
002
003

28,
28,
28,
14,
14,
14,
19,
19,
19,

2005
2005
2005
2007
2007
2007
2004
2004
2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 207 (of 424)

GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET; ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDE
DR REDDYS LABS INC
AB
1.25MG;250MG
AB
2.5MG;500MG
AB
5MG;500MG
IVAX SUB TEVA PHARMS 1.25MG;250MG
AB
AB
2.5MG;500MG
AB
5MG;500MG

A079009
A079009
A079009
A076345
A076345
A076345

001
002
003
001
002
003

Jun
Jun
Jun
Feb
Feb
Feb

03,
03,
03,
18,
18,
18,

2009
2009
2009
2004
2004
2004

GLYCINE
SOLUTION; IRRIGATION
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
AT
1.5GM/100ML
GLYCINE 1.5% IN PLASTIC CONTAINER
B BRAUN
AT
1.5GM/100ML
HOSPIRA
AT
1.5GM/100ML

N017865 001
N016784 001
N018315 001

GLYCOPYRROLATE
INJECTABLE; INJECTION
GLYCOPYRROLATE
HIKMA FARMACEUTICA
AP
LUITPOLD
AP
ROBINUL
AP + BAXTER HLTHCARE
SOLUTION; ORAL

CUVPOSA

XX + SHIONOGI INC
TABLET; ORAL
GLYCOPYRROLATE
BOCA PHARMA
AA
AA
COREPHARMA
AA
AA
DR REDDYS LABS LTD
AA
AA
PAR PHARM
AA
AA
RANBAXY
AA
AA
VINTAGE
AA
AA
WEST WARD
AA
AA
ROBINUL
AA + SHIONOGI INC
ROBINUL FORTE
AA + SHIONOGI INC

A090963 001
A089335 001

0.2MG/ML

N017558 001

1MG/5ML

N022571 001

Jul 28, 2010

1MG
2MG
1MG
2MG
1MG
2MG
1MG
2MG
1MG
2MG
1MG
2MG
1MG
2MG

A090020
A090020
A040568
A040568
A040847
A040847
A040653
A040653
A040844
A040844
A040821
A040821
A040836
A040836

Oct
Oct
Dec
Dec
Mar
Mar
Aug
Aug
Aug
Aug
Dec
Dec
Mar
Mar

1MG

N012827 001

2MG

N012827 002

10,000 UNITS/VIAL
10,000 UNITS/VIAL

N017067 002
N017016 007

10,000 UNITS/VIAL

N017692 001

001
002
001
002
001
002
001
002
001
002
001
002
001
002

GONADOTROPIN, CHORIONIC
INJECTABLE; INJECTION
CHORIONIC GONADOTROPIN
AP + APP PHARMS
AP + FERRING
PREGNYL
AP + ORGANON USA INC

Sep 21, 2011

Jul 23, 1986

0.2MG/ML
0.2MG/ML

19,
19,
22,
22,
21,
21,
31,
31,
18,
18,
29,
29,
05,
05,

2011
2011
2004
2004
2008
2008
2006
2006
2009
2009
2008
2008
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 208 (of 424)

GOSERELIN ACETATE
IMPLANT; IMPLANTATION

ZOLADEX

XX + ASTRAZENECA
XX +

EQ 3.6MG BASE
EQ 10.8MG BASE

N019726 001
N020578 001

Dec 29, 1989

Jan 11, 1996

GRAMICIDIN
1.75MG BASE/ML;10,000

A064047 001

Jan 31, 1996

1.75MG BASE/ML;10,000

A065187 001

Oct 28, 2005

1.75MG BASE/ML;10,000

A060582 001

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS; OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND
AT + BAUSCH AND LOMB
0.025MG/ML;EQ
UNITS/ML
LUITPOLD
AT
0.025MG/ML;EQ
UNITS/ML
NEOSPORIN
AT + MONARCH PHARMS
0.025MG/ML;EQ
UNITS/ML

GRANISETRON
FILM, EXTENDED RELEASE; TRANSDERMAL

SANCUSO

XX + PROSTRAKAN INC
3.1MG/24HR

N022198 001

Sep 12, 2008

A079119
A079078
A079078
A078522
A078090
A077177
A077913
A077186
A077187
A078197
A078198
A078198
A078863
A078880
A078808
A078835
A078835
A091274
A091136
A091136
A091137
A078534
A078531
A078531
A078392
A077963
A077297
A078262
A078258
A078258
A078566
A078564
A078565

Sep
Sep
Sep
Dec
Jun
Dec
Jun
Jun
Jun
Dec
Jun
Jun
Jun
Jun
Apr
Jun
Jun
Sep
Apr
Apr
Apr
Apr
Apr
Apr
Dec
Jan
Jun
Dec
Jun
Jun
Feb
Jun
Jun

GRANISETRON HYDROCHLORIDE

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
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
GRANISETRON HYDROCHLORIDE
AKORN INC
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)
APP PHARMS
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
BAXTER HLTHCARE
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
BEDFORD LABS
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)
CLARIS LIFESCIENCES
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)
DR REDDYS LABS INC
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EBEWE PHARMA
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)
LUITPOLD
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
SAGENT STRIDES
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)
SANDOZ
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)
+ TEVA PARENTERAL
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)
WATSON LABS
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)
WOCKHARDT USA
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)
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
APP PHARMS
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

001
002
001
001
001
001
001
001
001
001
001
002
001
001
001
001
002
001
001
002
002
001
001
002
001
001
001
001
001
002
001
001
001

A078096 001

10,
14,
14,
31,
30,
31,
26,
30,
30,
31,
30,
30,
30,
30,
29,
30,
30,
22,
09,
09,
09,
30,
30,
30,
31,
03,
30,
31,
30,
30,
29,
30,
30,

2009
2009
2009
2007
2008
2007
2008
2008
2008
2007
2008
2008
2008
2008
2008
2008
2008
2010
2010
2010
2010
2009
2009
2009
2007
2008
2008
2007
2008
2008
2008
2008
2008

Jun 30, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 209 (of 424)

GRANISETRON HYDROCHLORIDE

AP
AP
AP
AP

INJECTABLE; INJECTION
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
DR REDDYS LABS INC
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
+ TEVA PARENTERAL
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
GRANISTERON HYDROCHLORIDE
HIKMA FARMACEUTICA
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

SOLUTION; ORAL

GRANISETRON HYDROCHLORIDE

EQ 2MG BASE/10ML
XX + PEDIATRX

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
GRANISETRON HYDROCHLORIDE
APOTEX INC
EQ
CIPLA LTD
EQ
COREPHARMA
EQ
DR REDDYS LABS LTD
EQ
MYLAN
EQ
NATCO PHARMA
EQ
ORCHID HLTHCARE
EQ
ROXANE
EQ
TARO
EQ
EQ
+ TEVA PHARMS

1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A078863 002
A077165 001

Jun 30, 2008

Dec 31, 2007

A078629 001
A078629 002

Dec 23, 2009

Dec 23, 2009

A078334 001

Feb 28, 2008

A078843
A078037
A078260
A078846
A078725
A078969
A078678
A077842
A090817
A078080

Feb
Feb
Dec
Feb
Jan
Jun
Feb
Dec
May
Dec

001
001
001
001
001
001
001
001
001
001

27,
27,
31,
27,
30,
22,
13,
31,
28,
31,

2008
2008
2007
2009
2008
2009
2008
2007
2010
2007

GRISEOFULVIN
SUSPENSION; ORAL
GRISEOFULVIN
VINTAGE
AB

A065438 001

Oct 08, 2010

125MG/5ML

A062483 001

Jan 26, 1984

125MG/5ML
125MG/5ML
125MG/5ML

A065394 001
A065354 001
A065200 001

Jul 06, 2007

Sep 10, 2007
Mar 02, 2005

500MG

A062279 003

125MG/5ML

GRISEOFULVIN, MICROCRYSTALLINE

AB
AB
AB
AB

SUSPENSION; ORAL
GRIFULVIN V
+ ORTHONEUTROGENA
GRISEOFULVIN
ACTAVIS MID ATLANTIC
IVAX SUB TEVA PHARMS
PERRIGO CO TENNESSEE

TABLET; ORAL

GRIFULVIN V

XX + ORTHONEUTROGENA

GRISEOFULVIN, ULTRAMICROCRYSTALLINE
TABLET; ORAL

GRIS-PEG

PEDINOL

XX
XX +

125MG
250MG

N050475 001

N050475 002

EQ 4MG BASE
EQ 8MG BASE

A074149 001

A074149 002

Apr 07, 1995

Apr 07, 1995

A075109 001
A075109 002
A074673 001

Nov 25, 1998

Nov 25, 1998
Feb 28, 1997

GUANABENZ ACETATE
TABLET; ORAL
GUANABENZ ACETATE
IVAX SUB TEVA PHARMS
XX
XX +

GUANFACINE HYDROCHLORIDE
TABLET; ORAL
GUANFACINE HYDROCHLORIDE
AMNEAL PHARM
AB
EQ 1MG BASE
AB
EQ 2MG BASE
EPIC PHARMA
AB
EQ 1MG BASE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 210 (of 424)

GUANFACINE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
GUANFACINE HYDROCHLORIDE
EPIC PHARMA
EQ
MYLAN
EQ
EQ
WATSON LABS
EQ
EQ
TENEX
PROMIUS PHARMA
EQ
+
EQ

2MG
1MG
2MG
1MG
2MG

BASE
BASE
BASE
BASE
BASE

1MG BASE
2MG BASE

TABLET, EXTENDED RELEASE; ORAL

INTUNIV
SHIRE
EQ 1MG
XX
EQ 2MG
XX
EQ 3MG
XX
EQ 4MG
XX +

BASE
BASE
BASE
BASE

A074673
A074796
A074796
A074145
A074145

002
001
002
001
002

Feb
Jan
Jan
Oct
Oct

28,
27,
27,
17,
17,

1997
1997
1997
1995
1995

N019032 001
N019032 002

Oct 27, 1986

Nov 07, 1988

N022037
N022037
N022037
N022037

Sep
Sep
Sep
Sep

02,
02,
02,
02,

2009
2009
2009
2009

Dec
Apr
Dec
Aug

16,
24,
16,
04,

2004
2007
2004
2005

001
002
003
004

GUANIDINE HYDROCHLORIDE
TABLET; ORAL

GUANIDINE HYDROCHLORIDE

SCHERING
125MG
XX

N001546 001

HALCINONIDE
CREAM; TOPICAL

HALOG

XX + RANBAXY

0.1%

N017556 001

OINTMENT; TOPICAL

HALOG

XX + RANBAXY

0.1%

N017824 001

0.05%
0.05%
0.05%
0.05%

A077001
A078162
A077123
A077227

0.05%

N019967 001

Dec 27, 1990

0.05%
0.05%
0.05%
0.05%

A076903
A077721
A076872
A076994

Dec
Sep
Dec
Dec

0.05%

N019968 001

Dec 17, 1990

0.5MG
1MG
2MG
5MG
10MG
20MG
0.5MG

A070278
A070278
A070278
A070278
A070278
A070278
A071206

Jun
Jun
Jun
Jun
Jul
Jul
Nov

HALOBETASOL PROPIONATE

AB
AB
AB
AB
AB

AB
AB
AB
AB
AB

CREAM; TOPICAL
HALOBETASOL PROPIONATE
ALTANA
G AND W LABS
PERRIGO ISRAEL
TARO
ULTRAVATE
+ RANBAXY
OINTMENT; TOPICAL
HALOBETASOL PROPIONATE
ALTANA
G AND W LABS
PERRIGO
TARO
ULTRAVATE
+ RANBAXY

001
001
001
001

001
001
001
001

16,
07,
16,
16,

2004
2006
2004
2004

HALOPERIDOL
TABLET; ORAL
HALOPERIDOL
MYLAN
AB
AB
AB
AB
AB
AB
SANDOZ
AB

006
004
001
005
002
003
001

10,
10,
10,
10,
16,
16,
17,

1986
1986
1986
1986
2009
2009
1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 211 (of 424)

HALOPERIDOL
TABLET; ORAL
HALOPERIDOL
SANDOZ
AB
AB +
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB

001
001
001
001
001
003
004
005

Nov
Nov
Nov
Mar
Mar
Nov
Nov
Nov

17,
17,
17,
11,
11,
29,
29,
29,

1986
1986
1986
1988
1988
2007
2007
2007

1MG
2MG
5MG
10MG
20MG
5MG
10MG
20MG

A071207
A071208
A071209
A071210
A071211
A077580
A077580
A077580

EQ 50MG BASE/ML
EQ 100MG BASE/ML

N018701 001
N018701 002

Jan 14, 1986

Jan 31, 1997

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A074893
A074893
A074811
A075305
A075440
A075440
A075393
A075393

Dec
Dec
Jan
Sep
Feb
Feb
May
May

HALOPERIDOL DECANOATE
INJECTABLE; INJECTION
HALDOL
AO + JANSSEN PHARMS
AO +
HALOPERIDOL DECANOATE
APP PHARMS
AO
AO
BEDFORD
AO
AO
CLARIS LIFESCIENCES
AO
AO
TEVA PARENTERAL
AO
AO

50MG BASE/ML
100MG BASE/ML
50MG BASE/ML
100MG BASE/ML
50MG BASE/ML
100MG BASE/ML
50MG BASE/ML
100MG BASE/ML

001
002
001
001
001
002
001
002

19,
19,
30,
28,
28,
28,
11,
11,

1997
1997
1998
1998
2000
2000
1999
1999

HALOPERIDOL LACTATE
CONCENTRATE; ORAL
HALOPERIDOL
PHARM ASSOC
AA
SILARX
AA
AA + TEVA PHARMS

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
HALDOL
+ JANSSEN PHARMS
HALOPERIDOL
APP PHARMS
BEDFORD
CLARIS LIFESCIENCES
GLAND PHARMA LTD
PFIZER
SAGENT PHARMS
TEVA PARENTERAL

Feb 26, 1993

Sep 28, 1993
Dec 01, 1988

EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML

A073037 001
A073364 001
A071617 001

EQ 5MG BASE/ML

N015923 001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A075689
A075858
A076791
A076828
A076774
A078347
A091637
A200742
A076035

001
001
001
001
001
001
001
001
001

Mar
Jun
Aug
Aug
Aug
Sep
Sep
Sep
Aug

N017029
N017651
N017029
N017029
N017037
N017037
N017037
A088100
A090571
A090571

001
006
003
004
001
002
003
001
001
002

Apr 28, 1983

Aug 31, 2009
Aug 31, 2009

5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

09,
18,
25,
25,
25,
14,
02,
02,
29,

2001
2001
2004
2004
2004
2009
2011
2011
2001

HEPARIN SODIUM

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
HEPARIN SODIUM
+ APP PHARMS
+
+
+
+ BAXTER HLTHCARE
+
+
HOSPIRA
HOSPIRA INC

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
5,000 UNITS/ML
1,000 UNITS/ML
5,000 UNITS/ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 212 (of 424)

HEPARIN SODIUM
INJECTABLE; INJECTION
HEPARIN SODIUM
HOSPIRA INC
AP
10,000 UNITS/ML
A090571
SAGENT PHARMS
AP
1,000 UNITS/ML
A090808
AP
5,000 UNITS/ML
A090808
AP
10,000 UNITS/ML
A090808
AP
20,000 UNITS/ML
A090809
SANDOZ
AP
1,000 UNITS/ML
A091682
AP
5,000 UNITS/ML
A091659
AP
5,000 UNITS/ML
A091682
AP
10,000 UNITS/ML
A201002
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE
AP
200 UNITS/100ML
N018609
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
AP
200 UNITS/100ML
N019953
HOSPIRA
AP
200 UNITS/100ML
N018916
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA
AP
10,000 UNITS/100ML
N019339
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE
AP
200 UNITS/100ML
N018609
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA
AP
200 UNITS/100ML
N018916
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
AP
4,000 UNITS/100ML
N018814
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
AP
4,000 UNITS/100ML
N019952
HOSPIRA
AP
4,000 UNITS/100ML
N019805
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
AP
5,000 UNITS/100ML
N018814
AP
10,000 UNITS/100ML
N018814
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
AP
5,000 UNITS/100ML
N019952
AP
10,000 UNITS/100ML
N019952
HOSPIRA
AP
5,000 UNITS/100ML
N019339
AP
5,000 UNITS/100ML
N019805
AP
10,000 UNITS/100ML
N019339
HEPARIN SODIUM IN PLASTIC CONTAINER
AP + APP PHARMS
1,000 UNITS/ML
N017029
AP +
5,000 UNITS/ML
N017029
AP +
10,000 UNITS/ML
N017029
AP +
20,000 UNITS/ML
N017029
HEPARIN SODIUM PRESERVATIVE FREE
AP + APP PHARMS
1,000 UNITS/ML
N017029
AP + HOSPIRA
10,000 UNITS/ML
A089522
SAGENT PHARMS
AP
1,000 UNITS/ML
A090810
HEPARIN SODIUM
PFIZER
1,000 UNITS/ML
N201370
XX
5,000 UNITS/ML
N201370
XX
10,000 UNITS/ML
N201370
XX
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA
5,000 UNITS/100ML
N019339
XX
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA
5,000 UNITS/100ML
N018916
XX
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA
5,000 UNITS/100ML
N018916
XX
10,000 UNITS/100ML
N018916
XX
HEPARIN SODIUM PRESERVATIVE FREE
PFIZER
1,000 UNITS/ML
N201370
XX

003
001
002
003
001
001
001
002
001

Aug
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

31,
30,
30,
30,
30,
08,
08,
08,
08,

2009
2010
2010
2010
2010
2011
2011
2011
2011

001

Apr 28, 1982

001
010

Jul 20, 1992

Jun 23, 1989

003

Mar 27, 1985

002

Apr 28, 1982

011

Jun 23, 1989

001

Oct 31, 1983

001
001

Jul 20, 1992

Jan 25, 1989

003
004

Jul 09, 1985

Jul 02, 1987

004
005
004
002
002

Jul
Jul
Mar
Jan
Mar

20,
20,
27,
25,
27,

1992
1992
1985
1989
1985

013
014
015
016

Dec
Dec
Dec
Dec

05,
05,
05,
05,

1985
1985
1985
1985

010
001
001

Apr 28, 1986

May 04, 1987
Jun 30, 2010

001
002
003

Jul 21, 2011

Jul 21, 2011
Jul 21, 2011

001

Mar 27, 1985

006

Jan 31, 1984

007
008

Jan 31, 1984

Jan 31, 1984

004

Jul 21, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 213 (of 424)

HEXACHLOROPHENE
EMULSION; TOPICAL

PHISOHEX

XX + SANOFI AVENTIS US
SPONGE; TOPICAL
PRE-OP
AT + DAVIS AND GECK
PRE-OP II
DAVIS AND GECK
AT

3%

N006882 001

480MG

N017433 001

480MG

N017433 002

HEXAMINOLEVULINATE HYDROCHLORIDE
FOR SOLUTION; INTRAVESICAL

CYSVIEW KIT

100MG/VIAL
XX + GE HEALTHCARE

N022555 001

May 28, 2010

50MG

N022058 001

May 03, 2007

50MG

N021732 001

Oct 12, 2004

A088017 001
A040613 001
A088008 001

Jul 05, 1983

Feb 08, 2008
Mar 03, 1983

A091528 001

Apr 20, 2011

A088508 001

Jul 30, 1985

150 UNITS/ML

N021665 001

Oct 26, 2004

150 UNITS/ML

N021716 001

Oct 25, 2005

200 UNITS/VIAL

N021640 002

Dec 02, 2004

N021859 001

Dec 02, 2005

INJECTABLE; INJECTION
HYDRALAZINE HYDROCHLORIDE
AKORN
AP
20MG/ML
APP PHARMS
AP
20MG/ML
AP + LUITPOLD
20MG/ML

A040730 001
A040388 001
A040136 001

Apr 21, 2009

Mar 13, 2001
Jun 30, 1997

TABLET; ORAL
HYDRALAZINE HYDROCHLORIDE
GLENMARK PHARMS LTD
AA
10MG
AA
25MG
AA
50MG

A090527 001
A090527 002
A090527 003

May 27, 2009

May 27, 2009
May 27, 2009

HISTRELIN ACETATE
IMPLANT; SUBCUTANEOUS

SUPPRELIN LA

XX + ENDO PHARM
VANTAS
XX + ENDO PHARM

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

SYRUP; ORAL
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
ACTAVIS MID ATLANTIC 1.5MG/5ML;5MG/5ML
AA
AA + HI TECH PHARMA
1.5MG/5ML;5MG/5ML
WOCKHARDT
AA
1.5MG/5ML;5MG/5ML
TABLET; ORAL
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
NOVEL LABS INC
AB
1.5MG;5MG
TUSSIGON
AB + KING PHARMS
1.5MG;5MG

HYALURONIDASE
INJECTABLE; INJECTION

AMPHADASE

XX + AMPHASTAR PHARM
HYDASE
XX + AKORN INC
VITRASE
XX + ISTA PHARMS

HYALURONIDASE RECOMBINANT HUMAN

INJECTABLE; INJECTION

HYLENEX RECOMBINANT

XX + HALOZYME THERAP

150 UNITS/ML

HYDRALAZINE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 214 (of 424)

HYDRALAZINE HYDROCHLORIDE

AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA

TABLET; ORAL
HYDRALAZINE HYDROCHLORIDE
GLENMARK PHARMS LTD
100MG
HERITAGE PHARMS INC
10MG
25MG
50MG
100MG
HETERO LABS UNIT III 10MG
25MG
50MG
100MG
INVAGEN PHARMS
10MG
25MG
50MG
100MG
MYLAN
10MG
25MG
50MG
100MG
PAR PHARM
10MG
25MG
50MG
100MG
+ PLIVA
10MG
+
25MG
+
50MG
+
100MG
WATSON LABS
25MG
50MG
ZYDUS PHARMS USA
10MG
25MG
50MG
100MG

A090527
A086242
A086242
A086242
A086242
A040901
A040901
A040901
A040901
A090255
A090255
A090255
A090255
A090413
A090413
A090413
A090413
A087836
A086961
A086962
A088391
A089097
A088467
A088468
A089098
A084504
A084503
A040858
A040858
A040858
A040858

004
001
003
002
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
001
001
001
001
001
001
001
001
001
002
003
004

May 27, 2009

Feb 04, 2010

Feb
Sep
Sep
Sep
Sep
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Oct

04,
12,
12,
12,
12,
15,
15,
15,
15,
08,
08,
08,
08,
05,

2010
2008
2008
2008
2008
2008
2008
2008
2008
2010
2010
2010
2010
1982

Sep
Dec
May
May
Dec

27,
18,
01,
01,
18,

1983
1985
1984
1984
1985

Feb
Feb
Feb
Feb

26,
26,
26,
26,

2010
2010
2010
2010

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

CAPSULE; ORAL
HYDRA-ZIDE
PAR PHARM
XX
XX +

25MG;25MG
50MG;50MG

A088957 001
A088946 001

Oct 21, 1985

Oct 21, 1985

37.5MG;20MG

N020727 001

Jun 23, 2005

12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG

A200645
A078389
A078164
A079237
A077005
A078391
A075640
A090510
A075907
A077885

Nov
May
Sep
Apr
Jul
Feb
Jan
Jan
Sep
Nov

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

TABLET; ORAL

BIDIL

XX + ARBOR PHARMS INC

HYDROCHLOROTHIAZIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
HYDROCHLOROTHIAZIDE
ALEMBIC PHARMS LTD
APOTEX
AUROBINDO PHARMA
IPCA LABS LTD
IVAX SUB TEVA PHARMS
JUBILANT CADISTA
MYLAN
UNICHEM
VINTAGE PHARMS
WEST WARD

001
001
001
001
001
001
001
001
001
001

30,
16,
18,
02,
13,
11,
28,
19,
17,
26,

2010
2008
2007
2009
2005
2008
2000
2010
2002
2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 215 (of 424)

HYDROCHLOROTHIAZIDE
CAPSULE; ORAL
MICROZIDE
AB + WATSON LABS
TABLET; ORAL
HYDROCHLOROTHIAZIDE
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
AB
MYLAN PHARMS INC
AB
AB
UNICHEM
AB
AB
VINTAGE PHARMS
AB
AB
WATSON LABS
AB
WEST WARD
AB
AB
ORETIC
ABBOTT
AB

12.5MG

N020504 001

Dec 27, 1996

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
25MG
25MG
50MG

A040707
A040774
A040774
A040780
A040780
A040857
A040810
A040810
A087059
A087068
A040702
A040702
A085182
A085182
A040807
A040807
A040807
A083177
A083177
A040809
A040809
A084325
A084324
A040770
A040735
A040735
A040907
A040907
A040412
A040412
A081189
A084878
A084878

Feb
Oct
Oct
Jul
Jul
May
Mar
Mar

50MG

N011971 002

001
001
002
001
002
001
001
002
001
001
001
002
002
001
001
002
003
001
002
001
002
001
001
001
002
003
001
002
001
002
001
002
001

27,
03,
03,
20,
20,
30,
27,
27,

2007
2007
2007
2007
2007
2008
2007
2007

Mar 16, 2007

Mar 16, 2007

Jul 20, 2007

Jul 20, 2007
Jul 20, 2007

Sep 04, 2007

Sep 04, 2007

Jan
Jan
Jan
Aug
Aug
Mar
Mar
Jan
Jul

23,
23,
23,
15,
15,
29,
29,
24,
12,

2007
2007
2007
2008
2008
2002
2002
1992
2006

HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET; ORAL

AVALIDE

XX + SANOFI AVENTIS
XX

12.5MG;150MG
12.5MG;300MG

N020758 002
N020758 003

Sep 30, 1997

Aug 31, 1998

A076674
A076674
A076674
A077606
A077606
A077606
A075776
A075776
A075776

Oct
Oct
Oct
Mar
Mar
Mar
Jul
Jul
Jul

HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET; ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
APOTEX INC
AB
12.5MG;10MG
AB
12.5MG;20MG
AB
25MG;20MG
AUROBINDO
AB
12.5MG;10MG
AB
12.5MG;20MG
AB
25MG;20MG
IVAX SUB TEVA PHARMS 12.5MG;10MG
AB
AB
12.5MG;20MG
AB
25MG;20MG

001
002
003
001
002
003
001
002
003

05,
05,
05,
14,
14,
14,
01,
01,
01,

2004
2004
2004
2006
2006
2006
2002
2002
2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 216 (of 424)

HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET; ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
LUPIN
AB
12.5MG;10MG
AB
12.5MG;20MG
AB
25MG;20MG
MYLAN
AB
12.5MG;10MG
AB
12.5MG;20MG
AB
25MG;20MG
PRINSTON INC
AB
12.5MG;10MG
AB
12.5MG;20MG
AB
25MG;20MG
RANBAXY
AB
12.5MG;10MG
AB
12.5MG;20MG
AB
25MG;20MG
SANDOZ
AB
12.5MG;10MG
AB
12.5MG;20MG
AB
25MG;20MG
WATSON LABS
AB
12.5MG;10MG
AB
12.5MG;20MG
AB
25MG;20MG
WEST WARD
AB
12.5MG;10MG
AB
12.5MG;20MG
AB
25MG;20MG
PRINZIDE
MERCK
AB
12.5MG;10MG
AB
12.5MG;20MG
ZESTORETIC
ASTRAZENECA
AB
12.5MG;10MG
AB +
12.5MG;20MG
AB +
25MG;20MG

A077912
A077912
A077912
A076113
A076113
A076113
A076230
A076230
A076230
A076007
A076007
A076007
A076262
A076262
A076262
A076194
A076194
A076194
A076265
A076265
A076265

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
003
001
002
001
002
003

Sep
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

27,
27,
27,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
08,
08,
08,

2006
2006
2006
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002

N019778 003
N019778 001

Nov 18, 1993

Feb 16, 1989

N019888 003
N019888 001
N019888 002

Nov 18, 1993

Sep 20, 1990
Jul 20, 1989

N020387 001
N020387 003
N020387 002

Apr 28, 1995

Oct 20, 2005
Nov 10, 1998

A090150
A090150
A090150
A091629
A091629
A091629
A078245
A078245
A078245
A091652
A091652
A091652
A077732
A077732
A077732
A077948
A077948
A077948
A077157
A077157
A077157

Oct
Aug
Oct
Oct
Oct
Jan
Oct
May
Oct
Oct
Apr
Oct
Oct
Apr
Oct
Oct
Aug
Oct
Apr
Apr
Apr

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

TABLET; ORAL
HYZAAR
MERCK
AB
12.5MG;50MG
AB
12.5MG;100MG
AB +
25MG;100MG
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
APOTEX
AB
12.5MG;50MG
AB
12.5MG;100MG
AB
25MG;100MG
AUROBINDO PHARMA
AB
12.5MG;50MG
AB
12.5MG;100MG
AB
25MG;100MG
LUPIN LTD
AB
12.5MG;50MG
AB
12.5MG;100MG
AB
25MG;100MG
MYLAN
AB
12.5MG;50MG
AB
12.5MG;100MG
AB
25MG;100MG
ROXANE
AB
12.5MG;50MG
AB
12.5MG;100MG
AB
25MG;100MG
SANDOZ
AB
12.5MG;50MG
AB
12.5MG;100MG
AB
25MG;100MG
TEVA PHARMS
AB
12.5MG;50MG
AB
12.5MG;100MG
AB
25MG;100MG

001
002
003
001
002
003
001
002
003
001
002
003
002
001
003
001
003
002
001
002
003

06,
11,
06,
06,
06,
06,
06,
21,
06,
06,
06,
06,
06,
06,
06,
06,
19,
06,
06,
06,
06,

2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 217 (of 424)

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

TABLET; ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
TORRENT PHARMS
AB
12.5MG;50MG
AB
12.5MG;100MG
AB
25MG;100MG
WATSON LABS
AB
12.5MG;50MG
AB
12.5MG;100MG
AB
25MG;100MG
ZYDUS PHARMS USA INC 12.5MG;50MG
AB
AB
25MG;100MG

A090528
A090528
A090528
A200180
A200180
A200180
A078385
A078385

001
003
002
001
002
003
001
002

Oct
Apr
Oct
Jan
Jan
Jan
Oct
Oct

06,
06,
06,
12,
12,
12,
06,
06,

2010
2010
2010
2011
2011
2011
2010
2010

HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET; ORAL
METHYLDOPA AND HYDROCHLOROTHIAZIDE
MYLAN
15MG;250MG
XX
25MG;250MG
XX +

A070264 001
A070265 001

Jan 23, 1986

Jan 23, 1986

N018303 001
N018303 002

Dec 31, 1984

Dec 31, 1984

A076792 001
A076792 002

Aug 20, 2004

Aug 20, 2004

A076792 003

Aug 20, 2004

A090718
A090718
A090718
A090096
A090096
A090096
A076980
A076980
A076980

Mar
Mar
Mar
Sep
Sep
Sep
Mar
Mar
Mar

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

TABLET; ORAL
LOPRESSOR HCT
NOVARTIS
AB
25MG;50MG
AB +
25MG;100MG
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
MYLAN
AB
25MG;50MG
AB
25MG;100MG
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
MYLAN
50MG;100MG
XX

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

TABLET; ORAL
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
GLENMARK PHARMS
AB
12.5MG;7.5MG
AB
12.5MG;15MG
AB
25MG;15MG
PADDOCK LLC
AB
12.5MG;7.5MG
AB
12.5MG;15MG
AB
25MG;15MG
TEVA
AB
12.5MG;7.5MG
AB
12.5MG;15MG
AB
25MG;15MG
UNIRETIC
UCB INC
AB
12.5MG;7.5MG
AB
12.5MG;15MG
AB +
25MG;15MG

001
002
003
001
002
003
001
003
002

17,
17,
17,
25,
25,
25,
07,
07,
07,

2010
2010
2010
2008
2008
2008
2007
2007
2007

N020729 001
N020729 003
N020729 002

Jun 27, 1997

Feb 14, 2002
Jun 27, 1997

N021532 002
N021532 003
N021532 005

Jun 05, 2003

Jun 05, 2003
Jun 05, 2003

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

TABLET; ORAL
BENICAR HCT
XX
DAIICHI SANKYO
XX
XX +

12.5MG;20MG
12.5MG;40MG
25MG;40MG

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

TABLET; ORAL
INDERIDE-40/25
AB + AKRIMAX PHARMS
25MG;40MG
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
MYLAN
AB
25MG;40MG
AB +
25MG;80MG

N018031 001
A070946 001
A070947 001

Mar 04, 1987

Apr 01, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 218 (of 424)

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

TABLET; ORAL
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
PLIVA
AB
25MG;40MG
AB
25MG;80MG
WATSON LABS
AB
25MG;40MG
AB
25MG;80MG

A072042
A072043
A070301
A070305

001
001
001
001

Mar
Mar
Apr
Apr

14,
14,
18,
18,

1988
1988
1986
1986

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

TABLET; ORAL
ACCURETIC
PFIZER PHARMS
AB
AB
AB +
QUINAPRIL HYDROCHLORIDE
AUROBINDO PHARMA
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
MYLAN
AB
AB
AB
RANBAXY
AB
AB
AB
QUINARETIC
GAVIS PHARMS
AB
AB
AB

12.5MG;EQ 10MG BASE

12.5MG;EQ 20MG BASE
25MG;EQ 20MG BASE
AND HYDROCHLOROTHIAZIDE
12.5MG;EQ 10MG BASE
12.5MG;EQ 20MG BASE
25MG;EQ 20MG BASE
12.5MG;10MG
12.5MG;20MG
25MG;20MG
12.5MG;EQ 10MG BASE
12.5MG;EQ 20MG BASE
25MG;EQ 20MG BASE
12.5MG;EQ 10MG BASE
12.5MG;EQ 20MG BASE
25MG;EQ 20MG BASE

N020125 001
N020125 002
N020125 003

Dec 28, 1999

Dec 28, 1999
Dec 28, 1999

A078450
A078450
A078450
A201356
A201356
A201356
A077093
A077093
A077093
A078211
A078211
A078211

Aug
Aug
Aug
Apr
Apr
Apr
Mar
Mar
Mar
Mar
Mar
Mar

12.5MG;EQ 10MG BASE

12.5MG;EQ 20MG BASE
25MG;EQ 20MG BASE

A076374 001
A076374 002
A076374 003

Mar 31, 2004

Mar 31, 2004
Mar 31, 2004

N012616 004

Dec 30, 1982

A089534 001
A086513 001
A087398 001

Jul 02, 1987

N012616 005

Dec 30, 1982

N021162 001
N021162 002
N021162 003

Nov 17, 2000

Nov 17, 2000
Apr 19, 2004

N016042 003

Mar 03, 1994

A075052
A074259
A201407
A074701
A074821

Jun
Mar
Dec
Jun
Jun

001
002
003
001
002
003
001
002
003
001
002
003

24,
24,
24,
20,
20,
20,
28,
28,
28,
04,
04,
04,

2007
2007
2007
2011
2011
2011
2005
2005
2005
2009
2009
2009

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

AB
AB
AB
AB
XX

TABLET; ORAL
ALDACTAZIDE
GD SEARLE LLC
25MG;25MG
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
MUTUAL PHARM
25MG;25MG
MYLAN
25MG;25MG
WATSON LABS
25MG;25MG
ALDACTAZIDE
+ GD SEARLE LLC
50MG;50MG

HYDROCHLOROTHIAZIDE; TELMISARTAN
TABLET; ORAL
MICARDIS HCT
BOEHRINGER INGELHEIM
XX
XX
XX +

12.5MG;40MG
12.5MG;80MG
25MG;80MG

HYDROCHLOROTHIAZIDE; TRIAMTERENE

AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
DYAZIDE
+ GLAXOSMITHKLINE LLC
25MG;37.5MG
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
DURAMED PHARMS BARR
25MG;37.5MG
IVAX SUB TEVA PHARMS 25MG;50MG
LANNETT HOLDINGS INC 25MG;37.5MG
MYLAN
25MG;37.5MG
SANDOZ
25MG;37.5MG

001
001
001
001
001

18,
30,
09,
07,
05,

1999
1995
2011
1996
1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 219 (of 424)

HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE; ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
AB + SANDOZ
25MG;50MG
TABLET; ORAL
MAXZIDE
AB + MYLAN BERTEK
50MG;75MG
MAXZIDE-25
MYLAN BERTEK
AB
25MG;37.5MG
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
APOTEX INC
AB
25MG;37.5MG
AB
50MG;75MG
PLIVA
AB
25MG;37.5MG
AB
50MG;75MG
SANDOZ
AB
25MG;37.5MG
AB
50MG;75MG
WATSON LABS
AB
25MG;37.5MG
AB
50MG;75MG
AB
50MG;75MG

A073191 001

Jul 31, 1991

N019129 001

Oct 22, 1984

N019129 003

May 13, 1988

A071251
A071251
A074026
A073467
A073281
A072011
A073449
A071851
A071969

002
001
001
001
001
001
001
001
001

May
Apr
Apr
Jan
Apr
Jun
Sep
Nov
Apr

05,
17,
26,
31,
30,
17,
23,
30,
17,

1998
1988
1996
1996
1992
1988
1993
1988
1988

N020818
N020818
N020818
N020818
N020818

001
002
004
003
005

Mar
Mar
Apr
Jan
Apr

06,
06,
28,
17,
28,

1998
1998
2006
2002
2006

A076642
A076642
A076023
A077727
A077723
A077723
A077454
A076604

002
001
001
001
001
002
001
001

Mar
Oct
Apr
Nov
Nov
Nov
Jun
Dec

18,
12,
11,
06,
06,
06,
23,
31,

2004
2004
2003
2006
2006
2006
2010
2003

HYDROCHLOROTHIAZIDE; VALSARTAN
TABLET; ORAL
DIOVAN HCT
NOVARTIS
XX
XX
XX
XX
XX +

12.5MG;80MG
12.5MG;160MG
12.5MG;320MG
25MG;160MG
25MG;320MG

HYDROCODONE BITARTRATE; IBUPROFEN

TABLET; ORAL
HYDROCODONE BITARTRATE AND IBUPROFEN
AMNEAL PHARMS NY
AB
5MG;200MG
AB
7.5MG;200MG
TEVA
AB
7.5MG;200MG
VINTAGE PHARMS
AB
5MG;200MG
AB
7.5MG;200MG
AB
10MG;200MG
WATSON LABS FLORIDA
AB
5MG;200MG
AB
7.5MG;200MG
VICOPROFEN
AB + ABBOTT
7.5MG;200MG
REPREXAIN
AMNEAL PHARMS NY
2.5MG;200MG
XX
10MG;200MG
XX

N020716 001

Sep 23, 1997

A076642 003
A076642 004

Oct 19, 2007

Oct 19, 2007

5MG/5ML;60MG/5ML

N022442 001

Jun 08, 2011

1%

A080706 006

2.5%

A088250 001

Jun 06, 1984

1%
2.5%

A087795 001
A089682 001

May 03, 1983

Mar 10, 1988

HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION; ORAL

REZIRA

XX + CYPRESS PHARM

HYDROCORTISONE
CREAM; TOPICAL
ALA-CORT
CROWN LABS
AT
ANUSOL HC
SALIX PHARMS
AT
HYDROCORTISONE
ACTAVIS MID ATLANTIC
AT
AT

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 220 (of 424)

HYDROCORTISONE

AT
AT
AT
AT
AT
AT
AT
AT
AT

CREAM; TOPICAL
HYDROCORTISONE
+ FOUGERA
+
LYNE
PERRIGO NEW YORK
TARO
VINTAGE PHARMS
SYNACORT
MEDICIS

ENEMA; RECTAL
COLOCORT
PADDOCK LLC
AB
CORTENEMA
AB + ANI PHARMS
HYDROCORTISONE
TEVA PHARMS
AB

AT
AT
AT
AT
AT
AT
AT
AT
XX

AT
AT
AT
AT
AT
AT

LOTION; TOPICAL
ALA-CORT
CROWN LABS
HYDROCORTISONE
+ ALTANA
TARO
VINTAGE PHARMS
NUTRACORT
CORIA
STIE-CORT
PERRIGO
ALA-SCALP

CROWN LABS

1%
2.5%
2.5%
2.5%
1%
2.5%
2.5%

A080693
A089414
A040879
A085025
A086155
A088799
A040503

1%
2.5%

A087458 001
A087457 001

100MG/60ML

A075172 001

100MG/60ML

N016199 001

100MG/60ML

A074171 001

1%

A083201 001

2.5%
2.5%
2.5%

A040351 001
A040247 001
A040417 001

Jul 25, 2000

Jul 23, 1999
Jul 30, 2003

1%
2.5%

A080443 003
A087644 001

Aug 24, 1982

1%
2.5%

A089066 001
A089074 001

Nov 25, 1985

Nov 26, 1985

2%

A083231 001

OINTMENT; TOPICAL
HYDROCORTISONE
ACTAVIS MID ATLANTIC
+ ALTANA
+ FOUGERA
PERRIGO NEW YORK
TARO

Dec 16, 1986

Aug 20, 2010

Nov 09, 1984

Mar 12, 2004

Dec 03, 1999

May 27, 1994

Oct 13, 1982

1%
1%
2.5%
2.5%
1%
2.5%
HYDROCORTISONE IN ABSORBASE
CAROLINA MEDCL
1%

001
001
001
001
001
001

Dec 29, 2000

A088138 001

Sep 06, 1985

POWDER; FOR RX COMPOUNDING

HYDRO-RX

100%
XX + X GEN PHARMS

A085982 001

SOLUTION; TOPICAL

TEXACORT

XX + MISSION PHARMA

2.5%

A081271 001

5MG
10MG
20MG

N008697 003
N008697 001
N008697 002

5MG
10MG

A040646 001
A040646 002

AT

TABLET; ORAL
CORTEF
PHARMACIA AND UPJOHN
AB
AB
AB +
HYDROCORTISONE
COREPHARMA
AB
AB

A087796
A080692
A081203
A085027
A086257
A040310

003
001
001
001
001
001
001

May 28, 1993

Apr 17, 1992

Mar 30, 2007

Mar 30, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 221 (of 424)

HYDROCORTISONE
TABLET; ORAL
HYDROCORTISONE
COREPHARMA
AB
VINTAGE
AB
AB
AB
HYDROCORTISONE
BP
WEST WARD

Mar
Jul
Jul
Jul

30,
16,
16,
16,

2007
2007
2007
2007

20MG
5MG
10MG
20MG

A040646
A040761
A040761
A040761

20MG

A083365 001

10%

N017351 001

Feb 10, 1982

A040259 001

Jul 29, 1999

A040398 001
A040396 001

Mar 29, 2002

Feb 27, 2001

003
001
002
003

HYDROCORTISONE ACETATE
AEROSOL, METERED; RECTAL

CORTIFOAM

XX + MEDA PHARMS

CREAM; TOPICAL

HYDROCORTISONE ACETATE

2.5%

XX + FERNDALE LABS
MICORT-HC

2%

XX + FERNDALE LABS
2.5%

XX
PASTE; TOPICAL

ORABASE HCA

COLGATE
XX

0.5%

A083205 001

POWDER; FOR RX COMPOUNDING

HYDROCORTISONE ACETATE

X GEN PHARMS
100%

XX

A085981 001

HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

CREAM; TOPICAL

CORTISPORIN

XX + 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%
PROCTOFOAM HC
BX
MEDA PHARMS
1%;1%

A086195 001

CREAM; TOPICAL

PRAMOSONE

FERNDALE LABS
XX
XX

0.5%;1%

1%;1%

A083778 001

A085368 001

LOTION; TOPICAL

PRAMOSONE

FERNDALE LABS
XX
XX

1%;1%

2.5%;1%

A085980 001

A085979 001

A086457 001

HYDROCORTISONE ACETATE; UREA

CREAM; TOPICAL
CARMOL HC
NYCOMED US
AT
U-CORT
TARO
AT

1%;10%

A080505 001

1%;10%

A089472 001

Jun 13, 1988

A076654 001

Aug 03, 2005

HYDROCORTISONE BUTYRATE
CREAM; TOPICAL
HYDROCORTISONE BUTYRATE
TARO PHARM INDS
AB
0.1%

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 222 (of 424)

HYDROCORTISONE BUTYRATE
CREAM; TOPICAL
LOCOID
AB + TRIAX PHARMS LLC
LOCOID LIPOCREAM
XX + TRIAX PHARMS LLC

0.1%

N018514 001

Mar 31, 1982

0.1%

N020769 001

Sep 08, 1997

LOTION; TOPICAL

LOCOID

XX + TRIAX PHARMS LLC

0.1%

N022076 001

May 18, 2007

OINTMENT; TOPICAL
HYDROCORTISONE BUTYRATE
TARO
AB
0.1%
LOCOID
AB + TRIAX PHARMS LLC
0.1%

A076842 001

Dec 27, 2004

N018652 001

Oct 29, 1982

A076364 001

Jan 14, 2004

N019116 001

Feb 25, 1987

N020453 001

Feb 28, 1997

EQ 100MG BASE/VIAL

A040666 001

Apr 06, 2006

EQ
EQ
EQ
EQ

N009866
N009866
N009866
N009866

SOLUTION; TOPICAL
HYDROCORTISONE BUTYRATE
TARO PHARM INDS
AT
0.1%
LOCOID
AT + TRIAX PHARMS LLC
0.1%

HYDROCORTISONE PROBUTATE
CREAM; TOPICAL

PANDEL

XX + FOUGERA PHARMS

0.1%

HYDROCORTISONE SODIUM SUCCINATE

AP
AP
AP
AP
AP

INJECTABLE; INJECTION
A-HYDROCORT
HOSPIRA
SOLU-CORTEF
+ PHARMACIA AND UPJOHN
+
+
+

100MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL

001
002
003
004

HYDROCORTISONE VALERATE
CREAM; TOPICAL
HYDROCORTISONE VALERATE
PERRIGO NEW YORK
AB
0.2%
TARO
AB
0.2%
WESTCORT
AB + RANBAXY
0.2%
OINTMENT; TOPICAL
HYDROCORTISONE VALERATE
ALTANA
AB
0.2%
TARO
AB
0.2%
WESTCORT
AB + RANBAXY
0.2%

A075666 001
A075042 001

May 24, 2000

Aug 25, 1998

N017950 001

A075085 001
A075043 001

Jul 31, 2001

Aug 25, 1998

N018726 001

Aug 08, 1983

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

AT
AT
AT
AT

SOLUTION/DROPS; OTIC
CORTISPORIN
+ MONARCH PHARMS
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
ALCON
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
BAUSCH AND LOMB
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
LUITPOLD
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

N050479 001
A062423 001
A064053 001
A065216 001

Aug 25, 1983

Dec 29, 1995
Oct 31, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 223 (of 424)

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SUSPENSION/DROPS; OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

XX + ALCON UNIVERSAL
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

AT
AT
AT
AT
AT

SUSPENSION/DROPS; OTIC
CORTISPORIN
+ MONARCH PHARMS
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
ALCON UNIVERSAL
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
LUITPOLD
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
OTICAIR
BAUSCH AND LOMB
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
PEDIOTIC
MONARCH PHARMS
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

A062874 001

May 11, 1988

A060613 001
A062488 001
A065219 001

Nov 06, 1985

May 01, 2006

A064065 001

Aug 28, 1996

A062822 001

Sep 29, 1987

HYDROFLUMETHIAZIDE
TABLET; ORAL
SALURON
AB + SHIRE

50MG

N011949 001

HYDROMORPHONE HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
XX

INJECTABLE; INJECTION
DILAUDID
+ PURDUE PHARM PRODS
1MG/ML
2MG/ML
+
4MG/ML
+
DILAUDID-HP
+ PURDUE PHARM PRODS
10MG/ML
HYDROMORPHONE HYDROCHLORIDE
AKORN
10MG/ML
10MG/ML
BARR
10MG/ML
HOSPIRA
10MG/ML
HOSPIRA INC
1MG/ML
2MG/ML
4MG/ML
10MG/ML
DILAUDID-HP
+ PURDUE PHARM PRODS
250MG/VIAL

SOLUTION; ORAL
DILAUDID
AA + PURDUE PHARM PRODS
5MG/5ML
HYDROMORPHONE HYDROCHLORIDE
ROXANE
AA
5MG/5ML
TABLET; ORAL
DILAUDID
PURDUE PHARM PRODS
AB
2MG
AB
4MG
AB +
8MG
HYDROMORPHONE HYDROCHLORIDE
ELITE LABS
8MG
AB
LANNETT
2MG
AB
4MG
AB
8MG
AB
MALLINCKRODT
8MG
AB
MALLINCKRODT INC
2MG
AB
4MG
AB
NESHER PHARMS
2MG
AB
4MG
AB
8MG
AB

N019034 003
N019034 004
N019034 005

Apr 30, 2009

Apr 30, 2009
Apr 30, 2009

N019034 001

Jan 11, 1984

A078228
A078261
A076444
A074598
N200403
N200403
N200403
A078591

Apr
Apr
Apr
Jun
Dec
Dec
Dec
Jun

001
001
001
001
001
002
003
001

14,
14,
25,
19,
01,
01,
01,
17,

2010
2010
2003
1997
2011
2011
2011
2008

N019034 002

Aug 04, 1994

N019891 001

Dec 07, 1992

A074653 001

Jul 29, 1998

N019892 003
N019892 002
N019892 001

Nov 09, 2007

Nov 09, 2007
Dec 07, 1992

A076723
A078439
A078439
A077471
A076855
A078273
A078273
A077311
A077311
A077311

Oct
Dec
Dec
Dec
Dec
Sep
Sep
Nov
Nov
Nov

001
001
002
001
001
001
002
001
002
003

18,
09,
09,
09,
23,
19,
19,
09,
09,
09,

2005
2009
2009
2009
2004
2007
2007
2005
2005
2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 224 (of 424)

HYDROMORPHONE HYDROCHLORIDE
TABLET; ORAL
HYDROMORPHONE HYDROCHLORIDE
ROXANE
AB
4MG
AB
8MG

A074597 003
A074597 001

May 29, 2009

Jul 29, 1998

TABLET, EXTENDED RELEASE; ORAL

EXALGO
MALLINCKRODT INC
8MG
XX
12MG
XX
16MG
XX +

N021217 001
N021217 002
N021217 003

Mar 01, 2010

Mar 01, 2010
Mar 01, 2010

5GM/VIAL (5GM/KIT)

N022041 001

Apr 08, 2011

1MG/ML

A085998 001

HYDROXOCOBALAMIN
INJECTABLE; INJECTION

CYANOKIT

XX + MERCK SANTE SAS

HYDROXOCOBALAMIN
XX + WATSON LABS

HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE

SOLUTION/DROPS; OPHTHALMIC

PAREMYD

XX + AKORN
1%;0.25%

N019261 001

Jan 30, 1992

A040766
A040274
A040104
A040150
A040081
A040133
A040760
A040657

Jun
May
Nov
Jan
Sep
Nov
Aug
Sep

HYDROXYCHLOROQUINE SULFATE
TABLET; ORAL
HYDROXYCHLOROQUINE SULFATE
IPCA LABS LTD
AB
200MG
MYLAN
AB
200MG
SANDOZ
AB
200MG
AB
200MG
TEVA PHARMS
AB
200MG
WATSON LABS
AB
200MG
WEST WARD
AB
200MG
ZYDUS PHARMS USA INC 200MG
AB
PLAQUENIL
AB + SANOFI AVENTIS US
200MG

001
001
001
001
001
001
001
001

14,
29,
30,
27,
30,
30,
15,
21,

2007
1998
1995
1996
1994
1995
2007
2007

N009768 001

HYDROXYPROGESTERONE CAPROATE
SOLUTION; INTRAMUSCULAR

MAKENA

XX + KV PHARM

1250MG/5ML (250MG/ML)

N021945 001

5MG

N018771 001

500MG

N016295 001

500MG
500MG

A075143 001
A075340 001

Oct 16, 1998

Feb 24, 1999

200MG
300MG
400MG

N016295 002
N016295 003
N016295 004

Feb 25, 1998

Feb 25, 1998
Feb 25, 1998

Feb 03, 2011

HYDROXYPROPYL CELLULOSE
INSERT; OPHTHALMIC

LACRISERT

XX + ATON

HYDROXYUREA

AB
AB
AB
XX
XX
XX

CAPSULE; ORAL
HYDREA
+ BRISTOL MYERS SQUIBB
HYDROXYUREA
BARR
PAR PHARM
DROXIA
BRISTOL MYERS SQUIBB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 225 (of 424)

HYDROXYZINE HYDROCHLORIDE

AP
AP
AP
AP

INJECTABLE; INJECTION
HYDROXYZINE HYDROCHLORIDE
+ APP PHARMS
25MG/ML
+
50MG/ML
LUITPOLD
25MG/ML
50MG/ML

SYRUP; ORAL
HYDROXYZINE HYDROCHLORIDE
AA + HI TECH PHARMA
10MG/5ML
AA + VINTAGE PHARMS
10MG/5ML
AA + WOCKHARDT
10MG/5ML

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
HYDROXYZINE HYDROCHLORIDE
AMNEAL PHARM
10MG
25MG
50MG
HERITAGE PHARMS INC
10MG
25MG
50MG
HETERO LABS UNIT III 10MG
25MG
50MG
INVAGEN PHARMS
10MG
25MG
50MG
KVK TECH
10MG
25MG
50MG
MUTUAL PHARM
10MG
25MG
50MG
MYLAN
10MG
25MG
50MG
NORTHSTAR HLTHCARE
10MG
25MG
50MG
+ PLIVA
10MG
+
25MG
+
50MG
SUN PHARM INDS INC
10MG
25MG
50MG
VINTAGE PHARMS
10MG
25MG
50MG
WATSON LABS
10MG
10MG
25MG
25MG
50MG
50MG

A087329
A087329
A087408
A087408

001
002
001
002

A040010 001
A040391 001
A087294 001

Oct 28, 1994

Apr 10, 2002
Apr 12, 1982

A040808
A040808
A040808
A040804
A040804
A040804
A040805
A040805
A040805
A040812
A040812
A040812
A040786
A040787
A040788
A089381
A089382
A089383
A091176
A091176
A091176
A040841
A040842
A040840
A088617
A088618
A088619
A040899
A040899
A040899
A040579
A040574
A040580
A081149
A088348
A081150
A088349
A081151
A088350

Sep
Sep
Sep
Jun
Jun
Jun
May
May
May
Mar
Mar
Mar
Mar
Mar
Mar
May
May
May
Jun
Jun
Jun
Mar
Mar
Mar
Jan
Jan
Jan
Jun
Jun
Jun
May
May
May
Mar
Sep
Mar
Sep
Mar
Sep

001
002
003
001
002
003
001
002
003
001
002
003
001
001
001
001
001
001
001
002
003
001
001
001
001
001
001
001
002
003
001
001
001
001
001
001
001
001
001

24,
24,
24,
30,
30,
30,
29,
29,
29,
12,
12,
12,
20,
20,
20,
19,
19,
19,
07,
07,
07,
31,
31,
31,
10,
10,
10,
10,
10,
10,
27,
27,
27,
18,
15,
18,
15,
18,
15,

2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2007
2007
2007
1986
1986
1986
2010
2010
2010
2008
2008
2008
1986
1986
1986
2008
2008
2008
2005
2005
2005
1994
1983
1994
1983
1994
1983

HYDROXYZINE PAMOATE
CAPSULE; ORAL
HYDROXYZINE PAMOATE
BARR
AB
AB
SANDOZ
AB

EQ 25MG HCL
EQ 50MG HCL
EQ 25MG HCL

A088496 001
A088487 001
A087479 001

Jun 15, 1984

Jun 15, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 226 (of 424)

HYDROXYZINE PAMOATE
CAPSULE; ORAL
HYDROXYZINE PAMOATE
SANDOZ
AB
WATSON LABS
AB
AB
AB
VISTARIL
PFIZER
AB
AB +
HYDROXYZINE PAMOATE
BARR
XX

EQ 25MG HCL
EQ 50MG HCL

N011459 002
N011459 004

EQ 100MG HCL

A088488 001

SUSPENSION; ORAL

VISTARIL

XX + PFIZER

EQ 25MG HCL/5ML

N011795 001

INJECTABLE; INTRAVENOUS

BONIVA

XX + ROCHE

EQ 3MG BASE/3ML

N021858 001

Jan 06, 2006

TABLET; ORAL

BONIVA

XX + ROCHE

EQ 150MG BASE

N021455 002

Mar 24, 2005

SOLUTION; INTRAVENOUS
CALDOLOR
CUMBERLAND PHARMS
XX
XX +

400MG/4ML (100MG/ML)
800MG/8ML (100MG/ML)

N022348 001
N022348 002

Jun 11, 2009

Jun 11, 2009

SUSPENSION; ORAL
IBUPROFEN
AB + ACTAVIS MID ATLANTIC
PERRIGO R AND D
AB

100MG/5ML
100MG/5ML

A074978 001
A076925 001

Mar 25, 1998

Sep 23, 2004

TABLET; ORAL
IBUPROFEN
AMNEAL PHARMS NY
AB
AB
AB
AB
AB
AB
CONTRACT PHARMACAL
AB
AB
AB
DR REDDYS LA
AB
AB
AB +
DR REDDYS LABS INC
AB
AB
AB
MARKSANS PHARMA
AB
AB
AB
NORTHSTAR HLTHCARE
AB
AB
AB
OHM LABS
AB
PERRIGO R AND D
AB
AB

400MG
400MG
600MG
600MG
800MG
800MG
400MG
600MG
800MG
400MG
600MG
800MG
400MG
600MG
800MG
400MG
600MG
800MG
400MG
600MG
800MG
400MG
400MG
600MG

A071334
A078558
A071335
A078558
A071935
A078558
A071267
A071268
A072300
A075682
A075682
A075682
A076112
A076112
A076112
A090796
A090796
A090796
A078132
A078132
A078132
A070818
A077114
A077114

Nov
Jun
Nov
Jun
Oct
Jun
Oct
Oct
Jul
Nov
Nov
Nov
Oct
Oct
Oct
Dec
Dec
Dec
Sep
Sep
Sep
Dec
Jul
Jul

EQ
EQ
EQ
EQ

50MG
25MG
25MG
50MG

HCL
HCL
HCL
HCL

A086183
A040156
A081165
A040156

001
001
001
002

Jul 15, 1996

Jul 31, 1991
Jul 15, 1996

Jun 15, 1984

IBANDRONATE SODIUM

IBUPROFEN

001
001
001
002
001
003
001
001
001
001
002
003
001
002
003
001
002
003
001
002
003
001
001
002

25,
18,
25,
18,
13,
18,
15,
15,
01,
14,
14,
14,
31,
31,
31,
21,
21,
21,
10,
10,
10,
26,
18,
18,

1986
2007
1986
2007
1987
2007
1986
1986
1988
2001
2001
2001
2001
2001
2001
2010
2010
2010
2007
2007
2007
1985
2005
2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 227 (of 424)

IBUPROFEN
TABLET; ORAL
IBUPROFEN
PERRIGO R AND D
AB
SHASUN USA
AB
AB
AB
VINTAGE PHARMS
AB
AB
AB
AB
AB
WATSON LABS
AB
AB
IBU-TAB
ALRA
AB
AB

003
001
002
003
001
001
001
001
001
001
001

Jul
Feb
Feb
Feb
Oct
Oct
Feb
Oct
Nov
Aug
Aug

18,
05,
05,
05,
22,
22,
01,
22,
18,
21,
21,

2005
2009
2009
2009
1986
1986
1988
1986
1987
1985
1985

800MG
400MG
600MG
800MG
300MG
400MG
400MG
600MG
800MG
400MG
600MG

A077114
A078329
A078329
A078329
A071230
A071231
A071644
A071232
A072004
A070436
A070437

400MG
600MG

A071058 001
A071059 001

Aug 11, 1988

Aug 11, 1988

EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

N021903 001

Apr 13, 2006

AND IBUPROFEN
400MG;5MG
400MG;5MG
400MG;5MG

A078769 001
A078316 001
A078394 001

Jan 04, 2008

Nov 29, 2007
Nov 26, 2007

0.1MG/ML

N020491 001

Dec 28, 1995

0.1MG/ML
0.1MG/ML
0.1MG/ML

A090643 001
A090924 001
A090240 001

Jan 11, 2010

Jan 11, 2010
Jan 11, 2010

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

N022150 001

Aug 25, 2011

N021321 001

Dec 20, 2002

N050734 001

Feb 17, 1997

A065440
A065275
A065288
A091293

Aug
Dec
May
Mar

IBUPROFEN LYSINE
INJECTABLE; INTRAVENOUS

NEOPROFEN

XX + LUNDBECK INC

IBUPROFEN; OXYCODONE HYDROCHLORIDE

TABLET; ORAL
OXYCODONE HYDROCHLORIDE
ACTAVIS ELIZABETH
AB
AB + BARR LABS INC
WATSON LABS
AB

IBUTILIDE FUMARATE
INJECTABLE; INJECTION
CORVERT
AP + PHARMACIA AND UPJOHN
IBUTILIDE FUMARATE
BIONICHE PHARMA USA
AP
AP
LUITPOLD
AP

ICATIBANT ACETATE
INJECTABLE; SUBCUTANEOUS

FIRAZYR

XX + SHIRE ORPHAN THERAP

ICODEXTRIN
SOLUTION; INTRAPERITONEAL

EXTRANEAL

7.5GM/100ML
XX + BAXTER HLTHCARE

IDARUBICIN HYDROCHLORIDE

AP
AP
AP
AP
AP

INJECTABLE; INJECTION
IDAMYCIN PFS
+ PHARMACIA AND UPJOHN 1MG/ML
IDARUBICIN HYDROCHLORIDE
APP PHARMS
1MG/ML
BEDFORD LABS
1MG/ML
1MG/ML
SANDOZ
1MG/ML

001
001
001
001

04,
14,
15,
29,

2009
2006
2007
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 228 (of 424)

IDARUBICIN HYDROCHLORIDE

AP
XX
XX
XX

INJECTABLE; INJECTION
IDARUBICIN HYDROCHLORIDE PFS
TEVA PARENTERAL
1MG/ML
IDARUBICIN HYDROCHLORIDE
+ TEVA PARENTERAL
5MG/VIAL
+
10MG/VIAL
+
20MG/VIAL

A065036 001

May 01, 2002

A065037 003
A065037 002
A065037 001

May 01, 2002

May 01, 2002
May 01, 2002

IDOXURIDINE
SOLUTION/DROPS; OPHTHALMIC
DENDRID
AT + ALCON
0.1%
HERPLEX
AT + ALLERGAN
0.1%

N014169 001
N013935 002

IFOSFAMIDE
INJECTABLE; INJECTION
IFEX
BAXTER HLTHCARE
AP
AP
IFOSFAMIDE
AP + APP PHARMS
AP
AP +
AP
BEDFORD LABS
AP
AP
AP + TEVA PARENTERAL
AP +

1GM/VIAL
3GM/VIAL

N019763 001
N019763 002

Dec 30, 1988

Dec 30, 1988

1GM/VIAL
1GM/20ML (50MG/ML)
3GM/VIAL
3GM/60ML (50MG/ML)
1GM/20ML(50MG/ML)
3GM/60ML(50MG/ML)
1GM/20ML (50MG/ML)
3GM/60ML (50MG/ML)

A076078
A090181
A076078
A090181
A076619
A076619
A076657
A076657

May
Sep
May
Sep
Jun
Jun
Apr
Apr

1GM/20ML;1GM/10ML (50MG/ML;100MG/ML)
3GM/60ML;1GM/10ML (50MG/ML;100MG/ML)

A075874 001
A075874 002

Feb 26, 2002

Feb 26, 2002

1MG
2MG
4MG
6MG
8MG
10MG
12MG

N022192
N022192
N022192
N022192
N022192
N022192
N022192

May
May
May
May
May
May
May

10MCG/ML (10MCG/ML)
20MCG/ML (20MCG/ML)

N021779 002
N021779 003

Dec 08, 2005

Aug 07, 2009

EQ 100MG BASE
EQ 400MG BASE

N021588 001
N021588 002

Apr 18, 2003

Apr 18, 2003

001
001
002
002
001
002
001
002

28,
22,
28,
22,
29,
29,
04,
04,

2002
2009
2002
2009
2011
2011
2007
2007

IFOSFAMIDE; MESNA
INJECTABLE; INTRAVENOUS

IFOSFAMIDE/MESNA KIT

XX + TEVA PARENTERAL
XX +

ILOPERIDONE
TABLET; ORAL

FANAPT

XX + NOVARTIS
XX
XX
XX
XX
XX
XX

001
002
003
004
005
006
007

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

2009
2009
2009
2009
2009
2009
2009

ILOPROST
SOLUTION; INHALATION

VENTAVIS

XX + ACTELION PHARMS LTD

XX +

IMATINIB MESYLATE
TABLET; ORAL
GLEEVEC
NOVARTIS
XX
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 229 (of 424)

IMIGLUCERASE
INJECTABLE; INJECTION
CEREZYME
GENZYME
XX
XX +

200 UNITS/VIAL
400 UNITS/VIAL

N020367 001
N020367 002

May 23, 1994

Sep 22, 1999

A090443
A090442
A090441
A081048
A081049
A081050
A088292
A089422
A088262
A084936
A083745
A084937

Mar
Mar
Mar
Jun
Jun
Jun
Oct
Jul
Oct

IMIPRAMINE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
IMIPRAMINE HYDROCHLORIDE
LUPIN LTD
10MG
25MG
50MG
MUTUAL PHARM
10MG
25MG
50MG
PAR PHARM
10MG
10MG
25MG
SANDOZ
10MG
25MG
50MG
TOFRANIL
MALLINCKRODT INC
10MG
25MG
+
50MG

001
001
001
001
001
001
001
001
001
002
001
001

11,
11,
11,
05,
05,
05,
21,
14,
21,

2010
2010
2010
1990
1990
1990
1983
1987
1983

A087844 001
A087845 001
A087846 001

May 22, 1984

May 22, 1984
May 22, 1984

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

IMIPRAMINE PAMOATE
CAPSULE; ORAL
IMIPRAMINE PAMOATE
LUPIN LTD
AB
AB
AB
AB
ROXANE
AB
AB
AB
AB
TOFRANIL-PM
AB + MALLINCKRODT INC
AB
AB
AB

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

75MG HCL
100MG HCL
125MG HCL
150MG HCL
75MG HCL
100MG HCL
125MG HCL
150MG HCL

A090444
A090444
A090444
A090444
A091099
A091099
A091099
A091099

001
002
003
004
001
002
003
004

EQ
EQ
EQ
EQ

75MG HCL
100MG HCL
125MG HCL
150MG HCL

N017090
N017090
N017090
N017090

001
004
003
002

16,
16,
16,
16,
16,
16,
16,
16,

2010
2010
2010
2010
2010
2010
2010
2010

IMIQUIMOD

AB
AB
AB
AB
AB
AB
XX
XX

CREAM; TOPICAL
ALDARA
+ MEDICIS
IMIQUIMOD
NYCOMED US
PERRIGO ISRAEL
TARO
TEVA PHARMS USA
TOLMAR
ZYCLARA
+ MEDICIS
+

5%

N020723 001

Feb 27, 1997

5%
5%
5%
5%
5%

A078548
A078837
A200173
A200481
A091044

Feb
Sep
Apr
Apr
Feb

2.5%
3.75%

N022483 002
N022483 001

001
001
001
001
001

25,
07,
15,
18,
28,

2010
2010
2011
2011
2011

Jul 15, 2011

Mar 25, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 230 (of 424)

INAMRINONE LACTATE
INJECTABLE; INJECTION

AMRINONE LACTATE

XX + BEDFORD

EQ 5MG BASE/ML

A075513 001

May 09, 2000

EQ 75MCG BASE

N022383 001

Jul 01, 2011

1.25MG
2.5MG
1.25MG
2.5MG
1.25MG
2.5MG
1.25MG
2.5MG
1.25MG
2.5MG
1.25MG
2.5MG

A074722
A074722
A075105
A075105
A074299
A074299
A074461
A074461
A074594
A074594
A074585
A074585

Jun
Jun
Jul
Jul
Apr
Jul
Mar
Mar
May
May
Sep
Sep

EQ 100MG BASE
EQ 200MG BASE
EQ 400MG BASE

N020685 006
N020685 003
N020685 001

Apr 19, 2000

Mar 13, 1996
Mar 13, 1996

2mCi/0.2ML

N019862 001

Dec 29, 1992

5mCi/0.5ML

N019841 001

Sep 27, 1994

N019044 001

Dec 24, 1985

N017707 001

Feb 18, 1982

3mCi/ML

N020314 001

Jun 02, 1994

25MG/VIAL

N011525 001

INDACATEROL MALEATE
POWDER; INHALATION

ARCAPTA NEOHALER

XX + NOVARTIS

INDAPAMIDE
TABLET; ORAL
INDAPAMIDE
ACTAVIS ELIZABETH
AB
AB
ALPHAPHARM
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
MYLAN
AB
AB +
SANDOZ
AB
AB
WATSON LABS
AB
AB

001
002
001
002
002
001
002
001
001
002
001
002

17,
17,
23,
23,
29,
27,
26,
27,
23,
23,
26,
26,

1996
1996
1998
1998
1996
1995
1997
1996
1996
1996
1996
1996

INDINAVIR SULFATE
CAPSULE; ORAL
CRIXIVAN
MERCK SHARP DOHME
XX
XX
XX +

INDIUM IN-111 CHLORIDE

INJECTABLE; INJECTION

INDICLOR

XX + GE HEALTHCARE
INDIUM IN 111 CHLORIDE
XX + MALLINCKRODT

INDIUM IN-111 OXYQUINOLINE

INJECTABLE; INJECTION

INDIUM IN-111 OXYQUINOLINE

1mCi/ML
XX + GE HEALTHCARE

INDIUM IN-111 PENTETATE DISODIUM

INJECTABLE; INTRATHECAL

MPI INDIUM DTPA IN 111

1mCi/ML
XX + GE HEALTHCARE

INDIUM IN-111 PENTETREOTIDE KIT

INJECTABLE; INJECTION

OCTREOSCAN

XX + MALLINCKRODT

INDOCYANINE GREEN
INJECTABLE; INJECTION
IC-GREEN
AP + AKORN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 231 (of 424)

INDOCYANINE GREEN
INJECTABLE; INJECTION
INDOCYANINE GREEN
PULSION MEDCL
AP

25MG/VIAL

A040811 001

Nov 21, 2007

25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG

A091276
A091276
N018851
N018851
A091240
A091240
A070719
A070756
N018858
A070624
A070673
A070674
A090403
A090403

001
002
001
002
001
002
001
001
001
001
001
001
001
002

Dec
Dec
May
May
Apr
Apr
Feb
Feb
Apr
Sep
Apr
Apr
Nov
Nov

22,
22,
18,
18,
12,
12,
12,
12,
20,
04,
29,
29,
15,
15,

2010
2010
1984
1984
2011
2011
1986
1986
1984
1985
1987
1987
2010
2010

A091549
A079175
A200529
A074464

001
001
001
001

Dec
Mar
Nov
May

01,
06,
30,
28,

2010
2009
2010
1998

INDOMETHACIN
CAPSULE; ORAL
INDOMETHACIN
GLENMARK GENERICS
AB
AB
HERITAGE PHARMS INC
AB
AB
HETERO LABS UNIT III
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
MYLAN
AB
AB +
SANDOZ
AB
AB
ZYDUS PHARMS USA INC
AB
AB

AB
AB
AB
AB

CAPSULE, EXTENDED RELEASE; ORAL

INDOMETHACIN
AMNEAL PHARMS
75MG
AVANTHI INC
75MG
PADDOCK LLC
75MG
+ SANDOZ
75MG

INJECTABLE; INJECTION

INDOMETHACIN

XX + APP PHARMS

EQ 1MG BASE/VIAL

N022536 001

Mar 17, 2010

SUPPOSITORY; RECTAL

INDOMETHACIN

XX + G AND W LABS

50MG

A073314 001

Aug 31, 1992

SUSPENSION; ORAL

INDOCIN

XX + IROKO PHARMS

25MG/5ML

N018332 001

Oct 10, 1985

EQ 1MG BASE/VIAL

N018878 001

Jan 30, 1985

EQ 1MG BASE/VIAL

A078713 001

Jul 16, 2008

INDOMETHACIN SODIUM
INJECTABLE; INJECTION
INDOCIN
AP + LUNDBECK INC
INDOMETHACIN SODIUM
BEDFORD
AP

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

INJECTABLE; SUBCUTANEOUS

NOVOLOG MIX 70/30

XX + NOVO NORDISK INC

70 UNITS/ML;30 UNITS/ML

N021172 001

Nov 01, 2001

N020986 001

Jun 07, 2000

INSULIN ASPART RECOMBINANT

INJECTABLE; SUBCUTANEOUS

NOVOLOG

XX + NOVO NORDISK INC

100 UNITS/ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 232 (of 424)

INSULIN DETEMIR RECOMBINANT

INJECTABLE; SUBCUTANEOUS

LEVEMIR

XX + NOVO NORDISK INC

100 UNITS/ML

N021536 001

Jun 16, 2005

N021081 001

Apr 20, 2000

INJECTABLE; IV (INFUSION)-SC

APIDRA

XX + SANOFI AVENTIS US
1000 UNITS/10ML (100 UNITS/ML)
XX +
300 UNITS/3ML (100 UNITS/ML)

N021629 001
N021629 002

Apr 16, 2004

Dec 20, 2005

INJECTABLE; SUBCUTANEOUS
APIDRA SOLOSTAR
XX
SANOFI AVENTIS US

N021629 003

Feb 24, 2009

INSULIN GLARGINE RECOMBINANT

INJECTABLE; INJECTION

LANTUS

XX + SANOFI AVENTIS US

100 UNITS/ML

INSULIN GLULISINE RECOMBINANT

300 UNITS/3ML

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

XX
XX
XX
XX
XX
XX

INJECTABLE; INJECTION

HUMALOG MIX 50/50

+ LILLY
50
HUMALOG MIX 50/50 KWIKPEN
+ LILLY
50
HUMALOG MIX 50/50 PEN
+ LILLY
50
HUMALOG MIX 75/25
+ LILLY
75
HUMALOG MIX 75/25 KWIKPEN
+ LILLY
75
HUMALOG MIX 75/25 PEN
+ LILLY
75

UNITS/ML;50 UNITS/ML

N021018 001

Dec 22, 1999

UNITS/ML;50 UNITS/ML

N021018 002

Sep 06, 2007

UNITS/ML;50 UNITS/ML

N021018 003

Dec 22, 1999

UNITS/ML;25 UNITS/ML

N021017 001

Dec 22, 1999

UNITS/ML;25 UNITS/ML

N021017 002

Sep 06, 2007

UNITS/ML;25 UNITS/ML

N021017 003

Dec 22, 1999

100 UNITS/ML

N020563 001

Jun 14, 1996

100 UNITS/ML

N020563 003

Sep 06, 2007

100 UNITS/ML

N020563 002

Aug 06, 1998

500 UNITS/ML

N018780 004

Mar 31, 1994

10MCI/5ML (2MCI/ML)

N022290 001

Sep 19, 2008

52%

N009321 003

INSULIN LISPRO RECOMBINANT

INJECTABLE; INJECTION

HUMALOG

XX + LILLY
HUMALOG KWIKPEN
XX + LILLY
HUMALOG PEN
XX + LILLY

INSULIN RECOMBINANT HUMAN

INJECTABLE; INJECTION

HUMULIN R

XX + LILLY

IOBENGUANE SULFATE I-123

SOLUTION; INTRAVENOUS

ADREVIEW

XX + GE HEALTHCARE

IODIPAMIDE MEGLUMINE
INJECTABLE; INJECTION

CHOLOGRAFIN MEGLUMINE

XX + BRACCO

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 233 (of 424)

IODIXANOL
INJECTABLE; INJECTION

VISIPAQUE 270

XX + GE HEALTHCARE
XX
VISIPAQUE 320
XX + GE HEALTHCARE
XX

55%
55%

N020351 001
N020808 001

Mar 22, 1996

Aug 29, 1997

65.2%
65.2%

N020351 002
N020808 002

Mar 22, 1996

Aug 29, 1997

5MCI/2.5ML (2MCI/ML)

N022454 001

Jan 14, 2011

30.2%

N018956 005

Nov 30, 1988

SOLUTION; INJECTION, ORAL

OMNIPAQUE 350

XX + GE HEALTHCARE
75.5%
XX
75.5%

N018956 004
N020608 003

Dec 26, 1985

Oct 24, 1995

N018956 001

Dec 26, 1985

N018956 002
N020608 001

Dec 26, 1985

Oct 24, 1995

N018956 003
N020608 002

Dec 26, 1985

Oct 24, 1995

51%

A074679 001

Apr 02, 1997

61%

A074679 002

Apr 02, 1997

76%

A074679 003

Apr 02, 1997

41%

N018735 006

Jul 07, 1987

51%
51%

N018735 007
N020327 002

Jul 06, 1992

Oct 12, 1994

61%
61%

N018735 002
N020327 003

Dec 31, 1985

Oct 12, 1994

76%
76%

N018735 003
N020327 004

Dec 31, 1985

Oct 12, 1994

61%

A090394 001

Jun 18, 2010

76%

A090394 002

Jun 18, 2010

41%

N018735 001

Dec 31, 1985

61%

N018735 004

Dec 31, 1985

IOFLUPANE I-123
SOLUTION; INTRAVENOUS

DATSCAN

XX + GE HLTHCARE INC

IOHEXOL
INJECTABLE; INJECTION

OMNIPAQUE 140

XX + GE HEALTHCARE

SOLUTION; INJECTION, ORAL, RECTAL

OMNIPAQUE 180

XX + GE HEALTHCARE
38.8%
OMNIPAQUE 240
XX + GE HEALTHCARE
51.8%
XX
51.8%
OMNIPAQUE 300
XX + GE HEALTHCARE
64.7%
XX
64.7%

IOPAMIDOL

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
XX
XX

INJECTABLE; INJECTION
IOPAMIDOL-250
APP PHARMS
IOPAMIDOL-300
APP PHARMS
IOPAMIDOL-370
APP PHARMS
ISOVUE-200
+ BRACCO
ISOVUE-250
+ BRACCO
+
ISOVUE-300
+ BRACCO
+
ISOVUE-370
+ BRACCO
+
SCANLUX-300
SANOCHEMIA CORP USA
SCANLUX-370
SANOCHEMIA CORP USA
ISOVUE-M 200
+ BRACCO
ISOVUE-M 300
+ BRACCO

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 234 (of 424)

IOPROMIDE

XX
XX
XX
XX
XX
XX
XX
XX

INJECTABLE; INJECTION

ULTRAVIST (PHARMACY BULK)

+ BAYER HLTHCARE
49.9%
+
62.3%
+
76.9%
ULTRAVIST 150
+ BAYER HLTHCARE
31.2%
ULTRAVIST 240
+ BAYER HLTHCARE
49.9%
ULTRAVIST 300
+ BAYER HLTHCARE
62.3%
ULTRAVIST 300 IN PLASTIC CONTAINER
+ BAYER HLTHCARE
62.3%
ULTRAVIST 370
+ BAYER HLTHCARE
76.9%

N021425 003
N021425 001
N021425 002

Mar 12, 2004

Sep 20, 2002
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

IOTHALAMATE MEGLUMINE
INJECTABLE; INJECTION

CONRAY

XX + MALLINCKRODT
CONRAY 30

XX + MALLINCKRODT
CONRAY 43

XX + MALLINCKRODT
SOLUTION; INTRAVESICAL

CYSTO-CONRAY II

MALLINCKRODT
XX

60%

N013295 001

30%

N016983 001

43%

N013295 002

17.2%

N017057 002

51%

N019710 002

Dec 30, 1988

64%
64%

N019710 004
N020923 004

Jan 22, 1992

May 13, 1999

68%

N019710 001

Dec 30, 1988

74%
74%

N019710 005
N020923 003

Jan 22, 1992

May 28, 1998

39.3%;19.6%

N018905 002

Jul 26, 1985

62%

N020316 001

Dec 21, 1995

73%

N020316 002

Dec 21, 1995

N021527 001

Nov 27, 2004

IOVERSOL

XX
XX
XX
XX
XX
XX

INJECTABLE; INJECTION

OPTIRAY 240

+ MALLINCKRODT
OPTIRAY 300
+ MALLINCKRODT
+
OPTIRAY 320
+ MALLINCKRODT
OPTIRAY 350
+ MALLINCKRODT
+

IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM

INJECTABLE; INJECTION

HEXABRIX

XX + GUERBET

IOXILAN
INJECTABLE; INJECTION
OXILAN-300
GUERBET
XX
OXILAN-350
GUERBET
XX

IPRATROPIUM BROMIDE
AEROSOL, METERED; INHALATION

ATROVENT HFA

XX + BOEHRINGER INGELHEIM 0.021MG/INH

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 235 (of 424)

IPRATROPIUM BROMIDE

AN
AN
AN
AN
AN
AN
AN
AN

SOLUTION; INHALATION
IPRATROPIUM BROMIDE
BAUSCH AND LOMB
+ DEY
LANDELA PHARM
NEPHRON
NOVEX
RITEDOSE CORP
TEVA PARENTERAL
WATSON LABS

SPRAY, METERED; NASAL

ATROVENT
AB + BOEHRINGER INGELHEIM
AB +
IPRATROPIUM BROMIDE
BAUSCH AND LOMB
AB
AB
DEY
AB
AB
NOVEX
AB
AB
ROXANE
AB
AB

001
001
001
001
001
001
001
001

Oct
Jan
Jul
Sep
Mar
Jan
Feb
May

15,
10,
19,
27,
28,
26,
07,
09,

2001
1997
2005
2001
2001
2001
2000
2005

0.02%
0.02%
0.02%
0.02%
0.02%
0.02%
0.02%
0.02%

A075835
A074755
A077072
A075562
A075441
A075693
A075313
A076291

0.021MG/SPRAY
0.042MG/SPRAY

N020393 001
N020394 001

Oct 20, 1995

Oct 20, 1995

0.021MG/SPRAY
0.042MG/SPRAY
0.021MG/SPRAY
0.042MG/SPRAY
0.021MG/SPRAY
0.042MG/SPRAY
0.021MG/SPRAY
0.042MG/SPRAY

A076025
A076103
A075552
A075553
A076156
A076155
A076664
A076598

Mar
Mar
Mar
Mar
Apr
Apr
Nov
Nov

75MG
150MG
300MG

N020757 001
N020757 002
N020757 003

Sep 30, 1997

Sep 30, 1997
Sep 30, 1997

N020571 001
N020571 002

Jun 14, 1996

Jun 14, 1996

A079068
A079068
A078589
A078589
A090726
A090726
A077776
A077776
A078753
A078753
A090393
A090393
A078953
A078953
A090137
A090137
A078188
A078188
A091032
A091032
A077915
A077915

Nov
Nov
Feb
Feb
Sep
Sep
Feb
Feb
Dec
Dec
May
May
Apr
Apr
Nov
Nov
Feb
Feb
Dec
Dec
Feb
Feb

001
001
001
001
001
001
001
001

31,
31,
31,
31,
18,
18,
05,
05,

2003
2003
2003
2003
2003
2003
2003
2003

IRBESARTAN
TABLET; ORAL
AVAPRO
SANOFI AVENTIS US
XX
XX
XX +

IRINOTECAN HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
CAMPTOSAR
40MG/2ML (20MG/ML)
+ PFIZER INC
100MG/5ML (20MG/ML)
+
IRINOTECAN HYDROCHLORIDE
ACCORD HLTHCARE
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
ACTAVIS TOTOWA
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
AKORN
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
APP PHARMS
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
BEDFORD LABS
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
BIONICHE PHARMA
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
DR REDDYS LABS LTD
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
EBEWE PHARMA
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
FRESENIUS KABI ONCOL 40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
HIKMA FARMACEUTICA
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
HOSPIRA
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)

001
002
001
002
001
002
001
002
001
002
002
003
001
002
001
002
001
002
001
002
001
002

21,
21,
27,
27,
16,
16,
27,
27,
24,
24,
13,
13,
15,
15,
12,
12,
27,
27,
20,
20,
27,
27,

2008
2008
2008
2008
2009
2009
2008
2008
2008
2008
2011
2011
2010
2010
2009
2009
2008
2008
2010
2010
2008
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 236 (of 424)

IRINOTECAN HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
IRINOTECAN HYDROCHLORIDE
+ HOSPIRA
500MG/25ML (20MG/ML)
JIANGSU HENGRUI MED
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
PLIVA LACHEMA
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
SUN PHARMA GLOBAL
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
TEVA PARENTERAL
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
500MG/25ML (20MG/ML)
WATSON LABS
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
X-GEN PHARMS
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
CAMPTOSAR
+ PFIZER INC
300MG/15ML (20MG/ML)

A078796
A090675
A090675
A078122
A078122
A078805
A078805
A077260
A077260
A090101
A077219
A077219
A090016
A090016

001
002
001
001
002
001
002
001
002
001
001
002
001
002

Feb
Dec
Dec
Oct
Oct
Apr
Apr
Feb
Feb
Nov
Feb
Feb
Jan
Jan

27,
16,
16,
31,
31,
21,
21,
27,
27,
26,
20,
20,
28,
28,

2008
2011
2011
2008
2008
2008
2008
2008
2008
2008
2008
2008
2009
2009

N020571 003

Aug 05, 2010

EQ 50MG IRON/ML

N040024 001

Feb 23, 1996

EQ 50MG IRON/ML

N017441 001

EQ 50MG IRON/ML

N017807 001

EQ 50MG BASE/2.5ML (EQ 20MG BASE/ML)

EQ 100MG BASE/5ML (EQ 20MG BASE/ML)
EQ 200MG BASE/10ML (EQ 20MG BASE/ML)

N021135 002
N021135 001
N021135 004

10MG

N011961 001

99.9%

N017624 001

99.9%
99.9%
99.9%
99.9%

A075225
A074097
A074416
A074502

INJECTABLE; INJECTION

ISONIAZID

XX + SANDOZ

100MG/ML

A040648 001

Jul 05, 2005

SYRUP; ORAL

ISONIAZID

XX + CAROLINA MEDCL

50MG/5ML

A088235 001

Nov 10, 1983

XX

IRON DEXTRAN
INJECTABLE; INJECTION
DEXFERRUM
BP
LUITPOLD
INFED
BP + WATSON LABS (UTAH)
PROFERDEX
BP
NEW RIVER

IRON SUCROSE
INJECTABLE; INTRAVENOUS
VENOFER
LUITPOLD
XX
XX +
XX

Mar 20, 2005

Nov 06, 2000
Feb 09, 2007

ISOCARBOXAZID
TABLET; ORAL

MARPLAN

XX + VALIDUS PHARMS INC

ISOFLURANE

AN
AN
AN
AN
AN

LIQUID; INHALATION
FORANE
+ BAXTER HLTHCARE CORP
ISOFLURANE
HALOCARBON PRODS
HOSPIRA
PIRAMAL CRITICAL
RHODIA

001
001
001
001

Oct
Jan
Sep
Jun

20,
25,
30,
27,

1999
1993
1994
1995

ISONIAZID

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 237 (of 424)

ISONIAZID
TABLET; ORAL
ISONIAZID
BARR
AA
AA
MIKART
AA
AA
AA + SANDOZ
AA +
WATSON LABS
AA
WEST WARD
AA
AA

100MG
300MG
100MG
300MG
100MG
300MG
300MG
100MG
300MG

A080936
A080937
A040090
A040090
N008678
N008678
A080521
A080212
A087425

001
002
001
002
002
003
001
001
001

Jun 26, 1997

Jun 26, 1997

ISONIAZID; PYRAZINAMIDE; RIFAMPIN

TABLET; ORAL

RIFATER

XX + SANOFI AVENTIS US

50MG;300MG;120MG

N050705 001

150MG;300MG

A061884 001

150MG;300MG

A065221 001

May 31, 1994

ISONIAZID; RIFAMPIN
CAPSULE; ORAL
RIFAMATE
AB + SANOFI AVENTIS US
RIFAMPIN AND ISONIAZID
WESTWARD
AB

Jul 29, 2005

ISOPROTERENOL HYDROCHLORIDE
INJECTABLE; INJECTION
ISOPROTERENOL HYDROCHLORIDE
INTL MEDICATION
AP
0.2MG/ML
ISUPREL
AP + HOSPIRA
0.2MG/ML

A083724 001
N010515 001

ISOSORBIDE DINITRATE
CAPSULE, EXTENDED RELEASE; ORAL

DILATRATE-SR

40MG
XX + SCHWARZ PHARMA
TABLET; ORAL
ISORDIL
VALEANT INTL
AB
AB
AB
AB +
ISOSORBIDE DINITRATE
PAR PHARM
AB
AB
AB
AB
SANDOZ
AB
AB
AB
WATSON LABS
AB
AB
WEST WARD
AB
AB
AB
AB
ISORDIL
XX + VALEANT INTL

N019790 001

Sep 02, 1988

5MG
10MG
20MG
30MG

N012093
N012093
N012093
N012093

007
002
006
005

Jul
Jul
Jul
Jul

29,
29,
29,
29,

1988
1988
1988
1988

5MG
10MG
20MG
30MG
5MG
10MG
20MG
5MG
10MG
5MG
10MG
20MG
30MG

A086923
A086925
A087537
A087946
A086221
A086223
A089367
A086034
A086032
A086067
A086066
A088088
A040591

001
001
001
001
001
001
001
001
001
001
001
001
001

Mar
Mar
Oct
Jan
Jan
Jan
Apr
Jan
Jan
Oct
Oct
Nov
Jan

12,
12,
02,
12,
07,
07,
07,
06,
07,
29,
29,
02,
10,

1987
1987
1987
1988
1988
1988
1988
1988
1988
1987
1987
1987
2007

40MG

N012093 001

Jul 29, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 238 (of 424)

ISOSORBIDE DINITRATE
TABLET; SUBLINGUAL
ISOSORBIDE DINITRATE
WATSON LABS
AB
AB +
WEST WARD
AB
AB

2.5MG
5MG
2.5MG
5MG

TABLET, EXTENDED RELEASE; ORAL

ISOSORBIDE DINITRATE
AB + CARACO
40MG
COREPHARMA
AB
40MG

A086033
A086031
A086054
A086055

001
001
001
001

Feb
Sep
Oct
Nov

26,
29,
29,
02,

1988
1987
1987
1987

A040009 001
A040723 001

Dec 30, 1998

Mar 17, 2008

10MG
20MG
20MG
20MG

A075037
A075037
A075147
A075361

Oct
Oct
Nov
Oct

10MG
20MG

N020215 002
N020215 001

Jun 30, 1993

Jun 30, 1993

A075306
A075306
A075166
A075522
A075041
A075155
A075155
A075155
A075395
A075395
A075395
A200270
A200495
A200495
A090598
A090598
A090598
A076813
A076813

Dec
Dec
Oct
Apr
Sep
Jan
Oct
Aug
Mar
Mar
Mar
Jun
Jun
Jun
Aug
Aug
Aug
Mar
Jan

ISOSORBIDE MONONITRATE
TABLET; ORAL
ISOSORBIDE MONONITRATE
ACTAVIS ELIZABETH
AB
AB
TEVA
AB
WEST WARD
AB
MONOKET
UCB INC
AB
AB +

TABLET, EXTENDED RELEASE; ORAL

ISOSORBIDE MONONITRATE
ACTAVIS ELIZABETH
AB
30MG
AB
60MG
BRIGHTSTONE
AB
60MG
DEXCEL LTD
AB
60MG
ELAN PHARM
AB
60MG
KREMERS URBAN PHARMS 30MG
AB
AB
60MG
AB +
120MG
NESHER PHARMS
AB
30MG
AB
60MG
AB
120MG
TORRENT PHARMS
AB
30MG
AB
60MG
AB
120MG
VINTAGE PHARMS
AB
30MG
AB
60MG
AB
120MG
WEST WARD
AB
30MG
AB
60MG

002
001
001
001

001
002
001
001
001
002
001
003
001
002
003
001
001
002
001
002
003
002
001

30,
30,
27,
05,

31,
31,
07,
17,
22,
13,
30,
04,
16,
16,
16,
03,
03,
03,
11,
11,
11,
30,
07,

1998
1998
1998
2000

1998
1998
1999
2000
1998
2000
1998
2000
2000
2000
2000
2011
2011
2011
2010
2010
2010
2006
2005

ISOSULFAN BLUE
INJECTABLE; INJECTION
ISOSULFAN BLUE
SYNERX
AP
LYMPHAZURIN
AP + COVIDIEN

Jul 20, 2010

1%

A090874 001

1%

N018310 001

10MG
20MG
40MG

A075945 001
A075945 002
A075945 003

Nov 08, 2002

Nov 08, 2002
Nov 08, 2002

10MG

A076356 001

Apr 11, 2003

ISOTRETINOIN

AB
AB
AB
AB

CAPSULE; ORAL
AMNESTEEM
MYLAN
+
+
CLARAVIS
BARR

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 239 (of 424)

ISOTRETINOIN
CAPSULE; ORAL
CLARAVIS
BARR
AB
AB
AB
SOTRET
RANBAXY
AB
AB
AB
AB

20MG
30MG
40MG

A076135 002
A076135 003
A076135 001

Apr 11, 2003

May 11, 2006
Apr 11, 2003

10MG
20MG
30MG
40MG

A076041
A076041
A076503
A076041

001
002
001
003

Dec
Dec
Jun
Dec

24,
24,
20,
24,

2002
2002
2003
2002

2.5MG
5MG
2.5MG
5MG

A077169
A077169
A077317
A077317

001
002
001
002

Apr
Apr
Jan
Jan

24,
24,
05,
05,

2006
2006
2006
2006

ISRADIPINE
CAPSULE; ORAL
ISRADIPINE
MIKAH PHARMA
AB
AB
WATSON LABS
AB
AB +

TABLET, EXTENDED RELEASE; ORAL

DYNACIRC CR
GLAXOSMITHKLINE LLC
5MG
XX
10MG
XX +

N020336 001
N020336 002

Jun 01, 1994

Jun 01, 1994

ITRACONAZOLE
CAPSULE; ORAL
ITRACONAZOLE
SANDOZ
AB
SPORANOX
AB + JANSSEN PHARMS

100MG

A076104 001

May 28, 2004

100MG

N020083 001

Sep 11, 1992

SOLUTION; ORAL

SPORANOX

XX + JANSSEN PHARMS

10MG/ML

N020657 001

Feb 21, 1997

TABLET; ORAL

ONMEL

XX + STIEFEL LABS INC

200MG

N022484 001

Apr 29, 2010

3MG

N050742 002

Oct 08, 1998

N022065 001
N022065 002

Oct 16, 2007

Oct 16, 2007

EQ 500MG BASE/2ML
EQ 1GM BASE/3ML

A065111 001
A065111 002

Dec 17, 2002

Dec 17, 2002

EQ 10MG BASE/ML
EQ 50MG BASE/ML

N016812 001
N016812 002

IVERMECTIN
TABLET; ORAL

STROMECTOL

XX + MERCK

IXABEPILONE
INJECTABLE; IV (INFUSION)

IXEMPRA KIT

XX + BRISTOL MYERS SQUIBB 15MG/VIAL

XX +
45MG/VIAL

KANAMYCIN SULFATE
INJECTABLE; INJECTION
KANAMYCIN SULFATE
APP PHARMS
XX
XX +

KETAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
KETALAR
AP + JHP PHARMS
AP +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 240 (of 424)

KETAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
KETALAR
AP + JHP PHARMS
KETAMINE HYDROCHLORIDE
BEDFORD
AP
AP
BIONICHE PHARMA
AP
AP
AP
HOSPIRA
AP
AP

EQ 100MG BASE/ML

N016812 003

EQ
EQ
EQ
EQ
EQ
EQ
EQ

A074524
A074524
A076092
A076092
A076092
A074549
A074549

50MG BASE/ML
100MG BASE/ML
10MG BASE/ML
50MG BASE/ML
100MG BASE/ML
50MG BASE/ML
100MG BASE/ML

001
002
001
002
003
001
002

Mar
Mar
Sep
Dec
Oct
Jun
Jun

22,
22,
30,
28,
25,
27,
27,

1996
1996
2008
2001
2002
1996
1996

KETOCONAZOLE
AEROSOL, FOAM; TOPICAL
EXTINA
AT + STIEFEL LABS INC
KETOCONAZOLE
PERRIGO ISRAEL
AT

2%

N021738 001

Jun 12, 2007

2%

A091550 001

Aug 25, 2011

CREAM; TOPICAL
KETOCONAZOLE
ALTANA
AB
AB + TEVA
KETOZOLE
TARO
AB

2%
2%

A076294 001
A075581 001

Apr 28, 2004

Apr 25, 2000

2%

A075638 001

Dec 18, 2002

2%

N021946 001

Jul 28, 2006

2%
2%

A076419 001
A076942 001

Jan 07, 2004

Apr 11, 2005

2%

N019927 001

Aug 31, 1990

200MG
200MG
200MG
200MG
200MG
200MG

A075912
A075314
A075597
A075362
A075319
A075273

Jan
Jun
Dec
Jun
Jun
Jun

10,
15,
23,
15,
15,
15,

2002
1999
1999
1999
1999
1999

200MG

N018533 001

50MG
75MG
50MG
75MG
50MG
75MG

A074014
A074014
A074035
A074035
A073516
A073517

Jan
Jan
Dec
Dec
Dec
Dec

29,
29,
31,
31,
22,
22,

1993
1993
1996
1996
1992
1992

25MG

A074014 001

Jan 29, 1993

A074879 001

Dec 10, 1997

GEL; TOPICAL

XOLEGEL

XX + AQUA PHARMS
SHAMPOO; TOPICAL
KETOCONAZOLE
PERRIGO NEW YORK
AB
TOLMAR
AB
NIZORAL
AB + JANSSEN PHARMS

AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
KETOCONAZOLE
APOTEX
MUTUAL PHARMA
MYLAN
PLIVA
TARO
TEVA
NIZORAL
+ ORTHO MCNEIL JANSSEN

001
001
001
001
001
001

KETOPROFEN
CAPSULE; ORAL
KETOPROFEN
HERITAGE PHARMS INC
AB
AB
MYLAN
AB
AB
TEVA
AB
AB +
KETOPROFEN
HERITAGE PHARMS INC
XX

CAPSULE, EXTENDED RELEASE; ORAL

KETOPROFEN
ELAN PHARM
AB
200MG

002
003
002
003
001
001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 241 (of 424)

KETOPROFEN
CAPSULE, EXTENDED RELEASE; ORAL
KETOPROFEN
MYLAN
AB
100MG
AB
150MG
AB +
200MG
WATSON LABS FLORIDA
AB
100MG
AB
150MG
AB
200MG

A075679
A075679
A075679
A075270
A075270
A075270

003
002
001
002
003
001

Feb
Feb
Feb
Mar
Mar
Mar

20,
20,
20,
24,
24,
24,

2002
2002
2002
1999
1999
1999

A075784
A075784
A075772
A075772
A075299
A075299
A075222
A075222
A075228
A075631
A075631
A074802
A074993
A074802
A074993
A078145
A078145
A078299
A078299
A076271
A076271
A078737
A078737
A077942
A077942
A077943

001
002
001
002
001
002
001
002
001
002
001
001
001
002
002
001
002
001
002
001
002
001
002
001
002
001

Jan
Jan
Jul
Jul
Nov
Nov
Apr
Apr
Apr
Jun
Jun
Jun
Jan
Jun
Jan
Jan
Jan
Jul
Jul
Oct
Oct
Oct
Oct
Mar
Mar
Mar

11,
11,
21,
21,
03,
03,
26,
26,
26,
29,
29,
05,
27,
05,
27,
14,
14,
16,
16,
06,
06,
06,
06,
27,
27,
27,

2002
2002
2004
2004
1999
1999
1999
1999
1999
2001
2001
1997
1999
1997
1999
2008
2008
2007
2007
2004
2004
2008
2008
2007
2007
2007

KETOROLAC TROMETHAMINE
INJECTABLE; INJECTION
KETOROLAC TROMETHAMINE
APP PHARMS
AP
AP
BAXTER HLTHCARE
AP
AP
BAXTER HLTHCARE CORP
AP
AP
AP + BEDFORD
AP +
AP +
CLARIS LIFESCIENCES
AP
AP
HOSPIRA
AP
AP
AP
AP
LUITPOLD
AP
AP
PFIZER
AP
AP
SANDOZ
AP
AP
SUN PHARMA GLOBAL
AP
AP
WOCKHARDT
AP
AP
AP

AT
AT
AT
AT
AT
AT
AT
AT
AT
XX
XX

15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
15MG/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
30MG/ML

SOLUTION/DROPS; OPHTHALMIC
ACULAR
+ ALLERGAN
0.5%
ACULAR LS
+ ALLERGAN
0.4%
KETOROLAC TROMETHAMINE
AKORN
0.4%
0.5%
ALCON PHARMS LTD
0.4%
0.5%
APOTEX INC
0.4%
0.5%
SUN PHARMA GLOBAL
0.5%
ACULAR PRESERVATIVE FREE
+ ALLERGAN
0.5%
ACUVAIL
+ ALLERGAN
0.45%

SPRAY, METERED; NASAL

SPRIX

XX + LUITPOLD

15.75MG/SPRAY

N019700 001

Nov 09, 1992

N021528 001

May 30, 2003

A078399
A078434
A078721
A076583
A077308
A076109
A090017

Nov
Nov
Nov
Nov
Nov
Nov
Nov

001
001
001
001
001
001
001

05,
05,
05,
05,
05,
05,
05,

2009
2009
2009
2009
2009
2009
2009

N020811 001

Nov 03, 1997

N022427 001

Jul 22, 2009

N022382 001

May 14, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 242 (of 424)

KETOROLAC TROMETHAMINE
TABLET; ORAL
KETOROLAC TROMETHAMINE
AB + MYLAN
PLIVA
AB
TEVA
AB

10MG
10MG
10MG

A074761 001
A075284 001
A074754 001

May 16, 1997

Jun 23, 1999
May 16, 1997

5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML

A075303
A076051
A075239
A075240
A075431
A075524

May
Jul
Nov
Nov
Nov
Nov

5MG/ML

A079134 001

Feb 03, 2010

A074787
A074787
A074787
A075113
A075113
A075113
A075133
A075133
A075133

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug

LABETALOL HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
LABETALOL HYDROCHLORIDE
BEDFORD
CLARIS LIFESCIENCES
+ HOSPIRA
+
TAYLOR
LABETALOL HYDROCLORIDE
SAGENT STRIDES

TABLET; ORAL
LABETALOL HYDROCHLORIDE
IVAX SUB TEVA PHARMS 100MG
AB
AB
200MG
AB
300MG
SANDOZ
AB
100MG
AB
200MG
AB
300MG
WATSON LABS
AB
100MG
AB
200MG
AB
300MG
TRANDATE
PROMETHEUS LABS
AB
100MG
AB +
200MG

001
001
001
001
001
001

001
002
003
001
002
003
001
002
003

28,
05,
29,
29,
29,
29,

03,
03,
03,
04,
04,
04,
03,
03,
03,

1999
2002
1999
1999
1999
1999

1998
1998
1998
1998
1998
1998
1998
1998
1998

N018716 001
N018716 002

May 24, 1985

Aug 01, 1984

LACOSAMIDE
SOLUTION; INTRAVENOUS

VIMPAT

XX + UCB INC

200MG/20ML (10MG/ML)

N022254 001

Oct 28, 2008

SOLUTION; ORAL

VIMPAT

XX + UCB INC

10MG/ML

N022255 001

Apr 20, 2010

TABLET; ORAL
VIMPAT
UCB INC
XX
XX
XX
XX +

50MG
100MG
150MG
200MG

N022253
N022253
N022253
N022253

Oct
Oct
Oct
Oct

10GM/PACKET
20GM/PACKET

A074712 001
A074712 002

Dec 10, 1997

Dec 10, 1997

10GM/15ML

A071054 001

Jul 26, 1988

10GM/15ML

A070288 001

Aug 15, 1988

10GM/15ML

A078430 001

Nov 28, 2007

001
002
003
004

28,
28,
28,
28,

2008
2008
2008
2008

LACTULOSE
FOR SOLUTION; ORAL

LACTULOSE

XX + INALCO
XX +
SOLUTION; ORAL
CONSTILAC
ALRA
AA
CONSTULOSE
AA + ACTAVIS MID ATLANTIC
LACTULOSE
ANI PHARMS
AA

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 243 (of 424)

LACTULOSE

AA
AA
AA
AA
AA
AA
AA

AA
AA
AA
AA
AA
AA

SOLUTION; ORAL
LACTULOSE
HI TECH PHARMA
MORTON GROVE
NOVEX
PHARM ASSOC
ROXANE
VINTAGE PHARMS
VISTAPHARM
SOLUTION; ORAL, RECTAL
CHOLAC
ALRA
ENULOSE
+ ACTAVIS MID ATLANTIC
GENERLAC
MORTON GROVE PHARMS
LACTULOSE
ANI PHARMS
HI TECH PHARMA
NOVEX

001
001
001
001
001
001
001

Jul
Nov
Feb
Jul
May
Jul
Sep

03,
14,
21,
30,
29,
26,
30,

1995
1996
2002
1996
1992
2001
1992

10GM/15ML
10GM/15ML
10GM/15ML
10GM/15ML
10GM/15ML
10GM/15ML
10GM/15ML

A074076
A074602
A075911
A074623
A073591
A075993
A074138

10GM/15ML

A071331 001

Jul 26, 1988

10GM/15ML

A071548 001

Aug 15, 1988

10GM/15ML

A074603 001

Oct 31, 1996

10GM/15ML
10GM/15ML
10GM/15ML

A090426 001
A074077 001
A076645 001

Nov 21, 2008

Jul 03, 1995
Jul 28, 2003

10MG/ML

N020596 001

Nov 17, 1995

5MG/ML

N021004 001

Dec 08, 1998

150MG
300MG

N020564 001
N020564 003

Nov 17, 1995

Jun 24, 2002

150MG
300MG
150MG
300MG

A091606
A091606
A202032
A202032

Dec
Dec
Nov
Nov

100MG

N021003 001

Dec 08, 1998

N020857 001

Sep 26, 1997

A079081 001

May 25, 2011

25MG
100MG
150MG
200MG

N020241
N020241
N020241
N020241

005
001
002
003

Dec
Dec
Dec
Dec

27,
27,
27,
27,

1994
1994
1994
1994

25MG
100MG
150MG
200MG
25MG

A078669
A078669
A078669
A078669
A090607

001
002
003
004
001

Apr
Apr
Apr
Apr
Jan

08,
08,
08,
08,
13,

2011
2011
2011
2011
2011

LAMIVUDINE
SOLUTION; ORAL

EPIVIR

XX + VIIV HLTHCARE
EPIVIR-HBV
XX + GLAXOSMITHKLINE
TABLET; ORAL
EPIVIR
VIIV HLTHCARE
AB
AB +
LAMIVUDINE
APOTEX
AB
AB
AUROBINDO PHARMA LTD
AB
AB
EPIVIR-HBV
XX + GLAXOSMITHKLINE

001
002
001
002

02,
02,
17,
17,

2011
2011
2011
2011

LAMIVUDINE; ZIDOVUDINE
TABLET; ORAL
COMBIVIR
AB + VIIV HLTHCARE
150MG;300MG
LAMIVUDINE AND ZIDOVUDINE
TEVA PHARMS
AB
150MG;300MG

LAMOTRIGINE
TABLET; ORAL
LAMICTAL
AB + GLAXOSMITHKLINE
AB
AB
AB
LAMOTRIGINE
ACTAVIS TOTOWA
AB
AB
AB
AB
ALEMBIC PHARMS LTD
AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 244 (of 424)

LAMOTRIGINE
TABLET; ORAL
LAMOTRIGINE
ALEMBIC PHARMS LTD
AB
AB
AB
APOTEX INC
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
CADISTA PHARMS
AB
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
AB
HIKMA PHARMS
AB
AB
AB
AB
LUPIN LTD
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
TARO PHARM INDS
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

100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG

A090607
A090607
A090607
A078625
A078625
A078625
A078625
A078956
A078956
A078956
A078956
A079132
A079132
A079132
A079132
A076708
A076708
A076708
A076708
A078134
A078134
A078134
A078134
A078691
A078691
A078691
A078691
A077420
A077420
A077420
A077420
A078645
A078645
A078645
A078645
A078525
A078525
A078525
A078525
A076388
A076388
A076388
A076388
A078947
A078947
A078947
A078947
A090170
A090170
A090170
A090170
A078310
A078310
A078310
A078310
A077783
A077783

002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002

Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Aug
Aug
Aug
Aug
Jan
Jan
Jan
Jan
Oct
Oct
Oct
Oct
Feb
Feb
Feb
Feb
Nov
Nov

13,
13,
13,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
19,
19,
19,
19,
01,
01,
01,
01,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
30,
30,
30,
30,
27,
27,
27,
27,
06,
06,
06,
06,
04,
04,
04,
04,
01,
01,

2011
2011
2011
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2011
2011
2011
2011
2010
2010
2010
2010
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2006
2006
2006
2006
2009
2009
2009
2009
2011
2011
2011
2011
2009
2009
2009
2009
2010
2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 245 (of 424)

LAMOTRIGINE
TABLET; ORAL
LAMOTRIGINE
WATSON LABS
AB
AB
ZYDUS PHARMS USA
AB
AB
AB
AB
LAMOTRIGINE
ZYDUS PHARMS USA
XX
XX

01,
01,
27,
27,
27,
27,

2010
2010
2009
2009
2009
2009

A077783
A077783
A077633
A077633
A077633
A077633

50MG
250MG

A077633 002
A077633 006

Jan 27, 2009

Jan 27, 2009

2MG
5MG
25MG

N020764 004
N020764 001
N020764 002

Sep 08, 2000

Aug 24, 1998
Aug 24, 1998

5MG
25MG
5MG
25MG
5MG
25MG
5MG
25MG
5MG
25MG
5MG
25MG
5MG
25MG
2MG
5MG
25MG
5MG
25MG

A090401
A090401
A076701
A076701
A079099
A079099
A200220
A200220
A076630
A076630
A079204
A079204
A076420
A076420
A076928
A076928
A076928
A078009
A078009

002
003
001
002
001
002
001
002
001
002
001
002
001
002
001
002
003
002
003

Nov
Nov
Jan
Jan
Feb
Feb
Feb
Feb
Jan
Jan
Feb
Feb
Jun
Jun
Jan
Jan
Jan
Jan
Jan

04,
04,
22,
22,
19,
19,
28,
28,
22,
22,
04,
04,
21,
21,
22,
22,
22,
22,
22,

2009
2009
2009
2009
2009
2009
2011
2011
2009
2009
2009
2009
2006
2006
2009
2009
2009
2009
2009

TABLET, EXTENDED RELEASE; ORAL

LAMICTAL XR
SMITHKLINE BEECHAM
25MG
XX
50MG
XX +
100MG
XX
200MG
XX
250MG
XX
300MG
XX

N022115
N022115
N022115
N022115
N022115
N022115

001
002
003
004
006
005

May
May
May
May
Jun
Apr

29,
29,
29,
29,
21,
14,

2009
2009
2009
2009
2011
2010

TABLET, ORALLY DISINTEGRATING; ORAL

LAMICTAL ODT
SMITHKLINE BEECHAM
25MG
XX
50MG
XX +
100MG
XX
200MG
XX

N022251
N022251
N022251
N022251

001
002
003
004

May
May
May
May

08,
08,
08,
08,

2009
2009
2009
2009

TABLET, CHEWABLE; ORAL

LAMICTAL CD
GLAXOSMITHKLINE
AB
AB
AB +
LAMOTRIGINE
AUROBINDO PHARMA
AB
AB
DR REDDYS LABS LTD
AB
AB
GLENMARK GENERICS
AB
AB
JUBILANT LIFE
AB
AB
MYLAN
AB
AB
TARO
AB
AB
TEVA
AB
AB
WATSON LABS
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB

003
004
001
003
004
005

Nov
Nov
Jan
Jan
Jan
Jan

150MG
200MG
25MG
100MG
150MG
200MG

LANREOTIDE ACETATE
INJECTABLE; SUBCUTANEOUS

SOMATULINE DEPOT

XX + IPSEN PHARMS
XX +
XX +

EQ 60MG BASE
EQ 90MG BASE
EQ 120MG BASE

N022074 001
N022074 002
N022074 003

Aug 30, 2007

Aug 30, 2007
Aug 30, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 246 (of 424)

LANSOPRAZOLE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

CAPSULE, DELAYED REL PELLETS; ORAL

LANSOPRAZOLE
DR REDDYS LABS LTD
15MG
30MG
MATRIX LABS LTD
15MG
30MG
SANDOZ
15MG
30MG
TEVA PHARMS
15MG
30MG
PREVACID
TAKEDA PHARMS NA
15MG
+
30MG

A091269
A091269
A090763
A090763
A090331
A090331
A077255
A077255

001
002
001
002
001
002
001
002

Oct
Oct
Nov
Nov
Apr
Apr
Nov
Nov

15,
15,
10,
10,
23,
23,
10,
10,

2010
2010
2009
2009
2010
2010
2009
2009

N020406 001
N020406 002

May 10, 1995

May 10, 1995

A078730 001
A078730 002

Oct 15, 2010

Oct 15, 2010

N021428 001
N021428 002

Aug 30, 2002

Aug 30, 2002

EQ 500MG BASE
EQ 750MG BASE
EQ 1GM BASE

N021468 002
N021468 003
N021468 004

Oct 26, 2004

Nov 23, 2005
Nov 23, 2005

EQ 250MG BASE

N022059 001

Mar 13, 2007

A091449
A077697
A201006
A200925
A201786
A090887

Mar
Mar
Mar
Mar
Mar
Jul

TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING; ORAL

LANSOPRAZOLE
TEVA PHARMS
15MG
AB
30MG
AB
PREVACID
TAKEDA PHARMS NA
AB
15MG
AB +
30MG

LANTHANUM CARBONATE
TABLET, CHEWABLE; ORAL
FOSRENOL
SHIRE
XX
XX
XX +

LAPATINIB DITOSYLATE
TABLET; ORAL

TYKERB

XX + SMITHKLINE BEECHAM

LATANOPROST

AT
AT
AT
AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
LATANOPROST
ALCON RES
0.005%
APOTEX
0.005%
BAUSCH AND LOMB
0.005%
LUITPOLD
0.005%
MYLAN
0.005%
PADDOCK LLC
0.005%
XALATAN
+ PHARMACIA AND UPJOHN 0.005%

001
001
001
001
001
001

22,
22,
22,
22,
22,
19,

2011
2011
2011
2011
2011
2011

N020597 001

Jun 05, 1996

10MG
20MG

N020905 001
N020905 002

Sep 10, 1998

Sep 10, 1998

10MG
20MG
10MG
20MG
10MG
20MG
10MG

A091369
A091369
A077090
A077090
A077083
A077083
A077086

Nov
Nov
Sep
Sep
Sep
Sep
Sep

LEFLUNOMIDE
TABLET; ORAL
ARAVA
SANOFI AVENTIS US
AB
AB +
LEFLUNOMIDE
ALEMBIC PHARMS LTD
AB
AB
APOTEX INC
AB
AB
BARR
AB
AB
HERITAGE PHARMS INC
AB

001
002
001
002
001
002
001

21,
21,
13,
13,
13,
13,
13,

2011
2011
2005
2005
2005
2005
2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 247 (of 424)

LEFLUNOMIDE
TABLET; ORAL
LEFLUNOMIDE
HERITAGE PHARMS INC
AB
SANDOZ
AB
AB
TEVA PHARMS
AB
AB
ARAVA
XX + SANOFI AVENTIS US

002
001
002
001
002

Sep
Sep
Sep
Sep
Sep

13,
13,
13,
13,
13,

2005
2005
2005
2005
2005

20MG
10MG
20MG
10MG
20MG

A077086
A077087
A077087
A077084
A077084

100MG

N020905 003

Sep 10, 1998

2.5MG
5MG
10MG
15MG
25MG

N021880
N021880
N021880
N021880
N021880

Dec
Dec
Dec
Jun
Jun

50MG/VIAL

N020807 001

Mar 06, 1998

2.5MG

N020726 001

Jul 25, 1997

2.5MG
2.5MG
2.5MG
2.5MG
2.5MG
2.5MG
2.5MG
2.5MG
2.5MG
2.5MG
2.5MG
2.5MG
2.5MG

A090934
A090292
A091191
A090789
A090491
A091638
A201804
A091098
A078190
A200161
A090838
A091466
A090289

001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jul
Jun
Jun
Jun
Jun
Jun
Jun
Dec
Jun
Jun
Jun
Jun

03,
13,
03,
03,
03,
03,
03,
03,
24,
03,
03,
03,
03,

2011
2011
2011
2011
2011
2011
2011
2011
2008
2011
2011
2011
2011

A089384
A089717
A081278
A081277
A040174

001
001
001
001
001

Sep
Mar
Sep
Sep
Jun

14,
28,
28,
28,
12,

1987
1988
1993
1993
1997

A040258
A040056
A040335
A040338

001
001
001
001

Feb
May
Apr
Jan

26,
23,
20,
31,

1999
1995
2000
2001

LENALIDOMIDE
CAPSULE; ORAL
REVLIMID
CELGENE
XX
XX
XX
XX +
XX +

005
001
002
003
004

21,
27,
27,
29,
29,

2011
2005
2005
2006
2006

LEPIRUDIN RECOMBINANT
INJECTABLE; INJECTION

REFLUDAN

XX + BAYER HLTHCARE

LETROZOLE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
FEMARA
+ NOVARTIS PHARMS
LETROZOLE
ACCORD HLTHCARE
ACTAVIS TOTOWA
DR REDDYS LABS LTD
ENDO PHARMS
FRESENIUS KABI ONCOL
IMPAX LABS
INDICUS PHARMA
KUDCO IRELAND
MYLAN
NATCO PHARMA LTD
ROXANE
SUN PHARM INDS LTD
TEVA PHARMS

LEUCOVORIN CALCIUM
INJECTABLE; INJECTION
LEUCOVORIN CALCIUM
AP + BEDFORD
EQ 50MG BASE/VIAL
AP +
EQ 100MG BASE/VIAL
TEVA PARENTERAL
AP
EQ 50MG BASE/VIAL
AP
EQ 100MG BASE/VIAL
AP
EQ 350MG BASE/VIAL
LEUCOVORIN CALCIUM PRESERVATIVE FREE
APP PHARMS
AP
EQ 200MG BASE/VIAL
AP + BEDFORD
EQ 200MG BASE/VIAL
AP +
EQ 350MG BASE/VIAL
LUITPOLD
AP
EQ 50MG BASE/VIAL
LEUCOVORIN CALCIUM PRESERVATIVE FREE
EQ 500MG BASE/VIAL
XX + APP PHARMS
EQ 10MG BASE/ML
XX + BEDFORD

A040286 001
A040347 001

Feb 26, 1999

Apr 25, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 248 (of 424)

LEUCOVORIN CALCIUM
TABLET; ORAL
LEUCOVORIN CALCIUM
BARR
AB
AB
ROXANE
AB
AB
AB +
LEUCOVORIN CALCIUM
ROXANE
XX

EQ
EQ
EQ
EQ
EQ

5MG BASE
25MG BASE
5MG BASE
15MG BASE
25MG BASE

A071198
A071199
A072733
A072735
A072736

001
001
001
001
001

Sep
Sep
Feb
Feb
Feb

24,
24,
22,
22,
22,

1987
1987
1993
1993
1993

EQ 10MG BASE

A072734 001

Feb 22, 1993

1MG/0.2ML
1MG/0.2ML
1MG/0.2ML

A074728 001
A078885 001
A075471 001

Aug 04, 1998

Mar 09, 2009
Oct 25, 2000

22.5MG/VIAL
30MG/VIAL
45MG/VIAL
3.75MG/VIAL
7.5MG/VIAL
11.25MG/VIAL

N020517
N020517
N020517
N020011
N019732
N020708

001
002
003
001
001
001

Dec
May
Jun
Oct
Jan
Mar

22,
30,
17,
22,
26,
07,

1995
1997
2011
1990
1989
1997

7.5MG/VIAL
11.25MG/VIAL
11.25MG/VIAL
15MG/VIAL
30MG/VIAL

N020263
N020263
N020263
N020263
N020263

002
005
007
006
008

Apr
Jan
Aug
Jan
Aug

16,
21,
15,
21,
15,

1993
1994
2011
1994
2011

7.5MG/VIAL
22.5MG/VIAL
30MG/VIAL
45MG/VIAL

N021343
N021379
N021488
N021731

001
001
001
001

Jan
Jul
Feb
Dec

23,
24,
13,
14,

2002
2002
2003
2004

0.25% BASE
0.0103% BASE
0.021% BASE
0.042% BASE

A078309
A077756
A077756
A077756

001
003
001
002

Mar
Apr
Apr
Apr

20,
09,
09,
09,

2009
2008
2008
2008

0.0103% BASE
0.021% BASE
0.042% BASE
0.25% BASE

N020837
N020837
N020837
N020837

003
001
002
004

Jan
Mar
Mar
Jul

30,
25,
25,
18,

2002
1999
1999
2003

LEUPROLIDE ACETATE

AP
AP
AP
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX

XX
XX
XX
XX

INJECTABLE; INJECTION
LEUPROLIDE ACETATE
+ SANDOZ
SUN PHARMA GLOBAL
TEVA PARENTERAL
LUPRON DEPOT
+ ABBOTT ENDOCRINE
+
+ ABBOTT LABS
+
+
LUPRON DEPOT-PED
+ ABBOTT ENDOCRINE
+
+
+
+
INJECTABLE; SUBCUTANEOUS

ELIGARD

+ TOLMAR THERAP
+
+
+

LEVALBUTEROL HYDROCHLORIDE

AN
AN
AN
AN
AN
AN
AN
AN

SOLUTION; INHALATION
LEVALBUTEROL HYDROCHLORIDE
DEY
EQ
WATSON LABS INC
EQ
EQ
EQ
XOPENEX
+ SUNOVION
EQ
+
EQ
+
EQ
+
EQ

LEVALBUTEROL TARTRATE
AEROSOL, METERED; INHALATION

XOPENEX HFA

EQ 0.045MG BASE/INH
XX + SUNOVION

N021730 001

Mar 11, 2005

N021872 001

Jul 31, 2006

LEVETIRACETAM
INJECTABLE; IV (INFUSION)
KEPPRA
AP + UCB INC
500MG/5ML (100MG/ML)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 249 (of 424)

LEVETIRACETAM

AP
AP
AP
AP
XX
XX
XX

AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA

INJECTABLE; IV (INFUSION)
LEVETIRACETAM
HIKMA FARMACEUTICA
INNOPHARMA LLC
NEXUS PHARMS
SUN PHARM INDS LTD
LEVETIRACETAM IN SODIUM
+ HQ SPECIALITY PHARMA
+
+
SOLUTION; ORAL
KEPPRA
+ UCB INC
LEVETIRACETAM
ACTAVIS MID ATLANTIC
AMNEAL PHARMS
APOTEX
AUROBINDO PHARM
CYPRESS PHARM
LUPIN LTD
ROXANE
SILARX
TARO
TOLMAR
TRIS PHARMA INC
WOCKHARDT

TABLET; ORAL
KEPPRA
UCB INC
AB
AB
AB
AB +
LEVETIRACETAM
ACCORD HLTHCARE
AB
AB
AB
AB
AJANTA PHARMA
AB
AB
AB
AB
APOTEX INC
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
BIOKEY
AB
BOCA PHARMA
AB
AB
AB
BRECKENRIDGE PHARM
AB
AB
AB
AB
COBALT LABS INC
AB
AB

001
001
001
001

Oct
Aug
May
Jun

13,
05,
26,
16,

2011
2011
2010
2010

500MG/5ML(100MG/ML)
500MG/5ML (100MG/ML)
500MG/5ML (100MG/ML)
500MG/5ML (100MG/ML)
CHLORIDE
500MG/100ML (5MG/ML)
1000MG/100ML (10MG/ML)
1500MG/100ML (15MG/ML)

A090981
A091485
A090813
A090754

N202543 001
N202543 002
N202543 003

Nov 09, 2011

Nov 09, 2011
Nov 09, 2011

100MG/ML

N021505 001

Jul 15, 2003

100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML

A078976
A090992
A090187
A079063
A079120
A090893
A078582
A090263
A078774
A079107
A090461
A090028

001
001
001
001
001
001
001
001
001
001
001
001

Jan
Oct
Aug
Jan
Jan
Oct
Jan
Apr
Feb
Jan
Sep
Mar

15,
27,
05,
15,
16,
17,
15,
03,
10,
15,
30,
03,

2009
2009
2011
2009
2009
2011
2009
2009
2009
2009
2010
2010

250MG
500MG
750MG
1GM

N021035
N021035
N021035
N021035

001
002
003
004

Nov
Nov
Nov
Jan

30,
30,
30,
06,

1999
1999
1999
2006

250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
500MG
250MG
500MG
750MG
250MG
500MG
750MG
1GM
250MG
500MG

A090843
A090843
A090843
A090843
A201293
A201293
A201293
A201293
A078869
A078869
A078869
A078869
A078993
A078993
A078993
A078993
A090906
A077319
A077319
A077319
A090511
A090511
A090511
A090511
A077384
A077384

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
001
002
003
001
002
003
004
001
002

Feb
Feb
Feb
Feb
Jun
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Jan
Jan
Jan
Jan
Nov
Mar
Mar
Mar
Aug
Aug
Aug
Aug
Jan
Jan

14,
14,
14,
14,
14,
14,
14,
14,
13,
13,
13,
13,
15,
15,
15,
15,
05,
20,
20,
20,
18,
18,
18,
18,
15,
15,

2011
2011
2011
2011
2011
2011
2011
2011
2009
2009
2009
2009
2009
2009
2009
2009
2010
2009
2009
2009
2011
2011
2011
2011
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 250 (of 424)

LEVETIRACETAM
TABLET; ORAL
LEVETIRACETAM
COBALT LABS INC
AB
DR REDDYS LABS LTD
AB
AB
AB
AB
HETERO DRUGS LTD
AB
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
LUPIN
AB
AB
AB
AB
METHAPHARM
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
ORCHID HLTHCARE
AB
AB
AB
AB
ROXANE
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
SOLCO HLTHCARE
AB
AB
AB
AB
TARO
AB
AB
AB
AB
TEVA PHARMS
AB
AB
AB
AB
TORRENT PHARMS
AB
AB
AB
AB
VINTAGE PHARMS
AB
AB
AB
AB
WATSON LABS
AB

750MG
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
250MG
500MG
750MG
1GM
1GM

A077384
A076920
A076920
A076920
A078904
A090515
A090515
A090515
A090515
A078234
A078234
A078234
A078154
A078154
A078154
A090025
A090767
A090767
A090767
A090767
A076919
A076919
A076919
A090261
A078526
A078526
A078526
A090484
A078042
A078042
A078042
A078042
A077324
A077324
A077324
A077324
A078106
A078106
A078106
A078106
A078960
A078960
A078960
A078960
A078101
A078101
A078101
A078101
A078858
A078858
A078858
A078858
A091491
A091491
A091491
A091491
A078797

003
001
002
003
001
001
002
003
004
001
002
003
001
002
003
001
001
002
003
004
001
002
003
001
001
002
003
001
001
002
003
004
001
002
003
004
001
002
003
004
004
003
002
001
001
002
003
004
001
002
003
004
001
002
003
004
001

Jan
Jan
Jan
Jan
Jan
Oct
Oct
Oct
Oct
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jul
Jul
Jul
Jul
Nov
Nov
Nov
Dec
Jan
Jan
Jan
Aug
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Dec
Dec
Dec
Dec
Jan

15,
15,
15,
15,
15,
08,
08,
08,
08,
15,
15,
15,
15,
15,
15,
15,
28,
28,
28,
28,
04,
04,
04,
08,
15,
15,
15,
05,
15,
15,
15,
15,
15,
15,
15,
15,
10,
10,
10,
10,
01,
01,
01,
01,
15,
15,
15,
15,
15,
15,
15,
15,
14,
14,
14,
14,
15,

2009
2009
2009
2009
2009
2010
2010
2010
2010
2009
2009
2009
2009
2009
2009
2009
2010
2010
2010
2010
2008
2008
2008
2009
2009
2009
2009
2010
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2010
2010
2010
2010
2009
2009
2009
2009
2009
2009
2009
2009
2010
2010
2010
2010
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 251 (of 424)

LEVETIRACETAM
TABLET; ORAL
LEVETIRACETAM
WOCKHARDT
AB
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB
TABLET, EXTENDED RELEASE;
KEPPRA XR
UCB INC
AB
AB +
LEVETIRACETAM
ACTAVIS ELIZABETH
AB
AB
ANCHEN PHARMS
AB
AB
APOTEX INC
AB
AB
LUPIN LTD
AB
AB
MUTUAL PHARM CO INC
AB
AB
MYLAN PHARMS INC
AB
AB
PAR PHARM
AB
AB
TEVA PHARMS
AB
AB
WATSON LABS FLORIDA
AB
AB

250MG
500MG
750MG
1GM
250MG
1GM

A079042
A079042
A079042
A079042
A078918
A078918

001
002
003
004
001
002

Jan
Jan
Jan
Jan
Apr
Apr

15,
15,
15,
15,
29,
29,

2009
2009
2009
2009
2009
2009

ORAL
500MG
750MG

N022285 001
N022285 002

Sep 12, 2008

Feb 12, 2009

500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG

A091557
A091557
A091360
A091360
A091261
A091261
A091399
A091399
A091285
A091285
A200475
A200475
A091291
A091291
A091430
A091430
A091093
A091093

Sep
Sep
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Sep
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Sep

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

12,
12,
04,
04,
12,
12,
12,
12,
12,
12,
19,
19,
12,
12,
12,
12,
12,
12,

2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011

LEVOBUNOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
AKBETA
AKORN
AT
0.25%
AT
0.5%
BETAGAN
AT + ALLERGAN
0.25%
AT +
0.5%
LEVOBUNOLOL HYDROCHLORIDE
BAUSCH AND LOMB
AT
0.25%
AT
0.5%
FALCON PHARMS
AT
0.25%
AT
0.5%
NOVEX
AT
0.25%
AT
0.5%

A074779 001
A074780 001

Oct 29, 1996

Oct 29, 1996

N019814 001
N019219 002

Jun 28, 1989

Dec 19, 1985

A074307
A074326
A074851
A074850
A075473
A075475

Mar
Mar
Oct
Oct
Aug
Aug

001
001
001
001
001
001

04,
04,
28,
28,
03,
03,

1994
1994
1996
1996
2000
2000

LEVOCARNITINE

AP
AP
AP
AP

INJECTABLE; INJECTION
CARNITOR
+ SIGMA TAU
LEVOCARNITINE
BEDFORD
LUITPOLD
TEVA PARENTERAL

SOLUTION; ORAL
CARNITOR
AA + SIGMA TAU

200MG/ML

N020182 001

Dec 16, 1992

200MG/ML
200MG/ML
200MG/ML

A075567 001
A075861 001
A075881 001

Mar 29, 2001

Jun 22, 2001
Mar 29, 2001

1GM/10ML

N019257 001

Apr 10, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 252 (of 424)

LEVOCARNITINE
SOLUTION; ORAL
CARNITOR SF
SIGMA TAU
AA
LEVOCARNITINE
HI TECH PHARMA
AA
LYNE
AA
TABLET; ORAL
CARNITOR
AB + SIGMA TAU
LEVOCARNITINE
COREPHARMA
AB

1GM/10ML

N019257 002

Mar 28, 2007

1GM/10ML
1GM/10ML

A077399 001
A076851 001

Oct 25, 2007

Aug 10, 2004

330MG

N018948 001

Dec 27, 1985

330MG

A076858 001

Sep 20, 2004

A091263 001

Nov 07, 2011

N022157 001

Jan 28, 2008

A090392
A090385
A090229
A090199

Feb
Feb
Nov
Aug

LEVOCETIRIZINE DIHYDROCHLORIDE
SOLUTION; ORAL
LEVOCETIRIZINE DIHYDROCHLORIDE
SYNTHON PHARMS
AA
2.5MG/5ML
XYZAL
AA + UCB INC
2.5MG/5ML

AB
AB
AB
AB
AB

TABLET; ORAL
LEVOCETIRIZINE DIHYDROCHLORIDE
DR REDDYS LABS LTD
5MG
GLENMARK GENERICS
5MG
SYNTHON PHARMS
5MG
TEVA PHARMS
5MG
XYZAL
+ UCB INC
5MG

001
001
001
001

24,
24,
26,
22,

2011
2011
2010
2011

N022064 001

May 25, 2007

N020635 001
N020635 004

Dec 20, 1996

Dec 20, 1996

N020635 002
N020635 003
N020635 005

Dec 20, 1996

Dec 20, 1996
Dec 20, 1996

A091644
A091644
A200560
A200560

001
002
001
002

Jun
Jun
Jun
Jun

20,
20,
20,
20,

2011
2011
2011
2011

A090343
A090343
A090343
A091375
A091375
A091375

001
002
003
001
002
003

Jul
Jul
Jul
Sep
Sep
Sep

07,
07,
07,
16,
16,
16,

2011
2011
2011
2011
2011
2011

LEVOFLOXACIN

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
LEVAQUIN
+ JANSSEN PHARMS
EQ 500MG/20ML (EQ 25MG/ML)
+
EQ 750MG/30ML (EQ 25MG/ML)
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
+ JANSSEN PHARMS
EQ 250MG/50ML (EQ 5MG/ML)
+
EQ 500MG/100ML (EQ 5MG/ML)
+
EQ 750MG/150ML (EQ 5MG/ML)
LEVOFLOXACIN
AKORN
EQ 500MG/20ML (EQ 25MG/ML)
EQ 750MG/30ML (EQ 25MG/ML)
SAGENT PHARMS
EQ 500MG/20ML (EQ 25MG/ML)
EQ 750MG/30ML (EQ 25MG/ML)
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ACS DOBFAR INFO SA
EQ 250MG/50ML (EQ 5MG/ML)
EQ 500MG/100ML (EQ 5MG/ML)
EQ 750MG/150ML (EQ 5MG/ML)
HIKMA FARMACEUTICA
EQ 250MG/50ML (EQ 5MG/ML)
EQ 500MG/100ML (EQ5MG/ML)
EQ 750MG/150ML (EQ 5MG/ML)

SOLUTION; ORAL
LEVAQUIN
AA + JANSSEN PHARMS
LEVOFLOXACIN
HI TECH PHARMA
AA

250MG/10ML

N021721 001

Oct 21, 2004

250MG/10ML

A091678 001

Jun 20, 2011

A090268 001
A078282 001
A076826 001

Dec 20, 2010

Dec 20, 2010
Feb 10, 2011

SOLUTION/DROPS; OPHTHALMIC
LEVOFLOXACIN
AKORN
AT
0.5%
APOTEX
AT
0.5%
HI TECH PHARMA
AT
0.5%

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 253 (of 424)

LEVOFLOXACIN
SOLUTION/DROPS; OPHTHALMIC
LEVOFLOXACIN
NEXUS PHARMS
AT
0.5%
QUIXIN
AT + SANTEN
0.5%
IQUIX
1.5%
XX + SANTEN

A077700 001

Dec 20, 2010

N021199 001

Aug 18, 2000

N021571 001

Mar 01, 2004

250MG
500MG
750MG

N020634 001
N020634 002
N020634 003

Dec 20, 1996

Dec 20, 1996
Sep 08, 2000

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

A090787
A090787
A090787
A201043
A201043
A201043
A076710
A076710
A076710
A200250
A200250
A200250
A078424
A078424
A078424
A076276
A076276
A077097
A077438
A077438
A077438
A076361
A076361
A076361
A090722
A090722
A090722
A090367
A090367
A090367

Sep
Sep
Sep
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

POWDER; IV (INFUSION)

FUSILEV

XX + SPECTRUM PHARMS

EQ 50MG BASE/VIAL

N020140 001

Mar 07, 2008

SOLUTION; IV (INFUSION)

FUSILEV

XX + SPECTRUM PHARMS
XX +

EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

N020140 002
N020140 003

Apr 29, 2011

Apr 29, 2011

TABLET; ORAL
LEVAQUIN
JANSSEN PHARMS
AB
AB
AB +
LEVOFLOXACIN
APOTEX INC
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
DR REDDYS LABS INC
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
LUPIN
AB
AB
AB
MYLAN
AB
AB
AB
SANDOZ
AB
AB
AB
TEVA
AB
AB
AB
TORRENT PHARMS
AB
AB
AB
WOCKHARDT
AB
AB
AB

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
001
001
002
003
001
002
003
001
002
003
001
002
003

29,
29,
29,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011

LEVOLEUCOVORIN CALCIUM

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

INJECTABLE; INJECTION
ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
NOVOCOL
AP
0.05MG/ML;2%
SCANDONEST L
DEPROCO
AP
0.05MG/ML;2%

A084697 001
A088388 001

Oct 10, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 254 (of 424)

LEVONORGESTREL
INTRAUTERINE DEVICE; INTRAUTERINE

MIRENA

52MG
XX + BAYER HLTHCARE
TABLET; ORAL
LEVONORGESTREL
PERRIGO R AND D
AB
AB + WATSON LABS
AB
PLAN B
AB + TEVA WOMENS
PLAN B ONE-STEP
XX + DURAMED

N021225 001

Dec 06, 2000

0.75MG
0.75MG
0.75MG

A090740 001
A078665 001
A078666 001

Dec 30, 2010

Aug 28, 2009
Jun 24, 2009

0.75MG

N021045 002

Aug 24, 2006

1.5MG

N021998 001

Jul 10, 2009

2MG

A074278 001

Mar 31, 2000

LEVORPHANOL TARTRATE
TABLET; ORAL
LEVORPHANOL TARTRATE
ROXANE
XX

LEVOTHYROXINE SODIUM**

**Refer to Preface Section 1.8 Levothyroxine Sodium for amplifying information**

CAPSULE; ORAL
TIROSINT
INST BIOCHIMIQUE
XX
INSTITUT BIOCHIMIQUE
XX
XX
XX
XX
XX
XX
XX
XX
XX +

0.013MG
0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG

N022121
N021924
N021924
N021924
N021924
N021924
N021924
N021924
N021924
N021924

POWDER; INTRAVENOUS

LEVOTHYROXINE SODIUM

XX + APP PHARMS
XX +
XX +

100MCG/VIAL
200MCG/VIAL
500MCG/VIAL

N202231 001
N202231 002
N202231 003

Jun 24, 2011

Jun 24, 2011
Jun 24, 2011

N021342
N021342
N021342
N021342
N021342
N021342
N021342
N021342
N021342
N021342
N021342
N021342

001
002
003
004
005
006
007
012
008
009
010
011

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Dec
Mar
Mar
Mar
Mar

01,
01,
01,
01,
01,
01,
01,
08,
01,
01,
01,
01,

2002
2002
2002
2002
2002
2002
2002
2003
2002
2002
2002
2002

A076752
A076752
A076752
A076752
A076752
A076752

001
002
003
004
005
006

Jun
Jun
Jun
Jun
Jun
Jun

16,
16,
16,
16,
16,
16,

2005
2005
2005
2005
2005
2005

TABLET; ORAL
LEVO-T
-->
ALARA PHARM
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
--> +
LEVOTHYROXINE SODIUM
-->
MERCK KGAA
-->
-->
-->
-->
-->

-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->

AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3

-->
-->
-->
-->
-->
-->

AB2,AB3
AB2,AB3
AB2,AB3
AB2,AB3
AB2,AB3
AB2,AB3

0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG
0.3MG

0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG

001
002
003
004
010
005
008
006
009
007

Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

01,
13,
13,
13,
02,
13,
02,
13,
02,
13,

2007
2006
2006
2006
2009
2006
2009
2006
2009
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 255 (of 424)

LEVOTHYROXINE SODIUM**

**Refer to Preface Section 1.8 Levothyroxine Sodium for amplifying information**

TABLET; ORAL
LEVOTHYROXINE SODIUM
-->
MERCK KGAA
-->
-->
-->
-->
-->
MYLAN
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
LEVOXYL
-->
KING PHARMS
-->
-->
-->
-->
-->
-->
-->
-->
-->
--> +
SYNTHROID
-->
ABBOTT
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
--> +
UNITHROID
-->
STEVENS J
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
--> +

-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->

AB2,AB3 0.125MG
AB2,AB3 0.15MG
AB2,AB3 0.175MG
AB2,AB3 0.2MG
AB2,AB3 0.3MG
AB1,AB2,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
AB1,AB2,AB3,AB4
AB1,AB2,AB3,AB4
AB1,AB2,AB3,AB4
AB1,AB2,AB3,AB4
AB1,AB2,AB3,AB4

A076752
A076752
A076752
A076752
A076752
A076187
A076187
A076187
A076187
A076187
A076187
A076187
A076187
A076187
A076187
A076187
A076187

007
008
009
010
011
001
002
003
004
005
006
007
012
008
009
010
011

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Dec
Jun
Jun
Jun
Jun

16,
16,
16,
16,
16,
05,
05,
05,
05,
05,
05,
05,
13,
05,
05,
05,
05,

2005
2005
2005
2005
2005
2002
2002
2002
2002
2002
2002
2002
2006
2002
2002
2002
2002

-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->

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
N021301
N021301
N021301
N021301
N021301
N021301
N021301
N021301
N021301
N021301

001
002
003
004
005
006
007
008
009
010
011

May
May
May
May
May
May
May
May
May
May
May

25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,

2001
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001

-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->

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
N021402
N021402
N021402
N021402
N021402
N021402
N021402
N021402
N021402
N021402
N021402

001
002
003
004
005
006
007
008
009
010
012
011

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,

2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002

-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->
-->

AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3
AB1,AB2,AB3

N021210
N021210
N021210
N021210
N021210
N021210
N021210
N021210
N021210
N021210
N021210
N021210

001
002
003
004
005
006
007
012
008
009
010
011

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Feb
Aug
Aug
Aug
Aug

21,
21,
21,
21,
21,
21,
21,
08,
21,
21,
21,
21,

2000
2000
2000
2000
2000
2000
2000
2008
2000
2000
2000
2000

0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG
0.3MG

0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG
0.3MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 256 (of 424)

LEVOTHYROXINE SODIUM**

**Refer to Preface Section 1.8 Levothyroxine Sodium for amplifying information**

TABLET; ORAL
LEVOTHROID
LLOYD
AB4
AB4
AB4
AB4
AB4
AB4
AB4
AB4
AB4
AB4
AB4
AB4 +

001
002
003
010
004
011
005
012
006
007
008
009

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Dec
Oct
Oct
Oct
Oct

24,
24,
24,
24,
24,
24,
24,
07,
24,
24,
24,
24,

2002
2002
2002
2002
2002
2002
2002
2004
2002
2002
2002
2002

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
N021116
N021116
N021116
N021116
N021116
N021116
N021116
N021116
N021116
N021116
N021116

OINTMENT; TOPICAL
LIDOCAINE
AT + FOUGERA
NOVOCOL INC
AT
TARO
AT

5%
5%
5%

A080198 001
A040911 001
A086724 001

May 23, 2011

PATCH; TOPICAL

LIDODERM

XX + TEIKOKU PHARMA USA

5%

N020612 001

Mar 19, 1999

GEL; OPHTHALMIC

AKTEN

XX + AKORN

3.5%

N022221 001

Oct 07, 2008

INJECTABLE; INJECTION
LIDOCAINE HYDROCHLORIDE
HOSPIRA
AP
AP
AP
AP
AP
AP
AP
LUITPOLD
AP
AP
STRIDES ARCOLAB LTD
AP
AP
AP
AP
LIDOCAINE HYDROCHLORIDE
B BRAUN
AP
BAXTER HLTHCARE
AP
LIDOCAINE HYDROCHLORIDE
B BRAUN
AP
BAXTER HLTHCARE
AP
LIDOCAINE HYDROCHLORIDE
HOSPIRA
AP
LIDOCAINE HYDROCHLORIDE
B BRAUN
AP
BAXTER HLTHCARE
AP
LIDOCAINE HYDROCHLORIDE
HOSPIRA
AP

0.5%
1%
1%
2%
2%
2%
20%
1%
2%
0.5%
0.5%
1%
1%
0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
200MG/100ML
200MG/100ML
0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
400MG/100ML
400MG/100ML
0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER
400MG/100ML
0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
800MG/100ML
800MG/100ML
0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER
800MG/100ML

A088328
A083158
A088329
A040078
A083158
A088294
A083158
A080850
A083198
A091056
A091058
A091056
A091058

May 17, 1984

LIDOCAINE

LIDOCAINE HYDROCHLORIDE

001
001
001
001
002
001
003
001
001
001
001
002
002

May 17, 1984

Jun 23, 1995
May 17, 1984

Dec
Sep
Dec
Sep

08,
30,
08,
30,

2010
2010
2010
2010

N019830 002
N018461 002

Apr 08, 1992

N019830 003
N018461 003

Apr 08, 1992

N018388 002
N019830 004
N018461 004

Apr 08, 1992

Feb 22, 1982

N018388 003

Nov 05, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 257 (of 424)

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
APP PHARMS
1%
AP
HOSPIRA
AP
0.5%
AP
1%
AP
2%
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
ABRAXIS PHARM
AP
2%
AP
4%
APP PHARMS
AP
1%
AP
2%
HOSPIRA
AP
1%
AP
1.5%
4%
AP
INTL MEDICATION
20%
AP
STRIDES ARCOLAB LTD
AP
2%
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER
HOSPIRA
AP
1%
AP
2%
LIDOPEN
MERIDIAN MEDCL TECHN 10%
AP
XYLOCAINE
AP + APP PHARMS
0.5%
AP +
1%
AP +
1.5%
AP +
2%
XYLOCAINE 4% PRESERVATIVE FREE
AP + APP PHARMS
4%
XYLOCAINE DENTAL
AP + DENTSPLY PHARM
2%
XYLOCAINE PRESERVATIVE FREE
AP + APP PHARMS
1%
AP +
2%
AP +
4%
AP +
10%
AP +
20%
INJECTABLE; SPINAL

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%

5%
XX + HOSPIRA

AT
AT
AT
AT
AT
AT

AT
AT
AT
AT
AT

JELLY; TOPICAL
ANESTACON
POLYMEDICA
LIDOCAINE HYDROCHLORIDE
AKORN
HI TECH PHARMA
INTL MEDICATION
TEVA PHARMS
XYLOCAINE
+ OAK PHARMS
SOLUTION; ORAL
LIDOCAINE HYDROCHLORIDE
HI TECH PHARMA
WOCKHARDT
LIDOCAINE HYDROCHLORIDE
VINTAGE
LIDOCAINE VISCOUS
ROXANE
XYLOCAINE VISCOUS
+ APP PHARMS

A088586
A088325
A088299
A088327

001
001
001
001

N017584
N017584
A080404
A080404
A080408
A080408
A088295
N017702
A090665

001
002
002
003
001
002
001
001
001

A040302 001
A040302 002

Jul
Jul
Jul
Jul

24,
31,
31,
31,

1985
1984
1984
1984

May 17, 1984

Sep 27, 2010
Sep 28, 1998
Sep 28, 1998

N017549 001
N006488
N006488
N006488
N006488

008
007
010
002

N010417 001
N021380 001
N016801
N016801
N016801
N016801
N016801

005
001
002
003
004

Jan 19, 1988

A083914 001

2%

A080429 001

2%
2%
2%
2%

A040433
A040837
A086283
A081318

2%

N008816 001

2%
2%
VISCOUS
2%

A040014 001
A087872 001

Jul 10, 1995

Nov 18, 1982

A040708 001

Feb 27, 2007

2%

A088802 001

Apr 26, 1985

2%

N009470 001

001
001
001
001

Feb 12, 2003

Mar 23, 2011
Apr 29, 1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 258 (of 424)

LIDOCAINE HYDROCHLORIDE

AT
AT
AT
AT
AT
AT

SOLUTION; TOPICAL
LARYNG-O-JET KIT
INTL MEDICATION
4%
LIDOCAINE HYDROCHLORIDE
ROXANE
4%
VINTAGE
4%
WOCKHARDT
4%
LTA II KIT
HOSPIRA
4%
XYLOCAINE 4% PRESERVATIVE FREE
+ APP PHARMS
4%

A086364 001
A088803 001
A040710 001
A087881 001

Apr 03, 1985

Feb 27, 2007
Nov 18, 1982

A080409 001
N010417 002

LIDOCAINE; PRILOCAINE
CREAM; TOPICAL
EMLA
+ OAK PHARMS
2.5%;2.5%
LIDOCAINE AND PRILOCAINE
HI TECH PHARMA
2.5%;2.5%
NYCOMED US
2.5%;2.5%
TOLMAR
2.5%;2.5%

N019941 001

Dec 30, 1992

A076290 001
A076453 001
A076320 001

Sep 25, 2003

Aug 18, 2003
Aug 27, 2003

N021451 001

Dec 19, 2003

CREAM; TOPICAL

LIDOCAINE AND TETRACAINE

7%;7%
XX + GALDERMA LABS LP

N021717 001

Jun 29, 2006

PATCH; TOPICAL

SYNERA

XX + ZARS PHARM

70MG;70MG

N021623 001

Jun 23, 2005

5MG

N201280 001

May 02, 2011

EQ 300MG BASE/ML

N050317 001

LOTION; TOPICAL
LINDANE
OLTA PHARMS
AT
AT + WOCKHARDT

1%
1%

A087313 001
A088190 001

Aug 16, 1984

SHAMPOO; TOPICAL
LINDANE
OLTA PHARMS
AT
AT + WOCKHARDT

1%
1%

A087266 001
A088191 001

Sep 18, 1984

100MG/5ML

N021132 001

Apr 18, 2000

AB
AB
AB
AB

GEL; PERIODONTAL

ORAQIX

XX + DENTSPLY PHARM

2.5%;2.5%

LIDOCAINE; TETRACAINE

LINAGLIPTIN
TABLET; ORAL

TRADJENTA

XX + BOEHRINGER INGELHEIM

LINCOMYCIN HYDROCHLORIDE
INJECTABLE; INJECTION

LINCOCIN

XX + PHARMACIA AND UPJOHN

LINDANE

LINEZOLID
FOR SUSPENSION; ORAL

ZYVOX

XX + PHARMACIA AND UPJOHN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 259 (of 424)

LINEZOLID
INJECTABLE; INJECTION

ZYVOX

XX + PHARMACIA AND UPJOHN

200MG/100ML

N021131 001

Apr 18, 2000

TABLET; ORAL

ZYVOX

XX + PHARMACIA AND UPJOHN

600MG

N021130 002

Apr 18, 2000

EQ 0.01MG BASE/ML

A076923 001

Aug 17, 2005

EQ 0.01MG BASE/ML

N020105 001

Dec 31, 1991

EQ 0.005MG BASE
EQ 0.025MG BASE
EQ 0.05MG BASE

N010379 001
N010379 002
N010379 003

EQ
EQ
EQ
EQ
EQ
EQ

A090097
A090097
A090097
A090326
A090326
A090326

LIOTHYRONINE SODIUM
INJECTABLE; INJECTION
LIOTHYRONINE SODIUM
X GEN PHARMS
AP
TRIOSTAT
AP + JHP PHARMS
TABLET; ORAL
CYTOMEL
KING PHARMS
AB
AB
AB +
LIOTHYRONINE SODIUM
COASTAL PHARMS
AB
AB
AB
MYLAN
AB
AB
AB

0.005MG BASE
0.025MG BASE
0.05MG BASE
0.005MG BASE
0.025MG BASE
0.05MG BASE

001
002
003
001
002
003

Mar
Mar
Mar
Jul
Jul
Jul

20,
20,
20,
14,
14,
14,

2009
2009
2009
2009
2009
2009

LIOTRIX (T4;T3)

XX
XX
XX
XX
XX

TABLET; ORAL

THYROLAR-0.25

FOREST LABS
THYROLAR-0.5

FOREST LABS
THYROLAR-1

FOREST LABS
THYROLAR-2

FOREST LABS
THYROLAR-3

+ FOREST LABS

0.0125MG;0.0031MG

N016807 001

0.025MG;0.0063MG

N016807 005

0.05MG;0.0125MG

N016807 004

0.1MG;0.025MG

N016807 002

0.15MG;0.0375MG

N016807 003

18MG/3ML (6MG/ML)

N022341 001

Jan 25, 2010

20MG
30MG
40MG
50MG
60MG
70MG

N021977
N021977
N021977
N021977
N021977
N021977

Dec
Feb
Dec
Feb
Dec
Feb

2.5MG

A076102 001

LIRAGLUTIDE RECOMBINANT
SOLUTION; SUBCUTANEOUS

VICTOZA

XX + NOVO NORDISK INC

LISDEXAMFETAMINE DIMESYLATE
CAPSULE; ORAL
VYVANSE
XX
SHIRE DEVELOPMENT
XX
XX
XX
XX
XX +

004
001
005
002
006
003

10,
23,
10,
23,
10,
23,

2007
2007
2007
2007
2007
2007

LISINOPRIL
TABLET; ORAL
LISINOPRIL
APOTEX INC
AB

Sep 30, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 260 (of 424)

LISINOPRIL
TABLET; ORAL
LISINOPRIL
APOTEX INC
AB
AB
AB
AB
AB
AUROBINDO
AB
AB
AB
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
AB
AB
AB
LEK PHARMS
AB
AB
AB
AB
AB
AB
LUPIN
AB
AB
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
PRINSTON INC
AB
AB
AB
AB
AB
AB
RANBAXY
AB
AB
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
2.5MG
5MG
5MG
10MG
10MG
20MG
20MG
30MG
30MG

A076102
A076102
A076102
A076102
A076102
A077622
A077622
A077622
A077622
A077622
A077622
A075752
A075752
A075752
A075752
A075752
A075752
A075999
A075999
A075999
A075999
A075999
A075999
A077321
A077321
A077321
A077321
A077321
A077321
A076071
A076071
A076071
A076071
A076071
A076071
A076180
A076180
A076180
A076164
A076164
A076164
A075944
A075944
A075944
A075944
A075944
A075944
A075903
A075994
A075903
A075994
A075903
A075994
A075903
A075994
A075903
A075994

002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
001
002
003
001
002
003
004
006
005
001
001
002
002
003
003
004
004
005
005

Sep
Sep
Sep
Sep
Sep
Feb
Feb
Feb
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Sep
Sep
Sep
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Feb
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

30,
30,
30,
30,
30,
22,
22,
22,
22,
22,
22,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
09,
09,
09,
09,
09,
09,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
11,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,

2002
2002
2002
2002
2002
2006
2006
2006
2006
2006
2006
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2005
2005
2005
2005
2005
2005
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2003
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 261 (of 424)

LISINOPRIL
TABLET; ORAL
LISINOPRIL
SANDOZ
AB
AB
VINTAGE
AB
AB
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
AB
AB
WEST WARD
AB
AB
AB
AB
AB
AB
WOCKHARDT
AB
AB
AB
AB
AB
AB
PRINIVIL
MERCK
AB
AB
AB
AB
ZESTRIL
ASTRAZENECA
AB
AB
AB
AB
AB
AB +

40MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG
2.5MG
5MG
10MG
20MG
30MG
40MG

A075903
A075994
A075743
A075743
A075743
A075743
A075743
A075743
A076059
A076059
A076059
A076059
A076059
A076059
A076063
A076063
A076063
A076063
A076063
A076063
A078402
A078402
A078402
A078402
A078402
A078402

006
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
006
005
001
002
003
004
005
006

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jun
Jul
Apr
Apr
Apr
Apr
Apr
Apr

01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
27,
01,
19,
19,
19,
19,
19,
19,

2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2003
2002
2007
2007
2007
2007
2007
2007

5MG
10MG
20MG
40MG

N019558
N019558
N019558
N019558

001
002
003
004

Dec
Dec
Dec
Oct

29,
29,
29,
25,

1987
1987
1987
1988

2.5MG
5MG
10MG
20MG
30MG
40MG

N019777
N019777
N019777
N019777
N019777
N019777

005
001
002
003
006
004

Apr
May
May
May
Jan
May

29,
19,
19,
19,
20,
19,

1993
1988
1988
1988
1999
1988

150MG
300MG
600MG
300MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG

A079159
A079159
A079159
A076795
A079139
A079139
A079139
A090702
A090702
A090702
N017812
N017812
N017812
A076243
A076243

001
002
003
001
001
002
003
001
002
003
002
001
003
002
001

Jan
Jan
Jan
Nov
Feb
Feb
Feb
Sep
Sep
Sep
Jan

12,
12,
12,
22,
03,
03,
03,
25,
25,
25,
28,

2009
2009
2009
2004
2009
2009
2009
2009
2009
2009
1987

LITHIUM CARBONATE

CAPSULE; ORAL

LITHIUM CARBONATE
ALEMBIC LTD
AB
AB
AB
APOTEX INC
AB
GLENMARK GENERICS
AB
AB
AB
HETERO DRUGS LTD
AB
AB
AB
ROXANE
AB
AB
AB +
WEST WARD
AB
AB

Jan 28, 1987

Feb 24, 2003
Jun 27, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 262 (of 424)

LITHIUM CARBONATE
CAPSULE; ORAL
LITHIUM CARBONATE
WEST WARD
AB

600MG

A078763 001

Apr 15, 2008

TABLET; ORAL
LITHIUM CARBONATE
AB + ROXANE
SUN PHARM INDS INC
AB
WEST WARD
AB

300MG
300MG
300MG

N018558 001
A091027 001
A078715 001

Jan 29, 1982

Jun 24, 2010
Dec 28, 2010

A091544
A091616
A076832
A076691
A076490

Dec
Feb
Oct
Jan
Jun

TABLET, EXTENDED RELEASE; ORAL

LITHIUM CARBONATE
GLENMARK GENERICS
AB
300MG
AB
450MG
ROXANE
AB
300MG
AB +
450MG
WEST WARD
AB
450MG
LITHOBID
AB + NOVEN THERAP
300MG

001
001
001
001
001

27,
14,
28,
05,
17,

2010
2011
2004
2004
2003

N018027 001

LITHIUM CITRATE
SYRUP; ORAL
LITHIUM CITRATE
AA + ROXANE
WOCKHARDT
AA

EQ 300MG CARBONATE/5ML
EQ 300MG CARBONATE/5ML

N018421 001
A070755 001

May 21, 1986

N020191 001

Sep 23, 1993

LODOXAMIDE TROMETHAMINE
SOLUTION/DROPS; OPHTHALMIC

ALOMIDE

XX + ALCON
EQ 0.1% BASE

LOMUSTINE
CAPSULE; ORAL

CEENU

BRISTOL MYERS SQUIBB

XX
XX
XX +

10MG
40MG
100MG

N017588 001

N017588 002

N017588 003

LOPERAMIDE HYDROCHLORIDE
CAPSULE; ORAL
IMODIUM
AB + MCNEIL CONS
2MG
LOPERAMIDE HYDROCHLORIDE
MYLAN
AB
2MG
TEVA
AB
2MG

N017694 001
A072741 001
A073192 001

Sep 18, 1991

Apr 30, 1992

LOPINAVIR; RITONAVIR
CAPSULE; ORAL

KALETRA

XX + ABBOTT

133.3MG;33.3MG

N021226 001

Sep 15, 2000

SOLUTION; ORAL

KALETRA

XX + ABBOTT

80MG/ML;20MG/ML

N021251 001

Sep 15, 2000

TABLET; ORAL
KALETRA
XX
ABBOTT
XX +

100MG;25MG
200MG;50MG

N021906 002
N021906 001

Nov 09, 2007

Oct 28, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 263 (of 424)

LORAZEPAM

AA
AA
AA
AA

CONCENTRATE; ORAL
LORAZEPAM
AMNEAL PHARMS
PADDOCK LLC
PHARM ASSOC
LORAZEPAM INTENSOL
+ ROXANE

2MG/ML
2MG/ML
2MG/ML

A091383 001
A079244 001
A090260 001

Dec 23, 2009

Apr 28, 2009
Jun 15, 2010

2MG/ML

A072755 001

Jun 28, 1991

INJECTABLE; INJECTION
ATIVAN
AP + BAXTER HLTHCARE CORP 2MG/ML
AP +
4MG/ML
LORAZEPAM
BEDFORD
2MG/ML
AP
4MG/ML
AP
HOSPIRA
2MG/ML
AP
2MG/ML
AP
2MG/ML
AP
4MG/ML
AP
4MG/ML
AP
INTL MEDICATION SYS
AP
2MG/ML
TAYLOR
AP
2MG/ML
WATSON LABS
AP
2MG/ML
AP
4MG/ML
LORAZEPAM PRESERVATIVE FREE
BEDFORD LABS
AP
2MG/ML
AP
4MG/ML
TABLET; ORAL
ATIVAN
VALEANT INTL
AB
AB
AB +
LORAZEPAM
ACTAVIS ELIZABETH
AB
AB
AB
AMNEAL PHARMS
AB
AB
AB
EXCELLIUM
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
RANBAXY
AB
AB
AB
SANDOZ
AB
AB
AB
VINTAGE PHARMS
AB
AB
AB

N018140 001
N018140 002
A077076
A077076
A074243
A074282
A074300
A074243
A074282
A076150
A075025
A074276
A074276

001
002
001
001
001
002
002
001
001
001
002

A077074 001
A077074 002

0.5MG
1MG
2MG

N017794 001
N017794 002
N017794 003

0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
0.5MG
1MG
1MG
2MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG

A071403
A071404
A071141
A078826
A078826
A078826
A078203
A078203
A078203
A077396
A077396
A077396
A071589
A077657
A071590
A077657
A071591
A077657
A076045
A076045
A076045
A071193
A071194
A071195
A077754
A077754
A077754

001
001
001
001
002
003
001
002
003
001
002
003
001
001
001
002
001
003
001
002
003
001
001
001
001
002
003

Jul
Jul
Apr
May
Apr
Apr
May
Nov
Jul
Apr
Apr

13,
13,
12,
27,
12,
12,
27,
15,
23,
15,
15,

2005
2005
1994
1994
1994
1994
1994
2004
1998
1994
1994

Jul 13, 2005

Jul 13, 2005

Apr
Apr
Apr
Jun
Jun
Jun
Jul
Jul
Jul
Dec
Dec
Dec
Oct
Mar
Oct
Mar
Oct
Mar
Aug
Aug
Aug
Apr
Apr
Apr
May
May
May

21,
21,
21,
23,
23,
23,
30,
30,
30,
13,
13,
13,
13,
16,
13,
16,
13,
16,
29,
29,
29,
15,
15,
15,
10,
10,
10,

1987
1987
1987
2010
2010
2010
2007
2007
2007
2006
2006
2006
1987
2006
1987
2006
1987
2006
2001
2001
2001
1988
1988
1988
2006
2006
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 264 (of 424)

LORAZEPAM
TABLET; ORAL
LORAZEPAM
WATSON LABS
AB
AB
AB
AB

001
001
001
001

Oct
Jul
Oct
Oct

31,
24,
31,
31,

1991
1986
1991
1991

0.5MG
1MG
1MG
2MG

A072926
A071118
A072927
A072928

25MG
50MG
100MG

N020386 001
N020386 002
N020386 003

Apr 14, 1995

Apr 14, 1995
Oct 13, 1998

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

A090382
A090382
A090382
A090428
A090428
A090428
A090790
A090790
A090790
A090083
A090083
A090083
A078232
A078232
A078232
A091590
A091590
A091590
A091497
A091497
A091497
A077459
A077459
A077459
A077424
A077424
A077424
A076958
A076958
A076958
A090467
A090467
A090467
A090544
A090544
A090544
A091129
A091129
A091129
A078243
A078243
A078243

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

LOSARTAN POTASSIUM
TABLET; ORAL
COZAAR
MERCK
AB
AB
AB +
LOSARTAN POTASSIUM
ACTAVIS INC
AB
AB
AB
ALEMBIC PHARMS LTD
AB
AB
AB
APOTEX CORP
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
LUPIN LTD
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
WATSON LABS
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB
AB

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

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

2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2011
2011
2011
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 265 (of 424)

LOTEPREDNOL ETABONATE
OINTMENT; OPHTHALMIC

LOTEMAX

XX + BAUSCH AND LOMB

0.5%

N200738 001

Apr 15, 2011

SUSPENSION/DROPS; OPHTHALMIC

ALREX

0.2%
XX + BAUSCH AND LOMB
LOTEMAX
0.5%
XX + BAUSCH AND LOMB

N020803 001

Mar 09, 1998

N020583 001

Mar 09, 1998

N050804 001

Dec 14, 2004

10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
10MG
20MG
20MG
40MG
40MG
10MG
10MG
20MG
20MG
40MG
40MG
10MG
20MG
40MG

A075828
A075828
A075828
A077748
A077748
A077748
A075991
A075991
A075991
A078296
A078296
A078296
A077520
A077520
A077520
A075451
A075935
A075451
A075935
A075451
A075935
A075300
A075636
A075300
A075636
A075300
A075636
A075551
A075551
A075551

Dec
Dec
Dec
Feb
Feb
Feb
Jun
Jun
Jun
Mar
Nov
Nov
Apr
Apr
Apr
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

20MG
40MG

N019643 003
N019643 004

Aug 31, 1987

Dec 14, 1988

TABLET, EXTENDED RELEASE; ORAL

ALTOPREV
ANDRX LABS LLC
20MG
XX
40MG
XX
60MG
XX +

N021316 002
N021316 003
N021316 004

Jun 26, 2002

Jun 26, 2002
Jun 26, 2002

LOTEPREDNOL ETABONATE; TOBRAMYCIN

SUSPENSION/DROPS; OPHTHALMIC

ZYLET

XX + BAUSCH AND LOMB

0.5%;0.3%

LOVASTATIN
TABLET; ORAL
LOVASTATIN
ACTAVIS ELIZABETH
AB
AB
AB
APOTEX INC
AB
AB
AB
CARLSBAD
AB
AB
AB
LUPIN
AB
AB
AB
MUTUAL PHARM
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
AB
AB
TEVA
AB
AB
AB
MEVACOR
MERCK
AB
AB +

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
001
002
002
003
003
003
002
001

17,
17,
17,
28,
28,
28,
05,
05,
05,
14,
01,
01,
14,
14,
14,
17,
17,
17,
17,
17,
17,
17,
17,
17,
17,
17,
17,
17,
17,
17,

2001
2001
2001
2007
2007
2007
2002
2002
2002
2008
2007
2007
2006
2006
2006
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 266 (of 424)

LOVASTATIN; NIACIN

XX
XX
XX
XX

TABLET, EXTENDED RELEASE; ORAL

ADVICOR

+ ABBOTT
20MG;500MG
+
20MG;750MG
+
20MG;1GM
+
40MG;1GM

N021249
N021249
N021249
N021249

001
002
003
004

Dec
Dec
Dec
Apr

17,
17,
17,
27,

2001
2001
2001
2006

A090695
A090695
A090695
A090695
A076762
A076762
A076762
A076762
A072204
A072205
A072206
A072062

001
002
003
004
001
002
003
004
001
001
001
001

Sep
Sep
Sep
Sep
Nov
Nov
Nov
Nov
Jun
Jun
Jun
Jun

26,
26,
26,
26,
01,
01,
01,
01,
15,
15,
15,
15,

2011
2011
2011
2011
2004
2004
2004
2004
1988
1988
1988
1988

LOXAPINE SUCCINATE
CAPSULE; ORAL
LOXAPINE SUCCINATE
LANNETT HOLDINGS INC
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
WATSON LABS
AB
AB
AB +
AB

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
25MG BASE
50MG BASE
5MG BASE
10MG BASE
25MG BASE
50MG BASE
5MG BASE
10MG BASE
25MG BASE
50MG BASE

LUBIPROSTONE
CAPSULE; ORAL
AMITIZA
SUCAMPO PHARMS
XX
XX +

8MCG
24MCG

N021908 002
N021908 001

Apr 29, 2008

Jan 31, 2006

40MG
80MG

N200603 001
N200603 002

Oct 28, 2010

Oct 28, 2010

75 IU/VIAL

N021322 001

Oct 08, 2004

CREAM; TOPICAL

SULFAMYLON

XX + UDL LABS

EQ 85MG BASE/GM

N016763 001

FOR SOLUTION; TOPICAL

SULFAMYLON

XX + UDL LABS

5%

N019832 003

LURASIDONE HYDROCHLORIDE
TABLET; ORAL
LATUDA
SUNOVION
XX
XX +

LUTROPIN ALFA
INJECTABLE; SUBCUTANEOUS

LUVERIS

XX + EMD SERONO

MAFENIDE ACETATE

Jun 05, 1998

MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE; INJECTION
PLASMA-LYTE 56 IN PLASTIC CONTAINER
BAXTER HLTHCARE
32MG/100ML;128MG/100ML;234MG/100ML
XX

N019047 001

Jun 15, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 267 (of 424)

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

30MG/100ML;37MG/100ML;0.82MG/100ML;370M
XX + B BRAUN
G/100ML;530MG/100ML;500MG/100ML;12MG/10
0ML

N019696 001

Sep 29, 1989

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM

GLUCONATE

AP

AP

XX

XX

INJECTABLE; INJECTION
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
BAXTER HLTHCARE
30MG/100ML;37MG/100ML;368MG/100ML;526MG
/100ML;502MG/100ML
PLASMA-LYTE A IN PLASTIC CONTAINER
BAXTER HLTHCARE
30MG/100ML;37MG/100ML;368MG/100ML;526MG
/100ML;502MG/100ML
ISOLYTE S IN PLASTIC CONTAINER
B BRAUN
30MG/100ML;37MG/100ML;370MG/100ML;530MG
/100ML;500MG/100ML
NORMOSOL-R IN PLASTIC CONTAINER
HOSPIRA
30MG/100ML;37MG/100ML;222MG/100ML;526MG
/100ML;502MG/100ML

SOLUTION; IRRIGATION
PHYSIOLYTE IN PLASTIC CONTAINER
B BRAUN
30MG/100ML;37MG/100ML;370MG/100ML;530MG
XX
/100ML;500MG/100ML
PHYSIOSOL IN PLASTIC CONTAINER
HOSPIRA
30MG/100ML;37MG/100ML;222MG/100ML;526MG
XX
/100ML;502MG/100ML

N017378 001

N017378 002

Nov 22, 1982

N019711 001

Sep 29, 1989

N017586 001

N019024 001

Jun 08, 1984

N017637 002

Jul 08, 1982

0.21GM/100ML;2.8GM/100ML;9.07GM/100ML

N021910 001

Jul 26, 2006

0.21GM/100ML;3.97GM/100ML;8.3GM/100ML

N021910 002

Jul 26, 2006

N022456 001
N022456 002

Dec 04, 2009

Dec 04, 2009

N019316 001
A075151 001

Sep 08, 1986

Apr 25, 2000

N020488 001
N020488 002

Jul 11, 1995

Jul 11, 1995

N020309 003
N020309 001
N020309 002

Jan 26, 2007

Jun 24, 1994
Jun 24, 1994

N022372 001

Aug 05, 2010

MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

SOLUTION; INJECTION

NORMOCARB HF 25

XX + DIALYSIS SUPS
NORMOCARB HF 35
XX + DIALYSIS SUPS

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

TABLET; ORAL

MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

SANTARUS
343MG;20MG;750MG

XX
343MG;40MG;750MG
XX +

MAGNESIUM SULFATE

AP
AP
XX
XX
XX
XX
XX

INJECTABLE; INJECTION
MAGNESIUM SULFATE
+ ABRAXIS PHARM
500MG/ML
HOSPIRA
500MG/ML
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
+ HOSPIRA
1GM/100ML
+
2GM/100ML
MAGNESIUM SULFATE IN PLASTIC CONTAINER

HOSPIRA
2GM/50ML (40MG/ML)

+
4GM/100ML (40MG/ML)
+
4GM/50ML (80MG/ML)

MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE

SOLUTION; ORAL

SUPREP BOWEL PREP KIT

XX + BRAINTREE LABS

1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

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PRESCRIPTION DRUG PRODUCT LIST

3 - 268 (of 424)

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM

CHLORIDE; SODIUM PHOSPHATE
SOLUTION; IRRIGATION
TIS-U-SOL
BAXTER HLTHCARE
AT

N018508 001

AT

N018336 001

20MG/100ML;40MG/100ML;6.25MG/100ML;800M
G/100ML;8.75MG/100ML
TIS-U-SOL IN PLASTIC CONTAINER
BAXTER HLTHCARE
20MG/100ML;40MG/100ML;6.25MG/100ML;800M
G/100ML;8.75MG/100ML

Feb 19, 1982

MALATHION
LOTION; TOPICAL
MALATHION
SYNERX PHARMA
AT
OVIDE
AT + TARO PHARMS NORTH

0.5%

A078743 001

Mar 06, 2009

0.5%

N018613 001

Aug 02, 1982

N018962 001

Jun 26, 1986

MANGANESE CHLORIDE
INJECTABLE; INJECTION
MANGANESE CHLORIDE IN PLASTIC CONTAINER
HOSPIRA
EQ 0.1MG MANGANESE/ML
XX

MANNITOL

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
MANNITOL 10%
B BRAUN
10GM/100ML
MANNITOL 10% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML
HOSPIRA
10GM/100ML
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER
B BRAUN
10GM/100ML
MANNITOL 15%
B BRAUN
15GM/100ML
MANNITOL 15% IN PLASTIC CONTAINER
B BRAUN
15GM/100ML
HOSPIRA
15GM/100ML
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
B BRAUN
15GM/100ML
MANNITOL 20%
B BRAUN
20GM/100ML
20GM/100ML
MANNITOL 20% IN PLASTIC CONTAINER
B BRAUN
20GM/100ML
HOSPIRA
20GM/100ML
MANNITOL 25%
APP PHARMS
12.5GM/50ML
HOSPIRA
12.5GM/50ML
INTL MEDICATION
12.5GM/50ML
LUITPOLD
12.5GM/50ML
MANNITOL 5%
B BRAUN
5GM/100ML
MANNITOL 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML
HOSPIRA
5GM/100ML
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%
B BRAUN
5GM/100ML
OSMITROL 10% IN WATER
BAXTER HLTHCARE
10GM/100ML
OSMITROL 10% IN WATER IN PLASTIC CONTAINER
BAXTER HLTHCARE
10GM/100ML

N016080 002
N020006 002
N019603 002

Jul 26, 1993

Jan 08, 1987

N016080 006
N016080 003
N020006 003
N019603 003

Jul 26, 1993

Jan 08, 1990

N016080 005
N014738 001
N016080 004
N020006 004
N019603 004
A080677
N016269
A083051
A087409

001
006
001
001

Jul 26, 1993

Jan 08, 1990

Aug 25, 1994

Jan 21, 1982

N016080 001
N020006 001
N019603 001
N016080 007
N013684 002
N013684 006

Jul 26, 1993

Jan 08, 1987

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PRESCRIPTION DRUG PRODUCT LIST

3 - 269 (of 424)

MANNITOL

AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
OSMITROL 15% IN WATER
BAXTER HLTHCARE
15GM/100ML
OSMITROL 15% IN WATER IN PLASTIC CONTAINER
BAXTER HLTHCARE
15GM/100ML
OSMITROL 20% IN WATER
BAXTER HLTHCARE
20GM/100ML
OSMITROL 20% IN WATER IN PLASTIC CONTAINER
BAXTER HLTHCARE
20GM/100ML
OSMITROL 5% IN WATER
BAXTER HLTHCARE
5GM/100ML
OSMITROL 5% IN WATER IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML

POWDER; INHALATION

ARIDOL KIT

XX + PHARMAXIS

N/A,5MG,10MG,20MG,40MG

SOLUTION; IRRIGATION

RESECTISOL IN PLASTIC CONTAINER

B BRAUN
5GM/100ML
XX

N013684 004
N013684 008
N013684 003
N013684 007
N013684 001
N013684 005

N022368 001

Oct 05, 2010

N016772 002

MANNITOL; SORBITOL
SOLUTION; IRRIGATION

SORBITOL-MANNITOL IN PLASTIC CONTAINER

XX
HOSPIRA
540MG/100ML;2.7GM/100ML

N018316 001

MAPROTILINE HYDROCHLORIDE
TABLET; ORAL
MAPROTILINE HYDROCHLORIDE
MYLAN
25MG
XX
50MG
XX +
75MG
XX

A072285 002
A072285 001
A072285 003

Oct 03, 1988

Oct 03, 1988
Oct 03, 1988

150MG
300MG

N022128 001
N022128 002

Aug 06, 2007

Aug 06, 2007

100MG

A073580 001

Jan 04, 1995

40MG/4ML (10MG/ML)

N021839 001

Aug 30, 2005

MARAVIROC
TABLET; ORAL
SELZENTRY
VIIV HLTHCARE
XX
XX +

MEBENDAZOLE
TABLET, CHEWABLE; ORAL

MEBENDAZOLE

XX + TEVA PHARMS

MECASERMIN RECOMBINANT
INJECTABLE; SUBCUTANEOUS

INCRELEX

XX + TERCICA

MECHLORETHAMINE HYDROCHLORIDE
INJECTABLE; INJECTION

MUSTARGEN

XX + LUNDBECK INC

10MG/VIAL

N006695 001

12.5MG
25MG

N010721 006
N010721 004

MECLIZINE HYDROCHLORIDE
TABLET; ORAL
ANTIVERT
AA + PFIZER
AA +

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PRESCRIPTION DRUG PRODUCT LIST

3 - 270 (of 424)

MECLIZINE HYDROCHLORIDE
TABLET; ORAL
ANTIVERT
AA + PFIZER
50MG
MECLIZINE HYDROCHLORIDE
AMNEAL PHARMS
AA
12.5MG
AA
25MG
AA
50MG
JUBILANT CADISTA
AA
12.5MG
AA
25MG
PAR PHARM
AA
12.5MG
AA
25MG
AA
50MG
SANDOZ
AA
12.5MG
AA
25MG
VINTAGE PHARMS
AA
12.5MG
AA
25MG
WATSON LABS
AA
25MG

N010721 001

Jan 20, 1982

A201451
A201451
A201451
A040659
A040659
A087127
A087128
A089674
A084843
A084092
A040179
A040179
A085740

001
002
003
001
002
001
001
001
002
003
001
002
001

Feb
Feb
Feb
Jun
Jun

23,
23,
23,
04,
04,

2011
2011
2011
2010
2010

Mar
May
May
Jan
Jan

31,
22,
22,
30,
30,

1988
1989
1989
1997
1997

A071081
A071081
A071468
A071469

002
001
001
001

Sep
Sep
Apr
Apr

03,
03,
15,
15,

1986
1986
1987
1987

MECLOFENAMATE SODIUM
CAPSULE; ORAL
MECLOFENAMATE SODIUM
MYLAN
AB
AB +
WATSON LABS
AB
AB

EQ
EQ
EQ
EQ

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

MEDROXYPROGESTERONE ACETATE

AB
AB
AB
AB
XX

INJECTABLE; INJECTION
DEPO-PROVERA
+ PHARMACIA AND UPJOHN 150MG/ML
MEDROXYPROGESTERONE ACETATE
SANDOZ
150MG/ML
TEVA PARENTERAL
150MG/ML
150MG/ML
DEPO-PROVERA
+ PHARMACIA AND UPJOHN 400MG/ML

INJECTABLE; SUBCUTANEOUS

DEPO-SUBQ PROVERA 104

XX + PHARMACIA AND UPJOHN

104MG/0.65ML

TABLET; ORAL
MEDROXYPROGESTERONE ACETATE
BARR
AB
2.5MG
AB
5MG
AB
10MG
PROVERA
PHARMACIA AND UPJOHN 2.5MG
AB
AB
5MG
AB +
10MG
MEDROXYPROGESTERONE ACETATE
BP
USL PHARMA
10MG

N020246 001

Oct 29, 1992

A078711 001
A076552 001
A076553 001

May 20, 2009

Oct 27, 2004
Jul 28, 2004

N012541 003

N021583 001

Dec 17, 2004

A040159 001
A040159 002
A040159 003

Aug 09, 1996

Aug 09, 1996
Aug 09, 1996

N011839 001
N011839 003
N011839 004
A088484 001

Jul 26, 1984

250MG
250MG

A091322 001
A090562 001

Jul 22, 2011

Nov 19, 2010

250MG

N015034 003

MEFENAMIC ACID
CAPSULE; ORAL
MEFENAMIC ACID
LUPIN LTD
AB
MICRO LABS LTD
AB
PONSTEL
AB + SHIONOGI INC

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PRESCRIPTION DRUG PRODUCT LIST

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MEFLOQUINE HYDROCHLORIDE

AB
AB
AB
AB

TABLET; ORAL
MEFLOQUINE HYDROCHLORIDE
BARR
250MG
ROXANE
250MG
+ SANDOZ
250MG
WEST WARD
250MG

A076392
A076523
A076175
A077699

001
001
001
001

Dec
Oct
Feb
Apr

29,
01,
20,
21,

2003
2004
2002
2010

MEGESTROL ACETATE
SUSPENSION; ORAL
MEGACE
+ BRISTOL MYERS SQUIBB
MEGESTROL ACETATE
APOTEX INC
PAR PHARM
ROXANE
TEVA PHARMS
WOCKHARDT
MEGACE ES
+ PAR PHARM

40MG/ML

N020264 001

Sep 10, 1993

40MG/ML
40MG/ML
40MG/ML
40MG/ML
40MG/ML

A077404
A075671
A075997
A075681
A076721

Feb
Jul
Feb
May
Nov

125MG/ML

N021778 001

Jul 05, 2005

20MG
40MG
20MG
40MG
20MG
40MG

A074621
A074621
A072422
A072423
A074458
A074458

Aug
Nov
Aug
Aug
Sep
Sep

SUSPENSION; ORAL

MOBIC

XX + BOEHRINGER INGELHEIM

7.5MG/5ML

N021530 001

Jun 01, 2004

TABLET; ORAL
MELOXICAM
APOTEX INC
AB
AB
AUROBINDO PHARMA
AB
AB
BEIJING DOUBLE CRANE
AB
AB
BRECKENRIDGE PHARM
AB
AB
CARACO
AB
AB
CARLSBAD
AB
AB
COREPHARMA
AB
AB
DR REDDYS LABS INC
AB
AB
GLENMARK GENERICS
AB
AB
LUPIN PHARMS
AB
AB
MYLAN
AB
AB
AB
AB
PURACAP PHARM
AB

7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
7.5MG
15MG
15MG
7.5MG

A077882
A077882
A078008
A078008
A078039
A078039
A077920
A077920
A077937
A077937
A077918
A077918
A077930
A077930
A077931
A077931
A077932
A077932
A077944
A077944
A077923
A077934
A077923
A077934
A077938

Jul
Jul
Oct
Oct
Dec
Dec
Jul
Jul
Jul
Jul
Dec
Dec
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

AB
AB
AB
AB
AB
AB
XX

TABLET; ORAL
MEGESTROL ACETATE
BARR
AB
AB
PAR PHARM
AB
AB +
ROXANE
AB
AB

001
001
001
001
001

002
001
001
001
001
002

16,
25,
15,
05,
01,

16,
30,
08,
08,
29,
29,

2006
2001
2002
2003
2004

1996
1995
1988
1988
1995
1995

MELOXICAM

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
001
002
002
001

20,
20,
02,
02,
14,
14,
19,
19,
19,
19,
07,
07,
19,
19,
25,
25,
19,
19,
19,
19,
19,
20,
19,
20,
19,

2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006

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PRESCRIPTION DRUG PRODUCT LIST

3 - 272 (of 424)

MELOXICAM
TABLET; ORAL
MELOXICAM
PURACAP PHARM
AB
STRIDES ARCOLAB LTD
AB
AB
TARO
AB
AB
TEVA PHARMS
AB
AB
UNICHEM
AB
AB
WATSON LABS
AB
AB
ZYDUS PHARMS USA
AB
AB
MOBIC
BOEHRINGER INGELHEIM
AB
AB +

002
001
002
001
002
001
002
001
002
001
002
001
002

Jul
May
May
Nov
Nov
Jul
Jul
Dec
Dec
Jul
Jul
Jul
Jul

19,
13,
13,
07,
07,
19,
19,
20,
20,
19,
19,
19,
19,

2006
2009
2009
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006

15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG
7.5MG
15MG

A077938
A077928
A077928
A078102
A078102
A077936
A077936
A077927
A077927
A077929
A077929
A077921
A077921

7.5MG
15MG

N020938 001
N020938 002

2MG

N014691 002

EQ 50MG BASE/VIAL

N020207 001

Nov 18, 1992

EQ 50MG BASE/VIAL
EQ 50MG BASE/VIAL
EQ 50MG BASE/VIAL

A090303 001
A090299 001
A090270 001

Oct 28, 2010

Oct 27, 2009
Jun 09, 2009

CAPSULE, EXTENDED RELEASE; ORAL

NAMENDA XR
FOREST LABS
7MG
XX
14MG
XX
21MG
XX
28MG
XX +

N022525
N022525
N022525
N022525

Jun
Jun
Jun
Jun

SOLUTION; ORAL

NAMENDA

XX + FOREST LABS

2MG/ML

N021627 001

Apr 18, 2005

TABLET; ORAL
NAMENDA
XX
FOREST LABS
XX +

5MG
10MG

N021487 001
N021487 002

Oct 16, 2003

Oct 16, 2003

INJECTABLE; IM-SC

REPRONEX

XX + FERRING

75 IU/VIAL;75 IU/VIAL

N021047 001

Aug 27, 1999

INJECTABLE; SUBCUTANEOUS

MENOPUR

XX + FERRING

75 IU/VIAL;75 IU/VIAL

N021663 001

Oct 29, 2004

Apr 13, 2000

Aug 23, 2000

MELPHALAN
TABLET; ORAL

ALKERAN

XX + GLAXOSMITHKLINE

MELPHALAN HYDROCHLORIDE

AP
AP
AP
AP

INJECTABLE; INJECTION
ALKERAN
+ GLAXOSMITHKLINE
MELPHALAN HYDROCHLORIDE
BEDFORD LABS
BIONICHE PHARMA USA
SYNERX

MEMANTINE HYDROCHLORIDE

001
002
003
004

21,
21,
21,
21,

2010
2010
2010
2010

MENOTROPINS (FSH;LH)

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PRESCRIPTION DRUG PRODUCT LIST

3 - 273 (of 424)

MEPENZOLATE BROMIDE
TABLET; ORAL

CANTIL

XX + SANOFI AVENTIS US

25MG

N010679 003

MEPERIDINE HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
DEMEROL
+ HOSPIRA
25MG/ML
+
50MG/ML
+
75MG/ML
+
100MG/ML
MEPERIDINE HYDROCHLORIDE
BAXTER HLTHCARE CORP 25MG/ML
50MG/ML
75MG/ML
100MG/ML
ELKINS SINN
25MG/ML
50MG/ML
75MG/ML
100MG/ML
WATSON LABS
50MG/ML
100MG/ML
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
BAXTER HLTHCARE CORP 10MG/ML
+ HOSPIRA
10MG/ML
INTL MEDICATION
10MG/ML
WATSON LABS
10MG/ML

SYRUP; ORAL

MEPERIDINE HYDROCHLORIDE

50MG/5ML
XX + ROXANE

AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
XX
XX

TABLET; ORAL
DEMEROL
+ SANOFI AVENTIS US
50MG
+
100MG
MEPERIDINE HYDROCHLORIDE
BARR
50MG
100MG
CARACO
50MG
100MG
EPIC PHARMA
50MG
100MG
MALLINCKRODT
50MG
100MG
MIKART
50MG
100MG
ROXANE
50MG
100MG
VINTAGE PHARMS
50MG
100MG
WATSON LABS
50MG
100MG
MEPERIDINE HYDROCHLORIDE
MIKART
75MG
150MG

N021171
N021171
N021171
N021171

001
002
003
004

A080455
A080455
A080455
A080455
A080445
A080445
A080445
A080445
A073444
A073445

007
008
009
010
001
002
003
004
001
001

Mar 17, 1992

Mar 17, 1992

A081002
A088432
A081309
A073443

001
001
001
001

Jul
Aug
Aug
Mar

A088744 001

1%

1993
1984
1993
1992

Jan 30, 1985

N005010 001
N005010 004
A088639
A088640
A040446
A040446
A040331
A040331
A040352
A040352
A040893
A040893
A040110
A040110
A040191
A040191
A040186
A040186

001
001
001
002
001
002
001
002
001
003
001
002
001
002
001
002

A040893 002
A040893 004

MEPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION
CARBOCAINE
AP + HOSPIRA

30,
16,
30,
17,

N012250 001

Jul
Sep
Aug
Aug
May
May
Jun
Jun
Jun
Jun
Mar
Mar
Dec
Dec
Jun
Jun

02,
19,
08,
08,
28,
28,
13,
13,
24,
24,
12,
12,
17,
17,
30,
30,

1984
1984
2002
2002
1999
1999
2000
2000
2009
2009
1997
1997
1998
1998
1997
1997

Jun 24, 2009

Jun 24, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 274 (of 424)

MEPIVACAINE HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
CARBOCAINE
+ HOSPIRA
1.5%
+
2%
ISOCAINE HYDROCHLORIDE
+ NOVOCOL
3%
MEPIVACAINE HYDROCHLORIDE
HOSPIRA INC
3%
WATSON LABS
1%
2%
POLOCAINE
APP PHARMS
1%
2%
DENTSPLY PHARM
3%
POLOCAINE-MPF
APP PHARMS
1%
1.5%
2%
SCANDONEST PLAIN
+ DEPROCO
3%

N012250 005
N012250 002
A080925 001
A040806 001
A088769 001
A088770 001

Apr 28, 2008

Nov 20, 1984
Nov 20, 1984

A089407 001
A089410 001
A088653 001

Dec 01, 1986

Dec 01, 1986
Aug 21, 1984

A089406 001
A089408 001
A089409 001

Dec 01, 1986

Dec 01, 1986
Dec 01, 1986

A088387 001

Oct 10, 1984

200MG
400MG
200MG
400MG
200MG
400MG
200MG
400MG

A090122
A090122
A040797
A040797
A200998
A200998
A083304
A083308

Feb
Feb
Feb
Feb
May
May

2%;0.01%

N020922 001

Dec 10, 1999

50MG
50MG
50MG

A040594 001
A040461 001
A040528 001

Jul 01, 2005

Feb 11, 2004
Feb 13, 2004

50MG

N009053 002

500MG/VIAL
1GM/VIAL
500MG/VIAL
1GM/VIAL
500MG/VIAL
1GM/VIAL

A091404
A091404
A090940
A090940
A091201
A091201

500MG/VIAL
1GM/VIAL

N050706 003
N050706 001

MEPROBAMATE
TABLET; ORAL
MEPROBAMATE
ALEMBIC PHARMS LTD
AA
AA
INVAGEN PHARMS
AA
AA
TARO
AA
AA
AA + WATSON LABS
AA +

001
002
001
002
001
002
001
001

18,
18,
27,
27,
23,
23,

2009
2009
2008
2008
2011
2011

MEQUINOL; TRETINOIN
SOLUTION; TOPICAL

SOLAGE

XX + AQUA PHARMS

MERCAPTOPURINE

AB
AB
AB
AB

TABLET; ORAL
MERCAPTOPURINE
MYLAN
PROMETHEUS LABS
ROXANE
PURINETHOL
+ TEVA

MEROPENEM
INJECTABLE; INJECTION
MEROPENEM
ACS DOBFAR
AP
AP
HOSPIRA INC
AP
AP
SANDOZ
AP
AP
MERREM
AP + ASTRAZENECA
AP +

001
002
001
002
001
002

Oct
Oct
Jun
Jun
Mar
Mar

26,
26,
22,
22,
29,
29,

2011
2011
2010
2010
2011
2011

Jun 21, 1996

Jun 21, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 275 (of 424)

MESALAMINE
CAPSULE, EXTENDED RELEASE; ORAL

APRISO

375MG
XX + SALIX PHARMS
PENTASA
SHIRE
250MG
XX
500MG
XX +

N022301 001

Oct 31, 2008

N020049 001
N020049 002

May 10, 1993

Jul 08, 2004

4GM/60ML
4GM/60ML

A076751 001
A076841 001

Sep 17, 2004

Sep 30, 2004

4GM/60ML

N019618 001

Dec 24, 1987

4GM/60ML

N019618 002

Jun 20, 2008

1GM

N021252 002

Nov 05, 2004

N019651 001

Jan 31, 1992

N021830 001

May 29, 2008

N022000 001

Jan 16, 2007

100MG/ML
100MG/ML
100MG/ML
100MG/ML

A075811
A075739
A090913
A075764

Apr
Jan
Apr
Apr

100MG/ML

N019884 001

Dec 30, 1988

400MG

N020855 001

Mar 21, 2002

0.05MG;1MG

N016659 001

SOLUTION; INHALATION
METAPROTERENOL SULFATE
AN + DEY
AN +
NOVEX
AN
AN
WOCKHARDT
AN
AN

0.4%
0.6%
0.4%
0.6%
0.4%
0.6%

A071786
A070804
A075402
A075403
A075586
A075586

SYRUP; ORAL
METAPROTERENOL SULFATE
NOVEX
AA
AA + SILARX

10MG/5ML
10MG/5ML

A075235 001
A073632 001

AB
AB
AB
AB

ENEMA; RECTAL
MESALAMINE
PERRIGO ISRAEL
TEVA
ROWASA
+ MEDA PHARMS
SFROWASA
MEDA PHARMS

SUPPOSITORY; RECTAL

CANASA

XX + AXCAN

TABLET, DELAYED RELEASE; ORAL

ASACOL

400MG
XX + WARNER CHILCOTT LLC
ASACOL HD
800MG
XX + WARNER CHILCOTT LLC
LIALDA
1.2GM
XX + SHIRE

MESNA

AP
AP
AP
AP
AP

INJECTABLE; INTRAVENOUS
MESNA
APP PHARMS
BEDFORD
SAGENT STRIDES
TEVA PARENTERAL
MESNEX
+ BAXTER HLTHCARE

TABLET; ORAL

MESNEX

XX + BAXTER HLTHCARE

001
001
001
001

26,
09,
13,
27,

2001
2004
2010
2001

MESTRANOL; NORETHINDRONE
TABLET; ORAL-28

NORINYL 1+50 28-DAY

XX + WATSON LABS

METAPROTERENOL SULFATE

001
001
001
001
001
002

Aug
Aug
Feb
Feb
May
May

05,
17,
28,
28,
30,
30,

1988
1987
2001
2001
2002
2002

Jan 27, 2000

Jul 22, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 276 (of 424)

METAPROTERENOL SULFATE
TABLET; ORAL
METAPROTERENOL SULFATE
PAR PHARM
AB
AB +
WATSON LABS
AB
AB

10MG
20MG
10MG
20MG

A072024
A072025
A073013
A072795

001
001
001
001

Jun
Jun
Jan
Jan

28,
28,
31,
31,

1988
1988
1991
1991

METARAMINOL BITARTRATE
INJECTABLE; INJECTION

METARAMINOL BITARTRATE

EQ 10MG BASE/ML
XX + APP PHARMS

A080722 001

METAXALONE
TABLET; ORAL
METAXALONE
SANDOZ
AB
SKELAXIN
AB + KING PHARMS

800MG

A040445 001

Mar 31, 2010

800MG

N013217 003

Aug 30, 2002

500MG/5ML

N021591 001

Sep 11, 2003

500MG
850MG
1GM

N020357 001
N020357 002
N020357 005

Mar 03, 1995

Mar 03, 1995
Nov 05, 1998

500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
500MG
850MG
850MG
1GM
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM
500MG
850MG
1GM

A091184
A091184
A091184
A075969
A075969
A075969
A076033
A076033
A076033
A077880
A077880
A077880
A075984
A090666
A075984
A090666
A075984
A090666
A077095
A077095
A077095
A075967
A075967
A075967
A077787
A077787
A077787
A078170
A078170
A078170

Nov
Nov
Nov
Jan
Jan
Jan
Jan
Jan
Jan
Jun
Jun
Jun
Apr
Dec
Apr
Dec
Apr
Dec
Jan
Jan
Jan
Jan
Jan
Jan
Aug
Aug
Aug
May
May
May

METFORMIN HYDROCHLORIDE
SOLUTION; ORAL

RIOMET

XX + RANBAXY
TABLET; ORAL
GLUCOPHAGE
BRISTOL MYERS SQUIBB
AB
AB
AB +
METFORMIN HYDROCHLORIDE
ALKEM
AB
AB
AB
ALPHAPHARM
AB
AB
AB
ALVOGEN
AB
AB
AB
AMNEAL PHARMS NY
AB
AB
AB
APOTEX
AB
AB
AB
AB
AB
AB
AUROBINDO
AB
AB
AB
CARACO
AB
AB
AB
DR REDDYS LABS INC
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB

001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003
001
002
003
001
002
003

01,
01,
01,
29,
29,
29,
24,
24,
24,
05,
05,
05,
23,
07,
23,
07,
23,
07,
14,
14,
14,
29,
29,
29,
23,
23,
23,
23,
23,
23,

2010
2010
2010
2002
2002
2002
2002
2002
2002
2006
2006
2006
2002
2011
2002
2011
2002
2011
2005
2005
2005
2002
2002
2002
2006
2006
2006
2008
2008
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 277 (of 424)

METFORMIN HYDROCHLORIDE
TABLET; ORAL
METFORMIN HYDROCHLORIDE
GRANULES INDIA
AB
500MG
AB
850MG
AB
1GM
INDICUS PHARMA
AB
500MG
AB
850MG
AB
1GM
IVAX SUB TEVA PHARMS 500MG
AB
AB
850MG
AB
1GM
MUTUAL PHARMA
AB
500MG
AB
850MG
AB
1GM
MYLAN
AB
500MG
AB
500MG
AB
850MG
AB
850MG
AB
1GM
AB
1GM
PROVIDENT PHARM
AB
500MG
AB
850MG
AB
1GM
SANDOZ
AB
500MG
AB
500MG
AB
850MG
AB
850MG
AB
1GM
AB
1GM
TEVA
AB
500MG
AB
850MG
AB
1GM
TORRENT PHARMS
AB
500MG
AB
850MG
AB
1GM
WATSON LABS
AB
500MG
AB
850MG
AB
1GM
WATSON LABS FLORIDA
AB
500MG
AB
850MG
AB
1GM
ZYDUS PHARMS USA
AB
500MG
AB
850MG
AB
1GM
METFORMIN HYDROCHLORIDE
IVAX SUB TEVA PHARMS 625MG
XX
750MG
XX

AB
AB
AB
AB
AB
AB
AB
AB

TABLET, EXTENDED RELEASE;

FORTAMET
+ ANDRX LABS LLC
GLUCOPHAGE XR
+ BRISTOL MYERS SQUIBB
METFORMIN HYDROCHLORIDE
ALVOGEN
AMNEAL PHARMS NY
APOTEX
BARR
IMPAX LABS
LUPIN LTD

A090564
A090564
A090564
A079148
A079148
A079148
A075972
A075972
A075972
A076038
A076038
A076038
A075973
A075976
A075973
A075976
A075973
A075976
A077853
A077853
A077853
A075965
A075985
A075965
A075985
A075965
A075985
A075978
A075978
A075978
A077711
A077711
A077711
A075979
A075979
A075979
A075961
A075961
A075961
A077064
A077064
A077064

001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Apr
Apr
Apr
Nov
Nov
Nov
Jan
Jan
Jan
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Jan
Jan
Jul
Jul
Jul
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Nov
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Apr
Apr
Apr

22,
22,
22,
25,
25,
25,
24,
24,
24,
21,
21,
21,
25,
24,
25,
24,
25,
24,
28,
28,
28,
25,
25,
25,
25,
25,
25,
25,
25,
05,
24,
24,
24,
24,
24,
24,
25,
25,
25,
18,
18,
18,

2010
2010
2010
2008
2008
2008
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2006
2006
2006
2002
2002
2002
2002
2002
2002
2002
2002
2002
2007
2007
2007
2002
2002
2002
2002
2002
2002
2005
2005
2005

A075972 005
A075972 004

Jan 24, 2002

Jan 24, 2002

1GM

N021574 002

Apr 27, 2004

750MG

N021202 004

Apr 11, 2003

750MG
750MG
750MG
750MG
750MG
1GM

A078321
A078596
A076706
A076863
A076985
A090692

Apr
Jan
Dec
Oct
Sep
Jun

ORAL

002
002
002
001
001
002

17,
03,
29,
14,
13,
29,

2008
2008
2005
2004
2005
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 278 (of 424)

METFORMIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;
METFORMIN HYDROCHLORIDE
MYLAN
AB
RANBAXY
AB
SUN PHARM INDS (IN)
AB
TEVA
AB
TORRENT PHARMS
AB
WATSON LABS FLORIDA
AB
ZYDUS PHARMS USA
AB
GLUCOPHAGE XR
BRISTOL MYERS SQUIBB
AB1
METFORMIN HYDROCHLORIDE
ALVOGEN
AB1
AMNEAL PHARMS NY
AB1
APOTEX
AB1
IMPAX LABS
AB1
MYLAN
AB1
NOSTRUM
AB1
RANBAXY LABS LTD
AB1
SANDOZ
AB1
SUN PHARM INDS (IN)
AB1
TEVA
AB1
TORRENT PHARM
AB1
WATSON LABS FLORIDA
AB1
WATSON LABS INC
AB1
ZYDUS PHARMS USA
AB1
FORTAMET
ANDRX LABS LLC
AB2
METFORMIN HYDROCHLORIDE
LUPIN LTD
AB2
GLUMETZA
BX
SANTARUS
BX +

ORAL
001
001
002
001
001
001
001

Sep
Jun
Feb
Apr
Feb
Apr
Apr

08,
29,
09,
12,
18,
12,
21,

2005
2005
2006
2005
2010
2005
2005

750MG
750MG
750MG
750MG
750MG
750MG
750MG

A077113
A077211
A077336
A076864
A079226
A076869
A077078

500MG

N021202 001

Oct 13, 2000

500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG

A078321
A078596
A076706
A076249
A076650
A076756
A076413
A076873
A077336
A076269
A090014
A076172
A076818
A077060

Apr
Jan
Dec
Jul
Sep
Jul
Jun
Dec
Feb
Jun
Dec
Jun
Dec
Apr

500MG

N021574 001

Apr 27, 2004

500MG

A090692 001

Jun 29, 2011

500MG
1GM

N021748 001
N021748 002

Jun 03, 2005

Jun 03, 2005

N021842 001
N021842 002

Aug 29, 2005

Aug 29, 2005

A090406 001
A090406 002

Feb 25, 2011

Feb 25, 2011

N022024 001
N022024 002

May 12, 2009

May 12, 2009

N022386 001
N022386 002

Jun 23, 2008

Jun 23, 2008

N021410 002
N021410 003
N021410 004

Oct 10, 2002

Oct 10, 2002
Aug 25, 2003

001
001
001
001
001
001
001
001
001
001
001
001
001
001

17,
03,
14,
30,
13,
26,
18,
14,
09,
18,
30,
16,
14,
20,

2008
2008
2004
2004
2005
2006
2004
2004
2006
2004
2009
2004
2004
2005

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

AB
AB
AB
AB

TABLET; ORAL
ACTOPLUS MET
TAKEDA GLOBAL
500MG;EQ 15MG BASE
+
850MG;EQ 15MG BASE
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
MYLAN
500MG;EQ 15MG BASE
850MG;EQ 15MG BASE

TABLET, EXTENDED RELEASE; ORAL

ACTOPLUS MET XR
TAKEDA GLOBAL
1GM;EQ 15MG BASE
XX
1GM;EQ 30MG BASE
XX +

METFORMIN HYDROCHLORIDE; REPAGLINIDE

TABLET; ORAL
PRANDIMET
NOVO NORDISK INC
XX
XX +

500MG;1MG
500MG;2MG

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

TABLET; ORAL
AVANDAMET
SB PHARMCO
XX
XX
XX

500MG;EQ 2MG BASE

500MG;EQ 4MG BASE
1GM;EQ 2MG BASE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 279 (of 424)

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

TABLET; ORAL

AVANDAMET

XX + SB PHARMCO

1GM;EQ 4MG BASE

N021410 005

Aug 25, 2003

N200678 001
N200678 003
N200678 002

Nov 05, 2010

Nov 05, 2010
Nov 05, 2010

500MG;EQ 50MG BASE

1GM;EQ 50MG BASE

N022044 001
N022044 002

Mar 30, 2007

Mar 30, 2007

100MG/VIAL

N019193 001

Oct 31, 1986

10MG/ML
10MG/ML
INTENSOL
10MG/ML

A040180 001
A040088 001

Apr 30, 1998

Nov 30, 1994

A089897 001

Sep 06, 1988

10MG/ML

N017116 002

INJECTABLE; INJECTION

DOLOPHINE HYDROCHLORIDE

10MG/ML
XX + MYLAN INSTITUTIONAL

N021624 001

POWDER; FOR RX COMPOUNDING

METHADONE HYDROCHLORIDE

MALLINCKRODT
50GM/BOT
XX
100GM/BOT
XX
500GM/BOT
XX

N006383 002

N006383 003

N006383 004

SOLUTION; ORAL
METHADONE HYDROCHLORIDE
AA + ROXANE
5MG/5ML
AA +
10MG/5ML
VISTAPHARM
AA
5MG/5ML
AA
10MG/5ML

A087393
A087997
A090707
A090707

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN

TABLET, EXTENDED RELEASE; ORAL
KOMBIGLYZE XR
BRISTOL MYERS SQUIBB 500MG;5MG
XX
1GM;2.5MG
XX
1GM;5MG
XX +

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

TABLET; ORAL
JANUMET
MERCK
XX
XX +

METHACHOLINE CHLORIDE
FOR SOLUTION; INHALATION

PROVOCHOLINE

XX + METHAPHARM

METHADONE HYDROCHLORIDE

AA
AA
AA
AA

CONCENTRATE; ORAL
METHADONE HYDROCHLORIDE
ROXANE
VISTAPHARM
METHADONE HYDROCHLORIDE
ROXANE
METHADOSE
+ MALLINCKRODT

TABLET; ORAL
DOLOPHINE HYDROCHLORIDE
AA + ROXANE
5MG
AA +
10MG
METHADONE HYDROCHLORIDE
MALLINCKRODT
AA
5MG
AA
10MG
AA
40MG
AA + ROXANE
40MG
SANDOZ
AA
10MG
AA
40MG
THE PHARMANETWORK
AA
10MG

001
001
001
002

Aug 30, 1982

Jun 30, 2010
Jun 30, 2010

N006134 002
N006134 010
A040517
A040517
A077142
N017058
A040241
A075082
A090635

001
002
001
001
002
001
001

Apr 27, 2004

Apr 27, 2004
Jul 12, 2005
May 29, 1998
Mar 25, 1998
Nov 25, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 280 (of 424)

METHADONE HYDROCHLORIDE
TABLET; ORAL
METHADOSE
MALLINCKRODT
AA
AA
AA

5MG
10MG
40MG

A040050 001
A040050 002
A074184 001

Apr 15, 1993

Apr 15, 1993
Apr 29, 1993

METHAMPHETAMINE HYDROCHLORIDE
TABLET; ORAL
DESOXYN
AA + LUNDBECK INC
5MG
METHAMPHETAMINE HYDROCHLORIDE
COASTAL PHARMS
AA
5MG

N005378 002
A091189 001

Apr 21, 2010

25MG
50MG
25MG
50MG
25MG
50MG

A040062
A040062
A040036
A040036
A040001
A040001

Jan
Jan
Jun
Jun
Jun
Jun

1GM

N017681 001

1GM

A076411 001

1GM

N016151 001

5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG

A040870
A040870
A040547
A040547
A040734
A040734
A040350
A040350
A040411
A040411

5MG
10MG

A040320 001
A040320 002

100MG/ML

A086459 001

100MG/ML

N011790 001

500MG

A200958 001

METHAZOLAMIDE
TABLET; ORAL
METHAZOLAMIDE
MIKART
AB
AB +
SANDOZ
AB
AB
TEVA PHARMS
AB
AB

001
002
001
002
001
002

27,
27,
30,
30,
30,
30,

1994
1994
1993
1993
1993
1993

METHENAMINE HIPPURATE
TABLET; ORAL
HIPREX
AB + SANOFI AVENTIS US
METHENAMINE HIPPURATE
COREPHARMA
AB
UREX
CNTY LINE PHARMS
AB

Jun 20, 2003

METHIMAZOLE
TABLET; ORAL
METHIMAZOLE
CARACO
AB
AB
CEDAR PHARMS
AB
AB
EMCURE PHARMS USA
AB
AB
MYLAN
AB
AB +
SANDOZ
AB
AB
TAPAZOLE
KING PHARMS
AB
AB

001
002
001
002
001
002
001
002
001
002

Sep
Sep
Feb
Feb
Dec
Dec
Mar
Mar
Mar
Mar

25,
25,
18,
18,
14,
14,
29,
29,
27,
27,

2007
2007
2005
2005
2007
2007
2000
2000
2001
2001

Mar 31, 2000

Mar 31, 2000

METHOCARBAMOL
INJECTABLE; INJECTION
METHOCARBAMOL
WATSON LABS
AP
ROBAXIN
AP + BAXTER HLTHCARE CORP
TABLET; ORAL
METHOCARBAMOL
AUSTARPHARMA LLC
AA

Oct 21, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 281 (of 424)

METHOCARBAMOL
TABLET; ORAL
METHOCARBAMOL
AUSTARPHARMA LLC
AA
HETERO DRUGS
AA
AA
LANNETT HOLDINGS INC
AA
AA
SANDOZ
AA
AA
VINTAGE PHARMS
AA
AA
WATSON LABS
AA
AA
AA
AA
WEST WARD
AA
AA
ROBAXIN
AA + SCHWARZ PHARMA
ROBAXIN-750
AA + SCHWARZ PHARMA

750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
500MG
750MG
750MG
500MG
750MG

A200958
A090200
A090200
A084756
A084756
A084616
A084615
A040489
A040489
A084277
A085180
A084276
A085192
A085159
A085123

002
001
002
002
001
001
001
001
002
001
001
002
001
001
001

500MG

N011011 004

750MG

N011011 006

500MG/VIAL
2.5GM/VIAL

N011559 001
N011559 002

Oct
Nov
Nov
Mar

21,
06,
06,
31,

2011
2009
2009
2003

Jan 29, 2003

Jan 29, 2003

METHOHEXITAL SODIUM
INJECTABLE; INJECTION

BREVITAL SODIUM

XX + JHP PHARMS
XX +

METHOTREXATE SODIUM

XX

INJECTABLE; INJECTION
METHOTREXATE SODIUM
+ APP PHARMS
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
+
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
+ HOSPIRA
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
METHOTREXATE SODIUM PRESERVATIVE FREE
+ BEDFORD
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
+
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
+ BIONICHE PHARMA
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
+ BIONICHE PHARMA USA
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
+
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
EBEWE PHARMA
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
+ HOSPIRA
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
PHARMACHEMIE BV
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
EQ 250MG/10ML (EQ 25MG BASE/ML)
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
METHOTREXATE SODIUM
+ BEDFORD
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
+
EQ 200MG BASE/8ML (EQ 25MG BASE/ML)
METHOTREXATE SODIUM PRESERVATIVE FREE
+ BEDFORD
EQ 1GM BASE/VIAL

AB
AB
AB
AB

TABLET; ORAL
METHOTREXATE SODIUM
BARR
+ DAVA PHARMS INC
MYLAN
ROXANE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
XX
XX

EQ
EQ
EQ
EQ

2.5MG
2.5MG
2.5MG
2.5MG

BASE
BASE
BASE
BASE

A040263 001
A040263 002
N011719 010

Feb 26, 1999

Feb 26, 1999
Dec 15, 2004

A089340
A089343
A040767
A040768
A040716
A090039
A090039
A090029
N011719
A040850
A040853
A040843

Sep
Sep
Apr
Apr
Apr
Mar
Mar
Mar
Apr
Jan
Jan
Jan

001
001
001
001
001
001
002
001
012
001
001
001

16,
16,
30,
30,
30,
31,
31,
31,
13,
11,
11,
11,

1986
1986
2007
2007
2007
2009
2009
2009
2005
2010
2010
2010

A089341 001
A089342 001

Sep 16, 1986

Sep 16, 1986

A040632 001

Aug 12, 2005

A081099
N008085
A081235
A040054

Oct 15, 1990

001
002
001
001

May 15, 1992

Aug 01, 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 282 (of 424)

METHOTREXATE SODIUM
TABLET; ORAL
TREXALL
BARR
XX
XX
XX
XX +

EQ
EQ
EQ
EQ

5MG BASE
7.5MG BASE
10MG BASE
15MG BASE

A040385
A040385
A040385
A040385

001
002
003
004

Mar
Mar
Mar
Mar

21,
21,
21,
21,

2001
2001
2001
2001

METHOXSALEN
CAPSULE; ORAL

8-MOP

XX + VALEANT PHARM INTL

OXSORALEN-ULTRA

XX + VALEANT PHARM INTL

10MG

N009048 001

10MG

N019600 001

Oct 30, 1986

INJECTABLE; INJECTION

UVADEX

XX + THERAKOS

0.02MG/ML

N020969 001

Feb 25, 1999

LOTION; TOPICAL

OXSORALEN

XX + VALEANT PHARM INTL

1%

N009048 002

METHSCOPOLAMINE BROMIDE
TABLET; ORAL
METHSCOPOLAMINE BROMIDE
BOCA PHARMA
AA
2.5MG
AA
5MG
BRECKENRIDGE PHARM
AA
2.5MG
AA
5MG
PAMINE
AA + FOUGERA PHARMS
2.5MG
PAMINE FORTE
AA + FOUGERA PHARMS
5MG

A040624
A040624
A040642
A040642

001
002
001
002

Dec
Dec
Dec
Dec

28,
28,
06,
06,

2006
2006
2011
2011

N008848 001
N008848 002

Mar 25, 2003

METHSUXIMIDE
CAPSULE; ORAL

CELONTIN

PARKE DAVIS
XX
XX +

150MG
300MG

N010596 007

N010596 008

5MG

N012524 004

5MG
5MG

A087672 001
A088724 001

2.5MG

N012524 001

METHYCLOTHIAZIDE

AB
AB
AB
XX

TABLET; ORAL
ENDURON
+ ABBOTT
METHYCLOTHIAZIDE
MYLAN
WATSON LABS
ENDURON

ABBOTT

Aug 17, 1982

Sep 06, 1984

METHYL AMINOLEVULINATE HYDROCHLORIDE

CREAM; TOPICAL

METVIXIA

XX + GALDERMA LABS LP

EQ 16.8% BASE

N021415 001

Jul 27, 2004

250MG
500MG

A070084 001
A070085 001

Oct 15, 1985

Oct 15, 1985

METHYLDOPA
TABLET; ORAL
METHYLDOPA
ACCORD HLTH
AB
AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 283 (of 424)

METHYLDOPA
TABLET; ORAL
METHYLDOPA
IVAX SUB TEVA PHARMS
AB
AB
MYLAN
AB
AB +
WATSON LABS
AB

250MG
500MG
250MG
500MG
500MG

A070098
A070343
A070075
A070076
A070625

001
001
001
001
001

Feb
Feb
Apr
Apr
Jun

20,
20,
18,
18,
06,

1986
1986
1985
1985
1986

METHYLDOPATE HYDROCHLORIDE
INJECTABLE; INJECTION
METHYLDOPATE HYDROCHLORIDE
AP + LUITPOLD
50MG/ML
TEVA PARENTERAL
AP
50MG/ML

A071279 001
A072974 001

Oct 02, 1987

Nov 22, 1991

METHYLERGONOVINE MALEATE
INJECTABLE; INJECTION
METHERGINE
AP + NOVARTIS
0.2MG/ML
METHYLERGONOVINE MALEATE
ERGOJECT
AP
0.2MG/ML
LUITPOLD
AP
0.2MG/ML
TABLET; ORAL
METHERGINE
AB + NOVARTIS
0.2MG
METHYLERGONOVINE MALEATE
NOVEL LABS INC
AB
0.2MG

N006035 004
A040889 001
A090193 001

Sep 13, 2010

Nov 24, 2008

N006035 003
A091577 001

May 02, 2011

METHYLNALTREXONE BROMIDE
INJECTABLE; SUBCUTANEOUS
RELISTOR
XX
PROGENICS

8MG/0.4ML

N021964 002

Sep 27, 2010

SOLUTION; SUBCUTANEOUS

RELISTOR

XX + PROGENICS

12MG/0.6ML (12MG/0.6ML)

N021964 001

Apr 24, 2008

N021514
N021514
N021514
N021514

Apr
Apr
Apr
Apr

METHYLPHENIDATE
FILM, EXTENDED RELEASE; TRANSDERMAL
DAYTRANA
XX
NOVEN PHARMS INC
10MG/9HR (1.1MG/HR)
XX
15MG/9HR (1.6MG/HR)
XX
20MG/9HR (2.2MG/HR)
XX +
30MG/9HR (3.3MG/HR)

001
002
003
004

06,
06,
06,
06,

2006
2006
2006
2006

METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
METHYLPHENIDATE HYDROCHLORIDE
ACTAVIS
AB
20MG
AB
30MG
AB
40MG
RITALIN LA
NOVARTIS
AB
20MG
AB
30MG
AB +
40MG
METADATE CD
BX
UCB INC
10MG
BX
20MG
BX
30MG
BX
40MG

A078458 001
A078458 002
A078458 003

Dec 01, 2011

Dec 01, 2011
Dec 01, 2011

N021284 001
N021284 002
N021284 003

Jun 05, 2002

Jun 05, 2002
Jun 05, 2002

N021259
N021259
N021259
N021259

May
Apr
Jun
Feb

003
001
002
004

27,
03,
19,
19,

2003
2001
2003
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 284 (of 424)

METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
RITALIN LA
BX
NOVARTIS
10MG
METADATE CD
UCB INC
50MG
XX
60MG
XX +

AA
AA
AA
AA

SOLUTION; ORAL
METHYLIN
+ MALLINCKRODT
5MG/5ML
+
10MG/5ML
METHYLPHENIDATE HYDROCHLORIDE
TRIS PHARMA INC
5MG/5ML
10MG/5ML

TABLET; ORAL
METHYLPHENIDATE HYDROCHLORIDE
MALLINCKRODT
5MG
AB
10MG
AB
20MG
AB
UCB INC
5MG
AB
AB
10MG
AB
20MG
WATSON LABS
AB
5MG
AB
10MG
AB
20MG
RITALIN
NOVARTIS
AB
5MG
AB
10MG
AB +
20MG
TABLET, CHEWABLE; ORAL
METHYLIN
MALLINCKRODT
XX
XX
XX +

N021284 004

Apr 10, 2004

N021259 005
N021259 006

Feb 19, 2006

Feb 19, 2006

N021419 001
N021419 002

Dec 19, 2002

Dec 19, 2002

A091601 001
A091601 002

Jul 23, 2010

Jul 23, 2010

A040300
A040300
A040300
A086429
A085799
A086428
A040220
A040220
A040220

Nov 27, 1998

Nov 27, 1998
Nov 27, 1998

001
002
003
001
001
001
001
002
003

Aug 29, 1997

Aug 29, 1997
Aug 29, 1997

N010187 003
N010187 006
N010187 010

N021475 001
N021475 002
N021475 003

Apr 15, 2003

Apr 15, 2003
Apr 15, 2003

A040306 001
A089601 001

Oct 20, 1999

Jun 01, 1988

A075629 001
A075629 002

May 09, 2000

May 09, 2000

A040410 001

Feb 09, 2001

N018029 001

Mar 30, 1982

N021121
N021121
N021121
N021121

001
004
002
003

Aug
Apr
Aug
Dec

4MG
8MG
16MG
32MG

N011153
N011153
N011153
N011153

001
004
003
006

4MG

A088497 001

2.5MG
5MG
10MG

TABLET, EXTENDED RELEASE; ORAL

METADATE ER
UCB INC
AB
10MG
AB +
20MG
METHYLIN ER
MALLINCKRODT
AB
10MG
AB
20MG
METHYLPHENIDATE HYDROCHLORIDE
WATSON LABS
AB
20MG
RITALIN-SR
NOVARTIS
AB
20MG
CONCERTA
JANSSEN PHARMS
18MG
XX
27MG
XX
36MG
XX
54MG
XX +

01,
01,
01,
08,

2000
2002
2000
2000

METHYLPREDNISOLONE
TABLET; ORAL
MEDROL
PHARMACIA AND UPJOHN
AB
AB
AB
AB +
METHYLPREDNISOLONE
DURAMED PHARMS BARR
AB

Feb 21, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 285 (of 424)

METHYLPREDNISOLONE
TABLET; ORAL
METHYLPREDNISOLONE
JUBILANT CADISTA
AB
AB
AB
AB
SANDOZ
AB
VINTAGE PHARMS
AB
WATSON LABS
AB

4MG
8MG
16MG
32MG
4MG
4MG
4MG

A040189
A040189
A040189
A040189
A040194
A040183
A040232

001
002
003
004
001
001
001

Oct
Oct
Jul
Jul
Oct
Dec
Oct

31,
31,
20,
20,
31,
22,
16,

1997
1997
2007
2007
1997
1998
1997

Jan
Mar
Jan
Mar
Feb
Oct
Feb
Oct

29,
05,
29,
05,
23,
27,
23,
27,

2009
2009
2009
2009
2005
2006
2005
2006

METHYLPREDNISOLONE ACETATE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
XX

INJECTABLE; INJECTION
DEPO-MEDROL
+ PHARMACIA AND UPJOHN 40MG/ML
+
80MG/ML
METHYLPREDNISOLONE ACETATE
SANDOZ
40MG/ML
40MG/ML
80MG/ML
80MG/ML
TEVA PARENTERAL
40MG/ML
40MG/ML
80MG/ML
80MG/ML
DEPO-MEDROL
+ PHARMACIA AND UPJOHN 20MG/ML

N011757 001
N011757 004
A040719
A040794
A040719
A040794
A040557
A040620
A040557
A040620

001
001
002
002
001
001
002
002

N011757 002

METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE; INJECTION
A-METHAPRED
HEMOFARM
AP
EQ 40MG BASE/VIAL
AP
EQ 125MG BASE/VIAL
HOSPIRA
AP
EQ 40MG BASE/VIAL
AP
EQ 125MG BASE/VIAL
METHYLPREDNISOLONE SODIUM SUCCINATE
APP PHARMS
AP
EQ 40MG BASE/VIAL
AP
EQ 125MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
BEDFORD LABS
AP
EQ 40MG BASE/VIAL
AP
EQ 125MG BASE/VIAL
AP
EQ 500MG BASE/VIAL
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 1GM BASE/VIAL
MUSTAFA NEVSAT
AP
EQ 40MG BASE/VIAL
AP
EQ 125MG BASE/VIAL
AP
EQ 500MG BASE/VIAL
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
TEVA PARENTERAL
AP
EQ 125MG BASE/VIAL
SOLU-MEDROL
AP + PHARMACIA AND UPJOHN EQ 40MG BASE/VIAL
AP +
EQ 125MG BASE/VIAL
AP +
EQ 500MG BASE/VIAL
AP +
EQ 1GM BASE/VIAL
AP +
EQ 2GM BASE/VIAL

A040793
A040827
A040664
A040665

001
001
001
001

Nov
Nov
Dec
Dec

25,
25,
20,
20,

2008
2008
2005
2005

A040583
A040583
A040612
A040662
A040641
A040641
A040709
A040641
A040709
A040888
A040888
A040888
A040888
A040888
A081266

001
002
001
001
002
003
001
004
002
001
002
003
004
005
001

Jul
Jul
Aug
Feb
Feb
Feb
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Jul
Nov

30,
30,
12,
21,
21,
21,
21,
21,
21,
18,
18,
18,
18,
18,
30,

2004
2004
2004
2007
2007
2007
2007
2007
2007
2011
2011
2011
2011
2011
1992

N011856
N011856
N011856
N011856
N011856

003
004
005
006
007

Feb 27, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 286 (of 424)

METHYLTESTOSTERONE
CAPSULE; ORAL

TESTRED

XX + VALEANT PHARM INTL

TABLET; ORAL
ANDROID 10
BP
VALEANT PHARM INTL
ANDROID 25
BP + VALEANT PHARM INTL
METHYLTESTOSTERONE
BP
IMPAX LABS
BP

10MG

A083976 001

10MG

A086450 001

25MG

A087147 001

10MG
25MG

A080767 002
A084310 001

METIPRANOLOL HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
METIPRANOLOL
FALCON PHARMS
AT
0.3%
OPTIPRANOLOL
AT + BAUSCH AND LOMB
0.3%

A075720 001

Aug 06, 2001

N019907 001

Dec 29, 1989

A073118 001
A073135 001

Jan 17, 1991

Nov 27, 1991

METOCLOPRAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION
METOCLOPRAMIDE HYDROCHLORIDE
HOSPIRA
AP
EQ 5MG BASE/ML
TEVA PARENTERAL
AP
EQ 5MG BASE/ML
REGLAN
AP + BAXTER HLTHCARE CORP EQ 5MG BASE/ML

AA
AA
AA
AA
AA

SOLUTION; ORAL
METOCLOPRAMIDE HYDROCHLORIDE
ANI PHARMS
EQ 5MG
PHARM ASSOC
EQ 5MG
SILARX
EQ 5MG
VISTAPHARM
EQ 5MG
+ WOCKHARDT
EQ 5MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

N017862 001

A071402
A072744
A073680
A075051
A074703

001
001
001
001
001

Jun
May
Oct
Jan
Oct

25,
28,
27,
26,
31,

1993
1991
1992
2001
1997

A070581
A078807
A078807
A071536
A078374
A078374
A072801
A070184
A077878
A077878
A072750
A071250

001
001
002
002
001
002
001
001
001
002
001
001

Oct
Jun
Jun
Jan
Nov
Nov
Jun
Jul
Aug
Aug
Dec
Feb

17,
12,
12,
16,
30,
30,
15,
29,
28,
28,
28,
03,

1985
2008
2008
1997
2007
2007
1993
1985
2006
2006
1995
1988

TABLET; ORAL
METOCLOPRAMIDE HYDROCHLORIDE
ACTAVIS ELIZABETH
EQ 10MG BASE
IPCA LABS LTD
EQ 5MG BASE
EQ 10MG BASE
MUTUAL PHARM
EQ 5MG BASE
NORTHSTAR HLTHCARE
EQ 5MG BASE
EQ 10MG BASE
TEVA
EQ 5MG BASE
EQ 10MG BASE
VINTAGE PHARMS
EQ 5MG BASE
EQ 10MG BASE
WATSON LABS
EQ 5MG BASE
EQ 10MG BASE
REGLAN
ANI PHARMS
EQ 5MG BASE
+
EQ 10MG BASE

N017854 002
N017854 001

May 05, 1987

TABLET, ORALLY DISINTEGRATING; ORAL

METOZOLV ODT
SALIX PHARMS
EQ 5MG BASE
XX
EQ 10MG BASE
XX +

N022246 001
N022246 002

Sep 04, 2009

Sep 04, 2009

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 287 (of 424)

METOLAZONE
TABLET; ORAL
METOLAZONE
MYLAN
AB
AB
AB
SANDOZ
AB
AB
AB
TEVA
AB
AB
AB
ZAROXOLYN
UCB INC
AB
AB +
AB +

2.5MG
5MG
10MG
2.5MG
5MG
10MG
2.5MG
5MG
10MG

A076698
A076698
A076698
A076732
A076466
A076466
A076600
A076833
A075543

001
002
003
001
001
002
001
001
003

2.5MG
5MG
10MG

N017386 001
N017386 002
N017386 003

Dec
Oct
Oct
Dec
Dec
Dec
Jan
Mar
Dec

23,
19,
19,
19,
19,
19,
06,
01,
24,

2003
2004
2004
2003
2003
2003
2004
2004
2003

METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE; ORAL
METOPROLOL SUCCINATE
MYLAN PHARMS INC
AB
EQ 25MG TARTRATE
AB
EQ 50MG TARTRATE
AB
EQ 100MG TARTRATE
AB
EQ 200MG TARTRATE
NESHER PHARMS
AB
EQ 25MG TARTRATE
AB
EQ 50MG TARTRATE
AB
EQ 100MG TARTRATE
AB
EQ 200MG TARTRATE
SANDOZ
AB
EQ 25MG TARTRATE
AB
EQ 50MG TARTRATE
AB
EQ 100MG TARTRATE
AB
EQ 200MG TARTRATE
WATSON LABS FLORIDA
AB
EQ 25MG TARTRATE
AB
EQ 50MG TARTRATE
AB
EQ 100MG TARTRATE
AB
EQ 200MG TARTRATE
WOCKHARDT
AB
EQ 25MG TARTRATE
AB
EQ 50MG TARTRATE
AB
EQ 100MG TARTRATE
AB
EQ 200MG TARTRATE
TOPROL-XL
ASTRAZENECA
AB
EQ 25MG TARTRATE
AB +
EQ 50MG TARTRATE
AB
EQ 100MG TARTRATE
AB +
EQ 200MG TARTRATE

A202033
A202033
A202033
A202033
A077779
A077176
A076640
A076640
A076969
A076969
A076969
A076969
A077118
A076862
A077298
A077298
A090615
A090615
A090615
A090615

001
002
003
004
001
001
002
001
001
002
003
004
001
001
001
002
001
002
003
004

Dec
Dec
Dec
Dec
Mar
May
May
May
Jul
May
Mar
Mar
Aug
Aug
Apr
Apr
Jul
Jul
Jul
Jul

15,
15,
15,
15,
20,
14,
18,
18,
31,
18,
20,
20,
03,
03,
15,
15,
22,
22,
22,
22,

2011
2011
2011
2011
2008
2008
2007
2007
2006
2007
2008
2008
2009
2009
2010
2010
2010
2010
2010
2010

N019962
N019962
N019962
N019962

004
001
002
003

Feb
Jan
Jan
Jan

05,
10,
10,
10,

2001
1992
1992
1992

METOPROLOL TARTRATE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
LOPRESSOR
+ NOVARTIS
METOPROLOL TARTRATE
APP PHARMS
BEDFORD LABS
HIKMA FARMACEUTICA
HOSPIRA

LUITPOLD
SAGENT STRIDES

1MG/ML

N018704 001

Mar 30, 1984

1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML

A091045
A076495
A077761
A074133
A075160
A078085
A090386
A091307
A090317

Oct
Jul
May
Dec
Jul
Apr
Sep
Dec
Apr

001
001
001
001
001
001
001
001
001

25,
07,
30,
21,
06,
29,
30,
29,
19,

2010
2003
2007
1993
1998
2008
2009
2010
2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 288 (of 424)

METOPROLOL TARTRATE
INJECTABLE; INJECTION
METOPROLOL TARTRATE
SANDOZ
AP
WATSON LABS
AP
TABLET; ORAL
LOPRESSOR
NOVARTIS
AB
AB
METOPROLOL TARTRATE
AUROBINDO PHARMA
AB
AB
AB
CARACO
AB
AB
AB
IPCA LABS LTD
AB
AB
AB
MUTUAL PHARM
AB
AB
AB
MYLAN
AB
AB
AB +
SANDOZ
AB
AB
TEVA
AB
AB
WATSON LABS
AB
AB

Oct 02, 2007

Dec 21, 1993

1MG/ML
1MG/ML

A077360 001
A074032 001

50MG
100MG

N017963 001
N017963 002

25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG

A077739
A077739
A077739
A076670
A074644
A074644
A078459
A078459
A078459
A073654
A073653
A073654
A076704
A076704
A076704
A073288
A073289
A074141
A074141
A074217
A074217

375MG

N020334 001

May 03, 1995

375MG
375MG

A079065 001
A076522 001

Jun 23, 2009

Jan 29, 2004

0.75%

N020531 001

Sep 20, 1995

0.75%
0.75%

A076408 001
A077549 001

May 28, 2004

Dec 19, 2007

1%

N020743 001

Sep 26, 1997

0.75%
1%

N019737 001
N021789 001

Nov 22, 1988

Jun 30, 2005

0.75%
0.75%
0.75%
0.75%
1%

A077018
A078178
A077819
A077547
A090903

Jun
Jan
Jul
Jul
Jul

001
002
003
001
001
002
001
002
003
002
001
001
001
002
003
001
001
001
002
001
002

Sep
Sep
Sep
Jan
Dec
Dec
Jun
Jun
Jun
Jul
Dec
Dec
Jan
Jan
Jan
Mar
Mar
Jan
Jan
May
May

11,
11,
11,
15,
10,
10,
17,
17,
17,
15,
21,
21,
16,
16,
16,
25,
25,
31,
31,
27,
27,

2007
2007
2007
2004
1996
1996
2008
2008
2008
2009
1993
1993
2004
2004
2004
1994
1994
1995
1995
1994
1994

METRONIDAZOLE
CAPSULE; ORAL
FLAGYL
AB + GD SEARLE LLC
METRONIDAZOLE
ALEMBIC LTD
AB
PAR PHARM
AB

AB
AB
AB
XX

AB
AB
AB
AB
AB
AB
AB

CREAM; TOPICAL
METROCREAM
+ GALDERMA LABS LP
METRONIDAZOLE
ALTANA
G AND W LABS
NORITATE
+ SANOFI AVENTIS US
GEL; TOPICAL
METROGEL
+ GALDERMA LABS LP
+
METRONIDAZOLE
ALTANA
G AND W LABS INC
TARO
TOLMAR

001
001
001
001
001

06,
19,
18,
13,
22,

2006
2011
2006
2006
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 289 (of 424)

METRONIDAZOLE
GEL; VAGINAL
METROGEL-VAGINAL
AB + MEDICIS
METRONIDAZOLE
TOLMAR
AB
VANDAZOLE
BX
TEVA PHARMS

AP
AP
AP
AP
AP

0.75%

N020208 001

Aug 17, 1992

0.75%

A077264 001

Oct 31, 2006

0.75%

N021806 001

May 20, 2005

INJECTABLE; INJECTION
FLAGYL I.V. RTU IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
500MG/100ML
+ PFIZER
500MG/100ML
METRO I.V. IN PLASTIC CONTAINER
+ B BRAUN
500MG/100ML
METRONIDAZOLE IN PLASTIC CONTAINER
CLARIS LIFESCIENCES
500MG/100ML
+ HOSPIRA
500MG/100ML

LOTION; TOPICAL
METROLOTION
AB + GALDERMA LABS LP
METRONIDAZOLE
ALTANA
AB
TABLET; ORAL
FLAGYL
GD SEARLE LLC
AB
AB +
METRONIDAZOLE
ALEMBIC PHARMS LTD
AB
AB
MUTUAL PHARM
AB
AB
PLIVA
AB
AB
TEVA
AB
WATSON LABS
AB
AB
AB

N018657 001
N018353 002
N018900 001

Sep 29, 1983

A078084 001
N018890 002

Mar 31, 2008

Nov 18, 1983

0.75%

N020901 001

Nov 24, 1998

0.75%

A077197 001

May 24, 2006

250MG
500MG

N012623 001
N012623 003

250MG
500MG
250MG
500MG
250MG
500MG
500MG
250MG
250MG
500MG

A079067
A079067
A070772
A070773
A070027
A070033
A070044
A070035
N018764
N018764

TABLET, EXTENDED RELEASE; ORAL

FLAGYL ER
AB + GD SEARLE LLC
750MG
METRONIDAZOLE
ALEMBIC LTD
AB
750MG

001
002
001
001
001
001
001
001
001
002

Mar
Mar
Jul
Jul
Nov
Dec
Feb
Dec
Sep
Dec

13,
13,
16,
16,
06,
06,
08,
20,
17,
20,

2009
2009
1986
1986
1984
1984
1985
1984
1982
1982

N020868 001

Nov 26, 1997

A090222 001

May 05, 2010

250MG

N012911 002

Aug 09, 1996

250MG

N017871 001

CAPSULE; ORAL
MEXILETINE HYDROCHLORIDE
TEVA
AB
150MG
AB
200MG
AB +
250MG

A074377 001
A074377 002
A074377 003

METYRAPONE
CAPSULE; ORAL

METOPIRONE

XX + NOVARTIS

METYROSINE
CAPSULE; ORAL

DEMSER

XX + ATON

MEXILETINE HYDROCHLORIDE

May 16, 1995

May 16, 1995
May 16, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 290 (of 424)

MEXILETINE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
MEXILETINE HYDROCHLORIDE
WATSON LABS
150MG
150MG
200MG
200MG
250MG
250MG

A074711
A074865
A074711
A074865
A074711
A074865

001
001
002
002
003
003

Feb
Apr
Feb
Apr
Feb
Apr

26,
13,
26,
13,
26,
13,

1997
1998
1997
1998
1997
1998

MICAFUNGIN SODIUM
INJECTABLE; IV (INFUSION)

MYCAMINE

XX + ASTELLAS
50MG/VIAL
XX +
100MG/VIAL

N021506 002
N021506 003

Mar 16, 2005

Jun 27, 2006

50MG

N022404 001

Apr 16, 2010

200MG

A073508 001

Nov 19, 1993

200MG

N018888 001

Aug 15, 1984

N021026 001

Feb 16, 2006

A075154
A075154
A075243
A075243
A075324
A075324
A075247
A075247
A075421
A075421
A075637
A075637
A075293
A075856
A075293
A075856
A076144
A076144
A076020
A076020
A075494
A075481
A075494

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Oct
Oct
Jun
Jun
Jun
Jun
Jan
Jan
Jul
Jul
Jun
Jun
Jun

MICONAZOLE
TABLET; BUCCAL

ORAVIG

XX + BIOALLIANCE PHARMA

MICONAZOLE NITRATE
SUPPOSITORY; VAGINAL
MICONAZOLE NITRATE
ACTAVIS MID ATLANTIC
AB
MONISTAT 3
AB + INSIGHT PHARMS

MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE

OINTMENT; TOPICAL

VUSION

XX + STIEFEL LABS INC

0.25%;81.35%;15%

MIDAZOLAM HYDROCHLORIDE
INJECTABLE; INJECTION
MIDAZOLAM HYDROCHLORIDE
APP PHARMS
AP
EQ
AP
EQ
BAXTER HLTHCARE
AP
EQ
AP
EQ
BAXTER HLTHCARE CORP EQ
AP
AP
EQ
BEDFORD
AP
EQ
AP
EQ
BEN VENUE
AP
EQ
AP
EQ
CLARIS LIFESCIENCES
AP
EQ
AP
EQ
AP + HOSPIRA
EQ
AP
EQ
AP +
EQ
AP
EQ
INTL MEDICATED
AP
EQ
AP
EQ
INTL MEDICATION
AP
EQ
AP
EQ
TAYLOR
AP
EQ
AP
EQ
AP
EQ

1MG
5MG
1MG
5MG
1MG
5MG
1MG
5MG
1MG
5MG
1MG
5MG
1MG
1MG
5MG
5MG
1MG
5MG
1MG
5MG
1MG
5MG
5MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

002
001
001
002
001
002
002
001
002
001
001
002
001
001
002
002
001
002
001
002
001
001
002

20,
20,
20,
20,
20,
20,
23,
23,
20,
20,
31,
31,
20,
13,
20,
13,
26,
26,
16,
16,
30,
30,
30,

2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2002
2000
2002
2005
2005
2004
2004
2000
2000
2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 291 (of 424)

MIDAZOLAM HYDROCHLORIDE
INJECTABLE; INJECTION
MIDAZOLAM HYDROCHLORIDE
WOCKHARDT
EQ 1MG BASE/ML
AP
EQ 1MG BASE/ML
AP
EQ 5MG BASE/ML
AP
EQ 5MG BASE/ML
AP
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
EQ 1MG BASE/ML
AP + HOSPIRA
EQ 5MG BASE/ML
AP +
SAGENT STRIDES
AP
EQ 1MG BASE/ML
AP
EQ 5MG BASE/ML
MIDOZALAM HYDROCHLORIDE
SAGENT STRIDES
AP
EQ 1MG BASE/ML
AP
EQ 5MG BASE/ML

AA
AA
AA
AA
AA

SYRUP; ORAL
MIDAZOLAM HYDROCHLORIDE
APOTEX INC
HI TECH PHARMA
PADDOCK LLC
RANBAXY
+ ROXANE

EQ
EQ
EQ
EQ
EQ

2MG
2MG
2MG
2MG
2MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

A078141
A078511
A078141
A078511

001
001
002
002

May
Nov
May
Nov

30,
10,
30,
10,

2008
2008
2008
2008

A075857
A075857
A090315
A090315

001
002
001
002

Jul
Jul
Nov
Nov

22,
22,
29,
29,

2002
2002
2010
2010

A090316 001
A090316 002

May 04, 2011

May 04, 2011

A077115
A075958
A076379
A076058
A075873

001
001
001
001
001

Sep
Sep
May
Mar
Apr

09,
04,
02,
15,
30,

2005
2003
2005
2002
2002

A077746
A077746
A077746
A076449
A076449
A076449
A076577
A076577
A076577
A076514
A076514
A076514

001
002
003
001
002
003
001
002
003
001
002
003

Sep
Sep
Sep
May
May
Dec
Sep
Sep
Sep
Sep
Sep
Jul

12,
12,
12,
27,
27,
16,
10,
10,
10,
11,
11,
02,

2006
2006
2006
2004
2004
2005
2003
2003
2003
2003
2003
2004

MIDODRINE HYDROCHLORIDE
TABLET; ORAL
MIDODRINE HYDROCHLORIDE
APOTEX INC
2.5MG
AB
5MG
AB
10MG
AB
IMPAX PHARMS
2.5MG
AB
5MG
AB
10MG
AB
MYLAN
2.5MG
AB
5MG
AB
10MG
AB
SANDOZ
2.5MG
AB
5MG
AB
10MG
AB
ORVATEN
UPSHER SMITH
AB
2.5MG
AB
5MG
AB
10MG
PROAMATINE
SHIRE
AB
2.5MG
AB +
5MG
AB
10MG

A076725 001
A076725 002
A076725 003

Nov 03, 2004

Nov 03, 2004
Nov 03, 2004

N019815 001
N019815 002
N019815 003

Sep 06, 1996

Sep 06, 1996
Mar 20, 2002

200MG

N020687 001

Sep 28, 2000

25MG
50MG
100MG

N020682 001
N020682 002
N020682 003

Dec 18, 1996

Dec 18, 1996
Dec 18, 1996

MIFEPRISTONE
TABLET; ORAL

MIFEPREX

XX + DANCO LABS LLC

MIGLITOL
TABLET; ORAL
GLYSET
XX
PHARMACIA AND UPJOHN
XX
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 292 (of 424)

MIGLUSTAT
CAPSULE; ORAL

ZAVESCA

XX + ACTELION PHARMS LTD

100MG

N021348 001

Jul 31, 2003

12.5MG
25MG
50MG
100MG

N022256
N022256
N022256
N022256

001
002
003
004

Jan
Jan
Jan
Jan

14,
14,
14,
14,

2009
2009
2009
2009

A075936
A075530
A075660
A076427
A077190
A077966
A076013

001
001
001
001
001
001
001

May
May
May
Sep
Oct
Dec
Aug

28,
28,
28,
21,
31,
03,
02,

2002
2002
2002
2004
2006
2010
2002

MILNACIPRAN HYDROCHLORIDE
TABLET; ORAL
SAVELLA
CYPRESS BIOSCIENCE
XX
XX
XX +
XX

MILRINONE LACTATE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
MILRINONE LACTATE
APP PHARMS
EQ 1MG BASE/ML
BAXTER HLTHCARE
EQ 1MG BASE/ML
+ BEDFORD
EQ 1MG BASE/ML
CLARIS LIFESCIENCES
EQ 1MG BASE/ML
GLAND PHARMA LTD
EQ 1MG BASE/ML
HIKMA FARMACEUTICA
EQ 1MG BASE/ML
INTL MEDICATED
EQ 1MG BASE/ML
MILRINONE LACTATE IN DEXTROSE 5%
CLARIS LIFESCIENCES
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
+ BAXTER HLTHCARE
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
+
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
BEDFORD LABS
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
CLARIS LIFESCIENCES
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
HOSPIRA
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
MILRINONE LACTATE IN PLASTIC CONTAINER
HIKMA FARMACEUTICA
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

A077151 002

Jul 20, 2005

A076414
A075834
A075834
A078113
A078113
A077151
A075885
A075885

Aug
May
May
May
May
Jul
May
May

001
001
002
001
002
001
001
002

18,
28,
28,
21,
21,
20,
28,
28,

2004
2002
2002
2008
2008
2005
2002
2002

A090038 001
A090038 002

Jan 21, 2010

Jan 21, 2010

75MG BASE
100MG BASE

A063067 002
A063067 001

Sep 15, 1999

Jul 31, 1990

50MG BASE
100MG BASE

N050649 001
N050649 002

May 31, 1990

May 31, 1990

50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE
50MG BASE

A065470
A065470
A065470
A065005
A065005
A065005
A065062
A065062
A065062
A063011
A063009
A063009
A063181

Mar
Mar
Mar
Mar
Apr
Mar
Nov
Nov
Nov
Mar
Aug
Mar
Dec

MINOCYCLINE HYDROCHLORIDE
CAPSULE; ORAL
DYNACIN
MEDICIS
AB
EQ
AB
EQ
MINOCIN
TRIAX PHARMS LLC
AB
EQ
AB
EQ
MINOCYCLINE HYDROCHLORIDE
AUROBINDO PHARMA
AB
EQ
AB
EQ
AB
EQ
IMPAX LABS
AB
EQ
AB
EQ
AB
EQ
RANBAXY
AB
EQ
AB
EQ
AB
EQ
TEVA
AB
EQ
AB
EQ
AB +
EQ
WATSON LABS
AB
EQ

001
002
003
001
003
002
001
002
003
001
002
001
001

11,
11,
11,
23,
18,
23,
30,
30,
30,
02,
12,
02,
30,

2008
2008
2008
1999
2001
1999
2000
2000
2000
1992
2003
1992
1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 293 (of 424)

MINOCYCLINE HYDROCHLORIDE
CAPSULE; ORAL
MINOCYCLINE HYDROCHLORIDE
WATSON LABS
AB
EQ 75MG BASE
AB
EQ 100MG BASE

A063065 002
A063065 001

INJECTABLE; INJECTION

MINOCIN

XX + TRIAX PHARMS LLC

N050444 001

EQ 100MG BASE/VIAL

Jun 10, 1999

Dec 30, 1991

POWDER, EXTENDED RELEASE; DENTAL

ARESTIN

EQ 1MG BASE
XX + ORAPHARMA

N050781 001

Feb 16, 2001

TABLET; ORAL
MINOCYCLINE HYDROCHLORIDE
DR REDDYS LABS LTD
AB
EQ
AB
EQ
AB
EQ
PAR PHARM
AB
EQ
AB
EQ
AB +
EQ
RANBAXY
AB
EQ
AB
EQ
AB
EQ

A065436
A065436
A065436
A065131
A065131
A065131
A065156
A065156
A065156

001
002
003
001
002
003
001
002
003

Dec
Dec
Dec
Apr
Apr
Apr
Jan
Jan
Jan

26,
26,
26,
16,
16,
16,
06,
06,
06,

2007
2007
2007
2003
2003
2003
2004
2004
2004

A065485
A065485
A065485
A090024
A090024
A090024
A091424
A091424
A091424
A090911
A090911
A090911
A090422
A090422
A090422

001
002
003
001
002
003
001
003
004
001
002
003
001
002
003

Mar
Mar
Mar
Feb
Feb
Feb
Nov
Nov
Nov
Jul
Jul
Jul
Aug
Aug
Aug

17,
17,
17,
03,
03,
03,
30,
30,
30,
20,
20,
20,
13,
13,
13,

2009
2009
2009
2009
2009
2009
2011
2011
2011
2010
2010
2010
2009
2009
2009

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
XX
XX
XX
XX
XX

50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE

TABLET, EXTENDED RELEASE; ORAL

MINOCYCLINE HYDROCHLORIDE
BARR
EQ 45MG BASE
EQ 90MG BASE
EQ 135MG BASE
IMPAX LABS INC
EQ 45MG BASE
EQ 90MG BASE
EQ 135MG BASE
LUPIN LTD
EQ 45MG BASE
EQ 90MG BASE
EQ 135MG BASE
MATRIX LABS LTD
EQ 45MG BASE
EQ 90MG BASE
EQ 135MG BASE
SANDOZ
EQ 45MG BASE
EQ 90MG BASE
EQ 135MG BASE
SOLODYN
MEDICIS
EQ 45MG BASE
EQ 90MG BASE
+
EQ 135MG BASE
SOLODYN
MEDICIS
EQ 55MG BASE
EQ 65MG BASE
EQ 80MG BASE
EQ 105MG BASE
EQ 115MG BASE

N050808 001
N050808 002
N050808 003

May 08, 2006

May 08, 2006
May 08, 2006

N050808
N050808
N050808
N050808
N050808

008
004
007
006
005

Aug
Jul
Aug
Aug
Jul

27,
23,
27,
27,
23,

2010
2009
2010
2010
2009

A072708
A072709
A071826
A071839
A071344
A071345

001
001
001
001
001
001

Dec
Dec
Nov
Nov
Mar
Mar

14,
14,
14,
14,
03,
03,

1995
1995
1988
1988
1987
1987

MINOXIDIL
TABLET; ORAL
MINOXIDIL
MUTUAL PHARM
AB
AB
PAR PHARM
AB
AB
WATSON LABS
AB
AB +

2.5MG
10MG
2.5MG
10MG
2.5MG
10MG

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PRESCRIPTION DRUG PRODUCT LIST

3 - 294 (of 424)

MIRTAZAPINE
TABLET; ORAL
MIRTAZAPINE
ALPHAPHARM
AB
AB
AB
APOTEX INC
AB
AB
AB
AUROBINDO
AB
AB
AB
AB
CARACO
AB
AB
AB
AB
MYLAN
AB
AB
AB
SANDOZ
AB
AB
AB
TEVA
AB
AB
AB
WATSON LABS
AB
AB
AB
WATSON LABS FLORIDA
AB
AB
AB
REMERON
AB + ORGANON USA INC
AB
AB

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

19,
19,
19,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
19,
19,
19,
19,
19,
19,
24,
24,
19,
19,
19,
19,
20,
20,
20,

2003
2003
2003
2007
2007
2007
2004
2004
2004
2004
2004
2004
2004
2004
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003

A076176
A076176
A076176
A077666
A077666
A077666
A076921
A076921
A076921
A076921
A076541
A076541
A076541
A076541
A076122
A076122
A076122
A076219
A076219
A076219
A076119
A076119
A076119
A076312
A076312
A076312
A076336
A076336
A076336

15MG
30MG
45MG

N020415 001
N020415 002
N020415 003

Jun 14, 1996

Jun 14, 1996
Mar 17, 1997

A077959
A077959
A077959
A077376
A077376
A077376
A076901
A076901
A076901
A076307
A076307
A076307

Feb
Feb
Feb
Dec
Dec
Feb
Jun
Jun
Jun
Dec
Dec
Feb

TABLET, ORALLY DISINTEGRATING; ORAL

MIRTAZAPINE
ACTAVIS ELIZABETH
15MG
30MG
45MG
AUROBINDO PHARMA LTD 15MG
30MG
45MG
TEVA
15MG
30MG
45MG
WATSON LABS
15MG
30MG
45MG
REMERON SOLTAB
+ ORGANON USA INC
15MG
30MG
45MG

001
002
003
001
002
003
001
002
003
004
004
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jun
Jun
Jun
Aug
Aug
Aug
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Jun
Jun
Jan
Jan
Jun
Jun
Jun
Jun
Jun
Jun
Jun

15MG
30MG
45MG
15MG
30MG
45MG
7.5MG
15MG
30MG
45MG
7.5MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG
15MG
30MG
45MG

001
002
003
002
003
004
001
002
003
001
002
003

14,
14,
14,
08,
08,
28,
28,
28,
28,
17,
17,
28,

2011
2011
2011
2005
2005
2006
2005
2005
2005
2003
2003
2006

N021208 001
N021208 002
N021208 003

Jan 12, 2001

Jan 12, 2001
Jan 12, 2001

N019268 003
N019268 001

Sep 21, 1990

Dec 27, 1988

MISOPROSTOL
TABLET; ORAL
CYTOTEC
GD SEARLE LLC
AB
AB +

0.1MG
0.2MG

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PRESCRIPTION DRUG PRODUCT LIST

3 - 295 (of 424)

MISOPROSTOL
TABLET; ORAL
MISOPROSTOL
IVAX SUB TEVA PHARMS
AB
AB

0.1MG
0.2MG

A076095 001
A076095 002

Jul 10, 2002

Jul 10, 2002

5MG/VIAL
20MG/VIAL
40MG/VIAL
5MG/VIAL
20MG/VIAL
5MG/VIAL
20MG/VIAL

A064144
A064144
A064144
A064180
A064180
A064117
A064117

Apr
Apr
Aug
Dec
Dec
Apr
Apr

30,
30,
11,
23,
23,
19,
19,

1998
1998
2009
1999
1999
1995
1995

500MG

N016885 001

Apr
Apr
Apr
Apr
Apr
Apr
May
May
May
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

11,
11,
11,
11,
11,
11,
14,
14,
14,
11,
11,
11,
13,
13,
11,
11,
11,

2006
2006
2006
2006
2006
2006
2008
2008
2008
2006
2006
2006
2009
2009
2006
2006
2006

MITOMYCIN

AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
MITOMYCIN
+ ACCORD HLTHCARE
+
+
BAXTER HLTHCARE
BEDFORD

001
002
003
001
002
001
002

MITOTANE
TABLET; ORAL

LYSODREN

XX + BRISTOL MYERS SQUIBB

MITOXANTRONE HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
MITOXANTRONE HYDROCHLORIDE
APP PHARMS
EQ
EQ
EQ
BEDFORD
EQ
EQ
EQ
FRESENIUS KABI ONCOL EQ
EQ
EQ
+ HOSPIRA
EQ
+
EQ
+
EQ
MYLAN INSTITUTIONAL
EQ
EQ
TEVA PARENTERAL
EQ
EQ
EQ

20MG
25MG
30MG
20MG
25MG
30MG
20MG
25MG
30MG
20MG
25MG
30MG
20MG
30MG
20MG
25MG
30MG

BASE/10ML (EQ 2MG BASE/ML)

BASE/12.5ML (EQ 2MG BASE/ML)
BASE/15ML (EQ 2MG BASE/ML)
BASE/10ML (EQ 2MG BASE/ML)
BASE/12.5ML (EQ 2MG BASE/ML)
BASE/15ML (EQ 2MG BASE/ML)
BASE/10ML (EQ 2MG BASE/ML)
BASE/12.5ML (EQ 2MG BASE/ML)
BASE/15ML (EQ 2MG BASE/ML)
BASE/10ML (EQ 2MG BASE/ML)
BASE/12.5ML (EQ 2MG BASE/ML)
BASE/15ML (EQ 2MG BASE/ML)
BASE/10ML (EQ 2MG BASE/ML)
BASE/15ML (EQ 2MG BASE/ML)
BASE/10ML (EQ 2MG BASE/ML)
BASE/12.5ML (EQ 2MG BASE/ML)
BASE/15ML (EQ 2MG BASE/ML)

A077496
A077496
A077496
A076611
A076611
A076611
A078606
A078606
A078606
A076871
A076871
A076871
A078980
A078980
A077356
A077356
A077356

001
002
003
001
002
003
001
002
003
001
002
003
001
002
001
002
003

MODAFINIL
TABLET; ORAL
PROVIGIL
CEPHALON
XX
XX +

100MG
200MG

N020717 001
N020717 002

Dec 24, 1998

Dec 24, 1998

A078454
A078454
A090416
A090416
A077536
A077536
A076204

Jun
Jun
Mar
Mar
Nov
Nov
May

MOEXIPRIL HYDROCHLORIDE
TABLET; ORAL
MOEXIPRIL HYDROCHLORIDE
APOTEX INC
AB
7.5MG
AB
15MG
GLENMARK GENERICS
AB
7.5MG
AB
15MG
PADDOCK LLC
AB
7.5MG
AB
15MG
TEVA
AB
7.5MG

001
002
001
002
001
002
001

02,
02,
30,
30,
30,
30,
08,

2008
2008
2010
2010
2006
2006
2003

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PRESCRIPTION DRUG PRODUCT LIST

3 - 296 (of 424)

MOEXIPRIL HYDROCHLORIDE
TABLET; ORAL
MOEXIPRIL HYDROCHLORIDE
TEVA
AB
15MG
UNIVASC
UCB INC
AB
7.5MG
AB +
15MG

A076204 002

May 08, 2003

N020312 001
N020312 002

Apr 19, 1995

Apr 19, 1995

0.1%

N019625 001

May 06, 1987

0.1%
0.1%
0.1%
0.1%
0.1%

A076171
A077447
A078541
A076679
A076591

Apr
May
May
Dec
Apr

0.1%

N019796 001

Mar 30, 1989

0.1%
0.1%
0.1%
0.1%
0.1%
0.1%

A077678
A090506
A075919
A077180
A076788
A076499

Nov
Aug
Nov
Apr
Mar
Nov

0.1%

N019543 001

Apr 30, 1987

0.1%
0.1%
0.1%
0.1%
0.1%
0.1%

A077061
A077401
A078571
A076067
A076624
A076481

Mar
Jun
May
Mar
Dec
Nov

0.11MG/INH
0.22MG/INH

N021067 002
N021067 001

Feb 01, 2008

Mar 30, 2005

EQ 0.05MG BASE/SPRAY

N020762 001

Oct 01, 1997

GRANULE; ORAL

SINGULAIR

XX + MERCK

EQ 4MG BASE/PACKET

N021409 001

Jul 26, 2002

TABLET; ORAL

SINGULAIR

XX + MERCK

EQ 10MG BASE

N020829 002

Feb 20, 1998

TABLET, CHEWABLE; ORAL

SINGULAIR
MERCK
XX
XX +

EQ 4MG BASE
EQ 5MG BASE

N020830 002
N020830 001

Mar 03, 2000

Feb 20, 1998

MOMETASONE FUROATE

AB
AB
AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
AB

CREAM; TOPICAL
ELOCON
+ SCHERING
MOMETASONE FUROATE
ALTANA
G AND W LABS
GLENMARK GENERICS
TARO
TOLMAR
LOTION; TOPICAL
ELOCON
+ SCHERING
MOMETASONE FUROATE
G AND W LABS
GLENMARK GENERICS
NYCOMED US
PERRIGO
TARO
TOLMAR
OINTMENT; TOPICAL
ELOCON
+ SCHERING
MOMETASONE FUROATE
ALTANA
G AND W LABS
GLENMARK GENERICS
PERRIGO NEW YORK
TARO
TOLMAR

POWDER; INHALATION
ASMANEX TWISTHALER
SCHERING
XX
XX +

001
001
001
001
001

001
001
001
001
001
001

001
001
001
001
001
001

08,
22,
28,
21,
18,

21,
09,
29,
06,
15,
21,

28,
20,
28,
18,
03,
14,

2005
2006
2008
2004
2007

2007
2010
2007
2005
2006
2007

2005
2006
2008
2002
2004
2003

MOMETASONE FUROATE MONOHYDRATE

SPRAY, METERED; NASAL

NASONEX

XX + SCHERING PLOUGH

MONTELUKAST SODIUM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 297 (of 424)

MORPHINE SULFATE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
BX
BX
XX
XX
XX
XX
XX
XX

CAPSULE, EXTENDED RELEASE; ORAL

KADIAN
ACTAVIS ELIZABETH
20MG
30MG
50MG
60MG
80MG
+
100MG
MORPHINE SULFATE
WATSON LABS
20MG
30MG
50MG
60MG
80MG
100MG
AVINZA
KING PHARMS
30MG
60MG
AVINZA
KING PHARMS
45MG
75MG
90MG
+
120MG
KADIAN
+ ACTAVIS ELIZABETH
10MG
+
200MG

INJECTABLE; INJECTION
ASTRAMORPH PF
APP PHARMS
AP
AP
AP
AP
DURAMORPH PF
AP + BAXTER HLTHCARE
AP +
MORPHINE SULFATE
HOSPIRA
AP
AP
AP
AP
AP +
WATSON LABS
AP
AP
AP
AP
INFUMORPH
XX + BAXTER HLTHCARE
XX +
MORPHINE SULFATE
XX + HOSPIRA
XX + HOSPIRA INC
XX +
XX +
XX +
XX +
XX + MERIDIAN MEDCL TECHN

N020616
N020616
N020616
N020616
N020616
N020616

001
004
002
005
006
003

Jul
Mar
Jul
Mar
Oct
Jul

03,
09,
03,
09,
27,
03,

1996
2001
1996
2001
2006
1996

A200812
A200812
A200812
A200812
A200812
A200812

001
002
003
004
005
006

Nov
Nov
Nov
Nov
Nov
Nov

10,
10,
10,
10,
10,
10,

2011
2011
2011
2011
2011
2011

N021260 001
N021260 002

Mar 20, 2002

Mar 20, 2002

N021260
N021260
N021260
N021260

Dec
Dec
Mar
Mar

005
006
003
004

18,
18,
20,
20,

2008
2008
2002
2002

N020616 008
N020616 007

Apr 20, 2007

Feb 27, 2007

0.5MG/ML
0.5MG/ML
1MG/ML
1MG/ML

A071050
A071051
A071052
A071053

Oct
Oct
Oct
Oct

0.5MG/ML
1MG/ML

N018565 001
N018565 002

Sep 18, 1984

Sep 18, 1984

0.5MG/ML
0.5MG/ML
1MG/ML
1MG/ML
1MG/ML
0.5MG/ML
0.5MG/ML
1MG/ML
1MG/ML

A071849
A073509
A071850
A073510
N019916
A073373
A073375
A073374
A073376

May
Sep
May
Sep
Oct
Sep
Sep
Sep
Sep

10MG/ML
25MG/ML

N018565 003
N018565 004

Jul 19, 1991

Jul 19, 1991

5MG/ML
2MG/ML
4MG/ML
8MG/ML
10MG/ML
15MG/ML
15MG/ML

N019916
N202515
N202515
N202515
N202515
N202515
N019999

Oct
Nov
Nov
Nov
Nov
Nov
Jul

INJECTABLE, LIPOSOMAL; EPIDURAL

DEPODUR
10MG/ML (10MG/ML)
XX + EKR THERAP

001
001
001
001

001
001
001
001
001
001
001
001
001

002
001
002
003
004
005
001

N021671 001

07,
07,
07,
07,

11,
30,
11,
30,
30,
30,
30,
30,
30,

27,
14,
14,
14,
14,
14,
12,

1986
1986
1986
1986

1988
1992
1988
1992
1992
1991
1991
1991
1991

2006
2011
2011
2011
2011
2011
1990

May 18, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 298 (of 424)

MORPHINE SULFATE
SOLUTION; ORAL
MORPHINE SULFATE
MALLINCKRODT INC
AA
ROXANE
AA
AA
AA +
VISTAPHARM
AA
AA
MORPHINE SULFATE
LANNETT HOLDINGS INC
XX

100MG/5ML
10MG/5ML
20MG/5ML
100MG/5ML
10MG/5ML
20MG/5ML

A202348
N022195
N022195
N022195
A201947
A201947

20MG/ML

N201517 001

Jun 23, 2011

TABLET; ORAL
MORPHINE SULFATE
ROXANE
XX
XX +

15MG
30MG

N022207 001
N022207 002

Mar 17, 2008

Mar 17, 2008

A075407
A075295
A075295
A075295
A075295
A075295
A076412
A076412
A076412
A076438
A076438
A200824
A200824
A200824
A200824
A200824
A076733
A076720
A076720
A077855
A077855
A074862
A074862
A074862
A074769
A074769

001
001
002
003
004
005
001
002
003
001
002
001
002
003
004
005
001
002
001
001
002
001
002
003
001
002

Jan
Oct
Oct
Oct
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Oct
Oct
Oct
Oct
Oct
May
Dec
May
Sep
Sep
Jul
Jul
Jul
Jul
Jul

28,
28,
28,
28,
15,
15,
31,
31,
31,
03,
03,
18,
18,
18,
18,
18,
19,
23,
19,
27,
27,
07,
07,
07,
02,
02,

2000
1998
1998
1998
2000
2000
2003
2003
2003
2003
2003
2011
2011
2011
2011
2011
2004
2005
2004
2007
2007
1998
1998
1998
1998
1998

N019516
N019516
N019516
N019516
N019516

003
001
002
004
005

Sep
May
Apr
Jan
Nov

12,
29,
08,
16,
08,

1989
1987
1988
1990
1993

N019977
N019977
N019977
N019977

004
001
002
003

Nov
Aug
Aug
Aug

23,
15,
15,
15,

1994
1991
1991
1991

TABLET, EXTENDED RELEASE; ORAL

MORPHINE SULFATE
CLONMEL HLTHCARE
AB
15MG
ENDO PHARMS
AB
15MG
AB
30MG
AB
60MG
AB
100MG
AB
200MG
MALLINCKRODT
AB
15MG
AB
30MG
AB
60MG
AB
100MG
AB
200MG
MYLAN PHARMS INC
AB
15MG
AB
30MG
AB
60MG
AB
100MG
AB
200MG
NESHER PHARMS
AB
15MG
AB
30MG
AB
60MG
AB
100MG
AB
200MG
RHODES PHARMS
AB
15MG
AB
30MG
AB
60MG
AB
100MG
AB
200MG
MS CONTIN
PURDUE PHARMA LP
AB
15MG
AB
30MG
AB
60MG
AB +
100MG
AB
200MG
ORAMORPH SR
BC
XANODYNE PHARM
15MG
BC
30MG
BC
60MG
BC +
100MG

001
001
002
003
001
002

Jul
Mar
Mar
Jan
Jan
Jan

15,
17,
17,
25,
05,
05,

2011
2008
2008
2010
2012
2012

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL

EMBEDA

ALPHARMA KING
20MG;0.8MG
XX
30MG;1.2MG
XX

N022321 001
N022321 002

Aug 13, 2009

Aug 13, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 299 (of 424)

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL
EMBEDA
ALPHARMA KING
50MG;2MG
XX
60MG;2.4MG
XX
80MG;3.2MG
XX
100MG;4MG
XX +

N022321
N022321
N022321
N022321

003
004
005
006

Aug
Aug
Aug
Aug

13,
13,
13,
13,

2009
2009
2009
2009

MOXIFLOXACIN HYDROCHLORIDE
INJECTABLE; IV (INFUSION)

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

160MG/100ML
XX + BAYER HLTHCARE

N021277 001

Nov 30, 2001

N022428 001

Nov 19, 2010

N021598 001

Apr 15, 2003

EQ 400MG BASE

N021085 001

Dec 10, 1999

2%

N050591 001

Dec 31, 1987

2%
2%
2%
2%
2%

A065192
A090480
A065123
A065170
A065085

Nov
Jun
Nov
Sep
Nov

2%

N050788 001

Dec 04, 2002

CREAM; TOPICAL

BACTROBAN

XX + GLAXOSMITHKLINE

EQ 2% BASE

N050746 001

Dec 11, 1997

OINTMENT; NASAL

BACTROBAN

XX + GLAXOSMITHKLINE

EQ 2% BASE

N050703 001

Sep 18, 1995

250MG

N050722 001

May 03, 1995

250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG

A090253
A090419
A091315
A090111
A065520
A065410
A065379
A090055
A065491
A065433

May
Apr
Oct
Dec
May
Jul
Oct
Jun
May
May

SOLUTION/DROPS; OPHTHALMIC

MOXEZA

XX + ALCON PHARMS LTD

EQ 0.5% BASE
VIGAMOX
EQ 0.5% BASE
XX + ALCON PHARMS LTD
TABLET; ORAL

AVELOX

XX + BAYER HLTHCARE

MUPIROCIN

AB
AB
AB
AB
AB
AB
BX

OINTMENT; TOPICAL
BACTROBAN
+ GLAXOSMITHKLINE
MUPIROCIN
ALTANA
GLENMARK PHARMS
PERRIGO NEW YORK
TARO
TEVA
CENTANY
PERRIGO NEW YORK

001
001
001
001
001

30,
08,
07,
23,
07,

2005
2011
2003
2005
2003

MUPIROCIN CALCIUM

MYCOPHENOLATE MOFETIL

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
CELLCEPT
+ ROCHE PALO
MYCOPHENOLATE MOFETIL
ACCORD HLTHCARE INC
APOTEX CORP
DR REDDYS LABS LTD
ENDO PHARMS
MYLAN
ROXANE
SANDOZ
STRIDES ARCOLAB LTD
TEVA PHARMS
ZYDUS PHARMS USA INC

001
001
001
001
001
001
001
001
001
001

04,
22,
27,
22,
04,
29,
15,
10,
06,
04,

2009
2009
2011
2009
2009
2008
2008
2010
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 300 (of 424)

MYCOPHENOLATE MOFETIL
SUSPENSION; ORAL

CELLCEPT

XX + ROCHE PALO

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
CELLCEPT
+ ROCHE PALO
MYCOPHENOLATE MOFETIL
ACCORD HLTHCARE
ALKEM LABS LTD
APOTEX
ENDO PHARMS
MYLAN
ROXANE
SANDOZ
STRIDES ARCOLAB LTD
TEVA PHARMS
ZYDUS PHARMS USA INC

200MG/ML

N050759 001

Oct 01, 1998

500MG

N050723 001

Jun 19, 1997

500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG

A065416
A091249
A090499
A090606
A065521
A065413
A065451
A090456
A065457
A065477

May
Nov
Apr
Jul
May
Jul
Oct
Jun
May
May

001
001
001
001
001
001
001
001
001
001

04,
04,
22,
16,
04,
29,
15,
10,
04,
04,

2009
2011
2009
2010
2009
2008
2008
2010
2009
2009

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

INJECTABLE; INJECTION

CELLCEPT

XX + ROCHE PALO

500MG/VIAL

N050758 001

Aug 12, 1998

N050791 001
N050791 002

Feb 27, 2004

Feb 27, 2004

1MG

N018677 001

Dec 26, 1985

500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG

A090427
A090427
A078420
A078420
A078671
A078671
A090445
A090445
A090516
A090516
A076009
A076009
A075280
A075280
A075189
A075189
A091083
A091083

Dec
Dec
Sep
Sep
Mar
Mar
Jan
Jan
Jul
Jul
Jan
Jan
Feb
Feb
May
Sep
Jun
Jun

MYCOPHENOLIC ACID
TABLET, DELAYED RELEASE; ORAL
MYFORTIC
NOVARTIS
180MG
XX
360MG
XX +

NABILONE
CAPSULE; ORAL

CESAMET

XX + MEDA PHARMS

NABUMETONE
TABLET; ORAL
NABUMETONE
APOTEX INC
AB
AB
DR REDDYS LABS LTD
AB
AB
INVAGEN PHARMS
AB
AB
LUPIN LTD
AB
AB
MATRIX LABS LTD
AB
AB
PAR PHARM
AB
AB
SANDOZ
AB
AB
TEVA
AB
AB +
WATSON LABS
AB
AB

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

30,
30,
24,
24,
07,
07,
12,
12,
12,
12,
24,
24,
25,
25,
26,
24,
13,
13,

2011
2011
2008
2008
2008
2008
2011
2011
2010
2010
2003
2003
2002
2002
2000
2001
2011
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 301 (of 424)

NADOLOL
TABLET; ORAL
CORGARD
KING PHARMS
AB
AB
AB +
NADOLOL
IVAX SUB TEVA PHARMS
AB
AB
AB
MYLAN
AB
AB
AB
SANDOZ
AB
AB
AB

20MG
40MG
80MG

N018063 005
N018063 001
N018063 002

Oct 28, 1986

20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG

A074229
A074229
A074255
A074172
A074172
A074172
A074501
A074501
A074501

Aug
Aug
Jan
Oct
Oct
Oct
Nov
Nov
Nov

EQ 0.2MG BASE/SPRAY

N019886 001

Feb 13, 1990

A090560
A090560
A090002
A090002
A090005
A062527
A062732
A062527
A062732
A062527

Oct
Oct
Jun
Jun
Apr
Aug
Dec
Aug
Dec
Aug

001
002
001
001
002
003
001
002
003

30,
30,
24,
31,
31,
31,
09,
09,
09,

1996
1996
1996
1993
1993
1993
1995
1995
1995

NAFARELIN ACETATE
SPRAY, METERED; NASAL

SYNAREL

XX + GD SEARLE LLC

NAFCILLIN SODIUM
INJECTABLE; INJECTION
NAFCILLIN SODIUM
ACIC FINE CHEMS
AP
EQ 1GM BASE
AP
EQ 2GM BASE
IBI
AP
EQ 1GM BASE/VIAL
AP
EQ 2GM BASE/VIAL
INSTITUTO BIOCHEMICO EQ 10GM BASE/VIAL
AP
AP + SANDOZ
EQ 1GM BASE/VIAL
AP +
EQ 1GM BASE/VIAL
AP +
EQ 2GM BASE/VIAL
AP +
EQ 2GM BASE/VIAL
AP +
EQ 10GM BASE/VIAL
NALLPEN IN PLASTIC CONTAINER
EQ 20MG BASE/ML
XX + BAXTER HLTHCARE
EQ 2GM BASE/100ML
XX +

001
002
001
002
001
002
001
003
002
004

03,
03,
30,
30,
20,
02,
23,
02,
23,
02,

2011
2011
2011
2011
2011
1984
1986
1984
1986
1984

N050655 001
N050655 002

Oct 31, 1989

Oct 31, 1989

NAFTIFINE HYDROCHLORIDE
CREAM; TOPICAL

NAFTIN

XX + MERZ PHARMS

1%

N019599 001

Feb 29, 1988

GEL; TOPICAL

NAFTIN

XX + MERZ PHARMS

1%

N019356 001

Jun 18, 1990

A070914
A070915
A070916
A070918

Feb
Feb
Feb
Feb

NALBUPHINE HYDROCHLORIDE

AP
AP
AP
AP

INJECTABLE; INJECTION
NALBUPHINE HYDROCHLORIDE
+ HOSPIRA
10MG/ML
+
10MG/ML
+
20MG/ML
+
20MG/ML

001
001
001
001

03,
03,
03,
03,

1989
1989
1989
1989

NALOXONE HYDROCHLORIDE
INJECTABLE; INJECTION
NALOXONE HYDROCHLORIDE
AP + HOSPIRA

0.4MG/ML

A070172 001

Sep 24, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 302 (of 424)

NALOXONE HYDROCHLORIDE

AP
AP
AP
AP
AP

INJECTABLE; INJECTION

NALOXONE HYDROCHLORIDE
+ HOSPIRA
+
+
INTL MEDICATION
+

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

A070254
A070256
A070257
A070639
A072076

001
001
001
001
001

Jan
Jan
Jan
Sep
Mar

07,
07,
07,
24,
24,

1987
1987
1987
1986
1988

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

TABLET; ORAL
PENTAZOCINE AND NALOXONE HYDROCHLORIDE
GAVIS PHARMS
AB
EQ 0.5MG BASE;EQ 50MG BASE
PENTAZOCINE AND NALOXONE HYDROCHLORIDES
RANBAXY
AB
EQ 0.5MG BASE;EQ 50MG BASE
AB + WATSON LABS
EQ 0.5MG BASE;EQ 50MG BASE

A075735 001

Jul 11, 2001

A075523 001
A074736 001

Mar 17, 2000

Jan 21, 1997

N021897 001

Apr 13, 2006

A091205
A074918
A075274
A076264
A075434

Aug
May
May
Mar
Mar

NALTREXONE
FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR

VIVITROL

380MG/VIAL
XX + ALKERMES

NALTREXONE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
XX
XX

TABLET; ORAL
NALTREXONE HYDROCHLORIDE
ACCORD HLTHCARE
50MG
BARR
50MG
ELITE LABS
50MG
MALLINCKRODT
50MG
SANDOZ
50MG
REVIA
+ DURAMED
50MG
NALTREXONE HYDROCHLORIDE
MALLINCKRODT
25MG
100MG

001
001
001
002
001

17,
08,
26,
22,
08,

2011
1998
1999
2002
2000

N018932 001

Nov 20, 1984

A076264 001
A076264 003

Mar 22, 2002

Mar 22, 2002

A091252 001

Aug 30, 2010

NANDROLONE DECANOATE
INJECTABLE; INJECTION

NANDROLONE DECANOATE

XX + PHARMAFORCE

200MG/ML

NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
ALBALON
AT + ALLERGAN
0.1%
NAPHAZOLINE HYDROCHLORIDE
TAYLOR
AT
0.1%

A080248 001
A083590 001

NAPROXEN
SUSPENSION; ORAL
NAPROSYN
AB + ROCHE PALO
NAPROXEN
ROXANE
AB

25MG/ML

N018965 001

Mar 23, 1987

25MG/ML

A074190 001

Mar 30, 1994

TABLET; ORAL
NAPROSYN
ROCHE PALO
AB
AB
AB +

250MG
375MG
500MG

N017581 002
N017581 003
N017581 004

Apr 15, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 303 (of 424)

NAPROXEN
TABLET; ORAL
NAPROXEN
AMNEAL PHARMS NY
AB
AB
AB
AUROBINDO PHARMA USA
AB
AB
AB
DAVA PHARMS INC
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
MARKSANS PHARMA
AB
AB
AB
MYLAN
AB
AB
AB
PERRIGO R AND D
AB
AB
AB
SANDOZ
AB
AB
AB
TEVA
AB
AB
AB
WATSON LABS
AB
AB
AB
WESTWARD
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB

250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
375MG
500MG

TABLET, DELAYED RELEASE; ORAL

EC-NAPROSYN
AB + ROCHE PALO
375MG
AB +
500MG
NAPROXEN
ALPHAPHARM
AB
375MG
AB
500MG
INVAGEN PHARMS
AB
375MG
AB
500MG
PLIVA
AB
375MG
AB
500MG
SANDOZ
AB
375MG
AB
500MG
TEVA
AB
375MG
AB
500MG

A075927
A075927
A075927
A200429
A200429
A200429
A074410
A074410
A074410
A078250
A078250
A078250
A091305
A091305
A091305
A091416
A091416
A091416
A074121
A074121
A074121
A077339
A077339
A077339
A074140
A074140
A074140
A074201
A074201
A074201
A074457
A074457
A074457
A076494
A076494
A076494
A078620
A078620
A078620

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Dec
Dec
Dec
Nov
Nov
Nov
Apr
Apr
Apr
Mar
Mar
Mar
Aug
Aug
Aug
Feb
Feb
Feb
Dec
Dec
Dec
Apr
Apr
Apr
Dec
Dec
Dec
Dec
Dec
Dec
May
May
May
Jan
Jan
Jan
Jun
Jun
Jun

18,
18,
18,
08,
08,
08,
28,
28,
28,
28,
28,
28,
24,
24,
24,
14,
14,
14,
21,
21,
21,
27,
27,
27,
21,
21,
21,
21,
21,
21,
31,
31,
31,
14,
14,
14,
07,
07,
07,

2001
2001
2001
2011
2011
2011
1995
1995
1995
2007
2007
2007
2011
2011
2011
2011
2011
2011
1993
1993
1993
2005
2005
2005
1993
1993
1993
1993
1993
1993
1995
1995
1995
2004
2004
2004
2007
2007
2007

N020067 002
N020067 003

Oct 14, 1994

Oct 14, 1994

A075390
A075390
A091432
A091432
A075337
A075337
A075061
A075061
A075227
A075227

Apr
Apr
Sep
Sep
May
May
Feb
Feb
Jun
Jun

001
002
001
002
001
002
001
002
001
002

19,
19,
19,
19,
26,
26,
18,
18,
30,
30,

2001
2001
2011
2011
1999
1999
1998
1998
1998
1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 304 (of 424)

NAPROXEN SODIUM
TABLET; ORAL
ANAPROX
ROCHE PALO
AB
ANAPROX DS
AB + ROCHE PALO
NAPROXEN SODIUM
AMNEAL PHARMS NY
AB
AB
AUROBINDO PHARMA LTD
AB
AB
DR REDDYS LABS LTD
AB
AB
GLENMARK GENERICS
AB
AB
HIKMA
AB
AB
TEVA
AB
AB
WATSON LABS
AB
AB

EQ 250MG BASE

N018164 001

EQ 500MG BASE

N018164 003

Sep 30, 1987

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A078432
A078432
A200629
A200629
A078486
A078486
A078314
A078314
A074480
A074480
A074198
A074198
A074455
A074455

Apr
Apr
Oct
Oct
Jul
Jul
Apr
Apr
Feb
May
Dec
Dec
May
May

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

TABLET, EXTENDED RELEASE; ORAL

NAPRELAN
STAT TRADE
EQ 375MG BASE
XX
EQ 500MG BASE
XX
EQ 750MG BASE
XX +

001
002
001
002
001
002
001
002
002
001
001
002
001
002

25,
25,
31,
31,
26,
26,
27,
27,
18,
14,
21,
21,
31,
31,

2007
2007
2011
2011
2007
2007
2007
2007
1998
1996
1993
1993
1995
1995

N020353 001
N020353 002
N020353 003

Jan 05, 1996

Jan 05, 1996
Jan 05, 1996

500MG;EQ 85MG BASE

N021926 001

Apr 15, 2008

EQ 1MG BASE
EQ 2.5MG BASE
EQ 2.5MG BASE

A091373 001
A091373 002
A091552 001

Apr 22, 2011

Apr 22, 2011
Feb 14, 2011

EQ 1MG BASE
EQ 2.5MG BASE

N020763 002
N020763 001

Feb 10, 1998

Feb 10, 1998

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A200502
A200502
A091326
A091326
A090381
A090381
A090288
A090288
A078751
A078751

Feb
Feb
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

TABLET; ORAL

TREXIMET

XX + GLAXOSMITHKLINE

NARATRIPTAN
TABLET; ORAL
NARATRIPTAN
APOTEX CORP
AB
AB
SUN PHARM INDS LTD
AB

NARATRIPTAN HYDROCHLORIDE
TABLET; ORAL
AMERGE
GLAXOSMITHKLINE
AB
AB +
NARATRIPTAN
HERITAGE PHARMS INC
AB
AB
PADDOCK LLC
AB
AB
ROXANE
AB
AB
SANDOZ
AB
AB
TEVA PHARMS
AB
AB

1MG BASE
2.5MG BASE
1MG BASE
2.5MG BASE
1MG BASE
2.5MG BASE
1MG BASE
2.5MG BASE
1MG BASE
2.5MG BASE

001
002
001
002
001
002
001
002
001
002

28,
28,
08,
08,
07,
07,
07,
07,
07,
07,

2011
2011
2010
2010
2010
2010
2010
2010
2010
2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 305 (of 424)

NATAMYCIN
SUSPENSION; OPHTHALMIC

NATACYN

XX + ALCON

5%

N050514 001

60MG
120MG
60MG
120MG
60MG
120MG
60MG
120MG

A077461
A077461
A077463
A077463
A077467
A077467
A077462
A077462

60MG
120MG

N021204 001
N021204 002

Dec 22, 2000

Dec 22, 2000

EQ
EQ
EQ
EQ

N021742
N021742
N021742
N021742

Dec
Dec
Dec
Oct

NATEGLINIDE
TABLET; ORAL
NATEGLINIDE
DR REDDYS LABS LTD
AB
AB
PAR PHARM
AB
AB
TEVA PHARMS
AB
AB
WATSON LABS
AB
AB
STARLIX
NOVARTIS
AB
AB +

001
002
001
002
001
002
001
002

Sep
Sep
Sep
Sep
Sep
Sep
Mar
Mar

09,
09,
09,
09,
09,
09,
30,
30,

2009
2009
2009
2009
2009
2009
2011
2011

NEBIVOLOL HYDROCHLORIDE
TABLET; ORAL
BYSTOLIC
FOREST LABS
XX
XX
XX
XX +

2.5MG BASE
5MG BASE
10MG BASE
20MG BASE

002
003
004
005

17,
17,
17,
08,

2007
2007
2007
2008

NEDOCROMIL SODIUM
SOLUTION/DROPS; OPHTHALMIC

ALOCRIL

XX + ALLERGAN
2%

N021009 001

Dec 08, 1999

A076409
A076409
A076409
A076409
A076409
A076037
A076037
A076037
A076037
A076037

001
002
003
004
005
001
002
003
004
005

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

16,
16,
16,
16,
16,
16,
16,
16,
16,
16,

2003
2003
2003
2003
2003
2003
2003
2003
2003
2003

A076309
A076309
A076309
A076309
A076309

001
002
003
004
005

Sep
Sep
Sep
Sep
Sep

16,
16,
16,
16,
16,

2003
2003
2003
2003
2003

NEFAZODONE HYDROCHLORIDE
TABLET; ORAL
NEFAZODONE HYDROCHLORIDE
RANBAXY
AB
50MG
AB
100MG
AB
150MG
AB
200MG
AB
250MG
TEVA
AB
50MG
AB
100MG
AB
150MG
AB
200MG
AB +
250MG
NEFAZODONE HYDROCHLORIDE
BX
DR REDDYS LABS INC
50MG
BX
100MG
BX
150MG
BX
200MG
BX
250MG

NELARABINE
INJECTABLE; IV (INFUSION)

ARRANON

XX + SMITHKLINE BEECHAM
250MG/50ML (5MG/ML)

N021877 001

Oct 28, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 306 (of 424)

NELFINAVIR MESYLATE
POWDER; ORAL

VIRACEPT

XX + AGOURON

EQ 50MG BASE/SCOOPFUL

N020778 001

Mar 14, 1997

TABLET; ORAL

VIRACEPT

XX + AGOURON
XX +

EQ 250MG BASE
EQ 625MG BASE

N020779 001
N021503 001

Mar 14, 1997

Apr 30, 2003

NEOMYCIN SULFATE
POWDER; FOR RX COMPOUNDING

NEO-RX

XX
X GEN PHARMS
100%

A061579 001

SOLUTION; ORAL

NEO-FRADIN

XX + X GEN PHARMS

EQ 87.5MG BASE/5ML

A065010 001

May 23, 2002

TABLET; ORAL
NEOMYCIN SULFATE
OMAN PHARM PRODUCTS
AA
AA + TEVA
X GEN PHARMS
AA

500MG
500MG
500MG

A065468 001
A060304 001
A065220 001

Mar 29, 2010

UNITS/ML
UNITS/ML
UNITS/ML

A062664 001
A065106 001
A065108 001

Apr 08, 1986

Jan 31, 2006
Jan 31, 2006

UNITS/ML

A060707 001

Jul 28, 2006

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION; IRRIGATION
NEOMYCIN AND POLYMYXIN B SULFATE
WATSON LABS
AT
EQ 40MG BASE/ML;200,000
X GEN PHARMS
AT
EQ 40MG BASE/ML;200,000
AT
EQ 40MG BASE/ML;200,000
NEOSPORIN G.U. IRRIGANT
AT + MONARCH PHARMS
EQ 40MG BASE/ML;200,000

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

SUSPENSION/DROPS; OPHTHALMIC

POLY-PRED

EQ 0.35% BASE;10,000 UNITS/ML;0.5%

XX + ALLERGAN

N050081 002

NEPAFENAC
SUSPENSION/DROPS; OPHTHALMIC

NEVANAC

XX + ALCON PHARMS LTD

0.1%

N021862 001

Aug 19, 2005

N020920 001

Aug 10, 2001

NESIRITIDE RECOMBINANT
FOR SOLUTION; INTRAVENOUS

NATRECOR

1.5MG/VIAL
XX + SCIOS

NEVIRAPINE
SUSPENSION; ORAL

VIRAMUNE

XX + BOEHRINGER INGELHEIM

50MG/5ML

N020933 001

Sep 11, 1998

TABLET; ORAL

VIRAMUNE

XX + BOEHRINGER INGELHEIM

200MG

N020636 001

Jun 21, 1996

TABLET, EXTENDED RELEASE; ORAL

VIRAMUNE XR

XX + BOEHRINGER INGELHEIM 400MG

N201152 001

Mar 25, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 307 (of 424)

NIACIN
TABLET; ORAL
NIACIN
WOCKHARDT
AA
NIACOR
AA + UPSHER SMITH

500MG

A081134 001

Apr 28, 1992

500MG

A040378 001

May 03, 2000

TABLET, EXTENDED RELEASE; ORAL

NIASPAN
ABBOTT
500MG
XX
750MG
XX +
1GM
XX +

N020381 002
N020381 003
N020381 004

Jul 28, 1997

Jul 28, 1997
Jul 28, 1997

N022078
N022078
N022078
N022078
N022078

Feb
Jul
Feb
Feb
Jul

NIACIN; SIMVASTATIN

XX
XX
XX
XX
XX

TABLET, EXTENDED RELEASE; ORAL

SIMCOR

+ ABBOTT
500MG;20MG
+
500MG;40MG
+
750MG;20MG
+
1GM;20MG
+
1GM;40MG

001
004
002
003
005

15,
28,
15,
15,
28,

2008
2010
2008
2008
2010

NICARDIPINE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
CARDENE
EKR THERAP
20MG
+
30MG
NICARDIPINE HYDROCHLORIDE
BARR
20MG
30MG
EPIC PHARMA
20MG
30MG
MYLAN
20MG
30MG
TEVA
20MG
30MG
WATSON LABS
20MG
30MG

CAPSULE, EXTENDED RELEASE; ORAL

CARDENE SR

30MG
XX + EKR THERAP
60MG
XX +

AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
CARDENE
+ EKR THERAP
25MG/10ML
NICARDIPINE HYDROCHLORIDE
BEDFORD
25MG/10ML
BIONICHE PHARMA USA
25MG/10ML
EXELA PHARMA SCIENCE 25MG/10ML
NAVINTA LLC
25MG/10ML
PHARMAFORCE
25MG/10ML
SUN PHARMA GLOBAL
25MG/10ML
WOCKHARDT
25MG/10ML

N019488 001
N019488 002

Dec 21, 1988

Dec 21, 1988

A074439
A074439
A074928
A074928
A074642
A074642
A074540
A074540
A074670
A074670

Dec
Dec
Mar
Mar
Jul
Jul
Oct
Oct
Oct
Oct

001
002
001
002
001
002
001
002
001
002

10,
10,
19,
19,
18,
18,
28,
28,
28,
28,

1996
1996
1998
1998
1996
1996
1996
1996
1996
1996

N020005 001
N020005 003

Feb 21, 1992

Feb 21, 1992

(2.5MG/ML)

N019734 001

Jan 30, 1992

(2.5MG/ML)
(2.5MG/ML)
(2.5MG/ML)
(2.5MG/ML)
(2.5MG/ML)
(2.5MG/ML)
(2.5MG/ML)

A078714
A090664
N022276
A090125
A090534
N078405
A090671

Dec
Nov
Jul
Nov
Nov
Nov
Nov

INJECTABLE; INTRAVENOUS

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

40MG/200ML (0.2MG/ML)
XX + EKR THERAP
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
20MG/200ML (0.1MG/ML)
XX + EKR THERAP
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
20MG/200ML (0.1MG/ML)
XX + EKR THERAP

001
001
001
001
001
001
001

28,
17,
24,
17,
17,
17,
17,

2009
2009
2008
2009
2009
2009
2009

N019734 004

Nov 07, 2008

N019734 003

Jul 31, 2008

N019734 002

Jul 31, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 308 (of 424)

NICARDIPINE HYDROCHLORIDE
INJECTABLE; INTRAVENOUS

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

40MG/200ML (0.2MG/ML)
XX + EKR THERAP

N019734 005

Nov 07, 2008

NICOTINE
INHALANT; ORAL

NICOTROL

XX + PHARMACIA AND UPJOHN

4MG/CARTRIDGE

N020714 001

May 02, 1997

SPRAY, METERED; NASAL

NICOTROL

XX + PFIZER INC

0.5MG/SPRAY

N020385 001

Mar 22, 1996

10MG
10MG
10MG

A072579 001
A073250 001
A072781 001

Jan 08, 1991

Oct 08, 1991
Jul 30, 1993

10MG

N018482 001

20MG

A072556 001

Sep 20, 1990

30MG
60MG
90MG

N020198 001
N020198 002
N020198 003

Apr 21, 1993

Apr 21, 1993
Apr 21, 1993

30MG
60MG

A075128 001
A075659 001

Mar 10, 2000

Oct 26, 2001

30MG
60MG
30MG
60MG
90MG
30MG
60MG
90MG

A077899
A077899
A201071
A201071
A201071
A075269
A075269
A076070

001
002
001
002
003
001
002
001

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Aug

13,
13,
03,
03,
03,
04,
04,
16,

2006
2006
2010
2010
2010
2000
2000
2002

30MG
60MG
90MG
30MG
60MG
90MG
30MG
60MG
90MG
30MG
60MG

A090602
A090602
A090602
A090649
A090649
A090649
A077127
A077127
A077410
A075289
A075289

001
002
003
001
002
003
001
002
001
002
001

Sep
Sep
Sep
Jun
Jun
Jun
Nov
Nov
Oct
Feb
Sep

13,
13,
13,
21,
21,
21,
21,
21,
03,
06,
27,

2010
2010
2010
2010
2010
2010
2005
2005
2007
2001
2000

30MG
60MG
90MG

N019684 001
N019684 002
N019684 003

NIFEDIPINE

AB
AB
AB
AB
XX

CAPSULE; ORAL
NIFEDIPINE
ACTAVIS ELIZABETH
CATALENT
INTERGEL PHARM
PROCARDIA
+ PFIZER
NIFEDIPINE
ACTAVIS ELIZABETH

TABLET, EXTENDED RELEASE;

ADALAT CC
BAYER HLTHCARE
AB1
AB1 +
AB1 +
AFEDITAB CR
WATSON LABS
AB1
AB1
NIFEDIPINE
ACTAVIS
AB1
AB1
MYLAN
AB1
AB1
AB1
VALEANT INTL
AB1
AB1
AB1
NIFEDIPINE
MATRIX LABS LTD
AB2
AB2
AB2
MYLAN
AB2
AB2
AB2
OSMOTICA PHARM
AB2
AB2
AB2
VALEANT INTL
AB2
AB2
PROCARDIA XL
PFIZER
AB2
AB2
AB2 +

ORAL

Sep 06, 1989

Sep 06, 1989
Sep 06, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 309 (of 424)

NILOTINIB HYDROCHLORIDE MONOHYDRATE

CAPSULE; ORAL
TASIGNA
NOVARTIS
XX
XX +

EQ 150MG BASE
EQ 200MG BASE

N022068 002
N022068 001

Jun 17, 2010

Oct 29, 2007

150MG

N020169 002

Apr 30, 1999

30MG
30MG
30MG

A076740 001
A077811 001
A077067 001

Jan 17, 2008

May 02, 2007
Apr 17, 2007

A091001
A091001
A091001
A091001

001
002
003
004

Jan
Jan
Jan
Jan

26,
26,
26,
26,

2011
2011
2011
2011

N020356
N020356
N020356
N020356

008
007
006
005

Jan
Jan
Jan
Jan

02,
02,
02,
02,

2008
2008
2008
2008

NILUTAMIDE
TABLET; ORAL

NILANDRON

XX + SANOFI AVENTIS US

NIMODIPINE
CAPSULE; ORAL
NIMODIPINE
BANNER PHARMACAPS
AB
BARR LABS INC
AB
AB + SUN PHARM INDS INC

NISOLDIPINE
TABLET, EXTENDED RELEASE; ORAL
NISOLDIPINE
MYLAN
AB
8.5MG
AB
17MG
AB
25.5MG
AB
34MG
SULAR
AB + SHIONOGI INC
8.5MG
AB +
17MG
AB
25.5MG
AB +
34MG
NISOLDIPINE
20MG
XX + MYLAN
30MG
XX +
40MG
XX +

A079051 001
A079051 002
A079051 003

Jul 25, 2008

Jul 25, 2008
Jul 25, 2008

NITAZOXANIDE
FOR SUSPENSION; ORAL

ALINIA

XX + ROMARK

100MG/5ML

N021498 001

Nov 22, 2002

TABLET; ORAL

ALINIA

XX + ROMARK

500MG

N021497 001

Jul 21, 2004

2MG
5MG
10MG

N021232 001
N021232 002
N021232 003

Jan 18, 2002

Jan 18, 2002
Jan 18, 2002

100PPM
800PPM

N020845 002
N020845 003

Dec 23, 1999

Dec 23, 1999

NITISINONE
CAPSULE; ORAL
ORFADIN
RARE DIS
XX
XX
XX +

NITRIC OXIDE
GAS; INHALATION
INOMAX
INO
XX
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 310 (of 424)

NITROFURANTOIN
SUSPENSION; ORAL
FURADANTIN
AB + SHIONOGI INC
NITROFURANTOIN
AMNEAL PHARMS
AB

25MG/5ML

N009175 001

25MG/5ML

A201679 001

May 11, 2011

NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE; ORAL
MACRODANTIN
ALVOGEN
AB
AB
AB +
NITROFURANTOIN
IVAX SUB TEVA PHARMS
AB
AB
MYLAN
AB
AB
WATSON LABS
AB
AB
AB

25MG
50MG
100MG

N016620 003
N016620 001
N016620 002

50MG
100MG
50MG
100MG
25MG
50MG
100MG

A073671
A073652
A074967
A077025
A073696
A073696
A073696

001
001
001
001
001
002
003

Jan
Jan
Jul
Aug
Dec
Dec
Dec

28,
28,
09,
18,
31,
31,
31,

1993
1993
1997
2004
1992
1992
1992

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

AB
AB
AB
AB

CAPSULE; ORAL
MACROBID
+ ALVOGEN
75MG;25MG
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
MYLAN
75MG;25MG
RANBAXY
75MG;25MG
SANDOZ
75MG;25MG

N020064 001

Dec 24, 1991

A076648 001
A076951 001
A077066 001

Mar 22, 2004

Mar 30, 2005
Apr 05, 2005

N021780 001

Nov 02, 2006

A089771
A089772
A089773
A089774

001
001
001
001

Aug
Aug
Aug
Aug

30,
30,
30,
30,

1996
1996
1996
1996

N020145
N020145
N020145
N020145

001
002
004
005

Apr
Apr
Apr
Apr

04,
04,
04,
04,

1995
1995
1995
1995

NITROGLYCERIN
AEROSOL, METERED; SUBLINGUAL

NITROMIST

0.4MG/SPRAY
XX + NOVADEL
FILM, EXTENDED RELEASE; TRANSDERMAL
MINITRAN
GRACEWAY
AB1
0.1MG/HR
AB1
0.2MG/HR
AB1
0.4MG/HR
AB1
0.6MG/HR
NITRO-DUR
AB1 + KEY PHARMS
0.1MG/HR
AB1 +
0.2MG/HR
AB1 +
0.4MG/HR
AB1 +
0.6MG/HR
NITROGLYCERIN
KREMERS URBAN PHARMS 0.2MG/HR
AB1
AB1
0.4MG/HR
NITROGLYCERIN
HERCON LABS
AB2
0.2MG/HR
AB2
0.4MG/HR
AB2
0.6MG/HR
AB2 + MYLAN TECHNOLOGIES
0.2MG/HR
AB2 +
0.4MG/HR
AB2 +
0.6MG/HR
NITRO-DUR
0.3MG/HR
XX + KEY PHARMS
0.8MG/HR
XX +

A075115 001
A075115 002

Aug 10, 2004

Aug 10, 2004

A089884
A089885
A089886
A074559
A074559
A074559

Oct
Oct
Oct
Aug
Aug
Aug

001
001
001
003
002
001

N020145 003
N020145 006

30,
30,
30,
30,
30,
30,

1998
1998
1998
1996
1996
1996

Apr 04, 1995

Apr 04, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 311 (of 424)

NITROGLYCERIN
FILM, EXTENDED RELEASE; TRANSDERMAL

NITROGLYCERIN

0.1MG/HR
XX + MYLAN TECHNOLOGIES

AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
NITROGLYCERIN
+ HOSPIRA
5MG/ML
+ LUITPOLD
5MG/ML
NITROGLYCERIN IN DEXTROSE 5%
+ BAXTER HLTHCARE
10MG/100ML
+
20MG/100ML
+
40MG/100ML
HOSPIRA
10MG/100ML
20MG/100ML
40MG/100ML

A074559 004

Feb 06, 1998

N018531 001
A072034 001

May 24, 1988

N019970
N019970
N019970
A071846
A071847
A071848

Dec
Dec
Dec
Aug
Aug
Aug

001
002
003
001
001
001

29,
29,
29,
31,
31,
31,

1989
1989
1989
1990
1990
1990

OINTMENT; INTRA-ANAL

RECTIV

XX + PROSTRAKAN INC

0.4%

N021359 001

Jun 21, 2011

OINTMENT; TRANSDERMAL

NITROGLYCERIN

XX + FOUGERA

2%

A087355 001

Jul 08, 1988

SPRAY, METERED; SUBLINGUAL

NITROLINGUAL PUMPSPRAY

0.4MG/SPRAY
XX + POHL BOSKAMP

N018705 002

Jan 10, 1997

TABLET; SUBLINGUAL
NITROSTAT
PFIZER PHARMS
XX
XX
XX +

0.3MG
0.4MG
0.6MG

N021134 001
N021134 002
N021134 003

May 01, 2000

May 01, 2000
May 01, 2000

150MG
300MG

N019508 001
N019508 002

Apr 12, 1988

Apr 12, 1988

150MG
300MG
150MG
300MG
150MG
300MG
150MG
150MG
300MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG

A076383
A076383
A077314
A077314
A090618
A090618
A075806
A075934
A075806
A075934
A076178
A076178
A075668
A075668
A075616
A075616

Jan
Jan
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Sep
Sep
Jul
Jul

15MG/ML

N021494 001

May 25, 2004

15MG/ML

A090576 001

Nov 18, 2009

NIZATIDINE
CAPSULE; ORAL
AXID
SMITHKLINE BEECHAM
AB
AB +
NIZATIDINE
APOTEX
AB
AB
DR REDDYS LABS LTD
AB
AB
GLENMARK GENERICS
AB
AB
MYLAN
AB
AB
AB
AB
SANDOZ
AB
AB
TEVA
AB
AB
WATSON LABS
AB
AB
SOLUTION; ORAL
AXID
AA + BRAINTREE
NIZATIDINE
AMNEAL PHARMS
AA

001
002
001
002
001
002
001
001
002
002
001
002
001
002
001
002

23,
23,
15,
15,
15,
15,
05,
09,
05,
09,
05,
05,
12,
12,
09,
09,

2003
2003
2005
2005
2011
2011
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 312 (of 424)

NOREPINEPHRINE BITARTRATE
INJECTABLE; INJECTION
LEVOPHED
AP + HOSPIRA
EQ 1MG BASE/ML
NOREPINEPHRINE BITARTRATE
BEDFORD
AP
EQ 1MG BASE/ML
TEVA PARENTERAL
AP
EQ 1MG BASE/ML

N007513 001
A040462 001
A040455 001

Oct 31, 2003

Mar 03, 2003

0.35MG

A076177 001

Oct 21, 2002

0.35MG

A090454 001

Apr 23, 2010

0.35MG

A091325 001

Sep 19, 2011

0.35MG

N017060 001

0.35MG

A076225 001

0.35MG

N016954 001

0.35MG

A091209 001

Jul 21, 2010

5MG

N018405 001

Apr 21, 1982

5MG
5MG

A075951 001
A091090 001

May 25, 2001

Jul 21, 2010

400MG

N019384 002

Oct 31, 1986

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A074234
A074234
A074234
A074234
A075520
A075520
A075520
A075520
A074132
A074132
A074132
A074132
A073553
A073554
A073555
A073556

Jul
Jul
Jul
Jul
May
May
May
May
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

BASE
BASE

N018013 001
N018013 002

NORETHINDRONE
TABLET; ORAL-28
CAMILA
BARR
AB1
HEATHER
GLENMARK GENERICS
AB1
NORETHINDRONE
LUPIN LTD
AB1
NOR-QD
AB1 + WATSON LABS (UTAH)
ERRIN
BARR
AB2
MICRONOR
AB2 + JANSSEN PHARMS
NORETHIDRONE
GLENMARK GENERICS
AB2

Oct 21, 2002

NORETHINDRONE ACETATE
TABLET; ORAL
AYGESTIN
AB + DURAMED RES
NORETHINDRONE ACETATE
BARR
AB
GLENMARK GENERICS
AB

NORFLOXACIN
TABLET; ORAL

NOROXIN

XX + MERCK

NORTRIPTYLINE HYDROCHLORIDE
CAPSULE; ORAL
NORTRIPTYLINE HYDROCHLORIDE
MYLAN
AB
EQ 10MG
AB
EQ 25MG
AB
EQ 50MG
AB
EQ 75MG
TARO
AB
EQ 10MG
AB
EQ 25MG
AB
EQ 50MG
AB
EQ 75MG
TEVA
AB
EQ 10MG
AB
EQ 25MG
AB
EQ 50MG
AB
EQ 75MG
WATSON LABS
AB
EQ 10MG
AB
EQ 25MG
AB
EQ 50MG
AB
EQ 75MG
PAMELOR
MALLINCKRODT LLC
AB
EQ 10MG
AB
EQ 25MG

001
002
003
004
004
003
001
002
001
002
003
004
001
001
001
001

26,
26,
26,
26,
08,
08,
08,
08,
27,
27,
27,
27,
30,
30,
30,
30,

1993
1993
1993
1993
2000
2000
2000
2000
1995
1995
1995
1995
1992
1992
1992
1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 313 (of 424)

NORTRIPTYLINE HYDROCHLORIDE
CAPSULE; ORAL
PAMELOR
MALLINCKRODT LLC
AB
AB +

EQ 50MG BASE
EQ 75MG BASE

SOLUTION; ORAL
AVENTYL HYDROCHLORIDE
AA + RANBAXY
EQ 10MG BASE/5ML
NORTRIPTYLINE HYDROCHLORIDE
PHARM ASSOC
AA
EQ 10MG BASE/5ML
TARO
AA
EQ 10MG BASE/5ML

N018013 004
N018013 003

N014685 001
A075606 001
A077965 001

Aug 28, 2000

Jun 20, 2006

A062949
A062129
A062225
A064022
A065315

001
001
001
001
001

Jun 13, 1988

100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/GM

A062840 001
A062124 002
A062472 001

Nov 13, 1987

Sep 23, 1982
Feb 13, 1984

100,000
100,000
100,000
100,000
100,000

A065203
A065321
A065138
A065183
A065175

Jul
Aug
Jul
May
Dec

NYSTATIN

AT
AT
AT
AT
AT

CREAM; TOPICAL
NYSTATIN
ACTAVIS MID ATLANTIC
ALTANA
PERRIGO NEW YORK
TARO
VINTAGE

OINTMENT; TOPICAL
NYSTATIN
ACTAVIS MID ATLANTIC
AT
AT + ALTANA
PERRIGO NEW YORK
AT

AT
AT
AT
AT
AT
AT

AA
AA
AA
AA
AA
AA
AA
AA
AA

POWDER; TOPICAL
NYSTATIN
+ COASTAL PHARMS
NESHER PHARMS
PAR PHARM
UPSHER SMITH
X GEN PHARMS
NYSTOP
PADDOCK LLC
SUSPENSION; ORAL
NILSTAT
+ GLENMARK GENERICS
NYSTATIN
ACTAVIS MID ATLANTIC
FOUGERA
HI TECH PHARMA
TARO
VINTAGE PHARMS
VISTAPHARM
+

WOCKHARDT

100,000
100,000
100,000
100,000
100,000

UNITS/GM
UNITS/GM
UNITS/GM
UNITS/GM
UNITS/GM

UNITS/GM
UNITS/GM
UNITS/GM
UNITS/GM
UNITS/GM

001
001
001
001
001

100,000 UNITS/GM

A064118 001

100,000 UNITS/ML

N050299 001

100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000

A062349
A062517
A064042
A062876
A065148
A064142
A065422
A062512

UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML

001
001
001
001
001
001
001
001

Jan 29, 1993

May 31, 2006

15,
18,
23,
03,
17,

2004
2006
2004
2005
2004

Aug 16, 1996

Jul
Jun
Feb
Feb
Jun
Jun
Mar
Oct

14,
07,
28,
29,
28,
25,
07,
29,

1982
1984
1994
1988
2005
1998
2011
1984

TABLET; ORAL
NYSTATIN
MUTUAL PHARM
AA
AA + TEVA

500,000 UNITS
500,000 UNITS

A062838 001
A062506 001

Dec 22, 1988

Jan 16, 1984

TABLET; VAGINAL

NYSTATIN

XX + ODYSSEY PHARMS

100,000 UNITS

A062615 001

Oct 17, 1985

A062599 001
A062364 001

Oct 08, 1985

Dec 22, 1987

NYSTATIN; TRIAMCINOLONE ACETONIDE

CREAM; TOPICAL
NYSTATIN AND TRIAMCINOLONE ACETONIDE
FOUGERA
AT
100,000 UNITS/GM;0.1%
AT + TARO
100,000 UNITS/GM;0.1%

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 314 (of 424)

NYSTATIN; TRIAMCINOLONE ACETONIDE

OINTMENT; TOPICAL
NYSTATIN AND TRIAMCINOLONE ACETONIDE
FOUGERA
AT
100,000 UNITS/GM;0.1%
AT + TARO
100,000 UNITS/GM;0.1%

A062602 001
A063305 001

Oct 09, 1985

Mar 29, 1993

A077450
A077450
A076330
A076330
A077329
A077372
A077329
A077372
A077330
A077373
A077329
A077372
A077331
A077373
A075957
A075957
A075959
A075957
A075959
A090986
A090986

001
002
001
002
001
001
002
002
001
001
003
003
001
002
001
002
001
003
002
001
002

Feb
Feb
Apr
Apr
Mar
Aug
Mar
Aug
Mar
Aug
Mar
Aug
Mar
Aug
Oct
Oct
Nov
Oct
Nov
May
May

10,
10,
08,
08,
04,
14,
04,
14,
04,
14,
04,
14,
04,
14,
03,
03,
21,
03,
21,
11,
11,

2006
2006
2005
2005
2008
2007
2008
2007
2008
2007
2008
2007
2008
2007
2005
2005
2005
2005
2005
2011
2011

A077457
A077457
A077457
A076313
A076313
A076313
A079198
A079198
A079198
A090985
A090985
A090985

001
002
003
001
003
002
001
002
003
001
002
003

Feb
Feb
Feb
Mar
Mar
Mar
Feb
Feb
Feb
May
May
May

10,
10,
10,
28,
28,
28,
10,
10,
10,
11,
11,
11,

2006
2006
2006
2005
2005
2005
2011
2011
2011
2011
2011
2011

N019667
N019667
N019667
N019667
N019667

001
002
004
003
005

Oct
Oct
Jun
Oct
Jun

21,
21,
12,
21,
12,

1988
1988
1991
1988
1991

OCTREOTIDE ACETATE
INJECTABLE; INJECTION
OCTREOTIDE ACETATE
APP PHARMS
AP
EQ 0.2MG BASE/ML
AP
EQ 1MG BASE/ML
AP + BEDFORD
EQ 0.2MG BASE/ML
AP +
EQ 1MG BASE/ML
SUN PHARM INDS
AP
EQ 0.05MG BASE/ML
AP
EQ 0.05MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.2MG BASE/ML
AP
EQ 0.2MG BASE/ML
AP
EQ 0.5MG BASE/ML
AP
EQ 0.5MG BASE/ML
AP
EQ 1MG BASE/ML
AP
EQ 1MG BASE/ML
TEVA PARENTERAL
AP
EQ 0.05MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.2MG BASE/ML
AP
EQ 0.5MG BASE/ML
AP
EQ 1MG BASE/ML
WOCKHARDT USA
AP
EQ 0.2MG BASE/ML
AP
EQ 1MG BASE/ML
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
APP PHARMS
AP
EQ 0.05MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.5MG BASE/ML
AP + BEDFORD
EQ 0.05MG BASE/ML
AP +
EQ 0.1MG BASE/ML
AP +
EQ 0.5MG BASE/ML
MYLAN INSTITUTIONAL
AP
EQ 0.05MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.5MG BASE/ML
WOCKHARDT USA
AP
EQ 0.05MG BASE/ML
AP
EQ 0.1MG BASE/ML
AP
EQ 0.5MG BASE/ML
SANDOSTATIN
AP + NOVARTIS
EQ 0.05MG BASE/ML
AP +
EQ 0.1MG BASE/ML
AP +
EQ 0.2MG BASE/ML
AP +
EQ 0.5MG BASE/ML
AP +
EQ 1MG BASE/ML
SANDOSTATIN LAR
NOVARTIS
EQ 10MG BASE/VIAL
XX
EQ 20MG BASE/VIAL
XX
EQ 30MG BASE/VIAL
XX +

N021008 001
N021008 002
N021008 003

Nov 25, 1998

Nov 25, 1998
Nov 25, 1998

N019921 001

Jul 30, 1993

A076407 001

Apr 15, 2008

OFLOXACIN
SOLUTION/DROPS; OPHTHALMIC
OCUFLOX
AT + ALLERGAN
0.3%
OFLOXACIN
AKORN
AT
0.3%

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 315 (of 424)

OFLOXACIN

AT
AT
AT
AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
OFLOXACIN
ALCON PHARMS LTD
0.3%
BAUSCH AND LOMB
0.3%
FDC LTD
0.3%
FERA PHARMS
0.3%
HI TECH PHARMA
0.3%
NOVEX
0.3%
SANDOZ
0.3%

A076231
A076622
A078559
A076830
A076615
A076513
A076848

001
001
001
001
001
001
001

May
May
Feb
Aug
May
May
Nov

14,
14,
25,
31,
14,
14,
25,

2004
2004
2009
2004
2004
2004
2008

SOLUTION/DROPS; OTIC
FLOXIN OTIC
+ DAIICHI
OFLOXACIN
ALCON PHARMS LTD
APOTEX INC
BAUSCH AND LOMB
FERA PHARMS
HI TECH PHARMA

0.3%

N020799 001

Dec 16, 1997

0.3%
0.3%
0.3%
0.3%
0.3%

A078222
A076527
A076128
A090395
A076616

001
001
001
001
001

Mar
Sep
Mar
Aug
Mar

17,
28,
17,
11,
17,

2008
2007
2008
2009
2008

TABLET; ORAL
OFLOXACIN
DR REDDYS LABS LTD
AB
AB
AB
RANBAXY
AB
AB
AB
TEVA
AB
AB
AB +

200MG
300MG
400MG
200MG
300MG
400MG
200MG
300MG
400MG

A077098
A077098
A077098
A076220
A076220
A076220
A076182
A076182
A076182

001
002
003
001
002
003
001
002
003

Feb
Feb
Feb
Sep
Sep
Sep
Sep
Sep
Sep

10,
10,
10,
02,
02,
02,
02,
02,
02,

2006
2006
2006
2003
2003
2003
2003
2003
2003

AT
AT
AT
AT
AT
AT

OLANZAPINE
INJECTABLE; INTRAMUSCULAR
OLANZAPINE
INNOPHARMA LLC
AP
10MG/VIAL
ZYPREXA
AP + LILLY
10MG/VIAL
TABLET; ORAL
OLANZAPINE
DR REDDYS LABS LTD
AB
TEVA PHARMS
AB
AB
AB
AB
AB
ZYPREXA
LILLY
AB
AB +
AB
AB
AB
AB

A201588 001

Oct 24, 2011

N021253 001

Mar 29, 2004

20MG
2.5MG
5MG
7.5MG
10MG
15MG

A076133
A076000
A076000
A076000
A076000
A076000

002
001
002
003
004
005

Oct
Oct
Oct
Oct
Oct
Oct

24,
24,
24,
24,
24,
24,

2011
2011
2011
2011
2011
2011

2.5MG
5MG
7.5MG
10MG
15MG
20MG

N020592
N020592
N020592
N020592
N020592
N020592

001
002
003
004
005
006

Sep
Sep
Sep
Sep
Sep
Sep

30,
30,
30,
30,
09,
09,

1996
1996
1996
1996
1997
1997

A091265
A091265
A091265
A091265
A076534

001
002
003
004
001

Oct
Oct
Oct
Oct
Oct

24,
24,
24,
24,
24,

2011
2011
2011
2011
2011

TABLET, ORALLY DISINTEGRATING; ORAL

OLANZAPINE
APOTEX INC
AB
5MG
AB
10MG
AB
15MG
AB
20MG
DR REDDYS LABS LTD
AB
5MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 316 (of 424)

OLANZAPINE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET, ORALLY DISINTEGRATING; ORAL

OLANZAPINE
DR REDDYS LABS LTD
10MG
15MG
20MG
PAR PHARM
5MG
10MG
15MG
20MG
TORRENT PHARMS LLC
5MG
10MG
15MG
20MG
ZYPREXA ZYDIS
+ LILLY
5MG
10MG
15MG
20MG

A076534
A076534
A076534
A078109
A078109
A078109
A078109
A091415
A091415
A091415
A091415

002
003
004
001
002
003
004
001
002
003
004

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

24,
24,
24,
24,
24,
24,
24,
25,
25,
25,
25,

2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011

N021086
N021086
N021086
N021086

001
002
003
004

Apr
Apr
Apr
Apr

06,
06,
06,
06,

2000
2000
2000
2000

OLANZAPINE PAMOATE
SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
ZYPREXA RELPREVV
ELI LILLY CO
EQ 210MG BASE/VIAL
XX
EQ 300MG BASE/VIAL
XX
EQ 405MG BASE/VIAL
XX +

N022173 001
N022173 002
N022173 003

Dec 11, 2009

Dec 11, 2009
Dec 11, 2009

N021286 001
N021286 003
N021286 004

Apr 25, 2002

Apr 25, 2002
Apr 25, 2002

N021545 001

Dec 22, 2004

N020688 001

Dec 18, 1996

0.665MG/SPRAY

N021861 001

Apr 15, 2008

250MG

N019715 001

Jul 31, 1990

1GM CONTAINS AT LEAST 900MG OF THE

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

N021654 001

Nov 10, 2004

A076048 001

Oct 22, 2007

OLMESARTAN MEDOXOMIL
TABLET; ORAL
BENICAR
XX
DAIICHI SANKYO
XX
XX +

5MG
20MG
40MG

OLOPATADINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC

PATADAY

XX + ALCON PHARMS LTD

EQ 0.2% BASE
PATANOL
XX + ALCON
EQ 0.1% BASE
SPRAY, METERED; NASAL

PATANASE

XX + ALCON PHARMS LTD

OLSALAZINE SODIUM
CAPSULE; ORAL

DIPENTUM

XX + MEDA PHARMS

OMEGA-3-ACID ETHYL ESTERS

CAPSULE; ORAL

LOVAZA

XX + SMITHKLINE BEECHAM

OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL
OMEPRAZOLE
APOTEX
AB
10MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 317 (of 424)

OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL
OMEPRAZOLE
APOTEX
AB
20MG
AB
40MG
DR REDDYS LABS
AB
40MG
DR REDDYS LABS LTD
AB
10MG
AB
10MG
AB
20MG
AB
20MG
AB
40MG
IMPAX LABS
AB
10MG
AB
20MG
AB
40MG
KREMERS URBAN PHARMS 10MG
AB
AB
20MG
AB
40MG
LEK PHARMS
AB
10MG
AB
20MG
MYLAN
AB
10MG
AB
20MG
AB
40MG
SANDOZ
AB
40MG
WATSON LABS FLORIDA
AB
10MG
AB
20MG
AB
40MG
PRILOSEC
ASTRAZENECA
AB
10MG
AB +
20MG
AB +
40MG

A076048
A076048
A078490
A075576
A078693
A075576
A078693
A075576
A075785
A075785
A075785
A075410
A075410
A075410
A075757
A075757
A075876
A075876
A075876
A076515
A075347
A075347
A075347

002
003
001
003
001
002
002
001
001
002
003
001
002
003
001
002
001
002
003
001
001
002
003

Oct
Jan
Apr
Oct
Mar
Oct
Mar
Jan
Oct
Oct
Jan
Nov
Nov
Jan
Jan
Jan
May
May
Jan
Jan
May
May
May

22,
21,
17,
22,
16,
22,
16,
21,
22,
22,
21,
01,
01,
23,
28,
28,
29,
29,
21,
21,
30,
30,
30,

2007
2009
2009
2007
2009
2007
2009
2009
2007
2007
2009
2002
2002
2009
2003
2003
2003
2003
2009
2009
2008
2008
2008

N019810 003
N019810 001
N019810 002

Oct 05, 1995

Sep 14, 1989
Jan 15, 1998

N022056 001
N022056 002

Mar 20, 2008

Mar 20, 2008

OMEPRAZOLE MAGNESIUM
FOR SUSPENSION, DELAYED RELEASE; ORAL
PRILOSEC
ASTRAZENECA
EQ 2.5MG BASE/PACKET
XX
EQ 10MG BASE/PACKET
XX +

OMEPRAZOLE; SODIUM BICARBONATE

CAPSULE; ORAL
OMEPRAZOLE AND SODIUM BICARBONATE
PAR PHARM
AB
20MG;1.1GM
AB
40MG;1.1GM
ZEGERID
SANTARUS
AB
20MG;1.1GM
AB +
40MG;1.1GM

A078966 001
A078966 002

May 25, 2010

May 25, 2010

N021849 001
N021849 002

Feb 27, 2006

Feb 27, 2006

FOR SUSPENSION; ORAL

ZEGERID
SANTARUS
XX
XX +

20MG/PACKET;1.68GM/PACKET
40MG/PACKET;1.68GM/PACKET

N021636 001
N021636 002

Jun 15, 2004

Dec 21, 2004

4MG
8MG

N022524 001
N022524 002

Jul 02, 2010

Jul 02, 2010

A090469 001
A090469 002

Apr 12, 2010

Apr 12, 2010

ONDANSETRON
FILM; ORAL
ZUPLENZ
MONOSOL RX LLC
XX
XX +

TABLET, ORALLY DISINTEGRATING; ORAL

ONDANSETRON
AUROBINDO PHARMA
AB
4MG
AB
8MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 318 (of 424)

ONDANSETRON
TABLET, ORALLY DISINTEGRATING; ORAL
ONDANSETRON
BARR
AB
4MG
AB
8MG
GLENMARK GENERICS
AB
4MG
AB
8MG
MYLAN
AB
4MG
AB
8MG
NESHER PHARMS
AB
4MG
AB
8MG
PAR PHARM
AB
4MG
AB
8MG
RANBAXY
AB
4MG
AB
8MG
SANDOZ
AB
4MG
AB
8MG
SUN PHARM INDS
AB
4MG
AB
8MG
TEVA
AB
4MG
AB
8MG
ZOFRAN ODT
GLAXOSMITHKLINE
AB
4MG
AB +
8MG
ONDANSETRON
PAR PHARM
16MG
XX
24MG
XX

A076693
A076693
A078152
A078152
A078139
A078139
A077717
A077717
A076506
A076506
A078602
A078602
A078050
A078050
A077557
A077557
A076810
A076810

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Dec
Dec
Feb
Feb
Aug
Aug
Aug
Aug
Jun
Jun

25,
25,
27,
27,
25,
25,
25,
25,
26,
26,
24,
24,
13,
13,
02,
02,
25,
25,

2007
2007
2007
2007
2007
2007
2007
2007
2006
2006
2011
2011
2007
2007
2007
2007
2007
2007

N020781 001
N020781 002

Jan 27, 1999

Jan 27, 1999

A077406 001
A077406 002

Dec 26, 2006

Dec 26, 2006

ONDANSETRON HYDROCHLORIDE

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

INJECTABLE; INJECTION
ONDANSETRON HYDROCHLORIDE
APOTEX
EQ 2MG BASE/ML
A077368
APP PHARMS
EQ 2MG BASE/ML
A076974
BAXTER HLTHCARE
EQ 2MG BASE/ML
A077365
BEDFORD
EQ 2MG BASE/ML
A076967
EMCURE PHARMS
EQ 2MG BASE/ML
A090424
GLAND PHARMA LTD
EQ 2MG BASE/ML
A079224
HIKMA FARMACEUTICA
EQ 2MG BASE/ML
A076781
HOSPIRA
EQ 2MG BASE/ML
A077473
EQ 2MG BASE/ML
A077840
LANNETT
EQ 2MG BASE/ML
A090116
EQ 2MG BASE/ML
A090883
LUITPOLD
EQ 2MG BASE/ML
A077582
EQ 2MG BASE/ML
A079039
PFIZER
EQ 2MG BASE/ML
A078257
PLIVA HRVATSKA DOO
EQ 2MG BASE/ML
A077544
SANDOZ
EQ 2MG BASE/ML
A077430
SPECTRUM PHARMS
EQ 2MG BASE/ML
A078180
SUN PHARM INDS (IN)
EQ 2MG BASE/ML
A077172
TEVA
EQ 2MG BASE/ML
A076876
WOCKHARDT
EQ 2MG BASE/ML
A077577
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
BEDFORD LABS
EQ 0.64MG BASE/ML
A078291
CLARIS LIFESCIENCES
EQ 0.64MG BASE/ML
A078308
+ HOSPIRA
EQ 0.64MG BASE/ML
A077348
TEVA PHARMS
EQ 0.64MG BASE/ML
A077480
ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
EQ 0.64MG BASE/ML
N021915
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
APOTEX INC
EQ 2MG BASE/ML
A077343

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Dec
Dec
Dec
Dec
Apr
Sep
Dec
Dec
Jan
Apr
Aug
Dec
Nov
Apr
Dec
Jun
Mar
Dec
Nov
Dec

26,
26,
26,
26,
16,
25,
26,
26,
19,
14,
05,
26,
18,
23,
26,
27,
26,
26,
22,
26,

2006
2006
2006
2006
2010
2009
2006
2006
2007
2010
2010
2006
2008
2008
2006
2007
2007
2006
2006
2006

001
001
001
001

Apr
Mar
Feb
Nov

13,
17,
01,
22,

2009
2008
2007
2006

002

Dec 27, 2006

001

Dec 26, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 319 (of 424)

ONDANSETRON HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

AA
AA
AA
AA
AA
AA
AA

INJECTABLE; INJECTION
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
APP PHARMS
EQ 2MG BASE/ML
BAXTER HLTHCARE
EQ 2MG BASE/ML
BEDFORD LABS
EQ 2MG BASE/ML
HIKMA FARMACEUTICA
EQ 2MG BASE/ML
HOSPIRA
EQ 2MG BASE/ML
LUITPOLD
EQ 2MG BASE/ML
EQ 2MG BASE/ML
PFIZER
EQ 2MG BASE/ML
SANDOZ
EQ 2MG BASE/ML
SUN PHARM INDS LTD
EQ 2MG BASE/ML
TARO PHARMS IRELAND
EQ 2MG BASE/ML
TEVA
EQ 2MG BASE/ML
WOCKHARDT
EQ 2MG BASE/ML
ZOFRAN
+ GLAXOSMITHKLINE
EQ 2MG BASE/ML
ZOFRAN PRESERVATIVE FREE
+ GLAXOSMITHKLINE
EQ 2MG BASE/ML
SOLUTION; ORAL
ONDANSETRON HYDROCHLORIDE
AMNEAL PHARMS
EQ
APOTEX
EQ
AUROBINDO PHARMA
EQ
ROXANE
EQ
SILARX
EQ
TARO
EQ
ZOFRAN
+ GLAXOSMITHKLINE
EQ

TABLET; ORAL
ONDANSETRON HYDROCHLORIDE
APOTEX
AB
EQ
AB
EQ
AUROBINDO PHARMA
AB
EQ
AB
EQ
AB
EQ
DR REDDYS LABS LTD
AB
EQ
AB
EQ
AB
EQ
GLENMARK GENERICS
AB
EQ
AB
EQ
AB
EQ
MYLAN
AB
EQ
AB
EQ
AB
EQ
NATCO PHARMA LTD
AB
EQ
AB
EQ
PAR PHARM
AB
EQ
AB
EQ
AB
EQ
PLIVA HRVATSKA DOO
AB
EQ
AB
EQ
AB
EQ
SANDOZ
AB
EQ
AB
EQ
AB
EQ
SUN PHARM INDS (IN)
AB
EQ
AB
EQ
TARO
AB
EQ

4MG
4MG
4MG
4MG
4MG
4MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A076972
A077541
A077011
A076780
A077548
A077387
A079032
A078244
A077551
A077173
A078014
A076759
A077716

001
001
001
001
001
001
001
001
001
001
001
001
001

Dec
Dec
Dec
Dec
Dec
Dec
Nov
Apr
Jun
Dec
Mar
Nov
Dec

26,
26,
26,
26,
26,
26,
18,
23,
27,
26,
21,
22,
26,

2006
2006
2006
2006
2006
2006
2008
2008
2007
2006
2008
2006
2006

N020007 001

Jan 04, 1991

N020007 003

Dec 10, 1993

A091483
A078127
A078776
A076960
A091342
A077009

Jan
Jun
Nov
Dec
Jan
Nov

001
001
001
001
001
001

31,
25,
28,
26,
27,
30,

2011
2007
2007
2006
2011
2007

4MG BASE/5ML

N020605 001

Jan 24, 1997

4MG BASE
8MG BASE
4MG BASE
8MG BASE
24MG BASE
4MG BASE
8MG BASE
24MG BASE
4MG BASE
8MG BASE
24MG BASE
4MG BASE
8MG BASE
24MG BASE
4MG BASE
8MG BASE
4MG BASE
8MG BASE
24MG BASE
4MG BASE
8MG BASE
24MG BASE
4MG BASE
8MG BASE
24MG BASE
4MG BASE
8MG BASE
4MG BASE

A077306
A077306
A078539
A078539
A078539
A076183
A076183
A076183
A077535
A077535
A077535
A076930
A076930
A076930
A077851
A077851
A077303
A077303
A077303
A077112
A077112
A077112
A077517
A077517
A077517
A077050
A077050
A077729

Jun
Jun
Jul
Jul
Jul
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Mar

001
002
001
002
003
003
002
001
001
002
003
001
002
004
001
002
001
002
004
001
002
003
001
002
003
001
002
001

25,
25,
31,
31,
31,
26,
26,
26,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
28,

2007
2007
2007
2007
2007
2006
2006
2006
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 320 (of 424)

ONDANSETRON HYDROCHLORIDE
TABLET; ORAL
ONDANSETRON HYDROCHLORIDE
TARO
EQ
AB
EQ
AB
TEVA
EQ
AB
EQ
AB
EQ
AB
WEST WARD
EQ
AB
EQ
AB
EQ
AB
ZOFRAN
GLAXOSMITHKLINE
EQ
AB
AB
EQ
AB +
EQ
ONDANSETRON HYDROCHLORIDE
DR REDDYS LABS LTD
EQ
XX

002
003
001
002
003
001
002
003

Mar
Mar
Jun
Jun
Jun
Sep
Sep
Sep

28,
28,
25,
25,
25,
06,
06,
06,

2011
2011
2007
2007
2007
2007
2007
2007

8MG BASE
24MG BASE
4MG BASE
8MG BASE
24MG BASE
4MG BASE
8MG BASE
24MG BASE

A077729
A077729
A076252
A076252
A076252
A077545
A077545
A077545

4MG BASE
8MG BASE
24MG BASE

N020103 001
N020103 002
N020103 003

Dec 31, 1992

Dec 31, 1992
Aug 27, 1999

16MG BASE

A076559 001

Dec 26, 2006

120MG

N020766 001

Apr 23, 1999

30MG/ML

N013055 001

30MG/ML
30MG/ML
30MG/ML
30MG/ML
30MG/ML

A040484
A040463
A090585
A084779
A087062

001
001
001
001
001

May
Mar
Aug
Mar

24,
04,
30,
15,

2006
2003
2011
1982

100MG
100MG
100MG
100MG

A040284
A040368
A040249
A040327

001
001
001
001

Jun
Jun
Jan
Feb

19,
23,
29,
15,

1998
2000
1999
2000

CAPSULE; ORAL
TAMIFLU
ROCHE
XX
XX
XX +

EQ 30MG BASE
EQ 45MG BASE
EQ 75MG BASE

N021087 003
N021087 002
N021087 001

Jul 02, 2007

Jul 02, 2007
Oct 27, 1999

FOR SUSPENSION; ORAL

TAMIFLU
ROCHE
XX

EQ 6MG BASE/ML

N021246 002

Mar 21, 2011

EQ
EQ
EQ
EQ
EQ

A061490
A062737
A061490
A062737
A061490

ORLISTAT
CAPSULE; ORAL

XENICAL

XX + HOFFMANN LA ROCHE

ORPHENADRINE CITRATE

AP
AP
AP
AP
AP
AP

AB
AB
AB
AB

INJECTABLE; INJECTION
NORFLEX
+ MEDICIS
ORPHENADRINE CITRATE
AKORN
BEDFORD LABS
SAGENT PHARMS
WATSON LABS
TABLET, EXTENDED RELEASE;
ORPHENADRINE CITRATE
GAVIS PHARMS
IMPAX PHARMS
KIEL
+ SANDOZ

ORAL

OSELTAMIVIR PHOSPHATE

OXACILLIN SODIUM
INJECTABLE; INJECTION
OXACILLIN SODIUM
AP + SANDOZ
AP
AP +
AP
AP +

1GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL

003
001
004
002
006

Dec 23, 1986

Dec 23, 1986
May 09, 1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 321 (of 424)

OXACILLIN SODIUM
INJECTABLE; INJECTION

BACTOCILL IN PLASTIC CONTAINER

EQ 20MG BASE/ML
XX + BAXTER HLTHCARE
EQ 40MG BASE/ML
XX +

N050640 001
N050640 002

Oct 26, 1989

Oct 26, 1989

N021759 001
N021759 002

Jan 31, 2005

Jan 31, 2005

A078819
A078819
A078812
A078812
A078811
A078811
A078810
A078810
A078815
A078815
A078813
A078813
A078817
A090849
A078817
A090849
A078818
A078818
N022160
N022160

Jun
Jun
Aug
Aug
Jun
Jun
Aug
Aug
Sep
Sep
Aug
Aug
Jan
Apr
Jan
Apr
Aug
Aug
Aug
Aug

OXALIPLATIN
INJECTABLE; IV (INFUSION)
ELOXATIN
AP + SANOFI AVENTIS US
50MG/10ML (5MG/ML)
AP +
100MG/20ML (5MG/ML)
OXALIPLATIN
APP PHARMS
AP
50MG/VIAL
AP
100MG/VIAL
EBEWE PHARMA
AP
50MG/10ML (5MG/ML)
AP
100MG/20ML (5MG/ML)
FRESENIUS KABI ONCOL 50MG/10ML (5MG/ML)
AP
AP
100MG/20ML (5MG/ML)
AP
50MG/VIAL
AP
100MG/VIAL
HOSPIRA INC
AP
50MG/VIAL
AP
100MG/VIAL
HOSPIRA WORLDWIDE
AP
50MG/10ML (5MG/ML)
AP
100MG/20ML (5MG/ML)
SANDOZ
AP
50MG/10ML (5MG/ML)
AP
50MG/VIAL
AP
100MG/20ML (5MG/ML)
AP
100MG/VIAL
AP + SUN PHARMA GLOBAL
50MG/VIAL
AP +
100MG/VIAL
TEVA PARENTERAL
AP
50MG/10ML (5MG/ML)
AP
100MG/20ML (5MG/ML)
ELOXATIN
200MG/40ML (5MG/ML)
XX + SANOFI AVENTIS US

001
002
001
002
001
002
001
002
001
002
001
002
001
001
002
002
001
002
001
002

02,
02,
07,
07,
10,
10,
07,
07,
30,
30,
07,
07,
24,
28,
24,
28,
07,
07,
07,
07,

2010
2010
2009
2009
2010
2010
2009
2009
2009
2009
2009
2009
2011
2011
2011
2011
2009
2009
2009
2009

N021759 003

Nov 17, 2006

2.5MG
10MG

N013718 001
N013718 002

Nov 05, 2001

2.5MG
10MG
2.5MG
10MG
2.5MG
10MG

A077827
A077827
A076897
A076897
A076761
A078033

Jun
Jun
Dec
Dec
Dec
Mar

600MG

N018841 004

Oct 29, 1992

600MG
600MG
600MG
600MG
600MG
600MG
600MG

A075987
A075844
A075855
A075846
A075847
A075845
A075849

Sep
Jan
Jan
May
Feb
Jan
Jul

OXANDROLONE
TABLET; ORAL
OXANDRIN
SAVIENT PHARMS
AB
AB +
OXANDROLONE
PAR PHARM
AB
AB
SANDOZ
AB
AB
UPSHER SMITH
AB
AB

001
002
001
002
001
001

22,
22,
01,
01,
01,
22,

2007
2007
2006
2006
2006
2007

OXAPROZIN

AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
DAYPRO
+ GD SEARLE
OXAPROZIN
APOTEX INC
CARACO
DR REDDYS LABS LTD
IVAX SUB TEVA PHARMS
MYLAN
SANDOZ
TEVA

001
001
001
001
001
001
001

02,
03,
31,
13,
28,
31,
03,

2004
2002
2001
2002
2001
2001
2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 322 (of 424)

OXAPROZIN
TABLET; ORAL
OXAPROZIN
WATSON LABS
AB

600MG

A075848 001

Feb 09, 2001

10MG
15MG
30MG
10MG
15MG
30MG
10MG
15MG
30MG
10MG
15MG
30MG

A072251
A072252
A072253
A070943
A070944
A070945
A071813
A071756
A071814
A072952
A072953
A072954

Apr
Apr
Apr
Aug
Aug
Aug
Apr
Apr
Apr
Sep
Sep
Sep

300MG/5ML

A078734 001

Jun 26, 2009

300MG/5ML

N021285 001

May 25, 2001

150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
600MG

A077747
A077747
A077747
A078069
A078069
A078069
A090239
A090239
A090239
A077802
A077802
A077802
A077795
A077795
A077795
A077794
A077794
A077794
A077801
A077801
A077801
A078005
A078005
A078005

Apr
Apr
Apr
Jan
Jan
Jan
Jan
Jan
Jan
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Nov
Nov
Nov
Dec
Dec
Dec

150MG
300MG
600MG

N021014 001
N021014 002
N021014 003

OXAZEPAM
CAPSULE; ORAL
OXAZEPAM
ACTAVIS ELIZABETH
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB +
SANDOZ
AB
AB
AB
WATSON LABS
AB
AB
AB

001
001
001
001
001
001
001
001
001
001
001
001

14,
14,
14,
03,
03,
03,
19,
19,
19,
28,
28,
28,

1988
1988
1988
1987
1987
1987
1988
1988
1988
1990
1990
1990

OXCARBAZEPINE
SUSPENSION; ORAL
OXCARBAZEPINE
RANBAXY
AB
TRILEPTAL
AB + NOVARTIS
TABLET; ORAL
OXCARBAZEPINE
APOTEX INC
AB
AB
AB
BRECKENRIDGE PHARM
AB
AB
AB
CADISTA PHARMS
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
ROXANE
AB
AB
AB
SUN PHARM INDS
AB
AB
AB
TARO
AB
AB
AB
TEVA PHARMS
AB
AB
AB
TRILEPTAL
NOVARTIS
AB
AB
AB +

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

09,
09,
09,
11,
11,
11,
25,
25,
25,
09,
09,
09,
09,
09,
09,
09,
09,
09,
15,
15,
15,
11,
11,
11,

2008
2008
2008
2008
2008
2008
2010
2010
2010
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007

Jan 14, 2000

Jan 14, 2000
Jan 14, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 323 (of 424)

OXICONAZOLE NITRATE
CREAM; TOPICAL

OXISTAT

XX + ALTANA

EQ 1% BASE

N019828 001

Dec 30, 1988

LOTION; TOPICAL

OXISTAT

XX + FOUGERA PHARMS

EQ 1% BASE

N020209 001

Sep 30, 1992

A087863 001
A086742 001

May 24, 1983

FILM, EXTENDED RELEASE; TRANSDERMAL

OXYTROL

3.9MG/24HR
XX + WATSON LABS (UTAH)

N021351 002

Feb 26, 2003

GEL, METERED; TRANSDERMAL

ANTUROL

XX + ANTARES PHARMA INC

3%

N202513 001

Dec 07, 2011

10%(100MG/PACKET)

N022204 001

Jan 27, 2009

5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML
5MG/5ML

A075039
A074997
A075137
A074520
A076682
A074868

Jan
Oct
Dec
Mar
Dec
Feb

5MG

N017577 001

5MG
5MG
5MG

A071655 001
A074625 001
A075079 001

Nov 14, 1988

Jul 31, 1996
Oct 31, 1997

N020897 001
N020897 002
N020897 003

Dec 16, 1998

Dec 16, 1998
Jun 22, 1999

A076745
A076745
A076745
A076702
A076644
A078293
A078503
A078503
A078503

May
May
Nov
Nov
Nov
May
Feb
Feb
Feb

OXTRIPHYLLINE
TABLET, EXTENDED RELEASE; ORAL

CHOLEDYL SA

400MG
XX + WARNER CHILCOTT
600MG
XX +

OXYBUTYNIN

OXYBUTYNIN CHLORIDE
GEL; TRANSDERMAL

GELNIQUE

XX + WATSON LABS

AA
AA
AA
AA
AA
AA

AB
AB
AB
AB

SYRUP; ORAL
OXYBUTYNIN CHLORIDE
MIKART
NOVEX
PHARM ASSOC
SILARX
VINTAGE PHARMS
+ WOCKHARDT
TABLET; ORAL
DITROPAN
+ JANSSEN PHARMS
OXYBUTYNIN CHLORIDE
PLIVA
USL PHARMA
VINTAGE PHARMS

TABLET, EXTENDED RELEASE; ORAL

DITROPAN XL
JANSSEN PHARMS
AB
5MG
AB
10MG
AB +
15MG
OXYBUTYNIN CHLORIDE
IMPAX PHARMS
AB
5MG
AB
10MG
AB
15MG
MYLAN
AB
5MG
AB
10MG
AB
15MG
OSMOTICA PHARM
AB
5MG
AB
10MG
AB
15MG

001
001
001
001
001
001

002
003
001
001
001
001
001
002
003

29,
15,
18,
29,
28,
12,

09,
09,
09,
09,
09,
10,
04,
04,
04,

1999
1997
1998
1996
2004
1997

2007
2007
2006
2006
2006
2007
2009
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 324 (of 424)

OXYCODONE HYDROCHLORIDE
CAPSULE; ORAL

OXYCODONE HYDROCHLORIDE

5MG
XX + LEHIGH VALLEY

N200534 001

Oct 20, 2010

SOLUTION; ORAL

OXYCODONE HYDROCHLORIDE

100MG/5ML
XX + LEHIGH VALLEY

N200535 001

Oct 20, 2010

A076636
A076636
A202116
A202116
A202116
A091393
A091393
A091393
A091393
A091393
A091313
A091313
A091313
A090895
A090895
A090895
A076758
A076758
A078206
A077290
A077290
A077290
A077290
A077290
A091490
A091490
A091490
A091490
A091490
A090659
A090659
A090659
A077712
A077712
A077712

Feb
Feb
Dec
Dec
Dec
Aug
Aug
Aug
Aug
Aug
Feb
Feb
Feb
Aug
Aug
Aug
Jun
Jun
Mar
Dec
Dec
Dec
Dec
Dec
Mar
Mar
Mar
Mar
Mar
Apr
Apr
Apr
Mar
Jan
Jan

TABLET; ORAL
OXYCODONE HYDROCHLORIDE
ACTAVIS TOTOWA
15MG
AB
30MG
AB
ALVOGEN INC
5MG
AB
15MG
AB
30MG
AB
AVANTHI INC
5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
COASTAL PHARMS
5MG
AB
15MG
AB
30MG
AB
COREPHARMA
5MG
AB
15MG
AB
30MG
AB
MALLINCKRODT
15MG
AB
30MG
AB
MALLINCKRODT INC
5MG
AB
NESHER PHARMS
5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
RHODES PHARMS
5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
SUN PHARM INDS INC
5MG
AB
15MG
AB
30MG
AB
VINTAGE PHARMS
5MG
AB
15MG
AB
30MG
AB
ROXICODONE
XANODYNE PHARMS
AB
5MG
AB +
15MG
AB
30MG
OXECTA
KING PHARMS R AND D
5MG
XX
7.5MG
XX

N021011 003
N021011 001
N021011 002

May 15, 2009

Aug 31, 2000
Aug 31, 2000

N202080 001
N202080 002

Jun 17, 2011

Jun 17, 2011

TABLET, EXTENDED RELEASE; ORAL

OXYCONTIN
PURDUE PHARMA LP
10MG
XX
15MG
XX
20MG
XX
30MG
XX
40MG
XX +
60MG
XX
80MG
XX

N022272
N022272
N022272
N022272
N022272
N022272
N022272

Apr
Apr
Apr
Apr
Apr
Apr
Apr

001
002
001
002
003
001
002
003
004
005
001
002
003
001
002
003
001
002
001
001
002
003
004
005
001
002
003
004
005
001
002
003
003
001
002

001
002
003
004
005
006
007

06,
06,
30,
30,
30,
31,
31,
31,
31,
31,
18,
18,
18,
24,
24,
24,
30,
30,
19,
08,
08,
08,
08,
08,
09,
09,
09,
09,
09,
10,
10,
10,
02,
31,
31,

05,
05,
05,
05,
05,
05,
05,

2004
2004
2011
2011
2011
2009
2009
2009
2009
2009
2011
2011
2011
2009
2009
2009
2004
2004
2007
2005
2005
2005
2005
2005
2011
2011
2011
2011
2011
2009
2009
2009
2009
2007
2007

2010
2010
2010
2010
2010
2010
2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 325 (of 424)

OXYMETHOLONE
TABLET; ORAL

ANADROL-50

XX + MEDA PHARMS

50MG

N016848 001

1MG/ML

N011707 002

OXYMORPHONE HYDROCHLORIDE
INJECTABLE; INJECTION

OPANA

XX + ENDO PHARMS

AB
AB
AB
AB
AB
AB

TABLET; ORAL
OPANA
ENDO PHARMS
5MG
+
10MG
OXYMORPHONE HYDROCHLORIDE
ROXANE
5MG
10MG
TEVA
5MG
10MG

TABLET, EXTENDED RELEASE; ORAL

OPANA ER
ENDO PHARMS
AB
5MG
AB
10MG
AB
20MG
AB
30MG
AB +
40MG
OXYMORPHONE HYDROCHLORIDE
ACTAVIS
AB
7.5MG
AB
15MG
IMPAX LABS
AB
5MG
AB
7.5MG
AB
10MG
AB
15MG
AB
20MG
AB
30MG
AB
40MG
OPANA ER
ENDO PHARMS
5MG
XX
7.5MG
XX
10MG
XX
15MG
XX
20MG
XX
30MG
XX
40MG
XX

N021611 001
N021611 002

Jun 22, 2006

Jun 22, 2006

A090964
A090964
A091443
A091443

001
002
002
001

Sep
Sep
Feb
Feb

27,
27,
15,
15,

2010
2010
2011
2011

N021610
N021610
N021610
N021610
N021610

001
002
003
007
004

Jun
Jun
Jun
Feb
Jun

22,
22,
22,
29,
22,

2006
2006
2006
2008
2006

A079046
A079046
A079087
A079087
A079087
A079087
A079087
A079087
A079087

001
002
001
002
003
004
005
006
007

Dec
Dec
Jun
Dec
Jun
Dec
Jun
Jul
Jun

13,
13,
14,
21,
14,
21,
14,
22,
14,

2010
2010
2010
2010
2010
2010
2010
2010
2010

N201655
N201655
N201655
N201655
N201655
N201655
N201655

001
002
003
004
005
006
007

Dec
Dec
Dec
Dec
Dec
Dec
Dec

09,
09,
09,
09,
09,
09,
09,

2011
2011
2011
2011
2011
2011
2011

OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC

TERRAMYCIN W/ POLYMYXIN B SULFATE

EQ 5MG BASE/GM;10,000 UNITS/GM

XX + PFIZER

A061015 001

OXYTOCIN

AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
OXYTOCIN
+ APP PHARMS
+
+ BAXTER HLTHCARE CORP
+
TEVA PARENTERAL

10USP UNITS/ML (10USP UNITS/ML)

100USP UNITS/10ML (10USP UNITS/ML)
10USP UNITS/ML (10USP UNITS/ML)
100USP UNITS/10ML (10USP UNITS/ML)
10USP UNITS/ML (10USP UNITS/ML)
100USP UNITS/10ML (10USP UNITS/ML)

N018248
N018248
N018243
N018243
A077453
A077453

001
002
001
002
001
002

Jan 10, 2007

Jan 24, 2008
Jan 24, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 326 (of 424)

OXYTOCIN
INJECTABLE; INJECTION
PITOCIN
AP + JHP PHARMS
AP
OXYTOCIN
XX + APP PHARMS

10USP UNITS/ML (10USP UNITS/ML)

100USP UNITS/10ML (10USP UNITS/ML)

N018261 001
N018261 002

Jul 27, 2007

300USP UNITS/30ML (10USP UNITS/ML)

N018248 003

Jul 27, 2007

N021660 001

Jan 07, 2005

A075436
A090130
A075190
A078167
A077574
A076131
A075278
A091540
A075184

001
001
001
001
001
001
001
001
001

Nov
Dec
Jan
Dec
Nov
May
Jan
Sep
Jan

12,
09,
28,
26,
27,
08,
25,
29,
25,

2004
2009
2002
2007
2006
2002
2002
2011
2002

N021999
N021999
N021999
N021999

006
001
002
003

Aug
Dec
Dec
Dec

26,
19,
19,
19,

2008
2006
2006
2006

N022264
N022264
N022264
N022264
N022264

001
002
003
004
005

Jul
Jul
Jul
Jul
Jul

31,
31,
31,
31,
31,

2009
2009
2009
2009
2009

PACLITAXEL
FOR SUSPENSION; IV (INFUSION)

ABRAXANE

XX + ABRAXIS BIOSCIENCE
100MG/VIAL

AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
PACLITAXEL
ACCORD HLTHCARE INC
ACTAVIS TOTOWA
BEDFORD
EBEWE PHARMA
FRESENIUS KABI ONCOL
+ HOSPIRA
MYLAN
ONCO THERAPIES LTD
TEVA PARENTERAL

6MG/ML
6MG/ML
6MG/ML
6MG/ML
6MG/ML
6MG/ML
6MG/ML
6MG/ML
6MG/ML

PALIPERIDONE
TABLET, EXTENDED RELEASE; ORAL
INVEGA
JANSSEN PHARMS
1.5MG
XX
3MG
XX
6MG
XX +
9MG
XX

PALIPERIDONE PALMITATE
SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
INVEGA SUSTENNA
JANSSEN PHARMS
39MG/0.25ML (39MG/0.25ML)
XX
78MG/0.5ML (78MG/0.5ML)
XX
117MG/0.75ML (117MG/0.75ML)
XX +
156MG/ML (156MG/ML)
XX
234MG/1.5ML (156MG/ML)
XX

PALONOSETRON HYDROCHLORIDE
INJECTABLE; INTRAVENOUS

ALOXI

XX + HELSINN HLTHCARE
XX

EQ 0.075MG BASE/1.5ML (EQ 0.05MG

BASE/ML)
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

N021372 002

Feb 29, 2008

N021372 001

Jul 25, 2003

30MG/VIAL

N020036 001

Oct 31, 1991

30MG/VIAL
30MG/10ML (3MG/ML)
90MG/VIAL
90MG/10ML (9MG/ML)
30MG/VIAL
60MG/VIAL

A075773
A076207
A075773
A076207
A077433
A077433

May
May
May
May
Nov
Nov

PAMIDRONATE DISODIUM
INJECTABLE; INJECTION
AREDIA
AP + NOVARTIS
PAMIDRONATE DISODIUM
APP PHARMS
AP
AP
AP
AP
AREVA PHARMS
AP
AP

001
001
002
002
001
002

06,
17,
06,
17,
26,
26,

2002
2002
2002
2002
2008
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 327 (of 424)

PAMIDRONATE DISODIUM
INJECTABLE; INJECTION
PAMIDRONATE DISODIUM
AREVA PHARMS
AP
BEDFORD
AP
AP +
AP
AP +
AP + HOSPIRA
AP +
AP +
LUITPOLD
AP
AP
MN PHARMS
AP
AP
MUSTAFA NEVZAT
AP
AP
PFIZER
AP
AP
PLIVA LACHEMA
AP
AP
AP
SUN PHARMA GLOBAL
AP
AP
TEVA PARENTERAL
AP
AP

90MG/VIAL
30MG/VIAL
30MG/10ML
90MG/VIAL
90MG/10ML
30MG/10ML
60MG/10ML
90MG/10ML
30MG/10ML
90MG/10ML
30MG/VIAL
90MG/VIAL
30MG/10ML
90MG/10ML
30MG/10ML
90MG/10ML
30MG/10ML
60MG/10ML
90MG/10ML
30MG/VIAL
90MG/VIAL
30MG/10ML
90MG/10ML

(3MG/ML)
(9MG/ML)
(3MG/ML)
(6MG/ML)
(9MG/ML)
(3MG/ML)
(9MG/ML)

(3MG/ML)
(9MG/ML)
(3MG/ML)
(9MG/ML)
(3MG/ML)
(6MG/ML)
(9MG/ML)

(3MG/ML)
(9MG/ML)

A077433
A075290
N021113
A075290
N021113
A075841
A075841
A075841
A078942
A078942
A078300
A078300
A078373
A078373
A078520
A078520
A078156
A078156
A078156
A077703
A077703
A076153
A076153

003
001
001
003
002
001
002
003
001
002
001
002
001
002
001
002
001
002
003
001
002
001
002

Nov
Apr
Mar
Apr
Mar
Jun
Jun
Jun
Jul
Jul
Mar
Mar
Dec
Dec
Oct
Oct
Aug
Aug
Aug
Dec
Dec
Mar
Mar

26,
30,
04,
30,
04,
27,
27,
27,
25,
25,
10,
10,
23,
23,
31,
31,
19,
19,
19,
24,
24,
27,
27,

2008
2001
2002
2001
2002
2002
2002
2002
2008
2008
2009
2009
2008
2008
2008
2008
2008
2008
2008
2008
2008
2002
2002

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE, DELAYED RELEASE; ORAL
CREON
ABBOTT PRODS
30,000USP UNITS;6,000USP
XX
UNITS;19,000USP UNITS
60,000USP UNITS;12,000USP
XX
UNITS;38,000USP UNITS
120,000USP UNITS;24,000USP
XX +
UNITS;76,000USP UNITS
PANCREAZE
JANSSEN PHARMS
17,500USP/ UNITS;4,200USP/
XX
UNITS;10,000USP/ UNITS
43,750USP/ UNITS;10,500USP/
XX
UNITS;25,000USP/ UNITS
70,000USP/ UNITS;16,800USP/
XX
UNITS;40,000USP/ UNITS
61,000USP/ UNITS;21,000USP/
XX +
UNITS;37,000USP/ UNITS
ZENPEP
APTALIS PHARMA US
27,000USP UNITS;5,000USP
XX
UNITS;17,000USP UNITS
55,000USP UNITS;10,000USP
XX
UNITS;34,000USP UNITS
82,000USP UNITS;15,000USP
XX
UNITS;51,000USP UNITS
109,000USP UNITS;20,000USP
XX +
UNITS;68,000USP UNITS

N020725 001

Apr 30, 2009

N020725 002

Apr 30, 2009

N020725 003

Apr 30, 2009

N022523 001

Apr 12, 2010

N022523 002

Apr 12, 2010

N022523 004

Apr 12, 2010

N022523 003

Apr 12, 2010

N022210 001

Aug 27, 2009

N022210 002

Aug 27, 2009

N022210 003

Aug 27, 2009

N022210 004

Aug 27, 2009

A072320 001
A072759 001
A072760 001

Jan 19, 1989

Jul 31, 1990
Jul 31, 1990

PANCURONIUM BROMIDE
INJECTABLE; INJECTION
PANCURONIUM BROMIDE
HOSPIRA
AP
AP + TEVA PARENTERAL
AP +

1MG/ML
1MG/ML
2MG/ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 328 (of 424)

PANTOPRAZOLE SODIUM
FOR SUSPENSION, DELAYED RELEASE; ORAL

PROTONIX

EQ 40MG BASE
XX + WYETH PHARMS INC

N022020 001

Nov 14, 2007

INJECTABLE; IV (INFUSION)

PROTONIX IV

XX + WYETH PHARMS INC

EQ 40MG BASE/VIAL

N020988 001

Mar 22, 2001

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A090797
A090797
A077619
A077619
A090901
A090901
A078281
A078281
A090970
A090970
A077058
A077058
A077056
A077056
A090074
A090074
A091231
A091231

Feb
Feb
Jan
Jan
Aug
Aug
Jan
Jan
Jan
Jan
Sep
Sep
Aug
Aug
Jan
Jan
Jan
Jan

BASE
BASE

N020987 002
N020987 001

Jun 12, 2001

Feb 02, 2000

1MCG
2MCG
4MCG

N021606 001
N021606 002
N021606 003

May 26, 2005

May 26, 2005
May 26, 2005

0.002MG/ML
0.005MG/ML

A091108 001
A091108 002

Jul 27, 2011

Jul 27, 2011

0.002MG/ML
0.005MG/ML

N020819 002
N020819 001

Feb 01, 2000

Apr 17, 1998

EQ 250MG BASE
EQ 250MG BASE

A064171 001
A065173 001

Jun 30, 1997

Dec 14, 2007

A077395 001

Dec 05, 2006

N020710 001

Jun 25, 1997

TABLET, DELAYED RELEASE; ORAL

PANTOPRAZOLE SODIUM
ACTAVIS TOTOWA
AB
EQ 20MG
AB
EQ 40MG
DR REDDYS LABS LTD
AB
EQ 20MG
AB
EQ 40MG
JUBILANT ORGANOSYS
AB
EQ 20MG
AB
EQ 40MG
KUDCO IRELAND
AB
EQ 20MG
AB
EQ 40MG
MATRIX LABS LTD
AB
EQ 20MG
AB
EQ 40MG
SUN PHARMA GLOBAL
AB
EQ 20MG
AB
EQ 40MG
TEVA
AB
EQ 20MG
AB
EQ 40MG
TORRENT PHARMS
AB
EQ 20MG
AB
EQ 40MG
WOCKHARDT
AB
EQ 20MG
AB
EQ 40MG
PROTONIX
WYETH PHARMS INC
AB
EQ 20MG
AB +
EQ 40MG

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

07,
07,
19,
19,
30,
30,
20,
20,
19,
19,
10,
10,
02,
02,
19,
19,
19,
19,

2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2007
2007
2007
2007
2011
2011
2011
2011

PARICALCITOL
CAPSULE; ORAL
ZEMPLAR
ABBOTT
XX
XX
XX +
INJECTABLE; INJECTION
PARICALCITOL
SANDOZ CANADA INC
AP
AP
ZEMPLAR
AP + ABBOTT
AP +

PAROMOMYCIN SULFATE
CAPSULE; ORAL
PAROMOMYCIN SULFATE
AA + CARACO
HERITAGE PHARMS INC
AA

PAROXETINE HYDROCHLORIDE
SUSPENSION; ORAL
PAROXETINE HYDROCHLORIDE
APOTEX INC
AB
EQ 10MG BASE/5ML
PAXIL
AB + GLAXOSMITHKLINE
EQ 10MG BASE/5ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 329 (of 424)

PAROXETINE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AB
AB
AB
AB
AB
AB

TABLET; ORAL
PAROXETINE HYDROCHLORIDE
ALPHAPHARM
EQ
EQ
EQ
EQ
APOTEX
EQ
EQ
EQ
EQ
AUROBINDO PHARMA
EQ
EQ
EQ
EQ
CARACO
EQ
EQ
EQ
EQ
MYLAN
EQ
EQ
EQ
EQ
TEVA
EQ
EQ
EQ
EQ
ZYDUS PHARMS USA
EQ
EQ
EQ
EQ
PAXIL
GLAXOSMITHKLINE
EQ
EQ
EQ
+
EQ

10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A075716
A075716
A075716
A075716
A075356
A075356
A075356
A075356
A078406
A078406
A078406
A078406
A078194
A078194
A078194
A078194
A078902
A078902
A078902
A078902
A076618
A076618
A076618
A076618
A077584
A077584
A077584
A077584

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Mar
Mar
Mar
Mar
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jun
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Aug
Aug
Aug
Aug
Mar
Mar
Mar
Mar

08,
08,
08,
08,
30,
30,
30,
30,
25,
25,
25,
25,
29,
29,
29,
29,
13,
13,
13,
13,
15,
15,
15,
15,
07,
07,
07,
07,

2004
2004
2004
2004
2003
2003
2003
2003
2007
2007
2007
2007
2007
2007
2007
2007
2008
2008
2008
2008
2005
2005
2005
2005
2007
2007
2007
2007

10MG
20MG
30MG
40MG

BASE
BASE
BASE
BASE

N020031
N020031
N020031
N020031

001
002
003
005

Dec
Dec
Dec
Dec

29,
29,
29,
29,

1992
1992
1992
1992

TABLET, EXTENDED RELEASE; ORAL

PAROXETINE HYDROCHLORIDE
MYLAN
EQ 12.5MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
PAXIL CR
GLAXOSMITHKLINE
EQ 12.5MG BASE
EQ 25MG BASE
+
EQ 37.5MG BASE

A077873 001
A077873 002
A091427 001

Jun 29, 2007

Jun 29, 2007
Apr 14, 2011

N020936 001
N020936 002
N020936 003

Feb 16, 1999

Feb 16, 1999
Dec 06, 2000

N021299
N021299
N021299
N021299

Jul
Jul
Jul
Jul

PAROXETINE MESYLATE
TABLET; ORAL
PEXEVA
NOVEN THERAP
XX
XX
XX
XX +

EQ
EQ
EQ
EQ

10MG
20MG
30MG
40MG

BASE
BASE
BASE
BASE

001
002
003
004

03,
03,
03,
03,

2003
2003
2003
2003

PAZOPANIB HYDROCHLORIDE
TABLET; ORAL
VOTRIENT
GLAXOSMITHKLINE
XX
XX +

EQ 200MG BASE
EQ 400MG BASE

N022465 001
N022465 002

Oct 19, 2009

Oct 19, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 330 (of 424)

PEGADEMASE BOVINE
INJECTABLE; INJECTION

ADAGEN

XX + SIGMA TAU

250 UNITS/ML

N019818 001

Mar 21, 1990

EQ 0.3MG ACID/0.09ML

N021756 001

Dec 17, 2004

10MG/VIAL
15MG/VIAL
20MG/VIAL

N021106 001
N021106 002
N021106 003

Mar 25, 2003

Mar 25, 2003
Mar 25, 2003

N021462 002
N021462 001

Sep 07, 2007

Feb 04, 2004

N021079 001

Sep 24, 1999

20MG

N018976 004

Jan 05, 1989

1%

N020629 001

Sep 24, 1996

CAPSULE; ORAL

CUPRIMINE

XX + ATON

250MG

N019853 001

TABLET; ORAL

DEPEN

XX + MEDA PHARMS

250MG

N019854 001

600,000 UNITS/ML

N050141 001

600,000 UNITS/ML

A060014 001

300,000 UNITS/ML

N050141 003

PEGAPTANIB SODIUM
INJECTABLE; INTRAVITREAL

MACUGEN

XX + EYETECH INC

PEGVISOMANT
INJECTABLE; SUBCUTANEOUS

SOMAVERT

XX + PHARMACIA AND UPJOHN

XX +
XX +

PEMETREXED DISODIUM
INJECTABLE; IV (INFUSION)

ALIMTA

XX + LILLY

EQ 100MG BASE/VIAL
XX +

EQ 500MG BASE/VIAL

PEMIROLAST POTASSIUM
SOLUTION/DROPS; OPHTHALMIC

ALAMAST

0.1%
XX + SANTEN

PENBUTOLOL SULFATE
TABLET; ORAL

LEVATOL

XX + SCHWARZ PHARMA

PENCICLOVIR SODIUM
CREAM; TOPICAL

DENAVIR

XX + DENCO ASSET

PENICILLAMINE

PENICILLIN G BENZATHINE
INJECTABLE; INJECTION
BICILLIN L-A
BC + KING PHARMS
PERMAPEN
BC
PFIZER
BICILLIN L-A
XX + KING PHARMS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 331 (of 424)

PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE

INJECTABLE; INJECTION

BICILLIN C-R

XX + KING PHARMS
XX +
BICILLIN C-R 900/300

XX + KING PHARMS

150,000 UNITS/ML;150,000 UNITS/ML

300,000 UNITS/ML;300,000 UNITS/ML

N050138 002
N050138 001

900,000 UNITS/2ML;300,000 UNITS/2ML

N050138 003

PENICILLIN G POTASSIUM
INJECTABLE; INJECTION
PENICILLIN G POTASSIUM
APP PHARMS
AP
5,000,000 UNITS/VIAL
AP
20,000,000 UNITS/VIAL
HANFORD GC
AP
5,000,000 UNITS/VIAL
AP
20,000,000 UNITS/VIAL
SANDOZ
AP
5,000,000 UNITS/VIAL
AP
20,000,000 UNITS/VIAL
PFIZERPEN
AP + PFIZER
5,000,000 UNITS/VIAL
AP +
20,000,000 UNITS/VIAL
PENICILLIN G POTASSIUM
HANFORD GC
1,000,000 UNITS/VIAL
XX
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
20,000 UNITS/ML
XX + BAXTER HLTHCARE
40,000 UNITS/ML
XX +
60,000 UNITS/ML
XX +

A065448
A065448
A065149
A065149
A065079
A065079

001
002
002
003
002
003

Aug
Aug
Jul
Jul
Aug
Aug

18,
18,
23,
23,
30,
30,

2009
2009
2009
2009
2002
2002

A060657 002
A060657 003
A065149 001

Jul 23, 2009

N050638 001
N050638 002
N050638 003

Jun 25, 1990

Jun 25, 1990
Jun 25, 1990

PENICILLIN G PROCAINE
INJECTABLE; INJECTION

PENICILLIN G PROCAINE

XX + KING PHARMS
XX +

300,000 UNITS/ML
600,000 UNITS/ML

A060101 002
A060101 001

5,000,000 UNITS/VIAL

A065068 001

Feb 26, 2001

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

A062981 001
A062981 002

Feb 10, 1989

Feb 10, 1989

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

A060456 001
A060456 002

EQ
EQ
EQ
EQ
EQ
EQ

A065435
A065435
A062936
A062935
A064071
A064071

PENICILLIN G SODIUM
INJECTABLE; IM-IV

PENICILLIN G SODIUM

XX + SANDOZ

PENICILLIN V POTASSIUM
FOR SOLUTION; ORAL
PENICILLIN V POTASSIUM
DAVA PHARMS INC
AA
AA
PENICILLIN-VK
TEVA
AA
AA +
TABLET; ORAL
PENICILLIN V POTASSIUM
AUROBINDO PHARMA
AB
AB
DAVA PHARMS INC
AB
AB
SANDOZ
AB
AB +
PENICILLIN-VK
TEVA
AB
AB

250MG
500MG
250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE

EQ 250MG BASE
EQ 500MG BASE

001
002
001
001
001
002

A060711 002
A060711 003

Apr
Apr
Nov
Nov
Nov
Nov

29,
29,
25,
23,
30,
30,

2008
2008
1988
1988
1995
1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 332 (of 424)

PENTAMIDINE ISETHIONATE
FOR SOLUTION; INHALATION

NEBUPENT

XX + APP PHARMS

300MG/VIAL

N019887 001

Jun 15, 1989

INJECTABLE; INJECTION
PENTAM
AP + APP PHARMS
300MG/VIAL
PENTAMIDINE ISETHIONATE
WATSON LABS
AP
300MG/VIAL

N019264 001

Oct 16, 1984

A074303 001

Aug 17, 1995

PENTAZOCINE LACTATE
INJECTABLE; INJECTION

TALWIN

XX + HOSPIRA

EQ 30MG BASE/ML

N016194 001

50MG/ML

A083246 001

PENTOBARBITAL SODIUM
INJECTABLE; INJECTION

NEMBUTAL SODIUM

XX + LUNDBECK INC

PENTOSAN POLYSULFATE SODIUM

CAPSULE; ORAL

ELMIRON

XX + JANSSEN PHARMS

100MG

N020193 001

Sep 26, 1996

10MG/VIAL

N020122 001

Oct 11, 1991

10MG/VIAL

A077841 001

Aug 07, 2007

400MG
400MG
400MG
400MG
400MG
400MG

A075191
A075093
A074425
A074874
A075028
A075107

Jun
Aug
Jul
May
Jul
Sep

400MG

A074962 001

Mar 31, 1999

400MG

N018631 001

Aug 30, 1984

6.52MG/ML

N021064 001

Jul 31, 2001

2MG
4MG
8MG

N020184 001
N020184 002
N020184 003

Dec 30, 1993

Dec 30, 1993
Dec 30, 1993

2MG

A090463 001

Aug 30, 2010

PENTOSTATIN
INJECTABLE; INJECTION
NIPENT
AP + HOSPIRA INC
PENTOSTATIN
BEDFORD LABS
AP

PENTOXIFYLLINE

AB
AB
AB
AB
AB
AB
AB
AB

TABLET, EXTENDED RELEASE;

PENTOXIFYLLINE
APOTEX
IMPAX LABS
MYLAN
PLIVA
VALEANT INTL
WATSON LABS
PENTOXIL
UPSHER SMITH
TRENTAL
+ SANOFI AVENTIS US

ORAL
001
001
001
001
001
001

09,
10,
08,
25,
20,
04,

1999
1999
1997
1999
1998
1998

PERFLUTREN
INJECTABLE; INTRAVENOUS

DEFINITY

XX + LANTHEUS MEDCL

PERINDOPRIL ERBUMINE
TABLET; ORAL
ACEON
ABBOTT PRODS
AB
AB
AB +
PERINDOPRIL ERBUMINE
APOTEX
AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 333 (of 424)

PERINDOPRIL ERBUMINE
TABLET; ORAL
PERINDOPRIL ERBUMINE
APOTEX
AB
AB
AUROBINDO PHARMA
AB
AB
AB
IVAX PHARMS
AB
AB
AB
LUPIN LTD
AB
AB
AB
ROXANE
AB
AB
AB

002
003
001
002
003
001
002
003
001
002
003
001
002
003

Aug
Aug
Nov
Nov
Nov
Nov
Nov
Nov
Jan
Jan
Jan
Nov
Nov
Nov

30,
30,
10,
10,
10,
10,
10,
10,
27,
27,
27,
10,
10,
10,

2010
2010
2009
2009
2009
2009
2009
2009
2010
2010
2010
2009
2009
2009

4MG
8MG
2MG
4MG
8MG
2MG
4MG
8MG
2MG
4MG
8MG
2MG
4MG
8MG

A090463
A090463
A079070
A079070
A079070
A078138
A078138
A078138
A078263
A078263
A078263
A090072
A090072
A090072

5%

N019855 001

Aug 25, 1989

5%
5%

A074806 001
A076369 001

Jan 23, 1998

Apr 21, 2003

2MG
4MG
8MG
16MG
2MG
4MG
8MG
16MG

A089683
A089684
A089685
A089686
A040226
A040226
A040226
A040226

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

PERMETHRIN
CREAM; TOPICAL
ELIMITE
AB + ALLERGAN
PERMETHRIN
ACTAVIS MID ATLANTIC
AB
PERRIGO NEW YORK
AB

PERPHENAZINE
TABLET; ORAL
PERPHENAZINE
SANDOZ
AB
AB
AB
AB +
VINTAGE PHARMS
AB
AB
AB
AB

001
001
001
001
001
002
003
004

08,
08,
08,
08,
31,
31,
31,
31,

1988
1988
1988
1988
1998
1998
1998
1998

PHENDIMETRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE; ORAL
BONTRIL
BC
VALEANT
105MG
PHENDIMETRAZINE TARTRATE
BC + SANDOZ
105MG

AA
AA
AA
AA
AA

TABLET; ORAL
BONTRIL PDM
+ VALEANT
35MG
PHENDIMETRAZINE TARTRATE
KVK TECH
35MG
MIKAH PHARMA
35MG
MIKART
35MG
SANDOZ
35MG

A088021 001

Sep 21, 1982

N018074 001

A085272 001
A091042
A040762
A089452
A085588

001
001
001
001

Aug 31, 2010

Jan 28, 2008
Oct 30, 1991

PHENELZINE SULFATE
TABLET; ORAL
NARDIL
AB + PARKE DAVIS
PHENELZINE SULFATE
NOVEL LABS INC
AB

EQ 15MG BASE

N011909 002

EQ 15MG BASE

A200181 001

Dec 08, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 334 (of 424)

PHENOXYBENZAMINE HYDROCHLORIDE
CAPSULE; ORAL

DIBENZYLINE

XX + WELLSPRING PHARM

10MG

N008708 001

PHENTERMINE HYDROCHLORIDE
CAPSULE; ORAL
ADIPEX-P
AA + TEVA
37.5MG
PHENTERMINE HYDROCHLORIDE
BARR
AA
15MG
AA
30MG
KVK TECH
AA
15MG
AA
30MG
AA
30MG
AA
37.5MG
LANNETT
AA
30MG
AA
30MG
LANNETT HOLDINGS INC 37.5MG
AA
MUTUAL PHARM
AA
30MG
AA + SANDOZ
15MG
AA +
30MG
AA +
30MG

AA
AA
AA
AA
AA
AA
AA
AA
AA
XX

TABLET; ORAL
ADIPEX-P
+ TEVA
37.5MG
PHENTERMINE HYDROCHLORIDE
ACTAVIS ELIZABETH
37.5MG
BARR
37.5MG
CARACO
37.5MG
ELITE LABS
37.5MG
KVK TECH
37.5MG
LANNETT
37.5MG
MUTUAL PHARM
37.5MG
VINTAGE PHARMS
37.5MG
PHENTERMINE HYDROCHLORIDE
+ SANDOZ
30MG

A088023 001

Aug 02, 1983

A090591
A090591
A040886
A040875
A040886
A040887
A087022
A091359
A201961
A040525
A087190
A086945
A087190

Mar
Mar
Mar
Mar
Mar
Apr
Feb
Jul
Jul
Oct

001
002
002
001
001
001
001
001
001
001
002
001
001

18,
18,
31,
21,
31,
24,
03,
16,
20,
23,

2010
2010
2008
2008
2008
2008
1983
2010
2011
2003

Jul 20, 1983

A085128 001
A040276
A090470
A040790
A200272
A040876
A040555
A040526
A040377

001
001
001
001
001
001
001
001

Nov
Aug
Aug
Jan
Mar
Apr
Oct
Jan

25,
31,
21,
31,
31,
15,
23,
04,

1998
2009
2007
2011
2008
2005
2003
2002

A088605 001

Sep 28, 1987

N202088 001
N202088 002

Jun 13, 2011

Jun 13, 2011

A040872 001
A040872 002

Jul 28, 2011

Jul 28, 2011

5MG/VIAL

A040235 001

Mar 11, 1998

5MG/VIAL

N008278 003

0.4MG/1.7ML

N022159 001

TABLET, ORALLY DISINTEGRATING; ORAL

SUPRENZA
CITIUS PHARMS
15MG
XX
30MG
XX +

PHENTERMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE; ORAL
PHENTERMINE RESIN COMPLEX
XX
LANNETT HOLDINGS INC EQ 15MG BASE
XX
EQ 30MG BASE

PHENTOLAMINE MESYLATE
INJECTABLE; INJECTION
PHENTOLAMINE MESYLATE
BEDFORD
AP
REGITINE
AP + NOVARTIS
ORAVERSE
XX + SEPTODONT HOLDING

May 09, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 335 (of 424)

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
VINTAGE
AA
5MG/5ML;6.25MG/5ML
PROMETH VC PLAIN
AA + ACTAVIS MID ATLANTIC 5MG/5ML;6.25MG/5ML
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
AMNEAL PHARMS
AA
5MG/5ML;6.25MG/5ML

A040654 001

Dec 07, 2006

A088761 001

Nov 08, 1984

A040902 001

Aug 25, 2009

PHENYTOIN
SUSPENSION; ORAL
DILANTIN-125
AB + PARKE DAVIS
PHENYTOIN
TARO
AB
VISTAPHARM
AB
AB
WOCKHARDT
AB

125MG/5ML

N008762 001

125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML

A040521
A040342
A040610
A040420

TABLET, CHEWABLE; ORAL

DILANTIN

XX + PFIZER PHARMS

50MG

A084427 001

001
001
001
001

Mar
Jan
Aug
Apr

08,
31,
18,
19,

2004
2001
2005
2002

Nov
Dec
Jun
Jun
Dec
Sep
Dec
Jan

12,
28,
30,
30,
11,
05,
18,
30,

2008
1998
2008
2008
2006
2006
2007
2008

PHENYTOIN SODIUM

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
DILANTIN
+ PARKE DAVIS
30MG EXTENDED
+
100MG EXTENDED
EXTENDED PHENYTOIN SODIUM
AMNEAL PHARMS NY
100MG EXTENDED
MYLAN
100MG EXTENDED
SUN PHARM INDS
200MG EXTENDED
300MG EXTENDED
SUN PHARM INDS (IN)
100MG EXTENDED
TARO
100MG EXTENDED
WOCKHARDT
30MG EXTENDED
WOCKHARDT USA
100MG EXTENDED
PHENYTEK
MYLAN
200MG EXTENDED
+
300MG EXTENDED

INJECTABLE; INJECTION
PHENYTOIN SODIUM
AP + BAXTER HLTHCARE
HOSPIRA
AP
AP
LUITPOLD
AP
X-GEN PHARMS
AP

A084349 001
A084349 002
A040765
A040298
A040731
A040731
A040621
A040684
A040759
A040732

001
001
001
002
001
001
001
001

A040298 002
A040298 003

Dec 06, 2001

Dec 06, 2001

50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML

A084307
A089521
A089744
A040781
A040573

Mar
Dec
Dec
Sep

1MG/0.5ML

A083722 001

1MG/0.5ML

A087954 001

Jul 25, 1983

10MG/ML

A087955 001

Jul 25, 1983

5MG

N010104 003

001
001
001
001
001

17,
18,
04,
13,

1987
1987
2007
2006

PHYTONADIONE
INJECTABLE; INJECTION
PHYTONADIONE
BP
INTL MEDICATION
VITAMIN K1
BP + HOSPIRA
VITAMIN K1
XX + HOSPIRA
TABLET; ORAL

MEPHYTON

XX + BIOVAIL TECHNOLOGIES

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 336 (of 424)

PILOCARPINE HYDROCHLORIDE
GEL; OPHTHALMIC

PILOPINE HS

XX + ALCON

4%

N018796 001

Oct 01, 1984

SOLUTION; OPHTHALMIC
ISOPTO CARPINE
ALCON RES
XX
XX
XX +

1%
2%
4%

N200890 001
N200890 002
N200890 003

Jun 22, 2010

Jun 22, 2010
Jun 22, 2010

A076746
A077248
A077248
A077220
A077220
A076963
A076963

Nov
Mar
Mar
Oct
May
Dec
Feb

AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
PILOCARPINE HYDROCHLORIDE
COREPHARMA
5MG
IMPAX LABS
5MG
7.5MG
LANNETT
5MG
7.5MG
ROXANE
5MG
7.5MG
SALAGEN
EISAI INC
5MG
+
7.5MG

001
001
002
001
002
001
002

16,
31,
31,
14,
06,
22,
27,

2004
2006
2006
2005
2009
2004
2007

N020237 001
N020237 002

Mar 22, 1994

Apr 18, 2003

1%

N021302 001

Dec 13, 2001

1MG
2MG

N017473 003
N017473 001

Aug 27, 1997

Jul 31, 1984

5MG
10MG
5MG
10MG

A074019
A074019
A074437
A074437

Sep
Sep
Feb
Feb

PIMECROLIMUS
CREAM; TOPICAL

ELIDEL

XX + VALEANT INTL

PIMOZIDE
TABLET; ORAL
ORAP
TEVA
XX
XX +

PINDOLOL
TABLET; ORAL
PINDOLOL
MYLAN
AB
AB +
WATSON LABS
AB
AB

001
002
001
002

03,
03,
27,
27,

1992
1992
1995
1995

PIOGLITAZONE HYDROCHLORIDE
TABLET; ORAL
ACTOS
TAKEDA PHARMS NA
XX
XX
XX +

EQ 15MG BASE
EQ 30MG BASE
EQ 45MG BASE

N021073 001
N021073 002
N021073 003

Jul 15, 1999

Jul 15, 1999
Jul 15, 1999

EQ
EQ
EQ
EQ

A065114
A065114
A065114
A065157

Nov
Nov
Nov
Jul

PIPERACILLIN SODIUM

XX
XX
XX
XX

INJECTABLE; INJECTION

PIPERACILLIN

+ ISTITUTO BIOCHIMICO
+
+
+

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

001
002
003
001

14,
14,
14,
12,

2003
2003
2003
2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 337 (of 424)

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
XX
XX
XX

INJECTABLE; INJECTION
PIPERACILLIN AND TAZOBACTAM
AUROBINDO PHARMA LTD EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
HOSPIRA INC
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
INSTITUTO BIOCHEMICO EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
SANDOZ
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
ZOSYN
+ WYETH PHARMS INC
EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
+
EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
+
EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
+
EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
ZOSYN IN PLASTIC CONTAINER
+ WYETH PHARMS INC
EQ 40MG BASE/ML;EQ 5MG BASE/ML
+
EQ 60MG BASE/ML;EQ 7.5MG BASE/ML
+
EQ 4GM BASE/100ML;EQ 500MG BASE/100ML

A065498
A065498
A065498
A065386
A065386
A065386
A065446
A065523
A065523
A065523
A090498
A065362
A065363
A065362
A065363
A065362
A065363

001
002
003
001
002
003
001
001
002
003
001
001
001
002
002
003
003

May
May
May
Sep
Sep
Sep
Sep
May
May
May
May
Oct
Oct
Oct
Oct
Oct
Oct

23,
23,
23,
15,
15,
15,
15,
31,
31,
31,
31,
21,
21,
21,
21,
21,
21,

2011
2011
2011
2009
2009
2009
2009
2011
2011
2011
2011
2010
2010
2010
2010
2010
2010

N050684
N050684
N050684
N050684

001
002
003
004

Oct
Oct
Oct
Oct

22,
22,
22,
22,

1993
1993
1993
1993

N050750 001
N050750 002
N050750 003

Feb 24, 1998

Feb 24, 1998
Feb 24, 1998

N020014 001

Nov 30, 1992

10MG
20MG

N018147 002
N018147 003

Apr 06, 1982

Apr 06, 1982

10MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
10MG
20MG
20MG

A073535
A074102
A074102
A074116
A074118
A074131
A074131
A074287
A074460
A074287
A074460

Mar
Jul
Jul
Jun
Jun
Dec
Dec
May
Sep
May
Sep

EQ 1MG BASE
EQ 2MG BASE
EQ 4MG BASE

N022363 001
N022363 002
N022363 003

PIRBUTEROL ACETATE
AEROSOL, METERED; INHALATION

MAXAIR

EQ 0.2MG BASE/INH
XX + MEDICIS

PIROXICAM

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
FELDENE
PFIZER
+
PIROXICAM
MUTUAL PHARM
MYLAN
NOSTRUM LABS
TEVA
WATSON LABS

001
001
002
001
001
001
002
001
001
002
002

12,
31,
31,
15,
15,
11,
11,
16,
29,
16,
29,

1993
1992
1992
1993
1993
1992
1992
1996
1995
1996
1995

PITAVASTATIN CALCIUM
TABLET; ORAL
LIVALO
KOWA CO
XX
XX
XX +

Aug 03, 2009

Aug 03, 2009
Aug 03, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 338 (of 424)

PLERIXAFOR
SOLUTION; SUBCUTANEOUS

MOZOBIL

XX + GENZYME

24MG/1.2ML (20MG/ML)

N022311 001

Dec 15, 2008

0.5%

N020529 001

Mar 13, 1997

0.5%

N019795 001

Dec 13, 1990

0.5%
0.5%

A075600 001
A090184 001

Jan 29, 2002

Jul 21, 2010

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

N021201 001
N021201 002

Mar 30, 2010

Mar 30, 2010

A076652 001

Jul 02, 2004

A077736 001
A077706 001
A077893 001

May 26, 2006

Sep 27, 2006
May 26, 2006

PODOFILOX
GEL; TOPICAL

CONDYLOX

XX + WATSON PHARMS
SOLUTION; TOPICAL
CONDYLOX
AT + WATSON PHARMS
PODOFILOX
PADDOCK LLC
AT
PRECISION DERMAT
AT

POLIDOCANOL
SOLUTION; INTRAVENOUS
ASCLERA
CHEMISCH FBRK KRSSLR
XX
XX +

POLYETHYLENE GLYCOL 3350

AA
AA
AA
AA

FOR SOLUTION; ORAL

GLYCOLAX
KREMERS URBAN PHARMS 17GM/SCOOPFUL
POLYETHYLENE GLYCOL 3350
BRECKENRIDGE PHARM
17GM/SCOOPFUL
NEXGEN PHARMA INC
17GM/SCOOPFUL
PADDOCK LLC
17GM/SCOOPFUL

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

FOR SOLUTION; ORAL
LAX-LYTE WITH FLAVOR PACKS
PADDOCK LLC
AA
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
BOT
NULYTELY
AA + BRAINTREE
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
BOT
NULYTELY-FLAVORED
AA + BRAINTREE
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
BOT
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE
MYLAN
AA
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
BOT
NOVEL LABS INC
AA
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/
BOT
TRILYTE
MEDA PHARMS
AA
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

A090019 001

May 27, 2009

A076491 001

Feb 05, 2004

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

SODIUM SULFATE
FOR SOLUTION; ORAL
CLENZ-LYTE
PADDOCK LLC
AA

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
BOT;22.74GM/BOT

A090769 001

Jun 07, 2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 339 (of 424)

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

SODIUM SULFATE ANHYDROUS
FOR SOLUTION; ORAL
COLYTE
AA + MEDA PHARMS
AA

AA

AA
AA

AA

AA
AA
AA

AA

XX

N018983 010

Jan 31, 1989

N018983 007

Jun 12, 1987

N018983 012

Oct 08, 1998

N018983 008

Nov 14, 1991

N018983 009

Nov 14, 1991

N019011 001

Jul 13, 1984

A090928 001
A090231 001

Jan 28, 2010

Jun 01, 2009

A090186 001

Jun 01, 2009

A090712 001

Feb 25, 2010

N019011 002

Jun 02, 1992

EQ 500,000 UNITS BASE/VIAL

A090110 001

Jun 29, 2011

EQ 500,000 U BASE/VIAL
EQ 500,000 U BASE/VIAL
EQ 500,000 U BASE/VIAL

A065372 001
A060716 001
A063000 001

Jan 10, 2008

227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G
M/BOT;21.5GM/BOT
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/
BOT;22.72GM/BOT

COLYTE WITH FLAVOR PACKS

+ MEDA PHARMS
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/
BOT;22.72GM/BOT
COLYTE-FLAVORED
+ MEDA PHARMS
227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G
M/BOT;21.5GM/BOT
+
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/
BOT;22.72GM/BOT
GOLYTELY
+ BRAINTREE
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
BOT;22.74GM/BOT
PEG 3350 AND ELECTROLYTES
MYLAN
236GM;2.97GM;6.74GM;5.86GM;22.74GM
NOVEL LABS INC
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
BOT;22.74GM/BOT
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/
BOT;22.72GM/BOT
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
PADDOCK LLC
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/
BOT;22.72GM/BOT
GOLYTELY
+ BRAINTREE
227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC
KET;5.53GM/PACKET;21.5GM/PACKET

POLYMYXIN B SULFATE

AP
AP
AP
AP

INJECTABLE; INJECTION
POLYMYCIN B SULFATE
SAGENT STRIDES
POLYMYXIN B SULFATE
APP PHARMS
+ BEDFORD
X GEN PHARMS

POWDER; FOR RX COMPOUNDING

POLY-RX

100,000,000 UNITS/BOT
XX + X GEN PHARMS

Sep 30, 1994

A061578 001

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
POLYTRIM
+ ALLERGAN
10,000 UNITS/ML;EQ 1MG
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
BAUSCH AND LOMB
10,000 UNITS/ML;EQ 1MG
FALCON PHARMS
10,000 UNITS/ML;EQ 1MG
TAYLOR PHARMA
10,000 UNITS/ML;EQ 1MG

BASE/ML

N050567 001

Oct 20, 1988

BASE/ML
BASE/ML
BASE/ML

A064120 001
A064211 001
A065006 001

Feb 14, 1997

Apr 13, 1998
Dec 17, 1998

N020744 001

Nov 18, 1999

N020451 001

Dec 27, 1995

PORACTANT ALFA
SUSPENSION; INTRATRACHEAL

CUROSURF

XX + CORNERSTONE THERAP 80MG/ML

PORFIMER SODIUM
INJECTABLE; INJECTION
PHOTOFRIN
XX
PINNACLE BIOLGS

75MG/VIAL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 340 (of 424)

POSACONAZOLE
SUSPENSION; ORAL

NOXAFIL

XX + SCHERING

40MG/ML

N022003 001

Sep 15, 2006

N018896 001

Jul 20, 1984

POTASSIUM ACETATE
INJECTABLE; INJECTION

POTASSIUM ACETATE IN PLASTIC CONTAINER

2MEQ/ML
XX + HOSPIRA

POTASSIUM CHLORIDE

AB
AB
AB
AB
AB
AB

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
XX

AB
AB
AB
AB
AB
AB
AB

CAPSULE, EXTENDED RELEASE; ORAL

MICRO-K
NESHER PHARMS
8MEQ
MICRO-K 10
NESHER PHARMS
10MEQ
POTASSIUM CHLORIDE
PADDOCK LLC
8MEQ
10MEQ
WATSON LABS FLORIDA
8MEQ
+
10MEQ
INJECTABLE; INJECTION
POTASSIUM CHLORIDE
APP PHARMS
2MEQ/ML
B BRAUN
2MEQ/ML
BAXTER HLTHCARE
2MEQ/ML
+ HOSPIRA
2MEQ/ML
INTL MEDICATION
2MEQ/ML
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
14.9MG/ML
+
746MG/100ML
HOSPIRA
14.9MG/ML
745MG/100ML
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
29.8MG/ML
+
1.49GM/100ML
+ HOSPIRA
29.8MG/ML
1.49GM/100ML
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
2.24GM/100ML
+ HOSPIRA
2.24GM/100ML
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
2.98GM/100ML
+ HOSPIRA
2.98GM/100ML
POTASSIUM CHLORIDE IN PLASTIC CONTAINER
APP PHARMS
2MEQ/ML
2MEQ/ML
POTASSIUM CHLORIDE
+ APP PHARMS
3MEQ/ML
TABLET, EXTENDED RELEASE;
KLOR-CON M10
UPSHER SMITH
KLOR-CON M20
UPSHER SMITH
POTASSIUM CHLORIDE
EURAND
NESHER PHARMS
SCHERING
+
WATSON LABS FLORIDA

N018238 001
N018238 002

May 14, 1984

A200185
A200185
A077419
A077419

001
002
001
002

May
May
Jun
Jun

18,
18,
02,
02,

2011
2011
2008
2008

A080225
A085870
A085499
A080205
A083163

001
001
001
001
001

N019904
N019904
N020161
N020161

001
005
005
001

Dec
Dec
Nov
Nov

26,
17,
30,
30,

1989
1990
1992
1992

N019904
N019904
N020161
N020161

002
006
006
002

Dec
Dec
Aug
Nov

26,
17,
11,
30,

1989
1990
1998
1992

N019904 003
N020161 003

Dec 26, 1989

Aug 11, 1998

N019904 004
N020161 004

Dec 26, 1989

Aug 11, 1998

A088901 001
A088908 001

Jan 25, 1985

Jan 25, 1985

A080225 003

ORAL
10MEQ

A074726 002

Aug 09, 2000

20MEQ

A074726 001

Nov 20, 1998

20MEQ
20MEQ
10MEQ
20MEQ
10MEQ

A076368
A076044
N019439
N019439
A075604

Aug
Apr
Jun
Jun
Apr

001
001
002
001
001

18,
05,
13,
13,
10,

2004
2002
1986
1986
2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 341 (of 424)

POTASSIUM CHLORIDE

AB
BC
BC
BC
BC
BC
BC
BC
XX

TABLET, EXTENDED RELEASE;

POTASSIUM CHLORIDE
WATSON LABS FLORIDA
K+10
FUTURE PAK
KAON CL-10
SAVAGE LABS
KLOR-CON
UPSHER-SMITH LABS
+
KLOTRIX
APOTHECON
K-TAB
ABBOTT
POTASSIUM CHLORIDE
ABBOTT
KLOR-CON M15
UPSHER SMITH

ORAL
20MEQ

A075604 002

Apr 10, 2002

10MEQ

A070999 001

Oct 22, 1987

10MEQ

N017046 002

8MEQ
10MEQ

N019123 001
N019123 002

10MEQ

N017850 001

10MEQ

N018279 001

8MEQ

N018279 002

Aug 01, 1988

15MEQ

A074726 003

Jun 06, 2003

Apr 17, 1986

Apr 17, 1986

POTASSIUM CHLORIDE; SODIUM CHLORIDE

AP
AP
AP
AP
AP
AP
AP
XX

INJECTABLE; INJECTION
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA
149MG/100ML;450MG/100ML
A078446
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
150MG/100ML;450MG/100ML
N017648
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
150MG/100ML;900MG/100ML
N019708
BAXTER HLTHCARE
150MG/100ML;900MG/100ML
N017648
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE
300MG/100ML;900MG/100ML
N017648
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA
149MG/100ML;900MG/100ML
N019686
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA
298MG/100ML;900MG/100ML
N019686
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
BAXTER HLTHCARE
224MG/100ML;900MG/100ML
N017648

001

Sep 10, 2008

005

Nov 26, 2002

004
001

Sep 29, 1989

002
001

Oct 17, 1988

002

Oct 17, 1988

003

POTASSIUM CITRATE
TABLET, EXTENDED RELEASE; ORAL
POTASSIUM CITRATE
COREPHARMA
AB
5MEQ
AB
10MEQ
UROCIT-K
MISSION PHARMA
AB
5MEQ
AB
10MEQ
UROCIT-K
15MEQ
XX + MISSION PHARMA

A077440 001
A077440 002

Jun 09, 2006

Jun 09, 2006

N019071 001
N019071 002

Aug 30, 1985

Aug 31, 1992

N019071 003

Dec 30, 2009

N018634 001

Dec 17, 1986

N022468 001
N022468 002

Sep 24, 2009

Sep 24, 2009

POVIDONE-IODINE
SOLUTION/DROPS; OPHTHALMIC

BETADINE

XX + ALCON PHARMS LTD

5%

PRALATREXATE
SOLUTION; INTRAVENOUS
FOLOTYN
ALLOS
XX
XX +

20MG/ML (20MG/ML)
40MG/2ML (20MG/ML)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 342 (of 424)

PRALIDOXIME CHLORIDE
INJECTABLE; INJECTION

PRALIDOXIME CHLORIDE

XX + MERIDIAN MEDCL TECHN

PROTOPAM CHLORIDE
XX + BAXTER HLTHCARE CORP

300MG/ML

N018986 001

1GM/VIAL

N014134 001

Apr 26, 1983

PRAMIPEXOLE DIHYDROCHLORIDE
TABLET; ORAL
MIRAPEX
BOEHRINGER INGELHEIM 0.125MG
AB
AB +
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
PRAMIPEXOLE DIHYDROCHLORIDE
ACTAVIS PHARMA
AB
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
ALEMBIC LTD
AB
0.125MG
AB
0.25MG
AB
0.5MG
AB
1MG
AB
1.5MG
BARR
AB
0.125MG
AB
0.25MG
AB
0.5MG
AB
1MG
AB
1.5MG
BRECKENRIDGE PHARM
AB
0.125MG
AB
0.25MG
AB
0.5MG
AB
1MG
AB
1.5MG
GLENMARK GENERICS
AB
0.125MG
AB
0.25MG
AB
0.5MG
AB
1MG
AB
1.5MG
MYLAN
AB
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
SANDOZ
AB
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG
AB
1.5MG
TEVA PHARMS
AB
0.125MG
AB
0.25MG
AB
0.5MG
AB
0.75MG
AB
1MG

N020667
N020667
N020667
N020667
N020667
N020667

001
002
006
007
003
005

Jul
Jul
Feb
Jul
Jul
Jul

01,
01,
12,
30,
01,
01,

1997
1997
1998
2007
1997
1997

A091254
A091254
A091254
A091254
A091254
A091254
A078894
A078894
A078894
A078894
A078894
A077724
A077724
A077724
A077724
A077724
A091450
A091450
A091450
A091450
A091450
A090781
A090781
A090781
A090781
A090781
A077854
A077854
A077854
A090764
A077854
A077854
A090190
A090190
A090190
A090190
A090190
A090190
A090241
A090241
A090241
A090241
A090241

001
002
003
004
005
006
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
001
004
005
001
002
003
006
004
005
001
002
003
004
005

Nov
Nov
Nov
Nov
Nov
Nov
Oct
Oct
Oct
Oct
Oct
Feb
Feb
Feb
Feb
Feb
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Apr
Oct
Oct
Jul
Jul
Jul
Oct
Jul
Jul
Oct
Oct
Oct
Oct
Oct

30,
30,
30,
30,
30,
30,
08,
08,
08,
08,
08,
19,
19,
19,
19,
19,
08,
08,
08,
08,
08,
08,
08,
08,
08,
08,
08,
08,
08,
09,
08,
08,
06,
06,
06,
08,
06,
06,
08,
08,
08,
08,
08,

2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2008
2008
2008
2008
2008
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 343 (of 424)

PRAMIPEXOLE DIHYDROCHLORIDE
TABLET; ORAL
PRAMIPEXOLE DIHYDROCHLORIDE
TEVA PHARMS
1.5MG
TORRENT PHARMS
0.125MG
0.25MG
0.5MG
0.75MG
1MG
1.5MG
WATSON LABS
0.125MG
0.25MG
0.5MG
1MG
1.5MG
ZYDUS PHARMS USA INC 0.125MG
0.25MG
0.5MG
1MG
1.5MG

A090241
A090865
A090865
A090865
A090865
A090865
A090865
A078551
A078551
A078551
A078551
A078551
A078920
A078920
A078920
A078920
A078920

006
001
002
003
004
005
006
001
002
003
004
005
001
002
003
004
005

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Jul
Jul
Jul
Jul
Jul

08,
08,
08,
08,
08,
08,
08,
08,
08,
08,
08,
08,
06,
06,
06,
06,
06,

2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010

TABLET, EXTENDED RELEASE; ORAL

MIRAPEX ER

XX + BOEHRINGER INGELHEIM 0.375MG

0.75MG
XX
1.5MG
XX
2.25MG
XX
3MG
XX
3.75MG
XX
4.5MG
XX

N022421
N022421
N022421
N022421
N022421
N022421
N022421

001
002
003
006
004
007
005

Feb
Feb
Feb
Jun
Feb
Jun
Feb

19,
19,
19,
17,
19,
17,
19,

2010
2010
2010
2011
2010
2011
2010

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

PRAMLINTIDE ACETATE
INJECTABLE; SUBCUTANEOUS
SYMLIN
XX
AMYLIN
XX
XX +

EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)

EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)
EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)

N021332 002
N021332 003
N021332 001

Sep 25, 2007

Sep 25, 2007
Mar 16, 2005

EQ 5MG BASE
EQ 10MG BASE

N022307 001
N022307 002

Jul 10, 2009

Jul 10, 2009

10MG
20MG
40MG
80MG

N019898
N019898
N019898
N019898

002
003
004
008

Oct
Oct
Mar
Dec

31,
31,
22,
18,

1991
1991
1993
2001

10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG

A076341
A076341
A076341
A076341
A076714
A076714
A076714
A076714
A077987

001
002
003
004
001
002
003
004
001

Oct
Oct
Oct
Dec
Oct
Oct
Oct
Dec
May

23,
23,
23,
28,
23,
23,
23,
28,
11,

2006
2006
2006
2007
2006
2006
2006
2007
2007

PRASUGREL HYDROCHLORIDE
TABLET; ORAL
EFFIENT
ELI LILLY AND CO
XX
XX +

PRAVASTATIN SODIUM
TABLET; ORAL
PRAVACHOL
BRISTOL MYERS SQUIBB
AB
AB
AB
AB +
PRAVASTATIN SODIUM
APOTEX
AB
AB
AB
AB
DR REDDYS LABS INC
AB
AB
AB
AB
GLENMARK GENERICS
AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 344 (of 424)

PRAVASTATIN SODIUM
TABLET; ORAL
PRAVASTATIN SODIUM
GLENMARK GENERICS
AB
AB
AB
LEK PHARMS DD
AB
AB
AB
AB
LUPIN PHARMS
AB
AB
AB
AB
MATRIX LABS LTD
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
PLIVA HRVATSKA DOO
AB
AB
AB
RANBAXY
AB
AB
AB
AB
TEVA
AB
AB
AB
TEVA PHARMS
AB
WATSON LABS
AB
AB
AB
AB
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB
AB
PRAVASTATIN SODIUM
PLIVA HRVATSKA DOO
XX

002
003
004
003
002
001
001
001
002
003
004
001
002
003
004
001
002
003
004
001
002
005
001
002
003
004
001
002
003
001
004
001
003
002
002
003
001
001
002
003
004

May
May
Dec
Oct
Oct
Oct
Feb
Jan
Jan
Jan
Jan
May
May
May
May
Oct
Oct
Oct
Dec
Nov
Nov
Nov
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Jan
Oct
Oct
Oct
Oct
Oct
Oct
Dec
Apr
Apr
Apr
Apr

11,
11,
28,
23,
23,
23,
11,
08,
08,
08,
08,
27,
27,
27,
27,
23,
23,
23,
28,
21,
21,
21,
23,
23,
23,
23,
24,
24,
24,
15,
23,
23,
23,
23,
23,
23,
28,
30,
30,
30,
30,

2007
2007
2007
2006
2006
2006
2008
2008
2008
2008
2008
2010
2010
2010
2010
2006
2006
2006
2007
2006
2006
2006
2007
2007
2007
2007
2006
2006
2006
2008
2006
2006
2006
2006
2006
2006
2007
2008
2008
2008
2008

20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG
10MG
10MG
20MG
20MG
40MG
40MG
80MG
10MG
20MG
40MG
80MG

A077987
A077987
A077987
A076397
A076397
A076397
A077491
A077917
A077917
A077917
A077917
A079187
A079187
A079187
A079187
A077013
A077013
A077013
A077013
A077730
A077730
A077730
A076445
A076445
A076445
A076445
A076056
A076056
A076056
A077793
A076939
A077904
A076939
A077904
A076939
A077904
A076939
A077751
A077751
A077751
A077751

30MG

A077730 003

Nov 21, 2006

600MG

N018714 001

Dec 29, 1982

EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE

N017442 002
N017442 003
N017442 001

EQ 1MG BASE

A071994 001

PRAZIQUANTEL
TABLET; ORAL

BILTRICIDE

XX + BAYER PHARMA AG

PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL
MINIPRESS
PFIZER
AB
AB +
AB
PRAZOSIN HYDROCHLORIDE
IVAX SUB TEVA PHARMS
AB

Sep 12, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 345 (of 424)

PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL
PRAZOSIN HYDROCHLORIDE
IVAX SUB TEVA PHARMS
AB
AB
MYLAN
AB
AB
AB

EQ
EQ
EQ
EQ
EQ

2MG
5MG
1MG
2MG
5MG

BASE
BASE
BASE
BASE
BASE

A071995
A071745
A072575
A072575
A072575

001
001
003
002
001

Sep
Sep
May
May
May

12,
12,
16,
16,
16,

1988
1988
1989
1989
1989

PREDNICARBATE
CREAM; TOPICAL
DERMATOP E EMOLLIENT
AB + SANOFI AVENTIS US
PREDNICARBATE
ALTANA
AB
OINTMENT; TOPICAL
DERMATOP
AB + SANOFI AVENTIS US
PREDNICARBATE
ALTANA
AB

0.1%

N020279 001

Oct 29, 1993

0.1%

A077287 001

Sep 19, 2006

0.1%

N019568 001

Sep 23, 1991

0.1%

A077236 001

Mar 09, 2007

May
Aug
Aug
Feb
Oct
Apr
Mar
Sep
Sep

PREDNISOLONE
SYRUP; ORAL
PREDNISOLONE
ALPHARMA
AA
APOTEX INC
AA
AA
HI TECH PHARMA
AA
AA + NESHER PHARMS
AA +
PHARM ASSOC
AA
VINTAGE
AA
WOCKHARDT
AA
PRELONE
TEVA
AA

15MG/5ML
5MG/5ML
15MG/5ML
15MG/5ML
5MG/5ML
15MG/5ML
15MG/5ML
15MG/5ML
15MG/5ML

A040323
A040570
A040571
A040401
A040423
A040364
A040399
A040775
A040313

15MG/5ML

A089081 001

TABLET; ORAL

PREDNISOLONE

XX + WATSON LABS

5MG

A080354 001

EQ 15MG BASE/5ML

N022067 002

001
001
001
001
001
001
001
001
001

13,
25,
25,
27,
22,
10,
05,
21,
10,

1999
2005
2005
2003
2001
2002
2003
2007
2003

Feb 04, 1986

PREDNISOLONE ACETATE
SUSPENSION; ORAL

FLO-PRED

XX + TARO

SUSPENSION/DROPS; OPHTHALMIC
OMNIPRED
ALCON
AB
1%
PRED FORTE
AB + ALLERGAN
1%
PRED MILD
0.12%
XX + ALLERGAN

Jan 17, 2008

N017469 001
N017011 001
N017100 001

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

OINTMENT; OPHTHALMIC

BLEPHAMIDE S.O.P.

XX + ALLERGAN

0.2%;10%

A087748 001

SUSPENSION; OPHTHALMIC

BLEPHAMIDE

XX + ALLERGAN

0.2%;10%

N012813 002

Dec 03, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 346 (of 424)

PREDNISOLONE SODIUM PHOSPHATE

AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA

SOLUTION; ORAL
ORAPRED
+ SHIONOGI INC
EQ 15MG BASE/5ML
PEDIAPRED
+ UCB INC
EQ 5MG BASE/5ML
PREDNISOLONE SODIUM PHOSPHATE
AMNEAL PHARMS
EQ 15MG BASE/5ML
HI TECH PHARMA
EQ 5MG BASE/5ML
NESHER PHARMS
EQ 5MG BASE/5ML
EQ 15MG BASE/5ML
PADDOCK LLC
EQ 5MG BASE/5ML
PHARM ASSOC
EQ 5MG BASE/5ML
EQ 15MG BASE/5ML
VINTAGE
EQ 15MG BASE/5ML
WE PHARMS
EQ 15MG BASE/5ML
WOCKHARDT
EQ 5MG BASE/5ML
EQ 15MG BASE/5ML
PREDNISOLONE SODIUM PHOSPHATE
+ PHARM ASSOC
EQ 10MG BASE/5ML
+
EQ 20MG BASE/5ML
+
EQ 25MG BASE/5ML

A075117 001

Dec 14, 2000

N019157 001

May 28, 1986

A078345
A075183
A076982
A076988
A075988
A076123
A076913
A079010
A075250
A075099
A076895

Mar
Mar
May
May
May
Dec
Apr
May
Jul
Jun
Oct

001
001
001
001
001
001
001
001
001
001
001

10,
26,
24,
24,
25,
23,
25,
26,
12,
28,
04,

2009
2003
2005
2005
2004
2002
2005
2009
2002
2002
2004

A078465 001
A078988 001
A091396 001

Mar 07, 2008

Jun 09, 2008
Sep 13, 2010

SOLUTION/DROPS; OPHTHALMIC

PREDNISOLONE SODIUM PHOSPHATE

XX + BAUSCH AND LOMB

EQ 0.9% PHOSPHATE

A040070 001

Jul 29, 1994

TABLET, ORALLY DISINTEGRATING; ORAL

ORAPRED ODT
XX
SHIONOGI INC
EQ 10MG BASE
XX
EQ 15MG BASE
XX +
EQ 30MG BASE

N021959 001
N021959 002
N021959 003

Jun 01, 2006

Jun 01, 2006
Jun 01, 2006

A073630 001
A074449 001

May 27, 1993

Dec 29, 1995

N018988 001

Aug 26, 1988

5MG/5ML

A088703 001

Nov 08, 1984

5MG/ML

A088810 001

Feb 20, 1985

5MG
1MG
5MG
10MG
20MG
5MG
10MG
20MG
1MG
2.5MG
5MG
10MG

A080209
A040611
A040362
A040362
A040362
A089245
A089246
A089247
A087800
A087801
A080352
A084122

XX
XX
XX

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

SOLUTION/DROPS; OPHTHALMIC
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE
ALCON PHARMS LTD
AT
EQ 0.23% PHOSPHATE;10%
BAUSCH AND LOMB
AT
EQ 0.23% PHOSPHATE;10%
VASOCIDIN
AT + NOVARTIS
EQ 0.23% PHOSPHATE;10%

PREDNISONE
SOLUTION; ORAL

PREDNISONE

XX + ROXANE
PREDNISONE INTENSOL
XX + ROXANE
TABLET; ORAL
PREDNISONE
CONTRACT PHARMACAL
AB
JUBILANT CADISTA
AB
AB
AB
AB
MUTUAL PHARM
AB
AB
AB
AB + ROXANE
AB +
AB +
AB +

001
001
002
001
003
001
001
001
001
001
001
001

Jun
Aug
Aug
Jun
Dec
Dec
Dec
Apr
Apr

06,
29,
29,
29,
04,
04,
04,
22,
22,

2005
2001
2001
2005
1985
1985
1985
1982
1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 347 (of 424)

PREDNISONE
TABLET; ORAL
PREDNISONE
AB + ROXANE
AB +
VINTAGE PHARMS
AB
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
WEST WARD
AB
AB
AB
AB
WEST WARD PHARM CORP
AB

20MG
50MG
1MG
2.5MG
5MG
10MG
20MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG
1MG

A087342
A084283
A040584
A040581
A040256
A040256
A040392
A080356
A085162
A085161
A040538
A080292
A088832
A083677
A040890

001
001
001
001
001
002
001
001
001
001
001
001
001
001
001

Nov 01, 2010

CAPSULE; ORAL
LYRICA
CPPI CV
XX
XX
XX
XX
XX
XX
XX
XX +

25MG
50MG
75MG
100MG
150MG
200MG
225MG
300MG

N021446
N021446
N021446
N021446
N021446
N021446
N021446
N021446

001
002
003
004
005
006
007
008

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

SOLUTION; ORAL

LYRICA

XX + CPPI CV

20MG/ML

N022488 001

Dec
Dec
Jul
Jul
Feb

21,
21,
12,
12,
12,

2004
2004
2002
2002
2003

Jan 08, 2004

Dec 04, 1985

PREGABALIN

30,
30,
30,
30,
30,
30,
30,
30,

2004
2004
2004
2004
2004
2004
2004
2004

Jan 04, 2010

PRILOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
CITANEST PLAIN DENTAL
AP + DENTSPLY PHARM
4%
PRILOCAINE HYDROCHLORIDE
SEPTODONT INC
AP
4%

N021382 001
A079235 001

Sep 29, 2010

PRIMAQUINE PHOSPHATE
TABLET; ORAL

PRIMAQUINE

XX + SANOFI AVENTIS US

EQ 15MG BASE

N008316 001

50MG
250MG

N009170 003
N009170 002

50MG
250MG
50MG
250MG
50MG
250MG
50MG

A040866
A040866
A040862
A040862
A040717
A040717
A084903

PRIMIDONE
TABLET; ORAL
MYSOLINE
AB + VALEANT
AB
PRIMIDONE
AMNEAL PHARM
AB
AB
DR REDDYS LABS LTD
AB
AB
IMPAX LABS
AB
AB
LANNETT
AB

001
002
001
002
001
002
002

Apr
Apr
Oct
Oct
Feb
Feb
May

23,
23,
03,
03,
12,
12,
24,

2008
2008
2008
2008
2008
2008
2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 348 (of 424)

PRIMIDONE
TABLET; ORAL
PRIMIDONE
LANNETT
AB
MUTUAL PHARM
AB
AB
VINTAGE PHARMS
AB
AB
WATSON LABS
AB
WEST WARD
AB
AB

250MG
50MG
250MG
50MG
250MG
250MG
50MG
250MG

A084903
A040626
A040626
A040586
A040586
A083551
A040667
A040667

001
001
002
001
002
001
001
002

500MG

A080966 001

500MG
500MG
500MG

A083740 001
A084211 002
A084442 004

May 09, 1984

A089069
A089070
A088636
A088637

Feb
Feb
Jul
Jul

Sep
Sep
Feb
Feb

29,
29,
24,
24,

2005
2005
2005
2005

Jul 27, 2006

Jul 27, 2006

PROBENECID

AB
AB
AB
AB

TABLET; ORAL
PROBALAN
LANNETT
PROBENECID
IVAX SUB TEVA PHARMS
+ MYLAN
WATSON LABS

Mar 29, 1983

PROCAINAMIDE HYDROCHLORIDE

AP
AP
AP
AP

INJECTABLE; INJECTION
PROCAINAMIDE HYDROCHLORIDE
+ HOSPIRA
100MG/ML
+
500MG/ML
INTL MEDICATION
100MG/ML
500MG/ML

001
001
001
001

12,
12,
31,
31,

1986
1986
1984
1984

PROCARBAZINE HYDROCHLORIDE
CAPSULE; ORAL

MATULANE

XX + SIGMA TAU

EQ 50MG BASE

N016785 001

25MG

A040246 001

Jun 28, 2000

25MG

A040058 001

Nov 24, 1993

A089903 001
A040540 001

Aug 29, 1989

May 28, 2004

5MG BASE
10MG BASE
5MG BASE
10MG BASE
5MG BASE
10MG BASE

A040185
A040185
A040101
A040101
A040120
A040120

Oct
Oct
Jul
Jul
Jul
Jul

5MG BASE
10MG BASE

A040268 001
A040268 002

PROCHLORPERAZINE
SUPPOSITORY; RECTAL
COMPRO
PADDOCK LLC
AB
PROCHLORPERAZINE
AB + G AND W LABS

PROCHLORPERAZINE EDISYLATE
INJECTABLE; INJECTION
PROCHLORPERAZINE EDISYLATE
AP + BAXTER HLTHCARE
EQ 5MG BASE/ML
BEDFORD
AP
EQ 5MG BASE/ML

PROCHLORPERAZINE MALEATE
TABLET; ORAL
PROCHLORPERAZINE MALEATE
MYLAN
AB
EQ
AB
EQ
SANDOZ
AB
EQ
AB +
EQ
TEVA PHARMS
AB
EQ
AB
EQ
PROCOMP
JUBILANT CADISTA
AB
EQ
AB
EQ

002
001
001
002
001
002

28,
28,
19,
19,
11,
11,

1996
1996
1996
1996
1996
1996

Feb 27, 1998

Feb 27, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 349 (of 424)

PROGESTERONE
CAPSULE; ORAL
PROMETRIUM
ABBOTT LABS
XX
XX +

100MG
200MG

N019781 001
N019781 002

May 14, 1998

Oct 15, 1999

GEL; VAGINAL
CRINONE
WATSON LABS
XX
XX +

4%
8%

N020701 001
N020701 002

Jul 31, 1997

Jul 31, 1997

50MG/ML
50MG/ML
50MG/ML
50MG/ML

A075906
A091033
A090845
N017362

001
001
001
002

Apr 25, 2001

Oct 28, 2010
Jun 22, 2009

100MG

N022057 001

Jun 21, 2007

A083312
A083312
A040372
A040515
A040454
A040454
A040785
A040785
A040737
A040737

001
002
001
001
001
002
001
002
001
002

Jun
Mar
Aug
Aug
Sep
Sep
Apr
Apr

08,
19,
22,
22,
26,
26,
24,
24,

2000
2003
2002
2002
2008
2008
2008
2008

SUPPOSITORY; RECTAL
PROMETHAZINE HYDROCHLORIDE
G AND W LABS
12.5MG
+
25MG
PADDOCK LLC
12.5MG
25MG
PERRIGO NEW YORK
12.5MG
25MG
TARO
12.5MG
25MG
PROMETHEGAN
+ G AND W LABS
50MG

A040428
A040428
A040479
A040479
A040500
A040500
A040603
A040603

002
001
001
002
001
002
001
002

Mar
Feb
Jun
Jun
Jun
Jun
Oct
Oct

31,
05,
24,
24,
30,
30,
26,
26,

2003
2002
2003
2003
2003
2003
2006
2006

A087165 001

Aug 14, 1987

A040882
A040026
A040891
A040718
A040643

Dec
Sep
Mar
Apr
Apr

AA

SYRUP; ORAL
PROMETHAZINE HYDROCHLORIDE
AMNEAL PHARMS
6.25MG/5ML
HI TECH PHARMA
6.25MG/5ML
SUN PHARM INDS INC
6.25MG/5ML
TARO
6.25MG/5ML
VINTAGE
6.25MG/5ML
PROMETHAZINE PLAIN
+ WOCKHARDT
6.25MG/5ML

A087953 001

Nov 15, 1982

AB
AB
AB
AB

TABLET; ORAL
PROMETHAZINE HYDROCHLORIDE
AMNEAL PHARMS NY
12.5MG
25MG
50MG
EMCURE PHARMS USA
12.5MG

A091179
A091179
A091179
A040673

Dec
Dec
Dec
Mar

AO
AO
AO
AO

INJECTABLE; INJECTION
PROGESTERONE
APP PHARMS
HIKMA FARMACEUTICA
LUITPOLD
+ WATSON LABS (UTAH)

INSERT; VAGINAL

ENDOMETRIN

XX + FERRING

PROMETHAZINE HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

AB
AB
AB
AB
AB
AB
AB
AB
XX

AA
AA
AA
AA
AA

INJECTABLE; INJECTION
PROMETHAZINE HYDROCHLORIDE
BAXTER HLTHCARE
25MG/ML
50MG/ML
HOSPIRA
25MG/ML
LUITPOLD
25MG/ML
+ TEVA PARENTERAL
25MG/ML
+
50MG/ML
WOCKHARDT
25MG/ML
50MG/ML
X-GEN PHARMS
25MG/ML
50MG/ML

001
001
001
001
001

001
002
003
001

30,
25,
13,
04,
26,

13,
13,
13,
05,

2009
1998
2009
2007
2006

2010
2010
2010
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 350 (of 424)

PROMETHAZINE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
PROMETHAZINE HYDROCHLORIDE
EMCURE PHARMS USA
25MG
50MG
IMPAX LABS
12.5MG
25MG
50MG
KVK TECH
12.5MG
25MG
50MG
MYLAN
12.5MG
25MG
50MG
SANDOZ
25MG
+
50MG
SUN PHARM INDS INC
12.5MG
25MG
50MG
VINTAGE PHARMS
12.5MG
25MG
50MG
WATSON LABS
25MG
50MG
ZYDUS PHARMS USA
12.5MG
25MG
50MG

A040673
A040673
A040724
A040724
A040791
A040712
A040712
A040713
A091054
A091054
A091054
A084234
A084176
A040863
A040863
A040863
A040622
A040622
A040622
A083426
A083711
A040596
A040596
A040596

Mar
Mar
Feb
Feb
May
May
Jul
Jul
Aug
Aug
Aug

05,
05,
12,
12,
20,
04,
31,
31,
30,
30,
30,

2008
2008
2008
2008
2008
2007
2006
2006
2011
2011
2011

Dec
Dec
Dec
Jul
Jul
Jul

30,
30,
30,
18,
18,
18,

2008
2008
2008
2006
2006
2006

002
003
001
002
001
002
001
001
001
002
003
001
001
001
002
003
001
002
003
001
001
001
002
003

Nov 18, 2005

Nov 18, 2005
Nov 18, 2005

A078540 001
A078540 002
A078540 003

Oct 18, 2010

Oct 18, 2010
Oct 18, 2010

N021416 001
N021416 002
N021416 003

Sep 04, 2003

Sep 04, 2003
Sep 04, 2003

A075998
A075998
A075998
A076193
A076193
A076193
A076550
A076550
A076550
A075938
A075938
A075938
A075203
A075203

Nov
Nov
Nov
Feb
Feb
Feb
Apr
Apr
Apr
Oct
Oct
Oct
Oct
Oct

PROPAFENONE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

CAPSULE, EXTENDED RELEASE; ORAL

PROPAFENONE HYDROCHLORIDE
PAR PHARM
225MG
325MG
425MG
RYTHMOL SR
GLAXOSMITHKLINE LLC
225MG
325MG
+
425MG
TABLET; ORAL
PROPAFENONE HYDROCHLORIDE
MUTUAL PHARM
150MG
225MG
300MG
NESHER PHARMS
150MG
225MG
300MG
PLIVA
150MG
225MG
300MG
VINTAGE PHARMS
150MG
225MG
300MG
WATSON LABS
150MG
225MG
RYTHMOL
GLAXOSMITHKLINE LLC
150MG
225MG
+
300MG

001
002
003
001
002
003
001
002
003
001
002
003
001
002

N019151 001
N019151 003
N019151 002

29,
29,
29,
07,
07,
07,
23,
23,
23,
17,
17,
17,
24,
24,

2001
2001
2001
2002
2002
2002
2004
2004
2004
2002
2002
2002
2000
2000

Nov 27, 1989

Nov 20, 1992
Nov 27, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 351 (of 424)

PROPANTHELINE BROMIDE
TABLET; ORAL

PROPANTHELINE BROMIDE

XX + ROXANE

15MG

A080927 002

PROPARACAINE HYDROCHLORIDE

AT
AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
ALCAINE
ALCON
0.5%
OPHTHAINE
+ APOTHECON
0.5%
OPHTHETIC
+ ALLERGAN
0.5%
PROPARACAINE HYDROCHLORIDE
BAUSCH AND LOMB
0.5%
TAYLOR PHARMA
0.5%

A080027 001
N008883 001
N012583 001
A040074 001
A040277 001

Sep 29, 1995

Mar 16, 2000

10MG/ML

N019627 002

Jun 11, 1996

10MG/ML
10MG/ML

A077908 001
A075102 001

Mar 17, 2006

Jan 04, 1999

N018553
N018553
N018553
N018553

004
002
003
001

Mar
Apr
Apr
Apr

18,
19,
19,
19,

1987
1983
1983
1983

A078494
A078494
A078494
A078494
A078703
A078703
A078703
A078703
A078022
A078022
A078022
A078022
A078065
A078065
A078065
A078065
A078311
A078311
A078311
A078311
A090321
A090321
A090321
A090321

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Aug
Aug
Aug
Aug
Jul
Jul
Jul
Jul
Feb
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

10,
10,
10,
10,
15,
15,
15,
15,
15,
15,
15,
15,
26,
26,
26,
26,
06,
06,
06,
06,
25,
25,
25,
25,

2007
2007
2007
2007
2011
2011
2011
2011
2007
2007
2007
2007
2007
2007
2007
2007
2009
2009
2009
2009
2011
2011
2011
2011

PROPOFOL
INJECTABLE; INJECTION
DIPRIVAN
AB + APP PHARMS
PROPOFOL
HOSPIRA
AB
TEVA PARENTERAL
AB

PROPRANOLOL HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
BX
BX

CAPSULE, EXTENDED RELEASE; ORAL

INDERAL LA
AKRIMAX PHARMS
60MG
80MG
120MG
+
160MG
PROPRANOLOL HYDROCHLORIDE
ACTAVIS ELIZABETH
60MG
80MG
120MG
160MG
GLAXOSMITHKLINE
60MG
80MG
120MG
160MG
MYLAN
60MG
80MG
120MG
160MG
PAR PHARM
60MG
80MG
120MG
160MG
UPSHER SMITH
60MG
80MG
120MG
160MG
ZYDUS PHARMS USA INC 60MG
80MG
120MG
160MG
INNOPRAN XL
GLAXOSMITHKLINE LLC
80MG
120MG

N021438 001
N021438 002

Mar 12, 2003

Mar 12, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 352 (of 424)

PROPRANOLOL HYDROCHLORIDE

AP
AP
AP
AP
AP

INJECTABLE; INJECTION
PROPRANOLOL HYDROCHLORIDE
APP PHARMS
1MG/ML
+ BAXTER HLTHCARE CORP 1MG/ML
BEDFORD
1MG/ML
HIKMA FARMACEUTICA
1MG/ML
SANDOZ
1MG/ML

SOLUTION; ORAL

PROPRANOLOL HYDROCHLORIDE

20MG/5ML
XX + ROXANE
40MG/5ML
XX +
TABLET; ORAL
INDERAL
AKRIMAX PHARMS
AB
40MG
AB
60MG
AB +
80MG
PROPRANOLOL HYDROCHLORIDE
IPCA LABS LTD
AB
10MG
AB
20MG
AB
40MG
AB
60MG
AB
80MG
MYLAN
AB
10MG
AB
20MG
AB
40MG
AB
60MG
AB
80MG
NORTHSTAR HLTHCARE
AB
10MG
AB
20MG
AB
40MG
AB
60MG
AB
80MG
PLIVA
AB
10MG
AB
20MG
AB
40MG
AB
60MG
AB +
80MG
VINTAGE PHARMS
AB
10MG
AB
20MG
AB
40MG
AB
60MG
AB
80MG
WATSON LABS
AB
10MG
AB
20MG
AB
40MG
AB
80MG

001
001
001
001
001

Aug 31, 2001

A070979 001
A070690 001

May 15, 1987

May 15, 1987

N016418 002
N016418 009
N016418 004

Oct 18, 1982

A078955
A078955
A078955
A078955
A078955
A070213
A070213
A070213
A070213
A070213
A078213
A078213
A078213
A078213
A078213
A071972
A071973
A071974
A071975
A071976
A070217
A070218
A070219
A070220
A070221
A070175
A070176
A070177
A070178

Jun
Jun
Jun
Jun
Jun
Nov
Nov
Nov
Apr
Nov
Jan
Jan
Jan
Jan
Jan
Apr
Apr
Apr
Apr
Apr
Aug
Aug
Aug
Sep
Apr
May
May
May
May

A075826
N016419
A075792
A077760
A076400

001
002
003
004
005
002
003
001
005
004
001
002
003
004
005
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Aug 29, 2000

Jan 31, 2008
Feb 26, 2003

02,
02,
02,
02,
02,
19,
19,
19,
08,
19,
10,
10,
10,
10,
10,
06,
06,
06,
06,
06,
01,
01,
01,
24,
14,
13,
13,
13,
13,

2008
2008
2008
2008
2008
1985
1985
1985
2011
1985
2008
2008
2008
2008
2008
1988
1988
1988
1988
1988
1986
1986
1986
1986
1986
1986
1986
1986
1986

PROPYLTHIOURACIL
TABLET; ORAL
PROPYLTHIOURACIL
BD
ACTAVIS ELIZABETH
BD + DAVA PHARMS INC
BD
WEST WARD

50MG
50MG
50MG

A080172 001
N006188 001
A080154 001

10MG/ML

A089454 001

PROTAMINE SULFATE
INJECTABLE; INJECTION

PROTAMINE SULFATE

XX + APP PHARMS

Apr 07, 1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 353 (of 424)

PROTRIPTYLINE HYDROCHLORIDE
TABLET; ORAL
PROTRIPTYLINE HYDROCHLORIDE
ROXANE
AB
5MG
AB
10MG
SIGMAPHARM LABS LLC
AB
5MG
AB
10MG
VIVACTIL
ODYSSEY PHARMS
AB
5MG
AB +
10MG

A078913
A078913
A090462
A090462

001
002
001
002

Sep
Sep
May
May

16,
16,
03,
03,

2008
2008
2010
2010

A073644 001
A073645 001

Aug 24, 1995

Aug 24, 1995

500MG
500MG

A080157 001
A081319 001

Jun 30, 1992

PYRAZINAMIDE
TABLET; ORAL
PYRAZINAMIDE
AB + DAVA PHARMS INC
MIKART
AB

PYRIDOSTIGMINE BROMIDE
INJECTABLE; INJECTION
MESTINON
AP + VALEANT PHARM INTL
REGONOL
SANDOZ
AP

5MG/ML

N009830 001

5MG/ML

N017398 001

SYRUP; ORAL

MESTINON

XX + VALEANT PHARM INTL

60MG/5ML

N015193 001

60MG

N009829 002

60MG
60MG

A040457 001
A040502 001

TABLET; ORAL
MESTINON
AB + VALEANT PHARM INTL
PYRIDOSTIGMINE BROMIDE
COREPHARMA
AB
IMPAX LABS
AB

TABLET, EXTENDED RELEASE; ORAL

MESTINON

XX + VALEANT PHARM INTL

180MG

Dec 26, 2002

Apr 24, 2003

N011665 001

PYRIDOXINE HYDROCHLORIDE
INJECTABLE; INJECTION

PYRIDOXINE HYDROCHLORIDE

100MG/ML
XX + APP PHARMS

A080618 001

PYRIMETHAMINE
TABLET; ORAL

DARAPRIM

XX + COREPHARMA

25MG

N008578 001

15MG

N018708 001

Dec 27, 1985

EQ
EQ
EQ
EQ
EQ

N020639
N020639
N020639
N020639
N020639

Sep
Oct
Sep
Sep
Jul

QUAZEPAM
TABLET; ORAL

DORAL

XX + QUESTCOR PHARMS

QUETIAPINE FUMARATE
TABLET; ORAL

SEROQUEL

XX + ASTRAZENECA
XX
XX
XX
XX +

25MG BASE
50MG BASE
100MG BASE
200MG BASE
300MG BASE

001
007
002
003
005

26,
04,
26,
26,
26,

1997
2005
1997
1997
2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 354 (of 424)

QUETIAPINE FUMARATE
TABLET; ORAL
SEROQUEL
ASTRAZENECA
XX

EQ 400MG BASE

TABLET, EXTENDED RELEASE; ORAL

SEROQUEL XR
ASTRAZENECA
EQ 50MG BASE
XX
EQ 150MG BASE
XX
EQ 200MG BASE
XX +
EQ 300MG BASE
XX
EQ 400MG BASE
XX

N020639 006

Oct 04, 2005

N022047
N022047
N022047
N022047
N022047

001
005
002
003
004

May
Aug
May
May
May

17,
11,
17,
17,
17,

2007
2008
2007
2007
2007

QUINAPRIL HYDROCHLORIDE
TABLET; ORAL
ACCUPRIL
PFIZER PHARMS
AB
AB
AB
AB +
QUINAPRIL HYDROCHLORIDE
APOTEX
AB
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
AB
LUPIN
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
AB
AB
RANBAXY
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
SUN PHARM INDS LTD
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
WATSON LABS FLORIDA
AB
AB
AB
AB

EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
20MG BASE
40MG BASE

N019885
N019885
N019885
N019885

001
002
003
004

Nov
Nov
Nov
Nov

19,
19,
19,
19,

1991
1991
1991
1991

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
5MG BASE
10MG BASE
10MG BASE
20MG BASE
20MG BASE
40MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE
5MG BASE
10MG BASE
20MG BASE
40MG BASE

A076240
A076240
A076240
A076240
A078457
A078457
A078457
A078457
A077690
A077690
A077690
A077690
A076036
A076694
A076036
A076694
A076036
A076694
A076036
A076694
A076607
A076607
A076607
A076607
A076803
A076803
A076803
A076803
A090800
A090800
A090800
A090800
A075504
A075504
A075504
A075504
A076049
A076049
A076049
A076049

001
002
003
004
001
002
003
004
001
002
003
004
001
001
002
002
003
003
004
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Jan
Jan
Jan
Jan
Aug
Aug
Aug
Aug
Jun
Jun
Jun
Jun
Jan
Dec
Jan
Dec
Jan
Dec
Jan
Dec
Dec
Dec
Dec
Dec
Mar
Mar
Mar
Mar
Jun
Jun
Jun
Jun
Aug
Aug
Aug
Aug
Jan
Jan
Jan
Jan

26,
26,
26,
26,
24,
24,
24,
24,
20,
20,
20,
20,
28,
23,
28,
23,
28,
23,
28,
23,
15,
15,
15,
15,
02,
02,
02,
02,
18,
18,
18,
18,
24,
24,
24,
24,
14,
14,
14,
14,

2006
2006
2006
2006
2007
2007
2007
2007
2006
2006
2006
2006
2005
2004
2005
2004
2005
2004
2005
2004
2004
2004
2004
2004
2005
2005
2005
2005
2009
2009
2009
2009
2007
2007
2007
2007
2005
2005
2005
2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 355 (of 424)

QUINIDINE GLUCONATE
INJECTABLE; INJECTION

QUINIDINE GLUCONATE

XX + LILLY

80MG/ML

TABLET, EXTENDED RELEASE; ORAL

QUINIDINE GLUCONATE
BX + MUTUAL PHARM
324MG
BX
WATSON LABS
324MG

N007529 002

Feb 10, 1989

A089338 001
A087810 001

Feb 11, 1987

Sep 29, 1982

A081030
A081031
A088072
A088072
A083288
A085583

Apr 14, 1989

Apr 14, 1989

QUINIDINE SULFATE
TABLET; ORAL
QUINIDINE SULFATE
MUTUAL PHARM
AB
AB
SANDOZ
AB
AB
AB + WATSON LABS
AB +

200MG
300MG
200MG
300MG
200MG
300MG

TABLET, EXTENDED RELEASE; ORAL

QUINIDINE SULFATE

300MG
XX + TEVA PHARMS

001
001
002
001
001
001

Sep 26, 1983

A040045 001

Jun 30, 1994

N021799 001

Aug 12, 2005

N020973 002

Aug 19, 1999

60MG

N020815 001

Dec 09, 1997

TABLET; ORAL

ISENTRESS

XX + MERCK SHARP DOHME

EQ 400MG BASE

N022145 001

Oct 12, 2007

TABLET, CHEWABLE; ORAL

ISENTRESS
MERCK SHARP DOHME
XX
XX +

EQ 25MG BASE
EQ 100MG BASE

N203045 001
N203045 002

Dec 21, 2011

Dec 21, 2011

8MG

N021782 001

Jul 22, 2005

1.25MG
2.5MG
5MG
10MG

N019901
N019901
N019901
N019901

Jan
Jan
Jan
Jan

QUININE SULFATE
CAPSULE; ORAL

QUALAQUIN

XX + AR HOLDING CO INC

324MG

RABEPRAZOLE SODIUM
TABLET, DELAYED RELEASE; ORAL

ACIPHEX

20MG
XX + EISAI INC

RALOXIFENE HYDROCHLORIDE
TABLET; ORAL

EVISTA

XX + LILLY

RALTEGRAVIR POTASSIUM

RAMELTEON
TABLET; ORAL

ROZEREM

XX + TAKEDA GLOBAL

RAMIPRIL
CAPSULE; ORAL
ALTACE
KING PHARMS
AB
AB
AB
AB +

001
002
003
004

28,
28,
28,
28,

1991
1991
1991
1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 356 (of 424)

RAMIPRIL
CAPSULE; ORAL
RAMIPRIL
APOTEX
AB
AB
AB
AB
AUROBINDO PHARMA LTD
AB
AB
AB
AB
CIPLA
AB
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
AB
LUPIN
AB
AB
AB
AB
RANBAXY
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
AB
TABLET; ORAL
ALTACE
KING PHARMS
AB
AB
AB
AB +
RAMIPRIL
MATRIX LABS LTD
AB
AB
AB
AB

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
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

A079116
A079116
A079116
A079116
A091604
A091604
A091604
A091604
A077004
A077004
A077004
A077004
A078191
A078191
A078191
A078191
A078745
A078745
A078745
A078745
A077626
A077626
A077626
A077626
A078849
A078849
A077900
A077900
A077900
A077900
A077514
A077514
A077514
A077514
A077470
A077470
A077470
A077470
A076549
A076549
A076549
A076549
A078832
A078832
A078832
A078832

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Aug
Aug
Aug
Aug
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Mar
Mar
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep

20,
20,
20,
20,
08,
08,
08,
08,
07,
07,
07,
07,
18,
18,
18,
18,
18,
18,
18,
18,
09,
09,
09,
09,
06,
06,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
24,
24,
24,
24,
02,
02,
02,
02,

2008
2008
2008
2008
2011
2011
2011
2011
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2009
2009
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2005
2005
2005
2005
2008
2008
2008
2008

1.25MG
2.5MG
5MG
10MG

N022021
N022021
N022021
N022021

001
002
003
004

Feb
Feb
Feb
Feb

27,
27,
27,
27,

2007
2007
2007
2007

1.25MG
2.5MG
5MG
10MG

A090650
A090650
A090650
A090650

001
002
003
004

Jun
Jun
Jun
Jun

30,
30,
30,
30,

2011
2011
2011
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 357 (of 424)

RAMIPRIL
TABLET; ORAL
RAMIPRIL
ZYDUS PHARMS USA INC
AB
AB
AB
AB

1.25MG
2.5MG
5MG
10MG

A090697
A090697
A090697
A090697

001
002
003
004

Sep
Sep
Sep
Sep

24,
24,
24,
24,

2009
2009
2009
2009

A075742
A075742
A074655
A074655

001
002
001
002

Nov
Nov
Oct
Oct

29,
29,
22,
22,

2000
2000
1997
1997

RANITIDINE HYDROCHLORIDE

AB
AB
AB
AB

AP
AP
AP
XX

CAPSULE; ORAL
RANITIDINE HYDROCHLORIDE
DR REDDYS LABS LTD
EQ
EQ
SANDOZ
EQ
+
EQ

BASE
BASE
BASE
BASE

INJECTABLE; INJECTION
RANITIDINE HYDROCHLORIDE
BEDFORD
EQ 25MG BASE/ML
BEN VENUE
EQ 25MG BASE/ML
ZANTAC
+ GLAXOSMITHKLINE
EQ 25MG BASE/ML
ZANTAC IN PLASTIC CONTAINER
+ GLAXOSMITHKLINE
EQ 1MG BASE/ML

AA

SYRUP; ORAL
RANITIDINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC EQ
AMNEAL PHARMS
EQ
APOTEX
EQ
AUROBINDO PHARM
EQ
CYPRESS PHARM
EQ
DR REDDYS LABS LTD
EQ
HI TECH PHARMA
EQ
PHARM ASSOC
EQ
RANBAXY
EQ
SILARX
EQ
SUN PHARM INDS INC
EQ
TARO
EQ
TOLMAR
EQ
VINTAGE PHARMS
EQ
WOCKHARDT
EQ
EQ
ZANTAC
+ GLAXOSMITHKLINE
EQ

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
RANITIDINE HYDROCHLORIDE
AMNEAL PHARMS NY
EQ
EQ
APOTEX
EQ
EQ
DR REDDYS LABS INC
EQ
EQ
GLENMARK GENERICS
EQ
EQ
IVAX SUB TEVA PHARMS EQ
EQ
MYLAN
EQ
EQ
PAR PHARM
EQ
EQ
SANDOZ
EQ

AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA

150MG
300MG
150MG
300MG

15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG
15MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

A077458 001
A074777 001

Feb 16, 2006

Mar 02, 2005

N019090 001

Oct 19, 1984

N019593 002

Sep 27, 1991

A076124
A078312
A077602
A090623
A078684
A090102
A091078
A077405
A078448
A091288
A091091
A077476
A090054
A078890
A079211
A079212

Feb
Sep
Sep
Jul
Aug
May
Mar
Sep
Dec
Dec
Sep
Jun
Nov
Jul
May
Feb

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

21,
02,
17,
28,
27,
26,
22,
21,
13,
09,
20,
13,
15,
01,
26,
23,

2007
2008
2007
2010
2009
2009
2011
2007
2007
2010
2011
2011
2010
2010
2009
2009

15MG BASE/ML

N019675 001

Dec 30, 1988

150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG

A077824
A077824
A074680
A074680
A076705
A076705
A078542
A078542
A075165
A075165
A074023
A074023
A075180
A075180
A074467

Oct
Oct
Sep
Sep
Jul
Jul
Nov
Nov
Sep
Sep
Aug
Aug
Jan
Jan
Aug

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001

13,
13,
12,
12,
27,
27,
19,
19,
30,
30,
22,
22,
28,
28,
29,

2006
2006
1997
1997
2005
2005
2008
2008
1998
1998
1997
1997
1999
1999
1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 358 (of 424)

RANITIDINE HYDROCHLORIDE
TABLET; ORAL
RANITIDINE HYDROCHLORIDE
SANDOZ
AB
EQ 300MG
TEVA
AB
EQ 150MG
AB
EQ 300MG
WATSON LABS
AB
EQ 150MG
AB
EQ 150MG
AB
EQ 300MG
AB
EQ 300MG
WOCKHARDT
AB
EQ 150MG
AB
EQ 150MG
AB
EQ 300MG
AB
EQ 300MG
ZANTAC 150
GLAXOSMITHKLINE
AB
EQ 150MG
ZANTAC 300
AB + GLAXOSMITHKLINE
EQ 300MG

29,
31,
31,
20,
19,
20,
19,
17,
12,
17,
11,

1997
1997
1997
1997
2005
1997
2005
1998
2009
1998
2009

A074467
A074488
A074488
A074864
A077426
A074864
A077426
A075208
A078701
A075208
A078701

BASE

N018703 001

Jun 09, 1983

BASE

N018703 002

Dec 09, 1985

N020251 003

Apr 01, 2004

N021526 002
N021526 001

Jan 27, 2006

Feb 12, 2007

EQ 0.5MG BASE
EQ 1MG BASE

N021641 001
N021641 002

May 16, 2006

May 16, 2006

0.4MG/5ML (0.08MG/ML)

N022161 001

Apr 10, 2008

EQ 1MG BASE/VIAL
EQ 2MG BASE/VIAL
EQ 5MG BASE/VIAL

N020630 001
N020630 002
N020630 003

Jul 12, 1996

Jul 12, 1996
Jul 12, 1996

0.5MG
1MG
2MG

N020741 001
N020741 002
N020741 003

Dec 22, 1997

Dec 22, 1997
Dec 22, 1997

0.1MG
0.25MG

N009838 001
N009838 002

TABLET, EFFERVESCENT; ORAL

ZANTAC 25

EQ 25MG BASE
XX + GLAXOSMITHKLINE

002
001
002
001
001
002
002
001
001
002
002

Aug
Jul
Jul
Oct
Dec
Oct
Dec
Dec
Nov
Dec
Dec

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

RANOLAZINE
TABLET, EXTENDED RELEASE; ORAL
RANEXA
GILEAD
500MG
XX
1GM
XX +

RASAGILINE MESYLATE
TABLET; ORAL
AZILECT
TEVA
XX
XX +

REGADENOSON
SOLUTION; INTRAVENOUS

LEXISCAN

XX + ASTELLAS

REMIFENTANIL HYDROCHLORIDE
INJECTABLE; INJECTION

ULTIVA

MYLAN INSTITUTIONAL
XX
XX
XX +

REPAGLINIDE
TABLET; ORAL
PRANDIN
NOVO NORDISK INC
XX
XX
XX +

RESERPINE
TABLET; ORAL
RESERPINE
BP
SANDOZ
BP +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 359 (of 424)

RESERPINE
TABLET; ORAL
SERPALAN
BP
LANNETT
BP

0.1MG
0.25MG

N010124 001
N010124 002

1%

N022055 001

Apr 12, 2007

200MG

N020903 002

Jul 25, 2001

200MG

A076203 001

Apr 06, 2004

200MG

A079117 001

Sep 17, 2009

200MG
200MG
200MG

A076192 001
A076277 001
A077224 001

Apr 06, 2004

Oct 04, 2004
Oct 28, 2005

200MG

N020903 001

Jun 03, 1998

FOR SOLUTION; INHALATION

VIRAZOLE

XX + VALEANT PHARM INTL

6GM/VIAL

N018859 001

Dec 31, 1985

SOLUTION; ORAL

REBETOL

XX + SCHERING

40MG/ML

N021546 001

Jul 29, 2003

200MG

N021511 001

Dec 03, 2002

200MG
200MG
200MG
200MG
400MG
600MG
200MG
400MG
600MG

A079111
A077743
A077053
A077456
A077456
A077456
A077094
A077094
A077094

Sep
Oct
Dec
Dec
Dec
Dec
Dec
Mar
Mar

500MG

A077094 004

Apr 18, 2008

150MG

N050689 001

Dec 23, 1992

150MG
300MG

A062303 001
N050420 001

150MG

A065390 001

RETAPAMULIN
OINTMENT; TOPICAL

ALTABAX

XX + GLAXO GRP LTD

RIBAVIRIN

AB
AB
AB
AB
AB
AB
XX

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
XX

CAPSULE; ORAL
REBETOL
+ SCHERING PLOUGH RES
RIBASPHERE
THREE RIVERS PHARMS
RIBAVARIN
AUROBINDO PHARMA
RIBAVIRIN
SANDOZ
TEVA
ZYDUS PHARMS USA
REBETOL
+ SCHERING PLOUGH RES

TABLET; ORAL
COPEGUS
ROCHE
RIBAVIRIN
AUROBINDO PHARMA
SANDOZ
TEVA
THREE RIVERS PHARMS
+
ZYDUS PHARMS USA

RIBAVIRIN
ZYDUS PHARMS USA

001
001
001
001
002
003
001
002
003

17,
03,
05,
05,
05,
05,
05,
16,
16,

2009
2006
2005
2005
2005
2005
2005
2007
2007

RIFABUTIN
CAPSULE; ORAL

MYCOBUTIN

XX + PHARMACIA AND UPJOHN

RIFAMPIN
CAPSULE; ORAL
RIFADIN
SANOFI AVENTIS US
AB
AB +
RIFAMPIN
LANNETT
AB

Mar 28, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 360 (of 424)

RIFAMPIN
CAPSULE; ORAL
RIFAMPIN
LANNETT
AB
SANDOZ
AB
AB
VERSAPHARM
AB
AB

AP
AP
AP
AP

INJECTABLE; INJECTION
RIFADIN
+ SANOFI AVENTIS US
RIFAMPIN
BEDFORD
PFIZER
VERSAPHARM INC

002
002
001
001
002

Mar
Jan
May
Mar
Mar

28,
02,
28,
14,
14,

2008
1998
1997
2001
2001

300MG
150MG
300MG
150MG
300MG

A065390
A064150
A064150
A065028
A065028

600MG/VIAL

N050627 001

May 25, 1989

600MG/VIAL
600MG/VIAL
600MG/VIAL

A064217 001
A065421 001
A065502 001

Oct 29, 1999

May 22, 2008
Sep 21, 2010

150MG

N021024 001

Jun 22, 1998

200MG
550MG

N021361 001
N022554 001

May 25, 2004

Mar 24, 2010

EQ 25MG BASE

N202022 001

May 20, 2011

50MG

N020599 001

Dec 12, 1995

50MG

A076173 001

Jan 29, 2003

N019649 001

Sep 17, 1993

A075916 001
A076132 001

Nov 02, 2001

Aug 30, 2002

N020474 001

Dec 30, 1994

N020835 002
N020835 001
N020835 003

Apr 14, 2000

Mar 27, 1998
May 25, 2002

RIFAPENTINE
TABLET; ORAL

PRIFTIN

XX + SANOFI AVENTIS US

RIFAXIMIN
TABLET; ORAL

XIFAXAN

XX + SALIX PHARMS
XX +

RILPIVIRINE HYDROCHLORIDE
TABLET; ORAL

EDURANT

XX + TIBOTEC

RILUZOLE
TABLET; ORAL
RILUTEK
AB + SANOFI AVENTIS US
RILUZOLE
IMPAX LABS
AB

RIMANTADINE HYDROCHLORIDE
TABLET; ORAL
FLUMADINE
AB + CARACO
100MG
RIMANTADINE HYDROCHLORIDE
COREPHARMA
AB
100MG
IMPAX LABS
AB
100MG

RIMEXOLONE
SUSPENSION/DROPS; OPHTHALMIC

VEXOL

XX + ALCON
1%

RISEDRONATE SODIUM
TABLET; ORAL
ACTONEL
WARNER CHILCOTT
AB
AB
AB +

5MG
30MG
35MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 361 (of 424)

RISEDRONATE SODIUM
TABLET; ORAL
RISEDRONATE SODIUM
TEVA PHARMS
AB
AB
AB
ACTONEL
XX + WARNER CHILCOTT

5MG
30MG
35MG

A077132 001
A077132 002
A077132 003

Oct 05, 2007

Oct 05, 2007
Oct 05, 2007

150MG

N020835 005

Apr 22, 2008

N022560 001

Oct 08, 2010

N021346
N021346
N021346
N021346

Apr
Oct
Oct
Oct

TABLET, DELAYED RELEASE; ORAL

ATELVIA

35MG
XX + WARNER CHILCOTT

RISPERIDONE
INJECTABLE; INTRAMUSCULAR
RISPERDAL CONSTA
JANSSEN PHARMS
12.5MG/VIAL
XX
25MG/VIAL
XX +
37.5MG/VIAL
XX
50MG/VIAL
XX

AA
AA
AA
AA
AA
AA
AA
AA
AA
AA
AA

SOLUTION; ORAL
RISPERDAL
+ JANSSEN PHARMS
RISPERIDONE
AMNEAL PHARMS
APOTEX INC
AUROBINDO PHARMA
DR REDDYS LABS LTD
PRECISION DOSE
ROXANE
TARO
TEVA
VINTAGE
WOCKHARDT

TABLET; ORAL
RISPERDAL
JANSSEN PHARMS
AB
AB
AB +
AB
AB
AB
RISPERIDONE
AJANTA PHARMA LTD
AB
AB
AB
AB
AB
AB
APOTEX INC
AB
AB
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
AB
AB

004
001
002
003

12,
29,
29,
29,

2007
2003
2003
2003

1MG/ML

N020588 001

Jun 10, 1996

1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML

A091384
A077719
A078452
A078909
A076797
A076904
A090347
A076440
A079158
A078744

001
001
001
001
001
001
001
001
001
001

May
Jul
Sep
Jul
Jun
Jul
Feb
Jan
Dec
Oct

25,
29,
04,
29,
28,
29,
07,
30,
03,
08,

2011
2009
2009
2009
2010
2009
2011
2009
2010
2009

0.25MG
0.5MG
1MG
2MG
3MG
4MG

N020272
N020272
N020272
N020272
N020272
N020272

008
007
001
002
003
004

May
Jan
Dec
Dec
Dec
Dec

10,
27,
29,
29,
29,
29,

1999
1999
1993
1993
1993
1993

0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG

A201003
A201003
A201003
A201003
A201003
A201003
A077953
A077953
A077953
A077953
A077953
A077953
A078269
A078269
A078269
A078269
A078269
A078269

001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006

Aug
Aug
Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep
Sep
Sep
Oct
Oct
Oct
Oct
Oct
Oct

24,
24,
24,
24,
24,
24,
15,
15,
15,
15,
15,
15,
08,
08,
08,
08,
08,
08,

2011
2011
2011
2011
2011
2011
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 362 (of 424)

RISPERIDONE
TABLET; ORAL
RISPERIDONE
CIPLA
AB
AB
AB
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
PLIVA HRVATSKA DOO
AB
AB
AB
AB
AB
AB
PRINSTON INC
AB
AB
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
AB
AB
TORRENT PHARMS
AB
AB
AB
AB
AB
AB
VINTAGE
AB
AB
AB
AB
AB
AB
WATSON LABS
AB
AB
AB

0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG

A077543
A077543
A077543
A077543
A077543
A077543
A076879
A076879
A076879
A076879
A076879
A076879
A076288
A076288
A076288
A076288
A076288
A076288
A077769
A077769
A077769
A077769
A077769
A077769
A077493
A077493
A077493
A077493
A077493
A077493
A078528
A078528
A078528
A078528
A078528
A078528
A076228
A076228
A076228
A076228
A076228
A076228
A079088
A079088
A079088
A079088
A079088
A079088
A078707
A078707
A078707
A078707
A078707
A078707
A077860
A077860
A077860

001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003

May
May
May
May
May
May
Oct
Oct
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Sep
Oct
Oct
Oct
Oct
Oct
Oct
Nov
Nov
Nov
Nov
Nov
Nov
Oct
Oct
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Oct
Oct
Oct
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

18,
18,
18,
18,
18,
18,
24,
24,
24,
24,
24,
24,
15,
15,
15,
15,
15,
15,
16,
16,
16,
16,
16,
16,
29,
29,
29,
29,
29,
29,
16,
16,
16,
16,
16,
16,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
29,
29,
29,
29,
29,
29,
05,
05,
05,

2011
2011
2011
2011
2011
2011
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2011
2011
2011
2011
2011
2011
2009
2009
2009
2009
2009
2009
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 363 (of 424)

RISPERIDONE
TABLET; ORAL
RISPERIDONE
WATSON LABS
AB
AB
AB
WEST WARD PHARMS
AB
AB
AB
AB
AB
AB
WOCKHARDT
AB
AB
AB
AB
AB
AB
ZYDUS PHARMS USA INC
AB
AB
AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG

TABLET, ORALLY DISINTEGRATING; ORAL

RISPERDAL
JANSSEN PHARMS
0.5MG
+
1MG
2MG
3MG
4MG
RISPERIDONE
DR REDDYS LABS LTD
0.5MG
1MG
2MG
JUBILANT ORGANOSYS
0.5MG
1MG
2MG
3MG
4MG
MYLAN
0.5MG
1MG
2MG
3MG
4MG
PAR PHARM
0.5MG
1MG
2MG
3MG
4MG
RANBAXY
0.5MG
1MG
2MG
3MG
4MG
SANDOZ
0.5MG
1MG
2MG
3MG
4MG

A077860
A077860
A077860
A078740
A078740
A078740
A078740
A078740
A078740
A078871
A078871
A078871
A078871
A078871
A078871
A078040
A078040
A078040
A078040
A078040
A078040

004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006

Dec
Dec
Dec
May
May
May
May
May
May
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

05,
05,
05,
29,
29,
29,
29,
29,
29,
09,
09,
09,
09,
09,
09,
16,
16,
16,
16,
16,
16,

2008
2008
2008
2009
2009
2009
2009
2009
2009
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008

N021444
N021444
N021444
N021444
N021444

001
002
003
004
005

Apr
Apr
Apr
Dec
Dec

02,
02,
02,
23,
23,

2003
2003
2003
2004
2004

A077328
A077328
A077328
A090839
A090839
A090839
A090839
A090839
A091537
A091537
A091537
A091537
A091537
A077494
A077494
A077494
A077494
A077494
A077542
A077542
A077542
A078474
A078474
A078116
A078116
A078116
A078116
A078116

001
002
003
001
002
003
004
005
001
002
003
004
005
002
003
004
005
006
001
002
003
001
002
001
002
003
004
005

Feb
Oct
Feb
Nov
Nov
Nov
Nov
Nov
Mar
Mar
Mar
Mar
Mar
Apr
Oct
Apr
Apr
Apr
Aug
Aug
Aug
Aug
Aug
Dec
Dec
Dec
Dec
Dec

24,
05,
24,
04,
04,
04,
04,
04,
30,
30,
30,
30,
30,
30,
26,
30,
30,
30,
06,
06,
06,
06,
06,
22,
22,
22,
22,
22,

2009
2009
2009
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2009
2009
2009
2009
2009
2010
2010
2010
2010
2010
2009
2009
2009
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 364 (of 424)

RISPERIDONE

AB
AB
AB
AB
AB
AB
AB
XX

TABLET, ORALLY DISINTEGRATING; ORAL

RISPERIDONE
WATSON LABS FLORIDA
0.5MG
1MG
2MG
3MG
4MG
ZYDUS PHARMS USA
0.5MG
2MG
RISPERIDONE
PAR PHARM
0.25MG

A076996
A076996
A076996
A076996
A076996
A078516
A078516

001
002
003
004
005
001
003

Apr
Apr
Apr
Apr
Apr
May
May

19,
19,
19,
19,
19,
01,
01,

2011
2011
2011
2011
2011
2009
2009

A077494 001

Apr 30, 2009

RITONAVIR
CAPSULE; ORAL

NORVIR

XX + ABBOTT

100MG

N020945 001

Jun 29, 1999

SOLUTION; ORAL

NORVIR

XX + ABBOTT

80MG/ML

N020659 001

Mar 01, 1996

TABLET; ORAL

NORVIR

XX + ABBOTT LABS

100MG

N022417 001

Feb 10, 2010

10MG
15MG
20MG

N022406 001
N202439 001
N202439 002

Jul 01, 2011

Nov 04, 2011
Nov 04, 2011

N022083 001
N022083 002

Jul 06, 2007

Jul 06, 2007

RIVAROXABAN
TABLET; ORAL

XARELTO

XX + JANSSEN PHARMS
XX
XX +

RIVASTIGMINE
FILM, EXTENDED RELEASE; TRANSDERMAL
EXELON
XX
NOVARTIS
4.6MG/24HR
XX +
9.5MG/24HR

RIVASTIGMINE TARTRATE
CAPSULE; ORAL
EXELON
AB + NOVARTIS
AB
AB
AB
RIVASTIGMINE TARTRATE
DR REDDYS LABS INC
AB
AB
AB
AB
SUN PHARM INDS
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
AB

EQ
EQ
EQ
EQ

1.5MG BASE
3MG BASE
4.5MG BASE
6MG BASE

N020823
N020823
N020823
N020823

003
004
005
006

Apr
Apr
Apr
Apr

21,
21,
21,
21,

2000
2000
2000
2000

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

1.5MG BASE
3MG BASE
4.5MG BASE
6MG BASE
1.5MG BASE
3MG BASE
4.5MG BASE
6MG BASE
1.5MG BASE
3MG BASE
4.5MG BASE
6MG BASE

A077130
A077130
A077130
A077130
A077131
A077131
A077131
A077131
A077129
A077129
A077129
A077129

001
002
003
004
001
002
003
004
001
002
003
004

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Jan
Jan
Jan
Jan

31,
31,
31,
31,
22,
22,
22,
22,
08,
08,
08,
08,

2007
2007
2007
2007
2007
2007
2007
2007
2008
2008
2008
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 365 (of 424)

RIVASTIGMINE TARTRATE
SOLUTION; ORAL

EXELON

XX + NOVARTIS

EQ 2MG BASE/ML

N021025 001

Apr 21, 2000

EQ 5MG BASE
EQ 10MG BASE

N020864 001
N020864 002

Jun 29, 1998

Jun 29, 1998

TABLET, ORALLY DISINTEGRATING; ORAL

MAXALT-MLT
XX
MERCK
EQ 5MG BASE
XX +
EQ 10MG BASE

N020865 001
N020865 002

Jun 29, 1998

Jun 29, 1998

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

A078651
A078651
A079199
A079199
A078519
A078519
A091458
A091458
A079195
A079195
A078717
A078717

Dec
Dec
Nov
Nov
Nov
Nov
Jul
Jul
Dec
Dec
Nov
Nov

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

N020214 001
N020214 003

Mar 17, 1994

Mar 17, 1994

500MCG

N022522 001

Feb 28, 2011

10MG/VIAL

N022393 001

Nov 05, 2009

0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE

N020658
N020658
N020658
N020658
N020658
N020658
N020658

001
002
003
004
006
007
005

Sep
Sep
Sep
Sep
Jan
Jan
Sep

19,
19,
19,
19,
27,
27,
19,

1997
1997
1997
1997
1999
1999
1997

0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE

A090429
A090429
A090429
A090429

001
002
003
004

Mar
Mar
Mar
Mar

24,
24,
24,
24,

2010
2010
2010
2010

RIZATRIPTAN BENZOATE
TABLET; ORAL
MAXALT
MERCK
XX
XX +

ROCURONIUM BROMIDE
INJECTABLE; INJECTION
ROCURONIUM BROMIDE
APP PHARMS
AP
AP
BIONICHE PHARMA USA
AP
AP
HOSPIRA
AP
AP
SAGENT STRIDES
AP
AP
SANDOZ
AP
AP
TEVA PARENTERAL
AP
AP
ZEMURON
AP + SCHERING
AP +

001
002
001
002
001
002
001
002
001
002
001
002

29,
29,
26,
26,
26,
26,
28,
28,
05,
05,
26,
26,

2008
2008
2008
2008
2008
2008
2010
2010
2008
2008
2008
2008

ROFLUMILAST
TABLET; ORAL

DALIRESP

XX + FOREST RES INST INC

ROMIDEPSIN
POWDER; IV (INFUSION)

ISTODAX

XX + CELGENE

ROPINIROLE HYDROCHLORIDE
TABLET; ORAL
REQUIP
AB + GLAXOSMITHKLINE
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
AB
EQ
ROPINIROLE HYDROCHLORIDE
ALEMBIC LTD
AB
EQ
AB
EQ
AB
EQ
AB
EQ

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 366 (of 424)

ROPINIROLE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
ROPINIROLE HYDROCHLORIDE
ALEMBIC LTD
EQ
EQ
EQ
COREPHARMA
EQ
EQ
EQ
EQ
EQ
EQ
EQ
GLENMARK GENERICS
EQ
EQ
EQ
EQ
EQ
EQ
EQ
MYLAN
EQ
EQ
EQ
EQ
EQ
EQ
EQ
PRINSTON INC
EQ
EQ
EQ
EQ
EQ
EQ
EQ
ROXANE
EQ
EQ
EQ
EQ
EQ
EQ
EQ
TEVA
EQ
EQ
EQ
EQ
EQ
EQ
EQ
WOCKHARDT
EQ
EQ
EQ
EQ
EQ
EQ
EQ
ZYDUS PHARMS USA INC EQ
EQ
EQ
EQ
EQ

3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE
0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE

A090429
A090429
A090429
A078230
A078230
A078230
A078230
A078230
A078230
A078230
A090135
A090135
A090135
A090135
A090135
A090135
A090135
A078881
A078881
A078881
A078881
A078881
A078881
A078881
A078110
A078110
A078110
A078110
A078110
A078110
A078110
A077852
A077852
A077852
A077852
A077852
A077852
A077852
A077460
A077460
A077460
A077460
A077460
A077460
A077460
A079050
A079050
A079050
A079050
A079050
A079050
A079050
A090411
A090411
A090411
A090411
A090411

005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004
005

Mar
Mar
Mar
May
May
May
May
May
May
May
Feb
Feb
Feb
Feb
Feb
Feb
Feb
May
May
May
May
May
May
May
May
May
May
May
May
May
Jul
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
Jun
Jun
Jun
Jun
Jun

24,
24,
24,
20,
20,
20,
20,
20,
20,
20,
25,
25,
25,
25,
25,
25,
25,
05,
05,
05,
05,
05,
05,
19,
05,
05,
05,
05,
05,
05,
11,
05,
05,
05,
05,
05,
05,
19,
05,
05,
05,
05,
05,
05,
19,
29,
29,
29,
29,
29,
29,
29,
01,
01,
01,
01,
01,

2010
2010
2010
2008
2008
2008
2008
2008
2008
2008
2010
2010
2010
2010
2010
2010
2010
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2009
2009
2009
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 367 (of 424)

ROPINIROLE HYDROCHLORIDE
TABLET; ORAL
ROPINIROLE HYDROCHLORIDE
ZYDUS PHARMS USA INC EQ 4MG BASE
AB
AB
EQ 5MG BASE

A090411 006
A090411 007

Jun 01, 2009

Jun 01, 2009

TABLET, EXTENDED RELEASE; ORAL

REQUIP XL

EQ 2MG BASE
XX + SMITHKLINE BEECHAM
EQ 4MG BASE
XX
EQ 6MG BASE
XX
EQ 8MG BASE
XX
EQ 12MG BASE
XX

N022008
N022008
N022008
N022008
N022008

001
003
006
004
005

Jun
Jun
Apr
Jun
Oct

13,
13,
10,
13,
31,

2008
2008
2009
2008
2008

2MG/ML
5MG/ML
7.5MG/ML
10MG/ML

N020533
N020533
N020533
N020533

001
003
004
005

Sep
Sep
Sep
Sep

24,
24,
24,
24,

1996
1996
1996
1996

EQ 2MG BASE
EQ 4MG BASE
EQ 8MG BASE

N021071 002
N021071 003
N021071 004

May 25, 1999

May 25, 1999
May 25, 1999

5MG
10MG
20MG
40MG

N021366
N021366
N021366
N021366

Aug
Aug
Aug
Aug

N/A

N019414 001

Dec 29, 1989

SUSPENSION; ORAL

BANZEL

XX + EISAI INC

40MG/ML

N201367 001

Mar 03, 2011

TABLET; ORAL
BANZEL
XX
EISAI INC
XX +

200MG
400MG

N021911 002
N021911 003

Nov 14, 2008

Nov 14, 2008

EQ
EQ
EQ
EQ
EQ

N202192
N202192
N202192
N202192
N202192

Nov
Nov
Nov
Nov
Nov

ROPIVACAINE HYDROCHLORIDE MONOHYDRATE

INJECTABLE; INJECTION
NAROPIN
APP PHARMS
XX
XX
XX
XX +

ROSIGLITAZONE MALEATE
TABLET; ORAL
AVANDIA
SB PHARMCO
XX
XX
XX +

ROSUVASTATIN CALCIUM
TABLET; ORAL
CRESTOR
XX
IPR
XX
XX
XX +

002
003
004
005

12,
12,
12,
12,

2003
2003
2003
2003

RUBIDIUM CHLORIDE RB-82

INJECTABLE; INJECTION
CARDIOGEN-82
BRACCO
XX

RUFINAMIDE

RUXOLITINIB PHOSPHATE
TABLET; ORAL
JAKAFI
INCYTE CORP
XX
XX
XX
XX
XX +

5MG BASE
10MG BASE
15MG BASE
20MG BASE
25MG BASE

001
002
003
004
005

16,
16,
16,
16,
16,

2011
2011
2011
2011
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 368 (of 424)

SACROSIDASE
SOLUTION; ORAL

SUCRAID

XX + QOL MEDCL

8,500 IU/ML

N020772 001

Apr 09, 1998

5%;5% (5GM/100ML)

N018997 001

Aug 27, 1984

10%;10% (10GM/100ML)

N018991 001

Aug 27, 1984

EQ 0.05MG BASE/INH

N020692 001

Sep 19, 1997

N020570 001

Mar 28, 1997

100MG

N022181 001

Dec 13, 2007

CAPSULE; ORAL

INVIRASE

XX + HOFFMANN LA ROCHE

EQ 200MG BASE

N020628 001

Dec 06, 1995

TABLET; ORAL

INVIRASE

XX + ROCHE

EQ 500MG BASE

N021785 001

Dec 17, 2004

EQ 2.5MG BASE
EQ 5MG BASE

N022350 001
N022350 002

Jul 31, 2009

Jul 31, 2009

SAFFLOWER OIL; SOYBEAN OIL

INJECTABLE; INJECTION

LIPOSYN II 10%

XX + HOSPIRA
LIPOSYN II 20%
XX + HOSPIRA

SALMETEROL XINAFOATE
POWDER; INHALATION

SEREVENT

XX + GLAXO GRP LTD

SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

INJECTABLE; INJECTION

QUADRAMET

XX + EUSA PHARMA USA

50mCi/ML

SAPROPTERIN DIHYDROCHLORIDE
TABLET; ORAL

KUVAN

XX + BIOMARIN PHARM

SAQUINAVIR MESYLATE

SAXAGLIPTIN HYDROCHLORIDE
TABLET; ORAL

ONGLYZA

BRISTOL MYERS SQUIBB

XX
XX +

SCOPOLAMINE
FILM, EXTENDED RELEASE; TRANSDERMAL

TRANSDERM SCOP

1MG/72HR
XX + NOVARTIS

N017874 001

SECOBARBITAL SODIUM
CAPSULE; ORAL

SECONAL SODIUM

XX + MARATHON PHARMS
XX +

50MG
100MG

A086101 001
A086101 002

Oct 03, 1983

Oct 03, 1983

N021256 001
N021256 002

Apr 09, 2004

Jun 21, 2007

SECRETIN SYNTHETIC HUMAN

FOR SOLUTION; INTRAVENOUS

CHIRHOSTIM

16MCG/VIAL
XX + CHIRHOCLIN
40MCG/VIAL
XX

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 369 (of 424)

SELEGILINE
FILM, EXTENDED RELEASE; TRANSDERMAL

EMSAM

6MG/24HR
XX + SOMERSET
9MG/24HR
XX
12MG/24HR
XX

N021336 001
N021336 002
N021336 003

Feb 27, 2006

Feb 27, 2006
Feb 27, 2006

N020647 001

May 15, 1996

A075321 001
A075352 001

Dec 04, 1998

Nov 30, 1998

A074871
A074641
A074866
A074912

Jun
Aug
Nov
Apr

SELEGILINE HYDROCHLORIDE
CAPSULE; ORAL
ELDEPRYL
AB + SOMERSET
5MG
SELEGILINE HYDROCHLORIDE
APOTEX
AB
5MG
DAVA PHARMS INC
AB
5MG

AB
AB
AB
AB

TABLET; ORAL
SELEGILINE HYDROCHLORIDE
+ APOTEX INC
5MG
DAVA PHARMS INC
5MG
MYLAN
5MG
STASON
5MG

TABLET, ORALLY DISINTEGRATING; ORAL

ZELAPAR

XX + VALEANT PHARM INTL 1.25MG

001
001
001
001

06,
02,
26,
30,

1997
1996
1997
1998

N021479 001

Jun 14, 2006

2.5%
2.5%

A089996 001
A088228 001

Jan 10, 1991

Sep 01, 1983

2.5%

N007936 001

2%

N021385 001

Dec 10, 2003

A078861 001
A078053 001

Oct 31, 2008

Feb 05, 2007

N020990 001

Dec 07, 1999

A076882
A076882
A076882
A077206
A077206
A077206
A078677
A078677
A078677
A076442
A076442
A076442
A077864

Feb
Feb
Feb
Feb
Feb
Feb
Mar
Mar
Mar
Apr
Apr
Apr
Aug

SELENIUM SULFIDE
LOTION/SHAMPOO; TOPICAL
SELENIUM SULFIDE
PERRIGO NEW YORK
AT
WOCKHARDT
AT
SELSUN
AT + CHATTEM

SERTACONAZOLE NITRATE
CREAM; TOPICAL

ERTACZO

XX + ORTHO JANSSEN

SERTRALINE HYDROCHLORIDE
CONCENTRATE; ORAL
SERTRALINE HYDROCHLORIDE
AUROBINDO PHARMA
AA
EQ 20MG BASE/ML
RANBAXY
AA
EQ 20MG BASE/ML
ZOLOFT
AA + PFIZER
EQ 20MG BASE/ML

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
SERTRALINE HYDROCHLORIDE
APOTEX INC
EQ
EQ
EQ
AUROBINDO PHARMA
EQ
EQ
EQ
AUSTARPHARMA LLC
EQ
EQ
EQ
DR REDDYS LABS LTD
EQ
EQ
EQ
HIKMA PHARMS
EQ

25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE

001
002
003
001
002
003
001
002
003
001
002
003
001

06,
06,
06,
06,
06,
06,
04,
04,
04,
30,
30,
30,
10,

2007
2007
2007
2007
2007
2007
2009
2009
2009
2007
2007
2007
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 370 (of 424)

SERTRALINE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
XX
XX

TABLET; ORAL
SERTRALINE HYDROCHLORIDE
HIKMA PHARMS
EQ
EQ
INVAGEN PHARMS
EQ
EQ
EQ
LUPIN
EQ
EQ
EQ
MATRIX LABS LTD
EQ
EQ
EQ
MYLAN
EQ
EQ
EQ
EQ
EQ
EQ
RANBAXY
EQ
EQ
EQ
SUN PHARM INDS (IN)
EQ
EQ
EQ
TEVA
EQ
EQ
EQ
TORRENT PHARMS
EQ
EQ
EQ
WATSON LABS
EQ
EQ
EQ
WOCKHARDT
EQ
EQ
EQ
ZYDUS PHARMS USA
EQ
EQ
EQ
ZOLOFT
PFIZER
EQ
EQ
+
EQ
SERTRALINE HYDROCHLORIDE
RANBAXY
EQ
EQ

002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Aug
Aug
Feb
Feb
Feb
Feb
Feb
Feb
Jan
Jan
Jan
Mar
Feb
Mar
Feb
Mar
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Aug
Aug
Aug
Feb
Feb
Feb
Feb
Feb
Feb
Jan
Jan
Jan
Feb
Feb
Feb

10,
10,
06,
06,
06,
06,
06,
06,
31,
31,
31,
20,
06,
20,
06,
20,
06,
06,
06,
06,
06,
06,
06,
11,
11,
11,
06,
06,
06,
06,
06,
06,
08,
08,
08,
06,
06,
06,

2009
2009
2007
2007
2007
2007
2007
2007
2008
2008
2008
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2006
2006
2006
2007
2007
2007
2007
2007
2007
2008
2008
2008
2007
2007
2007

50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
25MG BASE
50MG BASE
50MG BASE
100MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE

A077864
A077864
A077397
A077397
A077397
A077670
A077670
A077670
A078626
A078626
A078626
A076540
A076671
A076540
A076671
A076540
A076671
A077977
A077977
A077977
A078108
A078108
A078108
A076465
A076465
A076465
A077765
A077765
A077765
A077663
A077663
A077663
A078403
A078403
A078403
A077106
A077106
A077106

25MG BASE
50MG BASE
100MG BASE

N019839 005
N019839 001
N019839 002

Mar 06, 1996

Dec 30, 1991
Dec 30, 1991

150MG BASE
200MG BASE

A077977 004
A077977 005

Feb 06, 2007

Feb 06, 2007

SEVELAMER CARBONATE
FOR SUSPENSION; ORAL
RENVELA
GENZYME
XX
XX +

800MG/PACKET
2.4GM/PACKET

N022318 001
N022318 002

Aug 12, 2009

Feb 18, 2009

TABLET; ORAL

RENVELA

XX + GENZYME

800MG

N022127 001

Oct 19, 2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 371 (of 424)

SEVELAMER HYDROCHLORIDE
TABLET; ORAL
RENAGEL
GENZYME
XX
XX +

400MG
800MG

N021179 001
N021179 002

Jul 12, 2000

Jul 12, 2000

100%
100%

A075895 001
A078650 001

Jul 02, 2002

Nov 19, 2007

100%

A077867 001

May 02, 2007

100%

N020478 001

Jun 07, 1995

EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)

N022473 001

Nov 18, 2009

EQ 20MG BASE

N021845 001

Jun 03, 2005

EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE

N020895 001
N020895 002
N020895 003

Mar 27, 1998

Mar 27, 1998
Mar 27, 1998

4MG
8MG

N022206 001
N022206 002

Oct 08, 2008

Oct 08, 2008

1%

N017381 001

1%

N018578 001

Feb 25, 1982

1%

N018810 001

Dec 23, 1985

1%

N018578 003

Jul 11, 1990

10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG

A078155
A078155
A078155
A078155
A077691
A077691
A077691
A077691
A077691
A078034
A078034

Feb
Feb
Feb
Feb
Dec
Dec
Dec
Dec
Dec
Dec
Dec

SEVOFLURANE

AN
AN
AN
AN

LIQUID; INHALATION
SEVOFLURANE
BAXTER HLTHCARE
HALOCARBON PRODS
SOJOURN
PIRAMAL CRITICAL
ULTANE
+ ABBOTT

SILDENAFIL CITRATE
SOLUTION; INTRAVENOUS

REVATIO

XX + PFIZER
TABLET; ORAL

REVATIO

XX + PFIZER
VIAGRA
PFIZER IRELAND
XX
XX
XX +

SILODOSIN
CAPSULE; ORAL
RAPAFLO
WATSON LABS
XX
XX +

SILVER SULFADIAZINE

AB
AB
AB
BX

CREAM; TOPICAL
SILVADENE
+ KING PHARMS
SSD
DR REDDYS LA
THERMAZENE
COVIDIEN
SSD AF
DR REDDYS LA

SIMVASTATIN
TABLET; ORAL
SIMVASTATIN
ACCORD HLTHCARE
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
AB
BLU CARIBE
AB
AB

002
003
004
001
001
002
003
004
005
001
002

26,
26,
26,
26,
20,
20,
20,
20,
20,
20,
20,

2008
2008
2008
2008
2006
2006
2006
2006
2006
2006
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 372 (of 424)

SIMVASTATIN
TABLET; ORAL
SIMVASTATIN
BLU CARIBE
AB
AB
AB
DR REDDYS LABS INC
AB
AB
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
AB
AB
LUPIN
AB
AB
AB
AB
AB
MATRIX LABS LTD
AB
AB
AB
AB
AB
MICRO LABS LTD
AB
AB
AB
AB
AB
RANBAXY
AB
AB
AB
AB
AB
WATSON LABS
AB
AB
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB
AB
AB
ZOCOR
MERCK
AB
AB
AB
AB
AB +

20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG

A078034
A078034
A078034
A077752
A077752
A077752
A077752
A077752
A076052
A076052
A076052
A076052
A076052
A078103
A078103
A078103
A078103
A078103
A090868
A090868
A090868
A090868
A090868
A090383
A090383
A090383
A090383
A090383
A076285
A076285
A076285
A076285
A076285
A076685
A076685
A076685
A076685
A076685
A077837
A077837
A077837
A077837
A077837

003
004
005
005
001
002
003
004
001
002
003
004
005
005
001
002
003
004
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005

Dec
Dec
Dec
Jan
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Dec
Apr
May
May
May
May
Jun
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Sep
Sep
Dec
Dec
Dec
Dec
Jun
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

20,
20,
20,
23,
20,
20,
20,
20,
23,
23,
23,
23,
20,
14,
11,
11,
11,
11,
08,
08,
08,
08,
08,
16,
16,
16,
16,
16,
20,
20,
20,
20,
23,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2006
2006
2006
2008
2006
2006
2006
2006
2006
2006
2006
2006
2006
2009
2007
2007
2007
2007
2010
2010
2010
2010
2010
2011
2011
2011
2011
2011
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006

5MG
10MG
20MG
40MG
80MG

N019766
N019766
N019766
N019766
N019766

001
002
003
004
005

Dec
Dec
Dec
Dec
Jul

23,
23,
23,
23,
10,

1991
1991
1991
1991
1998

SIMVASTATIN; SITAGLIPTIN PHOSPHATE

TABLET; ORAL
JUVISYNC
MERCK SHARP DOHME
XX
XX
XX +

10MG;EQ 100MG BASE

20MG;EQ 100MG BASE
40MG;EQ 100MG BASE

N202343 001
N202343 002
N202343 003

Oct 07, 2011

Oct 07, 2011
Oct 07, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 373 (of 424)

SINCALIDE
INJECTABLE; INJECTION

KINEVAC

XX + BRACCO

0.005MG/VIAL

N017697 001

15%

N021902 001

Oct 31, 2006

SOLUTION; ORAL

RAPAMUNE

XX + WYETH PHARMS INC

1MG/ML

N021083 001

Sep 15, 1999

TABLET; ORAL
RAPAMUNE
WYETH PHARMS INC
XX
XX
XX +

0.5MG
1MG
2MG

N021110 004
N021110 001
N021110 002

Jan 25, 2010

Aug 25, 2000
Aug 22, 2002

EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE

N021995 001
N021995 002
N021995 003

Oct 16, 2006

Oct 16, 2006
Oct 16, 2006

N018893 001

May 04, 1983

10%;10% (5GM/50ML;5GM/50ML)

N020645 001

Feb 17, 2005

0.9MEQ/ML
1MEQ/ML

A077394 001
A077394 002

Nov 09, 2005

Nov 09, 2005

A088911 001
N018800 001

Feb 07, 1985

Oct 29, 1982

N019635
N018016
N018090
N019759

001
001
001
001

Mar 09, 1988

A088912
N017464
N019635
N016677
N020178

001
001
002
004
002

Jan 10, 1985

SINECATECHINS
OINTMENT; TOPICAL

VEREGEN

XX + MEDIGENE AG

SIROLIMUS

SITAGLIPTIN PHOSPHATE
TABLET; ORAL
JANUVIA
MERCK CO INC
XX
XX
XX +

SODIUM ACETATE ANHYDROUS

INJECTABLE; INJECTION

SODIUM ACETATE IN PLASTIC CONTAINER

2MEQ/ML
XX + HOSPIRA

SODIUM BENZOATE; SODIUM PHENYLACETATE

SOLUTION; IV (INFUSION)

AMMONUL

XX + UCYCLYD

SODIUM BICARBONATE
INJECTABLE; INJECTION

SODIUM BICARBONATE

XX + HOSPIRA
XX +

SODIUM CHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
APP PHARMS
9MG/ML
+ HOSPIRA
9MG/ML
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
450MG/100ML
BAXTER HLTHCARE
450MG/100ML
HOSPIRA
450MG/100ML
450MG/100ML
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
9MG/ML
+ APP PHARMS
900MG/100ML
+ B BRAUN
900MG/100ML
+
9MG/ML
+ BAXTER HLTHCARE
9MG/ML

Jun 08, 1988

Mar 09, 1988

Oct 30, 1985
Dec 07, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 374 (of 424)

SODIUM CHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
XX
XX
XX
XX
XX

INJECTABLE; INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
900MG/100ML
+
900MG/100ML
FRESENIUS MEDCL
900MG/100ML
HAEMONETICS
900MG/100ML
+ HOSPIRA
9MG/ML
+
9MG/ML
9MG/ML
+
900MG/100ML
+
900MG/100ML
+
900MG/100ML
+ TARO PHARMS IRELAND
9MG/ML
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
+ MALLINCKRODT
45MG/50ML (9MG/ML)
112.5MG/125ML (9MG/ML)
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
BAXTER HLTHCARE
3GM/100ML
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML
SODIUM CHLORIDE IN PLASTIC CONTAINER
HOSPIRA
2.5MEQ/ML

SOLUTION FOR SLUSH; IRRIGATION

SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER
BAXTER HLTHCARE
900MG/100ML
XX

AT
AT
AT
AT
AT
AT

SOLUTION; IRRIGATION
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE
450MG/100ML
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
900MG/100ML
BAXTER HLTHCARE
900MG/100ML
900MG/100ML
HOSPIRA
900MG/100ML
900MG/100ML

N016677
N020178
A078177
A076316
N018803
N019217
N019465
N016366
N019465
N019480
A077407

001
001
001
001
001
001
002
001
001
001
001

Jul 15, 1985

Sep 17, 1985
Aug 11, 2006

N021569 001
N021569 002

Jul 27, 2006

Jul 27, 2006

N019022 001

Nov 01, 1983

N019022 002

Nov 01, 1983

N018897 001

Jul 20, 1984

N019319 002

May 17, 1985

Dec
Apr
Oct
Oct
Jul
Jul

07,
12,
27,
29,
13,
15,

1992
2007
2004
1982
1984
1985

N017864 001
N016733
N017427
N017867
N017514
N018314

001
001
001
001
001

SODIUM CHROMATE CR-51

INJECTABLE; INJECTION

CHROMITOPE SODIUM

XX
BRACCO

200uCi/ML

N013993 001

SODIUM FERRIC GLUCONATE COMPLEX

INJECTABLE; INJECTION
FERRLECIT
AB + SANOFI AVENTIS US
62.5MG/5ML
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
GENERAMEDIX
AB
62.5MG/5ML

N020955 001

Feb 18, 1999

A078215 001

Mar 31, 2011

Feb
Feb
May
May

SODIUM IODIDE I-123

CAPSULE; ORAL
SODIUM IODIDE I 123
AA + GE HEALTHCARE
MALLINCKRODT
AA
AA
AA + SYNCOR PHARMS
AA +

100uCi
100uCi
200uCi
100uCi
200uCi

N017630
A071909
A071910
N018671
N018671

SOLUTION; ORAL

SODIUM IODIDE I 123

XX + GE HEALTHCARE

2mCi/ML

N017630 002

001
001
001
001
002

28,
28,
27,
27,

1989
1989
1982
1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 375 (of 424)

SODIUM IODIDE I-131

CAPSULE; ORAL

SODIUM IODIDE I 131

XX + MALLINCKRODT
SODIUM IODIDE I-131

DRAXIMAGE
XX
XX

XX
XX
XX
XX

SOLUTION; ORAL

HICON

+ DRAXIMAGE
+
+
SODIUM IODIDE I 131
+ MALLINCKRODT

0.8-100mCi

N016517 001

9-100mCi
2-200mCi

N021305 006
N021305 004

May 19, 2005

Nov 18, 2004

1-1000mCi/ML
1-500mCi/0.5ML
1-250mCi/0.25ML

N021305 005
N021305 003
N021305 002

Apr 04, 2006

Jan 24, 2003
Jan 24, 2003

3.5-150mCi/VIAL

N016515 001

SODIUM LACTATE
INJECTABLE; INJECTION
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
BAXTER HLTHCARE
AP
1.87GM/100ML
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER
B BRAUN
AP
1.87GM/100ML
SODIUM LACTATE IN PLASTIC CONTAINER
5MEQ/ML
XX + HOSPIRA

N016692 001
N020004 001

Apr 21, 1992

N018947 001

Sep 05, 1984

N201444 001

Jan 14, 2011

25MG/ML

A071961 001

Aug 01, 1988

500MG/ML

N021196 001

Jul 17, 2002

3GM/TEASPOONFUL

N020573 001

Apr 30, 1996

500MG

N020572 001

May 13, 1996

500MG

A090910 001

Nov 18, 2011

SODIUM NITRITE; SODIUM THIOSULFATE

SOLUTION, SOLUTION; INTRAVENOUS, INTRAVENOUS

NITHIODOTE

300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML
XX + HOPE PHARMS
(250MG/ML)

SODIUM NITROPRUSSIDE
INJECTABLE; INJECTION

NITROPRESS

XX + HOSPIRA

SODIUM OXYBATE
SOLUTION; ORAL

XYREM

XX + JAZZ

SODIUM PHENYLBUTYRATE
POWDER; ORAL

BUPHENYL

XX + MEDICIS
TABLET; ORAL
BUPHENYL
AB + MEDICIS
SODIUM PHENYLBUTYRATE
AMPOLGEN
AB

SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET; ORAL

VISICOL

XX + 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
AB
0.398GM;1.102GM

A079247 001

Dec 30, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 376 (of 424)

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET; ORAL
OSMOPREP
AB + 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
XX

N018892 001

May 10, 1983

A040905 001

Mar 30, 2009

SODIUM POLYSTYRENE SULFONATE

AA
AA
AA
AA
AA
AA

AA
AA
AA
AA

POWDER; ORAL, RECTAL

KALEXATE
KVK TECH
454GM/BOT
KAYEXALATE
+ SANOFI AVENTIS US
453.6GM/BOT
KIONEX
PADDOCK LLC
454GM/BOT
SODIUM POLYSTYRENE SULFONATE
CAROLINA MEDCL
454GM/BOT
CEDAR PHARMS
453.6GM/BOT
CITRUSPHRMA
454GM/BOT

N011287 001
A040029 001

Feb 06, 1998

A089910 001
A090313 001
A040909 001

Jan 19, 1989

Dec 21, 2011
Dec 03, 2008

A040028 001

Sep 17, 2007

A090590 001
A089049 001

May 13, 2011

Nov 17, 1986

A087859 001

Dec 08, 1982

20MG/2ML (10MG/ML)
60MG/2ML (30MG/ML)

A040541 001
A040541 002

Nov 12, 2004

Nov 12, 2004

5MG
10MG

N021518 001
N021518 002

Nov 19, 2004

Nov 19, 2004

5.8MG/VIAL
FREE
1.5MG/VIAL

N020280 006

Aug 24, 1995

N020280 004

Aug 24, 1995

5MG/VIAL
6MG/VIAL

N019640 004
N019640 005

Mar 08, 1987

Feb 04, 1999

5MG/1.5ML
10MG/1.5ML

N021148 001
N021148 002

Jun 20, 2000

Jun 20, 2000

5MG/1.5ML
10MG/1.5ML

N021148 008
N021148 009

Mar 01, 2010

Mar 01, 2010

5MG/1.5ML

N021148 004

Oct 01, 2004

SUSPENSION; ORAL, RECTAL

KIONEX
PADDOCK LLC
15GM/60ML
SODIUM POLYSTYRENE SULFONATE
PADDOCK LLC
15GM/60ML
ROXANE
15GM/60ML
SPS
+ CAROLINA MEDCL
15GM/60ML

SODIUM TETRADECYL SULFATE

INJECTABLE; INJECTION
SOTRADECOL
BIONICHE PHARMA
XX
XX +

SOLIFENACIN SUCCINATE
TABLET; ORAL
VESICARE
ASTELLAS
XX
XX +

SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION
GENOTROPIN
BX + PHARMACIA AND UPJOHN
GENOTROPIN PRESERVATIVE
BX
PHARMACIA AND UPJOHN
HUMATROPE
BX + LILLY
BX
NORDITROPIN
BX
NOVO NORDISK INC
BX
NORDITROPIN FLEXPRO
BX
NOVO NORDISK INC
BX
NORDITROPIN NORDIFLEX
BX
NOVO NORDISK INC

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 377 (of 424)

SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION
NORDITROPIN NORDIFLEX
BX
NOVO NORDISK INC
NUTROPIN
BX
GENENTECH
OMNITROPE
BX
SANDOZ
BX
BX
BX
SAIZEN
BX
EMD SERONO
SEROSTIM
BX
EMD SERONO
BX
BX
TEV-TROPIN
BX + FERRING
VALTROPIN
BX
LG LIFE
GENOTROPIN
XX + PHARMACIA AND UPJOHN
GENOTROPIN PRESERVATIVE
PHARMACIA AND UPJOHN
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX +
HUMATROPE
XX + LILLY
XX +
NORDITROPIN
XX + NOVO NORDISK INC
NORDITROPIN FLEXPRO
NOVO NORDISK INC
XX
NORDITROPIN NORDIFLEX
NOVO NORDISK INC
XX
XX
NUTROPIN
XX + GENENTECH
NUTROPIN AQ
XX + GENENTECH
XX +
XX +
NUTROPIN AQ PEN
XX + GENENTECH
SAIZEN
XX + EMD SERONO
ZORBTIVE
XX + EMD SERONO

10MG/1.5ML

N021148 005

Oct 01, 2004

5MG/VIAL

N020168 001

Nov 17, 1993

1.5MG/VIAL
5MG/1.5ML
5.8MG/VIAL
10MG/1.5ML

N021426
N021426
N021426
N021426

May
Jan
May
Aug

5MG/VIAL

N019764 002

Oct 08, 1996

4MG/VIAL
5MG/VIAL
6MG/VIAL

N020604 003
N020604 002
N020604 001

Jul 25, 1997

Aug 23, 1996
Aug 23, 1996

5MG/VIAL

N019774 002

Jan 04, 2002

5MG/VIAL

N021905 001

Apr 19, 2007

13.8MG/VIAL
FREE
0.2MG/VIAL
0.4MG/VIAL
0.6MG/VIAL
0.8MG/VIAL
1MG/VIAL
1.2MG/VIAL
1.4MG/VIAL
1.6MG/VIAL
1.8MG/VIAL
2MG/VIAL

N020280 007

Oct 23, 1996

N020280
N020280
N020280
N020280
N020280
N020280
N020280
N020280
N020280
N020280

Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan

12MG/VIAL
24MG/VIAL

N019640 006
N019640 007

Feb 04, 1999

Feb 04, 1999

15MG/1.5ML

N021148 003

Jun 20, 2000

15MG/1.5ML

N021148 010

Mar 01, 2010

15MG/1.5ML
30MG/3ML

N021148 006
N021148 007

Oct 01, 2004

Mar 10, 2009

10MG/VIAL

N020168 002

Nov 17, 1993

5MG/2ML (2.5MG/ML)
10MG/2ML (5MG/ML)
20MG/2ML (10MG/ML)

N020522 003
N020522 001
N020522 004

Jan 03, 2008

Dec 29, 1995
Jan 03, 2008

10MG/2ML (5MG/ML)

N020522 002

Apr 22, 2002

8.8MG/VIAL

N019764 003

Aug 29, 2000

8.8MG/VIAL

N021597 004

Dec 01, 2003

EQ 200MG BASE

N021923 001

Dec 20, 2005

002
003
001
004

001
002
003
005
008
009
010
011
012
013

30,
16,
30,
25,

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,

2006
2008
2006
2008

1998
1998
1998
1998
1998
1998
1998
1998
1998
1998

SORAFENIB TOSYLATE
TABLET; ORAL

NEXAVAR

XX + BAYER HLTHCARE

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PRESCRIPTION DRUG PRODUCT LIST

3 - 378 (of 424)

SORBITOL
SOLUTION; IRRIGATION

SORBITOL 3% IN PLASTIC CONTAINER

BAXTER HLTHCARE
3GM/100ML
XX
SORBITOL 3.3% IN PLASTIC CONTAINER

B BRAUN
3.3GM/100ML
XX

N017863 001

N016741 001

SOTALOL HYDROCHLORIDE
SOLUTION; INTRAVENOUS

SOTALOL HYDROCHLORIDE

XX + ACADEMIC PHARMS
TABLET; ORAL
BETAPACE
BAYER HLTHCARE
AB1
AB1
AB1 +
AB1
SORINE
UPSHER SMITH
AB1
AB1
AB1
AB1
SOTALOL HYDROCHLORIDE
APOTEX INC
AB1
AB1
AB1
AB1
IMPAX PHARMS
AB1
AB1
AB1
AB1
MYLAN
AB1
AB1
AB1
AB1
AB1
AB1
AB1
AB1
SANDOZ
AB1
AB1
AB1
AB1
TEVA
AB1
AB1
AB1
AB1
VINTAGE PHARMS
AB1
AB1
AB1
AB1
BETAPACE AF
BAYER HLTHCARE
AB2
AB2
AB2 +
SOTALOL HYDROCHLORIDE
AMNEAL PHARM
AB2
AB2
AB2
APOTEX
AB2

150MG/10ML (15MG/ML)

N022306 001

Jul 02, 2009

80MG
120MG
160MG
240MG

N019865
N019865
N019865
N019865

001
005
002
003

Oct
Apr
Oct
Oct

30,
20,
30,
30,

1992
1994
1992
1992

80MG
120MG
160MG
240MG

A075500
A075500
A075500
A075500

001
004
002
003

Apr
Apr
Apr
Apr

27,
27,
27,
27,

2001
2001
2001
2001

80MG
120MG
160MG
240MG
80MG
120MG
160MG
240MG
80MG
80MG
120MG
120MG
160MG
160MG
240MG
240MG
80MG
120MG
160MG
240MG
80MG
120MG
160MG
240MG
80MG
120MG
160MG
240MG

A076140
A076140
A076140
A076140
A075663
A075663
A075663
A075663
A075237
A075725
A075237
A075725
A075237
A075725
A075237
A075725
A075366
A075366
A075366
A075366
A075429
A075429
A075429
A075429
A075563
A075563
A075563
A075563

001
002
003
004
001
002
003
004
001
001
002
002
003
003
004
004
001
002
003
004
001
002
003
004
001
002
003
004

Sep
Sep
Sep
Sep
Nov
Nov
Nov
Nov
May
Dec
May
Dec
May
Dec
May
Dec
May
May
May
May
May
May
May
May
Nov
Nov
Nov
Nov

26,
26,
26,
26,
07,
07,
07,
07,
01,
19,
01,
19,
01,
19,
01,
19,
01,
01,
01,
01,
01,
01,
01,
01,
07,
07,
07,
07,

2002
2002
2002
2002
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2003
2003
2003
2003

80MG
120MG
160MG

N021151 001
N021151 002
N021151 003

Feb 22, 2000

Feb 22, 2000
Feb 22, 2000

80MG
120MG
160MG
80MG

A077070
A077070
A077070
A076214

Nov
Nov
Nov
Aug

001
002
003
001

04,
04,
04,
27,

2005
2005
2005
2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 379 (of 424)

SOTALOL HYDROCHLORIDE
TABLET; ORAL
SOTALOL HYDROCHLORIDE
APOTEX
AB2
AB2
MYLAN
AB2
AB2
AB2
TEVA
AB2
AB2
AB2

002
003
001
002
003
001
002
003

Aug
Aug
Feb
Feb
Feb
Jul
Jul
Jul

27,
27,
07,
07,
07,
26,
26,
26,

2003
2003
2007
2007
2007
2004
2004
2004

120MG
160MG
80MG
120MG
160MG
80MG
120MG
160MG

A076214
A076214
A077616
A077616
A077616
A076883
A076883
A076883

10%

N017643 001

20%
20%

N018449 001
N020248 001

Aug 07, 1996

30%

N019942 001

Dec 30, 1993

10%

N018969 001

Sep 24, 1984

20%

N018970 001

Sep 25, 1984

30%

N020181 001

Jan 13, 1998

10%

N019531 001

May 28, 1993

20%

N019531 002

May 28, 1993

0.9%

N022408 001

Jan 18, 2011

25MG
50MG
100MG

N012151 009
N012151 008
N012151 010

Dec 30, 1983

Dec 30, 1982
Dec 30, 1983

25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
25MG
50MG
100MG

A040353
A040353
A040353
A091426
A091426
A091426
A089424
A089424
A089424
A040424
A040424
A040424
A086809
A040750
A040750
A040750

Mar
Jul
Jul
Jun
Jun
Jun
Jul
Aug
Aug
Aug
Aug
Aug

SOYBEAN OIL

AP
AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
INTRALIPID 10%
+ FRESENIUS
INTRALIPID 20%
+ FRESENIUS
+
INTRALIPID 30%
+ FRESENIUS
LIPOSYN III 10%
+ HOSPIRA
LIPOSYN III 20%
+ HOSPIRA
LIPOSYN III 30%
+ HOSPIRA
NUTRILIPID 10%
+ B BRAUN
NUTRILIPID 20%
+ B BRAUN

SPINOSAD
SUSPENSION; TOPICAL

NATROBA

XX + PARAPRO PHARMS

SPIRONOLACTONE
TABLET; ORAL
ALDACTONE
GD SEARLE LLC
AB
AB
AB +
SPIRONOLACTONE
ACTAVIS ELIZABETH
AB
AB
AB
AMNEAL PHARMS
AB
AB
AB
MUTUAL PHARM
AB
AB
AB
MYLAN
AB
AB
AB
SANDOZ
AB
VINTAGE
AB
AB
AB

003
001
002
001
002
003
001
002
003
001
002
003
001
001
002
003

15,
29,
29,
08,
08,
08,
23,
11,
11,
20,
20,
20,

2006
1999
1999
2010
2010
2010
1986
1999
1999
2001
2001
2001

Aug 29, 2006

Aug 29, 2006
Aug 29, 2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 380 (of 424)

STAVUDINE
CAPSULE; ORAL
STAVUDINE
AUROBINDO PHARMA
AB
AB
AB
AB
HETERO DRUGS
AB
AB
AB
AB
MATRIX LABS LTD
AB
AB
MYLAN
AB
AB
AB
AB
ZERIT
BRISTOL MYERS SQUIBB
AB
AB
AB
AB +
FOR SOLUTION; ORAL
STAVUDINE
AUROBINDO PHARMA
AA
CIPLA LTD
AA
ZERIT
AA + BRISTOL MYERS SQUIBB

15MG
20MG
30MG
40MG
15MG
20MG
30MG
40MG
30MG
40MG
15MG
20MG
30MG
40MG

A077672
A077672
A077672
A077672
A078957
A078957
A078957
A078957
A078775
A078775
A079069
A079069
A079069
A079069

003
004
001
002
001
002
003
004
001
002
001
002
003
004

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Jan
Jan
Dec
Dec
Dec
Dec

29,
29,
29,
29,
29,
29,
29,
29,
05,
05,
29,
29,
29,
29,

2008
2008
2008
2008
2008
2008
2008
2008
2009
2009
2008
2008
2008
2008

15MG
20MG
30MG
40MG

N020412
N020412
N020412
N020412

002
003
004
005

Jun
Jun
Jun
Jun

24,
24,
24,
24,

1994
1994
1994
1994

1MG/ML
1MG/ML

A077774 001
A078030 001

Dec 29, 2008

Mar 20, 2009

1MG/ML

N020413 001

Sep 06, 1996

N018802 001

Oct 27, 1982

A088400
N019633
N018632
N018632
N018233
N018801
N019869
A077393

Jan
Feb
Apr
Jun

STERILE WATER FOR INJECTION

AP
AP
AP
AP
AP
AP
AP
AP
AP

LIQUID; N/A
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
+ HOSPIRA
100%
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
APP PHARMS
100%
+ B BRAUN
100%
+ BAXTER HLTHCARE
100%
+
100%
+ HOSPIRA
100%
+
100%
+
100%
TARO PHARMS IRELAND
100%

001
001
002
001
001
001
001
001

16,
29,
19,
30,

1984
1988
1988
1982

Oct 27, 1982

Dec 26, 1989
Aug 11, 2006

STERILE WATER FOR IRRIGATION

AT
AT
AT
AT
AT

LIQUID; IRRIGATION
STERILE WATER
BAXTER HLTHCARE
100%
STERILE WATER IN PLASTIC CONTAINER
B BRAUN
100%
BAXTER HLTHCARE
100%
HOSPIRA
100%
100%

N017428 001
N016734
N017866
N017513
N018313

001
001
001
001

STREPTOMYCIN SULFATE
INJECTABLE; INJECTION

STREPTOMYCIN SULFATE

XX + X GEN PHARMS

EQ 1GM BASE/VIAL

A064210 001

Jun 30, 1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 381 (of 424)

STREPTOZOCIN
INJECTABLE; INJECTION

ZANOSAR

XX + TEVA PARENTERAL

1GM/VIAL

N050577 001

May 07, 1982

N020134 001

Jun 18, 1993

A075941 001

Jan 06, 2003

N019998 002

Jan 30, 1991

STRONTIUM CHLORIDE SR-89

INJECTABLE; INJECTION
METASTRON
AP + GE HEALTHCARE
1mCi/ML
STRONTIUM CHLORIDE SR-89
BIO NUCLEONICS
AP
1mCi/ML

SUCCIMER
CAPSULE; ORAL

CHEMET

XX + LUNDBECK INC

100MG

SUCCINYLCHOLINE CHLORIDE

AP
AP
AP
XX

INJECTABLE; INJECTION
ANECTINE
+ SANDOZ
20MG/ML
QUELICIN
+ HOSPIRA
20MG/ML
QUELICIN PRESERVATIVE FREE
+ HOSPIRA
20MG/ML
QUELICIN PRESERVATIVE FREE
+ HOSPIRA
100MG/ML

N008453 002
N008845 006
N008845 001
N008845 004

SUCRALFATE
SUSPENSION; ORAL

CARAFATE

XX + APTALIS PHARMA US
TABLET; ORAL
CARAFATE
AB + APTALIS PHARMA US
SUCRALFATE
NOSTRUM LABS
AB
TEVA
AB

1GM/10ML

N019183 001

Dec 16, 1993

1GM

N018333 001

1GM
1GM

A074415 001
A070848 001

Jun 08, 1998

Mar 29, 1996

N019050 001

May 04, 1984

A074413 001
A074534 001

Dec 15, 1995

Dec 11, 1996

SUFENTANIL CITRATE
INJECTABLE; INJECTION
SUFENTA PRESERVATIVE FREE
AP + AKORN
EQ 0.05MG BASE/ML
SUFENTANIL CITRATE
BAXTER HLTHCARE
AP
EQ 0.05MG BASE/ML
HOSPIRA
AP
EQ 0.05MG BASE/ML

SULCONAZOLE NITRATE
CREAM; TOPICAL

EXELDERM

XX + RANBAXY

1%

N018737 001

Feb 28, 1989

SOLUTION; TOPICAL

EXELDERM

XX + RANBAXY

1%

N018738 001

Aug 30, 1985

10%

N019931 001

Dec 23, 1996

SULFACETAMIDE SODIUM
LOTION; TOPICAL
KLARON
AB + SANOFI AVENTIS US

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 382 (of 424)

SULFACETAMIDE SODIUM
LOTION; TOPICAL
SULFACETAMIDE SODIUM
ALTANA
AB
PERRIGO CO TENNESSEE
AB
TARO
AB
OINTMENT; OPHTHALMIC
CETAMIDE
AT + ALCON
SULFACETAMIDE SODIUM
FERA PHARMS
AT

10%
10%
10%

A077015 001
A078649 001
A078668 001

10%

A080021 001

10%

A080029 001

SOLUTION/DROPS; OPHTHALMIC
BLEPH-10
AT + ALLERGAN
10%
SULFACETAMIDE SODIUM
ALCON UNIVERSAL
AT
10%
BAUSCH AND LOMB
AT
10%

Nov 17, 2006

Mar 23, 2009
May 20, 2009

A080028 001
A089560 001
A040066 001

Oct 18, 1988

Dec 28, 1994

A040091 001

Jul 29, 1994

A073303 001

Oct 31, 1991

A091348 001
A074650 001
A077785 001

Jun 08, 2010

Dec 29, 1997
Jan 24, 2007

N018615 001

Jan 07, 1983

SULFADIAZINE
TABLET; ORAL

SULFADIAZINE

XX + SANDOZ

500MG

SULFAMETHOXAZOLE; TRIMETHOPRIM
INJECTABLE; INJECTION

SULFAMETHOXAZOLE AND TRIMETHOPRIM

80MG/ML;16MG/ML
XX + TEVA PARENTERAL

AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

SUSPENSION; ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM
AUROBINDO PHARMA
200MG/5ML;40MG/5ML
+ HI TECH PHARMA
200MG/5ML;40MG/5ML
VINTAGE
200MG/5ML;40MG/5ML
SULFATRIM PEDIATRIC
ACTAVIS MID ATLANTIC 200MG/5ML;40MG/5ML
TABLET; ORAL
BACTRIM
MUTUAL PHARM
400MG;80MG
BACTRIM DS
+ MUTUAL PHARM
800MG;160MG
SEPTRA
MONARCH PHARMS
400MG;80MG
SEPTRA DS
MONARCH PHARMS
800MG;160MG
SULFAMETHOPRIM
NOVEL LABS INC
400MG;80MG
SULFAMETHOPRIM-DS
NOVEL LABS INC
800MG;160MG
SULFAMETHOXAZOLE AND TRIMETHOPRIM
AMNEAL PHARMS NY
400MG;80MG
800MG;160MG
AUROBINDO PHARMA
400MG;80MG
800MG;160MG
GLENMARK GENERICS
400MG;80MG
800MG;160MG
MUTUAL PHARM
800MG;160MG
VINTAGE
400MG;80MG
800MG;160MG
VISTA PHARMS
400MG;80MG
800MG;160MG

N017377 001
N017377 002
N017376 001
N017376 002
A070022 001

Feb 15, 1985

A070032 001

Feb 15, 1985

A076899
A076899
A090624
A090624
A090828
A090828
A071017
A078060
A078060
A076817
A076817

Jan
Jan
Feb
Feb
Dec
Dec
Aug
Jan
Jan
Oct
Oct

001
002
001
002
002
001
001
002
001
001
002

27,
27,
16,
16,
22,
22,
25,
25,
25,
07,
07,

2005
2005
2010
2010
2010
2010
1986
2007
2007
2005
2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 383 (of 424)

SULFAMETHOXAZOLE; TRIMETHOPRIM
TABLET; ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
SANDOZ
AB
800MG;160MG
TEVA
AB
800MG;160MG
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH
PLANTEX
AB
400MG;80MG

N018598 004
A070037 001

May 19, 1982

Jun 02, 1987

A070030 001

Jun 02, 1987

15%

N006530 003

Jan 27, 1987

250MG/5ML

A086983 001

500MG

N007073 001

500MG
500MG
500MG

A040349 001
A085828 001
A087197 001

Jan 11, 2002

TABLET, DELAYED RELEASE; ORAL

AZULFIDINE EN-TABS
AB + PHARMACIA AND UPJOHN 500MG
SULFASALAZINE
VINTAGE PHARMS
AB
500MG

N007073 002

Apr 06, 1983

A075339 001

Jan 11, 2002

SULFANILAMIDE
CREAM; VAGINAL

AVC

XX + AZUR PHARMA

SULFASALAZINE
SUSPENSION; ORAL

AZULFIDINE

XX + PHARMACIA AND UPJOHN

TABLET; ORAL
AZULFIDINE
AB + PHARMACIA AND UPJOHN
SULFASALAZINE
VINTAGE PHARMS
AB
WATSON LABS
AB
AB

SULINDAC
TABLET; ORAL
CLINORIL
AB + MERCK
SULINDAC
EPIC PHARMA
AB
AB
MUTUAL PHARM
AB
AB
MYLAN
AB
AB
WATSON LABS
AB
AB

200MG

N017911 002

150MG
200MG
150MG
200MG
150MG
200MG
150MG
200MG

A072710
A072711
A072050
A072051
A073039
A073039
A071891
A071795

5MG/SPRAY
20MG/SPRAY

N020626 001
N020626 003

Aug 26, 1997

Aug 26, 1997

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N020080 003

Dec 23, 1996

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

A090358 001

Jun 21, 2011

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N020080 001

Dec 28, 1992

001
001
001
001
002
001
001
001

Mar
Mar
Apr
Apr
Jun
Jun
Apr
Apr

25,
25,
17,
17,
22,
22,
03,
03,

1991
1991
1991
1991
1993
1993
1990
1990

SUMATRIPTAN
SPRAY; NASAL

IMITREX

XX + GLAXOSMITHKLINE
XX +

SUMATRIPTAN SUCCINATE
INJECTABLE; SUBCUTANEOUS
IMITREX STATDOSE
AB + GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE
SUN PHARM INDS INC
AB
IMITREX
AP + GLAXOSMITHKLINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 384 (of 424)

SUMATRIPTAN SUCCINATE
INJECTABLE; SUBCUTANEOUS
SUMATRIPTAN SUCCINATE
APP PHARMS
AP
AP
AP
BEDFORD
AP
BEDFORD LABS
AP
JHP PHARMS
AP
PAR PHARM
AP
SAGENT STRIDES
AP
AP
SANDOZ
AP
AP
TEVA PARENTERAL
AP
WOCKHARDT
AP
ALSUMA
XX + MERIDIAN MEDCL
IMITREX STATDOSE
XX + GLAXOSMITHKLINE
SUMAVEL DOSEPRO
XX + ZOGENIX INC
TABLET; ORAL
IMITREX
GLAXOSMITHKLINE
AB
AB
AB +
SUMATRIPTAN SUCCINATE
AUROBINDO PHARMA
AB
AB
AB
DR REDDYS LABS INC
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
ORCHID HLTHCARE
AB
AB
AB
RANBAXY
AB
AB
AB
SANDOZ
AB
AB
AB
SUN PHARM INDS
AB
AB
AB
TEVA
AB
AB
AB
WATSON LABS
AB
AB
AB

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

6MG
6MG
4MG
6MG
6MG
6MG
6MG
6MG
6MG
4MG
6MG
6MG
6MG

BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML
BASE/0.5ML

(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ
(EQ

12MG BASE/ML)
12MG BASE/ML)
8MG BASE/ML)
12MG BASE/ML)
12MG BASE/ML)
12MG BASE/ML)
12MG BASE/ML)
12MG BASE/ML)
12MG BASE/ML)
8MG BASE/ML)
12MG BASE/ML)
12MG BASE/ML)
12MG BASE/ML)

A079242
A079240
A079240
A079123
A090310
A077871
A077332
A090314
A090641
A078067
A078067
A077907
A078593

001
002
001
001
001
001
001
001
001
002
001
001
001

Mar
Sep
Sep
Feb
Aug
Jul
Oct
Jun
Jul
Feb
Feb
Feb
Feb

02,
18,
18,
06,
11,
09,
09,
10,
28,
06,
06,
06,
06,

2009
2009
2009
2009
2010
2009
2009
2010
2010
2009
2009
2009
2009

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N022377 001

Jun 29, 2010

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

N020080 002

Feb 01, 2006

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

N022239 001

Jul 15, 2009

EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE

N020132 002
N020132 003
N020132 001

Jun 01, 1995

Jun 01, 1995
Jun 01, 1995

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A078327
A078327
A078327
A076847
A076847
A076847
A077163
A077744
A077163
A077744
A077163
A077744
A078284
A078284
A078284
A076554
A076554
A076572
A076976
A076976
A076976
A078295
A078295
A078295
A076840
A076840
A076840
A076933
A076933
A076933

Aug
Aug
Aug
Aug
Aug
Aug
Nov
Aug
Nov
Aug
Nov
Aug
Aug
Aug
Aug
Aug
Aug
Feb
Aug
Aug
Aug
Aug
Aug
Aug
Feb
Feb
Feb
Aug
Aug
Aug

25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
25MG BASE
50MG BASE
50MG BASE
100MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE

001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
001
001
002
003
001
002
003
001
002
003
001
002
003

10,
10,
10,
10,
10,
10,
02,
10,
02,
10,
02,
10,
10,
10,
10,
10,
10,
09,
10,
10,
10,
10,
10,
10,
09,
09,
09,
10,
10,
10,

2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 385 (of 424)

SUNITINIB MALATE
CAPSULE; ORAL
SUTENT
CPPI CV
XX
XX
XX
XX +

EQ
EQ
EQ
EQ

12.5MG BASE
25MG BASE
37.5MG BASE
50MG BASE

N021938
N021938
N021938
N021938

001
002
004
003

Jan
Jan
Mar
Jan

26,
26,
31,
26,

2006
2006
2009
2006

TACROLIMUS
CAPSULE; ORAL
PROGRAF
ASTELLAS
AB
AB
AB +
TACROLIMUS
ACCORD HLTHCARE
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
MYLAN
AB
AB
AB
SANDOZ
AB
AB
AB
WATSON LABS
AB

EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE

N050708 003
N050708 001
N050708 002

Aug 24, 1998

Apr 08, 1994
Apr 08, 1994

0.5MG
1MG
5MG
EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE
EQ 5MG BASE

A091195
A091195
A091195
A090509
A090509
A090509
A090596
A090596
A090596
A065461
A065461
A065461
A090402

Aug
Aug
Aug
May
May
May
Sep
Sep
Sep
Aug
Aug
Aug
Jul

INJECTABLE; INJECTION

PROGRAF

XX + ASTELLAS

EQ 5MG BASE/ML

N050709 001

Apr 08, 1994

OINTMENT; TOPICAL
PROTOPIC
ASTELLAS
XX
XX +

0.03%
0.1%

N050777 001
N050777 002

Dec 08, 2000

Dec 08, 2000

20MG

N022332 001

May 22, 2009

2.5MG
5MG
10MG
20MG

N021368
N021368
N021368
N021368

Jan
Nov
Nov
Nov

001
002
003
001
002
003
001
002
003
001
002
003
001

31,
31,
31,
12,
12,
12,
17,
17,
17,
10,
10,
10,
01,

2011
2011
2011
2010
2010
2010
2010
2010
2010
2009
2009
2009
2010

TADALAFIL
TABLET; ORAL

ADCIRCA

XX + ELI LILLY CO
CIALIS
LILLY
XX
XX
XX
XX +

004
001
002
003

07,
21,
21,
21,

2008
2003
2003
2003

TALC
AEROSOL, METERED; INTRAPLEURAL

SCLEROSOL

400MG/SPRAY
XX + BRYAN

N020587 001

Dec 24, 1997

POWDER; INTRAPLEURAL

TALC

XX + BRYAN

5GM/BOT

N021388 001

Dec 15, 2003

EQ 10MG BASE
EQ 20MG BASE

A076398 001
A076398 002

Mar 31, 2003

Mar 31, 2003

TAMOXIFEN CITRATE
TABLET; ORAL
TAMOXIFEN CITRATE
AEGIS PHARMS
AB
AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 386 (of 424)

TAMOXIFEN CITRATE
TABLET; ORAL
TAMOXIFEN CITRATE
APOTEX
AB
AB
MYLAN
AB
AB
TEVA
AB
AB + TEVA PHARMS
WATSON LABS
AB
AB
WATSON LABS FLORIDA
AB
AB

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A090878
A090878
A074732
A074732
A075797
A074858
A070929
A070929
A076179
A076179

001
002
002
001
001
001
001
002
001
002

Sep
Sep
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb

23,
23,
20,
20,
20,
20,
20,
20,
20,
20,

2011
2011
2003
2003
2003
2003
2003
2003
2003
2003

TAMSULOSIN HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
FLOMAX
+ BOEHRINGER INGELHEIM 0.4MG
TAMSULOSIN HYDROCHLORIDE
IMPAX LABS
0.4MG
MYLAN
0.4MG
SANDOZ
0.4MG
SUN PHARM INDS LTD
0.4MG
SYNTHON PHARMS
0.4MG
TEVA PHARMS
0.4MG
WOCKHARDT
0.4MG
ZYDUS PHARMS USA INC 0.4MG

N020579 001

Apr 15, 1997

A090377
A090408
A078015
A090931
A078801
A077630
A078938
A078225

Mar
Apr
Apr
Jul
Apr
Apr
Apr
Apr

001
001
001
001
001
001
001
001

02,
27,
27,
15,
27,
27,
27,
27,

2010
2010
2010
2010
2010
2010
2010
2010

TAPENTADOL HYDROCHLORIDE
TABLET; ORAL
NUCYNTA
JANSSEN PHARMS
XX
XX
XX +

EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE

TABLET, EXTENDED RELEASE; ORAL

NUCYNTA ER
JANSSEN PHARMS
EQ 50MG BASE
XX
EQ 100MG BASE
XX
EQ 150MG BASE
XX
EQ 200MG BASE
XX
EQ 250MG BASE
XX +

N022304 001
N022304 002
N022304 003

Nov 20, 2008

Nov 20, 2008
Nov 20, 2008

N200533
N200533
N200533
N200533
N200533

Aug
Aug
Aug
Aug
Aug

001
002
003
004
005

25,
25,
25,
25,
25,

2011
2011
2011
2011
2011

TAZAROTENE
CREAM; TOPICAL

AVAGE

XX + ALLERGAN
TAZORAC
XX + ALLERGAN
XX +

0.1%

N021184 003

Sep 30, 2002

0.05%
0.1%

N021184 001
N021184 002

Sep 29, 2000

Sep 29, 2000

GEL; TOPICAL

TAZORAC

XX + ALLERGAN
XX +

0.05%
0.1%

N020600 001
N020600 002

Jun 13, 1997

Jun 13, 1997

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

INJECTABLE; INJECTION
PULMOLITE
BS
PHARMALUCENCE

N/A

N017776 001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 387 (of 424)

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

INJECTABLE; INJECTION
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT
BS
DRAXIMAGE
N/A

N017881 001

Dec 30, 1987

N020256 001

Nov 23, 1994

N018467 001

Mar 16, 1982

N019829 001

Dec 30, 1988

N018963 001

Jan 21, 1987

A078242 001

Jan 29, 2008

N018035 002

Feb 27, 2004

TECHNETIUM TC-99M BICISATE KIT

INJECTABLE; INJECTION
NEUROLITE
LANTHEUS MEDCL
XX

N/A

TECHNETIUM TC-99M DISOFENIN KIT

INJECTABLE; INJECTION
HEPATOLITE
PHARMALUCENCE
XX

N/A

TECHNETIUM TC-99M EXAMETAZIME KIT

INJECTABLE; INJECTION

CERETEC

XX + GE HEALTHCARE

N/A

TECHNETIUM TC-99M MEBROFENIN KIT

INJECTABLE; INJECTION
CHOLETEC
AP + BRACCO
N/A
TECHNETIUM TC-99M MEBROFENIN
PHARMALUCENCE
AP
N/A

TECHNETIUM TC-99M MEDRONATE

INJECTABLE; INJECTION

DRAXIMAGE MDP-25

XX + DRAXIMAGE

N/A

TECHNETIUM TC-99M MEDRONATE KIT

INJECTABLE; INJECTION
CIS-MDP
PHARMALUCENCE
AP
MDP-BRACCO
BRACCO
AP

N/A

N018124 001

N/A

N018107 001

TECHNETIUM TC-99M MERTIATIDE KIT

INJECTABLE; INJECTION

TECHNESCAN MAG3

XX + MALLINCKRODT

N/A

N019882 001

Jun 15, 1990

TECHNETIUM TC-99M OXIDRONATE KIT

INJECTABLE; INJECTION

TECHNESCAN

XX + MALLINCKRODT

N/A

N018321 001

TECHNETIUM TC-99M PENTETATE KIT

INJECTABLE; INJECTION
AN-DTPA
PHARMALUCENCE
AP
DTPA
DRAXIMAGE
AP

N/A

N017714 001

N/A

N018511 001

Dec 29, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 388 (of 424)

TECHNETIUM TC-99M PYROPHOSPHATE KIT

INJECTABLE; INJECTION
CIS-PYRO
PHARMALUCENCE
AP
TECHNESCAN PYP KIT
MALLINCKRODT
AP

N/A

N019039 001

N/A

N017538 001

Jun 30, 1987

TECHNETIUM TC-99M RED BLOOD CELL KIT

INJECTABLE; INJECTION
ULTRATAG
MALLINCKRODT
XX

N/A

N019981 001

Jun 10, 1991

N019785 001

Dec 21, 1990

A078809 001
A078806 001
A079157 001

Apr 28, 2009

Apr 29, 2009
Jul 10, 2009

A078098 001

Sep 22, 2008

TECHNETIUM TC-99M SESTAMIBI KIT

AP
AP
AP
AP
AP

INJECTABLE; INJECTION
CARDIOLITE
+ LANTHEUS MEDCL
N/A
TECHNETIUM TC 99M SESTAMIBI
CARDINAL HEALTH 414
N/A
DRAXIMAGE
N/A
PHARMALUCENCE
10-30mCi
TECHNETIUM TC-99 SESTAMIBI
MALLINCKRODT
N/A

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

SOLUTION; INJECTION, ORAL

TECHNELITE

0.0083-2.7 CI/GENERATOR
XX + LANTHEUS MEDCL
ULTRA-TECHNEKOW FM

0.25-3 CI/GENERATOR
XX + MALLINCKRODT

N017771 001

N017243 002

TECHNETIUM TC-99M SUCCIMER KIT

INJECTABLE; INJECTION

MPI DMSA KIDNEY REAGENT

XX
GE HEALTHCARE
N/A

N017944 001

May 18, 1982

TECHNETIUM TC-99M SULFUR COLLOID KIT

SOLUTION; INJECTION, ORAL

AN-SULFUR COLLOID

N/A
XX + PHARMALUCENCE

N017858 001

TECHNETIUM TC-99M TETROFOSMIN KIT

INJECTABLE; INJECTION

MYOVIEW

XX + GE HEALTHCARE
MYOVIEW 30ML
XX + GE HEALTHCARE

N/A

N020372 001

Feb 09, 1996

N/A

N020372 002

Jul 07, 2005

375MG

N201917 001

May 23, 2011

EQ 250MG BASE/VIAL
EQ 750MG BASE/VIAL

N022110 001
N022110 002

Sep 11, 2009

Sep 11, 2009

TELAPREVIR
TABLET; ORAL

INCIVEK

XX + VERTEX PHARMS

TELAVANCIN HYDROCHLORIDE
POWDER; IV (INFUSION)
VIBATIV
THERAVANCE INC
XX
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 389 (of 424)

TELBIVUDINE
TABLET; ORAL

TYZEKA

XX + NOVARTIS

600MG

N022011 001

Oct 25, 2006

300MG
400MG

N021144 002
N021144 001

Feb 09, 2005

Apr 01, 2004

20MG
40MG
80MG

N020850 003
N020850 001
N020850 002

Apr 04, 2000

Nov 10, 1998
Nov 10, 1998

7.5MG
15MG
22.5MG
30MG

N018163
N018163
N018163
N018163

003
001
004
002

Oct 25, 1991

15MG
30MG
7.5MG
22.5MG
7.5MG
15MG
22.5MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG

A071638
A071620
A078581
A071175
A070920
A070920
A070920
A070920
A071456
A071457
A071427
A071428
A071446
A071447

001
001
001
002
002
004
003
001
001
001
001
001
001
001

Aug
Aug
Sep
Sep
May
Jul
Jun
Jul
Apr
Apr
Jan
Jan
May
May

07,
07,
08,
14,
21,
07,
12,
10,
21,
21,
12,
12,
21,
21,

1987
1987
2009
2009
2010
1986
2009
1986
1987
1987
1988
1988
1993
1993

5MG
20MG
100MG
140MG
180MG
250MG

N021029
N021029
N021029
N021029
N021029
N021029

001
002
003
005
006
004

Aug
Aug
Aug
Oct
Oct
Aug

11,
11,
11,
19,
19,
11,

1999
1999
1999
2006
2006
1999

5MG
20MG
100MG
140MG
180MG
250MG

A078879
A078879
A078879
A078879
A078879
A078879

001
002
003
005
006
004

Mar
Mar
Mar
Mar
Mar
Mar

01,
01,
01,
01,
01,
01,

2010
2010
2010
2010
2010
2010

TELITHROMYCIN
TABLET; ORAL
KETEK
SANOFI AVENTIS US
XX
XX +

TELMISARTAN
TABLET; ORAL
MICARDIS
XX
BOEHRINGER INGELHEIM
XX
XX +

TEMAZEPAM
CAPSULE; ORAL
RESTORIL
MALLINCKRODT INC
AB
AB
AB
AB +
TEMAZEPAM
ACTAVIS ELIZABETH
AB
AB
MUTUAL PHARM
AB
AB
MYLAN
AB
AB
AB
AB
NOVEL LABS INC
AB
AB
SANDOZ
AB
AB
WATSON LABS
AB
AB

Nov 02, 2004

TEMOZOLOMIDE
CAPSULE; ORAL
TEMODAR
SCHERING
AB
AB
AB
AB
AB
AB +
TEMOZOLOMIDE
BARR
AB
AB
AB
AB
AB
AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 390 (of 424)

TEMOZOLOMIDE
POWDER; INTRAVENOUS

TEMODAR

XX + SCHERING

100MG/VIAL

N022277 001

Feb 27, 2009

25MG/ML (25MG/ML)

N022088 001

May 30, 2007

10MG/ML

N020119 001

Jul 14, 1992

300MG

N021356 001

Oct 26, 2001

TEMSIROLIMUS
SOLUTION; INTRAVENOUS

TORISEL

XX + WYETH PHARMS INC

TENIPOSIDE
INJECTABLE; INJECTION

VUMON

XX + BRISTOL MYERS SQUIBB

TENOFOVIR DISOPROXIL FUMARATE

TABLET; ORAL

VIREAD

XX + GILEAD

TERAZOSIN HYDROCHLORIDE
CAPSULE; ORAL
HYTRIN
ABBOTT
AB
AB +
AB
AB
TERAZOSIN HYDROCHLORIDE
APOTEX
AB
AB
AB
AB
IVAX SUB TEVA PHARMS
AB
AB
AB
AB
JUBILANT CADISTA
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
RANBAXY
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB

EQ
EQ
EQ
EQ

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

N020347
N020347
N020347
N020347

001
002
003
004

Dec
Dec
Dec
Dec

14,
14,
14,
14,

1994
1994
1994
1994

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

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

A075498
A075498
A075498
A075498
A075614
A075614
A075614
A075614
A075317
A075317
A075317
A075317
A075140
A075140
A075140
A075140
A076021
A076021
A076021
A076021
A074823
A074823
A074823
A074823

001
002
003
004
002
001
003
004
001
002
003
004
002
003
001
004
001
002
003
004
001
002
003
004

Apr
Apr
Apr
Apr
Jan
Jan
Jan
Jan
Dec
Dec
Dec
Dec
Feb
Feb
Feb
Feb
Aug
Aug
Aug
Aug
Mar
Mar
Mar
Mar

12,
12,
12,
12,
30,
30,
30,
30,
20,
20,
20,
20,
11,
11,
11,
11,
22,
22,
22,
22,
30,
30,
30,
30,

2001
2001
2001
2001
2001
2001
2001
2001
2004
2004
2004
2004
2000
2000
2000
2000
2002
2002
2002
2002
1998
1998
1998
1998

TABLET; ORAL
HYTRIN
ABBOTT
XX
XX +
XX
XX

EQ
EQ
EQ
EQ

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

N019057
N019057
N019057
N019057

001
002
003
004

Aug
Aug
Aug
Aug

07,
07,
07,
07,

1987
1987
1987
1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 391 (of 424)

TERBINAFINE HYDROCHLORIDE
GRANULE; ORAL
LAMISIL
NOVARTIS
XX
XX +

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

EQ 125MG BASE/PACKET
EQ 187.5MG BASE/PACKET

N022071 001
N022071 002

Sep 28, 2007

Sep 28, 2007

250MG BASE

N020539 001

May 10, 1996

250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG

A078199
A078297
A077714
A076390
A078157
A077919
A077533
A077136
A077195
A078163
A076377
A077137
A078229

001
001
001
001
001
001
001
001
001
001
001
001
001

Jul
Jul
Jun
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

02,
02,
04,
02,
02,
02,
02,
02,
02,
02,
02,
02,
02,

2007
2007
2010
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007

1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML

A078151
A076887
A076770
A078630
A076853

001
001
001
001
001

Jan
May
Apr
May
Jul

07,
26,
23,
20,
20,

2008
2004
2004
2009
2004

2.5MG
5MG
2.5MG
5MG

A075877
A075877
A077152
A077152

001
002
001
002

Jun
Jun
Mar
Mar

26,
26,
25,
25,

2001
2001
2005
2005

0.8%

N019964 001

Feb 21, 1991

0.4%

N019579 001

Dec 31, 1987

0.4%
0.4%
0.8%

A076712 001
A076043 001
A075953 001

Feb 18, 2005

Jan 19, 2005
Apr 06, 2004

0.8%

N021735 001

Oct 01, 2004

80MG

N019641 001

May 24, 1988

80MG
80MG
80MG

A076850 001
A077149 001
A077553 001

Jul 12, 2006

Mar 17, 2006
Mar 09, 2007

TABLET; ORAL
LAMISIL
+ NOVARTIS
EQ
TERBINAFINE HYDROCHLORIDE
APOTEX
EQ
AUROBINDO PHARMA
EQ
BRECKENRIDGE PHARM
EQ
DR REDDYS LABS INC
EQ
GLENMARK GENERICS
EQ
HARRIS PHARM
EQ
INVAGEN PHARMS
EQ
MYLAN
EQ
EQ
ORCHID HLTHCARE
EQ
TEVA
EQ
WATSON LABS
EQ
WOCKHARDT
EQ

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

TERBUTALINE SULFATE

AP
AP
AP
AP
AP

INJECTABLE; INJECTION
TERBUTALINE SULFATE
AKORN
APP PHARMS
+ BEDFORD
HIKMA FARMACEUTICA
TEVA PARENTERAL

TABLET; ORAL
TERBUTALINE SULFATE
IMPAX LABS
AB
AB +
LANNETT
AB
AB

TERCONAZOLE

AB
AB
AB
AB
AB
BX

AB
AB
AB
AB

CREAM; VAGINAL
TERAZOL 3
+ JANSSEN PHARMS
TERAZOL 7
+ JANSSEN PHARMS
TERCONAZOLE
ALTANA
TARO
TERCONAZOLE
+ NYCOMED US
SUPPOSITORY; VAGINAL
TERAZOL 3
+ JANSSEN PHARMS
TERCONAZOLE
ALTANA
PERRIGO NEW YORK
TARO

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 392 (of 424)

TERIPARATIDE RECOMBINANT HUMAN

INJECTABLE; SUBCUTANEOUS

FORTEO

XX + LILLY

0.6MG/2.4ML (0.25MG/ML)

N021318 002

Jun 25, 2008

EQ 1MG BASE/VIAL

N022505 001

Nov 10, 2010

N020489 003
N020489 004

Oct 20, 2011

Oct 20, 2011

1% (5GM/PACKET)

N021015 002

Feb 28, 2000

1% (5GM/PACKET)

N021454 001

Oct 31, 2002

1% (2.5GM/PACKET)

N021015 001

Feb 28, 2000

N021015 003
N022309 001

Sep 26, 2003

Apr 29, 2011

N021463 001

Dec 29, 2010

TESAMORELIN ACETATE
POWDER; SUBCUTANEOUS

EGRIFTA

XX + THERATECHNOLOGIES

TESTOSTERONE
FILM, EXTENDED RELEASE; TRANSDERMAL

ANDRODERM

XX + WATSON LABS

2MG/24HR
XX +

4MG/24HR
GEL; TRANSDERMAL
ANDROGEL
BX + ABBOTT LABS
TESTIM
BX + AUXILIUM PHARMS
ANDROGEL
ABBOTT LABS
XX

GEL, METERED; TRANSDERMAL

ANDROGEL

1% (1.25GM/ACTIVATION)
XX + ABBOTT LABS
1.62% (20.25MG/1.25GM ACTIVATION)
XX +

FORTESTA

10MG/0.5GM ACTIVATION
XX + ENDO PHARMS
PELLET; IMPLANTATION

TESTOPEL

XX + SLATE PHARMS

75MG

A080911 001

SOLUTION, METERED; TRANSDERMAL

AXIRON

30MG/1.5ML ACTIVATION
XX + ELI LILLY AND CO

N022504 001

Nov 23, 2010

TABLET, EXTENDED RELEASE; BUCCAL

STRIANT

30MG
XX + ACTIENT PHARMS

N021543 001

Jun 19, 2003

TESTOSTERONE CYPIONATE
INJECTABLE; INJECTION
DEPO-TESTOSTERONE
AO + PHARMACIA AND UPJOHN
AO +
TESTOSTERONE CYPIONATE
BEDFORD
AO
AO
PADDOCK LLC
AO
SANDOZ
AO
AO
SYNERX PHARMA
AO
WATSON LABS
AO

100MG/ML
200MG/ML

A085635 002
A085635 003

100MG/ML
200MG/ML
200MG/ML
100MG/ML
200MG/ML
200MG/ML
200MG/ML

A090387
A090387
A040530
A040615
A040615
A040652
A086030

200MG/ML

N009165 003

200MG/ML
200MG/ML

A040575 001
A040647 001

001
002
001
001
002
001
001

Jul
Jul
Jan
Aug
Aug
Dec

15,
15,
31,
10,
10,
11,

2010
2010
2005
2006
2006
2006

TESTOSTERONE ENANTHATE
INJECTABLE; INJECTION
DELATESTRYL
AO + ENDO PHARM
TESTOSTERONE ENANTHATE
PADDOCK LLC
AO
SYNERX PHARMA
AO

Jun 14, 2006

Oct 05, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 393 (of 424)

TESTOSTERONE ENANTHATE
INJECTABLE; INJECTION
TESTOSTERONE ENANTHATE
WATSON LABS
AO

200MG/ML

A085598 001

12.5MG
25MG

N021894 001
N021894 002

TETRABENAZINE
TABLET; ORAL
XENAZINE
VALEANT INTL
XX
XX +

Aug 15, 2008

Aug 15, 2008

TETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL
TETRACYCLINE HYDROCHLORIDE
IMPAX LABS
AB
250MG
AB
500MG
IVAX SUB TEVA PHARMS 250MG
AB
AB +
500MG
WATSON LABS
AB
250MG
AB
500MG
TETRACYCLINE HYDROCHLORIDE

IMPAX LABS
100MG
XX

A060469
A060469
A060704
A060704
A061837
A061837

001
003
001
002
001
002

A060469 002

TETRAHYDROZOLINE HYDROCHLORIDE
SOLUTION; NASAL

TYZINE

XX + NYCOMED US
XX

0.05%
0.1%

A086576 002

A086576 001

SPRAY; NASAL

TYZINE

XX + NYCOMED US

0.1%

A086576 003

50MG
100MG
150MG
200MG

N020785
N020785
N020785
N020785

THALIDOMIDE
CAPSULE; ORAL
THALOMID
CELGENE
XX
XX
XX
XX +

001
002
004
003

Jul
Jan
Jan
Jan

16,
17,
10,
17,

1998
2003
2007
2003

THALLOUS CHLORIDE TL-201

INJECTABLE; INJECTION
THALLOUS CHLORIDE TL 201
AP + GE HEALTHCARE
1mCi/ML
AP + LANTHEUS MEDCL
1mCi/ML
AP + MALLINCKRODT
1mCi/ML

N018110 002
N017806 001
N018150 001

Feb 27, 1996

INJECTABLE; INTRAVENOUS
THALLOUS CHLORIDE TL 201
AP + LANTHEUS MEDCL
2mCi/ML
MALLINCKRODT
AP
2mCi/ML

N017806 002
A077698 001

Oct 09, 1998

Nov 09, 2006

A087942 001
A087943 001
A087944 001

Aug 22, 1983

Aug 22, 1983
Aug 22, 1983

A040052 001

Feb 14, 1994

THEOPHYLLINE
CAPSULE, EXTENDED RELEASE; ORAL
THEO-24
BC
UCB INC
100MG
BC
200MG
BC
300MG
THEOPHYLLINE
BC
INWOOD LABS
100MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 394 (of 424)

THEOPHYLLINE

BC
BC
XX
XX

CAPSULE, EXTENDED RELEASE; ORAL

THEOPHYLLINE
INWOOD LABS
200MG
+
300MG
THEO-24
UCB INC
400MG
THEOPHYLLINE
INWOOD LABS
125MG

ELIXIR; ORAL

ELIXOPHYLLIN

XX + CARACO

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP

80MG/15ML

INJECTABLE; INJECTION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
+ B BRAUN
40MG/100ML
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
+ B BRAUN
80MG/100ML
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER
+ B BRAUN
160MG/100ML
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER
+ B BRAUN
320MG/100ML
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
4MG/ML
+
40MG/100ML
+
80MG/100ML
+
160MG/100ML
+
200MG/100ML
+
320MG/100ML
+
400MG/100ML
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER
+ HOSPIRA INC
4MG/ML
+
40MG/100ML
+
160MG/100ML
+
320MG/100ML

A040052 003
A040052 004

Feb 14, 1994

Feb 14, 1994

A081034 001

Feb 28, 1992

A040052 002

Feb 14, 1994

A085186 001

N019826 001

Aug 14, 1992

N019826 002

Aug 14, 1992

N019826 003

Aug 14, 1992

N019826 006

Aug 14, 1992

N018649
N018649
N018649
N018649
N018649
N018649
N018649

007
001
002
003
004
006
005

Jul
Jul
Jul
Jul
Jul
Nov
Jul

26,
26,
26,
26,
26,
13,
26,

1982
1982
1982
1982
1982
1985
1982

N019211
N019211
N019211
N019211

007
001
003
006

Dec
Dec
Dec
Jan

14,
14,
14,
20,

1984
1984
1984
1988

SOLUTION; ORAL

THEOPHYLLINE

XX + SILARX

80MG/15ML

A091156 001

TABLET; ORAL

THEOLAIR

XX + GRACEWAY
XX +

125MG
250MG

A086399 001
A086399 002

TABLET, EXTENDED RELEASE; ORAL

THEOCHRON
CARACO
AB
100MG
AB
200MG
AB
300MG
THEOPHYLLINE
ALEMBIC LTD
AB
300MG
AB
450MG
GLENMARK GENERICS
AB
400MG
AB
600MG
INWOOD LABS
AB
450MG
NOSTRUM
AB
400MG
AB +
600MG
AB + PLIVA
100MG
AB +
200MG
AB
300MG
AB +
450MG

Apr 13, 2011

A088320 001
A088321 001
A087400 002

Feb 21, 1985

Feb 21, 1985
Jan 11, 1983

A090430
A090430
A090355
A090355
A040034
A040595
A040560
A089807
A089808
A089763
A081236

Oct
Oct
Jul
Jul
Apr
Apr
Apr
Apr
Apr
Apr
Nov

001
002
001
002
001
001
002
001
001
001
001

27,
27,
13,
13,
28,
21,
21,
30,
30,
30,
09,

2010
2010
2010
2010
1995
2006
2006
1990
1990
1990
1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 395 (of 424)

THIAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
THIAMINE HYDROCHLORIDE
AP + APP PHARMS
WATSON LABS
AP
THIAMINE HYDROCHLORIDE
XX + WATSON LABS

100MG/ML
100MG/ML

A080556 001
A080571 001

200MG/ML

A080571 002

40MG

N012429 001

THIOGUANINE
TABLET; ORAL

THIOGUANINE

XX + GLAXOSMITHKLINE

THIORIDAZINE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
THIORIDAZINE HYDROCHLORIDE
MUTUAL PHARM
10MG
25MG
50MG
100MG
MYLAN
10MG
25MG
50MG
+
100MG

A089953
A089953
A089953
A089953
A088004
A088004
A088004
A088004

004
003
002
001
002
003
004
001

Aug
Aug
Aug
Oct
Mar
Mar
Mar
Nov

01,
01,
01,
07,
15,
15,
15,
18,

1986
1986
1986
1988
1983
1983
1983
1983

THIOTEPA
INJECTABLE; INJECTION
THIOTEPA
XX
BEDFORD

15MG/VIAL

A075547 001

Apr 02, 2001

1MG
2MG
5MG
10MG

N016584
N016584
N016584
N016584

001
002
003
004

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

A071093
A071093
A071093
A071093
A071610
A071570
A071529
A071530
A070601
A070602

002
003
004
001
001
001
001
001
001
001

1.1MG/VIAL

N020898 001

Nov 30, 1998

2MG
4MG

N020646 005
N020646 001

Apr 16, 1999

Sep 30, 1997

THIOTHIXENE
CAPSULE; ORAL
NAVANE
PFIZER
AB
AB
AB +
AB
THIOTHIXENE
MYLAN
AB
AB
AB
AB
SANDOZ
AB
AB
AB
AB
WATSON LABS
AB
AB

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

23,
23,
23,
23,
24,
24,
24,
24,
05,
05,

1987
1987
1987
1987
1987
1987
1987
1987
1987
1987

THYROTROPIN ALFA
INJECTABLE; INJECTION

THYROGEN

XX + GENZYME

TIAGABINE HYDROCHLORIDE
TABLET; ORAL
GABITRIL
CEPHALON
AB
AB +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 396 (of 424)

TIAGABINE HYDROCHLORIDE
TABLET; ORAL
TIAGABINE HYDROCHLORIDE
SUN PHARM INDS
AB
2MG
AB
4MG
GABITRIL
CEPHALON
6MG
XX
8MG
XX
10MG
XX
12MG
XX
16MG
XX

A077555 001
A077555 002

Nov 04, 2011

Nov 04, 2011

N020646
N020646
N020646
N020646
N020646

Nov
Nov
Nov
Sep
Sep

006
007
008
002
003

29,
29,
29,
30,
30,

2005
2005
2005
1997
1997

TICAGRELOR
TABLET; ORAL

BRILINTA

XX + ASTRAZENECA LP

90MG

N022433 001

Jul 20, 2011

A075089
A075526
A075161
A075326
A075149

Jul
Sep
Sep
Aug
Aug

TICLOPIDINE HYDROCHLORIDE

AB
AB
AB
AB
AB

TABLET; ORAL
TICLOPIDINE HYDROCHLORIDE
APOTEX
250MG
CARACO
250MG
MYLAN
250MG
SANDOZ
250MG
+ TEVA
250MG

001
001
001
001
001

01,
26,
13,
20,
20,

1999
2002
1999
1999
1999

TIGECYCLINE
INJECTABLE; IV (INFUSION)

TYGACIL

50MG/VIAL
XX + WYETH PHARMS INC

N021821 001

Jun 15, 2005

EQ 200MG BASE

N020707 001

Mar 07, 1997

SOLUTION/DROPS; OPHTHALMIC

BETIMOL

XX + SANTEN OY
EQ 0.25% BASE
XX +
EQ 0.5% BASE

N020439 001
N020439 002

Mar 31, 1995

Mar 31, 1995

0.25% BASE
0.5% BASE

N020963 001
N020963 002

Oct 21, 1998

Oct 21, 1998

0.25% BASE
0.5% BASE

N020330 001
N020330 002

Nov 04, 1993

Nov 04, 1993

0.25% BASE
0.5% BASE
0.5% BASE
0.25% BASE
0.5% BASE
0.25% BASE
0.5% BASE

A074515
A074466
A074516
A075411
A075412
A074778
A074776

Mar
Mar
Mar
Sep
Sep
Mar
Mar

TILUDRONATE DISODIUM
TABLET; ORAL

SKELID

XX + SANOFI AVENTIS US

TIMOLOL

TIMOLOL MALEATE

AB
AB

SOLUTION, GEL FORMING/DROPS;

TIMOLOL MALEATE
FALCON PHARMS
EQ
EQ
TIMOPTIC-XE
+ ATON
EQ
+
EQ

AT
AT
AT
AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
TIMOLOL MALEATE
AKORN
EQ
EQ
EQ
APOTEX INC
EQ
EQ
BAUSCH AND LOMB
EQ
EQ

AB
AB

OPHTHALMIC

001
001
001
001
001
001
001

25,
25,
25,
08,
08,
25,
25,

1997
1997
1997
2000
2000
1997
1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 397 (of 424)

TIMOLOL MALEATE

AT
AT
AT
AT
AT
AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
TIMOLOL MALEATE
FALCON PHARMS
EQ
EQ
FDC LTD
EQ
EQ
HI TECH PHARMA
EQ
PACIFIC PHARMA
EQ
EQ
WOCKHARDT
EQ
EQ
TIMOPTIC
+ ATON
EQ
+
EQ
ISTALOL
+ ISTA PHARMS
EQ
TIMOPTIC IN OCUDOSE
+ ATON
EQ
+
EQ

28,
28,
30,
30,
10,
25,
25,
28,
28,

1995
1995
2008
2008
2002
1997
1997
2009
2009

A074261
A074262
A077259
A077259
A075163
A074746
A074747
A078771
A078771

0.25% BASE
0.5% BASE

N018086 001
N018086 002

0.5% BASE

N021516 001

Jun 04, 2004

0.25% BASE
0.5% BASE

N019463 001
N019463 002

Nov 05, 1986

Nov 05, 1986

5MG
10MG
20MG

A072668 002
A072668 003
A072668 001

Jun 08, 1990

Jun 08, 1990
Jun 08, 1990

250MG
500MG

N021618 001
N021618 002

May 17, 2004

May 17, 2004

20,000 IU/ML

N020484 001

Jul 14, 2000

100MG

N019569 001

Aug 11, 1988

EQ 0.018MG BASE/INH

N021395 001

Jan 30, 2004

CAPSULE; ORAL

APTIVUS

XX + BOEHRINGER INGELHEIM

250MG

N021814 001

Jun 22, 2005

SOLUTION; ORAL

APTIVUS

XX + BOEHRINGER INGELHEIM

100MG/ML

N022292 001

Jun 23, 2008

EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)

N020913 002

May 17, 2002

AT
AT
BT
XX
XX

TABLET; ORAL
TIMOLOL MALEATE
MYLAN
XX
XX
XX +

001
001
001
002
001
001
001
001
002

Apr
Apr
Apr
Apr
Sep
Mar
Mar
Sep
Sep

0.25% BASE
0.5% BASE
0.25% BASE
0.5% BASE
0.5% BASE
0.25% BASE
0.5% BASE
0.25% BASE
0.5% BASE

TINIDAZOLE
TABLET; ORAL
TINDAMAX
MISSION PHARMA
XX
XX +

TINZAPARIN SODIUM
INJECTABLE; INJECTION

INNOHEP

XX + LEO PHARMA AS

TIOPRONIN
TABLET; ORAL

TIOPRONIN

XX + MISSION PHARMA

TIOTROPIUM BROMIDE MONOHYDRATE

POWDER; INHALATION

SPIRIVA

XX + BOEHRINGER INGELHEIM

TIPRANAVIR

TIROFIBAN HYDROCHLORIDE
INJECTABLE; INJECTION
AGGRASTAT
MEDICURE
XX

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 398 (of 424)

TIROFIBAN HYDROCHLORIDE
INJECTABLE; INJECTION

AGGRASTAT

XX + MEDICURE

EQ 12.5MG BASE/250ML (EQ 0.05MG

BASE/ML)

N020913 003

Apr 20, 2000

EQ 2MG BASE
EQ 4MG BASE
EQ 6MG BASE

N021447 001
N021447 002
N021447 003

Aug 29, 2002

Aug 29, 2002
Aug 29, 2002

A076282
A076282
A076533
A076533
A076416
A076416
A076347
A076347
A076286
A076286
A076354
A076354
A076399
A076280
A076284
A076284

Dec
Dec
Jan
Jan
Sep
Sep
Oct
Oct
Jul
Jul
Mar
Mar
Nov
Jun
Jul
Jul

TIZANIDINE HYDROCHLORIDE
CAPSULE; ORAL

ZANAFLEX

XX
ACORDA

XX
XX +

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
TIZANIDINE HYDROCHLORIDE
ALPHAPHARM
EQ
EQ
APOTEX
EQ
EQ
CARACO
EQ
EQ
COREPHARMA
EQ
EQ
DR REDDYS LABS INC
EQ
EQ
MYLAN
EQ
EQ
SANDOZ
EQ
EQ
TEVA
EQ
EQ
ZANAFLEX
EQ
+ ACORDA

2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

4MG BASE

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

N020397 001

16,
16,
16,
16,
29,
29,
11,
11,
03,
03,
28,
28,
26,
27,
03,
03,

2003
2003
2004
2004
2003
2003
2002
2002
2002
2002
2003
2003
2002
2002
2002
2002

Nov 27, 1996

TOBRAMYCIN
OINTMENT; OPHTHALMIC

TOBREX

XX + ALCON

0.3%

N050555 001

SOLUTION; INHALATION

TOBI

XX + NOVARTIS PHARMS

300MG/5ML

N050753 001

Dec 22, 1997

A064096 001

Jan 31, 1996

A064052 001
A065026 001
A065087 001

Nov 29, 1993

Sep 11, 2001
Feb 25, 2002

A062535 001
N050541 001

Dec 13, 1984

A065407
A064021
A065122
A065122
N050789

Mar
May
Nov
Nov
Jul

AT
AT
AT
AT
AT
AT

SOLUTION/DROPS; OPHTHALMIC
AKTOB
AKORN
0.3%
TOBRAMYCIN
BAUSCH AND LOMB
0.3%
FERA PHARMS
0.3%
NOVEX
0.3%
TOBREX
ALCON
0.3%
0.3%
+ FALCON PHARMS

TOBRAMYCIN SULFATE

AP
AP
AP
AP
AP

INJECTABLE; INJECTION
TOBRAMYCIN SULFATE
AKORN STRIDES
APOTHECON
APP PHARMS
+

EQ
EQ
EQ
EQ
EQ

40MG BASE/ML
10MG BASE/ML
10MG BASE/ML
40MG BASE/ML
1.2GM BASE/VIAL

001
001
001
002
001

11,
31,
29,
29,
13,

2008
1994
2002
2002
2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 399 (of 424)

TOBRAMYCIN SULFATE
INJECTABLE; INJECTION
TOBRAMYCIN SULFATE
BAXTER HLTHCARE
AP
EQ 40MG BASE/ML
AP + HOSPIRA
EQ 10MG BASE/ML
AP
EQ 40MG BASE/ML
AP +
EQ 40MG BASE/ML
MARSAM PHARMS LLC
AP
EQ 10MG BASE/ML
TEVA PARENTERAL
AP
EQ 40MG BASE/ML
AP + X GEN PHARMS
EQ 1.2GM BASE/VIAL
TOBRAMYCIN SULFATE (PHARMACY BULK)
APP PHARMS
AP
EQ 40MG BASE/ML
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
EQ 1.2MG BASE/ML
XX + HOSPIRA
EQ 1.6MG BASE/ML
XX +
EQ 80MG BASE/100ML
XX +

A063117
A063112
A063111
A063116
A062945
A063100
A065013

001
001
001
001
001
001
001

Apr
Apr
Apr
May
Aug
Jan
Aug

26,
30,
30,
18,
09,
30,
17,

1991
1991
1991
1992
1989
1992
2001

A065120 001

Nov 29, 2002

A063081 003
A063081 006
A063081 001

Jul 31, 1990

Jun 02, 1993
Jul 31, 1990

250MG
500MG
250MG
500MG

A070259
A070259
A070514
A070515

Jan
Mar
Jan
Jan

500MG
500MG
500MG

A086445 001
A086109 001
A087318 001

100MG

N020697 001

Jan 29, 1998

CAPSULE; ORAL
TOLMETIN SODIUM
MYLAN
AB
AB + TEVA

EQ 400MG BASE
EQ 400MG BASE

A073393 001
A073290 001

May 27, 1993

Nov 27, 1991

TABLET; ORAL
TOLMETIN SODIUM
MUTUAL PHARM
AB
AB + MYLAN

EQ 200MG BASE
EQ 600MG BASE

A073310 001
A074473 001

Nov 27, 1991

Aug 30, 1994

CAPSULE, EXTENDED RELEASE; ORAL

DETROL LA
XX
PHARMACIA AND UPJOHN 2MG
XX +
4MG

N021228 001
N021228 002

Dec 22, 2000

Dec 22, 2000

TABLET; ORAL
DETROL
XX
PHARMACIA AND UPJOHN
XX +

N020771 001
N020771 002

Mar 25, 1998

Mar 25, 1998

TOLAZAMIDE
TABLET; ORAL
TOLAZAMIDE
MYLAN
AB
AB +
WATSON LABS
AB
AB

001
003
001
001

02,
17,
09,
09,

1986
1986
1986
1986

TOLBUTAMIDE
TABLET; ORAL
TOLBUTAMIDE
MYLAN
AB
AB + WATSON LABS
AB

TOLCAPONE
TABLET; ORAL

TASMAR

XX + VALEANT PHARM INTL

TOLMETIN SODIUM

TOLTERODINE TARTRATE

1MG
2MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 400 (of 424)

TOLVAPTAN
TABLET; ORAL
SAMSCA
OTSUKA AMERICA PHARM
XX
XX +

15MG
30MG

N022275 001
N022275 002

May 19, 2009

May 19, 2009

15MG
25MG

N020844 001
N020844 002

Oct 26, 1998

Oct 26, 1998

15MG
25MG
15MG
25MG
15MG
25MG
15MG
25MG
15MG
25MG

A078418
A078418
A079206
A079206
A076575
A076575
A077868
A077868
A078877
A078877

001
002
001
002
001
002
001
002
001
002

Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Oct
Oct

14,
14,
14,
14,
17,
17,
15,
15,
14,
14,

2009
2009
2009
2009
2009
2009
2009
2009
2009
2009

25MG
50MG
100MG
200MG

N020505
N020505
N020505
N020505

004
005
001
002

Dec
Dec
Dec
Dec

24,
24,
24,
24,

1996
1996
1996
1996

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
100MG
200MG

A076311
A076311
A076311
A076311
A077733
A077733
A077733
A077733
A078462
A078462
A078462
A078462
A076343
A076343
A076343
A076343
A077627
A077627
A077627
A077627
A079162
A079162
A079162
A079162
A076314
A076314
A076314
A076314
A076327
A076327
A076327

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,

2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009

TOPIRAMATE
CAPSULE; ORAL
TOPAMAX
JANSSEN PHARMS
AB
AB +
TOPIRAMATE
MYLAN
AB
AB
SANDOZ
AB
AB
TEVA
AB
AB
WATSON LABS
AB
AB
ZYDUS PHARMS USA INC
AB
AB
TABLET; ORAL
TOPAMAX
AB + JANSSEN PHARMS
AB
AB
AB
TOPIRAMATE
ACCORD HLTHCARE
AB
AB
AB
AB
APOTEX INC
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
CIPLA LTD
AB
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
RANBAXY
AB
AB
AB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 401 (of 424)

TOPIRAMATE
TABLET; ORAL
TOPIRAMATE
SUN PHARM INDS LTD
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
TORRENT PHARMS
AB
AB
AB
AB
UNICHEM
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
AB

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Jan
Jan
Jan
Jan
Mar
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Mar

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
07,
07,
07,
07,
27,
27,
27,
27,
01,
01,
01,
01,
27,
27,
27,
27,

2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2010
2010
2010
2010
2009
2009
2009
2009
2010
2010
2010
2010
2009
2009
2009
2009

25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG

A090278
A090278
A090278
A090278
A076317
A076317
A076317
A076317
A079153
A079153
A079153
A079153
A090162
A090162
A090162
A078499
A078499
A078499
A078499
A077643
A077643
A077643
A077643
A090353
A090353
A090353
A090353
A078235
A078235
A078235
A078235

EQ 0.25MG BASE
EQ 1MG BASE

N020981 001
N020981 002

Oct 11, 2007

Oct 11, 2007

EQ 4MG BASE/VIAL

N020671 001

May 28, 1996

EQ
EQ
EQ
EQ
EQ
EQ

A090620
A091089
A201191
A091376
A091284
A091199

Dec
Nov
Mar
Nov
Jan
Dec

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

TOPOTECAN HYDROCHLORIDE
CAPSULE; ORAL
HYCAMTIN
SMITHKLINE BEECHAM
XX
XX +

AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
HYCAMTIN
+ GLAXOSMITHKLINE
TOPOTECAN HYDROCHLORIDE
ACTAVIS TOTOWA
APP PHARMS
DR REDDYS LABS LTD
FRESENIUS KABI ONCOL
SAGENT PHARMS
THREE RIVERS PHARMS

SOLUTION; INTRAVENOUS

TOPOTECAN

XX + HOSPIRA INC

4MG
4MG
4MG
4MG
4MG
4MG

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

001
001
001
001
001
001

02,
29,
09,
29,
26,
01,

2010
2010
2011
2010
2011
2010

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

N200582 001

Feb 02, 2011

EQ 60MG BASE

N020497 001

May 29, 1997

TOREMIFENE CITRATE
TABLET; ORAL

FARESTON

XX + GTX INC

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 402 (of 424)

TORSEMIDE
INJECTABLE; INJECTION
TORSEMIDE
AP + BEDFORD LABS
AP +
LUITPOLD
AP
AP

A078007
A078007
A090656
A090656

001
002
002
001

Jun
Jun
Apr
Apr

11,
11,
21,
21,

2008
2008
2010
2010

5MG
10MG
20MG
100MG

N020136
N020136
N020136
N020136

001
002
003
004

Aug
Aug
Aug
Aug

23,
23,
23,
23,

1993
1993
1993
1993

5MG
10MG
20MG
100MG
5MG
10MG
20MG
100MG
5MG
10MG
20MG
100MG
5MG
10MG
20MG
100MG
5MG
10MG
20MG
100MG
5MG
10MG
20MG
5MG
10MG
20MG
100MG
5MG
10MG
20MG
100MG
5MG
10MG
20MG
100MG

A076894
A076894
A076894
A076894
A078249
A078249
A078249
A078249
A079234
A079234
A079234
A079234
A076226
A076226
A076226
A076226
A076346
A076346
A076346
A076346
A076943
A076943
A076943
A078478
A078478
A078478
A078478
A076110
A076110
A076110
A076110
A090613
A090613
A090613
A090613

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
001
002
003
004
001
002
003
004
001
002
003
004

May
May
May
May
Oct
Oct
Oct
Oct
Jan
Jan
Jan
Jan
May
May
May
May
May
May
May
Oct
Mar
Mar
Mar
Feb
Feb
Feb
Feb
May
May
May
May
Mar
Mar
Mar
Mar

31,
31,
31,
31,
17,
17,
17,
17,
27,
27,
27,
27,
27,
27,
27,
27,
30,
30,
30,
19,
01,
01,
01,
26,
26,
26,
26,
14,
14,
14,
14,
22,
22,
22,
22,

2005
2005
2005
2005
2007
2007
2007
2007
2009
2009
2009
2009
2003
2003
2003
2003
2003
2003
2003
2004
2005
2005
2005
2008
2008
2008
2008
2002
2002
2002
2002
2011
2011
2011
2011

CAPSULE, EXTENDED RELEASE; ORAL

CONZIP

100MG
XX + CIPHER PHARMS INC
150MG
XX
200MG
XX
300MG
XX

N022370
N022370
N022370
N022370

001
004
002
003

May
Aug
May
May

07,
01,
07,
07,

2010
2011
2010
2010

TABLET; ORAL
TRAMADOL HYDROCHLORIDE
ALPHAPHARM
AB

A075980 001

TABLET; ORAL
DEMADEX
MEDA PHARMS
AB
AB
AB +
AB
TORSEMIDE
APOTEX INC
AB
AB
AB
AB
AUROBINDO PHARMA
AB
AB
AB
AB
HETERO DRUGS
AB
AB
AB
AB
PAR PHARM
AB
AB
AB
AB
PLIVA PHARM IND
AB
AB
AB
AB
ROXANE
AB
AB
AB
SUN PHARM INDS
AB
AB
AB
AB
TEVA
AB
AB
AB
AB
VINTAGE PHARMS
AB
AB
AB
AB

20MG/2ML
50MG/5ML
50MG/5ML
20MG/2ML

(10MG/ML)
(10MG/ML)
(10MG/ML)
(10MG/ML)

TRAMADOL HYDROCHLORIDE

50MG

Nov 21, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 403 (of 424)

TRAMADOL HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
TRAMADOL HYDROCHLORIDE
ALVOGEN
AMNEAL PHARMS
APOTEX
CARACO
MALLINCKRODT
MUTUAL PHARM
MYLAN
NORTHSTAR HLTHCARE
PLIVA
SANDOZ
TEVA
WATSON LABS
ZYDUS PHARMS USA INC
ULTRAM
+ JANSSEN PHARMS

TABLET, EXTENDED RELEASE;

TRAMADOL HYDROCHLORIDE
LUPIN LTD
AB1
AB1
AB1
PAR PHARM
AB1
AB1
AB1
SUN PHARMA GLOBAL
AB1
AB1
AB1
ULTRAM ER
AB1 + VALEANT INTL
AB1
AB1
RYZOLT
AB2 + PURDUE PHARMA
AB2
AB2
TRAMADOL HYDROCHLORIDE
SUN PHARMA GLOBAL
AB2
AB2
AB2

001
001
001
001
001
001
001
001
001
001
001
001
001

Nov
Jun
Jul
Jun
Jun
Jun
Jun
May
Jul
Jun
Jun
Jun
Jan

28,
20,
10,
19,
25,
20,
21,
26,
01,
25,
19,
24,
31,

2011
2002
2002
2002
2002
2002
2002
2010
2002
2002
2002
2002
2011

50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG

A202075
A076003
A075981
A075964
A075983
A076100
A075986
A078935
A075982
A075968
A075977
A075962
A090404

50MG

N020281 002

Mar 03, 1995

100MG
200MG
300MG
100MG
200MG
300MG
100MG
200MG
300MG

A200503
A200503
A200503
A078783
A078783
A078783
A201384
A201384
A201384

Aug
Aug
Aug
Nov
Nov
Sep
Dec
Dec
Dec

100MG
200MG
300MG

N021692 001
N021692 002
N021692 003

Sep 08, 2005

Sep 08, 2005
Sep 08, 2005

100MG
200MG
300MG

N021745 001
N021745 002
N021745 003

Dec 30, 2008

Dec 30, 2008
Dec 30, 2008

100MG
200MG
300MG

A091607 001
A091607 002
A091607 003

Dec 30, 2011

Dec 30, 2011
Dec 30, 2011

N021693 001

May 05, 2005

1MG
2MG
4MG

N020528 001
N020528 002
N020528 003

Apr 26, 1996

Apr 26, 1996
Apr 26, 1996

1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG

A078438
A078438
A078438
A077307
A077307
A077307
A077256
A077256

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

ORAL

TABLET, ORALLY DISINTEGRATING; ORAL

TRAMADOL HYDROCHLORIDE

50MG
XX + SHIONOGI INC

001
002
003
001
002
003
001
002
003

29,
29,
29,
13,
13,
20,
07,
07,
07,

2011
2011
2011
2009
2009
2011
2011
2011
2011

TRANDOLAPRIL
TABLET; ORAL
MAVIK
ABBOTT
AB
AB
AB +
TRANDOLAPRIL
AUROBINDO PHARMA
AB
AB
AB
CIPLA
AB
AB
AB
COREPHARMA
AB
AB

001
002
003
002
001
003
001
002

12,
12,
12,
12,
12,
12,
12,
12,

2007
2007
2007
2007
2007
2007
2007
2007

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 404 (of 424)

TRANDOLAPRIL
TABLET; ORAL
TRANDOLAPRIL
COREPHARMA
AB
DR REDDYS LABS LTD
AB
AB
AB
EPIC PHARMA
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
LUPIN
AB
AB
AB
MYLAN
AB
AB
AB
TEVA PHARMS
AB
AB
AB
WATSON LABS
AB
AB
AB

4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG
1MG
2MG
4MG

A077256
A078493
A078493
A078493
A078508
A078508
A078508
A078320
A078320
A078320
A077522
A077522
A077522
A078346
A078346
A078346
A077489
A077489
A077489
A077805
A077805
A077805

003
001
002
003
003
001
002
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jun
Aug
Aug
Aug
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Apr
Apr
Apr
Dec
Dec
Dec
Jun
Jun
Jun

12,
25,
25,
25,
18,
18,
18,
12,
12,
12,
12,
12,
12,
28,
28,
28,
12,
12,
12,
12,
12,
12,

2007
2008
2008
2008
2008
2008
2008
2007
2007
2007
2007
2007
2007
2008
2008
2008
2006
2006
2006
2007
2007
2007

N020591
N020591
N020591
N020591

003
001
004
002

Oct
Oct
Oct
Oct

22,
22,
22,
22,

1996
1996
1996
1996

A079135
A079135
A079135
A079135

004
001
002
003

Aug
May
May
May

30,
26,
26,
05,

2010
2010
2010
2010

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL
TARKA
ABBOTT
AB
1MG;240MG
AB
2MG;180MG
AB
2MG;240MG
AB +
4MG;240MG
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
GLENMARK GENERICS
AB
1MG;240MG
AB
2MG;180MG
AB
2MG;240MG
AB
4MG;240MG

TRANEXAMIC ACID

AP
AP
AP
AP

INJECTABLE; INJECTION
CYKLOKAPRON
+ PHARMACIA AND UPJOHN
TRANEXAMIC ACID
MYLAN INSTITUTIONAL
PHARMAFORCE
VERSAPHARM INC

TABLET; ORAL

LYSTEDA

XX + FERRING PHARMS AS

100MG/ML

N019281 001

Dec 30, 1986

100MG/ML
100MG/ML
100MG/ML

A091657 001
A201885 001
A202373 001

Nov 03, 2011

Aug 10, 2011
Nov 17, 2011

650MG

N022430 001

Nov 13, 2009

N012342 003

Aug 16, 1985

A040640 001

Jun 29, 2006

TRANYLCYPROMINE SULFATE
TABLET; ORAL
PARNATE
AB + GLAXOSMITHKLINE
EQ 10MG BASE
TRANYLCYPROMINE SULFATE
PAR PHARM
AB
EQ 10MG BASE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 405 (of 424)

TRAVOPROST
SOLUTION/DROPS; OPHTHALMIC

TRAVATAN Z

0.004%
XX + ALCON PHARMS LTD

N021994 001

Sep 21, 2006

TABLET; ORAL
TRAZODONE HYDROCHLORIDE
ALVOGEN
AB
50MG
AB
100MG
APOTEX
AB
50MG
AB + APOTEX INC
100MG
AB
150MG
AB
300MG
MATRIX LABS LTD
AB
50MG
AB
100MG
AB
150MG
AB
300MG
MUTUAL PHARM
AB
50MG
AB
100MG
AB
150MG
PLIVA
AB
50MG
AB
100MG
AB
150MG
VINTAGE
AB
50MG
AB
100MG
WATSON LABS
AB
50MG
AB
100MG

A071636
A071514
A071258
A071196
A071196
A071196
A090514
A090514
A090514
A090514
A073137
A073137
A073137
A071523
A071524
A071525
A072192
A072193
A070857
A070858

Apr
Apr
Mar
Mar
Apr
Apr
Jun
Jun
Jun
Jun
Mar
Mar
Dec
Dec
Dec
Mar
Feb
Feb
Oct
Oct

TABLET, EXTENDED RELEASE; ORAL

OLEPTRO

150MG
XX + ANGELINI LLC
300MG
XX

N022411 001
N022411 002

Feb 02, 2010

Feb 02, 2010

N021272
N021272
N021272
N021272

May
May
May
May

TRAZODONE HYDROCHLORIDE

001
001
001
001
002
003
001
002
003
004
002
001
003
001
001
001
001
001
001
001

18,
18,
25,
25,
26,
26,
02,
02,
02,
02,
24,
24,
22,
11,
11,
09,
02,
02,
10,
10,

1988
1988
1987
1987
1999
1999
2009
2009
2009
2009
1993
1993
1995
1987
1987
1988
1989
1989
1986
1986

TREPROSTINIL SODIUM

XX
XX
XX
XX

INJECTABLE; IV (INFUSION)-SC
REMODULIN
UNITED THERAP
1MG/ML
2.5MG/ML
5MG/ML
+
10MG/ML

SOLUTION; INHALATION

TYVASO

XX + UNITED THERAP

001
002
003
004

21,
21,
21,
21,

2002
2002
2002
2002

EQ 0.6MG BASE/ML

N022387 001

Jul 30, 2009

10MG

A077684 001

Jun 22, 2007

0.025%

N020404 003

Jan 14, 1997

0.025%
0.1%

N019049 001
N017340 001

Sep 16, 1988

0.025%
0.1%

A075264 001
A075213 001

Dec 24, 1998

Dec 24, 1998

0.05%

N017522 001

TRETINOIN
CAPSULE; ORAL

TRETINOIN

XX + BARR

AB
AB
AB
AB
AB

CREAM; TOPICAL
AVITA
MYLAN BERTEK
RETIN-A
+ ORTHO JANSSEN
+
TRETINOIN
TRIAX PHARMS LLC

RETIN-A
AB1 + ORTHO JANSSEN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 406 (of 424)

TRETINOIN
CREAM; TOPICAL
TRETINOIN
TRIAX PHARMS LLC
AB1
RENOVA
AB2 + ORTHO JANSSEN
TRETINOIN
SPEAR PHARMS
AB2
RENOVA
XX + ORTHO JANSSEN
TRETINOIN
XX + TRIAX PHARMS LLC
GEL; TOPICAL
RETIN-A
AB + ORTHO JANSSEN
AB +
TRETINOIN
TRIAX PHARMS LLC
AB
AB
AVITA
BT
MYLAN
ATRALIN
XX + DOW PHARM SCIENCES
RETIN-A MICRO
XX + VALEANT INTL
XX +
SOLUTION; TOPICAL
RETIN-A
AT + ORTHO JANSSEN
TRETINOIN
WOCKHARDT
AT

0.05%

A075265 001

Dec 24, 1998

0.05%

N019963 001

Dec 29, 1995

0.05%

A076498 001

Sep 15, 2005

0.02%

N021108 001

Aug 31, 2000

0.0375%

A090098 001

Mar 22, 2010

0.01%
0.025%

N017955 001
N017579 002

0.01%
0.025%

A075589 001
A075529 001

Jun 11, 2002

Feb 22, 2000

0.025%

N020400 001

Jan 29, 1998

0.05%

N022070 001

Jul 26, 2007

0.04%
0.1%

N020475 002
N020475 001

May 10, 2002

Feb 07, 1997

0.05%

N016921 001

0.05%

A075260 001

Jan 25, 1999

N018117 001

Apr 23, 1982

TRIAMCINOLONE ACETONIDE
AEROSOL, METERED; INHALATION

AZMACORT

0.1MG/INH
XX + ABBOTT
CREAM; TOPICAL
KENALOG
AT + APOTHECON
AT +
TRIACET
TEVA
AT
AT
TRIAMCINOLONE ACETONIDE
ALTANA
AT
AT
AT +
G AND W LABS
AT
PERRIGO NEW YORK
AT
AT
AT
TARO
AT
AT
AT
AT
VINTAGE
AT
AT
TRIDERM
CROWN LABS
AT

0.025%
0.1%

N011601 003
N011601 006

0.025%
0.5%

A084908 001
A084908 003

0.025%
0.1%
0.5%
0.025%
0.025%
0.1%
0.5%
0.025%
0.1%
0.1%
0.5%
0.025%
0.1%

A085692
A085692
A085692
A089797
A086415
A086414
A086413
A086277
A040039
A086276
A086275
A040671
A040671

001
003
002
001
001
001
001
001
001
001
001
001
002

Jun 09, 2006

Jun 09, 2006

0.1%

A088042 001

Mar 19, 1984

May 31, 1991

Nov 26, 1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 407 (of 424)

TRIAMCINOLONE ACETONIDE
INJECTABLE; INJECTION
KENALOG-10
APOTHECON
AB
10MG/ML
KENALOG-40
AB + APOTHECON
40MG/ML
TRIAMCINOLONE ACETONIDE
SANDOZ
AB
10MG/ML
AB
40MG/ML

A090166 001
A090164 001

May 27, 2009

May 27, 2009

INJECTABLE; INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL

TRIVARIS

8MG/0.1ML (8MG/0.1ML)
XX + ALLERGAN

N022220 001

Jun 16, 2008

INJECTABLE; INTRAVITREAL

TRIESENCE

XX + ALCON

N022048 001

Nov 29, 2007

A040467
A040467
A088450
A089129
A040672
A088451

Apr
Apr
Apr
Aug
Dec
Apr

21,
21,
01,
14,
13,
03,

2003
2003
1985
1986
2006
1985

Sep
Jun
Sep
Dec
Jun

30,
05,
30,
27,
05,

1994
2001
1994
1982
2001

40MG/ML (40MG/ML)

LOTION; TOPICAL
TRIAMCINOLONE ACETONIDE
ALTANA
AT
0.025%
AT
0.1%
MORTON GROVE
AT
0.025%
TARO
AT
0.1%
VINTAGE
AT
0.1%
AT + WOCKHARDT
0.1%
OINTMENT; TOPICAL
KENALOG
APOTHECON
AT
AT
TRIAMCINOLONE ACETONIDE
NYCOMED US
AT
AT
AT
AT + PERRIGO NEW YORK
AT +
AT +
TARO
AT
AT
AT
AT
AT
TRIAMCINOLONE ACETONIDE
XX + CAROLINA MEDCL

N012041 001
N014901 001

001
002
001
001
002
001

0.025%
0.1%

N011600 003
N011600 001

0.025%
0.1%
0.5%
0.025%
0.1%
0.5%
0.025%
0.025%
0.1%
0.1%
0.5%
IN ABSORBASE
0.05%

A085691
A085691
A085691
A087356
A087357
A087385
A040040
A040374
A040037
A087902
A040386

001
003
002
001
001
001
001
001
001
001
001

A089595 001

Mar 23, 1995

PASTE; DENTAL
TRIAMCINOLONE ACETONIDE
LYNE
AT
0.1%
AT + TARO
0.1%

A040771 001
A070730 001

Jul 01, 2010

Oct 01, 1986

SPRAY; TOPICAL

KENALOG

XX + RANBAXY

N012104 001

0.147MG/GM

SPRAY, METERED; NASAL

NASACORT AQ
AB + SANOFI AVENTIS US
0.055MG/SPRAY
TRIAMCINOLONE ACETONIDE
TEVA BRANDED PHARM
AB
0.055MG/SPRAY

N020468 001

May 20, 1996

A078104 001

Jul 30, 2009

TRIAMCINOLONE HEXACETONIDE
INJECTABLE; INJECTION

ARISTOSPAN

XX + SANDOZ
XX +

5MG/ML
20MG/ML

N016466 001
N016466 002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 408 (of 424)

TRIAMTERENE
CAPSULE; ORAL

DYRENIUM

WELLSPRING PHARM
XX
XX +

50MG
100MG

N013174 001

N013174 002

0.125MG
0.25MG

N017892 003
N017892 001

Apr 26, 1985

Nov 15, 1982

0.125MG
0.25MG
0.125MG
0.25MG
0.125MG
0.25MG

A074031
A074031
A074224
A074224
A074445
A074445

Mar
Mar
Jun
Jun
Oct
Oct

250MG

N019194 001

Nov 08, 1985

A040209
A040209
A040209
A040209
A085785
A085786
A085789
A085788

Jul
Jul
Jul
Jul

TRIAZOLAM
TABLET; ORAL
HALCION
PHARMACIA AND UPJOHN
AB
AB +
TRIAZOLAM
ALPHAPHARM
AB
AB
ROXANE
AB
AB
WATSON LABS
AB
AB

001
002
001
002
001
002

25,
25,
01,
01,
20,
20,

1994
1994
1994
1994
1995
1995

TRIENTINE HYDROCHLORIDE
CAPSULE; ORAL

SYPRINE

XX + ATON

TRIFLUOPERAZINE HYDROCHLORIDE
TABLET; ORAL
TRIFLUOPERAZINE HYDROCHLORIDE
MYLAN
AB
EQ 1MG BASE
AB
EQ 2MG BASE
AB
EQ 5MG BASE
AB +
EQ 10MG BASE
SANDOZ
AB
EQ 1MG BASE
AB
EQ 2MG BASE
AB
EQ 5MG BASE
AB
EQ 10MG BASE

001
002
003
004
001
001
001
001

07,
07,
07,
07,

1997
1997
1997
1997

TRIFLURIDINE
SOLUTION/DROPS; OPHTHALMIC
TRIFLURIDINE
ALCON
AT
1%
VIROPTIC
AT + MONARCH PHARMS
1%

A074311 001

Oct 06, 1995

N018299 001

TRIHEXYPHENIDYL HYDROCHLORIDE
ELIXIR; ORAL
TRIHEXYPHENIDYL HYDROCHLORIDE
MIKART
AA
2MG/5ML
AA + PHARM ASSOC
2MG/5ML

AA
AA
AA
AA
AA
AA
AA
AA
AA

TABLET; ORAL
TRIHEXYPHENIDYL HYDROCHLORIDE
NATCO PHARMA LTD
2MG
5MG
VINTAGE PHARMS
2MG
5MG
WATSON LABS
2MG
+
2MG
5MG
+
5MG
WEST WARD
2MG

A040251 001
A040177 001

Sep 27, 1999

Apr 17, 1997

A091630
A091630
A040254
A040254
A040184
A084363
A040184
A084364
A040337

Nov
Nov
Dec
Dec
Feb

001
002
001
002
001
001
002
001
002

17,
17,
24,
24,
06,

2010
2010
1998
1998
1998

Feb 06, 1998

Feb 16, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 409 (of 424)

TRIHEXYPHENIDYL HYDROCHLORIDE
TABLET; ORAL
TRIHEXYPHENIDYL HYDROCHLORIDE
WEST WARD
AA
5MG

A040337 001

Feb 16, 2000

TRIMETHADIONE
TABLET; ORAL

TRIDIONE

XX + ABBOTT

150MG

N005856 009

TRIMETHOBENZAMIDE HYDROCHLORIDE
CAPSULE; ORAL
TIGAN
AB + KING PHARMS
300MG
TRIMETHOBENZAMIDE HYDROCHLORIDE
GAVIS PHARMS
AB
300MG
MUTUAL PHARMA
AB
300MG

AP
AP
AP
AP

INJECTABLE; INJECTION
TIGAN
+ JHP PHARMS
100MG/ML
TRIMETHOBENZAMIDE HYDROCHLORIDE
HOSPIRA
100MG/ML
LUITPOLD
100MG/ML
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE
LUITPOLD
100MG/ML

N017531 006

Dec 13, 2001

A076546 001
A076570 001

Aug 20, 2003

Aug 28, 2003

N017530 001
A088804 001
A091330 001

Apr 03, 1987

Mar 08, 2011

A091329 001

Mar 08, 2011

100MG
100MG
100MG

A091437 001
N018679 001
A070049 001

Jun 15, 2011

Jul 30, 1982
Jun 06, 1985

200MG

A071259 001

Jun 18, 1987

EQ 50MG BASE/5ML

N074973 001

Jan 24, 2000

EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE

N016792 001
N016792 002
N016792 003

Sep 15, 1982

EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE

A077361 001
A077361 002
A077361 003

Aug 02, 2006

Aug 02, 2006
Aug 02, 2006

N020715 001
N021288 001
N022437 001

Jun 15, 2000

Jun 29, 2001
Mar 10, 2010

TRIMETHOPRIM

AB
AB
AB
XX

TABLET; ORAL
TRIMETHOPRIM
NOVEL LABS INC
TEVA
WATSON LABS
TRIMETHOPRIM
+ TEVA

TRIMETHOPRIM HYDROCHLORIDE
SOLUTION; ORAL

PRIMSOL

XX + FSC

TRIMIPRAMINE MALEATE
CAPSULE; ORAL
SURMONTIL
ODYSSEY PHARMS
AB
AB
AB +
TRIMIPRAMINE MALEATE
MIKAH PHARMA
AB
AB
AB

TRIPTORELIN PAMOATE
INJECTABLE; INTRAMUSCULAR
TRELSTAR
EQ 3.75MG BASE/VIAL
XX + WATSON LABS
EQ 11.25MG BASE/VIAL
XX +
EQ 22.5MG BASE/VIAL
XX +

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 410 (of 424)

TROMETHAMINE
INJECTABLE; INJECTION

THAM

XX + HOSPIRA

3.6GM/100ML

N013025 002

TROPICAMIDE
SOLUTION/DROPS; OPHTHALMIC
MYDRIACYL
AT + ALCON
0.5%
AT +
1%
TROPICACYL
AKORN
AT
0.5%
AT
1%
TROPICAMIDE
BAUSCH AND LOMB
AT
0.5%
AT
1%

A084305 001
A084306 001
A040314 001
A040315 001

Sep 29, 2000

Sep 29, 2000

A040067 001
A040064 001

Jul 27, 1994

Jul 27, 1994

N022103 001

Aug 03, 2007

20MG

N021595 001

May 28, 2004

20MG
20MG
20MG

A091513 001
A091575 001
A091573 001

Dec 06, 2011

Aug 13, 2010
Nov 17, 2010

0.15%

N022278 001

Feb 20, 2009

0.06%

N021670 001

Dec 16, 2004

30MG

N022474 001

Aug 13, 2010

N020586 002

May 10, 2001

1uCi

N020617 001

May 09, 1997

1uCi

N020617 002

May 09, 1997

N021289 001

May 06, 2002

TROSPIUM CHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL

SANCTURA XR

XX + ALLERGAN
60MG

AB
AB
AB
AB

TABLET; ORAL
SANCTURA
+ ALLERGAN
TROSPIUM CHLORIDE
APOTEX
GLENMARK GENERICS
PADDOCK LLC

TRYPAN BLUE
SOLUTION; OPHTHALMIC

MEMBRANEBLUE

XX + DORC
VISIONBLUE
XX + DORC

ULIPRISTAL ACETATE
TABLET; ORAL

ELLA

XX + LAB HRA PHARMA

UREA C-13
FOR SOLUTION; ORAL

BREATHTEK UBT FOR H-PYLORI

XX + OTSUKA AMERICA
EQ 75MG /POUCH

UREA, C-14
CAPSULE; ORAL

PYTEST

XX + AVENT
PYTEST KIT
XX + AVENT

UROFOLLITROPIN
INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS

BRAVELLE

75 IU/VIAL
XX + FERRING

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 411 (of 424)

URSODIOL

AB
AB
AB
AB
AB
AB

CAPSULE; ORAL
ACTIGALL
+ WATSON PHARMS
URSODIOL
COREPHARMA
EPIC PHARMA
LANNETT
MYLAN
TEVA PHARMS

TABLET; ORAL
URSO 250
APTALIS PHARMA US
AB
URSO FORTE
AB + APTALIS PHARMA US
URSODIOL
GLENMARK GENERICS
AB
AB
TEVA PHARMS
AB
AB
WATSON LABS INC
AB
AB

300MG

N019594 002

Dec 31, 1987

300MG
300MG
300MG
300MG
300MG

A077895
A075517
A079082
A090530
A075592

Jul
Mar
Dec
Feb
May

250MG

N020675 001

Dec 10, 1997

500MG

N020675 002

Jul 21, 2004

250MG
500MG
250MG
500MG
250MG
500MG

A090801
A090801
A079184
A079184
A200826
A200826

001
002
001
002
001
002

Jul
Jul
May
May
Dec
Dec

12,
12,
13,
13,
23,
23,

2011
2011
2009
2009
2011
2011

500MG BASE
1GM BASE
500MG BASE
1GM BASE
500MG BASE
1GM BASE
500MG BASE
1GM BASE
500MG BASE
1GM BASE
500MG BASE
1GM BASE
500MG BASE
1GM BASE
500MG BASE
1GM BASE
500MG BASE
1GM BASE
500MG BASE
1GM BASE
500MG BASE
1GM BASE

A090370
A090370
A090682
A090682
A079012
A079012
A078518
A078518
A078070
A078070
A076588
A076588
A078656
A078656
A077478
A077478
A077655
A077655
A077135
A077135
A090216
A090216

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

Mar
Mar
May
May
May
May
May
May
May
May
Jan
Jan
May
May
May
May
May
May
May
May
May
May

16,
16,
24,
24,
24,
24,
24,
24,
24,
24,
31,
31,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,

2011
2011
2010
2010
2010
2010
2010
2010
2010
2010
2007
2007
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010

500MG BASE
1GM BASE

N020487 001
N020487 002

Jun 23, 1995

Jun 23, 1995

001
001
001
001
001

27,
14,
15,
17,
25,

2006
2000
2008
2010
2000

VALACYCLOVIR HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
VALACYCLOVIR HYDROCHLORIDE
ACTAVIS PHARMA
EQ
EQ
AUROBINDO PHARMA
EQ
EQ
DR REDDYS LABS LTD
EQ
EQ
MATRIX LABS LTD
EQ
EQ
MYLAN
EQ
EQ
RANBAXY
EQ
EQ
ROXANE
EQ
EQ
SANDOZ
EQ
EQ
TEVA PHARMS
EQ
EQ
WATSON LABS
EQ
EQ
WOCKHARDT
EQ
EQ
VALTREX
GLAXOSMITHKLINE
EQ
+
EQ

VALGANCICLOVIR HYDROCHLORIDE
FOR SOLUTION; ORAL

VALCYTE

XX + ROCHE PALO

50MG/ML

N022257 001

Aug 28, 2009

TABLET; ORAL

VALCYTE

XX + ROCHE PALO

EQ 450MG BASE

N021304 001

Mar 29, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 412 (of 424)

VALPROATE SODIUM
INJECTABLE; INJECTION
DEPACON
+ ABBOTT
VALPROATE SODIUM
APP PHARMS
BEDFORD
HIKMA FARMACEUTICA

EQ 100MG BASE/ML

N020593 001

Dec 30, 1996

EQ 100MG BASE/ML
EQ 100MG BASE/ML
EQ 100MG BASE/ML

A076539 001
A076295 001
A078523 001

Jun 26, 2003

Nov 14, 2002
Feb 17, 2010

250MG

N018081 001

250MG
250MG

A073484 001
A073229 001

Jun 29, 1993

Oct 29, 1991

CAPSULE, DELAYED RELEASE; ORAL

STAVZOR
BANNER PHARMACAPS
125MG
XX
250MG
XX
500MG
XX +

N022152 001
N022152 002
N022152 003

Jul 29, 2008

Jul 29, 2008
Jul 29, 2008

AP
AP
AP
AP

VALPROIC ACID
CAPSULE; ORAL
DEPAKENE
AB + ABBOTT
VALPROIC ACID
BANNER PHARMACAPS
AB
CATALENT
AB

AA
AA
AA
AA
AA
AA
AA
AA

SYRUP; ORAL
DEPAKENE
+ ABBOTT
VALPROIC ACID
ALPHARMA
HIGH TECH PHARMA
PHARM ASSOC
SUN PHARM INDS INC
TEVA PHARMS
VINTAGE
WOCKHARDT

250MG/5ML

N018082 001

250MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML

A075782
A074060
A075379
A090517
A073178
A077960
A070868

001
001
001
001
001
001
001

Dec
Jan
Dec
May
Aug
Oct
Jul

22,
13,
15,
28,
25,
13,
01,

2000
1995
2000
2010
1992
2006
1986

VALRUBICIN
SOLUTION; INTRAVESICAL

VALSTAR PRESERVATIVE FREE

40MG/ML
XX + ENDO PHARM

N020892 001

Sep 25, 1998

40MG
80MG
160MG
320MG

N021283
N021283
N021283
N021283

Aug
Jul
Jul
Jul

EQ 125MG BASE
EQ 250MG BASE

N050606 001
N050606 002

Apr 15, 1986

Apr 15, 1986

A062663
A062663
A062663
A062663
A065401
A065401

Mar
Jul
Jun
Nov
Jun
Jun

VALSARTAN
TABLET; ORAL
DIOVAN
NOVARTIS
XX
XX
XX
XX +

004
001
002
003

14,
18,
18,
18,

2002
2001
2001
2001

VANCOMYCIN HYDROCHLORIDE
CAPSULE; ORAL
VANCOCIN HYDROCHLORIDE
VIROPHARMA
XX
XX +

AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
VANCOMYCIN HYDROCHLORIDE
+ APP PHARMS
EQ
+
EQ
+
EQ
+
EQ
BIONICHE PHARMA USA
EQ
EQ

500MG BASE/VIAL
1GM BASE/VIAL
5GM BASE/VIAL
10GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL

001
002
003
004
001
002

17,
31,
03,
28,
30,
30,

1987
1987
1988
1997
2008
2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 413 (of 424)

VANCOMYCIN HYDROCHLORIDE

AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
XX
XX

INJECTABLE; INJECTION
VANCOMYCIN HYDROCHLORIDE
+ HOSPIRA
EQ 500MG BASE/VIAL
+
EQ 500MG BASE/VIAL
EQ 750MG BASE/VIAL
EQ 750MG BASE/VIAL
+
EQ 1GM BASE/VIAL
+
EQ 1GM BASE/VIAL
+
EQ 5GM BASE/VIAL
HOSPIRA INC
EQ 10GM BASE/VIAL
PFIZER
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
SANDOZ
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
STRIDES ARCOLAB LTD
EQ 10GM BASE/VIAL
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
EQ 500MG BASE/100ML
+
EQ 750MG BASE/150ML

A062911
A062931
A062912
A062933
A062912
A062933
A063076
A065455
A065397
A065397
A065432
A091469
A090250
A090250
A091554

001
001
002
002
001
001
001
001
001
002
001
001
001
002
001

Aug
Oct
Jan
May
Aug
Oct
Dec
Apr
Dec
Dec
Dec
Jul
Apr
Apr
Sep

04,
29,
07,
27,
04,
29,
21,
29,
30,
30,
30,
01,
27,
27,
19,

1988
1992
2009
2009
1988
1992
1990
2009
2008
2008
2008
2011
2010
2010
2011

N050671 001
N050671 002

Apr 29, 1993

Dec 20, 2010

100MG
300MG

N022405 001
N022405 002

Apr 06, 2011

Apr 06, 2011

2.5MG
5MG
10MG
20MG

N021400
N021400
N021400
N021400

Aug
Aug
Aug
Aug

VANDETANIB
TABLET; ORAL
VANDETANIB
IPR PHARMS INC
XX
XX +

VARDENAFIL HYDROCHLORIDE
TABLET; ORAL
LEVITRA
BAYER HLTHCARE
XX
XX
XX
XX +

TABLET, ORALLY DISINTEGRATING; ORAL

STAXYN

10MG
XX + BAYER HLTHCARE

003
001
002
004

19,
19,
19,
19,

2003
2003
2003
2003

N200179 001

Jun 17, 2010

EQ 0.5MG BASE
EQ 1MG BASE

N021928 001
N021928 002

May 10, 2006

May 10, 2006

10MG/VIAL
20MG/VIAL
10MG/VIAL
20MG/VIAL
10MG/VIAL
20MG/VIAL
10MG/VIAL
20MG/VIAL
10MG/VIAL
20MG/VIAL
10MG/VIAL

A075549
A075549
A075164
A075164
A078274
A078274
A090243
A090243
A079001
A079001
A074688

Jun
Jun
Oct
Oct
Dec
Dec
May
May
Jun
Jun
Aug

VARENICLINE TARTRATE
TABLET; ORAL
CHANTIX
PFIZER INC
XX
XX +

VECURONIUM BROMIDE
INJECTABLE; INJECTION
VECURONIUM BROMIDE
AP + BEDFORD
AP +
HOSPIRA
AP
AP
MUSTAFA NEVZAT
AP
AP
PFIZER
AP
AP
SUN PHARMA GLOBAL
AP
AP
TEVA PARENTERAL
AP

001
002
001
002
001
002
001
002
001
002
001

13,
13,
21,
21,
29,
29,
11,
11,
17,
17,
25,

2000
2000
1999
1999
2008
2008
2010
2010
2009
2009
1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 414 (of 424)

VECURONIUM BROMIDE
INJECTABLE; INJECTION
VECURONIUM BROMIDE
TEVA PARENTERAL
AP
WATSON LABS
AP
AP

20MG/VIAL
10MG/VIAL
20MG/VIAL

A074688 002
A074334 001
A074334 002

Aug 25, 1999

Aug 31, 1995
Aug 31, 1995

N022575 001

Feb 26, 2010

N202429 001

Aug 17, 2011

VELAGLUCERASE ALFA
INJECTABLE; IV (INFUSION)
VPRIV
SHIRE HUMAN GENETIC
400 UNITS/VIAL
XX

VEMURAFENIB
TABLET; ORAL

ZELBORAF

XX + HOFFMANN LA ROCHE

240MG

VENLAFAXINE HYDROCHLORIDE

N020699 001
N020699 002
N020699 004

Oct 20, 1997

Oct 20, 1997
Oct 20, 1997

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

CAPSULE, EXTENDED RELEASE; ORAL

EFFEXOR XR
WYETH PHARMS INC
EQ 37.5MG BASE
EQ 75MG BASE
+
EQ 150MG BASE
VENLAFAXINE HYDROCHLORIDE
AUROBINDO PHARMA LTD EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
DR REDDYS LABS LTD
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
MYLAN
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
ORCHID HLTHCARE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
TEVA
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
TORRENT PHARMS LLC
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
VALEANT INTL
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
WOCKHARDT
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
ZYDUS PHARMS USA INC EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE

A200834
A200834
A200834
A078421
A078421
A078421
A078789
A078789
A078789
A091123
A091123
A091123
A076565
A076565
A076565
A090899
A090899
A090899
A090071
A090071
A090071
A078865
A078865
A078865
A090174
A090174
A090174

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Apr
Apr
Apr
May
May
May
Jun
Jun
Jun
Jul
Jul
Jul
Jun
Jun
Jun
Jun
Jun
Jun
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

14,
14,
14,
06,
06,
06,
01,
01,
01,
11,
11,
11,
28,
28,
28,
01,
01,
01,
15,
15,
15,
14,
14,
14,
14,
14,
14,

2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2010
2010
2010
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011

AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
VENLAFAXINE HYDROCHLORIDE
ACTAVIS TOTOWA
EQ
EQ
EQ
EQ
EQ
ALEMBIC PHARMS LTD
EQ
EQ

A078554
A078554
A078554
A078554
A078554
A078932
A078932

001
002
003
004
005
001
002

Jan
Jan
Jan
Jan
Jan
Dec
Dec

09,
09,
09,
09,
09,
14,
14,

2009
2009
2009
2009
2009
2010
2010

AB
AB
AB

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

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 415 (of 424)

VENLAFAXINE HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
XX

TABLET; ORAL
VENLAFAXINE HYDROCHLORIDE
ALEMBIC PHARMS LTD
EQ
EQ
EQ
AMNEAL PHARMS
EQ
EQ
EQ
EQ
EQ
AUROBINDO PHARMA
EQ
EQ
EQ
EQ
EQ
CARACO
EQ
EQ
EQ
EQ
EQ
DR REDDYS LABS LTD
EQ
EQ
EQ
EQ
EQ
MYLAN
EQ
EQ
EQ
EQ
EQ
TEVA
EQ
EQ
+
EQ
EQ
EQ
VINTAGE
EQ
EQ
EQ
EQ
EQ
ZYDUS PHARMS USA
EQ
EQ
EQ
EQ
EQ

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

A078932
A078932
A078932
A079098
A079098
A079098
A079098
A079098
A090555
A090555
A090555
A090555
A090555
A078627
A078627
A078627
A078627
A078627
A078301
A078301
A078301
A078301
A078301
A077166
A077166
A077166
A077166
A077166
A076690
A076690
A076690
A076690
A076690
A090027
A090027
A090027
A090027
A090027
A077653
A077653
A077653
A077653
A077653

003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005
001
002
003
004
005

Dec
Dec
Dec
May
May
May
May
May
Apr
Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Jun
Jun
Jun
Jun
Jun

14,
14,
14,
11,
11,
11,
11,
11,
07,
07,
07,
07,
07,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,
03,
03,
03,
03,
03,
04,
04,
04,
04,
04,
13,
13,
13,
13,
13,

2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2006
2006
2006
2006
2006
2010
2010
2010
2010
2010
2008
2008
2008
2008
2008

TABLET, EXTENDED RELEASE; ORAL

VENLAFAXINE HYDROCHLORIDE
OSMOTICA PHARM
EQ 37.5MG BASE
EQ 75MG BASE
+
EQ 150MG BASE
SUN PHARMA GLOBAL
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
VENLAFAXINE HYDROCHLORIDE
OSMOTICA PHARM
EQ 225MG BASE

N022104
N022104
N022104
A091272
A091272
A091272

001
002
003
001
002
003

May
May
May
Aug
Aug
Aug

20,
20,
20,
18,
18,
18,

2008
2008
2008
2010
2010
2010

N022104 004

May 20, 2008

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 416 (of 424)

VERAPAMIL HYDROCHLORIDE

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
XX

CAPSULE, EXTENDED RELEASE; ORAL

VERAPAMIL HYDROCHLORIDE
MYLAN
100MG
120MG
180MG
200MG
240MG
300MG
VERELAN
ALKERMES GAINESVILLE 120MG
180MG
240MG
VERELAN PM
ELAN DRUG
100MG
200MG
+
300MG
VERELAN
+ ALKERMES GAINESVILLE 360MG

INJECTABLE; INJECTION
VERAPAMIL HYDROCHLORIDE
HOSPIRA
AP
AP
AP
INTL MEDICATION
AP
TABLET; ORAL
CALAN
GD SEARLE LLC
AB
AB
AB +
VERAPAMIL HYDROCHLORIDE
MYLAN
AB
AB
WATSON LABS
AB
AB
AB
AB
AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET, EXTENDED RELEASE;

ISOPTIN SR
+ PFIZER
+
+
VERAPAMIL HYDROCHLORIDE
GLENMARK GENERICS

IVAX SUB TEVA PHARMS

MYLAN

PAR PHARM
SUN PHARM INDS INC

A078306
A075138
A075138
A078306
A075138
A078306

001
001
002
002
003
003

Aug
Apr
Apr
Aug
Apr
Aug

09,
20,
20,
09,
20,
09,

2007
1999
1999
2007
1999
2007

N019614 001
N019614 003
N019614 002

May 29, 1990

Jan 09, 1992
May 29, 1990

N020943 001
N020943 002
N020943 003

Nov 25, 1998

Nov 25, 1998
Nov 25, 1998

N019614 004

May 10, 1996

2.5MG/ML
2.5MG/ML
2.5MG/ML
2.5MG/ML

A070737
A070738
A075136
A070451

May
May
Oct
Dec

40MG
80MG
120MG

N018817 003
N018817 001
N018817 002

Feb 23, 1988

Sep 10, 1984
Sep 10, 1984

80MG
120MG
40MG
40MG
80MG
80MG
80MG
120MG
120MG
120MG

A071482
A071483
A072923
A072924
A070855
A070995
A071366
A070856
A070994
A071367

Feb
Feb
Jun
Jun
Sep
Oct
Oct
Sep
Oct
Oct

001
001
001
001

001
001
001
001
001
001
001
001
001
001

06,
06,
20,
16,

15,
15,
29,
29,
24,
01,
01,
24,
01,
01,

1987
1987
1998
1985

1989
1989
1993
1993
1986
1986
1986
1986
1986
1986

ORAL
120MG
180MG
240MG

N019152 003
N019152 002
N019152 001

Mar 06, 1991

Dec 15, 1989
Dec 16, 1986

120MG
180MG
240MG
120MG
180MG
240MG
120MG
180MG
240MG
120MG
240MG
120MG
180MG

A090700
A090700
A078906
A073568
A074330
A073568
A074587
A074587
A074587
A075072
A075072
A090529
A090529

Aug
Aug
Sep
Oct
Jan
Jul
Feb
Sep
Mar
May
May
Dec
Dec

001
002
001
002
001
001
002
003
001
001
003
001
002

03,
03,
17,
10,
31,
31,
21,
09,
23,
25,
25,
30,
30,

2011
2011
2009
1997
1994
1992
1997
1997
1996
1999
1999
2011
2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 417 (of 424)

VERAPAMIL HYDROCHLORIDE
TABLET, EXTENDED RELEASE;
VERAPAMIL HYDROCHLORIDE
SUN PHARM INDS INC
AB
COVERA-HS
BC + GD SEARLE LLC
BC +

ORAL
240MG

A090529 003

Dec 30, 2011

180MG
240MG

N020552 001
N020552 002

Feb 26, 1996

Feb 26, 1996

15MG/VIAL

N021119 001

Apr 12, 2000

FOR SOLUTION; ORAL

SABRIL

XX + LUNDBECK INC

500MG/PACKET

N022006 001

Aug 21, 2009

TABLET; ORAL

SABRIL

XX + LUNDBECK INC

500MG

N020427 001

Aug 21, 2009

10MG
20MG
40MG

N022567 001
N022567 002
N022567 003

Jan 21, 2011

Jan 21, 2011
Jan 21, 2011

1MG/ML
10MG/VIAL

A089515 001
A089395 001

Apr 29, 1987

Apr 09, 1987

A071484 001
A075493 001

Apr 19, 1988

Sep 01, 1999

EQ 10MG BASE/ML

N020388 001

Dec 23, 1994

EQ
EQ
EQ
EQ
EQ
EQ
EQ

A078011
A076849
A075992
A076461
A078408
A076827
A076028

Jul
Apr
Jun
Dec
Feb
Jun
Feb

VERTEPORFIN
INJECTABLE; INJECTION

VISUDYNE

XX + QLT

VIGABATRIN

VILAZODONE HYDROCHLORIDE
TABLET; ORAL
VIIBRYD
FOREST LABS INC
XX
XX
XX +

VINBLASTINE SULFATE
INJECTABLE; INJECTION

VINBLASTINE SULFATE

XX + APP PHARMS
XX + BEDFORD

VINCRISTINE SULFATE
INJECTABLE; INJECTION
VINCRISTINE SULFATE PFS
AP + HOSPIRA
1MG/ML
TEVA PARENTERAL
AP
1MG/ML

VINORELBINE TARTRATE

AP
AP
AP
AP
AP
AP
AP
AP

INJECTABLE; INJECTION
NAVELBINE
+ PIERRE FABRE
VINORELBINE TARTRATE
ACTAVIS TOTOWA
APP PHARMS
BAXTER HLTHCARE
BEDFORD
EBEWE PHARMA
HOSPIRA
TEVA PARENTERAL

10MG
10MG
10MG
10MG
10MG
10MG
10MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

001
001
001
001
001
001
001

VITAMIN A PALMITATE
INJECTABLE; INJECTION

AQUASOL A

XX + HOSPIRA

EQ 50,000 UNITS BASE/ML

N006823 001

22,
18,
10,
11,
13,
02,
03,

2009
2005
2003
2003
2008
2005
2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 418 (of 424)

VORICONAZOLE
FOR SUSPENSION; ORAL

VFEND

XX + PFIZER

200MG/5ML

N021630 001

Dec 19, 2003

N021267 001

May 24, 2002

50MG
200MG

N021266 001
N021266 002

May 24, 2002

May 24, 2002

50MG
200MG
50MG
200MG

A090547
A090547
A200265
A200265

Apr
Apr
Dec
Dec

100MG

N021991 001

Oct 06, 2006

5MG/VIAL

N009218 024

Feb 07, 1995

1MG
2MG
2.5MG
3MG
4MG
5MG
6MG
7.5MG
10MG

N009218
N009218
N009218
N009218
N009218
N009218
N009218
N009218
N009218

022
013
018
025
023
007
026
016
005

Mar 01, 1990

1MG
2MG
2.5MG
3MG
4MG
5MG
6MG
7.5MG
10MG

A040416
A040416
A040416
A040416
A040416
A040416
A040416
A040416
A040416

001
002
003
004
005
006
007
008
009

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

02,
02,
02,
02,
02,
02,
02,
02,
02,

2003
2003
2003
2003
2003
2003
2003
2003
2003

1MG
2MG
2.5MG
3MG
4MG
5MG
6MG
7.5MG
10MG
1MG
2MG

A040145
A040145
A040145
A040145
A040145
A040145
A040145
A040145
A040145
A090935
A090935

001
002
003
008
004
005
009
006
007
001
002

Mar
Mar
Mar
Nov
Mar
Mar
Nov
Mar
Mar
May
May

26,
26,
26,
05,
26,
26,
05,
26,
26,
25,
25,

1997
1997
1997
1998
1997
1997
1998
1997
1997
2011
2011

INJECTABLE; IV (INFUSION)

VFEND

XX + PFIZER
200MG/VIAL
TABLET; ORAL
VFEND
PFIZER
AB
AB +
VORICONAZOLE
MATRIX LABS LTD
AB
AB
SANDOZ INC
AB
AB

001
002
001
002

22,
22,
12,
12,

2010
2010
2011
2011

VORINOSTAT
CAPSULE; ORAL

ZOLINZA

XX + MERCK

WARFARIN SODIUM
INJECTABLE; INJECTION

COUMADIN

XX + BRISTOL MYERS SQUIBB

TABLET; ORAL
COUMADIN
BRISTOL MYERS SQUIBB
AB
AB
AB
AB
AB
AB
AB
AB
AB +
JANTOVEN
USL PHARMA
AB
AB
AB
AB
AB
AB
AB
AB
AB
WARFARIN SODIUM
BARR
AB
AB
AB
AB
AB
AB
AB
AB
AB
INVAGEN PHARMS
AB
AB

Nov 18, 1996

Aug 24, 1993
Nov 18, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 419 (of 424)

WARFARIN SODIUM
TABLET; ORAL
WARFARIN SODIUM
INVAGEN PHARMS
AB
AB
AB
AB
AB
AB
AB
MYLAN
AB
AB
AB
AB
AB
AB
AB
AB
AB
PLIVA
AB
AB
AB
AB
AB
AB
AB
AB
AB
TARO
AB
AB
AB
AB
AB
AB
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB
AB
AB
AB
AB
AB
AB

2.5MG
3MG
4MG
5MG
6MG
7.5MG
10MG
1MG
2MG
2.5MG
3MG
4MG
5MG
6MG
7.5MG
10MG
1MG
2MG
2.5MG
3MG
4MG
5MG
6MG
7.5MG
10MG
1MG
2MG
2.5MG
3MG
4MG
5MG
6MG
7.5MG
10MG
1MG
2MG
2.5MG
3MG
4MG
5MG
6MG
7.5MG
10MG

A090935
A090935
A090935
A090935
A090935
A090935
A090935
A040415
A040415
A040415
A040415
A040415
A040415
A040415
A040415
A040415
A040616
A040616
A040616
A040616
A040616
A040616
A040616
A040616
A040616
A040301
A040301
A040301
A040301
A040301
A040301
A040301
A040301
A040301
A040663
A040663
A040663
A040663
A040663
A040663
A040663
A040663
A040663

003
004
005
006
007
008
009
001
002
003
004
005
006
007
008
009
009
001
002
003
004
005
006
007
008
002
003
004
005
006
007
008
009
001
001
002
003
004
005
006
007
008
009

20mCi/VIAL

N017284 002

10mCi/VIAL

N017284 001

10MG
20MG

N020547 003
N020547 001

May
May
May
May
May
May
May
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
May
May
May
May
May
May
May
May
May

25,
25,
25,
25,
25,
25,
25,
27,
27,
29,
27,
27,
27,
27,
27,
27,
05,
05,
05,
05,
05,
05,
05,
05,
05,
15,
15,
15,
15,
15,
15,
15,
15,
15,
30,
30,
30,
30,
30,
30,
30,
30,
30,

2011
2011
2011
2011
2011
2011
2011
2004
2004
2004
2004
2004
2004
2004
2004
2004
2006
2006
2006
2006
2006
2006
2006
2006
2006
1999
1999
1999
1999
1999
1999
1999
1999
1999
2006
2006
2006
2006
2006
2006
2006
2006
2006

XENON XE-133
GAS; INHALATION
XENON XE 133
LANTHEUS MEDCL
AA
XENON XE 133
XX
LANTHEUS MEDCL

ZAFIRLUKAST
TABLET; ORAL
ACCOLATE
ASTRAZENECA
AB
AB +

Sep 17, 1999

Sep 26, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 420 (of 424)

ZAFIRLUKAST
TABLET; ORAL
ZAFIRLUKAST
DR REDDYS LABS LTD
AB
AB

10MG
20MG

A090372 001
A090372 002

Nov 18, 2010

Nov 18, 2010

5MG
10MG

N020859 001
N020859 002

Aug 13, 1999

Aug 13, 1999

5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG

A078829
A078829
A077505
A077505
A077238
A077238
A090374
A090374
A077237
A077237
A077239
A077239
A078989
A078989
A078706
A078706
A078147
A078147

Jun
Jun
Jun
Jun
Jun
Jun
Sep
Sep
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Nov
Nov

5MG

N021036 001

Jul 26, 1999

100MCG/1ML (100MCG/ML)
500MCG/20ML (25MCG/ML)
500MCG/5ML (100MCG/ML)

N021060 002
N021060 001
N021060 004

Dec 28, 2004

Dec 28, 2004
Dec 28, 2004

100MG

N019655 001

Mar 19, 1987

100MG
100MG

A078128 001
A078349 001

Mar 27, 2006

May 23, 2007

ZALEPLON
CAPSULE; ORAL
SONATA
KING PHARMS
AB
AB +
ZALEPLON
AUROBINDO PHARMA
AB
AB
CIPLA LTD
AB
AB
MYLAN
AB
AB
ORCHID HLTHCARE
AB
AB
ROXANE
AB
AB
TEVA PHARMS
AB
AB
UNICHEM
AB
AB
UPSHER SMITH
AB
AB
WEST WARD
AB
AB

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

06,
06,
20,
20,
06,
06,
17,
17,
06,
06,
06,
06,
06,
06,
06,
06,
25,
25,

2008
2008
2008
2008
2008
2008
2009
2009
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008

ZANAMIVIR
POWDER; INHALATION

RELENZA

XX + GLAXOSMITHKLINE

ZICONOTIDE ACETATE
INJECTABLE; INTRATHECAL

PRIALT

XX + AZUR PHARMA II
XX +
XX +

ZIDOVUDINE
CAPSULE; ORAL
RETROVIR
AB + VIIV HLTHCARE
ZIDOVUDINE
AUROBINDO PHARMA LTD
AB
CIPLA LTD
AB
INJECTABLE; INJECTION
RETROVIR
AP + VIIV HLTHCARE
ZIDOVUDINE
LUITPOLD
AP

10MG/ML

N019951 001

Feb 02, 1990

10MG/ML

A091457 001

May 06, 2010

SYRUP; ORAL
RETROVIR
AA + VIIV HLTHCARE

50MG/5ML

N019910 001

Sep 28, 1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 421 (of 424)

ZIDOVUDINE
SYRUP; ORAL
ZIDOVUDINE
AUROBINDO
AA
CIPLA LTD
AA

50MG/5ML
50MG/5ML

A077268 001
A077981 001

Sep 19, 2005

Jun 26, 2008

300MG

N020518 002

Oct 04, 1996

300MG
300MG
300MG
300MG
300MG
300MG
300MG

A077267
A090561
A202058
A090092
A078922
A077327
A076844

Sep
Oct
Oct
Apr
Feb
Sep
Sep

600MG

N020471 003

Dec 09, 1996

TABLET, EXTENDED RELEASE; ORAL

ZYFLO CR

600MG
XX + CORNERSTONE THERAP

N022052 001

May 30, 2007

N020458 001
N020458 002

Jan 28, 1997

Jan 28, 1997

N018959 001

Jun 26, 1986

N020825
N020825
N020825
N020825

Feb
Feb
Feb
Feb

AB
AB
AB
AB
AB
AB
AB
AB

TABLET; ORAL
RETROVIR
+ VIIV HLTHCARE
ZIDOVUDINE
AUROBINDO
CIPLA
HEC PHARM INC
HETERO DRUGS LTD
MATRIX LABS LTD
RANBAXY
ROXANE

001
001
001
001
001
001
001

19,
27,
07,
25,
14,
19,
19,

2005
2010
2011
2008
2008
2005
2005

ZILEUTON
TABLET; ORAL

ZYFLO

XX + CORNERSTONE THERAP

ZINC ACETATE
CAPSULE; ORAL
GALZIN
TEVA
XX
XX +

EQ 25MG ZINC
EQ 50MG ZINC

ZINC CHLORIDE
INJECTABLE; INJECTION

ZINC CHLORIDE IN PLASTIC CONTAINER

XX + HOSPIRA
EQ 1MG ZINC/ML

ZIPRASIDONE HYDROCHLORIDE
CAPSULE; ORAL

GEODON

XX + PFIZER
XX
XX
XX

EQ
EQ
EQ
EQ

SUSPENSION; ORAL

GEODON

XX + PFIZER INC

EQ 10MG BASE/ML

N021483 001

Mar 29, 2006

INJECTABLE; INTRAMUSCULAR

GEODON

EQ 20MG BASE/ML
XX + PFIZER

N020919 001

Jun 21, 2002

N021817 001

Apr 16, 2007

N021223 002
N021223 003

Mar 07, 2003

Jun 17, 2011

20MG
40MG
60MG
80MG

BASE
BASE
BASE
BASE

001
002
003
004

05,
05,
05,
05,

2001
2001
2001
2001

ZIPRASIDONE MESYLATE

ZOLEDRONIC ACID
INJECTABLE; IV (INFUSION)

RECLAST

XX + NOVARTIS
EQ 5MG BASE/100ML
ZOMETA
XX + NOVARTIS
EQ 4MG BASE/5ML
XX +
EQ 4MG BASE/100ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 422 (of 424)

ZOLMITRIPTAN
SPRAY; NASAL

ZOMIG

XX + ASTRAZENECA

5MG/SPRAY

N021450 004

Sep 30, 2003

TABLET; ORAL
ZOMIG
IPR
XX
XX +

2.5MG
5MG

N020768 001
N020768 002

Nov 25, 1997

Nov 25, 1997

N021231 001
N021231 002

Feb 13, 2001

Sep 17, 2001

5MG/SPRAY

N022196 001

Dec 19, 2008

TABLET, ORALLY DISINTEGRATING; ORAL

ZOMIG-ZMT
XX
ASTRAZENECA
2.5MG
XX +
5MG

ZOLPIDEM TARTRATE
SPRAY, METERED; ORAL

ZOLPIMIST

XX + NOVADEL
TABLET; ORAL
AMBIEN
SANOFI AVENTIS US
AB
AB +
ZOLPIDEM TARTRATE
APOTEX INC
AB
AB
AUROBINDO PHARMA
AB
AB
CARACO
AB
AB
CARLSBAD
AB
AB
DR REDDYS LABS LTD
AB
AB
HIKMA
AB
AB
INVAGEN PHARMS
AB
AB
LEK PHARMS DD
AB
AB
MYLAN
AB
AB
AB
AB
RANBAXY
AB
AB
ROXANE
AB
AB
TEVA
AB
AB
TORRENT PHARMS
AB
AB
VINTAGE
AB
AB
WATSON LABS
AB
AB
WOCKHARDT
AB
AB

5MG
10MG

N019908 001
N019908 002

Dec 16, 1992

Dec 16, 1992

5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
5MG
10MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG

A077884
A077884
A078413
A078413
A077359
A077359
A077990
A077990
A077985
A077985
A078129
A078129
A078184
A078184
A077322
A077322
A076578
A078016
A076578
A078016
A078055
A078055
A077214
A077214
A076410
A076410
A077903
A077903
A078616
A078616
A077773
A077773
A078426
A078426

Apr
Apr
May
May
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Sep
Sep
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Aug
Aug
Nov
Nov
Apr
Apr
May
May

TABLET; SUBLINGUAL
EDLUAR
MEDA PHARMS
XX

5MG

N021997 001

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
001
002
002
001
002
001
002
001
002
001
002
001
002
001
002
001
002

23,
23,
04,
04,
23,
23,
23,
23,
23,
23,
30,
30,
07,
07,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
23,
17,
17,
21,
21,
23,
23,
15,
15,

2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2008
2008
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2008
2008
2007
2007
2007
2007

Mar 13, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 423 (of 424)

ZOLPIDEM TARTRATE
TABLET; SUBLINGUAL

EDLUAR

XX + MEDA PHARMS
INTERMEZZO
PURDUE PHARMA
XX
XX +

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

TABLET, EXTENDED RELEASE;

AMBIEN CR
SANOFI AVENTIS US
+
ZOLPIDEM TARTRATE
ACTAVIS S ATLANTIC
ANCHEN PHARMS
SANDOZ
SYNTHON PHARMS
ZOLPIDEM TATRATE
ACTAVIS S ATLANTIC

10MG

N021997 002

Mar 13, 2009

1.75MG
3.5MG

N022328 001
N022328 002

Nov 23, 2011

Nov 23, 2011

6.25MG
12.5MG

N021774 002
N021774 001

Sep 02, 2005

Sep 02, 2005

6.25MG
6.25MG
12.5MG
6.25MG
12.5MG
6.25MG
12.5MG

A078179
A078148
A078148
A090107
A090107
A078483
A078483

Oct
Apr
Dec
Jul
Jul
Apr
Jun

12.5MG

A078179 001

Jun 06, 2011

25MG
50MG
100MG

N020789 003
N020789 002
N020789 001

Aug 22, 2003

Aug 22, 2003
Mar 27, 2000

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

A077647
A077647
A077647
A077642
A077642
A077642
A077813
A077813
A077813
A077639
A077639
A077639
A077876
A077876
A077876
A077645
A077645
A077645
A077651
A077651
A077651
A077869
A077869
A077869
A077637
A077637
A077637
A077644
A077644
A077644
A077634

Dec
Dec
Dec
Dec
Dec
Dec
Aug
Aug
Aug
Dec
Dec
Dec
Feb
Feb
Feb
Sep
Sep
Dec
Jan
Jan
Jan
May
May
May
Dec
Dec
Dec
Dec
Dec
Dec
Mar

ORAL

002
002
001
001
002
001
002

13,
14,
03,
01,
01,
12,
06,

2010
2011
2010
2011
2011
2011
2011

ZONISAMIDE
CAPSULE; ORAL
ZONEGRAN
EISAI INC
AB
AB
AB +
ZONISAMIDE
ALPHAPHARM
AB
AB
AB
APOTEX INC
AB
AB
AB
BANNER PHARMACAPS
AB
AB
AB
BARR
AB
AB
AB
COREPHARMA
AB
AB
AB
DR REDDYS LABS LTD
AB
AB
AB
GLENMARK GENERICS
AB
AB
AB
INVAGEN PHARMS
AB
AB
AB
MYLAN
AB
AB
AB
SANDOZ
AB
AB
AB
SUN PHARM INDS (IN)
AB

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
002
003
001
001
002
003
001
002
003
001
002
003
001
002
003
001

22,
22,
22,
22,
22,
22,
16,
16,
16,
22,
22,
22,
21,
21,
21,
29,
29,
22,
30,
30,
30,
31,
31,
31,
22,
22,
22,
22,
22,
22,
17,

2005
2005
2005
2005
2005
2005
2006
2006
2006
2005
2005
2005
2007
2007
2007
2006
2006
2005
2006
2006
2006
2006
2006
2006
2005
2005
2005
2005
2005
2005
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PRESCRIPTION DRUG PRODUCT LIST

3 - 424 (of 424)

ZONISAMIDE
CAPSULE; ORAL
ZONISAMIDE
SUN PHARM INDS (IN)
AB
AB
WOCKHARDT
AB
AB
AB
ZYDUS PHARMS USA
AB
AB
AB

50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG

A077634
A077634
A077636
A077636
A077636
A077625
A077625
A077625

002
003
003
002
001
001
002
003

Mar
Mar
Jul
Jul
Dec
Oct
Oct
Oct

17,
17,
27,
27,
22,
16,
16,
16,

2006
2006
2006
2006
2005
2006
2006
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 1 (of 19)

ACETAMINOPHEN
SUPPOSITORY; RECTAL
ACEPHEN
G AND W LABS

ACETAMINOPHEN
ACTAVIS MID ATLANTIC
+
PERRIGO NEW YORK
INFANTS' FEVERALL
ACTAVIS MID ATLANTIC
NEOPAP
POLYMEDICA
TABLET, EXTENDED RELEASE;
ACETAMINOPHEN
OHM LABS
PERRIGO
RANBAXY LABS LTD
TYLENOL (CAPLET)
+ MCNEIL CONS
TYLENOL (GELTAB)
+ MCNEIL CONS

120MG
325MG
325MG
650MG
650MG

N018060
A072344
N018060
A072237
N018060

001
001
003
001
002

120MG
325MG
650MG
120MG
650MG

N018337
N018337
N018337
A070607
A070608

003
002
001
001
001

Sep 12, 1983

80MG

N018337

004

Aug 26, 1992

120MG
ORAL

N016401

001

650MG
650MG
650MG

A076200
A075077
A078569

001
001
001

Mar 19, 2002

Feb 25, 2000
Dec 14, 2011

650MG

N019872

001

Jun 08, 1994

650MG

N019872

002

Jan 11, 2001

A075794

001

Nov 26, 2001

N020802

001

Jan 14, 1998

001

Mar 01, 2001

N019453

001

May 22, 1987

N021074

001

Jun 07, 2001

80MG;20MG

A071793

001

Sep 04, 1987

80MG;20MG
160MG;40MG

N018685
N018685

001
002

Dec 09, 1983

Dec 09, 1983

2%;2%;10%

N021502

001

Jul 21, 2006

2%;3%;10%

N021501

001

Oct 02, 2006

Mar 27, 1992

Dec 18, 1986
Mar 27, 1992

Apr 06, 1987

Dec 01, 1986

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

N021082

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
GAVISCON
SANOFI AVENTIS US
+

AVOBENZONE; ECAMSULE; OCTOCRYLENE

CREAM; TOPICAL

ANTHELIOS SX

+ LOREAL USA
CAPITAL SOLEIL 15
+ LOREAL USA

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 2 (of 19)

AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE

CREAM; TOPICAL

ANTHELIOS 20

+ LOREAL USA
ANTHELIOS 40
+ LOREAL USA
+

2%;2%;10%;2%

N021471

001

Oct 05, 2006

2%;3%;10%;5%
2%;3%;10%;5%

N022009
N022009

001
002

Mar 31, 2008

Oct 29, 2009

3%;7.5%;3%

N020045

001

Dec 07, 1992

5%

N020532

001

Aug 26, 1996

1%

N021307

001

Dec 07, 2001

2%

N020421

001

Dec 21, 1995

A077355

001

Feb 06, 2008

N020958

001

Oct 16, 2000

N022429
N022429

001
004

Jul 23, 2009

Jul 23, 2009

N022429
N022429

003
002

Jul 23, 2009

Jul 23, 2009

A090765
A090188
A090750
A090300
A090474
A090254
A090183
A091130
A091327
A090182
A201546

002
002
002
001
002
002
002
001
001
002
001

Oct
Apr
Feb
Oct
Mar
Apr
Apr
Apr
Oct
Apr
May

07,
22,
02,
10,
30,
09,
24,
22,
17,
22,
20,

2009
2008
2010
2008
2009
2008
2008
2011
2011
2008
2011

A090765
A090188
A090750
A090300
A090474
A090254
A090183

001
001
001
002
001
001
001

Oct
Apr
Feb
Oct
Mar
Apr
Apr

07,
22,
02,
10,
30,
09,
24,

2009
2008
2010
2008
2009
2008
2008

AVOBENZONE; OCTINOXATE; OXYBENZONE

LOTION; TOPICAL

SHADE UVAGUARD

+ SCHERING PLOUGH

BENTOQUATAM
LOTION; TOPICAL

IVY BLOCK

+ STAND HOMEOPATH

BUTENAFINE HYDROCHLORIDE
CREAM; TOPICAL

LOTRIMIN ULTRA

+ SCHERING PLOUGH

BUTOCONAZOLE NITRATE
CREAM; VAGINAL

FEMSTAT 3

+ BAYER

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

TABLET, CHEWABLE; ORAL
CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE
PERRIGO R AND D
800MG;10MG;165MG
PEPCID COMPLETE
+ MERCK SHARP DOHME
800MG;10MG;165MG

CETIRIZINE HYDROCHLORIDE
CAPSULE; ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
BANNER PHARMACAPS
5MG
+
10MG
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
BANNER PHARMACAPS
5MG
+
10MG
SYRUP; ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
AMNEAL PHARMS
5MG/5ML
APOTEX
5MG/5ML
AUROBINDO PHARMA
5MG/5ML
CYPRESS PHARM
5MG/5ML
DR REDDYS LABS LTD
5MG/5ML
PERRIGO R AND D
5MG/5ML
RANBAXY
5MG/5ML
SILARX
5MG/5ML
SUN PHARM INDS INC
5MG/5ML
TARO
5MG/5ML
5MG/5ML
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
AMNEAL PHARMS
5MG/5ML
APOTEX
5MG/5ML
AUROBINDO PHARMA
5MG/5ML
CYPRESS PHARM
5MG/5ML
DR REDDYS LABS LTD
5MG/5ML
PERRIGO R AND D
5MG/5ML
RANBAXY
5MG/5ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 3 (of 19)

CETIRIZINE HYDROCHLORIDE
SYRUP; ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
SILARX
5MG/5ML
SUN PHARM INDS INC
5MG/5ML
TARO
5MG/5ML
5MG/5ML
CHILDREN'S ZYRTEC ALLERGY
+ MCNEIL CONSUMER
5MG/5ML
CHILDREN'S ZYRTEC HIVES RELIEF
+ MCNEIL CONSUMER
5MG/5ML
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
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
SUN PHARMA GLOBAL
5MG
10MG
CHILDREN'S ZYRTEC ALLERGY
PFIZER
5MG
+
10MG
CHILDREN'S ZYRTEC HIVES RELIEF
PFIZER
5MG
+
10MG
TABLET, ORALLY DISINTEGRATING; ORAL
ZYRTEC ALLERGY
+ MCNEIL CONSUMER
10MG
TABLET; ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS ELIZABETH
5MG
10MG
AMNEAL PHARMS NY
5MG
10MG
APOTEX INC
5MG
10MG
CADISTA PHARMS
5MG
10MG
CARACO
5MG
10MG
CONTRACT PHARMA
5MG
10MG
DR REDDYS LABS LTD
5MG
10MG
MYLAN
5MG
10MG
ORCHID HLTHCARE
5MG
10MG
PERRIGO R AND D
5MG
10MG
RANBAXY
5MG
10MG
SANDOZ
5MG
10MG
TARO
5MG
5MG
TORRENT PHARMS LLC
5MG
10MG

A091130
A091327
A090182
A201546

002
002
001
002

Apr
Oct
Apr
May

22,
17,
22,
20,

N022155

002

Nov 16, 2007

N022155

001

Nov 16, 2007

A077631
A077631
A078692
A078692

004
003
001
002

Jan
Jan
Feb
Feb

A077631
A077631

001
002

Jan 11, 2008

Jan 11, 2008

A090142
A090142

001
002

Aug 30, 2011

Aug 30, 2011

A090142
A090142

003
004

Aug 30, 2011

Aug 30, 2011

N021621
N021621

003
004

Nov 16, 2007

Nov 16, 2007

N021621
N021621

005
006

Nov 16, 2007

Nov 16, 2007

N022578

001

Sep 03, 2010

A078615
A078615
A078780
A078780
A078317
A078317
A078933
A078933
A077499
A077499
A076047
A076047
A078343
A078343
A076677
A076677
A078862
A078862
A078336
A078336
A077498
A077498
A077946
A077946
A078072
A078072
A079191
A079191

003
004
001
004
001
002
001
002
001
002
001
002
004
003
001
002
001
002
001
002
001
002
001
002
001
003
001
004

Dec
Dec
Jan
Jan
Dec
Dec
Jun
Jun
Dec
Dec
Dec
Dec
Jan
Jan
Dec
Dec
Feb
Feb
Dec
Dec
Dec
Dec
Dec
Dec
Jul
Jul
Apr
Apr

11,
11,
14,
14,

28,
28,
21,
21,
27,
27,
15,
15,
27,
27,
27,
27,
15,
15,
27,
27,
19,
19,
27,
27,
27,
27,
27,
27,
22,
22,
15,
15,

2011
2011
2008
2011

2008
2008
2008
2008

2007
2007
2010
2010
2007
2007
2010
2010
2007
2007
2007
2007
2008
2008
2007
2007
2009
2009
2007
2007
2007
2007
2007
2007
2009
2009
2010
2010

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

4 - 4 (of 19)

OTC DRUG PRODUCT LIST

CETIRIZINE HYDROCHLORIDE
TABLET; ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
UNICHEM
5MG
10MG
UNIQUE PHARM LABS
5MG
10MG
WOCKHARDT
5MG
10MG
CETIRIZINE HYDROCHLORIDE HIVES
CADISTA PHARMS
5MG
10MG
CARACO
5MG
10MG
DR REDDYS LABS LTD
5MG
10MG
MYLAN
5MG
10MG
ORCHID HLTHCARE
5MG
10MG
PERRIGO R AND D
5MG
10MG
RANBAXY
5MG
10MG
UNICHEM
5MG
10MG
UNIQUE PHARM LABS
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

A078680
A078680
A077829
A077829
A078427
A078427

003
004
001
004
003
004

Jun
Jun
Aug
Aug
Dec
Dec

26,
26,
26,
26,
28,
28,

2009
2009
2009
2009
2007
2007

A078933
A078933
A077499
A077499
A078343
A078343
A076677
A076677
A078862
A078862
A078336
A078336
A077498
A077498
A078680
A078680
A077829
A077829

003
004
003
004
001
002
004
003
003
004
003
004
003
004
001
002
003
002

Jun
Jun
Dec
Dec
Jan
Jan
Dec
Dec
Feb
Feb
Dec
Dec
Dec
Dec
Jun
Jun
Aug
Aug

15,
15,
27,
27,
15,
15,
27,
27,
19,
19,
27,
27,
27,
27,
26,
26,
26,
26,

2010
2010
2007
2007
2008
2008
2007
2007
2009
2009
2007
2007
2007
2007
2009
2009
2009
2009

A078780
A078780
A078072
A078072
A079191
A079191

003
002
002
004
003
002

Jan
Jan
Jul
Jul
Apr
Apr

21,
21,
22,
22,
15,
15,

2010
2010
2009
2009
2010
2010

N019835
N019835

003
004

Nov 16, 2007

Nov 16, 2007

N019835
N019835

005
006

Nov 16, 2007

Nov 16, 2007

A077170
A077991

001
001

Feb 25, 2008

Mar 05, 2008

N021150

002

Nov 09, 2007

4%

N019127

001

Dec 24, 1984

2%

N021669

001

Apr 25, 2005

4%

A071419

001

Dec 17, 1987

4%

N019258

002

Jul 22, 1986

2%

N019258

001

Jul 22, 1986

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 5MG;120MG
SANDOZ
5MG;120MG
ZYRTEC-D 12 HOUR
+ MCNEIL
5MG;120MG

CHLORHEXIDINE GLUCONATE
AEROSOL, METERED; TOPICAL

EXIDINE

+ XTTRIUM
CLOTH; TOPICAL

CHLORHEXIDINE GLUCONATE

+ SAGE PRODS
SOLUTION; TOPICAL
BRIAN CARE
SOAPCO
CHG SCRUB
ECOLAB
CIDA-STAT
ECOLAB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 5 (of 19)

CHLORHEXIDINE GLUCONATE
SOLUTION; TOPICAL
DYNA-HEX
XTTRIUM
EXIDINE
+ XTTRIUM
HIBICLENS
+ MOLNLYCKE HLTH
HIBISTAT

+ MOLNLYCKE HLTH
SPONGE; TOPICAL
BIOSCRUB
GRIFFEN
CHLORHEXIDINE GLUCONATE
BECTON DICKINSON
PHARMASEAL SCRUB CARE
+ CAREFUSION

0.75%

N020111

001

Sep 11, 1997

2%
4%

N019422
N019125

001
001

Dec 17, 1985

Dec 24, 1984

4%

N017768

001

0.5%

N018300

001

4%

N019822

001

Mar 31, 1989

4%

A072525

001

Oct 24, 1989

4%

N019793

001

Dec 02, 1988

N020832
N020832
N020832

001
004
006

Jul 14, 2000

Aug 20, 2003
Nov 21, 2006

N020832

003

Apr 26, 2002

N020832
N020832
N020832

002
005
007

May 03, 2005

Apr 03, 2006
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

N021524

002

Jun 03, 2005

A040829

001

May 13, 2009

N007638

002

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

SPONGE; TOPICAL

CHLORAPREP ONE-STEP

+ CAREFUSION
2%;70% (3ML)
+
2%;70% (10.5ML)
+
2%;70% (26ML)
CHLORAPREP ONE-STEP FREPP
+ CAREFUSION
2%;70% (1.5ML)
CHLORAPREP WITH TINT
+ CAREFUSION
2%;70% (26ML)
+
2%;70% (10.5ML)
+
2%;70% (3ML)
SWAB; TOPICAL

CHLORAPREP ONE-STEP SEPP

+ CARDINAL HLTH
2%;70% (0.67ML)
CHLORAPREP SINGLE SWABSTICK
+ CARDINAL HLTH
2%;70% (1.75ML)
CHLORAPREP TRIPLE SWABSTICK
+ CARDINAL HLTH
2%;70% (5.25ML)
CHLORASCRUB MAXI SWABSTICK
+ 3M INFECTION
3.15%;70% (5.1ML)
CHLORASCRUB SWAB
+ 3M INFECTION
3.15%;70% (1ML)
CHLORASCRUB SWABSTICK
+ 3M INFECTION
3.15%;70% (1.6ML)

CHLORPHENIRAMINE MALEATE
TABLET, EXTENDED RELEASE; ORAL
CHLORPHENIRAMINE MALEATE
AVANTHI INC
12MG
CHLOR-TRIMETON
+ SCHERING PLOUGH
12MG

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

TABLET; ORAL

ADVIL ALLERGY AND CONGESTION RELIEF

+ PFIZER CONS HLTHCARE 4MG;200MG;10MG

N022113

001

Dec 21, 2011

N021587

001

Feb 24, 2004

N021441

001

Dec 19, 2002

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

SUSPENSION; ORAL

CHILDREN'S ADVIL ALLERGY SINUS

+ WYETH CONS
1MG/5ML;100MG/5ML;15MG/5ML
TABLET; ORAL

ADVIL ALLERGY SINUS

+ WYETH CONS
2MG;200MG;30MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 6 (of 19)

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE; ORAL

CHLOR-TRIMETON

+ SCHERING PLOUGH
8MG;120MG

N018397

001

100MG
200MG
200MG
200MG
200MG
200MG
200MG

A074948
A074948
A074961
A074963
A075345
A075285
A075425

001
002
001
001
001
001
001

Jun
Jul
Jun
Jun
Jun
Oct
Jul

200MG

N020238

002

Aug 21, 1996

1.34MG
1.34MG

A074512
A073458

001
001

Nov 22, 1995

Oct 31, 1993

1.34MG

N020925

001

Aug 21, 1992

N020526

002

Jul 29, 1996

N020289

002

Apr 26, 1993

N020389

002

Jun 23, 1994

A074165
A072641

001
001

Jul 16, 1993

Dec 04, 1995

N018052

002

Nov 30, 1990

N020574

001

Nov 24, 1998

N018230

002

Dec 26, 1991

N021143

001

Apr 12, 2000

N017717

002

Nov 30, 1990

N020525

001

Jul 29, 1996

N018182

002

Dec 26, 1991

A075702
A077976
A075427

001
001
001

Jul 03, 2001

Sep 07, 2007
Dec 12, 2001

CIMETIDINE
TABLET; ORAL
CIMETIDINE
APOTEX
CONTRACT PHARMACAL
IVAX SUB TEVA PHARMS
PERRIGO
WATSON LABS
TAGAMET HB
+ GLAXOSMITHKLINE

19,
26,
19,
19,
16,
29,
29,

1998
2002
1998
1998
1999
1998
1999

CLEMASTINE FUMARATE
TABLET; ORAL
CLEMASTINE FUMARATE
PERRIGO
SANDOZ
TAVIST-1
+ NOVARTIS

CLOTRIMAZOLE
CREAM, TABLET; TOPICAL, VAGINAL

GYNE-LOTRIMIN 3 COMBINATION PACK

+ SCHERING PLOUGH
1%,200MG
GYNE-LOTRIMIN COMBINATION PACK
+ SCHERING PLOUGH
1%,100MG
MYCELEX-7 COMBINATION PACK
BAYER PHARMS
1%,100MG
CREAM; VAGINAL
CLOTRIMAZOLE
ACTAVIS MID ATLANTIC 1%
TARO
1%
GYNE-LOTRIMIN
+ SCHERING PLOUGH
1%
GYNE-LOTRIMIN 3
+ SCHERING PLOUGH
2%
MYCELEX-7
BAYER PHARMS
1%
TRIVAGIZOLE 3
TARO
2%
TABLET; VAGINAL

GYNE-LOTRIMIN

+ SCHERING PLOUGH
100MG
GYNE-LOTRIMIN 3
+ SCHERING PLOUGH
200MG
MYCELEX-7
BAYER PHARMS
100MG

CROMOLYN SODIUM
SPRAY, METERED; NASAL

CROMOLYN SODIUM

+ BAUSCH AND LOMB

HH AND P
PERRIGO

5.2MG/SPRAY
5.2MG/SPRAY
5.2MG/SPRAY

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 7 (of 19)

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE; ORAL
DISOPHROL
SCHERING PLOUGH
6MG;120MG
DRIXORAL
+ SCHERING PLOUGH
6MG;120MG

N013483

004

Sep 13, 1982

N013483

003

Sep 13, 1982

N021620
N021620

002
001

Apr 29, 2004

Apr 29, 2004

N018658

001

Oct 08, 1982

N021394

001

Dec 21, 2005

A090619
A079113

001
001

Jul 08, 2009

Dec 22, 2008

N021393

001

Dec 21, 2005

A090397

001

Nov 22, 2010

10%

N020941

001

Jul 25, 2000

25MG
25MG

A040564
A040167

001
001

Aug 27, 2004

Sep 18, 1996

25MG

N018066

001

A087907

001

May 23, 1984

10MG

A075715

001

Aug 22, 2003

20MG

N020801

002

Dec 17, 2007

10MG
20MG
10MG

A075758
A077367
A075512

001
001
001

Aug 17, 2001

Sep 25, 2006
Jul 26, 2001

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

TABLET, EXTENDED RELEASE; ORAL
MUCINEX DM
RECKITT BENCKISER
30MG;600MG
+
60MG;1.2GM

DEXTROMETHORPHAN POLISTIREX
SUSPENSION, EXTENDED RELEASE; ORAL

DELSYM

+ RECKITT BENCKISER
EQ 30MG HBR/5ML

DIPHENHYDRAMINE CITRATE; IBUPROFEN

TABLET; ORAL

ADVIL PM

+ PFIZER CONS HLTHCARE 38MG;200MG

IBUPROFEN AND DIPHENHYDRAMINE CITRATE
DR REDDYS LABS LTD
38MG;200MG
PERRIGO R AND D
38MG;200MG

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

CAPSULE; ORAL

ADVIL PM

+ WYETH CONS

25MG;EQ 200MG FREE ACID AND POTASSIUM

SALT
IBUPROFEN AND DIPHENHYDRAMINE
BANNER PHARMACAPS
25MG;EQ 200MG FREE ACID AND POTASSIUM
SALT

DOCOSANOL
CREAM; TOPICAL

ABREVA

+ GLAXOSMITHKLINE

DOXYLAMINE SUCCINATE
TABLET; ORAL
DOXYLAMINE SUCCINATE
LNK
PERRIGO
UNISOM
+ CHATTEM

EPINEPHRINE
AEROSOL, METERED; INHALATION
EPINEPHRINE
ARMSTRONG PHARMS
0.2MG/INH

FAMOTIDINE
TABLET, CHEWABLE; ORAL
FAMOTIDINE
PERRIGO
PEPCID AC
+ MERCK SHARP DOHME
TABLET; ORAL
FAMOTIDINE
DR REDDYS LABS LTD
IVAX SUB TEVA PHARMS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 8 (of 19)

FAMOTIDINE
TABLET; ORAL
FAMOTIDINE
MYLAN
PERRIGO
RANBAXY
SANDOZ
TEVA
WATSON LABS
WOCKHARDT
PEPCID AC
MERCK SHARP DOHME
+
PEPCID AC (GELTAB)
MERCK SHARP DOHME

10MG
10MG
20MG
10MG
20MG
10MG
10MG
10MG
10MG
20MG

A075674
A075400
A077351
A090283
A090283
A076101
A075312
A075404
A077146
A090837

001
001
001
001
002
001
001
001
001
001

Dec
Mar
Sep
Nov
Nov
Oct
May
Nov
Mar
Aug

21,
18,
25,
17,
17,
21,
31,
28,
07,
04,

2001
2005
2006
2009
2009
2002
2001
2001
2005
2010

10MG
20MG

N020325
N020325

001
002

Apr 28, 1995

Sep 23, 2003

10MG

N020902

001

Aug 05, 1999

N201373

001

Jan 24, 2011

N201373

002

Jan 24, 2011

N021909

002

Jan 24, 2011

N021909

003

Jan 24, 2011

N020872
N020872

007
010

Jan 24, 2011

Jan 24, 2011

N020872
N020872

008
009

Jan 24, 2011

Jan 24, 2011

N020872

005

Jan 24, 2011

N020872

006

Jan 24, 2011

A076502
A077081
A076447

004
004
004

Apr 12, 2011

Jul 21, 2011
Apr 13, 2011

A076502
A077081
A076447

005
005
005

Apr 12, 2011

Jul 21, 2011
Apr 13, 2011

A076502
A076502
A077081
A077081
A076447
A076447

006
008
006
008
006
008

Apr
Apr
Jul
Jul
Apr
Apr

12,
12,
21,
21,
13,
13,

2011
2011
2011
2011
2011
2011

A076502
A076502
A077081
A077081
A076447
A076447

007
009
007
009
007
009

Apr
Apr
Jul
Jul
Apr
Apr

12,
12,
21,
21,
13,
13,

2011
2011
2011
2011
2011
2011

FEXOFENADINE HYDROCHLORIDE
SUSPENSION; ORAL

CHILDREN'S ALLEGRA ALLERGY

+ SANOFI AVENTIS US
30MG/5ML
CHILDREN'S ALLEGRA HIVES
+ SANOFI AVENTIS US
30MG/5ML
TABLET, ORALLY DISINTEGRATING; ORAL

CHILDREN'S ALLEGRA ALLERGY

+ SANOFI AVENTIS US
30MG
CHILDREN'S ALLEGRA HIVES
+ SANOFI AVENTIS US
30MG
TABLET; ORAL
ALLEGRA ALLERGY
SANOFI AVENTIS US
60MG
+
180MG
ALLEGRA HIVES
SANOFI AVENTIS US
60MG
+
180MG
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
MYLAN
30MG
TEVA
30MG
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
DR REDDYS LABS LTD
30MG
MYLAN
30MG
TEVA
30MG
FEXOFENADINE HYDROCHLORIDE ALLERGY
DR REDDYS LABS LTD
60MG
180MG
MYLAN
60MG
180MG
TEVA
60MG
180MG
FEXOFENADINE HYDROCHLORIDE HIVES
DR REDDYS LABS LTD
60MG
180MG
MYLAN
60MG
180MG
TEVA
60MG
180MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 9 (of 19)

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
180MG;240MG

N020786

002

Jan 24, 2011

N021704

002

Jan 24, 2011

A079043

002

Jun 22, 2011

600MG

A078912

001

Nov 23, 2011

600MG
1.2GM

N021282
N021282

001
002

Jul 12, 2002

Dec 18, 2002

N021585
N021585

001
002

Jun 22, 2004

Jun 22, 2004

ACID AND POTASSIUM SALT

N020402

001

Apr 20, 1995

ACID AND POTASSIUM SALT

N020402

002

Mar 16, 2000

ACID AND POTASSIUM SALT

ACID AND POTASSIUM SALT

A202300
A078682
A074782
A077338
A079205

001
001
001
001
001

Dec
Mar
Jul
Jul
Jun

N021472

001

Oct 18, 2002

N020603

001

Jun 10, 1996

A075217
A079058

001
001

Dec 16, 1998

Aug 31, 2009

N020812

001

Jan 30, 1998

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
A200457

001
001

Apr 30, 1999

Aug 18, 2011

N020944

001

Dec 18, 1998

N020601

001

Nov 15, 1996

GUAIFENESIN
TABLET, EXTENDED RELEASE;
GUAIFENESIN
PERRIGO R AND D
MUCINEX
RECKITT BENCKISER
+

ORAL

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL
MUCINEX D
RECKITT BENCKISER
600MG;60MG
+
1.2GM;120MG

IBUPROFEN
CAPSULE; ORAL

ADVIL LIQUI-GELS

+ WYETH CONS
EQ 200MG FREE
ADVIL MIGRAINE LIQUI-GELS
+ WYETH CONS
EQ 200MG FREE
IBUPROFEN
AMNEAL PHARMS
EQ 200MG FREE
BANNER PHARMACAPS
EQ 200MG FREE
+ CONTRACT PHARMACAL
200MG
DR REDDYS LABS LTD
EQ 200MG FREE
MARKSANS PHARMA
EQ 200MG FREE
MIDOL LIQUID GELS
+ BANNER PHARMACAPS
200MG
SUSPENSION/DROPS; ORAL

CHILDREN'S MOTRIN

+ MCNEIL CONS
40MG/ML
IBUPROFEN
PERRIGO
40MG/ML
TRIS PHARMA INC
40MG/ML
PEDIATRIC ADVIL
+ WYETH CONS
100MG/2.5ML
SUSPENSION; ORAL
CHILDREN'S ADVIL
WYETH CONS
100MG/5ML
CHILDREN'S ADVIL-FLAVORED
WYETH CONS
100MG/5ML
CHILDREN'S ELIXSURE
ALTERNA TCHP LLC
100MG/5ML
CHILDREN'S IBUPROFEN
PERRIGO
100MG/5ML
CHILDREN'S MOTRIN
+ MCNEIL
100MG/5ML
IBUPROFEN
ACTAVIS MID ATLANTIC 100MG/5ML
AMNEAL PHARMS
100MG/5ML
TABLET, CHEWABLE; ORAL
CHILDREN'S ADVIL
WYETH CONS
50MG
CHILDREN'S MOTRIN
MCNEIL CONS
50MG

ACID AND POTASSIUM SALT

ACID AND POTASSIUM SALT

23,
24,
06,
10,
26,

2011
2009
1998
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 10 (of 19)

IBUPROFEN
TABLET, CHEWABLE; ORAL
IBUPROFEN
PERRIGO
JUNIOR STRENGTH ADVIL
WYETH CONS
JUNIOR STRENGTH MOTRIN
+ MCNEIL CONS
TABLET; ORAL
ADVIL
WYETH CONS
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

50MG
100MG

A076359
A076359

001
002

Jan 16, 2004

Jan 16, 2004

100MG

N020944

002

Dec 18, 1998

100MG

N020601

003

Nov 15, 1996

200MG

N018989

001

May 18, 1984

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

A071333
A072199
A076460
A071732
A071735
A072299
A073691
A074931
A075661
A076117
A079174
A076741
A075010
A075139
A091237
A091239
A073019
A070985
A071163
A070481
A072096
A075995
A077349
A079129
A091355
A071229
A071639
A070435

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Feb
May
Nov
Sep
Sep
Jul
Feb
Jul
Dec
Nov
Dec
Jun
Mar
Mar
Feb
Feb
Mar
Oct
Jul
Sep
Dec
Mar
Jun
Mar
Apr
Apr
Feb
Mar

A071214

001

Dec 01, 1986

A071057

001

Aug 11, 1988

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

N022565

001

May 27, 2010

WATSON LABS
IBUPROHM
OHM LABS
200MG
IBU-TAB 200
ALRA
200MG
JUNIOR STRENGTH ADVIL
WYETH CONS
100MG
JUNIOR STRENGTH IBUPROFEN
PERRIGO
100MG
JUNIOR STRENGTH MOTRIN
MCNEIL CONS
100MG
MOTRIN IB
+ MCNEIL
200MG
MOTRIN MIGRAINE PAIN
+ MCNEIL
200MG
PROFEN
CONTRACT PHARMACAL
200MG
TAB-PROFEN
PERRIGO
200MG

17,
23,
26,
10,
10,
01,
25,
20,
12,
20,
10,
17,
01,
01,
08,
01,
30,
02,
15,
24,
08,
14,
21,
28,
04,
01,
02,
05,

1987
1988
2003
1987
1987
1988
1994
1998
2001
2001
2010
2004
1999
1999
2011
2011
1994
1987
1986
1986
1987
2002
2005
2011
2011
1987
1988
1986

IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

TABLET; ORAL

ADVIL CONGESTION RELIEF

+ WYETH CONS
200MG;10MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 11 (of 19)

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

CAPSULE; ORAL

ADVIL COLD AND SINUS

+ WYETH CONS

EQ 200MG FREE ACID AND POTASSIUM

SALT;30MG

N021374

001

May 30, 2002

N021373

001

Apr 18, 2002

N021128

001

Aug 01, 2000

A076478

001

Nov 05, 2003

N019771

001

Sep 19, 1989

A075588
A077628

001
001

Apr 08, 2002

Aug 14, 2006

A074567

001

Apr 17, 2001

N019899

001

Dec 31, 1992

100 UNITS/ML

N018780

001

Oct 28, 1982

100 UNITS/ML

N018780

005

Aug 06, 1998

100 UNITS/ML

N019938

001

Jun 25, 1991

SUSPENSION; ORAL
CHILDREN'S ADVIL COLD
WYETH CONS
100MG/5ML;15MG/5ML
CHILDREN'S MOTRIN COLD
+ MCNEIL CONS
100MG/5ML;15MG/5ML
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
PERRIGO
100MG/5ML;15MG/5ML
TABLET; ORAL

ADVIL COLD AND SINUS

+ WYETH CONS
200MG;30MG
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
CONTRACT PHARMACAL
200MG;30MG
DR REDDYS LABS LTD
200MG;30MG
IBUPROHM COLD AND SINUS
OHM LABS
200MG;30MG
SINE-AID IB
MCNEIL CONS
200MG;30MG

INSULIN RECOMBINANT HUMAN

INJECTABLE; INJECTION

HUMULIN R

+ LILLY
HUMULIN R PEN
+ LILLY
NOVOLIN R
+ NOVO NORDISK INC

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

INJECTABLE; INJECTION

HUMULIN 70/30

+ LILLY
HUMULIN 70/30 PEN
+ LILLY
NOVOLIN 70/30
+ NOVO NORDISK INC

30 UNITS/ML;70 UNITS/ML

N019717

001

Apr 25, 1989

30 UNITS/ML;70 UNITS/ML

N019717

002

Aug 06, 1998

30 UNITS/ML;70 UNITS/ML

N019991

001

Jun 25, 1991

100 UNITS/ML

N018781

001

Oct 28, 1982

100 UNITS/ML

N019959

001

Jul 01, 1991

EQ 0.7% IODINE;74% (6ML)

EQ 0.7% IODINE;74% (26ML)

N021586
N021586

001
002

Sep 29, 2006

Sep 29, 2006

1%

N020310

001

Oct 10, 1997

12.5MG

N022470

001

Nov 25, 2009

INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

INJECTABLE; INJECTION

HUMULIN N

+ LILLY
NOVOLIN N
+ NOVO NORDISK INC

IODINE POVACRYLEX; ISOPROPYL ALCOHOL

SPONGE; TOPICAL

DURAPREP

+ 3M
+

KETOCONAZOLE
SHAMPOO; TOPICAL

NIZORAL A-D

+ MCNEIL CONS

KETOPROFEN
FILM; ORAL

NEXCEDE

+ NOVARTIS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 12 (of 19)

KETOTIFEN FUMARATE
SOLUTION/DROPS; OPHTHALMIC

ALAWAY

+ BAUSCH AND LOMB

EQ
KETOTIFEN FUMARATE
AKORN
EQ
ALCON PHARMS LTD
EQ
APOTEX INC
EQ
ZADITOR
+ ALCON PHARMA
EQ

0.025% BASE

N021996

001

Dec 01, 2006

0.025% BASE
0.025% BASE
0.025% BASE

A077958
A077200
A077354

001
001
001

Jul 26, 2007

Sep 02, 2008
May 09, 2006

0.025% BASE

N021066

002

Oct 19, 2006

N022327

001

May 18, 2009

0.75MG
0.75MG

A090740
A078665

001
001

Dec 30, 2010

Aug 28, 2009

0.75MG

N021045

002

Aug 24, 2006

1.5MG

N021998

001

Jul 10, 2009

N021855
N021855

001
002

Aug 04, 2005

Aug 04, 2005

N019487

001

Mar 01, 1988

A074352
A073243
A073079
A074730

001
001
001
001

Nov
Jan
Apr
Aug

N019487

002

Jul 08, 2004

A091292

001

May 20, 2011

N020448

001

Jul 24, 1997

N019860

001

Nov 22, 1989

A073254
A076497
A074091
A075232

001
001
001
001

Jul
Jun
Dec
Jan

N020606

001

Jun 26, 1996

A076029

001

Aug 30, 2002

LANSOPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL

PREVACID 24 HR

+ NOVARTIS
15MG

LEVONORGESTREL
TABLET; ORAL
LEVONORGESTREL
PERRIGO R AND D
+ WATSON LABS
PLAN B
+ TEVA WOMENS
PLAN B ONE-STEP
+ DURAMED

LOPERAMIDE HYDROCHLORIDE
CAPSULE; ORAL
LOPERAMIDE HYDROCHLORIDE
BANNER PHARMACAPS
1MG
+
2MG
SOLUTION; ORAL

IMODIUM A-D

+ MCNEIL CONS
1MG/5ML
LOPERAMIDE HYDROCHLORIDE
HI TECH PHARMA
1MG/5ML
PERRIGO
1MG/5ML
ROXANE
1MG/5ML
WOCKHARDT
1MG/5ML
SUSPENSION; ORAL

IMODIUM A-D

+ MCNEIL CONS
1MG/7.5ML
LOPERAMIDE HYDROCHLORIDE
PERRIGO R AND D
1MG/7.5ML
TABLET, CHEWABLE; ORAL

IMODIUM A-D EZ CHEWS

+ MCNEIL
2MG
TABLET; ORAL

IMODIUM A-D

+ MCNEIL CONS
2MG
LOPERAMIDE HYDROCHLORIDE
CONTRACT PHARMACAL
2MG
LNK
2MG
OHM LABS
2MG
PERRIGO
2MG

17,
21,
30,
28,

30,
10,
10,
06,

1995
1992
1992
1997

1993
2003
1992
2000

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

TABLET, CHEWABLE; ORAL

IMODIUM MULTI-SYMPTOM RELIEF

+ MCNEIL
2MG;125MG
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
PERRIGO
2MG;125MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 13 (of 19)

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

TABLET; ORAL

IMODIUM MULTI-SYMPTOM RELIEF

+ MCNEIL CONS
2MG;125MG
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
RANBAXY
2MG;125MG

N021140

001

Nov 30, 2000

A077500

001

Sep 06, 2006

N021952

001

Jun 16, 2008

N021734

001

Oct 04, 2005

N020641

002

Nov 27, 2002

A075565
A075728
A076529
A077421
A076805
A075505
A075815

001
001
001
001
001
001
001

Oct
Aug
Aug
Jun
Aug
Nov
Aug

N021891

001

Aug 23, 2006

N021375

001

Dec 19, 2002

N020704

003

Nov 19, 2003

N021993
N020704

001
002

Dec 12, 2006

Nov 27, 2002

A076011
A075990
A075822

001
001
001

Sep 29, 2003

Nov 03, 2003
Feb 10, 2003

A077153

001

Apr 11, 2007

N019658

002

Nov 27, 2002

N019658

003

Nov 19, 2003

A076471
A075790
A076154
A078447
A076301
A076134
A075209

001
001
001
001
001
001
001

Feb
Nov
Aug
Aug
Jun
Aug
Jan

N019670

002

Nov 27, 2002

N020470

002

Nov 27, 2002

A076050
A075989

001
001

Jan 30, 2003

Mar 04, 2004

LORATADINE
CAPSULE; ORAL

CLARITIN

+ SCHERING PLOUGH
10MG
SUSPENSION; ORAL

LORATADINE

+ TARO
1MG/ML
SYRUP; ORAL

CLARITIN

+ SCHERING PLOUGH
1MG/ML
LORATADINE
APOTEX INC
1MG/ML
PERRIGO
1MG/ML
RANBAXY
1MG/ML
SILARX
1MG/ML
TARO
1MG/ML
TEVA
1MG/ML
WOCKHARDT
1MG/ML
TABLET, CHEWABLE; ORAL

CHILDREN'S CLARITIN

+ SCHERING PLOUGH
5MG
TABLET, ORALLY DISINTEGRATING; ORAL
ALAVERT
WYETH CONS
10MG
CLARITIN HIVES RELIEF REDITAB
+ SCHERING PLOUGH
10MG
CLARITIN REDITABS
+ SCHERING PLOUGH
5MG
+
10MG
LORATADINE
IMPAX LABS
10MG
WATSON LABS FLORIDA
10MG
WYETH CONS
10MG
LORATADINE REDIDOSE
RANBAXY
10MG
TABLET; ORAL
CLARITIN
+ SCHERING PLOUGH
10MG
CLARITIN HIVES RELIEF
+ SCHERING PLOUGH
10MG
LORATADINE
APOTEX INC
10MG
MYLAN
10MG
10MG
10MG
PERRIGO
10MG
RANBAXY
10MG
SANDOZ
10MG

05,
20,
20,
29,
20,
07,
20,

14,
07,
20,
12,
25,
18,
21,

2004
2004
2004
2006
2004
2003
2004

2006
2008
2003
2011
2004
2003
2003

LORATADINE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE; ORAL

CLARITIN-D

+ SCHERING PLOUGH
5MG;120MG
CLARITIN-D 24 HOUR
+ SCHERING PLOUGH
10MG;240MG
LORATADINE AND PSEUDOEPHEDRINE SULFATE
IMPAX LABS
5MG;120MG
10MG;240MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 14 (of 19)

LORATADINE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE; ORAL
LORATADINE AND PSEUDOEPHEDRINE SULFATE
RANBAXY
10MG;240MG
WATSON LABS FLORIDA
5MG;120MG
10MG;240MG

A076557
A076208
A075706

001
001
001

Sep 22, 2004

Jan 28, 2004
Feb 21, 2003

N022029

001

Feb 20, 2008

A076585

001

Mar 26, 2004

A079114

001

Jun 02, 2010

A075329

001

Apr 20, 1999

N021308

001

Jun 29, 2001

N020288

002

Apr 26, 1993

N020670

002

Apr 16, 1996

A074926

001

Apr 16, 1999

A076357

001

Mar 30, 2004

N021261

003

Jun 17, 2003

N021261

001

Feb 02, 2001

A076773

001

Mar 02, 2005

A074164

001

Mar 29, 1996

A074366
A074760
A091366
A074444

001
001
001
001

Feb
May
Jan
Jan

N020827

001

Mar 30, 1998

N017450

002

Feb 15, 1991

A073507
A074414
A074395

001
001
001

Nov 19, 1993

Apr 30, 1997
Mar 20, 1997

N018520

002

Feb 15, 1991

5%

N021812

001

Jan 20, 2006

5%

A091344

001

Apr 28, 2011

MENTHOL; METHYL SALICYLATE

PATCH; TOPICAL

SALONPAS

+ HISAMITSU

3%;10%

MICONAZOLE NITRATE
CREAM, SUPPOSITORY; TOPICAL, VAGINAL
MICONAZOLE 7 COMBINATION PACK
G AND W LABS
2%,100MG
MICONAZOLE NITRATE
PERRIGO R AND D
2%,1.2GM
MICONAZOLE NITRATE COMBINATION PACK
PERRIGO
2%,200MG
MONISTAT 1 COMBINATION PACK
+ INSIGHT PHARMS
2%,1.2GM
MONISTAT 7 COMBINATION PACK
+ INSIGHT PHARMS
2%,100MG
MONISTAT-3 COMBINATION PACK
+ INSIGHT PHARMS
2%,200MG
M-ZOLE 3 COMBINATION PACK
ACTAVIS MID ATLANTIC 2%,200MG
CREAM; TOPICAL, VAGINAL
MICONAZOLE 3 COMBINATION PACK
PERRIGO
2%,4%
MONISTAT 3 COMBINATION PACK
INSIGHT PHARMS
2%,4%
MONISTAT 3 COMBINATION PACK (PREFILLED)
+ INSIGHT PHARMS
2%,4%
CREAM; VAGINAL
MICONAZOLE 3
TARO
4%
MICONAZOLE 7
ACTAVIS MID ATLANTIC 2%
MICONAZOLE NITRATE
G AND W LABS
2%
PERRIGO
2%
PERRIGO R AND D
4%
TARO
2%
MONISTAT 3
+ INSIGHT PHARMS
4%
MONISTAT 7
+ INSIGHT PHARMS
2%
SUPPOSITORY; VAGINAL
MICONAZOLE NITRATE
ACTAVIS MID ATLANTIC 100MG
G AND W LABS
100MG
+ PERRIGO
100MG
MONISTAT 7
+ INSIGHT PHARMS
100MG

22,
15,
15,
13,

1996
1997
2010
1997

MINOXIDIL
AEROSOL, FOAM; TOPICAL

MEN'S ROGAINE

+ JOHNSON AND JOHNSON

MINOXIDIL
PERRIGO ISRAEL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 15 (of 19)

MINOXIDIL
SOLUTION; TOPICAL
MINOXIDIL (FOR MEN)
ACTAVIS MID ATLANTIC 2%
HI TECH PHARMA
2%
NOVEX
2%
PERRIGO
2%
WOCKHARDT
2%
MINOXIDIL (FOR WOMEN)
HI TECH PHARMA
2%
NOVEX
2%
PERRIGO
2%
MINOXIDIL EXTRA STRENGTH (FOR MEN)
ACTAVIS MID ATLANTIC 5%
AVACOR PRODS
5%
NOVEX
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
EI INC
2%
5%

A074588
A074731
A074924
A075357
A074767

001
001
001
001
001

Apr
Dec
Apr
Jul
Feb

05,
24,
29,
30,
28,

A074731
A074924
A075357

002
002
002

May 11, 2005

Apr 29, 1998
Jul 30, 1999

A075518
A075619
A075839
A075598
A075737
A075438

001
001
001
001
001
001

Nov
Nov
Oct
Jun
Mar
Feb

N019501

002

Feb 09, 1996

N019501

003

Feb 09, 1996

N020834

001

Nov 14, 1997

A078176
A076239

001
001

Nov 09, 2007

Aug 24, 2004

A078208

001

Sep 27, 2010

N020226

001

Jun 08, 1994

N020065

001

Jun 08, 1994

N020485

001

Jan 31, 1996

EQ 200MG BASE

N021920

001

Feb 17, 2006

EQ 200MG BASE

N020204

002

Jan 11, 1994

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A079096
A074635
A074789
A075168
A091353
A090545
A074661
A091183
A074646

001
001
001
001
001
001
001
001
001

Dec
Jan
Feb
Jul
Sep
Mar
Jan
May
Jan

N021076

001

Nov 29, 1999

A077381

001

Sep 27, 2006

17,
17,
01,
13,
15,
27,

1996
1996
1998
1999
1997

2000
2000
2001
2001
2002
2003

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

SOLUTION/DROPS; OPHTHALMIC
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
ALTAIRE PHARMS INC
0.02675%;0.315%
NAPHCON-A
+ ALCON
0.025%;0.3%
OPCON-A
+ BAUSCH AND LOMB
0.02675%;0.315%
VISINE-A
+ JOHNSON AND JOHNSON
0.025%;0.3%

NAPROXEN SODIUM
CAPSULE; ORAL

NAPROXEN SODIUM

+ BANNER PHARMACAPS
TABLET; ORAL

ALEVE

+ BAYER
NAPROXEN SODIUM
AMNEAL PHARMS NY
CONTRACT PHARMACAL
DR REDDYS LABS INC
GRANULES INDIA
MARKSANS PHARMA
PERRIGO
RANBAXY LABS LTD
SANDOZ

200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

16,
13,
27,
28,
20,
16,
13,
20,
13,

2008
1997
1997
1998
2011
2011
1997
2011
1997

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL

ALEVE-D SINUS & COLD

+ BAYER
200MG;120MG
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
DR REDDYS LABS INC
EQ 220MG BASE;120MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 16 (of 19)

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
PERRIGO
EQ 200MG BASE;120MG

A076518

001

Mar 17, 2004

N020076
N020076
N020076

004
005
006

Nov 12, 1999

Nov 12, 1999
Nov 12, 1999

N020165
N020165
N020165

006
005
004

Aug 02, 1996

Aug 02, 1996
Aug 02, 1996

A074645
A074611
A074612

001
001
001

Oct 20, 1997

Oct 20, 1997
Oct 20, 1997

BASE
BASE
BASE
BASE

N018612
N018612
N020066
N020066

002
004
002
004

Feb
Sep
Feb
Sep

EQ 2MG BASE
EQ 4MG BASE

N018612
N020066

003
003

Dec 23, 1998

Dec 23, 1998

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A076880
A077850
A076775
A076776
A076777
A076778
A076779
A076789
A078325
A078547
A078967
A091349
A078326
A078546
A078968
A091354
A074507
A076569
A078699
A079044
A079216
A074707
A076568
A078697
A079038
A079219

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001

Feb
Feb
Sep
Sep
Sep
Sep
Sep
Sep
Oct
May
Apr
Jul
Oct
May
Apr
Jul
Mar
Jul
Dec
Jul
Jul
Mar
Jul
Dec
Jul
Jul

EQ 2MG BASE
EQ 4MG BASE

A077658
A077656

001
001

Jun 19, 2007

Jun 19, 2007

EQ 2MG BASE
EQ 4MG BASE

N021330
N021330

001
002

Oct 31, 2002

Oct 31, 2002

NICOTINE
FILM, EXTENDED RELEASE; TRANSDERMAL

HABITROL

+ NOVARTIS
7MG/24HR
+
14MG/24HR
+
21MG/24HR
NICODERM CQ
+ SANOFI AVENTIS US
7MG/24HR
+
14MG/24HR
+
21MG/24HR
NICOTINE
AVEVA
7MG/24HR
14MG/24HR
21MG/24HR

NICOTINE POLACRILEX
GUM, CHEWING; BUCCAL

NICORETTE

+ GLAXOSMITHKLINE
+
NICORETTE (MINT)
GLAXOSMITHKLINE
NICOTINE POLACRILEX
IVAX SUB TEVA PHARMS
PERRIGO

PERRIGO R AND D

WATSON LABS

THRIVE
NOVARTIS
TROCHE/LOZENGE; ORAL
COMMIT
GLAXOSMITHKLINE CONS
+

EQ
EQ
EQ
EQ

2MG
2MG
4MG
4MG

2MG
4MG
2MG
2MG
2MG
4MG
4MG
4MG
2MG
2MG
2MG
2MG
4MG
4MG
4MG
4MG
2MG
2MG
2MG
2MG
2MG
4MG
4MG
4MG
4MG
4MG

09,
25,
09,
25,

18,
18,
16,
16,
16,
16,
16,
16,
30,
24,
23,
20,
30,
24,
23,
20,
15,
29,
29,
08,
08,
19,
29,
29,
08,
08,

1996
2000
1996
2000

2009
2009
2004
2004
2004
2004
2004
2004
2006
2007
2008
2011
2006
2007
2008
2011
1999
2004
2008
2009
2009
1999
2004
2008
2009
2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 17 (of 19)

NICOTINE POLACRILEX
TROCHE/LOZENGE; ORAL
NICORETTE
GLAXOSMITHKLINE CONS
+
NICOTINE POLACRILEX
PERRIGO R AND D

EQ 2MG BASE
EQ 4MG BASE

N022360
N022360

001
002

May 18, 2009

May 18, 2009

EQ
EQ
EQ
EQ
EQ
EQ

A077007
A090711
A090821
A077007
A090711
A090821

001
001
001
002
002
002

Jan
Jul
Jul
Jan
Jul
Jul

75MG

N020555

001

May 09, 1996

1GM

N018683

001

Apr 01, 1983

N022032

001

Dec 04, 2007

A078878

001

Jun 05, 2009

N021229

001

Jun 20, 2003

20MG;1.1GM

N022281

001

Dec 01, 2009

60MG

N021887

001

Feb 07, 2007

N018471

001

May 30, 1986

N019407

001

Mar 31, 1989

1%

N019918

001

May 02, 1990

1%
1%

A075014
A076090

001
001

Mar 28, 2000

Dec 20, 2001

2MG
2MG
2MG
4MG
4MG
4MG

BASE
BASE
BASE
BASE
BASE
BASE

31,
10,
10,
31,
10,
10,

2006
2009
2009
2006
2009
2009

NIZATIDINE
TABLET; ORAL

AXID AR

+ WYETH CONS

NONOXYNOL-9
SPONGE; VAGINAL

TODAY

+ AZTIQ PHARMA

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

ORLISTAT
CAPSULE; ORAL

ALLI

+ GLAXOSMITHKLINE CONS

OXYMETAZOLINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
OCUCLEAR
SCHERING PLOUGH
0.025%
VISINE L.R.
+ JOHNSON AND JOHNSON
0.025%

PERMETHRIN
LOTION; TOPICAL

NIX

+ INSIGHT PHARMS
PERMETHRIN
ACTAVIS MID ATLANTIC
PERRIGO NEW YORK

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 18 (of 19)

PIPERONYL BUTOXIDE; PYRETHRINS

AEROSOL; TOPICAL

RID MOUSSE

+ BAYER HLTHCARE

4%;EQ 0.33% BASE

N021043

001

Mar 07, 2000

17GM/PACKET
17GM/SCOOPFUL

A090600
A090600

001
002

Oct 06, 2009

Oct 06, 2009

N022015

001

Oct 06, 2006

A078915
A078915
A090812
A091077
A090567
A090685
A090685

001
002
001
001
001
001
002

Oct
Oct
Oct
Oct
Oct
Oct
Oct

65MG/ML

A077218

001

Jan 12, 2005

65MG
130MG

N018664
N018664

002
001

May 12, 2011

Oct 14, 1982

65MG

A076350

001

Sep 10, 2002

1%

N019522

001

Mar 31, 1989

20%

N019240

001

Nov 29, 1985

10%

N019476

001

Jan 07, 1987

A075153
A077442

001
001

Feb 26, 1999

Sep 28, 2005

A073585

001

Oct 31, 1991

N020021

002

Dec 15, 1992

N018191

001

N022305

001

POLYETHYLENE GLYCOL 3350

FOR SOLUTION; ORAL
GLYCOLAX
KREMERS URBAN PHARMS

MIRALAX
+ SCHERING PLOUGH
17GM/SCOOPFUL
POLYETHYLENE GLYCOL 3350
MYLAN
17GM/PACKET
17GM/SCOOPFUL
NEXGEN PHARMA
17GM/SCOOPFUL
NOVEL LABS INC
17GM/SCOOPFUL
PADDOCK LLC
17GM/SCOOPFUL
PERRIGO R AND D
17GM/PACKET
17GM/SCOOPFUL

06,
06,
07,
06,
15,
06,
06,

2009
2009
2009
2009
2009
2009
2009

POTASSIUM IODIDE
SOLUTION; ORAL

THYROSHIELD

+ FLEMING
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
PSEUDOEPHEDRINE HYDROCHLORIDE
PERRIGO
120MG
RANBAXY
120MG
SUDAFED 12 HOUR
+ MCNEIL CONS
120MG
SUDAFED 24 HOUR
+ MCNEIL CONS
240MG

PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE; ORAL

AFRINOL

+ SCHERING PLOUGH
120MG

PURIFIED WATER
SOLUTION; OPHTHALMIC

PUR-WASH

+ NIAGARA PHARMS

98.3%

Sep 01, 2011

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

OTC DRUG PRODUCT LIST

4 - 19 (of 19)

RANITIDINE HYDROCHLORIDE
TABLET; ORAL
RANITIDINE HYDROCHLORIDE
CONTRACT PHARMACAL
EQ
DR REDDYS LABS LTD
EQ
EQ
IVAX SUB TEVA PHARMS EQ
MYLAN
EQ
PERRIGO
EQ
PERRIGO R AND D
EQ
EQ
SVADS HOLDINGS SA
EQ
TORPHARM
EQ
WATSON LABS
EQ
WOCKHARDT
EQ
EQ
EQ
ZANTAC 150
+ BOEHRINGER INGELHEIM EQ
EQ
ZANTAC 75
BOEHRINGER INGELHEIM EQ

75MG BASE
75MG BASE
150MG BASE
75MG BASE
75MG BASE
75MG BASE
150MG BASE
150MG BASE
150MG BASE
75MG BASE
75MG BASE
75MG BASE
75MG BASE
150MG BASE

A075094
A075294
A078192
A075296
A075497
A076195
A091429
A091429
A200536
A075167
A075212
A076760
A078884
A078653

001
001
001
001
001
001
001
002
001
001
001
001
001
001

Jun
Mar
Aug
Jan
Jan
Aug
May
May
Jun
May
Jan
Feb
Jul
Nov

21,
28,
31,
14,
14,
30,
11,
11,
28,
04,
14,
24,
31,
26,

1999
2000
2007
2000
2000
2002
2011
2011
2011
2000
2000
2006
2008
2007

150MG BASE
150MG BASE

N021698
N021698

001
002

Aug 31, 2004

Mar 13, 2007

75MG BASE

N020520

001

Dec 19, 1995

N019912

001

Sep 03, 1992

0.24%;0.3%

N020231

001

Jul 11, 1997

1%

N021958

001

Jul 24, 2006

N020980

001

Mar 09, 1999

A077511

001

Jul 02, 2007

N021124

001

Mar 17, 2000

N021124

002

Mar 17, 2000

6.5%

A075915

001

Nov 21, 2001

6.5%

N020676

001

Feb 11, 1997

SODIUM CHLORIDE
AEROSOL, METERED; INHALATION

BRONCHO SALINE

+ BLAIREX
0.9%

SODIUM FLUORIDE; TRICLOSAN

PASTE; DENTAL

COLGATE TOTAL

+ COLGATE PALMOLIVE

TERBINAFINE
GEL; TOPICAL

LAMISIL AT

+ NOVARTIS

TERBINAFINE HYDROCHLORIDE
CREAM; TOPICAL

LAMISIL

+ NOVARTIS
1%
TERBINAFINE HYDROCHLORIDE
TARO
1%
SOLUTION; TOPICAL

LAMISIL AT

+ NOVARTIS
1%
SPRAY; TOPICAL

LAMISIL AT

+ NOVARTIS
1%

TIOCONAZOLE
OINTMENT; VAGINAL
TIOCONAZOLE
PERRIGO
VAGISTAT-1
+ NOVARTIS

32nd EDITION - 2012- APPROVED DRUG PRODUCT LIST

5 - 1 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT 4% SODIUM CITRATE SOLUTION USP

INJECTABLE; INJECTION
NONE
MEDSEP CORPORATION

N760305

Jun 30, 1978

N020037

Aug 26, 2003

ANTICOAGULANT CITRATE DEXTROSE SOLUTION (ACD)

INJECTABLE; INJECTION
CITRA LABS LLC
ACD-A SOLUTION
GAMBRO BCT INC
ADSOL WITH ACD-A
FENWAL INC
ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A
HAEMONETICS CORP
AS3 SOLUTION/ACD-A
GAMBRO BCT INC

A010228

ANDA

N000922
A980728

Feb 25, 2002

Aug 29, 2002

ANDA

Feb 06, 2002

N001214

May 29, 2002

N100855
N160918
N110912

Jun 03, 1959

Mar 17, 1978
Sep 02, 1959

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP

INJECTABLE; INJECTION
NONE
FENWAL INC
FRESENIUS MEDICAL
CARE NORTH AMERICA
MEDSEP CORPORATION
MILES INC

A710497
N100102

ANDA
Dec 14, 1961

ANTICOAGULANT CITRATE PHOSPHATE 2X DEXTROSE SOLUTION (CP2D)

INJECTABLE; INJECTION
CITRATE PHOSPHATE DOUBLE DEXTROSE/ADDITIVE SOLUTION 3
HAEMONETICS CORP

N000127

Jan 18, 2002

N780519

Apr 23, 1980

N820528

Nov 03, 1982

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION

INJECTABLE; INJECTION
NONE
FRESENIUS MEDICAL
CARE NORTH AMERICA
TERUMO MEDICAL CORP

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION (CPDA)

INJECTABLE; INJECTION
CPDA-1 BLOOD-PACK UNIT (PL 146 PLASTIC) 250, 450, 500 ML BLOOD PACK UNITS
FENWAL INC
N770420

May 12, 1978

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION USP

INJECTABLE; INJECTION
BLOOD PACK UNIT CPDA-1 IN PLASTIC CONTAINER
FENWAL INC

N940404

Jul 28, 1994

N800077

Nov 06, 1980

N900223

Dec 27, 1991

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE-1 SOLUTION

INJECTABLE; INJECTION
NONE
MEDSEP CORPORATION

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION

INJECTABLE; INJECTION
ADSOL IN PLASTIC CONTAINER
FENWAL INC

32nd EDITION - 2012- APPROVED DRUG PRODUCT LIST

5 - 2 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION (CPD)

INJECTABLE; INJECTION
MACOPRODUCTIONS SAS CPD/AS-1: MACOPHARMA LEUCOFLEX MTL1 LEUKOREDUCTION SYSTEM FOR BLOOD
COMPONENTS KNOWN AS MTL1-WB
MACOPRODUCTIONS SAS
N040083
Nov 21, 2005
NONE
GAMBRO BCT INC
A070025
Jan 06, 2008

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP

INJECTABLE; INJECTION
NONE
FENWAL INC
FRESENIUS MEDICAL
CARE NORTH AMERICA
MEDSEP CORPORATION
MILES INC
TERUMO MEDICAL CORP

N170401
N811012
N160907

Dec 06, 1977

Jun 28, 1983
May 16, 1973

N800222
N160527
N781211

Aug 23, 1982

Jun 22, 1970
Jun 10, 1981

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-1:

DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION
ADSOL RED BLOOD CELL PRESERVATIVE SOLUTION
FENWAL INC

N811104

May 16, 1983

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-5:

DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION
OPTISOL RED BLOOD CELL PRESERVATIVE SOLUTION
TERUMO MEDICAL CORP

N880217

Oct 07, 1988

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:

AS-3: CITRIC ACID USP; MONOBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;

DEXTROSE USP; SODIUM CITRATE USP

INJECTABLE; INJECTION
AS-3 NUTRICEL ADDITIVE SYSTEM
MEDSEP CORP
0.042GM/100ML;0.276GM/100ML;
0.410GM/100ML;0.30GM/100ML;
1.10GM/100ML;0.588GM/100ML

N820915

Oct 19, 1984

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:

AS-2: CITRIC ACID USP; DIBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;

DEXTROSE USP; SODIUM CITRATE USP

INJECTABLE; INJECTION
AS-2 NUTRICEL ADDITIVE SYSTEM
MEDSEP CORP
0.042GM/100ML;0.285GM/100ML;
0.718GM/100ML;0.017GM/100ML;
0.396GM/100ML;0.588GM/100ML

N820915

Sep 22, 1983

N090480

Mar 07, 1955

N770822

May 17, 1978

ANTICOAGULANT ETHYLENEDIAMINE TETRAACETIC ACID (EDTA)

INJECTABLE; INJECTION
NONE
FENWAL INC

ANTICOAGULANT HEPARIN SOLUTION USP

INJECTABLE; INJECTION
NONE
FRESENIUS MEDICAL
CARE NORTH AMERICA

32nd EDITION - 2012- APPROVED DRUG PRODUCT LIST

5 - 3 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT SODIUM CITRATE 4% SOLUTION

INJECTABLE; INJECTION
NONE
HAEMONETICS
CORPORATION

N980123

Mar 03, 2000

N010409

Jul 10, 2003

N770923
N160702

Jan 20, 1978

Dec 28, 1970

N781214

Feb 08, 1980

N830715

Oct 30, 1984

N840619

Feb 22, 1985

ANTICOAGULANT SODIUM CITRATE SOLUTION

INJECTABLE; INJECTION
TRICITRASOL
CYTOSOL
LABORATORIES INC

ANTICOAGULANT SODIUM CITRATE SOLUTION USP

INJECTABLE; INJECTION
NONE
FENWAL INC
FRESENIUS MEDICAL
CARE NORTH AMERICA
TERUMO MEDICAL CORP

DEXTRAN 1 IN SODIUM CHLORIDE 0.6%

INJECTABLE; INJECTION
PROMIT
MEDA AB

DEXTRAN 40, 10% IN DEXTROSE 5%

INJECTABLE; INJECTION
GENTRAN 40
BAXTER HLTHCARE CORP 10GM/100ML;5GM/100ML
LMD IN PLASTIC CONTAINER
HOSPIRA INC
10GM/100ML;5GM/100ML
NONE
B BRAUN MEDICAL INC
10GM/100ML;5GM/100ML
HOSPIRA INC
10GM/100ML;5GM/100ML
MEDA AB
10GM/100ML;5GM/100ML
MILES INC
10GM/100ML;5GM/100ML
PHARMACHEM CORP
10GM/100ML;5GM/100ML

A720563

ANDA

Oct 30, 1992

N160767
N160375
N140716
N160653
N160836

Apr
Jul
Jan
Sep
Nov

06,
25,
18,
23,
14,

1970
1967
1967
1969
1972

N840620

Feb 22, 1985

DEXTRAN 40, 10% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION
GENTRAN 40
BAXTER HLTHCARE CORP 10GM/100ML;0.9GM/100ML
LMD IN PLASTIC CONTAINER
HOSPIRA INC
10GM/100ML;0.9GM/100ML
NONE
B BRAUN MEDICAL INC
10GM/100ML;0.9GM/100ML
HOSPIRA INC
10GM/100ML;0.9GM/100ML
MEDA AB
10GM/100ML;0.9GM/100ML
MILES INC
10GM/100ML;0.9GM/100ML
PHARMACHEM CORP
10GM/100ML;0.9GM/100ML

A720562

ANDA

Oct 30, 1992

N160767
N160375
N140716
N160653
N160836

Apr
Jul
Jan
Sep
Nov

06,
25,
18,
23,
14,

1970
1967
1967
1969
1972

N830527

Mar 27, 1985

DEXTRAN 40, 10% W/V DEXTRAN 40 IN 0.8% NACL 500 ML PVC BAGS
INJECTABLE; INJECTION
RHEOMACRODEX
MEDA AB

32nd EDITION - 2012- APPROVED DRUG PRODUCT LIST

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% W/V DEXTRAN 40 IN 5% DEXTROSE 500 ML PVC BAGS

INJECTABLE; INJECTION
RHEOMACRODEX
MEDA AB

N830627

Mar 27, 1985

N060826

Jun 08, 1954

N160607

Jan 26, 1970

6GM/100ML;5GM/100ML

N060826

Jun 08, 1954

6GM/100ML;0.9 GM/100ML
6GM/100ML;0.9 GM/100ML

N090024
N080716

Aug 18, 1969

Mar 13, 1953

N830613

Mar 27, 1985

N830629

Mar 27, 1985

N080564
N160759

Sep 19, 1952

Aug 19, 1970

N200952

Mar 31, 1999

DEXTRAN 70, 6% IN DEXTROSE 5%

INJECTABLE; INJECTION
MACRODEX
MEDA AB

6GM/100ML;5GM/100ML

DEXTRAN 70, 6% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION
GENTRAIN 70
BAXTER HLTHCARE CORP
MACRODEX
MEDA AB
NONE
B BRAUN MEDICAL INC
MILES INC

DEXTRAN 70, 6% W/V DEXTRAN 70 IN 0.9% NACL IN 500 ML PVC BAGS

INJECTABLE; INJECTION
MACRODEX
MEDA AB

DEXTRAN 70, 6% W/V DEXTRAN 70 IN 5% DEXTROSE

INJECTABLE; INJECTION
MACRODEX
MEDA AB

DEXTRAN 75, 6% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION
NONE
PHARMACHEM CORP

6GM/100ML;0.9GM/100ML
6GM/100ML;0.9GM/100ML

HETASTARCH 6% IN LACTATED ELECTROLYTE INJECTION

INJECTABLE; INJECTION
HEXTEND
BIOTIME INC

6GM/100ML

HETASTARCH 6% IN SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION
6% HETASTARCH IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA INC
6GM/100ML;0.9GM/100ML
HESPAN
B BRAUN MEDICAL INC
6GM/100ML;0.9GM/100ML
HESPAN IN PLASTIC CONTAINER
B BRAUN MEDICAL INC
6GM/100ML;0.9GM/100ML
NONE
B BRAUN MEDICAL INC
6GM/100ML;0.9GM/100ML
TEVA PARENTERAL
6GM/100ML;0.9GM/100ML
MEDICINES INC

A740193

ANDA

Jan 30, 1995

N160889

Jul 17, 1972

N890105

Apr 04, 1991

A740283
A740592

ANDA
ANDA

Oct 21, 1998

Nov 12, 1998

ANDA

Feb 07, 1996

HETASTARCH 6% IN SODIUM CHLORIDE 0.9% NACL 500 ML GLASS BOTTLES

INJECTABLE; INJECTION
NONE
HOSPIRA INC

6GM/100ML;0.9 GM/100ML

A720746

32nd EDITION - 2012- APPROVED DRUG PRODUCT LIST

5 - 5 of 5

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

HYDROXYETHYL STARCH 130/0.4 IN 6% SODIUM CHLORIDE 0.9%

INJECTABLE; INJECTION
VOLUVEN
FRESENIUS KABI
DEUTSCHLAND GMBH

6GM/100ML;0.9GM/100ML

N070012

NDA

Dec 27, 2007

PENTASTARCH 10% IN SODIUM CHLORIDE 0.9%

INJECTABLE;
PENTASPAN
B BRAUN
PENTASPAN
B BRAUN

INJECTION
MEDICAL INC
10GM/100ML;0.9GM/100ML
IN PLASTIC CONTAINER
MEDICAL INC
10GM/100ML;0.9GM/100ML

N841207

May 19, 1987

N890104

Apr 04, 1991

N860909

Dec 26, 1989

N950522

Feb 26, 1997

PERFLUORODECALIN; PERFLUOROTRI-N-PROPYLAMINE
INJECTABLE; INJECTION
FLUOSOL
ALPHA THERAPEUTIC
CORP

17.5GM/100ML;7.5GM/100ML

RED BLOOD CELL PROCESSING SOLUTION

INJECTABLE; INJECTION
REJUVESOL
CITRA LABS LLC

SODIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE,

DIABASIC ANHYDROUS; SODIUM PHOSPHATE MONOBASIC, MONOHYDRATE
INJECTABLE; INJECTION
INTERSOL SOLUTION
FENWAL INC.

2.26G/500ML; 2.21G/500ML; 1.59G/500ML;

1.53G/500ML; 0.465G/500ML

N080041

NDA

Dec 09, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 1 (of 346)

ABARELIX
INJECTABLE; INTRAMUSCULAR
PLENAXIS
SPECIALITY EUROPEAN
100MG/VIAL

N021320

001

Nov 25, 2003

100MG/ML

N017785

001

Mar 07, 1986

120MG

A072218

001

Mar 27, 1992

120MG
325MG
650MG
120MG
650MG

A073106
A073107
A073108
A071010
A071011

001
001
001
001
001

Feb
Feb
Feb
May
May

120MG
650MG
TABLET, EXTENDED RELEASE; ORAL
ACETAMINOPHEN
RANBAXY
650MG

N017756
N017756

002
001

A090205

001

Nov 18, 2009

A081095
A081096
A081097

001
001
001

Oct 26, 1990

Oct 26, 1990
Oct 26, 1990

A085640

001

A085639

001

A085638

001

A088889

001

Jan 16, 1986

A088991

001

Jun 28, 1985

A089405

001

May 15, 1990

A089268

001

Jul 02, 1987

A089568
A087550

001
001

Oct 05, 1988

Oct 19, 1984

A088944

001

Oct 17, 1985

A087628

001

Oct 01, 1986

A088743
A088765
A089067

001
001
001

Jul 18, 1985

Mar 27, 1985
Apr 19, 1985

ACETAMINOPHEN
INJECTABLE; INJECTION
INJECTAPAP
ORTHO MCNEIL PHARM
SUPPOSITORY; RECTAL
ACEPHEN
G AND W LABS
ACETAMINOPHEN
ABLE

ROXANE
TYLENOL
MCNEIL CONS

27,
27,
27,
12,
12,

1995
1995
1995
1987
1987

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

ACETAMINOPHEN; BUTALBITAL
CAPSULE; ORAL
BANCAP
FOREST PHARMS
325MG;50MG
BUCET
MALLINCKRODT
650MG;50MG
TENCON
MALLINCKRODT
650MG;50MG
TRIAPRIN
DUNHALL
325MG;50MG
TABLET; ORAL
BUTALBITAL AND ACETAMINOPHEN
HALSEY
325MG;50MG
WATSON LABS
325MG;50MG
SEDAPAP
MAYRAND
650MG;50MG

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

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 2 (of 346)

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

CAPSULE; ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
MALLINCKRODT
325MG;50MG;40MG
BUTALIBITAL, ACETAMINOPHEN AND CAFFEINE
GILBERT LABS
325MG;50MG;40MG
FEMCET
MALLINCKRODT
325MG;50MG;40MG
MEDIGESIC PLUS
US CHEM
325MG;50MG;40MG
TRIAD
MALLINCKRODT
325MG;50MG;40MG
TABLET; ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ABLE
325MG;50MG;40MG
500MG;50MG;40MG
GILBERT LABS
325MG;50MG;40MG
MUTUAL PHARM
325MG;50MG;40MG
WATSON LABS
325MG;50MG;40MG
ESGIC
FOREST PHARMS
325MG;50MG;40MG

A088758

001

Mar 27, 1985

A088825

001

Dec 05, 1984

A089102

001

Jun 19, 1985

A089115

001

Jan 14, 1986

A089023

001

Jun 19, 1985

A040390
A040394
A087629
A040601
A089536

001
001
001
001
001

Jul
Jul
Nov
Jul
Feb

A089660

001

Dec 23, 1988

A076528

001

Aug 21, 2003

A088584

001

Mar 04, 1986

A089166

001

May 14, 1986

A040637

001

Sep 22, 2006

A088537
A088324
A088599

001
001
001

Jun 04, 1984

Dec 29, 1983
Jun 01, 1984

A084444

001

A084445

001

A084446

001

A085685

001

A087422

001

A087421

001

A085861
A040098
A086366

001
001
001

A085057

001

23,
23,
13,
29,
16,

2001
2001
1984
2005
1988

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE; ORAL
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ABLE
325MG;50MG;40MG;30MG

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

CAPSULE; ORAL
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
WEST-WARD PHARM CORP 712.8MG;60MG;32MG

ACETAMINOPHEN; CODEINE PHOSPHATE

CAPSULE; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
TEVA
300MG;15MG
300MG;30MG
300MG;60MG
PHENAPHEN W/ CODEINE NO. 2
ROBINS AH
325MG;15MG
PHENAPHEN W/ CODEINE NO. 3
ROBINS AH
325MG;30MG
PHENAPHEN W/ CODEINE NO. 4
ROBINS AH
325MG;60MG
PROVAL #3
SOLVAY
325MG;30MG
TYLENOL W/ CODEINE NO. 3
ORTHO MCNEIL PHARM
300MG;30MG
TYLENOL W/ CODEINE NO. 4
ORTHO MCNEIL PHARM
300MG;60MG
SOLUTION; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
ACTAVIS MID ATLANTIC 120MG/5ML;12MG/5ML
CLONMEL
120MG/5ML;12MG/5ML
ROXANE
120MG/5ML;12MG/5ML
TYLENOL W/ CODEINE
ORTHO MCNEIL PHARM
120MG/5ML;12MG/5ML

Sep 20, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 3 (of 346)

ACETAMINOPHEN; CODEINE PHOSPHATE

SUSPENSION; ORAL
CAPITAL AND CODEINE
ACTAVIS MID ATLANTIC 120MG/5ML;12MG/5ML
TABLET; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
ABLE
300MG;30MG
300MG;60MG
AM THERAP
300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
DURAMED PHARMS BARR
300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
EVERYLIFE
325MG;30MG
HALSEY
300MG;15MG
300MG;30MG
300MG;60MG
KV PHARM
300MG;30MG
300MG;60MG
325MG;15MG
325MG;45MG
LEDERLE
300MG;30MG
MIKART
300MG;60MG
MUTUAL PHARM
300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
PURACAP PHARM
300MG;30MG
PUREPAC PHARM
300MG;30MG
300MG;30MG
300MG;60MG
ROXANE
300MG;15MG
300MG;30MG
300MG;60MG
500MG;15MG
500MG;30MG
500MG;60MG
SANDOZ
300MG;15MG
300MG;30MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
300MG;60MG
SUPERPHARM
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
USL PHARMA
300MG;30MG
300MG;60MG
VALEANT PHARM INTL
300MG;30MG
VITARINE
300MG;30MG
WARNER CHILCOTT
300MG;15MG

A085883

001

A040452
A040459
A089478
A089481
A089479
A089482
A089480
A089483
A040223
A088353
A040223
A088354
A040223
A088355
A085217
A083871
A083872
A086549
A085288
A085365
A085364
A085363
A087141
A089244
A085795
A089671
A085794
A089672
A087653
A089673
A087762
A086681
A089080
A086683
A084659
A084656
A084667
A089511
A089512
A089513
A087433
A081250
A085291
A085917
A081249
A085964
A087423
A089183
A089184
A089253
A089185
A089254
A087919
A087920
A085896
A085676
A085992

001
001
001
001
001
001
001
001
001
001
002
001
003
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Aug
Aug
Mar
Mar
Mar
Mar
Mar
Mar
Nov
Feb
Nov
Feb
Nov
Feb

01,
01,
03,
03,
03,
03,
03,
03,
18,
06,
18,
06,
18,
06,

2002
2002
1987
1987
1987
1987
1987
1987
1997
1984
1997
1984
1997
1984

Feb 25, 1986

Feb 10, 1988
Feb
Apr
Feb
Dec

10,
13,
10,
10,

1988
1982
1988
1982

Jul 17, 1986

Apr 25, 1989

Apr 25, 1989
Apr 25, 1989
Jul 16, 1992

Jul 16, 1992

Oct
Oct
May
Oct
May
Jun
Jun

18,
18,
19,
18,
19,
22,
22,

1985
1985
1986
1985
1986
1982
1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 4 (of 346)

ACETAMINOPHEN; CODEINE PHOSPHATE

TABLET; ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
WARNER CHILCOTT
300MG;30MG
300MG;60MG
WATSON LABS
300MG;15MG
300MG;15MG
300MG;30MG
300MG;30MG
300MG;60MG
300MG;60MG
WATSON LABS FLORIDA
300MG;15MG
300MG;30MG
300MG;60MG
WHITEWORTH TOWN PLSN 300MG;30MG
300MG;60MG
CAPITAL AND CODEINE
CARNRICK
325MG;30MG
CODRIX
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
VANGARD
300MG;30MG
PAPA-DEINE #4
VANGARD
300MG;60MG
PHENAPHEN-650 W/ CODEINE
ROBINS AH
650MG;30MG
TYLENOL W/ CODEINE
ORTHO MCNEIL PHARM
325MG;7.5MG
325MG;15MG
325MG;30MG
325MG;60MG
TYLENOL W/ CODEINE NO. 1
JANSSEN PHARMS
300MG;7.5MG
TYLENOL W/ CODEINE NO. 2
JANSSEN PHARMS
300MG;15MG

A085218
A087306
A087277
A089997
A087276
A089998
A087275
A089999
A040443
A040443
A040443
A084360
A085607

002
001
001
001
001
001
001
001
001
002
003
001
001

A083643

001

A040447
A040441
A040488

001
001
001

A083951

001

A083951

002

A088037

001

Mar 20, 1984

A088715

001

Mar 20, 1984

A085856

001

A085056
A085056
A085056
A085056

001
002
003
004

A085055

001

A085055

002

A088898

001

Mar 27, 1985

A089907

001

Jan 13, 1989

A087961

001

Mar 17, 1983

A089360

001

Mar 02, 1988

A088956
A089006
A081068
A081069
A081070

001
001
001
001
001

Jul
Aug
Nov
Nov
Nov

A087336

001

Jul 08, 1982

A040508

001

Aug 29, 2003

May
Dec
May
Dec
May
Dec
Jan
Jan
Jan

26,
28,
26,
28,
26,
28,
22,
22,
22,

1982
1994
1982
1994
1982
1994
2003
2003
2003

Feb 26, 2003

Mar 27, 2003
Mar 28, 2003

ACETAMINOPHEN; HYDROCODONE BITARTRATE

CAPSULE; ORAL
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
CENT PHARMS
500MG;5MG
ALLAY
IVAX PHARMS
500MG;5MG
BANCAP HC
FOREST PHARMS
500MG;5MG
CO-GESIC
CENT PHARMS
500MG;5MG
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MALLINCKRODT
500MG;5MG
500MG;5MG
MIKART
500MG;5MG
500MG;5MG
500MG;5MG
LORCET-HD
MALLINCKRODT
500MG;5MG
SOLUTION; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MALLINCKRODT INC
500MG/15ML;10MG/15ML

19,
09,
30,
30,
30,

1985
1985
1989
1989
1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 5 (of 346)

ACETAMINOPHEN; HYDROCODONE BITARTRATE

SOLUTION; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MIKART
500MG/15ML;5MG/15ML
500MG/15ML;5MG/15ML
TABLET; ORAL
DURADYNE DHC
FOREST PHARMS
500MG;5MG
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ABLE
325MG;5MG
325MG;7.5MG
325MG;10MG
500MG;5MG
500MG;7.5MG
500MG;10MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
BARR
500MG;2.5MG
500MG;5MG
500MG;5MG
500MG;7.5MG
500MG;10MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
ENDO PHARMS
500MG;5MG
500MG;7.5MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
HALSEY
500MG;5MG
IVAX PHARMS
500MG;5MG
MIKART
500MG;5MG
500MG;5MG
MUTUAL PHARM
500MG;5MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
RANBAXY
500MG;5MG
500MG;10MG
RANBAXY LABS LTD
325MG;10MG
750MG;7.5MG
SANDOZ
500MG;5MG
750MG;7.5MG
UCB INC
500MG;10MG
650MG;7.5MG
USL PHARMA
500MG;5MG
500MG;5MG
VINTAGE PHARMS
500MG;5MG
WATSON LABS
325MG;7.5MG
325MG;10MG
500MG;2.5MG
500MG;5MG
500MG;7.5MG
650MG;7.5MG
650MG;10MG
750MG;7.5MG
WATSON LABS FLORIDA
500MG;5MG
750MG;7.5MG
HY-PHEN
ASCHER
500MG;5MG

A081226
A089557

001
001

Oct 27, 1992

Apr 29, 1992

A087809

001

Mar 17, 1983

A040478
A040464
A040464
A040477
A040490
A040473
A040474
A040476
A040469
A040307
A040308
A088577
A040307
A040309
A040307
A040307
A040308
A040281
A040280
A040280
A040280
A040281
A089554
A089696
A089271
A089697
A040236
A040240
A040240
A040236
A040825
A040824
A040826
A040822
A040149
A040149
A040210
A040134
A089290
A089291
A089831
A040248
A040248
A040123
A040122
A040123
A040123
A040123
A040122
A040493
A040494

001
001
002
001
001
001
001
001
001
001
001
001
002
001
003
004
002
001
001
002
003
002
001
001
001
001
001
002
001
002
001
001
001
001
001
002
001
001
001
001
001
001
002
003
001
004
001
002
002
001
001

Nov
Oct
Oct
Nov
May
Nov
Jan
Oct
Oct
Jul
Jul
Dec
Jul
Jul
Jul
Jul
Jul
Sep
Sep
Sep
Sep
Sep
Jun
Apr
Jul
Jan
Sep
Nov
Nov
Sep
Aug
Aug
Aug
Aug
Jan
Jan
Aug
Nov
May
May
Sep
Apr
Apr
Mar
Mar
Mar
Mar
Mar
Mar
May
May

A087677

001

May 03, 1982

08,
23,
23,
06,
21,
06,
02,
23,
25,
26,
26,
21,
26,
26,
26,
26,
26,
30,
30,
30,
30,
30,
12,
21,
16,
28,
25,
26,
26,
25,
16,
16,
16,
16,
27,
27,
13,
21,
29,
29,
07,
28,
28,
04,
04,
04,
04,
04,
04,
28,
28,

2002
2002
2002
2002
2003
2002
2003
2002
2002
2000
2000
1984
2000
2000
2000
2000
2000
1998
1998
1998
1998
1998
1987
1988
1986
1992
1997
1997
1997
1997
2007
2007
2007
2007
1997
1997
1997
1996
1987
1987
1988
2000
2000
1996
1996
1996
1996
1996
1996
2003
2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 6 (of 346)

ACETAMINOPHEN; HYDROCODONE BITARTRATE

TABLET; ORAL
NORCET
ABANA
TYCOLET
ORTHO MCNEIL PHARM
VICODIN
ABBOTT

500MG;5MG

A088871

001

May 15, 1986

500MG;5MG

A089385

001

Aug 27, 1986

500MG;5MG

A085667

001

A040199
A040304
A040303
A089994
A040219

001
001
001
001
001

Dec
Oct
Dec
May
Jan

A088246

001

Nov 08, 1984

A040680

001

Sep 29, 2006

A085910

001

A085911

001

A040203
A087406
A040272

001
001
001

A085106

002

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

CAPSULE; ORAL
OXYCODONE AND ACETAMINOPHEN
ACTAVIS TOTOWA
500MG;5MG
BARR
500MG;5MG
ENDO PHARMS
500MG;5MG
HALSEY
500MG;5MG
MUTUAL PHARM
500MG;5MG
TYLOX-325
ORTHO MCNEIL PHARM
325MG;5MG
SOLUTION; ORAL
OXYCODONE AND ACETAMINOPHEN
MALLINCKRODT INC
325MG/5ML;5MG/5ML
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
ACTAVIS TOTOWA
325MG;5MG
BARR
325MG;5MG
DURAMED PHARMS BARR
325MG;5MG
PERCOCET
ENDO PHARMS
325MG;5MG

30,
02,
30,
04,
22,

1998
2000
1999
1989
1998

Mar 15, 1999

Jun 30, 1998

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

CAPSULE; ORAL
TYLOX
ORTHO MCNEIL PHARM

500MG;4.5MG;0.38MG

A085375

001

N018458

001

N016844

001

A085100

001

A083689
A083978
A089959
A040507
A040139

001
001
001
001
001

A084999

001

A076429

001

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

TABLET; ORAL
TALACEN
SANOFI AVENTIS US

650MG;EQ 25MG BASE

Sep 23, 1982

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

TABLET; ORAL
DARVOCET
AAIPHARMA LLC
325MG;32.5MG
DOLENE AP-65
LEDERLE
650MG;65MG
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
MYLAN
325MG;32MG
650MG;65MG
SANDOZ
650MG;65MG
VINTAGE PHARMS
650MG;65MG
WATSON LABS
650MG;65MG
WYGESIC
LEITNER PHARMS
650MG;65MG

Jul 18, 1989

Jul 30, 2003
Dec 16, 1996

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

TABLET; ORAL
DARVOCET A500
XANODYNE PHARM

500MG;100MG

Sep 10, 2003

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 7 (of 346)

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

TABLET; ORAL
DARVOCET-N 100
XANODYNE PHARM
650MG;100MG
DARVOCET-N 50
XANODYNE PHARM
325MG;50MG
PROPACET 100
TEVA
650MG;100MG
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
ABLE
650MG;100MG
ACTAVIS ELIZABETH
650MG;100MG
CORNERSTONE
325MG;100MG
500MG;100MG
HALSEY
325MG;50MG
650MG;100MG
IVAX SUB TEVA PHARMS 650MG;100MG
MALLINCKRODT
650MG;100MG
MIRROR PHARMS
650MG;100MG
MUTUAL PHARM
325MG;50MG
650MG;100MG
650MG;100MG
650MG;100MG
650MG;100MG
MYLAN
650MG;100MG
MYLAN PHARMS INC
650MG;100MG
SANDOZ
650MG;100MG
SUPERPHARM
650MG;100MG
TEVA
650MG;100MG
650MG;100MG
VINTAGE PHARMS
325MG;50MG
650MG;100MG
WATSON LABS
325MG;50MG
650MG;100MG
WATSON LABS FLORIDA
500MG;100MG
650MG;100MG
WOCKHARDT LTD
325MG;50MG
650MG;100MG

N017122

002

N017122

001

A070107

001

Jun 12, 1985

A075838
A070910
A076743
A076750
A072105
A072106
A070146
A075738
A077821
A070115
A070116
A070615
A070771
A070775
A072195
A070145
A070443
A071319
A070732
A074119
A074843
A074843
A070398
A070399
A077196
A076609
A077677
A077677

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
002

Jul
Jan
May
Jun
May
May
Aug
Feb
Feb
Jun
Jun
Mar
Mar
Mar
Feb
Jun
Jan
Jan
Jan
Dec
Feb
Feb
Dec
Dec
Jun
Nov
Mar
Mar

250MG
250MG
250MG
250MG
250MG

A083320
A087686
A089753
A087654
A084498

001
001
001
001
002

Oct 20, 1982

Jun 22, 1988
Feb 05, 1982

125MG
250MG

N008943
N008943

001
002

EQ 500MG BASE/VIAL

A040108

001

2%

A087146

001

2%

A085493

001

2%

A086845

001

11,
02,
07,
28,
13,
13,
02,
02,
11,
12,
12,
21,
21,
21,
16,
12,
23,
06,
03,
19,
15,
12,
18,
18,
28,
16,
16,
16,

2001
1987
2004
2004
1988
1988
1985
2001
2008
1985
1985
1986
1986
1986
1988
1985
1986
1987
1986
1994
2001
1997
1986
1986
2005
2004
2007
2007

ACETAZOLAMIDE
TABLET; ORAL
ACETAZOLAMIDE
ALRA
ASCOT
MUTUAL PHARM
VANGARD
WATSON LABS
DIAMOX
DURAMED PHARMS BARR

ACETAZOLAMIDE SODIUM
INJECTABLE; INJECTION
ACETAZOLAMIDE SODIUM
HOSPIRA

ACETIC ACID, GLACIAL

SOLUTION/DROPS; OTIC
ACETASOL
ACTAVIS MID ATLANTIC
ACETIC ACID
KV PHARM
ORLEX
WARNER CHILCOTT

Oct 30, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 8 (of 346)

ACETIC ACID, GLACIAL; ALUMINUM ACETATE

SOLUTION/DROPS; OTIC
BOROFAIR
PHARMAFAIR
DOMEBORO
BAYER PHARMS

2%;0.79%

A088606

001

2%;0.79%

A084476

001

N017914

001

A085492

001

A040097
A040168

001
001

A086844

001

2%;1%;EQ 0.35% BASE

N050238

001

250MG
500MG
250MG
500MG

A070869
A070870
A070753
A070754

001
001
001
001

250MG
500MG

N013378
N013378

002
001

20MG

N012254

002

53%

N009008

001

20MG/VIAL

N016211

001

A071364
A071365
A072621
A072622

001
001
001
001

N013601
N013601

002
001

Aug 21, 1985

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%

Oct 31, 1994

Aug 30, 1996

ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE

SUSPENSION/DROPS; OTIC
NEO-CORT-DOME
BAYER PHARMS

ACETOHEXAMIDE
TABLET; ORAL
ACETOHEXAMIDE
BARR
USL PHARMA
DYMELOR
LILLY

Feb
Feb
Nov
Nov

09,
09,
03,
03,

1987
1987
1986
1986

May
May
Sep
Sep

01,
01,
30,
30,

1989
1989
1992
1992

ACETOPHENAZINE MALEATE
TABLET; ORAL
TINDAL
SCHERING

ACETRIZOATE SODIUM
SOLUTION; INTRAUTERINE
SALPIX
ORTHO MCNEIL PHARM

ACETYLCHOLINE CHLORIDE
FOR SOLUTION; OPHTHALMIC
MIOCHOL
NOVARTIS

ACETYLCYSTEINE
SOLUTION; INHALATION, ORAL
ACETYLCYSTEINE
HOSPIRA
10%
20%
ROXANE
10%
20%
MUCOMYST
APOTHECON
10%
20%

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 9 (of 346)

ACETYLCYSTEINE
SOLUTION; INHALATION, ORAL
MUCOSIL-10
DEY
10%
MUCOSIL-20
DEY
20%

A070575

001

Oct 14, 1986

A070576

001

Oct 14, 1986

N017366

001

0.1MG

N009436

001

2MG/GM

N012470

001

200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG

A074906
A074889
A074872
A074674
A074750
A074570
A074828
A074914

001
001
001
001
001
002
001
001

Aug
Oct
Apr
Apr
Apr
Apr
Apr
Nov

26,
31,
22,
22,
22,
22,
22,
26,

1997
1997
1997
1997
1997
1997
1997
1997

400MG
800MG
400MG
800MG
400MG
800MG
400MG
800MG
400MG
800MG
200MG
400MG
800MG

A074870
A074870
A074891
A074891
A074834
A074834
A074836
A074836
A074658
A074658
A074556
A075021
A075021

001
002
001
002
001
002
001
002
001
002
001
001
002

Jun
Jun
Oct
Oct
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Mar
Mar

05,
05,
31,
31,
24,
24,
22,
22,
22,
22,
22,
18,
18,

1997
1997
1997
1997
1997
1997
1997
1997
1997
1997
1997
1998
1998

EQ 50MG BASE/ML

A075114

001

Jul 26, 1999

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A074897
A074897
A074720
A075065
A074663
A074758
A074663
A074758
A075627

001
002
001
001
001
001
002
002
001

Feb
Feb
Apr
Feb
Apr
Apr
Apr
Apr
Mar

ACETYLCYSTEINE; ISOPROTERENOL HYDROCHLORIDE

SOLUTION; INHALATION
MUCOMYST W/ ISOPROTERENOL
MEAD JOHNSON
10%;0.05%

ACETYLDIGITOXIN
TABLET; ORAL
ACYLANID
NOVARTIS

ACRISORCIN
CREAM; TOPICAL
AKRINOL
SCHERING

ACYCLOVIR
CAPSULE; ORAL
ACYCLOVIR
ACTAVIS ELIZABETH
BELCHER PHARMS
DAVA PHARMS INC
IVAX SUB TEVA PHARMS
LEK PHARM
ROXANE
TEVA
TEVA PHARMS
TABLET; ORAL
ACYCLOVIR
ACTAVIS ELIZABETH
BELCHER PHARMS
DAVA PHARMS INC
IVAX SUB TEVA PHARMS
LEK PHARM
TEVA
TEVA PHARMS

ACYCLOVIR SODIUM
INJECTABLE; INJECTION
ACYCLOVIR
ABBOTT
ACYCLOVIR SODIUM
APOTHECON
HOSPIRA

TEVA PARENTERAL

500MG BASE/VIAL
1GM BASE/VIAL
25MG BASE/ML
50MG BASE/ML
500MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
50MG BASE/ML

27,
27,
22,
25,
22,
22,
22,
22,
28,

1998
1998
1997
1999
1997
1997
1997
1997
2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 10 (of 346)

ACYCLOVIR SODIUM
INJECTABLE; INJECTION
ACYCLOVIR SODIUM
TEVA PARENTERAL
ZOVIRAX
GLAXOSMITHKLINE

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

A074969
A074969

001
002

Aug 26, 1997

Aug 26, 1997

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

N018603
N018603
N018603

003
001
002

Aug 30, 1983

Oct 22, 1982
Jun 29, 1989

0.1%

N020338

001

May 31, 1996

3MG/ML

A076501

001

Jun 16, 2004

N020760
N020760

001
002

Dec 18, 1997

Dec 18, 1997

N017835
N017835
N017835

001
002
003

N017846

001

N017844
N017844
N017844

003
001
002

N017837
N017837
N017837

003
004
005

A072273
A073045
A073272
A074072

001
001
001
001

N017559

001

N018473

001

ADAPALENE
SOLUTION; TOPICAL
DIFFERIN
GALDERMA LABS LP

ADENOSINE
INJECTABLE; INJECTION
ADENOSINE
BAXTER HLTHCARE

ALATROFLOXACIN MESYLATE
INJECTABLE; INJECTION
TROVAN PRESERVATIVE FREE
PFIZER
EQ 200MG BASE/VIAL
EQ 300MG BASE/VIAL

ALBUMIN CHROMATED CR-51 SERUM

INJECTABLE; INJECTION
CHROMALBIN
ISO TEX

100uCi/VIAL
250uCi/VIAL
500uCi/VIAL

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

ALBUMIN IODINATED I-131 SERUM

INJECTABLE; INJECTION
MEGATOPE
ISO TEX

2mCi/VIAL
5uCi/AMP
20uCi/AMP

ALBUTEROL
AEROSOL, METERED; INHALATION
ALBUTEROL
ARMSTRONG PHARMS
0.09MG/INH
GENPHARM
0.09MG/INH
IVAX SUB TEVA PHARMS 0.09MG/INH
PLIVA
0.09MG/INH
PROVENTIL
SCHERING
0.09MG/INH
VENTOLIN
GLAXOSMITHKLINE
0.09MG/INH

Aug
Aug
Dec
Aug

14,
19,
28,
01,

1996
1997
1995
1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 11 (of 346)

ALBUTEROL SULFATE
CAPSULE; INHALATION
VENTOLIN ROTACAPS
GLAXOSMITHKLINE
SOLUTION; INHALATION
ALBUTEROL SULFATE
ACTAVIS MID ATLANTIC
BAUSCH AND LOMB
COPLEY PHARM

EQ 0.2MG BASE

N019489

001

May 04, 1988

EQ
EQ
EQ
EQ
EQ

0.083% BASE
0.083% BASE
0.083% BASE
0.5% BASE
0.083% BASE

A073533
A075358
A073495
A073307
A075129

001
001
001
001
001

Sep
Mar
May
Nov
Feb

EQ 0.083% BASE
EQ 0.5% BASE

N019243
N019243

002
001

Jan 14, 1987

Jan 14, 1987

EQ 0.083% BASE
EQ 0.5% BASE

N019773
N019269

001
002

Apr 23, 1992

Jan 16, 1987

EQ 2MG BASE/5ML
EQ 2MG BASE/5ML
EQ 2MG BASE/5ML

A075262
A074302
A073165

001
001
001

Mar 30, 1999

Sep 30, 1994
Apr 29, 1993

EQ 2MG BASE/5ML

N018062

001

Jan 19, 1983

EQ 2MG BASE/5ML

N019621

001

Jun 10, 1987

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A072449
A072450
A072966
A072967
A072859
A072860
A072316
A072317
A072151
A072152
A072619
A072779
A072938
A072620
A072780
A072939
A073120
A073121
A072817
A072818
A072629
A072630
A072765

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Dec
Dec
Nov
Nov
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Jun
Mar
Dec
Jun
Mar
Sep
Sep
Jan
Jan
Jan
Jan
Aug

EQ 2MG BASE
EQ 4MG BASE

N017853
N017853

001
002

May 07, 1982

May 07, 1982

EQ 2MG BASE
EQ 4MG BASE
TABLET, EXTENDED RELEASE; ORAL
PROVENTIL
SCHERING
EQ 4MG BASE
VOLMAX
MURO
EQ 4MG BASE
EQ 8MG BASE

N019112
N019112

001
002

Jul 10, 1986

Jul 10, 1986

N019383

001

Jul 13, 1987

N019604
N019604

002
001

Dec 23, 1992

Dec 23, 1992

ROXANE
PROVENTIL
SCHERING
VENTOLIN
GLAXOSMITHKLINE
SYRUP; ORAL
ALBUTEROL SULFATE
ACTAVIS MID ATLANTIC
MOVA
WATSON LABS
PROVENTIL
SCHERING
VENTOLIN
GLAXOSMITHKLINE
TABLET; ORAL
ALBUTEROL SULFATE
AM THERAP
COPLEY PHARM
DAVA PHARMS INC
PLIVA
SANDOZ
TEVA

UCB INC
WARNER CHILCOTT
WATSON LABS

PROVENTIL
SCHERING
VENTOLIN
GLAXOSMITHKLINE

2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
2MG
2MG
2MG
4MG
4MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG
4MG

26,
29,
28,
27,
13,

05,
05,
22,
22,
20,
20,
05,
05,
05,
05,
05,
25,
30,
05,
25,
30,
29,
29,
09,
09,
31,
31,
28,

1995
2000
1993
1991
2001

1989
1989
1991
1991
1989
1989
1989
1989
1989
1989
1989
1993
1990
1989
1993
1990
1992
1992
1990
1990
1991
1991
1991

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DISCONTINUED DRUG PRODUCT LIST

6 - 12 (of 346)

ALCOHOL
INJECTABLE; INJECTION
ALCOHOL 5% IN DEXTROSE 5%
MILES
5ML/100ML

A083483

001

A083263

001

A083256

001

A075871
A075871
A075871
A075871
A075871
A076184
A076184

001
002
004
003
005
002
001

Apr
Apr
Apr
Apr
Apr
Aug
Feb

10 UNITS/ML

N020057

004

May 08, 1992

2MG
3MG

N007336
N007336

002
003

100MG
300MG
100MG
300MG
100MG
300MG
100MG
300MG
100MG
300MG
100MG
100MG
300MG
300MG

A070466
A070467
A070150
A070147
A070579
A070580
A070268
A070269
A070950
A070951
N018241
N018785
N018241
N018785

001
001
001
001
001
001
001
001
001
001
001
001
002
002

100MG
300MG

N018297
N018297

001
002

0.5MG/5ML

A074314

001

Oct 31, 1993

0.25MG
0.5MG

A074294
A074294

001
002

Jul 29, 1994

Jul 29, 1994

ALCOHOL; DEXTROSE
INJECTABLE; INJECTION
ALCOHOL 5% IN D5-W
HOSPIRA
5ML/100ML;5GM/100ML
ALCOHOL 5% IN DEXTROSE 5% IN WATER
BAXTER HLTHCARE
5ML/100ML;5GM/100ML

ALENDRONATE SODIUM
TABLET; ORAL
ALENDRONATE SODIUM
SANDOZ

TEVA PHARMS

EQ
EQ
EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
35MG BASE
40MG BASE
70MG BASE
35MG BASE
70MG BASE

22,
22,
22,
22,
22,
04,
06,

2009
2009
2009
2009
2009
2008
2008

ALGLUCERASE
INJECTABLE; INJECTION
CEREDASE
GENZYME

ALKAVERVIR
TABLET; ORAL
VERILOID
3M

ALLOPURINOL
TABLET; ORAL
ALLOPURINOL
MUTUAL PHARM
PURACAP PHARM
PUREPAC PHARM
SANDOZ
SUPERPHARM
WATSON LABS

LOPURIN
ABBOTT

Dec
Dec
Dec
Dec
Apr
Apr
Dec
Dec
Nov
Nov
Nov
Sep
Nov
Sep

24,
24,
10,
10,
14,
14,
31,
31,
30,
30,
16,
28,
16,
28,

1985
1985
1985
1985
1986
1986
1985
1985
1988
1988
1984
1984
1984
1984

ALPRAZOLAM
SOLUTION; ORAL
ALPRAZOLAM
ROXANE
TABLET; ORAL
ALPRAZOLAM
IVAX SUB TEVA PHARMS

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DISCONTINUED DRUG PRODUCT LIST

6 - 13 (of 346)

ALPRAZOLAM
TABLET; ORAL
ALPRAZOLAM
IVAX SUB TEVA PHARMS
ROXANE

TEVA

WATSON LABS

1MG
2MG
0.25MG
0.5MG
1MG
0.25MG
0.5MG
1MG
2MG
0.25MG
0.25MG
0.5MG
0.5MG
1MG
1MG

A074294
A074294
A074199
A074199
A074199
A074085
A074085
A074085
A074085
A074456
A074479
A074456
A074479
A074456
A074479

003
004
001
002
003
001
002
003
004
001
001
002
002
003
003

Jul
Jul
Oct
Oct
Oct
Feb
Feb
Feb
Feb
Aug
Jan
Aug
Jan
Aug
Jan

29,
29,
19,
19,
19,
16,
16,
16,
26,
31,
21,
31,
21,
31,
21,

1994
1994
1993
1993
1993
1994
1994
1994
1996
1995
1997
1995
1997
1995
1997

0.005MG/ML
0.01MG/ML
0.02MG/ML

N020755
N020755
N020755

001
002
003

Oct 31, 1997

Oct 01, 1997
Oct 01, 1997

0.005MG/VIAL

N020649

001

Jun 12, 1997

2MG

N009215

001

2MG

N008867

001

A089449

001

Nov 27, 1987

A072687

001

Jun 28, 1989

A077659
A071382

001
001

Feb 23, 2006

Jan 21, 1987

A071000

001

Sep 04, 1986

N016020

001

A072655
A073115

001
001

N016023

002

N018101

001

ALPROSTADIL
INJECTABLE; INJECTION
CAVERJECT
PFIZER

EDEX
SCHWARZ PHARMA

ALSEROXYLON
TABLET; ORAL
RAUTENSIN
NOVARTIS
RAUWILOID
3M

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

TABLET, CHEWABLE; ORAL
ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE
PENNEX
80MG;20MG
FOAMICON
NOVARTIS
80MG;20MG

AMANTADINE HYDROCHLORIDE
CAPSULE; ORAL
AMANTADINE HYDROCHLORIDE
ACTAVIS TOTOWA
100MG
WATSON LABS
100MG
SYMADINE
SOLVAY
100MG
SYMMETREL
ENDO PHARMS
100MG
SYRUP; ORAL
AMANTADINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 50MG/5ML
TEVA PHARMS
50MG/5ML
SYMMETREL
ENDO PHARMS
50MG/5ML
TABLET; ORAL
SYMMETREL
ENDO PHARMS
100MG

Oct 30, 1990

Aug 23, 1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 14 (of 346)

AMCINONIDE
CREAM; TOPICAL
CYCLOCORT
ASTELLAS
LOTION; TOPICAL
CYCLOCORT
ASTELLAS
OINTMENT; TOPICAL
CYCLOCORT
ASTELLAS

0.025%
0.1%

N018116
N018116

001
002

0.1%

N019729

001

0.1%

N018498

001

250MG/VIAL
500MG/VIAL
1GM/VIAL

N050565
N050565
N050565

001
002
003

Dec 21, 1984

Dec 21, 1984
Dec 21, 1984

375MG/VIAL

N020221

002

Sep 10, 1999

A063265
A063266
A063167
A063169
A063274
A063275
A063350
A063283
A063350
A064098
A064099
A064045

001
001
001
001
001
001
001
001
002
001
001
001

Nov
Oct
Dec
Dec
May
May
Jul
Oct
Jul
Jun
Jun
Sep

A064146

001

Apr 02, 1997

A062311
A062562
N050495
A062311
A062562
N050495

001
001
001
002
002
002

N050618
N050618

002
001

Nov 30, 1987

Nov 30, 1987

AND HYDROCHLOROTHIAZIDE
EQ 5MG ANHYDROUS;50MG
EQ 5MG ANHYDROUS;50MG
EQ 5MG ANHYDROUS;50MG

A073357
A070795
A073334

001
001
001

Nov 27, 1991

Apr 17, 1988
Jul 19, 1991

EQ 5MG ANHYDROUS;50MG

A070347

001

Dec 25, 1990

EQ 5MG ANHYDROUS;50MG

N018201

001

Jun 13, 1988

AMDINOCILLIN
INJECTABLE; INJECTION
COACTIN
ROCHE

AMIFOSTINE
INJECTABLE; INJECTION
ETHYOL
MEDIMMUNE

AMIKACIN SULFATE
INJECTABLE; INJECTION
AMIKACIN SULFATE
ABBOTT

EQ 250MG BASE/ML
EQ 250MG BASE/ML
ASTRAZENECA
EQ 50MG BASE/ML
EQ 250MG BASE/ML
BAXTER HLTHCARE
EQ 50MG BASE/ML
EQ 250MG BASE/ML
HOSPIRA
EQ 50MG BASE/ML
EQ 62.5MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
TEVA PARENTERAL
EQ 50MG BASE/ML
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA
EQ 500MG BASE/100ML
AMIKIN
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
APOTHECON
EQ 5MG BASE/ML
EQ 10MG BASE/ML

30,
31,
14,
14,
18,
18,
30,
31,
30,
26,
20,
28,

1994
1994
1995
1995
1992
1992
1993
1994
1993
1995
1995
1993

Sep 20, 1984

Sep 20, 1984

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
AMILORIDE HYDROCHLORIDE
SANDOZ
TEVA
WATSON LABS
HYDRO-RIDE
PAR PHARM
MODURETIC 5-50
MERCK

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 15 (of 346)

AMINO ACIDS
INJECTABLE; INJECTION
AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE
HOSPIRA
5.2% (5.2GM/100ML)
AMINOSYN 3.5% IN PLASTIC CONTAINER
ABBOTT
3.5% (3.5GM/100ML)
3.5% (3.5GM/100ML)
AMINOSYN II 3.5%
HOSPIRA
3.5% (3.5GM/100ML)
AMINOSYN II 3.5% IN PLASTIC CONTAINER
ABBOTT
3.5% (3.5GM/100ML)
AMINOSYN II 5%
HOSPIRA
5% (5GM/100ML)
AMINOSYN-HBC 7% IN PLASTIC CONTAINER
ABBOTT
7% (7GM/100ML)
BRANCHAMIN 4%
BAXTER HLTHCARE
4% (4GM/100ML)
FREAMINE 8.5%
B BRAUN
8.5% (8.5GM/100ML)
FREAMINE II 8.5%
B BRAUN
8.5% (8.5GM/100ML)
NEOPHAM 6.4%
HOSPIRA
6.4% (6.4GM/100ML)
NOVAMINE 11.4%
HOSPIRA INC
11.4% (11.4GM/100ML)
NOVAMINE 15%
HOSPIRA INC
15% (15GM/100ML)
NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER
BAXTER HLTHCARE
15% (15GM/100ML)
NOVAMINE 8.5%
HOSPIRA INC
8.5% (8.5GM/100ML)

N018901

001

Apr 06, 1984

N018804
N018875

001
001

May 15, 1984

Aug 08, 1984

N019438

001

Apr 03, 1986

N019491

001

Oct 10, 1986

N019438

002

Apr 03, 1986

N019400

001

Jul 23, 1986

N018678

001

Sep 28, 1984

N016822

001

N016822

002

N018792

001

Jan 17, 1984

N017957

003

Aug 09, 1982

N017957

004

Nov 28, 1986

N020107

001

Feb 05, 1993

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
;22.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC
3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML N019683 001
Nov
;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
L;22.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC
4.25%;36.8MG/100ML;20GM/100ML;51MG/100M N019683 002
Nov
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
L;22.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC
4.25%;36.8MG/100ML;25GM/100ML;51MG/100M N019683 003
Nov
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
2.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC
5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2 N019683 004
Nov
2.4MG/100ML;261MG/100ML;205MG/100ML

12, 1988
07, 1988

12, 1988
07, 1988

12, 1988
07, 1988

12, 1988
07, 1988

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

N019118

001

Oct 11, 1984

N019120

001

Oct 11, 1984

N019119

001

Oct 11, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 16 (of 346)

AMINO ACIDS; DEXTROSE

INJECTABLE; INJECTION
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

N019505
N019713
N019681

002
006
001

Nov 07, 1986

Sep 09, 1988
Nov 01, 1988

N019506
N019713
N019681

001
002
002

Nov 07, 1986

Sep 09, 1988
Nov 01, 1988

N019713
N019681

001
004

Sep 09, 1988

Nov 01, 1988

N019713
N019681

004
005

Sep 09, 1988

Nov 01, 1988

N019504
N019713
N019681

002
005
003

Nov 07, 1986

Sep 09, 1988
Nov 01, 1988

N019565
N019713
N019681

001
003
006

Dec 17, 1986

Sep 09, 1988
Nov 01, 1988

N019520

002

Sep 23, 1988

N019520

003

Sep 23, 1988

N019520

004

Sep 23, 1988

N019520

005

Sep 23, 1988

N019520

001

Sep 23, 1988

N019520

007

Sep 23, 1988

N019520

008

Sep 23, 1988

N019520

009

Sep 23, 1988

N019520

010

Sep 23, 1988

N019520

006

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
;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
L;261MG/100ML;205MG/100ML

002

Dec 16, 1986

004

Dec 16, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 17 (of 346)

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
Oct
;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
Oct
;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
Oct
;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
Oct
;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
Oct
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
Oct
;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
Oct
;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
Oct
;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
Oct
;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
Oct
297MG/100ML;77MG/100ML

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

23, 1995

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
234MG/100ML
3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N018875
234MG/100ML

002

May 15, 1984

002

Aug 08, 1984

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

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 18 (of 346)

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
;49MG/100ML

001

Oct 16, 1986

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
8MG/100ML

001

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
10MG/100ML

006

Apr 03, 1986

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; N019437
49MG/100ML

007

Apr 03, 1986

250MG/ML

N015229

002

250MG/ML
250MG/ML
250MG/ML

A070522
N018590
A070888

001
001
001

250MG

N018202

001

300MG/5ML

N018232

001

Apr 02, 1982

25MG/ML
25MG/ML

A087243
A087621

001
001

May 24, 1982

May 24, 1982

25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML

A084568
A087200
A087250
A087886
A088407
A087239
A087601
A087867
A087868
A086606
A087240
A087431
A087387
A088429

001
001
001
001
001
001
001
001
001
001
001
001
001
001

AMINOCAPROIC ACID
INJECTABLE; INJECTION

AMICAR

XANODYNE PHARM
AMINOCAPROIC ACID
ABRAXIS PHARM
BAXTER HLTHCARE
HOSPIRA

Jun 17, 1986

Oct 29, 1982
Jun 16, 1988

AMINOGLUTETHIMIDE
TABLET; ORAL

CYTADREN

NOVARTIS

AMINOPHYLLINE
ENEMA; RECTAL
SOMOPHYLLIN
FISONS
INJECTABLE; INJECTION
AMINOPHYLLIN
GD SEARLE LLC
AMINOPHYLLINE
ABRAXIS PHARM

ELKINS SINN
HOSPIRA
INTL MEDICATION
KING PHARMS
LUITPOLD
LYPHOMED
PHARMA SERVE NY
SMITH AND NEPHEW

Jan 06, 1982

Aug 30, 1983
Jan 25, 1984
Jul 23, 1982
Nov 10, 1983
Nov 10, 1983

Jun 03, 1983

May 30, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 19 (of 346)

AMINOPHYLLINE
INJECTABLE; INJECTION
AMINOPHYLLINE
SMITH AND NEPHEW
TEVA PARENTERAL
AMINOPHYLLINE IN SODIUM
HOSPIRA

25MG/ML
25MG/ML
CHLORIDE 0.45%
100MG/100ML
200MG/100ML
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA
100MG/100ML
200MG/100ML
400MG/100ML
500MG/100ML
SOLUTION; ORAL
AMINOPHYLLINE
MORTON GROVE
105MG/5ML
ROXANE
105MG/5ML
AMINOPHYLLINE DYE FREE
ACTAVIS MID ATLANTIC 105MG/5ML
SOMOPHYLLIN
FISONS
105MG/5ML
SOMOPHYLLIN-DF
FISONS
105MG/5ML
SUPPOSITORY; RECTAL
TRUPHYLLINE
G AND W LABS
250MG
500MG
TABLET; ORAL
AMINOPHYLLIN
GD SEARLE LLC
100MG
200MG
AMINOPHYLLINE
ASCOT
100MG
200MG
BARR
100MG
200MG
DURAMED PHARMS BARR
100MG
200MG
HALSEY
100MG
IMPAX LABS
100MG
200MG
KV PHARM
100MG
200MG
LANNETT
100MG
200MG
PAL PAK
100MG
PANRAY
100MG
200MG
PUREPAC PHARM
100MG
200MG
ROXANE
100MG
200MG
SANDOZ
100MG
100MG
200MG
VALEANT PHARM INTL
200MG
VANGARD
100MG
200MG
VINTAGE PHARMS
100MG
200MG
WATSON LABS
100MG
200MG

A088749
A081142

001
001

May 30, 1985

Sep 25, 1991

A088147
A088147

002
003

May 03, 1983

May 03, 1983

N018924
N018924
N018924
N018924

001
002
003
004

Dec
Dec
Dec
Dec

A088156
A088126

001
001

Dec 05, 1983

Aug 19, 1983

A087727

001

Apr 16, 1982

A086466

001

A087045

001

A085498
A085498

001
002

N002386
N002386

002
003

A087522
A087523
A088297
A088298
A088182
A088183
A084674
A084574
A084576
A085284
A085289
A084588
A084588
A084533
A084552
A084552
A084699
A085333
A087500
A087501
A085261
A085262
A085261
A084563
A088314
A088319
A085409
A085410
A085567
A085564

001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
002
001
001
001
001
003
002
002
001
001
001
001
001
001
001

12,
12,
12,
12,

1984
1984
1984
1984

Mar 23, 1983

Jan 03, 1983

Feb
Feb
Aug
Aug
Mar
Mar

12,
12,
19,
19,
31,
31,

1982
1982
1983
1983
1983
1983

Feb 09, 1982

Feb 09, 1982

Oct 03, 1983

Oct 03, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 20 (of 346)

AMINOPHYLLINE
TABLET, DELAYED RELEASE; ORAL
AMINOPHYLLINE
IMPAX LABS
100MG
200MG
TABLICAPS
100MG
VALE
100MG
200MG
TABLET, EXTENDED RELEASE; ORAL
PHYLLOCONTIN
PHARM RES ASSOC
225MG

A084577
A084575
A084632
A084531
A084530

001
001
002
001
001

A086760

001

A080947

001

A080097

001

N006811
N006811

006

011

A080138

002

N007320

002

846MG;112MG

A080059

002

500MG
1GM

N006811
N006811

001
002

N009052

001

A076088
A076108
N021594

001
001
001

Oct 15, 2002

Oct 15, 2002
Feb 04, 2004

N020377

001

Aug 03, 1995

A074895

001

Apr 16, 1999

A085749

001

A085594

001

AMINOSALICYLATE SODIUM
POWDER; ORAL
P.A.S. SODIUM

CENTURY PHARMS
4GM/PACKET
SODIUM AMINOSALICYLATE

HEXCEL
100%
TABLET; ORAL

PARASAL SODIUM

PANRAY
500MG
1GM
SODIUM P.A.S.

LANNETT
500MG
TEEBACIN

CONSOLIDATED MIDLAND 500MG

AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID

TABLET; ORAL
NEOPASALATE
MEDPOINTE PHARM HLC

AMINOSALICYLIC ACID
TABLET; ORAL
PARASAL
PANRAY

AMINOSALICYLIC ACID RESIN COMPLEX

POWDER; ORAL
REZIPAS
BRISTOL MYERS SQUIBB

EQ 500MG BASE/GM

AMIODARONE HYDROCHLORIDE
INJECTABLE; INJECTION
AMIODARONE HYDROCHLORIDE
BEN VENUE
50MG/ML
HOSPIRA
50MG/ML
INTL MEDICATION SYS
50MG/ML
CORDARONE
WYETH PHARMS INC
50MG/ML
TABLET; ORAL
AMIODARONE HYDROCHLORIDE
TEVA
200MG

AMITRIPTYLINE HYDROCHLORIDE
CONCENTRATE; ORAL
ENDEP
ROCHE
40MG/ML
INJECTABLE; INJECTION
AMITRIPTYLINE HYDROCHLORIDE
WATSON LABS
10MG/ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 21 (of 346)

AMITRIPTYLINE HYDROCHLORIDE
INJECTABLE; INJECTION
ELAVIL
ASTRAZENECA
TABLET; ORAL
AMITID
BRISTOL MYERS SQUIBB

10MG/ML

N012704

001

10MG
25MG
50MG
75MG
100MG

A086454
A086454
A086454
A086454
A086454

001
002
003
004
005

10MG
25MG
50MG
75MG
100MG
150MG
AMITRIPTYLINE HYDROCHLORIDE
AM THERAP
25MG
50MG
75MG
100MG
COPLEY PHARM
10MG
25MG
50MG
75MG
100MG
150MG
HALSEY
10MG
25MG
50MG
50MG
75MG
100MG
LEDERLE
10MG
10MG
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

A083939
A083937
A083938
A084957
A085093
A086295

001
001
002
001
001
001

A088672
A088673
A088674
A088675
A088421
A088422
A088423
A088424
A088425
A088426
A085923
A085922
A085925
A087557
A085926
A085927
A086744
A087366
A086746
A087367
A086743
A087181
A086745
A087369
A086747
A087368
A087370
A085744
A085627
A085745
A085743
A085742
A089423
A088697
A088698
A088699
A088700
A088701
A088702
A088883
A088884
A088885
A088886
A088887

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001
001
001
001

AMITRIL
WARNER CHILCOTT

Nov
Nov
Nov
Nov
Apr
Apr
Apr
Apr
Apr
Apr

20,
20,
20,
20,
30,
30,
30,
30,
30,
30,

1984
1984
1984
1984
1984
1984
1984
1984
1984
1984

Mar 05, 1982

May 20, 1983
May 20, 1983
Jan 04, 1982
May 03, 1982
Jan 04, 1982
Jan 04, 1982
May 03, 1982
Jan 04, 1982

May
Feb
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

11,
17,
25,
25,
25,
25,
25,
25,
26,
26,
26,
26,
26,

1982
1987
1984
1984
1984
1984
1984
1984
1984
1984
1984
1984
1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 22 (of 346)

AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL
AMITRIPTYLINE HYDROCHLORIDE
PLIVA
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
100MG
150MG
USL PHARMA
25MG
VANGARD
10MG
50MG
75MG
100MG
WATSON LABS
10MG
10MG
25MG
25MG
50MG
50MG
75MG
75MG
100MG
100MG

A088888
A088075
A088084
A088076
A088085
A088077
A088105
A088078
A088106
A088079
A088107
A086002
A086144
A085944
A086145
A085945
A086143
A086004
A086147
A086003
A086146
A086090
A086148
A088853
A088854
A088855
A088856
A088857
A084910
A086610
A085031
A086859
A085032
A086857
A085030
A086860
A085836
A086854
A086853
A085864
A085935
A085936
A086337
A086336
A086335
A087775
A087632
A087616
A087617
A087639
A085816
A088620
A085817
A088621
A085815
A088622
A085819
A088633
A085820
A088634

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
003
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Sep
Sep
Jul
May
Jul
Sep
Jul
Sep
Jul
Sep
Jul

26,
16,
18,
20,
18,
16,
18,
16,
18,
16,
18,

1984
1983
1983
1983
1983
1983
1983
1983
1983
1983
1983

Nov
Nov
Nov
Nov
Nov

13,
13,
13,
13,
13,

1984
1984
1984
1984
1984

Feb
Feb
Feb
Feb
Feb

10,
01,
08,
05,
08,

1982
1982
1982
1982
1982

Mar 02, 1984

Mar 02, 1984
Mar 02, 1984
Mar 02, 1984
Mar 02, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 23 (of 346)

AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL
AMITRIPTYLINE HYDROCHLORIDE
WATSON LABS
150MG
150MG
WEST WARD
10MG
25MG
ELAVIL
ASTRAZENECA
10MG
25MG
50MG
75MG
100MG
150MG
ENDEP
ROCHE
10MG
25MG
50MG
75MG
100MG
150MG

A085821
A088635
A087647
A087278

001
001
001
001

N012703
N012703
N012703
N012703
N012703
N012703

001
003
004
005
006
007

A083639
A083639
A083639
A083639
A083639
A085303

001
002
003
004
005
001

A070765
A070766
A072277
A072278
A070477
A070478
A072052
A072053

001
001
001
001
001
001
001
001

N014713

007

N014713

004

N014713

002

N014713

006

A070935
A070937
A070936
A070938
A070939
A071077
A071078
A070297
A071079
A070565
A070620
A070621
A070595
A070574
A071062
A071862
A071063
A071064

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Mar 02, 1984

Mar 05, 1982

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

Dec
Dec
May
May
Jan
Jan
Dec
Dec

10,
10,
09,
09,
12,
12,
16,
16,

1986
1986
1988
1988
1988
1988
1988
1988

Sep
Sep
Sep
Sep
Sep
Nov
Nov
Nov
Nov
Sep
Sep
Sep
Sep
Sep
Nov
Dec
Nov
Nov

11,
11,
11,
11,
12,
12,
12,
12,
12,
11,
11,
11,
11,
11,
27,
21,
27,
27,

1986
1986
1986
1986
1986
1986
1986
1986
1986
1986
1986
1986
1986
1986
1987
1987
1987
1987

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
25MG;2MG
25MG;4MG
PAR PHARM
10MG;2MG
10MG;4MG
25MG;2MG
25MG;4MG
50MG;4MG
SANDOZ
10MG;2MG
10MG;4MG
25MG;2MG
25MG;4MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 24 (of 346)

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

TABLET; ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
SANDOZ
50MG;4MG
WATSON LABS
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
TRIAVIL 2-10
NEW RIVER
10MG;2MG
TRIAVIL 2-25
NEW RIVER
25MG;2MG
TRIAVIL 4-10
NEW RIVER
10MG;4MG
TRIAVIL 4-25
NEW RIVER
25MG;4MG
TRIAVIL 4-50
NEW RIVER
50MG;4MG

A071863
A070373
A072539
A073007
A070375
A072540
A073009
A070374
A072541
A073008
A070376
A072134
A073010
A070377
A071558
A072135

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Dec
Aug
Feb
Oct
Aug
Feb
Oct
Aug
Feb
Oct
Aug
Feb
Oct
Nov
Mar
Feb

21,
25,
15,
17,
25,
15,
17,
25,
15,
17,
25,
15,
17,
04,
02,
15,

1987
1986
1989
1991
1986
1989
1991
1986
1989
1991
1986
1989
1991
1986
1987
1989

N014715

004

N014715

002

N014715

003

N014715

005

N014715

006

N021727

001

Sep 29, 2004

A077333
A077333
A077333
A077362
A077362
A077362
A078081
A078081
A078081
A077080
A077080
A077080

001
002
003
001
002
003
001
002
003
001
002
003

Jul
Jul
Jul
Jul
Jul
Jul
Jan
Jan
Jan
Jun
Jun
Jun

N022026
N022026
N022026

001
002
003

Sep 27, 2007

Sep 27, 2007
Sep 27, 2007

N021435
N021435
N021435

001
002
003

Oct 31, 2003

Oct 31, 2003
Oct 31, 2003

AMLEXANOX
PATCH; TOPICAL
AMLEXANOX
ULURU

2MG

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
SYNTHON PHARMS
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE
TABLET, ORALLY DISINTEGRATING; ORAL
AMLODIPINE BESYLATE
SYNTHON PHARMS
EQ 2.5MG BASE
EQ 5MG BASE
EQ 10MG BASE

17,
17,
17,
09,
09,
09,
31,
31,
31,
27,
27,
27,

2007
2007
2007
2007
2007
2007
2008
2008
2008
2007
2007
2007

AMLODIPINE MALEATE
TABLET; ORAL
AMVAZ
DR REDDYS LABS INC

2.5MG
5MG
10MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 25 (of 346)

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

A083130
A086205

001
001

N006580

001

A085734

001

EQ 200MG BASE

N006441

001

25MG
50MG
100MG
150MG
25MG
50MG
100MG
150MG

A072943
A072944
A072878
A072879
A072418
A072419
A072420
A072421

001
001
001
001
001
001
001
001

25MG
50MG
100MG
150MG

N018021
N018021
N018021
N018021

001
002
003
004

250MG
500MG
250MG
500MG
250MG
250MG
500MG
500MG

A062528
A062528
A062067
A062067
A062853
A063030
A062854
A063031

001
002
001
002
001
001
001
001

250MG
500MG

N050459
N050459

001
002

250MG
250MG
250MG
250MG
500MG
500MG
500MG
500MG

A061885
A062098
A062152
A063099
A061885
A062098
A062152
A063099

001
001
001
001
002
002
002
002

250MG
500MG

A062107
A062107

001
002

250MG
500MG

A062120
A062120

001
002

AMODIAQUINE HYDROCHLORIDE
TABLET; ORAL
CAMOQUIN HYDROCHLORIDE
PARKE DAVIS

AMOXAPINE
TABLET; ORAL
AMOXAPINE
SANDOZ

WATSON LABS

ASENDIN
LEDERLE

Jun
Jun
Jun
Jun
May
May
May
May

28,
28,
28,
28,
11,
11,
11,
11,

1991
1991
1991
1991
1989
1989
1989
1989

AMOXICILLIN
CAPSULE; ORAL
AMOXICILLIN
LABS ATRAL
MYLAN
TEVA

AMOXIL
GLAXOSMITHKLINE
TRIMOX
APOTHECON

UTIMOX
PARKE DAVIS
WYMOX
WYETH AYERST

Aug 07, 1985

Aug 07, 1985

Dec
Feb
Dec
Feb

22,
28,
22,
28,

1987
1989
1987
1989

Mar 20, 1992

Mar 20, 1992

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 26 (of 346)

AMOXICILLIN
FOR SUSPENSION; ORAL

AMOXICILLIN

AM ANTIBIOTICS
MYLAN
TEVA
AMOXIL
GLAXOSMITHKLINE

LAROTID

GLAXOSMITHKLINE
POLYMOX

APOTHECON

TRIMOX
APOTHECON

UTIMOX

PARKE DAVIS
WYMOX

WYETH AYERST

125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML

A062059
A062059
A062090
A062090
A062946
A063001

001

002

001

002

001
001

50MG/ML
125MG/5ML
250MG/5ML

N050460
N050460
N050460

005

001

002

50MG/ML

N050460

006

125MG/5ML
125MG/5ML
250MG/5ML
250MG/5ML

A061851
A062323
A061851
A062323

001

001

002

002

50MG/ML
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML

A061886
A061886
A062099
A062154
A062885
A061886
A062099
A062154
A062885

001
002
001
001
001
003
002
002
002

125MG/5ML
250MG/5ML

A062127
A062127

001

002

125MG/5ML
250MG/5ML

A062131
A062131

001

002

A064131
A064131
A064031
A064031

001
002
001
002

May
May
Dec
Dec

A065080
A065080

002
001

Aug 11, 2003

Aug 11, 2003

TABLET, CHEWABLE; ORAL

AMOXICILLIN

APOTHECON

125MG
250MG
TEVA
125MG
250MG
TABLET, FOR SUSPENSION; ORAL
DISPERMOX
RANBAXY LABS LTD
200MG
400MG

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE;

DEXTROAMPHETAMINE SULFATE
CAPSULE; ORAL
DELCOBESE
TEVA

TABLET; ORAL

DELCOBESE

TEVA

1.25MG;1.25MG;1.25MG;1.25MG
2.5MG;2.5MG;2.5MG;2.5MG
3.75MG;3.75MG;3.75MG;3.75MG
5MG;5MG;5MG;5MG

A083564
A083564
A083564
A083564

001

002

003

004

1.25MG;1.25MG;1.25MG;1.25MG
2.5MG;2.5MG;2.5MG;2.5MG
3.75MG;3.75MG;3.75MG;3.75MG
5MG;5MG;5MG;5MG

A083563
A083563
A083563
A083563

004

003

002

001

Nov 01, 1988

Jan 06, 1989

Mar 08, 1988

Mar 08, 1988

06,
06,
19,
19,

1996
1996
1996
1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 27 (of 346)

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE;

DEXTROAMPHETAMINE SULFATE
TABLET; ORAL
ADDERALL 10
TEVA WOMENS
2.5MG;2.5MG;2.5MG;2.5MG
N011522
ADDERALL 12.5
TEVA WOMENS
3.125MG;3.125MG;3.125MG;3.125MG
N011522
ADDERALL 15
TEVA WOMENS
3.75MG;3.75MG;3.75MG;3.75MG
N011522
ADDERALL 20
TEVA WOMENS
5MG;5MG;5MG;5MG
N011522
ADDERALL 30
TEVA WOMENS
7.5MG;7.5MG;7.5MG;7.5MG
N011522
ADDERALL 5
TEVA WOMENS
1.25MG;1.25MG;1.25MG;1.25MG
N011522
ADDERALL 7.5
TEVA WOMENS
1.875MG;1.875MG;1.875MG;1.875MG
N011522
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
MALLINCKRODT INC
1.25MG;1.25MG;1.25MG;1.25MG
A040440
1.875MG;1.875MG;1.875MG;1.875MG
A040440
2.5MG;2.5MG;2.5MG;2.5MG
A040440
3.125MG;3.125MG;3.125MG;3.125MG
A040440
3.75MG;3.75MG;3.75MG;3.75MG
A040440
5MG;5MG;5MG;5MG
A040440
7.5MG;7.5MG;7.5MG;7.5MG
A040440
MUTUAL PHARM
1.25MG;1.25MG;1.25MG;1.25MG
A040480
1.875MG;1.875MG;1.875MG;1.875MG
A040480
2.5MG;2.5MG;2.5MG;2.5MG
A040480
3.125MG;3.125MG;3.125MG;3.125MG
A040480
3.75MG;3.75MG;3.75MG;3.75MG
A040480
5MG;5MG;5MG;5MG
A040480
7.5MG;7.5MG;7.5MG;7.5MG
A040480
WATSON LABS
1.25MG;1.25MG;1.25MG;1.25MG
A040456
2.5MG;2.5MG;2.5MG;2.5MG
A040456
5MG;5MG;5MG;5MG
A040456
7.5MG;7.5MG;7.5MG;7.5MG
A040456

007

Feb 13, 1996

012

Aug 31, 2000

013

Aug 31, 2000

008

Feb 13, 1996

010

May 12, 1997

009

May 12, 1997

011

Aug 31, 2000

001
002
003
004
005
006
007
001
002
003
004
005
006
007
001
002
003
004

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Sep
Sep
Sep
Sep
Sep
Sep
Sep
May
May
May
May

07,
07,
07,
07,
07,
07,
07,
09,
09,
09,
09,
09,
09,
09,
06,
06,
06,
06,

2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003

AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE; ORAL

BIPHETAMINE 12.5

UCB INC
EQ 6.25MG BASE;EQ 6.25MG BASE
BIPHETAMINE 20

UCB INC
EQ 10MG BASE;EQ 10MG BASE
BIPHETAMINE 7.5

UCB INC
EQ 3.75MG BASE;EQ 3.75MG BASE

N010093

007

N010093

003

N010093

009

5MG
10MG

A083901
A083901

001
002

3%

N050314

001

50MG/VIAL
50MG/VIAL
50MG/VIAL

A064141
A062728
A064062

001
001
001

50MG/VIAL

A060517

001

AMPHETAMINE SULFATE
TABLET; ORAL
AMPHETAMINE SULFATE
LANNETT

Aug 31, 1984

Aug 31, 1984

AMPHOTERICIN B
CREAM; TOPICAL
FUNGIZONE
APOTHECON
INJECTABLE; INJECTION
AMPHOTERICIN B
ABBOTT
ABRAXIS PHARM
TEVA PARENTERAL
FUNGIZONE
APOTHECON

Dec 23, 1996

Apr 13, 1987
Mar 31, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 28 (of 346)

AMPHOTERICIN B
LOTION; TOPICAL
FUNGIZONE
APOTHECON
OINTMENT; TOPICAL
FUNGIZONE
APOTHECON
SUSPENSION; ORAL
FUNGIZONE
BRISTOL MYERS SQUIBB

3%

A060570

001

3%

N050313

001

100MG/ML

N050341

003

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
125MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL

A062860
A062860
A062860
A062860
A062860
A062692
A062692
A062692
A062692
A062692
A062692
A061936
A061936
A061936
A061936
A061936
A063143
A063147
A063139
A063141
A062634
A062634
A062565
A062565
A062565
A062816
A062816
A062816
A062816
A062816
A062994

001
002
003
004
005
001
002
003
004
005
006
005
001
002
003
004
001
001
001
001
002
003
001
002
003
001
002
003
004
005
001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

125MG BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL

A060626
A062718
A060626
A062718
A060626
A062718
A060626
A062718
A060626
A062718

001
001
002
002
003
003
004
004
005
005

EQ
EQ
EQ
EQ
EQ
EQ

125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL

N050072
N050072
N050072
N050072
N050072
N050072

001
002
003
004
005
006

AMPICILLIN SODIUM
INJECTABLE; INJECTION
AMPICILLIN SODIUM
APOTHECON

BAXTER HLTHCARE

CONSOLIDATED PHARM

HANFORD GC

INTL MEDICATION
LILLY

MARSAM PHARMS LLC

OMNIPEN-N
WYETH AYERST

PENBRITIN-S
WYETH AYERST

Feb
Feb
Feb
Feb
Feb
Jun
Jun
Jun
Jun
Jun
Jun

05,
05,
05,
05,
05,
24,
24,
24,
24,
24,
24,

1988
1988
1988
1988
1988
1986
1986
1986
1986
1986
1986

Apr
Apr
Apr
Apr
Jan
Jan
Apr
Apr
Jun
Oct
Oct
Oct
Oct
Oct
Sep

15,
15,
15,
15,
09,
09,
04,
04,
24,
24,
24,
24,
24,
24,
15,

1993
1993
1993
1993
1987
1987
1985
1985
1986
1988
1988
1988
1988
1988
1988

Dec 16, 1986

Dec 16, 1986
Dec 16, 1986
Dec 16, 1986
Dec 16, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 29 (of 346)

AMPICILLIN SODIUM
INJECTABLE; INJECTION
POLYCILLIN-N
BRISTOL

TOTACILLIN-N
GLAXOSMITHKLINE

EQ
EQ
EQ
EQ
EQ

125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL

N050309
N050309
N050309
N050309
N050309

001
002
003
004
005

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL

A060677
A060677
A060677
A060677
A062727
A060677
A062727
A060677

001
002
003
004
001
005
002
006

N050608

003

EQ 250MG BASE
EQ 500MG BASE

A062041
A062041

001
002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A061602
A061602
A060765
A060765
A062208
A062208
A061755
A061755
A061853
A061853
A061502
A061502
A061387
A061387

001
002
001
002
001
002
001
002
001
002
001
002
001
003

250MG
500MG

A060624
A060624

001
002

EQ 250MG BASE
EQ 500MG BASE

A060908
A060908

001
002

EQ 250MG BASE
EQ 500MG BASE

A062050
A062050

001
002

EQ 250MG BASE
EQ 500MG BASE

N050310
N050310

001
002

EQ
EQ
EQ
EQ

BASE
BASE
BASE
BASE

A062888
A062888
A061392
A061392

001
002
001
002

EQ 250MG BASE
EQ 250MG BASE

A062157
N050056

002
001

Dec 19, 1986

Dec 19, 1986

AMPICILLIN SODIUM; SULBACTAM SODIUM

INJECTABLE; INJECTION
UNASYN
PFIZER

EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL

Dec 31, 1986

AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE; ORAL
AMCILL
PARKE DAVIS
AMPICILLIN TRIHYDRATE
AM ANTIBIOTICS
IVAX SUB TEVA PHARMS
LEDERLE
MYLAN
PUREPAC PHARM
TEVA
VITARINE
OMNIPEN (AMPICILLIN)
WYETH AYERST
PENBRITIN
WYETH AYERST
PFIZERPEN-A
PFIZER
POLYCILLIN
BRISTOL
PRINCIPEN
APOTHECON
BRISTOL MYERS SQUIBB
PRINCIPEN '250'
APOTHECON

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

Mar 04, 1988

Mar 04, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 30 (of 346)

AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE; ORAL
PRINCIPEN '500'
APOTHECON
TOTACILLIN
GLAXOSMITHKLINE

FOR SUSPENSION; ORAL

AMCILL
PARKE DAVIS
AMPICILLIN TRIHYDRATE
AM ANTIBIOTICS
MYLAN
PUREPAC PHARM
TEVA
OMNIPEN (AMPICILLIN)
WYETH AYERST

PENBRITIN
WYETH AYERST

PFIZERPEN-A
PFIZER
POLYCILLIN
APOTHECON
BRISTOL

PRINCIPEN
APOTHECON

PRINCIPEN '125'
APOTHECON
PRINCIPEN '250'
APOTHECON
TOTACILLIN
GLAXOSMITHKLINE

TABLET, CHEWABLE; ORAL

POLYCILLIN
BRISTOL

EQ 500MG BASE
EQ 500MG BASE

A062157
N050056

001
002

EQ
EQ
EQ
EQ

A060060
A062212
A060060
A062212

001
001
002
002

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

A062030
A062030

001
002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A061601
A061601
A061829
A061829
A061980
A061980
A061370
A061370

001
002
002
001
001
002
001
002

100MG/ML
125MG/5ML
250MG/5ML
500MG/5ML

A060625
A060625
A060625
A060625

001
002
003
004

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

N050019
N050019
N050019

001
002
003

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

A062049
A062049

001
002

EQ
EQ
EQ
EQ
EQ
EQ

BASE/5ML
BASE/5ML
BASE/ML
BASE/5ML
BASE/5ML
BASE/5ML

A062297
A062297
N050308
N050308
N050308
N050308

001
002
004
001
002
003

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

A061394
A061394
A061394

001
002
003

EQ 125MG BASE/5ML
EQ 125MG BASE/5ML

A060127
A062151

002
001

EQ 250MG BASE/5ML
EQ 250MG BASE/5ML

A060127
A062151

001
002

EQ
EQ
EQ
EQ

A060666
A062223
A060666
A062223

001
001
002
002

N050093

001

250MG
250MG
500MG
500MG

125MG
250MG
125MG
250MG
125MG
250MG
125MG
250MG

125MG
250MG
100MG
125MG
250MG
500MG

125MG
125MG
250MG
250MG

BASE
BASE
BASE
BASE

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

EQ 125MG BASE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 31 (of 346)

AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID

CAPSULE; ORAL
PRINCIPEN W/ PROBENECID
APOTHECON
EQ
EQ
FOR SUSPENSION; ORAL
POLYCILLIN-PRB
APOTHECON
EQ
BRISTOL
EQ
PROBAMPACIN
TEVA
EQ

389MG BASE;111MG
389MG BASE;111MG

A062150
N050488

001
001

3.5GM BASE/BOT;1GM/BOT
3.5GM BASE/BOT;1GM/BOT

A061898
N050457

001
001

3.5GM BASE/BOT;1GM/BOT

A061741

001

50MG
150MG

N021007
N021007

001
002

Apr 15, 1999

Apr 15, 1999

15MG/ML

N021039

001

Apr 15, 1999

N020333

002

Mar 14, 1997

A076489
A076489

001
002

Apr 18, 2005

Apr 18, 2005

1MG

A078322

001

Jun 28, 2010

EQ 25MG BASE

N010585

002

25MG/ML

N010520

003

50MG

N010909

003

A086046

001

N013428

001

N018746

002

AMPRENAVIR
CAPSULE; ORAL
AGENERASE
GLAXOSMITHKLINE
SOLUTION; ORAL
AGENERASE
GLAXOSMITHKLINE

ANAGRELIDE HYDROCHLORIDE
CAPSULE; ORAL
AGRYLIN
SHIRE
EQ 1MG BASE
ANAGRELIDE HYDROCHLORIDE
ROXANE
EQ 0.5MG BASE
EQ 1MG BASE

ANASTROZOLE
TABLET; ORAL
ANASTROZOLE
SYNTHON PHARMS

ANILERIDINE HYDROCHLORIDE
TABLET; ORAL
LERITINE
MERCK

ANILERIDINE PHOSPHATE
INJECTABLE; INJECTION
LERITINE
MERCK

ANISINDIONE
TABLET; ORAL
MIRADON
SCHERING

ANISOTROPINE METHYLBROMIDE
TABLET; ORAL
ANISOTROPINE METHYLBROMIDE
WATSON LABS
50MG
VALPIN 50
ENDO PHARMS
50MG

ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE

SOLUTION/DROPS; OPHTHALMIC
VASOCON-A
NOVARTIS
0.5%;0.05%

Jul 11, 1994

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 32 (of 346)

APOMORPHINE HYDROCHLORIDE
INJECTABLE; SUBCUTANEOUS
APOKYN
US WORLDMEDS

20MG/2ML (10MG/ML)

N021264

001

Apr 20, 2004

0.05MG/ML

N020420

001

Sep 12, 1997

5,000 UNITS/0.5ML
10,000 UNITS/0.5ML

N020227
N020227

002
001

May 23, 1997

May 23, 1997

125MG/125ML (1MG/ML)

N201743

001

May 09, 2011

N021729
N021729

004
005

Jun 07, 2006

Jun 07, 2006

N021875
N021875

002
005

Mar 26, 2009

Mar 26, 2009

ARBUTAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
GENESA
GENSIA AUTOMEDICS

ARDEPARIN SODIUM
INJECTABLE; INJECTION
NORMIFLO
PHARMACIA AND UPJOHN

ARGATROBAN
SOLUTION; IV (INFUSION)
ARGATROBAN IN DEXTROSE
SANDOZ

ARIPIPRAZOLE
TABLET, ORALLY DISINTEGRATING; ORAL
ABILIFY
OTSUKA
20MG
30MG

ARMODAFINIL
TABLET; ORAL
NUVIGIL
CEPHALON

100MG
200MG

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; N006071
100
IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;
1.5MG/ML;1,650 IU/ML;5 IU/ML

003

Oct 10, 1985

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

M.V.I.-12
HOSPIRA

MVC PLUS
WATSON LABS

10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N018440
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
ML;0.3MG/ML;330 UNITS/ML;1 IU/ML

002

Aug 08, 1985

10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N008809
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
ML;0.3MG/ML;330 UNITS/ML;1 IU/ML

004

Aug 08, 1985

10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N018439
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
ML;0.3MG/ML;330 UNITS/ML;1 IU/ML

002

Aug 08, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 33 (of 346)

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
0
IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/M
L;0.6MG/ML;330 UNITS/ML;1 IU/ML

005

Apr 22, 2004

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
G/VIAL;5MCG/VIAL;0.4MG/VIAL;40MG/VIAL;4
MG/VIAL;3.6MG/VIAL;3MG/VIAL;1MG/VIAL;10
MG/VIAL

002

Aug 08, 1985

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
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

001

Dec 29, 1993

N021317

001

Oct 18, 2001

N016030

001

N016030

002

A088305

001

Oct 13, 1983

A078149
A086231

001
002

Jun 13, 2007

Feb 12, 1985

A086710
A089448
A085441
A087048
A088972
A086398
A086237

002
001
002
002
001
002
002

Aug
Dec
Oct
Dec
Jun
Apr
Mar

N017534

003

Apr 16, 1986

A086986

002

Oct 18, 1985

ASPIRIN
TABLET; ORAL
BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN
BAYER
500MG
TABLET, EXTENDED RELEASE; ORAL
8-HOUR BAYER
BAYER
650MG
MEASURIN
BAYER
650MG

ASPIRIN; BUTALBITAL
TABLET; ORAL
AXOTAL
SAVAGE LABS

650MG;50MG

ASPIRIN; BUTALBITAL; CAFFEINE

CAPSULE; ORAL
BUTALBITAL, ASPIRIN AND CAFFEINE
MUTUAL PHARM
325MG;50MG;40MG
WATSON LABS
325MG;50MG;40MG
TABLET; ORAL
BUTALBITAL, ASPIRIN AND CAFFEINE
ACTAVIS ELIZABETH
325MG;50MG;40MG
HALSEY
325MG;50MG;40MG
IVAX PHARMS
325MG;50MG;40MG
PURACAP PHARM
325MG;50MG;40MG
QUANTUM PHARMICS
325MG;50MG;40MG
SANDOZ
325MG;50MG;40MG
WATSON LABS
325MG;50MG;40MG
FIORINAL
WATSON LABS INC
325MG;50MG;40MG
LANORINAL
LANNETT
325MG;50MG;40MG

23,
01,
31,
09,
18,
06,
23,

1983
1986
1984
1983
1985
1984
1984

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DISCONTINUED DRUG PRODUCT LIST

6 - 34 (of 346)

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE; ORAL
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
ENDO PHARMS
325MG;50MG;40MG;30MG

A075351

001

Mar 05, 1999

385MG;30MG;25MG

A075141

001

May 29, 1998

770MG;60MG;50MG

A075141

002

May 29, 1998

A084553

002

Aug 17, 1983

N010996

006

Mar 08, 1983

N010996

007

Mar 08, 1983

A083077
A080044
A089025

002
002
001

Dec 07, 1984

Sep 16, 1983
Mar 29, 1985

A083101

002

Jun 24, 1985

A085732

002

Sep 03, 1984

A088809

001

Oct 03, 1985

500MG;5MG

A089420

001

Jan 25, 1988

500MG;5MG

A086333

001

Sep 14, 1983

325MG;200MG

N011702

003

Dec 29, 1983

325MG;200MG

A089127

001

Mar 02, 1987

325MG;200MG

A089126

001

Aug 19, 1986

325MG;200MG

A084978

001

325MG;200MG

A088740

001

Jun 01, 1984

TABLET; ORAL
METHOCARBAMOL AND ASPIRIN
IVAX SUB TEVA PHARMS 325MG;400MG
MCNEIL
325MG;400MG
PAR PHARM
325MG;400MG
ROBAXISAL
ROBINS AH
325MG;400MG

A087211
A089193
A089657

001
001
001

Dec 22, 1982

Feb 12, 1986
Nov 04, 1988

N012281

001

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

TABLET; ORAL
ORPHENGESIC
SOLCO HLTHCARE
ORPHENGESIC FORTE
SOLCO HLTHCARE

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE

CAPSULE; ORAL
COMPOUND 65
ALRA
389MG;32.4MG;65MG
DARVON COMPOUND
XANODYNE PHARM
389MG;32.4MG;32MG
DARVON COMPOUND-65
XANODYNE PHARM
389MG;32.4MG;65MG
PROPOXYPHENE COMPOUND 65
IVAX SUB TEVA PHARMS 389MG;32.4MG;65MG
SANDOZ
389MG;32.4MG;65MG
TEVA
389MG;32.4MG;65MG
PROPOXYPHENE COMPOUND-65
SANDOZ
389MG;32.4MG;65MG
PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE
WATSON LABS
389MG;32.4MG;65MG

ASPIRIN; CARISOPRODOL
TABLET; ORAL
CARISOPRODOL COMPOUND
WATSON LABS

325MG;200MG

ASPIRIN; HYDROCODONE BITARTRATE

TABLET; ORAL
AZDONE
SCHWARZ PHARMA
VICOPRIN
ABBOTT

ASPIRIN; MEPROBAMATE
TABLET; ORAL
EQUAGESIC
CARACO
MEPRO-ASPIRIN
SANDOZ
MEPROBAMATE AND ASPIRIN
PAR PHARM
MICRAININ
MEDPOINTE PHARM HLC
Q-GESIC
QUANTUM PHARMICS

ASPIRIN; METHOCARBAMOL

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6 - 35 (of 346)

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

TABLET; ORAL
CODOXY
HALSEY
OXYCODONE AND ASPIRIN
MUTUAL PHARM

325MG;4.5MG;0.38MG

325MG;4.5MG;0.38MG
325MG;4.5MG;0.38MG
OXYCODONE AND ASPIRIN (HALF-STRENGTH)
ROXANE
325MG;2.25MG;0.19MG
PERCODAN
ENDO PHARMS
325MG;4.5MG;0.38MG
PERCODAN-DEMI
ENDO PHARMS
325MG;2.25MG;0.19MG
ROXIPRIN
ROXANE
325MG;4.5MG;0.38MG

A087464

001

Jul 01, 1982

A040260
A087794

001
001

Jul 17, 1998

May 26, 1982

A087742

001

Jun 04, 1982

N007337

006

N007337

005

A087743

001

N016891

001

N021387

006

Jun 24, 2003

N021387
N021387
N021387
N021387
N021387

001
002
003
004
005

Jun
Jun
Jun
Jun
Jun

N010996

005

Jun 04, 1982

ASPIRIN; PENTAZOCINE HYDROCHLORIDE

TABLET; ORAL
TALWIN COMPOUND
SANOFI AVENTIS US

325MG;EQ 12.5MG BASE

ASPIRIN; PRAVASTATIN SODIUM

TABLET, TABLET; ORAL
PRAVIGARD PAC (COPACKAGED)
BRISTOL MYERS SQUIBB 325MG,N/A;N/A,80MG
TABLET, TABLET, TABLET; ORAL
PRAVIGARD PAC (COPACKAGED)
BRISTOL MYERS SQUIBB 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

24,
24,
24,
24,
24,

2003
2003
2003
2003
2003

ASPIRIN; PROPOXYPHENE HYDROCHLORIDE

CAPSULE; ORAL
DARVON W/ ASA
XANODYNE PHARM

325MG;65MG

ASPIRIN; PROPOXYPHENE NAPSYLATE

CAPSULE; ORAL
DARVON-N W/
AAIPHARMA
TABLET; ORAL
DARVON-N W/
AAIPHARMA

ASA
LLC

325MG;100MG

N016829

001

ASA
LLC

325MG;100MG

N016863

001

0.5MG/ML

N019058

001

Sep 13, 1989

25MG
50MG
100MG
50MG
100MG
50MG
100MG
25MG
50MG
100MG
25MG

A076907
A076907
A076907
A073317
A073318
A074127
A074127
A074101
A074101
A074101
A074265

001
002
003
001
001
001
002
001
002
003
001

Jul
Jul
Jul
Mar
Mar
Feb
Feb
Jul
Jul
Jul
Feb

ATENOLOL
INJECTABLE; INJECTION
TENORMIN
ASTRAZENECA
TABLET; ORAL
ATENOLOL
ABLE

APOTHECON
NOSTRUM LABS
PLIVA

SANDOZ

30,
30,
30,
20,
20,
21,
21,
17,
17,
17,
28,

2004
2004
2004
1992
1992
1995
1995
1997
1997
1997
1994

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DISCONTINUED DRUG PRODUCT LIST

6 - 36 (of 346)

ATENOLOL
TABLET; ORAL
ATENOLOL
SANDOZ
SCS
TEVA
TEVA PHARMS

50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG

A074265
A074265
A073676
A073676
A073315
A073316
A074120
A074120

002
003
001
002
001
001
001
002

Feb
Feb
Oct
Oct
May
May
Feb
Feb

28,
28,
30,
30,
28,
28,
24,
24,

1994
1994
1992
1992
1993
1993
1995
1995

A074404
A074404
A074107
A074107

001
002
001
002

May
May
Sep
Sep

14,
14,
24,
24,

1998
1998
1997
1997

A078940
A078940
A078940
A078940
A078940
A078940
A078940

001
002
003
004
005
006
007

Aug
Aug
Aug
Aug
Aug
Aug
Aug

30,
30,
30,
30,
30,
30,
30,

2010
2010
2010
2010
2010
2010
2010

N021411

001

Nov 26, 2002

N020259

001

Nov 25, 1992

A074824
A074753
A074632
A074740
A074945
A074784

001
001
001
001
001
001

Sep
Jan
Dec
Mar
Jul
Jun

30,
23,
23,
28,
28,
11,

1997
1997
1996
1997
1998
1997

A074825
A074768
A074633
A074639
A074741
A074944

001
001
001
001
001
001

Sep
Jan
Dec
Mar
Mar
Jul

30,
23,
23,
25,
28,
28,

1997
1997
1996
1997
1997
1998

N018831

002

Jun 20, 1985

N018831

001

Nov 23, 1983

A071295

001

Jan 30, 1987

ATENOLOL; CHLORTHALIDONE
TABLET; ORAL
ATENOLOL AND CHLORTHALIDONE
NOSTRUM LABS
50MG;25MG
100MG;25MG
PLIVA
50MG;25MG
100MG;25MG

ATOMOXETINE HYDROCHLORIDE
CAPSULE; ORAL
ATOMOXETINE HYDROCHLORIDE
ACTAVIS ELIZABETH
10MG
18MG
25MG
40MG
60MG
80MG
100MG
STRATTERA
LILLY
5MG

ATOVAQUONE
TABLET; ORAL
MEPRON
GLAXOSMITHKLINE LLC

250MG

ATRACURIUM BESYLATE
INJECTABLE; INJECTION
ATRACURIUM BESYLATE
BAXTER HLTHCARE
BAXTER HLTHCARE CORP
HOSPIRA

10MG/ML
10MG/ML
10MG/ML
10MG/ML
MARSAM PHARMS LLC
10MG/ML
TEVA PARENTERAL
10MG/ML
ATRACURIUM BESYLATE PRESERVATIVE FREE
BAXTER HLTHCARE
10MG/ML
BAXTER HLTHCARE CORP 10MG/ML
HOSPIRA
10MG/ML
10MG/ML
10MG/ML
MARSAM PHARMS LLC
10MG/ML
TRACRIUM
HOSPIRA
10MG/ML
TRACRIUM PRESERVATIVE FREE
HOSPIRA
10MG/ML

ATROPINE
INJECTABLE; INJECTION
ATROPINE
SOLVAY

EQ 2MG SULFATE/0.7ML

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ATROPINE SULFATE
AEROSOL, METERED; INHALATION
ATROPINE SULFATE
US ARMY
EQ 0.36MG BASE/INH

N020056

001

Sep 19, 1990

N017744

001

A086440

001

A085735

001

A085746

001

A085737

001

A085266

001

A040395
A087934
A086798
A085509
A086727
A085659
A086950
A085506
A087131
A085766
A085035
A086057
A086173
A087842
A087195
A085876
A087765

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Nov 27, 2000

Jul 19, 1983

A088962

001

May 10, 1985

A088009

001

Mar 25, 1983

A085211

001

N019677

001

Nov 06, 1991

A087853
A087847
A087848

001
001
001

Nov 26, 1982

Nov 26, 1982
Nov 26, 1982

A085121
A085121

001
002

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
0.025MG;2.5MG
SOLUTION; ORAL
COLONAID
MEDPOINTE PHARM HLC
0.025MG/5ML;2.5MG/5ML
LOMANATE
ALPHARMA US PHARMS
0.025MG/5ML;2.5MG/5ML
TABLET; ORAL
COLONAID
MEDPOINTE PHARM HLC
0.025MG;2.5MG
DI-ATRO
MD PHARM
0.025MG;2.5MG
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ABLE
0.025MG;2.5MG
ASCOT
0.025MG;2.5MG
HEATHER
0.025MG;2.5MG
INWOOD LABS
0.025MG;2.5MG
IVAX PHARMS
0.025MG;2.5MG
KV PHARM
0.025MG;2.5MG
LEDERLE
0.025MG;2.5MG
MUTUAL PHARM
0.025MG;2.5MG
PARKE DAVIS
0.025MG;2.5MG
PVT FORM
0.025MG;2.5MG
R AND S PHARMA
0.025MG;2.5MG
ROXANE
0.025MG;2.5MG
SANDOZ
0.025MG;2.5MG
USL PHARMA
0.025MG;2.5MG
VALEANT PHARM INTL
0.025MG;2.5MG
WATSON LABS
0.025MG;2.5MG
WEST WARD
0.025MG;2.5MG
LOGEN
SUPERPHARM
0.025MG;2.5MG
LO-TROL
VANGARD
0.025MG;2.5MG
LOW-QUEL
HALSEY
0.025MG;2.5MG

Mar 29, 1982

Feb 16, 1982
Mar 15, 1982

ATROPINE SULFATE; EDROPHONIUM CHLORIDE

INJECTABLE; INJECTION
ENLON-PLUS
MYLAN INSTITUTIONAL

0.14MG/ML;10MG/ML

ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE

INJECTABLE; INJECTION
ATROPINE AND DEMEROL
ABBOTT

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

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ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE

INJECTABLE; INJECTION
MEPERIDINE AND ATROPINE SULFATE
WYETH AYERST
0.4MG/ML;100MG/ML

A085121

003

N021175

001

N017601

001

N018506

001

25MG

N016324

002

EQ 100MG BASE/VIAL

N017391

001

EQ 0.125MG BASE/SPRAY

N022203

001

Oct 15, 2008

EQ 250MG BASE

N050670

001

Nov 01, 1991

N050762

001

Dec 18, 1998

A062388
A062417
N050562
A062388
A062417
N050562
A062388
A062417
N050562

001
001
001
002
002
002
003
003
003

Sep
Oct
Sep
Sep
Oct
Sep
Sep
Oct
Sep

N050580

001

Dec 31, 1986

ATROPINE; PRALIDOXIME CHLORIDE

INJECTABLE; INTRAMUSCULAR
ATNAA
US ARMY
2.1MG/0.7ML;600MG/0.7ML

Jan 17, 2002

AZATADINE MALEATE
TABLET; ORAL
OPTIMINE
SCHERING

1MG

AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE; ORAL
TRINALIN
SCHERING
1MG;120MG

Mar 23, 1982

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

AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE

FOR SUSPENSION, TABLET; ORAL
TROVAN/ZITHROMAX COMPLIANCE PAK
PFIZER
EQ 1GM BASE,N/A;N/A,EQ 100MG BASE

AZLOCILLIN SODIUM
INJECTABLE; INJECTION
AZLIN
BAYER PHARMS

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

2GM
2GM
2GM
3GM
3GM
3GM
4GM
4GM
4GM

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

08,
12,
03,
08,
12,
03,
08,
12,
03,

1982
1982
1982
1982
1982
1982
1982
1982
1982

AZTREONAM
INJECTABLE; INJECTION
AZACTAM
BRISTOL MYERS SQUIBB

500MG/VIAL

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AZTREONAM
INJECTABLE; INJECTION
AZACTAM IN PLASTIC CONTAINER
BRISTOL MYERS SQUIBB 10MG/ML

N050632

003

May 24, 1989

125MG/5ML

N050556

001

Mar 23, 1982

400MG
800MG

N050520
N050520

001
002

Sep 12, 1983

A060282

001

A060734

001

A060687
A062158
A062453

001
001
001

Mar 28, 1984

A062799
A062857

001
001

May 14, 1987

Nov 13, 1987

A061699
A062456

001
001

Jul 27, 1983

A061737

001

BACAMPICILLIN HYDROCHLORIDE
FOR SUSPENSION; ORAL
SPECTROBID
PFIZER
TABLET; ORAL
SPECTROBID
PFIZER

BACITRACIN
INJECTABLE; INJECTION
BACITRACIN
PFIZER
50,000 UNITS/VIAL
OINTMENT; OPHTHALMIC
BACIGUENT
PHARMACIA AND UPJOHN 500 UNITS/GM
BACITRACIN
LILLY
500 UNITS/GM
PHARMADERM
500 UNITS/GM
PHARMAFAIR
500 UNITS/GM
OINTMENT; TOPICAL
BACITRACIN
COMBE
500 UNITS/GM
NASKA
500 UNITS/GM
POWDER; FOR RX COMPOUNDING
BACITRACIN
APOTHEKERNES
5,000,000 UNITS/BOT
PADDOCK LLC
5,000,000 UNITS/BOT

BACITRACIN ZINC
POWDER; FOR RX COMPOUNDING

ZIBA-RX

X GEN PHARMS
500,000 UNITS/BOT

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC

CORTISPORIN

MONARCH PHARMS

400 UNITS/GM;1%;EQ 3.5MG

N050416
BASE/GM;10,000 UNITS/GM

ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE

PHARMAFAIR
400 UNITS/GM;1%;EQ 3.5MG
A062389
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
A062381
UNITS/GM

002

001

Jul 02, 1982

001

Sep 06, 1985

A062499

001

Jun 03, 1985

A062386

001

Sep 09, 1982

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

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6 - 40 (of 346)

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC

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

MONARCH PHARMS
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

A062167

001

A060647

001

N050417

001

A062833

001

Nov 09, 1987

N050167

002

Mar 01, 1985

A062430

001

Apr 08, 1983

A061229

001

A062849

001

BACITRACIN ZINC; POLYMYXIN B SULFATE

AEROSOL; TOPICAL
POLYSPORIN
GLAXOSMITHKLINE
10,000 UNITS/GM;2,000,000 UNITS/GM
OINTMENT; OPHTHALMIC
OCUMYCIN
PHARMAFAIR
500 UNITS/GM;10,000 UNITS/GM
POLYSPORIN
MONARCH PHARMS
500 UNITS/GM;10,000 UNITS/GM
OINTMENT; TOPICAL
BACITRACIN ZINC-POLYMYXIN B SULFATE
NASKA
500 UNITS/GM;10,000 UNITS/GM

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 UNITS/GM

A060731

002

A061048

001

500 UNITS/GM;5,000 UNITS/GM

N050598

001

Sep 22, 1986

10MG
20MG
10MG
20MG
10MG
10MG
20MG
20MG

A073043
A073044
A071260
A071261
A073092
A074698
A073093
A074698

001
001
001
001
001
001
001
002

Feb
Feb
May
May
Jan
Aug
Jan
Aug

N017851
N017851

001
003

Jan 20, 1982

N021589
N021589

001
002

Oct 30, 2003

Oct 30, 2003

BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT; OPHTHALMIC

MYCITRACIN

PHARMACIA AND UPJOHN

500 UNITS/GM;EQ 3.5MG BASE/GM;10,000

UNITS/GM

BACITRACIN; POLYMYXIN B SULFATE

DISC; TOPICAL
LANABIOTIC
COMBE

BACLOFEN
TABLET; ORAL
BACLOFEN
TEVA
USL PHARMA
WATSON LABS

LIORESAL
NOVARTIS

10MG
20MG
TABLET, ORALLY DISINTEGRATING; ORAL
KEMSTRO
SCHWARZ PHARMA
10MG
20MG

27,
27,
06,
06,
28,
20,
28,
20,

1992
1992
1988
1988
1994
1996
1994
1996

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6 - 41 (of 346)

BECLOMETHASONE DIPROPIONATE
AEROSOL, METERED; INHALATION
BECLOVENT
GLAXOSMITHKLINE
0.042MG/INH
VANCERIL
SCHERING
0.042MG/INH
VANCERIL DOUBLE STRENGTH
SCHERING
0.084MG/INH
AEROSOL, METERED; NASAL
BECONASE
GLAXOSMITHKLINE
0.042MG/INH
VANCENASE
SCHERING
0.042MG/INH

N018153

001

N017573

001

N020486

001

N018584

001

N018521

001

N019589
N020469

001
001

Dec 23, 1987

Jun 26, 1996

A076476
A076476
A076476
A076476

001
002
003
004

Feb
Feb
Feb
Feb

10MG

N012164

003

2.5MG

N012164

001

5MG

N012164

002

A084149

001

N018366

001

N012427

003

EQ 50MG BASE/VIAL

N016820

001

EQ 100MG BASE

N016818

006

Dec 24, 1996

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

SPRAY, METERED; NASAL
VANCENASE AQ
SCHERING

EQ 0.042MG DIPROP/SPRAY
EQ 0.084MG DIPROP/SPRAY

BENAZEPRIL HYDROCHLORIDE
TABLET; ORAL
BENAZEPRIL HYDROCHLORIDE
GENPHARM
5MG
10MG
20MG
40MG

11,
11,
11,
11,

2004
2004
2004
2004

BENDROFLUMETHIAZIDE
TABLET; ORAL
NATURETIN-10
APOTHECON
NATURETIN-2.5
APOTHECON
NATURETIN-5
APOTHECON

BENOXINATE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
BENOXINATE HYDROCHLORIDE
SOLA BARNES HIND
0.4%

BENTIROMIDE
SOLUTION; ORAL
CHYMEX
SAVAGE LABS

500MG/7.5ML

BENZPHETAMINE HYDROCHLORIDE
TABLET; ORAL
DIDREX
PHARMACIA AND UPJOHN

25MG

BENZQUINAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION

EMETE-CON

PFIZER
SUPPOSITORY; RECTAL

EMETE-CON

ROERIG

Dec 29, 1983

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BENZTHIAZIDE
TABLET; ORAL
AQUATAG
SOLVAY
BENZTHIAZIDE
PVT FORM
EXNA
AH ROBINS INC
FOVANE
PFIZER
URESE
PFIZER

25MG
50MG

N016001
N016001

001
002

50MG

A083206

001

50MG

N012489

001

50MG

N012128

002

25MG

N012128

003

0.5MG
1MG
2MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG

A040699
A040705
A040706
A081264
A081265
A088514
A088510
A088511
A089211
A089212
A089213

001
001
001
001
001
001
001
001
001
001
001

0.5MG
1MG
2MG

N009193
N009193
N009193

004
003
002

50%

A084535

001

200MG
300MG
400MG

N019001
N019001
N019001

001
002
003

Dec 28, 1990

Dec 28, 1990
Dec 28, 1990

200MG
300MG
400MG

N019002
N019002
N019002

001
002
003

Dec 28, 1990

Dec 28, 1990
Dec 28, 1990

30MG

N017589

001

0.2%

N014762

001

0.6MG

N012657

003

BENZTROPINE MESYLATE
TABLET; ORAL
BENZTROPINE MESYLATE
ACTAVIS TOTOWA

MUTUAL PHARM
QUANTUM PHARMICS

USL PHARMA

COGENTIN
MERCK

Feb
Feb
Feb
Jan
Jan
Jan
Jan
Jan
Jun
Jun
Jun

14,
14,
14,
23,
23,
31,
31,
31,
14,
14,
14,

2008
2008
2008
1992
1992
1984
1984
1984
1988
1988
1988

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
TABLET; ORAL
CELESTONE
SCHERING

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BETAMETHASONE BENZOATE
CREAM; TOPICAL
UTICORT
PARKE DAVIS
GEL; TOPICAL
UTICORT
PARKE DAVIS
LOTION; TOPICAL
UTICORT
PARKE DAVIS
OINTMENT; TOPICAL
UTICORT
PARKE DAVIS

0.025%

N016998

002

0.025%

N017244

001

0.025%

N017528

001

0.025%

N018089

001

N019138

001

Jun 26, 1984

A072536
A074579
N019136
A071143
A071476

001
001
001
001
001

Jan
Nov
Jun
Jun
Aug

N017536

001

N019408

001

N017829

001

N019408

002

Nov 22, 1991

A070273

001

Aug 12, 1985

A071085
A070274
A072276
A074272
A071882

001
001
001
001
001

Feb
Aug
Aug
Sep
Jun

N017781

001

N019143

001

Sep 04, 1984

A072526
N019140
A071477

001
001
001

Jan 31, 1990

Sep 04, 1984
Aug 10, 1987

N017691

001

A085738

001

N017561

001

BETAMETHASONE DIPROPIONATE
CREAM; TOPICAL
ALPHATREX
SAVAGE LABS
EQ 0.05% BASE
BETAMETHASONE DIPROPIONATE
PERRIGO NEW YORK
EQ 0.05% BASE
EQ 0.05% BASE
PHARMADERM
EQ 0.05% BASE
TARO
EQ 0.05% BASE
TEVA
EQ 0.05% BASE
DIPROSONE
SCHERING
EQ 0.05% BASE
CREAM, AUGMENTED; TOPICAL
DIPROLENE
SCHERING
EQ 0.05% BASE
DISC; TOPICAL
DIPROSONE
SCHERING
EQ 0.1% BASE
GEL, AUGMENTED; TOPICAL
DIPROLENE
SCHERING
EQ 0.05% BASE
LOTION; TOPICAL
ALPHATREX
SAVAGE LABS
EQ 0.05% BASE
BETAMETHASONE DIPROPIONATE
ALPHARMA US PHARMS
EQ 0.05% BASE
PHARMADERM
EQ 0.05% BASE
TARO
EQ 0.05% BASE
EQ 0.05% BASE
TEVA PHARMS
EQ 0.05% BASE
DIPROSONE
SCHERING
EQ 0.05% BASE
OINTMENT; TOPICAL
ALPHATREX
SAVAGE LABS
EQ 0.05% BASE
BETAMETHASONE DIPROPIONATE
PERRIGO NEW YORK
EQ 0.05% BASE
PHARMADERM
EQ 0.05% BASE
TEVA
EQ 0.05% BASE
DIPROSONE
SCHERING
EQ 0.05% BASE

BETAMETHASONE SODIUM PHOSPHATE

INJECTABLE; INJECTION
BETAMETHASONE SODIUM PHOSPHATE
WATSON LABS
EQ 3MG BASE/ML
CELESTONE
SCHERING
EQ 3MG BASE/ML

31,
26,
26,
17,
10,

1990
1997
1984
1987
1987

Jan 31, 1986

03,
12,
24,
30,
06,

1987
1985
1988
1994
1988

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DISCONTINUED DRUG PRODUCT LIST

6 - 44 (of 346)

BETAMETHASONE VALERATE
CREAM; TOPICAL
BETADERM
ROACO
BETAMETHASONE VALERATE
PERRIGO NEW YORK
PHARMADERM
PHARMAFAIR
TARO
BETATREX
SAVAGE LABS
VALISONE
SCHERING
LOTION; TOPICAL
BETAMETHASONE VALERATE
PHARMADERM
PHARMAFAIR
TEVA PHARMS
BETATREX
SAVAGE LABS
VALISONE
SCHERING
OINTMENT; TOPICAL
BETAMETHASONE VALERATE
PERRIGO NEW YORK
PHARMADERM
PHARMAFAIR
BETATREX
SAVAGE LABS
BETA-VAL
TEVA
VALISONE
SCHERING

EQ 0.1% BASE

N018839

001

Jun 30, 1983

EQ
EQ
EQ
EQ

BASE
BASE
BASE
BASE

A070053
N018860
A070485
A070062

001
002
001
001

Jun
Aug
May
May

EQ 0.1% BASE

N018862

001

Aug 31, 1983

EQ 0.01% BASE
EQ 0.1% BASE

N016322
N016322

002
001

EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE

N018870
A070484
A071883

001
001
001

Aug 31, 1983

May 29, 1987
Apr 22, 1988

EQ 0.1% BASE

N018867

001

Aug 31, 1983

EQ 0.1% BASE

N016932

001

EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE

A071478
N018864
A070486

001
001
001

Dec 23, 1987

Aug 31, 1983
May 29, 1987

EQ 0.1% BASE

N018863

001

Aug 31, 1983

EQ 0.1% BASE

A070069

001

Dec 19, 1985

EQ 0.1% BASE

N016740

001

10MG
20MG

N019507
N019507

001
002

Oct 27, 1989

Oct 27, 1989

N019807
N019807

001
002

Oct 30, 1992

Oct 30, 1992

N020619

001

Apr 17, 1997

50MG/ML

N009344

001

5MG/ML

N006536

001

0.1%
0.1%
0.1%
0.1%

10,
31,
29,
14,

1986
1983
1987
1985

BETAXOLOL HYDROCHLORIDE
TABLET; ORAL
KERLONE
SANOFI AVENTIS US

BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE

TABLET; ORAL
KERLEDEX
SANOFI AVENTIS US

5MG;12.5MG
10MG;12.5MG

BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE

SUSPENSION/DROPS; OPHTHALMIC
BETOPTIC PILO
ALCON
EQ 0.25% BASE;1.75%

BETAZOLE HYDROCHLORIDE
INJECTABLE; INJECTION
HISTALOG
LILLY

BETHANECHOL CHLORIDE
INJECTABLE; INJECTION
URECHOLINE
ODYSSEY PHARMS

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DISCONTINUED DRUG PRODUCT LIST

6 - 45 (of 346)

BETHANECHOL CHLORIDE
TABLET; ORAL
BETHANECHOL CHLORIDE
ABLE

ACTAVIS TOTOWA

ASCOT
IVAX SUB TEVA PHARMS
LANNETT

SANDOZ

WATSON LABS

MYOTONACHOL
GLENWOOD

URECHOLINE
ODYSSEY PHARMS

5MG
10MG
25MG
50MG
5MG
10MG
25MG
50MG
10MG
25MG
25MG
5MG
10MG
25MG
5MG
10MG
10MG
25MG
25MG
5MG
5MG
5MG
10MG
10MG
10MG
25MG
25MG
25MG
50MG
50MG

A040492
A040483
A040485
A040509
A040552
A040553
A040554
A040551
A088288
A088289
A084689
A084702
A084712
A084074
A084353
A084378
A084379
A084383
A084384
A084402
A085230
A085841
A084408
A085228
A085842
A084441
A085229
A085839
A087397
A087444

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001

5MG
10MG
25MG

A084188
A084188
A084188

001
003
004

5MG
10MG
25MG
50MG

N006536
N006536
N006536
N006536

003
002
004
005

10MG
25MG

N017675
N017675

001
002

5MG/ML

N012418

002

Jul
Jul
Jul
Jul
Oct
Oct
Oct
Oct
Jun
Jun

27,
27,
27,
27,
28,
28,
28,
28,
08,
08,

2004
2004
2004
2004
2004
2004
2004
2004
1983
1983

BETHANIDINE SULFATE
TABLET; ORAL
TENATHAN
ROBINS AH

BIPERIDEN LACTATE
INJECTABLE; INJECTION
AKINETON
ABBOTT

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 N021551
;N/A,5.6GM

002

Sep 24, 2007

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DISCONTINUED DRUG PRODUCT LIST

6 - 46 (of 346)

BISOPROLOL FUMARATE
TABLET; ORAL
BISOPROLOL FUMARATE
MUTUAL PHARM

5MG
10MG

A075474
A075474

001
002

Oct 25, 2002

Oct 25, 2002

A075672
A075672
A075672
A075642
A075642
A075642
A075632
A075632
A075632
A075527
A075527
A075527
A075686
A075686
A075686

001
002
003
002
001
003
001
002
003
001
003
002
001
002
003

Sep
Sep
Sep
Dec
Dec
Dec
Sep
Sep
Sep
Sep
Sep
Sep
Jan
Jan
Jan

N018770

001

Dec 28, 1984

N019548

001

Feb 19, 1992

EQ 15 UNITS BASE/VIAL
EQ 30 UNITS BASE/VIAL

N050443
N050443

001
002

Sep 07, 1995

EQ 15 UNITS BASE/VIAL
EQ 30 UNITS BASE/VIAL

A064084
A064084

001
002

Jun 01, 1996

Jun 01, 1996

A070134
A071298
A071151
A071152
A071153
A070545
A070546
N019030
N019033
A070119
A070891

001
001
001
001
001
001
001
001
001
001
001

Apr
Feb
Aug
Aug
Aug
May
May
Apr
Apr
Apr
Jul

N019005
N019005
N019005

002
003
001

Apr 29, 1986

Apr 29, 1986
Apr 29, 1986

N019837
N019837

002
001

Apr 12, 1989

Apr 12, 1989

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ACTAVIS ELIZABETH
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
APOTHECON
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
IVAX SUB TEVA PHARMS 2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
SANDOZ
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG
TEVA
2.5MG;6.25MG
5MG;6.25MG
10MG;6.25MG

25,
25,
25,
27,
27,
27,
27,
27,
27,
25,
25,
25,
19,
19,
19,

2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2001
2001
2001

BITOLTEROL MESYLATE
AEROSOL, METERED; INHALATION
TORNALATE
SANOFI AVENTIS US
0.37MG/INH
SOLUTION; INHALATION
TORNALATE
SANOFI AVENTIS US
0.2%

BLEOMYCIN SULFATE
INJECTABLE; INJECTION
BLENOXANE
BRISTOL MYERS SQUIBB
BLEOMYCIN SULFATE
TEVA PARENTERAL

BRETYLIUM TOSYLATE
INJECTABLE; INJECTION
BRETYLIUM TOSYLATE
ABRAXIS PHARM

50MG/ML
100MG/ML
ASTRAZENECA
50MG/ML
50MG/ML
50MG/ML
BAXTER HLTHCARE
50MG/ML
50MG/ML
HOSPIRA
50MG/ML
50MG/ML
INTL MEDICATION
50MG/ML
LUITPOLD
50MG/ML
BRETYLIUM TOSYLATE IN DEXTROSE 5%
ABBOTT
200MG/100ML
400MG/100ML
800MG/100ML
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
200MG/100ML
400MG/100ML

29,
13,
10,
10,
10,
14,
14,
29,
29,
29,
26,

1986
1987
1987
1987
1987
1986
1986
1986
1986
1986
1988

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6 - 47 (of 346)

BRETYLIUM TOSYLATE
INJECTABLE; INJECTION
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA INC
200MG/100ML
400MG/100ML
800MG/100ML
BRETYLOL
HOSPIRA
50MG/ML

N019008
N019008
N019008

002
003
001

Apr 29, 1986

Apr 29, 1986
Apr 29, 1986

N017954

001

N020613
N020490

001
001

Sep 06, 1996

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

2MG/5ML
2MG/5ML
2MG/5ML
2MG/5ML

A086936
A085466
A087517
A087964

001
001
001
001

Jan 25, 1983

10MG/ML
100MG/ML

A083821
A083820

001
001

10MG/ML

N011418

002

4MG
4MG
4MG
4MG
4MG
4MG
4MG

A084468
A084351
A086987
A086187
A087009
A088604
A083215

001
001
001
001
001
001
001

BRIMONIDINE TARTRATE
SOLUTION/DROPS; OPHTHALMIC
ALPHAGAN
ALLERGAN
0.2%
0.5%
BRIMONIDINE TARTRATE
TEVA PARENTERAL
0.2%

BROMFENAC SODIUM
SOLUTION/DROPS; OPHTHALMIC
XIBROM
ISTA PHARMS INC
0.09%

BROMOCRIPTINE MESYLATE
CAPSULE; ORAL
BROMOCRIPTINE MESYLATE
LEK PHARM

EQ 5MG BASE

BROMODIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL
AMBODRYL
PARKE DAVIS

25MG

BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE

SYRUP; ORAL
AMBENYL
FOREST LABS
12.5MG/5ML;10MG/5ML
BROMANYL
ALPHARMA US PHARMS
12.5MG/5ML;10MG/5ML
BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE
WOCKHARDT
12.5MG/5ML;10MG/5ML

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

Jul 13, 1984

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6 - 48 (of 346)

BROMPHENIRAMINE MALEATE
TABLET; ORAL
BROMPHENIRAMINE MALEATE
VITARINE
4MG
WATSON LABS
4MG
4MG
DIMETANE
WYETH CONS
4MG
TABLET, EXTENDED RELEASE; ORAL
DIMETANE
WYETH CONS
8MG
12MG

A085850
A083123
A085769

001
001
001

N010799

003

N010799
N010799

010
011

Jun 10, 1983

Jun 10, 1983

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
BROMFED-DM
WOCKHARDT
DIMETANE-DX
ROBINS AH

2MG/5ML;10MG/5ML;30MG/5ML

A088722

001

Mar 07, 1985

2MG/5ML;10MG/5ML;30MG/5ML

A089681

001

Dec 22, 1988

2MG/5ML;10MG/5ML;30MG/5ML

N019279

001

Aug 24, 1984

4MG/5ML;25MG/5ML

A088687

001

Sep 26, 1984

4MG/5ML;25MG/5ML

A088688

001

Feb 06, 1985

2MG/5ML;12.5MG/5ML
ORAL

N013087

003

Mar 29, 1984

12MG;75MG

A071099

001

Jul 02, 1987

12MG;75MG

N012436

003

May 14, 1985

N019672

001

Mar 29, 1996

N010911

006

N020233

001

Feb 14, 1994

N020441

003

Jun 24, 1997

BROMPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

ELIXIR; ORAL
BIPHETAP
MORTON GROVE
BROMANATE
ALPHARMA US PHARMS
DIMETAPP
WYETH CONS
TABLET, EXTENDED RELEASE;
BROMATAPP
COPLEY PHARM
DIMETAPP
WYETH CONS

BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL
EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE
ALZA
16MG;240MG

BUCLIZINE HYDROCHLORIDE
TABLET; ORAL
BUCLADIN-S
STUART PHARMS

50MG

BUDESONIDE
AEROSOL, METERED; NASAL

RHINOCORT

ASTRAZENECA
0.032MG/INH
POWDER, METERED; INHALATION
PULMICORT
ASTRAZENECA
0.32MG/INH

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6 - 49 (of 346)

BUDESONIDE
SPRAY, METERED; NASAL
RHINOCORT
ASTRAZENECA

0.064MG/INH

N020746

002

Oct 01, 1999

0.25MG/ML
0.25MG/ML

A074160
A074613

001
001

Oct 30, 1997

Nov 18, 1997

0.25MG/ML

N018226

001

Feb 28, 1983

0.5MG
1MG
2MG

N018225
N018225
N018225

002
001
003

Feb 28, 1983

Feb 28, 1983
Jun 14, 1985

N019978
N019978
N019978

001
002
003

Sep 03, 1992

Sep 03, 1992
Sep 03, 1992

A071166
A071169
A071171

001
001
001

Jun 16, 1988

Jun 16, 1988
Jun 16, 1988

N021496

001

May 23, 2003

A075613
A075613

002
001

Oct 10, 2000

Oct 10, 2000

N018644

001

Dec 30, 1985

A076845
A076834
A076845

001
001
002

Jul 14, 2005

Jul 14, 2005
Jul 14, 2005

N020358

001

Oct 04, 1996

N020711

002

May 14, 1997

N021190
N021190
N021190
N021190

001
002
003
004

Dec
Dec
Dec
Dec

BUMETANIDE
INJECTABLE; INJECTION
BUMETANIDE
HOSPIRA
TEVA PARENTERAL
BUMEX
VALIDUS PHARMS INC
TABLET; ORAL
BUMEX
VALIDUS PHARMS INC

BUPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION

BUPIVACAINE HYDROCHLORIDE KIT

HOSPIRA
0.075%
0.114%
0.23%

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

BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION
DUOCAINE
AMPHASTAR PHARMS INC

EQ 0.375% (37.5MG/10ML);EQ 1%
(100MG/10ML)

BUPROPION HYDROCHLORIDE
TABLET; ORAL
BUPROPION HYDROCHLORIDE
SANDOZ
75MG
100MG
WELLBUTRIN
GLAXOSMITHKLINE
50MG
TABLET, EXTENDED RELEASE; ORAL
BUPROPION HYDROCHLORIDE
SANDOZ
100MG
150MG
150MG
WELLBUTRIN SR
GLAXOSMITHKLINE
50MG
ZYBAN
GLAXOSMITHKLINE
100MG

BUSPIRONE HYDROCHLORIDE
CAPSULE; ORAL

BUSPAR

BRISTOL MYERS SQUIBB 5MG

7.5MG
10MG
15MG

20,
20,
20,
20,

2000
2000
2000
2000

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DISCONTINUED DRUG PRODUCT LIST

6 - 50 (of 346)

BUSPIRONE HYDROCHLORIDE
TABLET; ORAL
BUSPAR
BRISTOL MYERS SQUIBB

5MG
10MG
15MG
30MG

N018731
N018731
N018731
N018731

001
002
003
004

Sep
Sep
Apr
Apr

29,
29,
22,
22,

1986
1986
1996
1996

BUSPIRONE HYDROCHLORIDE
ACTAVIS TOTOWA
5MG
10MG
15MG
30MG
IVAX SUB TEVA PHARMS 5MG
10MG
15MG
SANDOZ
5MG
10MG
15MG

A075388
A075388
A075388
A078302
A075385
A075385
A075385
A075413
A075413
A075413

001
002
003
001
001
002
003
001
002
003

May
May
May
Dec
Mar
Mar
Mar
Mar
Mar
Mar

09,
09,
09,
17,
01,
01,
01,
19,
19,
19,

2002
2002
2002
2007
2002
2002
2002
2002
2002
2002

15MG
30MG
50MG
100MG

A085381
A085381
A085381
A085381

001
002
003
004

30MG/5ML

A085873

001

30MG/5ML

A085383

001

33.3MG/5ML

A085880

001

30MG/5ML

A084723

001

30MG

A085550

001

15MG
15MG
30MG
30MG
16.2MG
32.4MG
48.6MG
97.2MG
15MG
30MG
15MG
30MG
15MG
30MG

A084292
A085938
A084272
A085934
A083606
A083898
A083897
A083896
A088632
A088631
A085764
A085772
A083325
A083337

003
001
002
001
001
001
001
001
001
001
001
001
002
001

15MG
100MG

N000793
N000793

002
005

15MG

A084719

001

30MG

A084719

002

15MG
30MG

A083484
A084040

001
001

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

Feb 09, 1982

May 18, 1985

May 01, 1985

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DISCONTINUED DRUG PRODUCT LIST

6 - 51 (of 346)

BUTABARBITAL SODIUM
TABLET; ORAL
SODIUM BUTABARBITAL
LANNETT

MARSHALL PHARMA
WEST WARD

15MG
30MG
100MG
16.2MG
32.4MG
15MG
30MG

A085849
A085866
A085881
A083524
A083858
A085418
A085432

001
001
001
001
001
001
001

2%

N019215

001

Nov 25, 1985

100MG

N019359

001

Nov 25, 1985

A075342
A075559
A075342
A075559

001
001
002
002

Nov
Mar
Nov
Mar

04,
20,
04,
20,

1999
2000
1999
2000

A074620
A075170
A074620
A075170

001
001
002
002

Jan
Sep
Jan
Sep

22,
28,
22,
28,

1997
1998
1997
1998

N019890

001

Dec 12, 1991

N020664

001

Dec 23, 1996

100MG;2MG

N009000

002

100MG;1MG

N006620

001

100MG;1MG

A086562

001

0.02MG
0.05MG

N018312
N018312

001
002

0.005%

N020273

001

BUTOCONAZOLE NITRATE
CREAM; VAGINAL
FEMSTAT
ROCHE PALO
SUPPOSITORY; VAGINAL
FEMSTAT
ROCHE PALO

BUTORPHANOL TARTRATE
INJECTABLE; INJECTION
BUTORPHANOL TARTRATE
HOSPIRA

1MG/ML
1MG/ML
2MG/ML
2MG/ML
BUTORPHANOL TARTRATE PRESERVATIVE FREE
HOSPIRA
1MG/ML
1MG/ML
2MG/ML
2MG/ML
SPRAY, METERED; NASAL
STADOL
BRISTOL MYERS SQUIBB 1MG/SPRAY

CABERGOLINE
TABLET; ORAL
DOSTINEX
PHARMACIA AND UPJOHN

0.5MG

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 PHARM

Dec 29, 1993

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DISCONTINUED DRUG PRODUCT LIST

6 - 52 (of 346)

CALCITONIN HUMAN
INJECTABLE; INJECTION
CIBACALCIN
NOVARTIS

0.5MG/VIAL

N018470

001

Oct 31, 1986

200 IU/ML
400 IU/VIAL

N017769
N017497

001
001

200 IU/ML

A073690

001

Apr 14, 1995

100 IU/ML

N017808

001

Jul 03, 1986

0.001MG/ML
0.002MG/ML
0.001MG/ML

A075816
A075816
A075823

001
002
001

Jan 16, 2004

Jan 16, 2004
Mar 31, 2003

EQ 84.5MG CALCIUM
EQ 169MG CALCIUM

N021160
N021160

001
002

Apr 02, 2001

Apr 02, 2001

EQ 169MG CALCIUM

A077693

001

Jan 30, 2008

EQ 169MG CALCIUM

N019976

001

Dec 10, 1990

N021823

001

Aug 12, 2005

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
FRESENIUS MEDCL

CALCIUM CARBONATE; RISEDRONATE SODIUM

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

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

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6 - 53 (of 346)

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
00ML;330MG/100ML;88MG/100ML

001

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;

SODIUM CHLORIDE; SODIUM CITRATE
INJECTABLE; INJECTION
ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
35MG/100ML;5GM/100ML;30MG/100ML;74MG/10 N018269
0ML;640MG/100ML;500MG/100ML;74MG/100ML

002

Jan 17, 1983

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
/100ML;560MG/100ML
DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
B BRAUN
29MG/100ML;1.5GM/100ML;15MG/100ML;610MG N018460
/100ML;560MG/100ML
DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
B BRAUN
29MG/100ML;4.25GM/100ML;15MG/100ML;610M N018460
G/100ML;560MG/100ML

006

Jan 29, 1986

001

003

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 N018460
/100ML;390MG/100ML
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN
26MG/100ML;5GM/100ML;5MG/100ML;530MG/10 N018460
0ML;450MG/100ML
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
B BRAUN
26MG/100ML;4.25GM/100ML;15MG/100ML;560M N018460
G/100ML;390MG/100ML

002

008

Jan 29, 1986

004

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 N018256
00ML

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
ML;62MG/100ML
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN
20MG/100ML;5GM/100ML;30MG/100ML;600MG/1
00ML;310MG/100ML
MILES
20MG/100ML;5GM/100ML;30MG/100ML;600MG/1
00ML;310MG/100ML
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN
HOSPIRA
20MG/100ML;5GM/100ML;104MG/100ML;600MG/
100ML;310MG/100ML
20MG/100ML;5GM/100ML;179MG/100ML;600MG/
100ML;310MG/100ML
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN
HOSPIRA
20MG/100ML;5GM/100ML;254MG/100ML;600MG/
100ML;310MG/100ML
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN
HOSPIRA
20MG/100ML;5GM/100ML;254MG/100ML;600MG/
100ML;310MG/100ML

N019634

002

N017510

001

N018499

001

Feb 24, 1988

PLASTIC CONTAINER
N019685 005
Oct 17, 1988
N019685

006

Oct 17, 1988

PLASTIC CONTAINER
N019685 007
Oct 17, 1988
PLASTIC CONTAINER
N019685 003
Oct 17, 1988

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6 - 54 (of 346)

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE; INJECTION
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA
20MG/100ML;5GM/100ML;104MG/100ML;600MG/ N019685 001
Oct 17, 1988
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 N019395
8MG/100ML
INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;2.5GM/100ML;538MG/100ML;44 N019395
8MG/100ML
INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
FRESENIUS MEDCL
25.7MG/100ML;4.25GM/100ML;538MG/100ML;4 N019395
48MG/100ML

001

Mar 26, 1986

002

Mar 26, 1986

003

Mar 26, 1986

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
16.1MG/ML

001

Jun 16, 1986

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/ N018899
100ML;500MG/100ML;74MG/100ML

001

Oct 31, 1983

001

Nov 29, 1982

N018721

001

Nov 09, 1982

N018462

001

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 N018725
/100ML

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
ABBOTT
33MG/100ML;30MG/100ML;860MG/100ML

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE; INJECTION

LACTATED RINGER'S IN PLASTIC CONTAINER

20MG/100ML;30MG/100ML;600MG/100ML;310MG N019485
ABBOTT
/100ML
20MG/100ML;30MG/100ML;600MG/100ML;310MG N018023
B BRAUN
/100ML
20MG/100ML;30MG/100ML;600MG/100ML;310MG N018417
MILES
/100ML

001

Oct 24, 1985

001
001

CALCIUM GLUCEPTATE
INJECTABLE; INJECTION
CALCIUM GLUCEPTATE
ABBOTT
ABRAXIS PHARM
LILLY

EQ
EQ
EQ
EQ

90MG
90MG
90MG
90MG

CALCIUM/5ML
CALCIUM/5ML
CALCIUM/5ML
CALCIUM/5ML

A080001
A083159
A089373
N006470

001
001
001
001

Apr 30, 1987

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DISCONTINUED DRUG PRODUCT LIST

6 - 55 (of 346)

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

0.6MG/GM

A061596

001

3MG

A061613

001

37.5MG
75MG
150MG

N018343
N018343
N018343

006
007
004

Sep 17, 1986

Jun 13, 1995
Jun 13, 1995

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
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
12.5MG
25MG
25MG
50MG
50MG
100MG
100MG
12.5MG
25MG

A074472
A074472
A074472
A074472
A074423
A074423
A074423
A074423
A074748
A074748
A074748
A074748
A074418
A074418
A074418
A074418
A074590
A074590
A074590
A074590
A074493
A074493
A074493
A074493
A074640
A074640
A074640
A074640
A074481
A074519
A074481
A074519
A074481
A074519
A074481
A074519
A074433
A074433

001
002
003
004
001
002
003
004
004
002
001
003
001
002
003
004
004
002
001
003
001
002
003
004
001
002
003
004
001
001
002
002
003
003
004
004
001
002

Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
May
May
May
May
Feb
Feb
Feb
Feb
Aug
Aug
Aug
Aug
Feb
Feb
Feb
Feb
Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb

CANDICIDIN
OINTMENT; VAGINAL
VANOBID
SANOFI AVENTIS US
TABLET; VAGINAL
VANOBID
SANOFI AVENTIS US

CAPTOPRIL
TABLET; ORAL
CAPOTEN
PAR PHARM

CAPTOPRIL
APOTHECON

CLONMEL HLTHCARE

EGIS PHARMS

ENDO LABS

IVAX SUB TEVA PHARMS

PAR PHARM

PUREPAC PHARM

SANDOZ

TEVA

31,
31,
31,
31,
13,
13,
13,
13,
29,
29,
29,
29,
13,
13,
13,
13,
30,
30,
30,
30,
13,
13,
13,
13,
31,
31,
31,
31,
13,
13,
13,
13,
13,
13,
13,
13,
13,
13,

1995
1995
1995
1995
1996
1996
1996
1996
1997
1997
1997
1997
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1997
1997
1997
1997
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996

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DISCONTINUED DRUG PRODUCT LIST

6 - 56 (of 346)

CAPTOPRIL
TABLET; ORAL
CAPTOPRIL
TEVA
TEVA PHARMS

WATSON LABS

50MG
100MG
12.5MG
25MG
50MG
100MG
12.5MG
25MG
50MG
100MG

A074433
A074433
A074462
A074462
A074462
A074462
A074576
A074576
A074576
A074576

003
004
001
002
003
004
001
002
003
004

Feb
Feb
Feb
Feb
Feb
Feb
Apr
Apr
Apr
Apr

13,
13,
13,
13,
13,
13,
23,
23,
23,
23,

1996
1996
1996
1996
1996
1996
1996
1996
1996
1996

A074788
A074788
A074788
A074788
A075055
A075055
A075055
A075055
A074832

001
002
004
003
001
002
004
003
001

Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Dec

29,
29,
29,
29,
18,
18,
18,
18,
29,

1997
1997
1997
1997
1998
1998
1998
1998
1997

0.01%

A070292

001

May 21, 1986

0.01%

A073677

001

Apr 28, 1995

100MG/5ML

A075875

001

Dec 21, 2000

200MG
200MG
200MG
200MG
200MG

A071696
A070231
A071479
A070300
A070429

001
001
001
001
001

Nov
Aug
Jul
May
Jan

200MG

A076525

001

Sep 26, 2003

100MG

A071940

001

Feb 01, 1988

EQ
EQ
EQ
EQ
EQ

N050306
N050306
N050306
N050306
N050306

001
004
002
006
007

N050298
N050298
N050298

001
002
003

CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET; ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
ENDO LABS
25MG;15MG
25MG;25MG
50MG;15MG
50MG;25MG
IVAX SUB TEVA PHARMS 25MG;15MG
25MG;25MG
50MG;15MG
50MG;25MG
WATSON LABS
50MG;25MG

CARBACHOL
SOLUTION; INTRAOCULAR
CARBACHOL
PHARMAFAIR
CARBASTAT
NOVARTIS

CARBAMAZEPINE
SUSPENSION; ORAL
CARBAMAZEPINE
TARO
TABLET; ORAL
CARBAMAZEPINE
ACTAVIS ELIZABETH
INWOOD LABS
PLIVA
USL PHARMA
WARNER CHILCOTT
TERIL
TARO
TABLET, CHEWABLE; ORAL
CARBAMAZEPINE
JUBILANT CADISTA

CARBENICILLIN DISODIUM
INJECTABLE; INJECTION
GEOPEN
ROERIG

PYOPEN
GLAXOSMITHKLINE

1GM BASE/VIAL
2GM BASE/VIAL
5GM BASE/VIAL
10GM BASE/VIAL
30GM BASE/VIAL

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 5GM BASE/VIAL

09,
14,
24,
15,
02,

1987
1986
1987
1986
1987

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DISCONTINUED DRUG PRODUCT LIST

6 - 57 (of 346)

CARBENICILLIN DISODIUM
INJECTABLE; INJECTION
PYOPEN
GLAXOSMITHKLINE

EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL

N050298
N050298

006
007

N050435

001

A073586
A073587
A073620
A074080
A074080
A074080
A073381
A073382
A073383

001
001
001
001
002
003
001
001
001

Jun
Jun
Jun
Mar
Mar
Mar
Sep
Sep
Sep

A076663

001

Jun 24, 2004

A076643
A076643
A076643

001
002
003

Jun 10, 2005

Jun 10, 2005
Jun 10, 2005

4MG/5ML

N008955

001

4MG

N008915

001

50MG/VIAL
150MG/VIAL
450MG/VIAL

A076473
A076473
A076473

001
002
003

Oct 27, 2004

Oct 27, 2004
Oct 27, 2004

50MG/VIAL
150MG/VIAL
450MG/VIAL

N019880
N019880
N019880

001
002
003

Mar 03, 1989

Mar 03, 1989
Mar 03, 1989

A077247
A077247
A077096
A077096
A077096
A077389
A077389
A077389

001
002
001
002
003
001
002
003

Oct
Oct
Jun
Jun
Jun
Mar
Mar
Mar

N020452
N020452
N020452

001
002
003

Jul 14, 2003

Jul 14, 2003
Jul 14, 2003

CARBENICILLIN INDANYL SODIUM

TABLET; ORAL
GEOCILLIN
PFIZER

EQ 382MG BASE

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
KV PHARM
50MG;200MG
TABLET, FOR SUSPENSION; ORAL
CARBILEV
RANBAXY
10MG;100MG
25MG;100MG
25MG;250MG

29,
29,
29,
25,
25,
25,
28,
28,
28,

1995
1995
1995
1994
1994
1994
1993
1993
1993

CARBINOXAMINE MALEATE
ELIXIR; ORAL
CLISTIN
MCNEIL
TABLET; ORAL
CLISTIN
ORTHO MCNEIL PHARM

CARBOPLATIN
INJECTABLE; INJECTION
CARBOPLATIN
HOSPIRA

PARAPLATIN
BRISTOL MYERS SQUIBB

INJECTABLE; IV (INFUSION)
CARBOPLATIN
APP PHARMS
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
SAGENT PHARMS
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
TEVA PARENTERAL
50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)
PARAPLATIN
BRISTOL MYERS SQUIBB 50MG/5ML (10MG/ML)
150MG/15ML (10MG/ML)
450MG/45ML (10MG/ML)

21,
21,
14,
14,
14,
30,
30,
30,

2004
2004
2005
2005
2005
2007
2007
2007

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DISCONTINUED DRUG PRODUCT LIST

6 - 58 (of 346)

CARBOPLATIN
INJECTABLE; IV (INFUSION)
PARAPLATIN
BRISTOL MYERS SQUIBB 600MG/60ML (10MG/ML)

N020452

004

Jan 15, 2004

250MG

N011792

003

350MG
350MG
350MG
350MG
350MG
350MG
350MG

A040421
A089390
A081025
A089566
A040152
A085433
A086179

001
001
001
001
001
001
001

350MG

N012155

001

50MG/ML

N014173

001

12.5MG
25MG
50MG

N012768
N012768
N012768

001
002
004

100MG
150MG

N018550
N018550

002
003

Dec 31, 1987

Dec 31, 1987

2.5MG
5MG
10MG

N019204
N019204
N019204

001
002
003

Dec 28, 1988

Dec 28, 1988
Dec 28, 1988

EQ 250MG BASE
EQ 500MG BASE

N050521
N050521

001
002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

A062205
A062205
A064107
A064107
A064061
A064061
A064148
A064148
A064081
A064145
A064081
A064145

001
002
001
002
001
002
001
002
001
001
002
002

CARISOPRODOL
CAPSULE; ORAL
SOMA
MEDA PHARMS
TABLET; ORAL
CARISOPRODOL
ABLE
PIONEER PHARMS
SANDOZ
WATSON LABS

RELA
SCHERING

Jun
Oct
Apr
Aug
Dec

21,
13,
13,
30,
03,

2001
1988
1989
1988
1996

CARPHENAZINE MALEATE
CONCENTRATE; ORAL
PROKETAZINE
WYETH AYERST
TABLET; ORAL
PROKETAZINE
WYETH AYERST

CARPROFEN
TABLET; ORAL
RIMADYL
ROCHE

CARTEOLOL HYDROCHLORIDE
TABLET; ORAL
CARTROL
ABBOTT

CEFACLOR
CAPSULE; ORAL
CECLOR
LILLY
CEFACLOR
CEPH INTL
CLONMEL HLTHCARE
IVAX SUB TEVA PHARMS
MARSAM PHARMS LLC
TEVA

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

Apr
Apr
Apr
Apr
May
May
Sep
Jun
Sep
Jun

27,
27,
27,
27,
23,
23,
16,
24,
16,
24,

1995
1995
1995
1995
1996
1996
1996
1996
1996
1996

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DISCONTINUED DRUG PRODUCT LIST

6 - 59 (of 346)

CEFACLOR
FOR SUSPENSION; ORAL
CECLOR
LILLY

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

N050522
N050522

001
002

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A064114
A064115
A064116
A064110
A062206
A062206
A062206
A062206
A064087
A064086
A064085
A064070
A064204
A064205
A064206
A064207

001
001
001
001
001
003
002
004
001
001
001
001
001
001
001
001

Apr
Apr
Apr
Apr
Apr
Feb
Feb
Feb
Feb

BASE
BASE

N050673
N050673

001
002

Jun 28, 1996

Jun 28, 1996

BASE

A065057

001

Jan 05, 2001

EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE

A062766
A063017
A062695

001
001
001

Mar 03, 1987

Jan 05, 1989
Feb 10, 1989

EQ 250MG BASE
EQ 500MG BASE

N050512
N050512

002
001

EQ 500MG BASE

A062378

001

Mar 16, 1982

EQ
EQ
EQ
EQ
EQ
EQ

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A062334
A062334
A062334
A062698
A062698
A062698

001
002
003
001
002
003

Mar 01, 1989

Mar 01, 1989
Mar 01, 1989

EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML

N050527
N050527
N050527

002
003
001

EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML

A062376
A062376
A062376

001
002
003

EQ 1GM BASE

N050528

001

EQ 1GM BASE
EQ 1GM BASE

A062390
A062408

001
001

CEFACLOR
CLONMEL HLTHCARE

EQ 125MG
EQ 187MG
EQ 250MG
EQ 375MG
FACTA FARMA
EQ 125MG
EQ 187MG
EQ 250MG
EQ 375MG
IVAX SUB TEVA PHARMS EQ 125MG
EQ 187MG
EQ 250MG
EQ 375MG
MARSAM PHARMS LLC
EQ 125MG
EQ 187MG
EQ 250MG
EQ 375MG
TABLET, EXTENDED RELEASE; ORAL
CECLOR CD
LILLY
EQ 375MG
EQ 500MG
CEFACLOR
WORLD GEN
EQ 500MG

Apr
Apr
Apr
Apr

28,
28,
28,
28,

1995
1995
1995
1995

Apr 20, 1988

20,
28,
28,
28,
28,
18,
18,
18,
18,

1988
1995
1995
1995
1995
1998
1998
1998
1998

CEFADROXIL/CEFADROXIL HEMIHYDRATE
CAPSULE; ORAL
CEFADROXIL
IVAX SUB TEVA PHARMS
PUREPAC PHARM
TEVA
DURICEF
WARNER CHILCOTT
ULTRACEF
BRISTOL
FOR SUSPENSION; ORAL
CEFADROXIL
APOTHECON

TEVA

DURICEF
WARNER CHILCOTT

ULTRACEF
BRISTOL

TABLET; ORAL
DURICEF
WARNER CHILCOTT
ULTRACEF
APOTHECON
BRISTOL

125MG
250MG
500MG
125MG
250MG
500MG

Mar 16, 1982

Mar 16, 1982
Mar 16, 1982

Jun 10, 1982

Aug 31, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 60 (of 346)

CEFAMANDOLE NAFATE
INJECTABLE; INJECTION
MANDOL
LILLY

EQ
EQ
EQ
EQ
EQ
EQ

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

N050504
A062560
N050504
A062560
N050504
N050504

001
001
002
002
003
004

N050461
N050461
N050461
N050461
N050461

001
002
003
004
005

N050566
N050566

003
004

Jun 08, 1983

Jun 08, 1983

N050566
N050566

001
002

Jun 08, 1983

Jun 08, 1983

N050779

001

Jul 27, 2000

A062688
A062688
A062688
A062688
A062894
A062894
A062894
A062894
A062894
A062807
A062807
A062807
A062807
A062807
A062807
A064033
A062988
A062988
A062988
A062989
A062989
A062989
A063016
A063016
A063016
A063018
A063018

002
003
004
005
001
002
003
004
005
001
002
003
004
005
006
001
001
002
003
001
002
003
001
002
003
001
002

Nov
Nov
Nov
Aug
Jul
Jul
Jul
Jul
Jul
Jan
Jan
Jan
Jan
Jan
Jan
Oct
Dec
Dec
Dec
Dec
Dec
Dec
Mar
Mar
Mar
Mar
Mar

A061773
A061773
A062557
A062557

001
005
001
002

Sep 08, 1987

Sep 10, 1985
Sep 10, 1985

Sep 10, 1985

Sep 10, 1985

CEFAZOLIN SODIUM
INJECTABLE; INJECTION
ANCEF
GLAXOSMITHKLINE

EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
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
BAXTER HLTHCARE
EQ 10MG BASE/ML
EQ 20MG BASE/ML
CEFAZOLIN AND DEXTROSE
B BRAUN
EQ 500MG BASE/VIAL
CEFAZOLIN SODIUM
ABRAXIS PHARM
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
BEDFORD
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
ELKINS SINN
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
GLAXOSMITHKLINE
EQ 1GM BASE/VIAL
MARSAM PHARMS LLC
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
TEVA
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
KEFZOL
ACS DOBFAR
EQ 250MG BASE/VIAL
EQ 20GM BASE/VIAL
LILLY
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL

17,
17,
17,
03,
21,
21,
21,
21,
21,
12,
12,
12,
12,
12,
12,
31,
29,
29,
29,
29,
29,
29,
14,
14,
14,
05,
05,

1986
1986
1986
1987
1988
1988
1988
1988
1988
1988
1988
1988
1988
1988
1988
1993
1989
1989
1989
1989
1989
1989
1989
1989
1989
1990
1990

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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6 - 61 (of 346)

CEFDINIR
CAPSULE; ORAL
OMNICEF
ABBOTT
FOR SUSPENSION; ORAL
OMNICEF
ABBOTT

300MG

N050739

001

Dec 04, 1997

125MG/5ML
250MG/5ML

N050749
N050749

001
002

Dec 04, 1997

Jul 29, 2004

100MG/5ML

N050622

001

Apr 28, 1989

200MG
400MG

N050621
N050621

001
002

Apr 28, 1989

Apr 28, 1989

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

N050571
N050571
N050571

001
002
003

Dec 30, 1987

Dec 30, 1987
Dec 30, 1987

N050637
N050637

001
002

Dec 11, 1989

Dec 11, 1989

N050683
N050683

001
002

Dec 29, 1992

Dec 29, 1992

N050579
A063295
N050579
N050579
N050579

001
001
002
003
004

May
Jul
May
May
May

23,
26,
23,
23,
23,

1984
1993
1984
1984
1984

A063333
N050551
A063333
N050551
N050551

001
001
002
002
003

Mar
Nov
Mar
Nov
Mar

31,
18,
31,
18,
05,

1995
1982
1995
1982
1990

N050613
N050613

002
001

Jul 31, 1987

Jul 23, 1986

A062579
A062579
A062579
A062579
A062579

001
002
003
004
005

Nov
Nov
Nov
Nov
Nov

CEFIXIME
FOR SUSPENSION; ORAL
SUPRAX
LEDERLE
TABLET; ORAL
SUPRAX
LEDERLE

CEFMENOXIME HYDROCHLORIDE
INJECTABLE; INJECTION
CEFMAX
TAP PHARM

CEFMETAZOLE SODIUM
INJECTABLE; INJECTION
ZEFAZONE
PHARMACIA AND UPJOHN

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
ZEFAZONE IN PLASTIC CONTAINER
PHARMACIA AND UPJOHN EQ 20MG BASE/ML
EQ 40MG BASE/ML

CEFONICID SODIUM
INJECTABLE; INJECTION
MONOCID
GLAXOSMITHKLINE

EQ
EQ
EQ
EQ
EQ

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

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
PFIZER
EQ 20MG BASE/ML
EQ 40MG BASE/ML

CEFORANIDE
INJECTABLE; INJECTION
PRECEF
APOTHECON

500MG/VIAL
1GM/VIAL
2GM/VIAL
10GM/VIAL
20GM/VIAL

26,
26,
26,
26,
26,

1984
1984
1984
1984
1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 62 (of 346)

CEFORANIDE
INJECTABLE; INJECTION
PRECEF
BRISTOL

500MG/VIAL
1GM/VIAL
2GM/VIAL
10GM/VIAL
20GM/VIAL

N050554
N050554
N050554
N050554
N050554

001
002
003
004
005

May
May
May
May
May

24,
24,
24,
24,
24,

1984
1984
1984
1984
1984

N050792

001

Jul 29, 2004

N050792

002

Jul 29, 2004

N050596
N050596

001
003

May 20, 1985

May 20, 1985

A063293
N050588
A063293
N050588
N050588

001
001
002
002
003

Apr
Dec
Apr
Dec
Apr

N050694
N050694

002
001

Jul 30, 1993

Jul 30, 1993

N050601

001

Dec 30, 1988

A062757
A062757
N050517
N050517
N050517

001
002
001
002
003

Jan 08, 1987

Jan 08, 1987

N050581
N050581

003
004

Sep 20, 1984

Sep 20, 1984

N050581
N050581

002
001

Sep 20, 1984

Sep 20, 1984

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL

N050633
N050633
N050633

002
003
005

Jan 31, 1989

Jan 31, 1989
Jan 31, 1989

EQ 50MG BASE/5ML
EQ 100MG BASE/5ML

N050688
N050688

002
001

Aug 07, 1992

Aug 07, 1992

CEFOTAXIME SODIUM
INJECTABLE; INJECTION
CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
B BRAUN
EQ 2GM BASE
CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
B BRAUN
EQ 1GM BASE
CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
SANOFI AVENTIS US
EQ 20MG BASE/ML
EQ 40MG BASE/ML

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
ASTRAZENECA
EQ 20MG BASE/ML
EQ 40MG BASE/ML

29,
27,
29,
27,
25,

1993
1985
1993
1985
1988

CEFOTIAM HYDROCHLORIDE
INJECTABLE; INJECTION
CERADON
TAKEDA

EQ 1GM BASE/VIAL

CEFOXITIN SODIUM
INJECTABLE; INJECTION
MEFOXIN
BIONICHE PHARMA
MYLAN

MEFOXIN
MERCK
MEFOXIN
MERCK

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
INSTITUTIONAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
IN DEXTROSE 5% IN PLASTIC CONTAINER
EQ 20MG BASE/ML
EQ 40MG BASE/ML
IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
EQ 20MG BASE/ML
EQ 40MG BASE/ML

CEFPIRAMIDE SODIUM
INJECTABLE; INJECTION
CEFPIRAMIDE SODIUM
WYETH AYERST

CEFPODOXIME PROXETIL
FOR SUSPENSION; ORAL
BANAN
SANKYO

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 63 (of 346)

CEFPODOXIME PROXETIL
FOR SUSPENSION; ORAL
VANTIN
PHARMACIA AND UPJOHN
TABLET; ORAL
BANAN
SANKYO
VANTIN
PHARMACIA AND UPJOHN

EQ 50MG BASE/5ML
EQ 100MG BASE/5ML

N050675
N050675

001
002

Aug 07, 1992

Aug 07, 1992

EQ 100MG BASE
EQ 200MG BASE

N050687
N050687

001
002

Aug 07, 1992

Aug 07, 1992

EQ 100MG BASE
EQ 200MG BASE

N050674
N050674

001
002

Aug 07, 1992

Aug 07, 1992

125MG/5ML
250MG/5ML

N050665
N050665

001
002

Dec 23, 1991

Dec 23, 1991

250MG
500MG

N050664
N050664

001
002

Dec 23, 1991

Dec 23, 1991

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

N050646
N050646
N050646
N050646

001
002
003
004

Sep
Sep
Sep
Sep

27,
27,
27,
27,

1990
1990
1990
1990

1GM/VIAL
1GM/VIAL
2GM/VIAL
2GM/VIAL
6GM/VIAL
10GM/VIAL

A063322
A064006
A063322
A064006
A064008
A064008

001
001
002
002
001
002

Nov
Mar
Nov
Mar
Mar
Mar

07,
31,
07,
31,
31,
31,

1995
1992
1995
1992
1992
1992

A062655
A062655

001
002

Nov 20, 1985

Nov 20, 1985

A062739
A062739

001
002

Jul 10, 1986

Jul 10, 1986

A063221
A063221
A063221

001
002
003

Apr 29, 1993

Apr 29, 1993
Apr 29, 1993

N050634

001

Apr 28, 1989

EQ 180MG BASE/5ML

N050686

002

Dec 20, 1995

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

N050560
A063294

001
002

Sep 15, 1983

Mar 31, 1994

CEFPROZIL
FOR SUSPENSION; ORAL
CEFZIL
BRISTOL MYERS SQUIBB
TABLET; ORAL
CEFZIL
BRISTOL MYERS SQUIBB

CEFTAZIDIME
INJECTABLE; INJECTION
CEPTAZ
GLAXOSMITHKLINE

PENTACEF
GLAXOSMITHKLINE

TAZIDIME
LILLY

1GM/VIAL
2GM/VIAL
TAZIDIME IN PLASTIC CONTAINER
LILLY
1GM/VIAL
2GM/VIAL

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
GLAXOSMITHKLINE
EQ 10MG BASE/ML

CEFTIBUTEN DIHYDRATE
FOR SUSPENSION; ORAL
CEDAX
PERNIX THERAP

CEFTIZOXIME SODIUM
INJECTABLE; INJECTION
CEFIZOX
ASTELLAS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 64 (of 346)

CEFTIZOXIME SODIUM
INJECTABLE; INJECTION
CEFIZOX
ASTELLAS

N050560
A063294
N050560
N050560

002
003
003
005

Sep
Mar
Sep
Mar

N050589
N050589

001
002

Oct 03, 1984

Oct 03, 1984

N050589
N050589

003
004

Apr 13, 1995

Apr 13, 1995

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

N050585
N050585
N050585

002
003
004

Dec 21, 1984

Dec 21, 1984
Dec 21, 1984

EQ 250MG BASE/VIAL

N050585

001

Dec 21, 1984

EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
ROCHE
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
HOFFMANN LA ROCHE
EQ 10MG BASE/ML
EQ 20MG BASE/ML
EQ 40MG BASE/ML

A063239
A062654
A062654
A062654
N050585
A062510
A062510
A062510

001
001
002
003
005
001
002
003

Aug
Apr
Apr
Apr
Dec
Mar
Mar
Mar

N050624
N050624
N050624

001
002
003

Feb 11, 1987

Feb 11, 1987
Feb 11, 1987

EQ 500MG BASE/VIAL,N/A;N/A,1%
EQ 1GM BASE/VIAL,N/A;N/A,1%

N050585
N050585

007
006

May 08, 1996

May 08, 1996

EQ 250MG BASE
EQ 500MG BASE

A065126
A065126

001
002

Oct 28, 2003

Oct 28, 2003

EQ 750MG BASE/VIAL

A064035

001

Feb 26, 1993

EQ 750MG BASE/VIAL

A062591

001

Jan 10, 1986

EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL

A064035
A064036

002
001

Feb 26, 1993

Feb 26, 1993

EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL

A062591
A062591

002
003

Jan 10, 1986

Dec 17, 1987

CEFIZOX IN
ASTELLAS
CEFIZOX IN
ASTELLAS

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
DEXTROSE 5% IN PLASTIC CONTAINER
EQ 20MG BASE/ML
EQ 40MG BASE/ML
PLASTIC CONTAINER
EQ 20MG BASE/ML
EQ 40MG BASE/ML

15,
31,
15,
19,

1983
1994
1983
1993

CEFTRIAXONE SODIUM
INJECTABLE; ******
ROCEPHIN
HOFFMANN LA ROCHE

INJECTABLE; IM-IV
ROCEPHIN
HOFFMANN LA ROCHE
INJECTABLE; INJECTION
ROCEPHIN
HOFFMANN LA ROCHE

13,
30,
30,
30,
21,
12,
12,
12,

1993
1987
1987
1987
1984
1985
1985
1985

CEFTRIAXONE SODIUM; LIDOCAINE

INJECTABLE; INJECTION
ROCEPHIN KIT
HOFFMANN LA ROCHE

CEFUROXIME AXETIL
TABLET; ORAL
CEFUROXIME AXETIL
SANDOZ

CEFUROXIME SODIUM
INJECTABLE; IM-IV
CEFUROXIME SODIUM
MARSAM PHARMS LLC
KEFUROX
ACS DOBFAR
INJECTABLE; INJECTION
CEFUROXIME SODIUM
MARSAM PHARMS LLC
KEFUROX
ACS DOBFAR

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DISCONTINUED DRUG PRODUCT LIST

6 - 65 (of 346)

CEFUROXIME SODIUM
INJECTABLE; INJECTION
KEFUROX
LILLY
EQ 1.5GM
KEFUROX IN PLASTIC CONTAINER
LILLY
EQ 1.5GM
INJECTABLE; INTRAVENOUS
KEFUROX
LILLY
EQ 750MG
KEFUROX IN PLASTIC CONTAINER
LILLY
EQ 750MG

BASE/VIAL

A062592

002

Jan 10, 1986

BASE/VIAL

A062590

002

Jan 10, 1986

BASE/VIAL

A062592

001

Jan 10, 1986

BASE/VIAL

A062590

001

Jan 10, 1986

2.5GM/PACKET
300GM/BOT

N018757
N018757

002
003

Dec 28, 1982

Oct 16, 1984

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A062973
A063063
A063186
A062974
A063063
A063186
A062773
A062775
A061969
A061969
A062809
A062809
A062869
A062760
A062821
A062761
A062823
A062872
A062871

001
001
001
001
002
002
001
001
001
002
001
002
001
001
001
001
001
001
001

Nov
Sep
Dec
Nov
Sep
Dec
Jun
Apr

08,
29,
30,
23,
29,
30,
26,
22,

1988
1989
1994
1988
1989
1994
1987
1987

Apr
Apr
Mar
Apr
Feb
Apr
Feb
Jun
Jul

22,
22,
17,
24,
05,
24,
05,
20,
05,

1987
1987
1988
1987
1988
1987
1988
1988
1988

EQ 333MG BASE

N050405

004

May 12, 2006

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A062986
A062987
A062778
A062777
A062117
A062767
A062873
A062768
A062867
A062779
A062781

001
001
001
001
001
001
001
001
001
001
001

Apr
Jul
Aug
Aug

18,
25,
06,
06,

1991
1989
1987
1987

Jun
May
Jun
Apr
Dec
Dec

16,
23,
16,
15,
22,
22,

1987
1988
1987
1988
1987
1987

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

N050406
N050406
N050406

003
001
002

EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE

A062826
A062827
A062863

001
001
001

CELLULOSE SODIUM PHOSPHATE

POWDER; ORAL
CALCIBIND
MISSION PHARMA

CEPHALEXIN
CAPSULE; ORAL
CEPHALEXIN
APOTHECON

BARR
IVAX SUB TEVA PHARMS
PUREPAC PHARM
STEVENS J
TEVA

YOSHITOMI
KEFLEX
SHIONOGI INC
FOR SUSPENSION; ORAL
CEPHALEXIN
APOTHECON
BARR
FACTA FARMA
TEVA

VITARINE
KEFLEX
LEX PHARMS

TABLET; ORAL
CEPHALEXIN
BARR
VITARINE

250MG
250MG
250MG
500MG
500MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
500MG
250MG
250MG
500MG
500MG
250MG
500MG

125MG
250MG
125MG
250MG
100MG
125MG
125MG
250MG
250MG
125MG
250MG

Aug 17, 1987

Aug 17, 1987
Aug 11, 1988

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6 - 66 (of 346)

CEPHALEXIN
TABLET; ORAL
CEPHALEXIN
VITARINE

EQ 500MG BASE
EQ 1GM BASE

A062863
A062863

002
003

Aug 11, 1988

Aug 11, 1988

250MG BASE
250MG BASE
500MG BASE
500MG BASE
1GM BASE

A062745
N050440
A062745
N050440
N050440

001
003
002
001
002

Dec 01, 1986

Feb 26, 1987
Dec 01, 1986

125MG BASE
250MG BASE

A065100
A065100

002
001

Sep 11, 2003

Sep 11, 2003

EQ 250MG BASE
EQ 333MG BASE
EQ 500MG BASE

N050614
N050614
N050614

001
003
002

Oct 29, 1987

May 16, 1988
Oct 29, 1987

250MG

N050219

001

EQ
EQ
EQ
EQ

A062426
A062426
A062426
A062426

001
002
003
004

May
May
May
May

03,
03,
03,
03,

1985
1985
1985
1985

A062547
A062548
A062547
A062548
A062666
A062666
A062464
A062464
A062464

001
001
002
002
002
001
001
002
003

Sep
Sep
Sep
Sep
Jun
Jun
May
May
May

11,
11,
11,
11,
10,
10,
07,
07,
07,

1985
1985
1985
1985
1987
1987
1984
1984
1984

A062422
A062422
A062730
A062422
A062422
A062730

003
005
001
004
006
002

Jan
Jul
Mar
Jan
Jul
Mar

31,
16,
05,
31,
16,
05,

1984
1991
1987
1984
1991
1987

A062422
A062422

001
002

Jan 31, 1984

Jan 31, 1984

N050482
N050482
N050482
N050482

001
002
003
007

A062549
A062549

001
002

KEFLET
LILLY

EQ
EQ
EQ
EQ
EQ
TABLET, FOR SUSPENSION; ORAL
PANIXINE DISPERDOSE
RANBAXY LABS LTD
EQ
EQ

CEPHALEXIN HYDROCHLORIDE
TABLET; ORAL
KEFTAB
LILLY

CEPHALOGLYCIN
CAPSULE; ORAL
KAFOCIN
LILLY

CEPHALOTHIN SODIUM
INJECTABLE; INJECTION
CEPHALOTHIN
INTL MEDICATION

CEPHALOTHIN SODIUM
ABBOTT

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

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

Sep 10, 1985

Sep 10, 1985

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6 - 67 (of 346)

CEPHALOTHIN SODIUM
INJECTABLE; INJECTION
SEFFIN
GLAXOSMITHKLINE

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL

A062435
A062435
A062435

001
002
003

Nov 15, 1983

Nov 15, 1983
Nov 15, 1983

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL
4GM BASE/VIAL
4GM BASE/VIAL
20GM BASE/VIAL

A062961
N050446
A061769
A062724
A062961
N050446
A061769
A062724
A062961
N050446
A061769
A062961
N050446
N050446

001
005
001
001
002
001
002
002
003
002
003
004
003
004

Sep 20, 1988

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL
20GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
20GM BASE/VIAL

A062723
A062723
A062723
A062723
A062723
A062720
A062720
A062720
A062720

001
002
003
004
005
001
002
003
004

Nov
Nov
Nov
Nov
Nov
Jul
Jul
Jul
Jul

17,
17,
17,
17,
17,
02,
02,
02,
02,

1986
1986
1986
1986
1986
1987
1987
1987
1987

250MG
500MG

A061859
A061859

001
002

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

A062850
A062851
A062762
A062762
A062683
A062683
A062813
A062813

001
001
001
002
001
002
001
002

Apr
Apr
Mar
Mar
Jan
Jan
Feb
Feb

22,
22,
06,
06,
09,
09,
25,
25,

1988
1988
1987
1987
1987
1987
1988
1988

250MG
500MG

A061764
A061764

001
002

250MG

N050548

001

500MG

N050548

002

125MG/5ML
250MG/5ML

A061866
A061866

001
002

125MG/5ML
250MG/5ML

A062858
A062859

001
001

CEPHAPIRIN SODIUM
INJECTABLE; INJECTION
CEFADYL
APOTHECON

CEPHAPIRIN SODIUM
ABRAXIS PHARM

BAXTER HLTHCARE

Dec 23, 1986

Sep 20, 1988

Dec 23, 1986

Sep 20, 1988

Sep 20, 1988

CEPHRADINE
CAPSULE; ORAL
ANSPOR
GLAXOSMITHKLINE
CEPHRADINE
BARR
IVAX SUB TEVA PHARMS
TEVA
VITARINE
VELOSEF
APOTHECON
VELOSEF '250'
ERSANA
VELOSEF '500'
ERSANA
FOR SUSPENSION; ORAL
ANSPOR
GLAXOSMITHKLINE
CEPHRADINE
BARR

May 19, 1988

May 19, 1988

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6 - 68 (of 346)

CEPHRADINE
FOR SUSPENSION; ORAL
CEPHRADINE
TEVA
VELOSEF '125'
APOTHECON
VELOSEF '250'
APOTHECON
INJECTABLE; INJECTION
VELOSEF
APOTHECON

TABLET; ORAL
VELOSEF
BRISTOL MYERS SQUIBB

125MG/5ML
250MG/5ML

A062693
A062693

001
002

Jan 09, 1987

Jan 09, 1987

125MG/5ML

A061763

001

250MG/5ML

A061763

002

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

A061976
A061976
A061976
A061976
A061976

001
002
004
003
005

1GM

N050530

001

0.05MG
0.1MG
0.2MG
0.3MG
0.4MG
0.8MG

N020740
N020740
N020740
N020740
N020740
N020740

001
002
003
004
005
006

0.02MG/ML

N018296

001

A078617

001

Feb 02, 2010

A090378

002

May 09, 2008

A090378

001

May 09, 2008

N020044

001

Aug 02, 1990

N018513

002

Jul 28, 1983

25MG/5ML

N012126

001

100MG

A060058

001

CERIVASTATIN SODIUM
TABLET; ORAL
BAYCOL
BAYER PHARMS

Jun
Jun
Jun
Jun
May
Jul

26,
26,
26,
26,
24,
24,

1997
1997
1997
1997
1999
2000

CERULETIDE DIETHYLAMINE
INJECTABLE; INJECTION
TYMTRAN
PHARMACIA AND UPJOHN

CETIRIZINE HYDROCHLORIDE
SYRUP; ORAL
CETIRIZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 5MG/5ML
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS MID ATLANTIC 5MG/5ML
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ACTAVIS MID ATLANTIC 5MG/5ML

CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL

FOR SUSPENSION; INTRATRACHEAL
EXOSURF NEONATAL
GLAXOSMITHKLINE
12MG/VIAL;108MG/VIAL;8MG/VIAL

CHENODIOL
TABLET; ORAL
CHENIX
SIGMA TAU

250MG

CHLOPHEDIANOL HYDROCHLORIDE
SYRUP; ORAL
ULO
3M

CHLORAMPHENICOL
CAPSULE; ORAL
AMPHICOL
FERRANTE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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6 - 69 (of 346)

CHLORAMPHENICOL
CAPSULE; ORAL
AMPHICOL
FERRANTE
CHLORAMPHENICOL
IVAX SUB TEVA PHARMS
CHLOROMYCETIN
PARKEDALE

250MG

A060058

002

250MG

A062247

001

50MG
100MG
250MG

A060591
A060591
A060591

001
003
002

A060851

001

N050183

001

N050143

001

N050153

001

A060133

001

A062439

001

N050156

001

A061187

001

A061648

001

A062042
A062628

001
001

Sep 25, 1985

A062437

001

Apr 14, 1983

N050091

001

A061645

001

A061220

001

A062171

001

N050205

001

A062301
N050152

001
001

A062406

001

A062278

001

N050155

001

MYCHEL
ARMENPHARM
250MG
CREAM; TOPICAL
CHLOROMYCETIN
PARKE DAVIS
1%
FOR SOLUTION; OPHTHALMIC
CHLOROMYCETIN
PARKEDALE
25MG/VIAL
INJECTABLE; INJECTION
CHLOROMYCETIN
PARKE DAVIS
250MG/ML
OINTMENT; OPHTHALMIC
CHLORAMPHENICOL
ALTANA
1%
CHLOROFAIR
PHARMAFAIR
1%
CHLOROMYCETIN
PARKEDALE
1%
CHLOROPTIC S.O.P.
ALLERGAN
1%
ECONOCHLOR
ALCON
1%
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%

Apr 21, 1983

Mar 31, 1982

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

Nov 09, 1982

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6 - 70 (of 346)

CHLORAMPHENICOL SODIUM SUCCINATE

INJECTABLE; INJECTION
MYCHEL-S
ANGUS

EQ 1GM BASE/VIAL

A060132

001

N050294

001

N050202

001

N050201

002

N050203

002

A061188

001

N017813

001

A085482
A085481
A085488

001
001
001

A085447
A085517
A085447
A085518
A085447
A085513

001
001
002
001
003
001

A085086
A084639
A085087

001
001
001

A087525
A087524
A087512
A085118
A085119
A085120
A085340
A085339
A084685

001
001
001
001
001
001
001
001
001

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

Sep 12, 1983

CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE; ORAL
A-POXIDE
ABBOTT

CHLORDIAZACHEL
RACHELLE

5MG
5MG
10MG
10MG
25MG
25MG

5MG
10MG
25MG
CHLORDIAZEPOXIDE HYDROCHLORIDE
ASCOT
5MG
10MG
25MG
FERRANTE
5MG
10MG
25MG
HALSEY
5MG
10MG
25MG

Jan 07, 1982

Jan 07, 1982
Jan 07, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 71 (of 346)

CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE; ORAL
CHLORDIAZEPOXIDE HYDROCHLORIDE
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
LIBRIUM
VALEANT PHARM INTL
5MG
10MG
25MG
LYGEN
ALRA
5MG
10MG
25MG
INJECTABLE; INJECTION
LIBRIUM
VALEANT PHARM INTL
100MG/AMP

A086213
A085113
A086212
A083741
A083742
A083570
A086892
A087234
A086876
A087037
A086893
A087231
A086217
A084886
A084601
A084887
A085163
A084598
A085164
A089533
A089558
A085155
A084939
A085144
A084706
A084700
A084705
A084678
A084919
A084041
A084920
A084679
A084823
A088987
A088986
A088988
A088705
A088706
A086494
A088707
A084644
A084645
A088129
A088010
A088130
A085014
A085000
A085294

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

N012249
N012249
N012249

002
001
003

A085107
A085009
A085108

001
001
001

N012301

001

Jul 15, 1988

Jul 15, 1988

Apr
Apr
Apr
Jan
Jan

25,
25,
25,
18,
18,

1985
1985
1985
1985
1985

Jan 18, 1985

Mar 28, 1983

Mar 28, 1983
Mar 28, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 72 (of 346)

CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED

TABLET; ORAL
MENRIUM 10-4
ROCHE
MENRIUM 5-2
ROCHE
MENRIUM 5-4
ROCHE

10MG;0.4MG

N014740

006

5MG;0.2MG

N014740

002

5MG;0.4MG

N014740

004

2.5%

N019421

001

Dec 17, 1985

4%

A072255

001

Apr 15, 1991

0.5%

A072292

001

Jan 28, 1992

4%

A070104

001

Jul 24, 1986

4%

N019490

001

Mar 27, 1987

4%

A073416

001

Mar 14, 2000

4%

N018423

001

4%

A072295

001

0.6-1.4mCi/ML

N017269

001

100MG
200MG

N011467
N011467

003
005

2%
3%

N009435
N009435

003
004

EQ 40MG BASE/ML

N006002

002

EQ
EQ
EQ
EQ
EQ

A087228
A080886
A087504
A087979
A088030

001
001
001
001
001

CHLORHEXIDINE GLUCONATE
SOLUTION; TOPICAL
EXIDINE
XTTRIUM
MICRODERM
J AND J
PREVACARE R
J AND J
STERI-STAT
MATRIX MEDCL
SPONGE; TOPICAL
CHLORHEXIDINE GLUCONATE
KENDALL IL
E-Z SCRUB
BECTON DICKINSON
HIBICLENS
MOLNLYCKE HLTH
MICRODERM
J AND J

Feb 28, 1991

CHLORMERODRIN HG-197
INJECTABLE; INJECTION
CHLORMERODRIN HG 197
BRACCO

CHLORMEZANONE
TABLET; ORAL
TRANCOPAL
SANOFI AVENTIS US

CHLOROPROCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
NESACAINE-MPF
APP PHARMS

CHLOROQUINE HYDROCHLORIDE
INJECTABLE; INJECTION
ARALEN HYDROCHLORIDE
SANOFI AVENTIS US

CHLOROQUINE PHOSPHATE
TABLET; ORAL
CHLOROQUINE PHOSPHATE
MD PHARM
PUREPAC PHARM
TEVA
WATSON LABS

150MG
150MG
150MG
150MG
300MG

BASE
BASE
BASE
BASE
BASE

Jan 13, 1982

Dec 21, 1982
Dec 21, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 73 (of 346)

CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE

TABLET; ORAL
ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE
SANOFI AVENTIS US
EQ 300MG BASE;EQ 45MG BASE

N014860

002

250MG
250MG
500MG
250MG
250MG
250MG
250MG
500MG
500MG

A085569
A086940
A086938
A085485
A085165
A085173
A086795
A084026
A086796

001
001
001
001
001
001
001
001
001

250MG
500MG

N011145
N011145

004
002

N016016

001

N016016

002

A070783
A070654

001
001

Nov 06, 1987

Nov 06, 1987

A088557
A088365

001
001

Dec 22, 1983

Dec 22, 1983

A084853
A088151

001
001

Jun 09, 1983

A087744
A087745

001
001

May 06, 1982

May 06, 1982

N011635

003

Aug 26, 1987

N011635

006

Aug 26, 1987

12MG

A084652

001

12MG
25MG
72MG

N008102
N011444
N016235

004
001
001

2%

N017594

001

CHLOROTHIAZIDE
TABLET; ORAL
CHLOROTHIAZIDE
ABC HOLDING
LEDERLE
SANDOZ
WATSON LABS

DIURIL
LUNDBECK INC

Aug 15, 1983

Sep 01, 1982
Aug 15, 1983

CHLOROTHIAZIDE; METHYLDOPA
TABLET; ORAL
ALDOCLOR-150
MERCK
150MG;250MG
ALDOCLOR-250
MERCK
250MG;250MG
METHYLDOPA AND CHLOROTHIAZIDE
PAR PHARM
150MG;250MG
250MG;250MG

CHLOROTHIAZIDE; RESERPINE
TABLET; ORAL
CHLOROTHIAZIDE AND RESERPINE
WEST WARD
250MG;0.125MG
500MG;0.125MG
CHLOROTHIAZIDE W/ RESERPINE
WATSON LABS
250MG;0.125MG
500MG;0.125MG
CHLOROTHIAZIDE-RESERPINE
MYLAN
250MG;0.125MG
500MG;0.125MG
DIUPRES-250
MERCK
250MG;0.125MG
DIUPRES-500
MERCK
500MG;0.125MG

CHLOROTRIANISENE
CAPSULE; ORAL
CHLOROTRIANISENE
BANNER PHARMACAPS
TACE
SANOFI AVENTIS US

CHLOROXINE
SHAMPOO; TOPICAL
CAPITROL
WESTWOOD SQUIBB

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 74 (of 346)

CHLORPHENESIN CARBAMATE
TABLET; ORAL
MAOLATE
PHARMACIA AND UPJOHN

400MG

N014217

002

A070797

001

N017369
N017369

001
002

A080821
A080797
A083593
A086096
A086095

001
001
001
001
001

N008826
N008794

001
001

A083733

001

A087520

001

N006921

006

A083381

001

A083078
A083062
A080938
A080809
A080779
A087164
A086941
A080700
A086519
A083243
A085104
A083753
A088556
A086306
A080786
A080626
A080961
A085837
A080696
A080791
A085139
A083787

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

N006921

002

A083629

001

A080846

001

N007638

001

CHLORPHENIRAMINE MALEATE
CAPSULE, EXTENDED RELEASE; ORAL
CHLORPHENIRAMINE MALEATE
SANDOZ
12MG
TELDRIN
GLAXOSMITHKLINE
8MG
12MG
INJECTABLE; INJECTION
CHLORPHENIRAMINE MALEATE
BEL MAR
10MG/ML
ELKINS SINN
10MG/ML
WATSON LABS
10MG/ML
10MG/ML
100MG/ML
CHLOR-TRIMETON
SCHERING PLOUGH
10MG/ML
100MG/ML
PYRIDAMAL 100
BEL MAR
100MG/ML
SYRUP; ORAL
CHLORPHENIRAMINE MALEATE
PHARM ASSOC
2MG/5ML
CHLOR-TRIMETON
SCHERING
2MG/5ML
TABLET; ORAL
ANTAGONATE
BAYER PHARMS
4MG
CHLORPHENIRAMINE MALEATE
ANABOLIC
4MG
BELL PHARMA
4MG
ELKINS SINN
4MG
IMPAX LABS
4MG
IVAX SUB TEVA PHARMS 4MG
KV PHARM
4MG
LEDERLE
4MG
MUTUAL PHARM
4MG
NEWTRON PHARMS
4MG
PANRAY
4MG
PHARMAVITE
4MG
PHARMERAL
4MG
PIONEER PHARMS
4MG
PUREPAC PHARM
4MG
PVT FORM
4MG
ROXANE
4MG
SANDOZ
4MG
VITARINE
4MG
WATSON LABS
4MG
4MG
4MG
WEST WARD
4MG
CHLOR-TRIMETON
SCHERING
4MG
KLOROMIN
HALSEY
4MG
PHENETRON
LANNETT
4MG
TABLET, EXTENDED RELEASE; ORAL
CHLOR-TRIMETON
SCHERING PLOUGH
8MG

Aug 12, 1988

Feb 10, 1982

Jul 13, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 75 (of 346)

CHLORPHENIRAMINE MALEATE
TABLET, EXTENDED RELEASE; ORAL
EFIDAC 24 CHLORPHENIRAMINE MALEATE
ALZA
16MG

N019746

002

Nov 18, 1994

A088681

001

Sep 29, 1987

A088940

001

Jan 26, 1989

N018793

001

Apr 25, 1985

N018794

001

Apr 23, 1985

N018099

001

A088359

001

N012152

004

N018809

001

May 07, 1984

N019613

001

Jun 13, 1986

N018556

001

May 14, 1984

N018115

001

N018935

001

Apr 15, 1985

N018747

001

Mar 06, 1986

N019428
N018844
N018843
A071455

001
001
001
001

Aug
Mar
Mar
Mar

N021369

001

Jun 21, 2004

N018928

001

Aug 14, 1985

N018050

001

Jan 04, 1984

N014696

001

CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL
CHLOROHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE
WATSON LABS
12MG;75MG
CHLORPHENIRAMINE MALEATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE
SANDOZ
12MG;75MG
COLD CAPSULE IV
GRAHAM DM
12MG;75MG
COLD CAPSULE V
GRAHAM DM
8MG;75MG
CONTAC 12 HOUR
GLAXOSMITHKLINE
8MG;75MG
DRIZE
ASCHER
12MG;75MG
ORNADE
GLAXOSMITHKLINE
12MG;75MG
PHENYLPROPANOLAMINE HYDROCHLORIDE W/ CHLORPHENIRAMINE MALEATE
CENT PHARMS
8MG;75MG
TABLET, EXTENDED RELEASE; ORAL
CONTAC
NOVARTIS
12MG;75MG
DEMAZIN
SCHERING PLOUGH
4MG;25MG
TRIAMINIC-12
NOVARTIS
12MG;75MG

Feb 13, 1986

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL
CODIMAL-L.A. 12
SCHWARZ PHARMA
12MG;120MG
ISOCLOR
FISONS
8MG;120MG
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
CENT PHARMS
8MG;120MG
GRAHAM DM
8MG;120MG
12MG;120MG
KV PHARM
12MG;120MG

02,
20,
18,
01,

1988
1985
1985
1989

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

SUSPENSION, EXTENDED RELEASE; ORAL
CODEPREX
UCB INC
EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML
PENNTUSS
FISONS
EQ 4MG MALEATE/5ML;EQ 10MG BASE/5ML

CHLORPHENIRAMINE POLISTIREX; PHENYLPROPANOLAMINE POLISTIREX

SUSPENSION, EXTENDED RELEASE; ORAL
CORSYM
UCB INC
EQ 4MG MALEATE/5ML;EQ 37.5MG HCL/5ML

CHLORPHENTERMINE HYDROCHLORIDE
TABLET; ORAL
PRE-SATE
PARKE DAVIS

EQ 65MG BASE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 76 (of 346)

CHLORPROMAZINE
SUPPOSITORY; RECTAL
THORAZINE
GLAXOSMITHKLINE

25MG
100MG

N009149
N009149

024
033

N011120
N011120
N011120
N011120
N011120

016
017
018
019
020

A086863
A040231
A040224
A087032
A087053

001
001
001
001
001

Dec 30, 1999

Jan 26, 1999
Jul 08, 1982

A088157
A088158

001
001

Apr 27, 1983

Apr 27, 1983

A080983
A080983

004
005

N009149
N009149

032
043

A084911
A089563
A080365
A085591
A080370

001
001
001
001
001

N009149

011

A086712

001

A083040

001

N009149

022

A084414
A084415
A084411
A084412
A084413
A083549
A083549
A083549
A083574
A083575
A085750
A085751
A085484
A085752
A085748
A084803

001
001
001
001
001
001
002
003
001
001
002
001
001
001
002
001

CHLORPROMAZINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
THORAZINE
GLAXOSMITHKLINE
30MG
75MG
150MG
200MG
300MG
CONCENTRATE; ORAL
CHLORPROMAZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 100MG/ML
PHARM ASSOC
30MG/ML
100MG/ML
WOCKHARDT
30MG/ML
100MG/ML
CHLORPROMAZINE HYDROCHLORIDE INTENSOL
ROXANE
30MG/ML
100MG/ML
SONAZINE
SANDOZ
30MG/ML
100MG/ML
THORAZINE
GLAXOSMITHKLINE
30MG/ML
100MG/ML
INJECTABLE; INJECTION
CHLORPROMAZINE HYDROCHLORIDE
ABRAXIS PHARM
25MG/ML
MARSAM PHARMS LLC
25MG/ML
WATSON LABS
25MG/ML
25MG/ML
WYETH AYERST
25MG/ML
THORAZINE
GLAXOSMITHKLINE
25MG/ML
SYRUP; ORAL
CHLORPROMAZINE HYDROCHLORIDE
ALPHARMA US PHARMS
10MG/5ML
SONAZINE
SANDOZ
10MG/5ML
THORAZINE
GLAXOSMITHKLINE
10MG/5ML
TABLET; ORAL
CHLORPROMAZINE HYDROCHLORIDE
ABBOTT
10MG
25MG
50MG
100MG
200MG
IVAX SUB TEVA PHARMS 10MG
25MG
50MG
100MG
200MG
KV PHARM
10MG
25MG
50MG
100MG
200MG
LEDERLE
10MG

Apr 15, 1988

Jan 04, 1982

Jan 04, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 77 (of 346)

CHLORPROMAZINE HYDROCHLORIDE
TABLET; ORAL
CHLORPROMAZINE HYDROCHLORIDE
LEDERLE
25MG
50MG
100MG
200MG
PUREPAC PHARM
10MG
25MG
50MG
100MG
200MG
PVT FORM
25MG
50MG
200MG
ROXANE
10MG
25MG
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

A084801
A084800
A084789
A084802
A080403
A080403
A080403
A080403
A080403
A080340
A080340
A080340
A085331
A085331
A085331
A085331
A085331
A088038
A087645
A087646
A085959
A085956
A085960
A085957
A085958
A087783
A087865
A087878
A087884
A087880

001
001
001
001
004
001
002
003
005
001
002
003
001
002
003
004
005
001
001
001
001
001
001
001
001
001
001
001
001
001

A086886
A084423
A086887
A086888
A086885

001
001
001
001
001

N009149
N009149
N009149
N009149
N009149

002
007
013
018
020

A088812
A089446
A088813
A089447
A089561
A089562
A088918
A088919
A089321
A088662
A088840
A087353
A088175
A088176

001
001
001
001
001
001
001
001
001
001
001
001
001
001

Aug 16, 1982

Sep
Sep
Sep
Sep
Sep

16,
16,
15,
15,
16,

1982
1982
1982
1982
1982

Oct
Nov
Oct
Nov
Sep
Sep
Oct
Oct
Jan
Jan
Oct

19,
17,
19,
17,
04,
04,
16,
16,
16,
09,
25,

1984
1986
1984
1986
1987
1987
1984
1984
1986
1986
1984

CHLORPROPAMIDE
TABLET; ORAL
CHLORPROPAMIDE
BARR

CLONMEL HLTHCARE
DURAMED PHARMS BARR
HALSEY
IVAX PHARMS
PAR PHARM

100MG
100MG
250MG
250MG
100MG
250MG
100MG
250MG
100MG
250MG
100MG
250MG
100MG
250MG

Feb 27, 1984

Feb 27, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 78 (of 346)

CHLORPROPAMIDE
TABLET; ORAL
CHLORPROPAMIDE
SANDOZ

SUPERPHARM
TEVA
USL PHARMA
WATSON LABS

GLUCAMIDE
TEVA

100MG
250MG
250MG
100MG
250MG
100MG
100MG
250MG
100MG
100MG
250MG
250MG

A088725
A084669
A088726
A088694
A088695
A088768
A088708
A088709
A086865
A088608
A086866
A088568

001
001
001
001
001
001
001
001
001
001
001
001

Aug 31, 1984

Aug
Sep
Sep
Oct
Aug
Aug
Sep
Apr

250MG

A088641

001

Oct 11, 1984

100MG/5ML

N016149

002

12.5MG/ML

N012487

001

10MG
25MG
50MG
100MG

N012486
N012486
N012486
N012486

005
004
003
001

1%

N050404

001

25MG
50MG
25MG
50MG
25MG
50MG
25MG
25MG
50MG
50MG
25MG
50MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG
25MG
50MG
25MG
50MG

A087364
A087384
A087698
A087699
A087451
A087450
A087555
A088164
A087176
A087947
A087311
A087312
A087292
A089285
A089738
A087293
A089286
A089739
A089591
A088139
A088140
A087380
A087118

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

31,
17,
17,
11,
30,
30,
24,
12,

1984
1984
1984
1984
1984
1984
1984
1984

Apr 12, 1984

CHLORPROTHIXENE
CONCENTRATE; ORAL
TARACTAN
ROCHE
INJECTABLE; INJECTION
TARACTAN
ROCHE
TABLET; ORAL
TARACTAN
ROCHE

CHLORTETRACYCLINE HYDROCHLORIDE
OINTMENT; OPHTHALMIC
AUREOMYCIN
LEDERLE

CHLORTHALIDONE
TABLET; ORAL
CHLORTHALIDONE
ABBOTT
ASCOT
CLONMEL HLTHCARE
IVAX PHARMS

KV PHARM
MUTUAL PHARM

PIONEER PHARMS
PUREPAC PHARM
SANDOZ

Oct 20, 1982

Oct 20, 1982

Jan 09, 1984

Feb 27, 1984

Jul 21, 1986

Sep 19, 1988
Jul
Sep
Jul
Jul
Aug

21,
19,
21,
16,
11,

1986
1988
1988
1986
1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 79 (of 346)

CHLORTHALIDONE
TABLET; ORAL
CHLORTHALIDONE
SANDOZ
SUPERPHARM
TEVA
USL PHARMA
VANGARD
WARNER CHILCOTT
WATSON LABS

HYGROTON
SANOFI AVENTIS US
THALITONE
MONARCH PHARMS

50MG
25MG
50MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG

A087381
A087473
A087247
A088651
A089051
A089052
A088012
A088073
A087515
A087516
A087050
A087100
A087296
A087706
A087029
A087082
A087521
A087689

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

25MG
50MG

N012283
N012283

004
003

25MG
25MG

A088051
N019574

001
002

Nov 12, 1982

Feb 12, 1992

A071179
A071178
A071142

001
001
001

Dec 16, 1987

Dec 16, 1987
Dec 16, 1987

N017503
N017503
N017503

001
002
003

Apr 10, 1984

25MG;100MG
25MG;200MG

N019451
N019451

001
002

Dec 31, 1987

Dec 31, 1987

25MG;0.125MG

N015103

002

50MG;0.25MG

N015103

001

250MG
500MG
500MG
250MG
500MG
250MG
250MG
500MG

A088928
A040113
A089970
A081298
A081299
A087981
A089592
A089948

001
001
001
001
001
001
001
001

Feb
Feb
May
Jun
Jun
Jul
Mar
Jan
Feb

09,
09,
30,
01,
01,
14,
25,
24,
09,

1983
1983
1985
1987
1987
1982
1983
1983
1983

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

TABLET; ORAL
CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
PAR PHARM
15MG;0.1MG
15MG;0.2MG
15MG;0.3MG
COMBIPRES
BOEHRINGER INGELHEIM 15MG;0.1MG
15MG;0.2MG
15MG;0.3MG

CHLORTHALIDONE; METOPROLOL TARTRATE

CAPSULE; ORAL
LOPRESSIDONE
NOVARTIS

CHLORTHALIDONE; RESERPINE
TABLET; ORAL
DEMI-REGROTON
SANOFI AVENTIS US
REGROTON
SANOFI AVENTIS US

CHLORZOXAZONE
TABLET; ORAL
CHLORZOXAZONE
ACTAVIS TOTOWA
MUTUAL PHARM
OHM LABS
PAR PHARM
PIONEER PHARMS

May
Sep
Sep
Dec
Dec
Sep
Jan
Jan

08,
29,
27,
29,
29,
20,
06,
06,

1987
1995
1990
1993
1993
1983
1989
1989

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DISCONTINUED DRUG PRODUCT LIST

6 - 80 (of 346)

CHLORZOXAZONE
TABLET; ORAL
CHLORZOXAZONE
SANDOZ
WATSON LABS

PARAFLEX
ORTHO MCNEIL PHARM
STRIFON FORTE DSC
FERNDALE LABS

250MG
500MG
250MG
250MG
500MG

A089852
A089853
A086901
A086948
A081019

001
001
001
001
001

May 04, 1988

May 04, 1988

250MG

N011300

003

500MG

A081008

001

Dec 23, 1988

EQ 4GM RESIN/BAR
EQ 4GM RESIN/BAR

A071621
A071739

001
001

May 26, 1988

May 26, 1988

EQ
EQ
EQ
EQ
EQ
EQ

4GM
4GM
4GM
4GM
4GM
4GM

RESIN/PACKET
RESIN/SCOOPFUL
RESIN/PACKET
RESIN/SCOOPFUL
RESIN/PACKET
RESIN/SCOOPFUL

A074771
A074771
A074347
A074347
A074554
A074554

001
002
001
002
001
002

Jul
Jul
May
May
Oct
Oct

09,
09,
28,
28,
02,
02,

1997
1997
1998
1998
1996
1996

EQ
EQ
EQ
EQ

4GM
4GM
4GM
4GM

RESIN/PACKET
RESIN/SCOOPFUL
RESIN/PACKET
RESIN/SCOOPFUL

A074348
A074348
A074555
A074555

001
002
001
002

May
May
Sep
Sep

28,
28,
30,
30,

1998
1998
1998
1998

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

N016640
N016640

001
003

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

N019669
N019669

001
003

Dec 05, 1988

Dec 05, 1988

EQ 800MG RESIN
EQ 1GM RESIN

A073403
A073403

002
001

Dec 27, 1999

Apr 28, 1994

0.25MG/VIAL

N021149

001

Sep 20, 2000

EQ 0.004MG CHROMIUM/ML

N019271

001

May 05, 1987

5mCi/ML

N017084

001

4,000 UNITS/VIAL
10,000 UNITS/VIAL

N018663
N018663

002
001

Aug 09, 1982

Jul 29, 1991

CHOLESTYRAMINE
BAR, CHEWABLE; ORAL
CHOLYBAR
PARKE DAVIS
POWDER; ORAL
CHOLESTYRAMINE
IVAX SUB TEVA PHARMS
TEVA
TEVA PHARMS
CHOLESTYRAMINE LIGHT
TEVA
TEVA PHARMS
QUESTRAN
BRISTOL MYERS
QUESTRAN LIGHT
BRISTOL MYERS
TABLET; ORAL
QUESTRAN
APOTHECON

CHORIOGONADOTROPIN ALFA
INJECTABLE; INJECTION
OVIDREL
EMD SERONO

CHROMIC CHLORIDE
INJECTABLE; INJECTION
CHROMIC CHLORIDE
ABRAXIS PHARM

CHROMIC PHOSPHATE P-32

INJECTABLE; INJECTION
PHOSPHOCOL P32
MALLINCKRODT

CHYMOPAPAIN
INJECTABLE; INJECTION
CHYMODIACTIN
CHART MEDCL

Aug 21, 1984

Nov 10, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 81 (of 346)

CHYMOPAPAIN
INJECTABLE; INJECTION
DISCASE
ABBOTT

12,500 UNITS/VIAL

N018625

001

Jan 18, 1984

750 UNITS/VIAL

N011837

001

300 UNITS/VIAL
150 UNITS/VIAL

N016938
N018121

001
001

750 UNITS/VIAL

N011903

001

EQ 750MG BASE/VIAL;750MG/VIAL

N050630

002

Dec 14, 1990

100MG
100MG
50MG
100MG

A077028
A077020
A077208
A077208

002
002
002
001

Nov
Mar
Mar
Mar

200MG/20ML

N020951

001

Jul 09, 1999

200MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG
100MG
200MG
200MG
300MG
400MG
800MG
100MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG
200MG
300MG
400MG
800MG

A074281
A074281
A074281
A074329
A074401
A074401
A074401
A074402
A075122
A074250
A075122
A074250
A074250
A074250
A074972
A074361
A074361
A074371
A074100
A074100
A074100
A074100
A074365
A074365
A074365
A074365

001
002
003
001
001
002
003
001
001
001
002
002
003
004
001
001
002
001
001
002
003
004
001
002
003
004

May
May
May
May
May
May
May
May
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Dec
Dec
Dec
Jan
Jan
Jan
Jan
Feb
Feb
Feb
Feb

100MG

N020238

001

Jun 19, 1995

CHYMOTRYPSIN
FOR SOLUTION; OPHTHALMIC
ALPHA CHYMAR
SOLA BARNES HIND
CATARASE
CIBA
NOVARTIS
ZOLYSE
ALCON

CILASTATIN SODIUM; IMIPENEM

INJECTABLE; INJECTION
PRIMAXIN
MERCK

CILOSTAZOL
TABLET; ORAL
CILOSTAZOL
ACTAVIS TOTOWA
IVAX SUB TEVA PHARMS
MUTUAL PHARM

26,
01,
29,
29,

2004
2005
2006
2006

CIMETIDINE
SUSPENSION; ORAL
TAGAMET HB 200
GLAXOSMITHKLINE
TABLET; ORAL
CIMETIDINE
ENDO PHARMS

IVAX SUB TEVA PHARMS

LEK PHARMS

PERRIGO
ROXANE

SANDOZ

TEVA

TAGAMET HB
GLAXOSMITHKLINE

17,
17,
17,
17,
30,
30,
30,
30,
19,
29,
19,
29,
29,
29,
19,
23,
23,
23,
31,
31,
31,
31,
28,
28,
28,
28,

1994
1994
1994
1994
1995
1995
1995
1995
1998
1995
1998
1995
1995
1995
1998
1994
1994
1994
1995
1995
1995
1995
1995
1995
1995
1995

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DISCONTINUED DRUG PRODUCT LIST

6 - 82 (of 346)

CIMETIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
CIMETIDINE HYDROCHLORIDE
ENDO PHARMS
EQ 300MG BASE/2ML
A074005
HOSPIRA
EQ 300MG BASE/2ML
A074296
EQ 300MG BASE/2ML
A074412
EQ 300MG BASE/2ML
A074422
LUITPOLD
EQ 300MG BASE/2ML
A074353
TEVA PARENTERAL
EQ 300MG BASE/2ML
A074252
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA
EQ 6MG BASE/ML
A074269
EQ 90MG BASE/100ML
A074468
EQ 120MG BASE/100ML
A074468
EQ 180MG BASE/100ML
A074468
EQ 240MG BASE/100ML
A074468
EQ 360MG BASE/100ML
A074468
EQ 480MG BASE/100ML
A074468
TAGAMET
GLAXOSMITHKLINE
EQ 300MG BASE/2ML
N017939
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
GLAXOSMITHKLINE
EQ 6MG BASE/ML
N019434
SOLUTION; ORAL
CIMETIDINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC EQ 300MG BASE/5ML
A074176
DURAMED PHARMS BARR
EQ 300MG BASE/5ML
A075110
ENDO PHARMS
EQ 300MG BASE/5ML
A074251
ROXANE
EQ 300MG BASE/5ML
A074541
TEVA PHARMS
EQ 300MG BASE/5ML
A074859
TAGAMET
GLAXOSMITHKLINE
EQ 300MG BASE/5ML
N017924

001
001
001
001
001
001

Aug
Mar
Mar
Jan
Dec
Nov

31,
28,
28,
31,
20,
26,

1994
1997
1997
1995
1994
1997

001
005
006
003
004
001
002

Dec
Dec
Dec
Dec
Dec
Dec
Dec

27,
29,
29,
29,
29,
29,
29,

1994
1994
1994
1994
1994
1994
1994

002
001

Oct 31, 1985

001
001
001
001
001

Jun
Jun
Dec
Aug
Jul

01,
18,
22,
05,
09,

1994
1998
1994
1997
1998

001

CINOXACIN
CAPSULE; ORAL
CINOBAC
LILLY
CINOXACIN
TEVA

250MG
500MG

N018067
N018067

001
002

250MG
500MG

A073005
A073006

001
001

Feb 28, 1992

Feb 28, 1992

N019847

003

Dec 26, 1990

N019858

001

Dec 26, 1990

A076484
A076484
A076992
A076992
A076993

001
002
001
002
001

Aug
Aug
Aug
Aug
Aug

A076757

001

Apr 21, 2008

A078114
A078114
A077138
A077138

001
002
001
002

Mar
Mar
Mar
Mar

CIPROFLOXACIN
INJECTABLE; INJECTION
CIPRO
BAYER HLTHCARE
1200MG/120ML (10MG/ML)
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAYER PHARMS
200MG/100ML
CIPROFLOXACIN
APP PHARMS
200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
BEDFORD LABS
200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
1200MG/120ML (10MG/ML)
CIPROFLOXACIN IN DEXTROSE 5%
HIKMA FARMACEUTICA
200MG/100ML
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
BEDFORD
200MG/100ML
400MG/200ML
TEVA PHARMS
200MG/100ML
400MG/200ML

28,
28,
28,
28,
28,

18,
18,
18,
18,

2006
2006
2006
2006
2006

2008
2008
2008
2008

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6 - 83 (of 346)

CIPROFLOXACIN HYDROCHLORIDE
TABLET; ORAL
CIPROFLOXACIN HYDROCHLORIDE
BARR
EQ 250MG
EQ 500MG
EQ 750MG
NOSTRUM LABS
EQ 250MG
EQ 500MG
EQ 750MG
SANDOZ
EQ 100MG
EQ 250MG
EQ 250MG
EQ 500MG
EQ 500MG
EQ 750MG
EQ 750MG
TEVA
EQ 250MG
EQ 500MG
EQ 750MG
TABLET, EXTENDED RELEASE; ORAL
PROQUIN XR
DEPOMED INC
EQ 500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A074124
A074124
A074124
A076138
A076138
A076138
A075939
A075939
A076593
A075939
A076593
A075939
A076593
A076136
A076136
A076136

001
002
003
001
002
003
001
002
002
003
003
004
004
001
002
003

Jun
Jun
Jun
Jun
Jun
Jun
Mar
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

09,
09,
09,
09,
09,
09,
03,
09,
09,
09,
09,
09,
09,
09,
09,
09,

2004
2004
2004
2004
2004
2004
2005
2004
2004
2004
2004
2004
2004
2004
2004
2004

BASE

N021744

001

May 19, 2005

A078712

001

Dec 11, 2007

N020398

001

Sep 15, 1995

N020210
N020210

001
002

Jul 29, 1993

Dec 23, 1993

N020767

001

Nov 07, 1997

10MG/VIAL
50MG/VIAL

A074713
A074713

001
002

Nov 14, 2000

Nov 14, 2000

10MG/VIAL
50MG/VIAL

N018057
N018057

001
002

0.5MG/ML
1MG/ML

N018057
N018057

003
004

Jul 18, 1984

Nov 08, 1988

A077601

001

Nov 15, 2005

N020822

004

Jul 17, 1998

A077033
A077033
A077033
A077052

001
002
003
001

Oct
Oct
Oct
Jul

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL
CIPROFLOXACIN EXTENDED RELEASE
SANDOZ
212.6MG;EQ 287.5MG BASE

CISAPRIDE MONOHYDRATE
SUSPENSION; ORAL
PROPULSID
JANSSEN PHARMS
TABLET; ORAL
PROPULSID
JANSSEN PHARMS

EQ 1MG BASE/ML

EQ 10MG BASE
EQ 20MG BASE
TABLET, ORALLY DISINTEGRATING; ORAL
PROPULSID QUICKSOLV
JANSSEN PHARMA
EQ 20MG BASE

CISPLATIN
INJECTABLE; INJECTION
CISPLATIN
BEDFORD
PLATINOL
CORDEN PHARMA
PLATINOL-AQ
CORDEN PHARMA

CITALOPRAM HYDROBROMIDE
SOLUTION; ORAL
CITALOPRAM HYDROBROMIDE
APOTEX INC
EQ 10MG BASE/5ML
TABLET; ORAL
CELEXA
FOREST LABS
EQ 60MG BASE
CITALOPRAM HYDROBROMIDE
ACTAVIS ELIZABETH
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
MUTUAL PHARM
EQ 10MG BASE

28,
28,
28,
03,

2004
2004
2004
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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6 - 84 (of 346)

CITALOPRAM HYDROBROMIDE
TABLET; ORAL
CITALOPRAM HYDROBROMIDE
MUTUAL PHARM
EQ 20MG BASE
EQ 40MG BASE
ROXANE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
SANDOZ
EQ 10MG BASE
EQ 20MG 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
BIOVAIL LABS INTL
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE

A077052
A077052
A077041
A077041
A077041
A077040
A077040
A077040
A077278
A077278
A077278
A077213
A077213
A077213

002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jul
Jul
Nov
Nov
Nov
Aug
Aug
Aug
Mar
Mar
Mar
Mar
Mar
Mar

03,
03,
23,
23,
23,
17,
17,
17,
22,
22,
22,
31,
31,
31,

2006
2006
2004
2004
2004
2005
2005
2005
2006
2006
2006
2006
2006
2006

N021763
N021763
N021763

001
002
003

Dec 20, 2005

Dec 20, 2005
Dec 20, 2005

N018519

001

Jun 22, 1982

N018904

001

May 27, 1983

N050698

003

Sep 30, 1998

A065137
A065137

001
002

May 31, 2005

May 31, 2005

A065210

001

Jan 26, 2005

EQ 0.5MG BASE/5ML
EQ 0.5MG BASE/5ML

A074075
A073095

001
001

Oct 31, 1993

Apr 21, 1992

EQ 0.5MG BASE/5ML

N018675

001

Jun 28, 1985

1.34MG
1.34MG

A073282
A073282

001
002

Jan 31, 1992

Dec 03, 1992

2.68MG

N017661

001

1.34MG
1.34MG

N017661
N017661

002
003

Aug 21, 1992

N018298
N018298

001
002

Dec 15, 1982

Aug 21, 1992

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
HOSPIRA
3.24GM/100ML;380MG/100ML;430MG/100ML

CLARITHROMYCIN
FOR SUSPENSION; ORAL
BIAXIN
ABBOTT
TABLET; ORAL
CLARITHROMYCIN
IVAX SUB TEVA PHARMS

187MG/5ML

250MG
500MG
TABLET, EXTENDED RELEASE; ORAL
CLARITHROMYCIN
RANBAXY
1GM

CLEMASTINE FUMARATE
SYRUP; ORAL
CLEMASTINE FUMARATE
ACTAVIS MID ATLANTIC
TEVA PHARMS
TAVIST
NOVARTIS
TABLET; ORAL
CLEMASTINE FUMARATE
TEVA
TAVIST
NOVARTIS
TAVIST-1
NOVARTIS

CLEMASTINE FUMARATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL
TAVIST-D
NOVARTIS
EQ 1MG BASE;75MG
1.34MG;75MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 85 (of 346)

CLEMASTINE FUMARATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL
TAVIST-D
NOVARTIS
1.34MG;75MG

N020640

001

Aug 09, 1996

N010355
N010355

001
002

75MG BASE
150MG BASE

A061809
A061809

001
002

75MG BASE
75MG BASE

A063027
A063082

001
001

EQ 75MG BASE/5ML

A061827

001

EQ 2% BASE

N050680

001

EQ 150MG BASE/ML

A061839

001

A062747
A062928
A062806
A062953
A063068
A063163
A062908
A062905
A062913
A062819
A062852
A063041
A063282
A062900
A063079

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Feb
Oct
Apr
Aug
Jun
Feb
May
Oct
Mar
Mar
Dec
May
Jun
Mar

N050636

001

Dec 22, 1989

A065027
A065027
A065027
N050648
N050648
N050648

001
002
003
001
002
003

Jun
Jun
Jun
Dec
Dec
Dec

A062363

001

Feb 08, 1982

A062811
A062930

001
001

Sep 01, 1988

Jun 28, 1989

CLIDINIUM BROMIDE
CAPSULE; ORAL
QUARZAN
ROCHE

2.5MG
5MG

CLINDAMYCIN HYDROCHLORIDE
CAPSULE; ORAL
CLEOCIN
PHARMACIA AND UPJOHN

EQ
EQ
CLINDAMYCIN HYDROCHLORIDE
TEVA
EQ
WATSON LABS
EQ

Sep 20, 1989

Jul 31, 1991

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
BAXTER HLTHCARE

EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
BEDFORD
EQ 150MG BASE/ML
BRISTOL MYERS SQUIBB 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%
ABRAXIS PHARM
EQ 12MG BASE/ML
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 18MG BASE/ML
BAXTER HLTHCARE
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 900MG BASE/100ML
SOLUTION; TOPICAL
CLEOCIN T
PHARMACIA AND UPJOHN EQ 1% BASE
CLINDAMYCIN PHOSPHATE
ACTAVIS MID ATLANTIC EQ 1% BASE
BOCA PHARMA
EQ 1% BASE

Aug 11, 1992

03,
13,
15,
21,
28,
30,
01,
09,
20,
15,
17,
29,
29,
08,
05,

29,
29,
29,
29,
29,
29,

1988
1989
1987
1988
1989
1994
1989
1988
1988
1988
1988
1989
1992
1988
1990

2001
2001
2001
1989
1989
1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 86 (of 346)

CLINDAMYCIN PHOSPHATE
SOLUTION; TOPICAL
CLINDAMYCIN PHOSPHATE
COPLEY PHARM
COREPHARMA

EQ 1% BASE
EQ 1% BASE

A062944
A064108

001
001

Jan 11, 1989

Sep 27, 1996

10MG/GM;100,000 UNITS/GM

N050235

001

A074139
A075338

001
001

Aug 03, 1994

Feb 09, 2001

A075733

001

Aug 22, 2001

A074128
A075057

001
001

Aug 03, 1994

Aug 12, 1998

A074331

001

Dec 15, 1995

100MG

N019500

001

Dec 15, 1986

500MG

N016099

002

500MG
500MG
500MG
500MG
500MG

A073396
A072191
A072600
A070531
A071603

001
001
001
001
001

Mar
May
Jul
Jun
Sep

50MG

A072196

001

Dec 20, 1988

A074953
A074953
A074953
A074849
A074849
A074849
A074600
A074751
A074600
A074751
A074600
A074751

001
002
003
001
002
003
001
001
002
002
003
003

Jun
Jun
Jun
Apr
Apr
Apr
Nov
Sep
Nov
Sep
Nov
Sep

CLIOQUINOL; NYSTATIN
OINTMENT; TOPICAL
NYSTAFORM
BAYER PHARMS

CLOBETASOL PROPIONATE
CREAM; TOPICAL
CLOBETASOL PROPIONATE
ACTAVIS MID ATLANTIC 0.05%
COREPHARMA
0.05%
CLOBETASOL PROPIONATE (EMOLLIENT)
COREPHARMA
0.05%
OINTMENT; TOPICAL
CLOBETASOL PROPIONATE
ACTAVIS MID ATLANTIC 0.05%
COREPHARMA
0.05%
SOLUTION; TOPICAL
CLOBETASOL PROPIONATE
ACTAVIS MID ATLANTIC 0.05%

CLOFAZIMINE
CAPSULE; ORAL
LAMPRENE
NOVARTIS

CLOFIBRATE
CAPSULE; ORAL
ATROMID-S
WYETH AYERST
CLOFIBRATE
BANNER PHARMACAPS
SANDOZ
TEVA
USL PHARMA
WATSON LABS

20,
02,
25,
16,
18,

1992
1988
1991
1986
1987

CLOMIPHENE CITRATE
TABLET; ORAL
MILOPHENE
MILEX

CLOMIPRAMINE HYDROCHLORIDE
CAPSULE; ORAL
CLOMIPRAMINE HYDROCHLORIDE
SANDOZ
25MG
50MG
75MG
TEVA
25MG
50MG
75MG
WATSON LABS
25MG
25MG
50MG
50MG
75MG
75MG

25,
25,
25,
04,
04,
04,
27,
30,
27,
30,
27,
30,

1997
1997
1997
1997
1997
1997
1996
1998
1996
1998
1996
1998

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 87 (of 346)

CLONAZEPAM
TABLET; ORAL
CLONAZEPAM
SANDOZ

TEVA

0.5MG
1MG
2MG
0.5MG
1MG
2MG

KLONOPIN
ROCHE

0.125MG
0.25MG
TABLET, ORALLY DISINTEGRATING; ORAL
KLONOPIN RAPIDLY DISINTEGRATING
ROCHE
0.125MG
0.25MG
0.5MG
1MG
2MG

A074925
A074925
A074925
A074920
A074920
A074920

001
002
003
001
002
003

Sep
Sep
Sep
Aug
Aug
Aug

30,
30,
30,
04,
04,
04,

N017533
N017533

005
006

Apr 09, 1997

Apr 09, 1997

N020813
N020813
N020813
N020813
N020813

001
002
003
004
005

Dec
Dec
Dec
Dec
Dec

N022499

001

Dec 03, 2009

N022500
N022500

001
002

Dec 03, 2009

Dec 03, 2009

A070881
A070882
A070883
A071103
A071102
A071101
A071252
A071253
A071254
A070461
A070460
A070459
A070887
A070886
A071294
A070747
A070702
A070659
A072138
A072139
A072140
A070395
A070965
A070396
A070964
A070397

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jul
Jul
Jul
Aug
Aug
Aug
Oct
Oct
Oct
Jul
Jul
Jul
Aug
Aug
Aug
Jul
Jul
Jul
Jun
Jun
Jun
Mar
Jul
Mar
Jul
Mar

N022331
N022331

001
002

Sep 30, 2009

May 25, 2010

N022331

004

Sep 28, 2010

23,
23,
23,
23,
23,

1997
1997
1997
1998
1998
1998

1997
1997
1997
1997
1997

CLONIDINE
SUSPENSION, EXTENDED RELEASE; ORAL
CLONIDINE
TRIS PHARMA INC
EQ 0.09MG BASE/ML
TABLET, EXTENDED RELEASE; ORAL
CLONIDINE
TRIS PHARMA INC
EQ 0.17MG BASE
EQ 0.26MG BASE

CLONIDINE HYDROCHLORIDE
TABLET; ORAL
CLONIDINE HYDROCHLORIDE
AM THERAP
0.1MG
0.2MG
0.3MG
DURAMED PHARMS BARR
0.1MG
0.2MG
0.3MG
INTERPHARM
0.1MG
0.2MG
0.3MG
PAR PHARM
0.1MG
0.2MG
0.3MG
SANDOZ
0.1MG
0.2MG
0.3MG
TEVA
0.1MG
0.2MG
0.3MG
WARNER CHILCOTT
0.1MG
0.2MG
0.3MG
WATSON LABS
0.1MG
0.1MG
0.2MG
0.2MG
0.3MG
TABLET, EXTENDED RELEASE; ORAL
JENLOGA
SHIONOGI INC
0.1MG
0.2MG
KAPVAY
SHIONOGI INC
0.2MG

08,
08,
08,
14,
14,
14,
01,
01,
01,
08,
08,
08,
31,
31,
31,
08,
08,
08,
13,
13,
13,
23,
08,
23,
08,
23,

1986
1986
1986
1986
1986
1986
1986
1986
1986
1986
1986
1986
1988
1988
1988
1986
1986
1986
1988
1988
1988
1987
1986
1987
1986
1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 88 (of 346)

CLOPIDOGREL BISULFATE
TABLET; ORAL
CLOPIDOGREL BISULFATE
DR REDDYS LABS INC

EQ 75MG BASE

A076273

001

Jan 14, 2008

A071777
A071778
A071779
A071429
A071430
A071431
A071742
A071743
A071744
A071727
A071728
A071729
A071509
A071510
A071511
A071924
A071925
A071926
A071549
A071550
A071522
A072219
A072220
A072112
A071242
A071243
A071244
A071774
A071775
A071776
A071878
A071879
A071860

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jul
Jul
Jul
Jun
Jun
Jun
Dec
Dec
Dec
Dec
Dec
Dec
Oct
Oct
Oct
Apr
Apr
Apr
Sep
Sep
Sep
Aug
Aug
Aug
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Mar
Mar

14,
14,
14,
23,
23,
23,
14,
14,
14,
18,
18,
18,
19,
19,
19,
25,
25,
25,
12,
12,
12,
26,
26,
26,
23,
23,
23,
01,
01,
01,
15,
15,
15,

1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1988
1988
1988
1988
1988
1988
1988
1988
1988
1987
1987
1987
1988
1988
1988
1988
1988
1988

N017105
N017105
N017105

001
002
003

A071780
A071781
A071782
A071747
A071748
A071749
A072013
A072014
A072015
A072330
A072331
A072332
A071730
A071731
A071702
A072512

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jun
Jun
Jun
Jun
Jun
Dec
Dec
Dec
Aug
Aug
Aug
Oct
Oct
Oct
May

26,
26,
26,
23,
23,
23,
15,
15,
15,
08,
08,
08,
26,
26,
26,
11,

1987
1987
1987
1987
1987
1987
1987
1987
1987
1988
1988
1988
1987
1987
1987
1990

CLORAZEPATE DIPOTASSIUM
CAPSULE; ORAL
CLORAZEPATE DIPOTASSIUM
ABLE
3.75MG
7.5MG
15MG
AM THERAP
3.75MG
7.5MG
15MG
CLONMEL HLTHCARE
3.75MG
7.5MG
15MG
GD SEARLE LLC
3.75MG
7.5MG
15MG
MYLAN
3.75MG
7.5MG
15MG
PUREPAC PHARM
3.75MG
7.5MG
15MG
QUANTUM PHARMICS
3.75MG
7.5MG
15MG
SANDOZ
3.75MG
7.5MG
15MG
USL PHARMA
3.75MG
7.5MG
15MG
WARNER CHILCOTT
3.75MG
7.5MG
15MG
WATSON LABS
3.75MG
7.5MG
15MG
TRANXENE
LUNDBECK INC
3.75MG
7.5MG
15MG
TABLET; ORAL
CLORAZEPATE DIPOTASSIUM
ABLE
3.75MG
7.5MG
15MG
AM THERAP
3.75MG
7.5MG
15MG
LEDERLE
3.75MG
7.5MG
15MG
PUREPAC PHARM
3.75MG
7.5MG
15MG
QUANTUM PHARMICS
3.75MG
7.5MG
15MG
SANDOZ
3.75MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 89 (of 346)

CLORAZEPATE DIPOTASSIUM
TABLET; ORAL
CLORAZEPATE DIPOTASSIUM
SANDOZ
7.5MG
15MG
WARNER CHILCOTT
3.75MG
7.5MG
15MG
TRANXENE SD
LUNDBECK INC
11.25MG
22.5MG

A072513
A072514
A071828
A071829
A071830

001
001
001
001
001

May
May
Mar
Mar
Mar

11,
11,
03,
03,
03,

1990
1990
1988
1988
1988

N017105
N017105

005
004

1%

N017619

001

1%

N018183

001

1%

N018813

001

1%

N017613

001

100MG

A073249

001

Feb 13, 1998

500MG

N019069

001

Apr 19, 1985

CLOTRIMAZOLE
CREAM; TOPICAL
LOTRIMIN
SCHERING PLOUGH
MYCELEX
BAYER PHARMS
LOTION; TOPICAL
LOTRIMIN
SCHERING
SOLUTION; TOPICAL
LOTRIMIN
SCHERING PLOUGH
TABLET; VAGINAL
GYNIX
TEVA PHARMS
MYCELEX-G
BAYER PHARMS

Feb 17, 1984

CLOXACILLIN SODIUM
CAPSULE; ORAL
CLOXACILLIN SODIUM
APOTHECON
TEVA
CLOXAPEN
GLAXOSMITHKLINE

FOR SOLUTION; ORAL

CLOXACILLIN SODIUM
TEVA
TEGOPEN
APOTHECON

EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE

A061452
A061452
A062240
A062240

001
002
001
002

EQ
EQ
EQ
EQ

250MG
250MG
500MG
500MG

BASE
BASE
BASE
BASE

A061806
A062233
A061806
A062233

001
001
002
002

EQ 125MG BASE/5ML
EQ 125MG BASE/5ML

A062268
A062978

001
001

EQ 125MG BASE/5ML
EQ 125MG BASE/5ML

A061453
N050192

001
001

A075162
A075162
A074546
A074546

001
002
001
002

Apr
Apr
Aug
Aug

N021590

003

Jun 03, 2005

Apr 06, 1989

CLOZAPINE
TABLET; ORAL
CLOZAPINE
PAR PHARM

25MG
100MG
SANDOZ
25MG
100MG
TABLET, ORALLY DISINTEGRATING; ORAL
FAZACLO ODT
AZUR PHARMA INTL
50MG

26,
26,
30,
30,

2005
2005
1996
1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 90 (of 346)

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
PHERAZINE VC W/ CODEINE
HALSEY
10MG/5ML;5MG/5ML;6.25MG/5ML
PROMETHAZINE VC W/ CODEINE
CENCI
10MG/5ML;5MG/5ML;6.25MG/5ML
WOCKHARDT
10MG/5ML;5MG/5ML;6.25MG/5ML

N008306

005

Apr 02, 1984

A088870

001

Mar 02, 1987

A088816
A088896

001
001

Nov 22, 1985

Jan 04, 1985

N008306

004

Apr 02, 1984

A088739

001

Dec 23, 1988

A088814

001

Nov 22, 1985

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL
PHENERGAN W/ CODEINE
ANI PHARMS
10MG/5ML;6.25MG/5ML
PHERAZINE W/ CODEINE
HALSEY
10MG/5ML;6.25MG/5ML
PROMETHAZINE W/ CODEINE
CENCI
10MG/5ML;6.25MG/5ML

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

SYRUP; ORAL
ACTIFED W/ CODEINE
GLAXOSMITHKLINE
10MG/5ML;30MG/5ML;1.25MG/5ML
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE
CENCI
10MG/5ML;30MG/5ML;1.25MG/5ML
TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL AND CODEINE PHOSPHATE
WOCKHARDT
10MG/5ML;30MG/5ML;1.25MG/5ML

N012575

003

Apr 04, 1984

A089018

001

Jul 23, 1986

A088833

001

Nov 16, 1984

N012383

001

A085552

001

A084321
A083720
A083734
A086130

001
002
001
001

A086954
A083221

001
001

375MG

N021141

001

EQ 25MG BASE/5ML

N050355

001

COLCHICINE; PROBENECID
TABLET; ORAL
COLBENEMID
MERCK
0.5MG;500MG
PROBEN-C
WATSON LABS
0.5MG;500MG
PROBENECID AND COLCHICINE
BEECHAM
0.5MG;500MG
IMPAX LABS
0.5MG;500MG
IVAX SUB TEVA PHARMS 0.5MG;500MG
SANDOZ
0.5MG;500MG
PROBENECID W/ COLCHICINE
LEDERLE
0.5MG;500MG
WATSON LABS
0.5MG;500MG

COLESEVELAM HYDROCHLORIDE
CAPSULE; ORAL
WELCHOL
DAIICHI SANKYO

COLISTIN SULFATE
SUSPENSION; ORAL
COLY-MYCIN S
PARKE DAVIS

May 26, 2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 91 (of 346)

CONIVAPTAN HYDROCHLORIDE
INJECTABLE; IV (INFUSION)
VAPRISOL
ASTELLAS
20MG/4ML (5MG/ML)

N021697

001

N017408

001

N018205

001

25 UNITS/VIAL
40 UNITS/VIAL

N008317
N008317

002
004

25 UNITS/VIAL
40 UNITS/VIAL

N007504
N007504

002
003

40 UNITS/ML
80 UNITS/ML
40 UNITS/VIAL

N010831
N010831
A088772

001
002
001

N008372

006

N008975
N008975

001

002

40 UNITS/ML

N009854

001

25MG/ML
25MG/ML
25MG/ML
50MG/ML
50MG/ML

N008126
A083147
A085677
A083147
A085677

002
003
001
004
002

25MG/ML
50MG/ML

N007110
N007110

002
003

25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
5MG
25MG
5MG
10MG
25MG
25MG

A083471
A080836
A084246
A085736
N009458
A080731
A080630
A083536
A080694
N008284
N008284
N008126
N008126
N008126
A080493

001
001
001
001
001
001
001
001
001
002
001
003
004
001
001

Dec 29, 2005

COPPER
INTRAUTERINE DEVICE; INTRAUTERINE
CU-7
GD SEARLE LLC
89MG
TATUM-T
GD SEARLE LLC
120MG

CORTICOTROPIN
INJECTABLE; INJECTION
ACTH
PARKEDALE
ACTHAR
SANOFI AVENTIS US
CORTICOTROPIN
ORGANICS LAGRANGE

WATSON LABS
H.P. ACTHAR GEL

QUESTCOR PHARMS
40 UNITS/ML
PURIFIED CORTROPHIN GEL

ORGANON USA INC

40 UNITS/ML
80 UNITS/ML

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

Nov 21, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 92 (of 346)

CORTISONE ACETATE
TABLET; ORAL
CORTISONE ACETATE
VITARINE
WATSON LABS
WHITEWORTH TOWN PLSN
CORTONE
MERCK

25MG
25MG
25MG

A080333
A085884
A080341

001
001
001

25MG

N007750

003

N016990

001

N019188

001

Dec 22, 1989

A090954

001

Dec 18, 2009

A075067
A075437
A075175

001
001
001

Jul 19, 1999

Apr 21, 2000
Sep 30, 1999

N018596

001

May 28, 1982

A075088

001

Apr 27, 1999

A074800

001

Jul 26, 2001

N020463

001

Jan 03, 1997

260CSR UNIT/ML

N008814

001

260CSR UNIT

N009217

001

EQ 0.4MG COPPER/ML

N019350

001

May 05, 1987

0.5MG/INH

N019722

001

Nov 05, 1996

1MG/ML

N006798

001

0.1MG/ML
1MG/ML

A080855
A080855

001
002

0.1MG/ML
1MG/ML

A083013
A083064

001
001

CROMOLYN SODIUM
CAPSULE; INHALATION
INTAL
SANOFI AVENTIS US
20MG
CAPSULE; ORAL
GASTROCROM
UCB INC
100MG
CONCENTRATE; ORAL
CROMOLYN SODIUM
GENERA PHARMS
100MG/5ML
SOLUTION; INHALATION
CROMOLYN SODIUM
ACTAVIS MID ATLANTIC 10MG/ML
PHARMASCIENCE INC
10MG/ML
ROXANE
10MG/ML
INTAL
KING PHARMS
10MG/ML
SOLUTION/DROPS; OPHTHALMIC
CROMOPTIC
KING PHARMS
4%
SPRAY, METERED; NASAL
CROMOLYN SODIUM
ACTAVIS MID ATLANTIC 5.2MG/SPRAY
NASALCROM
BLACKSMITH BRANDS
5.2MG/SPRAY

CRYPTENAMINE ACETATES
INJECTABLE; INJECTION
UNITENSEN
MEDPOINTE PHARM HLC

CRYPTENAMINE TANNATES
TABLET; ORAL
UNITENSEN
MEDPOINTE PHARM HLC

CUPRIC SULFATE
INJECTABLE; INJECTION
CUPRIC SULFATE
ABRAXIS PHARM

CYANOCOBALAMIN
GEL, METERED; NASAL
NASCOBAL
PAR PHARM
INJECTABLE; INJECTION
BERUBIGEN
PHARMACIA AND UPJOHN
BETALIN 12
LILLY
COBAVITE
WATSON LABS

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DISCONTINUED DRUG PRODUCT LIST

6 - 93 (of 346)

CYANOCOBALAMIN
INJECTABLE; INJECTION
CYANOCOBALAMIN
ABRAXIS PHARM

AKORN
APP PHARMS
BAXTER HLTHCARE
BIONICHE PHARMA
DELL LABS

LUITPOLD
LYPHOMED
SANOFI AVENTIS US
SOLOPAK
WARNER CHILCOTT
WATSON LABS

WYETH AYERST
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

0.03MG/ML
0.1MG/ML
1MG/ML
1MG/ML
0.1MG/ML
1MG/ML
1MG/ML
0.03MG/ML
0.1MG/ML
1MG/ML
0.03MG/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
A080510
A080510
A087969
A080557
A080515
A040451
A080689
A080689
A080689
A080668
A083075
A080564
A087551
N007085
A080573
A083120
A080573
A083120
A080554
A080554

003
001
002
001
002
002
001
001
002
003
001
001
001
001
002
002
001
001
002
001
002

1MG/ML

N006668

010

0.03MG/ML
0.05MG/ML
0.1MG/ML
0.12MG/ML
1MG/ML

N010791
N010791
N010791
N010791
N010791

004
001
002
005
003

0.1MG/ML
1MG/ML
1MG/ML

N006799
N006799
N006799

002
004
010

1MG/ML

A080570

002

1MG/ML

N007012

002

25MCG/SPRAY

N022102

001

1MG

A084264

001

0.5-1uCi

N016089

002

0.5-1uCi

N016090

002

N017406

001

CYANOCOBALAMIN CO-57
CAPSULE; ORAL
RUBRATOPE-57
BRACCO

CYANOCOBALAMIN CO-60
CAPSULE; ORAL
RUBRATOPE-60
BRACCO

CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58

N/A; N/A
DICOPAC KIT
GE HEALTHCARE

N/A;N/A;N/A

Nov 10, 1983

Sep 23, 2003

Feb 29, 1984

Apr 28, 1988

Jul 27, 2007

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DISCONTINUED DRUG PRODUCT LIST

6 - 94 (of 346)

CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR

N/A; N/A
CYANOCOBALAMIN CO 57 SCHILLING TEST KIT
MALLINCKRODT
0.1MG;0.5uCi;60MG

N016635

001

0.5MG/ML;2.3MG/ML;1MG/ML

N011208

001

125MG/5ML
250MG/5ML
500MG/5ML

N050508
N050508
N050508

001
002
003

250MG
500MG

A062895
A062895

001
002

250MG
500MG

N050509
N050509

001
002

50MG/ML

N009495

001

A073683
A073143
A074436

001
001
001

A085555

001

A089162
A084150
A084863

001
001
001

Jan 24, 1991

A088643
A088150

001
001

Feb 09, 1987

Feb 25, 1983

100MG/VIAL
200MG/VIAL
500MG/VIAL
1GM/VIAL

A088371
A088372
A088373
A088374

001
001
001
001

Jul
Jul
Jul
Sep

03,
03,
03,
24,

1986
1986
1986
1986

100MG/VIAL
200MG/VIAL

N012142
N012142

001
002

100MG/VIAL
200MG/VIAL
500MG/VIAL
1GM/VIAL

N012142
N012142
N012142
N012142

006
007
008
010

Dec
Dec
Jan
Sep

05,
10,
04,
24,

1985
1985
1984
1985

CYANOCOBALAMIN; TANNIC ACID; ZINC ACETATE

INJECTABLE; INJECTION
DEPINAR
ARMOUR PHARM

CYCLACILLIN
FOR SUSPENSION; ORAL
CYCLAPEN-W
WYETH AYERST

TABLET; ORAL
CYCLACILLIN
TEVA
CYCLAPEN-W
WYETH AYERST

Aug 04, 1988

Aug 04, 1988

CYCLIZINE LACTATE
INJECTABLE; INJECTION
MAREZINE
GLAXOSMITHKLINE

CYCLOBENZAPRINE HYDROCHLORIDE
TABLET; ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
SANDOZ
10MG
WATSON LABS
10MG
10MG

Feb 26, 1993

Nov 27, 1991
Nov 30, 1994

CYCLOPENTOLATE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
AK-PENTOLATE
AKORN
1%
CYCLOPENTOLATE HYDROCHLORIDE
ALCON UNIVERSAL
1%
SOLA BARNES HIND
1%
1%
PENTOLAIR
PHARMAFAIR
0.5%
1%

CYCLOPHOSPHAMIDE
INJECTABLE; INJECTION
CYCLOPHOSPHAMIDE
BAXTER HLTHCARE

CYTOXAN
BAXTER HLTHCARE
LYOPHILIZED CYTOXAN
BAXTER HLTHCARE

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DISCONTINUED DRUG PRODUCT LIST

6 - 95 (of 346)

CYCLOPHOSPHAMIDE
INJECTABLE; INJECTION
LYOPHILIZED CYTOXAN
BAXTER HLTHCARE
NEOSAR
TEVA PARENTERAL

TABLET; ORAL
CYTOXAN
BAXTER HLTHCARE

2GM/VIAL

N012142

009

Dec 10, 1985

100MG/VIAL
100MG/VIAL
200MG/VIAL
200MG/VIAL
500MG/VIAL
500MG/VIAL
1GM/VIAL
1GM/VIAL
2GM/VIAL
2GM/VIAL

A040015
A087442
A040015
A087442
A040015
A087442
A040015
A087442
A040015
A087442

001
001
002
002
003
003
004
004
005
005

Apr
Feb
Apr
Feb
Apr
Feb
Apr
Jul
Apr
Mar

25MG
50MG

N012141
N012141

002
001

50MG

N050715

003

2MG

N013157

002

2MG

N018173

001

1.25MG
2.5MG

N008951
N008951

001
002

A086833
A089199
A087001
A089021

001
001
001
001

N013220

002

A088798
A087685
A088232
A089057
A086737
A087566
A086678
A087839
A088205
A086808
A087405
A088212
A087284
A085245

001
001
001
001
001
001
001
001
001
001
001
001
001
001

29,
16,
29,
16,
29,
16,
29,
08,
29,
30,

1993
1982
1993
1982
1993
1982
1993
1983
1993
1989

CYCLOSPORINE
CAPSULE; ORAL
NEORAL
NOVARTIS

Jul 14, 1995

CYCLOTHIAZIDE
TABLET; ORAL
ANHYDRON
LILLY
FLUIDIL
PHARMACIA AND UPJOHN

CYCRIMINE HYDROCHLORIDE
TABLET; ORAL
PAGITANE
LILLY

CYPROHEPTADINE HYDROCHLORIDE
SYRUP; ORAL
CYPROHEPTADINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 2MG/5ML
HALSEY
2MG/5ML
MORTON GROVE
2MG/5ML
NASKA
2MG/5ML
PERIACTIN
MERCK
2MG/5ML
TABLET; ORAL
CYPROHEPTADINE HYDROCHLORIDE
AM THERAP
4MG
ASCOT
4MG
DURAMED PHARMS BARR
4MG
HALSEY
4MG
KV PHARM
4MG
MD PHARM
4MG
MYLAN
4MG
PIONEER PHARMS
4MG
PLIVA
4MG
SANDOZ
4MG
SUPERPHARM
4MG
TG UNITED LABS
4MG
VITARINE
4MG
WATSON LABS
4MG

Jul 03, 1986

Nov 04, 1982
Dec 21, 1987

Feb
Oct
Oct
Jul

15,
25,
25,
03,

1985
1982
1983
1986

Nov 10, 1982

Feb 08, 1984
Jul 26, 1983

May 26, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 96 (of 346)

CYPROHEPTADINE HYDROCHLORIDE
TABLET; ORAL
CYPROHEPTADINE HYDROCHLORIDE
WATSON LABS
4MG
4MG
PERIACTIN
MERCK
4MG

A086165
A086580

001
001

N012649

001

7.25%

N019523

001

Oct 22, 1986

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

N016793
N016793
N016793
N016793

001
002
003
004

Dec 21, 1987

Dec 21, 1987

100MG/VIAL
200MG/VIAL

A070962
A070990

001
001

Aug 28, 1986

Aug 28, 1986

N050748

002

Aug 24, 2000

7,500 IU/0.75ML

N020287

008

Apr 04, 2002

750 UNITS/0.6ML

N020430

001

Dec 24, 1996

200MG

A071569

001

Dec 30, 1987

50MG
100MG
200MG

N017557
N017557
N017557

003
004
002

25MG
50MG
100MG

A076686
A076686
A076686

001
002
003

Oct 24, 2005

Oct 24, 2005
Oct 24, 2005

N019849

001

Dec 31, 1990

CYSTEINE HYDROCHLORIDE
INJECTABLE; INJECTION
CYSTEINE HYDROCHLORIDE
HOSPIRA

CYTARABINE
INJECTABLE; INJECTION
CYTARABINE
TEVA PARENTERAL

DACARBAZINE
INJECTABLE; INJECTION
DACARBAZINE
ABRAXIS PHARM

DALFOPRISTIN; QUINUPRISTIN
INJECTABLE; IV (INFUSION)
SYNERCID
KING PHARMS
420MG/VIAL;180MG/VIAL

DALTEPARIN SODIUM
INJECTABLE; INJECTION
FRAGMIN
EISAI INC

DANAPAROID SODIUM
INJECTABLE; INJECTION
ORGARAN
ORGANON USA INC

DANAZOL
CAPSULE; ORAL
DANAZOL
AM THERAP
DANOCRINE
SANOFI AVENTIS US

DANTROLENE SODIUM
CAPSULE; ORAL
DANTROLENE SODIUM
ACTAVIS TOTOWA

DAPIPRAZOLE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
REV-EYES
FERA PHARMS
0.5%

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6 - 97 (of 346)

DAPTOMYCIN
INJECTABLE; IV (INFUSION)
CUBICIN
CUBIST
250MG/VIAL

N021572

001

Sep 12, 2003

N021976

001

Jun 23, 2006

20MG BASE/VIAL
20MG BASE/VIAL

A061876
N050484

001
001

20MG BASE/VIAL
50MG BASE/VIAL

A064212
A064212

001
002

1MG/ML

N006931

002

SOLUTION/DROPS; OPHTHALMIC
HUMORSOL
MERCK
0.125%
0.25%

N011860
N011860

002
001

150MG

N050262

001

75MG/5ML

N050257

001

75MG

N050261

001

0.1MG
0.25MG

N010796
N010796

001
002

0.125MG;25MG

N012148

001

0.125MG;50MG

N012148

003

0.25MG;25MG

N012148

002

0.25MG;5MG

N012775

001

0.5MG;5MG

N012775

002

DARUNAVIR ETHANOLATE
TABLET; ORAL
PREZISTA
TIBOTEC

EQ 300MG BASE

DAUNORUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
CERUBIDINE
SANOFI AVENTIS US
EQ
WYETH AYERST
EQ
DAUNORUBICIN HYDROCHLORIDE
TEVA PARENTERAL
EQ
EQ

DECAMETHONIUM BROMIDE
INJECTABLE; INJECTION
SYNCURINE
GLAXOSMITHKLINE

DEMECARIUM BROMIDE

DEMECLOCYCLINE HYDROCHLORIDE
CAPSULE; ORAL
DECLOMYCIN
LEDERLE
SYRUP; ORAL
DECLOMYCIN
LEDERLE
TABLET; ORAL
DECLOMYCIN
COREPHARMA

DESERPIDINE
TABLET; ORAL
HARMONYL
ABBOTT

DESERPIDINE; HYDROCHLOROTHIAZIDE
TABLET; ORAL
ORETICYL 25
ABBOTT
ORETICYL 50
ABBOTT
ORETICYL FORTE
ABBOTT

DESERPIDINE; METHYCLOTHIAZIDE
TABLET; ORAL
ENDURONYL
ABBOTT
ENDURONYL FORTE
ABBOTT

Jun 23, 1998

May 03, 1999

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6 - 98 (of 346)

DESERPIDINE; METHYCLOTHIAZIDE
TABLET; ORAL
METHYCLOTHIAZIDE AND DESERPIDINE
WATSON LABS
0.25MG;5MG
0.5MG;5MG

A088486
A088452

001
001

Aug 10, 1984

Aug 10, 1984

N013621
N013621

001
002

A071800
A071801
A071802
A071803
A071804
A071864
A071865
A071866
A071867

001
001
001
001
001
001
001
001
001

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

0.15MG;0.03MG
ESTRADIOL
0.15MG;0.03MG

N020071

001

Dec 10, 1992

A075256

001

Aug 12, 1999

0.15MG;0.03MG

N020301

001

Dec 14, 1992

0.05%

A074027

001

Sep 28, 1992

0.25%

A073440

001

Apr 01, 1998

DESIPRAMINE HYDROCHLORIDE
CAPSULE; ORAL
PERTOFRANE
SANOFI AVENTIS US

25MG
50MG

TABLET; ORAL
DESIPRAMINE HYDROCHLORIDE
PLIVA
25MG
50MG
75MG
100MG
150MG
USL PHARMA
25MG
50MG
75MG
100MG

Dec
Dec
Dec
May
May
Sep
Sep
Sep
Sep

08,
08,
08,
29,
29,
09,
09,
09,
09,

1987
1987
1987
1997
1997
1987
1987
1987
1987

DESLANOSIDE
INJECTABLE; INJECTION
CEDILANID-D
NOVARTIS

0.2MG/ML

DESMOPRESSIN ACETATE
INJECTABLE; INJECTION
DDAVP
SANOFI AVENTIS US
0.015MG/ML
DESMOPRESSIN ACETATE
BEDFORD
0.004MG/ML
DESMOPRESSIN ACETATE PRESERVATIVE FREE
BEDFORD
0.004MG/ML
SOLUTION; NASAL
CONCENTRAID
FERRING
0.01%
SPRAY, METERED; NASAL
DDAVP
SANOFI AVENTIS US
0.01MG/SPRAY
STIMATE
CSL BEHRING
0.15MG/SPRAY

DESOGESTREL; ETHINYL ESTRADIOL

TABLET; ORAL-21
DESOGEN
ORGANON USA INC
DESOGESTREL AND ETHINYL
DURAMED PHARMS BARR
ORTHO-CEPT
JANSSEN PHARMS

DESONIDE
CREAM; TOPICAL
DESONIDE
TEVA PHARMS

DESOXIMETASONE
OINTMENT; TOPICAL
DESOXIMETASONE
ALTANA

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6 - 99 (of 346)

DESOXYCORTICOSTERONE ACETATE
INJECTABLE; INJECTION
DOCA
ORGANON USA INC
PELLET; IMPLANTATION
PERCORTEN
NOVARTIS

5MG/ML

N001104

001

125MG

N005151

001

N008822

001

A083296

002

N012731

002

N012376

002

A088997

001

N012674

001

N013538

001

A089170

001

May 09, 1989

N011664
N011664
N011664
N011664
N011664
N011664

004
001
002
003
005
006

Jul 30, 1982

A085376
A084013
A084764
A084084
A084766
A084081
A084765
A084086
A084763
A088149
A083806
A083420
A084614
A080399
A087534
A087533
A085455
A085458
A080968
A084457
A085818
A085456
A085840

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

DESOXYCORTICOSTERONE PIVALATE
INJECTABLE; INJECTION
PERCORTEN
NOVARTIS

25MG/ML

DEXAMETHASONE
AEROSOL; TOPICAL
AEROSEB-DEX
ALLERGAN HERBERT
0.01%
DECASPRAY
MERCK
0.04%
ELIXIR; ORAL
DECADRON
MERCK
0.5MG/5ML
DEXAMETHASONE
ALPHARMA US PHARMS
0.5MG/5ML
HEXADROL
ORGANON USA INC
0.5MG/5ML
GEL; TOPICAL
DECADERM
MERCK
0.1%
SUSPENSION/DROPS; OPHTHALMIC
DEXAMETHASONE
WATSON LABS
0.1%
TABLET; ORAL
DECADRON
MERCK
0.25MG
0.5MG
0.75MG
1.5MG
4MG
6MG
DEXAMETHASONE
IMPAX LABS
0.75MG
MUTUAL PHARM
0.25MG
0.25MG
0.5MG
0.5MG
0.75MG
0.75MG
1.5MG
1.5MG
PAR PHARM
0.25MG
PHOENIX LABS NY
0.75MG
PVT FORM
0.75MG
ROXANE
0.25MG
SANDOZ
0.75MG
UPSHER SMITH
0.75MG
1.5MG
WATSON LABS
0.25MG
0.5MG
0.75MG
0.75MG
0.75MG
1.5MG
1.5MG

Oct 10, 1986

Apr 28, 1983

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DISCONTINUED DRUG PRODUCT LIST

6 - 100 (of 346)

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

0.75MG

A084327

001

0.5MG

A084991

001

0.75MG

A084993

001

1.5MG

A084990

001

4MG

A084992

001

0.5MG
0.75MG
1.5MG
4MG

N012675
N012675
N012675
N012675

004
007
009
010

EQ 8MG BASE/ML

N016675

001

EQ 8MG BASE/ML
EQ 16MG BASE/ML

A084315
A087711

001
001

N014242

001

N013413

001

N011983

002

N012071
N012071

002
004

A084342

001

A088448
A088469

001
001

A084493
A084282
A084752
A083161
A088522
A087065
A081125
A081126
A083702
A084355
A089169
A087668
A085606
A085641

001
001
001
001
001
001
001
001
001
001
001
001
001
001

N014694
N014694
N014694

002
003
004

DEXAMETHASONE ACETATE
INJECTABLE; INJECTION
DECADRON-LA
MERCK
DEXAMETHASONE ACETATE
WATSON LABS

May 24, 1982

DEXAMETHASONE SODIUM PHOSPHATE

AEROSOL; NASAL
DEXACORT
UCB INC
EQ 0.1MG PHOSPHATE/INH
AEROSOL, METERED; INHALATION
DEXACORT
EQ 0.1MG PHOSPHATE/INH
UCB INC
CREAM; TOPICAL
DECADRON
EQ 0.1% PHOSPHATE
MERCK
INJECTABLE; INJECTION
DECADRON
MERCK
EQ 4MG PHOSPHATE/ML
EQ 24MG PHOSPHATE/ML
DEXACEN-4

CENT PHARMS

EQ 4MG PHOSPHATE/ML
DEXAMETHASONE
ABRAXIS PHARM
EQ 4MG PHOSPHATE/ML
APP PHARMS
EQ 10MG PHOSPHATE/ML
DEXAMETHASONE SODIUM PHOSPHATE
AKORN
EQ 4MG PHOSPHATE/ML
BAXTER HLTHCARE
EQ 4MG PHOSPHATE/ML
BEL MAR
EQ 4MG PHOSPHATE/ML
DELL LABS
EQ 4MG PHOSPHATE/ML
INTL MEDICATION
EQ 20MG PHOSPHATE/ML
LYPHOMED
EQ 4MG PHOSPHATE/ML
TEVA PARENTERAL
EQ 4MG PHOSPHATE/ML
EQ 10MG PHOSPHATE/ML
WATSON LABS
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 10MG PHOSPHATE/ML
EQ 24MG PHOSPHATE/ML
WYETH AYERST
EQ 4MG PHOSPHATE/ML
HEXADROL
ORGANON USA INC
EQ 4MG PHOSPHATE/ML
EQ 10MG PHOSPHATE/ML
EQ 20MG PHOSPHATE/ML

Jan 25, 1984

Jan 25, 1984

Feb 17, 1984

Aug 31, 1990
Aug 31, 1990

Apr 09, 1986

Jul 01, 1982

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6 - 101 (of 346)

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

N011977

001

A088071

001

A083342

001

A088433

001

A084170
A084173

001
001

N011984

001

A084855

001

N013334

002

N050324

001

N050322

001

A064055

001

Oct 30, 1995

A062714
A062539

001
001

Jul 21, 1986

Jan 10, 1985

3.5MG BASE/GM;10,000 UNITS/GM

A062566

001

Feb 22, 1985

3.5MG BASE/GM;10,000 UNITS/GM

A062411

001

May 16, 1983

3.5MG BASE/ML;10,000 UNITS/ML

A062544

001

Oct 29, 1984

3.5MG BASE/ML;10,000 UNITS/ML

A062428

001

May 18, 1983

2MG/5ML

N011814

002

2MG

N011814

001

N012394

002

Dec 28, 1982

Dec 15, 1983

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 UNIVERSAL
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
0.1%;EQ
DEXASPORIN
PHARMAFAIR
0.1%;EQ
SUSPENSION/DROPS; OPHTHALMIC
DEXACIDIN
NOVARTIS
0.1%;EQ
DEXASPORIN
PHARMAFAIR
0.1%;EQ

DEXBROMPHENIRAMINE MALEATE
SYRUP; ORAL
DISOMER
SCHERING
TABLET; ORAL
DISOMER
SCHERING

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET; ORAL
DISOPHROL
SCHERING

2MG;60MG

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DISCONTINUED DRUG PRODUCT LIST

6 - 102 (of 346)

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;
BROMPHERIL
COPLEY PHARM
DISOBROM
SANDOZ
RESPORAL
PIONEER PHARMS

ORAL
6MG;120MG

A089116

001

Jan 22, 1987

6MG;120MG

A070770

001

Sep 30, 1991

6MG;120MG

A089139

001

Jun 16, 1988

A086837

001

Jul 19, 1982

A088682

001

Jan 17, 1986

A086835

001

A085355

001

A076814
A076814
A076814

001
002
003

A083902

001

A083735
A083735

001
002

A084935

001

A040299
A083930
A083903
A083903
A085652
A086521
A084125
A085370
A085371
A084986
A085892

001
001
001
003
001
001
001
001
001
001
001

A084051
A084051

001
002

A084001

001

A088913

001

Mar 02, 1987

N011265

002

Apr 02, 1984

DEXCHLORPHENIRAMINE MALEATE
SYRUP; ORAL
POLARAMINE
SCHERING
2MG/5ML
TABLET; ORAL
DEXCHLORPHENIRAMINE MALEATE
PLIVA
2MG
POLARAMINE
SCHERING
2MG

DEXTROAMPHETAMINE SULFATE
CAPSULE; ORAL
DEXAMPEX
TEVA
15MG
CAPSULE, EXTENDED RELEASE; ORAL
DEXTROAMPHETAMINE SULFATE
ABLE
5MG
10MG
15MG
ELIXIR; ORAL
DEXEDRINE
GLAXOSMITHKLINE
5MG/5ML
TABLET; ORAL
DEXAMPEX
TEVA
5MG
10MG
DEXEDRINE
GLAXOSMITHKLINE
5MG
DEXTROAMPHETAMINE SULFATE
ENDO PHARMS
5MG
HALSEY
10MG
LANNETT
5MG
10MG
15MG
MAST MM
5MG
PUREPAC PHARM
5MG
SANDOZ
5MG
10MG
VITARINE
5MG
10MG
DEXTROSTAT
SHIRE
5MG
10MG
FERNDEX
FERNDALE LABS
5MG

Aug 25, 2004

Aug 25, 2004
Aug 25, 2004

May 13, 1999

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL
PHERAZINE DM
HALSEY
15MG/5ML;6.25MG/5ML
PROMETHAZINE HYDROCHLORIDE AND DESTROMETHORPHAN HYDROBROMIDE
ANI PHARMS
15MG/5ML;6.25MG/5ML

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DISCONTINUED DRUG PRODUCT LIST

6 - 103 (of 346)

DEXTROSE
INJECTABLE; INJECTION
DEXTROSE 10% IN PLASTIC CONTAINER
B BRAUN
10GM/100ML
MILES
10GM/100ML
DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN
2.5GM/100ML
2.5GM/100ML
DEXTROSE 38.5% IN PLASTIC CONTAINER
ABBOTT
38.5GM/100ML
DEXTROSE 5% IN PLASTIC CONTAINER
DHL
5GM/100ML
DEXTROSE 60%
B BRAUN
60GM/100ML
DEXTROSE 60% IN PLASTIC CONTAINER
B BRAUN
60GM/100ML
BAXTER HLTHCARE
60GM/100ML
HOSPIRA
60GM/100ML
DEXTROSE 7.7% IN PLASTIC CONTAINER
B BRAUN
7.7GM/100ML

N018046
N018504

001
001

N018358
N019626

001
001

Feb 02, 1988

N018923

001

Sep 19, 1984

N019971

001

Sep 28, 1995

N017995

002

Sep 22, 1982

N017995
N020047
N019346

001
002
001

Jul 02, 1991

Jan 25, 1985

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
00ML;320MG/100ML

001

Dec 27, 1984

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
00ML;140MG/100ML

001

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 N018274
00ML;530MG/100ML;500MG/100ML

001

DEXTROSE; POTASSIUM CHLORIDE

INJECTABLE;
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN
POTASSIUM
B BRAUN

INJECTION
CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
5GM/100ML;37MG/100ML
CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
5GM/100ML;75MG/100ML
CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER
5GM/100ML;110MG/100ML
CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
5GM/100ML;220MG/100ML

N019699

001

Sep 29, 1989

N019699

002

Sep 29, 1989

N019699

003

Sep 29, 1989

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
/100ML;207MG/100ML

001

May 08, 1986

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
/100ML;91MG/100ML

001

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DISCONTINUED DRUG PRODUCT LIST

6 - 104 (of 346)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE; INJECTION
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
B BRAUN
DEXTROSE 5%, SODIUM
BAXTER HLTHCARE
DEXTROSE 5%, SODIUM
BAXTER HLTHCARE
DEXTROSE 5%, SODIUM
BAXTER HLTHCARE

CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%

5GM/100ML;75MG/100ML;200MG/100ML
N018268 009
CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
5GM/100ML;150MG/100ML;200MG/100ML
N018268 004
CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
5GM/100ML;220MG/100ML;200MG/100ML
N018268 005
CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
5GM/100ML;300MG/100ML;200MG/100ML
N018268 006
CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
5GM/100ML;75MG/100ML;330MG/100ML
N018268 011
Jan 18, 1986
CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
5GM/100ML;150MG/100ML;330MG/100ML
N018268 012
Jan 18, 1986
CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
5GM/100ML;220MG/100ML;330MG/100ML
N018268 013
Jan 18, 1986
CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER
5GM/100ML;300MG/100ML;330MG/100ML
N018268 014
Jan 18, 1986
CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%
5GM/100ML;75MG/100ML;450MG/100ML
N018268 010
CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
5GM/100ML;150MG/100ML;450MG/100ML
N018268 001
CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
5GM/100ML;220MG/100ML;450MG/100ML
N018268 002
CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
5GM/100ML;300MG/100ML;450MG/100ML
N018268 003
CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
5GM/100ML;224MG/100ML;450MG/100ML
N018008 003
CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
5GM/100ML;300MG/100ML;450MG/100ML
N018008 001
CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
5GM/100ML;75MG/100ML;450MG/100ML
N018008 002

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

N018386

001

N018229

001

N018047

001

N018030
N018096

001
001

N018376

001

N018055

001

N018030

005

N018030
N018399

004
001

N019482

001

Oct 04, 1985

N019486
N018501

001
001

Oct 04, 1985

N018030

003

N019484
N018030

001
002

Oct 04, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 105 (of 346)

DEXTROSE; SODIUM CHLORIDE

INJECTABLE; INJECTION
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
MILES
5GM/100ML;450MG/100ML
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABBOTT
5GM/100ML;900MG/100ML
B BRAUN
5GM/100ML;900MG/100ML
MILES
5GM/100ML;900MG/100ML

N018400

001

N019483
N018026
N018500

001
001
001

1MG
2MG
4MG
6MG

N012302
N012302
N012302
N012302

005
002
004
006

5MG/ML
10MG/ML
15MG/ML

N019082
N019082
N019082

001
002
003

Dec 29, 1989

Dec 29, 1989
Dec 29, 1989

60%

A087726

001

Sep 23, 1982

85%

N011620

002

76%

N010040

017

30%
60%

N016403
N016403

002
001

N010040

016

N010040

012

A087739

001

N010040

021

A087729

001

Sep 23, 1982

A087731

001

Sep 23, 1982

N016403

003

52%;8%

A087724

001

Sep 23, 1982

66%;10%

A087723

001

Sep 23, 1982

52%;8%

A088166

001

Jun 17, 1983

66%;10%

A086505

001

Oct 04, 1985

DEXTROTHYROXINE SODIUM
TABLET; ORAL
CHOLOXIN
ABBOTT

DEZOCINE
INJECTABLE; INJECTION
DALGAN
ASTRAZENECA

DIATRIZOATE MEGLUMINE
INJECTABLE; INJECTION
ANGIOVIST 282
BAYER HLTHCARE
CARDIOGRAFIN
BRACCO
DIATRIZOATE MEGLUMINE
BRACCO
HYPAQUE
GE HEALTHCARE

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%

Sep 23, 1982

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

INJECTABLE; INJECTION
ANGIOVIST 292
BAYER HLTHCARE
ANGIOVIST 370
BAYER HLTHCARE
DIATRIZOATE-60
INTL MEDICATION
HYPAQUE-76
GE HEALTHCARE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 106 (of 346)

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

INJECTABLE; INJECTION
HYPAQUE-M,75%
GE HEALTHCARE
HYPAQUE-M,90%
GE HEALTHCARE
MD-60
MALLINCKRODT
MD-76
MALLINCKRODT
RENOCAL-76
BRACCO
RENOGRAFIN-60
BRACCO
RENOVIST
BRACCO
RENOVIST II
BRACCO
SOLUTION; ORAL, RECTAL
GASTROVIST
BAYER HLTHCARE

50%;25%

N010220

003

60%;30%

N010220

002

52%;8%

A087074

001

66%;10%

A087073

001

66%;10%

A089347

001

52%;8%

N010040

006

34.3%;35%

N010040

020

28.5%;29.1%

N010040

019

66%;10%

A087728

001

N011386

001

N009561
N009561

003
001

A087075

001

A087725

001

N011386

003

N009561

002

N018179

001

N020648
N020648
N020648
N020648

002
003
004
005

Jul
Jul
Jul
Jul

29,
29,
29,
29,

1997
1997
1997
1997

A070662
A070311
A070312
A070313
A071308
A071309
A071310
A072370
A072371
A072397
A076815

001
001
001
001
001
001
001
001
001
001
001

Jun
Dec
Dec
Dec
Jul
Jul
Jul
Jan
Jan
Jan
Apr

25,
16,
16,
16,
17,
17,
17,
29,
29,
29,
15,

1986
1985
1985
1985
1987
1987
1987
1993
1993
1993
2004

Jun 01, 1988

Sep 23, 1982

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%

Sep 23, 1982

DIAZEPAM
CAPSULE, EXTENDED RELEASE; ORAL
VALRELEASE
ROCHE
15MG
GEL; RECTAL
DIASTAT
VALEANT
5MG/ML (5MG/ML)
10MG/2ML (5MG/ML)
15MG/3ML (5MG/ML)
20MG/4ML (5MG/ML)
INJECTABLE; INJECTION
DIAZEPAM
ABRAXIS PHARM
5MG/ML
BAXTER HLTHCARE
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
MARSAM PHARMS LLC
5MG/ML
5MG/ML
5MG/ML
PARENTA PHARMS
5MG/ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 107 (of 346)

DIAZEPAM
INJECTABLE; INJECTION
DIAZEPAM
US ARMY
WARNER CHILCOTT
WATSON LABS

DIZAC
PHARMACIA AND UPJOHN
VALIUM
ROCHE
TABLET; ORAL
DIAZEPAM
ACTAVIS ELIZABETH

DAVA PHARMS INC

DURAMED PHARMS BARR

FERNDALE LABS

HALSEY

IVAX SUB TEVA PHARMS

MARTEC USA LLC

PAR PHARM

PIONEER PHARMS

ROXANE

SANDOZ

TEVA PHARMS
WARNER CHILCOTT

WATSON LABS

Q-PAM
QUANTUM PHARMICS

5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML

N020124
A071613
A071614
A070911
A070912
A070930

001
001
001
001
001
001

Dec
Oct
Oct
Aug
Aug
Dec

05,
22,
22,
28,
28,
01,

1990
1987
1987
1986
1986
1986

5MG/ML

N019287

001

Jun 18, 1993

5MG/ML

N016087

001

2MG
5MG
10MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
2MG
5MG
10MG
5MG
2MG
5MG
10MG
2MG
5MG
10MG

A070781
A070706
A070707
A070227
A070228
A070894
A070895
A070896
A070903
A070904
A070905
A070987
A070996
A070956
A070360
A070361
A070362
A072402
A070462
A070463
A070464
A070787
A070788
A070776
A070356
A070357
A070358
A070302
A070303
A070304
A070153
A070209
A070210
A070222
A070456
A070457
A070458

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Mar
Mar
Mar
Sep
Sep
Aug
Aug
Aug
Apr
Apr
Apr
Aug
Aug
Aug
Sep
Sep
Sep
Apr
Feb
Feb
Feb
Aug
Aug
Aug
Jun
Jun
Jun
Dec
Dec
Dec
Nov
Sep
Sep
Sep
Nov
Nov
Nov

19,
19,
19,
26,
26,
27,
27,
27,
01,
01,
01,
15,
15,
15,
04,
04,
04,
25,
25,
25,
25,
02,
02,
02,
17,
17,
17,
20,
20,
20,
01,
04,
04,
04,
01,
01,
01,

1986
1986
1986
1985
1985
1986
1986
1986
1987
1987
1987
1986
1986
1986
1985
1985
1985
1989
1986
1986
1986
1988
1988
1988
1986
1986
1986
1985
1985
1985
1985
1985
1985
1985
1985
1985
1985

2MG
2MG
5MG
5MG
10MG
10MG

A070423
A072431
A070424
A072432
A070425
A072433

001
001
001
001
001
001

Dec
Apr
Dec
Apr
Dec
Apr

12,
29,
12,
29,
12,
29,

1985
1988
1985
1988
1985
1988

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DISCONTINUED DRUG PRODUCT LIST

6 - 108 (of 346)

DIAZOXIDE
CAPSULE; ORAL
PROGLYCEM
TEVA BRANDED PHARM
INJECTABLE; INJECTION
DIAZOXIDE
ABRAXIS PHARM
HYPERSTAT
SCHERING

50MG
100MG

N017425
N017425

001
002

15MG/ML

A071519

001

15MG/ML

N016996

001

N006203

001

50MG

N011366

001

25MG

N020142

001

Nov 24, 1993

50MG
50MG
50MG

A075470
A075582
A075152

001
001
001

Feb 21, 2002

Feb 23, 2001
Nov 27, 1998

N020809

001

May 04, 1998

A074986
A074986
A074432
A074432
A074391
A074391
A074391
A074723
A074390
A074459
A074459
A074459

001
002
002
003
001
002
003
001
001
001
002
003

Feb
Feb
Jul
Jul
Jun
Jun
Jun
Mar
Aug
Jun
Jun
Jun

N019201
N019201
N019201

001
002
003

Jul 28, 1988

Jul 28, 1988
Jul 28, 1988

BASE
BASE
BASE
BASE

A060254
A062238
A060254
A062238

002
001
003
002

EQ 250MG BASE
EQ 500MG BASE

N050011
N050011

002
003

Aug 26, 1987

DIBUCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
HEAVY SOLUTION NUPERCAINE
NOVARTIS
2.5MG/ML

DICHLORPHENAMIDE
TABLET; ORAL
DARANIDE
TARO

DICLOFENAC POTASSIUM
TABLET; ORAL
CATAFLAM
NOVARTIS
DICLOFENAC POTASSIUM
MUTUAL PHARM
SANDOZ
WATSON LABS

DICLOFENAC SODIUM
SOLUTION/DROPS; OPHTHALMIC
DICLOFENAC SODIUM
FALCON PHARMS
0.1%
TABLET, DELAYED RELEASE; ORAL
DICLOFENAC SODIUM
NOSTRUM LABS
50MG
75MG
PLIVA
50MG
75MG
ROXANE
25MG
50MG
75MG
TEVA
50MG
75MG
TEVA PHARMS
25MG
50MG
75MG
VOLTAREN
NOVARTIS
25MG
50MG
75MG

26,
26,
29,
29,
29,
29,
29,
30,
15,
25,
25,
25,

1999
1999
1999
1999
1995
1995
1995
1999
1996
1997
1997
1997

DICLOXACILLIN SODIUM
CAPSULE; ORAL
DYCILL
GLAXOSMITHKLINE

PATHOCIL
WYETH AYERST

EQ
EQ
EQ
EQ

250MG
250MG
500MG
500MG

Mar 28, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 109 (of 346)

DICLOXACILLIN SODIUM
FOR SUSPENSION; ORAL
DICLOXACILLIN SODIUM
APOTHECON
DYNAPEN
APOTHECON
PATHOCIL
WYETH AYERST

EQ 62.5MG BASE/5ML

A061455

001

EQ 62.5MG BASE/5ML

N050337

002

EQ 62.5MG BASE/5ML

N050092

001

25MG
50MG

N005509
N005509

003
001

25MG
50MG
100MG

N005545
N005545
N005545

003
004
005

A084505
A089361
A083179

001
001
001

Oct 21, 1986

Jan 10, 1989
Feb 12, 1986

A080614

001

Feb 11, 1986

A084479

001

A084600
A088585
A084361

001
001
001

Jul 29, 1985

Aug 20, 1986
Feb 06, 1986

100MG/PACKET
167MG/PACKET
250MG/PACKET
375MG/PACKET

N020155
N020155
N020155
N020155

003
004
005
006

Oct
Oct
Oct
Oct

09,
09,
09,
09,

1991
1991
1991
1991

25MG
50MG
100MG
150MG
200MG

N020154
N020154
N020154
N020154
N020154

002
003
004
005
006

Oct
Oct
Oct
Oct
Oct

09,
09,
09,
09,
28,

1991
1991
1991
1991
1999

0.01%

N006110

005

0.01%

A083518

001

0.01%

A084436

001

0.7MG

A083517

001

DICUMAROL
CAPSULE; ORAL
DICUMAROL
LILLY
TABLET; ORAL
DICUMAROL
ABBOTT

DICYCLOMINE HYDROCHLORIDE
CAPSULE; ORAL
DICYCLOMINE HYDROCHLORIDE
MUTUAL PHARM
10MG
PIONEER PHARMS
10MG
WATSON LABS
10MG
INJECTABLE; INJECTION
DICYCLOMINE HYDROCHLORIDE
WATSON LABS
10MG/ML
SYRUP; ORAL
DICYCLOMINE HYDROCHLORIDE
ALPHARMA US PHARMS
10MG/5ML
TABLET; ORAL
DICYCLOMINE HYDROCHLORIDE
MUTUAL PHARM
20MG
PIONEER PHARMS
20MG
WATSON LABS
20MG

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
SUPPOSITORY; VAGINAL
DV
SANOFI AVENTIS US

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DISCONTINUED DRUG PRODUCT LIST

6 - 110 (of 346)

DIETHYLCARBAMAZINE CITRATE
TABLET; ORAL
HETRAZAN
LEDERLE

50MG

N006459

001

A085916
A088642
A088267
A088268
A085544
A085741

001
001
001
001
001
001

N017668

001

N011673

001

N017669

001

N017956

001

0.2MG/ML
0.5MG/ML
1MG/ML
5MG/ML

N004056
N004056
N004056
N004056

003
004
005
006

0.1MG
0.5MG

N004040
N004040

001
002

0.1MG
0.5MG

N004056
N004056

001
002

0.1MG
0.5MG
1MG
5MG

N004041
N004041
N004041
N004041

002
003
004
005

0.5MG
1MG
5MG

A083004
A083002
A083006

001
001
001

N004056
N004056
N004056
N004056
N004056

007
017
008
009
010

N004039
N004039
N004039
N004039
N004039

002
005
003
004
006

A083003
A083005

001
001

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

SUPPOSITORY; VAGINAL
DIETHYLSTILBESTROL
LILLY
STILBESTROL
BRISTOL MYERS SQUIBB
TABLET; ORAL
DIETHYLSTILBESTROL
LILLY

STILBESTROL
TABLICAPS

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

Sep 20, 1984

Aug 25, 1983
Aug 25, 1983

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DISCONTINUED DRUG PRODUCT LIST

6 - 111 (of 346)

DIETHYLSTILBESTROL
TABLET, DELAYED RELEASE; ORAL
STILBESTROL
TABLICAPS
5MG
STILBETIN
BRISTOL MYERS SQUIBB 0.1MG
0.5MG
1MG
5MG

A083007

001

N004056
N004056
N004056
N004056

011
012
013
014

250MG/5ML

N010010

001

50MG

N010010

002

0.05%

N017741

001

0.05%

N019259

001

Aug 28, 1985

0.05%

N020205

001

Nov 20, 1992

0.05%

N019260

001

Aug 28, 1985

0.05%

N017994

001

250MG
500MG
250MG
500MG
500MG
250MG
250MG
500MG

A074285
A074285
A073562
A073563
A074604
A073679
A074400
A074400

001
002
001
001
001
001
001
002

May
May
Nov
Nov
Jun
Jul
Jul
Jul

250MG
500MG

N018445
N018445

001
002

Apr 19, 1982

Apr 19, 1982

0.2MG/ML

A084100

005

0.05MG
0.1MG
0.15MG
0.2MG

N018118
N018118
N018118
N018118

002
003
004
001

Jul
Jul
Sep
Jul

0.25MG/ML
0.25MG/ML

A083217
A040206

001
001

Aug 28, 1998

DIETHYLSTILBESTROL DIPHOSPHATE
INJECTABLE; INJECTION
STILPHOSTROL
BAYER PHARMS
TABLET; ORAL
STILPHOSTROL
BAYER PHARMS

DIFLORASONE DIACETATE
CREAM; TOPICAL
FLORONE
PHARMACIA AND UPJOHN
FLORONE E
PHARMACIA AND UPJOHN
PSORCON
SANOFI AVENTIS US
OINTMENT; TOPICAL
PSORCON
PHARMACIA AND UPJOHN
PSORCON E
PHARMACIA AND UPJOHN

DIFLUNISAL
TABLET; ORAL
DIFLUNISAL
PUREPAC PHARM
ROXANE
SANDOZ
TEVA
WATSON LABS
DOLOBID
MERCK

07,
07,
27,
27,
10,
31,
17,
17,

1996
1996
1992
1992
1996
1992
1997
1997

DIGITOXIN
INJECTABLE; INJECTION
CRYSTODIGIN
LILLY

DIGOXIN
CAPSULE; ORAL
LANOXICAPS
GLAXOSMITHKLINE LLC

INJECTABLE; INJECTION
DIGOXIN
ABRAXIS PHARM
HOSPIRA

26,
26,
24,
26,

1982
1982
1984
1982

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DISCONTINUED DRUG PRODUCT LIST

6 - 112 (of 346)

DIGOXIN
INJECTABLE; INJECTION
DIGOXIN
WYETH AYERST
DIGOXIN PEDIATRIC
HOSPIRA
TABLET; ORAL
DIGOXIN
ACTAVIS TOTOWA
LANOXIN
COVIS PHARMA

0.25MG/ML

A084386

001

0.1MG/ML

A040092

001

Apr 25, 1996

0.125MG
0.25MG

A040282
A040282

001
002

Dec 23, 1999

Dec 23, 1999

0.0625MG
0.1875MG
0.375MG
0.5MG

N020405
N020405
N020405
N020405

001
003
005
006

Sep
Sep
Sep
Sep

N018885

001

Nov 30, 1984

N018885

002

Nov 30, 1984

N019471
N019471
N019471
N019471

001
002
003
004

Jan
Jan
Jan
Jan

23,
23,
23,
23,

1989
1989
1989
1989

A074845
A074845
A074845
N020939
N020939
N020939
N020939
N020939
N020939
A074079
A074079
A074079

001
002
003
001
002
003
004
005
006
001
002
003

Sep
Sep
Sep
Jan
Jan
Jan
Jan
Sep
Sep
Nov
Nov
Nov

15,
15,
15,
28,
28,
28,
28,
14,
14,
30,
30,
30,

1999
1999
1999
2000
2000
2000
2000
2001
2001
1993
1993
1993

N020792
N020027
N020027

001
001
003

Sep 05, 1997

Oct 24, 1991
Aug 18, 1995

A075004
A075106

001
001

Feb 16, 2000

Apr 29, 1999

A074051
A074051
A074051
A074051
A074168
A074168
A074168
A074168
A074084
A074084

001
002
003
004
001
002
003
004
001
002

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Feb
Feb

30,
30,
30,
30,

1997
1997
1997
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

DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
CARDIZEM SR
BIOVAIL
60MG
90MG
120MG
180MG
DILTIAZEM HYDROCHLORIDE
BIOVAIL
60MG
90MG
120MG
120MG
180MG
240MG
300MG
360MG
420MG
TEVA
60MG
90MG
120MG
INJECTABLE; INJECTION
CARDIZEM
BIOVAIL
100MG/VIAL
BIOVAIL LABS INTL
5MG/ML
25MG/VIAL
DILTIAZEM HYDROCHLORIDE
HOSPIRA
5MG/ML
5MG/ML
TABLET; ORAL
DILTIAZEM HYDROCHLORIDE
APOTHECON
30MG
60MG
90MG
120MG
IVAX SUB TEVA PHARMS 30MG
60MG
90MG
120MG
TEVA
30MG
60MG

31,
31,
31,
31,
03,
03,
03,
03,
25,
25,

1993
1993
1993
1993
1995
1995
1995
1995
1994
1994

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6 - 113 (of 346)

DILTIAZEM HYDROCHLORIDE
TABLET; ORAL
DILTIAZEM HYDROCHLORIDE
TEVA PHARMS
30MG
60MG
90MG
120MG

A074067
A074067
A074067
A074067

001
002
003
004

Nov
Nov
Nov
Nov

05,
05,
05,
05,

1992
1992
1992
1992

N020506
N020506
N020506

001
002
003

Oct 04, 1996

Oct 04, 1996
Oct 04, 1996

N020507

001

Oct 04, 1996

50MG/ML
50MG/ML
50MG/ML

A084767
A083531
A084316

001
001
001

12.5MG/4ML

A080715

001

50MG
50MG
50MG

A080841
A085985
A085166

001
001
001

0.92MG/VIAL;0.092MG/VIAL

N021191

001

EQ 5MG BASE/ML

N017434

001

100MG

N008114

004

N005845
N005845

007
001

A080519
A080519
A083275
A085701
A085701
A087914
A084524

004
003
001
001
002
001
001

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
EQ 180MG HCL;5MG

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

May 31, 2002

DINOPROST TROMETHAMINE
INJECTABLE; INJECTION
PROSTIN F2 ALPHA
PHARMACIA AND UPJOHN

DIPHEMANIL METHYLSULFATE
TABLET; ORAL
PRANTAL
SCHERING

DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL
BENADRYL
MCNEIL CONS

25MG
50MG
DIPHENHYDRAMINE HYDROCHLORIDE
ALRA
25MG
50MG
ANABOLIC
50MG
ELKINS SINN
25MG
50MG
HALSEY
50MG
HEATHER
25MG

Jun 04, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 114 (of 346)

DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE; ORAL
DIPHENHYDRAMINE HYDROCHLORIDE
HEATHER
50MG
IMPAX LABS
25MG
50MG
IVAX SUB TEVA PHARMS 25MG
50MG
LANNETT
25MG
50MG
LEDERLE
25MG
50MG
LNK
25MG
50MG
MK LABS
25MG
50MG
MUTUAL PHARM
25MG
25MG
50MG
NEWTRON PHARMS
25MG
50MG
NEXGEN PHARMA INC
25MG
PERRIGO
25MG
50MG
PIONEER PHARMS
25MG
50MG
PUREPAC PHARM
25MG
50MG
PVT FORM
25MG
50MG
ROXANE
50MG
SANDOZ
25MG
25MG
50MG
50MG
SUPERPHARM
25MG
50MG
TEVA
25MG
50MG
VALEANT PHARM INTL
25MG
50MG
VANGARD
25MG
50MG
WATSON LABS
25MG
25MG
25MG
50MG
50MG
50MG
WEST WARD
50MG
WHITEWORTH TOWN PLSN 25MG
50MG
ELIXIR; ORAL
BELIX
HALSEY
12.5MG/5ML
BENADRYL
MCNEIL CONS
12.5MG/5ML
DIBENIL
CENCI
12.5MG/5ML
DIPHEN
USL PHARMA
12.5MG/5ML
DIPHENHYDRAMINE HYDROCHLORIDE
BUNDY
12.5MG/5ML

A083953
A080807
A080807
A080762
A080762
A080868
A080868
A086874
A086875
A087977
A087978
A083087
A083087
A084506
A089488
A089489
A086543
A086544
A083634
A083061
A083061
A089101
A088880
A085156
A085150
A083027
A083027
A080635
A080832
A080845
A080832
A080845
A089040
A089041
A085874
A085874
A080596
A080592
A088034
A087630
A080728
A083797
A085138
A080727
A083797
A085083
A083567
A083441
A080800

001
001
002
001
002
001
002
001
001
001
001
001
002
001
001
001
001
001
001
001
002
001
001
001
001
001
002
001
001
002
002
001
001
001
001
002
001
001
001
001
001
001
001
001
002
001
001
001
001

A086586

001

N005845

004

A088304

001

A084640

001

A083674

001

Jan 27, 1983

Jan 27, 1983

Jan 02, 1987

Jan 02, 1987

Dec 20, 1985

Dec 20, 1985

May 15, 1985

May 15, 1985

Oct 27, 1982

Oct 03, 1983

Dec 16, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 115 (of 346)

DIPHENHYDRAMINE HYDROCHLORIDE
ELIXIR; ORAL
DIPHENHYDRAMINE HYDROCHLORIDE
CENCI
12.5MG/5ML
KV PHARM
12.5MG/5ML
LANNETT
12.5MG/5ML
LEDERLE
12.5MG/5ML
MK LABS
12.5MG/5ML
NASKA
12.5MG/5ML
PERRIGO
12.5MG/5ML
PUREPAC PHARM
12.5MG/5ML
PVT FORM
12.5MG/5ML
ROXANE
12.5MG/5ML
HYDRAMINE
ALPHARMA US PHARMS
12.5MG/5ML
INJECTABLE; INJECTION
BENADRYL
MCNEIL CONS
10MG/ML
DIPHENHYDRAMINE HYDROCHLORIDE
BAXTER HLTHCARE
50MG/ML
BEL MAR
10MG/ML
LYPHOMED
10MG/ML
WATSON LABS
10MG/ML
WYETH AYERST
50MG/ML
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
ABRAXIS PHARM
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
12.5MG/5ML
CUMBERLAND SWAN
12.5MG/5ML
HI TECH PHARMA
12.5MG/5ML
HYDRAMINE
ALPHARMA US PHARMS
12.5MG/5ML
SILPHEN
SILARX
12.5MG/5ML
VICKS FORMULA 44
WARNER CHILCOTT
12.5MG/5ML

A087941
A085621
A080939
A086937
A083088
A088680
A083063
A083237
A085287
A080643

001
001
002
001
002
001
001
001
001
001

Dec 17, 1982

A080763

002

N006146

001

A083183
A080822
A087066
A083533
A080577

001
001
001
001
001

A080586

002

A071292

001

Apr 10, 1987

A089179

001

Jun 05, 1986

N006514

004

A070118

001

Oct 01, 1985

A070497
A073611
A072416

001
001
001

Apr 25, 1989

Aug 20, 1992
Sep 28, 1990

A070205

001

Jan 28, 1986

A072646

001

Feb 27, 1992

A070524

001

Jan 14, 1987

12.5MG/5ML;30MG/5ML

N019014

001

Jun 11, 1985

EQ 25MG BASE

N016033

001

N011945

001

May 31, 1985

Jan 25, 1982

DIPHENHYDRAMINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION; ORAL
BENYLIN
PARKE DAVIS

DIPHENIDOL HYDROCHLORIDE
TABLET; ORAL
VONTROL
GLAXOSMITHKLINE

DIPHENYLPYRALINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
HISPRIL
GLAXOSMITHKLINE
5MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 116 (of 346)

DIPIVEFRIN HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
DIPIVEFRIN HYDROCHLORIDE
BAUSCH AND LOMB
0.1%

A074188

001

May 19, 1995

5MG/ML

A074601

001

Dec 19, 1997

5MG/ML

N019817

001

Dec 13, 1990

50MG
75MG
25MG
50MG
75MG

A089426
A089427
A086944
A087562
A087561

001
001
002
001
001

Jul
Jul
Apr
Feb
Feb

N050678

001

Jun 19, 1995

A071190
A071191
A070186
A070187
A070351
A070352
A070138
A070139
A070470
A070471
A070940
A070941
A070240
A070241

001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jan
Jan
Nov
Nov
Dec
Dec
Jun
Jun
Dec
Dec
Feb
Feb
Feb
Feb

250MG
500MG

N007883
N007883

003
002

250MG
500MG
250MG
250MG
500MG
500MG

A088792
A088793
A086889
A087973
A086890
A087974

001
001
001
001
001
001

N019794
N019794

001
002

DIPYRIDAMOLE
INJECTABLE; INJECTION
DIPYRIDAMOLE
HOSPIRA
IV PERSANTINE
BOEHRINGER INGELHEIM
TABLET; ORAL
DIPYRIDAMOLE
PUREPAC PHARM
SANDOZ

12,
12,
16,
25,
25,

1990
1990
1991
1992
1992

DIRITHROMYCIN
TABLET, DELAYED RELEASE; ORAL
DYNABAC
LILLY RES LABS
250MG

DISOPYRAMIDE PHOSPHATE
CAPSULE; ORAL
DISOPYRAMIDE PHOSPHATE
INTERPHARM
IVAX SUB TEVA PHARMS
MUTUAL PHARM
MYLAN
SANDOZ
SUPERPHARM
WATSON LABS

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

100MG
150MG
100MG
150MG
100MG
150MG
100MG
150MG
100MG
150MG
100MG
150MG
100MG
150MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

15,
15,
18,
18,
17,
17,
14,
14,
10,
10,
09,
09,
02,
02,

1987
1987
1985
1985
1985
1985
1985
1985
1985
1985
1987
1987
1986
1986

DISULFIRAM
TABLET; ORAL
ANTABUSE
TEVA WOMENS
DISULFIRAM
PAR PHARM
WATSON LABS

Aug 14, 1984

Aug 14, 1984
Aug 05, 1983
Aug 05, 1983

DIVALPROEX SODIUM
TABLET, DELAYED RELEASE; ORAL
DEPAKOTE CP
ABBOTT
EQ 250MG BASE
EQ 500MG BASE

Jul 11, 1990

Jul 11, 1990

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 117 (of 346)

DOBUTAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
DOBUTAMINE HYDROCHLORIDE
ASTRAZENECA
EQ
BAXTER HLTHCARE
EQ
HOSPIRA
EQ
LUITPOLD
EQ
MARSAM PHARMS LLC
EQ
EQ
TEVA PARENTERAL
EQ
DOBUTREX
LILLY
EQ

12.5MG
12.5MG
1.25GM
12.5MG
12.5MG
12.5MG
12.5MG

BASE/ML
BASE/ML
BASE/100ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

12.5MG BASE/ML

A074098
A074381
A074634
A074545
A074279
A074995
A074206

001
001
001
001
001
001
001

Feb
Sep
Sep
Jun
Feb
Mar
Oct

21,
26,
27,
25,
18,
31,
19,

1995
1996
1996
1998
1998
1998
1993

N017820

002

N020449

001

May 14, 1996

N021719

001

Oct 18, 2004

A077975
A077975

002
001

Dec 11, 2009

Dec 11, 2009

A070656
A070657
A070012
A070058
A070013
A070059
A070364
A070087
N018656
A070089
A070090
A070091
A070092
A070093
A070094
N018398
N018398
A074403
N018014
N018549
A070011
A070046
A070047
A072999
A073000
A070558
N018138
A070559

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001
001
001

Jan
Jan
Jun
Mar
Jun
Mar
Dec
Oct
Jun
Oct
Oct
Oct
Oct
Oct
Oct

N020542

001

N017395
N017395

001
002

DOCETAXEL
INJECTABLE; INJECTION
TAXOTERE
SANOFI AVENTIS US

40MG/ML

DONEPEZIL HYDROCHLORIDE
SOLUTION; ORAL
ARICEPT
EISAI INC
5MG/5ML
TABLET, ORALLY DISINTEGRATING; ORAL
DONEPEZIL HYDROCHLORIDE
MUTUAL PHARM
5MG
10MG

DOPAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
DOPAMINE HYDROCHLORIDE
ABBOTT

40MG/ML
80MG/ML
ABRAXIS PHARM
40MG/ML
40MG/ML
80MG/ML
80MG/ML
160MG/ML
ASTRAZENECA
40MG/ML
40MG/ML
80MG/ML
80MG/ML
80MG/ML
160MG/ML
160MG/ML
160MG/ML
BAXTER HLTHCARE
40MG/ML
80MG/ML
HOSPIRA
40MG/ML
INTL MEDICATION
40MG/ML
LYPHOMED
40MG/ML
SMITH AND NEPHEW
40MG/ML
40MG/ML
80MG/ML
TEVA PARENTERAL
40MG/ML
80MG/ML
WARNER CHILCOTT
40MG/ML
40MG/ML
80MG/ML
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%
HOSPIRA
1.6MG/ML
INTROPIN
HOSPIRA
40MG/ML
80MG/ML

24,
24,
12,
20,
12,
20,
04,
23,
28,
23,
23,
23,
23,
23,
23,

1989
1989
1985
1985
1985
1985
1985
1985
1983
1985
1985
1985
1985
1985
1985

Mar 22, 1982

May 23, 1996
Mar
Aug
Aug
Aug
Oct
Oct
Sep

11,
29,
29,
29,
23,
23,
20,

1983
1985
1985
1985
1991
1991
1985

Sep 20, 1985

Aug 30, 1995

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 118 (of 346)

DOPAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
INTROPIN
HOSPIRA

160MG/ML

N017395

003

EQ 1MG BASE/ML

N019946

001

Mar 07, 1991

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
2MG
4MG
8MG
1MG
1MG
2MG
2MG
4MG
4MG
8MG
8MG
1MG
2MG
4MG
8MG

A075574
A075574
A075574
A075574
A075466
A075466
A075466
A075466
A075453
A075453
A075453
A075453
A075432
A075646
A075432
A075646
A075432
A075646
A075432
A075646
A075353
A075353
A075353
A075353

001
002
003
004
001
002
003
004
001
002
003
004
001
001
002
002
003
003
004
004
001
002
003
004

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Jan
Jan
Jan
Jan

18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
18,
12,
12,
12,
12,

2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2001
2001
2001
2001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

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

A071685
A071686
A071673
A071674
A071675
A071676
A071502
A071653
A071654
A071521
N016987
N016987
N016987
N016987
N016987
N016987
A073054
A072109
A073055
A072386
A072110
A072387

001
001
001
001
001
001
001
001
001
001
001
002
003
006
004
007
001
001
001
001
001
001

Jan
Jan
Jan
Jan
Jan
Jan
Feb
Feb
Feb
Feb

05,
05,
05,
05,
05,
05,
18,
18,
18,
18,

1988
1988
1988
1988
1988
1988
1988
1988
1988
1988

Apr
Dec
Dec
Dec
Sep
Sep
Sep

13,
28,
28,
28,
08,
08,
08,

1987
1990
1990
1990
1988
1988
1988

DOXACURIUM CHLORIDE
INJECTABLE; INJECTION
NUROMAX
ABBOTT

DOXAZOSIN MESYLATE
TABLET; ORAL
DOXAZOSIN MESYLATE
ACTAVIS ELIZABETH

GENPHARM

IVAX SUB TEVA PHARMS

SANDOZ

TEVA

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

DOXEPIN HYDROCHLORIDE
CAPSULE; ORAL
DOXEPIN HYDROCHLORIDE
CLONMEL HLTHCARE

MUTUAL PHARM

NEW RIVER

PUREPAC PHARM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 119 (of 346)

DOXEPIN HYDROCHLORIDE
CAPSULE; ORAL
DOXEPIN HYDROCHLORIDE
QUANTUM PHARMICS

SANDOZ

WATSON LABS

SINEQUAN
PFIZER

CONCENTRATE; ORAL
SINEQUAN
PFIZER

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

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

A070972
A070973
A070931
A070932
A072375
A072376
A071487
A070827
A070828
A070825
A071562
A070952
A072985
A070953
A072986
A070954
A072987
A071763
A070955
A071764

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Sep
Sep
Sep
Sep
Mar
Mar
Mar
May
May
May
Mar
Mar
Mar
May
Mar
May
Mar
Feb
May
Feb

29,
29,
29,
29,
15,
15,
02,
15,
15,
15,
02,
04,
29,
15,
29,
15,
29,
09,
15,
09,

1987
1987
1987
1987
1989
1989
1987
1986
1986
1986
1987
1987
1991
1986
1991
1986
1991
1988
1986
1988

EQ
EQ
EQ
EQ
EQ
EQ

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

N016798
N016798
N016798
N016798
N016798
N016798

003
001
002
006
005
007

EQ 10MG BASE/ML

N017516

001

2MG/ML
2MG/ML
200MG/100ML
200MG/100ML

A063165
N050629
A063165
N050629

001
001
002
002

Jan
Dec
Jan
May

30,
23,
30,
03,

1991
1987
1991
1988

10MG/VIAL
20MG/VIAL
50MG/VIAL
150MG/VIAL

N050467
N050467
N050467
N050467

001
003
002
004

10MG/VIAL
50MG/VIAL
100MG/VIAL

A062926
A062926
A062926

001
002
003

Apr 13, 1989

Apr 13, 1989
Apr 13, 1989

EQ 75MG BASE

A065055

004

Apr 18, 2005

EQ 25MG BASE/5ML

A061720

001

EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE

A065471
A065471
A065471

001
002
003

DOXORUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
ADRIAMYCIN PFS
PHARMACIA AND UPJOHN

ADRIAMYCIN RDF
PHARMACIA AND UPJOHN

RUBEX
BRISTOL MYERS SQUIBB

May 20, 1985

Jul 22, 1987

DOXYCYCLINE
CAPSULE; ORAL
DOXYCYCLINE
PAR PHARM
FOR SUSPENSION; ORAL
DOXYCHEL
RACHELLE
TABLET; ORAL
DOXYCYCLINE
MUTUAL PHARM

Apr 17, 2009

Apr 17, 2009
Apr 17, 2009

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 120 (of 346)

DOXYCYCLINE HYCLATE
CAPSULE; ORAL
DOXYCYCLINE HYCLATE
HALSEY
HEATHER
INTERPHARM
MUTUAL PHARM
MYLAN
PAR PHARM
PVT FORM
RANBAXY
SUPERPHARM
WARNER CHILCOTT
WATSON LABS

DOXY-LEMMON
TEVA

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

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

A062119
A062119
A062463
A062463
A062763
A062763
A062418
A062418
A062337
A062337
A062434
A062442
A062631
A062631
A062479
A062479
A062469
A062469
A062594
A062594
A061717
A062142
A061717
A062142

002
001
001
002
001
002
001
002
001
002
001
001
001
002
001
002
001
002
001
002
001
001
002
002

May
May
Dec
Dec
Sep
Sep
Jan
Jan
Mar
Mar
Oct
Dec
Jul
Jul
Dec
Dec
Oct
Oct
Dec
Dec

EQ 50MG BASE
EQ 100MG BASE

A062497
A062497

001
002

Aug 23, 1984

Jun 15, 1984

N050744

001

Sep 30, 1998

A063187

001

Jun 30, 1992

N050582
N050582
A062653

002
001
001

Aug 13, 2001

Jul 22, 1985
Oct 30, 1985

A061953

001

A062450
A062450
A062569

001
002
002

Oct 27, 1983

Oct 27, 1983
Mar 09, 1988

A062992
A062992

001
002

Feb 16, 1989

Feb 16, 1989

N050442
N050442

002
001

A062462
A062764
A065287
A062391
A062432
A062494
A062269
A062269
A062593

001
001
001
001
001
001
003
002
001

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
BAXTER HLTHCARE
EQ 100MG BASE/VIAL
EQ 200MG BASE/VIAL
BEDFORD
EQ 200MG BASE/VIAL
DOXYCYCLINE HYCLATE
BAXTER HLTHCARE
EQ 100MG BASE/VIAL
EQ 200MG BASE/VIAL
VIBRAMYCIN
PFIZER
EQ 100MG BASE/VIAL
EQ 200MG BASE/VIAL
TABLET; ORAL
DOXYCYCLINE HYCLATE
HEATHER
EQ 100MG BASE
INTERPHARM
EQ 100MG BASE
LARKEN LABS
EQ 20MG BASE
MUTUAL PHARM
EQ 100MG BASE
MYLAN
EQ 100MG BASE
SUPERPHARM
EQ 100MG BASE
TRUXTON INC
EQ 50MG BASE
EQ 100MG BASE
WARNER CHILCOTT
EQ 100MG BASE

May
Sep
Feb
Sep
Feb
Feb

24,
24,
07,
07,
02,
02,
28,
28,
29,
29,
19,
22,
24,
24,
23,
23,
31,
31,
05,
05,

11,
02,
28,
30,
15,
20,

1985
1985
1983
1983
1988
1988
1983
1983
1982
1982
1984
1983
1986
1986
1983
1983
1984
1984
1985
1985

1983
1988
2006
1982
1983
1985

Nov 08, 1982

Aug 28, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 121 (of 346)

DOXYCYCLINE HYCLATE
TABLET; ORAL
DOXYCYCLINE HYCLATE
WATSON LABS
DOXY-LEMMON
TEVA
VIBRA-TABS
PFIZER

EQ 50MG BASE
EQ 100MG BASE

A062392
A062392

001
002

Mar 31, 1983

Mar 31, 1983

EQ 100MG BASE

A062581

001

Mar 15, 1985

EQ 100MG BASE

N050533

001

25MG

N019440

001

12.5MG
25MG

N006412
N006412

015
014

25MG
25MG

A088900
A088603

002
001

Feb 12, 1988

Aug 07, 1984

25MG

A070156

001

Jul 02, 1987

N010598

002

50MG/ML

N012936

001

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
A070993
A072018
A072019
A072020
A072021
A071645
A072272
A072335
A071750
A071754
A071755
A073520
A073521
A073523

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Nov
Nov
Oct
Oct
Oct
Oct
Apr
Aug
Oct
Sep
Sep
Sep
Nov
Nov
Nov

17,
17,
20,
19,
19,
19,
07,
31,
24,
06,
06,
06,
27,
27,
27,

1986
1986
1988
1988
1988
1988
1988
1995
1988
1988
1988
1988
1991
1991
1991

BASE/ML
BASE/ML
BASE/ML
BASE/ML

A072026
A072027
A072028
A071982

001
001
001
001

Apr
Apr
Apr
May

13,
13,
13,
04,

1989
1989
1989
1988

0.05MG BASE/ML

N016049

001

DOXYLAMINE SUCCINATE
CAPSULE; ORAL
UNISOM
PFIZER
TABLET; ORAL
DECAPRYN
SANOFI AVENTIS US
DOXYLAMINE SUCCINATE
COPLEY PHARM
QUANTUM PHARMICS
DOXY-SLEEP-AID
PAR PHARM

Feb 05, 1986

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE; ORAL
BENDECTIN
SANOFI AVENTIS US
10MG;10MG

DROMOSTANOLONE PROPIONATE
INJECTABLE; INJECTION
DROLBAN
LILLY

DROPERIDOL
INJECTABLE; INJECTION
DROPERIDOL
ABRAXIS PHARM
ASTRAZENECA

HOSPIRA
LUITPOLD
SMITH AND NEPHEW
SOLOPAK
WATSON LABS

DROPERIDOL; FENTANYL CITRATE

INJECTABLE; INJECTION
FENTANYL CITRATE AND DROPERIDOL
ASTRAZENECA
2.5MG/ML;EQ
2.5MG/ML;EQ
2.5MG/ML;EQ
HOSPIRA
2.5MG/ML;EQ
INNOVAR
AKORN MFG
2.5MG/ML;EQ

0.05MG
0.05MG
0.05MG
0.05MG

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DISCONTINUED DRUG PRODUCT LIST

6 - 122 (of 346)

DYCLONINE HYDROCHLORIDE
SOLUTION; TOPICAL
DYCLONE
ASTRAZENECA

0.5%
1%

N009925
N009925

002
001

5MG
10MG

N017388
N017388

001
002

160MG/15ML

N007794

003

250MG/ML

N009088

001

200MG

A084514

001

400MG

A084751

001

200MG
400MG

N007794
N007794

001
002

0.03%
0.06%
0.25%

N011963
N011963
N011963

002
004
003

1%

N018751

001

N008922

002

150MG/ML

A084356

001

150MG/ML

A080391

001

200MG/ML

N010573

001

A040131
A040044

001
001

Feb 24, 1998

Mar 20, 1996

A040043

001

Mar 20, 1996

A089624

001

May 13, 1988

DYDROGESTERONE
TABLET; ORAL
GYNOREST
SOLVAY

DYPHYLLINE
ELIXIR; ORAL
NEOTHYLLINE
TEVA
INJECTABLE; INJECTION
NEOTHYLLINE
TEVA
TABLET; ORAL
DILOR
SAVAGE LABS
DILOR-400
SAVAGE LABS
NEOTHYLLINE
TEVA

ECHOTHIOPHATE IODIDE
FOR SOLUTION; OPHTHALMIC
PHOSPHOLINE IODIDE
WYETH PHARMS INC

ECONAZOLE NITRATE
CREAM; TOPICAL
SPECTAZOLE
ORTHO JANSSEN

Dec 23, 1982

EDETATE CALCIUM DISODIUM

TABLET; ORAL
CALCIUM DISODIUM VERSENATE
MEDICIS
500MG

EDETATE DISODIUM
INJECTABLE; INJECTION
DISODIUM EDETATE
WATSON LABS
EDETATE DISODIUM
WATSON LABS
SODIUM VERSENATE
3M

EDROPHONIUM CHLORIDE
INJECTABLE; INJECTION
EDROPHONIUM CHLORIDE
HOSPIRA
10MG/ML
WATSON LABS
10MG/ML
EDROPHONIUM CHLORIDE PRESERVATIVE FREE
WATSON LABS
10MG/ML
REVERSOL
ORGANON USA INC
10MG/ML

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DISCONTINUED DRUG PRODUCT LIST

6 - 123 (of 346)

EFAVIRENZ
CAPSULE; ORAL
SUSTIVA
BRISTOL MYERS SQUIBB
TABLET; ORAL
SUSTIVA
BRISTOL MYERS SQUIBB

100MG

N020972

002

Sep 17, 1998

300MG

N021360

001

Feb 01, 2002

200MG/ML

N019879

002

Nov 28, 1990

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

A075583
A075583
A075583
A075583
A075482
A075482
A075482
A075482
A075370
A075370
A075369
A075369
A075556
A075556
A075556
A075556
A075048
A075048
A075048
A075048

001
002
003
004
001
002
003
004
001
002
001
002
001
002
003
004
001
002
003
004

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug

N020668
N020668

002
001

Oct 28, 1998

Dec 27, 1996

A075736
A075736

001
002

Mar 25, 2003

Mar 25, 2003

1.25MG/ML
1.25MG/ML

A075456
A075571

001
001

Aug 22, 2000

Aug 22, 2000

1.25MG/ML

N019309

001

Feb 09, 1988

99.9%

A070803

001

Sep 08, 1987

EFLORNITHINE HYDROCHLORIDE
INJECTABLE; INJECTION
ORNIDYL
SANOFI AVENTIS US

ENALAPRIL MALEATE
TABLET; ORAL
ENALAPRIL MALEATE
APOTHECON

IVAX SUB TEVA PHARMS

KRKA DD NOVO MESTO

RANBAXY

SANDOZ

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

2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000

ENALAPRIL MALEATE; FELODIPINE

TABLET, EXTENDED RELEASE; ORAL
LEXXEL
ASTRAZENECA
5MG;2.5MG
5MG;5MG

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
IVAX SUB TEVA PHARMS 5MG;12.5MG
10MG;25MG

ENALAPRILAT
INJECTABLE; INJECTION
ENALAPRILAT
HOSPIRA
VASOTEC
BIOVAIL LABS INTL

ENFLURANE
LIQUID; INHALATION
ENFLURANE
ABBOTT

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6 - 124 (of 346)

ENOXACIN
TABLET; ORAL
PENETREX
SANOFI AVENTIS US

200MG
400MG

N019616
N019616

004
005

Dec 31, 1991

Dec 31, 1991

N020164

006

Jun 02, 2000

N016803

001

N016126

001

N007942
N007942

003
001

Feb 05, 1999

N019430

004

Aug 03, 1995

N019430

003

Aug 03, 1995

N016126

002

N010374

003

N017751
N017751
N021384

006
007
001

N014763

008

N017751

004

A084720
A084732

001
001

A080406
A080406
A080504
A080504
A089649
A089650

001
002
004
005
001
001

ENOXAPARIN SODIUM
INJECTABLE; SUBCUTANEOUS
LOVENOX (PRESERVATIVE FREE)
SANOFI AVENTIS US
90MG/0.6ML (150MG/ML)

EPINEPHRINE
AEROSOL, METERED; INHALATION
BRONKAID MIST
STERLING
0.25MG/INH
PRIMATENE MIST
WYETH CONS
0.2MG/INH
INJECTABLE; INJECTION
SUS-PHRINE SULFITE-FREE
FOREST LABS
1.5MG/AMP
5MG/ML
INJECTABLE; INTRAMUSCULAR
EPI E Z PEN JR
MERIDIAN MEDCL TECHN 0.15MG/DELIVERY
EPIPEN E Z PEN
MERIDIAN MEDCL TECHN 0.3MG/DELIVERY

EPINEPHRINE BITARTRATE
AEROSOL, METERED; INHALATION
BRONITIN MIST
WYETH CONS
0.3MG/INH
MEDIHALER-EPI
3M
0.3MG/INH

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION
DURANEST
ASTRAZENECA
DENTSPLY PHARM

0.005MG/ML;1%
0.005MG/ML;1.5%
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
ELKINS SINN
0.01MG/ML;1%
0.01MG/ML;2%
GRAHAM CHEM
0.01MG/ML;2%
0.02MG/ML;2%
HOSPIRA
0.005MG/ML;1%
0.005MG/ML;1.5%

Oct
Oct
Jun
Jun

19,
19,
21,
21,

1983
1983
1988
1988

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6 - 125 (of 346)

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE; INJECTION
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
ABBOTT
0.01MG/ML;1%
BEL MAR
0.01MG/ML;1%
0.01MG/ML;2%
DELL LABS
0.01MG/ML;1%
0.01MG/ML;2%
INTL MEDICATION
0.01MG/ML;1%
WATSON LABS
0.01MG/ML;1%
0.01MG/ML;1%
0.01MG/ML;2%
LIDOCATON
PHARMATON
0.01MG/ML;2%
0.02MG/ML;2%
XYLOCAINE W/ EPINEPHRINE
APP PHARMS
0.01MG/ML;2%
ASTRAZENECA
0.005MG/ML;1%
0.005MG/ML;1.5%
0.005MG/ML;2%
PATCH; IONTOPHORESIS, TOPICAL
LIDOSITE TOPICAL SYSTEM KIT
VYTERIS
1.05MG/PATCH;100MG/PATCH
SOLUTION; IONTOPHORESIS
IONTOCAINE
IOMED
0.01MG/ML;2%
SOLUTION; IONTOPHORESIS, TOPICAL
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
EMPI
0.01MG/ML;2%

A083154
A080820
A080757
A083389
A083390
A086402
A080377
A085463
A080377

001
001
001
001
001
001
003
001
004

A084729
A084728

001
001

N006488
N010418
N010418
N010418

003
006
010
008

N021504

001

May 06, 2004

N020530

001

Dec 21, 1995

N021486

001

Oct 26, 2004

A080758
A080759

001
001

N050807

002

Sep 15, 2006

100MG

N021437

003

Sep 27, 2002

EQ 300MG BASE

N020738

004

Dec 22, 1997

50,000 IU

A080884

001

50,000
50,000
50,000
50,000
50,000
50,000

A080747
A080956
A080951
A080825
A084053
A083102

001
001
001
001
001
001

Aug 17, 1983

Aug 17, 1983

EPINEPHRINE; PROCAINE HYDROCHLORIDE

INJECTABLE; INJECTION
PROCAINE HYDROCHLORIDE W/ EPINEPHRINE
BEL MAR
0.02MG/ML;1%
0.02MG/ML;2%

EPIRUBICIN HYDROCHLORIDE
INJECTABLE; IV (INFUSION)
EPIRUBICIN HYDROCHLORIDE
HOSPIRA
200MG/VIAL

EPLERENONE
TABLET; ORAL
INSPRA
GD SEARLE LLC

EPROSARTAN MESYLATE
TABLET; ORAL
TEVETEN
ABBOTT

ERGOCALCIFEROL
CAPSULE; ORAL
DELTALIN
LILLY
VITAMIN D
CHASE CHEM
EVERYLIFE
IMPAX LABS
LANNETT
VITARINE
WEST WARD

IU
IU
IU
IU
IU
IU

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6 - 126 (of 346)

ERGOLOID MESYLATES
CAPSULE; ORAL
HYDERGINE LC
NOVARTIS
SOLUTION; ORAL
HYDERGINE
NOVARTIS
TABLET; ORAL
ERGOLOID MESYLATES
MUTUAL PHARM
WATSON LABS

1MG

N018706

001

1MG/ML

N018418

001

1MG
1MG
1MG

A088891
A086433
A087244

001
001
001

Nov 01, 1985

May 27, 1982
Aug 16, 1982

1MG

A088207

001

Mar 22, 1984

0.5MG

N017993

003

0.5MG
1MG

A085153
A087417

001
001

0.5MG
1MG

A084868
A085809

001
001

1MG

A085020

002

0.5MG
0.5MG
1MG
1MG
0.5MG
1MG
0.5MG
1MG
0.5MG
1MG
0.5MG
1MG
0.5MG
1MG
1MG

A085899
A086265
A085900
A086264
A086984
A086985
A087407
A087552
A089233
A089234
A088013
A088014
A084930
A085177
A087183

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

0.5MG
1MG

A086189
A086188

001
001

0.5MG
1MG
HYDROGENATED ERGOT ALKALOIDS
IVAX PHARMS
0.5MG
1MG

N009087
N009087

002
001

A087186
A087185

001
001

N012102

001

A088337

001

Jun 08, 1984

A086750

001

Jul 29, 1982

GERIMAL
WATSON LABS
HYDERGINE
NOVARTIS
TABLET; SUBLINGUAL
ALKERGOT
SANDOZ
CIRCANOL
3M
DEAPRIL-ST
BRISTOL MYERS SQUIBB
ERGOLOID MESYLATES
KV PHARM

LEDERLE
MUTUAL PHARM
SUPERPHARM
VANGARD
WATSON LABS

GERIMAL
WATSON LABS
HYDERGINE
NOVARTIS

Jan 18, 1983

Sep
Sep
Sep
Sep

23,
23,
20,
20,

1986
1986
1982
1982

ERGOTAMINE TARTRATE
AEROSOL, METERED; INHALATION
MEDIHALER ERGOTAMINE
3M
0.36MG/INH
TABLET; SUBLINGUAL
ERGOSTAT
PARKE DAVIS
2MG
WIGRETTES
ORGANON USA INC
2MG

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6 - 127 (of 346)

ERYTHROMYCIN
CAPSULE, DELAYED REL PELLETS; ORAL
ERYC
PARKE DAVIS
250MG
250MG
ERYC 125
PARKE DAVIS
125MG
ERYC SPRINKLES
HOSPIRA
125MG
ERYTHROMYCIN
BARR
250MG
GEL; TOPICAL
EMGEL
ALTANA
2%
LOTION; TOPICAL
E-SOLVE 2
SYOSSET
2%
OINTMENT; OPHTHALMIC
ERYTHROMYCIN
PHARMADERM
5MG/GM
PHARMAFAIR
5MG/GM
ILOTYCIN
DISTA
0.5%
POWDER; FOR RX COMPOUNDING
ERYTHROMYCIN
PADDOCK LLC
100%
SOLUTION; TOPICAL
A/T/S
TARO PHARMS NORTH
2%
C-SOLVE-2
BIOGLAN PHARMA
2%
ERYDERM
ARBOR PHARMS INC
2%
ERYMAX
MERZ PHARMS
2%
ERYTHROMYCIN
ALPHARMA US PHARMS
1.5%
2%
2%
2%
2%
BAUSCH AND LOMB
2%
COREPHARMA
2%
LILLY
2%
PHARMAFAIR
1.5%
2%
SANSAC
DOW PHARM SCIENCES
2%
STATICIN
WESTWOOD SQUIBB
1.5%
T-STAT
WESTWOOD SQUIBB
2%
SWAB; TOPICAL
C-SOLVE-2
IVAX SUB TEVA PHARMS 2%
ERYCETTE
ORTHO JANSSEN
2%
ERYTHROMYCIN
COREPHARMA
2%
T-STAT
WESTWOOD SQUIBB
2%
TABLET, DELAYED RELEASE; ORAL
E-BASE
BARR
333MG

A062546
A062618

001
001

Jul 25, 1985

Sep 25, 1985

A062648

001

Oct 24, 1985

N050593

001

Jul 22, 1985

A063098

001

May 04, 1989

A063107

001

Aug 23, 1991

A062467

001

Jul 03, 1985

A062446
A062481

001
001

Sep 26, 1983

Apr 05, 1984

N050368

001

N050610

001

Nov 07, 1986

A062405

001

Nov 18, 1982

A062468

001

Jul 03, 1985

A062290

001

A062508

002

Jul 11, 1985

A062328
A062326
A062327
A062342
A062957
A064039
A064127
N050532
A062485
A062616

001
001
001
001
001
001
001
001
001
001

Apr
Apr
Apr
Feb
Jul
Jan
Feb

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

A063028

001

May 15, 1990

19,
19,
19,
25,
21,
27,
14,

1982
1982
1982
1982
1988
1994
1997

Jul 11, 1984

Jul 25, 1985

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DISCONTINUED DRUG PRODUCT LIST

6 - 128 (of 346)

ERYTHROMYCIN
TABLET, DELAYED RELEASE; ORAL
E-BASE
BARR
333MG
500MG
E-MYCIN
ARBOR PHARMS INC
250MG
333MG
ILOTYCIN
DISTA
250MG
ROBIMYCIN
ROBINS AH
250MG
R-P MYCIN
SOLVAY
250MG

A063086
A062999

001
001

A060272
A060272

001
002

A061910

001

A061633

001

A061659

001

BASE
BASE
BASE
BASE

A062162
A062162
A062237
A062087

001
002
001
001

EQ 125MG BASE
EQ 250MG BASE

A061897
A061897

001
002

EQ 125MG BASE/5ML

A061893

001

EQ
EQ
EQ
EQ
EQ

125MG
250MG
125MG
250MG
250MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A062353
A062409
A062169
A062169
A062362

001
001
001
002
001

EQ
EQ
EQ
EQ

125MG
125MG
250MG
250MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A061894
N050010
A061894
N050010

001
001
002
002

EQ 100MG BASE/ML

A061894

003

EQ 500MG BASE

A061896

001

EQ 125MG BASE
EQ 250MG BASE

A061895
A061895

001
002

N050599

001

A062055

001

A062305

001

May 15, 1990

Nov 25, 1988

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

EQ
EQ
EQ
EQ

125MG
250MG
250MG
250MG

Nov
Dec
Oct
Oct
Dec

18,
16,
17,
17,
17,

1982
1982
1990
1990
1982

ERYTHROMYCIN ESTOLATE; SULFISOXAZOLE ACETYL

SUSPENSION; ORAL
ILOSONE SULFA
LILLY

EQ 125MG BASE/5ML;EQ 600MG BASE/5ML

ERYTHROMYCIN ETHYLSUCCINATE
GRANULE; ORAL
ERYTHROMYCIN ETHYLSUCCINATE
BARR
EQ 200MG BASE/5ML
PEDIAMYCIN
ROSS LABS
EQ 200MG BASE/5ML

Sep 29, 1989

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6 - 129 (of 346)

ERYTHROMYCIN ETHYLSUCCINATE
SUSPENSION; ORAL
E-MYCIN E
PHARMACIA AND UPJOHN

EQ 200MG
EQ 400MG
ERYTHROMYCIN ETHYLSUCCINATE
ALPHARMA US PHARMS
EQ 200MG
EQ 400MG
DISTA
EQ 200MG
EQ 400MG
NASKA
EQ 400MG
PARKE DAVIS
EQ 200MG
EQ 400MG
PHARMAFAIR
EQ 200MG
EQ 400MG
WYAMYCIN E
WYETH AYERST
EQ 200MG
EQ 400MG
SUSPENSION/DROPS; ORAL
PEDIAMYCIN
ROSS LABS
EQ 100MG
TABLET; ORAL
E.E.S. 400

ARBOR PHARMS INC

EQ 400MG
ERYTHROMYCIN ETHYLSUCCINATE
BARR
EQ 400MG
MYLAN
EQ 400MG
TABLET, CHEWABLE; ORAL
E.E.S.
ARBOR PHARMS INC
EQ 200MG
ERYPED
ARBOR PHARMS INC
EQ 200MG
PEDIAMYCIN

ROSS LABS
EQ 200MG

BASE/5ML
BASE/5ML

A062198
A062198

001
002

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

A062200
A062200
A062177
A062177
A062674
A062231
A062231
A062559
A062558

001
002
001
002
001
001
002
001
001

BASE/5ML
BASE/5ML

A062123
A062123

002
001

BASE/2.5ML

A062305

002

BASE

A061905

001

BASE
BASE

A062256
A062847

001
001

BASE

N050297

002

BASE

N050297

003

BASE

A062306

001

EQ 200MG BASE/5ML;EQ 600MG BASE/5ML

A062758

001

EQ 200MG BASE/5ML;EQ 600MG BASE/5ML

N050529

001

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

N050370
N050370
N050370

001
002
003

EQ
EQ
EQ
EQ
EQ

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

A062586
A062586
N050182
N050182
N050609

001
002
002
003
002

Jan 04, 1988

Jan 04, 1988

EQ
EQ
ERYTHROMYCIN LACTOBIONATE
ABRAXIS PHARM
EQ
EQ

500MG BASE/VIAL
1GM BASE/VIAL

A062563
A062563

001
002

Mar 28, 1985

Mar 28, 1985

500MG BASE/VIAL
1GM BASE/VIAL

A062604
A062604

001
002

Nov 24, 1986

Nov 24, 1986

Mar 10, 1987

Mar 15, 1985

Mar 15, 1985

Sep 14, 1988

Jul 05, 1988

ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL

GRANULE; ORAL
ERYZOLE
ALRA
PEDIAZOLE
ROSS LABS

Jun 15, 1988

ERYTHROMYCIN GLUCEPTATE
INJECTABLE; INJECTION
ILOTYCIN GLUCEPTATE
DISTA

ERYTHROMYCIN LACTOBIONATE
INJECTABLE; INJECTION
ERYTHROCIN
ABBOTT
HOSPIRA

ERYTHROMYCIN
ELKINS SINN

Sep 24, 1986

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6 - 130 (of 346)

ERYTHROMYCIN LACTOBIONATE
INJECTABLE; INJECTION
ERYTHROMYCIN LACTOBIONATE
BAXTER HLTHCARE
EQ
EQ
TEVA PARENTERAL
EQ
EQ

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

A062993
A062993
A063253
A063253

001
002
001
002

May
May
Jul
Jul

09,
09,
30,
30,

1989
1989
1993
1993

EQ 250MG BASE
EQ 250MG BASE

A061304
A061887

001
001

EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE

A062032
A062032
A062322

001
002
001

EQ 125MG BASE
EQ 500MG BASE

A060359
A060359

002
003

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A061591
A063179
A061461
A061461
A062089
A062089
A061505
A061505
A061743
A062121
A062121

001
001
001
002
001
002
001
002
001
002
001

EQ 250MG BASE

A061605

001

EQ 500MG BASE

A061605

002

EQ 250MG BASE
EQ 500MG BASE

A061791
A061791

001
002

EQ 250MG BASE
EQ 500MG BASE

A061675
A061675

001
002

EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE

A077660
A077660
A077660

001
002
003

Jul 31, 2007

Jul 31, 2007
Jul 31, 2007

10MG/ML
20MG/ML

N019386
N019386

003
007

Aug 15, 1988

May 28, 2003

1MG
2MG

N019080
N019080

001
002

Dec 26, 1990

Dec 26, 1990

ERYTHROMYCIN STEARATE
TABLET; ORAL
BRISTAMYCIN
BRISTOL
ERYPAR
PARKE DAVIS
WARNER CHILCOTT
ERYTHROCIN STEARATE
ARBOR PHARMS INC
ERYTHROMYCIN STEARATE
BARR
IVAX SUB TEVA PHARMS
LEDERLE
MYLAN
PUREPAC PHARM
WATSON LABS
ETHRIL 250
BRISTOL MYERS SQUIBB
ETHRIL 500
BRISTOL MYERS SQUIBB
PFIZER-E
PFIZER
WYAMYCIN S
WYETH AYERST

250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG

May 15, 1990

ESCITALOPRAM OXALATE
CAPSULE; ORAL
ESCITALOPRAM OXALATE
MYLAN PHARMS INC

ESMOLOL HYDROCHLORIDE
INJECTABLE; INJECTION
BREVIBLOC
BAXTER HLTHCARE CORP

ESTAZOLAM
TABLET; ORAL
PROSOM
ABBOTT

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6 - 131 (of 346)

ESTRADIOL
FILM, EXTENDED RELEASE; TRANSDERMAL
ESCLIM
WOMEN FIRST HLTHCARE 0.025MG/24HR
0.0375MG/24HR
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
ESTRADIOL
ORTHO MCNEIL PHARM
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
FEMPATCH
PARKE DAVIS
0.025MG/24HR
VIVELLE
NOVARTIS
0.025MG/24HR
0.0375MG/24HR
0.075MG/24HR
GEL; TOPICAL
ESTROGEL
ASCEND
0.06%
TABLET; ORAL
ESTRACE
BRISTOL MYERS SQUIBB 0.5MG
ESTRADIOL
AAI PHARMA INC
0.5MG
1MG
2MG
HERITAGE PHARMS INC
0.5MG
1MG
2MG
GYNODIOL
DURAMED PHARMS BARR
0.5MG
1MG
1.5MG
2MG
INNOFEM
NOVO NORDISK INC
0.5MG
1MG
2MG
TABLET; VAGINAL
VAGIFEM
NOVO NORDISK INC
25MCG

N020847
N020847
N020847
N020847
N020847

001
002
003
004
005

Aug
Aug
Aug
Aug
Aug

04,
04,
04,
04,
04,

1998
1998
1998
1998
1998

N021048
N021048
N021048

001
002
003

Sep 20, 1999

Sep 20, 1999
Sep 20, 1999

N020417

001

Dec 03, 1996

N020323
N020323
N020323

005
001
003

Aug 16, 2000

Oct 28, 1994
Oct 28, 1994

N021166

001

Feb 09, 2004

A081295

001

Jun 30, 1993

A040138
A040138
A040138
A040275
A040275
A040275

001
002
003
001
002
003

Jan
Jan
Jan
Dec
Dec
Dec

30,
30,
30,
29,
29,
29,

1998
1998
1998
1998
1998
1998

A040212
A040212
A040212
A040212

001
002
003
004

Dec
Dec
Dec
Dec

29,
29,
29,
29,

1997
1997
1997
1997

A040312
A040312
A040312

001
002
003

Nov 19, 1999

Nov 19, 1999
Nov 19, 1999

N020908

001

Mar 26, 1999

A085470
A085470

001
002

N020874

001

N017968

001

A085603

001

ESTRADIOL CYPIONATE
INJECTABLE; INJECTION
DEPO-ESTRADIOL
PHARMACIA AND UPJOHN

1MG/ML
3MG/ML

ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE

INJECTABLE; INTRAMUSCULAR
LUNELLE
PHARMACIA AND UPJOHN 5MG/0.5ML;25MG/0.5ML

Oct 05, 2000

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

Mar 13, 1986

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6 - 132 (of 346)

ESTRADIOL VALERATE
INJECTABLE; INJECTION
ESTRADIOL VALERATE
WATSON LABS

10MG/ML

A083546

001

A086423

001

A085865
A085860

001
001

N004782

002

N020303

002

Dec 30, 1994

N020303

001

Dec 30, 1994

0.45MG;200MG

N011045

002

0.45MG;400MG

N011045

001

0.45MG;200MG

N010971

005

0.45MG;400MG

N010971

003

0.3MG
0.625MG
1.25MG
2.5MG

A083266
A083266
A083266
A083266

001
002
003
004

0.625MG
1.25MG
2.5MG
1.25MG

A083414
A083765
A085907
A085302

001
001
001
001

0.3MG
0.625MG
1.25MG
2.5MG

A086715
A083209
A083856
A083857

001
001
001
001

0.625MG
1.25MG

A084215
A083376

001
002

0.625MG
1.25MG
2.5MG

A085076
A085008
A085007

001
001
001

ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE

INJECTABLE; INJECTION
DITATE-DS
SAVAGE LABS
8MG/ML;180MG/ML
TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE
WATSON LABS
4MG/ML;90MG/ML
8MG/ML;180MG/ML

ESTROGENS, CONJUGATED
TABLET; ORAL
PREMARIN
WYETH PHARMS INC

2.5MG

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

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

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ESTRONE
INJECTABLE; INJECTION
ESTROGENIC SUBSTANCE
WYETH AYERST
2MG/ML
ESTRONE
WATSON LABS
2MG/ML
NATURAL ESTROGENIC SUBSTANCE-ESTRONE
WATSON LABS
2MG/ML
THEELIN
PARKEDALE
1MG/ML
2MG/ML
5MG/ML

A083488

001

A083397

001

A085237

001

N003977
N003977
N003977

001
002
003

1.5MG/GM

A084710

001

0.75MG
1.5MG
3MG
3MG

A040296
A040296
A040296
A040359

001
002
003
003

Nov
Nov
Nov
Aug

01,
01,
01,
26,

1999
1999
1999
1999

1MG
2MG
3MG
1MG
2MG
3MG
1MG
2MG
3MG

A091124
A091124
A091124
A091169
A091169
A091169
A091165
A091165
A091165

001
002
003
001
002
003
001
002
003

Sep
Sep
Sep
May
May
May
Jul
Jul
Jul

13,
13,
13,
23,
23,
23,
14,
14,
14,

2011
2011
2011
2011
2011
2011
2011
2011
2011

50MG

N016092

002

200MG
500MG

N016320
N016320

002
004

100MG
200MG
500MG
750MG

A084463
A084463
A084463
A084463

001
002
003
004

100MG
200MG
500MG
750MG

N010021
N010021
N010021
N010021

004
007
002
010

Nov 23, 1982

ESTROPIPATE
CREAM; VAGINAL
OGEN
PHARMACIA AND UPJOHN
TABLET; ORAL
ESTROPIPATE
DURAMED PHARMS BARR

MYLAN

ESZOPICLONE
TABLET; ORAL
ESZOPICLONE
LUPIN LTD

TEVA

WOCKHARDT LTD

ETHACRYNIC ACID
TABLET; ORAL
EDECRIN
ATON

ETHAMBUTOL HYDROCHLORIDE
TABLET; ORAL
MYAMBUTOL
STI PHARMA LLC

ETHCHLORVYNOL
CAPSULE; ORAL
ETHCHLORVYNOL
BANNER PHARMACAPS

PLACIDYL
ABBOTT

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ETHINAMATE
CAPSULE; ORAL

VALMID

DISTA

500MG

N009750

001

0.02MG
0.05MG
0.5MG

N005292
N005292
N005292

001
002
003

0.05MG

N016649

001

0.01MG
0.05MG

N005490
N005490

003
002

0.035MG;1MG

N018168

001

0.05MG;1MG

N016927

001

0.035MG;1MG

A072720

001

Dec 30, 1991

0.05MG;1MG

A072722

001

Dec 30, 1991

0.035MG;1MG

N018160

001

0.05MG;1MG

N016936

001

N018926

001

0.05MG;75MG;1MG

N016766

001

0.05MG;75MG;2.5MG

N016854

001

N020946

001

Sep 01, 1998

N020683

001

Mar 27, 1997

A075796

002

Apr 30, 2001

A075809

001

Jul 16, 2001

A075803

001

Mar 20, 2002

N020860

001

Jul 13, 1998

A075862

001

Apr 29, 2003

ETHINYL ESTRADIOL
TABLET; ORAL
ESTINYL
SCHERING

FEMINONE
PHARMACIA AND UPJOHN
LYNORAL
ORGANON USA INC

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

TABLET; ORAL-21
DEMULEN 1/35-21
GD SEARLE LLC
DEMULEN 1/50-21
GD SEARLE LLC
ZOVIA 1/35E-21
WATSON LABS
ZOVIA 1/50E-21
WATSON LABS
TABLET; ORAL-28
DEMULEN 1/35-28
GD SEARLE LLC
DEMULEN 1/50-28
GD SEARLE LLC

ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE

TABLET; ORAL-28
NORQUEST FE
GD SEARLE LLC

0.035MG;75MG;1MG

Jul 18, 1986

ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE ACETATE

TABLET; ORAL-28

NORLESTRIN FE 1/50

PARKE DAVIS
NORLESTRIN FE 2.5/50

PARKE DAVIS

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET; ORAL
PREVEN EMERGENCY CONTRACEPTIVE KIT
DURAMED
0.05MG;0.25MG
TABLET; ORAL-21
ALESSE
WYETH PHARMS
0.02MG;0.1MG
AVIANE-21
DURAMED PHARMS BARR
0.02MG;0.1MG
ENPRESSE-21
DURAMED PHARMS BARR
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1
25MG
LESSINA-21
BARR
0.02MG;0.1MG
LEVLITE
BAYER HLTHCARE
0.02MG;0.1MG
LEVONORGESTREL AND ETHINYL ESTRADIOL
BARR
0.02MG;0.1MG

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ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET; ORAL-21
LEVORA 0.15/30-21
WATSON LABS
NORDETTE-21
DURAMED RES
PORTIA-21
BARR
TRIPHASIL-21
WYETH PHARMS
TRIVORA-21
WATSON LABS

0.03MG;0.15MG

A073592

001

Dec 13, 1993

0.03MG;0.15MG

N018668

001

May 10, 1982

0.03MG;0.15MG

A075866

001

May 23, 2002

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 N019192
25MG

001

Nov 01, 1984

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A074538
25MG

001

Dec 18, 1997

N020683

002

Mar 27, 1997

N020860

002

Jul 13, 1998

A075862

002

Apr 29, 2003

N019190

001

Nov 01, 1984

A076198

001

Apr 22, 2004

N017566

001

A072694

001

N017488

001

A071541

001

Dec 14, 1987

A071545

001

Feb 09, 1989

A070684

001

Jan 29, 1987

A072692

001

Feb 28, 1992

N017489

002

N018354

001

Jan 11, 1982

N019004

001

Apr 04, 1984

N018985

001

Apr 04, 1984

N018127

001

N018128

001

N018977

001

Apr 13, 1984

A072697

001

Feb 28, 1992

A071542

001

Dec 14, 1987

TABLET; ORAL-28
ALESSE
WYETH PHARMS
0.02MG;0.1MG
LEVLITE
BAYER HLTHCARE
0.02MG;0.1MG
LEVONORGESTREL AND ETHINYL ESTRADIOL
BARR
0.02MG;0.1MG
TRIPHASIL-28
WYETH PHARMS INC
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1
25MG

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET; ORAL-21
BALZIVA-21
BARR
0.035MG;0.4MG
BREVICON 21-DAY
WATSON LABS
0.035MG;0.5MG
GENCEPT 10/11-21
BARR
0.035MG,0.035MG;0.5MG,1MG
MODICON 21
ORTHO MCNEIL PHARM
0.035MG;0.5MG
N.E.E. 1/35 21
LPI
0.035MG;1MG
NORCEPT-E 1/35 21
ORTHO MCNEIL PHARM
0.035MG;1MG
NORETHINDRONE AND ETHINYL ESTRADIOL
WATSON LABS
0.035MG;0.5MG
NORTREL 0.5/35-21
BARR
0.035MG;0.5MG
ORTHO-NOVUM 1/35-21
ORTHO MCNEIL PHARM
0.035MG;1MG
ORTHO-NOVUM 10/11-21
ORTHO MCNEIL JANSSEN 0.035MG,0.035MG;0.5MG,1MG
ORTHO-NOVUM 7/14-21
ORTHO MCNEIL PHARM
0.035MG,0.035MG;0.5MG,1MG
ORTHO-NOVUM 7/7/7-21
JANSSEN PHARMS
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
G
OVCON-35
WARNER CHILCOTT
0.035MG;0.4MG
OVCON-50
WARNER CHILCOTT
0.05MG;1MG
TRI-NORINYL 21-DAY

WATSON LABS
0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
TABLET; ORAL-28
GENCEPT 10/11-28
BARR
0.035MG,0.035MG;0.5MG,1MG
N.E.E. 1/35 28
LPI
0.035MG;1MG

Feb 28, 1992

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ETHINYL ESTRADIOL; NORETHINDRONE

TABLET; ORAL-28
NORCEPT-E 1/35 28
ORTHO MCNEIL PHARM
ORTHO-NOVUM 10/11-28
ORTHO MCNEIL JANSSEN
ORTHO-NOVUM 7/14-28
ORTHO MCNEIL PHARM

0.035MG;1MG

A071546

001

Feb 09, 1989

0.035MG,0.035MG;0.5MG,1MG

N018354

002

Jan 11, 1982

0.035MG,0.035MG;0.5MG,1MG

N019004

002

Apr 04, 1984

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

N020130

001

Oct 09, 1996

0.05MG;1MG

N016749

001

0.05MG;2.5MG

N016852

001

0.05MG;1MG

N016723

001

N019653

001

Dec 29, 1989

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, N019697
0.25MG

002

Jul 03, 1992

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

TABLET; ORAL-21
ESTROSTEP 21
WARNER CHILCOTT
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

0.035MG;0.25MG

ETHINYL ESTRADIOL; NORGESTREL

TABLET; ORAL-21
LO/OVRAL
WYETH PHARMS INC
OGESTREL 0.5/50-21
WATSON LABS
OVRAL
WYETH PHARMS
TABLET; ORAL-28
OVRAL-28
WYETH PHARMS

0.03MG;0.3MG

N017612

001

0.05MG;0.5MG

A075406

001

0.05MG;0.5MG

N016672

001

0.05MG;0.5MG

N016806

001

99%

N009190

001

10MG
50MG
100MG

N009078
N009078
N009078

003

006

008

500MG

N010841

003

62.5MG
125MG

N011047
N011047

002

001

ETHIODIZED OIL
OIL; INTRALYMPHATIC

ETHIODOL

GUERBET

ETHOPROPAZINE HYDROCHLORIDE
TABLET; ORAL

PARSIDOL

PARKE DAVIS

ETHOTOIN
TABLET; ORAL

PEGANONE

LUNDBECK INC

ETHOXZOLAMIDE
TABLET; ORAL

CARDRASE

PHARMACIA AND UPJOHN

Dec 15, 1999

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6 - 137 (of 346)

ETHOXZOLAMIDE
TABLET; ORAL
ETHAMIDE
ALLERGAN

125MG

N016144

001

2MG/5ML

N014006

002

2MG

N014005

002

1MG;0.1MG

N016029

002

1MG;0.1MG

N016029

003

1MG;0.1MG

N016705

001

0.5%
1%

N017751
N017751

003
005

50MG/ML

N019545

001

Apr 20, 1987

300MG
200MG
300MG
200MG
300MG
200MG
200MG
300MG
300MG
200MG
200MG
300MG
300MG
200MG
200MG
300MG

A074929
A074842
A074842
A074899
A074899
A074932
A075071
A074932
A075071
A074840
A074942
A074840
A074942
A075126
A074844
A074844

001
001
002
001
002
001
001
002
002
001
001
002
002
001
001
002

Jan
Jul
Jul
Jul
Jul
May
Sep
May
Sep
Aug
Sep
Aug
Sep
Sep
Dec
Dec

200MG
300MG

N018922
N018922

002
003

Jan 31, 1991

Jan 31, 1991

400MG
400MG
500MG
400MG

A074927
A074819
A074819
A074841

001
001
002
001

Oct
Feb
Apr
Jun

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
ENDO PHARMS
IVAX SUB TEVA PHARMS
MYLAN

SANDOZ

TEVA
WATSON LABS
LODINE
WYETH PHARMS INC
TABLET; ORAL
ETODOLAC
AAIPHARMA LLC
ACTAVIS ELIZABETH
ENDO PHARMS

30,
17,
17,
08,
08,
16,
30,
16,
30,
29,
30,
29,
30,
16,
23,
23,

30,
28,
28,
27,

1998
1997
1997
1997
1997
1997
1998
1997
1998
1997
1997
1997
1997
1999
1997
1997

1997
1997
1998
1997

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 138 (of 346)

ETODOLAC
TABLET; ORAL
ETODOLAC
IVAX SUB TEVA PHARMS

400MG
500MG
400MG
500MG
400MG
500MG
400MG
400MG
400MG
500MG
400MG
400MG
500MG

A074883
A074883
A075012
A075012
A075226
A075226
A074839
A074846
A074847
A074847
A074892
A075069
A074892

001
002
001
002
001
002
001
001
001
002
001
001
002

Feb
Nov
Sep
Sep
Nov
Nov
Jul
Feb
Apr
Apr
Apr
Apr
Oct

400MG
500MG
TABLET, EXTENDED RELEASE; ORAL
ETODOLAC
POINT HOLDINGS
400MG
SANDOZ
400MG
500MG
600MG
WATSON LABS FLORIDA
400MG
500MG
LODINE XL
WYETH PHARMS INC
400MG
500MG
600MG

N018922
N018922

004
005

Jul 29, 1993

Jun 28, 1996

A075696
A075943
A075943
A075943
A075829
A075829

001
001
002
003
001
002

Jul
Jul
Jul
Jul
Nov
Nov

N020584
N020584
N020584

001
003
002

Oct 25, 1996

Jan 20, 1998
Oct 25, 1996

50MG
100MG

N019557
N019557

001
002

Dec 30, 1986

Dec 30, 1986

20MG/ML
20MG/ML
20MG/ML
20MG/ML
20MG/ML
20MG/ML

A074320
A074351
A074968
A074813
A074510
A074228

001
001
001
001
001
001

Aug
Aug
Jan
Jul
Jun
Oct

20MG/ML

A074166

001

Feb 27, 1995

20MG/ML

N018768

001

Nov 10, 1983

N020906
N020906

001
002

Feb 27, 1998

Feb 27, 1998

N019369
N019369

001
002

Sep 30, 1986

Sep 30, 1986

MYLAN
RANBAXY
SANDOZ
TEVA
WATSON LABS

LODINE
WYETH PHARMS INC

28,
20,
30,
30,
24,
24,
11,
28,
23,
23,
16,
16,
29,

31,
26,
26,
26,
30,
30,

1997
1998
1998
1998
1998
1998
1997
1997
1999
1999
1997
1998
1998

2000
2002
2002
2002
2001
2001

ETOPOSIDE
CAPSULE; ORAL
VEPESID
BRISTOL MYERS SQUIBB
INJECTABLE; INJECTION
ETOPOSIDE
HOSPIRA
MARSAM PHARMS LLC
PIERRE FABRE
TEVA PARENTERAL
WATSON LABS
TOPOSAR
TEVA PARENTERAL
VEPESID
BRISTOL MYERS SQUIBB

30,
30,
09,
09,
29,
15,

1995
1995
1998
1997
1995
1996

ETOPOSIDE PHOSPHATE
INJECTABLE; INJECTION
ETOPOPHOS PRESERVATIVE FREE
BRISTOL MYERS SQUIBB EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL

ETRETINATE
CAPSULE; ORAL
TEGISON
ROCHE

10MG
25MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 139 (of 346)

EVANS BLUE
INJECTABLE; INJECTION
EVANS BLUE
PARKE DAVIS

0.5%

N008041

001

A075942
A075707
A075705
A075870
A075905

001
001
001
001
001

Aug
Apr
Apr
Nov
Nov

A075708
A075669

001
001

Apr 16, 2001

Apr 16, 2001

A075729

001

Dec 17, 2001

N019510

001

Nov 04, 1986

N019510

004

Nov 04, 1986

N020249

001

Feb 18, 1994

A075650
A075650
A075610
A075639
A075639
A075302
A075793
A075302
A075793

001
002
001
002
001
001
001
002
002

Sep
Sep
Mar
Dec
Dec
Apr
Apr
Apr
Apr

N020801

001

Sep 24, 1998

N021712
N021712

001
002

Sep 24, 2004

Sep 24, 2004

N020752
N020752

001
002

May 28, 1998

May 28, 1998

87MG

N021695

002

Nov 30, 2004

100MG

N019304

001

Dec 31, 1993

100MG

N021612

002

Jan 11, 2006

67MG
134MG
200MG

N019304
N019304
N019304

002
003
004

Feb 09, 1998

Jun 30, 1999
Jun 30, 1999

107MG

A076520

002

Dec 29, 2005

54MG
160MG

N021203
N021203

001
003

Sep 04, 2001

Sep 04, 2001

FAMOTIDINE
INJECTABLE; INJECTION
FAMOTIDINE
APOTEX INC
APOTHECON
HOSPIRA

10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
FAMOTIDINE PRESERVATIVE FREE
APOTHECON
10MG/ML
HOSPIRA
10MG/ML
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
ABBOTT
0.4MG/ML
PEPCID
MERCK
10MG/ML
PEPCID PRESERVATIVE FREE
MERCK
10MG/ML
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER
MERCK
0.4MG/ML
TABLET; ORAL
FAMOTIDINE
ACTAVIS ELIZABETH
20MG
40MG
APOTEX
10MG
MUTUAL PHARM
20MG
40MG
SANDOZ
20MG
20MG
40MG
40MG
TABLET, CHEWABLE; ORAL
PEPCID AC
MERCK SHARP DOHME
10MG
TABLET, ORALLY DISINTEGRATING; ORAL
FLUXID
SCHWARZ PHARMA
20MG
40MG
PEPCID RPD
MERCK
20MG
40MG

02,
16,
16,
23,
23,

14,
14,
12,
12,
12,
16,
16,
16,
16,

2002
2001
2001
2001
2001

2001
2001
2002
2001
2001
2001
2001
2001
2001

FENOFIBRATE
CAPSULE; ORAL
ANTARA (MICRONIZED)
LUPIN ATLANTIS
LIPIDIL
ABBOTT
LIPOFEN
CIPHER PHARMS INC
TRICOR (MICRONIZED)
ABBOTT

TABLET; ORAL
FENOFIBRATE
MYLAN
TRICOR
ABBOTT

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 140 (of 346)

FENOLDOPAM MESYLATE
INJECTABLE; INJECTION
FENOLDOPAM MESYLATE
LUITPOLD
TEVA PARENTERAL

EQ 10MG BASE/ML
EQ 10MG BASE/ML

A076656
A077826

001
001

Dec 01, 2003

Mar 07, 2007

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A072307
A072308
A072355
A072356
A072437
A072438
A072214
A071738
A072394
A072395
A072946
A072472
A072294
A072981
A072293
A072982

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Oct
Oct
Apr
Apr
Aug
Aug
Aug
Aug

22,
22,
17,
17,
22,
22,
17,
17,
17,
17,
30,
30,
17,
19,
17,
19,

1988
1988
1988
1988
1988
1988
1988
1988
1988
1988
1991
1991
1988
1991
1988
1991

EQ 300MG BASE

N017604

002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A072274
A072309
A072326
A072357
A072902
A072429
A072194
A072396
A072362
A072165
A072407
A072602

001
001
001
001
001
001
001
001
001
001
001
001

May
Aug
Aug
Aug
Dec
Aug
Aug
Oct
Aug
Aug
Aug
Oct

02,
17,
17,
17,
21,
17,
17,
17,
17,
17,
17,
11,

1988
1988
1988
1988
1990
1988
1988
1988
1988
1988
1988
1988

EQ 600MG BASE

N017710

001

A070636
A070637
A073488

001
001
001

Apr 30, 1990

Apr 30, 1990
Jun 30, 1992

A074917

001

Feb 03, 1998

N021947

006

Mar 02, 2007

N020195
N020195
N020195
N020195

007
001
002
003

Oct
Oct
Oct
Oct

FENOPROFEN CALCIUM
CAPSULE; ORAL
FENOPROFEN CALCIUM
AM THERAP
HALSEY
PAR PHARM
QUANTUM PHARMICS
SANDOZ
WARNER CHILCOTT
WATSON LABS

NALFON
PEDINOL
TABLET; ORAL
FENOPROFEN CALCIUM
ACTAVIS ELIZABETH
AM THERAP
CLONMEL HLTHCARE
HALSEY
MUTUAL PHARM
PAR PHARM
QUANTUM PHARMICS
SANDOZ
USL PHARMA
WATSON LABS

NALFON
DISTA

200MG
300MG
200MG
300MG
200MG
300MG
200MG
300MG
200MG
300MG
200MG
300MG
200MG
200MG
300MG
300MG

600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG
600MG

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
EQ 0.05MG BASE/ML
TABLET; BUCCAL
FENTORA
CEPHALON
EQ 0.3MG BASE
TROCHE/LOZENGE; ORAL
FENTANYL
CEPHALON
EQ 0.1MG BASE
EQ 0.2MG BASE
EQ 0.3MG BASE
EQ 0.4MG BASE

30,
04,
04,
04,

1995
1993
1993
1993

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 141 (of 346)

FENTANYL HYDROCHLORIDE
SYSTEM; IONTOPHORESIS, TRANSDERMAL
IONSYS
INCLINE THERAP
10.8MCG

N021338

001

May 22, 2006

600MG/PACKET

N020292

001

Oct 14, 1997

25uCi/ML

N016729

001

N006012

003

N020625

001

Jul 25, 1996

A076169

001

Jul 13, 2005

N017879

001

N017787

001

5MG

A076340

001

100MG

N016769

001

50MG
100MG
150MG

A076030
A076030
A076030

001
002
003

Oct 28, 2002

Oct 28, 2002
Oct 28, 2002

200MG

N018830

002

Oct 31, 1985

500MG/VIAL

N016929

001

A076889
A076889

001
002

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

182MG;0.33MG

FEXOFENADINE HYDROCHLORIDE
CAPSULE; ORAL
ALLEGRA
SANOFI AVENTIS US
60MG
FEXOFENADINE HYDROCHLORIDE
BARR
60MG

FIBRINOGEN, I-125
INJECTABLE; INJECTION
IBRIN
GE HEALTHCARE
154uCi/VIAL
RADIONUCLIDE-LABELED (125 I) FIBRINOGEN (HUMAN) SENSOR
ABBOTT
140uCi/ML

FINASTERIDE
TABLET; ORAL
FINASTERIDE
IVAX SUB TEVA PHARMS

Jun 19, 2006

FLAVOXATE HYDROCHLORIDE
TABLET; ORAL
URISPAS
ORTHO MCNEIL JANSSEN

FLECAINIDE ACETATE
TABLET; ORAL
FLECAINIDE ACETATE
SANDOZ

TAMBOCOR
MEDICIS

FLOXURIDINE
INJECTABLE; INJECTION
FUDR
HOSPIRA

FLUCONAZOLE
INJECTABLE; INJECTION

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

APOTEX INC
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)

Mar 25, 2005

Mar 25, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 142 (of 346)

FLUCONAZOLE
INJECTABLE; INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA
200MG/100ML (2MG/ML)
400MG/200ML (2MG/ML)
TABLET; ORAL
FLUCONAZOLE
GEDEON RICHTER USA
50MG
100MG
150MG
200MG
ROXANE
50MG
100MG
150MG
200MG
SANDOZ
50MG
100MG
150MG
200MG

A076617
A076617

001
002

Jul 29, 2004

Jul 29, 2004

A076432
A076432
A076432
A076432
A076213
A076213
A076213
A076213
A076086
A076086
A076086
A076086

001
002
003
004
001
002
003
004
001
002
003
004

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

4-40mCi/ML
4-90mCi/ML

N020306
N020306

001
002

Aug 19, 1994

Sep 25, 2001

0.1MG

N010060

001

0.03%

N016379

001

0.025MG/SPRAY

N018148

001

0.029MG/SPRAY

N020409

001

Mar 08, 1995

0.025%

A088360

001

Jan 16, 1984

0.01%
0.01%
0.025%
0.01%
0.025%
0.01%
0.025%
0.01%
0.01%
0.025%
0.01%
0.025%

A088361
A086810
A086811
A088047
A088045
A088499
A088506
A040035
A087102
A040042
A088757
A088756

001
001
001
001
001
001
001
001
001
001
001
001

Jan
Mar
Mar
Dec
Dec
Aug
Aug
Oct
Apr
Oct
Feb
Mar

0.025%

A087156

002

Sep 06, 1984

29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,
29,

2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004
2004

FLUDEOXYGLUCOSE F-18
INJECTABLE; INJECTION
FLUDEOXYGLUCOSE F 18
DOWNSTATE CLINCL

FLUDROCORTISONE ACETATE
TABLET; ORAL
FLORINEF
KING PHARMS

FLUMETHASONE PIVALATE
CREAM; TOPICAL
LOCORTEN
NOVARTIS

FLUNISOLIDE
SPRAY, METERED; NASAL
NASALIDE
IVAX RES
NASAREL
TEVA BRANDED PHARM

FLUOCINOLONE ACETONIDE
CREAM; TOPICAL
FLUOCET
ALPHARMA US PHARMS
FLUOCINOLONE ACETONIDE
ALPHARMA US PHARMS
PERRIGO NEW YORK
PHARMADERM
PHARMAFAIR
TARO

USL PHARMA
FLUONID
ALLERGAN HERBERT

16,
04,
04,
16,
16,
02,
02,
31,
27,
31,
11,
28,

1984
1982
1982
1982
1982
1984
1984
1994
1982
1994
1985
1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 143 (of 346)

FLUOCINOLONE ACETONIDE
CREAM; TOPICAL
FLUOTREX
SAVAGE LABS
SYNALAR-HP
MEDIMETRIKS PHARMS
GEL; TOPICAL
FLUONID
ALLERGAN HERBERT
OINTMENT; TOPICAL
FLUOCINOLONE ACETONIDE
PHARMADERM
PHARMAFAIR
USL PHARMA
FLUONID
ALLERGAN HERBERT
FLUOTREX
SAVAGE LABS
SOLUTION; TOPICAL
FLUOCINOLONE ACETONIDE
ALPHARMA US PHARMS
BAUSCH AND LOMB
MORTON GROVE
PHARMADERM
PHARMAFAIR
FLUONID
ALLERGAN HERBERT
FLUOTREX
SAVAGE LABS

0.01%
0.025%

A088174
A088173

001
001

May 06, 1983

Mar 09, 1983

0.2%

N016161

002

0.025%

A087300

001

May 27, 1982

0.025%
0.025%
0.025%

A088046
A088507
A088742

001
001
001

Dec 16, 1982

Feb 27, 1984
Feb 08, 1985

0.025%

A087157

001

Sep 06, 1984

0.025%

A088172

001

Mar 09, 1983

0.01%
0.01%
0.01%
0.01%
0.01%

A087159
A040059
A088312
A088048
A088449

001
001
001
001
001

Jun
Dec
Jan
Dec
Feb

0.01%

A087158

001

Mar 17, 1983

0.01%

A088171

001

Mar 09, 1983

0.025%;EQ 3.5MG BASE/GM

A060700

001

0.05%
0.05%
BASE
0.05%

A071790
A071500

001
001

Jul 13, 1988

Jun 10, 1987

A074204

001

Jun 13, 1995

0.05%
0.05%

A072857
A072522

001
001

Aug 02, 1989

Sep 28, 1990

25%

N017869

001

EQ 500MG BASE/2ML (EQ 250MG BASE/ML)

N022186

002

N011748

001

A070185

001

16,
20,
27,
16,
08,

1982
1993
1984
1982
1984

FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE

CREAM; TOPICAL
NEO-SYNALAR
MEDIMETRIKS PHARMS

FLUOCINONIDE
CREAM; TOPICAL
FLUOCINONIDE
PERRIGO NEW YORK
TARO
FLUOCINONIDE EMULSIFIED
ACTAVIS MID ATLANTIC
SOLUTION; TOPICAL
FLUOCINONIDE
TARO
TEVA PHARMS

FLUORESCEIN SODIUM
INJECTABLE; INJECTION
FUNDUSCEIN-25
NOVARTIS
INJECTABLE; INTRAVENOUS
AK-FLUOR 25%
AKORN

Aug 08, 2008

FLUOROMETHOLONE
CREAM; TOPICAL
OXYLONE
PHARMACIA AND UPJOHN 0.025%
SUSPENSION/DROPS; OPHTHALMIC
FLUOR-OP
NOVARTIS
0.1%

Feb 27, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 144 (of 346)

FLUOROMETHOLONE ACETATE; TOBRAMYCIN

SUSPENSION/DROPS; OPHTHALMIC
TOBRASONE
ALCON
0.1%;0.3%

N050628

001

Jul 21, 1989

N019525

001

Sep 29, 1989

50MG/ML
50MG/ML
50MG/ML
50MG/ML

A081222
N017959
A040023
A081225

001
001
001
001

Jun 28, 1991

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)
50MG/ML

A088929
A089152
A089428
A089519
A040291
A040379
A089508
A087791
A088766
A088767
A089434
N012209
A087792

001
001
001
001
001
001
001
001
001
001
001
001
001

1%

N016765

001

FLUOROMETHOLONE; SULFACETAMIDE SODIUM

SUSPENSION/DROPS; OPHTHALMIC
FML-S
ALLERGAN
0.1%;10%

FLUOROURACIL
INJECTABLE; INJECTION
ADRUCIL
PHARMACIA AND UPJOHN
TEVA PARENTERAL
FLUOROURACIL
ABIC
ABRAXIS PHARM

APP PHARMS
BEDFORD
MARCHAR
SMITH AND NEPHEW

VALEANT
WATSON LABS
SOLUTION; TOPICAL
FLUOROPLEX
ELORAC

Oct 18, 1991

Aug 28, 1991
Mar
Mar
Jan
Mar
Mar
Nov
Jan
Jan
Dec
Dec
Mar

04,
21,
12,
12,
24,
15,
26,
18,
28,
28,
26,

1986
1986
1987
1987
1999
2000
1988
1983
1984
1984
1987

Oct 13, 1982

FLUOXETINE HYDROCHLORIDE
CAPSULE; ORAL
FLUOXETINE
MUTUAL PHARMA
WATSON LABS

EQ
EQ
EQ
EQ

FLUOXETINE HYDROCHLORIDE
BARR
EQ
PAR PHARM
EQ
EQ
EQ
SANDOZ
EQ
EQ
PROZAC
LILLY
EQ
SOLUTION; ORAL
FLUOXETINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC EQ
HI TECH PHARMA
EQ
PROZAC
LILLY
EQ
TABLET; ORAL
FLUOXETINE HYDROCHLORIDE
BARR
EQ
IVAX SUB TEVA PHARMS EQ
EQ
SANDOZ
EQ

10MG
20MG
10MG
20MG

BASE
BASE
BASE
BASE

A075787
A075787
A075662
A075662

001
002
001
002

Jan
Jan
Jan
Jan

29,
29,
29,
29,

2002
2002
2002
2002

40MG
10MG
20MG
40MG
10MG
20MG

BASE
BASE
BASE
BASE
BASE
BASE

A076251
A076922
A076922
A076922
A075807
A075807

001
001
002
003
001
002

May
Dec
Dec
Dec
Jan
Jan

18,
16,
16,
16,
29,
29,

2005
2004
2004
2004
2002
2002

60MG BASE

N018936

004

Jun 15, 1999

20MG BASE/5ML
20MG BASE/5ML

A075690
A075525

001
001

Jan 31, 2002

Jun 27, 2002

20MG BASE/5ML

N020101

001

Apr 24, 1991

10MG
10MG
40MG
10MG

A075810
A075865
A075865
A076024

001
001
003
001

Feb
Feb
Aug
Jan

BASE
BASE
BASE
BASE

01,
28,
30,
29,

2002
2002
2004
2002

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DISCONTINUED DRUG PRODUCT LIST

6 - 145 (of 346)

FLUOXETINE HYDROCHLORIDE
TABLET; ORAL
PROZAC
LILLY

EQ 10MG BASE
EQ 20MG BASE

N020974
N020974

001
002

Mar 09, 1999

Mar 09, 1999

10MG

A087196

001

10MG
2MG
5MG
10MG

A088221
A088260
A088265
A088309

001
001
001
001

2MG
5MG
10MG

N010611
N010611
N010611

002
006
010

2MG
5MG

N011359
N011359

001
002

25MG/ML
25MG/ML

A074966
A074795

001
001

25MG/ML

N016727

001

25MG/ML

N016110

001

A073058

001

N016008

001

A070533

001

Nov 07, 1985

A081310

001

Apr 29, 1993

N012145

003

N011751

005

A088555
A088544
A088527
A088550

001
001
001
001

N012034
N012034
N012034
N012034

001
004
005
006

FLUOXYMESTERONE
TABLET; ORAL
ANDROID-F
VALEANT PHARM INTL
FLUOXYMESTERONE
VALEANT PHARM INTL
WATSON LABS

HALOTESTIN
PHARMACIA AND UPJOHN

ORA-TESTRYL
BRISTOL MYERS SQUIBB

May
Dec
Dec
Dec

05,
06,
06,
06,

1983
1983
1983
1983

FLUPHENAZINE DECANOATE
INJECTABLE; INJECTION
FLUPHENAZINE DECANOATE
HOSPIRA
TEVA PARENTERAL
PROLIXIN DECANOATE
BRISTOL MYERS SQUIBB

Apr 16, 1998

Sep 10, 1996

FLUPHENAZINE ENANTHATE
INJECTABLE; INJECTION
PROLIXIN ENANTHATE
APOTHECON

FLUPHENAZINE HYDROCHLORIDE
CONCENTRATE; ORAL
FLUPHENAZINE HYDROCHLORIDE
TEVA PHARMS
5MG/ML
PERMITIL
SCHERING
5MG/ML
PROLIXIN
APOTHECON
5MG/ML
ELIXIR; ORAL
FLUPHENAZINE HYDROCHLORIDE
TEVA PHARMS
2.5MG/5ML
PROLIXIN
APOTHECON
2.5MG/5ML
INJECTABLE; INJECTION
PROLIXIN
APOTHECON
2.5MG/ML
TABLET; ORAL
FLUPHENAZINE HYDROCHLORIDE
WATSON LABS
1MG
2.5MG
5MG
10MG
PERMITIL
SCHERING
0.25MG
2.5MG
5MG
10MG

Aug 30, 1991

Dec
Dec
Dec
Dec

18,
18,
18,
18,

1987
1987
1987
1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 146 (of 346)

FLUPHENAZINE HYDROCHLORIDE
TABLET; ORAL
PROLIXIN
APOTHECON

1MG
2.5MG
5MG
10MG
TABLET, EXTENDED RELEASE; ORAL
PERMITIL
SCHERING
1MG

N011751
N011751
N011751
N011751

004
001
003
002

N012419

004

1.5MG

N012259

002

0.05%

N012806

002

0.05%

A087203

001

0.025%
0.05%

N012806
N012806

004
001

0.05%;EQ 3.5MG BASE/GM

N050346

001

0.05%;EQ 3.5MG BASE/GM

N050345

001

15MG
30MG

N016721
N016721

001
002

FLURAZEPAM HYDROCHLORIDE
HALSEY
15MG
30MG
MUTUAL PHARM
15MG
30MG
PAR PHARM
15MG
30MG
PUREPAC PHARM
15MG
30MG
SANDOZ
15MG
30MG
SUPERPHARM
15MG
30MG
USL PHARMA
15MG
30MG
WARNER CHILCOTT
15MG
30MG
WATSON LABS
15MG

A071808
A071809
A070454
A070455
A070444
A070445
A071927
A071551
A071716
A071717
A071659
A071660
A070562
A070563
A071767
A071768
A072368

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

FLUPREDNISOLONE
TABLET; ORAL
ALPHADROL
PHARMACIA AND UPJOHN

FLURANDRENOLIDE
CREAM; TOPICAL
CORDRAN SP
WATSON PHARMS
LOTION; TOPICAL
FLURANDRENOLIDE
ALPHARMA US PHARMS
OINTMENT; TOPICAL
CORDRAN
WATSON PHARMS

Apr 29, 1982

FLURANDRENOLIDE; NEOMYCIN SULFATE

CREAM; TOPICAL
CORDRAN-N
LILLY
OINTMENT; TOPICAL
CORDRAN-N
LILLY

FLURAZEPAM HYDROCHLORIDE
CAPSULE; ORAL
DALMANE
VALEANT PHARM INTL

Jan
Jan
Aug
Aug
Mar
Mar
Sep
Sep
Jul
Jul
Aug
Aug
Jul
Jul
Dec
Dec
Mar

07,
07,
04,
04,
20,
20,
09,
09,
31,
31,
04,
04,
09,
09,
04,
04,
30,

1988
1988
1986
1986
1986
1986
1987
1987
1991
1991
1988
1988
1987
1987
1987
1987
1989

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DISCONTINUED DRUG PRODUCT LIST

6 - 147 (of 346)

FLURBIPROFEN
TABLET; ORAL
FLURBIPROFEN
IVAX SUB TEVA PHARMS
PLIVA
SANDOZ
TEVA
THERAGEN

50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
100MG

A074411
A074411
A074647
A074647
A074448
A074448
A074405
A074405
A074560

001
002
001
002
001
002
002
001
002

May
May
Apr
Apr
Jul
Jul
May
May
May

31,
31,
01,
01,
28,
28,
24,
24,
16,

1995
1995
1997
1997
1995
1995
1995
1995
1997

125MG

N018554

001

Jan 27, 1989

N020548
N020548
N020548

001
002
003

Mar 27, 1996

Mar 27, 1996
Mar 27, 1996

A077145

001

Jun 14, 2005

N020549
N020549
N020549

001
002
003

Nov 07, 1997

Nov 07, 1997
Nov 07, 1997

25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG

A075901
A075901
A075901
A075898
A075898
A075898
A076125
A076125
A076125
A075950
A075950
A075887
A075887
A075887
A075899
A075899
A075899
A075894
A075894
A075894

001
002
003
001
002
003
001
002
003
001
002
001
002
003
001
002
003
001
002
003

Dec
Dec
Dec
Mar
Mar
Mar
Apr
Apr
Apr
Oct
Oct
Jan
Jan
Jan
Jan
Jan
Jan
Apr
Apr
Apr

28,
28,
28,
12,
12,
12,
29,
29,
29,
15,
15,
05,
05,
05,
17,
17,
17,
18,
18,
18,

2000
2000
2000
2001
2001
2001
2002
2002
2002
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001
2001

25MG
50MG
100MG
150MG

N020243
N020243
N020243
N020243

001
002
003
004

Dec
Dec
Dec
Dec

05,
05,
05,
05,

1994
1994
1994
1994

FLUTAMIDE
CAPSULE; ORAL
EULEXIN
SCHERING

FLUTICASONE PROPIONATE
AEROSOL, METERED; INHALATION
FLOVENT
GLAXOSMITHKLINE
0.044MG/INH
0.11MG/INH
0.22MG/INH
OINTMENT; TOPICAL
FLUTICASONE PROPIONATE
TARO PHARM INDS
0.005%
POWDER; INHALATION
FLOVENT
GLAXOSMITHKLINE
0.044MG/INH
0.088MG/INH
0.22MG/INH

FLUVOXAMINE MALEATE
TABLET; ORAL
FLUVOXAMINE MALEATE
ACTAVIS ELIZABETH

IVAX SUB TEVA PHARMS

MUTUAL PHARM

MYLAN
SANDOZ

SYNTHON PHARMS

WATSON LABS

LUVOX
SOLVAY

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6 - 148 (of 346)

FOLIC ACID
INJECTABLE; INJECTION
FOLIC ACID
BEN VENUE
FOLVITE
HIKMA (MAPLE)
TABLET; ORAL
FOLIC ACID
BARR
EVERYLIFE
HALSEY
IMPAX LABS
IVAX SUB TEVA PHARMS
LANNETT
LILLY
MK LABS
MUTUAL PHARM
NEXGEN PHARMA INC
PHARMERAL
PIONEER PHARMS
PUREPAC PHARM
SANDOZ
TABLICAPS
UDL
USL PHARMA
VALEANT PHARM INTL
VANGARD
VINTAGE PHARMS
WATSON LABS
WHITEWORTH TOWN PLSN
FOLICET
MISSION PHARMA
FOLVITE
HIKMA (MAPLE)

5MG/ML

A081066

001

Dec 29, 1993

5MG/ML

N005897

008

1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG
1MG

A089177
A080755
A083598
A080686
A083000
A080816
N006135
A083526
A040582
A084915
A084158
A088949
A080784
A084472
A083133
A088199
A087828
A080903
A088730
A086296
A083141
A085141
A080691

001
001
001
001
001
001
003
001
001
001
001
001
001
001
002
001
001
001
001
001
001
002
002

1MG

A087438

001

1MG

N005897

004

75 IU/VIAL
150 IU/VIAL

N020582
N020582

001
002

Sep 29, 1997

Sep 29, 1997

150 IU/0.18ML

N021211

003

Feb 11, 2004

37.5 IU/VIAL
37.5 IU/VIAL
75 IU/VIAL
150 IU/VIAL
150 IU/VIAL

N020378
N021765
N020378
N020378
N021765

003
001
001
002
003

May
Mar
Sep
Sep
Mar

N020961

001

Aug 26, 1998

N021592

001

Dec 15, 2006

Jan 08, 1986

Jul 18, 2005

Sep 13, 1985

Mar 29, 1983

May 13, 1982
Mar 23, 1984

FOLLITROPIN ALFA/BETA
INJECTABLE; IM-SC
FOLLISTIM
ORGANON USA INC
INJECTABLE; SUBCUTANEOUS
FOLLISTIM AQ
ORGANON USA INC
GONAL-F
EMD SERONO

25,
25,
29,
29,
25,

2000
2004
1997
1997
2004

FOMIVIRSEN SODIUM
INJECTABLE; INJECTION
VITRAVENE PRESERVATIVE FREE
NOVARTIS
6.6MG/ML

FORMOTEROL FUMARATE
POWDER; INHALATION
FORADIL CERTIHALER
NOVARTIS

0.0085MG/INH

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6 - 149 (of 346)

FOSINOPRIL SODIUM
TABLET; ORAL
FOSINOPRIL SODIUM
SANDOZ

10MG
20MG
40MG

A076188
A076188
A076188

001
002
003

Oct 08, 2004

Oct 08, 2004
Oct 08, 2004

A076945
A076945
A077144
A077144

001
002
001
002

Jul
Jul
Aug
Aug

N020286
N020286

002
001

Nov 30, 1994

Nov 30, 1994

EQ 50MG PHENYTOIN NA/ML

N020450

001

Aug 05, 1996

50MG/15ML

N011323

002

100MG

N011270

002

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

N018507
N019036
A070014
A070095
A070096
A071439
N018267
A072080
A074337
A074017
A070017
A070023
A070078
N018420
A070019
A070604
N018670

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

10MG/ML

N016363

001

10MG/ML

N017688

001

20MG
40MG
20MG
40MG
20MG

N018753
N018753
N018868
N018868
A070043

001
002
001
002
001

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

TABLET; ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
TEVA
10MG;12.5MG
20MG;12.5MG
WATSON LABS
10MG;12.5MG
20MG;12.5MG
MONOPRIL-HCT
BRISTOL MYERS SQUIBB 10MG;12.5MG
20MG;12.5MG

05,
05,
16,
16,

2006
2006
2005
2005

FOSPHENYTOIN SODIUM
INJECTABLE; INJECTION
CEREBYX
PARKE DAVIS

FURAZOLIDONE
SUSPENSION; ORAL
FUROXONE
SHIRE
TABLET; ORAL
FUROXONE
SHIRE

FUROSEMIDE
INJECTABLE; INJECTION
FUROSEMIDE
ABRAXIS PHARM
ASTRAZENECA

BAXTER HLTHCARE
HOSPIRA
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
INTL MEDICATION
KALAPHARM
MUTUAL PHARM

Jul
Aug
Sep
Sep
Sep
Sep

30,
13,
09,
09,
09,
14,

1982
1984
1985
1985
1985
1990

Aug
Oct
Jun
Dec
Feb
Feb
Feb
Sep
Jan
Jul

13,
31,
30,
15,
05,
05,
26,
22,
02,
20,

1991
1994
1994
1986
1986
1986
1982
1986
1987
1982

Feb
Feb
Jun
Jun
Sep

28,
28,
28,
28,
26,

1984
1984
1983
1983
1985

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6 - 150 (of 346)

FUROSEMIDE
TABLET; ORAL
FUROSEMIDE
MUTUAL PHARM
SANDOZ
SUPERPHARM
WARNER CHILCOTT

WATSON LABS

40MG
80MG
40MG
20MG
40MG
20MG
40MG
80MG
20MG
40MG
40MG

N018790
A070100
N018750
N018370
N018370
N018419
N018419
N018419
N018369
A070413
N018369

001
001
002
002
001
001
002
003
001
001
002

Nov
Jan
Jul
Jun
Feb
Jan
Jan
Nov
May
Feb
May

29,
26,
30,
26,
10,
31,
31,
13,
14,
26,
14,

1983
1988
1984
1984
1983
1983
1983
1984
1982
1986
1982

100MG
300MG
400MG
100MG
300MG
400MG
100MG
100MG
300MG
300MG
400MG
400MG

A075477
A075477
A075477
A076537
A076537
A076537
A075428
A075539
A075428
A075539
A075428
A075539

001
002
003
001
002
003
001
001
002
002
003
003

Mar
Mar
Mar
Jun
Jun
Jun
Jan
Apr
Jan
Apr
Jan
Apr

23,
23,
23,
30,
30,
30,
24,
06,
24,
06,
24,
06,

2005
2005
2005
2005
2005
2005
2006
2005
2006
2005
2006
2005

600MG
800MG
600MG
600MG
800MG
800MG
600MG
800MG

A076605
A076605
A076120
A076877
A076120
A076877
A075827
A075827

001
002
001
001
002
002
001
002

Sep
Sep
Jan
Jul
Jan
Jul
Dec
Dec

14,
14,
27,
06,
27,
06,
15,
15,

2005
2005
2006
2006
2006
2006
2004
2004

14.35GM/50ML (287MG/ML)

N022066

001

Sep 05, 2007

A077585
A077585
A077585
A077604
A077604
A077604

001
002
003
001
002
003

Sep
Sep
Sep
Feb
Feb
Feb

N007842
N007842

001
002

GABAPENTIN
CAPSULE; ORAL
GABAPENTIN
IVAX SUB TEVA PHARMS

MUTUAL PHARM

SANDOZ

TABLET; ORAL
GABAPENTIN
RANBAXY
SANDOZ

TEVA

GADODIAMIDE
INJECTABLE; INJECTION
OMNISCAN
GE HEALTHCARE

GALANTAMINE HYDROBROMIDE
TABLET; ORAL
GALANTAMINE HYDROBROMIDE
ACTAVIS ELIZABETH
EQ
EQ
EQ
YABAO BIOPHARMS
EQ
EQ
EQ

4MG BASE
8MG BASE
12MG BASE
4MG BASE
8MG BASE
12MG BASE

GALLAMINE TRIETHIODIDE
INJECTABLE; INJECTION
FLAXEDIL
DAVIS AND GECK

20MG/ML
100MG/ML

15,
15,
15,
06,
06,
06,

2009
2009
2009
2009
2009
2009

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DISCONTINUED DRUG PRODUCT LIST

6 - 151 (of 346)

GALLIUM CITRATE GA-67

INJECTABLE; INJECTION
GALLIUM CITRATE GA 67
GE HEALTHCARE
NEOSCAN
GE HEALTHCARE

1mCi/ML

N017700

001

2mCi/ML

N017655

001

250MG
500MG

N020460
N020460

001
002

Dec 22, 1994

Dec 12, 1997

EQ 500MG BASE/VIAL

A076222

001

Jul 16, 2003

250MG

N021399

001

May 05, 2003

300MG
300MG

A073466
A072929

001
001

Jan 25, 1993

Jan 29, 1993

200MG
300MG

N018422
N018422

001
002

600MG
600MG
600MG
600MG

A074452
A074360
A074615
A074156

001
001
001
001

Feb
Aug
Sep
Oct

5MG/VIAL

N021174

001

May 17, 2000

EQ 0.1% BASE

A060462

001

EQ 0.1% BASE

A062458

001

Sep 01, 1983

EQ 0.1% BASE
EQ 0.1% BASE
EQ 1MG BASE/GM

A062471
A064056
A062530

001
001
001

Sep 27, 1983

Apr 29, 1994
Jul 05, 1984

EQ 10MG BASE/ML
EQ 40MG BASE/ML

A062289
A062289

001
002

EQ 40MG BASE/ML

A062288

001

EQ 1MG BASE/ML
EQ 10MG BASE/ML
EQ 40MG BASE/ML

A061716
A061739
A061716

002
001
001

GANCICLOVIR
CAPSULE; ORAL
CYTOVENE
ROCHE PALO

GANCICLOVIR SODIUM
INJECTABLE; INJECTION
GANCICLOVIR SODIUM
BEDFORD

GEFITINIB
TABLET; ORAL
IRESSA
ASTRAZENECA

GEMFIBROZIL
CAPSULE; ORAL
GEMFIBROZIL
MYLAN
PUREPAC PHARM
LOPID
PFIZER PHARMS
TABLET; ORAL
GEMFIBROZIL
MYLAN
PUREPAC PHARM
SANDOZ
WATSON LABS

16,
31,
29,
24,

1995
1994
1995
1994

GEMTUZUMAB OZOGAMICIN
INJECTABLE; INJECTION
MYLOTARG
WYETH PHARMS INC

GENTAMICIN SULFATE
CREAM; TOPICAL
GARAMYCIN
SCHERING
GENTAFAIR
PHARMAFAIR
GENTAMICIN SULFATE
ALPHARMA US PHARMS
BAUSCH AND LOMB
PHARMADERM
INJECTABLE; INJECTION
APOGEN
KING PHARMS
BRISTAGEN

BRISTOL

GARAMYCIN

SCHERING

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6 - 152 (of 346)

GENTAMICIN SULFATE
INJECTABLE; INJECTION
GENTAFAIR
PHARMAFAIR
GENTAMICIN
INTL MEDICATION

GENTAMICIN SULFATE
ABBOTT

EQ 40MG BASE/ML

A062493

001

Aug 28, 1985

EQ 1MG BASE/ML
EQ 40MG BASE/ML
EQ 100MG BASE/100ML

A062325
A062325
A062325

003
001
004

Jun 23, 1982

A062413
A062413
A062413
A062413
A062413
A062413
A062413
A062413
A062413
A062413
A062251
A062251
A062354
A062340
A062507
A062507
A063149
A063106
A062318
A062318
A062264
A062264

001
002
003
004
005
006
007
008
009
010
002
001
001
001
001
002
001
002
002
001
001
002

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug

11,
11,
11,
11,
11,
11,
11,
11,
11,
11,

1983
1983
1983
1983
1983
1983
1983
1983
1983
1983

Apr
Mar
Jun
Jun
Nov
Nov

05,
28,
06,
06,
21,
21,

1982
1983
1985
1985
1991
1991

A062588
A062588
A062588
A062588
A062588
A062588
A062588
A062588
A062588
A062588

001
002
003
004
005
006
007
008
009
010

Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan

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

1986
1986
1986
1986
1986
1986
1986
1986
1986
1986

A062248
A062248

001
002

N050505

001

N050425

001

A062501

001

Jul 26, 1984

A062443

001

May 26, 1983

A060463

001

A062444

001

May 26, 1983

A062496
A064054
A062534

001
001
001

Mar 14, 1984

Apr 29, 1994
Oct 10, 1984

EQ 1.2MG BASE/ML
EQ 1.4MG BASE/ML
EQ 1.6MG BASE/ML
EQ 1.8MG BASE/ML
EQ 2MG BASE/ML
EQ 60MG BASE/100ML
EQ 70MG BASE/100ML
EQ 80MG BASE/100ML
EQ 90MG BASE/100ML
EQ 100MG BASE/100ML
BAXTER HLTHCARE
EQ 10MG BASE/ML
EQ 40MG BASE/ML
KALAPHARM
EQ 40MG BASE/ML
PHARM SPEC
EQ 40MG BASE/ML
SOLOPAK
EQ 10MG BASE/ML
EQ 40MG BASE/ML
TEVA PARENTERAL
EQ 10MG BASE/ML
EQ 40MG BASE/ML
WATSON LABS
EQ 10MG BASE/ML
EQ 40MG BASE/ML
WYETH AYERST
EQ 10MG BASE/ML
EQ 40MG BASE/ML
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA
EQ 1.2MG BASE/ML
EQ 1.4MG BASE/ML
EQ 1.6MG BASE/ML
EQ 1.8MG BASE/ML
EQ 2MG BASE/ML
EQ 60MG BASE/100ML
EQ 70MG BASE/100ML
EQ 80MG BASE/100ML
EQ 90MG BASE/100ML
EQ 100MG BASE/100ML
U-GENCIN
PHARMACIA AND UPJOHN EQ 10MG BASE/ML
EQ 40MG BASE/ML
INJECTABLE; INTRATHECAL
GARAMYCIN
SCHERING
EQ 2MG BASE/ML
OINTMENT; OPHTHALMIC
GARAMYCIN
SCHERING
EQ 0.3% BASE
GENTACIDIN
NOVARTIS
EQ 0.3% BASE
GENTAFAIR
PHARMAFAIR
EQ 3MG BASE/GM
OINTMENT; TOPICAL
GARAMYCIN
SCHERING
EQ 0.1% BASE
GENTAFAIR
PHARMAFAIR
EQ 0.1% BASE
GENTAMICIN SULFATE
ALPHARMA US PHARMS
EQ 0.1% BASE
BAUSCH AND LOMB
EQ 0.1% BASE
PHARMADERM
EQ 0.1% BASE

Jun 23, 1982

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6 - 153 (of 346)

GENTAMICIN SULFATE
SOLUTION/DROPS; OPHTHALMIC
GARAMYCIN
SCHERING
EQ
GENTACIDIN
NOVARTIS
EQ
GENTAFAIR
PHARMAFAIR
EQ
GENTAMICIN SULFATE
ALCON UNIVERSAL
EQ
PACO
EQ

0.3% BASE

N050039

002

0.3% BASE

A062480

001

Mar 30, 1984

0.3% BASE

A062440

001

May 03, 1983

0.3% BASE
3MG BASE/ML

A062523
A062932

001
001

Nov 25, 1985

Nov 07, 1988

0.4%

A083513

001

5MG

A085017

001

N020622

001

Dec 20, 1996

3MG
6MG

A077366
A077366

001
002

Oct 06, 2005

Oct 06, 2005

5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG

A074378
A074378
A074619
A074619
A074542
A074542
A074387
A074387

001
002
001
002
001
002
001
002

Nov
Nov
Apr
Apr
Jun
Jun
Mar
Mar

2.5MG

N017783

003

May 11, 1993

2.5MG;250MG
2.5MG;500MG
5MG;500MG

N021460
N021460
N021460

001
002
003

Oct 21, 2002

Oct 21, 2002
Oct 21, 2002

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

N012122
N012122

001
002

500MG

N009519

008

GENTIAN VIOLET
SUPPOSITORY; VAGINAL
GVS
SAVAGE LABS
TAMPON; VAGINAL
GENAPAX
KEY PHARMS

GLATIRAMER ACETATE
FOR SOLUTION; SUBCUTANEOUS
COPAXONE
TEVA
20MG/VIAL

GLIMEPIRIDE
TABLET; ORAL
GLIMEPIRIDE
RANBAXY

GLIPIZIDE
TABLET; ORAL
GLIPIZIDE
ENDO PHARMS
PLIVA
SANDOZ
TEVA
GLUCOTROL
PFIZER

28,
28,
04,
04,
20,
20,
04,
04,

1994
1994
1997
1997
1995
1995
1996
1996

GLIPIZIDE; METFORMIN HYDROCHLORIDE

TABLET; ORAL
METAGLIP
BRISTOL MYERS SQUIBB

GLUCAGON HYDROCHLORIDE
INJECTABLE; INJECTION
GLUCAGON
LILLY

GLUTETHIMIDE
CAPSULE; ORAL
DORIDEN
SANOFI AVENTIS US

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6 - 154 (of 346)

GLUTETHIMIDE
TABLET; ORAL
DORIDEN
SANOFI AVENTIS US
GLUTETHIMIDE
HALSEY
LANNETT
SANDOZ
UCB INC
VITARINE
WATSON LABS

250MG
500MG

N009519
N009519

002
005

250MG
500MG
250MG
500MG
500MG
500MG
500MG
500MG
500MG

A089458
A089459
A083475
A085571
A083234
A085171
A087297
A084362
A085763

001
001
001
001
002
001
001
001
001

Oct 10, 1986

Oct 10, 1986

1.5MG
3MG
6MG

A075947
A075947
A075947

001
002
003

Nov 14, 2002

Nov 14, 2002
Nov 14, 2002

1.5MG
3MG
1.5MG
3MG
6MG

A075174
A075174
N020055
N020055
N020055

001
002
001
002
003

Jun
Jun
Apr
Apr
Mar

4.5MG

N020051

003

Sep 24, 1993

1.25MG
2.5MG
5MG

N017498
N017498
N017498

001
002
003

May 01, 1984

May 01, 1984
May 01, 1984

A076821
A076821
A076821

001
002
003

Jan 27, 2005

Jan 27, 2005
Jan 27, 2005

N018522
N017633

001
001

Feb 19, 1982

0.2MG/ML
0.2MG/ML
0.2MG/ML
0.2MG/ML

A088475
A089393
A081169
A086947

001
001
001
001

Jun
Jun
Sep
Jun

0.2MG/ML

N014764

001

1MG
1MG
2MG
2MG

A085562
A086902
A085563
A086178

001
001
001
001

GLYBURIDE
TABLET; ORAL
GLYBURIDE
ACTAVIS TOTOWA

GLYBURIDE (MICRONIZED)
SANDOZ
SANOFI AVENTIS US

GLYNASE
PHARMACIA AND UPJOHN
MICRONASE
PHARMACIA AND UPJOHN

22,
22,
17,
17,
08,

1998
1998
1992
1992
2000

GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET; ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDE
TEVA
1.25MG;250MG
2.5MG;500MG
5MG;500MG

GLYCINE
SOLUTION; IRRIGATION
GLYCINE 1.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
1.5GM/100ML
HOSPIRA
1.5GM/100ML

GLYCOPYRROLATE
INJECTABLE; INJECTION
GLYCOPYRROLATE
ABRAXIS PHARM
HOSPIRA
TEVA PARENTERAL
WATSON LABS
ROBINUL
ROBINS AH
TABLET; ORAL
GLYCOPYRROLATE
WATSON LABS

12,
15,
10,
24,

1984
1988
1991
1983

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6 - 155 (of 346)

GLYCOPYRROLATE
TABLET; ORAL

GLYCOPYRROLATE

WATSON LABS

2MG

A086900

001

0.8MG/VIAL
3.2MG/VIAL

N019687
N019687

001
002

Oct 10, 1989

Oct 10, 1989

EQ 0.1MG BASE/VIAL
EQ 0.2MG BASE/VIAL
EQ 0.5MG BASE/VIAL

N018123
N018123
N018123

001
002
003

Sep 30, 1982

Sep 30, 1982
Sep 30, 1982

5,000 UNITS/VIAL
10,000 UNITS/VIAL
20,000 UNITS/VIAL

N017055
N017055
N017055

001

002

003

5,000 UNITS/VIAL
15,000 UNITS/VIAL
20,000 UNITS/VIAL
5,000 UNITS/VIAL
10,000 UNITS/VIAL
2,000 UNITS/VIAL
2,000 UNITS/VIAL
5,000 UNITS/VIAL
15,000 UNITS/VIAL
20,000 UNITS/VIAL

N017067
N017067
N017067
N017054
N017054
N017016
N017016
N017016
N017016
N017016

001

004

003

001

002

009
011
006
010
004

10,000 UNITS/VIAL

N017056

001

A062818

001

Oct 11, 1988

A062788

001

Jun 11, 1987

A062383

001

Aug 31, 1982

A060427

001

N020239
N020239
N020239
N020239

003
004
001
002

Sep
Mar
Dec
Mar

N021238

001

Jun 27, 2001

GONADORELIN ACETATE
INJECTABLE; INJECTION
LUTREPULSE KIT
FERRING

GONADORELIN HYDROCHLORIDE
INJECTABLE; INJECTION

FACTREL

HIKMA (MAPLE)

GONADOTROPIN, CHORIONIC
INJECTABLE; INJECTION
A.P.L.
FERRING

CHORIONIC GONADOTROPIN
APP PHARMS

BEL MAR
FERRING

FOLLUTEIN

BRISTOL MYERS SQUIBB

Dec 27, 1984

Feb 16, 1990
Feb 15, 1985

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS; OPHTHALMIC
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
0.025MG/ML;EQ 1.75MG BASE/ML;10,000
UNITS/ML
NEO-POLYCIN
DOW PHARM
0.025MG/ML;EQ 1.75MG BASE/ML;10,000
UNITS/ML

GRANISETRON HYDROCHLORIDE
INJECTABLE; INJECTION

KYTRIL

ROCHE

SOLUTION; ORAL
KYTRIL
ROCHE

EQ
EQ
EQ
EQ

0.1MG BASE/ML (EQ 0.1MG BASE/ML)

1MG BASE/ML (EQ 1MG BASE/ML)
3MG BASE/ML
4MG BASE/4ML (EQ 1MG BASE/ML)

EQ 2MG BASE/10ML

17,
11,
29,
11,

2004
1994
1993
1994

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GRANISETRON HYDROCHLORIDE
TABLET; ORAL
GRANISETRON HYDROCHLORIDE
BARR
EQ 1MG BASE
KYTRIL
ROCHE
EQ 1MG BASE
EQ 2MG BASE

A078221

001

Dec 31, 2007

N020305
N020305

001
002

Mar 16, 1995

Jun 15, 1998

N020695
N020695
N020695

001
002
003

Nov 06, 1997

May 14, 1998
May 14, 1998

125MG
250MG

N050051
N050051

002
001

125MG/5ML

N050448

001

250MG
500MG

A060569
A060569

002
001

125MG
250MG
500MG
125MG
250MG

A060618
A060618
A060618
A062279
A062279

001
002
003
001
002

500MG

A060212

001

125MG
250MG

A061996
A061996

001
002

165MG

A061996

003

Apr 06, 1982

330MG

A061996

004

Apr 06, 1982

125MG
165MG
250MG
330MG

A062178
A062438
A062178
A062438

001
001
002
002

165MG

A062645

001

Jun 30, 1992

330MG

A062646

001

Jun 30, 1992

A074517
A074517
A074267
A074267
A074025

001
002
001
002
001

Sep
Sep
Jun
Jun
Feb

GREPAFLOXACIN HYDROCHLORIDE
TABLET; ORAL
RAXAR
OTSUKA

EQ 200MG BASE
EQ 400MG BASE
EQ 600MG BASE

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

ORTHONEUTROGENA
GRISACTIN
WYETH AYERST

GRISEOFULVIN, ULTRAMICROCRYSTALLINE
TABLET; ORAL
FULVICIN P/G
ELORAC
FULVICIN P/G 165
ELORAC
FULVICIN P/G 330
ELORAC
GRISACTIN ULTRA
WYETH AYERST

ULTRAGRIS-165
PLIVA
ULTRAGRIS-330
PLIVA

Nov 17, 1983

Nov 17, 1983

GUANABENZ ACETATE
TABLET; ORAL
GUANABENZ ACETATE
SANDOZ
TEVA PHARMS
WATSON LABS

EQ
EQ
EQ
EQ
EQ

4MG
8MG
4MG
8MG
4MG

BASE
BASE
BASE
BASE
BASE

30,
30,
01,
01,
28,

1998
1998
1994
1994
1994

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6 - 157 (of 346)

GUANABENZ ACETATE
TABLET; ORAL
GUANABENZ ACETATE
WATSON LABS
WYTENSIN
WYETH AYERST

EQ 8MG BASE

A074025

002

Feb 28, 1994

EQ 4MG BASE
EQ 8MG BASE
EQ 16MG BASE

N018587
N018587
N018587

001
002
003

Sep 07, 1982

Sep 07, 1982
Sep 07, 1982

10MG
25MG

N018104
N018104

001
002

Dec 29, 1982

Dec 29, 1982

10MG SULFATE
25MG SULFATE

A086113
A086114

001
001

Mar 26, 1985

Mar 26, 1985

10MG SULFATE
25MG SULFATE

N012329
N012329

001
002

N013553

001

A074762
A074762

001
002

Jun 25, 1997

Jun 25, 1997

N019032

003

Nov 07, 1988

20MG
40MG

N017736
N017736

003
004

0.025%

N017818

001

0.1%

N018234

001

0.025%

N018125

001

0.1%

N017823

001

0.05%

A077109

001

GUANADREL SULFATE
TABLET; ORAL
HYLOREL
PHARMACIA AND UPJOHN

GUANETHIDINE MONOSULFATE
TABLET; ORAL
GUANETHIDINE MONOSULFATE
WATSON LABS
EQ
EQ
ISMELIN
NOVARTIS
EQ
EQ

GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE

TABLET; ORAL
ESIMIL
NOVARTIS

10MG;25MG

GUANFACINE HYDROCHLORIDE
TABLET; ORAL
GUANFACINE HYDROCHLORIDE
WATSON LABS
EQ 1MG BASE
EQ 2MG BASE
TENEX
PROMIUS PHARMA
EQ 3MG BASE

HALAZEPAM
TABLET; ORAL
PAXIPAM
SCHERING

HALCINONIDE
CREAM; TOPICAL
HALOG
WESTWOOD SQUIBB
HALOG-E
RANBAXY
OINTMENT; TOPICAL
HALOG
BRISTOL MYERS SQUIBB
SOLUTION; TOPICAL
HALOG
RANBAXY

HALOBETASOL PROPIONATE
OINTMENT; TOPICAL
HALOBETASOL PROPIONATE
ACTAVIS MID ATLANTIC

Jun 14, 2005

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6 - 158 (of 346)

HALOFANTRINE HYDROCHLORIDE
TABLET; ORAL
HALFAN
GLAXOSMITHKLINE

250MG

N020250

001

Jul 24, 1992

0.5MG
1MG
2MG
5MG
10MG
20MG

N015921
N015921
N015921
N015921
N015921
N015921

001
002
003
004
005
006

Feb 02, 1982

1MG

N017079

001

0.5MG
1MG
2MG
5MG
10MG
20MG
0.5MG
1MG
2MG
5MG
10MG
20MG
0.5MG
1MG
2MG
5MG
10MG
20MG
20MG
0.5MG
1MG
2MG
5MG
10MG
20MG
0.5MG
1MG
2MG
5MG
0.5MG
1MG
2MG
5MG
10MG
20MG
0.5MG
1MG
2MG
5MG
10MG
20MG
0.5MG
1MG
2MG
5MG
10MG

A071216
A071217
A071218
A071219
A071220
A071221
A072727
A072728
A072729
A072730
A072731
A072732
A071156
A071157
A071172
A071212
A071173
A071177
A071328
A071071
A071072
A071073
A071074
A071075
A071076
A071255
A071269
A071256
A071257
A071128
A071129
A071130
A071131
A071132
A071133
A071722
A071723
A071724
A071725
A072121
A072122
A070720
A070721
A070722
A070723
A070724

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

HALOPERIDOL
TABLET; ORAL
HALDOL
ORTHO MCNEIL

HALDOL SOLUTAB
ORTHO MCNEIL PHARM
HALOPERIDOL
DURAMED PHARMS BARR

LEDERLE

MUTUAL PHARM

PAR PHARM
PUREPAC PHARM

QUANTUM PHARMICS

ROXANE

ROYCE LABS

SCS

Dec
Dec
Dec
Dec
Jul
Jul
Sep
Sep
Sep
Sep
Sep
Sep
Jan
Jan
Jan
Jan
Jan
Jan
Jul
Nov
Nov
Nov
Nov
Aug
Aug
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
May
May
Dec
Dec
Dec
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun

04,
04,
04,
04,
07,
07,
19,
19,
19,
19,
19,
19,
02,
02,
02,
07,
07,
07,
20,
03,
03,
03,
03,
04,
04,
17,
17,
17,
17,
17,
17,
17,
17,
12,
12,
24,
24,
24,
24,
24,
24,
10,
10,
10,
10,
10,

1986
1986
1986
1986
1987
1987
1989
1989
1989
1989
1989
1989
1987
1987
1987
1988
1988
1988
1987
1986
1986
1986
1986
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1987
1986
1986
1986
1986
1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 159 (of 346)

HALOPERIDOL
TABLET; ORAL
HALOPERIDOL
SCS
VINTAGE

WATSON LABS

20MG
0.5MG
1MG
2MG
5MG
10MG
0.5MG
0.5MG
1MG
1MG
2MG
2MG
5MG
5MG
10MG
10MG
20MG
20MG

A070725
A071233
A071234
A071235
A071236
A071237
A070981
A071571
A070982
A071572
A070983
A071573
A070984
A071374
A071375
A072113
A071376
A072353

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Sep
Nov
Nov
Nov
Nov
Jul
Mar
Jun
Mar
Jun
Mar
Jun
Mar
Jun
Jun
Aug
Jun
Aug

24,
03,
03,
03,
03,
20,
06,
03,
06,
03,
06,
03,
06,
03,
03,
27,
03,
27,

1986
1986
1986
1986
1986
1987
1987
1988
1987
1988
1987
1988
1987
1988
1988
1991
1988
1991

EQ
EQ
EQ
EQ

A075176
A075176
A076463
A076463

001
002
001
002

Feb
Feb
Jun
Jun

09,
09,
24,
24,

2000
2000
2005
2005

EQ 2MG BASE/ML

N015922

001

EQ
EQ
EQ
EQ

BASE/ML
BASE/ML
BASE/ML
BASE/ML

A070318
A070710
A070726
A071015

001
001
001
001

Apr
Mar
Jun
Aug

11,
07,
10,
25,

1986
1986
1986
1987

EQ 2MG BASE/ML

A072045

001

Apr 12, 1988

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

A071187
A072516
A072517
A076464
A070802
A070800
A070801
A070864
A070713
A070714
A070744

001
001
001
001
001
001
001
001
001
001
001

Jan
Feb
Feb
Sep
Dec
Dec
Dec
Dec
May
May
May

EQ 1MG BASE/ML

A074536

001

Nov 02, 1995

1%

N016942

001

HALOPERIDOL DECANOATE
INJECTABLE; INJECTION
HALOPERIDOL DECANOATE
HOSPIRA
SANDOZ

50MG BASE/ML
100MG BASE/ML
50MG BASE/ML
100MG BASE/ML

HALOPERIDOL LACTATE
CONCENTRATE; ORAL
HALDOL
ORTHO MCNEIL
HALOPERIDOL
ALPHARMA
MORTON GROVE
SCS
TEVA
HALOPERIDOL INTENSOL
ROXANE
INJECTABLE; INJECTION
HALOPERIDOL
ABRAXIS PHARM
MARSAM PHARMS LLC
SANDOZ
SMITH AND NEPHEW
SOLOPAK

WATSON LABS

SOLUTION; ORAL
HALOPERIDOL LACTATE
ACTAVIS MID ATLANTIC

2MG
2MG
2MG
2MG

5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG
5MG

HALOPROGIN
CREAM; TOPICAL
HALOTEX
WESTWOOD SQUIBB

20,
25,
25,
29,
14,
14,
14,
14,
17,
17,
17,

1987
1993
1993
2004
1987
1987
1987
1987
1988
1988
1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 160 (of 346)

HALOPROGIN
SOLUTION; TOPICAL
HALOTEX
WESTWOOD SQUIBB

1%

N016943

001

99.99%

N011338

001

99.99%
99.99%
99.99%

A084977
A080810
A083254

001
001
001

25,000 UNITS/ML

N018237

001

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

N005264
A086357
A086357
A089063
A089064
N017346
A087904
A087958
A088458
A088580
A087906
A087959
A088460
A088581
A087903
A088457
A087905
A088459

010
001
002
001
001
006
001
001
001
001
001
001
001
001
001
001
001
001

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
5,000 UNITS/ML
10,000 UNITS/ML
20,000 UNITS/ML
5,000 UNITS/0.5ML
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

N017033
N017979
N017979
N017979
N017486
N017486
N017486
N017486
N017486
N017651
N017029
N017651
N017651
N017037
N017007
N017007
N017007
N017007
N017007
N017007
N017007
N017007

001
001
003
002
001
002
003
004
005
005
002
003
008
013
001
007
002
010
003
004
005
006

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

APP PHARMS

BAXTER HLTHCARE
BAXTER HLTHCARE CORP

Oct 09, 1985

Oct 09, 1985
Apr
Apr
Jul
Oct
Apr
Apr
Jul
Oct
Apr
Oct
Apr
Jul

20,
20,
26,
25,
20,
20,
26,
25,
20,
25,
20,
26,

1983
1983
1984
1984
1983
1983
1984
1984
1983
1984
1983
1984

Apr 07, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 161 (of 346)

HEPARIN SODIUM
INJECTABLE; INJECTION
HEPARIN SODIUM
CHAMBERLIN PARENTERL

1,000 UNITS/ML
N017130
5,000 UNITS/ML
N017130
10,000 UNITS/ML
N017130
20,000 UNITS/ML
N017130
DELL LABS
1,000 UNITS/ML
N017540
5,000 UNITS/ML
N017540
10,000 UNITS/ML
N017540
20,000 UNITS/ML
N017540
40,000 UNITS/ML
N017540
HOSPIRA
2,500 UNITS/ML
A088099
10,000 UNITS/ML
A040095
LILLY
1,000 UNITS/ML
N005521
10,000 UNITS/ML
N005521
20,000 UNITS/ML
N005521
LUITPOLD
1,000 UNITS/ML
A087452
MARSAM PHARMS LLC
1,000 UNITS/ML
A040007
1,000 UNITS/ML
A040008
ORGANON USA INC
1,000 UNITS/ML
N000552
5,000 UNITS/ML
N000552
10,000 UNITS/ML
N000552
PARKE DAVIS
1,000 UNITS/ML
N017346
5,000 UNITS/ML
N017346
7,500 UNITS/ML
N017346
10,000 UNITS/ML
N017346
20,000 UNITS/ML
N017346
PHARM SPEC
1,000 UNITS/ML
N017780
5,000 UNITS/ML
N017780
10,000 UNITS/ML
N017780
20,000 UNITS/ML
N017780
40,000 UNITS/ML
N017780
PHARMACIA AND UPJOHN 1,000 UNITS/ML
N004570
5,000 UNITS/ML
N004570
10,000 UNITS/ML
N004570
SMITH AND NEPHEW
1,000 UNITS/ML
A088239
SOLOPAK
1,000 UNITS/ML
A087043
5,000 UNITS/ML
A087077
5,000 UNITS/0.5ML
A087395
10,000 UNITS/ML
A087107
10,000 UNITS/0.5ML
A087363
WATSON LABS
1,000 UNITS/ML
N017064
2,500 UNITS/ML
N017064
3,000 UNITS/ML
N017064
4,000 UNITS/ML
N017064
5,000 UNITS/ML
N017064
6,000 UNITS/ML
N017064
7,500 UNITS/ML
N017064
10,000 UNITS/ML
N017064
20,000 UNITS/ML
N017064
40,000 UNITS/ML
N017064
HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW
200 UNITS/100ML
N019130
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
200 UNITS/100ML
N019042
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%
HOSPIRA
10,000 UNITS/100ML
N018911
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
2,000 UNITS/100ML
N018814
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
HOSPIRA
10,000 UNITS/100ML
N018911
10,000 UNITS/100ML
N018916

001
002
003
004
001
002
003
004
005
001
001
001
002
004
001
001
001
008
009
010
001
002
003
004
005
001
002
003
004
005
001
002
003
001
001
001
001
001
001
002
015
016
017
003
018
019
004
005
006

Apr 28, 1983

Jul 26, 1996

Oct 31, 1983

Jun 07, 1996
Oct 10, 1995

Jul 26, 1984

001

Dec 31, 1984

001

Mar 29, 1985

006

Jan 30, 1985

002

Jul 09, 1985

001
005

Jan 30, 1985

Jan 31, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 162 (of 346)

HEPARIN SODIUM
INJECTABLE; INJECTION
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA
10,000 UNITS/100ML
N018911
10,000 UNITS/100ML
N018916
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5%
HOSPIRA
5,000 UNITS/100ML
N018911
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
5,000 UNITS/100ML
N019802
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA
5,000 UNITS/100ML
N018911
5,000 UNITS/100ML
N018916
HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW
200 UNITS/100ML
N019130
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
200 UNITS/100ML
N019042
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
HOSPIRA
5,000 UNITS/100ML
N018911
10,000 UNITS/100ML
N018911
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
5,000 UNITS/100ML
N019134
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
5,000 UNITS/100ML
N019802
10,000 UNITS/100ML
N019802
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA
5,000 UNITS/100ML
N018911
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
5,000 UNITS/100ML
N019135
5,000 UNITS/100ML
N019802
HOSPIRA
5,000 UNITS/100ML
N018916
HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE
500 UNITS/100ML
N018609
HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW
1,000 UNITS/100ML
N019130
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
HOSPIRA
100 UNITS/ML
N018911
100 UNITS/ML
N018916
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA
1,000 UNITS/100ML
N018916
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
1,000 UNITS/100ML
N019042
HEPARIN SODIUM PRESERVATIVE FREE
HOSPIRA
2,000 UNITS/ML
N005264
2,500 UNITS/ML
N005264
MARSAM PHARMS LLC
1,000 UNITS/ML
A089464
PHARMA SERVE NY
1,000 UNITS/ML
A086129
LIPO-HEPIN
3M
1,000 UNITS/0.5ML
N017027
1,000 UNITS/ML
N017027
5,000 UNITS/0.5ML
N017027
5,000 UNITS/ML
N017027
7,500 UNITS/0.5ML
N017027
10,000 UNITS/0.5ML
N017027
10,000 UNITS/ML
N017027
15,000 UNITS/0.5ML
N017027
20,000 UNITS/0.5ML
N017027
20,000 UNITS/ML
N017027
40,000 UNITS/ML
N017027
LIQUAEMIN LOCK FLUSH
ORGANON USA INC
100 UNITS/ML
N000552
LIQUAEMIN SODIUM
ORGANON USA INC
1,000 UNITS/ML
N000552
5,000 UNITS/ML
N000552

003
002

Jan 30, 1985

Jan 31, 1984

007

Jan 30, 1985

001

Jul 20, 1992

005
003

Jan 30, 1985

Jan 31, 1984

003

Dec 31, 1984

002

Mar 29, 1985

009
008

Jan 30, 1985

Jan 30, 1985

001

Mar 29, 1985

005
002

Jul 20, 1992

Jul 20, 1992

004

Jan 30, 1985

001
003
009

Mar 29, 1985

Jul 20, 1992
Jan 31, 1984

003

Apr 28, 1982

002

Dec 31, 1984

002
004

Jan 30, 1985

Jan 31, 1984

001

Jan 31, 1984

004

Mar 29, 1985

013
014
001
001

Apr 07, 1986

Apr 07, 1986
Jun 03, 1986

001
006
002
008
010
003
009
011
004
007
005
007
004
003

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DISCONTINUED DRUG PRODUCT LIST

6 - 163 (of 346)

HEPARIN SODIUM
INJECTABLE; INJECTION
LIQUAEMIN SODIUM
ORGANON USA INC

10,000 UNITS/ML
20,000 UNITS/ML
40,000 UNITS/ML
LIQUAEMIN SODIUM PRESERVATIVE FREE
ORGANON USA INC
1,000 UNITS/ML
5,000 UNITS/ML
10,000 UNITS/ML
PANHEPRIN

HOSPIRA

1,000 UNITS/ML
5,000 UNITS/ML
10,000 UNITS/ML
20,000 UNITS/ML
40,000 UNITS/ML
SODIUM HEPARIN
ABRAXIS PHARM
5,000 UNITS/ML
10,000 UNITS/ML
20,000 UNITS/ML
BAXTER HLTHCARE
1,000 UNITS/ML

N000552
N000552
N000552

005
001
002

N000552
N000552
N000552

011
012
013

N005264
N005264
N005264
N005264
N005264

004
006
007
008
009

N017033
N017033
N017033
N017036

002
003
004
001

A061398
N050060
N050060
A061398

001
001
003
002

EQ 225MG AMPICIL
EQ 450MG AMPICIL

A061396
A061396

001
002

0.23%

N017424

001

3%

N018375

001

3%

N017411

001

3%

N008402

001

3%

N017405

001

3%

N019055

001

2%

N006270

003

0.25%

N017421

002

1%

N017412

001

0.25%

N017412

002

0.25%

N017460

001

Apr 11, 1986

Apr 11, 1986
Apr 11, 1986

Mar 04, 1988

HETACILLIN
FOR SUSPENSION; ORAL
VERSAPEN
BRISTOL

EQ
EQ
EQ
EQ

112.5MG AMPICIL/ML
112.5MG AMPICIL/5ML
112.5MG AMPICIL/ML
225MG AMPICIL/5ML

HETACILLIN POTASSIUM
CAPSULE; ORAL
VERSAPEN-K
BRISTOL

HEXACHLOROPHENE
AEROSOL; TOPICAL
SEPTISOL
VESTAL LABS
TURGEX
XTTRIUM
EMULSION; TOPICAL
HEXA-GERM
HUNTINGTON LABS
PHISOHEX
SANOFI AVENTIS US
SOY-DOME
BAYER PHARMS
TURGEX
XTTRIUM
SOAP; TOPICAL
GAMOPHEN
ARBROOK
SOLUTION; TOPICAL
DIAL
DIAL
GERMA-MEDICA
HUNTINGTON LABS
GERMA-MEDICA "MG"
HUNTINGTON LABS
SEPTI-SOFT
CALGON

Nov 30, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 164 (of 346)

HEXACHLOROPHENE
SOLUTION; TOPICAL
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

N017423

001

N017452

001

N018363

001

N017446

001

N017413

001

20MG/ML

N009789

003

25MG

N010599

001

5%

N008472

001

EQ 0.1MG BASE/ML
EQ 0.2MG BASE/ML
EQ 1MG BASE/ML

N000734
N000734
N000734

003
002
001

EQ 0.2MG BASE/ML
EQ 0.5MG BASE/ML
EQ 1MG BASE/ML

N019836
N019836
N019836

001
002
003

10MG

A086308

001

5MG

A086309

001

3MG

A086310

001

N005213

002

Jul 26, 1988

A040285

001

Jul 19, 1999

A088066

001

Jun 28, 1985

HEXAFLUORENIUM BROMIDE
INJECTABLE; INJECTION
MYLAXEN
MEDPOINTE PHARM HLC

HEXOCYCLIUM METHYLSULFATE
TABLET; ORAL
TRAL
ABBOTT

HEXYLCAINE HYDROCHLORIDE
SOLUTION; TOPICAL
CYCLAINE
MERCK

HISTAMINE PHOSPHATE
INJECTABLE; INJECTION
HISTAMINE PHOSPHATE
LILLY

HISTRELIN ACETATE
INJECTABLE; INJECTION
SUPPRELIN
SHIRE

Dec 24, 1991

Dec 24, 1991
Dec 24, 1991

HOMATROPINE METHYLBROMIDE
TABLET; ORAL
HOMAPIN-10
MISSION PHARMA
HOMAPIN-5
MISSION PHARMA
TABLET, CHEWABLE; ORAL
EQUIPIN
MISSION PHARMA

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

SYRUP; ORAL
HYCODAN
ENDO PHARMS
1.5MG/5ML;5MG/5ML
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
IVAX SUB TEVA PHARMS 1.5MG/5ML;5MG/5ML
HYDROPANE
HALSEY
1.5MG/5ML;5MG/5ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 165 (of 346)

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

TABLET; ORAL
HOMATROPRINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
ACTAVIS TOTOWA
1.5MG;5MG
HYCODAN
ENDO PHARMS
1.5MG;5MG

A040295

001

Dec 01, 2000

N005213

001

Jul 26, 1988

6,200 UNITS/VIAL

N021640

001

May 05, 2004

150 UNITS/ML
150 UNITS/VIAL
1,500 UNITS/VIAL

N006343
N006343
N006343

002
006
005

N008303

003

A089532
A088518
A088517
A040373

001
001
001
001

N008303
N008303
N008303
N008303

004
001
002
005

A084301

001

A088560
A088649
A088310
A088311
A089218
A089130
A089222
A089178
A084922
A084923
A084443
A084437
A084469
A084581
A088728
A089359
A084106
A089258
A084107
A089259
A088729
A088177
A088178
A088671
A088657
A088652
A088686
A083241
A083560

001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
002
001
002
001
001
001
001
001
001
001
001
001
001

HYALURONIDASE
INJECTABLE; INJECTION
VITRASE
ISTA PHARMS
WYDASE
BAXTER HLTHCARE

HYDRALAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
APRESOLINE
NOVARTIS
20MG/ML
HYDRALAZINE HYDROCHLORIDE
ABRAXIS PHARM
20MG/ML
SMITH AND NEPHEW
20MG/ML
SOLOPAK
20MG/ML
TEVA PARENTERAL
20MG/ML
TABLET; ORAL
APRESOLINE
NOVARTIS
10MG
25MG
50MG
100MG
DRALZINE
TEVA
25MG
HYDRALAZINE HYDROCHLORIDE
ACTAVIS TOTOWA
25MG
50MG
ASCOT
25MG
50MG
HALSEY
10MG
25MG
50MG
100MG
IMPAX LABS
25MG
50MG
IVAX SUB TEVA PHARMS 10MG
25MG
50MG
100MG
MUTUAL PHARM
10MG
10MG
25MG
25MG
50MG
50MG
100MG
PUREPAC PHARM
25MG
50MG
QUANTUM PHARMICS
10MG
25MG
50MG
100MG
SANDOZ
10MG
25MG

Aug
Apr
Aug
Feb

11,
20,
22,
23,

1987
1984
1985
2000

Oct
Oct
Dec
Dec
Jan
Jan
Jan
Jan

04,
18,
19,
19,
22,
15,
22,
15,

1984
1984
1984
1984
1986
1986
1986
1986

Apr 11, 1985

Jul 25, 1986
May 05, 1986
May
Apr
Jul
Aug
May
Jun
May
May

05,
11,
29,
15,
01,
15,
08,
01,

1986
1985
1983
1983
1984
1984
1984
1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 166 (of 346)

HYDRALAZINE HYDROCHLORIDE
TABLET; ORAL
HYDRALAZINE HYDROCHLORIDE
SANDOZ
50MG
50MG
SUPERPHARM
10MG
25MG
50MG
TG UNITED LABS
10MG
25MG
50MG
100MG
USL PHARMA
25MG
50MG
VANGARD
25MG
50MG
VITARINE
25MG
WATSON LABS
25MG
50MG
WEST WARD
25MG
50MG

A083561
A085088
A088787
A088788
A088789
A088846
A088847
A088848
A088849
A087780
A087751
A087712
A087908
A086088
A085532
A085533
A088240
A088241

001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
002
001
001

A084735
A084810
A084811

001
001
001

A087608
A087213
A087609
A089200
A089201
A085457
A085446
A085440

Aug
Aug
Aug
Feb
Feb
Feb
Feb
Mar
Mar

28,
28,
28,
26,
26,
26,
26,
29,
29,

1984
1984
1984
1985
1985
1985
1985
1982
1982

May 07, 1982

May
May
May
May

24,
25,
27,
27,

1982
1982
1983
1983

001
001
001
001
001
001
001
001

Feb
Feb
Feb
Feb
Feb
Mar
Mar
Mar

08,
08,
08,
09,
09,
04,
04,
04,

1982
1982
1982
1987
1987
1982
1982
1982

A088358

001

Apr 10, 1984

A088356

001

Apr 10, 1984

A088357

001

Apr 10, 1984

A088961

001

Oct 21, 1985

N012026

002

A085827

001

A085373

001

A084897

001

A084291

001

A087085

001

A085771

001

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

CAPSULE; ORAL
APRESAZIDE
NOVARTIS

25MG;25MG
50MG;50MG
100MG;50MG
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
SOLVAY
25MG;25MG
50MG;50MG
100MG;50MG
SUPERPHARM
25MG;25MG
50MG;50MG
WATSON LABS
25MG;25MG
50MG;50MG
100MG;50MG
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50
IVAX PHARMS
100MG;50MG
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25
IVAX PHARMS
25MG;25MG
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50
IVAX PHARMS
50MG;50MG
HYDRA-ZIDE
PAR PHARM
100MG;50MG
TABLET; ORAL
APRESOLINE-ESIDRIX
NOVARTIS
25MG;15MG
HYDRALAZINE AND HYDROCHLORTHIAZIDE
WATSON LABS
25MG;15MG
HYDROCHLOROTHIAZIDE W/ HYDRALAZINE
WATSON LABS
25MG;15MG

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

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 167 (of 346)

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

TABLET; ORAL
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

A084876

001

A083770

001

A083877

001

A088570
A088376
A085549
A087556

001
001
001
001

Apr 10, 1984

Oct 28, 1983

A087709

001

May 13, 1982

A087210

001

N012193

005

A085893
A086298

001
001

25MG;0.1MG

A084617

001

25MG;0.1MG
50MG;0.2MG

N009296
N009296

004
002

A089661
A088587

001
001

Jun 20, 1988

Jul 02, 1984

A088588

001

Jul 02, 1984

N011793
N011793
N011793

005
008
009

A085672
A085054
A085208
A086369
A083554
A087539
A087540
A084771
A087060
A085152
A084135
A084029
A083607
A085098
A084776
A085067
A084776
A084658
A085022

001
002
001
001
001
001
001
001
001
002
001
001
002
001
001
001
002
001
001

HYDRALAZINE HYDROCHLORIDE; RESERPINE

TABLET; ORAL
DRALSERP
SANDOZ
SERPASIL-APRESOLINE
NOVARTIS

HYDROCHLOROTHIAZIDE
SOLUTION; ORAL
HYDROCHLOROTHIAZIDE
MORTON GROVE
50MG/5ML
ROXANE
50MG/5ML
HYDROCHLOROTHIAZIDE INTENSOL
ROXANE
100MG/ML
TABLET; ORAL
ESIDRIX
NOVARTIS
25MG
50MG
100MG
HYDROCHLOROTHIAZIDE
ABC HOLDING
50MG
ACTAVIS ELIZABETH
25MG
50MG
ALRA
25MG
50MG
ASCOT
25MG
50MG
BARR
50MG
DAVA PHARMS INC
100MG
ELKINS SINN
50MG
HEATHER
50MG
IMPAX LABS
25MG
50MG
100MG
INWOOD LABS
25MG
25MG
50MG
IVAX SUB TEVA PHARMS 50MG
100MG

Feb 03, 1982

Feb 03, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 168 (of 346)

HYDROCHLOROTHIAZIDE
TABLET; ORAL
HYDROCHLOROTHIAZIDE
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

HYDRO-D
HALSEY
HYDRODIURIL
MERCK

ORETIC
ABBOTT
ZIDE
SOLVAY

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
50MG
50MG
50MG
50MG
50MG
100MG
100MG
100MG
25MG
25MG
50MG
100MG

A086192
A086192
A083972
A083972
A083972
A084880
A085112
A086597
A085004
A084536
A085005
A083899
A087565
A084912
A085219
A085323
A088827
A088828
A088829
A088924
A088923
A085683
A083965
A087827
A087752
A087638
A087610
A087586
A087587
A083458
A085232
A083232
A083456
A085233
A086087
A086594
A081190
A085099
A087002
A084899
A083809
A083809
A085347

001
002
001
002
003
001
001
001
001
002
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001
002
001
001

25MG
50MG

A086504
A083891

001
002

25MG
50MG
100MG

N011835
N011835
N011835

003
006
007

25MG

N011971

001

50MG

A083925

001

N020758
N020758

001
004

Mar 09, 1982

Dec
Dec
Dec
Feb
Feb

28,
28,
28,
07,
07,

1984
1984
1984
1985
1985

Apr 19, 1982

Apr 19, 1982

May 03, 1982

May 03, 1982

Jan 24, 1992

HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET; ORAL
AVALIDE
SANOFI AVENTIS

12.5MG;75MG
25MG;300MG

Sep 30, 1997

Mar 15, 2005

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 169 (of 346)

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

TABLET; ORAL
NORMOZIDE
SCHERING

TRANDATE HCT
GLAXOSMITHKLINE

25MG;100MG
25MG;200MG
25MG;300MG
25MG;400MG

N019046
N019046
N019046
N019046

001
002
003
004

Apr
Apr
Apr
Apr

06,
06,
06,
06,

1987
1987
1987
1987

25MG;100MG
25MG;200MG
25MG;300MG
25MG;400MG

N019174
N019174
N019174
N019174

001
002
003
004

Apr
Apr
Apr
Apr

10,
10,
10,
10,

1987
1987
1987
1987

A075926
A075926
A075926
A075869
A075869
A075869

001
002
003
001
002
003

Jul
Jul
Jul
Jul
Jul
Jul

01,
01,
01,
01,
01,
01,

2002
2002
2002
2002
2002
2002

N019778

002

Feb 16, 1989

N013402

001

N013402

002

N013402

003

N013402

004

A072507
A072508
A072509
A072510
A071458
A071459
A071460
A071461
A070616
A070612
A070613
A070614
A071897
A071898
A071899
A071900
A070853
A070688
A070854
A070689
A070182
A070829
A070183
A070830
A070543
A070544
A071819

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET; ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
SANDOZ
12.5MG;10MG
12.5MG;20MG
25MG;20MG
TEVA
12.5MG;10MG
12.5MG;20MG
25MG;20MG
PRINZIDE
MERCK
25MG;20MG

HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET; ORAL
ALDORIL 15
MERCK
15MG;250MG
ALDORIL 25
MERCK
25MG;250MG
ALDORIL D30
MERCK
30MG;500MG
ALDORIL D50
MERCK
50MG;500MG
METHYLDOPA AND HYDROCHLOROTHIAZIDE
CLONMEL HLTHCARE
15MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
IVAX SUB TEVA PHARMS 15MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
PAR PHARM
15MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
PARKE DAVIS
15MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
PUREPAC PHARM
15MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
SANDOZ
15MG;250MG
15MG;250MG
25MG;250MG
25MG;250MG
30MG;500MG
50MG;500MG
TEVA
15MG;250MG

Jun
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Feb
Feb
Feb
Feb
Nov
Nov
Nov
Nov
Oct
Apr
Oct
Apr
Jan
Mar
Jan
Mar
Jan
Jan
Apr

02,
02,
02,
02,
08,
08,
08,
08,
02,
02,
02,
02,
23,
23,
23,
23,
08,
24,
08,
24,
15,
09,
15,
09,
15,
15,
08,

1989
1989
1989
1989
1988
1988
1988
1988
1987
1987
1987
1987
1987
1987
1987
1987
1986
1986
1986
1986
1986
1987
1986
1987
1986
1986
1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 170 (of 346)

HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET; ORAL
METHYLDOPA AND HYDROCHLOROTHIAZIDE
TEVA
25MG;250MG
30MG;500MG
50MG;500MG
WATSON LABS
15MG;250MG
15MG;250MG
15MG;250MG
25MG;250MG
25MG;250MG
25MG;250MG
30MG;500MG
30MG;500MG
30MG;500MG
50MG;500MG
50MG;500MG
50MG;500MG

A071820
A071821
A071822
A070365
A070958
A071920
A070366
A070959
A071921
A070367
A071069
A071922
A070368
A070960
A071923

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Apr
Apr
Apr
Mar
Feb
Aug
Apr
Jan
Aug
Mar
Jan
Aug
Apr
Feb
Aug

08,
08,
08,
19,
06,
29,
16,
19,
29,
19,
19,
29,
16,
06,
29,

1988
1988
1988
1986
1989
1988
1986
1989
1988
1986
1989
1988
1986
1989
1988

N021956
N021956
N021956

001
002
003

Aug 28, 2006

Aug 28, 2006
Aug 28, 2006

N018303

003

Dec 31, 1984

N018872
N018872

001
002

Jul 22, 1987

Jul 22, 1987

N019059

002

Jul 03, 1985

N019059

003

Jul 03, 1985

N019059

001

Jul 03, 1985

N018031

002

A071126
A071127

001
001

Mar 02, 1987

Mar 02, 1987

A070851
A070852
A070704
A070705
A071552
A071553
A071060
A071061
A071771
A071772
A071498

001
001
001
001
001
001
001
001
001
001
001

May
May
Oct
Oct
Dec
Dec
Aug
Aug
Jan
Jan
Dec

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
NOVARTIS

50MG;100MG

HYDROCHLOROTHIAZIDE; PINDOLOL
TABLET; ORAL
VISKAZIDE
NOVARTIS

25MG;5MG
25MG;10MG

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL
INDERIDE LA 120/50
WYETH AYERST
50MG;120MG
INDERIDE LA 160/50
WYETH AYERST
50MG;160MG
INDERIDE LA 80/50
WYETH AYERST
50MG;80MG
TABLET; ORAL
INDERIDE-80/25
AKRIMAX PHARMS
25MG;80MG
PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE
DURAMED PHARMS BARR
25MG;40MG
25MG;80MG
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ACTAVIS ELIZABETH
25MG;40MG
25MG;80MG
BARR
25MG;40MG
25MG;80MG
IVAX SUB TEVA PHARMS 25MG;40MG
25MG;80MG
SANDOZ
25MG;40MG
25MG;80MG
WARNER CHILCOTT
25MG;40MG
25MG;80MG
WATSON LABS
25MG;40MG

15,
15,
01,
01,
01,
01,
26,
26,
26,
26,
18,

1986
1986
1986
1986
1988
1988
1987
1987
1988
1988
1991

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 171 (of 346)

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

TABLET; ORAL
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
WATSON LABS
25MG;80MG

A071501

001

Dec 18, 1991

A085338

001

A083572
A083571
A083568
A083573
A085421
A085420
A084603
A084466
A085317
A086330
A083666
A084467
A086331

001
001
001
001
001
001
001
001
001
002
001
001
001

N011958

002

N011958

003

A084714

002

A084827

001

A085213

001

A084580
A084579
A088200

001
001
001

Jan 31, 1984

A088189

001

May 10, 1984

N011878

003

N011878

005

A088025
A087267
A087999
A086881
A089137

001
001
001
001
001

Nov 23, 1984

A087004
A087511
A087948
A088054
A087553
A087651
A087655
A085974
A086026

002
001
001
001
001
001
001
001
001

May 24, 1982

HYDROCHLOROTHIAZIDE; RESERPINE
TABLET; ORAL
H.R.-50
WHITEWORTH TOWN PLSN 50MG;0.125MG
HYDROCHLOROTHIAZIDE W/ RESERPINE
IVAX SUB TEVA PHARMS 25MG;0.1MG
25MG;0.125MG
50MG;0.1MG
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
HYDRO-RESERP
ABC HOLDING
50MG;0.125MG
HYDRO-SERP "25"
SANDOZ
25MG;0.125MG
HYDRO-SERP "50"
SANDOZ
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

Jun 29, 1982

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
25MG;25MG
LEDERLE
25MG;25MG
PARKE DAVIS
25MG;25MG
PUREPAC PHARM
25MG;25MG
UPSHER SMITH
25MG;25MG
USL PHARMA
25MG;25MG
VANGARD
25MG;25MG
WATSON LABS
25MG;25MG
25MG;25MG

Nov 06, 1985

Aug 26, 1985

Feb 22, 1983

Aug 18, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 172 (of 346)

HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE

TABLET; ORAL
TIMOLIDE 10-25
MERCK

25MG;10MG

N018061

001

N016042

002

A074970
A074857
A071737

001
001
001

Jan 06, 1998

Sep 09, 1997
Feb 12, 1988

A072022
A071980

001
001

Apr 17, 1988

Apr 17, 1988

5MG/5ML;25MG/5ML

A075103

001

Sep 29, 2000

5MG/5ML;25MG/5ML

N019410

001

Aug 17, 1990

2.5MG/5ML;12.5MG/5ML

N019411

001

Aug 17, 1990

0.5%

N010554

001

0.5%

A085805

001

0.5%
1%

N009585
N009585

003
001

1%

A083011

002

1%
2.5%

A080459
A084055

001
001

0.5%
1%
2.5%

A087136
A087136
A087136

003
002
001

0.5%

A080438

001

1%

A080438

002

0.5%
1%

A080482
A080482

003
004

0.5%

A086823

001

2.5%

A080483

001

2.5%
0.5%

A089754
A080848

001
002

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

HYDROCODONE BITARTRATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

SYRUP; ORAL
CODAMINE
ALPHARMA US PHARMS
HYCOMINE
ENDO PHARMS
HYCOMINE PEDIATRIC
ENDO PHARMS

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

HC #1
BAYER PHARMS
HC #4
BAYER PHARMS
HC (HYDROCORTISONE)
C AND M PHARMA
H-CORT
PHARM ASSOC
HI-COR
C AND M PHARMA
HYDROCORTISONE
ALPHARMA US PHARMS
ALTANA

Apr 08, 1982

Apr 08, 1982
Apr 08, 1982

Feb 01, 1989

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DISCONTINUED DRUG PRODUCT LIST

6 - 173 (of 346)

HYDROCORTISONE
CREAM; TOPICAL
HYDROCORTISONE
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
SANOFI AVENTIS US
NOGENIC HC
IVAX PHARMS
NUTRACORT
CORIA
PENECORT
ALLERGAN HERBERT
PROCTOCORT
MONARCH PHARMS
SYNACORT
MEDICIS
GEL; TOPICAL
NUTRACORT
HEALTHPOINT
PENECORT
ALLERGAN HERBERT
INJECTABLE; INJECTION
CORTEF
PHARMACIA AND UPJOHN
LOTION; TOPICAL
ACTICORT
BAKER NORTON
BALNEOL-HC
SOLVAY
BETA-HC
BETA DERMAC
CETACORT
CORIA
CORT-DOME
BAYER PHARMS

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%

A080848
A086080
A086271
A080452
A080452
A084059
A080456
A080456
A085733
A089706
A084970
A085026
A088845
A089413
A087838
A086170
A085527
A086154
A080400
A080400
A085191
A080400
A089273
A088027
A088029
A080496

003
001
001
001
002
001
002
003
001
001
002
001
001
001
001
001
001
001
002
003
001
004
001
001
001
002

1%
2.5%

A080472
A080472

003
004

1%

A087427

001

0.5%
1%

A080442
A080442

002
003

1%

A088216

001

1%

A083011

001

0.5%

A087459

001

1%

A084698

001

1%

A088215

001

50MG/ML

N009864

001

1%

A086535

001

1%

A088041

001

Dec 03, 1982

1%

A089495

001

Jan 25, 1988

0.5%
1%

A080426
A080426

002
001

0.5%
1%

N009895
N009895

003
001

Mar 10, 1988

Feb 27, 1986

Dec 16, 1986
Jul 28, 1982

Feb 17, 1989

Sep 27, 1983
Sep 27, 1983

Apr 04, 1988

Jun 06, 1984

Jun 06, 1984

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DISCONTINUED DRUG PRODUCT LIST

6 - 174 (of 346)

HYDROCORTISONE
LOTION; TOPICAL
DERMACORT
SOLVAY
EPICORT
BLULINE
GLYCORT
HERAN
H-CORT
PHARM ASSOC
HYDROCORTISONE
ALPHARMA US PHARMS
MERICON
NASKA
PERRIGO NEW YORK
TARO
HYTONE
SANOFI AVENTIS US
NUTRACORT
CORIA
OINTMENT; TOPICAL
CORTRIL
PFIZER GLOBAL
HC (HYDROCORTISONE)
C AND M PHARMA
HYDROCORTISONE
ALTANA
AMBIX
NASKA
PERRIGO NEW YORK
PHARMADERM
TARO
USL PHARMA
HYTONE
DERMIK LABS

0.5%
1%

A084573
A086462

002
001

0.5%

A083219

002

1%

A087489

001

0.5%

A086824

001

0.5%
1%
0.5%
1%
1%
0.5%
1%
1%

A087317
A087315
A085282
A085282
A089705
A085662
A085663
A089024

001
001
001
002
001
001
001
001

1%
2.5%

A080473
A080473

003
004

0.5%

A080443

002

1%
2.5%

N009176
N009176

001
002

0.5%
1%

A080481
A080481

001
002

0.5%
1%
1%
2.5%
1%
0.5%
1%
1%
0.5%
1%
2.5%

A080489
A080489
A086079
A086272
A089704
A084969
A085028
A088842
A086256
A088061
A088039

002
003
001
001
001
003
001
001
001
001
001

1%
2.5%

A080474
A080474

003
004

A088217

001

Jun 06, 1984

A087834

001

Mar 29, 1982

A088082

001

Apr 08, 1983

A088214

001

Jun 06, 1984

A080425

001

N009127
N009127

005
003

PENECORT
ALLERGAN HERBERT
2.5%
POWDER; FOR RX COMPOUNDING
H-CORT
TORCH
100%
HYDROCORTISONE
PADDOCK LLC
100%
SOLUTION; TOPICAL
PENECORT
ALLERGAN HERBERT
1%
TEXACORT
MISSION PHARMA
1%
TABLET; ORAL
CORTRIL
PFIZER
10MG
20MG

Oct 03, 1983

Jun 07, 1982

Jun 07, 1982
Feb 26, 1987
Apr 25, 1988

Feb 12, 1986

Nov 30, 1982

Mar 10, 1988

Feb 09, 1987

Sep 27, 1983
Sep 27, 1983

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DISCONTINUED DRUG PRODUCT LIST

6 - 175 (of 346)

HYDROCORTISONE
TABLET; ORAL
HYDROCORTISONE
BARR
ELKINS SINN
FERRANTE
IMPAX LABS
INWOOD LABS
LANNETT
NEXGEN PHARMA INC
PANRAY
PARKE DAVIS
PUREPAC PHARM

ROXANE
SANDOZ
WATSON LABS
WHITEWORTH TOWN PLSN
HYDROCORTONE
MERCK
TABLET; VAGINAL
CORTRIL
PFIPHARMECS

20MG
20MG
10MG
20MG
20MG
20MG
20MG
20MG
10MG
20MG
20MG
10MG
20MG
20MG
10MG
20MG
20MG
10MG
20MG

A083999
A080624
A080568
A080568
A080781
A080732
A085070
A083140
N009659
N009659
A084243
A084247
A080395
A084247
A088539
A080642
A080355
A080344
A080344

001
001
001
002
001
001
001
001
001
002
001
003
001
002
001
002
001
001
002

10MG
20MG

N008506
N008506

007
011

10MG

N009796

001

1%

A081274

001

Jun 19, 1992

1%
1%
0.5%
1%

A080419
A089914
A086050
A086052

001
001
001
001

Jan 25, 1982

Jan 03, 1989

50MG/ML

N009378

002

25MG/ML

N009164

001

25MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG/ML
25MG/ML
50MG/ML
50MG/ML

N009637
N009637
A083739
A083739
A083128
A083759
A083759
A085214

001
002
001
002
001
001
002
001

25MG/ML
50MG/ML

N008228
N008228

001
004

A086207

001

A080828

001

N009018

003

Aug 31, 1982

Mar 21, 1984

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

HYDROCORTONE
MERCK

LOTION; TOPICAL
DRICORT
INGRAM PHARM
0.5%
OINTMENT; OPHTHALMIC
HYDROCORTISONE ACETATE
FERA PHARMS
0.5%
OINTMENT; OPHTHALMIC, OTIC
HYDROCORTONE
MERCK
1.5%

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6 - 176 (of 346)

HYDROCORTISONE ACETATE
OINTMENT; TOPICAL
CORTEF ACETATE
PHARMACIA AND UPJOHN

1%
2.5%

N008917
N008917

002
001

1%;EQ 3.5MG BASE/GM

2.5%;EQ 3.5MG BASE/GM

A061049
A061049

001
002

0.5%;EQ 3.5MG BASE/GM

1.5%;EQ 3.5MG BASE/GM

A060610
A060610

001
002

0.5%;EQ 3.5MG BASE/GM

1%;EQ 3.5MG BASE/GM
2.5%;EQ 3.5MG BASE/GM
SUSPENSION/DROPS; OPHTHALMIC
COR-OTICIN
AKORN
1.5%;EQ 3.5MG BASE/ML
NEO-CORTEF
PHARMACIA AND UPJOHN 0.5%;EQ 3.5MG BASE/ML
1.5%;EQ 3.5MG BASE/ML

A060751
A060751
A060751

001
002
003

A060188

001

A060612
A060612

002
001

A061016

001

A089440

001

A083213

002

0.1%

N018795

001

Jan 07, 1983

0.1%

N019106

001

Jul 03, 1984

0.1%

N019819

001

Sep 15, 1988

EQ 10MG BASE/5ML

N009900

001

N012052

001

HYDROCORTISONE ACETATE; NEOMYCIN SULFATE

CREAM; TOPICAL
NEO-CORTEF
PHARMACIA AND UPJOHN
OINTMENT; OPHTHALMIC
NEO-CORTEF
PHARMACIA AND UPJOHN
OINTMENT; TOPICAL
NEO-CORTEF
PHARMACIA AND UPJOHN

HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE

SUSPENSION; OPHTHALMIC
TERRA-CORTRIL
PFIZER

1.5%;EQ 5MG BASE/ML

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

AEROSOL, METERED; TOPICAL
HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%
BOCA PHARMA
1%;1%
LOTION; TOPICAL
PRAMOSONE
FERNDALE LABS
0.5%;1%

May 17, 1988

HYDROCORTISONE BUTYRATE
CREAM; TOPICAL
LOCOID
YAMANOUCHI
OINTMENT; TOPICAL
LOCOID
YAMANOUCHI
SOLUTION; TOPICAL
LOCOID
YAMANOUCHI

HYDROCORTISONE CYPIONATE
SUSPENSION; ORAL
CORTEF
PHARMACIA AND UPJOHN

HYDROCORTISONE SODIUM PHOSPHATE

INJECTABLE; INJECTION
HYDROCORTONE
MERCK

EQ 50MG BASE/ML

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6 - 177 (of 346)

HYDROCORTISONE SODIUM SUCCINATE

INJECTABLE; INJECTION
A-HYDROCORT
ABBOTT

EQ 100MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
HOSPIRA
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
HYDROCORTISONE SODIUM SUCCINATE
ABRAXIS PHARM
EQ 100MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
BAXTER HLTHCARE
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
INTL MEDICATION
EQ 100MG BASE/VIAL
WATSON LABS
EQ 100MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL

A085928
A089577
A089578
A089579
A089580
A085929
A085930
A085931
A085932

001
001
001
001
001
001
001
001
001

A088667
A088712
A088668
A088669
A088670
A086619
A087567
A087568
A087569
A087532
A084737
A084738
A084737
A084747
A084748

Apr
Apr
Apr
Apr

11,
11,
11,
11,

1989
1989
1989
1989

001
001
001
001
001
001
001
001
001
001
002
001
001
001
001

Jun
Jun
Jun
Jun
Jun

08,
08,
08,
08,
08,

1984
1984
1984
1984
1984

A074489

001

Aug 12, 1998

N050237
N050237

006
005

Jun 05, 1984

Jun 05, 1984

A062394

001

Sep 29, 1982

A060730

002

N050169

001

A062623

001

Sep 24, 1985

A062617

001

Sep 18, 1985

A062399

001

Nov 18, 1982

A061816

001

A062521

001

Mar 19, 1982

HYDROCORTISONE VALERATE
CREAM; TOPICAL
HYDROCORTISONE VALERATE
TEVA PHARMS
0.2%

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
PHARMAFAIR
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
OTOCORT
WATSON LABS
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
SUSPENSION/DROPS; OPHTHALMIC
CORTISPORIN
MONARCH PHARMS
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE
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
OTICAIR
PHARMAFAIR
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
OTOBIONE
SCHERING
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
OTOCORT
WATSON LABS
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Jul 11, 1985

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6 - 178 (of 346)

HYDROCORTISONE; POLYMYXIN B SULFATE

SOLUTION/DROPS; OTIC
OTOBIOTIC
SCHERING
PYOCIDIN
FOREST LABS

5MG/ML;EQ 10,000 UNITS BASE/ML

A062302

001

5MG/ML;EQ 10,000 UNITS BASE/ML

A061606

001

1.5%;1%

N050272

001

1%;10%

A086008

001

1%;10%

A083947

001

50MG

A083383

001

50MG
50MG
50MG

A088850
A088031
A088528

001
001
001

May 31, 1985

Apr 06, 1983
Aug 15, 1984

A088195
A088127
A088110

001
001
001

Oct 26, 1983

Mar 22, 1983
Mar 22, 1983

A088932
A088907

001
001

Jan 11, 1985

Sep 20, 1985

N012359

003

N012359

004

N021044
N021044
N021044
N021044

001
002
003
004

Sep
Sep
Sep
Sep

A074317

001

Aug 23, 1995

1MG/ML

A080778

001

2.5GM/VIAL (5GM/KIT)

N022041

002

1MG/ML
1MG/ML

A084921
A085528

001
001

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
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
12MG
16MG
24MG
32MG
INJECTABLE; INJECTION
HYDROMORPHONE HYDROCHLORIDE
WATSON LABS
10MG/ML

24,
24,
24,
24,

2004
2004
2004
2004

HYDROXOCOBALAMIN
INJECTABLE; INJECTION
ALPHAREDISOL
MERCK
CYANOKIT
MERCK SANTE SAS
HYDROXOCOBALAMIN
ABRAXIS PHARM
WATSON LABS

Dec 15, 2006

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DISCONTINUED DRUG PRODUCT LIST

6 - 179 (of 346)

HYDROXOCOBALAMIN
INJECTABLE; INJECTION
HYDROXOMIN
BEL MAR

1MG/ML

A084629

001

N000004

004

N010347
N016911
N010347
N016911

004
001
002
002

N018004
N017439
N017439

001
001
002

N009166

001

250MG
250MG
500MG
500MG

A075143
A075020
A075020
A074476

002
002
001
001

Sep
Jun
Jul
Aug

1GM

A075734

001

Aug 29, 2000

A085551

002

A087273
A087273
A088184
A088185
A085551
A087416
A086821
A087546
A088862
A089106
A088881
A089107
A087592
A086822
A087591
A087310
A087593
A087595
A087596
A085778

001
002
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

HYDROXYAMPHETAMINE HYDROBROMIDE
SOLUTION/DROPS; OPHTHALMIC
PAREDRINE
PHARMICS
1%

HYDROXYPROGESTERONE CAPROATE
INJECTABLE; INJECTION
DELALUTIN
BRISTOL MYERS SQUIBB

125MG/ML
125MG/ML
250MG/ML
250MG/ML
HYDROXYPROGESTERONE CAPROATE
AKORN
125MG/ML
WATSON LABS
125MG/ML
250MG/ML

HYDROXYSTILBAMIDINE ISETHIONATE
INJECTABLE; INJECTION
HYDROXYSTILBAMIDINE ISETHIONATE
SANOFI AVENTIS US
225MG/AMP

HYDROXYUREA
CAPSULE; ORAL
HYDROXYUREA
BARR
DURAMED PHARMS BARR
ROXANE
TABLET; ORAL
HYDROXYUREA
BARR

21,
26,
30,
18,

2000
2000
1998
1995

HYDROXYZINE HYDROCHLORIDE
INJECTABLE; INJECTION
HYDROXYZINE
BAXTER HLTHCARE
50MG/ML
HYDROXYZINE HYDROCHLORIDE
ALTANA
25MG/ML
50MG/ML
APP PHARMS
25MG/ML
50MG/ML
BAXTER HLTHCARE
25MG/ML
HOSPIRA
25MG/ML
50MG/ML
50MG/ML
PHARMAFAIR
25MG/ML
25MG/ML
50MG/ML
50MG/ML
SMITH AND NEPHEW
25MG/ML
SOLOPAK
25MG/ML
25MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
WATSON LABS
25MG/ML

Apr
Apr
Mar
Mar

20,
20,
31,
31,

1982
1982
1983
1983

Feb
Feb
Feb
Feb

14,
14,
14,
14,

1986
1986
1986
1986

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DISCONTINUED DRUG PRODUCT LIST

6 - 180 (of 346)

HYDROXYZINE HYDROCHLORIDE
INJECTABLE; INJECTION
HYDROXYZINE HYDROCHLORIDE
WATSON LABS
25MG/ML
50MG/ML
50MG/ML
WYETH AYERST
25MG/ML
50MG/ML
ORGATRAX
ORGANON USA INC
25MG/ML
50MG/ML
VISTARIL
PFIZER
25MG/ML
50MG/ML
SYRUP; ORAL
ATARAX
ROERIG
10MG/5ML
HYDROXYZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 10MG/5ML
ALPHARMA US PHARMS
10MG/5ML
KV PHARM
10MG/5ML
TABLET; ORAL
ATARAX
PFIZER
10MG
25MG
50MG
100MG
HYDROXYZINE HYDROCHLORIDE
ABLE
10MG
25MG
50MG
ACTAVIS TOTOWA
10MG
10MG
25MG
25MG
50MG
50MG
HALSEY
10MG
25MG
50MG
IVAX PHARMS
10MG
25MG
50MG
KV PHARM
10MG
25MG
50MG
100MG
MUTUAL PHARM
10MG
25MG
50MG
100MG
PLIVA
100MG
PUREPAC PHARM
10MG
25MG
50MG
QUANTUM PHARMICS
10MG
25MG
50MG
SANDOZ
10MG
10MG
25MG
25MG
50MG
50MG

A087274
A085779
A087274
A086258
A086258

001
001
002
001
002

A087014
A087014

001
002

N011111
N011111

001
002

N010485

001

A086880
A088785
A087730

001
001
001

N010392
N010392
N010392
N010392

001
004
006
005

A040559
A040562
A040563
A040600
A089071
A040602
A089072
A040604
A089073
A089366
A089117
A089396
A087216
A087410
A087411
A087819
A087820
A087821
A087822
A088409
A087857
A087860
A087862
A081054
A088120
A088121
A088122
A088540
A088551
A088529
A087246
A087869
A085247
A087870
A087245
A087871

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001

Feb 03, 1988

Jul 01, 1982

Jul
Jul
Jul
Dec
Jul
Dec
Jul
Dec
Jul
May
May
May

22,
22,
22,
28,
22,
28,
22,
28,
22,
02,
02,
02,

2004
2004
2004
2004
1986
2004
1986
2004
1986
1988
1988
1988

Jun
Jun
Jun
Jun
Nov
Apr
Apr
Apr
Sep
Sep
Sep
Sep
Oct
Oct
Oct

23,
23,
23,
23,
15,
18,
18,
18,
25,
25,
25,
25,
22,
22,
22,

1982
1982
1982
1982
1983
1983
1983
1983
1995
1984
1984
1984
1985
1985
1985

Dec 20, 1982

Dec 20, 1982
Dec 20, 1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 181 (of 346)

HYDROXYZINE HYDROCHLORIDE
TABLET; ORAL
HYDROXYZINE HYDROCHLORIDE
SUPERPHARM
10MG
25MG
50MG
USL PHARMA
10MG
25MG
50MG
VINTAGE
10MG
25MG
50MG
WATSON LABS
10MG
25MG
50MG

A088794
A088795
A088796
A089121
A089122
A089123
A087602
A087603
A087604
A086827
A086829
A086836

001
001
001
001
001
001
001
001
001
001
001
001

Dec
Dec
Dec
Mar
Mar
Mar
Jan
Jan
Jan

05,
05,
05,
20,
20,
20,
22,
22,
22,

1984
1984
1984
1986
1986
1986
1982
1982
1982

A088593
A088594
A088595
A087761
A087760
A087656
A089145
A087657
A089146
A087658
A081127
A081128
A081129
A089031
A089032
A089033
A088392
A088393
A086698
A086840
A086695
A086705
A087767
A086697
A086728
A087790

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Feb
Feb
Feb
Mar
Mar
Jun
Mar
Jun
Mar
Jun
Jun
Jun
Jun
Jan
Jan
Jan
Sep
Sep

29,
29,
29,
05,
05,
11,
17,
11,
17,
11,
28,
28,
28,
02,
02,
02,
19,
19,

1984
1984
1984
1982
1982
1982
1986
1982
1986
1982
1991
1991
1991
1987
1987
1987
1983
1983

EQ 25MG HCL

A088713

001

Mar 04, 1985

EQ 100MG HCL

N011459

006

EQ 2.5MG BASE

N021455

001

May 16, 2003

200MG
200MG

A070626
A071002

001
001

Sep 02, 1987

Sep 02, 1987

100MG/5ML

N019833

002

Sep 19, 1989

HYDROXYZINE PAMOATE
CAPSULE; ORAL
HYDROXYZINE PAMOATE
DURAMED PHARMS BARR

IVAX SUB TEVA PHARMS

PAR PHARM

SANDOZ

SUPERPHARM

VANGARD
WATSON LABS

HY-PAM "25"
TEVA
VISTARIL
PFIZER

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

25MG HCL
50MG HCL
100MG HCL
25MG HCL
50MG HCL
25MG HCL
25MG HCL
50MG HCL
50MG HCL
100MG HCL
25MG HCL
50MG HCL
100MG HCL
25MG HCL
50MG HCL
100MG HCL
25MG HCL
50MG HCL
25MG HCL
25MG HCL
50MG HCL
50MG HCL
50MG HCL
100MG HCL
100MG HCL
100MG HCL

Jul 01, 1982

Jul 01, 1982
Aug 16, 1982
Oct 05, 1982
Aug 16, 1982

IBANDRONATE SODIUM
TABLET; ORAL
BONIVA
ROCHE

IBUPROFEN
CAPSULE; ORAL
MIDOL
BAYER
SUSPENSION; ORAL
CHILDREN'S ADVIL
WYETH CONS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 182 (of 346)

IBUPROFEN
SUSPENSION; ORAL
IBU
ABBOTT
MOTRIN
MCNEIL CONSUMER
SUSPENSION/DROPS; ORAL
MOTRIN
MCNEIL
TABLET; ORAL
ACHES-N-PAIN
LEDERLE
CAP-PROFEN
PERRIGO
IBU
BASF

IBUPRIN
PLIVA
IBUPROFEN
ABBOTT
HALSEY

IVAX SUB TEVA PHARMS

LEDERLE
LEINER
MCNEIL
MUTUAL PHARM

MYLAN

PAR PHARM

PERRIGO
PLIVA

PUREPAC PHARM

100MG/5ML

N019784

001

Dec 18, 1989

100MG/5ML

N019842

001

Sep 19, 1989

40MG/ML

N020476

001

May 25, 1995

200MG

A071065

001

May 28, 1987

200MG

A072097

001

Dec 08, 1987

400MG
400MG
600MG
600MG
800MG

A070083
N018197
A070088
A070099
A070745

001
001
001
001
001

Feb 22, 1985

200MG

A071773

001

Jul 16, 1987

600MG
800MG
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
200MG
300MG
400MG
600MG
800MG
200MG
400MG
600MG
800MG
200MG
200MG

A070556
A071264
A071027
A071028
A071029
A071030
A072137
A071144
A071154
A072040
A072901
A072903
A071145
A071146
A071769
A070629
A070630
A071266
A070081
A070476
A070493
A070908
A071462
A070079
A070080
A071448
A071870
A070045
A070057
A071999
A071575
A070328
A070329
A070330
A070986
A072098
A071666
A071667
A071668
A071122
A071664

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jul
Sep
Mar
Mar
Mar
Feb
Jan
Oct
Apr
Dec
Dec
Sep
Sep
May
Sep
Sep
Oct
Jun
Jun
Dec
Sep
Oct
Jul
Jul
Feb
May
Sep
Sep
Dec
May
Aug
Aug
Aug
Jul
Dec
Jun
Jun
Jun
Oct
Feb

Feb 08, 1985

Mar 29, 1985
Jul 23, 1986

14,
25,
29,
23,
23,
23,
05,
20,
27,
29,
19,
19,
23,
23,
08,
19,
19,
15,
16,
16,
24,
26,
02,
24,
24,
18,
05,
24,
24,
03,
08,
06,
06,
06,
25,
08,
18,
18,
18,
03,
03,

1985
1986
1987
1987
1987
1987
1988
1987
1987
1988
1991
1991
1986
1986
1987
1986
1986
1986
1986
1986
1985
1986
1986
1985
1985
1987
1988
1985
1985
1987
1987
1985
1985
1985
1986
1987
1987
1987
1987
1986
1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 183 (of 346)

IBUPROFEN
TABLET; ORAL
IBUPROFEN
PUREPAC PHARM

SANDOZ

SUPERPHARM
TEVA

VINTAGE PHARMS
WATSON LABS

IBUPROHM
OHM LABS
IBU-TAB
ALRA
MEDIPREN
MCNEIL
MIDOL
BAYER
MOTRIN
MCNEIL CONSUMER

MCNEIL PED
NUPRIN
BRISTOL MYERS
MCNEIL
RUFEN
BASF
TABLET, CHEWABLE; ORAL
MOTRIN
MCNEIL PED

300MG
400MG
600MG
800MG
200MG
200MG
200MG
200MG
300MG
400MG
400MG
600MG
600MG
800MG
800MG
600MG
200MG
400MG
600MG
800MG
200MG
200MG
200MG
300MG
400MG
600MG
800MG
800MG

A071123
A071124
A071125
A071964
A070733
A071807
A074525
A074533
A070734
A070735
A072064
A070736
A072065
A071938
A072169
A070709
A073141
A073343
A073344
A073345
A072249
A071765
A071905
A071338
A070038
A070041
A071547
A071911

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Sep
Sep
Sep
Feb
Sep
Feb
Dec
Dec
Jun
Jun
Jan
Jun
Jan
Jan
Dec
Apr
May
Jun
Jun
Jun
Jan
Sep
Mar
Dec
Sep
Sep
Jul
Oct

19,
19,
19,
01,
19,
25,
15,
15,
12,
12,
14,
12,
14,
14,
11,
25,
29,
30,
30,
30,
10,
04,
08,
01,
06,
06,
02,
13,

400MG

A070469

001

Aug 29, 1985

800MG

A071965

001

Aug 11, 1988

200MG
200MG

A070475
A071215

001
001

Feb 06, 1986

Jun 26, 1986

200MG
200MG

A070591
A071001

001
001

Sep 02, 1987

Sep 02, 1987

300MG
400MG
600MG
800MG
100MG

N017463
N017463
N017463
N017463
N020418

003
002
004
005
001

May 22, 1985

Nov 16, 1994

200MG
200MG
200MG
200MG

A072035
A072036
N019012
N019012

001
001
001
002

Feb
Feb
May
Jul

600MG

N018197

002

Mar 05, 1984

50MG
100MG

N020135
N020135

001
002

Nov 16, 1994

Nov 16, 1994

N021378

001

Nov 26, 2004

16,
16,
18,
29,

1986
1986
1986
1988
1986
1988
1995
1995
1986
1986
1988
1986
1988
1988
1987
1986
1992
1992
1992
1992
1989
1987
1988
1986
1985
1985
1987
1987

1988
1988
1984
1987

IBUPROFEN; OXYCODONE HYDROCHLORIDE

TABLET; ORAL
COMBUNOX
FOREST LABS

400MG;5MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 184 (of 346)

IDARUBICIN HYDROCHLORIDE
INJECTABLE; INJECTION
IDAMYCIN
PHARMACIA AND UPJOHN

5MG/VIAL
10MG/VIAL
20MG/VIAL

N050661
N050661
N050661

002
001
003

Sep 27, 1990

Sep 27, 1990
Apr 25, 1995

N015868

001

N013934

001

1GM/VIAL;100MG/ML
3GM/VIAL;100MG/ML

N019763
N019763

003
004

Oct 10, 1992

Oct 10, 1992

20MCG/2ML (10MCG/ML)

N021779

001

Dec 29, 2004

EQ 50MG BASE
EQ 100MG BASE

N021335
N021335

001
002

May 10, 2001

May 10, 2001

A086765

001

N011838

002

A040753
A040752
A040751
A086269
A086267
A086268
A089497
A088276
A083799
A083799
A083799
A085200
A084869
A085133
A083729
A083729
A083729
A087776
A088036
A087619
A087631
A085220

001
001
001
001
001
001
001
001
001
002
003
001
002
001
001
004
003
001
001
001
001
001

IDOXURIDINE
OINTMENT; OPHTHALMIC
STOXIL
GLAXOSMITHKLINE
0.5%
SOLUTION/DROPS; OPHTHALMIC
STOXIL
GLAXOSMITHKLINE
0.1%

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
25MG/ML
INJECTABLE; INJECTION
TOFRANIL
NOVARTIS
12.5MG/ML
TABLET; ORAL
IMIPRAMINE HYDROCHLORIDE
ACTAVIS TOTOWA
10MG
25MG
50MG
LEDERLE
10MG
25MG
50MG
PAR PHARM
25MG
50MG
ROXANE
10MG
25MG
50MG
SANDOZ
10MG
25MG
50MG
TEVA
10MG
25MG
50MG
USL PHARMA
25MG
VANGARD
10MG
25MG
50MG
WATSON LABS
10MG

Feb 28, 2008

Feb 28, 2008
Feb 28, 2008

Jul 14, 1987

Oct 21, 1983

Feb
Nov
Feb
Jan

10,
03,
09,
04,

1982
1982
1982
1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 185 (of 346)

IMIPRAMINE HYDROCHLORIDE
TABLET; ORAL
IMIPRAMINE HYDROCHLORIDE
WATSON LABS
10MG
25MG
25MG
50MG
50MG
WEST WARD
25MG
50MG
JANIMINE
ABBOTT
10MG
25MG
50MG
PRAMINE
ALRA
10MG
25MG
50MG
PRESAMINE
SANOFI AVENTIS US
10MG
25MG
50MG

A085875
A084252
A085878
A085221
A085877
A088222
A088223

001
002
001
001
001
001
001

N017895
N017895
N017895

001
002
003

A083827
A083827
A083827

001
002
003

N011836
N011836
N011836

006
003
007

EQ 5MG BASE/ML
EQ 5MG BASE/ML

A075542
A074616

001
001

May 10, 2000

Aug 03, 1998

EQ 5MG BASE/ML

N018700

001

Jul 31, 1984

1.25MG
2.5MG
1.25MG
1.25MG
2.5MG
2.5MG

A075201
A075201
A074498
A074665
A074498
A074665

001
002
002
001
001
002

Dec
Dec
Feb
Apr
Oct
Apr

1.25MG
2.5MG

N018538
N018538

002
001

Apr 29, 1993

Jul 06, 1983

N019693
N019693
N019693

001
002
003

Dec 29, 1989

Dec 29, 1989
Dec 29, 1989

EQ 333MG BASE

N020685

005

Dec 17, 1998

10MG/VIAL
40MG/VIAL
50MG/VIAL

N011525
N011525
N011525

003
004
002

May 26, 1983

May 26, 1983

INAMRINONE LACTATE
INJECTABLE; INJECTION
AMRINONE LACTATE
BAXTER HLTHCARE CORP
HOSPIRA
INOCOR
SANOFI AVENTIS US

INDAPAMIDE
TABLET; ORAL
INDAPAMIDE
CADISTA PHARMS
TEVA

LOZOL
SANOFI AVENTIS US

04,
04,
12,
04,
31,
04,

1998
1998
1998
1997
1996
1997

INDECAINIDE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
DECABID
LILLY
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE

INDINAVIR SULFATE
CAPSULE; ORAL
CRIXIVAN
MERCK SHARP DOHME

INDOCYANINE GREEN
INJECTABLE; INJECTION
IC-GREEN
AKORN

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DISCONTINUED DRUG PRODUCT LIST

6 - 186 (of 346)

INDOMETHACIN
CAPSULE; ORAL
INDOCIN
IROKO PHARMS
INDO-LEMMON
TEVA

25MG
50MG

N016059
N016059

001
002

25MG
50MG

A070266
A070267

001
001

Nov 07, 1985

Nov 07, 1985

A076666
A076666
A070326
A070327
A070782
A070635
N018730
N018730
A070067
A070899
A070068
A070900
N018858
N018806
N018806
A070813
A070592
A071148
A071149
A070353
A070354
A070487
A070488
A071342
A071343
N018829
A070651
N018829
A070529
A070784
A072996
N018690
A070530
A070785
A071635
A072997
N018690

001
002
001
001
001
001
001
002
001
001
001
001
002
001
002
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001
001
002

Dec
Dec
Oct
Oct
Jun
Jun
May
May
Oct
Feb
Oct
Feb
Apr
Nov
Nov
Aug
Aug
Mar
Mar
Jun
Jun
Oct
Oct
Apr
Apr
Aug
Mar
Aug
Oct
Aug
Jul
Jul
Oct
Aug
May
Jul
Jul

N018185

001

Feb 23, 1982

A076114
A072410

001
001

Feb 06, 2002

Mar 15, 1989

N017814

001

Aug 13, 1984

A071412

001

Mar 18, 1987

001

Aug 26, 2008

INDOMETHACIN
ABLE

25MG
50MG
DURAMED PHARMS BARR
25MG
50MG
HALSEY
25MG
50MG
IVAX SUB TEVA PHARMS 25MG
50MG
MUTUAL PHARM
25MG
25MG
50MG
50MG
MYLAN
50MG
PARKE DAVIS
25MG
50MG
PIONEER PHARMS
25MG
50MG
PLIVA
25MG
50MG
ROXANE
25MG
50MG
SUPERPHARM
25MG
50MG
TEVA
25MG
50MG
VINTAGE
25MG
50MG
50MG
WATSON LABS
25MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG
50MG
CAPSULE, EXTENDED RELEASE; ORAL
INDOCIN SR
IROKO PHARMS
75MG
INDOMETHACIN
ABLE
75MG
INWOOD LABS
75MG
SUPPOSITORY; RECTAL
INDOCIN
IROKO PHARMS
50MG
SUSPENSION; ORAL
INDOMETHACIN
ROXANE
25MG/5ML

17,
17,
18,
18,
03,
03,
04,
04,
03,
09,
03,
09,
20,
23,
23,
11,
11,
18,
18,
18,
18,
10,
10,
18,
18,
06,
05,
06,
18,
20,
31,
31,
18,
20,
18,
31,
31,

2003
2003
1985
1985
1987
1987
1984
1984
1986
1987
1986
1987
1984
1984
1984
1986
1986
1987
1987
1985
1985
1986
1986
1988
1988
1984
1986
1984
1985
1986
1991
1984
1985
1986
1987
1991
1984

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

INJECTABLE; SUBCUTANEOUS
NOVOLOG MIX 50/50
NOVO NORDISK INC

50 UNITS/ML;50 UNITS/ML

N021810

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DISCONTINUED DRUG PRODUCT LIST

6 - 187 (of 346)

INSULIN PORK
INJECTABLE; INJECTION

ILETIN I

LILLY
INSULIN

NOVO NORDISK INC

REGULAR INSULIN

NOVO NORDISK INC

500 UNITS/ML

N017931

001

40 UNITS/ML

N017926

001

100 UNITS/ML

N017926

003

100 UNITS/ML

N018478

001

N018344

002

N018344

001

N018381

001

N018193

001

N018195

001

100 UNITS/ML

N019529

001

Apr 28, 1986

100 UNITS/ML

N021028

001

Jul 19, 1999

1MG/INH
3MG/INH

N021868
N021868

001
002

Jan 27, 2006

Jan 27, 2006

N020100

001

Apr 29, 1992

100 UNITS/ML

N018778

001

Aug 30, 1983

100 UNITS/ML

N019450

001

May 30, 1986

INSULIN PURIFIED BEEF

INJECTABLE; INJECTION

REGULAR ILETIN II

LILLY

INSULIN PURIFIED PORK

INJECTABLE; INJECTION

ILETIN II

LILLY
500 UNITS/ML
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

30 UNITS/ML;70 UNITS/ML

INSULIN RECOMBINANT HUMAN

INJECTABLE; INJECTION
HUMULIN BR
LILLY
VELOSULIN BR
NOVO NORDISK INC
POWDER; INHALATION
EXUBERA
PFIZER

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
NOVO NORDISK INC

INSULIN RECOMBINANT PURIFIED HUMAN; INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED

HUMAN
INJECTABLE; INJECTION
MIXTARD HUMAN 70/30
BAYER PHARMS
NOVOLIN 70/30
NOVO NORDISK INC

30 UNITS/ML;70 UNITS/ML

N019585

001

Mar 11, 1988

30 UNITS/ML;70 UNITS/ML

N019441

001

Jul 11, 1986

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6 - 188 (of 346)

INSULIN SUSP ISOPHANE BEEF

INJECTABLE; INJECTION
NPH INSULIN
NOVO NORDISK INC

40 UNITS/ML
100 UNITS/ML

N017929
N017929

001
003

N017936
N017936

001
002

N018479

001

N018194

001

N018345

001

N018623

001

100 UNITS/ML

N019449

001

May 30, 1986

100 UNITS/ML

N019065

001

Jan 23, 1985

N017932
N017932

001
002

N018476

001

N017928
N017928

001
003

N018346

001

N017998
N017998

001
003

N017997

003

INSULIN SUSP ISOPHANE BEEF/PORK

INJECTABLE; INJECTION
NPH ILETIN I (BEEF-PORK)
LILLY
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

INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN

INJECTABLE; INJECTION
INSULATARD NPH HUMAN
NOVO NORDISK INC
NOVOLIN N
NOVO NORDISK INC

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;
PROTAMINE
LILLY
PROTAMINE
BRISTOL

INJECTION
ZINC AND ILETIN II
100 UNITS/ML
ZINC INSULIN
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

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6 - 189 (of 346)

INSULIN ZINC SUSP EXTENDED PURIFIED BEEF

INJECTABLE; INJECTION
ULTRALENTE
NOVO NORDISK INC

N018385

001

N019571
N019571

001
002

N017996

003

N018382

001

N018477

001

N018384

001

100 UNITS/ML

N018383

001

100 UNITS/ML

N018347

001

100 UNITS/ML

N019377

002

Sep 30, 1985

100 UNITS/ML

N019965

001

Jun 25, 1991

N018777

001

Aug 30, 1983

N002282

001

N016717

001

100 UNITS/ML

INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN

INJECTABLE; INJECTION
HUMULIN U
LILLY

40 UNITS/ML
100 UNITS/ML

Jun 10, 1987

Jun 10, 1987

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
LENTE ILETIN II (PORK)
LILLY

INSULIN ZINC SUSP RECOMBINANT HUMAN

INJECTABLE; INJECTION
HUMULIN L
LILLY
NOVOLIN L
NOVO NORDISK INC

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

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DISCONTINUED DRUG PRODUCT LIST

6 - 190 (of 346)

IOBENGUANE SULFATE I-131

INJECTABLE; INJECTION
IOBENGUANE SULFATE I 131
PHARMALUCENCE
2.3mCi/ML

N020084

001

Mar 25, 1994

750MG

N017129

001

65%

N017902

001

24%

N017903

001

10.3%

N009321

007

20%

N009321

001

N018289

001

N016666

001

N015419

002

N017313

001

N018077
N018076

001
001

1mCi/ML

N019432

001

Dec 24, 1987

45.3%

N018956

006

Jun 30, 1989

15.1%

N018956

007

Jun 01, 1994

IOCETAMIC ACID
TABLET; ORAL
CHOLEBRINE
MALLINCKRODT

IODAMIDE MEGLUMINE
INJECTABLE; INJECTION
RENOVUE-65
BRACCO
RENOVUE-DIP
BRACCO

IODIPAMIDE MEGLUMINE
INJECTABLE; INJECTION
CHOLOGRAFIN MEGLUMINE
BRACCO

IODIPAMIDE SODIUM
INJECTABLE; INJECTION
CHOLOGRAFIN SODIUM
BRACCO

IODOHIPPURATE SODIUM I-123

INJECTABLE; INJECTION
NEPHROFLOW
GE HEALTHCARE

1mCi/ML

Dec 28, 1984

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

IOHEXOL
INJECTABLE; INJECTION
OMNIPAQUE 210
GE HEALTHCARE
SOLUTION; URETHRAL
OMNIPAQUE 70
GE HEALTHCARE

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DISCONTINUED DRUG PRODUCT LIST

6 - 191 (of 346)

IOPAMIDOL
INJECTABLE; INJECTION
IOPAMIDOL
BAXTER HLTHCARE

HOSPIRA

41%
51%
61%
76%
61%
76%

A074629
A074629
A074629
A074629
A074734
A074734

001
004
002
003
001
002

Nov
Mar
Nov
Nov
Dec
Dec

A074881
A074898

001
001

Jul 28, 2000

Dec 30, 1997

A074636

001

Dec 30, 1997

A074881
A074898
A075005

002
002
001

Jul 28, 2000

Dec 30, 1997
Feb 24, 1998

A074636

002

Dec 30, 1997

A074638
A074881
A074898
A075005

001
003
003
002

Apr
Jul
Dec
Feb

A074636
A074637

003
001

Dec 30, 1997

Apr 03, 1997

A074881
A074898
A075005

004
004
003

Jul 28, 2000

Dec 30, 1997
Feb 24, 1998

A074636

004

Dec 30, 1997

N018735

005

Oct 21, 1986

N020327

001

Oct 12, 1994

500MG

N008032

001

100%

N005319

001

52%;26%

N016783

001

80%

N013319

001

54.3%

N017685

001

66.8%

N014295

001

IOPAMIDOL-200
COOK IMAGING
41%
HOSPIRA
41%
IOPAMIDOL-200 IN PLASTIC CONTAINER
HOSPIRA
41%
IOPAMIDOL-250
COOK IMAGING
51%
HOSPIRA
51%
51%
IOPAMIDOL-250 IN PLASTIC CONTAINER
HOSPIRA
51%
IOPAMIDOL-300
ABBOTT
61%
COOK IMAGING
61%
HOSPIRA
61%
61%
IOPAMIDOL-300 IN PLASTIC CONTAINER
HOSPIRA
61%
61%
IOPAMIDOL-370
COOK IMAGING
76%
HOSPIRA
76%
76%
IOPAMIDOL-370 IN PLASTIC CONTAINER
HOSPIRA
76%
ISOVUE-128
BRACCO
26%
ISOVUE-200
BRACCO
41%

IOPANOIC ACID
TABLET; ORAL
TELEPAQUE
GE HEALTHCARE

IOPHENDYLATE
INJECTABLE; INJECTION
PANTOPAQUE
ALCON

IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM

INJECTABLE; INJECTION
VASCORAY
MALLINCKRODT

IOTHALAMATE SODIUM
INJECTABLE; INJECTION
ANGIO-CONRAY
MALLINCKRODT
CONRAY 325
MALLINCKRODT
CONRAY 400
MALLINCKRODT

06,
31,
06,
06,
10,
10,

30,
28,
30,
24,

1996
1998
1996
1996
1996
1996

1997
2000
1997
1998

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6 - 192 (of 346)

IOTHALAMATE SODIUM I-125

INJECTABLE; INJECTION
GLOFIL-125
ISOTEX

250-300uCi/ML

N017279

001

40.6%

N019580

001

Dec 07, 1989

51.3%

N019580

002

Dec 07, 1989

34%

N019710

003

Dec 30, 1988

51%

N020923

001

May 28, 1998

68%

N020923

002

May 29, 1998

3GM/PACKET

N012968

001

500MG

A087768

001

500MG

N012967

001

N019085

001

Dec 29, 1986

N020228

001

Sep 29, 1993

A075111
A075507
A075867

001
001
001

Apr 22, 1999

Jan 19, 2001
Jul 22, 2002

A077994
A077994

001
002

Feb 27, 2008

Feb 27, 2008

EQ 50MG IRON/ML

N010787

002

EQ 75MG BASE/3.75ML (EQ 20MG BASE/ML)

N021135

003

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

Aug 11, 1982

IPRATROPIUM BROMIDE
AEROSOL, METERED; INHALATION
ATROVENT
BOEHRINGER INGELHEIM 0.018MG/INH
SOLUTION; INHALATION
ATROVENT
BOEHRINGER INGELHEIM 0.02%
IPRATROPIUM BROMIDE
ACTAVIS MID ATLANTIC 0.02%
PHARMASCIENCE INC
0.02%
ROXANE
0.02%

IRINOTECAN HYDROCHLORIDE
INJECTABLE; INJECTION
IRINOTECAN HYDROCHLORIDE
SANDOZ
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)

IRON DEXTRAN
INJECTABLE; INJECTION
IRON DEXTRAN
SANOFI AVENTIS US

IRON SUCROSE
INJECTABLE; INTRAVENOUS
VENOFER
LUITPOLD

Mar 29, 2005

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6 - 193 (of 346)

ISOETHARINE HYDROCHLORIDE
SOLUTION; INHALATION
BETA-2
NEPHRON
BRONKOSOL
SANOFI AVENTIS US

1%

0.25%
1%
ISOETHARINE HYDROCHLORIDE
ALPHARMA US PHARMS
1%
ASTRAZENECA
0.062%
0.062%
0.125%
0.125%
0.167%
0.167%
0.2%
0.2%
0.25%
0.25%
BAXTER HLTHCARE
0.08%
0.14%
0.25%
DEY
0.08%
0.1%
0.17%
0.25%
1%
INTL MEDICATION
0.077%
0.08%
0.1%
0.143%
0.167%
0.2%
0.25%
1%
PARKE DAVIS
0.5%
1%
ROXANE
0.1%
0.125%
0.167%
0.2%
0.25%
1%
ISOETHARINE HYDROCHLORIDE S/F
DEY
0.08%
0.1%
0.17%
0.25%
1%

A086711

001

N012339
N012339

009
008

A087101
A087937
A089614
A087938
A089615
A088470
A089616
A088471
A089617
A088472
A089618
A088144
A088145
A088146
A088187
A087389
A087390
A088188
A086763
A086651
A086651
A086651
A086651
A086651
A086651
A086651
A086651
A085997
A085889
A087396
A087025
A088226
A087324
A088275
A086899

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
003
004
005
006
007
008
001
001
001
001
001
001
001
001

A089817
A089818
A089819
A089820
A089252

001
001
001
001
001

N012339

007

A087858

001

Aug 21, 1984

A074393

001

May 12, 1995

Nov
Jun
Nov
Jun
Mar
Jun
Mar
Jun
Mar
Jun
Jul
Mar
Aug
Dec

15,
13,
15,
13,
14,
13,
14,
13,
14,
13,
29,
26,
01,
03,

1982
1991
1982
1991
1984
1991
1984
1991
1984
1991
1983
1984
1983
1982

Dec 03, 1982

Sep 16, 1983

Jun 03, 1983

Nov
Nov
Nov
Nov
Sep

22,
22,
22,
22,
15,

1988
1988
1988
1988
1986

ISOETHARINE MESYLATE
AEROSOL, METERED; INHALATION
BRONKOMETER
SANOFI AVENTIS US
0.34MG/INH
ISOETHARINE MESYLATE
ALPHARMA US PHARMS
0.34MG/INH

ISOFLURANE
LIQUID; INHALATION
ISOFLURANE
MARSAM PHARMS LLC

99.9%

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DISCONTINUED DRUG PRODUCT LIST

6 - 194 (of 346)

ISOFLUROPHATE
OINTMENT; OPHTHALMIC
FLOROPRYL
MERCK

0.025%

N010656

001

100MG/ML

N008662

001

25MG/ML
100MG/ML

N008420
N008420

002
003

50MG/5ML

A081118

001

Jul 21, 1997

50MG/5ML

A089243

001

Feb 03, 1986

50MG/5ML

N008420

001

300MG

A080330

002

100MG
300MG

A080134
A080134

003
004

300MG

A080935

001

100MG
300MG
50MG
100MG
100MG
300MG
100MG
300MG
100MG
100MG
300MG
100MG
50MG
100MG
300MG
100MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
100MG
100MG
300MG
300MG
100MG

A088231
A088119
A083632
A080153
A080270
A083610
N008499
N008499
A080941
A080136
A083633
A084050
N008428
N008428
N008428
A083060
A085091
A080368
A080368
A080132
A080132
A080522
A080401
A080523
A085790
A083178
A085784
A080120

001
001
001
001
001
001
002
003
001
001
001
001
001
002
003
001
001
001
002
003
004
001
001
001
001
001
001
002

50MG
100MG
300MG

A080140
A080140
A089776

001
002
001

100MG

N008392

003

ISONIAZID
INJECTABLE; INJECTION
NYDRAZID
SANDOZ
RIMIFON
ROCHE
SYRUP; ORAL
ISONIAZID
MIKART
LANIAZID
LANNETT
RIMIFON
ROCHE
TABLET; ORAL
DOW-ISONIAZID
DOW PHARM
HYZYD
MEDPOINTE PHARM HLC
INH
NOVARTIS
ISONIAZID
DURAMED PHARMS BARR
HALSEY
IMPAX LABS
IVAX SUB TEVA PHARMS
LILLY
MK LABS
MUTUAL PHARM
NEXGEN PHARMA INC
PANRAY

PERRIGO
PHARMAVITE
PHOENIX LABS NY
PUREPAC PHARM
WATSON LABS

WHITEWORTH TOWN PLSN

LANIAZID
LANNETT

NYDRAZID
BRISTOL MYERS SQUIBB

Mar 17, 1983

Mar 17, 1983

Jul 14, 1982

Jul 14, 1982

Jun 13, 1988

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DISCONTINUED DRUG PRODUCT LIST

6 - 195 (of 346)

ISONIAZID
TABLET; ORAL
STANOZIDE
EVERYLIFE

100MG
300MG

A080126
A080126

001
002

EQ 5MG BASE

N010744

001

N010375
A085904

004
001

N011178

001

N016814

001

A083431
A083486
A083283
A083346

001
001
001
001

N007245

001

A087935
A087936
A086764
A085994
A085540

001
001
001
001
001

N006327
N006327

002
003

N016813

001

N006328
N006328

001
002

N013296

001

N010375

003

N006905
N006905

003
002

N017063

001

ISOPROPAMIDE IODIDE
TABLET; ORAL
DARBID
GLAXOSMITHKLINE

ISOPROTERENOL HYDROCHLORIDE
AEROSOL, METERED; INHALATION
ISOPROTERENOL HYDROCHLORIDE
3M
0.12MG/INH
ALPHARMA US PHARMS
0.12MG/INH
ISUPREL
SANOFI AVENTIS US
0.103MG/INH
DISC; INHALATION
NORISODRINE AEROTROL
ABBOTT
0.25%
INJECTABLE; INJECTION
ISOPROTERENOL HYDROCHLORIDE
ABRAXIS PHARM
0.2MG/ML
BAXTER HLTHCARE
0.2MG/ML
HOSPIRA
0.02MG/ML
0.2MG/ML
SOLUTION; INHALATION
AEROLONE
LILLY
0.25%
ISOPROTERENOL HYDROCHLORIDE
ARMOUR PHARM
0.031%
0.062%
DEY
0.5%
PARKE DAVIS
0.25%
0.5%
ISUPREL
SANOFI AVENTIS US
0.5%
1%
VAPO-ISO
FISONS
0.5%
TABLET; RECTAL, SUBLINGUAL
ISUPREL
SANOFI AVENTIS US
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
0.08MG/INH
POWDER; INHALATION
NORISODRINE
ABBOTT
10%
25%

ISOSORBIDE
SOLUTION; ORAL
ISMOTIC
ALCON

100GM/220ML

Nov 18, 1982

Nov 18, 1982
Jan 04, 1982

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DISCONTINUED DRUG PRODUCT LIST

6 - 196 (of 346)

ISOSORBIDE DINITRATE
CAPSULE, EXTENDED RELEASE; ORAL
ISORDIL
WYETH AYERST
40MG
TABLET; ORAL
ISOSORBIDE DINITRATE
MUTUAL PHARM
5MG
10MG
20MG
30MG
SUPERPHARM
5MG
10MG
20MG
SORBITRATE
ASTRAZENECA
5MG
10MG
20MG
30MG
40MG
TABLET; SUBLINGUAL
ISORDIL
BIOVAIL
2.5MG
5MG
10MG
ISOSORBIDE DINITRATE
MUTUAL PHARM
2.5MG
5MG
10MG
SANDOZ
2.5MG
5MG
SORBITRATE
ASTRAZENECA
2.5MG
5MG
TABLET, CHEWABLE; ORAL
SORBITRATE
ASTRAZENECA
5MG
10MG
TABLET, EXTENDED RELEASE; ORAL
ISORDIL
WYETH AYERST
40MG

N012882

002

Jul 29, 1988

A086166
A086169
A086167
A087564
A089190
A089191
A089192

002
001
001
001
001
001
001

Sep
Sep
Sep
Sep
Feb
Feb
Feb

19,
19,
19,
18,
17,
17,
17,

1986
1986
1986
1986
1987
1987
1987

N016192
N016192
A086405
A088124
A088125

001
002
002
001
001

Apr
Apr
Aug
Aug
Aug

01,
01,
21,
21,
21,

1996
1996
1990
1990
1990

N012940
N012940
N012940

004
003
005

Jul 29, 1988

Jul 29, 1988
Jul 29, 1988

A084204
A086168
A087545
A086225
A086222

001
001
001
001
001

Sep
Sep
Sep
Feb
Feb

N016191
N016191

002
001

Apr 01, 1996

Apr 01, 1996

N016776
N016776

002
003

Apr 01, 1996

Apr 01, 1996

N012882

001

Jul 29, 1988

N019091

001

Dec 30, 1991

N020225
N020225
N020225

001
002
003

Aug 12, 1993

Aug 12, 1993
Mar 30, 1995

A075448
A075448
A075448

002
001
003

Aug 07, 2001

Jun 19, 2000
Aug 07, 2001

N018662
N018662
N018662

002
004
003

May 07, 1982

Mar 28, 1983
May 07, 1982

18,
18,
18,
19,
19,

1986
1986
1986
1988
1988

ISOSORBIDE MONONITRATE
TABLET; ORAL
ISMO
PROMIUS PHARMA
20MG
TABLET, EXTENDED RELEASE; ORAL
IMDUR
SCHERING PLOUGH
30MG
60MG
120MG
ISOSORBIDE MONONITRATE
IVAX SUB TEVA PHARMS 30MG
60MG
120MG

ISOTRETINOIN
CAPSULE; ORAL
ACCUTANE
HOFFMANN LA ROCHE

10MG
20MG
40MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 197 (of 346)

ISRADIPINE
CAPSULE; ORAL
DYNACIRC
SMITHKLINE BEECHAM

2.5MG
5MG

N019546
N019546

001
002

Dec 20, 1990

Dec 20, 1990

10MG/ML

N020966

001

Mar 30, 1999

6MG

N050742

001

Nov 22, 1996

EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE

A060516
A061911
A062726

001
001
001

Mar 06, 1987

EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
EQ 1GM BASE/3ML

A062324
A062324
A062324

001
002
003

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

75MG BASE/2ML
500MG BASE/2ML
1GM BASE/3ML
500MG BASE/2ML
1GM BASE/3ML
75MG BASE/2ML
500MG BASE/2ML
1GM BASE/3ML
75MG BASE/2ML
500MG BASE/2ML
1GM BASE/3ML
75MG BASE/2ML
500MG BASE/2ML
1GM BASE/3ML
1GM BASE/3ML
1GM BASE/3ML

A062504
A062504
A062504
A062466
A062466
A063021
A063022
A063025
A062668
A062672
A062669
A062605
A062605
A062605
A063092
A062520

001
002
003
001
002
001
001
001
001
001
001
003
001
002
001
003

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

75MG BASE/2ML
75MG BASE/2ML
75MG BASE/2ML
500MG BASE/2ML
500MG BASE/2ML
500MG BASE/2ML
1GM BASE/3ML
1GM BASE/3ML
1GM BASE/3ML

A061655
A061901
A062564
A061655
A061901
A062564
A061655
A061901
A062564

003
003
001
001
001
002
002
002
003

EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
EQ 1GM BASE/3ML

A062170
A062170
A062170

001
002
003

2%

N019084

001

ITRACONAZOLE
INJECTABLE; INJECTION
SPORANOX
JANSSEN PHARMS

IVERMECTIN
TABLET; ORAL
STROMECTOL
MERCK

KANAMYCIN SULFATE
CAPSULE; ORAL
KANTREX
APOTHECON

INJECTABLE; INJECTION
KANAMYCIN
BAXTER HLTHCARE

KANAMYCIN SULFATE
ABRAXIS PHARM

INTL MEDICATION
LOCH

PHARMAFAIR

SOLOPAK

WARNER CHILCOTT
WATSON LABS
KANTREX
APOTHECON

KLEBCIL
KING PHARMS

Apr
Apr
Apr
Sep
Sep
Jul
Jul
Jul
May
May
May
Feb
Feb
Feb
Oct
May

05,
05,
05,
30,
30,
31,
31,
31,
07,
07,
07,
26,
26,
26,
11,
09,

1984
1984
1984
1983
1983
1992
1992
1992
1987
1987
1987
1986
1986
1986
1989
1985

Sep 21, 1984

Sep 21, 1984

Sep 21, 1984

KETOCONAZOLE
CREAM; TOPICAL
NIZORAL
JANSSEN PHARMA

Dec 31, 1985

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DISCONTINUED DRUG PRODUCT LIST

6 - 198 (of 346)

KETOCONAZOLE
SUSPENSION; ORAL
NIZORAL
JANSSEN PHARMA
TABLET; ORAL
KETOCONAZOLE
AAIPHARMA LLC
TEVA

100MG/5ML

A070767

001

Nov 07, 1986

200MG
200MG

A075341
A074971

001
001

Jul 27, 1999

Jun 15, 1999

50MG
75MG
25MG

A074024
A074024
A073515

001
002
001

Dec 29, 1995

Dec 29, 1995
Dec 22, 1992

N018754
N018754
N018754

001
002
003

Jul 31, 1987

Jan 09, 1986
Jan 09, 1986

N019816
N019816
N019816

003
002
001

Feb 08, 1995

Feb 08, 1995
Sep 24, 1993

N020499

001

Oct 06, 1995

A075364

001

Feb 07, 2002

N020429

001

Oct 06, 1995

15MG/ML
30MG/ML
30MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML

A076209
A076209
A075626
A077201
A075348
A075348
A075230
A075230
A076722
A076722
A074801
A074801

001
002
001
001
001
002
002
001
001
002
001
002

Jul
Jul
Jul
Oct
Nov
Nov
Oct
Oct
Jul
Jul
Jun
Jun

15MG/ML
30MG/ML

N019698
N019698

001
002

Nov 30, 1989

Nov 30, 1989

10MG
10MG

A074790
A074955

001
001

Jun 26, 1997

Sep 19, 1997

10MG

N019645

001

Dec 20, 1991

N018088

001

KETOPROFEN
CAPSULE; ORAL
KETOPROFEN
SANDOZ
TEVA
ORUDIS
WYETH AYERST

25MG
50MG
75MG
CAPSULE, EXTENDED RELEASE; ORAL
ORUVAIL
WYETH PHARMS INC
100MG
150MG
200MG
TABLET; ORAL
ACTRON
BAYER
12.5MG
KETOPROFEN
PERRIGO
12.5MG
ORUDIS KT
WYETH CONS
12.5MG

KETOROLAC TROMETHAMINE
INJECTABLE; INJECTION
KETOROLAC TROMETHAMINE
AMPHASTAR PHARM
APOTEX INC
APOTHECON
BEDFORD
GLAND PHARMA LTD
HOSPIRA
TORADOL
ROCHE PALO
TABLET; ORAL
KETOROLAC TROMETHAMINE
ROXANE
WATSON LABS
TORADOL
ROCHE PALO

KRYPTON, KR-81M
GAS; INHALATION
MPI KRYPTON 81M GENERATOR
GE HEALTHCARE
N/A

21,
21,
24,
14,
28,
28,
25,
25,
27,
27,
05,
05,

2004
2004
2001
2005
2000
2000
1999
1999
2004
2004
1997
1997

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DISCONTINUED DRUG PRODUCT LIST

6 - 199 (of 346)

LABETALOL HYDROCHLORIDE
INJECTABLE; INJECTION
LABETALOL HYDROCHLORIDE
APOTHECON
HOSPIRA
NORMODYNE
SCHERING
TRANDATE
PROMETHEUS LABS
TABLET; ORAL
LABETALOL HYDROCHLORIDE
APOTHECON

MUTUAL PHARM

TEVA

NORMODYNE
SCHERING

TRANDATE
PROMETHEUS LABS

5MG/ML
5MG/ML

A075355
A075242

001
001

Nov 29, 1999

Sep 30, 1999

5MG/ML

N018686

001

Aug 01, 1984

5MG/ML

N019425

001

Dec 31, 1985

100MG
200MG
300MG
100MG
200MG
300MG
100MG
200MG
300MG

A075223
A075223
A075223
A075215
A075215
A075215
A074989
A074989
A074989

001
002
003
001
002
003
001
002
003

Nov
Nov
Nov
Jul
Jul
Jul
Sep
Sep
Sep

20,
20,
20,
29,
29,
29,
30,
30,
30,

1998
1998
1998
1999
1999
1999
1998
1998
1998

100MG
200MG
300MG
400MG

N018687
N018687
N018687
N018687

001
002
003
004

Aug
Aug
Aug
Aug

31,
01,
01,
01,

1987
1984
1984
1984

300MG
400MG

N018716
N018716

003
004

Aug 01, 1984

Aug 01, 1984

10GM/15ML

N017884

001

10GM/15ML

A072372

001

Mar 22, 1989

10GM/15ML

A073497

001

May 28, 1993

10GM/15ML
10GM/15ML

A071841
A073160

001
001

Sep 22, 1988

Aug 25, 1992

10GM/15ML

A073686

001

May 28, 1993

10GM/15ML

A073685

001

May 28, 1993

10GM/15ML

N017657

001

10GM/15ML

A071842

001

Sep 27, 1988

10GM/15ML

A073504

001

May 28, 1993

10GM/15ML
10GM/15ML
10GM/15ML

A072029
A073590
N017906

001
001
001

Aug 25, 1992

May 29, 1992

10GM/15ML

A072374

001

Mar 22, 1989

50MG
250MG

N020241
N020241

006
004

Dec 27, 1994

Dec 27, 1994

LACTULOSE
SOLUTION; ORAL
CHRONULAC
SANOFI AVENTIS US
DUPHALAC
SOLVAY
EVALOSE
TEVA PHARMS
LACTULOSE
MORTON GROVE
PACO
LAXILOSE
NOSTRUM LABS
SOLUTION; ORAL, RECTAL
ACILAC
NOSTRUM LABS
CEPHULAC
SANOFI AVENTIS US
GENERLAC
MORTON GROVE
HEPTALAC
TEVA PHARMS
LACTULOSE
PACO
ROXANE
SOLVAY
PORTALAC
SOLVAY

LAMOTRIGINE
TABLET; ORAL
LAMICTAL
GLAXOSMITHKLINE

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6 - 200 (of 346)

LAMOTRIGINE
TABLET; ORAL
LAMOTRIGINE
MATRIX LABS LTD

MYLAN

ROXANE

WOCKHARDT

TABLET, CHEWABLE; ORAL

LAMICTAL CD
GLAXOSMITHKLINE
LAMOTRIGINE
SANDOZ

25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG
25MG
100MG
150MG
200MG

A078443
A078443
A078443
A078443
A077428
A077428
A077428
A077428
A077392
A077392
A077392
A077392
A078982
A078982
A078982
A078982

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Feb
Feb
Feb
Feb
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan
Jan

11,
11,
11,
11,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,

2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009

100MG

N020764

003

Aug 24, 1998

5MG
25MG

A078409
A078409

002
003

Jan 22, 2009

Jan 22, 2009

N021281
N021281

001
002

May 03, 2001

May 03, 2001

N021566

001

May 27, 2004

N021507

002

Nov 14, 2003

N021507

003

Nov 14, 2003

N021507

004

Nov 14, 2003

N021468

001

Oct 26, 2004

0.5%;1.8%

N011914

001

10MG
20MG

A077085
A077085

001
002

LANSOPRAZOLE
FOR SUSPENSION, DELAYED RELEASE; ORAL
PREVACID
TAKEDA PHARMS NA
15MG/PACKET
30MG/PACKET
INJECTABLE; INTRAVENOUS
PREVACID IV
TAKEDA PHARMS NA
30MG/VIAL

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

EQ 250MG BASE

LAPYRIUM CHLORIDE; UNDECOYLIUM CHLORIDE IODINE COMPLEX

SOLUTION; TOPICAL
VIRAC REX
CHESEBROUGH PONDS

LEFLUNOMIDE
TABLET; ORAL
LEFLUNOMIDE
SANDOZ

Sep 13, 2005

Sep 13, 2005

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DISCONTINUED DRUG PRODUCT LIST

6 - 201 (of 346)

LETROZOLE
TABLET; ORAL
LETROZOLE
SYNTHON PHARMS

2.5MG

A090196

001

Jun 03, 2011

EQ 60MG BASE/VIAL

N008107

003

Jan 30, 1987

A089352
A089353
A088939
A070480
A081224
N008107
N008107
N008107
N008107
A040262
A089628
A089915

001
001
001
001
001
001
002
004
005
001
001
001

Jun
Jun
Dec
Jan
Jun

01,
01,
01,
02,
03,

1988
1988
1986
1987
1994

May
Apr
Dec
Apr
Apr

23,
05,
15,
17,
17,

1988
1989
1999
1997
1997

A040147
A040332

001
001

Jun 25, 1997

Jun 28, 1999

A087439
A089833
A089465
A089834

001
001
001
001

Oct
Jan
Jan
Jan

19,
23,
23,
23,

1982
1989
1989
1989

A074544
A074544
A071600
A071598
A073099
A073101
A075327
N018459
A071962
A071104

001
002
001
001
001
001
001
001
001
001

Aug
Aug
Oct
Oct
Mar
Mar
Mar
Jan
Nov
Mar

28,
28,
14,
14,
28,
28,
24,
30,
19,
04,

1997
1997
1987
1987
1997
1997
1999
1986
1987
1987

N018342
N018342

001
002

Jul 08, 1983

Jul 08, 1983

EQ 65MG BASE

N021088

001

Mar 03, 2000

1MG/0.2ML

A075721

001

Nov 29, 2001

1MG/0.2ML

N019010

001

Apr 09, 1985

3.75MG/VIAL,7.5MG/VIAL
7.5MG/VIAL,7.5MG/VIAL

N020263
N020263

003
004

Apr 16, 1993

Apr 16, 1993

LEUCOVORIN CALCIUM
FOR SOLUTION; ORAL
LEUCOVORIN CALCIUM
HOSPIRA
INJECTABLE; INJECTION
LEUCOVORIN CALCIUM
ABIC

EQ 3MG BASE/ML
EQ 50MG BASE/VIAL
EQ 50MG BASE/VIAL
ABRAXIS PHARM
ELKINS SINN
EQ 50MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 3MG BASE/ML
HOSPIRA
EQ 50MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 350MG BASE/VIAL
PHARMACHEMIE
EQ 350MG BASE/VIAL
PHARMACHEMIE USA
EQ 50MG BASE/VIAL
EQ 100MG BASE/VIAL
LEUCOVORIN CALCIUM PRESERVATIVE FREE
EQ 10MG BASE/ML
HOSPIRA
EQ 10MG BASE/ML
TEVA PARENTERAL
WELLCOVORIN
EQ 5MG BASE/ML
GLAXOSMITHKLINE
EQ 25MG BASE/VIAL
EQ 50MG BASE/VIAL
EQ 100MG BASE/VIAL
TABLET; ORAL
LEUCOVORIN CALCIUM
EQ 5MG BASE
COREPHARMA
EQ 25MG BASE
EQ 5MG BASE
PAR PHARM
EQ 25MG BASE
EQ 5MG BASE
PHARMACHEMIE
EQ 25MG BASE
EQ 15MG BASE
SANDOZ
EQ 5MG BASE
XANODYNE PHARM
EQ 10MG BASE
EQ 15MG BASE
WELLCOVORIN
EQ 5MG BASE
GLAXOSMITHKLINE
EQ 25MG BASE

LEUPROLIDE ACETATE
IMPLANT; IMPLANTATION
VIADUR
ORTHO MCNEIL JANSSEN
INJECTABLE; INJECTION
LEUPROLIDE ACETATE
GENZYME
LUPRON
ABBOTT LABS
LUPRON DEPOT-PED
ABBOTT ENDOCRINE

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DISCONTINUED DRUG PRODUCT LIST

6 - 202 (of 346)

LEVALLORPHAN TARTRATE
INJECTABLE; INJECTION
LORFAN
ROCHE

1MG/ML

N010423

001

EQ 50MG BASE

N020035

001

Jun 18, 1990

250MG
500MG
750MG
1GM
250MG
500MG
750MG

A078731
A078731
A078731
A078731
A077408
A077408
A077408

001
002
003
004
001
002
003

Feb
Feb
Feb
Feb
Mar
Mar
Mar

N021114

001

Feb 23, 2000

N020997
N020997
N020997

001
002
003

Aug 05, 1999

Aug 05, 1999
Aug 05, 1999

N020219

001

Nov 10, 1993

1GM/10ML

N018948

002

Apr 27, 1988

100MG
250MG
500MG

N016948
N016948
N016948

003
001
002

100MG
250MG
500MG

N016913
N016913
N016913

003
001
002

100MG
250MG
500MG

N016912
N016912
N016912

002
001
006

250MG
500MG

N016913
N016913

004
005

100MG

N016912

005

LEVAMISOLE HYDROCHLORIDE
TABLET; ORAL
ERGAMISOL
JANSSEN PHARMA

LEVETIRACETAM
TABLET; ORAL
LEVETIRACETAM
MYLAN

WATSON LABS FLORIDA

10,
10,
10,
10,
02,
02,
02,

2009
2009
2009
2009
2009
2009
2009

LEVOBETAXOLOL HYDROCHLORIDE
SUSPENSION/DROPS; OPHTHALMIC
BETAXON
ALCON PHARMS LTD
EQ 0.5% BASE

LEVOBUPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION
CHIROCAINE
PURDUE PHARMA LP

EQ 2.5MG BASE/ML
EQ 5MG BASE/ML
EQ 7.5MG BASE/ML

LEVOCABASTINE HYDROCHLORIDE
SUSPENSION/DROPS; OPHTHALMIC
LIVOSTIN
NOVARTIS
EQ 0.05% BASE

LEVOCARNITINE
SOLUTION; ORAL
CARNITOR
SIGMA TAU

LEVODOPA
CAPSULE; ORAL
BENDOPA
VALEANT PHARM INTL

DOPAR
SHIRE

LARODOPA
ROCHE

TABLET; ORAL
DOPAR
SHIRE
LARODOPA
ROCHE

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DISCONTINUED DRUG PRODUCT LIST

6 - 203 (of 346)

LEVODOPA
TABLET; ORAL
LARODOPA
ROCHE

250MG
500MG

N016912
N016912

003
004

20MG/ML

N015865

001

N020315

001

A085010

001

N012125

002

A084850

002

Oct 21, 1983

A089517

001

Apr 14, 1988

LEVOMEPROMAZINE
INJECTABLE; INJECTION
LEVOPROME
IMMUNEX

LEVOMETHADYL ACETATE HYDROCHLORIDE

CONCENTRATE; ORAL
ORLAAM
ROXANE

10MG/ML

Jul 09, 1993

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

INJECTABLE; INJECTION
ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
SOLVAY
0.05MG/ML;2%
CARBOCAINE W/ NEO-COBEFRIN
EASTMAN KODAK
0.05MG/ML;2%
MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN
GRAHAM CHEM
0.05MG/ML;2%
POLOCAINE W/ LEVONORDEFRIN
DENTSPLY PHARM
0.05MG/ML;2%

LEVONORDEFRIN; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE

INJECTABLE; INJECTION
RAVOCAINE AND NOVOCAIN W/ NEO-COBEFRIN
EASTMAN KODAK
0.05MG/ML;2%;0.4%

N008592

007

N020627

001

Aug 15, 1996

N019897

001

Dec 10, 1990

N020544

001

Nov 01, 1996

N020088

001

Dec 10, 1990

N021045

001

Jul 28, 1999

EQ 50MG BASE
EQ 100MG BASE

N012928
N012928

006
004

EQ 50MG BASE/5ML

N012928

002

2MG/ML

N008719

001

Dec 19, 1991

2MG

N008720

001

Dec 19, 1991

LEVONORGESTREL
IMPLANT; IMPLANTATION
LEVONORGESTREL
WYETH PHARMS INC
75MG/IMPLANT
NORPLANT
POPULATION COUNCIL
36MG/IMPLANT
NORPLANT II
POPULATION COUNCIL
75MG/IMPLANT
NORPLANT SYSTEM IN PLASTIC CONTAINER
WYETH PHARMS INC
36MG/IMPLANT
TABLET; ORAL
PLAN B
TEVA WOMENS
0.75MG

LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS

CAPSULE; ORAL
NOVRAD
LILLY
SUSPENSION; ORAL
NOVRAD
LILLY

LEVORPHANOL TARTRATE
INJECTABLE; INJECTION
LEVO-DROMORAN
VALEANT PHARM INTL
TABLET; ORAL
LEVO-DROMORAN
VALEANT PHARM INTL

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DISCONTINUED DRUG PRODUCT LIST

6 - 204 (of 346)

LEVOTHYROXINE SODIUM**
TABLET; ORAL
LEVOLET
VINTAGE

-->

LEVOXYL
KING PHARMS
NOVOTHYROX
MERCK KGAA

0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG
0.3MG

N021137
N021137
N021137
N021137
N021137
N021137
N021137
N021137
N021137
N021137
N021137
N021137

001
002
003
004
005
006
007
008
009
010
011
012

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

-->

N021301

012

May 25, 2001

N021292
N021292
N021292
N021292
N021292
N021292
N021292
N021292
N021292
N021292
N021292
N021292

001
002
003
004
005
006
007
008
009
010
011
012

May
May
May
May
May
May
May
May
May
May
May
May

N014394

001

N020575

001

A084944
A084946
A084947

001
001
001

A080210

001

N008048

001

N020575

002

N014127

001

N013077

001

A084721

001

A087980
A089362

001
001

0.3MG

0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
0.175MG
0.2MG
0.3MG

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

31,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,
31,

2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003

2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002
2002

LIDOCAINE
AEROSOL; ORAL
XYLOCAINE
ASTRAZENECA
10%
FILM, EXTENDED RELEASE; BUCCAL
DENTIPATCH
NOVEN
23MG/PATCH
OINTMENT; TOPICAL
ALPHACAINE
CARLISLE
5%
5%
5%
LIDOCAINE
GRAHAM CHEM
5%
XYLOCAINE
ASTRAZENECA
5%
PATCH; TOPICAL
DENTIPATCH
NOVEN
46.1MG/PATCH
SOLUTION; TOPICAL
XYLOCAINE
ASTRAZENECA
5%
SUPPOSITORY; RECTAL
XYLOCAINE
ASTRAZENECA
100MG

May 21, 1996

May 21, 1996

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
ALPHACAINE HYDROCHLORIDE
CARLISLE
2%
LIDOCAINE HYDROCHLORIDE
ABBOTT
10%
20%

Feb 02, 1983

May 25, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 205 (of 346)

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
LIDOCAINE HYDROCHLORIDE
ABRAXIS PHARM
1%
A080420
1%
A086761
1.5%
A080420
2%
A080420
2%
A080420
2%
A086761
2%
N017508
4%
N017508
20%
N017508
AKORN
1%
A085037
2%
A085037
BAXTER HLTHCARE
1%
A080407
2%
A080407
BEL MAR
1%
A080710
2%
A080760
DELL LABS
1%
A083387
2%
A083388
ELKINS SINN
0.5%
A085131
4%
A084626
GD SEARLE LLC
1%
A083135
2%
A083135
GRAHAM CHEM
2%
A080504
HOSPIRA
1%
A040013
1.5%
A088330
2%
A088331
INTL MEDICATION
1%
A083173
1%
N017701
2%
A083173
2%
N017701
1GM/VIAL
N018543
2GM/VIAL
N018543
LYPHOMED
1%
A080390
2%
A080390
MILES
1%
A080414
2%
A080414
WATSON LABS
1%
A080377
1%
A083627
2%
A080377
2%
A083627
WYETH AYERST
1%
A083083
2%
A083083
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
100MG/100ML
N018461
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
200MG/100ML
N018967
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%
HOSPIRA
200MG/100ML
A083158
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT
200MG/100ML
N018954
HOSPIRA
200MG/100ML
N018388
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
400MG/100ML
N018967
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%
HOSPIRA
400MG/100ML
A083158
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
800MG/100ML
N018967
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRA
1.5%
A088326
10%
A088367
20%
A088368

001
001
005
002
004
002
001
002
004
001
002
001
002
001
001
001
001
001
001
001
002
001
001
001
001
001
002
002
001
001
002
001
002
001
002
001
001
002
002
001
002

Jun 23, 1995

May 17, 1984
May 17, 1984

001
001

Mar 30, 1984

005
001
001

Jul 09, 1985

002

Mar 30, 1984

006
003

Mar 30, 1984

001
001
001

Jul 31, 1984

Jul 31, 1984
Jul 31, 1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 206 (of 346)

LIDOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
BAXTER HLTHCARE
1%
2%
INTL MEDICATION
4%
LIDOCATON
PHARMATON
2%
XYLOCAINE
ASTRAZENECA
1%
1.5%
2%
INJECTABLE; SPINAL
XYLOCAINE 1.5% W/ DEXTROSE 7.5%
APP PHARMS
1.5%
XYLOCAINE 5% W/ GLUCOSE 7.5%
ASTRAZENECA
5%
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

A084625
A084625
N017702

001
002
002

A084727

001

N010418
N010418
N010418

005
009
007

N016297

001

N010496

002

Jul 07, 1982

A086578
A086389

001
001

Feb 02, 1982

A087931

001

Jun 10, 1983

A089688

001

Jun 30, 1989

A088542

001

Jul 31, 1984

A088572
A085995

001
001

Jul 31, 1984

N022114

001

Aug 16, 2007

2%;50MG/ML
2%;125MG/ML

A060567
A060567

001
002

2.5%;2.5%

N020962

001

EQ 250MG BASE
EQ 500MG BASE

N050316
N050316

001
002

A063180

001

1%
1%

A084218
N006309

001
001

1%

A084989

001

Aug 17, 1983

LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE

INJECTABLE; INJECTION
TERRAMYCIN
PFIZER

LIDOCAINE; PRILOCAINE
DISC; TOPICAL
EMLA
ASTRAZENECA

Feb 04, 1998

LINCOMYCIN HYDROCHLORIDE
CAPSULE; ORAL
LINCOCIN
PHARMACIA AND UPJOHN

INJECTABLE; INJECTION
LINCOMYCIN HYDROCHLORIDE
WATSON LABS
EQ 300MG BASE/ML

LINDANE
CREAM; TOPICAL
KWELL
REED AND CARNRICK
LOTION; TOPICAL
GAMENE
SOLA BARNES HIND

Apr 16, 1991

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6 - 207 (of 346)

LINDANE
LOTION; TOPICAL
KWELL
REED AND CARNRICK
SCABENE
STIEFEL
SHAMPOO; TOPICAL
GAMENE
SOLA BARNES HIND
KWELL
REED AND CARNRICK
SCABENE
STIEFEL

1%
1%

A084218
N006309

002
003

1%

A086769

001

1%

A084988

001

1%
1%

A084219
N010718

001
001

1%

A087940

001

Apr 08, 1983

400MG

N021130

001

Apr 18, 2000

EQ 0.025MG BASE
EQ 0.05MG BASE

A085755
A085753

001
001

Jan 25, 1982

Feb 03, 1982

0.03MG;0.0075MG

N016680

001

0.06MG;0.015MG

N016680

002

0.12MG;0.03MG

N016680

003

0.18MG;0.045MG

N016680

004

0.25MG;0.0625MG

N016807

006

2.5MG
5MG
10MG
20MG
30MG
40MG

A075783
A075783
A075783
A075783
A075783
A075783

001
002
003
004
005
006

Jul
Jul
Jul
Jul
Jul
Jul

2.5MG

N019558

006

Jan 28, 1994

300MG

N016860

001

150MG
300MG
300MG
600MG
300MG
300MG

A076823
A076121
A076823
A076823
A072542
A070407

001
001
002
003
001
001

LINEZOLID
TABLET; ORAL
ZYVOX
PHARMACIA AND UPJOHN

LIOTHYRONINE SODIUM
TABLET; ORAL
LIOTHYRONINE SODIUM
WATSON LABS

LIOTRIX (T4;T3)
TABLET; ORAL
EUTHROID-0.5
PARKE DAVIS
EUTHROID-1
PARKE DAVIS
EUTHROID-2
PARKE DAVIS
EUTHROID-3
PARKE DAVIS
THYROLAR-5
FOREST LABS

LISINOPRIL
TABLET; ORAL
LISINOPRIL
TEVA

PRINIVIL
MERCK

01,
01,
01,
01,
01,
01,

2002
2002
2002
2002
2002
2002

LITHIUM CARBONATE
CAPSULE; ORAL
ESKALITH
NOVEN THERAP
LITHIUM CARBONATE
ABLE

USL PHARMA
WATSON LABS

Jun
Sep
Jun
Jun
Feb
Mar

29,
27,
29,
29,
01,
19,

2004
2001
2004
2004
1989
1987

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6 - 208 (of 346)

LITHIUM CARBONATE
CAPSULE; ORAL
LITHONATE
SOLVAY
TABLET; ORAL
ESKALITH
JDS PHARMS
LITHANE
BAYER PHARMS
LITHIUM CARBONATE
PFIZER
LITHOTABS
SOLVAY
TABLET, EXTENDED RELEASE;
ESKALITH CR
JDS PHARMS
LITHIUM CARBONATE
ABLE
BARR

300MG

N016782

001

300MG

N017971

001

300MG

N018833

001

300MG

N016834

001

300MG
ORAL

N016980

001

450MG

N018152

001

Mar 29, 1982

300MG
300MG
450MG

A076382
A076170
A076366

001
001
001

Apr 21, 2003

Jun 10, 2002
Aug 21, 2003

EQ 300MG CARBONATE/5ML

N017672

001

N020013

001

N017690

001

A073080
A072993
A073122

001
001
001

Nov 27, 1991

Aug 28, 1992
Aug 30, 1991

N019037

001

Jul 31, 1984

A073187
A074991
A073478
A073062

001
001
001
001

Sep
Dec
Jun
May

A073528
A074194

001
001

Nov 30, 1993

Oct 30, 1992

200MG
400MG

N050668
N050668

001
002

Dec 31, 1991

Apr 05, 1996

100MG/5ML
200MG/5ML

N050667
N050667

001
002

Dec 31, 1991

Dec 31, 1991

Jul 18, 1985

LITHIUM CITRATE
SYRUP; ORAL
LITHONATE
SOLVAY

LOMEFLOXACIN HYDROCHLORIDE
TABLET; ORAL
MAXAQUIN
PHARMACIA

EQ 400MG BASE

Feb 21, 1992

LOPERAMIDE HYDROCHLORIDE
CAPSULE; ORAL
IMODIUM
MCNEIL PED
2MG
LOPERAMIDE HYDROCHLORIDE
ROXANE
2MG
SANDOZ
2MG
TEVA
2MG
SOLUTION; ORAL
IMODIUM
JANSSEN PHARMA
1MG/5ML
LOPERAMIDE HYDROCHLORIDE
ALPHARMA US PHARMS
1MG/5ML
DURAMED PHARMS BARR
1MG/5ML
TEVA
1MG/5ML
WATSON LABS
1MG/5ML
TABLET; ORAL
LOPERAMIDE HYDROCHLORIDE
ABLE
2MG
PERRIGO
2MG

15,
29,
23,
28,

1992
1997
1995
1993

LORACARBEF
CAPSULE; ORAL
LORABID
KING PHARMS
FOR SUSPENSION; ORAL
LORABID
KING PHARMS

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 209 (of 346)

LORATADINE
SYRUP; ORAL
CLARITIN HIVES RELIEF
SCHERING PLOUGH
TABLET; ORAL
LORATADINE
PERRIGO

1MG/ML

N020641

003

Nov 19, 2003

10MG

N021512

001

Jun 24, 2004

2MG/ML
2MG/ML
4MG/ML
2MG/ML
4MG/ML
2MG/ML
4MG/ML
4MG/ML
1MG/0.5ML
2MG/ML
2MG/ML
4MG/ML
4MG/ML

A074974
A074496
A074496
A074793
A074793
A074280
A074280
A074300
A074551
A074535
A074551
A074535
A074551

001
001
002
001
002
001
002
003
003
001
001
002
002

Jul
Sep
Sep
Mar
Mar
May
May
Mar
Sep
Sep
Sep
Sep
Sep

0.5MG/5ML

A074648

001

Mar 18, 1997

0.5MG
1MG
2MG

A070200
A070201
A070202

001
001
001

Aug 09, 1985

Aug 09, 1985
Aug 09, 1985

0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
0.5MG
1MG
1MG
2MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG
1MG
2MG
1MG
2MG
0.5MG
0.5MG
1MG
2MG
2MG

A070727
A070728
A070729
A071434
A071435
A071436
A070472
A072553
A070473
A072554
A070474
A072555
A070675
A070676
A070677
A071245
A071246
A071247
A070539
A070540
A071038
A071039
A071086
A071117
A071087
A071088
A071110

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Mar
Mar
Mar
Sep
Sep
Sep
Dec
Mar
Dec
Mar
Dec
Mar
Dec
Dec
Dec
Feb
Feb
Feb
Dec
Dec
Jan
Jan
Mar
Jul
Mar
Mar
Jul

LORAZEPAM
INJECTABLE; INJECTION
LORAZEPAM
AKORN
BAXTER HLTHCARE
DAVA PHARMS INC
HOSPIRA

MARSAM PHARMS LLC

SOLUTION; ORAL
LORAZEPAM
ROXANE
TABLET; ORAL
LORAZ
QUANTUM PHARMICS

LORAZEPAM
AM THERAP

HALSEY

MUTUAL PHARM

PAR PHARM

SUPERPHARM

USL PHARMA
WARNER CHILCOTT
WATSON LABS

23,
28,
28,
16,
16,
27,
27,
19,
12,
12,
12,
12,
12,

07,
07,
07,
01,
01,
01,
10,
29,
10,
29,
10,
29,
01,
01,
01,
09,
09,
09,
22,
22,
12,
12,
23,
24,
23,
23,
24,

1998
1998
1998
2000
2000
1994
1994
1997
1996
1996
1996
1996
1996

1986
1986
1986
1987
1987
1987
1985
1991
1985
1991
1985
1991
1986
1986
1986
1987
1987
1987
1986
1986
1988
1988
1987
1986
1987
1987
1986

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DISCONTINUED DRUG PRODUCT LIST

6 - 210 (of 346)

LOTEPREDNOL ETABONATE
SUSPENSION/DROPS; OPHTHALMIC
LOTEMAX
PHARMOS
0.5%

N020841

001

Mar 09, 1998

N019643

002

Mar 28, 1991

N021316

001

Jun 26, 2002

EQ 25MG BASE/ML

N017658

001

EQ 50MG BASE/ML

N018039

001

EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
25MG BASE
50MG BASE

A076868
A076868
A076868
A076868

001
002
003
004

EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
25MG BASE
50MG BASE

N017525
N017525
N017525
N017525

001

002

003

004

EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE

N017525
N017525
N017525

006

007

008

0.185MG/ML

N016755

001

LOVASTATIN
TABLET; ORAL
MEVACOR
MERCK
10MG
TABLET, EXTENDED RELEASE; ORAL
ALTOPREV
ANDRX LABS LLC
10MG

LOXAPINE HYDROCHLORIDE
CONCENTRATE; ORAL

LOXITANE C

WATSON LABS
INJECTABLE; INJECTION

LOXITANE IM

WATSON LABS

LOXAPINE SUCCINATE
CAPSULE; ORAL

LOXAPINE SUCCINATE

ACTAVIS TOTOWA

LOXITANE
WATSON LABS

TABLET; ORAL

LOXITANE

WATSON LABS

Aug
Aug
Aug
Aug

04,
04,
04,
04,

2005
2005
2005
2005

LYPRESSIN
SOLUTION; NASAL

DIAPID

NOVARTIS

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
G/100ML;530MG/100ML;500MG/100ML;12MG/10
0ML

001

Apr 04, 1984

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 N018252
/100ML;500MG/100ML
SOLUTION; IRRIGATION
PHYSIOSOL IN PLASTIC CONTAINER
HOSPIRA INC
14MG/100ML;37MG/100ML;222MG/100ML;526MG N018406
/100ML;502MG/100ML
PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER
HOSPIRA INC
30MG/100ML;37MG/100ML;222MG/100ML;526MG N018406
/100ML;502MG/100ML

001

001

002

Jul 08, 1982

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DISCONTINUED DRUG PRODUCT LIST

6 - 211 (of 346)

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM

GLUCONATE
SOLUTION; IRRIGATION
SYNOVALYTE IN PLASTIC CONTAINER
BAXTER HLTHCARE
30MG/100ML;37MG/100ML;368MG/100ML;526MG N019326
/100ML;502MG/100ML

001

Jan 25, 1985

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

TABLET, CHEWABLE; ORAL
ZEGERID
SANTARUS

700MG;20MG;600MG
700MG;40MG;600MG

N021850
N021850

001
002

Mar 24, 2006

Mar 24, 2006

37.9MG/ML

N020652

001

Nov 26, 1997

3.49MG/GM

N020686

001

Dec 19, 1997

EQ 0.1MG MANGANESE/ML

N019228

001

May 05, 1987

10GM/100ML
10GM/100ML

N016269
N016472

002
002

15GM/100ML
15GM/100ML

N016269
N016472

003
005

20GM/100ML
20GM/100ML

N016269
N016472

004
004

12.5GM/50ML
12.5GM/50ML
12.5GM/50ML
12.5GM/50ML
12.5GM/50ML
12.5GM/50ML

A086754
A089239
A089240
N016269
N005620
A087460

001
001
001
005
001
001

5GM/100ML

N016269

001

5GM/100ML

N016704

002

A080224

001

N017636

001

N017543

001

MANGAFODIPIR TRISODIUM
INJECTABLE; INJECTION
TESLASCAN
GE HEALTHCARE

MANGANESE CHLORIDE TETRAHYDRATE

FOR SOLUTION; ORAL
LUMENHANCE
BRACCO

MANGANESE SULFATE
INJECTABLE; INJECTION
MANGANESE SULFATE
ABRAXIS PHARM

MANNITOL
INJECTABLE; INJECTION
MANNITOL 10%
HOSPIRA
MILES
MANNITOL 15%
HOSPIRA
MILES
MANNITOL 20%
HOSPIRA
MILES
MANNITOL 25%
ABRAXIS PHARM
ASTRAZENECA
HOSPIRA
MERCK
WATSON LABS
MANNITOL 5%
HOSPIRA
SOLUTION; IRRIGATION
RESECTISOL
B BRAUN

MANNITOL; SORBITOL
SOLUTION; IRRIGATION

SORBITOL-MANNITOL

HOSPIRA
540MG/100ML;2.7GM/100ML
SORBITOL-MANNITOL IN PLASTIC CONTAINER

HOSPIRA
540MG/100ML;2.7GM/100ML

MAPROTILINE HYDROCHLORIDE
TABLET; ORAL

LUDIOMIL

NOVARTIS

25MG

May 06, 1987

May 06, 1987

Jun 27, 1983

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6 - 212 (of 346)

MAPROTILINE HYDROCHLORIDE
TABLET; ORAL
LUDIOMIL
NOVARTIS

50MG
75MG
MAPROTILINE HYDROCHLORIDE
AM THERAP
25MG
50MG
75MG
WATSON LABS
25MG
25MG
50MG
50MG
75MG
75MG

N017543
N017543

002
003

Sep 30, 1982

A072129
A072130
A072131
A071943
A072162
A071944
A072163
A071945
A072164

001
001
001
001
001
001
001
001
001

Jan
Jan
Jan
Dec
Jun
Dec
Jun
Dec
Jun

10%

N019940

001

Sep 04, 1992

1MG
2MG

N017980
N017980

002
001

1MG
2MG

N017247
N017247

001
002

100MG

N017481

001

600MG

N017374

001

N010251

001

N021884

001

A085253
A085252
A085891
A084382
A084872
A083784
A084975
A084657
A085524
A085523

001
001
001
001
001
001
001
001
001
001

14,
14,
14,
30,
01,
30,
01,
30,
01,

1988
1988
1988
1987
1988
1987
1988
1987
1988

MASOPROCOL
CREAM; TOPICAL
ACTINEX
UNIV AZ CANCER CTR

MAZINDOL
TABLET; ORAL
MAZANOR
WYETH AYERST
SANOREX
NOVARTIS

MEBENDAZOLE
TABLET, CHEWABLE; ORAL
VERMOX
JANSSEN PHARMS

MEBUTAMATE
TABLET; ORAL
DORMATE
MEDPOINTE PHARM HLC

MECAMYLAMINE HYDROCHLORIDE
TABLET; ORAL
INVERSINE
TARGACEPT

2.5MG

MECASERMIN RINFABATE RECOMBINANT

INJECTABLE; SUBCUTANEOUS
IPLEX
INSMED

36MG/0.6ML

MECLIZINE HYDROCHLORIDE
TABLET; ORAL
MECLIZINE HYDROCHLORIDE
ABC HOLDING
12.5MG
25MG
ANABOLIC
25MG
BUNDY
12.5MG
25MG
IVAX SUB TEVA PHARMS 12.5MG
12.5MG
25MG
KV PHARM
12.5MG
25MG

Dec 12, 2005

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6 - 213 (of 346)

MECLIZINE HYDROCHLORIDE
TABLET; ORAL
MECLIZINE HYDROCHLORIDE
PLIVA
12.5MG
25MG
SUPERPHARM
12.5MG
25MG
UDL
12.5MG
25MG
VANGARD
12.5MG
25MG
WATSON LABS
12.5MG
12.5MG
TABLET, CHEWABLE; ORAL
ANTIVERT
PFIZER
25MG
MECLIZINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 25MG
NEXGEN PHARMA INC
25MG
PLIVA
25MG

A088732
A088734
A089113
A089114
A088256
A088257
A087877
A087620
A085195
A085269

001
001
001
001
001
001
001
001
001
001

Dec
Dec
Aug
Aug
Jun
Jun
Apr
Jan

11,
11,
20,
20,
13,
13,
20,
04,

1985
1985
1985
1985
1983
1983
1982
1982

N010721

005

A084976
A086392
A088733

001
001
001

1%

N050518

001

EQ 50MG BASE
EQ 100MG BASE

A071380
A071381

001
001

Jul 14, 1987

Jul 14, 1987

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

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

A071362
A071363
A072848
A072809
A072077
A072078
A072262
A072263
A071007
A071008
A071710
A071684
A070400
A071640
A070401
A071641

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Feb
Feb
Mar
Mar
Mar
Mar
Nov
Nov
Mar
Mar
Jun
Jun
Nov
Aug
Nov
Aug

EQ 50MG BASE
EQ 100MG BASE

N018006
N018006

001
002

100MG/ML

N012541

002

10MG

A083242

001

10MG

A085686

001

2.5MG

A081239

001

Dec 11, 1985

MECLOCYCLINE SULFOSALICYLATE
CREAM; TOPICAL
MECLAN
JOHNSON AND JOHNSON

MECLOFENAMATE SODIUM
CAPSULE; ORAL
MECLODIUM
QUANTUM PHARMICS
MECLOFENAMATE SODIUM
AM THERAP
BARR
PAR PHARM
SANDOZ
USL PHARMA
VITARINE
WATSON LABS

MECLOMEN
PARKE DAVIS

10,
10,
20,
20,
10,
10,
29,
29,
25,
25,
15,
15,
25,
11,
25,
11,

1987
1987
1989
1989
1988
1988
1988
1988
1988
1988
1988
1988
1986
1987
1986
1987

MEDROXYPROGESTERONE ACETATE
INJECTABLE; INJECTION
DEPO-PROVERA
PHARMACIA AND UPJOHN
TABLET; ORAL
AMEN
AMARIN PHARMS
CURRETAB
SOLVAY
CYCRIN
ESI

Oct 30, 1992

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6 - 214 (of 346)

MEDROXYPROGESTERONE ACETATE
TABLET; ORAL
CYCRIN
ESI

5MG
10MG
MEDROXYPROGESTERONE ACETATE
DURAMED PHARMS BARR
2.5MG
5MG
10MG

A081240
A089386

001
001

Oct 30, 1992

Sep 09, 1987

A040311
A040311
A040311

001
002
003

Dec 01, 1999

Dec 01, 1999
Dec 01, 1999

N016624

003

N019591

001

May 02, 1989

N019578

001

May 02, 1989

20MG
40MG

N016979
N016979

001
002

40MG
20MG
40MG

A074745
A070646
A070647

001
001
001

Feb 27, 1998

Oct 02, 1987
Oct 02, 1987

7.5MG
15MG
7.5MG
15MG
7.5MG
15MG

A077935
A077935
A077925
A077925
A077933
A077933

001
002
001
002
001
002

Jul
Jul
Jul
Jul
Jul
Jul

5MG
10MG

A090058
A090058

001
002

May 05, 2010

May 05, 2010

MEMANTINE HYDROCHLORIDE
DR REDDYS LABS LTD
5MG
10MG
TEVA PHARMS
5MG
10MG

A090048
A090048
A090052
A090052

001
002
001
002

Apr
Apr
Oct
Oct

10MG/ML

N005725

001

5MG/ML
10MG/ML
37.5MG/ML

N003718
N003718
N003718

004
006
008

MEDRYSONE
SUSPENSION; OPHTHALMIC
HMS
ALLERGAN

1%

MEFLOQUINE HYDROCHLORIDE
TABLET; ORAL
LARIAM
ROCHE
250MG
MEFLOQUINE HYDROCHLORIDE
US ARMY WALTER REED
250MG

MEGESTROL ACETATE
TABLET; ORAL
MEGACE
BRISTOL MYERS SQUIBB
MEGESTROL ACETATE
TEVA
USL PHARMA

MELOXICAM
TABLET; ORAL
MELOXICAM
MUTUAL PHARM
ROXANE
YABAO BIOPHARMS

19,
19,
19,
19,
19,
19,

2006
2006
2006
2006
2006
2006

MEMANTINE HYDROCHLORIDE
TABLET; ORAL
MEMANTINE
SUN PHARMA GLOBAL

MENADIOL SODIUM DIPHOSPHATE

INJECTABLE; INJECTION
KAPPADIONE
LILLY
SYNKAYVITE
ROCHE

14,
14,
25,
25,

2010
2010
2011
2011

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6 - 215 (of 346)

MENADIOL SODIUM DIPHOSPHATE

TABLET; ORAL
SYNKAYVITE
ROCHE

5MG

N003718

010

5MG

N002139

003

75 IU/VIAL;75 IU/VIAL
150 IU/VIAL;150 IU/VIAL

N020328
N020328

001
002

Sep 01, 1994

Sep 01, 1994

75 IU/VIAL;75 IU/VIAL
150 IU/VIAL;150 IU/VIAL

A073598
A073599

001
001

Jan 30, 1997

Jan 30, 1997

75 IU/AMP;75 IU/AMP
150 IU/AMP;150 IU/AMP

N017646
N017646

001
002

May 20, 1985

150 IU/VIAL;150 IU/VIAL

N021047

002

Aug 27, 1999

25MG/5ML

N010679

004

25MG/ML
50MG/ML
75MG/ML
100MG/ML

N005010
N005010
N005010
N005010

007
002
009
003

A080388
A080385
A080387
A080389
A080386
A089781
A089782
A089783
A089784
A089785
A089786
A089787
A089788
A088279
A088280
A088281
A088282
A086332
A080364
A080364
A080364

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
003
001

A040305
A040163

001
001

MENADIONE
TABLET; ORAL
MENADIONE
LILLY

MENOTROPINS (FSH;LH)
INJECTABLE; INJECTION
HUMEGON
ORGANON USA INC
MENOTROPINS
FERRING
PERGONAL
SERONO
REPRONEX
FERRING

MEPENZOLATE BROMIDE
SOLUTION; ORAL
CANTIL
SANOFI AVENTIS US

MEPERIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
DEMEROL
SANOFI AVENTIS US

MEPERIDINE HYDROCHLORIDE
ABBOTT
25MG/ML
50MG/ML
50MG/ML
75MG/ML
100MG/ML
ASTRAZENECA
25MG/ML
50MG/ML
50MG/ML
50MG/ML
75MG/ML
100MG/ML
100MG/ML
100MG/ML
BAXTER HLTHCARE
25MG/ML
50MG/ML
75MG/ML
100MG/ML
INTL MEDICATION
10MG/ML
PARKE DAVIS
50MG/ML
75MG/ML
100MG/ML
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
HOSPIRA
10MG/ML
MALLINCKRODT
10MG/ML

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Jun
Jun
Jun
Jun

31,
31,
31,
31,
31,
31,
31,
31,
15,
15,
15,
15,

1989
1989
1989
1989
1989
1989
1989
1989
1984
1984
1984
1984

Mar 10, 1999

May 12, 1997

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6 - 216 (of 346)

MEPERIDINE HYDROCHLORIDE
SYRUP; ORAL
DEMEROL
SANOFI AVENTIS US
50MG/5ML
TABLET; ORAL
MEPERIDINE HYDROCHLORIDE
DURAMED PHARMS BARR
50MG
100MG
MUTUAL PHARM
50MG
100MG
WYETH AYERST
50MG

N005010

005

A040318
A040318
A080448
A080448
A080454

001
002
001
002
001

25MG/ML;25MG/ML

N011730

001

EQ 15MG BASE/ML
EQ 30MG BASE/ML

N008248
N008248

002
001

100MG

N006008

001

A084777

002

N012125

003

A083559
A087509

001
001

N016053

002

N012455

002

N011284
N011284

001
002

A084030

001

A080380
A080380

001
002

N010028
N010028

005
004

N016069

001

Oct 05, 1999

Oct 05, 1999

MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

INJECTABLE; INJECTION
MEPERGAN
BAXTER HLTHCARE CORP

MEPHENTERMINE SULFATE
INJECTABLE; INJECTION
WYAMINE SULFATE
BAXTER HLTHCARE CORP

MEPHENYTOIN
TABLET; ORAL
MESANTOIN
NOVARTIS

MEPIVACAINE HYDROCHLORIDE
INJECTABLE; INJECTION
ARESTOCAINE HYDROCHLORIDE
SOLVAY
3%
CARBOCAINE
EASTMAN KODAK
3%
MEPIVACAINE HYDROCHLORIDE
GRAHAM CHEM
3%
INTL MEDICATION
1%

MEPREDNISONE
TABLET; ORAL
BETAPAR
SCHERING

4MG

MEPROBAMATE
CAPSULE; ORAL
EQUANIL
WYETH AYERST
400MG
CAPSULE, EXTENDED RELEASE; ORAL
MEPROSPAN
MEDPOINTE PHARM HLC
200MG
400MG
TABLET; ORAL
AMOSENE
FERNDALE LABS
400MG
BAMATE
ALRA
200MG
400MG
EQUANIL
WYETH AYERST
200MG
400MG
MEPRIAM
TEVA
400MG

Apr 18, 1982

Oct 05, 1982

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6 - 217 (of 346)

MEPROBAMATE
TABLET; ORAL
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
USL PHARMA
VALEANT PHARM INTL
VANGARD
WATSON LABS

WEST WARD
WHITEWORTH TOWN PLSN
MILTOWN
MEDPOINTE PHARM HLC

NEURAMATE
HALSEY

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
400MG
200MG
400MG
600MG
600MG
200MG
400MG
200MG
400MG

A084230
N015426
N015426
N016928
A084329
N014322
N014322
N015438
N015438
A084181
A084153
N014882
N014882
A086299
A089538
N015072
N014368
N014368
A080699
A080699
A083618
A084220
A084589
A084744
A084744
A084546
A084547
A084438
A084804
A084804
N014601
A084332
N014547
A080655
N014547
A083343
A084435
N014474
N014474
A083494
A087825
A087826
N015139
N015139
A088011
A085720
A085721
A084274
A085719
N015417
N015417
A083830
A083442

001
002
001
003
001
002
001
001
002
001
001
002
001
001
001
002
004
002
001
002
001
001
001
001
002
001
001
001
001
002
001
001
002
001
001
001
001
002
004
001
001
001
006
005
001
001
001
001
001
003
002
001
001

200MG
400MG
600MG

N009698
N009698
A083919

004
002
001

200MG
400MG

N014359
N014359

002
001

Nov 25, 1987

Mar 18, 1982

Mar 18, 1982

Jul 14, 1982

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DISCONTINUED DRUG PRODUCT LIST

6 - 218 (of 346)

MEPROBAMATE
TABLET; ORAL
TRANMEP
SOLVAY

400MG
400MG

A084369
N016249

001
001

100MG/ML;50MG/ML

A084875

001

500MG

N021252

001

Jan 05, 2001

500MG

N019919

001

Dec 18, 1990

EQ 25MG BASE/ML

N016997

001

EQ 25MG BASE/ML

N016775

001

EQ
EQ
EQ
EQ

N016774
N016774
N016774
N016774

001
002
003
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

A071540

001

Apr 12, 1988

A070759

001

Jul 01, 1988

N016725

001

N016709

001

N016715

002

MERSALYL SODIUM; THEOPHYLLINE

INJECTABLE; INJECTION
MERSALYL-THEOPHYLLINE
WATSON LABS

MESALAMINE
SUPPOSITORY; RECTAL
CANASA
AXCAN
ROWASA
ALAVEN PHARM

MESORIDAZINE BESYLATE
CONCENTRATE; ORAL
SERENTIL
NOVARTIS
INJECTABLE; INJECTION
SERENTIL
NOVARTIS
TABLET; ORAL
SERENTIL
NOVARTIS

10MG BASE
25MG BASE
50MG BASE
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
TABLET; ORAL-28
NORETHIN 1/50M-28
WATSON LABS
0.05MG;1MG
NORETHINDRONE AND MESTRANOL
WATSON LABS
0.05MG;1MG
NORINYL 1+80 28-DAY
GD SEARLE LLC
0.08MG;1MG
ORTHO-NOVUM 1/50 28
ORTHO MCNEIL JANSSEN 0.05MG;1MG
ORTHO-NOVUM 1/80 28
ORTHO MCNEIL PHARM
0.08MG;1MG

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6 - 219 (of 346)

MESTRANOL; NORETHYNODREL
TABLET; ORAL
ENOVID
GD SEARLE LLC
TABLET; ORAL-20
ENOVID
GD SEARLE LLC
ENOVID-E
GD SEARLE LLC
TABLET; ORAL-21
ENOVID-E 21
GD SEARLE LLC

0.075MG;5MG
0.15MG;9.85MG

N010976
N010976

008
005

0.075MG;5MG

N010976

004

0.1MG;2.5MG

N010976

006

0.1MG;2.5MG

N010976

007

N016402

001

N018761
N018761
N017659

002
001
001

Oct 10, 1986

Jun 30, 1983

A071275
A071018
A071806
A071805
A070805
A071855
A071726
A072190

001
001
001
001
001
001
001
001

Jul
Jul
Aug
Aug
Aug
Jul
Jul
Jun

A073340

001

Mar 30, 1992

N017571

001

A071656
A072761
A073034
A074702

001
001
001
001

Oct
Feb
Aug
Mar

A072023

001

Sep 15, 1988

N015874
N015874

002
001

A072054
A072055
A072519
A072520
A071013
A071014

001
001
001
001
001
001

Jun
Jun
Mar
Mar
Jan
Jan

EQ 10MG BASE/ML

N009509

002

Dec 22, 1987

EQ 10MG BASE/ML
EQ 10MG BASE/ML
EQ 10MG BASE/ML

A080431
A083363
A086418

001
001
001

METAPROTERENOL SULFATE
AEROSOL, METERED; INHALATION
ALUPENT
BOEHRINGER INGELHEIM 0.65MG/INH
SOLUTION; INHALATION
ALUPENT
BOEHRINGER INGELHEIM 0.4%
0.6%
5%
METAPROTERENOL SULFATE
ASTRAZENECA
0.4%
0.6%
DEY
0.33%
0.5%
5%
NEPHRON
0.4%
0.6%
WOCKHARDT
5%
PROMETA
MURO
5%
SYRUP; ORAL
ALUPENT
BOEHRINGER INGELHEIM 10MG/5ML
METAPROTERENOL SULFATE
MORTON GROVE
10MG/5ML
TEVA
10MG/5ML
TEVA PHARMS
10MG/5ML
WOCKHARDT
10MG/5ML
PROMETA
MURO
10MG/5ML
TABLET; ORAL
ALUPENT
BOEHRINGER INGELHEIM 10MG
20MG
METAPROTERENOL SULFATE
AM THERAP
10MG
20MG
TEVA
10MG
20MG
USL PHARMA
10MG
20MG

27,
27,
05,
05,
17,
14,
14,
07,

13,
27,
30,
24,

23,
23,
30,
30,
25,
25,

1988
1988
1988
1988
1987
1988
1988
1988

1987
1992
1991
1997

1988
1988
1990
1990
1988
1988

METARAMINOL BITARTRATE
INJECTABLE; INJECTION
ARAMINE
MERCK
METARAMINOL BITARTRATE
ABRAXIS PHARM
ELKINS SINN
GD SEARLE LLC

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6 - 220 (of 346)

METARAMINOL BITARTRATE
INJECTABLE; INJECTION
METARAMINOL BITARTRATE
GD SEARLE LLC

EQ 20MG BASE/ML

A086418

002

400MG

N013217

001

625MG
750MG

N020357
N020357

003
004

Nov 05, 1998

Nov 05, 1998

A075971
A075971
A075971
A078422
A078422
A078422
A075975
A075975
A075975
A075975
A075975
A076328
A076328
A076328

001
002
003
001
002
003
001
004
005
002
003
001
002
003

Jan
Jan
Jan
Aug
Aug
Aug
Jan
Jan
Jan
Jan
Jan
Dec
Dec
Dec

25,
25,
25,
06,
06,
06,
24,
24,
24,
24,
24,
16,
16,
16,

2002
2002
2002
2007
2007
2007
2002
2002
2002
2002
2002
2002
2002
2002

A076450
A076878
A076496
A076545
A077124
A076223

001
001
001
001
001
001

Oct
Apr
Nov
Dec
Dec
Dec

01,
13,
25,
01,
21,
14,

2004
2005
2005
2003
2005
2004

N021410

001

Oct 10, 2002

EQ 140MG BASE
EQ 280MG BASE

A060641
A060641

001
002

EQ 70MG BASE/5ML

A060641

003

N006134

004

A088108
A088109
A074081
A040241

001
001
001
001

METAXALONE
TABLET; ORAL
SKELAXIN
KING PHARMS

METFORMIN HYDROCHLORIDE
TABLET; ORAL
GLUCOPHAGE
BRISTOL MYERS SQUIBB

METFORMIN HYDROCHLORIDE
BARR
500MG
850MG
1GM
IPCA LABS LTD
500MG
850MG
1GM
IVAX SUB TEVA PHARMS 500MG
625MG
750MG
850MG
1GM
TEVA
500MG
850MG
1GM
TABLET, EXTENDED RELEASE; ORAL
METFORMIN HYDROCHLORIDE
ACTAVIS ELIZABETH
500MG
750MG
BARR
500MG
IVAX SUB TEVA PHARMS 500MG
MUTUAL PHARM
500MG
SANDOZ
500MG

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

TABLET; ORAL
AVANDAMET
SB PHARMCO

500MG;EQ 1MG BASE

METHACYCLINE HYDROCHLORIDE
CAPSULE; ORAL
RONDOMYCIN
MEDPOINTE PHARM HLC
SYRUP; ORAL
RONDOMYCIN
MEDPOINTE PHARM HLC

METHADONE HYDROCHLORIDE
SYRUP; ORAL
DOLOPHINE HYDROCHLORIDE
ROXANE
10MG/30ML
TABLET; ORAL
METHADONE HYDROCHLORIDE
ROXANE
5MG
10MG
40MG
SANDOZ
5MG

Mar
Mar
Apr
May

08,
08,
28,
29,

1983
1983
1995
1998

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DISCONTINUED DRUG PRODUCT LIST

6 - 221 (of 346)

METHADONE HYDROCHLORIDE
TABLET, DISPERSIBLE; ORAL
WESTADONE
SANDOZ
2.5MG
TABLET, EFFERVESCENT; ORAL
WESTADONE
SANDOZ
5MG
10MG
40MG

N017108

001

N017108
N017108
N017108

002
003
004

A083889

001

A040529
A084931
A084931
A086359

001
001
002
001

N005378
N005378
N005378

004
003
005

50MG

N007390

001

100MG

N008322

001

25MG
50MG
25MG
50MG

A040011
A040011
A040102
A040102

001
002
001
002

Jul
Jul
Aug
Aug

25MG
50MG

N011721
N011721

002
001

Nov 25, 1991

3.6MG

N011950

009

A087122

001

N011950

007

N011950

006

METHAMPHETAMINE HYDROCHLORIDE
TABLET; ORAL
METHAMPEX
TEVA
10MG
METHAMPHETAMINE HYDROCHLORIDE
ABLE
5MG
REXAR
5MG
10MG
TEVA
5MG
TABLET, EXTENDED RELEASE; ORAL
DESOXYN
LUNDBECK INC
5MG
10MG
15MG

Feb 25, 2004

METHANTHELINE BROMIDE
TABLET; ORAL
BANTHINE
SHIRE

METHARBITAL
TABLET; ORAL
GEMONIL
ABBOTT

METHAZOLAMIDE
TABLET; ORAL
METHAZOLAMIDE
APPLIED ANAL
SANDOZ
NEPTAZANE
LEDERLE

METHDILAZINE
TABLET, CHEWABLE; ORAL
TACARYL
WESTWOOD SQUIBB

METHDILAZINE HYDROCHLORIDE
SYRUP; ORAL
METHDILAZINE HYDROCHLORIDE
ALPHARMA US PHARMS
4MG/5ML
TACARYL
WESTWOOD SQUIBB
4MG/5ML
TABLET; ORAL
TACARYL
WESTWOOD SQUIBB
8MG

17,
17,
28,
28,

1997
1997
1996
1996

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DISCONTINUED DRUG PRODUCT LIST

6 - 222 (of 346)

METHICILLIN SODIUM
INJECTABLE; INJECTION
STAPHCILLIN
APOTHECON

A061449
N050117
A061449
N050117
A061449
N050117

001
001
002
002
003
003

15MG
20MG
20MG

A040619
A040547
A040350

003
004
003

5MG
10MG

N007517
N007517

002
004

1MG

N013420

001

100MG/ML

A089849

001

500MG

A085454

001

750MG

A085136

001

500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG

A040413
A040413
A089417
A089418
A087660
A087661
A085961
A085963
A084675
A084924
A084927
A084928
A085137
A084648
A084649
A085660
A085658
A084488
A084486
A084259
A084323
A085033
A088731
A089082
A084231
A084471
A085718
A085718

001
002
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
002

EQ
EQ
EQ
EQ
EQ
EQ

900MG
900MG
3.6GM
3.6GM
5.4GM
5.4GM

BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL
BASE/VIAL

METHIMAZOLE
TABLET; ORAL
METHIMAZOLE
CEDAR PHARMS
MYLAN
TAPAZOLE
KING PHARMS

Jul 12, 2005

Feb 18, 2005
Jun 07, 2001

METHIXENE HYDROCHLORIDE
TABLET; ORAL
TREST
NOVARTIS

METHOCARBAMOL
INJECTABLE; INJECTION
METHOCARBAMOL
MARSAM PHARMS LLC
TABLET; ORAL
DELAXIN
FERNDALE LABS
FORBAXIN
FOREST LABS
METHOCARBAMOL
ABLE
AM THERAP
ASCOT
CLONMEL HLTHCARE
HEATHER
IMPAX LABS
INWOOD LABS
IVAX SUB TEVA PHARMS
KV PHARM
MUTUAL PHARM
MYLAN
NYLOS
PIONEER PHARMS
PURACAP PHARM
PUREPAC PHARM

Dec 27, 1991

Mar
Mar
Feb
Feb
Oct
Oct

17,
17,
11,
11,
27,
27,

2003
2003
1987
1987
1982
1982

Dec 13, 1985

Dec 13, 1985

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DISCONTINUED DRUG PRODUCT LIST

6 - 223 (of 346)

METHOCARBAMOL
TABLET; ORAL
METHOCARBAMOL
ROXANE
SANDOZ
SOLCO HLTHCARE
SOLVAY
SUPERPHARM
TABLICAPS
UPSHER SMITH
WATSON LABS

500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
750MG
500MG
500MG
750MG
500MG
750MG

A088646
A088647
A087283
A087282
A086989
A086988
A084448
A084449
A087589
A087590
A084846
A087453
A087454
A083605
A083605

001
001
001
001
001
001
001
001
001
001
001
001
001
001
002

Feb 29, 1984

Feb 29, 1984

5GM/VIAL

N011559

003

EQ
EQ
EQ
EQ

25MG BASE/ML
50MG BASE/VIAL
100MG BASE/VIAL
250MG BASE/VIAL

A089161
A089354
A089355
A089356

001
001
001
001

Mar
Jul
Jul
Jul

10,
17,
17,
17,

1987
1987
1987
1987

EQ
EQ
EQ
EQ

25MG BASE/VIAL
50MG BASE/VIAL
100MG BASE/VIAL
250MG BASE/VIAL

A087695
A087695
A087695
A088954

001
002
003
001

Apr
Apr
Apr
Oct

08,
08,
08,
24,

1983
1983
1983
1985

A081242
A089180

001
001

Aug 23, 1991

Jan 03, 1986

N011719

007

Mar 31, 1982

A040265
A040266
N011719
N011719
N011719

001
001
014
013
011

Feb
Feb
Apr
Apr
Apr

26,
26,
13,
13,
13,

1999
1999
2005
2005
2005

A089323
A088935
A089263
A089322
A088936
A088937
N011719
N011719
N011719
N011719
N011719
A088648
A089158

001
001
001
001
001
001
004
001
005
003
006
001
001

Jun
Oct
Jun
Jun
Oct
Oct

13,
11,
13,
13,
11,
11,

1986
1985
1986
1986
1985
1985

N011719

009

Apr 07, 1988

Jan 22, 1982

Jan 22, 1982

METHOHEXITAL SODIUM
INJECTABLE; INJECTION
BREVITAL SODIUM
JHP PHARMS

METHOTREXATE SODIUM
INJECTABLE; INJECTION
ABITREXATE
ABIC

FOLEX
PHARMACIA AND UPJOHN

FOLEX PFS
PHARMACIA AND UPJOHN

EQ 25MG BASE/ML
EQ 25MG BASE/ML

METHOTREXATE LPF
HOSPIRA
EQ 25MG BASE/ML
METHOTREXATE PRESERVATIVE FREE
APP PHARMS
EQ 25MG BASE/ML
EQ 1GM BASE/VIAL
HOSPIRA
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
EQ 500MG BASE/20ML (EQ 25MG BASE/ML)
EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)
METHOTREXATE SODIUM
ABRAXIS PHARM
EQ 2.5MG BASE/ML
EQ 20MG BASE/VIAL
EQ 25MG BASE/ML
EQ 25MG BASE/ML
EQ 50MG BASE/VIAL
EQ 100MG BASE/VIAL
HOSPIRA
EQ 2.5MG BASE/ML
EQ 20MG BASE/VIAL
EQ 25MG BASE/ML
EQ 50MG BASE/VIAL
EQ 100MG BASE/VIAL
NORBROOK
EQ 25MG BASE/ML
PHARMACHEMIE USA
EQ 25MG BASE/ML
METHOTREXATE SODIUM PRESERVATIVE FREE
HOSPIRA
EQ 1GM BASE/VIAL

May 09, 1986

Jul 08, 1988

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6 - 224 (of 346)

METHOTREXATE SODIUM
INJECTABLE; INJECTION
MEXATE
BRISTOL

MEXATE-AQ
BRISTOL MYERS
MEXATE-AQ PRESERVED
BRISTOL MYERS SQUIBB
TABLET; ORAL
METHOTREXATE SODIUM
DURAMED PHARMS BARR

EQ
EQ
EQ
EQ

20MG BASE/VIAL
50MG BASE/VIAL
100MG BASE/VIAL
250MG BASE/VIAL

A086358
A086358
A086358
A086358

001
002
003
004

EQ 25MG BASE/ML

A088760

001

Feb 14, 1985

EQ 25MG BASE/ML

A089887

001

Apr 14, 1989

EQ 2.5MG BASE

A040233

001

Jun 17, 1999

10MG/ML
20MG/ML

N006772
N006772

002
001

10MG

A087781

001

A080970

001

5MG

N017364

001

2.5MG
5MG
2.5MG
2.5MG
5MG
2.5MG
5MG
5MG
2.5MG
2.5MG
5MG

A087913
A087786
A087671
A089135
A089136
A089835
A089837
A088745
A085487
A088750
A085476

001
001
001
001
001
001
001
001
001
001
001

N016047

001

2.5MG;0.1MG

N012708

005

250MG/5ML

N018389

001

METHOXAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
VASOXYL
GLAXOSMITHKLINE

METHOXSALEN
CAPSULE; ORAL
METHOXSALEN
SANDOZ

Jun 08, 1982

METHSCOPOLAMINE BROMIDE
TABLET; ORAL
METHSCOPOLAMINE BROMIDE
PVT FORM
2.5MG

METHYCLOTHIAZIDE
TABLET; ORAL
AQUATENSEN
MEDPOINTE PHARM HLC
METHYCLOTHIAZIDE
IVAX PHARMS
MYLAN
PAR PHARM
SANDOZ
USL PHARMA
WATSON LABS

METHYCLOTHIAZIDE; PARGYLINE HYDROCHLORIDE

TABLET; ORAL
EUTRON
ABBOTT

5MG;25MG

METHYCLOTHIAZIDE; RESERPINE
TABLET; ORAL
DIUTENSEN-R
MEDPOINTE PHARM HLC

METHYLDOPA
SUSPENSION; ORAL
ALDOMET
MERCK

Jun
May
Aug
Feb
Feb
Aug
Aug
Mar
Mar
Sep
Mar

03,
18,
17,
12,
12,
18,
18,
21,
11,
06,
11,

1982
1982
1982
1986
1986
1988
1988
1985
1982
1984
1982

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DISCONTINUED DRUG PRODUCT LIST

6 - 225 (of 346)

METHYLDOPA
TABLET; ORAL
ALDOMET
MERCK

METHYLDOPA
ACCORD HLTH
DURAMED PHARMS BARR
HALSEY

MUTUAL PHARM

PAR PHARM

PARKE DAVIS

PLIVA

PUREPAC PHARM

ROXANE

SANDOZ

SUPERPHARM
TEVA

WATSON LABS

125MG
250MG
500MG

N013400
N013400
N013400

003
001
002

125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
125MG
250MG
500MG
250MG
500MG
125MG
250MG
500MG
125MG
125MG
250MG
250MG
250MG
500MG
500MG

A070070
A071006
A071009
A071751
A071752
A071753
A070073
A070060
A070074
A070535
A070536
A070537
A070331
A070332
A070333
A072126
A072127
A072128
A070749
A070750
A070452
A070192
A070193
A070194
A071700
N018934
N018934
A070669
A070670
A071105
A071106
A071067
A070245
A070260
A070246
A070261
A070703
A070247
A070262

003
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001
001
001
001

N013401

001

A070652
A070291
A070691
A070698
A070699
A070849
A071812
A070841

001
001
001
001
001
001
001
001

Oct
Dec
Dec
Mar
Mar
Mar
Oct
Oct
Oct
Jan
Jan
Jan
Apr
Apr
Apr
Jul
Jul
Jul
Feb
Feb
Feb
Apr
Apr
Apr
Mar
Jun
Jun
Jun
Jun
Dec
Dec
Dec
Feb
Jun
Feb
Jun
Jun
Feb
Jun

15,
16,
16,
28,
28,
28,
09,
09,
09,
02,
02,
02,
15,
15,
15,
07,
07,
07,
07,
07,
07,
25,
25,
25,
02,
29,
29,
23,
23,
05,
05,
05,
25,
24,
25,
24,
06,
25,
24,

1985
1986
1986
1988
1988
1988
1986
1986
1986
1987
1987
1987
1986
1986
1986
1988
1988
1988
1986
1986
1986
1986
1986
1986
1988
1984
1984
1989
1989
1986
1986
1986
1986
1985
1986
1985
1986
1986
1985

Jun
Jul
Jun
Jun
Jun
Jun
Dec
Jan

03,
01,
19,
15,
15,
19,
22,
02,

1986
1986
1987
1987
1987
1987
1987
1987

METHYLDOPATE HYDROCHLORIDE
INJECTABLE; INJECTION
ALDOMET
MERCK
50MG/ML
METHYLDOPATE HYDROCHLORIDE
ABRAXIS PHARM
50MG/ML
BAXTER HLTHCARE
50MG/ML
HOSPIRA
50MG/ML
50MG/ML
50MG/ML
50MG/ML
MARSAM PHARMS LLC
50MG/ML
SMITH AND NEPHEW
50MG/ML

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DISCONTINUED DRUG PRODUCT LIST

6 - 226 (of 346)

METHYLPHENIDATE HYDROCHLORIDE
TABLET; ORAL
METHYLPHENIDATE HYDROCHLORIDE
ABLE
5MG
10MG
20MG
ACTAVIS ELIZABETH
5MG
10MG
20MG
TABLET, EXTENDED RELEASE; ORAL
METHYLPHENIDATE HYDROCHLORIDE
ABLE
20MG
ACTAVIS ELIZABETH
20MG

A040404
A040404
A040404
A040321
A040321
A040321

001
002
003
001
002
003

Mar
Mar
Mar
Feb
Feb
Feb

29,
29,
29,
05,
05,
05,

2001
2001
2001
2002
2002
2002

A076032
A075450

001
001

May 09, 2001

Dec 21, 2001

2MG
24MG

N011153
N011153

002
005

4MG
16MG
24MG
32MG
4MG
4MG
16MG

A085650
A089207
A089208
A089209
A087341
A086161
A086159

001
001
001
001
001
001
001

N018102

001

A086903
A086903
A085597
A087248
A085374
A085600
A085595
A086507

001
002
001
001
001
001
001
001

A086666
A087135

001
001

N012421
N012421

001
002

A060611
A060611

002
001

A089573
A089574
A089575
A089576

001
001
001
001

METHYLPREDNISOLONE
TABLET; ORAL
MEDROL
PHARMACIA AND UPJOHN
METHYLPREDNISOLONE
HEATHER
PAR PHARM

SANDOZ
WATSON LABS

Apr 25, 1988

Apr 25, 1988
Apr 25, 1988
Feb 09, 1982
Feb 09, 1982

METHYLPREDNISOLONE ACETATE
ENEMA; RECTAL
MEDROL
PHARMACIA AND UPJOHN 40MG/BOT
INJECTABLE; INJECTION
METHYLPREDNISOLONE ACETATE
AKORN
40MG/ML
80MG/ML
WATSON LABS
20MG/ML
20MG/ML
40MG/ML
40MG/ML
80MG/ML
80MG/ML
M-PREDROL
BEL MAR
40MG/ML
80MG/ML
OINTMENT; TOPICAL
MEDROL ACETATE
PHARMACIA AND UPJOHN 0.25%
1%

Oct 20, 1982

Oct 20, 1982

METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE

CREAM; TOPICAL
NEO-MEDROL ACETATE
PHARMACIA AND UPJOHN

0.25%;EQ 3.5MG BASE/GM

1%;EQ 3.5MG BASE/GM

METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE; INJECTION
A-METHAPRED
ABBOTT

EQ
EQ
EQ
EQ

40MG BASE/VIAL
125MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL

Feb
Feb
Feb
Feb

22,
22,
22,
22,

1991
1991
1991
1991

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6 - 227 (of 346)

METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE; INJECTION
A-METHAPRED
HOSPIRA

EQ
EQ
EQ
EQ
EQ
EQ

40MG BASE/VIAL
125MG BASE/VIAL
500MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1GM BASE/VIAL

A085853
A085855
A085854
A089173
A085852
A089174

001
001
001
001
001
001

EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
ORGANON USA INC
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
METHYLPREDNISOLONE SODIUM SUCCINATE
ABRAXIS PHARM
EQ 40MG BASE/VIAL
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
ELKINS SINN
EQ 40MG BASE/VIAL
INTL MEDICATION
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
TEVA PARENTERAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
WATSON LABS
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL

A086906
A086906
A086906
A087535
A087535

002
003
004
001
002

A088676
A089143
A088677
A089144
A088678
A089186
A089187
A088679
A089188
A089189
A086906
A087812
A087813
A087851
A087852
A081267
A081268
A086953
A087030
A088523
A088524

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

0.1%;EQ 3.5MG BASE/GM

A060645

001

10MG

A084967

001

10MG

A087750

001

5MG

A087222

001

10MG

A080281

001

5MG
10MG

N003240
N003240

004
005

10MG
10MG
10MG
10MG

A084287
A080256
A080308
A080475

001
001
001
001

METHYLPREDNISOLONE
ELKINS SINN

Aug 18, 1987

Aug 18, 1987

Jun 25, 1982

Jun 25, 1982
Jun
Mar
Jun
Mar
Jun
Mar
Mar
Jun
Mar
Mar

08,
28,
08,
28,
08,
28,
28,
08,
28,
28,

1984
1986
1984
1986
1984
1986
1986
1984
1986
1986

Feb
Feb
Feb
Feb
Nov
Nov
Jul
Jul
Jul
Jul

09,
09,
09,
09,
30,
30,
22,
22,
24,
24,

1983
1983
1983
1983
1992
1992
1982
1982
1984
1984

METHYLPREDNISOLONE; NEOMYCIN SULFATE

OINTMENT; OPHTHALMIC
NEO-MEDROL
PHARMACIA AND UPJOHN

METHYLTESTOSTERONE
CAPSULE; ORAL
METHYLTESTOSTERONE
HEATHER
VIRILON
STAR PHARMS FL
TABLET; BUCCAL
ANDROID 5
VALEANT PHARM INTL
ORETON
SCHERING
TABLET; BUCCAL/SUBLINGUAL
METANDREN
NOVARTIS
METHYLTESTOSTERONE
IMPAX LABS
LILLY
PUREPAC PHARM

Nov 24, 1982

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6 - 228 (of 346)

METHYLTESTOSTERONE
TABLET; BUCCAL/SUBLINGUAL
METHYLTESTOSTERONE
PVT FORM
TABLICAPS
USL PHARMA
TABLET; ORAL
METANDREN
NOVARTIS
METHYLTESTOSTERONE
INWOOD LABS
KV PHARM
LANNETT
LILLY
PARKE DAVIS
PUREPAC PHARM

PVT FORM

TABLICAPS
WATSON LABS
WEST WARD

ORETON METHYL
SCHERING

5MG
10MG
10MG

A083836
A085125
A080271

001
001
001

10MG
25MG

N003240
N003240

001
003

10MG
25MG
10MG
10MG
25MG
25MG
10MG
25MG
10MG
10MG
25MG
25MG
5MG
10MG
25MG
10MG
25MG
10MG
25MG
10MG
25MG
25MG

A080839
A080973
A084312
A087092
A087111
A080256
A084244
A084241
A080309
A080475
A080310
A080475
A080214
A080214
A080214
A080313
A085270
A080933
A080931
A084331
A084331
A084642

001
001
001
001
001
002
001
001
001
002
001
003
001
002
003
001
001
001
001
001
002
001

10MG
25MG

N003158
N003158

001
002

300MG

N009660

008

50MG/5ML

N009660

007

50MG
200MG

N009660
N009660

002
004

2MG

N012516

001

A072995

001

Jan 30, 1992

A072155
A072244
A072247
A070505

001
001
001
001

Mar
Mar
May
Jun

Nov 05, 1982

Jan 27, 1983

METHYPRYLON
CAPSULE; ORAL
NOLUDAR
ROCHE
ELIXIR; ORAL
NOLUDAR
ROCHE
TABLET; ORAL
NOLUDAR
ROCHE

METHYSERGIDE MALEATE
TABLET; ORAL
SANSERT
NOVARTIS

METOCLOPRAMIDE HYDROCHLORIDE
CONCENTRATE; ORAL
METOCLOPRAMIDE INTENSOL
ROXANE
EQ 10MG BASE/ML
INJECTABLE; INJECTION
METOCLOPRAMIDE HYDROCHLORIDE
BEDFORD
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
HOSPIRA
EQ 5MG BASE/ML

30,
30,
18,
23,

1992
1992
1992
1989

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6 - 229 (of 346)

METOCLOPRAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION
METOCLOPRAMIDE HYDROCHLORIDE
HOSPIRA
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
LYPHOMED
EQ 10MG BASE/2ML
NORBROOK
EQ 10MG BASE/2ML
SMITH AND NEPHEW
EQ 5MG BASE/ML
EQ 10MG BASE/2ML
REGLAN
BAXTER HLTHCARE CORP EQ 10MG BASE/ML
SOLUTION; ORAL
METOCLOPRAMIDE HYDROCHLORIDE
ACTAVIS MID ATLANTIC EQ 5MG BASE/5ML
MORTON GROVE
EQ 5MG BASE/5ML
PACO
EQ 5MG BASE/5ML
ROXANE
EQ 5MG BASE/5ML
TEVA
EQ 5MG BASE/5ML
EQ 5MG BASE/5ML
REGLAN
ROBINS AH
EQ 5MG BASE/5ML
TABLET; ORAL
CLOPRA
QUANTUM PHARMICS
EQ 5MG BASE
EQ 10MG BASE
CLOPRA-"YELLOW"
QUANTUM PHARMICS
EQ 10MG BASE
MAXOLON
KING PHARMS
EQ 10MG BASE
METOCLOPRAMIDE HYDROCHLORIDE
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
REGLAN ODT
MEDA PHARMS
EQ 5MG BASE
EQ 10MG BASE

A070506
A070847
A071291
A071990
A073117
A074147
A070293
A070892
A070623
A070622

001
001
001
001
001
001
001
001
001
001

Jun
Nov
Mar
Jan
Jan
Aug
Jan
Aug
Mar
Mar

N017862

004

May 28, 1987

A071340
A070949
A071665
A072038
A070819
A071315

001
001
001
001
001
001

Aug
Mar
Dec
Dec
Jul
Jun

N018821

001

Mar 25, 1983

A072384
A070294

001
001

Jun 02, 1988

Jul 29, 1985

A070632

001

Oct 28, 1985

A070106

001

Mar 04, 1986

A072639
A070906
A071213
A070660
A071536
A070342
A072436
A074478
A070850
A072215
A074478
A070598
A070926
A070339
A070363
A070453
A070511
A070645

001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001

May
Oct
Sep
Feb
Apr
Mar
Jun
Oct
Feb
Jan
Oct
Feb
Jun
Jul
Mar
Jun
Jan
May

N021793
N021793

001
002

Jun 10, 2005

Jun 10, 2005

N006632

003

METOCURINE IODIDE
INJECTABLE; INJECTION
METUBINE IODIDE
LILLY

2MG/ML

22,
07,
03,
18,
17,
02,
24,
26,
02,
02,

18,
06,
05,
05,
10,
30,

09,
28,
24,
10,
28,
25,
22,
05,
03,
30,
05,
02,
26,
29,
02,
06,
22,
11,

1989
1988
1989
1989
1991
1996
1986
1988
1987
1987

1988
1987
1988
1988
1987
1993

1991
1986
1986
1987
1993
1986
1989
1995
1987
1990
1995
1987
1987
1985
1987
1986
1986
1987

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METOLAZONE
TABLET; ORAL
DIULO
GD SEARLE LLC

METOLAZONE
ROXANE
WATSON LABS
MYKROX
UCB INC

2.5MG
5MG
10MG

N018535
N018535
N018535

001
002
003

10MG
10MG

A076482
A076891

002
001

Apr 29, 2004

Jul 21, 2004

0.5MG

N019532

001

Oct 30, 1987

N019786
N019786
N019786
N019786

001
002
003
004

Dec
Dec
Dec
Dec

27,
27,
27,
27,

1989
1989
1989
1989

50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG

A074258
A074258
A073666
A073666
A074380
A074380
A074453
A074453
A074143
A074143
A074333
A074333

001
002
001
002
001
002
001
002
001
002
001
002

Jan
Jan
Dec
Dec
Jul
Jul
Apr
Apr
Sep
Sep
Jan
Jan

27,
27,
21,
21,
29,
29,
27,
27,
30,
30,
27,
27,

1994
1994
1993
1993
1994
1994
1995
1995
1994
1994
1994
1994

2.5GM/VIAL
3.75GM/VIAL
6.75GM/VIAL
13.5GM/VIAL

N017982
N017982
N017982
N017982

003
001
002
004

Sep 12, 1983

375MG

A076505

001

Nov 13, 2003

500MG/100ML

N018674

001

Aug 31, 1982

500MG/100ML
500MG/100ML
500MG/100ML
500MG/100ML
500MG/100ML
500MG/100ML

N018889
A070071
N018907
A070004
A070042
A070170

001
001
001
001
001
001

Nov
Dec
Mar
May
Dec
Apr

250MG
500MG

A074523
A074523

001
002

Oct 24, 1996

Oct 24, 1996

METOPROLOL FUMARATE
TABLET, EXTENDED RELEASE; ORAL
LOPRESSOR
NOVARTIS
EQ 100MG
EQ 200MG
EQ 300MG
EQ 400MG

TARTRATE
TARTRATE
TARTRATE
TARTRATE

METOPROLOL TARTRATE
TABLET; ORAL
METOPROLOL TARTRATE
APOTHECON
MYLAN
PUREPAC PHARM
SOLCO HLTHCARE
TEVA
TEVA PHARMS

METRIZAMIDE
INJECTABLE; INJECTION
AMIPAQUE
GE HEALTHCARE

Sep 12, 1983

METRONIDAZOLE
CAPSULE; ORAL
METRONIDAZOLE
ABLE
INJECTABLE; INJECTION
METRO I.V.
B BRAUN
METRONIDAZOLE
ABBOTT
ABRAXIS PHARM
ELKINS SINN
INTL MEDICATION
WATSON LABS
TABLET; ORAL
METROMIDOL
LABS AF

18,
03,
30,
08,
20,
01,

1983
1984
1984
1985
1984
1986

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6 - 231 (of 346)

METRONIDAZOLE
TABLET; ORAL
METRONIDAZOLE
ABLE

250MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG

A076519
A076519
A070021
A070593
N018517
N018517
N019029
N018818
N018818
N018845
N018930
N018620
N018740
N018620
N018740
A070008
A070009
N018599
N018599
A070040
A070039

001
002
001
001
001
002
001
001
002
001
001
001
001
002
002
001
001
001
002
001
001

Jun
Jun
Apr
Feb

27,
27,
02,
27,

2003
2003
1985
1986

May
Apr
Feb
Feb
Aug
Aug
Mar
Oct
Jun
Oct
Dec
Dec
Sep
Feb
Jan
Jan

05,
10,
16,
16,
18,
18,
04,
22,
02,
22,
11,
11,
17,
13,
29,
29,

1982
1984
1983
1983
1983
1983
1982
1982
1983
1982
1984
1984
1982
1984
1985
1985

250MG
500MG

N018871
N018871

001
002

Mar 02, 1983

Mar 02, 1983

250MG
500MG
TABLET, EXTENDED RELEASE; ORAL
METRONIDAZOLE
ABLE
750MG

A070029
A070731

001
001

Mar 19, 1985

Jun 08, 1987

A076462

001

Jun 25, 2003

N018353

001

A070295

001

N012911

001

A074450
A074450
A074450

001
002
003

May 16, 1996

May 16, 1996
May 16, 1996

N018873
N018873
N018873

002
003
004

Dec 30, 1985

Dec 30, 1985
Dec 30, 1985

A062333
A062372
N050549

001
005
001

Jan 13, 1983

HALSEY
IVAX SUB TEVA PHARMS
LNK
MUTUAL PHARM
PAR PHARM
SANDOZ

SUPERPHARM
WATSON LABS
WORLD GEN
PROTOSTAT
ORTHO MCNEIL PHARM
SATRIC
SAVAGE LABS

METRONIDAZOLE HYDROCHLORIDE
INJECTABLE; INJECTION
FLAGYL I.V.
PFIZER
EQ 500MG BASE/VIAL
METRONIDAZOLE HYDROCHLORIDE
ABRAXIS PHARM
EQ 500MG BASE/VIAL

Oct 15, 1985

METYRAPONE
TABLET; ORAL
METOPIRONE
NOVARTIS

250MG

MEXILETINE HYDROCHLORIDE
CAPSULE; ORAL
MEXILETINE HYDROCHLORIDE
SANDOZ
150MG
200MG
250MG
MEXITIL
BOEHRINGER INGELHEIM 150MG
200MG
250MG

MEZLOCILLIN SODIUM MONOHYDRATE

INJECTABLE; INJECTION
MEZLIN
BAYER PHARMS

EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL

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6 - 232 (of 346)

MEZLOCILLIN SODIUM MONOHYDRATE

INJECTABLE; INJECTION

MEZLIN

BAYER PHARMS

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

2GM BASE/VIAL
2GM BASE/VIAL
2GM BASE/VIAL
3GM BASE/VIAL
3GM BASE/VIAL
3GM BASE/VIAL
3GM BASE/VIAL
4GM BASE/VIAL
4GM BASE/VIAL
4GM BASE/VIAL
4GM BASE/VIAL
20GM BASE/VIAL
20GM BASE/VIAL

A062333
A062372
N050549
A062333
A062372
A062697
N050549
A062333
A062372
A062697
N050549
A062372
N050549

002
001
002
003
002
001
003
004
003
002
004
004
005

N018040

001

N017494

001

A074136
A074030

001
001

Jan 04, 1995

Oct 30, 1992

A074586

001

Jul 17, 1997

N017739

001

N018592

001

Oct 27, 1989

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

A075620
A075620
A075641
A075263
A075249
A075455
A075396
A075396
A075484
A075409
A075409

001
002
001
001
001
001
001
002
001
002
001

Nov
Nov
Oct
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

1MG BASE/ML
5MG BASE/ML

N018654
N018654

002
001

May 26, 1987

Dec 20, 1985

2MG BASE/ML

N020942

001

Oct 15, 1998

May 13, 1982

May 13, 1982

Jan 22, 1987

May 13, 1982

Jan 22, 1987
Mar 02, 1988
Mar 02, 1988

MICONAZOLE
INJECTABLE; INJECTION
MONISTAT
JANSSEN PHARMA

10MG/ML

MICONAZOLE NITRATE
CREAM; TOPICAL
MONISTAT-DERM
INSIGHT PHARMS
2%
CREAM; VAGINAL
MICONAZOLE NITRATE
TEVA
2%
TEVA PHARMS
2%
CREAM, SUPPOSITORY; TOPICAL, VAGINAL
M-ZOLE 7 DUAL PACK
ACTAVIS MID ATLANTIC 2%,100MG
LOTION; TOPICAL
MONISTAT-DERM
INSIGHT PHARMS
2%
TAMPON; VAGINAL
MONISTAT 5
PERSONAL PRODS
100MG

MIDAZOLAM HYDROCHLORIDE
INJECTABLE; INJECTION
MIDAZOLAM HYDROCHLORIDE
APOTHECON
EQ
EQ
EQ
ASTRAZENECA
EQ
BEDFORD
EQ
BEN VENUE
EQ
HOSPIRA
EQ
EQ
EQ
HOSPIRA INC
EQ
EQ
VERSED
HLR
EQ
EQ
SYRUP; ORAL
VERSED
ROCHE
EQ

1MG
5MG
5MG
5MG
5MG
5MG
1MG
5MG
5MG
1MG
5MG

01,
01,
19,
26,
23,
20,
20,
20,
20,
20,
20,

2000
2000
2000
2000
2000
2000
2000
2000
2000
2000
2000

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6 - 233 (of 346)

MILRINONE LACTATE
INJECTABLE; INJECTION
MILRINONE LACTATE
BAXTER HLTHCARE CORP
BIONICHE PHARMA
HOSPIRA

EQ 1MG BASE/ML
EQ 1MG BASE/ML
EQ 1MG BASE/ML
EQ 1MG BASE/ML
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
PRIMACOR
SANOFI AVENTIS US
EQ 1MG BASE/ML
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
SANOFI AVENTIS US
EQ 10MG BASE/100ML
EQ 15MG BASE/100ML
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

A075852
A076428
A075830
A075884

001
001
001
001

May
Jun
May
May

28,
16,
28,
28,

A075510
A076259

001
001

May 28, 2002

Aug 08, 2002

N019436

001

Dec 31, 1987

N020343
N020343
N020343
N020343

001
002
003
004

Aug
Aug
Aug
Aug

EQ 50MG BASE

A063066

001

Aug 14, 1990

EQ 50MG BASE
EQ 100MG BASE
EQ 75MG BASE

N050315
N050315
N050649

002
001
003

Feb 12, 2001

A062139

001

N050445

001

N050451
N050451

003
002

Aug 10, 1982

Aug 10, 1982

A091424

002

Nov 30, 2011

2%
2%
2%
2%

A074643
A074500
A074743
A074589

001
001
002
001

Apr
May
Oct
Apr

2%

A074743

001

Oct 18, 1996

2.5MG
10MG

N018154
N018154

001
003

2.5MG
10MG

A072153
A071534

001
001

Jul 13, 1988

Mar 19, 1987

2.5MG
10MG
2.5MG

A071799
A071796
A071537

001
001
001

Nov 10, 1987

Nov 10, 1987
Dec 16, 1988

09,
09,
09,
09,

2002
2003
2002
2002

1994
1994
1994
1994

MINOCYCLINE HYDROCHLORIDE
CAPSULE; ORAL
DYNACIN
MEDICIS
MINOCIN
TRIAX PHARMS

TRIAX PHARMS LLC

INJECTABLE; INJECTION
MINOCIN
LEDERLE
EQ 100MG BASE/VIAL
SUSPENSION; ORAL
MINOCIN
TRIAX PHARMS
EQ 50MG BASE/5ML
TABLET; ORAL
MINOCYCLINE HYDROCHLORIDE
TRIAX PHARMS
EQ 50MG BASE
EQ 100MG BASE
TABLET, EXTENDED RELEASE; ORAL
MINOCYCLINE HYDROCHLORIDE
LUPIN LTD
EQ 55MG BASE

MINOXIDIL
SOLUTION; TOPICAL
MINOXIDIL (FOR MEN)
BAUSCH AND LOMB
COPLEY PHARM
SIGHT PHARMS
TEVA
MINOXIDIL (FOR WOMEN)
SIGHT PHARMS
TABLET; ORAL
LONITEN
PHARMACIA AND UPJOHN
MINODYL
QUANTUM PHARMICS
MINOXIDIL
ROYCE LABS
USL PHARMA

09,
23,
18,
05,

1996
1996
1996
1996

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6 - 234 (of 346)

MIRTAZAPINE
TABLET; ORAL
MIRTAZAPINE
ACTAVIS ELIZABETH

15MG
30MG
45MG
ACTAVIS TOTOWA
15MG
30MG
45MG
IVAX SUB TEVA PHARMS 15MG
30MG
45MG
ROXANE
15MG
30MG
45MG
SANDOZ
15MG
30MG
45MG
TABLET, ORALLY DISINTEGRATING; ORAL
MIRTAZAPINE
ACTAVIS TOTOWA
15MG
30MG
45MG

A076308
A076308
A076308
A076241
A076241
A076241
A076244
A076244
A076244
A076270
A076270
A076270
A076189
A076189
A076189

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Jun
Jun
Jun
Jun
Jun
Jun
Dec
Dec
Dec
Jun
Jun
Jun
Jun
Jun
Jun

20,
20,
20,
25,
25,
25,
22,
22,
22,
19,
19,
19,
19,
19,
19,

2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003

A076689
A076689
A076689

001
002
003

Aug 31, 2005

Aug 31, 2005
Aug 31, 2005

20MG/VIAL

A064106

001

Nov 29, 1995

5MG/VIAL

N050763

001

Nov 14, 2002

5MG/VIAL
20MG/VIAL
5MG/VIAL
20MG/VIAL
40MG/VIAL

N050450
N050450
A062336
A062336
A062336

001
002
001
002
003

Mar 10, 1988

N019297
N019297
N019297

001
002
003

Dec 23, 1987

Dec 23, 1987
Dec 23, 1987

2MG BASE/ML
PLASTIC CONTAINER
0.5MG BASE/ML
50MG BASE/100ML

N020098

001

Jan 22, 1992

N020098
N020098

002
003

Jan 22, 1992

Jan 22, 1992

2MG BASE/ML

A078562

001

Apr 30, 2009

5MG
10MG
25MG

N017111
N017111
N017111

001
002
003

20MG/ML

N017938

001

MITOMYCIN
INJECTABLE; INJECTION
MITOMYCIN
HOSPIRA
MITOZYTREX
SUPERGEN
MUTAMYCIN
BRISTOL
BRISTOL MYERS

MITOXANTRONE HYDROCHLORIDE
INJECTABLE; INJECTION
NOVANTRONE
EMD SERONO

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)

MIVACURIUM CHLORIDE
INJECTABLE; INJECTION
MIVACRON
ABBOTT
EQ
MIVACRON IN DEXTROSE 5% IN
ABBOTT
EQ
EQ
MIVACURIUM CHLORIDE
PISGAH LABS
EQ

MOLINDONE HYDROCHLORIDE
CAPSULE; ORAL
MOBAN
ENDO PHARMS

CONCENTRATE; ORAL
MOBAN
ENDO PHARMS

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6 - 235 (of 346)

MOLINDONE HYDROCHLORIDE
TABLET; ORAL
MOBAN
ENDO PHARMS

5MG
10MG
25MG
50MG
100MG

N017111
N017111
N017111
N017111
N017111

004
005
006
007
008

20%

N008173

003

N019368

001

Oct 29, 1985

N019753
N019753
N019753

001
002
003

Jun 19, 1990

Jun 19, 1990
Jun 19, 1990

N019917
N020631
N020631

001
001
002

Oct 30, 1992

Jul 03, 1996
Jul 03, 1996

N021671
N021671

002
003

May 18, 2004

May 18, 2004

A075656

001

Jan 30, 2001

N050550
N050550
N050550
N050550
N050550

001
002
003
004
008

500MG

A090464

001

Sep 13, 2010

500MG
750MG
750MG
500MG
750MG

A079093
A079093
A075179
A075590
A075590

001
002
001
001
002

Feb
Feb
Jun
Feb
Feb

MONOBENZONE
CREAM; TOPICAL
BENOQUIN
VALEANT PHARM INTL

MONOCTANOIN
LIQUID; PERFUSION, BILIARY
MOCTANIN
ETHITEK
100%

MORICIZINE HYDROCHLORIDE
TABLET; ORAL
ETHMOZINE
SHIRE

200MG
250MG
300MG

MORPHINE SULFATE
INJECTABLE; INJECTION
MORPHINE SULFATE
HOSPIRA
MALLINCKRODT

0.5MG/ML
1MG/ML
2MG/ML
INJECTABLE, LIPOSOMAL; EPIDURAL
DEPODUR
EKR THERAP
15MG/1.5ML (10MG/ML)
20MG/2ML (10MG/ML)
TABLET, EXTENDED RELEASE; ORAL
MORPHINE SULFATE
WATSON LABS
100MG

MOXALACTAM DISODIUM
INJECTABLE; INJECTION
MOXAM
LILLY

EQ
EQ
EQ
EQ
EQ

250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL

MYCOPHENOLATE MOFETIL
TABLET; ORAL
MYCOPHENOLATE MOFETIL
DR REDDYS LABS LTD

NABUMETONE
TABLET; ORAL
NABUMETONE
ACTAVIS ELIZABETH
COPLEY PHARM
SANDOZ

27,
27,
06,
25,
25,

2009
2009
2000
2002
2002

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6 - 236 (of 346)

NABUMETONE
TABLET; ORAL
RELAFEN
SMITHKLINE BEECHAM

500MG
750MG

N019583
N019583

001
002

120MG
160MG

N018063
N018063

003
004

120MG
160MG
80MG
120MG
160MG

A074255
A074255
A074368
A074368
A074368

002
003
001
002
003

EQ 250MG BASE

N050111

001

EQ 250MG BASE/5ML

N050199

001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
1.5GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL
10GM BASE/VIAL
500MG BASE/VIAL

A061984
A061984
A061984
A061984
A062844
A062844
A062844
A062844
A062844
A063008
A062527

001
002
003
005
001
002
003
004
005
001
001

EQ
EQ
EQ
EQ
EQ
EQ

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

A061999
A061999
A062755
A061999
A062755
A061999

001
002
001
003
002
004

EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
UNIPEN IN PLASTIC CONTAINER
WYETH AYERST
EQ 1GM BASE/VIAL
TABLET; ORAL
UNIPEN
WYETH AYERST
EQ 500MG BASE

A062717
N050320
A062717
A062717
N050320
N050320
N050320
N050320

001
001
002
004
003
004
005
006

N050320

002

N050462

001

Dec 24, 1991

Dec 24, 1991

NADOLOL
TABLET; ORAL
CORGARD
KING PHARMS
NADOLOL
IVAX SUB TEVA PHARMS
TEVA PHARMS

Jan
Jan
Aug
Aug
Aug

24,
24,
31,
31,
31,

1996
1996
1994
1994
1994

Oct
Oct
Oct
Oct
Oct
Sep
Aug

26,
26,
26,
26,
26,
29,
02,

1988
1988
1988
1988
1988
1988
1984

NAFCILLIN SODIUM
CAPSULE; ORAL
UNIPEN
WYETH AYERST
FOR SOLUTION; ORAL
UNIPEN
WYETH AYERST
INJECTABLE; INJECTION
NAFCILLIN SODIUM
APOTHECON

MARSAM PHARMS LLC

SANDOZ
NALLPEN
GLAXOSMITHKLINE

UNIPEN
WYETH AYERST

Dec 19, 1986

Dec 19, 1986

Dec 16, 1986

Dec 16, 1986
Dec 16, 1986

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6 - 237 (of 346)

NALBUPHINE HYDROCHLORIDE
INJECTABLE; INJECTION
NALBUPHINE
ABRAXIS PHARM

10MG/ML
20MG/ML

A070751
A070752

001
001

Jul 02, 1986

Sep 24, 1986

N020200
A070917
A072070
A072071
A072072
A072073
A072074
A072075
A074471
A074471

001
001
001
001
001
001
001
001
001
002

Mar
Feb
Apr
Apr
Apr
Apr
Apr
Apr
Mar
Mar

N018024
N018024

001
002

May 27, 1982

250MG/5ML

N017430

001

250MG
500MG
1GM
250MG
500MG
1GM

A070270
A070271
A070272
A071936
A072061
A071919

001
001
001
001
001
001

250MG
500MG
1GM

N014214
N014214
N014214

002
004
005

EQ 0.1MG BASE/ML
EQ 1MG BASE/ML

N020459
N020459

001
002

Apr 17, 1995

Apr 17, 1995

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

A070298
A070299
A070496
A070188
A070189
A070190
A070191

001
001
001
001
001
001
001

Sep
Sep
Sep
Sep
Sep
Sep
Sep

24,
24,
24,
24,
24,
24,
24,

1986
1986
1986
1986
1986
1986
1986

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

A070648
A070661
A070649
A071604
A072081
A072082
A072083
A072084
A072085

001
001
001
001
001
001
001
001
001

Nov
Nov
Nov
Dec
Apr
Apr
Apr
Apr
Apr

17,
17,
17,
16,
11,
11,
11,
11,
11,

1986
1986
1986
1988
1989
1989
1989
1989
1989

NALBUPHINE HYDROCHLORIDE
1.5MG/ML
ABBOTT
20MG/ML
10MG/ML
ASTRAZENECA
10MG/ML
10MG/ML
20MG/ML
20MG/ML
20MG/ML
BARR
10MG/ML
20MG/ML
NUBAIN
ENDO PHARMS
10MG/ML
20MG/ML

12,
03,
10,
10,
10,
10,
10,
10,
19,
19,

1993
1989
1989
1989
1989
1989
1989
1989
1998
1998

NALIDIXIC ACID
SUSPENSION; ORAL
NEGGRAM
SANOFI AVENTIS US
TABLET; ORAL
NALIDIXIC ACID
MUTUAL PHARM

WATSON LABS

NEGGRAM
SANOFI AVENTIS US

Jun
Jun
Jun
Jun
Jun
Jun

29,
29,
29,
29,
29,
29,

1988
1988
1988
1988
1988
1988

NALMEFENE HYDROCHLORIDE
INJECTABLE; INJECTION
REVEX
BAXTER HLTHCARE CORP

NALOXONE HYDROCHLORIDE
INJECTABLE; INJECTION
NALOXONE
BAXTER HLTHCARE

WYETH AYERST

NALOXONE HYDROCHLORIDE
ABRAXIS PHARM

ASTRAZENECA

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6 - 238 (of 346)

NALOXONE HYDROCHLORIDE
INJECTABLE; INJECTION
NALOXONE HYDROCHLORIDE
ASTRAZENECA

BAXTER HLTHCARE

HOSPIRA

INTL MEDICATION
MARSAM PHARMS LLC
SMITH AND NEPHEW

SOLOPAK
WATSON LABS
NARCAN
BRISTOL MYERS SQUIBB

ENDO PHARMS

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

A072086
A072087
A072088
A072089
A072090
A072091
A072092
A072093
A071272
A071273
A071274
A071287
A070171
A070252
A070253
A070255
A070417
A072115
A071811
A071671
A071681
A071682
A071672
A071683
A071339

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
May
May
May
May
Sep
Jan
Jan
Jan
Sep
Apr
Jul
Nov
Nov
Nov
Nov
Nov
Nov

11,
11,
11,
11,
11,
11,
11,
11,
24,
24,
24,
24,
24,
16,
16,
07,
24,
27,
19,
17,
17,
17,
17,
17,
18,

1989
1989
1989
1989
1989
1989
1989
1989
1988
1988
1988
1988
1986
1987
1987
1987
1986
1988
1988
1987
1987
1987
1987
1987
1987

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

A071083
A071084
A071311
N016636
N016636
N016636

001
001
001
002
001
003

Jul 28, 1988

Jul 28, 1988
Jul 28, 1988

EQ 0.5MG BASE;EQ 50MG BASE

N018733

001

Dec 16, 1982

50MG/ML
100MG/ML
200MG/ML

N013132
N013132
N013132

001
002
003

Jun 12, 1986

Jun 12, 1986
Jun 12, 1986

100MG/ML
200MG/ML
100MG/ML
50MG/ML
50MG/ML
50MG/ML
100MG/ML
100MG/ML
200MG/ML

A088290
A088317
A087519
A086385
A087598
A088554
A086598
A087599
A088128

001
001
001
001
001
001
001
001
001

Oct
Oct
Sep
Jan
Oct
Feb
Jan
Oct
Dec

25MG/ML
50MG/ML

N011891
N011891

001
002

Jun 14, 1982

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

TABLET; ORAL
TALWIN NX
SANOFI AVENTIS US

NANDROLONE DECANOATE
INJECTABLE; INJECTION
DECA-DURABOLIN
ORGANON USA INC

NANDROLONE DECANOATE
ABRAXIS PHARM
AKORN
WATSON LABS

NANDROLONE PHENPROPIONATE
INJECTABLE; INJECTION
DURABOLIN
ORGANON USA INC

03,
14,
28,
13,
06,
10,
13,
06,
05,

1983
1983
1983
1984
1983
1986
1984
1983
1983

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DISCONTINUED DRUG PRODUCT LIST

6 - 239 (of 346)

NANDROLONE PHENPROPIONATE
INJECTABLE; INJECTION
NANDROLONE PHENPROPIONATE
WATSON LABS
25MG/ML
50MG/ML

A086386
A087488

001
001

Jun 17, 1983

Jun 17, 1983

A040073
A088101

001
001

May 25, 1994

Apr 15, 1983

A080229

001

A087506

001

A080235

002

Mar 24, 1983

A074105
A074105
A074105
A074110
A074110
A074110
A074111
A074111
A074111
A074182
A074182
A074182
A074263
A074263
A074263
A074211
A074211
A074211
A074129
A074216
A074129
A074216
A074129
A074216
A074207
A074207
A074207
A074163
A074163
A074163

001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003
001
001
002
002
003
003
001
002
003
001
002
003

Dec
Dec
Dec
Oct
Oct
Oct
Feb
Feb
Feb
Jun
Jun
Jun
Dec
Dec
Dec
Feb
Feb
Feb
Dec
Apr
Dec
Apr
Dec
Apr
Dec
Dec
Dec
Feb
Feb
Feb

A074936
A074936

001
002

Feb 24, 1998

Feb 24, 1998

A076544
A076544
A074106
A074106

001
002
001
002

Aug
Aug
Aug
Aug

NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
NAFAZAIR
BAUSCH AND LOMB
0.1%
PHARMAFAIR
0.1%
NAPHCON FORTE
ALCON
0.1%
OPCON
BAUSCH AND LOMB
0.1%
VASOCON
NOVARTIS
0.1%

NAPROXEN
TABLET; ORAL
NAPROXEN
DAVA PHARMS INC

250MG
375MG
500MG
HAMILTON PHARMS
250MG
375MG
500MG
IVAX SUB TEVA PHARMS 250MG
375MG
500MG
PLIVA
250MG
375MG
500MG
PUREPAC PHARM
250MG
375MG
500MG
ROXANE
250MG
375MG
500MG
TEVA
250MG
250MG
375MG
375MG
500MG
500MG
TEVA PHARMS
250MG
375MG
500MG
WATSON LABS
250MG
375MG
500MG
TABLET, DELAYED RELEASE; ORAL
NAPROXEN
ACTAVIS ELIZABETH
375MG
500MG

21,
21,
21,
30,
30,
30,
28,
28,
28,
27,
27,
27,
21,
21,
21,
28,
28,
28,
21,
11,
21,
11,
21,
11,
21,
21,
21,
10,
10,
10,

1993
1993
1993
1992
1992
1992
1995
1995
1995
1996
1996
1996
1993
1993
1993
1994
1994
1994
1993
1996
1993
1996
1993
1996
1993
1993
1993
1995
1995
1995

NAPROXEN SODIUM
TABLET; ORAL
NAPROXEN SODIUM
ABLE
HAMILTON PHARMS

EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE

22,
22,
31,
31,

2003
2003
1993
1993

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DISCONTINUED DRUG PRODUCT LIST

6 - 240 (of 346)

NAPROXEN SODIUM
TABLET; ORAL
NAPROXEN SODIUM
IVAX SUB TEVA PHARMS

EQ 250MG
EQ 500MG
MYLAN
EQ 250MG
EQ 500MG
PLIVA
EQ 250MG
EQ 500MG
PUREPAC PHARM
EQ 250MG
EQ 500MG
ROXANE
EQ 250MG
EQ 500MG
SANDOZ
EQ 250MG
EQ 250MG
EQ 500MG
EQ 500MG
TEVA
EQ 250MG
EQ 500MG
TEVA PHARMS
EQ 250MG
EQ 500MG
WATSON LABS
EQ 250MG
EQ 500MG
TABLET, EXTENDED RELEASE; ORAL
NAPROXEN SODIUM
WATSON LABS FLORIDA
EQ 375MG
EQ 500MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A074230
A074230
A074367
A074367
A074242
A074242
A074319
A074319
A074257
A074257
A074162
A074495
A074162
A074495
A074142
A074142
A074289
A074289
A074195
A074195

001
002
001
002
001
002
001
002
001
002
001
001
002
002
001
002
001
002
001
002

Mar
Mar
Aug
Aug
Jun
Jun
Mar
Mar
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Jan
Jan
Dec
Dec

14,
14,
31,
31,
20,
20,
20,
20,
21,
21,
21,
05,
21,
05,
21,
21,
27,
27,
21,
21,

1995
1995
1994
1994
1996
1996
1995
1995
1993
1993
1993
1994
1993
1994
1993
1993
1994
1994
1993
1993

BASE
BASE

A075416
A075416

002
001

Apr 23, 2003

Aug 27, 2002

N019660

001

Dec 30, 1992

N020750

001

Oct 01, 1997

A075763
A075763
A075763
A075763
A075763
A076129
A076129
A076129
A076129
A076196
A076196
A076196
A076196
A076196
A076072
A076302
A076072
A076302
A076072
A076302
A076072
A076302
A076072
A076302

001
002
003
004
005
002
003
004
005
001
002
003
004
005
001
001
002
002
003
003
004
004
005
005

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

NEDOCROMIL SODIUM
AEROSOL, METERED; INHALATION
TILADE
KING PHARMS
1.75MG/INH
SOLUTION; INHALATION
TILADE
SANOFI AVENTIS US
0.5%

NEFAZODONE HYDROCHLORIDE
TABLET; ORAL
NEFAZODONE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 50MG
100MG
150MG
200MG
250MG
MYLAN
100MG
150MG
200MG
250MG
ROXANE
50MG
100MG
150MG
200MG
250MG
SANDOZ
50MG
50MG
100MG
100MG
150MG
150MG
200MG
200MG
250MG
250MG

16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,

2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003

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6 - 241 (of 346)

NEFAZODONE HYDROCHLORIDE
TABLET; ORAL
NEFAZODONE HYDROCHLORIDE
WATSON LABS
100MG
150MG
200MG
250MG
SERZONE
BRISTOL MYERS SQUIBB 50MG
100MG
150MG
200MG
250MG
300MG

A076073
A076073
A076073
A076073

002
003
004
005

Sep
Sep
Sep
Sep

16,
16,
16,
16,

2003
2003
2003
2003

N020152
N020152
N020152
N020152
N020152
N020152

001
002
003
004
005
006

Dec
Dec
Dec
Dec
Dec
Dec

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

1994
1994
1994
1994
1994
1994

EQ 87.5MG BASE/5ML

N050285

001

EQ 350MG BASE

A060520

001

EQ 350MG BASE

A060475

001

500MG
500MG
500MG
500MG
500MG

A060365
A060607
A060385
A062173
A061586

001
001
001
001
001

3.5MG BASE/GM;10,000 UNITS/GM

N050176

002

3.5MG BASE/GM;10,000 UNITS/GM

N050344

002

3.5MG BASE/ML;16,250 UNITS/ML

3.5MG BASE/ML;16,250 UNITS/ML

A062339
N050456

001
001

A061039
A061039

002
001

A061037

001

N050378

001

A062598

001

Jul 21, 1986

A062600

001

Jul 21, 1986

NEOMYCIN SULFATE
SOLUTION; ORAL
MYCIFRADIN
PHARMACIA AND UPJOHN
TABLET; ORAL
MYCIFRADIN
PHARMACIA AND UPJOHN
NEOBIOTIC
PFIZER
NEOMYCIN SULFATE
BRISTOL MYERS SQUIBB
LANNETT
LILLY
ROXANE
SANDOZ

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

CREAM; TOPICAL
NEOSPORIN
GLAXOSMITHKLINE
EQ
OINTMENT; OPHTHALMIC
STATROL
ALCON
EQ
SOLUTION/DROPS; OPHTHALMIC
STATROL
ALCON
EQ
EQ

Jan 14, 1985

Nov 30, 1984

NEOMYCIN SULFATE; PREDNISOLONE ACETATE

OINTMENT; OPHTHALMIC
NEO-DELTA-CORTEF
PHARMACIA AND UPJOHN

EQ 3.5MG BASE/GM;0.25%
EQ 3.5MG BASE/GM;0.5%
SUSPENSION/DROPS; OPHTHALMIC
NEO-DELTA-CORTEF
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%

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6 - 242 (of 346)

NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE

CREAM; TOPICAL
NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE
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%

A062595

001

Jul 21, 1986

A062609

001

May 23, 1986

A062608
A062607

001
001

May 23, 1986

May 23, 1986

EQ 10MG BASE/ML
EQ 25MG BASE/ML
EQ 100MG BASE/ML

N050544
N050544
N050544

001
002
003

Feb 28, 1983

Feb 28, 1983
Feb 28, 1983

500MG

N011073

003

500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG

A083203
A083453
A083115
A083180
A083525
A083271
A083306
A084237
A083136
A083305
A085172
A083718

001
001
001
001
001
001
001
001
001
001
001
001

A083823

001

A076378
A076378
A076250

001
002
001

Apr 26, 2005

Apr 26, 2005
Apr 14, 2005

N020381

001

Jul 28, 1997

N020381

005

Jul 28, 1997

N008378

003

N020005

002

Feb 21, 1992

N018669

001

May 14, 1982

NETILMICIN SULFATE
INJECTABLE; INJECTION
NETROMYCIN
SCHERING

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
TABLET, EXTENDED RELEASE; ORAL
NIACIN
BARR
500MG
750MG
1GM
NIASPAN
ABBOTT
375MG
NIASPAN TITRATION STARTER PACK
ABBOTT
375MG;500MG;750MG

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

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6 - 243 (of 346)

NICOTINE
FILM, EXTENDED RELEASE; TRANSDERMAL
NICOTROL
MCNEIL CONS
15MG/16HR
PROSTEP
AVEVA
11MG/24HR
22MG/24HR

N020536

001

Jul 03, 1996

N019983
N019983

003
004

Dec 23, 1998

Dec 23, 1998

EQ 2MG BASE
EQ 4MG BASE

A076568
A076569

001
002

Jul 29, 2004

Jul 29, 2004

10MG
20MG

N019478
N019478

001
002

Nov 27, 1985

Sep 17, 1986

20MG
10MG
20MG
10MG

A074045
A072409
A073421
A072651

001
001
001
001

Apr
Jul
Jun
Feb

20MG
ORAL

N018482

002

Jul 24, 1986

90MG
30MG

A075414
A075108

003
001

Mar 23, 2004

Dec 17, 1999

50MG

N020169

001

Sep 19, 1996

30MG

N018869

001

Dec 28, 1988

TABLET, EXTENDED RELEASE; ORAL

SULAR
SHIONOGI INC
10MG
20MG
30MG
40MG

N020356
N020356
N020356
N020356

001
002
003
004

Feb
Feb
Feb
Feb

50MG
100MG

A084326
A084326

001
002

50MG
100MG

N008693
N008693

001
002

50MG
100MG

A080017
A080017

001
002

50MG

A080003

001

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;
NIFEDIPINE
MARTEC USA LLC
MYLAN

30,
04,
19,
19,

1992
1990
1991
1992

NILUTAMIDE
TABLET; ORAL
NILANDRON
SANOFI AVENTIS US

NIMODIPINE
CAPSULE; ORAL
NIMOTOP
BAYER PHARMS

NISOLDIPINE

NITROFURANTOIN
CAPSULE; ORAL
NITROFURANTOIN
WATSON LABS
TABLET; ORAL
FURADANTIN
PROCTER AND GAMBLE
FURALAN
LANNETT
NITROFURANTOIN
ELKINS SINN

02,
02,
02,
02,

1995
1995
1995
1995

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6 - 244 (of 346)

NITROFURANTOIN
TABLET; ORAL
NITROFURANTOIN
ELKINS SINN
IVAX SUB TEVA PHARMS
SANDOZ
WATSON LABS

WHITEWORTH TOWN PLSN

100MG
50MG
100MG
50MG
100MG
50MG
50MG
100MG
100MG
100MG

A080003
A080078
A080078
A080043
A080043
A080447
A085797
A080447
A085796
A084085

002
002
001
001
002
001
001
002
001
002

EQ 180MG BASE/VIAL

N012402

001

A074967
A074336
A074336
A074336

002
001
002
003

Jul
Jan
Jan
Jan

A070248
A070249

001
001

Jun 24, 1988

Jun 24, 1988

0.2%

A083789

001

0.2%

N017343

001

0.2%

N005795

001

0.2%
0.2%
0.2%
0.2%
0.2%

A086077
A084393
A084968
A086156
A086766

001
001
001
001
001

0.2%

A083791

001

0.2%
0.2%

A085130
A087081

001
001

N018705

001

Oct 31, 1985

A074992
A074992
A074992
A074992

004
003
002
001

Nov
Nov
Nov
Nov

NITROFURANTOIN SODIUM
INJECTABLE; INJECTION
IVADANTIN
PROCTER AND GAMBLE

NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE; ORAL
NITROFURANTOIN
MYLAN
SANDOZ

100MG
25MG
50MG
100MG
NITROFURANTOIN MACROCRYSTALLINE
WATSON LABS
50MG
100MG

09,
25,
25,
25,

1997
1995
1995
1995

NITROFURAZONE
CREAM; TOPICAL
FURACIN
SHIRE
DRESSING; TOPICAL
ACTIN-N
SHERWOOD MEDCL
OINTMENT; TOPICAL
FURACIN
SHIRE
NITROFURAZONE
AMBIX
LANNETT
PERRIGO NEW YORK
TARO
WENDT
POWDER; TOPICAL
FURACIN
SHIRE
SOLUTION; TOPICAL
NITROFURAZONE
PERRIGO NEW YORK
WENDT

NITROGLYCERIN
AEROSOL; SUBLINGUAL

NITROLINGUAL

POHL BOSKAMP
0.4MG/SPRAY
FILM, EXTENDED RELEASE; TRANSDERMAL
NITROGLYCERIN
MYLAN TECHNOLOGIES
0.1MG/HR
0.2MG/HR
0.4MG/HR
0.6MG/HR

12,
12,
12,
12,

1999
1999
1999
1999

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6 - 245 (of 346)

NITROGLYCERIN
FILM, EXTENDED RELEASE; TRANSDERMAL
TRANSDERM-NITRO
NOVARTIS
0.1MG/HR
0.2MG/HR
0.4MG/HR
0.6MG/HR
0.8MG/HR
INJECTABLE; INJECTION
NITRO IV
POHL BOSKAMP
5MG/ML
NITRO-BID
SANOFI AVENTIS US
5MG/ML
10MG/ML
NITROGLYCERIN
ABRAXIS PHARM
5MG/ML
5MG/ML
INTL MEDICATION
5MG/ML
LUITPOLD
5MG/ML
SMITH AND NEPHEW
5MG/ML
5MG/ML
NITROGLYCERIN IN DEXTROSE 5%
HOSPIRA
0.1MG/ML
NITROL
RORER
0.8MG/ML
NITRONAL
POHL BOSKAMP
1MG/ML
NITROSTAT
PARKE DAVIS
0.8MG/ML
5MG/ML
5MG/ML
10MG/ML
10MG/ML
TRIDIL
HOSPIRA
0.5MG/ML
5MG/ML

N020144
N020144
N020144
N020144
N020144

001
002
003
004
005

Feb
Feb
Feb
Feb
Feb

27,
27,
27,
27,
27,

N018672

002

Aug 30, 1983

N018621
A071159

001
001

Jan 05, 1982

Feb 28, 1990

A070077
A071203
A070026
A071492
A070633
A070634

001
001
001
001
001
001

Dec
May
Sep
May
Jun
Jun

A074083

001

Oct 26, 1994

N018774

001

Jan 19, 1983

N018672

001

Aug 30, 1983

N018588
A070863
N018588
A070871
A070872

001
001
002
001
001

Jan
Dec
Jan
Jan

N018537
N018537

002
001

Jun 16, 1983

150MG
300MG

A075461
A075461

001
002

Jul 08, 2002

Jul 08, 2002

12.5%

N014349

002

A040522

001

13,
08,
10,
24,
19,
19,

08,
23,
08,
08,

1996
1996
1996
1996
1996

1985
1987
1985
1988
1986
1986

1987
1983
1987
1987

NIZATIDINE
CAPSULE; ORAL
NIZATIDINE
IVAX SUB TEVA PHARMS

NONOXYNOL-9
AEROSOL; VAGINAL
DELFEN
PERSONAL PRODS

NOREPINEPHRINE BITARTRATE
INJECTABLE; INJECTION
NOREPINEPHRINE BITARTRATE
METRICS PHARM
EQ 1MG BASE/ML

Sep 30, 2004

NOREPINEPHRINE BITARTRATE; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE

INJECTABLE; INJECTION
RAVOCAINE AND NOVOCAIN W/ LEVOPHED
EASTMAN KODAK
EQ 0.033MG BASE/ML;2%;0.4%

N008592

003

N010895

002

NORETHINDRONE
TABLET; ORAL
NORLUTIN
PARKE DAVIS

5MG

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6 - 246 (of 346)

NORETHINDRONE ACETATE
TABLET; ORAL
NORLUTATE
PARKE DAVIS

5MG

N012184

002

N019757

001

N017031

001

BASE
BASE

N014684
N014684

001
002

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A074054
A074835
A074054
A074835
A074054
A074835
A074054
A074835
A073667
A073667
A073667
A073667

001
001
002
002
003
003
004
004
001
002
003
004

BASE/5ML

N018012

001

100,000 UNITS/GM

A061810

001

100,000 UNITS/GM

A060575

001

100,000 UNITS/GM

A062387

001

100,000 UNITS/GM

A061445

001

100,000 UNITS/GM
100,000 UNITS/GM

A062457
A061966

001
001

100,000 UNITS/ML

N050233

001

100,000 UNITS/GM

A060571

001

100,000 UNITS/GM

A062731

001

100,000 UNITS/GM

A061444

001

200,000 UNITS

N050619

001

NORFLOXACIN
SOLUTION/DROPS; OPHTHALMIC
CHIBROXIN
MERCK
0.3%

Jun 17, 1991

NORGESTREL
TABLET; ORAL
OVRETTE
WYETH PHARMS

0.075MG

NORTRIPTYLINE HYDROCHLORIDE
CAPSULE; ORAL
AVENTYL HYDROCHLORIDE
LILLY

EQ 10MG
EQ 25MG
NORTRIPTYLINE HYDROCHLORIDE
SANDOZ
EQ 10MG
EQ 10MG
EQ 25MG
EQ 25MG
EQ 50MG
EQ 50MG
EQ 75MG
EQ 75MG
TEVA
EQ 10MG
EQ 25MG
EQ 50MG
EQ 75MG
SOLUTION; ORAL
PAMELOR
MALLINCKRODT INC
EQ 10MG

Dec
Jun
Dec
Jun
Dec
Jun
Dec
Jun
Apr
Apr
Apr
Apr

31,
30,
31,
30,
31,
30,
31,
30,
11,
11,
11,
11,

1992
1997
1992
1997
1992
1997
1992
1997
1996
1996
1996
1996

NYSTATIN
CREAM; TOPICAL
CANDEX
BAYER PHARMS
MYCOSTATIN
BRISTOL MYERS SQUIBB
MYKINAC
ALPHARMA US PHARMS
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

Jul 29, 1982

Jul 28, 1983

Sep 22, 1986

Apr 09, 1987

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6 - 247 (of 346)

NYSTATIN
POWDER; ORAL
BARSTATIN 100
BARLAN
NILSTAT
DAVA PHARMS INC
NYSTATIN
PADDOCK LLC
POWDER; TOPICAL
MYCOSTATIN
BRISTOL MYERS SQUIBB
SUPPOSITORY; VAGINAL
NYSERT
WARNER CHILCOTT
SUSPENSION; ORAL
MYCOSTATIN
APOTHECON
NYSTATIN
ALPHARMA US PHARMS
MORTON GROVE
PHARMADERM
PHARMAFAIR
ROXANE
TEVA
NYSTEX
SAVAGE LABS
TABLET; ORAL
MYCOSTATIN
BRISTOL MYERS SQUIBB
NILSTAT
LEDERLE
NYSTATIN
HERITAGE PHARMS INC
QUANTUM PHARMICS
SANDOZ
USL PHARMA
WATSON LABS
TABLET; VAGINAL
KOROSTATIN
HOLLAND RANTOS
MYCOSTATIN
BRISTOL MYERS SQUIBB
NILSTAT
LEDERLE
NYSTATIN
FOUGERA
PHARMADERM
QUANTUM PHARMICS
SANDOZ
TEVA
WATSON LABS

100%

A062489

001

Apr 27, 1988

100%

N050576

001

Dec 22, 1983

100%

A062613

001

Nov 26, 1985

100,000 UNITS/GM

A060578

001

100,000 UNITS

N050478

001

100,000 UNITS/ML

A061533

001

100,000
100,000
100,000
100,000
100,000
100,000
100,000

UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML
UNITS/ML

A062571
A062835
A062518
A062541
A062832
A062670
A062776

001
001
001
001
001
001
001

Oct
Nov
Jul
Jan
Dec
Jun
Dec

100,000 UNITS/ML

A062519

001

Jul 06, 1984

500,000 UNITS

A060574

001

500,000 UNITS

A061151

001

500,000
500,000
500,000
500,000
500,000

UNITS
UNITS
UNITS
UNITS
UNITS

A062474
A062525
A062065
A062524
A062402

001
001
001
001
001

100,000 UNITS

A061718

001

100,000 UNITS

A060577

001

100,000 UNITS

A061325

001

100,000
100,000
100,000
100,000
100,000
100,000

A062459
A062460
A062509
A061965
A062502
A062176

001
001
001
001
001
001

Nov 09, 1983

Nov 09, 1983
Apr 03, 1984

100,000 UNITS/GM;0.1%
100,000 UNITS/GM;0.1%

A060576
A062606

002
001

May 01, 1985

May 15, 1985

100,000 UNITS/GM;0.1%

A061954

002

Sep 20, 1985

100,000 UNITS/GM;0.1%

A062367

001

May 28, 1985

100,000 UNITS/GM;0.1%

A062597

001

Oct 08, 1985

UNITS
UNITS
UNITS
UNITS
UNITS
UNITS

29,
19,
06,
16,
27,
18,
17,

1985
1987
1984
1985
1991
1987
1987

Dec 22, 1983

Oct 29, 1984
Nov 26, 1985
Dec 16, 1982

Dec 23, 1983

NYSTATIN; TRIAMCINOLONE ACETONIDE

CREAM; TOPICAL
MYCOLOG-II
APOTHECON
MYCO-TRIACET II
TEVA
MYKACET
ACTAVIS MID ATLANTIC
MYTREX F
SAVAGE LABS

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6 - 248 (of 346)

NYSTATIN; TRIAMCINOLONE ACETONIDE

CREAM; TOPICAL
NYSTATIN AND TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS
100,000 UNITS/GM;0.1%
PERRIGO NEW YORK
100,000 UNITS/GM;0.1%
PHARMAFAIR
100,000 UNITS/GM;0.1%
TARO
100,000 UNITS/GM;0.1%
NYSTATIN-TRIAMCINOLONE ACETONIDE
PHARMADERM
100,000 UNITS/GM;0.1%
OINTMENT; TOPICAL
MYCOLOG-II
APOTHECON
100,000 UNITS/GM;0.1%
MYCO-TRIACET II
TEVA
100,000 UNITS/GM;0.1%
MYKACET
ACTAVIS MID ATLANTIC 100,000 UNITS/GM;0.1%
MYTREX F
SAVAGE LABS
100,000 UNITS/GM;0.1%
NYSTATIN AND TRIAMCINOLONE ACETONIDE
PERRIGO NEW YORK
100,000 UNITS/GM;0.1%
PHARMAFAIR
100,000 UNITS/GM;0.1%
NYSTATIN-TRIAMCINOLONE ACETONIDE
PHARMADERM
100,000 UNITS/GM;0.1%

A063010
A062186
A062657
A062347

001
002
001
001

Dec
Jun
Jul
Mar

20,
06,
30,
30,

1988
1985
1986
1987

A062596

001

Oct 08, 1985

A060572

001

Jun 28, 1985

A062045

002

Nov 26, 1985

A062733

001

Mar 09, 1987

A062601

001

Oct 09, 1985

A062280
A062656

002
001

Oct 10, 1985

Jul 30, 1986

A062603

001

Oct 09, 1985

N020087
N020087

002
003

Mar 31, 1992

Mar 31, 1992

N020087

001

Mar 31, 1992

N020087
N020087

004
005

Mar 31, 1992

Mar 31, 1992

A075762

001

Jan 16, 2002

N019735
N019735
N019735

001
002
003

Dec 28, 1990

Dec 28, 1990
Dec 28, 1990

A076093
A076093
A076093

001
002
003

Sep 02, 2003

Sep 02, 2003
Sep 02, 2003

A076695

001

Dec 26, 2006

A076978

001

Feb 26, 2007

A076696

001

Dec 26, 2006

N020403

001

Jan 31, 1995

N012157

001

A088067

001

OFLOXACIN
INJECTABLE; INJECTION
FLOXIN
ORTHO MCNEIL PHARM

20MG/ML
40MG/ML

FLOXIN IN DEXTROSE 5%
ORTHO MCNEIL PHARM
400MG/100ML
FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ORTHO MCNEIL PHARM
4MG/ML
400MG/100ML
OFLOXACIN
BEDFORD
40MG/ML
TABLET; ORAL
FLOXIN
JANSSEN PHARMS
200MG
300MG
400MG
OFLOXACIN
LARKEN LABS
200MG
300MG
400MG

ONDANSETRON HYDROCHLORIDE
INJECTABLE; INJECTION
ONDANSETRON HYDROCHLORIDE
HOSPIRA
EQ 2MG BASE/ML
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
HOSPIRA
EQ 0.64MG BASE/ML
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
HOSPIRA
EQ 2MG BASE/ML
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
GLAXOSMITHKLINE
EQ 0.64MG BASE/ML

ORPHENADRINE CITRATE
TABLET, EXTENDED RELEASE; ORAL
NORFLEX
MEDICIS
100MG
ORPHENADRINE CITRATE
ASCOT
100MG

Apr 06, 1983

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6 - 249 (of 346)

ORPHENADRINE CITRATE
TABLET, EXTENDED RELEASE; ORAL
ORPHENADRINE CITRATE
SANDOZ
100MG
WATSON LABS
100MG

A085046
A084303

001
001

50MG

N010653

001

EQ 12MG BASE/ML

N021246

001

EQ
EQ
EQ
EQ

250MG
250MG
500MG
500MG

BASE
BASE
BASE
BASE

A061336
A062241
A061336
A062241

001
001
002
002

EQ
EQ
EQ
EQ

250MG
500MG
250MG
500MG

BASE
BASE
BASE
BASE

A061450
A061450
A062222
A062222

002
001
001
002

EQ 500MG BASE

N050118

002

EQ 250MG BASE/5ML

A062321

001

EQ 250MG BASE/5ML
EQ 250MG BASE/5ML

A061457
A062252

001
001

EQ 250MG BASE/5ML

N050194

001

EQ
EQ
EQ
EQ
EQ
EQ
EQ

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

A061334
A061334
A062736
A061334
A062736
A061334
A061334

009
006
001
007
002
008
010

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL
10GM BASE/VIAL
125MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL

N050195
N050195
N050195
N050195
N050195
A062711
A062711
A062711
A062711
A062711
A062711
A062798
A062798
A062798
A062798

001
002
003
004
005
001
002
003
004
005
006
003
004
005
001

ORPHENADRINE HYDROCHLORIDE
TABLET; ORAL
DISIPAL
3M

OSELTAMIVIR PHOSPHATE
FOR SUSPENSION; ORAL
TAMIFLU
ROCHE

Dec 14, 2000

OXACILLIN SODIUM
CAPSULE; ORAL
BACTOCILL
GLAXOSMITHKLINE

OXACILLIN SODIUM
APOTHECON
TEVA
PROSTAPHLIN
APOTHECON
FOR SOLUTION; ORAL
BACTOCILL
GLAXOSMITHKLINE
OXACILLIN SODIUM
APOTHECON
TEVA
PROSTAPHLIN
APOTHECON
INJECTABLE; INJECTION
BACTOCILL
GLAXOSMITHKLINE

OXACILLIN SODIUM
APOTHECON

ELKINS SINN

IBI

Mar
Mar
Dec
Mar
Dec
Mar

26,
26,
19,
26,
19,
26,

1982
1982
1986
1982
1986
1982

Feb
Feb
Feb
Feb
Feb
Feb
Dec
Dec
Dec
Dec

03,
03,
03,
03,
03,
03,
11,
11,
11,
11,

1989
1989
1989
1989
1989
1989
1995
1995
1995
1995

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6 - 250 (of 346)

OXACILLIN SODIUM
INJECTABLE; INJECTION

OXACILLIN SODIUM

IBI
MARSAM PHARMS LLC
SANDOZ
WATSON LABS

A062798
A062984
A061490
A061490
A062856
A062856
A062856
A062856
A062856

002
001
001
002
001
002
003
004
005

Dec 11, 1995

Sep 29, 1988

N021492
N021492

001
002

Aug 09, 2002

Aug 09, 2002

250MG

N018069

001

2.5MG
10MG

A077249
A077249

001
002

Jul 10, 2007

Jul 10, 2007

600MG
600MG
600MG
600MG

A075843
A075851
A075842
A075850

001
001
001
001

Oct
Aug
Apr
Apr

600MG

N020776

001

Oct 17, 2002

10MG
15MG
30MG
10MG
15MG
30MG
10MG
15MG
30MG

A071955
A071956
A071957
A071026
A071026
A071026
A071713
A071714
A071715

001
001
001
002
003
001
001
001
001

Mar
Mar
Mar
Aug
Aug
Aug
Oct
Oct
Oct

10MG
15MG
30MG

N015539
N015539
N015539

002
004
006

10MG
15MG
30MG

A070650
A070640
A070641

001
001
001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

2GM BASE/VIAL
10GM BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
4GM BASE/VIAL

Oct
Oct
Oct
Oct
Oct

26,
26,
26,
26,
26,

1988
1988
1988
1988
1988

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

OXAMNIQUINE
CAPSULE; ORAL
VANSIL
PFIZER

OXANDROLONE
TABLET; ORAL
OXANDROLONE
ROXANE

OXAPROZIN
TABLET; ORAL
OXAPROZIN
ACTAVIS ELIZABETH
MYLAN
SANDOZ

03,
17,
12,
27,

2001
2001
2001
2001

OXAPROZIN POTASSIUM
TABLET; ORAL
DAYPRO ALTA
GD SEARLE

OXAZEPAM
CAPSULE; ORAL
OXAZEPAM
AM THERAP

MUTUAL PHARM

MYLAN

SERAX
ALPHARMA US PHARMS

ZAXOPAM
QUANTUM PHARMICS

03,
03,
03,
10,
10,
10,
20,
20,
20,

1988
1988
1988
1987
1987
1987
1987
1987
1987

Mar 01, 1988

Mar 01, 1988
Mar 01, 1988

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6 - 251 (of 346)

OXAZEPAM
TABLET; ORAL
OXAZEPAM
MUTUAL PHARM
PARKE DAVIS
WATSON LABS
SERAX
ALPHARMA US PHARMS

15MG
15MG
15MG

A070683
A071508
A071494

001
001
001

Jan 16, 1987

Feb 02, 1987
Apr 21, 1987

15MG

N015539

008

20MG
40MG
80MG
160MG

N018166
N018166
N018166
N018166

001
002
003
004

Dec
Dec
Dec
Dec

N009268

012

Nov 27, 1984

A088243

001

Dec 05, 1983

N009268

011

A088242

001

N009268
N009268

003
007

A087866
A087835

001
001

5MG/5ML

N018211

001

5MG
5MG
5MG

A072296
A070746
A072485

001
001
001

Dec 08, 1988

Mar 10, 1988
Apr 19, 1989

N020553
N020553
N020553
N020553
N020553
N020553
N020553
N020553

001
006
002
007
003
008
004
005

Dec
Sep
Dec
Sep
Dec
Sep
Jan
Mar

N020932
N020932

001
002

Oct 26, 1998

Oct 26, 1998

OXPRENOLOL HYDROCHLORIDE
CAPSULE; ORAL
TRASICOR
NOVARTIS

28,
28,
28,
28,

1983
1983
1983
1983

OXTRIPHYLLINE
SOLUTION; ORAL
CHOLEDYL
PARKE DAVIS
100MG/5ML
OXTRIPHYLLINE
MORTON GROVE
100MG/5ML
SYRUP; ORAL
CHOLEDYL
PARKE DAVIS
50MG/5ML
OXTRIPHYLLINE PEDIATRIC
MORTON GROVE
50MG/5ML
TABLET, DELAYED RELEASE; ORAL
CHOLEDYL
PARKE DAVIS
100MG
200MG
OXTRIPHYLLINE
WATSON LABS
100MG
200MG

Dec 05, 1983

Aug 25, 1983

Aug 25, 1983

OXYBUTYNIN CHLORIDE
SYRUP; ORAL
DITROPAN
ORTHO MCNEIL JANSSEN
TABLET; ORAL
OXYBUTYNIN CHLORIDE
QUANTUM PHARMICS
USL PHARMA
WATSON LABS

OXYCODONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
OXYCONTIN
PURDUE PHARMA LP
10MG
15MG
20MG
30MG
40MG
60MG
80MG
160MG
ROXICODONE
ROXANE
10MG
30MG

12,
18,
12,
18,
12,
18,
06,
15,

1995
2006
1995
2006
1995
2006
1997
2000

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6 - 252 (of 346)

OXYMORPHONE HYDROCHLORIDE
INJECTABLE; INJECTION
OPANA
ENDO PHARMS
SUPPOSITORY; RECTAL
NUMORPHAN
ENDO PHARMS
TABLET, EXTENDED RELEASE;
OPANA ER
ENDO PHARMS

1.5MG/ML

N011707

001

5MG
ORAL

N011738

004

7.5MG
15MG

N021610
N021610

005
006

Feb 29, 2008

Feb 29, 2008

100MG

A088399

001

Sep 17, 1984

100MG

N012542

004

Sep 03, 1982

10MG

N011612

001

5MG

N008492

002

250MG

N050287

001

EQ 125MG BASE/5ML

A060595

001

BASE

A060179

001

BASE
BASE
BASE
BASE

A060760
A060869
A060634
A060770

001
001
001
001

BASE
BASE

N050286
N050286

001
002

BASE/VIAL
BASE/VIAL

A060586
A060586

001
002

A061841

001

A061009

001

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
EQ 250MG
OXYTETRACYCLINE HYDROCHLORIDE
IMPAX LABS
EQ 250MG
PROTER
EQ 250MG
PUREPAC PHARM
EQ 250MG
WEST WARD
EQ 250MG
TERRAMYCIN
PFIZER
EQ 125MG
EQ 250MG
INJECTABLE; INJECTION
TERRAMYCIN
PFIZER
EQ 250MG
EQ 500MG

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

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OXYTOCIN
INJECTABLE; INJECTION
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
1USP UNITS/100ML
SYNTOCINON
NOVARTIS
10USP UNITS/ML
SOLUTION; NASAL
SYNTOCINON
NOVARTIS
40USP UNITS/ML

N019185
N019185

004
003

Mar 29, 1985

Mar 29, 1985

N019185

002

Mar 29, 1985

N019185

001

Mar 29, 1985

N018245

001

N012285

001

6MG/ML
6MG/ML
6MG/ML

A076233
A077413
A075297

001
001
001

Aug 01, 2002

Mar 12, 2008
Jan 25, 2002

6MG/ML

N020262

001

Dec 29, 1992

N021999

004

Dec 19, 2006

EQ 0.5MG BASE

N022233

001

Aug 22, 2008

60MG/VIAL
90MG/VIAL

N020036
N020036

003
004

May 06, 1993

May 06, 1993

30MG/VIAL
90MG/VIAL

A075594
A075594

001
002

May 06, 2002

May 06, 2002

30,000USP UNITS;8,000USP
UNITS;30,000USP UNITS

N020580

001

Dec 09, 1996

1MG/ML
2MG/ML
2MG/ML
2MG/ML
1MG/ML
2MG/ML
2MG/ML
2MG/ML

A072210
A072211
A072212
A072213
A072058
A072059
A072060
A072321

001
001
001
001
001
001
001
001

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Jan

1MG/ML
2MG/ML

N017015
N017015

002
001

PACLITAXEL
INJECTABLE; INJECTION
PACLITAXEL
HOSPIRA
PLIVA LACHEMA
TEVA PARENTERAL
TAXOL
BRISTOL MYERS SQUIBB

PALIPERIDONE
TABLET, EXTENDED RELEASE; ORAL
INVEGA
JANSSEN PHARMS
12MG

PALONOSETRON HYDROCHLORIDE
CAPSULE; ORAL
ALOXI
HELSINN HLTHCARE

PAMIDRONATE DISODIUM
INJECTABLE; INJECTION
AREDIA
NOVARTIS
PAMIDRONATE DISODIUM
AESGEN

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE; ORAL
COTAZYM
ORGANON USA INC

PANCURONIUM BROMIDE
INJECTABLE; INJECTION

PANCURONIUM BROMIDE

ASTRAZENECA

ELKINS SINN

HOSPIRA
PAVULON
ORGANON USA INC

31,
31,
31,
31,
23,
23,
23,
19,

1988
1988
1988
1988
1988
1988
1988
1989

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6 - 254 (of 346)

PARAMETHADIONE
CAPSULE; ORAL
PARADIONE
ABBOTT

150MG
300MG

N006800
N006800

003
001

300MG/ML

N006800

002

1MG
2MG

N012772
N012772

005
006

10MG
25MG
50MG

N013448
N013448
N013448

002
003
004

EQ 250MG BASE
EQ 250MG BASE

A062310
A060521

001
001

EQ 125MG BASE/5ML

A060522

001

EQ
EQ
EQ
EQ

10MG
20MG
30MG
40MG

BASE
BASE
BASE
BASE

N020885
N020885
N020885
N020885

001
002
003
004

Oct
Oct
Oct
Oct

09,
09,
09,
09,

1998
1998
1998
1998

TABLET; ORAL
PAROXETINE HYDROCHLORIDE
ACTAVIS ELIZABETH
EQ
EQ
EQ
EQ
ROXANE
EQ
EQ
EQ
EQ
SANDOZ
EQ
EQ
EQ
EQ
EQ
TEVA PHARMS
EQ
EQ
EQ
PAXIL
GLAXOSMITHKLINE
EQ

10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A076968
A076968
A076968
A076968
A078026
A078026
A078026
A078026
A075566
A075566
A075566
A075566
A077082
A077082
A077082
A077082

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Jun
Jun
Jun
Jun

21,
21,
21,
21,
29,
29,
29,
29,
08,
08,
08,
08,
29,
29,
29,
29,

2010
2010
2010
2010
2007
2007
2007
2007
2004
2004
2004
2004
2007
2007
2007
2007

50MG BASE

N020031

004

Dec 29, 1992

N016832

001

SOLUTION; ORAL
PARADIONE
ABBOTT

PARAMETHASONE ACETATE
TABLET; ORAL
HALDRONE
LILLY

PARGYLINE HYDROCHLORIDE
TABLET; ORAL
EUTONYL
ABBOTT

PAROMOMYCIN SULFATE
CAPSULE; ORAL
HUMATIN
KING PFIZER
PARKEDALE
SYRUP; ORAL
HUMATIN
PARKE DAVIS

PAROXETINE HYDROCHLORIDE
CAPSULE; ORAL
PAXIL
GLAXOSMITHKLINE

PEMOLINE
TABLET; ORAL
CYLERT
ABBOTT

18.75MG

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DISCONTINUED DRUG PRODUCT LIST

6 - 255 (of 346)

PEMOLINE
TABLET; ORAL
CYLERT
ABBOTT
PEMOLINE
ACTAVIS TOTOWA

MALLINCKRODT

SANDOZ

TEVA PHARMS

VINTAGE PHARMS

WATSON LABS

TABLET, CHEWABLE; ORAL

CYLERT
ABBOTT
PEMOLINE
ACTAVIS TOTOWA
TEVA PHARMS

37.5MG
75MG

N016832
N016832

002
003

18.75MG
37.5MG
75MG
18.75MG
37.5MG
75MG
18.75MG
37.5MG
75MG
18.75MG
37.5MG
75MG
18.75MG
37.5MG
75MG
18.75MG
37.5MG
75MG

A075595
A075595
A075595
A075726
A075726
A075726
A075286
A075286
A075286
A075030
A075030
A075030
A075328
A075328
A075328
A075287
A075287
A075287

001
002
003
003
002
001
001
002
003
003
001
002
001
002
003
001
002
003

37.5MG

N017703

001

37.5MG
37.5MG

A075678
A075555

001
001

Jul 26, 2000

Feb 18, 2000

10MG

N018976

001

Dec 30, 1987

125MG

N019853

002

300,000 UNITS/ML

N050131

001

300,000 UNITS/5ML

N050126

002

200,000 UNITS

N050128

001

200,000 UNITS/5ML
400,000 UNITS/5ML

A060307
A060307

002
004

200,000
250,000
400,000
250,000
400,000

A060752
A060752
A060752
A061740
A061740

003
002
001
001
002

Feb
Feb
Feb
Mar
Mar
Mar
Dec
Jun
Jun
Feb
Jan
Jan
Apr
Apr
Apr
Jun
Sep
Sep

28,
28,
28,
30,
30,
30,
27,
30,
30,
22,
29,
29,
19,
19,
19,
13,
18,
18,

2000
2000
2000
2001
2001
2001
1999
1999
1999
2000
1999
1999
2000
2000
2000
2001
2000
2000

PENBUTOLOL SULFATE
TABLET; ORAL
LEVATOL
SCHWARZ PHARMA

PENICILLAMINE
CAPSULE; ORAL
CUPRIMINE
ATON

PENICILLIN G BENZATHINE
INJECTABLE; INJECTION
BICILLIN L-A
WYETH AYERST
SUSPENSION; ORAL
BICILLIN
WYETH AYERST
TABLET; ORAL
BICILLIN
WYETH AYERST

PENICILLIN G POTASSIUM
FOR SOLUTION; ORAL
PENICILLIN
TEVA
PENICILLIN G POTASSIUM
MYLAN

PUREPAC PHARM

UNITS/5ML
UNITS/5ML
UNITS/5ML
UNITS/5ML
UNITS/5ML

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 256 (of 346)

PENICILLIN G POTASSIUM
FOR SOLUTION; ORAL
PENICILLIN-2
TEVA
PENTIDS '200'
APOTHECON
PENTIDS '400'
APOTHECON
PFIZERPEN G
PFIZER
INJECTABLE; INJECTION
PENICILLIN G POTASSIUM
APOTHECON

CONSOLIDATED PHARM

LILLY

MARSAM PHARMS LLC

PARKE DAVIS
PFIZER
SANDOZ

PFIZERPEN

PFIZER

TABLET; ORAL
PENICILLIN G POTASSIUM
APOTHECON
IVAX SUB TEVA PHARMS
LILLY
MYLAN

PUREPAC PHARM

TEVA

WYETH AYERST

PENTIDS '200'

APOTHECON

PENTIDS '250'

APOTHECON

PENTIDS '400'

APOTHECON

250,000 UNITS/5ML

A060307

003

200,000 UNITS/5ML

A062149

001

400,000 UNITS/5ML

A062149

002

400,000 UNITS/5ML

A060587

001

1,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
10,000,000 UNITS/VIAL
20,000,000 UNITS/VIAL
500,000 UNITS/VIAL
1,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
10,000,000 UNITS/VIAL
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
1,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
10,000,000 UNITS/VIAL
20,000,000 UNITS/VIAL
1,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
20,000,000 UNITS/VIAL
1,000,000 UNITS/VIAL

A060362
A060362
A060362
A060362
A060806
A060806
A060806
A060806
A060384
A060384
A060384
A060384
A060384
A060601
A062991
A062991
A062991
A062991
A062003
A062003
A060074
A065079

001
003
004
002
001
002
003
004
004
003
002
001
005
001
001
002
003
004
001
002
003
001

1,000,000 UNITS/VIAL

A060657

001

250,000
400,000
250,000
200,000
250,000
400,000
500,000
800,000
200,000
250,000
400,000
200,000
250,000
400,000
500,000
200,000
250,000
400,000

UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS

A060392
A060073
A060403
A060781
A060781
A060781
A060781
A060781
A061588
A061588
A061588
A060306
A060306
A060306
A060306
A060413
A060413
A060413

003
004
001
001
002
003
005
004
001
002
003
001
002
003
004
001
002
003

200,000 UNITS

A062155

001

250,000 UNITS

A062155

002

400,000 UNITS
400,000 UNITS

A060392
A062155

004
003

Sep
Sep
Sep
Sep

13,
13,
13,
13,

1988
1988
1988
1988

Aug 30, 2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 257 (of 346)

PENICILLIN G POTASSIUM
TABLET; ORAL
PENTIDS '800'
APOTHECON
PFIZERPEN G
PFIZER

800,000 UNITS
800,000 UNITS

A060392
A062155

005
004

50,000 UNITS
100,000 UNITS
200,000 UNITS
250,000 UNITS
400,000 UNITS
800,000 UNITS

A060075
A060075
A060075
A060075
A060075
A060075

001
002
003
004
005
006

300,000 UNITS/ML

A060093

001

300,000 UNITS/ML
600,000 UNITS/1.2ML
300,000 UNITS/ML
300,000 UNITS/VIAL
1,500,000 UNITS/VIAL

A060800
A060800
A062029
A060099
A060099

001
002
001
001
002

300,000 UNITS/ML
600,000 UNITS/ML

A060286
A060286

001
002

5,000,000 UNITS/VIAL

A063014

001

5,000,000 UNITS/VIAL
5,000,000 UNITS/VIAL
1,000,000 UNITS/VIAL

A061935
A061051
A061046

001
001
001

125MG/0.6ML

A060002

001

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

A062270
A062270

001
002

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

A061149
A061149

001
002

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

A060136
A060136

001
002

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

A062002
A062002

001
002

EQ
EQ
EQ
EQ
EQ
EQ

A061529
A061529
A061624
A061624
A061758
A061758

001
002
002
001
001
002

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
PENAPAR-VK
PARKE DAVIS
PENICILLIN V POTASSIUM
AM ANTIBIOTICS
MYLAN
PUREPAC PHARM

125MG
250MG
125MG
250MG
125MG
250MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

Sep 13, 1988

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 258 (of 346)

PENICILLIN V POTASSIUM
FOR SOLUTION; ORAL
PEN-VEE K
WYETH AYERST
PFIZERPEN VK
PFIZER
V-CILLIN K
LILLY
VEETIDS
APOTHECON
VEETIDS '125'
APOTHECON
VEETIDS '250'
APOTHECON
TABLET; ORAL
BEEPEN-VK
GLAXOSMITHKLINE
BETAPEN-VK
BRISTOL
LEDERCILLIN VK
LEDERLE
PENAPAR-VK
PARKE DAVIS
PENICILLIN V POTASSIUM
AM ANTIBIOTICS
IVAX SUB TEVA PHARMS

MYLAN
PUREPAC PHARM

PEN-VEE K
WYETH AYERST

PFIZERPEN VK
PFIZER
UTICILLIN VK
PHARMACIA AND UPJOHN
V-CILLIN K
LILLY

VEETIDS
APOTHECON
VEETIDS '250'
APOTHECON

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

A060007
A060007

001
002

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

A061815
A061815

001
002

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

A060004
A060004

001
002

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

A061410
A061410

001
002

EQ 125MG BASE/5ML
EQ 125MG BASE/5ML

A061206
A062153

001
001

EQ 250MG BASE/5ML
EQ 250MG BASE/5ML

A061206
A062153

002
002

EQ 250MG BASE
EQ 500MG BASE

A062273
A062273

001
002

EQ 250MG BASE
EQ 500MG BASE

A061150
A061150

001
002

EQ 250MG BASE
EQ 500MG BASE

A060134
A060134

001
002

EQ 250MG BASE
EQ 500MG BASE

A062001
A062001

001
002

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A061528
A061528
A060518
A060518
A060518
A061530
A061530
A061571
A061571
A061571

001
002
001
002
003
001
002
001
002
003

EQ 125MG BASE
EQ 250MG BASE
EQ 500MG BASE

A060006
A060006
A060006

001
002
003

EQ 250MG BASE
EQ 500MG BASE

A061836
A061836

001
002

EQ 250MG BASE
EQ 500MG BASE

A061651
A061651

001
002

EQ 125MG BASE
EQ 250MG BASE
EQ 500MG BASE

A060003
A060003
A060003

001
002
003

EQ 250MG BASE
EQ 500MG BASE

A061411
A061411

001
002

EQ 250MG BASE

A061164

001

250MG
500MG
125MG
250MG
500MG
250MG
500MG
125MG
250MG
500MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 259 (of 346)

PENICILLIN V POTASSIUM
TABLET; ORAL
VEETIDS '250'
APOTHECON
VEETIDS '500'
APOTHECON

EQ 250MG BASE

A062156

002

EQ 500MG BASE
EQ 500MG BASE

A061164
A062156

002
001

0.25MG/ML

N017048

001

600MG/VIAL

N019887

002

Mar 22, 1996

300MG/VIAL

A073447

001

Apr 28, 1994

300MG/VIAL
300MG/VIAL

A073617
A073479

001
001

Dec 18, 1995

Jun 30, 1992

EQ 50MG BASE

N016732

001

N021749

001

2mCi/ML

N017518

001

SOLUTION; INHALATION, INTRAVENOUS

PENTETATE ZINC TRISODIUM
HAMELN PHARMS
EQ 1GM BASE/5ML (EQ 200MG BASE/ML)

N021751

001

18.2MG/5ML

A083244

001

30MG
50MG
100MG

A084095
A084093
A083245

001
001
001

50MG
100MG
100MG
100MG

A085937
A085915
A083284
A083338

001
001
001
001

100MG
100MG

A084590
A083368

001
001

PENTAGASTRIN
INJECTABLE; INJECTION
PEPTAVLON
WYETH AYERST

PENTAMIDINE ISETHIONATE
FOR SOLUTION; INHALATION
NEBUPENT
APP PHARMS
INJECTABLE; INJECTION
PENTACARINAT
ARMOUR PHARM
PENTAMIDINE ISETHIONATE
BAXTER HLTHCARE
HOSPIRA

PENTAZOCINE HYDROCHLORIDE
TABLET; ORAL
TALWIN 50
SANOFI AVENTIS US

PENTETATE CALCIUM TRISODIUM

SOLUTION; INHALATION, INTRAVENOUS
PENTETATE CALCIUM TRISODIUM
HAMELN PHARMS
EQ 1GM BASE/5ML (EQ 200MG BASE/ML)

Aug 11, 2004

PENTETATE CALCIUM TRISODIUM YB-169

INJECTABLE; INJECTION
YTTERBIUM YB 169 DTPA
3M

PENTETATE ZINC TRISODIUM

PENTOBARBITAL
ELIXIR; ORAL
NEMBUTAL
OVATION PHARMS

PENTOBARBITAL SODIUM
CAPSULE; ORAL
NEMBUTAL SODIUM
OVATION PHARMS

PENTOBARBITAL SODIUM
LANNETT
VITARINE
WHITEWORTH TOWN PLSN
SODIUM PENTOBARBITAL
ANABOLIC
ELKINS SINN

Aug 11, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 260 (of 346)

PENTOBARBITAL SODIUM
CAPSULE; ORAL
SODIUM PENTOBARBITAL
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
OVATION PHARMS

TABLET; ORAL
PENTOBARBITAL SODIUM
VITARINE
SODIUM PENTOBARBITAL
NEXGEN PHARMA INC

100MG
100MG
50MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG

A083259
A084677
A083461
A083461
A084156
A084560
A083301
A083264
A085791
A083239

001
001
001
002
001
001
001
001
001
001

50MG/ML

A083270

001

50MG/ML

A083261

001

30MG
60MG
120MG
200MG

A083247
A083247
A083247
A083247

001
002
003
004

100MG

A083285

001

100MG

A084238

001

10MG/ML

N009372

001

400MG
400MG
400MG

A074878
A074877
A075199

001
001
001

Jul 09, 1997

Jul 08, 1997
Sep 03, 1999

100%

N020091

001

Aug 13, 1993

N021084

001

Feb 17, 2000

0.05MG BASE
0.25MG BASE
1MG BASE
0.05MG BASE
0.25MG BASE
1MG BASE

A076094
A076094
A076094
A076061
A076061
A076061

001
002
003
001
002
003

Sep
Sep
Sep
Nov
Nov
Nov

EQ 0.05MG BASE

N019385

001

Dec 30, 1988

Jan
Jan
Jan
Jan

25,
25,
25,
25,

1982
1982
1982
1982

PENTOLINIUM TARTRATE
INJECTABLE; INJECTION
ANSOLYSEN
WYETH AYERST

PENTOXIFYLLINE
TABLET, EXTENDED RELEASE;
PENTOXIFYLLINE
ACTAVIS ELIZABETH
HERITAGE PHARMS INC
TEVA

ORAL

PERFLUBRON
LIQUID; ORAL
IMAGENT
ALLIANCE PHARM

PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE

PASTE; TOPICAL
SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS
US ARMY
50%;50%

PERGOLIDE MESYLATE
TABLET; ORAL
PERGOLIDE MESYLATE
IVAX SUB TEVA PHARMS

PAR PHARM

PERMAX
VALEANT PHARM INTL

EQ
EQ
EQ
EQ
EQ
EQ

04,
04,
04,
27,
27,
27,

2003
2003
2003
2002
2002
2002

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 261 (of 346)

PERGOLIDE MESYLATE
TABLET; ORAL
PERMAX
VALEANT PHARM INTL

EQ 0.25MG BASE
EQ 1MG BASE

N019385
N019385

002
003

Dec 30, 1988

Dec 30, 1988

1%

N019435

001

Mar 31, 1986

16MG/5ML

A040360

001

May 25, 2001

16MG/5ML

N011557

001

5MG/ML

N011213

002

2MG/5ML

N011294

002

2MG
4MG
8MG
16MG

A089707
A089708
A089456
A089457

001
001
001
001

2MG
4MG
8MG
16MG
TABLET, EXTENDED RELEASE; ORAL
TRILAFON
SCHERING
8MG

N010775
N010775
N010775
N010775

001
002
003
004

N011361

002

N007707

001

N013294

001

Sep 10, 1987

TABLET; ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PENAZOPYRIDINE HYDROCHLORIDE
ABLE
200MG,N/A,N/A;N/A,800MG,160MG
N021105

001

Jun 26, 2001

Aug 31, 1990

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

Sep
Sep
Sep
Sep

10,
10,
10,
10,

1987
1987
1987
1987

PHENACEMIDE
TABLET; ORAL
PHENURONE
ABBOTT

500MG

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE

TABLET; ORAL
AZO GANTANOL
ROCHE

100MG;500MG

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE; TRIMETHOPRIM

PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE

TABLET; ORAL
AZO GANTRISIN
ROCHE

50MG;500MG

N019358

001

35MG
35MG

A086523
A086524

001
001

PHENDIMETRAZINE TARTRATE
CAPSULE; ORAL
PHENAZINE
MAST MM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 262 (of 346)

PHENDIMETRAZINE TARTRATE
CAPSULE; ORAL
PHENAZINE
MAST MM
35MG
PHENDIMETRAZINE TARTRATE
SANDOZ
35MG
35MG
35MG
35MG
VITARINE
35MG
35MG
35MG
35MG
35MG
35MG
35MG
SPRX-3
SOLVAY
35MG
STATOBEX
TEVA
35MG
X-TROZINE
SHIRE RICHWOOD
35MG
CAPSULE, EXTENDED RELEASE; ORAL
MELFIAT-105
NUMARK
105MG
PHENDIMETRAZINE TARTRATE
GRAHAM DM
105MG
105MG
105MG
105MG
105MG
105MG
SANDOZ
105MG
SPRX-105
NUMARK
105MG
X-TROZINE L.A.
SHIRE RICHWOOD
105MG
TABLET; ORAL
ADPHEN
FERNDALE LABS
35MG
ALPHAZINE
SANDOZ
35MG
CAM-METRAZINE
ABC HOLDING
35MG
CAMALL
35MG
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

A086525

001

A085633
A085694
A085695
A085702
A085634
A085645
A085670
A086403
A086408
A086410
A087424

001
001
001
001
001
001
001
001
001
001
001

A085897

001

A085507

001

A087394

001

Sep 22, 1982

A087487

001

Oct 13, 1982

A087214
A088020
A088028
A088062
A088063
A088111
A087378

001
001
001
001
001
001
001

May
Aug
Aug
Sep
Sep
Oct

A088024

001

Dec 22, 1982

A087371

001

Aug 24, 1982

A083655

001

A085034

001

A085511
A085756
A083922
A085318
A085320
A085321

001
001
001
001
001
001

A085698

001

A083790

002

A083754

001

A087305

001

A085512

001

A083644
A083684
A083686
A083687

001
001
001
001

26,
16,
16,
13,
10,
18,

1982
1982
1982
1982
1982
1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 263 (of 346)

PHENDIMETRAZINE TARTRATE
TABLET; ORAL
PHENDIMETRAZINE TARTRATE
BARR
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

A084831
A084834
A084835
A086834
A084740
A084741
A084742
A084743
A085611
A085612
A083682
A084138
A084141
A085525
A085914
A086020
A083790
A085199
A085697
A085402
A085497
A085830
A086365
A086370
A083993
A085761
A085941
A083805
A084398
A084399
A085519
A086005
A086106
A085767
A085768
A085770
A085773

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

N012248

001

A086013

001

A085095

001

A086550
A086551
A086552
A086553
A086554

001
001
001
001
001

N008767

002

N010460

005

PHENINDIONE
TABLET; ORAL
HEDULIN
SANOFI AVENTIS US

50MG

PHENMETRAZINE HYDROCHLORIDE
TABLET; ORAL
PRELUDIN
BOEHRINGER INGELHEIM

25MG

Sep 15, 1983

Jun 27, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 264 (of 346)

PHENMETRAZINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
PRELUDIN
BOEHRINGER INGELHEIM 50MG
75MG

N011752
N011752

004
003

3MG

N011228

001

500MG

N008855

004

30MG

N017352

001

30MG

A087144

001

30MG

A087764

001

A086511
A086516

001
001

A085411
A040497
A040403
A040427
A040460
A040227
A040448
A040228
A086735
A087226
A088948
A086329
A040527
A087208
A087223
A088414
A086911
A087126
A087777
A088612
A088613
A088614
A040083
A088576
A085417
A086732
A087215
A087915
A087918
A087930
A088610
A088611
A088625
A084487
A088430

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
001

PHENPROCOUMON
TABLET; ORAL
LIQUAMAR
ORGANON USA INC

PHENSUXIMIDE
CAPSULE; ORAL
MILONTIN
PARKE DAVIS

PHENTERMINE HYDROCHLORIDE
CAPSULE; ORAL
FASTIN
GLAXOSMITHKLINE
OBESTIN-30
FERNDALE LABS
OBY-TRIM
SHIRE RICHWOOD
ONA-MAST
MAST MM

30MG
30MG
PHENTERMINE HYDROCHLORIDE
ABC HOLDING
30MG
ABLE
15MG
30MG
30MG
ACTAVIS TOTOWA
15MG
30MG
30MG
37.5MG
CAMALL
15MG
30MG
DURAMED PHARMS BARR
30MG
IVAX PHARMS
30MG
MUTUAL PHARM
37.5MG
SANDOZ
30MG
30MG
37.5MG
TEVA
30MG
30MG
30MG
30MG
30MG
30MG
TG UNITED INC
30MG
TG UNITED LABS
18.75MG
30MG
30MG
30MG
37.5MG
37.5MG
37.5MG
37.5MG
37.5MG
37.5MG
USL PHARMA
30MG
30MG

Mar 18, 1982

Mar
Aug
Aug
Jan
Jun
Jan
Jun

13,
30,
30,
14,
18,
22,
19,

2003
2001
2001
2003
1997
2003
1997

Apr 25, 1986

Oct 23, 2003

Oct 19, 1983

Nov
Apr
Apr
Apr
Mar
May

01,
04,
09,
09,
07,
23,

1985
1984
1984
1984
1997
1984

Dec
Dec
Oct
Jun
Jun
Aug
Apr
Mar

22,
22,
14,
04,
04,
23,
09,
27,

1983
1983
1983
1984
1984
1984
1982
1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 265 (of 346)

PHENTERMINE HYDROCHLORIDE
CAPSULE; ORAL
PHENTERMINE HYDROCHLORIDE
USL PHARMA
30MG
VITARINE
30MG
30MG
WATSON LABS
30MG
TABLET; ORAL
ONA-MAST
MAST MM
8MG
PHENTERMINE HYDROCHLORIDE
ABLE
37.5MG
ACTAVIS TOTOWA
37.5MG
IVAX PHARMS
8MG
SANDOZ
8MG
8MG
TG UNITED LABS
8MG
8MG
37.5MG
37.5MG
USL PHARMA
8MG
37.5MG
37.5MG
VITARINE
8MG
8MG
WATSON LABS
8MG
TORA
SOLVAY
8MG
WILPO
SANDOZ
8MG

A088797
A087202
A087235
A086740

001
001
001
001

A086260

001

A040402
A040190
A085553
A085671
A085689
A083923
A085319
A087805
A088596
A083804
A088910
A088917
A086453
A086456
A085739

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

A084035

001

N012737

001

N011613
N011613

004
002

A089120

001

50%

N011695

002

500MG

N011695

003

100MG

A087260

001

100MG

N008319

009

100MG
100MG
100MG
100MG

A088218
A088994
A087774
A087756

001
001
001
001

100MG

A087091

001

100MG

N008319

008

Dec 10, 1984

Mar 21, 1985

Aug 30, 2001

May 30, 1997

Dec 06, 1982

Apr 04, 1984
Jul 17, 1985
Jul 17, 1985

PHENTERMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE; ORAL
IONAMIN
UCB INC
EQ 15MG BASE
EQ 30MG BASE
PHENTERMINE RESIN 30
QUANTUM PHARMICS
EQ 30MG BASE

Feb 04, 1988

PHENYL AMINOSALICYLATE
POWDER; ORAL
PHENY-PAS-TEBAMIN
PHARM RES ASSOC
TABLET; ORAL
PHENY-PAS-TEBAMIN
PHARM RES ASSOC

PHENYLBUTAZONE
CAPSULE; ORAL
AZOLID
SANOFI AVENTIS US
BUTAZOLIDIN
NOVARTIS
PHENYLBUTAZONE
IVAX PHARMS
MUTUAL PHARM
SANDOZ
WATSON LABS
TABLET; ORAL
AZOLID
SANOFI AVENTIS US
BUTAZOLIDIN
NOVARTIS

Jun
Dec
Jun
Dec

24,
04,
16,
17,

1983
1985
1982
1982

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 266 (of 346)

PHENYLBUTAZONE
TABLET; ORAL
PHENYLBUTAZONE
MUTUAL PHARM
SANDOZ
WATSON LABS

100MG
100MG
100MG
100MG

A088863
A084339
A086151
A087674

001
001
001
001

Dec 04, 1985

5MG/5ML;6.25MG/5ML

N008604

003

Apr 02, 1984

5MG/5ML;6.25MG/5ML

A088868

001

Mar 02, 1987

5MG/5ML;6.25MG/5ML
5MG/5ML;6.25MG/5ML

A088815
A088897

001
001

Nov 22, 1985

Jan 04, 1985

N007953

001

30MG/5ML

N008762

002

125MG/5ML

A089892

001

A080857
A080857

001
002

A040435
A089441

001
001

Jun 20, 2003

Dec 18, 1986

A088711

001

Dec 21, 1984

A085435
A085894

001
001

A080259
A080905

001
001

N010151

001

A089003
A089501
A089779
A088519
A088521
A088520
A089900
A085434

001
001
001
001
001
001
001
001

N012223

002

Apr 21, 1982

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP; ORAL
PHENERGAN VC
ANI PHARMS
PHERAZINE VC
HALSEY
PROMETHAZINE VC PLAIN
CENCI
WOCKHARDT

PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE

SOLUTION/DROPS; OPHTHALMIC
PREFRIN-A
ALLERGAN
0.12%;0.1%

PHENYTOIN
SUSPENSION; ORAL
DILANTIN-30
PARKE DAVIS
PHENYTOIN
ACTAVIS MID ATLANTIC

Sep 25, 1992

PHENYTOIN SODIUM
CAPSULE; ORAL
DIPHENYLAN SODIUM
LANNETT

30MG PROMPT
100MG PROMPT
EXTENDED PHENYTOIN SODIUM
BARR
100MG EXTENDED
PLIVA
100MG EXTENDED
PHENYTEX
WATSON LABS
100MG EXTENDED
PHENYTOIN SODIUM
PHARMERAL
100MG PROMPT
WATSON LABS
100MG PROMPT
PROMPT PHENYTOIN SODIUM
IVAX SUB TEVA PHARMS 100MG PROMPT
WATSON LABS
100MG PROMPT
INJECTABLE; INJECTION
DILANTIN
PARKE DAVIS
50MG/ML
PHENYTOIN SODIUM
APP PHARMS
50MG/ML
MARSAM PHARMS LLC
50MG/ML
50MG/ML
SMITH AND NEPHEW
50MG/ML
50MG/ML
SOLOPAK
50MG/ML
WARNER CHILCOTT
50MG/ML
WATSON LABS
50MG/ML

PHYTONADIONE
INJECTABLE; INJECTION
AQUAMEPHYTON
BIOVAIL TECHNOLOGIES

1MG/0.5ML

May
Oct
Nov
Dec
Dec
Dec
Mar

31,
13,
27,
19,
18,
17,
30,

1985
1987
1992
1984
1984
1984
1990

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 267 (of 346)

PHYTONADIONE
INJECTABLE; INJECTION
AQUAMEPHYTON
BIOVAIL TECHNOLOGIES
KONAKION
ROCHE
PHYTONADIONE
GLAXOSMITHKLINE
VITAMIN K1
HOSPIRA

10MG/ML

N012223

001

1MG/0.5ML
10MG/ML

N011745
N011745

001
003

1MG/0.5ML
10MG/ML

A084060
A084060

001
002

10MG/ML

A087956

001

N017431

001

N017548

001

N019456
N019456

001
002

Dec 28, 1989

Dec 28, 1989

5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
5MG
10MG
10MG

A074013
A074018
A073687
A073687
A074063
A074063
A074474
A074474
A074125
A074125
A073608
A073609
A073661
A074123
A073661
A074123

001
001
001
002
001
002
001
002
001
002
001
001
001
001
002
002

Sep
Sep
Feb
Feb
Jan
Jan
Oct
Oct
Apr
Apr
Mar
Mar
Oct
Apr
Oct
Apr

5MG
10MG

N018285
N018285

001
002

Sep 03, 1982

Sep 03, 1982

10MG/VIAL

N019638

001

Jun 26, 1990

10MG
25MG

N013615
N013615

001
002

Jul 25, 1983

PILOCARPINE
INSERT, EXTENDED RELEASE; OPHTHALMIC
OCUSERT PILO-20
AKORN
5MG
OCUSERT PILO-40
AKORN
11MG

PINACIDIL
CAPSULE, EXTENDED RELEASE; ORAL
PINDAC
LEO PHARM
12.5MG
25MG

PINDOLOL
TABLET; ORAL
PINDOLOL
GENPHARM
IVAX SUB TEVA PHARMS
MUTUAL PHARM
NOSTRUM LABS
PUREPAC PHARM
SANDOZ
TEVA

VISKEN
NOVARTIS

24,
24,
26,
26,
27,
27,
28,
28,
28,
28,
29,
29,
31,
17,
31,
17,

1992
1992
1993
1993
1994
1994
1996
1996
1993
1993
1993
1993
1993
1997
1993
1997

PIPECURONIUM BROMIDE
INJECTABLE; INJECTION
ARDUAN
ORGANON USA INC

PIPERACETAZINE
TABLET; ORAL
QUIDE
DOW PHARM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 268 (of 346)

PIPERACILLIN SODIUM
INJECTABLE; INJECTION
PIPRACIL
WYETH PHARMS INC

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

A062750
N050545
A062750
N050545
A062750
N050545
N050545

001
002
002
003
003
004
006

EQ 500MG BASE/5ML

N009102

001

EQ 500MG BASE/5ML

N017796

001

EQ 500MG BASE/5ML

N009452

001

EQ 500MG BASE/5ML
EQ 500MG BASE/5ML
EQ 500MG BASE/5ML

A080774
A080963
A080671

001
001
001

EQ 500MG BASE/5ML

A080992

001

EQ 500MG BASE

N009102

003

EQ 250MG BASE

A080874

001

10MG
25MG

N016245
N016245

001
002

N019009

001

Dec 30, 1986

A074808
A074808
A074148
A074148
A073536
A074043
A074043
A073651
A073651
A074036
A074036
A073637
A073638
A074103
A074103

001
002
001
002
001
001
002
001
002
001
002
001
001
001
002

Jul
Jul
Jun
Jun
Mar
Sep
Sep
Feb
Feb
May
May
Jan
Jan
Aug
Aug

EQ
EQ
EQ
EQ
EQ
EQ
EQ

Oct 13, 1987

Oct 13, 1987
Oct 13, 1987
Sep 30, 1985

PIPERAZINE CITRATE
SYRUP; ORAL
ANTEPAR
GLAXOSMITHKLINE
BRYREL
SANOFI AVENTIS US
MULTIFUGE
BLULINE
PIPERAZINE CITRATE
ALPHARMA US PHARMS
LANNETT
LUITPOLD
VERMIDOL
SOLVAY
TABLET; ORAL
ANTEPAR
GLAXOSMITHKLINE
PIPERAZINE CITRATE
IMPAX LABS

PIPOBROMAN
TABLET; ORAL
VERCYTE
ABBOTT

PIRBUTEROL ACETATE
AEROSOL, METERED; INHALATION
MAXAIR
EQ 0.2MG BASE/INH
MEDICIS

PIROXICAM
CAPSULE; ORAL

PIROXICAM

EGIS

IVAX SUB TEVA PHARMS

MUTUAL PHARM
MYLAN
ROXANE
SCS
TEVA
TEVA PHARMS

10MG
20MG
10MG
20MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG

08,
08,
03,
03,
12,
22,
22,
26,
26,
29,
29,
28,
28,
28,
28,

1997
1997
1996
1996
1993
1992
1992
1993
1993
1992
1992
1994
1994
1992
1992

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DISCONTINUED DRUG PRODUCT LIST

6 - 269 (of 346)

PLICAMYCIN
INJECTABLE; INJECTION

MITHRACIN

PFIZER

2.5MG/VIAL

N050109

001

40MG/AMP

N010753

001

A077445

001

POLYESTRADIOL PHOSPHATE
INJECTABLE; INJECTION

ESTRADURIN

WYETH AYERST

POLYETHYLENE GLYCOL 3350

FOR SOLUTION; ORAL
POLYETHYLENE GLYCOL 3350
TEVA PHARMS
17GM/SCOOPFUL

May 04, 2006

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

SODIUM SULFATE
SOLUTION; ORAL
OCL
HOSPIRA

6GM/100ML;75MG/100ML;168MG/100ML;146MG/ N019284
100ML;1.29GM/100ML

001

Apr 30, 1986

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

SODIUM SULFATE ANHYDROUS
FOR SOLUTION; ORAL
COLYTE
MEDA PHARMS

FOR SUSPENSION; ORAL

CO-LAV
BOCA PHARMA
COLOVAGE
DYNAPHARM
E-Z-EM PREP LYTE
E Z EM
GLYCOPREP
GOLDLINE
GO-EVAC
BOCA PHARMA
PEG-LYTE
SANDOZ

120GM/PACKET;1.49GM/PACKET;3.36GM/PACKE N018983
T;2.92GM/PACKET;11.36GM/PACKET
227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC N018983
KET;5.53GM/PACKET;21.5GM/PACKET
360GM/PACKET;4.47GM/PACKET;10.08GM/PACK N018983
ET;8.76GM/PACKET;34.08GM/PACKET

005

Oct 26, 1984

004

Oct 26, 1984

006

Oct 26, 1984

240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ A073428
BOT;22.72GM/BOT

001

Jan 28, 1992

227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC A071320
KET;5.53GM/PACKET;21.5GM/PACKET

001

Apr 20, 1988

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A071278
BOT;22.74GM/BOT

001

Nov 21, 1988

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A072319
BOT;22.74GM/BOT

001

Dec 23, 1988

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A073433
BOT;22.74GM/BOT

001

Apr 28, 1992

236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A073098
BOT;22.74GM/BOT

001

Aug 31, 1993

POLYMYXIN B SULFATE
INJECTABLE; INJECTION
AEROSPORIN
GLAXOSMITHKLINE
EQ 500,000 U BASE/VIAL
POWDER; FOR RX COMPOUNDING
POLYMYXIN B SULFATE
PADDOCK LLC
100,000,000 UNITS/BOT

A062036

001

A062455

001

N012845
N012845
N012845

001

002

003

POLYTHIAZIDE
TABLET; ORAL

RENESE

PFIZER

1MG
2MG
4MG

Jul 27, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 270 (of 346)

POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE

CAPSULE; ORAL
MINIZIDE
PFIZER

0.5MG;EQ 1MG BASE

0.5MG;EQ 2MG BASE
0.5MG;EQ 5MG BASE

N017986
N017986
N017986

001
002
003

2MG;0.25MG

N013636

001

N009395

004

A080098

001

N009395

003

A073398
A072427

001
001

Jan 28, 1992

Mar 28, 1990

A070980
A073531
A073532

001
001
001

Feb 17, 1987

Apr 26, 1996
Apr 26, 1996

N019561

003

Aug 26, 1988

A080204
A084290
A086713
A086714
A087787
A087885
A088286
A087817
A080203
A086219
A086219
A086220
A086219
A086220
A086219
A080205
A083345
A083345
A083345
A080205
A080205
N007865
A080221
A080736
A087584
A087585
A080195

001
001
001
001
001
001
001
001
001
001
002
002
003
001
004
003
003
001
002
004
005
002
001
001
001
001
002

POLYTHIAZIDE; RESERPINE
TABLET; ORAL
RENESE-R
PFIZER

POTASSIUM AMINOSALICYLATE
CAPSULE; ORAL
PASKALIUM
GLENWOOD
500MG
POWDER; ORAL
POTASSIUM AMINOSALICYLATE
HEXCEL
100%
TABLET; ORAL
PASKALIUM
GLENWOOD
1GM

POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
K-LEASE
SAVAGE LABS
8MEQ
10MEQ
POTASSIUM CHLORIDE
NESHER PHARMS
10MEQ
TEVA
8MEQ
10MEQ
FOR SUSPENSION, EXTENDED RELEASE; ORAL
MICRO-K LS
KV PHARM
20MEQ/PACKET
INJECTABLE; INJECTION
POTASSIUM CHLORIDE
ABRAXIS PHARM
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
AKORN
2MEQ/ML
APP PHARMS
2MEQ/ML
BAXTER HLTHCARE
2MEQ/ML
GD SEARLE LLC
1MEQ/ML
2MEQ/ML
2MEQ/ML
3MEQ/ML
3MEQ/ML
4MEQ/ML
HOSPIRA
1MEQ/ML
1MEQ/ML
1.5MEQ/ML
2MEQ/ML
2.4MEQ/ML
3.2MEQ/ML
LILLY
2MEQ/ML
LUITPOLD
2MEQ/ML
2MEQ/ML
2MEQ/ML
2MEQ/ML
MILES
1MEQ/ML

Apr
Feb
Sep
Oct

20,
03,
05,
20,

1982
1983
1985
1982

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6 - 271 (of 346)

POTASSIUM CHLORIDE
INJECTABLE; INJECTION
POTASSIUM CHLORIDE
MILES

2MEQ/ML
3MEQ/ML
4MEQ/ML
PHARMA SERVE NY
2MEQ/ML
2MEQ/ML
WATSON LABS
2MEQ/ML
2MEQ/ML
2MEQ/ML
3MEQ/ML
TABLET, EXTENDED RELEASE; ORAL
K+8
FUTURE PAK
8MEQ
KAON CL
SAVAGE LABS
6.7MEQ
POTASSIUM CHLORIDE
COPLEY PHARM
8MEQ
SLOW-K
NOVARTIS
8MEQ
TEN-K
NOVARTIS
10MEQ

A080195
A080195
A080195
A086297
A087362
A086208
A089163
A089421
A086210

001
003
004
001
001
001
001
001
001

Mar 08, 1983

A070998

001

Jan 25, 1993

N017046

001

A070618

001

N017476

002

N019381

001

Apr 16, 1986

001

Sep 29, 1989

002

Sep 29, 1989

003

Sep 29, 1989

005

Sep 29, 1989

006

Sep 29, 1989

001
004

Nov 09, 1982

002

Nov 09, 1982

003

Nov 09, 1982

004

Nov 09, 1982

Mar 10, 1988

Jan 02, 1987

Sep 09, 1987

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
POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
75MG/100ML;900MG/100ML
N019708
POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
110MG/100ML;900MG/100ML
N019708
POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
220MG/100ML;900MG/100ML
N019708
POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN
300MG/100ML;900MG/100ML
N019708
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
B BRAUN
75MG/100ML;900MG/100ML
N018722
BAXTER HLTHCARE
75MG/100ML;900MG/100ML
N017648
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN
150MG/100ML;900MG/100ML
N018722
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
B BRAUN
220MG/100ML;900MG/100ML
N018722
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN
300MG/100ML;900MG/100ML
N018722

POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

INJECTABLE; INJECTION
THAM-E
HOSPIRA

370MG/VIAL;1.75GM/VIAL;36GM/VIAL

N013025

001

10MEQ/PACKET
20MEQ/PACKET

N019647
N019647

002
001

Oct 13, 1988

Oct 13, 1988

1GM/ML

N018551

001

Feb 19, 1982

POTASSIUM CITRATE
FOR SOLUTION; ORAL
POTASSIUM CITRATE
UNIV TX SW MEDCTR

POTASSIUM IODIDE
SOLUTION; ORAL
POTASSIUM IODIDE
ROXANE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 272 (of 346)

POTASSIUM IODIDE
TABLET; ORAL
THYRO-BLOCK
MEDPOINTE PHARM HLC

130MG

N018307

001

200MG

N017551

001

10%

N019382

001

Jul 25, 1989

5%

N019382

002

Jul 25, 1989

5%

N019382

003

Jul 25, 1989

300MG/ML

N018799

001

Dec 13, 1982

500MG

N014122

002

1.25MG

N020667

004

Jul 01, 1997

5MG
10MG
20MG

N018144
N018144
N018144

001
002
003

May 10, 1982

5MG
10MG

A070427
A070428

001
001

Nov 06, 1987

Nov 06, 1987

10MG

N017415

001

A072782
A072783
A072784
A072705
A072706
A072707
A072991
A072921
A072992
A072576
A072577
A072578
A072352
A072333

001
001
001
001
001
001
001
001
001
001
001
001
001
001

POTASSIUM PERCHLORATE
CAPSULE; ORAL
PERCHLORACAP
MALLINCKRODT

POVIDONE-IODINE
SOLUTION; TOPICAL
E-Z PREP
CLINIPAD
SPONGE; TOPICAL
E-Z PREP
CLINIPAD
E-Z PREP 220
CLINIPAD

PRALIDOXIME CHLORIDE
INJECTABLE; INJECTION
PRALIDOXIME CHLORIDE
BAXTER HLTHCARE CORP
TABLET; ORAL
PROTOPAM CHLORIDE
WYETH AYERST

PRAMIPEXOLE DIHYDROCHLORIDE
TABLET; ORAL
MIRAPEX
BOEHRINGER INGELHEIM

PRAZEPAM
CAPSULE; ORAL
CENTRAX
PARKE DAVIS

PRAZEPAM
USL PHARMA
TABLET; ORAL
CENTRAX
PARKE DAVIS

PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL
PRAZOSIN HYDROCHLORIDE
AM THERAP

CLONMEL HLTHCARE

PUREPAC PHARM

SANDOZ

WATSON LABS

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

1MG
2MG
5MG
1MG
2MG
5MG
1MG
2MG
5MG
1MG
2MG
5MG
1MG
2MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

May
May
May
May
May
May
May
May
May
May
May
May
May
May

16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,
16,

1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989

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DISCONTINUED DRUG PRODUCT LIST

6 - 273 (of 346)

PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL
PRAZOSIN HYDROCHLORIDE
WATSON LABS
EQ 5MG BASE
TABLET, EXTENDED RELEASE; ORAL
MINIPRESS XL
PFIZER
2.5MG
5MG

A072609

001

May 16, 1989

N019775
N019775

001
002

Jan 29, 1992

Jan 29, 1992

0.5%

N010209

002

15MG/5ML
15MG/5ML
15MG/5ML

A040287
A040322
A040192

001
001
001

May 28, 1999

Jan 19, 2000
May 28, 1998

5MG/5ML

A089654

001

Jan 17, 1989

1MG
2.5MG
5MG

A080304
A080304
A080304

003
002
001

5MG

N009987

004

5MG

A083941

001

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

A084426
A083675
A080625
A084439
A084439
A084439
A080562
A080562
A080326
A080780
A080748
A080378
A080531
A080307
A080351
A080351
A084542
A080322
A080325
A080211
A080327
A080339
A084773
A080358
A080358
A080358
A088892
A085170
A080398
A087987
A080236
A080534
A085085
A085415

002
001
001
001
002
003
001
002
001
001
001
001
002
001
001
002
001
001
001
001
002
001
001
001
002
003
001
001
001
001
001
001
002
001

PREDNISOLONE
CREAM; TOPICAL
METI-DERM
SCHERING
SYRUP; ORAL
PREDNISOLONE
IVAX SUB TEVA PHARMS
TEVA PHARMS
WE PHARMS
PRELONE
MURO
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

Feb 26, 1985

Jan 18, 1983

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6 - 274 (of 346)

PREDNISOLONE
TABLET; ORAL
PREDNISOLONE
WATSON LABS
WEST WARD
WHITEWORTH TOWN PLSN
STERANE
PFIZER

5MG
5MG
5MG

A085416
A080324
A080342

001
001
001

5MG

N009996

001

25MG/ML

N010255

002

25MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG/ML
25MG/ML
40MG/ML
50MG/ML
50MG/ML

A083032
A084492
A083738
A083738
A084717
A084717
A083398
A083654
A083767
A083764
A085781

001
001
001
002
001
002
001
001
001
001
001

N011446

001

N022067

001

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

PREDNISOLONE ACETATE
INJECTABLE; INJECTION
METICORTELONE
SCHERING
PREDNISOLONE ACETATE
AKORN
BEL MAR
CENT PHARMS
WATSON LABS

STERANE
PFIZER
25MG/ML
SUSPENSION; ORAL
FLO-PRED
TARO
EQ 5MG BASE/5ML
SUSPENSION/DROPS; OPHTHALMIC
ECONOPRED
ALCON
0.125%

Jan 17, 2008

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

OINTMENT; OPHTHALMIC
CETAPRED
ALCON
0.25%;10%
METIMYD
SCHERING
0.5%;10%
PREDSULFAIR
PHARMAFAIR
0.5%;10%
VASOCIDIN
NOVARTIS
0.5%;10%
SUSPENSION; OPHTHALMIC
ISOPTO CETAPRED
ALCON
0.25%;10%
SUSPENSION/DROPS; OPHTHALMIC
METIMYD
SCHERING
0.5%;10%
PREDAMIDE
AKORN
0.5%;10%
PREDSULFAIR
PHARMAFAIR
0.5%;10%
PREDSULFAIR II
PHARMAFAIR
0.2%;10%
SULPHRIN
BAUSCH AND LOMB
0.5%;10%

PREDNISOLONE SODIUM PHOSPHATE

INJECTABLE; INJECTION
HYDELTRASOL
MERCK

EQ 20MG PHOSPHATE/ML

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6 - 275 (of 346)

PREDNISOLONE SODIUM PHOSPHATE

INJECTABLE; INJECTION
PREDNISOLONE SODIUM PHOSPHATE
WATSON LABS
EQ 20MG PHOSPHATE/ML
OINTMENT; OPHTHALMIC, OTIC
HYDELTRASOL
MERCK
EQ 0.25% PHOSPHATE
SOLUTION; ORAL
PREDNISOLONE SODIUM PHOSPHATE
VINTAGE PHARMS
EQ 5MG BASE/5ML
WE PHARMS
EQ 5MG BASE/5ML
SOLUTION/DROPS; OPHTHALMIC
INFLAMASE FORTE
NOVARTIS
EQ 0.9% PHOSPHATE
INFLAMASE MILD
NOVARTIS
EQ 0.11% PHOSPHATE
METRETON
SCHERING
EQ 0.5% PHOSPHATE
PREDAIR
PHARMAFAIR
EQ 0.11% PHOSPHATE
PREDAIR FORTE
PHARMAFAIR
EQ 0.9% PHOSPHATE
PREDNISOLONE SODIUM PHOSPHATE
AKORN
EQ 0.11% PHOSPHATE
EQ 0.9% PHOSPHATE
ALCON UNIVERSAL
EQ 0.11% PHOSPHATE
EQ 0.9% PHOSPHATE
BAUSCH AND LOMB
EQ 0.11% PHOSPHATE
SOLA BARNES HIND
EQ 0.11% PHOSPHATE
EQ 0.9% PHOSPHATE
EQ 0.9% PHOSPHATE
EQ 0.9% PHOSPHATE

A080517

001

N011028

001

A078416
A075181

001
001

A080751

002

A080751

001

A083834

001

A088415

001

Feb 29, 1984

A088165

001

Mar 28, 1983

A083358
A083358
A081043
A081044
A040065
A084171
A084168
A084169
A084172

001
002
001
001
001
001
001
001
001

A074511

001

20MG/ML

N010562

001

20MG/ML

A083362

001

Feb 17, 1984

5MG/5ML

A089726

001

Aug 02, 1988

5MG/5ML

A087611

002

Sep 07, 1982

20MG

A087480

001

5MG

A080293

001

2.5MG
5MG
10MG
20MG
50MG

N009986
N009986
N009986
N009986
N009986

005
002
006
007
008

Oct 31, 2007

Dec 23, 2002

Oct 24, 1991

Oct 24, 1991
Jul 29, 1994

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

SOLUTION/DROPS; OPHTHALMIC
SULSTER
AKORN
EQ 0.23% PHOSPHATE;10%

Jul 30, 1996

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

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6 - 276 (of 346)

PREDNISONE
TABLET; ORAL
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

IVAX SUB TEVA PHARMS

KV PHARM
LANNETT
LEDERLE
MARSHALL PHARMA
MUTUAL PHARM

NYLOS
PANRAY

PERRIGO
PHARMAVITE

5MG

A083364

001

1MG
5MG

N009766
N009766

002
001

1MG
5MG
10MG
20MG
50MG

A083009
A083009
A083009
A083009
A085999

001
002
003
004
001

5MG

N010962

002

5MG

A084655

001

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
5MG
10MG
20MG
5MG
5MG
20MG
5MG
5MG
5MG
10MG
20MG
50MG
5MG
1MG
2.5MG
5MG
5MG
5MG

A089387
A089388
A089389
A089597
A089598
A089599
A083676
A088394
A088395
A088396
A080491
A085811
A084440
A084440
A084440
A080563
A080563
A080300
A080320
A084341
A084417
A085543
A086946
A080782
A080328
A080306
A080279
A080283
A084133
A084134
A084236
A080514
A084275
A086968
A080301
A080701
A086595
A084634
A086596
A085115
A080350
A080350
A080350
A083059
A084662

001
001
001
001
001
001
001
001
001
001
001
001
001
002
003
001
002
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
003
001
002

Nov
Nov
Nov
Oct
Oct
Oct

06,
06,
06,
05,
05,
05,

1986
1986
1986
1987
1987
1987

Oct 04, 1983

Oct 04, 1983
Oct 04, 1983

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6 - 277 (of 346)

PREDNISONE
TABLET; ORAL
PREDNISONE
PHOENIX LABS NY
PUREPAC PHARM

PVT FORM
REXALL
ROXANE
SANDOZ

SCHERER LABS
SPERTI

SUPERPHARM

TEVA
UDL

UPSHER SMITH
VALEANT PHARM INTL
VANGARD
VITARINE
WATSON LABS

WEST WARD
WHITEWORTH TOWN PLSN

SERVISONE
LEDERLE

5MG
20MG
5MG
10MG
20MG
20MG
5MG
20MG
25MG
5MG
5MG
10MG
20MG
50MG
5MG
1MG
2.5MG
5MG
5MG
10MG
20MG
5MG
5MG
10MG
20MG
5MG
20MG
5MG
5MG
20MG
5MG
5MG
5MG
10MG
20MG
50MG
50MG
50MG
2.5MG
5MG
10MG
20MG

A080321
A083807
A080353
A086062
A086061
A085151
A080232
N017109
A087833
A080336
A084774
A089983
A085813
A089984
A080371
A080359
A080359
A080359
A088865
A088866
A088867
A080397
A087984
A087985
A087986
A087471
A087470
A080237
A087682
A087701
A080334
A080506
A085084
A087773
A086813
A086867
A087772
A088465
A084913
A080343
A089028
A084913

001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
002
003
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001
001
001
001
001
001
001
002

5MG

A080223

001

1%
2%
3%

N014763
N014763
N014763

004
005
003

4%

N014763

007

250MG/5ML

N010401

001

PRILOCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
CITANEST
ASTRAZENECA

CITANEST PLAIN
ASTRAZENECA

PRIMIDONE
SUSPENSION; ORAL
MYSOLINE
NURO PHARMA

May 04, 1982

Jan 12, 1989

Jan 12, 1989

Oct 25, 1984

Oct 25, 1984
Oct 25, 1984
Jan 18, 1983
Jan 18, 1983
Jan 18, 1983

Jan 15, 1982

Jan 15, 1982

Jul 13, 1982

Jul 13, 1982

Jun 01, 1984

Jul 24, 1986

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6 - 278 (of 346)

PRIMIDONE
TABLET; ORAL
PRIMIDONE
WATSON LABS

250MG

A085052

001

500MG

N007898

004

500MG
500MG

A086917
A086150

001
002

Apr 23, 1982

250MG
500MG

N017535
N017535

001
002

Jul 06, 1988

A087542
A087697
A087543
A084604
A084595
A084606
A083693
A084696
A086942
A086952
A086943
A088989
A088990
A089219
A089220
A089221
A087643
A087875
A083287
A083795
A085167
A084403
A087020
A084280
A084357
A087021

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

A085804
A087502
A085079

001
001
001

A083553

002

N007335
N007335
N007335

001
004
003

A089415
A089416
A089029

001
001
001

PROBENECID
TABLET; ORAL
BENEMID
MERCK
PROBENECID
LEDERLE
WATSON LABS

PROBUCOL
TABLET; ORAL
LORELCO
SANOFI AVENTIS US

PROCAINAMIDE HYDROCHLORIDE
CAPSULE; ORAL
PROCAINAMIDE HYDROCHLORIDE
ASCOT
250MG
375MG
500MG
IVAX SUB TEVA PHARMS 250MG
375MG
500MG
LANNETT
250MG
500MG
LEDERLE
250MG
375MG
500MG
ROXANE
250MG
500MG
SANDOZ
250MG
375MG
500MG
VANGARD
250MG
500MG
WATSON LABS
250MG
250MG
250MG
375MG
375MG
500MG
500MG
500MG
PROCAN
PARKE DAVIS
250MG
375MG
500MG
PROCAPAN
PANRAY
250MG
PRONESTYL
APOTHECON
250MG
375MG
500MG
INJECTABLE; INJECTION
PROCAINAMIDE HYDROCHLORIDE
ABRAXIS PHARM
100MG/ML
500MG/ML
BAXTER HLTHCARE
100MG/ML

Jan 08, 1982

Mar 01, 1983
Jan 08, 1982

Apr
Apr
Jul
Jul
Jul
Jun
Jun

26,
26,
01,
01,
01,
01,
01,

1985
1985
1986
1986
1986
1982
1982

Nov 17, 1986

Nov 17, 1986
Apr 17, 1986

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 279 (of 346)

PROCAINAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION

PROCAINAMIDE HYDROCHLORIDE

BAXTER HLTHCARE
500MG/ML
HOSPIRA
500MG/ML
PHARMAFAIR
100MG/ML
500MG/ML
SMITH AND NEPHEW
100MG/ML
500MG/ML
SOLOPAK
500MG/ML
WARNER CHILCOTT
100MG/ML
500MG/ML
WATSON LABS
100MG/ML
500MG/ML
PRONESTYL
APOTHECON
100MG/ML
500MG/ML
TABLET; ORAL
PRONESTYL
APOTHECON
250MG
375MG
500MG
TABLET, EXTENDED RELEASE; ORAL

PROCAINAMIDE HYDROCHLORIDE

COPLEY PHARM
500MG
750MG
1GM
INWOOD LABS
500MG
PLIVA
250MG
500MG
SANDOZ
250MG
500MG
500MG
750MG
WATSON LABS
250MG
250MG
500MG
500MG
750MG
750MG
1GM
PROCAN SR

PARKE DAVIS
250MG
PARKEDALE
500MG
750MG
1GM
PROCANBID
KING PHARMS
500MG
1GM
PRONESTYL-SR
APOTHECON
500MG

A089030
A089537
A088824
A088830
A088530
A088531
A088532
A089528
A089529
A087079
A087080

001
001
001
001
001
001
001
001
001
001
001

Apr
Aug
Nov
Nov
Mar
Mar
Mar
May
May

17,
25,
20,
20,
04,
04,
04,
03,
03,

1986
1987
1985
1985
1985
1985
1985
1988
1988

N007335
N007335

002
005

N017371
N017371
N017371

001

002

003

A088974
A089438
A040111
A089840
A088958
A088959
A089369
A089284
A089370
A089371
A088533
A089026
A088534
A089027
A088535
A089042
A089520

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jul
Mar
Dec
Mar
Dec
Dec
Aug
Jun
Jan
Aug
Dec
Oct
Dec
Oct
Nov
Oct
Jan

22,
23,
13,
06,
02,
02,
14,
23,
09,
14,
03,
22,
03,
22,
03,
22,
15,

1985
1987
1996
1989
1985
1985
1987
1986
1987
1987
1984
1985
1984
1985
1984
1985
1987

A086468
A086065
A087510
A088489

001

001

001
001

Apr 01, 1982

Jan 16, 1985

N020545
N020545

001
002

Jan 31, 1996

Jan 31, 1996

A087361

001

1%
2%
10%

A085362
A085362
A086797

003
004
001

1%
1%
2%
2%

A080384
A080421
A080384
A080421

002
001
003
002

PROCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
NOVOCAIN
HOSPIRA

PROCAINE HYDROCHLORIDE
ABRAXIS PHARM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 280 (of 346)

PROCAINE HYDROCHLORIDE
INJECTABLE; INJECTION
PROCAINE HYDROCHLORIDE
BEL MAR
ELKINS SINN
GD SEARLE LLC
HOSPIRA
MILES
WATSON LABS

1%
2%
1%
2%
1%
2%
1%
2%
1%
2%
1%
1%
2%
2%

A080711
A080756
A083315
A083315
A086202
A086202
A080416
A080416
A080415
A080415
A080658
A083535
A080658
A083535

001
001
001
002
001
002
001
002
001
002
001
001
002
002

40MG/VIAL;100MG/VIAL
40MG/VIAL;250MG/VIAL

N050276
N050276

001
003

40MG/VIAL;100MG/VIAL
40MG/VIAL;250MG/VIAL

A060285
A060285

002
003

100MG/ML;50MG/ML

N008869

001

2.5MG
5MG
25MG

N011127
N011127
N011127

003
001
002

2.5MG
5MG
25MG

A040407
A040407
A040407

001
002
003

10MG BASE/ML

N011276

001

10MG BASE/ML

A087153

001

Jun 08, 1982

10MG BASE/ML

A088598

001

Oct 25, 1984

5MG BASE/ML

N010742

002

5MG BASE/ML

A087759

001

Oct 01, 1982

5MG
5MG
5MG
5MG
5MG
5MG

A089523
A089703
A089675
A089251
A040505
A089530

001
001
001
001
001
001

May
Apr
Dec
Dec
May
Jul

PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE

INJECTABLE; INJECTION
ACHROMYCIN
LEDERLE
TETRACYN
PFIZER

PROCAINE MERETHOXYLLINE; THEOPHYLLINE

INJECTABLE; INJECTION
DICURIN PROCAINE
LILLY

PROCHLORPERAZINE
SUPPOSITORY; RECTAL
COMPAZINE
GLAXOSMITHKLINE

PROCHLORPERAZINE
ABLE

Jul 11, 2001

Jul 11, 2001
Jul 11, 2001

PROCHLORPERAZINE EDISYLATE
CONCENTRATE; ORAL
COMPAZINE
GLAXOSMITHKLINE
EQ
PROCHLORPERAZINE
ALPHARMA US PHARMS
EQ
PROCHLORPERAZINE EDISYLATE
MORTON GROVE
EQ
INJECTABLE; INJECTION
COMPAZINE
GLAXOSMITHKLINE
EQ
PROCHLORPERAZINE
BAXTER HLTHCARE
EQ
PROCHLORPERAZINE EDISYLATE
BAXTER HLTHCARE
EQ
HOSPIRA
EQ
MARSAM PHARMS LLC
EQ
SMITH AND NEPHEW
EQ
TEVA PARENTERAL
EQ
WATSON LABS
EQ

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

03,
07,
05,
04,
30,
08,

1988
1988
1988
1986
2003
1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 281 (of 346)

PROCHLORPERAZINE EDISYLATE
INJECTABLE; INJECTION
PROCHLORPERAZINE EDISYLATE
WATSON LABS
EQ
EQ
WYETH AYERST
EQ
SYRUP; ORAL
COMPAZINE
GLAXOSMITHKLINE
EQ
PROCHLORPERAZINE EDISYLATE
ALPHARMA US PHARMS
EQ
MORTON GROVE
EQ

5MG BASE/ML
5MG BASE/ML
5MG BASE/ML

A089605
A089606
A086348

001
001
001

5MG BASE/5ML

N011188

001

5MG BASE/5ML
5MG BASE/5ML

A087154
A088597

001
001

N011000
N021019
N011000
N021019
N011000
N011000

001
001
002
002
003
004

N010571
N010571
N010571

001
002
003

A085580
A085178
A085579

001
001
001

A040207
A089484
A040207
A089485
A089486
A040162
A040162
A040101

001
001
002
001
001
001
002
003

2MG
5MG

N009818
N009818

005
003

300MG

N019781

003

N009238
N009238

002
001

N017553

001

N010942
N010942

001
004

Jul 08, 1987

Jul 08, 1987

Sep 01, 1982

Oct 25, 1984

PROCHLORPERAZINE MALEATE
CAPSULE, EXTENDED RELEASE; ORAL
COMPAZINE
GLAXOSMITHKLINE
EQ 10MG BASE
EQ 10MG BASE
EQ 15MG BASE
EQ 15MG BASE
EQ 30MG BASE
EQ 75MG BASE
TABLET; ORAL
COMPAZINE
GLAXOSMITHKLINE
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
PROCHLORPERAZINE
WATSON LABS
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
PROCHLORPERAZINE MALEATE
DURAMED PHARMS BARR
EQ 5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 25MG BASE
IVAX SUB TEVA PHARMS EQ 5MG BASE
EQ 10MG BASE
SANDOZ
EQ 25MG BASE

Oct 06, 1999

Oct 06, 1999

May
Jan
May
Jan
Jan
Jan
Jan
Jul

01,
20,
01,
20,
20,
20,
20,
19,

1997
1987
1997
1987
1987
1998
1998
1996

PROCYCLIDINE HYDROCHLORIDE
TABLET; ORAL
KEMADRIN
MONARCH PHARMS

PROGESTERONE
CAPSULE; ORAL
PROMETRIUM
ABBOTT LABS
INJECTABLE; INJECTION
PROGESTERONE
LILLY

25MG/ML
50MG/ML
INSERT, EXTENDED RELEASE; INTRAUTERINE
PROGESTASERT
ALZA
38MG

PROMAZINE HYDROCHLORIDE
CONCENTRATE; ORAL
SPARINE
WYETH AYERST

30MG/ML
100MG/ML

Oct 15, 1999

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 282 (of 346)

PROMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
PROMAZINE HYDROCHLORIDE
WATSON LABS
25MG/ML
50MG/ML
SPARINE
BAXTER HLTHCARE CORP 25MG/ML
50MG/ML
SYRUP; ORAL
SPARINE
WYETH AYERST
10MG/5ML
TABLET; ORAL
SPARINE
WYETH AYERST
10MG
25MG
50MG
100MG
200MG

A084510
A084517

001
001

N010349
N010349

008
006

N010942

003

N010348
N010348
N010348
N010348
N010348

006
001
002
003
004

N008857
N008857

002
003

A084223
A084222
A083955
A083955
A040524
A040524
A040471
A040372
A083838
A089463
A089477
A040593
A040593
A083532
A084591
A080629
A083532

001
001
002
001
001
002
001
002
002
001
001
001
002
001
001
002
002

A083997

001

A083997

002

N010926
N010926
N011689

002
001
001

A084901
A084902

001
001

A040504
A040504
A040449

001
002
001

Apr 11, 2003

Apr 11, 2003
Feb 27, 2003

A087996

001

Jan 18, 1983

A084772

001

PROMETHAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
PHENERGAN
WYETH AYERST

25MG/ML
50MG/ML
PROMETHAZINE HYDROCHLORIDE
ABBOTT
25MG/ML
50MG/ML
AKORN
25MG/ML
50MG/ML
BEDFORD LABS
25MG/ML
50MG/ML
BIONICHE PHARMA
25MG/ML
HOSPIRA
50MG/ML
50MG/ML
MARSAM PHARMS LLC
25MG/ML
50MG/ML
SANDOZ
25MG/ML
50MG/ML
WATSON LABS
25MG/ML
25MG/ML
50MG/ML
50MG/ML
ZIPAN-25
ALTANA
25MG/ML
ZIPAN-50
ALTANA
50MG/ML
SUPPOSITORY; RECTAL
PHENERGAN
SHIONOGI INC
12.5MG
25MG
50MG
PROMETHACON
POLYMEDICA
25MG
50MG
PROMETHAZINE HYDROCHLORIDE
ABLE
12.5MG
25MG
50MG
SYRUP; ORAL
MYMETHAZINE FORTIS
USL PHARMA
25MG/5ML
PROMETH FORTIS
ALPHARMA US PHARMS
25MG/5ML

Mar
Mar
Nov
Jun

17,
17,
21,
08,

2004
2004
2002
2000

May
May
Nov
Nov

02,
02,
08,
08,

1988
1988
2006
2006

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 283 (of 346)

PROMETHAZINE HYDROCHLORIDE
SYRUP; ORAL
PROMETH PLAIN
ACTAVIS MID ATLANTIC 6.25MG/5ML
PROMETHAZINE
CENCI
6.25MG/5ML
PROMETHAZINE HYDROCHLORIDE
KV PHARM
6.25MG/5ML
25MG/5ML
PHARM ASSOC
6.25MG/5ML
WHITEWORTH TOWN PLSN 6.25MG/5ML
PROMETHAZINE HYDROCHLORIDE PLAIN
ANI PHARMS
6.25MG/5ML
25MG/5ML
TABLET; ORAL
PHENERGAN
WYETH PHARMS INC
12.5MG
25MG
50MG
PROMETHAZINE HYDROCHLORIDE
ABBOTT
12.5MG
25MG
50MG
ABLE
12.5MG
25MG
50MG
IMPAX LABS
25MG
IVAX SUB TEVA PHARMS 12.5MG
25MG
50MG
LANNETT
12.5MG
25MG
50MG
MUTUAL PHARM
12.5MG
25MG
50MG
PVT FORM
12.5MG
25MG
SANDOZ
12.5MG
12.5MG
25MG
50MG
TABLICAPS
12.5MG
25MG
TEVA
25MG
WATSON LABS
12.5MG
12.5MG
12.5MG
25MG
25MG
50MG
50MG
REMSED
BRISTOL MYERS SQUIBB 25MG
50MG

A085953

001

A089013

001

A085388
A085385
A087518
A086395

001
001
001
001

N008381
N008381

004
003

N007935
N007935
N007935

002
003
004

A084160
A084166
A084539
A040558
A040558
A040558
A084214
A083604
A083603
A083613
A080949
A080949
A080949
A084555
A084554
A084557
A083214
A083658
A084176
A084233
A085146
A085146
A084080
A084027
A089109
A083401
A083712
A085986
A083204
A085684
A083403
A085664

001
001
001
001
002
003
002
001
001
001
001
002
003
001
001
001
001
001
002
001
001
002
001
001
001
001
001
001
001
001
001
001

A083176
A083176

002
001

30MG/VIAL

N008843

001

7.5MG

N008732

003

PROPANTHELINE BROMIDE
INJECTABLE; INJECTION
PRO-BANTHINE
GD SEARLE LLC
TABLET; ORAL
PRO-BANTHINE
SHIRE

Sep 20, 1985

Apr 18, 1984

Jul
Jul
Jul
Jul

01,
01,
01,
07,

2004
2004
2004
1982

May 22, 2009

Sep 10, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 284 (of 346)

PROPANTHELINE BROMIDE
TABLET; ORAL
PRO-BANTHINE
SHIRE
PROPANTHELINE BROMIDE
ASCOT
HEATHER
IMPAX LABS
MYLAN
PAR PHARM
PVT FORM
ROXANE
SANDOZ
TABLICAPS
WATSON LABS

15MG

N008732

002

15MG
15MG
15MG
15MG
15MG
15MG
7.5MG
15MG
15MG
15MG
15MG

A087663
A085780
A084541
A083706
A088377
A080977
A080927
A080928
A084428
A083029
A083151

001
001
002
001
001
001
001
001
001
002
001

Oct 25, 1982

A088087

001

Jun 07, 1983

A087681

001

Aug 05, 1982

A084144
A084151

001
001

N011657

001

20MG/ML

N012382

002

10MG/ML

N019627

001

Oct 02, 1989

10MG/ML
10MG/ML

A074848
A075392

001
001

Apr 19, 2005

Sep 19, 2000

N010997
N010997

001
003

A080530

001

A083544

001

A083538

002

A083184
A083317
A083597
A083186
A083528
A040569

001
001
001
001
001
001

Dec 08, 1983

PROPARACAINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
KAINAIR
PHARMAFAIR
0.5%
PARACAINE
OPTOPICS
0.5%
PROPARACAINE HYDROCHLORIDE
SOLA BARNES HIND
0.5%
0.5%

PROPIOLACTONE
SOLUTION; IRRIGATION
BETAPRONE
FOREST LABS

N/A

PROPIOMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
LARGON
BAXTER HLTHCARE CORP

PROPOFOL
INJECTABLE; INJECTION
DIPRIVAN
APP PHARMS
PROPOFOL
BEDFORD
TEVA PARENTERAL

PROPOXYPHENE HYDROCHLORIDE
CAPSULE; ORAL
DARVON
XANODYNE PHARM

32MG
65MG

DOLENE
HERITAGE PHARMS INC
65MG
KESSO-GESIC
MK LABS
65MG
PROPHENE 65
HALSEY
65MG
PROPOXYPHENE HYDROCHLORIDE
ALRA
65MG
IMPAX LABS
65MG
IVAX SUB TEVA PHARMS 32MG
MUTUAL PHARM
65MG
MYLAN
32MG
65MG

Dec 16, 2004

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 285 (of 346)

PROPOXYPHENE HYDROCHLORIDE
CAPSULE; ORAL
PROPOXYPHENE HYDROCHLORIDE
MYLAN
65MG
NEXGEN PHARMA INC
65MG
PAR PHARM
65MG
PUREPAC PHARM
65MG
PVT FORM
32MG
65MG
ROXANE
32MG
65MG
SANDOZ
32MG
65MG
65MG
65MG
65MG
TEVA
65MG
VALEANT PHARM INTL
65MG
VINTAGE PHARMS
65MG
WATSON LABS
65MG
65MG
WEST WARD
65MG
WHITEWORTH TOWN PLSN 65MG
PROPOXYPHENE HYDROCHLORIDE 65
WARNER CHILCOTT
65MG

A083299
A083185
A080269
A083278
A083464
A083113
A083089
A083089
A084014
A083125
A083688
A083870
A086495
A088615
A080783
A040908
A080908
A085190
A083501
A084551

001
001
001
001
001
001
001
002
001
002
001
002
001
001
001
001
002
001
001
001

A083786

001

50MG/5ML

N016861

001

100MG

N016862

002

A072499
A072500
A072501
A072502

001
001
001
001

Apr
Apr
Apr
Apr

A071388

001

May 15, 1987

A070135
A070137
A070136

001
001
001

Apr 15, 1986

Apr 15, 1986
Apr 15, 1986

A071984
A071985

001
001

Mar 03, 1989

Mar 03, 1989

N019536

001

Dec 12, 1986

N016418
N016418
N016418

001
003
010

Oct 18, 1982

A070125
A070126

001
001

Jul 30, 1985

Jul 30, 1985

Oct 22, 1984

Jul 17, 2009

PROPOXYPHENE NAPSYLATE
SUSPENSION; ORAL
DARVON-N
AAIPHARMA LLC
TABLET; ORAL
DARVON-N
XANODYNE PHARM

PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
PROPRANOLOL HYDROCHLORIDE
INWOOD LABS
60MG
80MG
120MG
160MG
CONCENTRATE; ORAL
PROPRANOLOL HYDROCHLORIDE INTENSOL
ROXANE
80MG/ML
INJECTABLE; INJECTION
PROPRANOLOL HYDROCHLORIDE
SMITH AND NEPHEW
1MG/ML
1MG/ML
SOLOPAK
1MG/ML
SOLUTION; ORAL
PROPRANOLOL HYDROCHLORIDE
MORTON GROVE
20MG/5ML
40MG/5ML
SUSPENSION; ORAL
INDERAL
WYETH AYERST
10MG/ML
TABLET; ORAL
INDERAL
AKRIMAX PHARMS
10MG
20MG
90MG
PROPRANOLOL HYDROCHLORIDE
CLONMEL HLTHCARE
10MG
20MG

11,
11,
11,
11,

1989
1989
1989
1989

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DISCONTINUED DRUG PRODUCT LIST

6 - 286 (of 346)

PROPRANOLOL HYDROCHLORIDE
TABLET; ORAL
PROPRANOLOL HYDROCHLORIDE
CLONMEL HLTHCARE
40MG
60MG
80MG
90MG
DURAMED PHARMS BARR
10MG
20MG
40MG
60MG
80MG
90MG
INTERPHARM
10MG
20MG
40MG
80MG
IVAX SUB TEVA PHARMS 10MG
20MG
40MG
60MG
80MG
LEDERLE
10MG
20MG
40MG
80MG
MUTUAL PHARM
10MG
20MG
40MG
60MG
80MG
MYLAN
60MG
PAR PHARM
90MG
PLIVA
90MG
PUREPAC PHARM
10MG
20MG
40MG
60MG
80MG
ROXANE
10MG
20MG
40MG
60MG
80MG
90MG
SANDOZ
10MG
10MG
20MG
20MG
40MG
40MG
60MG
60MG
80MG
80MG
90MG
SCHERING
10MG
20MG
40MG
60MG
80MG
SUPERPHARM
10MG
20MG

A070127
A071495
A070128
A071496
A070306
A070307
A070308
A070309
A070310
A071327
A071368
A071369
A071370
A071371
A072063
A072066
A072067
A072068
A072069
A072117
A072118
A072119
A072120
A070319
A070320
A070103
A070321
A070322
A072275
A071288
A071977
A070814
A070815
A070816
A070817
A070757
A070516
A070517
A070518
A070519
A070520
A070521
A070663
A071658
A070664
A071687
A070665
A071688
A070666
A072197
A070667
A071689
A072198
A070120
A070121
A070122
A070123
A070124
A071515
A071516

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jul
Dec
Jul
Dec
Sep
Sep
Sep
Oct
Sep
Oct
May
May
May
May
Jul
Jul
Jul
Jul
Jul
Jun
Jun
Jun
Jun
Oct
Oct
Oct
Sep
Aug
Jun
Oct
Apr
Nov
Nov
Nov
Nov
Nov
Jul
Jul
Jul
Sep
Jul
Sep
Jun
Jul
Jun
Jul
Jun
Jul
Oct
Jul
Jun
Jul
Jul
Aug
Aug
Aug
Oct
Aug
Jun
Jun

30,
31,
30,
31,
09,
09,
09,
01,
09,
01,
05,
05,
05,
05,
29,
29,
29,
29,
29,
23,
23,
23,
23,
22,
22,
22,
24,
04,
09,
22,
06,
03,
03,
03,
03,
03,
07,
07,
07,
24,
07,
24,
13,
05,
13,
05,
13,
05,
10,
05,
13,
05,
05,
06,
06,
06,
29,
06,
08,
08,

1985
1987
1985
1987
1985
1985
1985
1986
1985
1986
1987
1987
1987
1987
1988
1988
1988
1988
1988
1988
1988
1988
1988
1985
1985
1985
1986
1986
1989
1986
1988
1986
1986
1986
1986
1986
1986
1986
1986
1986
1986
1986
1986
1988
1986
1988
1986
1988
1986
1988
1986
1988
1988
1985
1985
1985
1986
1985
1988
1988

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DISCONTINUED DRUG PRODUCT LIST

6 - 287 (of 346)

PROPRANOLOL HYDROCHLORIDE
TABLET; ORAL
PROPRANOLOL HYDROCHLORIDE
SUPERPHARM
40MG
80MG
TEVA
10MG
20MG
40MG
WARNER CHILCOTT
10MG
20MG
40MG
60MG
80MG
WATSON LABS
10MG
10MG
10MG
20MG
20MG
20MG
40MG
40MG
40MG
60MG
60MG
60MG
60MG
80MG
80MG
80MG
90MG
90MG

A071517
A071518
A070232
A070233
A070234
A070438
A070439
A070440
A070441
A070442
A070140
A070378
A070548
A070141
A070379
A070549
A070142
A070380
A070550
A070143
A070381
A071098
A071791
A070144
A070382
A070551
A071183
A071792

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

N009309

001

N009309

002

50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG
50MG

A084075
A080285
A080015
A080159
A080215
A080016
N006213
A083982
A084543
A080840
A080932
A085201

001
001
001
001
001
001
001
001
001
001
001
001

10MG/ML
10MG/ML
10MG/ML
50MG/VIAL
250MG/VIAL

A089474
A089475
N006460
N007413
N007413

001
001
002
001
002

Jun
Jun
Oct
Jun
Jun
Sep
Sep
Sep
Sep
Sep
Jul
Mar
Jul
Jul
Mar
Apr
Jul
Mar
Apr
Jan
Mar
Oct
Jul
Jul
Mar
Jul
Oct
Jul

08,
08,
07,
23,
23,
15,
15,
15,
24,
15,
30,
19,
10,
30,
19,
11,
30,
19,
11,
15,
19,
06,
15,
30,
19,
10,
06,
15,

1988
1988
1987
1986
1986
1986
1986
1986
1986
1986
1985
1987
1986
1985
1987
1986
1985
1987
1986
1987
1987
1986
1987
1985
1987
1986
1986
1987

PROPYLIODONE
SUSPENSION; INTRATRACHEAL
DIONOSIL AQUEOUS
GLAXOSMITHKLINE
50%
DIONOSIL OILY
GLAXOSMITHKLINE
60%

PROPYLTHIOURACIL
TABLET; ORAL
PROPYLTHIOURACIL
ABBOTT
ANABOLIC
HALSEY
IMPAX LABS
IVAX SUB TEVA PHARMS
LANNETT
LILLY
MUTUAL PHARM
PERRIGO
TABLICAPS
WATSON LABS

PROTAMINE SULFATE
INJECTABLE; INJECTION
PROTAMINE SULFATE
BAXTER HLTHCARE
LILLY
PHARMACIA AND UPJOHN

Nov 05, 1986

Nov 05, 1986

Aug 02, 1984

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6 - 288 (of 346)

PROTEIN HYDROLYSATE
INJECTABLE; INJECTION
AMINOSOL 5%
ABBOTT
HYPROTIGEN 5%
B BRAUN

5%

N005932

012

Jan 31, 1985

5%

N006170

003

Jan 10, 1984

0.5MG/ML

N017638

001

0.5MG/ML

N018087

001

2MG

A083459

001

N016012
N016012

001
002

N017603

001

N017941

002

N018996

001

Jun 17, 1985

A071798

001

Mar 16, 1989

A088344

001

Feb 09, 1984

A088283

001

Apr 20, 1984

A088116

001

Mar 04, 1983

A088474

001

Feb 12, 1985

A088860

001

Jan 31, 1985

A088602

001

Apr 11, 1985

A088193

001

May 17, 1983

A088515

001

Jan 09, 1985

A088630

001

May 17, 1984

A088318
A088117

002
001

Jan 13, 1984

Apr 19, 1983

A085273

001

Dec 12, 1984

PROTIRELIN
INJECTABLE; INJECTION
THYPINONE
ABBOTT
THYREL TRH
FERRING

PROTOKYLOL HYDROCHLORIDE
TABLET; ORAL
VENTAIRE
SANOFI AVENTIS US

PROTRIPTYLINE HYDROCHLORIDE
TABLET; ORAL
VIVACTIL
ODYSSEY PHARMS

5MG
10MG

PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
NOVAFED
SANOFI AVENTIS US
120MG
SUDAFED 12 HOUR
GLAXOSMITHKLINE
120MG

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE; ORAL
ACTIFED
GLAXOSMITHKLINE
120MG;5MG
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES
KV PHARM
120MG;5MG
SYRUP; ORAL
ACTAHIST
CENCI
30MG/5ML;1.25MG/5ML
HISTAFED
CENCI
30MG/5ML;1.25MG/5ML
MYFED
USL PHARMA
30MG/5ML;1.25MG/5ML
TRILITRON
NEWTRON PHARMS
30MG/5ML;1.25MG/5ML
TABLET; ORAL
ALLERFED
PVT FORM
60MG;2.5MG
CORPHED
SANDOZ
60MG;2.5MG
PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE
SANDOZ
60MG;2.5MG
TRILITRON
NEWTRON PHARMS
60MG;2.5MG
TRIPHED
TEVA
60MG;2.5MG
TRIPROLIDINE AND PSEUDOEPHEDRINE
WATSON LABS
60MG;2.5MG
WEST WARD
60MG;2.5MG
TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 60MG;2.5MG

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6 - 289 (of 346)

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

TABLET; ORAL
TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
SUPERPHARM
60MG;2.5MG
TABLET, EXTENDED RELEASE; ORAL
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES
KV PHARM
120MG;5MG

A088578

001

Feb 21, 1985

A072758

001

Nov 25, 1991

N019401

001

Jun 19, 1987

A040512
A040512
A089572
N020414

002
001
001
001

Jul
Oct
Nov
Feb

A080854

001

A087967
A080761
A083771
A083772
A080581
A080669
A080572
A083760

001
001
001
001
001
001
001
001

A080808
A085231

001
001

N018557

001

N019412

002

EQ 50MG BASE/5ML

N011964

001

EQ 50MG BASE

N012485

002

7.5MG

N018708

003

PSEUDOEPHEDRINE POLISTIREX
SUSPENSION, EXTENDED RELEASE; ORAL
PSEUDO-12
UCB INC
EQ 60MG HCL/5ML

PYRIDOSTIGMINE BROMIDE
TABLET; ORAL
PYRIDOSTIGMINE BROMIDE
BARR
SOLVAY
US ARMY

30MG
60MG
30MG
30MG

20,
08,
27,
05,

2005
2003
1990
2003

PYRIDOXINE HYDROCHLORIDE
INJECTABLE; INJECTION
HEXA-BETALIN
LILLY
100MG/ML
PYRIDOXINE HYDROCHLORIDE
AKORN
100MG/ML
BEL MAR
100MG/ML
DELL LABS
50MG/ML
100MG/ML
ELKINS SINN
100MG/ML
LUITPOLD
100MG/ML
WATSON LABS
100MG/ML
100MG/ML

Oct 01, 1982

PYRILAMINE MALEATE
TABLET; ORAL
PYRILAMINE MALEATE
IMPAX LABS
WATSON LABS

25MG
25MG

PYRIMETHAMINE; SULFADOXINE
TABLET; ORAL
FANSIDAR
ROCHE

25MG;500MG

PYRITHIONE ZINC
LOTION; TOPICAL
HEAD & SHOULDERS CONDITIONER
WARNER CHILCOTT
0.3%

Mar 10, 1986

PYRVINIUM PAMOATE
SUSPENSION; ORAL
POVAN
PARKE DAVIS
TABLET; ORAL
POVAN
PARKE DAVIS

QUAZEPAM
TABLET; ORAL
DORAL
QUESTCOR PHARMS

Feb 26, 1987

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6 - 290 (of 346)

QUETIAPINE FUMARATE
TABLET; ORAL
SEROQUEL
ASTRAZENECA

EQ 150MG BASE

N020639

004

Dec 20, 1998

A076459
A076459
A076459
A076459

001
002
003
004

Dec
Dec
Dec
Dec

0.1MG
0.2MG

N016768
N016768

002
003

50MG

N013264

001

50MG;0.125MG

N013927

001

A085978
A086099

001
001

N017917

001

N016647

001

A088081

001

A087448

001

A088582
A089476
A088431
A089894
A089164
A087785

001
001
001
001
001
001

275MG

N011642

002

200MG
300MG

A085296
A085297

001
001

200MG

A085103

001

QUINAPRIL HYDROCHLORIDE
TABLET; ORAL
QUINAPRIL HYDROCHLORIDE
ACTAVIS TOTOWA
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
20MG BASE
40MG BASE

22,
22,
22,
22,

2004
2004
2004
2004

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

266MG
400MG
TABLET, EXTENDED RELEASE; ORAL
DURAQUIN
WARNER CHILCOTT
330MG
QUINAGLUTE
BAYER HLTHCARE
324MG
QUINALAN
LANNETT
324MG
QUINATIME
WATSON LABS
324MG
QUINIDINE GLUCONATE
ASCOT
324MG
HALSEY
324MG
ROXANE
324MG
SANDOZ
324MG
SUPERPHARM
324MG
WATSON LABS
324MG

QUINIDINE POLYGALACTURONATE
TABLET; ORAL
CARDIOQUIN
PHARM RES ASSOC

QUINIDINE SULFATE
CAPSULE; ORAL
CIN-QUIN
SOLVAY
QUINIDINE SULFATE
LILLY

Feb 10, 1986

Jun
Apr
Jan
Dec
Nov
Jan

17,
10,
06,
15,
21,
24,

1985
1987
1984
1988
1985
1983

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6 - 291 (of 346)

QUINIDINE SULFATE
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
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;
QUINIDEX
WYETH PHARMS INC

100MG
200MG
300MG

A085299
A084932
A085298

001
001
001

200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
100MG
200MG
200MG
200MG
200MG
300MG
200MG
200MG
300MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
100MG
200MG
200MG
200MG

A084177
A087011
A083808
A083622
A083439
A083583
A083347
A084549
A085175
A085276
A083743
A086176
A085038
A081029
A085322
A084627
A084003
A083640
A085632
A084631
A084914
A089839
A085068
A088973
A087837
A083393
A087909
A083963
A083879
A085584
A085140
A083862
A085444

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
002
001
001

200MG
300MG
ORAL

A083576
A085222

001
001

300MG

N012796

002

N020973

001

May 29, 2002

A077513
A077513
A077513
A077513

001
002
003
004

Jun
Jun
Jun
Jun

Apr 14, 1989

Sep 29, 1988

Apr 10, 1985
Apr 14, 1982
Jul 13, 1982

RABEPRAZOLE SODIUM
TABLET, DELAYED RELEASE; ORAL
ACIPHEX
EISAI INC
10MG

RAMIPRIL
CAPSULE; ORAL
RAMIPRIL
ACTAVIS ELIZABETH

1.25MG
2.5MG
5MG
10MG

18,
18,
18,
18,

2008
2008
2008
2008

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DISCONTINUED DRUG PRODUCT LIST

6 - 292 (of 346)

RANITIDINE BISMUTH CITRATE

TABLET; ORAL
TRITEC
GLAXOSMITHKLINE

400MG

N020559

001

Aug 08, 1996

A075564
A075564
A075557
A075557

001
002
001
002

Oct
Oct
Oct
Oct

N020095

001

Mar 08, 1994

N020095

002

Mar 08, 1994

N020251

002

Mar 31, 1994

A074764

001

Nov 19, 2004

N019593

001

Dec 17, 1986

A074662
A074662
A074552
A074552
A075132
A075254
A075000
A075439
A075000
A075439
A075519

001
002
001
002
001
001
001
001
002
002
001

Aug
Aug
Jul
Jul
Jan
Jan
Jan
Apr
Jan
Apr
Sep

N020251

001

Mar 31, 1994

N020745

001

Feb 26, 1998

100MG/VIAL
200MG/VIAL

N020984
N020984

001
002

Aug 18, 1999

Aug 18, 1999

50MG
50MG
100MG

N009276
N009276
N009276

003
005
004

50MG

N010581

001

50MG
100MG

N009278
N009278

001
002

50MG
100MG

N008842
N008842

001
002

RANITIDINE HYDROCHLORIDE
CAPSULE; ORAL
RANITIDINE HYDROCHLORIDE
MYLAN
EQ 150MG BASE
EQ 300MG BASE
TEVA
EQ 150MG BASE
EQ 300MG BASE
ZANTAC 150
GLAXOSMITHKLINE
EQ 150MG BASE
ZANTAC 300
GLAXOSMITHKLINE
EQ 300MG BASE
GRANULE, EFFERVESCENT; ORAL
ZANTAC 150
GLAXOSMITHKLINE
EQ 150MG BASE/PACKET
INJECTABLE; INJECTION
RANITIDINE HYDROCHLORIDE
BEDFORD
EQ 25MG BASE/ML
ZANTAC IN PLASTIC CONTAINER
GLAXOSMITHKLINE
EQ 50MG BASE/100ML
TABLET; ORAL
RANITIDINE HYDROCHLORIDE
BOEHRINGER INGELHEIM EQ 150MG BASE
EQ 300MG BASE
MYLAN
EQ 150MG BASE
EQ 300MG BASE
RANBAXY
EQ 75MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 300MG BASE
SANDOZ
EQ 75MG BASE
TABLET, EFFERVESCENT; ORAL
ZANTAC 150
GLAXOSMITHKLINE
EQ 150MG BASE
ZANTAC 75
BOEHRINGER INGELHEIM EQ 75MG BASE

27,
27,
31,
31,

29,
29,
30,
30,
14,
14,
30,
19,
30,
19,
26,

2000
2000
2003
2003

1997
1997
1998
1998
2000
2000
1998
2000
1998
2000
2002

RAPACURONIUM BROMIDE
INJECTABLE; INJECTION
RAPLON
ORGANON USA INC

RAUWOLFIA SERPENTINA ROOT

TABLET; ORAL
HIWOLFIA
BOWMAN PHARMS

HYSERPIN
PHYS PRODS VA
KOGLUCOID
PANRAY
RAUDIXIN
APOTHECON

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6 - 293 (of 346)

RAUWOLFIA SERPENTINA ROOT

TABLET; ORAL
RAUSERPIN
FERNDALE LABS
RAUVAL
PAL PAK
RAUWOLFIA SERPENTINA
BUNDY
HALSEY
IMPAX LABS
IVAX SUB TEVA PHARMS
PUREPAC PHARM
PVT FORM
SOLVAY
TABLICAPS
VALEANT PHARM INTL
WATSON LABS
WOLFINA
FOREST PHARMS

50MG
100MG

N009926
N009926

002
004

50MG
100MG

N009108
N009108

002
004

50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG
50MG
100MG

N009477
N009477
A080498
A080498
N009273
N009273
N011521
N011521
A080842
A080842
A080583
A080583
A080500
A080500
A083867
A083444
N009668
N009668
A080907
A080914

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
001
001
002
001
001

50MG
100MG

N009255
N009255

008
006

0.5MG

A084736

001

0.25MG
0.5MG

N010686
N010686

003
006

0.2MG/4ML

N009115

005

2.5MG/ML

N010012

001

2.5MG/ML

N009434

002

0.1MG
0.25MG

N009631
N009631

002
004

0.1MG
0.25MG
0.5MG
1MG

N009357
N009357
N009357
N009357

001
004
006
008

0.25MG
0.1MG
0.25MG

A080721
A083058
A083058

002
001
002

RESCINNAMINE
CAPSULE; ORAL
CINNASIL
PANRAY
TABLET; ORAL
MODERIL
PFIZER

RESERPINE
ELIXIR; ORAL
SERPASIL
NOVARTIS
INJECTABLE; INJECTION
SANDRIL
LILLY
SERPASIL
NOVARTIS
TABLET; ORAL
HISERPIA
BOWMAN PHARMS
RAU-SED
BRISTOL MYERS SQUIBB

RESERPINE
BARR
BELL PHARMA

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DISCONTINUED DRUG PRODUCT LIST

6 - 294 (of 346)

RESERPINE
TABLET; ORAL
RESERPINE
BUNDY
ELKINS SINN
EVERYLIFE

HALSEY

IMPAX LABS
IVAX SUB TEVA PHARMS
MARSHALL PHARMA
MK LABS
MYLAN
PHARMAVITE
PUREPAC PHARM
PVT FORM

REXALL
ROXANE
SOLVAY
TABLICAPS
TEVA
VALEANT PHARM INTL
WATSON LABS

WEST WARD

WHITEWORTH TOWN PLSN

SANDRIL
LILLY
SERPANRAY
PANRAY

SERPASIL
NOVARTIS

SERPATE
VALE

0.1MG
0.25MG
0.1MG
0.25MG
0.1MG
0.25MG
0.5MG
1MG
0.1MG
0.25MG
1MG
0.1MG
0.25MG
0.1MG
0.25MG
0.1MG
0.25MG
0.1MG
0.25MG
1MG
0.25MG
0.1MG
0.25MG
0.1MG
0.25MG
0.25MG
1MG
0.25MG
0.1MG
0.25MG
0.25MG
0.25MG
0.1MG
0.25MG
0.1MG
0.25MG
0.1MG
0.25MG
0.25MG
1MG
0.1MG
0.25MG
1MG
0.1MG
0.25MG
1MG

N009663
N009663
A083145
A083145
N010441
N010441
N010441
N010441
A080457
A080457
A080457
N009627
N009627
N011185
N011185
A080492
A080492
A080525
A080525
A084974
A084663
A080753
A080753
A086117
A080582
A085775
A080582
A080637
N009859
N009859
A080446
A085207
A089020
A089019
N009667
N009667
A080679
A080393
A085401
A080749
A080975
A080975
A080975
A080723
A080723
A080723

001
003
001
002
001
002
003
004
002
001
003
001
002
001
002
001
002
002
001
001
001
002
001
001
001
001
002
001
001
002
001
001
001
001
001
002
001
001
001
001
001
002
003
001
002
003

0.1MG
0.25MG

N009376
N009376

004
001

0.1MG
0.25MG
1MG

N009391
N009391
N009391

001
002
004

0.1MG
0.25MG
1MG

N009115
N009115
N009115

001
003
004

0.1MG
0.25MG

N009453
N009453

001
002

Mar 07, 1985

Mar 07, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 295 (of 346)

RESERPINE
TABLET; ORAL
SERPIVITE
VITARINE

0.25MG

N009645

002

N012972

001

N012972

002

N012265

003

A085248

001

400MG

N021511

002

300MG

N050429

001

N019650

001

Sep 17, 1993

A076375

001

Jan 14, 2003

75MG

N020835

004

Apr 16, 2007

5MG

N020272

005

Dec 29, 1993

0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG
0.5MG
1MG
2MG
3MG
4MG
0.25MG

A078071
A078071
A078071
A078071
A078071
A078071
A078828
A078828
A078828
A078828
A078828
A078828
A077784
A077784
A077784
A077784
A077784
A077784
A078187

001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001

Jun
Jun
Jun
Jun
Jun
Jun
Mar
Mar
Mar
Mar
Mar
Mar
Jun
Jun
Jun
Jun
Jun
Jun
Oct

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
TRICHLORMETHIAZIDE W/ RESERPINE
WATSON LABS
0.1MG;4MG

RIBAVIRIN
TABLET; ORAL
COPEGUS
ROCHE

Jun 21, 2005

RIFAMPIN
CAPSULE; ORAL
RIMACTANE
PROSAM LABS

RIMANTADINE HYDROCHLORIDE
SYRUP; ORAL
FLUMADINE
FOREST LABS
50MG/5ML
TABLET; ORAL
RIMANTADINE HYDROCHLORIDE
ACTAVIS TOTOWA
100MG

RISEDRONATE SODIUM
TABLET; ORAL
ACTONEL
WARNER CHILCOTT

RISPERIDONE
TABLET; ORAL
RISPERDAL
JANSSEN PHARMS
RISPERIDONE
ACTAVIS TOTOWA

CADISTA PHARMS

RATIOPHARM

SYNTHON PHARMS

17,
17,
17,
17,
17,
17,
23,
23,
23,
23,
23,
23,
08,
08,
08,
08,
08,
08,
22,

2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2010
2010
2010
2010
2010
2010
2009

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DISCONTINUED DRUG PRODUCT LIST

6 - 296 (of 346)

RISPERIDONE
TABLET; ORAL
RISPERIDONE
SYNTHON PHARMS

0.5MG
1MG
2MG
3MG
4MG

A078187
A078187
A078187
A078187
A078187

002
003
004
005
006

Oct
Oct
Oct
Oct
Oct

22,
22,
22,
22,
22,

2009
2009
2009
2009
2009

A071188
A071189
A071618
A071619

001
001
001
001

Jul
Jul
Feb
Feb

23,
23,
28,
28,

1987
1987
1991
1991

A071438

001

Jan 22, 1991

N018580
N018580

001
002

N018555

001

100MG

N020680

001

Mar 01, 1996

10MG/ML (10MG/ML)

N020214

002

Mar 17, 1994

12.5MG/5ML
25MG/5ML

N021052
N021052

001
002

May 20, 1999

May 20, 1999

12.5MG
25MG
50MG

N021042
N021042
N021042

001
002
003

May 20, 1999

May 20, 1999
Feb 25, 2000

N022008

002

Jun 13, 2008

N016224
N016224
N016224

001
002
003

N017318

001

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
HOSPIRA
30MG/100ML
YUTOPAR
ASTRAZENECA
10MG/ML
15MG/ML
TABLET; ORAL
YUTOPAR
ASTRAZENECA
10MG

RITONAVIR
CAPSULE; ORAL
NORVIR
ABBOTT

ROCURONIUM BROMIDE
INJECTABLE; INJECTION
ZEMURON
SCHERING

ROFECOXIB
SUSPENSION; ORAL
VIOXX
MERCK
TABLET; ORAL
VIOXX
MERCK

ROPINIROLE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
REQUIP XL
SMITHKLINE BEECHAM
EQ 3MG BASE

ROSE BENGAL SODIUM I-131

INJECTABLE; INJECTION
ROBENGATOPE
BRACCO

0.5mCi/VIAL
1mCi/VIAL
2mCi/VIAL

SODIUM ROSE BENGAL I 131

SORIN
0.5mCi/ML

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DISCONTINUED DRUG PRODUCT LIST

6 - 297 (of 346)

ROTIGOTINE
FILM, EXTENDED RELEASE; TRANSDERMAL
NEUPRO

UCB INC

2MG/24HR
4MG/24HR
6MG/24HR

N021829
N021829
N021829

001
002
003

May 09, 2007

May 09, 2007
May 09, 2007

100MG

N021911

001

Nov 14, 2008

10% (10GM/100ML)

N018203

001

20% (20GM/100ML)

N018614

001

N020236

001

Feb 04, 1994

200MG

N020828

001

Nov 07, 1997

EQ 0.6MG BASE/ML

N018009

001

100MG
100MG
100MG
100MG
100MG
100MG
50MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG

A084422
A084225
A085895
A084676
A085869
A085285
A085909
A085903
A084762
A084561
A085867
A085477
A085898
A086273
A085792
A084926
A085798
A086390

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

100MG/VIAL
50MG/ML

A083281
A083262

001
001

50MG/ML

N007392

002

RUFINAMIDE
TABLET; ORAL
BANZEL
EISAI INC

SAFFLOWER OIL
INJECTABLE; INJECTION
LIPOSYN 10%
ABBOTT
LIPOSYN 20%
ABBOTT

SALMETEROL XINAFOATE
AEROSOL, METERED; INHALATION
SEREVENT
GLAXOSMITHKLINE
EQ 0.021MG BASE/INH

SAQUINAVIR
CAPSULE; ORAL
FORTOVASE
HOFFMANN LA ROCHE

SARALASIN ACETATE
INJECTABLE; INJECTION
SARENIN
PROCTER AND GAMBLE

SECOBARBITAL SODIUM
CAPSULE; ORAL
SECOBARBITAL SODIUM
ANABOLIC
BARR
EVERYLIFE
HALSEY
IVAX PHARMS
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

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6 - 298 (of 346)

SECOBARBITAL SODIUM
SUPPOSITORY; RECTAL
SECONAL SODIUM
LILLY

30MG
60MG
120MG
200MG

A086530
A086530
A086530
A086530

001
002
003
004

75CU/VIAL

N018290

001

N021136

001

Apr 04, 2002

A075145

001

Sep 15, 2003

A074565
A074756
A074672
N019334
A074537
A074744

001
001
001
001
001
001

Aug
Nov
Apr
Jun
Aug
Jan

2.5%

A083892

001

2.5%
2.5%
2.5%

A084394
A085777
A086209

001
001
001

250uCi/ML
100uCi/ML
500uCi/ML

N017257
N017098
N017322

001
001
001

85-550uCi/ML

N017047

001

40 UNITS/ML
80 UNITS/ML

N017861
N017861

001
002

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

N019863
N020443
N020443

001
001
002

SECRETIN
INJECTABLE; INJECTION
SECRETIN-FERRING
FERRING

SECRETIN SYNTHETIC PORCINE

FOR SOLUTION; INTRAVENOUS
SECREFLO
CHIRHOCLIN
16MCG/VIAL

SELEGILINE HYDROCHLORIDE
CAPSULE; ORAL
SELEGILINE HYDROCHLORIDE
AAIPHARMA LLC
5MG
TABLET; ORAL
SELEGILINE HYDROCHLORIDE
ENDO PHARMS
5MG
IVAX SUB TEVA PHARMS 5MG
SIEGFRIED
5MG
SOMERSET
5MG
TEVA
5MG
5MG

02,
25,
01,
05,
02,
27,

1996
1998
1997
1989
1996
1997

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

SERACTIDE ACETATE
INJECTABLE; INJECTION
ACTHAR GEL-SYNTHETIC
ARMOUR PHARM

SERMORELIN ACETATE
INJECTABLE; INJECTION
GEREF
EMD SERONO

Dec 28, 1990

Sep 26, 1997
Sep 26, 1997

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DISCONTINUED DRUG PRODUCT LIST

6 - 299 (of 346)

SERTRALINE HYDROCHLORIDE
CONCENTRATE; ORAL
SERTRALINE HYDROCHLORIDE
ROXANE
EQ
TABLET; ORAL
SERTRALINE HYDROCHLORIDE
ACTAVIS ELIZABETH
EQ
EQ
EQ
ACTAVIS TOTOWA
EQ
EQ
EQ
IVAX SUB TEVA PHARMS EQ
EQ
EQ
MUTUAL PHARM
EQ
EQ
EQ
PLIVA HRVATSKA DOO
EQ
EQ
EQ
ROXANE
EQ
EQ
EQ
SANDOZ
EQ
EQ
EQ
WATSON LABS
EQ
EQ
EQ
ZOLOFT
PFIZER
EQ
EQ

20MG BASE/ML

A076934

001

Jun 30, 2006

25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE

A077345
A077345
A077345
A078175
A078175
A078175
A075719
A075719
A075719
A077818
A077818
A077818
A077299
A077299
A077299
A076881
A076881
A076881
A077713
A077713
A077713
A077162
A077162
A077162

001
002
003
001
002
003
003
001
002
001
002
003
001
002
003
001
002
003
001
002
003
001
002
003

Feb
Feb
Feb
Jul
Jul
Jul
Jun
Jun
Jun
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb

150MG BASE
200MG BASE

N019839
N019839

003
004

Dec 30, 1991

Dec 30, 1991

403MG

N020926

001

Oct 30, 1998

5MG
10MG
15MG

N020632
N020632
N020632

001
002
003

Nov 22, 1997

Nov 22, 1997
Nov 22, 1997

1%

N019608

001

Nov 30, 1989

7.5MG/ML

N020773

001

Oct 29, 1998

5MG
10MG
20MG
40MG

A078735
A078735
A078735
A078735

001
002
003
004

Aug
Aug
Aug
Aug

06,
06,
06,
21,
21,
21,
30,
30,
30,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,
06,

2007
2007
2007
2010
2010
2010
2006
2006
2006
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007

SEVELAMER HYDROCHLORIDE
CAPSULE; ORAL
RENAGEL
GENZYME

SIBUTRAMINE HYDROCHLORIDE
CAPSULE; ORAL
MERIDIA
ABBOTT

SILVER SULFADIAZINE
DRESSING; TOPICAL
SILDAFLO
FRANKLIN PHARMS

SIMETHICONE-CELLULOSE
SUSPENSION; ORAL
SONORX
BRACCO

SIMVASTATIN
TABLET; ORAL
SIMVASTATIN
ACTAVIS TOTOWA

30,
30,
30,
30,

2010
2010
2010
2010

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DISCONTINUED DRUG PRODUCT LIST

6 - 300 (of 346)

SIMVASTATIN
TABLET; ORAL
SIMVASTATIN
ACTAVIS TOTOWA
SANDOZ INC

80MG
5MG
10MG
20MG
40MG
80MG
TABLET, ORALLY DISINTEGRATING; ORAL
SIMVASTATIN
SYNTHON PHARMS
10MG
20MG
40MG
80MG

A078735
A077766
A077766
A077766
A077766
A077766

005
001
002
003
004
005

Aug
Dec
Dec
Dec
Dec
Dec

30,
20,
20,
20,
20,
20,

2010
2006
2006
2006
2006
2006

N021961
N021961
N021961
N021961

001
002
003
004

Oct
Oct
Oct
Oct

09,
09,
09,
09,

2007
2007
2007
2007

N021110

003

Feb 23, 2004

N019530

001

Dec 23, 1987

N019443
N019443

001
002

Jun 03, 1986

Jun 03, 1986

N018509

001

Aug 07, 1985

A088909

001

Feb 07, 1985

N017013
N017038

001
001

N018184
N018503

001
001

N019218
N018502

001
001

Jul 13, 1984

N019329

001

Apr 22, 1987

N019635

003

Mar 09, 1988

N019635

004

Mar 09, 1988

N018497
N017670
N018380

001
001
001

Feb 19, 1982

N018247

001

SIROLIMUS
TABLET; ORAL
RAPAMUNE
WYETH PHARMS INC

5MG

SODIUM BENZOATE; SODIUM PHENYLACETATE

SOLUTION; ORAL
UCEPHAN
B BRAUN

100MG/ML;100MG/ML

SODIUM BICARBONATE
INJECTABLE; INJECTION
SODIUM BICARBONATE IN PLASTIC CONTAINER
ABBOTT
0.9MEQ/ML
1MEQ/ML

SODIUM BICARBONATE; TARTARIC ACID

GRANULE, EFFERVESCENT; ORAL
BAROS
MALLINCKRODT LLC
460MG/GM;420MG/GM

SODIUM CHLORIDE
INJECTABLE; INJECTION
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABRAXIS PHARM
9MG/ML
SODIUM CHLORIDE
ABBOTT
20GM/100ML
B BRAUN
20GM/100ML
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN
450MG/100ML
MILES
450MG/100ML
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABBOTT
9MG/ML
MILES
900MG/100ML
SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER
ABRAXIS PHARM
234MG/ML
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
B BRAUN
3GM/100ML
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML
SOLUTION; IRRIGATION
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE
450MG/100ML
HOSPIRA
450MG/100ML
450MG/100ML
SODIUM CHLORIDE IN PLASTIC CONTAINER
MILES
900MG/100ML

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DISCONTINUED DRUG PRODUCT LIST

6 - 301 (of 346)

SODIUM CHROMATE CR-51

INJECTABLE; INJECTION
CHROMITOPE SODIUM
BRACCO
SODIUM CHROMATE CR 51
MALLINCKRODT

2mCi/VIAL

N013993

002

100uCi/ML

N016708

001

2mCi/ML

N017042

001

10-200mCi/ML

N022494

001

Jan 26, 2011

400uCi

N018671

003

May 27, 1982

1-130mCi
1-150mCi

N010929
N010929

001
003

50uCi
100uCi
0.8-100mCi
15-100uCi

N017316
N017316
N016515
N016517

001
002
002
002

7-106mCi/BOT

N010929

002

50mCi/ML

N017315

001

N018186
N018249

001
001

1.2%

N019518

002

Aug 06, 1986

1.2%

N019518

001

Jun 03, 1987

50MG/VIAL

N017546

001

50MG/VIAL
50MG/VIAL
50MG/VIAL

A071555
N018450
A070566

001
001
001

Jun 09, 1986

50MG/VIAL
50MG/VIAL
25MG/ML

A070031
N018581
A073465

001
001
001

Jan 17, 1985

Jul 28, 1982
Mar 30, 1992

SODIUM FLUORIDE F-18

INJECTABLE; INTRAVENOUS
FLUORINE F-18
GE HEALTHCARE
SODIUM FLUORIDE F 18
NIH NCI DCTD

SODIUM IODIDE I-123

CAPSULE; ORAL
SODIUM IODIDE I 123
SYNCOR PHARMS

SODIUM IODIDE I-131

CAPSULE; ORAL
IODOTOPE
BRACCO
SODIUM IODIDE I 131
CIS
MALLINCKRODT
SOLUTION; ORAL
IODOTOPE
BRACCO
SODIUM IODIDE I 131
CIS

SODIUM LACTATE
INJECTABLE; INJECTION
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
B BRAUN
1.87GM/100ML
HOSPIRA
1.87GM/100ML

SODIUM MONOFLUOROPHOSPHATE
GEL; DENTAL
EXTRA-STRENGTH AIM
CHESEBROUGH PONDS
PASTE; DENTAL
EXTRA-STRENGTH AIM
CHESEBROUGH PONDS

SODIUM NITROPRUSSIDE
INJECTABLE; INJECTION
NIPRIDE
ROCHE
NITROPRESS
ABBOTT
HOSPIRA
SODIUM NITROPRUSSIDE
ABRAXIS PHARM
BAXTER HLTHCARE
TEVA PARENTERAL

Nov 16, 1987

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6 - 302 (of 346)

SODIUM PHOSPHATE P-32

SOLUTION; INJECTION, ORAL
PHOSPHOTOPE
BRACCO
1-8mCi/VIAL
SODIUM PHOSPHATE P 32
MALLINCKRODT
0.67mCi/ML
1.5mCi/VIAL

N010927

001

N011777
N011777

001
002

A088786

001

Sep 11, 1984

A088717
A088453

001
001

Sep 11, 1984

Nov 17, 1983

30%

A080516

001

1%
3%

N005970
N005970

004
005

250MG/ML

N020166

001

Feb 14, 1992

5MG/VIAL
10MG/VIAL

N019107
N019107

001
002

Oct 17, 1985

Oct 24, 1989

10 IU/VIAL

N017726

001

2 IU/VIAL

N017726

002

4 IU/VIAL

N017992

001

5MG/ML (5MG/ML)

N021538

001

Jan 23, 2008

4.8MG/VIAL

N019774

001

May 25, 1995

2MG/VIAL

N019640

001

Jun 23, 1987

4MG/VIAL
8MG/VIAL

N019721
N019721

001
002

May 08, 1995

May 08, 1995

13.5MG/VIAL
18MG/VIAL
22.5MG/VIAL

N021075
N021075
N021075

001
002
003

Dec 22, 1999

Dec 22, 1999
Dec 22, 1999

SODIUM POLYSTYRENE SULFONATE

POWDER; ORAL, RECTAL
SODIUM POLYSTYRENE SULFONATE
WOCKHARDT
453.6GM/BOT
SUSPENSION; ORAL, RECTAL
SODIUM POLYSTYRENE SULFONATE
MORTON GROVE
15GM/60ML
ROXANE
15GM/60ML

SODIUM SUCCINATE
INJECTABLE; INJECTION
SODIUM SUCCINATE
ELKINS SINN

SODIUM TETRADECYL SULFATE

INJECTABLE; INJECTION
SOTRADECOL
ELKINS SINN

SODIUM THIOSULFATE
INJECTABLE; INJECTION
SODIUM THIOSULFATE
US ARMY

SOMATREM
INJECTABLE; INJECTION
PROTROPIN
GENENTECH

SOMATROPIN
INJECTABLE; INJECTION
ASELLACRIN 10
SERONO
ASELLACRIN 2
SERONO
CRESCORMON
GENENTECH

Jul 21, 1983

SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION
ACCRETROPIN
CANGENE
BIO-TROPIN
FERRING
HUMATROPE
LILLY
NORDITROPIN
NOVO NORDISK INC
NUTROPIN DEPOT
GENENTECH

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6 - 303 (of 346)

SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION
SAIZEN
EMD SERONO
SEROSTIM
EMD SERONO
ZORBTIVE
EMD SERONO

INJECTABLE; SUBCUTANEOUS
SEROSTIM LQ
EMD SERONO

4MG/VIAL
6MG/VIAL

N019764
N019764

005
001

Jan 16, 2007

Oct 08, 1996

8.8MG/VIAL

N020604

004

Sep 06, 2001

4MG/VIAL
5MG/VIAL
6MG/VIAL

N021597
N021597
N021597

001
002
003

Dec 01, 2003

Dec 01, 2003
Dec 01, 2003

6MG/0.5ML (6MG/0.5ML)

N020604

005

Feb 11, 2005

N018512

001

May 27, 1982

320MG

N019865

004

Oct 30, 1992

40MG
60MG
100MG

N021151
N021151
N021151

006
007
005

Apr 02, 2003

Apr 02, 2003
Mar 14, 2003

80MG
80MG
120MG
120MG
160MG
160MG
240MG
80MG
120MG
160MG
240MG

A075515
A076576
A075515
A076576
A075515
A076576
A075515
A075238
A075238
A075238
A075238

001
001
004
002
002
003
003
001
002
003
004

Oct
Apr
Oct
Apr
Oct
Apr
Oct
Jul
Jul
Jul
Jul

10%

N018465

001

Jun 29, 1983

20%

N018786

001

Jun 29, 1983

10%

N018660

001

Feb 26, 1982

20%

N018758

001

Feb 15, 1983

200MG

N020677

001

Dec 19, 1996

N050347
N050347

001
002

SORBITOL
SOLUTION; IRRIGATION
SORBITOL 3% IN PLASTIC CONTAINER
BAXTER HLTHCARE
3GM/100ML

SOTALOL HYDROCHLORIDE
TABLET; ORAL
BETAPACE
BAYER HLTHCARE
BETAPACE AF
BAYER HLTHCARE

SOTALOL HYDROCHLORIDE
MUTUAL PHARM

WATSON LABS

15,
08,
15,
08,
15,
08,
15,
13,
13,
13,
13,

2001
2004
2001
2004
2001
2004
2001
2000
2000
2000
2000

SOYBEAN OIL
INJECTABLE; INJECTION
SOYACAL 10%
ALPHA THERA
SOYACAL 20%
ALPHA THERA
TRAVAMULSION 10%
BAXTER HLTHCARE
TRAVAMULSION 20%
BAXTER HLTHCARE

SPARFLOXACIN
TABLET; ORAL
ZAGAM
MYLAN

SPECTINOMYCIN HYDROCHLORIDE
INJECTABLE; INJECTION
TROBICIN
PFIZER

EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL

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6 - 304 (of 346)

SPIRAPRIL HYDROCHLORIDE
TABLET; ORAL
RENORMAX
SCHERING

3MG
6MG
12MG
24MG

N020240
N020240
N020240
N020240

001
002
003
004

Dec
Dec
Dec
Dec

29,
29,
29,
29,

1994
1994
1994
1994

25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG
25MG

A087687
A087108
A087634
A087265
A087086
A087998
A088053
A089364
A087554
A087648
A087952
A086898
A087078

001
001
001
001
001
001
001
001
001
001
001
002
001

Oct 20, 1982

2MG

N012885

001

May 14, 1984

N020412

001

Jun 24, 1994

N021453
N021453
N021453
N021453

001
002
003
004

Dec
Dec
Dec
Dec

A089099
A089100

001
001

Dec 29, 1987

Dec 29, 1987

N019077

001

Mar 02, 1984

N018246

001

A060684
A060107
A060404
A060107
A060076
A060111

001
001
001
002
001
001

SPIRONOLACTONE
TABLET; ORAL
SPIRONOLACTONE
ASCOT
IVAX PHARMS
LEDERLE
MUTUAL PHARM
MYLAN
PUREPAC PHARM
SUPERPHARM
UPSHER SMITH
VANGARD
WARNER CHILCOTT
WATSON LABS

Oct 14, 1983

Aug 25, 1983
Nov 07, 1986
Feb 01, 1982
Nov 18, 1982
Mar 02, 1982

STANOZOLOL
TABLET; ORAL
WINSTROL
LUNDBECK INC

STAVUDINE
CAPSULE; ORAL
ZERIT
BRISTOL MYERS SQUIBB 5MG
CAPSULE, EXTENDED RELEASE; ORAL
ZERIT XR
BRISTOL MYERS SQUIBB 37.5MG
50MG
75MG
100MG

31,
31,
31,
31,

2002
2002
2002
2002

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
100%

STREPTOMYCIN SULFATE
INJECTABLE; INJECTION
STREPTOMYCIN SULFATE
COPANOS
LILLY

PFIZER

EQ
EQ
EQ
EQ
EQ
EQ

500MG BASE/ML
1GM BASE/VIAL
1GM BASE/2ML
5GM BASE/VIAL
1GM BASE/VIAL
1GM BASE/2.5ML

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6 - 305 (of 346)

STREPTOMYCIN SULFATE
INJECTABLE; INJECTION
STREPTOMYCIN SULFATE
PFIZER

EQ 5GM BASE/VIAL

A060076

002

N008453
N008453
N008453

003
001
004

N008845

002

A085400
A080997

001
001

N008847
N008847

001
003

A074406

001

A084015

001

N005963

002

A088000

001

A080028

002

A080020

002

A080660

001

A080660

002

N005963
N005963

001
003

A083021
A083021
A083021
A084143
A084145
A084146
A084147

001
002
003
001
001
001
001

A080025

001

A089047

001

A080024

001

A040215
A040216
A089068

001
001
001

SUCCINYLCHOLINE CHLORIDE
INJECTABLE; INJECTION
ANECTINE
SANDOZ

50MG/ML
500MG/VIAL
1GM/VIAL
QUELICIN PRESERVATIVE FREE
HOSPIRA
50MG/ML
SUCCINYLCHOLINE CHLORIDE
INTL MEDICATION
100MG/VIAL
ORGANON USA INC
20MG/ML
SUCOSTRIN
APOTHECON
20MG/ML
100MG/ML

Feb 04, 1982

SUFENTANIL CITRATE
INJECTABLE; INJECTION
SUFENTANIL CITRATE
WATSON LABS

EQ 0.05MG BASE/ML

Dec 15, 1995

SULFACETAMIDE SODIUM
OINTMENT; OPHTHALMIC
BLEPH-10
ALLERGAN
10%
SODIUM SULAMYD
SCHERING
10%
SULFAIR 10
PHARMAFAIR
10%
SOLUTION/DROPS; OPHTHALMIC
BLEPH-30
ALLERGAN
30%
ISOPTO CETAMIDE
ALCON
15%
OCUSULF-10
MIZA PHARMS USA
10%
OCUSULF-30
MIZA PHARMS USA
30%
SODIUM SULAMYD
SCHERING
10%
30%
SODIUM SULFACETAMIDE
AKORN
10%
15%
30%
SOLA BARNES HIND
10%
10%
30%
30%
SULF-10
NOVARTIS
10%
SULF-15
NOVARTIS
15%
SULFACEL-15
OPTOPICS
15%
SULFACETAMIDE SODIUM
AKORN
10%
30%
ALCON PHARMS LTD
30%

Dec 22, 1982

Oct 31, 1995

May 25, 1999

May 25, 1999
May 05, 1987

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6 - 306 (of 346)

SULFACETAMIDE SODIUM
SOLUTION/DROPS; OPHTHALMIC
SULFACETAMIDE SODIUM
10%
PHARMAFAIR
SULFAIR 10
10%
PHARMAFAIR
SULFAIR FORTE
30%
PHARMAFAIR
SULFAIR-15
15%
PHARMAFAIR
SULTEN-10
10%
BAUSCH AND LOMB

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

250MG

N017569

001

300MG
500MG
500MG
500MG
500MG
500MG

N004125
A080088
A080081
A080084
N004054
N004122

005
001
001
001
001
002

250MG/ML

N004054

002

250MG/5ML;250MG/5ML

N006317

007

500MG

N016000

002

1GM

A086012

001

500MG

A080273

001

250MG
500MG

N008565
N008565

001
004

500MG/5ML

N013664

002

500MG

N012715

002

1GM

N012715

003

SULFACYTINE
TABLET; ORAL
RENOQUID
GLENWOOD

SULFADIAZINE
TABLET; ORAL
SULFADIAZINE
ABBOTT
EVERYLIFE
IMPAX LABS
LANNETT
LEDERLE
LILLY

SULFADIAZINE SODIUM
INJECTABLE; INJECTION
SULFADIAZINE SODIUM
LEDERLE

SULFADIAZINE; SULFAMERAZINE
SUSPENSION; ORAL
SULFONAMIDES DUPLEX
LILLY

SULFAMETER
TABLET; ORAL
SULLA
BAYER HLTHCARE

SULFAMETHIZOLE
TABLET; ORAL
MICROSUL
FOREST PHARMS
PROKLAR
FOREST PHARMS
THIOSULFIL
WYETH AYERST

SULFAMETHOXAZOLE
SUSPENSION; ORAL
GANTANOL
ROCHE
TABLET; ORAL
GANTANOL
ROCHE
GANTANOL-DS
ROCHE

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SULFAMETHOXAZOLE
TABLET; ORAL
SULFAMETHOXAZOLE
ASCOT
BARR
HEATHER
SANDOZ
WATSON LABS
UROBAK
SHIONOGI

500MG
500MG
500MG
500MG
500MG
1GM

A087662
A087189
A086163
A085844
A085053
A086000

001
001
001
001
001
001

Oct 20, 1982

Jul 25, 1983

500MG

A087307

001

N018374

001

N018452

001

A070223
A070627
A070628
A072383
A073199
A071556

001
001
001
001
001
001

N017560

001

N017560

002

N017598

001

N017598

002

Feb 12, 1986

A070028
N018812
N018812
A077612

001
001
002
001

Jun
Jan
Jun
Nov

N018615

002

Jan 07, 1983

A070063

001

Aug 01, 1986

A070064

001

Aug 01, 1986

A072289
A072398
A072399

001
001
001

May 23, 1988

May 23, 1988
May 23, 1988

A070034

001

May 16, 1985

A070048

001

Mar 18, 1985

N018946
N018946
A071299
A071300
A072408
A070006
A071016
A070215

001
002
001
001
001
001
001
001

Aug
Aug
Oct
Oct
Dec
Nov
Aug
Sep

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
BAXTER HLTHCARE
80MG/ML;16MG/ML
80MG/ML;16MG/ML
BEDFORD
80MG/ML;16MG/ML
HOSPIRA
80MG/ML;16MG/ML
WATSON LABS
80MG/ML;16MG/ML
SUSPENSION; ORAL
BACTRIM
MUTUAL PHARM
200MG/5ML;40MG/5ML
BACTRIM PEDIATRIC
MUTUAL PHARM
200MG/5ML;40MG/5ML
SEPTRA
MONARCH PHARMS
200MG/5ML;40MG/5ML
SEPTRA GRAPE
MONARCH PHARMS
200MG/5ML;40MG/5ML
SULFAMETHOXAZOLE AND TRIMETHOPRIM
TEVA
200MG/5ML;40MG/5ML
200MG/5ML;40MG/5ML
200MG/5ML;40MG/5ML
TEVA PHARMS
200MG/5ML;40MG/5ML
SULFATRIM
ACTAVIS MID ATLANTIC 200MG/5ML;40MG/5ML
SULMEPRIM
USL PHARMA
200MG/5ML;40MG/5ML
SULMEPRIM PEDIATRIC
USL PHARMA
200MG/5ML;40MG/5ML
TRIMETH/SULFA
ALPHARMA US PHARMS
200MG/5ML;40MG/5ML
200MG/5ML;40MG/5ML
NASKA
200MG/5ML;40MG/5ML
TABLET; ORAL
COTRIM
TEVA
400MG;80MG
COTRIM D.S.
TEVA
800MG;160MG
SULFAMETHOXAZOLE AND TRIMETHOPRIM
HEATHER
400MG;80MG
800MG;160MG
INTERPHARM
400MG;80MG
800MG;160MG
MARTEC USA LLC
400MG;80MG
MUTUAL PHARM
400MG;80MG
400MG;80MG
PLIVA
400MG;80MG

Dec
Dec
Dec
Apr
Sep
Dec

29,
29,
29,
29,
11,
29,

02,
28,
10,
13,

10,
10,
27,
27,
07,
14,
25,
10,

1987
1987
1987
1992
1992
1987

1987
1983
1983
2006

1984
1984
1987
1987
1988
1984
1986
1985

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DISCONTINUED DRUG PRODUCT LIST

6 - 308 (of 346)

SULFAMETHOXAZOLE; TRIMETHOPRIM
TABLET; ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM
PLIVA
800MG;160MG
ROXANE
400MG;80MG
SANDOZ
400MG;80MG
400MG;80MG
800MG;160MG
TEVA
400MG;80MG
800MG;160MG
USL PHARMA
400MG;80MG
800MG;160MG
WATSON LABS
400MG;80MG
400MG;80MG
800MG;160MG
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
MARTEC USA LLC
800MG;160MG
MUTUAL PHARM
800MG;160MG
ROXANE
800MG;160MG
WATSON LABS
800MG;160MG
SULFATRIM-DS
SUPERPHARM
800MG;160MG
SULFATRIM-SS
SUPERPHARM
400MG;80MG
UROPLUS DS
SHIONOGI
800MG;160MG
UROPLUS SS
SHIONOGI
400MG;80MG

A070216
A072768
A070889
N018598
A070890
N018242
N018242
A070203
A070204
A070002
N018852
A070000

001
001
001
003
001
001
002
001
001
001
001
001

Sep
Aug
Nov
May
Nov

10,
30,
13,
19,
13,

1985
1991
1986
1982
1986

Nov
Nov
Nov
May
Nov

08,
08,
07,
09,
07,

1985
1985
1984
1983
1984

A072417
A070007
A072769
N018854

001
001
001
001

Dec
Nov
Aug
May

07,
14,
30,
09,

1988
1984
1991
1983

A070066

001

Jun 24, 1985

A070065

002

Jun 24, 1985

A071816

001

Sep 28, 1987

A071815

001

Sep 28, 1987

15%

A088718

001

Sep 19, 1985

1.05GM

N006530

004

Jan 27, 1987

500MG/5ML

N013093

001

500MG

N013092

002

500MG

N000159

001

250MG/5ML

N018605

001

500MG

A083450

001

500MG
500MG
500MG
500MG
500MG

A080197
A089590
A086184
A089339
A084964

001
001
001
001
001

SULFANILAMIDE
CREAM; VAGINAL
SULFANILAMIDE
TEVA
SUPPOSITORY; VAGINAL
AVC
AZUR PHARMA

SULFAPHENAZOLE
SUSPENSION; ORAL
SULFABID
PHARM RES ASSOC
TABLET; ORAL
SULFABID
PURDUE FREDERICK

SULFAPYRIDINE
TABLET; ORAL
SULFAPYRIDINE
LILLY

SULFASALAZINE
SUSPENSION; ORAL
AZULFIDINE
PHARMACIA AND UPJOHN
TABLET; ORAL
S.A.S.-500
SOLVAY
SULFASALAZINE
HERITAGE PHARMS INC
MUTUAL PHARM
SANDOZ
SUPERPHARM
WATSON LABS

Oct 19, 1987

Oct 26, 1987

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DISCONTINUED DRUG PRODUCT LIST

6 - 309 (of 346)

SULFASALAZINE
TABLET, DELAYED RELEASE; ORAL
SULFASALAZINE
500MG
WATSON LABS

A088052

001

200MG

N011556

004

200MG
200MG
200MG
200MG

A087666
A087770
A088934
A088666

001
001
001
001

100MG

N011556

003

100MG
100MG
100MG
100MG

A087665
A087769
A088933
A087667

001
001
001
001

500MG

N006525

001

500MG

A080036

001

500MG

A080366

001

500MG

A084955

001

500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG

A084031
A080189
A080109
A080142
A080085
A087649
A084385
A080087
A080082
A085628
A080268
A087332
A085534
A080379

001
001
001
001
001
001
001
001
001
001
002
001
001
001

500MG

A080040

001

EQ 1GM BASE/5ML

N009182

009

EQ 500MG BASE/5ML

N009182

004

EQ 500MG BASE/5ML

N009182

002

May 24, 1983

SULFINPYRAZONE
CAPSULE; ORAL
ANTURANE
NOVARTIS
SULFINPYRAZONE
BARR
IVAX PHARMS
PAR PHARM
VANGARD
TABLET; ORAL
ANTURANE
NOVARTIS
SULFINPYRAZONE
BARR
IVAX PHARMS
PAR PHARM
WATSON LABS

SULFISOXAZOLE
TABLET; ORAL
GANTRISIN
ROCHE
SOSOL
MK LABS
SOXAZOLE
ALRA
SULFALAR
PARKE DAVIS
SULFISOXAZOLE
BARR
HEATHER
IMPAX LABS
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

Sep
Nov
Sep
Feb

17,
19,
06,
17,

1982
1982
1985
1984

Sep
Jun
Sep
May

17,
01,
06,
26,

1982
1982
1985
1982

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6 - 310 (of 346)

SULFISOXAZOLE DIOLAMINE
INJECTABLE; INJECTION
GANTRISIN
ROCHE
EQ
OINTMENT; OPHTHALMIC
GANTRISIN
ROCHE
EQ
SOLUTION/DROPS; OPHTHALMIC
GANTRISIN
ROCHE
EQ
SULFISOXAZOLE DIOLAMINE
SOLA BARNES HIND
EQ

400MG BASE/ML

N006917

001

4% BASE

N008414

002

4% BASE

N007757

002

4% BASE

A084148

001

N006044

003

33.32%

N002918

001

150MG

N017911

001

150MG
200MG
150MG
200MG
150MG
200MG

A073262
A073262
A072712
A072713
A072972
A072973

002
001
001
001
001
001

Sep
Sep
Aug
Aug
Feb
Feb

10MG/SPRAY

N020626

002

Aug 26, 1997

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

A078318
A078318

001
002

Feb 06, 2009

Feb 06, 2009

EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE

A078241
A078241
A078241

001
002
003

Aug 10, 2009

Aug 10, 2009
Aug 10, 2009

N019387

001

Dec 23, 1988

N012828

001

SULFOXONE SODIUM
TABLET, DELAYED RELEASE; ORAL
DIASONE SODIUM
ABBOTT
165MG

SULFUR
POWDER; TOPICAL
BENSULFOID
POYTHRESS

SULINDAC
TABLET; ORAL
CLINORIL
MERCK
SULINDAC
HERITAGE PHARMS INC
SANDOZ
TEVA

06,
06,
30,
30,
28,
28,

1991
1991
1991
1991
1992
1992

SUMATRIPTAN
SPRAY; NASAL
IMITREX
GLAXOSMITHKLINE

SUMATRIPTAN SUCCINATE
INJECTABLE; SUBCUTANEOUS
SUMATRIPTAN SUCCINATE
TEVA PARENTERAL
TABLET; ORAL
SUMATRIPTAN SUCCINATE
ROXANE

SUPROFEN
SOLUTION/DROPS; OPHTHALMIC
PROFENAL
ALCON
1%

SUTILAINS
OINTMENT; TOPICAL
TRAVASE
ABBOTT

82,000 UNITS/GM

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6 - 311 (of 346)

TACRINE HYDROCHLORIDE
CAPSULE; ORAL
COGNEX
SHIONOGI INC

EQ
EQ
EQ
EQ

10MG
20MG
30MG
40MG

BASE
BASE
BASE
BASE

N020070
N020070
N020070
N020070

001
002
003
004

Sep
Sep
Sep
Sep

09,
09,
09,
09,

1993
1993
1993
1993

120MG

N009410

005

EQ 10MG BASE/5ML

N021807

001

Oct 29, 2005

EQ 10MG BASE
EQ 20MG BASE

N017970
N017970

001
002

Mar 21, 1994

EQ
EQ
EQ
EQ
EQ
EQ
EQ

A075740
A075740
A074539
A076027
A076027
A074504
A074504

001
002
001
001
002
001
002

Feb
Feb
Mar
Feb
Feb
Apr
Apr

N017848

001

ALBUMIN
N/A

N017916

001

N/A

N017792

001

N/A

N017838

001

N/A

N017833

001

N/A

N017842

001

N/A

N017773

001

N018263

001

N017775

001

TALBUTAL
TABLET; ORAL
LOTUSATE
SANOFI AVENTIS US

TAMOXIFEN CITRATE
SOLUTION; ORAL
SOLTAMOX
ROSEMONT
TABLET; ORAL
NOLVADEX
ASTRAZENECA
TAMOXIFEN CITRATE
IVAX SUB TEVA PHARMS
PHARMACHEMIE
ROXANE
TEVA

10MG
20MG
10MG
10MG
20MG
10MG
20MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE

20,
20,
31,
20,
20,
28,
28,

2003
2003
2003
2003
2003
2003
2003

TECHNETIUM TC-99M ALBUMIN AGGREGATED

INJECTABLE; INJECTION
TC 99M-LUNGAGGREGATE
GE HEALTHCARE

5mCi/ML

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

INJECTABLE; INJECTION
A-N STANNOUS AGGREGATED
SYNCOR PHARMS
AN-MAA
PHARMALUCENCE
LUNGAGGREGATE REAGENT
GE HEALTHCARE
MACROTEC
BRACCO
TECHNESCAN MAA
MALLINCKRODT
TECHNETIUM TC 99M MAA
GE HEALTHCARE

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

Mar 25, 1983

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6 - 312 (of 346)

TECHNETIUM TC-99M ALBUMIN MICROSPHERES KIT

INJECTABLE; INJECTION
INSTANT MICROSPHERES
3M

N/A

N017832

001

N020887

001

Sep 14, 1998

N021012

001

Aug 03, 1999

N017653

001

N017667

001

N017454

001

N017562

001

N017045

001

N/A

N017907

001

N/A

N018272

001

Jan 27, 1982

N018489

001

Oct 31, 1986

N018035

001

N018335

001

N017972

001

N018141
N018141

001
002

N017255

001

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
TECHNESCAN GLUCEPTATE
DRAXIMAGE

TECHNETIUM TC-99M LIDOFENIN KIT

INJECTABLE; INJECTION
TECHNESCAN HIDA
DRAXIMAGE

N/A

TECHNETIUM TC-99M MEDRONATE

INJECTABLE; INJECTION
DRAXIMAGE MDP-10
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

Aug 05, 1982

Jun 12, 1989

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6 - 313 (of 346)

TECHNETIUM TC-99M PENTETATE KIT

INJECTABLE; INJECTION
TECHNETIUM TC-99M PENTETATE KIT
GE HEALTHCARE
N/A

N017264

002

N017664

001

N017684

001

N017680

001

N020063

001

Jun 11, 1992

N019785

003

May 23, 1997

N017471
N017725
N017321
N017321
N017321

001
001
001
002
003

N017339

001

N017693

001

N017456

001

N017724

001

N017059

001

N017784

001

N016923

001

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
GE HEALTHCARE
MALLINCKRODT
PHARMALUCENCE

99M
2-100mCi/ML
10-60mCi/ML
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

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6 - 314 (of 346)

TECHNETIUM TC-99M TEBOROXIME KIT

INJECTABLE; INJECTION
CARDIOTEC
BRACCO

N/A

N019928

001

Dec 19, 1990

EQ 2MG BASE
EQ 6MG BASE

N021200
N021200

001
002

Jul 24, 2002

Jul 24, 2002

100MG/5ML

N022154

001

Apr 28, 2009

15MG
30MG

A070564
A070547

001
001

Oct 15, 1985

Oct 15, 1985

15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG

A071708
A071709
A071174
A071175
A070489
A070490
A070383
A070384

001
001
001
001
001
001
001
001

Sep
Sep
Jul
Jul
Jul
Jul
Mar
Mar

29,
29,
10,
10,
07,
07,
23,
23,

1988
1988
1986
1986
1986
1986
1987
1987

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

A075384
A075384
A075384
A075384
A075667
A075667
A075667
A075667

001
002
003
004
001
002
003
004

Dec
Dec
Dec
Dec
Jul
Jul
Jul
Jul

01,
01,
01,
01,
28,
28,
28,
28,

2000
2000
2000
2000
2000
2000
2000
2000

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

A074530
A074530
A074530
A074530
A074315
A074657
A074315
A074657
A074315
A074657
A074315
A074657
A074446
A074446
A074446
A074446

001
002
003
004
001
001
002
002
003
003
004
004
001
002
003
004

Apr
Apr
Apr
Apr
Dec
Apr
Dec
Apr
Dec
Apr
Dec
Apr
May
May
May
May

21,
21,
21,
21,
31,
28,
31,
28,
31,
28,
31,
28,
18,
18,
18,
18,

2000
2000
2000
2000
1998
2000
1998
2000
1998
2000
1998
2000
2000
2000
2000
2000

TEGASEROD MALEATE
TABLET; ORAL
ZELNORM
NOVARTIS

TELBIVUDINE
SOLUTION; ORAL
TYZEKA
NOVARTIS

TEMAZEPAM
CAPSULE; ORAL
TEMAZ
QUANTUM PHARMICS
TEMAZEPAM
DURAMED PHARMS BARR
MUTUAL PHARM
USL PHARMA
WATSON LABS

TERAZOSIN HYDROCHLORIDE
CAPSULE; ORAL
TERAZOSIN HYDROCHLORIDE
MYLAN TECHNOLOGIES
EQ
EQ
EQ
EQ
SANDOZ
EQ
EQ
EQ
EQ
TABLET; ORAL
TERAZOSIN HYDROCHLORIDE
IVAX SUB TEVA PHARMS EQ
EQ
EQ
EQ
SANDOZ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
TEVA
EQ
EQ
EQ
EQ

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TERBINAFINE
GEL; TOPICAL
LAMISIL
NOVARTIS

1%

N020846

001

Apr 29, 1998

N020192

001

Dec 30, 1992

N020749

001

Oct 17, 1997

A077065
A077223

001
001

Jul 02, 2007

Jul 02, 2007

N018762

001

Aug 17, 1984

N018000

001

Mar 19, 1985

N018571

001

N017466

001

N017849
N017849

001
002

N017618
N017618

001
002

N019498

001

Dec 23, 1987

0.75MG/3ML (0.25MG/ML)

N021318

001

Nov 26, 2002

100MG/ML

N016119

001

50MG
250MG

N016118
N016118

001
002

N020489
N020489

001
002

Sep 29, 1995

May 02, 1997

N019762
N019762

001
002

Oct 12, 1993

Oct 12, 1993

TERBINAFINE HYDROCHLORIDE
CREAM; TOPICAL
LAMISIL
NOVARTIS
1%
SOLUTION; TOPICAL
LAMISIL
NOVARTIS
1%
TABLET; ORAL
TERBINAFINE HYDROCHLORIDE
GEDEON RICHTER USA
EQ 250MG BASE
ROXANE
EQ 250MG BASE

TERBUTALINE SULFATE
AEROSOL, METERED; INHALATION
BRETHAIRE
NOVARTIS
0.2MG/INH
BRICANYL
SANOFI AVENTIS US
0.2MG/INH
INJECTABLE; INJECTION
BRETHINE
AAIPHARMA LLC
1MG/ML
BRICANYL
SANOFI AVENTIS US
1MG/ML
TABLET; ORAL
BRETHINE
LEHIGH VALLEY
2.5MG
5MG
BRICANYL
SANOFI AVENTIS US
2.5MG
5MG

TERIPARATIDE ACETATE
INJECTABLE; INJECTION
PARATHAR
SANOFI AVENTIS US

200 UNITS/VIAL

TERIPARATIDE RECOMBINANT HUMAN

INJECTABLE; SUBCUTANEOUS
FORTEO
LILLY

TESTOLACTONE
INJECTABLE; INJECTION
TESLAC
BRISTOL MYERS SQUIBB
TABLET; ORAL
TESLAC
BRISTOL MYERS SQUIBB

TESTOSTERONE
FILM, EXTENDED RELEASE; TRANSDERMAL
ANDRODERM
WATSON LABS
2.5MG/24HR
5MG/24HR
TESTODERM
ALZA
4MG/24HR
6MG/24HR

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TESTOSTERONE
FILM, EXTENDED RELEASE; TRANSDERMAL
TESTODERM TTS
ALZA
5MG/24HR
GEL; TRANSDERMAL
TESTOSTERONE
PAR PHARM
1% (2.5GM/PACKET)
1% (5GM/PACKET)
WATSON LABS
1% (2.5GM/PACKET)
1% (5GM/PACKET)
INJECTABLE; INJECTION
TESTOSTERONE
WATSON LABS
25MG/ML
50MG/ML
100MG/ML

N020791

001

Dec 18, 1997

A076744
A076744
A076737
A076737

001
002
001
002

May
May
Jan
Jan

A086420
A086419
A086417

001
001
001

May 10, 1983

Aug 23, 1983
Jul 07, 1983

50MG/ML

A085635

001

100MG/ML
100MG/ML
200MG/ML

A084401
A086029
A084401

001
001
002

200MG/ML

N009165

001

100MG/ML
100MG/ML
200MG/ML

A083667
A085599
A083667

001
001
002

INJECTABLE; INJECTION
TESTOSTERONE PROPIONATE
BEL MAR
25MG/ML
50MG/ML
100MG/ML
ELKINS SINN
25MG/ML
LILLY
50MG/ML
WATSON LABS
25MG/ML
25MG/ML
50MG/ML
50MG/ML
100MG/ML
100MG/ML

A080741
A080742
A080743
A080276
A080254
A080188
A085490
A080188
A085490
A080188
A083595

001
001
001
001
002
001
001
002
002
003
003

250MG
500MG

N050278
N050278

003
001

250MG
250MG
500MG
500MG

A061658
A061888
A061658
A061888

001
001
002
002

250MG
250MG
250MG

A061725
A062175
A062332

001
001
001

TESTOSTERONE CYPIONATE
INJECTABLE; INJECTION
DEPO-TESTOSTERONE
PHARMACIA AND UPJOHN
TESTOSTERONE CYPIONATE
WATSON LABS

TESTOSTERONE ENANTHATE
INJECTABLE; INJECTION
DELATESTRYL
ENDO PHARM
TESTOSTERONE ENANTHATE
WATSON LABS

TESTOSTERONE PROPIONATE

TETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL
ACHROMYCIN V
HERITAGE PHARMS INC
BRISTACYCLINE
BRISTOL

CYCLOPAR
WARNER CHILCOTT

23,
23,
27,
27,

2007
2007
2006
2006

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6 - 317 (of 346)

TETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL
CYCLOPAR
WARNER CHILCOTT
PANMYCIN
PHARMACIA AND UPJOHN
RETET
SOLVAY
ROBITET
WYETH AYERST
SUMYCIN
APOTHECON

TETRACHEL
ANGUS

500MG
500MG

A061725
A062332

002
002

250MG

A060347

001

250MG
500MG

A061443
A061443

001
002

250MG
500MG

A061734
A061734

001
002

100MG
125MG
250MG
500MG

A060429
A060429
A060429
A060429

002
004
001
003

A060343
A060343

001
003

A061802
A061802
A060059
A060173
A060173
A061148
A061148
A062752
A062752
A062085
A060736
A060736
A060783
A060783
A060290
A060290
A062686
A062686
A061214
A061471
A062540
A062540
A060471
A060471
A062300
A062300
A062103
A062343
A062103
A062343
A060768
A060768
A061685
A061685

001
002
001
001
002
001
002
001
002
001
001
002
001
002
001
002
001
002
002
001
001
002
001
002
001
002
001
001
002
002
001
002
001
002

A060082
A060082

003
004

N050653

001

250MG
500MG
TETRACYCLINE HYDROCHLORIDE
ABBOTT
250MG
500MG
ELKINS SINN
250MG
FERRANTE
125MG
250MG
HEATHER
250MG
500MG
LABS ATRAL
250MG
500MG
MAST MM
250MG
MUTUAL PHARM
250MG
500MG
MYLAN
250MG
500MG
PUREPAC PHARM
250MG
500MG
PVT FORM
250MG
500MG
ROXANE
500MG
SANDOZ
250MG
SUPERPHARM
250MG
500MG
VALEANT PHARM INTL
250MG
500MG
WARNER CHILCOTT
250MG
500MG
WATSON LABS
250MG
250MG
500MG
500MG
WEST WARD
250MG
500MG
WYETH AYERST
250MG
500MG
TETRACYN
PFIPHARMECS
250MG
500MG
FIBER, EXTENDED RELEASE; PERIODONTAL
ACTISITE
SCHIFF AND CO
12.7MG/FIBER

Aug 12, 1988

Aug 12, 1988

Jul 24, 1986

Jul 24, 1986

Mar 21, 1985

Mar 21, 1985

Mar 25, 1994

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DISCONTINUED DRUG PRODUCT LIST

6 - 318 (of 346)

TETRACYCLINE HYDROCHLORIDE
FOR SOLUTION; TOPICAL
TOPICYCLINE
SHIRE
INJECTABLE; INJECTION
ACHROMYCIN
LEDERLE
TETRACYN
PFIZER

2.2MG/ML

N050493

001

250MG/VIAL
500MG/VIAL

N050273
N050273

002
003

250MG/VIAL
500MG/VIAL

A060096
A060096

001
002

N050266

001

N050263

002

A060400

001

A060633
A060174
A060446
A060291

001
001
001
001

A060095

001

A061468

001

N050268

001

A061705
A061705

001
002

A061147
A061147
A061147
A061147

003
002
001
004

A061653
A061653
A061889
N050212
A061653
A061889
N050212

001
002
002
002
003
001
003

N018548
A075569

001
001

A085264
A085264

001
002

OINTMENT; OPHTHALMIC
ACHROMYCIN
STORZ
10MG/GM
SUSPENSION; ORAL
ACHROMYCIN V
LEDERLE
125MG/5ML
SUMYCIN
PAR PHARM
125MG/5ML
TETRACYCLINE HYDROCHLORIDE
ALPHARMA US PHARMS
125MG/5ML
FERRANTE
125MG/5ML
PROTER
125MG/5ML
PUREPAC PHARM
125MG/5ML
TETRACYN
PFIPHARMECS
125MG/5ML
TETRAMED
IVAX SUB TEVA PHARMS 125MG/5ML
SUSPENSION/DROPS; OPHTHALMIC
ACHROMYCIN
STORZ
1%
TABLET; ORAL
PANMYCIN
PHARMACIA AND UPJOHN 250MG
500MG
SUMYCIN
PAR PHARM
50MG
100MG
250MG
500MG

TETRACYCLINE PHOSPHATE COMPLEX

CAPSULE; ORAL
TETREX
BRISTOL

EQ
EQ
EQ
EQ
EQ
EQ
EQ

100MG
250MG
250MG
250MG
500MG
500MG
500MG

HCL
HCL
HCL
HCL
HCL
HCL
HCL

THALLOUS CHLORIDE TL-201

INJECTABLE; INJECTION
THALLOUS CHLORIDE TL 201
BRACCO
1mCi/ML
TRACE LIFE
1mCi/ML

THEOPHYLLINE
CAPSULE; ORAL
BRONKODYL
SANOFI AVENTIS US

100MG
200MG

Dec 30, 1982

Nov 21, 2001

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 319 (of 346)

THEOPHYLLINE
CAPSULE; ORAL
ELIXOPHYLLIN
FOREST LABS

100MG
200MG

A085545
A083921

001
001

Jul 31, 1984

Jul 31, 1984

100MG
200MG
250MG

A087155
A087155
A087155

001
002
003

Feb 25, 1985

Feb 25, 1985
Feb 25, 1985

100MG
200MG
SCHERER RP
100MG
200MG
250MG
CAPSULE, EXTENDED RELEASE; ORAL
AEROLATE III
FLEMING PHARMS
65MG
AEROLATE JR
FLEMING PHARMS
130MG
AEROLATE SR
FLEMING PHARMS
260MG
ELIXOPHYLLIN SR
FOREST LABS
125MG
250MG
SLO-BID
SANOFI AVENTIS US
50MG
75MG
100MG
125MG
200MG
300MG
SLO-PHYLLIN
SANOFI AVENTIS US
60MG
125MG
250MG
SOMOPHYLLIN-CRT
GRAHAM DM
50MG
100MG
200MG
250MG
300MG
THEOBID
WHITBY
260MG
THEOBID JR.
WHITBY
130MG
THEOCLEAR L.A.-130
SCHWARZ PHARMA
130MG
THEOCLEAR L.A.-260
SCHWARZ PHARMA
260MG
THEO-DUR
SCHERING
50MG
75MG
125MG
200MG
THEOPHYLLINE
CENT PHARMS
125MG
250MG
HOSPIRA
100MG
200MG
300MG
SANDOZ
260MG

A085263
A085263
A084731
A084731
A084731

001
002
002
001
003

Nov 07, 1986

Nov 07, 1986
Nov 07, 1986

A085075

003

Nov 24, 1986

A085075

002

Nov 24, 1986

A085075

001

Nov 24, 1986

A086826
A086826

001
002

Jan 29, 1985

Jan 29, 1985

A088269
A089539
A087892
A089540
A087893
A087894

001
001
001
001
001
001

Jan
May
Jan
May
Jan
Jan

A085206
A085203
A085205

001
001
001

May 24, 1982

May 24, 1982
May 24, 1982

A087763
A087194
A088382
A087193
A088383

001
001
001
001
001

Feb 27, 1985

A085983

001

Mar 20, 1985

A087854

001

Mar 20, 1985

A086569

001

May 27, 1982

A086569

002

May 27, 1982

A088022
A088015
A088016
A087995

001
001
001
001

Sep
Sep
Sep
Sep

10,
10,
10,
10,

1985
1985
1985
1985

A088654
A088689
A089976
A089977
A089932
A087462

001
001
001
001
001
001

Feb
Feb
Jan
Jan
Jan
May

12,
12,
04,
04,
04,
11,

1985
1985
1995
1995
1995
1982

SOMOPHYLLIN-T
FISONS

THEOPHYLLINE
KV PHARM

31,
10,
31,
10,
31,
31,

1985
1989
1985
1989
1985
1985

Feb 27, 1985

Feb 27, 1985

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 320 (of 346)

THEOPHYLLINE
CAPSULE, EXTENDED RELEASE; ORAL
THEOPHYLLINE-SR
SCHERER RP
300MG
THEOPHYL-SR
ORTHO MCNEIL PHARM
125MG
250MG
THEOVENT
SCHERING
125MG
250MG
ELIXIR; ORAL
ELIXOMIN
CENCI
80MG/15ML
LANOPHYLLIN
LANNETT
80MG/15ML
THEOLIXIR
PANRAY
80MG/15ML
THEOPHYL-225
ORTHO MCNEIL PHARM
112.5MG/15ML
THEOPHYLLINE
ALPHARMA US PHARMS
80MG/15ML
CENCI
80MG/15ML
HALSEY
80MG/15ML
PERRIGO
80MG/15ML
PHARM ASSOC
80MG/15ML
PRECISION DOSE
80MG/15ML
ROXANE
80MG/15ML
TARO
80MG/15ML
WOCKHARDT
80MG/15ML
INJECTABLE; INJECTION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
40MG/100ML
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
80MG/100ML
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
160MG/100ML
THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
200MG/100ML
200MG/100ML
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN
4MG/ML
400MG/100ML
400MG/100ML
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA INC
80MG/100ML
200MG/100ML
400MG/100ML
SOLUTION; ORAL
AEROLATE
FLEMING PHARMS
150MG/15ML
THEOLAIR
3M
80MG/15ML
THEOPHYLLINE
ROXANE
80MG/15ML
SUSPENSION; ORAL
ELIXICON
FOREST LABS
100MG/5ML
SYRUP; ORAL
ACCURBRON
SANOFI AVENTIS US
150MG/15ML
AQUAPHYLLIN
FERNDALE LABS
80MG/15ML
SLO-PHYLLIN
SANOFI AVENTIS US
80MG/15ML

A088255

001

Jun 12, 1986

A086480
A086471

001
001

Feb 08, 1985

Feb 08, 1985

A087010
A087910

001
001

Jan 31, 1985

Jan 31, 1985

A088303

001

Jan 25, 1984

A084578

001

A084559

001

A086485

001

A089223
A087679
A085169
A085952
A086720
A085863
A084739
A089626
A086748

001
001
001
001
001
001
001
001
001

May 27, 1988

Apr 15, 1982

N019083

001

Nov 07, 1984

N019083

002

Nov 07, 1984

N019083

003

Nov 07, 1984

N019212
N019826

001
004

Nov 07, 1984

Aug 14, 1992

N019212
N019212
N019826

003
002
005

Nov 07, 1984

Nov 07, 1984
Aug 14, 1992

N019211
N019211
N019211

002
004
005

Dec 14, 1984

Dec 14, 1984
Dec 14, 1984

A089141

001

Dec 03, 1986

A086107

001

A087449

001

A085502

001

A088746

001

Nov 22, 1985

A087917

001

Jan 18, 1983

A085187

001

Oct 28, 1988

Sep 15, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 321 (of 346)

THEOPHYLLINE
SYRUP; ORAL
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;
DURAPHYL
FOREST LABS

LABID
WARNER CHILCOTT
QUIBRON-T/SR
MONARCH PHARMS
SUSTAIRE
ROERIG
THEO-DUR
SCHERING

THEOLAIR-SR
3M

THEOPHYLLINE
ABLE

T-PHYL
PHARM RES ASSOC
UNI-DUR
SCHERING
UNIPHYL
PURDUE PHARM PRODS

80MG/15ML

A087095

001

80MG/15ML
150MG/15ML

A086001
A086545

001
001

300MG

A088656

001

100MG
200MG

A085202
A085204

001
001

100MG

A085353

002

200MG

A085353

001

225MG

A084726

001

100MG
ORAL

A086506

001

Sep 12, 1985

100MG
200MG
300MG

A088503
A088504
A088505

001
001
001

Apr 03, 1985

Apr 03, 1985
Apr 03, 1985

250MG

A087225

001

300MG

A087563

001

100MG
300MG

A085665
A085665

001
002

100MG
200MG
300MG
450MG

A085328
A086998
A085328
A089131

001
001
002
001

Jun 25, 1986

200MG
250MG
300MG
500MG

A088369
A086363
A088364
A089132

001
002
001
001

Jul
Jul
Jul
Jul

16,
16,
16,
16,

1987
1987
1987
1987

300MG
400MG
450MG
600MG

A040548
A040543
A040546
A040539

001
001
001
001

Apr
Apr
Apr
Apr

30,
27,
30,
27,

2004
2004
2004
2004

200MG

A088253

001

Aug 17, 1983

400MG
600MG

A089822
A089823

001
001

Jan 04, 1995

Jan 04, 1995

400MG
600MG

A087571
A040086

001
001

Sep 01, 1982

Apr 15, 1996

N006333

008

THEOPHYLLINE SODIUM GLYCINATE

ELIXIR; ORAL
SYNOPHYLATE
CENT PHARMS

EQ 165MG BASE/15ML

Mar 01, 1982

Aug 22, 1985

Jun 21, 1983

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 322 (of 346)

THEOPHYLLINE SODIUM GLYCINATE

TABLET; ORAL
ASBRON
NOVARTIS

EQ 150MG BASE

A085148

001

500MG/5ML

N016097

001

500MG

N016096

001

100MG/ML

A080853

001

100MG/ML
100MG/ML
100MG/ML
100MG/ML
200MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
100MG/ML
200MG/ML
100MG/ML

A080509
A087968
A080575
A080718
A080712
A083775
A040079
A080667
A080770
A083534
A083534
A080553

001
001
001
001
001
001
001
001
001
001
002
001

1GM/VIAL
5GM/VIAL
10GM/VIAL

N007600
N007600
N007600

003
005
009

5MG/ML

N012754

002

10MG

N013247

001

10MG

N012753

001

400MG/GM

N011679

001

EQ 25MG HCL/5ML
EQ 100MG HCL/5ML

N017923
N017923

001
002

THIABENDAZOLE
SUSPENSION; ORAL
MINTEZOL
MERCK
TABLET, CHEWABLE; ORAL
MINTEZOL
MERCK

THIAMINE HYDROCHLORIDE
INJECTABLE; INJECTION
BETALIN S
LILLY
THIAMINE HYDROCHLORIDE
ABRAXIS PHARM
AKORN
BAXTER HLTHCARE
BEL MAR
DELL LABS
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

Oct 01, 1982

May 03, 1996

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 323 (of 346)

THIORIDAZINE HYDROCHLORIDE
CONCENTRATE; ORAL
MELLARIL
NOVARTIS

30MG/ML
100MG/ML
THIORIDAZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 100MG/ML
ALPHARMA US PHARMS
30MG/ML
HI TECH PHARMA
30MG/ML
100MG/ML
PHARM ASSOC
30MG/ML
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

N011808
N011808

012
018

A088229
A087766
A040125
A040126
A040187
A040213
A088307
A088308
A089602
A089603
A088258
A088227

001
001
001
001
001
001
001
001
001
001
001
001

Aug
Apr
Aug
Aug
Aug
May
Nov
Nov
Nov
Nov
Jul
Jul

A088941
A088942

001
001

Dec 16, 1985

Dec 16, 1985

N011808
N011808
N011808
N011808
N011808
N011808
N011808

003
016
006
011
009
017
015

A088270
A088271
A088272
A088194
A088273
A088375
A088461
A087264
A088370
A088379
A088737
A088738
A088332
A088333
A088334
A088335
A088351
A088352
A088336
A088322
A088480
A089764
A089765
A088663
A088664
A088665
A089048
A088131
A088132
A088133
A088134
A088135

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Apr
Apr
Apr
Apr
Oct
Nov
Nov
Nov
Nov
Nov
Sep
Oct
Jun
Jun
Jun
Nov
Dec
Dec
Dec
Dec
Dec
Feb
Feb
Mar
Mar
Mar
Feb
Aug
Aug
Aug
Aug
Nov

23,
26,
16,
16,
28,
29,
23,
23,
09,
09,
25,
05,

14,
14,
14,
14,
03,
18,
18,
18,
18,
16,
26,
16,
27,
27,
27,
18,
05,
05,
05,
05,
29,
09,
09,
15,
15,
15,
26,
30,
30,
30,
30,
20,

1983
1983
1996
1996
1997
1998
1983
1983
1987
1987
1983
1983

1983
1983
1983
1983
1983
1983
1983
1983
1983
1983
1984
1984
1983
1983
1983
1983
1983
1983
1983
1983
1983
1988
1988
1984
1984
1984
1985
1983
1983
1983
1983
1984

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 324 (of 346)

THIORIDAZINE HYDROCHLORIDE
TABLET; ORAL
THIORIDAZINE HYDROCHLORIDE
SANDOZ
150MG
200MG
SUPERPHARM
10MG
25MG
50MG
TEVA
10MG
100MG
WATSON LABS
10MG
10MG
10MG
15MG
15MG
15MG
25MG
25MG
25MG
25MG
50MG
50MG
50MG
100MG
100MG
100MG
150MG
150MG
200MG
200MG
WEST WARD
10MG
15MG
25MG
50MG

A088136
A088137
A089103
A089104
A089105
A088493
A088456
A088412
A088476
A088561
A088345
A088477
A088562
A088296
A088478
A088567
A088755
A088323
A088479
A088563
A088284
A088564
A088736
A088410
A088869
A088381
A088872
A088658
A088659
A088660
A088661

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Sep
Sep
Jul
Jul
Jul
May
May
Sep
Nov
May
Jul
Nov
May
Jul
Nov
May
Jul
Jul
Nov
May
Aug
May
Jul
Mar
Jun
Mar
Apr
Mar
Mar
Mar
Mar

17,
17,
02,
02,
02,
17,
17,
12,
08,
11,
28,
08,
11,
28,
08,
11,
24,
28,
08,
11,
25,
11,
24,
05,
28,
14,
26,
26,
26,
26,
26,

1986
1986
1985
1985
1985
1985
1985
1983
1983
1984
1983
1983
1984
1983
1983
1984
1984
1983
1983
1984
1983
1984
1984
1984
1985
1984
1985
1984
1984
1984
1984

15MG/VIAL

N020058

001

Dec 22, 1994

15MG/VIAL
15MG/VIAL
15MG/VIAL
30MG/VIAL

A075698
N011683
A075730
A075730

001
001
001
002

Sep 20, 2001

20MG

N016584

005

1MG
2MG
5MG
10MG
20MG
1MG
2MG
5MG
10MG
10MG

A071884
A071885
A071886
A071887
A072200
A070600
A071626
A071627
A070603
A071628

001
001
001
001
001
001
001
001
001
001

THIOTEPA
INJECTABLE; INJECTION
THIOPLEX
IMMUNEX
THIOTEPA
APP PHARMS
IMMUNEX
TEVA PARENTERAL

Apr 20, 2001

Apr 20, 2001

THIOTHIXENE
CAPSULE; ORAL
NAVANE
PFIZER
THIOTHIXENE
AM THERAP

WATSON LABS

Aug
Aug
Aug
Aug
Dec
Jun
Jun
Jun
Jun
Jun

12,
12,
12,
12,
17,
05,
25,
25,
05,
25,

1987
1987
1987
1987
1987
1987
1987
1987
1987
1987

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 325 (of 346)

THIOTHIXENE HYDROCHLORIDE
CONCENTRATE; ORAL
NAVANE
PFIZER
EQ 5MG BASE/ML
THIOTHIXENE HYDROCHLORIDE
ALPHARMA US PHARMS
EQ 5MG BASE/ML
PACO
EQ 1MG BASE/ML
EQ 5MG BASE/ML
TEVA
EQ 5MG BASE/ML
TEVA PHARMS
EQ 5MG BASE/ML
THIOTHIXENE HYDROCHLORIDE INTENSOL
ROXANE
EQ 5MG BASE/ML
INJECTABLE; INJECTION
NAVANE
PFIZER
EQ 2MG BASE/ML
EQ 10MG BASE/VIAL

N016758

001

A070969
A071917
A071939
A071184
A071554

001
001
001
001
001

Oct
Sep
Dec
Jun
Oct

A073494

001

Jun 30, 1992

N016904
N016904

001
002

16MG
32MG
65MG
100MG
130MG
200MG
325MG

N002245
N002245
N002245
N002245
N002245
N002245
N002245

009
005
002
008
010
007
004

64.8MG

A080151

001

10 IU/VIAL

N008682

001

20MG

N020646

004

EQ
EQ
EQ
EQ
EQ
EQ

N050497
A062690
N050497
N050497
N050497
N050497

001
001
002
003
004
005

Apr 04, 1984

N019979
N019979

001
002

Mar 24, 1993

Oct 31, 1991

A075253
A075316
A075318
A075309

001
001
001
001

Aug
Nov
Aug
Apr

16,
20,
16,
22,
16,

1987
1989
1988
1987
1987

THYROGLOBULIN
TABLET; ORAL
PROLOID
PARKE DAVIS

THYROGLOBULIN
IMPAX LABS

THYROTROPIN
INJECTABLE; INJECTION
THYTROPAR
SANOFI AVENTIS US

TIAGABINE HYDROCHLORIDE
TABLET; ORAL
GABITRIL
CEPHALON

Sep 30, 1997

TICARCILLIN DISODIUM
INJECTABLE; INJECTION
TICAR
GLAXOSMITHKLINE

1GM BASE/VIAL
3GM BASE/VIAL
3GM BASE/VIAL
6GM BASE/VIAL
20GM BASE/VIAL
30GM BASE/VIAL

Dec 19, 1986

TICLOPIDINE HYDROCHLORIDE
TABLET; ORAL
TICLID
ROCHE PALO

125MG
250MG
TICLOPIDINE HYDROCHLORIDE
ACTAVIS ELIZABETH
250MG
MYLAN
250MG
SANDOZ
250MG
WATSON LABS
250MG

20,
02,
20,
26,

1999
1999
1999
2000

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 326 (of 346)

TIMOLOL MALEATE
SOLUTION/DROPS; OPHTHALMIC
TIMOLOL MALEATE
AKORN
EQ 0.25% 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

A074465
A074667
A074668

001
001
001

Mar 25, 1997

Mar 25, 1997
Mar 25, 1997

N018017
N018017
N018017

001
002
004

A072466
A072467
A072468
A072550
A072551
A072552
A072648
A072649
A072650
A072001
A072002
A072003
A072269
A072917
A072270
A072918
A072271
A072919

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

May
May
May
Apr
Apr
Apr
Jun
Jun
Jun
Apr
Apr
Apr
Apr
Jul
Apr
Jul
Apr
Jul

N018682

001

Feb 18, 1983

EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) N020912

EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)
N020913

001
001

May 14, 1998

May 14, 1998

19,
19,
19,
13,
13,
13,
16,
16,
16,
11,
11,
11,
11,
31,
11,
31,
11,
31,

1989
1989
1989
1989
1989
1989
1993
1993
1993
1989
1989
1989
1989
1991
1989
1991
1989
1991

TIOCONAZOLE
CREAM; TOPICAL
TZ-3
PFIZER

1%

TIROFIBAN HYDROCHLORIDE
INJECTABLE; INJECTION
AGGRASTAT
MEDICURE

TIZANIDINE HYDROCHLORIDE
TABLET; ORAL
TIZANIDINE HYDROCHLORIDE
ACTAVIS ELIZABETH
EQ
EQ
ACTAVIS TOTOWA
EQ
EQ
BARR
EQ
EQ
IVAX SUB TEVA PHARMS EQ
EQ
ZANAFLEX
ACORDA
EQ

2MG
4MG
2MG
4MG
2MG
4MG
2MG
4MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A076283
A076283
A076281
A076281
A076371
A076371
A076321
A076321

001
002
001
002
001
002
001
002

Jul
Jul
Oct
Oct
Apr
Apr
Sep
Sep

12,
12,
20,
20,
09,
09,
30,
30,

2002
2002
2003
2003
2003
2003
2004
2004

2MG BASE

N020397

002

Feb 04, 2000

A063176

001

May 25, 1994

TOBRAMYCIN
SOLUTION/DROPS; OPHTHALMIC
TOBRAMYCIN
ALCON UNIVERSAL
0.3%

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 327 (of 346)

TOBRAMYCIN SULFATE
INJECTABLE; INJECTION
NEBCIN
LILLY

TOBRAMYCIN SULFATE
APOTHECON
ASTRAZENECA

BAXTER HLTHCARE

HOSPIRA
MARSAM PHARMS LLC

EQ
EQ
EQ
EQ
EQ

10MG BASE/ML
10MG BASE/ML
10MG BASE/ML
40MG BASE/ML
1.2GM BASE/VIAL

A062008
A062707
N050477
A062008
N050519

004
001
005
001
001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

40MG
40MG
10MG
40MG
40MG
40MG
10MG
10MG
40MG
40MG
10MG
40MG
40MG

A064021
A064026
A063119
A063120
A063121
A063122
A063113
A063128
A063118
A063127
A063080
A063161
A062945

002
001
001
001
001
001
001
001
001
001
001
001
002

May
May
Oct
Oct
Oct
Oct
Apr
Nov
Jul
Nov
Apr
May
Aug

400MG
600MG

N018257
N018257

001
002

Nov 09, 1984

Nov 09, 1984

100MG
250MG
500MG
100MG
250MG
500MG
250MG
500MG
100MG
250MG
500MG
100MG
250MG
500MG
100MG
250MG
500MG
100MG
250MG
500MG
250MG
500MG
100MG
250MG
500MG
100MG
100MG
250MG
500MG

A070162
A070163
A070164
A070165
A070166
A070167
A071270
A071271
N018894
N018894
N018894
A071357
A071358
A071359
A070159
A070160
A070161
A071633
A070289
A070290
A070763
A070764
A071355
A070168
A070169
A070242
A070513
A070243
A070244

001
001
001
001
001
001
001
001
001
002
003
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jan
Jan
Jan
Jan
Jan
Jan
Sep
Sep
Nov
Nov
Nov
Jul
Jul
Jul
Jan
Jan
Jan
Dec
Mar
Mar
Jun
Jun
Jan
Apr
Apr
Aug
Jan
Aug
Aug

100MG

N015500

002

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

Apr 29, 1987

31,
31,
31,
31,
31,
31,
26,
27,
29,
27,
30,
29,
09,

1994
1994
1994
1994
1994
1994
1991
1991
1991
1991
1991
1991
1989

TOCAINIDE HYDROCHLORIDE
TABLET; ORAL
TONOCARD
ASTRAZENECA

TOLAZAMIDE
TABLET; ORAL
TOLAZAMIDE
BARR

DURAMED PHARMS BARR

INTERPHARM
IVAX SUB TEVA PHARMS

MUTUAL PHARM

PAR PHARM

SANDOZ

SUPERPHARM
USL PHARMA

WATSON LABS

TOLINASE
PHARMACIA AND UPJOHN

14,
14,
14,
10,
10,
10,
23,
23,
02,
02,
02,
16,
16,
16,
06,
06,
06,
09,
13,
13,
16,
16,
11,
02,
02,
01,
09,
01,
01,

1986
1986
1986
1986
1986
1986
1986
1986
1984
1984
1984
1987
1987
1987
1986
1986
1986
1987
1986
1986
1986
1986
1988
1986
1986
1986
1986
1986
1986

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DISCONTINUED DRUG PRODUCT LIST

6 - 328 (of 346)

TOLAZAMIDE
TABLET; ORAL
TOLINASE
PHARMACIA AND UPJOHN

250MG
500MG

N015500
004
N015500
005

25MG/ML

N006403
005

250MG
500MG

N010670
002
N010670
001

500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
500MG
250MG
500MG

A086141
A087541
A087121
A086926
A087093
A086047
A088950
A086574
N012678
A088893
A087876
A089110
A089111

001
001
001
001
001
001
001
001
001
001
001
001
001

EQ 1GM BASE/VIAL

N012095

001

200MG

N020697

002

EQ 400MG BASE

N018084

001

EQ
EQ
EQ
EQ
EQ

BASE
BASE
BASE
BASE
BASE

A073308
A073392
A073311
A073462
A073519

001
001
001
001
001

EQ 200MG BASE

N017628

001

EQ 600MG BASE

N017628

002

Mar 08, 1989

EQ
EQ
EQ
EQ
EQ

A073527
A074399
A073588
A074002
A074729

001
001
001
001
001

Jun
Mar
Jul
Sep
Feb

TOLAZOLINE HYDROCHLORIDE
INJECTABLE; INJECTION
PRISCOLINE
NOVARTIS

Feb 22, 1985

TOLBUTAMIDE
TABLET; ORAL
ORINASE
PHARMACIA AND UPJOHN
TOLBUTAMIDE
ALRA
ASCOT
BARR
CLONMEL HLTHCARE
IVAX PHARMS
PARKE DAVIS
PUREPAC PHARM
SANDOZ
SUPERPHARM
VANGARD
WATSON LABS

Mar 01, 1983

Jun 17, 1985

Nov
Apr
May
May

19,
20,
29,
29,

1984
1982
1987
1987

TOLBUTAMIDE SODIUM
INJECTABLE; INJECTION
ORINASE DIAGNOSTIC
PHARMACIA AND UPJOHN

TOLCAPONE
TABLET; ORAL
TASMAR
VALEANT PHARM INTL

Jan 29, 1998

TOLMETIN SODIUM
CAPSULE; ORAL
TOLECTIN DS
ORTHO MCNEIL JANSSEN
TOLMETIN SODIUM
ACTAVIS ELIZABETH
IVAX SUB TEVA PHARMS
MUTUAL PHARM
SANDOZ
TEVA
TABLET; ORAL
TOLECTIN
ORTHO MCNEIL JANSSEN
TOLECTIN 600
ORTHO MCNEIL JANSSEN
TOLMETIN SODIUM
ACTAVIS ELIZABETH
IVAX SUB TEVA PHARMS
SANDOZ
TEVA

400MG
400MG
400MG
400MG
400MG

600MG
600MG
200MG
600MG
600MG

BASE
BASE
BASE
BASE
BASE

Jan
Jan
Nov
Apr
May

24,
24,
27,
30,
29,

30,
28,
31,
27,
27,

1992
1992
1991
1992
1992

1992
1996
1992
1993
1997

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DISCONTINUED DRUG PRODUCT LIST

6 - 329 (of 346)

TOLVAPTAN
TABLET; ORAL
SAMSCA
OTSUKA AMERICA PHARM

60MG

N022275

003

May 19, 2009

50MG

N020844

003

Oct 26, 1998

15MG
25MG

A076448
A076448

001
002

Apr 15, 2009

Apr 15, 2009

300MG
400MG

N020505
N020505

003
006

Dec 24, 1996

Dec 24, 1996

25MG
100MG
200MG
25MG
50MG
100MG
200MG
25MG
50MG
100MG
200MG

A076315
A076315
A076315
A077905
A077905
A077905
A077905
A076306
A076306
A076306
A076306

001
002
003
001
002
003
004
001
002
003
004

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

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

EQ 3MG BASE/3ML (EQ 1MG BASE/ML)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

N200199
N200199
N200199

001
002
003

Feb 25, 2011

Feb 25, 2011
Feb 25, 2011

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

N020137
N020137

002
001

Aug 23, 1993

Aug 23, 1993

50MG
50MG
50MG

A075960
A075974
A075963

001
001
001

Jun 19, 2002

Jul 12, 2002
Jul 03, 2002

100MG

N020281

001

Mar 03, 1995

500MG

N019280

001

Dec 30, 1986

N021257

001

Mar 16, 2001

TOPIRAMATE
CAPSULE; ORAL
TOPAMAX SPRINKLE
JANSSEN PHARMS
TOPIRAMATE
BARR
TABLET; ORAL
TOPAMAX
JANSSEN PHARMS
TOPIRAMATE
BARR

PLIVA HRVATSKA DOO

ROXANE

27,
27,
27,
30,
30,
30,
30,
27,
27,
27,
27,

2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009

TOPOTECAN HYDROCHLORIDE
SOLUTION; INTRAVENOUS
TOPOTECAN
SANDOZ INC

TORSEMIDE
INJECTABLE; INJECTION
DEMADEX
ROCHE

TRAMADOL HYDROCHLORIDE
TABLET; ORAL
TRAMADOL HYDROCHLORIDE
ACTAVIS ELIZABETH
ASTA
IVAX SUB TEVA PHARMS
ULTRAM
JANSSEN PHARMS

TRANEXAMIC ACID
TABLET; ORAL
CYKLOKAPRON
PHARMACIA AND UPJOHN

TRAVOPROST
SOLUTION/DROPS; OPHTHALMIC
TRAVATAN
ALCON PHARMS LTD
0.004%

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 330 (of 346)

TRAZODONE HYDROCHLORIDE
TABLET; ORAL
DESYREL
APOTHECON

50MG
100MG
150MG
300MG

N018207
N018207
N018207
N018207

001
002
003
004

Mar 25, 1985

Nov 07, 1988

A071139
A071140
A071405
A071406
A070921
A072484
A072483
A074357
A070491
A070492
A071112
A071113

001
001
001
001
001
001
001
001
001
001
001
001

Oct
Oct
Feb
Feb
Dec
Apr
Apr
Apr
Apr
Apr
Nov
Nov

A070942

001

Dec 01, 1986

10MG

N020438

001

Nov 22, 1995

0.05%

A074873

001

Jun 19, 1998

0.05%

N016921

002

1MG
2MG
4MG
8MG
16MG

N011161
N011161
N011161
N011161
N011161

009
004
007
011
010

1MG
2MG
4MG
8MG

N011283
N011283
N011283
N011283

003
008
006
010

2MG
2MG
4MG
4MG
8MG
8MG
4MG
4MG
2MG
2MG
4MG
2MG
4MG
8MG
4MG

A084286
A084318
A084267
A084319
A084268
A084320
A084340
A083750
A084406
A084020
A084020
A084708
A084709
A084707
A085601

001
001
001
001
001
001
001
001
001
002
003
001
001
001
001

TRAZODONE HYDROCHLORIDE
AM THERAP
50MG
100MG
MYLAN
50MG
100MG
QUANTUM PHARMICS
100MG
50MG
SANDOZ
100MG
150MG
TEVA
50MG
USL PHARMA
100MG
50MG
WATSON LABS
100MG
TRIALODINE
QUANTUM PHARMICS
50MG

29,
29,
27,
27,
01,
30,
30,
30,
29,
29,
17,
17,

1986
1986
1991
1991
1986
1990
1990
1997
1987
1987
1986
1986

TRETINOIN
CAPSULE; ORAL
VESANOID
ROCHE
SOLUTION; TOPICAL
TRETINOIN
TEVA PHARMS
SWAB; TOPICAL
RETIN-A
ORTHO JANSSEN

TRIAMCINOLONE
TABLET; ORAL
ARISTOCORT
ASTELLAS

KENACORT
BRISTOL MYERS SQUIBB

TRIAMCINOLONE
BARR

IMPAX LABS
IVAX SUB TEVA PHARMS
MYLAN
PUREPAC PHARM
ROXANE

SANDOZ

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DISCONTINUED DRUG PRODUCT LIST

6 - 331 (of 346)

TRIAMCINOLONE
TABLET; ORAL
TRIAMCINOLONE
TEVA
WATSON LABS

4MG
4MG
4MG

A084775
A084270
A085834

001
001
001

0.055MG/INH

N019798

001

0.025%
0.1%
0.5%

A083017
A083016
A083015

003
004
002

0.025%
0.025%
0.1%
0.1%
0.5%
0.5%

A083017
A088818
A083016
A088819
A083015
A088820

004
001
005
001
003
001

0.025%
0.1%
0.5%

A085539
A085539
A085539

001
002
003

0.5%

A083943

001

0.1%

A086240

001

0.1%

A084908

002

0.1%

A087113

001

0.1%
0.025%
0.025%
0.1%
0.025%
0.1%
0.5%
0.025%
0.1%
0.5%
0.025%
0.1%
0.5%
0.025%
0.025%
0.1%
0.5%

A087798
A087797
A087932
A089798
A088094
A088095
A088096
A087990
A087991
A087992
A087921
A087912
A087922
A040038
A089274
A089275
A089276

001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001
001

Jun
Jun
May
May
Sep
Sep
Sep
Jul
Jul
Jul
Aug
Aug
Aug
Oct
Feb
Feb
Feb

0.025%
0.1%
0.5%

A087430
A087429
A087428

001
001
001

Nov 01, 1988

Nov 01, 1988
Nov 01, 1988

0.025%
0.1%
0.5%

A088196
A088197
A088198

001
001
001

Mar 25, 1983

Mar 25, 1983
Mar 25, 1983

TRIAMCINOLONE ACETONIDE
AEROSOL, METERED; NASAL
NASACORT
SANOFI AVENTIS US
CREAM; TOPICAL
ARISTOCORT
ASTELLAS

ARISTOCORT A
ASTELLAS

FLUTEX
IVAX PHARMS

KENALOG
APOTHECON
KENALOG-H
APOTHECON
TRIACET
TEVA
TRIACORT
SOLVAY
TRIAMCINOLONE ACETONIDE
ACTAVIS MID ATLANTIC
ALPHARMA US PHARMS
AMBIX
G AND W LABS
MORTON GROVE

PHARMADERM

PHARMAFAIR

TARO
TOPIDERM

TRIATEX
IVAX PHARMS

TRYMEX
SAVAGE LABS

Jul 11, 1991

Oct 16, 1984

Oct 16, 1984
Oct 16, 1984

04,
07,
09,
31,
01,
01,
01,
07,
07,
07,
10,
10,
10,
26,
21,
21,
21,

1982
1982
1983
1991
1983
1983
1983
1983
1983
1983
1982
1982
1982
1994
1989
1989
1989

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

DISCONTINUED DRUG PRODUCT LIST

6 - 332 (of 346)

TRIAMCINOLONE ACETONIDE
GEL; TOPICAL
ARISTOGEL
ASTELLAS
INJECTABLE; INJECTION
TRIAMCINOLONE ACETONIDE
PARNELL
WATSON LABS
LOTION; TOPICAL
KENALOG
APOTHECON

0.1%

A083380

001

3MG/ML
40MG/ML

N019503
A085825

001
001

0.025%
0.1%
0.025%
0.1%

A084343
A084343
N011602
N011602

001
002
003
001

A087191
A087192

001
001

A080750
A080745

004
002

A080750
A088780
A080745
A088781

003
001
003
001

A087375
A087377
A087376

001
001
001

A083944

001

A087799
A089913
A089795
A089796
A088090
A088091
A088092
A088692
A088690

001
001
001
001
001
001
001
001
001

Jun
Dec
Dec
Dec
Sep
Sep
Sep
Aug
Aug

A088693
A088691

001
001

Aug 02, 1984

Aug 02, 1984

N012097

001

A071383

001

Jul 06, 1987

N020120

001

Feb 04, 2000

N020784

001

Apr 07, 2004

25MG/ML
40MG/ML

N011685
N012802

003
001

TRIAMCINOLONE DIACETATE
AKORN
25MG/ML
40MG/ML

A085122
A086394

001
001

BRISTOL MYERS SQUIBB

TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS
0.025%
0.1%
OINTMENT; TOPICAL
ARISTOCORT
ASTELLAS
0.1%
0.5%
ARISTOCORT A
ASTELLAS
0.1%
0.1%
0.5%
0.5%
FLUTEX
IVAX PHARMS
0.025%
0.1%
0.5%
KENALOG
APOTHECON
0.5%
TRIAMCINOLONE ACETONIDE
ACTAVIS MID ATLANTIC 0.1%
ALPHARMA US PHARMS
0.5%
G AND W LABS
0.025%
0.1%
MORTON GROVE
0.025%
0.1%
0.5%
PHARMADERM
0.025%
0.1%
TRYMEX
SAVAGE LABS
0.025%
0.1%
PASTE; DENTAL
KENALOG IN ORABASE
APOTHECON
0.1%
ORALONE
TARO
0.1%
SPRAY, METERED; NASAL
ALLERNAZE
LUPIN ATLANTIS
0.05MG/SPRAY
NASACORT HFA
SANOFI AVENTIS US
0.055MG/SPRAY

TRIAMCINOLONE DIACETATE
INJECTABLE; INJECTION
ARISTOCORT
SANDOZ

Oct 16, 1987

Sep 08, 1982

Sep 08, 1982

Oct 01, 1984

Oct 05, 1984
Nov 01, 1988
Nov 01, 1988
Nov 01, 1988

07,
23,
23,
23,
01,
01,
01,
02,
02,

1982
1988
1988
1988
1983
1983
1983
1984
1984

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DISCONTINUED DRUG PRODUCT LIST

6 - 333 (of 346)

TRIAMCINOLONE DIACETATE
INJECTABLE; INJECTION
TRIAMCINOLONE DIACETATE
WATSON LABS
40MG/ML
40MG/ML
SYRUP; ORAL
ARISTOCORT
ASTELLAS
2MG/5ML
KENACORT
BRISTOL MYERS SQUIBB EQ 4MG BASE/5ML

A084072
A085529

001
001

N011960

004

N012515

001

0.5MG

N017892

002

Nov 15, 1982

2MG
4MG

N012594
N012594

001
002

Jun 16, 1988

Jun 16, 1988

2MG
4MG

N012265
N012265

001
002

4MG
4MG

A083436
A085630

001
001

4MG

A086259

001

4MG
2MG
4MG
4MG
4MG
2MG
2MG
4MG
4MG
4MG

A083967
A087007
A087005
A086171
A085568
A083847
A086458
A083462
A083855
A085962

001
001
001
001
001
001
001
001
001
001

1.5GM/15ML

N016830

001

750MG

N016809

002

10MG/ML

N009729

001

25MG

N009489

005

N011552

006

A085787

001

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

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
EQ 10MG BASE/ML
TRIFLUOPERAZINE HYDROCHLORIDE
SANDOZ
EQ 10MG BASE/ML

Apr 15, 1982

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6 - 334 (of 346)

TRIFLUOPERAZINE HYDROCHLORIDE
CONCENTRATE; ORAL
TRIFLUOPERAZINE HYDROCHLORIDE
WOCKHARDT
EQ 10MG BASE/ML
INJECTABLE; INJECTION
STELAZINE
GLAXOSMITHKLINE
EQ 2MG BASE/ML
TABLET; ORAL
STELAZINE
GLAXOSMITHKLINE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
TRIFLUOPERAZINE HYDROCHLORIDE
DURAMED PHARMS BARR
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
IVAX PHARMS
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
SANDOZ
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
WATSON LABS
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE

A088143

001

N011552

005

N011552
N011552
N011552
N011552

001
002
003
004

A088967
A088968
A088969
A088970
A087612
A087613
A087328
A087614
A040153
A040153
A040153
A040153
A085975
A085976
A085973
A088710

001
001
001
001
001
001
001
001
001
002
003
004
001
001
001
001

N011491

004

3MG/ML
10MG/ML
20MG/ML

N011325
N011325
N011325

005
004
001

10MG
25MG
50MG

N011123
N011123
N011123

001
002
003

N006773
N012947

010
001

N006773

009

A089514

001

N006773
N006773

005
003

A080381

001

Jul 26, 1983

Apr
Apr
Apr
Apr
Nov
Nov
Nov
Nov
Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun

23,
23,
23,
23,
19,
19,
19,
19,
25,
25,
25,
25,
23,
23,
23,
23,

1985
1985
1985
1985
1982
1982
1982
1982
1996
1996
1996
1996
1988
1988
1988
1988

TRIFLUPROMAZINE
SUSPENSION; ORAL
VESPRIN
APOTHECON

EQ 50MG HCL/5ML

TRIFLUPROMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
VESPRIN
APOTHECON

TABLET; ORAL
VESPRIN
BRISTOL MYERS SQUIBB

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

Apr 07, 1989

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6 - 335 (of 346)

TRIHEXYPHENIDYL HYDROCHLORIDE
TABLET; ORAL
TREMIN
SCHERING
5MG
TRIHEXYPHENIDYL HYDROCHLORIDE
NYLOS
5MG
VANGARD
2MG
WATSON LABS
2MG
5MG

A080381

003

A085622
A088035
A085117
A085105

001
001
001
001

N018719
N018719

002
001

N011316

004

N011316

003

A085015
A088285

001
001

N011316

001

300MG

N005856

005

200MG/5ML

N005856

002

50MG/ML

N008983

001

A088960
A089043
A089094
A086577
A087939

001
001
001
001
001

Apr
Apr
Apr
Oct
Dec

100MG
200MG

N017943
N017943

001
003

Jul 14, 1982

100MG
200MG

A070494
A070495

001
001

Jan 22, 1986

Sep 24, 1986

100MG

N017952

001

Jul 30, 1982

TRILOSTANE
CAPSULE; ORAL
MODRASTANE
BIOENVISION

30MG
60MG

Dec 31, 1984

Dec 31, 1984

TRIMEPRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE; ORAL
TEMARIL
ALLERGAN HERBERT
EQ 5MG BASE
SYRUP; ORAL
TEMARIL
ALLERGAN HERBERT
EQ 2.5MG BASE/5ML
TRIMEPRAZINE TARTRATE
ALPHARMA US PHARMS
EQ 2.5MG BASE/5ML
MORTON GROVE
EQ 2.5MG BASE/5ML
TABLET; ORAL
TEMARIL
ALLERGAN HERBERT
EQ 2.5MG BASE

Feb 18, 1982

Apr 11, 1985

TRIMETHADIONE
CAPSULE; ORAL
TRIDIONE
ABBOTT
SOLUTION; ORAL
TRIDIONE
ABBOTT

TRIMETHAPHAN CAMSYLATE
INJECTABLE; INJECTION
ARFONAD
ROCHE

TRIMETHOBENZAMIDE HYDROCHLORIDE
INJECTABLE; INJECTION
TRIMETHOBENZAMIDE HYDROCHLORIDE
SMITH AND NEPHEW
100MG/ML
100MG/ML
SOLOPAK
100MG/ML
WATSON LABS
100MG/ML
100MG/ML

04,
04,
04,
19,
28,

1986
1986
1986
1982
1982

TRIMETHOPRIM
TABLET; ORAL
PROLOPRIM
MONARCH PHARMS
TRIMETHOPRIM
MUTUAL PHARM
TRIMPEX
ROCHE

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6 - 336 (of 346)

TRIMETHOPRIM
TABLET; ORAL
TRIMPEX 200
ROCHE

200MG

N017952

002

Nov 09, 1982

EQ 25MG BASE/5ML

A074374

001

Jun 23, 1995

EQ 25MG BASE/VIAL
EQ 200MG BASE/VIAL

N020326
N020326

001
002

Dec 17, 1993

Jul 31, 1998

EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE

A071283
A071284
A071285

001
001
001

Dec 08, 1987

Dec 08, 1987
Dec 08, 1987

5MG

N012697

001

EQ 25MG HCL/5ML

N005914

004

A083149
N005914

001
002

A083037
A080744
A083989
A080785
A083557
A085412
A083625
A083626
A080713
A080790
A085188

001
001
001
001
001
001
001
001
001
001
001

N010533
N010533

002
001

3.7%;2.86%;3.42%

A088607

001

3.7%;2.86%;3.42%

N005794

001

3.7%;2.86%;3.42%

A087864

001

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

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

Jun 09, 1986

Sep 01, 1982

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6 - 337 (of 346)

TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)

CREAM; VAGINAL
TRIPLE SULFA
FOUGERA
PERRIGO NEW YORK
TRYSUL
SAVAGE LABS
VAGILIA
TEVA
TABLET; VAGINAL
SULTRIN
ORTHO MCNEIL PHARM
TRIPLE SULFA
FOUGERA
PHARMADERM

3.7%;2.86%;3.42%
3.7%;2.86%;3.42%

A086424
A087285

001
001

Nov 15, 1982

3.7%;2.86%;3.42%

A087887

001

Jul 23, 1982

3.7%;2.86%;3.42%

A088821

001

Nov 09, 1987

184MG;143.75MG;172.5MG

N005794

002

184MG;143.75MG;172.5MG
184MG;143.75MG;172.5MG

A088463
A088462

001
001

Jan 03, 1985

Jan 03, 1985

N011496

002

Jul 01, 1983

A087963

001

Jan 18, 1983

A085940
A088735
A087514

001
001
001

Jan 17, 1985

Feb 10, 1982

N011110

002

Jul 01, 1983

A085610
A085094

001
001

TRIPROLIDINE HYDROCHLORIDE
SYRUP; ORAL
ACTIDIL
GLAXOSMITHKLINE
1.25MG/5ML
MYIDYL
USL PHARMA
1.25MG/5ML
TRIPROLIDINE HYDROCHLORIDE
ALPHARMA US PHARMS
1.25MG/5ML
HALSEY
1.25MG/5ML
PHARM ASSOC
1.25MG/5ML
TABLET; ORAL
ACTIDIL
GLAXOSMITHKLINE
2.5MG
TRIPROLIDINE HYDROCHLORIDE
VITARINE
2.5MG
WATSON LABS
2.5MG

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
SULFALOID
FOREST PHARMS
SULFA-TRIPLE #2
IMPAX LABS
SULFOSE
WYETH AYERST
TERFONYL
BRISTOL MYERS SQUIBB
TRIPLE SULFA
PUREPAC PHARM
TRIPLE SULFAS
LEDERLE

167MG/5ML;167MG/5ML;167MG/5ML

A080123

002

167MG/5ML;167MG/5ML;167MG/5ML

N006317

012

167MG/5ML;167MG/5ML;167MG/5ML

A080100

001

167MG/5ML;167MG/5ML;167MG/5ML

A080013

002

167MG/5ML;167MG/5ML;167MG/5ML

N006904

002

167MG/5ML;167MG/5ML;167MG/5ML

A080280

001

167MG/5ML;167MG/5ML;167MG/5ML

N006920

003

167MG;167MG;167MG

N006317

011

167MG;167MG;167MG

A080099

001

167MG;167MG;167MG

A080079

001

167MG;167MG;167MG

A080013

001

167MG;167MG;167MG

N006904

001

167MG;167MG;167MG

A080086

001

167MG;167MG;167MG

N006920

002

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6 - 338 (of 346)

TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)
TABLET; ORAL
TRIPLE SULFOID
PAL PAK

167MG;167MG;167MG

A080094

001

200MG
300MG
400MG

N020719
N020719
N020719

001
003
002

Jan 29, 1997

Aug 04, 1997
Jan 29, 1997

200MG
300MG
400MG

N020720
N020720
N020720

001
003
002

Jan 29, 1997

Aug 04, 1997
Jan 29, 1997

10%

N011340

002

EQ 250MG BASE

N050336

002

EQ 125MG BASE/5ML

N050332

001

N012111
N012111

002
004

A088274
A088230

001
001

Sep 16, 1983

Sep 16, 1983

A088447
A089172
A087636
A087637
A089171

001
001
001
001
001

Aug
Dec
Jul
Aug
Dec

EQ 100MG BASE
EQ 200MG BASE

N020759
N020759

001
002

Dec 18, 1997

Dec 18, 1997

3MG/ML
3MG/ML
3MG/ML

N005657
N006095
N006325

001
001
001

750MG

N013731

001

TROGLITAZONE
TABLET; ORAL
PRELAY
SANKYO

REZULIN
PFIZER PHARMS

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
0.5%
1%
MYDRIAFAIR
PHARMAFAIR
0.5%
1%
TROPICAMIDE
AKORN
1%
ALCON UNIVERSAL
1%
MIZA PHARMS USA
0.5%
1%
WATSON LABS
0.5%

28,
28,
30,
09,
28,

1985
1990
1982
1982
1990

TROVAFLOXACIN MESYLATE
TABLET; ORAL
TROVAN
PFIZER

TUBOCURARINE CHLORIDE
INJECTABLE; INJECTION
TUBOCURARINE CHLORIDE
BRISTOL MYERS SQUIBB
HOSPIRA
LILLY

TYROPANOATE SODIUM
CAPSULE; ORAL
BILOPAQUE
GE HEALTHCARE

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DISCONTINUED DRUG PRODUCT LIST

6 - 339 (of 346)

UNOPROSTONE ISOPROPYL
SOLUTION/DROPS; OPHTHALMIC
RESCULA
SUCAMPO PHARMS
0.15%

N021214

001

Aug 03, 2000

1MG

N012892

001

40GM/VIAL

N017698

001

40GM/VIAL

N012154

001

N021092

001

Dec 17, 1999

N020586

001

Sep 17, 1996

N020900

001

Feb 04, 1999

N019415
N019415

002
003

Sep 18, 1986

Sep 18, 1986

N019415
N019415

005
004

Aug 23, 1996

Aug 23, 1996

5,000 IU/VIAL
9,000 IU/VIAL
250,000 IU/VIAL

N021846
N021846
N021846

003
002
001

150MG

N019594

001

Dec 31, 1987

10MG
20MG

N021341
N021341

002
003

Nov 16, 2001

Nov 16, 2001

250MG
250MG
250MG

A070431
A070195
A070631

001
001
001

Feb 28, 1986

Jul 02, 1987
Jun 11, 1987

250MG/5ML

A077105

001

Jul 29, 2005

URACIL MUSTARD
CAPSULE; ORAL
URACIL MUSTARD
SHIRE

UREA
INJECTABLE; INJECTION
STERILE UREA
HOSPIRA
UREAPHIL
HOSPIRA

UREA C-13
FOR SOLUTION; ORAL
HELICOSOL
METABOLIC SOLUTIONS
125MG/VIAL
MERETEK UBT KIT (W/ PRANACTIN)
OTSUKA AMERICA
125MG/VIAL
PYLORI-CHEK BREATH TEST
DXS DEVICES
100MG/VIAL

UROFOLLITROPIN
INJECTABLE; INTRAMUSCULAR
METRODIN
SERONO
75 IU/AMP
150 IU/AMP
INJECTABLE; SUBCUTANEOUS
FERTINEX
SERONO
75 IU/AMP
150 IU/AMP

UROKINASE
INJECTABLE; INJECTION
KINLYTIC
MICROBIX BIOSYSTEMS

URSODIOL
CAPSULE; ORAL
ACTIGALL
WATSON PHARMS

VALDECOXIB
TABLET; ORAL
BEXTRA
GD SEARLE

VALPROIC ACID
CAPSULE; ORAL
VALPROIC ACID
PAR PHARM
SCHERER RP
USL PHARMA
SYRUP; ORAL
VALPROIC ACID
APOTEX INC

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6 - 340 (of 346)

VALSARTAN
CAPSULE; ORAL
DIOVAN
NOVARTIS

80MG
160MG

N020665
N020665

001
002

Dec 23, 1996

Dec 23, 1996

EQ 250MG BASE/5ML
EQ 500MG BASE/6ML

A061667
A061667

002
001

Jul 13, 1983

EQ 250MG BASE/5ML
EQ 500MG BASE/6ML

A063321
A063321

002
003

Oct 15, 1993

Oct 15, 1993

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

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

A060180
A062476
A062716
A062812
A060180
A062476
A062716
A062812
A062812

001
001
001
001
002
002
002
002
003

Mar
Mar
Nov
Mar
Mar
Mar
Nov
Nov

15,
13,
17,
21,
21,
13,
17,
17,

1984
1987
1987
1986
1986
1987
1987
1987

EQ
EQ
EQ
EQ
EQ

500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
5GM BASE/VIAL
10GM BASE/VIAL

A062682
A062682
A062682
A062682
A062682

001
002
003
004
005

Jul
Mar
May
May
May

22,
30,
11,
11,
11,

1986
1988
1988
1988
1988

500MG BASE/VIAL
1GM BASE/VIAL

A062879
A062879

001
002

Aug 02, 1988

Aug 02, 1988

500MG BASE/VIAL
1GM BASE/VIAL

A062956
A062956

001
002

Aug 01, 1988

Aug 01, 1988

5PRESSOR UNITS/ML

N003402

001

10MG/VIAL
20MG/VIAL

N018776
N018776

002
003

Apr 30, 1984

Jan 03, 1992

10MG/VIAL
20MG/VIAL
4MG/VIAL

A075218
A075218
A075558

001
002
001

Aug 23, 1999

Aug 23, 1999
Sep 11, 2001

200 UNITS/VIAL

N022575

002

Feb 26, 2010

N020699

003

Oct 20, 1997

VANCOMYCIN HYDROCHLORIDE
FOR SOLUTION; ORAL
VANCOCIN HYDROCHLORIDE
VIROPHARMA
VANCOLED
LEDERLE
INJECTABLE; INJECTION
VANCOCIN HYDROCHLORIDE
VIROPHARMA

VANCOLED
BAXTER HLTHCARE

VANCOMYCIN HYDROCHLORIDE
BAXTER HLTHCARE
EQ
EQ
VANCOR
PHARMACIA AND UPJOHN EQ
EQ

VASOPRESSIN TANNATE
INJECTABLE; INJECTION
PITRESSIN TANNATE
PARKE DAVIS

VECURONIUM BROMIDE
INJECTABLE; INJECTION
NORCURON
ORGANON USA INC
VECURONIUM BROMIDE
BAXTER HLTHCARE
HOSPIRA

VELAGLUCERASE ALFA
POWDER; IV (INFUSION)
VPRIV
SHIRE HUMAN GENETIC

VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
EFFEXOR XR
WYETH PHARMS INC
EQ 100MG BASE

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DISCONTINUED DRUG PRODUCT LIST

6 - 341 (of 346)

VENLAFAXINE HYDROCHLORIDE
TABLET; ORAL
EFFEXOR
WYETH PHARMS INC

EQ
EQ
EQ
EQ
EQ
EQ
VENLAFAXINE HYDROCHLORIDE
PLIVA HRVATSKA DOO
EQ
EQ
EQ
EQ
EQ
SANDOZ
EQ
EQ
EQ
EQ
EQ

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

N020151
N020151
N020151
N020151
N020151
N020151

001
002
006
003
004
005

Dec
Dec
Dec
Dec
Dec
Dec

28,
28,
28,
28,
28,
28,

1993
1993
1993
1993
1993
1993

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

A078517
A078517
A078517
A078517
A078517
A077515
A077515
A077515
A077515
A077515

001
002
003
004
005
001
002
003
004
005

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

13,
13,
13,
13,
13,
13,
13,
13,
13,
13,

2008
2008
2008
2008
2008
2008
2008
2008
2008
2008

N018925
N019038

001
001

Mar 30, 1984

Mar 30, 1984

N018485

001

A070348
A072888
A070577
A070739
A070740
A070225
A070617
A072233
A073485
A070696
A070697
A070695

001
001
001
001
001
001
001
001
001
001
001
001

May
Jul
Feb
May
May
Nov
Nov
Feb
Sep
Jul
Jul
Jul

N018817

004

Feb 23, 1988

N018593
N018593
N018593

003
001
002

Nov 23, 1987

Mar 08, 1982
Mar 08, 1982

A071019
A070468
A071880
A071881
A070482
A071489
A070483
A071489
A072751
A072124
A072125
A073168
A071423
A071424

001
001
001
001
001
002
001
001
001
001
001
001
001
001

Sep
Sep
Apr
Apr
Sep
Jan
Sep
Jan
Feb
Jan
Jan
Jul
May
May

VERAPAMIL HYDROCHLORIDE
INJECTABLE; INJECTION
CALAN
GD SEARLE LLC

2.5MG/ML
2.5MG/ML

ISOPTIN
FSC
2.5MG/ML
VERAPAMIL HYDROCHLORIDE
ABRAXIS PHARM
2.5MG/ML
BEDFORD
2.5MG/ML
HOSPIRA
2.5MG/ML
2.5MG/ML
2.5MG/ML
LUITPOLD
2.5MG/ML
2.5MG/ML
MARSAM PHARMS LLC
2.5MG/ML
2.5MG/ML
SMITH AND NEPHEW
2.5MG/ML
2.5MG/ML
SOLOPAK
2.5MG/ML
TABLET; ORAL
CALAN
GD SEARLE LLC
160MG
ISOPTIN
FSC
40MG
80MG
120MG
VERAPAMIL HYDROCHLORIDE
ACTAVIS ELIZABETH
80MG
120MG
HERITAGE PHARMS INC
80MG
120MG
MUTUAL PHARM
80MG
80MG
120MG
120MG
PLIVA
40MG
80MG
120MG
SANDOZ
40MG
80MG
120MG

01,
28,
02,
06,
06,
12,
12,
26,
27,
31,
31,
31,

24,
24,
05,
05,
24,
13,
24,
13,
23,
26,
26,
31,
24,
25,

1986
1995
1987
1987
1987
1985
1985
1993
1993
1987
1987
1987

1986
1986
1988
1988
1986
1988
1986
1988
1996
1989
1989
1992
1988
1988

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6 - 342 (of 346)

VERAPAMIL HYDROCHLORIDE
TABLET; ORAL
VERAPAMIL HYDROCHLORIDE
WARNER CHILCOTT
80MG
120MG
WATSON LABS
40MG
TABLET, EXTENDED RELEASE; ORAL
VERAPAMIL HYDROCHLORIDE
PLIVA
240MG

A070340
A070341
A072799

001
001
001

Sep 24, 1986

Sep 24, 1986
Apr 28, 1989

A072922

001

Mar 01, 1996

130CSR UNIT

N005691

002

EQ 187.4MG BASE/ML

N050523

001

3%

N050486

001

10MG/VIAL

N012665

001

10MG/VIAL
10MG/VIAL

A089011
A089565

001
001

Nov 18, 1985

Aug 18, 1987

1MG/VIAL
1MG/ML
5MG/VIAL

N014103
N014103
N014103

001
003
002

Mar 07, 1984

1MG/ML

A071426

001

Jul 17, 1987

5MG/VIAL

A070867

001

Jul 12, 1988

1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/VIAL
2MG/VIAL
5MG/VIAL

A070873
A070411
A076296
A076401
A071559
A071560
A071561

001
001
001
001
001
001
001

Feb
Sep
Dec
Oct
Apr
Apr
Apr

EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL

A061086
A061086

001
002

25,000USP UNITS
50,000USP UNITS

A083080
A083080

002
001

50,000USP UNITS

A083973

001

VERATRUM VIRIDE ROOT

TABLET; ORAL
VERTAVIS
MEDPOINTE PHARM HLC

VIDARABINE
INJECTABLE; INJECTION
VIRA-A
PARKEDALE
OINTMENT; OPHTHALMIC
VIRA-A
PARKEDALE

VINBLASTINE SULFATE
INJECTABLE; INJECTION
VELBAN
LILLY
VINBLASTINE SULFATE
ABRAXIS PHARM
HOSPIRA

VINCRISTINE SULFATE
INJECTABLE; INJECTION
ONCOVIN
LILLY

VINCASAR PFS
TEVA PARENTERAL
VINCREX
BRISTOL MYERS SQUIBB
VINCRISTINE SULFATE
ABIC
ABRAXIS PHARM
APP PHARMS
HOSPIRA

VIOMYCIN SULFATE
INJECTABLE; INJECTION
VIOCIN SULFATE
PFIZER

VITAMIN A
CAPSULE; ORAL
AQUASOL A
ASTRAZENECA
VITAMIN A
BANNER PHARMACAPS

19,
10,
20,
28,
11,
11,
11,

1987
1986
2002
2003
1988
1988
1988

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6 - 343 (of 346)

VITAMIN A
CAPSULE; ORAL
VITAMIN A
CHASE CHEM
EVERYLIFE
IMPAX LABS
WEST WARD

50,000 IU
50,000 IU
50,000USP UNITS
50,000USP UNITS

A083351
A083134
A080952
A080985

001
001
001
001

EQ 50,000 UNITS BASE

A083187

001

EQ 50,000 UNITS BASE

A080883

001

EQ 50,000 UNITS BASE

A080830

001

EQ 50,000 UNITS BASE

A080972

001

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

50,000
50,000
50,000
50,000
50,000
50,000
50,000
50,000
50,000
50,000
50,000
25,000
50,000
50,000
50,000

UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS
UNITS

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A080702
A080860
A080746
A083207
A085479
A080943
A083114
A080953
A080955
A083035
A083190
A083457
A083457
A080967
A083665

001
001
001
001
001
001
001
001
001
001
001
002
001
001
001

EQ
EQ
EQ
EQ

50,000
50,000
50,000
50,000

UNITS
UNITS
UNITS
UNITS

BASE
BASE
BASE
BASE

A083311
A083321
A083948
A083981

001
001
001
001

EQ 50,000 UNITS BASE

A080921

001

EQ 50,000 UNITS BASE/ML

A080819

001

2MG
5MG
10MG
25MG

N011771
N011771
N011771
N011771

007
004
005
006

50MG/VIAL
75MG/VIAL

N009218
N009218

020
012

5MG
10MG
25MG

N011771
N011771
N011771

003
002
001

VITAMIN A PALMITATE
CAPSULE; ORAL
AFAXIN
STERLING WINTHROP
ALPHALIN
LILLY
DEL-VI-A
DEL RAY LABS
VI-DOM-A
BAYER PHARMS
VITAMIN A
BANNER PHARMACAPS
BRISTOL MYERS SQUIBB
CHASE CHEM
ELKINS SINN
EVERYLIFE
IMPAX LABS
IVAX SUB TEVA PHARMS
MK LABS
WEST WARD
WHARTON LABS
VITAMIN A PALMITATE
ARCUM
BANNER PHARMACAPS
VITAMIN A SOLUBILIZED
TEVA
INJECTABLE; INJECTION
VITAMIN A PALMITATE
BEL MAR

WARFARIN POTASSIUM
TABLET; ORAL
ATHROMBIN-K
PHARM RES ASSOC

WARFARIN SODIUM
INJECTABLE; INJECTION
COUMADIN
BRISTOL MYERS SQUIBB
TABLET; ORAL
ATHROMBIN
PHARM RES ASSOC

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6 - 344 (of 346)

WARFARIN SODIUM
TABLET; ORAL
PANWARFIN
ABBOTT

WARFARIN SODIUM
SANDOZ

USL PHARMA

WATSON LABS

2MG
2.5MG
5MG
7.5MG
10MG

N017020
N017020
N017020
N017020
N017020

001
002
003
004
005

1MG
2MG
2.5MG
3MG
4MG
5MG
6MG
7.5MG
10MG
2MG
2.5MG
5MG
2MG
2.5MG
5MG
7.5MG
10MG

A040196
A040196
A040196
A040196
A040196
A040196
A040196
A040196
A040196
A088719
A088720
A088721
A086123
A086120
A086119
A086118
A086122

001
002
003
008
004
005
009
006
007
001
001
001
001
001
001
001
001

Sep
Sep
Sep
Jul
Sep
Sep
Jul
Sep
Sep
Jun
Aug
Jul
Aug
Aug
Aug
Aug
Aug

5mCi/VIAL
10mCi/VIAL

N018536
N018536

001
002

Oct 01, 1982

Oct 01, 1982

1 CI/AMP
10mCi/VIAL
20mCi/VIAL
5-100 CI/CYLINDER
0.25-5 CI/AMP
10mCi/VIAL
20mCi/VIAL

N017256
N017687
N017687
N017550
N017550
N018327
N018327

002
002
003
001
003
001
002

Mar 09, 1982

Mar 09, 1982

N017687

001

N017256
N017283

001
001

N017262

002

25GM/BOT

N017605

001

25GM/BOT

N018856

001

30,
30,
30,
26,
30,
30,
26,
30,
30,
27,
06,
02,
17,
17,
17,
17,
17,

1997
1997
1997
2000
1997
1997
2000
1997
1997
1985
1985
1985
1982
1982
1982
1982
1982

XENON XE-127
GAS; INHALATION
XENON XE 127
MALLINCKRODT

XENON XE-133
GAS; INHALATION
XENON XE 133
GE HEALTHCARE

GEN ELECTRIC
MALLINCKRODT

XENON XE 133-V.S.S.
GE HEALTHCARE
10mCi/VIAL
INJECTABLE; INJECTION
XENON XE 133
GE HEALTHCARE
1.3-1.7 CI/AMP
LANTHEUS MEDCL
6.3mCi/ML
SOLUTION; INHALATION, INJECTION
XENEISOL
MALLINCKRODT
18-25mCi/AMP

XYLOSE
POWDER; ORAL
XYLO-PFAN
SAVAGE LABS
XYLOSE
LYNE

Mar 26, 1987

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6 - 345 (of 346)

ZALCITABINE
TABLET; ORAL
HIVID
ROCHE

0.375MG
0.75MG

N020199
N020199

001
002

Jun 19, 1992

Jun 19, 1992

5MG
10MG

A078095
A078095

001
002

Jun 06, 2008

Jun 06, 2008

200MCG/2ML (100MCG/ML)

N021060

003

Dec 28, 2004

200MG

N020518

001

Dec 19, 1995

60MG
100MG

N022294
N200732

001
001

Jul 23, 2009

Feb 23, 2011

300MG

N020471

001

Dec 09, 1996

EQ 1MG ZINC/ML

N019229

002

May 05, 1987

N021223

001

Aug 20, 2001

A077288
A077288
A077540
A077540
A076062
A076062

001
002
001
002
001
002

Apr
Apr
Apr
Apr
Apr
Apr

N021412
N021412

001
002

Apr 25, 2007

Apr 25, 2007

A077635
A077635
A077635
A077648
A077648
A077648

001
002
003
001
002
003

Dec
Dec
Dec
Dec
Dec
Dec

ZALEPLON
CAPSULE; ORAL
ZALEPLON
SANDOZ

ZICONOTIDE
INJECTABLE; INTRATHECAL
PRIALT
AZUR PHARMA II

ZIDOVUDINE
TABLET; ORAL
RETROVIR
VIIV HLTHCARE
ZIDOVUDINE
AUROBINDO PHARMA
MATRIX LABS LTD

ZILEUTON
TABLET; ORAL
ZYFLO
CORNERSTONE THERAP

ZINC SULFATE
INJECTABLE; INJECTION
ZINC SULFATE
ABRAXIS PHARM

ZOLEDRONIC ACID
INJECTABLE; IV (INFUSION)
ZOMETA
NOVARTIS
EQ 4MG BASE/VIAL

ZOLPIDEM TARTRATE
TABLET; ORAL
ZOLPIDEM TARTRATE
MUTUAL PHARMA

5MG
10MG
SYNTHON PHARMS
5MG
10MG
WORLD GEN
5MG
10MG
TABLET, ORALLY DISINTEGRATING; ORAL
TOVALT ODT
BIOVAIL LABS INTL
5MG
10MG

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

2007
2007
2007
2007
2007
2007

ZONISAMIDE
CAPSULE; ORAL
ZONISAMIDE
MUTUAL PHARM

ROXANE

25MG
50MG
100MG
25MG
50MG
100MG

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

2005
2005
2005
2005
2005
2005

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DISCONTINUED DRUG PRODUCT LIST

6 - 346 (of 346)

ZONISAMIDE
CAPSULE; ORAL
ZONISAMIDE
TEVA PHARMS

WATSON LABS

25MG
50MG
100MG
25MG
50MG
100MG

A077641
A077641
A077641
A077650
A077650
A077650

003
002
001
001
002
003

Dec
Dec
Dec
Apr
Apr
Apr

22,
22,
22,
20,
20,
20,

2005
2005
2005
2006
2006
2006

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

7-1

ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST

The list of List of Orphan Designations and Approvals is available at:

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/def

ault.htm

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

8-1

DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY

ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION

ACETAMINOPHEN; ASPIRIN;
BUTALBITAL
CAPSULE OR TABLET; ORAL
160-165MG; 160-165MG; 50MG

ASPIRIN; CAFFEINE;
CARISOPRODOL
TABLET; ORAL
160MG; 32MG; 200MG

ACETAMINOPHEN; ASPIRIN;
BUTALBITAL
CAPSULE OR TABLET; ORAL
325MG; 325MG; 50MG

ASPIRIN; CAFFEINE;
CARISOPRODOL;
CODEINE PHOSPHATE
TABLET; ORAL
160MG; 32MG;
200MG; 16MG

ACETAMINOPHEN; ASPIRIN;
BUTALBITAL; CAFFEINE
CAPSULE OR TABLET; ORAL
160-165MG; 160-165MG; 50MG; 40MG
ACETAMINOPHEN; ASPIRIN;
BUTALBITAL; CAFFEINE
CAPSULE OR TABLET; ORAL
325MG; 325MG; 50MG; 40MG
ACETAMINOPHEN; BUTALBITAL
CAPSULE OR TABLET; ORAL
325MG; 50MG
650MG; 50MG

ASPIRIN;
CARISOPRODOL
TABLET; ORAL
325MG; 200MG
ASPIRIN;
CARISOPRODOL;
CODEINE PHOSPHATE
TABLET; ORAL
325MG; 200MG; 16MG
ASPIRIN; MEPROBAMATE
TABLET; ORAL
325MG; 200MG

ACETAMINOPHEN; BUTALBITAL;
CAFFEINE
CAPSULE OR TABLET; ORAL
325MG; 50MG; 40MG
650MG; 50MG; 40MG
500MG; 50MG; 40MG

ASPIRIN;
METHOCARBAMOL
TABLET; ORAL
325MG; 400MG

AMINOPHYLLINE
TABLET; ORAL
100MG; 200MG

CHLOROTHIAZIDE
TABLET; ORAL
250MG

ASPIRIN; BUTALBITAL
CAPSULE OR TABLET; ORAL
325MG; 50MG
650MG; 50MG

HYDROXYZINE
HYDROCHLORIDE
TABLET; ORAL
10MG; 25MG;
50MG; 100MG

ASPIRIN; BUTALBITAL; CAFFEINE

CAPSULE OR TABLET; ORAL
325MG; 50MG; 40MG
650MG; 50MG; 40MG

PREDNISONE
TABLET; ORAL
1MG; 2.5MG;
5MG; 10MG;
20MG; 25MG; 50MG

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, AMOXICILLIN

**

**

**

**

8-MOP, METHOXSALEN

ABELCET, AMPHOTERICIN B
ABILIFY, ARIPIPRAZOLE
ABLAVAR, GADOFOSVESET TRISODIUM
ABRAXANE, PACLITAXEL
ABREVA, DOCOSANOL (OTC)
ABSTRAL, FENTANYL CITRATE
ACANYA, BENZOYL PEROXIDE
ACARBOSE, ACARBOSE
ACCOLATE, ZAFIRLUKAST
ACCUNEB, ALBUTEROL SULFATE
ACCUPRIL, QUINAPRIL HYDROCHLORIDE
ACCURETIC, HYDROCHLOROTHIAZIDE
ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE
ACEON, PERINDOPRIL ERBUMINE
ACEPHEN, ACETAMINOPHEN (OTC)
ACETADOTE, ACETYLCYSTEINE
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC)
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN
ACETASOL HC, ACETIC ACID, GLACIAL
ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM
ACETAZOLAMIDE, ACETAZOLAMIDE
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE, ACETIC ACID, GLACIAL
ACETIC ACID, ACETIC ACID, GLACIAL
ACETOHEXAMIDE, ACETOHEXAMIDE
ACETYLCYSTEINE, ACETYLCYSTEINE
ACIPHEX, RABEPRAZOLE SODIUM
ACLOVATE, ALCLOMETASONE DIPROPIONATE
ACTHREL, CORTICORELIN OVINE TRIFLUTATE
ACTIGALL, URSODIOL
ACTIQ, FENTANYL CITRATE
ACTIVELLA, ESTRADIOL
ACTONEL, RISEDRONATE SODIUM
ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE
ACTOPLUS MET, METFORMIN HYDROCHLORIDE
ACTOS, PIOGLITAZONE HYDROCHLORIDE
ACULAR LS, KETOROLAC TROMETHAMINE
ACULAR PRESERVATIVE FREE, KETOROLAC TROMETHAMINE
ACULAR, KETOROLAC TROMETHAMINE
ACUVAIL, KETOROLAC TROMETHAMINE
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM
ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
ACYCLOVIR, ACYCLOVIR
ACZONE, DAPSONE
ADAGEN, PEGADEMASE BOVINE
ADALAT CC, NIFEDIPINE
ADAPALENE, ADAPALENE
ADCIRCA, TADALAFIL
ADDERALL XR 10, AMPHETAMINE ASPARTATE
ADDERALL XR 15, AMPHETAMINE ASPARTATE
ADDERALL XR 20, AMPHETAMINE ASPARTATE
ADDERALL XR 25, AMPHETAMINE ASPARTATE
ADDERALL XR 30, AMPHETAMINE ASPARTATE

A - 1

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ADDERALL XR 5, AMPHETAMINE ASPARTATE

ADENOCARD, ADENOSINE
ADENOSCAN, ADENOSINE
ADENOSINE, ADENOSINE
ADIPEX-P, PHENTERMINE HYDROCHLORIDE
ADRENACLICK, EPINEPHRINE
ADREVIEW, IOBENGUANE SULFATE I-123
ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE
ADVAIR HFA, FLUTICASONE PROPIONATE
ADVICOR, LOVASTATIN
ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE
ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
ADVIL COLD AND SINUS, IBUPROFEN (OTC)
ADVIL CONGESTION RELIEF, IBUPROFEN (OTC)
ADVIL LIQUI-GELS, IBUPROFEN (OTC)
ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC)
ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)
ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
ADVIL, IBUPROFEN (OTC)
AEROBID, FLUNISOLIDE
AEROSPAN HFA, FLUNISOLIDE
AFEDITAB CR, NIFEDIPINE
AFINITOR, EVEROLIMUS
AFRINOL, PSEUDOEPHEDRINE SULFATE (OTC)
AGGRASTAT, TIROFIBAN HYDROCHLORIDE
AGGRENOX, ASPIRIN
AGRYLIN, ANAGRELIDE HYDROCHLORIDE
A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE
AKBETA, LEVOBUNOLOL HYDROCHLORIDE
AK-FLUOR 10%, FLUORESCEIN SODIUM
AKINETON, BIPERIDEN HYDROCHLORIDE
AKNE-MYCIN, ERYTHROMYCIN
AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE
AKPRO, DIPIVEFRIN HYDROCHLORIDE
AKTEN, LIDOCAINE HYDROCHLORIDE
AKTOB, TOBRAMYCIN
ALA-CORT, HYDROCORTISONE
ALAMAST, PEMIROLAST POTASSIUM
ALA-SCALP, HYDROCORTISONE
ALAVERT, LORATADINE (OTC)
ALAWAY, KETOTIFEN FUMARATE (OTC)
ALBALON, NAPHAZOLINE HYDROCHLORIDE
ALBENZA, ALBENDAZOLE
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALCAINE, PROPARACAINE HYDROCHLORIDE
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
ALCOHOL 10% AND DEXTROSE 5%, ALCOHOL
ALCOHOL 5% AND DEXTROSE 5%, ALCOHOL
ALDACTAZIDE, HYDROCHLOROTHIAZIDE
ALDACTONE, SPIRONOLACTONE
ALDARA, IMIQUIMOD
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALEVE, NAPROXEN SODIUM (OTC)
ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)
ALFENTA, ALFENTANIL HYDROCHLORIDE
ALFENTANIL, ALFENTANIL HYDROCHLORIDE
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALIMTA, PEMETREXED DISODIUM
ALINIA, NITAZOXANIDE
ALKERAN, MELPHALAN

(OTC)

A - 2

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ALKERAN, MELPHALAN HYDROCHLORIDE

ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLEGRA, FEXOFENADINE HYDROCHLORIDE
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLI, ORLISTAT (OTC)
ALLOPURINOL SODIUM, ALLOPURINOL SODIUM
ALLOPURINOL, ALLOPURINOL
ALOCRIL, NEDOCROMIL SODIUM
ALOMIDE, LODOXAMIDE TROMETHAMINE
ALOPRIM, ALLOPURINOL SODIUM
ALORA, ESTRADIOL
ALOXI, PALONOSETRON HYDROCHLORIDE
ALPHAGAN P, BRIMONIDINE TARTRATE
ALPRAZOLAM, ALPRAZOLAM
ALPROSTADIL, ALPROSTADIL
ALREX, LOTEPREDNOL ETABONATE
ALSUMA, SUMATRIPTAN SUCCINATE
ALTABAX, RETAPAMULIN
ALTACE, RAMIPRIL
ALTAVERA, ETHINYL ESTRADIOL
ALTOPREV, LOVASTATIN
ALVESCO, CICLESONIDE
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMARYL, GLIMEPIRIDE
AMBIEN CR, ZOLPIDEM TARTRATE
AMBIEN, ZOLPIDEM TARTRATE
AMBISOME, AMPHOTERICIN B
AMCINONIDE, AMCINONIDE
AMERGE, NARATRIPTAN HYDROCHLORIDE
A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE
AMICAR, AMINOCAPROIC ACID
AMIDATE, ETOMIDATE
AMIFOSTINE, AMIFOSTINE
AMIKACIN SULFATE, AMIKACIN SULFATE
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE
AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE
AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID
AMINOCAPROIC ACID, AMINOCAPROIC ACID
AMINOCAPROIC, AMINOCAPROIC ACID
AMINOHIPPURATE SODIUM, AMINOHIPPURATE SODIUM
AMINOPHYLLINE, AMINOPHYLLINE
AMINOSYN 10% (PH6), AMINO ACIDS
AMINOSYN 10%, AMINO ACIDS
AMINOSYN 3.5% M, AMINO ACIDS
AMINOSYN 3.5%, AMINO ACIDS
AMINOSYN 5%, AMINO ACIDS
AMINOSYN 7% (PH6), AMINO ACIDS
AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN 7%, AMINO ACIDS
AMINOSYN 8.5% (PH6), AMINO ACIDS
AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN 8.5%, AMINO ACIDS
AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 10%, AMINO ACIDS
AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 7%, AMINO ACIDS
AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 8.5%, AMINO ACIDS
AMINOSYN-HBC 7%, AMINO ACIDS

A - 3

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

AMINOSYN-HF 8%, AMINO ACIDS

AMINOSYN-PF 10%, AMINO ACIDS
AMINOSYN-PF 7%, AMINO ACIDS
AMINOSYN-RF 5.2%, AMINO ACIDS
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMITIZA, LUBIPROSTONE
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMMONIA N 13, AMMONIA, N-13
AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE
AMMONIUM LACTATE, AMMONIUM LACTATE
AMMONUL, SODIUM BENZOATE
AMNESTEEM, ISOTRETINOIN
AMOXAPINE, AMOXAPINE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN PEDIATRIC, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
AMOXIL, AMOXICILLIN
AMPHADASE, HYALURONIDASE
AMPHOTEC, AMPHOTERICIN B
AMPHOTERICIN B, AMPHOTERICIN B
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE
AMPYRA, DALFAMPRIDINE
AMRINONE LACTATE, INAMRINONE LACTATE
AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE
AMTURNIDE, ALISKIREN HEMIFUMARATE
ANADROL-50, OXYMETHOLONE
ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
ANAPROX DS, NAPROXEN SODIUM
ANAPROX, NAPROXEN SODIUM
ANASTROZOLE, ANASTROZOLE
ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM
ANCOBON, FLUCYTOSINE
ANDRODERM, TESTOSTERONE
ANDROGEL, TESTOSTERONE
ANDROID 10, METHYLTESTOSTERONE
ANDROID 25, METHYLTESTOSTERONE
AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT
ANECTINE, SUCCINYLCHOLINE CHLORIDE
ANESTACON, LIDOCAINE HYDROCHLORIDE
ANEXSIA 5/325, ACETAMINOPHEN
ANEXSIA 7.5/325, ACETAMINOPHEN
ANEXSIA 7.5/650, ACETAMINOPHEN
ANEXSIA, ACETAMINOPHEN
ANGELIQ, DROSPIRENONE
ANGIOMAX, BIVALIRUDIN
ANSAID, FLURBIPROFEN
AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT
ANTABUSE, DISULFIRAM
ANTARA (MICRONIZED), FENOFIBRATE
ANTHELIOS 20, AVOBENZONE (OTC)
ANTHELIOS 40, AVOBENZONE (OTC)
ANTHELIOS SX, AVOBENZONE (OTC)
ANTIVERT, MECLIZINE HYDROCHLORIDE
ANTIZOL, FOMEPIZOLE
ANTUROL, OXYBUTYNIN
ANUSOL HC, HYDROCORTISONE
ANZEMET, DOLASETRON MESYLATE
APHTHASOL, AMLEXANOX

A - 4

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT

APIDRA, INSULIN GLULISINE RECOMBINANT
APLENZIN, BUPROPION HYDROBROMIDE
APOKYN, APOMORPHINE HYDROCHLORIDE
APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE
APRISO, MESALAMINE
APTIVUS, TIPRANAVIR
AQUASOL A, VITAMIN A PALMITATE
ARALEN, CHLOROQUINE PHOSPHATE
ARANELLE, ETHINYL ESTRADIOL
ARAVA, LEFLUNOMIDE
ARCAPTA NEOHALER, INDACATEROL MALEATE
AREDIA, PAMIDRONATE DISODIUM
ARESTIN, MINOCYCLINE HYDROCHLORIDE
ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN
ARGATROBAN, ARGATROBAN
ARICEPT ODT, DONEPEZIL HYDROCHLORIDE
ARICEPT, DONEPEZIL HYDROCHLORIDE
ARIDOL KIT, MANNITOL
ARIMIDEX, ANASTROZOLE
ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE
ARIXTRA, FONDAPARINUX SODIUM
AROMASIN, EXEMESTANE
ARRANON, NELARABINE
ARTHROTEC, DICLOFENAC SODIUM
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE
ARTICAINE HYDROCHLORIDE WITH EPINEPHRINE, ARTICAINE HYDROCHLORIDE
ASACOL HD, MESALAMINE
ASACOL, MESALAMINE
ASCLERA, POLIDOCANOL
ASMANEX TWISTHALER, MOMETASONE FUROATE
ASPIRIN AND DIPYRIDAMOLE, ASPIRIN
ASTELIN, AZELASTINE HYDROCHLORIDE
ASTEPRO, AZELASTINE HYDROCHLORIDE
ASTRAMORPH PF, MORPHINE SULFATE
ATACAND HCT, CANDESARTAN CILEXETIL
ATACAND, CANDESARTAN CILEXETIL
ATELVIA, RISEDRONATE SODIUM
ATENOLOL AND CHLORTHALIDONE, ATENOLOL
ATENOLOL, ATENOLOL
ATIVAN, LORAZEPAM
ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE
ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE
ATRACURIUM BESYLATE, ATRACURIUM BESYLATE
ATRALIN, TRETINOIN
ATRIDOX, DOXYCYCLINE HYCLATE
ATRIPLA, EFAVIRENZ
ATROPEN, ATROPINE
ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE
ATROVENT HFA, IPRATROPIUM BROMIDE
ATROVENT, IPRATROPIUM BROMIDE
AUGMENTIN '125', AMOXICILLIN
AUGMENTIN '200', AMOXICILLIN
AUGMENTIN '250', AMOXICILLIN
AUGMENTIN '400', AMOXICILLIN
AUGMENTIN '500', AMOXICILLIN
AUGMENTIN '875', AMOXICILLIN
AUGMENTIN ES-600, AMOXICILLIN
AUGMENTIN XR, AMOXICILLIN
AVAGARD, ALCOHOL (OTC)
AVAGE, TAZAROTENE

A - 5

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

AVALIDE, HYDROCHLOROTHIAZIDE
AVANDAMET, METFORMIN HYDROCHLORIDE
AVANDARYL, GLIMEPIRIDE
AVANDIA, ROSIGLITAZONE MALEATE
AVAPRO, IRBESARTAN
AVC, SULFANILAMIDE
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE
AVELOX, MOXIFLOXACIN HYDROCHLORIDE
AVENTYL HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
AVIANE-28, ETHINYL ESTRADIOL
AVINZA, MORPHINE SULFATE
AVITA, TRETINOIN
AVODART, DUTASTERIDE
AXERT, ALMOTRIPTAN MALATE
AXID AR, NIZATIDINE (OTC)
AXID, NIZATIDINE
AXIRON, TESTOSTERONE
AYGESTIN, NORETHINDRONE ACETATE
AZACTAM IN PLASTIC CONTAINER, AZTREONAM
AZACTAM, AZTREONAM
AZASAN, AZATHIOPRINE
AZASITE, AZITHROMYCIN
AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM
AZATHIOPRINE, AZATHIOPRINE
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
AZELEX, AZELAIC ACID
AZILECT, RASAGILINE MESYLATE
AZITHROMYCIN, AZITHROMYCIN
AZMACORT, TRIAMCINOLONE ACETONIDE
AZOPT, BRINZOLAMIDE
AZOR, AMLODIPINE BESYLATE
AZTREONAM, AZTREONAM
AZULFIDINE EN-TABS, SULFASALAZINE
AZULFIDINE, SULFASALAZINE

**

**

BACIIM, BACITRACIN
BACI-RX, BACITRACIN
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BACITRACIN, BACITRACIN
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN
BACLOFEN, BACLOFEN
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM
BACTRIM DS, SULFAMETHOXAZOLE
BACTRIM, SULFAMETHOXAZOLE
BACTROBAN, MUPIROCIN
BACTROBAN, MUPIROCIN CALCIUM
BAL, DIMERCAPROL
BALANCED SALT, CALCIUM CHLORIDE
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BALZIVA-28, ETHINYL ESTRADIOL
BANZEL, RUFINAMIDE
BARACLUDE, ENTECAVIR
BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE
BENADRYL PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE
BENADRYL, DIPHENHYDRAMINE HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BENICAR HCT, HYDROCHLOROTHIAZIDE
BENICAR, OLMESARTAN MEDOXOMIL
BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE

A - 6

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

BENTYL, DICYCLOMINE HYDROCHLORIDE

BENZACLIN, BENZOYL PEROXIDE
BENZAMYCIN PAK, BENZOYL PEROXIDE
BENZAMYCIN, BENZOYL PEROXIDE
BENZONATATE, BENZONATATE
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BEPREVE, BEPOTASTINE BESILATE
BESIVANCE, BESIFLOXACIN HYDROCHLORIDE
BETADINE, POVIDONE-IODINE
BETAGAN, LEVOBUNOLOL HYDROCHLORIDE
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
BETAPACE AF, SOTALOL HYDROCHLORIDE
BETAPACE, SOTALOL HYDROCHLORIDE
BETA-VAL, BETAMETHASONE VALERATE
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
BETIMOL, TIMOLOL
BETOPTIC S, BETAXOLOL HYDROCHLORIDE
BETOPTIC, BETAXOLOL HYDROCHLORIDE
BEYAZ, DROSPIRENONE
BIAXIN XL, CLARITHROMYCIN
BIAXIN, CLARITHROMYCIN
BICALUTAMIDE, BICALUTAMIDE
BICILLIN C-R 900/300, PENICILLIN G BENZATHINE
BICILLIN C-R, PENICILLIN G BENZATHINE
BICILLIN L-A, PENICILLIN G BENZATHINE
BICNU, CARMUSTINE
BIDIL, HYDRALAZINE HYDROCHLORIDE
BILTRICIDE, PRAZIQUANTEL
BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC)
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BLEPH-10, SULFACETAMIDE SODIUM
BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE
BLEPHAMIDE, PREDNISOLONE ACETATE
BONIVA, IBANDRONATE SODIUM
BONTRIL PDM, PHENDIMETRAZINE TARTRATE
BONTRIL, PHENDIMETRAZINE TARTRATE
BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS
BRAVELLE, UROFOLLITROPIN
BREATHTEK UBT FOR H-PYLORI, UREA C-13
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC, ESMOLOL HYDROCHLORIDE
BREVICON 28-DAY, ETHINYL ESTRADIOL
BREVITAL SODIUM, METHOHEXITAL SODIUM
BRIAN CARE, CHLORHEXIDINE GLUCONATE (OTC)
BRIELLYN, ETHINYL ESTRADIOL
BRILINTA, TICAGRELOR
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
BROMDAY, BROMFENAC SODIUM
BROMFED-DM, BROMPHENIRAMINE MALEATE
BROMFENAC SODIUM, BROMFENAC SODIUM
BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
BRONCHO SALINE, SODIUM CHLORIDE (OTC)
BROVANA, ARFORMOTEROL TARTRATE
BSS PLUS, CALCIUM CHLORIDE
BSS, CALCIUM CHLORIDE

A - 7

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

A - 8

PRODUCT NAME INDEX

**

**

BUDESONIDE, BUDESONIDE
BUMETANIDE, BUMETANIDE
BUPHENYL, SODIUM PHENYLBUTYRATE
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
BUPRENEX, BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
BUSULFEX, BUSULFAN
BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN
BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN
BUTAPAP, ACETAMINOPHEN
BUTISOL SODIUM, BUTABARBITAL SODIUM
BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
BUTRANS, BUPRENORPHINE
BYETTA, EXENATIDE SYNTHETIC
BYSTOLIC, NEBIVOLOL HYDROCHLORIDE

**

**

CABERGOLINE, CABERGOLINE
CADUET, AMLODIPINE BESYLATE
CAFCIT, CAFFEINE CITRATE
CAFERGOT, CAFFEINE
CAFFEINE CITRATE, CAFFEINE CITRATE
CALAN, VERAPAMIL HYDROCHLORIDE
CALCIJEX, CALCITRIOL
CALCIPOTRIENE, CALCIPOTRIENE
CALCITONIN-SALMON, CALCITONIN SALMON
CALCITRIOL, CALCITRIOL
CALCIUM ACETATE, CALCIUM ACETATE
CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM
CALDOLOR, IBUPROFEN
CAMBIA, DICLOFENAC POTASSIUM
CAMILA, NORETHINDRONE
CAMPRAL, ACAMPROSATE CALCIUM
CAMPTOSAR, IRINOTECAN HYDROCHLORIDE
CANASA, MESALAMINE
CANCIDAS, CASPOFUNGIN ACETATE
CANTIL, MEPENZOLATE BROMIDE
CAPASTAT SULFATE, CAPREOMYCIN SULFATE
CAPEX, FLUOCINOLONE ACETONIDE
CAPITAL AND CODEINE, ACETAMINOPHEN
CAPITAL SOLEIL 15, AVOBENZONE (OTC)
CAPOTEN, CAPTOPRIL
CAPOZIDE 25/15, CAPTOPRIL
CAPOZIDE 25/25, CAPTOPRIL
CAPOZIDE 50/15, CAPTOPRIL
CAPOZIDE 50/25, CAPTOPRIL
CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL
CAPTOPRIL, CAPTOPRIL
CARAC, FLUOROURACIL
CARAFATE, SUCRALFATE
CARBAGLU, CARGLUMIC ACID
CARBAMAZEPINE, CARBAMAZEPINE

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

CARBATROL, CARBAMAZEPINE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CARBOCAINE, MEPIVACAINE HYDROCHLORIDE
CARBOPLATIN, CARBOPLATIN
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE SR, NICARDIPINE HYDROCHLORIDE
CARDENE, NICARDIPINE HYDROCHLORIDE
CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82
CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT
CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CARDIZEM CD, DILTIAZEM HYDROCHLORIDE
CARDIZEM LA, DILTIAZEM HYDROCHLORIDE
CARDIZEM, DILTIAZEM HYDROCHLORIDE
CARDURA XL, DOXAZOSIN MESYLATE
CARDURA, DOXAZOSIN MESYLATE
CARISOPRODOL AND ASPIRIN, ASPIRIN
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN
CARISOPRODOL, CARISOPRODOL
CARMOL HC, HYDROCORTISONE ACETATE
CARNITOR SF, LEVOCARNITINE
CARNITOR, LEVOCARNITINE
CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE
CARTIA XT, DILTIAZEM HYDROCHLORIDE
CARVEDILOL, CARVEDILOL
CASODEX, BICALUTAMIDE
CATAFLAM, DICLOFENAC POTASSIUM
CATAPRES, CLONIDINE HYDROCHLORIDE
CATAPRES-TTS-1, CLONIDINE
CATAPRES-TTS-2, CLONIDINE
CATAPRES-TTS-3, CLONIDINE
CAVERJECT IMPULSE, ALPROSTADIL
CAVERJECT, ALPROSTADIL
CAYSTON, AZTREONAM
CEDAX, CEFTIBUTEN DIHYDRATE
CEENU, LOMUSTINE
CEFACLOR, CEFACLOR
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFDINIR, CEFDINIR
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE
CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE
CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFOTAXIME, CEFOTAXIME SODIUM
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM
CEFOTETAN, CEFOTETAN DISODIUM
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM
CEFOXITIN, CEFOXITIN
CEFOXITIN, CEFOXITIN SODIUM
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME
CEFTAZIDIME, CEFTAZIDIME
CEFTIN, CEFUROXIME AXETIL
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM
CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM

A - 9

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

A - 10

**

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEFUROXIME SODIUM IN PLASTIC CONTAINER, CEFUROXIME SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM
CELEBREX, CELECOXIB
CELESTONE SOLUSPAN, BETAMETHASONE ACETATE
CELESTONE, BETAMETHASONE
CELEXA, CITALOPRAM HYDROBROMIDE
CELLCEPT, MYCOPHENOLATE MOFETIL
CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE
CELONTIN, METHSUXIMIDE
CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A
CENTANY, MUPIROCIN
CEPHALEXIN, CEPHALEXIN
CEREDASE, ALGLUCERASE
CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT
CEREZYME, IMIGLUCERASE
CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE
CERVIDIL, DINOPROSTONE
CESAMET, NABILONE
CETAMIDE, SULFACETAMIDE SODIUM
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE
CETROTIDE, CETRORELIX
CEVIMELINE, CEVIMELINE HYDROCHLORIDE
CHANTIX, VARENICLINE TARTRATE
CHEMET, SUCCIMER
CHENODIOL, CHENODIOL
CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC)
CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)
CHILDREN'S ADVIL, IBUPROFEN (OTC)
CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC)
CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CLARITIN, LORATADINE (OTC)
CHILDREN'S ELIXSURE, IBUPROFEN (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S IBUPROFEN, IBUPROFEN (OTC)
CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC)
CHILDREN'S MOTRIN, IBUPROFEN (OTC)
CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN
CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE
CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)
CHLORASCRUB MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORASCRUB SWAB, CHLORHEXIDINE GLUCONATE (OTC)
CHLORASCRUB SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)

CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
CHLOROTHIAZIDE, CHLOROTHIAZIDE
CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC)
CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE
CHLORPROPAMIDE, CHLORPROPAMIDE
CHLORTHALIDONE, CHLORTHALIDONE
CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC)
CHLORZOXAZONE, CHLORZOXAZONE
CHOLAC, LACTULOSE
CHOLEDYL SA, OXTRIPHYLLINE
CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE
CHOLESTYRAMINE, CHOLESTYRAMINE
CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT
CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE
CHROMITOPE SODIUM, SODIUM CHROMATE CR-51
CIALIS, TADALAFIL
CICLOPIROX, CICLOPIROX
CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC)
CILOSTAZOL, CILOSTAZOL
CILOXAN, CIPROFLOXACIN HYDROCHLORIDE
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CIMETIDINE, CIMETIDINE
CIMETIDINE, CIMETIDINE (OTC)
CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPRO XR, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN HYDROCHLORIDE
CIPRODEX, CIPROFLOXACIN
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT
CISPLATIN, CISPLATIN
CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE
CITANEST PLAIN DENTAL, PRILOCAINE HYDROCHLORIDE
CLADRIBINE, CLADRIBINE
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM
CLAFORAN, CEFOTAXIME SODIUM
CLARAVIS, ISOTRETINOIN
CLARINEX D 24 HOUR, DESLORATADINE
CLARINEX, DESLORATADINE
CLARINEX-D 12 HOUR, DESLORATADINE
CLARITHROMYCIN, CLARITHROMYCIN
CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC)
CLARITIN HIVES RELIEF, LORATADINE (OTC)
CLARITIN REDITABS, LORATADINE (OTC)
CLARITIN, LORATADINE (OTC)
CLARITIN-D 24 HOUR, LORATADINE (OTC)
CLARITIN-D, LORATADINE (OTC)
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC)
CLENZ-LYTE, POLYETHYLENE GLYCOL 3350
CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

A - 11

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

A - 12

**

CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLEOCIN T, CLINDAMYCIN PHOSPHATE
CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLEOCIN, CLINDAMYCIN PHOSPHATE
CLEVIPREX, CLEVIDIPINE BUTYRATE
CLIMARA PRO, ESTRADIOL
CLIMARA, ESTRADIOL
CLINDA-DERM, CLINDAMYCIN PHOSPHATE
CLINDAGEL, CLINDAMYCIN PHOSPHATE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLINDESSE, CLINDAMYCIN PHOSPHATE
CLINDETS, CLINDAMYCIN PHOSPHATE
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER, AMINO
ACIDS
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
CLINORIL, SULINDAC
CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOBEX, CLOBETASOL PROPIONATE
CLODERM, CLOCORTOLONE PIVALATE
CLOLAR, CLOFARABINE
CLOMID, CLOMIPHENE CITRATE
CLOMIPHENE CITRATE, CLOMIPHENE CITRATE
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CLONIDINE, CLONIDINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

CLORPRES, CHLORTHALIDONE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)
CLOZAPINE, CLOZAPINE
CLOZARIL, CLOZAPINE
COARTEM, ARTEMETHER
CODEINE SULFATE, CODEINE SULFATE
COGENTIN, BENZTROPINE MESYLATE
CO-GESIC, ACETAMINOPHEN
COLAZAL, BALSALAZIDE DISODIUM
COLCRYS, COLCHICINE
COLESTID, COLESTIPOL HYDROCHLORIDE
COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE
COLGATE TOTAL, SODIUM FLUORIDE (OTC)
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
COLOCORT, HYDROCORTISONE
COL-PROBENECID, COLCHICINE
COLY-MYCIN M, COLISTIMETHATE SODIUM
COLY-MYCIN S, COLISTIN SULFATE
COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
COLYTE, POLYETHYLENE GLYCOL 3350
COLYTE-FLAVORED, POLYETHYLENE GLYCOL 3350
COMBIGAN, BRIMONIDINE TARTRATE
COMBIPATCH, ESTRADIOL
COMBIVENT RESPIMAT, ALBUTEROL SULFATE
COMBIVENT, ALBUTEROL SULFATE
COMBIVIR, LAMIVUDINE
COMMIT, NICOTINE POLACRILEX (OTC)
COMPLERA, EMTRICITABINE
COMPRO, PROCHLORPERAZINE
COMTAN, ENTACAPONE
CONCERTA, METHYLPHENIDATE HYDROCHLORIDE
CONDYLOX, PODOFILOX
CONRAY 30, IOTHALAMATE MEGLUMINE
CONRAY 43, IOTHALAMATE MEGLUMINE
CONRAY, IOTHALAMATE MEGLUMINE
CONSTILAC, LACTULOSE
CONSTULOSE, LACTULOSE
CONZIP, TRAMADOL HYDROCHLORIDE
COPAXONE, GLATIRAMER ACETATE
COPEGUS, RIBAVIRIN
CORDARONE, AMIODARONE HYDROCHLORIDE
CORDRAN SP, FLURANDRENOLIDE
CORDRAN, FLURANDRENOLIDE
COREG CR, CARVEDILOL PHOSPHATE
COREG, CARVEDILOL
CORGARD, NADOLOL
CORLOPAM, FENOLDOPAM MESYLATE
CORMAX, CLOBETASOL PROPIONATE
CORTEF, HYDROCORTISONE
CORTENEMA, HYDROCORTISONE
CORTIFOAM, HYDROCORTISONE ACETATE
CORTISONE ACETATE, CORTISONE ACETATE
CORTISPORIN, BACITRACIN ZINC
CORTISPORIN, HYDROCORTISONE
CORTISPORIN, HYDROCORTISONE ACETATE
CORTROSYN, COSYNTROPIN
CORVERT, IBUTILIDE FUMARATE
CORZIDE, BENDROFLUMETHIAZIDE
COSMEGEN, DACTINOMYCIN
COSOPT, DORZOLAMIDE HYDROCHLORIDE

A - 13

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

COSYNTROPIN, COSYNTROPIN
COUMADIN, WARFARIN SODIUM
COVERA-HS, VERAPAMIL HYDROCHLORIDE
COZAAR, LOSARTAN POTASSIUM
CREON, LIPASE
CRESTOR, ROSUVASTATIN CALCIUM
CRINONE, PROGESTERONE
CRIXIVAN, INDINAVIR SULFATE
CROLOM, CROMOLYN SODIUM
CROMOLYN SODIUM, CROMOLYN SODIUM
CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)
CROTAN, CROTAMITON
CRYSELLE, ETHINYL ESTRADIOL
CUBICIN, DAPTOMYCIN
CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE
CUPRIMINE, PENICILLAMINE
CUROSURF, PORACTANT ALFA
CUTIVATE, FLUTICASONE PROPIONATE
CUVPOSA, GLYCOPYRROLATE
CYANOCOBALAMIN, CYANOCOBALAMIN
CYANOKIT, HYDROXOCOBALAMIN
CYCLAFEM 1/35, ETHINYL ESTRADIOL
CYCLAFEM 7/7/7, ETHINYL ESTRADIOL
CYCLESSA, DESOGESTREL
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE
CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
CYCLOSET, BROMOCRIPTINE MESYLATE
CYCLOSPORINE, CYCLOSPORINE
CYKLOKAPRON, TRANEXAMIC ACID
CYMBALTA, DULOXETINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
CYSTADANE, BETAINE HYDROCHLORIDE
CYSTAGON, CYSTEAMINE BITARTRATE
CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE
CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE
CYSTOGRAFIN, DIATRIZOATE MEGLUMINE
CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE
CYTARABINE, CYTARABINE
CYTOMEL, LIOTHYRONINE SODIUM
CYTOSAR-U, CYTARABINE
CYTOTEC, MISOPROSTOL
CYTOVENE, GANCICLOVIR SODIUM
CYTOXAN, CYCLOPHOSPHAMIDE

**

**

D.H.E. 45, DIHYDROERGOTAMINE MESYLATE

DACARBAZINE, DACARBAZINE
DACOGEN, DECITABINE
DACTINOMYCIN, DACTINOMYCIN
DALIRESP, ROFLUMILAST
DANAZOL, DANAZOL
DANTRIUM, DANTROLENE SODIUM
DANTROLENE SODIUM, DANTROLENE SODIUM
DAPSONE, DAPSONE
DARAPRIM, PYRIMETHAMINE
DASETTA 1/35, ETHINYL ESTRADIOL
DASETTA 7/7/7, ETHINYL ESTRADIOL
DATSCAN, IOFLUPANE I-123
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
DAUNOXOME, DAUNORUBICIN CITRATE
DAYPRO, OXAPROZIN

A - 14

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

A - 15

**

DAYTRANA, METHYLPHENIDATE
DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
DDAVP, DESMOPRESSIN ACETATE
DECLOMYCIN, DEMECLOCYCLINE HYDROCHLORIDE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEFINITY, PERFLUTREN
DELATESTRYL, TESTOSTERONE ENANTHATE
DELESTROGEN, ESTRADIOL VALERATE
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC)
DEMADEX, TORSEMIDE
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DEMSER, METYROSINE
DENAVIR, PENCICLOVIR SODIUM
DENDRID, IDOXURIDINE
DEPACON, VALPROATE SODIUM
DEPAKENE, VALPROIC ACID
DEPAKOTE ER, DIVALPROEX SODIUM
DEPAKOTE, DIVALPROEX SODIUM
DEPEN, PENICILLAMINE
DEPOCYT, CYTARABINE
DEPODUR, MORPHINE SULFATE
DEPO-ESTRADIOL, ESTRADIOL CYPIONATE
DEPO-MEDROL, METHYLPREDNISOLONE ACETATE
DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE
DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE
DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE
DERMABET, BETAMETHASONE VALERATE
DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE
DERMATOP E EMOLLIENT, PREDNICARBATE
DERMATOP, PREDNICARBATE
DERMOTIC, FLUOCINOLONE ACETONIDE
DESFERAL, DEFEROXAMINE MESYLATE
DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE
DESLORATADINE, DESLORATADINE
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DESOGEN, DESOGESTREL
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
DESONATE, DESONIDE
DESONIDE, DESONIDE
DESOWEN, DESONIDE
DESOXIMETASONE, DESOXIMETASONE
DESOXYN, METHAMPHETAMINE HYDROCHLORIDE
DETROL LA, TOLTERODINE TARTRATE
DETROL, TOLTERODINE TARTRATE
DEXAMETHASONE INTENSOL, DEXAMETHASONE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

A - 16

**

DEXAMETHASONE, DEXAMETHASONE
DEXASPORIN, DEXAMETHASONE
DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE
DEXEDRINE, DEXTROAMPHETAMINE SULFATE
DEXFERRUM, IRON DEXTRAN
DEXILANT, DEXLANSOPRAZOLE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE ASPARTATE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 25%, DEXTROSE
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

A - 17

**

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER,
DEXTROSE
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DIABETA, GLYBURIDE
DIABINESE, CHLORPROPAMIDE
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIAMOX, ACETAZOLAMIDE
DIAMOX, ACETAZOLAMIDE SODIUM
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIASTAT ACUDIAL, DIAZEPAM
DIASTAT, DIAZEPAM
DIAZEPAM INTENSOL, DIAZEPAM
DIAZEPAM, DIAZEPAM
DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DIDANOSINE, DIDANOSINE
DIDREX, BENZPHETAMINE HYDROCHLORIDE
DIDRONEL, ETIDRONATE DISODIUM
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
DIFFERIN, ADAPALENE
DIFICID, FIDAXOMICIN
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
DIFLUCAN, FLUCONAZOLE
DIFLUNISAL, DIFLUNISAL
DIGOXIN, DIGOXIN
DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE
DILACOR XR, DILTIAZEM HYDROCHLORIDE
DILANTIN, PHENYTOIN
DILANTIN, PHENYTOIN SODIUM
DILANTIN-125, PHENYTOIN
DILATRATE-SR, ISOSORBIDE DINITRATE
DILAUDID, HYDROMORPHONE HYDROCHLORIDE
DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE
DILT-CD, DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

DILTZAC, DILTIAZEM HYDROCHLORIDE

DIMENHYDRINATE, DIMENHYDRINATE
DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE
DIOVAN HCT, HYDROCHLOROTHIAZIDE
DIOVAN, VALSARTAN
DIPENTUM, OLSALAZINE SODIUM
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DIPIVEFRIN HYDROCHLORIDE, DIPIVEFRIN HYDROCHLORIDE
DIPRIVAN, PROPOFOL
DIPROLENE AF, BETAMETHASONE DIPROPIONATE
DIPROLENE, BETAMETHASONE DIPROPIONATE
DIPYRIDAMOLE, DIPYRIDAMOLE
DISOPHROL, DEXBROMPHENIRAMINE MALEATE (OTC)
DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE
DISPERMOX, AMOXICILLIN
DISULFIRAM, DISULFIRAM
DITROPAN XL, OXYBUTYNIN CHLORIDE
DITROPAN, OXYBUTYNIN CHLORIDE
DIURIL, CHLOROTHIAZIDE
DIURIL, CHLOROTHIAZIDE SODIUM
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DIVIGEL, ESTRADIOL
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%, DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
DOCEFREZ, DOCETAXEL
DOCETAXEL, DOCETAXEL
DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE
DOPRAM, DOXAPRAM HYDROCHLORIDE
DORAL, QUAZEPAM
DORIBAX, DORIPENEM
DORYX, DOXYCYCLINE HYCLATE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
DOVONEX, CALCIPOTRIENE
DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXERCALCIFEROL, DOXERCALCIFEROL
DOXIL, DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
DOXY 100, DOXYCYCLINE HYCLATE
DOXY 200, DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
DOXYCYCLINE, DOXYCYCLINE HYCLATE
DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)
DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE
DRISDOL, ERGOCALCIFEROL
DRIXORAL PLUS, ACETAMINOPHEN (OTC)
DRIXORAL, DEXBROMPHENIRAMINE MALEATE (OTC)
DRONABINOL, DRONABINOL
DROPERIDOL, DROPERIDOL
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
DROXIA, HYDROXYUREA
DTIC-DOME, DACARBAZINE

A - 18

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

**

**

DTPA, TECHNETIUM TC-99M PENTETATE KIT

DUAC, BENZOYL PEROXIDE
DUETACT, GLIMEPIRIDE
DUEXIS, FAMOTIDINE
DULERA, FORMOTEROL FUMARATE
DUODOTE, ATROPINE
DUONEB, ALBUTEROL SULFATE
DURACLON, CLONIDINE HYDROCHLORIDE
DURAGESIC-100, FENTANYL
DURAGESIC-12, FENTANYL
DURAGESIC-25, FENTANYL
DURAGESIC-50, FENTANYL
DURAGESIC-75, FENTANYL
DURAMORPH PF, MORPHINE SULFATE
DURAPREP, IODINE POVACRYLEX (OTC)
DUREZOL, DIFLUPREDNATE
DUTASTERIDE, DUTASTERIDE
DUVOID, BETHANECHOL CHLORIDE
DYAZIDE, HYDROCHLOROTHIAZIDE
DYNACIN, MINOCYCLINE HYDROCHLORIDE
DYNACIRC CR, ISRADIPINE
DYNA-HEX, CHLORHEXIDINE GLUCONATE (OTC)
DYRENIUM, TRIAMTERENE

E.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATE

E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE
E.E.S., ERYTHROMYCIN ETHYLSUCCINATE
EC-NAPROSYN, NAPROXEN
ECONAZOLE NITRATE, ECONAZOLE NITRATE
EDARBI, AZILSARTAN KAMEDOXOMIL
EDARBYCLOR, AZILSARTAN KAMEDOXOMIL
EDECRIN, ETHACRYNATE SODIUM
EDECRIN, ETHACRYNIC ACID
EDEX, ALPROSTADIL
EDLUAR, ZOLPIDEM TARTRATE
EDURANT, RILPIVIRINE HYDROCHLORIDE
EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE
EFFIENT, PRASUGREL HYDROCHLORIDE
EFUDEX, FLUOROURACIL
E-GLADES, ERYTHROMYCIN
EGRIFTA, TESAMORELIN ACETATE
ELDEPRYL, SELEGILINE HYDROCHLORIDE
ELESTAT, EPINASTINE HYDROCHLORIDE
ELESTRIN, ESTRADIOL
ELIDEL, PIMECROLIMUS
ELIGARD, LEUPROLIDE ACETATE
ELIMITE, PERMETHRIN
ELIPHOS, CALCIUM ACETATE
ELIXOPHYLLIN, THEOPHYLLINE
ELLA, ULIPRISTAL ACETATE
ELLENCE, EPIRUBICIN HYDROCHLORIDE
ELLIOTTS B SOLUTION, CALCIUM CHLORIDE
ELMIRON, PENTOSAN POLYSULFATE SODIUM
ELOCON, MOMETASONE FUROATE
ELOXATIN, OXALIPLATIN
EMADINE, EMEDASTINE DIFUMARATE
EMBEDA, MORPHINE SULFATE
EMBELINE E, CLOBETASOL PROPIONATE
EMBELINE, CLOBETASOL PROPIONATE
EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM
EMEND, APREPITANT
EMEND, FOSAPREPITANT DIMEGLUMINE

A - 19

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

EMLA, LIDOCAINE
EMOQUETTE, DESOGESTREL
EMSAM, SELEGILINE
EMTRIVA, EMTRICITABINE
ENABLEX, DARIFENACIN HYDROBROMIDE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
ENALAPRILAT, ENALAPRILAT
ENDOMETRIN, PROGESTERONE
ENDOSOL EXTRA, CALCIUM CHLORIDE
ENDURON, METHYCLOTHIAZIDE
ENFLURANE, ENFLURANE
ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B
ENLON, EDROPHONIUM CHLORIDE
ENLON-PLUS, ATROPINE SULFATE
ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM
ENOXAPARIN SODIUM, ENOXAPARIN SODIUM
ENPRESSE-28, ETHINYL ESTRADIOL
ENTEREG, ALVIMOPAN
ENTOCORT EC, BUDESONIDE
ENULOSE, LACTULOSE
EOVIST, GADOXETATE DISODIUM
EPIDUO, ADAPALENE
EPIFOAM, HYDROCORTISONE ACETATE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
EPINEPHRINE, EPINEPHRINE (OTC)
EPIPEN JR., EPINEPHRINE
EPIPEN, EPINEPHRINE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
EPITOL, CARBAMAZEPINE
EPIVIR, LAMIVUDINE
EPIVIR-HBV, LAMIVUDINE
EPLERENONE, EPLERENONE
EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM
EPROSARTAN MESYLATE, EPROSARTAN MESYLATE
EPZICOM, ABACAVIR SULFATE
EQUETRO, CARBAMAZEPINE
ERAXIS, ANIDULAFUNGIN
ERGOCALCIFEROL, ERGOCALCIFEROL
ERGOLOID MESYLATES, ERGOLOID MESYLATES
ERGOMAR, ERGOTAMINE TARTRATE
ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE
ERRIN, NORETHINDRONE
ERTACZO, SERTACONAZOLE NITRATE
ERYC, ERYTHROMYCIN
ERYGEL, ERYTHROMYCIN
ERYPED, ERYTHROMYCIN ETHYLSUCCINATE
ERY-TAB, ERYTHROMYCIN
ERYTHRA-DERM, ERYTHROMYCIN
ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE
ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE
ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN, ERYTHROMYCIN
ERYTHRO-STATIN, ERYTHROMYCIN
ESGIC-PLUS, ACETAMINOPHEN
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
ESTAZOLAM, ESTAZOLAM
ESTRACE, ESTRADIOL
ESTRADERM, ESTRADIOL
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
ESTRADIOL AND NORGESTIMATE, ESTRADIOL

A - 20

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ESTRADIOL CYPIONATE, ESTRADIOL CYPIONATE

ESTRADIOL VALERATE, ESTRADIOL VALERATE
ESTRADIOL, ESTRADIOL
ESTRASORB, ESTRADIOL HEMIHYDRATE
ESTRING, ESTRADIOL
ESTROGEL, ESTRADIOL
ESTRONE, ESTRONE
ESTROPIPATE, ESTROPIPATE
ESTROSTEP FE, ETHINYL ESTRADIOL
ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE
ETHAMOLIN, ETHANOLAMINE OLEATE
ETHOSUXIMIDE, ETHOSUXIMIDE
ETHRANE, ENFLURANE
ETHYOL, AMIFOSTINE
ETIDRONATE DISODIUM, ETIDRONATE DISODIUM
ETODOLAC, ETODOLAC
ETOMIDATE, ETOMIDATE
ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE
ETOPOSIDE, ETOPOSIDE
EURAX, CROTAMITON
EVAMIST, ESTRADIOL
EVISTA, RALOXIFENE HYDROCHLORIDE
EVOCLIN, CLINDAMYCIN PHOSPHATE
EVOXAC, CEVIMELINE HYDROCHLORIDE
EXALGO, HYDROMORPHONE HYDROCHLORIDE
EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC)
EXELDERM, SULCONAZOLE NITRATE
EXELON, RIVASTIGMINE
EXELON, RIVASTIGMINE TARTRATE
EXEMESTANE, EXEMESTANE
EXFORGE HCT, AMLODIPINE BESYLATE
EXFORGE, AMLODIPINE BESYLATE
EXIDINE, CHLORHEXIDINE GLUCONATE (OTC)
EXJADE, DEFERASIROX
EXPAREL, BUPIVACAINE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
EXTINA, KETOCONAZOLE
EXTRANEAL, ICODEXTRIN
E-Z SCRUB 201, POVIDONE-IODINE (OTC)
E-Z SCRUB 241, POVIDONE-IODINE (OTC)

**

**

FACTIVE, GEMIFLOXACIN MESYLATE

FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK), FAMOTIDINE
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
FAMVIR, FAMCICLOVIR
FANAPT, ILOPERIDONE
FARESTON, TOREMIFENE CITRATE
FASLODEX, FULVESTRANT
FAZACLO ODT, CLOZAPINE
FELBAMATE, FELBAMATE
FELBATOL, FELBAMATE
FELDENE, PIROXICAM
FELODIPINE, FELODIPINE
FEMARA, LETROZOLE
FEMCON FE, ETHINYL ESTRADIOL
FEMHRT, ETHINYL ESTRADIOL
FEMRING, ESTRADIOL ACETATE
FEMSTAT 3, BUTOCONAZOLE NITRATE (OTC)

A - 21

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

A - 22

**

FEMTRACE, ESTRADIOL ACETATE

FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
FENOGLIDE, FENOFIBRATE
FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE
FENOPROFEN CALCIUM, FENOPROFEN CALCIUM
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
FENTANYL CITRATE, FENTANYL CITRATE
FENTANYL-100, FENTANYL
FENTANYL-12, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
FENTORA, FENTANYL CITRATE
FERAHEME, FERUMOXYTOL
FERIDEX I.V., FERUMOXIDES
FERRIPROX, DEFERIPRONE
FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FIBRICOR, FENOFIBRIC ACID
FINACEA, AZELAIC ACID
FINASTERIDE, FINASTERIDE
FIORICET W/ CODEINE, ACETAMINOPHEN
FIORICET, ACETAMINOPHEN
FIORINAL W/CODEINE, ASPIRIN
FIORINAL, ASPIRIN
FIRAZYR, ICATIBANT ACETATE
FIRMAGON, DEGARELIX ACETATE
FLAGYL ER, METRONIDAZOLE
FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE
FLAGYL, METRONIDAZOLE
FLAREX, FLUOROMETHOLONE ACETATE
FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLECTOR, DICLOFENAC EPOLAMINE
FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE
FLOLAN, EPOPROSTENOL SODIUM
FLOMAX, TAMSULOSIN HYDROCHLORIDE
FLONASE, FLUTICASONE PROPIONATE
FLO-PRED, PREDNISOLONE ACETATE
FLOVENT DISKUS 100, FLUTICASONE PROPIONATE
FLOVENT DISKUS 250, FLUTICASONE PROPIONATE
FLOVENT DISKUS 50, FLUTICASONE PROPIONATE
FLOVENT HFA, FLUTICASONE PROPIONATE
FLOXIN OTIC, OFLOXACIN
FLOXURIDINE, FLOXURIDINE
FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FLUCONAZOLE, FLUCONAZOLE
FLUCYTOSINE, FLUCYTOSINE
FLUDARA, FLUDARABINE PHOSPHATE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUDEOXYGLUCOSE F 18, FLUDEOXYGLUCOSE F-18
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
FLUMADINE, RIMANTADINE HYDROCHLORIDE

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

FLUMAZENIL, FLUMAZENIL
FLUNISOLIDE, FLUNISOLIDE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUORESCITE, FLUORESCEIN SODIUM
FLUOROPLEX, FLUOROURACIL
FLUOROURACIL, FLUOROURACIL
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUOXYMESTERONE, FLUOXYMESTERONE
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE
FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM
FLURBIPROFEN, FLURBIPROFEN
FLUTAMIDE, FLUTAMIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
FML FORTE, FLUOROMETHOLONE
FML, FLUOROMETHOLONE
FOAMCOAT, ALUMINUM HYDROXIDE (OTC)
FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE
FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE
FOLIC ACID, FOLIC ACID
FOLLISTIM AQ, FOLLITROPIN ALFA/BETA
FOLOTYN, PRALATREXATE
FOMEPIZOLE, FOMEPIZOLE
FONDAPARINUX SODIUM, FONDAPARINUX SODIUM
FORADIL, FORMOTEROL FUMARATE
FORANE, ISOFLURANE
FORFIVO XL, BUPROPION HYDROCHLORIDE
FORTAMET, METFORMIN HYDROCHLORIDE
FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM
FORTAZ, CEFTAZIDIME
FORTEO, TERIPARATIDE RECOMBINANT HUMAN
FORTESTA, TESTOSTERONE
FORTICAL, CALCITONIN SALMON RECOMBINANT
FOSAMAX PLUS D, ALENDRONATE SODIUM
FOSAMAX, ALENDRONATE SODIUM
FOSCARNET SODIUM, FOSCARNET SODIUM
FOSCAVIR, FOSCARNET SODIUM
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FOSRENOL, LANTHANUM CARBONATE
FRAGMIN, DALTEPARIN SODIUM
FREAMINE HBC 6.9%, AMINO ACIDS
FREAMINE III 10%, AMINO ACIDS
FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5%, AMINO ACIDS
FROVA, FROVATRIPTAN SUCCINATE
FULCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FURADANTIN, NITROFURANTOIN
FUROSEMIDE, FUROSEMIDE
FUSILEV, LEVOLEUCOVORIN CALCIUM
FUZEON, ENFUVIRTIDE

**
GABAPENTIN, GABAPENTIN
GABITRIL, TIAGABINE HYDROCHLORIDE
GABLOFEN, BACLOFEN

**

A - 23

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

GADAVIST, GADOBUTROL
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67
GALZIN, ZINC ACETATE
GANCICLOVIR, GANCICLOVIR
GANCICLOVIR, GANCICLOVIR SODIUM
GANIRELIX ACETATE INJECTION, GANIRELIX ACETATE
GANITE, GALLIUM NITRATE
GASTROCROM, CROMOLYN SODIUM
GASTROGRAFIN, DIATRIZOATE MEGLUMINE
GASTROMARK, FERUMOXSIL
GATIFLOXACIN, GATIFLOXACIN
GAVISCON, ALUMINUM HYDROXIDE (OTC)
GELNIQUE, OXYBUTYNIN CHLORIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GEMCITABINE, GEMCITABINE HYDROCHLORIDE
GEMFIBROZIL, GEMFIBROZIL
GEMZAR, GEMCITABINE HYDROCHLORIDE
GENERLAC, LACTULOSE
GENGRAF, CYCLOSPORINE
GENOPTIC, GENTAMICIN SULFATE
GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT
GENOTROPIN, SOMATROPIN RECOMBINANT
GENTAK, GENTAMICIN SULFATE
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GEN-XENE, CLORAZEPATE DIPOTASSIUM
GEODON, ZIPRASIDONE HYDROCHLORIDE
GEODON, ZIPRASIDONE MESYLATE
GILDESS FE 1.5/30, ETHINYL ESTRADIOL
GILDESS FE 1/20, ETHINYL ESTRADIOL
GILENYA, FINGOLIMOD
GLEEVEC, IMATINIB MESYLATE
GLIADEL, CARMUSTINE
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLIPIZIDE, GLIPIZIDE
GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT
GLUCAGON, GLUCAGON RECOMBINANT
GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE
GLUCOPHAGE, METFORMIN HYDROCHLORIDE
GLUCOTROL XL, GLIPIZIDE
GLUCOTROL, GLIPIZIDE
GLUCOVANCE, GLYBURIDE
GLUMETZA, METFORMIN HYDROCHLORIDE
GLYBURIDE (MICRONIZED), GLYBURIDE
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GLYBURIDE, GLYBURIDE
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
GLYCOLAX, POLYETHYLENE GLYCOL 3350
GLYCOLAX, POLYETHYLENE GLYCOL 3350 (OTC)
GLYCOPYRROLATE, GLYCOPYRROLATE
GLYNASE, GLYBURIDE
GLYSET, MIGLITOL
GOLYTELY, POLYETHYLENE GLYCOL 3350
GONAL-F RFF PEN, FOLLITROPIN ALFA/BETA
GONAL-F RFF, FOLLITROPIN ALFA/BETA
GONAL-F, FOLLITROPIN ALFA/BETA
GRALISE, GABAPENTIN
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
GRANISTERON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
GRIFULVIN V, GRISEOFULVIN, MICROCRYSTALLINE

A - 24

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

GRISEOFULVIN, GRISEOFULVIN
GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE
GRIS-PEG, GRISEOFULVIN, ULTRAMICROCRYSTALLINE
GUAIFENESIN, GUAIFENESIN (OTC)
GUANABENZ ACETATE, GUANABENZ ACETATE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE
GYNAZOLE-1, BUTOCONAZOLE NITRATE
GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN 3, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN, CLOTRIMAZOLE (OTC)

**

**

H.P. ACTHAR GEL, CORTICOTROPIN

HABITROL, NICOTINE (OTC)
HALAVEN, ERIBULIN MESYLATE
HALCION, TRIAZOLAM
HALDOL, HALOPERIDOL DECANOATE
HALDOL, HALOPERIDOL LACTATE
HALFLYTELY, BISACODYL
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
HALOG, HALCINONIDE
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL
HALOPERIDOL, HALOPERIDOL LACTATE
HEATHER, NORETHINDRONE
HECTOROL, DOXERCALCIFEROL
HELIDAC, BISMUTH SUBSALICYLATE
HEMABATE, CARBOPROST TROMETHAMINE
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
HEPATAMINE 8%, AMINO ACIDS
HEPATASOL 8%, AMINO ACIDS
HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT
HEPSERA, ADEFOVIR DIPIVOXIL
HERPLEX, IDOXURIDINE
HEXABRIX, IOXAGLATE MEGLUMINE
HEXALEN, ALTRETAMINE
HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)
HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)
HICON, SODIUM IODIDE I-131
HIPREX, METHENAMINE HIPPURATE
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE
HORIZANT, GABAPENTIN ENACARBIL
HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT
HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 50/50 PEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

A - 25

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

HUMALOG MIX 75/25 PEN, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG PEN, INSULIN LISPRO RECOMBINANT
HUMALOG, INSULIN LISPRO RECOMBINANT
HUMATROPE, SOMATROPIN RECOMBINANT
HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN R, INSULIN RECOMBINANT HUMAN
HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC)
HYCAMTIN, TOPOTECAN HYDROCHLORIDE
HYDASE, HYALURONIDASE
HYDERGINE, ERGOLOID MESYLATES
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE
HYDREA, HYDROXYUREA
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, CHLORPHENIRAMINE POLISTIREX
HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE
HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE
HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE
HYDROCORTISONE, HYDROCORTISONE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
HYDRO-RX, HYDROCORTISONE
HYDROXOCOBALAMIN, HYDROXOCOBALAMIN
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
HYDROXYUREA, HYDROXYUREA
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN
HYTRIN, TERAZOSIN HYDROCHLORIDE
HYZAAR, HYDROCHLOROTHIAZIDE

**

**

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)

IBUPROFEN AND DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
IBUPROHM COLD AND SINUS, IBUPROFEN (OTC)
IBUPROHM, IBUPROFEN (OTC)
IBU-TAB 200, IBUPROFEN (OTC)
IBU-TAB, IBUPROFEN
IBUTILIDE FUMARATE, IBUTILIDE FUMARATE
IC-GREEN, INDOCYANINE GREEN
IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
IDKIT:HP, UREA C-13
IFEX, IFOSFAMIDE
IFOSFAMIDE, IFOSFAMIDE
IFOSFAMIDE/MESNA KIT, IFOSFAMIDE
IMIPENEM AND CILASTATIN, CILASTATIN SODIUM
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE
IMIQUIMOD, IMIQUIMOD
IMITREX STATDOSE, SUMATRIPTAN SUCCINATE

A - 26

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

IMITREX, SUMATRIPTAN
IMITREX, SUMATRIPTAN SUCCINATE
IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM, LOPERAMIDE HYDROCHLORIDE
IMPLANON, ETONOGESTREL
IMURAN, AZATHIOPRINE
INAPSINE, DROPERIDOL
INCIVEK, TELAPREVIR
INCRELEX, MECASERMIN RECOMBINANT
INDAPAMIDE, INDAPAMIDE
INDERAL LA, PROPRANOLOL HYDROCHLORIDE
INDERAL, PROPRANOLOL HYDROCHLORIDE
INDERIDE-40/25, HYDROCHLOROTHIAZIDE
INDICLOR, INDIUM IN-111 CHLORIDE
INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE
INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE
INDOCIN, INDOMETHACIN
INDOCIN, INDOMETHACIN SODIUM
INDOCYANINE GREEN, INDOCYANINE GREEN
INDOMETHACIN SODIUM, INDOMETHACIN SODIUM
INDOMETHACIN, INDOMETHACIN
INFANTS' FEVERALL, ACETAMINOPHEN (OTC)
INFASURF PRESERVATIVE FREE, CALFACTANT
INFED, IRON DEXTRAN
INFUMORPH, MORPHINE SULFATE
INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID
INFUVITE PEDIATRIC, ASCORBIC ACID
INNOHEP, TINZAPARIN SODIUM
INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE
INOMAX, NITRIC OXIDE
INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
INSPRA, EPLERENONE
INTAL, CROMOLYN SODIUM
INTEGRILIN, EPTIFIBATIDE
INTELENCE, ETRAVIRINE
INTERMEZZO, ZOLPIDEM TARTRATE
INTRALIPID 10%, SOYBEAN OIL
INTRALIPID 20%, SOYBEAN OIL
INTRALIPID 30%, SOYBEAN OIL
INTROVALE, ETHINYL ESTRADIOL
INTUNIV, GUANFACINE HYDROCHLORIDE
INVAGESIC FORTE, ASPIRIN
INVAGESIC, ASPIRIN
INVANZ, ERTAPENEM SODIUM
INVEGA SUSTENNA, PALIPERIDONE PALMITATE
INVEGA, PALIPERIDONE
INVIRASE, SAQUINAVIR MESYLATE
IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IOPAMIDOL-250, IOPAMIDOL
IOPAMIDOL-300, IOPAMIDOL
IOPAMIDOL-370, IOPAMIDOL
IOPIDINE, APRACLONIDINE HYDROCHLORIDE
IOSAT, POTASSIUM IODIDE (OTC)
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
IPRIVASK, DESIRUDIN RECOMBINANT
IQUIX, LEVOFLOXACIN

A - 27

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ISENTRESS, RALTEGRAVIR POTASSIUM
ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN, LEVONORDEFRIN
ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
ISOFLURANE, ISOFLURANE
ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE E IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ISONIAZID, ISONIAZID
ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE
ISOPTIN SR, VERAPAMIL HYDROCHLORIDE
ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE
ISORDIL, ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
ISOSULFAN BLUE, ISOSULFAN BLUE
ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER, GENTAMICIN SULFATE
ISOVUE-200, IOPAMIDOL
ISOVUE-250, IOPAMIDOL
ISOVUE-300, IOPAMIDOL
ISOVUE-370, IOPAMIDOL
ISOVUE-M 200, IOPAMIDOL
ISOVUE-M 300, IOPAMIDOL
ISRADIPINE, ISRADIPINE
ISTALOL, TIMOLOL MALEATE
ISTODAX, ROMIDEPSIN
ISUPREL, ISOPROTERENOL HYDROCHLORIDE
ITRACONAZOLE, ITRACONAZOLE
IVY BLOCK, BENTOQUATAM (OTC)
IXEMPRA KIT, IXABEPILONE

**

**

**

JAKAFI, RUXOLITINIB PHOSPHATE

JALYN, DUTASTERIDE
JANTOVEN, WARFARIN SODIUM
JANUMET, METFORMIN HYDROCHLORIDE
JANUVIA, SITAGLIPTIN PHOSPHATE
JEANATOPE, ALBUMIN IODINATED I-125 SERUM
JEVTANA KIT, CABAZITAXEL
JUNEL 1.5/30, ETHINYL ESTRADIOL
JUNEL 1/20, ETHINYL ESTRADIOL
JUNEL FE 1.5/30, ETHINYL ESTRADIOL
JUNEL FE 1/20, ETHINYL ESTRADIOL
JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)
JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC)
JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC)
JUVISYNC, SIMVASTATIN

**
K+10, POTASSIUM CHLORIDE
KADIAN, MORPHINE SULFATE
KALETRA, LOPINAVIR
KALEXATE, SODIUM POLYSTYRENE SULFONATE
KANAMYCIN SULFATE, KANAMYCIN SULFATE
KAON CL-10, POTASSIUM CHLORIDE
KAPVAY, CLONIDINE HYDROCHLORIDE

A - 28

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

**

KARIVA, DESOGESTREL
KAYEXALATE, SODIUM POLYSTYRENE SULFONATE
KEFLEX, CEPHALEXIN
KEFZOL, CEFAZOLIN SODIUM
KELNOR, ETHINYL ESTRADIOL
KENALOG, TRIAMCINOLONE ACETONIDE
KENALOG-10, TRIAMCINOLONE ACETONIDE
KENALOG-40, TRIAMCINOLONE ACETONIDE
KEPPRA XR, LEVETIRACETAM
KEPPRA, LEVETIRACETAM
KETALAR, KETAMINE HYDROCHLORIDE
KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE
KETEK, TELITHROMYCIN
KETOCONAZOLE, KETOCONAZOLE
KETOPROFEN, KETOPROFEN
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)
KETOZOLE, KETOCONAZOLE
KINEVAC, SINCALIDE
KIONEX, SODIUM POLYSTYRENE SULFONATE
KLARON, SULFACETAMIDE SODIUM
KLONOPIN, CLONAZEPAM
KLOR-CON M10, POTASSIUM CHLORIDE
KLOR-CON M15, POTASSIUM CHLORIDE
KLOR-CON M20, POTASSIUM CHLORIDE
KLOR-CON, POTASSIUM CHLORIDE
KLOTRIX, POTASSIUM CHLORIDE
KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE
K-TAB, POTASSIUM CHLORIDE
KUVAN, SAPROPTERIN DIHYDROCHLORIDE

**

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LABETALOL HYDROCLORIDE, LABETALOL HYDROCHLORIDE
LAC-HYDRIN, AMMONIUM LACTATE
LACRISERT, HYDROXYPROPYL CELLULOSE
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LACTULOSE, LACTULOSE
LAMICTAL CD, LAMOTRIGINE
LAMICTAL ODT, LAMOTRIGINE
LAMICTAL XR, LAMOTRIGINE
LAMICTAL, LAMOTRIGINE
LAMISIL AT, TERBINAFINE (OTC)
LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC)
LAMISIL, TERBINAFINE HYDROCHLORIDE
LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC)
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMIVUDINE, LAMIVUDINE
LAMOTRIGINE, LAMOTRIGINE
LAMPRENE, CLOFAZIMINE
LANORINAL, ASPIRIN
LANOXIN PEDIATRIC, DIGOXIN
LANOXIN, DIGOXIN
LANSOPRAZOLE, LANSOPRAZOLE
LANTUS, INSULIN GLARGINE RECOMBINANT
LAROTID, AMOXICILLIN
LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE
LASIX, FUROSEMIDE
LASTACAFT, ALCAFTADINE
LATANOPROST, LATANOPROST
LATISSE, BIMATOPROST
LATUDA, LURASIDONE HYDROCHLORIDE

A - 29

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

A - 30

**

LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350

LAZANDA, FENTANYL CITRATE
LEFLUNOMIDE, LEFLUNOMIDE
LESCOL XL, FLUVASTATIN SODIUM
LESCOL, FLUVASTATIN SODIUM
LESSINA-28, ETHINYL ESTRADIOL
LETAIRIS, AMBRISENTAN
LETROZOLE, LETROZOLE
LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEUKERAN, CHLORAMBUCIL
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE
LEUSTATIN, CLADRIBINE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVAQUIN, LEVOFLOXACIN
LEVATOL, PENBUTOLOL SULFATE
LEVEMIR, INSULIN DETEMIR RECOMBINANT
LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM
LEVETIRACETAM, LEVETIRACETAM
LEVITRA, VARDENAFIL HYDROCHLORIDE
LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE
LEVOCARNITINE, LEVOCARNITINE
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVOFLOXACIN, LEVOFLOXACIN
LEVONEST, ETHINYL ESTRADIOL
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL (OTC)
LEVOPHED, NOREPINEPHRINE BITARTRATE
LEVORA 0.15/30-28, ETHINYL ESTRADIOL
LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE
LEVO-T, LEVOTHYROXINE SODIUM
LEVOTHROID, LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM
LEVOXYL, LEVOTHYROXINE SODIUM
LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE
LEXAPRO, ESCITALOPRAM OXALATE
LEXISCAN, REGADENOSON
LEXIVA, FOSAMPRENAVIR CALCIUM
LIALDA, MESALAMINE
LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE
LIDEX, FLUOCINONIDE
LIDEX-E, FLUOCINONIDE
LIDOCAINE AND PRILOCAINE, LIDOCAINE
LIDOCAINE AND TETRACAINE, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
LIDOCAINE, LIDOCAINE
LIDODERM, LIDOCAINE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

LIDOPEN, LIDOCAINE HYDROCHLORIDE

LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE
LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE
LIMBITROL DS, AMITRIPTYLINE HYDROCHLORIDE
LIMBITROL, AMITRIPTYLINE HYDROCHLORIDE
LINCOCIN, LINCOMYCIN HYDROCHLORIDE
LINDANE, LINDANE
LIORESAL, BACLOFEN
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
LIPITOR, ATORVASTATIN CALCIUM
LIPOFEN, FENOFIBRATE
LIPOSYN II 10%, SAFFLOWER OIL
LIPOSYN II 20%, SAFFLOWER OIL
LIPOSYN III 10%, SOYBEAN OIL
LIPOSYN III 20%, SOYBEAN OIL
LIPOSYN III 30%, SOYBEAN OIL
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LITHIUM CARBONATE, LITHIUM CARBONATE
LITHIUM CITRATE, LITHIUM CITRATE
LITHOBID, LITHIUM CARBONATE
LITHOSTAT, ACETOHYDROXAMIC ACID
LIVALO, PITAVASTATIN CALCIUM
LO LOESTRIN FE, ETHINYL ESTRADIOL
LO/OVRAL-28, ETHINYL ESTRADIOL
LOCHOLEST LIGHT, CHOLESTYRAMINE
LOCHOLEST, CHOLESTYRAMINE
LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE
LOCOID, HYDROCORTISONE BUTYRATE
LODOSYN, CARBIDOPA
LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL
LOESTRIN 21 1/20, ETHINYL ESTRADIOL
LOESTRIN 24 FE, ETHINYL ESTRADIOL
LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL
LOESTRIN FE 1/20, ETHINYL ESTRADIOL
LOMOTIL, ATROPINE SULFATE
LONOX, ATROPINE SULFATE
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LOPID, GEMFIBROZIL
LOPRESSOR HCT, HYDROCHLOROTHIAZIDE
LOPRESSOR, METOPROLOL TARTRATE
LOPROX, CICLOPIROX
LOPURIN, ALLOPURINOL
LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)
LORATADINE REDIDOSE, LORATADINE (OTC)
LORATADINE, LORATADINE (OTC)
LORAZEPAM INTENSOL, LORAZEPAM
LORAZEPAM PRESERVATIVE FREE, LORAZEPAM
LORAZEPAM, LORAZEPAM
LORTAB, ACETAMINOPHEN
LORYNA, DROSPIRENONE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOSEASONIQUE, ETHINYL ESTRADIOL
LOTEMAX, LOTEPREDNOL ETABONATE
LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE
LOTENSIN, BENAZEPRIL HYDROCHLORIDE
LOTREL, AMLODIPINE BESYLATE
LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC)
LOTRISONE, BETAMETHASONE DIPROPIONATE
LOTRONEX, ALOSETRON HYDROCHLORIDE

(OTC)

A - 31

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

**

LOVASTATIN, LOVASTATIN
LOVAZA, OMEGA-3-ACID ETHYL ESTERS
LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM
LOVENOX, ENOXAPARIN SODIUM
LOW-OGESTREL-21, ETHINYL ESTRADIOL
LOW-OGESTREL-28, ETHINYL ESTRADIOL
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
LTA II KIT, LIDOCAINE HYDROCHLORIDE
LUFYLLIN, DYPHYLLINE
LUMIGAN, BIMATOPROST
LUNESTA, ESZOPICLONE
LUPRON DEPOT, LEUPROLIDE ACETATE
LUPRON DEPOT-PED, LEUPROLIDE ACETATE
LUSEDRA, FOSPROPOFOL DISODIUM
LUVERIS, LUTROPIN ALFA
LUVOX CR, FLUVOXAMINE MALEATE
LUVOX, FLUVOXAMINE MALEATE
LUXIQ, BETAMETHASONE VALERATE
LYBREL, ETHINYL ESTRADIOL
LYMPHAZURIN, ISOSULFAN BLUE
LYRICA, PREGABALIN
LYSODREN, MITOTANE
LYSTEDA, TRANEXAMIC ACID

**

M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID

M.V.I. ADULT, ASCORBIC ACID
M.V.I. PEDIATRIC, ASCORBIC ACID
M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID
MACROBID, NITROFURANTOIN
MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE
MACUGEN, PEGAPTANIB SODIUM
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE, MAGNESIUM HYDROXIDE
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE, MAGNESIUM SULFATE
MAGNEVIST, GADOPENTETATE DIMEGLUMINE
MAKENA, HYDROXYPROGESTERONE CAPROATE
MALARONE PEDIATRIC, ATOVAQUONE
MALARONE, ATOVAQUONE
MALATHION, MALATHION
MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE
MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER, MANNITOL
MANNITOL 10%, MANNITOL
MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%, MANNITOL
MANNITOL 15%, MANNITOL
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 20%, MANNITOL
MANNITOL 25%, MANNITOL
MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%, MANNITOL
MANNITOL 5%, MANNITOL
MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
MARCAINE, BUPIVACAINE HYDROCHLORIDE
MARINOL, DRONABINOL
MARPLAN, ISOCARBOXAZID
MATULANE, PROCARBAZINE HYDROCHLORIDE

A - 32

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

MAVIK, TRANDOLAPRIL
MAXAIR, PIRBUTEROL ACETATE
MAXALT, RIZATRIPTAN BENZOATE
MAXALT-MLT, RIZATRIPTAN BENZOATE
MAXIDEX, DEXAMETHASONE
MAXIPIME, CEFEPIME HYDROCHLORIDE
MAXITROL, DEXAMETHASONE
MAXZIDE, HYDROCHLOROTHIAZIDE
MAXZIDE-25, HYDROCHLOROTHIAZIDE
MD-76R, DIATRIZOATE MEGLUMINE
MD-GASTROVIEW, DIATRIZOATE MEGLUMINE
MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT
MEBENDAZOLE, MEBENDAZOLE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM
MEDROL, METHYLPREDNISOLONE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MEFENAMIC ACID, MEFENAMIC ACID
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM
MEGACE ES, MEGESTROL ACETATE
MEGACE, MEGESTROL ACETATE
MEGATOPE, ALBUMIN IODINATED I-131 SERUM
MEGESTROL ACETATE, MEGESTROL ACETATE
MELOXICAM, MELOXICAM
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
MEMBRANEBLUE, TRYPAN BLUE
MENEST, ESTROGENS, ESTERIFIED
MENOPUR, LUTEINIZING HORMONE
MENOSTAR, ESTRADIOL
MEN'S ROGAINE, MINOXIDIL (OTC)
MENTAX, BUTENAFINE HYDROCHLORIDE
MENTAX-TC, BUTENAFINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
MEPHYTON, PHYTONADIONE
MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
MEPROBAMATE, MEPROBAMATE
MEPRON, ATOVAQUONE
MERCAPTOPURINE, MERCAPTOPURINE
MEROPENEM, MEROPENEM
MERREM, MEROPENEM
MESALAMINE, MESALAMINE
MESNA, MESNA
MESNEX, MESNA
MESTINON, PYRIDOSTIGMINE BROMIDE
METADATE CD, METHYLPHENIDATE HYDROCHLORIDE
METADATE ER, METHYLPHENIDATE HYDROCHLORIDE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METARAMINOL BITARTRATE, METARAMINOL BITARTRATE
METASTRON, STRONTIUM CHLORIDE SR-89
METAXALONE, METAXALONE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHADOSE, METHADONE HYDROCHLORIDE
METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE
METHAZOLAMIDE, METHAZOLAMIDE
METHENAMINE HIPPURATE, METHENAMINE HIPPURATE
METHERGINE, METHYLERGONOVINE MALEATE
METHIMAZOLE, METHIMAZOLE
METHOCARBAMOL AND ASPIRIN, ASPIRIN
METHOCARBAMOL, METHOCARBAMOL

A - 33

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM
METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE
METHYCLOTHIAZIDE, METHYCLOTHIAZIDE
METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METHYLDOPA, METHYLDOPA
METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE
METHYLIN, METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
METHYLPREDNISOLONE, METHYLPREDNISOLONE
METHYLTESTOSTERONE, METHYLTESTOSTERONE
METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOLAZONE, METOLAZONE
METOPIRONE, METYRAPONE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE
METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE
METROCREAM, METRONIDAZOLE
METROGEL, METRONIDAZOLE
METROGEL-VAGINAL, METRONIDAZOLE
METROLOTION, METRONIDAZOLE
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
METRONIDAZOLE, METRONIDAZOLE
METVIXIA, METHYL AMINOLEVULINATE HYDROCHLORIDE
MEVACOR, LOVASTATIN
MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE
MIACALCIN, CALCITONIN SALMON
MICARDIS HCT, HYDROCHLOROTHIAZIDE
MICARDIS, TELMISARTAN
MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MICONAZOLE 3, MICONAZOLE NITRATE (OTC)
MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MICONAZOLE 7, MICONAZOLE NITRATE (OTC)
MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
MICORT-HC, HYDROCORTISONE ACETATE
MICROGESTIN 1.5/30, ETHINYL ESTRADIOL
MICROGESTIN 1/20, ETHINYL ESTRADIOL
MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL
MICROGESTIN FE 1/20, ETHINYL ESTRADIOL
MICRO-K 10, POTASSIUM CHLORIDE
MICRO-K, POTASSIUM CHLORIDE
MICRONOR, NORETHINDRONE
MICROZIDE, HYDROCHLOROTHIAZIDE
MIDAMOR, AMILORIDE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MIDOL LIQUID GELS, IBUPROFEN (OTC)
MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MIFEPREX, MIFEPRISTONE
MIGERGOT, CAFFEINE
MIGRANAL, DIHYDROERGOTAMINE MESYLATE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE

A - 34

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

A - 35

**

MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE

MILRINONE LACTATE, MILRINONE LACTATE
MINIPRESS, PRAZOSIN HYDROCHLORIDE
MINIRIN, DESMOPRESSIN ACETATE
MINITRAN, NITROGLYCERIN
MINOCIN, MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL, MINOXIDIL
MINOXIDIL, MINOXIDIL (OTC)
MIOCHOL-E, ACETYLCHOLINE CHLORIDE
MIOSTAT, CARBACHOL
MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC)
MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE
MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE
MIRCETTE, DESOGESTREL
MIRENA, LEVONORGESTREL
MIRTAZAPINE, MIRTAZAPINE
MISOPROSTOL, MISOPROSTOL
MITOMYCIN, MITOMYCIN
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
MOBIC, MELOXICAM
MODICON 28, ETHINYL ESTRADIOL
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MOMETASONE FUROATE, MOMETASONE FUROATE
MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC)
MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 3, MICONAZOLE NITRATE
MONISTAT 3, MICONAZOLE NITRATE (OTC)
MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 7, MICONAZOLE NITRATE (OTC)
MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
MONODOX, DOXYCYCLINE
MONOKET, ISOSORBIDE MONONITRATE
MONOPRIL, FOSINOPRIL SODIUM
MONUROL, FOSFOMYCIN TROMETHAMINE
MORPHINE SULFATE, MORPHINE SULFATE
MOTOFEN, ATROPINE SULFATE
MOTRIN IB, IBUPROFEN (OTC)
MOTRIN MIGRAINE PAIN, IBUPROFEN (OTC)
MOVIPREP, ASCORBIC ACID
MOXATAG, AMOXICILLIN
MOXEZA, MOXIFLOXACIN HYDROCHLORIDE
MOZOBIL, PLERIXAFOR
MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT
MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM
MS CONTIN, MORPHINE SULFATE
MUCINEX D, GUAIFENESIN (OTC)
MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC)
MUCINEX, GUAIFENESIN (OTC)
MULTAQ, DRONEDARONE HYDROCHLORIDE
MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE
MULTIHANCE, GADOBENATE DIMEGLUMINE
MUPIROCIN, MUPIROCIN
MUSE, ALPROSTADIL
MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE
MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE
MYCAMINE, MICAFUNGIN SODIUM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

MYCELEX, CLOTRIMAZOLE
MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE (OTC)
MYCELEX-7, CLOTRIMAZOLE (OTC)
MYCOBUTIN, RIFABUTIN
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
MYDRIACYL, TROPICAMIDE
MYFORTIC, MYCOPHENOLIC ACID
MYLERAN, BUSULFAN
MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT
MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT
MYSOLINE, PRIMIDONE
MYTELASE, AMBENONIUM CHLORIDE
M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

**

**

NABUMETONE, NABUMETONE
NADOLOL AND BENDROFLUMETHAZIDE, BENDROFLUMETHIAZIDE
NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE
NADOLOL, NADOLOL
NAFCILLIN SODIUM, NAFCILLIN SODIUM
NAFTIN, NAFTIFINE HYDROCHLORIDE
NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE
NALFON, FENOPROFEN CALCIUM
NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
NAMENDA XR, MEMANTINE HYDROCHLORIDE
NAMENDA, MEMANTINE HYDROCHLORIDE
NANDROLONE DECANOATE, NANDROLONE DECANOATE
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC)
NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE
NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
NAPRELAN, NAPROXEN SODIUM
NAPROSYN, NAPROXEN
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NAPROXEN, NAPROXEN
NARATRIPTAN, NARATRIPTAN
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NARDIL, PHENELZINE SULFATE
NAROPIN, ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
NASACORT AQ, TRIAMCINOLONE ACETONIDE
NASCOBAL, CYANOCOBALAMIN
NASONEX, MOMETASONE FUROATE MONOHYDRATE
NATACYN, NATAMYCIN
NATAZIA, ESTRADIOL VALERATE
NATEGLINIDE, NATEGLINIDE
NATRECOR, NESIRITIDE RECOMBINANT
NATROBA, SPINOSAD
NAVANE, THIOTHIXENE
NAVELBINE, VINORELBINE TARTRATE
NAVSTEL, CALCIUM CHLORIDE
NEBUPENT, PENTAMIDINE ISETHIONATE
NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE
NEMBUTAL SODIUM, PENTOBARBITAL SODIUM
NEO-FRADIN, NEOMYCIN SULFATE
NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC

A - 36

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

NEOMYCIN SULFATE, NEOMYCIN SULFATE

NEOPAP, ACETAMINOPHEN (OTC)
NEOPROFEN, IBUPROFEN LYSINE
NEORAL, CYCLOSPORINE
NEO-RX, NEOMYCIN SULFATE
NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE
NEOSPORIN, GRAMICIDIN
NEPHRAMINE 5.4%, AMINO ACIDS
NESACAINE, CHLOROPROCAINE HYDROCHLORIDE
NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE
NEUROLITE, TECHNETIUM TC-99M BICISATE KIT
NEURONTIN, GABAPENTIN
NEVANAC, NEPAFENAC
NEXAVAR, SORAFENIB TOSYLATE
NEXCEDE, KETOPROFEN (OTC)
NEXIUM IV, ESOMEPRAZOLE SODIUM
NEXIUM, ESOMEPRAZOLE MAGNESIUM
NEXPLANON, ETONOGESTREL
NEXTERONE, AMIODARONE HYDROCHLORIDE
NIACIN, NIACIN
NIACOR, NIACIN
NIASPAN, NIACIN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NICODERM CQ, NICOTINE (OTC)
NICORETTE (MINT), NICOTINE POLACRILEX (OTC)
NICORETTE, NICOTINE POLACRILEX (OTC)
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
NICOTINE, NICOTINE (OTC)
NICOTROL, NICOTINE
NIFEDIPINE, NIFEDIPINE
NILANDRON, NILUTAMIDE
NILSTAT, NYSTATIN
NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE
NIMBEX, CISATRACURIUM BESYLATE
NIMODIPINE, NIMODIPINE
NIPENT, PENTOSTATIN
NIRAVAM, ALPRAZOLAM
NISOLDIPINE, NISOLDIPINE
NITHIODOTE, SODIUM NITRITE
NITRO-DUR, NITROGLYCERIN
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN
NITROFURANTOIN, NITROFURANTOIN
NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN
NITROGLYCERIN, NITROGLYCERIN
NITROLINGUAL PUMPSPRAY, NITROGLYCERIN
NITROMIST, NITROGLYCERIN
NITROPRESS, SODIUM NITROPRUSSIDE
NITROSTAT, NITROGLYCERIN
NIX, PERMETHRIN (OTC)
NIZATIDINE, NIZATIDINE
NIZORAL A-D, KETOCONAZOLE (OTC)
NIZORAL, KETOCONAZOLE
NORCO, ACETAMINOPHEN
NORDETTE-28, ETHINYL ESTRADIOL
NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT
NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT
NORDITROPIN, SOMATROPIN RECOMBINANT
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
NORETHIDRONE, NORETHINDRONE
NORETHIN 1/35E-21, ETHINYL ESTRADIOL
NORETHIN 1/35E-28, ETHINYL ESTRADIOL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

A - 37

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14), ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORETHINDRONE, NORETHINDRONE
NORFLEX, ORPHENADRINE CITRATE
NORGESIC FORTE, ASPIRIN
NORGESIC, ASPIRIN
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL
NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL
NORINYL 1+50 28-DAY, MESTRANOL
NORITATE, METRONIDAZOLE
NORMOCARB HF 25, MAGNESIUM CHLORIDE
NORMOCARB HF 35, MAGNESIUM CHLORIDE
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
NOROXIN, NORFLOXACIN
NORPACE CR, DISOPYRAMIDE PHOSPHATE
NORPACE, DISOPYRAMIDE PHOSPHATE
NORPRAMIN, DESIPRAMINE HYDROCHLORIDE
NOR-QD, NORETHINDRONE
NORTREL 0.5/35-28, ETHINYL ESTRADIOL
NORTREL 1/35-21, ETHINYL ESTRADIOL
NORTREL 1/35-28, ETHINYL ESTRADIOL
NORTREL 7/7/7, ETHINYL ESTRADIOL
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
NORVASC, AMLODIPINE BESYLATE
NORVIR, RITONAVIR
NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT
NOVOLOG, INSULIN ASPART RECOMBINANT
NOXAFIL, POSACONAZOLE
NUCYNTA ER, TAPENTADOL HYDROCHLORIDE
NUCYNTA, TAPENTADOL HYDROCHLORIDE
NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE
NULYTELY, POLYETHYLENE GLYCOL 3350
NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350
NUTRACORT, HYDROCORTISONE
NUTRESTORE, GLUTAMINE
NUTRILIPID 10%, SOYBEAN OIL
NUTRILIPID 20%, SOYBEAN OIL
NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT
NUTROPIN AQ, SOMATROPIN RECOMBINANT
NUTROPIN, SOMATROPIN RECOMBINANT
NUVARING, ETHINYL ESTRADIOL
NUVIGIL, ARMODAFINIL
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
NYSTATIN, NYSTATIN
NYSTOP, NYSTATIN

**

**

OCTOCAINE, EPINEPHRINE
OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE (OTC)
OCUFEN, FLURBIPROFEN SODIUM

A - 38

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

A - 39

**

OCUFLOX, OFLOXACIN
OCUPRESS, CARTEOLOL HYDROCHLORIDE
OFIRMEV, ACETAMINOPHEN
OFLOXACIN, OFLOXACIN
OFORTA, FLUDARABINE PHOSPHATE
OGEN .625, ESTROPIPATE
OGEN 1.25, ESTROPIPATE
OGEN 2.5, ESTROPIPATE
OGEN 5, ESTROPIPATE
OGESTREL 0.5/50-28, ETHINYL ESTRADIOL
OLANZAPINE, OLANZAPINE
OLEPTRO, TRAZODONE HYDROCHLORIDE
OLUX E, CLOBETASOL PROPIONATE
OLUX, CLOBETASOL PROPIONATE
OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE
OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)
OMEPRAZOLE, OMEPRAZOLE
OMEPRAZOLE, OMEPRAZOLE (OTC)
OMNARIS, CICLESONIDE
OMNIPAQUE 140, IOHEXOL
OMNIPAQUE 180, IOHEXOL
OMNIPAQUE 240, IOHEXOL
OMNIPAQUE 300, IOHEXOL
OMNIPAQUE 350, IOHEXOL
OMNIPRED, PREDNISOLONE ACETATE
OMNISCAN, GADODIAMIDE
OMNITROPE, SOMATROPIN RECOMBINANT
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
ONFI, CLOBAZAM
ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE
ONMEL, ITRACONAZOLE
ONSOLIS, FENTANYL CITRATE
OPANA ER, OXYMORPHONE HYDROCHLORIDE
OPANA, OXYMORPHONE HYDROCHLORIDE
OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
OPHTHAINE, PROPARACAINE HYDROCHLORIDE
OPHTHETIC, PROPARACAINE HYDROCHLORIDE
OPTICROM, CROMOLYN SODIUM
OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE
OPTIMARK, GADOVERSETAMIDE
OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
OPTIRAY 240, IOVERSOL
OPTIRAY 300, IOVERSOL
OPTIRAY 320, IOVERSOL
OPTIRAY 350, IOVERSOL
OPTISON, ALBUMIN HUMAN
OPTIVAR, AZELASTINE HYDROCHLORIDE
ORABASE HCA, HYDROCORTISONE ACETATE
ORACEA, DOXYCYCLINE
ORAMORPH SR, MORPHINE SULFATE
ORAP, PIMOZIDE
ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE
ORAPRED, PREDNISOLONE SODIUM PHOSPHATE
ORAQIX, LIDOCAINE
ORAVERSE, PHENTOLAMINE MESYLATE
ORAVIG, MICONAZOLE
ORETIC, HYDROCHLOROTHIAZIDE
ORFADIN, NITISINONE
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

ORSYTHIA, ETHINYL ESTRADIOL
ORTHO CYCLEN-28, ETHINYL ESTRADIOL
ORTHO EVRA, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL
ORTHO-CEPT, DESOGESTREL
ORTHO-EST, ESTROPIPATE
ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL
ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL
ORVATEN, MIDODRINE HYDROCHLORIDE
OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 10% IN WATER, MANNITOL
OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 15% IN WATER, MANNITOL
OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 20% IN WATER, MANNITOL
OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 5% IN WATER, MANNITOL
OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
OTICAIR, HYDROCORTISONE
OVCON-35, ETHINYL ESTRADIOL
OVCON-50, ETHINYL ESTRADIOL
OVIDE, MALATHION
OVIDREL, CHORIOGONADOTROPIN ALFA
OXACILLIN SODIUM, OXACILLIN SODIUM
OXALIPLATIN, OXALIPLATIN
OXANDRIN, OXANDROLONE
OXANDROLONE, OXANDROLONE
OXAPROZIN, OXAPROZIN
OXAZEPAM, OXAZEPAM
OXCARBAZEPINE, OXCARBAZEPINE
OXECTA, OXYCODONE HYDROCHLORIDE
OXILAN-300, IOXILAN
OXILAN-350, IOXILAN
OXISTAT, OXICONAZOLE NITRATE
OXSORALEN, METHOXSALEN
OXSORALEN-ULTRA, METHOXSALEN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
OXYCET, ACETAMINOPHEN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE AND ASPIRIN, ASPIRIN
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYCONTIN, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
OXYTOCIN, OXYTOCIN
OXYTROL, OXYBUTYNIN
OZURDEX, DEXAMETHASONE

**
PACERONE, AMIODARONE HYDROCHLORIDE
PACLITAXEL, PACLITAXEL
PAMELOR, NORTRIPTYLINE HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PAMINE FORTE, METHSCOPOLAMINE BROMIDE
PAMINE, METHSCOPOLAMINE BROMIDE
PANCREAZE, LIPASE
PANCURONIUM BROMIDE, PANCURONIUM BROMIDE
PANDEL, HYDROCORTISONE PROBUTATE
PANRETIN, ALITRETINOIN
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PARAFON FORTE DSC, CHLORZOXAZONE

**

A - 40

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

PARAGARD T 380A, COPPER

PARCOPA, CARBIDOPA
PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE
PARICALCITOL, PARICALCITOL
PARLODEL, BROMOCRIPTINE MESYLATE
PARNATE, TRANYLCYPROMINE SULFATE
PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PASER, AMINOSALICYLIC ACID
PATADAY, OLOPATADINE HYDROCHLORIDE
PATANASE, OLOPATADINE HYDROCHLORIDE
PATANOL, OLOPATADINE HYDROCHLORIDE
PAXIL CR, PAROXETINE HYDROCHLORIDE
PAXIL, PAROXETINE HYDROCHLORIDE
PCE, ERYTHROMYCIN
PEDIAMYCIN 400, ERYTHROMYCIN ETHYLSUCCINATE
PEDIAMYCIN, ERYTHROMYCIN ETHYLSUCCINATE
PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE
PEDIATRIC ADVIL, IBUPROFEN (OTC)
PEDIOTIC, HYDROCORTISONE
PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL 3350
PEGANONE, ETHOTOIN
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
PENICILLIN G PROCAINE, PENICILLIN G PROCAINE
PENICILLIN G SODIUM, PENICILLIN G SODIUM
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PENICILLIN-VK, PENICILLIN V POTASSIUM
PENLAC, CICLOPIROX
PENNSAID, DICLOFENAC SODIUM
PENTAM, PENTAMIDINE ISETHIONATE
PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE
PENTASA, MESALAMINE
PENTAZOCINE AND NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
PENTAZOCINE AND NALOXONE HYDROCHLORIDES, NALOXONE HYDROCHLORIDE
PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE
PENTOSTATIN, PENTOSTATIN
PENTOXIFYLLINE, PENTOXIFYLLINE
PENTOXIL, PENTOXIFYLLINE
PEPCID AC (GELTAB), FAMOTIDINE (OTC)
PEPCID AC, FAMOTIDINE (OTC)
PEPCID COMPLETE, CALCIUM CARBONATE (OTC)
PEPCID, FAMOTIDINE
PERCOCET, ACETAMINOPHEN
PERCODAN, ASPIRIN
PERFOROMIST, FORMOTEROL FUMARATE
PERIDEX, CHLORHEXIDINE GLUCONATE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
PERIOCHIP, CHLORHEXIDINE GLUCONATE
PERIOGARD, CHLORHEXIDINE GLUCONATE
PERIOSTAT, DOXYCYCLINE HYCLATE
PERMAPEN, PENICILLIN G BENZATHINE
PERMETHRIN, PERMETHRIN
PERMETHRIN, PERMETHRIN (OTC)
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
PERPHENAZINE, PERPHENAZINE
PERSANTINE, DIPYRIDAMOLE
PEXEVA, PAROXETINE MESYLATE
PFIZERPEN, PENICILLIN G POTASSIUM
PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE (OTC)
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PHENELZINE SULFATE, PHENELZINE SULFATE

A - 41

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

A - 42

**

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PHENTERMINE RESIN COMPLEX, PHENTERMINE RESIN COMPLEX
PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
PHENYTEK, PHENYTOIN SODIUM
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PHENYTOIN, PHENYTOIN
PHILITH, ETHINYL ESTRADIOL
PHISOHEX, HEXACHLOROPHENE
PHOSLO GELCAPS, CALCIUM ACETATE
PHOSLYRA, CALCIUM ACETATE
PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE
PHOTOFRIN, PORFIMER SODIUM
PHRENILIN FORTE, ACETAMINOPHEN
PHRENILIN WITH CAFFEINE AND CODEINE, ACETAMINOPHEN
PHRENILIN, ACETAMINOPHEN
PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PHYTONADIONE, PHYTONADIONE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PILOPINE HS, PILOCARPINE HYDROCHLORIDE
PINDOLOL, PINDOLOL
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
PIPERACILLIN, PIPERACILLIN SODIUM
PIROXICAM, PIROXICAM
PITOCIN, OXYTOCIN
PLAN B ONE-STEP, LEVONORGESTREL
PLAN B ONE-STEP, LEVONORGESTREL (OTC)
PLAN B, LEVONORGESTREL
PLAN B, LEVONORGESTREL (OTC)
PLAQUENIL, HYDROXYCHLOROQUINE SULFATE
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 56 IN PLASTIC CONTAINER, MAGNESIUM ACETATE TETRAHYDRATE
PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLASMA-LYTE R IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLAVIX, CLOPIDOGREL BISULFATE
PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLENDIL, FELODIPINE
PLETAL, CILOSTAZOL
PODOFILOX, PODOFILOX
POLOCAINE, MEPIVACAINE HYDROCHLORIDE
POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
POLYMYCIN B SULFATE, POLYMYXIN B SULFATE
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
POLY-PRED, NEOMYCIN SULFATE
POLY-RX, POLYMYXIN B SULFATE
POLYTRIM, POLYMYXIN B SULFATE
PONSTEL, MEFENAMIC ACID
PORTIA-28, ETHINYL ESTRADIOL
POTASSIUM ACETATE IN PLASTIC CONTAINER, POTASSIUM ACETATE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
DEXTROSE
POTASSIUM
POTASSIUM
DEXTROSE
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM
CHLORIDE
POTASSIUM
POTASSIUM
POTASSIUM

CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE

0.037%
0.037%
0.037%
0.075%
0.075%

IN
IN
IN
IN
IN

DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE

A - 43

**

5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE
CHLORIDE

0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE
0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM

CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

A - 44

**

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
POTASSIUM CITRATE, POTASSIUM CITRATE
POTIGA, EZOGABINE
POVIDONE IODINE, POVIDONE-IODINE (OTC)
PRADAXA, DABIGATRAN ETEXILATE MESYLATE
PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRAMOSONE, HYDROCORTISONE ACETATE
PRANDIMET, METFORMIN HYDROCHLORIDE
PRANDIN, REPAGLINIDE
PRAVACHOL, PRAVASTATIN SODIUM
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE
PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE
PRECOSE, ACARBOSE
PRED FORTE, PREDNISOLONE ACETATE
PRED MILD, PREDNISOLONE ACETATE
PRED-G, GENTAMICIN SULFATE
PREDNICARBATE, PREDNICARBATE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE, PREDNISOLONE
PREDNISONE INTENSOL, PREDNISONE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

PREDNISONE, PREDNISONE
PREFEST, ESTRADIOL
PREGNYL, GONADOTROPIN, CHORIONIC
PRELONE, PREDNISOLONE
PREMARIN, ESTROGENS, CONJUGATED
PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS
PREMPHASE 14/14, ESTROGENS, CONJUGATED
PREMPRO, ESTROGENS, CONJUGATED
PRE-OP II, HEXACHLOROPHENE
PRE-OP, HEXACHLOROPHENE
PRE-PEN, BENZYLPENICILLOYL POLYLYSINE
PREPIDIL, DINOPROSTONE
PREVACID 24 HR, LANSOPRAZOLE (OTC)
PREVACID, LANSOPRAZOLE
PREVALITE, CHOLESTYRAMINE
PREVIFEM, ETHINYL ESTRADIOL
PREVPAC, AMOXICILLIN
PREZISTA, DARUNAVIR ETHANOLATE
PRIALT, ZICONOTIDE ACETATE
PRIFTIN, RIFAPENTINE
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE
PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE
PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC)
PRILOSEC, OMEPRAZOLE
PRILOSEC, OMEPRAZOLE MAGNESIUM
PRIMAQUINE, PRIMAQUINE PHOSPHATE
PRIMAXIN, CILASTATIN SODIUM
PRIMIDONE, PRIMIDONE
PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE
PRINIVIL, LISINOPRIL
PRINZIDE, HYDROCHLOROTHIAZIDE
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISTIQ, DESVENLAFAXINE SUCCINATE
PROAIR HFA, ALBUTEROL SULFATE
PROAMATINE, MIDODRINE HYDROCHLORIDE
PROBALAN, PROBENECID
PROBENECID AND COLCHICINE, COLCHICINE
PROBENECID, PROBENECID
PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE
PROCALAMINE, AMINO ACIDS
PROCARDIA XL, NIFEDIPINE
PROCARDIA, NIFEDIPINE
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE, PROCHLORPERAZINE
PROCOMP, PROCHLORPERAZINE MALEATE
PROCTOFOAM HC, HYDROCORTISONE ACETATE
PROFEN, IBUPROFEN (OTC)
PROFERDEX, IRON DEXTRAN
PROGESTERONE, PROGESTERONE
PROGLYCEM, DIAZOXIDE
PROGRAF, TACROLIMUS
PROHANCE MULTIPACK, GADOTERIDOL

A - 45

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APPENDIX A

PRODUCT NAME INDEX

**

A - 46

**

PROHANCE, GADOTERIDOL
PROMACTA, ELTROMBOPAG OLAMINE
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETH VC PLAIN, PHENYLEPHRINE HYDROCHLORIDE
PROMETH VC W/ CODEINE, CODEINE PHOSPHATE
PROMETH W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE
PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE
PROMETRIUM, PROGESTERONE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE
PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE
PROPECIA, FINASTERIDE
PROPINE, DIPIVEFRIN HYDROCHLORIDE
PROPOFOL, PROPOFOL
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROPYLTHIOURACIL, PROPYLTHIOURACIL
PROSCAR, FINASTERIDE
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
PROSTIN E2, DINOPROSTONE
PROSTIN VR PEDIATRIC, ALPROSTADIL
PROTAMINE SULFATE, PROTAMINE SULFATE
PROTONIX IV, PANTOPRAZOLE SODIUM
PROTONIX, PANTOPRAZOLE SODIUM
PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE
PROTOPIC, TACROLIMUS
PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
PROVENTIL-HFA, ALBUTEROL SULFATE
PROVERA, MEDROXYPROGESTERONE ACETATE
PROVIGIL, MODAFINIL
PROVOCHOLINE, METHACHOLINE CHLORIDE
PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE
PROZAC, FLUOXETINE HYDROCHLORIDE
PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
PULMICORT FLEXHALER, BUDESONIDE
PULMICORT RESPULES, BUDESONIDE
PULMICORT, BUDESONIDE
PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
PURINETHOL, MERCAPTOPURINE
PUR-WASH, PURIFIED WATER (OTC)
PYLERA, BISMUTH SUBCITRATE POTASSIUM
PYRAZINAMIDE, PYRAZINAMIDE
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE
PYTEST KIT, UREA, C-14
PYTEST, UREA, C-14

**

**

QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

QUALAQUIN, QUININE SULFATE
QUASENSE, ETHINYL ESTRADIOL
QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE
QUELICIN, SUCCINYLCHOLINE CHLORIDE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

**

**

QUINARETIC, HYDROCHLOROTHIAZIDE
QUINIDINE GLUCONATE, QUINIDINE GLUCONATE
QUINIDINE SULFATE, QUINIDINE SULFATE
QUIXIN, LEVOFLOXACIN
QUTENZA, CAPSAICIN
QVAR 40, BECLOMETHASONE DIPROPIONATE
QVAR 80, BECLOMETHASONE DIPROPIONATE

RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)

RAMIPRIL, RAMIPRIL
RANEXA, RANOLAZINE
RANICLOR, CEFACLOR
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RAPAFLO, SILODOSIN
RAPAMUNE, SIROLIMUS
RAZADYNE ER, GALANTAMINE HYDROBROMIDE
RAZADYNE, GALANTAMINE HYDROBROMIDE
REBETOL, RIBAVIRIN
RECLAST, ZOLEDRONIC ACID
RECTIV, NITROGLYCERIN
REFLUDAN, LEPIRUDIN RECOMBINANT
REGITINE, PHENTOLAMINE MESYLATE
REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
REGONOL, PYRIDOSTIGMINE BROMIDE
RELENZA, ZANAMIVIR
RELISTOR, METHYLNALTREXONE BROMIDE
RELPAX, ELETRIPTAN HYDROBROMIDE
REMERON SOLTAB, MIRTAZAPINE
REMERON, MIRTAZAPINE
REMODULIN, TREPROSTINIL SODIUM
RENACIDIN, CITRIC ACID
RENAGEL, SEVELAMER HYDROCHLORIDE
RENAMIN W/O ELECTROLYTES, AMINO ACIDS
RENOGRAFIN-76, DIATRIZOATE MEGLUMINE
RENOVA, TRETINOIN
RENVELA, SEVELAMER CARBONATE
REPREXAIN, HYDROCODONE BITARTRATE
REPRONEX, LUTEINIZING HORMONE
REQUIP XL, ROPINIROLE HYDROCHLORIDE
REQUIP, ROPINIROLE HYDROCHLORIDE
RESCRIPTOR, DELAVIRDINE MESYLATE
RESECTISOL IN PLASTIC CONTAINER, MANNITOL
RESERPINE, RESERPINE
RESTASIS, CYCLOSPORINE
RESTORIL, TEMAZEPAM
RETIN-A MICRO, TRETINOIN
RETIN-A, TRETINOIN
RETISERT, FLUOCINOLONE ACETONIDE
RETROVIR, ZIDOVUDINE
REVATIO, SILDENAFIL CITRATE
REVIA, NALTREXONE HYDROCHLORIDE
REVLIMID, LENALIDOMIDE
REYATAZ, ATAZANAVIR SULFATE
REZIRA, HYDROCODONE BITARTRATE
R-GENE 10, ARGININE HYDROCHLORIDE
RHINOCORT, BUDESONIDE
RIBASPHERE, RIBAVIRIN
RIBAVARIN, RIBAVIRIN
RIBAVIRIN, RIBAVIRIN
RID MOUSSE, PIPERONYL BUTOXIDE (OTC)
RIDAURA, AURANOFIN

A - 47

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

RIFADIN, RIFAMPIN
RIFAMATE, ISONIAZID
RIFAMPIN AND ISONIAZID, ISONIAZID
RIFAMPIN, RIFAMPIN
RIFATER, ISONIAZID
RILUTEK, RILUZOLE
RILUZOLE, RILUZOLE
RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE
RIMSO-50, DIMETHYL SULFOXIDE
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
RIOMET, METFORMIN HYDROCHLORIDE
RISEDRONATE SODIUM, RISEDRONATE SODIUM
RISPERDAL CONSTA, RISPERIDONE
RISPERDAL, RISPERIDONE
RISPERIDONE, RISPERIDONE
RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE
RITALIN, METHYLPHENIDATE HYDROCHLORIDE
RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
ROBAXIN, METHOCARBAMOL
ROBAXIN-750, METHOCARBAMOL
ROBINUL FORTE, GLYCOPYRROLATE
ROBINUL, GLYCOPYRROLATE
ROCALTROL, CALCITRIOL
ROCEPHIN, CEFTRIAXONE SODIUM
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
ROGAINE (FOR MEN), MINOXIDIL (OTC)
ROGAINE (FOR WOMEN), MINOXIDIL (OTC)
ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
ROMAZICON, FLUMAZENIL
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ROWASA, MESALAMINE
ROXICET 5/500, ACETAMINOPHEN
ROXICET, ACETAMINOPHEN
ROXICODONE, OXYCODONE HYDROCHLORIDE
ROXILOX, ACETAMINOPHEN
ROZEREM, RAMELTEON
RYTHMOL SR, PROPAFENONE HYDROCHLORIDE
RYTHMOL, PROPAFENONE HYDROCHLORIDE
RYZOLT, TRAMADOL HYDROCHLORIDE

**
SABRIL, VIGABATRIN
SAFYRAL, DROSPIRENONE
SAIZEN, SOMATROPIN RECOMBINANT
SALAGEN, PILOCARPINE HYDROCHLORIDE
SALONPAS, MENTHOL (OTC)
SALURON, HYDROFLUMETHIAZIDE
SAMSCA, TOLVAPTAN
SANCTURA XR, TROSPIUM CHLORIDE
SANCTURA, TROSPIUM CHLORIDE
SANCUSO, GRANISETRON
SANDIMMUNE, CYCLOSPORINE
SANDOSTATIN LAR, OCTREOTIDE ACETATE
SANDOSTATIN, OCTREOTIDE ACETATE
SAPHRIS, ASENAPINE MALEATE
SARAFEM, FLUOXETINE HYDROCHLORIDE
SAVELLA, MILNACIPRAN HYDROCHLORIDE
SCANDONEST L, LEVONORDEFRIN
SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE
SCANLUX-300, IOPAMIDOL
SCANLUX-370, IOPAMIDOL
SCLEROSOL, TALC

**

A - 48

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

SEASONALE, ETHINYL ESTRADIOL

SEASONIQUE, ETHINYL ESTRADIOL
SECONAL SODIUM, SECOBARBITAL SODIUM
SECTRAL, ACEBUTOLOL HYDROCHLORIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
SELENIUM SULFIDE, SELENIUM SULFIDE
SELSUN, SELENIUM SULFIDE
SELZENTRY, MARAVIROC
SEMPREX-D, ACRIVASTINE
SENSIPAR, CINACALCET HYDROCHLORIDE
SENSORCAINE, BUPIVACAINE HYDROCHLORIDE
SEPTOCAINE, ARTICAINE HYDROCHLORIDE
SEPTRA DS, SULFAMETHOXAZOLE
SEPTRA, SULFAMETHOXAZOLE
SEREVENT, SALMETEROL XINAFOATE
SEROMYCIN, CYCLOSERINE
SEROPHENE, CLOMIPHENE CITRATE
SEROQUEL XR, QUETIAPINE FUMARATE
SEROQUEL, QUETIAPINE FUMARATE
SEROSTIM, SOMATROPIN RECOMBINANT
SERPALAN, RESERPINE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SEVOFLURANE, SEVOFLURANE
SFROWASA, MESALAMINE
SHADE UVAGUARD, AVOBENZONE (OTC)
SILENOR, DOXEPIN HYDROCHLORIDE
SILVADENE, SILVER SULFADIAZINE
SIMCOR, NIACIN
SIMVASTATIN, SIMVASTATIN
SINE-AID IB, IBUPROFEN (OTC)
SINEMET CR, CARBIDOPA
SINEMET, CARBIDOPA
SINGULAIR, MONTELUKAST SODIUM
SINOGRAFIN, DIATRIZOATE MEGLUMINE
SKELAXIN, METAXALONE
SKELID, TILUDRONATE DISODIUM
SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS
SODIUM BICARBONATE, SODIUM BICARBONATE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, SODIUM FERRIC GLUCONATE COMPLEX
SODIUM IODIDE I 123, SODIUM IODIDE I-123
SODIUM IODIDE I 131, SODIUM IODIDE I-131
SODIUM IODIDE I-131, SODIUM IODIDE I-131
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE
SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
SOJOURN, SEVOFLURANE
SOLAGE, MEQUINOL
SOLARAZE, DICLOFENAC SODIUM
SOLODYN, MINOCYCLINE HYDROCHLORIDE
SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE
SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE
SOMA COMPOUND W/ CODEINE, ASPIRIN
SOMA COMPOUND, ASPIRIN
SOMA, CARISOPRODOL

A - 49

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

SOMATULINE DEPOT, LANREOTIDE ACETATE

SOMAVERT, PEGVISOMANT
SONATA, ZALEPLON
SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL
SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL
SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL
SORIATANE, ACITRETIN
SORILUX, CALCIPOTRIENE
SORINE, SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SOTRADECOL, SODIUM TETRADECYL SULFATE
SOTRET, ISOTRETINOIN
SPECTRACEF, CEFDITOREN PIVOXIL
SPIRIVA, TIOTROPIUM BROMIDE MONOHYDRATE
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
SPIRONOLACTONE, SPIRONOLACTONE
SPORANOX, ITRACONAZOLE
SPRINTEC, ETHINYL ESTRADIOL
SPRIX, KETOROLAC TROMETHAMINE
SPRYCEL, DASATINIB
SPS, SODIUM POLYSTYRENE SULFONATE
SSD AF, SILVER SULFADIAZINE
SSD, SILVER SULFADIAZINE
STADOL PRESERVATIVE FREE, BUTORPHANOL TARTRATE
STADOL, BUTORPHANOL TARTRATE
STALEVO 100, CARBIDOPA
STALEVO 125, CARBIDOPA
STALEVO 150, CARBIDOPA
STALEVO 200, CARBIDOPA
STALEVO 50, CARBIDOPA
STALEVO 75, CARBIDOPA
STARLIX, NATEGLINIDE
STAVUDINE, STAVUDINE
STAVZOR, VALPROIC ACID
STAXYN, VARDENAFIL HYDROCHLORIDE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
STERILE WATER, STERILE WATER FOR IRRIGATION
STIE-CORT, HYDROCORTISONE
STIMATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
STRATTERA, ATOMOXETINE HYDROCHLORIDE
STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE
STRIANT, TESTOSTERONE
STROMECTOL, IVERMECTIN
STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89
SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE
SUBOXONE, BUPRENORPHINE
SUBOXONE, BUPRENORPHINE HYDROCHLORIDE
SUBUTEX, BUPRENORPHINE HYDROCHLORIDE
SUCRAID, SACROSIDASE
SUCRALFATE, SUCRALFATE
SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE
SUFENTANIL CITRATE, SUFENTANIL CITRATE
SULAR, NISOLDIPINE
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
SULFADIAZINE, SULFADIAZINE
SULFAMETHOPRIM, SULFAMETHOXAZOLE
SULFAMETHOPRIM-DS, SULFAMETHOXAZOLE
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH, SULFAMETHOXAZOLE

A - 50

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SULFAMYLON, MAFENIDE ACETATE
SULFASALAZINE, SULFASALAZINE
SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE
SULINDAC, SULINDAC
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
SUMAVEL DOSEPRO, SUMATRIPTAN SUCCINATE
SUPPRELIN LA, HISTRELIN ACETATE
SUPRANE, DESFLURANE
SUPRAX, CEFIXIME
SUPRENZA, PHENTERMINE HYDROCHLORIDE
SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE ANHYDROUS
SURMONTIL, TRIMIPRAMINE MALEATE
SURVANTA, BERACTANT
SUSTIVA, EFAVIRENZ
SUTENT, SUNITINIB MALATE
SYEDA, DROSPIRENONE
SYMBICORT, BUDESONIDE
SYMBYAX, FLUOXETINE HYDROCHLORIDE
SYMLIN, PRAMLINTIDE ACETATE
SYNACORT, HYDROCORTISONE
SYNALAR, FLUOCINOLONE ACETONIDE
SYNALGOS-DC, ASPIRIN
SYNAREL, NAFARELIN ACETATE
SYNERA, LIDOCAINE
SYNERCID, DALFOPRISTIN
SYNTHETIC CONJUGATED ESTROGENS A, ESTROGENS, CONJUGATED SYNTHETIC A
SYNTHROID, LEVOTHYROXINE SODIUM
SYPRINE, TRIENTINE HYDROCHLORIDE

**

**

TAB-PROFEN, IBUPROFEN (OTC)

TACLONEX SCALP, BETAMETHASONE DIPROPIONATE
TACLONEX, BETAMETHASONE DIPROPIONATE
TACROLIMUS, TACROLIMUS
TAGAMET HB, CIMETIDINE (OTC)
TAGAMET, CIMETIDINE
TALC, TALC
TALWIN, PENTAZOCINE LACTATE
TAMBOCOR, FLECAINIDE ACETATE
TAMIFLU, OSELTAMIVIR PHOSPHATE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TAPAZOLE, METHIMAZOLE
TARCEVA, ERLOTINIB HYDROCHLORIDE
TARGRETIN, BEXAROTENE
TARKA, TRANDOLAPRIL
TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE
TASMAR, TOLCAPONE
TAVIST ALLERGY/SINUS/HEADACHE, ACETAMINOPHEN (OTC)
TAVIST-1, CLEMASTINE FUMARATE (OTC)
TAXOTERE, DOCETAXEL
TAZICEF, CEFTAZIDIME
TAZORAC, TAZAROTENE
TAZTIA XT, DILTIAZEM HYDROCHLORIDE
TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT
TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT
TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
TECHNETIUM TC-99 SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT

A - 51

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

TEFLARO, CEFTAROLINE FOSAMIL

TEGRETOL, CARBAMAZEPINE
TEGRETOL-XR, CARBAMAZEPINE
TEKAMLO, ALISKIREN HEMIFUMARATE
TEKTURNA HCT, ALISKIREN HEMIFUMARATE
TEKTURNA, ALISKIREN HEMIFUMARATE
TEMAZEPAM, TEMAZEPAM
TEMODAR, TEMOZOLOMIDE
TEMOVATE E, CLOBETASOL PROPIONATE
TEMOVATE, CLOBETASOL PROPIONATE
TEMOZOLOMIDE, TEMOZOLOMIDE
TENEX, GUANFACINE HYDROCHLORIDE
TENORETIC 100, ATENOLOL
TENORETIC 50, ATENOLOL
TENORMIN, ATENOLOL
TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE
TENSILON, EDROPHONIUM CHLORIDE
TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE
TENUATE, DIETHYLPROPION HYDROCHLORIDE
TERAZOL 3, TERCONAZOLE
TERAZOL 7, TERCONAZOLE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC)
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TERCONAZOLE, TERCONAZOLE
TERIL, CARBAMAZEPINE
TERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINE HYDROCHLORIDE
TESSALON, BENZONATATE
TESTIM, TESTOSTERONE
TESTOPEL, TESTOSTERONE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
TESTRED, METHYLTESTOSTERONE
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
TEVETEN HCT, EPROSARTAN MESYLATE
TEVETEN, EPROSARTAN MESYLATE
TEV-TROPIN, SOMATROPIN RECOMBINANT
TEXACORT, HYDROCORTISONE
THALITONE, CHLORTHALIDONE
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
THALOMID, THALIDOMIDE
THAM, TROMETHAMINE
THEO-24, THEOPHYLLINE
THEOCHRON, THEOPHYLLINE
THEOLAIR, THEOPHYLLINE
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE, THEOPHYLLINE
THERMAZENE, SILVER SULFADIAZINE
THEROXIDIL, MINOXIDIL (OTC)
THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE
THIOGUANINE, THIOGUANINE
THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE
THIOTEPA, THIOTEPA
THIOTHIXENE, THIOTHIXENE
THRIVE, NICOTINE POLACRILEX (OTC)
THYROGEN, THYROTROPIN ALFA
THYROLAR-0.25, LIOTHYRONINE SODIUM

A - 52

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

THYROLAR-0.5, LIOTHYRONINE SODIUM

THYROLAR-1, LIOTHYRONINE SODIUM
THYROLAR-2, LIOTHYRONINE SODIUM
THYROLAR-3, LIOTHYRONINE SODIUM
THYROSAFE, POTASSIUM IODIDE (OTC)
THYROSHIELD, POTASSIUM IODIDE (OTC)
TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE
TIAZAC, DILTIAZEM HYDROCHLORIDE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
TIKOSYN, DOFETILIDE
TIMENTIN IN PLASTIC CONTAINER, CLAVULANATE POTASSIUM
TIMENTIN, CLAVULANATE POTASSIUM
TIMOLOL MALEATE, TIMOLOL MALEATE
TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE
TIMOPTIC, TIMOLOL MALEATE
TIMOPTIC-XE, TIMOLOL MALEATE
TINDAMAX, TINIDAZOLE
TIOCONAZOLE, TIOCONAZOLE (OTC)
TIOPRONIN, TIOPRONIN
TIROSINT, LEVOTHYROXINE SODIUM
TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE
TIS-U-SOL, MAGNESIUM SULFATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOBI, TOBRAMYCIN
TOBRADEX ST, DEXAMETHASONE
TOBRADEX, DEXAMETHASONE
TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE
TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TOBRAMYCIN, TOBRAMYCIN
TOBREX, TOBRAMYCIN
TODAY, NONOXYNOL-9 (OTC)
TOFRANIL, IMIPRAMINE HYDROCHLORIDE
TOFRANIL-PM, IMIPRAMINE PAMOATE
TOLAZAMIDE, TOLAZAMIDE
TOLBUTAMIDE, TOLBUTAMIDE
TOLMETIN SODIUM, TOLMETIN SODIUM
TOPAMAX, TOPIRAMATE
TOPICORT LP, DESOXIMETASONE
TOPICORT, DESOXIMETASONE
TOPIRAMATE, TOPIRAMATE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
TOPOTECAN, TOPOTECAN HYDROCHLORIDE
TOPROL-XL, METOPROLOL SUCCINATE
TORISEL, TEMSIROLIMUS
TORSEMIDE, TORSEMIDE
TOTECT, DEXRAZOXANE HYDROCHLORIDE
TOVIAZ, FESOTERODINE FUMARATE
TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE
TRACLEER, BOSENTAN
TRADJENTA, LINAGLIPTIN
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRANDATE, LABETALOL HYDROCHLORIDE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL
TRANDOLAPRIL, TRANDOLAPRIL
TRANEXAMIC ACID, TRANEXAMIC ACID
TRANSDERM SCOP, SCOPOLAMINE
TRANXENE, CLORAZEPATE DIPOTASSIUM
TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE
TRASYLOL, APROTININ

A - 53

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 10% W/O ELECTROLYTES, AMINO ACIDS
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 3.5% W/ ELECTROLYTES, AMINO ACIDS
TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% W/ ELECTROLYTES, AMINO ACIDS
TRAVASOL 5.5% W/O ELECTROLYTES, AMINO ACIDS
TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% W/ ELECTROLYTES, AMINO ACIDS
TRAVASOL 8.5% W/O ELECTROLYTES, AMINO ACIDS
TRAVATAN Z, TRAVOPROST
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TREANDA, BENDAMUSTINE HYDROCHLORIDE
TRECATOR, ETHIONAMIDE
TRELSTAR, TRIPTORELIN PAMOATE
TRENTAL, PENTOXIFYLLINE
TRETINOIN, TRETINOIN
TREXALL, METHOTREXATE SODIUM
TREXIMET, NAPROXEN SODIUM
TRI LO SPRINTEC, ETHINYL ESTRADIOL
TRIACET, TRIAMCINOLONE ACETONIDE
TRIACIN-C, CODEINE PHOSPHATE
TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TRIAZOLAM, TRIAZOLAM
TRIBENZOR, AMLODIPINE BESYLATE
TRICOR, FENOFIBRATE
TRIDERM, TRIAMCINOLONE ACETONIDE
TRIDIONE, TRIMETHADIONE
TRIESENCE, TRIAMCINOLONE ACETONIDE
TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE
TRIFLURIDINE, TRIFLURIDINE
TRIGLIDE, FENOFIBRATE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
TRI-LEGEST 21, ETHINYL ESTRADIOL
TRI-LEGEST FE, ETHINYL ESTRADIOL
TRILEPTAL, OXCARBAZEPINE
TRILIPIX, CHOLINE FENOFIBRATE
TRI-LUMA, FLUOCINOLONE ACETONIDE
TRILYTE, POLYETHYLENE GLYCOL 3350
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
TRIMETHOPRIM, TRIMETHOPRIM
TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE
TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL
TRIOSTAT, LIOTHYRONINE SODIUM
TRI-PREVIFEM, ETHINYL ESTRADIOL
TRISENOX, ARSENIC TRIOXIDE
TRI-SPRINTEC, ETHINYL ESTRADIOL
TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)
TRIVARIS, TRIAMCINOLONE ACETONIDE
TRIVORA-28, ETHINYL ESTRADIOL
TRIZIVIR, ABACAVIR SULFATE
TROPHAMINE 10%, AMINO ACIDS
TROPHAMINE, AMINO ACIDS
TROPICACYL, TROPICAMIDE
TROPICAMIDE, TROPICAMIDE
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
TRUSOPT, DORZOLAMIDE HYDROCHLORIDE

A - 54

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

TRUVADA, EMTRICITABINE
TUSSICAPS, CHLORPHENIRAMINE POLISTIREX
TUSSIGON, HOMATROPINE METHYLBROMIDE
TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX
TWINJECT 0.15, EPINEPHRINE
TWINJECT 0.3, EPINEPHRINE
TWYNSTA, AMLODIPINE BESYLATE
TYGACIL, TIGECYCLINE
TYKERB, LAPATINIB DITOSYLATE
TYLENOL (CAPLET), ACETAMINOPHEN (OTC)
TYLENOL (GELTAB), ACETAMINOPHEN (OTC)
TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN
TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN
TYLOX, ACETAMINOPHEN
TYVASO, TREPROSTINIL SODIUM
TYZEKA, TELBIVUDINE
TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE

**

**

U-CORT, HYDROCORTISONE ACETATE

ULESFIA, BENZYL ALCOHOL
ULORIC, FEBUXOSTAT
ULTANE, SEVOFLURANE
ULTIVA, REMIFENTANIL HYDROCHLORIDE
ULTRACET, ACETAMINOPHEN
ULTRAM ER, TRAMADOL HYDROCHLORIDE
ULTRAM, TRAMADOL HYDROCHLORIDE
ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT
ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
ULTRAVATE, HALOBETASOL PROPIONATE
ULTRAVIST (PHARMACY BULK), IOPROMIDE
ULTRAVIST 150, IOPROMIDE
ULTRAVIST 240, IOPROMIDE
ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE
ULTRAVIST 300, IOPROMIDE
ULTRAVIST 370, IOPROMIDE
UNASYN, AMPICILLIN SODIUM
UNIRETIC, HYDROCHLOROTHIAZIDE
UNISOM, DOXYLAMINE SUCCINATE (OTC)
UNITHROID, LEVOTHYROXINE SODIUM
UNIVASC, MOEXIPRIL HYDROCHLORIDE
URECHOLINE, BETHANECHOL CHLORIDE
UREX, METHENAMINE HIPPURATE
UROCIT-K, POTASSIUM CITRATE
UROXATRAL, ALFUZOSIN HYDROCHLORIDE
URSO 250, URSODIOL
URSO FORTE, URSODIOL
URSODIOL, URSODIOL
UVADEX, METHOXSALEN

**

**

VAGIFEM, ESTRADIOL
VAGISTAT-1, TIOCONAZOLE (OTC)
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALCYTE, VALGANCICLOVIR HYDROCHLORIDE
VALIUM, DIAZEPAM
VALNAC, BETAMETHASONE VALERATE
VALPROATE SODIUM, VALPROATE SODIUM
VALPROIC ACID, VALPROIC ACID
VALSTAR PRESERVATIVE FREE, VALRUBICIN
VALTREX, VALACYCLOVIR HYDROCHLORIDE
VALTROPIN, SOMATROPIN RECOMBINANT

A - 55

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

VALTURNA, ALISKIREN HEMIFUMARATE

VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE
VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VANDAZOLE, METRONIDAZOLE
VANDETANIB, VANDETANIB
VANIQA, EFLORNITHINE HYDROCHLORIDE
VANOS, FLUOCINONIDE
VANTAS, HISTRELIN ACETATE
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE
VASERETIC, ENALAPRIL MALEATE
VASOCIDIN, PREDNISOLONE SODIUM PHOSPHATE
VASOTEC, ENALAPRIL MALEATE
VECTICAL, CALCITRIOL
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VELCADE, BORTEZOMIB
VELETRI, EPOPROSTENOL SODIUM
VELIVET, DESOGESTREL
VELTIN, CLINDAMYCIN PHOSPHATE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VENOFER, IRON SUCROSE
VENTAVIS, ILOPROST
VENTOLIN HFA, ALBUTEROL SULFATE
VERAMYST, FLUTICASONE FUROATE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
VERDESO, DESONIDE
VEREGEN, SINECATECHINS
VERELAN PM, VERAPAMIL HYDROCHLORIDE
VERELAN, VERAPAMIL HYDROCHLORIDE
VESICARE, SOLIFENACIN SUCCINATE
VEXOL, RIMEXOLONE
VFEND, VORICONAZOLE
VIAGRA, SILDENAFIL CITRATE
VIBATIV, TELAVANCIN HYDROCHLORIDE
VIBISONE, CYANOCOBALAMIN
VIBRAMYCIN, DOXYCYCLINE
VIBRAMYCIN, DOXYCYCLINE CALCIUM
VIBRAMYCIN, DOXYCYCLINE HYCLATE
VICODIN ES, ACETAMINOPHEN
VICODIN HP, ACETAMINOPHEN
VICODIN, ACETAMINOPHEN
VICOPROFEN, HYDROCODONE BITARTRATE
VICTOZA, LIRAGLUTIDE RECOMBINANT
VICTRELIS, BOCEPREVIR
VIDAZA, AZACITIDINE
VIDEX EC, DIDANOSINE
VIDEX, DIDANOSINE
VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE
VIIBRYD, VILAZODONE HYDROCHLORIDE
VIMOVO, ESOMEPRAZOLE MAGNESIUM
VIMPAT, LACOSAMIDE
VINBLASTINE SULFATE, VINBLASTINE SULFATE
VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
VIRACEPT, NELFINAVIR MESYLATE
VIRAMUNE XR, NEVIRAPINE
VIRAMUNE, NEVIRAPINE
VIRAZOLE, RIBAVIRIN
VIREAD, TENOFOVIR DISOPROXIL FUMARATE
VIROPTIC, TRIFLURIDINE
VISICOL, SODIUM PHOSPHATE, DIBASIC ANHYDROUS
VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)
VISINE-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

A - 56

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

**

**

**

**

VISIONBLUE, TRYPAN BLUE

VISIPAQUE 270, IODIXANOL
VISIPAQUE 320, IODIXANOL
VISTARIL, HYDROXYZINE PAMOATE
VISTIDE, CIDOFOVIR
VISUDYNE, VERTEPORFIN
VITAMIN D, ERGOCALCIFEROL
VITAMIN K1, PHYTONADIONE
VITRASE, HYALURONIDASE
VITRASERT, GANCICLOVIR
VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE
VIVELLE, ESTRADIOL
VIVELLE-DOT, ESTRADIOL
VIVITROL, NALTREXONE
VOLTAREN, DICLOFENAC SODIUM
VOLTAREN-XR, DICLOFENAC SODIUM
VORICONAZOLE, VORICONAZOLE
VOSOL HC, ACETIC ACID, GLACIAL
VOSOL, ACETIC ACID, GLACIAL
VOSPIRE ER, ALBUTEROL SULFATE
VOTRIENT, PAZOPANIB HYDROCHLORIDE
VPRIV, VELAGLUCERASE ALFA
VUMON, TENIPOSIDE
VUSION, MICONAZOLE NITRATE
VYTORIN, EZETIMIBE
VYVANSE, LISDEXAMFETAMINE DIMESYLATE

WARFARIN SODIUM, WARFARIN SODIUM

WELCHOL, COLESEVELAM HYDROCHLORIDE
WELLBUTRIN SR, BUPROPION HYDROCHLORIDE
WELLBUTRIN XL, BUPROPION HYDROCHLORIDE
WELLBUTRIN, BUPROPION HYDROCHLORIDE
WESTCORT, HYDROCORTISONE VALERATE

XALATAN, LATANOPROST
XALKORI, CRIZOTINIB
XANAX XR, ALPRAZOLAM
XANAX, ALPRAZOLAM
XARELTO, RIVAROXABAN
XELODA, CAPECITABINE
XENAZINE, TETRABENAZINE
XENICAL, ORLISTAT
XENON XE 133, XENON XE-133
XERESE, ACYCLOVIR
XIFAXAN, RIFAXIMIN
XOLEGEL, KETOCONAZOLE
XOPENEX HFA, LEVALBUTEROL TARTRATE
XOPENEX, LEVALBUTEROL HYDROCHLORIDE
XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE DENTAL WITH EPINEPHRINE, EPINEPHRINE
XYLOCAINE DENTAL, LIDOCAINE HYDROCHLORIDE
XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE
XYLOCAINE, LIDOCAINE HYDROCHLORIDE
XYREM, SODIUM OXYBATE
XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE

**
YASMIN, DROSPIRENONE

**

A - 57

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

**

**

YAZ, DROSPIRENONE

ZADITOR, KETOTIFEN FUMARATE (OTC)

ZAFIRLUKAST, ZAFIRLUKAST
ZALEPLON, ZALEPLON
ZANAFLEX, TIZANIDINE HYDROCHLORIDE
ZANOSAR, STREPTOZOCIN
ZANTAC 150, RANITIDINE HYDROCHLORIDE
ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC)
ZANTAC 25, RANITIDINE HYDROCHLORIDE
ZANTAC 300, RANITIDINE HYDROCHLORIDE
ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC)
ZANTAC IN PLASTIC CONTAINER, RANITIDINE HYDROCHLORIDE
ZANTAC, RANITIDINE HYDROCHLORIDE
ZARONTIN, ETHOSUXIMIDE
ZAROXOLYN, METOLAZONE
ZAVESCA, MIGLUSTAT
ZEBETA, BISOPROLOL FUMARATE
ZEGERID OTC, OMEPRAZOLE (OTC)
ZEGERID, OMEPRAZOLE
ZELAPAR, SELEGILINE HYDROCHLORIDE
ZELBORAF, VEMURAFENIB
ZEMPLAR, PARICALCITOL
ZEMURON, ROCURONIUM BROMIDE
ZENPEP, LIPASE
ZERIT, STAVUDINE
ZESTORETIC, HYDROCHLOROTHIAZIDE
ZESTRIL, LISINOPRIL
ZETIA, EZETIMIBE
ZIAC, BISOPROLOL FUMARATE
ZIAGEN, ABACAVIR SULFATE
ZIANA, CLINDAMYCIN PHOSPHATE
ZIDOVUDINE, ZIDOVUDINE
ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM
ZINACEF, CEFUROXIME SODIUM
ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE
ZINECARD, DEXRAZOXANE HYDROCHLORIDE
ZIPSOR, DICLOFENAC POTASSIUM
ZIRGAN, GANCICLOVIR
ZITHROMAX, AZITHROMYCIN
ZMAX, AZITHROMYCIN
ZOCOR, SIMVASTATIN
ZOFRAN ODT, ONDANSETRON
ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ZOFRAN, ONDANSETRON HYDROCHLORIDE
ZOLADEX, GOSERELIN ACETATE
ZOLINZA, VORINOSTAT
ZOLOFT, SERTRALINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZOLPIDEM TATRATE, ZOLPIDEM TARTRATE
ZOLPIMIST, ZOLPIDEM TARTRATE
ZOMETA, ZOLEDRONIC ACID
ZOMIG, ZOLMITRIPTAN
ZOMIG-ZMT, ZOLMITRIPTAN
ZONALON, DOXEPIN HYDROCHLORIDE
ZONEGRAN, ZONISAMIDE
ZONISAMIDE, ZONISAMIDE
ZORBTIVE, SOMATROPIN RECOMBINANT
ZORTRESS, EVEROLIMUS
ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM
ZOSYN, PIPERACILLIN SODIUM
ZOVIA 1/35E-28, ETHINYL ESTRADIOL

A - 58

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX A

PRODUCT NAME INDEX

**

**

ZOVIA 1/50E-28, ETHINYL ESTRADIOL

ZOVIRAX, ACYCLOVIR
ZUPLENZ, ONDANSETRON
ZUTRIPRO, CHLORPHENIRAMINE MALEATE
ZYBAN, BUPROPION HYDROCHLORIDE
ZYCLARA, IMIQUIMOD
ZYDONE, ACETAMINOPHEN
ZYFLO CR, ZILEUTON
ZYFLO, ZILEUTON
ZYLET, LOTEPREDNOL ETABONATE
ZYLOPRIM, ALLOPURINOL
ZYMAR, GATIFLOXACIN
ZYMAXID, GATIFLOXACIN
ZYPREXA RELPREVV, OLANZAPINE PAMOATE
ZYPREXA ZYDIS, OLANZAPINE
ZYPREXA, OLANZAPINE
ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC, CETIRIZINE HYDROCHLORIDE
ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)
ZYTIGA, ABIRATERONE ACETATE
ZYVOX, LINEZOLID

A - 59

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

3M
* 3M CO
PERIDEX, CHLORHEXIDINE GLUCONATE
* 3M HEALTH CARE INC
AVAGARD, ALCOHOL (OTC)

DURAPREP, IODINE POVACRYLEX (OTC)

* 3M PHARMACEUTICALS INC
PROVENTIL-HFA, ALBUTEROL SULFATE
3M INFECTION
* 3M INFECTION PREVENTION DIV
CHLORASCRUB MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORASCRUB SWAB, CHLORHEXIDINE GLUCONATE (OTC)

CHLORASCRUB SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

AAIPHARMA LLC
* AAIPHARMA LLC
AZASAN, AZATHIOPRINE
ABBOTT
* ABBOTT LABORATORIES
ADVICOR, LOVASTATIN
AKINETON, BIPERIDEN HYDROCHLORIDE
AZMACORT, TRIAMCINOLONE ACETONIDE
BIAXIN XL, CLARITHROMYCIN
BIAXIN, CLARITHROMYCIN
CYCLOSPORINE, CYCLOSPORINE
DEPAKOTE ER, DIVALPROEX SODIUM
DEPAKOTE, DIVALPROEX SODIUM
GENGRAF, CYCLOSPORINE
KALETRA, LOPINAVIR
NIASPAN, NIACIN
NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE
NIMBEX, CISATRACURIUM BESYLATE
NORVIR, RITONAVIR
SIMCOR, NIACIN
SYNTHROID, LEVOTHYROXINE SODIUM
TEVETEN HCT, EPROSARTAN MESYLATE
TEVETEN, EPROSARTAN MESYLATE
ULTANE, SEVOFLURANE

ZEMPLAR, PARICALCITOL

* ABBOTT LABORATORIES HOSP PRODUCTS DIV

CALCIJEX, CALCITRIOL
* ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
BIAXIN, CLARITHROMYCIN
DEPACON, VALPROATE SODIUM
DEPAKENE, VALPROIC ACID
DEPAKOTE, DIVALPROEX SODIUM
ENDURON, METHYCLOTHIAZIDE
HYTRIN, TERAZOSIN HYDROCHLORIDE
K-TAB, POTASSIUM CHLORIDE
MAVIK, TRANDOLAPRIL
NORVIR, RITONAVIR
ORETIC, HYDROCHLOROTHIAZIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
TARKA, TRANDOLAPRIL
TRIDIONE, TRIMETHADIONE
VICODIN ES, ACETAMINOPHEN
VICODIN HP, ACETAMINOPHEN
VICODIN, ACETAMINOPHEN
VICOPROFEN, HYDROCODONE BITARTRATE

ZEMPLAR, PARICALCITOL

ABBOTT ENDOCRINE
* ABBOTT ENDOCRINE INC
LUPRON DEPOT, LEUPROLIDE ACETATE

B - 1

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ABBOTT ENDOCRINE INC

LUPRON DEPOT-PED, LEUPROLIDE ACETATE
ABBOTT LABS
* ABBOTT ENDOCRINE INC SUB ABBOTT LABORATORIES
LUPRON DEPOT, LEUPROLIDE ACETATE
* ABBOTT LABORATORIES
ANDROGEL, TESTOSTERONE
NORVIR, RITONAVIR
PROMETRIUM, PROGESTERONE

TRILIPIX, CHOLINE FENOFIBRATE

ABBOTT LABS PHARM

* ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
TRICOR, FENOFIBRATE
ABBOTT PRODS
* ABBOTT PRODUCTS INC
ACEON, PERINDOPRIL ERBUMINE
CREON, LIPASE

MARINOL, DRONABINOL

ABRAXIS BIOSCIENCE
* ABRAXIS BIOSCIENCE LLC
ABRAXANE, PACLITAXEL
ABRAXIS PHARM
* ABRAXIS PHARMACEUTICAL PRODUCTS
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

ACADEMIC PHARMS
* ACADEMIC PHARMACEUTICALS INC
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
ACCORD HLTH
* ACCORD HEALTH CARE INC
METHYLDOPA, METHYLDOPA
ACCORD HLTHCARE
* ACCORD HEALTHCARE INC
DOCETAXEL, DOCETAXEL
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLIMEPIRIDE, GLIMEPIRIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
MITOMYCIN, MITOMYCIN
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
TACROLIMUS, TACROLIMUS

TOPIRAMATE, TOPIRAMATE

ACCORD HLTHCARE INC

* ACCORD HEALTHCARE INC USA
ANASTROZOLE, ANASTROZOLE
BICALUTAMIDE, BICALUTAMIDE
CLONAZEPAM, CLONAZEPAM
ETOPOSIDE, ETOPOSIDE
FINASTERIDE, FINASTERIDE
GLIPIZIDE, GLIPIZIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

PACLITAXEL, PACLITAXEL

ACIC FINE CHEMS

* ACIC FINE CHEMICALS INC
AMPICILLIN SODIUM, AMPICILLIN SODIUM

B - 2

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ACIC FINE CHEMICALS INC

NAFCILLIN SODIUM, NAFCILLIN SODIUM
ACORDA
* ACORDA THERAPEUTICS INC
AMPYRA, DALFAMPRIDINE

ZANAFLEX, TIZANIDINE HYDROCHLORIDE

ACS DOBFAR
* ACS DOBFAR SPA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE
CEFOXITIN, CEFOXITIN SODIUM
CEFTAZIDIME, CEFTAZIDIME
CEFTRIAXONE, CEFTRIAXONE SODIUM
IMIPENEM AND CILASTATIN, CILASTATIN SODIUM
KEFZOL, CEFAZOLIN SODIUM

MEROPENEM, MEROPENEM

ACS DOBFAR INFO SA

* ACS DOBFAR INFO SA
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
ACTAVIS
* ACTAVIS SOUTH ATLANTIC LLC
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
* ACTAVIS SOUTHATLANTIC LLC
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
NIFEDIPINE, NIFEDIPINE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

ACTAVIS ELIZABETH
* ACTAVIS ELIZABETH LLC
ALPRAZOLAM, ALPRAZOLAM
CARBIDOPA AND LEVODOPA, CARBIDOPA
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
GABAPENTIN, GABAPENTIN
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
INDAPAMIDE, INDAPAMIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
KADIAN, MORPHINE SULFATE
LEVETIRACETAM, LEVETIRACETAM
LORAZEPAM, LORAZEPAM
LOVASTATIN, LOVASTATIN
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
NIFEDIPINE, NIFEDIPINE
OXAZEPAM, OXAZEPAM
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROPYLTHIOURACIL, PROPYLTHIOURACIL
SPIRONOLACTONE, SPIRONOLACTONE

TEMAZEPAM, TEMAZEPAM

(OTC)

B - 3

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

ACTAVIS INC
* ACTAVIS INC
LOSARTAN POTASSIUM,

**

LOSARTAN POTASSIUM

ACTAVIS MID ATLANTIC

* ACTAVIS MID ATLANTIC LLC
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
ACETASOL HC, ACETIC ACID, GLACIAL
ACYCLOVIR, ACYCLOVIR
ALBUTEROL SULFATE, ALBUTEROL SULFATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CICLOPIROX, CICLOPIROX
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)
CONSTULOSE, LACTULOSE
ENULOSE, LACTULOSE
FLUOCINONIDE, FLUOCINONIDE
GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROCORTISONE, HYDROCORTISONE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
INFANTS' FEVERALL, ACETAMINOPHEN (OTC)
LEVETIRACETAM, LEVETIRACETAM
MICONAZOLE 7, MICONAZOLE NITRATE (OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
NYSTATIN, NYSTATIN
PERMETHRIN, PERMETHRIN
PERMETHRIN, PERMETHRIN (OTC)
PROMETH VC PLAIN, PHENYLEPHRINE HYDROCHLORIDE
PROMETH VC W/ CODEINE, CODEINE PHOSPHATE
PROMETH W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE

VALNAC, BETAMETHASONE VALERATE

ACTAVIS PHARMA
* ACTAVIS PHARMA MANUFACTURING PRIVATE LTD
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

ACTAVIS S ATLANTIC
* ACTAVIS SOUTH ATLANTIC LLC
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZOLPIDEM TATRATE, ZOLPIDEM TARTRATE

ACTAVIS TOTOWA
* ACTAVIS TOTOWA LLC
BICALUTAMIDE, BICALUTAMIDE
DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
LETROZOLE, LETROZOLE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

B - 4

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ACTAVIS TOTOWA LLC

PACLITAXEL, PACLITAXEL
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ACTELION
* ACTELION LTD
TRACLEER, BOSENTAN

VELETRI, EPOPROSTENOL SODIUM

ACTELION PHARMS LTD

* ACTELION PHARMACEUTICALS LTD
VENTAVIS, ILOPROST

ZAVESCA, MIGLUSTAT

ACTIENT PHARMS
* ACTIENT PHARMACEUTICALS LLC
STRIANT, TESTOSTERONE
ACTON PHARMS
* ACTON PHARMACEUTICALS INC
AEROSPAN HFA, FLUNISOLIDE
ADOLOR
* ADOLOR CORP
ENTEREG, ALVIMOPAN
ADVENT PHARMS
* ADVENT PHARMACEUTICALS INC
CARISOPRODOL, CARISOPRODOL
AEGIS PHARMS
* AEGIS PHARMACEUTICALS INC
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
AGOURON
* AGOURON PHARMACEUTICALS INC
VIRACEPT, NELFINAVIR MESYLATE
AJANTA PHARMA
* AJANTA PHARMA LTD
LEVETIRACETAM, LEVETIRACETAM
AJANTA PHARMA LTD
* AJANTA PHARMA LTD
RISPERIDONE, RISPERIDONE
AKORN
* AKORN INC
ADENOSINE, ADENOSINE
AKBETA, LEVOBUNOLOL HYDROCHLORIDE
AK-FLUOR 10%, FLUORESCEIN SODIUM
AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE
AKPRO, DIPIVEFRIN HYDROCHLORIDE
AKTEN, LIDOCAINE HYDROCHLORIDE
AKTOB, TOBRAMYCIN
ALFENTA, ALFENTANIL HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BAL, DIMERCAPROL
BALANCED SALT, CALCIUM CHLORIDE
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
CALCITRIOL, CALCITRIOL
CAPASTAT SULFATE, CAPREOMYCIN SULFATE
CARBOPLATIN, CARBOPLATIN
CROMOLYN SODIUM, CROMOLYN SODIUM
DICLOFENAC SODIUM, DICLOFENAC SODIUM

ENDOSOL EXTRA, CALCIUM CHLORIDE

B - 5

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A

**

* AKORN INC
ERYTHROMYCIN, ERYTHROMYCIN
GENTAK, GENTAMICIN SULFATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IC-GREEN, INDOCYANINE GREEN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)
LEVOFLOXACIN, LEVOFLOXACIN
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
OFLOXACIN, OFLOXACIN
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE
SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE
SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TIMOLOL MALEATE, TIMOLOL MALEATE

TROPICACYL, TROPICAMIDE

AKORN INC
* AKORN INC
APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HYDASE, HYALURONIDASE

INAPSINE, DROPERIDOL

AKORN STRIDES
* AKORN STRIDES LLC
TOBRAMYCIN SULFATE,

TOBRAMYCIN SULFATE

AKRIMAX PHARMS
* AKRIMAX PHARMACEUTICALS LLC
INDERAL LA, PROPRANOLOL HYDROCHLORIDE
INDERAL, PROPRANOLOL HYDROCHLORIDE

INDERIDE-40/25, HYDROCHLOROTHIAZIDE

ALARA PHARM
* ALARA PHARMACEUTICAL CORPORATION
LEVO-T, LEVOTHYROXINE SODIUM
ALCON
* ALCON INC
TRIESENCE, TRIAMCINOLONE ACETONIDE
* ALCON LABORATORIES INC
ALCAINE, PROPARACAINE HYDROCHLORIDE
ALOMIDE, LODOXAMIDE TROMETHAMINE
BETOPTIC S, BETAXOLOL HYDROCHLORIDE
BETOPTIC, BETAXOLOL HYDROCHLORIDE
BSS PLUS, CALCIUM CHLORIDE
BSS, CALCIUM CHLORIDE
CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE
CETAMIDE, SULFACETAMIDE SODIUM
CROMOLYN SODIUM, CROMOLYN SODIUM
CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE
CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE
DENDRID, IDOXURIDINE
EMADINE, EMEDASTINE DIFUMARATE
FLAREX, FLUOROMETHOLONE ACETATE
IOPIDINE, APRACLONIDINE HYDROCHLORIDE
MAXIDEX, DEXAMETHASONE
MAXITROL, DEXAMETHASONE

MIOSTAT, CARBACHOL

B - 6

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ALCON LABORATORIES INC

MYDRIACYL, TROPICAMIDE
NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
NATACYN, NATAMYCIN
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE,
OMNIPRED, PREDNISOLONE ACETATE
PATANOL, OLOPATADINE HYDROCHLORIDE
PILOPINE HS, PILOCARPINE HYDROCHLORIDE
TOBRADEX, DEXAMETHASONE
TOBREX, TOBRAMYCIN
TRIFLURIDINE, TRIFLURIDINE

VEXOL, RIMEXOLONE

ALCON PHARMA
* ALCON RESEARCH LTD
ZADITOR, KETOTIFEN FUMARATE

HYDROCORTISONE

(OTC)

ALCON PHARMS LTD

* ALCON PHARMACEUTICALS LTD
AZOPT, BRINZOLAMIDE
BETADINE, POVIDONE-IODINE
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
CILOXAN, CIPROFLOXACIN HYDROCHLORIDE
CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE
CIPRODEX, CIPROFLOXACIN
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
DUREZOL, DIFLUPREDNATE
FLUORESCITE, FLUORESCEIN SODIUM
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)
MOXEZA, MOXIFLOXACIN HYDROCHLORIDE
NAVSTEL, CALCIUM CHLORIDE
NEVANAC, NEPAFENAC
OFLOXACIN, OFLOXACIN
PATADAY, OLOPATADINE HYDROCHLORIDE
PATANASE, OLOPATADINE HYDROCHLORIDE
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE,
TOBRADEX ST, DEXAMETHASONE
TRAVATAN Z, TRAVOPROST

VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE

ALCON RES
* ALCON RESEARCH LTD
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE,
ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE

LATANOPROST, LATANOPROST

PREDNISOLONE SODIUM PHOSPHATE

DORZOLAMIDE HYDROCHLORIDE

ALCON UNIVERSAL
* ALCON UNIVERSAL LTD
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

ALDOPHARMA USA
* ALKOPHARMA USA INC
AMPHOTEC, AMPHOTERICIN B
ALEMBIC LTD
* ALEMBIC LTD
LITHIUM CARBONATE, LITHIUM CARBONATE
METRONIDAZOLE, METRONIDAZOLE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

B - 7

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

ALEMBIC PHARMS LTD

* ALEMBIC PHARMACEUTICALS LTD
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
FAMOTIDINE, FAMOTIDINE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LAMOTRIGINE, LAMOTRIGINE
LEFLUNOMIDE, LEFLUNOMIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEPROBAMATE, MEPROBAMATE
METRONIDAZOLE, METRONIDAZOLE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ALKEM
* ALKEM LABORATORIES LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CEPHALEXIN, CEPHALEXIN
GABAPENTIN, GABAPENTIN

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ALKEM LABS LTD

* ALKEM LABORATORIES LTD
CEFUROXIME AXETIL, CEFUROXIME AXETIL

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

ALKERMES
* ALKERMES INC
VIVITROL, NALTREXONE
ALKERMES GAINESVILLE
* ALKERMES GAINESVILLE LLC
VERELAN, VERAPAMIL HYDROCHLORIDE
ALLEGIANCE HLTHCARE
* ALLEGIANCE HEALTHCARE CORP
POVIDONE IODINE, POVIDONE-IODINE

(OTC)

ALLERGAN
* ALLERGAN
ACULAR LS, KETOROLAC TROMETHAMINE
ALPHAGAN P, BRIMONIDINE TARTRATE
BLEPH-10, SULFACETAMIDE SODIUM
GENOPTIC, GENTAMICIN SULFATE

ZYMAXID, GATIFLOXACIN

* ALLERGAN INC
ACULAR PRESERVATIVE FREE, KETOROLAC TROMETHAMINE
ACULAR, KETOROLAC TROMETHAMINE
ACUVAIL, KETOROLAC TROMETHAMINE
ACZONE, DAPSONE
ALBALON, NAPHAZOLINE HYDROCHLORIDE
ALOCRIL, NEDOCROMIL SODIUM
ALPHAGAN P, BRIMONIDINE TARTRATE
AVAGE, TAZAROTENE
AZELEX, AZELAIC ACID
COMBIGAN, BRIMONIDINE TARTRATE
ELESTAT, EPINASTINE HYDROCHLORIDE
ELIMITE, PERMETHRIN
LASTACAFT, ALCAFTADINE
LATISSE, BIMATOPROST
LUMIGAN, BIMATOPROST
OCUFLOX, OFLOXACIN
OPTICROM, CROMOLYN SODIUM
OZURDEX, DEXAMETHASONE
POLYTRIM, POLYMYXIN B SULFATE
RESTASIS, CYCLOSPORINE
SANCTURA XR, TROSPIUM CHLORIDE

SANCTURA, TROSPIUM CHLORIDE

B - 8

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A

**

* ALLERGAN INC
TAZORAC, TAZAROTENE
TRIVARIS, TRIAMCINOLONE ACETONIDE

ZYMAR, GATIFLOXACIN

* ALLERGAN PHARMACEUTICAL
BETAGAN, LEVOBUNOLOL HYDROCHLORIDE
BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE
BLEPHAMIDE, PREDNISOLONE ACETATE
FML FORTE, FLUOROMETHOLONE
FML, FLUOROMETHOLONE
HERPLEX, IDOXURIDINE
OCUFEN, FLURBIPROFEN SODIUM
OPHTHETIC, PROPARACAINE HYDROCHLORIDE
POLY-PRED, NEOMYCIN SULFATE
PRED FORTE, PREDNISOLONE ACETATE
PRED MILD, PREDNISOLONE ACETATE
PRED-G, GENTAMICIN SULFATE

PROPINE, DIPIVEFRIN HYDROCHLORIDE

ALLERGAN HERBERT
* ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC
FLUOROPLEX, FLUOROURACIL
ALLERQUEST
* ALLERQUEST LLC
PRE-PEN, BENZYLPENICILLOYL POLYLYSINE
ALLOS
* ALLOS THERAPEUTICS INC
FOLOTYN, PRALATREXATE
ALPHAPHARM
* ALPHAPHARM PARTY LTD
ALPRAZOLAM, ALPRAZOLAM
CILOSTAZOL, CILOSTAZOL
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLONAZEPAM, CLONAZEPAM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
INDAPAMIDE, INDAPAMIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
NAPROXEN, NAPROXEN
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRIAZOLAM, TRIAZOLAM

ZONISAMIDE, ZONISAMIDE

* ALPHAPHARM PTY LTD

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

ALPHARMA
* ALPHARMA USPD INC
PREDNISOLONE, PREDNISOLONE

VALPROIC ACID, VALPROIC ACID

ALPHARMA KING
* ALPHARMA PHARMACEUTICALS LLC KING PHARMACEUTICALS
EMBEDA, MORPHINE SULFATE
ALRA
* ALRA LABORATORIES INC
CHOLAC, LACTULOSE
CONSTILAC, LACTULOSE
GEN-XENE, CLORAZEPATE DIPOTASSIUM
IBU-TAB 200, IBUPROFEN (OTC)

IBU-TAB, IBUPROFEN

B - 9

B - 10

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

ALTAIRE PHARMS INC

* ALTAIRE PHARMACEUTICALS INC
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE,

NAPHAZOLINE HYDROCHLORIDE

ALTANA
* ALTANA INC
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
AMCINONIDE, AMCINONIDE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CUTIVATE, FLUTICASONE PROPIONATE
DESONIDE, DESONIDE
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
ECONAZOLE NITRATE, ECONAZOLE NITRATE
ERYTHROMYCIN, ERYTHROMYCIN
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE
HYDROCORTISONE, HYDROCORTISONE
KETOCONAZOLE, KETOCONAZOLE
METRONIDAZOLE, METRONIDAZOLE
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPIROCIN, MUPIROCIN
NYSTATIN, NYSTATIN
OXISTAT, OXICONAZOLE NITRATE
PREDNICARBATE, PREDNICARBATE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

ALTANA PHARMA
* ALTANA PHARMA AG
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE,
ALTERNA TCHP LLC
* ALTERNA TCHP LLC
CHILDREN'S ELIXSURE,

IBUPROFEN

BETAMETHASONE DIPROPIONATE

(OTC)

ALVOGEN
* ALVOGEN INC
MACROBID, NITROFURANTOIN
MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

ALVOGEN INC
* ALVOGEN INC
OXYCODONE HYDROCHLORIDE,

OXYCODONE HYDROCHLORIDE

AM ANTIBIOTICS
* AMERICAN ANTIBIOTICS LLC
AMOXICILLIN, AMOXICILLIN
AMAG PHARMS INC
* AMAG PHARMACEUTICALS INC
FERAHEME, FERUMOXYTOL
FERIDEX I.V., FERUMOXIDES

GASTROMARK, FERUMOXSIL

(OTC)

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

AMGEN
* AMGEN INC
SENSIPAR,

B - 11

**

CINACALCET HYDROCHLORIDE

AMNEAL PHARM
* AMNEAL PHARMACEUTICAL
ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUCONAZOLE, FLUCONAZOLE
FOLIC ACID, FOLIC ACID
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

AMNEAL PHARMS
* AMNEAL PHARMACEUTICALS
ALBUTEROL SULFATE, ALBUTEROL SULFATE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
FELBAMATE, FELBAMATE
IBUPROFEN, IBUPROFEN (OTC)
INDOMETHACIN, INDOMETHACIN
LEVETIRACETAM, LEVETIRACETAM
LORAZEPAM, LORAZEPAM
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
NITROFURANTOIN, NITROFURANTOIN
NIZATIDINE, NIZATIDINE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN
HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SPIRONOLACTONE, SPIRONOLACTONE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
* AMNEAL PHARMACEUTICALS LLC
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
AMNEAL PHARMS NY
* AMNEAL PHARMACEUTICALS NY LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ALPRAZOLAM, ALPRAZOLAM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
GABAPENTIN, GABAPENTIN
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NAPROXEN, NAPROXEN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* AMNEAL PHARMACEUTICALS NY LLC

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
REPREXAIN, HYDROCODONE BITARTRATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

AMPHASTAR PHARM
* AMPHASTAR PHARMACEUTICAL INC
AMPHADASE, HYALURONIDASE

ENOXAPARIN SODIUM (PRESERVATIVE FREE),

ENOXAPARIN SODIUM

AMPHASTAR PHARMS INC

* AMPHASTAR PHARMACEUTICALS INC
CORTROSYN, COSYNTROPIN
AMPOLGEN
* AMPOLGEN PHARMACEUTICALS LLC
SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE
AMYLIN
* AMYLIN PHARMACEUTICALS INC
BYETTA, EXENATIDE SYNTHETIC

SYMLIN, PRAMLINTIDE ACETATE

ANBEX
* ANBEX INC
IOSAT, POTASSIUM IODIDE

(OTC)

ANCHEN PHARMS
* ANCHEN PHARMACEUTICALS INC
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* ANCHEN PHARMACEUTICALS TAIWAN INC

DIVALPROEX SODIUM, DIVALPROEX SODIUM
* ANCHEN PHARMACEUTICALS, INC
ALPRAZOLAM, ALPRAZOLAM

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

ANDRX LABS LLC

* ANDRX LABS LLC
ALTOPREV, LOVASTATIN

FORTAMET, METFORMIN HYDROCHLORIDE

ANESTA AG
* ANESTA AG
AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE
ANGELINI LLC
* ANGELINI LABOPHARM LLC
OLEPTRO, TRAZODONE HYDROCHLORIDE
ANI PHARMS
* ANI PHARMACEUTICALS INC
CORTENEMA, HYDROCORTISONE
LACTULOSE, LACTULOSE
LUVOX, FLUVOXAMINE MALEATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

REGLAN, METOCLOPRAMIDE HYDROCHLORIDE

ANTARES PHARMA INC

* ANTARES PHARMA INC
ANTUROL, OXYBUTYNIN
ANTIBIOTICOS BRASIL
* ANTIBIOTICOS DO BRASIL LTDA
CEFOXITIN, CEFOXITIN
APOPHARMA INC
* APOPHARMA INC
FERRIPROX, DEFERIPRONE

B - 12

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

APOTEX
* APOTEX CORP
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

* APOTEX INC
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
BUDESONIDE, BUDESONIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CAPTOPRIL, CAPTOPRIL
CARBIDOPA AND LEVODOPA, CARBIDOPA
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CIMETIDINE, CIMETIDINE
CIMETIDINE, CIMETIDINE (OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
CYCLOSPORINE, CYCLOSPORINE
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
DILT-CD, DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
EPLERENONE, EPLERENONE
ETODOLAC, ETODOLAC
FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE, FAMOTIDINE
FLUCONAZOLE, FLUCONAZOLE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
GEMFIBROZIL, GEMFIBROZIL
GLIPIZIDE, GLIPIZIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
KETOCONAZOLE, KETOCONAZOLE
LAMIVUDINE, LAMIVUDINE
LATANOPROST, LATANOPROST
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NIZATIDINE, NIZATIDINE
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PENTOXIFYLLINE, PENTOXIFYLLINE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

B - 13

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

APOTEX CORP
* APOTEX CORP
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AZITHROMYCIN, AZITHROMYCIN
CICLOPIROX, CICLOPIROX
CLARITHROMYCIN, CLARITHROMYCIN
GATIFLOXACIN, GATIFLOXACIN
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NARATRIPTAN, NARATRIPTAN

APOTEX INC
* APOTEX INC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALPRAZOLAM, ALPRAZOLAM
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
CALCITONIN-SALMON, CALCITONIN SALMON
CARBAMAZEPINE, CARBAMAZEPINE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CEFPROZIL, CEFPROZIL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CEVIMELINE, CEVIMELINE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LOVASTATIN, LOVASTATIN
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
NABUMETONE, NABUMETONE
OFLOXACIN, OFLOXACIN
OLANZAPINE, OLANZAPINE
OXCARBAZEPINE, OXCARBAZEPINE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
TIMOLOL MALEATE, TIMOLOL MALEATE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* APOTEX INC ETOBICOKE SITE

ACYCLOVIR, ACYCLOVIR
ALLOPURINOL, ALLOPURINOL
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARBAMAZEPINE, CARBAMAZEPINE
CARVEDILOL, CARVEDILOL
CILOSTAZOL, CILOSTAZOL
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DILTZAC, DILTIAZEM HYDROCHLORIDE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ETODOLAC, ETODOLAC
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)

LEFLUNOMIDE, LEFLUNOMIDE

B - 14

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A

**

* APOTEX INC ETOBICOKE SITE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LITHIUM CARBONATE, LITHIUM CARBONATE
LORATADINE, LORATADINE (OTC)
MELOXICAM, MELOXICAM
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
OXAPROZIN, OXAPROZIN
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TORSEMIDE, TORSEMIDE

ZONISAMIDE, ZONISAMIDE

* APOTEX INC RICHMOND HILL

ALBUTEROL SULFATE, ALBUTEROL SULFATE
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUNISOLIDE, FLUNISOLIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LORATADINE, LORATADINE (OTC)
MEGESTROL ACETATE, MEGESTROL ACETATE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
PREDNISOLONE, PREDNISOLONE

RISPERIDONE, RISPERIDONE

* APOTEX INC.
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
APOTHECON
* APOTHECON INC DIV BRISTOL MYERS SQUIBB
CAPOZIDE 25/15, CAPTOPRIL
CAPOZIDE 25/25, CAPTOPRIL
CAPOZIDE 50/15, CAPTOPRIL
CAPOZIDE 50/25, CAPTOPRIL
KENALOG, TRIAMCINOLONE ACETONIDE
KENALOG-10, TRIAMCINOLONE ACETONIDE
KENALOG-40, TRIAMCINOLONE ACETONIDE
KLOTRIX, POTASSIUM CHLORIDE
OPHTHAINE, PROPARACAINE HYDROCHLORIDE
STADOL PRESERVATIVE FREE, BUTORPHANOL TARTRATE
STADOL, BUTORPHANOL TARTRATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

APP PHARMS
* APP PHARMACEUTICALS
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

PROTAMINE SULFATE, PROTAMINE SULFATE

* APP PHARMACEUTICALS LLC

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
ADENOSINE, ADENOSINE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ASTRAMORPH PF, MORPHINE SULFATE
AZITHROMYCIN, AZITHROMYCIN
AZTREONAM, AZTREONAM
BACITRACIN, BACITRACIN
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

B - 15

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* APP PHARMACEUTICALS LLC

CAFFEINE CITRATE, CAFFEINE CITRATE
CALCITRIOL, CALCITRIOL
CARBOPLATIN, CARBOPLATIN
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFOTAXIME, CEFOTAXIME SODIUM
CEFOXITIN, CEFOXITIN SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM
CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
CISPLATIN, CISPLATIN
CLADRIBINE, CLADRIBINE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
CYTARABINE, CYTARABINE
DACARBAZINE, DACARBAZINE
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DIMENHYDRINATE, DIMENHYDRINATE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPRIVAN, PROPOFOL
DIPYRIDAMOLE, DIPYRIDAMOLE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
DOXY 100, DOXYCYCLINE HYCLATE
DOXY 200, DOXYCYCLINE HYCLATE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
ETOPOSIDE, ETOPOSIDE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FLOXURIDINE, FLOXURIDINE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUMAZENIL, FLUMAZENIL
FLUOROURACIL, FLUOROURACIL
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
FOLIC ACID, FOLIC ACID
FUROSEMIDE, FUROSEMIDE
GANCICLOVIR, GANCICLOVIR SODIUM
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE
HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
IFOSFAMIDE, IFOSFAMIDE
INDOMETHACIN, INDOMETHACIN
IOPAMIDOL-250, IOPAMIDOL
IOPAMIDOL-300, IOPAMIDOL
IOPAMIDOL-370, IOPAMIDOL
KANAMYCIN SULFATE, KANAMYCIN SULFATE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
MANNITOL 25%, MANNITOL

MESNA, MESNA

B - 16

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A

**

* APP PHARMACEUTICALS LLC

METARAMINOL BITARTRATE, METARAMINOL BITARTRATE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NAROPIN, ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
NEBUPENT, PENTAMIDINE ISETHIONATE
NESACAINE, CHLOROPROCAINE HYDROCHLORIDE
NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
OXYTOCIN, OXYTOCIN
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
PENTAM, PENTAMIDINE ISETHIONATE
POLOCAINE, MEPIVACAINE HYDROCHLORIDE
POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PROGESTERONE, PROGESTERONE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
SENSORCAINE, BUPIVACAINE HYDROCHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE
TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VALPROATE SODIUM, VALPROATE SODIUM
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VIBISONE, CYANOCOBALAMIN
VINBLASTINE SULFATE, VINBLASTINE SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

* APP PHARMACEUTICALS, LLC--A CO. OF THE FRESENIUS KABI GROUP

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
CEFOTETAN, CEFOTETAN DISODIUM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

APTALIS PHARMA US
* APTALIS PHARMA US INC
BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE
BENTYL, DICYCLOMINE HYDROCHLORIDE
CARAFATE, SUCRALFATE
PYLERA, BISMUTH SUBCITRATE POTASSIUM
URSO 250, URSODIOL

URSO FORTE, URSODIOL

B - 17

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* APTALIS PHARMA US INC

ZENPEP, LIPASE
AQUA PHARMS
* AQUA PHARMACEUTICALS LLC
SOLAGE, MEQUINOL

XOLEGEL, KETOCONAZOLE

AR HOLDING CO INC
* AR HOLDING CO INC
COLCRYS, COLCHICINE
FIBRICOR, FENOFIBRIC ACID

QUALAQUIN, QUININE SULFATE

ARBOR PHARMS INC

* ARBOR PHARMACEUTICALS INC
BIDIL, HYDRALAZINE HYDROCHLORIDE
E.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATE
E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE

E.E.S., ERYTHROMYCIN ETHYLSUCCINATE

ERYPED, ERYTHROMYCIN ETHYLSUCCINATE

ERY-TAB, ERYTHROMYCIN

ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

ERYTHROMYCIN, ERYTHROMYCIN

PCE, ERYTHROMYCIN

PEDIAMYCIN 400, ERYTHROMYCIN ETHYLSUCCINATE

PEDIAMYCIN, ERYTHROMYCIN ETHYLSUCCINATE

ARCHIMEDES
* ARCHIMEDES DEVELOPMENT LTD
LAZANDA, FENTANYL CITRATE
AREVA PHARMS
* AREVA PHARMACEUTICALS INC
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
ARMSTRONG PHARMS
* ARMSTRONG PHARMACEUTICALS INC
EPINEPHRINE, EPINEPHRINE (OTC)
ASCEND
* ASCEND THERAPEUTICS INC
ESTROGEL, ESTRADIOL
ASPEN GLOBAL
* ASPEN GLOBAL INC
MYLERAN, BUSULFAN
ASTELLAS
* ASTELLAS PHARMA US INC
ADENOCARD, ADENOSINE
ADENOSCAN, ADENOSINE
AMBISOME, AMPHOTERICIN B
LEXISCAN, REGADENOSON
MYCAMINE, MICAFUNGIN SODIUM
PROGRAF, TACROLIMUS
PROTOPIC, TACROLIMUS
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER,
VESICARE, SOLIFENACIN SUCCINATE
ASTRAZENECA
* ASTRAZENECA LP
ENTOCORT EC, BUDESONIDE
NEXIUM IV, ESOMEPRAZOLE SODIUM
NEXIUM, ESOMEPRAZOLE MAGNESIUM
PRILOSEC OTC, OMEPRAZOLE MAGNESIUM
PRILOSEC, OMEPRAZOLE
PRILOSEC, OMEPRAZOLE MAGNESIUM

PULMICORT FLEXHALER, BUDESONIDE

(OTC)

CONIVAPTAN HYDROCHLORIDE

B - 18

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** A

**

* ASTRAZENECA LP
PULMICORT RESPULES, BUDESONIDE
RHINOCORT, BUDESONIDE
SEROQUEL, QUETIAPINE FUMARATE
SYMBICORT, BUDESONIDE
TENORMIN, ATENOLOL

TOPROL-XL, METOPROLOL SUCCINATE

* ASTRAZENECA PHARMACEUTICALS LP
ATACAND HCT, CANDESARTAN CILEXETIL
ATACAND, CANDESARTAN CILEXETIL
FASLODEX, FULVESTRANT
PLENDIL, FELODIPINE
PULMICORT, BUDESONIDE
SEROQUEL XR, QUETIAPINE FUMARATE
TENORETIC 100, ATENOLOL
TENORETIC 50, ATENOLOL
ZOMIG, ZOLMITRIPTAN

ZOMIG-ZMT, ZOLMITRIPTAN

* ASTRAZENECA UK LTD
ACCOLATE, ZAFIRLUKAST
ARIMIDEX, ANASTROZOLE
CASODEX, BICALUTAMIDE
MERREM, MEROPENEM
ZESTORETIC, HYDROCHLOROTHIAZIDE
ZESTRIL, LISINOPRIL

ZOLADEX, GOSERELIN ACETATE

ASTRAZENECA LP
* ASTRAZENECA LP
BRILINTA, TICAGRELOR

VIMOVO, ESOMEPRAZOLE MAGNESIUM

ATON
* ATON PHARMA INC
CUPRIMINE, PENICILLAMINE
DEMSER, METYROSINE
EDECRIN, ETHACRYNATE SODIUM
EDECRIN, ETHACRYNIC ACID
LACRISERT, HYDROXYPROPYL CELLULOSE
LODOSYN, CARBIDOPA
SYPRINE, TRIENTINE HYDROCHLORIDE
TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE
TIMOPTIC, TIMOLOL MALEATE

TIMOPTIC-XE, TIMOLOL MALEATE

AUROBINDO
* AUROBINDO PHARMA LTD
AMOXICILLIN, AMOXICILLIN
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE

ZIDOVUDINE, ZIDOVUDINE

AUROBINDO PHARM
* AUROBINDO PHARMA USA INC
ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
LEVETIRACETAM, LEVETIRACETAM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

B - 19

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

AUROBINDO PHARMA
* AUROBINDO PHARMA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
* AUROBINDO PHARMA LTD
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN, AMOXICILLIN
AMPICILLIN SODIUM, AMPICILLIN SODIUM
ATENOLOL, ATENOLOL
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
CARISOPRODOL, CARISOPRODOL
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFDINIR, CEFDINIR
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CEFTAZIDIME, CEFTAZIDIME
CEFTRIAXONE, CEFTRIAXONE SODIUM
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DIDANOSINE, DIDANOSINE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GLYBURIDE, GLYBURIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MELOXICAM, MELOXICAM
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
RIBAVARIN, RIBAVIRIN
RIBAVIRIN, RIBAVIRIN
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
STAVUDINE, STAVUDINE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TORSEMIDE, TORSEMIDE
TRANDOLAPRIL, TRANDOLAPRIL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZALEPLON, ZALEPLON

B - 20

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

* AUROBINDO PHARMA LTD

ZOLPIDEM TARTRATE,

**

ZOLPIDEM TARTRATE

AUROBINDO PHARMA LTD

* AUROBINDO PHARMA LIMITED
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
LEVOFLOXACIN, LEVOFLOXACIN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

* AUROBINDO PHARMA LTD

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
FAMCICLOVIR, FAMCICLOVIR
GABAPENTIN, GABAPENTIN
LAMIVUDINE, LAMIVUDINE
NAPROXEN SODIUM, NAPROXEN SODIUM
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

RAMIPRIL, RAMIPRIL

* AUROBINDO PHARMA LTD INC

CEFPROZIL, CEFPROZIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
MIRTAZAPINE, MIRTAZAPINE

ZIDOVUDINE, ZIDOVUDINE

AUROBINDO PHARMA USA

* AUROBINDO PHARMA USA INC
ALPRAZOLAM, ALPRAZOLAM

NAPROXEN, NAPROXEN

AUROSAL PHARMS
* AUROSAL PHARMACEUTICALS LLC
AMIODARONE HYDROCHLORIDE,

AMIODARONE HYDROCHLORIDE

AUSTARPHARMA LLC
* AUSTARPHARMA LLC
ALENDRONATE SODIUM, ALENDRONATE SODIUM
METHOCARBAMOL, METHOCARBAMOL

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

AUXILIUM PHARMS
* AUXILIUM PHARMACEUTICALS
TESTIM, TESTOSTERONE
AVACOR PRODS
* AVACOR PRODUCTS LLC
MINOXIDIL EXTRA STRENGTH (FOR MEN),

MINOXIDIL

(OTC)

AVANIR PHARMS
* AVANIR PHARMACEUTICALS INC
NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE
AVANTHI INC
* AVANTHI INC
CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC)
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

AVEMA PHARMA
* AVEMA PHARMA SOLUTIONS
IBUPROFEN, IBUPROFEN

(OTC)

AVENT
* AVENT INC
PYTEST KIT, UREA, C-14

PYTEST, UREA, C-14

B - 21

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 22

PRODUCT NAME SORTED BY APPLICANT

**

**

AVEVA
* AVEVA DRUG DELIVERY SYSTEMS INC
CLONIDINE, CLONIDINE

NICOTINE, NICOTINE (OTC)

AXCAN
* AXCAN PHARMA US INC
CANASA, MESALAMINE
AZTIQ PHARMA
* AZTIQ PHARMA INC
TODAY, NONOXYNOL-9

(OTC)

AZUR PHARMA
* AZUR PHARMA INTERNATIONAL LTD
AVC, SULFANILAMIDE

GASTROCROM, CROMOLYN SODIUM

AZUR PHARMA II
* AZUR PHARMA INTERNATIONAL II LTD
ELESTRIN, ESTRADIOL

PRIALT, ZICONOTIDE ACETATE

AZUR PHARMA INTL

* AZUR PHARMA INTERNATIONAL III LTD
FAZACLO ODT, CLOZAPINE
B BRAUN
* B BRAUN MEDICAL INC
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
ALCOHOL 10% AND DEXTROSE 5%, ALCOHOL
ALCOHOL 5% AND DEXTROSE 5%, ALCOHOL
BALANCED SALT, CALCIUM CHLORIDE
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE
CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM
CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 23

PRODUCT NAME SORTED BY APPLICANT

**

**

* B BRAUN MEDICAL INC

DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE
FREAMINE HBC 6.9%, AMINO ACIDS
FREAMINE III 10%, AMINO ACIDS
FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5%, AMINO ACIDS
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPATAMINE 8%, AMINO ACIDS
ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE E IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
HYDROCHLORIDE
MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER, MANNITOL
MANNITOL 10%, MANNITOL
MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%, MANNITOL
MANNITOL 15%, MANNITOL
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 20%, MANNITOL
MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%, MANNITOL
MANNITOL 5%, MANNITOL
METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
NEPHRAMINE 5.4%, AMINO ACIDS
NUTRILIPID 10%, SOYBEAN OIL
NUTRILIPID 20%, SOYBEAN OIL
PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 24

PRODUCT NAME SORTED BY APPLICANT

**

**

* B BRAUN MEDICAL INC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 25

PRODUCT NAME SORTED BY APPLICANT

**

**

* B BRAUN MEDICAL INC

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PROCALAMINE, AMINO ACIDS
RESECTISOL IN PLASTIC CONTAINER, MANNITOL
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
TROPHAMINE 10%, AMINO ACIDS
TROPHAMINE, AMINO ACIDS
BANNER PHARMACAPS
* BANNER PHARMACAPS INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
BENZONATATE, BENZONATATE
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ETHOSUXIMIDE, ETHOSUXIMIDE
IBUPROFEN AND DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
MIDOL LIQUID GELS, IBUPROFEN (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NIMODIPINE, NIMODIPINE
STAVZOR, VALPROIC ACID
VALPROIC ACID, VALPROIC ACID
VITAMIN D, ERGOCALCIFEROL

ZONISAMIDE, ZONISAMIDE

BARR
* BARR LABORATORIES INC
ALPRAZOLAM, ALPRAZOLAM
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

ARANELLE, ETHINYL ESTRADIOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 26

PRODUCT NAME SORTED BY APPLICANT

**

**

* BARR LABORATORIES INC

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN
BALZIVA-28, ETHINYL ESTRADIOL
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CAMILA, NORETHINDRONE
CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORZOXAZONE, CHLORZOXAZONE
CLARAVIS, ISOTRETINOIN
CLONAZEPAM, CLONAZEPAM
CLONIDINE, CLONIDINE
DANAZOL, DANAZOL
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
ASPARTATE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DIAZEPAM, DIAZEPAM
DIDANOSINE, DIDANOSINE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
DUTASTERIDE, DUTASTERIDE
ERRIN, NORETHINDRONE
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, ERYTHROMYCIN ETHYLSUCCINATE
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
ESTRADIOL AND NORGESTIMATE, ESTRADIOL
ESTRADIOL, ESTRADIOL
ESTROPIPATE, ESTROPIPATE
ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE
FENTANYL CITRATE, FENTANYL CITRATE
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
HYDROXYUREA, HYDROXYUREA
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
ISONIAZID, ISONIAZID
JUNEL 1.5/30, ETHINYL ESTRADIOL
JUNEL 1/20, ETHINYL ESTRADIOL
JUNEL FE 1.5/30, ETHINYL ESTRADIOL
JUNEL FE 1/20, ETHINYL ESTRADIOL
KARIVA, DESOGESTREL
KELNOR, ETHINYL ESTRADIOL
LEFLUNOMIDE, LEFLUNOMIDE
LESSINA-28, ETHINYL ESTRADIOL
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEGESTROL ACETATE, MEGESTROL ACETATE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORTREL 0.5/35-28, ETHINYL ESTRADIOL
NORTREL 1/35-21, ETHINYL ESTRADIOL
NORTREL 1/35-28, ETHINYL ESTRADIOL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* BARR LABORATORIES INC

NORTREL 7/7/7, ETHINYL ESTRADIOL
ONDANSETRON, ONDANSETRON
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PORTIA-28, ETHINYL ESTRADIOL
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
SPRINTEC, ETHINYL ESTRADIOL
TEMOZOLOMIDE, TEMOZOLOMIDE
TRETINOIN, TRETINOIN
TREXALL, METHOTREXATE SODIUM
TRI LO SPRINTEC, ETHINYL ESTRADIOL
TRI-LEGEST 21, ETHINYL ESTRADIOL
TRI-LEGEST FE, ETHINYL ESTRADIOL
TRI-SPRINTEC, ETHINYL ESTRADIOL
WARFARIN SODIUM, WARFARIN SODIUM

ZONISAMIDE, ZONISAMIDE

* BARR PHARMACEUTICALS
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
BARR LABS INC
* BARR LABORATORIES INC
NIMODIPINE, NIMODIPINE

OXYCODONE HYDROCHLORIDE AND IBUPROFEN,

IBUPROFEN

BAUSCH AND LOMB

* BAUSCH AND LOMB INC
ALAWAY, KETOTIFEN FUMARATE (OTC)
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALREX, LOTEPREDNOL ETABONATE
BESIVANCE, BESIFLOXACIN HYDROCHLORIDE
CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LATANOPROST, LATANOPROST
LOTEMAX, LOTEPREDNOL ETABONATE
MIOCHOL-E, ACETYLCHOLINE CHLORIDE
OFLOXACIN, OFLOXACIN
OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
RETISERT, FLUOCINOLONE ACETONIDE
TIMOLOL MALEATE, TIMOLOL MALEATE
VITRASERT, GANCICLOVIR
ZIRGAN, GANCICLOVIR

ZYLET, LOTEPREDNOL ETABONATE

* BAUSCH AND LOMB PHARMACEUTICALS INC

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE, ACETIC ACID, GLACIAL
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CROLOM, CROMOLYN SODIUM
CROMOLYN SODIUM, CROMOLYN SODIUM
CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DEXASPORIN, DEXAMETHASONE
ERYTHROMYCIN, ERYTHROMYCIN
FLUNISOLIDE, FLUNISOLIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

B - 27

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 28

PRODUCT NAME SORTED BY APPLICANT

**

**

* BAUSCH AND LOMB PHARMACEUTICALS INC

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC
OFLOXACIN, OFLOXACIN
OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
OTICAIR, HYDROCORTISONE
PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TIMOLOL MALEATE, TIMOLOL MALEATE
TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE
TOBRAMYCIN, TOBRAMYCIN
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TROPICAMIDE, TROPICAMIDE

BAXTER HLTHCARE
* BAXTER HEALTHCARE CORP
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
ADENOSINE, ADENOSINE
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE
ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM
BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM
BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS
CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE
CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC
CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC
CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC
CONTAINER, AMINO ACIDS
CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC
CONTAINER, AMINO ACIDS
CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC
CONTAINER, AMINO ACIDS
CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,
AMINO ACIDS
CYTOXAN, CYCLOPHOSPHAMIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 29

PRODUCT NAME SORTED BY APPLICANT

**

**

* BAXTER HEALTHCARE CORP

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER,
DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER,
DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER,
DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER,
DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER,
DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER,
DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC
CONTAINER, DEXTROSE
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
EXTRANEAL, ICODEXTRIN
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 30

PRODUCT NAME SORTED BY APPLICANT

**

**

* BAXTER HEALTHCARE CORP

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPATASOL 8%, AMINO ACIDS
IFEX, IFOSFAMIDE
ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER, GENTAMICIN SULFATE
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
HYDROCHLORIDE
MESNEX, MESNA
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM
NEXTERONE, AMIODARONE HYDROCHLORIDE
NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN
ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER, ONDANSETRON
HYDROCHLORIDE
OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 10% IN WATER, MANNITOL
OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 15% IN WATER, MANNITOL
OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 20% IN WATER, MANNITOL
OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 5% IN WATER, MANNITOL
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 56 IN PLASTIC CONTAINER, MAGNESIUM ACETATE TETRAHYDRATE
PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLASMA-LYTE R IN PLASTIC CONTAINER, CALCIUM CHLORIDE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM
CHLORIDE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
CALCIUM CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 31

PRODUCT NAME SORTED BY APPLICANT

**

**

* BAXTER HEALTHCARE CORP

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS
RENAMIN W/O ELECTROLYTES, AMINO ACIDS
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
SEVOFLURANE, SEVOFLURANE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
STERILE WATER, STERILE WATER FOR IRRIGATION
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE
TIS-U-SOL, MAGNESIUM SULFATE
TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 10% W/O ELECTROLYTES, AMINO ACIDS
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 3.5% W/ ELECTROLYTES, AMINO ACIDS
TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% W/ ELECTROLYTES, AMINO ACIDS
TRAVASOL 5.5% W/O ELECTROLYTES, AMINO ACIDS
TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% W/ ELECTROLYTES, AMINO ACIDS
TRAVASOL 8.5% W/O ELECTROLYTES, AMINO ACIDS
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE
* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM
ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
BUMETANIDE, BUMETANIDE
CEFOXITIN, CEFOXITIN SODIUM
CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DIGOXIN, DIGOXIN
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
DOPRAM, DOXAPRAM HYDROCHLORIDE

DURAMORPH PF, MORPHINE SULFATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** B

**

* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
FLUMAZENIL, FLUMAZENIL
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HEPARIN SODIUM, HEPARIN SODIUM
INFUMORPH, MORPHINE SULFATE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
MITOMYCIN, MITOMYCIN
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
ROBINUL, GLYCOPYRROLATE
SUFENTANIL CITRATE, SUFENTANIL CITRATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

* BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

BAXTER HLTHCARE CORP

* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE
* BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE
ATIVAN, LORAZEPAM
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC, ESMOLOL HYDROCHLORIDE
ETHRANE, ENFLURANE
FORANE, ISOFLURANE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
OXYTOCIN, OXYTOCIN
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE
REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
ROBAXIN, METHOCARBAMOL

SUPRANE, DESFLURANE

BAYER
* BAYER HEALTHCARE LLC
ALEVE, NAPROXEN SODIUM (OTC)
ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)

FEMSTAT 3, BUTOCONAZOLE NITRATE (OTC)

BAYER HLTHCARE
* BAYER HEALTHCARE CONSUMER CARE
RID MOUSSE, PIPERONYL BUTOXIDE (OTC)
* BAYER HEALTHCARE PHARMACEUTICALS INC
ADALAT CC, NIFEDIPINE
ANGELIQ, DROSPIRENONE
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE
AVELOX, MOXIFLOXACIN HYDROCHLORIDE
BETAPACE AF, SOTALOL HYDROCHLORIDE
BETAPACE, SOTALOL HYDROCHLORIDE
BEYAZ, DROSPIRENONE
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPRO XR, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN

CIPRO, CIPROFLOXACIN HYDROCHLORIDE

B - 32

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* BAYER HEALTHCARE PHARMACEUTICALS INC

CLIMARA PRO, ESTRADIOL
CLIMARA, ESTRADIOL
DTIC-DOME, DACARBAZINE
EOVIST, GADOXETATE DISODIUM
GADAVIST, GADOBUTROL
LEVITRA, VARDENAFIL HYDROCHLORIDE
MAGNEVIST, GADOPENTETATE DIMEGLUMINE
MENOSTAR, ESTRADIOL
MIRENA, LEVONORGESTREL
MYCELEX, CLOTRIMAZOLE
NATAZIA, ESTRADIOL VALERATE
NEXAVAR, SORAFENIB TOSYLATE
PRECOSE, ACARBOSE
REFLUDAN, LEPIRUDIN RECOMBINANT
SAFYRAL, DROSPIRENONE
STAXYN, VARDENAFIL HYDROCHLORIDE
TRASYLOL, APROTININ
ULTRAVIST (PHARMACY BULK), IOPROMIDE
ULTRAVIST 150, IOPROMIDE
ULTRAVIST 240, IOPROMIDE
ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE
ULTRAVIST 300, IOPROMIDE
ULTRAVIST 370, IOPROMIDE
YASMIN, DROSPIRENONE

YAZ, DROSPIRENONE

BAYER PHARMA AG
* BAYER PHARMA AG
BILTRICIDE, PRAZIQUANTEL
BAYER PHARMS
* BAYER PHARMACEUTICALS CORP
MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE
MYCELEX-7, CLOTRIMAZOLE (OTC)

(OTC)

BECTON DICKINSON
* BECTON DICKINSON AND CO
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
E-Z SCRUB 201, POVIDONE-IODINE (OTC)

E-Z SCRUB 241, POVIDONE-IODINE (OTC)

(OTC)

BEDFORD
* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM
ACETYLCYSTEINE, ACETYLCYSTEINE
ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
ADENOSINE, ADENOSINE
ALPROSTADIL, ALPROSTADIL
AMIKACIN SULFATE, AMIKACIN SULFATE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMRINONE LACTATE, INAMRINONE LACTATE
ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE
ATRACURIUM BESYLATE, ATRACURIUM BESYLATE
AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM
AZTREONAM, AZTREONAM
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BUMETANIDE, BUMETANIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CARBOPLATIN, CARBOPLATIN
CEFTRIAXONE, CEFTRIAXONE SODIUM
CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE
CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE

CISPLATIN, CISPLATIN

B - 33

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

CLADRIBINE, CLADRIBINE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CYCLOSPORINE, CYCLOSPORINE
CYTARABINE, CYTARABINE
DACARBAZINE, DACARBAZINE
DACTINOMYCIN, DACTINOMYCIN
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
DOXYCYCLINE, DOXYCYCLINE HYCLATE
ENALAPRILAT, ENALAPRILAT
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
ETOMIDATE, ETOMIDATE
ETOPOSIDE, ETOPOSIDE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FLOXURIDINE, FLOXURIDINE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE
INDOMETHACIN SODIUM, INDOMETHACIN SODIUM
KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEVOCARNITINE, LEVOCARNITINE
LORAZEPAM, LORAZEPAM
MESNA, MESNA
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
MITOMYCIN, MITOMYCIN
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PACLITAXEL, PACLITAXEL
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RIFAMPIN, RIFAMPIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
THIOTEPA, THIOTEPA
VALPROATE SODIUM, VALPROATE SODIUM
VECURONIUM BROMIDE, VECURONIUM BROMIDE

VINBLASTINE SULFATE, VINBLASTINE SULFATE

B - 34

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 35

PRODUCT NAME SORTED BY APPLICANT

**

**

* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

VINORELBINE TARTRATE, VINORELBINE TARTRATE
BEDFORD LABS
* BEDFORD LABORATORIES
ALLOPURINOL SODIUM, ALLOPURINOL SODIUM
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
CARBOPLATIN, CARBOPLATIN
DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUMAZENIL, FLUMAZENIL
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
IFOSFAMIDE, IFOSFAMIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LORAZEPAM PRESERVATIVE FREE, LORAZEPAM
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
PENTOSTATIN, PENTOSTATIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TORSEMIDE, TORSEMIDE

BEIJING DOUBLE CRANE

* BEIJING DOUBLE CRANE PHARMACEUTICAL CO LTD
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

MELOXICAM, MELOXICAM

BELCHER PHARMS
* BELCHER PHARMACEUTICALS LLC
CEPHALEXIN, CEPHALEXIN
BEN VENUE
* BEN VENUE LABORATORIES INC
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

BEXIMCO USA
* BEXIMCO PHARMACEUTICALS USA INC
CARVEDILOL, CARVEDILOL
BIO NUCLEONICS
* BIO NUCLEONICS INC
STRONTIUM CHLORIDE SR-89,

STRONTIUM CHLORIDE SR-89

BIOALLIANCE PHARMA
* BIOALLIANCE PHARMA
ORAVIG, MICONAZOLE
BIOKEY
* BIOKEY INC
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

BIOMARIN PHARM
* BIOMARIN PHARMACEUTICAL INC
KUVAN, SAPROPTERIN DIHYDROCHLORIDE
BIONICHE PHARMA
* BIONICHE PHARMA USA LLC
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

COSYNTROPIN, COSYNTROPIN

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* BIONICHE PHARMA USA LLC

DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
ENLON, EDROPHONIUM CHLORIDE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
FLUOROURACIL, FLUOROURACIL
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE
MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
RIMSO-50, DIMETHYL SULFOXIDE

SOTRADECOL, SODIUM TETRADECYL SULFATE

BIONICHE PHARMA USA

* BIONICHE PHARMA USA LLC
CARBOPLATIN, CARBOPLATIN
DURACLON, CLONIDINE HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FOMEPIZOLE, FOMEPIZOLE
IBUTILIDE FUMARATE, IBUTILIDE FUMARATE
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

BIOVAIL TECHNOLOGIES
* BIOVAIL TECHNOLOGIES LTD
MEPHYTON, PHYTONADIONE
BLAIREX
* BLAIREX LABORATORIES INC
BRONCHO SALINE, SODIUM CHLORIDE
BLU CARIBE
* BLU CARIBE INC
GEMFIBROZIL,
SIMVASTATIN,

(OTC)

GEMFIBROZIL

SIMVASTATIN

BOCA PHARMA
* BOCA PHARMACAL INC
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN
ALPRAZOLAM, ALPRAZOLAM
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
LEVETIRACETAM, LEVETIRACETAM

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE

BOEHRINGER INGELHEIM
* BOEHRINGER INGELHEIM
CATAPRES, CLONIDINE HYDROCHLORIDE
CATAPRES-TTS-1, CLONIDINE
CATAPRES-TTS-2, CLONIDINE
CATAPRES-TTS-3, CLONIDINE
MICARDIS HCT, HYDROCHLOROTHIAZIDE
MICARDIS, TELMISARTAN
MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE
ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC)

ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC)

* BOEHRINGER INGELHEIM PHARMACEUTICALS INC

AGGRENOX, ASPIRIN
APTIVUS, TIPRANAVIR
ATROVENT HFA, IPRATROPIUM BROMIDE
ATROVENT, IPRATROPIUM BROMIDE
COMBIVENT RESPIMAT, ALBUTEROL SULFATE

COMBIVENT, ALBUTEROL SULFATE

B - 36

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* BOEHRINGER INGELHEIM PHARMACEUTICALS INC

FLOMAX, TAMSULOSIN HYDROCHLORIDE
MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE
MOBIC, MELOXICAM
PERSANTINE, DIPYRIDAMOLE
PRADAXA, DABIGATRAN ETEXILATE MESYLATE
SPIRIVA, TIOTROPIUM BROMIDE MONOHYDRATE
TRADJENTA, LINAGLIPTIN
TWYNSTA, AMLODIPINE BESYLATE
VIRAMUNE XR, NEVIRAPINE

VIRAMUNE, NEVIRAPINE

BRACCO
* BRACCO DIAGNOSTICS INC
CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82
CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT
CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE
CHROMITOPE SODIUM, SODIUM CHROMATE CR-51
CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE
CYSTOGRAFIN, DIATRIZOATE MEGLUMINE
GASTROGRAFIN, DIATRIZOATE MEGLUMINE
ISOVUE-200, IOPAMIDOL
ISOVUE-250, IOPAMIDOL
ISOVUE-300, IOPAMIDOL
ISOVUE-370, IOPAMIDOL
ISOVUE-M 200, IOPAMIDOL
ISOVUE-M 300, IOPAMIDOL
KINEVAC, SINCALIDE
MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT
MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE
MULTIHANCE, GADOBENATE DIMEGLUMINE
PROHANCE MULTIPACK, GADOTERIDOL
PROHANCE, GADOTERIDOL
RENOGRAFIN-76, DIATRIZOATE MEGLUMINE

SINOGRAFIN, DIATRIZOATE MEGLUMINE

BRAINTREE
* BRAINTREE LABORATORIES INC
AXID, NIZATIDINE
GOLYTELY, POLYETHYLENE GLYCOL 3350
HALFLYTELY, BISACODYL
NULYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350

BRAINTREE LABS
* BRAINTREE LABORATORIES INC
SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE ANHYDROUS
BRECKENRIDGE PHARM
* BRECKENRIDGE PHARMACEUTICAL INC
CILOSTAZOL, CILOSTAZOL
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
LEVETIRACETAM, LEVETIRACETAM
MELOXICAM, MELOXICAM
METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE
OXCARBAZEPINE, OXCARBAZEPINE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

BRIGHTSTONE
* BRIGHTSTONE PHARMA INC
ISOSORBIDE MONONITRATE,

ISOSORBIDE MONONITRATE

BRISTOL
* BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
BICNU, CARMUSTINE

B - 37

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

BRISTOL MYERS SQUIBB

* BRISTOL MYERS SQUIBB
AZACTAM, AZTREONAM
BARACLUDE, ENTECAVIR
GLUCOVANCE, GLYBURIDE
KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE
LYSODREN, MITOTANE
MEGACE, MEGESTROL ACETATE

PRAVACHOL, PRAVASTATIN SODIUM

* BRISTOL MYERS SQUIBB CO

AZACTAM IN PLASTIC CONTAINER, AZTREONAM
CEENU, LOMUSTINE
DROXIA, HYDROXYUREA
GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE
HYDREA, HYDROXYUREA
IXEMPRA KIT, IXABEPILONE
ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE
REYATAZ, ATAZANAVIR SULFATE
SPRYCEL, DASATINIB
SUSTIVA, EFAVIRENZ

VIDEX EC, DIDANOSINE

* BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

ESTRACE, ESTRADIOL
ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE
GLUCOPHAGE, METFORMIN HYDROCHLORIDE
MONOPRIL, FOSINOPRIL SODIUM
VIDEX, DIDANOSINE
VUMON, TENIPOSIDE

ZERIT, STAVUDINE

* BRISTOL MYERS SQUIBB PHARMA CO

COUMADIN, WARFARIN SODIUM

SUSTIVA, EFAVIRENZ

BRYAN
* BRYAN CORP
SCLEROSOL, TALC

TALC, TALC

CADENCE PHARMS
* CADENCE PHARMACEUTICALS INC
OFIRMEV, ACETAMINOPHEN
CADISTA PHARMS
* CADISTA PHARMACEUTICALS INC
ALENDRONATE SODIUM, ALENDRONATE SODIUM
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
LAMOTRIGINE, LAMOTRIGINE

OXCARBAZEPINE, OXCARBAZEPINE

CANYON
* CANYON PHARMACEUTICALS INC
IPRIVASK, DESIRUDIN RECOMBINANT
CARACO
* CARACO PHARMACEUTICAL LABORATORIES LTD
ALLOPURINOL, ALLOPURINOL
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ATENOLOL, ATENOLOL
BACLOFEN, BACLOFEN
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLONAZEPAM, CLONAZEPAM

B - 38

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** C

**

* CARACO PHARMACEUTICAL LABORATORIES LTD

CLOZAPINE, CLOZAPINE
DIGOXIN, DIGOXIN
ELIXOPHYLLIN, THEOPHYLLINE
FLUMADINE, RIMANTADINE HYDROCHLORIDE
FLURBIPROFEN, FLURBIPROFEN
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLIPIZIDE, GLIPIZIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
MELOXICAM, MELOXICAM
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHIMAZOLE, METHIMAZOLE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIRTAZAPINE, MIRTAZAPINE
OXAPROZIN, OXAPROZIN
PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
SYNALGOS-DC, ASPIRIN
THEOCHRON, THEOPHYLLINE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

CARDINAL HEALTH 414

* CARDINAL HEALTH 414 LLC
TECHNETIUM TC 99M SESTAMIBI,

TECHNETIUM TC-99M SESTAMIBI KIT

CARDINAL HLTH
* CARDINAL HEALTH
CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CAREFUSION
* CAREFUSION 213 LLC
CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)

PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE (OTC)

CARLSBAD
* CARLSBAD TECHNOLOGY INC
ACYCLOVIR, ACYCLOVIR
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
FAMOTIDINE, FAMOTIDINE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GLIMEPIRIDE, GLIMEPIRIDE
LOVASTATIN, LOVASTATIN
MELOXICAM, MELOXICAM

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

CAROLINA MEDCL
* CAROLINA MEDICAL PRODUCTS CO
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE
ISONIAZID, ISONIAZID
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
SPS, SODIUM POLYSTYRENE SULFONATE

TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE

B - 39

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

CATALENT
* CATALENT PHARMA SOLUTIONS LLC
NIFEDIPINE, NIFEDIPINE

VALPROIC ACID, VALPROIC ACID

CEDAR PHARMS
* CEDAR PHARMACEUTICALS LLC
METHIMAZOLE, METHIMAZOLE

SODIUM POLYSTYRENE SULFONATE,

SODIUM POLYSTYRENE SULFONATE

CELGENE
* CELGENE CORP
ISTODAX, ROMIDEPSIN
REVLIMID, LENALIDOMIDE
THALOMID, THALIDOMIDE

VIDAZA, AZACITIDINE

CEPHALON
* CEPHALON INC
ACTIQ, FENTANYL CITRATE
FENTORA, FENTANYL CITRATE
GABITRIL, TIAGABINE HYDROCHLORIDE
NUVIGIL, ARMODAFINIL
PROVIGIL, MODAFINIL
TREANDA, BENDAMUSTINE HYDROCHLORIDE

TRISENOX, ARSENIC TRIOXIDE

CEPHAZONE PHARMA
* CEPHAZONE PHARMA LLC
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEREXA
* CEREXA INC
TEFLARO,

CEFTAROLINE FOSAMIL

CHATTEM
* CHATTEM INC
SELSUN, SELENIUM SULFIDE

UNISOM, DOXYLAMINE SUCCINATE

(OTC)

CHEMISCH FBRK KRSSLR

* CHEMISCHE FABRIK KREUSSLER & CO. GMBH
ASCLERA, POLIDOCANOL
CHIRHOCLIN
* CHIRHOCLIN INC
CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN
CIPHER PHARMS INC
* CIPHER PHARMACEUTICALS INC
CONZIP, TRAMADOL HYDROCHLORIDE

LIPOFEN, FENOFIBRATE

CIPLA
* CIPLA LTD
RAMIPRIL, RAMIPRIL
RISPERIDONE, RISPERIDONE
TRANDOLAPRIL, TRANDOLAPRIL

ZIDOVUDINE, ZIDOVUDINE

CIPLA LTD
* CIPLA LTD
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
STAVUDINE, STAVUDINE
TOPIRAMATE, TOPIRAMATE
ZALEPLON, ZALEPLON

ZIDOVUDINE, ZIDOVUDINE

B - 40

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 41

PRODUCT NAME SORTED BY APPLICANT

**

**

CITIUS PHARMS
* CITIUS PHARMACEUTICALS LLC
SUPRENZA, PHENTERMINE HYDROCHLORIDE
CITRUSPHRMA
* CITRUSPHRMA LLC
SODIUM POLYSTYRENE SULFONATE,

SODIUM POLYSTYRENE SULFONATE

CLARIS LIFESCIENCES
* CLARIS LIFESCIENCES LTD
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
DIPYRIDAMOLE, DIPYRIDAMOLE
FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK), FAMOTIDINE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FLUMAZENIL, FLUMAZENIL
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
FULCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE
MILRINONE LACTATE, MILRINONE LACTATE
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE
CLINIGEN HLTHCARE
* CLINIGEN HEALTHCARE LTD
FOSCAVIR, FOSCARNET SODIUM
CLINTEC NUTR
* CLINTEC NUTRITION CO SUB CLINIQUE
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER,

AMINO ACIDS

CLONMEL HLTHCARE
* CLONMEL HEALTHCARE LTD
MORPHINE SULFATE, MORPHINE SULFATE
CNS THERAPS INC
* CNS THERAPEUTICS INC
GABLOFEN, BACLOFEN
CNTY LINE PHARMS
* COUNTY LINE PHARMACEUTICALS LLC
UREX, METHENAMINE HIPPURATE
COASTAL PHARMS
* COASTAL PHARMACEUTICALS
BROMFENAC SODIUM, BROMFENAC SODIUM
NYSTATIN, NYSTATIN

OXYCODONE AND ASPIRIN, ASPIRIN

* COASTAL PHARMACEUTICALS INC

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

COBALT LABS INC

* COBALT LABORATORIES INC
LEVETIRACETAM, LEVETIRACETAM

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

COLGATE
* COLGATE ORAL PHARMACEUTICALS INC
ORABASE HCA, HYDROCORTISONE ACETATE

PERIOGARD, CHLORHEXIDINE GLUCONATE

COLGATE PALMOLIVE
* COLGATE PALMOLIVE
COLGATE TOTAL, SODIUM FLUORIDE

(OTC)

CONNECTICS
* CONNECTICS CORP
LUXIQ, BETAMETHASONE VALERATE
CONTRACT PHARMA
* CONTRACT PHARMACAL CORP
CETIRIZINE HYDROCHLORIDE ALLERGY,

CETIRIZINE HYDROCHLORIDE

(OTC)

CONTRACT PHARMACAL
* CONTRACT PHARMACAL CORP
CIMETIDINE, CIMETIDINE (OTC)
FOLIC ACID, FOLIC ACID
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
PREDNISONE, PREDNISONE
PROFEN, IBUPROFEN (OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

CONTROLLED THERAP
* CONTROLLED THERAPEUTICS (SCOTLAND) LTD
CERVIDIL, DINOPROSTONE
COREPHARMA
* COREPHARMA LLC
ALBENZA, ALBENDAZOLE
ALPRAZOLAM, ALPRAZOLAM
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CARISOPRODOL, CARISOPRODOL
CILOSTAZOL, CILOSTAZOL
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DARAPRIM, PYRIMETHAMINE
DECLOMYCIN, DEMECLOCYCLINE HYDROCHLORIDE
DEXEDRINE, DEXTROAMPHETAMINE SULFATE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE,
ASPARTATE
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

E-GLADES, ERYTHROMYCIN

GLIMEPIRIDE, GLIMEPIRIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HYDROCORTISONE, HYDROCORTISONE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LEVOCARNITINE, LEVOCARNITINE

MELOXICAM, MELOXICAM

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

AMPHETAMINE

B - 42

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* COREPHARMA LLC
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRANDOLAPRIL, TRANDOLAPRIL
URSODIOL, URSODIOL

ZONISAMIDE, ZONISAMIDE

CORIA
* CORIA LABORATORIES LTD
NUTRACORT, HYDROCORTISONE
CORNERSTONE THERAP
* CORNERSTONE THERAPEUTICS INC
CUROSURF, PORACTANT ALFA
FACTIVE, GEMIFLOXACIN MESYLATE
SPECTRACEF, CEFDITOREN PIVOXIL
ZYFLO CR, ZILEUTON

ZYFLO, ZILEUTON

COVIDIEN
* COVIDIEN
LYMPHAZURIN, ISOSULFAN BLUE

THERMAZENE, SILVER SULFADIAZINE

COVIS PHARMA
* COVIS PHARMA SARL
LANOXIN PEDIATRIC,
LANOXIN, DIGOXIN

DIGOXIN

CPPI CV
* CP PHARMACEUTICALS INTERNATIONAL CV
LYRICA, PREGABALIN

SUTENT, SUNITINIB MALATE

CROWN LABS
* CROWN LABORATORIES INC
ALA-CORT, HYDROCORTISONE
ALA-SCALP, HYDROCORTISONE

TRIDERM, TRIAMCINOLONE ACETONIDE

CSL BEHRING
* CSL BEHRING LLC
STIMATE (NEEDS NO REFRIGERATION),

DESMOPRESSIN ACETATE

CUBIST
* CUBIST PHARMACEUTICALS INC
CUBICIN, DAPTOMYCIN
CUMBERLAND PHARMS
* CUMBERLAND PHARMACEUTICALS INC
ACETADOTE, ACETYLCYSTEINE

CALDOLOR, IBUPROFEN

CYPRESS BIOSCIENCE
* CYPRESS BIOSCIENCE INC
SAVELLA, MILNACIPRAN HYDROCHLORIDE
CYPRESS PHARM
* CYPRESS PHARMACEUTICAL INC
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ELIPHOS, CALCIUM ACETATE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
REZIRA, HYDROCODONE BITARTRATE

ZUTRIPRO, CHLORPHENIRAMINE MALEATE

B - 43

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

DAIICHI
* DAIICHI PHARMACEUTICAL CORP
FLOXIN OTIC, OFLOXACIN
DAIICHI SANKYO
* DAIICHI SANKYO INC
AZOR, AMLODIPINE BESYLATE
BENICAR HCT, HYDROCHLOROTHIAZIDE
BENICAR, OLMESARTAN MEDOXOMIL
TRIBENZOR, AMLODIPINE BESYLATE

WELCHOL, COLESEVELAM HYDROCHLORIDE

DAIICHI SANKYO CO
* DAIICHI SANKYO CO LTD
EVOXAC, CEVIMELINE HYDROCHLORIDE
DANCO LABS LLC
* DANCO LABORATORIES LLC
MIFEPREX, MIFEPRISTONE
DAVA INTL INC
* DAVA INTERNATIONAL INC
ALPRAZOLAM, ALPRAZOLAM
DAVA PHARMS INC
* DAVA PHARMACEUTICALS INC
ACYCLOVIR, ACYCLOVIR
AMOXICILLIN, AMOXICILLIN
AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE
ATENOLOL, ATENOLOL
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CIMETIDINE, CIMETIDINE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DIAZEPAM, DIAZEPAM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
FUROSEMIDE, FUROSEMIDE
GEMFIBROZIL, GEMFIBROZIL
GLYBURIDE (MICRONIZED), GLYBURIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
NAPROXEN, NAPROXEN
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PROPYLTHIOURACIL, PROPYLTHIOURACIL
PYRAZINAMIDE, PYRAZINAMIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

VOSPIRE ER, ALBUTEROL SULFATE

DAVIS AND GECK

* DAVIS AND GECK DIV AMERICAN CYANAMID CO
PRE-OP II, HEXACHLOROPHENE

PRE-OP, HEXACHLOROPHENE

DENCO ASSET
* DENCO ASSET LLC
DENAVIR, PENCICLOVIR SODIUM
DENTSPLY PHARM
* DENTSPLY PHARMACEUTICAL
CITANEST PLAIN DENTAL, PRILOCAINE HYDROCHLORIDE
ORAQIX, LIDOCAINE
POLOCAINE, MEPIVACAINE HYDROCHLORIDE
XYLOCAINE DENTAL WITH EPINEPHRINE, EPINEPHRINE

XYLOCAINE DENTAL, LIDOCAINE HYDROCHLORIDE

* DENTSPLY PHARMACEUTICAL INC

CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE

B - 44

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

DEPOMED INC
* DEPOMED INC
GRALISE, GABAPENTIN
DEPROCO
* DEPROCO INC
LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE
LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE
SCANDONEST L, LEVONORDEFRIN
SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE

SEPTOCAINE, ARTICAINE HYDROCHLORIDE

DEXCEL LTD
* DEXCEL LTD
DICLOFENAC SODIUM, DICLOFENAC SODIUM

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

DEXCEL PHARMA
* DEXCEL PHARMA TECHNOLOGIES LTD
OMEPRAZOLE, OMEPRAZOLE (OTC)

PERIOCHIP, CHLORHEXIDINE GLUCONATE

DEY
* DEY LP
ACCUNEB, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
CROMOLYN SODIUM, CROMOLYN SODIUM
DUONEB, ALBUTEROL SULFATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

DEY PHARMA
* DEY PHARMA LP
PERFOROMIST,

FORMOTEROL FUMARATE

DIALYSIS SUPS
* DIALYSIS SUPPLIES INC
NORMOCARB HF 25, MAGNESIUM CHLORIDE

NORMOCARB HF 35, MAGNESIUM CHLORIDE

DORC
* DORC INTERNATIONAL BV
MEMBRANEBLUE, TRYPAN BLUE

VISIONBLUE, TRYPAN BLUE

DOW PHARM SCI

* DOW PHARMACEUTICAL SCIENCES
ACANYA, BENZOYL PEROXIDE
DOW PHARM SCIENCES
* DOW PHARMACEUTICAL SCIENCES INC
AKNE-MYCIN, ERYTHROMYCIN
ATRALIN, TRETINOIN

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE,

BENZOYL PEROXIDE

DR REDDYS LA
* DR REDDYS LABORATORIES LOUISIANA LLC
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LOPURIN, ALLOPURINOL
SSD AF, SILVER SULFADIAZINE

SSD, SILVER SULFADIAZINE

DR REDDYS LABS
* DR REDDYS LABORATORIES LTD
OMEPRAZOLE, OMEPRAZOLE
DR REDDYS LABS INC
* DR REDDYS LABORATORIES INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE,

AMLODIPINE BESYLATE

B - 45

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** D

**

* DR REDDYS LABORATORIES INC

AMOXIL, AMOXICILLIN
AUGMENTIN '125', AMOXICILLIN
AUGMENTIN '200', AMOXICILLIN
AUGMENTIN '250', AMOXICILLIN
AUGMENTIN '400', AMOXICILLIN
AUGMENTIN '500', AMOXICILLIN
AUGMENTIN '875', AMOXICILLIN
AUGMENTIN ES-600, AMOXICILLIN
AUGMENTIN XR, AMOXICILLIN
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LAROTID, AMOXICILLIN
LEVOFLOXACIN, LEVOFLOXACIN
MELOXICAM, MELOXICAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
SIMVASTATIN, SIMVASTATIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

DR REDDYS LABS LTD

* DR REDDYS LABORATORIES LIMITED
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
* DR REDDYS LABORATORIES LTD
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE
DESLORATADINE, DESLORATADINE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE
HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

B - 46

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* DR REDDYS LABORATORIES LTD

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FONDAPARINUX SODIUM, FONDAPARINUX SODIUM
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLIMEPIRIDE, GLIMEPIRIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN (OTC)
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
LANSOPRAZOLE, LANSOPRAZOLE
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NABUMETONE, NABUMETONE
NAPROXEN SODIUM, NAPROXEN SODIUM
NATEGLINIDE, NATEGLINIDE
NIZATIDINE, NIZATIDINE
OFLOXACIN, OFLOXACIN
OLANZAPINE, OLANZAPINE
OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXAPROZIN, OXAPROZIN
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PRIMIDONE, PRIMIDONE
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
TACROLIMUS, TACROLIMUS
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
TRANDOLAPRIL, TRANDOLAPRIL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZAFIRLUKAST, ZAFIRLUKAST
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

(OTC)

DRAXIMAGE
* DRAXIMAGE INC
DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE
DTPA, TECHNETIUM TC-99M PENTETATE KIT
HICON, SODIUM IODIDE I-131
SODIUM IODIDE I-131, SODIUM IODIDE I-131
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
DURAMED
* DURAMED PHARMACEUTICALS INC
NORDETTE-28, ETHINYL ESTRADIOL
PLAN B ONE-STEP, LEVONORGESTREL
PLAN B ONE-STEP, LEVONORGESTREL (OTC)

REVIA, NALTREXONE HYDROCHLORIDE

DURAMED PHARMS BARR

* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
AVIANE-28, ETHINYL ESTRADIOL
CRYSELLE, ETHINYL ESTRADIOL
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DIAMOX, ACETAZOLAMIDE

B - 47

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** D

**

* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC

DIAMOX, ACETAZOLAMIDE SODIUM
ENPRESSE-28, ETHINYL ESTRADIOL
METHYLPREDNISOLONE, METHYLPREDNISOLONE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VELIVET, DESOGESTREL
ZEBETA, BISOPROLOL FUMARATE

ZIAC, BISOPROLOL FUMARATE

DURAMED RES
* DURAMED RESEARCH INC
AYGESTIN, NORETHINDRONE ACETATE
PARAGARD T 380A, COPPER

SEASONALE, ETHINYL ESTRADIOL

DUSA
* DUSA PHARMACEUTICALS INC
LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE
EAGLE PHARMS
* EAGLE PHARMACEUTICALS INC
ARGATROBAN IN SODIUM CHLORIDE,

ARGATROBAN

EASTMAN KODAK
* EASTMAN KODAK CO
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE,

EPINEPHRINE

EBEWE PHARMA
* EBEWE PHARMA
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
* EBEWE PHARMA GES MBH NFG KG
CARBOPLATIN, CARBOPLATIN
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FLUOROURACIL, FLUOROURACIL
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ECOLAB
* ECOLAB INC
CHG SCRUB,
CIDA-STAT,

CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATE

(OTC)

(OTC)

ECR
* ECR PHARMACEUTICALS
DEXAMETHASONE, DEXAMETHASONE
EDGEMONT PHARMS LLC
* EDGEMONT PHARMACEUTICALS LLC
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
EGIS
* EGIS PHARMACEUTICALS
BUSPIRONE HYDROCHLORIDE,
EI INC
* EI INC
THEROXIDIL,

MINOXIDIL

BUSPIRONE HYDROCHLORIDE

(OTC)

EISAI INC
* EISAI INC
ACIPHEX, RABEPRAZOLE SODIUM
ARICEPT ODT, DONEPEZIL HYDROCHLORIDE
ARICEPT, DONEPEZIL HYDROCHLORIDE
BANZEL, RUFINAMIDE
DACOGEN, DECITABINE
FRAGMIN, DALTEPARIN SODIUM

GLIADEL, CARMUSTINE

B - 48

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* EISAI INC
HALAVEN, ERIBULIN MESYLATE
HEXALEN, ALTRETAMINE
LUSEDRA, FOSPROPOFOL DISODIUM
PANRETIN, ALITRETINOIN
SALAGEN, PILOCARPINE HYDROCHLORIDE
TARGRETIN, BEXAROTENE

ZONEGRAN, ZONISAMIDE

EKR THERAP
* EKR THERAPEUTICS INC
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE SR, NICARDIPINE HYDROCHLORIDE
CARDENE, NICARDIPINE HYDROCHLORIDE

DEPODUR, MORPHINE SULFATE

ELAN DRUG
* ELAN DRUG DELIVERY INC
VERELAN PM, VERAPAMIL HYDROCHLORIDE
ELAN PHARM
* ELAN PHARMACEUTICAL RESEARCH CORP
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

KETOPROFEN, KETOPROFEN

ELI LILLY AND CO

* ELI LILLY AND CO
AXIRON, TESTOSTERONE

EFFIENT, PRASUGREL HYDROCHLORIDE

ELI LILLY CO
* ELI LILLY CO
ADCIRCA, TADALAFIL

ZYPREXA RELPREVV, OLANZAPINE PAMOATE

ELITE LABS
* ELITE LABORATORIES INC
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

ELKINS SINN
* ELKINS SINN DIV AH ROBINS CO INC
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
EMCURE PHARMS
* EMCURE PHARMACEUTICALS LTD
ONDANSETRON HYDROCHLORIDE,

ONDANSETRON HYDROCHLORIDE

EMCURE PHARMS USA

* EMCURE PHARMACEUTICALS USA INC
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL
METHIMAZOLE, METHIMAZOLE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

EMCURE USA
* EMCURE PHARMACEUTICALS USA INC
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
EMD SERONO
* EMD SERONO INC
CETROTIDE, CETRORELIX
GONAL-F RFF PEN, FOLLITROPIN ALFA/BETA
GONAL-F RFF, FOLLITROPIN ALFA/BETA
GONAL-F, FOLLITROPIN ALFA/BETA
LUVERIS, LUTROPIN ALFA
OVIDREL, CHORIOGONADOTROPIN ALFA

SAIZEN, SOMATROPIN RECOMBINANT

B - 49

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* EMD SERONO INC

SEROPHENE, CLOMIPHENE CITRATE
SEROSTIM, SOMATROPIN RECOMBINANT

ZORBTIVE, SOMATROPIN RECOMBINANT

EMMAUS MEDCL
* EMMAUS MEDICAL INC
NUTRESTORE, GLUTAMINE
ENDO PHARM
* ENDO PHARMACEUTICAL SOLUTIONS INC
DELATESTRYL, TESTOSTERONE ENANTHATE
SUPPRELIN LA, HISTRELIN ACETATE
VALSTAR PRESERVATIVE FREE, VALRUBICIN

VANTAS, HISTRELIN ACETATE

ENDO PHARMS
* ENDO PHARMACEUTICALS INC
FELODIPINE, FELODIPINE
FORTESTA, TESTOSTERONE
FROVA, FROVATRIPTAN SUCCINATE
LETROZOLE, LETROZOLE
MORPHINE SULFATE, MORPHINE SULFATE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
OPANA ER, OXYMORPHONE HYDROCHLORIDE
OPANA, OXYMORPHONE HYDROCHLORIDE
PERCOCET, ACETAMINOPHEN
PERCODAN, ASPIRIN

ZYDONE, ACETAMINOPHEN

EPIC PHARMA
* EPIC PHARMA INC
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

* EPIC PHARMA LLC

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
SULINDAC, SULINDAC
TRANDOLAPRIL, TRANDOLAPRIL

URSODIOL, URSODIOL

EPIC PHARMA LLC

* EPIC PHARMA LLC
AMLODIPINE BESYLATE,

AMLODIPINE BESYLATE

ERGOJECT
* ERGOJECT LLC
METHYLERGONOVINE MALEATE,

METHYLERGONOVINE MALEATE

ETHYPHARM
* ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE,
EURAND
* EURAND AMERICA INC
POTASSIUM CHLORIDE,

BUPRENORPHINE HYDROCHLORIDE

POTASSIUM CHLORIDE

EUSA PHARMA USA

* EUSA PHARMA (USA) INC
QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
EXALENZ BIOSCIENCE
* EXALENZ BIOSCIENCE LTD
IDKIT:HP, UREA C-13
EXCELLIUM
* EXCELLIUM PHARMACEUTICAL INC
FOLIC ACID, FOLIC ACID

FUROSEMIDE, FUROSEMIDE

B - 50

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

EXCELLIUM PHARMACEUTICAL INC

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LORAZEPAM, LORAZEPAM

EXELA PHARMA SCIENCE

* EXELA PHARMA SCIENCES
NICARDIPINE HYDROCHLORIDE,

NICARDIPINE HYDROCHLORIDE

EYETECH INC
* EYETECH INC
MACUGEN, PEGAPTANIB SODIUM
FACTA FARMA
* FACTA FARMACEUTICI SPA
CEPHALEXIN, CEPHALEXIN
FALCON PHARMS
* FALCON PHARMACEUTICALS INC
TIMOLOL MALEATE, TIMOLOL MALEATE
* FALCON PHARMACEUTICALS LTD
DIPIVEFRIN HYDROCHLORIDE, DIPIVEFRIN HYDROCHLORIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE
MAXITROL, DEXAMETHASONE
METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
TIMOLOL MALEATE, TIMOLOL MALEATE
TOBREX, TOBRAMYCIN

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

FDC LTD
* FDC LTD
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
OFLOXACIN, OFLOXACIN

TIMOLOL MALEATE, TIMOLOL MALEATE

FEINSTEIN
* FEINSTEIN INSTITUTE MEDICAL RESEARCH
AMMONIA N 13, AMMONIA, N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

FERA PHARMS
* FERA PHARMACEUTICALS LLC
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BACITRACIN, BACITRACIN
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN
ERYTHROMYCIN, ERYTHROMYCIN
GENTAMICIN SULFATE, GENTAMICIN SULFATE
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE
OFLOXACIN, OFLOXACIN
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TOBRAMYCIN, TOBRAMYCIN

FERNDALE LABS
* FERNDALE LABORATORIES INC
HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE
MICORT-HC, HYDROCORTISONE ACETATE

PRAMOSONE, HYDROCORTISONE ACETATE

FERRING
* FERRING PHARMACEUTICALS INC
ACTHREL, CORTICORELIN OVINE TRIFLUTATE
BRAVELLE, UROFOLLITROPIN
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
ENDOMETRIN, PROGESTERONE
FIRMAGON, DEGARELIX ACETATE
MENOPUR, LUTEINIZING HORMONE
MINIRIN, DESMOPRESSIN ACETATE

REPRONEX, LUTEINIZING HORMONE

B - 51

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* FERRING PHARMACEUTICALS INC

TEV-TROPIN, SOMATROPIN RECOMBINANT
FERRING PHARMS AS
* FERRING PHARMACEUTICALS AS
LYSTEDA, TRANEXAMIC ACID
FLEMING
* FLEMING AND CO PHARMACEUTICALS
THYROSHIELD, POTASSIUM IODIDE

(OTC)

FOREST LABS
* FOREST LABORATORIES INC
BYSTOLIC, NEBIVOLOL HYDROCHLORIDE
CAMPRAL, ACAMPROSATE CALCIUM
CELEXA, CITALOPRAM HYDROBROMIDE
LEXAPRO, ESCITALOPRAM OXALATE
NAMENDA XR, MEMANTINE HYDROCHLORIDE
NAMENDA, MEMANTINE HYDROCHLORIDE
TESSALON, BENZONATATE
THYROLAR-0.25, LIOTHYRONINE SODIUM
THYROLAR-0.5, LIOTHYRONINE SODIUM
THYROLAR-1, LIOTHYRONINE SODIUM
THYROLAR-2, LIOTHYRONINE SODIUM

THYROLAR-3, LIOTHYRONINE SODIUM

FOREST LABS INC

* FOREST LABORATORIES INC
VIIBRYD, VILAZODONE HYDROCHLORIDE
FOREST RES INST INC
* FOREST RESEARCH INSTITUTE INC
DALIRESP, ROFLUMILAST
FOUGERA
* E FOUGERA DIV ALTANA INC
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE, FLUOCINONIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HYDROCORTISONE, HYDROCORTISONE
LIDOCAINE, LIDOCAINE
NITROGLYCERIN, NITROGLYCERIN
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

FOUGERA PHARMS
* FOUGERA PHARMACEUTICALS INC
ACLOVATE, ALCLOMETASONE DIPROPIONATE
CUTIVATE, FLUTICASONE PROPIONATE
ERYTHROMYCIN, ERYTHROMYCIN
OXISTAT, OXICONAZOLE NITRATE
PAMINE FORTE, METHSCOPOLAMINE BROMIDE
PAMINE, METHSCOPOLAMINE BROMIDE
PANDEL, HYDROCORTISONE PROBUTATE
SOLARAZE, DICLOFENAC SODIUM

TEMOVATE E, CLOBETASOL PROPIONATE

FRESENIUS
* FRESENIUS KABI DEUTSCHLAND GMBH
INTRALIPID 10%, SOYBEAN OIL
INTRALIPID 20%, SOYBEAN OIL

INTRALIPID 30%, SOYBEAN OIL

* FRESENIUS USA INC

INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER,
INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER,

CALCIUM CHLORIDE
CALCIUM CHLORIDE

B - 52

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

B - 53

**

FRESENIUS USA INC

INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

FRESENIUS KABI ONCOL

* FRESENIUS KABI ONCOLOGY PLC
ANASTROZOLE, ANASTROZOLE
BICALUTAMIDE, BICALUTAMIDE
CARBOPLATIN, CARBOPLATIN
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LETROZOLE, LETROZOLE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

FRESENIUS MEDCL
* FRESENIUS MEDICAL CARE NORTH AMERICA
CALCITRIOL, CALCITRIOL
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM
CHLORIDE
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PHOSLO GELCAPS, CALCIUM ACETATE

PHOSLYRA, CALCIUM ACETATE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

FSC
* FSC LABORATORIES INC
PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE
FUTURE PAK
* FUTURE PAK LTD
K+10, POTASSIUM CHLORIDE
G AND W LABS
* G AND W LABORATORIES INC
ACEPHEN, ACETAMINOPHEN (OTC)
CICLOPIROX, CICLOPIROX
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
INDOMETHACIN, INDOMETHACIN
METRONIDAZOLE, METRONIDAZOLE
MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
MIGERGOT, CAFFEINE
MOMETASONE FUROATE, MOMETASONE FUROATE
PROCHLORPERAZINE, PROCHLORPERAZINE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

G AND W LABS INC

* G AND W LABORATORIES INC
CALCIPOTRIENE, CALCIPOTRIENE
CICLOPIROX, CICLOPIROX

METRONIDAZOLE, METRONIDAZOLE

GALDERMA LABS
* GALDERMA LABORATORIES INC
CLOBEX, CLOBETASOL PROPIONATE

EPIDUO, ADAPALENE

GALDERMA LABS LP
* GALDERMA LABORATORIES L P
CLOBEX, CLOBETASOL PROPIONATE
* GALDERMA LABORATORIES LP
CAPEX, FLUOCINOLONE ACETONIDE
CLINDAGEL, CLINDAMYCIN PHOSPHATE
CLOBEX, CLOBETASOL PROPIONATE
DESOWEN, DESONIDE
DIFFERIN, ADAPALENE
LIDOCAINE AND TETRACAINE, LIDOCAINE
METROCREAM, METRONIDAZOLE
METROGEL, METRONIDAZOLE
METROLOTION, METRONIDAZOLE
METVIXIA, METHYL AMINOLEVULINATE HYDROCHLORIDE
ORACEA, DOXYCYCLINE
PERIOSTAT, DOXYCYCLINE HYCLATE
TRI-LUMA, FLUOCINOLONE ACETONIDE

VECTICAL, CALCITRIOL

GALDERMA R AND D
* GALDERMA RESEARCH AND DEVELOPMENT INC
DIFFERIN, ADAPALENE
GALEN (UK)
* GALEN LTD
DAUNOXOME,
GALEN LTD
* GALEN LTD
FEMRING,

DAUNORUBICIN CITRATE

ESTRADIOL ACETATE

GAMBRO RENAL PRODS

* GAMBRO RENAL PRODUCTS
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

GASTROENTERO
* GASTROENTERO LOGIC LLC
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN,

AMOXICILLIN

GAVIS PHARMS
* GAVIS PHARMACEUTICALS LLC
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
PENTAZOCINE AND NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
QUINARETIC, HYDROCHLOROTHIAZIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

B - 54

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

GD SEARLE
* GD SEARLE LLC
CELEBREX, CELECOXIB

DAYPRO, OXAPROZIN

GD SEARLE LLC
* GD SEARLE LLC
ALDACTAZIDE, HYDROCHLOROTHIAZIDE
ALDACTONE, SPIRONOLACTONE
ARTHROTEC, DICLOFENAC SODIUM
CALAN, VERAPAMIL HYDROCHLORIDE
COVERA-HS, VERAPAMIL HYDROCHLORIDE
CYTOTEC, MISOPROSTOL
FLAGYL ER, METRONIDAZOLE
FLAGYL, METRONIDAZOLE
INSPRA, EPLERENONE
LOMOTIL, ATROPINE SULFATE
NORPACE CR, DISOPYRAMIDE PHOSPHATE
NORPACE, DISOPYRAMIDE PHOSPHATE

SYNAREL, NAFARELIN ACETATE

GE HEALTHCARE
* GE HEALTHCARE
ADREVIEW, IOBENGUANE SULFATE I-123
CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT
CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE
INDICLOR, INDIUM IN-111 CHLORIDE
INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE
METASTRON, STRONTIUM CHLORIDE SR-89
MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT
MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM
MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT
MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT
OMNIPAQUE 140, IOHEXOL
OMNIPAQUE 180, IOHEXOL
OMNIPAQUE 240, IOHEXOL
OMNIPAQUE 300, IOHEXOL
OMNIPAQUE 350, IOHEXOL
OMNISCAN, GADODIAMIDE
OPTISON, ALBUMIN HUMAN
SODIUM IODIDE I 123, SODIUM IODIDE I-123
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
VISIPAQUE 270, IODIXANOL

VISIPAQUE 320, IODIXANOL

GE HLTHCARE INC
* GE HEALTHCARE INC
DATSCAN, IOFLUPANE I-123
GEDEON RICHTER USA
* GEDEON RICHTER USA INC
FINASTERIDE, FINASTERIDE
GENENTECH
* GENENTECH INC
NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT
NUTROPIN AQ, SOMATROPIN RECOMBINANT

NUTROPIN, SOMATROPIN RECOMBINANT

GENERAMEDIX
* GENERAMEDIX INC
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE,
GENTA
* GENTA INC
GANITE,

GALLIUM NITRATE

SODIUM FERRIC GLUCONATE COMPLEX

B - 55

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

GENZYME
* GENZYME CORP
CEREDASE, ALGLUCERASE
CEREZYME, IMIGLUCERASE
CLOLAR, CLOFARABINE
FLUDARA, FLUDARABINE PHOSPHATE
MOZOBIL, PLERIXAFOR
RENAGEL, SEVELAMER HYDROCHLORIDE
RENVELA, SEVELAMER CARBONATE

THYROGEN, THYROTROPIN ALFA

GENZYME CORP
* GENZYME CORP
HECTOROL, DOXERCALCIFEROL
* GENZYME CORPORATION
HECTOROL, DOXERCALCIFEROL
GILEAD
* GILEAD SCIENCES INC
ATRIPLA, EFAVIRENZ
CAYSTON, AZTREONAM
EMTRIVA, EMTRICITABINE
HEPSERA, ADEFOVIR DIPIVOXIL
LETAIRIS, AMBRISENTAN
RANEXA, RANOLAZINE
TRUVADA, EMTRICITABINE
VIREAD, TENOFOVIR DISOPROXIL FUMARATE

VISTIDE, CIDOFOVIR

GILEAD SCIENCES INC

* GILEAD SCIENCES INC
COMPLERA, EMTRICITABINE
GLAND PHARMA LTD
* GLAND PHARMA LTD
ADENOSINE, ADENOSINE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AZITHROMYCIN, AZITHROMYCIN
HALOPERIDOL, HALOPERIDOL LACTATE
MILRINONE LACTATE, MILRINONE LACTATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

GLAXO GRP LTD

* GLAXO GROUP LTD
HORIZANT, GABAPENTIN ENACARBIL
* GLAXO GROUP LTD DBA GLAXOSMITHKLINE
ALTABAX, RETAPAMULIN
FLOVENT HFA, FLUTICASONE PROPIONATE

SEREVENT, SALMETEROL XINAFOATE

GLAXOSMITHKLINE
* GLAXOSMITHKLINE
ABREVA, DOCOSANOL (OTC)
ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE
ADVAIR HFA, FLUTICASONE PROPIONATE
ALKERAN, MELPHALAN
ALKERAN, MELPHALAN HYDROCHLORIDE
AMERGE, NARATRIPTAN HYDROCHLORIDE
ARIXTRA, FONDAPARINUX SODIUM
AVODART, DUTASTERIDE
BACTROBAN, MUPIROCIN
BACTROBAN, MUPIROCIN CALCIUM
BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE
CEFTIN, CEFUROXIME AXETIL

EPIVIR-HBV, LAMIVUDINE

B - 56

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* GLAXOSMITHKLINE
FLONASE, FLUTICASONE PROPIONATE
FLOVENT DISKUS 100, FLUTICASONE PROPIONATE
FLOVENT DISKUS 250, FLUTICASONE PROPIONATE
FLOVENT DISKUS 50, FLUTICASONE PROPIONATE
FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM
FORTAZ, CEFTAZIDIME
HYCAMTIN, TOPOTECAN HYDROCHLORIDE
IMITREX STATDOSE, SUMATRIPTAN SUCCINATE
IMITREX, SUMATRIPTAN
IMITREX, SUMATRIPTAN SUCCINATE
JALYN, DUTASTERIDE
LAMICTAL CD, LAMOTRIGINE
LAMICTAL, LAMOTRIGINE
MALARONE PEDIATRIC, ATOVAQUONE
MALARONE, ATOVAQUONE
NICORETTE (MINT), NICOTINE POLACRILEX (OTC)
NICORETTE, NICOTINE POLACRILEX (OTC)
PARNATE, TRANYLCYPROMINE SULFATE
PAXIL CR, PAROXETINE HYDROCHLORIDE
PAXIL, PAROXETINE HYDROCHLORIDE
PROMACTA, ELTROMBOPAG OLAMINE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
RELENZA, ZANAMIVIR
REQUIP, ROPINIROLE HYDROCHLORIDE
TAGAMET HB, CIMETIDINE (OTC)
TAGAMET, CIMETIDINE
THIOGUANINE, THIOGUANINE
TIMENTIN IN PLASTIC CONTAINER, CLAVULANATE POTASSIUM
TIMENTIN, CLAVULANATE POTASSIUM
TREXIMET, NAPROXEN SODIUM
VALTREX, VALACYCLOVIR HYDROCHLORIDE
VENTOLIN HFA, ALBUTEROL SULFATE
VERAMYST, FLUTICASONE FUROATE
VOTRIENT, PAZOPANIB HYDROCHLORIDE
WELLBUTRIN SR, BUPROPION HYDROCHLORIDE
WELLBUTRIN, BUPROPION HYDROCHLORIDE
ZANTAC 150, RANITIDINE HYDROCHLORIDE
ZANTAC 25, RANITIDINE HYDROCHLORIDE
ZANTAC 300, RANITIDINE HYDROCHLORIDE
ZANTAC IN PLASTIC CONTAINER, RANITIDINE HYDROCHLORIDE
ZANTAC, RANITIDINE HYDROCHLORIDE
ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM
ZINACEF, CEFUROXIME SODIUM
ZOFRAN ODT, ONDANSETRON
ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ZOFRAN, ONDANSETRON HYDROCHLORIDE
ZOVIRAX, ACYCLOVIR

ZYBAN, BUPROPION HYDROCHLORIDE

GLAXOSMITHKLINE CONS
* GLAXOSMITHKLINE CONSUMER HEALTHCARE
ALLI, ORLISTAT (OTC)
COMMIT, NICOTINE POLACRILEX (OTC)

NICORETTE, NICOTINE POLACRILEX (OTC)

GLAXOSMITHKLINE LLC
* GLAXOSMITHKLINE LLC
DYAZIDE, HYDROCHLOROTHIAZIDE
DYNACIRC CR, ISRADIPINE
FLOLAN, EPOPROSTENOL SODIUM
INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE
MEPRON, ATOVAQUONE
RYTHMOL SR, PROPAFENONE HYDROCHLORIDE

RYTHMOL, PROPAFENONE HYDROCHLORIDE

B - 57

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

GLENMARK GENERICS
* GLENMARK GENERICS INC USA
ADAPALENE, ADAPALENE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CALCIPOTRIENE, CALCIPOTRIENE
DIPYRIDAMOLE, DIPYRIDAMOLE
MOMETASONE FUROATE, MOMETASONE FUROATE
NILSTAT, NYSTATIN
NIZATIDINE, NIZATIDINE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

* GLENMARK GENERICS LIMITED

BRIELLYN, ETHINYL ESTRADIOL
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

* GLENMARK GENERICS LTD

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE
CARVEDILOL, CARVEDILOL
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
FELODIPINE, FELODIPINE
FLUCONAZOLE, FLUCONAZOLE
GABAPENTIN, GABAPENTIN
HEATHER, NORETHINDRONE
LAMOTRIGINE, LAMOTRIGINE
LEVOFLOXACIN, LEVOFLOXACIN
LITHIUM CARBONATE, LITHIUM CARBONATE
MELOXICAM, MELOXICAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MOMETASONE FUROATE, MOMETASONE FUROATE
NAPROXEN SODIUM, NAPROXEN SODIUM
NAPROXEN, NAPROXEN
NORETHIDRONE, NORETHINDRONE
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
OXCARBAZEPINE, OXCARBAZEPINE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
TOPIRAMATE, TOPIRAMATE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
URSODIOL, URSODIOL

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

* GLENMARK GENERICS LTD INDIA

INDOMETHACIN, INDOMETHACIN
LITHIUM CARBONATE, LITHIUM CARBONATE
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

GLENMARK PHARMS
* GLENMARK PHARMACEUTICALS INC USA
CICLOPIROX, CICLOPIROX
CLOTRIMAZOLE, CLOTRIMAZOLE

MUPIROCIN, MUPIROCIN

* GLENMARK PHARMACEUTICALS LTD

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE,
GLENMARK PHARMS LTD
* GLENMARK PHARMACEUTICALS LTD
HYDRALAZINE HYDROCHLORIDE,

HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE

B - 58

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

GRACEWAY
* GRACEWAY PHARMACEUTICALS LLC
MINITRAN, NITROGLYCERIN

THEOLAIR, THEOPHYLLINE

GRANULES INDIA
* GRANULES INDIA LTD
IBUPROFEN, IBUPROFEN (OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

GRIFFEN
* KW GRIFFEN CO
BIOSCRUB, CHLORHEXIDINE GLUCONATE
GTX INC
* GTX INC
FARESTON,

(OTC)

TOREMIFENE CITRATE

GUARDIAN DRUG
* GUARDIAN DRUG CO INC
FOAMCOAT, ALUMINUM HYDROXIDE

(OTC)

GUERBET
* GUERBET LLC
HEXABRIX, IOXAGLATE MEGLUMINE
OXILAN-300, IOXILAN

OXILAN-350, IOXILAN

HAEMONETICS
* HAEMONETICS CORP
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

SODIUM CHLORIDE

HALOCARBON PRODS
* HALOCARBON PRODUCTS CORP
ISOFLURANE, ISOFLURANE

SEVOFLURANE, SEVOFLURANE

HALOZYME THERAP
* HALOZYME THERAPEUTICS INC
HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN
HANFORD GC
* GC HANFORD MANUFACTURING CO
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

HARRIS PHARM
* HARRIS PHARMACEUTICAL INC
TERBINAFINE HYDROCHLORIDE,
HEC PHARM INC
* HEC PHARM INC
ZIDOVUDINE,

TERBINAFINE HYDROCHLORIDE

ZIDOVUDINE

HELSINN HLTHCARE
* HELSINN HEALTHCARE SA
ALOXI, PALONOSETRON HYDROCHLORIDE
HEMOFARM
* HEMOFARM AD
A-METHAPRED,

METHYLPREDNISOLONE SODIUM SUCCINATE

HERCON LABS
* HERCON LABORATORIES CORP
NITROGLYCERIN, NITROGLYCERIN
HERITAGE PHARMS INC
* HERITAGE PHARMACEUTICALS INC
ACETAZOLAMIDE, ACETAZOLAMIDE
CARISOPRODOL AND ASPIRIN, ASPIRIN

DOXYCYCLINE, DOXYCYCLINE

B - 59

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* HERITAGE PHARMACEUTICALS INC

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLYBURIDE, GLYBURIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
KETOPROFEN, KETOPROFEN
LEFLUNOMIDE, LEFLUNOMIDE
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE

HETERO DRUGS
* HETERO DRUGS LTD
METHOCARBAMOL, METHOCARBAMOL
STAVUDINE, STAVUDINE

TORSEMIDE, TORSEMIDE

HETERO DRUGS LTD

* HETERO DRUGS LTD UNIT III
FINASTERIDE, FINASTERIDE
LEVETIRACETAM, LEVETIRACETAM
LITHIUM CARBONATE, LITHIUM CARBONATE

ZIDOVUDINE, ZIDOVUDINE

HETERO LABS UNIT III

* HETERO LABS LTD UNIT III
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

HEYL CHEMISCH
* HEYL CHEMISCH PHARMAZEUTISHE FABRIK
RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)
HH AND P
* HH AND P LLC
CROMOLYN SODIUM, CROMOLYN SODIUM
FLUNISOLIDE, FLUNISOLIDE

(OTC)

HI TECH PHARMA
* HI TECH PHARMACAL CO INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACYCLOVIR, ACYCLOVIR
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
CALCIPOTRIENE, CALCIPOTRIENE
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CICLOPIROX, CICLOPIROX
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CORMAX, CLOBETASOL PROPIONATE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
EMBELINE E, CLOBETASOL PROPIONATE
EMBELINE, CLOBETASOL PROPIONATE
ERYTHRO-STATIN, ERYTHROMYCIN
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
GABAPENTIN, GABAPENTIN
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LACTULOSE, LACTULOSE
LEVOCARNITINE, LEVOCARNITINE
LEVOFLOXACIN, LEVOFLOXACIN
LIDOCAINE AND PRILOCAINE, LIDOCAINE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

B - 60

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

HI TECH PHARMACAL CO INC

MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)
NYSTATIN, NYSTATIN
OFLOXACIN, OFLOXACIN
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE, PREDNISOLONE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN
HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TIMOLOL MALEATE, TIMOLOL MALEATE

VOSOL HC, ACETIC ACID, GLACIAL

VOSOL, ACETIC ACID, GLACIAL

HIGH TECH PHARMA

* HIGH TECHNOLOGY PHARMACAL CO INC
VALPROIC ACID, VALPROIC ACID
HIKMA
* HIKMA FARMACEUTICA LDA
CEFOTAXIME, CEFOTAXIME SODIUM
* HIKMA PHARMACEUTICALS
AMOXICILLIN, AMOXICILLIN
CARVEDILOL, CARVEDILOL
CEFACLOR, CEFACLOR
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEPHALEXIN, CEPHALEXIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
GLYBURIDE (MICRONIZED), GLYBURIDE
NAPROXEN SODIUM, NAPROXEN SODIUM

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

HIKMA FARMACEUTICA
* HIKMA FARMACEUTICA (PORTUGAL) SA
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CEFOXITIN, CEFOXITIN SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
ENALAPRILAT, ENALAPRILAT
FLUMAZENIL, FLUMAZENIL
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISTERON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE
MILRINONE LACTATE, MILRINONE LACTATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PROGESTERONE, PROGESTERONE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE

VALPROATE SODIUM, VALPROATE SODIUM

* HIKMA FARMACEUTICA PORTUGAL LDA

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

B - 61

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

* HIKMA FARMACEUTICA SA
BUTORPHANOL TARTRATE,

**

BUTORPHANOL TARTRATE

HIKMA PHARMS
* HIKMA PHARMACEUTICALS
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
CEPHALEXIN, CEPHALEXIN
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
GEMFIBROZIL, GEMFIBROZIL
LAMOTRIGINE, LAMOTRIGINE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

HILL DERMAC
* HILL DERMACEUTICALS INC
DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE

DERMOTIC, FLUOCINOLONE ACETONIDE

HISAMITSU
* HISAMITSU PHARMACEUTICAL CO INC
SALONPAS, MENTHOL (OTC)
HITECH PHARMA
* HITECH PHARMACAL CORP
CIPROFLOXACIN HYDROCHLORIDE,

CIPROFLOXACIN HYDROCHLORIDE

HI-TECH PHARMA CO
* HI-TECH PHARMACAL CO INC
TUSSICAPS, CHLORPHENIRAMINE POLISTIREX
HOFFMANN LA ROCHE
* HOFFMANN LA ROCHE INC
INVIRASE, SAQUINAVIR MESYLATE
ROCEPHIN, CEFTRIAXONE SODIUM
ROMAZICON, FLUMAZENIL
XELODA, CAPECITABINE
XENICAL, ORLISTAT

ZELBORAF, VEMURAFENIB

HOPE PHARMS
* HOPE PHARMACEUTICALS
NITHIODOTE, SODIUM NITRITE
HORIZON PHARMA
* HORIZON PHARMA INC
DUEXIS, FAMOTIDINE
HOSPIRA
* HOSPIRA INC
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
ACETYLCYSTEINE, ACETYLCYSTEINE
A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE
ALFENTANIL, ALFENTANIL HYDROCHLORIDE
A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE
AMIDATE, ETOMIDATE
AMIKACIN SULFATE, AMIKACIN SULFATE
AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID
AMINOPHYLLINE, AMINOPHYLLINE
AMINOSYN 10% (PH6), AMINO ACIDS
AMINOSYN 10%, AMINO ACIDS
AMINOSYN 3.5% M, AMINO ACIDS
AMINOSYN 3.5%, AMINO ACIDS
AMINOSYN 5%, AMINO ACIDS
AMINOSYN 7% (PH6), AMINO ACIDS
AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN 7%, AMINO ACIDS
AMINOSYN 8.5% (PH6), AMINO ACIDS

AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS

B - 62

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 63

PRODUCT NAME SORTED BY APPLICANT

**

**

* HOSPIRA INC
AMINOSYN 8.5%, AMINO ACIDS
AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 10%, AMINO ACIDS
AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 7%, AMINO ACIDS
AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 8.5%, AMINO ACIDS
AMINOSYN-HBC 7%, AMINO ACIDS
AMINOSYN-HF 8%, AMINO ACIDS
AMINOSYN-PF 10%, AMINO ACIDS
AMINOSYN-PF 7%, AMINO ACIDS
AMINOSYN-RF 5.2%, AMINO ACIDS
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE
AQUASOL A, VITAMIN A PALMITATE
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE
ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE
AZITHROMYCIN, AZITHROMYCIN
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BUMETANIDE, BUMETANIDE
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CARBOCAINE, MEPIVACAINE HYDROCHLORIDE
CARBOPLATIN, CARBOPLATIN
CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE
CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CORLOPAM, FENOLDOPAM MESYLATE
CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE
CYTARABINE, CYTARABINE
DACARBAZINE, DACARBAZINE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 25%, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DIAZEPAM, DIAZEPAM
DIGOXIN, DIGOXIN
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 64

PRODUCT NAME SORTED BY APPLICANT

**

**

* HOSPIRA INC
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%, DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE
DROPERIDOL, DROPERIDOL
ENALAPRILAT, ENALAPRILAT
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
ERYC, ERYTHROMYCIN
ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
FENTANYL CITRATE, FENTANYL CITRATE
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FOSCARNET SODIUM, FOSCARNET SODIUM
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FUROSEMIDE, FUROSEMIDE
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
ISOFLURANE, ISOFLURANE
ISUPREL, ISOPROTERENOL HYDROCHLORIDE
KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LEVOPHED, NOREPINEPHRINE BITARTRATE
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LIPOSYN II 10%, SAFFLOWER OIL
LIPOSYN II 20%, SAFFLOWER OIL
LIPOSYN III 10%, SOYBEAN OIL
LIPOSYN III 20%, SOYBEAN OIL
LIPOSYN III 30%, SOYBEAN OIL
LORAZEPAM, LORAZEPAM

LTA II KIT, LIDOCAINE HYDROCHLORIDE

M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID

M.V.I. ADULT, ASCORBIC ACID
M.V.I. PEDIATRIC, ASCORBIC ACID

M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 65

PRODUCT NAME SORTED BY APPLICANT

**

**

* HOSPIRA INC
MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE
MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 25%, MANNITOL
MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
MARCAINE, BUPIVACAINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
MORPHINE SULFATE, MORPHINE SULFATE
NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN
NITROGLYCERIN, NITROGLYCERIN
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PACLITAXEL, PACLITAXEL
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PANCURONIUM BROMIDE, PANCURONIUM BROMIDE
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE
POTASSIUM ACETATE IN PLASTIC CONTAINER, POTASSIUM ACETATE

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM

CHLORIDE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DEXTROSE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 66

PRODUCT NAME SORTED BY APPLICANT

**

**

* HOSPIRA INC
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
DEXTROSE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPOFOL, PROPOFOL
QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE
QUELICIN, SUCCINYLCHOLINE CHLORIDE
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS
SODIUM BICARBONATE, SODIUM BICARBONATE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
SUFENTANIL CITRATE, SUFENTANIL CITRATE
TALWIN, PENTAZOCINE LACTATE
TAZICEF, CEFTAZIDIME
THAM, TROMETHAMINE
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* HOSPIRA INC
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
VITAMIN K1, PHYTONADIONE

ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE

* HOSPIRA WORLDWIDE, INC

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NITROPRESS, SODIUM NITROPRUSSIDE
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER,
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE

ONDANSETRON HYDROCHLORIDE

HOSPIRA INC
* HOSPIRA INC
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFOXITIN, CEFOXITIN SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM
DOCETAXEL, DOCETAXEL
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GEMCITABINE, GEMCITABINE HYDROCHLORIDE
HEPARIN SODIUM, HEPARIN SODIUM
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IMIPENEM AND CILASTATIN, CILASTATIN SODIUM
MAXIPIME, CEFEPIME HYDROCHLORIDE
MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
MEROPENEM, MEROPENEM
MORPHINE SULFATE, MORPHINE SULFATE
NIPENT, PENTOSTATIN
OXALIPLATIN, OXALIPLATIN
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
TOPOTECAN, TOPOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

HOSPIRA WORLDWIDE
* HOSPIRA WORLDWIDE PTY
OXALIPLATIN, OXALIPLATIN
HQ SPECIALITY PHARMA
* HQ SPECIALITY PHARMA LLC
LEVETIRACETAM IN SODIUM CHLORIDE,
HUAHAI US INC
* HUAHAI US INC
DONEPEZIL HYDROCHLORIDE,

LEVETIRACETAM

DONEPEZIL HYDROCHLORIDE

IBI
* ISTITUTO BIOCHIMICO ITALIANO SPA
AMPICILLIN SODIUM, AMPICILLIN SODIUM

NAFCILLIN SODIUM, NAFCILLIN SODIUM

IDENTI PHARMS INC

* IDENTI PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
IMPAX LABS
* IMPAX LABORATORIES INC
ACARBOSE, ACARBOSE
ALPRAZOLAM, ALPRAZOLAM
ANAGRELIDE HYDROCHLORIDE,
BACLOFEN, BACLOFEN

B - 67

ANAGRELIDE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

B - 68

PRODUCT NAME SORTED BY APPLICANT

**

**

* IMPAX LABORATORIES INC

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE
DANTROLENE SODIUM, DANTROLENE SODIUM
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DIGOXIN, DIGOXIN
DIPYRIDAMOLE, DIPYRIDAMOLE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
LETROZOLE, LETROZOLE
LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)
LORATADINE, LORATADINE (OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHYLTESTOSTERONE, METHYLTESTOSTERONE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE
OMEPRAZOLE, OMEPRAZOLE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PENTOXIFYLLINE, PENTOXIFYLLINE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
RILUZOLE, RILUZOLE
RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

IMPAX LABS INC

* IMPAX LABORATORIES INC
CABERGOLINE, CABERGOLINE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

IMPAX PHARMS
* IMPAX PHARMACEUTICALS
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE,
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
GEMFIBROZIL, GEMFIBROZIL
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

INALCO
* INALCO SPA
LACTULOSE,

LACTULOSE

INCYTE CORP
* INCYTE CORP
JAKAFI, RUXOLITINIB PHOSPHATE
INDICUS PHARMA
* INDICUS PHARMA LLC
LETROZOLE, LETROZOLE

METFORMIN HYDROCHLORIDE,

METFORMIN HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

INNOPHARMA LLC
* INNOPHARMA LLC
LEVETIRACETAM, LEVETIRACETAM

OLANZAPINE, OLANZAPINE

INO
* INO THERAPEUTICS INC
INOMAX, NITRIC OXIDE
INSIGHT PHARMS
* INSIGHT PHARMACEUTICALS CORP
MONISTAT 1 COMBINATION PACK, MICONAZOLE
MONISTAT 3 COMBINATION PACK (PREFILLED),
MONISTAT 3 COMBINATION PACK, MICONAZOLE
MONISTAT 3, MICONAZOLE NITRATE
MONISTAT 3, MICONAZOLE NITRATE (OTC)
MONISTAT 7 COMBINATION PACK, MICONAZOLE
MONISTAT 7, MICONAZOLE NITRATE (OTC)
MONISTAT-3 COMBINATION PACK, MICONAZOLE
NIX, PERMETHRIN (OTC)

NITRATE (OTC)
MICONAZOLE NITRATE
NITRATE (OTC)

NITRATE

(OTC)

NITRATE

(OTC)

(OTC)

INSPIRE
* INSPIRE PHARMACEUTICALS INC
AZASITE, AZITHROMYCIN
INST BIOCHEM
* INSTITUT BIOCHEMIQUE SA
FLECTOR, DICLOFENAC EPOLAMINE
INST BIOCHIMIQUE
* INSTITUTE BIOCHIMIQUE SA (IBSA)
TIROSINT, LEVOTHYROXINE SODIUM
INSTITUT BIOCHIMIQUE
* INSTITUT BIOCHIMIQUE SA IBSA
TIROSINT, LEVOTHYROXINE SODIUM
INSTITUTO BIOCHEMICO
* INSTITUTO BIOCHEMICO ITALIANO SPA
AMPICILLIN SODIUM, AMPICILLIN SODIUM
NAFCILLIN SODIUM, NAFCILLIN SODIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

INSTITUTO BIOCHIMICO
* INSTITUTO BIOCHIMICO ITALIANO SPA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
INSYS THERAP
* INSYS THERAPEUTICS INC
DRONABINOL, DRONABINOL
INTELGENX CORP
* INTELGENX CORP
FORFIVO XL, BUPROPION HYDROCHLORIDE
INTENDIS
* INTENDIS INC
DESONATE, DESONIDE

FINACEA, AZELAIC ACID

INTERGEL PHARM
* INTERGEL PHARMACEUTICAL INC
NIFEDIPINE, NIFEDIPINE
INTL MEDICATED
* INTERNATIONAL MEDICATED SYSTEMS LTD
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

B - 69

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

INTL MEDICATION
* INTERNATIONAL MEDICATION SYSTEM
AMINOPHYLLINE, AMINOPHYLLINE
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE
FUROSEMIDE, FUROSEMIDE
ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE
LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
MANNITOL 25%, MANNITOL
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
PHYTONADIONE, PHYTONADIONE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

* INTERNATIONAL MEDICATION SYSTEMS LTD

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

INTL MEDICATION SYS

* INTERNATIONAL MEDICATION SYSTEMS LTD
LORAZEPAM, LORAZEPAM
INVAGEN PHARMS
* INVAGEN PHARMACEUTICALS INC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
FOLIC ACID, FOLIC ACID
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
GEMFIBROZIL, GEMFIBROZIL
GLIMEPIRIDE, GLIMEPIRIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
MEPROBAMATE, MEPROBAMATE
NABUMETONE, NABUMETONE
NAPROXEN, NAPROXEN
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TRANDOLAPRIL, TRANDOLAPRIL
WARFARIN SODIUM, WARFARIN SODIUM
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

INWOOD LABS
* INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC
THEOPHYLLINE, THEOPHYLLINE
IPCA LABS LTD
* IPCA LABORATORIES LTD
ALLOPURINOL, ALLOPURINOL
ATENOLOL, ATENOLOL
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
FUROSEMIDE, FUROSEMIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

B - 70

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* IPCA LABORATORIES LTD

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

IPR
* IPR PHARMACEUTICALS INC
ATENOLOL AND CHLORTHALIDONE, ATENOLOL
ATENOLOL, ATENOLOL
CRESTOR, ROSUVASTATIN CALCIUM

ZOMIG, ZOLMITRIPTAN

IPR PHARMS INC

* IPR PHARMACEUTICALS INC
VANDETANIB, VANDETANIB
IPSEN PHARMS
* IPSEN PHARMACEUTICALS INC
SOMATULINE DEPOT, LANREOTIDE ACETATE
IROKO PHARMS
* IROKO PHARMACEUTICALS LLC
INDOCIN, INDOMETHACIN
ISO TEX
* ISO TEX DIAGNOSTICS INC
JEANATOPE, ALBUMIN IODINATED I-125 SERUM

MEGATOPE, ALBUMIN IODINATED I-131 SERUM

ISTA PHARMS
* ISTA PHARMACEUTICALS
BEPREVE, BEPOTASTINE BESILATE
ISTALOL, TIMOLOL MALEATE

VITRASE, HYALURONIDASE

ISTA PHARMS INC

* ISTA PHARMACEUTICALS INC
BROMDAY, BROMFENAC SODIUM
ISTITUTO BIOCHIMICO
* ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI
PIPERACILLIN, PIPERACILLIN SODIUM
IVAX PHARMS
* IVAX PHARMACEUTICALS INC
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
IVAX SUB TEVA PHARMS
* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
BACLOFEN, BACLOFEN
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BUMETANIDE, BUMETANIDE
CABERGOLINE, CABERGOLINE
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
(OTC)
CIMETIDINE, CIMETIDINE

CIMETIDINE, CIMETIDINE (OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOZAPINE, CLOZAPINE

CYCLOSPORINE, CYCLOSPORINE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DIAZEPAM, DIAZEPAM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA

FENOPROFEN CALCIUM, FENOPROFEN CALCIUM
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUTAMIDE, FLUTAMIDE
FUROSEMIDE, FUROSEMIDE
GABAPENTIN, GABAPENTIN
GLIPIZIDE, GLIPIZIDE
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE
GUANABENZ ACETATE, GUANABENZ ACETATE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
INDAPAMIDE, INDAPAMIDE
INDOMETHACIN, INDOMETHACIN
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LORAZEPAM, LORAZEPAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHYLDOPA, METHYLDOPA
MISOPROSTOL, MISOPROSTOL
NADOLOL, NADOLOL
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
OXAPROZIN, OXAPROZIN
OXAZEPAM, OXAZEPAM
PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE
PROBENECID, PROBENECID
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
SIMVASTATIN, SIMVASTATIN
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

JACOBUS
* JACOBUS PHARMACEUTICAL CO
DAPSONE, DAPSONE

PASER, AMINOSALICYLIC ACID

JANSSEN BIOTECH
* JANSSEN BIOTECH INC
ZYTIGA, ABIRATERONE ACETATE
JANSSEN PHARMS
* JANSSEN PHARMACEUTICALS INC
AXERT, ALMOTRIPTAN MALATE
CONCERTA, METHYLPHENIDATE HYDROCHLORIDE
DITROPAN XL, OXYBUTYNIN CHLORIDE
DITROPAN, OXYBUTYNIN CHLORIDE
DORIBAX, DORIPENEM
DURAGESIC-100, FENTANYL
DURAGESIC-12, FENTANYL
DURAGESIC-25, FENTANYL
DURAGESIC-50, FENTANYL
DURAGESIC-75, FENTANYL
ELMIRON, PENTOSAN POLYSULFATE SODIUM
HALDOL, HALOPERIDOL DECANOATE
HALDOL, HALOPERIDOL LACTATE
INVEGA SUSTENNA, PALIPERIDONE PALMITATE
INVEGA, PALIPERIDONE
LEUSTATIN, CLADRIBINE
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER,
LEVAQUIN, LEVOFLOXACIN

MICRONOR, NORETHINDRONE

LEVOFLOXACIN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** J

**

* JANSSEN PHARMACEUTICALS INC

MODICON 28, ETHINYL ESTRADIOL
NIZORAL, KETOCONAZOLE
NUCYNTA ER, TAPENTADOL HYDROCHLORIDE
NUCYNTA, TAPENTADOL HYDROCHLORIDE
ORTHO CYCLEN-28, ETHINYL ESTRADIOL
ORTHO EVRA, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL
ORTHO-CEPT, DESOGESTREL
ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL
ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL
PANCREAZE, LIPASE
RAZADYNE ER, GALANTAMINE HYDROBROMIDE
RAZADYNE, GALANTAMINE HYDROBROMIDE
RISPERDAL CONSTA, RISPERIDONE
RISPERDAL, RISPERIDONE
SPORANOX, ITRACONAZOLE
TERAZOL 3, TERCONAZOLE
TERAZOL 7, TERCONAZOLE
TOPAMAX, TOPIRAMATE
TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN
TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN
TYLOX, ACETAMINOPHEN
ULTRACET, ACETAMINOPHEN
ULTRAM, TRAMADOL HYDROCHLORIDE

XARELTO, RIVAROXABAN

JANSSEN R AND D
* JANSSEN RESEARCH AND DEVELOPMENT LLC
FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE

PARAFON FORTE DSC, CHLORZOXAZONE

JAZZ
* JAZZ PHARMACEUTICALS
LUVOX CR, FLUVOXAMINE MALEATE

XYREM, SODIUM OXYBATE

JHP PHARMS
* JHP PHARMACEUTICALS LLC
BREVITAL SODIUM, METHOHEXITAL SODIUM
COLY-MYCIN M, COLISTIMETHATE SODIUM
COLY-MYCIN S, COLISTIN SULFATE
DANTRIUM, DANTROLENE SODIUM
DELESTROGEN, ESTRADIOL VALERATE
KETALAR, KETAMINE HYDROCHLORIDE
PITOCIN, OXYTOCIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIOSTAT, LIOTHYRONINE SODIUM

JIANGSU HENGRUI MED

* JIANGSU HENGRUI MEDICINE CO LTD
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
JOHN O BUTLER CO
* JOHN O BUTLER CO
CHLORHEXIDINE GLUCONATE,

CHLORHEXIDINE GLUCONATE

JOHNSON AND JOHNSON

* JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
MEN'S ROGAINE, MINOXIDIL (OTC)
ROGAINE (FOR MEN), MINOXIDIL (OTC)
ROGAINE (FOR WOMEN), MINOXIDIL (OTC)
ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)

VISINE-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

JUBILANT CADISTA
* JUBILANT CADISTA PHARMACEUTICALS INC
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
FOLIC ACID, FOLIC ACID
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
METHYLPREDNISOLONE, METHYLPREDNISOLONE
PREDNISONE, PREDNISONE
PROCOMP, PROCHLORPERAZINE MALEATE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

JUBILANT LIFE
* JUBILANT LIFE SCIENCES LTD
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

JUBILANT ORGANOSYS
* JUBILANT ORGANOSYS LTD
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

RISPERIDONE, RISPERIDONE

KEY PHARMS
* KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP
NITRO-DUR, NITROGLYCERIN
KIEL
* KIEL LABORATORIES INC
ORPHENADRINE CITRATE,

ORPHENADRINE CITRATE

KING PHARMS
* KING PHARMACEUTICALS INC
ALTACE, RAMIPRIL
AVINZA, MORPHINE SULFATE
BICILLIN C-R 900/300, PENICILLIN G BENZATHINE
BICILLIN C-R, PENICILLIN G BENZATHINE
BICILLIN L-A, PENICILLIN G BENZATHINE
CORGARD, NADOLOL
CORZIDE, BENDROFLUMETHIAZIDE
CYTOMEL, LIOTHYRONINE SODIUM
INTAL, CROMOLYN SODIUM
LEVOXYL, LEVOTHYROXINE SODIUM
PENICILLIN G PROCAINE, PENICILLIN G PROCAINE
SILVADENE, SILVER SULFADIAZINE
SKELAXIN, METAXALONE
SYNERCID, DALFOPRISTIN

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC
SONATA, ZALEPLON
TAPAZOLE, METHIMAZOLE

TUSSIGON, HOMATROPINE METHYLBROMIDE

KING PHARMS R AND D

* KING PHARMACEUTICALS RESEARCH DEVELOPMENT INC
OXECTA, OXYCODONE HYDROCHLORIDE
KOWA CO
* KOWA CO LTD
LIVALO, PITAVASTATIN CALCIUM
KREMERS URBAN PHARMS
* KREMERS URBAN PHARMACEUTICALS INC
GLYCOLAX, POLYETHYLENE GLYCOL 3350
GLYCOLAX, POLYETHYLENE GLYCOL 3350 (OTC)
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
NITROGLYCERIN, NITROGLYCERIN

OMEPRAZOLE, OMEPRAZOLE

B - 74

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

KUDCO IRELAND
* KUDCO IRELAND LTD
ANASTROZOLE, ANASTROZOLE
BICALUTAMIDE, BICALUTAMIDE
LETROZOLE, LETROZOLE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

KV PHARM
* KV PHARMACEUTICAL CO
CLINDESSE, CLINDAMYCIN PHOSPHATE
EVAMIST, ESTRADIOL
GYNAZOLE-1, BUTOCONAZOLE NITRATE

MAKENA, HYDROXYPROGESTERONE CAPROATE

KVK TECH
* KVK TECH INC
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
KALEXATE, SODIUM POLYSTYRENE SULFONATE
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

LAB HRA PHARMA

* LABORATOIRE HRA PHARMA
ELLA, ULIPRISTAL ACETATE
LANDELA PHARM
* LANDELA PHARMACEUTICAL
ALBUTEROL SULFATE, ALBUTEROL SULFATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LANNETT
* LANNETT CO INC
ACETAZOLAMIDE, ACETAZOLAMIDE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
LANORINAL, ASPIRIN
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE
PROBALAN, PROBENECID

SERPALAN, RESERPINE

* LANNETT HOLDINGS INC

BACLOFEN, BACLOFEN
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
DANAZOL, DANAZOL
DIPYRIDAMOLE, DIPYRIDAMOLE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
RIFAMPIN, RIFAMPIN
TERBUTALINE SULFATE, TERBUTALINE SULFATE

URSODIOL, URSODIOL

B - 75

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

LANNETT HOLDINGS INC

* LANNETT HOLDINGS INC
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
METHOCARBAMOL, METHOCARBAMOL
MORPHINE SULFATE, MORPHINE SULFATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PHENTERMINE RESIN COMPLEX, PHENTERMINE RESIN COMPLEX

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LANTHEUS MEDCL
* LANTHEUS MEDICAL IMAGING INC
ABLAVAR, GADOFOSVESET TRISODIUM
CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT
DEFINITY, PERFLUTREN
GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67
NEUROLITE, TECHNETIUM TC-99M BICISATE KIT
TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

XENON XE 133, XENON XE-133

LAVIPHARM LABS
* LAVIPHARM LABORATORIES INC
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

LEHIGH VALLEY
* LEHIGH VALLEY TECHNOLOGIES INC
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
LEK PHARMS
* LEK PHARMACEUTICALS D D
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
LISINOPRIL, LISINOPRIL

OMEPRAZOLE, OMEPRAZOLE

LEK PHARMS DD
* LEK PHARMACEUTICALS DD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

LEO PHARM
* LEO PHARMACEUTICAL PRODUCTS LTD
DOVONEX, CALCIPOTRIENE

TACLONEX, BETAMETHASONE DIPROPIONATE

LEO PHARM PRODS

* LEO PHARMACEUTICAL PRODUCTS LTD
TACLONEX SCALP, BETAMETHASONE DIPROPIONATE
LEO PHARMA AS
* LEO PHARMA AS
INNOHEP, TINZAPARIN SODIUM
LG LIFE
* LG LIFE SCIENCES LTD
VALTROPIN, SOMATROPIN RECOMBINANT
LILLY
* ELI LILLY AND CO
ALIMTA, PEMETREXED DISODIUM
CIALIS, TADALAFIL
CYMBALTA, DULOXETINE HYDROCHLORIDE

EVISTA, RALOXIFENE HYDROCHLORIDE

B - 76

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** L

**

* ELI LILLY AND CO

FORTEO, TERIPARATIDE RECOMBINANT HUMAN
GEMZAR, GEMCITABINE HYDROCHLORIDE
GLUCAGON, GLUCAGON RECOMBINANT
HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT
HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 50/50 PEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25 PEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG PEN, INSULIN LISPRO RECOMBINANT
HUMALOG, INSULIN LISPRO RECOMBINANT
HUMATROPE, SOMATROPIN RECOMBINANT
HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN R, INSULIN RECOMBINANT HUMAN
HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC)
PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE
QUINIDINE GLUCONATE, QUINIDINE GLUCONATE
STRATTERA, ATOMOXETINE HYDROCHLORIDE
SYMBYAX, FLUOXETINE HYDROCHLORIDE
ZYPREXA ZYDIS, OLANZAPINE

ZYPREXA, OLANZAPINE

* LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO

PROZAC, FLUOXETINE HYDROCHLORIDE

SARAFEM, FLUOXETINE HYDROCHLORIDE

LLOYD
* LLOYD INC
LEVOTHROID,

LEVOTHYROXINE SODIUM

LNK
* LNK INTERNATIONAL INC
DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)
IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

LOREAL USA
* LOREAL USA PRODUCTS INC
ANTHELIOS 20, AVOBENZONE (OTC)
ANTHELIOS 40, AVOBENZONE (OTC)
ANTHELIOS SX, AVOBENZONE (OTC)

CAPITAL SOLEIL 15, AVOBENZONE (OTC)

LUITPOLD
* LUITPOLD PHARMACEUTICALS INC
ACETYLCYSTEINE, ACETYLCYSTEINE
ADENOSINE, ADENOSINE
AMINOCAPROIC ACID, AMINOCAPROIC ACID
AMINOPHYLLINE, AMINOPHYLLINE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CAFFEINE CITRATE, CAFFEINE CITRATE
CALCITRIOL, CALCITRIOL
CEFTRIAXONE, CEFTRIAXONE SODIUM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CYANOCOBALAMIN, CYANOCOBALAMIN
CYCLOSPORINE, CYCLOSPORINE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DEXFERRUM, IRON DEXTRAN
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

B - 77

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* LUITPOLD PHARMACEUTICALS INC

DROPERIDOL, DROPERIDOL
ESTRADIOL VALERATE, ESTRADIOL VALERATE
ETOMIDATE, ETOMIDATE
FOMEPIZOLE, FOMEPIZOLE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FUROSEMIDE, FUROSEMIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
IBUTILIDE FUMARATE, IBUTILIDE FUMARATE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LATANOPROST, LATANOPROST
LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM
LEVOCARNITINE, LEVOCARNITINE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
MANNITOL 25%, MANNITOL
METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
NITROGLYCERIN, NITROGLYCERIN
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PROGESTERONE, PROGESTERONE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
SPRIX, KETOROLAC TROMETHAMINE
TORSEMIDE, TORSEMIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
VENOFER, IRON SUCROSE

ZIDOVUDINE, ZIDOVUDINE

LUNDBECK INC
* LUNDBECK INC
CHEMET, SUCCIMER
COGENTIN, BENZTROPINE MESYLATE
COSMEGEN, DACTINOMYCIN
DESOXYN, METHAMPHETAMINE HYDROCHLORIDE
DIURIL, CHLOROTHIAZIDE SODIUM
INDOCIN, INDOMETHACIN SODIUM
MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE
NEMBUTAL SODIUM, PENTOBARBITAL SODIUM
NEOPROFEN, IBUPROFEN LYSINE
ONFI, CLOBAZAM
PEGANONE, ETHOTOIN
SABRIL, VIGABATRIN

TRANXENE, CLORAZEPATE DIPOTASSIUM

LUPIN
* LUPIN LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFPROZIL, CEFPROZIL
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN

DIVALPROEX SODIUM, DIVALPROEX SODIUM

B - 78

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* LUPIN LTD
ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOVASTATIN, LOVASTATIN
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN

TRANDOLAPRIL, TRANDOLAPRIL

LUPIN ATLANTIS
* LUPIN ATLANTIS HOLDINGS SA
ANTARA (MICRONIZED), FENOFIBRATE
LUPIN LTD
* LUPIN LIMITED
LEVETIRACETAM, LEVETIRACETAM

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

* LUPIN LTD
FAMOTIDINE, FAMOTIDINE
FENOFIBRATE, FENOFIBRATE
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEFENAMIC ACID, MEFENAMIC ACID
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NABUMETONE, NABUMETONE
NORETHINDRONE, NORETHINDRONE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
SUPRAX, CEFIXIME

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

LUPIN PHARMS
* LUPIN PHARMACEUTICALS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE,
DESLORATADINE, DESLORATADINE
MELOXICAM, MELOXICAM
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

SUPRAX, CEFIXIME

AMLODIPINE BESYLATE

LYNE
* LYNE LABORATORIES INC
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DEXAMETHASONE, DEXAMETHASONE
HYDROCORTISONE, HYDROCORTISONE
LEVOCARNITINE, LEVOCARNITINE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

LYNROSE LABS
* LYNROSE LABS LLC
CARBINOXAMINE MALEATE,

CARBINOXAMINE MALEATE

MALLINCKRODT
* MALLINCKRODT CHEMICAL INC
ANEXSIA 7.5/650, ACETAMINOPHEN
ANEXSIA, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHADOSE, METHADONE HYDROCHLORIDE

B - 79

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M

**

* MALLINCKRODT CHEMICAL INC

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
* MALLINCKRODT INC
ANEXSIA 5/325, ACETAMINOPHEN
ANEXSIA 7.5/325, ACETAMINOPHEN
ANEXSIA, ACETAMINOPHEN
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
FENTANYL CITRATE, FENTANYL CITRATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE
METHYLIN, METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE
OPTIMARK, GADOVERSETAMIDE
OXYCET, ACETAMINOPHEN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PENNSAID, DICLOFENAC SODIUM
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
TECHNETIUM TC-99 SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

* MALLINCKRODT MEDICAL INC

CONRAY 30, IOTHALAMATE MEGLUMINE
CONRAY 43, IOTHALAMATE MEGLUMINE
CONRAY, IOTHALAMATE MEGLUMINE
CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE
GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67
INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE
MD-76R, DIATRIZOATE MEGLUMINE
MD-GASTROVIEW, DIATRIZOATE MEGLUMINE
OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT
OPTIRAY 240, IOVERSOL
OPTIRAY 300, IOVERSOL
OPTIRAY 320, IOVERSOL
OPTIRAY 350, IOVERSOL
SODIUM IODIDE I 123, SODIUM IODIDE I-123
SODIUM IODIDE I 131, SODIUM IODIDE I-131
TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT
TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT
TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT

ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

MALLINCKRODT INC
* MALLINCKRODT INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
EXALGO, HYDROMORPHONE HYDROCHLORIDE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
RESTORIL, TEMAZEPAM

TOFRANIL, IMIPRAMINE HYDROCHLORIDE

B - 80

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MALLINCKRODT INC
TOFRANIL-PM, IMIPRAMINE PAMOATE
MALLINCKRODT LLC
* MALLINCKRODT LLC
ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE

PAMELOR, NORTRIPTYLINE HYDROCHLORIDE

MARATHON PHARMS
* MARATHON PHARMACEUTICALS LLC
SECONAL SODIUM, SECOBARBITAL SODIUM
MARKSANS PHARMA
* MARKSANS PHARMA LTD
GABAPENTIN, GABAPENTIN
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM
NAPROXEN, NAPROXEN

(OTC)

MARSAM PHARMS LLC

* MARSAM PHARMACEUTICALS LLC
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
MATRIX LABS LTD
* MATRIX LABORATORIES LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
BACLOFEN, BACLOFEN
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
DIDANOSINE, DIDANOSINE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
LANSOPRAZOLE, LANSOPRAZOLE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NABUMETONE, NABUMETONE
NIFEDIPINE, NIFEDIPINE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
RAMIPRIL, RAMIPRIL
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
STAVUDINE, STAVUDINE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VORICONAZOLE, VORICONAZOLE

ZIDOVUDINE, ZIDOVUDINE

MAYNE PHARMA
* MAYNE PHARMA INTERNATIONAL PTY LTD
DORYX, DOXYCYCLINE HYCLATE
MCNEIL
* MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
CHILDREN'S MOTRIN, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN (OTC)
IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE
MOTRIN IB, IBUPROFEN (OTC)
MOTRIN MIGRAINE PAIN, IBUPROFEN (OTC)

ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)

(OTC)

MCNEIL CONS
* MCNEIL CONSUMER HEALTHCARE
BENADRYL PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE
BENADRYL, DIPHENHYDRAMINE HYDROCHLORIDE
CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC)
CHILDREN'S MOTRIN, IBUPROFEN (OTC)
IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)

IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)

B - 81

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

* MCNEIL CONSUMER HEALTHCARE

IMODIUM, LOPERAMIDE HYDROCHLORIDE
JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC)
NIZORAL A-D, KETOCONAZOLE (OTC)
SINE-AID IB, IBUPROFEN (OTC)
SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE
SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE
TYLENOL (CAPLET), ACETAMINOPHEN (OTC)

TYLENOL (GELTAB), ACETAMINOPHEN (OTC)

**

(OTC)
(OTC)

MCNEIL CONSUMER
* MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

ZYRTEC, CETIRIZINE HYDROCHLORIDE

MEAD JOHNSON
* MEAD JOHNSON AND CO
CAFCIT, CAFFEINE CITRATE
MEDA PHARMS
* MEDA PHARMACEUTICALS
EDLUAR, ZOLPIDEM TARTRATE
* MEDA PHARMACEUTICALS INC
ANADROL-50, OXYMETHOLONE
ASTELIN, AZELASTINE HYDROCHLORIDE
ASTEPRO, AZELASTINE HYDROCHLORIDE
BUTISOL SODIUM, BUTABARBITAL SODIUM
CESAMET, NABILONE
COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
COLYTE, POLYETHYLENE GLYCOL 3350
COLYTE-FLAVORED, POLYETHYLENE GLYCOL 3350
CORTIFOAM, HYDROCORTISONE ACETATE
DEMADEX, TORSEMIDE
DEPEN, PENICILLAMINE
DIPENTUM, OLSALAZINE SODIUM
EPIFOAM, HYDROCORTISONE ACETATE
FELBATOL, FELBAMATE
LUFYLLIN, DYPHYLLINE
MUSE, ALPROSTADIL
ONSOLIS, FENTANYL CITRATE
OPTIVAR, AZELASTINE HYDROCHLORIDE
PROCTOFOAM HC, HYDROCORTISONE ACETATE
ROWASA, MESALAMINE
SFROWASA, MESALAMINE

TRILYTE, POLYETHYLENE GLYCOL 3350

* MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC

SOMA COMPOUND W/ CODEINE, ASPIRIN
SOMA COMPOUND, ASPIRIN

SOMA, CARISOPRODOL

MEDICINES CO
* THE MEDICINES CO
ANGIOMAX, BIVALIRUDIN

CLEVIPREX, CLEVIDIPINE BUTYRATE

MEDICIS
* MEDICIS PHARMACEUTICAL CORP
ALDARA, IMIQUIMOD
BUPHENYL, SODIUM PHENYLBUTYRATE
CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DYNACIN, MINOCYCLINE HYDROCHLORIDE
ESTRASORB, ESTRADIOL HEMIHYDRATE

LIDEX, FLUOCINONIDE

B - 82

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M

* MEDICIS PHARMACEUTICAL CORP

LIDEX-E, FLUOCINONIDE
LOPROX, CICLOPIROX
MAXAIR, PIRBUTEROL ACETATE
METROGEL-VAGINAL, METRONIDAZOLE
NORFLEX, ORPHENADRINE CITRATE
NORGESIC FORTE, ASPIRIN
NORGESIC, ASPIRIN
SOLODYN, MINOCYCLINE HYDROCHLORIDE
SYNACORT, HYDROCORTISONE
TAMBOCOR, FLECAINIDE ACETATE
VANOS, FLUOCINONIDE
ZIANA, CLINDAMYCIN PHOSPHATE

ZYCLARA, IMIQUIMOD

MEDICURE
* MEDICURE INTERNATIONAL INC
AGGRASTAT, TIROFIBAN HYDROCHLORIDE
MEDIGENE AG
* MEDIGENE AG
VEREGEN, SINECATECHINS
MEDIMETRIKS PHARMS
* MEDIMETRIKS PHARMACEUTICALS INC
SYNALAR, FLUOCINOLONE ACETONIDE
MEDIMMUNE
* MEDIMMUNE
ETHYOL,

AMIFOSTINE

MEDTRONIC
* MEDTRONIC INC
LIORESAL, BACLOFEN
MERCK
* MERCK AND CO INC
AMINOHIPPURATE SODIUM, AMINOHIPPURATE SODIUM
CANCIDAS, CASPOFUNGIN ACETATE
EMEND, APREPITANT
FOSAMAX PLUS D, ALENDRONATE SODIUM
FOSAMAX, ALENDRONATE SODIUM
HYZAAR, HYDROCHLOROTHIAZIDE
INVANZ, ERTAPENEM SODIUM
JANUMET, METFORMIN HYDROCHLORIDE
MAXALT, RIZATRIPTAN BENZOATE
MAXALT-MLT, RIZATRIPTAN BENZOATE
PRIMAXIN, CILASTATIN SODIUM
PROSCAR, FINASTERIDE
SINGULAIR, MONTELUKAST SODIUM
STROMECTOL, IVERMECTIN

ZOLINZA, VORINOSTAT

* MERCK RESEARCH LABORATORIES DIV MERCK CO INC

CLINORIL, SULINDAC
COSOPT, DORZOLAMIDE HYDROCHLORIDE
COZAAR, LOSARTAN POTASSIUM
MEVACOR, LOVASTATIN
NOROXIN, NORFLOXACIN
PEPCID, FAMOTIDINE
PRINIVIL, LISINOPRIL
PRINZIDE, HYDROCHLOROTHIAZIDE
PROPECIA, FINASTERIDE
SINGULAIR, MONTELUKAST SODIUM
TRUSOPT, DORZOLAMIDE HYDROCHLORIDE

ZOCOR, SIMVASTATIN

**

B - 83

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

MERCK AND CO INC

* MERCK AND CO INC
EMEND, FOSAPREPITANT DIMEGLUMINE

FOSAMAX, ALENDRONATE SODIUM

MERCK CO INC
* MERCK CO INC
JANUVIA, SITAGLIPTIN PHOSPHATE
MERCK KGAA
* MERCK KGAA
LEVOTHYROXINE SODIUM,

LEVOTHYROXINE SODIUM

MERCK SANTE SAS

* MERCK SANTE SAS
CYANOKIT, HYDROXOCOBALAMIN
MERCK SHARP DOHME
* MERCK SHARP AND DOHME CORP
CRIXIVAN, INDINAVIR SULFATE
ISENTRESS, RALTEGRAVIR POTASSIUM
JUVISYNC, SIMVASTATIN
PEPCID AC (GELTAB), FAMOTIDINE (OTC)
PEPCID AC, FAMOTIDINE (OTC)
PEPCID COMPLETE, CALCIUM CARBONATE (OTC)
SINEMET CR, CARBIDOPA

SINEMET, CARBIDOPA

MERIDIAN MEDCL
* MERIDIAN MEDICAL TECHNOLOGIES INC
DUODOTE, ATROPINE
* MERIDIAN MEDICAL TECHNOLOGIES INC SUB KING PHARMACEUTICALS INC
ALSUMA, SUMATRIPTAN SUCCINATE
MERIDIAN MEDCL TECHN
* MERIDIAN MEDICAL TECHNOLOGIES INC
ATROPEN, ATROPINE
EPIPEN JR., EPINEPHRINE
EPIPEN, EPINEPHRINE
LIDOPEN, LIDOCAINE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE

PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE

MERRO PHARM
* MERRO PHARMACEUTICAL CO LTD
IBUPROFEN, IBUPROFEN (OTC)
MERZ PHARMS
* MERZ PHARMACEUTICALS LLC
ERYGEL, ERYTHROMYCIN

NAFTIN, NAFTIFINE HYDROCHLORIDE

METHAPHARM
* METHAPHARM INC
LEVETIRACETAM, LEVETIRACETAM

PROVOCHOLINE, METHACHOLINE CHLORIDE

MICRO LABS LTD

* MICRO LABS LTD
MEFENAMIC ACID, MEFENAMIC ACID

SIMVASTATIN, SIMVASTATIN

MIKAH PHARMA
* MIKAH PHARMA LLC
ISRADIPINE, ISRADIPINE
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE

MIKART
* MIKART INC
ACETAMINOPHEN AND CODEINE PHOSPHATE,

ACETAMINOPHEN

B - 84

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** M

**

* MIKART INC
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMINOCAPROIC ACID, AMINOCAPROIC ACID
AMINOCAPROIC, AMINOCAPROIC ACID
BENZONATATE, BENZONATATE
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
BUTAPAP, ACETAMINOPHEN
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CHLORZOXAZONE, CHLORZOXAZONE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE
ESGIC-PLUS, ACETAMINOPHEN
ETHOSUXIMIDE, ETHOSUXIMIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
ISONIAZID, ISONIAZID
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METHAZOLAMIDE, METHAZOLAMIDE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PYRAZINAMIDE, PYRAZINAMIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

MILLENNIUM PHARMS
* MILLENNIUM PHARMACEUTICALS INC
VELCADE, BORTEZOMIB
MIRROR PHARMS
* MIRROR PHARMACEUTICALS LLC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CARISOPRODOL AND ASPIRIN, ASPIRIN
CARISOPRODOL, CARISOPRODOL
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN

PROBENECID AND COLCHICINE, COLCHICINE

MISSION PHARMA
* MISSION PHARMACAL CO
LITHOSTAT, ACETOHYDROXAMIC ACID
TEXACORT, HYDROCORTISONE
TINDAMAX, TINIDAZOLE
TIOPRONIN, TIOPRONIN

UROCIT-K, POTASSIUM CITRATE

MN PHARMS
* MN PHARMACEUTICALS
PAMIDRONATE DISODIUM,

PAMIDRONATE DISODIUM

MOLNLYCKE HLTH
* MOLNLYCKE HEALTH CARE
HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)

HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)

MONARCH PHARMS
* MONARCH PHARMACEUTICALS INC
CORTISPORIN, BACITRACIN ZINC
CORTISPORIN, HYDROCORTISONE
CORTISPORIN, HYDROCORTISONE ACETATE
MENEST, ESTROGENS, ESTERIFIED
NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE
NEOSPORIN, GRAMICIDIN
PEDIOTIC, HYDROCORTISONE
SEPTRA DS, SULFAMETHOXAZOLE
SEPTRA, SULFAMETHOXAZOLE
THALITONE, CHLORTHALIDONE

VIROPTIC, TRIFLURIDINE

B - 85

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

MONOSOL RX LLC
* MONOSOL RX LLC
ZUPLENZ, ONDANSETRON
MORTON GROVE
* MORTON GROVE PHARMACEUTICALS INC
LACTULOSE, LACTULOSE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

MORTON GROVE PHARMS

* MORTON GROVE PHARMACEUTICALS INC
GENERLAC, LACTULOSE
MSD CONSUMER
* MSD CONSUMER CARE INC
ZEGERID OTC, OMEPRAZOLE

(OTC)

MSD INTL
* MSD INTERNATIONAL GMBH
VYTORIN, EZETIMIBE
MSP SINGAPORE
* MSP SINGAPORE CO LLC
ZETIA, EZETIMIBE
MURTY PHARMS
* MURTY PHARMACEUTICALS INC
DIPYRIDAMOLE, DIPYRIDAMOLE
MUSTAFA NEVSAT
* MUSTAFA NEVSAT ILAC SANAYII AS
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
MUSTAFA NEVZAT
* MUSTAFA NEVZAT ILAC SANAYII AS
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

VECURONIUM BROMIDE, VECURONIUM BROMIDE

MUTUAL PHARM
* MUTUAL PHARMACEUTICAL CO INC
ACETAZOLAMIDE, ACETAZOLAMIDE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALLOPURINOL, ALLOPURINOL
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
ATENOLOL AND CHLORTHALIDONE, ATENOLOL
ATENOLOL, ATENOLOL
BACTRIM DS, SULFAMETHOXAZOLE
BACTRIM, SULFAMETHOXAZOLE
CARISOPRODOL, CARISOPRODOL
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
ERGOLOID MESYLATES, ERGOLOID MESYLATES
FELODIPINE, FELODIPINE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
LOVASTATIN, LOVASTATIN
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE, METRONIDAZOLE
MINOXIDIL, MINOXIDIL
NYSTATIN, NYSTATIN
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PIROXICAM, PIROXICAM
PREDNISONE, PREDNISONE
PRIMIDONE, PRIMIDONE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

B - 86

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MUTUAL PHARMACEUTICAL CO INC

QUINIDINE SULFATE, QUINIDINE SULFATE
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
SPIRONOLACTONE, SPIRONOLACTONE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
SULINDAC, SULINDAC
TEMAZEPAM, TEMAZEPAM
THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE
TOLMETIN SODIUM, TOLMETIN SODIUM
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

MUTUAL PHARM CO INC

* MUTUAL PHARMACEUTICAL CO INC
LEVETIRACETAM, LEVETIRACETAM
MUTUAL PHARMA
* MUTUAL PHARMACAL CO
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
KETOCONAZOLE, KETOCONAZOLE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

MYLAN
* MYLAN LABORATORIES INC
ACYCLOVIR, ACYCLOVIR
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
CAPTOPRIL, CAPTOPRIL
ETODOLAC, ETODOLAC

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

* MYLAN PHARMACEUTICALS
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
* MYLAN PHARMACEUTICALS INC
ACARBOSE, ACARBOSE
ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE
ACYCLOVIR, ACYCLOVIR
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALLOPURINOL, ALLOPURINOL
ALPRAZOLAM, ALPRAZOLAM
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMNESTEEM, ISOTRETINOIN
ANASTROZOLE, ANASTROZOLE
ATENOLOL AND CHLORTHALIDONE, ATENOLOL
ATENOLOL, ATENOLOL
ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE
AVITA, TRETINOIN
AZATHIOPRINE, AZATHIOPRINE
AZITHROMYCIN, AZITHROMYCIN
BACLOFEN, BACLOFEN
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BICALUTAMIDE, BICALUTAMIDE
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
BUDESONIDE, BUDESONIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

B - 87

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MYLAN PHARMACEUTICALS INC

CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL
CARBIDOPA AND LEVODOPA, CARBIDOPA
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
CHLOROTHIAZIDE, CHLOROTHIAZIDE
CHLORPROPAMIDE, CHLORPROPAMIDE
CHLORTHALIDONE, CHLORTHALIDONE
CILOSTAZOL, CILOSTAZOL
CIMETIDINE, CIMETIDINE
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
CLORPRES, CHLORTHALIDONE
CLOZAPINE, CLOZAPINE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
CYSTAGON, CYSTEAMINE BITARTRATE
DIAZEPAM, DIAZEPAM
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
ESTRADIOL, ESTRADIOL
ESTROPIPATE, ESTROPIPATE
ETIDRONATE DISODIUM, ETIDRONATE DISODIUM
ETOPOSIDE, ETOPOSIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
FELODIPINE, FELODIPINE
FENOFIBRATE, FENOFIBRATE
FENOPROFEN CALCIUM, FENOPROFEN CALCIUM
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
FLURBIPROFEN, FLURBIPROFEN
FLUTAMIDE, FLUTAMIDE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FUROSEMIDE, FUROSEMIDE
GABAPENTIN, GABAPENTIN

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

B - 88

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* MYLAN PHARMACEUTICALS INC

GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLIPIZIDE, GLIPIZIDE
GLYBURIDE (MICRONIZED), GLYBURIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
INDAPAMIDE, INDAPAMIDE
INDOMETHACIN, INDOMETHACIN
KETOCONAZOLE, KETOCONAZOLE
KETOPROFEN, KETOPROFEN
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LAMOTRIGINE, LAMOTRIGINE
LATANOPROST, LATANOPROST
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE
LORATADINE, LORATADINE (OTC)
LORAZEPAM, LORAZEPAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOVASTATIN, LOVASTATIN
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE
MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM
MELOXICAM, MELOXICAM
MENTAX, BUTENAFINE HYDROCHLORIDE
MENTAX-TC, BUTENAFINE HYDROCHLORIDE
MERCAPTOPURINE, MERCAPTOPURINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHIMAZOLE, METHIMAZOLE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METHYCLOTHIAZIDE, METHYCLOTHIAZIDE
METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METHYLDOPA, METHYLDOPA
METOLAZONE, METOLAZONE
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NADOLOL AND BENDROFLUMETHAZIDE, BENDROFLUMETHIAZIDE
NADOLOL, NADOLOL
NAPROXEN, NAPROXEN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NIFEDIPINE, NIFEDIPINE
NISOLDIPINE, NISOLDIPINE
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN
NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
NIZATIDINE, NIZATIDINE
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

B - 89

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APPENDIX B

B - 90

PRODUCT NAME SORTED BY APPLICANT

**

**

* MYLAN PHARMACEUTICALS INC

OXAPROZIN, OXAPROZIN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PACLITAXEL, PACLITAXEL
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL 3350
PENTOXIFYLLINE, PENTOXIFYLLINE
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
PHENYTEK, PHENYTOIN SODIUM
PINDOLOL, PINDOLOL
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIROXICAM, PIROXICAM
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE
PROBENECID, PROBENECID
PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
SPIRONOLACTONE, SPIRONOLACTONE
STAVUDINE, STAVUDINE
SULINDAC, SULINDAC
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TACROLIMUS, TACROLIMUS
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TEMAZEPAM, TEMAZEPAM
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE
THIOTHIXENE, THIOTHIXENE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIMOLOL MALEATE, TIMOLOL MALEATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOLAZAMIDE, TOLAZAMIDE
TOLBUTAMIDE, TOLBUTAMIDE
TOLMETIN SODIUM, TOLMETIN SODIUM
TOPIRAMATE, TOPIRAMATE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRANDOLAPRIL, TRANDOLAPRIL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE
URSODIOL, URSODIOL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM
ZALEPLON, ZALEPLON
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

MYLAN BERTEK
* MYLAN BERTEK PHARMACEUTICALS INC
AVITA, TRETINOIN
MAXZIDE, HYDROCHLOROTHIAZIDE

MAXZIDE-25, HYDROCHLOROTHIAZIDE

MYLAN INSTITUTIONAL
* MYLAN INSTITUTIONAL LLC
ALOPRIM, ALLOPURINOL SODIUM
DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE
DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
ENLON-PLUS, ATROPINE SULFATE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
TRANEXAMIC ACID, TRANEXAMIC ACID

ULTIVA, REMIFENTANIL HYDROCHLORIDE

MYLAN PHARMS INC

* MYLAN PHARMACEUTICALS INC
EPROSARTAN MESYLATE, EPROSARTAN MESYLATE
FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LEVETIRACETAM, LEVETIRACETAM
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MORPHINE SULFATE, MORPHINE SULFATE

MYLAN TECHNOLOGIES
* MYLAN TECHNOLOGIES INC
CLONIDINE, CLONIDINE
ESTRADIOL, ESTRADIOL
FENTANYL-100, FENTANYL
FENTANYL-12, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL

NITROGLYCERIN, NITROGLYCERIN

NATCO PHARMA
* NATCO PHARMA LTD
GRANISETRON HYDROCHLORIDE,

GRANISETRON HYDROCHLORIDE

NATCO PHARMA LTD

* NATCO PHARMA LIMITED
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
* NATCO PHARMA LTD
ANASTROZOLE, ANASTROZOLE
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
LETROZOLE, LETROZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

NAUTILUS NEUROSCIENC
* NAUTILUS NEUROSCIENCES INC
CAMBIA, DICLOFENAC POTASSIUM
NAVINTA LLC
* NAVINTA LLC
FAMOTIDINE, FAMOTIDINE
FOMEPIZOLE, FOMEPIZOLE

NICARDIPINE HYDROCHLORIDE,

NICARDIPINE HYDROCHLORIDE

NEPHRON
* NEPHRON CORP
ALBUTEROL SULFATE, ALBUTEROL SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

* NEPHRON PHARMACEUTICALS CORP

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE,
ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALBUTEROL SULFATE

B - 91

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

NESHER PHARMS
* NESHER PHARMACEUTICALS USA LLC
BENZONATATE, BENZONATATE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MICRO-K 10, POTASSIUM CHLORIDE
MICRO-K, POTASSIUM CHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
NYSTATIN, NYSTATIN
ONDANSETRON, ONDANSETRON
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE, PREDNISOLONE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

NEUROGESX
* NEUROGESX INC
QUTENZA, CAPSAICIN
NEW RIVER
* NEW RIVER PHARMACEUTICALS INC
PROFERDEX, IRON DEXTRAN
NEXGEN PHARMA
* NEXGEN PHARMA INC
BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CHENODIOL, CHENODIOL

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

NEXGEN PHARMA INC

* NEXGEN PHARMA INC
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

NEXUS PHARMS
* NEXUS PHARMACEUTICALS INC
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

NIAGARA PHARMS
* NIAGARA PHARMACEUTICALS INC
PUR-WASH, PURIFIED WATER

(OTC)

NORTHSTAR HLTHCARE
* NORTHSTAR HEALTHCARE HOLDINGS LTD
ALLOPURINOL, ALLOPURINOL
ATENOLOL, ATENOLOL
BACLOFEN, BACLOFEN
GEMFIBROZIL, GEMFIBROZIL
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
IBUPROFEN, IBUPROFEN
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

B - 92

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

NOSTRUM
* NOSTRUM PHARMACEUTICALS INC
CARBAMAZEPINE, CARBAMAZEPINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

NOSTRUM LABS
* NOSTRUM LABORATORIES INC
PIROXICAM, PIROXICAM

SUCRALFATE, SUCRALFATE

NOVADEL
* NOVADEL PHARMA INC
NITROMIST, NITROGLYCERIN

ZOLPIMIST, ZOLPIDEM TARTRATE

NOVARTIS
* NOVARTIS CONSUMER HEALTH INC
EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC)
HABITROL, NICOTINE (OTC)
LAMISIL AT, TERBINAFINE (OTC)
LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC)
LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC)
NEXCEDE, KETOPROFEN (OTC)
PREVACID 24 HR, LANSOPRAZOLE (OTC)
TAVIST ALLERGY/SINUS/HEADACHE, ACETAMINOPHEN
THRIVE, NICOTINE POLACRILEX (OTC)
TRANSDERM SCOP, SCOPOLAMINE
VAGISTAT-1, TIOCONAZOLE (OTC)

VOLTAREN, DICLOFENAC SODIUM

* NOVARTIS PHARMACEUTICALS CORP

AFINITOR, EVEROLIMUS
AMTURNIDE, ALISKIREN HEMIFUMARATE
ARCAPTA NEOHALER, INDACATEROL MALEATE
AREDIA, PAMIDRONATE DISODIUM
CATAFLAM, DICLOFENAC POTASSIUM
CLOZARIL, CLOZAPINE
COARTEM, ARTEMETHER
COMBIPATCH, ESTRADIOL
DESFERAL, DEFEROXAMINE MESYLATE
DIOVAN HCT, HYDROCHLOROTHIAZIDE
DIOVAN, VALSARTAN
ESTRADERM, ESTRADIOL
EXELON, RIVASTIGMINE
EXELON, RIVASTIGMINE TARTRATE
EXFORGE HCT, AMLODIPINE BESYLATE
EXFORGE, AMLODIPINE BESYLATE
EXJADE, DEFERASIROX
FAMVIR, FAMCICLOVIR
FANAPT, ILOPERIDONE
FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE
FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE
FORADIL, FORMOTEROL FUMARATE
GILENYA, FINGOLIMOD
GLEEVEC, IMATINIB MESYLATE
HYDERGINE, ERGOLOID MESYLATES
LAMISIL, TERBINAFINE HYDROCHLORIDE
LAMPRENE, CLOFAZIMINE
LESCOL XL, FLUVASTATIN SODIUM
LESCOL, FLUVASTATIN SODIUM
LOPRESSOR HCT, HYDROCHLOROTHIAZIDE
LOPRESSOR, METOPROLOL TARTRATE
LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE
LOTENSIN, BENAZEPRIL HYDROCHLORIDE

LOTREL, AMLODIPINE BESYLATE

(OTC)

B - 93

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APPENDIX B

B - 94

PRODUCT NAME SORTED BY APPLICANT

**

**

* NOVARTIS PHARMACEUTICALS CORP

METHERGINE, METHYLERGONOVINE MALEATE
METOPIRONE, METYRAPONE
MIACALCIN, CALCITONIN SALMON
MYFORTIC, MYCOPHENOLIC ACID
NEORAL, CYCLOSPORINE
OCUPRESS, CARTEOLOL HYDROCHLORIDE
PARLODEL, BROMOCRIPTINE MESYLATE
RECLAST, ZOLEDRONIC ACID
REGITINE, PHENTOLAMINE MESYLATE
RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE
RITALIN, METHYLPHENIDATE HYDROCHLORIDE
RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE
SANDIMMUNE, CYCLOSPORINE
SANDOSTATIN LAR, OCTREOTIDE ACETATE
SANDOSTATIN, OCTREOTIDE ACETATE
STARLIX, NATEGLINIDE
TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE
TAVIST-1, CLEMASTINE FUMARATE (OTC)
TEGRETOL, CARBAMAZEPINE
TEGRETOL-XR, CARBAMAZEPINE
TEKAMLO, ALISKIREN HEMIFUMARATE
TEKTURNA HCT, ALISKIREN HEMIFUMARATE
TEKTURNA, ALISKIREN HEMIFUMARATE
TRILEPTAL, OXCARBAZEPINE
TYZEKA, TELBIVUDINE
VALTURNA, ALISKIREN HEMIFUMARATE
VASOCIDIN, PREDNISOLONE SODIUM PHOSPHATE
VIVELLE, ESTRADIOL
VIVELLE-DOT, ESTRADIOL
VOLTAREN, DICLOFENAC SODIUM
VOLTAREN-XR, DICLOFENAC SODIUM
ZOMETA, ZOLEDRONIC ACID

ZORTRESS, EVEROLIMUS

NOVARTIS PHARMS
* NOVARTIS PHARMACEUTICALS CORP
FEMARA, LETROZOLE

TOBI, TOBRAMYCIN

NOVAST LABS LTD

* NOVAST LABORATORIES LTD
DASETTA 1/35, ETHINYL ESTRADIOL
DASETTA 7/7/7, ETHINYL ESTRADIOL
LEVONEST, ETHINYL ESTRADIOL

PHILITH, ETHINYL ESTRADIOL

NOVEL LABS INC

* NOVEL LABORATORIES INC
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE, SODIUM PHOSPHATE, DIBASIC,
ANHYDROUS
PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL 3350
PHENELZINE SULFATE, PHENELZINE SULFATE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
SULFAMETHOPRIM, SULFAMETHOXAZOLE
SULFAMETHOPRIM-DS, SULFAMETHOXAZOLE
TEMAZEPAM, TEMAZEPAM
TRIMETHOPRIM, TRIMETHOPRIM
NOVEN
* NOVEN PHARMACEUTICALS INC
FENTANYL-100, FENTANYL

FENTANYL-25, FENTANYL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

NOVEN PHARMACEUTICALS INC

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

NOVEN PHARMS INC

* NOVEN PHARMACEUTICALS INC
DAYTRANA, METHYLPHENIDATE
NOVEN THERAP
* NOVEN THERAPEUTICS LLC
LITHOBID, LITHIUM CARBONATE

PEXEVA, PAROXETINE MESYLATE

NOVEX
* NOVEX PHARMA
ALBUTEROL SULFATE, ALBUTEROL SULFATE
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE
CROMOLYN SODIUM, CROMOLYN SODIUM
CYCLOSPORINE, CYCLOSPORINE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LACTULOSE, LACTULOSE
LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
OFLOXACIN, OFLOXACIN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

TOBRAMYCIN, TOBRAMYCIN

NOVO NORDISK
* NOVO NORDISK PHARMACEUTICALS INC
GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT
NOVO NORDISK INC
* NOVO NORDISK INC
ACTIVELLA, ESTRADIOL
LEVEMIR, INSULIN DETEMIR RECOMBINANT
NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT
NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT
NORDITROPIN, SOMATROPIN RECOMBINANT
NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT
NOVOLOG, INSULIN ASPART RECOMBINANT
PRANDIMET, METFORMIN HYDROCHLORIDE
PRANDIN, REPAGLINIDE
VAGIFEM, ESTRADIOL

VICTOZA, LIRAGLUTIDE RECOMBINANT

NOVOCOL
* NOVOCOL PHARMACEUTICAL INC
ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN, LEVONORDEFRIN

ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE

NOVOCOL INC
* NOVOCOL INC
LIDOCAINE,

LIDOCAINE

NU PHARM
* NU PHARM INC
DIVALPROEX SODIUM,

DIVALPROEX SODIUM

B - 95

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

NYCOMED US
* NYCOMED US INC
ADAPALENE, ADAPALENE
ALVESCO, CICLESONIDE
CALCIPOTRIENE, CALCIPOTRIENE
CARMOL HC, HYDROCORTISONE ACETATE
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
DESOXIMETASONE, DESOXIMETASONE
IMIQUIMOD, IMIQUIMOD
LIDOCAINE AND PRILOCAINE, LIDOCAINE
MOMETASONE FUROATE, MOMETASONE FUROATE
OMNARIS, CICLESONIDE
TEMOVATE, CLOBETASOL PROPIONATE
TERCONAZOLE, TERCONAZOLE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE

ZONALON, DOXEPIN HYDROCHLORIDE

OAK PHARMS
* OAK PHARMACEUTICALS INC
EMLA, LIDOCAINE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

ODYSSEY PHARMS
* ODYSSEY PHARMACEUTICALS INC
ANTABUSE, DISULFIRAM
NYSTATIN, NYSTATIN
SURMONTIL, TRIMIPRAMINE MALEATE
URECHOLINE, BETHANECHOL CHLORIDE

VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE

OHM
* OHM CORP
IBUPROFEN,

IBUPROFEN

(OTC)

OHM LABS
* OHM LABORATORIES INC
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
IBUPROFEN, IBUPROFEN
IBUPROHM COLD AND SINUS, IBUPROFEN (OTC)
IBUPROHM, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

(OTC)

OLTA PHARMS
* OLTA PHARMACEUTICALS CORP
LINDANE, LINDANE
OMAN PHARM PRODUCTS
* OMAN PHARMACEUTICAL PRODUCTS CO LLC
NEOMYCIN SULFATE, NEOMYCIN SULFATE
ONCO THERAPIES LTD
* ONCO THERAPIES LTD
CARBOPLATIN, CARBOPLATIN
CLADRIBINE, CLADRIBINE
CYTARABINE, CYTARABINE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

PACLITAXEL, PACLITAXEL

ONY
* ONY INC
INFASURF PRESERVATIVE FREE,

CALFACTANT

B - 96

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

OPTIMER PHARMS
* OPTIMER PHARMACEUTICALS INC
DIFICID, FIDAXOMICIN
ORAPHARMA
* ORAPHARMA INC
ARESTIN, MINOCYCLINE HYDROCHLORIDE
ORCHID HLTHCARE
* ORCHID HEALTHCARE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
DESLORATADINE, DESLORATADINE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

* ORCHID HEALTHCARE DIV ORCHID CHEMICALS AND PHARMACEUTICALS LTD

ZALEPLON, ZALEPLON
ORGANON USA INC
* ORGANON USA INC
CYCLESSA, DESOGESTREL
DESOGEN, DESOGESTREL
FOLLISTIM AQ, FOLLITROPIN ALFA/BETA
GANIRELIX ACETATE INJECTION, GANIRELIX ACETATE
IMPLANON, ETONOGESTREL
NEXPLANON, ETONOGESTREL
NUVARING, ETHINYL ESTRADIOL
PREGNYL, GONADOTROPIN, CHORIONIC
REMERON SOLTAB, MIRTAZAPINE
REMERON, MIRTAZAPINE

SAPHRIS, ASENAPINE MALEATE

ORION
* ORION CORP
COMTAN, ENTACAPONE
STALEVO 100, CARBIDOPA
STALEVO 125, CARBIDOPA
STALEVO 150, CARBIDOPA
STALEVO 200, CARBIDOPA
STALEVO 50, CARBIDOPA

STALEVO 75, CARBIDOPA

ORIT LABS LLC

* ORIT LABORATORIES LLC
BENZONATATE, BENZONATATE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

ERGOCALCIFEROL, ERGOCALCIFEROL

ORPHAN EUROPE
* ORPHAN EUROPE
CARBAGLU, CARGLUMIC ACID
ORTHO BIOTECH
* ORTHO BIOTECH PRODUCTS LP
DOXIL, DOXORUBICIN HYDROCHLORIDE

B - 97

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

ORTHO JANSSEN
* ORTHO DERMATOLOGICS DIV JANSSEN PHARMACEUTICALS INC
ERTACZO, SERTACONAZOLE NITRATE
RENOVA, TRETINOIN

RETIN-A, TRETINOIN

ORTHO MCNEIL JANSSEN

* ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
NIZORAL, KETOCONAZOLE
ORTHONEUTROGENA
* ORTHONEUTROGENA
GRIFULVIN V, GRISEOFULVIN, MICROCRYSTALLINE
OSI PHARMS
* OSI PHARMACEUTICALS INC
TARCEVA, ERLOTINIB HYDROCHLORIDE
OSMOTICA PHARM
* OSMOTICA PHARMACEUTICAL CORP
NIFEDIPINE, NIFEDIPINE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

OTSUKA
* OTSUKA PHARMACEUTICAL CO LTD
ABILIFY, ARIPIPRAZOLE

PLETAL, CILOSTAZOL

* OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC

ABILIFY, ARIPIPRAZOLE
OTSUKA AMERICA
* OTSUKA AMERICA PHARMACEUTICALS INC
BREATHTEK UBT FOR H-PYLORI, UREA C-13
OTSUKA AMERICA PHARM
* OTSUKA AMERICA PHARMACEUTICAL INC
SAMSCA, TOLVAPTAN
OTSUKA PHARM
* OTSUKA PHARMACEUTICAL CO LTD
BUSULFEX, BUSULFAN
OUTLOOK PHARMS
* OUTLOOK PHARMACEUTICALS INC
DEXTROAMPHETAMINE SULFATE,
PACIFIC PHARMA
* PACIFIC PHARMA
TIMOLOL MALEATE,
* PACIFIC PHARMA INC
TIMOLOL MALEATE,

DEXTROAMPHETAMINE SULFATE

TIMOLOL MALEATE
TIMOLOL MALEATE

PACIRA PHARMS INC

* PACIRA PHARMACEUTICALS INC
DEPOCYT, CYTARABINE

EXPAREL, BUPIVACAINE

PACK PHARMS LLC

* PACK PHARMACEUTICALS LLC
CROMOLYN SODIUM, CROMOLYN SODIUM
PADDOCK
* PADDOCK LABORATORIES INC
BENZPHETAMINE HYDROCHLORIDE,

BENZPHETAMINE HYDROCHLORIDE

PADDOCK LABS
* PADDOCK LABORATORIES INC
CLINDAMYCIN PALMITATE HYDROCHLORIDE,
PADDOCK LLC
* PADDOCK LABORATORIES LLC
AMMONIUM LACTATE, AMMONIUM LACTATE

CLINDAMYCIN PALMITATE HYDROCHLORIDE

B - 98

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PADDOCK LABORATORIES LLC

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
CAFFEINE CITRATE, CAFFEINE CITRATE
CALCIUM ACETATE, CALCIUM ACETATE
CICLOPIROX, CICLOPIROX
CLENZ-LYTE, POLYETHYLENE GLYCOL 3350
CLINDA-DERM, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
COLOCORT, HYDROCORTISONE
COMPRO, PROCHLORPERAZINE
DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE
ERYTHRA-DERM, ERYTHROMYCIN
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
KIONEX, SODIUM POLYSTYRENE SULFONATE
LATANOPROST, LATANOPROST
LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
LORAZEPAM, LORAZEPAM
MIDAMOR, AMILORIDE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NYSTOP, NYSTATIN
PODOFILOX, PODOFILOX
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

PALADIN LABS
* PALADIN LABS USA INC
ANTIZOL, FOMEPIZOLE
PAR PHARM
* PAR PHARMACEUTICAL
NABUMETONE, NABUMETONE
OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

* PAR PHARMACEUTICAL INC

ALPRAZOLAM, ALPRAZOLAM
AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
CABERGOLINE, CABERGOLINE
CALCITONIN-SALMON, CALCITONIN SALMON
CAPOTEN, CAPTOPRIL
CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE
CHOLESTYRAMINE, CHOLESTYRAMINE
CLOMIPHENE CITRATE, CLOMIPHENE CITRATE
CLONAZEPAM, CLONAZEPAM
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DEXAMETHASONE, DEXAMETHASONE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

B - 99

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P

**

* PAR PHARMACEUTICAL INC

ESTAZOLAM, ESTAZOLAM
FLUTAMIDE, FLUTAMIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYUREA, HYDROXYUREA
IBUPROFEN, IBUPROFEN (OTC)
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
LEVETIRACETAM, LEVETIRACETAM
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
MEGACE ES, MEGESTROL ACETATE
MEGESTROL ACETATE, MEGESTROL ACETATE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METRONIDAZOLE, METRONIDAZOLE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MINOXIDIL, MINOXIDIL
NASCOBAL, CYANOCOBALAMIN
NATEGLINIDE, NATEGLINIDE
NYSTATIN, NYSTATIN
OLANZAPINE, OLANZAPINE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
OXANDROLONE, OXANDROLONE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TORSEMIDE, TORSEMIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

PARAPRO PHARMS
* PARAPRO PHARMACEUTICALS LLC
NATROBA, SPINOSAD
PARKE DAVIS
* PARKE DAVIS DIV WARNER LAMBERT CO
CELONTIN, METHSUXIMIDE
DILANTIN, PHENYTOIN SODIUM
DILANTIN-125, PHENYTOIN
NARDIL, PHENELZINE SULFATE
NEURONTIN, GABAPENTIN

ZARONTIN, ETHOSUXIMIDE

* PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO

ZARONTIN, ETHOSUXIMIDE
PBS
* PBS REGULATORY CONSULTING SERVICES INC
LEUKERAN, CHLORAMBUCIL
PEDIATRX
* PEDIATRX INC
GRANISETRON HYDROCHLORIDE,

GRANISETRON HYDROCHLORIDE

PEDINOL
* PEDINOL PHARMACAL INC
GRIS-PEG, GRISEOFULVIN, ULTRAMICROCRYSTALLINE

NALFON, FENOPROFEN CALCIUM

PERNIX THERAP
* PERNIX THERAPEUTICS LLC
CEDAX, CEFTIBUTEN DIHYDRATE
PERRIGO
* L PERRIGO CO
ACETAMINOPHEN,

ACETAMINOPHEN

(OTC)

B - 100

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P

**

* L PERRIGO CO
ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC)
CHILDREN'S IBUPROFEN, IBUPROFEN (OTC)
CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)
DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)
FAMOTIDINE, FAMOTIDINE (OTC)
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LORATADINE, LORATADINE (OTC)
MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
TAB-PROFEN, IBUPROFEN (OTC)

TIOCONAZOLE, TIOCONAZOLE (OTC)

* PERRIGO CO
CICLOPIROX, CICLOPIROX
CIMETIDINE, CIMETIDINE (OTC)
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC)
CLINDETS, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
ERYTHROMYCIN, ERYTHROMYCIN
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
IBUPROFEN, IBUPROFEN (OTC)
JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
STIE-CORT, HYDROCORTISONE
PERRIGO CO TENNESSEE
* PERRIGO CO TENNESSEE INC
GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

PERRIGO ISRAEL
* PERRIGO ISRAEL PHARMACEUTICALS LTD
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
IMIQUIMOD, IMIQUIMOD
KETOCONAZOLE, KETOCONAZOLE
MESALAMINE, MESALAMINE

MINOXIDIL, MINOXIDIL (OTC)

PERRIGO NEW YORK

* PERRIGO NEW YORK INC
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
AMMONIUM LACTATE, AMMONIUM LACTATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CENTANY, MUPIROCIN
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DESONIDE, DESONIDE
DESOXIMETASONE, DESOXIMETASONE
ECONAZOLE NITRATE, ECONAZOLE NITRATE

ERYTHROMYCIN, ERYTHROMYCIN

B - 101

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PERRIGO NEW YORK INC

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE
HYDROCORTISONE, HYDROCORTISONE
KETOCONAZOLE, KETOCONAZOLE
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPIROCIN, MUPIROCIN
NYSTATIN, NYSTATIN
PERMETHRIN, PERMETHRIN
PERMETHRIN, PERMETHRIN (OTC)
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
SELENIUM SULFIDE, SELENIUM SULFIDE
TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

PERRIGO R AND D
* PERRIGO R AND D CO
CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE (OTC)
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
DESLORATADINE, DESLORATADINE
GUAIFENESIN, GUAIFENESIN (OTC)
IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL (OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
NAPROXEN, NAPROXEN
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

* PERRIGO R AND D COMPANY

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

PERRIGO UK FINCO
* PERRIGO UK FINCO LTD PARTNERSHIP
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
PETNET
* PETNET SOLUTIONS INC
FLUDEOXYGLUCOSE F18,

FLUDEOXYGLUCOSE F-18

PFIZER
* PFIZER CENTRAL RESEARCH
DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER CHEMICALS DIV PFIZER INC

DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER INC
ANTIVERT, MECLIZINE HYDROCHLORIDE
ARGATROBAN, ARGATROBAN
CADUET, AMLODIPINE BESYLATE
CARDURA XL, DOXAZOSIN MESYLATE
CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

B - 102

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** P

**

* PFIZER INC
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE
FLUMAZENIL, FLUMAZENIL
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GEODON, ZIPRASIDONE HYDROCHLORIDE
GEODON, ZIPRASIDONE MESYLATE
GLUCOTROL XL, GLIPIZIDE
GLUCOTROL, GLIPIZIDE
HALOPERIDOL, HALOPERIDOL LACTATE
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
ISOPTIN SR, VERAPAMIL HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LIPITOR, ATORVASTATIN CALCIUM
NAVANE, THIOTHIXENE
NORVASC, AMLODIPINE BESYLATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PROCARDIA, NIFEDIPINE
REVATIO, SILDENAFIL CITRATE
RIFAMPIN, RIFAMPIN
TOVIAZ, FESOTERODINE FUMARATE
UNASYN, AMPICILLIN SODIUM
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VFEND, VORICONAZOLE
XALKORI, CRIZOTINIB

ZITHROMAX, AZITHROMYCIN

* PFIZER LABORATORIES DIV PFIZER INC

CARDURA, DOXAZOSIN MESYLATE
DIABINESE, CHLORPROPAMIDE
FELDENE, PIROXICAM
MINIPRESS, PRAZOSIN HYDROCHLORIDE
PERMAPEN, PENICILLIN G BENZATHINE
PFIZERPEN, PENICILLIN G POTASSIUM
PROCARDIA XL, NIFEDIPINE
TERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINE HYDROCHLORIDE
UNASYN, AMPICILLIN SODIUM
VIBRAMYCIN, DOXYCYCLINE
VIBRAMYCIN, DOXYCYCLINE CALCIUM
VIBRAMYCIN, DOXYCYCLINE HYCLATE

VISTARIL, HYDROXYZINE PAMOATE

* PFIZER PHARMACEUTICALS INC

ZOLOFT, SERTRALINE HYDROCHLORIDE
* PFIZER PHARMACEUTICALS PRODUCTION CORP LTD
TIKOSYN, DOFETILIDE
PFIZER CONS HLTHCARE
* PFIZER CONSUMER HEALTHCARE
ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE
ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)

PFIZER GLOBAL
* PFIZER GLOBAL RESEARCH DEVELOPMENT
ZMAX, AZITHROMYCIN
PFIZER INC
* PFIZER INC
CAMPTOSAR, IRINOTECAN HYDROCHLORIDE
CHANTIX, VARENICLINE TARTRATE
ELLENCE, EPIRUBICIN HYDROCHLORIDE
GEODON, ZIPRASIDONE HYDROCHLORIDE

NICOTROL, NICOTINE

(OTC)

B - 103

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

PFIZER IRELAND
* PFIZER IRELAND PHARMACEUTICALS
RELPAX, ELETRIPTAN HYDROBROMIDE

VIAGRA, SILDENAFIL CITRATE

PFIZER PHARMS
* PFIZER PHARMACEUTICALS LTD
ACCUPRIL, QUINAPRIL HYDROCHLORIDE
ACCURETIC, HYDROCHLOROTHIAZIDE
DILANTIN, PHENYTOIN
LOPID, GEMFIBROZIL
NEURONTIN, GABAPENTIN

NITROSTAT, NITROGLYCERIN

PHARM ASSOC
* PHARMACEUTICAL ASSOC INC
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
LORAZEPAM, LORAZEPAM
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

* PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
ETHOSUXIMIDE, ETHOSUXIMIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL LACTATE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
LACTULOSE, LACTULOSE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PREDNISOLONE, PREDNISOLONE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

VALPROIC ACID, VALPROIC ACID

PHARMA SERVE NY
* PHARMA SERVE INC SUB TORIGIAN LABORATORIES
AMINOPHYLLINE, AMINOPHYLLINE
PHARMACHEMIE
* PHARMACHEMIE BV
CARBOPLATIN, CARBOPLATIN
CISPLATIN, CISPLATIN
DOXORUBICIN HYDROCHLORIDE,
ETOPOSIDE, ETOPOSIDE

DOXORUBICIN HYDROCHLORIDE

PHARMACHEMIE BV
* PHARMACHEMIE BV
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
CARBOPLATIN, CARBOPLATIN

METHOTREXATE SODIUM PRESERVATIVE FREE,

PHARMACIA AND UPJOHN
* PHARMACIA AND UPJOHN
XANAX XR, ALPRAZOLAM
* PHARMACIA AND UPJOHN CO
ANSAID, FLURBIPROFEN
AROMASIN, EXEMESTANE
AZULFIDINE EN-TABS, SULFASALAZINE
AZULFIDINE, SULFASALAZINE
BACITRACIN, BACITRACIN

CAVERJECT IMPULSE, ALPROSTADIL

METHOTREXATE SODIUM

B - 104

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PHARMACIA AND UPJOHN CO

CAVERJECT, ALPROSTADIL
CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER,
CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLEOCIN T, CLINDAMYCIN PHOSPHATE
CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLEOCIN, CLINDAMYCIN PHOSPHATE
COLESTID, COLESTIPOL HYDROCHLORIDE
CORTEF, HYDROCORTISONE
CORVERT, IBUTILIDE FUMARATE
CYKLOKAPRON, TRANEXAMIC ACID
DEPO-ESTRADIOL, ESTRADIOL CYPIONATE
DEPO-MEDROL, METHYLPREDNISOLONE ACETATE
DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE
DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE
DETROL LA, TOLTERODINE TARTRATE
DETROL, TOLTERODINE TARTRATE
DIDREX, BENZPHETAMINE HYDROCHLORIDE
EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM
ESTRING, ESTRADIOL
FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE
GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT
GENOTROPIN, SOMATROPIN RECOMBINANT
GLYNASE, GLYBURIDE
GLYSET, MIGLITOL
HALCION, TRIAZOLAM
HEMABATE, CARBOPROST TROMETHAMINE
IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE
LINCOCIN, LINCOMYCIN HYDROCHLORIDE
MEDROL, METHYLPREDNISOLONE
MYCOBUTIN, RIFABUTIN
NICOTROL, NICOTINE
OGEN .625, ESTROPIPATE
OGEN 1.25, ESTROPIPATE
OGEN 2.5, ESTROPIPATE
OGEN 5, ESTROPIPATE
PREPIDIL, DINOPROSTONE
PROSTIN E2, DINOPROSTONE
PROSTIN VR PEDIATRIC, ALPROSTADIL
PROVERA, MEDROXYPROGESTERONE ACETATE
R-GENE 10, ARGININE HYDROCHLORIDE
SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE
SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE
SOMAVERT, PEGVISOMANT
XALATAN, LATANOPROST
XANAX, ALPRAZOLAM
ZINECARD, DEXRAZOXANE HYDROCHLORIDE

ZYVOX, LINEZOLID

* PHARMACIA AND UPJOHN SUB PFIZER INC

DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE

CLINDAMYCIN PHOSPHATE

PHARMAFORCE
* PHARMAFORCE INC
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
NANDROLONE DECANOATE, NANDROLONE DECANOATE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

PHARMALUCENCE
* PHARMALUCENCE INC
AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT
AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT

CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT

B - 105

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* PHARMALUCENCE INC
CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT
HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT
PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT

PHARMAX
* PHARMAX GROUP INC
BETHANECHOL CHLORIDE,
PHARMAXIS
* PHARMAXIS INC
ARIDOL KIT,

BETHANECHOL CHLORIDE

MANNITOL

PIERRE FABRE
* PIERRE FABRE MEDICAMENT
NAVELBINE, VINORELBINE TARTRATE
PIERREL
* PIERREL S.P.A.
ARTICAINE HYDROCHLORIDE WITH EPINEPHRINE,

ARTICAINE HYDROCHLORIDE

PINNACLE BIOLGS
* PINNACLE BIOLOGICS INC
PHOTOFRIN, PORFIMER SODIUM
PIRAMAL CRITICAL
* PIRAMAL CRITICAL CARE INC
ENFLURANE, ENFLURANE
ISOFLURANE, ISOFLURANE

SOJOURN, SEVOFLURANE

PLANTEX
* PLANTEX USA INC DIV IKAPHARM INC
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH,

SULFAMETHOXAZOLE

PLIVA
* PLIVA INC
AZITHROMYCIN, AZITHROMYCIN
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CARBOPLATIN, CARBOPLATIN
CHLORPROPAMIDE, CHLORPROPAMIDE
CHLORTHALIDONE, CHLORTHALIDONE
CIMETIDINE, CIMETIDINE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOSPORINE, CYCLOSPORINE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
KETOCONAZOLE, KETOCONAZOLE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
METRONIDAZOLE, METRONIDAZOLE
NAPROXEN, NAPROXEN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PENTOXIFYLLINE, PENTOXIFYLLINE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

WARFARIN SODIUM, WARFARIN SODIUM

B - 106

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

PLIVA HRVATSKA DOO

* PLIVA HRVATSKA DOO
ADAPALENE, ADAPALENE
AZITHROMYCIN, AZITHROMYCIN
CARVEDILOL, CARVEDILOL
CILOSTAZOL, CILOSTAZOL
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RISPERIDONE, RISPERIDONE

PLIVA LACHEMA
* PLIVA LACHEMA AS
CARBOPLATIN, CARBOPLATIN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PLIVA PHARM IND

* PLIVA PHARMACEUTICAL INDUSTRY INC
TORSEMIDE, TORSEMIDE
POHL BOSKAMP
* POHL BOSKAMP
NITROLINGUAL PUMPSPRAY,

NITROGLYCERIN

POLYMEDICA
* POLYMEDICA INDUSTRIES INC
ANESTACON, LIDOCAINE HYDROCHLORIDE

NEOPAP, ACETAMINOPHEN (OTC)

PRASCO
* PRASCO LLC DBA PRASCO LABORATORIES
ECONAZOLE NITRATE, ECONAZOLE NITRATE
PRECISION DERMAT
* PRECISION DERMATOLOGY INC
PODOFILOX, PODOFILOX
PRECISION DOSE
* PRECISION DOSE INC
RISPERIDONE, RISPERIDONE
PRINSTON INC
* PRINSTON PHARMACEUTICAL INC
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
CAPTOPRIL, CAPTOPRIL
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

PROCTER AND GAMBLE

* PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
DIDRONEL, ETIDRONATE DISODIUM
PROGENICS
* PROGENICS PHARMACEUTICALS INC
RELISTOR, METHYLNALTREXONE BROMIDE
PROMETHEUS LABS
* PROMETHEUS LABORATORIES INC
HELIDAC, BISMUTH SUBSALICYLATE
IMURAN, AZATHIOPRINE
LOTRONEX, ALOSETRON HYDROCHLORIDE
MERCAPTOPURINE, MERCAPTOPURINE
RIDAURA, AURANOFIN
TRANDATE, LABETALOL HYDROCHLORIDE

ZYLOPRIM, ALLOPURINOL

B - 107

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

PROMIUS PHARMA
* PROMIUS PHARMA LLC
SECTRAL, ACEBUTOLOL HYDROCHLORIDE

TENEX, GUANFACINE HYDROCHLORIDE

PROMIUS PHARMA LLC

* PROMIUS PHARMA LLC
CLODERM, CLOCORTOLONE PIVALATE
PROSAM LABS
* PROSAM LABS LLC
BACLOFEN, BACLOFEN
CARISOPRODOL AND ASPIRIN, ASPIRIN
CARISOPRODOL, CARISOPRODOL
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

PROSTRAKAN INC
* PROSTRAKAN INC
ABSTRAL, FENTANYL CITRATE
RECTIV, NITROGLYCERIN

SANCUSO, GRANISETRON

PROVIDENT PHARM
* PROVIDENT PHARMACEUTICAL INC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PULSION MEDCL
* PULSION MEDICAL SYSTEMS AG
INDOCYANINE GREEN, INDOCYANINE GREEN
PURACAP PHARM
* PURACAP PHARMACEUTICAL LLC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

MELOXICAM, MELOXICAM

PURDUE GMP
* PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHARMACY
SEROMYCIN, CYCLOSERINE
PURDUE PHARM PRODS
* PURDUE PHARMACEUTICAL PRODUCTS LP
DILAUDID, HYDROMORPHONE HYDROCHLORIDE

DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE

PURDUE PHARMA
* PURDUE PHARMA PRODUCTS LP
INTERMEZZO, ZOLPIDEM TARTRATE

RYZOLT, TRAMADOL HYDROCHLORIDE

PURDUE PHARMA LP
* PURDUE PHARMA LP
BUTRANS, BUPRENORPHINE
MS CONTIN, MORPHINE SULFATE

OXYCONTIN, OXYCODONE HYDROCHLORIDE

PUREPAC PHARM
* PUREPAC PHARMACEUTICAL CO
DIPYRIDAMOLE, DIPYRIDAMOLE
QLT
* QLT INC
VISUDYNE,

VERTEPORFIN

QOL MEDCL
* QOL MEDICAL LLC
ELLIOTTS B SOLUTION, CALCIUM CHLORIDE
ETHAMOLIN, ETHANOLAMINE OLEATE

SUCRAID, SACROSIDASE

B - 108

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

QUESTCOR PHARMS
* QUESTCOR PHARMACEUTICALS INC
DORAL, QUAZEPAM
H.P. ACTHAR GEL, CORTICOTROPIN
RANBAXY
* RANBAXY INC
GLYCOPYRROLATE, GLYCOPYRROLATE
* RANBAXY LABORATORIES INC
EURAX, CROTAMITON
EXELDERM, SULCONAZOLE NITRATE
FAMOTIDINE, FAMOTIDINE (OTC)
HALOG, HALCINONIDE
KENALOG, TRIAMCINOLONE ACETONIDE
LAC-HYDRIN, AMMONIUM LACTATE
RISPERIDONE, RISPERIDONE
ULTRAVATE, HALOBETASOL PROPIONATE

WESTCORT, HYDROCORTISONE VALERATE

* RANBAXY LABORATORIES LTD

ACYCLOVIR, ACYCLOVIR
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CLARITHROMYCIN, CLARITHROMYCIN
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DISPERMOX, AMOXICILLIN
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXYCYCLINE, DOXYCYCLINE
FENOFIBRATE, FENOFIBRATE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
GANCICLOVIR, GANCICLOVIR
GLIMEPIRIDE, GLIMEPIRIDE
LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)
LORATADINE REDIDOSE, LORATADINE (OTC)
LORATADINE, LORATADINE (OTC)
LORAZEPAM, LORAZEPAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN
OFLOXACIN, OFLOXACIN
ONDANSETRON, ONDANSETRON

OXCARBAZEPINE, OXCARBAZEPINE

B - 109

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** R

**

* RANBAXY LABORATORIES LTD

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RANICLOR, CEFACLOR
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
SOTRET, ISOTRETINOIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
ZIDOVUDINE, ZIDOVUDINE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* RANBAXY PHARMACEUTICALS INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
AVENTYL HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
CEFACLOR, CEFACLOR
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)
PENTAZOCINE AND NALOXONE HYDROCHLORIDES, NALOXONE HYDROCHLORIDE
RIOMET, METFORMIN HYDROCHLORIDE

SOTRET, ISOTRETINOIN

RANBAXY LABS LTD

* RANBAXY LABORATORIES LIMITED
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
* RANBAXY LABORATORIES LTD
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

RARE DIS
* RARE DISEASE THERAPEUTICS INC
ORFADIN, NITISINONE
RARE DIS THERAP
* RARE DISEASE THERAPEUTICS INC
CYSTADANE, BETAINE HYDROCHLORIDE
RECIP
* RECIP AB
THYROSAFE,

POTASSIUM IODIDE

(OTC)

RECKITT BENCKISER
* RECKITT BENCKISER
DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC)
* RECKITT BENCKISER INC
MUCINEX D, GUAIFENESIN (OTC)
MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

MUCINEX, GUAIFENESIN (OTC)

* RECKITT BENCKISER PHARMACEUTICALS INC

BUPRENEX, BUPRENORPHINE HYDROCHLORIDE
SUBOXONE, BUPRENORPHINE
SUBOXONE, BUPRENORPHINE HYDROCHLORIDE

SUBUTEX, BUPRENORPHINE HYDROCHLORIDE

B - 110

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

REDDYS
* DOCTOR REDDYS LABORATORIES LTD
DESLORATADINE, DESLORATADINE
RHODES PHARMS
* RHODES PHARMACEUTICALS LP
MORPHINE SULFATE, MORPHINE SULFATE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

RHODIA
* RHODIA LTD
ISOFLURANE,

ISOFLURANE

RITEDOSE CORP
* THE RITEDOSE CORP
ALBUTEROL SULFATE, ALBUTEROL SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

ROCHE
* HOFFMANN LA ROCHE INC
BONIVA, IBANDRONATE SODIUM
COPEGUS, RIBAVIRIN
FUZEON, ENFUVIRTIDE
INVIRASE, SAQUINAVIR MESYLATE
KLONOPIN, CLONAZEPAM
TAMIFLU, OSELTAMIVIR PHOSPHATE

VALIUM, DIAZEPAM

ROCHE PALO
* ROCHE PALO ALTO LLC
AEROBID, FLUNISOLIDE
ANAPROX DS, NAPROXEN SODIUM
ANAPROX, NAPROXEN SODIUM
CELLCEPT, MYCOPHENOLATE MOFETIL
CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE
CYTOVENE, GANCICLOVIR SODIUM
EC-NAPROSYN, NAPROXEN
NAPROSYN, NAPROXEN

VALCYTE, VALGANCICLOVIR HYDROCHLORIDE

ROCKWELL MEDCL
* ROCKWELL MEDICAL TECHNOLOGIES INC
CALCITRIOL, CALCITRIOL
ROMARK
* ROMARK LABORATORIES
ALINIA, NITAZOXANIDE
ROSEDALE THERAPEUTIC
* ROSEDALE THERAPEUTICS
ERGOMAR, ERGOTAMINE TARTRATE
ROSS LABS
* ROSS LABORATORIES DIV ABBOTT LABORATORIES INC
SURVANTA, BERACTANT
ROXANE
* ROXANE LABORATORIES INC
ACARBOSE, ACARBOSE
ALPRAZOLAM, ALPRAZOLAM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
AZATHIOPRINE, AZATHIOPRINE
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BICALUTAMIDE, BICALUTAMIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CALCITRIOL, CALCITRIOL
CALCIUM ACETATE, CALCIUM ACETATE

CILOSTAZOL, CILOSTAZOL

B - 111

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ROXANE LABORATORIES INC

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
CLOTRIMAZOLE, CLOTRIMAZOLE
CODEINE SULFATE, CODEINE SULFATE
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
DEXAMETHASONE INTENSOL, DEXAMETHASONE
DEXAMETHASONE, DEXAMETHASONE
DIAZEPAM INTENSOL, DIAZEPAM
DIAZEPAM, DIAZEPAM
DIGOXIN, DIGOXIN
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXERCALCIFEROL, DOXERCALCIFEROL
EXEMESTANE, EXEMESTANE
FAMCICLOVIR, FAMCICLOVIR
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUCONAZOLE, FLUCONAZOLE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
FUROSEMIDE, FUROSEMIDE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LACTULOSE, LACTULOSE
LETROZOLE, LETROZOLE
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEVETIRACETAM, LEVETIRACETAM
LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
LITHIUM CARBONATE, LITHIUM CARBONATE
LITHIUM CITRATE, LITHIUM CITRATE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LORAZEPAM INTENSOL, LORAZEPAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEGESTROL ACETATE, MEGESTROL ACETATE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
MERCAPTOPURINE, MERCAPTOPURINE
METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NAPROXEN, NAPROXEN
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PREDNISONE INTENSOL, PREDNISONE
PREDNISONE, PREDNISONE
PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

B - 112

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ROXANE LABORATORIES INC

ROXICET 5/500, ACETAMINOPHEN
ROXICET, ACETAMINOPHEN
ROXILOX, ACETAMINOPHEN
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
TORSEMIDE, TORSEMIDE
TRIAZOLAM, TRIAZOLAM
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
ZALEPLON, ZALEPLON
ZIDOVUDINE, ZIDOVUDINE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

SAGE PRODS
* SAGE PRODUCTS INC
CHLORHEXIDINE GLUCONATE,

CHLORHEXIDINE GLUCONATE

(OTC)

SAGENT PHARMS
* SAGENT PHARMACEUTICALS INC
CALCITRIOL, CALCITRIOL
HALOPERIDOL, HALOPERIDOL LACTATE
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
LEVOFLOXACIN, LEVOFLOXACIN
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

SAGENT STRIDES
* SAGENT STRIDES LLC
AZITHROMYCIN, AZITHROMYCIN
BACITRACIN, BACITRACIN
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
LABETALOL HYDROCLORIDE, LABETALOL HYDROCHLORIDE
MESNA, MESNA
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE
MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
POLYMYCIN B SULFATE, POLYMYXIN B SULFATE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

SALIX PHARMS
* SALIX PHARMACEUTICALS INC
ANUSOL HC, HYDROCORTISONE
APRISO, MESALAMINE
COLAZAL, BALSALAZIDE DISODIUM
DIURIL, CHLOROTHIAZIDE
METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE
MOVIPREP, ASCORBIC ACID
OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
PEPCID, FAMOTIDINE
VISICOL, SODIUM PHOSPHATE, DIBASIC ANHYDROUS

XIFAXAN, RIFAXIMIN

SAMSON MEDCL
* SAMSON MEDICAL TECHNOLOGIES LLC
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFUROXIME SODIUM IN PLASTIC CONTAINER,

CEFUROXIME SODIUM

SANDOZ
* SANDOZ
DOCETAXEL, DOCETAXEL
* SANDOZ CANADA INC
ANECTINE, SUCCINYLCHOLINE CHLORIDE
ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

B - 113

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SANDOZ CANADA INC

COSYNTROPIN, COSYNTROPIN
DIGOXIN, DIGOXIN
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
ESTRADIOL VALERATE, ESTRADIOL VALERATE
FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE
FLUMAZENIL, FLUMAZENIL
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID
INFUVITE PEDIATRIC, ASCORBIC ACID
ISONIAZID, ISONIAZID
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
REGONOL, PYRIDOSTIGMINE BROMIDE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

* SANDOZ INC
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALPRAZOLAM, ALPRAZOLAM
ALTAVERA, ETHINYL ESTRADIOL
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
ANASTROZOLE, ANASTROZOLE
ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN
ATENOLOL, ATENOLOL
ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE
AZITHROMYCIN, AZITHROMYCIN
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BICALUTAMIDE, BICALUTAMIDE
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
BUMETANIDE, BUMETANIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CAFERGOT, CAFFEINE
CAPTOPRIL, CAPTOPRIL
CARBOPLATIN, CARBOPLATIN
CARISOPRODOL AND ASPIRIN, ASPIRIN
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFDINIR, CEFDINIR
CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CEFTRIAXONE, CEFTRIAXONE SODIUM

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

B - 114

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APPENDIX B

B - 115

PRODUCT NAME SORTED BY APPLICANT

**

**

* SANDOZ INC
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
(OTC)
CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE
CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE
CHOLESTYRAMINE, CHOLESTYRAMINE
CILOSTAZOL, CILOSTAZOL
CIMETIDINE, CIMETIDINE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC)
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOSPORINE, CYCLOSPORINE
DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE
DESLORATADINE, DESLORATADINE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
ASPARTATE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

EPLERENONE, EPLERENONE

ETODOLAC, ETODOLAC

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUOROURACIL, FLUOROURACIL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLUTAMIDE, FLUTAMIDE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

FUROSEMIDE, FUROSEMIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GLIPIZIDE, GLIPIZIDE

HALOPERIDOL, HALOPERIDOL

HEPARIN SODIUM, HEPARIN SODIUM

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

INDAPAMIDE, INDAPAMIDE

INDOMETHACIN, INDOMETHACIN

INTROVALE, ETHINYL ESTRADIOL

INVAGESIC FORTE, ASPIRIN

INVAGESIC, ASPIRIN

ISONIAZID, ISONIAZID

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

ITRACONAZOLE, ITRACONAZOLE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

LANSOPRAZOLE, LANSOPRAZOLE

LEFLUNOMIDE, LEFLUNOMIDE

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SANDOZ INC
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOCHOLEST LIGHT, CHOLESTYRAMINE
LOCHOLEST, CHOLESTYRAMINE
LONOX, ATROPINE SULFATE
LORATADINE, LORATADINE (OTC)
LORAZEPAM, LORAZEPAM
LORYNA, DROSPIRENONE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOVASTATIN, LOVASTATIN
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEROPENEM, MEROPENEM
METAXALONE, METAXALONE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHAZOLAMIDE, METHAZOLAMIDE
METHIMAZOLE, METHIMAZOLE
METHOCARBAMOL, METHOCARBAMOL
METHYLPREDNISOLONE, METHYLPREDNISOLONE
METOLAZONE, METOLAZONE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NABUMETONE, NABUMETONE
NADOLOL, NADOLOL
NAFCILLIN SODIUM, NAFCILLIN SODIUM
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NAPROXEN, NAPROXEN
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN
NIZATIDINE, NIZATIDINE
OFLOXACIN, OFLOXACIN
OMEPRAZOLE, OMEPRAZOLE
OMNITROPE, SOMATROPIN RECOMBINANT
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN
OXACILLIN SODIUM, OXACILLIN SODIUM
OXALIPLATIN, OXALIPLATIN
OXANDROLONE, OXANDROLONE
OXAPROZIN, OXAPROZIN
OXAZEPAM, OXAZEPAM
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
PENICILLIN G SODIUM, PENICILLIN G SODIUM
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PERPHENAZINE, PERPHENAZINE
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

QUINIDINE SULFATE, QUINIDINE SULFATE

B - 116

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S

**

* SANDOZ INC
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RESERPINE, RESERPINE
RIBAVIRIN, RIBAVIRIN
RIFAMPIN, RIFAMPIN
RISPERIDONE, RISPERIDONE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SPIRONOLACTONE, SPIRONOLACTONE
SULFADIAZINE, SULFADIAZINE
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
SYEDA, DROSPIRENONE
TACROLIMUS, TACROLIMUS
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TEMAZEPAM, TEMAZEPAM
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
THIOTHIXENE, THIOTHIXENE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

SANDOZ CANADA INC

* SANDOZ CANADA INC
PARICALCITOL, PARICALCITOL
SANDOZ INC
* SANDOZ INC
DOCETAXEL, DOCETAXEL
ENOXAPARIN SODIUM, ENOXAPARIN SODIUM

VORICONAZOLE, VORICONAZOLE

SANOCHEMIA CORP USA

* SANOCHEMIA CORP USA
SCANLUX-300, IOPAMIDOL

SCANLUX-370, IOPAMIDOL

SANOFI AVENTIS
* SANOFI AVENTIS
AVALIDE, HYDROCHLOROTHIAZIDE
SANOFI AVENTIS US
* SANOFI AVENTIS US INC
JEVTANA KIT, CABAZITAXEL
* SANOFI AVENTIS US LLC
ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLEGRA, FEXOFENADINE HYDROCHLORIDE
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE
AMARYL, GLIMEPIRIDE
AMBIEN CR, ZOLPIDEM TARTRATE
AMBIEN, ZOLPIDEM TARTRATE
ANZEMET, DOLASETRON MESYLATE
APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT
APIDRA, INSULIN GLULISINE RECOMBINANT
ARALEN, CHLOROQUINE PHOSPHATE
ARAVA, LEFLUNOMIDE
AVAPRO, IRBESARTAN

BENZACLIN, BENZOYL PEROXIDE

(OTC)
(OTC)

B - 117

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SANOFI AVENTIS US LLC

BENZAMYCIN PAK, BENZOYL PEROXIDE
BENZAMYCIN, BENZOYL PEROXIDE
CANTIL, MEPENZOLATE BROMIDE
CARAC, FLUOROURACIL
CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM
CLAFORAN, CEFOTAXIME SODIUM
CLOMID, CLOMIPHENE CITRATE
DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
DDAVP, DESMOPRESSIN ACETATE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DERMATOP E EMOLLIENT, PREDNICARBATE
DERMATOP, PREDNICARBATE
DIABETA, GLYBURIDE
DRISDOL, ERGOCALCIFEROL
ELOXATIN, OXALIPLATIN
FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX
GAVISCON, ALUMINUM HYDROXIDE (OTC)
HIPREX, METHENAMINE HIPPURATE
KAYEXALATE, SODIUM POLYSTYRENE SULFONATE
KETEK, TELITHROMYCIN
KLARON, SULFACETAMIDE SODIUM
LANTUS, INSULIN GLARGINE RECOMBINANT
LASIX, FUROSEMIDE
LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM
LOVENOX, ENOXAPARIN SODIUM
MULTAQ, DRONEDARONE HYDROCHLORIDE
MYTELASE, AMBENONIUM CHLORIDE
NASACORT AQ, TRIAMCINOLONE ACETONIDE
NICODERM CQ, NICOTINE (OTC)
NILANDRON, NILUTAMIDE
NORITATE, METRONIDAZOLE
NORPRAMIN, DESIPRAMINE HYDROCHLORIDE
OFORTA, FLUDARABINE PHOSPHATE
PENLAC, CICLOPIROX
PHISOHEX, HEXACHLOROPHENE
PLAQUENIL, HYDROXYCHLOROQUINE SULFATE
PLAVIX, CLOPIDOGREL BISULFATE
PRIFTIN, RIFAPENTINE
PRIMAQUINE, PRIMAQUINE PHOSPHATE
RIFADIN, RIFAMPIN
RIFAMATE, ISONIAZID
RIFATER, ISONIAZID
RILUTEK, RILUZOLE
SKELID, TILUDRONATE DISODIUM
TAXOTERE, DOCETAXEL
TRENTAL, PENTOXIFYLLINE

UROXATRAL, ALFUZOSIN HYDROCHLORIDE

SANTARUS
* SANTARUS INC
FENOGLIDE, FENOFIBRATE
GLUMETZA, METFORMIN HYDROCHLORIDE
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE,
ZEGERID, OMEPRAZOLE
SANTEN
* SANTEN INC
ALAMAST, PEMIROLAST POTASSIUM
IQUIX, LEVOFLOXACIN

QUIXIN, LEVOFLOXACIN

MAGNESIUM HYDROXIDE

B - 118

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

SANTEN OY
* SANTEN OY
BETIMOL,

**

TIMOLOL

SANTOS BIOTECH
* SANTOS BIOTECH INDUSTRIES INC
ANASTROZOLE, ANASTROZOLE
SAVAGE LABS
* SAVAGE LABORATORIES INC DIV ALTANA INC
KAON CL-10, POTASSIUM CHLORIDE
SAVIENT PHARMS
* SAVIENT PHARMACEUTICALS INC
OXANDRIN, OXANDROLONE
SB PHARMCO
* SB PHARMCO PUERTO RICO INC
AVANDAMET, METFORMIN HYDROCHLORIDE
AVANDARYL, GLIMEPIRIDE
AVANDIA, ROSIGLITAZONE MALEATE

COREG CR, CARVEDILOL PHOSPHATE

SCHERING
* MERCK, INC.
CLARINEX D 24 HOUR, DESLORATADINE
* SCHERING
CLARINEX-D 12 HOUR, DESLORATADINE
* SCHERING CORP
ASMANEX TWISTHALER, MOMETASONE FUROATE
CLARINEX, DESLORATADINE
DIPROLENE AF, BETAMETHASONE DIPROPIONATE
DULERA, FORMOTEROL FUMARATE
GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE
INTEGRILIN, EPTIFIBATIDE
LOTRISONE, BETAMETHASONE DIPROPIONATE
NOXAFIL, POSACONAZOLE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
REBETOL, RIBAVIRIN
TEMODAR, TEMOZOLOMIDE
VICTRELIS, BOCEPREVIR

ZEMURON, ROCURONIUM BROMIDE

* SCHERING CORP SUB SCHERING PLOUGH CORP

CELESTONE SOLUSPAN, BETAMETHASONE ACETATE
CELESTONE, BETAMETHASONE
DIPROLENE, BETAMETHASONE DIPROPIONATE

ELOCON, MOMETASONE FUROATE

SCHERING PLOUGH
* SCHERING PLOUGH CORP
CLARINEX, DESLORATADINE
* SCHERING PLOUGH HEALTHCARE PRODUCTS INC
AFRINOL, PSEUDOEPHEDRINE SULFATE (OTC)
CHILDREN'S CLARITIN, LORATADINE (OTC)
CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC)
CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC)
CLARITIN HIVES RELIEF, LORATADINE (OTC)
CLARITIN REDITABS, LORATADINE (OTC)
CLARITIN, LORATADINE (OTC)
CLARITIN-D 24 HOUR, LORATADINE (OTC)
CLARITIN-D, LORATADINE (OTC)
DISOPHROL, DEXBROMPHENIRAMINE MALEATE (OTC)
DRIXORAL PLUS, ACETAMINOPHEN (OTC)
DRIXORAL, DEXBROMPHENIRAMINE MALEATE (OTC)
GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN 3, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE (OTC)

GYNE-LOTRIMIN, CLOTRIMAZOLE (OTC)

B - 119

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S

**

* SCHERING PLOUGH HEALTHCARE PRODUCTS INC

LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC)
MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC)
NASONEX, MOMETASONE FUROATE MONOHYDRATE
OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE (OTC)

SHADE UVAGUARD, AVOBENZONE (OTC)

SCHERING PLOUGH RES

* SCHERING PLOUGH RESEARCH INSTITUTE
LOTRISONE, BETAMETHASONE DIPROPIONATE

REBETOL, RIBAVIRIN

SCHWARZ PHARMA
* SCHWARZ PHARMA AG
EDEX, ALPROSTADIL
* SCHWARZ PHARMA INC
DILATRATE-SR, ISOSORBIDE DINITRATE
LEVATOL, PENBUTOLOL SULFATE
NIRAVAM, ALPRAZOLAM
PARCOPA, CARBIDOPA
ROBAXIN, METHOCARBAMOL

ROBAXIN-750, METHOCARBAMOL

SCIOS
* SCIOS INC
NATRECOR,

NESIRITIDE RECOMBINANT

SECAN PHARMS
* SECAN PHARMACEUTICALS INC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
SEPTODONT
* SEPTODONT INC
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE,
OCTOCAINE, EPINEPHRINE

BUPIVACAINE HYDROCHLORIDE

SEPTODONT HOLDING
* SEPTODONT HOLDING SAS
ORAVERSE, PHENTOLAMINE MESYLATE
SEPTODONT INC
* SEPTODONT INC
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE,
PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE
SHASUN USA
* SHASUN USA INC
IBUPROFEN, IBUPROFEN
SHIONOGI INC
* SHIONOGI INC
ADRENACLICK, EPINEPHRINE
CUVPOSA, GLYCOPYRROLATE
FURADANTIN, NITROFURANTOIN
KAPVAY, CLONIDINE HYDROCHLORIDE
KEFLEX, CEPHALEXIN
MOXATAG, AMOXICILLIN
ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE
ORAPRED, PREDNISOLONE SODIUM PHOSPHATE
PONSTEL, MEFENAMIC ACID
ROBINUL FORTE, GLYCOPYRROLATE
ROBINUL, GLYCOPYRROLATE
SULAR, NISOLDIPINE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TWINJECT 0.15, EPINEPHRINE
TWINJECT 0.3, EPINEPHRINE

ULESFIA, BENZYL ALCOHOL

EPINEPHRINE BITARTRATE

B - 120

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

SHIRE
* SHIRE DEVELOPMENT INC
ADDERALL XR 10, AMPHETAMINE ASPARTATE
ADDERALL XR 15, AMPHETAMINE ASPARTATE
ADDERALL XR 20, AMPHETAMINE ASPARTATE
ADDERALL XR 25, AMPHETAMINE ASPARTATE
ADDERALL XR 30, AMPHETAMINE ASPARTATE
ADDERALL XR 5, AMPHETAMINE ASPARTATE
AGRYLIN, ANAGRELIDE HYDROCHLORIDE
CARBATROL, CARBAMAZEPINE
FOSRENOL, LANTHANUM CARBONATE
INTUNIV, GUANFACINE HYDROCHLORIDE
LIALDA, MESALAMINE
PENTASA, MESALAMINE
PROAMATINE, MIDODRINE HYDROCHLORIDE

SALURON, HYDROFLUMETHIAZIDE

SHIRE DEVELOPMENT
* SHIRE DEVELOPMENT INC
VYVANSE, LISDEXAMFETAMINE DIMESYLATE
SHIRE HUMAN GENETIC
* SHIRE HUMAN GENETIC THERAPIES INC
VPRIV, VELAGLUCERASE ALFA
SHIRE ORPHAN THERAP
* SHIRE ORPHAN THERAPIES INC
FIRAZYR, ICATIBANT ACETATE
SIGMA TAU
* SIGMA TAU PHARMACEUTICALS INC
ABELCET, AMPHOTERICIN B
ADAGEN, PEGADEMASE BOVINE
CARNITOR SF, LEVOCARNITINE
CARNITOR, LEVOCARNITINE

MATULANE, PROCARBAZINE HYDROCHLORIDE

SIGMAPHARM LABS LLC

* SIGMAPHARM LABORATORIES LLC
AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE
DISULFIRAM, DISULFIRAM
ERGOCALCIFEROL, ERGOCALCIFEROL
FLUCYTOSINE, FLUCYTOSINE

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

SILARX
* SILARX PHARMACEUTICALS INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL LACTATE
LEVETIRACETAM, LEVETIRACETAM
LORATADINE, LORATADINE (OTC)
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

SKINMEDICA
* SKINMEDICA INC
VANIQA, EFLORNITHINE HYDROCHLORIDE

B - 121

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

SKYEPHARMA AG
* SKYEPHARMA AG
TRIGLIDE, FENOFIBRATE
SLATE PHARMS
* SLATE PHARMACEUTICALS INC
TESTOPEL, TESTOSTERONE
SMITHKLINE BEECHAM
* SMITHKLINE BEECHAM
LOVAZA, OMEGA-3-ACID ETHYL ESTERS
* SMITHKLINE BEECHAM CORP
LAMICTAL XR, LAMOTRIGINE
* SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
ARRANON, NELARABINE
AXID, NIZATIDINE
COREG, CARVEDILOL
HYCAMTIN, TOPOTECAN HYDROCHLORIDE
LAMICTAL ODT, LAMOTRIGINE
REQUIP XL, ROPINIROLE HYDROCHLORIDE

TYKERB, LAPATINIB DITOSYLATE

SOAPCO
* SOAPCO INC
BRIAN CARE,

CHLORHEXIDINE GLUCONATE

(OTC)

SOLCO HLTHCARE
* SOLCO HEALTHCARE US LLC
LEVETIRACETAM, LEVETIRACETAM
SOMAXON
* SOMAXON PHARMACEUTICALS INC
SILENOR, DOXEPIN HYDROCHLORIDE
SOMERSET
* SOMERSET PHARMACEUTICALS INC
ELDEPRYL, SELEGILINE HYDROCHLORIDE

EMSAM, SELEGILINE

SPEAR PHARMS
* SPEAR PHARMACEUTICALS INC
FLUOROURACIL, FLUOROURACIL

TRETINOIN, TRETINOIN

SPECTRUM PHARMS
* SPECTRUM PHARMACEUTICALS
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
* SPECTRUM PHARMACEUTICALS INC
FUSILEV, LEVOLEUCOVORIN CALCIUM
STAND HOMEOPATH
* STANDARD HOMEOPATHIC CO
IVY BLOCK, BENTOQUATAM

(OTC)

STASON
* STASON INDUSTRIAL CORP
ACYCLOVIR, ACYCLOVIR
CAPTOPRIL, CAPTOPRIL

SELEGILINE HYDROCHLORIDE,

SELEGILINE HYDROCHLORIDE

STASON PHARMS
* STASON PHARMACEUTICALS INC
CYPROHEPTADINE HYDROCHLORIDE,

CYPROHEPTADINE HYDROCHLORIDE

STAT TRADE
* STAT TRADE INC
NAPRELAN, NAPROXEN SODIUM
STERI PHARMA
* STERI PHARMA LLC
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

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PRODUCT NAME SORTED BY APPLICANT

**

* STERI PHARMA LLC

CEFUROXIME SODIUM,

**

CEFUROXIME SODIUM

STEVENS J
* JEROME STEVENS PHARMACEUTICALS INC
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN
CEPHALEXIN, CEPHALEXIN
DIGOXIN, DIGOXIN
METHOCARBAMOL AND ASPIRIN, ASPIRIN
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN

UNITHROID, LEVOTHYROXINE SODIUM

STI PHARMA LLC

* STI PHARMA LLC
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
DEXAMETHASONE, DEXAMETHASONE
MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE

TRIACIN-C, CODEINE PHOSPHATE

STIEFEL
* STIEFEL LABORATORIES INC
DUAC, BENZOYL PEROXIDE
STIEFEL GSK
* STIEFEL A GSK CO
VELTIN, CLINDAMYCIN PHOSPHATE
STIEFEL LABS INC
* STIEFEL LABORATORIES INC
EVOCLIN, CLINDAMYCIN PHOSPHATE
EXTINA, KETOCONAZOLE
OLUX E, CLOBETASOL PROPIONATE
OLUX, CLOBETASOL PROPIONATE
ONMEL, ITRACONAZOLE
SORIATANE, ACITRETIN
SORILUX, CALCIPOTRIENE
VERDESO, DESONIDE

VUSION, MICONAZOLE NITRATE

STRIDES ARCOLAB
* STRIDES ARCOLAB LIMITED
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
STRIDES ARCOLAB LTD
* STRIDES ARCOLAB LTD
ACARBOSE, ACARBOSE
ADENOSINE, ADENOSINE
ERGOCALCIFEROL, ERGOCALCIFEROL
ETOMIDATE, ETOMIDATE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
MELOXICAM, MELOXICAM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

SUCAMPO PHARMS
* SUCAMPO PHARMACEUTICALS INC
AMITIZA, LUBIPROSTONE
SUMMERS
* SUMMERS LABORATORIES INC
CROTAN, CROTAMITON
SUN PHARM INDS
* SUN PHARMACEUTICAL INDUSTRIES LTD
CARBIDOPA AND LEVODOPA, CARBIDOPA
DESLORATADINE, DESLORATADINE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* SUN PHARMACEUTICAL INDUSTRIES LTD

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
ONDANSETRON, ONDANSETRON
OXCARBAZEPINE, OXCARBAZEPINE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE

TORSEMIDE, TORSEMIDE

SUN PHARM INDS (IN)

* SUN PHARMACEUTICAL INDUSTRIES LTD
CEPHALEXIN, CEPHALEXIN
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ORTHO-EST, ESTROPIPATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

SUN PHARM INDS INC

* SUN PHARMACEUTICAL INDUSTRIES INC
BENZONATATE, BENZONATATE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ERGOCALCIFEROL, ERGOCALCIFEROL
GEMFIBROZIL, GEMFIBROZIL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LITHIUM CARBONATE, LITHIUM CARBONATE
NIMODIPINE, NIMODIPINE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
VALPROIC ACID, VALPROIC ACID

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

SUN PHARM INDS LTD

* SUN PHARMACEUTICAL INDUSTRIES LTD
CARISOPRODOL, CARISOPRODOL
GABAPENTIN, GABAPENTIN
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
NARATRIPTAN, NARATRIPTAN
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

* SUN PHARMACEUTICAL INDUSTRIES LTD.

ANASTROZOLE, ANASTROZOLE
SUN PHARMA GLOBAL
* SUN PHARMA GLOBAL FZE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CAFFEINE CITRATE, CAFFEINE CITRATE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DOCEFREZ, DOCETAXEL
FINASTERIDE, FINASTERIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** S

**

* SUN PHARMA GLOBAL FZE

OXALIPLATIN, OXALIPLATIN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

* SUN PHARMA GLOBAL INC

ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALPRAZOLAM, ALPRAZOLAM
AMIFOSTINE, AMIFOSTINE
ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BICALUTAMIDE, BICALUTAMIDE
CARBOPLATIN, CARBOPLATIN
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

VECURONIUM BROMIDE, VECURONIUM BROMIDE

SUNOVION
* SUNOVION PHARMACEUTICALS INC
BROVANA, ARFORMOTEROL TARTRATE
LATUDA, LURASIDONE HYDROCHLORIDE
XOPENEX HFA, LEVALBUTEROL TARTRATE

XOPENEX, LEVALBUTEROL HYDROCHLORIDE

SUNOVION PHARMS INC

* SUNOVION PHARMACEUTICALS INC
LUNESTA, ESZOPICLONE
SVADS HOLDINGS SA
* SVADS HOLDINGS SA
IBUPROFEN, IBUPROFEN (OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

SVC PHARMA
* SVC PHARMA LP
DRONABINOL,

(OTC)

DRONABINOL

SYNCOR PHARMS
* SYNCOR PHARMACEUTICALS INC
SODIUM IODIDE I 123, SODIUM IODIDE I-123
SYNERX
* SYNERX PHARMA LLC
ISOSULFAN BLUE, ISOSULFAN BLUE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

SYNERX PHARMA
* SYNERX PHARMA LLC
CICLOPIROX, CICLOPIROX
FOMEPIZOLE, FOMEPIZOLE
MALATHION, MALATHION
TESTOSTERONE CYPIONATE,
TESTOSTERONE ENANTHATE,

TESTOSTERONE CYPIONATE

TESTOSTERONE ENANTHATE

SYNTHON PHARMS
* SYNTHON PHARMACEUTICALS INC
BICALUTAMIDE, BICALUTAMIDE
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

TAKEDA GLOBAL
* TAKEDA GLOBAL RESEARCH DEVELOPMENT CENTER INC
ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TAKEDA GLOBAL RESEARCH DEVELOPMENT CENTER INC

ACTOPLUS MET, METFORMIN HYDROCHLORIDE
DUETACT, GLIMEPIRIDE

ROZEREM, RAMELTEON

TAKEDA PHARMS
* TAKEDA PHARMACEUTICALS NORTH AMERICA INC
DEXILANT, DEXLANSOPRAZOLE
EDARBI, AZILSARTAN KAMEDOXOMIL
EDARBYCLOR, AZILSARTAN KAMEDOXOMIL

ULORIC, FEBUXOSTAT

TAKEDA PHARMS NA
* TAKEDA PHARMACEUTICALS NORTH AMERICA INC
ACTOS, PIOGLITAZONE HYDROCHLORIDE
PREVACID, LANSOPRAZOLE

PREVPAC, AMOXICILLIN

TARO
* TARO PHARMACEUTICAL INDUSTRIES LTD
ACETAZOLAMIDE, ACETAZOLAMIDE
CARBAMAZEPINE, CARBAMAZEPINE
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
ETODOLAC, ETODOLAC
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FLUCONAZOLE, FLUCONAZOLE
FLUOROURACIL, FLUOROURACIL
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
IMIQUIMOD, IMIQUIMOD
KETOCONAZOLE, KETOCONAZOLE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LORATADINE, LORATADINE (OTC)
MELOXICAM, MELOXICAM
MEPROBAMATE, MEPROBAMATE
METRONIDAZOLE, METRONIDAZOLE
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE

PHENYTOIN, PHENYTOIN

* TARO PHARMACEUTICALS INC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)
DESOXIMETASONE, DESOXIMETASONE
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE, FLUOCINONIDE
HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

WARFARIN SODIUM, WARFARIN SODIUM

* TARO PHARMACEUTICALS USA INC

ACETIC ACID, ACETIC ACID, GLACIAL
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMMONIUM LACTATE, AMMONIUM LACTATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T

**

* TARO PHARMACEUTICALS USA INC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CICLOPIROX, CICLOPIROX
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
DERMABET, BETAMETHASONE VALERATE
DESONIDE, DESONIDE
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
ECONAZOLE NITRATE, ECONAZOLE NITRATE
FLO-PRED, PREDNISOLONE ACETATE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUOROURACIL, FLUOROURACIL
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL
HYDROCORTISONE, HYDROCORTISONE
KETOZOLE, KETOCONAZOLE
LIDOCAINE, LIDOCAINE
LORATADINE, LORATADINE (OTC)
MICONAZOLE 3, MICONAZOLE NITRATE (OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPIROCIN, MUPIROCIN
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
NYSTATIN, NYSTATIN
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC)
TERCONAZOLE, TERCONAZOLE
TERIL, CARBAMAZEPINE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)

U-CORT, HYDROCORTISONE ACETATE

* TARO PHARMACEUTICALS, INC.

DESOXIMETASONE, DESOXIMETASONE
TARO PHARM INDS
* TARO PHARMACEUTICAL INDUSTRIES LTD
AMCINONIDE, AMCINONIDE
CARBAMAZEPINE, CARBAMAZEPINE
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ETODOLAC, ETODOLAC
FLUCONAZOLE, FLUCONAZOLE
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

LAMOTRIGINE, LAMOTRIGINE

TARO PHARMS IRELAND

* TARO PHARMACEUTICALS IRELAND LTD
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
TARO PHARMS NORTH
* TARO PHARMACEUTICALS NORTH AMERICA INC
OVIDE, MALATHION

TOPICORT LP, DESOXIMETASONE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TARO PHARMACEUTICALS NORTH AMERICA INC

TOPICORT, DESOXIMETASONE
TAYLOR
* TAYLOR PHARMACEUTICALS
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LORAZEPAM, LORAZEPAM
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE

TAYLOR PHARMA
* TAYLOR PHARMACAL CO
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TEDOR PHARM
* TEDOR PHARMA INC
BENZPHETAMINE HYDROCHLORIDE,

BENZPHETAMINE HYDROCHLORIDE

TEIKOKU PHARMA USA

* TEIKOKU PHARMA USA INC
LIDODERM, LIDOCAINE
TERCICA
* TERCICA INC
INCRELEX,

MECASERMIN RECOMBINANT

TEVA
* TEVA NEUROSCIENCE INC
AZILECT, RASAGILINE MESYLATE

COPAXONE, GLATIRAMER ACETATE

* TEVA PHARMACEUTICALS USA INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACYCLOVIR, ACYCLOVIR
ADIPEX-P, PHENTERMINE HYDROCHLORIDE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN PEDIATRIC, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
ATENOLOL, ATENOLOL
AZITHROMYCIN, AZITHROMYCIN
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETA-VAL, BETAMETHASONE VALERATE
BICALUTAMIDE, BICALUTAMIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CALCITRIOL, CALCITRIOL
CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL
CAPTOPRIL, CAPTOPRIL
CARBIDOPA AND LEVODOPA, CARBIDOPA
CARVEDILOL, CARVEDILOL
CEFACLOR, CEFACLOR
CEFPROZIL, CEFPROZIL
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEFUROXIME SODIUM, CEFUROXIME SODIUM
CEPHALEXIN, CEPHALEXIN
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CILOSTAZOL, CILOSTAZOL
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CIMETIDINE, CIMETIDINE
CLARITHROMYCIN, CLARITHROMYCIN

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TEVA PHARMACEUTICALS USA INC

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
CLOTRIMAZOLE, CLOTRIMAZOLE
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM
DIFLUNISAL, DIFLUNISAL
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
EPITOL, CARBAMAZEPINE
ESTAZOLAM, ESTAZOLAM
ETODOLAC, ETODOLAC
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLURBIPROFEN, FLURBIPROFEN
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GALZIN, ZINC ACETATE
GEMFIBROZIL, GEMFIBROZIL
GLIMEPIRIDE, GLIMEPIRIDE
GLYBURIDE (MICRONIZED), GLYBURIDE
GLYBURIDE, GLYBURIDE
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
KETOCONAZOLE, KETOCONAZOLE
KETOPROFEN, KETOPROFEN
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LAMOTRIGINE, LAMOTRIGINE
LEVOFLOXACIN, LEVOFLOXACIN
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE
LORATADINE, LORATADINE (OTC)
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOVASTATIN, LOVASTATIN
MESALAMINE, MESALAMINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOLAZONE, METOLAZONE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE, METRONIDAZOLE
MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MUPIROCIN, MUPIROCIN
NABUMETONE, NABUMETONE
NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN, NAPROXEN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T

**

* TEVA PHARMACEUTICALS USA INC

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE
NEOMYCIN SULFATE, NEOMYCIN SULFATE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NIZATIDINE, NIZATIDINE
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
NYSTATIN, NYSTATIN
OFLOXACIN, OFLOXACIN
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
ORAP, PIMOZIDE
OXAPROZIN, OXAPROZIN
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PENICILLIN-VK, PENICILLIN V POTASSIUM
PIROXICAM, PIROXICAM
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PRELONE, PREDNISOLONE
PURINETHOL, MERCAPTOPURINE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RIBAVIRIN, RIBAVIRIN
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SUCRALFATE, SUCRALFATE
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOLMETIN SODIUM, TOLMETIN SODIUM
TOPIRAMATE, TOPIRAMATE
TORSEMIDE, TORSEMIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRIACET, TRIAMCINOLONE ACETONIDE
TRIMETHOPRIM, TRIMETHOPRIM
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

TEVA BRANDED PHARM

* TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
* TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D INC
QVAR 40, BECLOMETHASONE DIPROPIONATE

QVAR 80, BECLOMETHASONE DIPROPIONATE

TEVA GLOBAL
* TEVA GLOBAL RESPIRATORY RESEARCH LLC
PROAIR HFA, ALBUTEROL SULFATE

PROGLYCEM, DIAZOXIDE

TEVA PARENTERAL
* TEVA PARENTERAL MEDICINES INC
ADENOSINE, ADENOSINE
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALPROSTADIL, ALPROSTADIL
AMIKACIN SULFATE, AMIKACIN SULFATE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AZITHROMYCIN, AZITHROMYCIN

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

B - 130

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TEVA PARENTERAL MEDICINES INC

BUDESONIDE, BUDESONIDE
CALCITRIOL, CALCITRIOL
CARBOPLATIN, CARBOPLATIN
CEFTRIAXONE, CEFTRIAXONE SODIUM
CIPROFLOXACIN, CIPROFLOXACIN
CISPLATIN, CISPLATIN
CROMOLYN SODIUM, CROMOLYN SODIUM
CYTOSAR-U, CYTARABINE
DACARBAZINE, DACARBAZINE
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
ENALAPRILAT, ENALAPRILAT
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM
ETOPOSIDE, ETOPOSIDE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUMAZENIL, FLUMAZENIL
FLUOROURACIL, FLUOROURACIL
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE
IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
IFOSFAMIDE, IFOSFAMIDE
IFOSFAMIDE/MESNA KIT, IFOSFAMIDE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE
LEVOCARNITINE, LEVOCARNITINE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MESNA, MESNA
METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE
METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
OXALIPLATIN, OXALIPLATIN
OXYTOCIN, OXYTOCIN
PACLITAXEL, PACLITAXEL
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PANCURONIUM BROMIDE, PANCURONIUM BROMIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPOFOL, PROPOFOL
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE

ZANOSAR, STREPTOZOCIN

B - 131

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APPENDIX B

B - 132

PRODUCT NAME SORTED BY APPLICANT

**

TEVA PARNTL
* TEVA PARENTAL MEDICINE INC
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE,

**

DORZOLAMIDE HYDROCHLORIDE

TEVA PHARMS
* TEVA PHARMACEUTICALS USA
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALPRAZOLAM, ALPRAZOLAM
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE
AZITHROMYCIN, AZITHROMYCIN
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFPROZIL, CEFPROZIL
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CICLOPIROX, CICLOPIROX
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
ASPARTATE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
ETHOSUXIMIDE, ETHOSUXIMIDE
FAMCICLOVIR, FAMCICLOVIR
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL LACTATE
HYDROCORTISONE, HYDROCORTISONE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LANSOPRAZOLE, LANSOPRAZOLE
LEFLUNOMIDE, LEFLUNOMIDE
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MEBENDAZOLE, MEBENDAZOLE
MEGESTROL ACETATE, MEGESTROL ACETATE
MELOXICAM, MELOXICAM
METHAZOLAMIDE, METHAZOLAMIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NATEGLINIDE, NATEGLINIDE
OLANZAPINE, OLANZAPINE
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE
QUINIDINE SULFATE, QUINIDINE SULFATE
RAMIPRIL, RAMIPRIL

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** T

**

* TEVA PHARMACEUTICALS USA

RISEDRONATE SODIUM, RISEDRONATE SODIUM
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TRANDOLAPRIL, TRANDOLAPRIL
URSODIOL, URSODIOL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALPROIC ACID, VALPROIC ACID
VANDAZOLE, METRONIDAZOLE

ZALEPLON, ZALEPLON

TEVA PHARMS USA

* TEVA PHARMACEUTICALS USA INC
IMIQUIMOD, IMIQUIMOD
TEVA WOMENS
* TEVA WOMENS HEALTH INC
CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A
ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B
LOSEASONIQUE, ETHINYL ESTRADIOL
MIRCETTE, DESOGESTREL
PLAN B, LEVONORGESTREL
PLAN B, LEVONORGESTREL (OTC)
PREFEST, ESTRADIOL
SEASONIQUE, ETHINYL ESTRADIOL

SYNTHETIC CONJUGATED ESTROGENS A, ESTROGENS, CONJUGATED SYNTHETIC A

THE PHARMA NETWORK

* THE PHARMA NETWORK LLC
BENZONATATE, BENZONATATE
THE PHARMANETWORK
* THE PHARMANETWORK LLC
METHADONE HYDROCHLORIDE,

METHADONE HYDROCHLORIDE

THERAKOS
* THERAKOS INC
UVADEX, METHOXSALEN
THERATECHNOLOGIES
* THERATECHNOLOGIES INC
EGRIFTA, TESAMORELIN ACETATE
THERAVANCE INC
* THERAVANCE INC
VIBATIV, TELAVANCIN HYDROCHLORIDE
THREE RIVERS PHARMS
* THREE RIVERS PHARMACEUTICALS LLC
ANASTROZOLE, ANASTROZOLE
RIBASPHERE, RIBAVIRIN
RIBAVIRIN, RIBAVIRIN

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

TIBOTEC
* TIBOTEC INC
EDURANT, RILPIVIRINE HYDROCHLORIDE
INTELENCE, ETRAVIRINE

PREZISTA, DARUNAVIR ETHANOLATE

TOLMAR
* TOLMAR INC
ATRIDOX, DOXYCYCLINE HYCLATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CALCIPOTRIENE, CALCIPOTRIENE
CICLOPIROX, CICLOPIROX
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

IMIQUIMOD, IMIQUIMOD

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* TOLMAR INC
KETOCONAZOLE, KETOCONAZOLE
LEVETIRACETAM, LEVETIRACETAM
LIDOCAINE AND PRILOCAINE, LIDOCAINE
METRONIDAZOLE, METRONIDAZOLE
MOMETASONE FUROATE, MOMETASONE FUROATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

TOLMAR THERAP
* TOLMAR THERAPEUTICS INC
ELIGARD, LEUPROLIDE ACETATE
TOPOTARGET
* TOPOTARGET AS
TOTECT, DEXRAZOXANE HYDROCHLORIDE
TORPHARM
* TORPHARM INC
RANITIDINE HYDROCHLORIDE,
TORRENT PHARM
* TORRENT PHARMA INC
METFORMIN HYDROCHLORIDE,

RANITIDINE HYDROCHLORIDE

(OTC)

METFORMIN HYDROCHLORIDE

TORRENT PHARMS
* TORRENT PHARMACEUTICALS LIMITED
LEVOFLOXACIN, LEVOFLOXACIN
* TORRENT PHARMACEUTICALS LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CARBAMAZEPINE, CARBAMAZEPINE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* TORRENT PHARMACEUTICALS LTD.

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
TORRENT PHARMS LLC
* TORRENT PHARMACEUTICALS LLC
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
OLANZAPINE, OLANZAPINE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

TORRENT PHARMS LTD

* TORRENT PHARMACEUTICALS LTD
FELODIPINE, FELODIPINE
TRIAX PHARMS LLC
* TRIAX PHARMACEUTICALS LLC
LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE
LOCOID, HYDROCORTISONE BUTYRATE
MINOCIN, MINOCYCLINE HYDROCHLORIDE

TRETINOIN, TRETINOIN

TRIS PHARMA INC

* TRIS PHARMA INC
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX,
IBUPROFEN, IBUPROFEN (OTC)

LEVETIRACETAM, LEVETIRACETAM

CHLORPHENIRAMINE POLISTIREX

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

* TRIS PHARMA INC

METHYLPHENIDATE HYDROCHLORIDE,

**

METHYLPHENIDATE HYDROCHLORIDE

UCB INC
* UCB INC
CO-GESIC, ACETAMINOPHEN
KEPPRA XR, LEVETIRACETAM
KEPPRA, LEVETIRACETAM
LORTAB, ACETAMINOPHEN
METADATE CD, METHYLPHENIDATE HYDROCHLORIDE
METADATE ER, METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MONOKET, ISOSORBIDE MONONITRATE
PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE
SEMPREX-D, ACRIVASTINE
THEO-24, THEOPHYLLINE
TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX
UNIRETIC, HYDROCHLOROTHIAZIDE
UNIVASC, MOEXIPRIL HYDROCHLORIDE
VIMPAT, LACOSAMIDE
XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE

ZAROXOLYN, METOLAZONE

UCYCLYD
* UCYCLYD PHARMA INC
AMMONUL, SODIUM BENZOATE
UDL LABS
* UDL LABORATORIES
SULFAMYLON, MAFENIDE ACETATE
ULURU
* ULURU INC
APHTHASOL,

AMLEXANOX

UNICHEM
* UNICHEM LABORATORIES LTD
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MELOXICAM, MELOXICAM
TOPIRAMATE, TOPIRAMATE

ZALEPLON, ZALEPLON

UNICHEM LABS LTD

* UNICHEM LABORATORIES LIMITED
DIVALPROEX SODIUM, DIVALPROEX SODIUM
* UNICHEM LABORATORIES LTD
LAMOTRIGINE, LAMOTRIGINE
UNICHEM PHARMS (USA)
* UNICHEM PHARMACEUTICALS (USA) INC
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
UNIQUE PHARM LABS
* UNIQUE PHARMACEUTICAL LABORATORIES
ATENOLOL, ATENOLOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM

FLUCONAZOLE, FLUCONAZOLE

UNITED GUARDIAN
* UNITED GUARDIAN INC
RENACIDIN, CITRIC ACID

B - 135

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

UNITED THERAP
* UNITED THERAPEUTICS CORP
REMODULIN, TREPROSTINIL SODIUM

TYVASO, TREPROSTINIL SODIUM

UPSHER SMITH
* UPSHER SMITH LABORATORIES INC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DIVIGEL, ESTRADIOL
FORTICAL, CALCITONIN SALMON RECOMBINANT
KLOR-CON M10, POTASSIUM CHLORIDE
KLOR-CON M15, POTASSIUM CHLORIDE
KLOR-CON M20, POTASSIUM CHLORIDE
LAMOTRIGINE, LAMOTRIGINE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
NIACOR, NIACIN
NYSTATIN, NYSTATIN
ORVATEN, MIDODRINE HYDROCHLORIDE
OXANDROLONE, OXANDROLONE
PACERONE, AMIODARONE HYDROCHLORIDE
PENTOXIL, PENTOXIFYLLINE
PREVALITE, CHOLESTYRAMINE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
SORINE, SOTALOL HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE

ZALEPLON, ZALEPLON

UPSHER-SMITH LABS
* UPSHER-SMITH LABORATORIES INC
KLOR-CON, POTASSIUM CHLORIDE
US WORLDMEDS
* US WORLDMEDS LLC
APOKYN, APOMORPHINE HYDROCHLORIDE

DANTROLENE SODIUM, DANTROLENE SODIUM

USL PHARMA
* USL PHARMA INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
BACLOFEN, BACLOFEN
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE
ESTRADIOL, ESTRADIOL
FLUOXYMESTERONE, FLUOXYMESTERONE
JANTOVEN, WARFARIN SODIUM
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

VALEANT
* VALEANT PHARMACEUTICALS INTERNATIONAL
ANCOBON, FLUCYTOSINE
BONTRIL PDM, PHENDIMETRAZINE TARTRATE
BONTRIL, PHENDIMETRAZINE TARTRATE

CAPITAL AND CODEINE, ACETAMINOPHEN

D.H.E. 45, DIHYDROERGOTAMINE MESYLATE

DIASTAT ACUDIAL, DIAZEPAM

DIASTAT, DIAZEPAM

MIGRANAL, DIHYDROERGOTAMINE MESYLATE

MOTOFEN, ATROPINE SULFATE

MYSOLINE, PRIMIDONE

PHRENILIN FORTE, ACETAMINOPHEN

PHRENILIN WITH CAFFEINE AND CODEINE, ACETAMINOPHEN

PHRENILIN, ACETAMINOPHEN

B - 136

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

VALEANT INTL
* VALEANT INTERNATIONAL BARBADOS SRL
ATIVAN, LORAZEPAM
CARDIZEM CD, DILTIAZEM HYDROCHLORIDE
CARDIZEM LA, DILTIAZEM HYDROCHLORIDE
CARDIZEM, DILTIAZEM HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
ELIDEL, PIMECROLIMUS
ISORDIL, ISOSORBIDE DINITRATE
NIFEDIPINE, NIFEDIPINE
PENTOXIFYLLINE, PENTOXIFYLLINE
TIAZAC, DILTIAZEM HYDROCHLORIDE
ULTRAM ER, TRAMADOL HYDROCHLORIDE
VASERETIC, ENALAPRIL MALEATE
VASOTEC, ENALAPRIL MALEATE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
WELLBUTRIN XL, BUPROPION HYDROCHLORIDE
XERESE, ACYCLOVIR

ZOVIRAX, ACYCLOVIR

* VALEANT INTERNATIONAL SRL

APLENZIN, BUPROPION HYDROBROMIDE
RETIN-A MICRO, TRETINOIN

XENAZINE, TETRABENAZINE

VALEANT PHARM INTL

* VALEANT PHARMACEUTICALS INTERNATIONAL
8-MOP, METHOXSALEN
ANDROID 10, METHYLTESTOSTERONE
ANDROID 25, METHYLTESTOSTERONE
EFUDEX, FLUOROURACIL
LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE
LIMBITROL DS, AMITRIPTYLINE HYDROCHLORIDE
LIMBITROL, AMITRIPTYLINE HYDROCHLORIDE
MESTINON, PYRIDOSTIGMINE BROMIDE
OXSORALEN, METHOXSALEN
OXSORALEN-ULTRA, METHOXSALEN
TASMAR, TOLCAPONE
TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE
TENSILON, EDROPHONIUM CHLORIDE
TESTRED, METHYLTESTOSTERONE
VIRAZOLE, RIBAVIRIN

ZELAPAR, SELEGILINE HYDROCHLORIDE

VALEANT PHARMS
* VALEANT PHARMACEUTICALS NORTH AMERICA
POTIGA, EZOGABINE
VALIDUS PHARMS
* VALIDUS PHARMACEUTICALS LLC
ROCALTROL, CALCITRIOL
VALIDUS PHARMS INC
* VALIDUS PHARMACEUTICALS INC
EQUETRO, CARBAMAZEPINE

MARPLAN, ISOCARBOXAZID

VEROSCIENCE
* VEROSCIENCE LLC
CYCLOSET, BROMOCRIPTINE MESYLATE
VERSAPHARM
* VERSAPHARM INC
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DESOXIMETASONE, DESOXIMETASONE

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APPENDIX B

B - 138

PRODUCT NAME SORTED BY APPLICANT

**

**

* VERSAPHARM INC
ERYTHROMYCIN, ERYTHROMYCIN
ETHOSUXIMIDE, ETHOSUXIMIDE

RIFAMPIN, RIFAMPIN

VERSAPHARM INC
* VERSAPHARM INC
RIFAMPIN, RIFAMPIN
* VERSAPHARM INCORPORATED
TRANEXAMIC ACID, TRANEXAMIC ACID
VERTEX PHARMS
* VERTEX PHARMACEUTICALS INC
INCIVEK, TELAPREVIR
VICURON
* VICURON PHARMACEUTICALS INC
ERAXIS, ANIDULAFUNGIN
VIIV HLTHCARE
* VIIV HEALTHCARE CO
COMBIVIR, LAMIVUDINE
EPIVIR, LAMIVUDINE
EPZICOM, ABACAVIR SULFATE
LEXIVA, FOSAMPRENAVIR CALCIUM
RESCRIPTOR, DELAVIRDINE MESYLATE
RETROVIR, ZIDOVUDINE
SELZENTRY, MARAVIROC
TRIZIVIR, ABACAVIR SULFATE

ZIAGEN, ABACAVIR SULFATE

VINTAGE
* VINTAGE PHARMACEUTICALS LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACETIC ACID, ACETIC ACID, GLACIAL
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALPRAZOLAM, ALPRAZOLAM
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CYCLAFEM 1/35, ETHINYL ESTRADIOL
CYCLAFEM 7/7/7, ETHINYL ESTRADIOL
DIVALPROEX SODIUM, DIVALPROEX SODIUM
EMOQUETTE, DESOGESTREL
FOLIC ACID, FOLIC ACID
GILDESS FE 1.5/30, ETHINYL ESTRADIOL
GILDESS FE 1/20, ETHINYL ESTRADIOL
GLIMEPIRIDE, GLIMEPIRIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRISEOFULVIN, GRISEOFULVIN
HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL
HYDROCORTISONE, HYDROCORTISONE
LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LISINOPRIL, LISINOPRIL
NYSTATIN, NYSTATIN
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE, PREDNISOLONE
PREVIFEM, ETHINYL ESTRADIOL
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE

RISPERIDONE, RISPERIDONE

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* VINTAGE PHARMACEUTICALS LLC

SPIRONOLACTONE, SPIRONOLACTONE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TRI-PREVIFEM, ETHINYL ESTRADIOL
VALPROIC ACID, VALPROIC ACID
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

VINTAGE PHARMS
* VINTAGE PHARMACEUTICALS
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
ORSYTHIA, ETHINYL ESTRADIOL

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

* VINTAGE PHARMACEUTICALS INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ALLOPURINOL, ALLOPURINOL
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
BACLOFEN, BACLOFEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN
CARISOPRODOL, CARISOPRODOL
CLONAZEPAM, CLONAZEPAM
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DEXAMETHASONE, DEXAMETHASONE
DIAZEPAM, DIAZEPAM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
FUROSEMIDE, FUROSEMIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
HYDROCORTISONE, HYDROCORTISONE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LACTULOSE, LACTULOSE
LEVETIRACETAM, LEVETIRACETAM
LORAZEPAM, LORAZEPAM
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METHOCARBAMOL, METHOCARBAMOL
METHYLPREDNISOLONE, METHYLPREDNISOLONE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
NYSTATIN, NYSTATIN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PERPHENAZINE, PERPHENAZINE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PREDNISONE, PREDNISONE
PRIMIDONE, PRIMIDONE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SULFASALAZINE, SULFASALAZINE
TORSEMIDE, TORSEMIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

VIROPHARMA
* VIROPHARMA INC
VANCOCIN HYDROCHLORIDE,

VANCOMYCIN HYDROCHLORIDE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

VISTA PHARMS
* VISTA PHARMACEUTICALS INC
SULFAMETHOXAZOLE AND TRIMETHOPRIM,

**

SULFAMETHOXAZOLE

VISTAPHARM
* VISTAPHARM INC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
LACTULOSE, LACTULOSE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
NYSTATIN, NYSTATIN

PHENYTOIN, PHENYTOIN

WARNER CHILCOTT
* WARNER CHILCOTT BERMUDA LTD
CHOLEDYL SA, OXTRIPHYLLINE
* WARNER CHILCOTT CO LLC
ACTONEL, RISEDRONATE SODIUM

ATELVIA, RISEDRONATE SODIUM

* WARNER CHILCOTT INC

ERYC, ERYTHROMYCIN
ESTRACE, ESTRADIOL
ESTROSTEP FE, ETHINYL ESTRADIOL
FEMCON FE, ETHINYL ESTRADIOL
FEMHRT, ETHINYL ESTRADIOL
FEMTRACE, ESTRADIOL ACETATE
LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL
LOESTRIN 21 1/20, ETHINYL ESTRADIOL
LOESTRIN 24 FE, ETHINYL ESTRADIOL
LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL
LOESTRIN FE 1/20, ETHINYL ESTRADIOL
OVCON-35, ETHINYL ESTRADIOL
OVCON-50, ETHINYL ESTRADIOL

SARAFEM, FLUOXETINE HYDROCHLORIDE

WARNER CHILCOTT CO
* WARNER CHILCOTT CO INC
LO LOESTRIN FE, ETHINYL ESTRADIOL
WARNER CHILCOTT LLC
* WARNER CHILCOTT CO LLC
ASACOL HD, MESALAMINE
ASACOL, MESALAMINE

ENABLEX, DARIFENACIN HYDROBROMIDE

WATSON LABS
* WATSON LABORATORIES
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
ANASTROZOLE, ANASTROZOLE
CARBOPLATIN, CARBOPLATIN
CARVEDILOL, CARVEDILOL
FOLIC ACID, FOLIC ACID
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MICROGESTIN 1.5/30, ETHINYL ESTRADIOL
MICROGESTIN 1/20, ETHINYL ESTRADIOL
MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL
MICROGESTIN FE 1/20, ETHINYL ESTRADIOL
NORCO, ACETAMINOPHEN
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
OXAPROZIN, OXAPROZIN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

B - 140

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* WATSON LABORATORIES INC

ACARBOSE, ACARBOSE
ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE
ACETAZOLAMIDE, ACETAZOLAMIDE
ACETOHEXAMIDE, ACETOHEXAMIDE
ACYCLOVIR, ACYCLOVIR
AFEDITAB CR, NIFEDIPINE
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALLOPURINOL, ALLOPURINOL
ALORA, ESTRADIOL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXAPINE, AMOXAPINE
ANDRODERM, TESTOSTERONE
ATENOLOL AND CHLORTHALIDONE, ATENOLOL
ATENOLOL, ATENOLOL
BACLOFEN, BACLOFEN
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
BREVICON 28-DAY, ETHINYL ESTRADIOL
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN
CABERGOLINE, CABERGOLINE
CAPTOPRIL, CAPTOPRIL
CARBOPLATIN, CARBOPLATIN
CARISOPRODOL, CARISOPRODOL
CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORPROPAMIDE, CHLORPROPAMIDE
CHLORZOXAZONE, CHLORZOXAZONE
CICLOPIROX, CICLOPIROX
CIMETIDINE, CIMETIDINE
CIMETIDINE, CIMETIDINE (OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
COL-PROBENECID, COLCHICINE
CORDRAN, FLURANDRENOLIDE
CRINONE, PROGESTERONE
CROMOLYN SODIUM, CROMOLYN SODIUM
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOSPORINE, CYCLOSPORINE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
DIAZEPAM, DIAZEPAM
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DILACOR XR, DILTIAZEM HYDROCHLORIDE
DIMENHYDRINATE, DIMENHYDRINATE
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* WATSON LABORATORIES INC

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
ERGOLOID MESYLATES, ERGOLOID MESYLATES
ESTAZOLAM, ESTAZOLAM
ESTRADIOL CYPIONATE, ESTRADIOL CYPIONATE
ESTRADIOL VALERATE, ESTRADIOL VALERATE
ESTRADIOL, ESTRADIOL
ESTRONE, ESTRONE
ESTROPIPATE, ESTROPIPATE
FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
FENTANYL CITRATE, FENTANYL CITRATE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE
FLUTAMIDE, FLUTAMIDE
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
FUROSEMIDE, FUROSEMIDE
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GELNIQUE, OXYBUTYNIN CHLORIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GEMFIBROZIL, GEMFIBROZIL
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE, GLIPIZIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROXOCOBALAMIN, HYDROXOCOBALAMIN
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
INDAPAMIDE, INDAPAMIDE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
ISONIAZID, ISONIAZID
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
ISRADIPINE, ISRADIPINE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL (OTC)
LEVORA 0.15/30-28, ETHINYL ESTRADIOL
LISINOPRIL, LISINOPRIL
LORAZEPAM, LORAZEPAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOW-OGESTREL-21, ETHINYL ESTRADIOL
LOW-OGESTREL-28, ETHINYL ESTRADIOL
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM

B - 142

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* WATSON LABORATORIES INC

MELOXICAM, MELOXICAM
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
MEPROBAMATE, MEPROBAMATE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METHOCARBAMOL, METHOCARBAMOL
METHYCLOTHIAZIDE, METHYCLOTHIAZIDE
METHYLDOPA, METHYLDOPA
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
METHYLPREDNISOLONE, METHYLPREDNISOLONE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE, METRONIDAZOLE
MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE
MICROZIDE, HYDROCHLOROTHIAZIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MINOXIDIL, MINOXIDIL
MIRTAZAPINE, MIRTAZAPINE
MORPHINE SULFATE, MORPHINE SULFATE
NABUMETONE, NABUMETONE
NAPROXEN SODIUM, NAPROXEN SODIUM
NAPROXEN, NAPROXEN
NATEGLINIDE, NATEGLINIDE
NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
NIZATIDINE, NIZATIDINE
NORCO, ACETAMINOPHEN
NORETHIN 1/35E-21, ETHINYL ESTRADIOL
NORETHIN 1/35E-28, ETHINYL ESTRADIOL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14), ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL
NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL
NORINYL 1+50 28-DAY, MESTRANOL
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
OGESTREL 0.5/50-28, ETHINYL ESTRADIOL
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
OXAZEPAM, OXAZEPAM
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE AND ASPIRIN, ASPIRIN
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE
PENTAZOCINE AND NALOXONE HYDROCHLORIDES, NALOXONE HYDROCHLORIDE
PENTOXIFYLLINE, PENTOXIFYLLINE
PINDOLOL, PINDOLOL
PIROXICAM, PIROXICAM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PREDNISOLONE, PREDNISOLONE
PREDNISONE, PREDNISONE
PRIMIDONE, PRIMIDONE
PROBENECID, PROBENECID
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

QUASENSE, ETHINYL ESTRADIOL

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* WATSON LABORATORIES INC

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE
QUINIDINE SULFATE, QUINIDINE SULFATE
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RAPAFLO, SILODOSIN
RISPERIDONE, RISPERIDONE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
SULFASALAZINE, SULFASALAZINE
SULINDAC, SULINDAC
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TACROLIMUS, TACROLIMUS
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TEMAZEPAM, TEMAZEPAM
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE
THIOTHIXENE, THIOTHIXENE
TOLAZAMIDE, TOLAZAMIDE
TOLBUTAMIDE, TOLBUTAMIDE
TOPIRAMATE, TOPIRAMATE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRANDOLAPRIL, TRANDOLAPRIL
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRELSTAR, TRIPTORELIN PAMOATE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TRIAZOLAM, TRIAZOLAM
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
TRIMETHOPRIM, TRIMETHOPRIM
TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL
TRIVORA-28, ETHINYL ESTRADIOL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZOVIA 1/35E-28, ETHINYL ESTRADIOL

ZOVIA 1/50E-28, ETHINYL ESTRADIOL

* WATSON LABS INC

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
WATSON LABS (UTAH)
* WATSON LABORATORIES INC
INFED, IRON DEXTRAN
NOR-QD, NORETHINDRONE
OXYTROL, OXYBUTYNIN

PROGESTERONE, PROGESTERONE

WATSON LABS FLORIDA

* WATSON LABORATORIES INC FLORIDA
ALPRAZOLAM, ALPRAZOLAM
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARTIA XT, DILTIAZEM HYDROCHLORIDE
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CLARITHROMYCIN, CLARITHROMYCIN
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W

**

* WATSON LABORATORIES INC FLORIDA

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GLIMEPIRIDE, GLIMEPIRIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
KETOPROFEN, KETOPROFEN
LEVETIRACETAM, LEVETIRACETAM
LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)
LORATADINE, LORATADINE (OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MIRTAZAPINE, MIRTAZAPINE
OMEPRAZOLE, OMEPRAZOLE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TAZTIA XT, DILTIAZEM HYDROCHLORIDE

WATSON LABS INC

* WATSON LABORATORIES INC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
FIORICET W/ CODEINE, ACETAMINOPHEN
FIORINAL W/CODEINE, ASPIRIN
FIORINAL, ASPIRIN
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
URSODIOL, URSODIOL
WATSON PHARMS
* WATSON PHARMACEUTICALS
TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE

TENUATE, DIETHYLPROPION HYDROCHLORIDE

* WATSON PHARMACEUTICALS INC

ACTIGALL, URSODIOL
CONDYLOX, PODOFILOX
CORDRAN SP, FLURANDRENOLIDE
CORDRAN, FLURANDRENOLIDE
FIORICET, ACETAMINOPHEN

MONODOX, DOXYCYCLINE

WE PHARMS
* WE PHARMACEUTICALS INC
PREDNISOLONE SODIUM PHOSPHATE,

PREDNISOLONE SODIUM PHOSPHATE

WEILL MEDCL COLL

* WEILL MEDICAL COLLEGE CORNELL UNIV
FLUDEOXYGLUCOSE F 18, FLUDEOXYGLUCOSE F-18
WELLSPRING PHARM
* WELLSPRING PHARMACEUTICAL CORP
DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE
DUVOID, BETHANECHOL CHLORIDE

DYRENIUM, TRIAMTERENE

WEST WARD
* WEST WARD INC
ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

* WEST WARD PHARMACEUTICAL CORP

AMINOPHYLLINE, AMINOPHYLLINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE,
BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

CAPTOPRIL, CAPTOPRIL

ACETAMINOPHEN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W

**

* WEST WARD PHARMACEUTICAL CORP

CARISOPRODOL, CARISOPRODOL
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
CHLOROTHIAZIDE, CHLOROTHIAZIDE
CORTISONE ACETATE, CORTISONE ACETATE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DIGOXIN, DIGOXIN
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE
FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE
FOLIC ACID, FOLIC ACID
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROCORTISONE, HYDROCORTISONE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
ISONIAZID, ISONIAZID
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LITHIUM CARBONATE, LITHIUM CARBONATE
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
METHOCARBAMOL, METHOCARBAMOL
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PREDNISONE, PREDNISONE
PRIMIDONE, PRIMIDONE
PROPYLTHIOURACIL, PROPYLTHIOURACIL
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

ZALEPLON, ZALEPLON

WEST WARD PHARM CORP

* WEST WARD PHARMACEUTICAL CORP
PREDNISONE, PREDNISONE
WEST WARD PHARMS
* WEST WARD PHARMACEUTICALS CORP
RISPERIDONE, RISPERIDONE
WESTWARD
* WESTWARD PHARMACEUTICAL CORP
NAPROXEN, NAPROXEN

RIFAMPIN AND ISONIAZID, ISONIAZID

WEST-WARD PHARM CORP

* WEST-WARD PHARMACEUTICAL CORP
CEFOTETAN, CEFOTETAN DISODIUM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

WOCKHARDT
* WOCKHARDT AMERICAS INC
CAPTOPRIL, CAPTOPRIL
FAMOTIDINE, FAMOTIDINE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

* WOCKHARDT EU OPERATIONS (SWISS) AG

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACETIC ACID, ACETIC ACID, GLACIAL
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
BROMFED-DM, BROMPHENIRAMINE MALEATE
CARBAMAZEPINE, CARBAMAZEPINE
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* WOCKHARDT EU OPERATIONS (SWISS) AG

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CROMOLYN SODIUM, CROMOLYN SODIUM
CYCLOSPORINE, CYCLOSPORINE
DEXAMETHASONE, DEXAMETHASONE
DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
ERYTHROMYCIN, ERYTHROMYCIN
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
FUROSEMIDE, FUROSEMIDE
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LINDANE, LINDANE
LITHIUM CITRATE, LITHIUM CITRATE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LORATADINE, LORATADINE (OTC)
MEGESTROL ACETATE, MEGESTROL ACETATE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
NYSTATIN, NYSTATIN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PHENYTOIN, PHENYTOIN
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE, PREDNISOLONE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE
SELENIUM SULFIDE, SELENIUM SULFIDE
TRETINOIN, TRETINOIN
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VALPROIC ACID, VALPROIC ACID

* WOCKHARDT LTD
ADENOSINE, ADENOSINE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AZITHROMYCIN, AZITHROMYCIN
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
CARVEDILOL, CARVEDILOL
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFOTAXIME, CEFOTAXIME SODIUM
CEFPROZIL, CEFPROZIL
CEFTAZIDIME, CEFTAZIDIME
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CLARITHROMYCIN, CLARITHROMYCIN
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FAMOTIDINE, FAMOTIDINE (OTC)
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FUROSEMIDE, FUROSEMIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN

LISINOPRIL, LISINOPRIL

B - 147

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

** W

**

* WOCKHARDT LTD
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
NIACIN, NIACIN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TIMOLOL MALEATE, TIMOLOL MALEATE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

WOCKHARDT USA
* WOCKHARDT USA INC
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

* WOCKHARDT USA LLC

ENALAPRIL MALEATE, ENALAPRIL MALEATE

TOPIRAMATE, TOPIRAMATE

WORLD GEN
* WORLD GEN LLC
AMLODIPINE BESYLATE,

AMLODIPINE BESYLATE

WRASER PHARMS
* WRASER PHARMACEUTICALS LLC
CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE
WRASER PHARMS LLC
* WRASER PHARMACEUTICALS LLC
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE,
WYETH CONS
* WYETH CONSUMER HEALTHCARE
ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
ADVIL COLD AND SINUS, IBUPROFEN (OTC)
ADVIL CONGESTION RELIEF, IBUPROFEN (OTC)
ADVIL LIQUI-GELS, IBUPROFEN (OTC)
ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC)
ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
ADVIL, IBUPROFEN (OTC)
ALAVERT, LORATADINE (OTC)
AXID AR, NIZATIDINE (OTC)
CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE
CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)
CHILDREN'S ADVIL, IBUPROFEN (OTC)
CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC)
JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)
LORATADINE, LORATADINE (OTC)

PEDIATRIC ADVIL, IBUPROFEN (OTC)

WYETH PHARMS
* WYETH PHARMACEUTICALS INC SUB PFIZER INC
LO/OVRAL-28, ETHINYL ESTRADIOL

ACETAMINOPHEN

(OTC)

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

WYETH PHARMS INC

* WYETH PHARMACEUTICALS INC
CORDARONE, AMIODARONE HYDROCHLORIDE
EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE
LYBREL, ETHINYL ESTRADIOL
PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE
PREMARIN, ESTROGENS, CONJUGATED
PREMPHASE 14/14, ESTROGENS, CONJUGATED
PREMPRO, ESTROGENS, CONJUGATED
PRISTIQ, DESVENLAFAXINE SUCCINATE
PROTONIX IV, PANTOPRAZOLE SODIUM
PROTONIX, PANTOPRAZOLE SODIUM
RAPAMUNE, SIROLIMUS
TORISEL, TEMSIROLIMUS
TRECATOR, ETHIONAMIDE
TYGACIL, TIGECYCLINE
ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM

ZOSYN, PIPERACILLIN SODIUM

X GEN PHARMS
* X GEN PHARMACEUTICALS INC
ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM
AMPHOTERICIN B, AMPHOTERICIN B
BACIIM, BACITRACIN
BACI-RX, BACITRACIN
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE
HYDRO-RX, HYDROCORTISONE
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
NEO-FRADIN, NEOMYCIN SULFATE
NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE
NEOMYCIN SULFATE, NEOMYCIN SULFATE
NEO-RX, NEOMYCIN SULFATE
NYSTATIN, NYSTATIN
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
POLY-RX, POLYMYXIN B SULFATE
STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

XANODYNE PHARM
* XANODYNE PHARMACEUTICS INC
AMICAR, AMINOCAPROIC ACID
ORAMORPH SR, MORPHINE SULFATE

ZIPSOR, DICLOFENAC POTASSIUM

XANODYNE PHARMS
* XANODYNE PHARMACEUTICALS INC
ROXICODONE, OXYCODONE HYDROCHLORIDE
X-GEN PHARMS
* X-GEN PHARMACEUTICALS INC
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
PHENYTOIN SODIUM, PHENYTOIN SODIUM

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

XTTRIUM
* XTTRIUM LABORATORIES INC
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
DYNA-HEX, CHLORHEXIDINE GLUCONATE (OTC)

EXIDINE, CHLORHEXIDINE GLUCONATE (OTC)

YUNG SHIN PHARM

* YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
CEFACLOR, CEFACLOR

CEPHALEXIN, CEPHALEXIN

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APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

ZAMBON SPA
* ZAMBON SPA ITALY
MONUROL, FOSFOMYCIN TROMETHAMINE
ZARS PHARM
* ZARS PHARMA INC
SYNERA, LIDOCAINE
ZOGENIX INC
* ZOGENIX INC
SUMAVEL DOSEPRO,

SUMATRIPTAN SUCCINATE

ZYDUS PHARMS USA

* ZYDUS PHARMACEUTICALS USA INC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ATENOLOL, ATENOLOL
AZATHIOPRINE, AZATHIOPRINE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BENZONATATE, BENZONATATE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
MELOXICAM, MELOXICAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN, NAPROXEN
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RIBAVIRIN, RIBAVIRIN
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM

ZONISAMIDE, ZONISAMIDE

ZYDUS PHARMS USA INC

* ZYDUS PHARMACEUTICALS USA INC
ACETAZOLAMIDE, ACETAZOLAMIDE
ALPRAZOLAM, ALPRAZOLAM
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ANASTROZOLE, ANASTROZOLE
ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE
BICALUTAMIDE, BICALUTAMIDE
BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
CARVEDILOL, CARVEDILOL
DIPYRIDAMOLE, DIPYRIDAMOLE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
INDOMETHACIN, INDOMETHACIN
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL

RISPERIDONE, RISPERIDONE

B - 150

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

APPENDIX B

PRODUCT NAME SORTED BY APPLICANT

**

**

* ZYDUS PHARMACEUTICALS USA INC

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

B - 151

32ND EDITION - 2011 - APPROVED DRUG PRODUCTS LIST

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 SOLUTION, TABLET, 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
INJECTABLE
INJECTABLE, LIPID COMPLEX
INJECTABLE, LIPOSOMAL
INSERT
INSERT, EXTENDED RELEASE
INTRAUTERINE DEVICE
JELLY
LIQUID
LOTION
LOTION, AUGMENTED

Note: Terms comprise currently marketed products

LOTION/SHAMPOO
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, 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-1

32ND EDITION - 2011 - APPROVED DRUG PRODUCTS LIST

APPENDIX C
UNIFORM TERMS
ROUTES OF ADMINISTRATION
BUCCAL
DENTAL
ENDOCERVICAL
EPIDURAL
FOR RX COMPOUNDING
IM-IV
IM-IV-SC
IMPLANTATION
IM-SC
INHALATION
INJECTION
INTRA-ANAL
INTRA-ARTICULAR, INTRAMUSCULAR,
INTRAVITREAL
INTRACRANIAL
INTRAMUSCULAR
INTRAOCULAR
INTRAPERITONEAL
INTRAPLEURAL
INTRATHECAL
INTRATRACHEAL
INTRAUTERINE
INTRAVENOUS
INTRAVESICAL

Note: Terms comprise currently marketed products

INTRAVITREAL
IRRIGATION
IV (INFUSION)
IV (INFUSION)-SC
IV-SC
N/A
NASAL
OPHTHALMIC
ORAL
ORAL-21
ORAL-28
OTIC
PERFUSION, CARDIAC
PERIODONTAL
RECTAL
SPINAL
SUBCUTANEOUS
SUBLINGUAL
TOPICAL
TRANSDERMAL
TRANSMUCOSAL
URETHRAL
VAGINAL

C-2

32ND EDITION - 2011 - APPROVED DRUG PRODUCTS LIST

APPENDIX C

UNIFORM TERMS

ABBREVIATIONS

AMP
AMPICIL
APPROX
BOT
CI
CSR
CU
DIPROP
ELECT
EQ
ER
GM
HBR
HCL
HR
INH
IU
KIU
MCG
MCI
MEQ
MG
ML
N/A
PPM
REL
SQ CM
U
UCI
UMOLAR
USP

AMPULE
AMPICILLIN
APPROXIMATELY
BOTTLE
CURIE
CAROTID SINUS REFLEX
CLINICAL UNITS
DIPROPIONATE
ELECTROLYTE
EQUIVALENT TO
EXTENDED RELEASE
GRAM
HYDROBROMIDE
HYDROCHLORIDE
HOUR
INHALATION
INTERNATIONAL UNITS
KALLIKREIN INHIBITOR UNITS
MICROGRAM
MILLICURIE
MILLIEQUIVALENT
MILLIGRAM
MILLILITER
NOT APPLICABLE
PARTS PER MILLION
RELEASE
SQUARE CENTIMETER
UNITS
MICROCURIE
MICROMOLAR
UNITED STATES PHARMACOPEIA

C-3

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM

This Addendum identifies drugs that qualify under the Drug Price
Competition and Patent Term Restoration Act (1984 Amendments) for periods of
exclusivity, during which abbreviated new drug applications (ANDAs) and
applications described in Section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act (the Act) for those drug products may, in some instances, not be
submitted or made effective as described below, and provides patent
information concerning the listed drug products. Those drugs that have
qualified for Orphan Drug Exclusivity pursuant to Section 527 of the Act and
those drugs that have qualified for Pediatric Exclusivity pursuant to Section
505A are also included in this Addendum. This section is arranged in
alphabetical order by active ingredient name followed the trade name. Active
ingredient headings for multiple ingredient (combination) drug products are
arranged alphabetically. For an explanation of the codes used in the
Addendum, see the Patent and Exclusivity Terms Section. Exclusivity prevents
the submission or effective approval of ANDAs or applications described in
Section 505(b)(2) of the Act. It does not prevent the submission or approval
of a second 505(b)(1) application except in the case of Orphan Drug
exclusivity. Applications qualifying for periods of exclusivity are:
(1) A new drug application approved after September 24, 1984, for a drug
product all active ingredients (including any ester or salt of the
active ingredient) of which had never been approved in any other new
drug application under Section 505 (b) of the Act. No subsequent ANDA
or application described in Section 505(b)(2) of the Act for the same
drug may be submitted for a period of five years from the date of
approval of the original application, except that such an application
may be submitted after four years if it contains a certification that a
patent claiming the drug is invalid or will not be infringed by the
product for which approval is sought.
(2) A new drug application approved after September 24, 1984, for a drug
product containing an active ingredient (including any ester or salt of
that active ingredient) that has been approved in an earlier new drug
application and that includes reports of new clinical investigations
(other than bioavailability studies). Such investigations must have
been conducted or sponsored by the applicant and must have been
essential to approval of the application. If these requirements are
met, the approval of a subsequent ANDA or an application described in
Section 505(b)(2) of the Act may not be made effective for the same drug
or use, if for a new indication, before the expiration of three years
from the date of approval of the original application. If an applicant
has exclusivity for a new application or 505(b)(2) application for the
drug product with indications or use, this does not preclude the
approval of an ANDA or 505(b)(2) application not covered by the
exclusivity.
(3) A supplement to a new drug application for a drug containing a
previously approved active ingredient including (any ester or salt of
the active ingredient) approved after September 24, 1984, that contains
reports of new clinical investigations (other than bioavailability
studies) essential to the approval of the supplement and conducted or
sponsored by the applicant. The approval of a subsequent ANDA or
505(b)(2) application for a change approved in the supplement may not be

AD 1

made effective for three years from the date of approval of the original
supplement.

The Act requires that patent information be filed with all newly
submitted Section 505(b) drug applications. No NDA may be approved after
September 24, 1984, without the submission of patent information to the
Agency. Effective August 18, 2003, this information must be filed using FDA
Form 3524a Patent Information Submitted with the Filing of an NDA, Amendment
or Supplement.
Effective August 18, 2003, upon approval of an application, patent
information for purposes of listing in the Orange Book must be submitted to
the agency within 30 days of approval on FDA Form 3542 Patent Information
Submitted Upon and After Approval of an NDA or Supplement. Patent
information on unapproved applications or on patents beyond the scope of the
Act (i.e., process or manufacturing patents) will not be published. FDA form
3542 will be the only form used for the purposes of this publication.
The patents that FDA regards as covered by the statutory provisions for
submission of patent information are: patents that claim the active
ingredient(s); drug product patents which include formulation/composition
patents; use patents for a particular approved indication or method of using
the product; and certain other patents as detailed on FDA Form 3542. This
information, as provided by the sponsor on FDA form 3542, will be published
as described above.
A requirement for submission of patent information to FDA for certain
old antibiotics became effective October 7, 2008 under section 4(b)(1) of the
Q1 Act. A guidance for industry on this subject is available at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048345.pdf
Upon approval, patent numbers and expiration dates, in addition to
certain other information on appropriate patents claiming drug products that
are the subject of approved applications, will be published daily in the
Electronic Orange Book Query. The Addendum lists patent and exclusivity
information up to January of the Edition year. The monthly Cumulative
Supplements to the annual edition list patent and exclusivity information
changes since the Annual Edition Addendum. Since all parts of this
publication are subject to changes, additions, or deletions, the Electronic
Orange Book, updated daily, should be consulted for the most recent patent
and exclusivity information.

AD 2

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 1 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ABACAVIR SULFATE - ZIAGEN

N020977 001 5034394
5034394*PED
6294540
6294540*PED

Dec
Jun
May
Nov

18,
18,
14,
14,

2011
2012
2018
2018

DS

DP

DS

DP

ABACAVIR SULFATE - ZIAGEN

N020978 001 5034394
5034394*PED
6294540
6294540*PED
6641843
6641843*PED

Dec
Jun
May
Nov
Feb
Aug

18,
18,
14,
14,
04,
04,

2011
2012
2018
2018
2019
2019

DS

DP

DS

DP

ABACAVIR SULFATE; LAMIVUDINE - EPZICOM

N021652 001 5034394
Dec 18,
5034394*PED
Jun 18,
5905082
May 18,
Nov 18,
5905082*PED
May 14,
6294540
Nov 14,
6294540*PED
Mar 28,
6417191

2011
2012
2016
2016
2018
2018
2016

DS

DP

DS

DP

DS

DP

U-257

DP

U-257

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-65
U-65

U-65
U-65

DP

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE - TRIZIVIR

DS
N021205 001 5034394
Dec 18, 2011
5034394*PED
Jun 18, 2012
DS
5905082
May 18, 2016
Nov 18, 2016
5905082*PED
May 14, 2018
DS
6294540
Nov 14, 2018
6294540*PED
Mar 28, 2016
6417191
ABARELIX - PLENAXIS
N021320 001 5843901
5968895
6180608
6423686
6455499
6699833

Dec
Dec
Dec
Jun
Jun
Dec

01,
11,
11,
07,
07,
11,

2015
2016
2016
2015
2015
2016

DS

ABIRATERONE ACETATE - ZYTIGA

N202379 001 5604213

Feb

18, 2014

DS

ACETAMINOPHEN - OFIRMEV
N022450 001 6028222
6992218

Aug
Jun

05, 2017
06, 2021

DP
DP

U-248

DP
DP

U-65
U-65
U-248

DP
DP
DP

U-549

DS
U-549
DP

DP

U-1126

DP
DP

NCE

Apr

28, 2016

NP

Nov

02, 2013

NC

Jul

31, 2012

NDF

Mar

17, 2013

ACETAMINOPHEN; ASPIRIN; CAFFEINE - EXCEDRIN (MIGRAINE)

N020802 001 5972916
Jul 14, 2017
U-296
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE - ULTRACET
DS
N021123 001 RE39221
Aug 09, 2011
ACETYLCHOLINE CHLORIDE - MIOCHOL-E
N020213 001 6261546
Apr

29, 2019

ACYCLOVIR; HYDROCORTISONE - XERESE

N022436 001 6514980
Jan
7223387
Feb
RE39264
Feb

24, 2017
28, 2021
02, 2016

ADAPALENE - DIFFERIN
N021753 001 7579377
7737181
7834060
7838558
7868044

Feb
Aug
Mar
Mar
Mar

23,
29,
12,
12,
12,

ADAPALENE - DIFFERIN
N022502 001 7998467

May

31, 2028

2025
2024
2023
2023
2023

DP

U-55

U-506

DP
DP
DP

U-1006
U-1006
U-1006

U-818
DP
U-1078
DP
U-1078

DP

U-1078

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 2 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ADAPALENE; BENZOYL PEROXIDE - EPIDUO

N022320 001 7820186
Nov 23, 2025
7964202
Sep 01, 2024
8071644
Jul 18, 2027
8080537
Jul 18, 2027
ADEFOVIR DIPIVOXIL - HEPSERA
N021449 001 5663159
6451340

Sep
Jul

02, 2014
23, 2018

ADENOSINE - ADENOSCAN
N020059 001 5731296

Mar

24, 2015

DP
DP
DP

DS
DS

DP
DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NC

Dec

08, 2011

NPP

Sep

16, 2011

U-1078
U-1078
U-1078

U-470

U-221

ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE

N020760 001 5763454
Jun 15, 2015
6080756
Jul 05, 2016
6194429
Jul 23, 2018

U-282

ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE

N020760 002 5763454
Jun 15, 2015
6080756
Jul 05, 2016
6194429
Jul 23, 2018

U-282

ALBUMIN HUMAN - OPTISON

N020899 001 5529766
5558094
5573751
6723303

Jun
Feb
Apr
Apr

25,
28,
25,
20,

U-505
U-505

ALBUTEROL SULFATE - ACCUNEB

N020949 001 6702997

Dec

28, 2021

U-558

ALBUTEROL SULFATE - ACCUNEB

N020949 002 6702997

Dec

28, 2021

U-558

ALBUTEROL SULFATE - PROAIR HFA

N021457 001 5605674
Feb
7105152
Sep
7566445
Jun

25, 2014
12, 2023
04, 2017

ALBUTEROL SULFATE - PROVENTIL-HFA

N020503 001 5605674
Feb
5766573
Jun

25, 2014
16, 2015

2013
2012
2012
2021

PATENT
DELIST
REQUESTED

DP

DP
DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 3 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ALBUTEROL SULFATE - VENTOLIN HFA

N020983 001 6161724
Jan
6161724*PED
Jul
6170717
Dec
6170717*PED
Jun
6315173
Dec
6315173*PED
Jun
6431168
Jun
6431168*PED
Dec
6435372
Jan
6435372*PED
Jul
6510969
Dec
6510969*PED
Jun
6558651
Dec
6558651*PED
Jun
6596260
Aug
6596260*PED
Feb
6743413
Jun
6743413*PED
Dec
6938796
Jan
6938796*PED
Jul
6966467
Dec
6966467*PED
Jun
6997349
Jan
6997349*PED
Jul
7107986
Jun
7107986*PED
Dec
7143908
Jan
7143908*PED
Jul
7350676
Aug
7350676*PED
Feb
7500444
Jan
7500444*PED
Jul

16,
16,
23,
23,
23,
23,
08,
08,
16,
16,
23,
23,
19,
19,
10,
10,
01,
01,
16,
16,
23,
23,
16,
16,
08,
06,
16,
16,
24,
24,
04,
04,

PATENT
CODES

2018
2018
2017
2018
2017
2018
2018
2018
2018
2018
2017
2018
2016
2017
2014
2015
2021
2021
2018
2018
2017
2018
2018
2018
2018
2018
2018
2018
2018
2019
2025
2025

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP
DP
DP
DP
DP
DP

U-716

DP
U-716
DP
DP
DP
DP
DP
DP
DP

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - COMBIVENT

N020291 001 5603918
Jun 09, 2015
ALBUTEROL SULFATE; IPRATROPIUM
N021747 001 5405084
5472143
5497944
5662271
5911851
5964416
6007676
6149054
6176442
6453795
6503362
6726124
6846413
6977042
6988496
7104470
7246615
7284474
7396341
7802568
7837235
7896264
7988001

BROMIDE - COMBIVENT RESPIMAT

DP
Apr 11, 2012
DP
Sep 29, 2013
DP
Mar 12, 2013
DP
Sep 02, 2014
DP
Sep 29, 2013
Oct 04, 2016
DP
DP
Sep 29, 2013
DP
Dec 19, 2016
DP
Oct 04, 2016
Dec 05, 2016
DP
DP
Sep 29, 2013
DP
Oct 04, 2016
DP
Aug 28, 2018
DP
Aug 28, 2018
Feb 23, 2020
DP
DP
Oct 04, 2016
DP
May 31, 2016
DP
Aug 26, 2024
DP
Oct 10, 2026
Feb 26, 2019
DP
DP
Mar 13, 2028
DP
May 26, 2025
DP
Aug 04, 2021

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - DUONEB

N020950 001 6632842
Dec 28, 2021
ALCAFTADINE - LASTACAFT
N022134 001 5468743

Nov

21, 2012

NP

Oct

07, 2014

NCE

Jul

28, 2015

U-532

DS

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 4 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ALCOHOL; CHLORHEXIDINE GLUCONATE - AVAGARD

Jun 21, 2016
N021074 001 5897031
Jun 22, 2015
6090395
Jun 22, 2015
6534069
Jun 23, 2015
6623744
Aug 03, 2016
7081246
Jun 22, 2015
7566460
ALENDRONATE SODIUM - FOSAMAX
N020560 001 5358941
5358941*PED
5681590
5681590*PED
6090410
6090410*PED
6194004
6194004*PED

Dec
Jun
Dec
Jun
Dec
Jun
Dec
Jun

02,
02,
02,
02,
02,
02,
02,
02,

2012
2013
2012
2013
2012
2013
2012
2013

ALENDRONATE SODIUM - FOSAMAX

N020560 002 5358941
5358941*PED
5681590
5681590*PED
6090410
6090410*PED

Dec
Jun
Dec
Jun
Dec
Jun

02,
02,
02,
02,
02,
02,

2012
2013
2012
2013
2012
2013

ALENDRONATE SODIUM - FOSAMAX

N020560 003 5358941
5358941*PED
5681590
5681590*PED
6090410
6090410*PED

Dec
Jun
Dec
Jun
Dec
Jun

02,
02,
02,
02,
02,
02,

2012
2013
2012
2013
2012
2013

ALENDRONATE SODIUM - FOSAMAX

N020560 004 5358941
5358941*PED
5681590
5681590*PED
6090410
6090410*PED

Dec
Jun
Dec
Jun
Dec
Jun

02,
02,
02,
02,
02,
02,

2012
2013
2012
2013
2012
2013

ALENDRONATE SODIUM - FOSAMAX

N020560 005 5358941
5358941*PED
5681590
5681590*PED
6090410
6090410*PED

Dec
Jun
Dec
Jun
Dec
Jun

02,
02,
02,
02,
02,
02,

2012
2013
2012
2013
2012
2013

ALENDRONATE SODIUM - FOSAMAX

N021575 001 5462932
5462932*PED
5994329
5994329*PED
6015801
6015801*PED
6225294
6225294*PED

May
Nov
Jul
Jan
Jul
Jan
Jul
Jan

17,
17,
17,
17,
17,
17,
17,
17,

2014
2014
2018
2019
2018
2019
2018
2019

ALENDRONATE SODIUM; CHOLECALCIFEROL

N021762 001 5358941
Dec
5358941*PED
Jun
5681590
Dec
5681590*PED
Jun
5994329
Jul
5994329*PED
Jan
6090410
Dec
6090410*PED
Jun

PATENT
CODES

PATENT
DELIST
REQUESTED

DP
DP
U-1008
DP
DP

- FOSAMAX PLUS D
02, 2012
DP
02, 2013
DP
02, 2012
02, 2013
17, 2018
17, 2019
DP
02, 2012
DP
02, 2013

U-1008

Y
Y
Y

U-647

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 5 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ALENDRONATE SODIUM; CHOLECALCIFEROL

N021762 002 5358941
Dec
5358941*PED
Jun
5681590
Dec
5681590*PED
Jun
6090410
Dec
6090410*PED
Jun

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

- FOSAMAX PLUS D
02, 2012
DP
02, 2013
DP
02, 2012
02, 2013
DP
02, 2012
DP
02, 2013

ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE

A079013 001

PC

Jan

14, 2012

ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE

A079014 001

PC

Jan

14, 2012

ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE

A079054 001

PC

Jan

14, 2012

ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE

A079056 001

PC

Jan

14, 2012

ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE

A079057 001

PC

Jan

14, 2012

M-97
PED

Dec
Jun

15, 2013
15, 2014

ALFUZOSIN HYDROCHLORIDE - UROXATRAL

N021287 001 4661491*PED
Jul 18, 2011
6149940
Aug 22, 2017
6149940*PED
Feb 22, 2018
ALISKIREN HEMIFUMARATE - TEKTURNA
N021985 001 5559111
Jul

21, 2018

DS

DP

U-3

NCE

Mar

05, 2012

ALISKIREN HEMIFUMARATE - TEKTURNA

N021985 002 5559111
Jul

21, 2018

DS

DP

U-3

NCE

Mar

05, 2012

NC
NCE

Aug
Mar

26, 2013
05, 2012

NC
NCE

Aug
Mar

26, 2013
05, 2012

NC
NCE

Aug
Mar

26, 2013
05, 2012

NC
NCE

Aug
Mar

26, 2013
05, 2012

NCE
NC

Mar
Dec

05, 2012
21, 2013

NCE
NC

Mar
Dec

05, 2012
21, 2013

NCE
NC

Mar
Dec

05, 2012
21, 2013

NCE
NC

Mar
Dec

05, 2012
21, 2013

NCE
NC

Mar
Dec

05, 2012
21, 2013

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO

N022545 001
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N022545 002
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N022545 003
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N022545 004
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N200045 001 5559111
Jul 21, 2018
DS DP U-3
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N200045 002 5559111
Jul 21, 2018
DS DP U-3
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N200045 003 5559111
Jul 21, 2018
DS DP U-3
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N200045 004 5559111
Jul 21, 2018
DS DP U-3
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N200045 005 5559111
Jul 21, 2018
DS DP U-3

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 6 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT

N022107 001 5559111
Jul 21, 2018
DS DP U-3
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N022107 002 5559111
Jul 21, 2018
DS DP U-3
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N022107 003 5559111
Jul 21, 2018
DS DP U-3
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N022107 004 5559111
Jul 21, 2018
DS DP U-3

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-600
NCE

Jul
Mar

16, 2012
05, 2012

I-600
NCE

Jul
Mar

16, 2012
05, 2012

I-600
NCE

Jul
Mar

16, 2012
05, 2012

I-600
NCE

Jul
Mar

16, 2012
05, 2012

ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA

N022217 001 5399578
Mar 21, 2012
5559111
Jul 21, 2018

DS
DS

DP
DP

U-3
U-3

NCE
NC

Mar
Sep

05, 2012
16, 2012

ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA

N022217 002 5399578
Mar 21, 2012
5559111
Jul 21, 2018

DS
DS

DP
DP

U-3
U-3

NCE
NC

Mar
Sep

05, 2012
16, 2012

ALITRETINOIN - PANRETIN
N020886 001 5932622

Aug

03, 2016

ALMOTRIPTAN MALATE - AXERT

N021001 001 5565447
5565447*PED

May
Nov

07, 2015
07, 2015

DS

DP

U-969

ALMOTRIPTAN MALATE - AXERT

N021001 002 5565447
5565447*PED

May
Nov

07, 2015
07, 2015

DS

DP

U-969

ALOSETRON HYDROCHLORIDE - LOTRONEX

N021107 001 5360800
Jan
6284770
Oct

13, 2013
05, 2018

DS

DP

U-405
U-405

ALOSETRON HYDROCHLORIDE - LOTRONEX

N021107 002 5360800
Jan
6284770
Oct

13, 2013
05, 2018

DS

DP

U-405
U-405

ALPRAZOLAM - NIRAVAM
N021726 001 6024981
6221392

Apr
Apr

09, 2018
09, 2018

DP
DP

ALPRAZOLAM - NIRAVAM
N021726 002 6024981
6221392

Apr
Apr

09, 2018
09, 2018

DP
DP

ALPRAZOLAM - NIRAVAM
N021726 003 6024981
6221392

Apr
Apr

09, 2018
09, 2018

DP
DP

ALPRAZOLAM - NIRAVAM
N021726 004 6024981
6221392

Apr
Apr

09, 2018
09, 2018

DP
DP

ALPROSTADIL - CAVERJECT
N020379 001 5741523

Apr

21, 2015

ALPROSTADIL - CAVERJECT
N020379 002 5741523

Apr

21, 2015

ALPROSTADIL - CAVERJECT
N020379 003 5741523

Apr

21, 2015

ALPROSTADIL - CAVERJECT
N020379 004 5741523

Apr

21, 2015

U-562

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 7 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ALPROSTADIL - CAVERJECT IMPULSE

Apr
N021212 001 5501673
Feb
5716338

16, 2013
10, 2015

DP
DP

ALPROSTADIL - CAVERJECT IMPULSE

N021212 002 5501673
Apr
5716338
Feb

16, 2013
10, 2015

DP
DP

ALPROSTADIL - MUSE
N020700 001 5474535
5886039

Dec
Mar

12, 2012
23, 2016

DP

U-155
U-155

ALPROSTADIL - MUSE
N020700 002 5474535
5886039

Dec
Mar

12, 2012
23, 2016

DP

U-155
U-155

ALPROSTADIL - MUSE
N020700 003 5474535
5886039

Dec
Mar

12, 2012
23, 2016

DP

U-155
U-155

ALPROSTADIL - MUSE
N020700 004 5474535
5886039

Dec
Mar

12, 2012
23, 2016

DP

U-155
U-155

ALVIMOPAN - ENTEREG
N021775 001 5250542
5434171
6469030

Mar
Dec
Nov

29, 2016
08, 2013
29, 2020

DS
DS

AMBRISENTAN - LETAIRIS
N022081 001 5703017
5840722
7109205
7601730
RE42462

Dec
Nov
Oct
Oct
Oct

30,
24,
07,
07,
07,

2014
2015
2015
2015
2015

DS

AMBRISENTAN - LETAIRIS
N022081 002 5703017
5840722
7109205
7601730
RE42462

Dec
Nov
Oct
Oct
Oct

30,
24,
07,
07,
07,

2014
2015
2015
2015
2015

DS

AMIFOSTINE - ETHYOL
N020221 001 5424471
5591731
5994409

Jul
Jul
Dec

31, 2012
31, 2012
08, 2017

U-305

AMIFOSTINE - ETHYOL
N020221 002 5424471
5591731
5994409

Jul
Jul
Dec

31, 2012
31, 2012
08, 2017

U-305

LEVULAN
30, 2013
31, 2017
01, 2018
17, 2019

U-289
U-289
U-289
U-289

AMINOLEVULINIC ACID HYDROCHLORIDE Sep

N020965 001 5079262
Oct
5954703
May
6709446
Jun
7723910

DP
DP

U-878
U-878
U-879

U-821
DS

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

May

20, 2013

NCE
ODE

Jun
Jun

15, 2012
15, 2014

NCE
ODE

Jun
Jun

15, 2012
15, 2014

M-82

Mar

12, 2013

DP
U-1080

DS

U-821
DS

DP
U-1080

DS

AMIODARONE HYDROCHLORIDE - NEXTERONE

N022325 001 6869939
May 04, 2022
7635773
Mar 13, 2029

DP
DP

AMIODARONE HYDROCHLORIDE - NEXTERONE

May 04, 2022
N022325 002 6869939
Mar 13, 2029
7635773

DP
DP

AMIODARONE HYDROCHLORIDE - NEXTERONE

May 04, 2022
N022325 003 6869939
Mar 13, 2029
7635773

DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 8 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

AMLEXANOX - APHTHASOL
N020511 001 5362737

PATENT
EXPIRATION
DATE

Nov

PATENT
CODES

08, 2011

U-243

AMLODIPINE BESYLATE - AMLODIPINE BESYLATE

N022026 001 6828339
Nov 20, 2022

DS

AMLODIPINE BESYLATE - AMLODIPINE BESYLATE

N022026 002 6828339
Nov 20, 2022

DS

AMLODIPINE BESYLATE - AMLODIPINE BESYLATE

N022026 003 6828339
Nov 20, 2022

DS

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N021540 001 5686104
Nov 11, 2014
5686104*PED
May 11, 2015
5969156
Jul 08, 2016
DS
5969156*PED
Jan 08, 2017
6126971
Jan 19, 2013
6126971*PED
Jul 19, 2013
6455574
Aug 11, 2018
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 002 5686104
Nov 11, 2014
5686104*PED
May 11, 2015
5969156
Jul 08, 2016
DS
5969156*PED
Jan 08, 2017
6126971
Jan 19, 2013
6126971*PED
Jul 19, 2013
6455574
Aug 11, 2018
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 003 5686104
Nov 11, 2014
5686104*PED
May 11, 2015
5969156
Jul 08, 2016
DS
5969156*PED
Jan 08, 2017
6126971
Jan 19, 2013
6126971*PED
Jul 19, 2013
6455574
Aug 11, 2018
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 004 5686104
Nov 11, 2014
5686104*PED
May 11, 2015
DS
5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
6126971
Jan 19, 2013
6126971*PED
Jul 19, 2013
6455574
Aug 11, 2018
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 005 5686104
Nov 11, 2014
5686104*PED
May 11, 2015
DS
5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
6126971
Jan 19, 2013
6126971*PED
Jul 19, 2013
6455574
Aug 11, 2018
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 006 5686104
Nov 11, 2014
5686104*PED
May 11, 2015
DS
5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
6126971
Jan 19, 2013
6126971*PED
Jul 19, 2013
6455574
Aug 11, 2018

DP

U-213

DP
U-552

DP

U-213

DP
U-552

DP

U-213

DP
U-552

DP

U-213

DP
U-552

DP

U-213

DP
U-552

DP

U-213

DP
U-552

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 9 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET

N021540 007 5686104
Nov 11, 2014
5686104*PED
May 11, 2015
DS
5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
6126971
Jan 19, 2013
6126971*PED
Jul 19, 2013
6455574
Aug 11, 2018
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 008 5686104
Nov 11, 2014
5686104*PED
May 11, 2015
DS
5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
6126971
Jan 19, 2013
6126971*PED
Jul 19, 2013
6455574
Aug 11, 2018
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 009 5686104
Nov 11, 2014
5686104*PED
May 11, 2015
DS
5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
6126971
Jan 19, 2013
6126971*PED
Jul 19, 2013
6455574
Aug 11, 2018
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 010 5686104
Nov 11, 2014
5686104*PED
May 11, 2015
DS
5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
6126971
Jan 19, 2013
6126971*PED
Jul 19, 2013
6455574
Aug 11, 2018
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N021540 011 5686104
Nov 11, 2014
5686104*PED
May 11, 2015
DS
5969156
Jul 08, 2016
5969156*PED
Jan 08, 2017
6126971
Jan 19, 2013
6126971*PED
Jul 19, 2013
6455574
Aug 11, 2018

PATENT
CODES
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-213

DP
U-552

DP

U-213

DP
U-552

DP

U-213

DP
U-552

DP

U-213

DP
U-552

DP

U-213

DP
U-552

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

A078381 005
PC
Jul 02, 2011
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
A078381 006
PC
Jul 02, 2011
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 002 6162802
Dec 19, 2017
U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 003 6162802
Dec 19, 2017
U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 004 6162802
Dec 19, 2017
U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 005 6162802
Dec 19, 2017
U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 006 6162802
Dec 19, 2017
DS DP U-185
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N020364 007 6162802
Dec 19, 2017
DS DP U-185

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 10 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR

N200175 001 5616599
Apr 25, 2016
DS DP U-3
5616599*PED
Oct 25, 2016

NC

Jul

23, 2013

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR

N200175 002 5616599
Apr 25, 2016
DS DP U-3
5616599*PED
Oct 25, 2016

NC

Jul

23, 2013

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR

N200175 003 5616599
Apr 25, 2016
DS DP U-3
5616599*PED
Oct 25, 2016

NC

Jul

23, 2013

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR

N200175 004 5616599
Apr 25, 2016
DS DP U-3
5616599*PED
Oct 25, 2016

NC

Jul

23, 2013

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR

N200175 005 5616599
Apr 25, 2016
DS DP U-3
5616599*PED
Oct 25, 2016

NC

Jul

23, 2013

NC

Apr

30, 2012

NC

Apr

30, 2012

NC

Apr

30, 2012

NC

Apr

30, 2012

NC

Apr

30, 2012

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT

N022314 001 5399578
Mar 21, 2012
DS DP U-3
5399578*PED
Sep 21, 2012
DP U-3
6294197
Jun 18, 2017
6294197*PED
Dec 18, 2017
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N022314 002 5399578
Mar 21, 2012
DS DP U-3
5399578*PED
Sep 21, 2012
6294197
Jun 18, 2017
DP U-3
6294197*PED
Dec 18, 2017
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N022314 003 5399578
Mar 21, 2012
DS DP U-3
5399578*PED
Sep 21, 2012
DP U-3
6294197
Jun 18, 2017
6294197*PED
Dec 18, 2017
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N022314 004 5399578
Mar 21, 2012
DS DP U-3
5399578*PED
Sep 21, 2012
DP U-3
6294197
Jun 18, 2017
6294197*PED
Dec 18, 2017
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N022314 005 5399578
Mar 21, 2012
DS DP U-3
5399578*PED
Sep 21, 2012
6294197
Jun 18, 2017
DP U-3
6294197*PED
Dec 18, 2017
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N022100 001 5616599
Apr 25, 2016
DS
5616599*PED
Oct 25, 2016

DP

U-3

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR

N022100 002 5616599
Apr 25, 2016
DS
5616599*PED
Oct 25, 2016

DP

U-3

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR

N022100 003 5616599
Apr 25, 2016
DS
5616599*PED
Oct 25, 2016

DP

U-3

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR

N022100 004 5616599
Apr 25, 2016
DS
5616599*PED
Oct 25, 2016

DP

U-3

AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA

N022401 001 5591762
Jan 07, 2014

DS

DP

U-3

NC

Oct

16, 2012

AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA

N022401 002 5591762
Jan 07, 2014

DS

DP

U-3

NC

Oct

16, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 11 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA

N022401 003 5591762
Jan 07, 2014

DS

DP

U-3

NC

Oct

16, 2012

AMLODIPINE BESYLATE; TELMISARTAN - TWYNSTA

N022401 004 5591762
Jan 07, 2014

DS

DP

U-3

NC

Oct

16, 2012

DS

DP

U-3

DP

U-3

NCE
W

Aug
Aug

23, 2012
23, 2012

AMLODIPINE BESYLATE; VALSARTAN

N021990 002 5399578
5399578*PED
6294197
6294197*PED
6395728

- EXFORGE
Mar 21, 2012
Sep 21, 2012
Jun 18, 2017
Dec 18, 2017
Jul 08, 2019

AMLODIPINE BESYLATE; VALSARTAN

N021990 003 5399578
5399578*PED
6294197
6294197*PED
6395728

- EXFORGE
Mar 21, 2012
Sep 21, 2012
Jun 18, 2017
Dec 18, 2017
Jul 08, 2019

AMLODIPINE BESYLATE; VALSARTAN

N021990 004 5399578
5399578*PED
6294197
6294197*PED
6395728

- EXFORGE
Mar 21, 2012
Sep 21, 2012
Jun 18, 2017
Dec 18, 2017
Jul 08, 2019

AMLODIPINE BESYLATE; VALSARTAN

N021990 005 5399578
5399578*PED
6294197
6294197*PED
6395728

- EXFORGE
Mar 21, 2012
Sep 21, 2012
Jun 18, 2017
Dec 18, 2017
Jul 08, 2019

DP

DS

DP

U-3

DP

U-3

DP

DS

DP

U-3

DP

U-3

DP

DS

DP

U-3

DP

U-3

DP

AMMONIA, N-13 - AMMONIA N 13

N022119 001
AMOXICILLIN - MOXATAG
N050813 001 6544555
6669948
6723341

Oct
Oct
Oct

13, 2020
13, 2020
13, 2020

DS
DS
DS

AMOXICILLIN; CLAVULANATE POTASSIUM - AUGMENTIN XR

N050785 001 6746692
Apr 04, 2020
6783773
Apr 04, 2020
6878386
Apr 04, 2020
7217430
Apr 04, 2020
7250176
Apr 04, 2020

DP
DP
DP

U-897
U-897
U-897

DP
DP
DP

U-926
U-926
U-926

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 10

N011522 007 6384020
Jul 06, 2020
6384020*PED
Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 12.5
N011522 012 6384020
Jul 06, 2020
6384020*PED
Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 15
N011522 013 6384020
Jul 06, 2020
6384020*PED
Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 20
N011522 008 6384020
Jul 06, 2020
6384020*PED
Jan 06, 2021

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 12 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 30

N011522 010 6384020
Jul 06, 2020
6384020*PED
Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 5
N011522 009 6384020
Jul 06, 2020
6384020*PED
Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL 7.5
N011522 011 6384020
Jul 06, 2020
6384020*PED
Jan 06, 2021
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 10
N021303 001 6322819
Oct 21, 2018
6322819*PED
Apr 21, 2019
6605300
Oct 21, 2018
6605300*PED
Apr 21, 2019
DP
RE41148
Oct 21, 2018
RE41148*PED
Apr 21, 2019
DP
RE42096
Oct 21, 2018
RE42096*PED
Apr 21, 2019
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 15
N021303 006 6322819
Oct 21, 2018
6322819*PED
Apr 21, 2019
6605300
Oct 21, 2018
6605300*PED
Apr 21, 2019
DP
RE41148
Oct 21, 2018
RE41148*PED
Apr 21, 2019
RE42096
Oct 21, 2018
DP
RE42096*PED
Apr 21, 2019
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 20
N021303 002 6322819
Oct 21, 2018
6322819*PED
Apr 21, 2019
6605300
Oct 21, 2018
6605300*PED
Apr 21, 2019
RE41148
Oct 21, 2018
DP
RE41148*PED
Apr 21, 2019
DP
RE42096
Oct 21, 2018
RE42096*PED
Apr 21, 2019
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 25
N021303 004 6322819
Oct 21, 2018
6322819*PED
Apr 21, 2019
6605300
Oct 21, 2018
6605300*PED
Apr 21, 2019
DP
RE41148
Oct 21, 2018
RE41148*PED
Apr 21, 2019
DP
RE42096
Oct 21, 2018
RE42096*PED
Apr 21, 2019
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 30
N021303 003 6322819
Oct 21, 2018
6322819*PED
Apr 21, 2019
6605300
Oct 21, 2018
6605300*PED
Apr 21, 2019
DP
RE41148
Oct 21, 2018
RE41148*PED
Apr 21, 2019
DP
RE42096
Oct 21, 2018
RE42096*PED
Apr 21, 2019

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 13 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ADDERALL XR 5

N021303 005 6322819
Oct 21, 2018

6322819*PED
Apr 21, 2019

6605300
Oct 21, 2018

6605300*PED
Apr 21, 2019

DP

RE41148
Oct 21, 2018
RE41148*PED
Apr 21, 2019

DP

RE42096
Oct 21, 2018
RE42096*PED
Apr 21, 2019

AMPHOTERICIN B - ABELCET
N050724 001 5616334
6406713

Apr
Jun

01, 2014
18, 2019

AMPHOTERICIN B - AMBISOME
N050740 001 5874104
5965156

Feb
Oct

23, 2016
12, 2016

AMPRENAVIR - AGENERASE
N021007 001 5585397
5646180
5723490
6730679

Dec
Jul
Mar
Nov

17,
08,
03,
11,

2013
2014
2015
2017

AMPRENAVIR - AGENERASE
N021007 002 5585397
5646180
5723490
6730679

Dec
Jul
Mar
Nov

17,
08,
03,
11,

2013
2014
2015
2017

AMPRENAVIR - AGENERASE
N021039 001 5585397
5646180
5723490

Dec
Jul
Mar

17, 2013
08, 2014
03, 2015

DS
DS

DP
DP

U-922
U-922

U-257
U-257
DP

U-257
U-257
DP

U-257
U-257

ANASTROZOLE - ARIMIDEX
N020541 001
ANIDULAFUNGIN - ERAXIS
N021632 001 5965525
6384013
6743777
6960564
7709444

Feb
Mar
Mar
Apr
Apr

17,
19,
19,
12,
12,

2020
2012
2012
2021
2021

DS
DS

ANIDULAFUNGIN - ERAXIS
N021632 002 5965525
6384013
6743777
6960564
7709444

Feb
Mar
Mar
Apr
Apr

17,
19,
19,
12,
12,

2020
2012
2012
2021
2021

DS
DS

APREPITANT - EMEND
N021549 001 5538982
5719147
6048859
6096742
6235735
6235735
7214692

Jul
Apr
Jun
Jul
Jun
Jun
Sep

23,
17,
29,
01,
29,
29,
18,

2013
2015
2012
2018
2012
2012
2012

DP

U-540

DP
DP
DP

U-540
U-540
U-540

DP

U-540

DP
DP
DP

U-540
U-540
U-540

DS

DP

DS

DP

U-745
U-853
U-745
U-745
U-747
U-746
U-853

M-61
PED

Dec
Jun

05, 2011
05, 2012

M-82

Mar

19, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 14 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

APREPITANT - EMEND
N021549 002 5538982
5719147
6048859
6096742
6235735
6235735
7214692

Jul
Apr
Jun
Jul
Jun
Jun
Sep

23,
17,
29,
01,
29,
29,
18,

2013
2015
2012
2018
2012
2012
2012

APREPITANT - EMEND
N021549 003 5538982
5719147
6048859
6096742
6235735
6235735
7214692

Jul
Apr
Jun
Jul
Jun
Jun
Sep

23,
17,
29,
01,
29,
29,
18,

2013
2015
2012
2018
2012
2012
2012

ARBUTAMINE HYDROCHLORIDE - GENESA

N020420 001 5395970
Mar

07, 2012

ARFORMOTEROL TARTRATE - BROVANA

Apr
N021912 001 5795564
Nov
6040344
Apr
6068833
Nov
6472563
Apr
6589508
Nov
6720453
Apr
6866839
Nov
7145036

03,
12,
03,
09,
03,
09,
03,
09,

ARGATROBAN - ARGATROBAN
N020883 001 5214052

30, 2014

Jun

2012
2016
2012
2021
2012
2021
2012
2021

PATENT
CODES

DS

DP

DS

DP

DS

DP

DS

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-745
U-853
U-745
U-745
U-747
U-746
U-853

M-82

Mar

19, 2013

U-745
U-853
U-745
U-745
U-747
U-746
U-853

M-82

Mar

19, 2013

U-793
DS
U-793
DS
U-793
DS
U-793
DS

ARGATROBAN - ARGATROBAN IN SODIUM CHLORIDE

Sep 26, 2027
N022434 001 7589106
Sep 26, 2027
7687516

DP
DP

U-1163
U-1164

ARIPIPRAZOLE - ABILIFY
N021436 001 5006528
5006528*PED

Oct
Apr

20, 2014
20, 2015

DS

DP

U-761

I-633
I-616
PED

Feb
Nov
Aug

16, 2014
19, 2012
27, 2011

ARIPIPRAZOLE - ABILIFY
N021436 002 5006528
5006528*PED

Oct
Apr

20, 2014
20, 2015

DS

DP

U-761

I-633
I-616
PED

Feb
Nov
Aug

16, 2014
19, 2012
27, 2011

ARIPIPRAZOLE - ABILIFY
N021436 003 5006528
5006528*PED

Oct
Apr

20, 2014
20, 2015

DS

DP

U-761

I-633
I-616
PED

Feb
Nov
Aug

16, 2014
19, 2012
27, 2011

ARIPIPRAZOLE - ABILIFY
N021436 004 5006528
5006528*PED

Oct
Apr

20, 2014
20, 2015

DS

DP

U-761

I-633
I-616
PED

Feb
Nov
Aug

16, 2014
19, 2012
27, 2011

ARIPIPRAZOLE - ABILIFY
N021436 005 5006528
5006528*PED

Oct
Apr

20, 2014
20, 2015

DS

DP

U-761

I-633
I-616
PED

Feb
Nov
Aug

16, 2014
19, 2012
27, 2011

ARIPIPRAZOLE - ABILIFY
N021436 006 5006528
5006528*PED

Oct
Apr

20, 2014
20, 2015

DS

DP

U-761

I-633
I-616
PED

Feb
Nov
Aug

16, 2014
19, 2012
27, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 15 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ARIPIPRAZOLE - ABILIFY
N021713 001 5006528
5006528*PED
6977257
6977257*PED

Oct
Apr
Apr
Oct

20,
20,
24,
24,

2014
2015
2022
2022

DS

DP

DS

DP

ARIPIPRAZOLE - ABILIFY
N021729 002 5006528
5006528*PED

Oct
Apr

20, 2014
20, 2015

DS

ARIPIPRAZOLE - ABILIFY
N021729 003 5006528
5006528*PED

Oct
Apr

20, 2014
20, 2015

ARIPIPRAZOLE - ABILIFY
N021729 004 5006528
5006528*PED

Oct
Apr

ARIPIPRAZOLE - ABILIFY
N021729 005 5006528
5006528*PED

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-761

I-633
PED

Feb
Aug

16, 2014
27, 2011

DP

U-761

I-633
PED

Feb
Aug

16, 2014
27, 2011

DS

DP

U-761

I-633
PED

Feb
Aug

16, 2014
27, 2011

20, 2014
20, 2015

DS

DP

U-761

PED

Aug

27, 2011

Oct
Apr

20, 2014
20, 2015

DS

DP

U-761

PED

Aug

27, 2011

ARIPIPRAZOLE - ABILIFY
N021866 001 5006528
5006528*PED
7115587
7115587*PED
7550445
7550445*PED

Oct
Apr
Jul
Jan
Jul
Jan

20,
20,
21,
21,
21,
21,

2014
2015
2024
2025
2024
2025

DS

DP

U-763

I-633
PED

Feb
Aug

16, 2014
27, 2011

DS

DP

U-764

ARMODAFINIL - NUVIGIL
N021875 001 7132570
7132570*PED
7297346
7297346*PED
RE37516
RE37516*PED

Dec
Jun
Nov
May
Oct
Apr

18,
18,
29,
29,
06,
06,

2023
2024
2023
2024
2014
2015

DS

ARMODAFINIL - NUVIGIL
N021875 002 7132570
7132570*PED
7297346
7297346*PED
RE37516
RE37516*PED

Dec
Jun
Nov
May
Oct
Apr

18,
18,
29,
29,
06,
06,

2023
2024
2023
2024
2014
2015

DS

ARMODAFINIL - NUVIGIL
N021875 003 7132570
7132570*PED
7297346
7297346*PED
RE37516
RE37516*PED

Dec
Jun
Nov
May
Oct
Apr

18,
18,
29,
29,
06,
06,

2023
2024
2023
2024
2014
2015

DS

ARMODAFINIL - NUVIGIL
N021875 004 7132570
7132570*PED
7297346
7297346*PED
RE37516
RE37516*PED

Dec
Jun
Nov
May
Oct
Apr

18,
18,
29,
29,
06,
06,

2023
2024
2023
2024
2014
2015

DS

ARMODAFINIL - NUVIGIL
N021875 005 7132570
7132570*PED
7297346
7297346*PED
RE37516
RE37516*PED

Dec
Jun
Nov
May
Oct
Apr

18,
18,
29,
29,
06,
06,

2023
2024
2023
2024
2014
2015

DS

DP

DP
DP
DP

U-820

DP
DP
DP

U-820

DP
DP
DP

U-820

DP
DP
DP

U-820

DP
DP
DP

U-820

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 16 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

ARSENIC TRIOXIDE - TRISENOX

N021248 001 6723351
6855339
6861076
6884439
6982096

PATENT
EXPIRATION
DATE

Nov
Nov
Nov
Nov
Nov

ARTEMETHER; LUMEFANTRINE - COARTEM

N022268 001 5677331
Oct

10,
10,
10,
10,
10,

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-573
U-617
U-617
U-651
U-651

2018
2018
2018
2018
2018

DP

14, 2014

U-977

NCE
ODE

Apr
Apr

07, 2014
07, 2016

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE
HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E - M.V.I.-12
(WITHOUT VITAMIN K)
N008809 006
ODE
Sep 09, 2011
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM
SULFATE - MOVIPREP
N021881 001 7169381
Sep 01, 2024
DS DP
7658914
Sep 01, 2024
DS DP
ASENAPINE MALEATE - SAPHRIS
N022117 001 5763476
7741358

Jun
Apr

09, 2015
06, 2026

DS

DP
DP

U-326
U-1064

I-629
I-628
NCE

Sep
Sep
Aug

03, 2013
03, 2013
13, 2014

ASENAPINE MALEATE - SAPHRIS

N022117 002 5763476
7741358

Jun
Apr

09, 2015
06, 2026

DS

DP
DP

U-326
U-1064

I-629
I-628
NCE

Sep
Sep
Aug

03, 2013
03, 2013
13, 2014

ASPIRIN; DIPYRIDAMOLE - AGGRENOX

N020884 001 6015577
Jan

18, 2017

U-302

ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)

N021387 001 5622985
Apr 22, 2014
U-335
U-335
5622985*PED
Oct 22, 2014
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
U-335
N021387 002 5622985
Apr 22, 2014
U-335
5622985*PED
Oct 22, 2014
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
U-335
N021387 003 5622985
Apr 22, 2014
U-335
5622985*PED
Oct 22, 2014
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
U-335
N021387 004 5622985
Apr 22, 2014
U-335
5622985*PED
Oct 22, 2014
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
U-335
N021387 005 5622985
Apr 22, 2014
U-335
5622985*PED
Oct 22, 2014
ASPIRIN; PRAVASTATIN SODIUM - PRAVIGARD PAC (COPACKAGED)
U-335
N021387 006 5622985
Apr 22, 2014
5622985*PED
Oct 22, 2014
U-335
ATAZANAVIR SULFATE - REYATAZ
N021567 001 5849911
6087383

Jun
Dec

20, 2017
21, 2018

DS
DS

DP
DP

U-167

D-130
D-116

Feb
Sep

04, 2014
30, 2011

ATAZANAVIR SULFATE - REYATAZ

N021567 002 5849911
6087383

Jun
Dec

20, 2017
21, 2018

DS
DS

DP
DP

U-167

D-130
D-116

Feb
Sep

04, 2014
30, 2011

ATAZANAVIR SULFATE - REYATAZ

N021567 003 5849911
6087383

Jun
Dec

20, 2017
21, 2018

DS
DS

DP
DP

U-167

D-130
D-116

Feb
Sep

04, 2014
30, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 17 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

ATAZANAVIR SULFATE - REYATAZ

N021567 004 5849911
6087383

PATENT
EXPIRATION
DATE

PATENT
CODES

EXCLUSIVITY
EXPIRATION
DATE

D-130
D-116

Feb
Sep

04, 2014
30, 2011

ATOMOXETINE HYDROCHLORIDE - STRATTERA

Nov 26, 2016
N021411 001 5658590
May 26, 2017
5658590*PED

U-494
U-494

M-78

Jul

23, 2011

ATOMOXETINE HYDROCHLORIDE - STRATTERA

Nov 26, 2016
N021411 002 5658590
May 26, 2017
5658590*PED

U-494
U-494

M-78

Jul

23, 2011

ATOMOXETINE HYDROCHLORIDE - STRATTERA

Nov 26, 2016
N021411 003 5658590
May 26, 2017
5658590*PED

U-494
U-494

M-78

Jul

23, 2011

ATOMOXETINE HYDROCHLORIDE - STRATTERA

Nov 26, 2016
N021411 004 5658590
May 26, 2017
5658590*PED

U-494
U-494

M-78

Jul

23, 2011

ATOMOXETINE HYDROCHLORIDE - STRATTERA

Nov 26, 2016
N021411 005 5658590
May 26, 2017
5658590*PED

U-494
U-494

M-78

Jul

23, 2011

ATOMOXETINE HYDROCHLORIDE - STRATTERA

Nov 26, 2016
N021411 006 5658590
May 26, 2017
5658590*PED

U-494
U-494

M-78

Jul

23, 2011

ATOMOXETINE HYDROCHLORIDE - STRATTERA

Nov 26, 2016
N021411 007 5658590
May 26, 2017
5658590*PED

U-494
U-494

M-78

Jul

23, 2011

ATOMOXETINE HYDROCHLORIDE - STRATTERA

N021411 008 5658590
Nov 26, 2016
5658590*PED
May 26, 2017

U-494
U-494

M-78

Jul

23, 2011

ATORVASTATIN CALCIUM - ATORVASTATIN CALCIUM

A076477 001

PC

May

28, 2012

ATORVASTATIN CALCIUM - ATORVASTATIN CALCIUM

A076477 002

PC

May

28, 2012

ATORVASTATIN CALCIUM - ATORVASTATIN CALCIUM

A076477 003

PC

May

28, 2012

ATORVASTATIN CALCIUM - ATORVASTATIN CALCIUM

A076477 004

PC

May

28, 2012

20, 2017
21, 2018

ATORVASTATIN CALCIUM - LIPITOR

N020702 001 5686104
5686104*PED
5969156
5969156*PED
6126971
6126971*PED

Nov
May
Jul
Jan
Jan
Jul

11,
11,
08,
08,
19,
19,

2014
2015
2016
2017
2013
2013

ATORVASTATIN CALCIUM - LIPITOR

N020702 002 5686104
5686104*PED
5969156
5969156*PED
6126971
6126971*PED

Nov
May
Jul
Jan
Jan
Jul

11,
11,
08,
08,
19,
19,

2014
2015
2016
2017
2013
2013

ATORVASTATIN CALCIUM - LIPITOR

N020702 003 5686104
5686104*PED
5969156
5969156*PED
6126971
6126971*PED

Nov
May
Jul
Jan
Jan
Jul

11,
11,
08,
08,
19,
19,

2014
2015
2016
2017
2013
2013

DP
DP

EXCLUSIVITY
CODE(S)

U-167

Jun
Dec

DS
DS

PATENT
DELIST
REQUESTED

DP

U-213
U-213

DS
DP

DP

U-213
U-213

DS
DP

DP
DS
DP

U-213
U-213

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 18 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ATORVASTATIN CALCIUM - LIPITOR

N020702 004 5686104
5686104*PED
5969156
5969156*PED
6126971
6126971*PED

Nov
May
Jul
Jan
Jan
Jul

11,
11,
08,
08,
19,
19,

ATOVAQUONE - MEPRON
N020500 001 6649659
6649659*PED

Jul
Jan

10, 2016
10, 2017

2014
2015
2016
2017
2013
2013

PATENT
CODES
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
EXPIRATION
DATE

U-213
U-213

DS
DP

DS

DP

U-69

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

N021078 001 5998449
Nov
5998449*PED
May
6166046
Nov
6166046*PED
May
6291488
Nov
6291488*PED
May

- MALARONE
25, 2013
25, 2014
25, 2013
25, 2014
25, 2013
25, 2014

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

N021078 002 5998449
Nov
5998449*PED
May
6166046
Nov
6166046*PED
May
6291488
Nov
6291488*PED
May

- MALARONE PEDIATRIC
25, 2013
U-990
25, 2014
25, 2013
25, 2014
U-406
25, 2013
25, 2014

U-990
U-406
U-406

AVOBENZONE; ECAMSULE; OCTOCRYLENE - ANTHELIOS SX

N021502 001 5587150
Dec 24, 2013

DP

U-752

AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE - ANTHELIOS 40

N022009 002
AZELAIC ACID - FINACEA
N021470 001 6534070

EXCLUSIVITY
CODE(S)

NP

Oct

29, 2012

Nov

18, 2018

AZELASTINE HYDROCHLORIDE - ASTEPRO

N022203 001 8071073
Jun

04, 2028

DP

NP

Oct

15, 2011

AZELASTINE HYDROCHLORIDE - ASTEPRO

N022371 001 8071073
Jun

04, 2028

DP

NP

Aug

31, 2012

AZILSARTAN KAMEDOXOMIL - EDARBI

N200796 001 5583141
Dec
5736555
Jun
5958961
Jun
7157584
May
7572920
Jan

10,
25,
06,
22,
07,

2013
2012
2014
2025
2025

DS
DS

NCE

Feb

25, 2016

AZILSARTAN KAMEDOXOMIL - EDARBI

N200796 002 5583141
Dec
5736555
Jun
5958961
Jun
7157584
May
7572920
Jan

10,
25,
06,
22,
07,

2013
2012
2014
2025
2025

DS
DS

NCE

Feb

25, 2016

NCE
NC

Feb
Dec

25, 2016
20, 2014

DP
DP
DP

U-3
U-3
U-3

DP

U-3

DP
DP
DP

U-3
U-3
U-3

DP

U-3

DS

DS

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR

N202331 001
AZITHROMYCIN - AZASITE
N050810 001 6159458
6239113
6569443
6861411
7056893

Nov
Mar
Mar
Nov
Mar

04,
31,
31,
25,
31,

AZITHROMYCIN - ZITHROMAX
N050693 001 6268489

Jul

31, 2018

DP

2017
2019
2019
2018
2019

DP
DP

DS

U-709
U-709
U-709
U-709
U-709

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 19 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

AZITHROMYCIN - ZITHROMAX
N050710 001 6268489

Jul

31, 2018

DS

AZITHROMYCIN - ZITHROMAX
N050710 002 6268489

Jul

31, 2018

DS

AZITHROMYCIN - ZITHROMAX
N050711 001 6268489

Jul

31, 2018

DS

AZITHROMYCIN - ZITHROMAX
N050730 001 6268489

Jul

31, 2018

DS

AZITHROMYCIN - ZITHROMAX
N050733 001 6268489

Jul

31, 2018

DS

AZITHROMYCIN - ZITHROMAX
N050784 001 6268489

Jul

31, 2018

DS

AZITHROMYCIN - ZMAX
N050797 001 6068859
6268489
6984403
7887844

May
Jul
Feb
Feb

30,
31,
14,
14,

AZTREONAM - CAYSTON
N050814 001 7208141
7214364
7427633

Dec
Dec
Dec

BACLOFEN - KEMSTRO
N021589 001 6024981
6221392

2017
2018
2024
2024

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DS
DP
DP

U-282

20, 2021
20, 2021
20, 2021

DP
DP
DP

U-1031

Apr
Apr

09, 2018
09, 2018

DP
DP

BACLOFEN - KEMSTRO
N021589 002 6024981
6221392

Apr
Apr

09, 2018
09, 2018

DP
DP

BALSALAZIDE DISODIUM - COLAZAL

N020610 001 7452872
7452872*PED
7625884
7625884*PED

Aug
Feb
Aug
Feb

24,
24,
24,
24,

2026
2027
2026
2027

ODE

Feb

22, 2017

ODE
PED

Dec
Jun

20, 2013
20, 2014

I-580
NCE
ODE

Oct
Mar
Mar

31, 2011
20, 2013
20, 2015

I-580
NCE
ODE

Oct
Mar
Mar

31, 2011
20, 2013
20, 2015

U-1031

U-141
U-141

BECLOMETHASONE DIPROPIONATE - QVAR 40

N020911 002 5605674
Feb 25, 2014
5683677
Nov 04, 2014
5776432
Jul 07, 2015
BECLOMETHASONE DIPROPIONATE - QVAR 80
N020911 001 5605674
Feb 25, 2014
5683677
Nov 04, 2014
5776432
Jul 07, 2015
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N022249 001

BENDAMUSTINE HYDROCHLORIDE - TREANDA

N022249 002

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ACANYA

N050819 001 5733886
Mar 31, 2015
6117843
Feb 18, 2012
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - DUAC
N050741 001 5466446
Feb 16, 2014

DP
DP

DS

DP

U-124

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 20 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

BENZYL ALCOHOL - ULESFIA

N022129 001 5858383
6139859
6793931
7294342

PATENT
EXPIRATION
DATE

Aug
Aug
Jul
May

BEPOTASTINE BESILATE - BEPREVE

N022288 001 6780877
Dec

11,
11,
11,
19,

PATENT
CODES

2017
2017
2022
2024

DP

25, 2017

DS

DP

BESIFLOXACIN HYDROCHLORIDE - BESIVANCE

N022308 001 5447926
Sep 05, 2012
Jun 29, 2021
6685958
Mar 31, 2019
6699492

DS

DP
DP
DP

PATENT
DELIST
REQUESTED

U-970
U-970
U-970
U-970

U-80
U-80
U-80

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE DS

N021852 001 5763426
Jun 09, 2015
6753013
Jan 27, 2020
6753013
Jan 27, 2020
DS
RE39706
Jun 09, 2015

TACLONEX
DP
DP U-88
DP U-193
DP

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE N022185 001 6753013

Jan 27, 2020
6753013
Jan 27, 2020
6787529
Jan 27, 2020
6787529
Jan 27, 2020
DS
RE39706
Jun 09, 2015

TACLONEX SCALP
DP U-88
DP U-193
DP U-193
DP U-88
DP

BETAMETHASONE VALERATE - LUXIQ

N020934 001 6126920
Mar
7078058
May

DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Apr

09, 2014

NCE

Sep

08, 2014

NCE

May

28, 2014

M-81
PED

Dec
Jun

19, 2011
19, 2012

NP

Dec

24, 2011

NP

Aug

31, 2013

U-484

01, 2016
24, 2017

BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE - BETOPTIC PILO

N020619 001 5635172
Jun 03, 2014
U-191
BEXAROTENE - TARGRETIN
N021055 001 5780676
5962731
6043279
6320074
7655699

Jul
Oct
Apr
Apr
Apr

14,
05,
22,
22,
22,

2015
2016
2012
2012
2012

BEXAROTENE - TARGRETIN
N021056 001 5780676
5962731
6043279
6320074
7655699

Jul
Oct
Apr
Apr
Apr

14,
05,
22,
22,
22,

2015
2016
2012
2012
2012

DS
DS

DP

U-509
U-475
U-509
U-509
U-509

U-510

DS
DS

DP

U-510
U-510
U-510

BICALUTAMIDE - CASODEX
N020498 001
BIMATOPROST - LATISSE
N022369 001 6403649
7351404
7388029
8017655
8038988

Sep
May
Jan
Nov
Aug

21,
25,
21,
27,
25,

BIMATOPROST - LUMIGAN
N021275 001 5688819
6403649
8017655

Aug
Sep
Nov

BIMATOPROST - LUMIGAN
N022184 001 5688819
6403649
7851504
8017655

Aug
Sep
Jun
Nov

2012
2024
2022
2012
2023

DS
U-939
U-938
DS
DS

DP
DP

19, 2014
21, 2012
27, 2012

DS
DS

DP
DP

19,
21,
13,
27,

DS
DS
DS

2014
2012
2027
2012

U-1208

U-446
U-446

U-1081
U-1081
DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 21 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

BISACODYL - HALFLYTELY
N021551 003 7291324

PATENT
EXPIRATION
DATE

Oct

PATENT
CODES

22, 2022

PATENT
DELIST
REQUESTED

U-837

EXCLUSIVITY
CODE(S)
NP

EXCLUSIVITY
EXPIRATION
DATE

Jul

16, 2013

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - HALFLYTELY
N021551 002 7291324
Oct 22, 2022
U-837
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE - PYLERA
N050786 001 6350468
Dec 14, 2018
U-932
U-956
6350468
Dec 14, 2018
BIVALIRUDIN - ANGIOMAX
N020873 001 5196404
5196404*PED
7582727
7582727*PED
7598343
7598343*PED

Aug
Feb
Jul
Jan
Jul
Jan

13,
13,
27,
27,
27,
27,

2012
2013
2028
2029
2028
2029

DS

BOCEPREVIR - VICTRELIS
N202258 001 7012066
7772178

Feb
Nov

22, 2022
11, 2027

DS

BORTEZOMIB - VELCADE
N021602 001 5780454
6083903
6297217
6297217
6297217
6617317
6713446
6747150
6958319
7119080

May
Oct
Oct
Oct
Oct
Oct
Jan
Oct
Jan
Oct

03,
28,
28,
28,
28,
28,
25,
28,
25,
28,

BOSENTAN - TRACLEER
N021290 001 5292740

Nov

BOSENTAN - TRACLEER
N021290 002 5292740

Nov

DP

U-1040

DP
DP

DP
DP

U-1128
U-1128

NCE

May

13, 2016

ODE

Mar

25, 2012

20, 2015

I-607

Aug

07, 2012

20, 2015

I-607

Aug

07, 2012

2017
2014
2014
2014
2014
2014
2022
2014
2022
2014

BRIMONIDINE TARTRATE - ALPHAGAN P

N021262 001 5424078
Jun
5424078*PED
Dec
6562873
Jul
6562873*PED
Jan
6627210
Jul
6627210*PED
Jan
6641834
Jul
6641834*PED
Jan
6673337
Jul
6673337*PED
Jan

13,
13,
10,
10,
18,
18,
28,
28,
26,
26,

2012
2012
2021
2022
2021
2022
2021
2022
2021
2022

BRIMONIDINE TARTRATE - ALPHAGAN P

N021770 001 5424078
Jun
5424078*PED
Dec
6562873
Jul
6562873*PED
Jan
6627210
Jul
6627210*PED
Jan
6641834
Jul
6641834*PED
Jan
6673337
Jul
6673337*PED
Jan

13,
13,
10,
10,
18,
18,
28,
28,
26,
26,

2012
2012
2021
2022
2021
2022
2021
2022
2021
2022

BRIMONIDINE TARTRATE - BRIMONIDINE TARTRATE

N021764 001 7265117
Aug 19, 2025

DP
DP

DS

U-515
U-515
U-885
U-884

DP
DP
DP
DP
DP

DP
DP
DP

DP
DP
DP
DP
DP

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 22 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

BRIMONIDINE TARTRATE; TIMOLOL MALEATE N021398 001 7030149

Apr 19,
7320976
Apr 19,
Jan 19,
7323463
Apr 19,
7642258

COMBIGAN
2022
2022
2023
DS
2022

BRINZOLAMIDE - AZOPT
N020816 001 5378703
5378703*PED
5461081
5461081*PED

2012
2012
2012
2013

Apr
Oct
Oct
Apr

01,
01,
24,
24,

DS

PATENT
DELIST
REQUESTED

DP
DP

U-1024

DP

U-224

DP

U-225

BROMOCRIPTINE MESYLATE - CYCLOSET

N020866 001 5468755
Nov
5679685
Oct
5716957
Feb
5756513
Nov
5866584
Nov
7888310
Jul

21,
21,
10,
21,
21,
25,

BUDESONIDE - ENTOCORT EC
N021324 001 5643602
5643602*PED

01, 2014
01, 2015

DP

BUDESONIDE - PULMICORT FLEXHALER

N021949 001 6027714
Jan
6142145
May
Jan
6287540
Mar
7143764

09,
08,
09,
13,

2018
2018
2018
2018

DP
DP
DP
DP

U-787

BUDESONIDE - PULMICORT FLEXHALER

N021949 002 6027714
Jan
6142145
May
Jan
6287540
Mar
7143764

09,
08,
09,
13,

2018
2018
2018
2018

DP
DP
DP
DP

U-787

BUDESONIDE - PULMICORT RESPULES

N020929 001 6598603
Dec
6598603*PED
Jun
6899099
Dec
6899099*PED
Jun
7524834
Nov
7524834*PED
May

23,
23,
23,
23,
11,
11,

2018
2019
2018
2019
2018
2019

BUDESONIDE - PULMICORT RESPULES

N020929 002 6598603
Dec
6598603*PED
Jun
6899099
Dec
6899099*PED
Jun
7524834
Nov
7524834*PED
May

23,
23,
23,
23,
11,
11,

2018
2019
2018
2019
2018
2019

BUDESONIDE - PULMICORT RESPULES

N020929 003 6598603
Dec
6598603*PED
Jun
6899099
Dec
6899099*PED
Jun
7524834
Nov
7524834*PED
May

23,
23,
23,
23,
11,
11,

2018
2019
2018
2019
2018
2019

BUDESONIDE - RHINOCORT
N020746 001 6291445
6291445*PED
6686346
6686346*PED
6986904
6986904*PED

29,
29,
29,
29,
29,
29,

2017
2017
2017
2017
2017
2017

Jul
Jan

Apr
Oct
Apr
Oct
Apr
Oct

EXCLUSIVITY
EXPIRATION
DATE

U-849
U-849

BROMFENAC SODIUM - BROMDAY

N021664 002

2012
2014
2015
2012
2012
2023

EXCLUSIVITY
CODE(S)

U-976
DP
U-976
U-976
U-976
U-976

U-655

U-529
U-529
DP

U-966

U-529
U-529
DP

U-966

U-529
U-529
DP

U-966

Y
DP

U-557

DP

U-699

NP

Oct

16, 2013

NP

May

05, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 23 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

BUDESONIDE - RHINOCORT
N020746 002 6291445
6291445*PED
6686346
6686346*PED
6986904
6986904*PED

PATENT
EXPIRATION
DATE

Apr
Oct
Apr
Oct
Apr
Oct

29,
29,
29,
29,
29,
29,

2017
2017
2017
2017
2017
2017

PATENT
CODES

DP

U-557

DP

U-699

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT

DP
N021929 001 5349945
Nov 12, 2011
5674860
Oct 07, 2014
DP
DP
5972919
Dec 17, 2012
DP
6123924
Sep 26, 2017
DP
6641800
Sep 23, 2012
DP
7367333
Nov 11, 2018
7587988
Apr 10, 2026
DP
DP
7759328
Jan 29, 2023
DP
7967011
Aug 11, 2021

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-582

Feb

27, 2012

I-582

Feb

27, 2012

BUPIVACAINE - EXPAREL
N022496 001

NP

Oct

28, 2014

BUPIVACAINE - EXPAREL
N022496 002

NP

Oct

28, 2014

NDF

Jun

30, 2013

NDF

Jun

30, 2013

NDF

Jun

30, 2013

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT

DP
N021929 002 5349945
Nov 12, 2011
DP
5674860
Oct 07, 2014
DP
5972919
Dec 17, 2012
DP
6123924
Sep 26, 2017
6641800
Sep 23, 2012
DP
DP
7367333
Nov 11, 2018
DP
7587988
Apr 10, 2026
DP
7759328
Jan 29, 2023
7897646
Sep 09, 2018
7967011
Aug 11, 2021
DP

U-1075
U-1075

U-1073

U-1075
U-1075

U-1073
U-1118

BUPRENORPHINE - BUTRANS
N021306 001 6264980
6344211
RE41408
RE41489
RE41571

Dec
Dec
Sep
Sep
Sep

18,
18,
29,
29,
29,

2015
2015
2017
2017
2017

DP

BUPRENORPHINE - BUTRANS
N021306 002 6264980
6344211
RE41408
RE41489
RE41571

Dec
Dec
Sep
Sep
Sep

18,
18,
29,
29,
29,

2015
2015
2017
2017
2017

DP

BUPRENORPHINE - BUTRANS
N021306 003 6264980
6344211
RE41408
RE41489
RE41571

Dec
Dec
Sep
Sep
Sep

18,
18,
29,
29,
29,

2015
2015
2017
2017
2017

DP

BUPRENORPHINE; NALOXONE - SUBOXONE

Sep
N022410 001 8017150

10, 2023

DP

NDF

Aug

30, 2013

BUPRENORPHINE; NALOXONE - SUBOXONE

Sep
N022410 002 8017150

10, 2023

DP

NDF

Aug

30, 2013

U-1072
U-1072
U-1072
U-1072

U-1072
U-1072
U-1072
U-1072

U-1072
U-1072
U-1072
U-1072

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 24 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

BUPROPION HYDROBROMIDE - APLENZIN

N022108 001 7241805
Jun
7569610
Jun
7572935
Jun
7585897
Jun
7645802
Jun
7649019
Jun
7662407
Jun
7671094
Jun

27,
27,
27,
27,
27,
27,
27,
27,

2026
2026
2026
2026
2026
2026
2026
2026

DP

BUPROPION HYDROBROMIDE - APLENZIN

N022108 002 7241805
Jun
7569610
Jun
7572935
Jun
7585897
Jun
7645802
Jun
7649019
Jun
7662407
Jun
7671094
Jun

27,
27,
27,
27,
27,
27,
27,
27,

2026
2026
2026
2026
2026
2026
2026
2026

DP

BUPROPION HYDROBROMIDE - APLENZIN

N022108 003 7241805
Jun
7569610
Jun
7572935
Jun
7585897
Jun
7645802
Jun
7649019
Jun
7662407
Jun
7671094
Jun

27,
27,
27,
27,
27,
27,
27,
27,

2026
2026
2026
2026
2026
2026
2026
2026

DP

BUPROPION HYDROCHLORIDE - FORFIVO XL

N022497 001 7674479
Jun 25, 2027
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
N020358 001 5358970
Aug 12, 2013
Aug 12, 2013
5427798
Aug 12, 2013
5731000
Aug 12, 2013
5763493
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
Aug 12, 2013
N020358 002 5358970
Aug 12, 2013
5427798
Aug 12, 2013
5731000
Aug 12, 2013
5763493
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
Aug 12, 2013
N020358 003 5358970
Aug 12, 2013
5427798
Aug 12, 2013
5731000
Aug 12, 2013
5763493
BUPROPION HYDROCHLORIDE - WELLBUTRIN SR
Aug 12, 2013
N020358 004 5358970
Aug 12, 2013
5427798
Aug 12, 2013
5731000
Aug 12, 2013
5763493
BUPROPION HYDROCHLORIDE - WELLBUTRIN XL
N021515 001 6096341
Oct 30, 2018
BUPROPION HYDROCHLORIDE - WELLBUTRIN XL
N021515 002 6096341
Oct 30, 2018
BUPROPION HYDROCHLORIDE - ZYBAN
Aug
N020711 002 5358970
Aug
5427798
Aug
5731000
Aug
5763493

12,
12,
12,
12,

2013
2013
2013
2013

U-997
DP
DP
DP
DP
DP
DP

U-997
DP
DP
DP
DP
DP
DP

U-997
DP
DP
DP
DP
DP
DP

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 25 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

BUPROPION HYDROCHLORIDE - ZYBAN

Aug
N020711 003 5358970
Aug
5427798
Aug
5731000
Aug
5763493

12,
12,
12,
12,

2013
2013
2013
2013

BUSULFAN - BUSULFEX
N020954 001 5430057
5430057*PED
5559148
5559148*PED

30,
30,
30,
30,

2013
2014
2013
2014

Sep
Mar
Sep
Mar

PATENT
CODES

17, 2017

DP

CABAZITAXEL - JEVTANA KIT

N201023 001 5438072
5698582
5847170
6331635
6372780
6387946
7241907

Nov
Jul
Mar
Mar
Mar
Mar
Dec

22,
03,
26,
26,
26,
26,
10,

DP
DP
DP
DP

CALCIPOTRIENE - DOVONEX
N020554 001 5763426
RE39706

Jun
Jun

09, 2015
09, 2015

DS
DS

DP
DP

CALCIPOTRIENE - DOVONEX
N020611 001 5763426
RE39706

Jun
Jun

09, 2015
09, 2015

DS
DS

DP
DP

Mar
Mar

DS
DS

CALCITRIOL - CALCIJEX
N018874 001 6051567
6051567*PED
6265392
6265392*PED
6274169
6274169*PED

Aug
Feb
Aug
Feb
Aug
Feb

02,
02,
02,
02,
02,
02,

2019
2020
2019
2020
2019
2020

CALCITRIOL - CALCIJEX
N018874 002 6051567
6051567*PED
6265392
6265392*PED
6274169
6274169*PED

Aug
Feb
Aug
Feb
Aug
Feb

02,
02,
02,
02,
02,
02,

2019
2020
2019
2020
2019
2020

CALCITRIOL - VECTICAL
N022087 001
CALCIUM ACETATE - PHOSLO
N021160 002 6576665

Apr

03, 2021

CALCIUM ACETATE - PHOSLO GELCAPS

Apr
N021160 003 6576665

03, 2021

NCE

Jun

17, 2015

NDF

Oct

06, 2013

NDF

Jan

23, 2012

U-1067
U-1067
DS

U-227

31, 2015
31, 2015

CALCITONIN SALMON RECOMBINANT - FORTICAL

N021406 001 6440392
Feb 02, 2021
RE40812
Feb 02, 2021

EXCLUSIVITY
EXPIRATION
DATE

U-457

CALCIPOTRIENE - SORILUX
N022563 001
CALCITONIN SALMON - MIACALCIN
N020313 002 5733569
5759565

EXCLUSIVITY
CODE(S)

U-263
U-263
U-264
U-264

BUTOCONAZOLE NITRATE - GYNAZOLE-1

N019881 001 5993856
Nov

2013
2012
2016
2016
2016
2016
2025

PATENT
DELIST
REQUESTED

DP
DP

U-227

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 26 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

CALCIUM CARBONATE; FAMOTIDINE;

N020958 001 5229137
5229137*PED
5989588
5989588*PED
6814978
6814978*PED

MAGNESIUM HYDROXIDE - PEPCID COMPLETE

May 16, 2012
U-349
Nov 16, 2012
U-349
Sep 30, 2015
U-349
Mar 30, 2016
DP
Aug 26, 2021
Feb 26, 2022

CALCIUM CARBONATE; RISEDRONATE

N021823 001 5583122
5583122*PED
5994329
5994329*PED
6015801
6015801*PED
6096342
6096342*PED
6165513
6165513*PED
6432932
6432932*PED
6465443
6465443*PED

SODIUM Dec 10,

Jun 10,
Jul 17,
Jan 17,
Jul 17,
Jan 17,
Nov 21,
May 21,
Jun 10,
Dec 10,
Jul 17,
Jan 17,
Aug 14,
Feb 14,

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ACTONEL WITH CALCIUM (COPACKAGED)

DS DP U-353
2013
2014
U-353
2018
2019
U-353
2018
2019
DP
2011
2012
DP
2018
2018
U-595
2018
2019
2018
DP
2019

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;
SODIUM CHLORIDE; SODIUM PHOSPHATE - NAVSTEL
Apr 25, 2012
DP U-891
N022193 001 5409904
NP
Jul 24, 2011
DP
Apr 25, 2012
5578578
DP U-891
Nov 29, 2021
7084130
CANDESARTAN CILEXETIL - ATACAND
N020838 001 5196444
Jun
5196444
Jun
5196444*PED
Dec
5534534
Jul
5534534*PED
Jan
5705517*PED
Oct
7538133*PED
Oct

04,
04,
04,
09,
09,
18,
18,

2012
2012
2012
2013
2014
2011
2011

DS
DS

CANDESARTAN CILEXETIL - ATACAND

N020838 002 5196444
Jun
5196444
Jun
5196444*PED
Dec
5534534
Jul
5534534*PED
Jan
5705517*PED
Oct
7538133*PED
Oct

04,
04,
04,
09,
09,
18,
18,

2012
2012
2012
2013
2014
2011
2011

DS
DS

CANDESARTAN CILEXETIL - ATACAND

N020838 003 5196444
Jun
5196444
Jun
5196444*PED
Dec
5534534
Jul
5534534*PED
Jan
5705517*PED
Oct
7538133*PED
Oct

04,
04,
04,
09,
09,
18,
18,

2012
2012
2012
2013
2014
2011
2011

DS
DS

CANDESARTAN CILEXETIL - ATACAND

N020838 004 5196444
Jun
5196444
Jun
5196444*PED
Dec
5534534
Jul
5534534*PED
Jan
5705517*PED
Oct
7538133*PED
Oct

04,
04,
04,
09,
09,
18,
18,

2012
2012
2012
2013
2014
2011
2011

DS
DS

DP
DP

U-660
U-3

DP

DP
DP

U-3
U-660

DP

DP
DP

U-3
U-660

DP

DP
DP
DP

U-660
U-3

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 27 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT

DS DP U-3
N021093 001 5196444
Jun 04, 2012
5196444*PED
Dec 04, 2012
DP
5534534
Jul 09, 2013
5534534*PED
Jan 09, 2014
5705517*PED
Oct 18, 2011
DP U-3
5721263
Feb 24, 2015
DP U-3
5958961
Jun 06, 2014
7538133*PED
Oct 18, 2011
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT
DS DP U-3
N021093 002 5196444
Jun 04, 2012
5196444*PED
Dec 04, 2012
DP
5534534
Jul 09, 2013
5534534*PED
Jan 09, 2014
5705517*PED
Oct 18, 2011
DP U-3
5721263
Feb 24, 2015
DP U-3
5958961
Jun 06, 2014
7538133*PED
Oct 18, 2011
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT
DS DP U-3
N021093 003 5196444
Jun 04, 2012
5196444*PED
Dec 04, 2012
DP
5534534
Jul 09, 2013
5534534*PED
Jan 09, 2014
5705517*PED
Oct 18, 2011
DP U-3
5721263
Feb 24, 2015
DP U-3
5958961
Jun 06, 2014
7538133*PED
Oct 18, 2011
CAPECITABINE - XELODA
N020896 001 5472949

Dec

14, 2013

U-271

CAPECITABINE - XELODA
N020896 002 5472949

Dec

14, 2013

U-271

CAPSAICIN - QUTENZA
N022395 001 6239180

Nov

06, 2016

DP

CARBAMAZEPINE - CARBAMAZEPINE
A076697 003
CARBAMAZEPINE - CARBATROL
N020712 001 5326570
5912013

Jul
Jun

23, 2011
15, 2016

U-215
U-277

CARBAMAZEPINE - CARBATROL
N020712 002 5326570
5912013

Jul
Jun

23, 2011
15, 2016

U-215
U-277

CARBAMAZEPINE - CARBATROL
N020712 003 5326570
5912013

Jul
Jun

23, 2011
15, 2016

U-215
U-277

CARBAMAZEPINE - EQUETRO
N021710 001 5326570
5912013
6977253

Jul
Jun
May

23, 2011
15, 2016
19, 2024

DP
DP

CARBAMAZEPINE - EQUETRO
N021710 002 5326570
5912013
6977253

Jul
Jun
May

23, 2011
15, 2016
19, 2024

DP
DP

CARBAMAZEPINE - EQUETRO
N021710 003 5326570
5912013
6977253

Jul
Jun
May

23, 2011
15, 2016
19, 2024

DP
DP

U-627
U-693

U-627
U-693

U-627
U-693

NCE
ODE

Nov
Nov

16, 2014
16, 2016

PC

Nov

16, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 28 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 100

N021485 002 5446194
Oct 19, 2013
6500867
Jun 29, 2020
6797732
Jun 29, 2020

DS

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 125

N021485 006 5446194
Oct 19, 2013
6500867
Jun 29, 2020
6797732
Jun 29, 2020

DS

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 150

N021485 003 5446194
Oct 19, 2013
6500867
Jun 29, 2020
6797732
Jun 29, 2020

DS

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 200

N021485 004 5446194
Oct 19, 2013
6500867
Jun 29, 2020
6797732
Jun 29, 2020

DS

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 50

N021485 001 5446194
Oct 19, 2013
6500867
Jun 29, 2020
6797732
Jun 29, 2020

DS

CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 75

N021485 005 5446194
Oct 19, 2013
6500867
Jun 29, 2020
6797732
Jun 29, 2020

DS

DP
DP

U-219

DP
DP

U-219

DP
DP

U-219

DP
DP

U-219

DP
DP

U-219

DP
DP

U-219

CARGLUMIC ACID - CARBAGLU

N022562 001

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

NCE
ODE

CARVEDILOL - COREG
N020297 001 RE40000
RE40000*PED

Jun
Dec

07, 2015
07, 2015

U-233

CARVEDILOL - COREG
N020297 002 RE40000
RE40000*PED

Jun
Dec

07, 2015
07, 2015

U-233

CARVEDILOL - COREG
N020297 003 RE40000
RE40000*PED

Jun
Dec

07, 2015
07, 2015

U-233

CARVEDILOL - COREG
N020297 004 RE40000
RE40000*PED

Jun
Dec

07, 2015
07, 2015

U-233

07,
07,
07,
17,
17,
27,
27,
27,
07,
07,

U-313
U-777

CARVEDILOL PHOSPHATE - COREG CR

Feb
N022012 001 5902821
Feb
5902821
Aug
5902821*PED
Oct
6022562
Apr
6022562*PED
Jun
7268156
Jun
7268156
Dec
7268156*PED
Jun
RE40000
Dec
RE40000*PED

2016
2016
2016
2015
2016
2023
2023
2023
2015
2015

DP
DS
DS

DP
DP

U-313
U-3
U-777

EXCLUSIVITY
EXPIRATION
DATE

Mar
Mar

18, 2015
18, 2017

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 29 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

CARVEDILOL PHOSPHATE - COREG CR

Feb
N022012 002 5902821
Feb
5902821
Aug
5902821*PED
Oct
6022562
Apr
6022562*PED
Jun
7268156
Jun
7268156
Dec
7268156*PED
Jun
RE40000
Dec
RE40000*PED

07,
07,
07,
17,
17,
27,
27,
27,
07,
07,

2016
2016
2016
2015
2016
2023
2023
2023
2015
2015

CARVEDILOL PHOSPHATE - COREG CR

Feb
N022012 003 5902821
Feb
5902821
Aug
5902821*PED
Oct
6022562
Apr
6022562*PED
Jun
7268156
Jun
7268156
Dec
7268156*PED
Jun
RE40000
Dec
RE40000*PED

07,
07,
07,
17,
17,
27,
27,
27,
07,
07,

2016
2016
2016
2015
2016
2023
2023
2023
2015
2015

CARVEDILOL PHOSPHATE - COREG CR

Feb
N022012 004 5902821
Feb
5902821
Aug
5902821*PED
Oct
6022562
Apr
6022562*PED
Jun
7268156
Jun
7268156
Dec
7268156*PED
Jun
RE40000
Dec
RE40000*PED

07,
07,
07,
17,
17,
27,
27,
27,
07,
07,

2016
2016
2016
2015
2016
2023
2023
2023
2015
2015

CASPOFUNGIN ACETATE - CANCIDAS

N021227 001 5378804
5378804*PED
5514650
5514650*PED
5792746
5792746*PED
5952300
5952300*PED
6136783
6136783*PED

Mar
Sep
Jan
Jul
Mar
Sep
Mar
Sep
Mar
Sep

16,
16,
26,
26,
16,
16,
28,
28,
28,
28,

2013
2013
2015
2015
2013
2013
2017
2017
2017
2017

DS

CASPOFUNGIN ACETATE - CANCIDAS

N021227 002 5378804
5378804*PED
5514650
5514650*PED
5792746
5792746*PED
5952300
5952300*PED
6136783
6136783*PED

Mar
Sep
Jan
Jul
Mar
Sep
Mar
Sep
Mar
Sep

16,
16,
26,
26,
16,
16,
28,
28,
28,
28,

2013
2013
2015
2015
2013
2013
2017
2017
2017
2017

DS

CEFDINIR - OMNICEF
N050739 001 4935507

Dec

04, 2011

DS

CEFDINIR - OMNICEF
N050749 001 4935507

Dec

04, 2011

DS

CEFDINIR - OMNICEF
N050749 002 4935507

Dec

04, 2011

DS

U-313
U-777
DP
DS
DS

DP
DP

U-3
U-313
U-777

U-777
U-313
DP
DS
DS

DP
DP

U-313
U-3
U-777

U-777
U-313
DP
DS
DS

DP
DP

U-313
U-3
U-777

DS

DP

U-607

DP

U-607

DP
U-607

DS

DP

U-607

DP

U-607

DP
U-607

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 30 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

CEFDITOREN PIVOXIL - SPECTRACEF

N021222 001 5958915
Oct

14, 2016

CEFDITOREN PIVOXIL - SPECTRACEF

N021222 002 5958915
Oct

14, 2016

CEFTAROLINE FOSAMIL - TEFLARO

N200327 001 6417175
6906055
7419973

Dec
Dec
Dec

17, 2018
15, 2021
15, 2021

DS
DS

DP
DP
DP

U-282

NCE

Oct

29, 2015

CEFTAROLINE FOSAMIL - TEFLARO

N200327 002 6417175
6906055
7419973

Dec
Dec
Dec

17, 2018
15, 2021
15, 2021

DS
DS

DP
DP
DP

U-282

NCE

Oct

29, 2015

CEFTIBUTEN DIHYDRATE - CEDAX

N050685 002 5599557

Apr

30, 2013

DP

CEFTIBUTEN DIHYDRATE - CEDAX

N050686 001 5599557
5599557

Feb
Feb

04, 2014
04, 2014

DP
DP

U-282
U-578

CEFTIBUTEN DIHYDRATE - CEDAX

N050686 002 5599557
5599557

Feb
Feb

04, 2014
04, 2014

DP
DP

U-578
U-282

CELECOXIB - CELEBREX
N020998 001 5466823
5466823*PED
5563165
5563165*PED
5760068
5760068*PED

Nov
May
Nov
May
Jun
Dec

30,
30,
30,
30,
02,
02,

2013
2014
2013
2014
2015
2015

DS

CELECOXIB - CELEBREX
N020998 002 5466823
5466823*PED
5563165
5563165*PED
5760068
5760068*PED

Nov
May
Nov
May
Jun
Dec

30,
30,
30,
30,
02,
02,

2013
2014
2013
2014
2015
2015

DS

CELECOXIB - CELEBREX
N020998 003 5466823
5466823*PED
5563165
5563165*PED
5760068
5760068*PED

Nov
May
Nov
May
Jun
Dec

30,
30,
30,
30,
02,
02,

2013
2014
2013
2014
2015
2015

DS

CELECOXIB - CELEBREX
N020998 004 5466823
5466823*PED
5563165
5563165*PED
5760068
5760068*PED

Nov
May
Nov
May
Jun
Dec

30,
30,
30,
30,
02,
02,

2013
2014
2013
2014
2015
2015

DS

CERIVASTATIN SODIUM - BAYCOL

N020740 001 5177080

Nov

26, 2011

CERIVASTATIN SODIUM - BAYCOL

N020740 002 5177080

Nov

26, 2011

CERIVASTATIN SODIUM - BAYCOL

N020740 003 5177080

Nov

26, 2011

CERIVASTATIN SODIUM - BAYCOL

N020740 004 5177080

Nov

26, 2011

DP

DP
U-672

DP
U-672

DP
U-672

DP
U-672

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 31 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

CERIVASTATIN SODIUM - BAYCOL

N020740 005 5177080

PATENT
EXPIRATION
DATE

Nov

PATENT
CODES

PATENT
DELIST
REQUESTED

26, 2011

CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY

DP
N021621 003 6455533
Jul 02, 2018

U-295

CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY

DP
N021621 004 6455533
Jul 02, 2018

U-295

CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF

DP U-295
N021621 005 6455533
Jul 02, 2018
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF
DP U-295
N021621 006 6455533
Jul 02, 2018
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ZYRTEC-D 12 HOUR
Jul 13, 2019
DP U-295
N021150 002 6469009
DP
Apr 08, 2016
6489329
DP
Jun 10, 2022
7014867
U-295
Jun 10, 2022
7226614
CETRORELIX - CETROTIDE
N021197 001 6319192
6863891
7605121

Apr
Feb
Feb

23, 2019
22, 2014
22, 2014

CETRORELIX - CETROTIDE
N021197 002 6319192
6863891
7605121

Apr
Feb
Feb

23, 2019
22, 2014
22, 2014

CEVIMELINE HYDROCHLORIDE - EVOXAC

N020989 002 5340821
Jul

07, 2013

CHLORHEXIDINE GLUCONATE - CHLORHEXIDINE GLUCONATE

N021669 001 7066916
Feb 17, 2024
7427574
Apr 25, 2026
May 12, 2023
7595021
Oct 02, 2027
7935093

U-426
U-426
DP

U-426
U-426
DP

U-309

U-737
DP
DP
DP

U-1022
U-1022

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP

Sep 30, 2016
DP
N020832 001 5690958
DP
Nov 10, 2020
6536975
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP
Sep 30, 2016
DP
N020832 004 5690958
DP
Nov 10, 2020
6536975
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP
N020832 006 5690958
Sep 30, 2016
DP
DP
6991394
Jan 31, 2024
DP
7182536
Dec 30, 2023
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP FREPP
Aug 25, 2015
DP
N020832 003 5538353
DP
Sep 30, 2016
5690958
DP
Apr 22, 2017
5752363
Apr 22, 2017
DP
5772346
DP
Nov 25, 2011
D386849
DP
Aug 11, 2012
D396911
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP SEPP
N021555 001 5690958
Sep 30, 2016
DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT
N020832 002 5690958
Sep 30, 2016
DP
6729786
Mar 14, 2023
DP
DP
6991393
Mar 14, 2023
DP
6991394
Jan 31, 2024
DP
7182536
Dec 30, 2023
DP
7241065
Mar 14, 2023

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 32 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT

DP
N020832 005 5690958
Sep 30, 2016
Nov 10, 2020
DP
6536975
DP
Mar 14, 2023
6729786
DP
Jan 31, 2024
6991393
DP
Mar 14, 2023
7241065
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT
DP
N020832 007 5690958
Sep 30, 2016
Nov 10, 2020
DP
6536975
Mar 14, 2023
DP
6729786
DP
Mar 14, 2023
6991393
DP
Mar 14, 2023
7241065
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORASCRUB MAXI SWABSTICK
N021524 003 D468424
Jan 07, 2017
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - ADVIL ALLERGY SINUS
DP
N021441 001 7863287
Feb 28, 2027
CHOLINE FENOFIBRATE - TRILIPIX
N022224 001 7259186
Jan

07, 2025

DS

NP

Dec

15, 2011

CHOLINE FENOFIBRATE - TRILIPIX

N022224 002 7259186
Jan

07, 2025

DS

NP

Dec

15, 2011

CHORIOGONADOTROPIN ALFA - OVIDREL

N021149 001 5767251
Jun

16, 2015

CHORIOGONADOTROPIN ALFA - OVIDREL

N021149 002 5767251
Jun
6706681
Mar

16, 2015
16, 2021

DS

CICLESONIDE - ALVESCO
N021658 002 5482934
5605674
5683677
5775321
6006745
6036942
6120752
6264923

Oct
Feb
Nov
Jul
Dec
Apr
May
May

24,
25,
04,
07,
28,
30,
13,
13,

2017
2014
2014
2015
2016
2013
2018
2018

DS

DP
DP
DP
DP
DP
DP
DP
DP

U-1002

NCE

Oct

20, 2011

CICLESONIDE - ALVESCO
N021658 003 5482934
5605674
5683677
5775321
6006745
6036942
6120752
6264923

Oct
Feb
Nov
Jul
Dec
Apr
May
May

24,
25,
04,
07,
28,
30,
13,
13,

2017
2014
2014
2015
2016
2013
2018
2018

DS

DP
DP
DP
DP
DP
DP
DP
DP

U-1002

NCE

Oct

20, 2011

CICLESONIDE - OMNARIS
N022004 001 5482934
6767901
6939559
7235247

Oct
Oct
Apr
Apr

24,
21,
21,
21,

2017
2020
2019
2019

DS

DP
DP
DP
DP

U-557

NCE

Oct

20, 2011

CICLOPIROX - LOPROX
N020519 001 7018656
7026337

Sep
Nov

05, 2018
21, 2016

CICLOPIROX - LOPROX
N021159 001 7981909

Sep

16, 2017

DP

DP

U-714

U-1162

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 33 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

CINACALCET HYDROCHLORIDE - SENSIPAR

N021688 001 6011068
Mar 08, 2018
6031003
Dec 14, 2016
6211244
Oct 23, 2015
6313146
Dec 14, 2016
7829595
Sep 22, 2026
CINACALCET HYDROCHLORIDE - SENSIPAR
N021688 002 6011068
Mar 08, 2018
6031003
Dec 14, 2016
6211244
Oct 23, 2015
6313146
Dec 14, 2016
7829595
Sep 22, 2026
CINACALCET HYDROCHLORIDE - SENSIPAR
N021688 003 6011068
Mar 08, 2018
6031003
Dec 14, 2016
6211244
Oct 23, 2015
6313146
Dec 14, 2016
7829595
Sep 22, 2026
CIPROFLOXACIN - CIPRO
N020780 001 5695784
5695784*PED
6136347
6136347*PED

Dec
Jun
Jan
Jul

09,
09,
06,
06,

2014
2015
2013
2013

CIPROFLOXACIN - CIPRO
N020780 002 5695784
5695784*PED
6136347
6136347*PED

Dec
Jun
Jan
Jul

09,
09,
06,
06,

2014
2015
2013
2013

PATENT
CODES
DS

DP
U-559
U-560

DS
DS

DP
DP

DP U-1098

DS

DP

DS
DS

DP U-560
DP

DP U-1098

DS

DP

DS
DS

U-559
U-560

DP
DP

DP U-1098

EXCLUSIVITY
EXPIRATION
DATE

I-634
M-101
ODE

Feb
Feb
Feb

25, 2014
25, 2014
25, 2018

I-634
M-101
ODE

Feb
Feb
Feb

25, 2014
25, 2014
25, 2018

I-634
M-101
ODE

Feb
Feb
Feb

25, 2014
25, 2014
25, 2018

NDF

May

01, 2012

U-362

CIPROFLOXACIN HYDROCHLORIDE - CIPRO

N019537 001 5286754*PED
Aug 15, 2011
CIPROFLOXACIN HYDROCHLORIDE - CIPRO
N019537 002 5286754*PED
Aug 15, 2011
CIPROFLOXACIN HYDROCHLORIDE - CIPRO
N019537 003 5286754*PED
Aug 15, 2011
CIPROFLOXACIN HYDROCHLORIDE - CIPRO
N019537 004 5286754*PED
Aug 15, 2011

DP
DP
DP
DP

U-663
U-663
U-663

CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE - CIPRO HC

U-646
N020805 001 5843930
Jun 06, 2015
DP
5965549
Jun 06, 2015
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR
DP
N021473 001 7709022
Jun 23, 2021
7709022*PED
Dec 23, 2021
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR
DP
N021473 002 7709022
Jun 23, 2021
7709022*PED
Dec 23, 2021
CIPROFLOXACIN; DEXAMETHASONE - CIPRODEX
N021537 001 6284804
Aug 10, 2020
6359016
Aug 10, 2020

EXCLUSIVITY
CODE(S)

U-362

CIPROFLOXACIN HYDROCHLORIDE - CETRAXAL

N021918 001

CIPROFLOXACIN HYDROCHLORIDE - PROQUIN XR

N021744 001 5972389
Sep 19, 2016
6340475
Sep 19, 2016
6488962
Jun 20, 2020
6635280
Sep 19, 2016

PATENT
DELIST
REQUESTED

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 34 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

CISAPRIDE MONOHYDRATE - PROPULSID QUICKSOLV

N020767 001 5648093
Jul 15, 2014
CISATRACURIUM BESYLATE - NIMBEX
Sep
N020551 001 5453510

26, 2012

U-127

CISATRACURIUM BESYLATE - NIMBEX PRESERVATIVE FREE

N020551 002 5453510
Sep 26, 2012

U-127

CISATRACURIUM BESYLATE - NIMBEX PRESERVATIVE FREE

N020551 003 5453510
Sep 26, 2012

U-127

CLARITHROMYCIN - BIAXIN XL
N050775 001 6010718
6551616

Apr
Jul

11, 2017
15, 2017

DP

U-924
U-924

CLEVIDIPINE BUTYRATE - CLEVIPREX

N022156 001 5739152
Apr
5856346
Jan

14, 2015
05, 2016

DP
DP

U-893
U-893

NCE

Aug

01, 2013

DS

CLEVIDIPINE BUTYRATE - CLEVIPREX

N022156 002 5739152
Apr
5856346
Jan

14, 2015
05, 2016

DP
DP

U-893
U-893

NCE

Aug

01, 2013

DS

CLINDAMYCIN PHOSPHATE - CLEOCIN

N050767 001 6495157
Jul

20, 2020

DP

CLINDAMYCIN PHOSPHATE - CLINDAGEL

N050782 001 6387383
Aug

03, 2020

DP

U-818

CLINDAMYCIN PHOSPHATE - CLINDESSE

N050793 001 5993856
Nov
6899890
Apr

17, 2017
27, 2023

DP
DP

U-137
U-137

CLINDAMYCIN PHOSPHATE - EVOCLIN

N050801 001 7141237
Jan
7374747
Aug

23, 2024
09, 2026

DP
DP

U-921

NCE
ODE

Oct
Oct

21, 2016
21, 2018

NCE
ODE

Oct
Oct

21, 2016
21, 2018

NCE
ODE

Oct
Oct

21, 2016
21, 2018

DS
DS

CLINDAMYCIN PHOSPHATE; TRETINOIN - VELTIN

N050803 001 5690923
Nov 25, 2014

DP

CLINDAMYCIN PHOSPHATE; TRETINOIN - ZIANA

N050802 001 6387383
Aug 03, 2020
RE41134
Feb 24, 2015

DP
DP

U-916
U-1033

CLOBAZAM - ONFI
N202067 001
CLOBAZAM - ONFI
N202067 002
CLOBAZAM - ONFI
N202067 003
CLOBETASOL PROPIONATE - CLOBEX
Sep
N021535 001 6106848

22, 2017

CLOBETASOL PROPIONATE - CLOBEX

N021644 001 7316810
Jun
7700081
Jan
8066975
Jun
8066976
Jun

17,
03,
17,
17,

2019
2022
2019
2019

DP

CLOBETASOL PROPIONATE - CLOBEX

N021835 001 5972920
Feb
5990100
Mar

12, 2018
24, 2018

DP
DP

U-1044
DP
DP

U-742

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 35 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

CLOBETASOL PROPIONATE - OLUX

N021142 001 6126920

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-484

Mar

01, 2016

CLOBETASOL PROPIONATE - OLUX E

Sep
N022013 001 6730288
Sep
7029659

08, 2019
08, 2019

CLOFARABINE - CLOLAR
N021673 001 5661136
5661136*PED

Jan
Jul

14, 2018
14, 2018

CLONIDINE HYDROCHLORIDE - JENLOGA

N022331 001 5869100
Oct

13, 2013

DP

CLONIDINE HYDROCHLORIDE - JENLOGA

N022331 002 5869100
Oct

13, 2013

DP

CLONIDINE HYDROCHLORIDE - KAPVAY

N022331 003 5869100
Oct

13, 2013

CLONIDINE HYDROCHLORIDE - KAPVAY

N022331 004 5869100
Oct

13, 2013

CLOPIDOGREL BISULFATE - PLAVIX

N020839 001 4847265
4847265*PED
5576328
5576328*PED
6429210
6429210*PED
6504030
6504030*PED

Nov
May
Jan
Jul
Jun
Dec
Jun
Dec

17,
17,
31,
31,
10,
10,
10,
10,

2011
2012
2014
2014
2019
2019
2019
2019

DS

CLOPIDOGREL BISULFATE - PLAVIX

N020839 002 4847265
4847265*PED
6429210
6429210*PED
6504030
6504030*PED

Nov
May
Jun
Dec
Jun
Dec

17,
17,
10,
10,
10,
10,

2011
2012
2019
2019
2019
2019

DS

DP

DS

DP

CLOZAPINE - FAZACLO ODT

N021590 001 6024981
6106861
6221392

Apr
Dec
Apr

09, 2018
05, 2017
09, 2018

DP
DP
DP

CLOZAPINE - FAZACLO ODT

N021590 002 6024981
6106861
6221392

Apr
Dec
Apr

09, 2018
05, 2017
09, 2018

DP
DP
DP

CLOZAPINE - FAZACLO ODT

N021590 003 6024981
6106861
6221392

Apr
Dec
Apr

09, 2018
05, 2017
09, 2018

DP
DP
DP

CLOZAPINE - FAZACLO ODT

N021590 004 6024981
6106861
6221392

Apr
Dec
Apr

09, 2018
05, 2017
09, 2018

DP
DP
DP

CLOZAPINE - FAZACLO ODT

N021590 005 6024981
6106861
6221392

Apr
Dec
Apr

09, 2018
05, 2017
09, 2018

DP
DP
DP

CLOZAPINE - FAZACLO ODT

N021590 006 6024981
6106861
6221392

Apr
Dec
Apr

09, 2018
05, 2017
09, 2018

DP
DP
DP

DP
DP

U-626

ODE
PED

Dec
Jun

28, 2011
28, 2012

NP

Sep

29, 2012

DP

NP

Sep

28, 2013

DP

NP

Sep

28, 2013

DP

M-61
PED

May
Nov

06, 2014
06, 2014

M-61
PED

May
Nov

06, 2014
06, 2014

U-432
DS

DP

DS

DS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 36 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

COLCHICINE - COLCRYS
N022352 001 7601758
7619004
7820681
7906519
7915269
7935731
7964647
7964648
7981938
8093296
8093297
8093298

PATENT
EXPIRATION
DATE

Feb
Dec
Feb
Feb
Feb
Dec
Oct
Feb
Oct
Oct
Oct
Oct

10,
03,
17,
17,
17,
03,
06,
17,
06,
06,
06,
06,

PATENT
CODES
U-1007
U-1020
U-1020
U-1116
U-1007
U-1116
U-1007
U-1161
U-1166
U-1007
U-1161
U-1116

2029
2028
2029
2029
2029
2028
2028
2029
2028
2028
2028
2028

COLESEVELAM HYDROCHLORIDE - WELCHOL

Jun 10, 2014
N021141 001 5607669
Dec 10, 2014
5607669*PED
Apr 29, 2014
5679717
Oct 29, 2014
5679717*PED
Dec 02, 2014
5693675
Jun 02, 2015
5693675*PED
Apr 29, 2014
5917007
Oct 29, 2014
5917007*PED
Jun 10, 2014
5919832
Dec 10, 2014
5919832*PED
Jun 10, 2014
6066678
Dec 10, 2014
6066678*PED
Jun 10, 2014
6433026
Dec 10, 2014
6433026*PED
COLESEVELAM HYDROCHLORIDE - WELCHOL
Jun 10, 2014
N021176 001 5607669
Dec 10, 2014
5607669*PED
Apr 29, 2014
5679717
Oct 29, 2014
5679717*PED
Dec 02, 2014
5693675
Jun 02, 2015
5693675*PED
Apr 29, 2014
5917007
Oct 29, 2014
5917007*PED
Apr 29, 2014
5919832
Oct 29, 2014
5919832*PED
Apr 29, 2014
6066678
Oct 29, 2014
6066678*PED
Apr 29, 2014
6433026
Oct 29, 2014
6433026*PED
Apr 29, 2014
6784254
Oct 29, 2014
6784254*PED
Apr 29, 2014
7101960
Oct 29, 2014
7101960*PED
Apr 17, 2022
7229613
Oct 17, 2022
7229613*PED

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-603
ODE

Jul
Jul

30, 2012
29, 2016

I-608
PED
PED

Oct
Apr
Jul

02, 2012
02, 2013
18, 2011

U-323
U-323

U-323

U-323

U-323
U-323
DS
DS

U-323

DS
DS

U-323

DS
DS

DP

DS

DP

U-757
U-851

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 37 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

COLESEVELAM HYDROCHLORIDE - WELCHOL

N022362 001 5607669
Jun 10, 2014
5607669*PED
Dec 10, 2014
5679717
Apr 29, 2014
5679717*PED
Oct 29, 2014

5693675
Dec 02, 2014
5693675*PED
Jun 02, 2015

5917007
Apr 29, 2014
5917007*PED
Oct 29, 2014

5919832
Apr 29, 2014
5919832*PED
Oct 29, 2014

6066678
Apr 29, 2014
6066678*PED
Oct 29, 2014

6433026
Apr 29, 2014
6433026*PED
Oct 29, 2014

6784254
Apr 29, 2014
6784254*PED
Oct 29, 2014

7101960
Apr 29, 2014
7101960*PED
Oct 29, 2014

7229613
Apr 17, 2022
7229613*PED
Oct 17, 2022

COLESEVELAM HYDROCHLORIDE - WELCHOL

N022362 002 5607669
Jun 10, 2014
5607669*PED
Dec 10, 2014
5679717
Apr 29, 2014
5679717*PED
Oct 29, 2014

5693675
Dec 02, 2014
5693675*PED
Jun 02, 2015

5917007
Apr 29, 2014
5917007*PED
Oct 29, 2014

5919832
Apr 29, 2014
5919832*PED
Oct 29, 2014

6066678
Apr 29, 2014
6066678*PED
Oct 29, 2014

6433026
Apr 29, 2014
6433026*PED
Oct 29, 2014

6784254
Apr 29, 2014
6784254*PED
Oct 29, 2014

7101960
Apr 29, 2014
7101960*PED
Oct 29, 2014

7229613
Apr 17, 2022
7229613*PED
Oct 17, 2022

PATENT
CODES
U-757

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-608
PED
PED

Oct
Apr
Jul

02, 2012
02, 2013
18, 2011

I-608
PED
PED

Oct
Apr
Jul

02, 2012
02, 2013
18, 2011

ODE

Oct

15, 2017

U-1179

NCE
ODE

Aug
Aug

26, 2016
26, 2018

U-1179

NCE
ODE

Aug
Aug

26, 2016
26, 2018

U-757
DS

U-757

DS
DS

U-757

DS
DS

DS

DP

DS

DP

U-757

U-493

U-757
U-757
DS

U-757

DS
DS

U-757

DS
DS

DS

DP

DS

DP

U-757

U-493

COLESTIPOL HYDROCHLORIDE - COLESTID

N020222 001 5490987
Feb 13, 2013
CONIVAPTAN HYDROCHLORIDE - VAPRISOL
N021697 001 5723606
Dec 15, 2019
5723606
Dec 15, 2019

PATENT
DELIST
REQUESTED

DP

DS
DS

DP
DP

U-868
U-698

CONIVAPTAN HYDROCHLORIDE - VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER

N021697 002 5723606
Dec 15, 2019
DS DP U-698
DS DP U-868
5723606
Dec 15, 2019
CORTICOTROPIN - H.P. ACTHAR GEL
N008372 008
CRIZOTINIB - XALKORI
N202570 001 7230098
7825137
7858643

Mar
May
Oct

01, 2025
12, 2027
08, 2029

DS

CRIZOTINIB - XALKORI
N202570 002 7230098
7825137
7858643

Mar
May
Oct

01, 2025
12, 2027
08, 2029

DS

DS

DS

DP

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 38 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

CYANOCOBALAMIN - NASCOBAL
N021642 001 7229636
7404489
7879349

PATENT
EXPIRATION
DATE

Jun
Mar
Jun

PATENT
CODES
DP
DP
DP

11, 2024
12, 2024
01, 2024

CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX

N021777 001 7387793
Feb 26,
7544372
Nov 14,
7790199
Nov 14,
7820203
Nov 14,
7829121
Nov 14,

2025
2023
2023
2023
2023

DP

CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX

N021777 002 7387793
Feb 26,
7544372
Nov 14,
7790199
Nov 14,
7820203
Nov 14,
7829121
Nov 14,

2025
2023
2023
2023
2023

DP

CYCLOSPORINE - NEORAL
N050715 001 5342625
5741512
5985321
6258808
6262022

Aug
Aug
Sep
Jun
Jun

30,
30,
26,
25,
25,

2011
2011
2014
2012
2012

DP
DP
DP
DP
DP

CYCLOSPORINE - NEORAL
N050715 002 5342625
5741512
5985321
6258808
6262022

Aug
Aug
Sep
Jun
Jun

30,
30,
26,
25,
25,

2011
2011
2014
2012
2012

DP
DP
DP
DP
DP

CYCLOSPORINE - NEORAL
N050715 003 5342625
5741512
5985321
6258808
6262022

Aug
Aug
Sep
Jun
Jun

30,
30,
26,
25,
25,

2011
2011
2014
2012
2012

DP
DP
DP
DP
DP

CYCLOSPORINE - NEORAL
N050716 001 5342625
5741512
5985321
6258808
6262022

Aug
Aug
Sep
Jun
Jun

30,
30,
26,
25,
25,

2011
2011
2014
2012
2012

DP
DP
DP
DP
DP

CYCLOSPORINE - RESTASIS
N050790 001 5474979

May

17, 2014

DP

CYTARABINE - DEPOCYT
N021041 001 5455044
5723147

May
Mar

14, 2013
03, 2015

DP

U-817
U-1152

U-1088

U-979
DP
DP
U-1088

DABIGATRAN ETEXILATE MESYLATE - PRADAXA

N022512 002 6087380
Feb 18, 2018
7866474
Aug 31, 2027
Sep 07, 2025
7932273

DS

06, 2011
30, 2013
26, 2027

EXCLUSIVITY
EXPIRATION
DATE

U-979

DS

Dec
Jul
May

EXCLUSIVITY
CODE(S)

DP
DP

DABIGATRAN ETEXILATE MESYLATE - PRADAXA

N022512 001 6087380
Feb 18, 2018
7866474
Aug 31, 2027
Sep 07, 2025
7932273

DALFAMPRIDINE - AMPYRA
N022250 001 5370879
5540938
8007826

PATENT
DELIST
REQUESTED

DS

DS

U-906

U-906

U-906

U-906

U-806
U-806

DP
DP
DP

U-1089

NCE

Oct

19, 2015

DP
DP
DP

U-1089

NCE

Oct

19, 2015

NCE
ODE

Jan
Jan

22, 2015
22, 2017

DP
U-1030
U-1030

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 39 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DAPSONE - ACZONE
N021794 001 5863560
6060085
6620435

Sep
Sep
Sep

11, 2016
11, 2016
11, 2016

DAPTOMYCIN - CUBICIN
N021572 001 6468967
6852689
8058238

Sep
Sep
Nov

24, 2019
24, 2019
28, 2020

DAPTOMYCIN - CUBICIN
N021572 002 6468967
6852689
8003673
8058238
RE39071

Sep
Sep
Sep
Nov
Jun

24,
24,
04,
28,
15,

2019
2019
2028
2020
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
DS

DP
DP

U-728

DARIFENACIN HYDROBROMIDE - ENABLEX

N021513 001 5096890
Mar
6106864
Aug

13, 2015
21, 2016

DS

DP
DP

U-631
U-630

DARIFENACIN HYDROBROMIDE - ENABLEX

Mar
N021513 002 5096890
Aug
6106864

13, 2015
21, 2016

DS

DP
DP

U-631
U-630

DARUNAVIR ETHANOLATE - PREZISTA

Dec
N021976 001 5843946
Dec
5843946
Dec
5843946
Jun
5843946*PED
Jun
6037157
Dec
6037157*PED
Aug
6248775
Feb
6248775*PED
Aug
6335460
Aug
6335460
Aug
6335460
Feb
6335460*PED
Jun
6703403
Dec
6703403*PED
Jun
7470506
Dec
7470506*PED
Dec
7700645
Jun
7700645*PED
Oct
RE42889
Apr
RE42889*PED

01,
01,
01,
01,
26,
26,
13,
13,
25,
25,
25,
25,
26,
26,
23,
23,
26,
26,
19,
19,

2015
2015
2015
2016
2016
2016
2014
2015
2012
2012
2012
2013
2016
2016
2019
2019
2026
2027
2016
2017

DP
DP
DP

U-744
U-903
U-935

DARUNAVIR ETHANOLATE - PREZISTA

N021976 002 5843946
Dec
5843946
Dec
5843946
Dec
5843946*PED
Jun
6037157
Jun
6037157*PED
Dec
6248775
Aug
Feb
6248775*PED
Aug
6335460
Aug
6335460
Aug
6335460
Feb
6335460*PED
Jun
6703403
Dec
6703403*PED
Jun
7470506
Dec
7470506*PED
Dec
7700645
Jun
7700645*PED
Oct
RE42889
Apr
RE42889*PED

01,
01,
01,
01,
26,
26,
13,
13,
25,
25,
25,
25,
26,
26,
23,
23,
26,
26,
19,
19,

2015
2015
2015
2016
2016
2016
2014
2015
2012
2012
2012
2013
2016
2016
2019
2019
2026
2027
2016
2017

U-935
DS
DS
DS
DS

DP
DP
DP

U-935
U-903
U-744

D-129
D-119
I-578
NPP
PED
PED
PED
PED
PED

Dec
Dec
Oct
Dec
Jun
Dec
Apr
Jun
Jun

13,
18,
21,
16,
16,
23,
21,
13,
18,

2013
2011
2011
2014
2015
2011
2012
2014
2012

D-129
D-119
I-578
NPP
PED
PED
PED
PED
PED

Dec
Dec
Oct
Dec
Jun
Dec
Apr
Jun
Jun

13,
18,
21,
16,
16,
23,
21,
13,
18,

2013
2011
2011
2014
2015
2011
2012
2014
2012

U-935
U-935
DS

DP
DP

DP
DP
DP

U-935
U-744
U-903
U-935

DS
DS
DS
DS

DP
DP
DP

U-744
U-903
U-935
U-935
U-935

DS

DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 40 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DARUNAVIR ETHANOLATE - PREZISTA

Dec
N021976 003 5843946
Dec
5843946
Dec
5843946
Jun
5843946*PED
Jun
6037157
Dec
6037157*PED
Aug
6248775
Feb
6248775*PED
Aug
6335460
Aug
6335460
Feb
6335460*PED
Jun
6703403
Dec
6703403*PED
Jun
7470506
Dec
7470506*PED
Dec
7700645
Jun
7700645*PED
Oct
RE42889
Apr
RE42889*PED

01,
01,
01,
01,
26,
26,
13,
13,
25,
25,
25,
26,
26,
23,
23,
26,
26,
19,
19,

2015
2015
2015
2016
2016
2016
2014
2015
2012
2012
2013
2016
2016
2019
2019
2026
2027
2016
2017

DARUNAVIR ETHANOLATE - PREZISTA

N021976 004 5843946
Dec
5843946*PED
Jun
6037157
Jun
6037157*PED
Dec
6248775
Aug
6248775*PED
Feb
6335460
Aug
6335460*PED
Feb
6703403
Jun
6703403*PED
Dec
7470506
Jun
7470506*PED
Dec
7700645
Dec
7700645*PED
Jun
RE42889
Oct
RE42889*PED
Apr

01,
01,
26,
26,
13,
13,
25,
25,
26,
26,
23,
23,
26,
26,
19,
19,

2015
2016
2016
2016
2014
2015
2012
2013
2016
2016
2019
2019
2026
2027
2016
2017

DARUNAVIR ETHANOLATE - PREZISTA

N021976 005 5843946
Dec
5843946*PED
Jun
6037157
Jun
6037157*PED
Dec
6248775
Aug
Feb
6248775*PED
Aug
6335460
Feb
6335460*PED
Jun
6703403
Dec
6703403*PED
Jun
7470506
Dec
7470506*PED
Dec
7700645
Jun
7700645*PED
Oct
RE42889
Apr
RE42889*PED

01,
01,
26,
26,
13,
13,
25,
25,
26,
26,
23,
23,
26,
26,
19,
19,

2015
2016
2016
2016
2014
2015
2012
2013
2016
2016
2019
2019
2026
2027
2016
2017

PATENT
CODES
DP
DP
DP

U-744
U-903
U-935
U-935

DS
DS
DS

DP
DP

U-935
U-903
U-935

Jun
Jun
Apr
Apr
Apr
Mar

28,
28,
13,
13,
28,
28,

2020
2020
2020
2020
2020
2026

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

D-129
D-119
D-118
I-578
NPP
PED
PED
PED
PED
PED
PED

Dec
Dec
Oct
Oct
Dec
Jun
Dec
Apr
Jun
Jun
Apr

13,
18,
21,
21,
16,
16,
23,
21,
18,
13,
21,

2013
2011
2011
2011
2014
2015
2011
2012
2012
2014
2012

D-129
D-119
NPP
NS
PED
PED
PED
PED
PED

Dec
Dec
Dec
Dec
Jun
Dec
Jun
Jun
Jun

13,
18,
16,
18,
16,
23,
18,
13,
18,

2013
2011
2014
2011
2015
2011
2012
2014
2012

D-129
D-119
NPP
NS
PED
PED
PED
PED
PED

Dec
Dec
Dec
Dec
Jun
Dec
Jun
Jun
Jun

13,
18,
16,
18,
16,
23,
18,
13,
18,

2013
2011
2014
2011
2015
2011
2012
2014
2012

NDF
PED

Dec
Jun

16, 2014
16, 2015

D-120
M-94
ODE
ODE

May
Oct
Jun
Jun

21,
28,
28,
28,

U-935
DS

DP
DP

DP

U-935
U-935

DS
DS

DP

U-935
U-935
U-935

DS

DP
DP

DP

U-935
U-935

DS
DS

DP

U-935
U-935
U-935

DS

DP
DP

DARUNAVIR ETHANOLATE - PREZISTA

N202895 001
DASATINIB - SPRYCEL
N021986 001 6596746
6596746
7125875
7125875
7153856
7491725

PATENT
DELIST
REQUESTED

DS
DS

DP
DP

DS

DP

U-780
U-748
U-780
U-779
U-780

2012
2013
2013
2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 41 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

DASATINIB - SPRYCEL
N021986 002 6596746
6596746
7125875
7125875
7153856
7491725

Jun
Jun
Apr
Apr
Apr
Mar

28,
28,
13,
13,
28,
28,

2020
2020
2020
2020
2020
2026

DS
DS

DP
DP

DS

DP

DASATINIB - SPRYCEL
N021986 003 6596746
6596746
7125875
7125875
7153856
7491725

Jun
Jun
Apr
Apr
Apr
Mar

28,
28,
13,
13,
28,
28,

2020
2020
2020
2020
2020
2026

DS
DS

DP
DP

DS

DP

DASATINIB - SPRYCEL
N021986 004 6596746
6596746
7125875
7125875
7153856
7491725

Jun
Jun
Apr
Apr
Apr
Mar

28,
28,
13,
13,
28,
28,

2020
2020
2020
2020
2020
2026

DS
DS

DP
DP

DS

DP

DASATINIB - SPRYCEL
N021986 005 6596746
6596746
7125875
7125875
7153856
7491725

Jun
Jun
Apr
Apr
Apr
Mar

28,
28,
13,
13,
28,
28,

2020
2020
2020
2020
2020
2026

DS
DS

DP
DP

DS

DP

DASATINIB - SPRYCEL
N021986 006 6596746
6596746
7125875
7125875
7153856
7491725

Jun
Jun
Apr
Apr
Apr
Mar

28,
28,
13,
13,
28,
28,

2020
2020
2020
2020
2020
2026

DS
DS

DP
DP

DS

DP

Apr
Jun

05, 2019
24, 2017

DS
DS

DP

DEFERASIROX - EXJADE
N021882 002 6465504
6596750

Apr
Jun

05, 2019
24, 2017

DS
DS

DP

DEFERASIROX - EXJADE
N021882 003 6465504
6596750

Apr
Jun

05, 2019
24, 2017

DS
DS

DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-780
U-748
U-780
U-779
U-780

D-120
M-94
ODE
ODE

May
Oct
Jun
Jun

21,
28,
28,
28,

2012
2013
2013
2013

U-780
U-748
U-780
U-779
U-780

D-120
M-94
ODE
ODE

May
Oct
Jun
Jun

21,
28,
28,
28,

2012
2013
2013
2013

U-780
U-748
U-779
U-780
U-780

D-120
M-94
ODE
ODE

May
Oct
Jun
Jun

21,
28,
28,
28,

2012
2013
2013
2013

U-748
U-780
U-780
U-779
U-780

D-120
M-94
ODE
ODE

May
Oct
Jun
Jun

21,
28,
28,
28,

2012
2013
2013
2013

U-748
U-780
U-780
U-779
U-780

D-120
M-94
ODE
ODE

May
Oct
Jun
Jun

21,
28,
28,
28,

2012
2013
2013
2013

D-123
ODE

Mar
May

11, 2013
02, 2013

ODE

Nov

02, 2012

ODE

Nov

02, 2012

ODE

Nov

02, 2012

NCE
ODE

Oct
Oct

14, 2016
14, 2018

DECITABINE - DACOGEN
N021790 001
DEFERASIROX - EXJADE
N021882 001 6465504
6596750

PATENT
DELIST
REQUESTED

U-735

U-735

U-735

DEFERIPRONE - FERRIPROX
N021825 001
DEGARELIX ACETATE - FIRMAGON
N022201 001 5925730

Apr

11, 2017

DS

DP

U-943

NCE

Dec

24, 2013

DEGARELIX ACETATE - FIRMAGON

N022201 002 5925730

Apr

11, 2017

DS

DP

U-943

NCE

Dec

24, 2013

DELAVIRDINE MESYLATE - RESCRIPTOR

N020705 001 5563142
Oct

08, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 42 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

DELAVIRDINE MESYLATE - RESCRIPTOR

N020705 002 5563142
Oct
6177101
Jun

08, 2013
07, 2019

DESFLURANE - SUPRANE
N020118 001 5617906
5617906*PED

Apr
Oct

08, 2014
08, 2014

DESIRUDIN RECOMBINANT - IPRIVASK

N021271 001 5733874
Mar

31, 2015

DESLORATADINE - CLARINEX
N021165 001 6100274
6100274*PED
7211582
7211582*PED
7214683
7214683*PED
7214684
7214684*PED
7405223
7405223*PED

Jul
Jan
Dec
Jun
Dec
Jun
Dec
Jun
Jul
Jan

07,
07,
30,
30,
30,
30,
30,
30,
07,
07,

2019
2020
2014
2015
2014
2015
2014
2015
2019
2020

DESLORATADINE - CLARINEX
N021300 001 6514520
6514520*PED
7211582
7211582*PED
7214683
7214683*PED
7214684
7214684*PED

Jun
Dec
Dec
Jun
Dec
Jun
Dec
Jun

01,
01,
30,
30,
30,
30,
30,
30,

2018
2018
2014
2015
2014
2015
2014
2015

DP

DESLORATADINE - CLARINEX
N021312 001 5607697
5607697*PED
6100274
6100274*PED
7211582
7211582*PED
7214683
7214683*PED
7214684
7214684*PED
7618649
7618649*PED

Jun
Dec
Jul
Jan
Dec
Jun
Dec
Jun
Dec
Jun
Dec
Jun

07,
07,
07,
07,
30,
30,
30,
30,
30,
30,
19,
19,

2015
2015
2019
2020
2014
2015
2014
2015
2014
2015
2020
2021

DP

DESLORATADINE - CLARINEX
N021312 002 5607697
5607697*PED
6100274
6100274*PED
7211582
7211582*PED
7214683
7214683*PED
7214684
7214684*PED
7618649
7618649*PED

Jun
Dec
Jul
Jan
Dec
Jun
Dec
Jun
Dec
Jun
Dec
Jun

07,
07,
07,
07,
30,
30,
30,
30,
30,
30,
19,
19,

2015
2015
2019
2020
2014
2015
2014
2015
2014
2015
2020
2021

DP

DP

U-809
DP
U-138
U-886

U-809
DP
U-138

DP
U-809
DP
U-138
DP

U-1017

DP
U-809
DP
U-138
DP

U-1017

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 43 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

DESLORATADINE; PSEUDOEPHEDRINE SULFATE - CLARINEX D 24 HOUR

N021605 001 6100274
Jul 07, 2019
DP
6100274*PED
Jan 07, 2020
DP
6979463
Mar 28, 2022
DP
7214683
Dec 30, 2014
7214683*PED
Jun 30, 2015
U-138
7214684
Dec 30, 2014
7214684*PED
Jun 30, 2015
DP U-1017
7618649
Dec 19, 2020
7618649*PED
Jun 19, 2021
DP
7820199
Mar 28, 2022
7820199*PED
Sep 28, 2022
DESLORATADINE; PSEUDOEPHEDRINE SULFATE - CLARINEX-D
N021313 001 6100274
Jul 07, 2019
6100274*PED
Jan 07, 2020
6709676
Feb 18, 2021
7214683
Dec 30, 2014
7214683*PED
Jun 30, 2015
7214684
Dec 30, 2014
7214684*PED
Jun 30, 2015
7618649
Dec 19, 2020
7618649*PED
Jun 19, 2021

12 HOUR
DP
DP
DP

U-707

U-138
DP

DESMOPRESSIN ACETATE - DDAVP

N017922 001 5500413
5674850
5763407

Jun
Dec
Jun

29, 2013
23, 2013
29, 2013

DESMOPRESSIN ACETATE - DDAVP

N017922 002 5500413
5674850
5763407

Jun
Dec
Jun

29, 2013
23, 2013
29, 2013

DESMOPRESSIN ACETATE - DDAVP

N018938 001 5500413
5763407

Jun
Jun

29, 2013
29, 2013

DESMOPRESSIN ACETATE - DDAVP

N018938 002 5500413
5763407

Jun
Jun

29, 2013
29, 2013

DESMOPRESSIN ACETATE - DDAVP

N019955 001 5500413
5674850
5763407
7022340

Jun
Dec
Jun
Apr

29,
23,
29,
30,

2013
2013
2013
2023

DP

DESMOPRESSIN ACETATE - DDAVP

N019955 002 5500413
5674850
5763407
7022340

Jun
Dec
Jun
Apr

29,
23,
29,
30,

2013
2013
2013
2023

DP

U-1017

DESMOPRESSIN ACETATE - DDAVP (NEEDS NO REFRIGERATION)

N017922 003 5482931
Jun 29, 2013
5500413
Jun 29, 2013
5674850
Dec 23, 2013
5763407
Jun 29, 2013
DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE
N021795 001 7022340
Apr 30, 2023

DP

DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE

N021795 002 7022340
Apr 30, 2023

DP

DESONIDE - DESONATE
N021844 001 6387383

Aug

03, 2020

DS

DP

U-783

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 44 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

DESONIDE - VERDESO
N021978 001 6730288
7029659

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

Sep
Sep

08, 2019
08, 2019

DESVENLAFAXINE SUCCINATE - PRISTIQ

N021992 001 6673838
Feb

11, 2022

DS

DP

U-860

NCE

Mar

01, 2013

DESVENLAFAXINE SUCCINATE - PRISTIQ

N021992 002 6673838
Feb

11, 2022

DS

DP

U-860

NCE

Mar

01, 2013

DEXAMETHASONE - OZURDEX
N022315 001 6726918
6726918
6899717
7033605
7767223
8034366
8034366
8034370
8043628
8063031

20,
20,
01,
20,
28,
09,
09,
09,
20,
20,

DP
DP

U-1205
U-1204
U-1206

NDF
ODE

Jun
Sep

17, 2012
24, 2017

NP
PED

Jan
Jul

30, 2012
30, 2012

NP
PED

Jan
Jul

30, 2012
30, 2012

I-577

Oct

17, 2011

Oct
Oct
Nov
Oct
Nov
Jan
Jan
Jan
Oct
Oct

DP
DP

2020
2020
2023
2020
2021
2023
2023
2023
2020
2020

DP
DP
DP
DP
DP
DP
DP

DEXAMETHASONE; TOBRAMYCIN - TOBRADEX ST

Aug 03, 2028
N050818 001 7795316

U-1204
U-1205
U-1205

DP

U-1082

DS
DS
DS

DP
DP
DP

U-949
U-951
U-950

DS
DS
DS

DP
DP
DP

U-951
U-949
U-950

DEXLANSOPRAZOLE - DEXILANT
N022287 001 6462058
6462058
6462058
6462058*PED
6664276
6664276
6664276
6664276*PED
6939971
6939971
6939971
6939971*PED
7285668
7285668*PED
7790755
7790755*PED

Jun
Jun
Jun
Dec
Jun
Jun
Jun
Dec
Jun
Jun
Jun
Dec
Jun
Dec
Aug
Feb

15,
15,
15,
15,
15,
15,
15,
15,
15,
15,
15,
15,
15,
15,
02,
02,

2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2026
2027

DEXLANSOPRAZOLE - DEXILANT
N022287 002 6462058
6462058
6462058
6462058*PED
6664276
6664276
6664276
6664276*PED
6939971
6939971
6939971
6939971*PED
7285668
7285668*PED
7790755
7790755*PED

Jun
Jun
Jun
Dec
Jun
Jun
Jun
Dec
Jun
Jun
Jun
Dec
Jun
Dec
Aug
Feb

15,
15,
15,
15,
15,
15,
15,
15,
15,
15,
15,
15,
15,
15,
02,
02,

2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2026
2027

DS
DS
DS

DP
DP
DP

U-951
U-950
U-949

DS
DS
DS

DP
DP
DP

U-951
U-950
U-949

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX

Jul 15, 2013
N021038 001 4910214
Sep 06, 2011
5344840
Mar 31, 2019
6716867
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N021278 001 5908850
Dec 04, 2015
6355656
Dec 04, 2015
6528530
Dec 04, 2015

U-949
U-950
U-951
DS
DP

U-949
U-950
U-951
DS
DP

DS

DP

U-421
U-912
U-572

U-422
DS

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 45 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN

N021278 002 5908850
Dec 04, 2015
6355656
Dec 04, 2015
6528530
Dec 04, 2015
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N021278 003 5908850
Dec 04, 2015
6355656
Dec 04, 2015
6528530
Dec 04, 2015
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N021802 001 5837284
Dec 04, 2015
5908850
Dec 04, 2015
6228398
Nov 01, 2019
6355656
Dec 04, 2015
6528530
Dec 04, 2015
6635284
Dec 04, 2015
6730325
Nov 01, 2019
7431944
Dec 04, 2015
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N021802 002 5837284
Dec 04, 2015
5908850
Dec 04, 2015
6228398
Nov 01, 2019
6355656
Dec 04, 2015
6528530
Dec 04, 2015
6635284
Dec 04, 2015
6730325
Nov 01, 2019
7431944
Dec 04, 2015
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N021802 003 5837284
Dec 04, 2015
5908850
Dec 04, 2015
6228398
Nov 01, 2019
6355656
Dec 04, 2015
6528530
Dec 04, 2015
6635284
Dec 04, 2015
6730325
Nov 01, 2019
7431944
Dec 04, 2015
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N021802 004 5837284
Dec 04, 2015
5908850
Dec 04, 2015
6228398
Nov 01, 2019
6355656
Dec 04, 2015
6528530
Dec 04, 2015
6635284
Dec 04, 2015
6730325
Nov 01, 2019
7431944
Dec 04, 2015

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-422
DS

DP

U-422
DS

DP

DP
DP
DP
DP
DP
DP
DP

U-678
U-676

U-678
U-676

U-678
U-676

DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR

N021802 005 5837284
Dec 04, 2015
5908850
Dec 04, 2015
6228398
Nov 01, 2019
6355656
Dec 04, 2015
6528530
Dec 04, 2015
6635284
Dec 04, 2015
6730325
Nov 01, 2019
7431944
Dec 04, 2015

DP
DP
DP
DP
DP
DP
DP
DP

DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR

N021802 006 5837284
Dec 04, 2015
5908850
Dec 04, 2015
6228398
Nov 01, 2019
6355656
Dec 04, 2015
6528530
Dec 04, 2015
6635284
Dec 04, 2015
6730325
Nov 01, 2019
7431944
Dec 04, 2015

DP
DP
DP
DP
DP
DP
DP
DP

Oct
23, 2012
Oct
17, 2011

D-121
M-80

Oct
23, 2012
Oct
17, 2011

D-121
M-80

Oct
23, 2012
Oct
17, 2011

D-121
M-80

Oct
23, 2012
Oct
17, 2011

D-121
M-80

Oct
Oct

U-677
U-676

DP
DP
DP
DP
DP
DP
DP

D-121
M-80

U-677
U-676

DP
DP
DP
DP
DP
DP
DP

Oct
23, 2012
Oct
17, 2011

U-677
U-676

DP
DP
DP
DP
DP
DP
DP

D-121
M-80

U-678
U-676

U-677
U-676

U-678
U-676

U-677
U-676

U-677
U-678
U-676

U-677
U-676

23, 2012

17, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 46 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR

N021802 007 5837284
Dec 04, 2015
5908850
Dec 04, 2015
6228398
Nov 01, 2019
6355656
Dec 04, 2015
6528530
Dec 04, 2015
6635284
Dec 04, 2015
6730325
Nov 01, 2019
7431944
Dec 04, 2015

DP
DP
DP
DP
DP
DP
DP
DP

DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR

N021802 008 5837284
Dec 04, 2015
5908850
Dec 04, 2015
6228398
Nov 01, 2019
6355656
Dec 04, 2015
6528530
Dec 04, 2015
6635284
Dec 04, 2015
6730325
Nov 01, 2019
7431944
Dec 04, 2015

DP
DP
DP
DP
DP
DP
DP
DP

DEXRAZOXANE HYDROCHLORIDE - TOTECT

N022025 001 6727253
Mar

U-678
U-676

U-678
U-676

GUAIFENESIN - MUCINEX DM
Apr 28, 2020
DP
DP U-685
Apr 28, 2020
DP
Apr 28, 2020

DEXTROMETHORPHAN HYDROBROMIDE;
N021620 002 6372252
6955821
7838032

GUAIFENESIN - MUCINEX DM
Apr 28, 2020
DP
DP U-685
Apr 28, 2020
DP
Apr 28, 2020

DEXTROMETHORPHAN HYDROBROMIDE;
N021879 001 5206248
7659282
RE38115

QUINIDINE SULFATE - NUEDEXTA

Mar 27, 2012
U-1093
U-1093
Aug 13, 2026
Jan 26, 2016
DP

DP

DIAZEPAM - DIASTAT
N020648 001 5462740

Sep

17, 2013

DP

DIAZEPAM - DIASTAT
N020648 002 5462740

Sep

17, 2013

DP

DIAZEPAM - DIASTAT
N020648 003 5462740

Sep

17, 2013

DP

DIAZEPAM - DIASTAT
N020648 004 5462740

Sep

17, 2013

DP

DIAZEPAM - DIASTAT
N020648 005 5462740

Sep

17, 2013

DP

DIAZEPAM - DIASTAT ACUDIAL

N020648 006 5462740

Sep

17, 2013

DP

DIAZEPAM - DIASTAT ACUDIAL

N020648 007 5462740

Sep

17, 2013

DP

DICLOFENAC EPOLAMINE - FLECTOR

N021234 001 5607690
Apr

13, 2014

DP

DICLOFENAC POTASSIUM - CAMBIA

N022165 001 6974595
7482377
7759394

15, 2017
15, 2017
16, 2026

May
May
Jun

DS
DS

DP
DP

EXCLUSIVITY
EXPIRATION
DATE

D-121
M-80

Oct
Oct

23, 2012
17, 2011

D-121
M-80

Oct
Oct

23, 2012
17, 2011

ODE

Sep

06, 2014

NC

Oct

29, 2013

NDF

Jun

17, 2012

U-677
U-676

DEXTROMETHORPHAN HYDROBROMIDE;
N021620 001 6372252
6955821
7838032

DEXTROMETHORPHAN POLISTIREX - DELSYM

N018658 001 5980882
Apr 16, 2017

EXCLUSIVITY
CODE(S)

U-677
U-676

U-829

13, 2020

PATENT
DELIST
REQUESTED

U-436
U-436
U-436

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 47 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

DICLOFENAC POTASSIUM - ZIPSOR

N022202 001 6365180
7662858
7884095
7939518

PATENT
EXPIRATION
DATE

Jul
Feb
Feb
Feb

15,
24,
24,
24,

2019
2029
2029
2029

PATENT
CODES
DP

DICLOFENAC SODIUM - DICLOFENAC SODIUM

N020809 001 5603929
Nov 16, 2014
5653972
Nov 16, 2014

PATENT
DELIST
REQUESTED

U-980
U-1035
U-1111
U-980

Jun
Aug
Jun
Aug
Jun
Aug

17,
11,
17,
11,
17,
11,

2014
2015
2014
2015
2014
2015

EXCLUSIVITY
EXPIRATION
DATE

NDF

Jun

16, 2012

NDF

Nov

04, 2012

NP

May

06, 2013

NCE

Jun

23, 2013

U-239
U-239

DICLOFENAC SODIUM - PENNSAID

N020947 001
DICLOFENAC SODIUM - SOLARAZE
N021005 001 5639738
5792753
5852002
5914322
5929048
5985850

EXCLUSIVITY
CODE(S)

U-402
U-402
U-402
DP

DICLOFENAC SODIUM; MISOPROSTOL - ARTHROTEC

N020607 001 5601843
Feb 11, 2014
DICLOFENAC SODIUM; MISOPROSTOL - ARTHROTEC
N020607 002 5601843
Feb 11, 2014
DIDANOSINE - VIDEX
N020154 002 5880106
5880106*PED

Jul
Jan

22, 2011
22, 2012

DIDANOSINE - VIDEX
N020154 003 5880106
5880106*PED

Jul
Jan

22, 2011
22, 2012

DIDANOSINE - VIDEX
N020154 004 5880106
5880106*PED

Jul
Jan

22, 2011
22, 2012

DIDANOSINE - VIDEX
N020154 005 5880106
5880106*PED

Jul
Jan

22, 2011
22, 2012

DIDANOSINE - VIDEX
N020154 006 5880106
5880106*PED

Jul
Jan

22, 2011
22, 2012

DIENOGEST; ESTRADIOL VALERATE - NATAZIA

Oct 25,
N022252 001 6133251
Oct 25,
6133251
Oct 25,
6133251
Oct 25,
6884793
May 13,
8071577
DIFLUPREDNATE - DUREZOL
N022212 001 6114319

May

2016
2016
2016
2016
2026

DP
DP
DP
DP
DP

18, 2019

DP

U-828
U-112
U-1

Y
Y
Y
Y

U-1

DILTIAZEM HYDROCHLORIDE - CARDIZEM CD

N020062 001 5364620
Nov 14, 2011
5439689
Aug 08, 2012

U-3
U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM CD

N020062 002 5364620
Nov 14, 2011
5439689
Aug 08, 2012

U-3
U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM CD

N020062 003 5364620
Nov 14, 2011
5439689
Aug 08, 2012

U-3
U-107

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 48 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

DILTIAZEM HYDROCHLORIDE - CARDIZEM CD

N020062 004 5364620
Nov 14, 2011
5439689
Aug 08, 2012

U-3
U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM CD

N020062 005 5439689
Aug 08, 2012

DP

U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM LA

N021392 001 5529791
Jun 25, 2013
6923984
Feb 25, 2021
7108866
Dec 17, 2019

DP
DP

U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM LA

N021392 002 5529791
Jun 25, 2013
6923984
Feb 25, 2021
7108866
Dec 17, 2019

DP
DP

U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM LA

N021392 003 5529791
Jun 25, 2013
6923984
Feb 25, 2021
7108866
Dec 17, 2019

DP
DP

U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM LA

N021392 004 5529791
Jun 25, 2013
6923984
Feb 25, 2021
7108866
Dec 17, 2019

DP
DP

U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM LA

N021392 005 5529791
Jun 25, 2013
6923984
Feb 25, 2021
7108866
Dec 17, 2019

DP
DP

U-107

DILTIAZEM HYDROCHLORIDE - CARDIZEM LA

N021392 006 5529791
Jun 25, 2013
6923984
Feb 25, 2021
7108866
Dec 17, 2019

DP
DP

U-107

DILTIAZEM HYDROCHLORIDE - DILACOR XR

N020092 001 5422123
Jun 06, 2012
DILTIAZEM HYDROCHLORIDE - DILACOR XR
N020092 002 5422123
Jun 06, 2012
DILTIAZEM HYDROCHLORIDE - DILACOR XR
N020092 003 5422123
Jun 06, 2012
DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE
N020939 001 5529791
Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE
N020939 002 5529791
Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE
N020939 003 5529791
Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE
N020939 004 5529791
Jun 25, 2013
DILTIAZEM HYDROCHLORIDE - TIAZAC
N020401 001 5529791
Jun

25, 2013

DILTIAZEM HYDROCHLORIDE - TIAZAC

N020401 002 5529791
Jun

25, 2013

DILTIAZEM HYDROCHLORIDE - TIAZAC

N020401 003 5529791
Jun

25, 2013

DILTIAZEM HYDROCHLORIDE - TIAZAC

N020401 004 5529791
Jun

25, 2013

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 49 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DILTIAZEM HYDROCHLORIDE - TIAZAC

N020401 005 5529791
Jun

25, 2013

DILTIAZEM HYDROCHLORIDE - TIAZAC

N020401 006 5529791
Jun

25, 2013

PATENT
CODES

DIMYRISTOYL LECITHIN; PERFLEXANE - IMAGENT

Feb 25, 2014
N021191 001 5605673
May 16, 2014
5626833
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
DINOPROSTONE - CERVIDIL
N020411 001 5269321

Jul

14, 2012

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-458
U-458
U-458

DP

U-110

DIVALPROEX SODIUM - DEPAKOTE

N019680 001
DIVALPROEX SODIUM - DEPAKOTE ER
N021168 001 6419953
Dec
6419953*PED
Jun
6511678
Dec
6511678*PED
Jun
6528090
Dec
6528090*PED
Jun
6528091
Dec
6528091*PED
Jun
6713086
Dec
6713086*PED
Jun
6720004
Dec
6720004*PED
Jun

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

2018
2019
2018
2019
2018
2019
2018
2019
2018
2019
2018
2019

DIVALPROEX SODIUM - DEPAKOTE ER

N021168 002 6511678
Dec
6511678*PED
Jun
6528090
Dec
6528090*PED
Jun
6713086
Dec
6713086*PED
Jun
6720004
Dec
6720004*PED
Jun

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

2018
2019
2018
2019
2018
2019
2018
2019

DOCETAXEL - TAXOTERE
N020449 001 5438072
5438072*PED
5698582
5698582*PED
5714512
5714512*PED
5750561
5750561*PED

Nov
May
Jul
Jan
Jul
Jan
Jul
Jan

22,
22,
03,
03,
03,
03,
03,
03,

2013
2014
2012
2013
2012
2013
2012
2013

DP

DOCETAXEL - TAXOTERE
N020449 003 5698582
5698582*PED
5714512
5714512*PED
5750561
5750561*PED

Jul
Jan
Jul
Jan
Jul
Jan

03,
03,
03,
03,
03,
03,

2012
2013
2012
2013
2012
2013

DP

PED

Sep

24, 2011

PED

Sep

24, 2011

PED

Sep

24, 2011

M-61
PED

May
Nov

13, 2013
13, 2013

M-61
PED

May
Nov

13, 2013
13, 2013

DP
U-106
DP

U-579

DP

DP
DP

U-579

DP

DP
DP
DP

DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 50 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DOCETAXEL - TAXOTERE
N020449 004 5698582
5698582*PED
5714512
5714512*PED
5750561
5750561*PED

Jul
Jan
Jul
Jan
Jul
Jan

03,
03,
03,
03,
03,
03,

DOCOSANOL - ABREVA
N020941 001 4874794
5534554

Apr
Dec

28, 2014
13, 2013

DOFETILIDE - TIKOSYN
N020931 001 4959366
6124363

Sep
Oct

25, 2012
09, 2018

DOFETILIDE - TIKOSYN
N020931 002 4959366
6124363

Sep
Oct

DOFETILIDE - TIKOSYN
N020931 003 4959366
6124363

PATENT
CODES

PATENT
DELIST
REQUESTED

DP

2012
2013
2012
2013
2012
2013

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

M-61
PED

May
Nov

13, 2013
13, 2013

NP

Jul

23, 2013

DP
DP

DP

U-815
U-815

DS

DP

U-652

25, 2012
09, 2018

DS

DP

U-652

Sep
Oct

25, 2012
09, 2018

DS

DP

U-652

DOLASETRON MESYLATE - ANZEMET

N020623 001 4906755

Jul

02, 2011

DOLASETRON MESYLATE - ANZEMET

N020623 002 4906755

Jul

02, 2011

DOLASETRON MESYLATE - ANZEMET

N020624 001 4906755

Jul

02, 2011

DOLASETRON MESYLATE - ANZEMET

N020624 002 4906755

Jul

02, 2011

DOLASETRON MESYLATE - ANZEMET

N020624 003 4906755

Jul

02, 2011

DONEPEZIL HYDROCHLORIDE - ARICEPT

N020690 001 5985864
Dec
6140321
Dec
6245911
Dec
6372760
Mar

30,
30,
01,
31,

2016
2016
2018
2019

DONEPEZIL HYDROCHLORIDE - ARICEPT

N020690 002 5985864
Dec
6140321
Dec
6245911
Dec
6372760
Mar

30,
30,
01,
31,

2016
2016
2018
2019

DONEPEZIL HYDROCHLORIDE - ARICEPT

N022568 001
DONEPEZIL HYDROCHLORIDE - ARICEPT ODT
N021720 001 7727548
Jun 23, 2022
7727552
Mar 26, 2018

DP
DP

U-1062

DONEPEZIL HYDROCHLORIDE - ARICEPT ODT

N021720 002 7727548
Jun 23, 2022
7727552
Mar 26, 2018

DP
DP

U-1062

DORIPENEM - DORIBAX
N022106 001 5317016

Jun

05, 2015

DS

DP

U-282

NCE

Oct

12, 2012

DORIPENEM - DORIBAX
N022106 002 5317016

Jun

05, 2015

DS

DP

U-282

NCE

Oct

12, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 51 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DOXEPIN HYDROCHLORIDE - SILENOR

Mar
N022036 001 5502047
Jan
5585115
Jan
5725884
Jan
5866166
Jan
5948438
Jan
6103219
Feb
6211229
Jan
6217909
Aug
7915307

26,
09,
09,
09,
09,
09,
17,
09,
24,

2013
2015
2015
2015
2015
2015
2020
2015
2027

DOXEPIN HYDROCHLORIDE - SILENOR

Mar
N022036 002 5502047
Jan
5585115
Jan
5725884
Jan
5866166
Jan
5948438
Jan
6103219
Feb
6211229
Jan
6217909
Aug
7915307

26,
09,
09,
09,
09,
09,
17,
09,
24,

2013
2015
2015
2015
2015
2015
2020
2015
2027

DOXERCALCIFEROL - HECTOROL
N020862 001 5602116
5602116
6903083

Feb
Feb
Jul

11, 2014
11, 2014
18, 2021

DOXERCALCIFEROL - HECTOROL
N020862 002 5602116
5602116
6903083

Feb
Feb
Jul

11, 2014
11, 2014
18, 2021

DOXERCALCIFEROL - HECTOROL
N020862 003 5602116

Feb

11, 2014

DOXERCALCIFEROL - HECTOROL
N021027 001 5602116
6903083
7148211

Feb
Jul
Sep

11, 2014
18, 2021
14, 2023

DOXERCALCIFEROL - HECTOROL
N021027 002 5602116
7148211

Feb
Sep

11, 2014
14, 2023

PATENT
CODES

PATENT
DELIST
REQUESTED

U-620

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NP

Mar

17, 2013

NP

Mar

17, 2013

DOXORUBICIN HYDROCHLORIDE - DOXIL

N050718 001

ODE

May

17, 2014

DOXORUBICIN HYDROCHLORIDE - DOXIL

N050718 002

ODE

May

17, 2014

NCE

Jul

01, 2014

DP
DP
DP
DP
DP
U-620
DP
U-620

U-620
DP
DP
DP
DP
DP
U-620
DP
U-620

U-278
U-987
DS

DP

U-278
U-987
DS

DP

U-987

U-321
DS

DP
DP

U-321
DP

DOXYCYCLINE - ORACEA
N050805 001 5789395
5919775
7211267
7232572
7749532

Aug
Aug
Apr
Apr
Dec

30,
30,
05,
05,
19,

2016
2016
2022
2022
2027

DP

U-925
U-925
U-925
U-925
U-1063

DOXYCYCLINE HYCLATE - DORYX

N050795 001 6958161

Dec

15, 2022

DP

U-918

DOXYCYCLINE HYCLATE - DORYX

N050795 002 6958161

Dec

15, 2022

DP

U-918

DOXYCYCLINE HYCLATE - DORYX

N050795 003 6958161

Dec

15, 2022

DP

U-918

DRONEDARONE HYDROCHLORIDE - MULTAQ

N022425 001 5223510
Jul
7323493
Jun

26, 2012
19, 2018

DP
DP

U-992

DS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 52 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DROSPIRENONE; ESTRADIOL - ANGELIQ

N021355 002 6933395
Aug

11, 2017

DROSPIRENONE; ETHINYL ESTRADIOL - YASMIN

N021098 001 5569652
Oct 29, 2013
6787531
Aug 31, 2020
Aug 11, 2017
6933395
DROSPIRENONE; ETHINYL ESTRADIOL - YAZ
N021676 001 5569652
Oct 29,
5798338
Jul 10,
6787531
Aug 31,
Aug 11,
6933395
Dec 20,
6958326
Dec 22,
6987101
Dec 20,
7163931
Jun 30,
RE37564
Jun 30,
RE37838
Jun 30,
RE38253

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS

U-1
DP
DS

U-1

2013
2015
2020
2017
2021
2017
2021
2014
2014
2014

DP
DP
DP
DP
U-758
U-1
DP
DP
DP

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - BEYAZ

N022532 001 5798338
Jul 10, 2015
DP
DS
6441168
Apr 17, 2020
DP
6958326
Dec 30, 2021
U-1
7163931
Mar 03, 2022
DP
RE37564
Jun 30, 2014
DP
RE37838
Jun 30, 2014
DP
RE38253
Jun 30, 2014
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - SAFYRAL
N022574 001 5798338
Jul 10, 2015
DP
DS
6441168
Apr 17, 2020
DP
6958326
Dec 20, 2021
U-1
7163931
Mar 03, 2022
DULOXETINE HYDROCHLORIDE - CYMBALTA
N021427 001 5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5508276
Jul 18, 2014
6596756
Sep 10, 2019

DS
DS
DS
DS
DS
DS
DS
DS
DS

DULOXETINE HYDROCHLORIDE - CYMBALTA

N021427 002 5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5508276
Jul 18, 2014
6596756
Sep 10, 2019

DS
DS
DS
DS
DS
DS
DS
DS
DS

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

U-605
U-1094
U-799
U-398
U-839
U-797
U-795
U-882
U-796

NC
NP

Sep
Sep

24, 2013
24, 2013

NP

Dec

16, 2013

I-632
I-617

Nov
Nov

04, 2013
19, 2012

I-632
I-617

Nov
Nov

04, 2013
19, 2012

U-882

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

U-1094
U-605
U-882
U-839
U-799
U-795
U-796
U-797
U-398
U-882

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 53 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

DULOXETINE HYDROCHLORIDE - CYMBALTA

Jun 11, 2013
N021427 004 5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jun 11, 2013
5023269
Jul 18, 2014
5508276
Sep 10, 2019
6596756

DS
DS
DS
DS
DS
DS
DS
DS
DS

DUTASTERIDE - AVODART
N021319 001 5565467
5846976
5998427

DS

DP

DS

DP

DS

DP

DS

DP

Nov
Sep
Sep

20, 2015
17, 2013
17, 2013

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

U-799
U-605
U-1094
U-398
U-882
U-795
U-796
U-797
U-839
U-882

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE N022460 001 5565467

Nov 20,
5846976
Sep 17,
Sep 17,
5998427

JALYN
2015
2013
2013

EFAVIRENZ - SUSTIVA
N020972 001 5519021
5663169
5811423
6238695
6555133
6639071
6939964

May
Sep
Aug
Apr
Apr
Feb
Jan

21,
02,
07,
06,
06,
14,
20,

2013
2014
2012
2019
2019
2018
2018

DS

DP

DS

DP
DP

EFAVIRENZ - SUSTIVA
N020972 002 5519021
5663169
5811423
6238695
6555133
6639071
6939964

May
Sep
Aug
Apr
Apr
Feb
Jan

21,
02,
07,
06,
06,
14,
20,

2013
2014
2012
2019
2019
2018
2018

DS

DP

DS

DP
DP

EFAVIRENZ - SUSTIVA
N020972 003 5519021
5663169
5811423
6238695
6555133
6639071
6939964

May
Sep
Aug
Apr
Apr
Feb
Jan

21,
02,
07,
06,
06,
14,
20,

2013
2014
2012
2019
2019
2018
2018

DS

DP

DS

DP
DP

EFAVIRENZ - SUSTIVA
N021360 001 5519021
5663169
5811423
6639071
6939964

May
Sep
Aug
Feb
Jan

21,
02,
07,
14,
20,

2013
2014
2012
2018
2018

EFAVIRENZ - SUSTIVA
N021360 002 5519021
5663169
5811423
6639071
6939964

May
Sep
Aug
Feb
Jan

21,
02,
07,
14,
20,

2013
2014
2012
2018
2018

U-476
U-477

U-1065
U-1066

U-257
U-256
U-248

DS
DS

U-257
U-256
U-248

DS
DS

U-257
U-256
U-248

DS
DS

U-256
DS
DS

DS

DP
U-248
U-256

DS
DS

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)
I-632
I-617

EXCLUSIVITY
EXPIRATION
DATE

Nov
Nov

04, 2013
19, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 54 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

EFAVIRENZ; EMTRICITABINE; TENOFOVIR

N021937 001 5519021
May
Sep
5663169
Aug
5811423
Sep
5814639
Mar
5814639*PED
Jul
5914331
Jan
5914331*PED
Jul
5922695
Jan
5922695*PED
Jul
5935946
Jan
5935946*PED
Jul
5977089
Jan
5977089*PED
Jul
6043230
Jan
6043230*PED
Feb
6639071
Nov
6642245
May
6642245*PED
Mar
6703396
Sep
6703396*PED
Jan
6939964

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DISOPROXIL FUMARATE - ATRIPLA

21, 2013
DS DP
U-750
02, 2014
U-750
07, 2012
DS DP
29, 2015
29, 2016
DS
02, 2017
02, 2018
DS
U-750
25, 2017
25, 2018
DS DP U-750
25, 2017
25, 2018
DS DP U-750
25, 2017
25, 2018
U-750
25, 2017
25, 2018
DS
14, 2018
U-750
04, 2020
04, 2021
DS DP
09, 2021
09, 2021
DS
20, 2018

EFLORNITHINE HYDROCHLORIDE - VANIQA

N021145 001 5648394
Jul 15, 2014

U-334

ELETRIPTAN HYDROBROMIDE - RELPAX

N021016 001 5545644
Dec
6110940
Aug

26, 2016
29, 2017

DS

DP

U-876

ELETRIPTAN HYDROBROMIDE - RELPAX

N021016 002 5545644
Dec
6110940
Aug

26, 2016
29, 2017

DS

DP

U-876

ELTROMBOPAG OLAMINE - PROMACTA

N022291 001 6280959
7160870
7332481
7452874
7473686
7547719
7790704
7795293
8052993

Oct
Dec
May
May
May
Jul
May
May
Aug

30,
08,
24,
24,
24,
13,
24,
21,
01,

2018
2021
2021
2021
2021
2025
2021
2023
2027

DS
DS

DP
DP

U-930
U-930
U-930

DS
DS
DS

DP
DP
DP

ELTROMBOPAG OLAMINE - PROMACTA

N022291 002 6280959
7160870
7332481
7452874
7473686
7547719
7790704
7795293
8052994

Oct
Dec
May
May
May
Jul
May
May
Aug

30,
08,
24,
24,
24,
13,
24,
21,
01,

2018
2021
2021
2021
2021
2025
2021
2023
2027

DS
DS

DP
DP

DS
DS
DS

DP
DP
DP

ELTROMBOPAG OLAMINE - PROMACTA

N022291 003 6280959
7160870
7332481
7452874
7473686
7547719
7790704
7795293
8062665

Oct
Dec
May
May
May
Jul
May
May
Aug

30,
08,
24,
24,
24,
13,
24,
21,
01,

2018
2021
2021
2021
2021
2025
2021
2023
2027

DS
DS

DP
DP

DS
DS
DS

DP
DP
DP

DP

DP

DP

NCE
ODE

Nov
Nov

20, 2013
20, 2015

NCE
ODE

Nov
Nov

20, 2013
20, 2015

NCE
ODE

Nov
Nov

20, 2013
20, 2015

U-930
U-930
U-930
U-930
U-930

U-930
U-930
U-930
U-930
U-930
U-930
U-930
U-930

U-930
U-930
U-930
U-930
U-930
U-930
U-930
U-930

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 55 of 207

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

N022291 004 6280959
7160870
7332481
7452874
7473686
7547719
7790704
7795293
8071129

PATENT
EXPIRATION
DATE

Oct
Dec
May
May
May
Jul
May
May
Aug

30,
08,
24,
24,
24,
13,
24,
21,
01,

2018
2021
2021
2021
2021
2025
2021
2023
2027

PATENT
CODES
DS
DS

DP
DP

DS
DS
DS

DP
DP
DP

DP

EMEDASTINE DIFUMARATE - EMADINE

N020706 001 5441958
Dec

08, 2013

EMTRICITABINE - EMTRIVA
N021500 001 5814639
5814639*PED
5914331
5914331*PED
6642245
6642245
6642245*PED
6703396
6703396*PED

Sep
Mar
Jul
Jan
Nov
Nov
May
Mar
Sep

29,
29,
02,
02,
04,
04,
04,
09,
09,

2015
2016
2017
2018
2020
2020
2021
2021
2021

DS

DS

DP

EMTRICITABINE - EMTRIVA
N021896 001 5814639
5814639*PED
5914331
5914331*PED
6642245
6642245*PED
6703396
6703396*PED

Sep
Mar
Jul
Jan
Nov
May
Mar
Sep

29,
29,
02,
02,
04,
04,
09,
09,

2015
2016
2017
2018
2020
2021
2021
2021

DS

DP

PATENT
DELIST
REQUESTED

U-930
U-930
U-930
U-930
U-930
U-930
U-930
U-930

U-404

DP

DS
U-257
U-541

DS
U-257
DS

DP

EMTRICITABINE; RILPIVIRINE; TENOFOVIR DISOPROXIL FUMARATE - COMPLERA

DS DP
N202123 001 5814639
Sep 29, 2015
Mar 29, 2016
5814639*PED
Jul 02, 2017
5914331
DS
Jan 02, 2018
5914331*PED
Jul 25, 2017
DS
U-257
5922695
Jan 25, 2018
5922695*PED
Jul 25, 2017
DS DP U-257
5935946
Jan 25, 2018
5935946*PED
DS DP
Jul 25, 2017
5977089
U-257
Jan 25, 2018
5977089*PED
U-257
Jul 25, 2017
6043230
Jan 25, 2018
6043230*PED
U-257
Nov 04, 2020
6642245
May 04, 2021
6642245*PED
Mar 09, 2021
DS DP
6703396
Sep 09, 2021
6703396*PED
Feb 26, 2021
DS DP
6838464
Dec 20, 2019
DS DP
7067522
DS DP U-257
Apr 14, 2023
7125879

EXCLUSIVITY
CODE(S)
NCE
ODE

EXCLUSIVITY
EXPIRATION
DATE

Nov
Nov

20, 2013
20, 2015

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 56 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

EMTRICITABINE; TENOFOVIR DISOPROXIL

N021752 001 5814639
Sep
5814639*PED
Mar
5914331
Jul
5914331*PED
Jan
5922695
Jul
5922695
Jul
5922695
Jul
5922695*PED
Jan
5935946
Jul
5935946
Jul
5935946
Jul
5935946*PED
Jan
5977089
Jul
5977089
Jul
5977089
Jul
5977089*PED
Jan
6043230
Jul
6043230
Jul
6043230
Jul
6043230*PED
Jan
6642245
Nov
6642245
Nov
6642245
Nov
6642245*PED
May
6703396
Mar
6703396*PED
Sep

FUMARATE - TRUVADA
29, 2015
DS DP
29, 2016
DS DP U-248
02, 2017
DS
02, 2018
25, 2017
DS
U-248
DS
U-541
25, 2017
DS
U-1170
25, 2017
25, 2018
DS DP U-541
25, 2017
25, 2017
DS DP U-248
DS DP U-1170
25, 2017
25, 2018
DS DP U-1170
25, 2017
DS DP U-541
25, 2017
25, 2017
DS DP U-248
25, 2018
DP U-248
25, 2017
DP U-1170
25, 2017
25, 2017
DP U-541
25, 2018
U-1170
04, 2020
U-248
04, 2020
U-541
04, 2020
04, 2021
DS DP
09, 2021
09, 2021

ENFUVIRTIDE - FUZEON
N021481 001 5464933
6133418
6475491

Jun
Nov
Jun

07, 2013
17, 2014
07, 2015

DS

ENOXAPARIN SODIUM - LOVENOX

N020164 009 5389618
RE38743

Feb
Feb

14, 2012
14, 2012

DS
DS

DP
DP

U-545
U-545

ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)

DS
N020164 001 5389618
Feb 14, 2012
DS
RE38743
Feb 14, 2012

DP
DP

U-545
U-545

ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)

DS
N020164 002 5389618
Feb 14, 2012
RE38743
Feb 14, 2012
DS

DP
DP

U-545

U-545

ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)

DS
N020164 003 5389618
Feb 14, 2012
RE38743
Feb 14, 2012
DS

DP
DP

U-545

U-545

ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)

N020164 004 5389618
Feb 14, 2012
DS
DS
RE38743
Feb 14, 2012

DP
DP

U-545
U-545

ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)

DS
N020164 005 5389618
Feb 14, 2012
DS
RE38743
Feb 14, 2012

DP
DP

U-545
U-545

ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)

DS
N020164 006 5389618
Feb 14, 2012
DS
RE38743
Feb 14, 2012

DP
DP

U-545
U-545

ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)

DS
N020164 007 5389618
Feb 14, 2012
DS
RE38743
Feb 14, 2012

DP
DP

U-545
U-545

ENOXAPARIN SODIUM - LOVENOX (PRESERVATIVE FREE)

N020164 008 5389618
Feb 14, 2012
DS
DS
RE38743
Feb 14, 2012

DP
DP

U-545
U-545

DP
U-248

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 57 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ENTACAPONE - COMTAN
N020796 001 5446194
6599530

Oct
Sep

19, 2013
14, 2018

DS

ENTECAVIR - BARACLUDE
N021797 001 5206244

Feb

21, 2015

DS

D-127

Oct

15, 2013

ENTECAVIR - BARACLUDE
N021797 002 5206244

Feb

21, 2015

DS

D-127

Oct

15, 2013

ENTECAVIR - BARACLUDE
N021798 001 5206244

Feb

21, 2015

DS

D-127

Oct

15, 2013

EPINASTINE HYDROCHLORIDE - ELESTAT

N021565 001 7429602
Nov

29, 2020

PC

Oct

29, 2011

DP

U-219

U-765

EPINASTINE HYDROCHLORIDE - EPINASTINE HYDROCHLORIDE

A090870 001
EPINEPHRINE - ADRENACLICK
N020800 003 5665071

May

27, 2013

DP

EPINEPHRINE - ADRENACLICK
N020800 004 5665071

May

27, 2013

DP

EPINEPHRINE - EPIPEN
N019430 001 7449012
7794432
8048035

Sep
Sep
Sep

11, 2025
11, 2025
11, 2025

DP
DP
DP

EPINEPHRINE - EPIPEN JR.

N019430 002 7449012
7794432
8048035

Sep
Sep
Sep

11, 2025
11, 2025
11, 2025

DP
DP
DP

EPINEPHRINE - TWINJECT 0.15

N020800 002 7297136
7621891

Jan
Feb

18, 2025
04, 2025

DP
DP

EPINEPHRINE - TWINJECT 0.3

N020800 001 7297136
7621891

Jan
Feb

18, 2025
04, 2025

DP
DP

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE - LIDOSITE

N021504 001 5246418
Sep 30, 2013
Sep 30, 2013
5873850
Sep 30, 2013
6377847
Sep 30, 2013
6385488
Jun 30, 2020
6629968
Jun 29, 2021
6635045
Sep 30, 2013
6862473

TOPICAL SYSTEM KIT

DS DP
DS DP
DS DP
DS DP
DS DP
DS DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 58 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

EPLERENONE - INSPRA
N021437 001 6410054
6410054
6410054*PED
6410524
6410524*PED
6495165
6495165
6495165*PED
6534093
6534093
6534093*PED
6558707
6558707*PED
6747020
6747020*PED
6863902
6863902*PED
7157101
7157101*PED

Dec
Dec
Jun
Nov
May
Dec
Dec
Jun
Dec
Dec
Jun
Dec
Jun
Nov
May
Apr
Oct
Dec
Jun

08,
08,
08,
05,
05,
08,
08,
08,
08,
08,
08,
08,
08,
05,
05,
10,
10,
08,
08,

2019
2019
2020
2019
2020
2019
2019
2020
2019
2019
2020
2019
2020
2019
2020
2020
2020
2019
2020

EPLERENONE - INSPRA
N021437 002 6410054
6410054
6410054*PED
6410524
6410524*PED
6495165
6495165
6495165*PED
6534093
6534093
6534093*PED
6558707
6558707*PED
6747020
6747020*PED
6863902
6863902*PED
7157101
7157101*PED

Dec
Dec
Jun
Nov
May
Dec
Dec
Jun
Dec
Dec
Jun
Dec
Jun
Nov
May
Apr
Oct
Dec
Jun

08,
08,
08,
05,
05,
08,
08,
08,
08,
08,
08,
08,
08,
05,
05,
10,
10,
08,
08,

2019
2019
2020
2019
2020
2019
2019
2020
2019
2019
2020
2019
2020
2019
2020
2020
2020
2019
2020

EPLERENONE - INSPRA
N021437 003 6410054
6410054
6410054*PED
6410524
6410524*PED
6495165
6495165
6495165*PED
6534093
6534093
6534093*PED
6558707
6558707*PED
6747020
6747020*PED
6863902
6863902*PED
7157101
7157101*PED

Dec
Dec
Jun
Nov
May
Dec
Dec
Jun
Dec
Dec
Jun
Dec
Jun
Nov
May
Apr
Oct
Dec
Jun

08,
08,
08,
05,
05,
08,
08,
08,
08,
08,
08,
08,
08,
05,
05,
10,
10,
08,
08,

2019
2019
2020
2019
2020
2019
2019
2020
2019
2019
2020
2019
2020
2019
2020
2020
2020
2019
2020

EPROSARTAN MESYLATE - TEVETEN

N020738 004 5656650

Aug

12, 2014

U-3

EPROSARTAN MESYLATE - TEVETEN

N020738 005 5656650

Aug

12, 2014

U-3

U-3
U-537

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

PED

Jul

31, 2011

PED

Jul

31, 2011

U-467
U-3
U-537
U-537
U-3
DP

U-537
U-587

DP

U-664

DP

U-664

U-3
U-537
U-467
U-3
U-537
U-3
U-537
DP

U-537
U-587

DP

U-664

DP

U-664

U-3
U-537
U-467
U-3
U-537
U-3
U-537
DP

U-537
U-587

DP

U-664

DP

U-664

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 59 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

EPROSARTAN MESYLATE - TEVETEN

N020738 006 5656650

PATENT
EXPIRATION
DATE

Aug

PATENT
CODES

12, 2014

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-3

EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE - TEVETEN HCT

U-3
N021268 001 5656650
Aug 12, 2014
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE - TEVETEN HCT
U-3
N021268 002 5656650
Aug 12, 2014
EPTIFIBATIDE - INTEGRILIN
N020718 001 5686570
5747447
5756451
5807825
5968902

Nov
May
Nov
Sep
Jun

11,
05,
11,
15,
02,

2014
2015
2014
2015
2015

U-244
U-453

EPTIFIBATIDE - INTEGRILIN
N020718 002 5686570
5747447
5756451
5807825
5968902

Nov
May
Nov
Sep
Jun

11,
05,
11,
15,
02,

2014
2015
2014
2015
2015

U-244
U-453

ERIBULIN MESYLATE - HALAVEN

N201532 001 6214865
6469182
7470720

Jun
Jun
Jun

16, 2019
16, 2019
16, 2019

DS

ERLOTINIB HYDROCHLORIDE - TARCEVA

N021743 001 5747498
Nov
6900221
Nov
6900221
Nov
6900221
Nov
7087613
Nov
7087613
Nov
RE41065
Nov

08,
09,
09,
09,
09,
09,
08,

2018
2020
2020
2020
2020
2020
2018

DS
DS
DS
DS

DP
DP
DP
DP

DS

DP

ERLOTINIB HYDROCHLORIDE - TARCEVA

N021743 002 5747498
Nov
6900221
Nov
6900221
Nov
6900221
Nov
7087613
Nov
7087613
Nov
RE41065
Nov

08,
09,
09,
09,
09,
09,
08,

2018
2020
2020
2020
2020
2020
2018

DS
DS
DS
DS

DP
DP
DP
DP

DS

DP

ERLOTINIB HYDROCHLORIDE - TARCEVA

N021743 003 5747498
Nov
6900221
Nov
6900221
Nov
6900221
Nov
7087613
Nov
7087613
Nov
RE41065
Nov

08,
09,
09,
09,
09,
09,
08,

2018
2020
2020
2020
2020
2020
2018

DS
DS
DS
DS

DP
DP
DP
DP

DS

DP

ERTAPENEM SODIUM - INVANZ

N021337 001 5478820
5478820*PED
5652233
5652233*PED
5952323
5952323*PED
7342005
7342005*PED

21,
21,
02,
02,
15,
15,
02,
02,

2015
2016
2013
2013
2017
2017
2013
2013

DS

DP

U-160

DS

DP

U-160

Nov
May
Feb
Aug
May
Nov
Feb
Aug

NCE

Nov

15, 2015

U-659
U-875
U-659
U-1046
U-659
U-1045

I-624
M-79

Apr
Sep

16, 2013
19, 2011

U-659
U-875
U-659
U-1046
U-659
U-1045

I-624
M-79

Apr
Sep

16, 2013
19, 2011

U-659
U-875
U-1046
U-659
U-659
U-1045

I-624
M-79

Apr
Sep

16, 2013
19, 2011

U-1096
DP

DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 60 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ESCITALOPRAM OXALATE - LEXAPRO

N021323 001 6916941
6916941*PED
7420069
7420069*PED
RE34712
RE34712*PED

Aug
Feb
Aug
Feb
Sep
Mar

12,
12,
12,
12,
14,
14,

2022
2023
2022
2023
2011
2012

DS
DS

DP
DP
DP

DS

DP

ESCITALOPRAM OXALATE - LEXAPRO

N021323 002 6916941
6916941*PED
7420069
7420069*PED
RE34712
RE34712*PED

Aug
Feb
Aug
Feb
Sep
Mar

12,
12,
12,
12,
14,
14,

2022
2023
2022
2023
2011
2012

DS
DS

DP
DP
DP

DS

DP

ESCITALOPRAM OXALATE - LEXAPRO

N021323 003 6916941
6916941*PED
7420069
7420069*PED
RE34712
RE34712*PED

Aug
Feb
Aug
Feb
Sep
Mar

12,
12,
12,
12,
14,
14,

2022
2023
2022
2023
2011
2012

DS
DS

DP
DP
DP

DS

DP

ESCITALOPRAM OXALATE - LEXAPRO

N021365 001 RE34712
Sep
Mar
RE34712*PED

14, 2011
14, 2012

DS

DP

ESMOLOL HYDROCHLORIDE - BREVIBLOC

N019386 006 6310094
Jan
6310094*PED
Jul
6528540
Jan
6528540*PED
Jul

12,
12,
12,
12,

2021
2021
2021
2021

ESMOLOL HYDROCHLORIDE - BREVIBLOC

N019386 007 6310094
Jan
6310094*PED
Jul
6528540
Jan
6528540*PED
Jul

12,
12,
12,
12,

2021
2021
2021
2021

PATENT
DELIST
REQUESTED

ESMOLOL HYDROCHLORIDE - BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

N019386 005 6310094
Jan 12, 2021
6310094*PED
Jul 12, 2021
6528540
Jan 12, 2021
6528540*PED
Jul 12, 2021
ESMOLOL HYDROCHLORIDE - BREVIBLOC IN PLASTIC CONTAINER
N019386 004 6310094
Jan 12, 2021
6310094*PED
Jul 12, 2021
6528540
Jan 12, 2021
6528540*PED
Jul 12, 2021

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NPP

Mar

19, 2012

NPP

Mar

19, 2012

NPP

Mar

19, 2012

NPP

Mar

19, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 61 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N021153 001 5690960
Nov
5690960
Nov
5690960
Nov
5690960*PED
May
Feb
5714504
Feb
5714504
Feb
5714504
Aug
5714504*PED
May
5877192
May
5877192
May
5877192
Nov
5877192*PED
May
5900424
May
5900424
May
5900424
Nov
5900424*PED
Oct
6147103
Apr
6147103*PED
Oct
6166213
Apr
6166213*PED
Oct
6191148
Apr
6191148*PED
May
6369085
May
6369085
Nov
6369085*PED
Nov
6428810
Nov
6428810
Nov
6428810
May
6428810*PED
May
6875872
Nov
6875872*PED
May
7411070
Nov
7411070*PED

25,
25,
25,
25,
03,
03,
03,
03,
27,
27,
27,
27,
04,
04,
04,
04,
09,
09,
09,
09,
09,
09,
25,
25,
25,
03,
03,
03,
03,
27,
27,
25,
25,

2014
2014
2014
2015
2015
2015
2015
2015
2014
2014
2014
2014
2016
2016
2016
2016
2018
2019
2018
2019
2018
2019
2018
2018
2018
2019
2019
2019
2020
2014
2014
2018
2018

ESOMEPRAZOLE MAGNESIUM - NEXIUM

N021153 002 5690960
Nov
5690960
Nov
5690960
Nov
5690960*PED
May
Feb
5714504
Feb
5714504
Feb
5714504
Aug
5714504*PED
May
5877192
May
5877192
May
5877192
Nov
5877192*PED
May
5900424
May
5900424
May
5900424
Nov
5900424*PED
Oct
6147103
Apr
6147103*PED
Oct
6166213
Apr
6166213*PED
Oct
6191148
Apr
6191148*PED
May
6369085
May
6369085
Nov
6369085*PED
Nov
6428810
Nov
6428810
Nov
6428810
May
6428810*PED
May
6875872
Nov
6875872*PED
May
7411070
Nov
7411070*PED

25,
25,
25,
25,
03,
03,
03,
03,
27,
27,
27,
27,
04,
04,
04,
04,
09,
09,
09,
09,
09,
09,
25,
25,
25,
03,
03,
03,
03,
27,
27,
25,
25,

2014
2014
2014
2015
2015
2015
2015
2015
2014
2014
2014
2014
2016
2016
2016
2016
2018
2019
2018
2019
2018
2019
2018
2018
2018
2019
2019
2019
2020
2014
2014
2018
2018

PATENT
CODES
DP
DP
DP
DP
DP
DP
DP
DP
DP
DS
DS
DS

DS
DS

U-373
U-729
U-770
U-373
U-729
U-770
U-373
U-373
U-729
U-770
U-373
U-373
U-729
U-770
U-373
U-373

DP
DP

U-770
U-729

DP
DP
DP

U-770
U-469
U-729
U-469

DP
DP
DP

U-770
U-373
U-729
U-373
U-770
U-729
U-373
U-373
U-770
U-729
U-373
U-373
U-770
U-373
U-729
U-373

DS
DS

DP
DP
DP
DP
DP
DP
DS
DS
DS

DS
DS

DS
DS

DP
DP

U-729
U-770

DP
DP
DP

U-770
U-729
U-469
U-469

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 62 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ESOMEPRAZOLE MAGNESIUM - NEXIUM

Nov
N021957 001 5690960
Nov
5690960
Nov
5690960
May
5690960*PED
Feb
5714504
Feb
5714504
Feb
5714504
Aug
5714504*PED
May
5877192
May
5877192
Nov
5877192*PED
May
5900424
May
5900424
May
5900424
Nov
5900424*PED
May
6369085
May
6369085
May
6369085
Nov
6369085*PED
Nov
6428810
Nov
6428810
Nov
6428810
May
6428810*PED
May
6875872
Nov
6875872*PED
May
7411070
Nov
7411070*PED

25,
25,
25,
25,
03,
03,
03,
03,
27,
27,
27,
04,
04,
04,
04,
25,
25,
25,
25,
03,
03,
03,
03,
27,
27,
25,
25,

2014
2014
2014
2015
2015
2015
2015
2015
2014
2014
2014
2016
2016
2016
2016
2018
2018
2018
2018
2019
2019
2019
2020
2014
2014
2018
2018

ESOMEPRAZOLE MAGNESIUM - NEXIUM

Nov
N021957 002 5690960
Nov
5690960
Nov
5690960
May
5690960*PED
Feb
5714504
Feb
5714504
Feb
5714504
Aug
5714504*PED
May
5877192
May
5877192
Nov
5877192*PED
May
5900424
May
5900424
May
5900424
Nov
5900424*PED
May
6369085
May
6369085
May
6369085
Nov
6369085*PED
Nov
6428810
Nov
6428810
Nov
6428810
May
6428810*PED
May
6875872
Nov
6875872*PED
May
7411070
Nov
7411070*PED

25,
25,
25,
25,
03,
03,
03,
03,
27,
27,
27,
04,
04,
04,
04,
25,
25,
25,
25,
03,
03,
03,
03,
27,
27,
25,
25,

2014
2014
2014
2015
2015
2015
2015
2015
2014
2014
2014
2016
2016
2016
2016
2018
2018
2018
2018
2019
2019
2019
2020
2014
2014
2018
2018

PATENT
CODES
DP
DP
DP

U-1207
U-729
U-773

DP
DP
DP

U-729
U-773
U-1207

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

M-86
PED
PED

Jun
Aug
Dec

18, 2012
27, 2011
18, 2012

M-86
PED
PED

Jun
Aug
Dec

18, 2012
27, 2011
18, 2012

U-773
U-729
DS
DS
DS
DS
DS
DS

U-1207
U-729
U-773
DP
DP
DP

U-729
U-773
U-1207

DP
DP
DP

U-729
U-773
U-1207

DP
DP
DP

U-1207
U-729
U-773

DP
DP
DP

U-1207
U-729
U-773

DS
DS

U-729
U-773
DS
DS
DS
DS
DS
DS

DS
DS

U-1207
U-773
U-729
DP
DP
DP

U-1207
U-729
U-773

DP
DP
DP

U-1207
U-729
U-773

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 63 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ESOMEPRAZOLE MAGNESIUM - NEXIUM

Nov
N022101 001 5690960
May
5690960*PED
Feb
5714504
Aug
5714504*PED
May
5877192
Nov
5877192*PED
May
5900424
Nov
5900424*PED
May
6369085
Nov
6369085*PED
Nov
6428810
May
6428810*PED
May
6875872
Nov
6875872*PED
May
7411070
Nov
7411070*PED

25,
25,
03,
03,
27,
27,
04,
04,
25,
25,
03,
03,
27,
27,
25,
25,

2014
2015
2015
2015
2014
2014
2016
2016
2018
2018
2019
2020
2014
2014
2018
2018

ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO

Feb 03, 2015
N022511 001 5714504
Aug 03, 2015
5714504*PED
May 04, 2016
5900424
Nov 04, 2016
5900424*PED
May 25, 2018
6369085
Nov 25, 2018
6369085*PED
May 27, 2014
6875872
Nov 27, 2014
6875872*PED
Feb 28, 2023
6926907
May 25, 2018
7411070
Nov 25, 2018
7411070*PED
Oct 13, 2018
7745466
ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO
N022511 002 5714504
Feb 03, 2015
5714504*PED
Aug 03, 2015
5900424
May 04, 2016
Nov 04, 2016
5900424*PED
May 25, 2018
6369085
6369085*PED
Nov 25, 2018
6875872
May 27, 2014
Nov 27, 2014
6875872*PED
Feb 28, 2023
6926907
May 25, 2018
7411070
Nov 25, 2018
7411070*PED
Oct 13, 2018
7745466

PATENT
CODES
DP

U-858

DP

U-858

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

M-86
PED
PED

Jun
Dec
Aug

18, 2012
18, 2012
27, 2011

NC

Apr

30, 2013

NC

Apr

30, 2013

U-858
DS
DS

U-858
DP

U-858

DP

U-858

DP

U-1053

DS
DS

DS
DS

U-1053
DP

U-1053

DP

U-1052
U-1053

DP

U-1053

DP

U-1053

DS

DS

DS
DS

U-1053
DP

U-1053

DP

U-1052
U-1053

DP

U-1053

DS

DS

ESOMEPRAZOLE SODIUM - NEXIUM IV

May
N021689 001 5877192
Nov
5877192*PED
May
6143771

27, 2014
27, 2014
27, 2014

ESOMEPRAZOLE SODIUM - NEXIUM IV

N021689 002 5877192
May
Nov
5877192*PED
May
6143771

27, 2014
27, 2014
27, 2014

DP

ESTRADIOL - ELESTRIN
N021813 001 7198801
7470433

Jun
Aug

25, 2022
03, 2021

DP
DP

ESTRADIOL - EVAMIST
N022014 001 6299900
6299900
6818226
6818226
6923983
6923983
6978945

Feb
Feb
Feb
Feb
Feb
Feb
Nov

19,
19,
19,
19,
19,
19,
30,

DP
DP
DP
DP
DP
DP
DP

2017
2017
2017
2017
2017
2017
2021

PATENT
DELIST
REQUESTED

U-643
DP

U-643

U-643
U-643

U-889
U-888
U-888
U-889
U-888
U-889

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 64 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ESTRADIOL - MENOSTAR
N021674 001 5891868
6692763

Nov
Nov

21, 2017
21, 2017

ESTRADIOL - VAGIFEM
N020908 002 7018992

Sep

17, 2022

ESTRADIOL - VIVELLE-DOT
N020538 005 5474783
5656286
5958446
6024976

Dec
Aug
Dec
Jan

12,
12,
12,
07,

2012
2014
2012
2014

ESTRADIOL - VIVELLE-DOT
N020538 006 5474783
5656286
5958446
6024976

Dec
Aug
Dec
Jan

12,
12,
12,
07,

2012
2014
2012
2014

ESTRADIOL - VIVELLE-DOT
N020538 007 5474783
5656286
5958446
6024976

Dec
Aug
Dec
Jan

12,
12,
12,
07,

2012
2014
2012
2014

ESTRADIOL - VIVELLE-DOT
N020538 008 5474783
5656286
5958446
6024976

Dec
Aug
Dec
Jan

12,
12,
12,
07,

2012
2014
2012
2014

ESTRADIOL - VIVELLE-DOT
N020538 009 5474783
5656286
5958446
6024976

Dec
Aug
Dec
Jan

12,
12,
12,
07,

2012
2014
2012
2014

ESTRADIOL ACETATE - FEMRING

N021367 001 5855906

Dec

19, 2015

U-508

ESTRADIOL ACETATE - FEMRING

N021367 002 5855906

Dec

19, 2015

U-508

ESTRADIOL ACETATE - FEMTRACE

N021633 001 6962908
7572779
7799771

Dec
Oct
Dec

21, 2021
02, 2025
21, 2021

DP

ESTRADIOL ACETATE - FEMTRACE

N021633 002 6962908
7572779
7799771

Dec
Oct
Dec

21, 2021
02, 2025
21, 2021

DP

ESTRADIOL ACETATE - FEMTRACE

N021633 003 6962908
7572779
7799771

Dec
Oct
Dec

21, 2021
02, 2025
21, 2021

DP

ESTRADIOL HEMIHYDRATE - ESTRASORB

N021371 001 5629021
Jan

31, 2015

DP

ESTRADIOL; LEVONORGESTREL - CLIMARA PRO

N021258 001 5676968
Oct 14, 2014

DP

ESTRADIOL; NORETHINDRONE ACETATE - COMBIPATCH

Dec 12, 2012
N020870 001 5474783
Aug 12, 2014
5656286
Dec 12, 2012
5958446
Jan 07, 2014
6024976

DP
DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-594
U-594

U-1023

DP
DP
DP
DP

U-904
DP

U-904
DP

U-904
DP

PATENT
DELIST
REQUESTED

D-122

Nov

25, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 65 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ESTRADIOL; NORETHINDRONE ACETATE - COMBIPATCH

N020870 002 5474783
Dec 12, 2012
5656286
Aug 12, 2014
Dec 12, 2012
5958446
Jan 07, 2014
6024976
ESTRADIOL; NORGESTIMATE - PREFEST
N021040 001 5382573
Jan
6747019
Mar
7320970
Mar

17, 2012
20, 2020
30, 2020

DP

U-311
U-844

ESTROGENS, CONJUGATED - PREMARIN

N020216 001
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N020992 001 5908638
Jul 26, 2015

I-579

Nov

07, 2011

NP

Nov

28, 2011

DP

ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN

N020992 002 5908638
Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N020992 003 5908638
Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N020992 004 5908638
Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N020992 005 5908638
Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - SYNTHETIC CONJUGATED ESTROGENS A
N021788 001
ESTROGENS, CONJUGATED SYNTHETIC B N021443 001 6660726
Mar
6660726
Mar
6855703
Feb
6855703
Feb

ENJUVIA
08, 2021
08, 2021
12, 2021
12, 2021

DS
DS
DS
DS

DP
DP
DP
DP

U-904
U-905
U-904
U-905

ESTROGENS, CONJUGATED SYNTHETIC B N021443 002 6660726

Mar
6660726
Mar
6855703
Feb
6855703
Feb

ENJUVIA
08, 2021
08, 2021
12, 2021
12, 2021

DS
DS
DS
DS

DP
DP
DP
DP

U-904
U-905
U-905
U-904

ESTROGENS, CONJUGATED SYNTHETIC B N021443 003 6660726

Mar
6660726
Mar
6855703
Feb
6855703
Feb

ENJUVIA
08, 2021
08, 2021
12, 2021
12, 2021

DS
DS
DS
DS

DP
DP
DP
DP

U-905
U-904
U-904
U-905

ESTROGENS, CONJUGATED SYNTHETIC B N021443 004 6660726

Mar
6660726
Mar
6855703
Feb
6855703
Feb

ENJUVIA
08, 2021
08, 2021
12, 2021
12, 2021

DS
DS
DS
DS

DP
DP
DP
DP

U-904
U-905
U-904
U-905

ESTROGENS, CONJUGATED SYNTHETIC B N021443 005 6660726

Mar
6660726
Mar
6855703
Feb
6855703
Feb

ENJUVIA
08, 2021
08, 2021
12, 2021
12, 2021

DS
DS
DS
DS

DP
DP
DP
DP

U-905
U-904
U-904
U-905

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPHASE 14/14

N020527 002 5547948
Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO
N020527 001 5547948
Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO
N020527 003 5547948
Jan 17, 2015

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 66 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO

N020527 004 5547948
Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO
N020527 005 5547948
Jan 17, 2015
ESZOPICLONE - LUNESTA
N021476 001 6319926
6444673
6864257
7381724

Jan
Feb
Aug
Jan

16,
14,
30,
16,

2012
2014
2012
2012

ESZOPICLONE - LUNESTA
N021476 002 6319926
6444673
6864257
7381724

Jan
Feb
Aug
Jan

16,
14,
30,
16,

2012
2014
2012
2012

ESZOPICLONE - LUNESTA
N021476 003 6319926
6444673
6864257
7381724

Jan
Feb
Aug
Jan

16,
14,
30,
16,

2012
2014
2012
2012

U-620
DS

DP

DS

DP

DS

DP

DS

DP

DS

DP

DS

DP

U-629
U-629

U-620
U-629
U-629

U-620
U-629
U-629

ETHINYL ESTRADIOL; ETONOGESTREL - NUVARING

N021187 001 5989581
Apr 08, 2018
ETHINYL ESTRADIOL; LEVONORGESTREL N022262 001 7615545
Jun
7855190
Dec
7858605
Jun

LOSEASONIQUE
15, 2023
05, 2028
23, 2023

U-1
U-1

NP

Oct

24, 2011

ETHINYL ESTRADIOL; NORETHINDRONE - NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
A078965 001
PC
Sep

21, 2011

DP

ETHINYL ESTRADIOL; LEVONORGESTREL - LYBREL

N021864 001 6500814
Sep 03, 2018

U-1

ETHINYL ESTRADIOL; LEVONORGESTREL - PREVEN EMERGENCY CONTRACEPTIVE KIT

N020946 001 6156742
Dec 05, 2020
U-374
ETHINYL ESTRADIOL; LEVONORGESTREL - SEASONALE
N021544 001 5898032
Jun 23, 2017
RE39861
Jun 23, 2017
ETHINYL ESTRADIOL; LEVONORGESTREL N021840 001 7320969
Jan
7615545
Jun
7855190
Dec
7858605
Jun

SEASONIQUE
30, 2024
15, 2023
05, 2028
23, 2023

ETHINYL ESTRADIOL; NORELGESTROMIN - ORTHO EVRA

N021180 001 5876746
Nov 20, 2015
5972377
Jun 07, 2015
ETHINYL ESTRADIOL; NORETHINDRONE - FEMCON FE
N021490 001 6667050
Apr 06, 2019

U-1
U-828

U-828
U-1
U-1
DP

DP

U-514
U-514

DP

U-1

ETHINYL ESTRADIOL; NORETHINDRONE - NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
N022573 001 5552394
Jul 22, 2014
U-828
NP
Dec
DP U-828
6667050
Apr 06, 2019

22, 2013

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LO LOESTRIN FE

N022501 001 5552394
Jul 22, 2014
U-1090
U-1090
7704984
Feb 02, 2029

21, 2013

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LOESTRIN 24 FE

N021871 001 5552394
Jul 22, 2014
U-1

NP

Oct

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 67 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ETHINYL ESTRADIOL; NORGESTIMATE - ORTHO TRI-CYCLEN LO

N021241 001 6214815
Jun 09, 2019
6214815*PED
Dec 09, 2019

U-112

ETRAVIRINE - INTELENCE
N022187 001 6878717
6878717
7037917
7037917
7887845
8003789

Nov
Nov
Dec
Dec
Mar
Nov

05,
05,
13,
13,
25,
01,

2019
2019
2020
2020
2019
2019

U-256
U-1016
U-256
U-1016

NCE

Jan

18, 2013

ETRAVIRINE - INTELENCE
N022187 002 6878717
7037917
7887845
8003789

Nov
Dec
Mar
Nov

05,
13,
25,
01,

2019
2020
2019
2019

U-1016
U-1016

NCE

Jan

18, 2013

EVEROLIMUS - AFINITOR
N022334 001 5665772
6004973
7297703

Sep
Jul
Dec

EVEROLIMUS - AFINITOR
N022334 002 5665772
6004973
7297703

DS
DS

DP
DP
DP

DS

DP
DP

09, 2019
12, 2016
06, 2019

DS

DP
DP
DP

I-638
I-630
NCE
ODE
ODE

May
Oct
Mar
May
Oct

05,
29,
30,
05,
29,

2014
2013
2014
2018
2017

Sep
Jul
Dec

09, 2019
12, 2016
06, 2019

DS

DP
DP
DP

I-638
I-630
NCE
ODE
ODE

May
Oct
Mar
May
Oct

05,
29,
30,
05,
29,

2014
2013
2014
2018
2017

EVEROLIMUS - AFINITOR
N022334 003 5665772

Sep

09, 2019

I-638
I-630
NCE
ODE
ODE

May
Oct
Mar
May
Oct

05,
29,
30,
05,
29,

2014
2013
2014
2018
2017

EVEROLIMUS - ZORTRESS
N021560 001 5665772
6004973
6239124
6440990
6455518

Sep
Jul
Aug
Sep
Jul

09,
12,
11,
24,
29,

2019
2016
2017
2013
2017

DS

U-1049
U-1049
U-1049
U-1049
U-1049

NP
NCE

Apr
Mar

20, 2013
30, 2014

EVEROLIMUS - ZORTRESS
N021560 002 5665772
6004973
6239124
6440990
6455518

Sep
Jul
Aug
Sep
Jul

09,
12,
11,
24,
29,

2019
2016
2017
2013
2017

DS

U-1049
U-1049
U-1049
U-1049
U-1049

NP
NCE

Apr
Mar

20, 2013
30, 2014

EVEROLIMUS - ZORTRESS
N021560 003 5665772
6004973
6239124
6440990
6455518

Sep
Jul
Aug
Sep
Jul

09,
12,
11,
24,
29,

2019
2016
2017
2013
2017

DS

U-1049
U-1049
U-1049
U-1049
U-1049

NP
NCE

Apr
Mar

20, 2013
30, 2014

DP
DP
DP

DP
DP
DP

DP
DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 68 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

EXENATIDE SYNTHETIC - BYETTA

N021773 001 5424286
5424286
6858576
6872700
6902744
6956026
7297761
7521423
7741269

Dec
Dec
Jan
Jan
Jan
Jan
Oct
Oct
Jan

01,
01,
06,
14,
14,
07,
15,
15,
07,

2016
2016
2017
2020
2020
2018
2017
2017
2018

EXENATIDE SYNTHETIC - BYETTA

N021773 002 5424286
5424286
6858576
6872700
6902744
6956026
7297761
7521423
7741269

Dec
Dec
Jan
Jan
Jan
Jan
Oct
Oct
Jan

01,
01,
06,
14,
14,
07,
15,
15,
07,

2016
2016
2017
2020
2020
2018
2017
2017
2018

EZETIMIBE - ZETIA
N021445 001 5846966
5846966
5846966
5846966*PED
7030106
7030106*PED
7612058
7612058
7612058*PED
RE37721
RE37721*PED
RE42461
RE42461
RE42461*PED

Sep
Sep
Sep
Mar
Jan
Jul
Jan
Jan
Jul
Oct
Apr
Oct
Oct
Apr

21,
21,
21,
21,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,

2013
2013
2013
2014
2022
2022
2022
2022
2022
2016
2017
2016
2016
2017

EZETIMIBE; SIMVASTATIN - VYTORIN

Sep
N021687 001 5846966
Sep
5846966
Mar
5846966*PED
Oct
RE37721
Apr
RE37721*PED
Oct
RE42461
Apr
RE42461*PED

21,
21,
21,
25,
25,
25,
25,

2013
2013
2014
2016
2017
2016
2017

EZETIMIBE; SIMVASTATIN - VYTORIN

N021687 002 5846966
Sep
Sep
5846966
Mar
5846966*PED
Oct
RE37721
Apr
RE37721*PED
Oct
RE42461
Apr
RE42461*PED

21,
21,
21,
25,
25,
25,
25,

2013
2013
2014
2016
2017
2016
2017

EZETIMIBE; SIMVASTATIN - VYTORIN

N021687 003 5846966
Sep
Sep
5846966
Mar
5846966*PED
Oct
RE37721
Apr
RE37721*PED
Oct
RE42461
Apr
RE42461*PED

21,
21,
21,
25,
25,
25,
25,

2013
2013
2014
2016
2017
2016
2017

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-653
U-1108
U-656
U-654
DP
U-687
DP
DP
U-1074

U-1108
U-653
U-656
U-654
DP
U-687
DP
DP
U-1074

U-1172
U-474
U-473

PED

Dec

05, 2011

PED

Dec

05, 2011

PED

Dec

05, 2011

DP
U-1027
U-1173
DS

DP

U-473

DS
DS

DP
DP

U-1173
U-473

DP
DP

U-473
U-593

DS

DP

U-473

DS

DP

U-473

DP
DP

U-473
U-593

DS

DP

U-473

DS

DP

U-473

DP
DP

U-473
U-593

DS

DP

U-473

DS

DP

U-473

Y
Y

Y
Y

Y
Y

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 69 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

EZETIMIBE; SIMVASTATIN - VYTORIN

Sep
N021687 004 5846966
Sep
5846966
Mar
5846966*PED
Oct
RE37721
Apr
RE37721*PED
Oct
RE42461
Apr
RE42461*PED

21,
21,
21,
25,
25,
25,
25,

2013
2013
2014
2016
2017
2016
2017

PATENT
CODES
DP
DP

U-473
U-593

DS

DP

U-473

DS

DP

U-473

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

PED

Dec

05, 2011

EZOGABINE - POTIGA
N022345 001

NCE

Jun

10, 2016

EZOGABINE - POTIGA
N022345 002

NCE

Jun

10, 2016

EZOGABINE - POTIGA
N022345 003

NCE

Jun

10, 2016

EZOGABINE - POTIGA
N022345 004

NCE

Jun

10, 2016

M-98
M-54
PED

Jan
Dec
Jun

31, 2014
24, 2012
24, 2013

M-98
M-54
PED

Jan
Dec
Jun

31, 2014
24, 2012
24, 2013

M-98
M-54
PED

Jan
Dec
Jun

31, 2014
24, 2012
24, 2013

FAMCICLOVIR - FAMVIR
N020363 001 5840763
5840763*PED
5866581
5866581*PED
5916893
5916893*PED
6124304
6124304*PED

Sep
Mar
Oct
Apr
Sep
Mar
Oct
Apr

01,
01,
04,
04,
01,
01,
04,
04,

2015
2016
2014
2015
2015
2016
2014
2015

U-96

FAMCICLOVIR - FAMVIR
N020363 002 5840763
5840763*PED
5866581
5866581*PED
5916893
5916893*PED
6124304
6124304*PED

Sep
Mar
Oct
Apr
Sep
Mar
Oct
Apr

01,
01,
04,
04,
01,
01,
04,
04,

2015
2016
2014
2015
2015
2016
2014
2015

U-96

FAMCICLOVIR - FAMVIR
N020363 003 5840763
5840763*PED
5866581
5866581*PED
5916893
5916893*PED
6124304
6124304*PED

Sep
Mar
Oct
Apr
Sep
Mar
Oct
Apr

01,
01,
04,
04,
01,
01,
04,
04,

2015
2016
2014
2015
2015
2016
2014
2015

U-96

FAMOTIDINE - FLUXID
N021712 001 6024981
6221392

Apr
Apr

09, 2018
09, 2018

DP
DP

FAMOTIDINE - FLUXID
N021712 002 6024981
6221392

Apr
Apr

09, 2018
09, 2018

DP
DP

FAMOTIDINE - PEPCID AC
N020325 001 5854267
5854267*PED

Dec
Jun

29, 2015
29, 2016

FAMOTIDINE - PEPCID AC
N020801 001 5667794
5667794*PED
5854267
5854267*PED

May
Nov
Dec
Jun

02,
02,
29,
29,

2015
2015
2015
2016

Y
Y

U-96
U-96
U-96

U-96
U-96
U-96

U-96
U-96
U-96

U-267
U-267

Y
U-267

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 70 of 207

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
N020801 002 6814978
6814978*PED

PATENT
EXPIRATION
DATE

PATENT
CODES

Aug
Feb

26, 2021
26, 2022

FAMOTIDINE - PEPCID AC (GELTAB)

N020902 001 5854267
Dec
5854267*PED
Jun

29, 2015
29, 2016

FAMOTIDINE; IBUPROFEN - DUEXIS

N022519 001 8067033
Jul
8067451
Jul

18, 2026
18, 2026

FEBUXOSTAT - ULORIC
N021856 001 5614520
6225474
7361676

Mar
Jun
Mar

25, 2014
18, 2019
08, 2024

DS
DS

FEBUXOSTAT - ULORIC
N021856 002 5614520
6225474
7361676

Mar
Jun
Mar

25, 2014
18, 2019
08, 2024

DS
DS

FENOFIBRATE - ANTARA (MICRONIZED)

N021695 001 7101574
Aug
7863331
Aug
7863331
Aug

20, 2020
08, 2020
08, 2020

DS

FENOFIBRATE - ANTARA (MICRONIZED)

N021695 003 7101574
Aug
7863331
Aug
7863331
Aug

20, 2020
08, 2020
08, 2020

DS

FENOFIBRATE - FENOGLIDE
N022118 001 7658944

Dec

09, 2024

DP

FENOFIBRATE - FENOGLIDE
N022118 002 7658944

Dec

09, 2024

DP

FENOFIBRATE - LIPOFEN
N021612 001 5545628

Jan

10, 2015

DP

U-701

FENOFIBRATE - LIPOFEN
N021612 002 5545628

Jan

10, 2015

DP

U-701

FENOFIBRATE - LIPOFEN
N021612 003 5545628

Jan

10, 2015

DP

U-701

FENOFIBRATE - TRICOR
N021203 001 6074670
6277405
6589552
6652881
7037529
7041319

Jan
Jan
Jan
Jan
Jan
Jan

09,
09,
09,
09,
09,
09,

2018
2018
2018
2018
2018
2018

DP
DP
DP

FENOFIBRATE - TRICOR
N021203 003 6074670
6277405
6589552
6652881
7037529
7041319

Jan
Jan
Jan
Jan
Jan
Jan

09,
09,
09,
09,
09,
09,

2018
2018
2018
2018
2018
2018

DP
DP
DP

FENOFIBRATE - TRICOR
N021656 001 6277405
6375986
6652881
7037529
7041319
7276249
7320802

Jan
Sep
Jan
Jan
Jan
Feb
Feb

09,
21,
09,
09,
09,
21,
21,

2018
2020
2018
2018
2018
2023
2023

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP

U-368
U-368

DP
DP

U-1196

DP

NC

Apr

23, 2014

U-954

NCE

Feb

13, 2014

U-954

NCE

Feb

13, 2014

DP

DP
DP

DP
U-1107
U-1106

DP
U-1106
U-1107

DS
DP

U-615

DS
DP
DP
DP
U-847

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 71 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

FENOFIBRATE - TRICOR
N021656 002 6277405
6375986
6652881
7037529
7041319
7276249
7320802

Jan
Sep
Jan
Jan
Jan
Feb
Feb

09,
21,
09,
09,
09,
21,
21,

2018
2020
2018
2018
2018
2023
2023

DS

FENOFIBRATE - TRIGLIDE
N021350 001 6696084

Sep

11, 2021

DS

DP

U-680

FENOFIBRATE - TRIGLIDE
N021350 002 6696084

Sep

11, 2021

DS

DP

U-680

FENOFIBRIC ACID - FIBRICOR

N022418 001 7569612
7741373
7741374
7741374
7915247
7915247
7915247

Aug
Aug
Aug
Aug
Aug
Aug
Aug

20,
20,
20,
20,
20,
20,
20,

2027
2027
2027
2027
2027
2027
2027

U-1000
U-1059
U-1061
U-1060
U-1061
U-1059
U-1000

FENOFIBRIC ACID - FIBRICOR

N022418 002 7569612
7741373
7741374
7741374
7915247
7915247
7915247

Aug
Aug
Aug
Aug
Aug
Aug
Aug

20,
20,
20,
20,
20,
20,
20,

2027
2027
2027
2027
2027
2027
2027

U-1000
U-1059
U-1061
U-1060
U-1061
U-1059
U-1000

FENTANYL CITRATE - ABSTRAL

N022510 001 6759059
6761910
7910132

Sep
Sep
Sep

24, 2019
24, 2019
24, 2019

DP
DP
DP

U-767
U-767
U-767

FENTANYL CITRATE - ABSTRAL

N022510 002 6759059
6761910
7910132

Sep
Sep
Sep

24, 2019
24, 2019
24, 2019

DP
DP
DP

U-767
U-767
U-767

FENTANYL CITRATE - ABSTRAL

N022510 003 6759059
6761910
7910132

Sep
Sep
Sep

24, 2019
24, 2019
24, 2019

DP
DP
DP

U-767
U-767
U-767

FENTANYL CITRATE - ABSTRAL

N022510 004 6759059
6761910
7910132

Sep
Sep
Sep

24, 2019
24, 2019
24, 2019

DP
DP
DP

U-767
U-767
U-767

FENTANYL CITRATE - ABSTRAL

N022510 005 6759059
6761910
7910132

Sep
Sep
Sep

24, 2019
24, 2019
24, 2019

DP
DP
DP

U-767
U-767
U-767

FENTANYL CITRATE - ABSTRAL

N022510 006 6759059
6761910
7910132

Sep
Sep
Sep

24, 2019
24, 2019
24, 2019

DP
DP
DP

U-767
U-767
U-767

FENTANYL CITRATE - FENTORA

N021947 001 6200604
6974590
7862832
7862833

Mar
Mar
Jun
Jun

26,
26,
15,
15,

2019
2019
2028
2028

DP

U-615

DS
DP
DP
DP
U-847

U-767
U-767
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 72 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

FENTANYL CITRATE - FENTORA

N021947 002 6200604
6974590
7862832
7862833

Mar
Mar
Jun
Jun

26,
26,
15,
15,

2019
2019
2028
2028

FENTANYL CITRATE - FENTORA

N021947 003 6200604
6974590
7862832
7862833

Mar
Mar
Jun
Jun

26,
26,
15,
15,

2019
2019
2028
2028

FENTANYL CITRATE - FENTORA

N021947 004 6200604
6974590
7862832
7862833

Mar
Mar
Jun
Jun

26,
26,
15,
15,

2019
2019
2028
2028

FENTANYL CITRATE - FENTORA

N021947 005 6200604
6974590
7862832
7862833

Mar
Mar
Jun
Jun

26,
26,
15,
15,

2019
2019
2028
2028

FENTANYL CITRATE - FENTORA

N021947 006 6200604
6974590

Mar
Mar

26, 2019
26, 2019

FENTANYL CITRATE - LAZANDA

N022569 001 6432440

Apr

20, 2018

DP

U-1169

NDF

Jun

30, 2014

FENTANYL CITRATE - LAZANDA

N022569 002 6432440

Apr

20, 2018

DP

U-1169

NDF

Jun

30, 2014

FENTANYL CITRATE - ONSOLIS

N022266 001 6159498
7579019

Oct
Jan

18, 2016
31, 2019

DP

NP

Jul

16, 2012

FENTANYL CITRATE - ONSOLIS

N022266 002 6159498
7579019

Oct
Jan

18, 2016
31, 2019

DP

NP

Jul

16, 2012

FENTANYL CITRATE - ONSOLIS

N022266 003 6159498
7579019

Oct
Jan

18, 2016
31, 2019

DP

NP

Jul

16, 2012

FENTANYL CITRATE - ONSOLIS

N022266 004 6159498
7579019

Oct
Jan

18, 2016
31, 2019

DP

NP

Jul

16, 2012

FENTANYL CITRATE - ONSOLIS

N022266 005 6159498
7579019

Oct
Jan

18, 2016
31, 2019

DP

NP

Jul

16, 2012

16,
01,
02,
05,
02,
28,
05,
02,
05,
02,
19,
01,
05,
26,
05,

DP
DP
DP

FENTANYL HYDROCHLORIDE - IONSYS

Dec
N021338 001 5697896
Dec
5843014
Jan
6169920
Jun
6171294
Nov
6181963
Jan
6195582
Jun
6216033
Jun
6317629
Jun
6425892
Jun
6842640
Apr
6881208
Apr
6975902
Jun
7018370
Sep
7027859
Jun
7302293

2014
2015
2018
2015
2019
2019
2015
2012
2015
2015
2022
2024
2015
2014
2015

U-767
U-767
DP
DP

U-767
U-767
DP
DP

U-767
U-767
DP
DP

U-767
U-767
DP
DP

U-767
U-767

U-767

U-767

U-767

U-767

U-767

U-736
DP
DP
DP
DP

U-736

U-736
DP
U-736
DP
U-736
DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 73 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

FERUMOXYTOL - FERAHEME
N022180 001 6599498
7553479
7871597

PATENT
EXPIRATION
DATE

PATENT
CODES

08, 2020
08, 2020
08, 2020

DS
DS
DS

FESOTERODINE FUMARATE - TOVIAZ

N022030 001 6858650
May
May
7384980
Jun
7807715
May
7855230
May
7985772

11,
11,
07,
11,
11,

2019
2019
2027
2019
2019

DS
DS

FESOTERODINE FUMARATE - TOVIAZ

May
N022030 002 6858650
May
7384980
Jun
7807715
May
7855230
May
7985772

11,
11,
07,
11,
11,

2019
2019
2027
2019
2019

DS
DS

Mar
Mar
Mar

FEXOFENADINE HYDROCHLORIDE - ALLEGRA

Nov 26, 2013
N020625 001 5578610
May 26, 2014
5578610*PED
Feb 28, 2015
5738872
Aug 28, 2015
5738872*PED
Feb 28, 2015
5855912
Aug 28, 2015
5855912*PED
Feb 28, 2015
5932247
Aug 28, 2015
5932247*PED
Mar 14, 2017
6037353
Sep 14, 2017
6037353*PED
Feb 28, 2015
6113942
Aug 28, 2015
6113942*PED
May 11, 2012
6187791
Nov 11, 2012
6187791*PED
May 11, 2012
6399632
Nov 11, 2012
6399632*PED
May 18, 2014
7135571
Nov 18, 2014
7135571*PED
May 18, 2014
7138524
Nov 18, 2014
7138524*PED
FEXOFENADINE HYDROCHLORIDE - ALLEGRA
N021963 001 5578610
Nov 26, 2013
6037353
Mar 14, 2017
6187791
May 11, 2012
May 11, 2012
6399632
May 18, 2014
7138524
Nov 18, 2014
7138524*PED
FEXOFENADINE HYDROCHLORIDE - ALLEGRA ALLERGY
Nov 26, 2013
N020872 007 5578610
May 26, 2014
5578610*PED
Feb 28, 2015
5855912
Aug 28, 2015
5855912*PED
Feb 28, 2015
5932247
Aug 28, 2015
5932247*PED
Mar 14, 2017
6037353
Sep 14, 2017
6037353*PED
Feb 28, 2015
6113942
Aug 28, 2015
6113942*PED
May 11, 2012
6187791
Nov 11, 2012
6187791*PED
May 11, 2012
6399632
Nov 11, 2012
6399632*PED
May 18, 2014
7135571
Nov 18, 2014
7135571*PED
May 18, 2014
7138524
Nov 18, 2014
7138524*PED

DS

DS

DP
DP
DP

DP
DP
DP

DP
DP
DP

30, 2012

U-913
U-913
U-913
U-913
U-913

NCE

Oct

31, 2013

U-913
U-913
U-913
U-913
U-913

NCE

Oct

31, 2013

U-138
U-138
U-468
U-468
DS
DS

DP

U-772
U-772
U-772
U-772

DP

U-1160

DS

DP
DP
U-1160
DP
U-1160
U-1160
DS
DS

EXCLUSIVITY
EXPIRATION
DATE

Jun

U-138
U-138

DS

EXCLUSIVITY
CODE(S)
NP

U-192
U-192

DS

PATENT
DELIST
REQUESTED

U-1160

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 74 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

FEXOFENADINE HYDROCHLORIDE - ALLEGRA ALLERGY

N020872 010 5578610
Nov 26, 2013
5578610*PED
May 26, 2014
Feb 28, 2015
5855912
Aug 28, 2015
5855912*PED
Feb 28, 2015
5932247
Aug 28, 2015
5932247*PED
Mar 14, 2017
6037353
Sep 14, 2017
6037353*PED
Feb 28, 2015
6113942
Aug 28, 2015
6113942*PED
May 11, 2012
6187791
Nov 11, 2012
6187791*PED
May 11, 2012
6399632
Nov 11, 2012
6399632*PED
May 18, 2014
7135571
Nov 18, 2014
7135571*PED
May 18, 2014
7138524
Nov 18, 2014
7138524*PED
FEXOFENADINE HYDROCHLORIDE - ALLEGRA HIVES
N020872 008 5578610
Nov 26, 2013
5578610*PED
May 26, 2014
Feb 28, 2015
5855912
Aug 28, 2015
5855912*PED
Feb 28, 2015
5932247
Aug 28, 2015
5932247*PED
Mar 14, 2017
6037353
Sep 14, 2017
6037353*PED
Feb 28, 2015
6113942
Aug 28, 2015
6113942*PED
May 11, 2012
6187791
Nov 11, 2012
6187791*PED
May 11, 2012
6399632
Nov 11, 2012
6399632*PED
May 18, 2014
7135571
Nov 18, 2014
7135571*PED
May 18, 2014
7138524
Nov 18, 2014
7138524*PED
FEXOFENADINE HYDROCHLORIDE - ALLEGRA HIVES
N020872 009 5578610
Nov 26, 2013
5578610*PED
May 26, 2014
Feb 28, 2015
5855912
Aug 28, 2015
5855912*PED
Feb 28, 2015
5932247
Aug 28, 2015
5932247*PED
Mar 14, 2017
6037353
Sep 14, 2017
6037353*PED
Feb 28, 2015
6113942
Aug 28, 2015
6113942*PED
May 11, 2012
6187791
Nov 11, 2012
6187791*PED
May 11, 2012
6399632
Nov 11, 2012
6399632*PED
May 18, 2014
7135571
Nov 18, 2014
7135571*PED
May 18, 2014
7138524
Nov 18, 2014
7138524*PED

PATENT
CODES
DS

DP

U-1160

DP
DP
U-1160
DP
U-1160
U-1160
DS

U-1160

DS

DS

DP

U-1160

DP
DP
U-1160
DP
U-1160
U-1160
DS

U-1160

DS

DS

DP

U-1160

DP
DP
U-1160
DP
U-1160
U-1160
DS
DS

U-1160

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 75 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA

Nov 26, 2013
N020872 005 5578610
May 26, 2014
5578610*PED
Feb 28, 2015
5855912
Aug 28, 2015
5855912*PED
Feb 28, 2015
5932247
Aug 28, 2015
5932247*PED
Mar 14, 2017
6037353
Sep 14, 2017
6037353*PED
Feb 28, 2015
6113942
Aug 28, 2015
6113942*PED
May 11, 2012
6187791
Nov 11, 2012
6187791*PED
May 11, 2012
6399632
Nov 11, 2012
6399632*PED
May 18, 2014
7135571
Nov 18, 2014
7135571*PED
May 18, 2014
7138524
Nov 18, 2014
7138524*PED

PATENT
CODES
ALLERGY
DS DP U-1160
DP
DP
U-1160
DP
U-1160
U-1160
DS

U-1160

DS

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY

Nov 26, 2013
DS DP U-1158
N021909 002 5578610
DP
Feb 28, 2015
5738872
U-1158
Mar 14, 2017
6037353
U-1158
May 11, 2012
6187791
U-1158
May 11, 2012
6399632
DS
May 18, 2014
7138524
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY
N201373 001 5578610
Nov 26, 2013
DS DP U-1157
5578610*PED
May 26, 2014
U-1157
Mar 14, 2017
6037353
Sep 14, 2017
6037353*PED
May 11, 2012
U-1157
6187791
Nov 11, 2012
6187791*PED
U-1157
May 11, 2012
6399632
Nov 11, 2012
6399632*PED
DS
May 18, 2014
7138524
Nov 18, 2014
7138524*PED
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA
N020872 006 5578610
Nov 26, 2013
5578610*PED
May 26, 2014
Feb 28, 2015
5855912
Aug 28, 2015
5855912*PED
Feb 28, 2015
5932247
Aug 28, 2015
5932247*PED
Mar 14, 2017
6037353
Sep 14, 2017
6037353*PED
Feb 28, 2015
6113942
Aug 28, 2015
6113942*PED
May 11, 2012
6187791
Nov 11, 2012
6187791*PED
May 11, 2012
6399632
Nov 11, 2012
6399632*PED
May 18, 2014
7135571
Nov 18, 2014
7135571*PED
May 18, 2014
7138524
Nov 18, 2014
7138524*PED

HIVES
DS DP

U-1160

DP
DP
U-1160
DP
U-1160
U-1160
DS

U-1160

DS

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES

N021909 003 5578610
Nov 26, 2013
DS DP
DP
5738872
Feb 28, 2015
6037353
Mar 14, 2017
6187791
May 11, 2012
May 11, 2012
6399632
May 18, 2014
DS
7138524

U-1158
U-1158
U-1158
U-1158

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 76 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES

N201373 002 5578610
Nov 26, 2013
DS DP
5578610*PED
May 26, 2014
6037353
Mar 14, 2017
6037353*PED
Sep 14, 2017
6187791
May 11, 2012
6187791*PED
Nov 11, 2012
6399632
May 11, 2012
6399632*PED
Nov 11, 2012
DS
7138524
May 18, 2014
7138524*PED
Nov 18, 2014

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1157
U-1157
U-1157
U-1157

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

N020786 002 5578610
Nov 26, 2013
DS DP U-1159
5578610*PED
May 26, 2014
5855912
Feb 28, 2015
DP
5855912*PED
Aug 28, 2015
U-1159
6037353
Mar 14, 2017
U-138
6037353*PED
Sep 14, 2017
6039974
Jul 31, 2018
DP
DP
6113942
Feb 28, 2015
6113942*PED
Aug 28, 2015
U-1159
6187791
May 11, 2012
U-138
6187791*PED
Nov 11, 2012
6399632
May 11, 2012
U-1159
U-468
6399632*PED
Nov 11, 2012
DS
U-1159
7135571
May 18, 2014
7135571*PED
Nov 18, 2014
DS
7138524
May 18, 2014
7138524*PED
Nov 18, 2014
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
N021704 002 5578610
Nov 26, 2013
DS DP U-1159
5578610*PED
May 26, 2014
U-1159
6037353
Mar 14, 2017
6037353*PED
Sep 14, 2017
U-1159
6187791
May 11, 2012
6187791*PED
Nov 11, 2012
U-1159
6399632
May 11, 2012
6399632*PED
Nov 11, 2012
DP U-1159
6613357
Dec 25, 2020
DS
7138524
May 18, 2014
7138524*PED
Nov 18, 2014
DP
RE39069
May 29, 2018
FIDAXOMICIN - DIFICID
N201699 001 7378508
7863249
7906489

Jul
Jul
Mar

31, 2027
31, 2027
04, 2027

FINASTERIDE - PROPECIA
N020788 001 5547957
5571817
5886184

Oct
Nov
Nov

15, 2013
05, 2013
19, 2012

FINASTERIDE - PROSCAR
N020180 001 5886184
5942519

Nov
Oct

19, 2012
23, 2018

DS

FINGOLIMOD - GILENYA
N022527 001 5604229

Feb

18, 2014

DS

FLUDARABINE PHOSPHATE - OFORTA

N022273 001 7148207
Dec
7547776
Dec

20, 2022
10, 2018

DS

FLUOCINOLONE ACETONIDE - RETISERT

N021737 001 6217895
Mar
6548078
Mar

22, 2019
22, 2019

DS
DS

DP
DP

NCE

May

27, 2016

U-1086

M-106
NCE

Jul
Sep

20, 2014
21, 2015

DP

U-944

NDF
ODE

Dec
Dec

18, 2011
18, 2015

DP
DP

U-708
U-708

ODE

Apr

08, 2012

U-319

U-236
U-259

U-280

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 77 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN - TRI-LUMA

DP
N021112 001 7915243
Mar 22, 2026
DP
7939516
May 04, 2025
FLUOCINONIDE - VANOS
N021758 001 6765001
7220424
7794738

Dec
Jan
Sep

21, 2021
07, 2023
11, 2022

DP

FLUOROURACIL - CARAC
N020985 001 6670335

Jun

02, 2021

DP

FLUOXETINE HYDROCHLORIDE - PROZAC

N018936 001 6960577
Nov

01, 2017

U-963

I-589

Mar

19, 2012

FLUOXETINE HYDROCHLORIDE - PROZAC

N018936 003 6960577
Nov

01, 2017

U-963

I-589

Mar

19, 2012

FLUOXETINE HYDROCHLORIDE - PROZAC

N018936 006 6960577
Nov

01, 2017

U-963

I-589

Mar

19, 2012

FLUOXETINE HYDROCHLORIDE - PROZAC WEEKLY

N021235 001 5910319
May 29, 2017
5985322
May 29, 2017
RE39030
May 29, 2017
RE39030
May 29, 2017

U-396
U-397
U-396
U-397

I-593

Mar

19, 2012

I-593

Mar

19, 2012

I-593

Mar

19, 2012

I-593

Mar

19, 2012

I-593

Mar

19, 2012

U-861
U-1084

DP
DP

FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX

N021520 001 5229382*PED
Oct 23, 2011
6960577
Nov 01, 2017
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N021520 002 5229382*PED
Oct 23, 2011
5945416
Mar 24, 2017
6960577
Nov 01, 2017
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N021520 003 5229382*PED
Oct 23, 2011
5945416
Mar 24, 2017
6960577
Nov 01, 2017
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N021520 004 5229382*PED
Oct 23, 2011
5945416
Mar 24, 2017
6960577
Nov 01, 2017
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N021520 005 5229382*PED
Oct 23, 2011
5945416
Mar 24, 2017
6960577
Nov 01, 2017
FLUTICASONE FUROATE - VERAMYST
N022051 001 6858596
Aug
7101866
Aug
7541350
Aug

03, 2021
03, 2021
03, 2021

FLUTICASONE PROPIONATE - CUTIVATE

N021152 001 7300669
Oct

20, 2019

FLUTICASONE PROPIONATE - FLOVENT DISKUS

N020833 002 5590645*PED
Sep 01,
5860419*PED
Sep 01,
5873360
Feb 23,
5873360*PED
Aug 23,
Sep 01,
6032666*PED
Sep 01,
6378519*PED
Sep 01,
6536427*PED
Sep 01,
6792945*PED
Sep 01,
7225808*PED
Sep 01,
7389775*PED

100
2011
2011
2016
2016
2011
2011
2011
2011
2011
2011

U-68

U-962

DS

DP

Y
U-962

DS

DP

Y
U-962

DS

DP

Y
U-962

DS

DP

Y
U-962

DS

DP
DP
DP

U-808
U-808
U-988

DP

U-835

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 78 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

FLUTICASONE PROPIONATE - FLOVENT DISKUS

N020833 003 5590645*PED
Sep 01,
5860419*PED
Sep 01,
5873360
Feb 23,
5873360*PED
Aug 23,
6032666*PED
Sep 01,
6378519*PED
Sep 01,
6536427*PED
Sep 01,
6792945*PED
Sep 01,
7225808*PED
Sep 01,
7389775*PED
Sep 01,

250
2011
2011
2016
2016
2011
2011
2011
2011
2011
2011

FLUTICASONE PROPIONATE - FLOVENT DISKUS

N020833 001 5590645*PED
Sep 01,
5860419*PED
Sep 01,
5873360
Feb 23,
5873360*PED
Aug 23,
6032666*PED
Sep 01,
6378519*PED
Sep 01,
6536427*PED
Sep 01,
6792945*PED
Sep 01,
7225808*PED
Sep 01,
7389775*PED
Sep 01,

50
2011
2011
2016
2016
2011
2011
2011
2011
2011
2011

FLUTICASONE PROPIONATE - FLOVENT HFA

N021433 001 5658549
Aug 19,
5658549*PED
Feb 19,
5674472
Oct 07,
5674472*PED
Apr 07,
6161724
Jan 16,
6161724*PED
Jul 16,
6170717
Dec 23,
6170717*PED
Jun 23,
6251368
Dec 04,
6251368*PED
Jun 04,
6315173
Dec 23,
6315173*PED
Jun 23,
6431168
Jun 08,
6431168*PED
Dec 08,
6435372
Jan 16,
6435372*PED
Jul 16,
6510969
Dec 23,
6510969*PED
Jun 23,
6596260
Aug 10,
6596260*PED
Feb 10,
6743413
Jun 01,
6743413*PED
Dec 01,
6938796
Jan 16,
6938796*PED
Jul 16,
6966467
Dec 23,
6966467*PED
Jun 23,
6997349
Jan 16,
6997349*PED
Jul 16,
7107986
Jun 08,
7107986*PED
Dec 08,
7143908
Jan 16,
7143908*PED
Jul 16,
7350676
Aug 24,
7350676*PED
Feb 24,
7500444
Jan 04,
7500444*PED
Jul 04,

2014
2015
2014
2015
2018
2018
2017
2018
2012
2013
2017
2018
2018
2018
2018
2018
2017
2018
2014
2015
2021
2021
2018
2018
2017
2018
2018
2018
2018
2019
2018
2018
2018
2019
2025
2025

PATENT
CODES

DP

DP

DP

U-710

DP
DP
DP
DP
DP
DP
DP
DP
DP
U-581
DP
DP
DP
DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 79 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

FLUTICASONE PROPIONATE - FLOVENT HFA

Aug 19,
N021433 002 5658549
Feb 19,
5658549*PED
Oct 07,
5674472
Apr 07,
5674472*PED
Jan 16,
6161724
Jul 16,
6161724*PED
Dec 23,
6170717
Jun 23,
6170717*PED
Dec 04,
6251368
Jun 04,
6251368*PED
Dec 23,
6315173
Jun 23,
6315173*PED
Jun 08,
6431168
Dec 08,
6431168*PED
Jan 16,
6435372
Jul 16,
6435372*PED
Dec 23,
6510969
Jun 23,
6510969*PED
Aug 10,
6596260
Feb 10,
6596260*PED
Jun 01,
6743413
Dec 01,
6743413*PED
Jan 16,
6938796
Jul 16,
6938796*PED
Dec 23,
6966467
Jun 23,
6966467*PED
Jan 16,
6997349
Jul 16,
6997349*PED
Jun 08,
7107986
Dec 08,
7107986*PED
Jan 16,
7143908
Jul 16,
7143908*PED
Aug 24,
7350676
Feb 24,
7350676*PED
Jan 04,
7500444
Jul 04,
7500444*PED

2014
2015
2014
2015
2018
2018
2017
2018
2012
2013
2017
2018
2018
2018
2018
2018
2017
2018
2014
2015
2021
2021
2018
2018
2017
2018
2018
2018
2018
2019
2018
2018
2018
2019
2025
2025

PATENT
CODES
DP

U-710

DP
DP
DP
DP
DP
DP
DP
DP
DP
U-581
DP
DP
DP
DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 80 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

FLUTICASONE PROPIONATE - FLOVENT HFA

N021433 003 5658549
Aug 19,
Feb 19,
5658549*PED
Oct 07,
5674472
Apr 07,
5674472*PED
Jan 16,
6161724
Jul 16,
6161724*PED
Dec 23,
6170717
Jun 23,
6170717*PED
Dec 04,
6251368
Jun 04,
6251368*PED
Dec 23,
6315173
Jun 23,
6315173*PED
Jun 08,
6431168
Dec 08,
6431168*PED
Jan 16,
6435372
Jul 16,
6435372*PED
Dec 23,
6510969
Jun 23,
6510969*PED
Aug 10,
6596260
Feb 10,
6596260*PED
Jun 01,
6743413
Dec 01,
6743413*PED
Jan 16,
6938796
Jul 16,
6938796*PED
Dec 23,
6966467
Jun 23,
6966467*PED
Jan 16,
6997349
Jul 16,
6997349*PED
Jun 08,
7107986
Dec 08,
7107986*PED
Jan 16,
7143908
Jul 16,
7143908*PED
Aug 24,
7350676
Feb 24,
7350676*PED
Jan 04,
7500444
Jul 04,
7500444*PED

2014
2015
2014
2015
2018
2018
2017
2018
2012
2013
2017
2018
2018
2018
2018
2018
2017
2018
2014
2015
2021
2021
2018
2018
2017
2018
2018
2018
2018
2019
2018
2018
2018
2019
2025
2025

PATENT
CODES
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-710
U-710

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
U-581
U-581
DP
DP
DP
DP
DP
DP
DP

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 100/50

N021077 001 5590645*PED
Sep 01, 2011
5860419*PED
Sep 01, 2011
DP
5873360
Feb 23, 2016
5873360*PED
Aug 23, 2016
6032666*PED
Sep 01, 2011
6378519*PED
Sep 01, 2011
6536427*PED
Sep 01, 2011
6792945*PED
Sep 01, 2011
7225808*PED
Sep 01, 2011
7389775*PED
Sep 01, 2011
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 250/50
N021077 002 5590645*PED
Sep 01, 2011
5860419*PED
Sep 01, 2011
DP
5873360
Feb 23, 2016
5873360*PED
Aug 23, 2016
6032666*PED
Sep 01, 2011
6378519*PED
Sep 01, 2011
6536427*PED
Sep 01, 2011
6792945*PED
Sep 01, 2011
7225808*PED
Sep 01, 2011
7389775*PED
Sep 01, 2011

M-84

Mar

31, 2012

M-84

Mar

31, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 81 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 500/50

N021077 003 5590645*PED
Sep 01, 2011
5860419*PED
Sep 01, 2011
DP
5873360
Feb 23, 2016
5873360*PED
Aug 23, 2016
6032666*PED
Sep 01, 2011
6378519*PED
Sep 01, 2011
6536427*PED
Sep 01, 2011
6792945*PED
Sep 01, 2011
7225808*PED
Sep 01, 2011
7389775*PED
Sep 01, 2011
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA
N021254 001 5658549
Aug 19, 2014
DP U-738
U-738
5658549*PED
Feb 19, 2015
5674472
Oct 07, 2014
DP
5674472*PED
Apr 07, 2015
DP
6161724
Jan 16, 2018
6161724*PED
Jul 16, 2018
DP
6170717
Dec 23, 2017
6170717*PED
Jun 23, 2018
DP
6251368
Dec 04, 2012
6251368*PED
Jun 04, 2013
DP
6315173
Dec 23, 2017
6315173*PED
Jun 23, 2018
DP
6431168
Jun 08, 2018
6431168*PED
Dec 08, 2018
DP
6435372
Jan 16, 2018
6435372*PED
Jul 16, 2018
6510969
Dec 23, 2017
6510969*PED
Jun 23, 2018
DP
6596260
Aug 10, 2014
6596260*PED
Feb 10, 2015
U-841
6743413
Jun 01, 2021
U-841
6743413*PED
Dec 01, 2021
DP
6938796
Jan 16, 2018
6938796*PED
Jul 16, 2018
DP
6966467
Dec 23, 2017
6966467*PED
Jun 23, 2018
DP
6997349
Jan 16, 2018
6997349*PED
Jul 16, 2018
DP
7107986
Jun 08, 2018
7107986*PED
Dec 08, 2018
DP
7143908
Jan 16, 2018
7143908*PED
Jul 16, 2018
DP
7350676
Aug 24, 2018
7350676*PED
Feb 24, 2019
DP
7500444
Jan 04, 2025
7500444*PED
Jul 04, 2025

EXCLUSIVITY
CODE(S)
M-84

EXCLUSIVITY
EXPIRATION
DATE

Mar

31, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 82 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA

Aug 19, 2014
DP U-738
N021254 002 5658549
Feb 19, 2015
DP U-738
5658549*PED
DP
Oct 07, 2014
5674472
DP
Apr 07, 2015
5674472*PED
Jan 16, 2018
DP
6161724
Jul 16, 2018
6161724*PED
DP
Dec 23, 2017
6170717
Jun 23, 2018
6170717*PED
DP
Dec 04, 2012
6251368
DP
Jun 04, 2013
6251368*PED
DP
Dec 23, 2017
6315173
DP
Jun 23, 2018
6315173*PED
DP
Jun 08, 2018
6431168
Dec 08, 2018
6431168*PED
DP
Jan 16, 2018
6435372
Jul 16, 2018
6435372*PED
DP
Dec 23, 2017
6510969
DP
Jun 23, 2018
6510969*PED
DP
Aug 10, 2014
6596260
Feb 10, 2015
6596260*PED
U-841
Jun 01, 2021
6743413
U-841
Dec 01, 2021
6743413*PED
DP
Jan 16, 2018
6938796
Jul 16, 2018
6938796*PED
DP
Dec 23, 2017
6966467
Jun 23, 2018
6966467*PED
DP
Jan 16, 2018
6997349
Jul 16, 2018
6997349*PED
DP
Jun 08, 2018
7107986
Dec 08, 2018
7107986*PED
DP
Jan 16, 2018
7143908
Jul 16, 2018
7143908*PED
DP
Aug 24, 2018
7350676
Feb 24, 2019
7350676*PED
DP
Jan 04, 2025
7500444
Jul 04, 2025
7500444*PED

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 83 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA

Aug 19, 2014
DP U-738
N021254 003 5658549
Feb 19, 2015
DP U-738
5658549*PED
DP
Oct 07, 2014
5674472
DP
Apr 07, 2015
5674472*PED
Jan 16, 2018
DP
6161724
Jul 16, 2018
6161724*PED
DP
Dec 23, 2017
6170717
Jun 23, 2018
6170717*PED
DP
Dec 04, 2012
6251368
DP
Jun 04, 2013
6251368*PED
DP
Dec 23, 2017
6315173
DP
Jun 23, 2018
6315173*PED
DP
Jun 08, 2018
6431168
Dec 08, 2018
6431168*PED
DP
Jan 16, 2018
6435372
Jul 16, 2018
6435372*PED
DP
Dec 23, 2017
6510969
DP
Jun 23, 2018
6510969*PED
DP
Aug 10, 2014
6596260
Feb 10, 2015
6596260*PED
U-841
Jun 01, 2021
6743413
U-841
Dec 01, 2021
6743413*PED
DP
Jan 16, 2018
6938796
Jul 16, 2018
6938796*PED
DP
Dec 23, 2017
6966467
Jun 23, 2018
6966467*PED
DP
Jan 16, 2018
6997349
Jul 16, 2018
6997349*PED
DP
Jun 08, 2018
7107986
Dec 08, 2018
7107986*PED
DP
Jan 16, 2018
7143908
Jul 16, 2018
7143908*PED
DP
Aug 24, 2018
7350676
Feb 24, 2019
7350676*PED
DP
Jan 04, 2025
7500444
Jul 04, 2025
7500444*PED
FLUVASTATIN SODIUM - LESCOL
N020261 001 5354772
5354772
5354772*PED
5356896
5356896*PED

Oct
Oct
Apr
Dec
Jun

11,
11,
11,
12,
12,

2011
2011
2012
2011
2012

U-109
U-413

FLUVASTATIN SODIUM - LESCOL

N020261 002 5354772
5354772
5354772*PED
5356896
5356896*PED

Oct
Oct
Apr
Dec
Jun

11,
11,
11,
12,
12,

2011
2011
2012
2011
2012

U-109
U-413

FLUVASTATIN SODIUM - LESCOL XL

N021192 001 5354772
Oct
5354772
Oct
5354772*PED
Apr
Dec
5356896
Jun
5356896*PED
Apr
6242003
Oct
6242003*PED

11,
11,
11,
12,
12,
13,
13,

2011
2011
2012
2011
2012
2020
2020

U-413
U-109

FLUVOXAMINE MALEATE - LUVOX CR

N022033 001 7465462
May

10, 2020

DP

U-929

FLUVOXAMINE MALEATE - LUVOX CR

May
N022033 002 7465462

10, 2020

DP

U-929

FOLLITROPIN ALFA/BETA - FOLLISTIM

N020582 001 5767251
Jun

16, 2015

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 84 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

FOLLITROPIN ALFA/BETA - FOLLISTIM

N020582 002 5767251
Jun

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

16, 2015

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N021211 001 5767251
Jun 16,
5929028
Jan 14,
7446090
Aug 23,
7563763
Aug 23,
7563763
Aug 23,

2015
2018
2019
2019
2019

DS

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N021211 002 5767251
Jun 16,
5929028
Jan 14,
7446090
Aug 23,
7563763
Aug 23,
7563763
Aug 23,

2015
2018
2019
2019
2019

DS

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N021211 003 5767251
Jun 16,
5929028
Jan 14,
7446090
Aug 23,
7563763
Aug 23,
7563763
Aug 23,

2015
2018
2019
2019
2019

DS

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N021211 004 5767251
Jun 16,
5929028
Jan 14,
7446090
Aug 23,
7563763
Aug 23,
7563763
Aug 23,

2015
2018
2019
2019
2019

DS

D-133
I-306

Aug
Jun

22, 2014
28, 2013

D-133
I-306

Aug
Jun

22, 2014
28, 2013

D-133

Aug

22, 2014

D-133
I-306

Aug
Jun

22, 2014
28, 2013

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N021273 001

I-306

Jun

28, 2013

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ

N021273 002

I-306

Jun

28, 2013

DP
DP

U-1183
U-993

DP
DP

DP
DP

DP
DP

U-567
U-993
U-1183

DS

FOLLITROPIN ALFA/BETA - GONAL-F

N020378 002 5767251
Jun

16, 2015

DS

FOLLITROPIN ALFA/BETA - GONAL-F

N020378 003 5767251
Jun

16, 2015

DS

FOLLITROPIN ALFA/BETA - GONAL-F

N020378 004 5767067
Jun
5767251
Jun
7563763
Aug

16, 2015
16, 2015
23, 2019

DS
DS

FOLLITROPIN ALFA/BETA - GONAL-F

N020378 005 5767067
Jun
5767251
Jun
7563763
Aug

16, 2015
16, 2015
23, 2019

DS
DS

FOLLITROPIN ALFA/BETA - GONAL-F

N021765 001 5767251
Jun

16, 2015

DS

FOLLITROPIN ALFA/BETA - GONAL-F

N021765 003 5767251
Jun

16, 2015

DS

FOLLITROPIN ALFA/BETA - GONAL-F RFF

N021765 002 5767067
Jun 16, 2015
5767251
Jun 16, 2015

DS
DS

2015
2015
2019
2024

U-567
U-1183
U-993

16, 2015

PEN
16,
16,
23,
02,

U-567
U-1183
U-993

FOLLITROPIN ALFA/BETA - GONAL-F

N020378 001 5767251
Jun

FOLLITROPIN ALFA/BETA - GONAL-F RFF

N021684 001 5767067
Jun
5767251
Jun
7446090
Aug
7741268
Apr

U-567

DP

DP

DS
DS
DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 85 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

FOLLITROPIN ALFA/BETA - GONAL-F RFF

N021684 002 5767067
Jun
5767251
Jun
7446090
Aug
7741268
Apr

PEN
16,
16,
23,
02,

2015
2015
2019
2024

DS
DS

FOLLITROPIN ALFA/BETA - GONAL-F RFF

N021684 003 5767067
Jun
5767251
Jun
7446090
Aug
7741268
Apr

PEN
16,
16,
23,
02,

2015
2015
2019
2024

DS
DS

FOMEPIZOLE - ANTIZOL
N020696 001 7553863

30, 2027

DS

Jun

DP

FORMOTEROL FUMARATE - FORADIL

N020831 001 6488027
6887459

U-762

08, 2019
28, 2020

22,
22,
22,
22,

DP
DP
DP
DP

2021
2021
2021
2021

FORMOTEROL FUMARATE; MOMETASONE FUROATE

N022518 001 5889015
Jan 27,
5889015*PED
Jul 27,
6057307
Jan 27,
6057307*PED
Jul 27,
6068832
Aug 27,
Jan 27,
6677323
May 21,
7067502
May 08,
7566705

- DULERA
2014
2014
2014
2014
2017
2014
2020
2020

FORMOTEROL FUMARATE; MOMETASONE FUROATE

N022518 002 5889015
Jan 27,
5889015*PED
Jul 27,
6057307
Jan 27,
6057307*PED
Jul 27,
6068832
Aug 27,
Jan 27,
6677323
May 21,
7067502
May 08,
7566705

- DULERA
2014
2014
2014
2014
2017
2014
2020
2020

FOSAMPRENAVIR CALCIUM - LEXIVA

N021548 001 6436989
6436989*PED
6514953
6514953*PED

2017
2018
2019
2020

FOSAMPRENAVIR CALCIUM - LEXIVA

N022116 001 6436989
Dec
6436989*PED
Jun

24, 2017
24, 2018

FOSAPREPITANT DIMEGLUMINE - EMEND

N022023 001 5512570
Mar
5538982
Jul
5691336
Mar
5716942
Feb
7214692
Sep

04,
23,
04,
10,
18,

2014
2013
2019
2015
2012

DS

FOSAPREPITANT DIMEGLUMINE - EMEND

N022023 002 5691336
Mar

04, 2019

DS

Dec
Jun
Jul
Jan

24,
24,
15,
15,

EXCLUSIVITY
EXPIRATION
DATE

DP
DP

U-522

FORMOTEROL FUMARATE - PERFOROMIST

N022007 001 6667344
Jun
6814953
Jun
7348362
Jun
7462645
Jun

EXCLUSIVITY
CODE(S)

DP
DP

FOMIVIRSEN SODIUM - VITRAVENE PRESERVATIVE FREE

N020961 001 5442049
Aug 15, 2012
5595978
Aug 15, 2012

Mar
Nov

PATENT
DELIST
REQUESTED

U-813
U-813

U-1068
DP

U-1068

DP

U-1068
U-1068
U-1068
U-1068

DP
DP

U-1068
DP

U-1068

DP
DP
DP

U-1068
U-1068
U-1068
U-1068

DS

DP

U-257

DS

DP

U-257

DS

DP

U-257

U-850
U-850

NC

Jun

22, 2013

NC

Jun

22, 2013

NCE

Jan

25, 2013

D-128
NCE

Nov
Jan

12, 2013
25, 2013

DP
U-850
U-850

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 86 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

FOSPROPOFOL DISODIUM - LUSEDRA

N022244 001 6204257
Aug
Aug
6872838

07, 2018
07, 2018

FROVATRIPTAN SUCCINATE - FROVA

N021006 001 5464864
Nov
5616603
Apr
5637611
Jun
5827871
Oct
5962501
Dec

07,
01,
10,
27,
16,

2015
2014
2014
2015
2013

U-436
U-436
U-436
U-436
U-436

FULVESTRANT - FASLODEX
N021344 001 6774122
6774122*PED
7456160
7456160*PED

09,
09,
09,
09,

2021
2021
2021
2021

U-596

Jan
Jul
Jan
Jul

DS
DS

DP

U-945

U-596

GABAPENTIN - GABAPENTIN
A078974 001
GABAPENTIN - GRALISE
N022544 001 6340475
6488962
6635280
6723340
7438927
7731989

Sep
Jun
Sep
Oct
Feb
Oct

19,
20,
19,
25,
26,
25,

2016
2020
2016
2021
2024
2022

DP
DP
DP
DP

GABAPENTIN - GRALISE
N022544 002 6340475
6488962
6635280
6723340
7438927
7731989

Sep
Jun
Sep
Oct
Feb
Oct

19,
20,
19,
25,
26,
25,

2016
2020
2016
2021
2024
2022

DP
DP
DP
DP

GABAPENTIN - NEURONTIN
N020235 001 6054482
6054482*PED

Apr
Oct

25, 2017
25, 2017

GABAPENTIN - NEURONTIN
N020235 002 6054482
6054482*PED

Apr
Oct

25, 2017
25, 2017

GABAPENTIN - NEURONTIN
N020235 003 6054482
6054482*PED

Apr
Oct

25, 2017
25, 2017

GABAPENTIN - NEURONTIN
N020882 001 6054482
6054482*PED

Apr
Oct

25, 2017
25, 2017

GABAPENTIN - NEURONTIN
N020882 002 6054482
6054482*PED

Apr
Oct

25, 2017
25, 2017

GABAPENTIN - NEURONTIN
N021129 001 6054482
6054482*PED
7256216
7256216*PED

Apr
Oct
May
Nov

25,
25,
28,
28,

GABAPENTIN ENACARBIL - HORIZANT

N022399 001 6818787
Nov
8026279
Nov
8048917
Nov

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Dec

12, 2013

D-126
M-103
PED
PED

Sep
May
Nov
Mar

09,
17,
17,
09,

PC

Aug

22, 2011

NP

Jan

28, 2014

NP

Jan

28, 2014

NCE

Apr

06, 2016

2013
2014
2014
2014

U-1114
DP

U-1114
DP

2017
2017
2022
2022

06, 2022
10, 2026
06, 2022

PATENT
DELIST
REQUESTED

DP

DS
DS
DS

DP
DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 87 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

GABAPENTIN ENACARBIL - HORIZANT

N022399 002 6818787
Nov
8026279
Nov
8048917
Nov

PATENT
CODES

06, 2022
10, 2026
06, 2022

DS
DS
DS

GADOBENATE DIMEGLUMINE - MULTIHANCE

N021357 001 4916246
Apr 10, 2012
GADOBENATE DIMEGLUMINE - MULTIHANCE
Apr 10, 2012
N021357 002 4916246

DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Apr

06, 2016

DS

NPP

Mar

17, 2013

DS

NPP

Mar

17, 2013

GADOBENATE DIMEGLUMINE - MULTIHANCE

N021357 003 4916246
Apr 10, 2012

DS

NPP

Mar

17, 2013

GADOBENATE DIMEGLUMINE - MULTIHANCE

Apr 10, 2012
N021357 004 4916246

DS

NPP

Mar

17, 2013

GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK

Apr 10, 2012
N021358 001 4916246

DS

GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK

N021358 002 4916246
Apr 10, 2012

DS

GADOBUTROL - GADAVIST
N201277 001 5980864

Nov

09, 2016

DS

DP

U-1119

NCE

Mar

14, 2016

GADOBUTROL - GADAVIST
N201277 002 5980864

Nov

09, 2016

DS

DP

U-1119

NCE

Mar

14, 2016

GADOBUTROL - GADAVIST
N201277 003 5980864

Nov

09, 2016

DS

DP

U-1119

NCE

Mar

14, 2016

GADOBUTROL - GADAVIST
N201277 004 5980864

Nov

09, 2016

DS

DP

U-1119

NCE

Mar

14, 2016

GADOBUTROL - GADAVIST
N201277 005 5980864

Nov

09, 2016

DS

DP

U-1119

NCE

Mar

14, 2016

GADODIAMIDE - OMNISCAN
N020123 001 5362475
5560903

Nov
Oct

08, 2011
01, 2013

DS

GADODIAMIDE - OMNISCAN
N022066 001 5560903

Oct

01, 2013

GADODIAMIDE - OMNISCAN
N022066 002 5362475
5560903

Nov
Oct

08, 2011
01, 2013

DS

GADOFOSVESET TRISODIUM - ABLAVAR

N021711 001 5362475
Nov
6676929
May
Feb
7011815
May
7060250
May
7229606
May
8017105

08,
26,
01,
26,
26,
26,

2011
2015
2015
2015
2015
2015

DS

NCE

Dec

22, 2013

GADOFOSVESET TRISODIUM - ABLAVAR

Nov
N021711 002 5362475
May
6676929
Feb
7011815
May
7060250
May
7229606
May
8017105

08,
26,
01,
26,
26,
26,

2011
2015
2015
2015
2015
2015

DS

NCE

Dec

22, 2013

GADOPENTETATE DIMEGLUMINE - MAGNEVIST

N019596 001 5362475
Nov 08, 2011
GADOPENTETATE DIMEGLUMINE - MAGNEVIST
N021037 001 5362475
Nov 08, 2011

DP

DP

DP

DP
U-1112
DS
U-1112
DS

DP
U-1112
DS
U-1112
DS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 88 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

GADOTERIDOL - PROHANCE
N020131 001 5474756
5846519
6143274

PATENT
EXPIRATION
DATE

PATENT
CODES

Dec
Dec
Dec

12, 2012
08, 2015
12, 2012

U-480

GADOTERIDOL - PROHANCE MULTIPACK

N021489 001 5474756
Dec
5846519
Dec
6143274
Dec

12, 2012
08, 2015
12, 2012

U-536

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-480

U-536

GADOXETATE DISODIUM - EOVIST

N022090 001

NCE

Jul

03, 2013

NDF
ODE

Sep
Sep

15, 2012
15, 2016

NP

May

18, 2013

GEMCITABINE HYDROCHLORIDE - GEMCITABINE HYDROCHLORIDE

A077983 001

PC

Jul

24, 2011

GEMCITABINE HYDROCHLORIDE - GEMCITABINE HYDROCHLORIDE

A077983 002

PC

Jul

24, 2011

GALANTAMINE HYDROBROMIDE - RAZADYNE

N021169 001 6099863
Jun 06, 2017
6358527
Jun 06, 2017

DP

U-322

GALANTAMINE HYDROBROMIDE - RAZADYNE

N021169 002 6099863
Jun 06, 2017
6358527
Jun 06, 2017

DP

U-322

GALANTAMINE HYDROBROMIDE - RAZADYNE

N021169 003 6099863
Jun 06, 2017
6358527
Jun 06, 2017

DP

U-322

GALANTAMINE HYDROBROMIDE - RAZADYNE ER

N021615 001 7160559
Dec 20, 2019

DP

GALANTAMINE HYDROBROMIDE - RAZADYNE ER

N021615 002 7160559
Dec 20, 2019

DP

GALANTAMINE HYDROBROMIDE - RAZADYNE ER

N021615 003 7160559
Dec 20, 2019

DP

GANCICLOVIR - VITRASERT
N020569 001 5378475

Jan

03, 2012

GANCICLOVIR - ZIRGAN
N022211 001
GANIRELIX ACETATE - GANIRELIX ACETATE INJECTION
DS
N021057 001 4801577
Feb 05, 2012
5767082
Jun 16, 2015
GATIFLOXACIN - ZYMAR
N021493 001 5880283
5880283*PED
6333045
6333045*PED

Dec
Jun
Aug
Feb

05,
05,
20,
20,

2015
2016
2019
2020

GATIFLOXACIN - ZYMAXID
N022548 001 5880283
5880283*PED
6333045
6333045*PED

Dec
Jun
Aug
Feb

05,
05,
20,
20,

2015
2016
2019
2020

GEFITINIB - IRESSA
N021399 001 5457105
5616582
5770599

Jan
Jan
May

19, 2013
19, 2013
05, 2017

GEMCITABINE HYDROCHLORIDE - GEMZAR

Nov
N020509 001 5464826
May
5464826*PED

07, 2012
07, 2013

DP

DP

DS
DS

DP

DS

DP

U-881

U-146

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 89 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

GEMCITABINE HYDROCHLORIDE - GEMZAR

N020509 002 5464826
Nov
5464826*PED
May

07, 2012
07, 2013

GEMIFLOXACIN MESYLATE - FACTIVE

N021158 001 5633262
Jun
5776944
Apr
Jun
5962468
Sep
6262071
Sep
6331550
Sep
6340689
Sep
6455540
Mar
6723734
Sep
6803376
Sep
6803376

15,
04,
15,
21,
21,
14,
21,
20,
21,
21,

2015
2017
2015
2019
2019
2019
2019
2018
2019
2019

GEMTUZUMAB OZOGAMICIN - MYLOTARG

Dec
N021174 001 5585089
Feb
5606040
Dec
5693762
Apr
5739116
Jun
5767285
Jun
5773001

17,
25,
02,
14,
16,
30,

2013
2014
2014
2015
2015
2015

GLATIRAMER ACETATE - COPAXONE

N020622 001 5981589
6054430
6342476
6362161
6620847
6939539
7199098

May
May
May
May
May
May
May

24,
24,
24,
24,
24,
24,
24,

2014
2014
2014
2014
2014
2014
2014

GLATIRAMER ACETATE - COPAXONE

N020622 002 5981589
6054430
6342476
6362161
6620847
6939539
7199098

May
May
May
May
May
May
May

24,
24,
24,
24,
24,
24,
24,

2014
2014
2014
2014
2014
2014
2014

PATENT
CODES

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-146

DS

DP
U-282
U-513
U-511
U-512
U-511

DS
DS
DS

DP
DP
DP

U-608
U-609

U-320

I-594

Feb

27, 2012

I-594

Feb

27, 2012

U-441
U-441
DS
DS
DS

U-441
U-441
DS
DS
DS

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT

N021925 001 6150383
Jun 19, 2016
6211205
Jun 19, 2016
6303640
Aug 09, 2016
Jun 19, 2016
6329404
Jun 19, 2016
7538125
Jan 30, 2027
7700128
Jun 08, 2028
8071130
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT
N021925 002 6150383
Jun 19, 2016
6211205
Jun 19, 2016
6303640
Aug 09, 2016
Jun 19, 2016
6329404
Jun 19, 2016
7538125
Jan 30, 2027
7700128
Jun 08, 2028
8071130
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N021700 001 5002953
Sep 17, 2011
Sep 17, 2011
5002953
Mar 17, 2012
5002953*PED
Apr 21, 2015
5741803
Apr 21, 2015
5741803
Oct 21, 2015
5741803*PED
Apr 19, 2020
7358366
Oct 19, 2020
7358366*PED

PATENT
DELIST
REQUESTED

DP
DP
DP
DP

DP
DP
DP
DP

DS
DS

DP
DP

DS
DS

DP
DP

DS

U-753
U-753
U-753
U-753

U-753
U-753
U-753
U-753

U-690
U-781
U-781
U-781
U-690

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 90 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL

N021700 002 5002953
Sep 17, 2011
Sep 17, 2011
5002953
Mar 17, 2012
5002953*PED
Apr 21, 2015
5741803
Apr 21, 2015
5741803
Oct 21, 2015
5741803*PED
Apr 19, 2020
7358366
Oct 19, 2020
7358366*PED
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N021700 003 5002953
Sep 17, 2011
Sep 17, 2011
5002953
Mar 17, 2012
5002953*PED
Apr 21, 2015
5741803
Apr 21, 2015
5741803
Oct 21, 2015
5741803*PED
Apr 19, 2020
7358366
Oct 19, 2020
7358366*PED
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N021700 004 5002953
Sep 17, 2011
Mar 17, 2012
5002953*PED
Apr 19, 2020
7358366
Oct 19, 2020
7358366*PED
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N021700 005 5002953
Sep 17, 2011
5002953*PED
Mar 17, 2012
7358366
Apr 19, 2020
7358366*PED
Oct 19, 2020

PATENT
CODES
DS
DS

DP
DP

U-690
U-781

DS
DS

DP
DP

U-690
U-781

DS
DS

DP
DP

U-690
U-781

DS
DS

DP
DP

U-690
U-781

DP

U-840

DP

U-840

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS

DS

DS
DS

DS
DS

GLIPIZIDE - GLUCOTROL XL
N020329 001 5591454

Jan

07, 2014

U-150

GLIPIZIDE - GLUCOTROL XL
N020329 002 5591454

Jan

07, 2014

U-150

GLIPIZIDE - GLUCOTROL XL
N020329 003 5591454

Jan

07, 2014

U-111

GLUTAMINE - NUTRESTORE
N021667 001 5288703

Oct

07, 2011

U-898

GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE

N021178 001 6303146
Jul 14, 2019
6303146*PED
Jan 14, 2020

U-412
U-412

GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE

N021178 002 6303146
Jul 14, 2019
6303146*PED
Jan 14, 2020

U-412
U-412

GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE

N021178 003 6303146
Jul 14, 2019
6303146*PED
Jan 14, 2020

U-412
U-412

GLYCOPYRROLATE - CUVPOSA
N022571 001 7638552
7816396

Aug
Aug

20, 2023
20, 2023

U-1076
U-1076

GLYCOPYRROLATE - ROBINUL
N012827 001 7091236

Apr

24, 2024

U-877

GLYCOPYRROLATE - ROBINUL FORTE

N012827 002 7091236
Apr

24, 2024

U-877

GOSERELIN ACETATE - ZOLADEX

N019726 001 7118552
7220247
7500964

13, 2022
09, 2022
26, 2021

Apr
Apr
Feb

PATENT
DELIST
REQUESTED

DP
DP
DP

NP

Jul

28, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 91 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

GOSERELIN ACETATE - ZOLADEX

N020578 001 7118552
7220247
7500964

Apr
Apr
Feb

13, 2022
09, 2022
26, 2021

DP
DP
DP

GRANISETRON - SANCUSO
N022198 001 7608282

Oct

22, 2024

DP

GRANISETRON HYDROCHLORIDE - KYTRIL

N020239 001 5952340
Sep
6294548
May
GRANISETRON HYDROCHLORIDE - KYTRIL
N020239 002 5952340
Sep
6294548
May

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-1011

NE
NDF

Sep
Sep

12, 2011
12, 2011

14, 2016
04, 2019

U-519

M-102

Apr

29, 2014

14, 2016
04, 2019

U-519

M-102

Apr

29, 2014

M-102

Apr

29, 2014

M-102

Apr

29, 2014

I-635
NP

Feb
Sep

25, 2014
02, 2012

I-635
NP

Feb
Sep

25, 2014
02, 2012

I-635
NP

Feb
Sep

25, 2014
02, 2012

I-635
NP

Feb
Sep

25, 2014
02, 2012

GRANISETRON HYDROCHLORIDE - KYTRIL

N020239 003
GRANISETRON HYDROCHLORIDE - KYTRIL
N020239 004 5952340
Sep
6294548
May

PATENT
DELIST
REQUESTED

14, 2016
04, 2019

U-519

GREPAFLOXACIN HYDROCHLORIDE - RAXAR

N020695 001 5563138
Oct 08, 2013
GUAIFENESIN - MUCINEX
N021282 001 6372252
6955821
7838032

Apr
Apr
Apr

28, 2020
28, 2020
28, 2020

DP
DP

GUAIFENESIN - MUCINEX
N021282 002 6372252
6955821
7838032

Apr
Apr
Apr

28, 2020
28, 2020
28, 2020

DP
DP

U-489
U-489

U-489
U-489

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D

N021585 001 6372252
Apr 28, 2020
DP
DP U-686
6955821
Apr 28, 2020
DP
7838032
Apr 28, 2020
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D
N021585 002 6372252
Apr 28, 2020
DP
DP U-686
6955821
Apr 28, 2020
DP
7838032
Apr 28, 2020
GUANFACINE HYDROCHLORIDE - INTUNIV
N022037 001 5854290
Sep
6287599
Dec
6811794
Jul

21, 2015
20, 2020
04, 2022

DP
DP

GUANFACINE HYDROCHLORIDE - INTUNIV

N022037 002 5854290
Sep
6287599
Dec
6811794
Jul

21, 2015
20, 2020
04, 2022

DP
DP

GUANFACINE HYDROCHLORIDE - INTUNIV

N022037 003 5854290
Sep
6287599
Dec
6811794
Jul

21, 2015
20, 2020
04, 2022

DP
DP

GUANFACINE HYDROCHLORIDE - INTUNIV

N022037 004 5854290
Sep
6287599
Dec
6811794
Jul

21, 2015
20, 2020
04, 2022

DP
DP

U-494
U-494

U-494
U-494

U-494
U-494

U-494
U-494

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 92 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

HEXAMINOLEVULINATE HYDROCHLORIDE - CYSVIEW KIT

N022555 001 6034267
Mar 08, 2016
7247655
Mar 08, 2016
7348361
Apr 22, 2019
7530461
Jan 11, 2017
HISTRELIN ACETATE - SUPPRELIN LA
N022058 001 8062652
Jun

DP
DP
DP

16, 2026

PATENT
DELIST
REQUESTED

NP

May

28, 2013

U-1197

ODE

May

03, 2014

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE - BIDIL

U-71
N020727 001 6465463
Sep 08, 2020
U-71
6784177
Sep 08, 2020
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N020758 001 5270317
Sep 30, 2011
5270317*PED
Mar 30, 2012
5994348
Jun 07, 2015
5994348*PED
Dec 07, 2015
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N020758 002 5270317
Sep 30, 2011
5270317*PED
Mar 30, 2012
5994348
Jun 07, 2015
5994348*PED
Dec 07, 2015
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N020758 003 5270317
Sep 30, 2011
5270317*PED
Mar 30, 2012
5994348
Jun 07, 2015
5994348*PED
Dec 07, 2015

DS

DP
DP

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT

DS DP U-500
N021532 002 5616599
Apr 25, 2016
5616599*PED
Oct 25, 2016
U-3
6878703
Nov 19, 2021
6878703*PED
May 19, 2022
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
DS DP U-500
N021532 003 5616599
Apr 25, 2016
5616599*PED
Oct 25, 2016
U-3
6878703
Nov 19, 2021
6878703*PED
May 19, 2022
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
DS DP U-500
N021532 005 5616599
Apr 25, 2016
5616599*PED
Oct 25, 2016
U-3
6878703
Nov 19, 2021
6878703*PED
May 19, 2022
HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT
DS
N021162 001 5591762
Jan 07, 2014
6358986
Jan 10, 2020

DP

U-3

HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT

DS
N021162 002 5591762
Jan 07, 2014
6358986
Jan 10, 2020

DP

U-3

DP

U-3

HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT

DS
N021162 003 5591762
Jan 07, 2014

EXCLUSIVITY
EXPIRATION
DATE

U-1087
U-1087
U-1087
U-1087

HYALURONIDASE RECOMBINANT HUMAN - HYLENEX RECOMBINANT

N021859 001 7767429
Sep 23, 2027
DS DP

HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE

N020758 004 5270317
Sep 30, 2011
5270317*PED
Mar 30, 2012
5994348
Jun 07, 2015
5994348*PED
Dec 07, 2015

EXCLUSIVITY
CODE(S)

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 93 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

HYDROCHLOROTHIAZIDE; VALSARTAN
N020818 001 5399578
5399578*PED
6294197
6294197*PED

- DIOVAN
Mar 21,
Sep 21,
Jun 18,
Dec 18,

HCT
2012
2012
2017
2017

HYDROCHLOROTHIAZIDE; VALSARTAN
N020818 002 5399578
5399578*PED
6294197
6294197*PED

- DIOVAN
Mar 21,
Sep 21,
Jun 18,
Dec 18,

HCT
2012
2012
2017
2017

HYDROCHLOROTHIAZIDE; VALSARTAN
N020818 003 5399578
5399578*PED
6294197
6294197*PED

- DIOVAN
Mar 21,
Sep 21,
Jun 18,
Dec 18,

HCT
2012
2012
2017
2017

HYDROCHLOROTHIAZIDE; VALSARTAN
N020818 004 5399578
5399578*PED
6294197
6294197*PED

- DIOVAN
Mar 21,
Sep 21,
Jun 18,
Dec 18,

HCT
2012
2012
2017
2017

HYDROCHLOROTHIAZIDE; VALSARTAN
N020818 005 5399578
5399578*PED
6294197
6294197*PED

- DIOVAN
Mar 21,
Sep 21,
Jun 18,
Dec 18,

HCT
2012
2012
2017
2017

PATENT
CODES
U-3

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-567

Jul

31, 2011

I-567

Jul

31, 2011

I-567

Jul

31, 2011

I-567

Jul

31, 2011

I-567

Jul

31, 2011

I-613

Oct

19, 2012

NDF

Mar

01, 2013

U-3

U-3
U-3

U-3
U-3

U-3
U-3

U-3
U-3

HYDROCODONE BITARTRATE; IBUPROFEN - VICOPROFEN

N020716 001 6348216
Jun 10, 2017
6599531
Jun 10, 2017
HYDROCORTISONE BUTYRATE - LOCOID
N022076 001 7378405
Dec
7981877
Jan

DP
DP

19, 2026
23, 2025

HYDROCORTISONE BUTYRATE - LOCOID LIPOCREAM

N020769 001 5635497
Jun 03, 2014
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N019034 003 6589960
Nov 09, 2020

DS

DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N019034 004 6589960
Nov 09, 2020

DS

DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N019034 005 6589960
Nov 09, 2020

DS

DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N019891 001 6589960
Nov 09, 2020

DS

DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N019892 001 6589960
Nov 09, 2020

DS

DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N019892 002 6589960
Nov 09, 2020

DS

DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N019892 003 6589960
Nov 09, 2020

DS

DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP

N019034 001 6589960
Nov 09, 2020

DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP

N019034 002 6589960
Nov 09, 2020

DP

HYDROMORPHONE HYDROCHLORIDE - EXALGO

N021217 001 5702725
Jul 07, 2014
5914131
Jul 07, 2014

DP
DP

U-1043
U-1043

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 94 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

HYDROMORPHONE HYDROCHLORIDE - EXALGO

N021217 002 5702725
Jul 07, 2014
5914131
Jul 07, 2014

DP
DP

U-1043
U-1043

NDF

Mar

01, 2013

HYDROMORPHONE HYDROCHLORIDE - EXALGO

N021217 003 5702725
Jul 07, 2014
5914131
Jul 07, 2014

DP
DP

U-1043
U-1043

NDF

Mar

01, 2013

HYDROMORPHONE HYDROCHLORIDE - PALLADONE

N021044 001 5958452
Nov 04, 2014
5965161
Nov 04, 2014
5968551
Dec 24, 2011
6294195
Dec 24, 2011
6335033
Nov 04, 2014
6589960
Nov 09, 2020
6706281
Nov 04, 2014
6743442
Nov 04, 2014

DP
DP
DP
DP
DP
DP
DP
DP

HYDROMORPHONE HYDROCHLORIDE - PALLADONE

N021044 002 5958452
Nov 04, 2014
5965161
Nov 04, 2014
5968551
Dec 24, 2011
6294195
Dec 24, 2011
6335033
Nov 04, 2014
6589960
Nov 09, 2020
6706281
Nov 04, 2014
6743442
Nov 04, 2014

DP
DP
DP
DP
DP
DP
DP
DP

HYDROMORPHONE HYDROCHLORIDE - PALLADONE

N021044 003 5958452
Nov 04, 2014
5965161
Nov 04, 2014
5968551
Dec 24, 2011
6294195
Dec 24, 2011
6335033
Nov 04, 2014
6589960
Nov 09, 2020
6706281
Nov 04, 2014
6743442
Nov 04, 2014

DP
DP
DP
DP
DP
DP
DP
DP

HYDROMORPHONE HYDROCHLORIDE - PALLADONE

N021044 004 5958452
Nov 04, 2014
5965161
Nov 04, 2014
5968551
Dec 24, 2011
6294195
Dec 24, 2011
6335033
Nov 04, 2014
6589960
Nov 09, 2020
6706281
Nov 04, 2014
6743442
Nov 04, 2014

DP
DP
DP
DP
DP
DP
DP
DP

HYDROXOCOBALAMIN - CYANOKIT
N022041 001 5834448

Nov

14, 2016

DP

ODE

Dec

15, 2013

HYDROXOCOBALAMIN - CYANOKIT
N022041 002 5834448

Nov

14, 2016

DP

ODE

Dec

15, 2013

ODE

Feb

03, 2018

U-616

U-616
U-616

U-616

U-616
U-616

U-616

U-616
U-616

U-616

U-616
U-616

U-789

HYDROXYPROGESTERONE CAPROATE - MAKENA

N021945 001
IBANDRONATE SODIUM - BONIVA
N021455 001 4927814
4927814
6143326
6294196

Mar
Mar
Apr
Oct

17,
17,
21,
07,

2012
2012
2017
2019

DS
DS

IBANDRONATE SODIUM - BONIVA

N021455 002 4927814
4927814
6294196
7192938
7410957
7718634

Mar
Mar
Oct
May
May
May

17,
17,
07,
06,
06,
06,

2012
2012
2019
2023
2023
2023

DS
DS

DP
DP

U-700
U-642
U-642

DP

DP
DP
DP

U-700
U-642
U-798
U-887
U-642

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 95 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

IBANDRONATE SODIUM - BONIVA

N021858 001 4927814
5662918

Mar
Sep

17, 2012
02, 2014

IBUPROFEN - CALDOLOR
N022348 001 6727286

Nov

IBUPROFEN - CALDOLOR
N022348 002 6727286

PATENT
CODES
DS

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP

U-700

27, 2021

DP

U-981

NP

Jun

11, 2012

Nov

27, 2021

DP

U-981

NP

Jun

11, 2012

IBUPROFEN - CHILDREN'S MOTRIN

N020516 001 5374659
5374659*PED

Dec
Jun

20, 2011
20, 2012

IBUPROFEN - CHILDREN'S MOTRIN

N020603 001 5374659
5374659*PED

Dec
Jun

20, 2011
20, 2012

IBUPROFEN - MIDOL LIQUID GELS

N021472 001 6251426

Jun

25, 2018

IBUPROFEN - MOTRIN
N019842 001 5374659
5374659*PED

Dec
Jun

20, 2011
20, 2012

IBUPROFEN - MOTRIN
N020135 001 5320855*PED

Dec

14, 2011

IBUPROFEN - MOTRIN
N020135 002 5320855*PED

Dec

14, 2011

IBUPROFEN LYSINE - NEOPROFEN

N021903 001 6342530
6342530
6344479

Nov
Nov
Mar

14, 2020
14, 2020
20, 2021

DP
DP
DP

U-794
U-1127
U-794

ODE

Apr

13, 2013

NCE
ODE

Aug
Aug

25, 2016
25, 2018

DS

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - CHILDREN'S MOTRIN COLD

N021128 001 6211246
Jun 10, 2019
ICATIBANT ACETATE - FIRAZYR
N022150 001 5648333

Jul

15, 2014

ICODEXTRIN - EXTRANEAL
N021321 001 6077836
6248726

Jun
Jun

20, 2017
19, 2018

ILOPERIDONE - FANAPT
N022192 001 RE39198

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

ILOPERIDONE - FANAPT
N022192 002 RE39198

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

ILOPERIDONE - FANAPT
N022192 003 RE39198

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

ILOPERIDONE - FANAPT
N022192 004 RE39198

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

ILOPERIDONE - FANAPT
N022192 005 RE39198

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

ILOPERIDONE - FANAPT
N022192 006 RE39198

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

ILOPERIDONE - FANAPT
N022192 007 RE39198

Nov

15, 2016

DS

DP

U-971

NCE

May

06, 2014

ODE

Dec

29, 2011

ILOPROST - VENTAVIS
N021779 001

DS

DP

U-1187

U-495
U-495

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 96 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ILOPROST - VENTAVIS
N021779 002

ODE

Dec

29, 2011

ILOPROST - VENTAVIS
N021779 003

ODE

Dec

29, 2011

I-583
ODE
ODE
ODE
ODE
ODE

Dec
Oct
Oct
Oct
Oct
Oct

19,
19,
19,
19,
19,
19,

2011
2013
2013
2013
2013
2013

I-583
ODE
ODE
ODE
ODE
ODE

Dec
Oct
Oct
Oct
Oct
Oct

19,
19,
19,
19,
19,
19,

2011
2013
2013
2013
2013
2013

I-636
NP

Mar
Mar

24, 2014
25, 2013

NS

Jul

15, 2014

NCE

Jul

01, 2016

IMATINIB MESYLATE - GLEEVEC

N021335 001 5521184
5521184*PED
6894051
6894051*PED
6958335
6958335*PED

Jan
Jul
May
Nov
Dec
Jun

04,
04,
23,
23,
19,
19,

2015
2015
2019
2019
2021
2022

DS

DP

DS

DP

IMATINIB MESYLATE - GLEEVEC

N021335 002 5521184
5521184*PED
6894051
6894051*PED
6958335
6958335*PED

Jan
Jul
May
Nov
Dec
Jun

04,
04,
23,
23,
19,
19,

2015
2015
2019
2019
2021
2022

DS

DP

U-649

DS

DP

U-649

IMATINIB MESYLATE - GLEEVEC

N021588 001 5521184
5521184*PED
6894051
6894051*PED
6958335
6958335*PED
7544799
7544799*PED

Jan
Jul
May
Nov
Dec
Jun
Jan
Jul

04,
04,
23,
23,
19,
19,
16,
16,

2015
2015
2019
2019
2021
2022
2019
2019

DS

DP

DS

DP

IMATINIB MESYLATE - GLEEVEC

N021588 002 5521184
5521184*PED
6894051
6894051*PED
6958335
6958335*PED
7544799
7544799*PED

Jan
Jul
May
Nov
Dec
Jun
Jan
Jul

04,
04,
23,
23,
19,
19,
16,
16,

2015
2015
2019
2019
2021
2022
2019
2019

IMIGLUCERASE - CEREZYME
N020367 001 5549892

Aug

27, 2013

U-252

IMIGLUCERASE - CEREZYME
N020367 002 5549892

Aug

27, 2013

U-252

IMIQUIMOD - ALDARA
N020723 001 7696159
7696159
7696159*PED

Apr
Apr
Oct

01, 2024
01, 2024
01, 2024

U-649
U-791

U-791

U-649
U-791

DS

DS

DP

DP

U-649
U-791

DS

DP

DS
DS

U-1048
U-1047

IMIQUIMOD - ZYCLARA
N022483 001
IMIQUIMOD - ZYCLARA
N022483 002
INDACATEROL MALEATE - ARCAPTA NEOHALER
N022383 001 6878721
Oct 10, 2020
INDINAVIR SULFATE - CRIXIVAN
N020685 001 5413999
6645961
6689761

May
Mar
Feb

09, 2012
04, 2018
10, 2021

DS

DP

U-1168

U-132
DP
U-554

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 97 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

INDINAVIR SULFATE - CRIXIVAN

N020685 003 5413999
6645961
6689761

May
Mar
Feb

09, 2012
04, 2018
10, 2021

DP

INDINAVIR SULFATE - CRIXIVAN

N020685 005 5413999
6645961
6689761

May
Mar
Feb

09, 2012
04, 2018
10, 2021

DP

INDINAVIR SULFATE - CRIXIVAN

N020685 006 5413999
6645961
6689761

May
Mar
Feb

09, 2012
04, 2018
10, 2021

DP

INDIUM IN-111 PENTETREOTIDE KIT - OCTREOSCAN

N020314 001 5384113
Jan 24, 2012
5753627
May 19, 2015
5776894
Jul 07, 2015

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-132
U-554

U-132
U-554

U-132
U-554

U-1125
DS

DP

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 50/50
DS DP
N021810 001 5547930
Sep 28, 2013
DS DP
5618913
Jun 07, 2014
5618913*PED
Dec 07, 2014
DP U-471
5834422
Sep 28, 2013
DS DP U-471
5840680
Sep 28, 2013
DP
5866538
Jun 20, 2017
5866538*PED
Dec 20, 2017
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30
DS DP
N021172 001 5547930
Sep 28, 2013
DS DP
5618913
Jun 07, 2014
5618913*PED
Dec 07, 2014
DP U-471
5834422
Sep 28, 2013
DS DP U-471
5840680
Sep 28, 2013
DP
5866538
Jun 19, 2017
INSULIN ASPART RECOMBINANT - NOVOLOG
N020986 001 5618913
Jun 07, 2014
5618913*PED
Dec 07, 2014
5866538
Jun 20, 2017
5866538*PED
Dec 20, 2017

DS

DP

U-668

U-948

INSULIN DETEMIR RECOMBINANT - LEVEMIR

N021536 001 5750497
May 16,
5866538
Jun 20,
6011007
Feb 02,
6869930
Feb 02,

2019
2017
2014
2014

DS
DS
DS

DP
DP
DP
DP

INSULIN GLARGINE RECOMBINANT - LANTUS

N021081 001 5656722
Aug 12,
5656722*PED
Feb 12,
7476652
Jul 23,
7476652*PED
Jan 23,
7713930
Jun 13,
7713930*PED
Dec 13,
7918833
Sep 23,
7918833*PED
Mar 23,

2014
2015
2023
2024
2023
2023
2027
2028

DS

DP

INSULIN GLULISINE RECOMBINANT - APIDRA

N021629 001 6221633
Jun 18,
6960561
Jan 25,
7452860
Mar 22,
7696162
Mar 22,

2018
2023
2022
2022

DS

INSULIN GLULISINE RECOMBINANT - APIDRA

N021629 002 6221633
Jun 18,
6960561
Jan 25,
7452860
Mar 22,
7696162
Mar 22,

2018
2023
2022
2022

DS

U-668
U-668

DP
DP
DP

DP
DP
DP
DP

U-471
U-471

DP
DP
DP
DP

U-471
U-471

NPP

Oct

24, 2011

NPP

Oct

24, 2011

U-471

U-471

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 98 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

INSULIN GLULISINE RECOMBINANT - APIDRA SOLOSTAR

N021629 003 6221633
Jun 18, 2018
DS
6960561
Jan 25, 2023
7452860
Mar 22, 2022
7696162
Mar 22, 2022
7918833
Sep 23, 2027

PATENT
CODES
DP
DP
DP
DP
DP

U-471
U-471

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)
NPP

EXCLUSIVITY
EXPIRATION
DATE

Oct

24, 2011

U-471

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 50/50
N021018 001 5461031
Jun 26, 2014
5474978
Jun 16, 2014
5514646
May 07, 2013
5747642
Jun 16, 2014
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 75/25
N021017 001 5461031
Jun 16, 2014
5474978
Jun 16, 2014
5514646
May 07, 2013
5747642
Jun 16, 2014
INSULIN LISPRO RECOMBINANT - HUMALOG
N020563 001 5474978
Jun 16, 2014
5514646
May 07, 2013

U-534
U-534

INSULIN LISPRO RECOMBINANT - HUMALOG PEN

N020563 002 5474978
Jun 16, 2014
5514646
May 07, 2013

U-534
U-534

INSULIN RECOMBINANT HUMAN - EXUBERA

N021868 001 5740794
Apr 21, 2015
5997848
Mar 07, 2014
6051256
Mar 07, 2014
6257233
May 14, 2019
6423344
Mar 07, 2014
6543448
Sep 21, 2014
6546929
May 14, 2019
6582728
Jun 24, 2020
6592904
Mar 07, 2014
6685967
Sep 11, 2018
6737045
Mar 07, 2014
INSULIN RECOMBINANT HUMAN - EXUBERA
N021868 002 5740794
Apr 21, 2015
5997848
Mar 07, 2014
6051256
Mar 07, 2014
6257233
May 14, 2019
6423344
Mar 07, 2014
6543448
Sep 21, 2014
6546929
May 14, 2019
6582728
Jun 24, 2020
6592904
Mar 07, 2014
6685967
Sep 11, 2018
6737045
Mar 07, 2014

DP
U-704
DP
U-704
DP
DP
U-704
DP
DP
DP
U-704

DP
U-704
DP
U-704
DP
DP
U-704
DP
DP
DP
U-704

INSULIN RECOMBINANT HUMAN - HUMULIN R

N018780 001

NR

Mar

25, 2014

INSULIN RECOMBINANT HUMAN - HUMULIN R PEN

N018780 005

NR

Mar

25, 2014

NCE
ODE

Sep
Sep

19, 2013
19, 2015

IOBENGUANE SULFATE I-123 - ADREVIEW

N022290 001
IODIXANOL - VISIPAQUE 270
N020351 001 5349085
5366722
RE36418

Sep
Nov
Jul

20, 2011
22, 2011
12, 2011

DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 99 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

IODIXANOL - VISIPAQUE 270

N020808 001 5349085
5366722
RE36418

Sep
Nov
Jul

20, 2011
22, 2011
12, 2011

DP
DP

IODIXANOL - VISIPAQUE 320

N020351 002 5349085
RE36418

Sep
Jul

20, 2011
12, 2011

DP

IODIXANOL - VISIPAQUE 320

N020808 002 5349085
RE36418

Sep
Jul

20, 2011
12, 2011

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

IOFLUPANE I-123 - DATSCAN

N022454 001

NCE

Jan

14, 2016

IOPROMIDE - ULTRAVIST (PHARMACY BULK)

N021425 002

I-619

Dec

30, 2012

IOPROMIDE - ULTRAVIST 370

N020220 001

I-619

Dec

30, 2012

NP

Apr

29, 2013

IPRATROPIUM BROMIDE - ATROVENT

N021527 001 5676930
5683677
6739333
6983743

HFA
Oct
Nov
May
May

14,
04,
26,
26,

2014
2014
2020
2020

IRBESARTAN - AVAPRO
N020757 001 5270317
5270317*PED
6342247
6342247*PED

Sep
Mar
Jun
Dec

30,
30,
07,
07,

2011
2012
2015
2015

IRBESARTAN - AVAPRO
N020757 002 5270317
5270317*PED
6342247
6342247*PED

Sep
Mar
Jun
Dec

30,
30,
07,
07,

2011
2012
2015
2015

IRBESARTAN - AVAPRO
N020757 003 5270317
5270317*PED
6342247
6342247*PED

Sep
Mar
Jun
Dec

30,
30,
07,
07,

2011
2012
2015
2015

DP
DP
DP
DP

IRINOTECAN HYDROCHLORIDE - CAMPTOSAR

Apr 28, 2020
N020571 001 6403569
Oct 28, 2020
6403569*PED
May 01, 2020
6794370
Nov 01, 2020
6794370*PED

U-449
U-606

IRINOTECAN HYDROCHLORIDE - CAMPTOSAR

N020571 002 6403569
Apr 28, 2020
6403569*PED
Oct 28, 2020
6794370
May 01, 2020
Nov 01, 2020
6794370*PED
IRON DEXTRAN - DEXFERRUM
A040024 001 5624668

Sep

29, 2015

ITRACONAZOLE - ONMEL
N022484 001 6509038
7081255

May
May

12, 2017
12, 2017

ITRACONAZOLE - SPORANOX
N020083 001 5633015

May

27, 2014

ITRACONAZOLE - SPORANOX
N020657 001 5707975
6407079

Jan
Jun

13, 2015
18, 2019

U-449
U-606

DP
DP

U-1054
U-1054

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 100 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ITRACONAZOLE - SPORANOX
N020966 001 6407079

Jun

18, 2019

IXABEPILONE - IXEMPRA KIT

N022065 001 6670384
6670384
6670384*PED
7022330
7022330*PED
7125899
7125899*PED
7312237
7312237*PED
RE41393
RE41393*PED
RE41911
RE41911*PED

Jan
Jan
Jul
Jan
Jul
May
Nov
Aug
Feb
Feb
Aug
May
Nov

23,
23,
23,
23,
23,
26,
26,
21,
21,
08,
08,
26,
26,

2022
2022
2022
2022
2022
2018
2018
2024
2025
2022
2022
2018
2018

IXABEPILONE - IXEMPRA KIT

N022065 002 6670384
6670384
6670384*PED
7022330
7022330*PED
7125899
7125899*PED
7312237
7312237*PED
RE41393
RE41393*PED
RE41911
RE41911*PED

Jan
Jan
Jul
Jan
Jul
May
Nov
Aug
Feb
Feb
Aug
May
Nov

23,
23,
23,
23,
23,
26,
26,
21,
21,
08,
08,
26,
26,

2022
2022
2022
2022
2022
2018
2018
2024
2025
2022
2022
2018
2018

KETOCONAZOLE - EXTINA
N021738 001 7553835

Oct

19, 2018

PATENT
CODES

DS

DP
DP

U-959
U-960

DP

U-958

DP

U-957

Apr

07, 2014

KETOCONAZOLE - XOLEGEL
N021946 001 7179475

Dec

04, 2018

KETOROLAC TROMETHAMINE - ACULAR LS

May
N021528 001 8008338

24, 2027

KETOROLAC TROMETHAMINE - ACUVAIL

Aug
N022427 001 7842714

15, 2029

KETOROLAC TROMETHAMINE - SPRIX

N022382 001 6333044
Dec
7476689
Oct

25, 2018
11, 2012

LACOSAMIDE - VIMPAT
N022253 001 5654301
RE38551

Aug
Mar

05, 2014
17, 2017

LACOSAMIDE - VIMPAT
N022253 002 5654301
RE38551

Aug
Mar

LACOSAMIDE - VIMPAT
N022253 003 5654301
RE38551
LACOSAMIDE - VIMPAT
N022253 004 5654301
RE38551

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

M-61
NCE
PED
PED

Oct
Oct
Apr
Apr

18,
16,
18,
16,

2014
2012
2015
2013

M-61
NCE
PED
PED

Oct
Oct
Apr
Apr

18,
16,
18,
16,

2014
2012
2015
2013

PC

Feb

21, 2012

NP

Jul

22, 2012

U-965
U-961
DS

DS

DP

U-961

DP
DP

U-960
U-959

DP

U-958

DP

U-957
U-965
U-961

DS

DP

U-961

DP

U-245

KETOCONAZOLE - KETOCONAZOLE
A091550 001
KETOCONAZOLE - NIZORAL A-D
N020310 001 5456851

PATENT
DELIST
REQUESTED

DP

U-792

U-1181

DS

DP

DP
DP

U-1057
U-1056

NDF

May

14, 2013

DS
DS

DP
DP

U-914
U-914

NCE

Oct

28, 2013

05, 2014
17, 2017

DS
DS

DP
DP

U-914
U-914

NCE

Oct

28, 2013

Aug
Mar

05, 2014
17, 2017

DS
DS

DP
DP

U-914
U-914

NCE

Oct

28, 2013

Aug
Mar

05, 2014
17, 2017

DS
DS

DP
DP

U-914
U-914

NCE

Oct

28, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 101 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

LACOSAMIDE - VIMPAT
N022254 001 5654301
RE38551

Aug
Mar

05, 2014
17, 2017

DS
DS

DP
DP

U-911
U-911

NCE

Oct

28, 2013

LACOSAMIDE - VIMPAT
N022255 001 5654301
RE38551

Aug
Mar

05, 2014
17, 2017

DS
DS

DP
DP

U-914
U-914

NCE

Oct

28, 2013

LAMIVUDINE - EPIVIR
N020564 001 5905082
5905082*PED

May
Nov

18, 2016
18, 2016

DS

DP

U-248

LAMIVUDINE - EPIVIR
N020564 003 5905082
5905082*PED

May
Nov

18, 2016
18, 2016

LAMIVUDINE - EPIVIR
N020596 001 6004968
6004968*PED

Mar
Sep

20, 2018
20, 2018

LAMIVUDINE - EPIVIR-HBV
N021003 001 5905082
5905082*PED
RE39155
RE39155*PED

May
Nov
Jul
Jan

18,
18,
02,
02,

2016
2016
2013
2014

LAMIVUDINE - EPIVIR-HBV
N021004 001 6004968
6004968*PED
RE39155
RE39155*PED

Mar
Sep
Jul
Jan

20,
20,
02,
02,

2018
2018
2013
2014

I-644
I-622
NDF
PED

Apr
Jan
May
Nov

25,
29,
29,
29,

LAMIVUDINE; ZIDOVUDINE - COMBIVIR

N020857 001 5859021
May
May
5905082
Nov
5905082*PED

15, 2012
18, 2016
18, 2016

LAMOTRIGINE - LAMICTAL CD
N020764 001 5698226
5698226*PED

Jan
Jul

29, 2012
29, 2012

LAMOTRIGINE - LAMICTAL CD
N020764 002 5698226
5698226*PED

Jan
Jul

29, 2012
29, 2012

LAMOTRIGINE - LAMICTAL CD
N020764 003 5698226
5698226*PED

Jan
Jul

29, 2012
29, 2012

LAMOTRIGINE - LAMICTAL CD
N020764 004 5698226
5698226*PED

Jan
Jul

29, 2012
29, 2012

LAMOTRIGINE - LAMICTAL ODT

N022251 001 7919115

Jan

LAMOTRIGINE - LAMICTAL ODT

N022251 002 7919115

U-250

U-250

DS
DS

DP
DP

04, 2029

DS

DP

Jan

04, 2029

DS

DP

LAMOTRIGINE - LAMICTAL ODT

N022251 003 7919115

Jan

04, 2029

DS

DP

LAMOTRIGINE - LAMICTAL ODT

N022251 004 7919115

Jan

04, 2029

DS

DP

LAMOTRIGINE - LAMICTAL XR
N022115 001

U-248
U-248
U-248

2014
2013
2012
2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 102 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LAMOTRIGINE - LAMICTAL XR
N022115 002

LAMOTRIGINE - LAMICTAL XR
N022115 003

LAMOTRIGINE - LAMICTAL XR
N022115 004

LAMOTRIGINE - LAMICTAL XR
N022115 005

LAMOTRIGINE - LAMICTAL XR
N022115 006

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-644
I-622
NDF
PED

Apr
Jan
May
Nov

15,
29,
29,
29,

2014
2013
2012
2012

I-644
I-622
NDF
PED

Apr
Jan
May
Nov

25,
29,
29,
29,

2014
2013
2012
2012

I-644
I-622
NDF
PED

Apr
Jan
May
Nov

25,
29,
29,
29,

2014
2013
2012
2012

I-644
I-622
NDF
PED

Apr
Jan
May
Nov

25,
29,
29,
29,

2014
2013
2012
2012

I-622
I-644
NDF
PED

Jan
Apr
May
Nov

29,
25,
29,
29,

2013
2014
2012
2012

LANREOTIDE ACETATE - SOMATULINE DEPOT

N022074 001 5595760
Mar 08, 2020

DP

U-831

D-131
NCE
ODE

Mar
Aug
Aug

04, 2014
30, 2012
30, 2014

LANREOTIDE ACETATE - SOMATULINE DEPOT

N022074 002 5595760
Mar 08, 2020

DP

U-831

D-131
NCE
ODE

Mar
Aug
Aug

04, 2014
30, 2012
30, 2014

LANREOTIDE ACETATE - SOMATULINE DEPOT

N022074 003 5595760
Mar 08, 2020

DP

U-831

D-131
NCE
ODE

Mar
Aug
Aug

04, 2014
30, 2012
30, 2014

M-85
PED

Oct
Apr

28, 2011
28, 2012

M-85
PED

Oct
Apr

28, 2011
28, 2012

M-85
PED

Oct
Apr

28, 2011
28, 2012

M-85
PED

Oct
Apr

28, 2011
28, 2012

LANSOPRAZOLE - PREVACID
N020406 001
LANSOPRAZOLE - PREVACID
N020406 002
LANSOPRAZOLE - PREVACID
N021281 001
LANSOPRAZOLE - PREVACID
N021281 002

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 103 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

LANSOPRAZOLE - PREVACID
N021428 001 5464632
5464632*PED
6328994
6328994*PED
7399485
7399485*PED
7431942
7431942*PED
7875292
7875292*PED

Nov
May
May
Nov
May
Nov
May
Nov
May
Nov

07,
07,
17,
17,
26,
26,
17,
17,
17,
17,

2012
2013
2019
2019
2018
2018
2019
2019
2019
2019

LANSOPRAZOLE - PREVACID
N021428 002 5464632
5464632*PED
6328994
6328994*PED
7399485
7399485*PED
7431942
7431942*PED
7875292
7875292*PED

Nov
May
May
Nov
May
Nov
May
Nov
May
Nov

07,
07,
17,
17,
26,
26,
17,
17,
17,
17,

2012
2013
2019
2019
2018
2018
2019
2019
2019
2019

PATENT
CODES

M-85
PED

Oct
Apr

28, 2011
28, 2012

M-85
PED

Oct
Apr

28, 2011
28, 2012

NP

May

18, 2012

I-620
NCE

Jan
Mar

29, 2013
13, 2012

DP

DP
DP
DP

17, 2021
17, 2022

DP

U-947

LANTHANUM CARBONATE - FOSRENOL

N021468 001 5968976
Oct
7381428
Aug
Aug
7465465

26, 2018
26, 2024
26, 2024

DP

U-613
U-890

LANTHANUM CARBONATE - FOSRENOL

N021468 002 5968976
Oct
7381428
Aug
Aug
7465465

26, 2018
26, 2024
26, 2024

DP

LANTHANUM CARBONATE - FOSRENOL

N021468 003 5968976
Oct
7381428
Aug
Aug
7465465

26, 2018
26, 2024
26, 2024

DP

LANTHANUM CARBONATE - FOSRENOL

Oct
N021468 004 5968976
Aug
7381428
Aug
7465465

26, 2018
26, 2024
26, 2024

DP

LAPATINIB DITOSYLATE - TYKERB

N022059 001 6391874
6713485
6727256
6828320
7157466

11,
29,
08,
11,
19,

2017
2020
2019
2017
2021

EXCLUSIVITY
EXPIRATION
DATE

DP

Aug
Feb

Jul
Sep
Jan
Jul
Nov

EXCLUSIVITY
CODE(S)

DP

LANSOPRAZOLE - PREVACID 24 HR
N022327 001
LANSOPRAZOLE - PREVACID IV
N021566 001 7396841
7396841*PED

PATENT
DELIST
REQUESTED

DP

U-613
U-890

DP

U-613
U-890

DP

U-613
U-890

DP

DS
DS
DS

DP
DP
DP

DS

DP

U-800
U-800
U-800
U-800

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 104 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LENALIDOMIDE - REVLIMID
N021880 001 5635517
6045501
6281230
6315720
6555554
6561976
6561977
6755784
6908432
7119106
7189740
7465800
7855217
7968569

Oct
Aug
Jul
Oct
Jul
Aug
Oct
Oct
Aug
Jul
Apr
Apr
Nov
Oct

04,
28,
24,
23,
24,
28,
23,
23,
28,
24,
11,
22,
24,
07,

2019
2018
2016
2020
2016
2018
2020
2020
2018
2016
2023
2026
2024
2023

DS

LENALIDOMIDE - REVLIMID
N021880 002 5635517
6045501
6281230
6315720
6555554
6561976
6561977
6755784
6908432
7119106
7189740
7465800
7855217
7968569

Oct
Aug
Jul
Oct
Jul
Aug
Oct
Oct
Aug
Jul
Apr
Apr
Nov
Oct

04,
28,
24,
23,
24,
28,
23,
23,
28,
24,
11,
22,
24,
07,

2019
2018
2016
2020
2016
2018
2020
2020
2018
2016
2023
2026
2024
2023

DS

LENALIDOMIDE - REVLIMID
N021880 003 5635517
6045501
6281230
6315720
6555554
6561976
6561977
6755784
6908432
7119106
7189740
7465800
7968569

Oct
Aug
Jul
Oct
Jul
Aug
Oct
Oct
Aug
Jul
Apr
Apr
Oct

04,
28,
24,
23,
24,
28,
23,
23,
28,
24,
11,
22,
07,

2019
2018
2016
2020
2016
2018
2020
2020
2018
2016
2023
2026
2023

DS

LENALIDOMIDE - REVLIMID
N021880 004 5635517
6045501
6281230
6315720
6555554
6561976
6561977
6755784
6908432
7119106
7189740
7465800
7855217
7968569

Oct
Aug
Jul
Oct
Jul
Aug
Oct
Oct
Aug
Jul
Apr
Apr
Nov
Oct

04,
28,
24,
23,
24,
28,
23,
23,
28,
24,
11,
22,
24,
07,

2019
2018
2016
2020
2016
2018
2020
2020
2018
2016
2023
2026
2024
2023

DS

LENALIDOMIDE - REVLIMID
N021880 005

U-866
U-694
U-769
U-694

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ODE
ODE

Jun
Dec

29, 2013
27, 2012

ODE
ODE

Jun
Dec

29, 2013
27, 2012

ODE

Jun

29, 2013

ODE

Jun

29, 2013

ODE
ODE

Dec
Jun

27, 2012
29, 2013

DP
U-694
U-694
U-694
U-694
DP
U-1079
DS
DS

DP
DP
U-1165

U-866
U-694
U-769
U-694
DP
U-694
U-694
U-694
U-694
DP
U-1079

DS
DS

DP
DP
U-1165

U-866
U-694
U-769
U-694
DP
U-694
U-694
U-694
U-694
DP
U-1079

DS

DP
U-1165

U-866
U-694
U-769
U-694
DP
U-694
U-694
U-694
U-694
DP
U-1079

DS
DS

DP
DP
U-1165

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 105 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LEUPROLIDE ACETATE - ELIGARD

N021343 001 5324519
5599552
6395293
6565874
6626870
6773714

Oct
Feb
Sep
Oct
Mar
Oct

20,
04,
28,
28,
27,
28,

2011
2014
2013
2018
2020
2018

DP
DP
DP
DP

LEUPROLIDE ACETATE - ELIGARD

N021379 001 5324519
5599552
6395293
6565874
6626870
6773714

Oct
Feb
Sep
Oct
Mar
Oct

20,
04,
28,
28,
27,
28,

2011
2014
2013
2018
2020
2018

DP
DP
DP
DP

LEUPROLIDE ACETATE - ELIGARD

N021488 001 5324519
5599552
6395293
6565874
6626870
6773714

Oct
Feb
Sep
Oct
Mar
Oct

20,
04,
28,
28,
27,
28,

2011
2014
2013
2018
2020
2018

DP
DP
DP
DP

LEUPROLIDE ACETATE - ELIGARD

N021731 001 5599552
6395293
6565874
6626870
6773714

Feb
Sep
Oct
Mar
Oct

04,
28,
28,
27,
28,

2014
2013
2018
2020
2018

LEUPROLIDE ACETATE - LUPRON DEPOT

N019732 001 5575987
Sep
5631020
May
Sep
5716640
Dec
6036976

02,
20,
02,
13,

2013
2014
2013
2016

LEUPROLIDE ACETATE - LUPRON DEPOT

Sep
N020011 001 5575987
May
5631021
Sep
5716640

02, 2013
20, 2014
02, 2013

LEUPROLIDE ACETATE - LUPRON DEPOT

Jan
N020517 001 5480656
Sep
5575987
May
5631020
Jan
5643607
Sep
5716640
Dec
6036976

02,
02,
20,
02,
02,
13,

2013
2013
2014
2013
2013
2016

LEUPROLIDE ACETATE - LUPRON DEPOT

Jan
N020517 002 5480656
Sep
5575987
May
5631020
Jan
5643607
Sep
5716640
Dec
6036976

02,
02,
20,
02,
02,
13,

2013
2013
2014
2013
2013
2016

LEUPROLIDE ACETATE - LUPRON DEPOT

N020517 003 6036976
Dec
7429559
Dec

13, 2016
13, 2016

LEUPROLIDE ACETATE - LUPRON DEPOT

N020708 001 5480656
Jan
5575987
Sep
May
5631020
Jan
5643607
Sep
5716640
Dec
6036976

02,
02,
20,
02,
02,
13,

2013
2013
2014
2013
2013
2016

DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-801
U-801
U-801

U-801
U-801

U-801
U-801

U-621
U-621
U-621

DP
DP

D-132
NS

Jun
Jun

17, 2014
17, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 106 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

LEUPROLIDE ACETATE - LUPRON DEPOT-PED

Sep 02,
N020263 002 5575987
May 20,
5631020
Sep 02,
5716640
Dec 13,
6036976

2013
2014
2013
2016

LEUPROLIDE ACETATE - LUPRON DEPOT-PED

Sep 02,
N020263 003 5575987
May 20,
5631020
Sep 02,
5716640
Dec 13,
6036976

2013
2014
2013
2013

LEUPROLIDE ACETATE - LUPRON DEPOT-PED

Sep 02,
N020263 004 5575987
May 20,
5631020
Sep 02,
5716640
Dec 13,
6036976

2013
2014
2013
2013

LEUPROLIDE ACETATE - LUPRON DEPOT-PED

Sep 02,
N020263 005 5575987
May 20,
5631020
Sep 02,
5716640
Dec 13,
6036976

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

M-107

Oct

08, 2014

2013
2014
2013
2016

M-107

Oct

08, 2014

LEUPROLIDE ACETATE - LUPRON DEPOT-PED

Sep 02,
N020263 006 5575987
May 20,
5631020
Sep 02,
5716640
Dec 13,
6036976

2013
2014
2013
2016

M-107

Oct

08, 2014

LEUPROLIDE ACETATE - LUPRON DEPOT-PED

Sep 02,
N020263 007 5575987
May 20,
5631020
Sep 02,
5716640
Dec 13,
6036976

2013
2014
2013
2016

DP
DP
DP
DP

NP

Aug

15, 2014

LEUPROLIDE ACETATE - LUPRON DEPOT-PED

N020263 008 5480656
Jan 02,
5575987
Sep 02,
May 20,
5631020
Jan 02,
5643607
Sep 02,
5716640
Dec 13,
6036976

2013
2013
2014
2013
2013
2016

DP
DP
DP
DP
DP
DP

NP

Aug

15, 2014

LEUPROLIDE ACETATE - VIADUR

N021088 001 5728396
5932547
5985305
6113938
6124261
6132420
6156331
6235712
6375978
6395292

2017
2017
2017
2018
2017
2017
2017
2017
2018
2017

Jan
Jun
Jan
Jul
Jun
Jan
Jan
Jun
Dec
Jan

30,
13,
30,
24,
13,
30,
30,
13,
17,
30,

U-316

LEVALBUTEROL HYDROCHLORIDE - XOPENEX

Mar 25, 2013
N020837 001 5362755
Aug 20, 2013
5547994
Mar 21, 2021
6451289

U-332
U-332

LEVALBUTEROL HYDROCHLORIDE - XOPENEX

Mar 25, 2013
N020837 002 5362755
Aug 20, 2013
5547994
Mar 21, 2021
6451289

U-332
U-332

LEVALBUTEROL HYDROCHLORIDE - XOPENEX

N020837 003 5362755
Mar 25, 2013
5547994
Aug 20, 2013
Mar 21, 2021
6451289

U-332
U-332

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 107 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LEVALBUTEROL HYDROCHLORIDE - XOPENEX

N020837 004 5362755
Mar 25, 2013
5547994
Aug 20, 2013
Mar 21, 2021
6451289

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-332
U-332
DP

LEVALBUTEROL TARTRATE - XOPENEX HFA

N021730 001 5362755
Mar
5547994
Aug
Feb
5605674
Nov
5836299
Oct
7256310

25,
20,
25,
17,
08,

LEVETIRACETAM - KEPPRA XR
N022285 001 7858122

Sep

17, 2028

DP

NDF

Sep

12, 2011

LEVETIRACETAM - KEPPRA XR
N022285 002 7858122

Sep

17, 2028

DP

NDF

Sep

12, 2011

LEVETIRACETAM - LEVETIRACETAM
A091093 001

PC

Mar

10, 2012

LEVETIRACETAM - LEVETIRACETAM
A091093 002

PC

Mar

10, 2012

LEVETIRACETAM - LEVETIRACETAM
A091261 002

PC

Mar

10, 2012

LEVETIRACETAM - LEVETIRACETAM
A091285 001

PC

Mar

10, 2012

LEVETIRACETAM - LEVETIRACETAM
A091285 002

PC

Mar

10, 2012

LEVETIRACETAM - LEVETIRACETAM
A091291 002

PC

Mar

10, 2012

LEVETIRACETAM - LEVETIRACETAM
A091399 001

PC

Mar

10, 2012

LEVETIRACETAM - LEVETIRACETAM
A091399 002

PC

Mar

10, 2012

LEVETIRACETAM - LEVETIRACETAM
A091430 001

PC

Mar

10, 2012

LEVETIRACETAM - LEVETIRACETAM
A091430 002

PC

Mar

10, 2012

LEVETIRACETAM - LEVETIRACETAM
A091557 001

PC

Mar

10, 2012

LEVETIRACETAM - LEVETIRACETAM
A091557 002

PC

Mar

10, 2012

2013
2013
2014
2015
2024

LEVOBETAXOLOL HYDROCHLORIDE - BETAXON

N021114 001 5540918
Jul 30, 2013
5540918*PED
Jan 30, 2014

U-636
U-636

DS

DP
DP
DP

U-636

DP

LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE

N020997 001 5708011
Oct 13, 2014

U-276

LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE

N020997 002 5708011
Oct 13, 2014

U-276

LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE

N020997 003 5708011
Oct 13, 2014

U-276

LEVOCARNITINE - CARNITOR
N020182 001 6335369
6429230
6696493

U-433
U-433
U-433

Jan
Jan
Jan

18, 2021
18, 2021
18, 2021

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 108 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

LEVOCETIRIZINE DIHYDROCHLORIDE - XYZAL

Sep 24, 2012
N022064 001 5698558
Mar 24, 2013
5698558*PED

U-812

NPP
PED

Aug
Feb

21, 2012
21, 2013

LEVOCETIRIZINE DIHYDROCHLORIDE - XYZAL

Sep 24, 2012
N022157 001 5698558
Mar 24, 2013
5698558*PED

U-852

NPP
PED

Aug
Feb

21, 2012
21, 2013

LEVOFLOXACIN - LEVAQUIN
N021721 001 6806256
6806256*PED

Feb
Aug

26, 2022
26, 2022

LEVOLEUCOVORIN CALCIUM - FUSILEV

N020140 001 6500829
Dec

31, 2019

DS

DP

I-637
ODE
ODE

Apr
Apr
Mar

29, 2014
29, 2018
07, 2015

LEVOLEUCOVORIN CALCIUM - FUSILEV

N020140 002 6500829
Dec

31, 2019

DS

DP

I-637
ODE
ODE

Apr
Apr
Mar

29, 2014
29, 2018
07, 2015

LEVOLEUCOVORIN CALCIUM - FUSILEV

N020140 003 6500829
Dec

31, 2019

DS

DP

I-637
ODE
ODE

Apr
Apr
Mar

29, 2014
29, 2018
07, 2015

LEVONORGESTREL - MIRENA
N021225 001 5785053

05, 2015

DP

I-610

Oct

01, 2012

NP

Jul

10, 2012

Dec

LEVONORGESTREL - PLAN B ONE-STEP

N021998 001
LEVOTHYROXINE SODIUM - LEVO-T
N021342 001 6399101

Mar

30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N021342 002 6399101

Mar

30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N021342 003 6399101

Mar

30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N021342 004 6399101

Mar

30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N021342 005 6399101

Mar

30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N021342 006 6399101

Mar

30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N021342 007 6399101

Mar

30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N021342 008 6399101

Mar

30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N021342 009 6399101

Mar

30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N021342 010 6399101

Mar

30, 2020

LEVOTHYROXINE SODIUM - LEVO-T

N021342 011 6399101

Mar

30, 2020

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 109 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LEVOTHYROXINE SODIUM - LEVOXYL

Feb
N021301 001 6555581
Feb
7067148
Aug
7101569

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N021301 002 6555581
Feb
7067148
Feb
7101569
Aug

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - LEVOXYL

Feb
N021301 003 6555581
Feb
7067148
Aug
7101569

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N021301 004 6555581
Feb
7067148
Feb
7101569
Aug

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - LEVOXYL

Feb
N021301 005 6555581
Feb
7067148
Aug
7101569

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - LEVOXYL

Feb
N021301 006 6555581
Feb
7067148
Aug
7101569

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N021301 007 6555581
Feb
7067148
Feb
7101569
Aug

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - LEVOXYL

Feb
N021301 008 6555581
Feb
7067148
Aug
7101569

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - LEVOXYL

Feb
N021301 009 6555581
Feb
7067148
Aug
7101569

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - LEVOXYL

N021301 010 6555581
Feb
7067148
Feb
7101569
Aug

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - LEVOXYL

Feb
N021301 011 6555581
Feb
7067148
Aug
7101569

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - LEVOXYL

Feb
N021301 012 6555581
Feb
7067148
Aug
7101569

15, 2022
15, 2022
14, 2022

DP

LEVOTHYROXINE SODIUM - TIROSINT

N021924 002 7723390
Mar

14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N021924 003 7723390
Mar

14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N021924 004 7723390
Mar

14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N021924 005 7723390
Mar

14, 2024

DP

U-759

U-759

U-759

U-759

U-759

U-759

U-759

U-759

U-759

U-759

U-759

U-759

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 110 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LEVOTHYROXINE SODIUM - TIROSINT

N021924 006 7723390
Mar

14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N021924 007 7723390
Mar

14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N021924 008 7723390
Mar

14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N021924 009 7723390
Mar

14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N021924 010 7723390
Mar

14, 2024

DP

LEVOTHYROXINE SODIUM - TIROSINT

N022121 001 7723390
Mar

14, 2024

DP

LIDOCAINE - DENTIPATCH
N020575 001 5332576

Jul

26, 2011

LIDOCAINE - DENTIPATCH
N020575 002 5332576

Jul

26, 2011

LIDOCAINE - LIDODERM
N020612 001 5411738
5601838
5741510
5827529

May
May
Mar
Oct

02,
02,
30,
27,

2012
2012
2014
2015

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-488
DP
U-486

LIDOCAINE HYDROCHLORIDE - AKTEN

N022221 001
LIDOCAINE HYDROCHLORIDE - ZINGO
May
N022114 001 5630796
May
5899880
Mar
6004286
Jun
6881200

20,
04,
17,
11,

2014
2016
2017
2016

DP
DP
DP

LIDOCAINE; PRILOCAINE - ORAQIX

Apr
N021451 001 6031007

01, 2017

DP

LIDOCAINE; TETRACAINE - LIDOCAINE AND TETRACAINE

N021717 001 5919479
Jul 28, 2015
6528086
Sep 28, 2019

DP
DP

LIDOCAINE; TETRACAINE - SYNERA

N021623 001 5658583
Jul
5919479
Jul
6306431
Jul
6465006
Jul
6546281
Jul
6780426
Jul

28,
28,
28,
28,
28,
28,

2015
2015
2015
2015
2015
2015

DP
DP
DP
DP
DP
DP

LINAGLIPTIN - TRADJENTA
N201280 001 6303661
6890898
7078381
7407955
7459428

Apr
Feb
Feb
Aug
Feb

24,
02,
02,
12,
02,

2017
2019
2019
2023
2019

LINEZOLID - ZYVOX
N021130 001 5688792
5688792*PED
6514529
6514529*PED
6559305
6559305*PED

Nov
May
Mar
Sep
Jan
Jul

18,
18,
15,
15,
29,
29,

2014
2015
2021
2021
2021
2021

DP
U-493

DS

U-319
DP

DS

Oct

07, 2011

NPP

Jan

08, 2012

NCE

May

02, 2016

U-553

U-774
U-493
U-493
DS

NDF

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 111 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LINEZOLID - ZYVOX
N021130 002 5688792
5688792*PED
6514529
6514529*PED
6559305
6559305*PED

Nov
May
Mar
Sep
Jan
Jul

18,
18,
15,
15,
29,
29,

2014
2015
2021
2021
2021
2021

LINEZOLID - ZYVOX
N021131 001 5688792
5688792*PED
6559305
6559305*PED

Nov
May
Jan
Jul

18,
18,
29,
29,

2014
2015
2021
2021

LINEZOLID - ZYVOX
N021132 001 5688792
5688792*PED
6559305
6559305*PED

Nov
May
Jan
Jul

18,
18,
29,
29,

2014
2015
2021
2021

DS

22, 2017
22, 2017
22, 2017

DS
DS
DS

LIRAGLUTIDE RECOMBINANT - VICTOZA

N022341 001 6268343
Aug
Aug
6458924
Aug
7235627

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N021977 001 7105486
Jun 29,
7223735
Jun 29,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7671030
Feb 24,
7671031
Feb 28,
7674774
Mar 18,
7678770
Mar 25,
7678771
Mar 25,
7687466
Feb 24,
7687467
Apr 08,
Jun 29,
7700561
Feb 24,
7718619
Feb 24,
7723305

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

Jun 29,
N021977 002 7105486
Jun 29,
7223735
Feb 24,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7671030
Feb 28,
7671031
Mar 18,
7674774
Mar 25,
7678770
Mar 25,
7678771
Feb 24,
7687466
Apr 08,
7687467
Jun 29,
7700561
Feb 24,
7718619
Feb 24,
7723305

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

DS

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-319
DP

DS

U-319
DS

U-319

DS

DP
DP
DP

U-968
U-968

NCE

Jan

25, 2015

U-727

M-82
NPP
NCE

Apr
Nov
Feb

05, 2013
10, 2013
23, 2012

M-82
NPP
NCE

Apr
Nov
Feb

05, 2013
10, 2013
23, 2012

DP
DS
DS

DP

U-727
U-1034

DP

U-727
U-727
U-842
U-842
U-842

DS

DP
DP
DP
DP
DP
DP
DP

U-842
U-842
U-842

U-727
DP
DS
DS

DP

U-727
U-1034

DP

U-727
U-727
U-842
U-842
U-842

DS

DP
DP
DP
DP
DP
DP
DP

U-842
U-842
U-842

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 112 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

Jun 29,
N021977 003 7105486
Jun 29,
7223735
Feb 24,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7671030
Feb 28,
7671031
Mar 18,
7674774
Mar 25,
7678770
Mar 25,
7678771
Feb 24,
7687466
Apr 08,
7687467
Jun 29,
7700561
Feb 24,
7718619
Feb 24,
7723305

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N021977 004 7105486
Jun 29,
7223735
Jun 29,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7671031
Feb 28,
7678770
Mar 25,
7687466
Feb 24,
7700561
Jun 29,

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

Jun 29,
N021977 005 7105486
Jun 29,
7223735
Feb 24,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7671030
Feb 28,
7671031
Mar 18,
7674774
Mar 25,
7678770
Mar 25,
7678771
Feb 24,
7687466
Apr 08,
7687467
Jun 29,
7700561
Feb 24,
7718619
Feb 24,
7723305

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

LISDEXAMFETAMINE DIMESYLATE - VYVANSE

N021977 006 7105486
Jun 29,
7223735
Jun 29,
7655630
Feb 24,
7659253
Feb 24,
7659254
Feb 24,
7662787
Feb 24,
7671030
Feb 24,
7671031
Feb 28,
7674774
Mar 18,
7678770
Mar 25,
7678771
Mar 25,
7687466
Feb 24,
7687467
Apr 08,
Jun 29,
7700561
Feb 24,
7718619
Feb 24,
7723305

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

LODOXAMIDE TROMETHAMINE - ALOMIDE

N020191 001 5457126
Oct

10, 2012

PATENT
CODES
U-727
DP
DS
DS

DP

U-727
U-1034

DP

U-727
U-727
U-842
U-842
U-842

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

M-82
NPP
NCE

Apr
Nov
Feb

05, 2013
10, 2013
23, 2012

M-82
NPP
NCE

Apr
Nov
Feb

05, 2013
10, 2013
23, 2012

M-82
NPP
NCE

Apr
Nov
Feb

05, 2013
10, 2013
23, 2012

M-82
NPP
NCE

Apr
Nov
Feb

05, 2013
10, 2013
23, 2012

DS

DP
DP
DP
DP
DP
DP
DP

U-842
U-842
U-842

U-842
DP
DS
DS

DP

U-727
U-1034

DS
U-727
U-842
DP
DP

U-842
DP
DS
DS

DP

U-727
U-1034

DP

U-727
U-727
U-842
U-842
U-842

DS

DP
DP
DP
DP
DP
DP
DP

U-842
U-842
U-842

U-842
DP
DS
DS

DP

U-727
U-1034

DP

U-727
U-727
U-842
U-842
U-842

DS

DP
DP
DP
DP
DP
DP
DP

U-842
U-842
U-842

U-117

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 113 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LOPERAMIDE HYDROCHLORIDE - IMODIUM A-D EZ CHEWS

N020448 001 5489436
Feb 06, 2013
6814978
Aug 26, 2021
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE N020606 001 5489436
Feb 06,
5679376
Oct 21,
5716641
May 21,

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP

IMODIUM MULTI-SYMPTOM RELIEF

2013
Y
2014
2012
U-226
Y

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE - IMODIUM MULTI-SYMPTOM RELIEF

N021140 001 6103260
Jul 17, 2017
DP
LOPINAVIR; RITONAVIR - KALETRA
N021226 001 5541206
5541206*PED
5648497
5648497*PED
5886036
5886036*PED
5914332
5914332*PED
5948436
5948436*PED
6037157
6037157*PED
6232333
6232333*PED
6284767
6284767
6284767*PED
6458818
6458818*PED
6521651
6521651*PED
6703403
6703403*PED
7141593
7141593*PED
7432294
7432294*PED

Jul
Jan
Jul
Jan
Nov
May
Dec
Jun
Sep
Mar
Jun
Dec
Nov
May
Feb
Feb
Aug
Nov
May
Nov
May
Jun
Dec
May
Nov
May
Nov

30,
30,
15,
15,
19,
19,
13,
13,
13,
13,
26,
26,
07,
07,
15,
15,
15,
07,
07,
07,
07,
26,
26,
22,
22,
22,
22,

2013
2014
2014
2015
2013
2014
2015
2016
2013
2014
2016
2016
2017
2018
2016
2016
2016
2017
2018
2017
2018
2016
2016
2020
2020
2020
2020

LOPINAVIR; RITONAVIR - KALETRA

N021251 001 5484801
5484801*PED
5541206
5541206
5541206*PED
5648497
5648497*PED
5886036
5886036*PED
5914332
5914332
5914332*PED
5948436
5948436*PED
6037157
6037157
6037157*PED
6284767
6284767
6284767*PED
6703403
6703403
6703403*PED
6911214
6911214*PED

Jan
Jul
Jul
Jul
Jan
Jul
Jan
Nov
May
Dec
Dec
Jun
Sep
Mar
Jun
Jun
Dec
Feb
Feb
Aug
Jun
Jun
Dec
Nov
May

28,
28,
30,
30,
30,
15,
15,
19,
19,
13,
13,
13,
13,
13,
26,
26,
26,
15,
15,
15,
26,
26,
26,
28,
28,

2014
2014
2013
2013
2014
2014
2015
2013
2014
2015
2015
2016
2013
2014
2016
2016
2016
2016
2016
2016
2016
2016
2016
2021
2022

DS

DS

U-348

DP
U-351
DP
U-346

DP
DP

U-688
U-401

DP
U-257
DP
DP

DP
DS
DS

D-124

DP
DP

U-348
U-895

DS

DP

U-895

DS
DS

DP
DP

U-895
U-351

DS

DP
U-895
U-346
DP
DP

U-895
U-401
U-257
U-895

DP

U-895

Apr

27, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 114 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LOPINAVIR; RITONAVIR - KALETRA

N021906 001 5541206
5541206*PED
5648497
5648497*PED
5886036
5886036*PED
5914332
5914332*PED
6037157
6037157*PED
6284767
6284767*PED
6703403
6703403*PED
7148359
7148359*PED
7364752
7364752*PED
8025899
8025899*PED

Jul
Jan
Jul
Jan
Nov
May
Dec
Jun
Jun
Dec
Feb
Aug
Jun
Dec
Jul
Jan
Nov
May
Sep
Mar

30,
30,
15,
15,
19,
19,
13,
13,
26,
26,
15,
15,
26,
26,
19,
19,
10,
10,
26,
26,

2013
2014
2014
2015
2013
2014
2015
2016
2016
2016
2016
2016
2016
2016
2019
2020
2020
2021
2027
2028

DS

DP

DS

DP

DS

DP

U-895

DS

DP

U-688

LOPINAVIR; RITONAVIR - KALETRA

N021906 002 5541206
5541206*PED
5648497
5648497*PED
5886036
5886036*PED
5914332
5914332*PED
6037157
6037157*PED
6284767
6284767*PED
6703403
6703403*PED
7148359
7148359*PED
7364752
7364752*PED
8025899
8025899*PED

Jul
Jan
Jul
Jan
Nov
May
Dec
Jun
Jun
Dec
Feb
Aug
Jun
Dec
Jul
Jan
Nov
May
Sep
Mar

30,
30,
15,
15,
19,
19,
13,
13,
26,
26,
15,
15,
26,
26,
19,
19,
10,
10,
26,
26,

2013
2014
2014
2015
2013
2014
2015
2016
2016
2016
2016
2016
2016
2016
2019
2020
2020
2021
2027
2028

DS

DP

DS

DP

DS

DP

U-895

DS

DP

U-688

LORATADINE - CLARITIN
N020641 002 6132758

Jun

01, 2018

U-688

Mar
Sep
Oct
Apr
Oct
Apr

09,
09,
25,
25,
25,
25,

2012
2012
2013
2014
2013
2014

LOTEPREDNOL ETABONATE - LOTEMAX

N020583 001 4996335
Mar
4996335*PED
Sep
5540930
Oct
5540930*PED
Apr
5747061
Oct
5747061*PED
Apr

09,
09,
25,
25,
25,
25,

2012
2012
2013
2014
2013
2014

LOTEPREDNOL ETABONATE - LOTEMAX

N020841 001 5540930
Oct

25, 2013

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

D-124

Apr

27, 2013

D-124

Apr

27, 2013

U-688
DP

U-688
U-688

DP
DP

U-688

DP

U-688

U-688
DP

U-688
U-688

DP
DP

U-688

DP

LORATADINE; PSEUDOEPHEDRINE SULFATE - CLARITIN-D 24 HOUR

N020470 002 5314697
Oct 23, 2012
LOTEPREDNOL ETABONATE - ALREX
N020803 001 4996335
4996335*PED
5540930
5540930*PED
5747061
5747061*PED

PATENT
DELIST
REQUESTED

DP

U-576

DP

U-575

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 115 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LOTEPREDNOL ETABONATE - LOTEMAX

N200738 001

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)
NDF
PED

LOTEPREDNOL ETABONATE; TOBRAMYCIN N050804 001 4996335

Mar
4996335*PED
Sep
Oct
5540930
Apr
5540930*PED
Oct
5747061
Apr
5747061*PED

ZYLET
09, 2012
09, 2012
25, 2013
25, 2014
25, 2013
25, 2014

LOVASTATIN - ALTOPREV
N021316 001 5916595
6080778
6485748

Dec
Mar
Dec

12, 2017
23, 2018
12, 2017

DP

LOVASTATIN - ALTOPREV
N021316 002 5916595
6080778
6485748

Dec
Mar
Dec

12, 2017
23, 2018
12, 2017

DP

LOVASTATIN - ALTOPREV
N021316 003 5916595
6080778
6485748

Dec
Mar
Dec

12, 2017
23, 2018
12, 2017

DP

LOVASTATIN - ALTOPREV
N021316 004 5916595
6080778
6485748

Dec
Mar
Dec

12, 2017
23, 2018
12, 2017

DP

LOVASTATIN; NIACIN - ADVICOR

N021249 001 6080428
6080428
6080428
6080428
6129930
6129930
6129930
6129930
6406715
6469035
6469035
6469035
6469035
6676967
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7011848
7998506
7998506
7998506

May
May
May
May
Sep
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
27,
20,
20,
20,
20,
20,
15,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2017
2017
2017
2017
2013
2013
2013
2013
2013
2018
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

DS

DP

U-920

DP
DP

U-920

U-456

U-456

U-456

U-456

DP
DP
DP
DP
DP

DP
DP

U-1134
U-1133
U-447
U-1132
U-1134
U-1133
U-448
U-1132
U-450
U-1131
U-768
U-1130
U-1129
U-548
U-1133
U-1132
U-1134
U-586
U-1136
U-1137
U-712
U-1135
U-1135
U-1136
U-1137

EXCLUSIVITY
EXPIRATION
DATE

Apr
Oct

15, 2014
15, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 116 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

LOVASTATIN; NIACIN - ADVICOR

N021249 002 6080428
6080428
6080428
6080428
6129930
6129930
6129930
6129930
6406715
6469035
6469035
6469035
6469035
6676967
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7011848
7998506
7998506
7998506

May
May
May
May
Sep
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
27,
20,
20,
20,
20,
20,
15,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2017
2017
2017
2017
2013
2013
2013
2013
2013
2018
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

LOVASTATIN; NIACIN - ADVICOR

N021249 003 6080428
6080428
6080428
6080428
6129930
6129930
6129930
6129930
6406715
6469035
6469035
6469035
6469035
6676967
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7011848
7998506
7998506
7998506

May
May
May
May
Sep
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
27,
20,
20,
20,
20,
20,
15,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2017
2017
2017
2017
2013
2013
2013
2013
2013
2018
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

PATENT
CODES

DP
DP
DP
DP
DP

DP
DP

U-1134
U-1132
U-1133
U-447
U-448
U-1132
U-1134
U-1133
U-450
U-1129
U-768
U-1131
U-1130
U-1134
U-548
U-1133
U-1132
U-586
U-712
U-1135
U-1137
U-1136
U-1135
U-1136
U-1137

DP
DP
DP
DP
DP

DP
DP

U-1133
U-1134
U-447
U-1132
U-1133
U-1134
U-1132
U-448
U-450
U-1131
U-1129
U-768
U-1130
U-1132
U-1134
U-1133
U-548
U-586
U-1136
U-712
U-1137
U-1135
U-1135
U-1137
U-1136

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 117 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

LOVASTATIN; NIACIN - ADVICOR

N021249 004 6080428
6080428
6080428
6080428
6129930
6129930
6129930
6129930
6406715
6469035
6469035
6469035
6469035
6676967
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7011848
7998506
7998506
7998506

May
May
May
May
Sep
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
27,
20,
20,
20,
20,
20,
15,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2017
2017
2017
2017
2013
2013
2013
2013
2013
2018
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

LUBIPROSTONE - AMITIZA
N021908 001 5284858
6414016
6583174
7064148
7417067
8026393
8071613
8088934

Jul
Sep
Oct
Aug
Oct
Oct
Sep
May

14,
05,
16,
30,
16,
25,
05,
18,

2014
2020
2020
2022
2020
2027
2020
2021

DS

LUBIPROSTONE - AMITIZA
N021908 002 5284858
6414016
6583174
7064148
7064148
7417067
7795312
8026393
8071613
8088934

Jul
Sep
Oct
Aug
Aug
Oct
Sep
Oct
Sep
May

14,
05,
16,
30,
30,
16,
17,
25,
05,
18,

2014
2020
2020
2022
2022
2020
2024
2027
2020
2021

DS

LURASIDONE HYDROCHLORIDE - LATUDA

N200603 001 5532372
Jul

02, 2013

DS

NCE

Oct

28, 2015

LURASIDONE HYDROCHLORIDE - LATUDA

N200603 002 5532372
Jul

02, 2013

DS

NCE

Oct

28, 2015

LUTROPIN ALFA - LUVERIS

N021322 001 5767251

16, 2015

DS

ODE

Oct

08, 2011

ODE

Jul

26, 2013

ODE

Jul

26, 2013

Jun

DP
DP
DP
DP
DP

DP
DP

U-1134
U-1132
U-1133
U-447
U-1133
U-1132
U-1134
U-448
U-1130
U-1129
U-1131
U-768
U-548
U-1132
U-1134
U-1133
U-586
U-1137
U-712
U-1136
U-1135
U-1135
U-1136
U-1137

U-717
DP
U-739
DP
DP
U-1203
DS

U-874
DP
U-739
U-873
DP
U-1085
DP
U-1202
DS

MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 25

N021910 001 5945449
Oct 31, 2017
DP U-785
7300674
Mar 04, 2023
DP U-785
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 35
N021910 002 5945449
Oct 31, 2017
DP U-785

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 118 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM

BICARBONATE
N022456 001 6489346
Jul 16,
6489346
Jul 16,
6645988
Jul 16,
6699885
Jul 16,
6699885
Jul 16,
7399772
Jul 16,
7399772
Jul 16,

BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM

BICARBONATE
N022456 002 6489346
Jul 16,
6489346
Jul 16,
6645988
Jul 16,
6699885
Jul 16,
6699885
Jul 16,
7399772
Jul 16,
7399772
Jul 16,

BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM

N021850 001 6489346
Jul 16,
6645988
Jul 16,
6699885
Jul 16,
7399772
Jul 16,

BICARBONATE - ZEGERID
2016
DS DP U-588
DS DP U-588
2016
U-588
2016
2016
U-588

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM

N021850 002 6489346
Jul 16,
6645988
Jul 16,
6699885
Jul 16,
7399772
Jul 16,

BICARBONATE - ZEGERID
2016
DS DP U-623
DS DP U-623
2016
2016
U-623
U-623
2016

2016
2016
2016
2016
2016
2016
2016

DP
DP
DP
DP
DP
DP
DP

2016
2016
2016
2016
2016
2016
2016

DP
DP
DP
DP
DP
DP
DP

U-588
U-1021
U-588
U-1021
U-1021
U-588

U-1021
U-588
U-588
U-1021
U-588
U-1021

MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE - SUPREP BOWEL PREP KIT
N022372 001 6946149
Apr 30, 2022
DP U-837
NC
MALATHION - OVIDE
N018613 001 7560445
7977324

Feb
Aug

01, 2027
14, 2026

MANGAFODIPIR TRISODIUM - TESLASCAN

N020652 001 4933456
Nov

27, 2011

MANNITOL - ARIDOL KIT

N022368 001 5817028

Feb

23, 2015

MARAVIROC - SELZENTRY
N022128 001 6586430
6667314
7368460
7576097

Dec
Aug
Nov
May

01,
06,
25,
25,

2019
2021
2022
2021

DS
DS

MARAVIROC - SELZENTRY
N022128 002 6586430
6667314
7368460
7576097

Dec
Aug
Nov
May

01,
06,
25,
25,

2019
2021
2022
2021

DS
DS

MECASERMIN RECOMBINANT - INCRELEX

N021839 001 5681814
Sep
5824642
Jul
6207640
Apr

18, 2017
08, 2014
07, 2014

DS

DP
DP

16, 2011

U-986

NP

Oct

05, 2013

DP
DP

U-824
U-824
U-824

NPP
NCE

May
Aug

28, 2013
06, 2012

DP
DP

U-824
U-824
U-824

NPP
NCE

May
Aug

28, 2013
06, 2012

ODE

Aug

30, 2012

ODE

Dec

12, 2012

DS

DS

DP

MEDROXYPROGESTERONE ACETATE - DEPO-SUBQ PROVERA 104

DP
N021583 001 6495534
May 15, 2020

Aug

05, 2013

U-1091

MECASERMIN RINFABATE RECOMBINANT - IPLEX

N021884 001 5681818
Oct 28, 2014

MEGESTROL ACETATE - MEGACE

N020264 001 5338732

Aug

U-681
U-681

U-697

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 119 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

MEGESTROL ACETATE - MEGACE ES

N021778 001 6592903
7101576

PATENT
EXPIRATION
DATE

Sep
Apr

PATENT
CODES

21, 2020
22, 2024

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
U-755

MELOXICAM - MOBIC
N020938 001
MELOXICAM - MOBIC
N020938 002
MELOXICAM - MOBIC
N021530 001 6184220
6184220*PED

PATENT
DELIST
REQUESTED

DP

ODE
PED

Aug
Feb

11, 2012
11, 2013

ODE
PED

Aug
Feb

11, 2012
11, 2013

ODE
PED

Aug
Feb

11, 2012
11, 2013

Mar
Sep

25, 2019
25, 2019

MEMANTINE HYDROCHLORIDE - NAMENDA

N021487 001 5061703
Apr

11, 2015

U-539

MEMANTINE HYDROCHLORIDE - NAMENDA

Apr
N021487 002 5061703

11, 2015

U-539

MEMANTINE HYDROCHLORIDE - NAMENDA

Apr
N021627 001 5061703

11, 2015

U-539

MEMANTINE HYDROCHLORIDE - NAMENDA XR

N022525 001 5061703
Apr 11, 2015
8039009
Mar 24, 2029

U-539
U-539

NDF

Jun

21, 2013

MEMANTINE HYDROCHLORIDE - NAMENDA XR

Apr 11, 2015
N022525 002 5061703
Mar 24, 2029
8039009

U-539
U-539

NDF

Jun

21, 2013

MEMANTINE HYDROCHLORIDE - NAMENDA XR

Apr 11, 2015
N022525 003 5061703
Mar 24, 2029
8039009

U-539
U-539

NDF

Jun

21, 2013

MEMANTINE HYDROCHLORIDE - NAMENDA XR

Apr 11, 2015
N022525 004 5061703
Mar 24, 2029
8039009

U-539
U-539

NDF

Jun

21, 2013

NP

Oct

31, 2011

I-640

Jul

14, 2014

MEQUINOL; TRETINOIN - SOLAGE

N020922 001 5194247
6353029

Dec
Aug

10, 2013
24, 2020

MESALAMINE - APRISO
N022301 001 6551620

Apr

20, 2018

MESALAMINE - ASACOL
N019651 001 5541170
5541171

Jul
Jul

30, 2013
30, 2013

MESALAMINE - ASACOL HD
N021830 001 5541170
5541171
6893662

Jul
Jul
Nov

30, 2013
30, 2013
15, 2021

DP
DP
DP

MESALAMINE - LIALDA
N022000 001 6773720

Jun

08, 2020

DP

MESALAMINE - SFROWASA
N019618 002 7645801

Jul

24, 2027

MESNA - MESNEX
N020855 001 5252341
5262169

Jul
Jul

16, 2011
16, 2011

METAXALONE - SKELAXIN
N013217 001 6407128
6683102

Dec
Dec

03, 2021
03, 2021

DS

DP

U-294

DP

U-907

U-141
U-141

DS

U-141
U-141
U-141

DP

U-189
U-189

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 120 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

METAXALONE - SKELAXIN
N013217 003 6407128
6683102
7122566
7714006

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-189
U-189
U-915
U-1050

Dec
Dec
Feb
Dec

03,
03,
06,
03,

2021
2021
2026
2021

METFORMIN HYDROCHLORIDE - FORTAMET

N021574 001 6099859
Mar
6495162
Mar
6790459
Mar
6866866
Mar
7919116
Mar

20,
20,
17,
17,
20,

2018
2018
2021
2021
2018

DP
DP

METFORMIN HYDROCHLORIDE - FORTAMET

N021574 002 6099859
Mar
6495162
Mar
6790459
Mar
6866866
Mar
7919116
Mar

20,
20,
17,
17,
20,

2018
2018
2021
2021
2018

DP
DP

U-604
DP
DP

U-604
DP
DP

METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR

N021202 001 6475521
Mar 19, 2018
6660300
Mar 19, 2018

U-542

METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR

N021202 004 6475521
Mar 19, 2018
6660300
Mar 19, 2018

U-542

METFORMIN HYDROCHLORIDE - GLUMETZA

N021748 001 6340475
Sep
6488962
Jun
6635280
Sep
Oct
6723340

19,
20,
19,
25,

2016
2020
2016
2021

DS
DS
DS
DS

DP
DP
DP
DP

METFORMIN HYDROCHLORIDE - GLUMETZA

N021748 002 6488962
Jun
7780987
Mar

20, 2020
23, 2025

DS
DS

DP
DP

U-669

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE

A090692 001

PC

Mar

28, 2012

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE

A090692 002

PC

Mar

28, 2012

METFORMIN HYDROCHLORIDE - RIOMET

Sep
N021591 001 6890957

14, 2023

DP

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET

N021842 001 5965584
DP U-1055
Jun 19, 2016
U-679
6166042
Jun 19, 2016
U-679
6166043
Jun 19, 2016
U-679
6172090
Jun 19, 2016
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET
DP U-1055
N021842 002 5965584
Jun 19, 2016
U-679
6166042
Jun 19, 2016
U-679
6166043
Jun 19, 2016
U-679
6172090
Jun 19, 2016

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 121 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

N022024 001 5965584
Jun 19, 2016
6099859
Mar 20, 2018
6166042
Jun 19, 2016
6166043
Jun 19, 2016
6172090
Jun 19, 2016
6495162
Mar 20, 2018
6790459
Mar 17, 2021
6866866
Mar 17, 2021
7785627
Jul 31, 2026
7919116
Mar 20, 2018
7919116
Mar 20, 2018
7959946
Jul 31, 2026

- ACTOPLUS MET XR
DP U-973
DP
U-973
U-973
U-973
DP
U-974
DP
DP
U-973
U-1120
DP

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

N022024 002 5965584
Jun 19, 2016
6099859
Mar 20, 2018
6166042
Jun 19, 2016
6166043
Jun 19, 2016
6172090
Jun 19, 2016
6495162
Mar 20, 2018
6790459
Mar 17, 2021
6866866
Mar 17, 2021
7785627
Jul 31, 2026
7919116
Mar 20, 2018
7919116
Mar 20, 2018
7959946
Jul 31, 2026

- ACTOPLUS MET XR
DP U-973
DP
U-973
U-973
U-973
DP
U-974
DP
DP
U-973
U-1120
DP

METFORMIN HYDROCHLORIDE; REPAGLINIDE - PRANDIMET

N022386 001 6677358
Jun 12, 2018

DP

U-546

METFORMIN HYDROCHLORIDE; REPAGLINIDE - PRANDIMET

N022386 002 6677358
Jun 12, 2018

DP

U-546

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET

DS DP U-493
N021410 001 5002953
Sep 17, 2011
Sep 17, 2011
DS DP U-690
5002953
DS DP U-691
Sep 17, 2011
5002953
Sep 17, 2011
DS DP U-734
5002953
Mar 17, 2012
5002953*PED
DS DP U-734
Apr 21, 2015
5741803
DS DP U-493
Apr 21, 2015
5741803
Oct 21, 2015
5741803*PED
U-493
Jun 19, 2016
5965584
U-493
Jun 19, 2016
6166042
U-493
Feb 11, 2017
6288095
Aug 11, 2017
6288095*PED
Apr 19, 2020
DS
7358366
Oct 19, 2020
7358366*PED

Y
Y

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET

DS DP U-690
N021410 002 5002953
Sep 17, 2011
5002953
Sep 17, 2011
DS DP U-691
Sep 17, 2011
DS DP U-734
5002953
DS DP U-493
Sep 17, 2011
5002953
Mar 17, 2012
5002953*PED
DS DP U-493
Apr 21, 2015
5741803
Apr 21, 2015
DS DP U-734
5741803
Oct 21, 2015
5741803*PED
Jun 19, 2016
U-493
5965584
U-493
Jun 19, 2016
6166042
U-493
Feb 11, 2017
6288095
Aug 11, 2017
6288095*PED
DS
Apr 19, 2020
7358366
Oct 19, 2020
7358366*PED

Y
Y

Y
Y
Y

Y
Y
Y

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 122 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET

DS DP U-493
N021410 003 5002953
Sep 17, 2011
Sep 17, 2011
DS DP U-691
5002953
DS DP U-690
Sep 17, 2011
5002953
Sep 17, 2011
DS DP U-734
5002953
Mar 17, 2012
5002953*PED
DS DP U-493
Apr 21, 2015
5741803
DS DP U-734
Apr 21, 2015
5741803
Oct 21, 2015
5741803*PED
U-493
Jun 19, 2016
5965584
U-493
Jun 19, 2016
6166042
U-493
Feb 11, 2017
6288095
Aug 11, 2017
6288095*PED
Apr 19, 2020
DS
7358366
Oct 19, 2020
7358366*PED
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
DS DP U-690
N021410 004 5002953
Sep 17, 2011
Sep 17, 2011
DS DP U-691
5002953
Sep 17, 2011
DS DP U-734
5002953
DS DP U-493
Sep 17, 2011
5002953
Mar 17, 2012
5002953*PED
DS DP U-493
Apr 21, 2015
5741803
DS DP U-734
Apr 21, 2015
5741803
Oct 21, 2015
5741803*PED
DS
Apr 19, 2020
7358366
Oct 19, 2020
7358366*PED
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N021410 005 5002953
Sep 17, 2011
DS DP U-493
DS DP U-691
5002953
Sep 17, 2011
Sep 17, 2011
DS DP U-690
5002953
DS DP U-734
Sep 17, 2011
5002953
Mar 17, 2012
5002953*PED
DS DP U-493
Apr 21, 2015
5741803
DS DP U-734
Apr 21, 2015
5741803
Oct 21, 2015
5741803*PED
DS
Apr 19, 2020
7358366
Oct 19, 2020
7358366*PED

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

Y
Y
Y
Y
Y

Y
Y

Y
Y

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN - KOMBIGLYZE XR

N200678 001 6395767
Feb 16, 2021
DS DP

U-1097

NCE

Jul

31, 2014

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN - KOMBIGLYZE XR

DS DP
N200678 002 6395767
Feb 16, 2021

U-1097

NCE

Jul

31, 2014

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN - KOMBIGLYZE XR

DS DP
N200678 003 6395767
Feb 16, 2021

U-1097

NCE

Jul

31, 2014

NCE

Oct

16, 2011

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET

U-802
N022044 001 6303661
Apr 24, 2017
DS DP U-802
6699871
Jul 26, 2022
U-803
6890898
Feb 02, 2019
U-1036
6890898
Feb 02, 2019
U-1038
6890898
Feb 02, 2019
U-803
7078381
Feb 02, 2019
U-1038
7078381
Feb 02, 2019
U-1036
7078381
Feb 02, 2019
DP U-1038
7125873
Jul 26, 2022
DP U-1036
7125873
Jul 26, 2022
DP U-803
7125873
Jul 26, 2022
DS DP U-802
7326708
Apr 11, 2026

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 123 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET

U-802
N022044 002 6303661
Apr 24, 2017
DS DP U-802
6699871
Jul 26, 2022
U-803
6890898
Feb 02, 2019
U-1038
6890898
Feb 02, 2019
6890898
Feb 02, 2019
U-1036
U-1038
7078381
Feb 02, 2019
U-1036
7078381
Feb 02, 2019
U-803
7078381
Feb 02, 2019
DP U-1036
7125873
Jul 26, 2022
7125873
Jul 26, 2022
DP U-1038
DP U-803
7125873
Jul 26, 2022
DS DP U-802
7326708
Apr 11, 2026

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Oct

16, 2011

METHYL AMINOLEVULINATE HYDROCHLORIDE - METVIXIA

N021415 001 6034267
Mar 08, 2016

U-804

METHYLNALTREXONE BROMIDE - RELISTOR

N021964 001 6559158
Nov 03, 2017

U-1185

NCE

Apr

24, 2013

METHYLNALTREXONE BROMIDE - RELISTOR

N021964 002 6559158
Nov 03, 2017

U-1185

NCE

Apr

24, 2013

NPP

Jun

29, 2013

NPP

Jun

29, 2013

NPP

Jun

29, 2013

NPP

Jun

29, 2013

M-88

Nov

04, 2012

M-88

Nov

04, 2012

M-88

Nov

04, 2012

M-88

Nov

04, 2012

METHYLPHENIDATE - DAYTRANA
N021514 001 5958446
6210705
6348211

Dec
Sep
Sep

12, 2012
30, 2018
30, 2018

DP
DP
DP

U-727
U-727

METHYLPHENIDATE - DAYTRANA
N021514 002 5958446
6210705
6348211

Dec
Sep
Sep

12, 2012
30, 2018
30, 2018

DP
DP
DP

U-727
U-727

METHYLPHENIDATE - DAYTRANA
N021514 003 5958446
6210705
6348211

Dec
Sep
Sep

12, 2012
30, 2018
30, 2018

DP
DP
DP

U-727
U-727

METHYLPHENIDATE - DAYTRANA
N021514 004 5958446
6210705
6348211

Dec
Sep
Sep

12, 2012
30, 2018
30, 2018

DP
DP
DP

U-727
U-727

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA

N021121 001 6919373
Jul 31, 2017
6919373*PED
Jan 31, 2018
6930129
Jul 31, 2017
6930129*PED
Jan 31, 2018

U-666
U-666

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA

N021121 002 6919373
Jul 31, 2017
6919373*PED
Jan 31, 2018
6930129
Jul 31, 2017
6930129*PED
Jan 31, 2018

U-666
U-666

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA

N021121 003 6919373
Jul 31, 2017
6919373*PED
Jan 31, 2018
6930129
Jul 31, 2017
6930129*PED
Jan 31, 2018

U-666
U-666

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA

N021121 004 6919373
Jul 31, 2017
6919373*PED
Jan 31, 2018
6930129
Jul 31, 2017
6930129*PED
Jan 31, 2018
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N021259 001 6344215
Oct 27, 2020

U-666
U-666

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 124 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

METHYLPHENIDATE HYDROCHLORIDE - METADATE CD

N021259 002 6344215
Oct 27, 2020

DP

METHYLPHENIDATE HYDROCHLORIDE - METADATE CD

N021259 003 6344215
Oct 27, 2020

DP

METHYLPHENIDATE HYDROCHLORIDE - METADATE CD

N021259 004 6344215
Oct 27, 2020

DP

METHYLPHENIDATE HYDROCHLORIDE - METHYLIN

N021419 001 7691880
Oct 07, 2024

DP

METHYLPHENIDATE HYDROCHLORIDE - METHYLIN

N021419 002 7691880
Oct 07, 2024

DP

METHYLPHENIDATE HYDROCHLORIDE - RITALIN

N021284 001 5837284
Dec 04,
6228398
Nov 01,
6635284
Dec 04,
7431944
Dec 04,

LA
2015
2019
2015
2015

DP
DP
DP
DP

U-472
U-591

METHYLPHENIDATE HYDROCHLORIDE - RITALIN

N021284 002 5837284
Dec 04,
6228398
Nov 01,
6635284
Dec 04,
7431944
Dec 04,

LA
2015
2019
2015
2015

DP
DP
DP
DP

U-472
U-591

METHYLPHENIDATE HYDROCHLORIDE - RITALIN

N021284 003 5837284
Dec 04,
6228398
Nov 01,
6635284
Dec 04,
7431944
Dec 04,

LA
2015
2019
2015
2015

DP
DP
DP
DP

U-472
U-591

METHYLPHENIDATE HYDROCHLORIDE - RITALIN

N021284 004 5837284
Dec 04,
6228398
Nov 01,
6635284
Dec 04,
7431944
Dec 04,

LA
2015
2019
2015
2015

DP
DP
DP
DP

U-472
U-591

METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT

N022246 001 6413549
Jul 11, 2017

DP

METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT

N022246 002 6413549
Jul 11, 2017

DP

METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT

Apr 09, 2018
N021793 001 6024981
Apr 09, 2018
6221392

DP
DP

METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT

N021793 002 6024981
Apr 09, 2018
6221392
Apr 09, 2018

DP
DP

METRONIDAZOLE - FLAGYL ER
N020868 001 6103262

Aug

15, 2017

DP

U-137

METRONIDAZOLE - METROGEL
N021789 001 6881726
7348317

Feb
Feb

21, 2022
21, 2022

DP
DP

U-743
U-743

METRONIDAZOLE - METROGEL-VAGINAL
N020208 001 5536743
Jul

16, 2013

METRONIDAZOLE - VANDAZOLE
N021806 001 7456207

22, 2024

Sep

U-137

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 125 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

MICAFUNGIN SODIUM - MYCAMINE

N021506 002 5376634
6107458
6107458
6265536
6265536
6774104
6774104

Dec
Mar
Mar
Sep
Sep
Jan
Jan

27,
16,
16,
29,
29,
08,
08,

2011
2019
2019
2015
2015
2021
2021

DS
DS
DS
DS
DS

DP
DP
DP
DP
DP
DP
DP

U-650
U-845
U-650
U-845
U-845
U-650

MICAFUNGIN SODIUM - MYCAMINE

N021506 003 5376634
6107458
6107458
6265536
6265536
6774104
6774104

Dec
Mar
Mar
Sep
Sep
Jan
Jan

27,
16,
16,
29,
29,
08,
08,

2011
2019
2019
2015
2015
2021
2021

DS
DS
DS
DS
DS

DP
DP
DP
DP
DP
DP
DP

U-845
U-650
U-845
U-650
U-845
U-650

MICONAZOLE - ORAVIG
N022404 001 6916485
7651698

Sep
Jan

11, 2022
08, 2026

DP

U-1051
U-1051

MICONAZOLE NITRATE - MONISTAT 1 COMBINATION PACK

N021308 001 5514698
Mar 21, 2014
6153635
Nov 28, 2020
MIGLUSTAT - ZAVESCA
N021348 001 5472969
5525616

May
Jun

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NDF

Apr

16, 2013

Y
Y

13, 2013
11, 2013

MILNACIPRAN HYDROCHLORIDE - SAVELLA

N022256 001 6602911
Nov 05, 2021
6992110
Nov 05, 2021
7888342
Nov 05, 2021
7994220
Sep 19, 2029

U-882
U-882
U-882
U-819

NCE

Jan

14, 2014

MILNACIPRAN HYDROCHLORIDE - SAVELLA

N022256 002 6602911
Nov 05, 2021
6992110
Nov 05, 2021
7888342
Nov 05, 2021
7994220
Sep 19, 2029

U-882
U-882
U-882
U-819

NCE

Jan

14, 2014

MILNACIPRAN HYDROCHLORIDE - SAVELLA

N022256 003 6602911
Nov 05, 2021
6992110
Nov 05, 2021
7888342
Nov 05, 2021
7994220
Sep 19, 2029

U-882
U-882
U-882
U-819

NCE

Jan

14, 2014

MILNACIPRAN HYDROCHLORIDE - SAVELLA

N022256 004 6602911
Nov 05, 2021
6992110
Nov 05, 2021
7888342
Nov 05, 2021
7994220
Sep 19, 2029

U-882
U-882
U-882
U-819

NCE

Jan

14, 2014

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 001 5908838
Feb 19, 2018
7790705
Jun 24, 2025
7919483
Mar 07, 2027

U-917
U-1078
U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 002 5908838
Feb 19, 2018
7541347
Apr 02, 2027
Apr 02, 2027
7544373
Jun 24, 2025
7790705
Mar 07, 2027
7919483
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N050808 003 5908838
Feb 19, 2018
7790705
Jun 24, 2025
7919483
Mar 07, 2027

U-917
U-917
DP
U-1078
U-1078

U-917
U-1078
U-1078

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 126 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 004 5908838
Feb 19, 2018
7790705
Jun 24, 2025
7919483
Mar 07, 2027

U-917
U-1078
U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 005 5908838
Feb 19, 2018
7790705
Jun 24, 2025
7919483
Mar 07, 2027

U-917
U-1078
U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 006 5908838
Feb 19, 2018
7790705
Jun 24, 2025
7919483
Mar 07, 2027

U-917
U-1078
U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 007 5908838
Feb 19, 2018
7790705
Jun 24, 2025
7919483
Mar 07, 2027

U-917
U-1078
U-1078

MINOCYCLINE HYDROCHLORIDE - SOLODYN

N050808 008 5908838
Feb 19, 2018
7790705
Jun 24, 2025
7919483
Mar 07, 2027

U-917
U-1078
U-1078

MINOXIDIL - MEN'S ROGAINE

N021812 001 6946120

Apr

20, 2019

DP

MODAFINIL - PROVIGIL
N020717 001 7297346
7297346*PED
RE37516
RE37516*PED

Nov
May
Oct
Apr

29,
29,
06,
06,

2023
2024
2014
2015

DP

MODAFINIL - PROVIGIL
N020717 002 7297346
7297346*PED
RE37516
RE37516*PED

Nov
May
Oct
Apr

29,
29,
06,
06,

2023
2024
2014
2015

DP

MOMETASONE FUROATE - ASMANEX TWISTHALER

N021067 001 5394868
Jun 25, 2012
5394868*PED
Dec 25, 2012
5687710
Nov 18, 2014
5687710*PED
May 18, 2015
5829434
Nov 03, 2015
5829434*PED
May 03, 2016
5889015
Jan 27, 2014
5889015*PED
Jul 27, 2014
6057307
Jan 27, 2014
6057307*PED
Jul 27, 2014
6240918
Feb 20, 2017
6240918*PED
Aug 20, 2017
6365581
Jan 27, 2014
6365581*PED
Jul 27, 2014
6503537
Mar 17, 2018
6503537*PED
Sep 17, 2018
6677322
Jan 27, 2014
6677322*PED
Jul 27, 2014
6949532
Jan 27, 2014
6949532*PED
Jul 27, 2014

U-702

U-255

U-255

DP
DP
DP
U-645
DP

U-645

DP
U-645
DP
U-645
U-645

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 127 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

MOMETASONE FUROATE - ASMANEX TWISTHALER

Jun 25, 2012
N021067 002 5394868
Dec 25, 2012
5394868*PED
Nov 18, 2014
5687710
May 18, 2015
5687710*PED
Nov 03, 2015
5829434
May 03, 2016
5829434*PED
Jan 27, 2014
5889015
Jul 27, 2014
5889015*PED
Jan 27, 2014
6057307
Jul 27, 2014
6057307*PED
Feb 20, 2017
6240918
Aug 20, 2017
6240918*PED
Jan 27, 2014
6365581
Jul 27, 2014
6365581*PED
Mar 17, 2018
6503537
Sep 17, 2018
6503537*PED
Jan 27, 2014
6677322
Jul 27, 2014
6677322*PED
Jan 27, 2014
6949532
Jul 27, 2014
6949532*PED

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP
DP
U-645
DP

U-645

DP
U-645
DP
U-645
U-645

MOMETASONE FUROATE MONOHYDRATE

N020762 001 5837699
5837699*PED
6127353
6127353*PED
6723713
6723713*PED

- NASONEX
Jan 27, 2014
Jul 27, 2014
Oct 03, 2017
Apr 03, 2018
Jan 27, 2014
Jul 27, 2014

MONTELUKAST SODIUM - SINGULAIR

N020829 002 5565473
5565473
5565473
5565473*PED

Feb
Feb
Feb
Aug

03,
03,
03,
03,

2012
2012
2012
2012

DS
DS
DS

DP
DP
DP

U-807
U-228
U-675
U-228

MONTELUKAST SODIUM - SINGULAIR

N020830 001 5565473
5565473
5565473
5565473*PED

Feb
Feb
Feb
Aug

03,
03,
03,
03,

2012
2012
2012
2012

DS
DS
DS

DP
DP
DP

U-675
U-807
U-228
U-228

MONTELUKAST SODIUM - SINGULAIR

N020830 002 5565473
5565473
5565473
5565473*PED

Feb
Feb
Feb
Aug

03,
03,
03,
03,

2012
2012
2012
2012

DS
DS
DS

DP
DP
DP

U-228
U-675
U-807
U-228

MONTELUKAST SODIUM - SINGULAIR

N021409 001 5565473
5565473
5565473*PED
8007830

Feb
Feb
Aug
Oct

03,
03,
03,
24,

2012
2012
2012
2022

DS
DS

DP
DP

U-675
U-807

MORPHINE SULFATE - AVINZA

N021260 001 6066339

Nov

25, 2017

MORPHINE SULFATE - AVINZA

N021260 002 6066339

Nov

25, 2017

MORPHINE SULFATE - AVINZA

N021260 003 6066339

Nov

25, 2017

MORPHINE SULFATE - AVINZA

N021260 004 6066339

Nov

25, 2017

MORPHINE SULFATE - AVINZA

N021260 005 6066339

Nov

25, 2017

DP
DS

U-625

DP
U-625

DP

DP

I-626
M-99

May
Jan

26, 2013
19, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 128 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

MORPHINE SULFATE - AVINZA

N021260 006 6066339

Nov

25, 2017

DP

MORPHINE SULFATE - DEPODUR

N021671 001 5723147
5807572
5891467
5931809
5962016
5997899
6171613
6193998
6241999

Mar
Sep
Jan
Jul
Jan
Sep
Oct
Sep
Sep

03,
15,
31,
14,
31,
01,
01,
01,
01,

2015
2015
2017
2015
2017
2016
2016
2016
2016

DP
DP
DP

MORPHINE SULFATE - DEPODUR

N021671 002 5723147
5807572
5891467
5931809
5962016
5997899
6171613
6193998
6241999

Mar
Sep
Jan
Jul
Jan
Sep
Oct
Sep
Sep

03,
15,
31,
14,
31,
01,
01,
01,
01,

2015
2015
2017
2015
2017
2016
2016
2016
2016

DP
DP
DP

MORPHINE SULFATE - DEPODUR

N021671 003 5723147
5807572
5891467
5931809
5962016
5997899
6171613
6193998
6241999

Mar
Sep
Jan
Jul
Jan
Sep
Oct
Sep
Sep

03,
15,
31,
14,
31,
01,
01,
01,
01,

2015
2015
2017
2015
2017
2016
2016
2016
2016

DP
DP
DP

DP
DP
DP
DP
DP

DP
DP
DP
DP
DP

DP
DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-584

U-584
U-584

U-584

U-584
U-584

U-584

U-584
U-584

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 001 7682633
Jun 19, 2027
7682634
Jun 19, 2027
DP
DP
7815934
Dec 12, 2027

U-443

NC

Aug

13, 2012

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 002 7682633
Jun 19, 2027
7682634
Jun 19, 2027
DP
DP
7815934
Dec 12, 2027

U-443

NC

Aug

13, 2012

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 003 7682633
Jun 19, 2027
DP
7682634
Jun 19, 2027
DP
7815934
Dec 12, 2027

U-443

NC

Aug

13, 2012

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 004 7682633
Jun 19, 2027
DP
7682634
Jun 19, 2027
DP
7815934
Dec 12, 2027

U-443

NC

Aug

13, 2012

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 005 7682633
Jun 19, 2027
DP
7682634
Jun 19, 2027
DP
7815934
Dec 12, 2027

U-443

NC

Aug

13, 2012

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA

N022321 006 7682633
Jun 19, 2027
DP
7682634
Jun 19, 2027
DP
7815934
Dec 12, 2027

U-443

NC

Aug

13, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 129 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

MOXIFLOXACIN HYDROCHLORIDE - AVELOX

N021085 001 4990517
Dec 08, 2011
5607942
Mar 04, 2014
5849752
Dec 05, 2016
6610327
Oct 29, 2019

PATENT
CODES
DS

DP

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-298
U-298
U-298
U-298

MOXIFLOXACIN HYDROCHLORIDE - AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

DS DP U-298
N021277 001 4990517
Dec 08, 2011
U-298
5607942
Mar 04, 2014
U-298
5849752
Dec 05, 2016
DP U-298
6548079
Jul 25, 2020
MOXIFLOXACIN HYDROCHLORIDE - MOXEZA
N022428 001 4990517
Dec 08, 2011
4990517*PED
Jun 08, 2012
5607942
Mar 04, 2014
5607942*PED
Sep 04, 2014
Sep 29, 2019
6716830
Mar 29, 2020
6716830*PED
Sep 29, 2019
7671070
Mar 29, 2020
7671070*PED
MOXIFLOXACIN HYDROCHLORIDE - VIGAMOX
N021598 001 4990517
Dec 08, 2011
4990517*PED
Jun 08, 2012
5607942
Mar 04, 2014
5607942*PED
Sep 04, 2014
Sep 29, 2019
6716830
Mar 29, 2020
6716830*PED
Sep 29, 2019
7671070
Mar 29, 2020
7671070*PED

DS

DP

U-709

DS

DP

U-709

DP
DP

U-709

DS

DP

U-709

DS

DP

U-709

DP
U-709

MUPIROCIN - CENTANY
N050788 001 6013657

Jul

08, 2018

DP

MUPIROCIN CALCIUM - BACTROBAN

N050746 001 6025389

Oct

20, 2014

DP

MYCOPHENOLATE MOFETIL - CELLCEPT

N050759 001 5688529
Nov

18, 2014

DP

U-1122

MYCOPHENOLATE MOFETIL HYDROCHLORIDE - CELLCEPT

N050758 001 5543408
Sep 15, 2013

DP

MYCOPHENOLIC ACID - MYFORTIC

N050791 001 6025391
6172107
6306900

Apr
Apr
Apr

10, 2017
10, 2017
10, 2017

DP
DP
DP

U-908
U-908

MYCOPHENOLIC ACID - MYFORTIC

N050791 002 6025391
6172107
6306900

Apr
Apr
Apr

10, 2017
10, 2017
10, 2017

DP
DP
DP

U-908
U-908

NP
PED

Nov
May

19, 2013
19, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 130 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

NALTREXONE - VIVITROL
N021897 001 5792477
5916598
6194006
6264987
6331317
6379703
6379704
6395304
6403114
6495164
6495166
6534092
6537586
6596316
6667061
6713090
6939033
7799345
7919499
7919499

May
May
Dec
May
Nov
Dec
May
Nov
May
May
Nov
May
Nov
Dec
May
Nov
Nov
May
Oct
Oct

02,
02,
30,
19,
12,
30,
19,
12,
02,
25,
12,
19,
12,
30,
25,
12,
12,
25,
15,
15,

NAPROXEN SODIUM - NAPRELAN

N020353 001 5637320

Jun

10, 2014

NAPROXEN SODIUM - NAPRELAN

N020353 002 5637320

Jun

10, 2014

NAPROXEN SODIUM - NAPRELAN

N020353 003 5637320

Jun

10, 2014

2017
2017
2018
2020
2019
2018
2020
2019
2017
2020
2019
2020
2019
2018
2020
2019
2019
2020
2029
2029

PATENT
CODES
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-631

Oct

12, 2013

NCE

Dec

17, 2012

NCE

Dec

17, 2012

NCE

Dec

17, 2012

NCE

Dec

17, 2012

U-1124
U-1123

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - TREXIMET

Aug 14, 2017
N021926 001 6060499
Aug 14, 2017
6586458
Oct 02, 2025
7332183
Aug 14, 2017
8022095

DP
DP
DP
DP

U-867
U-867
U-867
U-867

NATEGLINIDE - STARLIX
N021204 001 5463116
5488150
6559188
6641841
6844008
6878749

Oct
Jan
Sep
Nov
Nov
Sep

21,
30,
15,
14,
14,
15,

2012
2013
2020
2017
2017
2020

DP
DP
DP
DP

U-827
U-214
U-214

NATEGLINIDE - STARLIX
N021204 002 5463116
5488150
6559188
6641841
6844008
6878749

Oct
Jan
Sep
Nov
Nov
Sep

21,
30,
15,
14,
14,
15,

2012
2013
2020
2017
2017
2020

DP
DP
DP
DP

U-827
U-214
U-214

NEBIVOLOL HYDROCHLORIDE - BYSTOLIC

N021742 002 5759580
Jun
6545040
Dec

02, 2015
17, 2021

DP
DP

U-3

NEBIVOLOL HYDROCHLORIDE - BYSTOLIC

N021742 003 5759580
Jun
6545040
Dec

02, 2015
17, 2021

DP
DP

U-3

NEBIVOLOL HYDROCHLORIDE - BYSTOLIC

N021742 004 5759580
Jun
6545040
Dec

02, 2015
17, 2021

DP
DP

U-3

NEBIVOLOL HYDROCHLORIDE - BYSTOLIC

N021742 005 5759580
Jun
6545040
Dec

02, 2015
17, 2021

DP
DP

U-3

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 131 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

NEDOCROMIL SODIUM - ALOCRIL

N021009 001 RE38628

Aug

22, 2012

NELARABINE - ARRANON
N021877 001 5424295
5492897
5747472
5747472
5747472
5821236

Jun
Feb
Feb
Feb
Feb
Feb

13,
20,
20,
20,
20,
20,

2017
2013
2013
2013
2013
2013

NELFINAVIR MESYLATE - VIRACEPT

N020778 001 5484926
5484926*PED
5952343
5952343*PED
6162812
6162812*PED

Oct
Apr
Oct
Apr
Oct
Apr

07,
07,
07,
07,
07,
07,

2013
2014
2013
2014
2013
2014

U-257
U-257
U-248
U-248

NELFINAVIR MESYLATE - VIRACEPT

N020779 001 5484926
5484926*PED
5952343
5952343*PED
6162812
6162812*PED

Oct
Apr
Oct
Apr
Oct
Apr

07,
07,
07,
07,
07,
07,

2013
2014
2013
2014
2013
2014

U-257
U-257
U-248
U-248

NELFINAVIR MESYLATE - VIRACEPT

N021503 001 5484926
5484926*PED
5952343
5952343*PED
6162812
6162812*PED

Oct
Apr
Oct
Apr
Oct
Apr

07,
07,
07,
07,
07,
07,

2013

2014

2013
2014
2013
2014

U-257
U-257
U-248
U-248

NEPAFENAC - NEVANAC
N021862 001 5475034
7834059
8071648

Jun
Jan
Dec

06, 2014
31, 2027
02, 2025

NESIRITIDE RECOMBINANT - NATRECOR

N020920 001 5114923
May

19, 2014

NEVIRAPINE - VIRAMUNE
N020636 001 5366972
5366972*PED

Nov
May

22, 2011
22, 2012

NEVIRAPINE - VIRAMUNE
N020933 001 5366972
5366972*PED

Nov
May

22, 2011
22, 2012

NEVIRAPINE - VIRAMUNE XR
N201152 001 5366972
5366972*PED

Nov
May

22, 2011
22, 2012

NIACIN - NIASPAN
N020381 001 6080428
6129930
6406715
6746691
6818229
7011848

May
Sep
Sep
Sep
Feb
Sep

27,
20,
20,
20,
15,
20,

2017
2013
2013
2013
2014
2013

PATENT
DELIST
REQUESTED

PATENT
CODES

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-304

DS

DP

ODE

Oct

28, 2012

NDF

Mar

25, 2014

U-689
U-695
U-696
U-689
U-695

U-100
U-1095
DP

DS

DP

U-855

U-167

DS

DP

U-167

U-331
U-354
U-450
U-586
DP
U-712

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 132 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

NIACIN - NIASPAN
N020381 002 6080428
6080428
6080428
6080428
6080428
6129930
6129930
6129930
6129930
6129930
6406715
6469035
6469035
6469035
6469035
6469035
6676967
6676967
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7011848
7011848
7998506
7998506
7998506
7998506

May
May
May
May
May
Sep
Sep
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
27,
27,
20,
20,
20,
20,
20,
20,
15,
15,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2017
2017
2017
2017
2017
2013
2013
2013
2013
2013
2013
2018
2018
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

NIACIN - NIASPAN
N020381 003 6080428
6080428
6080428
6080428
6080428
6129930
6129930
6129930
6129930
6129930
6406715
6469035
6469035
6469035
6469035
6469035
6676967
6676967
6676967
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7011848
7011848
7998506
7998506
7998506
7998506

May
May
May
May
May
Sep
Sep
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
27,
27,
20,
20,
20,
20,
20,
20,
15,
15,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2017
2017
2017
2017
2017
2013
2013
2013
2013
2013
2013
2018
2018
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

PATENT
CODES

DP
DP
DP
DP
DP
DP

DP
DP

U-1138
U-1139
U-1140
U-331
U-1141
U-1141
U-1140
U-1138
U-354
U-1139
U-450
U-1142
U-1145
U-768
U-1144
U-1143
U-1139
U-1140
U-1138
U-548
U-1146
U-586
U-1148
U-712
U-1147
U-1140
U-1141
U-1140
U-1138
U-1141
U-1139

DP
DP
DP
DP
DP
DP

DP
DP

U-1140
U-1138
U-331
U-1139
U-1141
U-354
U-1138
U-1141
U-1139
U-1140
U-450
U-1144
U-768
U-1145
U-1143
U-1142
U-1140
U-1141
U-1146
U-1138
U-548
U-1139
U-586
U-1148
U-712
U-1147
U-1140
U-1141
U-1138
U-1140
U-1139
U-1141

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 133 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

NIACIN - NIASPAN
N020381 004 6080428
6080428
6080428
6080428
6080428
6129930
6129930
6129930
6129930
6129930
6406715
6469035
6469035
6469035
6469035
6469035
6676967
6676967
6676967
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7011848
7011848
7998506
7998506
7998506
7998506

PATENT
EXPIRATION
DATE

May
May
May
May
May
Sep
Sep
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
27,
27,
20,
20,
20,
20,
20,
20,
15,
15,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2017
2017
2017
2017
2017
2013
2013
2013
2013
2013
2013
2018
2018
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

PATENT
CODES

DP
DP
DP
DP
DP
DP

DP
DP

U-1147
U-1148
U-1141
U-1140
U-712
U-1140
U-1139
U-1141
U-1138

NIACIN - NIASPAN TITRATION STARTER PACK

N020381 005 6080428
May 27, 2017
6129930
Sep 20, 2013
6406715
Sep 20, 2013
6746691
Sep 20, 2013
7011848
Sep 20, 2013
NIACIN; SIMVASTATIN - SIMCOR
N022078 001 6080428
6080428
6080428
6129930
6129930
6129930
6406715
6469035
6469035
6469035
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7998506
7998506

May
May
May
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
20,
20,
20,
20,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2017
2017
2017
2013
2013
2013
2013
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

U-1140
U-331
U-1141
U-1139
U-1138
U-1139
U-354
U-1138
U-1141
U-1140
U-450
U-1143
U-768
U-1144
U-1145
U-1142
U-1140
U-548
U-1141
U-1138
U-1139
U-1146
U-586

U-331
U-354
U-450
U-586
U-712

DP
DP
DP
DP

U-1134
U-1132
U-862
U-1132
U-862
U-1134
U-1149
U-863
U-1129
U-1132
U-1134
U-862

DP
DP
U-862
U-1150
U-1151
U-1151
U-1150

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 134 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

NIACIN; SIMVASTATIN - SIMCOR

N022078 002 6080428
6080428
6080428
6129930
6129930
6129930
6406715
6469035
6469035
6469035
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7998506
7998506

May
May
May
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
20,
20,
20,
20,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2017
2017
2017
2013
2013
2013
2013
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

NIACIN; SIMVASTATIN - SIMCOR

N022078 003 6080428
6080428
6080428
6129930
6129930
6129930
6406715
6469035
6469035
6469035
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7998506
7998506

May
May
May
Sep
Sep
Sep
Sep
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
20,
20,
20,
20,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2017
2017
2017
2013
2013
2013
2013
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

NIACIN; SIMVASTATIN - SIMCOR

N022078 004 6080428
6080428
6080428
6129930
6406715
6469035
6469035
6469035
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7998506
7998506

May
May
May
Sep
Sep
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
20,
20,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

2017
2017
2017
2013
2013
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

PATENT
CODES

DP
DP
DP
DP

U-1134
U-1132
U-862
U-862
U-1134
U-1132
U-1129
U-863
U-1149
U-1132
U-1134
U-862

DP
DP
U-1150
U-862
U-1151
U-1150
U-1151

DP
DP
DP
DP

U-862
U-1132
U-1134
U-1132
U-862
U-1134
U-1149
U-1129
U-863
U-1132
U-1134
U-862

DP
DP
U-862
U-1151
U-1150
U-1150
U-1151

DP
DP

U-1132
U-862
U-1134
U-862
U-863
U-1129
U-1149
U-1132
U-1134
U-862

DP
DP
U-862
U-1151
U-1150
U-1151
U-1150

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 135 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

NIACIN; SIMVASTATIN - SIMCOR

N022078 005 6080428
6080428
6080428
6129930
6406715
6469035
6469035
6469035
6676967
6676967
6676967
6746691
6818229
7011848
7011848
7011848
7998506
7998506

PATENT
EXPIRATION
DATE

May
May
May
Sep
Sep
Mar
Mar
Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

27,
27,
27,
20,
20,
15,
15,
15,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,

PATENT
CODES

2017
2017
2017
2013
2013
2018
2018
2018
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-862
U-1134
U-1132
U-862
U-1149
U-863
U-1129
U-1134
U-1132
U-862

DP
DP
U-1150
U-862
U-1151
U-1151
U-1150

NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

N019734 004 7612102
Dec 26, 2027
DP
U-1029
7659291
Apr 18, 2027
NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
N019734 003 7612102
Dec 26, 2027
DP
U-1029
7659291
Apr 18, 2027
NICARDIPINE HYDROCHLORIDE - CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
N019734 002 7612102
Dec 26, 2027
DP
U-1029
7659291
Apr 18, 2027
NICARDIPINE HYDROCHLORIDE - CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
N019734 005 7612102
Dec 26, 2027
DP
U-1029
7659291
Apr 18, 2027
NICOTINE - NICODERM CQ
N020165 004 5508038

Apr

16, 2013

NICOTINE - NICODERM CQ
N020165 005 5508038

Apr

16, 2013

NICOTINE - NICODERM CQ
N020165 006 5508038

Apr

16, 2013

NICOTINE - NICOTROL
N020385 001 5656255

Aug

12, 2014

NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA

N022068 001 7169791
Jul 04, 2023

DS

DP

U-836

I-627
NCE
ODE

Jun
Oct
Oct

17, 2013
29, 2012
29, 2014

NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA

N022068 002 7169791
Jul 04, 2023

DS

DP

U-836

I-627
NCE
ODE

Jun
Oct
Oct

17, 2014
29, 2012
29, 2014

NISOLDIPINE - SULAR
N020356 005 5422123
5626874

Jun
Nov

06, 2012
30, 2014

DP
DP

NISOLDIPINE - SULAR
N020356 006 5422123
5626874

Jun
Nov

06, 2012
30, 2014

DP
DP

NISOLDIPINE - SULAR
N020356 007 5422123
5626874

Jun
Nov

06, 2012
30, 2014

DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 136 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

NISOLDIPINE - SULAR
N020356 008 5422123
5626874

Jun
Nov

06, 2012
30, 2014

DP
DP

NITAZOXANIDE - ALINIA
N021497 001 5387598
5578621
5968961
6020353

Feb
Nov
May
Sep

07,
26,
07,
18,

2012
2013
2017
2014

DP
DP
DP
DP

NITAZOXANIDE - ALINIA
N021498 001 5387598
5578621
5965590
5968961
6020353
6117894

Feb
Sep
Jul
May
Sep
May

07,
08,
03,
07,
08,
07,

2012
2014
2017
2017
2014
2017

NITISINONE - ORFADIN
N021232 001 5550165

Aug

27, 2013

NITISINONE - ORFADIN
N021232 002 5550165

Aug

27, 2013

NITISINONE - ORFADIN
N021232 003 5550165

Aug

27, 2013

NITRIC OXIDE - INOMAX

N020845 002 5485827
5485827*PED
5873359
5873359*PED

Jan
Jul
Jan
Jul

23,
23,
23,
23,

2013
2013
2013
2013

U-297

NITRIC OXIDE - INOMAX

N020845 003 5485827
5485827*PED
5873359
5873359*PED

Jan
Jul
Jan
Jul

23,
23,
23,
23,

2013
2013
2013
2013

U-297

NITROGLYCERIN - NITROMIST
N021780 001 5869082

Apr

16, 2016

NITROGLYCERIN - NITROSTAT
N021134 001 6500456

Sep

16, 2018

NITROGLYCERIN - NITROSTAT
N021134 002 6500456

Sep

16, 2018

NITROGLYCERIN - NITROSTAT
N021134 003 6500456

Sep

16, 2018

NITROGLYCERIN - RECTIV
N021359 001 7189761

May

27, 2014

DP

NIZATIDINE - AXID
N021494 001 6930119

Jul

17, 2022

DP

OCTREOTIDE ACETATE - SANDOSTATIN

May
N019667 001 5753618
Nov
5753618*PED

19, 2015
19, 2015

OCTREOTIDE ACETATE - SANDOSTATIN

May
N019667 002 5753618
Nov
5753618*PED

19, 2015
19, 2015

OCTREOTIDE ACETATE - SANDOSTATIN

May
N019667 003 5753618
Nov
5753618*PED

19, 2015
19, 2015

DS

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-524
U-525

U-524
U-525
U-523

U-297

U-297

DP

U-1198

NP

Jun

21, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 137 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

OCTREOTIDE ACETATE - SANDOSTATIN

N019667 004 5753618
May
Nov
5753618*PED

19, 2015
19, 2015

OCTREOTIDE ACETATE - SANDOSTATIN

May
N019667 005 5753618
Nov
5753618*PED

19, 2015
19, 2015

OCTREOTIDE ACETATE - SANDOSTATIN LAR

Jul 23,
N021008 001 5538739
Jan 23,
5538739*PED
Jun 17,
5639480
Dec 17,
5639480*PED
Nov 18,
5688530
May 18,
5688530*PED
Jul 13,
5922338
Jan 13,
5922338*PED
Jul 13,
5922682
Jan 13,
5922682*PED

2013
2014
2014
2014
2014
2015
2016
2017
2016
2017

OCTREOTIDE ACETATE - SANDOSTATIN LAR

N021008 002 5538739
Jul 23,
5538739*PED
Jan 23,
5639480
Jun 17,
5639480*PED
Dec 17,
5688530
Nov 18,
5688530*PED
May 18,
Jul 13,
5922338
Jan 13,
5922338*PED
Jul 13,
5922682
Jan 13,
5922682*PED

2013
2014
2014
2014
2014
2015
2016
2017
2016
2017

OCTREOTIDE ACETATE - SANDOSTATIN LAR

N021008 003 5538739
Jul 23,
5538739*PED
Jan 23,
5639480
Jun 17,
5639480*PED
Dec 17,
5688530
Nov 18,
5688530*PED
May 18,
Jul 13,
5922338
Jan 13,
5922338*PED
Jul 13,
5922682
Jan 13,
5922682*PED

2013
2014
2014
2014
2014
2015
2016
2017
2016
2017

OFLOXACIN - FLOXIN OTIC

N020799 001 5401741

Mar

27, 2012

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
DP
U-268
DP
DP

DP
U-268
DP
DP

DP
U-268
DP
DP

U-407

OLANZAPINE - OLANZAPINE
A076000 001

PC

Apr

21, 2012

OLANZAPINE - OLANZAPINE
A076000 002

PC

Apr

21, 2012

OLANZAPINE - OLANZAPINE
A076000 003

PC

Apr

21, 2012

OLANZAPINE - OLANZAPINE
A076000 004

PC

Apr

21, 2012

OLANZAPINE - OLANZAPINE
A076000 005

PC

Apr

21, 2012

OLANZAPINE - OLANZAPINE
A076133 002

PC

Apr

21, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 138 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

OLANZAPINE - ZYPREXA
N020592 001 5229382*PED
5605897
5605897*PED
5627178*PED
5736541
5736541*PED
5817655*PED
5817656*PED
5817657*PED
5919485
5919485*PED
6251895
6251895*PED
6960577

Oct
Feb
Aug
Oct
Mar
Sep
Oct
Oct
Oct
Mar
Sep
Sep
Mar
Nov

23,
25,
25,
23,
24,
24,
23,
23,
23,
24,
24,
23,
23,
01,

2011
2014
2014
2011
2015
2015
2011
2011
2011
2015
2015
2017
2018
2017

OLANZAPINE - ZYPREXA
N020592 002 5229382*PED
5605897
5605897*PED
5627178*PED
5736541
5736541*PED
5817655*PED
5817656*PED
5817657*PED
5919485
5919485*PED
6251895
6251895*PED
6960577

Oct
Feb
Aug
Oct
Mar
Sep
Oct
Oct
Oct
Mar
Sep
Sep
Mar
Nov

23,
25,
25,
23,
24,
24,
23,
23,
23,
24,
24,
23,
23,
01,

2011
2014
2014
2011
2015
2015
2011
2011
2011
2015
2015
2017
2018
2017

OLANZAPINE - ZYPREXA
N020592 003 5229382*PED
5605897
5605897*PED
5627178*PED
5736541
5736541*PED
5817655*PED
5817656*PED
5817657*PED
5919485
5919485*PED
6251895
6251895*PED
6960577

Oct
Feb
Aug
Oct
Mar
Sep
Oct
Oct
Oct
Mar
Sep
Sep
Mar
Nov

23,
25,
25,
23,
24,
24,
23,
23,
23,
24,
24,
23,
23,
01,

2011
2014
2014
2011
2015
2015
2011
2011
2011
2015
2015
2017
2018
2017

OLANZAPINE - ZYPREXA
N020592 004 5229382*PED
5605897
5605897*PED
5627178*PED
5736541
5736541*PED
5817655*PED
5817656*PED
5817657*PED
5919485
5919485*PED
6251895
6251895*PED
6960577

Oct
Feb
Aug
Oct
Mar
Sep
Oct
Oct
Oct
Mar
Sep
Sep
Mar
Nov

23,
25,
25,
23,
24,
24,
23,
23,
23,
24,
24,
23,
23,
01,

2011
2014
2014
2011
2015
2015
2011
2011
2011
2015
2015
2017
2018
2017

PATENT
CODES

U-176

U-307

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-591
NPP
NPP
PED
PED

Mar
Dec
Dec
Jun
Jun

19,
04,
04,
04,
04,

2012
2012
2012
2013
2013

I-591
NPP
NPP
PED
PED

Mar
Dec
Dec
Jun
Jun

19,
04,
04,
04,
04,

2012
2012
2012
2013
2013

I-591
NPP
NPP
PED
PED

Mar
Dec
Dec
Jun
Jun

19,
04,
04,
04,
04,

2012
2012
2012
2013
2013

I-591
NPP
NPP
PED
PED

Mar
Dec
Dec
Jun
Jun

19,
04,
04,
04,
04,

2012
2012
2012
2013
2013

U-308

U-963

U-176

U-307

U-308

U-963

U-176

U-307

U-308

U-963

U-176

U-307

U-308

U-963

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 139 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

OLANZAPINE - ZYPREXA
N020592 005 5229382*PED
5605897
5605897*PED
5627178*PED
5736541
5736541*PED
5817655*PED
5817656*PED
5817657*PED
5919485
5919485*PED
6251895
6251895*PED
6960577

Oct
Feb
Aug
Oct
Mar
Sep
Oct
Oct
Oct
Mar
Sep
Sep
Mar
Nov

23,
25,
25,
23,
24,
24,
23,
23,
23,
24,
24,
23,
23,
01,

2011
2014
2014
2011
2015
2015
2011
2011
2011
2015
2015
2017
2018
2017

OLANZAPINE - ZYPREXA
N020592 006 5229382*PED
5605897
5605897*PED
5627178*PED
5736541
5736541*PED
5817655*PED
5817656*PED
5817657*PED
5919485
5919485*PED
6251895
6251895*PED
6960577

Oct
Feb
Aug
Oct
Mar
Sep
Oct
Oct
Oct
Mar
Sep
Sep
Mar
Nov

23,
25,
25,
23,
24,
24,
23,
23,
23,
24,
24,
23,
23,
01,

2011
2014
2014
2011
2015
2015
2011
2011
2011
2015
2015
2017
2018
2017

OLANZAPINE - ZYPREXA
N021253 001 5229382*PED

Oct

23, 2011

OLANZAPINE - ZYPREXA ZYDIS

N021086 001 5229382*PED
6960577

Oct
Nov

23, 2011
01, 2017

U-964

OLANZAPINE - ZYPREXA ZYDIS

N021086 002 5229382*PED
6960577

Oct
Nov

23, 2011
01, 2017

U-964

OLANZAPINE - ZYPREXA ZYDIS

N021086 003 5229382*PED
6960577

Oct
Nov

23, 2011
01, 2017

U-964

OLANZAPINE - ZYPREXA ZYDIS

N021086 004 5229382*PED
6960577

Oct
Nov

23, 2011
01, 2017

U-964

OLANZAPINE PAMOATE - ZYPREXA RELPREVV

N022173 001 5229382*PED
Oct 23, 2011
6169084
Sep 30, 2018

U-176

U-307

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-591
NPP
NPP
PED
PED

Mar
Dec
Dec
Jun
Jun

19,
04,
04,
04,
04,

2012
2012
2012
2013
2013

I-591
NPP
NPP
PED
PED

Mar
Dec
Dec
Jun
Jun

19,
04,
04,
04,
04,

2012
2012
2012
2013
2013

I-591
NPP
NPP
PED
PED

Mar
Dec
Dec
Jun
Jun

19,
04,
04,
04,
04,

2012
2012
2012
2013
2013

I-591
NPP
NPP
PED
PED

Mar
Dec
Dec
Jun
Jun

19,
04,
04,
04,
04,

2012
2012
2012
2013
2013

I-591
NPP
NPP
PED
PED

Mar
Dec
Dec
Jun
Jun

19,
04,
04,
04,
04,

2012
2012
2012
2013
2013

I-591
NPP
NPP
PED
PED

Mar
Dec
Dec
Jun
Jun

19,
04,
04,
04,
04,

2012
2012
2012
2013
2013

NP

Dec

11, 2012

U-308

U-963

U-176

U-307

U-308

U-963

DS

DP

U-1026

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 140 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

OLANZAPINE PAMOATE - ZYPREXA RELPREVV

Oct 23, 2011
N022173 002 5229382*PED
Sep 30, 2018
6169084

DS

DP

U-1026

OLANZAPINE PAMOATE - ZYPREXA RELPREVV

Oct 23, 2011
N022173 003 5229382*PED
Sep 30, 2018
6169084

DS

DP

U-1026

DP

U-500

OLMESARTAN MEDOXOMIL - BENICAR

N021286 001 5616599
5616599*PED
6878703
6878703*PED

Apr
Oct
Nov
May

25,
25,
19,
19,

2016
2016
2021
2022

DS

OLMESARTAN MEDOXOMIL - BENICAR

N021286 003 5616599
5616599*PED
6878703
6878703*PED

Apr
Oct
Nov
May

25,
25,
19,
19,

2016
2016
2021
2022

DS

OLMESARTAN MEDOXOMIL - BENICAR

N021286 004 5616599
5616599*PED
6878703
6878703*PED

Apr
Oct
Nov
May

25,
25,
19,
19,

2016
2016
2021
2022

DS

U-3

DP

OLOPATADINE HYDROCHLORIDE - PATADAY

N021545 001 5641805
Jun 06, 2015
5641805*PED
Dec 06, 2015
6995186
Nov 12, 2023
6995186*PED
May 12, 2024
7402609
Jun 19, 2022
7402609*PED
Dec 19, 2022

DP

OMEPRAZOLE - PRILOSEC
N019810 001 6147103
6147103*PED
6150380
6150380*PED
6166213
6166213*PED
6191148
6191148*PED

Oct
Apr
Nov
May
Oct
Apr
Oct
Apr

09,
09,
10,
10,
09,
09,
09,
09,

2018
2019
2018
2019
2018
2019
2018
2019

OMEPRAZOLE - PRILOSEC
N019810 002 6147103
6147103*PED
6150380
6150380*PED
6166213
6166213*PED
6191148
6191148*PED

Oct
Apr
Nov
May
Oct
Apr
Oct
Apr

09,
09,
10,
10,
09,
09,
09,
09,

2018
2019
2018
2019
2018
2019
2018
2019

Dec

11, 2012

NP

Dec

11, 2012

NPP
PED

Feb
Aug

04, 2013
04, 2013

NPP
PED

Feb
Aug

04, 2013
04, 2013

NPP
PED

Feb
Aug

04, 2013
04, 2013

NPP
PED
PED

Dec
Jun
Oct

01, 2012
01, 2013
15, 2011

M-87

Sep

16, 2012

U-765

DP

DP
DP

OLOPATADINE HYDROCHLORIDE - PATANOL

N020688 001 5641805
Jun 06, 2015
5641805*PED
Dec 06, 2015

26, 2013
10, 2017
30, 2025

NP

U-765

OLOPATADINE HYDROCHLORIDE - PATANASE

Feb 02, 2023
N021861 001 7977376
Aug 02, 2023
7977376*PED

OMEGA-3-ACID ETHYL ESTERS - LOVAZA

N021654 001 5502077
Mar
5656667
Apr
Jan
7732488

EXCLUSIVITY
EXPIRATION
DATE

U-500
U-3

EXCLUSIVITY
CODE(S)

U-500
U-3

DP

PATENT
DELIST
REQUESTED

U-184

DS
DS
DS

DP
DP

U-822
U-822

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 141 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

OMEPRAZOLE - PRILOSEC
N019810 003 6147103
6147103*PED
6150380
6150380*PED
6166213
6166213*PED
6191148
6191148*PED

PATENT
EXPIRATION
DATE

Oct
Apr
Nov
May
Oct
Apr
Oct
Apr

09,
09,
10,
10,
09,
09,
09,
09,

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

2018
2019
2018
2019
2018
2019
2018
2019

OMEPRAZOLE MAGNESIUM - PRILOSEC

Nov
N022056 001 5690960
May
5900424
Nov
6428810

25, 2014
04, 2016
03, 2019

DS

OMEPRAZOLE MAGNESIUM - PRILOSEC

N022056 002 5690960
Nov
5900424
May
Nov
6428810

25, 2014
04, 2016
03, 2019

DS

OMEPRAZOLE MAGNESIUM - PRILOSEC OTC

N021229 001 5690960
Nov
5753265
Jun
5817338
Oct
5900424
May
Nov
6403616
Nov
6428810

25,
07,
06,
04,
15,
03,

DP
DP

DP
DP

U-864
U-864
U-864

PED

Sep

20, 2011

U-864
U-864
U-864

PED

Sep

20, 2011

2014
2015
2015
2016
2019
2019

OMEPRAZOLE; SODIUM BICARBONATE

N021636 001 5840737
6489346
6645988
6699885
6780882
7399772

- ZEGERID
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016

OMEPRAZOLE; SODIUM BICARBONATE

N021636 002 5840737
5840737
6489346
6489346
6645988
6699885
6699885
6780882
7399772
7399772

- ZEGERID
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

OMEPRAZOLE; SODIUM BICARBONATE

N021849 001 6489346
6645988
6699885
7399772

- ZEGERID
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016

DS
DS

OMEPRAZOLE; SODIUM BICARBONATE

N021849 002 6489346
6645988
6699885
7399772

- ZEGERID
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016
Jul 16, 2016

DS
DS

OMEPRAZOLE; SODIUM BICARBONATE

N022281 001 6489346
6645988
6699885
7399772

- ZEGERID OTC
Jul 15, 2016
Jul 15, 2016
Jul 15, 2016
Jul 15, 2016

DS
DS

DP
DP

DS

DP

U-588
U-588
U-588
U-588

DS
DS
DS

DP
DP
DP

U-624
U-623
U-624
U-623
U-623
U-624

DS

DP
U-623
U-624

DP
DP

U-588
U-588
U-588

DP
DP

U-623
U-623
U-623

DP
DP
DP

U-1025

U-1025

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 142 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ONDANSETRON - ZOFRAN ODT

N020781 001 5955488
5955488*PED
6063802
6063802*PED

Nov
May
Nov
May

14,
14,
14,
14,

2015
2016
2015
2016

ONDANSETRON - ZOFRAN ODT

N020781 002 5955488
5955488*PED
6063802
6063802*PED

Nov
May
Nov
May

14,
14,
14,
14,

2015
2016
2015
2016

PATENT
CODES

ONDANSETRON HYDROCHLORIDE - ZOFRAN

N020103 001 5344658
Sep
5344658*PED
Mar

06, 2011
06, 2012

ONDANSETRON HYDROCHLORIDE - ZOFRAN

N020103 002 5344658
Sep
5344658*PED
Mar

06, 2011
06, 2012

ONDANSETRON HYDROCHLORIDE - ZOFRAN

N020103 003 5344658
Sep
5344658*PED
Mar

06, 2011
06, 2012

ONDANSETRON HYDROCHLORIDE - ZOFRAN

Nov
N020605 001 5854270
May
5854270*PED

20, 2015
20, 2016

DP

ORLISTAT - ALLI
N021887 001 6004996

Jan

06, 2018

DP

ORLISTAT - XENICAL
N020766 001 6004996
6004996*PED

Jan
Jul

06, 2018
06, 2018

OSELTAMIVIR PHOSPHATE - TAMIFLU

N021087 001 5763483
Dec
5763483*PED
Jun
5866601
Feb
5866601*PED
Aug
5952375
Feb
5952375*PED
Aug

27,
27,
02,
02,
27,
27,

2016
2017
2016
2016
2015
2015

DS

OSELTAMIVIR PHOSPHATE - TAMIFLU

N021087 002 5763483
Dec
5763483*PED
Jun
5866601
Feb
5866601*PED
Aug
5952375
Feb
5952375*PED
Aug

27,
27,
02,
02,
27,
27,

2016
2017
2016
2016
2015
2015

DS

OSELTAMIVIR PHOSPHATE - TAMIFLU

N021087 003 5763483
Dec
5763483*PED
Jun
5866601
Feb
5866601*PED
Aug
5952375
Feb
5952375*PED
Aug

27,
27,
02,
02,
27,
27,

2016
2017
2016
2016
2015
2015

DS

OSELTAMIVIR PHOSPHATE - TAMIFLU

N021246 001 5763483
Dec
5763483
Dec
5763483*PED
Jun
5866601
Feb
5866601*PED
Aug
Feb
5952375
Aug
5952375*PED

27,
27,
27,
02,
02,
27,
27,

2016
2016
2017
2016
2016
2015
2015

DS
DS

DS

DP

DS

DP

DS

DP

DS

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-44

U-1113

M-90

Feb

22, 2013

U-1113

M-90

Feb

22, 2013

M-90

Feb

22, 2013

U-1113

DS

DP

DS

DP

U-376
U-1113

DS

DP

DS

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 143 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

OSELTAMIVIR PHOSPHATE - TAMIFLU

Dec
N021246 002 5763483
Jun
5763483*PED
Feb
5866601
Aug
5866601*PED
Feb
5952375
Aug
5952375*PED

27,
27,
02,
02,
27,
27,

2016
2017
2016
2016
2015
2015

DS

DP

DS

DP

DS

DP

OXALIPLATIN - ELOXATIN
N021492 001 5290961
5290961*PED
5338874
5338874*PED
5420319
5420319*PED

Jan
Jul
Apr
Oct
Aug
Feb

12,
12,
07,
07,
09,
09,

2013
2013
2013
2013
2016
2017

DS

OXALIPLATIN - ELOXATIN
N021492 002 5290961
5290961*PED
5338874
5338874*PED
5420319
5420319*PED

Jan
Jul
Apr
Oct
Aug
Feb

12,
12,
07,
07,
09,
09,

2013
2013
2013
2013
2016
2017

DS

OXALIPLATIN - ELOXATIN
N021759 001 5290961
5290961*PED
5338874
5338874*PED
5420319
5420319*PED
5716988
5716988*PED

Jan
Jul
Apr
Oct
Aug
Feb
Aug
Feb

12,
12,
07,
07,
09,
09,
07,
07,

2013
2013
2013
2013
2016
2017
2015
2016

DS

OXALIPLATIN - ELOXATIN
N021759 002 5290961
5290961*PED
5338874
5338874*PED
5420319
5420319*PED
5716988
5716988*PED

Jan
Jul
Apr
Oct
Aug
Feb
Aug
Feb

12,
12,
07,
07,
09,
09,
07,
07,

2013
2013
2013
2013
2016
2017
2015
2016

DS

OXALIPLATIN - ELOXATIN
N021759 003 5290961
5290961*PED
5338874
5338874*PED
5420319
5420319*PED
5716988
5716988*PED

Jan
Jul
Apr
Oct
Aug
Feb
Aug
Feb

12,
12,
07,
07,
09,
09,
07,
07,

2013
2013
2013
2013
2016
2017
2015
2016

DS

OXANDROLONE - OXANDRIN
N013718 001 5872147
6090799
6576659
6670351
6828313

Dec
Jul
Dec
Oct
Dec

05,
18,
05,
20,
05,

2017
2017
2017
2012
2017

U-585
U-585
U-585
U-585
U-585

OXANDROLONE - OXANDRIN
N013718 002 5872147
6090799
6576659
6670351
6828313

Dec
Jul
Dec
Oct
Dec

05,
18,
05,
20,
05,

2017
2017
2017
2012
2017

U-585
U-585
U-585
U-585
U-585

U-1113

DS
DS

DS
DS

DS
DS
DP

DS
DS
DP

DS
DS
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 144 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

OXCARBAZEPINE - TRILEPTAL
N021014 001 7037525
7037525*PED

Feb
Aug

12, 2018
12, 2018

U-724

OXCARBAZEPINE - TRILEPTAL
N021014 002 7037525
7037525*PED

Feb
Aug

12, 2018
12, 2018

U-724

OXCARBAZEPINE - TRILEPTAL
N021014 003 7037525
7037525*PED

Feb
Aug

12, 2018
12, 2018

U-724

OXCARBAZEPINE - TRILEPTAL
N021285 001 7037525
7037525*PED

Feb
Aug

12, 2018
12, 2018

U-724

OXYBUTYNIN - ANTUROL
N202513 001
OXYBUTYNIN - OXYTROL
N021351 002 5601839
5834010
6743441
7081249
7081250
7081251
7081252
7179483

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

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

2015
2015
2020
2020
2020
2020
2020
2020

OXYBUTYNIN CHLORIDE - DITROPAN

N020897 001 5674895
5674895*PED
5840754
5840754*PED
5912268
5912268*PED
6262115
6262115*PED

XL
May
Nov
May
Nov
May
Nov
May
Nov

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

2015
2015
2015
2015
2015
2015
2015
2015

U-393
U-393

OXYBUTYNIN CHLORIDE - DITROPAN

N020897 002 5674895
5674895*PED
5840754
5840754*PED
5912268
5912268*PED
6262115
6262115*PED

XL
May
Nov
May
Nov
May
Nov
May
Nov

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

2015
2015
2015
2015
2015
2015
2015
2015

U-393
U-393

OXYBUTYNIN CHLORIDE - DITROPAN

N020897 003 5674895
5674895*PED
5840754
5840754*PED
5912268
5912268*PED
6262115
6262115*PED

XL
May
Nov
May
Nov
May
Nov
May
Nov

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

2015
2015
2015
2015
2015
2015
2015
2015

U-393
U-393

DS

DP
DP
DP
DP
DP
DP

OXYBUTYNIN CHLORIDE - GELNIQUE

N022204 001 7029694
Apr
7179483
Apr

26, 2020
26, 2020

DP

OXYCODONE HYDROCHLORIDE - OXECTA

N202080 001 7201920
Mar
7510726
Nov
7981439
Nov

16, 2025
26, 2023
26, 2023

DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NP

Dec

07, 2014

NDF

Jan

27, 2012

U-318
U-318
U-318
U-318
U-318
U-318

U-318
U-318

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 145 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

OXYCODONE HYDROCHLORIDE - OXECTA

N202080 002 7201920
Mar
7510726
Nov
7981439
Nov

PATENT
CODES

16, 2025
26, 2023
26, 2023

DP
DP
DP

OXYCODONE HYDROCHLORIDE - OXYCONTIN

N020553 001 5508042
Apr 16, 2013
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Mar 30, 2025

DP

OXYCODONE HYDROCHLORIDE - OXYCONTIN

Apr 16, 2013
N020553 002 5508042
Mar 30, 2025
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 003 5508042
Apr 16, 2013
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Mar 30, 2025
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 004 5508042
Apr 16, 2013
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Mar 30, 2025
OXYCODONE HYDROCHLORIDE - OXYCONTIN
Apr 16, 2013
N020553 005 5508042
Mar 30, 2025
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 006 5508042
Apr 16, 2013
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Mar 30, 2025
OXYCODONE HYDROCHLORIDE - OXYCONTIN
Apr 16, 2013
N020553 007 5508042
Mar 30, 2025
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N020553 008 5508042
Apr 16, 2013
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Mar 30, 2025
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N022272 001 5508042
Apr 16, 2013
6488963
Jun 24, 2017
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Mar 30, 2025
7776314
Apr 19, 2025
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N022272 002 5508042
Apr 16, 2013
6488963
Jun 24, 2017
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Mar 30, 2025
7776314
Apr 19, 2025

U-443
DS
DS

U-443
DP
DS
DS

U-443
DP
DS
DS

U-443
DP
DS
DS

U-443
DP
DS
DS

U-443
DP
DS
DS

U-443
DP
DS
DS

U-443
DP
DS
DS

U-443
DP
DP
DS
DS
DP

U-443
DP
DP
DS
DS
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 146 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

OXYCODONE HYDROCHLORIDE - OXYCONTIN

Apr 16, 2013
N022272 003 5508042
Jun 24, 2017
6488963
Mar 30, 2025
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Apr 19, 2025
7776314
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N022272 004 5508042
Apr 16, 2013
6488963
Jun 24, 2017
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Mar 30, 2025
7776314
Apr 19, 2025
OXYCODONE HYDROCHLORIDE - OXYCONTIN
Apr 16, 2013
N022272 005 5508042
Jun 24, 2017
6488963
Mar 30, 2025
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Apr 19, 2025
7776314
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N022272 006 5508042
Apr 16, 2013
6488963
Jun 24, 2017
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Mar 30, 2025
7776314
Apr 19, 2025
OXYCODONE HYDROCHLORIDE - OXYCONTIN
Apr 16, 2013
N022272 007 5508042
Jun 24, 2017
6488963
Mar 30, 2025
7674799
Mar 30, 2025
7674800
Mar 30, 2025
7683072
Apr 19, 2025
7776314

PATENT
CODES
U-443
DP
DP
DS
DS
DP

U-443
DP
DP
DS
DS
DP

U-443
DP
DP
DS
DS
DP

U-443
DP
DP
DS
DS
DP

U-443
DP
DP
DS
DS
DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N021610 001 5662933
Sep 09, 2013
5958456
Sep 09, 2013
Feb 04, 2023
7276250

DP
DP
DP

U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

Sep 09, 2013
N021610 002 5662933
Sep 09, 2013
5958456
7276250
Feb 04, 2023

DP
DP
DP

U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

Sep 09, 2013
N021610 003 5662933
Sep 09, 2013
5958456
7276250
Feb 04, 2023

DP
DP
DP

U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

Sep 09, 2013
N021610 004 5662933
Sep 09, 2013
5958456
7276250
Feb 04, 2023

DP
DP
DP

U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

Sep 09, 2013
N021610 005 5662933
Sep 09, 2013
5958456
Feb 04, 2023
7276250

DP
DP
DP

U-826

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N021610 006 5662933
Sep 09, 2013
5958456
Sep 09, 2013
Feb 04, 2023
7276250

DP
DP
DP

U-826

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 147 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

OXYMORPHONE HYDROCHLORIDE - OPANA ER

Sep 09, 2013
N021610 007 5662933
Sep 09, 2013
5958456
Feb 04, 2023
7276250

DP
DP
DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 001 8075872
Nov 20, 2023

DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 002 8075872
Nov 20, 2023

DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 003 8075872
Nov 20, 2023

DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 004 8075872
Nov 20, 2023

DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 005 8075872
Nov 20, 2023

DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 006 8075872
Nov 20, 2023

DP

OXYMORPHONE HYDROCHLORIDE - OPANA ER

N201655 007 8075872
Nov 20, 2023

DP

PACLITAXEL - ABRAXANE
N021660 001 5439686
5498421
6096331
6506405
6537579
6749868
6753006
7820788
7923536
RE41884
PALIPERIDONE - INVEGA
N021999 001

PALIPERIDONE - INVEGA
N021999 002

Feb
Mar
Feb
Feb
Feb
Feb
Feb
Mar
Dec
Aug

22,
12,
22,
22,
22,
22,
22,
03,
09,
14,

2013
2013
2013
2013
2013
2013
2013
2024
2023
2016

DP
DP
DP
DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-826

U-634
U-633
U-633
U-632

U-1092
U-1117
U-1117

I-605
I-606
NPP
NCE
PED
PED
PED
PED

Jul
Jul
Apr
Dec
Oct
Jun
Jan
Jan

31,
31,
06,
19,
06,
19,
31,
31,

2012
2012
2014
2011
2014
2012
2013
2013

I-605
I-606
NPP
NCE
PED
PED
PED
PED

Jul
Jul
Apr
Dec
Oct
Jun
Jan
Jan

31,
31,
06,
19,
06,
19,
31,
31,

2012
2012
2014
2011
2014
2012
2013
2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 148 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PALIPERIDONE - INVEGA
N021999 003

PALIPERIDONE - INVEGA
N021999 004

PALIPERIDONE - INVEGA
N021999 006

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

Oct 27, 2012
N022264 001 5254556
Apr 27, 2013
5254556*PED
Dec 16, 2012
5352459
Jun 16, 2013
5352459*PED
May 12, 2017
6077843
Nov 12, 2017
6077843*PED
Nov 10, 2018
6555544
May 10, 2019
6555544*PED
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N022264 002 5254556
Oct 27, 2012
5254556*PED
Apr 27, 2013
Dec 16, 2012
5352459
Jun 16, 2013
5352459*PED
May 12, 2017
6077843
Nov 12, 2017
6077843*PED
Nov 10, 2018
6555544
May 10, 2019
6555544*PED
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
Oct 27, 2012
N022264 003 5254556
Apr 27, 2013
5254556*PED
Dec 16, 2012
5352459
Jun 16, 2013
5352459*PED
May 12, 2017
6077843
Nov 12, 2017
6077843*PED
Nov 10, 2018
6555544
May 10, 2019
6555544*PED
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
Oct 27, 2012
N022264 004 5254556
Apr 27, 2013
5254556*PED
Dec 16, 2012
5352459
Jun 16, 2013
5352459*PED
May 12, 2017
6077843
Nov 12, 2017
6077843*PED
Nov 10, 2018
6555544
May 10, 2019
6555544*PED

DS

DP

U-543

DP

DS

DP

U-543

DP

U-543

DP

U-543

DP

DS

DP

U-543

DP

U-543

DP

U-543

DP

DS

DP

U-543

DP

U-543

DP

U-543

DP
DP

U-543

DP

U-543

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-605
I-606
NPP
NCE
PED
PED
PED
PED

Jul
Jul
Apr
Dec
Oct
Jun
Jan
Jan

31,
31,
06,
19,
06,
19,
31,
31,

2012
2012
2014
2011
2014
2012
2013
2013

NPP
NCE
PED
PED

Apr
Dec
Oct
Jun

06,
19,
06,
19,

2014
2011
2014
2012

I-605
I-606
NPP
NCE
PED
PED
PED
PED

Jul
Jul
Apr
Dec
Oct
Jun
Jan
Jan

31,
31,
06,
19,
06,
19,
31,
31,

2012
2012
2014
2011
2014
2012
2013
2013

NDF
NCE
PED
PED

Jul
Dec
Jun
Jan

31,
19,
19,
31,

2012
2011
2012
2013

NDF
NCE
PED
PED

Jul
Dec
Jun
Jan

31,
19,
19,
31,

2012
2011
2012
2013

NDF
NCE
PED
PED

Jul
Dec
Jun
Jan

31,
19,
19,
31,

2012
2011
2012
2013

NDF
NCE
PED
PED

Jul
Dec
Jun
Jan

31,
19,
19,
31,

2012
2011
2012
2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 149 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PALIPERIDONE PALMITATE - INVEGA SUSTENNA

Oct 27, 2012
N022264 005 5254556
Apr 27, 2013
5254556*PED
Dec 16, 2012
5352459
Jun 16, 2013
5352459*PED
May 12, 2017
6077843
Nov 12, 2017
6077843*PED
Nov 10, 2018
6555544
May 10, 2019
6555544*PED

PATENT
CODES
DS

DP

U-543

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NDF
NCE
PED
PED

Jul
Dec
Jun
Jan

31,
19,
19,
31,

NDF

Aug

22, 2011

I-625
M-93
NCE

Apr
Jul
Apr

30, 2013
29, 2013
30, 2014

I-625
M-93
NCE

Apr
Jul
Apr

30, 2013
29, 2013
30, 2014

I-625
M-93
NCE

Apr
Jul
Apr

30, 2013
29, 2013
30, 2014

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE

N022523 001

NCE

Apr

12, 2015

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE

N022523 002

NCE

Apr

12, 2015

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE

N022523 003

NCE

Apr

12, 2015

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE

N022523 004

NCE

Apr

12, 2015

DP
DP

U-543

DP

U-543

PALONOSETRON HYDROCHLORIDE - ALOXI

N021372 001 5202333
Apr
7947724
Jan
7947725
Jan
7960424
Jan

13,
30,
30,
30,

2015
2024
2024
2024

DS

DP
DP
DP
DP

U-528

PALONOSETRON HYDROCHLORIDE - ALOXI

Apr
N021372 002 5202333
Jan
7947724
Jan
7947725
Jan
7960424

13,
30,
30,
30,

2015
2024
2024
2024

DS

DP
DP
DP
DP

U-901

PALONOSETRON HYDROCHLORIDE - ALOXI

N022233 001 5202333
Apr

13, 2015

DS

DP

U-528

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - CREON

N020725 001

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - CREON

N020725 002

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - CREON

N020725 003

2012
2011
2012
2013

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP

N022210 001 7658918
Feb 20, 2028

DP

NCE

Aug

27, 2014

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP

N022210 002 7658918
Feb 20, 2028

DP

NCE

Aug

27, 2014

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP

N022210 003 7658918
Feb 20, 2028

DP

NCE

Aug

27, 2014

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP

N022210 004 7658918
Feb 20, 2028

DP

NCE

Aug

27, 2014

I-614
M-54
PED
PED

Nov
Nov
May
May

12,
12,
12,
12,

PANTOPRAZOLE SODIUM - PROTONIX

N020987 001 5997903
Dec
5997903*PED
Jun

07, 2016
07, 2017

2012
2012
2013
2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 150 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PANTOPRAZOLE SODIUM - PROTONIX

N020987 002 5997903
Dec
5997903*PED
Jun

07, 2016
07, 2017

PANTOPRAZOLE SODIUM - PROTONIX

N022020 001 7544370
7544370*PED
7550153
7550153*PED
7553498
7553498*PED
7838027
7838027*PED

Jun
Dec
Sep
Mar
Sep
Mar
Sep
Mar

07,
07,
30,
30,
30,
30,
30,
30,

2026
2026
2024
2025
2024
2025
2024
2025

DP

PANTOPRAZOLE SODIUM - PROTONIX

N020988 001 6780881
6780881*PED
7351723
7351723*PED

IV
Nov
May
Nov
May

17,
17,
17,
17,

2021
2022
2021
2022

DP

PARICALCITOL - ZEMPLAR
N020819 001 5246925
5246925*PED
5587497
5587497*PED
5597815
5597815*PED
6136799
6136799*PED
6361758
6361758*PED

Apr
Oct
Dec
Jun
Jul
Jan
Apr
Oct
Apr
Oct

17,
17,
24,
24,
13,
13,
08,
08,
08,
08,

2012
2012
2013
2014
2015
2016
2018
2018
2018
2018

PARICALCITOL - ZEMPLAR
N020819 002 5246925
5246925*PED
5587497
5587497*PED
5597815
5597815*PED
6136799
6136799*PED
6361758
6361758*PED

Apr
Oct
Dec
Jun
Jul
Jan
Apr
Oct
Apr
Oct

17,
17,
24,
24,
13,
13,
08,
08,
08,
08,

2012
2012
2013
2014
2015
2016
2018
2018
2018
2018

PARICALCITOL - ZEMPLAR
N021606 001 5246925
5246925*PED
5587497
5587497*PED
5597815
5597815*PED

Apr
Oct
Dec
Jun
Jul
Jan

17,
17,
24,
24,
13,
13,

2012
2012
2013
2014
2015
2016

PARICALCITOL - ZEMPLAR
N021606 002 5246925
5246925*PED
5587497
5587497*PED
5597815
5597815*PED

Apr
Oct
Dec
Jun
Jul
Jan

17,
17,
24,
24,
13,
13,

2012
2012
2013
2014
2015
2016

PARICALCITOL - ZEMPLAR
N021606 003 5246925
5246925*PED
5587497
5587497*PED
5597815
5597815*PED

Apr
Oct
Dec
Jun
Jul
Jan

17,
17,
24,
24,
13,
13,

2012
2012
2013
2014
2015
2016

U-859
U-859
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-614
M-54
PED
PED

Nov
Nov
May
May

12,
12,
12,
12,

2012
2012
2013
2013

I-614
M-54
PED
PED

Nov
Nov
May
May

12,
12,
12,
12,

2012
2012
2013
2013

I-599

Jun

29, 2012

I-599

Jun

29, 2012

I-599

Jun

29, 2012

U-859

DP

U-314

U-1195

DP

U-314

U-1195

DP

U-671
DS
U-1195

U-671
DS
U-1195

U-671
DS
U-1195

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 151 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PAROXETINE HYDROCHLORIDE - PAROXETINE HYDROCHLORIDE

A091427 001

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)
PC

PAROXETINE HYDROCHLORIDE - PAXIL

N020031 001 5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6113944
Dec
6113944*PED
Jun
6121291
Mar
6121291
Mar
6121291*PED
Sep
6121291*PED
Sep
6133289
May
6133289*PED
Nov

19,
19,
19,
19,
14,
14,
17,
17,
17,
17,
19,
19,

2015
2015
2015
2015
2014
2015
2017
2017
2017
2017
2015
2015

U-286
U-431
U-431
U-286
U-358
U-358

PAROXETINE HYDROCHLORIDE - PAXIL

N020031 002 5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6113944
Dec
6113944*PED
Jun
6121291
Mar
6121291
Mar
6121291*PED
Sep
6121291*PED
Sep
6133289
May
6133289*PED
Nov

19,
19,
19,
19,
14,
14,
17,
17,
17,
17,
19,
19,

2015
2015
2015
2015
2014
2015
2017
2017
2017
2017
2015
2015

U-286
U-431
U-431
U-286
U-358
U-358

PAROXETINE HYDROCHLORIDE - PAXIL

N020031 003 5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6113944
Dec
6113944*PED
Jun
6121291
Mar
6121291
Mar
6121291*PED
Sep
6121291*PED
Sep
6133289
May
6133289*PED
Nov

19,
19,
19,
19,
14,
14,
17,
17,
17,
17,
19,
19,

2015
2015
2015
2015
2014
2015
2017
2017
2017
2017
2015
2015

U-286
U-431
U-431
U-286
U-358
U-358

PAROXETINE HYDROCHLORIDE - PAXIL

N020031 004 5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6113944
Dec
6113944*PED
Jun
6121291
Mar
6121291
Mar
6121291*PED
Sep
6121291*PED
Sep
6133289
May
6133289*PED
Nov

19,
19,
19,
19,
14,
14,
17,
17,
17,
17,
19,
19,

2015
2015
2015
2015
2014
2015
2017
2017
2017
2017
2015
2015

U-431
U-286
U-431
U-286
U-358
U-358

EXCLUSIVITY
EXPIRATION
DATE

Nov

01, 2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 152 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PAROXETINE HYDROCHLORIDE - PAXIL

N020031 005 5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6113944
Dec
6113944*PED
Jun
6121291
Mar
6121291
Mar
6121291*PED
Sep
6121291*PED
Sep
6133289
May
6133289*PED
Nov

19,
19,
19,
19,
14,
14,
17,
17,
17,
17,
19,
19,

2015
2015
2015
2015
2014
2015
2017
2017
2017
2017
2015
2015

U-431
U-286
U-286
U-431
U-358
U-358

PAROXETINE HYDROCHLORIDE - PAXIL

N020710 001 5811436
Sep
5811436*PED
Mar
5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6121291
Mar
6121291
Mar
6121291*PED
Sep
6121291*PED
Sep
6133289
May
6133289*PED
Nov

22,
22,
19,
19,
19,
19,
17,
17,
17,
17,
19,
19,

2015
2016
2015
2015
2015
2015
2017
2017
2017
2017
2015
2015

U-286
U-431
U-286
U-431
U-358
U-358

PAROXETINE HYDROCHLORIDE - PAXIL

N020885 001 5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6063927
Apr
6063927*PED
Oct
6080759
May
6080759*PED
Nov
6121291
Mar
6121291
Mar
6121291*PED
Sep
6121291*PED
Sep
6133289
May
6133289*PED
Nov
6172233
Jan
6172233*PED
Jul

19,
19,
19,
19,
23,
23,
19,
19,
17,
17,
17,
17,
19,
19,
15,
15,

2015
2015
2015
2015
2019
2019
2015
2015
2017
2017
2017
2017
2015
2015
2018
2018

PAROXETINE HYDROCHLORIDE - PAXIL

N020885 002 5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6063927
Apr
6063927*PED
Oct
6080759
May
6080759*PED
Nov
6121291
Mar
6121291
Mar
6121291*PED
Sep
6121291*PED
Sep
6133289
May
6133289*PED
Nov
6172233
Jan
6172233*PED
Jul

19,
19,
19,
19,
23,
23,
19,
19,
17,
17,
17,
17,
19,
19,
15,
15,

2015
2015
2015
2015
2019
2019
2015
2015
2017
2017
2017
2017
2015
2015
2018
2018

U-286
U-431
U-431
U-286
U-358
U-358

U-431
U-286
U-431
U-286
U-358
U-358

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 153 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PAROXETINE HYDROCHLORIDE - PAXIL

N020885 003 5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6063927
Apr
6063927*PED
Oct
6080759
May
6080759*PED
Nov
6121291
Mar
6121291
Mar
6121291*PED
Sep
6121291*PED
Sep
6133289
May
6133289*PED
Nov
6172233
Jan
6172233*PED
Jul

19,
19,
19,
19,
23,
23,
19,
19,
17,
17,
17,
17,
19,
19,
15,
15,

2015
2015
2015
2015
2019
2019
2015
2015
2017
2017
2017
2017
2015
2015
2018
2018

PAROXETINE HYDROCHLORIDE - PAXIL

N020885 004 5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6062927
Apr
6063927*PED
Oct
6080759
May
6080759*PED
Nov
6121291
Mar
6121291
Mar
6121291*PED
Sep
6121291*PED
Sep
6133289
May
6133289*PED
Nov
6172233
Jan
6172233*PED
Jul

19,
19,
19,
19,
23,
23,
19,
19,
17,
17,
17,
17,
19,
19,
15,
15,

2015
2015
2015
2015
2019
2019
2015
2015
2017
2017
2017
2017
2015
2015
2018
2018

PAROXETINE HYDROCHLORIDE - PAXIL CR

N020936 001 5422123
Jun
5422123*PED
Dec
5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6121291
Mar
6121291*PED
Sep
6133289
May
6133289*PED
Nov
6548084
Jul
6548084*PED
Jan
7229640
Jul

06,
06,
19,
19,
19,
19,
17,
17,
19,
19,
19,
19,
19,

2012
2012
2015
2015
2015
2015
2017
2017
2015
2015
2016
2017
2016

PAROXETINE HYDROCHLORIDE - PAXIL CR

N020936 002 5422123
Jun
5422123*PED
Dec
5872132
May
5872132*PED
Nov
5900423
May
5900423*PED
Nov
6121291
Mar
6121291*PED
Sep
6133289
May
6133289*PED
Nov
6548084
Jul
6548084*PED
Jan
7229640
Jul

06,
06,
19,
19,
19,
19,
17,
17,
19,
19,
19,
19,
19,

2012
2012
2015
2015
2015
2015
2017
2017
2015
2015
2016
2017
2016

PATENT
CODES

U-431
U-286
U-286
U-431
U-358
U-358

U-431
U-286
U-286
U-431
U-358
U-358

U-286
U-286
U-286
U-286

DP

U-816

U-286
U-286
U-286
U-286

DP

U-816

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 154 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

PAROXETINE HYDROCHLORIDE - PAXIL CR

Jun
N020936 003 5422123
Dec
5422123*PED
May
5872132
Nov
5872132*PED
May
5900423
Nov
5900423*PED
Mar
6121291
Sep
6121291*PED
May
6133289
Nov
6133289*PED
Jul
6548084
Jan
6548084*PED
Jul
7229640

06,
06,
19,
19,
19,
19,
17,
17,
19,
19,
19,
19,
19,

2012
2012
2015
2015
2015
2015
2017
2017
2015
2015
2016
2017
2016

PAROXETINE MESYLATE - PEXEVA

N021299 001 5874447
5874447
5874447
6703408
7598271

Jun
Jun
Jun
Oct
Feb

10,
10,
10,
21,
11,

2017
2017
2017
2022
2023

PAROXETINE MESYLATE - PEXEVA

N021299 002 5874447
5874447
5874447
6703408
7598271

Jun
Jun
Jun
Oct
Feb

10,
10,
10,
21,
11,

2017
2017
2017
2022
2023

PAROXETINE MESYLATE - PEXEVA

N021299 003 5874447
5874447
5874447
6703408
7598271

Jun
Jun
Jun
Oct
Feb

10,
10,
10,
21,
11,

2017
2017
2017
2022
2023

PAROXETINE MESYLATE - PEXEVA

N021299 004 5874447
5874447
5874447
6703408
7598271

Jun
Jun
Jun
Oct
Feb

10,
10,
10,
21,
11,

2017
2017
2017
2022
2023

DS

DP
DP

PAZOPANIB HYDROCHLORIDE - VOTRIENT

N022465 001 7105530
Dec
7262203
Dec

19, 2021
19, 2021

DS
DS

DP
DP

NCE

Oct

19, 2014

PAZOPANIB HYDROCHLORIDE - VOTRIENT

N022465 002 7105530
Dec
7262203
Dec

19, 2021
19, 2021

DS
DS

DP
DP

NCE

Oct

19, 2014

PEGAPTANIB SODIUM - MACUGEN

N021756 001 5919455
5932462
6011020
6051698
6113906

Oct
Aug
Jan
May
Oct

27,
03,
04,
19,
27,

2013
2016
2017
2015
2013

DS
DS
DS
DS
DS

PEGVISOMANT - SOMAVERT
N021106 001 5350836
5681809
5849535
5958879
6057292
6583115

Sep
Sep
Mar
Sep
Sep
Sep

27,
27,
25,
27,
21,
27,

2011
2011
2017
2011
2015
2011

U-286
U-286
U-286
U-286

DP

U-816

U-286
U-518
U-46
DS

DP
DP

U-518
U-46
U-286
DS

DP
DP

U-518
U-46
U-286
DS

DP
DP

U-46
U-518
U-286

U-622

U-507
U-507
DS
U-507
U-507
U-507

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 155 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PEGVISOMANT - SOMAVERT
N021106 002 5350836
5681809
5849535
5958879
6057292
6583115

Sep
Sep
Mar
Sep
Sep
Sep

27,
27,
25,
27,
21,
27,

2011
2011
2017
2011
2015
2011

PEGVISOMANT - SOMAVERT
N021106 003 5350836
5681809
5849535
5958879
6057292
6583115

Sep
Sep
Mar
Sep
Sep
Sep

27,
27,
25,
27,
21,
27,

2011
2011
2017
2011
2015
2011

PEMETREXED DISODIUM - ALIMTA

N021462 001 5217974*PED
5344932
5344932*PED
7772209
7772209*PED

Sep
Jul
Jan
Nov
May

29,
24,
24,
24,
24,

2011
2016
2017
2021
2022

PEMETREXED DISODIUM - ALIMTA

N021462 002 5217974*PED
5344932
5344932*PED
7772209
7772209*PED

Sep
Jul
Jan
Nov
May

29,
24,
24,
24,
24,

2011
2016
2017
2021
2022

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-507
U-507
DS
U-507
U-507
U-507

U-507
U-507
DS
U-507
U-507
U-507

I-601
I-571
M-61
PED
PED
PED
PED

Jul
Sep
Mar
Sep
Aug
Mar
Jan

02,
26,
17,
17,
04,
26,
02,

2012
2011
2014
2014
2011
2012
2013

I-601
I-571
M-61
PED
PED
PED
PED

Jul
Sep
Mar
Sep
Aug
Mar
Jan

02,
26,
17,
17,
04,
26,
02,

2012
2011
2014
2014
2011
2012
2013

PENTETATE CALCIUM TRISODIUM - PENTETATE CALCIUM TRISODIUM

N021749 001

ODE

Aug

11, 2011

PENTETATE ZINC TRISODIUM - PENTETATE ZINC TRISODIUM

N021751 001

ODE

Aug

11, 2011

DS

DP
U-1077

DS

DP
U-1077

PEMIROLAST POTASSIUM - ALAMAST

N021079 001 5034230*PED
Jul

02, 2011

U-184

PENCICLOVIR SODIUM - DENAVIR

N020629 001 5840763
5866581
5916893
6124304
6469015
6579981

01,
04,
01,
04,
22,
17,

U-501
U-501
U-501
U-501
U-501
U-501

Sep
Oct
Sep
Oct
Oct
Jun

2015
2014
2015
2014
2019
2020

PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE - SKIN EXPOSURE REDUCTION PASTE AGAINST

CHEMICAL WARFARE AGENTS
N021084 001 5607979
May 30, 2015
PERFLUTREN - DEFINITY
N021064 001 5527521
5585112
6033645

Feb
Dec
Jun

22, 2015
17, 2013
19, 2016

DP
DP

U-665
U-665

PHENTERMINE HYDROCHLORIDE - SUPRENZA

N202088 001 6149938
Jul 23, 2018

DP

PHENTERMINE HYDROCHLORIDE - SUPRENZA

N202088 002 6149938
Jul 23, 2018

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 156 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PHENTOLAMINE MESYLATE - ORAVERSE

N022159 001 6764678
May
6872390
May
7229630
Jun
7569230
Oct
7575757
Apr

11,
11,
20,
17,
21,

2021
2021
2023
2023
2025

PIMECROLIMUS - ELIDEL
N021302 001 5912238
5912238*PED
6352998
6352998*PED
6423722
6423722*PED

Jun
Dec
Oct
Apr
Jun
Dec

15,
15,
26,
26,
26,
26,

2016
2016
2015
2016
2018
2018

PIOGLITAZONE HYDROCHLORIDE - ACTOS

N021073 001 5965584
Jun
6150383
Jun
6150384
Jun
6166042
Jun
6166043
Jun
6172090
Jun
6211205
Jun
6271243
Jun
6303640
Aug
6329404
Jun

19,
19,
19,
19,
19,
19,
19,
19,
09,
19,

2016
2016
2016
2016
2016
2016
2016
2016
2016
2016

U-753
U-418
U-419
U-414
U-415
U-416
U-410
U-411
U-425
U-753

PIOGLITAZONE HYDROCHLORIDE - ACTOS

N021073 002 5965584
Jun
6150383
Jun
6150384
Jun
6166042
Jun
6166043
Jun
6172090
Jun
6211205
Jun
6271243
Jun
6303640
Aug
6329404
Jun

19,
19,
19,
19,
19,
19,
19,
19,
09,
19,

2016
2016
2016
2016
2016
2016
2016
2016
2016
2016

U-753
U-418
U-419
U-414
U-415
U-416
U-410
U-411
U-425
U-753

PIOGLITAZONE HYDROCHLORIDE - ACTOS

N021073 003 5965584
Jun
6150383
Jun
6150384
Jun
6166042
Jun
6166043
Jun
6172090
Jun
6211205
Jun
6271243
Jun
6303640
Aug
6329404
Jun

19,
19,
19,
19,
19,
19,
19,
19,
09,
19,

2016
2016
2016
2016
2016
2016
2016
2016
2016
2016

U-753
U-418
U-419
U-414
U-415
U-416
U-410
U-411
U-425
U-753

U-967
DP
DP
U-967
DP

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN

N050684 001 6900184
Apr 14, 2023
7915229
Apr 14, 2023

DP
DP

U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN

N050684 002 6900184
Apr 14, 2023
7915229
Apr 14, 2023

DP
DP

U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN

N050684 003 6900184
Apr 14, 2023
7915229
Apr 14, 2023

DP
DP

U-282

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN

N050684 004 6900184
Apr 14, 2023
7915229
Apr 14, 2023

DP
DP

U-282

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 157 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER

DP
N050750 001 6207661
Feb 22, 2019
DP U-282
6900184
Apr 14, 2023
DP
Apr 14, 2023
7915229
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER
N050750 002 6207661
Feb 22, 2019
DP
DP U-282
6900184
Apr 14, 2023
DP
7915229
Apr 14, 2023
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER
DP
N050750 003 6207661
Feb 22, 2019
DP U-282
6900184
Apr 14, 2023
DP
Apr 14, 2023
7915229
PITAVASTATIN CALCIUM - LIVALO
N022363 001 5753675
5854259
5856336
6465477
7022713

May
Dec
Jan
Dec
Feb

19,
29,
05,
20,
19,

2015
2015
2016
2016
2024

DS

PITAVASTATIN CALCIUM - LIVALO

N022363 002 5753675
5854259
5856336
6465477
7022713

May
Dec
Jan
Dec
Feb

19,
29,
05,
20,
19,

2015
2015
2016
2016
2024

DS

PITAVASTATIN CALCIUM - LIVALO

N022363 003 5753675
5854259
5856336
6465477
7022713

May
Dec
Jan
Dec
Feb

19,
29,
05,
20,
19,

2015
2015
2016
2016
2024

DS

PLERIXAFOR - MOZOBIL
N022311 001 6987102
7897590
RE42152

Jul
Jul
Dec

22, 2023
22, 2023
10, 2013

DP
DP

U-998

NCE

Aug

03, 2014

NCE

Aug

03, 2014

NCE

Aug

03, 2014

NCE
ODE

Dec
Dec

15, 2013
15, 2015

POLIDOCANOL - ASCLERA
N021201 001

NCE

Mar

30, 2015

POLIDOCANOL - ASCLERA
N021201 002

NCE

Mar

30, 2015

DS

U-998
DP
U-998

DP
DP

DS

U-998
U-998

DP
U-998

DP
DP

DS

U-998
U-998

DP
U-998

U-936
U-936
DP

PORFIMER SODIUM - PHOTOFRIN

N020451 001 5438071

Aug

01, 2012

POSACONAZOLE - NOXAFIL
N022003 001 5661151
5703079
6958337

Jul
Aug
Oct

19, 2019
26, 2014
05, 2018

DS
DS
DS

DP
DP
DP

U-760
U-760
U-760

NCE

Sep

15, 2011

PRALATREXATE - FOLOTYN
N022468 001 6028071
7622470

Jul
May

16, 2017
31, 2025

DS

DP

U-1004
U-1015

NCE
ODE

Sep
Sep

24, 2014
24, 2016

PRALATREXATE - FOLOTYN
N022468 002 6028071
7622470

Jul
May

16, 2017
31, 2025

DS

DP

U-1004
U-1015

NCE
ODE

Sep
Sep

24, 2014
24, 2016

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N020667 001 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784
U-784

M-104

May

13, 2014

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N020667 002 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784
U-784

M-104

May

13, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 158 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N020667 003 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784
U-784

M-104

May

13, 2014

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N020667 005 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784
U-784

M-104

May

13, 2014

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N020667 006 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784
U-784

M-104

May

13, 2014

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX

N020667 007 6001861
Jan 16, 2018
6194445
Jan 16, 2018

U-784
U-784

M-104

May

13, 2014

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

Apr 26, 2028
N022421 001 7695734

DP

I-623
NDF

Mar
Feb

19, 2013
19, 2013

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N022421 002 7695734
Apr 26, 2028

DP

I-623
NDF

Mar
Feb

19, 2013
19, 2013

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N022421 003 7695734
Apr 26, 2028

DP

I-623
NDF

Mar
Feb

19, 2013
19, 2013

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N022421 004 7695734
Apr 26, 2028

DP

I-623
NDF

Mar
Feb

19, 2013
19, 2013

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N022421 005 7695734
Apr 26, 2028

DP

I-623
NDF

Mar
Feb

19, 2013
19, 2013

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

N022421 006 7695734
Apr 26, 2028

DP

I-623
NDF

Mar
Feb

19, 2013
19, 2013

PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER

Apr 26, 2028
N022421 007 7695734

DP

I-623
NDF

Mar
Feb

19, 2013
19, 2013

PRAMLINTIDE ACETATE - SYMLIN

N021332 001 5686411
5814600
6114304
6608029

Mar
Sep
Sep
Sep

16,
29,
05,
07,

2019
2015
2017
2013

DS

DP

U-638
U-639
U-640
U-641

PRAMLINTIDE ACETATE - SYMLIN

N021332 002 5686411
5814600
5814600
5814600
6114304
6114304
6608029
6608029
6608029

Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

16,
29,
29,
29,
05,
05,
07,
07,
07,

2019
2015
2015
2015
2017
2017
2013
2013
2013

DS

DP

U-638
U-639
U-638
U-637
U-640
U-637
U-641
U-640
U-637

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 159 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PRAMLINTIDE ACETATE - SYMLIN

N021332 003 5686411
5814600
5814600
5814600
6114304
6114304
6608029
6608029
6608029

PATENT
EXPIRATION
DATE

Mar
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

2019
2015
2015
2015
2017
2017
2013
2013
2013

DS

DP

U-638
U-638
U-637
U-639
U-640
U-637
U-641
U-640
U-637

PRASUGREL HYDROCHLORIDE - EFFIENT

Apr
N022307 001 5288726
Jul
6693115

14, 2017
03, 2021

DS
DS

DP
DP

U-991
U-991

NCE

Jul

10, 2014

PRASUGREL HYDROCHLORIDE - EFFIENT

Apr
N022307 002 5288726
Jul
6693115

14, 2017
03, 2021

DS
DS

DP
DP

U-991
U-991

NCE

Jul

10, 2014

PRAVASTATIN SODIUM - PRAVACHOL

Apr
N019898 002 5622985
Oct
5622985*PED

22, 2014
22, 2014

U-335
U-335

PRAVASTATIN SODIUM - PRAVACHOL

N019898 003 5622985
Apr
5622985*PED
Oct

22, 2014
22, 2014

U-335
U-335

PRAVASTATIN SODIUM - PRAVACHOL

Apr
N019898 004 5622985
Oct
5622985*PED

22, 2014
22, 2014

U-335
U-335

PRAVASTATIN SODIUM - PRAVACHOL

N019898 008 5622985
Apr
5622985*PED
Oct

22, 2014
22, 2014

U-335
U-335

PREDNISOLONE ACETATE - FLO-PRED

N022067 001 5881926
Mar
6071523
Jun
6102254
Mar
6399079
Jun
6656482
Jun

16,
03,
11,
03,
03,

2016
2018
2013
2018
2018

DP
DP
DP
DP
DP

PREDNISOLONE ACETATE - FLO-PRED

N022067 002 5881926
Mar
6071523
Jun
6102254
Mar
6399079
Jun
6656482
Jun

16,
03,
11,
03,
03,

2016
2018
2013
2018
2018

DP
DP
DP
DP
DP

PREDNISOLONE SODIUM PHOSPHATE - ORAPRED

N021959 001 6024981
Apr 09,
6221392
Apr 09,
Nov 24,
6740341

ODT
2018
2018
2019

DP
DP
DP

Y
Y

PREDNISOLONE SODIUM PHOSPHATE - ORAPRED

Apr 09,
N021959 002 6024981
Apr 09,
6221392
Nov 24,
6740341

ODT
2018
2018
2019

DP
DP
DP

Y
Y

PREDNISOLONE SODIUM PHOSPHATE - ORAPRED

Apr 09,
N021959 003 6024981
Apr 09,
6221392
Nov 24,
6740341

ODT
2018
2018
2019

DP
DP
DP

Y
Y

PREGABALIN - LYRICA
N021446 001 5563175
6001876
6001876
6197819
RE41920

2013
2018
2018
2018
2018

Oct
Dec
Dec
Dec
Dec

16,
29,
29,
29,
05,
05,
07,
07,
07,

PATENT
CODES

08,
30,
30,
30,
30,

U-661
U-55
U-819
DS

DP
U-1099

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 160 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PREGABALIN - LYRICA
N021446 002 5563175
6001876
6001876
6197819
RE41920

Oct
Dec
Dec
Dec
Dec

08,
30,
30,
30,
30,

2013
2018
2018
2018
2018

PREGABALIN - LYRICA
N021446 003 5563175
6001876
6001876
6197819
RE41920

Oct
Dec
Dec
Dec
Dec

08,
30,
30,
30,
30,

2013
2018
2018
2018
2018

PREGABALIN - LYRICA
N021446 004 5563175
6001876
6001876
6197819
RE41920

Oct
Dec
Dec
Dec
Dec

08,
30,
30,
30,
30,

2013
2018
2018
2018
2018

PREGABALIN - LYRICA
N021446 005 5563175
6001876
6001876
6197819
RE41920

Oct
Dec
Dec
Dec
Dec

08,
30,
30,
30,
30,

2013
2018
2018
2018
2018

PREGABALIN - LYRICA
N021446 006 5563175
6001876
6001876
6197819
RE41920

Oct
Dec
Dec
Dec
Dec

08,
30,
30,
30,
30,

2013
2018
2018
2018
2018

PREGABALIN - LYRICA
N021446 007 5563175
6001876
6001876
6197819
RE41920

Oct
Dec
Dec
Dec
Dec

08,
30,
30,
30,
30,

2013
2018
2018
2018
2018

PREGABALIN - LYRICA
N021446 008 5563175
6001876
6001876
6197819
RE41920

Oct
Dec
Dec
Dec
Dec

08,
30,
30,
30,
30,

2013
2018
2018
2018
2018

PREGABALIN - LYRICA
N022488 001 5563175
6001876
6001876
6197819
RE41920

Oct
Dec
Dec
Dec
Dec

08,
30,
30,
30,
30,

2013
2018
2018
2018
2018

PATENT
CODES
U-661
U-55
U-819
DS

DP
U-1099

U-661
U-55
U-819
DS

DP
U-1099

U-661
U-55
U-819
DS

DP
U-1099

U-661
U-819
U-55
DS

DP
U-1099

U-661
U-55
U-819
DS

DP
U-1099

U-661
U-55
U-819
DS

DP
U-1099

U-661
U-55
U-819
DS

DP
U-1099

U-661
U-55
U-819
DS

DP
U-1099

PROCAINAMIDE HYDROCHLORIDE - PROCANBID

N020545 001 5656296
Aug 12, 2014
PROCAINAMIDE HYDROCHLORIDE - PROCANBID
N020545 002 5656296
Aug 12, 2014
PROGESTERONE - CRINONE
N020701 001 5543150

Sep

15, 2013

U-209

PROGESTERONE - CRINONE
N020701 002 5543150

Sep

15, 2013

U-209

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 161 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PROGESTERONE - ENDOMETRIN
N022057 001 7300664
7320800
7393543

PATENT
EXPIRATION
DATE

Nov
Nov
Nov

PATENT
CODES

17, 2019
17, 2019
17, 2019

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-856
U-856
U-880

PROPAFENONE HYDROCHLORIDE - RYTHMOL SR

N021416 001 5681588
Oct 28, 2014
PROPAFENONE HYDROCHLORIDE - RYTHMOL SR
N021416 002 5681588
Oct 28, 2014
PROPAFENONE HYDROCHLORIDE - RYTHMOL SR
N021416 003 5681588
Oct 28, 2014
PROPOFOL - DIPRIVAN
N019627 002 5714520
5714520*PED
5731355
5731355*PED
5731356
5731356*PED
5908869
5908869*PED

Mar
Sep
Mar
Sep
Mar
Sep
Mar
Sep

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

2015
2015
2015
2015
2015
2015
2015
2015

U-217
U-217
U-218
U-218
U-270
U-270

PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL

N021438 001 6500454
Dec 31, 2022
PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL
N021438 002 6500454
Dec 31, 2022
QUAZEPAM - DORAL
N018708 001 7608616

Jun

03, 2028

U-1012

QUAZEPAM - DORAL
N018708 003 7608616

Jun

03, 2028

U-1012

QUETIAPINE FUMARATE - SEROQUEL

N020639 001 4879288
Sep
4879288*PED
Mar

26, 2011
26, 2012

DS

DP

U-550

NPP
NPP
PED
PED
PED

Dec
Dec
Jun
Jun
Nov

02,
02,
02,
02,
13,

2012
2012
2013
2013
2011

QUETIAPINE FUMARATE - SEROQUEL

Sep
N020639 002 4879288
Mar
4879288*PED

26, 2011
26, 2012

DS

DP

U-550

NPP
NPP
PED
PED
PED

Dec
Dec
Jun
Jun
Nov

02,
02,
02,
02,
13,

2012
2012
2013
2013
2011

QUETIAPINE FUMARATE - SEROQUEL

N020639 003 4879288
Sep
4879288*PED
Mar

26, 2011
26, 2012

DS

DP

U-550

NPP
NPP
PED
PED
PED

Dec
Dec
Jun
Jun
Nov

02,
02,
02,
02,
13,

2012
2012
2013
2013
2011

QUETIAPINE FUMARATE - SEROQUEL

Sep
N020639 004 4879288
Mar
4879288*PED

26, 2011
26, 2012

DS

DP

U-550

NPP
NPP
PED
PED
PED

Dec
Dec
Jun
Jun
Nov

02,
02,
02,
02,
13,

2012
2012
2013
2013
2011

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 162 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

QUETIAPINE FUMARATE - SEROQUEL

Sep
N020639 005 4879288
Mar
4879288*PED

26, 2011
26, 2012

DS

DP

U-550

NPP
NPP
PED
PED
PED

Dec
Dec
Jun
Jun
Nov

02,
02,
02,
02,
13,

2012
2012
2013
2013
2011

QUETIAPINE FUMARATE - SEROQUEL

N020639 006 4879288
Sep
4879288*PED
Mar

26, 2011
26, 2012

DS

DP

U-550

NPP
NPP
PED
PED
PED

Dec
Dec
Jun
Jun
Nov

02,
02,
02,
02,
13,

2012
2012
2013
2013
2011

QUETIAPINE FUMARATE - SEROQUEL

N020639 007 4879288
Sep
4879288*PED
Mar

26, 2011
26, 2012

DS

DP

U-550

NPP
NPP
PED
PED
PED

Dec
Dec
Jun
Jun
Nov

02,
02,
02,
02,
13,

2012
2012
2013
2013
2011

QUETIAPINE FUMARATE - SEROQUEL

N022047 001 4879288
4879288
4879288
4879288*PED
5948437
5948437
5948437
5948437*PED

XR
Sep
Sep
Sep
Mar
May
May
May
Nov

26,
26,
26,
26,
28,
28,
28,
28,

2011
2011
2011
2012
2017
2017
2017
2017

DS
DS
DS

DP
DP
DP

U-601
U-814
U-839

DP
DP
DP

U-839
U-814
U-601

D-117
I-618
I-576
I-575
I-574
PED
PED
PED
PED

Oct
Dec
Oct
Oct
Oct
Apr
Apr
Apr
Apr

08,
02,
08,
08,
08,
08,
08,
08,
08,

2011
2012
2011
2011
2011
2012
2012
2012
2012

QUETIAPINE FUMARATE - SEROQUEL

N022047 002 4879288
4879288
4879288
4879288*PED
5948437
5948437
5948437
5948437*PED

XR
Sep
Sep
Sep
Mar
May
May
May
Nov

26,
26,
26,
26,
28,
28,
28,
28,

2011
2011
2011
2012
2017
2017
2017
2017

DS
DS
DS

DP
DP
DP

U-601
U-814
U-839

DP
DP
DP

U-814
U-601
U-839

D-117
I-618
I-576
I-575
I-574
PED
PED
PED
PED

Oct
Dec
Oct
Oct
Oct
Apr
Apr
Apr
Apr

08,
02,
08,
08,
08,
08,
08,
08,
08,

2011
2012
2011
2011
2011
2012
2012
2012
2012

QUETIAPINE FUMARATE - SEROQUEL

N022047 003 4879288
4879288
4879288
4879288*PED
5948437
5948437
5948437
5948437*PED

XR
Sep
Sep
Sep
Mar
May
May
May
Nov

26,
26,
26,
26,
28,
28,
28,
28,

2011
2011
2011
2012
2017
2017
2017
2017

DS
DS
DS

DP
DP
DP

U-839
U-601
U-814

DP
DP
DP

U-601
U-814
U-839

D-117
I-618
I-576
I-575
I-574
PED
PED
PED
PED

Oct
Dec
Oct
Oct
Oct
Apr
Apr
Apr
Apr

08,
02,
08,
08,
08,
08,
08,
08,
08,

2011
2012
2011
2011
2011
2012
2012
2012
2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 163 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

QUETIAPINE FUMARATE - SEROQUEL

N022047 004 4879288
4879288
4879288
4879288*PED
5948437
5948437
5948437
5948437*PED

XR
Sep
Sep
Sep
Mar
May
May
May
Nov

26,
26,
26,
26,
28,
28,
28,
28,

2011
2011
2011
2012
2017
2017
2017
2017

DS
DS
DS

QUETIAPINE FUMARATE - SEROQUEL

N022047 005 4879288
4879288
4879288
4879288*PED
5948437
5948437
5948437
5948437*PED

XR
Sep
Sep
Sep
Mar
May
May
May
Nov

26,
26,
26,
26,
28,
28,
28,
28,

2011
2011
2011
2012
2017
2017
2017
2017

DS
DS
DS

DP
DP
DP

U-814
U-601
U-839

DP
DP
DP

U-814
U-601
U-839

DP
DP
DP

U-814
U-601
U-839

DP
DP
DP

U-839
U-814
U-601

QUINAPRIL HYDROCHLORIDE - ACCUPRIL

N019885 001 5684016
Nov
5684016*PED
May

04, 2014
04, 2015

U-210
U-210

QUINAPRIL HYDROCHLORIDE - ACCUPRIL

N019885 002 5684016
Nov
5684016*PED
May

04, 2014
04, 2015

U-210
U-210

QUINAPRIL HYDROCHLORIDE - ACCUPRIL

N019885 003 5684016
Nov
5684016*PED
May

04, 2014
04, 2015

U-210
U-210

QUINAPRIL HYDROCHLORIDE - ACCUPRIL

N019885 004 5684016
Nov
5684016*PED
May

04, 2014
04, 2015

U-210
U-210

PATENT
DELIST
REQUESTED

QUININE SULFATE - QUALAQUIN

N021799 001
RABEPRAZOLE SODIUM - ACIPHEX
N020973 001 5045552

May

08, 2013

U-385

RABEPRAZOLE SODIUM - ACIPHEX

N020973 002 5045552

May

08, 2013

U-385

28,
28,
02,
02,
02,
10,
10,
10,
28,
28,
10,
28,
28,
28,
28,
02,
02,

U-114
U-114
U-114

RALOXIFENE HYDROCHLORIDE - EVISTA

N020815 001 5393763
Jul
5457117
Jul
5478847
Mar
5811120
Mar
5972383
Mar
6458811
Mar
6797719
Mar
6894064
Mar
6906086
Jul
6906086
Jul
8030330
Mar
RE38968
Jul
RE38968
Jul
RE39049
Jul
RE39049
Jul
RE39050
Mar
RE39050
Mar

2012
2012
2014
2014
2014
2017
2017
2017
2012
2012
2017
2012
2012
2012
2012
2014
2014

DS

DP
DP
DP

U-287
U-825
U-657
U-662
U-657

DP
U-662
U-657
U-662
U-657
U-657
U-662

Y
Y
Y

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

D-117
I-618
I-576
I-575
I-574
PED
PED
PED
PED

Oct
Dec
Oct
Oct
Oct
Apr
Apr
Apr
Apr

08,
02,
08,
08,
08,
08,
08,
08,
08,

2011
2012
2011
2011
2011
2012
2012
2012
2012

D-117
I-618
I-576
I-575
I-574
PED
PED
PED
PED

Oct
Dec
Oct
Oct
Oct
Apr
Apr
Apr
Apr

08,
02,
08,
08,
08,
08,
08,
08,
08,

2011
2012
2011
2011
2011
2012
2012
2012
2012

ODE

Aug

12, 2012

ODE

Sep

13, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 164 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

RALTEGRAVIR POTASSIUM - ISENTRESS

N022145 001 7169780
Oct
7217713
Oct
7435734
Oct
7435734
Oct
7754731
Mar

03,
21,
21,
21,
11,

2023
2022
2022
2022
2029

PATENT
CODES
DS

PATENT
DELIST
REQUESTED

DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NPP
NCE

Dec
Oct

21, 2014
12, 2012

RALTEGRAVIR POTASSIUM - ISENTRESS

N203045 001

NDF

Dec

21, 2014

RALTEGRAVIR POTASSIUM - ISENTRESS

N203045 002

NDF

Dec

21, 2014

M-82

Oct

20, 2011

DS

DP

U-257
U-900
U-257
U-257

RAMELTEON - ROZEREM
N021782 001 6034239

Jul

22, 2019

RAMIPRIL - ALTACE
N019901 001 5403856
7368469

Apr
Aug

04, 2012
30, 2020

U-71
U-871

RAMIPRIL - ALTACE
N019901 002 5403856
7368469

Apr
Aug

04, 2012
30, 2020

U-71
U-871

RAMIPRIL - ALTACE
N019901 003 5403856
7368469

Apr
Aug

04, 2012
30, 2020

U-71
U-871

RAMIPRIL - ALTACE
N019901 004 5403856
7368469

Apr
Aug

04, 2012
30, 2020

U-71
U-871

RAMIPRIL - ALTACE
N022021 001 5403856
7368469

Apr
Aug

04, 2012
30, 2020

U-71
U-871

RAMIPRIL - ALTACE
N022021 002 5403856
7368469

Apr
Aug

04, 2012
30, 2020

U-71
U-871

RAMIPRIL - ALTACE
N022021 003 5403856
7368469

Apr
Aug

04, 2012
30, 2020

U-71
U-871

RAMIPRIL - ALTACE
N022021 004 5403856
7368469

Apr
Aug

04, 2012
30, 2020

U-71
U-871

DS

DP

RANITIDINE BISMUTH CITRATE - TRITEC

N020559 001 5403830
Apr 04, 2012
5407688
Apr 04, 2012
Oct 10, 2012
5456925
Feb 11, 2014
5601848
May 13, 2014
5629297
RANOLAZINE - RANEXA
N021526 001 6303607
6369062
6479496
6503911
6525057
6562826
6617328
6620814
6852724
6864258

May
May
May
May
May
May
May
May
May
May

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,

2019
2019
2019
2019
2019
2019
2019
2019
2019
2019

U-674

U-200
U-201
U-202
U-186

U-705
DP

Y
U-705

DP
U-705
U-705
DP
U-705
U-705
U-705

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 165 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

RANOLAZINE - RANEXA
N021526 002 6303607
6369062
6479496
6503911
6525057
6562826
6617328
6620814
6852724
6864258

May
May
May
May
May
May
May
May
May
May

27,
27,
27,
27,
27,
27,
27,
27,
27,
27,

RAPACURONIUM BROMIDE - RAPLON

N020984 001 5418226

Apr

14, 2013

RAPACURONIUM BROMIDE - RAPLON

N020984 002 5418226

Apr

14, 2013

RASAGILINE MESYLATE - AZILECT

N021641 001 5387612
5453446
5457133
5532415
5786390
6126968
7572834
7815942

Feb
Feb
Feb
Jul
Feb
Sep
Dec
Aug

07,
07,
07,
02,
07,
18,
05,
27,

2012
2017
2012
2013
2012
2016
2026
2027

RASAGILINE MESYLATE - AZILECT

N021641 002 5387612
5453446
5457133
5532415
5786390
6126968
7572834
7815942

Feb
Feb
Feb
Jul
Feb
Sep
Dec
Aug

07,
07,
07,
02,
07,
18,
05,
27,

2012
2017
2012
2013
2012
2016
2026
2027

REGADENOSON - LEXISCAN
N022161 001 6403567
6642210
7144872
7144872
7144872
7183264
7183264
7183264
7582617
7655636
7655637
7683037

Apr
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

10,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,
22,

2022
2019
2019
2019
2019
2019
2019
2019
2019
2019
2019
2019

PATENT
CODES

2019
2019
2019
2019
2019
2019
2019
2019
2019
2019

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-705
DP
U-705
DP
U-705
U-705
DP
U-705
U-705
U-705

U-219
U-219
DS
DS

DS

DP
DP
DP
DP
DP

U-219

U-219
U-219
DS
DS

DS

DP
DP
DP
DP
DP

DS
DS
DS
DS
DS

DP
DP
DP
DP
DP
DP
DP
DP

DS

DP

REMIFENTANIL HYDROCHLORIDE - ULTIVA

N020630 001 5866591
Sep 10, 2017
Mar 10, 2018
5866591*PED

DP

REMIFENTANIL HYDROCHLORIDE - ULTIVA

N020630 002 5866591
Sep 10, 2017
Mar 10, 2018
5866591*PED

DP

REMIFENTANIL HYDROCHLORIDE - ULTIVA

N020630 003 5866591
Sep 10, 2017
Mar 10, 2018
5866591*PED

DP

U-219

U-869
U-869
U-870
U-869
U-116
U-870
U-869
U-116
U-1003
U-869
U-869
U-1042

REPAGLINIDE - PRANDIN
N020741 001 6677358

Jun

12, 2018

DS

DP

U-968

REPAGLINIDE - PRANDIN
N020741 002 6677358

Jun

12, 2018

DS

DP

U-968

NCE

Apr

10, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 166 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

REPAGLINIDE - PRANDIN
N020741 003 6677358

Jun

12, 2018

DS

DP

U-968

RETAPAMULIN - ALTABAX
N022055 001 7875630
RE39128

Feb
Apr

14, 2027
12, 2021

DS
DS

DP

U-805

RIBAVIRIN - COPEGUS
N021511 001
RIBAVIRIN - REBETOL
N020903 001 6172046
6172046
6172046*PED
6177074
6177074
6177074*PED
6461605
6461605
6461605*PED
6472373
6472373
6472373*PED
6524570
6524570
6524570*PED

Sep
Sep
Mar
Nov
Nov
May
Nov
Nov
May
Sep
Sep
Mar
Nov
Nov
May

21,
21,
21,
01,
01,
01,
01,
01,
01,
21,
21,
21,
01,
01,
01,

2017
2017
2018
2016
2016
2017
2016
2016
2017
2017
2017
2018
2016
2016
2017

U-1014
U-377
U-377
U-1013
U-454
U-454
U-478
U-1013
U-478
U-479
U-1014
U-479
U-499
U-1013
U-499

RIBAVIRIN - REBETOL
N020903 002 6172046
6172046
6172046*PED
6177074
6177074
6177074*PED
6461605
6461605
6461605*PED
6472373
6472373
6472373*PED
6524570
6524570
6524570*PED

Sep
Sep
Mar
Nov
Nov
May
Nov
Nov
May
Sep
Sep
Mar
Nov
Nov
May

21,
21,
21,
01,
01,
01,
01,
01,
01,
21,
21,
21,
01,
01,
01,

2017
2017
2018
2016
2016
2017
2016
2016
2017
2017
2017
2018
2016
2016
2017

U-377
U-1014
U-377
U-1013
U-454
U-454
U-1013
U-478
U-478
U-1014
U-479
U-479
U-499
U-1013
U-499

RIBAVIRIN - REBETOL
N021546 001 6172046
6172046
6172046*PED
6177074
6177074*PED
6461605
6461605
6461605*PED
6472373
6472373*PED
6524570
6524570*PED
6790837
6790837*PED

Sep
Sep
Mar
Nov
May
Nov
Nov
May
Sep
Mar
Nov
May
Apr
Oct

21,
21,
21,
01,
01,
01,
01,
01,
21,
21,
01,
01,
05,
05,

2017
2017
2018
2016
2017
2016
2016
2017
2017
2018
2016
2017
2023
2023

U-521
U-1014
U-521
U-1013

RIBAVIRIN - VIRAZOLE
N018859 001 6150337

Nov

21, 2017

RIFAXIMIN - XIFAXAN
N021361 001 7045620
7612199
7902206
7906542
7928115

Jun
Jun
Jun
Jun
Jul

19,
19,
19,
01,
24,

2024
2024
2024
2025
2029

U-521
U-1013
U-521
U-521
U-521
U-1013
DP
U-1014

U-400

DS
DS
DS
DS

DP
DP
DP
DP
U-1121

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Apr

12, 2012

NPP

Aug

09, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 167 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

RIFAXIMIN - XIFAXAN
N022554 001 7045620
7612199
7902206
7906542

PATENT
EXPIRATION
DATE

PATENT
CODES

2024
2024
2024
2025

DS
DS
DS
DS

RILPIVIRINE HYDROCHLORIDE - EDURANT

Feb 26, 2021
N202022 001 6838464
Dec 20, 2019
7067522
Apr 14, 2023
7125879
Apr 14, 2023
7638522

DS
DS
DS

Jun
Jun
Jun
Jun

19,
19,
19,
01,

DP
DP
DP

DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NP
ODE

Mar
Mar

24, 2013
24, 2017

NCE

May

20, 2016

U-1153

RILUZOLE - RILUTEK
N020599 001 5527814

Jun

18, 2013

RISEDRONATE SODIUM - ACTONEL

N020835 001 5583122
5583122*PED
6096342
6096342*PED
6165513
6165513*PED

Dec
Jun
Nov
May
Jun
Dec

10,
10,
22,
22,
10,
10,

2013
2014
2011
2012
2018
2018

U-222

M-61
PED

Jul
Jan

23, 2012
23, 2013

RISEDRONATE SODIUM - ACTONEL

N020835 002 5583122
5583122*PED
6096342
6096342*PED
6165513
6165513*PED

Dec
Jun
Nov
May
Jun
Dec

10,
10,
22,
22,
10,
10,

2013
2014
2011
2012
2018
2018

U-222

M-61
PED

Jul
Jan

23, 2012
23, 2013

RISEDRONATE SODIUM - ACTONEL

N020835 003 5583122
5583122
5583122*PED
5994329
5994329*PED
6015801
6015801*PED
6096342
6096342*PED
6165513
6165513*PED
6432932
6432932*PED
6465443
6465443*PED

Dec
Dec
Jun
Jul
Jan
Jul
Jan
Nov
May
Jun
Dec
Jul
Jan
Aug
Feb

10,
10,
10,
17,
17,
17,
17,
22,
22,
10,
10,
17,
17,
14,
14,

2013
2013
2014
2018
2019
2018
2019
2011
2012
2018
2018
2018
2019
2018
2019

DS
DS

U-756
U-222

M-61
PED

Jul
Jan

23, 2012
23, 2013

RISEDRONATE SODIUM - ACTONEL

N020835 004 5583122
5583122*PED
6096342
6096342*PED
6165513
6165513*PED

Dec
Jun
Nov
May
Jun
Dec

10,
10,
22,
22,
10,
10,

2013
2014
2011
2012
2018
2018

DS

M-61
PED

Jul
Jan

23, 2012
23, 2013

RISEDRONATE SODIUM - ACTONEL

N020835 005 5583122
5583122*PED
6165513
6165513*PED
7192938
7192938*PED
7718634
7718634*PED

Dec
Jun
Jun
Dec
May
Nov
May
Nov

10,
10,
10,
10,
06,
06,
06,
06,

2013
2014
2018
2018
2023
2023
2023
2023

DS

M-61
PED
PED

Jul
Jan
Oct

23, 2012
23, 2013
22, 2011

DP
DP

U-353
U-353
DP
DP
U-595
DP

DP

U-353

DP

U-353

DP

DP

U-353

DP
U-353
U-662

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 168 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

RISEDRONATE SODIUM - ATELVIA

N022560 001 5583122
5583122*PED
5622721
7645459
7645460

Dec
Jun
Apr
Jan
Jan

10,
10,
21,
09,
09,

2013
2014
2014
2028
2028

RISPERIDONE - RISPERDAL
N020588 001 5453425
5453425*PED
5616587
5616587*PED
RE39181
RE39181*PED

Jul
Jan
Jul
Jan
Jul
Jan

11,
11,
11,
11,
11,
11,

2014
2015
2014
2015
2014
2015

DP

RISPERIDONE - RISPERDAL
N021444 001 5648093
5648093*PED
6224905
6224905*PED

Jul
Jan
Jun
Dec

15,
15,
10,
10,

2014
2015
2017
2017

DP

RISPERIDONE - RISPERDAL
N021444 002 5648093
5648093*PED
6224905
6224905*PED

Jul
Jan
Jun
Dec

15,
15,
10,
10,

2014
2015
2017
2017

DP

RISPERIDONE - RISPERDAL
N021444 003 5648093
5648093*PED
6224905
6224905*PED

Jul
Jan
Jun
Dec

15,
15,
10,
10,

2014
2015
2017
2017

DP

RISPERIDONE - RISPERDAL
N021444 004 5648093
5648093*PED
6224905
6224905*PED

Jul
Jan
Jun
Dec

15,
15,
10,
10,

2014
2015
2017
2017

DP

RISPERIDONE - RISPERDAL
N021444 005 5648093
5648093*PED
6224905
6224905*PED

Jul
Jan
Jun
Dec

15,
15,
10,
10,

2014
2015
2017
2017

DP

DS

DP

U-662

DP
DP
DP

U-662
U-662
U-662

PATENT
DELIST
REQUESTED

NDF

Y
DP

DP

DP

DP

DP

DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

Oct

08, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 169 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

RISPERIDONE - RISPERDAL CONSTA

N021346 001 5688801
5688801
5688801*PED
5792477
5792477*PED
5916598
5916598*PED
5965168
5965168*PED
6110921
6110921*PED
6194006
6194006*PED
6368632
6368632*PED
6379703
6379703*PED
6403114
6403114*PED
6596316
6596316*PED
6667061
6667061*PED
7547452
7547452*PED

Nov
Nov
May
May
Nov
May
Nov
Nov
May
Nov
May
Dec
Jun
Nov
May
Dec
Jun
May
Nov
Dec
Jun
May
Nov
Nov
May

18,
18,
18,
02,
02,
02,
02,
19,
19,
19,
19,
30,
30,
19,
19,
30,
30,
02,
02,
30,
30,
25,
25,
19,
19,

2014
2014
2015
2017
2017
2017
2017
2013
2014
2013
2014
2018
2019
2013
2014
2018
2019
2017
2017
2018
2019
2020
2020
2013
2014

RISPERIDONE - RISPERDAL CONSTA

N021346 002 5688801
5688801
5688801*PED
5792477
5792477*PED
5916598
5916598*PED
5965168
5965168*PED
6110921
6110921*PED
6194006
6194006*PED
6368632
6368632*PED
6379703
6379703*PED
6403114
6403114*PED
6596316
6596316*PED
6667061
6667061*PED
7547452
7547452*PED

Nov
Nov
May
May
Nov
May
Nov
Nov
May
Nov
May
Dec
Jun
Nov
May
Dec
Jun
May
Nov
Dec
Jun
May
Nov
Nov
May

18,
18,
18,
02,
02,
02,
02,
19,
19,
19,
19,
30,
30,
19,
19,
30,
30,
02,
02,
30,
30,
25,
25,
19,
19,

2014
2014
2015
2017
2017
2017
2017
2013
2014
2013
2014
2018
2019
2013
2014
2018
2019
2017
2017
2018
2019
2020
2020
2013
2014

PATENT
CODES
U-543
U-972

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-597
I-596

May
May

15, 2012
15, 2012

I-597
I-596

May
May

15, 2012
15, 2012

DP
DP
DP
U-543
DP
U-543
DP
DP
DP
DP
DP

U-543
U-972
DP
DP
DP
U-543
DP
U-543
DP
DP
DP
DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 170 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

RISPERIDONE - RISPERDAL CONSTA

N021346 003 5688801
5688801
5688801*PED
5792477
5792477*PED
5916598
5916598*PED
5965168
5965168*PED
6110921
6110921*PED
6194006
6194006*PED
6368632
6368632*PED
6379703
6379703*PED
6403114
6403114*PED
6596316
6596316*PED
6667061
6667061*PED
7547452
7547452*PED

Nov
Nov
May
May
Nov
May
Nov
Nov
May
Nov
May
Dec
Jun
Nov
May
Dec
Jun
May
Nov
Dec
Jun
May
Nov
Nov
May

18,
18,
18,
02,
02,
02,
02,
19,
19,
19,
19,
30,
30,
19,
19,
30,
30,
02,
02,
30,
30,
25,
25,
19,
19,

2014
2014
2015
2017
2017
2017
2017
2013
2014
2013
2014
2018
2019
2013
2014
2018
2019
2017
2017
2018
2019
2020
2020
2013
2014

RISPERIDONE - RISPERDAL CONSTA

N021346 004 5688801
5688801
5688801*PED
5792477
5792477*PED
5916598
5916598*PED
5965168
5965168*PED
6110503
6110503*PED
6110921
6110921*PED
6194006
6194006*PED
6368632
6368632*PED
6379703
6379703*PED
6403114
6403114*PED
6596316
6596316*PED
6667061
6667061*PED
7547452
7547452*PED

Nov
Nov
May
May
Nov
May
Nov
Nov
May
May
Nov
Nov
May
Dec
Jun
Nov
May
Dec
Jun
May
Nov
Dec
Jun
May
Nov
Nov
May

18,
18,
18,
02,
02,
02,
02,
19,
19,
02,
02,
19,
19,
30,
30,
19,
19,
30,
30,
02,
02,
30,
30,
25,
25,
19,
19,

2014
2014
2015
2017
2017
2017
2017
2013
2014
2017
2017
2013
2014
2018
2019
2013
2014
2018
2019
2017
2017
2018
2019
2020
2020
2013
2014

PATENT
CODES
U-543
U-972

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-597
I-596

May
May

15, 2012
15, 2012

I-597
I-596

May
May

15, 2012
15, 2012

DP
DP
DP
U-543
DP
U-543
DP
DP
DP
DP
DP

U-972
U-543
DP
DP
DP
DP
U-543
DP
U-543
DP
DP
DP
DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 171 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

RITONAVIR - NORVIR
N020659 001 5484801
5484801*PED
5541206
5541206*PED
5635523
5635523*PED
5648497
5648497*PED
5674882
5674882*PED
5948436
5948436*PED
6037157
6037157*PED
6703403
6703403*PED

Jan
Jul
Jul
Jan
Jul
Jan
Jul
Jan
Jul
Jan
Sep
Mar
Jun
Dec
Jun
Dec

28,
28,
30,
30,
30,
30,
15,
15,
30,
30,
13,
13,
26,
26,
26,
26,

2014
2014
2013
2014
2013
2014
2014
2015
2013
2014
2013
2014
2016
2016
2016
2016

RITONAVIR - NORVIR
N020680 001 5541206
5541206*PED
5635523
5635523*PED
5648497
5648497*PED
5948436
5948436*PED

Jul
Jan
Jun
Dec
Jul
Jan
Sep
Mar

30,
30,
03,
03,
15,
15,
13,
13,

2013
2014
2014
2014
2014
2015
2013
2014

U-140

RITONAVIR - NORVIR
N020945 001 5541206
5541206*PED
5635523
5635523*PED
5648497
5648497*PED
5674882
5674882*PED
5948436
5948436*PED
6037157
6037157*PED
6232333
6232333*PED
6703403
6703403*PED
7141593
7141593*PED
7432294
7432294*PED

Jul
Jan
Jul
Jan
Jul
Jan
Jul
Jan
Sep
Mar
Jun
Dec
Nov
May
Jun
Dec
May
Nov
May
Nov

30,
30,
30,
30,
15,
15,
30,
30,
13,
13,
26,
26,
07,
07,
26,
26,
22,
22,
22,
22,

2013
2014
2013
2014
2014
2015
2013
2014
2013
2014
2016
2016
2017
2018
2016
2016
2020
2020
2020
2020

U-348

RITONAVIR - NORVIR
N022417 001 5541206
5541206*PED
5635523
5635523*PED
5648497
5648497*PED
5674882
5674882*PED
6037157
6037157*PED
6703403
6703403*PED
7148359
7148359*PED
7364752
7364752*PED

Jul
Jan
Jul
Jan
Jul
Jan
Jul
Jan
Jun
Dec
Jun
Dec
Jul
Jan
Nov
May

30,
30,
30,
30,
15,
15,
30,
30,
26,
26,
26,
26,
19,
19,
10,
10,

2013
2014
2013
2014
2014
2015
2013
2014
2016
2016
2016
2016
2019
2020
2020
2021

U-140
U-190

U-688
DP

U-564

U-190

U-347

U-895
DP
U-895

U-564
DP
DP

DS

DP

U-688
U-688

DS
U-688
U-688
U-688
DP
DP

U-688

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 172 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

RIVAROXABAN - XARELTO
N022406 001 7157456
7585860
7592339

Feb
Dec
Dec

08, 2021
11, 2020
11, 2020

DS
DS

RIVAROXABAN - XARELTO
N202439 001 7157456
7585860
7592339
7592339

Feb
Dec
Dec
Dec

08,
11,
11,
11,

2021
2020
2020
2020

DS
DS

RIVAROXABAN - XARELTO
N202439 002 7157456
7585860
7592339
7592339

Feb
Dec
Dec
Dec

08,
11,
11,
11,

2021
2020
2020
2020

DS
DS

RIVASTIGMINE - EXELON
N022083 001 4948807
5602176
6316023
6335031

Aug
Feb
Jan
Jan

14,
11,
08,
08,

2012
2014
2019
2019

DS
DS

RIVASTIGMINE - EXELON
N022083 002 4948807
5602176
6316023
6335031

Aug
Feb
Jan
Jan

14,
11,
08,
08,

2012
2014
2019
2019

DS
DS

RIVASTIGMINE TARTRATE - EXELON

N020823 003 4948807
Aug
5602176
Feb

14, 2012
11, 2014

DS

U-322
U-322

RIVASTIGMINE TARTRATE - EXELON

N020823 004 4948807
Aug
5602176
Feb

14, 2012
11, 2014

DS

U-322
U-322

RIVASTIGMINE TARTRATE - EXELON

N020823 005 4948807
Aug
5602176
Feb

14, 2012
11, 2014

DS

U-322
U-322

RIVASTIGMINE TARTRATE - EXELON

N020823 006 4948807
Aug
5602176
Feb

14, 2012
11, 2014

DS

U-322
U-322

RIVASTIGMINE TARTRATE - EXELON

Aug
N021025 001 4948807
Feb
5602176

14, 2012
11, 2014

DS

U-322
U-322

RIZATRIPTAN BENZOATE - MAXALT

N020864 001 5298520
5298520*PED
5602162
5602162*PED

Jun
Dec
Feb
Aug

29,
29,
11,
11,

2012
2012
2014
2014

DS

RIZATRIPTAN BENZOATE - MAXALT

N020864 002 5298520
5298520*PED
5602162
5602162*PED

Jun
Dec
Feb
Aug

29,
29,
11,
11,

2012
2012
2014
2014

DS

RIZATRIPTAN BENZOATE - MAXALT-MLT

N020865 001 5298520
Jun
5298520*PED
Dec
5457895
Oct
5457895*PED
Apr
Feb
5602162
Aug
5602162*PED

29,
29,
01,
01,
11,
11,

2012
2012
2013
2014
2014
2014

DS

PATENT
DELIST
REQUESTED

DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Jul

01, 2016

I-643
NCE

Nov
Jul

04, 2014
01, 2016

I-643
NCE

Nov
Jul

04, 2014
01, 2016

NPP
PED

Dec
Jun

15, 2014
15, 2015

NPP
PED

Dec
Jun

15, 2014
15, 2015

NPP
PED

Dec
Jun

15, 2014
15, 2015

U-1167

DP
U-1167
U-1200

DP
U-1167
U-1200

DP
DP
DP

DP
DP
DP

DP

U-322
U-322

U-322
U-322

U-240
Y

DP

U-240
Y

DP

U-240

DP
U-240

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 173 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

RIZATRIPTAN BENZOATE - MAXALT-MLT

Jun
N020865 002 5298520
Dec
5298520*PED
Oct
5457895
Apr
5457895*PED
Feb
5602162
Aug
5602162*PED

29,
29,
01,
01,
11,
11,

2012
2012
2013
2014
2014
2014

PATENT
CODES
DS

DP

PATENT
DELIST
REQUESTED

U-240

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NPP
PED

Dec
Jun

15, 2014
15, 2015

NPP
PED

Aug
Feb

28, 2011
28, 2012

NPP
PED

Aug
Feb

28, 2011
28, 2012

NPP
PED

Aug
Feb

28, 2011
28, 2012

DP
U-240

ROCURONIUM BROMIDE - ZEMURON

N020214 001
ROCURONIUM BROMIDE - ZEMURON
N020214 002
ROCURONIUM BROMIDE - ZEMURON
N020214 003
ROFECOXIB - VIOXX
N021042 001 5474995
5474995*PED
5691374
5691374*PED
6063811
6063811*PED
6239173
6239173*PED

Jun
Dec
May
Nov
May
Nov
Jun
Dec

24,
24,
18,
18,
06,
06,
24,
24,

2013
2013
2015
2015
2017
2017
2013
2013

DS

DS

DP

U-602

ROFECOXIB - VIOXX
N021042 002 5474995
5474995*PED
5691374
5691374*PED
6063811
6063811*PED
6239173
6239173*PED

Jun
Dec
May
Nov
May
Nov
Jun
Dec

24,
24,
18,
18,
06,
06,
24,
24,

2013
2013
2015
2015
2017
2017
2013
2013

DS

DP

U-602

DS

DP

U-602

ROFECOXIB - VIOXX
N021042 003 5474995
5474995*PED
5691374
5691374*PED
6063811
6063811*PED
6239173
6239173*PED

Jun
Dec
May
Nov
May
Nov
Jun
Dec

24,
24,
18,
18,
06,
06,
24,
24,

2013
2013
2015
2015
2017
2017
2013
2013

DS

DP

U-602

ROFECOXIB - VIOXX
N021052 001 5474995
5474995*PED
5691374
5691374*PED
6063811
6063811*PED
6239173
6239173*PED

Jun
Dec
May
Nov
May
Nov
Jun
Dec

24,
24,
18,
18,
06,
06,
24,
24,

2013
2013
2015
2015
2017
2017
2013
2013

U-266

ROFECOXIB - VIOXX
N021052 002 5474995
5474995*PED
5691374
5691374*PED
6063811
6063811*PED
6239173
6239173*PED

Jun
Dec
May
Nov
May
Nov
Jun
Dec

24,
24,
18,
18,
06,
06,
24,
24,

2013
2013
2015
2015
2017
2017
2013
2013

U-266

DP

U-602

U-602

U-602

U-602
DS

DP

U-602

U-266

U-266

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 174 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ROFLUMILAST - DALIRESP
N022522 001 5712298

Jan

27, 2015

DS

DP

ROMIDEPSIN - ISTODAX
N022393 001 4977138
7608280
7611724

Jul
Aug
Aug

06, 2012
22, 2021
22, 2021

DS
DS
DS

DP

PATENT
DELIST
REQUESTED

U-1115

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 001 5422123
Jun 06, 2012
7927624
Dec 02, 2021

DP

DP U-20

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 002 5422123
Jun 06, 2012
7927624
Dec 02, 2021

DP

DP U-20

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 003 5422123
Jun 06, 2012
7927624
Dec 02, 2021

DP
DP

U-20

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 004 5422123
Jun 06, 2012
7927624
Dec 02, 2021

DP
DP

U-20

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 005 5422123
Jun 06, 2012
7927624
Dec 02, 2021

DP
DP

U-20

ROPINIROLE HYDROCHLORIDE - REQUIP XL

N022008 006 5422123
Jun 06, 2012
7927624
Dec 02, 2021

DP
DP

U-20

ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN

N020533 001 5670524
May 26, 2014
DS
DS
5834489
May 26, 2014

DP
DP

U-833
U-838

ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN

DS
N020533 003 5670524
May 26, 2014
5834489
May 26, 2014
DS

DP
DP

U-833

U-838

ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN

N020533 004 5670524
May 26, 2014
DS
5834489
May 26, 2014
DS

DP
DP

U-833
U-838

ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - NAROPIN

DS
N020533 005 5670524
May 26, 2014
May 26, 2014
DS
5834489

DP
DP

U-833
U-838

DS
DS
DS

DP
DP
DP

U-840
U-329
U-628

DS
DS

DP
DP

U-628
U-329

Y
Y

U-420

ROSIGLITAZONE MALEATE - AVANDIA

N021071 002 5002953
Sep
Sep
5002953
Sep
5002953
Mar
5002953*PED
Apr
5741803
Apr
5741803
Oct
5741803*PED
Feb
6288095
Aug
6288095*PED
Apr
7358366
Oct
7358366*PED

17,
17,
17,
17,
21,
21,
21,
11,
11,
19,
19,

2011
2011
2011
2012
2015
2015
2015
2017
2017
2020
2020

DS

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Feb

28, 2016

NCE
ODE
ODE

Nov
Jun
Nov

05, 2014
16, 2018
05, 2016

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 175 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

ROSIGLITAZONE MALEATE - AVANDIA

Sep
N021071 003 5002953
Sep
5002953
Sep
5002953
Mar
5002953*PED
Apr
5741803
Apr
5741803
Oct
5741803*PED
Feb
6288095
Aug
6288095*PED
Apr
7358366
Oct
7358366*PED

17,
17,
17,
17,
21,
21,
21,
11,
11,
19,
19,

2011
2011
2011
2012
2015
2015
2015
2017
2017
2020
2020

DS
DS
DS

DP
DP
DP

U-840
U-329
U-628

DS
DS

DP
DP

U-628
U-329

Y
Y

U-420

ROSIGLITAZONE MALEATE - AVANDIA

Sep
N021071 004 5002953
Sep
5002953
Sep
5002953
Mar
5002953*PED
Apr
5741803
Apr
5741803
Oct
5741803*PED
Feb
6288095
Aug
6288095*PED
Apr
7358366
Oct
7358366*PED

17,
17,
17,
17,
21,
21,
21,
11,
11,
19,
19,

2011
2011
2011
2012
2015
2015
2015
2017
2017
2020
2020

DS
DS
DS

DP
DP
DP

U-329
U-628
U-840

DS
DS

DP
DP

U-628
U-329

Y
Y

U-420

ROSUVASTATIN CALCIUM - CRESTOR

N021366 002 6316460
6316460*PED
6858618
6858618*PED
7030152
7030152*PED
7964614
7964614*PED
RE37314
RE37314*PED

Aug
Feb
Dec
Jun
Apr
Oct
Apr
Oct
Jan
Jul

04,
04,
17,
17,
02,
02,
02,
02,
08,
08,

2020
2021
2021
2022
2018
2018
2018
2018
2016
2016

ROSUVASTATIN CALCIUM - CRESTOR

N021366 003 6316460
6316460*PED
6858618
6858618*PED
7030152
7030152*PED
7964614
7964614*PED
RE37314
RE37314*PED

Aug
Feb
Dec
Jun
Apr
Oct
Apr
Oct
Jan
Jul

04,
04,
17,
17,
02,
02,
02,
02,
08,
08,

2020
2021
2021
2022
2018
2018
2018
2018
2016
2016

ROSUVASTATIN CALCIUM - CRESTOR

N021366 004 6316460
6316460*PED
6858618
6858618*PED
7030152
7030152*PED
7964614
7964614*PED
RE37314
RE37314*PED

Aug
Feb
Dec
Jun
Apr
Oct
Apr
Oct
Jan
Jul

04,
04,
17,
17,
02,
02,
02,
02,
08,
08,

2020
2021
2021
2022
2018
2018
2018
2018
2016
2016

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS

DS

DP
U-618
U-1032

I-621
I-611
I-573
PED
PED

Feb
Oct
Nov
Apr
May

08,
16,
06,
16,
06,

2013
2012
2011
2013
2012

I-621
I-611
I-573
PED
PED

Feb
Oct
Nov
Apr
May

08,
16,
06,
16,
06,

2013
2012
2011
2013
2012

I-621
I-611
I-573
PED
PED

Feb
Oct
Nov
Apr
May

08,
16,
06,
16,
06,

2013
2012
2011
2013
2012

U-1032
DS

DP
U-618
U-1032
U-1032
DS

DP
U-618
U-1032
U-1032
DS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 176 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ROSUVASTATIN CALCIUM - CRESTOR

N021366 005 6316460
6316460*PED
6858618
6858618*PED
7030152
7030152*PED
7964614
7964614*PED
RE37314
RE37314*PED

Aug
Feb
Dec
Jun
Apr
Oct
Apr
Oct
Jan
Jul

04,
04,
17,
17,
02,
02,
02,
02,
08,
08,

ROTIGOTINE - NEUPRO
N021829 001 6699498
6884434
7413747

Nov
Mar
Mar

27, 2020
30, 2021
18, 2019

ROTIGOTINE - NEUPRO
N021829 002 6699498
6884434
7413747

Nov
Mar
Mar

ROTIGOTINE - NEUPRO
N021829 003 6699498
6884434
7413747

2020
2021
2021
2022
2018
2018
2018
2018
2016
2016

PATENT
CODES
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-621
I-611
I-573
PED
PED

Feb
Oct
Nov
Apr
May

08,
16,
06,
16,
06,

DP
DP
DP

NCE

May

09, 2012

27, 2020
30, 2021
18, 2019

DP
DP
DP

NCE

May

09, 2012

Nov
Mar
Mar

27, 2020
30, 2021
18, 2019

DP
DP
DP

NCE

May

09, 2012

RUFINAMIDE - BANZEL
N021911 001 6740669
8076362

Nov
Jun

14, 2022
08, 2018

DS

DP
DP

NCE
ODE

Nov
Nov

14, 2013
14, 2015

RUFINAMIDE - BANZEL
N021911 002 6740669
8076362

Nov
Jun

14, 2022
08, 2018

DS

DP
DP

NCE
ODE

Nov
Nov

14, 2013
14, 2015

RUFINAMIDE - BANZEL
N021911 003 6740669
8076362

Nov
Jun

14, 2022
08, 2018

DS

DP
DP

NCE
ODE

Nov
Nov

14, 2013
14, 2015

RUFINAMIDE - BANZEL
N201367 001 6740669

Aug

17, 2020

DS

DP

NCE
ODE

Nov
Nov

14, 2013
14, 2015

RUXOLITINIB PHOSPHATE - JAKAFI

N202192 001 7598257
Dec

24, 2027

DS

DP

U-1201

NCE
ODE

Nov
Nov

16, 2016
16, 2018

RUXOLITINIB PHOSPHATE - JAKAFI

N202192 002 7598257
Dec

24, 2027

DS

DP

U-1201

NCE
ODE

Nov
Nov

16, 2016
16, 2018

RUXOLITINIB PHOSPHATE - JAKAFI

N202192 003 7598257
Dec

24, 2027

DS

DP

U-1201

NCE
ODE

Nov
Nov

16, 2016
16, 2018

RUXOLITINIB PHOSPHATE - JAKAFI

N202192 004 7598257
Dec

24, 2027

DS

DP

U-1201

NCE
ODE

Nov
Nov

16, 2016
16, 2018

RUXOLITINIB PHOSPHATE - JAKAFI

N202192 005 7598257
Dec

24, 2027

DS

DP

U-1201

NCE
ODE

Nov
Nov

16, 2016
16, 2018

U-618
U-1032

2013
2012
2011
2013
2012

U-1032
DS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 177 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

SALMETEROL XINAFOATE - SEREVENT

Sep
N020692 001 5590645*PED
Sep
5860419*PED
Feb
5873360
Aug
5873360*PED
Sep
6032666*PED
Sep
6378519*PED
Sep
6536427*PED
Sep
6792945*PED
Sep
7225808*PED
Sep
7389775*PED

01,
01,
23,
23,
01,
01,
01,
01,
01,
01,

PATENT
CODES

2011
2011
2016
2016
2011
2011
2011
2011
2011
2011

Jun
Dec
Nov
May

06,
06,
16,
16,

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP

SAPROPTERIN DIHYDROCHLORIDE - KUVAN

N022181 001 7566462
Nov 16, 2025
7566714
Nov 17, 2024
7612073
Nov 17, 2024
7727987
Nov 17, 2024
7947681
Nov 17, 2024
8003126
Nov 16, 2025
8067416
Nov 17, 2024
SAQUINAVIR - FORTOVASE
N020828 001 6008228
6008228*PED
6352717
6352717*PED

PATENT
DELIST
REQUESTED

DP
U-989
U-1010

NCE
ODE

Dec
Dec

13, 2012
13, 2014

DP
U-1156
U-989

2015
2015
2019
2020

SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA

N022350 001 6395767
Feb 16, 2021
7951400
Nov 30, 2028

DS

DP
DP

U-995

M-108
NCE

Dec
Jul

16, 2013
31, 2014

SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA

N022350 002 6395767
Feb 16, 2021
7951400
Nov 30, 2028

DS

DP
DP

U-995

M-108
NCE

Dec
Jul

16, 2013
31, 2014

SELEGILINE - EMSAM
N021336 001 7070808
7150881
7638140

May
Jun
May

10, 2018
12, 2018
10, 2018

DS
DS

DP
DP
DP

SELEGILINE - EMSAM
N021336 002 7070808
7150881
7638140

May
Jun
May

10, 2018
12, 2018
10, 2018

DS
DS

DP
DP
DP

SELEGILINE - EMSAM
N021336 003 7070808
7150881
7638140

May
Jun
May

10, 2018
12, 2018
10, 2018

DS
DS

DP
DP
DP

SELEGILINE HYDROCHLORIDE - ZELAPAR

N021479 001 5648093
Jul
6423342
Mar

15, 2014
01, 2016

SERTACONAZOLE NITRATE - ERTACZO

N021385 001 5135943
May

31, 2014

SERTRALINE HYDROCHLORIDE - ZOLOFT

Aug
N019839 001 5248699
Feb
5248699*PED

13, 2012
13, 2013

SERTRALINE HYDROCHLORIDE - ZOLOFT

Aug
N019839 002 5248699
Feb
5248699*PED

13, 2012
13, 2013

SERTRALINE HYDROCHLORIDE - ZOLOFT

Aug
N019839 003 5248699
Feb
5248699*PED

13, 2012
13, 2013

DP
DP

DS

DP

U-786

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 178 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

SERTRALINE HYDROCHLORIDE - ZOLOFT

Aug
N019839 004 5248699
Feb
5248699*PED

13, 2012
13, 2013

SERTRALINE HYDROCHLORIDE - ZOLOFT

Aug
N019839 005 5248699
Feb
5248699*PED

13, 2012
13, 2013

SERTRALINE HYDROCHLORIDE - ZOLOFT

Aug
N020990 001 5248699
Feb
5248699*PED
Oct
6727283
Apr
6727283*PED
Nov
7067555
May
7067555*PED

13,
13,
11,
11,
10,
10,

2012
2013
2019
2020
2019
2020

SEVELAMER CARBONATE - RENVELA

N022127 001 5496545
5667775
6509013
6858203
7014846
7459151
7985418

Aug
Sep
Aug
Aug
Aug
Aug
Oct

11,
16,
11,
11,
11,
11,
27,

2013
2014
2013
2013
2013
2013
2025

DP

SEVELAMER CARBONATE - RENVELA

N022318 001 5496545
5667775
6509013
6858203
7014846
7459151

Aug
Sep
Aug
Aug
Aug
Aug

11,
16,
11,
11,
11,
11,

2013
2014
2013
2013
2013
2013

DP

SEVELAMER CARBONATE - RENVELA

N022318 002 5496545
5667775
6509013
6858203
7014846
7459151

Aug
Sep
Aug
Aug
Aug
Aug

11,
16,
11,
11,
11,
11,

2013
2014
2013
2013
2013
2013

DP

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-580

DP

DP
DP
DP

U-246
U-246
U-246
U-246
U-246

DP

DP
DP
DP

DP
DP
DP

U-246
U-246

U-246
U-246
U-246
U-246
U-246

11, 2013
16, 2014
11, 2013

U-246
U-246

SEVELAMER HYDROCHLORIDE - RENAGEL

N021179 001 5496545
Aug
Sep
5667775
Aug
6509013
Oct
6733780
Aug
7014846
Aug
7459151

11,
16,
11,
18,
11,
11,

2013
2014
2013
2020
2013
2013

U-246
U-246

SEVELAMER HYDROCHLORIDE - RENAGEL

Aug
N021179 002 5496545
Sep
5667775
Aug
6509013
Oct
6733780
Aug
7014846
Aug
7459151

11,
16,
11,
18,
11,
11,

2013
2014
2013
2020
2013
2013

U-246
U-246

U-246
U-246
DP
DP

Aug

12, 2012

NDF

Aug

12, 2012

U-246
U-246
U-246

SEVELAMER HYDROCHLORIDE - RENAGEL

N020926 001 5496545
Aug
5667775
Sep
6509013
Aug

DP
DP

NDF

U-246
U-246

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 179 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

SEVOFLURANE - ULTANE
N020478 001 5990176
5990176*PED
6074668
6074668*PED
6288127
6288127*PED
6444859
6444859*PED

PATENT
EXPIRATION
DATE

Jan
Jul
Jan
Jul
Jan
Jul
Jan
Jul

27,
27,
09,
09,
27,
27,
27,
27,

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

2017
2017
2018
2018
2017
2017
2017
2017

SIBUTRAMINE HYDROCHLORIDE - MERIDIA

N020632 001 5436272
Jul 25, 2012
5436272*PED
Jan 25, 2013

U-439

SIBUTRAMINE HYDROCHLORIDE - MERIDIA

N020632 002 5436272
Jul 25, 2012
5436272*PED
Jan 25, 2013

U-439

SIBUTRAMINE HYDROCHLORIDE - MERIDIA

N020632 003 5436272
Jul 25, 2012
5436272*PED
Jan 25, 2013

U-439

SILDENAFIL CITRATE - REVATIO

N021845 001 5250534

Mar

27, 2012

DS

DP

I-598

May

07, 2012

SILDENAFIL CITRATE - REVATIO

N022473 001 5250534

Mar

27, 2012

DS

DP

NDF

Nov

20, 2012

SILDENAFIL CITRATE - VIAGRA

N020895 001 5250534
6469012

Mar
Oct

27, 2012
22, 2019

U-155

SILDENAFIL CITRATE - VIAGRA

N020895 002 5250534
6469012

Mar
Oct

27, 2012
22, 2019

U-155

SILDENAFIL CITRATE - VIAGRA

N020895 003 5250534
6469012

Mar
Oct

27, 2012
22, 2019

U-155

SILODOSIN - RAPAFLO
N022206 001 5387603
5403847
5780485
6015819

Dec
Nov
Nov
Nov

01,
13,
13,
13,

2018
2012
2012
2012

DS

NCE

Oct

08, 2013

SILODOSIN - RAPAFLO
N022206 002 5387603
5403847
5780485
6015819

Dec
Nov
Nov
Nov

01,
13,
13,
13,

2018
2012
2012
2012

DS

NCE

Oct

08, 2013

SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC

Apr 24, 2017
N202343 001 6303661
Jul 26, 2022
6699871
Feb 02, 2019
6890898
Feb 02, 2019
6890898
Feb 02, 2019
6890898
Feb 02, 2019
7078381
Jul 26, 2022
7125873
Jul 26, 2022
7125873
Jul 26, 2022
7125873
Jul 26, 2022
7125873
Apr 11, 2026
7326708
Feb 02, 2019
7459428

DP
U-902
U-902
U-902

DP
U-902
U-902
U-902

U-1188
DS

DS

DP

DP
DP
DP
DP
DP

U-1190
U-1189
U-1191
U-1188
U-1190
U-1189
U-1192
U-1193
U-1188
U-1189

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 180 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC

N202343 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
Feb 02, 2019
7459428
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N202343 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
Feb 02, 2019
7459428
SINCALIDE - KINEVAC
N017697 001 6803046

Aug

16, 2022

SINECATECHINS - VEREGEN
N021902 001 5795911
5968973
7858662

Oct
Apr
Oct

31, 2020
10, 2017
02, 2026

SIROLIMUS - RAPAMUNE
N021083 001 5100899
5100899*PED
5403833
5403833*PED
5536729
5536729*PED

Jul
Jan
Apr
Oct
Sep
Mar

07,
07,
04,
04,
30,
30,

2013
2014
2012
2012
2013
2014

SIROLIMUS - RAPAMUNE
N021110 001 5100899
5100899*PED
5145684*PED
5403833
5403833*PED
5989591
5989591*PED

Jul
Jan
Jul
Apr
Oct
Mar
Sep

07,
07,
25,
04,
04,
11,
11,

2013
2014
2011
2012
2012
2018
2018

SIROLIMUS - RAPAMUNE
N021110 002 5100899
5100899*PED
5145684*PED
5403833
5403833*PED
5989591
5989591*PED

Jul
Jan
Jul
Apr
Oct
Mar
Sep

07,
07,
25,
04,
04,
11,
11,

2013
2014
2011
2012
2012
2018
2018

SIROLIMUS - RAPAMUNE
N021110 003 5100899
5100899*PED
5145684*PED
5403833
5403833*PED
5989591
5989591*PED

Jul
Jan
Jul
Apr
Oct
Mar
Sep

07,
07,
25,
04,
04,
11,
11,

2013
2014
2011
2012
2012
2018
2018

PATENT
CODES
U-1188
DS

DP

DS

DP
DP
DP
DP
DP

DS

DP

U-1190
U-1189
U-1191
U-1188
U-1193
U-1190
U-1192
U-1189
U-1188
U-1189

U-1188

DS

DP
DP
DP
DP
DP

U-1190
U-1191
U-1189
U-1188
U-1192
U-1189
U-1193
U-1190
U-1188
U-1189

DP

DP

U-172
U-172
U-172

U-290
U-293
DP

U-290

U-293
DP

U-290

U-293
DP

U-290

U-293
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 181 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

SIROLIMUS - RAPAMUNE
N021110 004 5100899
5100899*PED
5145684*PED
5403833
5403833*PED
5989591
5989591*PED

PATENT
EXPIRATION
DATE

Jul
Jan
Jul
Apr
Oct
Mar
Sep

07,
07,
25,
04,
04,
11,
11,

2013
2014
2011
2012
2012
2018
2018

SITAGLIPTIN PHOSPHATE - JANUVIA

N021995 001 6303661
Apr
6699871
Jul
6890898
Feb
6890898
Feb
6890898
Feb
7078381
Feb
7078381
Feb
7078381
Feb
7078381
Feb
7125873
Jul
7125873
Jul
7125873
Jul
7125873
Jul
7326708
Apr

24,
26,
02,
02,
02,
02,
02,
02,
02,
26,
26,
26,
26,
11,

2017
2022
2019
2019
2019
2019
2019
2019
2019
2022
2022
2022
2022
2026

SITAGLIPTIN PHOSPHATE - JANUVIA

N021995 002 6303661
Apr
6699871
Jul
6890898
Feb
6890898
Feb
6890898
Feb
7078381
Feb
7078381
Feb
7078381
Feb
7078381
Feb
7125873
Jul
7125873
Jul
7125873
Jul
7125873
Jul
7326708
Apr

24,
26,
02,
02,
02,
02,
02,
02,
02,
26,
26,
26,
26,
11,

2017
2022
2019
2019
2019
2019
2019
2019
2019
2022
2022
2022
2022
2026

SITAGLIPTIN PHOSPHATE - JANUVIA

N021995 003 6303661
Apr
6699871
Jul
6890898
Feb
6890898
Feb
6890898
Feb
7078381
Feb
7078381
Feb
7078381
Feb
7078381
Feb
7125873
Jul
7125873
Jul
7125873
Jul
7125873
Jul
7326708
Apr

24,
26,
02,
02,
02,
02,
02,
02,
02,
26,
26,
26,
26,
11,

2017
2022
2019
2019
2019
2019
2019
2019
2019
2022
2022
2022
2022
2026

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-290

U-293
DP

U-774
U-774
U-775
U-1039
U-1036
U-775
U-1036
U-1037
U-1038
U-775
U-1036
U-1037
U-1038
U-802

NCE

Oct

16, 2011

U-774
U-774
U-1039
U-1036
U-775
U-775
U-1038
U-1037
U-1036
U-1038
U-1036
U-1037
U-775
U-802

NCE

Oct

16, 2011

U-774
U-774
U-1039
U-1036
U-775
U-1037
U-1036
U-1038
U-775
U-1037
U-1038
U-1036
U-775
U-802

NCE

Oct

16, 2011

SODIUM BENZOATE; SODIUM PHENYLACETATE - AMMONUL

N020645 001

ODE

Feb

17, 2012

SODIUM NITRITE; SODIUM THIOSULFATE - NITHIODOTE

N201444 001

ODE

Jan

14, 2018

DS

DP

DS

DP

DS

DP

DS

DP

DS

DP

DS

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 182 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

SODIUM OXYBATE - XYREM

N021196 001 6780889
7262219
7668730
7765106
7765107
7851506
7851506
7895059

PATENT
EXPIRATION
DATE

Jul
Jul
Jun
Jun
Jun
Dec
Dec
Dec

04,
04,
16,
16,
16,
22,
22,
17,

PATENT
CODES

2020
2020
2024
2024
2024
2019
2019
2022

DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)
ODE

U-1110
U-1069
U-1070
U-1102
U-1101
U-1110

SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - VISICOL

N021097 001 5616346
May 18, 2013
U-359
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - OSMOPREP
N021892 001 5616346
May 18, 2013
DP U-715

7687075
Jun 22, 2028
DS DP

SOLIFENACIN SUCCINATE - VESICARE

N021518 001 6017927
Nov

19, 2018

DS

DP

SOLIFENACIN SUCCINATE - VESICARE

N021518 002 6017927
Nov

19, 2018

DS

DP

SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE

N020280 001 5435076
Apr 16, 2013
DP
DP
5501673
Apr 16, 2013
DP
5716338
Feb 10, 2015
DP
6152897
Nov 20, 2018
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 002 5435076
Apr 16, 2013
DP
DP
5501673
Apr 16, 2013
DP
5716338
Feb 10, 2015
6152897
Nov 20, 2018
DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 003 5435076
Apr 16, 2013
DP
DP
5501673
Apr 16, 2013
5716338
Feb 10, 2015
DP
DP
6152897
Nov 20, 2018
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 005 5435076
Apr 16, 2013
DP
5501673
Apr 16, 2013
DP
DP
5716338
Feb 10, 2015
DP
6152897
Nov 20, 2018
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 008 5435076
Apr 16, 2013
DP
DP
5501673
Apr 16, 2013
DP
5716338
Feb 10, 2015
DP
6152897
Nov 20, 2018
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 009 5435076
Apr 16, 2013
DP
DP
5501673
Apr 16, 2013
DP
5716338
Feb 10, 2015
6152897
Nov 20, 2018
DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 010 5435076
Apr 16, 2013
DP
5501673
Apr 16, 2013
DP
DP
5716338
Feb 10, 2015
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 011 5435076
Apr 16, 2013
DP
5501673
Apr 16, 2013
DP
DP
5716338
Feb 10, 2015

EXCLUSIVITY
EXPIRATION
DATE

Nov

18, 2012

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 183 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE

DP
N020280 012 5435076
Apr 16, 2013
DP
5501673
Apr 16, 2013
DP
Feb 10, 2015
5716338
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N020280 013 5435076
Apr 16, 2013
DP
DP
5501673
Apr 16, 2013
DP
5716338
Feb 10, 2015
SOMATROPIN RECOMBINANT - HUMATROPE
N019640 001
SOMATROPIN RECOMBINANT - HUMATROPE
N019640 004
SOMATROPIN RECOMBINANT - HUMATROPE
N019640 005
SOMATROPIN RECOMBINANT - HUMATROPE
N019640 006
SOMATROPIN RECOMBINANT - HUMATROPE
N019640 007

I-585
ODE

Mar
Nov

12, 2012
01, 2013

I-585
ODE

Mar
Nov

12, 2012
01, 2013

I-585
ODE

Mar
Nov

12, 2012
01, 2013

I-585
ODE

Mar
Nov

12, 2012
01, 2013

I-585
ODE

Mar
Nov

12, 2012
01, 2013

SOMATROPIN RECOMBINANT - NORDITROPIN

N021148 001 5849700
Dec 15, 2015
5849704
Dec 15, 2015

U-340

I-572
ODE

Oct
May

31, 2011
31, 2014

SOMATROPIN RECOMBINANT - NORDITROPIN

N021148 002 5849700
Dec 15, 2015
5849704
Dec 15, 2015

U-340

I-572
ODE

Oct
May

31, 2011
31, 2014

U-340

I-572
ODE

Oct
May

31, 2011
31, 2014

SOMATROPIN RECOMBINANT - NORDITROPIN

N021148 003 5633352
May 27, 2014
Dec 15, 2015
5849700
Dec 15, 2015
5849704
SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO
N021148 008 5849700
Dec 15, 2015
5849704
Dec 15, 2015

DP

U-1041
U-1041

I-572
ODE

Oct
May

31, 2011
31, 2014

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO

N021148 009 5849700
Dec 15, 2015
5849704
Dec 15, 2015

DP

U-1041
U-1041

I-572
ODE

Oct
May

31, 2011
31, 2014

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO

N021148 010 5849700
Dec 15, 2015
5849704
Dec 15, 2015

DP

U-1041
U-1041

I-572
ODE

Oct
May

31, 2011
31, 2014

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

N021148 004 5849700
Dec 15, 2015
5849704
Dec 15, 2015

DP

U-340
U-340

I-572
ODE

Oct
May

31, 2011
31, 2014

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

N021148 005 5849700
Dec 15, 2015
5849704
Dec 15, 2015

DP

U-340
U-340

I-572
ODE

Oct
May

31, 2011
31, 2014

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

N021148 006 5849700
Dec 15, 2015
5849704
Dec 15, 2015

DP

U-340
U-340

I-572
ODE

Oct
May

31, 2011
31, 2014

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 184 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX

N021148 007 5849700
Dec 15, 2015
5849704
Dec 15, 2015

DP

SOMATROPIN RECOMBINANT - NUTROPIN AQ

N020522 001 5763394
Jun 09, 2015

DP

SOMATROPIN RECOMBINANT - NUTROPIN AQ PEN

N020522 002 5763394
Jun 09, 2015

DP

U-340
U-340

SOMATROPIN RECOMBINANT - NUTROPIN DEPOT

N021075 001 5654010
Aug 05,
5656297
Jul 25,
5912015
Mar 12,
6051259
Dec 02,

2014
2014
2012
2012

U-340

SOMATROPIN RECOMBINANT - NUTROPIN DEPOT

N021075 002 5654010
Aug 05,
5656297
Jul 25,
5912015
Mar 12,
6051259
Dec 02,

2014
2014
2012
2012

U-340

SOMATROPIN RECOMBINANT - NUTROPIN DEPOT

Aug 05,
N021075 003 5654010
Jul 25,
5656297
Mar 12,
5912015
Dec 02,
6051259

2014
2014
2012
2012

U-340

SOMATROPIN RECOMBINANT - SAIZEN

N019764 002 5898030
Apr

27, 2016

DP

SOMATROPIN RECOMBINANT - SAIZEN

Apr
N019764 003 5898030

27, 2016

DP

SOMATROPIN RECOMBINANT - SEROSTIM

Apr
N020604 001 5898030

27, 2016

DP

SOMATROPIN RECOMBINANT - SEROSTIM

Apr
N020604 002 5898030

27, 2016

DP

SOMATROPIN RECOMBINANT - SEROSTIM

Apr
N020604 003 5898030

27, 2016

DP

SOMATROPIN RECOMBINANT - SEROSTIM

Apr
N020604 004 5898030

27, 2016

DP

SOMATROPIN RECOMBINANT - ZORBTIVE

Oct
N021597 004 5288703
Apr
5898030

07, 2011
27, 2016

DP

SORAFENIB TOSYLATE - NEXAVAR

N021923 001 7235576
7351834
7897623

12, 2020
12, 2020
12, 2020

Jan
Jan
Jan

Mar
Jun
Jun
Jul

05,
22,
22,
02,

STAVUDINE - ZERIT XR
N021453 001 7135465
7135465*PED

Feb
Aug

18, 2023
18, 2023

2013
2019
2019
2021

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-572
ODE

Oct
May

31, 2011
31, 2014

ODE
ODE

Nov
Dec

16, 2014
20, 2012

ODE

Jul

02, 2016

NCE

Jan

18, 2016

U-898

DS
DS

DP
DP

SOTALOL HYDROCHLORIDE - SOTALOL HYDROCHLORIDE

N022306 001
SPINOSAD - NATROBA
N022408 001 5496931
6063771
6342482
7030095

PATENT
DELIST
REQUESTED

DS
DP
DP
DP

U-1105
U-1105
U-1105
U-1105

DP

U-167

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 185 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

STAVUDINE - ZERIT XR
N021453 002 7135465
7135465*PED

Feb
Aug

18, 2023
18, 2023

DP

U-167

STAVUDINE - ZERIT XR
N021453 003 7135465
7135465*PED

Feb
Aug

18, 2023
18, 2023

DP

U-167

STAVUDINE - ZERIT XR
N021453 004 7135465
7135465*PED

Feb
Aug

18, 2023
18, 2023

DP

U-167

SUMATRIPTAN - IMITREX
N020626 001 5307953
5307953*PED
5554639
5554639*PED
5705520
5705520*PED

Dec
Jun
Sep
Mar
Dec
Jun

02,
02,
10,
10,
10,
10,

2012
2013
2013
2014
2011
2012

SUMATRIPTAN - IMITREX
N020626 002 5307953
5307953*PED
5554639
5554639*PED
5705520
5705520*PED

Dec
Jun
Sep
Mar
Dec
Jun

02,
02,
10,
10,
10,
10,

2012
2013
2013
2014
2011
2012

SUMATRIPTAN - IMITREX
N020626 003 5307953
5307953*PED
5554639
5554639*PED
5705520
5705520*PED

Dec
Jun
Sep
Mar
Dec
Jun

02,
02,
10,
10,
10,
10,

2012
2013
2013
2014
2011
2012

SUMATRIPTAN SUCCINATE - ALSUMA

N022377 001 7811254
Aug

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-232
U-232

U-232
U-232

U-232
U-232

26, 2027

SUMATRIPTAN SUCCINATE - SUMAVEL DOSEPRO

N022239 001 5891086
Jul 27,
5957886
Mar 08,
6135979
Mar 21,
7776007
Nov 28,
7901385
Jul 31,

PATENT
DELIST
REQUESTED

DP

U-1083

DP
DP
DP
DP
DP

2014
2016
2017
2026
2026

SUNITINIB MALATE - SUTENT

N021938 001 6573293
7125905
7211600

Feb
Feb
Dec

15, 2021
15, 2021
22, 2020

DS
DS

SUNITINIB MALATE - SUTENT

N021938 002 6573293
7125905
7211600

Feb
Feb
Dec

15, 2021
15, 2021
22, 2020

DS
DS

SUNITINIB MALATE - SUTENT

N021938 003 6573293
7125905
7211600

Feb
Feb
Dec

15, 2021
15, 2021
22, 2020

DS
DS

SUNITINIB MALATE - SUTENT

N021938 004 6573293
7125905
7211600

Feb
Feb
Dec

15, 2021
15, 2021
22, 2020

DS
DS

DP
DP

U-1154

I-639

May

20, 2014

I-639

May

20, 2014

I-639

May

20, 2014

I-639

May

20, 2014

TACROLIMUS - PROGRAF
N050708 001

ODE

Mar

29, 2013

TACROLIMUS - PROGRAF
N050708 002

ODE

Mar

29, 2013

U-883

DP
DP

U-1154
U-883

DP
DP

U-1154
U-883

DP
DP

U-1154
U-883

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 186 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

TACROLIMUS - PROGRAF
N050708 003

ODE

Mar

29, 2013

TACROLIMUS - PROGRAF
N050709 001

ODE

Mar

29, 2013

NP
ODE

May
May

22, 2012
22, 2016

I-642
I-641

Oct
Oct

07, 2014
07, 2014

I-642
I-641

Oct
Oct

07, 2014
07, 2014

I-642
I-641

Oct
Oct

07, 2014
07, 2014

I-642
I-641

Oct
Oct

07, 2014
07, 2014

M-54
PED

Dec
Jun

22, 2012
22, 2013

NCE

Nov

20, 2013

TACROLIMUS - PROTOPIC
N050777 001 5385907
5665727

Jan
Sep

31, 2012
09, 2014

DP

TACROLIMUS - PROTOPIC
N050777 002 5385907
5665727

Jan
Sep

31, 2012
09, 2014

DP

TADALAFIL - ADCIRCA
N022332 001 5859006
6821975
7182958

Nov
Nov
Apr

21, 2017
19, 2020
26, 2020

DS
DS

DP
DP
DP

TADALAFIL - CIALIS
N021368 001 5859006
6140329
6140329
6821975
6821975
6821975
6943166
6943166
6943166
7182958
7182958

Nov
Jul
Jul
Nov
Nov
Nov
Apr
Apr
Apr
Apr
Apr

21,
11,
11,
19,
19,
19,
26,
26,
26,
26,
26,

2017
2016
2016
2020
2020
2020
2020
2020
2020
2020
2020

DS

DP
DP
DP
DP
DP
DP

TADALAFIL - CIALIS
N021368 002 5859006
6140329
6821975
6821975
6943166
6943166
7182958

Nov
Jul
Nov
Nov
Apr
Apr
Apr

21,
11,
19,
19,
26,
26,
26,

2017
2016
2020
2020
2020
2020
2020

DS

TADALAFIL - CIALIS
N021368 003 5859006
6140329
6821975
6821975
6943166
7182958

Nov
Jul
Nov
Nov
Apr
Apr

21,
11,
19,
19,
26,
26,

2017
2016
2020
2020
2020
2020

DS

TADALAFIL - CIALIS
N021368 004 5859006
6140329
6821975
6821975
6943166
7182958

Nov
Jul
Nov
Nov
Apr
Apr

21,
11,
19,
19,
26,
26,

2017
2016
2020
2020
2020
2020

DS

TAMOXIFEN CITRATE - SOLTAMOX

N021807 001 6127425

Jun

26, 2018

U-919

U-919

DS
DS
DS

DP
DP

DS
DS

DP
DP
DP
DP

DP

DS
DS

DP
DP
DP
DP
DP

DS
DS

DP
DP
DP
DP
DP

U-975

U-155
U-1184
U-533
U-614
U-1184
U-155
U-1184
U-614
U-1184
U-155

U-155
U-614
U-533
U-155
U-614
U-155

U-155
U-533
U-614
U-614
U-155

U-155
U-614
U-533
U-155
U-155

DP

TAMSULOSIN HYDROCHLORIDE - FLOMAX

N020579 001
TAPENTADOL HYDROCHLORIDE - NUCYNTA
N022304 001 6071970
Jun
7994364
Jun
RE39593
Aug

06, 2017
27, 2025
05, 2022

DS
DS

DP
DP

U-931
U-931
U-931

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 187 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

TAPENTADOL HYDROCHLORIDE - NUCYNTA

N022304 002 6071970
Jun
7994364
Jun
RE39593
Aug

06, 2017
27, 2025
05, 2022

Nov

20, 2013

DP
DP

U-931
U-931
U-931

NCE

DS
DS

TAPENTADOL HYDROCHLORIDE - NUCYNTA

N022304 003 6071970
Jun
7994364
Jun
RE39593
Aug

06, 2017
27, 2025
05, 2022

Nov

20, 2013

DP
DP

U-931
U-931
U-931

NCE

DS
DS

DS

DP
DP
DP

U-1178
U-1178

NDF
NCE

Aug
Nov

25, 2014
20, 2013

NDF
NCE

Aug
Nov

25, 2014
20, 2013

NDF
NCE

Aug
Nov

25, 2014
20, 2013

NDF
NCE

Aug
Nov

25, 2014
20, 2013

NDF
NCE

Aug
Nov

25, 2014
20, 2013

PED

Oct

30, 2011

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N200533 001 6071970
Jun 06,
7994364
Jun 27,
8075872
Nov 20,
RE39593
Aug 05,

2017
2025
2023
2022

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N200533 002 6071970
Jun 06,
7994364
Jun 27,
8075872
Nov 20,
RE39593
Aug 05,

2017
2025
2023
2022

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N200533 003 6071970
Jun 06,
7994364
Jun 27,
8075872
Nov 20,
RE39593
Aug 05,

2017
2025
2023
2022

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N200533 004 6071970
Jun 06,
7994364
Jun 27,
8075872
Nov 20,
RE39593
Aug 05,

2017
2025
2023
2022

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER

N200533 005 6071970
Jun 06,
7994364
Jun 27,
8075872
Nov 20,
RE39593
Aug 05,

2017
2025
2023
2022

DS

DS
DS

DS
DS

DS
DS

DS
DS

DP
DP
DP

DP
DP
DP

DP
DP
DP

DP
DP
DP

U-1178

U-1178
U-1178
U-1178

U-1178
U-1178
U-1178

U-1178
U-1178
U-1178

U-1178
U-1178
U-1178

TAZAROTENE - TAZORAC
N020600 001 5914334
6258830

Jun
Jun

07, 2014
07, 2014

U-517
U-517

TAZAROTENE - TAZORAC
N020600 002 5914334
6258830

Jun
Jun

07, 2014
07, 2014

U-517
U-517

TECHNETIUM TC-99M APCITIDE - ACUTECT

N020887 001 5443815
Aug 22, 2012
5508020
Apr 16, 2013
5645815
Jul 08, 2014
TECHNETIUM TC-99M BICISATE KIT - NEUROLITE
N020256 001 5431900
Jul 11, 2012
TECHNETIUM TC-99M MERTIATIDE KIT - TECHNESCAN MAG3
N019882 001 5573748
Nov 12, 2013

U-336

DP

TECHNETIUM TC-99M SESTAMIBI KIT - CARDIOLITE

N019785 001
TECHNETIUM TC-99M TEBOROXIME KIT - CARDIOTEC
N019928 001 6056941
Jul 28, 2019

DP

TEGASEROD MALEATE - ZELNORM

N021200 001 5510353

Apr

26, 2013

U-466

TEGASEROD MALEATE - ZELNORM

N021200 002 5510353

Apr

26, 2013

U-466

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 188 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

TELAPREVIR - INCIVEK
N201917 001 7820671

PATENT
EXPIRATION
DATE

PATENT
CODES

25, 2025

DS

DP

TELAVANCIN HYDROCHLORIDE - VIBATIV

Sep
N022110 001 6635618
Aug
6858584
Jun
6872701
May
7008923
May
7208471
May
7351691
Jan
7531623
May
7544364
May
7700550

22,
24,
05,
06,
01,
01,
01,
01,
01,

2021
2022
2021
2021
2021
2021
2027
2021
2021

DS

DP
DP
DP

DS
DS
DS

DP
DP

TELAVANCIN HYDROCHLORIDE - VIBATIV

Sep
N022110 002 6635618
Aug
6858584
Jun
6872701
May
7008923
May
7208471
May
7351691
Jan
7531623
May
7544364
May
7700550

22,
24,
05,
06,
01,
01,
01,
01,
01,

2021
2022
2021
2021
2021
2021
2027
2021
2021

DS

DP
DP
DP

DS
DS
DS

DP
DP

TELBIVUDINE - TYZEKA
N022011 001 6395716
6444652
6566344
6569837
6569837
7589079
7795238
7858594

Aug
Aug
Aug
Oct
Oct
Sep
Aug
Sep

10,
10,
10,
25,
25,
11,
10,
11,

2019
2019
2019
2020
2020
2023
2019
2023

TELBIVUDINE - TYZEKA
N022154 001 6395716
6444652
6566344
6569837
7795238

Aug
Aug
Aug
Oct
Aug

10,
10,
10,
25,
10,

2019
2019
2019
2020
2019

TELITHROMYCIN - KETEK
N021144 001 5635485
D459798

Apr
Sep

01, 2018
24, 2015

DS

DP
DP

U-578

TELITHROMYCIN - KETEK
N021144 002 5635485
D459798

Apr
Sep

01, 2018
24, 2015

DS

DP
DP

U-578

TELMISARTAN - MICARDIS
N020850 001 5591762
6358986

Jan
Jan

07, 2014
10, 2020

TELMISARTAN - MICARDIS
N020850 002 5591762
6358986
7998953
8003679

Jan
Jan
Jun
Oct

07,
10,
06,
06,

TELMISARTAN - MICARDIS
N020850 003 5591762
6358986

Jan
Jan

07, 2014
10, 2020

TEMOZOLOMIDE - TEMODAR
N021029 001 5260291
5260291*PED

Aug
Feb

11, 2013
11, 2014

Feb

2014
2020
2020
2022

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

May

23, 2016

NCE

Sep

11, 2014

NCE

Sep

11, 2014

U-782
U-782
U-782
U-999
U-782
U-999
U-999
U-999

NCE

Oct

25, 2011

U-999
U-999
U-999
U-999
U-999

NCE

Oct

25, 2011

I-612

Oct

16, 2012

ODE

Mar

15, 2012

U-728

U-1005
U-728

DP
U-282

U-728

U-1005
U-728

DP
U-282

DS

DP

DS

DP

U-3

DS

DP

U-3
U-1177
U-1176

U-3

DS

DP

U-619

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 189 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

TEMOZOLOMIDE - TEMODAR
N021029 002 5260291
5260291*PED

Aug
Feb

11, 2013
11, 2014

DS

DP

U-619

ODE

Mar

15, 2012

TEMOZOLOMIDE - TEMODAR
N021029 003 5260291
5260291*PED

Aug
Feb

11, 2013
11, 2014

DS

DP

U-619

ODE

Mar

15, 2012

TEMOZOLOMIDE - TEMODAR
N021029 004 5260291
5260291*PED

Aug
Feb

11, 2013
11, 2014

DS

DP

U-619

ODE

Mar

15, 2012

TEMOZOLOMIDE - TEMODAR
N021029 005 5260291
5260291*PED

Aug
Feb

11, 2013
11, 2014

DS

DP

U-619

ODE

Mar

15, 2012

TEMOZOLOMIDE - TEMODAR
N021029 006 5260291
5260291*PED

Aug
Feb

11, 2013
11, 2014

DS

DP

U-619

ODE

Mar

15, 2012

TEMOZOLOMIDE - TEMODAR
N022277 001 5260291
5260291*PED
6987108
7786118

Aug
Feb
Sep
Feb

11,
11,
08,
21,

2013
2014
2023
2023

DS

DP

U-619

TEMSIROLIMUS - TORISEL
N022088 001 5362718
8026276

Apr
Jan

18, 2014
20, 2026

DS

M-92
M-91
NCE
ODE

Jul
Apr
May
May

09,
26,
30,
30,

2013
2013
2012
2014

I-569
M-95
NPP
ODE
PED
PED
PED
PED

Aug
Oct
Mar
Mar
Feb
Apr
Sep
Sep

11,
01,
24,
24,
11,
01,
24,
24,

2011
2013
2013
2017
2012
2014
2013
2017

TENOFOVIR DISOPROXIL FUMARATE - VIREAD

N021356 001 5922695
Jul 25,
5922695
Jul 25,
5922695
Jul 25,
5922695
Jul 25,
5922695*PED
Jan 25,
5935946
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5935946
Jul 25,
5935946*PED
Jan 25,
5977089
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
5977089
Jul 25,
5977089*PED
Jan 25,
6043230
Jul 25,
6043230
Jul 25,
6043230
Jul 25,
6043230
Jul 25,
6043230*PED
Jan 25,

2017
2017
2017
2017
2018
2017
2017
2017
2017
2018
2017
2017
2017
2017
2018
2017
2017
2017
2017
2018

DP
DP

DP
DP

DS
DS
DS
DS

U-999
U-248
U-250
U-256

DS
DS
DS
DS

DP
DP
DP
DP

U-250
U-999
U-256
U-248

DS
DS
DS
DS

DP
DP
DP
DP

U-250
U-248
U-256
U-999
U-250
U-256
U-999
U-248

TERAZOSIN HYDROCHLORIDE - HYTRIN

N019057 001 5294615
Apr
5294615
Apr
5412095
Apr

29, 2013
29, 2013
29, 2013

U-3
U-165

TERAZOSIN HYDROCHLORIDE - HYTRIN

Apr
N019057 002 5294615
Apr
5294615
Apr
5412095

29, 2013
29, 2013
29, 2013

U-165
U-3

TERAZOSIN HYDROCHLORIDE - HYTRIN

N019057 003 5294615
Apr
5294615
Apr
5412095
Apr

29, 2013
29, 2013
29, 2013

U-165
U-3

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 190 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

TERAZOSIN HYDROCHLORIDE - HYTRIN

Apr
N019057 004 5294615
Apr
5294615
Apr
5412095

29, 2013
29, 2013
29, 2013

U-3
U-165

TERAZOSIN HYDROCHLORIDE - HYTRIN

N020347 001 5294615
Apr
5294615
Apr
Apr
5412095

29, 2013
29, 2013
29, 2013

U-165
U-3

TERAZOSIN HYDROCHLORIDE - HYTRIN

Apr
N020347 002 5294615
Apr
5294615
Apr
5412095

29, 2013
29, 2013
29, 2013

U-165
U-3

TERAZOSIN HYDROCHLORIDE - HYTRIN

N020347 003 5294615
Apr
5294615
Apr
Apr
5412095

29, 2013
29, 2013
29, 2013

U-3
U-165

TERAZOSIN HYDROCHLORIDE - HYTRIN

Apr
N020347 004 5294615
Apr
5294615
Apr
5412095

29, 2013
29, 2013
29, 2013

U-3
U-165

TERBINAFINE - LAMISIL
N020846 001 5681849
5681849*PED
5856355
5856355
5856355
5856355*PED
6005001
6005001
6005001
6005001*PED

Oct
Apr
May
May
May
Nov
May
May
May
Nov

28,
28,
18,
18,
18,
18,
18,
18,
18,
18,

2014
2015
2012
2012
2012
2012
2012
2012
2012
2012

DP

TERBINAFINE - LAMISIL AT
N021958 001 5681849
5681849*PED
5856355
5856355
5856355*PED

Oct
Apr
May
May
Nov

28,
28,
18,
18,
18,

2014
2015
2012
2012
2012

DP

DP
DP
DP

U-502
U-504
U-540

DP
DP
DP

U-502
U-540
U-504

DP
DP

U-540
U-504

U-597
U-597

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

TERBINAFINE HYDROCHLORIDE - LAMISIL AT

Oct 28, 2014
N021124 001 5681849
Apr 28, 2015
5681849*PED
TERBINAFINE HYDROCHLORIDE - LAMISIL AT
Oct 28, 2014
N021124 002 5681849
Apr 28, 2015
5681849*PED
TERIPARATIDE RECOMBINANT HUMAN - FORTEO
Dec 08,
N021318 001 6770623
Aug 19,
6977077
Dec 08,
7144861
Aug 19,
7163684
Aug 19,
7351414
Dec 08,
7550434

2018
2019
2018
2019
2019
2018

DP

TERIPARATIDE RECOMBINANT HUMAN - FORTEO

N021318 002 6770623
Dec 08,
6977077
Aug 19,
Aug 19,
6977077
Dec 08,
7144861
Aug 19,
7163684
Aug 19,
7163684
Aug 19,
7351414
Aug 19,
7351414
Dec 08,
7550434

2018
2019
2019
2018
2019
2019
2019
2019
2018

DP

I-602

Jul

22, 2012

I-602

Jul

22, 2012

DP

DP

U-790
U-865
U-982

U-982
U-994
U-982

DP

DP

U-983
U-994
U-984
U-994
U-982

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 191 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

TESAMORELIN ACETATE - EGRIFTA

May
N022505 001 5861379

May
6020311

Jul
7144577

Aug
7316997

26,
26,
14,
14,

2015
2015
2020
2023

PATENT
CODES
DS
DS

DP
DP

PATENT
DELIST
REQUESTED

U-1100
U-1100

U-1100

U-1100

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Nov

10, 2015

TESTOSTERONE - ANDRODERM
N020489 003

NS

Oct

20, 2014

TESTOSTERONE - ANDRODERM
N020489 004

NS

Oct

20, 2014

TESTOSTERONE - ANDROGEL

N021015 001 6503894

6503894*PED

Aug
Mar

30, 2020
01, 2021

U-490

TESTOSTERONE - ANDROGEL

N021015 002 6503894

6503894*PED

Aug
Mar

30, 2020
01, 2021

U-490

TESTOSTERONE - ANDROGEL

N021015 003 6503894

6503894*PED

Aug
Mar

30, 2020
01, 2021

U-490

TESTOSTERONE - ANDROGEL

N022309 001 6503894

Aug

30, 2020

U-1103

NP

Apr

29, 2014

TESTOSTERONE - AXIRON

N022504 001 6299900

6818226

6923983

8071075

Feb
Feb
Feb
Feb

19,
19,
19,
19,

2017
2017
2017
2017

DP
DP
DP
DP

U-1103
U-1103

U-1103

U-1103

NP

Nov

23, 2013

TESTOSTERONE - FORTESTA

N021463 001 6319913

6579865

Nov
Nov

09, 2018
09, 2018

U-490

NP

Dec

29, 2013

DP

TESTOSTERONE - STRIANT

N021543 001 6248358

Aug

23, 2019

U-527

TESTOSTERONE - TESTIM

N021454 001 7320968

7608605

7608606

7608607

7608608

7608609

7608610

7935690

8063029

Jan
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

18,
21,
21,
21,
21,
21,
21,
21,
21,

U-843

U-1009
U-1009
U-1009
U-1009
U-1009
U-1009
U-1009
U-843

TESTOSTERONE - TESTODERM

N019762 001 5840327

Aug

15, 2016

TESTOSTERONE - TESTODERM

N019762 002 5840327

Aug

15, 2016

TESTOSTERONE - TESTODERM TTS

N020791 001 6348210

Nov

10, 2019

NCE
ODE

Aug
Aug

15, 2013
15, 2015

NCE
ODE

Aug
Aug

15, 2013
15, 2015

TETRABENAZINE - XENAZINE
N021894 001
TETRABENAZINE - XENAZINE
N021894 002

2025
2023
2023
2023
2023
2023
2023
2023
2023

U-440

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 192 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

THALIDOMIDE - THALOMID
N020785 001 5629327
6045501
6045501
6235756
6315720
6315720
6561976
6561976
6561977
6561977
6755784
6755784
6869399
6869399
6869399
6869399
6908432
6908432
7141018
7141018
7141018
7141018
7230012
7435745
7723361
7874984
7874984
7874984
7874984
7874984
7959566

May
Aug
Aug
Mar
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Dec
Nov
Mar
Aug
Aug
Aug
Aug
Aug
Oct

13,
28,
28,
01,
23,
23,
28,
28,
23,
23,
23,
23,
23,
23,
23,
23,
28,
28,
23,
23,
23,
23,
09,
03,
01,
28,
28,
28,
28,
28,
23,

2014
2018
2018
2013
2020
2020
2018
2018
2020
2020
2020
2020
2020
2020
2020
2020
2018
2018
2020
2020
2020
2020
2023
2017
2013
2018
2018
2018
2018
2018
2020

THALIDOMIDE - THALOMID
N020785 002 5629327
6045501
6045501
6235756
6315720
6315720
6561976
6561976
6561977
6561977
6755784
6755784
6869399
6869399
6869399
6869399
6908432
6908432
7141018
7141018
7141018
7141018
7230012
7435745
7723361
7874984
7874984
7874984
7874984
7874984
7959566

May
Aug
Aug
Mar
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Dec
Nov
Mar
Aug
Aug
Aug
Aug
Aug
Oct

13,
28,
28,
01,
23,
23,
28,
28,
23,
23,
23,
23,
23,
23,
23,
23,
28,
28,
23,
23,
23,
23,
09,
03,
01,
28,
28,
28,
28,
28,
23,

2014
2018
2018
2013
2020
2020
2018
2018
2020
2020
2020
2020
2020
2020
2020
2020
2018
2018
2020
2020
2020
2020
2023
2017
2013
2018
2018
2018
2018
2018
2020

PATENT
CODES
U-731
U-731
U-371
U-731
U-731
U-442
U-731
U-371
U-371
U-731
U-371
U-731
U-371
U-731
U-732
U-733
U-731
U-371
U-731
U-371
U-733
U-732

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ODE

May

25, 2013

ODE

May

25, 2013

DP
U-899
U-1058
U-1109
U-442
U-371
U-732
U-733
U-1155

U-731
U-371
U-731
U-731
U-731
U-442
U-731
U-371
U-371
U-731
U-731
U-371
U-732
U-731
U-371
U-733
U-371
U-731
U-732
U-733
U-731
U-371
DP
U-899
U-1058
U-371
U-1109
U-732
U-733
U-442
U-1155

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 193 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

THALIDOMIDE - THALOMID
N020785 003 5629327
6045501
6045501
6235756
6315720
6315720
6561976
6561976
6561977
6561977
6755784
6755784
6869399
6869399
6869399
6869399
6908432
6908432
7141018
7141018
7141018
7141018
7230012
7435745
7723361
7874984
7874984
7874984
7874984
7874984
7959566

May
Aug
Aug
Mar
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Aug
Aug
Oct
Oct
Oct
Oct
Dec
Nov
Mar
Aug
Aug
Aug
Aug
Aug
Oct

13,
28,
28,
01,
23,
23,
28,
28,
23,
23,
23,
23,
23,
23,
23,
23,
28,
28,
23,
23,
23,
23,
09,
03,
01,
28,
28,
28,
28,
28,
23,

2014
2018
2018
2013
2020
2020
2018
2018
2020
2020
2020
2020
2020
2020
2020
2020
2018
2018
2020
2020
2020
2020
2023
2017
2013
2018
2018
2018
2018
2018
2020

THALIDOMIDE - THALOMID
N020785 004 5629327
6045501
6235756
6315720
6561976
6561977
6755784
6869399
6908432
7141018
7435745
7723361
7874984
7874984
7874984
7874984
7874984
7959566

May
Aug
Mar
Oct
Aug
Oct
Oct
Oct
Aug
Oct
Nov
Mar
Aug
Aug
Aug
Aug
Aug
Oct

13,
28,
01,
23,
28,
23,
23,
23,
28,
23,
03,
01,
28,
28,
28,
28,
28,
23,

2014
2018
2013
2020
2018
2020
2020
2020
2018
2020
2017
2013
2018
2018
2018
2018
2018
2020

THYROTROPIN ALFA - THYROGEN

N020898 001 5840566
6365127

Nov
Nov

24, 2015
24, 2015

TIAGABINE HYDROCHLORIDE - GABITRIL

N020646 001 5010090
Sep
5354760
Mar
5866590
Apr
5958951
Jun

30,
24,
29,
10,

2011
2012
2016
2017

TIAGABINE HYDROCHLORIDE - GABITRIL

N020646 002 5010090
Sep
5354760
Mar
5866590
Apr
5958951
Jun

30,
24,
29,
10,

2011
2012
2016
2017

PATENT
CODES
U-731
U-731
U-371
U-731
U-731
U-442
U-371
U-731
U-731
U-371
U-371
U-731
U-731
U-732
U-733
U-371
U-371
U-731
U-731
U-732
U-371
U-733

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ODE

May

25, 2013

ODE

May

23, 2013

ODE

Dec

14, 2014

DP
U-899
U-1058
U-371
U-442
U-733
U-732
U-1109
U-1155

U-731
U-731
U-731
U-731
U-731
U-731
U-731
U-731
U-731
U-731
U-899
U-1058
U-371
U-1109
U-442
U-732
U-733
U-1155

DS

DP

U-556

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 194 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

TIAGABINE HYDROCHLORIDE - GABITRIL

N020646 003 5010090
Sep
5354760
Mar
5866590
Apr
5958951
Jun

30,
24,
29,
10,

2011
2012
2016
2017

TIAGABINE HYDROCHLORIDE - GABITRIL

N020646 004 5010090
Sep
5354760
Mar
5866590
Apr
5958951
Jun

30,
24,
29,
10,

2011
2012
2016
2017

TIAGABINE HYDROCHLORIDE - GABITRIL

Sep
N020646 005 5010090
Mar
5354760
Apr
5866590
Jun
5958951

30,
24,
29,
10,

2011
2012
2016
2017

TICAGRELOR - BRILINTA
N022433 001 6251910
6525060
7250419
7265124

Jul
Dec
Dec
Jul

15,
02,
02,
09,

2018
2019
2019
2021

TIGECYCLINE - TYGACIL
N021821 001 7879828
RE40086
RE40183

Feb
Jun
Apr

05, 2029
25, 2013
09, 2016

TIMOLOL MALEATE - ISTALOL

N021516 001 6335335

Nov

02, 2018

DP

TIMOLOL MALEATE - TIMOLOL MALEATE

N020963 001 6174524
Mar
6174524*PED
Sep

26, 2019
26, 2019

DP

TIMOLOL MALEATE - TIMOLOL MALEATE

N020963 002 6174524
Mar
6174524*PED
Sep

26, 2019
26, 2019

DP

DS
DS
DS
DS

DP
DP
DP

U-282

TIOTROPIUM BROMIDE MONOHYDRATE

N021395 001 5478578
6777423
6908928
6908928
7070800
7309707
7642268
7694676
8022082
RE38912
RE39820

- SPIRIVA
Dec 26, 2012
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

TIPRANAVIR - APTIVUS
N021814 001 5852195
5852195*PED
6147095
6147095*PED
6169181
6169181*PED
6231887
6231887*PED

Jun
Dec
Oct
Apr
May
Nov
Jul
Jan

22,
22,
29,
29,
06,
06,
27,
27,

2019
2019
2019
2020
2014
2014
2018
2019

DS

TIPRANAVIR - APTIVUS
N022292 001 5852195
5852195*PED
6147095
6147095*PED
6169181
6169181*PED

Jun
Dec
Oct
Apr
May
Nov

22,
22,
29,
29,
06,
06,

2019
2019
2019
2020
2014
2014

DS

DS
DS
DS
DS
DS

DS

DP

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NCE

Jul

20, 2016

I-588
I-587
I-586

Mar
Mar
Mar

20, 2012
20, 2012
20, 2012

M-89

Dec

17, 2012

PED

Dec

23, 2011

PED

Dec

23, 2011

U-1171
U-1171
U-1171

DP
DS

PATENT
DELIST
REQUESTED

U-762
U-566
U-566

U-1186
U-566

U-670
DS
DP

U-670
DS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 195 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

TIROFIBAN HYDROCHLORIDE - AGGRASTAT

N020912 001 5292756
May 14, 2012
5733919
Oct 23, 2016
5965581
Oct 23, 2016
5972967
Oct 23, 2016
5978698
Oct 08, 2017
6136794
Jan 29, 2019

PATENT
DELIST
REQUESTED

U-230

TIROFIBAN HYDROCHLORIDE - AGGRASTAT

N020913 001 5292756
May 14, 2012
5733919
Oct 23, 2016
5965581
Oct 23, 2016
5972967
Oct 23, 2016
5978698
Oct 08, 2017
6136794
Jan 29, 2019

U-230

TIROFIBAN HYDROCHLORIDE - AGGRASTAT

N020913 002 5292756
May 14, 2012
5733919
Oct 23, 2016
5965581
Oct 23, 2016
5972967
Oct 23, 2016
5978698
Oct 08, 2017
6136794
Jan 29, 2019

U-230

TIROFIBAN HYDROCHLORIDE - AGGRASTAT

N020913 003 5292756
May 14, 2012
5733919
Oct 23, 2016
5965581
Oct 23, 2016
5972967
Oct 23, 2016
5978698
Oct 08, 2017
6136794
Jan 29, 2019

U-230

TIZANIDINE HYDROCHLORIDE - ZANAFLEX

N021447 001 6455557
Nov 28, 2021
TIZANIDINE HYDROCHLORIDE - ZANAFLEX
N021447 002 6455557
Nov 28, 2021
TIZANIDINE HYDROCHLORIDE - ZANAFLEX
N021447 003 6455557
Nov 28, 2021
TOBRAMYCIN - TOBI
N050753 001 5508269

Oct

19, 2014

TOLCAPONE - TASMAR
N020697 001 5236952
5476875

Jan
Dec

29, 2012
19, 2012

U-219

TOLCAPONE - TASMAR
N020697 002 5236952
5476875

Jan
Dec

29, 2012
19, 2012

U-219

TOLTERODINE TARTRATE - DETROL

N020771 001 5382600
5382600*PED
5559269
5559269*PED

Mar
Sep
Nov
May

25,
25,
05,
05,

2012
2012
2013
2014

TOLTERODINE TARTRATE - DETROL

N020771 002 5382600
5382600*PED
5559269
5559269*PED

Mar
Sep
Nov
May

25,
25,
05,
05,

2012
2012
2013
2014

DP

U-909

U-318

U-318

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 196 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

TOLTERODINE TARTRATE - DETROL LA

Mar
N021228 001 5382600
Sep
5382600*PED
Nov
6630162
May
6630162*PED
Aug
6770295
Feb
6770295*PED
Aug
6911217
Feb
6911217*PED

25,
25,
11,
11,
26,
26,
26,
26,

2012
2012
2019
2020
2019
2020
2019
2020

TOLTERODINE TARTRATE - DETROL LA

Mar
N021228 002 5382600
Sep
5382600*PED
Nov
6630162
May
6630162*PED
Aug
6770295
Feb
6770295*PED
Aug
6911217
Feb
6911217*PED

25,
25,
11,
11,
26,
26,
26,
26,

2012
2012
2019
2020
2019
2020
2019
2020

TOLVAPTAN - SAMSCA
N022275 001 5753677

May

19, 2015

U-978

NCE

May

19, 2014

TOLVAPTAN - SAMSCA
N022275 002 5753677

May

19, 2015

U-978

NCE

May

19, 2014

TOLVAPTAN - SAMSCA
N022275 003 5753677

May

19, 2015

U-978

NCE

May

19, 2014

TOPIRAMATE - TOPAMAX
N020505 001 5998380
5998380*PED
6503884
6503884*PED
7018983
7018983*PED
7498311
7498311*PED

Oct
Apr
Oct
Apr
Oct
Apr
Oct
Apr

13,
13,
13,
13,
13,
13,
13,
13,

2015
2016
2015
2016
2015
2016
2015
2016

U-598

M-54
PED

Dec
Jun

22, 2012
22, 2013

TOPIRAMATE - TOPAMAX
N020505 002 5998380
5998380*PED
6503884
6503884*PED
7018983
7018983*PED
7498311
7498311*PED

Oct
Apr
Oct
Apr
Oct
Apr
Oct
Apr

13,
13,
13,
13,
13,
13,
13,
13,

2015
2016
2015
2016
2015
2016
2015
2016

U-598

M-54
PED

Dec
Jun

22, 2012
22, 2013

TOPIRAMATE - TOPAMAX
N020505 003 5998380
5998380*PED
6503884
6503884*PED
7018983
7018983*PED
7498311
7498311*PED

Oct
Apr
Oct
Apr
Oct
Apr
Oct
Apr

13,
13,
13,
13,
13,
13,
13,
13,

2015
2016
2015
2016
2015
2016
2015
2016

U-598

M-54
PED

Dec
Jun

22, 2012
22, 2013

TOPIRAMATE - TOPAMAX
N020505 004 5998380
5998380*PED
6503884
6503884*PED
7018983
7018983*PED
7498311
7498311*PED

Oct
Apr
Oct
Apr
Oct
Apr
Oct
Apr

13,
13,
13,
13,
13,
13,
13,
13,

2015
2016
2015
2016
2015
2016
2015
2016

U-598

M-54
PED

Dec
Jun

22, 2012
22, 2013

DP

U-544

DP

U-544

DP
DP

U-544
U-544

DP

U-544

DP

U-544

DP
DP

U-544
U-544

U-598
U-723
U-955

U-598
U-723
U-955

U-598
U-723
U-955

U-598
U-723
U-955

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 197 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

TOPIRAMATE - TOPAMAX
N020505 005 5998380
5998380*PED
6503884
6503884*PED
7018983
7018983*PED
7498311
7498311*PED

Oct
Apr
Oct
Apr
Oct
Apr
Oct
Apr

13,
13,
13,
13,
13,
13,
13,
13,

2015
2016
2015
2016
2015
2016
2015
2016

U-598

TOPIRAMATE - TOPAMAX
N020505 006 5998380
5998380*PED
6503884
6503884*PED
7018983
7018983*PED
7498311
7498311*PED

Oct
Apr
Oct
Apr
Oct
Apr
Oct
Apr

13,
13,
13,
13,
13,
13,
13,
13,

2015
2016
2015
2016
2015
2016
2015
2016

U-598

TOPIRAMATE - TOPAMAX
N020844 001 5998380
5998380*PED
6503884
6503884*PED
7018983
7018983*PED
7125560
7125560*PED
7498311
7498311*PED

Oct
Apr
Oct
Apr
Oct
Apr
Mar
Sep
Oct
Apr

13,
13,
13,
13,
13,
13,
01,
01,
13,
13,

2015
2016
2015
2016
2015
2016
2019
2019
2015
2016

U-598

TOPIRAMATE - TOPAMAX
N020844 002 5998380
5998380*PED
6503884
6503884*PED
7018983
7018983*PED
7125560
7125560*PED
7498311
7498311*PED

Oct
Apr
Oct
Apr
Oct
Apr
Mar
Sep
Oct
Apr

13,
13,
13,
13,
13,
13,
01,
01,
13,
13,

2015
2016
2015
2016
2015
2016
2019
2019
2015
2016

U-598

TOPIRAMATE - TOPAMAX SPRINKLE

N020844 003 5998380
5998380*PED
6503884
6503884*PED
7018983
7018983*PED
7125560
7125560*PED
7498311
7498311*PED

Oct
Apr
Oct
Apr
Oct
Apr
Mar
Sep
Oct
Apr

13,
13,
13,
13,
13,
13,
01,
01,
13,
13,

2015
2016
2015
2016
2015
2016
2019
2019
2015
2016

U-598

TOPOTECAN HYDROCHLORIDE - HYCAMTIN

Oct
N020671 001 5674872
Apr
5674872*PED

07, 2014
07, 2015

U-910

TRAMADOL HYDROCHLORIDE - CONZIP

N022370 001 7858118
Apr

11, 2022

DP

U-1104

TRAMADOL HYDROCHLORIDE - CONZIP

N022370 002 7858118
Apr

11, 2022

DP

U-1104

TRAMADOL HYDROCHLORIDE - CONZIP

Apr
N022370 003 7858118

11, 2022

DP

U-1104

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

M-54
PED

Dec
Jun

22, 2012
22, 2013

M-54
PED

Dec
Jun

22, 2012
22, 2013

M-54
PED

Dec
Jun

22, 2012
22, 2013

M-54
PED

Dec
Jun

22, 2012
22, 2013

M-54
PED

Dec
Jun

22, 2012
22, 2013

U-598
U-723
U-955

U-598
U-723
U-955

U-598
U-723
U-766
U-955

U-598
U-723
U-766
U-955

U-598
U-723
U-766
U-955

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 198 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

TRAMADOL HYDROCHLORIDE - RYZOLT

May
N021745 001 5591452
May
6254887
Jun
6607748
Oct
7988998

10,
10,
29,
27,

2014
2014
2020
2023

DP
DP
DP
DP

NP

Dec

30, 2011

TRAMADOL HYDROCHLORIDE - RYZOLT

May
N021745 002 5591452
May
6254887
Jun
6607748
Oct
7988998

10,
10,
29,
27,

2014
2014
2020
2023

DP
DP
DP
DP

NP

Dec

30, 2011

TRAMADOL HYDROCHLORIDE - RYZOLT

May
N021745 003 5591452
May
6254887
Jun
6607748
Oct
7988998

10,
10,
29,
27,

2014
2014
2020
2023

DP
DP
DP
DP

NP

Dec

30, 2011

NDF

Nov

13, 2012

NDF

Feb

02, 2013

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE

N021693 001 5464632
Mar 22, 2013
6106861
Dec 05, 2017

DP
DP

TRAMADOL HYDROCHLORIDE - ULTRAM

Oct
N020281 001 6339105
Apr
6339105*PED

12, 2019
12, 2020

U-435
U-435

TRAMADOL HYDROCHLORIDE - ULTRAM

Oct
N020281 002 6339105
Apr
6339105*PED

12, 2019
12, 2020

U-435
U-435

TRANDOLAPRIL - MAVIK
N020528 001 5744496

Apr

28, 2015

U-229

TRANDOLAPRIL - MAVIK
N020528 002 5744496

Apr

28, 2015

U-229

TRANDOLAPRIL - MAVIK
N020528 003 5744496

Apr

28, 2015

U-229

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA

N020591 001 5721244
Feb 24, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N020591 002 5721244
Feb 24, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N020591 003 5721244
Feb 24, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N020591 004 5721244
Feb 24, 2015
TRANEXAMIC ACID - LYSTEDA
N022430 001 7947739
8022106

Mar
Mar

04, 2025
04, 2025

DP

TRAVOPROST - TRAVATAN
N021257 001 5510383
5631287
5849792
5889052
6011062

Aug
Dec
Dec
Dec
Dec

03,
22,
22,
02,
22,

2013
2014
2014
2014
2014

DP

TRAVOPROST - TRAVATAN Z
N021994 001 5510383
5889052
6503497
6849253

Aug
Dec
May
May

03,
02,
06,
06,

2013
2014
2012
2012

DP
DP
DP
DP

29, 2020
27, 2027

DP
DP

TRAZODONE HYDROCHLORIDE - OLEPTRO

N022411 001 6607748
Jun
7829120
Mar

U-1182

DP
DP
DP

U-383
U-382
U-383
U-383

U-383
U-383

U-796

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 199 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

TRAZODONE HYDROCHLORIDE - OLEPTRO

N022411 002 6607748
Jun
7829120
Mar

29, 2020
27, 2027

TREPROSTINIL SODIUM - REMODULIN

N021272 001 5153222
Oct
6765117
Oct
7999007
Mar

06, 2014
24, 2017
29, 2029

DS

TREPROSTINIL SODIUM - REMODULIN

N021272 002 5153222
Oct
6765117
Oct
7999007
Mar

06, 2014
24, 2017
29, 2029

DS

TREPROSTINIL SODIUM - REMODULIN

N021272 003 5153222
Oct
6765117
Oct
7999007
Mar

06, 2014
24, 2017
29, 2029

DS

TREPROSTINIL SODIUM - REMODULIN

N021272 004 5153222
Oct
6765117
Oct
7999007
Mar

06, 2014
24, 2017
29, 2029

DS

TREPROSTINIL SODIUM - TYVASO

N022387 001 5153222
6521212
6756033
6765117

Oct
Nov
Nov
Oct

16,
13,
13,
24,

TRETINOIN - ATRALIN
N022070 001 5670547

Sep

23, 2014

TRETINOIN - RENOVA
N021108 001 6531141

Mar

07, 2020

TRETINOIN - RETIN-A MICRO

N020475 001 5955109

Sep

21, 2016

TRETINOIN - RETIN-A MICRO

N020475 002 5955109

Sep

21, 2016

TRIAMCINOLONE ACETONIDE - NASACORT AQ

N020468 001 5976573
Jul 03,
5976573
Jul 03,
6143329
Jul 03,
7977045
Jul 03,

2014
2018
2018
2017

DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

NDF

Feb

02, 2013

NDF
ODE

Jul
Jul

30, 2012
30, 2016

NPP

Sep

19, 2011

NP

Mar

10, 2013

U-796

U-455
DP

U-1174

U-455
DP

U-1174

U-455
DP

U-1174

U-455
DP

U-1174

U-1019
U-1018
U-1018
DS

DP

DP

U-134

U-134

2016
2016
2016
2016

DP
DP
DP
DP

U-295
U-896
U-896
U-896

TRIAMCINOLONE ACETONIDE - TRIESENCE

N022048 001 6395294
Jan 13, 2020

DP

U-846

TRIMETHOPRIM HYDROCHLORIDE - PRIMSOL

Aug 07, 2016
A074973 001 5763449
Aug 07, 2016
5962461
TRIMETREXATE GLUCURONATE - NEUTREXIN
May 18, 2018
N020326 001 6017922
TRIMETREXATE GLUCURONATE - NEUTREXIN
May 18, 2018
N020326 002 6017922
TRIPTORELIN PAMOATE - TRELSTAR
N020715 001 5776885
Jul

07, 2015

TRIPTORELIN PAMOATE - TRELSTAR

N021288 001 5776885
Jul

07, 2015

DP

TRIPTORELIN PAMOATE - TRELSTAR

N022437 001 5776885
Jul

07, 2015

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 200 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

TROGLITAZONE - PRELAY
N020719 001 5602133
5859037
6011049
6046202

Sep
Nov
Nov
Sep

15,
13,
13,
15,

2013
2017
2017
2013

U-173
U-251
U-301
U-317

TROGLITAZONE - PRELAY
N020719 002 5602133
5859037
6011049
6046202

Sep
Nov
Nov
Sep

15,
13,
13,
15,

2013
2017
2017
2013

U-173
U-251
U-301
U-317

TROGLITAZONE - PRELAY
N020719 003 5602133
5859037
6011049
6046202

Sep
Nov
Nov
Sep

15,
13,
13,
15,

2013
2017
2017
2013

U-173
U-251
U-301
U-317

TROGLITAZONE - REZULIN
N020720 001 5602133
5859037
6011049
6046202

Sep
Nov
Nov
Sep

15,
13,
13,
15,

2013
2017
2017
2013

U-173
U-251
U-301
U-317

TROGLITAZONE - REZULIN
N020720 002 5602133
5859037
6011049
6046202

Sep
Nov
Nov
Sep

15,
13,
13,
15,

2013
2017
2017
2013

U-173
U-251
U-301
U-317

TROGLITAZONE - REZULIN
N020720 003 5602133
5859037
6011049
6046202

Sep
Nov
Nov
Sep

15,
13,
13,
15,

2013
2017
2017
2013

U-173
U-251
U-301
U-317

TROSPIUM CHLORIDE - SANCTURA XR

N022103 001 7410978
Feb
7759359
Nov
7763635
Nov
7781448
Nov
7781449
Nov

01,
04,
04,
04,
04,

2025
2024
2024
2024
2024

TROVAFLOXACIN MESYLATE - TROVAN

N020759 001 5164402
Dec
5763454
Jun
6187341
Jan

18, 2011
15, 2015
20, 2019

U-282
U-282

TROVAFLOXACIN MESYLATE - TROVAN

N020759 002 5164402
Dec
5763454
Jun
6187341
Jan

18, 2011
15, 2015
20, 2019

U-282
U-282

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DP
U-1071
U-1071
U-1071
U-1071

TRYPAN BLUE - MEMBRANEBLUE

N022278 001

ODE

Dec

16, 2011

ULIPRISTAL ACETATE - ELLA

N022474 001

NCE

Aug

13, 2015

UNOPROSTONE ISOPROPYL - RESCULA

N021214 001 5221763
Jul
6458836
Jul

15, 2012
09, 2021

UROFOLLITROPIN - FERTINEX
N019415 004 5767067

Jun

16, 2015

UROFOLLITROPIN - FERTINEX
N019415 005 5767067

Jun

16, 2015

DS
U-333

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 201 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

VALACYCLOVIR HYDROCHLORIDE - VALTREX

N020487 001 5879706
Jan 19, 2016
5879706
Jan 19, 2016
5879706*PED
Jul 19, 2016
6107302
Jan 19, 2016
6107302
Jan 19, 2016
6107302*PED
Jul 19, 2016
VALACYCLOVIR HYDROCHLORIDE - VALTREX
N020487 002 5879706
Jan 19, 2016
5879706
Jan 19, 2016
5879706*PED
Jul 19, 2016
6107302
Jan 19, 2016
6107302
Jan 19, 2016
6107302*PED
Jul 19, 2016

PATENT
CODES
DP
DP
DS
DS

U-530
U-894
U-894
U-530

DP
DP
DS
DS

U-894
U-530
U-530
U-894

VALDECOXIB - BEXTRA
N021341 002 5633272

Feb

13, 2015

U-462

VALDECOXIB - BEXTRA
N021341 003 5633272

Feb

13, 2015

U-462

VALGANCICLOVIR HYDROCHLORIDE - VALCYTE

Mar 29, 2015
N021304 001 6083953
Mar 29, 2015
6083953
Sep 29, 2015
6083953*PED
VALGANCICLOVIR HYDROCHLORIDE - VALCYTE
N022257 001 6083953
Mar 29, 2015
6083953
Mar 29, 2015

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-570
NPP
PED
PED

Sep
Sep
Mar
Mar

02,
02,
02,
02,

2011
2011
2012
2012

I-570
NPP
PED
PED

Sep
Sep
Mar
Mar

02,
02,
02,
02,

2011
2011
2012
2012

DS
DS

DP
DP

U-384
U-854

D-125
I-604
PED

Aug
Aug
Feb

05, 2013
28, 2012
28, 2013

DS
DS

DP
DP

U-384
U-854

D-125
NDF
PED

Aug
Aug
Feb

05, 2013
28, 2012
28, 2013

VALSARTAN - DIOVAN
N020665 001 5399578
5399578*PED

Mar
Sep

21, 2012
21, 2012

U-3

VALSARTAN - DIOVAN
N020665 002 5399578
5399578*PED

Mar
Sep

21, 2012
21, 2012

U-3

VALSARTAN - DIOVAN
N021283 001 5399578
5399578*PED
5972990
5972990*PED
6294197
6294197*PED

Mar
Sep
Oct
Apr
Jun
Dec

21,
21,
26,
26,
18,
18,

2012
2012
2016
2017
2017
2017

VALSARTAN - DIOVAN
N021283 002 5399578
5399578*PED
5972990
5972990*PED
6294197
6294197*PED

Mar
Sep
Oct
Apr
Jun
Dec

21,
21,
26,
26,
18,
18,

2012
2012
2016
2017
2017
2017

VALSARTAN - DIOVAN
N021283 003 5399578
5399578*PED
5972990
5972990*PED
6294197
6294197*PED

Mar
Sep
Oct
Apr
Jun
Dec

21,
21,
26,
26,
18,
18,

2012
2012
2016
2017
2017
2017

U-692
U-3

U-692
U-3

U-692
U-3

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 202 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

VALSARTAN - DIOVAN
N021283 004 5399578
5399578*PED
5972990
5972990*PED
6294197
6294197*PED

Mar
Sep
Oct
Apr
Jun
Dec

21,
21,
26,
26,
18,
18,

VANDETANIB - VANDETANIB
N022405 001 7173038
8067427
RE42353

Aug
Aug
Sep

14, 2021
08, 2028
23, 2017

DS

VANDETANIB - VANDETANIB
N022405 002 7173038
8067427
RE42353

Aug
Aug
Sep

14, 2021
08, 2028
23, 2017

DS

VARDENAFIL HYDROCHLORIDE - LEVITRA

N021400 001 6362178
Oct
7696206
Oct

2012
2012
2016
2017
2017
2017

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-692
U-3

DP
DP
DP

NCE
ODE

Apr
Apr

06, 2016
06, 2018

NCE
ODE

Apr
Apr

06, 2016
06, 2018

DS

DP
DP
DP

31, 2018
31, 2018

DS
DS

DP
DP

U-533
U-533

VARDENAFIL HYDROCHLORIDE - LEVITRA

N021400 002 6362178
Oct
7696206
Oct

31, 2018
31, 2018

DS
DS

DP
DP

U-533
U-533

VARDENAFIL HYDROCHLORIDE - LEVITRA

N021400 003 6362178
Oct
7696206
Oct

31, 2018
31, 2018

DS
DS

DP
DP

U-533
U-533

VARDENAFIL HYDROCHLORIDE - LEVITRA

N021400 004 6362178
Oct
7696206
Oct

31, 2018
31, 2018

DS
DS

DP
DP

U-533
U-533

VARDENAFIL HYDROCHLORIDE - STAXYN

N200179 001 6362178
Oct
7696206
Oct

31, 2018
31, 2018

U-155
U-155

NDF

Jun

17, 2013

VARENICLINE TARTRATE - CHANTIX

May
N021928 001 6410550
May
6890927
Aug
7265119

10, 2020
06, 2022
03, 2022

DS
DS
DS

DP
DP
DP

U-56
U-56
U-56

M-105

Jul

22, 2014

VARENICLINE TARTRATE - CHANTIX

N021928 002 6410550
May
6890927
May
Aug
7265119

10, 2020
06, 2022
03, 2022

DS
DS
DS

DP
DP
DP

U-56
U-56
U-56

M-105

Jul

22, 2014

VELAGLUCERASE ALFA - VPRIV

N022575 001

NCE

Feb

26, 2015

VELAGLUCERASE ALFA - VPRIV

N022575 002

NCE

Feb

26, 2015

NCE
ODE

Aug
Aug

17, 2016
17, 2018

VEMURAFENIB - ZELBORAF
N202429 001 7504509
7863288

Oct
Jun

22, 2026
20, 2029

DS

DS
DS

DP
DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 203 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR

N020699 001 5916923
Jun 28, 2013
5916923*PED
Dec 28, 2013
6274171
Mar 20, 2017
6274171*PED
Sep 20, 2017
6310101
Jun 28, 2013
6403120
Mar 20, 2017
6403120
Mar 20, 2017
6403120*PED
Sep 20, 2017
6403120*PED
Sep 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017
6419958*PED
Sep 20, 2017
6419958*PED
Sep 20, 2017
6444708
Jun 28, 2013
6444708*PED
Dec 28, 2013
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N020699 002 5916923
Jun 28, 2013
5916923*PED
Dec 28, 2013
6274171
Mar 20, 2017
6274171*PED
Sep 20, 2017
6310101
Jun 28, 2013
6403120
Mar 20, 2017
6403120
Mar 20, 2017
6403120*PED
Sep 20, 2017
6403120*PED
Sep 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017
6419958*PED
Sep 20, 2017
6419958*PED
Sep 20, 2017
6444708
Jun 28, 2013
6444708*PED
Dec 28, 2013
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N020699 003 5916923
Jun 28, 2013
5916923*PED
Dec 28, 2013
6274171
Mar 20, 2017
6274171*PED
Sep 20, 2017
6403120
Mar 20, 2017
6403120
Mar 20, 2017
6403120*PED
Sep 20, 2017
6403120*PED
Sep 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017
6419958*PED
Sep 20, 2017
6419958*PED
Sep 20, 2017
6444708
Jun 28, 2013
6444708*PED
Dec 28, 2013
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N020699 004 5916923
Jun 28, 2013
5916923*PED
Dec 28, 2013
6274171
Mar 20, 2017
6274171*PED
Sep 20, 2017
6310101
Jun 28, 2013
6403120
Mar 20, 2017
6403120
Mar 20, 2017
6403120*PED
Sep 20, 2017
6403120*PED
Sep 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017
6419958*PED
Sep 20, 2017
6419958*PED
Sep 20, 2017
6444708
Jun 28, 2013
6444708*PED
Dec 28, 2013

PATENT
CODES
U-398
U-398

U-46
U-451
U-535
U-535
U-451
U-459
U-535
U-535
U-459
U-398
U-398

U-398
U-398

U-46
U-451
U-535
U-451
U-535
U-535
U-459
U-535
U-459
U-398
U-398

U-398
U-398

U-535
U-451
U-535
U-451
U-535
U-459
U-459
U-535
U-398
U-398

U-398
U-398

U-46
U-535
U-451
U-535
U-451
U-535
U-459
U-535
U-459
U-398
U-398

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 204 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE

N022104 001 6403120
Mar 20, 2017
6403120
Mar 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017

U-839
U-535
U-839
U-535

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE

N022104 002 6403120
Mar 20, 2017
6403120
Mar 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017

U-839
U-535
U-839
U-535

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE

N022104 003 6403120
Mar 20, 2017
6403120
Mar 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017

U-839
U-535
U-535
U-839

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE

N022104 004 6403120
Mar 20, 2017
6403120
Mar 20, 2017
6419958
Mar 20, 2017
6419958
Mar 20, 2017

U-839
U-535
U-839
U-535

VERAPAMIL HYDROCHLORIDE - COVERA-HS

Apr 04, 2017
N020552 001 6096339

U-365

VERAPAMIL HYDROCHLORIDE - COVERA-HS

Apr 04, 2017
N020552 002 6096339

U-365

VERTEPORFIN - VISUDYNE
N021119 001 5095030
5707608
5756541
5770619
5798349
6074666

Sep
Aug
Mar
Jan
Aug
Feb

09,
02,
11,
06,
25,
05,

2011
2015
2016
2015
2015
2012

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS
U-357
U-357
U-357

VIGABATRIN - SABRIL
N020427 001
VIGABATRIN - SABRIL
N022006 001
VILAZODONE HYDROCHLORIDE - VIIBRYD
Sep
N022567 001 5532241
Jun
7834020

29, 2014
05, 2022

DS
DS

DP
DP

U-839

VILAZODONE HYDROCHLORIDE - VIIBRYD

Sep
N022567 002 5532241
Jun
7834020

29, 2014
05, 2022

DS
DS

DP
DP

U-839

VILAZODONE HYDROCHLORIDE - VIIBRYD

Sep
N022567 003 5532241
Jun
7834020

29, 2014
05, 2022

DS
DS

DP
DP

U-839

VORICONAZOLE - VFEND
N021266 001 5364938
5567817

Nov
May

15, 2011
24, 2016

DS
DS

DP

U-540

VORICONAZOLE - VFEND
N021266 002 5364938
5567817

Nov
May

15, 2011
24, 2016

DS
DS

DP

U-540

VORICONAZOLE - VFEND
N021267 001 5364938
5567817
6632803

Nov
May
Jun

15, 2011
24, 2016
02, 2018

DS
DS

DP
DP

U-540

NCE

Aug

21, 2014

NCE
ODE

Aug
Aug

21, 2014
21, 2016

NCE

Jan

21, 2016

NCE

Jan

21, 2016

NCE

Jan

21, 2016

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 205 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

VORICONAZOLE - VFEND
N021630 001 5364938
5567817

Nov
May

15, 2011
24, 2016

VORINOSTAT - ZOLINZA
N021991 001 6087367
7399787
7456219
7652069
7732490
7851509
8067472
RE38506

Oct
Feb
Nov
Mar
Mar
Feb
Mar
Nov

04,
09,
14,
04,
04,
21,
04,
29,

2011
2025
2026
2023
2023
2024
2023
2012

ZAFIRLUKAST - ACCOLATE
N020547 001 5294636
5319097
5482963
5612367
6143775

Dec
Dec
Jan
Mar
Dec

11,
11,
09,
18,
11,

2011
2011
2013
2014
2011

ZAFIRLUKAST - ACCOLATE
N020547 003 5294636
5319097
5482963
5612367
6143775

Dec
Dec
Jan
Mar
Dec

11,
11,
09,
18,
11,

2011
2011
2013
2014
2011

ZANAMIVIR - RELENZA
N021036 001 5360817
5648379
5648379
5648379
6294572

Jul
Jul
Jul
Jul
Dec

26,
15,
15,
15,
15,

2013
2014
2014
2014
2014

ZICONOTIDE - PRIALT
N021060 003 5364842
5364842
5795864
5859186
5859186

Dec
Dec
Jun
Dec
Dec

30,
30,
27,
30,
30,

2016
2016
2015
2011
2011

ZICONOTIDE ACETATE - PRIALT

N021060 001 5364842
5364842
5795864
5859186
5859186

Dec
Dec
Jun
Dec
Dec

30,
30,
27,
30,
30,

2016
2016
2015
2011
2011

ZICONOTIDE ACETATE - PRIALT

N021060 002 5364842
5364842
5795864
5859186
5859186

Dec
Dec
Jun
Dec
Dec

30,
30,
27,
30,
30,

2016
2016
2015
2011
2011

ZICONOTIDE ACETATE - PRIALT

N021060 004 5364842
5364842
5795864
5859186
5859186

Dec
Dec
Jun
Dec
Dec

30,
30,
27,
30,
30,

2016
2016
2015
2011
2011

DP

ZILEUTON - ZYFLO CR
N022052 001 5422123
6183778

Jun
Sep

06, 2012
21, 2013

DP
DP

DS
DS

DP

DS
DP

DS

U-892
U-892
U-892

DP

U-189

U-189

DS

DP
U-721
U-722
U-274

DS

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-540

U-776
U-892

DP

PATENT
DELIST
REQUESTED

DP

U-48
U-55
DP
U-55
U-48

U-48
U-55
DP
U-55
U-48

U-48
U-55
DP
U-48
U-55

U-55
U-48
U-55
U-48

NCE
ODE

Oct
Oct

06, 2011
06, 2013

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 206 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ZIPRASIDONE HYDROCHLORIDE - GEODON

N020825 001 4831031
Mar
5312925
Sep
May
6150366
Dec
6245766

02,
01,
27,
18,

2012
2012
2019
2018

DS
DS

ZIPRASIDONE HYDROCHLORIDE - GEODON

N020825 002 4831031
Mar
5312925
Sep
May
6150366
Dec
6245766

02,
01,
27,
18,

2012
2012
2019
2018

DS
DS

ZIPRASIDONE HYDROCHLORIDE - GEODON

N020825 003 4831031
Mar
5312925
Sep
May
6150366
Dec
6245766

02,
01,
27,
18,

2012
2012
2019
2018

DS
DS

ZIPRASIDONE HYDROCHLORIDE - GEODON

N020825 004 4831031
Mar
5312925
Sep
May
6150366
Dec
6245766

02,
01,
27,
18,

2012
2012
2019
2018

DS
DS

ZIPRASIDONE HYDROCHLORIDE - GEODON

Mar
N021483 001 4831031
Sep
5312925
May
6150366
Dec
6245766
May
7175855

02,
01,
27,
18,
18,

2012
2012
2019
2018
2020

DS
DS

ZIPRASIDONE MESYLATE - GEODON

N020919 001 4831031
6110918
6232304
6399777

Mar
Mar
Apr
Apr

02,
26,
01,
01,

2012
2017
2017
2017

DS

DP

U-720

ZOLEDRONIC ACID - RECLAST

N021817 001 4939130
4939130*PED
7932241
7932241*PED
8052987

Sep
Mar
Feb
Aug
Mar

02,
02,
05,
05,
19,

2012
2013
2028
2028
2024

DS

DP

U-662

ZOLEDRONIC ACID - ZOMETA

N021223 001 4939130
4939130*PED

Sep
Mar

02, 2012
02, 2013

DS

DP

U-53

ZOLEDRONIC ACID - ZOMETA

N021223 002 4939130
4939130*PED

Sep
Mar

02, 2012
02, 2013

DS

DP

U-53

ZOLEDRONIC ACID - ZOMETA

N021223 003 4939130
4939130*PED
7932241

Sep
Mar
Feb

02, 2012
02, 2013
05, 2028

DS

DP

U-53

ZOLMITRIPTAN - ZOMIG
N020768 001 5466699
5466699*PED
5863935
5863935*PED

Nov
May
Nov
May

14,
14,
14,
14,

2012
2013
2012
2013

ZOLMITRIPTAN - ZOMIG
N020768 002 5466699
5466699*PED
5863935
5863935*PED

Nov
May
Nov
May

14,
14,
14,
14,

2012
2013
2012
2013

DP
DP
DP

U-720

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

I-615

Nov

20, 2012

I-615

Nov

20, 2012

I-615

Nov

20, 2012

I-615

Nov

20, 2012

I-595
I-584
I-581

May
Mar
Dec

29, 2012
15, 2012
19, 2011

PED

Sep

20, 2011

U-601

DP
DP
DP

U-720

U-601

DP
DP
DP

U-720

U-601

DP
DP
DP

U-720

U-601

DP
DP
DP

U-720
U-720
U-719
U-601

DP

DP
U-1199

DP

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

ADA 207 of 207

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST

See report footnote for information regarding report content

APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ZOLMITRIPTAN - ZOMIG
N021450 004 5466699
5466699*PED
6750237
6750237*PED
7220767
7220767*PED

Nov
May
Nov
May
Nov
May

14,
14,
28,
28,
28,
28,

ZOLMITRIPTAN - ZOMIG-ZMT
N021231 001 5466699
5466699*PED

Nov
May

14, 2012
14, 2013

ZOLMITRIPTAN - ZOMIG-ZMT
N021231 002 5466699
5466699*PED

Nov
May

14, 2012
14, 2013

ZOLPIDEM TARTRATE - AMBIEN CR

N021774 001 6514531
6514531*PED

Dec
Jun

01, 2019
01, 2020

DP

ZOLPIDEM TARTRATE - AMBIEN CR

N021774 002 6514531
6514531*PED

Dec
Jun

01, 2019
01, 2020

DP

ZOLPIDEM TARTRATE - EDLUAR

N021997 001 6761910

Sep

24, 2019

DP

U-674

ZOLPIDEM TARTRATE - EDLUAR

N021997 002 6761910

2012
2013
2020
2021
2020
2021

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

U-436
DP
DP

Sep

24, 2019

DP

U-674

ZOLPIDEM TARTRATE - INTERMEZZO

Apr
N022328 001 7658945
Feb
7682628

15, 2027
16, 2025

DP

U-1194
U-1194

NP

Nov

23, 2014

ZOLPIDEM TARTRATE - INTERMEZZO

Apr
N022328 002 7658945
Feb
7682628

15, 2027
16, 2025

DP

U-1194
U-1194

NP

Nov

23, 2014

ZOLPIDEM TARTRATE - ZOLPIMIST

N022196 001 7632517

01, 2017

Oct

U-70

Footnote:
1. Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR
314.53(d)(5).
2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor.
They may not be flagged with respect to other claims which may apply.

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 1 of 51

PATENT & EXCLUSIVITY ABBREVIATIONS

D
I
M
NC
NCE
NDF
NE
NP
NP*
NPP
NR
NS
ODE
PC
PED
RTO
U
W

NEW DOSING SCHEDULE (SEE INDIVIDUAL REFERENCES)

NEW INDICATION (SEE INDIVIDUAL REFERENCES)
MISCELLANEOUS EXCLUSIVITY CODES (SEE INDIVIDUAL REFERENCES)
NEW COMBINATION
NEW CHEMICAL ENTITY
NEW DOSAGE FORM
NEW ESTER OR SALT OF AN ACTIVE INGREDIENT
NEW PRODUCT
NEW PRODUCT (MINT FLAVORED)
NEW PATIENT POPULATION
NEW ROUTE
NEW STRENGTH
ORPHAN DRUG EXCLUSIVITY
PATENT CHALLENGE
PEDIATRIC EXCLUSIVITY
RX TO OTC SWITCH OR OTC USE
PATENT USE CODE (SEE INDIVIDUAL REFERENCES)
EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE
SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY

EXCLUSIVITY DOSING SCHEDULE

D-1
D-2
D-3
D-4
D-5
D-6
D-7
D-8
D-9
D-10
D-11
D-12
D-13
D-14
D-15
D-16
D-17
D-18
D-19
D-20
D-21
D-22
D-23
D-24
D-25
D-26
D-27
D-28
D-29
D-30
D-31
D-32
D-33
D-34
D-35
D-36

ONCE A DAY APPLICATION

ONCE DAILY DOSING
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
INTRAVENOUS, EPIDURAL AND INTRATHECAL DOSING
NARCOTIC OVERDOSE IN ADULTS
NARCOTIC OVERDOSE IN CHILDREN
POSTOPERATIVE NARCOTIC DEPRESSION IN CHILDREN
BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE DUODENAL ULCER
INCREASED MAXIMUM DAILY DOSAGE RECOMMENDATION
BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
SINGLE DAILY DOSE OF 25MG/37.5MG
CONTINUOUS INTRAVENOUS INFUSION
400MG EVERY 12 HOURS FOR THREE DAYS FOR UNCOMPLICATED URINARY TRACT INFECTIONS
LOWER RECOMMENDED STARTING DOSE GUIDELINES
BOLUS DOSING GUIDELINES
SINGLE 32MG DOSE
ALTERNATIVE DOSAGE OF 300MG ONCE DAILY AFTER THE EVENING MEAL
REDUCTION IN INFUSION TIME FROM 24 TO 4 HOURS FOR THE 60MG DOSE
INCREASE MAXIMUM DOSE AND VARIATIONS IN THE DOSING REGIMEN
FOR OVARIAN CANCER THE RECOMMENDED REGIMEN IS 135MG/M2 OR 175MG/M2 INTRAVENOUSLY OVER
THREE HOURS EVERY THREE WEEKS
ADDITIONAL DOSAGE REGIMEN EQUAL TO HALF THE ORIGINAL DOSING REGIMEN
ONCE WEEKLY APPLICATION
BID DOSING IN PATIENTS 12 YEARS OF AGE AND OLDER FOR PREVENTION OF NAUSEA AND VOMITING
ASSOCIATED WITH MODERATE EMETOGENIC CANCER CHEMOTHERAPY
USE OF ISOVUE-370 IN EXCRETORY UROGRAPHY AT EQUIVALENT GRAMS OF IODINE TO THE CURRENTLY
APPROVED ISOVUE-250 AND ISOVUE-300
INCREASE OF CUMULATIVE DOSE TO 0.3MMOL/KG FOR MRI OF CNS IN ADULTS
5000 IU DOSE FOR PHOPHYLAXIX AGAINST DEEP VEIN THROMBOSIS
CHANGE IN RECOMMENDED TOTAL DAILY DOSE TO 80MG (40MG BID)
REMOVAL OF THE RESTRICTIONS LIMITING TREATMENT TO TWO CONSECUTIVE WEEKS AND TO SMALL
AREAS
ONCE DAILY DOSING FOR PLAQUE PSORIASIS
EVERY FOUR MONTHS DOSAGE REGIMEN
FOR A ONE WEEK DOSING OF INTERDIGITAL TINEA PEDIS
FOR A SINGLE 2MG DOSE AS AN ALTERNATIVE TO THE 1MG DOSE GIVEN TWICE DAILY

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 2 of 51

EXCLUSIVITY DOSING SCHEDULE

D-37
D-38
D-39

D-40
D-41
D-42
D-43
D-44

D-45
D-46
D-47
D-48
D-49
D-50
D-51
D-52
D-53
D-54
D-55
D-56
D-57
D-58
D-59
D-60
D-61
D-62
D-63
D-64
D-65
D-66
D-67
D-68
D-69
D-70
D-71
D-72
D-73
D-74
D-75
D-76
D-77
D-78
D-79

DOSING REGIMEN FOR ADMINISTRATION EITHER ONCE DAILY (QD) OR TWICE DAILY (BID)
CONTINUOUS INFUSION AS AN ALTERNATE METHOD OF ADMINISTRATION
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..."
ONCE-A-DAY DOSING REGIMEN
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
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
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
ONCE DAILY DOSING FOR MAINTENANCE ONLY
NEW DOSING REGIMEN OF 80MG DAILY
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
PEDIATRIC DOSING GUIDELINES
INFORMATION FOR USE OF CORVERT IN POST-CARDIAC SURGERY PATIENTS
OPTIONAL STARTING DOSE OF 40MG/DAY
ALTERNATE DOSING REGIMEN OF 1250MG TWICE DAILY
USE IN PEDIATRIC PATIENTS FROM 1 MONTH TO 16 YEARS OF AGE
USE OF ZYBAN FOR MAINTENANCE THERAPY. TREATMENT UP TO 6 MONTHS WAS SHOWN EFFICACIOUS
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
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
CHANGE IN DOSING INTERVAL TO ONCE-DAILY ADMINISTRATION
REDUCTION OF ELEVATED LDL-C IN A NEW, HIGHER STRENGTH TABLET, 0.8MG, AND FOR EXTENSION
OF THE DOSAGE RANGE TO 0.8MG DAILY
ADDITION OF A POST-OPERATIVE DOSING REGIMEN
ONCE WEEKLY DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
ONCE WEEKLY DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
TO ALLOW A TITRATION DOSING REGIMEN USING A 25MG DOSE
INCREASING DOSAGE FOR NERVE BLOCK ANESTHESIA USING NAROPIN 7.5MG/ML AND FOR EXTENDING
THE DURATION OF TREATMENT FOR POSTOPERATIVE ANALGESIA USING NAROPIN 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
DOSING RECOMMENDATIONS FOR PATIENTS UNDERGOING PCI
SHORTER TREATMENT COURSE OF THREE DAYS IN THE TREATMENT OF RECURRENT EPISODES OF GENITAL
HERPES
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
SHORTENED DOSING REGIMEN TO 5 DAYS FOR THE TREATMENT OF ACUTE EXACERBATION OF CHRONIC
BRONCHITIS
80MG ONCE DAILY DOSING REGIMEN
EIGHT WEEK DOSING REGIMEN
INFORMATION REGARDING INCREASED RATE OF INFUSION FOR DEPACON
ONCE A WEEK DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
ONCE A WEEK DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
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 NEW CYCLE
FOR USE ON AN "AS NEEDED" OR PRN BASIS FOR THE MANAGEMENT OF NASAL SYMPTOMS IN PATIENTS
FOR WHOM THE DRUG IS INDICATED
ADDITION OF 20MG AND 40MG DAILY AS OPTIONAL STARTING DOSES WITH 40MG INTENDED FOR
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
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

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 3 of 51

EXCLUSIVITY DOSING SCHEDULE

D-80
D-81
D-82
D-83
D-84

D-85
D-86
D-87
D-88
D-89
D-90
D-91
D-92
D-93
D-94
D-95
D-96
D-97

D-98
D-99
D-100
D-101
D-102
D-103

D-104
D-105
D-106

D-107

D-108
D-109

D-110
D-111
D-112
D-113
D-114
D-115
D-116

CHANGE OF DOSING SCHEDULE FOR LANTUS FROM ONCE DAILY AT BEDTIME TO FLEXIBLE DAILY DOSING
NEW LOWER STARTING DOSE FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPORSIS
USE OF PREMARIN 0.3 MG AND 0.45 MG FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
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
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
FOR USE IN SELECT EXTERNAL INSULIN PUMPS
ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH
OSTEOPOROSIS
NEW DOSING RANGE OF 200-400MG PER DAY IN TWO DIVIDED DOSES FOR ADULTS WITH PARTIAL
SEIZURES
USE OF REYATAZ 300 MG/RITONAVIR 100 MG ONCE DAILY FOR TREATMENT IN HIV-INFECTED
ANTIRETROVIRAL-EXPERIENCED PATIENTS
ADDITION OF DAYTIME ADMINISTRATION TO TREAT VULVOVAGINAL CANDIDIASIS
ALTERNATE INTERMITTENT DOSING REGIMEN
ALTERNATIVE DOSAGE OF 1000MG ONCE DAILY AT BEDTIME
ALTERNATE TWO OR THREE TIMES DAILY DOSING REGIMENS
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
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
DOSING FOR PED SURGICAL PTS EXPANDED TO INCLUDE PTS 1 MONTH UP TO BUT NOT INCLUDING 2
YEARS OF AGE
ONCE DAILY ADMINISTRATION FOR THE TREATMENT OF HIV INFECTION IN THERAPY NAIVE ADULT
PATIENTS
750 MG ONCE DAILY FOR FIVE DAYS FOR THE TREATMENT OF ACUTE BACTERIAL SINUSITIS
ONCE DAILY IN CHRONIC IDIOPATHIC UTICARIA FOR ADULTS AND CHILDREN 12 YEARS OF AGE AND
OLDER
NEW DOSING REGIMEN OF ONE SPRAY TWICE DAILY FOR SEASONAL ALLERIC RHINITIS IN PATIENTS 12
YRS OF AGE AND OLDER
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.
0.5MG/0.1MG FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH
MENOPAUSE IN WOMEN WHO HAVE A UTERUS
USE OF ACTONEL 75MG TWO CONSECUTIVE DAYS PER MONTH FOR THE PREVENTION AND TREATMENT OF
POSTMENOPAUSAL OSTEOPOROSIS
FIVE DAY TREATMENT OF SELECTED SUSCEPTIBLE STRAINS OF STREPTOCOCCUS PNEUMONIAE,
HAEMOPHILUS INFLUENZA, MYCOPLASMA PNEUMONIAE, AND CHLAMYDIA PNEUMONIAE FOR COMMUNITYACQUIRED 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
TREATMENT OF COMPLICATED URINARY TRACT INFECTION AND ACUTE PYELONEPHRITIS WITH 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
TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGED 13-17
PROVIDES FOR ONCE DAILY USE OF CIALIS, 2.5 MG AND 5 MG, FOR THE TREAMTENT OF ERECTILE
DYSFUNCTION
PROVIDES FOR PEDIATRIC PUMP USE
ONCE DAILY DOSING REGIMEN FOR PATIENTS WHO BECOME CONSTIPATED ON TWICE DAILY REGIMEN
NEW DOSING RECOMMENDATIONS FOR USE OF SIROLIMUS IN COMBINATION WITH CYCLOSPORINE FOR THE
PROPHYLAXIS OF REJECTION IN HIGH-RISK RENAL TRANSPLANT RECIPIENTS
STARTING DOSE OF 15MG/DAY FOR MONOTHERAPY IN ACUTE TREATMENT OF BIPOLAR DISORDER, MANIC
OR MIXED
ALTERNATIVE DOSING REGIMEN ATAZANAVIR SULATE CO-ADMINISTERED WITH RITONAVIR FOR THE
TREATMENT OF HIV-1 INFECTION IN TREATMENT NAIVE PATIENTS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 4 of 51

EXCLUSIVITY DOSING SCHEDULE

D-117
D-118
D-119
D-120
D-121
D-122
D-123
D-124
D-125

D-126
D-127
D-128

D-129
D-130

D-131
D-132
D-133

50 MG TABLET FOR INITIATION OF DOSE TITRATION FOR BIPOLAR DISORDER

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
DOSING REGIMEN ADJUSTMENTS
CHANGE TO REMOVE 20 MG MAXIMUM DOSAGE RESTRICTION
USE OF VAGIFEM 10 MCG FOR THE TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
ALTERNATIVE DOSING REGIMEN DOSE OF 20 MG/METER SQUARE BY CONTINUOUS INTRAVENOUS INFUSION
OVER 1 HOUR REPEATED DAILY FOR 5 DAYS
ONCE DAILY DOSING REGIMEN IN ADULT PATIENTS WITH LESS THAN THREE LOPINAVIR RESISTANCEASSOCIATED SUBSTITUTIONS
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
CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT PATIENTS AT HIGH RISK.
CHANGE DOSAGE REGIMEN FROM 250MG TO 500MG
DOSING REGIMEN FOR ADULT PATIENTS WITH CHRONIC HEPATITIS B (CHB) AND DECOMPENSATED LIVER
DESEASE
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
800/100 MG DARUNAVIR/RITONAVIR, ONCE DAILY, IN TREATMENT -EXPERIENCED HIV-1 INFECTED
PATIENTS WITH NO DARUNIVIR RESISTANCE ASSOCIATED SUBSITUTIONS
DOSING RECOMMENDATIONS FOR TREATMENT OF HIV-1 INFECTION DURING PREGNANCY BASED ON 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
45MG FOR 6 MONTH ADMINISTRATION
NEW EFFICACY DATA AND DOSING REGIMEN FOR PREGNANCY IN NORMAL OVULATORY WOMEN UNDERGOING
CONTROLLED OVARIAN STIMULATION AS PART OF AN IVF OR INTRACYTOPLASMIC SPERM INJECTION
(ICSI) CYCLE

EXCLUSIVITY INDICATION
I-1
I-2
I-3
I-4
I-5
I-6
I-7
I-8
I-9
I-10
I-11
I-12
I-13
I-14
I-15
I-16
I-17
I-18
I-19
I-20
I-21

I-22
I-23
I-24
I-25

DYSMENORRHEA
CHOLANGIOPANCREATOGRAPHY
INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
PERIPHERAL VENOGRAPHY (PHLEBOGRAPHY)
HYSTEROSALPINGOGRAPHY
TREATMENT OF JUVENILE ARTHRITIS
BIOPSY PROVEN MINIMAL CHANGE NEPHROTIC SYNDROME IN CHILDREN
ADULT INTRAVENOUS CONTRAST-ENHANCED COMPUTED TOMOGRAPHY OF THE HEAD AND BODY
PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
PREVENTION OF POSTOPERATIVE DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM IN TOTAL HIP
REPLACEMENT SURGERY
RELIEF OF MILD TO MODERATE PAIN
TREATMENT OF CUTANEOUS CANDIDIASIS
URINARY TRACT INFECTION (UTI) PREVENTION FOR PERIODS UP TO FIVE MONTHS IN WOMEN WITH A
HISTORY OF RECURRENT UTI
SEBORRHEIC DERMATITIS
PHOTOPHERESIS IN THE PALLIATIVE TREATMENT OF SKIN MANIFESTATIONS OF CUTANEOUS T-CELL
LYMPHOMA IN PERSONS NOT RESPONSIVE TO OTHER TREATMENT
STIMULATE THE DEVELOPMENT OF MULTIPLE FOLLICLES/OOCYTES IN OVULATORY PATIENTS
PARTICIPATING IN AN IN VITRO FERTILIZATION PROGRAM
MANAGEMENT OF CONGESTIVE HEART FAILURE
ENDOSCOPIC RETROGRADE PANCREATOGRAPHY
HERNIOGRAPHY
KNEE ARTHROGRAPHY
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
RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY IN OSTEOSARCOMA
SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
TREATMENT OF RHEUMATOID ARTHRITIS
ADULT INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY OF THE HEAD, NECK, ABDOMINAL, RENAL
AND PERIPHERAL VESSELS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 5 of 51

EXCLUSIVITY INDICATION
I-26
I-27
I-28
I-29
I-30
I-31
I-32
I-33
I-34
I-35
I-36
I-37
I-38
I-39
I-40
I-41
I-42
I-43
I-44
I-45
I-46
I-47
I-48
I-49
I-50
I-51
I-52
I-53
I-54
I-55
I-56
I-57
I-58
I-59
I-60
I-61
I-62
I-63
I-64
I-65
I-66
I-67
I-68
I-69

I-70
I-71
I-72
I-73
I-74
I-75
I-76

TREATMENT OF LIVER FLUKES

ADJUNCTIVE THERAPY TO DIET TO REDUCE THE RISK OF CORONARY ARTERY DISEASE
SELECTIVE ADULT VISCERAL ARTERIOGRAPHY
METASTATIC BREAST CANCER IN PREMENOPAUSAL WOMEN AS AN ALTERNATIVE TO OOPHORECTOMY OR
OVARIAN IRRADIATION
TREATMENT OF TINEA PEDIS
CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS IN THE SPINE AND
ASSOCIATED TISSUES
PEDIATRIC MYELOGRAPHY
ORAL USE OF DILUTED OMNIPAQUE INJECTION IN ADULTS FOR CONTRAST ENHANCED COMPUTED
TOMOGRAPHY OF THE ABDOMEN
ORAL USE IN ADULTS FOR PASS-THROUGH EXAMINATION OF THE GASTROINTESTINAL TRACT
PEDIATRIC CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING
ARTHROGRAPHY OF THE SHOULDER JOINTS IN ADULTS
RADIOGRAPHY OF THE TEMPOROMANDIBULAR JOINT IN ADULTS
CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS OF THE CENTRAL NERVOUS
SYSTEM IN CHILDREN (2 YEARS OF AGE AND OLDER)
TREATMENT OF ACUTE MYOCARDIAL INFARCTION
PRIMARY NOCTURNAL ENURESIS
MIGRAINE HEADACHE PROPHYLAXIS
HERPES ZOSTER
HERPES SIMPLEX ENCEPHALITIS
MAINTENANCE THERAPY IN HEALED DUODENAL ULCER PATIENTS AT DOSE OF 1 GRAM TWICE DAILY
ACUTE TREATMENT OF VARICELLA ZOSTER VIRUS
USE IN PEDIATRIC COMPUTED TOMOGRAPHIC HEAD AND BODY IMAGING
TREATMENT OF PEDIATRIC PATIENTS WITH SYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS (HIV)
DISEASE
PEDIATRIC ANGIOCARDIOGRAPHY
TREATMENT OF TRAVELERS' DIARRHEA DUE TO SUSCEPTIBLE STRAINS OF ENTEROTOXIGENIC
ESCHERICHIA COLI
FOR USE IN WOMEN WITH AXILLARY NODE-NEGATIVE BREAST CANCER
TREATMENT OF PRIMARY DYSMENORRHEA AND FOR THE TREATMENT OF IDIOPATHIC HEAVY MENSTRUAL
BLOOD LOSS
PEDIATRIC EXCRETORY UROGRAPHY
TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA
RENAL CONCENTRATION CAPACITY TEST
HYPERTENSION
EROSIVE GASTROESOPHAGEAL REFLUX DISEASE
SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER
INITIAL TREATMENT OF ADVANCED OVARIAN CARCINOMA IN COMBINATION WITH OTHER APPROVED
CHEMOTHERAPEUTIC AGENTS
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
FEMALE ANDROGENETIC ALOPECIA
PREVENTION AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
ONCE DAILY TREATMENT AS INITIAL THERAPY IN THE TREATMENT OF HYPERTENSION
PREVENTION OF SUPRAVENTRICULAR TACHYCARDIAS
PREVENTION OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
UNCOMPLICATED GONORRHEA
TREATMENT OF ACUTE ASTHMATIC ATTACKS IN CHILDREN SIX YEARS OF AGE AND OLDER
CENTRAL PRECOCIOUS PUBERTY
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
USE IN COMBINATION WITH 5-FLUOROURACIL TO PROLONG SURVIVAL IN THE PALLIATIVE TREATMENT
OF PATIENTS WITH ADVANCED COLORECTAL CANCER
VARICELLA INFECTIONS (CHICKENPOX)
PREVENTION OF CMV DISEASE IN TRANSPLANT PATIENTS AT RISK FOR CMV DISEASE
INITIATE AND MAINTAIN MONITORED ANESTHESIA CARE (MAC) SEDATION DURING DIAGNOSTIC
PROCEDURES
INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
TREATMENT OF ENDOSCOPICALLY DIAGNOSED EROSIVE ESOPHAGITIS
PREVENTION OF OSTEOPOROSIS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 6 of 51

EXCLUSIVITY INDICATION
I-77
I-78
I-79
I-80
I-81
I-82
I-83
I-84
I-85
I-86
I-87
I-88
I-89
I-90
I-91
I-92
I-93
I-94
I-95
I-96
I-97
I-98
I-99
I-100
I-101
I-102
I-103

I-104
I-105
I-106
I-107
I-108
I-109
I-110
I-111
I-112
I-113
I-114
I-115
I-116
I-117
I-118
I-119
I-120
I-121
I-122
I-123
I-124

DERMAL INFECTIONS-TINEA PEDIS, TINEA CORPORIS, TINEA CRURIS DUE TO EPIDERMOPHYTON

FLOCCOSUM
CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY AND INTRAVENOUS
EXCRETORY UROGRAPHY
MANAGEMENT OF CHRONIC STABLE ANGINA AND ANGINA DUE TO CORONARY ARTERY SPASM
DIAGNOSIS AND LOCALIZATION OF ISCHEMIA AND CORONARY HEART DISEASE
PROPHYLAXIS IN DESIGNATED IMMUNOCOMPROMISED CONDITIONS TO REDUCE THE INCIDENCE OF
OROPHARYNGEAL CANDIDIASIS
TREATMENT OF TRAVELERS' DIARRHEA
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
TREATMENT OF SECONDARY CARNITINE DEFICIENCY
RENAL IMAGING AGENT FOR USE IN CHILDREN
MANAGEMENT OF ENDOMETRIOSIS
EPIDURAL USE IN LABOR AND DELIVERY AS AN ANALGESIC ADJUNCT TO BUPIVACAINE
INTENSIVE CARE UNIT SEDATION
MONOTHERAPY USE FOR HYPERTENSION
ADJUNCTIVE THERAPY IN THE MANAGEMENT OF HEART FAILURE
PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN CHILDREN AGES 4-11 YEARS
USE WITH MRI IN ADULTS TO PROVIDE CONTRAST ENHANCEMENT AND FACILITATE VISUALIZATION OF
LESIONS IN THE BODY [EXCLUDING THE HEART]
TREATMENT OF LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION
TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
ORAL OR RECTAL USE IN CHILDREN FOR THE EXAMINATION OF THE GASTROINTESTINAL TRACT
TREATMENT OF CHILDREN WHO HAVE GROWTH FAILURE ASSOCIATED WITH CHRONIC RENAL INSUFFICIENCY
PEDIATRIC ANESTHESIA IN CHILDREN 3 YEARS AND OLDER
TO DECREASE THE INCIDENCE OF CANDIDIASIS IN PATIENTS UNDERGOING BONE MARROW
TRANSPLANTATION WHO RECEIVE CYTOTOXIC CHEMOTHERAPY AND/OR RADIATION THERAPY
TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN-DEPENDENT DIABETES
MELLITUS AND RETINOPATHY
TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER
PROPHYLAXIS AGAINST PNEUMOCYSTIS CARINII PNEUMONIA IN INDIVIDUALS WHO ARE
IMMUNOCOMPROMISED AND CONSIDERED TO BE AT RISK OF DEVELOPING PNEUMOCYSTIS CARINII
PNEUMONIA
TREATMENT OF PULMONARY AND EXTRAPULMONARY ASPERGILLOSIS IN PATENTS WHO ARE INTOLERANT OF
OR WHO ARE REFRACTORY TO AMPHOTERICIN B THERAPY
TREATMENT OF METASTATIC CARCINOMA OF THE BREAST AFTER FAILURE OF FIRST-LINE OR
SUBSEQUENT CHEMOTHERAPY
TREATMENT OF ACROMEGALY
VAGINAL CANDIDIASIS
EXPANDED USE-FOR ICU PATIENTS UNDERGOING LONG-TERM INFUSION DURING MECHANICAL VENTILATION
TYPHOID FEVER
PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIOTHERAPY
TREATMENT OF PAGET'S DISEASE OF BONE
MANAGEMENT OF MODERATE TO SEVERE PAIN
TREATMENT OF PROSTATITIS
USE IN CHILDREN TO VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE BRAIN
(INTRACRANIAL LESIONS), SPINE, AND ASSOCIATED TISSUE
USE IN MRI IN ADULTS TO VISUALIZE LESIONS IN THE HEAD AND NECK
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
TO SLOW THE PROGRESSION FO CORONANY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY HEART
DISEASE
PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM FOLLOWING KNEE
REPLACEMENT SURGERY
TREATMENT OF ANEMIA CAUSED BY UTERINE LEIOMYOMATA IN WOMEN WHO FAIL IRON THERAPY
MAINTENANCE THERAPY FOR GASTRIC ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING ACUTE
ULCERS
EXPANDED PATIENT POPULATION -- USE IN ICU PATIENTS
PSORIASIS OF THE SCALP
RELIEF OF MILD TO MODERATE PAIN IN PATIENTS AGED 6 MONTHS AND OLDER
LEUCOCYTE LABELED SCINTIGRAPHY AS AN ADJUNCT IN THE LOCALIZATION OF INTRA-ABDOMINAL
INFECTION AND INFLAMMATORY BOWEL DISEASE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 7 of 51

EXCLUSIVITY INDICATION
I-125
I-126
I-127
I-128

I-129
I-130
I-131
I-132
I-133
I-134
I-135
I-136
I-137
I-138
I-139
I-140
I-141
I-142
I-143
I-144
I-145
I-146
I-147
I-148
I-149
I-150
I-151
I-152
I-153
I-154
I-155
I-156
I-157
I-158
I-159

I-160
I-161
I-162
I-163
I-164
I-165

I-166
I-167
I-168
I-169
I-170
I-171

EXPANSION OF CONSCIOUS SEDATION INDICATION TO INCLUDE SHORT THERAPEUTIC PROCEDURES

ADJUNCT TO THALLIUM- 201 MYOCARDIAL PERFUSION IN PATIENTS UNABLE TO EXERCISE ADEQUATELY
TREATMENT OF ACYCLOVIR-RESISTANT HERPES IN IMMUNOCOMPROMISED PATIENTS
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...
TREATMENT OF ALCOHOL DEPENDENCE
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
PERIPHERAL ARTERIOGRAPHY
TREATMENT OF MANIC PHASE OF BIPOLAR DISORDER
MANAGEMENT OF CHRONIC STABLE ANGINA
HEART FAILURE POST MYOCARDIAL INFARCTION
BONE METASTASES ASSOCIATED WITH MULTIPLE MYELOMA
IDIOPATHIC CHRONIC URTICARIA
PREVENTION OF METAL-INDUCED HEART BURN, ACID INDIGESTION, AND SOUR STOMACH WHEN TAKEN 30
MINUTES PRIOR TO CONSUMING FOOD OR BEVERAGES
TREATMENT OF ACUTE RECURRENT GENITAL HERPES
PALLIATIVE TREATMENT OF ADVANCED BREAST CANCER IN PRE- AND PERIMENOPAUSAL WOMEN
PREVENTION OF CYTOMEGALOVIRUS (CMV) DISEASE IN INDIVIDUALS WITH HIV INFECTION AT RISK
FOR DEVELOPING CMV DISEASE
TREATMENT OF HEMODYNAMICALLY STABLE PATIENTS WITHIN 24 HOURS OF ACUTE MYOCARDIAL
INFARCTION TO IMPROVE SURVIVAL
LOCALIZE MYOCARDIAL ISCHEMIA(REVERSIBLE DEFECT) AND INFARCTION (NON-REVERSIBLE DEFECTS)
IN EVALUATING MYOCARDIAL FUNCTION
EPISODIC TREATMENT OF RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT ADULTS
ENHANCEMENT OF MRI OF THE ADULT BODY INTERNAL ORGANS
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
PREVENTION OF GALLSTONE FORMATION IN OBESE PATIENTS EXPERIENCING RAPID WEIGHT LOSS
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
TREATMENT OF OBSESSIVE COMPULSIVE DISORDER AND PANIC DISORDER
PREVENTION OF AND PREVENTION OF FURTHER POSTOPERATIVE NAUSEA AND VOMITING IN PEDIATRIC
PATIENTS RECEIVING GENERAL ANESTHESIA
SLOWING THE PROGRESSION OF CORONARY ATHEROSCLEROSIS AND REDUCING THE RISK OF ACUTE
CORONARY EVENTS
MANAGEMENT OF SEVERE SPASTICITY [ENCOMPASES SPINAL AND CEREBRAL ORIGIN]
PATIENT POPULATION ALTERED TO INCLUDE PEDIATRIC USE
TREATMENT OF ONCHOMYCOSIS DUE TO DERMATOPHYTES (TINEA UNGUIUM) OF THE TOENAIL WITH OR
WITHOUT FINGERNAIL INVOLVEMENT
ADDITIONAL DATA REGARDING THE SAFE USE OF NORVASC IN PATIENTS WITH HEART FAILURE
TREATMENT OF ACUTE UNCOMPLICATED CYSTITIS IN FEMALES
TREATMENT OF OSTEOLYTIC BONE METASTASES OF BREAST CANCER
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
TREATMENT OF BACTERIAL CORNEAL ULCERS
TREATMENT OF ADULT-ONSET OR CHILDHOOD-ONSET ADULT GROWTH HORMONE DEFICIENCY
FOR USE IN PATIENTS 6-11 YEARS OF AGE
TREATMENT OF PHOTOPHOBIA
CHRONIC BACTERIAL PROSTATITIS
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
TREATMENT OF BULIMIA
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
PROPHYLACTIC USE DURING HEAD LICE EPIDEMICS
RELIEF OF SYMPTOMS OF THE COMMON COLD

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 8 of 51

EXCLUSIVITY INDICATION
I-172
I-173
I-174
I-175
I-176
I-177

I-178
I-179
I-180
I-181
I-182
I-183
I-184
I-185
I-186
I-187
I-188
I-189
I-190

I-191
I-192

I-193
I-194
I-195

I-196
I-197
I-198

I-199
I-200
I-201
I-202
I-203
I-204
I-205
I-206
I-207
I-208
I-209
I-210

I-211
I-212
I-213
I-214

TREATMENT OF INITIAL EPISODE OF GENITAL HERPES

PREOPERATIVELY FOR THE PREVENTION OF INFECTION IN TRANSRECTAL PROSTATE BIOPSY
PELVIC INFLAMMATORY DISEASE
TREATMENT OF TINEA CORPORIS AND TINEA CRURIS
TREATMENT OF POSTOPERATIVE INFLAMMATION IN PATIENTS WHO HAVE UNDERGONE CATARACT
EXTRACTION
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
TREATMENT OF ONCHOMYCOSIS OF THE FINGERNAIL WITHOUT CONCOMITANT ONCHOMYCOSIS OF THE
TOENAIL WITH A PULSE DOSING REGIMEN
NOSOCOMIAL PNEUMONIA-MILD TO MODERATE AND SEVERE CAUSED BY HAEMOPHILUS INFLUENZAE OR
KLEBSIELLA PNEUMONIAE
TREATMENT OF PLANTAR TINEA PEDIS (MOCCASIN TYPE)
TREATMENT OF PATIENTS WITH COMPLEX PARTIAL SEIZURES WITH AND WITHOUT SECONDARY
GENERALIZATION
TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME
MAINTENANCE THERAPY IN THE MANAGEMENT OF MILD TO MODERATE ASTHMA IN PEDIATRIC PATIENTS
AGES 6-11
TREATMENT OF PANIC DISORDER AT A RECOMMENDED DOSE RANGE OF 1 TO 2MG/DAY (MAXIMUM OF 4MG)
PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
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
TREATMENT OF ACUTE SINUSITIS AND ACUTE EXACERBATION OF CHRONIC SINUSITIS
TREATMENT OF ACUTE OTITIS MEDIA IN PEDIATRIC PATIENTS
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
ENDOMETRIAL THINNING AGENT PRIOR TO ENDOMETRIAL ABLATION FOR DYSFUNCTIONAL UTERINE
BLEEDING
THE PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM, IN
PATIENTS UNDERGOING ABDOMINAL SURGERY WHO ARE AT RISK FOR THROMBOEMBOLIC 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
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
ACUTE TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
MAINTENANCE OF HEALING OF DUODENAL ULCER
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
MONOTHERAPY AND COMBINATION THERAPY WITH SULFONYL UREAS IN THE TREATMENT OF TYPE II
DIABETES
TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR
EMPIRICAL THERAPY FOR FEBRILE NEUTROPENIC PATIENTS
SECOND-LINE TREAMENT OF AIDS-RELATED KAPOSI'S SARCOMA
MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
USE IN PEDIATRIC PATIENTS BETWEEN THE AGES OF 6 AND 11 FOR THE TREATMENT OF THE NASAL
SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS
INITIAL ANTICONVULSANT TREATMENT OF STATUS EPILEPTICUS
TREATMENT OF EDEMA ASSOCIATED WITH CHRONIC RENAL FAILURE
FOR THE SUPPRESSION OF RECURRENT EPISODES OF GENITAL HERPES IN IMMUNOCOMPETENT ADULTS
TREATMENT OF OBSESSIVE COMPULSIVE DISORDER IN THE PEDIATRIC POPULATION
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
FOR USE IN PEDIATRIC POPULATION
TREATMENT OF SYMPTOMS OF DRY MOUTH IN PATIENTS WITH SJOGREN'S SYNDROME
TEMPORARY RELIEF OF PAIN AND PHOTOPHOBIA IN PATIENTS UNDERGOING CORNEAL REFRACTIVE
SURGERY
TREATMENT OF OSTEOPOROSIS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 9 of 51

EXCLUSIVITY INDICATION
I-215
I-216

I-217
I-218
I-219
I-220
I-221

I-222
I-223
I-224
I-225
I-226
I-227
I-228
I-229
I-230

I-231
I-232
I-233

I-234

I-235
I-236
I-237
I-238
I-239
I-240

I-241

I-242
I-243
I-244
I-245
I-246
I-247
I-248

PRE-PROCEDURAL APPLICATION TO ADULT MALE GENITAL SKIN PRIOR TO SITE-SPECIFIC

SUBCUTANEOUS INFILTRATION WITH LIDOCAINE FOR THE REMOVAL OF GENITAL WARTS
FOR THE LONG-TERM TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE MAINTENANCE
TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD, INCLUDING CHRONIC BRONCHITIS AND
EMPHYSEMA
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
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
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 NONALLERGICPERENNIAL RHINITIS IN CHILDREN AGE 6-11 YEARS
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
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
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
PRILOSEC (OMEPRAZOLE), AMOXICILLIN, AND CLARITHROMYCIN FOR THE ERADICATION OF H. PYLORI
IN PATIENTS WITH DUODENAL ULCER DISEASE
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 AND/OR
RADIATION
TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER AFTER FAILURE OF
PRIOR CHEMOTHERAPY
TREATMENT OF RECURRENT MUCOCUTANEOUS HERPES SIMPLEX INFECTIONS IN HIV-AFFECTED PATIENTS
AT A DOSE OF 500MG TWICE DAILY
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
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
PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 12 YEARS OF AGE AND OLDER
PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
MAINTENANCE TREATMENT OF ASTHMA AND PREVENTION OF BRONCHOSPASM IN PATIENTS 4 YEARS OF
AGE AND OLDER
ADJUNCTIVE TREATMENT OF LENNOX-GASTAUT SYNDROME IN PEDIATRIC AND ADULT PATIENTS
TREATMENT OF PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
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
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
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
USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH THE COMMON COLD IN CHILDREN
AGE 5 TO 11 YEARS
REDUCE THE INCIDENCE OF BREAST CANCER IN WOMEN AT HIGH RISK FOR BREAST CANCER
TREATMENT OF ACUTE SINUSITIS
TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
USE IN CONVERSION TO MONOTHERAPY IN ADULTS WITH PARTIAL SEIZURES WHO ARE RECEIVING
TREATMENT WITH A SINGLE ENZYME-INDUCING ANTIEPILEPTIC DRUG
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

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 10 of 51

EXCLUSIVITY INDICATION
I-249
I-250

I-251
I-252
I-253
I-254
I-255
I-256
I-257
I-258
I-259
I-260
I-261
I-262
I-263
I-264
I-265
I-266
I-267
I-268
I-269
I-270
I-271
I-272

I-273

I-274
I-275
I-276
I-277
I-278
I-279
I-280
I-281
I-282
I-283

I-284
I-285
I-286

TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS WITH COMPENSATED LIVER DISEASE PREVIOUSLY

UNTREATED WITH ALPHA INTERFERON THERAPY
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
TREATMENT OF GENERALIZED ANXIETY DISORDER
NEW COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET PLUS
METFORMIN
COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET PLUS
INSULIN
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
TREATMENT OF CHRONIC HEPATITIS B ASSOCIATED WITH EVIDENCE OF HEPATITIS B VIRAL
REPLICATION AND ACTIVE LIVER INFLAMATION
FOR PERENNIAL NONALLERGIC RHINITIS FOR AGES 4 AND ABOVE
PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM, IN
PATIENTS UNDERGOING HIP REPLACEMENT SURGERY
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
TREATMENT OR PREVENTION OF BRONCHOSPASM WITH REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE AND
FOR THE PREVENTION OF EXERCISE INDUCED BRONCHOSPASM IN CHILDREN AGES 4-12
TREATMENT OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL INFARCTION FOR THE PREVENTION OF
ISCHEMIC COMPLICATIONS IN PATIENTS ON CONCURRENT ASPIRIN THERAPY
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
USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS AGES 2-16 YEARS WITH PARTIAL
ONSET SEIZURES
USE IN PEDIATRIC PATIENTS 3 MONTHS OLD AND OLDER - FOR CORTICOSTEROID-RESPONSIVE
DERMATOSES
PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 7-11 YEARS OF AGE
PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH HIGHLY EMETOGENIC CANCER CHEMOTHERAPY,
INCLUDING CISPLATIN
ADJUVANT TREATMENT OF NODE-POSITIVE BREAST CANCER ADMINISTRERED SEQUENTIALLY TO STANDARD
DOXORUBICIN-CONTAINING COMBINATION CHEMOTHERAPY
TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
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
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)
USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONICCLONIC SEIZURES
USE IN COMBINATION WITH METFORMIN AND SULFONYLUREA IN PATIENTS WITH TYPE 2 DIABETES
USE OF REZULIN IN COMBINATION WITH METFORMIN AND SULFONYLUREAS IN PATIENTS WITH TYPE 2
DIABETES
TREATMENT OF TYPE III HYPERLIPOPROTEINEMIA
TREATMENT OF PATIENTS WITH ISOLATED HYPERTRIGLYCERIDEMIA (FREDERICKSON TYPE IV)
TREATMENT OF POST-TRAUMATIC STRESS DISORDER
USE OF CARNITOR INJECTION FOR THE PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN
PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
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
TO REDUCE THE INCIDENCE OF MODERATE TO SEVERE XEROSTOMIA IN PATIENTS UNDERGOING POSTOPERATIVE RADIATION TREATMENT FOR HEAD AND NECK CANCER, WHERE THE RADIATION PORT
INCLUDES A SUBSTANTIAL PORTION OF THE PAROTID GLANDS
TO REDUCE THE NUMBER OF ADENOMATOUS COLORECTAL POLYPS IN FAMILIAL ADENOMATOUS POLYPOSIS
PATIENTS AS AN ADJUNCT TO USUAL CARE
TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN ADULTS AND CHILDREN 3
YEARS OF AGE AND OLDER
TREATMENT OF PATIENTS WITH FREDERICKSON TYPE III

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 11 of 51

EXCLUSIVITY INDICATION
I-287
I-288

I-289

I-290
I-291
I-292
I-293
I-294
I-295
I-296

I-297
I-298
I-299
I-300
I-301
I-302
I-303
I-304
I-305
I-306
I-307
I-308
I-309
I-310
I-311
I-312
I-313
I-314
I-315

I-316

I-317
I-318
I-319
I-320
I-321
I-322
I-323
I-324

I-325
I-326
I-327

USE OF PRAVASTATIN IN PATIENTS WITH EVIDENT CORONARY HEART DISEASE TO REDUCE THE RISK OF
TOTAL MORTALITY BY REDUCING CORONARY DEATH
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
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 ADEQUATE
GLYCEMIC CONTROL
PREVENTION OF CORTICOSTEROID-INDUCED OSTEOPOROSIS
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
TREATMENT OF CORTICOSTEROID-INDUCED OSTEOPOROSIS
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
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR WOMEN WITH AN INTACT UTERUS
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
SHORT-TERM TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IIA AND IIB HYPERLIPOPROTEINEMIA
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
PROPHYLAXIS FOR ASTHMA IN CHILDREN 2-5 YEARS OF AGE
TREATMENT OF SIGNS AND SYMPTOMS OF ALLERGIC CONJUNCTIVITIS
TREATMENT OF PEDIATRIC PATIENTS WITH PRADER-WILLI SYNDROME
INCREASING HDL-CHOLESTEROL IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA AND MIXED
DYSLIPIDEMIAS
TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IV
TREATMENT OF LEVOFLOXACIN SUSCEPTIBLE STRAINS OF PENICILLIN-RESISTANT 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
NEW COMBINATION USE OF METFORMIN AND INSULIN IN TYPE 2 DIABETES
TREATMENT OF PEDIATRIC PATIENTS WITH POLYARTICULAR COURSE JUVENILE RHEUMOTOID ARTHRITIS
WHO RESPONDED INADEQUATELY TO SALICYLATES OR OTHER NSAIDS
USE OF ACTONEL 35MG ONCE A WEEK TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
REDUCTION IN RISK OF MYOCARDIAL INFARCTION, STROKE, AND DEATH FROM CARDIOVASCULAR CAUSES
ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS AGE 3 TO
12 YEARS
FIRST LINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR HORMONE
RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EXTENSION OF INDICATION TO PROVIDE FOR MAINTENANCE OF RESPONSE
TOPICAL ANESTHETIC FOR SUPERFICIAL MINOR SURGERY OF GENITAL MUCOUS MEMBRANES AND AS AN
ADJUNCT FOR LOCAL INFILTRATION ANESTHESIA IN GENITAL MUCOUS MEMBRANES
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
TREATMENT OF NSAID-ASSOCIATED GASTRIC ULCER PATIENTS WHO CONTINUE NSAID USE AND REDUCING
RISK OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS WITH HISTORY OF DOCUMENTED GASTRIC
ULCER WHO REQUIRE USE OF AN NSAID
PROPHYLAXIS OF INFLUENZA IN ADULTS AND ADOLESCENTS 13 YEARS AND OLDER
FIRSTLINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR HORMONE
RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER
USE FOR SUSPECTED OR CONFIRMED METHANOL POISONING, EITHER ALONE OR IN COMBINATION WITH
HEMODIALYSIS
TREATMENT OF TYPE 2 DIABETES IN PEDIATRIC PATIENTS (AGES 10-16 YEARS)
JUVENILE RHEUMATOID ARTHRITIS
USE OF DIPRIVAN IN PATIENTS 3 MONTHS TO 16 YEARS
COLORECTAL CANCER
REDUCING NEUROLOGIC DISABILITY AND/OR FREQUENCY OF CLINICAL RELAPSES IN PATIENTS WITH
SECONDARY (CHRONIC) PROGRESSIVE, PROGRESSIVE RELAPSING, OR WORSENING RELAPSING-REMITTING
MULTIPLE SCLEROSIS
PREVENTION OF RELAPSE AND RECURRENCE OF DEPRESSION
GENERALIZED ANXIETY DISORDER
SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN PATIENTS
5 YEARS AND OLDER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 12 of 51

EXCLUSIVITY INDICATION
I-328
I-329
I-330
I-331
I-332
I-333
I-334
I-335
I-336

I-337
I-338
I-339
I-340
I-341
I-342

I-343
I-344
I-345
I-346
I-347
I-348
I-349
I-350

I-351
I-352
I-353
I-354
I-355
I-356
I-357
I-358
I-359
I-360
I-361

I-362
I-363
I-364
I-365
I-366
I-367

I-368
I-369
I-370

PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 5-6 YEARS OF AGE

UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND CONTROL OF DAYTIME AND NIGHTTIME
HEARTBURN SYSTOMS IN PATIENTS WITH GERD
TREATMENT OF MODERATE ACNE VULGARIS
EMPIRIC THERAPY IN FEBRILE NEUTROPENIC PATIENTS WITH SUSPECTED FUNGAL INFECTIONS (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
ADJUNCTIVE THERAPY IN PATIENTS TWO YEARS AND OLDER WITH SEIZURES ASSOCIATED WITH LENNOXGASTAUT SYNDROME
EXPANSION OF INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH PREDOMINATELY CLASSIC
SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO PATHOLOGIC MYOPIA OR PRESUMED OCULAR
HISTOPLASMOSIS
PATHOLOGICAL HYPERSECRETION ASSOCIATED WITH ZOLLINGER-ELLISON SNYDROME
MANAGEMENT OF ACUTE PAIN IN ADULTS AND TREATMENT OF PRIMARY DYSMENORRHEA
TREATMENT OF HEPATITIS B IN PEDIATRIC PATIENTS AGES 2-17 YEARS
ATOPIC DERMATITIS IN PEDIATRIC PATIENTS AGES 2-5
BREAST CANCER COMBINATION THERAPY
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
USE OF COREG FOR SEVERE HEART FAILURE
ACNE VULGARIS
TREATMENT OF POSTTRAUMATIC STRESS DISORDER
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
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
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
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR ALL STRENGTHS
ANTICOAGULANT IN PATIENTS WITH OR AT RISK FOR HEPARIN-INDUCED THROMBOCYTOPENIA
UNDERGOING PERCUTANEOUS CORONARY INTERVENTIONS (PCI)
TREATMENT OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS
MANAGEMENT OF POST HERPETIC NEURALGIA
PREMENSTRUAL DYSPHORIC DISORDER
TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS, INCLUDING ZOLLINGER-ELLISON SYNDROME
TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
TREATMENT OF PANIC DISORDER
TREATMENT OF VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH THE MENOPAUSE
TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN CHILDREN AGES TWO UP
TO AGE THREE
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
TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA
ADJUVANT TREATMENT OF POST MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE EARLY BREAST
CANCER
TREATMENT OF COMMUNITY-ACQUIRED PNEUMONIA IN ADULTS
TREATMENT OF HEART FAILURE (NYHA CLASS II-IV) IN PATIENTS WHO ARE INTOLERANT TO AN ACE
INHIBITOR
PREVENTION OF RELAPSE FOLLOWING LONG-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER
COMBINATION THERAPY WITH THIAZOLIDINEDIONE TO LOWER BLOOD GLUCOSE IN PTS WHOSE
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
PREVENTION AND TREATMENT OF POSTOPERATIVE NAUSEA AND VOMITING
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

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 13 of 51

EXCLUSIVITY INDICATION
I-371
I-372
I-373
I-374
I-375
I-376
I-377

I-378
I-379

I-380
I-381
I-382
I-383
I-384
I-385
I-386

I-387
I-388
I-389
I-390

I-391
I-392

I-393
I-394
I-395
I-396
I-397
I-398
I-399
I-400
I-401
I-402
I-403

I-404

I-405
I-406

HELICOBACTER PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE

NOSOCOMIAL PNEUMONIA
TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY
SHORT TERM TOPICAL TREATMENT OF MILD TO MODERATE PLAQUE-TYPE PSORIASIS OF NON SCALP
REGIONS
FIRST LINE THERAPY FOR THE REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN-ANGLE
GLAUCOMA OR OCULAR HYPERTENSION
TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE
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
RELIEF OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS 2
YEARS OF AGE AND OLDER
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
TO TREAT PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER AT RISK FOR EMERGENT
SUICIDAL BEHAVIOR
TREATMENT OF COLD SORES (HERPES LABIALIS) IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF
AGE AND OLDER
FOR NEWLY-DIAGNOSED HIGH GRADE MALIGNANT GLIOMA PATIENTS AS AN ADJUNCT TO SURGERY AND
RADIATION
TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY
USE IN COMBINATION WITH INSULIN FOR THE TREATMENT OF PATIENTS WITH TYPE 2 DIABETES
MELLITUS
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
ADJUNCTIVE THERAPY OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS GREATER THAT OR EQUAL TO 2
YEARS OF AGE
TREATMENT OF PATIENTS WITH LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION
SUPRESSION OF RECURRENT GENITAL HERPES IN HIV-INFECTED INDIVIDUALS
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 & STROKE.....
ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO
ESOPHAGECTOMY
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
CHRONIC BACTERIAL PROSTATITIS
USE IN PATIENTS WITH CORONARY HEART DISEASE TO REDUCE THE RISK OF UNDERGOING CORONARY
REVASCULARIZATION PROCEDURES
TO IMPROVE PHYSICAL FUNCTION
EXPANDED INDICATION TO INCLUDE THE ASSESSMENT OF VENTRICULAR FUNCTION IN SUBJECTS BEING
EVALUATED FOR HEART DISEASE AND/OR VENTRICULAR FUNCTION
EXTENDED PROPHYLAXIS IN PATIENTS UNDERGOING HIP FRACTURE SURGERY
IDIOPATHIC SHORT STATURE
TREATMENT OF CANDIDEMIA AND THE FOLLOWING CANDIDA INFECTIONS: INTRA-ABDOMINAL
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
LONGER-TERM EFFICACY OF ARIPIPRAZOLE IN THE TREATMENT OF SCHIZOPHRENIA
DIABETIC FOOT INFECTIONS WITHOUT CONCOMITANT OSTEOMYELITIS
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
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
TREATMENT OF PREMENSTRUAL DYSPHORIC DISORDER (PMDD) USING AN INTERMITTENT DOSING REGIMEN
PREVENTION OF CYTOMEGALOVIRUS DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS TRANSPLANT
PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE)

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 14 of 51

EXCLUSIVITY INDICATION
I-407

I-408
I-409
I-410
I-411
I-412
I-413
I-414

I-415
I-416
I-417
I-418
I-419
I-420
I-421
I-422
I-423
I-424
I-425
I-426
I-427
I-428

I-429
I-430
I-431
I-432
I-433

I-434

I-435
I-436
I-437
I-438
I-439
I-440
I-441

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
STIMULATION OF PANCREATIC SECRETIONS TO FACILITATE THE INDENTIFICATION OF THE AMPULLA OF
VATER AND ACCESSORY PAPILLA DURING ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP)
ESOPHAGEAL CANDIDIASIS
USE OF ADVAIR DISKUS 250/50 FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ASSOCIATED
WITH CHRONIC BRONCHITIS
EXPANDED INDICATION FOR USE IN COMBINATION WITH ANTIDIABETIC DRUGS IN THE
THIAZOLIDINEDIONE CLASS
MONOTHERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED
WITH BIPOLAR I DISORDER
ADJUNCTIVE THERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES
ASSOCIATED WITH BIPOLAR I DISORDER
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
SEVERE HYPERTENSION WHEN THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL EXCEEDS
THE RISK OF INITIATING COMBINATION THERAPY
THE USE OF CIPRO XR FOR COMPLICATED URINARY TRACT INFECTIONS AND ACUTE UNCOMPLICATED
PYELONEPHRITIS
USE IN THE LONG TERM TREATMENT OF BIPOLAR I DISORDER
ADJUNCTIVE THERAPY W/ MOOD STABILIZERS (LITHIUM OR DIVALPROEX) IN THE TREATMENT OF ACUTE
MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDERS
MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
TOPICAL TREATMENT OF CLINICALLY TYPICAL, NONHYPERKERATOTIC, NONHYPERTROPHIC ACTINIC
KERATOSES ON THE FACE OR SCALP IN IMMUNOCOMPETENT ADULTS
TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND PYELONEPHRITIS DUE TO E.COLI 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
ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH MODERATE TO SEVERE CHRONIC
RENAL INSUFFICIENCY NOT YET ON DIALYSIS
FLOXATIN IN COMBINATION WITH INFUSIONAL 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV) FOR
THE TREATMENT OF PATIENTS PREVIOUSLY UNTREATED FOR ADVANCED COLORECTAL CANCER
TREATMENT OF ACUTE PULMONARY EMBOLISM WHEN ADMINISTERED IN CONJUNCTION WITH WARFARIN
SODIUM
TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITHOUT PULMONARY EMBOLISM WHEN ADMINISTERED IN
CONJUNCTION WITH WARFARIN SODIUM
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
FOR USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH ANDROGEN
INDEPENDENT (HORMONE REFRACTORY) METASTATIC PROSTATE CANCER
FOR USE IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN ADULTS
NOSOCOMIAL PNEUMONIA AND COMMUNITY-ACQUIRED PNEUMONIA CAUSED BY STREPTOCOCCUS PNEUMONIAE
INDICATION EXPANDED TO INCLUDE MULTI-DRUG RESISTANT STRAINS
TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA CAUSED BY MULTI-DRUG RESISTANT STREPTOCOCCUS
PNEUMONIAE
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
CHRONIC IDIOPATHIC CONSTIPATION
FOR USE IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE FOR THE ADJUVANT TREATMENT
OF PATIENTS WITH OPERABLE NODE-POSITIVE BREAST CANCER
TREATMENT OF ACUTE MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR DISORDER
EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE, NEUTROPENIC PATIENTS
USED TO TREAT ADULTS WITH GROWTH HORMONE DEFICIENCY
FOR THE REPLACEMENT OF ENDOGENOUS GROWTH HORMONE IN ADULTS WITH GROWTH HORMONE DEFICIENCY
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

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 15 of 51

EXCLUSIVITY INDICATION
I-442
I-443
I-444
I-445

I-446

I-447
I-448
I-449
I-450
I-451
I-452
I-453
I-454
I-455

I-456

I-457
I-458

I-459
I-460
I-461

I-462
I-463
I-464
I-465
I-466
I-467
I-468
I-469
I-470
I-471

I-472
I-473
I-474
I-475
I-476

USED FOR CANDIDEMIA IN NONNEUTROPENIC PATIENTS AND THE FOLLOWING CANDIDA 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
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
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
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
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
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
TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED HIGH GRADE GLIOMAS CONCOMITANTLY WITH
RADIOTHERAPY AND THEN AS ADJUVANT TREATMENT
MANAGEMENT OF ENDOMETRIOSIS ASSOCIATED PAIN
EXPANDED INDICATION TO INCLUDE TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED
AT LEAST 1 PRIOR THERAPY
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 THE
ILEUM AND/OR THE ASCENDING COLON FOR UP TO 3 MONTHS
MODIFIED HEART FAILURE INDICATION TO INCLUDE TREATMENT OF HEART FAILURE IN 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
TREATMENT OF PATIENTS UNDERGOING ABDOMINAL SUREGERY WHO ARE AT RISK FOR THROMBOEMBOLIC
COMPLIATIONS
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
TREATMENT OF DIARRHEA CAUSED BY CRYPTOSPORIDIUM PARVUM IN NON-HIV INFECTED PATIENTS 12
YEARS OF AGE AND OLDER
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
LONG TERM TREATMENT OF IDIOPATHIC SHORT STATURE
TREATMENT OF PATIENTS POST MYOCARDIAL INFARCTION
TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME
PERENNIAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER
FOR RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS
USE OF TOPIRAMATE AS INITIAL MONOTHERAPY IN PATIENTS 10 YEARS OF AGE AND OLDER WITH
PARTIAL ONSET OR PRIMARY GENERALIZED TONIC CLONIC SEIZURES
USE IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE TO REDUSE THE RISK OF CARDIOVASCULAR
MORTALITY OR NON-FATAL MYOCARDIAL INFECTION
RELIEF OF THE SIGNS AND SYMPTOMS OF PAUCIARTICULAR OR POLYARTICULAR COURSE JUVENILE
RHEUMATOID ARTHRITIS IN PATIENTS 2 YEARS OF AGE AND OLDER
DIABETIC PERIPHERAL NEUROPATHIC PAIN
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
USE IN PATIENTS WITH ANGIOGRAPHICALLY DOCUMENTED CORONARY ARTERY DISEASE
USE IN COMBINATION WITH GEMCITABINE FOR THE FIRST LINE TREATMENT OF PATIENTS WITH
LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC CANCER
TREATMENT OF IRON DEFICIENCY ANEMIA IN PERITONEAL DIALYSIS DEPENDANT CHRONIC KIDNEY
DISEASE IN PATIENTS RECIEVING AN ERYTHROPOIETIN
PREVENTION OF NAUSEA AND VOMITTING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF
MODERATELY EMETOGENIC CANCER CHEMOTHERAPY
TREATMENT OF DIABETIC FOOT INFECTIONS WITHOUT OSTEOMYELITIS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 16 of 51

EXCLUSIVITY INDICATION
I-477

I-478
I-479

I-480
I-481
I-482
I-483
I-484
I-485
I-486
I-487
I-488
I-489
I-490

I-491
I-492
I-493

I-494

I-495

I-496
I-497
I-498
I-499

I-500
I-501
I-502

I-503
I-504
I-505

I-506
I-507

I-508
I-509
I-510
I-511
I-512

TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY METHICILLIN

SUSCEPTIBLE STAPHYLOCOCCUS AUREUS, ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR
ENTEROBACTER CLOACAE
FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN CHILDREN WITH
EPILEPSY AGED 2-4 YEARS
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
PROPHYLAXIS OF INFLUENZA FOR PATIENTS BETWEEN 1-12 YEARS OF AGE
INDICATED FOR THE ADJUVANT TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR
POSITIVE EARLY BREAST CANCER
TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH OR
WITHOUT PSYCHOTIC FEATURES
PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
FOR THE RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS
TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO
HAVE UNDERGONE CATARACT EXTRACTION
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
MAINTENANCE THERAPY IN BIPOLAR I DISORDER
FOR USE IN PEDIATRIC PATIENTS WITH TYPE I DIABETES
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
INFLUENZA PROPHYLAXIS
MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC OR MIXED EPISODES IN BIPOLAR I 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 MIXED
HYPERLIPIDEMIA
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
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
LONG TERM TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME IN PATIENTS WHO
HAVE OPEN EPIPHYSES
PREVENTION OF SEASONAL MAJOR DEPRESSIVE EPISODES IN PATIENTS WITH SEASONAL AFFECTIVE
DISORDER
PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
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 PLATINUMBASED THERAPY
FOR USE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF MULTIPLE MYELOMA PATIENTS
WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN IMMUNOCOMPETANT PATIENTS WITH A
SINGLE DOSE OF FAMCICLOVIR 1500 MG.
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
TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER
TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME
TREATMENT OF STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA), INCLUDING THOSE
WITH RIGHT SIDED INFECTIVE ENDOCARDITIS, CAUSED BY METHICILLIN-SUSCEPTIBLE AND
METHICILLIN-RESISTANT ISOLATES
ADJUNCTIVE THERAPY OF MYOCLONIC SEIZURES IN ADULTS AND ADOLESCENTS AGE 12 AND OVER WITH
JUVENILE MYOCLONIC EPILEPSY
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
PREMENSTRUAL DYSPHONIC DISORDER
TREATMENT OF IRRATABILITY ASSOCIATED WITH AUTISTIC DISORDER
ADULT DERMAFIBROSARCOMA PROTUBERANS (DFSP)
ADULT MYELODYSPLASTIC SYNDROME/MYELOPROLIFERATIVE DISEASES (MDS/MDP)
ADULT PH+ ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) MONOTHERAPY

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 17 of 51

EXCLUSIVITY INDICATION
I-513
I-514
I-515
I-516
I-517
I-518
I-519

I-520

I-521
I-522

I-523

I-524
I-525
I-526
I-527
I-528
I-529
I-530
I-531
I-532
I-533
I-534
I-535
I-536
I-537
I-538
I-539
I-540
I-541
I-542
I-543
I-544
I-545
I-546
I-547
I-548
I-549
I-550
I-551
I-552

I-553
I-554

ADULT AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM)

ADULT HYPEREOSINOPHILIC SYNDROME/CHRONIC EOSINOPHILIC LEUKEMIA (HES/CEL)
PROPHYLAXIS OF SURGICAL SITE INFECTION FOLLOWING ELECTIVE COLORECTAL SURGERY
PRIMARY GENERALIZED TONIC CLONIC SEIZURES IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF
AGE AND OLDER
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 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 ADEQUATE
GLYCEMIC CONTROL
TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 YEAR PRIOR
THERAPY
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.
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
GENERALIZED ANXIETY DISORDER (GAD)
USE OF 0.5MG/0.1MG FOR PREVENTION OF POST-MENOPAUSAL OSTEOPOROSIS
TREATMENT OF HYPONATREMIA IN HOSPITALIZED PATIENTS
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
TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF
VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH MENOPAUSE
TREATMENT OF DEMENTIA OF THE ALZHEIMER'S TYPE IN PATIENTS WITH SEVERE ALZHEIMER'S DISEASE
PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION IN PATIENTS 15 YEARS OF AGE AND OLDER
MAINTENANCE TREATMENT OF SCHIZOPHRENIA
TREATMENT OF BACTERIAL VAGINOSIS IN NON-PREGNANT FEMALES
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
MANAGEMENT OF FIBROMYALGIA
FOR THE TREATMENT OF SHORT STATURE IN CHILDREN WITH NOONAN SYNDROME
LONG TERM TREATMENT OF PANIC DISORDER
SHORT TERM TREATMENT OF PANIC DISORDER
REDUCTION IN RISK OF INVASIVE BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS OR
AT HIGH RISK FOR INVASIVE BREAST CANCER
TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGES 13-17
TREATMENT OF BIPOLAR I DISORDER IN CHILDREN AGES 10-12 AND ADOLESCENTS AGES 13-17
EXPANSION OF PATIENT POPULATION FOR HEAD AND NECK CANCER FROM "INOPERABLE" PATIENTS TO
ALL PATIENTS
USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE INDUCTION TREATMENT OF
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
ADJUNCTIVE TREATMENT TO TREAT PATIENTS WITH MAJOR DEPRESSIVE DISORDER
TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA
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
SEASONAL ALLERGIC RHINITIS IN PATIENTS 6 THROUGH LESS THAN 12 YEARS OF AGE
USE OF AVALIDE TABLETS AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED MULTIPLE
DRUGS TO ACHIEVE THEIR BLOOD PRESSURE GOALS
TREATMENT OF HYPERTENSION IN PEDIATRIC PATIENTS 6-16 YEARS OF AGE
TREATMENT OF SHORT STATURE IN CHILDREN WITH TURNER'S SYNDROME
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
FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH
TYPE 2 DIABETES MELLITUS
TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA PERITONIS
AND ABSCESSES

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 18 of 51

EXCLUSIVITY INDICATION
I-555
I-556
I-557
I-558
I-559
I-560
I-561
I-562
I-563
I-564
I-565
I-566
I-567
I-568

I-569
I-570
I-571
I-572
I-573
I-574
I-575
I-576
I-577
I-578
I-579
I-580
I-581
I-582
I-583
I-584
I-585
I-586
I-587
I-588
I-589
I-590
I-591
I-592
I-593
I-594
I-595
I-596
I-597

TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN

PEDIATRIC PATIENTS AGED 10-17 YEARS
PREVENTION OF POST OPERATIVE NAUSEA AND VOMITING FOR UP TO 24 HOURS FOLLOWING SURGERY
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
ADJUNCTIVE THERAPY ADDED TO LITHIUM OR VALPROATE IN SHORT TERM TREATMENT OF BIPOLAR
DISORDER, MANIC OR MIXED
MAINTENANCE TREATMENT FOR BIPOLAR I DISORDER, AS ADJUNCTIVE THERAPY TO LITHIUM OR
DIVALPROEX
LONG-TERM TREATMENT OF SOCIAL ANXIETY DISORDER
MAINTENANCE TREATMENT OF ATTENTION-DEFICIT DISORDER (ADHD) IN CHILDREN AND ADOLESCENTS
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
TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
USE OF DUTASTERIDE IN COMBINATION WITH TAMSULOSIN FOR THE TREATMENT OF SYMPTOMATIC
BENIGN PROSTATIC HYPERPLASIA (BPH)
MANAGEMENT OF FIBROMYALGIA
INITIAL THERAPY IN PATIENTS LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD
PRESSURE GOALS
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
TREATMENT OF CHRONIC HEPATITIS B
TREATMENT OF CHICKEN POX IN IMMUNOCOMPETENT PEDIATRIC PATIENTS 2 TO <18 YEARS OF AGE
NON-SMALL CELL LUNG CANCER IN COMBINATION WITH CISPLATIN AND AS SINGLE AGENT FOR
NONSQAUMOUS NON-SMALL CELL LUNG CANCER
TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA) WITH NO
CATCH-UP BY AGE 2-4 YRS.
TO TREAT PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDICKSON TYPE III
HYPERLIPOPROTEINEMIA) AS AN ADJUNCT TO DIET
MONOTHERAPY IN THE TREATMENT OF BIPOLAR DEPRESSION
MONOTHERAPY IN THE TREATMENT OF BIPOLAR MANIA
ADJUNCTIVE THERAPY IN THE TREATMENT OF BIPOLAR MANIA
SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER PROCUDURES
EXPANSION OF INDICATION TO INCLUDE TREATMENT OF HIV IN TREATMENT NAIVE ADULTS
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
INDOLENT B-CELL NON-HODGKINS LYMPHOMA (NHL) THAT HAS PROGRESSED DURING OR WITHIN SIX
MONTHS OF TREATMENT WITH RITUXIMAB OR A RITUXIMAB CONTAINING REGIMEN
TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
ADJUVANT TREATMENT OF ADULT PATIENTS FOLLOWING COMPLETE GROSS RESECTION OF KIT (CD117)
POSITIVE GASTOINTESTINAL STROMAL TUMORS (GIST)
TREATMENT AND PREVENTION OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN PATIENTS EXPECTED TO
BE ON GLUCOCORTICOIDS FOR AT LEAST 12 MONTHS
TREATMENT OF SHORT STATURE IN PEDIATRIC PATIENTS SMALL FOR GESTATIONAL AGE WHO DO NOT
MANIFEST CATCH UP GROWTH BY AGE 2 TO 4 YEARS
COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
ADDITIONAL PATHOGENS TO COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS INDICATION
ADDITIONAL PATHOGENS TO COMPLICATED INTRA-ABDOMINAL INFECTIONS INDICATION
TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH OLANZAPINE
ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN COMBINATION
WITH OLANZAPINE)
TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH FLUOXETINE
ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN COMBINATION
WITH FLUOXETINE)
TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD)
INDICATION EXPANDED TO INCLUDE PATIENTS WHO HAVE EXPERIENCED A FIRST CLINICAL EPISODE
AND HAVE MRI FEATURES CONSISTENT WITH MULTIPLE SCLEROSIS
PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
USE AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE FOR THE MAINTENANCE TREATMENT OF
BIPOLAR I DISORDER
MONOTHERAPY FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 19 of 51

EXCLUSIVITY INDICATION
I-598
I-599
I-600
I-601

I-602
I-603
I-604
I-605
I-606
I-607
I-608

I-610
I-611

I-612

I-613
I-614
I-615
I-616
I-617
I-618
I-619
I-620

I-621

I-622
I-623
I-624

I-625
I-626
I-627
I-628
I-629
I-630

I-631
I-632
I-633
I-634

TREATMENT OF PULMONARY ARTERIAL HYPERTENSION INDICATION EXPANDED TO INCLUDE DELAY IN

CLINICAL WORSENING
PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY
DISEASE (CKD) STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS
FOR USE AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE
THEIR BLOOD PRESSURE GOALS
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
TREATMENT OF MEN AND WOMEN WITH OSTEOPOROSIS ASSOCIATED WITH SUSTAINED SYSTEMIC
GLUCOCORTICOID THERAPY AT HIGH RISK FOR FRACTURE
GOUT FLARES
PREVENTION OF CMV DISEASE IN KIDNEY AND HEART TRANSPLANT PATIENTS 4 MONTHS TO 16 YEARS
AT HIGH RISK
ADJUNCT TO MOOD STABILIZERS AND/OR ANTIDEPRESSANTS FOR SCHIZOAFFECTIVE DISORDER
TREATMENT OF SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY
INDICATION EXPANDED TO INCLUDE TREATMENT OF PULMONARY ARTENAL HYPERTENSION (WHO GROUP I)
IN PATIENTS WITH CLASS II SYMPTOMS
REDUCE LDL-C LEVELS IN BOYS AND POSTMENARCHAL GIRLS, 10 TO 17 YEARS OF AGE, WITH
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA AS MONOTHERAPY OR IN COMBINATION WITH A
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
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
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
MILD TO MODERATE ATOPIC DERMATITIS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 18 YEARS OF
AGE
SHORT TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD IN PEDIATRIC PATIENTS
AGES FIVE YEARS AND OLDER
MAINTENANCE TREATMENT OF BIPOLAR DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE
TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 617 YEARS OF AGE
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
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
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
TREATMENT OF SIGNS AND SYMPTOMS OF ADVANCED IDIOPATHIC PARKINSON'S DISEASE
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 FIRSTLINE CHEMOTHERAPY
PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY
RELIEF OF NASAL CONGESTION ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS AND
PEDIATRIC PATENTS 2 YEARS OF AGE AND OLDER
TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE
CHRONIC MYELOID LEUKEMIA (PH & CML) IN CHRONIC PHASE.
MAINTENANCE TREATMENT OF SCHIZOPHRENIA IN ADULTS
ADJUNCTIVE THERAPY WITH EITHER LITHIUM OR VALPROATE FOR THE ACUTE TREATMENT OF MANIC OR
MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
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.
PREVENTION OF RELAPSE TO OPIOID DEPENDENCE FOLLOWING OPIOID DETOXIFICATION
MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN
MAINTENANCE TREATMENT OF BIPOLAR I DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE
TREATMENT OF SEVERE HYPERCALCEMIA IN PATIENTS WITH PRIMARY HYPERPARATHYROIDISM WHO ARE
UNABLE TO UNDERGO PARATHYROIDECTOMY

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 20 of 51

EXCLUSIVITY INDICATION
I-635
I-636
I-637
I-638
I-639
I-640
I-641
I-642
I-643
I-644

ADJUNCTIVE TREATMENT WITH LONG-ACTING ORAL PSYCHOSTIMULANTS FOR THE TREATMENT OF

ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
TREATMENT OF EXTERNAL GENITAL AND PERIANAL WARTS/CONDYLOMA ACUMINATA IN PATIENTS 12
YEARS OR OLDER
USE IN COMBINATION CHEMOTHERAPY WITH 5-FLUOROURACIL IN THE PALLIATIVE TREATMENT OF
PATIENTS WITH ADVANCED METASTATIC COLORECTAL CANCER
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
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.
MONOTHERAPY IN PATIENTS 13 YEARS OF AGE AND OLDER WITH PARTIAL SEIZURES WHO ARE
RECEIVING THERAPY WITH A SINGLE ANTIEPILEPTIC DRUG (AED)

EXCLUSIVITY MISCELLANEOUS
M-1
M-2

M-3
M-4
M-5
M-6
M-7
M-8
M-9

M-10
M-11
M-12
M-13
M-14
M-15
M-16
M-17
M-18
M-19
M-20
M-21
M-22
M-23
M-24
M-25
M-26

M-27

INFORMATION REGARDING SUPERIORITY CLAIM OVER RANITIDINE FOR DAY AND NIGHT HEARTBURN
ADDED TO CLINICAL STUDIES SECTION
APPROVAL FOR ADDTION TO CLINICAL PHARMACOLOGY SECTION OF THE LABEL REGARDING (1)
IMPROVEMENT IN BONE MINERAL DENSITY IN CHILDHOOD-ONSET ADULT GROWTH HORMONE 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
CHANGES TO PEDIATRIC USE SECTION TO PROVIDE INFORMATION REGARDING SAFETY AND EFFICACY IN
PEDIATRIC PATIENTS AS YOUNG AS 2 YEARS OLD
INFORMATION REGARDING EFFECTS IN PATIENTS WITH ASTHMA ON CONCOMITANT INHALED
CORTICOSTEROIDS IN CLINICAL PHARMACOLOGY SECTION
ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH GLUCOPHAGE/GLYBURIDE
COMBINATION ADDED TO CLINICAL PHARMACOLOGY AND DOSING AND ADMINISTRATION
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
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
USE FOR LONG-TERM TREATMENT OF POSTTRAUMATIC STRESS DISORDER
NEW LANGUAGE FOR PEDIATRIC USE
INFORMATION FROM PEDIATRIC STUDIES ADDED TO CLINICAL PHARMACOLOGY, PRECAUTIONS, AND
DOSAGE AND ADMINISTRATION
ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
LONGER TERM EFFICACY INFORMATION FOR RISPERIDONE IN THE TREATMENT OF SCHIZOPHRENIA
CHANGE IN WORDING OF THE PEDIATRIC SECTION OF THE PACKAGE INSERT
INFORMATION REGARDING USE OF ULTANE IN PEDIATRIC PATIENTS WITH CONGENITAL HEART DISEASE
INFORMATION DENOTING THE EFFICACY OF REMERON IN MAINTAINING A RESPONSE IN PATIENTS WITH
MAJOR DEPRESSIVE DISORDER (MDD)
INFORMATION REGARDING USE IN PEDIATRIC PATIENTS TWO YEARS OF AGE AND OLDER
LABELING REVISIONS RELATED TO MCCUNE ALBRIGHT SYNDROME
COMPARISON DATA ON THE ANTIHYPERTENSIVE EFFECTS OF ATACAND AND COZAAR
CHANGE IN TIME TO ONSET OF ACTION
INFORMATION REGARDING ELIMINATION ADDED TO CLINICAL PHARMACOLOGY, STUDY RESULTS IN
PATIENTS WITH HEPATIC AND RENAL IMPAIRMENT
INFORMATION ON RESULTS OF A LONG TERM LONGITUDINAL GROWTH STUDY AND PEDIATRIC SAFETY
INFORMATION
ADDITIONAL SAFETY & PK INFORMATION IN CHILDREN 6 MONTHS TO LESS THAN 6 YEARS OF AGE
ADDED TO PKG INSERT
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 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

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 21 of 51

EXCLUSIVITY MISCELLANEOUS
M-28
M-29
M-30
M-31
M-32
M-33
M-34
M-35
M-36
M-37
M-38
M-39
M-40
M-41

M-42
M-43

M-44
M-45
M-46
M-47
M-48
M-49
M-50

M-51
M-52

M-53
M-54
M-55
M-56
M-57
M-58

M-59

M-60

M-61

INFORMATION FROM A STUDY IN PEDIATRIC PATIENTS IN ASSOCIATION WITH A NEUROLOGICAL

CONDITION
LABELING CHANGES TO PROVIDE INFORMATION IN THE MANAGEMENT OF OBESITY IN ADOLESCENTS AGED
12 TO 16 YEARS
CHANGES TO CLINICAL PHARMACOLOGY, PRECAUTIONS, AND DOSAGE AND ADMINISTRATION SECTIONS OF
LABELING CONCERNING USE OF LOTENSIN IN PEDIATRIC PATIENTS WITH HYPERTENSION
INFORMATION FOR USE IN PEDIATRIC PATIENTS WITH CHRONIC KIDNEY DISEASE STAGE 5 (END-STAGE
RENAL DISEASE)
ADDITIONAL LANGUAGE TO CLINICAL PHARMACOLOGY AND CLINICAL STUDIES
INFORMATION FOR USE OF ADVAIR DISKUS 100/50 IN CHILDREN 4 TO 11 YEARS OF AGE WITH ASTHMA
EXPANDED INFORMATION TO PEDIATRIC USE SUBSECTION OF LABELING IN RESPONSE TO PEDIATRIC
WRITTEN REQUEST
ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH ACTOS IN COMBINATION WITH
METFORMIN, A SULFONYLUREA, OR INSULIN ADDED TO CLINICAL PHARMACOLOGY
ADDITION OF INFORMATION TO CLINICAL STUDIES REGARDING PREVENTION OF CARDIOVASCULAR
DISEASE
INFORMATION ADDED TO THE LABELING THAT DETAILS INFORMATION RELATIVE TO STUDIES DONE IN
PEDIATRIC POPULATIONS IN THE CLINICAL PHARMACOLOGY AND PEDIATRIC USE SUBSECTIONS
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
FOR LABELING CHANGES BASED ON RESULTS OF THE SPD422-202 CLINICAL STUDY REPORT (CSR)
SUBMITTED IN RESPONSE TO THE WRITTEN REQUEST
ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED IN PEDIATRIC PATIENTS WITH
LEUKEMIA ADDED TO PRECAUTIONS
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"
ADDITION OF A GERIATRIC USE SUBSECTION TO THE PRECAUTIONS SECTION OF THE PACKAGE INSERT
AND GERIATRIC DOSING INFORMATION
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
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
INFORMATION ADDED TO CLINICAL TRIALS SECTION OF LABELING - EFFECTS OF HUMATROPE
TREATMENT IN ADULTS WITH GROWTH HORMONE DEFICIENCY
PROVISION OF RESULTS OF STUDY AND PROPOSED REVISIONS TO PACKAGE INSERT SEE SECTION ON
CARDIAC ELECTROPHYSIOLOGY
PROVIDES FOR USE OF ANTARA WITHOUT REGARD TO MEALS
CHANGES TO THE LABELING DESCRIBING THE RESULTS OF A STUDY OF THE USE OF NOVOLOG 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
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
INFORMATION ADDED TO LABELING REGARDING OSTEOGENESIS IMPERFECTA STUDY
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
FOR LABELING CHANGES TO THE QUALITY OF LIFE (QOL) STATEMENT IN THE APPROVED PACKAGE
INSERT
INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
INFORMATION ON RESULTS OF A STUDY OF THE USE OF SANDOSTATIN LAR DEPOT IN PEDIATRIC
PATIENTS WITH HYPOTHALAMIC OBESITY.
INFORMATION ADDED TO CLINICAL TRIAL SECTION WITH INFORMATION ON "GEMINI" TRIAL
CLINICAL DATA ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING THE PHARMACOKINETICS
OF EZETIMIBE IN ASIAN SUBJECTS
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
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
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
REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 22 of 51

EXCLUSIVITY MISCELLANEOUS
M-62

M-63
M-64
M-65
M-66
M-67
M-68
M-69
M-70
M-71
M-72
M-73
M-74
M-75
M-76

M-77

M-78
M-79
M-80
M-81

M-82
M-83
M-84
M-85
M-86

M-87
M-88
M-89
M-90
M-91

M-92

M-93

M-94
M-95

CLINICAL INFORMATION FROM ONE CLINICAL STUDY INVESTIGATING THE USE OF AVANDAMET PLUS
INSULIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE NOT ACHIEVED ADEQUATE
GLYCEMIC CONTROL WITH PREVIOUS ANTI-DIABETIC THERAPIES
DETAILED INFORMATION ON AN INCONCLUSIVE PEDIATRIC STUDY
CHANGES TO CLINICAL PHARMACOLOGY DETAILING STUDY RESULTS
ADDITION OF INFORMATION TO LABEL TO INCLUDE INFORMATION REGARDING USE IN PATIENTS 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
INDICATION EXPANDED TO INCLUDE PATIENTS ON PERITONEAL DIALYSIS
DESCRIPTION OF RESULTS OF STUDY OF INITIAL THERAPY IN COMBINATION WITH METFORMIN WHEN
DIET AND EXERCISE DO NOT PROVIDE GLYCEMIC CONTROL
RESULTS OF STUDY OF COMBINATION THERAPY AND NON-INFERIORITY STUDY
PROVISION OF INFORMATION OF THE RESULTS OF A PHASE 2 RANDOMIZED TRIAL OF SPRYCEL 70MG
TWICE DAILY OR IMATINIB 800MG DAILY
REVISIONS TO PROVIDE FOR RESULTS OF MAINTENANCE DATA IN ADULT PATIENTS WITH MAJOR
DEPRESSIVE DISORDER
INFORMATION ABOUT USE OF INSPRA (EPLERENONE) FOR HYPERTENSION IN PEDIATRIC PATIENTS
NEW INFORMATION ADDED REGARDING THE TUMOR SHRINKING POTENTIAL OF SANDOSTATIN LAR DEPOT
INJECTION ON GH - SECRETING PITUITARY ADENOMAS
REVISIONS TO CLINICAL STUDIES - CHILDREN AND ADOLSCENTS BASED ON CLINICAL TRIAL DATA TO
SUPPORT A DURATION OF ACTION CLAIM UP TO 12 HOURS
PROVISION FOR USE OF ARGAGATROBAN IN CERTAIN PEDIATRIC PATIENTS WITH HEPARIN-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
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
CLINICAL TRIAL INFO ON USE OF STRATTERA IN PATIENTS WITH ATTENTION DEFICIT HYPERACTIVITY
DISORDER (ADHD) AND COMORBID ANXIETY DISORDER WITHOUT CAUSING WORSENING OF ANXIETY
LABELING REVISIONS RELATED TO SMOKING AND ERLOTIMB EXPOSURE
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
ADDITIONAL INFORMATION ADDED TO LABELING REGARDING ESTABLISHMENT OF EFFICACY IN
ADDITIONAL CLINICAL TRIALS AND ONE MAINTENANCE TRIAL
STUDY INFORMATION ADDED TO LABEL REGARDING BONE MINERAL DENSITY
INFORMATION ADDED TO LABELING REGARDING USE OF PREVACID IN PATIENTS LESS THAN 1 YEAR
WITH SYMPTOMATIC GERD
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
INCLUSION OF RESULTS FROM TWO DRUG INTERACTION STUDIES WITH LIPITOR AND CRESTOR IN
CLINICAL PHARMACOLOGY SECTION
ADDITION OF INFORMATION REGARDING ABUSE POTENTIAL OF CONCERTA VERSUS IMMEDIATE-RELEASE
METHYLPHENIDATE
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
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
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
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
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
INFO ADDED TO LABEL RELATED TO NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME POSITIVE (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

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 23 of 51

EXCLUSIVITY MISCELLANEOUS
M-96

M-97
M-98
M-99

M-100
M-101
M-102

M-103

M-104
M-105

M-106
M-107

M-108

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
LABELING CHANGES IN RESPONSE TO PEDIATRIC STUDIES - NOT INDICATED FOR USE IN PEDIATRIC
POPULATION
NEW INFORMATION FROM A STUDY WHICH EVALUATED THE SAFETY AND EFFICACY OF FAMVIR IN
TREATING RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT BLACK/AFRICAN AMERICAN SUBJECTS.
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.
INFORMATION ADDED TO LABEL BASED UPON COMPLETED CLINICAL TRIAL REPORTS
INCLUSION OF DATA FROM AN ADDITIONAL 19 SUBJECTS WITH HYPERCALCEMIA FROM PARATHYROID
CARCINOMA TO THE INFORMATION CURRENTLY PRESENTED IN THE LABEL
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."
SAFETY, EFFICACY AND PHARMACOKINETIC INFO FOR FASLODEX IN THE PEDIATRIC POPULATION,
SPECIFICALLY FOR GIRLS WITH PROGRESSIVE PRECOCIOUS PUBERTY ASSOCIATED WITH MCCUNEALBRIGHT SYNDROME ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING
INFORMATION ADDED TO DOSING AND ADMINISTRATION REGARDING A 26 WEEK STUDY
NEW LANGUAGE ADDED TO CLINICAL STUDIES REGARDING USE IN SMOKERS WITH 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
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".
CHANGES ARE BASED ON RESULTS FROM STUDY CV181057

PATENT USE
U-1
U-2
U-3
U-4
U-5
U-6
U-7
U-8
U-9
U-10
U-11
U-12
U-13
U-14
U-15
U-16
U-17
U-18
U-19
U-20
U-21
U-22

U-23
U-24
U-25
U-26
U-27

PREVENTION OF PREGNANCY
TREATMENT OR PROPHYLAXIS OF ANGINA PECTORIS AND ARRHYTHMIA
TREATMENT OF HYPERTENSION
PROVIDING PREVENTION AND TREATMENT OF EMESIS AND NAUSEA IN MAMMALS
METHOD OF PRODUCING BRONCHODILATION
METHOD OF PRODUCING SYMPATHOMIMETIC EFFECTS
INCREASING CARDIAC CONTRACTILITY
ACUTE MYOCARDIAL INFARCTION
CONTROL OF EMESIS ASSOCIATED WITH ANY CANCER CHEMOTHERAPY AGENT
DIAGNOSTIC METHOD FOR DISTINGUISHING BETWEEN HYPOTHALMIC MALFUNCTIONS OR LESIONS IN
HUMANS
TREATMENT OR PROPHYLAXIS OF CARDIAC DISORDERS
METHOD OF TREATING [A] HUMAN SUFFERING FROM DEPRESSION
A METHOD FOR TREATING ANXIETY IN A HUMAN SUBJECT IN NEED OF SUCH TREATMENT
ADJUNCTIVE THERAPY FOR THE PREVENTION AND TREATMENT OF HYPERAMMONEMIA IN THE CHRONIC
MANAGEMENT OF PATIENTS WITH UREA CYCLE ENZYMOPATHIES
METHOD OF LOWERING INTRAOCULAR PRESSURE
USE IN LUNG SCANNING PROCEDURES
TREATMENT OF VENTRICULAR AND SUPRAVENTRICULAR ARRHYTHMIAS
METHOD FOR INHIBITING GASTRIC SECRETION IN MAMMALS
TREATMENT OF INFLAMMATION
A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF
TREATMENT
TREATMENT OF HUMANS SUFFERING UNDESIRED UROTOXIC SIDE EFFECTS CAUSED BY CYTOSTATICALLY
ACTIVE ALKYLATING AGENTS
METHOD OF COMBATTING PATHOLOGICALLY REDUCED CEREBRAL FUNCTIONS AND PERFORMANCE
WEAKNESSES, CEREBRAL INSUFFICIENCY AND DISORDERS IN CEREBRAL CIRCULATION AND METABOLISM
IN WARM-BLOODED ANIMALS
METHOD FOR TREATING PROSTATIC CARCINOMA COMPRISING ADMINISTERING FLUTAMIDE
METHOD FOR TREATING PROSTATE ADENOCARCINOMA COMPRISING ADMINISTERING AN ANTIANDROGEN
INCLUDING FLUTAMIDE AND AN LHRH AGONIST
REDUCING CHOLESTEROL IN CHOLELITHIASIS PATIENTS
REDUCING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF
DISSOLVING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF

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PATENT AND EXCLUSIVITY TERMS

ADB 24 of 51

PATENT USE
U-28
U-29
U-30
U-31
U-32
U-33
U-34
U-35
U-36
U-37
U-38
U-39
U-40
U-41
U-42
U-43
U-44
U-45
U-46
U-47
U-48
U-49
U-50
U-51
U-52
U-53
U-54
U-55
U-56
U-57
U-58
U-59
U-60
U-61
U-62
U-63
U-64
U-65
U-66
U-67
U-68
U-69
U-70
U-71
U-72
U-73
U-74
U-75
U-76
U-77
U-78
U-79
U-80
U-81
U-82
U-83

CEREBRAL, CORONARY, PERIPHERAL, VISCERAL AND RENAL ARTERIOGRAPHY, AORTOGRAPHY AND LEFT
VENTRICULOGRAPHY
CT IMAGING OF THE HEAD AND BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY
CEREBRAL ANGIOGRAPHY, AND VENOGRAPHY
INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY
PALLIATIVE TREATMENT OF PATIENTS WITH OVARIAN CARCINOMA RECURRENT AFTER PRIOR
CHEMOTHERAPY, INCLUDING PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED WITH CISPLATIN
TREATING VIRAL INFECTIONS IN A MAMMAL
TREATING VIRAL INFECTIONS IN A WARM-BLOODED ANIMAL
TREATING CYTOMEGALOVIRUS IN A HUMAN WITH AN INJECTABLE COMPOSITION
METHODS OF TREATING BACTERIAL ILLNESSES
METHOD OF TREATING GASTROINTESTINAL DISEASE
TREATMENT OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA
ANGINA PECTORIS
METHOD OF TREATMENT OF BURNS
METHOD OF TREATING CARDIAC ARRHYTHMIAS
ADJUVANT TREATMENT IN COMBINATION WITH FLUOROURACIL AFTER SURGICAL RESECTION IN PATIENTS
WITH DUKES' STAGE C COLON CANCER
MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
RELIEF OF NAUSEA AND VOMITING
TREATMENT OF INFLAMMATION AND ANALGESIA
TREATMENT OF PANIC DISORDER
STIMULATION OF THE RELEASE OF GROWTH HORMONE
ANALGESIA
SYMPTOMATIC CANCER-RELATED HYPERCALCEMIA
USE IN TREATING INFLAMMATORY DERMATOSES
BLOOD POOL IMAGING, INCLUDING CARDIAC FIRST PASS AND GATED EQUILIBRIUM IMAGING AND FOR
DETECTION OF SITES OF GASTROINTESTINAL BLEEDING
TREATMENT OF ADULT AND PEDIATRIC PATIENTS(OVER SIX MONTHS OF AGE) WITH ADVANCED HIV
INFECTION
HYPERCALCEMIA OF MALIGNANCY
REVERSAL AGENT OR ANTAGONIST OF NONDEPOLARIZING NEUROMUSCULAR BLOCKING AGENTS
TREATMENT OF PAIN
AID TO SMOKING CESSATION
OPHTHALMIC USE OF NORFLOXACIN
METHOD OF TREATING INFLAMMATORY INTESTINAL DISEASES
METHOD OF TREATING HYPERCHOLESTEROLEMIA
NASAL ADMINISTRATION OF BUTORPHANOL
CEREBRAL AND PERIPHERAL ARTERIOGRAPHY AND CT IMAGING OF THE HEAD
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
TREATMENT OF VIRAL INFECTIONS
METHOD OF TREATMENT OF A PATIENT INFECTED WITH HIV
TRIPHASIC REGIMEN
METHOD OF INDUCING ANESTHESIA IN A WARM BLOODED ANIMAL
TREATMENT OF ACTINIC KERATOSIS
TREATMENT OF PNEUMOCYSTIS CARINII INFECTIONS
TREATMENT OF TRANSIENT INSOMNIA
METHOD OF TREATMENT OF HEART FAILURE
TREATMENT OF MIGRAINE
METHOD OF TREATING DISEASES OR INFECTIONS CAUSED BY MYCETES
METHOD OF PROVIDING HYPNOTIC EFFECT
RELIEF OF OCULAR ITCHING DUE TO SEASONAL ALLERGIC CONJUNCTIVITIS
USE TO IMAGE A SUBJECT WITH A MAGNETIC RESONANCE IMAGING SYSTEM
TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
ULCERATIVE COLITIS
SYMPTOMATIC TREATMENT OF PATIENTS WITH NOCTURNAL HEARTBURNDUE TO GERD
METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS
TREATMENT FOR DEMENTIA IN PATIENTS WITH ALZHEIMER'S DISEASE
TREATMENT OF SEIZURES

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 25 of 51

PATENT USE
U-84
U-85
U-86
U-87
U-88
U-89
U-90
U-91
U-92
U-93
U-94

U-95
U-96
U-97
U-98
U-99
U-100
U-101
U-102
U-103
U-104
U-105
U-106
U-107
U-108

U-109

U-110
U-111
U-112
U-113
U-114
U-115
U-116
U-117
U-118
U-119
U-120
U-121
U-122
U-123
U-124
U-125
U-126
U-127
U-128
U-129
U-130
U-131
U-132

A METHOD OF BLOCKING THE UPTAKE OF MONOAMINES BY BRAIN NEURONS IN ANIMALS

NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
METHOD OF TREATING CERTAIN FORMS OF EPILEPSY
METHOD FOR NONINVASIVE ADMINISTRATION OF SEDATIVES, ANALGESICS, AND ANESTHETICS
TREATMENT OF MODERATE PLAQUE PSORIASIS
TREATMENT OR PROPHYLAXIS OF EMESIS
TREATMENT OF PYSCHOTIC DISORDERS
ALTERNATIVE THERAPY TO TRIMETHOPRIM-SULFAMETHOXAZOLE FOR TREATMENT OF MODERATE-TO-SEVERE
PNEUMOCYSTIS CARINII PNEUMONIA IN IMMUNOCOMPROMISED AND AIDS PATIENTS
TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN DEPENDENT DIABETES
MELLITUS AND RETINOPATY
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
SHORT TERM MANAGEMENT OF MODERATE PRURITIS IN ADULTS WITH ATOPIC DERMATITIS AND LICHEN
SIMPLEX CHRONICUS
METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS
A METHOD OF TREATING A PATIENT IN NEED OF MEMORY ENHANCEMENT
A METHOD OF INDUCING REGRESSION OF LEUKEMIA CELL GROWTH IN A MAMMAL
METHOD OF PROVIDING POTASSIUM TO A SUBJECT IN NEED OF POTASSIUM
METHOD OF TREATING OCULAR INFLAMMATION
ADJUNCT TO CONVENTIONAL CT OR MRI IMAGING IN THE LOCALIZATION OF STROKE IN PATIENTS IN
WHOM STROKE HAS ALREADY BEEN DIAGNOSED
METHOD OF HORMONALLY TREATING MENOPAUSAL OR POST-MENOPAUSAL DISORDERS IN WOMEN
TREATMENT OF OCULAR HYPERTENSION
TREATMENT OF AQUEOUS HUMOR FORMATION AND INTRAOCULAR PRESSURE
EMESIS
TREATMENT OF EPILEPSY
TREATMENT OF HYPERTENSION AND ANGINA PECTORIS
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 ESOPHAGITIS
ADJUNCT DIET IN THE TX OF ELEVATED TOTAL CHOLESTEROL AND LDL-C LEVELS IN PTS 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
DIABETES
CONTRACEPTION
METHOD OF CONDUCTING RADIOLOGICAL EXAMINATION OF A PATIENT BY ADMINISTERING TO SAID
PATIENT A RADIOPAQUE AMOUNT OF IOPROMIDE
USE FOR INHIBITING BONE RESORPTION
USE OF VASODILATORS TO EFFECT AND ENHANCE AN ERECTION (AND THUS TREAT ERECTILE
DYSFUNCTION), BY INJECTION INTO THE PENIS
METHOD OF MYOCARDIAL IMAGING
TREATMENT OF OCULAR ALLERGIC RESPONSE IN HUMAN EYES
METHOD OF LOWERING BLOOD SUGAR LEVEL
TREATMENT OF NASAL HYPERSECRETION
CONTROLLING OR PREVENTING POST-OPERATIVE INTRAOCULAR PRESSURE RISES ASSOCIATED WITH
OPHTHALMIC LASER SURGICAL PROCEDURES
METHOD OF TREATING CONDITIONS MEDIATED THROUGH HISTAMINE H2-RECEPTORS
A THERAPEUTIC METHOD FOR CONTROLLING THROMBOSIS
METHOD FOR CONTROLLING THROMBOSIS AND DECREASING BLOOD HYPERCOAGULATION AND HEMORRHAGING
RISKS
TREATMENT OF ACNE
TREATMENT NEUROGENERATIVE DISEASES
TREATMENT OF GASTRITIS
METHOD OF PRODUCING NEUROMUSCULAR BLOCKADE
METHOD FOR TREATMENT OF TUMORS
METHOD TO DESTROY OR IMPAIR TARGET CELLS
MANAGEMENT OF PATIENTS WITH MASTOCYTOSIS
PHOTODAMAGED SKIN
INHIBITING HIV PROTEASE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 26 of 51

PATENT USE
U-133
U-134
U-135
U-136
U-137
U-138
U-139
U-140
U-141
U-142
U-143
U-144
U-145
U-146
U-147
U-148
U-149
U-150
U-151
U-152
U-153
U-154
U-155
U-156
U-157
U-158
U-159
U-160
U-161
U-162
U-163
U-164
U-165
U-166
U-167
U-168
U-169
U-170
U-171
U-172
U-173
U-174
U-175
U-176
U-177
U-178
U-179
U-180
U-181
U-182
U-183

MANAGEMENT OF OBESITY INCLUDING WEIGHT LOSS AND MAINTENANCE IN PATIENTS ON A REDUCEDCALORIE DIET
TREATMENT OF ACNE VULGARIS
ANTITUMOR AGENT
PROCESS FOR WASTE NITROGEN REMOVAL
METHOD OF TREATING BACTERIAL VAGINOSIS
TREATMENT OF ALLERGIC RHINITIS
TREATMENT OF ALLERGIC REACTIONS
USE OF NORVIR TO INHIBIT HIV PROTEASE OR TO INHIBIT AN HIV INFECTION
TREATMENT OF ULCERATIVE COLITIS
METHOD OF TREATING ALLERGIC REACTIONS IN A MAMMAL BY USING THIS ACTIVE METABOLITE
BIODEGRADABLE SUPERPARAMAGNETIC METAL OXIDES AS CONTRAST AGENTS FOR MR IMAGING
BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC MATERIALS FOR USE IN CLINICAL APPLICATIONS
BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC PARTICLES FOR USE AS NUCLEAR MAGNETIC
RESONANCE IMAGING AGENTS
METHOD OF TREATING SUSCEPTIBLE NEOPLASMS IN MAMMALS
DETECTION OF GASTROINTESTINAL DISORDERS AND THE SUBSEQUENT BREATH COLLECTION AND
MEASUREMENT OF 13CO2
DEVICE FOR COLLECTING A BREATH SAMPLE
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
RELIEF OF SYMPTOMS OF THE COMMON COLD
METHOD OF TREATING ANXIETY RELATED DISORDERS INCLUDING OBSESSIVE COMPULSIVE DISORDER
TREATMENT OF INITIAL EPISODE GENITAL HERPES
METHOD OF TREATING ANIMALS SUFFERING FROM AN APPETITE DISORDER
TREATMENT OF ERECTILE DYSFUNCTION
METHOD OF PROVIDING ANESTHESIA
TREATMENT OF A HUMAN SUFFERING FROM VITAMIN B12 DEFICIENCY
ANGINA
TREATMENT OF INTERSTITIAL CYSTITIS
TREATMENT OF BACTERIAL INFECTIOUS DISEASE
METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS IN A PATIENT
METHOD OF USE TO INHIBIT CHOLESTEROL SYNTHESIS IN A HUMAN SUFFERING FROM
HYPERCHOLESTEROLEMIA
METHOD OF USING TROGLITAZONE TO TREAT IMPAIRED GLUCOSE TOLERANCE TO PREVENT OR DELAY THE
ONSET OF NONINSULIN-DEPENDENT DIABETES MELLITUS
METHOD OF USING TROGLITAZONE TO PREVENT OR DELAY THE ONSET OF NONINSULIN-DEPENDENT
DIABETES MELLITUS IN A DEFINED POPULATION OF PATIENTS
TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
TREATMENT OF H.PYLORI-ASSOCIATED DUODENAL ULCER
METHOD FOR TREATING HIV-1 INFECTION
METHOD OF INHIBITING LIPOXYGENASE ACTIVITY IN A MAMMAL WHICH IS THE MODE OF ACTION IN
THE TREATMENT OF ASTHMA
METHODS OF USING THE COMPOUND/DRUG PRODUCT AS A CONTRAST AGENT IN MAGNETIC RESONANCE
IMAGING
METHOD OF OBTAINING AN MR IMAGE USING THE COMPOSITION/DRUG PRODUCT AS A CONTRAST AGENT
METHODS OF USING THE COMPOUND/DRUG PRODUCT AS AN ORAL CONTRAST AGENT IN MAGNETIC
RESONANCE IMAGING OF THE GASTROINTESTINAL TRACT
TREATMENT OF GENITAL WARTS
ADMINISTRATION TO A HOST SUFFERING FROM GESTATIONAL DIABETES
USE AS AN ANTIHISTAMINE AGENT
METHOD OF TREATING MALIGNANT TUMORS
METHOD OF TREATING A PATIENT SUFFERING FROM LISTED CONDITIONS, INCLUDING SPECIFIC
PSYCHOSES
FUNGICIDE
FACILITATED ADHERENCE OF AGENTS TO SKIN
ENHANCED CUTANEOUS PENETRATION OF A DERMALLY-APPLIED PHARMACOLOGICALLY ACTIVE AGENT
TREATMENT OF ADULT AND PEDIATRIC PATIENTS (OVER 6 MONTHS OF AGE) WITH ADVANCED HIV
INFECTION
PRODUCING ALPHA ADRENERGIC ANTAGONISTIC ACTION IN A HOST
USE OF SALMETEROL IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION
TREATMENT OF CONDITIONS CAUSED BY DISTURBANCE OF NEURONAL 5HT FUNCTION

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 27 of 51

PATENT USE
U-184
U-185
U-186
U-187
U-188
U-189
U-190
U-191
U-192
U-193
U-194
U-195
U-196
U-197
U-198

U-199
U-200
U-201
U-202
U-203
U-204
U-205
U-206
U-207
U-208
U-209
U-210
U-211
U-212
U-213
U-214
U-215
U-216
U-217
U-218
U-219
U-220
U-221
U-222
U-223
U-224
U-225
U-226
U-227
U-228
U-229
U-230
U-231

TREATING ALLERGIC EYE DISEASES IN HUMANS

METHOD OF TREATING HYPERTENSION
METHOD FOR TREATING GI DISORDERS CAUSED BY H.RYLORI WHICH COMPRISES ADMINISTRATION OF
RANITIDINE BISMUTH CITRATE AND CLARITHROMYCIN FOR A GREATER THAN ADDITIVE EFFECT
THERAPEUTIC TREATMENT OF CALCIFIC TUMORS
TREATMENT OF H.PYLORI ASSOCIATED DUODENAL ULCER
ENHANCEMENT OF THE BIOAVAILABILITY OF THE DRUG SUBSTANCE
USE OF RITONAVIR IN COMBINATION WITH ANY REVERSE TRANSCRIPTASE INHIBITOR
METHOD OF TREATMENT FOR CONTROLLING AND LOWERING INTRAOCULAR PRESSURE IN A HUMAN
USE IN TREATING ALLERGIC REACTIONS
PSORIASIS
TREATING ANGINA PECTORIS AND HIGH BLOOD PRESSURE
METHOD FOR THE DIAGNOSIS OF GASTROINTESTINAL DISORDERS BY UREA ISOTOAC OR NITROGEN
LABELED CARBON
TREATMENT OF METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR
POSITIVE TUMORS
USE IN COMBINATION WITH CERTAIN LHRH ANALOGUES FOR THE TREATMENT OF ADVANCED PROSTATE
CANCER
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
METHOD OF TREATING INFECTIOUS UPPER GI TRACT DISORDERS CAUSED BY CAMPYLOBACTER PYLORIDIS
INFECTION COMPRISING ADMINISTRATION OF A BISMUTH AGENT AND AN ANTIMICROBIAL AGENT
METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF A BISMUTH-CONTAINING AGENT
AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT
METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF CAMPYLOBACTER-INHIBITING
ANTIMICROBIAL AGENT AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT
METHOD OF TREATING PEPTIC ULCER DISEASE CAUSED BY CAMPYLOBACTER PYLORIDIS COMPRISING
ORAL ADMINISTRATION OF 50 TO 5,000MG BISMUTH DAILY FOR 3-56 DAYS
TREATMENT OF ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH DISEASE PROGRESSION
FOLLOWING ANTIESTROGEN THERAPY
USE OF TAXOL IN COMBINATION WITH G-CSF FOR TREATMENT OF PATIENTS WITH AIDS-RELATED
KAPOSI'S SARCOMA
METHOD FOR TREATING HEARTBURN
METHOD OF USING FSH ALONE, WITHOUT THE PRESENCE OF EXOGENEOUS LH, IN IN VITRO
FERTILIZATION
USE AS NASAL SPRAY
VAGINAL ADMINISTRATION USING SPECIFIED FORMULATION
VAGINAL ADMINISTRATION OF PROGESTERONE USING SPECIFIED FORMULATION
METHOD OF TREATING CONGESTIVE HEART FAILURE
USE IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION
METHOD OF TREATMENT OF PARKINSON'S DISEASE
METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS AND TREATING HYPERCHOLESTEROLEMIA AND
METHOD FOR TREATING HYPERLIPIDEMIA
USE AS A BLOOD GLUCOSE-LOWERING AGENT
TREATMENT OF EPILEPSY TWICE DAILY. TREATING A PATIENT BY ADMINISTERING CARBAMAZEPINE IN
A DOSAGE FORM CAPABLE OF MAINTAINING BLOOD CONCENTRATION FROM 4-12MCG/ML OVER 12 HOURS
TREATMENT OF ADENOCARCINOMA, INCLUDING STAGE B2-C BY ADMINISTERING AN AGONIST OF LH-RH
AND FLUTAMIDE
METHOD OF PRODUCING ANESTHESIA
METHOD FOR LIMITING THE POTENTIAL FOR MICROBIAL GROWTH IN THE DRUG PRODUCT
TREATMENT OF PARKINSON'S DISEASE
METHOD OF DIAGNOSIS
SELECTIVE VASODILATION BY CONTINUOUS ADENOSINE INFUSION
METHOD OF TREATING PAGET'S DISEASE USING ACTONEL
TREATMENT OF BACTERIAL CONJUNCTIVITIS CAUSED BY SUSCEPTIBLE STRAINS OF MICROORGANISMS
CONTROLLING INTRAOCULAR PRESSURE
MEHTOD FOR DELIVERY
METHOD OF ENHANCING THE DISSOLUTION PROFILE OF A PHARMACEUTICAL FROM A SOLID DOSAGE FORM
CONTAINING THE PHARMACEUTICAL AND SIMETHICONE
NASAL ADMINISTRATION
ASTHMA
CARDIAC INSUFFICIENCY (CONGESTIVE HEART FAILURE)
PREVENTION OF ACUTE CARDIAC ISCHEMIC EVENTS
USE IN PARKINSON'S DISEASE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 28 of 51

PATENT USE
U-232
U-233
U-234
U-235

U-236
U-237
U-238

U-239

U-240
U-241

U-242
U-243
U-244
U-245
U-246
U-247
U-248
U-249
U-250
U-251
U-252
U-253
U-254
U-255
U-256
U-257
U-258
U-259
U-260

U-261
U-262
U-263

U-264

U-265
U-266

U-267

U-268
U-269
U-270
U-271
U-272
U-273

METHOD OF TREATING MIGRAINE

DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE
METHOD OF USING RIBAVIRIN TO TREAT VIRAL INFECTIONS IN MAMMALS
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
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
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
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
TREATMENT OF ACUTE MIGRAINE ATTACKS
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
USE OF FOLLITROPIN ALPHA ALONE IN IN-VITRO FERTILIZATION
TOPICAL ADMINISTRATION
PLATELET AGGREGATION INHIBITORS
TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
PHOSPHATE BINDING
TREATMENT OF RHEUMATOID ARTHRITIS
TREATMENT OF HIV
METHOD OF TREATING ALLERGIC OR NON-ALLERGIC RHINITIS IN PATIENTS BY ADMINISTERING
AEROSOLIZED PARTICLES OF MOMETASONE FUROATE
TREATMENT OF HEPATITIS B INFECTION
USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS IN THE TREATMENT OF TYPE II
DIABETES
METHOD OF TREATING A HUMAN SUBJECT HAVING GAUCHER'S DISEASE
ORAL TRANSMUCOSAL USE
USE OF AGGRASTAT IN COMBINATION WITH HEPARIN
IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH
NARCOLEPSY
TREATMENT OF HIV INFECTION IN COMBINATION WITH ONE OR MORE ADDITIONAL HIV ANTIVIRAL
AGENTS
TREATMENT OF HIV INFECTION
TREATMENT OF NEURODEGENERATIVE DISEASES
TREATMENT OF ANDROGENIC ALOPECIA BY ORAL ADMINISTRATION DRUG SUBSTANCE
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
TREATING BENIGN PROSTATIC HYPERPLASIA WITH A GENUS OF COMPOUNDS, INCLUDING FINASTERIDE
TREATING BENIGN PROSTATIC HYPERTROPHY WITH FINASTERIDE
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
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
USE AS LAXATIVE
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 FOOD/BEVERAGE,
COMPRISING ADMIN TO PT, 30 MIN PRIOR TO CONSUMPTION BY THE PT THE FOOD/BEVERAGE, A
COMPOSITION COMPRISING 10MG FAMOTIDINE
ACROMEGALY
EXCESS GH-SECRETION OR GASTRO-INTESTINAL DISORDERS
METHOD OF IMPROVING THE TIME FOR ADMINISTRATION OR THE TIME BETWEEN CHANGES OF GIVING
SETS FOR THE DRUG PRODUCT
METHOD OF TREATING TUMORS
METHOD OF TREATING CARCINOMA
CUTANEOUS T-CELL LYMPHOMA

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 29 of 51

PATENT USE
U-274
U-275
U-276
U-277
U-278
U-279
U-280
U-281
U-282
U-283
U-284
U-285
U-286
U-287
U-288
U-289
U-290
U-291
U-292
U-293
U-294
U-295
U-296

U-297
U-298
U-299
U-300
U-301
U-302
U-303
U-304
U-305
U-306
U-307
U-308

U-309
U-310
U-311
U-312
U-313
U-314
U-315
U-316
U-317
U-318
U-319
U-320
U-321

ZANAMIVIR FOR INHALATION

METHOD OF USE OF THE DRUG SUBSTANCE
METHOD OF USE OF LEVOBUPIVACAINE
NEUROLOGICAL AND OTHER DISORDERS (TREATMENT OF EPILEPSY, BID ORAL DOSING)
METHOD OF USE OF THE INDICATION OF THE DRUG PRODUCT
METHOD OF USE OF THE APPROVED PRODUCT
TREATING PRECIPITATED ACUTE URINARY RETENTION WITH FINASTERIDE
ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS
METHOD OF TREATING BACTERIAL INFECTIONS
METHOD FOR TREATING MENOPAUSAL SYMPTOMS IN A POSTMENOPAUSAL FEMALE
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
TREATMENT OR PREVENTION OF OSTEOPOROSIS
THERAPY OF INFLUENZA
TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS)
INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH
CYCLOSPORIN
INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH
AZATHIOPRINE
INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH A
CORTICOSTEROID
TREATMENT OF HYPERPIGMENTARY DISORDERS
TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
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
PREVENTION OR TREATMENT OF REVERSIBLE VASOCONSTRICTION BY THE INHALATION OF NITRIC OXIDE
WITH AN OXYGEN CONTAINING GAS
METHOD OF COMBATING BACTERIA IN A PATIENT
TREATMENT OF ADENOMATOUS POLYPS
INDICATED FOR THE REDUCTION OF ELEVATED TOTAL AND LDL CHOLESTEROL LEVELS IN PATIENTS
WITH PRIMARY HYPERCHOLESTEROLEMIA
USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS AND BIGUANIDES IN THE TREATMENT OF
TYPE II DIABETES
TO REDUCE THE RISK OF STROKE IN PATIENTS WHO HAVE HAD TRANSIENT ISCHEMIA OF THE BRAIN OR
COMPLETED ISCHEMIC STROKE DUE TO THROMBOSIS
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
METHODS FOR USING THE DRUG PRODUCT
TREATMENT OF POST-MENOPAUSAL UROGENITAL SYMPTOMS ASSOCIATED WITH ESTROGEN DEFICIENCY
CLAIMS AN OLANZAPINE POLYMORPH USEFUL FOR TREATING ANY NUMBER OF LISTED CONDITIONS,
INCLUDING SPECIFIC PSYCHOSES,EMPLOYING OLANZAPINE AS PER THE INDICATION OF THIS NDA
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
TREATING SJOEGREN SYNDROME
TREATMENT OF XEROSTOMIA
HORMONE REPLACEMENT
PANIC DISORDER, OBSESSIVE-COMPULSIVE DISORDER, POSTTRAUMATIC STRESS DISORDER
TREATMENT OF CONGESTIVE HEART FAILURE
METHOD FOR TREATING HYPERPARATHYROIDISM WHICH COMPRISES SUPPRESSING PARATHYROID ACTIVITY
METHOD FOR ADMINISTERING DRUG TO GASTROINTESTINAL TRACT
METHOD OF TREATING A SUBJECT SUFFERING FROM PROSTATE CANCER
METHOD OF USING TROGLITAZONE TO TREAT PATIENTS HAVING INSULIN RESISTANCE
TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY,
URGENCY, OR URGE INCONTINENCE
TREATMENT OF MICROBIAL INFECTIONS
INHIBITING OR ELIMINATING ACUTE MYELOID LEUKEMIA
REDUCTION OF ELEVATED IPTH LEVELS IN THE MGT OF SECONDARY HYPERPARATHYROIDISM IN
PATIENTS UNDERGONG CHRONIC RENAL DIALYSIS

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 30 of 51

PATENT USE
U-322
U-323
U-324
U-325
U-326
U-327
U-328
U-329
U-330
U-331
U-332
U-333
U-334
U-335
U-336
U-337
U-338
U-339
U-340
U-341
U-342
U-343
U-344
U-345
U-346

U-347
U-348
U-349
U-350
U-351
U-352
U-353
U-354

U-355
U-356
U-357

U-358
U-359
U-360

U-361
U-362
U-363

TREATMENT OF ALZHEIMER'S DEMENTIA

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
METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS,
INCLUDING "BIPOLAR DISORDER NOS" EMPLOYING OLANZAPINE
METHOD OF TREATING SCHIZOPHRENIA AND BIPOLAR DISORDER
METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED PSYCHOTIC
CONDITONS EMPLOYING OLANZAPINE
METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS
INCLUDING "A PSYCHOTIC CONDITION" EMPLOYING AN OLANZAPINE POLYMORPH
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
TREATMENT OF NAUSEA AND VOMITING
METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE
EVENING OR AT NIGHT
TREATMENT OR PREVENTION OF BRONCHOSPASM
METHOD OF TREATING OCULAR HYPERTENSION
TREATMENT OF EXCESSIVE FEMALE FACIAL HAIR
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
DIAGNOSTIC RADIOIMAGING
USE OF CARDIOLITE/MIRALUMA KIT FOR THE PREPARATION OF TC99M SESTAMIBI
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
THE LONG TERM TREATMENT OF GROWTH FAILURE DUE TO LACK OF ADEQUATE ENDOGENOUS GROWTH
HORMONE SECRETION IN CHILDREN
METHOD FOR ENHANCING THE TREATMENT OF ... LATE LUTEAL PHASE DYSPHORIC DISORDER
METHOD FOR TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER
REDUCTION OF INTESTINAL GAS, CRAMPING AND ANORECTAL IRRITATION
METHOD FOR INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH
ANOTHER HIV PROTEASE INHIBITOR
RITONAVIR AND ANOTHER HIV PROTEASE INHIBITOR FOR CONCOMITANT ADMINISTRATION FOR THE
TREATMENT OF AN HIV INFECTION
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
METHOD OF USE IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS
METHOD OF USE FOR INHIBITING HIV INFECTION
METHOD OF USE WHICH IS SUBJECT OF THE APPLICATION
PREPARATION OF A PHARMACEUTICAL COMPOSITION FOR CONCOMITANT ADMIN WITH A REVERSE
TRANSCRIPTASE INHIBITOR
INHIBITING PROTEASE WITH LOPINAVIR AND INHIBITING AN HIV INFECTION WITH LOPINAVIIR
INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH A REVERSE
TRANSCRIPTASE INHIBITOR
PREVENTION AND TREATMENT OF OSTEOPOROSIS
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
METHOD OF ASSISTING PERSON TO QUIT SMOKING...TRANSDERMALLY ADMIN NICOTINE VIA..PATCH
ADHERED TO SKIN AT DOSING RATE APPROX SAME AS ABSORBED FROM SMOKING
DELIVERING A MEDICINAL AEROSOL FORMULATION USING CFC-FREE PROPELLANT 134A.
USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF AGERELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED NEOVASCULATURE IN
THE EYE
DEPRESSION, OBSESSIVE COMPULSIVE DISORDER, PANIC DISORDER AND SOCIAL ANXIETY DISORDER
METHOD OF USE OF VISICOL
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
MANAGEMENT OF ANXIETY DISORDERS AND THE SHORT-TERM RELIEF OF THE SYMPTOMS OF ANXIETY
USE OF APPROVED FORMULATIONS TO TREAT ALL APPROVED DISEASE INDICATIONS
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

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 31 of 51

PATENT USE
U-364

U-365
U-366
U-367
U-368
U-369
U-370
U-371
U-372
U-373

U-374

U-375
U-376
U-377

U-378
U-379
U-380
U-381
U-382
U-383
U-384
U-385
U-386
U-387
U-388
U-389
U-390
U-391
U-392
U-393
U-394
U-395
U-396
U-397
U-398
U-399
U-400

U-401
U-402
U-403
U-404
U-405
U-406
U-407

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
METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A
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
TREATMENT OF CARDIOVASCULAR DISORDERS
HEARTBURN
METHOD OF CONTROLLING AND LOWERING INTRAOCULAR PRESSURE
INTRAVAGINAL TREATMENT OF VAGINAL INFECTIONS WITH BUFFERED METRONIDAZOLE COMPOSITIONS
APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA 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...
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
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
METHOD OF USING RIBAVIRIN FOR TREATING A DISEASE RESPONSIVE TO RIBAVIRIN, E.G. HEPATITIS
C
TREATMENT OF INFLUENZA
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
METHOD FOR TREATING INCONTINENCE
METHOD OF TREATING ONYCHROMYCOSIS
COMBINATIONS OF TAXOL (PACLITAXEL) AND CISPLATIN WHICH ARE SUITABLE FOR THE TREATMENT OF
OVARIAN AND NON-SMALL CELL LUNG CARCINOMAS
TREATMENT OF HYPERPHOSPHATEMIA
METHOD OF STABLIZING PROSTAGLANDIN
METHOD FOR TREATING GLAUCOMA AND OCULAR HYPERTENSION
TREATMENT OF CMV RETINITIS
TREATMENT OF PEPTIC ULCERS
TREATMENT OF PATIENTS SUFFERING FROM A LATE ASTHMATIC REACTION OR LATE PHASE ASTHMA
TREATMENT OF PATIENTS WITH RESPIRATORY DISORDERS
SMOKING CESSATION AID APPLIED TO THE SKIN
SMOKING CESSATION AID APPLIED TO THE SKIN ON WAKING AND REMOVED PRIOR TO SLEEP AFTER
ABOUT 16 HOURS
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
TREATMENT OF PATIENTS FOR INFLAMMATION
MANAGEMENT OF INCONTINENCE, MGT OF HORMONE REPLACEMENT THERAPY, TREATMENT OF INVOLUNTARY
INCONTINENCE, MGT OVERACTIVE BLADDER AND INCREASING COMPLIANCE IN SUCH PT
METHOD OF USE OF ALPHAGAN
METHOD OF USE OF ALPHAGAN P
METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION
METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION WITHOUT AN INCREASE IN NAUSEA
TREATMENT OF GENERALIZED ANXIETY DISORDER
IN-THE-EYE USE OF CHLORINE DIOXIDE CONTAINING COMPOSITIONS
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
USE OF LOPINAVIR IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS FOR TREATING HIV
INFECTION AND IN COMBO WITH OTHER HIV PROTEASE INHIBITORS
TREATMENT OF ACTINIC KERATOSES
ANTI-ALLERGIC FOR VARIOUS ALLERGIC DISEASES
TREATMENT OF ALLERGIC CONJUNCTIVITIS
FOR WOMEN WITH SEVERE DIARRHEA-PREDOMINANT IRRITABLE BOWEL SYNDROME (IBS)
METHOD OF USE OF ATOVAQUONE AND PROGUANIL
METHOD OF TREATING OTOPATHY

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 32 of 51

PATENT USE
U-408
U-409
U-410

U-411

U-412
U-413
U-414
U-415

U-416

U-417
U-418

U-419
U-420
U-421
U-422
U-423
U-424
U-425

U-426
U-427
U-428
U-429
U-430

U-431
U-432

U-433
U-434
U-435
U-436
U-437
U-438
U-439
U-440
U-441
U-442
U-443
U-444
U-445
U-446

FOR INDUCING OVULATION IN CONJUNCTION WITH A GONADOTROPIN RELEASING FACTOR ANTAGONIST

AND RECRUITING OOCYTES FOR IN-VITRO FERTILIZATION
METHOD OF TREATING INFLAMMATION USING DRUG SUBSTANCE
METHOD OF REDUCING AMOUNT OF RESPECTIVE ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA (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 (WHICH INCLUDES
PIOGLITAZONE) IN COMBINATION WITH AN INSULIN PREPARATION
TREATMENT OF TYPE 2 DIABETES
USE OF THE ACTIVE INGREDIENT FOR INHIBITING THE BIOSYNTHESIS OF CHOLESTEROL AND
TREATMENT OF ATHEROSCLEROSIS
A METHOD OF TREATING GLYCOMETABOLISM DISORDERS BY ADMINISTERING AN INSULIN 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
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
COMBINATION USE OF AD-4833 WITH A BIGUANIDE
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
A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING AN INSULIN SENSITIVITY
ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE
METHOD OF TREATMENT OF TYPE II DIABETES
USE FOR SEDATION
METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER AND ATTENTION DEFICIT
HYPERACTIVITY DISORDER
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
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
PREVENTION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION
METHOD OF TREATING ALLERGIC REACTIONS IN MAMMALS
METHOD OF TREATING ALLERGY IN A MAMMAL USING THIS ACTIVE METABOLITE
METHOD OF USING DESLORATADINE TO TREAT ALLERGIC RHINITIS
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
POSTTRAUMATIC STRESS DISORDER
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
USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH
END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
CONTROLLED SYMPTOMS OF DIARRHEA, BLOATING PRESSURE AND CRAMPS, COMMONLY REFERRED TO AS
GAS
A TITRATION DOSING REGIMEN FOR THE TREATMENT OF PAIN USING AN INITIAL DOSE OF ABOUT 25MG
ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
METHOD OF USE EQUAL TO PROCESS OF PREPARATION
TREATMENT/PREVENTION OF NEURODEGENERATIVE DISEASE
TREATMENT OF OBESITY
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
METHOD OF TREATING MS BY ADMINISTERING COPAXONE
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
MANAGEMENT OF MODERATE TO SEVERE PAIN WHEN A CONTINUOUS, AROUND-THE-CLOCK ANALGESIC IS
NEEDED FOR AN EXTENDED PERIOD OF TIME
TREATMENT OF MIGRAINE
USE AS AN ANTIMYCOTIC AGENT
TOPICAL TREATMENT OF OCULAR HYPERTENSION AND GLAUCOMA

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 33 of 51

PATENT USE
U-447
U-448

U-449
U-450

U-451
U-452
U-453
U-454

U-455
U-456
U-457
U-458
U-459
U-460
U-461
U-462
U-463
U-464
U-465
U-466
U-467
U-468
U-469
U-470
U-471
U-472
U-473
U-474

U-475
U-476

U-477

U-478

U-479
U-480
U-481
U-482
U-483
U-484
U-485

METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE
EVENING OR AT NIGHT
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
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 SQUARE METER
INTERMEDIATE REL NICOTINIC ACID FORMULATIONS HAVING UNIQUE URINARY METAB PROFILES
RESULTING FROM ABSORPTION PROFILES OF NICOTINIC ACID FROM THE INTERMEDIATE NICOTINIC
ACID FORMULATIONS,SUITABLE FOR TX HYPERLIPIDEMIA FOLLOWING QD DOSING
TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER
USE OF LANSOPRAZOLE FOR COMBATTING DISEASES CAUSED BY THE GENUS CAMPYLOBACTER
(C.PYLORI=H.PYLORI)
TREATMENT OF PLATELET ASSOCIATED ISCHEMIC DISORDERS
METHOD OF TX A PT SUSPECTED OF HAVING HEPATITIS C BY ADMIN, IN COMBINATION, A 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
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
METHOD OF TREATING A VAGINAL FUNGAL INFECTION IN A FEMALE HUMAN
METHOD OF USE OF IMAGENT
TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER
METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS USING
SERTRALINE
METHOD OF TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER (PMDD) USING SERTRALINE
SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND ADULT RHEUMATOID ARTHRITIS AND TREATMENT OF
PRIMARY DYSMENORRHEA
VENOGRAPHY
PERIPHERAL ARTERIOGRAPHY
CT IMAGING OF THE HEAD
TREATMENT OF IRRITABLE BOWEL SYNDROME
USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR
FOR TREATING HYPERTENSION
METHOD OF USING FEXOFENADINE HCL IN TREATING ALLERGIC RHINITIS
TREATMENT OF GASTROESOPHAGEAL REFLEX DISEASE (GERD) AND ERADICATION OF H.PYLORI TO
REDUCE RISK OF DUODENAL ULCER RECURRENCE
THERAPY IN CHRONIC HEPATITIS B VIRUS INFECTION
METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL
RELEASE PROFILE EXTENDED-RELEASE CAPSULES
TO REDUCE PLASMA CHOLESTEROL LEVELS IN A MAMMAL
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
TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE
REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
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
METHOD OF INHIBITING 5 ALPHA TESTOSTERONE REDUCTASE ENZYME WITH DUTASTERIDE OR ITS
DERIVATIVE AND TREATING ANDROGEN RESPONSIVE/MEDIATED DISEASE INCLUDING BENIGN PROSTATIC
HYPERPLASIA
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
METHOD OF USING PEG-INTRON/REBETOL COMBINATION THERAPY AND INTRON/REBETOL COMBINATION
THERAPY
CONTRAST AGENT FOR MRI
DISUBSTITUTED ACETYLENES BEARING HETEROAROMATIC AND HETEROBICYCLIC GROUPS HAVING
RETINOID-LIKE ACTIVITY
METHOD OF IN VITRO FERTILIZATION THERAPY INCLUDING MEANS FOR INDUCING OVULATION....
METHOD FOR THE ADMINISTRATION OF DRUGS USING THAT COMPOUND
METHOD OF TREATING A SKIN DISEASE WITH A CORTICOSTEROID-CONTAINING PHARMACEUTICAL
COMPOSITION
METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES (HERPES
ZOSTER AND POST-HERPETIC NEURALGIA)

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 34 of 51

PATENT USE
U-486
U-487
U-488
U-489
U-490
U-491
U-492

U-493
U-494
U-495
U-496
U-497
U-498
U-499

U-500
U-501
U-502
U-503
U-504
U-505
U-506

U-507
U-508
U-509
U-510

U-511
U-512
U-513
U-514
U-515
U-516
U-517
U-518
U-519
U-520
U-521
U-522
U-523
U-524
U-525
U-526
U-527
U-528
U-529
U-530

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
METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES (HERPES
ZOSTER AND POST-HERPETIC NEURALGIA)
METHOD FOR REDUCING THE PAIN ASSOCIATED WITH HERPES-ZOSTER AND POST-HERPETIC NEURALGIA
EXPECTORANT
TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR
ABSENCE OF ENDOGENOUS TESTOSTERONE
METHOD OF DELIVERING A DRUG TO THE LUNG
METHOD FOR THE TREATMENT OF SKIN, SUFFERING FROM A CONDITION SELECTED FROM A GROUP
CONSISTING OF NONACNE INFLAMMATORY DERMATOSES... COMPRISING APPLYING TO AFFECTED AREA. A
THERAPEUTICALLY EFFECTIVE AMT AZELAIC ACID
TREATMENT OF TYPE 2 DIABETES MELLITUS
TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER
PERITONEAL DIALYSIS SOLUTION
METHOD FOR TREATING CHRONIC RENAL FAILURE
RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS
INTRA-ARTERIAL AND INTRAVENOUS USES OF ULTRAVIST
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
USE AS AN ANTIHYPERTENSIVE AGENT
TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS
PITYRIASIS VERSICOLOR
GENERATOR MUST BE USED WITH INFUSION SYSTEM SPECIFICALLY LABELED FOR USE WITH GENERATOR
TINEA PEDIS, TINEA CRURIS, TINEA CORPORIS
ULTRASOUND CONTRAST AGENT
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
TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE
REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
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
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
PREVENTION OF OVULATION IN A WOMAN
TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES
AND HAVE DEMONSTRATED DISEASE PROGRESSION ON THE LAST THERAPY
METHOD OF TREATING A PSYCHOTIC DISEASE
STABLE GEL FORMULATION FOR TOPICAL TREATMENT OF SKIN CONDITIONS
OBSESSIVE COMPULSIVE DISORDER
POST OPERATIVE NAUSEA AND VOMITING
PREMENOPAUSAL OSTEOPOROSIS
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
METHOD OF TREATING INFECTION BY CRYPTOSPORIDIUM PARVUM IN AN IMMUNOCOMPROMISED MAMMAL
METHOD OF TREATING DIARRHEA
METHOD OF TREATING PARASITIC INFECTIONS
METHOD OF PROVIDING CONTROLLED RELEASE OF A TREATING AGENT USING A CONTROLLED RELEASE
COMPOSITION
METHOD OF DELIVERING AN ACTIVE INGREDIENT USING A PROGRESSIVE HYDRATION BIOADHESIVE
PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
ONCE DAILY TREATMENT OF ASTHMA WITH NEBULIZED BUDESONIDE
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

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 35 of 51

PATENT USE
U-531
U-532
U-533
U-534
U-535
U-536
U-537
U-538

U-539
U-540
U-541
U-542
U-543
U-544
U-545

U-546
U-547
U-548
U-549
U-550
U-551
U-552
U-553

U-554
U-555
U-556
U-557
U-558
U-559

U-560
U-561

U-562
U-563
U-564
U-565
U-566
U-567
U-568
U-569
U-570
U-571
U-572
U-573

TREATMENT OF PATIENTS WITH ESSENTIAL HYPERTENSION. MAY BE USED ALONE OR GIVEN WITH
OTHER CLASSES OF ANTIHYPERTENSIVES, ESPECIALLY THIAZIDE DERIVATIVES
TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD IN PATIENTS REQUIRING MORE THAN ONE
BRONCHO DILATOR
ERECTILE DYSFUNCTION
HUMALOG IS AN INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH
DIABETES MELLITUS FOR THE CONTROL OF HYPERGLYCEMIA
TREATMENT OF SOCIAL ANXIETY DISORDER
CONTRAST AGENT FOR MAGNETIC RESONACE IMAGING
TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND 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
TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
TREATMENT OF FUNGAL INFECTIONS
METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
METHOD OF TREATING PATIENT WITH TYPE 2 DIABETES BY ONCE DAILY ADMINISTRATION
TREATMENT OF SCHIZOPHRENIA
TREATMENT OF OVERACTIVE BLADDER. TREATMENT OF URINARY INCONTINENCE.
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
USE OF REPAGLINIDE IN COMBINATION WITH METFORMIN TO LOWER BLOOD GLUCOSE
MAINTENANCE MONOTHERAPY FOR BIPOLAR DISORDER
A METHOD OF REDUCING FLUSH IN AN INDIVIDUAL BEING TREATED FOR A LIPIDEMIC DISORDER AND
EFFECTIVELY TREATING THE LIPIDEMIC DISORDER
USE IN THE TREATMENT OF MEN WITH ADVANCED SYMPTOMATIC PROSTATE CANCER
TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
METHOD FOR REDUCING TOXICITY OF ALIMTA TREATED PATIENTS BY ADMINISTERING FOLIC ACID
TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION
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
TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL AGENTS
TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND ACUTE UNCOMPLICATED PYELONEPHRITIS
USE AS ADJUNCT DIAGNOSTIC FOR SERUM THYROGLOBULIN (TG) TESTING
NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
INDICATED FOR THE RELIEF OF BRONCHOSPASM IN PATIENTS 2-12 YEARS OF AGE WITH ASTHMA
(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
METHOD OF DECREASING PARATHYROID HORMONE LEVEL;METHOD OF TREATING HYPERPARATHYROIDISM
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
TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH AIDS-RELATED KAPOSI'S SARCOMA
MARINOL IS INDICATED FOR, INTER ALIA, ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS
WITH AIDS
TREATMENT OF HIV IN CONCOMITANT THERAPY
TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS, AND CHRONIC URTICARIA
FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
METHOD OF TREATING INFERTILITY
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
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
INTENSIVE CARE UNIT SEDATION
TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL)

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 36 of 51

PATENT USE
U-574

U-575
U-576
U-577
U-578

U-579
U-580
U-581
U-582

U-583

U-584
U-585
U-586

U-587
U-588

U-589

U-590

U-591
U-592
U-593
U-594
U-595
U-596
U-597
U-598
U-599
U-600
U-601
U-602

U-603
U-604
U-605

U-606

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
LOTEMAX OPTHALMIC SUSPENSION IS INDICATED FOR THE TREATMENT OF STEROID RESPONSIVE
CONDITIONS OF THE PALPEBRAL BULBAR CONJUNCTIVA, CORNEA AND ANTERIOR SEGMENT OF THE GLOBE.
ALREX OPTHALMIC SUSPENSION IS INDICATED FOR THE TEMPORARY RELIEF OF THE SIGNS AND
SYMPTOMS OF SEASONAL ALLERGIC CONJUNCTIVITIS.
TREATMENT OF BENIGN PROSTATIC HYPERPLASIA WITH FINASTERIDE IN COMBINATION WITH DOXAZOSIN
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.
TREATMENT OF EPILEPSY AND/OR MIGRAINE.
TREATMENT OF DISORDERS OF THE SEROTONERGIC SYSTEM SUCH AS DEPRESSION AND ANXIETY-RELATED
DISORDERS
METHOD OF TREATING A CONDITION CAPABLE OF TREATMENT BY INHALATION, E.G. ASTHMA,
COMPRISING ADMINISTRATION OF A FORMULATION CLAIMED IN US PATENT NO. 6743413
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
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
SINGLE-DOSE ADMINISTRATION BY THE EPIDURAL ROUTE, AT THE LUMBAR LEVEL, FOR THE TREATMENT
OF PAIN FOLLOWING MAJOR SURGERY
TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
AN INTERMEDIATE RELEASE NICOTINIC ACID FORMULATION SUITABLE FOR ORAL ADMINISTRATION ONCEA-DAY AS A SINGLE DOSE FOR TREATING HYPERLIPIDEMIA WITHOUT CAUSING DRUG-INDUCED
HEPATOTOXICITY OR ELEVATIONS IN URIC ACID OR GLUCOSE OR BOTH
USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR
(AND OPTIONALLY A DIURETIC) FOR TREATING CONGESTIVE HEART FAILURE AND HYPERTENSION
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
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
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
TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING A DOSAGE FORM WHICH PROVIDES
ONCE-DAILY ORAL ADMINISTRATION OF A PHENIDATE DRUG
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
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
TREATMENT OF HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN
WITH DISEASE PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE
AT HIGH RISK FOR FRACTURE
PROPHYLACTIC TREATMENT OF MIGRAINE
METHOD FOR TREATING ALLERGIC CONJUNCTIVITIS
A METHOD OF TREATING A PATIENT IN NEED OF OPHTHALMIC ANTIMICROBIAL THERAPY WITH
LEVOFLOXACIN
TREATMENT OF BIPOLAR DISORDER
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
METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
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
USE OF IRINOTECAN IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF
METASTATIC COLRECTAL CANCER

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PATENT AND EXCLUSIVITY TERMS

ADB 37 of 51

PATENT USE
U-607
U-608
U-609
U-610

U-611
U-612
U-613
U-614
U-615

U-616

U-617
U-618

U-619
U-620
U-621
U-622
U-623
U-624
U-625
U-626
U-627
U-628
U-629
U-630
U-631
U-632
U-633

U-634

U-635
U-636
U-637
U-638
U-639
U-640
U-641
U-642
U-643

U-644
U-645
U-646
U-647

CANCIDAS IS INDICATED FOR EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE,
NEUTROPENIC PATIENTS.
USE OF QUINOLONE COMPOUNDS AGAINST PNEUMOCOCCAL PATHOGENIC BACTERIA
USE OF QUINOLONE COMPOUNDS AGAINST QUINOLONE-RESISTANT PNEUMOCOCCAL PATHOGENIC BACTERIA
ATROVENT HFA (IPRATROPIUM BROMIDE HFA) INHALATION AEROSOL IS INDICATED AS A
BRONCHODILATOR FOR MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC
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
REDUCTION OF SERUM PHOSPHATE
TREATMENT OF SEXUAL DYSFUNCTION
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
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
TREATMENT OF INSOMNIA
METHOD OF TREATING CANCER
TREATMENT OF VEGF MEDIATED OCULAR DISEASE.
SHORT TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
REDUCTION OF RISK OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
ALLERGIC RHINITIS OR NASAL POLYPS
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
TREATMENT OF PATIENTS USING EXTENDED-RELEASE CARBAMAZEPINE
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
METHOD OF INDUCING A HYPNOTIC OR SEDATIVE EFFECT IN A HUMAN BY ADMINISTERING ESZOPICLONE
TREATING URINARY INCONTINENCE BY ADMINISTERING AN EXTENDED-RELEASE FORM OF DARIFENACIN
TREATING A DISEASE OF ALTERED MOTILITY OR TONE OF SMOOTH MUSCLE BY ADMINISTERING A
MUSCARINIC RECEPTOR ANTAGONIZING AMOUNT OF DARIFENACIN
METHOD OF TREATMENT OF CANCER BY ADMINISTERING PARTICLES OF PACLITAXEL THAT HAVE A
PROTEIN COATING
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
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
TREATMENT OF GERD, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND RISK REDUCTION OF
NSAID ASSOCIATED GASTRIC ULCERS
TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS
TREATMENT OF DIABETES WITH AN AMYLIN AGONIST
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
USE OF AN AMYLIN AGONIST TO REDUCE GASTRIC MOTILITY AND TREAT POST PRANDIAL HYPERGYLCEMIA
USE OF AN AMYLIN AGONIST HAVING SPECIFIED BINDING ACTIVITY TO REDUCE GASTRIC MOTILITY,
INCLUDING USE THROUGH PARENTERAL ADMINISTRATION
TREATMENT AND PREVENTION OF OSTEOPOROSIS
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
TREATMENT OF SEASONAL ALLERGIC RHINITIS
TREATMENT OF ASTHMA
METHOD OF TREATING OTITIS
TREATMENT OF OSTEOPOROSIS IN POST MENOPAUSAL WOMEN AND/OR THE TREATMENT TO INCREASE BONE
MASS IN MEN WITH OSTEOPOROSIS

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PATENT AND EXCLUSIVITY TERMS

ADB 38 of 51

PATENT USE
U-648
U-649
U-650
U-651
U-652
U-653
U-654
U-655

U-656
U-657
U-658
U-659
U-660
U-661
U-662
U-663
U-664
U-665
U-666
U-667
U-668
U-669
U-670
U-671
U-672
U-673
U-674
U-675
U-676
U-677
U-678
U-679
U-680

U-681
U-682
U-683
U-684
U-685
U-686
U-687
U-688
U-689
U-690

THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND/OR THE TREATMENT TO INCREASE

BONE MASS IN MEN
A METHOD FOR TREATING A TUMOR DISEASE
TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT
PATIENTS
TREATMENT OF ACUTE PROMYELOCYTIC LEUKEMIA (APL)
TREATMENT OF CARDIAC ARRHYTHMIA
STIMULATING INSULIN RELEASE BY ADMINISTERING EXENATIDE
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 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 EXENDIN, SUCH
AS EXENDIN-4
PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
TREATMENT OF ADVANCED HORMONE-DEPENDENT BREAST CANCER
TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) AFTER
FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
TREATMENT OF HYPERTENSION AND TREATMENT OF HEART FAILURE
TREATMENT OF SEIZURE DISORDER
TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
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
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
INDICATION OF TYPE II DIABETES
TREATMENT OF HIV-1 INFECTION BY THE CO-ADMINISTRATION OF TIPRANAVIR AND RITONAVIR.
PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY
DISEASE (CKD) STAGE 3 AND 4
TREATMENT OF INFLAMMATION OR AN INFLAMMATION-ASSOCIATED DISORDER
METHOD OF TREATMENT WITH ONCE-DAILY DOSES OF 625MG/5ML
METHOD OF TREATING INSOMNIA CHARACHTERIZED BY DIFFICULTY WITH SLEEP ONSET
PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA; RELIEF OF SYMPTOMS OF ALLERGIC RHINITIS
METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR
PULSATILE RELEASE COMPOSITION
A METHOD OF TREATING DISEASE AMENABLE TO TREATMENT WITH A PHENIDATE DRUG BY ONCE DAILY
ORAL ADMINISTRATION OF AN EXTENDED RELEASE DOSAGE FORM
METHOD OF TREATING ATTENTION DEFICIT DISORDER AND/OR ATTENTION DEFICIT HYPERACTIVITY
DISORDER
ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
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
TREATMENT OF PRIMARY IGF-1 DEFICIENCY
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
TREATMENT OF UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN ADULTS
AND CHILDREN 6 YEARS OF AGE AND OLDER
EXPECTORANT AND COUGH SUPPRESSANT
EXPECTORANT AND NASAL DECONGESTANT
REDUCING FOOD INTAKE IN A SUBJECT WITH TYPE 2 DIABETES BY ADMINISTERING AN EXENDIN, SUCH
AS EXENDIN-4
TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA WHOSE DISEASE HAS NOT
RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY REGIMENS
TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

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PATENT AND EXCLUSIVITY TERMS

ADB 39 of 51

PATENT USE
U-691

U-692
U-693

U-694

U-695

U-696
U-697
U-698
U-699
U-700
U-701
U-702
U-703
U-704
U-705
U-706
U-707
U-708
U-709
U-710

U-711
U-712
U-713
U-714
U-715
U-716

U-717
U-718
U-719
U-720
U-721
U-722
U-723
U-724
U-725
U-726
U-727
U-728
U-729
U-730
U-731
U-732

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
USE OF VALSARTAN TO REDUCE CARDIOVASCULAR MORTALITY IN CLINICALLY STABLE PATIENTS WITH
LEFT VENTRICULAR FAILURE OR LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION
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.
LENALIDOMIDE IS AN ANALOGUE OF THALIDOMIDE. THALIDOMIDE IS A KNOWN HUMAN TERATOGEN THAT
CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF LENALIDOMIDE IS TAKEN 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
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
A METHOD OF USING RINFABATE RECOMBINANT (RHIGFBP-3) WITH MECASERMIN RECOMBINANT (RHIGF1) 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
NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
TREATMENT OF HYPERCHOLESTEROLEMIA AND/OR HYPERTRIGLYCERIDEMIA
TOPICAL AEROSOL HAIR REGROWTH TREATMENT
TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL TUMOR
AND RENAL CELL CARCINOMA WITH SUNITINIB
METHOD OF ADMINISTERING INSULIN VIA INHALATION
TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE
TREATMENT OF BENIGN PROSTATIC HYPERPLASIA
ALLERGIC RHINITIS
TREATMENT OF CHRONIC NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE
METHOD OF COMBATING BACTERIA IN A PATIENT
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
ACUTE AND LONGER-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER
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
TOPICAL TREATMENT OF INTERDIGITAL TINEA PEDIS AND TINEA CORPORIS DUE TO TRICHOPHYTON
RUBRUM, TRICHOPHYTON MENTAGROPHYTES OR EPIDERMOPHYTON FLOCCOSUM
FOR CLEANSING THE BOWEL IN PREPARATION FOR COLONOSCOPY, IN ADULTS 18 YEARS OF AGE OR
OLDER
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 EXERCISEDINDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
TREATMENT OF FUNGAL INFECTIONS
TREATENT OF PSYCHOSIS
TREATMENT OF NEUROLEPTIC DISEASES
TREATMENT OF INFLUENZA
PROPHYLAXIS OF INFLUENZA
PROPHYLACTIC TREATMENT OF MIGRAINE
METHOD OF TREATING SEIZURES
ALLERGIC RHINITIS AND URTICARIA
ALLERGIC RHINITIS
FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
METHOD FOR TREATING BACTERIAL INFECTION
TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), RISK-REDUCTION OF NSAID-ASSOCIATED
GASTRIC ULCER, H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
USE AS A NASAL SPRAY FOR TREATMENT OF THE SYMPTOMS OF SEASONAL ALLERGIC RHINITIS AND
VASOMOTOR RHINITIS
USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH
NEWLY DIAGNOSED MULTIPLE MYELOMA
ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM
LEPROSUM (ENL)

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 40 of 51

PATENT USE
U-733
U-734
U-735
U-736
U-737
U-738
U-739
U-740
U-741
U-742
U-743
U-744
U-745
U-746
U-747
U-748
U-749
U-750
U-751
U-752
U-753
U-754
U-755
U-756
U-757
U-758
U-759
U-760
U-761
U-762
U-763
U-764
U-765
U-766
U-767
U-768

U-769
U-770
U-771
U-772

U-773
U-774
U-775
U-776

U-777
U-778
U-779
U-780

MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL
RECURRENCE
FIRST LINE THERAPY FOR TYPE 2 DIABETES MELLITUS
METHOD OF TREATING CHRONIC IRON OVERLOAD
METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
INDICATED FOR THE LONG-TERM, TWICE-DAILY MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12
YEARS OF AGE OR OLDER
METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMALIAN SUBJECT
FOR THE TREATMENT OF PATIENTS WITH PRIMARY BILIARY CIRRHOSIS
COMBINATION THERAPY WITH CISPLATIN FOR THE TREATMENT OF LATE STAGE CERVICAL CANCER
TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS.
ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
TREATMENT OF HIV INFECTION IN ANTIRETROVIRAL TREATMENT-EXPERIENCED ADULT PATIENTS
TREATMENT OR PREVENTION OF EMESIS
PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC AGENT
PREVENTION OR TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
A METHOD FOR THE TREATMENT OF A PROTEIN TYROSINE KINASE-ASSOCIATED DISORDER
METHOD OF CONTRACEPTION
TREATMENT OF HIV-1 INFECTION IN ADULTS
ONCE DAILY DOSING OF BUDESONIDE VIA NEBULIZER FOR THE TREATMENT OF ASTHMA
SUNSCREEN
AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES
USE FOR THE LONG-TERM MAINTENANCE TREATMENT OF ASTHMA
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
USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL
TREATMENT OF SYMPTOMS OF PREMENSTRUAL DYSPHORIC DISORDER
METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS AND TREATMENT OF
OROPHARYNGEAL CANDIDAIASIS
TREATMENT OF SCHIZOPHRENIA INCLUDING MAINTAINING STABILITY IN PATIENTS WITH SCHIZOPHRENIA
TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
ADMINISTRATION OF ARIPIPRAZOLE BY INJECTION
TREATMENT OF SCHIZOPHRENIA
METHOD OF TREATING ALLERGIC CONJUNCTIVITIS
TREATMENT OF SEIZURES
MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
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
REVLIMID (LENALIDOMIDE) IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT
OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEASET ONE PRIOR THERAPY
LONG-TERM TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS
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
PATHOLOGICAL HYPERSECRETORY CONDITIONS
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASTE-IV
INHIBITOR
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV
INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
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.
DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE
REDUCTION OF ELEVATED INTRAOCULAR PRESSUE IN PATEINTS WITH OPEN ANGLE GLAUCOME OR OCULAR
HYPERTENSION
A METHOD FOR TREATMENT OF A CANCER, WHEREIN THE CANCER IS CHRONIC MYELOGENOUS LEUKEMIA
A METHOD FOR THE TREATMENT OF CANCER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 41 of 51

PATENT USE
U-781
U-782

U-783
U-784
U-785
U-786
U-787

U-788
U-789
U-790

U-791
U-792
U-793

U-794

U-795
U-796
U-797
U-798
U-799
U-800

U-801
U-802
U-803
U-804
U-805
U-806
U-807
U-808
U-809
U-810
U-811
U-812
U-813
U-814
U-815
U-816
U-817
U-818
U-819
U-820

FOR TREATMENT OF ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE NAIVE TO
PHARMACOLOGIC THERAPY
TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL REPLICATION
AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM 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
TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)
USE AS REPLACEMENT SOLUTION, HEMOFILTRATION SOLUTION OR HEMODIAFILTRATION SOLUTION IN
CONTINUOUS RENAL REPLACEMENT THERAPY
PRODUCT IS APPROVED FOR THE TOPICAL TREATMENT OF TINEA PEDIS
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
METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS USING
PAROXETINE
TREATMENT OF KNOWN OR SUSPECTED CYANIDE POISONING
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
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
FOR THE LONG TERM TREATMENT, TWICE DAILY (MORNING AND EVENING) MAINTENANCE TREATMENT OF
BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY 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
METHOD FOR INHIBITING NOREPINEPHRINE UPTAKE
METHOD OF TREATING DEPRESSION
METHOD OF TREATING ANXIETY
TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN BY ONCE-MONTHLY ORAL
ADMINISTRATION OF IBANDRONATE SODIUM MONOHYDRATE EQUIVALENT TO 150MG OF IBANDRONIC ACID
METHOD FOR INHIBITING SEROTONIN UPTAKE
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
METHOD OF TREATING CANCER
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV
INHIBITOR
METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV
INHIBITOR IN COMBINATION WITH METFORMIN
TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY
TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES
INTRATHECAL TREATMENT OF LYMPHOMATOUS MENINGITIS
PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION
THE TREATMENT OF THE SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN PATIENTS 2
YEARS OF AGE AND OLDER
TREATMENT OF CHRONIC IDIOPATHIC URTICARIA
METHOD OF TREATMENT TO ALLEVIATE INFLAMMATION OF THE EYE
RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS AND
TREATMENT OF THE UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA
RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
MAINTENANCE TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE
PULMONARY DISEASE (COPD)
TREATMENT OF SCHIZOPHRENIA
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
TOPICAL TREATMENT OF ACNE VULGARIS
MANAGEMENT OF FIBROMYALGIA
IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE SLEEPINESS ASSOCIATED WITH NARCOLEPSY,
OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME, AND SHIFT WORK SLEEP DISORDER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 42 of 51

PATENT USE
U-821
U-822
U-823

U-824
U-825
U-826
U-827
U-828
U-829
U-830
U-831
U-832
U-833
U-834
U-835
U-836
U-837
U-838
U-839
U-840
U-841
U-842
U-843
U-844

U-845
U-846
U-847

U-848
U-849

U-850
U-851
U-852
U-853
U-854
U-855
U-856

U-857
U-858
U-859

U-860
U-861

METHOD OF INHIBITING ENTHOTHELIN RECEPTORS BY ADMINISTERING AMBRISENTAN TO A PATIENT TO

TREAT PULMONARY ARTERIAL HYPERTENSION.
USE IN LIPID MANAGEMENT
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
METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1
USE FOR PREVENTION OF BREAST CANCER
RELIEF OF MODERATE TO SEVERE PAIN
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
TREATMENT OF EXTRAVASATION RESULTING FROM IV ANTHRACYCLINE CHEMOTHERAPY
TREATMENT OF RELAPSED SMALL CELL LUNG CANCER
METHOD OF ADMINISTERING LANREOTIDE ACETATE
ZINGO IS INDICATED FOR THE USE ON INTACT SKIN TO PROVIDE LOCAL ANALGESIA PRIOR TO
VENIPUNCTURE OR INTRAVENOUS CANNULATION.
METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE AND
ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.25% BY WEIGHT OF ROPIVACAINE
INVIRASE IN COMBINATION WITH RITONAVIR AND OTHER ANTIRETROVIRAL AGENTS IS INDICATED FOR
THE TREATMENT OF HIV INFECTION
RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF ATOPIC DERMATITIS IN PATIENTS
ONE YEAR OF AGE OR OLDER
A METHOD FOR THE TREATMENT OF LEUKEMIAS
GASTROINTESTINAL LAVAGE INDICATED FOR CLEANSING OF THE COLON AS A PREPARATION FOR
COLONOSCOPY IN ADULTS
METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE AND
ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.5% BY WEIGHT OF ROPIVACAINE
TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
TREATMENT FOR TYPE 2 DIABETES MELLITUS
INDICATED FOR THE LONG-TERM, MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE
AND OLDER
INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
METHOD FOR ADMINISTRATION OF TESTOSTERONE
PREFEST IS INDICATED IN WOMEN WHO HAVE A UTERUS FOR THE TREATMENT OF MODERATE TO 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
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
(TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
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
PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC AGENT
TREATMENT OF TYPE 2 DIABETES MELLITUS
RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
TREATMENT OR PREVENTION OF EMESIS
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
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
INHIBITION OF TRANSPLANT REJECTION
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
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

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 43 of 51

PATENT USE
U-862

U-863
U-864
U-865
U-866
U-867
U-868
U-869
U-870
U-871
U-872

U-873
U-874
U-875
U-876
U-877
U-878
U-879
U-880

U-881
U-882
U-883
U-884
U-885
U-886
U-887
U-888
U-889
U-890
U-891
U-892
U-893
U-894
U-895
U-896
U-897
U-898
U-899
U-900
U-901
U-902
U-903
U-904
U-905

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
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
THE LABEL REFERENCES THE EFFECTS OF THE ACTIVE INGREDIENT OF REVLIMID UPON CYTOKINES
TREATMENT OF MIGRAINE
METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR
INTRAVENOUS TREATMENT OF PATIENTS WITH HYPERVOLEMIC HYPONATREMIA
METHOD FOR STIMULATING CORONOARY VASODILATION FOR PURPOSES OF IMAGING THE HEART
METHOD OF PRODUCING CORONARY VASODILATION WITHOUT PERIPHERAL VASODILATION
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
METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME BY OPENING
CHLORIDE CHANNELS (CIC)
METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME
FIRST-LINE TREATMENT OF LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC CANCER,
IN COMBINATION WITH GEMCITABINE
TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PEPTIC ULCER
A METHOD FOR BINDING A PERIPHERAL OPIOID RECEPTOR
A METHOD OF TREATING OR PREVENTING ILEUS
ENDOMETRIN IS A PROGESTERONE INDICATED TO SUPPORT EMBRYO IMPLANTATION AND EARLY
PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED
REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN
TREATMENT OF NON-SMALL CELL LUNG CANCER
MANAGEMENT OF FIBROMYALGIA (FM)
TREATMENT OF GASTROINTESTINAL STROMAL TUMOR WITH SUNITINIB
TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR
THERAPY
ADMINISTERING DESLORATADINE TO TREAT THE SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS,
SEASONAL ALLERGIC RHINITIS, OR CHRONIC IDIOPATHIC URTICARIA
TREATMENT AND PREVENTION OF OSTEOPOROSIS
FEMALE HORMONE REPLACEMENT THERAPY FOR POSTMENOPAUSAL WOMEN
MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCCIATED WITH
MENOPAUSE)
REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
USE AS AN INTRAOCULAR IRRIGATING SOLUTION DURING SURGICAL PROCEDURES INVOLVING PERFUSION
OF THE EYE
TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA (CTCL)
CLEVIPREX IS A DIHYDROPYRIDINE CALCIUM CHANNEL BLOCKER INDICATED FOR THE REDUCTION OF
BLOOD PRESSURE WHEN ORAL THERAPY IS NOT FEASIBLE OR NOT DESIRABLE
TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER
TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS AND
CHILDREN TWO YEARS OF AGE AND OLDER
METHOD OF TREATING TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS PYOGENES IN
A ONCE-A-DAY AMOXICILLIN PRODUCT
USE OF GLUTAMINE TOGETHER WITH GROWTH HORMONE FOR THE TREATMENT OF PATIENTS WITH SHORT
BOWEL SYNDROME
USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH
NEWLY DIAGNOSED MULTIPLE MYELOMA
INTEGRASE INHIBITION FOR THE TREATMENT OF HIV INFECTION
PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
USE IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA (BPH)
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN ADULT PATIENTS
TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF
VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 44 of 51

PATENT USE
U-906

U-907
U-908
U-909
U-910
U-911
U-912
U-913
U-914
U-915
U-916
U-917
U-918
U-919
U-920

U-921
U-922
U-923
U-924
U-925
U-926

U-927
U-928
U-929
U-930
U-931
U-932

U-933

U-934

U-935

U-936

U-937
U-938
U-939
U-940
U-941
U-942
U-943
U-944
U-945
U-946

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
PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS RECEIVING ALLOGENEIC RENAL TRANSPLANTS
TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
TREATMENT OF METASTATIC CARCINOMA OF THE OVARY AFTER FAILURE OF INITIAL OR 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
SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER PROCEDURES
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
TREATMENT OF MUSCULOSKELETAL CONDITIONS
TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE
TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET
FOR THE TREATMENT OF DERMATITIS
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
TREATMENT OF ACNE VULGARIS
FOR THE TREATMENT OF FUNGAL INFECTIONS
METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION
TREATMENT OF MILD TO MODERATE INFECTION CAUSED ABY SUSCEPTIBLE STRAINS
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
TREATMENT OF BACTERIAL INFECTIOUS DISEASE
TREATMENT OF OBSESSIVE COMPULSIVE DISORDER TREATABLE WITH AN SSRI
TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
RELIEF OF MODERATE TO SEVERE ACUTE PAIN
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
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
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
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
USE IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE
HEMATOPOIETIC STEM CELLS TO PERIPHERAL BLOOD FOR COLLECTION & SUBSEQUENT AUTOLOGOUS
TRANSPLANTATION IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA & MULTIPLE MYELOMA
TREATMENT OF PROSTATE CANCER
TREATMENT OF HAIR LOSS AND HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR GROWTH
INCLUDING LENGTH, THICKNESS AND DARKNESS
TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING AND STIMULATING THEIR GROWTH
INCLUDING LENGTH, THICKNESS AND DARKNESS
METHOD TO TREAT AIDS-RELATED KAPOSI'S SARCOMA
METHOD TO TREAT OVARIAN CANCER
METHOD TO TREAT MULTIPLE MYELOMA
GNRH ANTAGONIST INDICATED FOR TREATMENT OF PATIENTS WITH ADVANCED PROSTATE CANCER
TREATMENT OF PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
SEDATIVE-HYPNOTIC AGENT INDICATED FOR MONITORED ANESTHESIA CARE (MAC) SEDATION
TREATMENT OF BREAST CANCER

32ND EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

PATENT AND EXCLUSIVITY TERMS

ADB 45 of 51

PATENT USE
U-947

U-948
U-949
U-950
U-951
U-952
U-953
U-954
U-955
U-956
U-957
U-958

U-959

U-960
U-961
U-962
U-963
U-964
U-965
U-966
U-967

U-968
U-969
U-970
U-971
U-972
U-973

U-974
U-975
U-976
U-977
U-978
U-979
U-980
U-981

U-982
U-983
U-984
U-985
U-986

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
TREATMENT OF DIABETES MELLITUS
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
(GERD) FOR 4 WEEKS
USE AS AN ANALGESIC
METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION
CHRONIC MANAGEMENT OF HYPERURICEMIA IN PATIENTS WITH GOUT. NOT RECOMMENDED FOR THE
TREATMENT OF ASYMPTOMATIC HYPERURICEMIA
PROPHYLACTIC TREATMENT OF MIGRAINE
TREATMENT OF PATIENTS WITH H. PYLORI INFECTION AND DUODENAL ULCER DISEASE
A METHOD OF TREATING CANCER IN A PATIENT COMPRISING ADMINISTERING IXABEPILONE OR
PHARMACEUTICAL COMPOSITIONS COMPRISING IXABEPILONE
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
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
METHOD OF TREATING BREAST CANCER BY ADMINISTERING IXABEPILONE; A METHOD OF TREATING A
CANCER RESPONSIBLE TO MICROTUBULE STABILIZATION BY ADMINISTERING IXABEPILONE
SYMBYAX IS INDICATED FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS
PROZAC AND OLANZAPINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT
DEPRESSION IN ADULTS
ZYPREXA ZYDIS AND FLUOXETINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT
RESISTANT DEPRESSION IN ADULTS
USE OF IXABEPILONE IN COMBINATION WITH CAPECITABINE IN TREATMENT OF METASTASIS BREAST
CANCER
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
A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
TREATMENT OF MIGRAINE
TOPICAL TREATMENT OF LICE INFESTATIONS
INDICATED FOR THE ACUTE TREATMENT OF ADULTS WITH SCHIZOPHRENIA
MONOTHERAPY OR AS ADJUNCTIVE THERAPY TO LITHIUM OR VALPROATE FOR THE MAINTENANCE
TREATMENT OF BIPOLAR I DISORDER
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 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
TREATMENT OF PULMONARY HYPERTENSION
IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
TREATMENT OF ACUTE, UNCOMPLICATED MALARIA INFECTION DUE TO PLASMODIUM FALCIPARUM IN
PATIENTS OF 5KG BODYWEIGHT AND ABOVE
METHOD OF TREATING HYPONATREMIA
RELIEF OF MUSCLE SPASM
NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
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
METHOD OF TREATING OSTEOPOROSIS IN A POST-MENOPAUSAL WOMAN AT RISK FOR FRACTURE
METHOD FOR THE TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND AT RISK FOR BONE FRACTURE
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

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PATENT AND EXCLUSIVITY TERMS

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PATENT USE
U-987
U-988
U-989
U-990
U-991
U-992
U-993
U-994
U-995
U-996

U-997
U-998

U-999
U-1000
U-1001

U-1002
U-1003
U-1004
U-1005
U-1006

U-1007
U-1008
U-1009
U-1010

U-1011
U-1012
U-1013
U-1014
U-1015
U-1016

U-1017
U-1018
U-1019
U-1020
U-1021
U-1022
U-1023
U-1024

U-1025
U-1026
U-1027
U-1028
U-1029
U-1030

TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH CHRONIC KIDNEY DISEASE ON

DIALYSIS
TREATMENT OF RHINITIS COMPRISING THE NASAL APPLICATION OF A PHARMACEUTICAL FORMULATION
AS CLAIMED IN US PATENT 7541350
FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
TREATMENT OF PROTOZOAL INFECTION
TREATMENT OR PROPHYLAXIS OF THROMBOSIS OR EMBOLISMS
REDUCTION OF THE RISK OF CARDIOVASCULAR HOSPITALIZATION
METHOD OF TREATING INFERTILITY
METHOD OF TREATMENT OF OSTEOPOROSIS WHEREIN THE OSTEOPOROSIS IS STEROID-INDUCED
METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN
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
TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
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
TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS
METHOD FOR DELIVERING DRUG TO LUNG OF MAMMAL, COMPRISING ADMINISTERING DRUG PRODUCT BY
INHALATION. TREATING A MAMMAL HAVING A CONDITION CAPABLE OF TREATMENT BY INHALATION,
COMPRISING ADMINISTERING TO THE LUNG THE DRUG PRODUCT BY INHALATION
METHOD OF TREATING INFLAMMATORY CONDITIONS
A METHOD OF MYOCARDIAL PERFUSION IMAGING AND INCREASING CORONARY BLOOD FLOW
TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
METHOD OF TREATING A STAPHYLOCOCCAL INFECTION
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
APPLICATION OF ANTISEPTIC WITH MOISTURIZERS FOR SURGICAL AND HEALTHCARE PERSONNEL SKIN
DISINFECTION
METHOD FOR ADMINISTRATION OF TESTOSTERONE
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
USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA AND
VOMITING
METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG INTERACTION
METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT
PATIENTS WITH CHRONIC HEPATITIS C
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
IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN
TREATMENT-EXPERIENCED ADULT PATIENTS, WHO HAVE EVIDENCE OF VIRAL REPLICATION AND HIV-1
STRAINS RESISTANT TO AN NNRTI AND OTHER ANTIRETROVIRAL AGENTS
A METHOD OF TREATING NASAL AND NON-NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
TREATMENT OF PULMONARY HYPERTENSION BY INHALATION
TREATMENT OF PULMONARY HYPERTENSION
METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
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
TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR
HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY
CONTROLLED IOP
TREATING FREQUENT HEARTBURN
A METHOD OF TREATING HUMAN SUFFERING FROM OR SUSCEPTIBLE TO PSYCHOSIS.
REDUCTION OF ELEVATED PLASMA STEROL AND/OR STANOL LEVELS IN A MAMMAL
A METHOD OF DISTRIBUTING SODIUM OXYBATE UNDER CONTROL OF A CENTRAL PHARMACY
METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED THEREOF
IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)

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PATENT AND EXCLUSIVITY TERMS

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PATENT USE
U-1031 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 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN ADULTS
U-1035 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 TREATMENT OF BIOPSY-CONFIRMED, PRIMARY SUPERFICIAL BASAL CELL CARCINOMA (SBCC)
U-1048 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
MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
U-1055 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2
DIABETES MELLITUS WHO ARE ALREADY TREATED WITH A THIAZOLIDINEDIONE (TZD) AND METFORMIN
OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A TZD OR METFORMIN ALONE
U-1056 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 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 TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
U-1064 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 THE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A CONTINUOUS,
AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME
U-1073 USE FOR THE TREATMENT OF ASTHMA AND COPD

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PATENT AND EXCLUSIVITY TERMS

ADB 48 of 51

PATENT USE
U-1074 USE OF EXENATIDE MAY RESULT IN REDUCTION IN BODY WEIGHT
U-1075 USE FOR THE TREATMENT OF ASTHA
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
ADMINISTRAION
U-1078 TREATMENT OF ACNE
U-1079 REVLIMID (LENALIDOMIDE) IS INDICATED FOR THE TREATMENT OF PATIENTS WITH TRANSFUSIONDEPENDENT ANEMIA IN MYELODYSPLASTIC SYNDROMES (MDS)
U-1080 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 METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA
U-1099 TREATMENT OF PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL
NEUROPATHY, POSTHERPETIC NEURALGIA, AND FIBROMYALGIA
U-1100 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 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 EDUCATION AND
PRESCRIBING SAFETY" (S.T.E.P.S.)
U-1110 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

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PATENT AND EXCLUSIVITY TERMS

ADB 49 of 51

PATENT USE
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 PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION
U-1125 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 NIGHT,
WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
U-1130 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 NIGHT,
WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
U-1132 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 NIGHT,
THROUGH REDUCTION OF LDL-C, TC, TG, LP(A) AND INCREASE OF HDL-C
U-1136 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 NIGHT,
THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C
U-1138 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 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)

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PATENT AND EXCLUSIVITY TERMS

ADB 50 of 51

PATENT USE
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 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 TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
U-1180 TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHTSIDED 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 TREATMENT
OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE)
U-1188 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 BOTH
SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
U-1190 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH
SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
U-1191 METHOD OF TX TYPE 2 DM IN PTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND 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)
U-1192 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH
SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS
GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
U-1193 METHOD OF TREATING TYPE 2 DIABETES MELITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH
SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST
(SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
U-1194 METHOD FOR TREATING INSOMNIA

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PATENT AND EXCLUSIVITY TERMS

ADB 51 of 51

PATENT USE
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 INFANT USE AGED 1 MONTH TO LESS THAN ONE YEAR, GERD AND EROSIVE ESOPHAGITIS
U-1208 TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR GROWTH INCLUDING LENGTH,
THICKNESS AND DARKNESS