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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

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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

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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.

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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

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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

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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

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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

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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

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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

32nd EDITION - 2012 - APPROVED DRUG PRODUCTS LIST

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